iBio, Inc. (NYSEA:IBIO) (“iBio” or the “Company”), a biotech
innovator and biologics contract manufacturing organization, today
announced its financial results for the fiscal quarter ended
December 31, 2020.
“We successfully executed against our strategic
priorities during the quarter as we continued to transform the
Company by advancing our pipeline, diversifying our customer base,
and growing our revenues,” said Tom Isett, Chairman & CEO of
iBio.
Fiscal Second Quarter and Recent
Business Developments:
Research & Bioprocess (“RBP”) Products
- The October 2020 agreement with
Safi Biosolutions, Inc. (“Safi”) continues to progress as both
companies work towards generating cytokines and growth factors for
cell therapy manufacturing using iBio’s
FastPharming® System.
- The Company continues to make plans
to commercialize certain cytokines and growth factors as part of a
new catalog of products for research and further manufacturing
uses.
Vaccines
- The ‘end-of-life phase’ of
IND-enabling toxicology studies with IBIO-201, the Company’s
leading candidate for the prevention of SARS-CoV-2 infection, has
been completed. Data analysis is being expedited by iBio’s Contract
Research Organization, and the Company currently expects to receive
a report on the pathology results in early Q4 FY2021.
- iBio is preparing an “Outline of
Production” and facility documentation for submission to the U.S.
Department of Agriculture as the initial step in the regulatory
process towards gaining a U.S. Veterinary Biologics Establishment
License for its Bryan, Texas, FastPharming
Facility. The Company aims to seek this approval for production of
its lead animal health product candidate, IBIO-400, and
prospectively, other biopharmaceuticals for the animal health
markets.
Therapeutics
- In November 2020, the Company
announced that the United States Patent and Trademark Office issued
U.S. Patent No. 10,844,392, entitled “Materials and Methods for
Producing Endostatin Fusion Polypeptides in Plant Cells,” the
claims in which are foundational to iBio’s work on its antifibrotic
therapies.
Contract Development and Manufacturing (“CDMO”)
Services
- In December 2020, iBio announced
that it entered into an agreement with ATB Therapeutics
("atbtherapeutics") to produce its bioengineered antibody-toxin
fusion proteins using iBio's FastPharming
System.
“We are encouraged by the progress we continue
to make in all major segments of our business,” commented Mr.
Isett. “In addition to advancing our vaccine programs and securing
additional IP protection for our antifibrotic therapies, we
expanded our client base for CDMO Services and rapidly advanced our
work on new RBP products.”
Fiscal Second Quarter and Recent
Corporate Developments:
- In October 2020,
iBio appointed Dr. Linda Armstrong, Dr. Alexandra Kropotova and
Gary Sender to its Board of Directors.
- In November
2020, the Company appointed Randy J. Maddux as its Chief Operating
Officer, effective December 1, 2020.
- In December
2020, the Company completed an underwritten public offering of
approximately 29.7 million shares of its common stock for gross
proceeds of $35.0 million.
- In December
2020, iBio appointed Martin B. Brenner, DVM, Ph.D., as its Chief
Scientific Officer, effective January 18, 2021.
- Fiscal year
to-date, iBio increased staffing by approximately 11% to 53
employees, including the new positions of Head of Animal Health
Programs (Melissa Berquist, Ph.D.) and Chief Human Resources
Officer (Lisa Middlebrook).
- Today, the
Company further strengthened its leadership team with the
addition of Mr. Robert M. Lutz as its Chief Financial &
Business Officer, effective March 4, 2021.
“In just a few short months, we
have made eight new key appointments,
who – by virtue of their
deep industry subject matter expertise and track records
of success – demonstrate our commitment to building a
world-class organization,” said Mr. Isett. “Combined
with our increased financial strength and the power
of our platform technologies, we believe that
we are now well positioned to accelerate the development
of our biotherapeutic and vaccine
candidates, in-license promising biopharmaceutical
assets, and leverage the FastPharming System
to its full potential.”
Financial Results:
For the fiscal quarter ended December 31, 2020,
iBio reported revenues of approximately $0.7 million, an increase
of $0.4 million from approximately $0.3 million in the fiscal
quarter ended December 31, 2019.
Total operating expenses, consisting primarily
of research and development (“R&D”) and general and
administrative (“G&A”) expenses, for the fiscal quarter ended
December 31, 2020 were approximately $8.3 million, compared with
approximately $3.5 million in the same period of 2019.
