UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
6-K
REPORT
OF FOREIGN PRIVATE ISSUER
PURSUANT
TO RULE 13a-16 OR 15d-16 OF THE SECURITIES EXCHANGE ACT OF 1934
For
the month of August 2024
Commission
File Number: 001-38064
COSCIENS
Biopharma Inc.
(Translation
of registrant’s name into English)
c/o
Norton Rose Fulbright Canada, LLP, 222 Bay Street,
Suite 3000, PO Box 53,
Toronto ON
M5K
1E7
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form
20-F ☒ Form 40-F ☐
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
Exhibits
99.1 and 99.2 included with this report on Form 6-K are hereby incorporated by reference into the Registrant’s Registration Statements
on Form S-8 (No. 333-224737, No. 333-210561 and No. 333-200834) and shall be deemed to be a part thereof from the date on which this
report is furnished, to the extent not superseded by documents or reports subsequently filed or furnished.
DOCUMENTS
INDEX
SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
|
|
AETERNA
ZENTARIS INC. |
|
|
|
|
Date:
August 13, 2024 |
|
By: |
/s/
Gilles Gagnon |
|
|
|
Gilles
Gagnon |
|
|
|
President
and Chief Executive Officer |
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Exhibit
99.1
COSCIENS
Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Condensed
Interim Consolidated Financial Statements
As
of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In
thousands of US dollars)
(Unaudited)
COSCIENS
Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Condensed
Interim Consolidated Statements of Financial Position
(In
thousands of US dollars)
(Unaudited)
| |
| | | |
| | |
| |
As
of
June 30, 2024 | | |
As
of
December 31, 2023 | |
| |
$ | | |
$ | |
ASSETS | |
| | | |
| | |
Current
assets | |
| | | |
| | |
Cash and cash
equivalents | |
| 27,804 | | |
| 6,678 | |
Trade and other receivables | |
| 1,238 | | |
| 290 | |
Inventories (note 5) | |
| 3,055 | | |
| 4,009 | |
Income taxes receivable | |
| 117 | | |
| - | |
Prepaid
expenses and other assets (note 6) | |
| 994 | | |
| 290 | |
Total
current assets | |
| 33,208 | | |
| 11,267 | |
Non-current
assets | |
| | | |
| | |
Restricted cash and cash equivalents | |
| 332 | | |
| 8 | |
Investment tax credit receivable | |
| 719 | | |
| 743 | |
Property and equipment (note
7) | |
| 11,499 | | |
| 11,645 | |
Intangible assets (note 8) | |
| 3,335 | | |
| 7 | |
Deferred
tax assets | |
| 952 | | |
| 75 | |
Total
non-current assets | |
| 16,837 | | |
| 12,478 | |
Total
assets | |
| 50,045 | | |
| 23,745 | |
| |
| | | |
| | |
LIABILITIES | |
| | | |
| | |
Current
liabilities | |
| | | |
| | |
Payables and accrued liabilities
(note 9) | |
| 5,841 | | |
| 1,012 | |
Provisions | |
| 432 | | |
| - | |
Income taxes payable | |
| 108 | | |
| - | |
Current portion of deferred
revenues (note 4) | |
| 97 | | |
| - | |
Current portion of lease liabilities | |
| 407 | | |
| 299 | |
Warrant liability (note 11) | |
| 2,796 | | |
| - | |
DSU
liability (note 12) | |
| 217 | | |
| - | |
Total
current liabilities | |
| 9,898 | | |
| 1,311 | |
Non-current
liabilities | |
| | | |
| | |
Deferred revenues (note 4) | |
| 1,613 | | |
| - | |
Lease liabilities | |
| 1,280 | | |
| 1,399 | |
Employee
future benefits (note 10) | |
| 11,027 | | |
| - | |
Total
non-current liabilities | |
| 13,920 | | |
| 1,399 | |
Total
liabilities | |
| 23,818 | | |
| 2,710 | |
Shareholders’
equity | |
| | | |
| | |
Share capital (note 13) | |
| 22,002 | | |
| 13,517 | |
Contributed surplus | |
| 3,910 | | |
| 3,874 | |
Retained earnings | |
| 1,533 | | |
| 4,356 | |
Accumulated
other comprehensive loss | |
| (1,218 | ) | |
| (712 | ) |
Total
Shareholders’ equity | |
| 26,227 | | |
| 21,035 | |
Total
liabilities and shareholders’ equity | |
| 50,045 | | |
| 23,745 | |
Commitments
(note 18)
The
accompanying notes are an integral part of these condensed interim consolidated financial statements.
Approved
by the Board of Directors
/s/
Ronnie Miller |
|
/s/
Dennis Turpin |
Ronnie
Miller, Chair of the Board |
|
Dennis
Turpin, Director |
COSCIENS
Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Condensed
Interim Consolidated Statements of Changes in Shareholders’ Equity
For
the six months ended June 30, 2024, and 2023
(In
thousands of US dollars)
(Unaudited)
| |
| | | |
| | | |
| | | |
| | | |
| | |
| |
Share
capital | | |
Contributed
surplus | | |
Retained
earnings | | |
Accumulated
other comprehensive loss | | |
Total | |
| |
$ | | |
$ | | |
$ | | |
$ | | |
$ | |
Balance
– January 1, 2024 | |
| 13,517 | | |
| 3,874 | | |
| 4,356 | | |
| (712 | ) | |
| 21,035 | |
Net loss | |
| - | | |
| - | | |
| (2,823 | ) | |
| - | | |
| (2,823 | ) |
Other comprehensive loss: | |
| | | |
| | | |
| | | |
| | | |
| | |
Foreign
currency translation adjustments | |
| - | | |
| - | | |
| - | | |
| (506 | ) | |
| (506 | ) |
Comprehensive
loss | |
| | | |
| | | |
| (2,823 | ) | |
| (506 | ) | |
| (3,329 | ) |
Acquisition of Aeterna Zentaris
Inc. (note 3) | |
| 8,485 | | |
| 9 | | |
| - | | |
| - | | |
| 8,494 | |
Share-based
compensation costs | |
| - | | |
| 27 | | |
| - | | |
| - | | |
| 27 | |
Balance
– June 30, 2024 | |
| 22,002 | | |
| 3,910 | | |
| 1,533 | | |
| (1,218 | ) | |
| 26,227 | |
| |
Share
capital | | |
Contributed
surplus | | |
Retained
earnings | | |
Accumulated
other comprehensive loss | | |
Total | |
| |
$ | | |
$ | | |
$ | | |
$ | | |
$ | |
Balance
– January 1, 2023 | |
| 13,496 | | |
| 3,690 | | |
| 7,841 | | |
| (1,204 | ) | |
| 23,823 | |
Balance | |
| 13,496 | | |
| 3,690 | | |
| 7,841 | | |
| (1,204 | ) | |
| 23,823 | |
Net loss | |
| - | | |
| - | | |
| (1,145 | ) | |
| - | | |
| (1,145 | ) |
Other comprehensive loss: | |
| | | |
| | | |
| | | |
| | | |
| | |
Foreign
currency translation adjustments | |
| - | | |
| - | | |
| - | | |
| 546 | | |
| 546 | |
Comprehensive
income | |
| | | |
| | | |
| (1,145 | ) | |
| 546 | | |
| (599 | ) |
Options exercised | |
| 2 | | |
| (1 | ) | |
| - | | |
| - | | |
| 1 | |
Share-based
compensation costs | |
| - | | |
| 143 | | |
| - | | |
| - | | |
| 143 | |
Balance
– June 30, 2023 | |
| 13,498 | | |
| 3,832 | | |
| 6,696 | | |
| (658 | ) | |
| 23,368 | |
Balance | |
| 13,498 | | |
| 3,832 | | |
| 6,696 | | |
| (658 | ) | |
| 23,368 | |
The
accompanying notes are an integral part of these condensed interim consolidated financial statements.
COSCIENS
Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Condensed
Interim Consolidated Statements of Loss and Comprehensive Loss
For
the three and six months ended June 30, 2024, and 2023
(In
thousands of US dollars, except share and per share data)
(Unaudited)
| |
| | | |
| | | |
| | | |
| | |
| |
Three
months ended | | |
Six
months ended | |
| |
June
30, | | |
June
30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| $ | | |
| $ | | |
| $ | | |
| $ | |
Revenues
(note 4) | |
| 2,337 | | |
| 1,392 | | |
| 4,394 | | |
| 3,977 | |
Cost of sales | |
| (1,518 | ) | |
| (595 | ) | |
| (2,671 | ) | |
| (1,992 | ) |
Gross profit | |
| 819 | | |
| 797 | | |
| 1,723 | | |
| 1,985 | |
| |
| | | |
| | | |
| | | |
| | |
Research and development | |
| (1,530 | ) | |
| (691 | ) | |
| (2,592 | ) | |
| (1,115 | ) |
Selling,
general and administrative | |
| (3,044 | ) | |
| (1,220 | ) | |
| (4,710 | ) | |
| (2,352 | ) |
Loss
from operations | |
| (3,755 | ) | |
| (1,114 | ) | |
| (5,579 | ) | |
| (1,482 | ) |
| |
| | | |
| | | |
| | | |
| | |
Gain due to changes in foreign
currency | |
| 17 | | |
| - | | |
| 42 | | |
| - | |
Finance costs | |
| (22 | ) | |
| (24 | ) | |
| (85 | ) | |
| (90 | ) |
Other income | |
| 109 | | |
| 43 | | |
| 158 | | |
| 114 | |
Change
in fair value of warrant and DSU liabilities | |
| 1,755 | | |
| - | | |
| 1,755 | | |
| - | |
Other
income | |
| 1,859 | | |
| 19 | | |
| 1,870 | | |
| 24 | |
| |
| | | |
| | | |
| | | |
| | |
Loss before
income taxes | |
| (1,896 | ) | |
| (1,095 | ) | |
| (3,709 | ) | |
| (1,458 | ) |
| |
| | | |
| | | |
| | | |
| | |
Income
tax recovery | |
| 474 | | |
| 235 | | |
| 886 | | |
| 313 | |
Net loss | |
| (1,422 | ) | |
| (860 | ) | |
| (2,823 | ) | |
| (1,145 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other comprehensive
loss: | |
| | | |
| | | |
| | | |
| | |
Items that may be reclassified
subsequently to profit or loss: | |
| | | |
| | | |
| | | |
| | |
Foreign
currency translation adjustments | |
| (47 | ) | |
| 479 | | |
| (506 | ) | |
| 546 | |
Comprehensive
loss | |
| (1,469 | ) | |
| (381 | ) | |
| (3,329 | ) | |
| (599 | ) |
| |
| | | |
| | | |
| | | |
| | |
Basic
and diluted loss per share (note 16) | |
| (0.64 | ) | |
| (0.47 | ) | |
| (1.39 | ) | |
| (0.62 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted average number of
shares outstanding (basic and diluted) | |
| 2,220,303 | | |
| 1,846,775 | | |
| 2,033,539 | | |
| 1,846,759 | |
The
accompanying notes are an integral part of these condensed interim consolidated financial statements.
COSCIENS
Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Condensed
Interim Consolidated Statements of Cash Flows
For
the three and six months ended June 30, 2024, and 2023
(In
thousands of US dollars)
(Unaudited)
| |
| | | |
| | | |
| | | |
| | |
| |
Three
months ended | | |
Six
months ended | |
| |
June
30, | | |
June
30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| $ | | |
| $ | | |
| $ | | |
| $ | |
Cash flows
from operating activities | |
| | | |
| | | |
| | | |
| | |
Net loss for the
period | |
| (1,422 | ) | |
| (860 | ) | |
| (2,823 | ) | |
| (1,145 | ) |
Items not affecting cash and
cash equivalents: | |
| | | |
| | | |
| | | |
| | |
Depreciation
and amortization | |
| 377 | | |
| 362 | | |
| 736 | | |
| 721 | |
Share-based
compensation costs | |
| 13 | | |
| 43 | | |
| 27 | | |
| 142 | |
Employee
future benefits | |
| 43 | | |
| - | | |
| 43 | | |
| - | |
Change
in fair value of warrant and DSU liabilities | |
| (1,755 | ) | |
| - | | |
| (1,755 | ) | |
| - | |
Other non-cash
items | |
| 11 | | |
| - | | |
| 11 | | |
| - | |
Income
tax recovery | |
| (474 | ) | |
| (235 | ) | |
| (886 | ) | |
| (313 | ) |
Changes
in operating assets and liabilities (note 15) | |
| 1,818 | | |
| (123 | ) | |
| 857 | | |
| (1,047 | ) |
Net
cash used in operating activities | |
| (1,389 | ) | |
| (813 | ) | |
| (3,790 | ) | |
| (1,642 | ) |
| |
| | | |
| | | |
| | | |
| | |
Cash flows
from financing activities | |
| | | |
| | | |
| | | |
| | |
Exercise of stock options | |
| - | | |
| - | | |
| - | | |
| 1 | |
Payments
on lease liabilities | |
| (126 | ) | |
| (70 | ) | |
| (198 | ) | |
| (134 | ) |
Net
cash used in financing activities | |
| (126 | ) | |
| (70 | ) | |
| (198 | ) | |
| (133 | ) |
| |
| | | |
| | | |
| | | |
| | |
Cash flows
from investing activities | |
| | | |
| | | |
| | | |
| | |
Acquisition
of Aeterna Zentaris Inc. (note 3) | |
| 26,037 | | |
| - | | |
| 26,037 | | |
| - | |
Purchase
of property and equipment | |
| (157 | ) | |
| (54 | ) | |
| (721 | ) | |
| (85 | ) |
Net
cash used in investing activities | |
| 25,880 | | |
| (54 | ) | |
| 25,316 | | |
| (85 | ) |
Effect
of exchange rate changes on cash and cash equivalents | |
| (67 | ) | |
| 180 | | |
| (202 | ) | |
| 208 | |
| |
| | | |
| | | |
| | | |
| | |
Net
change in cash and cash equivalents | |
| 24,298 | | |
| (757 | ) | |
| 21,126 | | |
| (1,652 | ) |
Cash
and cash equivalents – Beginning of period | |
| 3,506 | | |
| 9,295 | | |
| 6,678 | | |
| 10,190 | |
Cash
and cash equivalents – End of period | |
| 27,804 | | |
| 8,538 | | |
| 27,804 | | |
| 8,538 | |
The
accompanying notes are an integral part of these condensed interim consolidated financial statements.
COSCIENS
Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
1. Business overview
Summary
of business
COSCIENS
Biopharma Inc. (the “Company”), formerly Aeterna Zentaris Inc., is a specialty biopharmaceutical company developing and commercializing
a diversified portfolio of cosmeceutical, nutraceutical and pharmaceutical products. The Company’s patented technologies include
Pressurized Gas eXpanded (PGX) technology that generates high-value yields of active ingredients from natural plant resources for use
in novel cosmeceutical, nutraceutical and therapeutics products. The Company’s two value-driving active ingredient products, oat
beta glucan and avenanthramides, are found in many household name cosmetic and personal care brands. These products are manufactured
from the Company’s proprietary oat extraction manufacturing technology and are known for their health benefits.
The
Company’s lead pharmaceutical product, macimorelin (Macrilen; Ghryvelin), is the first and only U.S. FDA and European Commission
approved oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD). The Company is leveraging the clinical success
and safety profile of macimorelin to develop it for the diagnosis of childhood-onset growth hormone deficiency (CGHD).
The
Company is also dedicated to the development of its therapeutic assets and has established a pre-clinical development pipeline to potentially
address unmet medical needs across a number of indications, including treatment of inflammation-based diseases, idiopathic pulmonary
fibrosis (IPF), neuromyelitis optica spectrum disorder (NMOSD), Parkinson’s disease (PD), hypoparathyroidism and amyotrophic lateral
sclerosis (ALS; Lou Gehrig’s disease).
Transaction
On
December 14, 2023, Aeterna Zentaris Inc. (“Aeterna”) and Ceapro Inc. (“Ceapro”) entered into a binding arrangement
agreement pursuant to which Aeterna would acquire all of the issued and outstanding common shares of Ceapro (the “Transaction”)
by way of a plan of arrangement pursuant to which, at closing, each outstanding Ceapro common share would be exchanged for 0.02360 of
a Aeterna common share (the “Plan of Arrangement”). Additionally, as part of the Transaction, Aeterna would issue to its
shareholders immediately prior to the closing of the Transaction, 0.47698 of a share purchase warrant (“New Warrant”) for
each Aeterna common share or warrant held. On March 12, 2024, the shareholders of both Ceapro and Aeterna approved the Plan of Arrangement
at their respective special meetings. On March 28, 2024, the Court of Kings Bench of Alberta approved the Plan of Arrangement. The Transaction
was consummated on June 3, 2024.
Following
the closing of the Transaction, former shareholders of Ceapro owned approximately 50% of the Aeterna common shares on a fully diluted
basis and former shareholders of Aeterna owned approximately 50% of the Aeterna common shares on a fully diluted basis. For financial
reporting and accounting purposes, Ceapro is the acquirer of Aeterna in the Transaction. The consolidated financial statements of COSCIENS
Biopharma Inc. as of June 30, 2024 and December 31, 2023 and for the three and six months ended June 30, 2024 and 2023 reflect the results
of operations and financial position of Ceapro for the periods presented and includes 28 days of the results of operations of Aeterna
as of June 30, 2024 and for three and six months ended June 30, 2024 subsequent to the Transaction, which was completed on June 3, 2024.
Refer to Note 3 for additional information.
The
accompanying consolidated financial statements include the accounts of COSCIENS Biopharma Inc., an entity incorporated under the Canada
Business Corporations Act, and its wholly owned subsidiaries (the “Group”). COSCIENS Biopharma Inc. is the ultimate parent
company of the Group. The Company currently has six wholly-owned direct and indirect subsidiaries, Ceapro Inc. and its wholly-owned subsidiaries
Ceapro (P.E.I.) and JuventeDC Inc., based in Canada, Aeterna Zentaris GmbH (“AEZS Germany”) and its wholly-owned
subsidiary Zentaris IVF GmbH, based in Frankfurt, Germany, and Aeterna Zentaris, Inc., an entity incorporated in the state of Delaware
and with offices in Summerville, South Carolina, in the US.
COSCIENS
Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
The
registered office of the Company is located at 222 Bay Street, Suite 3000, P.O. Box 53, Toronto, Ontario M5K 1E7, Canada.
The
Company’s common shares are listed on both the Toronto Stock Exchange under the symbol CSCI (previously AEZS) and on the NASDAQ
Capital Market under the symbol CSCI (previously AEZS).
2. Basis of presentation
These
unaudited condensed interim consolidated financial statements have been prepared in accordance with IAS 34, Interim Financial Reporting
as issued by the International Accounting Standards Board.
The
unaudited condensed interim consolidated financial statements do not include all the notes normally included in annual consolidated financial
statements. The unaudited condensed interim consolidated financial statements reflect all normal and reoccurring adjustments that are,
in the opinion of management, necessary for a fair presentation of the results for the interim periods presented. Accordingly, these
unaudited condensed interim consolidated financial statements should be read in conjunction with the Ceapro’s annual consolidated
financial statements as of and for the year ended December 31, 2023.
The
accounting policies used in these condensed interim consolidated financial statements are consistent with those presented in Ceapro’s
annual consolidated financial statements, except for the accounting policies as described below:
Business
combinations
Business
combinations are accounted for using the acquisition method as at the acquisition date when control is transferred. The consideration
transferred for the acquisition of a business is the fair value of the assets transferred, and any liability and equity interests issued
by the Company to the former owners of the acquired business on the acquisition date. Identifiable assets acquired and liabilities assumed
in a business combination are generally measured initially at their fair values at the acquisition date. Acquisition-related costs other
than those associated with the issue of debt or equity securities, and other direct costs of a business combination are not considered
part of the business acquisition transaction and are expensed as incurred.
Foreign
currency
Effective
June 30, 2024, Ceapro has changed its reporting currency from Canadian dollars to U.S. dollars. This change in reporting currency has
been applied retrospectively such that all amounts in the consolidated financial statements of the Company and the accompanying notes
thereto are expressed in U.S. dollars. References to “$” are U.S. dollars and references to “CA $” are to Canadian
dollars. For comparative purposes, historical consolidated financial statements of Ceapro were recast in U.S. dollars by translating
assets and liabilities at the closing exchange rate in effect at the end of the respective period, revenues, expenses and cash flows
at the average exchange rate in effect for the respective period and equity transactions at historical exchange rates. Translation gains
and losses are included in the cumulative foreign currency translation adjustment, which is reported as a component of shareholders’
equity under accumulated other comprehensive loss.
COSCIENS
Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
Post-employment
benefits
The
Company has partially funded and unfunded defined benefit multi-employer pension plans, namely the DUPK pension plan and the RUK 1990
and 2006 pension plans, (the “Pension Benefit Plans”) and unfunded post-employment benefit plans in Germany. Provisions for
pension obligations are established for benefits payable in the form of retirement, disability and surviving dependent pensions. The
Company also provides defined contribution plans to some of its employees.
For
defined benefit pension plans and other post-employment benefits, net periodic pension expense is actuarially determined on a quarterly
basis using the projected unit credit method. The cost of pension and other benefits earned by employees is determined by applying certain
assumptions, including discount rates, rate of pension benefit increases, the projected age of employees upon retirement and the expected
rate of future compensation.
The
employee future benefits liability is recognized at its present value, which is determined by discounting the estimated future cash outflows
using interest rates of high-quality corporate bonds that are denominated in the currency in which the benefits will be paid and that
have terms to maturity approximating the terms of the related future benefit liability. Actuarial gains and losses that arise in calculating
the present value of the defined benefit obligation are recognized in other comprehensive loss, net of tax, and simultaneously reclassified
in the deficit in the consolidated statement of financial position in the year in which the actuarial gains and losses arise and without
recycling to the consolidated statement of loss and comprehensive loss in subsequent periods.
Revenue
The
Company generates revenue from supply agreements and licensing agreements with customers for the sale of certain finished goods, semi-finished
goods and active pharmaceutical ingredients. The license is generally combined with other promises to supply goods to the customer, and
revenue from the combined performance obligation is satisfied at a point in time, which occurs upon shipment. The transaction price for
the combined performance obligation includes the license non-refundable non-creditable upfront payment, regulatory milestones, royalties
and the selling price of each good supplied. Milestone payments, which are oftentimes payable upon the successful achievement of development
or regulatory events, and royalties are included in the transaction price using the most likely amount method only if the milestones
are considered probable of being reached and the Company concludes it is highly probable that a significant revenue reversal will not
occur. Milestone payments and royalties that are not within the control of the Company or the licensee, such as regulatory approvals,
are generally not considered probable of being achieved until those approvals or subsequent sales are received. The Company allocates
the transaction price to the projected units that the Company expects to supply pursuant to the contract, estimated based on current
projections and anticipated market demand.
Intangible
assets
Intangible
assets, consisting of patents, that are acquired by the Company and have finite useful lives are measured at cost less accumulated amortization
and any accumulated impairment losses. Patents are amortized on their respective remaining patent life and are expiring between 2027
and 2041.
Warrant
liabilities
Warrant
liabilities are derivative financial instruments. They are initially measured at fair value. Subsequent to initial recognition, they
are measured at fair value, and changes therein are recognised in profit or loss.
COSCIENS
Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
Reclassifications
Certain
prior period amounts have been reclassified to conform to current period presentation. In the consolidated statement of financial position,
trade receivables of $126 and other receivable of $164 were classified to trade and other receivables. In the consolidated statements
of loss for the six months ended June 30, 2023, the general and administration expenses of $2,336 (for the three months ended June 30,
2023 - $1,210) and the sales and marketing expenses of $16 (for the three months ended June 30, 2023 - $10) were reclassified within
Selling, general and administrative expenses.
New
standards and amendments
Several
amendments apply for the first time for reporting periods beginning after January 1, 2024, but do not have an impact on the interim condensed
consolidated financial statements of the Company. The IASB has published several new, but not yet effective, standards, amendments to
existing standards, and interpretations. None of these standards, amendments to existing standards, or interpretations have been early
adopted by the Company, and management anticipates that all relevant pronouncements will be adopted for the first period beginning on
or after the effective date of the pronouncement. No pronouncements have been disclosed as they are not expected to have a material impact
on the Company’s condensed interim consolidated financial statements.
Critical
accounting estimates and judgements
The
preparation of condensed interim consolidated financial statements in accordance with IFRS requires management to make judgements, estimates
and assumptions about the future that affect the reported amounts of the Company’s assets, liabilities, revenues, expenses and
related disclosures. Judgements, estimates and assumptions are based on historical experience, expectations, current trends and other
factors that management believes to be relevant at the time at which the Company’s condensed interim consolidated financial statements
are prepared.
Management
reviews, on a regular basis, the Company’s accounting policies, assumptions, estimates and judgements in order to ensure that the
condensed interim consolidated financial statements are presented fairly and in accordance with IFRS applicable to interim financial
statements. Revisions to estimates are recognized prospectively. Critical accounting estimates and assumptions, as well as critical judgements
used in applying accounting policies in the preparation of the Company’s condensed interim consolidated financial statements, were
the same as those applied to Ceapro’s annual consolidated financial statements as of and for the year ended December 31, 2023,
except for as described below:
|
● |
Measurement
of defined benefit obligations: key actuarial assumptions (note 10); and |
|
● |
Business
acquisition: identification of the acquirer, determination of the fair value of the consideration transferred and fair value of some
of the assets acquired and liabilities assumed (note 3). |
3. Acquisition of Aeterna Zentaris Inc.
As
discussed in Note 1, Business Overview, as a result of the Transaction, Ceapro acquired control of Aeterna Zentaris Inc. on June 3, 2024.
Aeterna is a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests. Aeterna’s lead
product, Macrilen® (macimorelin), is the first and only U.S. FDA and EMA approved oral test indicated for the diagnosis of patients
with adult growth hormone deficiency (“AGHD”). Macimorelin is currently marketed under the tradename Ghryvelin™ in
the European Economic Area and the United Kingdom through an exclusive licensing agreement with Pharmanovia. Aeterna is actively pursuing
business development opportunities for the commercialization of macimorelin in North America, Asia and the rest of the world. Aeterna
is also dedicated to the development of therapeutic assets and has taken steps to establish a pre-clinical pipeline to potentially address
unmet medical needs across several indications with a focus on rare or orphan indications.
COSCIENS
Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
The
Transaction was accounted for as a reverse acquisition under the acquisition method of accounting for business combinations. Ceapro was
considered to be the accounting acquirer, and Aeterna was considered the legal acquirer. The amounts recorded for certain assets and
liabilities are preliminary in nature and are subject to adjustment as additional information is obtained about the facts and circumstances
that existed as of the acquisition date. The final determination of the fair values of certain assets and liabilities will be completed
within the measurement period of up to one year from the acquisition date. Under the acquisition method of accounting, total consideration
exchanged and allocation of the purchase price to the fair values of assets acquired and liabilities assumed in the Transaction were
as follows:
Schedule
of purchase price to the fair values of assets acquired and liabilities assumed
Preliminary
Purchase Price Allocation
| |
| | | |
| | |
| |
Number | | |
Amount | |
| |
# | | |
$ | |
Purchase
price | |
| | | |
| | |
Shares deemed
issued to Aeterna shareholders(1) | |
| | |
| 8,485 | |
Warrants issued to Aeterna
shareholders(2) | |
| 633,543 | | |
| 4,422 | |
Replacement share-based
payment awards: | |
| | | |
| | |
Equity-settled options(3) | |
| 12,949 | | |
| 9 | |
Cash-settled DSUs(3) | |
| 49,230 | | |
| 344 | |
Warrants
deemed issued(4) | |
| 114,405 | | |
| 2 | |
| |
| 2,024,094 | | |
| 13,262 | |
| |
| | | |
| | |
Recognized
amounts of identifiable assets acquired and liabilities assumed | |
| | | |
| | |
Cash and cash equivalents | |
| | | |
| 26,037 | |
Trade and other receivables | |
| | | |
| 142 | |
Inventories | |
| | | |
| 64 | |
Income tax receivables | |
| | | |
| 119 | |
Prepaid expenses and deposits | |
| | | |
| 971 | |
Restricted cash equivalents | |
| | | |
| 328 | |
Property and equipment | |
| | | |
| 235 | |
Intangible assets(5) | |
| | | |
| 3,352 | |
Accounts payable and accrued
liabilities | |
| | | |
| (4,357 | ) |
Provisions | |
| | | |
| (424 | ) |
Income tax payable | |
| | | |
| (109 | ) |
Deferred revenues | |
| | | |
| (1,731 | ) |
Lease liabilities | |
| | | |
| (201 | ) |
Employee future benefits | |
| | | |
| (11,164 | ) |
| |
| | | |
| | |
Total
provisional identifiable net assets (liabilities) | |
| | | |
| 13,262 | |
COSCIENS
Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
The
fair value of the replacement awards is $356, after taking into account an estimated forfeiture rate of nil. The consideration for the
business combination includes $9 for equity-settled options and $344 for cash-settled DSUs transferred to employees of Aeterna when the
acquiree’s awards were substituted by the replacement awards, which relates to past service. The balance of $3 will be recognized
as post-acquisition compensation cost.
The
fair value at acquisition date was estimated using a Black-Scholes option pricing model, considering the terms and conditions upon which
the options were granted, using the following assumptions:
Schedule of fair value at acquisition date was estimated using a Black-Scholes option
| |
Options | |
Expected dividend
yield | |
$ | 0.0 | |
Weighted average expected volatility | |
| 65 | % |
Weighted average risk-free rate | |
| 4.01 | % |
Weighted average expected life (years) | |
| 2.87 | |
Share price | |
$ | 6.99 | |
Weighted average exercise price | |
$ | 50.15 | |
Weighted average fair value | |
$ | 0.90 | |
The
expected volatility of these options was determined using historical volatility rates and the expected life was determined using the
weighted average life of past options issued.
The
fair value of the replacement DSUs of $6.99 per DSU was based on the listed share price of Ceapro as at June 3, 2024 (CA$0.225), after
giving effect to the exchange of each outstanding Ceapro common share for 0.02360 of a Aeterna common share and the foreign currency
exchange rate.
|
(4) |
The fair value of the 114,405
warrants deemed issued to Aeterna warrant holders was estimated using a Black-Scholes option pricing model, considering the terms and
conditions upon which the warrants were issued, using the following assumptions: |
Schedule of fair value at acquisition date was estimated using a Black-Scholes option
| |
Warrants | |
Expected dividend
yield | |
$ | 0.00 | |
Weighted average expected volatility | |
| 65 | % |
Weighted average risk-free rate | |
| 4.47 | % |
Weighted average expected life (years) | |
| 1.19 | |
Share price | |
$ | 6.99 | |
Weighted average exercise price | |
$ | 87.04 | |
Weighted average fair value | |
$ | 0.02 | |
|
(5) |
The identifiable intangible
assets consist of patents expiring between 2027 and 2041 which will be amortized on their respective remaining patent life. To estimate
the fair value of the intangible assets, management uses the royalty relief method to value patents using discounted cash flow models.
Management developed assumptions related to revenue and EBITDA margin forecasts, attrition rates, royalty rates and discount rates. |
For
the period subsequent to the Transaction, Aeterna contributed revenue of $3 and net loss of $214 to the Company’s results. If the
acquisition had occurred on January 1, 2024, management estimates that revenue would have been $4,399 and consolidated net loss for the
year would have been $12,035. In determining these amounts, management has assumed that the fair value adjustments that arose on the
date of acquisition would have been the same if the acquisition had occurred on January 1, 2024.
COSCIENS
Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
The
Company incurred acquisition-related costs of $4,081 on legal fees and due diligence costs. These costs have been included in Selling,
general and administrative expenses as incurred.
