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 March
31, 2022 and provides a corporate update.
“In this quarter, we took multiple steps forward
towards becoming a clinical-stage company – a potentially major
value inflection point,” said Tom Isett, Chairman & CEO of
iBio. “We anticipate there may be a notable medical and business
opportunity for our nucleocapsid-based COVID-19 vaccine candidate,
as the durability and efficacy of the existing spike-based vaccines
are called into question at the same time as new waves of variants
are forecasted to arrive. Concurrently, we are rapidly advancing
our lead immuno-oncology asset, the IL-2-sparing anti-CD25 antibody
IBIO-101, with plans to be in the clinic in calendar 2023. In
addition, our early-stage drug discovery programs are all advancing
well, and we also continue to demonstrate the quality of our
FastPharming System and potency-enhancing
capability of our GlycaneeringSM Technology.
Altogether, we believe that we are well-positioned to continue
executing our growth strategy.”
Third Quarter and Recent Business
Developments:
BIOPHARMACEUTICALS
Vaccines
- Investigational
New Drug (“IND”)-Enabling challenge studies of IBIO-202, the
Company’s second-generation vaccine candidate for multi-variant
COVID-19 disease, are underway and proceeding as planned. Assuming
favorable study outcomes, iBio plans to file an IND application
with the U.S. Food and Drug Administration (“FDA”) before the end
of calendar 2022.
- Separately,
iBio continues to evaluate the feasibility of intradermal delivery
of its vaccine candidates, including its SARS-CoV-2 nucleocapsid
antigen, through its work with a leading innovator of microarray
patch systems.
- Data analysis
from the immunogenicity study of IBIO-400 has confirmed
intramuscular injection is the preferred route of administration
for the Company’s vaccine candidate for Classical Swine Fever.
Updated efficacy protocols, manufacturing processes, and validation
plans were submitted to the U.S. Department of Agriculture (“USDA”)
during the quarter to enable manufacturing clearance of pre-license
lots for studies material to licensure. Given that regulatory
review can be extended for first time applicants, iBio is
estimating a response from the USDA on the submission within
approximately 12 months.
Therapeutics
- iBio continues
to develop its IL-2 sparing anti-CD25 antibody, IBIO-101, on the
FastPharming Platform. Comparability studies have
demonstrated that by applying the Company’s
Glycaneering Technology, the
FastPharming System produces a potent,
high-quality, afucosylated molecule that is equivalent to the same
version of the antibody produced with traditional mammalian cell
culture manufacturing methods.
- The Company
announced today that it has completed the Lead Optimization stage
in the development of IBIO-101 and has entered the IND-Enabling
stage. An IND for IBIO-101 is expected before the end of Q2 of
calendar 2023.
- RubrYc
Therapeutics (“RubrYc”) achieved a technology validation milestone
with a third party during the quarter. As a result, iBio acquired
approximately 1.0 million additional shares of RubrYc for $2.5
million per the existing Stock Purchase Agreement.
- Initial data
from the evaluation of the potential anti-cancer effects of the
Company’s endostatin E4 molecule in combination with other cancer
treatments upon fibrotic tumors is expected in the second half of
calendar year 2022.
BIOPROCESS
- Pursuant to a
second Statement of Work (“SOW”) under an existing Master Joint
Development Agreement between iBio and Safi Biosolutions, Inc.,
iBio will assist Safi in its efforts related to the USU 4D Bio3
On-Demand Blood program, funded by the Defense Health Program
(DHP), by utilizing the FastPharming system to
make one of the most critical reagents used in the production of
Safi’s manufactured Red Blood Cells (mRBCs).
- iBio recognized
$1.8 million in royalty revenue from the license of its plant-based
drug manufacturing intellectual property to Fraunhofer USA, Inc.
(“Fraunhofer USA”). It also received the first of two $5.1 million
payments from Fraunhofer USA related to the settlement of the
intellectual property dispute.
Third Quarter and Recent Corporate
Developments:
- On January 31,
2022, the Company reconvened its 2021 Annual Meeting to allow more
of its stockholders to consider and vote on Proposal 4 (Reverse
Stock Split) and Proposal 5 (Change in Authorized Shares). Although
approximately 65% and 68% of the votes received were in favor of
Proposal 4 and Proposal 5, respectively, the total number of shares
voting in favor were insufficient for them to
pass.
