Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a
biotechnology company focused on discovering, developing, and
commercializing novel gene and cell therapies, biologics, and
vaccines, today reported third quarter 2023 financial results along
with a general business update.
“Ocugen has made significant pipeline progress in the third
quarter,” said Dr. Shankar Musunuri, Chairman, Chief Executive
Officer, and Co-Founder of Ocugen. “In particular, based on the
OCU400 data presented in September, I am as enthusiastic as ever
regarding the potential for our modifier gene therapy approach to
make an important difference in the lives of people living with
blindness diseases. OCU400—our lead candidate—has the potential to
address multiple genetic mutations with a single product compared
to traditional gene therapies that target one gene at a time.”
This clinical efficacy update provided in September 2023
included data for 12 subjects who have completed a minimum of 6
months follow up. 83%, 83%, and 75% of subjects demonstrated
stabilization or improvements in OCU400 treated eyes on BCVA, LLVA,
and MLMT scores, respectively from baseline. 86% of subjects with
the RHO gene mutation experienced either stabilization or increase
in MLMT scores from baseline, including a subset of 29% that
demonstrated a three Lux luminance level improvement. Preservation
of remaining vision, slowing disease progression, or improving the
vision can significantly impact patients’ quality of life.
“The improvements in BCVA, LLVA and MLMT in RHO patients—a
disease affecting more than 10,000 people in the U.S.
alone—supports the gene-agnostic mechanism of action for OCU400,”
said Dr. Musunuri.
In October 2023, OCU500, was selected by the NIAID Project
NextGen for inclusion in clinical trials. OCU500 will be tested via
two different mucosal routes, inhalation into the lungs and as a
nasal spray. Currently used injected vaccines, including mRNA
vaccines, are not effective in preventing infection and spread
although effective against severe infection. Generating mucosal
immunity in nasal and respiratory airways could help block the
infection at its origin, thus limiting spread.
“NIAID support for our mucosal vaccine platform is the result of
many months of hard work and dedicated effort by our Ocugen team
and is a first step in potentially expanding the platform to flu
and other respiratory viral diseases and infections,” said Dr.
Musunuri. “Additionally, this funding makes it possible to focus
the majority of Ocugen’s R&D and clinical resources on our
first-in-class gene and cell therapies.” As Ocugen prepares to
start Phase 3 for OCU400, begin dosing patients for OCU410 and
OCU410ST, and initiate the Phase 1 trial for OCU500 in
collaboration with NIAID, the company is making meaningful progress
toward its long-term strategy and delivering on each of its
scientific platforms in the near-term.
Ophthalmic Gene Therapies—First-in-class
-
OCU400 – Completed dosing adult RP patients in the
dose-escalation and dose-expansion portions of the trial; completed
dosing three LCA patients including a pediatric patient. Phase 3
clinical trial for the treatment of RP to be initiated in early
2024 following FDA concurrence on study design. Subsequently, the
Company is expecting to expand the OCU400 Phase 3 clinical trial
for LCA patients in the second half of 2024 based on Phase 1/2
study results in LCA patients and alignment with the FDA.
- OCU410 and
OCU410ST – IND applications to initiate Phase 1/2 trials
for both OCU410 and OCU410ST were cleared by the FDA and the
Company intends to dose patients in Phase 1/2 trials by the end of
2023.
Ophthalmic Biologic Product
- OCU200 – Continuing to work on the Company’s
response to the FDA regarding the IND application and expect to
initiate the Phase 1 clinical trial in the first half of 2024,
contingent on the lift of the FDA hold and adequate availability of
funding.
Regenerative Cell Therapies—First-in-class
- NeoCart® – Ocugen’s
autologous regenerative cell therapy (using patients’ own cartilage
cells) remains on track to begin its Phase 3 clinical trial in the
second half of 2024. A cGMP facility for manufacturing NeoCart is
expected to be completed at the end of 2023 and qualification is
expected in the first half of 2024.