R&D expenses for the for the fiscal quarter
ended December 31, 2020 were approximately $2.4 million, compared
with approximately $0.9 million in the same period of 2019. The
increase in R&D expense of approximately $1.6 million was
primarily related to an increase in laboratory consumables,
supplies and other costs of approximately $1.4 million, and an
increase in R&D personnel costs of approximately $0.2 million
at iBio CDMO, partially offset by an approximately $0.1 million
reduction of other R&D costs. G&A
expenses for the fiscal quarter ended December 31, 2020 were
approximately $5.8 million, compared with approximately $2.6
million in the same period of 2019. The increase resulted primarily
from higher professional and consulting fees of approximately $1.4
million, facility repairs and maintenance of approximately $0.6
million, personnel costs of approximately $0.4 million, public
company costs of $0.3 million, insurance of approximately $0.3
million and board of director fees of approximately $0.1
million.
Other expense for the fiscal quarter ended
December 31, 2020 was approximately $0.6 million, consistent with
the same period of 2019.
Net loss attributable to iBio stockholders for
the fiscal quarter ended December 31, 2020 was approximately $8.2
million, or $0.04 per share. This compared with a net loss of
approximately $25.4 million, or $0.69 per share, in the same period
of 2019, which included deemed dividends due to the down round
feature of Series A Preferred Stock and Series B Preferred Stock of
approximately $21.6 million.
As of December 31, 2020, iBio had cash and cash
equivalents plus investments in debt securities of approximately
$107.6 million.
Webcast and Conference Call
iBio management will host a webcast and
conference call at 4:30 p.m. Eastern Time today, February 16, 2021,
to discuss these results and provide a corporate update.
The live and archived webcast may be accessed on
the Company’s website at www.ibioinc.com under “News and
Events” in the Investors section. The live call can be accessed by
dialing (833) 672-0651 (domestic) or (929) 517-0227 (international)
and referencing conference code: 7891625.
About iBio, Inc.
iBio is a global leader in plant-based biologics
manufacturing. Its FastPharming® System combines
vertical farming, automated hydroponics, and novel glycosylation
technologies to rapidly deliver high-quality monoclonal antibodies,
vaccines, bioinks and other proteins. iBio is developing
proprietary products on the FastPharming Platform,
which include biopharmaceuticals for the treatment of fibrotic and
infectious diseases, amongst others. The Company’s subsidiary, iBio
CDMO LLC, provides FastPharming Contract
Development and Manufacturing Services, including
Glycaneering™ Development Services for advanced
recombinant protein design. For more information, visit
www.ibioinc.com.
FORWARD-LOOKING
STATEMENTSCertain statements in this press release
constitute "forward-looking statements" within the meaning of the
federal securities laws. Words such as "may," "might," "will,"
"should," "believe," "expect," "anticipate," "estimate,"
"continue," "predict," "forecast," "project," "plan," "intend" or
similar expressions, or statements regarding intent, belief, or
current expectations, are forward-looking statements. These
forward-looking statements are based upon current estimates and
assumptions and include statements regarding progress towards
generating cytokines and growth factors for cell therapy
manufacturing using iBio’s FastPharming® System,
plans to commercialize certain cytokines and growth factors as part
of a new catalog of products for research and further manufacturing
uses, the receipt of a report on the IBIO-201 pathology results in
early Q4 2021, seeking approval for production of the Company’s
lead animal health product candidate, IBIO-400, and prospectively,
other biopharmaceuticals for the animal health markets. the
contributions to be made by the newly appointed Chief Operating
Officer, Chief Scientific Officer, Chief Financial & Business
Officer and directors and being well positioned to accelerate
development of the Company’s biotherapeutic and vaccine candidates,
in-license promising biopharmaceutical assets and leverage the
FastPharming System to its full potential. While
the Company believes these forward-looking statements are
reasonable, undue reliance should not be placed on any such
forward-looking statements, which are based on information
available to us on the date of this release. These forward-looking
statements are subject to various risks and uncertainties, many of
which are difficult to predict that could cause actual results to
differ materially from current expectations and assumptions from
those set forth or implied by any forward-looking statements.