- Today, the
Company filed its preliminary proxy materials with the U.S.
Securities and Exchange Commission (“SEC”) in connection with a
Special Meeting of Stockholders (the “Special Meeting”) to approve
two similar proposals (Reverse Stock Split and Change in Authorized
Shares) (the “Proposals”).
- The Company has
entered into a securities purchase agreement with a certain
accredited investor for the issuance and sale of 1,000 shares of
Series 2022 Convertible Preferred Stock, $0.001 par value per share
(the “Preferred Stock”), at a price of $0.27 per share. The
Preferred Stock permits the holder to vote at the Special Meeting,
on the Reverse Stock Split proposal, with the holders of the common
stock as a single class, with each share of Preferred Stock being
entitled to 5,000,000 votes per share, provided that any votes cast
by the Preferred Stock with respect to the Proposal must be voted
in the same proportion as the aggregate shares of common stock are
voted on the Proposal. At its sole discretion, the Company’s Board
of Directors may convert the Preferred Stock to common stock at a
conversion ratio of 1:1.
“The increasing prevalence of brokerage firms
opting to forego discretionary or proportionate voting of the
shares held by them in street name has made it significantly more
difficult for companies like iBio with a large retail stockholder
base, to secure affirmative votes from a majority of the
outstanding shares entitled to vote,” said Mr. Isett. “Over the
past few weeks, we have been exploring ways to overcome that
structural impediment to implementing the will of our voting
stockholders and believe that the Preferred Stock placement
provides an elegant and validated solution; serving to amplify, but
not fundamentally alter, the underlying vote.”
Financial Results:
Revenues for the third quarter ended March 31,
2022, were approximately $1.9 million, an increase of approximately
$1.1 million, or 154%, compared to $0.8 million in the fiscal
quarter ended March 31, 2021. As is commonplace for early-stage
Pharma Services companies, the Company experiences significant
quarter-to-quarter revenue variability, driven by factors such as
the number and size of customer contracts, as well as the timing of
revenue recognition.
R&D and G&A expenses for the third
quarter of fiscal 2022 increased 157% and 60%, respectively, over
the comparable period in fiscal 2021. 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.
The Company’s consolidated net loss for the
third quarter ended March 31, 2022, was approximately $12.4
million, or $0.06 per share, compared to a net loss of
approximately $7.7 million, or $0.04 per share, in the same period
of 2021.
As of March 31, 2022, the Company had cash and
cash equivalents plus debt securities of approximately $48.6
million, excluding $5.9 million of restricted cash. Based on
management assumptions, including assumptions regarding the
sale-leaseback of the facility in Bryan, we continue to believe
that we have adequate cash to support our activities through
September 30, 2023.
Webcast and Conference Call
iBio management will host a webcast and
conference call at 4:30 p.m. Eastern Time today, May 12, 2022, 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: 2392536.
