iBio, Inc. (NYSEA:IBIO) (“iBio” or the “Company”), a developer of
next-generation biopharmaceuticals and pioneer of the sustainable
FastPharming® Manufacturing System, today
announces preliminary unaudited financial results for the fiscal
year ended June 30, 2022, and provides a corporate update.
“We have continued to take important steps
toward achieving our strategic objective of becoming a leading
biotechnology company with a focus on developing innovative
immunotherapies,” said Tom Isett, Chairman & CEO of iBio.
“Chief among these was the RubrYc asset acquisition, which provides
us with a differentiated, AI-powered drug discovery platform and
four promising new candidates to go along with our lead asset,
IBIO-101, an IL-2 sparing anti-CD25 antibody. With an expanded
portfolio and increasing technical, regulatory, and market
challenges for COVID-19 vaccine development, we have decided not to
proceed with an IND submission for IBIO-202, our multi-variant
COVID-19 vaccine candidate. We also continue to review options to
extend our cash runway.”
Recent Business
Developments:
BIOPHARMACEUTICALS
Therapeutics
- Last week, iBio acquired
substantially all the assets of its partner, RubrYc Therapeutics,
Inc. (“RubrYc”). The transaction included RubrYc's artificial
intelligence (“AI”)-driven Discovery Engine; its proprietary
humanized antibody library; all rights, with no future milestone
payment or royalty obligations, to the two immuno-oncology assets
previously licensed in the partnership; and four new immunotherapy
candidates.
- The AI Discovery Engine is unique as it is the only proprietary
machine-learning platform of its kind to combine computational
biology and 3D-modeling of epitopes for the identification and
engineering of large-molecule drug candidates based upon
subdominant, as well as conformational, epitopes that have proven
hard to target using traditional ‘trial-and-error’ screening
methods.
- As part of the RubrYc transaction, the Company now wholly-owns,
with no further financial commitments, its lead immune-oncology
asset, IBIO-101; an IL-2 sparing anti-CD25 antibody aimed at
depleting immunosuppressive regulatory T cells without interfering
with T effector cell anti-tumor effects. As iBio evaluates its
recently increased options for the molecule’s development, the
Company now expects to file an Investigational New Drug (“IND”)
application for IBIO-101 with the U.S. Food and Drug Administration
(“FDA”) in the first half of calendar 2024.
Vaccines
- As previously
reported, preclinical studies of IBIO-202, the Company’s vaccine
candidate that uses a nucleocapsid (“N”) antigen rather than the
more mutable spike (“S”) protein of SARS-CoV-2, demonstrated a
robust, antigen-specific, memory T-cell response. Nevertheless,
data derived from recent IND-enabling challenge studies in
immunologically naïve hamsters showed that IBIO-202 did not provide
protective effect as an “N-only” vaccine. Accordingly, iBio has
decided not to move forward with the IND submission for IBIO-202 in
2023.
- A recent
preclinical study published in the peer-reviewed journal, Science
Translational Medicine, similarly demonstrated that N-only
vaccination provided modest protection from SARS-CoV-2. However,
the study also showed that combining N with S (“N+S”) induced more
robust protection against both Delta and Omicron variants than
S-only vaccination.
- In light of the
challenge study data, the continuing need for a ‘last dose’, not a
‘next dose’ of a COVID-19 vaccine, and iBio’s prospects to secure
non-dilutive funding and/or partnership opportunities for the
program, iBio is evaluating next steps for its proprietary
N-antigen drug substance.
Recent Corporate
Developments:
- At the Company’s Special Meeting of
Stockholders held on June 30, 2022, iBio’s stockholders approved a
proposal giving the Board of Directors (the “Board”) the option to
effect a one for twenty-five (1-for-25) reverse stock split of the
Company’s shares of common stock in the event that it deemed it
advisable.
- iBio announced today the Board has
approved a one for twenty-five (1-for-25) reverse stock split that
will become effective Friday, October 7, 2022, upon the filing of a
Certificate of Amendment to the Company’s Certificate of
Incorporation, as amended, with the Secretary of the State of
Delaware. On Monday, October 10, 2022, the Company’s common stock
will begin trading on a post-reverse split basis on the NYSE
American under the same symbol “IBIO,” but with a new CUSIP number
of 451033609.
“The importance of having flexibility to pursue
our strategic objectives with the availability of additional
issuable shares was underscored with the RubrYc transaction,
financed upfront with iBio common stock,” said Mr. Isett. “We are
pleased that our shareholders voted in favor of the reverse stock
split proposal that could provide the Company with strategic
business management flexibility.”
Preliminary Unaudited Financial
Results:
Revenues for the fiscal year ended June 30,
2022, were approximately $2.4 million, an increase of 1% over
fiscal 2021.