Important factors that could cause actual results to differ
materially from current expectations include, among others, the
Company’s ability to progress generating cytokines and growth
factors for cell therapy manufacturing using iBio’s
FastPharming System and commercialize cytokines
and growth factors, the ability to generate the IBIO-201 pathology
results as planned, the Company’s ability to leverage the
experience and expertise of the newly appointed Chief Operating
Officer, Chief Scientific Officer, Chief Financial & Business
Officer and directors, the Company’s ability to accelerate
development of its biotherapeutic and vaccine candidates,
in-license promising biopharmaceutical assets and leverage the
FastPharming System to its full potential, the
Company’s ability to obtain regulatory approvals for
commercialization of its product candidates, including its COVID-19
vaccines, or to comply with ongoing regulatory requirements,
regulatory limitations relating to its ability to promote or
commercialize the Company’s product candidates for specific
indications, acceptance of the Company’s product candidates in the
marketplace and the successful development, marketing or sale of
the Company’s products, the Company’s ability to maintain its
license agreements, the continued maintenance and growth of its
intellectual property portfolio, the Company’s ability to establish
and maintain collaborations, the Company’s ability to obtain or
maintain the capital or grants necessary to fund its research and
development activities, competition, the Company’s ability to
retain its key employees or maintain its NYSE American listing, and
the other risk factors discussed in the Company’s most recent
Annual Report on Form 10-K and the Company’s subsequent filings
with the SEC, including subsequent periodic reports on Forms 10-Q
and 8-K. The information in this release is provided only as of the
date of this release, and we undertake no obligation to update any
forward-looking statements contained in this release on account of
new information, future events, or otherwise, except as required by
law.
Contacts:
Stephen KilmeriBio, Inc.Investor Relations(646)
274-3580 skilmer@ibioinc.com
iBio, Inc. and
SubsidiariesCondensed Consolidated Balance
Sheets(In Thousands, except share and per share
amounts)
|
|
December 31,2020 |
|
|
June 30,2020 |
|
|
|
(Unaudited) |
|
|
(Unaudited) |
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
91,252 |
|
|
$ |
55,112 |
|
Accounts receivable – trade |
|
|
180 |
|
|
|
75 |
|
Accounts receivable – other |
|
|
52 |
|
|
|
- |
|
Subscription receivable |
|
|
- |
|
|
|
5,549 |
|
Investments in debt securities |
|
|
16,395 |
|
|
|
- |
|
Work in process |
|
|
1,071 |
|
|
|
798 |
|
Prepaid expenses and other current assets |
|
|
1,932 |
|
|
|
214 |
|
Total Current Assets |
|
|
110,882 |
|
|
|
61,748 |
|
|
|
|
|
|
|
|
|
|
Convertible promissory note
receivable and accrued interest |
|
|
1,519 |
|
|
|
- |
|
Finance lease right-of-use
assets, net of accumulated amortization |
|
|
26,786 |
|
|
|
27,616 |
|
Fixed assets, net of
accumulated depreciation |
|
|
5,010 |
|
|
|
3,657 |
|
Intangible assets, net of
accumulated amortization |
|
|
1,185 |
|
|
|
1,144 |
|
Security deposit |
|
|
24 |
|
|
|
24 |
|
Total Assets |
|
$ |
145,406 |
|
|
$ |
94,189 |
|
|
|
|
|
|
|
|
|
|
Liabilities and Equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable (related parties of $94 and $6 as of December 31,
2020 and June 30, 2020, respectively) |
|
$ |
2,409 |
|
|
$ |
1,759 |
|
Accrued expenses (related party of $703 and $705 as of December 31,
2020 and June 30, 2020, respectively) |
|
|
1,683 |
|
|
|
1,105 |
|
Finance lease obligation – current portion |
|
|
312 |
|
|
|
301 |
|
Note payable – PPP loan– current portion |
|
|
465 |
|
|
|
261 |
|
Contract liabilities |
|
|
1,233 |
|
|
|
1,810 |
|
Total Current Liabilities |
|
|
6,102 |
|
|
|
5,236 |
|
|
|
|
|
|
|
|
|
|
Note payable – PPP Loan – net
of current portion |
|
|
135 |
|
|
|
339 |
|
Finance lease obligation – net
of current portion |
|
|
31,848 |
|
|
|
32,007 |
