iBio, Inc. (NYSEA:IBIO) (“iBio” or the “Company”), a developer of
next-generation biopharmaceuticals and pioneer of the sustainable
FastPharming Manufacturing System®, today
announces its financial results for the fiscal quarter ended
September 30, 2021 and provides a corporate update.
“We are continuing to accelerate the execution
of our growth strategy as we start our fiscal year 2022,” said Tom
Isett, Chairman & CEO of iBio. “Having only just launched our
oncology initiative six months ago, we have already created six
active programs, including the two new ones announced today. In
addition, we have advanced our novel COVID-19 vaccine candidate to
pre-IND, while concurrently building out our vaccine platform with
new drug delivery technology partnerships. We have also acquired
our cGMP manufacturing facility and taken sole ownership of our
CDMO subsidiary, along with the attendant rights to manufacture
biologics using our FastPharming System in the
United States. We are confident that our investments over the past
year in talent, technology, and infrastructure will return value to
patients and shareholders as we go forward.”
Fiscal First Quarter and Recent Business
Developments:
BIOPHARMACEUTICALS
Therapeutics
- In August 2021,
iBio added to its pipeline by in-licensing an IL-2 sparing
anti-CD25 antibody (IBIO-101) from RubrYc Therapeutics.
Pre-clinical data shows that the molecule can deplete regulatory T
cells from the tumor microenvironment and restore anti-tumor
immunity, potentially representing an important new tool in the
fight against cancer.
- The Company
continues to advance its endostatin E4 molecule for fibrotic
diseases (IBIO-100) toward the clinic. Meanwhile, leveraging its
investment in endostatin E4, iBio announced earlier today that it
will separately explore the molecule’s usefulness in the treatment
of solid tumors as part of a research collaboration with the
University of Texas Southwestern Medical Center.
- Pursuant to its
new partnership with RubrYc Therapeutics wherein artificial
intelligence (“AI”)-based antibody discovery technologies are
deployed, iBio announces today that the first new target is now
being optimized using the platform. This result follows just two
months after the joint discovery collaboration was initiated.
Vaccines
- The Company
recently conducted a preclinical dose ranging study of IBIO-202,
its nucleocapsid (“N”) antigen-based, intramuscularly
(“IM”)-delivered COVID-19 vaccine candidate. The results confirmed
generation of a robust, antigen-specific, memory T-cell response
and provided data that further informed iBio’s product formulation
strategy.
- The Company
submitted a pre-IND package for IBIO-202 to the U.S. Food and Drug
Administration in September 2021 and is anticipating a response in
the coming months.
- Today, iBio
announces that is has entered a collaboration with a leading
innovator of microarray patch systems, which are a painless
alternative to IM injections. The first objective of the
collaboration is to evaluate feasibility of intradermal delivery of
a COVID-19 vaccine antigen. If successful, the partnership has the
potential to drive improved access to vaccines by avoiding cold
chain issues and possibly enabling self-administration. The
collaboration is not expected to impact the current development
timeline of IBIO-202.
- The Company
continues to advance its Classical Swine Fever (“CSF”) vaccine
candidate, IBIO-400, through the U.S. Department of Agriculture’s
Centers for Veterinary Biologics’ regulatory process. Additionally,
iBio announces today that studies are now underway at Texas A&M
University System to evaluate alternatives to IM injection of its
CSF vaccine candidate, including an oral dose option.
BIOPROCESS
- In November
2021, iBio purchased the Bryan, Texas, manufacturing facility it
previously operated under a lease from two affiliates of Eastern
Capital Limited (the “Eastern Affiliates”). The Company also
acquired the equity interest in iBio CDMO, LLC, that was formerly
held by the Eastern Affiliates. As a result, the subsidiary and its
intellectual property are now wholly-owned by iBio.
Fiscal First Quarter and Recent
Corporate Developments:
- iBio made
progress in government relations during the quarter by engaging
with senior-level U.S. policymakers to build awareness of the
FastPharming System and to underscore the benefits
of rapid, sustainable, domestic bioproduction.