4. Revenue
The
Company derives revenue from the transfer of goods at a point in time in the following categories:
Summary
of revenue from transfer of goods and services
| |
| | | |
| | | |
| | | |
| | |
| |
Three
months ended | | |
Six
months ended | |
| |
June
30, | | |
June
30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| $ | | |
| $ | | |
| $ | | |
| $ | |
Active ingredients | |
| 2,334 | | |
| 1,392 | | |
| 4,391 | | |
| 3,977 | |
Pharmaceutical | |
| 3 | | |
| - | | |
| 3 | | |
| - | |
Total | |
| 2,337 | | |
| 1,392 | | |
| 4,394 | | |
| 3,977 | |
Deferred
revenue
The
deferred revenue balance primarily relates to the advance consideration received in the form of non-refundable non-creditable upfront
payment and milestone payments relating to list price approvals of Ghryvelin™ in the United Kingdom, Spain and Germany as per an
exclusive licensing agreement for the commercialization of macimorelin (the “Licensed Product”) in the European Economic
Area and the United Kingdom and an exclusive supply agreement for a period of ten years, subject to renewal, to supply such Licensed
Product.
Revenue
for this contract will be recognized based on units of Licensed Product supplied. The total units that the Company expects to supply
pursuant to the Pharmanovia Agreement is an estimate, based on current projections and anticipated market demand, and therefore will
be a significant judgment that will be relied upon when using the outputs method to recognize revenue. The Company expects to recognize
the balance of the deferred revenue over the remaining period of eight years, subject to extension based on the outcome of the ongoing
clinical development related to the Pediatric Indication and related patent application initiatives. For the three months and six months
ended June 30, 2024, the Company recognized $nil and $nil respectively as revenue from the deferred revenue balance originating from
the acquisition of Aeterna Zentaris Inc. (note 3).
Liabilities
related to contracts with customers
The
following table provides a summary of deferred revenue balances:
Summary
of deferred revenue
| |
| Current | | |
| Non-current | | |
| Total | |
| |
June
30, 2024 | |
| |
Current | | |
Non-current | | |
Total | |
| |
| $ | | |
| $
| | |
| $
| |
Pharmanovia | |
| 97 | | |
| 1,484 | | |
| 1,581 | |
NK
Meditech | |
| - | | |
| 129 | | |
| 129 | |
Contract liabilities | |
| 97 | | |
| 1,613 | | |
| 1,710 | |
COSCIENS
Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
5. Inventories
The
Company had the following inventories at the end of each reporting period:
Schedule
of inventories
| |
| | | |
| | |
| |
June
30, | | |
December
31, | |
| |
2024 | | |
2023 | |
| |
| $ | | |
| $ | |
Raw materials | |
| 767 | | |
| 889 | |
Work in progress | |
| 2,080 | | |
| 2,576 | |
Finished
goods | |
| 208 | | |
| 544 | |
Inventories | |
| 3,055 | | |
| 4,009 | |
Inventories
expensed to cost of goods sold during the three-month period ended June 30, 2024, are $1,398 (June 30, 2023 - $595) and the six-month
period ended June 30, 2024, are $2,467 (June 30, 2023 - $1,992).
6. Prepaid expenses and other assets
The
Company had the following prepaid expenses at the end of each reporting period:
Summary of prepaid expenses and other current assets
| |
| | | |
| | |
| |
June
30, | | |
December
31, | |
| |
2024 | | |
2023 | |
| |
| $ | | |
| $ | |
Prepaid insurance | |
| 4 | | |
| 81 | |
Prepaid research and development | |
| 681 | | |
| 97 | |
Other | |
| 309 | | |
| 112 | |
Total | |
| 994 | | |
| 290 | |
COSCIENS
Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
7. Property and equipment
Components
of the Company’s property and equipment are summarized below.
Schedule
of property and equipment
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| |
Cost | |
| |
Equipment
Not Available for Use | | |
Equipment | | |
Office
and Computer Equipment | | |
Buildings | | |
Leasehold
Improvements | | |
Total | |
| |
| $ | | |
| $ | | |
| $ | | |
| $ | | |
| $ | | |
| $ | |
At January 1,
2023 | |
| 1,462 | | |
| 9,223 | | |
| 681 | | |
| 2,730 | | |
| 6,442 | | |
| 20,538 | |
Additions | |
| 683 | | |
| 68 | | |
| 20 | | |
| - | | |
| 86 | | |
| 857 | |
Disposals | |
| - | | |
| (438 | ) | |
| - | | |
| - | | |
| - | | |
| (438 | ) |
Impact
of foreign exchange rate changes | |
| 54 | | |
| 206 | | |
| 16 | | |
| 64 | | |
| 152 | | |
| 492 | |
At December 31, 2023 | |
| 2,199 | | |
| 9,059 | | |
| 717 | | |
| 2,794 | | |
| 6,680 | | |
| 21,449 | |
Property plant and equipment | |
| 2,199 | | |
| 9,059 | | |
| 717 | | |
| 2,794 | | |
| 6,680 | | |
| 21,449 | |
Acquisition of Aeterna (note
3) | |
| - | | |
| 124 | | |
| 23 | | |
| 88 | | |
| - | | |
| 235 | |
Additions | |
| 700 | | |
| 6 | | |
| 3 | | |
| - | | |
| 12 | | |
| 721 | |
Impact
of foreign exchange rate changes | |
| (77 | ) | |
| (294 | ) | |
| (26 | ) | |
| (99 | ) | |
| (217 | ) | |
| (713 | ) |
At
June 30, 2024 | |
| 2,822 | | |
| 8,895 | | |
| 717 | | |
| 2,783 | | |
| 6,475 | | |
| 21,692 | |
Property plant and equipment | |
| 2,822 | | |
| 8,895 | | |
| 717 | | |
| 2,783 | | |
| 6,475 | | |
| 21,692 | |
| |
Accumulated
Depreciation | |
| |
Equipment
Not Available for Use | | |
Equipment | | |
Office
and Computer Equipment | | |
Buildings | | |
Leasehold
Improvements | | |
Total | |
| |
| $ | | |
| $ | | |
| $ | | |
| $ | | |
| $ | | |
| $ | |
At January 1,
2023 | |
| - | | |
| 4,842 | | |
| 565 | | |
| 997 | | |
| 2,180 | | |
| 8,584 | |
Amortization | |
| - | | |
| 630 | | |
| 34 | | |
| 287 | | |
| 490 | | |
| 1,441 | |
Disposals | |
| - | | |
| (438 | ) | |
| - | | |
| - | | |
| - | | |
| (438 | ) |
Impact
of foreign exchange rate changes | |
| - | | |
| 114 | | |
| 14 | | |
| 29 | | |
| 60 | | |
| 217 | |
At December 31, 2023 | |
| - | | |
| 5,148 | | |
| 613 | | |
| 1,313 | | |
| 2,730 | | |
| 9,804 | |
Property plant and equipment | |
| - | | |
| 5,148 | | |
| 613 | | |
| 1,313 | | |
| 2,730 | | |
| 9,804 | |
Amortization | |
| - | | |
| 307 | | |
| 14 | | |
| 142 | | |
| 249 | | |
| 712 | |
Impact
of foreign exchange rate changes | |
| - | | |
| (167 | ) | |
| (22 | ) | |
| (44 | ) | |
| (90 | ) | |
| (323 | ) |
At
June 30, 2024 | |
| - | | |
| 5,288 | | |
| 605 | | |
| 1,411 | | |
| 2,889 | | |
| 10,193 | |
Property plant and equipment | |
| - | | |
| 5,288 | | |
| 605 | | |
| 1,411 | | |
| 2,889 | | |
| 10,193 | |
| |
Carrying
amount | |
| |
Equipment
Not Available for Use | | |
Equipment | | |
Office
and Computer Equipment | | |
Buildings | | |
Leasehold
Improvements | | |
Total | |
| |
| $ | | |
| $ | | |
| $ | | |
| $ | | |
| $ | | |
| $ | |
At December
31, 2023 | |
| 2,199 | | |
| 3,911 | | |
| 104 | | |
| 1,481 | | |
| 3,950 | | |
| 11,645 | |
Property plant and equipment, Beginning | |
| 2,199 | | |
| 3,911 | | |
| 104 | | |
| 1,481 | | |
| 3,950 | | |
| 11,645 | |
At
June 30, 2024 | |
| 2,822 | | |
| 3,607 | | |
| 112 | | |
| 1,372 | | |
| 3,586 | | |
| 11,499 | |
Property plant and equipment, Ending | |
| 2,822 | | |
| 3,607 | | |
| 112 | | |
| 1,372 | | |
| 3,586 | | |
| 11,499 | |
COSCIENS
Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
Depreciation
expense is allocated to the following expense categories:
Schedule of
depreciation expenses
| |
| | | |
| | | |
| | | |
| | |
| |
Cost
of goods sold | | |
Selling,
general and administrative | | |
Research
and development | | |
Total | |
| |
| $ | | |
| $ | | |
| $ | | |
| $ | |
Six Months
Ended June 30, 2023 | |
| 579 | | |
| 142 | | |
| - | | |
| 721 | |
Six
Months Ended June 30, 2024 | |
| 514 | | |
| 157 | | |
| 41 | | |
| 712 | |
Included
right-of-use in the net carrying amount of property and equipment at June 30, 2024, are assets relating to buildings, in the amount of
$1,372 (December 31, 2023 - $1,481).
Included
in the carrying amount of leasehold improvements is $800 (December 31, 2023 - $800) and included in the carrying amount of equipment
not available for use is $2,822 (December 31, 2023 - $2,199) which represent the accumulated expenditures incurred on the purchase of
an ethanol recovery system, equipment purchased for technology scale-up, other equipment, and the engineering design for the related
construction and installation of the ethanol recovery system. Construction and installation activities related to technology scale-up
have progressed since year-end. However, as the activities had not yet been finalized, depreciation on these balances has not commenced.
The
Company has entered into a purchase commitment with a European specialized engineering firm for the supply of engineering, services and
equipment related to the construction of a PGX-100 pilot plant for $947 (€1,015). Payments made toward the purchase are included
in the carrying amount of equipment not available for use. As of June 30, 2024, the remaining purchase commitment is $678 (€727)
and is expected to be completed in 2024.
COSCIENS
Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
8. Intangible assets
Changes
in the carrying value of the Company’s identifiable intangible assets are summarized below.
Schedule
of Intangible Assets
| |
Cost | | |
Accumulated
amortization | | |
Carrying
value | |
| |
As
at June 30, 2024 | |
| |
Cost | | |
Accumulated
amortization | | |
Carrying
value | |
| |
| $ | | |
| | | |
| $ | |
At January 1,
2024 | |
| 34 | | |
| (27 | ) | |
| 7 | |
Acquisition of Aeterna (note
3) | |
| 3,352 | | |
| - | | |
| 3,352 | |
Amortization | |
| - | | |
| (24 | ) | |
| (24 | ) |
Impact
of foreign exchange rate changes | |
| 1 | | |
| (1 | ) | |
| - | |
At
June 30, 2024 | |
| 3,387 | | |
| (52 | ) | |
| 3,335 | |
| |
As
at December 31, 2023 | |
| |
Cost | | |
Accumulated
amortization | | |
Carrying
value | |
| |
| $ | | |
| | | |
| $ | |
At January 1, 2023 | |
| 33 | | |
| (24 | ) | |
| 9 | |
Acquisition of Aeterna (note
3) | |
| - | | |
| - | | |
| - | |
Amortization | |
| - | | |
| (3 | ) | |
| (3 | ) |
Impact
of foreign exchange rate changes | |
| 1 | | |
| - | | |
| 1 | |
At December 31, 2023 | |
| 34 | | |
| (27 | ) | |
| 7 | |
9. Accounts payable
The
Company had the following accounts payable and accrued expenses at the end of each reporting period:
Summary
of detailed information about accounts payable and accrued expenses
| |
June
30, | | |
December
31, | |
| |
2024 | | |
2023 | |
| |
| $ | | |
| $ | |
Trade accounts
payable | |
| 3,585 | | |
| 281 | |
Accrued research and development
costs | |
| 510 | | |
| - | |
Accrued employee benefits | |
| 472 | | |
| 130 | |
Payroll tax and other statutory
liabilities | |
| 7 | | |
| - | |
Other
accrued liabilities | |
| 1,267 | | |
| 601 | |
Accounts
Payables and accrued liabilities | |
| 5,841 | | |
| 1,012 | |
COSCIENS
Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
10. Employee future benefits
The
change in the Company’s employee future benefit obligations is summarized as follows:
Summary
of net employee future benefit liability asset
| |
| $ | | |
| $ | | |
| $ | |
| |
Six
months ended June
30, 2024 | |
| |
Pension | | |
Other | | |
| |
| |
benefit
plans | | |
benefit
plans | | |
Total | |
| |
| $ | | |
| $ | | |
| $ | |
Change
in plan liabilities | |
| | | |
| | | |
| | |
Balances – Beginning of the period | |
| - | | |
| - | | |
| - | |
Acquisition of
Aeterna (note 3) | |
| 22,036 | | |
| 100 | | |
| 22,136 | |
Current service cost | |
| 10 | | |
| 1 | | |
| 11 | |
Interest cost | |
| 66 | | |
| - | | |
| 66 | |
Actuarial gain from changes
in financial assumptions | |
| - | | |
| - | | |
| - | |
Benefits paid | |
| (61 | ) | |
| - | | |
| (61 | ) |
Impact
of foreign exchange rate changes | |
| (271 | ) | |
| (2 | ) | |
| (273 | ) |
Balances
– End of the period | |
| 21,780 | | |
| 99 | | |
| 21,879 | |
| |
| | | |
| | | |
| | |
Change
in plan assets | |
| | | |
| | | |
| | |
Balances – Beginning of the period | |
| - | | |
| - | | |
| - | |
Acquisition of Aeterna Zentaris
Inc. (note 3) | |
| 10,972 | | |
| - | | |
| 10,972 | |
Interest income from plan
assets | |
| 33 | | |
| - | | |
| 33 | |
Employer contributions | |
| 3 | | |
| - | | |
| 3 | |
Employee contributions | |
| 1 | | |
| - | | |
| 1 | |
Benefits paid | |
| (21 | ) | |
| - | | |
| (21 | ) |
Impact
of foreign exchange rate changes | |
| (136 | ) | |
| - | | |
| (136 | ) |
Balances
– End of the period | |
| 10,852 | | |
| - | | |
| 10,852 | |
| |
| | | |
| | | |
| | |
Net liability of the unfunded
plans | |
| 10,717 | | |
| 99 | | |
| 10,816 | |
Net
liability of the funded plans | |
| 211 | | |
| - | | |
| 211 | |
Net
amount recognized as Employee future benefits | |
| 10,928 | | |
| 99 | | |
| 11,027 | |
| |
| | | |
| | | |
| | |
Amounts recognized: | |
| | | |
| | | |
| | |
In net loss | |
| 42 | | |
| 1 | | |
| 43 | |
Actuarial gain on defined
benefit plans in other comprehensive loss | |
| - | | |
| - | | |
| - | |
The
calculation of the employee future benefit obligation is sensitive to the discount rate assumption and other assumptions such as the
rate of the pension benefit increase. There was no change in the discount rate of 3.70% used as of June 3, 2024 to the rate used as of
June 30, 2024, resulting in nil movement in the actuarial gain on defined benefit plan during the six months ended June 30, 2024.
COSCIENS
Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
11. Warrants
Warrant
activity for the six months ended June 30, 2024, was as follows:
Summary
of warrants activity reclassified equity
| |
Warrants | | |
Weighted
average exercise price | | |
Amount | |
| |
| # | | |
| $ | | |
| $ | |
Balance – December
31, 2023 | |
| - | | |
| - | | |
| - | |
Warrants
either issued or assumed as part of the acquisition of Aeterna (note 3) | |
| 747,948 | | |
| 13.32 | | |
| 4,424 | |
Change
in fair value of warrants | |
| - | | |
| - | | |
| (1,628 | ) |
Balance
– June 30, 2024 | |
| 747,948 | | |
| 13.32 | | |
| 2,796 | |
The
method and inputs used in estimating the fair value of warrants on the acquisition date are described in Note 3. The fair values of warrants
as at June 30, 2024 are estimated using the Black-Scholes option pricing model. The weighted average assumptions used in the Black-Scholes
valuation model for the period presented were as follows:
Summary
of fair values of warrants assumptions
| |
| June
30, 2024 | |
Expected dividend
yield | |
$ | 0.00 | |
Expected volatility | |
| 65.00 | % |
Risk-free annual interest
rate | |
| 4.47 | % |
Expected life (years) | |
| 2.65 | |
Weighted average share price | |
$ | 6.99 | |
Weighted average exercise price | |
$ | 13.32 | |
At
June 30, 2024, the following warrants were outstanding:
Schedule
of warrants outstanding
Issuance
date | |
Number | | |
Weighted
average remaining contractual life | | |
Weighted
average exercise price | |
| |
| # | | |
| years | | |
| $ | |
September 2019 | |
| 13,249 | | |
| 0.24 | | |
| 165.00 | |
February 2020 | |
| 11,129 | | |
| 1.14 | | |
| 129.12 | |
July 2020 | |
| 56,210 | | |
| 1.01 | | |
| 45.00 | |
August 2020 | |
| 17,310 | | |
| 1.60 | | |
| 47.00 | |
February 2021 | |
| 16,507 | | |
| 1.64 | | |
| 181.25 | |
June 2024 | |
| 633,543 | | |
| 2.93 | | |
| 0.01 | |
Balance
– June 30, 2024 | |
| 747,948 | | |
| 2.65 | | |
| 13.32 | |
COSCIENS
Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
12. Deferred share units
The
compensation expense for the six months ended June 30, 2024, was a gain of $127 (2023 - nil) and is presented in selling, general and
administrative expenses. DSU activity for the six months ended June 30, 2024, was as follows:
Summary
of number and weighted average exercise prices of deferred shares units
| |
Units | | |
Amount | |
| |
# | | |
$ | |
Balance – January 1,
2024 | |
| - | | |
| - | |
Granted –
Replacement awards (note 3) | |
| 49,230 | | |
| 344 | |
Change
in fair value of DSUs | |
| - | | |
| (127 | ) |
Balance
– June 30, 2024 | |
| 49,230 | | |
| 217 | |
13. Shareholders’ equity
Share
capital
The
Company has authorized an unlimited number of common shares (being voting and participating shares) with no par value, as well as an
unlimited number of preferred, first and second ranking shares, issuable in series, with rights and privileges specific to each class,
with no par value.
Summary of share capital
| |
Common
shares | | |
Amount | |
| |
# | | |
$ | |
Balance –
December 31, 2023 | |
| 1,847,593 | | |
| 13,517 | |
Deemed
issuance of shares to Aeterna shareholders (note 3) | |
| 1,213,967 | | |
| 8,485 | |
Balance
– June 30, 2024 | |
| 3,061,560 | | |
| 22,002 | |
As
discussed in Note 1, Business Overview, on June 3, 2024, each outstanding Ceapro common share was exchanged for 0.02360 of an Aeterna
common share. Accordingly, all common shares, stock options and per share amounts in these interim
condensed consolidated financial statements have been retroactively adjusted for all periods presented to give effect to the share exchange.
Share-based
compensation
The
Company grants stock options to eligible employees, directors, officers, and consultants under stock option plans. In accordance with
the terms of the Plan of Arrangement, the 12,949 share-based payment awards held by employees of Aeterna prior to the transaction date
of June 3, 2024 are deemed to be replacement awards issued with no modifications. Furthermore, in the six months ended June 30, 2024,
the Company granted nil (2023 – 21,004) new stock options. The stock options have a term of seven years and will vest over a period
of three years. The fair value at grant date is estimated using a Black-Scholes option pricing model, considering the terms and conditions
upon which the options were granted, using the following assumptions:
Summary
of assumptions to determine share-based compensation options granted
| |
June
30, 2023 | |
Expected dividend
yield | |
$ | 0.00 | |
Expected volatility | |
| 65.00 | % |
Risk-free annual interest
rate | |
| 3.21 | % |
Expected life (years) | |
| 5.0 | |
Share price | |
$ | 25.85 | |
Exercise price | |
$ | 25.85 | |
Grant date fair value | |
$ | 14.83 | |
COSCIENS
Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
The
expected volatility of these stock options was determined using historical volatility rates and the expected life was determined using
the weighted average life of past options issued.
The
compensation expense for the three months ended June 30, 2024, was $13 (2023 – $43) and for the six months ended June 30, 2024,
was $27 (2023 – $142) recognized over the vesting period. Option activity for the six months ended June 30, 2024, and 2023, was
as follows:
Summary
of number and weighted average exercise prices of deferred shares units
| |
Stock
options | | |
Weighted
average exercise price | |
| |
# | | |
$ | |
Balance –
January 1, 2024 | |
| 74,371 | | |
| 20.74 | |
Granted - Replacement options
(note 3) | |
| 12,949 | | |
| 50.65 | |
Cancelled
/ Forfeited | |
| (6,442 | ) | |
| 12.07 | |
Balance
– June 30, 2024 | |
| 80,878 | | |
| 26.22 | |
| |
| Stock
options | | |
| Weighted
average exercise price | |
| |
| # | | |
| $ | |
Balance – January 1,
2023 | |
| 64,735 | | |
| 20.46 | |
Granted | |
| 21,004 | | |
| 19.00 | |
Exercised | |
| (472 | ) | |
| 2.92 | |
Cancelled
/ Forfeited | |
| (944 | ) | |
| 19.00 | |
Balance
– June 30, 2023 | |
| 84,323 | | |
| 20.46 | |
Concurrent
with the Transaction described in Note 1, Business Overview, on June 3, 2024, each outstanding stock option was reissued to reflect the
exchange rate of the Company’s common shares and to convert the exercise price into U.S. dollar. Accordingly,
all quantities and prices in these interim condensed consolidated financial statements have been retroactively adjusted for all periods
presented to give effect to the share exchange and related adjustments.
14. Fair value of financial instruments
The
following presents financial assets and liabilities measured at fair value in the statement of financial position in accordance with
the fair value hierarchy.
In
establishing fair value, the Company uses a fair value hierarchy based on levels as defined below:
|
● |
Level
1: quoted prices (unadjusted) in active markets for identical assets or liabilities at the reporting date; |
|
● |
Level
2: inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly;
and |
|
● |
Level
3: inputs that are based on little or no observable market data, therefore requiring entities to develop their own assumptions. |
The
Company has determined that, excluding the derivative warrants, the carrying amounts of its current financial assets and financial liabilities
approximate their fair value given the short-term nature of these instruments.
As
at June 30, 2024 and December 31, 2023, the warrants is the only financial instrument measured at fair value in the condensed interim
consolidated statement of financial position. The warrants having an exercise price of $0.01 are classified in level 2 and their fair
value has been estimated by reference to the quoted price of the underlying shares at the reporting date. The fair value of all other
warrants measured at fair value are classified in level 3.
COSCIENS
Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
15. Supplemental disclosure of cash flow information
Summary of changes in operating assets and liabilities
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three
months ended | | |
Six
months ended | |
| |
June
30, | | |
June
30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| $ | | |
| $ | | |
| $ | | |
| $ | |
Changes in operating assets
and liabilities: | |
| | | |
| | | |
| | | |
| | |
Trade
and other receivables | |
| 427 | | |
| 987 | | |
| (684 | ) | |
| 927 | |
Inventory | |
| 501 | | |
| (673 | ) | |
| 894 | | |
| (1,034 | ) |
Prepaid
expenses and other current assets | |
| 368 | | |
| 51 | | |
| 248 | | |
| 26 | |
Payables
and accrued liabilities | |
| 565 | | |
| (488 | ) | |
| 442 | | |
| (966 | ) |
Provision
for restructuring and other costs | |
| 1 | | |
| - | | |
| 1 | | |
| - | |
Employee
future benefits | |
| (44 | ) | |
| - | | |
| (44 | ) | |
| - | |
Increase
(decrease) in operating assets and liabilities | |
| 1,818 | | |
| (123 | ) | |
| 857 | | |
| (1,047 | ) |
16. Net loss per share
The
following table sets forth pertinent data relating to the computation of basic and diluted net loss per share attributable to common
shareholders.
Summary of pertinent data relating to computation of basic and diluted net loss per share
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three
months ended | | |
Six
months ended | |
| |
June
30, | | |
June
30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| $ | | |
| $ | | |
| $ | | |
| $ | |
Net
loss | |
| (1,422 | ) | |
| (860 | ) | |
| (2,823 | ) | |
| (1,145 | ) |
Basic and diluted weighted-average
shares outstanding | |
| 2,220,303 | | |
| 1,846,775 | | |
| 2,033,539 | | |
| 1,846,759 | |
| |
| | | |
| | | |
| | | |
| | |
Basic and
diluted loss per share | |
| (0.64 | ) | |
| (0.47 | ) | |
| (1.39 | ) | |
| (0.62 | ) |
| |
| | | |
| | | |
| | | |
| | |
Items excluded from the calculation
of diluted net loss per share due to their anti-dilutive effect: | |
| | | |
| | | |
| | | |
| | |
Stock options and DSUs | |
| 130,108 | | |
| 84,323 | | |
| 130,108 | | |
| 84,323 | |
Warrants | |
| 747,948 | | |
| - | | |
| 747,948 | | |
| - | |
COSCIENS
Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
17. Segment information
As
of June 30, 2024 and a result of the transaction, the Company has two reportable and operating segments: Active ingredient and Biopharmaceutical.
The Group’s chief operating decision maker assesses the performance of the reportable segments based on revenues and operating
loss before selling, general & administrative expenses, other income and tax by segment. Selling, general and administrative expenses
are expenses and salaries related to centralized functions, such as corporate finance, legal, human resources and technology teams, which
are not allocated to segments. Accounting policies applied for the Active ingredient and the Biopharmaceutical segments are identical
to those used for the purposes of the consolidated financial statements as described in Note 2.
Active
ingredients
The
Active ingredient segment involves the development of proprietary extraction technologies and the application of these technologies to
the production and development and commercialization of active ingredients derived from oats and other renewable plant resources for
healthcare and cosmetic industries. Active ingredients produced include oat beta glucan, oat oil and avenanthramides. These and similar
manufactured products are sold primarily through distribution networks.
Biopharmaceutical
The
Biopharmaceutical segment includes the results of Aeterna Zentaris from its acquisition on June 3, 2024 (Note 3). The segment involves
the commercializing and developing pharmaceutical therapeutics and diagnostic tests, including the Company’s lead product, Macrilen®
(macimorelin). The segment also includes costs associated with the development of our pre-clinical pipeline to potentially address unmet
medical needs across several indications with a focus on rare or orphan indications.
COSCIENS
Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
The
table below summarizes the relevant financial information by operating segment:
Summary relevant financial information by operating segment
| |
Active
ingredient | | |
Biopharmaceutical | | |
Total | |
| |
Three
months ended June 30, 2024 | |
| |
Active
ingredient | | |
Biopharmaceutical | | |
Total | |
| |
| $ | | |
| $ | | |
| $ | |
Revenue | |
| 2,334 | | |
| 3 | | |
| 2,337 | |
Cost of sales | |
| (1,514 | ) | |
| (4 | ) | |
| (1,518 | ) |
Gross margin | |
| 820 | | |
| (1 | ) | |
| 819 | |
Research
and development | |
| (782 | ) | |
| (748 | ) | |
| (1,530 | ) |
Loss
from operations before SG&A and other income (expenses) | |
| 38 | | |
| (749 | ) | |
| (711 | ) |
Selling,
general & administrative | |
| | | |
| | | |
| (3,044 | ) |
Loss
from operations | |
| | | |
| | | |
| (3,755 | ) |
Net
other income | |
| | | |
| | | |
| 1,859 | |
Loss
before income taxes | |
| | | |
| | | |
| (1,896 | ) |
| |
Active
ingredient | | |
Biopharmaceutical | | |
Total | |
| |
Three
months ended June 30, 2023 | |
| |
Active
ingredient | | |
Biopharmaceutical | | |
Total | |
| |
| $ | | |
| $ | | |
| $ | |
Revenue | |
| 1,392 | | |
| - | | |
| 1,392 | |
Cost of sales | |
| (595 | ) | |
| - | | |
| (595 | ) |
Gross margin | |
| 797 | | |
| - | | |
| 797 | |
Research
and development | |
| (691 | ) | |
| - | | |
| (691 | ) |
Income
from operations before SG&A and other income (expenses) | |
| 106 | | |
| - | | |
| 106 | |
Selling,
general & administrative | |
| | | |
| | | |
| (1,220 | ) |
Loss
from operations | |
| | | |
| | | |
| (1,114 | ) |
Net
other income | |
| | | |
| | | |
| 19 | |
Loss
before income taxes | |
| | | |
| | | |
| (1,095 | ) |
COSCIENS
Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
| |
Active
ingredient | | |
Biopharmaceutical | | |
Total | |
| |
Six
months ended June 30, 2024 | |
| |
Active
ingredient | | |
Biopharmaceutical | | |
Total | |
| |
| $ | | |
| $ | | |
| $ | |
Revenue | |
| 4,391 | | |
| 3 | | |
| 4,394 | |
Cost of sales | |
| (2,667 | ) | |
| (4 | ) | |
| (2,671 | ) |
Gross margin | |
| 1,724 | | |
| (1 | ) | |
| 1,723 | |
Research
and development | |
| (1,844 | ) | |
| (748 | ) | |
| (2,592 | ) |
Loss
from operations before SG&A and other income (expenses) | |
| (120 | ) | |
| (749 | ) | |
| (869 | ) |
Selling,
general & administrative | |
| | | |
| | | |
| (4,710 | ) |
Loss
from operations | |
| | | |
| | | |
| (5,579 | ) |
Net
other income | |
| | | |
| | | |
| 1,870 | |
Loss
before income taxes | |
| | | |
| | | |
| (3,709 | ) |
| |
Active
ingredient | | |
Biopharmaceutical | | |
Total | |
| |
Six
months ended June 30, 2023 | |
| |
Active
ingredient | | |
Biopharmaceutical | | |
Total | |
| |
| $ | | |
| $ | | |
| $ | |
Revenue | |
| 3,977 | | |
| - | | |
| 3,977 | |
Cost of sales | |
| (1,992 | ) | |
| - | | |
| (1,992 | ) |
Gross margin | |
| 1,985 | | |
| - | | |
| 1,985 | |
Research
and development | |
| (1,115 | ) | |
| - | | |
| (1,115 | ) |
Income
from operations before SG&A and other income (expenses) | |
| 870 | | |
| - | | |
| 870 | |
Income
(Loss) from operations before SG&A and other income (expenses) | |
| 870 | | |
| - | | |
| 870 | |
Selling,
general & administrative | |
| | | |
| | | |
| (2,352 | ) |
Loss
from operations | |
| | | |
| | | |
| (1,482 | ) |
Net
other income | |
| | | |
| | | |
| 24 | |
Loss
before income taxes | |
| | | |
| | | |
| (1,458 | ) |
Major
Customer
During
the three and six months ended June 30, 2024, the Company had export sales to one major distributor of the Company’s products representing
87% of total revenue (2023 - 89% of total revenue). As at June 30, 2024, one customer represented 84% of total accounts receivable and
other receivables (June 30, 2023 – one major customer amounted to 92%).
COSCIENS
Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
18. Commitments
Significant
expenditure under contracted supply agreements for at the end of the reporting period but not recognized as liabilities is as follows:
Schedule of expected
future minimum lease payments
| |
TOTAL | |
| |
$ | |
Less than 1 year | |
| 4,352 | |
1 - 3 years | |
| 54 | |
4 - 5 years | |
| - | |
More
than 5 years | |
| - | |
Minimum lease payments, net | |
| 4,406 | |
The
Company executed various agreements including in-licensing and similar arrangements with development partners. Such agreements may require
the Company to make payments on achievement of stages of development, launch or revenue milestones, although the Company generally has
the right to terminate these agreements at no penalty. The Company may have to pay up to $38,573 upon achieving certain sales volumes,
regulatory or other milestones related to specific products.
