Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a
biotechnology company focused on discovering, developing, and
commercializing novel gene and cell therapies, and vaccines, today
reported first quarter 2024 financial results along with a general
business update.
“We’ve experienced several important clinical and regulatory
milestones since the beginning of 2024 that we believe are leading
the way to a new treatment paradigm for patients with blindness
diseases,” said Dr. Shankar Musunuri, Chairman, Chief Executive
Officer, and Co-Founder of Ocugen. “It’s very encouraging to have
FDA clearance and EMA support for the Phase 3 clinical trial of our
lead modifier gene therapy candidate that offers a potential
one-time treatment for life.”
With FDA clearance to begin the Phase 3 liMeliGhT clinical
trial, OCU400 becomes the first gene therapy to progress to
late-stage trials with a broad retinitis pigmentosa (RP)
indication. Until now, there has been only one marketed product to
treat one of the 100 gene mutations associated with RP. The
gene-agnostic mechanism of action for OCU400 provides hope for a
much larger RP patient population. In the U.S. and Europe combined,
RP affects nearly 300,000 people.
Ocugen expects to begin dosing patients in the Phase 3 liMeliGhT
clinical trial in the second quarter of 2024. The Phase 3 trial
will have a sample size of 150 participants—one arm of 75
participants with the RHO gene mutation and the other arm
with 75 participants that are gene-agnostic. Luminance
Dependent Navigation Assessment (LDNA) is the primary endpoint for
the study and focuses on the proportion of responders, in treated
and untreated groups, achieving an improvement of at least 2 Lux
levels from baseline in the study eyes.
Leveraging a dual-track strategy, the Company plans to expand
the Phase 3 OCU400 clinical trial in the second half of 2024 to
include patients with Leber congenital amaurosis (LCA), contingent
on favorable results from the Phase 1/2 study.
Modifier gene therapy has the potential to treat inherited
retinal diseases as well as multifactorial blindness diseases
affecting millions of patients. Leveraging the nuclear receptor
gene RAR-related orphan receptor A (RORA), OCU410 is designed to
regulate all four pathways involved with dry age-related macular
degeneration (dAMD)—including lipid metabolism, inflammation,
oxidative stress, and membrane attack complex (complement). Ocugen
is developing OCU410 as a one-time gene therapy for the
treatment of geographic atrophy (GA), an advanced stage of dAMD,
affecting 2-3 million people in the U.S. and Europe combined.
OCU410ST is being developed as a one-time gene therapy for the
treatment of Stargardt disease, affecting approximately 100,000
people in the U.S. and Europe combined.
In April, dosing was completed in the second cohort (medium
dose) of the Phase 1/2 ArMaDa clinical trial for OCU410. Dosing in
the first cohort (low dose) of the Phase 1/2 GARDian trial for
OCU410ST was completed earlier in the first quarter and in April
2024, the Data Safety and Monitoring Board approved the
continuation to cohort 2 (medium dose).
“Our efforts in the first quarter of the year evidence the
importance of our gene therapy programs and the need to operate the
business to ensure their success,” said Dr. Musunuri. “We are
opportunistic about Ocugen’s cell therapy and vaccine platforms,
knowing that these technologies have great therapeutic and
financial potential and are pursuing partnerships to support our
entire pipeline.”
Ophthalmic Gene Therapies —First-in-class
- OCU400—Received FDA clearance of IND amendment
to initiate OCU400 Phase 3 liMeliGhT clinical trial in RP. EMA
provided acceptability of the U.S.-based trial for submission of
Marketing Authorization Application (MAA). Currently, the
multi-center Phase 3 clinical trial is in progress.
- OCU410
– Currently in Phase 1/2 stage of clinical development
with active patient enrollment. Dosing is complete in the second
cohort (medium dose) in the dose-escalation phase of the study.
Once the third cohort (high dose) is complete, the Company will
move into the Phase 2 clinical trial—the expansion phase—in the
third quarter of 2024.
-
OCU410ST – Currently in Phase 1/2 stage of
clinical development with active patient enrollment. Dosing is
complete for cohort 1 (low dose). Initiated enrollment in cohort 2
(medium dose) in the dose-escalation phase of the trial.
Regenerative Cell Therapies—First-in-class
- NeoCart® – Completed renovating an
existing facility into a current Good Manufacturing Practice
(“GMP”) facility in accordance with the FDA’s regulations. Intend
to initiate the Phase 3 trial, contingent on adequate availability
of funding.
Vaccines Portfolio—First-in-class
- Mucosal Vaccine Platform – NIAID is
collaborating with Ocugen on clinical development of OCU500.
Planning to submit IND by mid-2024 to initiate Phase 1 clinical
trial.
