iBio, Inc. (NYSEA:IBIO) (“iBio” or the “Company”), a developer of
next-generation biopharmaceuticals and pioneer of the sustainable,
plant-based
FastPharming Manufacturing System®,
today announced its financial results for the fiscal fourth quarter
and year ended June 30, 2021.
“Fiscal 2021 was a transformative period for
iBio, highlighted by our entry into oncology and continued progress
as a next-gen COVID-19 vaccine developer,” said Tom Isett, Chairman
& CEO of iBio. “In the fiscal fourth quarter, we established
our new oncology drug discovery team in San Diego. Subsequently, we
entered into a partnership with FairJourney Biologics that provides
us access to proprietary antibodies and announced the addition of
three new anti-cancer targets to our pipeline. Then in August, we
announced an exclusive license agreement with RubrYc Therapeutics
for a second generation anti-CD25 antibody for the treatment of
solid tumors. This collaboration also provides us access to
RubrYc’s AI-driven antibody discovery platform, which should enable
iBio to develop multiple novel immuno-oncology targets. Coupled
with our FastPharming and
Glycaneering Technologies, we believe iBio is now
well positioned to capture discovery and development synergies
across these proprietary platforms, enabling us to further build
our pipeline of differentiated, next-gen oncology
therapeutics.”
“Although we are pleased to have executed on our
November promise to build a high-value oncology portfolio, we are
even more pleased to deliver results in other areas of our
Biopharmaceutical segment, especially our next-generation COVID-19
vaccine, IBIO-202. We believe that there is a critical need to
design new vaccines that can target regions of the virus aside from
the frequently mutating spike protein, in order to address the
looming risk of an escape variant. IBIO-202 could potentially
represent one such option, given that it targets the more highly
conserved nucleocapsid protein of SARS-CoV-2, and in preclinical
models of disease, drove robust memory T cell responses. We look
forward to updating investors on IBIO-202 after we receive feedback
on our pre-IND package, which was submitted earlier this
month.”
“While we were aggressively building our
Biopharmaceutical segment and recruiting our new Management Team in
FY21, we also grew our Bioprocess segment. Revenues in the Services
business were up 50% over prior year. We also established a new
‘Products’ business unit to further exploit our
FastPharming System and capabilities to deliver
greener products to researchers and biomanufacturers. All things
considered, this past year was one of exceptional achievement
towards creating a multifaceted business that fully leverages our
technologies and capabilities to help iBio and our customers
address unmet medical needs in the fields of oncology, fibrosis,
and infectious diseases.”
Fiscal Fourth Quarter and Recent Business
Developments:
BIOPHARMACEUTICAL SEGMENT
Therapeutics
- In June 2021,
iBio established a new drug discovery team based in San Diego.
- In July 2021,
iBio added three new antibody programs to its oncology drug
discovery pipeline.
- In August 2021,
the Company signed a definitive worldwide exclusive license
agreement with RubrYc Therapeutics, Inc., for a monoclonal antibody
candidate designed to deplete immunosuppressive regulatory T cells
from the tumor microenvironment. Additionally, iBio acquired an
equity stake in RubrYc along with an option to license antibodies
developed with RubrYc’s artificial intelligence (“AI”)-based
antibody discovery platform.
- iBio continues
pre-clinical development of IBIO-100. The Company expects to
initiate IND-enabling studies during FY2022.
- For regulatory
and business reasons, the Company discontinued development of its
discovery-stage ACE2-Fc project.
Vaccines
- In July 2021,
the Company reported robust, antigen-specific, memory T-cell
responses from preclinical studies of IBIO-202.
- In September
2021, iBio submitted a pre-IND package for IBIO-202 with the
expectation that a nucleocapsid-based protein subunit vaccine could
address several unmet needs that remain with first-generation
vaccines targeting the spike protein.
- The Company is
continuing to develop its Classical Swine Fever Vaccine, IBIO-400,
while concurrently seeking regulatory clearances for the animal
health markets.
BIOPROCESS SEGMENT
Services
- In May 2021,
iBio announced that it concluded its lawsuit with Fraunhofer USA,
Inc. One outcome of the settlement was that iBio received a $1.8
million fee in exchange for a license to Fraunhofer for use of
certain iBio trade secrets relating to the
FastPharming System. The Company expects to
recognize the license fee as Services revenues in the future.
Another outcome of the case was that iBio realized, net of legal
fees and other expenses, Settlement Income of $10.2 million.