In
addition, the Company previously entered into license agreements for technologies to increase the concentration of avenanthramides in
oats and the rights to the PGX technology. As part of these agreements the Company shall pay an annual royalty percentage rate of 2.0%
specific avenanthramides sales and up to 3.5% of PGX sales respectively.
The
Company has entered into a purchase commitment with a European specialized engineering firm for the supply of engineering, services and
equipment related to the construction of a PGX-100 pilot plant (note 7). As of June 30, 2024 the remaining purchase commitment is $678
(€727) and is expected to be completed in 2024.
Exhibit 99.2
Management’s
Discussion and Analysis of Financial Condition and Results of Operations
Introduction
This
Management’s Discussion and Analysis (“MD&A”) provides a review of the results of operations, financial condition
and cash flows of COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.) for the three-month and six-month period ended June 30, 2024.
In this MD&A, “COSCIENS”, the “Company”, “we”, “us” and “our” mean COSCIENS
Biopharma Inc. and its subsidiaries. This discussion should be read in conjunction with the information contained in the Company’s
unaudited interim condensed consolidated financial statements (the “unaudited consolidated financial statements”) and the
notes thereto as of June 30, 2024, and for the six-month periods ended June 30, 2024, and 2023. Our unaudited consolidated financial
statements have been prepared in accordance with International Financial Reporting Standards as issued by the International Accounting
Standards Board (“IFRS”).
On
June 3, 2024, Aeterna Zentaris Inc. and Ceapro Inc. closed their all-stock merger of equals transaction and on June 9, 2024, the Company
changed its name to COSCIENS Biopharma Inc. For further details on these transactions and the basis for presentation of this MD&A,
see “Plan of Arrangement” and “Name Change”, below, as well as Note 3 to the unaudited consolidated financial
statements.
The
Company’s common shares are listed on both The Nasdaq Capital Market (“Nasdaq”) and on the Toronto Stock Exchange (“TSX”)
under the symbol “CSCI”.
All
amounts in this MD&A are presented in thousands of United States (“U.S.”) dollars, except for share and per share data,
or as otherwise noted. This MD&A was approved by the Company’s Board of Directors (the “Board”) on August 12, 2024.
This MD&A is dated August 12, 2024.
About
Forward-Looking Statements
The
information in this MD&A has been prepared as of August 12, 2024. Certain statements in this MD&A, referred to herein as “forward-looking
statements”, constitute “forward-looking statements” within the meaning of the United States Private Securities Litigation
Reform Act of 1995, as amended, and “forward-looking information” under the provisions of Canadian securities laws. All statements,
other than statements of historical fact, that address circumstances, events, activities, or developments that could or may or will occur
are forward-looking statements. When used in this MD&A, words such as “anticipate”, “assume”, “believe”,
“could”, “expect”, “forecast”, “future”, “goal”, “guidance”,
“intend”, “likely”, “may”, “would” or the negative or comparable terminology as well
as terms usually used in the future and the conditional are generally intended to identify forward-looking statements, although not all
forward-looking statements include such words.
Forward-looking
statements in this MD&A include, but are not limited to, statements, comments and expectations relating to: the Company’s patented
technologies and value-driving products, and development thereof; Macrilen® (macimorelin) and the Company’s plans
in respect of same, including commercialization and clinical programs; the Company’s business strategy; the Company’s positioning
in its target markets; the Company’s ability to accelerate the scale-up of PGX Technology towards commercial levels; pre-clinical
and clinical studies and trials and their expected timing and results, including the potential to bring certain products to market following
such studies and trials; the ability of our pharmaceutical therapeutic assets to address unmet medical needs across a number of indications;
management’s assumptions, estimates and judgments; liquidity and capital resources; adequacy of our financial resources to finance
operations and expenditure requirements; limitations on internal controls over financial reporting; and the plans, objectives, future
outlook and financial position of the Company in general. Forward-looking statements are necessarily based upon a number of factors and
assumptions that, while considered reasonable by the Company as of the date of such statements, are inherently subject to significant
business, economic, operational and other risks, uncertainties, contingencies and other factors, including those described below, which
could cause actual results, performance or achievements of the Company to be materially different from results, performance or achievements
expressed or implied by such forward-looking statements and, as such, undue reliance must not be placed on them.
Forward-looking
statements involve known and unknown risks and uncertainties which include, among others: the Company’s present and future business
strategies; operations performance within expected ranges; anticipated future cash flows; local and global economic conditions and the
environment in which the Company operates; anticipated capital and operating costs; uncertainty in technology development as well as
product development and related clinical trials and validation studies, including our reliance on the success of the pediatric clinical
trial in the European Union and U.S. for Macrilen® (macimorelin); the result of the DETECT-trial may not support receipt
of regulatory approval in child-onset growth hormone deficiency; results from ongoing or planned pre-clinical studies of macimorelin
by the University of Queensland or for our other products under development may not be successful or may not support advancing the product
to human clinical trials; our ability to raise capital and obtain financing to continue our currently planned operations; our now heavy
dependence on the success of Macrilen® (macimorelin) and related out-licensing arrangements and the continued availability
of funds and resources to successfully commercialize the product; the ability to secure strategic partners for late stage development,
marketing, and distribution of our products, including our ability to enter into a new license agreement or similar arrangement following
the termination of the license agreement with Novo Nordisk AG; our ability to enter into out-licensing, development, manufacturing, marketing
and distribution agreements with other pharmaceutical companies and keep such agreements in effect; our ability to protect and enforce
our patent portfolio and intellectual property; and our ability to continue to list our common shares on the Nasdaq.
Investors
should consult our quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks
and uncertainties, including those discussed in our Annual Report on Form 20-F and under the heading “Risks and Uncertainties”
in Exhibit 99.2 of our Form 6-K furnished to the SEC on May 14, 2024 filed under the Company’s profile on SEDAR+ at www.sedarplus.ca
and on EDGAR at www.sec.gov. We disclaim any obligation to update any such risks or uncertainties or to publicly announce any revisions
to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so
by a governmental authority or applicable law.
Certain
forward-looking statements contained herein about prospective results of operations, financial position or cash flows may constitute
a financial outlook. Such statements are based on assumptions about future events that management believe to be reasonable, are given
as of the date hereof and are based on economic conditions, proposed courses of action and management’s assessment of currently
available relevant information. The Company’s management has approved the financial outlook as of the date hereof. Readers are
cautioned that such financial outlook information contained herein should not be used for purposes other than for which it is disclosed
herein.
About
Material Information
This
MD&A includes information that we believe to be material to investors after considering all circumstances. We consider information
and disclosures to be material if they result in, or would reasonably be expected to result in, a significant change in the market price
or value of our securities, or where it is likely that a reasonable investor would consider the information and disclosures to be important
in making an investment decision.
We
are a reporting issuer under the securities legislation of all of the provinces of Canada, and our securities are registered with the
U.S. Securities and Exchange Commission (“SEC”). We are therefore required to file or furnish continuous disclosure information,
such as interim and annual financial statements, management’s discussion and analysis, proxy or information circulars, annual reports
on Form 20-F, material change reports and press releases with the appropriate securities regulatory authorities. Additional information
about the Company and copies of these documents may be obtained free of charge upon request from our Corporate Secretary or on the Internet
at the following addresses: www.cosciensbio.com, www.sedarplus.ca and www.sec.gov.
Company
Overview
COSCIENS
Biopharma Inc. is a specialty biopharmaceutical company developing and commercializing a diversified portfolio of products for the cosmeceutical,
nutraceutical and pharmaceutical markets. Such products being produced using the Company’s proprietary technologies. The
Company’s patented technologies include the Pressurized Gas eXpanded (PGX) technology, which is a unique and disruptive technology
that generates high-value yields of active ingredients from natural plant resources for use in novel cosmeceutical, nutraceutical and
therapeutics products. The Company’s two value-driving products, oat beta glucan and avenanthramides, are found in many household
name cosmetic and personal care brands. These products are manufactured from the Company’s proprietary oat extraction manufacturing
technology and are known for their well-documented health benefits.
The
Company’s lead pharmaceutical product, macimorelin (Macrilen®; Ghryvelin®), is the first and only
U.S. FDA and European Commission approved oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD). The Company
is leveraging the clinical success and compelling safety profile of macimorelin to develop it for the diagnosis of childhood-onset growth
hormone deficiency (CGHD), an area of significant unmet need.
The
Company is also dedicated to the development of its therapeutic assets and has established a pre-clinical development pipeline to potentially
address unmet medical needs across a number of indications, including treatment of inflammation-based diseases, idiopathic pulmonary
fibrosis (IPF), neuromyelitis optica spectrum disorder (NMOSD), Parkinson’s disease (PD), hypoparathyroidism and amyotrophic lateral
sclerosis (ALS; Lou Gehrig’s disease).
Plan
of arrangement
On
June 3, 2024, Aeterna Zentaris Inc. (“Aeterna”) and Ceapro Inc. (“Ceapro”) closed their all-stock merger of equals
transaction (the “Transaction”). The Transaction was completed by way of court approved plan of arrangement pursuant to the
terms of an arrangement agreement entered into by Aeterna and Ceapro on December 14, 2023. As a result of the Transaction, each outstanding
Ceapro common share was exchanged for 0.02360 of an Aeterna common share. Additionally, as part of the Transaction, Aeterna issued to
its shareholders immediately prior to the closing of the Transaction, 0.47698 of a share purchase warrant (a “New Warrant”)
for each Aeterna common share or warrant held.
Following
the closing of the Transaction, former shareholders of Ceapro owned approximately 50% of the Aeterna common shares on a fully diluted
basis and former shareholders of Aeterna owned approximately 50% of the Aeterna common shares on a fully diluted basis. For financial
reporting and accounting purposes, Ceapro was the acquirer of Aeterna in the Transaction. The consolidated financial statements of COSCIENS
Biopharma Inc. as of June 30, 2024, and December 31, 2023 and for the three and six months ended June 30, 2024 and 2023 reflect the results
of operations and financial position of Ceapro for the periods presented and includes 28 days of the results of operations of Aeterna
for the three and six months ended June 30, 2024 subsequent to the Transaction, which was completed on June 3, 2024.
The
accompanying consolidated financial statements include the accounts of COSCIENS Biopharma Inc. Inc., an entity incorporated under the
Canada Business Corporations Act, and its wholly owned subsidiaries (the “Group”). COSCIENS Biopharma Inc. Inc. is
the ultimate parent company of the Group. The Company currently has six wholly-owned direct and indirect subsidiaries, Ceapro Inc. and
its wholly-owned subsidiaries Ceapro (P.E.I.) and JuventeDC Inc., based in Canada, Aeterna Zentaris GmbH (“AEZS Germany”)
and its wholly-owned subsidiary Zentaris IVF GmbH, based in Frankfurt, Germany, and Aeterna Zentaris, Inc., an entity incorporated in
the state of Delaware and with offices in Summerville, South Carolina, in the US.
Name
Change
At
the Company’s annual general and special meeting of shareholders held on July 16, 2024 (while the Company was known as Aeterna
Zentaris Inc.), the shareholders of the Company approved a special resolution authorizing the Board to effect a change of name of the
Company from “Aeterna Zentaris Inc.” to “COSCIENS Biopharma Inc.” (the “Name Change”). On August
6, 2024, the Company filed articles of amendment pursuant to the Canada Business Corporations Act in order to effect the Name
Change.
On
August 9, 2024, the Company’s common shares began trading on the TSX and Nasdaq under the trading symbol “CSCI”, and
concurrently ceased trading thereon under the former trading symbol “AEZS”. The Name Change did not result in any changes
in the capitalization of the Company.
Key
Operational Developments
Active
ingredients
The
Company’s active ingredient segment focuses on leveraging our unique expertise in the extraction, production and commercialization
of active ingredients from natural sources. The Company’s commercialized products are well positioned in the cosmeceutical market
and mostly focused on the documented health benefits of two bio actives extracted from oats; beta glucan and avenanthramides. These products
include:
|
● |
A
commercial line of natural active ingredients, including beta glucan, avenanthramides (colloidal oat extract), oat powder, oat oil,
and oat peptides, which are marketed to the personal care, cosmetic, medical, and animal health industries through our distribution
partners and direct sales; |
|
● |
A
commercial line of natural anti-aging skincare products, utilizing active ingredients including oat beta glucan and avenanthramides,
which are marketed to the cosmeceuticals market through our wholly owned subsidiary, JuventeDC Inc.; and |
|
● |
Veterinary
therapeutic products, including an oat shampoo, an ear cleanser, and a dermal complex/conditioner, which are manufactured and marketed
to veterinarians in Japan and Asia. |
The
Company’s core technologies used to extract and process bio actives include proprietary Ethanol Fractionation Processes (EFP) and
Pressurized Gas eXpanded (PGX) Technology. EFP is mostly used to produce liquid formulations while PGX is used for powder formulations.
PGX is a patented, unique and disruptive technology with several key advantages over conventional drying and purification technologies
that can be used to process biopolymers into high-value and novel biocomposites. In a single step and using green solvents, It has the
ability to make generates purified highly porous polymer composites such as aerogels which cannot be made using conventional drying technologies.
In 2023, the Company commenced a collaboration with Austria-based NATEX Prozesstechnologie GesmbH to accelerate the scale-up of PGX Technology
towards commercial levels at both its Edmonton facility and at the Natex Termitz facility, which are both expected to be completed in
2024.
Given
the well-known properties of oat beta glucan and avenanthramides as cholesterol reducer and anti-inflammation respectively, we are actively
developing our oat-based pipeline products to address unmet needs within the nutraceuticals markets, with a strategic focus on:
Oat
Beta Glucan – Chewable for cholesterol reduction
Leveraging
approved claims for the use of oat beta glucan as a proven cholesterol reduction ingredient in Canada, the United States of America and
the European Union, and having received approval from Health Canada in December 2023, the Company has formulated a healthy edible product
capable of delivering the appropriate dose of oat beta glucan to meet all regulatory and health requirements. Commercial manufacturing
samples have been produced, proving manufacturability of a healthy and delicious edible product despite the high levels of oat beta glucan
required to provide a scientifically proven cholesterol reduction in humans. The Company intends to bring this product to the wellness
and functional food market B2C via various e-commerce platforms.
Avenanthramides
– nutraceutical-chewable formulation to reduce inflammation
In
addition to cosmetic applications, avenanthramides, when taken orally, could treat inflammation-based conditions such as exercise induced
inflammation, joint inflammation as well as inflammation at the gastro-intestinal and cardiovascular levels.
Through
the use of a unique chromatography purification technology, the Company has successfully developed a highly purified and well characterized
pharmaceutical grade powder formulation with the goal that such active pharmaceutical ingredient (API) could be offered as both nutraceutical
and pharmaceutical formulations.
The
Company’s initial activities for use of avenanthramides in nutraceuticals were focused on assessing the bio-availability and bio-efficacy
of the compound under the leadership of Dr. Li Li Ji at the University of Minnesota. Following the completion of the bio-availablity
study in 2018, the Company successfully completed two bio-efficacy studies in 2019 using low and high doses of avenanthramides with young
men and women demonstrating in a statistically significant manner the efficacy of avenanthramides in alleviating exercise-induced inflammation
as evidenced by a significant decrease of inflammation biomarkers in the blood. These studies paved the way for the development of products
like superfine oat flour enriched with Avenanthramides used for the production of chewable oat bar as a nutraceutical as well as for
the development of a pharmaceutical grade tablet for clinical trials. The Company is initiating the production of enriched oat flour
at small commercial scale at the Edmonton facility.
Beta
glucan from yeast (YBG)- nutraceutical-capsule as an immune booster
While
yeast beta glucan is a commercial product with well-known immune properties, the obtention of a consistently high-purity product represents
a major challenge for suppliers. Using the PGX technology, the company has successfully processed several formulations of yeast beta
glucan and is now in a position to offer a very high purity YBG product with very well-defined specifications. The company further demonstrated
the mechanism of action following in vitro and in vivo studies.
This
product has been used for the completion of the 5 times scale-up of the PGX technology at the Edmonton facility and will also be used
for the 10 times scale-up work being conducted in Austria. Powder formulation produced in Edmonton will be offered in capsules as an
immune booster product.
Pharmaceutical
The
Company is also dedicated to the development of its pharmaceutical therapeutic assets and has established a clinical and pre-clinical
development pipeline to potentially address unmet medical needs across a number of indications, including diagnostic tests for growth
hormone deficiency, potential treatment of inflammation based diseases, and fibrotic diseases such idiopathic pulmonary fibrosis (IPF),
neurodegenerative conditions like neuromyelitis optica spectrum disorder (NMOSD), Parkinson’s disease (PD), hypoparathyroidism),
amyotrophic lateral sclerosis (ALS; Lou Gehrig’s disease).) and endocrinology pathologies like hypoparathyroidism.
Macimorelin
Commercialization Program
Macrilen®
(macimorelin), is the first and only U.S. Food and Drug Administration (“FDA”) and European Medicines Agency (“EMA”)
approved oral test indicated for the diagnosis of patients with adult growth hormone deficiency (“AGHD”). Macimorelin is
currently marketed under the tradename Ghryvelin® in the European Economic Area and the United Kingdom through an exclusive
licensing agreement with Pharmanovia. To date the product has launched in the United Kingdom, Sweden, Denmark, Finland, Germany, Netherlands
and Austria. More EU countries will follow pending re-imbursement negotiations. The Company’s several other license and commercialization
partners are also seeking approval for commercialization of macimorelin in Israel and the Palestinian Authority, the Republic of Korea,
Turkey and several non-European Union Balkan countries. The Company is actively pursuing business development opportunities for the commercialization
of macimorelin in North America, Asia and the rest of the world.
Macimorelin
Clinical Program
In
late 2020, the Company entered into the start-up phase for the clinical safety and efficacy study, AEZS-130-P02 (“DETECT-trial”),
evaluating macimorelin for the diagnosis of child growth hormone deficiency (CGHD). The DETECT-trial is an open-label, single dose, multicenter
and multinational study was expected to enroll approximately 100 subjects worldwide (incl. sites in U.S: and EU), with at least 40 pre-pubertal
and 40 pubertal subjects. The study design was expected to be suitable to support a claim for potential stand-alone testing, if successful.
On April 22, 2021, the U.S. FDA Investigational New Drug Application associated with this clinical trial became active, (see: https://clinicaltrials.gov/ct2/show/NCT04786873),
and in Q2, 2024, the last patient visit was conducted successfully in Europe and the study had enrolled a combined 100 subjects in Europe
and North America. The Company remains on track to report top-line data for the DETECT-trial in Q3 2024.
Avenanthramides
for Potential Applications in Inflammation Based Diseases
Avenanthramides
have garnered significant interest due to their suggested bioactivities, including potent antioxidant and anti-inflammatory effects both
in vitro and in vivo. In November 2023, the Company initiated its Phase 1 safety study evaluating its flagship product,
avenanthramides, for potential applications in managing conditions related to inflammation. The Phase 1-2a study (“AvenActive”)
is a double-blind, placebo-controlled, randomized, adaptive, first-in-human study designed to assess safety, tolerability, and pharmacokinetics
of single and multiple ascending oral doses of avenanthramide. 72 healthy subjects will be enrolled in the Phase 1 portion of the trial.
The single ascending dose (SAD) arm includes 6 cohorts of 8 healthy subjects, while the multiple ascending dose (MAD) arm will include
3 cohorts of 8 healthy subjects.
The
first arm of the SAD phase of the study has been completed with 6 groups of 8 healthy subjects per group received doses ranging from
30mg to 960mg per group per day. No significant adverse reactions have been observed during this SAD phase. The Company expects to initiate
the MAD arm during Q3, the summer 2024. Following the Phase 1 portion, pending successful results, the AvenActive protocol also includes
a Phase 2a portion for patients presenting evidence of mild to moderate inflammation. A total of 24 patients will be enrolled in the
Phase 2a portion.
The
Phase 1-2a trial is designed to evaluate the safety profile of avenanthramides and gather initial insights into its potential efficacy.
As the trial progresses, the Company remains focused on collaborating with regulatory authorities, healthcare professionals, and patient
communities to bring this innovative therapy to market.
Yeast
Beta Glucan as treatment for Idiopathic Pulmonary Fibrosis (IPF)
IPF
is a progressive disease with a median survival from 2-7 years. While IPF can occur at any age, up to 1 out of every 200 individuals
above age 65 will have IPF. With an aging population as well as a significant number of COVID-19 patients developing IPF post infection,
prevalence and impact of IPF are expected to grow.
PGX-processed
yeast beta glucan (PGX-YBG) can be uniformly “loaded” with a variety of bioactives as a delivery system for inhaled therapeutics.
In 2019, the Company, in partnership with McMaster University, initiated a review of preliminary data collected to assess delivery systems
to optimize drug formulations used for treatment of Idiopathic Pulmonary Fibrosis (IPF). While yeast beta glucan appeared to be a promising
compound, researchers believe the ideal formulation to treat fibrotic lung disorders would be to develop an inhalable complex produced
by loading a currently marketed drug onto PGX-YBG. Following preliminary experiments with PGX-YBG alone and in combination with the commercialized
a drug, the team concluded that PGX-YBG could be used as a stand-alone the active component to treat fibrotic in a new antifibrotic treatment
for the most severe lung diseases including COVID-19 patients.
In
2023, in partnership with McMaster University, we completed a further pre-clinical CHRP study evaluating PGX-YBG as a potential therapeutic
option for individuals suffering from interstitial lung diseases (ILD). The positive results from the CHRP study not only, demonstrated
that PGX-YBG was respirable, but it could safely and reliably reprogram macrophages in the lungs of mice, providing confidence in
its potential to safely penetrate deep into human lungs when self-administered using a hand-held inhaler. These results were presented
at the 2023 CSPS/CC-CRS Annual Symposium – The Next Frontiers in Pharmaceutical Sciences to on May 24-26, 2023.
The
company is evaluating the next steps for PGX-YBG for ILD. If the company decides to progress it to clinical trial as a potential inhalable
immune-therapeutic treatment for severe forms of ILD which may include IPF and COVID-19 related lung fibrosis, we would first be required
to undertake and obtain results from IND enabling toxicology studies before.
AIM
Biologicals: Targeted, highly specific autoimmunity modifying therapeutics for the potential treatment of neuromyelitis optica spectrum
disorder (NMOSD) and Parkinson’s disease
AIM
Biologicals are based on a natural process during pregnancy, which induces immunogenic tolerance of the maternal immune system to the
partially foreign fetal antigens. Fetal proteins are processed and presented on certain immunosuppressive major histocompatibility complex
class I molecules to induce this tolerance. In an autoimmune disease, the immune system is misdirected and targets the body’s own
protein. With AIM Biologicals, we aim to restore the tolerance against such proteins to treat autoimmune diseases. Our AIM Biologics
program is focused on the rare and orphan indication NMOSD and on the second most common neurodegenerative disorder, Parkinson’s
disease.
In
January 2021, we entered into an exclusive patent license and research agreement with the University of Wuerzburg, Germany, for worldwide
rights to develop, manufacture, and commercialize AIM Biologicals for the potential treatment of NMOSD. Additionally, we have engaged
neuro-immunologist Dr. Michael Levy from the Massachusetts General Hospital (“MGH”) in Boston as consultants for scientific
support and advice in the field of inflammatory central nervous system “CNS” disorders, autoimmune diseases of the nervous
system, and NMOSD. In September 2021, we entered into an additional exclusive license with the University of Wuerzburg for early pre-clinical
development towards the potential treatment of Parkinson’s disease. On May 12, 2022 we announced positive pre-clinical results
in an innovative mouse model of Parkinson’s disease, where treatment with α-Synuclein specific AIM Biologicals showed a trend
towards improved motoric function, as well as significant induction of regulatory T cells and rescue of substantia nigra neurons. The
data were presented at IMMUNOLOGY2022™, the annual event of the American Association of Immunologists, held on May 6-10, 2022 in
Portland, Oregon. On June 13, 2022, we announced that we had achieved proof-of-concept for the treatment of NMOSD in both in-vitro
and in mouse models. These findings were presented at the 13th International Congress on Autoimmunity on June 10-13, 2022,
in Athens, Greece. In October 2022, we entered into a research and development agreement with MGH in Boston and Dr. Michael Levy, to
conduct pre-clinical ex-vivo and in-vivo studies in NMOSD.
NMOSD
is an autoimmune disease targeting the protein aquaporin 4, primarily found in optic nerves and the spinal cord. The disease leading
to blindness and paralysis has a prevalence of 0.7-10 in 100,000. NMOSD progresses in often life-threatening relapses, which are aggressively
treated with high-dose steroids and plasmapheresis. Current treatment options include treatment with immunosuppressive monoclonal antibodies,
which carries risk of serious infections. We are evaluating the data obtained to date and considering our plans for the treatment
of NMOSD using an AIM Biologicals platform.
Parkinson’s
disease is a neurological disease commonly associated with motoric problems with a slow and fast progression form. It is the second most
common neurodegenerative disease affecting 10 million people worldwide. The hallmark of PD is the neuronal inclusion of mainly α-synuclein
protein (αSyn) associated with the death of dopamine-producing cells. Dopaminergic medication is the mainstay treatment of PD symptoms.
Up to now there is no pharmacological therapy available to prevent or delay disease progression. For the development of AIM Biologicals
as potential PD therapeutics, Aeterna utilizes, among others, an innovative animal model on neurodegeneration by α-synuclein-specific
T cells in AAV-A53T-α-synuclein Parkinson’s disease mice, which has recently been published by University of Wuerzburg researchers.
We are currently continuing in-vitro and in-vivo testing of antigen-specific AIM Biologics candidate molecules for
the potential treatment of Parkinson’s disease.
AEZS-150
– Delayed Clearance (“DC”) Parathyroid Hormone (“PTH”) (“DC-PTH”) Fusion Polypeptides: Potential
treatment for chronic hypoparathyroidism
On
March 11, 2021, we entered into an exclusive license agreement with The University of Sheffield, United Kingdom, for the intellectual
property relating to PTH fusion polypeptides covering the field of human use, which will initially be studied by Aeterna for the potential
therapeutic treatment of chronic hypoparathyroidism (“HypoPT”). Under the terms of the agreement, we obtained worldwide rights
to develop, manufacture and commercialize PTH fusion polypeptides covered by the licensed patent applications for all human uses. We
will be responsible for the further development, manufacturing, approval, and commercialization of the licensed products.
The
researchers at the University of Sheffield have developed a method to increase the serum clearance time of peptides, which the Company
is applying to the development of a treatment for HypoPT. HypoPT is an orphan disease where the PTH level is abnormally low or absent,
with a prevalence per 100,000 of 37 in the U.S., 22 in Denmark, 9.4 in Norway, and 5.3 to 27 in Italy. Standard treatment is calcium
and vitamin D supplementation. The lead candidate AEZS-150 is being developed to provide a weekly treatment option of chronic hypoparathyroidism
in adults. Recent progress includes the successful verification and reproduction of previous in-vivo data from the University of Sheffield,
in a rat model of hypoparathyroidism. We are also reviewing the potential manufacturing process for AEZS-150 with the Company’s
contract development and manufacturing organization.
AEZS-130
- Macimorelin Pre-clinical Program
On
January 13, 2021, we entered into a material transfer agreement with Queensland University and subsequently in July 2022, into a research
and option to license agreement with UniQuest Pty Ltd., the commercialization company of The University of Queensland (UQ), Brisbane,
Australia, to conduct of preclinical studies and advance the development of macimorelin as a potential therapeutic for the treatment
of ALS.
ALS is a rare progressive neurological disease primarily affecting the neurons controlling voluntary movement, leading to the disability
to control movements such as walking, talking, and chewing. Most people with ALS die from respiratory failure, usually between 3-5 years
after diagnosis. Currently there is no cure for ALS and no effective treatment to halt or reverse the progression of the disease. Ghrelin
is a hormone with wide-ranging biological actions, most known for stimulating growth hormone release, which is demonstrating emerging
evidence as therapeutic for ALS.
Through
research we are funding at The University of Queensland, we have been conducting pre-clinical experiments to seek to identify a potential
alternative formulation suitable for use in ALS patients, the results of which we are currently evaluating.
Condensed
Interim Consolidated Statements of Loss and Comprehensive Loss Data
(in thousands of US dollars, except loss per share) | |
Three months ended | | |
Six months ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
$ | | |
$ | | |
$ | | |
$ | |
Revenues | |
| 2,337 | | |
| 1,392 | | |
| 4,394 | | |
| 3,977 | |
Cost of sales | |
| (1,518 | ) | |
| (595 | ) | |
| (2,671 | ) | |
| (1,992 | ) |
Gross profit | |
| 819 | | |
| 797 | | |
| 1,723 | | |
| 1,985 | |
| |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 1,530 | | |
| 691 | | |
| 2,592 | | |
| 1,115 | |
Selling, general and administrative | |
| 3,044 | | |
| 1,220 | | |
| 4,710 | | |
| 2,352 | |
Loss from operations | |
| (3,755 | ) | |
| (1,114 | ) | |
| (5,579 | ) | |
| (1,482 | ) |
| |
| | | |
| | | |
| | | |
| | |
Gain due to changes in foreign currency | |
| 17 | | |
| - | | |
| 42 | | |
| - | |
Finance costs | |
| (22 | ) | |
| (24 | ) | |
| (85 | ) | |
| (90 | ) |
Other income | |
| 109 | | |
| 43 | | |
| 158 | | |
| 114 | |
Change in fair value of warrant and DSU liabilities | |
| 1,755 | | |
| - | | |
| 1,755 | | |
| - | |
Other income | |
| 1,859 | | |
| 19 | | |
| 1,870 | | |
| 24 | |
| |
| | | |
| | | |
| | | |
| | |
Loss before income taxes | |
| (1,896 | ) | |
| (1,095 | ) | |
| (3,709 | ) | |
| (1,458 | ) |
| |
| | | |
| | | |
| | | |
| | |
Income tax recovery | |
| 474 | | |
| 235 | | |
| 886 | | |
| 313 | |
Net loss | |
| (1,422 | ) | |
| (860 | ) | |
| (2,823 | ) | |
| (1,145 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other comprehensive loss: | |
| | | |
| | | |
| | | |
| | |
Items that may be reclassified subsequently to profit or loss: | |
| | | |
| | | |
| | | |
| | |
Foreign currency translation adjustments | |
| (47 | ) | |
| 479 | | |
| (506 | ) | |
| 546 | |
Comprehensive loss | |
| (1,469 | ) | |
| (381 | ) | |
| (3,329 | ) | |
| (599 | ) |
| |
| | | |
| | | |
| | | |
| | |
Basic and diluted loss per share | |
| (0.64 | ) | |
| (0.47 | ) | |
| (1.39 | ) | |
| (0.62 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted average number of shares outstanding (basic and diluted) | |
| 2,220,303 | | |
| 1,846,775 | | |
| 2,033,539 | | |
| 1,846,759 | |
Summarized
Interim Consolidated Statements of Financial Position Data
(in thousands of US dollars) | |
June 30, 2024 | | |
December 31,
2023 | |
| |
$ | | |
$ | |
Cash and cash equivalents | |
| 27,804 | | |
| 6,678 | |
Trade and other receivables and other current assets | |
| 4,020 | | |
| 1,398 | |
Inventory | |
| 3,055 | | |
| 4,009 | |
Restricted cash equivalents | |
| 332 | | |
| 8 | |
Property, equipment and intangible assets | |
| 14,834 | | |
| 11,652 | |
Total assets | |
| 50,045 | | |
| 23,745 | |
Payables and accrued liabilities and income taxes payable | |
| 5,949 | | |
| 1,012 | |
Current portion of provisions | |
| 430 | | |
| - | |
Current portion of deferred revenues | |
| 97 | | |
| - | |
Lease liabilities | |
| 1,687 | | |
| 1,698 | |
Non-financial non-current liabilities (1) | |
| 15,655 | | |
| - | |
Total liabilities | |
| 23,818 | | |
| 2,710 | |
Shareholders’ equity | |
| 26,227 | | |
| 21,035 | |
Total liabilities and shareholders’ equity | |
| 50,045 | | |
| 23,745 | |
(1) |
Comprised
mainly of employee future benefits, provisions and non-current portion of deferred revenues. |
Revenue
and cost of sales
The
following table summarizes our gross margin earned during the periods indicated:
(in thousands of US dollars, except percentages) | |
Three months ended June 30, | |
| |
2024 | | |
2023 | | |
Change | | |
Change | |
| |
$ | | |
$ | | |
$ | | |
% | |
Revenue | |
| | | |
| | | |
| | | |
| | |
Active ingredients | |
| 2,334 | | |
| 1,392 | | |
| 942 | | |
| 68 | % |
Pharmaceutical | |
| 3 | | |
| - | | |
| 3 | | |
| 100 | % |
Total revenue | |
| 2,337 | | |
| 1,392 | | |
| 945 | | |
| 68 | % |
Cost of sales | |
| | | |
| | | |
| | | |
| | |
Active ingredients | |
| 1,514 | | |
| 595 | | |
| 919 | | |
| 154 | % |
Pharmaceutical | |
| 4 | | |
| - | | |
| 4 | | |
| 100 | % |
Total cost of sales | |
| 1,518 | | |
| 595 | | |
| 923 | | |
| 155 | % |
Gross Margin | |
| 819 | | |
| 797 | | |
| 22 | | |
| | |
Gross Margin % | |
| 35 | % | |
| 57 | % | |
| | | |
| | |
Our
total revenue for the three-month period ended June 30, 2024, increased by $0.9 million. The increase was due to higher sales of Avenanthramides,
Beta Glucan and Oat Oil in the quarter as compared to the same period in 2023. Cost of sales for the three-month period ended June 30,
2024, increased by $0.9 million. The increase was due primarily to the higher sales volumes during the period as well as an increase
in production costs from prior period.