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 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 there being a notable
medical and business opportunity for our nucleocapsid-based
COVID-19 vaccine candidate, as the durability and efficacy of the
existing spike-based vaccines are called into question at the same
time as new waves of variants are forecasted to arrive; plans to
file an IND for IBIO-101 by the end of Q2 of calendar 2023 and be
in the clinic with IBIO-101 in calendar 2023; continuing to
demonstrate the quality of our FastPharming System
and potency-enhancing capability of our
Glycaneering Technology; the Company being
well-positioned to continue executing its growth strategy; filing
an IND application with FDA before the end of calendar 2022 for
IBIO-202; a response from the USDA on the submission for BIO-400
within approximately 12 months; having initial data from the
evaluation of the potential anti-cancer effects of the Company’s
endostatin E4 molecule in combination with other cancer treatments
upon fibrotic tumors in the second half of calendar year 2022; the
preferred stock placement providing an elegant solution to
implement the will of the Company’s voting stockholders; R&D
and G&A expenses continuing to increase with the rate of growth
moderating over time; and the Company having adequate cash to
support its activities through September 30, 2023. 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 file an IND
for IBIO-101 by the end of Q2 2023 and to be in the clinic with
IBIO-101 in calendar 2023: file an IND application with FDA before
the end of calendar 2022 for IBIO-202; receive a response from the
USDA on the submission for BIO-400 within approximately 12 months;
receiving initial data from the evaluation of the potential
anti-cancer effects of the Company’s endostatin E4 molecule in
combination with other cancer treatments upon fibrotic tumors in
the second half of calendar year 2022; its ability to provide a
solution to implement the will of the stockholders; 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; its ability to 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 increase its authorized shares; its
ability to retain its key employees or maintain its NYSE American
listing; 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
SubsidiariesCondensed Consolidated Balance
Sheets(In Thousands, except share and per share
amounts)
|
|
|
|
|
|
|
|
|
March 31, |
|
June 30, |
|
|
2022 |
|
2021 |
|
|
(Unaudited) |
|
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
33,767 |
|
|
$ |
77,404 |
|
Accounts receivable - trade |
|
|
1,004 |
|
|
|
426 |
|
Settlement receivable - current portion |
|
|
5,100 |
|
|
|
5,100 |
|
Investments in debt securities |
|
|
14,813 |
|
|
|
19,570 |
|
Inventory |
|
|
3,283 |
|
|
|
27 |
|
Prepaid expenses and other current assets |
|
|
2,349 |
|
|
|
2,070 |
|
Total Current Assets |
|
|
60,316 |
|
|
|
104,597 |
|
|
|
|
|
|
|
|
Restricted cash |
|
|
5,941 |
|
|
|
— |
|
Convertible promissory note
receivable and accrued interest |
|
|
1,612 |
|
|
|
1,556 |
|
Settlement receivable -
noncurrent portion |
|
|
— |
|
|
|
5,100 |
|
Finance lease right-of-use
assets, net of accumulated amortization |
|
|
86 |
|
|
|
26,111 |
|
Operating lease right-of-use
asset |
|
|
5,151 |
|
|
|
— |
|
Fixed assets, net of
accumulated depreciation |
|
|
34,581 |
|
|
|
8,628 |
|
Intangible assets, net of
accumulated amortization |
|
|
4,919 |
|
|
|
952 |
|
Investment in equity security
- at cost |
|
|
1,760 |
|
|
|
— |
|
Prepaid expenses -
noncurrent |
|
|
975 |
|
|
|
— |
|
Security deposits |
|
|
29 |
|
|
|
24 |
|
Total Assets |
|
$ |
115,370 |
|
|
$ |
146,968 |
|
|
|
|
|
|
|
|
Liabilities and Equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
5,279 |
|
|
$ |
2,254 |
|
Accrued expenses (related party of $0 and $701 as of
March 31, 2022 and June 30, 2021,
respectively) |
|
|
2,939 |
|
|
|
3,001 |
|
Finance lease obligations - current portion |
|
|
45 |
|
|
|
367 |
|
Operating lease obligation - current portion |
|
|
10 |
|
|
|
— |
|