- iBio is
encouraging shareholders who held common stock at the close of
business on October 15, 2021 to vote “FOR” all proposals put forth
in the proxy statement prior to its December 9, 2021, Annual
Meeting of Stockholders to help the Company continue to grow its
pipeline, services, and value.
“Over the course of the next year, we are
focused on delivering shareholder value across multiple fronts,
including announcing new oncology targets and two possible IND
filings,” said Mr. Isett. “We are also excited about the
partnership opportunities that we see ahead for our bioprocess
business as industry awareness of the need to implement
sustainable, ESG-based practices continues to grow. With sole
ownership of our FastPharming Facility and CDMO
subsidiary now secured, we have additional strategic and
operational flexibility to deploy our rapid, scalable biologics
development system for our own pipeline, as well as for clients, so
that we may enable more potentially life-saving therapeutics to
enter the clinic.”
Financial Results:
Revenues for the first fiscal quarter ended
September 30, 2021, were approximately $211,000, a decrease of 49%
from approximately $410,000 in the same period of 2020. As noted
previously, significant quarter-to-quarter revenue variability is
commonplace for early-stage pharma services companies given the
timing of revenue recognition. Consistent with these business
dynamics, iBio continues to expect a sequential decline in
revenue during the first half of fiscal
2022 compared to the second half of fiscal 2021, followed
by higher growth in the second half of fiscal 2022.
R&D and G&A expenses for the first
quarter of fiscal 2022 increased 35% and 24%, respectively, over
the comparable period in fiscal 2020. This reflects the Company’s
growing investments in its pipeline, platform technologies,
employees, and related infrastructure. iBio anticipates this trend
continuing, however, the rate of growth is expected to moderate
over time.
iBio's consolidated net loss for the first
quarter ended September 30, 2021, was approximately $8.9 million,
or $0.04 per share, compared to a net loss of approximately $7.5
million, or $0.05 per share, in the same period of 2020.
iBio had $82.3 million dollars in cash and cash
equivalents and investments in debt securities as of September 30,
2021. The Company used $9.3 million in cash during the quarter for
operating activities and $5.1M for investing activities which
included elements of the RubrYc transaction and for capital
expenditures. Subsequent to the end of the first quarter of fiscal
2021, iBio used approximately $6.0 million in cash to help fund the
purchase of its manufacturing facility in Bryan, Texas, and to
secure full control of iBio CDMO, LLC, which holds the exclusive
rights to manufacture using
the FastPharming System in the United
States. Taking into account potential long-term financing options,
combined with the approximate 67% savings in facility-related cash
requirements expected to be achieved through this transaction, the
Company continues to believe that its current cash position is
sufficient to fund its operations through Q3-FY23. If the Company
cannot take advantage of the additional financial flexibility, and
based on the Company’s working capital on September 30, 2021,
management has concluded that there is sufficient liquidity to fund
normal operations through at least Q2-FY23.
Webcast and Conference Call
iBio management will host a webcast and
conference call at 4:30 p.m. Eastern Time today, November 15, 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: 7779281.
About iBio, Inc.
iBio is a developer of next-generation
biopharmaceuticals and a pioneer in sustainable, 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 biopharmaceuticals for the treatment of
cancers, as well as fibrotic and infectious diseases. The Company’s
wholly-owned subsidiary, iBio CDMO LLC, provides
FastPharming Contract Development and
Manufacturing Services along with Glycaneering
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 continuing to
accelerate the execution of iBio’s growth strategy as it starts its
fiscal year 2022, iBio’s investments over the past year in talent,
technology, and infrastructure returning value to patients and
shareholders, continuing to advance iBio’s endostatin E4 molecule
for fibrotic diseases (IBIO-100) towards the clinic, iBio’s
endostatin E4 molecule’s usefulness in the treatment for solid
tumors, the anticipated response in the coming months from the U.S.
