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
December 31, 2021 and provides a corporate update.
“We are pleased to report that we have now added
six new immuno-oncology assets to our pipeline in the six months
since we announced our new drug discovery capabilities,” said Tom
Isett, Chairman & CEO of iBio. “Our most recent addition
progressed the fastest, already advancing into late-discovery stage
thanks to our deployment of artificial intelligence design
capabilities. We are also leveraging our research on a novel
peptide with anti-fibrotic effects into oncology by exploring its
possible use in treating solid tumors with a strong fibrotic
matrix. Meanwhile, we are in position to move our second-generation
COVID-19 vaccine candidate towards the clinic and potentially
address many of the unmet needs that remain in the fight against
COVID-19 as it transitions to an endemic disease. Overall, we are
elated to see in this quarter multiple new pipeline additions and
advancements as a result of our recent investments in drug
discovery R&D.”
Second Quarter and Recent Business
Developments:
BIOPHARMACEUTICALS
Vaccines
- In light of the waning periods of SARS-CoV-2 immunity provided
by commercially available first-generation vaccines that are all
based upon the virus’ frequently changing spike protein, the
Company is moving forward with IND-Enabling studies of IBIO-202 in
an attempt to bring a more durable COVID-19 vaccine to market.
Pending the outcome of those studies, iBio plans to file an IND
application for its nucleocapsid-based, intramuscularly delivered
vaccine candidate with the U.S. Food and Drug Administration before
the end of calendar 2022.
- iBio is continuing to work with a leading innovator of
microarray patch systems to evaluate the feasibility of intradermal
delivery of its vaccine candidates.
- The Company continues to advance IBIO-400, which has the
potential to be the first fully approved vaccine for Classical
Swine Fever, an agricultural biothreat that poses a significant
risk to domestic food security and the multi-billion dollar U.S.
pork export market. The life-phase of the oral immunogenicity study
of IBIO-400 has been completed. Next steps will be determined
following data analysis.
Therapeutics
- To better assist investors in tracking iBio’s progress with its
biopharmaceutical candidates, it will now classify its discovery
programs into four stages: (1) Early Discovery; (2) Late Discovery;
(3) Lead Optimization; and (4), Investigational New Drug
(“IND”)-Enabling. In that regard, the Company announced today that
‘immuno-oncology Target 3’ and ‘AI-driven immuno-oncology Target 6’
successfully advanced into the Late Discovery stage.
- iBio continues to develop its IL-2 sparing anti-CD25 antibody,
IBIO-101, on the FastPharming Platform. The
Company anticipates the program will advance from Lead Optimization
to IND-Enabling before the middle of calendar 2022.
- The Company’s endostatin E4 molecule for fibrotic diseases,
IBIO-100, is subject to an exclusive, worldwide license to certain
patents and related intellectual property granted to it by the
University of Pittsburgh. Last week, the parties signed an amended
license agreement that extends several milestone-related deadlines.
Given the additional flexibility provided by the amended agreement
and the effort to balance positive developments with IBIO-202 and
its oncology portfolio with cash management objectives, the Company
has decided to appropriately pace the progression of IBIO-100
through the Lead Optimization stage.
- In November 2021, iBio announced a research collaboration with
the University of Texas Southwestern Medical Center to evaluate the
potential effects the endostatin E4 molecule may have upon fibrotic
tumors in combination with other cancer treatments. Initial data
from the collaboration is expected in the second half of calendar
2022.
BIOPROCESS
- In November
2021, iBio purchased three assets for approximately $28.7 million
from two affiliates of Eastern Capital Limited (the “Eastern
Affiliates”). One asset is the Bryan, Texas,
FastPharming Manufacturing Facility, which it
previously operated under a lease from the Eastern Affiliates.
Another is the rights to develop the adjacent land using the ground
lease from Texas A&M University. The third asset was the iBio
CMO Preferred Tracking Stock held by the Eastern Affiliates, which
represented their approximately 30% equity interest in the
jointly-owned subsidiary, iBio CDMO LLC, iBio continues to evaluate
options with respect to the acquired assets, including a potential
sale-leaseback transaction for the facility.
Second 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 were insufficient for them to pass.
“We were pleased by the support we received for
each of these proposals,” said Mr. Isett. “Stockholders who chose
to vote their shares did so in favor of Proposals 4 and 5 by a
large margin of approximately 2-to-1. We will continue to work on
solutions to overcome structural impediments to implementing the
will of our voting stockholders and, more broadly, to ensure iBio
is in position to continue to grow. In the meantime, we have made a
number of adjustments to our operating and development plans in
order to achieve our cash management objectives. These changes
include deferring a number of planned new hires as well as less
aggressively advancing the IBIO-100 program, to name a few. The
adjustments will allow us to extend our cash runway by two quarters
while still advancing IBIO-202 and other key Biopharmaceutical and
Bioprocess initiatives.”