Note payable - PPP loan - current portion |
|
|
— |
|
|
|
600 |
|
Contract liabilities |
|
|
8 |
|
|
|
423 |
|
Total Current Liabilities |
|
|
8,281 |
|
|
|
6,645 |
|
|
|
|
|
|
|
|
Finance lease obligations -
net of current portion |
|
|
41 |
|
|
|
31,755 |
|
Operating lease obligation -
net of current portion |
|
|
5,548 |
|
|
|
— |
|
Term note payable - net of
deferred financing costs |
|
|
22,120 |
|
|
|
— |
|
|
|
|
|
|
|
|
Total Liabilities |
|
|
35,990 |
|
|
|
38,400 |
|
|
|
|
|
|
|
|
Equity |
|
|
|
|
|
|
iBio, Inc. Stockholders’ Equity: |
|
|
|
|
|
|
Common stock - $0.001 par value; 275,000,000 shares authorized at
March 31, 2022 and June 30, 2021; 218,165,624
and 217,873,094 shares issued and outstanding as of March
31, 2022 and June 30, 2021, respectively |
|
|
218 |
|
|
|
217 |
|
Additional paid-in capital |
|
|
286,232 |
|
|
|
282,058 |
|
Accumulated other comprehensive loss |
|
|
(194 |
) |
|
|
(63 |
) |
Accumulated deficit |
|
|
(206,876 |
) |
|
|
(173,627 |
) |
Total iBio, Inc. Stockholders’ Equity |
|
|
79,380 |
|
|
|
108,585 |
|
Noncontrolling interest |
|
|
— |
|
|
|
(17 |
) |
Total Equity |
|
|
79,380 |
|
|
|
108,568 |
|
Total Liabilities and Equity |
|
$ |
115,370 |
|
|
$ |
146,968 |
|
iBio, Inc. and
SubsidiariesCondensed Consolidated Statements of
Operations and Comprehensive Loss(Unaudited; in Thousands,
except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
March 31, |
|
March 31, |
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
|
$ |
1,943 |
|
|
$ |
765 |
|
|
$ |
2,322 |
|
|
$ |
1,880 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
|
48 |
|
|
|
493 |
|
|
|
201 |
|
|
|
1,275 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
1,895 |
|
|
|
272 |
|
|
|
2,121 |
|
|
|
605 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
5,551 |
|
|
|
2,162 |
|
|
|
11,393 |
|
|
|
6,892 |
|
General and administrative (related party of $0, $491, $250 and
$1,394) |
|
|
8,526 |
|
|
|
5,313 |
|
|
|
23,522 |
|
|
|
15,385 |
|
Total operating expenses |
|
|
14,077 |
|
|
|
7,475 |
|
|
|
34,915 |
|
|
|
22,277 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(12,182 |
) |
|
|
(7,203 |
) |
|
|
(32,794 |
) |
|
|
(21,672 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense (related party of $0, $610, $810 and $1,836) |
|
|
(250 |
) |
|
|
(612 |
) |
|
|
(1,187 |
) |
|
|
(1,841 |
) |
Interest income |
|
|
40 |
|
|
|
152 |
|
|
|
111 |
|
|
|
183 |
|
Royalty income |
|
|
2 |
|
|
|
1 |
|
|
|
7 |
|
|
|
3 |
|
Forgiveness of note payable and accrued interest - SBA loan |
|
|
— |
|
|
|
— |
|
|
|
607 |
|
|
|
— |
|
Other |
|
|
— |
|
|
|
— |
|
|
|
6 |
|
|
|
— |
|
Total other (expense) |
|
|
(208 |
) |
|
|
(459 |
) |
|
|
(456 |
) |
|
|
(1,655 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated net loss |
|
|
(12,390 |
) |
|
|
(7,662 |
) |
|
|
(33,250 |
) |
|
|
(23,327 |
) |
Net loss attributable to noncontrolling interest |
|
|
— |
|
|
|
1 |
|
|
|
1 |
|
|
|
4 |
|
Net loss attributable to iBio,
Inc. |
|
|
(12,390 |
) |
|
|
(7,661 |
) |
|
|
(33,249 |
) |
|
|
(23,323 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock dividends |
|
|
— |
|
|
|
(64 |
) |
|
|
(88 |
) |
|
|
(195 |
) |
Net loss attributable to iBio,
Inc. stockholders |
|
$ |
(12,390 |
) |
|
$ |
(7,725 |
) |
|
$ |
(33,337 |
) |
|
$ |
(23,518 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated net loss |
|
$ |
(12,390 |
) |
|
$ |
(7,662 |
) |
|
$ |
(33,250 |
) |
|
$ |
(23,327 |
) |
Other comprehensive loss - unrealized loss on debt securities |
|
|
(103 |
) |
|
|
(16 |
) |
|
|
(131 |
) |
|
|
(36 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(12,493 |
) |
|
$ |
(7,678 |
) |
|
$ |
(33,381 |
) |
|
$ |
(23,363 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per common share
attributable to iBio, Inc. stockholders - basic and diluted |
|
$ |
(0.06 |
) |
|
$ |
(0.04 |
) |
|
$ |
(0.15 |
) |
|
$ |
(0.12 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares
outstanding - basic and diluted |
|
|
218,096 |
|
|
|
215,539 |
|
|
|
217,986 |
|
|
|
188,493 |
|
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