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
September 30, 2020.
“We made tremendous strides during the first few
months of Fiscal Year 2021 in executing our strategy to transform
iBio from a modestly performing contract manufacturer into a
dynamic, diversified, innovative biotechnology company,” said Tom
Isett, Chairman & CEO of iBio.
Fiscal
First Quarter
and Recent Business
Developments:
Research & Bioprocessing Products
(“RBP”)
- In October 2020, iBio entered into
an agreement with Safi Biosolutions, Inc. (“Safi”) to evaluate
iBio’s FastPharming® System for
the expression of key proteins to be used in the bioprocessing of
Safi blood cell therapy products.
- To-date, iBio has already
demonstrated the ability to express more than a dozen recombinant
proteins related to the project. The Company plans to commercialize
cytokines and growth factors not designated as “customs” for the
Safi bioprocess and offer them as part of iBio’s new catalog of
proteins for research and further manufacturing uses.
Vaccines
- In August 2020, the Company
announced that IBIO-201 demonstrated an ability to elicit an
anti-SARS-CoV-2 immune response in preclinical studies.
- In September 2020, iBio selected
IBIO-201 as its leading candidate for the prevention of SARS-CoV-2
infection.
- The Company continues preclinical
development of its Virus Like Particle (VLP) platform as well as
IBIO-400, a subunit vaccine for classical swine fever.
Additionally, iBio has selected a Contract Research Organization to
support toxicology studies for IBIO-201, and initiated discussions
with the U.S. Food and Drug Administration regarding the Company’s
COVID-19 vaccine programs.
Therapeutics
- In August 2020,
iBio entered into an exclusive worldwide license agreement with
Planet Biotechnology Inc., for the development of a COVID-19
therapeutic candidate based on an ACE2-Fc immunoadhesin.
Contract Development and Manufacturing (“CDMO”)
Services
- Increased revenues approximately
280% over Q1 FY2020.
“We demonstrated our biopharmaceutical candidate
development capabilities by creating, in-licensing, or advancing
two vaccines and two therapeutics,” commented Mr. Isett.
“Meanwhile, the Safi partnership represents both a new
FastPharming Services customer, as well as a
pathway for iBio to develop our own portfolio of recombinant
protein products for RBP uses. And, despite focusing primarily on
our new biopharmaceutical candidates for fibrotic and infectious
diseases, we successfully increased our CDMO Services revenues in
the period, while diversifying and growing our customer base.”
Fiscal First
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.
- Fiscal year to-date, iBio increased
staffing by approximately 21% to 57 employees, including the new
position of Head of Animal Health Programs.
“Finally, we increased our bench strength and
enhanced our leadership team, adding Randy J. Maddux as Chief
Operating Officer, and welcoming three highly accomplished
Directors to our Board. Their combined experience and expertise
should be invaluable as we execute the next phase of our growth
strategy,” said Mr. Isett.
Financial Results:
For the fiscal quarter ended September 30, 2020,
iBio reported revenues of approximately $0.4 million, an increase
of $0.3 million from approximately $0.1 million in the fiscal
quarter ended September 30, 2019. The increase is attributable to
revenue generated from two new customers. As of September 30, 2020,
revenue backlog was approximately $2.4 million.
Total operating expenses, consisting primarily
of research and development (“R&D”) and general and
administrative (“G&A”) expenses, for the fiscal quarter ended
September 30, 2020 were approximately $7.3 million, compared with
approximately $4.0 million in the same period of 2019.
R&D expenses for the for the fiscal quarter
ended September 30, 2020 were approximately $1.8 million, compared
with approximately $1.0 million in the same period of 2019. The
increase in R&D expense of approximately $0.8 million was
primarily related to an increase in laboratory supplies of
approximately $0.7 million and an increase in R&D personnel
costs of approximately $0.1 million.
G&A expenses for the fiscal quarter ended
September 30, 2020 were approximately $5.5 million, compared with
approximately $3.0 million in the same period of 2019. The increase
resulted primarily from higher professional and consulting fees and
facility repairs and maintenance.