(in thousands of US dollars, except percentages) | |
Six months ended June 30, | |
| |
2024 | | |
2023 | | |
Change | | |
Change | |
| |
$ | | |
$ | | |
$ | | |
% | |
Revenue | |
| | | |
| | | |
| | | |
| | |
Active ingredients | |
| 4,391 | | |
| 3,977 | | |
| 414 | | |
| 10 | % |
Pharmaceutical | |
| 3 | | |
| - | | |
| 3 | | |
| 100 | % |
Total revenue | |
| 4,394 | | |
| 3,977 | | |
| 417 | | |
| 10 | % |
Cost of sales | |
| | | |
| | | |
| | | |
| | |
Active ingredients | |
| 2,667 | | |
| 1,992 | | |
| 675 | | |
| 34 | % |
Pharmaceutical | |
| 4 | | |
| - | | |
| 4 | | |
| 100 | % |
Total cost of sales | |
| 2,671 | | |
| 1,992 | | |
| 679 | | |
| 34 | % |
Gross Margin | |
| 1,723 | | |
| 1,985 | | |
| (262 | ) | |
| | |
Gross Margin % | |
| 39 | % | |
| 50 | % | |
| | | |
| | |
Our
total revenue for the six-month period ended June 30, 2024, increased by $0.4 million. The increase was due to higher sales of Avenanthramides
and Beta Glucan in the first half of 2024 as compared to the same period in 2023. Cost of sales for the six-month period ended June 30,
2024, increased by $0.7 million. The increase was due primarily due to the higher sales volumes during the period as well as an increase
in production costs from prior period.
Research
and development expenses
The
following table summarizes our research and development expenses incurred during the periods indicated:
(in thousands of US dollars, except percentages) | |
Three months ended June 30, | |
| |
2024 | | |
2023 | | |
Change | | |
Change | |
| |
$ | | |
$ | | |
$ | | |
% | |
Direct research and development expenses: | |
| | | |
| | | |
| | | |
| | |
Avenanthramides for inflammation-based diseases | |
| 522 | | |
| 262 | | |
| 260 | | |
| 99 | % |
Macimorelin pediatric DETECT-trial | |
| 381 | | |
| - | | |
| 381 | | |
| 100 | % |
PGX | |
| 19 | | |
| 44 | | |
| (25 | ) | |
| -57 | % |
Additional programs | |
| 286 | | |
| 190 | | |
| 96 | | |
| 51 | % |
Sub total | |
| 1,208 | | |
| 496 | | |
| 712 | | |
| 144 | % |
Employee-related expenses | |
| 301 | | |
| 190 | | |
| 111 | | |
| 58 | % |
Facilities, depreciation, and other expenses | |
| 21 | | |
| 5 | | |
| 16 | | |
| 320 | % |
Total | |
| 1,530 | | |
| 691 | | |
| 839 | | |
| 121 | % |
Our
total research and development expenses for the three-month period ended June 30, 2024, were $1.5 million as compared to $0.7 million
for the same period in 2023, an increase of $0.8 million. This increase was primarily due to:
|
● |
Increased
spending on the phase 1-2a clinical study on avenanthramides for inflammation-based diseases with the MHI of $0.3 million; and |
|
● |
An
increase in trial costs associated with the DETECT trial of $0.4 million and increases in employee-related costs of $0.1 million,
attributable to the acquisition of Aeterna. |
(in thousands of US dollars, except percentages) | |
Six months ended June 30, | |
| |
2024 | | |
2023 | | |
Change | | |
Change | |
| |
$ | | |
$ | | |
$ | | |
% | |
Direct research and development expenses: | |
| | | |
| | | |
| | | |
| | |
Avenanthramides for inflammation-based diseases | |
| 1,273 | | |
| 299 | | |
| 974 | | |
| 326 | % |
Macimorelin pediatric DETECT-trial | |
| 381 | | |
| - | | |
| 381 | | |
| 100 | % |
PGX | |
| 49 | | |
| 85 | | |
| (36 | ) | |
| -42 | % |
Additional programs | |
| 336 | | |
| 302 | | |
| 34 | | |
| 11 | % |
Sub total | |
| 2,039 | | |
| 686 | | |
| 1,353 | | |
| 197 | % |
Employee-related expenses | |
| 526 | | |
| 418 | | |
| 108 | | |
| 26 | % |
Facilities, depreciation, and other expenses | |
| 27 | | |
| 11 | | |
| 16 | | |
| 145 | % |
Total | |
| 2,592 | | |
| 1,115 | | |
| 1,477 | | |
| 132 | % |
Our
total research and development expenses for the six-month period ended June 30, 2024, were $2.6 million as compared to $1.1 million for
the same period in 2023, an increase of $1.5 million. This increase was primarily due to:
|
● |
Increased
spending on the phase 1-2a clinical study on avenanthramides for inflammation-based diseases with the MHI of $1.0 million; and |
|
● |
An
increase in trial costs associated with the DETECT trial of $0.4 million and increases in employee-related costs of $0.1 million,
attributable to the acquisition of Aeterna. |
Selling,
general and administrative expenses
The
following table summarizes our Selling, general and administrative expenses incurred during the period indicated:
(in thousands of US dollars, except percentages) | |
Three months ended June 30, | |
| |
2024 | | |
2023 | | |
Change | | |
Change | |
| |
$ | | |
$ | | |
$ | | |
% | |
Selling, general and administrative expenses: | |
| | | |
| | | |
| | | |
| | |
Salaries & benefits | |
| 492 | | |
| 513 | | |
| (21 | ) | |
| -4 | % |
Insurance | |
| 117 | | |
| 58 | | |
| 59 | | |
| 102 | % |
Professional fees | |
| 1,339 | | |
| 232 | | |
| 1,107 | | |
| 477 | % |
Other office & general expenses | |
| 1,096 | | |
| 417 | | |
| 679 | | |
| 163 | % |
Total selling, general and administrative expenses | |
| 3,044 | | |
| 1,220 | | |
| 1,824 | | |
| 150 | % |
Our
total selling, general and administrative expenses for the three-month period ended June 30, 2024, were $3.0 million as compared to $1.2
million for the same period in 2023, an increase of $1.8 million. This increase from the prior period is primarily due to the acquisition
of Aeterna.
(in thousands of US dollars, except percentages) | |
Six months ended June 30, | |
| |
2024 | | |
2023 | | |
Change | | |
Change | |
| |
$ | | |
$ | | |
$ | | |
% | |
Selling, general and administrative expenses: | |
| | | |
| | | |
| | | |
| | |
Salaries & benefits | |
| 855 | | |
| 980 | | |
| (125 | ) | |
| -13 | % |
Insurance | |
| 151 | | |
| 99 | | |
| 52 | | |
| 53 | % |
Professional fees | |
| 2,183 | | |
| 512 | | |
| 1,671 | | |
| 326 | % |
Other office & general expenses | |
| 1,521 | | |
| 761 | | |
| 760 | | |
| 100 | % |
Total selling, general and administrative expenses | |
| 4,710 | | |
| 2,352 | | |
| 2,358 | | |
| 100 | % |
Our
total selling, general and administrative expenses for the six-month period ended June 30, 2024, were $4.7 million as compared to $2.3
million for the same period in 2023, an increase of $2.4 million. This was primarily attributable to:
|
● |
An
increase in legal, professional fees of $1.7 million and other office & general expenses of $0.8 million, primarily due to the
acquisition of Aeterna as described in the plan of arrangement section above; offset by |
|
● |
A
decrease in salaries and benefits of $0.1 million due to a decrease in the number of full-time staff from the prior period. |
Other
income (costs)
For
the three-month period and six-month period ended June 30, 2024, our net other income was $1.9 million as compared to $19 thousand and
$24 thousand respectively for the same periods in the prior year, an increase of $1.9 million in both periods. This was primarily attributable
to the change in fair value of warrant and DSU liabilities in the amount of $1.8 million and higher interest income earned of $0.1 million.
Net
loss
For
the three-month period ended June 30, 2024, we reported a consolidated net loss of $1.4 million, or $0.64 loss per common share, as compared
with a consolidated net loss of $0.9 million, or $0.47 loss per common share for the same period in 2023. The $0.5 million increase in
net loss is attributable to:
|
● |
an
increase in research and development costs of $0.8 million due primarily to increase in costs associated with the avenanthramides
and DETECT clinical trials; and |
|
● |
an
increase in selling, general and administrative costs of $1.8 million due primarily to the acquisition of Aeterna; offset by |
|
● |
an
increase in other income of $1.9 million due to changes in the fair value of warrant and DSU liabilities; and |
|
● |
an
increase in income tax recovery of $0.3 million. |
For
the six-month period ended June 30, 2024, we reported a consolidated net loss of $2.8 million, or $1.39 loss per common share, as compared
with a consolidated net loss of $1.1 million, or $0.62 loss per common share for the same period in 2023. The $1.7 million increase in
net loss is attributable to:
|
● |
a
$0.4 million increase in revenues, that was offset by a $0.7 million increase in cost of sales due to an increase in sales volumes
and higher production costs; |
|
● |
an
increase in research and development costs of $1.5 million due primarily to increase in costs associated with the avenanthramides
and DETECT clinical trials; and |
|
● |
an
increase in selling, general and administrative of $2.4 million due primarily to the acquisition of Aeterna; offset by |
|
● |
an
increase in other income of $1.9 million due to changes in the fair value of warrant and DSU liabilities; and |
|
● |
An
increase in income tax recovery of $0.6 million; |
Selected
quarterly financial data
| |
Three months ended | |
(in thousands of US dollars, except for per share data) | |
June 30, 2024 | | |
March 31, 2024 | | |
December 31, 2023 | | |
September 30, 2023 | |
| |
$ | | |
$ | | |
$ | | |
$ | |
Revenues | |
| 2,337 | | |
| 2,057 | | |
| 1,213 | | |
| 1,952 | |
Net loss | |
| (1,422 | ) | |
| (1,401 | ) | |
| (1,565 | ) | |
| (776 | ) |
Net loss per share (basic and diluted) (1) | |
| (0.64 | ) | |
| (0.47 | ) | |
| (0.52 | ) | |
| (0.26 | ) |
| |
Three months ended | |
(in thousands of US dollars, except for per share data) | |
June 30, 2023 | | |
March 31,
2023 | | |
December 31, 2022 | | |
September 30,
2022 | |
| |
$ | | |
$ | | |
$ | | |
$ | |
Revenues | |
| 1,392 | | |
| 2,585 | | |
| 2,447 | | |
| 2,944 | |
Net (loss) / profit | |
| (1,339 | ) | |
| (285 | ) | |
| (170 | ) | |
| 774 | |
Net (loss) / profit per share (basic and diluted) (1) | |
| (0.47 | ) | |
| (0.09 | ) | |
| (0.06 | ) | |
| 0.26 | |
(1) |
Net
loss per share is based on the weighted average number of shares outstanding during each reporting period, which may differ on a
quarter-to-quarter basis. As such, the sum of the quarterly net loss per share amounts may not equal full-year net loss per share. |
Historical
quarterly results of operations and net loss cannot be taken as reflective of recurring revenue or expenditure patterns of
predictable trends, largely given the non-recurring nature of certain components of our revenues, unpredictable quarterly variations
in net finance income and of foreign exchange gains and losses. Historical quarterly sales and results primarily fluctuate due to
variations in the timing of customer orders, different product mixes, and changes in the optimal use of our capacity to manufacture
products.
Liquidity
and capital resources
The
Company’s objective in managing capital, consisting of shareholders’ equity, with cash and cash equivalents being its primary
components, is to ensure sufficient liquidity to fund research and development costs, production costs, selling expenses, general and
administrative expenses and working capital requirements. Over the past several years, we have raised capital via public and private
equity offerings and issuances and have entered licensing and collaborative arrangements, consideration
from which, together with proceeds from equity issuances, has been our primary source of liquidity. The capital management objective
of the Company remains the same as that in previous periods. The policy on dividends is to retain cash to keep funds available, to finance
the activities required to advance the Company’s product development portfolio and to pursue appropriate commercial opportunities
as they may arise. The Company is not subject to any capital requirements imposed by any regulators or by any other external source.
Cash
flows
The
following table shows a summary of our consolidated cash flows for the periods indicated:
(in thousands of US dollars) | |
Three months ended | | |
Six months ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
$ | | |
$ | | |
$ | | |
$ | |
Cash and cash equivalents – Beginning of period | |
| 3,506 | | |
| 9,295 | | |
| 6,678 | | |
| 10,190 | |
Net cash used in operating activities | |
| (1,389 | ) | |
| (813 | ) | |
| (3,790 | ) | |
| (1,642 | ) |
Net cash used in financing activities | |
| (126 | ) | |
| (70 | ) | |
| (198 | ) | |
| (133 | ) |
Net cash used in investing activities | |
| 25,880 | | |
| (54 | ) | |
| 25,316 | | |
| (85 | ) |
Effect of exchange rate changes on cash & cash equivalents | |
| (67 | ) | |
| 180 | | |
| (202 | ) | |
| 208 | |
Cash and cash equivalents – End of period | |
| 27,804 | | |
| 8,538 | | |
| 27,804 | | |
| 8,538 | |
Operating
Activities
Cash
used by operating activities was $1.4 million for the three-month period ended June 30, 2024, as compared to $0.8 million in the same
period in 2023. This $0.6 million increase in operating cash outflows is attributed primarily to:
|
● |
an
increase in research and development costs of $0.8 million due primarily to increase in costs associated with the avenanthramides
and DETECT clinical trials; and |
|
● |
an
increase in selling, general and administrative costs of $1.8 million due primarily to the acquisition of Aeterna; offset by |
|
● |
An increase in operating assets and liabilities of $2.0
million, primarily due to the acquisition of Aeterna. |
Cash
used by operating activities was $3.8 million for the six-month period ended June 30, 2024, as compared to $1.6 million in the same period
in 2023. This $2.2 million increase in operating cash outflows is attributed primarily to:
|
● |
A
decrease in gross margin of $0.3 million, primarily due to higher costs of sales during the period; |
|
● |
an
increase in research and development costs of $1.5 million due primarily to increase in costs associated with the avenanthramides
and DETECT clinical trials; and |
|
● |
an
increase in selling, general and administrative of $2.4 million due primarily to the acquisition of Aeterna; offset by |
|
● |
An increase in operating assets and liabilities of $2.0
million, primarily due to the acquisition of Aeterna. |
Investing
activities
Cash
provided by investing activities totaled $25.9 million for the three-month period ended June 30, 2024, as compared to $0.1 million in
the same period in 2023. This $25.8 million increase in investing cash inflows is attributed primarily to cash inflows associated with
the acquisition of Aeterna of $26.0 million offset by $0.2 million in purchases of property and equipment.
Capital
Stock
As
of August 9, 2024, we had 3,115,974 common shares issued and outstanding, as well as, 80,878 stock options, 114,230
deferred share units and 693,534 warrants outstanding. Each stock option, deferred share unit and warrant is exercisable for
one common share.
Adequacy
of financial resources
As
of June 30, 2024, the Company had retained earnings of $6.7 million, a net loss of $1.4 million and negative cash flows from operations
of $1.4 million for the three-month period ended June 30, 2024. We believe that our existing cash on hand will be sufficient to fund
our anticipated operating and capital expenditure requirements for at least the next 12 months. We plan to finance our future operations
and capital expenditures primarily through products sales and cash on hand. We also believe that our existing cash on hand will be sufficient
to fund our anticipated operating and capital expenditure requirements beyond the next 12 months and through 2025. We have based this
estimate on assumptions that may prove to be wrong, and we could exhaust our capital resources sooner than we expect. We may also require
additional capital to pursue in-licenses or acquisitions of other product candidates.
Our
forecast of the period through which our financial resources will be adequate to support our operations is a forward-looking statement
that involves risks and uncertainties, and actual results could vary materially as a result of a number of factors. Our future capital
requirements are difficult to forecast and will depend on many factors, including:
|
● |
the
terms and timing of any other collaboration, licensing, and other arrangements that we may establish; |
|
● |
the
initiation, progress, timing, and completion of preclinical studies and clinical trials for our current and future potential product
candidates, as well as other research and development programs; |
|
● |
our
alignment with the FDA on regulatory approval requirements; |
|
● |
the
number and characteristics of product candidates that we pursue; |
|
● |
the
outcome, timing, and cost of regulatory approvals; |
|
● |
delays
that may be caused by changing regulatory requirements; |
|
● |
the
cost and timing of hiring new employees to support our continued growth and potential expense associated with any loss of key personnel; |
|
● |
the
costs involved in filing and prosecuting patent applications and enforcing and defending patent claims; |
|
● |
the
costs of filing and prosecuting intellectual property rights and enforcing and defending any intellectual property-related claims; |
|
● |
the
costs associated with any potential late receipt or non-receipt of trade and other receivables; |
|
● |
the
potential costs associated with foreign currency fluctuations or changing interest rates; |
|
● |
our
ability to expand our customer base and related demand fluctuations; |
|
● |
the
costs associated with any potential interruption or quality impacts on raw material supplies; |
|
● |
the
costs of responding to and defending ourselves against complaints and potential litigation; |
|
● |
the
costs and timing of procuring clinical and commercial supplies for our product candidates; and |
|
● |
the
extent to which we acquire or in-license other product candidates and technologies. |
Contractual
obligations and commitments as of June 30, 2024
Significant
expenditure contracted for at the end of the reporting period but not recognized as liabilities is as follows:
(in thousands of US dollars) | |
TOTAL | |
| |
$ | |
Less than 1 year | |
| 4,352 | |
1 - 5 years | |
| 54 | |
| |
| 4,406 | |
The
Company executed various agreements including in-licensing and similar arrangements with development partners. Such agreements may require
the Company to make payments on achievement of stages of development, launch or revenue milestones, although the Company generally has
the right to terminate these agreements at no penalty. The Company may have to pay up to $38,573 upon achieving certain sales volumes,
regulatory or other milestones related to specific products.
Contingencies
In
the normal course of operations, the Company may become involved in various claims and legal proceedings related to, for example, contract
terminations and employee-related and other matters.
Critical
Accounting Policies, Estimates and Judgments
The
preparation of condensed interim consolidated financial statements in accordance with IFRS requires management to make judgements, estimates
and assumptions about the future that affect the reported amounts of the Company’s assets, liabilities, revenues, expenses and
related disclosures. Judgements, estimates and assumptions are based on historical experience, expectations, current trends and other
factors that management believes to be relevant at the time at which the Company’s condensed interim consolidated financial statements
are prepared.
Management
reviews, on a regular basis, the Company’s accounting policies, assumptions, estimates and judgements in order to ensure that the
condensed interim consolidated financial statements are presented fairly and in accordance with IFRS applicable to interim financial
statements. Revisions to estimates are recognized prospectively. Critical accounting estimates and assumptions, as well as critical judgements
used in applying accounting policies in the preparation of the Company’s condensed interim consolidated financial statements, were
the same as those applied to Ceapro’s annual consolidated financial statements as of and for the year ended December 31, 2023,
except for as described below:
|
● |
Measurement
of defined benefit obligations: key actuarial assumptions; and |
|
● |
Business
acquisition: identification of the acquirer, determination of the fair value of the consideration transferred and fair value of some
of the assets acquired and liabilities assumed. |
Financial
Risk Factors and Other Financial Instruments
The
nature and extent of our exposure to risks arising from financial instruments, including credit risk, liquidity risk and market risk
and how we manage those risks are described in note 15 to the Ceapro’s audited consolidated financial statements for the year ended
December 31, 2023.
Related
Party Transactions
Other
than employment agreements and indemnification agreements with our management, there are no related party transactions.
Off-Balance
Sheet Arrangements
As
of June 30, 2024, we did not have any interests in special purpose entities or any other off-balance sheet arrangements.
Risk
Factors and Uncertainties
An
investment in our securities involves a high degree of risk. In addition to the other information included in this MD&A and in the
related consolidated financial statements, investors are urged to carefully consider the risks described under the heading “Risk
Factors” in our most recent Annual Report on Form 20-F for the year ended December 31, 2023 and under the heading “Risks
and Uncertainties” in Exhibit 99.2 of our Form 6-K furnished to the SEC on May 14, 2024, for a discussion of the various risks
that may materially affect our business. The risks and uncertainties not presently known to us or that we currently deem immaterial may
also materially harm our business, operating results and financial condition and could result in a complete loss of your investment.
Our
most recent Annual Report on Form 20-F and Exhibit 99.2 of our Form 6-K furnished to the SEC on May 14, 2024 were filed with the relevant
Canadian and U.S. securities’ regulatory authorities at www.sedarplus.ca and with the SEC at www.sec.gov. Investors are urged to
consult the risk factors in these documents.
Disclosure
Controls and Procedures
The
Chief Executive Officer and the Chief Financial Officer of the Corporation are responsible for establishing and maintaining our disclosure
controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act and Canadian securities legislation).
Our disclosure controls and procedures are designed to ensure that information required to be disclosed in the reports we file or submit
under U.S. and Canadian securities legislation is recorded, processed, summarized and reported within the time periods specified in the
Securities and Exchange Commission’s rules and forms, and that such information required to be disclosed by us in
the reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including the Chief Executive
Officer and the Chief Financial Officer, to allow timely decisions regarding required disclosures.
Any
controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control
objective and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
There have been no significant changes to our disclosure controls and procedures for the three-month period ended June 30, 2024, that
have materially affected, or are reasonably likely to materially affect, the disclosure controls and procedures.
Internal
Controls over Financial Reporting
Our
management is responsible for establishing and maintaining adequate internal control over financial reporting (as such term is defined
in Rules 13a-15(f) and 15d-15(f) of the Exchange Act and Canadian securities legislation). Our internal control over financial reporting
is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial
statements for external purposes in accordance with IFRS as issued by the IASB.
Our
internal control over financial reporting includes those policies and procedures that: (i) pertain to the maintenance of records that,
in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of Aeterna Zentaris; (ii) provide
reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with IFRS
as issued by the IASB, and that receipts and expenditures of the Company are being made only in accordance with authorizations of management
and directors of the issuer; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition,
use or disposition of Company assets that could have a material effect on the financial statements.
Because
of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of
any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions,
or that the degree of compliance with the policies or procedures may deteriorate.
Changes
in Internal Controls over Financial Reporting
On
June 3, 2024, we completed the business combination transaction with Ceapro, which was accounted for a reverse acquisition. We are currently
in the process of integrating Ceapro’s internal controls over financial reporting. Other than with respect to the Ceapro business
combination, there have been no significant changes to our internal controls over financial reporting for the three-month period ended
June 30, 2024, that have materially affected, or are reasonably likely to materially affect, internal controls over financial reporting.
Exhibit 99.3
FORM
52-109F2
CERTIFICATION
OF INTERIM FILINGS
FULL
CERTIFICATE
I,
Gilles Gagnon, Chief Executive Officer, COSCIENS Biopharma Inc., certify the following:
1. | Review:
I have reviewed the interim financial report and interim MD&A (together, the
“interim filings”) of COSCIENS Biopharma Inc. (the “issuer”) for
the interim period ended June 30, 2024. |
2. | No
misrepresentations: Based on my knowledge, having exercised reasonable diligence,
the interim filings do not contain any untrue statement of a material fact or omit to state
a material fact required to be stated or that is necessary to make a statement not misleading
in light of the circumstances under which it was made, with respect to the period covered
by the interim filings. |
3. | Fair
presentation: Based on my knowledge, having exercised reasonable diligence, the interim
financial report together with the other financial information included in the interim filings
fairly present in all material respects the financial condition, financial performance and
cash flows of the issuer, as of the date of and for the periods presented in the interim
filings. |
4. | Responsibility:
The issuer’s other certifying officer(s) and I are responsible for establishing
and maintaining disclosure controls and procedures (DC&P) and internal control over financial
reporting (ICFR), as those terms are defined in National Instrument 52-109 Certification
of Disclosure in Issuers’ Annual and Interim Filings, for the issuer. |
5. | Design:
Subject to the limitations, if any, described in paragraphs 5.2 and 5.3, the issuer’s
other certifying officer(s) and I have, as at the end of the period covered by the interim
filings |
| (a) | designed
DC&P, or caused it to be designed under our supervision, to provide reasonable assurance
that |
| (i) | material
information relating to the issuer is made known to us by others, particularly during the
period in which the interim filings are being prepared; and |
| (ii) | information
required to be disclosed by the issuer in its annual filings, interim filings or other reports
filed or submitted by it under securities legislation is recorded, processed, summarized
and reported within the time periods specified in securities legislation; and |
| (b) | designed
ICFR, or caused it to be designed under our supervision, to provide reasonable assurance
regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with the issuer’s GAAP. |
5.1 | Control
framework: The control framework the issuer’s other certifying officer(s) and
I used to design the issuer’s ICFR is Internal Control – Integrated Framework:
2013, issued by the Committee of Sponsoring Organizations of the Treadway Commission. |
6. | Reporting
changes in ICFR: The issuer has disclosed in its interim MD&A any change in the
issuer’s ICFR that occurred during the period beginning on April 1, 2024 and ended
on June 30, 2024 that has materially affected, or is reasonably likely to materially affect,
the issuer’s ICFR. |
Date:
August 13th, 2024
/s/
Gilles Gagnon |
|
Gilles
Gagnon |
|
Chief
Executive Officer |
|
Exhibit
99.4
FORM
52-109F2
CERTIFICATION
OF INTERIM FILINGS
FULL
CERTIFICATE
I,
Giuliano La Fratta, Chief Financial Officer, COSCIENS Biopharma Inc., certify the following:
1. | Review:
I have reviewed the interim financial report and interim MD&A (together, the
“interim filings”) of COSCIENS Biopharma Inc. (the “issuer”) for
the interim period ended June 30, 2024. |
2. | No
misrepresentations: Based on my knowledge, having exercised reasonable diligence,
the interim filings do not contain any untrue statement of a material fact or omit to state
a material fact required to be stated or that is necessary to make a statement not misleading
in light of the circumstances under which it was made, with respect to the period covered
by the interim filings. |
3. | Fair
presentation: Based on my knowledge, having exercised reasonable diligence, the interim
financial report together with the other financial information included in the interim filings
fairly present in all material respects the financial condition, financial performance and
cash flows of the issuer, as of the date of and for the periods presented in the interim
filings. |
4. | Responsibility:
The issuer’s other certifying officer(s) and I are responsible for establishing
and maintaining disclosure controls and procedures (DC&P) and internal control over financial
reporting (ICFR), as those terms are defined in National Instrument 52-109 Certification
of Disclosure in Issuers’ Annual and Interim Filings, for the issuer. |
5. | Design:
Subject to the limitations, if any, described in paragraphs 5.2 and 5.3, the issuer’s
other certifying officer(s) and I have, as at the end of the period covered by the interim
filings |
| (a) | designed
DC&P, or caused it to be designed under our supervision, to provide reasonable assurance
that |
| (i) | material
information relating to the issuer is made known to us by others, particularly during the
period in which the interim filings are being prepared; and |
| (ii) | information
required to be disclosed by the issuer in its annual filings, interim filings or other reports
filed or submitted by it under securities legislation is recorded, processed, summarized
and reported within the time periods specified in securities legislation; and |
| (b) | designed
ICFR, or caused it to be designed under our supervision, to provide reasonable assurance
regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with the issuer’s GAAP. |
5.1 | Control
framework: The control framework the issuer’s other certifying officer(s) and
I used to design the issuer’s ICFR is Internal Control – Integrated Framework:
2013, issued by the Committee of Sponsoring Organizations of the Treadway Commission. |
6. | Reporting
changes in ICFR: The issuer has disclosed in its interim MD&A any change in the
issuer’s ICFR that occurred during the period beginning on April 1, 2024 and ended
on June 30, 2024 that has materially affected, or is reasonably likely to materially affect,
the issuer’s ICFR. |
Date:
August 13th, 2024
/s/
Giuliano La Fratta |
|
Giuliano
La Fratta |
|
Chief
Financial Officer |
|
v3.24.2.u1
Cover
|
6 Months Ended |
Jun. 30, 2024 |
Cover [Abstract] |
|
Document Type |
6-K
|
Amendment Flag |
false
|
Document Period End Date |
Jun. 30, 2024
|
Document Fiscal Period Focus |
Q2
|
Document Fiscal Year Focus |
2024
|
Current Fiscal Year End Date |
--12-31
|
Entity File Number |
001-38064
|
Entity Registrant Name |
COSCIENS
Biopharma Inc.
|
Entity Central Index Key |
0001113423
|
Entity Address, Address Line One |
c/o
Norton Rose Fulbright Canada, LLP,
|
Entity Address, Address Line Two |
222 Bay Street,
|
Entity Address, Address Line Three |
Suite 3000, PO Box 53
|
Entity Address, City or Town |
Toronto
|
Entity Address, State or Province |
ON
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M5K
1E7
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v3.24.2.u1
Condensed Interim Consolidated Statements of Financial Position (Unaudited) - USD ($) $ in Thousands |
Jun. 30, 2024 |
Dec. 31, 2023 |
Current assets |
|
|
Cash and cash equivalents |
$ 27,804
|
$ 6,678
|
Trade and other receivables |
1,238
|
290
|
Inventories (note 5) |
3,055
|
4,009
|
Income taxes receivable |
117
|
|
Prepaid expenses and other assets (note 6) |
994
|
290
|
Total current assets |
33,208
|
11,267
|
Non-current assets |
|
|
Restricted cash and cash equivalents |
332
|
8
|
Investment tax credit receivable |
719
|
743
|
Property and equipment (note 7) |
11,499
|
11,645
|
Intangible assets (note 8) |
3,335
|
7
|
Deferred tax assets |
952
|
75
|
Total non-current assets |
16,837
|
12,478
|
Total assets |
50,045
|
23,745
|
Current liabilities |
|
|
Payables and accrued liabilities (note 9) |
5,841
|
1,012
|
Provisions |
432
|
|
Income taxes payable |
108
|
|
Current portion of deferred revenues (note 4) |
97
|
|
Current portion of lease liabilities |
407
|
299
|
Warrant liability (note 11) |
2,796
|
|
DSU liability (note 12) |
217
|
|
Total current liabilities |
9,898
|
1,311
|
Non-current liabilities |
|
|
Deferred revenues (note 4) |
1,613
|
|
Lease liabilities |
1,280
|
1,399
|
Employee future benefits (note 10) |
11,027
|
|
Total non-current liabilities |
13,920
|
1,399
|
Total liabilities |
23,818
|
2,710
|
Shareholders’ equity |
|
|
Share capital (note 13) |
22,002
|
13,517
|
Contributed surplus |
3,910
|
3,874
|
Retained earnings |
1,533
|
4,356
|
Accumulated other comprehensive loss |
(1,218)
|
(712)
|
Total Shareholders’ equity |
26,227
|
21,035
|
Total liabilities and shareholders’ equity |
$ 50,045
|
$ 23,745
|
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v3.24.2.u1
Condensed Interim Consolidated Statements of Changes in Shareholders' Equity (Unaudited) - USD ($) $ in Thousands |
Issued capital [member] |
Contributed surplus [member] |
Retained earnings [member] |
Accumulated other comprehensive income [member] |
Total |
Balance at Dec. 31, 2022 |
$ 13,496
|
$ 3,690
|
$ 7,841
|
$ (1,204)
|
$ 23,823
|
IfrsStatementLineItems [Line Items] |
|
|
|
|
|
Net loss |
|
|
(1,145)
|
|
(1,145)
|
Foreign currency translation adjustments |
|
|
|
546
|
546
|
Comprehensive income |
|
|
(1,145)
|
546
|
(599)
|
Share-based compensation costs |
|
143
|
|
|
143
|
Options exercised |
2
|
(1)
|
|
|
1
|
Balance at Jun. 30, 2023 |
13,498
|
3,832
|
6,696
|
(658)
|
23,368
|
Balance at Dec. 31, 2023 |
13,517
|
3,874
|
4,356
|
(712)
|
21,035
|
IfrsStatementLineItems [Line Items] |
|
|
|
|
|
Net loss |
|
|
(2,823)
|
|
(2,823)
|
Foreign currency translation adjustments |
|
|
|
(506)
|
(506)
|
Comprehensive income |
|
|
(2,823)
|
(506)
|
(3,329)
|
Acquisition of Aeterna Zentaris Inc. (note 3) |
8,485
|
9
|
|
|
8,494
|
Share-based compensation costs |
|
27
|
|
|
27
|
Balance at Jun. 30, 2024 |
$ 22,002
|
$ 3,910
|
$ 1,533
|
$ (1,218)
|
$ 26,227
|
X |
- DefinitionAcquisition of Aeterna Zentaris Inc.