R&D and G&A expenses for fiscal 2022
increased $7.7 million and $12.1 million, respectively, over the
comparable period in fiscal 2021. The growth in R&D and G&A
reflects the Company’s growing investments in its pipeline,
platform technologies, employees, and related infrastructure.
iBio's consolidated net loss for the fiscal year
ended June 30, 2022, was $50.3 million, an increased loss of $27.1
million compared to 2021 due to increased R&D and
administrative expenses incurred to support the Company’s business
strategy and $10.2 million in Fraunhofer USA settlement income in
fiscal 2021 that did not recur in fiscal 2022 offset by $1.8
million in Fraunhofer USA license revenue in fiscal 2022.
iBio held cash, cash equivalents and investments
in debt securities of $39.5 million as of June 30, 2022.
The Company has concluded there is substantial
doubt about the Company's ability to continue as a going concern.
Accordingly, the Company has been informed by its registered public
accounting firm that its audit opinion that will be included in the
Company’s Annual Report on Form 10-K for the fiscal year ended June
30, 2022 to be filed with the Securities and Exchange Commission
will include an explanatory paragraph related to the Company’s
ability to continue as a going concern. This announcement is made
pursuant to NYSE American LLC Company Guide Section 610(b), which
requires public announcement of the receipt of an audit opinion
containing a going concern paragraph. iBio is evaluating a number
of potential options to expand its cash runway, the implementation
of which will impact its liquidity. Potential options being
considered to increase liquidity include lowering our expenses
through decreasing spending, such as with the IBIO-202 program, and
focusing product development on a select number of product
candidates. Additional options include the sale or out-licensing of
certain product candidates or parts of the business, raising money
from capital markets, grant revenue or collaborations, or a
combination thereof.
Webcast and Conference Call
iBio management will host a webcast and
conference call at 4:30 p.m. Eastern Time today, September 27,
2022, to discuss these results and provide additional updates.
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. To access the live call by phone,
participants should go to this registration link,
where they will be provided with the dial-in details.
About iBio, Inc.
iBio develops next-generation biopharmaceuticals
using computational biology and 3D-modeling of hard-to-target
subdominant epitopes along with its sustainable, plant-based
protein expression capabilities for cGMP manufacturing. Its
FastPharming® Manufacturing 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 biopharmaceuticals for the treatment of cancers, as
well as fibrotic and autoimmune diseases. The Company’s
wholly-owned subsidiary, iBio CDMO LLC, provides
FastPharming Contract Development and
Manufacturing Services along with GlycaneeringSM
Development Services for advanced recombinant protein design. For
more information, visit www.ibioinc.com.
FORWARD-LOOKING STATEMENTS
Certain 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 our strategic
objective of becoming a leading biotechnology company with a focus
on developing innovative immunotherapies; reviewing options to
extend the Company’s cash runway; and filing an IND application for
IBIO-101 with the FDA in the first half of calendar 2024. 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
continue to execute its growth strategy; its ability to become a
leading biotechnology company with a focus on developing innovative
immunotherapies its ability to develop additional options to extend
our cash runway; its ability to execute or be successful with any
additional options to extend the Company’s cash runway; its ability
to accelerate the Company’s transformation; its ability to raise
additional capital in order to achieve the Company’s strategic
objectives; its ability to successfully integrate the RubrYc
business with our current management and structure; its ability to
file an IND for IBIO-101 before the first half of 2024; its ability
secure non-dilutive funding and/or partnerships for IBIO-202; its
ability to pursue strategic objectives with the availability of
additional issuable shares; its ability to obtain regulatory
approvals for commercialization of its product candidates, or to
comply with ongoing regulatory requirements; regulatory limitations
relating to its ability to promote or commercialize its product
candidates for specific indications; acceptance of its product
candidates in the marketplace and the successful development,
marketing or sale of products; its ability to maintain its license
agreements; the continued maintenance and growth of its patent
estate; its ability to establish and maintain collaborations and
attract and increase partnership opportunities for its bioprocess
business; successful compliance with governmental regulations
applicable to its manufacturing facility; competition; its ability
to raise additional capital in order to fully execute the Company’s
longer-term business plan and the other factors discussed in the
Company’s filings with the SEC including the Company’s Annual
Report on Form 10-K for the year ended June 30, 2021 and the
Company’s subsequent filings with the SEC on Forms 10-Q and 8-K.
The information in this release is provided only as of the date of
this release, and the Company undertakes 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.
Contact:
Stephen KilmeriBio, Inc.Investor Relations(646)
274-3580skilmer@ibioinc.com
iBio (AMEX:IBIO)
Historical Stock Chart
From Mar 2024 to Apr 2024
iBio (AMEX:IBIO)
Historical Stock Chart
From Apr 2023 to Apr 2024