Food and Drug Administration to the pre-IND package for IBIO-202,
the collaboration with a leading innovator of microarray patch
systems resulting in the potential to drive improved patient access
to vaccines and possibly enable patient self-administration without
impacting the current development timelines of IBIO-202, the
continued advancement of iBio’s Classical Swine Fever vaccine
candidate, IBIO-400, through the U.S. Department of Agriculture’s
Centers for Veterinary Biologics’ regulatory process, partnership
opportunities for iBio’s bioprocess business as industry awareness
of the need to implement sustainable ESG-based practices continues
to grow, enabling more potentially life-saving therapeutics to
enter the clinic, continuing iBio’s trend of growing investments in
its pipeline, platform technologies, employees, and related
infrastructure trend with a rate of growth being more moderate over
time, , the approximate 67% savings in facility-related cash
requirements expected to be achieved through the purchase of the
manufacturing facility, the current cash position being sufficient
to fund operations through the third quarter of fiscal 2023, taking
into account potential long-term financing options combined with
the anticipated savings in facility-related cash requirements, and
the cash position being sufficient to fund normal operations
through at least Q2 2023 if iBio cannot take advantage of the
additional financial flexibility. 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 successfully
implement its development plans and continue to accelerate the
execution of its growth strategy, including the ability to initiate
IND-enabling studies for iBio’s endostatin E4 molecule for fibrotic
diseases (IBIO-100) as planned and the ability to utilize the
molecule in solid tumors, the ability to advance IBIO-400, through
the regulatory process, 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 iBio’s bioprocess business, its
ability to achieve the savings anticipated with the purchase of the
manufacturing facility and obtain or maintain the capital or grants
necessary to fund its research and development activities and
whether the Company will incur unforeseen expenses or liabilities
or other market factors, successful compliance with governmental
regulations applicable to its manufacturing facility, competition,
its ability to retain its key employees or maintain its NYSE
American listing, its ability to increase its authorized shares,
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, Inc. and
Subsidiaries
Condensed Consolidated Balance
Sheets
(In Thousands, except share and per share
amounts)
|
|
|
|
|
|
|
|
|
September 30, |
|
June 30, |
|
|
2021 |
|
2021 |
|
|
(Unaudited) |
|
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
62,820 |
|
|
$ |
77,404 |
|
Accounts receivable - trade |
|
|
207 |
|
|
|
426 |
|
Settlement receivable - current portion |
|
|
5,100 |
|
|
|
5,100 |
|
Investments in debt securities |
|
|
19,453 |
|
|
|
19,570 |
|
Inventory |
|
|
587 |
|
|
|
27 |
|
Prepaid expenses and other current assets |
|
|
1,650 |
|
|
|
2,070 |
|
Total Current Assets |
|
|
89,817 |
|
|
|
104,597 |
|
|
|
|
|
|
|
|
Convertible promissory note
receivable and accrued interest |
|
|
1,575 |
|
|
|
1,556 |
|
Settlement receivable -
noncurrent portion |
|
|
5,100 |
|
|
|
5,100 |
|
Finance lease right-of-use
assets, net of accumulated amortization |
|
|
25,695 |
|
|
|
26,111 |
|
Operating lease right-of-use
asset |
|
|
3,487 |
|
|
|
— |
|
Fixed assets, net of
accumulated depreciation |
|
|
9,821 |
|
|
|
8,628 |
|
Intangible assets, net of
accumulated amortization |
|
|
5,164 |
|
|
|
952 |
|
Investment in equity security
- at cost |
|
|
1,760 |
|
|
|
— |
|
Prepaid expenses -
noncurrent |
|
|
1,296 |
|
|
|
— |
|