Financial Results:
Revenues for the second quarter ended December
31, 2021, were approximately $0.2 million, which was not a
significant change from the prior quarter and a decrease of 76%
from approximately $0.7 million in the same period of 2020. As is
commonplace for early-stage Pharma Services companies, iBio has
experienced 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. As
previously communicated, the Company expects revenue growth to
return in the second half of fiscal 2022.
R&D and G&A expenses for the second
quarter of fiscal 2022 increased 40% and 48%, 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.
The Company’s consolidated net loss for the
second quarter ended December 31, 2021, was approximately $11.9
million, or $0.05 per share, compared to a net loss of
approximately $8.2 million, or $0.04 per share, in the same period
of 2020.
As of December 31, 2021, iBio had cash and cash
equivalents plus debt securities of approximately $57.4 million,
excluding $5.9 million of restricted cash. The Company now believes
that it has adequate cash to support its 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, February 14, 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: 3527478.
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 leveraging IBio’s
research on a novel peptide with anti-fibrotic effects into
oncology by exploring its possible use in treating solid tumors
with a strong fibrotic matrix; the potential of iBio’s second
generation COVID-19 vaccine candidate to address many of the unmet
needs that remain in the fight against COVID-19; the potential of
IBIO-400 to be the first fully approved vaccine for Classical Swine
Fever; plans to file an IND application for IBIO-202 with the U.S.
Food and Drug Administration before the end of calendar 2022;
continuing to advance its IL-2 sparing anti-CD25 antibody,
IBIO-101, and moving the program from the Lead Optimization to
IND-Enabling stage before the middle of calendar 2022; the
potential effects of the endostatin E4 molecule upon fibrotic
tumors in combination with other cancer treatments and initial data
from the collaboration with the University of Texas Southwestern
Medical Center expected in the second half of calendar 2022; a
potential sale-leaseback transaction; revenue growth returning in
the second half of fiscal 2022; R&D and G&A expenses
continuing to increase, however, the rate of growth becoming
moderate over time; and iBio 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 successfully
implement its development plans and continue to accelerate the
execution of its growth strategy, including the ability to move
product candidates, such as IBIO-101 and IBIO-202 into Late
Discovery stage and initiate IND-Enabling studies as planned; 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 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
SubsidiariesCondensed Consolidated Balance
Sheets(In Thousands, except share and per share
amounts)
|
|
|
|
|
|
|
|
|
December 31, |
|
June 30, |
|
|
2021 |
|
|
2021 |
|
|
|
(Unaudited) |
|
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
39,205 |
|
|
$ |
77,404 |
|
Accounts receivable - trade |
|
|
111 |
|
|
|
426 |
|
Settlement receivable - current portion |
|
|
5,100 |
|
|
|
5,100 |
|
Investments in debt securities |
|
|
18,172 |
|
|
|
19,570 |
|
Inventory |
|
|
1,986 |
|
|
|
27 |
|
Prepaid expenses and other current assets |
|
|
2,922 |
|
|
|
2,070 |
|
Total Current Assets |
|
|
67,496 |
|
|
|
104,597 |
|
|
|
|
|
|
|
|
Restricted cash |
|
|
5,940 |
|
|
|
— |
|
Convertible promissory note
receivable and accrued interest |
|
|
1,594 |
|
|
|
1,556 |
|
Settlement receivable -
noncurrent portion |
|
|
5,100 |
|
|
|
5,100 |
|
Finance lease right-of-use
assets, net of accumulated amortization |
|
|
109 |
|
|
|
26,111 |
|
Operating lease right-of-use
asset |
|
|
5,291 |
|
|
|
— |
|
Fixed assets, net of
accumulated depreciation |
|
|
32,881 |
|
|
|
8,628 |
|
Intangible assets, net of
accumulated amortization |
|
|
5,041 |
|
|
|
952 |
|
Investment in equity security
- at cost |
|
|
1,760 |
|
|
|
— |
|
Prepaid expenses -
noncurrent |
|
|
1,195 |
|
|
|
— |
|
Security deposits |
|
|
41 |
|
|
|
24 |
|
Total Assets |
|
$ |
126,448 |
|
|
$ |
146,968 |
|
|
|
|
|
|
|
|
Liabilities and Equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
