Novoheart Holdings Inc. (“Novoheart” or the “Company”) reports
financial results for the three and six months ended June 30, 2020.
Amounts, unless specified otherwise, are expressed in Canadian
dollars and are in accordance with International Financial
Reporting Standards (IFRS).
Business
Highlights:
- Patent application filed on
next-generation “human
heart-in-a-jar” bioreactor
- Successful completion of a commercial contract
with a top-20 pharmaceutical company
- Assessed the cardiac safety of a proposed
COVID-19 treatment
- Soft opening of Novoheart’s newly renovated
research lab and office in Hong Kong
- Awarded the outstanding Biomedical Technology
Award in the 2020 CAPITAL Outstanding Enterprise
Awards
Patent application filed on
next-generation “human
heart-in-a-jar” bioreactor
In June 2020, the Company filed a US Provisional
patent application on a next-generation bioreactor for the “human
heart-in-a-jar” with multiple important new features that were not
available in previous versions. With the new design, this
next-generation bioreactor will provide finer control of mini-heart
chamber properties, crucial for human models of cardiac diseases.
The additional disease modelling capabilities will attract drug
developers given the industry-wide demand for a reliable,
human-specific model to test the safety and efficacy of new
therapeutic candidates.
Successful completion of a
commercial contract with a top-20 pharmaceutical
company
In April 2020, Novoheart completed its
commercial agreement with a top-20 pharmaceutical company utilizing
the company’s human ventricular Cardiac Tissue Strips (hvCTS) to
study the effects of blinded drugs on cardiac contractility.
Assessed the cardiac safety of a
proposed COVID-19 treatment on cardiac contractility and
arrhythmogenicity
Novoheart completed a study in May 2020 using
our human engineered cardiac constructs to investigate the effects
of hydroxychloroquine and azithromycin on contractility and
arrhythmogenicity in human hearts. Our engineered cardiac
constructs provided a useful platform for screening cardiac safety
and efficacy when developing therapeutics against COVID-19.
Soft opening of Novoheart’s
newly renovated research lab and office in Hong
Kong
On June 22, 2020, the Company had its soft
launch opening of the newly renovated research lab and office in
Hong Kong. The site houses the Company’s state-of-the-art research
facility with a bigger office and laboratory. The facility will
provide much-needed space to accommodate our growth and enables us
to hire additional talent to continue to provide industry-leading
service to our global clients.
Awarded the outstanding
Biomedical Technology Award in the 2020 CAPITAL Outstanding
Enterprise Awards The CAPITAL Outstanding
Enterprise Awards are one of the most recognized enterprise awards
in Hong Kong, with the aim to acknowledge enterprises which have
outstanding performance and achievement during the year. Novoheart
was delighted that its revolutionary technologies had earned
recognition among the Hong Kong business community.
Financial Results for the three
and six months ended June 30, 2020
The Company recorded a net loss after tax of
$1,901,944 (loss per share of $0.01) for the three months ended
June 30, 2020 compared to a net loss after tax of $2,582,062 (loss
per share of $0.03) for the three months ended June 30, 2019. On a
year-to-date basis, the Company recorded a net loss of $4,738,984
(loss per share of $0.03) for the six months ended June 30, 2020
compare to a net loss of $3,761,260 (loss per share of $0.04) for
the six months ended June 30, 2019.
Revenue and Cost of Sales
For the three months ended June 30, 2020, the
Company recorded revenue of $39,662 and cost of sales of $17,683
compared to revenue of $51,821 and cost of sales of $24,620 for the
three months ended June 30, 2019. The Company recorded revenue of
$49,782 and cost of sales of $21,537 for the six months ended June
30, 2020 compared to revenue of $159,776 and cost of sales of
$73,743 for the six months ended June 30, 2019. Starting in March
2020, COVID-19 has a global impact which impacted a number of the
Company’s partners. The impact continued to be felt by Novoheart
and its partners throughout Q2 2020, causing delays in
communication and contract execution.
Operating Expenses
Operating expenses decreased from $2,611,560 for
the three months ended June 30, 2019 to $2,411,107 for the three
months ended June 30, 2020. The decrease in operating expenses
primarily relates to depreciation expense, share-based compensation
expense, general and administration expense, and marketing expense.