Security deposits |
|
|
24 |
|
|
|
24 |
|
Total Assets |
|
$ |
143,739 |
|
|
$ |
146,968 |
|
|
|
|
|
|
|
|
Liabilities and Equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
2,292 |
|
|
$ |
2,254 |
|
Accrued expenses (related party of $840 and $701 as of
September 30, 2021 and June 30, 2021,
respectively) |
|
|
2,691 |
|
|
|
3,001 |
|
Acquisition Payable |
|
|
2,500 |
|
|
|
— |
|
Finance lease obligations - current portion |
|
|
374 |
|
|
|
367 |
|
Operating lease obligation - current portion |
|
|
147 |
|
|
|
— |
|
Note payable - PPP loan - current portion |
|
|
— |
|
|
|
600 |
|
Contract liabilities |
|
|
94 |
|
|
|
423 |
|
Total Current Liabilities |
|
|
8,098 |
|
|
|
6,645 |
|
|
|
|
|
|
|
|
Finance lease obligations -
net of current portion |
|
|
31,660 |
|
|
|
31,755 |
|
Operating lease obligation -
net of current portion |
|
|
3,456 |
|
|
|
— |
|
|
|
|
|
|
|
|
Total Liabilities |
|
|
43,214 |
|
|
|
38,400 |
|
|
|
|
|
|
|
|
Commitments and
Contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity |
|
|
|
|
|
|
iBio, Inc. Stockholders’ Equity: |
|
|
|
|
|
|
Common stock - $0.001 par value; 275,000,000 shares authorized at
September 30, 2021 and June 30, 2021;
217,957,594 and 217,873,094 shares issued and outstanding as of
September 30, 2021 and June 30, 2021,
respectively |
|
|
217 |
|
|
|
217 |
|
Additional paid-in capital |
|
|
282,956 |
|
|
|
282,058 |
|
Accumulated other comprehensive loss |
|
|
(64 |
) |
|
|
(63 |
) |
Accumulated deficit |
|
|
(182,566 |
) |
|
|
(173,627 |
) |
Total iBio, Inc. Stockholders’ Equity |
|
|
100,543 |
|
|
|
108,585 |
|
Noncontrolling interest |
|
|
(18 |
) |
|
|
(17 |
) |
Total Equity |
|
|
100,525 |
|
|
|
108,568 |
|
Total Liabilities and Equity |
|
$ |
143,739 |
|
|
$ |
146,968 |
|
iBio, Inc. and
Subsidiaries
Condensed Consolidated Statements of
Operations and Comprehensive Loss
(Unaudited; in Thousands, except per share
amounts)
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
September 30, |
|
|
2021 |
|
2020 |
|
|
|
|
|
|
|
Revenues |
|
$ |
211 |
|
|
$ |
410 |
|
|
|
|
|
|
|
|
Cost of goods sold |
|
|
40 |
|
|
|
107 |
|
|
|
|
|
|
|
|
Gross profit |
|
|
171 |
|
|
|
303 |
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
|
2,511 |
|
|
|
1,862 |
|
General and administrative (related party of $189 and $393) |
|
|
6,634 |
|
|
|
5,365 |
|
Total operating expenses |
|
|
9,145 |
|
|
|
7,227 |
|
|
|
|
|
|
|
|
Operating loss |
|
|
(8,974 |
) |
|
|
(6,924 |
) |
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
Interest expense (related party of $608 and $614) |
|
|
(609 |
) |
|
|
(614 |
) |
Interest income |
|
|
36 |
|
|
|
4 |
|
Forgiveness of note payable and accrued interest - SBA loan |
|
|
607 |
|
|
|
— |
|
Total other income (expense) |
|
|
34 |
|
|
|
(610 |
) |
|
|
|
|
|
|
|
Consolidated net loss |
|
|
(8,940 |
) |
|
|
(7,534 |
) |
Net loss attributable to noncontrolling interest |
|
|
1 |
|
|
|
1 |
|
Net loss attributable to iBio,
Inc. |
|
|
(8,939 |
) |
|
|
(7,533 |
) |
|
|
|
|
|
|
|
Preferred stock dividends |
|
|
(66 |
) |
|
|
(66 |
) |
Net loss attributable to iBio,
Inc. stockholders |
|
$ |
(9,005 |
) |
|
$ |
(7,599 |
) |
|
|
|
|
|
|
|
Comprehensive loss: |
|
|
|
|
|
|
Consolidated net loss |
|
$ |
(8,940 |
) |
|
$ |
(7,534 |
) |
Other comprehensive loss - unrealized loss on debt securities |
|
|
(1 |
) |
|
|
(7 |
) |
Other comprehensive loss - foreign currency translation
adjustments |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(8,941 |
) |
|
$ |
(7,541 |
) |
|
|
|
|
|
|
|
Loss per common share
attributable to iBio, Inc. stockholders - basic and diluted |
|
$ |
(0.04 |
) |
|
$ |
(0.05 |
) |
|
|
|
|
|
|
|
Weighted-average common shares
outstanding - basic and diluted |
|
|
217,876 |
|
|
|
162,442 |
|
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