|
Total Liabilities |
|
|
38,085 |
|
|
|
37,582 |
|
|
|
|
|
|
|
|
|
|
Commitments and
Contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity |
|
|
|
|
|
|
|
|
iBio, Inc. Stockholders’ Equity: |
|
|
|
|
|
|
|
|
Preferred stock – no par value; 1,000,000 shares authorized; iBio
CMO Preferred Tracking Stock; 1 share authorized, issued and
outstanding as of both December 31, 2020 and June 30, 2020 |
|
|
- |
|
|
|
- |
|
Series B Convertible Preferred Stock - $1,000 stated value; 5,785
shares authorized; 0 and 5,785 shares issued and outstanding as
of December 31, 2020 and June 30, 2020 |
|
|
- |
|
|
|
- |
|
Common stock - $0.001 par value; 275,000,000 and 275,000,000 shares
authorized at December 31, 2020 and June 30, 2020,
respectively; 211,769,103 and 140,071,110 shares issued and
outstanding as of December 31, 2020 and June 30, 2020,
respectively |
|
|
212 |
|
|
|
140 |
|
Additional paid-in capital |
|
|
273,258 |
|
|
|
206,931 |
|
Accumulated other comprehensive loss |
|
|
(53 |
) |
|
|
(33 |
) |
Accumulated deficit |
|
|
(166,082 |
) |
|
|
(150,420 |
) |
Total iBio, Inc. Stockholders’ Equity |
|
|
107,335 |
|
|
|
56,618 |
|
Noncontrolling interest |
|
|
(14 |
) |
|
|
(11 |
) |
Total Equity |
|
|
107,321 |
|
|
|
56,607 |
|
Total Liabilities and Equity |
|
$ |
145,406 |
|
|
$ |
94,189 |
|
iBio, Inc. and
SubsidiariesCondensed Consolidated Statements of
Operations and Comprehensive Loss(Unaudited; in Thousands,
except per share amounts)
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
Revenues |
|
$ |
705 |
|
|
$ |
314 |
|
|
$ |
1,115 |
|
|
$ |
422 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development (related party of $0, $0, $0 and $97) |
|
|
2,444 |
|
|
|
888 |
|
|
|
4,206 |
|
|
|
1,865 |
|
General and administrative (related party of $510, $304, $903 and
$572) |
|
|
5,806 |
|
|
|
2,581 |
|
|
|
11,378 |
|
|
|
5,567 |
|
Total operating expenses |
|
|
8,250 |
|
|
|
3,469 |
|
|
|
15,584 |
|
|
|
7,432 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(7,545 |
) |
|
|
(3,155 |
) |
|
|
(14,469 |
) |
|
|
(7,010 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense (related party of $612, $615, $1,226 and
$1,235) |
|
|
(615 |
) |
|
|
(615 |
) |
|
|
(1,229 |
) |
|
|
(1,235 |
) |
Interest income |
|
|
27 |
|
|
|
4 |
|
|
|
31 |
|
|
|
8 |
|
Royalty income |
|
|
2 |
|
|
|
2 |
|
|
|
2 |
|
|
|
9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income (expense) |
|
|
(586 |
) |
|
|
(609 |
) |
|
|
(1,196 |
) |
|
|
(1,218 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated net loss |
|
|
(8,131 |
) |
|
|
(3,764 |
) |
|
|
(15,665 |
) |
|
|
(8,228 |
) |
Net loss attributable to noncontrolling interest |
|
|
2 |
|
|
|
2 |
|
|
|
3 |
|
|
|
3 |
|
Net loss attributable to iBio,
Inc. |
|
|
(8,129 |
) |
|
|
(3,762 |
) |
|
|
(15,662 |
) |
|
|
(8,225 |
) |
Preferred stock dividends – iBio CMO Tracking Stock |
|
|
(65 |
) |
|
|
(65 |
) |
|
|
(131 |
) |
|
|
(131 |
) |
Deemed dividends – down round of Series A Preferred and Series B
Preferred |
|
|
- |
|
|
|
(21,560 |
) |
|
|
- |
|
|
|
(21,560 |
) |
Net loss available to iBio,
Inc. stockholders |
|
$ |
(8,194 |
) |
|
$ |
(25,387 |
) |
|
$ |
(15,793 |
) |
|
$ |
(29,916 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated net loss |
|
$ |
(8,131 |
) |
|
$ |
(3,764 |
) |
|
$ |
(15,665 |
) |
|
$ |
(8,228 |
) |
Other comprehensive loss – unrealized loss on debt securities |
|
|
(13 |
) |
|
|
- |
|
|
|
(20 |
) |
|
|
- |
|
Other comprehensive loss – foreign currency translation
adjustments |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(1 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(8,144 |
) |
|
$ |
(3,764 |
) |
|
$ |
(15,685 |
) |
|
$ |
(8,229 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per common share attributable to iBio, Inc. stockholders -
basic and diluted |
|
$ |
(0.04 |
) |
|
$ |
(0.69 |
) |
|
$ |
(0.09 |
) |
|
$ |
(1.02 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares
outstanding - basic and diluted |
|
|
188,087 |
|
|
|
36,917 |
|
|
|
175,264 |
|
|
|
29,420 |
|
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