- The Company
also announced in May an expanded menu of Bioanalytical Services,
including intact protein analysis, new proteomic assays, and
middle-down characterization for monoclonal antibodies.
Products
- In June 2021,
iBio launched a new line of growth factors, cytokines and lectins
via its new e-shop. The Company plans to add more
FastPharming-produced recombinant proteins to the
catalog over time, including monoclonal antibodies for research
that are scalable for cGMP bioprocessing uses.
Fiscal Fourth Quarter and Recent
Corporate Developments:
- Throughout
fiscal 2021 and FY22 year-to-date, iBio increased its bench
strength and enhanced its leadership team to support its growth
strategy. Overall staffing grew by approximately 60% to 87
employees, with new hiring focused in the areas of drug discovery,
process development, and finance. Between December and
March, the Executive Team was increased from one member to
five.
- In June 2021,
the Company further strengthened its Board of Directors with the
appointment of Evert (Eef) Schimmelpennink, who has a strong
history of success leading companies with novel protein expression
platforms to develop and commercialize biopharmaceutical
products.
- In August 2021,
iBio appointed William D. (Chip) Clark to its Board, adding deep
expertise in business management and immuno-oncology.
Also in August, Seymour Flug resigned from the Board.
- iBio recently
presented at the UBS Global Healthcare Virtual Conference and the
H.C. Wainwright 23rd Annual Global Investment Conference. Today,
the Company is scheduled to participate in a fireside chat at the
Cantor Virtual Global Healthcare Conference.
Financial Results:
Revenues for the fiscal
year ended June 30, 2021, were $2.4 million, an
increase of 50% over fiscal 2020. In the fourth quarter ended June
30, 2021, revenue was $0.5 million, a decrease of $0.6 million from
Q4 FY2020, and a decrease of $0.3 million from Q3 FY2021.
Significant quarter-to-quarter revenue variability is commonplace
for early-stage pharma services companies, given the relatively
small number of contracts and timing of revenue recognition. Based
upon the current outlook, iBio expects 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.
Irrespective of quarterly fluctuations, continued year-on-year
revenue growth is anticipated as the Bioprocess
businesses continue to attract interest from
organizations wishing to rapidly develop biologics using
more sustainable manufacturing methods.
R&D and G&A expenses for the fourth
quarter and full fiscal year 2021 increased significantly over the
comparable periods in fiscal year 2020. R&D expense was up $6.4
million to $10.0 million in fiscal 2021, with an increase of $2.5
million to $3.1 million in the fourth quarter. G&A expense was
up $10.6 million to $22.0 million in fiscal 2021, rising $3.5
million to $6.6 million in the fourth quarter. The growth in
R&D and G&A reflects the strategy to
invest in iBio’s proprietary biopharmaceutical
pipeline and platform technology. Across R&D and G&A,
the company invested in additional staff and made external
investments to implement its strategy. While iBio expects R&D
and G&A will continue to grow in fiscal 2022, it anticipates a
slower growth rate compared to fiscal 2021.
In the fourth quarter of fiscal
2021, iBio recorded $10.2 million in Settlement Income,
reflecting the value of settlement of litigation with
Fraunhofer. While iBio recognized this income in fiscal 2021,
actual payment by Fraunhofer will be made in two separate
payments of $5.1 million each in March 2022 and March
2023. Fraunhofer also agreed to pay iBio $1.8
million for a license to
iBio’s intellectual property. Revenue for that
license will be recognized when Fraunhofer pays for the
license in two installments of $0.9 million each, expected in March
2022 and March 2023.
iBio's consolidated net loss for fiscal 2021
ending June 30, 2021, was $23.2 million, an increase of $6.8
million compared to 2020. The increase in consolidated net loss
would have been greater except for the Settlement Income of $10.2
million recognized in the fourth quarter of 2021. iBio had a
consolidated net gain of $0.1 million in the fourth quarter because
of the Settlement Income versus a consolidated net loss in Q4
FY2020 of $3.5 million.
iBio had $97.0 million in
cash, marketable securities, and investments in debt
securities as of June 30, 2021. iBio used $30.1 million
in net cash for operating activities in fiscal 2021 versus net cash
used in operating activities of $13.3 million in 2020. Based on
current plans, iBio believes the current cash position is
sufficient to fund operations through the first
calendar quarter of 2023.
Webcast and Conference Call
iBio management will host a webcast and
conference call at 8:30 a.m. Eastern Time today, September 27,
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: 7159935.