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v3.24.2.u1
Condensed Interim Consolidated Statements of Loss and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Profit or loss [abstract] |
|
|
|
|
Revenues (note 4) |
$ 2,337
|
$ 1,392
|
$ 4,394
|
$ 3,977
|
Cost of sales |
(1,518)
|
(595)
|
(2,671)
|
(1,992)
|
Gross profit |
819
|
797
|
1,723
|
1,985
|
Research and development |
(1,530)
|
(691)
|
(2,592)
|
(1,115)
|
Selling, general and administrative |
(3,044)
|
(1,220)
|
(4,710)
|
(2,352)
|
Loss from operations |
(3,755)
|
(1,114)
|
(5,579)
|
(1,482)
|
Gain due to changes in foreign currency |
17
|
|
42
|
|
Finance costs |
(22)
|
(24)
|
(85)
|
(90)
|
Other income |
109
|
43
|
158
|
114
|
Change in fair value of warrant and DSU liabilities |
1,755
|
|
1,755
|
|
Other income |
1,859
|
19
|
1,870
|
24
|
Loss before income taxes |
(1,896)
|
(1,095)
|
(3,709)
|
(1,458)
|
Income tax recovery |
474
|
235
|
886
|
313
|
Net loss |
(1,422)
|
(860)
|
(2,823)
|
(1,145)
|
Items that may be reclassified subsequently to profit or loss: |
|
|
|
|
Foreign currency translation adjustments |
(47)
|
479
|
(506)
|
546
|
Comprehensive loss |
$ (1,469)
|
$ (381)
|
$ (3,329)
|
$ (599)
|
Basic loss per share |
$ (0.64)
|
$ (0.47)
|
$ (1.39)
|
$ (0.62)
|
Diluted loss per share |
$ (0.64)
|
$ (0.47)
|
$ (1.39)
|
$ (0.62)
|
Weighted average number of shares outstanding (basic) |
2,220,303
|
1,846,775
|
2,033,539
|
1,846,759
|
Weighted average number of shares outstanding (diluted) |
2,220,303
|
1,846,775
|
2,033,539
|
1,846,759
|
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v3.24.2.u1
Condensed Interim Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Cash flows from operating activities |
|
|
|
|
Net loss for the period |
$ (1,422)
|
$ (860)
|
$ (2,823)
|
$ (1,145)
|
Items not affecting cash and cash equivalents: |
|
|
|
|
Depreciation and amortization |
377
|
362
|
736
|
721
|
Share-based compensation costs |
13
|
43
|
27
|
142
|
Employee future benefits |
43
|
|
43
|
|
Change in fair value of warrant and DSU liabilities |
(1,755)
|
|
(1,755)
|
|
Other non-cash items |
11
|
|
11
|
|
Income tax recovery |
(474)
|
(235)
|
(886)
|
(313)
|
Changes in operating assets and liabilities (note 15) |
1,818
|
(123)
|
857
|
(1,047)
|
Net cash used in operating activities |
(1,389)
|
(813)
|
(3,790)
|
(1,642)
|
Cash flows from financing activities |
|
|
|
|
Exercise of stock options |
|
|
|
1
|
Payments on lease liabilities |
(126)
|
(70)
|
(198)
|
(134)
|
Net cash used in financing activities |
(126)
|
(70)
|
(198)
|
(133)
|
Cash flows from investing activities |
|
|
|
|
Acquisition of Aeterna Zentaris Inc. (note 3) |
26,037
|
|
26,037
|
|
Purchase of property and equipment |
(157)
|
(54)
|
(721)
|
(85)
|
Net cash used in investing activities |
25,880
|
(54)
|
25,316
|
(85)
|
Effect of exchange rate changes on cash and cash equivalents |
(67)
|
180
|
(202)
|
208
|
Net change in cash and cash equivalents |
24,298
|
(757)
|
21,126
|
(1,652)
|
Cash and cash equivalents – Beginning of period |
3,506
|
9,295
|
6,678
|
10,190
|
Cash and cash equivalents – End of period |
$ 27,804
|
$ 8,538
|
$ 27,804
|
$ 8,538
|
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v3.24.2.u1
Business overview
|
6 Months Ended |
Jun. 30, 2024 |
Notes and other explanatory information [abstract] |
|
Business overview |
1. Business overview
Summary
of business
COSCIENS
Biopharma Inc. (the “Company”), formerly Aeterna Zentaris Inc., is a specialty biopharmaceutical company developing and commercializing
a diversified portfolio of cosmeceutical, nutraceutical and pharmaceutical products. The Company’s patented technologies include
Pressurized Gas eXpanded (PGX) technology that generates high-value yields of active ingredients from natural plant resources for use
in novel cosmeceutical, nutraceutical and therapeutics products. The Company’s two value-driving active ingredient products, oat
beta glucan and avenanthramides, are found in many household name cosmetic and personal care brands. These products are manufactured
from the Company’s proprietary oat extraction manufacturing technology and are known for their health benefits.
The
Company’s lead pharmaceutical product, macimorelin (Macrilen; Ghryvelin), is the first and only U.S. FDA and European Commission
approved oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD). The Company is leveraging the clinical success
and safety profile of macimorelin to develop it for the diagnosis of childhood-onset growth hormone deficiency (CGHD).
The
Company is also dedicated to the development of its therapeutic assets and has established a pre-clinical development pipeline to potentially
address unmet medical needs across a number of indications, including treatment of inflammation-based diseases, idiopathic pulmonary
fibrosis (IPF), neuromyelitis optica spectrum disorder (NMOSD), Parkinson’s disease (PD), hypoparathyroidism and amyotrophic lateral
sclerosis (ALS; Lou Gehrig’s disease).
Transaction
On
December 14, 2023, Aeterna Zentaris Inc. (“Aeterna”) and Ceapro Inc. (“Ceapro”) entered into a binding arrangement
agreement pursuant to which Aeterna would acquire all of the issued and outstanding common shares of Ceapro (the “Transaction”)
by way of a plan of arrangement pursuant to which, at closing, each outstanding Ceapro common share would be exchanged for 0.02360 of
a Aeterna common share (the “Plan of Arrangement”). Additionally, as part of the Transaction, Aeterna would issue to its
shareholders immediately prior to the closing of the Transaction, 0.47698 of a share purchase warrant (“New Warrant”) for
each Aeterna common share or warrant held. On March 12, 2024, the shareholders of both Ceapro and Aeterna approved the Plan of Arrangement
at their respective special meetings. On March 28, 2024, the Court of Kings Bench of Alberta approved the Plan of Arrangement. The Transaction
was consummated on June 3, 2024.
Following
the closing of the Transaction, former shareholders of Ceapro owned approximately 50% of the Aeterna common shares on a fully diluted
basis and former shareholders of Aeterna owned approximately 50% of the Aeterna common shares on a fully diluted basis. For financial
reporting and accounting purposes, Ceapro is the acquirer of Aeterna in the Transaction. The consolidated financial statements of COSCIENS
Biopharma Inc. as of June 30, 2024 and December 31, 2023 and for the three and six months ended June 30, 2024 and 2023 reflect the results
of operations and financial position of Ceapro for the periods presented and includes 28 days of the results of operations of Aeterna
as of June 30, 2024 and for three and six months ended June 30, 2024 subsequent to the Transaction, which was completed on June 3, 2024.
Refer to Note 3 for additional information.
The
accompanying consolidated financial statements include the accounts of COSCIENS Biopharma Inc., an entity incorporated under the Canada
Business Corporations Act, and its wholly owned subsidiaries (the “Group”). COSCIENS Biopharma Inc. is the ultimate parent
company of the Group. The Company currently has six wholly-owned direct and indirect subsidiaries, Ceapro Inc. and its wholly-owned subsidiaries
Ceapro (P.E.I.) and JuventeDC Inc., based in Canada, Aeterna Zentaris GmbH (“AEZS Germany”) and its wholly-owned
subsidiary Zentaris IVF GmbH, based in Frankfurt, Germany, and Aeterna Zentaris, Inc., an entity incorporated in the state of Delaware
and with offices in Summerville, South Carolina, in the US.
COSCIENS
Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
The
registered office of the Company is located at 222 Bay Street, Suite 3000, P.O. Box 53, Toronto, Ontario M5K 1E7, Canada.
The
Company’s common shares are listed on both the Toronto Stock Exchange under the symbol CSCI (previously AEZS) and on the NASDAQ
Capital Market under the symbol CSCI (previously AEZS).
|
X |
- DefinitionThe disclosure of the basis used for the preparation of the financial statements.
+ ReferencesReference 1: http://www.xbrl.org/2009/role/commonPracticeRef -Name IAS -Number 1 -IssueDate 2023-01-01 -Paragraph 10 -Subparagraph e -URI https://taxonomy.ifrs.org/xifrs-link?type=IAS&num=1&code=ifrs-tx-2023-en-r&anchor=para_10_e&doctype=Standard -URIDate 2023-03-23
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v3.24.2.u1
Basis of presentation
|
6 Months Ended |
Jun. 30, 2024 |
Notes and other explanatory information [abstract] |
|
Basis of presentation |
2. Basis of presentation
These
unaudited condensed interim consolidated financial statements have been prepared in accordance with IAS 34, Interim Financial Reporting
as issued by the International Accounting Standards Board.
The
unaudited condensed interim consolidated financial statements do not include all the notes normally included in annual consolidated financial
statements. The unaudited condensed interim consolidated financial statements reflect all normal and reoccurring adjustments that are,
in the opinion of management, necessary for a fair presentation of the results for the interim periods presented. Accordingly, these
unaudited condensed interim consolidated financial statements should be read in conjunction with the Ceapro’s annual consolidated
financial statements as of and for the year ended December 31, 2023.
The
accounting policies used in these condensed interim consolidated financial statements are consistent with those presented in Ceapro’s
annual consolidated financial statements, except for the accounting policies as described below:
Business
combinations
Business
combinations are accounted for using the acquisition method as at the acquisition date when control is transferred. The consideration
transferred for the acquisition of a business is the fair value of the assets transferred, and any liability and equity interests issued
by the Company to the former owners of the acquired business on the acquisition date. Identifiable assets acquired and liabilities assumed
in a business combination are generally measured initially at their fair values at the acquisition date. Acquisition-related costs other
than those associated with the issue of debt or equity securities, and other direct costs of a business combination are not considered
part of the business acquisition transaction and are expensed as incurred.
Foreign
currency
Effective
June 30, 2024, Ceapro has changed its reporting currency from Canadian dollars to U.S. dollars. This change in reporting currency has
been applied retrospectively such that all amounts in the consolidated financial statements of the Company and the accompanying notes
thereto are expressed in U.S. dollars. References to “$” are U.S. dollars and references to “CA $” are to Canadian
dollars. For comparative purposes, historical consolidated financial statements of Ceapro were recast in U.S. dollars by translating
assets and liabilities at the closing exchange rate in effect at the end of the respective period, revenues, expenses and cash flows
at the average exchange rate in effect for the respective period and equity transactions at historical exchange rates. Translation gains
and losses are included in the cumulative foreign currency translation adjustment, which is reported as a component of shareholders’
equity under accumulated other comprehensive loss.
COSCIENS
Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
Post-employment
benefits
The
Company has partially funded and unfunded defined benefit multi-employer pension plans, namely the DUPK pension plan and the RUK 1990
and 2006 pension plans, (the “Pension Benefit Plans”) and unfunded post-employment benefit plans in Germany. Provisions for
pension obligations are established for benefits payable in the form of retirement, disability and surviving dependent pensions. The
Company also provides defined contribution plans to some of its employees.
For
defined benefit pension plans and other post-employment benefits, net periodic pension expense is actuarially determined on a quarterly
basis using the projected unit credit method. The cost of pension and other benefits earned by employees is determined by applying certain
assumptions, including discount rates, rate of pension benefit increases, the projected age of employees upon retirement and the expected
rate of future compensation.
The
employee future benefits liability is recognized at its present value, which is determined by discounting the estimated future cash outflows
using interest rates of high-quality corporate bonds that are denominated in the currency in which the benefits will be paid and that
have terms to maturity approximating the terms of the related future benefit liability. Actuarial gains and losses that arise in calculating
the present value of the defined benefit obligation are recognized in other comprehensive loss, net of tax, and simultaneously reclassified
in the deficit in the consolidated statement of financial position in the year in which the actuarial gains and losses arise and without
recycling to the consolidated statement of loss and comprehensive loss in subsequent periods.
Revenue
The
Company generates revenue from supply agreements and licensing agreements with customers for the sale of certain finished goods, semi-finished
goods and active pharmaceutical ingredients. The license is generally combined with other promises to supply goods to the customer, and
revenue from the combined performance obligation is satisfied at a point in time, which occurs upon shipment. The transaction price for
the combined performance obligation includes the license non-refundable non-creditable upfront payment, regulatory milestones, royalties
and the selling price of each good supplied. Milestone payments, which are oftentimes payable upon the successful achievement of development
or regulatory events, and royalties are included in the transaction price using the most likely amount method only if the milestones
are considered probable of being reached and the Company concludes it is highly probable that a significant revenue reversal will not
occur. Milestone payments and royalties that are not within the control of the Company or the licensee, such as regulatory approvals,
are generally not considered probable of being achieved until those approvals or subsequent sales are received. The Company allocates
the transaction price to the projected units that the Company expects to supply pursuant to the contract, estimated based on current
projections and anticipated market demand.
Intangible
assets
Intangible
assets, consisting of patents, that are acquired by the Company and have finite useful lives are measured at cost less accumulated amortization
and any accumulated impairment losses. Patents are amortized on their respective remaining patent life and are expiring between 2027
and 2041.
Warrant
liabilities
Warrant
liabilities are derivative financial instruments. They are initially measured at fair value. Subsequent to initial recognition, they
are measured at fair value, and changes therein are recognised in profit or loss.
COSCIENS
Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
Reclassifications
Certain
prior period amounts have been reclassified to conform to current period presentation. In the consolidated statement of financial position,
trade receivables of $126 and other receivable of $164 were classified to trade and other receivables. In the consolidated statements
of loss for the six months ended June 30, 2023, the general and administration expenses of $2,336 (for the three months ended June 30,
2023 - $1,210) and the sales and marketing expenses of $16 (for the three months ended June 30, 2023 - $10) were reclassified within
Selling, general and administrative expenses.
New
standards and amendments
Several
amendments apply for the first time for reporting periods beginning after January 1, 2024, but do not have an impact on the interim condensed
consolidated financial statements of the Company. The IASB has published several new, but not yet effective, standards, amendments to
existing standards, and interpretations. None of these standards, amendments to existing standards, or interpretations have been early
adopted by the Company, and management anticipates that all relevant pronouncements will be adopted for the first period beginning on
or after the effective date of the pronouncement. No pronouncements have been disclosed as they are not expected to have a material impact
on the Company’s condensed interim consolidated financial statements.
Critical
accounting estimates and judgements
The
preparation of condensed interim consolidated financial statements in accordance with IFRS requires management to make judgements, estimates
and assumptions about the future that affect the reported amounts of the Company’s assets, liabilities, revenues, expenses and
related disclosures. Judgements, estimates and assumptions are based on historical experience, expectations, current trends and other
factors that management believes to be relevant at the time at which the Company’s condensed interim consolidated financial statements
are prepared.
Management
reviews, on a regular basis, the Company’s accounting policies, assumptions, estimates and judgements in order to ensure that the
condensed interim consolidated financial statements are presented fairly and in accordance with IFRS applicable to interim financial
statements. Revisions to estimates are recognized prospectively. Critical accounting estimates and assumptions, as well as critical judgements
used in applying accounting policies in the preparation of the Company’s condensed interim consolidated financial statements, were
the same as those applied to Ceapro’s annual consolidated financial statements as of and for the year ended December 31, 2023,
except for as described below:
|
● |
Measurement
of defined benefit obligations: key actuarial assumptions (note 10); and |
|
● |
Business
acquisition: identification of the acquirer, determination of the fair value of the consideration transferred and fair value of some
of the assets acquired and liabilities assumed (note 3). |
|
X |
- DefinitionThe disclosure of the basis used for consolidation.
+ ReferencesReference 1: http://www.xbrl.org/2009/role/commonPracticeRef -Name IAS -Number 1 -IssueDate 2023-01-01 -Paragraph 10 -Subparagraph e -URI https://taxonomy.ifrs.org/xifrs-link?type=IAS&num=1&code=ifrs-tx-2023-en-r&anchor=para_10_e&doctype=Standard -URIDate 2023-03-23
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v3.24.2.u1
Acquisition of Aeterna Zentaris Inc.
|
6 Months Ended |
Jun. 30, 2024 |
Notes and other explanatory information [abstract] |
|
Acquisition of Aeterna Zentaris Inc. |
3. Acquisition of Aeterna Zentaris Inc.
As
discussed in Note 1, Business Overview, as a result of the Transaction, Ceapro acquired control of Aeterna Zentaris Inc. on June 3, 2024.
Aeterna is a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests. Aeterna’s lead
product, Macrilen® (macimorelin), is the first and only U.S. FDA and EMA approved oral test indicated for the diagnosis of patients
with adult growth hormone deficiency (“AGHD”). Macimorelin is currently marketed under the tradename Ghryvelin™ in
the European Economic Area and the United Kingdom through an exclusive licensing agreement with Pharmanovia. Aeterna is actively pursuing
business development opportunities for the commercialization of macimorelin in North America, Asia and the rest of the world. Aeterna
is also dedicated to the development of therapeutic assets and has taken steps to establish a pre-clinical pipeline to potentially address
unmet medical needs across several indications with a focus on rare or orphan indications.
COSCIENS
Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
The
Transaction was accounted for as a reverse acquisition under the acquisition method of accounting for business combinations. Ceapro was
considered to be the accounting acquirer, and Aeterna was considered the legal acquirer. The amounts recorded for certain assets and
liabilities are preliminary in nature and are subject to adjustment as additional information is obtained about the facts and circumstances
that existed as of the acquisition date. The final determination of the fair values of certain assets and liabilities will be completed
within the measurement period of up to one year from the acquisition date. Under the acquisition method of accounting, total consideration
exchanged and allocation of the purchase price to the fair values of assets acquired and liabilities assumed in the Transaction were
as follows:
Schedule
of purchase price to the fair values of assets acquired and liabilities assumed
Preliminary
Purchase Price Allocation
| |
| | | |
| | |
| |
Number | | |
Amount | |
| |
# | | |
$ | |
Purchase
price | |
| | | |
| | |
Shares deemed
issued to Aeterna shareholders(1) | |
| | |
| 8,485 | |
Warrants issued to Aeterna
shareholders(2) | |
| 633,543 | | |
| 4,422 | |
Replacement share-based
payment awards: | |
| | | |
| | |
Equity-settled options(3) | |
| 12,949 | | |
| 9 | |
Cash-settled DSUs(3) | |
| 49,230 | | |
| 344 | |
Warrants
deemed issued(4) | |
| 114,405 | | |
| 2 | |
| |
| 2,024,094 | | |
| 13,262 | |
| |
| | | |
| | |
Recognized
amounts of identifiable assets acquired and liabilities assumed | |
| | | |
| | |
Cash and cash equivalents | |
| | | |
| 26,037 | |
Trade and other receivables | |
| | | |
| 142 | |
Inventories | |
| | | |
| 64 | |
Income tax receivables | |
| | | |
| 119 | |
Prepaid expenses and deposits | |
| | | |
| 971 | |
Restricted cash equivalents | |
| | | |
| 328 | |
Property and equipment | |
| | | |
| 235 | |
Intangible assets(5) | |
| | | |
| 3,352 | |
Accounts payable and accrued
liabilities | |
| | | |
| (4,357 | ) |
Provisions | |
| | | |
| (424 | ) |
Income tax payable | |
| | | |
| (109 | ) |
Deferred revenues | |
| | | |
| (1,731 | ) |
Lease liabilities | |
| | | |
| (201 | ) |
Employee future benefits | |
| | | |
| (11,164 | ) |
| |
| | | |
| | |
Total
provisional identifiable net assets (liabilities) | |
| | | |
| 13,262 | |
|
(1) |
The fair value of the 1,213,967
common shares deemed issued to Aeterna shareholders of $6.99 per share was based on the listed share price of Ceapro as at June 3,
2024 (CA$0.225), after giving effect to the exchange of each outstanding Ceapro common share for 0.02360 of a Aeterna common share
and the foreign currency exchange rate. |
(In
thousands of US dollars, except share and per share data and as otherwise noted)
|
(2) |
The fair value of the 633,543
New Warrants issued to Aeterna shareholders was based on the listed share price of Ceapro as at June 3, 2024 of $6.99 (CA$0.225) less
the exercise price of $0.01, after giving effect to the exchange of each outstanding Ceapro Common Share for 0.02360 of a Aeterna Zentaris
Common Share and the foreign currency exchange rate. |
|
(3) |
In accordance with the terms
of the Plan of Arrangement, Aeterna’s share-based payment awards held by employees of Aeterna continued with no modifications
and are deemed to be replacement awards issued. |
|
(4) |
The fair value of the 114,405
warrants deemed issued to Aeterna warrant holders was estimated using a Black-Scholes option pricing model, considering the terms and
conditions upon which the warrants were issued, using the following assumptions: |
|
(5) |
The identifiable intangible
assets consist of patents expiring between 2027 and 2041 which will be amortized on their respective remaining patent life. To estimate
the fair value of the intangible assets, management uses the royalty relief method to value patents using discounted cash flow models.
Management developed assumptions related to revenue and EBITDA margin forecasts, attrition rates, royalty rates and discount rates. |
The
fair value of the replacement awards is $356, after taking into account an estimated forfeiture rate of nil. The consideration for the
business combination includes $9 for equity-settled options and $344 for cash-settled DSUs transferred to employees of Aeterna when the
acquiree’s awards were substituted by the replacement awards, which relates to past service. The balance of $3 will be recognized
as post-acquisition compensation cost.
The
fair value at acquisition date was estimated using a Black-Scholes option pricing model, considering the terms and conditions upon which
the options were granted, using the following assumptions:
Schedule of fair value at acquisition date was estimated using a Black-Scholes option
| |
Options | |
Expected dividend
yield | |
$ | 0.0 | |
Weighted average expected volatility | |
| 65 | % |
Weighted average risk-free rate | |
| 4.01 | % |
Weighted average expected life (years) | |
| 2.87 | |
Share price | |
$ | 6.99 | |
Weighted average exercise price | |
$ | 50.15 | |
Weighted average fair value | |
$ | 0.90 | |
The
expected volatility of these options was determined using historical volatility rates and the expected life was determined using the
weighted average life of past options issued.
The
fair value of the replacement DSUs of $6.99 per DSU was based on the listed share price of Ceapro as at June 3, 2024 (CA$0.225), after
giving effect to the exchange of each outstanding Ceapro common share for 0.02360 of a Aeterna common share and the foreign currency
exchange rate.
|
(4) |
The fair value of the 114,405
warrants deemed issued to Aeterna warrant holders was estimated using a Black-Scholes option pricing model, considering the terms and
conditions upon which the warrants were issued, using the following assumptions: |
Schedule of fair value at acquisition date was estimated using a Black-Scholes option
| |
Warrants | |
Expected dividend
yield | |
$ | 0.00 | |
Weighted average expected volatility | |
| 65 | % |
Weighted average risk-free rate | |
| 4.47 | % |
Weighted average expected life (years) | |
| 1.19 | |
Share price | |
$ | 6.99 | |
Weighted average exercise price | |
$ | 87.04 | |
Weighted average fair value | |
$ | 0.02 | |
|
(5) |
The identifiable intangible
assets consist of patents expiring between 2027 and 2041 which will be amortized on their respective remaining patent life. To estimate
the fair value of the intangible assets, management uses the royalty relief method to value patents using discounted cash flow models.
Management developed assumptions related to revenue and EBITDA margin forecasts, attrition rates, royalty rates and discount rates. |
For
the period subsequent to the Transaction, Aeterna contributed revenue of $3 and net loss of $214 to the Company’s results. If the
acquisition had occurred on January 1, 2024, management estimates that revenue would have been $4,399 and consolidated net loss for the
year would have been $12,035. In determining these amounts, management has assumed that the fair value adjustments that arose on the
date of acquisition would have been the same if the acquisition had occurred on January 1, 2024.
COSCIENS
Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
The
Company incurred acquisition-related costs of $4,081 on legal fees and due diligence costs. These costs have been included in Selling,
general and administrative expenses as incurred.
|
X |
- DefinitionThe entire disclosure for business combinations.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/disclosureRef -Name IFRS -Number 3 -IssueDate 2023-01-01 -Section Disclosures -URI https://taxonomy.ifrs.org/xifrs-link?type=IFRS&num=3&code=ifrs-tx-2023-en-r&doctype=Standard&dita_xref=IFRS03_g59-63_TI -URIDate 2023-03-23
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v3.24.2.u1
Revenue
|
6 Months Ended |
Jun. 30, 2024 |
Notes and other explanatory information [abstract] |
|
Revenue |
4. Revenue
The
Company derives revenue from the transfer of goods at a point in time in the following categories:
Summary
of revenue from transfer of goods and services
| |
| | | |
| | | |
| | | |
| | |
| |
Three
months ended | | |
Six
months ended | |
| |
June
30, | | |
June
30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| $ | | |
| $ | | |
| $ | | |
| $ | |
Active ingredients | |
| 2,334 | | |
| 1,392 | | |
| 4,391 | | |
| 3,977 | |
Pharmaceutical | |
| 3 | | |
| - | | |
| 3 | | |
| - | |
Total | |
| 2,337 | | |
| 1,392 | | |
| 4,394 | | |
| 3,977 | |
Deferred
revenue
The
deferred revenue balance primarily relates to the advance consideration received in the form of non-refundable non-creditable upfront
payment and milestone payments relating to list price approvals of Ghryvelin™ in the United Kingdom, Spain and Germany as per an
exclusive licensing agreement for the commercialization of macimorelin (the “Licensed Product”) in the European Economic
Area and the United Kingdom and an exclusive supply agreement for a period of ten years, subject to renewal, to supply such Licensed
Product.
Revenue
for this contract will be recognized based on units of Licensed Product supplied. The total units that the Company expects to supply
pursuant to the Pharmanovia Agreement is an estimate, based on current projections and anticipated market demand, and therefore will
be a significant judgment that will be relied upon when using the outputs method to recognize revenue. The Company expects to recognize
the balance of the deferred revenue over the remaining period of eight years, subject to extension based on the outcome of the ongoing
clinical development related to the Pediatric Indication and related patent application initiatives. For the three months and six months
ended June 30, 2024, the Company recognized $nil and $nil respectively as revenue from the deferred revenue balance originating from
the acquisition of Aeterna Zentaris Inc. (note 3).
Liabilities
related to contracts with customers
The
following table provides a summary of deferred revenue balances:
Summary
of deferred revenue
| |
| Current | | |
| Non-current | | |
| Total | |
| |
June
30, 2024 | |
| |
Current | | |
Non-current | | |
Total | |
| |
| $ | | |
| $
| | |
| $
| |
Pharmanovia | |
| 97 | | |
| 1,484 | | |
| 1,581 | |
NK
Meditech | |
| - | | |
| 129 | | |
| 129 | |
Contract liabilities | |
| 97 | | |
| 1,613 | | |
| 1,710 | |
|
X |
- DefinitionThe entire disclosure for revenue.
+ ReferencesReference 1: http://www.xbrl.org/2009/role/commonPracticeRef -Name IAS -Number 1 -IssueDate 2023-01-01 -Paragraph 10 -Subparagraph e -URI https://taxonomy.ifrs.org/xifrs-link?type=IAS&num=1&code=ifrs-tx-2023-en-r&anchor=para_10_e&doctype=Standard -URIDate 2023-03-23
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v3.24.2.u1
Inventories
|
6 Months Ended |
Jun. 30, 2024 |
Notes and other explanatory information [abstract] |
|
Inventories |
5. Inventories
The
Company had the following inventories at the end of each reporting period:
Schedule
of inventories
| |
| | | |
| | |
| |
June
30, | | |
December
31, | |
| |
2024 | | |
2023 | |
| |
| $ | | |
| $ | |
Raw materials | |
| 767 | | |
| 889 | |
Work in progress | |
| 2,080 | | |
| 2,576 | |
Finished
goods | |
| 208 | | |
| 544 | |
Inventories | |
| 3,055 | | |
| 4,009 | |
Inventories
expensed to cost of goods sold during the three-month period ended June 30, 2024, are $1,398 (June 30, 2023 - $595) and the six-month
period ended June 30, 2024, are $2,467 (June 30, 2023 - $1,992).
|
X |
- DefinitionThe entire disclosure for inventories.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/disclosureRef -Name IAS -Number 2 -IssueDate 2023-01-01 -Section Disclosure -URI https://taxonomy.ifrs.org/xifrs-link?type=IAS&num=2&code=ifrs-tx-2023-en-r&doctype=Standard&dita_xref=IAS02_g36-39_TI -URIDate 2023-03-23
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v3.24.2.u1
Prepaid expenses and other assets
|
6 Months Ended |
Jun. 30, 2024 |
Notes and other explanatory information [abstract] |
|
Prepaid expenses and other assets |
6. Prepaid expenses and other assets
The
Company had the following prepaid expenses at the end of each reporting period:
Summary of prepaid expenses and other current assets
| |
| | | |
| | |
| |
June
30, | | |
December
31, | |
| |
2024 | | |
2023 | |
| |
| $ | | |
| $ | |
Prepaid insurance | |
| 4 | | |
| 81 | |
Prepaid research and development | |
| 681 | | |
| 97 | |
Other | |
| 309 | | |
| 112 | |
Total | |
| 994 | | |
| 290 | |
COSCIENS
Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
|
X |
- DefinitionThe disclosure of prepayments and other assets. [Refer: Other assets; Prepayments]
+ ReferencesReference 1: http://www.xbrl.org/2009/role/commonPracticeRef -Name IAS -Number 1 -IssueDate 2023-01-01 -Paragraph 10 -Subparagraph e -URI https://taxonomy.ifrs.org/xifrs-link?type=IAS&num=1&code=ifrs-tx-2023-en-r&anchor=para_10_e&doctype=Standard -URIDate 2023-03-23
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v3.24.2.u1
Property and equipment
|
6 Months Ended |
Jun. 30, 2024 |
Notes and other explanatory information [abstract] |
|
Property and equipment |
7. Property and equipment
Components
of the Company’s property and equipment are summarized below.