Other expense for the fiscal quarter ended
September 30, 2020 was approximately $0.6 million, consistent with
the same period of 2019.
Net loss attributable to iBio stockholders for
the fiscal quarter ended September 30, 2020 was approximately $7.5
million, or $0.05 per share, compared with a net loss of
approximately $4.5 million, or $0.21 per share, in the same period
of 2019.
As of September 30, 2020, iBio had cash and
investments in securities of approximately $83.5 million, compared
with approximately $55.1 million as of June 30, 2020.
Webcast and Conference Call
iBio management will host a webcast and
conference call at 4:30 p.m. Eastern Time today, November 16, 2020,
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 entering conference code: 2546666.
About iBio, Inc.
iBio is a global leader in plant-based biologics
manufacturing. Its FastPharming® System combines
vertical farming, automated hydroponics, and glycan engineering
technologies to rapidly deliver high-quality monoclonal antibodies,
vaccines, bioinks and other proteins. The Company’s subsidiary,
iBio CDMO LLC, provides FastPharming Contract
Development and Manufacturing Services. iBio’s
Glycaneering Development Service™ includes an
array of new glycosylation technologies for engineering
high-performance recombinant proteins. Additionally, iBio is
developing proprietary products, which include IBIO-100 for the
treatment of fibrotic diseases, and vaccines for infectious
diseases. 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 commercializing
cytokines and growth factors not designated as “customs” for the
Safi bioprocess by offering them as part of the Company’s new
catalog of proteins for research and further manufacturing uses,
developing its own portfolio of recombinant protein products for
RBP uses, the contributions to be made by the newly appointed Chief
Operating Officer and directors and executing on the next phase of
our growth strategy. 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 commercialize
cytokines and growth factors not designated as “customs” for the
Safi bioprocess, the Company’s ability to develop its own portfolio
of recombinant protein products for RBP uses, the Company’s ability
to leverage the experience and expertise of the newly appointed
Chief Operating Officer and directors, the Company’s ability to
execute on its growth strategy, 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 Subsidiaries |
Condensed Consolidated Balance Sheets |
(In Thousands, except share and per share amounts) |
|
|
|
September 30, |
|
|
|
June 30, |
|
|
|
2020 |
|
|
|
2020 |
|
|
|
(Unaudited) |
|
|
|
(See Note 2) |
|
Assets |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
77,543 |
|
|
$ |
55,112 |
|
Accounts receivable - trade |
|
300 |
|
|
|
75 |
|
Subscription receivable |
|
- |
|
|
|
5,549 |
|
Investments in securities |
|
6,010 |
|
|
|
- |
|
Work in process |
|
843 |
|
|
|
798 |
|
Prepaid expenses and other current assets |
|
263 |
|
|
|
214 |
|
Total Current Assets |
|
84,959 |
|
|
|
61,748 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Finance lease right-of-use
assets, net of accumulated amortization |
|
27,201 |
|
|
|
27,616 |
|
Fixed assets, net of
accumulated depreciation |
|
3,834 |
|
|
|
3,657 |
|
Intangible assets, net of
accumulated amortization |
|
1,236 |
|
|
|
1,144 |
|
Security deposit |
|
24 |
|
|
|
24 |
|
Total Assets |
$ |
117,254 |
|
|
$ |
94,189 |
|