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, antigens, and other proteins. iBio is
developing proprietary biopharmaceuticals for the treatment of
cancers, as well as fibrotic and infectious diseases. The Company’s
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 access to RubrYc’s
AI-driven anti-body discovery platform enabling the Company to
develop multiple novel immune-oncology targets, the Company being
positioned to capture discovery and development synergies across
its FastPharming® and
Glycaneering™ proprietary platforms, enabling it
to further build its pipeline of differentiated, next-gen oncology
therapeutics, the critical need to design new vaccines that target
regions of SARS-CoV-2 aside from the frequently mutating spike
proteins and the potential of IBIO-202 with respect thereto,
initiating IND-enabling studies of IBIO-100 for systemic
scleroderma during FY2022, the expectation that a
nucleocapsid-based protein subunit vaccine could address several
unmet needs that remain with first-generation vaccines targeting
the spike protein, plans to add more
FastPharming-produced recombinant proteins to the
Company’s catalog over time, including monoclonal antibodies for
research that are scalable for cGMP bioprocessing uses, the
expectation of 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 and
continued year-on-year revenue growth, expectation of continued
growth of R&D and G&A in fiscal 2022 at a slower growth
rate compared to fiscal 2021, current cash position being
sufficient to fund operations through the first calendar quarter of
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
including development of multiple novel immune-oncology targets,
development of IBIO-202 to successfully target regions of the
SARS-Co-V-2 aside from the frequently mutating spike proteins,
initiation of IND-enabling studies of IBIO-100 for systemic
scleroderma during FY2022 and the addition of
FastPharming-produced recombinant proteins to its
catalog, its 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 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, 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
facilities, 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 most recent Annual
Report on Form 10-K and the Company’s subsequent filings with the
SEC on Forms 10-Q and 8-K. Additional information will be set forth
in the Company’s Annual Report on Form 10-K for the year ended June
30, 2021. 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.
Contact:
Stephen KilmeriBio, Inc.Investor Relations(646)
274-3580skilmer@ibioinc.com
iBio, Inc. and
SubsidiariesConsolidated Balance
Sheets(In Thousands, except share and per share
amounts)
|
|
|
|
|
|
|
|
|
June 30, 2021 |
|
June 30, 2020 |
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
77,404 |
|
|
$ |
55,112 |
|
Accounts receivable -
trade |
|
|
426 |
|
|
|
75 |
|
Settlement receivable -
current portion |
|
|
5,100 |
|
|
|
— |
|
Subscription receivable |
|
|
— |
|
|
|
5,549 |
|
Investments in debt
securities |
|
|
19,570 |
|
|
|
— |
|
Work in progress |
|
|
27 |
|
|
|
798 |
|
Prepaid expenses and other
current assets |
|
|
2,070 |
|
|
|
214 |
|
Total Current Assets |
|
|
104,597 |
|
|
|
61,748 |
|
|
|
|
|
|
|
|
Note receivable and accrued
interest |
|
|
1,556 |
|
|
|
— |
|
Settlement receivable -
noncurrent portion |
|
|
5,100 |
|
|
|
— |
|
Finance lease right-of-use
assets, net of accumulated amortization |
|
|
26,111 |
|
|
|
27,616 |
|
Fixed assets, net of
accumulated depreciation |
|
|
8,628 |
|
|
|
3,657 |
|
Intangible assets, net of
accumulated amortization |
|
|
952 |
|
|
|
1,144 |
|
Security deposits |
|
|
24 |
|
|
|
24 |
|
Total Assets |
|
$ |
146,968 |
|
|
|
94,189 |
|
|
|
|
|
|
|
|
Liabilities and Equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable (related