Schedule
of property and equipment
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| |
Cost | |
| |
Equipment
Not Available for Use | | |
Equipment | | |
Office
and Computer Equipment | | |
Buildings | | |
Leasehold
Improvements | | |
Total | |
| |
| $ | | |
| $ | | |
| $ | | |
| $ | | |
| $ | | |
| $ | |
At January 1,
2023 | |
| 1,462 | | |
| 9,223 | | |
| 681 | | |
| 2,730 | | |
| 6,442 | | |
| 20,538 | |
Additions | |
| 683 | | |
| 68 | | |
| 20 | | |
| - | | |
| 86 | | |
| 857 | |
Disposals | |
| - | | |
| (438 | ) | |
| - | | |
| - | | |
| - | | |
| (438 | ) |
Impact
of foreign exchange rate changes | |
| 54 | | |
| 206 | | |
| 16 | | |
| 64 | | |
| 152 | | |
| 492 | |
At December 31, 2023 | |
| 2,199 | | |
| 9,059 | | |
| 717 | | |
| 2,794 | | |
| 6,680 | | |
| 21,449 | |
Property plant and equipment | |
| 2,199 | | |
| 9,059 | | |
| 717 | | |
| 2,794 | | |
| 6,680 | | |
| 21,449 | |
Acquisition of Aeterna (note
3) | |
| - | | |
| 124 | | |
| 23 | | |
| 88 | | |
| - | | |
| 235 | |
Additions | |
| 700 | | |
| 6 | | |
| 3 | | |
| - | | |
| 12 | | |
| 721 | |
Impact
of foreign exchange rate changes | |
| (77 | ) | |
| (294 | ) | |
| (26 | ) | |
| (99 | ) | |
| (217 | ) | |
| (713 | ) |
At
June 30, 2024 | |
| 2,822 | | |
| 8,895 | | |
| 717 | | |
| 2,783 | | |
| 6,475 | | |
| 21,692 | |
Property plant and equipment | |
| 2,822 | | |
| 8,895 | | |
| 717 | | |
| 2,783 | | |
| 6,475 | | |
| 21,692 | |
| |
Accumulated
Depreciation | |
| |
Equipment
Not Available for Use | | |
Equipment | | |
Office
and Computer Equipment | | |
Buildings | | |
Leasehold
Improvements | | |
Total | |
| |
| $ | | |
| $ | | |
| $ | | |
| $ | | |
| $ | | |
| $ | |
At January 1,
2023 | |
| - | | |
| 4,842 | | |
| 565 | | |
| 997 | | |
| 2,180 | | |
| 8,584 | |
Amortization | |
| - | | |
| 630 | | |
| 34 | | |
| 287 | | |
| 490 | | |
| 1,441 | |
Disposals | |
| - | | |
| (438 | ) | |
| - | | |
| - | | |
| - | | |
| (438 | ) |
Impact
of foreign exchange rate changes | |
| - | | |
| 114 | | |
| 14 | | |
| 29 | | |
| 60 | | |
| 217 | |
At December 31, 2023 | |
| - | | |
| 5,148 | | |
| 613 | | |
| 1,313 | | |
| 2,730 | | |
| 9,804 | |
Property plant and equipment | |
| - | | |
| 5,148 | | |
| 613 | | |
| 1,313 | | |
| 2,730 | | |
| 9,804 | |
Amortization | |
| - | | |
| 307 | | |
| 14 | | |
| 142 | | |
| 249 | | |
| 712 | |
Impact
of foreign exchange rate changes | |
| - | | |
| (167 | ) | |
| (22 | ) | |
| (44 | ) | |
| (90 | ) | |
| (323 | ) |
At
June 30, 2024 | |
| - | | |
| 5,288 | | |
| 605 | | |
| 1,411 | | |
| 2,889 | | |
| 10,193 | |
Property plant and equipment | |
| - | | |
| 5,288 | | |
| 605 | | |
| 1,411 | | |
| 2,889 | | |
| 10,193 | |
| |
Carrying
amount | |
| |
Equipment
Not Available for Use | | |
Equipment | | |
Office
and Computer Equipment | | |
Buildings | | |
Leasehold
Improvements | | |
Total | |
| |
| $ | | |
| $ | | |
| $ | | |
| $ | | |
| $ | | |
| $ | |
At December
31, 2023 | |
| 2,199 | | |
| 3,911 | | |
| 104 | | |
| 1,481 | | |
| 3,950 | | |
| 11,645 | |
Property plant and equipment, Beginning | |
| 2,199 | | |
| 3,911 | | |
| 104 | | |
| 1,481 | | |
| 3,950 | | |
| 11,645 | |
At
June 30, 2024 | |
| 2,822 | | |
| 3,607 | | |
| 112 | | |
| 1,372 | | |
| 3,586 | | |
| 11,499 | |
Property plant and equipment, Ending | |
| 2,822 | | |
| 3,607 | | |
| 112 | | |
| 1,372 | | |
| 3,586 | | |
| 11,499 | |
COSCIENS
Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
Depreciation
expense is allocated to the following expense categories:
Schedule of
depreciation expenses
| |
| | | |
| | | |
| | | |
| | |
| |
Cost
of goods sold | | |
Selling,
general and administrative | | |
Research
and development | | |
Total | |
| |
| $ | | |
| $ | | |
| $ | | |
| $ | |
Six Months
Ended June 30, 2023 | |
| 579 | | |
| 142 | | |
| - | | |
| 721 | |
Six
Months Ended June 30, 2024 | |
| 514 | | |
| 157 | | |
| 41 | | |
| 712 | |
Included
right-of-use in the net carrying amount of property and equipment at June 30, 2024, are assets relating to buildings, in the amount of
$1,372 (December 31, 2023 - $1,481).
Included
in the carrying amount of leasehold improvements is $800 (December 31, 2023 - $800) and included in the carrying amount of equipment
not available for use is $2,822 (December 31, 2023 - $2,199) which represent the accumulated expenditures incurred on the purchase of
an ethanol recovery system, equipment purchased for technology scale-up, other equipment, and the engineering design for the related
construction and installation of the ethanol recovery system. Construction and installation activities related to technology scale-up
have progressed since year-end. However, as the activities had not yet been finalized, depreciation on these balances has not commenced.
The
Company has entered into a purchase commitment with a European specialized engineering firm for the supply of engineering, services and
equipment related to the construction of a PGX-100 pilot plant for $947 (€1,015). Payments made toward the purchase are included
in the carrying amount of equipment not available for use. As of June 30, 2024, the remaining purchase commitment is $678 (€727)
and is expected to be completed in 2024.
COSCIENS
Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
|
X |
- DefinitionThe entire disclosure for property, plant and equipment.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/disclosureRef -Name IAS -Number 16 -IssueDate 2023-01-01 -Section Disclosure -URI https://taxonomy.ifrs.org/xifrs-link?type=IAS&num=16&code=ifrs-tx-2023-en-r&doctype=Standard&dita_xref=IAS16_g73-79_TI -URIDate 2023-03-23
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v3.24.2.u1
Intangible assets
|
6 Months Ended |
Jun. 30, 2024 |
Notes and other explanatory information [abstract] |
|
Intangible assets |
8. Intangible assets
Changes
in the carrying value of the Company’s identifiable intangible assets are summarized below.
Schedule
of Intangible Assets
| |
Cost | | |
Accumulated
amortization | | |
Carrying
value | |
| |
As
at June 30, 2024 | |
| |
Cost | | |
Accumulated
amortization | | |
Carrying
value | |
| |
| $ | | |
| | | |
| $ | |
At January 1,
2024 | |
| 34 | | |
| (27 | ) | |
| 7 | |
Acquisition of Aeterna (note
3) | |
| 3,352 | | |
| - | | |
| 3,352 | |
Amortization | |
| - | | |
| (24 | ) | |
| (24 | ) |
Impact
of foreign exchange rate changes | |
| 1 | | |
| (1 | ) | |
| - | |
At
June 30, 2024 | |
| 3,387 | | |
| (52 | ) | |
| 3,335 | |
| |
As
at December 31, 2023 | |
| |
Cost | | |
Accumulated
amortization | | |
Carrying
value | |
| |
| $ | | |
| | | |
| $ | |
At January 1, 2023 | |
| 33 | | |
| (24 | ) | |
| 9 | |
Acquisition of Aeterna (note
3) | |
| - | | |
| - | | |
| - | |
Amortization | |
| - | | |
| (3 | ) | |
| (3 | ) |
Impact
of foreign exchange rate changes | |
| 1 | | |
| - | | |
| 1 | |
At December 31, 2023 | |
| 34 | | |
| (27 | ) | |
| 7 | |
|
X |
- DefinitionThe entire disclosure for intangible assets.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/disclosureRef -Name IAS -Number 38 -IssueDate 2023-01-01 -Section Disclosure -URI https://taxonomy.ifrs.org/xifrs-link?type=IAS&num=38&code=ifrs-tx-2023-en-r&doctype=Standard&dita_xref=IAS38_g118-128_TI -URIDate 2023-03-23
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v3.24.2.u1
Accounts payable
|
6 Months Ended |
Jun. 30, 2024 |
Notes and other explanatory information [abstract] |
|
Accounts payable |
9. Accounts payable
The
Company had the following accounts payable and accrued expenses at the end of each reporting period:
Summary
of detailed information about accounts payable and accrued expenses
| |
June
30, | | |
December
31, | |
| |
2024 | | |
2023 | |
| |
| $ | | |
| $ | |
Trade accounts
payable | |
| 3,585 | | |
| 281 | |
Accrued research and development
costs | |
| 510 | | |
| - | |
Accrued employee benefits | |
| 472 | | |
| 130 | |
Payroll tax and other statutory
liabilities | |
| 7 | | |
| - | |
Other
accrued liabilities | |
| 1,267 | | |
| 601 | |
Accounts
Payables and accrued liabilities | |
| 5,841 | | |
| 1,012 | |
COSCIENS
Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
|
X |
- DefinitionThe disclosure of trade and other payables. [Refer: Trade and other payables]
+ ReferencesReference 1: http://www.xbrl.org/2009/role/commonPracticeRef -Name IAS -Number 1 -IssueDate 2023-01-01 -Paragraph 10 -Subparagraph e -URI https://taxonomy.ifrs.org/xifrs-link?type=IAS&num=1&code=ifrs-tx-2023-en-r&anchor=para_10_e&doctype=Standard -URIDate 2023-03-23
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v3.24.2.u1
Employee future benefits
|
6 Months Ended |
Jun. 30, 2024 |
Notes and other explanatory information [abstract] |
|
Employee future benefits |
10. Employee future benefits
The
change in the Company’s employee future benefit obligations is summarized as follows:
Summary
of net employee future benefit liability asset
| |
| $ | | |
| $ | | |
| $ | |
| |
Six
months ended June
30, 2024 | |
| |
Pension | | |
Other | | |
| |
| |
benefit
plans | | |
benefit
plans | | |
Total | |
| |
| $ | | |
| $ | | |
| $ | |
Change
in plan liabilities | |
| | | |
| | | |
| | |
Balances – Beginning of the period | |
| - | | |
| - | | |
| - | |
Acquisition of
Aeterna (note 3) | |
| 22,036 | | |
| 100 | | |
| 22,136 | |
Current service cost | |
| 10 | | |
| 1 | | |
| 11 | |
Interest cost | |
| 66 | | |
| - | | |
| 66 | |
Actuarial gain from changes
in financial assumptions | |
| - | | |
| - | | |
| - | |
Benefits paid | |
| (61 | ) | |
| - | | |
| (61 | ) |
Impact
of foreign exchange rate changes | |
| (271 | ) | |
| (2 | ) | |
| (273 | ) |
Balances
– End of the period | |
| 21,780 | | |
| 99 | | |
| 21,879 | |
| |
| | | |
| | | |
| | |
Change
in plan assets | |
| | | |
| | | |
| | |
Balances – Beginning of the period | |
| - | | |
| - | | |
| - | |
Acquisition of Aeterna Zentaris
Inc. (note 3) | |
| 10,972 | | |
| - | | |
| 10,972 | |
Interest income from plan
assets | |
| 33 | | |
| - | | |
| 33 | |
Employer contributions | |
| 3 | | |
| - | | |
| 3 | |
Employee contributions | |
| 1 | | |
| - | | |
| 1 | |
Benefits paid | |
| (21 | ) | |
| - | | |
| (21 | ) |
Impact
of foreign exchange rate changes | |
| (136 | ) | |
| - | | |
| (136 | ) |
Balances
– End of the period | |
| 10,852 | | |
| - | | |
| 10,852 | |
| |
| | | |
| | | |
| | |
Net liability of the unfunded
plans | |
| 10,717 | | |
| 99 | | |
| 10,816 | |
Net
liability of the funded plans | |
| 211 | | |
| - | | |
| 211 | |
Net
amount recognized as Employee future benefits | |
| 10,928 | | |
| 99 | | |
| 11,027 | |
| |
| | | |
| | | |
| | |
Amounts recognized: | |
| | | |
| | | |
| | |
In net loss | |
| 42 | | |
| 1 | | |
| 43 | |
Actuarial gain on defined
benefit plans in other comprehensive loss | |
| - | | |
| - | | |
| - | |
The
calculation of the employee future benefit obligation is sensitive to the discount rate assumption and other assumptions such as the
rate of the pension benefit increase. There was no change in the discount rate of 3.70% used as of June 3, 2024 to the rate used as of
June 30, 2024, resulting in nil movement in the actuarial gain on defined benefit plan during the six months ended June 30, 2024.
COSCIENS
Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
|
X |
- DefinitionThe entire disclosure for employee benefits.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/disclosureRef -Name IAS -Number 19 -IssueDate 2023-01-01 -Section Scope -URI https://taxonomy.ifrs.org/xifrs-link?type=IAS&num=19&code=ifrs-tx-2023-en-r&doctype=Standard&dita_xref=IAS19_g2-7_TI -URIDate 2023-03-23
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v3.24.2.u1
Warrants
|
6 Months Ended |
Jun. 30, 2024 |
Warrants |
|
Warrants |
11. Warrants
Warrant
activity for the six months ended June 30, 2024, was as follows:
Summary
of warrants activity reclassified equity
| |
Warrants | | |
Weighted
average exercise price | | |
Amount | |
| |
| # | | |
| $ | | |
| $ | |
Balance – December
31, 2023 | |
| - | | |
| - | | |
| - | |
Warrants
either issued or assumed as part of the acquisition of Aeterna (note 3) | |
| 747,948 | | |
| 13.32 | | |
| 4,424 | |
Change
in fair value of warrants | |
| - | | |
| - | | |
| (1,628 | ) |
Balance
– June 30, 2024 | |
| 747,948 | | |
| 13.32 | | |
| 2,796 | |
The
method and inputs used in estimating the fair value of warrants on the acquisition date are described in Note 3. The fair values of warrants
as at June 30, 2024 are estimated using the Black-Scholes option pricing model. The weighted average assumptions used in the Black-Scholes
valuation model for the period presented were as follows:
Summary
of fair values of warrants assumptions
| |
| June
30, 2024 | |
Expected dividend
yield | |
$ | 0.00 | |
Expected volatility | |
| 65.00 | % |
Risk-free annual interest
rate | |
| 4.47 | % |
Expected life (years) | |
| 2.65 | |
Weighted average share price | |
$ | 6.99 | |
Weighted average exercise price | |
$ | 13.32 | |
At
June 30, 2024, the following warrants were outstanding:
Schedule
of warrants outstanding
Issuance
date | |
Number | | |
Weighted
average remaining contractual life | | |
Weighted
average exercise price | |
| |
| # | | |
| years | | |
| $ | |
September 2019 | |
| 13,249 | | |
| 0.24 | | |
| 165.00 | |
February 2020 | |
| 11,129 | | |
| 1.14 | | |
| 129.12 | |
July 2020 | |
| 56,210 | | |
| 1.01 | | |
| 45.00 | |
August 2020 | |
| 17,310 | | |
| 1.60 | | |
| 47.00 | |
February 2021 | |
| 16,507 | | |
| 1.64 | | |
| 181.25 | |
June 2024 | |
| 633,543 | | |
| 2.93 | | |
| 0.01 | |
Balance
– June 30, 2024 | |
| 747,948 | | |
| 2.65 | | |
| 13.32 | |
COSCIENS
Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
|
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v3.24.2.u1
Deferred share units
|
6 Months Ended |
Jun. 30, 2024 |
Deferred Share Units |
|
Deferred share units |
12. Deferred share units
The
compensation expense for the six months ended June 30, 2024, was a gain of $127 (2023 - nil) and is presented in selling, general and
administrative expenses. DSU activity for the six months ended June 30, 2024, was as follows:
Summary
of number and weighted average exercise prices of deferred shares units
| |
Units | | |
Amount | |
| |
# | | |
$ | |
Balance – January 1,
2024 | |
| - | | |
| - | |
Granted –
Replacement awards (note 3) | |
| 49,230 | | |
| 344 | |
Change
in fair value of DSUs | |
| - | | |
| (127 | ) |
Balance
– June 30, 2024 | |
| 49,230 | | |
| 217 | |
|
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v3.24.2.u1
Shareholders’ equity
|
6 Months Ended |
Jun. 30, 2024 |
Notes and other explanatory information [abstract] |
|
Shareholders’ equity |
13. Shareholders’ equity
Share
capital
The
Company has authorized an unlimited number of common shares (being voting and participating shares) with no par value, as well as an
unlimited number of preferred, first and second ranking shares, issuable in series, with rights and privileges specific to each class,
with no par value.
Summary of share capital
| |
Common
shares | | |
Amount | |
| |
# | | |
$ | |
Balance –
December 31, 2023 | |
| 1,847,593 | | |
| 13,517 | |
Deemed
issuance of shares to Aeterna shareholders (note 3) | |
| 1,213,967 | | |
| 8,485 | |
Balance
– June 30, 2024 | |
| 3,061,560 | | |
| 22,002 | |
As
discussed in Note 1, Business Overview, on June 3, 2024, each outstanding Ceapro common share was exchanged for 0.02360 of an Aeterna
common share. Accordingly, all common shares, stock options and per share amounts in these interim
condensed consolidated financial statements have been retroactively adjusted for all periods presented to give effect to the share exchange.
Share-based
compensation
The
Company grants stock options to eligible employees, directors, officers, and consultants under stock option plans. In accordance with
the terms of the Plan of Arrangement, the 12,949 share-based payment awards held by employees of Aeterna prior to the transaction date
of June 3, 2024 are deemed to be replacement awards issued with no modifications. Furthermore, in the six months ended June 30, 2024,
the Company granted nil (2023 – 21,004) new stock options. The stock options have a term of seven years and will vest over a period
of three years. The fair value at grant date is estimated using a Black-Scholes option pricing model, considering the terms and conditions
upon which the options were granted, using the following assumptions:
Summary
of assumptions to determine share-based compensation options granted
| |
June
30, 2023 | |
Expected dividend
yield | |
$ | 0.00 | |
Expected volatility | |
| 65.00 | % |
Risk-free annual interest
rate | |
| 3.21 | % |
Expected life (years) | |
| 5.0 | |
Share price | |
$ | 25.85 | |
Exercise price | |
$ | 25.85 | |
Grant date fair value | |
$ | 14.83 | |
COSCIENS
Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
The
expected volatility of these stock options was determined using historical volatility rates and the expected life was determined using
the weighted average life of past options issued.
The
compensation expense for the three months ended June 30, 2024, was $13 (2023 – $43) and for the six months ended June 30, 2024,
was $27 (2023 – $142) recognized over the vesting period. Option activity for the six months ended June 30, 2024, and 2023, was
as follows:
Summary
of number and weighted average exercise prices of deferred shares units
| |
Stock
options | | |
Weighted
average exercise price | |
| |
# | | |
$ | |
Balance –
January 1, 2024 | |
| 74,371 | | |
| 20.74 | |
Granted - Replacement options
(note 3) | |
| 12,949 | | |
| 50.65 | |
Cancelled
/ Forfeited | |
| (6,442 | ) | |
| 12.07 | |
Balance
– June 30, 2024 | |
| 80,878 | | |
| 26.22 | |
| |
| Stock
options | | |
| Weighted
average exercise price | |
| |
| # | | |
| $ | |
Balance – January 1,
2023 | |
| 64,735 | | |
| 20.46 | |
Granted | |
| 21,004 | | |
| 19.00 | |
Exercised | |
| (472 | ) | |
| 2.92 | |
Cancelled
/ Forfeited | |
| (944 | ) | |
| 19.00 | |
Balance
– June 30, 2023 | |
| 84,323 | | |
| 20.46 | |
Concurrent
with the Transaction described in Note 1, Business Overview, on June 3, 2024, each outstanding stock option was reissued to reflect the
exchange rate of the Company’s common shares and to convert the exercise price into U.S. dollar. Accordingly,
all quantities and prices in these interim condensed consolidated financial statements have been retroactively adjusted for all periods
presented to give effect to the share exchange and related adjustments.
|
X |
- DefinitionThe entire disclosure for share capital, reserves and other equity interest.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/disclosureRef -Name IAS -Number 1 -IssueDate 2023-01-01 -Paragraph 79 -URI https://taxonomy.ifrs.org/xifrs-link?type=IAS&num=1&code=ifrs-tx-2023-en-r&anchor=para_79&doctype=Standard -URIDate 2023-03-23
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v3.24.2.u1
Fair value of financial instruments
|
6 Months Ended |
Jun. 30, 2024 |
Notes and other explanatory information [abstract] |
|
Fair value of financial instruments |
14. Fair value of financial instruments
The
following presents financial assets and liabilities measured at fair value in the statement of financial position in accordance with
the fair value hierarchy.
In
establishing fair value, the Company uses a fair value hierarchy based on levels as defined below:
|
● |
Level
1: quoted prices (unadjusted) in active markets for identical assets or liabilities at the reporting date; |
|
● |
Level
2: inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly;
and |
|
● |
Level
3: inputs that are based on little or no observable market data, therefore requiring entities to develop their own assumptions. |
The
Company has determined that, excluding the derivative warrants, the carrying amounts of its current financial assets and financial liabilities
approximate their fair value given the short-term nature of these instruments.
As
at June 30, 2024 and December 31, 2023, the warrants is the only financial instrument measured at fair value in the condensed interim
consolidated statement of financial position. The warrants having an exercise price of $0.01 are classified in level 2 and their fair
value has been estimated by reference to the quoted price of the underlying shares at the reporting date. The fair value of all other
warrants measured at fair value are classified in level 3.
COSCIENS
Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
|
X |
- DefinitionThe disclosure of the fair value of financial instruments. [Refer: Financial instruments, class [member]; At fair value [member]]
+ ReferencesReference 1: http://www.xbrl.org/2009/role/commonPracticeRef -Name IAS -Number 1 -IssueDate 2023-01-01 -Paragraph 10 -Subparagraph e -URI https://taxonomy.ifrs.org/xifrs-link?type=IAS&num=1&code=ifrs-tx-2023-en-r&anchor=para_10_e&doctype=Standard -URIDate 2023-03-23
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v3.24.2.u1
Supplemental disclosure of cash flow information
|
6 Months Ended |
Jun. 30, 2024 |
Notes and other explanatory information [abstract] |
|
Supplemental disclosure of cash flow information |
15. Supplemental disclosure of cash flow information
Summary of changes in operating assets and liabilities
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three
months ended | | |
Six
months ended | |
| |
June
30, | | |
June
30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| $ | | |
| $ | | |
| $ | | |
| $ | |
Changes in operating assets
and liabilities: | |
| | | |
| | | |
| | | |
| | |
Trade
and other receivables | |
| 427 | | |
| 987 | | |
| (684 | ) | |
| 927 | |
Inventory | |
| 501 | | |
| (673 | ) | |
| 894 | | |
| (1,034 | ) |
Prepaid
expenses and other current assets | |
| 368 | | |
| 51 | | |
| 248 | | |
| 26 | |
Payables
and accrued liabilities | |
| 565 | | |
| (488 | ) | |
| 442 | | |
| (966 | ) |
Provision
for restructuring and other costs | |
| 1 | | |
| - | | |
| 1 | | |
| - | |
Employee
future benefits | |
| (44 | ) | |
| - | | |
| (44 | ) | |
| - | |
Increase
(decrease) in operating assets and liabilities | |
| 1,818 | | |
| (123 | ) | |
| 857 | | |
| (1,047 | ) |
|
X |
- DefinitionThe entire disclosure for a statement of cash flows.
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v3.24.2.u1
Net loss per share
|
6 Months Ended |
Jun. 30, 2024 |
Notes and other explanatory information [abstract] |
|
Net loss per share |
16. Net loss per share
The
following table sets forth pertinent data relating to the computation of basic and diluted net loss per share attributable to common
shareholders.
Summary of pertinent data relating to computation of basic and diluted net loss per share
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three
months ended | | |
Six
months ended | |
| |
June
30, | | |
June
30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| $ | | |
| $ | | |
| $ | | |
| $ | |
Net
loss | |
| (1,422 | ) | |
| (860 | ) | |
| (2,823 | ) | |
| (1,145 | ) |
Basic and diluted weighted-average
shares outstanding | |
| 2,220,303 | | |
| 1,846,775 | | |
| 2,033,539 | | |
| 1,846,759 | |
| |
| | | |
| | | |
| | | |
| | |
Basic and
diluted loss per share | |
| (0.64 | ) | |
| (0.47 | ) | |
| (1.39 | ) | |
| (0.62 | ) |
| |
| | | |
| | | |
| | | |
| | |
Items excluded from the calculation
of diluted net loss per share due to their anti-dilutive effect: | |
| | | |
| | | |
| | | |
| | |
Stock options and DSUs | |
| 130,108 | | |
| 84,323 | | |
| 130,108 | | |
| 84,323 | |
Warrants | |
| 747,948 | | |
| - | | |
| 747,948 | | |
| - | |
COSCIENS
Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
|
X |
- DefinitionThe entire disclosure for earnings per share.
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v3.24.2.u1
Segment information
|
6 Months Ended |
Jun. 30, 2024 |
Notes and other explanatory information [abstract] |
|
Segment information |
17. Segment information
As
of June 30, 2024 and a result of the transaction, the Company has two reportable and operating segments: Active ingredient and Biopharmaceutical.
The Group’s chief operating decision maker assesses the performance of the reportable segments based on revenues and operating
loss before selling, general & administrative expenses, other income and tax by segment. Selling, general and administrative expenses
are expenses and salaries related to centralized functions, such as corporate finance, legal, human resources and technology teams, which
are not allocated to segments. Accounting policies applied for the Active ingredient and the Biopharmaceutical segments are identical
to those used for the purposes of the consolidated financial statements as described in Note 2.
Active
ingredients
The
Active ingredient segment involves the development of proprietary extraction technologies and the application of these technologies to
the production and development and commercialization of active ingredients derived from oats and other renewable plant resources for
healthcare and cosmetic industries. Active ingredients produced include oat beta glucan, oat oil and avenanthramides. These and similar
manufactured products are sold primarily through distribution networks.
Biopharmaceutical
The
Biopharmaceutical segment includes the results of Aeterna Zentaris from its acquisition on June 3, 2024 (Note 3). The segment involves
the commercializing and developing pharmaceutical therapeutics and diagnostic tests, including the Company’s lead product, Macrilen®
(macimorelin). The segment also includes costs associated with the development of our pre-clinical pipeline to potentially address unmet
medical needs across several indications with a focus on rare or orphan indications.
COSCIENS
Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
The
table below summarizes the relevant financial information by operating segment:
Summary relevant financial information by operating segment
| |
Active
ingredient | | |
Biopharmaceutical | | |
Total | |
| |
Three
months ended June 30, 2024 | |
| |
Active
ingredient | | |
Biopharmaceutical | | |
Total | |
| |
| $ | | |
| $ | | |
| $ | |
Revenue | |
| 2,334 | | |
| 3 | | |
| 2,337 | |
Cost of sales | |
| (1,514 | ) | |
| (4 | ) | |
| (1,518 | ) |
Gross margin | |
| 820 | | |
| (1 | ) | |
| 819 | |
Research
and development | |
| (782 | ) | |
| (748 | ) | |
| (1,530 | ) |
Loss
from operations before SG&A and other income (expenses) | |
| 38 | | |
| (749 | ) | |
| (711 | ) |
Selling,
general & administrative | |
| | | |
| | | |
| (3,044 | ) |
Loss
from operations | |
| | | |
| | | |
| (3,755 | ) |
Net
other income | |
| | | |
| | | |
| 1,859 | |
Loss
before income taxes | |
| | | |
| | | |
| (1,896 | ) |
| |
Active
ingredient | | |
Biopharmaceutical | | |
Total | |
| |
Three
months ended June 30, 2023 | |
| |
Active
ingredient | | |
Biopharmaceutical | | |
Total | |
| |
| $ | | |
| $ | | |
| $ | |
Revenue | |
| 1,392 | | |
| - | | |
| 1,392 | |
Cost of sales | |
| (595 | ) | |
| - | | |
| (595 | ) |
Gross margin | |
| 797 | | |
| - | | |
| 797 | |
Research
and development | |
| (691 | ) | |
| - | | |
| (691 | ) |
Income
from operations before SG&A and other income (expenses) | |
| 106 | | |
| - | | |
| 106 | |
Selling,
general & administrative | |
| | | |
| | | |
| (1,220 | ) |
Loss
from operations | |
| | | |
| | | |
| (1,114 | ) |
Net
other income | |
| | | |
| | | |
| 19 | |
Loss
before income taxes | |
| | | |
| | | |
| (1,095 | ) |
COSCIENS
Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
| |
Active
ingredient | | |
Biopharmaceutical | | |
Total | |
| |
Six
months ended June 30, 2024 | |
| |
Active
ingredient | | |
Biopharmaceutical | | |
Total | |
| |
| $ | | |
| $ | | |
| $ | |
Revenue | |
| 4,391 | | |
| 3 | | |
| 4,394 | |
Cost of sales | |
| (2,667 | ) | |
| (4 | ) | |
| (2,671 | ) |
Gross margin | |
| 1,724 | | |
| (1 | ) | |
| 1,723 | |
Research
and development | |
| (1,844 | ) | |
| (748 | ) | |
| (2,592 | ) |
Loss
from operations before SG&A and other income (expenses) | |
| (120 | ) | |
| (749 | ) | |
| (869 | ) |
Selling,
general & administrative | |
| | | |
| | | |
| (4,710 | ) |
Loss
from operations | |
| | | |
| | | |
| (5,579 | ) |
Net
other income | |
| | | |
| | | |
| 1,870 | |
Loss
before income taxes | |
| | | |
| | | |
| (3,709 | ) |
| |
Active
ingredient | | |
Biopharmaceutical | | |
Total | |
| |
Six
months ended June 30, 2023 | |
| |
Active
ingredient | | |
Biopharmaceutical | | |
Total | |
| |
| $ | | |
| $ | | |
| $ | |
Revenue | |
| 3,977 | | |
| - | | |
| 3,977 | |
Cost of sales | |
| (1,992 | ) | |
| - | | |
| (1,992 | ) |
Gross margin | |
| 1,985 | | |
| - | | |
| 1,985 | |
Research
and development | |
| (1,115 | ) | |
| - | | |
| (1,115 | ) |
Income
from operations before SG&A and other income (expenses) | |
| 870 | | |
| - | | |
| 870 | |
Income
(Loss) from operations before SG&A and other income (expenses) | |
| 870 | | |
| - | | |
| 870 | |
Selling,
general & administrative | |
| | | |
| | | |
| (2,352 | ) |
Loss
from operations | |
| | | |
| | | |
| (1,482 | ) |
Net
other income | |
| | | |
| | | |
| 24 | |
Loss
before income taxes | |
| | | |
| | | |
| (1,458 | ) |
Major
Customer
During
the three and six months ended June 30, 2024, the Company had export sales to one major distributor of the Company’s products representing
87% of total revenue (2023 - 89% of total revenue). As at June 30, 2024, one customer represented 84% of total accounts receivable and
other receivables (June 30, 2023 – one major customer amounted to 92%).