The decrease was offset by increases in research and development
expense, and intellectual and patent expenses.
During the three months ended June 30, 2020,
depreciation expense decreased due to the write-off of leasehold
improvements capitalized in Phase 3 of Hong Kong Science Park;
previously capitalized leasehold improvements were removed in order
to convert the space into a GMP facility. Share-based compensation
expense decreased because most of the Company’s options were vested
and recognized in previous periods. General and administrative
expenses decreased mainly due to expenses incurred in the
comparative quarter which were not in the current quarter;
specifically, bonuses to personnel and professional fees related to
the acquisition of Xellera Therapeutics Limited (the
“Acquisition”) in June 2019.
Marketing expenses decreased primarily due to the termination of
the Company’s former Senior Vice President of Commercial
Operations.
For the three months ended June 30, 2020
research and development expenses increased primarily due to the
expansion of the Company’s scientific team and the Acquisition
which was completed in June 2019. Intellectual property and patent
expense increased due to filing of new patents as well as licensing
agreements signed with Harvard University effective November
2019.
Operating expenses increased from $4,351,365 for
the six months ended June 30, 2019 to $5,059,344 for the six months
ended June 30, 2020. The increases in operating expenses is
primarily related to general and administrative expense, research
and development, and intellectual and patent expenses as compared
to the six months ended June 30, 2019. The increase was offset by
decreases in depreciation expense, share-based compensation
expense, and marketing expense.
The increase in general and administrative
expense for the six months ended June 30, 2020 is primarily due to
increases in occupancy cost as a result of the lab and office
expense and build-out of the GMP facility. Research and development
expense and intellectual property and patent expense increased
during the six months ended June 30, 2020 for the same reasons
noted above for the three months ended June 30, 2020.
The primary reasons for decreases in
depreciation expense, share-based compensation expense, and
marketing expenses for the six months ended June 30, 2020 are the
same reasons noted above for the three months ended June 30,
2020.
Liquidity and Outstanding Share
Capital
As at June 30, 2020, the Company had cash and
cash equivalents of $13,236,527. As at August 31, 2020, there were
188,640,774 common shares issued and outstanding, and 8,272,373
common shares issuable upon the exercise of outstanding stock
options at an exercise price range from $0.32 to $0.50 per
share.
Departure of Chief Scientific
Officer of Xellera Therapeutics Limited
During Q2 2020, Dr. Roger Hajjar resigned as
Chief Scientific Officer of Xellera Therapeutics Limited to take up
a position with a private equity-owned business focusing on
clinical research. Dr. Hajjar as CSO of XT contributed
significantly to the directions of clinical translation during the
early planning stage, particularly in the space of gene therapy, as
the foundation of XT. In the coming months, the focus will be on
the build out and regulatory licenses. Any scientific matters will
be shared by the cofounders Drs. Godfrey Chan and Ronald Li with
inputs from the Scientific Advisory Board co-chairs Drs. Marc
Turner and Paul Tam. The Company would like to thank Dr. Hajjar for
his contributions during his tenure and wishes him success in the
future.
Departure of Chief Research
Development Officer of Novoheart
Effective July 31, 2020, Dr. Bernard Fermini,
the Company’s Chief Research & Development Officer, tenured his
resignation. Dr. Fermini was recruited to assist the Scientific
Co-Founders Drs. Kevin Costa and Ronald Li in research and
development. His responsibilities have been transitioned to and
handled in part by Drs. Costa and Li who are also the Company’s
Chief Scientific Officer and Chief Executive Officer, respectively.
The Company would like to thank Dr. Fermini for his contributions
while serving as Chief Research & Development Officer.
ABOUT NOVOHEART HOLDINGS
INC.
Novoheart is a global stem cell biotechnology
company that pioneers an array of next-generation human heart
tissue prototypes. It is the first company in the world to have
engineered miniature living human heart pumps that can
revolutionize drug discovery, helping to save time and money for
developing new therapeutics. Also known as 'human heart-in-a-jar',
Novoheart’s bio-artificial human heart constructs are created using
state-of-the-art and proprietary stem cell and bioengineering
approaches and are utilized by drug developers for accurate
preclinical testing as to the effectiveness and safety of new
drugs, maximizing the successes in drug discovery while minimizing
costs and harm caused to patients. With the acquisition of Xellera
Therapeutics Limited for manufacturing Good Manufacturing Product
(GMP)-grade clinical materials, Novoheart is now developing gene-
and cell-based therapies as well as other next-generation
therapeutics for cardiac repair or regeneration.
