iBio, Inc. (NYSEA:IBIO) (“iBio” or the “Company”), a biotech
innovator and biologics contract manufacturing organization, today
announced its financial results for the fiscal quarter ended March
31, 2021.
“Our focus on strategy execution was reflected
in our third quarter results as we advanced our second-generation
COVID-19 vaccine candidate, defended our intellectual property
rights, and achieved strong year-over-year revenue growth while
adding new development services clients,” said Tom Isett, Chairman
& CEO of iBio. “Also, more recently, we saw continued progress
on new product and pipeline additions, including line extensions to
our Bioanalytical Services offering, and a planned investment in
the establishment of a new Drug Discovery team. Importantly, we
believe that when our new discovery capabilities are installed, we
will be able to more fully leverage the many ‘speed-to-clinic’
advantages conveyed by our proprietary
FastPharming® System.”
Fiscal Third Quarter and Recent Business
Developments:
Vaccines
- In May
2021, iBio reported on development of IBIO-202, a subunit vaccine
candidate that targets the nucleocapsid protein (“N protein”) of
SARS-CoV-2. Using its FastPharming System, iBio
has successfully expressed N protein antigens and has initiated
both intramuscular and intranasal preclinical studies to evaluate
antigen-adjuvant combinations that may provide strong T-cell memory
and immune responses. Initial results are expected in early Q1
FY2022.
- The
Company also announced that IBIO-201, its COVID-19 vaccine
candidate combining antigens derived from the spike protein (“S
protein”) fused with its patented LicKM™
Immunostimulator, had completed IND-enabling toxicology studies,
with no adverse effects observed at low or high doses.
- In
support of approval for production of its lead animal health
product candidate, IBIO-400, the Company submitted an “Outline of
Production” and facility documentation to the U.S. Department of
Agriculture for review.
Therapeutics
- Today,
iBio announced its plans to establish drug discovery capabilities
in the San Diego, CA, area, with an initial focus upon monoclonal
antibodies for use in oncology.
- The
Company continued pre-clinical development of IBIO-100, with
initiation of IND-enabling studies expected in FY 2022.
Contract Development and Manufacturing (“CDMO”)
Services
- In May
2021, iBio announced that it concluded its lawsuit with Fraunhofer
USA, Inc. (“Fraunhofer USA”) as described in full detail in the
Company’s Current Report on Form 8-K filed with the U.S. Securities
and Exchange Commission on May 4, 2021.
- Today,
iBio announced an expanded menu of Bioanalytical Services,
including intact protein analysis, new proteomic assays and
middle-down characterization for monoclonal antibodies. The
Company’s Bioanalytical Services were previously available only to
FastPharming Development and Manufacturing
Services clients, but are now available to biologics developers
using alternative protein expression systems.
Research & Bioprocess Products
- iBio continues
to make progress towards launching certain cytokines and growth
factors as part of a new catalog of products for research and
further manufacturing uses.
“We are excited about the advancement of a
differentiated second-generation COVID-19 vaccine candidate,” said
Mr. Isett. “Additionally, we are pleased with the protection of -
and compensation for - our IP in plant-based biologics, as we
further develop our FastPharming Technologies.
Moreover, we continue to see increased demand from new and existing
customers for our CDMO Services, even while we are in the midst of
our transformation.”
With reference to the Company’s planned
establishment of in-house drug discovery capabilities, Mr. Isett
commented, “We believe that our investment in fast, translatable
drug discovery activities will enable us to optimally leverage our
FastPharming System to create a robust pipeline of
truly innovative molecules and fast-followers, particularly in the
field of oncology.”
Fiscal Third Quarter and Recent
Corporate Developments:
- Fiscal
year to-date, iBio increased staffing by approximately 21% to 57
employees.
- During
the fiscal third quarter, iBio further strengthened its leadership
team with the additions of Dr. Martin B. Brenner as Chief
Scientific Officer and Mr. Robert M. Lutz as Chief Financial
& Business Officer, effective January 18 and March 4, 2021,
respectively.
“The key additions of Martin and Rob - along
with the recruitment of many talented new employees to our R&D
and Operations functions - reflect the ongoing rapid and successful
transformation of iBio,” said Mr. Isett. “By further
expanding the capabilities of our team this quarter, we delivered
new pipeline candidates, new service products and continued to
advance other key initiatives. Clearly, our ability to execute and
deliver value to shareholders has been further elevated this
quarter, and we expect that the investment in the new Drug
Discovery Team will yield significant returns as we seek to make
the FastPharming System the bioprocess
platform-of-choice.”