COSCIENS
Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
|
X |
- DefinitionThe entire disclosure for operating segments.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/disclosureRef -Name IFRS -Number 8 -IssueDate 2023-01-01 -Section Disclosure -URI https://taxonomy.ifrs.org/xifrs-link?type=IFRS&num=8&code=ifrs-tx-2023-en-r&doctype=Standard&dita_xref=IFRS08_g20-24_TI -URIDate 2023-03-23
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|
v3.24.2.u1
Commitments
|
6 Months Ended |
Jun. 30, 2024 |
Notes and other explanatory information [abstract] |
|
Commitments |
18. Commitments
Significant
expenditure under contracted supply agreements for at the end of the reporting period but not recognized as liabilities is as follows:
Schedule of expected
future minimum lease payments
| |
TOTAL | |
| |
$ | |
Less than 1 year | |
| 4,352 | |
1 - 3 years | |
| 54 | |
4 - 5 years | |
| - | |
More
than 5 years | |
| - | |
Minimum lease payments, net | |
| 4,406 | |
The
Company executed various agreements including in-licensing and similar arrangements with development partners. Such agreements may require
the Company to make payments on achievement of stages of development, launch or revenue milestones, although the Company generally has
the right to terminate these agreements at no penalty. The Company may have to pay up to $38,573 upon achieving certain sales volumes,
regulatory or other milestones related to specific products.
In
addition, the Company previously entered into license agreements for technologies to increase the concentration of avenanthramides in
oats and the rights to the PGX technology. As part of these agreements the Company shall pay an annual royalty percentage rate of 2.0%
specific avenanthramides sales and up to 3.5% of PGX sales respectively.
The
Company has entered into a purchase commitment with a European specialized engineering firm for the supply of engineering, services and
equipment related to the construction of a PGX-100 pilot plant (note 7). As of June 30, 2024 the remaining purchase commitment is $678
(€727) and is expected to be completed in 2024.
|
X |
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v3.24.2.u1
Basis of presentation (Policies)
|
6 Months Ended |
Jun. 30, 2024 |
Notes and other explanatory information [abstract] |
|
Business combinations |
Business
combinations
Business
combinations are accounted for using the acquisition method as at the acquisition date when control is transferred. The consideration
transferred for the acquisition of a business is the fair value of the assets transferred, and any liability and equity interests issued
by the Company to the former owners of the acquired business on the acquisition date. Identifiable assets acquired and liabilities assumed
in a business combination are generally measured initially at their fair values at the acquisition date. Acquisition-related costs other
than those associated with the issue of debt or equity securities, and other direct costs of a business combination are not considered
part of the business acquisition transaction and are expensed as incurred.
|
Foreign currency |
Foreign
currency
Effective
June 30, 2024, Ceapro has changed its reporting currency from Canadian dollars to U.S. dollars. This change in reporting currency has
been applied retrospectively such that all amounts in the consolidated financial statements of the Company and the accompanying notes
thereto are expressed in U.S. dollars. References to “$” are U.S. dollars and references to “CA $” are to Canadian
dollars. For comparative purposes, historical consolidated financial statements of Ceapro were recast in U.S. dollars by translating
assets and liabilities at the closing exchange rate in effect at the end of the respective period, revenues, expenses and cash flows
at the average exchange rate in effect for the respective period and equity transactions at historical exchange rates. Translation gains
and losses are included in the cumulative foreign currency translation adjustment, which is reported as a component of shareholders’
equity under accumulated other comprehensive loss.
|
Post-employment benefits |
Post-employment
benefits
The
Company has partially funded and unfunded defined benefit multi-employer pension plans, namely the DUPK pension plan and the RUK 1990
and 2006 pension plans, (the “Pension Benefit Plans”) and unfunded post-employment benefit plans in Germany. Provisions for
pension obligations are established for benefits payable in the form of retirement, disability and surviving dependent pensions. The
Company also provides defined contribution plans to some of its employees.
For
defined benefit pension plans and other post-employment benefits, net periodic pension expense is actuarially determined on a quarterly
basis using the projected unit credit method. The cost of pension and other benefits earned by employees is determined by applying certain
assumptions, including discount rates, rate of pension benefit increases, the projected age of employees upon retirement and the expected
rate of future compensation.
The
employee future benefits liability is recognized at its present value, which is determined by discounting the estimated future cash outflows
using interest rates of high-quality corporate bonds that are denominated in the currency in which the benefits will be paid and that
have terms to maturity approximating the terms of the related future benefit liability. Actuarial gains and losses that arise in calculating
the present value of the defined benefit obligation are recognized in other comprehensive loss, net of tax, and simultaneously reclassified
in the deficit in the consolidated statement of financial position in the year in which the actuarial gains and losses arise and without
recycling to the consolidated statement of loss and comprehensive loss in subsequent periods.
|
Revenue |
Revenue
The
Company generates revenue from supply agreements and licensing agreements with customers for the sale of certain finished goods, semi-finished
goods and active pharmaceutical ingredients. The license is generally combined with other promises to supply goods to the customer, and
revenue from the combined performance obligation is satisfied at a point in time, which occurs upon shipment. The transaction price for
the combined performance obligation includes the license non-refundable non-creditable upfront payment, regulatory milestones, royalties
and the selling price of each good supplied. Milestone payments, which are oftentimes payable upon the successful achievement of development
or regulatory events, and royalties are included in the transaction price using the most likely amount method only if the milestones
are considered probable of being reached and the Company concludes it is highly probable that a significant revenue reversal will not
occur. Milestone payments and royalties that are not within the control of the Company or the licensee, such as regulatory approvals,
are generally not considered probable of being achieved until those approvals or subsequent sales are received. The Company allocates
the transaction price to the projected units that the Company expects to supply pursuant to the contract, estimated based on current
projections and anticipated market demand.
|
Intangible assets |
Intangible
assets
Intangible
assets, consisting of patents, that are acquired by the Company and have finite useful lives are measured at cost less accumulated amortization
and any accumulated impairment losses. Patents are amortized on their respective remaining patent life and are expiring between 2027
and 2041.
|
Warrant liabilities |
Warrant
liabilities
Warrant
liabilities are derivative financial instruments. They are initially measured at fair value. Subsequent to initial recognition, they
are measured at fair value, and changes therein are recognised in profit or loss.
|
Reclassifications |
Reclassifications
Certain
prior period amounts have been reclassified to conform to current period presentation. In the consolidated statement of financial position,
trade receivables of $126 and other receivable of $164 were classified to trade and other receivables. In the consolidated statements
of loss for the six months ended June 30, 2023, the general and administration expenses of $2,336 (for the three months ended June 30,
2023 - $1,210) and the sales and marketing expenses of $16 (for the three months ended June 30, 2023 - $10) were reclassified within
Selling, general and administrative expenses.
|
New standards and amendments |
New
standards and amendments
Several
amendments apply for the first time for reporting periods beginning after January 1, 2024, but do not have an impact on the interim condensed
consolidated financial statements of the Company. The IASB has published several new, but not yet effective, standards, amendments to
existing standards, and interpretations. None of these standards, amendments to existing standards, or interpretations have been early
adopted by the Company, and management anticipates that all relevant pronouncements will be adopted for the first period beginning on
or after the effective date of the pronouncement. No pronouncements have been disclosed as they are not expected to have a material impact
on the Company’s condensed interim consolidated financial statements.
|
Critical accounting estimates and judgements |
Critical
accounting estimates and judgements
The
preparation of condensed interim consolidated financial statements in accordance with IFRS requires management to make judgements, estimates
and assumptions about the future that affect the reported amounts of the Company’s assets, liabilities, revenues, expenses and
related disclosures. Judgements, estimates and assumptions are based on historical experience, expectations, current trends and other
factors that management believes to be relevant at the time at which the Company’s condensed interim consolidated financial statements
are prepared.
Management
reviews, on a regular basis, the Company’s accounting policies, assumptions, estimates and judgements in order to ensure that the
condensed interim consolidated financial statements are presented fairly and in accordance with IFRS applicable to interim financial
statements. Revisions to estimates are recognized prospectively. Critical accounting estimates and assumptions, as well as critical judgements
used in applying accounting policies in the preparation of the Company’s condensed interim consolidated financial statements, were
the same as those applied to Ceapro’s annual consolidated financial statements as of and for the year ended December 31, 2023,
except for as described below:
|
● |
Measurement
of defined benefit obligations: key actuarial assumptions (note 10); and |
|
● |
Business
acquisition: identification of the acquirer, determination of the fair value of the consideration transferred and fair value of some
of the assets acquired and liabilities assumed (note 3). |
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v3.24.2.u1
Acquisition of Aeterna Zentaris Inc. (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
IfrsStatementLineItems [Line Items] |
|
Schedule of purchase price to the fair values of assets acquired and liabilities assumed |
Schedule
of purchase price to the fair values of assets acquired and liabilities assumed
Preliminary
Purchase Price Allocation
| |
| | | |
| | |
| |
Number | | |
Amount | |
| |
# | | |
$ | |
Purchase
price | |
| | | |
| | |
Shares deemed
issued to Aeterna shareholders(1) | |
| | |
| 8,485 | |
Warrants issued to Aeterna
shareholders(2) | |
| 633,543 | | |
| 4,422 | |
Replacement share-based
payment awards: | |
| | | |
| | |
Equity-settled options(3) | |
| 12,949 | | |
| 9 | |
Cash-settled DSUs(3) | |
| 49,230 | | |
| 344 | |
Warrants
deemed issued(4) | |
| 114,405 | | |
| 2 | |
| |
| 2,024,094 | | |
| 13,262 | |
| |
| | | |
| | |
Recognized
amounts of identifiable assets acquired and liabilities assumed | |
| | | |
| | |
Cash and cash equivalents | |
| | | |
| 26,037 | |
Trade and other receivables | |
| | | |
| 142 | |
Inventories | |
| | | |
| 64 | |
Income tax receivables | |
| | | |
| 119 | |
Prepaid expenses and deposits | |
| | | |
| 971 | |
Restricted cash equivalents | |
| | | |
| 328 | |
Property and equipment | |
| | | |
| 235 | |
Intangible assets(5) | |
| | | |
| 3,352 | |
Accounts payable and accrued
liabilities | |
| | | |
| (4,357 | ) |
Provisions | |
| | | |
| (424 | ) |
Income tax payable | |
| | | |
| (109 | ) |
Deferred revenues | |
| | | |
| (1,731 | ) |
Lease liabilities | |
| | | |
| (201 | ) |
Employee future benefits | |
| | | |
| (11,164 | ) |
| |
| | | |
| | |
Total
provisional identifiable net assets (liabilities) | |
| | | |
| 13,262 | |
|
(1) |
The fair value of the 1,213,967
common shares deemed issued to Aeterna shareholders of $6.99 per share was based on the listed share price of Ceapro as at June 3,
2024 (CA$0.225), after giving effect to the exchange of each outstanding Ceapro common share for 0.02360 of a Aeterna common share
and the foreign currency exchange rate. |
(In
thousands of US dollars, except share and per share data and as otherwise noted)
|
(2) |
The fair value of the 633,543
New Warrants issued to Aeterna shareholders was based on the listed share price of Ceapro as at June 3, 2024 of $6.99 (CA$0.225) less
the exercise price of $0.01, after giving effect to the exchange of each outstanding Ceapro Common Share for 0.02360 of a Aeterna Zentaris
Common Share and the foreign currency exchange rate. |
|
(3) |
In accordance with the terms
of the Plan of Arrangement, Aeterna’s share-based payment awards held by employees of Aeterna continued with no modifications
and are deemed to be replacement awards issued. |
|
(4) |
The fair value of the 114,405
warrants deemed issued to Aeterna warrant holders was estimated using a Black-Scholes option pricing model, considering the terms and
conditions upon which the warrants were issued, using the following assumptions: |
|
(5) |
The identifiable intangible
assets consist of patents expiring between 2027 and 2041 which will be amortized on their respective remaining patent life. To estimate
the fair value of the intangible assets, management uses the royalty relief method to value patents using discounted cash flow models.
Management developed assumptions related to revenue and EBITDA margin forecasts, attrition rates, royalty rates and discount rates. |
|
(4) |
The fair value of the 114,405
warrants deemed issued to Aeterna warrant holders was estimated using a Black-Scholes option pricing model, considering the terms and
conditions upon which the warrants were issued, using the following assumptions: |
|
Share options [member] |
|
IfrsStatementLineItems [Line Items] |
|
Schedule of fair value at acquisition date was estimated using a Black-Scholes option |
The
fair value at acquisition date was estimated using a Black-Scholes option pricing model, considering the terms and conditions upon which
the options were granted, using the following assumptions:
Schedule of fair value at acquisition date was estimated using a Black-Scholes option
| |
Options | |
Expected dividend
yield | |
$ | 0.0 | |
Weighted average expected volatility | |
| 65 | % |
Weighted average risk-free rate | |
| 4.01 | % |
Weighted average expected life (years) | |
| 2.87 | |
Share price | |
$ | 6.99 | |
Weighted average exercise price | |
$ | 50.15 | |
Weighted average fair value | |
$ | 0.90 | |
|
Warrants [member] |
|
IfrsStatementLineItems [Line Items] |
|
Schedule of fair value at acquisition date was estimated using a Black-Scholes option |
Schedule of fair value at acquisition date was estimated using a Black-Scholes option
| |
Warrants | |
Expected dividend
yield | |
$ | 0.00 | |
Weighted average expected volatility | |
| 65 | % |
Weighted average risk-free rate | |
| 4.47 | % |
Weighted average expected life (years) | |
| 1.19 | |
Share price | |
$ | 6.99 | |
Weighted average exercise price | |
$ | 87.04 | |
Weighted average fair value | |
$ | 0.02 | |
|
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v3.24.2.u1
Revenue (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Notes and other explanatory information [abstract] |
|
Summary of revenue from transfer of goods and services |
The
Company derives revenue from the transfer of goods at a point in time in the following categories:
Summary
of revenue from transfer of goods and services
| |
| | | |
| | | |
| | | |
| | |
| |
Three
months ended | | |
Six
months ended | |
| |
June
30, | | |
June
30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| $ | | |
| $ | | |
| $ | | |
| $ | |
Active ingredients | |
| 2,334 | | |
| 1,392 | | |
| 4,391 | | |
| 3,977 | |
Pharmaceutical | |
| 3 | | |
| - | | |
| 3 | | |
| - | |
Total | |
| 2,337 | | |
| 1,392 | | |
| 4,394 | | |
| 3,977 | |
|
Summary of deferred revenue |
The
following table provides a summary of deferred revenue balances:
Summary
of deferred revenue
| |
| Current | | |
| Non-current | | |
| Total | |
| |
June
30, 2024 | |
| |
Current | | |
Non-current | | |
Total | |
| |
| $ | | |
| $
| | |
| $
| |
Pharmanovia | |
| 97 | | |
| 1,484 | | |
| 1,581 | |
NK
Meditech | |
| - | | |
| 129 | | |
| 129 | |
Contract liabilities | |
| 97 | | |
| 1,613 | | |
| 1,710 | |
|
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v3.24.2.u1
Property and equipment (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Notes and other explanatory information [abstract] |
|
Schedule of property and equipment |
Components
of the Company’s property and equipment are summarized below.
Schedule
of property and equipment
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| |
Cost | |
| |
Equipment
Not Available for Use | | |
Equipment | | |
Office
and Computer Equipment | | |
Buildings | | |
Leasehold
Improvements | | |
Total | |
| |
| $ | | |
| $ | | |
| $ | | |
| $ | | |
| $ | | |
| $ | |
At January 1,
2023 | |
| 1,462 | | |
| 9,223 | | |
| 681 | | |
| 2,730 | | |
| 6,442 | | |
| 20,538 | |
Additions | |
| 683 | | |
| 68 | | |
| 20 | | |
| - | | |
| 86 | | |
| 857 | |
Disposals | |
| - | | |
| (438 | ) | |
| - | | |
| - | | |
| - | | |
| (438 | ) |
Impact
of foreign exchange rate changes | |
| 54 | | |
| 206 | | |
| 16 | | |
| 64 | | |
| 152 | | |
| 492 | |
At December 31, 2023 | |
| 2,199 | | |
| 9,059 | | |
| 717 | | |
| 2,794 | | |
| 6,680 | | |
| 21,449 | |
Property plant and equipment | |
| 2,199 | | |
| 9,059 | | |
| 717 | | |
| 2,794 | | |
| 6,680 | | |
| 21,449 | |
Acquisition of Aeterna (note
3) | |
| - | | |
| 124 | | |
| 23 | | |
| 88 | | |
| - | | |
| 235 | |
Additions | |
| 700 | | |
| 6 | | |
| 3 | | |
| - | | |
| 12 | | |
| 721 | |
Impact
of foreign exchange rate changes | |
| (77 | ) | |
| (294 | ) | |
| (26 | ) | |
| (99 | ) | |
| (217 | ) | |
| (713 | ) |
At
June 30, 2024 | |
| 2,822 | | |
| 8,895 | | |
| 717 | | |
| 2,783 | | |
| 6,475 | | |
| 21,692 | |
Property plant and equipment | |
| 2,822 | | |
| 8,895 | | |
| 717 | | |
| 2,783 | | |
| 6,475 | | |
| 21,692 | |
| |
Accumulated
Depreciation | |
| |
Equipment
Not Available for Use | | |
Equipment | | |
Office
and Computer Equipment | | |
Buildings | | |
Leasehold
Improvements | | |
Total | |
| |
| $ | | |
| $ | | |
| $ | | |
| $ | | |
| $ | | |
| $ | |
At January 1,
2023 | |
| - | | |
| 4,842 | | |
| 565 | | |
| 997 | | |
| 2,180 | | |
| 8,584 | |
Amortization | |
| - | | |
| 630 | | |
| 34 | | |
| 287 | | |
| 490 | | |
| 1,441 | |
Disposals | |
| - | | |
| (438 | ) | |
| - | | |
| - | | |
| - | | |
| (438 | ) |
Impact
of foreign exchange rate changes | |
| - | | |
| 114 | | |
| 14 | | |
| 29 | | |
| 60 | | |
| 217 | |
At December 31, 2023 | |
| - | | |
| 5,148 | | |
| 613 | | |
| 1,313 | | |
| 2,730 | | |
| 9,804 | |
Property plant and equipment | |
| - | | |
| 5,148 | | |
| 613 | | |
| 1,313 | | |
| 2,730 | | |
| 9,804 | |
Amortization | |
| - | | |
| 307 | | |
| 14 | | |
| 142 | | |
| 249 | | |
| 712 | |
Impact
of foreign exchange rate changes | |
| - | | |
| (167 | ) | |
| (22 | ) | |
| (44 | ) | |
| (90 | ) | |
| (323 | ) |
At
June 30, 2024 | |
| - | | |
| 5,288 | | |
| 605 | | |
| 1,411 | | |
| 2,889 | | |
| 10,193 | |
Property plant and equipment | |
| - | | |
| 5,288 | | |
| 605 | | |
| 1,411 | | |
| 2,889 | | |
| 10,193 | |
| |
Carrying
amount | |
| |
Equipment
Not Available for Use | | |
Equipment | | |
Office
and Computer Equipment | | |
Buildings | | |
Leasehold
Improvements | | |
Total | |
| |
| $ | | |
| $ | | |
| $ | | |
| $ | | |
| $ | | |
| $ | |
At December
31, 2023 | |
| 2,199 | | |
| 3,911 | | |
| 104 | | |
| 1,481 | | |
| 3,950 | | |
| 11,645 | |
Property plant and equipment, Beginning | |
| 2,199 | | |
| 3,911 | | |
| 104 | | |
| 1,481 | | |
| 3,950 | | |
| 11,645 | |
At
June 30, 2024 | |
| 2,822 | | |
| 3,607 | | |
| 112 | | |
| 1,372 | | |
| 3,586 | | |
| 11,499 | |
Property plant and equipment, Ending | |
| 2,822 | | |
| 3,607 | | |
| 112 | | |
| 1,372 | | |
| 3,586 | | |
| 11,499 | |
|
Schedule of depreciation expenses |
Depreciation
expense is allocated to the following expense categories:
Schedule of
depreciation expenses
| |
| | | |
| | | |
| | | |
| | |
| |
Cost
of goods sold | | |
Selling,
general and administrative | | |
Research
and development | | |
Total | |
| |
| $ | | |
| $ | | |
| $ | | |
| $ | |
Six Months
Ended June 30, 2023 | |
| 579 | | |
| 142 | | |
| - | | |
| 721 | |
Six
Months Ended June 30, 2024 | |
| 514 | | |
| 157 | | |
| 41 | | |
| 712 | |
|
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v3.24.2.u1
Intangible assets (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Notes and other explanatory information [abstract] |
|
Schedule of Intangible Assets |
Changes
in the carrying value of the Company’s identifiable intangible assets are summarized below.
Schedule
of Intangible Assets
| |
Cost | | |
Accumulated
amortization | | |
Carrying
value | |
| |
As
at June 30, 2024 | |
| |
Cost | | |
Accumulated
amortization | | |
Carrying
value | |
| |
| $ | | |
| | | |
| $ | |
At January 1,
2024 | |
| 34 | | |
| (27 | ) | |
| 7 | |
Acquisition of Aeterna (note
3) | |
| 3,352 | | |
| - | | |
| 3,352 | |
Amortization | |
| - | | |
| (24 | ) | |
| (24 | ) |
Impact
of foreign exchange rate changes | |
| 1 | | |
| (1 | ) | |
| - | |
At
June 30, 2024 | |
| 3,387 | | |
| (52 | ) | |
| 3,335 | |
| |
As
at December 31, 2023 | |
| |
Cost | | |
Accumulated
amortization | | |
Carrying
value | |
| |
| $ | | |
| | | |
| $ | |
At January 1, 2023 | |
| 33 | | |
| (24 | ) | |
| 9 | |
Acquisition of Aeterna (note
3) | |
| - | | |
| - | | |
| - | |
Amortization | |
| - | | |
| (3 | ) | |
| (3 | ) |
Impact
of foreign exchange rate changes | |
| 1 | | |
| - | | |
| 1 | |
At December 31, 2023 | |
| 34 | | |
| (27 | ) | |
| 7 | |
|
v3.24.2.u1
Accounts payable (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Notes and other explanatory information [abstract] |
|
Summary of detailed information about accounts payable and accrued expenses |
The
Company had the following accounts payable and accrued expenses at the end of each reporting period:
Summary
of detailed information about accounts payable and accrued expenses
| |
June
30, | | |
December
31, | |
| |
2024 | | |
2023 | |
| |
| $ | | |
| $ | |
Trade accounts
payable | |
| 3,585 | | |
| 281 | |
Accrued research and development
costs | |
| 510 | | |
| - | |
Accrued employee benefits | |
| 472 | | |
| 130 | |
Payroll tax and other statutory
liabilities | |
| 7 | | |
| - | |
Other
accrued liabilities | |
| 1,267 | | |
| 601 | |
Accounts
Payables and accrued liabilities | |
| 5,841 | | |
| 1,012 | |
|
v3.24.2.u1
Employee future benefits (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Notes and other explanatory information [abstract] |
|
Summary of net employee future benefit liability asset |
The
change in the Company’s employee future benefit obligations is summarized as follows:
Summary
of net employee future benefit liability asset
| |
| $ | | |
| $ | | |
| $ | |
| |
Six
months ended June
30, 2024 | |
| |
Pension | | |
Other | | |
| |
| |
benefit
plans | | |
benefit
plans | | |
Total | |
| |
| $ | | |
| $ | | |
| $ | |
Change
in plan liabilities | |
| | | |
| | | |
| | |
Balances – Beginning of the period | |
| - | | |
| - | | |
| - | |
Acquisition of
Aeterna (note 3) | |
| 22,036 | | |
| 100 | | |
| 22,136 | |
Current service cost | |
| 10 | | |
| 1 | | |
| 11 | |
Interest cost | |
| 66 | | |
| - | | |
| 66 | |
Actuarial gain from changes
in financial assumptions | |
| - | | |
| - | | |
| - | |
Benefits paid | |
| (61 | ) | |
| - | | |
| (61 | ) |
Impact
of foreign exchange rate changes | |
| (271 | ) | |
| (2 | ) | |
| (273 | ) |
Balances
– End of the period | |
| 21,780 | | |
| 99 | | |
| 21,879 | |
| |
| | | |
| | | |
| | |
Change
in plan assets | |
| | | |
| | | |
| | |
Balances – Beginning of the period | |
| - | | |
| - | | |
| - | |
Acquisition of Aeterna Zentaris
Inc. (note 3) | |
| 10,972 | | |
| - | | |
| 10,972 | |
Interest income from plan
assets | |
| 33 | | |
| - | | |
| 33 | |
Employer contributions | |
| 3 | | |
| - | | |
| 3 | |
Employee contributions | |
| 1 | | |
| - | | |
| 1 | |
Benefits paid | |
| (21 | ) | |
| - | | |
| (21 | ) |
Impact
of foreign exchange rate changes | |
| (136 | ) | |
| - | | |
| (136 | ) |
Balances
– End of the period | |
| 10,852 | | |
| - | | |
| 10,852 | |
| |
| | | |
| | | |
| | |
Net liability of the unfunded
plans | |
| 10,717 | | |
| 99 | | |
| 10,816 | |
Net
liability of the funded plans | |
| 211 | | |
| - | | |
| 211 | |
Net
amount recognized as Employee future benefits | |
| 10,928 | | |
| 99 | | |
| 11,027 | |
| |
| | | |
| | | |
| | |
Amounts recognized: | |
| | | |
| | | |
| | |
In net loss | |
| 42 | | |
| 1 | | |
| 43 | |
Actuarial gain on defined
benefit plans in other comprehensive loss | |
| - | | |
| - | | |
| - | |
|
X |
- DefinitionThe disclosure of a net defined benefit liability (asset). [Refer: Net defined benefit liability (asset)]
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v3.24.2.u1
Warrants (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Warrants |
|
Summary of warrants activity reclassified equity |
Warrant
activity for the six months ended June 30, 2024, was as follows:
Summary
of warrants activity reclassified equity
| |
Warrants | | |
Weighted
average exercise price | | |
Amount | |
| |
| # | | |
| $ | | |
| $ | |
Balance – December
31, 2023 | |
| - | | |
| - | | |
| - | |
Warrants
either issued or assumed as part of the acquisition of Aeterna (note 3) | |
| 747,948 | | |
| 13.32 | | |
| 4,424 | |
Change
in fair value of warrants | |
| - | | |
| - | | |
| (1,628 | ) |
Balance
– June 30, 2024 | |
| 747,948 | | |
| 13.32 | | |
| 2,796 | |
|
Summary of fair values of warrants assumptions |
Summary
of fair values of warrants assumptions
| |
| June
30, 2024 | |
Expected dividend
yield | |
$ | 0.00 | |
Expected volatility | |
| 65.00 | % |
Risk-free annual interest
rate | |
| 4.47 | % |
Expected life (years) | |
| 2.65 | |
Weighted average share price | |
$ | 6.99 | |
Weighted average exercise price | |
$ | 13.32 | |
|
Schedule of warrants outstanding |
At
June 30, 2024, the following warrants were outstanding:
Schedule
of warrants outstanding
Issuance
date | |
Number | | |
Weighted
average remaining contractual life | | |
Weighted
average exercise price | |
| |
| # | | |
| years | | |
| $ | |
September 2019 | |
| 13,249 | | |
| 0.24 | | |
| 165.00 | |
February 2020 | |
| 11,129 | | |
| 1.14 | | |
| 129.12 | |
July 2020 | |
| 56,210 | | |
| 1.01 | | |
| 45.00 | |
August 2020 | |
| 17,310 | | |
| 1.60 | | |
| 47.00 | |
February 2021 | |
| 16,507 | | |
| 1.64 | | |
| 181.25 | |
June 2024 | |
| 633,543 | | |
| 2.93 | | |
| 0.01 | |
Balance
– June 30, 2024 | |
| 747,948 | | |
| 2.65 | | |
| 13.32 | |
|
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v3.24.2.u1
Shareholders’ equity (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Notes and other explanatory information [abstract] |
|
Summary of share capital |
Summary of share capital
| |
Common
shares | | |
Amount | |
| |
# | | |
$ | |
Balance –
December 31, 2023 | |
| 1,847,593 | | |
| 13,517 | |
Deemed
issuance of shares to Aeterna shareholders (note 3) | |
| 1,213,967 | | |
| 8,485 | |
Balance
– June 30, 2024 | |
| 3,061,560 | | |
| 22,002 | |
|
Summary of assumptions to determine share-based compensation options granted |
Summary
of assumptions to determine share-based compensation options granted
| |
June
30, 2023 | |
Expected dividend
yield | |
$ | 0.00 | |
Expected volatility | |
| 65.00 | % |
Risk-free annual interest
rate | |
| 3.21 | % |
Expected life (years) | |
| 5.0 | |
Share price | |
$ | 25.85 | |
Exercise price | |
$ | 25.85 | |
Grant date fair value | |
$ | 14.83 | |
|
Summary of number and weighted average exercise prices of deferred shares units |
Summary
of number and weighted average exercise prices of deferred shares units
| |
Stock
options | | |
Weighted
average exercise price | |
| |
# | | |
$ | |
Balance –
January 1, 2024 | |
| 74,371 | | |
| 20.74 | |
Granted - Replacement options
(note 3) | |
| 12,949 | | |
| 50.65 | |
Cancelled
/ Forfeited | |
| (6,442 | ) | |
| 12.07 | |
Balance
– June 30, 2024 | |
| 80,878 | | |
| 26.22 | |
| |
| Stock
options | | |
| Weighted
average exercise price | |
| |
| # | | |
| $ | |
Balance – January 1,
2023 | |
| 64,735 | | |
| 20.46 | |
Granted | |
| 21,004 | | |
| 19.00 | |
Exercised | |
| (472 | ) | |
| 2.92 | |
Cancelled
/ Forfeited | |
| (944 | ) | |
| 19.00 | |
Balance
– June 30, 2023 | |
| 84,323 | | |
| 20.46 | |
|
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v3.24.2.u1
Supplemental disclosure of cash flow information (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Notes and other explanatory information [abstract] |
|
Summary of changes in operating assets and liabilities |
Summary of changes in operating assets and liabilities
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three
months ended | | |
Six
months ended | |
| |
June
30, | | |
June
30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| $ | | |
| $ | | |
| $ | | |
| $ | |
Changes in operating assets
and liabilities: | |
| | | |
| | | |
| | | |
| | |
Trade
and other receivables | |
| 427 | | |
| 987 | | |
| (684 | ) | |
| 927 | |
Inventory | |
| 501 | | |
| (673 | ) | |
| 894 | | |
| (1,034 | ) |
Prepaid
expenses and other current assets | |
| 368 | | |
| 51 | | |
| 248 | | |
| 26 | |
Payables
and accrued liabilities | |
| 565 | | |
| (488 | ) | |
| 442 | | |
| (966 | ) |
Provision
for restructuring and other costs | |
| 1 | | |
| - | | |
| 1 | | |
| - | |
Employee
future benefits | |
| (44 | ) | |
| - | | |
| (44 | ) | |
| - | |
Increase
(decrease) in operating assets and liabilities | |
| 1,818 | | |
| (123 | ) | |
| 857 | | |
| (1,047 | ) |
|
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v3.24.2.u1
Net loss per share (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Notes and other explanatory information [abstract] |
|
Summary of pertinent data relating to computation of basic and diluted net loss per share |
The
following table sets forth pertinent data relating to the computation of basic and diluted net loss per share attributable to common
shareholders.