parties of $0 and $6 as of June 30, 2021 and 2020,
respectively) |
|
$ |
2,254 |
|
|
$ |
1,759 |
|
Accrued expenses (related
party of $701 and $705 as of June 30, 2021 and 2020,
respectively) |
|
|
3,001 |
|
|
|
1,105 |
|
Finance lease obligations -
current portion |
|
|
367 |
|
|
|
301 |
|
Note payable - PPP loan -
current portion |
|
|
600 |
|
|
|
261 |
|
Deferred revenue / Contract
liabilities |
|
|
423 |
|
|
|
1,810 |
|
Total Current Liabilities |
|
|
6,645 |
|
|
|
5,236 |
|
|
|
|
|
|
|
|
Note payable - PPP loan - net
of current portion |
|
|
— |
|
|
|
339 |
|
Finance lease obligations -
net of current portion |
|
|
31,755 |
|
|
|
32,007 |
|
|
|
|
|
|
|
|
Total Liabilities |
|
|
38,400 |
|
|
|
37,582 |
|
|
|
|
|
|
|
|
Commitments and
Contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity |
|
|
|
|
|
|
iBio, Inc. Stockholders’
Equity: |
|
|
|
|
|
|
Common stock - $0.001 par
value; 275,000,000 shares authorized at June 30, 2021 and
2020; 217,873,094 and 140,071,110 shares issued and outstanding as
of June 30, 2021 and 2020, respectively |
|
|
217 |
|
|
|
140 |
|
Additional paid-in
capital |
|
|
282,058 |
|
|
|
206,931 |
|
Accumulated other
comprehensive loss |
|
|
(63 |
) |
|
|
(33 |
) |
Accumulated deficit |
|
|
(173,627 |
) |
|
|
(150,420 |
) |
Total iBio, Inc. Stockholders’
Equity |
|
|
108,585 |
|
|
|
56,618 |
|
Noncontrolling interest |
|
|
(17 |
) |
|
|
(11 |
) |
Total Equity |
|
|
108,568 |
|
|
|
56,607 |
|
Total Liabilities and
Equity |
|
$ |
146,968 |
|
|
|
94,189 |
|
iBio, Inc. and
SubsidiariesConsolidated Statements of Operations
and Comprehensive Loss(In Thousands, except per
share amounts)
|
|
|
|
|
|
|
|
|
Years Ended |
|
|
June 30, |
|
|
2021 |
|
|
2020 |
|
|
|
|
|
|
|
|
Revenues |
|
$ |
2,371 |
|
|
$ |
1,638 |
|
|
|
|
|
|
|
|
Cost of goods sold |
|
|
1,462 |
|
|
|
703 |
|
|
|
|
|
|
|
|
Gross profit |
|
|
909 |
|
|
|
935 |
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
Research and development
(related party of $0 and $97) |
|
|
9,989 |
|
|
|
3,573 |
|
General and administrative
(related party of $1,587 and $1,143) |
|
|
22,031 |
|
|
|
11,365 |
|
Total operating expenses |
|
|
32,020 |
|
|
|
14,938 |
|
|
|
|
|
|
|
|
Operating loss |
|
|
(31,111 |
) |
|
|
(14,003 |
) |
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
Interest income |
|
|
140 |
|
|
|
15 |
|
Interest expense (related
party of $2,446 and $2,466) |
|
|
(2,454 |
) |
|
|
(2,466 |
) |
Royalty income |
|
|
12 |
|
|
|
10 |
|
Settlement income |
|
|
10,200 |
|
|
|
— |
|
Total other income
(expense) |
|
|
7,898 |
|
|
|
(2,441 |
) |
|
|
|
|
|
|
|
Consolidated net loss |
|
|
(23,213 |
) |
|
|
(16,444 |
) |
Net loss attributable to
noncontrolling interest |
|
|
6 |
|
|
|
5 |
|
Net loss attributable to iBio,
Inc. |
|
|
(23,207 |
) |
|
|
(16,439 |
) |
|
|
|
|
|
|
|
Deemed dividends – down round
of Series A Preferred and Series B Preferred |
|
|
— |
|
|
|
(21,560 |
) |
Preferred stock dividends –
iBio CMO Tracking Stock |
|
|
(260 |
) |
|
|
(261 |
) |
Net loss attributable to iBio,
Inc. stockholders |
|
$ |
(23,467 |
) |
|
$ |
(38,260 |
) |
|
|
|
|
|
|
|
Comprehensive loss: |
|
|
|
|
|
|
Consolidated net loss |
|
$ |
(23,213 |
) |
|
$ |
(16,444 |
) |
Other comprehensive loss -
unrealized loss on debt securities |
|
|
(29 |
) |
|
|
— |
|
Other comprehensive loss -
foreign currency translation adjustments |
|
|
(1 |
) |
|
|
(2 |
) |
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(23,243 |
) |
|
$ |
(16,446 |
) |
|
|
|
|
|
|
|
Loss per common share
attributable to iBio, Inc. stockholders - basic and diluted |
|
$ |
(0.12 |
) |
|
$ |
(0.61 |
) |
|
|
|
|
|
|
|
Weighted-average common shares
outstanding - basic and diluted |
|
|
195,620 |
|
|
|
62,795 |
|
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