2,739 |
|
|
$ |
2,254 |
|
Accrued expenses (related party of $0 and $701 as of
December 31, 2021 and June 30, 2021,
respectively) |
|
|
2,842 |
|
|
|
3,001 |
|
Acquisition Payable |
|
|
2,500 |
|
|
|
— |
|
Finance lease obligations - current portion |
|
|
45 |
|
|
|
367 |
|
Operating lease obligation - current portion |
|
|
160 |
|
|
|
— |
|
Note payable - PPP loan - current portion |
|
|
— |
|
|
|
600 |
|
Contract liabilities |
|
|
60 |
|
|
|
423 |
|
Total Current Liabilities |
|
|
8,346 |
|
|
|
6,645 |
|
|
|
|
|
|
|
|
Finance lease obligations -
net of current portion |
|
|
51 |
|
|
|
31,755 |
|
Operating lease obligation -
net of current portion |
|
|
5,400 |
|
|
|
— |
|
Term note payable - net of
deferred financing costs |
|
|
22,053 |
|
|
|
— |
|
|
|
|
|
|
|
|
Total Liabilities |
|
|
35,850 |
|
|
|
38,400 |
|
|
|
|
|
|
|
|
Equity |
|
|
|
|
|
|
iBio, Inc. Stockholders’ Equity: |
|
|
|
|
|
|
Common stock - $0.001 par value; 275,000,000 shares authorized at
December 31, 2021 and June 30, 2021;
218,060,597 and 217,873,094 shares issued and outstanding as of
December 31, 2021 and June 30, 2021,
respectively |
|
|
218 |
|
|
|
217 |
|
Additional paid-in capital |
|
|
284,957 |
|
|
|
282,058 |
|
Accumulated other comprehensive loss |
|
|
(91 |
) |
|
|
(63 |
) |
Accumulated deficit |
|
|
(194,486 |
) |
|
|
(173,627 |
) |
Total iBio, Inc. Stockholders’ Equity |
|
|
90,598 |
|
|
|
108,585 |
|
Noncontrolling interest |
|
|
— |
|
|
|
(17 |
) |
Total Equity |
|
|
90,598 |
|
|
|
108,568 |
|
Total Liabilities and Equity |
|
$ |
126,448 |
|
|
$ |
146,968 |
|
|
|
|
|
|
|
|
|
|
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, |
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
|
$ |
168 |
|
|
$ |
705 |
|
|
$ |
379 |
|
|
$ |
1,115 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
|
113 |
|
|
|
211 |
|
|
|
153 |
|
|
|
318 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
55 |
|
|
|
494 |
|
|
|
226 |
|
|
|
797 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
3,331 |
|
|
|
2,374 |
|
|
|
5,842 |
|
|
|
4,236 |
|
General and administrative (related party of $61, $510, $250 and
$903) |
|
|
8,362 |
|
|
|
5,665 |
|
|
|
14,996 |
|
|
|
11,030 |
|
Total operating expenses |
|
|
11,693 |
|
|
|
8,039 |
|
|
|
20,838 |
|
|
|
15,266 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(11,638 |
) |
|
|
(7,545 |
) |
|
|
(20,612 |
) |
|
|
(14,469 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense (related party of $202, $612, $810 and
$1,226) |
|
|
(328 |
) |
|
|
(615 |
) |
|
|
(937 |
) |
|
|
(1,229 |
) |
Interest income |
|
|
35 |
|
|
|
27 |
|
|
|
71 |
|
|
|
31 |
|
Royalty income |
|
|
5 |
|
|
|
2 |
|
|
|
5 |
|
|
|
2 |
|
Forgiveness of note payable and accrued interest - SBA loan |
|
|
— |
|
|
|
— |
|
|
|
607 |
|
|
|
— |
|
Other |
|
|
6 |
|
|
|
— |
|
|
|
6 |
|
|
|
— |
|
Total other income (expense) |
|
|
(282 |
) |
|
|
(586 |
) |
|
|
(248 |
) |
|
|
(1,196 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated net loss |
|
|
(11,920 |
) |
|
|
(8,131 |
) |
|
|
(20,860 |
) |
|
|
(15,665 |
) |
Net loss attributable to noncontrolling interest |
|
|
— |
|
|
|
2 |
|
|
|
1 |
|
|
|
3 |
|
Net loss attributable to iBio,
Inc. |
|
|
(11,920 |
) |
|
|
(8,129 |
) |
|
|
(20,859 |
) |
|
|
(15,662 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock dividends |
|
|
(22 |
) |
|
|
(65 |
) |
|
|
(88 |
) |
|
|
(131 |
) |
Net loss attributable to iBio,
Inc. stockholders |
|
$ |
(11,942 |
) |
|
$ |
(8,194 |
) |
|
$ |
(20,947 |
) |
|
$ |
(15,793 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated net loss |
|
$ |
(11,920 |
) |
|
$ |
(8,131 |
) |
|
$ |
(20,860 |
) |
|
$ |
(15,665 |
) |
Other comprehensive loss - unrealized loss on debt securities |
|
|
(27 |
) |
|
|
(13 |
) |
|
|
(28 |
) |
|
|
(20 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(11,947 |
) |
|
$ |
(8,144 |
) |
|
$ |
(20,888 |
) |
|
$ |
(15,685 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per common share
attributable to iBio, Inc. stockholders - basic and diluted |
|
$ |
(0.05 |
) |
|
$ |
(0.04 |
) |
|
$ |
(0.10 |
) |
|
$ |
(0.09 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares
outstanding - basic and diluted |
|
|
217,990 |
|
|
|
188,087 |
|
|
|
217,933 |
|
|
|
175,264 |
|
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