Summary of pertinent data relating to computation of basic and diluted net loss per share
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three
months ended | | |
Six
months ended | |
| |
June
30, | | |
June
30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| $ | | |
| $ | | |
| $ | | |
| $ | |
Net
loss | |
| (1,422 | ) | |
| (860 | ) | |
| (2,823 | ) | |
| (1,145 | ) |
Basic and diluted weighted-average
shares outstanding | |
| 2,220,303 | | |
| 1,846,775 | | |
| 2,033,539 | | |
| 1,846,759 | |
| |
| | | |
| | | |
| | | |
| | |
Basic and
diluted loss per share | |
| (0.64 | ) | |
| (0.47 | ) | |
| (1.39 | ) | |
| (0.62 | ) |
| |
| | | |
| | | |
| | | |
| | |
Items excluded from the calculation
of diluted net loss per share due to their anti-dilutive effect: | |
| | | |
| | | |
| | | |
| | |
Stock options and DSUs | |
| 130,108 | | |
| 84,323 | | |
| 130,108 | | |
| 84,323 | |
Warrants | |
| 747,948 | | |
| - | | |
| 747,948 | | |
| - | |
|
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v3.24.2.u1
Segment information (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Notes and other explanatory information [abstract] |
|
Summary relevant financial information by operating segment |
The
table below summarizes the relevant financial information by operating segment:
Summary relevant financial information by operating segment
| |
Active
ingredient | | |
Biopharmaceutical | | |
Total | |
| |
Three
months ended June 30, 2024 | |
| |
Active
ingredient | | |
Biopharmaceutical | | |
Total | |
| |
| $ | | |
| $ | | |
| $ | |
Revenue | |
| 2,334 | | |
| 3 | | |
| 2,337 | |
Cost of sales | |
| (1,514 | ) | |
| (4 | ) | |
| (1,518 | ) |
Gross margin | |
| 820 | | |
| (1 | ) | |
| 819 | |
Research
and development | |
| (782 | ) | |
| (748 | ) | |
| (1,530 | ) |
Loss
from operations before SG&A and other income (expenses) | |
| 38 | | |
| (749 | ) | |
| (711 | ) |
Selling,
general & administrative | |
| | | |
| | | |
| (3,044 | ) |
Loss
from operations | |
| | | |
| | | |
| (3,755 | ) |
Net
other income | |
| | | |
| | | |
| 1,859 | |
Loss
before income taxes | |
| | | |
| | | |
| (1,896 | ) |
| |
Active
ingredient | | |
Biopharmaceutical | | |
Total | |
| |
Three
months ended June 30, 2023 | |
| |
Active
ingredient | | |
Biopharmaceutical | | |
Total | |
| |
| $ | | |
| $ | | |
| $ | |
Revenue | |
| 1,392 | | |
| - | | |
| 1,392 | |
Cost of sales | |
| (595 | ) | |
| - | | |
| (595 | ) |
Gross margin | |
| 797 | | |
| - | | |
| 797 | |
Research
and development | |
| (691 | ) | |
| - | | |
| (691 | ) |
Income
from operations before SG&A and other income (expenses) | |
| 106 | | |
| - | | |
| 106 | |
Selling,
general & administrative | |
| | | |
| | | |
| (1,220 | ) |
Loss
from operations | |
| | | |
| | | |
| (1,114 | ) |
Net
other income | |
| | | |
| | | |
| 19 | |
Loss
before income taxes | |
| | | |
| | | |
| (1,095 | ) |
COSCIENS
Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
| |
Active
ingredient | | |
Biopharmaceutical | | |
Total | |
| |
Six
months ended June 30, 2024 | |
| |
Active
ingredient | | |
Biopharmaceutical | | |
Total | |
| |
| $ | | |
| $ | | |
| $ | |
Revenue | |
| 4,391 | | |
| 3 | | |
| 4,394 | |
Cost of sales | |
| (2,667 | ) | |
| (4 | ) | |
| (2,671 | ) |
Gross margin | |
| 1,724 | | |
| (1 | ) | |
| 1,723 | |
Research
and development | |
| (1,844 | ) | |
| (748 | ) | |
| (2,592 | ) |
Loss
from operations before SG&A and other income (expenses) | |
| (120 | ) | |
| (749 | ) | |
| (869 | ) |
Selling,
general & administrative | |
| | | |
| | | |
| (4,710 | ) |
Loss
from operations | |
| | | |
| | | |
| (5,579 | ) |
Net
other income | |
| | | |
| | | |
| 1,870 | |
Loss
before income taxes | |
| | | |
| | | |
| (3,709 | ) |
| |
Active
ingredient | | |
Biopharmaceutical | | |
Total | |
| |
Six
months ended June 30, 2023 | |
| |
Active
ingredient | | |
Biopharmaceutical | | |
Total | |
| |
| $ | | |
| $ | | |
| $ | |
Revenue | |
| 3,977 | | |
| - | | |
| 3,977 | |
Cost of sales | |
| (1,992 | ) | |
| - | | |
| (1,992 | ) |
Gross margin | |
| 1,985 | | |
| - | | |
| 1,985 | |
Research
and development | |
| (1,115 | ) | |
| - | | |
| (1,115 | ) |
Income
from operations before SG&A and other income (expenses) | |
| 870 | | |
| - | | |
| 870 | |
Income
(Loss) from operations before SG&A and other income (expenses) | |
| 870 | | |
| - | | |
| 870 | |
Selling,
general & administrative | |
| | | |
| | | |
| (2,352 | ) |
Loss
from operations | |
| | | |
| | | |
| (1,482 | ) |
Net
other income | |
| | | |
| | | |
| 24 | |
Loss
before income taxes | |
| | | |
| | | |
| (1,458 | ) |
|
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Schedule of purchase price to the fair values of assets acquired and liabilities assumed (Details) - USD ($) $ in Thousands |
Jun. 30, 2024 |
Jun. 03, 2024 |
Mar. 31, 2024 |
Dec. 31, 2023 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Dec. 31, 2022 |
IfrsStatementLineItems [Line Items] |
|
|
|
|
|
|
|
|
Purchase price, amount |
|
|
$ 4,081
|
|
|
|
|
|
Cash and cash equivalents |
|
$ 27,804
|
|
$ 3,506
|
$ 6,678
|
$ 8,538
|
$ 9,295
|
$ 10,190
|
Prepaid expenses and deposits |
|
$ 4
|
|
|
$ 81
|
|
|
|
Aeterna zentaris inc [member] |
|
|
|
|
|
|
|
|
IfrsStatementLineItems [Line Items] |
|
|
|
|
|
|
|
|
Shares deemed issued to Aeterna shareholders, shares |
[1] |
|
1,213,967
|
|
|
|
|
|
Shares deemed issued to Aeterna shareholders, amount |
[1] |
|
$ 8,485
|
|
|
|
|
|
Warrants issued to Aeterna shareholders, shares |
[2] |
|
633,543
|
|
|
|
|
|
Warrants issued to Aeterna shareholders, amount |
[2] |
|
$ 4,422
|
|
|
|
|
|
Equity-settled options, shares |
[3] |
|
12,949
|
|
|
|
|
|
Equity-settled options, amount |
[3] |
|
$ 9
|
|
|
|
|
|
Cash-settled DSUs, shares |
[3] |
|
49,230
|
|
|
|
|
|
Cash-settled DSUs, amount |
[3] |
|
$ 344
|
|
|
|
|
|
Warrants deemed issued, shares |
[4] |
|
114,405
|
|
|
|
|
|
Warrants deemed issued, amount |
[4] |
|
$ 2
|
|
|
|
|
|
Purchase price |
[1] |
|
2,024,094
|
|
|
|
|
|
Purchase price, amount |
[1] |
|
$ 13,262
|
|
|
|
|
|
Cash and cash equivalents |
|
|
26,037
|
|
|
|
|
|
Trade and other receivables |
|
|
142
|
|
|
|
|
|
Inventories |
|
|
64
|
|
|
|
|
|
Income tax receivables |
|
|
119
|
|
|
|
|
|
Prepaid expenses and deposits |
|
|
971
|
|
|
|
|
|
Restricted cash equivalents |
|
|
328
|
|
|
|
|
|
Property and equipment |
|
|
235
|
|
|
|
|
|
Intangible assets |
[5] |
|
3,352
|
|
|
|
|
|
Accounts payable and accrued liabilities |
|
|
(4,357)
|
|
|
|
|
|
Provisions |
|
|
(424)
|
|
|
|
|
|
Income tax payable |
|
|
(109)
|
|
|
|
|
|
Deferred revenues |
|
|
(1,731)
|
|
|
|
|
|
Lease liabilities |
|
|
(201)
|
|
|
|
|
|
Employee future benefits |
|
|
(11,164)
|
|
|
|
|
|
Total provisional identifiable net assets (liabilities) |
|
|
$ 13,262
|
|
|
|
|
|
|
|
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Schedule of purchase price to the fair values of assets acquired and liabilities assumed (Details) (Paranthetical)
|
|
6 Months Ended |
|
Jun. 03, 2024
$ / shares
shares
|
Jun. 30, 2024 |
Jun. 03, 2024
$ / shares
shares
|
Patents [member] |
|
|
|
|
IfrsStatementLineItems [Line Items] |
|
|
|
|
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|
|
expiring between 2027
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|
|
Aeterna zentaris inc [member] |
|
|
|
|
IfrsStatementLineItems [Line Items] |
|
|
|
|
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1,213,967
|
|
1,213,967
|
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|
$ 6.99
|
|
$ 0.225
|
Exchanged price per share | $ / shares |
|
$ 0.02360
|
|
|
Warrants issued |
[2] |
633,543
|
|
633,543
|
Warrants deemed issued |
[3] |
114,405
|
|
114,405
|
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|
|
|
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|
$ 6.99
|
|
$ 0.225
|
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|
$ 0.02360
|
|
|
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|
633,543
|
|
633,543
|
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|
$ 0.01
|
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v3.24.2.u1
Summary of revenue from transfer of goods and services (Details) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Notes and other explanatory information [abstract] |
|
|
|
|
Active ingredients |
$ 2,334
|
$ 1,392
|
$ 4,391
|
$ 3,977
|
Pharmaceutical |
3
|
|
3
|
|
Total |
$ 2,337
|
$ 1,392
|
$ 4,394
|
$ 3,977
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Acquisition of Aeterna Zentaris Inc. (Details Narrative) $ / shares in Units, $ in Thousands |
|
1 Months Ended |
3 Months Ended |
6 Months Ended |
|
Jun. 03, 2024
USD ($)
$ / shares
|
Jun. 30, 2024
USD ($)
|
Jun. 30, 2024
USD ($)
|
Jun. 30, 2023
USD ($)
|
Jun. 30, 2024
USD ($)
|
Jun. 30, 2023
USD ($)
|
Jun. 03, 2024
$ / shares
|
IfrsStatementLineItems [Line Items] |
|
|
|
|
|
|
|
|
Revenue |
|
|
|
$ 2,337
|
$ 1,392
|
$ 4,394
|
$ 3,977
|
|
Net loss |
|
|
|
$ (1,422)
|
$ (860)
|
$ (2,823)
|
$ (1,145)
|
|
Acquisition-related costs |
|
$ 4,081
|
|
|
|
|
|
|
Aeterna zentaris inc [member] |
|
|
|
|
|
|
|
|
IfrsStatementLineItems [Line Items] |
|
|
|
|
|
|
|
|
Fair value of the replacement awards |
|
356
|
|
|
|
|
|
|
Equity-settled options, amount |
[1] |
9
|
|
|
|
|
|
|
Cash-settled DSUs, amount |
[1] |
344
|
|
|
|
|
|
|
Post-acquisition compensation cost |
|
$ 3
|
|
|
|
|
|
|
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|
$ 6.99
|
|
|
|
|
|
|
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|
6.99
|
|
|
|
|
|
$ 0.225
|
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|
$ 0.02360
|
|
|
|
|
|
|
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|
|
$ 3
|
|
|
|
|
|
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|
|
$ 214
|
|
|
|
|
|
Description of acquisition |
|
If the
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date of acquisition would have been the same if the acquisition had occurred on January 1, 2024.
|
|
|
|
|
|
|
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[2] |
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|
|
|
|
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Schedule of property and equipment (Details) - USD ($) $ in Thousands |
6 Months Ended |
12 Months Ended |
Jun. 30, 2024 |
Dec. 31, 2023 |
IfrsStatementLineItems [Line Items] |
|
|
Property plant and equipment, Beginning |
$ 11,645
|
|
Property plant and equipment, Ending |
11,499
|
$ 11,645
|
Equipment not available for use [member] |
|
|
IfrsStatementLineItems [Line Items] |
|
|
Property plant and equipment, Beginning |
2,199
|
|
Property plant and equipment, Ending |
2,822
|
2,199
|
Equipments [Member] |
|
|
IfrsStatementLineItems [Line Items] |
|
|
Property plant and equipment, Beginning |
3,911
|
|
Property plant and equipment, Ending |
3,607
|
3,911
|
Office equipment [member] |
|
|
IfrsStatementLineItems [Line Items] |
|
|
Property plant and equipment, Beginning |
104
|
|
Property plant and equipment, Ending |
112
|
104
|
Buildings [member] |
|
|
IfrsStatementLineItems [Line Items] |
|
|
Property plant and equipment, Beginning |
1,481
|
|
Property plant and equipment, Ending |
1,372
|
1,481
|
Leasehold improvements [member] |
|
|
IfrsStatementLineItems [Line Items] |
|
|
Property plant and equipment, Beginning |
3,950
|
|
Property plant and equipment, Ending |
3,586
|
3,950
|
Gross carrying amount [member] |
|
|
IfrsStatementLineItems [Line Items] |
|
|
Property plant and equipment, Beginning |
21,449
|
20,538
|
Additions |
721
|
857
|
Disposals |
|
(438)
|
Impact of foreign exchange rate changes |
(713)
|
492
|
Acquisition of Aeterna (note 3) |
235
|
|
Property plant and equipment, Ending |
21,692
|
21,449
|
Gross carrying amount [member] | Equipment not available for use [member] |
|
|
IfrsStatementLineItems [Line Items] |
|
|
Property plant and equipment, Beginning |
2,199
|
1,462
|
Additions |
700
|
683
|
Disposals |
|
|
Impact of foreign exchange rate changes |
(77)
|
54
|
Acquisition of Aeterna (note 3) |
|
|
Property plant and equipment, Ending |
2,822
|
2,199
|
Gross carrying amount [member] | Equipments [Member] |
|
|
IfrsStatementLineItems [Line Items] |
|
|
Property plant and equipment, Beginning |
9,059
|
9,223
|
Additions |
6
|
68
|
Disposals |
|
(438)
|
Impact of foreign exchange rate changes |
(294)
|
206
|
Acquisition of Aeterna (note 3) |
124
|
|
Property plant and equipment, Ending |
8,895
|
9,059
|
Gross carrying amount [member] | Office equipment [member] |
|
|
IfrsStatementLineItems [Line Items] |
|
|
Property plant and equipment, Beginning |
717
|
681
|
Additions |
3
|
20
|
Disposals |
|
|
Impact of foreign exchange rate changes |
(26)
|
16
|
Acquisition of Aeterna (note 3) |
23
|
|
Property plant and equipment, Ending |
717
|
717
|
Gross carrying amount [member] | Buildings [member] |
|
|
IfrsStatementLineItems [Line Items] |
|
|
Property plant and equipment, Beginning |
2,794
|
2,730
|
Additions |
|
|
Disposals |
|
|
Impact of foreign exchange rate changes |
(99)
|
64
|
Acquisition of Aeterna (note 3) |
88
|
|
Property plant and equipment, Ending |
2,783
|
2,794
|
Gross carrying amount [member] | Leasehold improvements [member] |
|
|
IfrsStatementLineItems [Line Items] |
|
|
Property plant and equipment, Beginning |
6,680
|
6,442
|
Additions |
12
|
86
|
Disposals |
|
|
Impact of foreign exchange rate changes |
(217)
|
152
|
Acquisition of Aeterna (note 3) |
|
|
Property plant and equipment, Ending |
6,475
|
6,680
|
Accumulated depreciation [member] |
|
|
IfrsStatementLineItems [Line Items] |
|
|
Property plant and equipment, Beginning |
9,804
|
8,584
|
Disposals |
|
(438)
|
Impact of foreign exchange rate changes |
(323)
|
217
|
Property plant and equipment, Ending |
10,193
|
9,804
|
Amortization |
712
|
1,441
|
Accumulated depreciation [member] | Equipment not available for use [member] |
|
|
IfrsStatementLineItems [Line Items] |
|
|
Property plant and equipment, Beginning |
|
|
Disposals |
|
|
Impact of foreign exchange rate changes |
|
|
Property plant and equipment, Ending |
|
|
Amortization |
|
|
Accumulated depreciation [member] | Equipments [Member] |
|
|
IfrsStatementLineItems [Line Items] |
|
|
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5,148
|
4,842
|
Disposals |
|
(438)
|
Impact of foreign exchange rate changes |
(167)
|
114
|
Property plant and equipment, Ending |
5,288
|
5,148
|
Amortization |
307
|
630
|
Accumulated depreciation [member] | Office equipment [member] |
|
|
IfrsStatementLineItems [Line Items] |
|
|
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613
|
565
|
Disposals |
|
|
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(22)
|
14
|
Property plant and equipment, Ending |
605
|
613
|
Amortization |
14
|
34
|
Accumulated depreciation [member] | Buildings [member] |
|
|
IfrsStatementLineItems [Line Items] |
|
|
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1,313
|
997
|
Disposals |
|
|
Impact of foreign exchange rate changes |
(44)
|
29
|
Property plant and equipment, Ending |
1,411
|
1,313
|
Amortization |
142
|
287
|
Accumulated depreciation [member] | Leasehold improvements [member] |
|
|
IfrsStatementLineItems [Line Items] |
|
|
Property plant and equipment, Beginning |
2,730
|
2,180
|
Disposals |
|
|
Impact of foreign exchange rate changes |
(90)
|
60
|
Property plant and equipment, Ending |
2,889
|
2,730
|
Amortization |
$ 249
|
$ 490
|
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Schedule of Intangible Assets (Details) - USD ($) $ in Thousands |
6 Months Ended |
12 Months Ended |
Jun. 30, 2024 |
Dec. 31, 2023 |
Notes and other explanatory information [abstract] |
|
|
Intangible assets other than goodwill, cost beginning |
$ 34
|
$ 33
|
Intangible assets other than goodwill, accumulated amortization, beginning |
(27)
|
(24)
|
Intangible assets other than goodwill, beginning |
7
|
9
|
Business acquisition, cost |
3,352
|
|
Business acquisition, accumulated amortization |
|
|
Business acquisition |
3,352
|
|
Amortization cost |
|
|
Accumulated amortization |
(24)
|
(3)
|
Amortization |
(24)
|
(3)
|
Impact of foregin exchange rate changes cost |
1
|
1
|
Impact of foregin exchange rate changes accumulated amortization |
(1)
|
|
Impact of foregin exchange rate changes |
|
1
|
Intangible assets other than goodwill, cost ending |
3,387
|
34
|
Intangible assets other than goodwill, accumulated amortization,ending |
(52)
|
(27)
|
Intangible assets other than goodwill, ending |
$ 3,335
|
$ 7
|
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Summary of net employee future benefit liability asset (Details) $ in Thousands |
6 Months Ended |
Jun. 30, 2024
USD ($)
|
Change in plan liabilities |
|
Balances – Beginning of the period |
|
Acquisition of Aeterna (note 3) |
22,136
|
Current service cost |
11
|
Interest cost |
66
|
Actuarial gain from changes in financial assumptions |
|
Benefits paid |
(61)
|
Impact of foreign exchange rate changes |
(273)
|
Balances – End of the period |
21,879
|
Change in plan assets |
|
Balances – Beginning of the period |
|
Acquisition of Aeterna Zentaris Inc. (note 3) |
10,972
|
Interest income from plan assets |
33
|
Employer contributions |
3
|
Employee contributions |
1
|
Benefits paid |
(21)
|
Impact of foreign exchange rate changes |
(136)
|
Balances – End of the period |
10,852
|
Net liability of the unfunded plans |
10,816
|
Net liability of the funded plans |
211
|
Net amount recognized as Employee future benefits |
11,027
|
Amounts recognized: |
|
In net loss |
43
|
Actuarial gain on defined benefit plans in other comprehensive loss |
|
Pension defined benefit plans [member] |
|
Change in plan liabilities |
|
Balances – Beginning of the period |
|
Acquisition of Aeterna (note 3) |
22,036
|
Current service cost |
10
|
Interest cost |
66
|
Actuarial gain from changes in financial assumptions |
|
Benefits paid |
(61)
|
Impact of foreign exchange rate changes |
(271)
|
Balances – End of the period |
21,780
|
Change in plan assets |
|
Balances – Beginning of the period |
|
Acquisition of Aeterna Zentaris Inc. (note 3) |
10,972
|
Interest income from plan assets |
33
|
Employer contributions |
3
|
Employee contributions |
1
|
Benefits paid |
(21)
|
Impact of foreign exchange rate changes |
(136)
|
Balances – End of the period |
10,852
|
Net liability of the unfunded plans |
10,717
|
Net liability of the funded plans |
211
|
Net amount recognized as Employee future benefits |
10,928
|
Amounts recognized: |
|
In net loss |
42
|
Actuarial gain on defined benefit plans in other comprehensive loss |
|
Other benefit plans [member] |
|
Change in plan liabilities |
|
Balances – Beginning of the period |
|
Acquisition of Aeterna (note 3) |
100
|
Current service cost |
1
|
Interest cost |
|
Actuarial gain from changes in financial assumptions |
|
Benefits paid |
|
Impact of foreign exchange rate changes |
(2)
|
Balances – End of the period |
99
|
Change in plan assets |
|
Balances – Beginning of the period |
|
Acquisition of Aeterna Zentaris Inc. (note 3) |
|
Interest income from plan assets |
|
Employer contributions |
|
Employee contributions |
|
Benefits paid |
|
Impact of foreign exchange rate changes |
|
Balances – End of the period |
|
Net liability of the unfunded plans |
99
|
Net liability of the funded plans |
|
Net amount recognized as Employee future benefits |
99
|
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|
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1
|
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v3.24.2.u1
Property and equipment (Details Narrative) € in Thousands, $ in Thousands |
6 Months Ended |
12 Months Ended |
|
Jun. 30, 2024
USD ($)
|
Jun. 30, 2024
EUR (€)
|
Dec. 31, 2023
USD ($)
|
Jun. 30, 2024
EUR (€)
|
IfrsStatementLineItems [Line Items] |
|
|
|
|
Right-of-use, net carrying amount of property and equipment |
$ 1,372
|
|
$ 1,481
|
|
Payments of purchase carrying amount of equipment |
947
|
€ 1,015
|
|
|
Remaining purchase commitment |
678
|
|
|
€ 727
|
Leasehold improvements [member] |
|
|
|
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IfrsStatementLineItems [Line Items] |
|
|
|
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800
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|
800
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Equipment not available for use [member] |
|
|
|
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IfrsStatementLineItems [Line Items] |
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|
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$ 2,822
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$ 2,199
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v3.24.2.u1
v3.24.2.u1
Summary of warrants activity reclassified equity (Details) $ / shares in Units, $ in Thousands |
6 Months Ended |
Jun. 30, 2024
USD ($)
$ / shares
shares
|
Warrants |
|
Warrants outstanding, Beginning of year | shares |
|
Weighted average exercise price, beginning of year | $ / shares |
|
Warrants outstanding, beginning of year, value | $ |
|
Warrants either issued or assumed as part of the acquisition of Aeterna | shares |
747,948
|
Weighted average exercise price, Warrants either issued or assumed as part of the acquisition of Aeterna | $ / shares |
$ 13.32
|
Warrants either issued or assumed as part of the acquisition of Aeterna, value | $ |
$ 4,424
|
Change in fair value of warrants | shares |
|
Weighted average exercise price, Change in fair value of warrants | $ / shares |
|
Change in fair value of warrants, value | $ |
$ (1,628)
|
Warrants Outstanding, Ending of year | shares |
747,948
|
Weighted average exercise price, ending of year | $ / shares |
$ 13.32
|
Warrants outstanding, ending of year, value | $ |
$ 2,796
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v3.24.2.u1
Schedule of warrants outstanding (Details)
|
6 Months Ended |
Jun. 30, 2024
$ / shares
shares
|
IfrsStatementLineItems [Line Items] |
|
Options outstanding, Number (in shares) | shares |
747,948
|
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|
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$ 13.32
|
Warrants [member] | September 2019 [member] |
|
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|
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13,249
|
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2 months 26 days
|
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$ 165.00
|
Warrants [member] | February 2020 [member] |
|
IfrsStatementLineItems [Line Items] |
|
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11,129
|
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|
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$ 129.12
|
Warrants [member] | July 2020 [member] |
|
IfrsStatementLineItems [Line Items] |
|
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56,210
|
Options outstanding, Weighted average remaining contractual life (years) |
1 year 3 days
|
Options outstanding, Weighted average exercise price | $ / shares |
$ 45.00
|
Warrants [member] | August 2020 [member] |
|
IfrsStatementLineItems [Line Items] |
|
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17,310
|
Options outstanding, Weighted average remaining contractual life (years) |
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|
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$ 47.00
|
Warrants [member] | February 2021 [member] |
|
IfrsStatementLineItems [Line Items] |
|
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1 year 7 months 20 days
|
Options outstanding, Weighted average exercise price | $ / shares |
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|
Options outstanding, Number (in shares) | shares |
16,507
|
Warrants [member] | June 2024 [member] |
|
IfrsStatementLineItems [Line Items] |
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|
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|
Options outstanding, Weighted average exercise price | $ / shares |
$ 0.01
|
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v3.24.2.u1
Summary of number and weighted average exercise prices of deferred shares units (Details)
|
6 Months Ended |
Jun. 30, 2024
shares
$ / shares
|
Jun. 30, 2023
shares
$ / shares
|
IfrsStatementLineItems [Line Items] |
|
|
Number of Options, Beginning |
74,371
|
64,735
|
Number of Options, Granted - Replacement options |
12,949
|
21,004
|
Number of Options, Ending |
80,878
|
84,323
|
Weighted average exercise price, beginning | $ / shares |
$ 20.74
|
$ 20.46
|
Weighted average exercise price, granted - Replacement options | $ / shares |
$ 50.65
|
$ 19.00
|
Number of Options, Canceled/Forfeited |
(6,442)
|
(944)
|
Weighted average exercise price, canceled/forfeited | $ / shares |
$ 12.07
|
$ 19.00
|
Weighted average exercise price, ending | $ / shares |
$ 26.22
|
$ 20.46
|
Number of Options, Exercised |
|
(472)
|
Weighted average exercise price, exercised | $ / shares |
|
$ 2.92
|
Deferred share unit [member] |
|
|
IfrsStatementLineItems [Line Items] |
|
|
Number of Options, Beginning |
|
|
Beginning value |
|
|
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49,230
|
|
Granted - Replacement awards, value |
344
|
|
Number of Options, Change in fair value of DSUs |
|
|
Change in fair value of DSUs, value |
(127)
|
|
Number of Options, Ending |
49,230
|
|
Ending, value |
217
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v3.24.2.u1
Summary of share capital (Details) $ in Thousands |
6 Months Ended |
Jun. 30, 2024
USD ($)
shares
|
IfrsStatementLineItems [Line Items] |
|
Balance |
$ 21,035
|
Balance |
$ 26,227
|
Issued capital [member] |
|
IfrsStatementLineItems [Line Items] |
|
Number of shares issued | shares |
1,847,593
|
Balance |
$ 13,517
|
Issuance of common shares, net of transaction costs, shares | shares |
1,213,967
|
Beginning balance, Amount |
$ 8,485
|
Ending balance, shares | shares |
3,061,560
|
Balance |
$ 22,002
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v3.24.2.u1
Summary of pertinent data relating to computation of basic and diluted net loss per share (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
IfrsStatementLineItems [Line Items] |
|
|
|
|
Net loss |
$ (1,422)
|
$ (860)
|
$ (2,823)
|
$ (1,145)
|
Basic weighted-average number of shares outstanding |
2,220,303
|
1,846,775
|
2,033,539
|
1,846,759
|
Diluted weighted-average number of shares outstanding |
2,220,303
|
1,846,775
|
2,033,539
|
1,846,759
|
Basic loss per share |
$ (0.64)
|
$ (0.47)
|
$ (1.39)
|
$ (0.62)
|
Diluted loss per share |
$ (0.64)
|
$ (0.47)
|
$ (1.39)
|
$ (0.62)
|
Employee stock option1 deferred stock units [member] |
|
|
|
|
Items excluded from the calculation of diluted net loss per share due to their anti-dilutive effect: |
|
|
|
|
Warrants |
130,108
|
84,323
|
130,108
|
84,323
|
Warrants [member] |
|
|
|
|
Items excluded from the calculation of diluted net loss per share due to their anti-dilutive effect: |
|
|
|
|
Warrants |
747,948
|
|
747,948
|
|
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v3.24.2.u1
Summary relevant financial information by operating segment (Details) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
IfrsStatementLineItems [Line Items] |
|
|
|
|
Revenue |
$ 2,337
|
$ 1,392
|
$ 4,394
|
$ 3,977
|
Cost of sales |
(1,518)
|
(595)
|
(2,671)
|
(1,992)
|
Gross profit |
819
|
797
|
1,723
|
1,985
|
Research and development |
(1,530)
|
(691)
|
(2,592)
|
(1,115)
|
Income (Loss) from operations before SG&A and other income (expenses) |
(711)
|
106
|
(869)
|
870
|
Selling, general & administrative |
(3,044)
|
(1,220)
|
(4,710)
|
(2,352)
|
Loss from operations |
(3,755)
|
(1,114)
|
(5,579)
|
(1,482)
|
Net other income |
1,859
|
19
|
1,870
|
24
|
Loss before income taxes |
(1,896)
|
(1,095)
|
(3,709)
|
(1,458)
|
Loss from operations |
(3,755)
|
(1,114)
|
(5,579)
|
(1,482)
|
Active ingredient [member] |
|
|
|
|
IfrsStatementLineItems [Line Items] |
|
|
|
|
Revenue |
2,334
|
1,392
|
4,391
|
3,977
|
Cost of sales |
(1,514)
|
(595)
|
(2,667)
|
(1,992)
|
Gross profit |
820
|
797
|
1,724
|
1,985
|
Research and development |
(782)
|
(691)
|
(1,844)
|
(1,115)
|
Income (Loss) from operations before SG&A and other income (expenses) |
38
|
106
|
(120)
|
870
|
Biopharmaceutical [member] |
|
|
|
|
IfrsStatementLineItems [Line Items] |
|
|
|
|
Revenue |
3
|
|
3
|
|
Cost of sales |
(4)
|
|
(4)
|
|
Gross profit |
(1)
|
|
(1)
|
|
Research and development |
(748)
|
|
(748)
|
|
Income (Loss) from operations before SG&A and other income (expenses) |
$ (749)
|
|
$ (749)
|
|
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