Common shares of Novoheart are traded on the TSX
Venture Exchange under the symbol “NVH”.
For further information please
contact:
Novoheart Holdings Inc.Suite 2600, 595 Burrard
StreetVancouver, British ColumbiaV7X 1L3
Ronald LiChief Executive Officer
(604) 398-3170info@novoheart.com
Cautionary Note Regarding
Forward-Looking Statements
Information set forth in this news release may
involve forward-looking statements under applicable securities
laws. Forward-looking statements are statements that relate to
future, not past, events. In this context, forward-looking
statements often address expected future business and financial
performance, and often contain words such as "anticipate",
"believe", "plan", "estimate", "expect", and "intend", statements
that an action or event "may", "might", "could", "should", or
"will" be taken or occur, or other similar expressions. All
statements, other than statements of historical fact, included
herein including, without limitation; statements about the
Company’s future plans, its goals and expectations, and the
potential applications its MyHeart™ platform are
forward-looking statements. By their nature, forward-looking
statements involve known and unknown risks, uncertainties and other
factors which may cause the actual results, performance or
achievements, or other future events, to be materially different
from any future results, performance or achievements expressed or
implied by such forward-looking statements. Such factors include,
among others, the risks identified in the management discussion and
analysis section of Novoheart Holdings Inc.’s interim and most
recent annual financial statement or other reports and filings with
the TSX Venture Exchange and applicable Canadian securities
regulators. Forward-looking statements are made based on
management's beliefs, estimates and opinions on the date that
statements are made and the respective companies undertake no
obligation to update forward-looking statements if these beliefs,
estimates and opinions or other circumstances should change, except
as required by applicable securities laws. Investors are cautioned
against attributing undue certainty to forward-looking
statements.
NOVOHEART HOLDINGS
INC.Condensed Consolidated Interim Statements of
Financial Position (unaudited)(Expressed in Canadian dollars)
|
|
|
June
30,2020 |
|
|
December
31,2019 |
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
|
|
|
Current |
|
|
|
|
|
Cash and cash equivalents |
|
$ |
13,236,527 |
|
$ |
12,167,583 |
|
Pledged bank deposit |
|
|
- |
|
|
5,004,000 |
|
Accounts and other receivables |
|
|
82,236 |
|
|
317,819 |
|
Prepaid expenses and deposits |
|
|
311,392 |
|
|
475,638 |
|
|
|
|
13,630,155 |
|
|
17,965,040 |
|
|
|
|
|
|
|
Property and equipment, net |
|
|
691,083 |
|
|
532,589 |
|
Right-of-use assets |
|
|
6,570,247 |
|
|
6,996,852 |
|
Intangible assets, net |
|
|
199,599 |
|
|
231,052 |
|
Construction in progress |
|
|
774,800 |
|
|
- |
|
Goodwill |
|
|
8,806,998 |
|
|
8,806,998 |
|
|
|
|
|
|
|
|
|
$ |
30,672,882 |
|
$ |
34,532,531 |
|
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS'
EQUITY |
|
|
|
|
|
|
|
|
|
Current |
|
|
|
|
Accounts payable and accrued liabilities |
|
$ |
833,339 |
|
$ |
921,672 |
|
Lease liabilities – current |
|
|
1,298,489 |
|
|
1,124,678 |
|
Contract liabilities |
|
|
34,130 |
|
|
22,549 |
|
Deferred government grants |
|
|
58,265 |
|
|
8,253 |
|
Due to related parties |
|
|
- |
|
|
32,835 |
|
|
|
|
2,224,223 |
|
|
2,109,987 |
|
|
|
|
|
|
|
Lease liabilities –
non-current |
|
|
5,036,241 |
|
|
5,555,838 |
|
Restoration provision |
|
|
476,323 |
|
|
451,937 |
|
Long-term license payable |
|
|
- |
|
|
24,238 |
|
|
|
|
|
|
|
|
|
|
7,736,787 |
|
|
8,142,000 |
|
|
|
|
|
|
|
Shareholders' Equity |
|
|
|
|
|
Share capital |
|
|
52,179,118 |
|
|
52,179,118 |
|
Contributed surplus |
|
|
2,237,675 |
|
|
1,888,156 |
|
Accumulated other comprehensive income |
|
|
1,247,656 |
|
|
312,627 |
|
Accumulated deficit |
|
|
(32,728,354 |
) |
|
(27,989,370 |
) |
|
|
|
22,936,095 |
|
|
26,390,531 |
|
|
|
|
|
|
|
|
|
$ |
30,672,882 |
|
$ |
34,532,531 |
|
NOVOHEART HOLDINGS
INC.