Financial Results:
For the fiscal quarter ended March 31, 2021,
iBio reported revenues of approximately $0.8 million, an increase
of $0.7 million from $0.1 million in the fiscal quarter ended March
31, 2020.
To further clarify the results of its operations
for investors, from this quarter forward, iBio will include Cost of
Goods Sold (“COGS”) and Gross Profit line items in its financial
statements. For the three-months ended March 31, 2021, iBio
reported COGS of approximately $0.5 million and gross profit of
$0.3 million, compared to COGS of $0.1 million and gross profit
that was not significant for the three months ended March 31, 2020.
Since iBio’s revenue is currently derived from a small number of
contracts, and revenue recognition from development and
manufacturing services is generally subject to volatility due to
timing, the Company expects that gross profit and gross profit
percentage may fluctuate significantly from quarter to quarter.
R&D expenses for the fiscal quarter ended
March 31, 2021 were approximately $2.2 million, compared with
approximately $1.1 million in the same period of 2020. The increase
in R&D expense of approximately $1.1 million was primarily
related to increases in personnel and other expenses to support the
Company’s development of a portfolio of proprietary therapeutics
and vaccines.
G&A expenses for the fiscal quarter ended
March 31, 2021 were approximately $5.3 million, compared with
approximately $3.0 million in the same period of 2020. The increase
of approximately $2.3 million resulted primarily from increased
headcount and increased operations to support the growth of the
business.
Net loss attributable to iBio stockholders for
the fiscal quarter ended March 31, 2021 was approximately $7.7
million, or $0.04 per share. This compared with a net loss of
approximately $4.7 million, or $0.06 per share, in the same period
of 2020.
iBio had $103.9 million in cash, cash
equivalents and debt investments as of March 31, 2021. The Company
further strengthened its financial position through the
aforementioned settlement of litigation with Fraunhofer USA. The
Company believes it will have sufficient resources to fund its
planned operations at least through March 31, 2023, inclusive of
its planned investment in the FastPharming
Discovery Platform and potential in-licensing activities.
Webcast and Conference Call
iBio management will host a webcast and
conference call at 8:00 a.m. Eastern Time today, May 17, 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: 3085726.
About iBio, Inc.
iBio is a global leader in 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 products on the FastPharming Platform,
which include biopharmaceuticals for the treatment of fibrotic and
infectious diseases, amongst others. The Company’s subsidiary, iBio
CDMO LLC, provides FastPharming Contract
Development and Manufacturing Services, including
Glycaneering™ Development Services for advanced
recombinant protein design. For more information, visit
www.ibioinc.com.
FORWARD-LOOKING
STATEMENTSCertain 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 the planned investment
in the establishment of a new Drug Discovery team, being able to
more fully leverage the many ‘speed-to-clinic’ advantages conveyed
by its proprietary FastPharming® System, the
planned establishment of drug discovery capabilities in San Diego,
initiation of IND-enabling studies of IBIO-100 in FY 2022, the
investment in fast, translatable drug discovery activities enabling
the Company to optimally leverage its FastPharming
System to create a robust pipeline of truly innovative molecules
and fast-followers, particularly in the field of oncology, and the
investment in the new Drug Discovery Team yielding significant
returns as the Company seeks to make the
FastPharming System the bioprocess
platform-of-choice. 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 ability to establish of a new Drug
Discovery team, the ability to successfully leverage the many
‘speed-to-clinic’ advantages conveyed by its proprietary
FastPharming System, the ability to establish drug
discovery capabilities in San Diego, the ability to initiate
IND-enabling studies of IBIO-100 in FY 2022, the Company’s ability
to apply its investment in fast, translatable drug discovery
activities to optimally leverage its FastPharming
System to create a robust pipeline of truly innovative molecules
and fast-followers, the Company’s ability to make the
FastPharming System the bioprocess
platform-of-choice, the Company’s 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 the Company’s product
candidates for specific indications, acceptance of the Company’s
product candidates in the marketplace and the successful
development, marketing or sale of the Company’s products, the
Company’s ability to maintain its license agreements, the continued
maintenance and growth of its intellectual property portfolio, the
Company’s ability to establish and maintain collaborations, the
Company’s ability to obtain or maintain the capital or grants
necessary to fund its research and development activities,
competition, the Company’s ability to retain its key employees or
maintain its NYSE American listing, and the other risk factors
discussed in the Company’s most recent Annual Report on Form 10-K
and the Company’s subsequent filings with the SEC, including
subsequent periodic reports on Forms 10-Q and 8-K. 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.