|
|
|
|
|
|
|
|
Liabilities and Equity |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable (related parties of $124 and $6 as of September
30, 2020 and June 30, 2020, respectively) |
$ |
1,602 |
|
|
$ |
1,759 |
|
Accrued expenses (related party of $847 and $705 as of September
30, 2020 and June 30, 2020, respectively) |
|
1,406 |
|
|
|
1,105 |
|
Note payable – PPP Loan – current portion |
|
362 |
|
|
|
261 |
|
Finance lease obligation – current portion |
|
306 |
|
|
|
301 |
|
Contract liabilities |
|
1,370 |
|
|
|
1,810 |
|
Total Current Liabilities |
|
5,046 |
|
|
|
5,236 |
|
|
|
|
|
|
|
|
|
Note payable – PPP Loan – net
of current portion |
|
238 |
|
|
|
339 |
|
Finance lease obligation – net
of current portion |
|
31,928 |
|
|
|
32,007 |
|
Total Liabilities |
|
37,212 |
|
|
|
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 September 30, 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
September 30, 2020 and June 30, 2020 |
|
- |
|
|
|
- |
|
Common stock - $0.001 par value; 275,000,000 shares authorized;
180,317,751 and 140,071,110 shares issued and outstanding as of
September 30, 2020 and June 30, 2020, respectively |
|
180 |
|
|
|
140 |
|
Additional paid-in capital |
|
237,867 |
|
|
|
206,931 |
|
Accumulated other comprehensive loss |
|
(40 |
) |
|
|
(33 |
) |
Accumulated deficit |
|
(157,953 |
) |
|
|
(150,420 |
) |
Total iBio, Inc. Stockholders’ Equity |
|
80,054 |
|
|
|
56,618 |
|
Noncontrolling interest |
|
(12 |
) |
|
|
(11 |
) |
Total Equity |
|
80,042 |
|
|
|
56,607 |
|
Total Liabilities and Equity |
$ |
117,254 |
|
|
$ |
94,189 |
|
|
iBio, Inc. and Subsidiaries |
Condensed Consolidated Statements of Operations and
Comprehensive Loss |
(Unaudited; in Thousands, except per share amounts) |
|
|
|
|
Three Months Ended |
|
|
September 30, |
|
|
2020 |
|
|
2019 |
|
Revenues |
$ |
410 |
|
|
$ |
108 |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development (related party of $0 and $97) |
|
1,762 |
|
|
|
977 |
|
General and administrative (related parties of $393 and $321) |
|
5,572 |
|
|
|
2,986 |
|
Total operating expenses |
|
7,334 |
|
|
|
3,963 |
|
|
|
|
|
|
|
|
|
Operating loss |
|
(6,924 |
) |
|
|
(3,855 |
) |
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
Interest expense – related party |
|
(614 |
) |
|
|
(620 |
) |
Interest income |
|
4 |
|
|
|
4 |
|
Royalty income |
|
- |
|
|
|
7 |
|
|
|
|
|
|
|
|
|
Total other income (expense) |
|
(610 |
) |
|
|
(609 |
) |
|
|
|
|
|
|
|
|
Consolidated net loss |
|
(7,534 |
) |
|
|
(4,464 |
) |
Net loss attributable to noncontrolling interest |
|
1 |
|
|
|
1 |
|
Net loss attributable to iBio,
Inc. |
|
(7,533 |
) |
|
|
(4,463 |
) |
Preferred stock dividends |
|
(66 |
) |
|
|
(66 |
) |
Net loss available to iBio,
Inc. |
$ |
(7,599 |
) |
|
$ |
(4,529 |
) |
|
|
|
|
|
|
|
|
Comprehensive loss: |
|
|
|
|
|
|
|
Consolidated net loss |
$ |
(7,534 |
) |
|
$ |
(4,464 |
) |
Other comprehensive loss – unrealized loss on securities |
|
(7 |
) |
|
|
- |
|
Other comprehensive loss - foreign currency translation
adjustments |
|
- |
|
|
|
(1 |
) |
|
|
|
|
|
|
|
|
Comprehensive loss |
$ |
(7,541 |
) |
|
$ |
(4,465 |
) |
|
|
|
|
|
|
|
|
Loss per common share
attributable to iBio, Inc. stockholders – basic and diluted |
$ |
(0.05 |
) |
|
$ |
(0.21 |
) |
|
|
|
|
|
|
|
|
Weighted-average common shares
outstanding – basic and diluted |
|
162,442 |
|
|
|
21,923 |
|
|
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