Condensed Consolidated Interim Statements of
Loss and Comprehensive Loss (unaudited)(Expressed in Canadian
dollars, except number of common shares)
|
|
|
Three months
ended |
Six months
ended |
|
|
|
June
30, 2020 |
|
|
June 30, 2019 |
|
|
June 30, 2020 |
|
|
June 30, 2019 |
|
|
|
|
|
|
|
|
Revenue |
|
$ |
39,662 |
|
$ |
51,821 |
|
$ |
49,782 |
|
$ |
159,776 |
|
Cost of sales |
|
|
17,683 |
|
|
24,620 |
|
|
21,537 |
|
|
73,743 |
|
|
|
|
21,979 |
|
|
27,201 |
|
|
28,245 |
|
|
86,033 |
|
OPERATING EXPENSES |
|
|
|
|
|
|
Research and development |
|
|
773,233 |
|
|
709,039 |
|
|
1,498,650 |
|
|
1,241,717 |
|
Intellectual property and patent |
|
|
151,820 |
|
|
105,731 |
|
|
305,591 |
|
|
168,124 |
|
General and administrative |
|
|
1,160,648 |
|
|
1,235,148 |
|
|
2,445,491 |
|
|
1,812,283 |
|
Marketing |
|
|
134,775 |
|
|
175,221 |
|
|
280,443 |
|
|
342,486 |
|
Share-based compensation |
|
|
140,094 |
|
|
216,244 |
|
|
349,519 |
|
|
448,351 |
|
Depreciation and amortization |
|
|
50,537 |
|
|
170,177 |
|
|
179,650 |
|
|
338,404 |
|
|
|
|
2,411,107 |
|
|
2,611,560 |
|
|
5,059,344 |
|
|
4,351,365 |
|
LOSS FROM OPERATIONS |
|
|
(2,389,128 |
) |
|
(2,584,359 |
) |
|
(5,031,099 |
) |
|
(4,265,332 |
) |
|
|
|
|
|
|
|
Government grants |
|
|
351,111 |
|
|
79,602 |
|
|
405,352 |
|
|
543,929 |
|
Other income |
|
|
260,283 |
|
|
223 |
|
|
335,841 |
|
|
410 |
|
Loss on disposal |
|
|
(3,149 |
) |
|
- |
|
|
(188,841 |
) |
|
- |
|
Finance expense |
|
|
(117,659 |
) |
|
(11,218 |
) |
|
(225,564 |
) |
|
(11,667 |
) |
Foreign exchange (loss) / gain |
|
|
(3,402 |
) |
|
(36,772 |
) |
|
(500 |
) |
|
938 |
|
|
|
|
487,184 |
|
|
31,835 |
|
|
326,288 |
|
|
533,610 |
|
|
|
|
|
|
|
|
NET LOSS FOR THE PERIOD BEFORE
TAX |
|
|
(1,901,944 |
) |
|
(2,552,524 |
) |
|
(4,704,811 |
) |
|
(3,731,722 |
) |
|
|
|
|
|
|
|
Tax expense |
|
|
3,794 |
|
|
29,538 |
|
|
34,173 |
|
|
29,538 |
|
|
|
|
|
|
|
|
NET LOSS FOR THE PERIOD |
|
|
(1,905,738 |
) |
|
(2,582,062 |
) |
|
(4,738,984 |
) |
|
(3,761,260 |
) |
|
|
|
|
|
|
|
OTHER COMPREHENSIVE (LOSS)
INCOME |
|
|
|
|
|
|
Foreign currency translation adjustment |
|
|
(618,616 |
) |
|
66,393 |
|
|
935,029 |
|
|
29,957 |
|
|
|
|
|
|
|
|
COMPREHENSIVE LOSS FOR THE
PERIOD |
|
$ |
(2,524,354 |
) |
$ |
(2,515,669 |
) |
$ |
(3,803,955 |
) |
$ |
(3,731,303 |
) |
|
|
|
|
|
|
|
Loss per share – Basic and
Diluted |
|
$ |
(0.01 |
) |
$ |
(0.03 |
) |
$ |
(0.03 |
) |
$ |
(0.04 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of shares outstanding –
basic and diluted |
|
$ |
188,640,774 |
|
|
97,438,816 |
|
|
188,640,774 |
|
|
96,014,445 |
|
|
|
|
|
|
|
NOVOHEART HOLDINGS
INC.