Contacts:
Stephen KilmeriBio, Inc.Investor Relations(646)
274-3580 skilmer@ibioinc.com
iBio, Inc. and
SubsidiariesCondensed Consolidated Balance
Sheets(In Thousands, except share and per share
amounts)
|
|
|
|
|
|
|
|
|
|
March 31, |
|
June 30, |
|
|
|
2021 |
|
|
2020 |
|
|
|
|
(Unaudited) |
|
(See Note 2) |
|
Assets |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
84,627 |
|
|
$ |
55,112 |
|
|
Accounts receivable - trade |
|
|
387 |
|
|
|
75 |
|
|
Accounts receivable - unbilled |
|
|
1 |
|
|
|
— |
|
|
Subscription receivable |
|
|
— |
|
|
|
5,549 |
|
|
Investments in debt securities |
|
|
19,296 |
|
|
|
— |
|
|
Work in process |
|
|
432 |
|
|
|
798 |
|
|
Prepaid expenses and other current assets |
|
|
2,460 |
|
|
|
214 |
|
|
Total Current Assets |
|
|
107,203 |
|
|
|
61,748 |
|
|
|
|
|
|
|
|
|
|
Note receivable and accrued
interest |
|
|
1,537 |
|
|
|
— |
|
|
Finance lease right-of-use
assets, net of accumulated amortization |
|
|
26,380 |
|
|
|
27,616 |
|
|
Fixed assets, net of
accumulated depreciation |
|
|
6,407 |
|
|
|
3,657 |
|
|
Intangible assets, net of
accumulated amortization |
|
|
1,146 |
|
|
|
1,144 |
|
|
Security deposit |
|
|
24 |
|
|
|
24 |
|
|
Total Assets |
|
$ |
142,697 |
|
|
$ |
94,189 |
|
|
|
|
|
|
|
|
|
|
Liabilities and Equity |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable (related parties of $100 and $6 as of
March 31, 2021 and June 30, 2020,
respectively) |
|
$ |
1,631 |
|
|
$ |
1,759 |
|
|
Accrued expenses (related party of $842 and $705 as of
March 31, 2021 and June 30, 2020,
respectively) |
|
|
2,666 |
|
|
|
1,105 |
|
|
Finance lease obligation – current portion |
|
|
318 |
|
|
|
301 |
|
|
Note payable – PPP loan – current portion |
|
|
566 |
|
|
|
261 |
|
|
Deferred revenue / Contract liabilities |
|
|
886 |
|
|
|
1,810 |
|
|
Total Current Liabilities |
|
|
6,067 |
|
|
|
5,236 |
|
|
|
|
|
|
|
|
|
|
Note payable – PPP Loan – net
of current portion |
|
|
34 |
|
|
|
339 |
|
|
Finance lease obligation – net
of current portion |
|
|
31,766 |
|
|
|
32,007 |
|
|
|
|
|
|
|
|
|
|
Total Liabilities |
|
|
37,867 |
|
|
|
37,582 |
|
|
|
|
|
|
|
|
|
|
Commitments and
Contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity |
|
|
|
|
|
|
|
iBio, Inc. Stockholders’ Equity: |
|
|
|
|
|
|
|
Preferred stock – no par value; 1,000,000 shares authorized; |
|
|
|
|
|
|
|
iBio CMO Preferred Tracking Stock; 1 share authorized, issued and
outstanding as of both March 31, 2021 and
June 30, 2020 |
|
|
— |
|
|
|
— |
|
|
Series B Convertible Preferred Stock - $1,000 stated value; 5,785
shares authorized; 0 and 5,785 shares issued and outstanding as of
March 31, 2021 and June 30, 2020,
respectively |
|
|
— |
|
|
|
— |
|
|
Common stock - $0.001 par value; 275,000,000 and 275,000,000 shares
authorized at March 31, 2021 and June 30, 2020,
respectively; 216,133,544 and 140,071,110 shares issued and
outstanding as of March 31, 2021 and
June 30, 2020, respectively |
|
|
216 |
|
|
|
140 |
|
|
Additional paid-in capital |
|
|
278,442 |
|
|
|
206,931 |
|
|
Accumulated other comprehensive loss |
|
|
(70 |
) |
|
|
(33 |
) |
|
Accumulated deficit |
|
|
(173,743 |
) |
|
|
(150,420 |