Vaccines Portfolio—First-in-class
- Mucosal
Vaccine Platform – The Company is collaborating with NIAID
to initiate clinical trials of OCU500 in early 2024.
Third Quarter 2023 Financial Results
- The Company’s cash, cash equivalents,
and investments totaled $53.5 million as of September 30,
2023, compared to $90.9 million as of December 31, 2022.
The Company had 256.5 million shares of common stock
outstanding as of September 30, 2023.
- Total operating expenses for the three
months ended September 30, 2023 were $15.4 million and
included research and development expenses of $6.3 million and
general and administrative expenses of $9.1 million. This
compares to total operating expenses for the three months ended
September 30, 2022 of $23.1 million that included research and
development expenses of $15.6 million and general and
administrative expenses of $7.5 million.
- Ocugen reported a $0.06 net loss per
common share for the three months ended September 30, 2023 compared
to a $0.10 net loss per common share for the three months ended
September 30, 2022.
Conference Call and Webcast Details
Ocugen has scheduled a conference call and webcast for 8:30 a.m.
ET today to discuss the financial results and recent business
highlights. Ocugen’s senior management team will host the call,
which will be open to all listeners. There will also be a
question-and-answer session following the prepared remarks.
Attendees are invited to participate on the call or webcast
using the following details:
Dial-in Numbers: (800) 715-9871 for U.S.
callers and (646) 307-1963 for international
callersConference ID:
1787631Webcast: Available on
the events section of the Ocugen investor site
A replay of the call and archived webcast will be available for
approximately 45 days following the event on the
Ocugen investor site.
About Ocugen, Inc.Ocugen, Inc. is a
biotechnology company focused on discovering, developing, and
commercializing novel gene and cell therapies, biologics, and
vaccines that improve health and offer hope for patients across the
globe. We are making an impact on patient’s lives through
courageous innovation—forging new scientific paths that harness our
unique intellectual and human capital. Our breakthrough modifier
gene therapy platform has the potential to treat multiple retinal
diseases with a single product, and we are advancing research in
infectious diseases to support public health and orthopedic
diseases to address unmet medical needs. Discover more
at www.ocugen.com and follow us
on X and LinkedIn.
Cautionary Note on Forward-Looking
StatementsThis press release contains forward-looking
statements within the meaning of The Private Securities Litigation
Reform Act of 1995, which are subject to risks and uncertainties.
We may, in some cases, use terms such as “predicts,” “believes,”
“potential,” “proposed,” “continue,” “estimates,” “anticipates,”
“expects,” “plans,” “intends,” “may,” “could,” “might,” “will,”
“should,” or other words that convey uncertainty of future events
or outcomes to identify these forward-looking statements. Such
statements include, but are not limited to, statements regarding
the Company’s clinical development activities and related
anticipated timelines; strategy, business plans and objectives for
its clinical stage programs; plans and timelines for the
preclinical and clinical development of its product candidates,
including the therapeutic potential, clinical benefits and safety
thereof; expectations regarding timing, success and data
announcements of current ongoing preclinical and clinical trials;
the ability to initiate new clinical programs; and Ocugen’s
financial condition. Such statements are subject to numerous
important factors, risks, and uncertainties that may cause actual
events or results to differ materially from our current
expectations. These and other risks and uncertainties are more
fully described in our periodic filings with the Securities and
Exchange Commission (SEC), including the risk factors described in
the section entitled “Risk Factors” in the quarterly and annual
reports that we file with the SEC, as well as discussions of
potential risks, uncertainties, and other important factors in
Ocugen’s subsequent filings with the SEC. Any forward-looking
statements that we make in this press release speak only as of the
date of this press release and should not be relied upon as
representing its views as of any subsequent date. Except as
required by law, we assume no obligation to update forward-looking
statements contained in this press release whether as a result of
new information, future events, or otherwise, after the date of
this press release.