Condensed Consolidated Interim Statements of
Cash Flows (unaudited)(Expressed in Canadian dollars)
|
|
|
For the six months ended |
|
|
June 30, 2020 |
|
|
June 30, 2019 |
|
|
|
|
|
CASH FLOWS
FROM OPERATING ACTIVITIES |
|
|
|
Net loss for the period after taxes |
|
$ |
(4,738,984 |
) |
$ |
(3,761,260 |
) |
Items not affecting cash: |
|
|
|
Share-based compensation |
|
|
349,519 |
|
|
448,351 |
|
Lease liabilities interests |
|
|
225,564 |
|
|
- |
|
Amortization of right-of-use assets |
|
|
804,591 |
|
|
- |
|
Depreciation and amortization |
|
|
179,650 |
|
|
338,404 |
|
Loss on disposal |
|
|
188,841 |
|
|
- |
|
Reduction on lease liabilities due to rent concessions |
|
|
(214,113 |
) |
|
- |
|
|
|
|
(3,204,932 |
) |
|
(2,974,505 |
) |
Changes in non-cash working capital items: |
|
|
|
Decrease in accounts and other receivables |
|
|
252,814 |
|
|
357,126 |
|
Decrease / (increase) in prepaid expenses and deposits |
|
|
182,733 |
|
|
(184,845 |
) |
(Decrease) / increase in accounts payable and accrued
liabilities |
|
|
(120,878 |
) |
|
411,158 |
|
Decrease in due to related parties |
|
|
(34,614 |
) |
|
(2,231 |
) |
Decrease in other long-term liabilities |
|
|
(25,560 |
) |
|
(39,256 |
) |
Increase / (decrease) in deferred government grants |
|
|
49,595 |
|
|
(11,398 |
) |
Increase in contract liabilities |
|
|
7,917 |
|
|
475,590 |
|
|
|
|
312,007 |
|
|
1,006,144 |
|
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(2,892,925 |
) |
|
(1,968,361 |
) |
|
|
|
|
CASH FLOWS
FROM INVESTING ACTIVITIES |
|
|
|
Acquisition of equipment |
|
|
(454,376 |
) |
|
(47,270 |
) |
Acquisition of construction in progress |
|
|
(775,240 |
) |
|
- |
|
Cash acquired from acquisition of subsidiary |
|
|
- |
|
|
22,692,695 |
|
Decrease / (increase) in pledged bank deposit |
|
|
5,004,000 |
|
|
(5,028,000 |
) |
|
|
|
|
Net cash generated from investing activities |
|
|
3,774,384 |
|
|
17,617,425 |
|
|
|
|
|
CASH FLOWS
FROM FINANCING ACTIVITIES |
|
|
|
Proceeds from loans |
|
|
- |
|
|
1,688,417 |
|
Payment of lease liabilities and interests |
|
|
(718,100 |
) |
|
- |
|
|
|
|
|
Net cash (used in) / generated from financing activities |
|
|
(718,100 |
) |
|
1,688,417 |
|
|
|
|
|
Changes in
cash and cash equivalents during the period |
|
|
163,359 |
|
|
17,337,481 |
|
|
|
|
|
Effect of exchange rate
changes on cash held in a foreign currency |
|
|
905,585 |
|
|
141,742 |
|
Cash
and cash equivalents, beginning of period |
|
|
12,167,583 |
|
|
666,494 |
|
|
|
|
|
Cash and cash equivalents, end of
period |
|
|
13,236,527 |
|
|
18,145,717 |
|
|
|
|
|
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