) |
|
Total iBio, Inc. Stockholders’ Equity |
|
|
104,845 |
|
|
|
56,618 |
|
|
Noncontrolling interest |
|
|
(15 |
) |
|
|
(11 |
) |
|
Total Equity |
|
|
104,830 |
|
|
|
56,607 |
|
|
Total Liabilities and Equity |
|
$ |
142,697 |
|
|
$ |
94,189 |
|
|
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, |
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
|
$ |
765 |
|
|
$ |
96 |
|
|
$ |
1,880 |
|
|
$ |
518 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
|
493 |
|
|
|
86 |
|
|
|
1,275 |
|
|
|
404 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
272 |
|
|
|
10 |
|
|
|
605 |
|
|
|
114 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development (related party of $0, $0, $0 and $97) |
|
|
2,162 |
|
|
|
1,095 |
|
|
|
6,892 |
|
|
|
2,990 |
|
|
General and administrative (related party of $491, $316, $1,394 and
$941) |
|
|
5,313 |
|
|
|
2,979 |
|
|
|
15,385 |
|
|
|
8,198 |
|
|
Total operating expenses |
|
|
7,475 |
|
|
|
4,074 |
|
|
|
22,277 |
|
|
|
11,188 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(7,203 |
) |
|
|
(4,064 |
) |
|
|
(21,672 |
) |
|
|
(11,074 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense (related party of $610, $616, $1,836 and
$1,851) |
|
|
(612 |
) |
|
|
(616 |
) |
|
|
(1,841 |
) |
|
|
(1,851 |
) |
|
Interest income |
|
|
152 |
|
|
|
4 |
|
|
|
183 |
|
|
|
12 |
|
|
Royalty income |
|
|
1 |
|
|
|
— |
|
|
|
3 |
|
|
|
9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income (expense) |
|
|
(459 |
) |
|
|
(612 |
) |
|
|
(1,655 |
) |
|
|
(1,830 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated net loss |
|
|
(7,662 |
) |
|
|
(4,676 |
) |
|
|
(23,327 |
) |
|
|
(12,904 |
) |
|
Net loss attributable to noncontrolling interest |
|
|
1 |
|
|
|
— |
|
|
|
4 |
|
|
|
3 |
|
|
Net loss attributable to iBio,
Inc. |
|
|
(7,661 |
) |
|
|
(4,676 |
) |
|
|
(23,323 |
) |
|
|
(12,901 |
) |
|
Deemed dividends – down round
of Series A Preferred and Series B Preferred |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(21,560 |
) |
|
Preferred stock dividends – iBio CMO Tracking Stock |
|
|
(64 |
) |
|
|
(65 |
) |
|
|
(195 |
) |
|
|
(196 |
) |
|
Net loss attributable to iBio,
Inc. stockholders |
|
$ |
(7,725 |
) |
|
$ |
(4,741 |
) |
|
$ |
(23,518 |
) |
|
$ |
(34,657 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated net loss |
|
$ |
(7,662 |
) |
|
$ |
(4,676 |
) |
|
$ |
(23,327 |
) |
|
$ |
(12,904 |
) |
|
Other comprehensive loss - unrealized loss on debt securities |
|
|
(16 |
) |
|
|
— |
|
|
|
(36 |
) |
|
|
— |
|
|
Other comprehensive loss - foreign currency translation
adjustments |
|
|
— |
|
|
|
(1 |
) |
|
|
— |
|
|
|
(2 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(7,678 |
) |
|
$ |
(4,677 |
) |
|
$ |
(23,363 |
) |
|
$ |
(12,906 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per common share
attributable to iBio, Inc. stockholders - basic and diluted |
|
$ |
(0.04 |
) |
|
$ |
(0.06 |
) |
|
$ |
(0.12 |
) |
|
$ |
(0.74 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares
outstanding - basic and diluted |
|
|
215,539 |
|
|
|
79,917 |
|
|
|
188,493 |
|
|
|
47,018 |
|
|
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