Contact:Tiffany HamiltonHead of
CommunicationsIR@ocugen.com
OCUGEN, INC.CONSOLIDATED BALANCE
SHEETS(in
thousands)(Unaudited) |
|
September 30, 2023 |
|
December 31, 2022 |
Assets |
|
|
|
Current assets |
|
|
|
Cash and cash equivalents |
$ |
53,477 |
|
|
$ |
77,563 |
|
Marketable securities |
|
— |
|
|
|
13,371 |
|
Prepaid expenses and other current assets |
|
3,081 |
|
|
|
7,558 |
|
Total current assets |
|
56,558 |
|
|
|
98,492 |
|
Property and equipment, net |
|
14,469 |
|
|
|
6,053 |
|
Other assets |
|
3,660 |
|
|
|
4,087 |
|
Total
assets |
$ |
74,687 |
|
|
$ |
108,632 |
|
Liabilities and stockholders' equity |
|
|
|
Current liabilities |
|
|
|
Accounts payable |
$ |
2,921 |
|
|
$ |
8,062 |
|
Accrued expenses and other current liabilities |
|
6,399 |
|
|
|
9,900 |
|
Operating lease obligations |
|
540 |
|
|
|
498 |
|
Current portion of long term debt |
|
1,276 |
|
|
|
— |
|
Total current liabilities |
|
11,136 |
|
|
|
18,460 |
|
Non-current liabilities |
|
|
|
Operating lease obligations, less current portion |
|
3,164 |
|
|
|
3,587 |
|
Long term debt, net |
|
1,495 |
|
|
|
2,289 |
|
Other non-current liabilities |
|
497 |
|
|
|
244 |
|
Total
liabilities |
|
16,292 |
|
|
|
24,580 |
|
Stockholders' equity |
|
|
|
Convertible preferred stock |
|
1 |
|
|
|
1 |
|
Common stock |
|
2,566 |
|
|
|
2,217 |
|
Treasury stock |
|
(48 |
) |
|
|
(48 |
) |
Additional paid-in capital |
|
322,452 |
|
|
|
294,874 |
|
Accumulated other comprehensive income |
|
27 |
|
|
|
26 |
|
Accumulated deficit |
|
(266,603 |
) |
|
|
(213,018 |
) |
Total
stockholders' equity |
|
58,395 |
|
|
|
84,052 |
|
Total liabilities and stockholders' equity |
$ |
74,687 |
|
|
$ |
108,632 |
|
|
|
|
|
|
|
|
|
OCUGEN, INC.CONSOLIDATED STATEMENTS OF
OPERATIONS(in thousands, except share and per
share amounts)(Unaudited) |
|
Three months ended September 30, |
|
Nine months ended September 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Operating expenses |
|
|
|
|
|
|
|
Research and development |
$ |
6,342 |
|
|
$ |
15,622 |
|
|
$ |
30,069 |
|
|
$ |
32,544 |
|
General and administrative |
|
9,082 |
|
|
|
7,497 |
|
|
|
26,839 |
|
|
|
28,174 |
|
Total operating expenses |
|
15,424 |
|
|
|
23,119 |
|
|
|
56,908 |
|
|
|
60,718 |
|
Loss from operations |
|
(15,424 |
) |
|
|
(23,119 |
) |
|
|
(56,908 |
) |
|
|
(60,718 |
) |
Other income (expense),
net |
|
1,262 |
|
|
|
1,197 |
|
|
|
3,323 |
|
|
|
1,306 |
|
Net loss |
$ |
(14,162 |
) |
|
$ |
(21,922 |
) |
|
$ |
(53,585 |
) |
|
$ |
(59,412 |
) |
|
|
|
|
|
|
|
|
Shares used in calculating net
loss per common share — basic and diluted |
|
256,492,558 |
|
|
|
216,591,011 |
|
|
|
240,222,667 |
|
|
|
212,755,746 |
|
Net loss per share of common
stock — basic and diluted |
$ |
(0.06 |
) |
|
$ |
(0.10 |
) |
|
$ |
(0.22 |
) |
|
$ |
(0.28 |
) |
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