Biologics
- OCU200—Continue to work with FDA to address
comments to lift the clinical hold.
First Quarter 2024 Financial Results
- The Company’s cash and cash
equivalents totaled $26.4 million as of March 31, 2024,
compared to $39.5 million as of December 31, 2023. The Company
had 257.3 million shares of common stock outstanding as of March
31, 2024.
- Total operating expenses for the three
months ended March 31, 2024 were $13.2 million and included
research and development expenses of $6.8 million and general
and administrative expenses of $6.4 million. This compares to
total operating expenses for the three months ended March 31, 2023
of $18.5 million that included research and development
expenses of $10.2 million and general and administrative
expenses of $8.3 million.
- Ocugen reported a $0.05 net loss per
common share for the three months ended March 31, 2024 compared to
a $0.08 net loss per common share for the three months ended March
31, 2023.
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:
8699924Webcast: 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 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, including, but not limited to, strategy,
business plans and objectives for Ocugen’s clinical programs, plans
and timelines for the preclinical and clinical development of
Ocugen’s 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; Ocugen’s financial condition, statements
regarding qualitative assessments of available data, potential
benefits, expectations for ongoing clinical trials, anticipated
regulatory filings and anticipated development timelines, 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 are
subject to numerous important factors, risks, and uncertainties
that may cause actual events or results to differ materially from
our current expectations, including, but not limited to, the risks
that preliminary, interim and top-line clinical trial results may
not be indicative of, and may differ from, final clinical data;
that unfavorable new clinical trial data may emerge in ongoing
clinical trials or through further analyses of existing clinical
trial data; that earlier non-clinical and clinical data and testing
of may not be predictive of the results or success of later
clinical trials; and that that clinical trial data are subject to
differing interpretations and assessments, including by regulatory
authorities. These and other risks and uncertainties are more fully
described in our annual and 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. Any forward-looking statements
that we make in this press release speak only as of the date of
this press release. 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) |
|
|
March 31, 2024 |
|
December 31, 2023 |
Assets |
|
|
|
Current assets |
|
|
|
Cash and cash equivalents |
$ |
26,375 |
|
|
$ |
39,462 |
|
Prepaid expenses and other current assets |
|
3,623 |
|
|
|
3,509 |
|
Total current assets |
|
29,998 |
|
|
|
42,971 |
|
Property and equipment, net |
|
17,654 |
|
|
|
17,290 |
|
Other assets |
|
4,142 |
|
|
|
4,286 |
|
Total
assets |
$ |
51,794 |
|
|
$ |
64,547 |
|
Liabilities and
stockholders' equity |
|
|
|
Current liabilities |
|
|
|
Accounts payable |
$ |
1,731 |
|
|
$ |
3,172 |
|
Accrued expenses and other current liabilities |
|
12,434 |
|
|
|
13,343 |
|
Operating lease obligations |
|
589 |
|
|
|
574 |
|
Current portion of long term debt |
|
1,296 |
|
|
|
— |
|
Total current liabilities |
|
16,050 |
|
|
|
17,089 |
|
Non-current liabilities |
|
|
|
Operating lease obligations, less current portion |
|
3,414 |
|
|
|
3,567 |
|
Long term debt, net |
|
1,533 |
|
|
|
2,800 |
|
Other non-current liabilities |
|
536 |
|
|
|
527 |
|
Total liabilities |
|
21,533 |
|
|
|
23,983 |
|
Stockholders' equity |
|
|
|
Convertible preferred stock |
|
1 |
|
|
|
1 |
|
Common stock |
|
2,575 |
|
|
|
2,567 |
|
Treasury stock |
|
(48 |
) |
|
|
(48 |
) |
Additional paid-in capital |
|
325,799 |
|
|
|
324,191 |
|
Accumulated other comprehensive income |
|
25 |
|
|
|
20 |
|
Accumulated deficit |
|
(298,091 |
) |
|
|
(286,167 |
) |
Total stockholders' equity |
|
30,261 |
|
|
|
40,564 |
|
Total liabilities and
stockholders' equity |
$ |
51,794 |
|
|
$ |
64,547 |
|
|
OCUGEN, INC. |
CONSOLIDATED STATEMENTS OF OPERATIONS |
(in thousands, except share and per share
amounts) |
(Unaudited) |
|
|
Three months ended March 31, |
|
|
2024 |
|
|
|
2023 |
|
Collaborative arrangement
revenue |
$ |
1,014 |
|
|
$ |
443 |
|
Total revenue |
|
1,014 |
|
|
|
443 |
|
Operating expenses |
|
|
|
Research and development |
|
6,826 |
|
|
|
10,172 |
|
General and administrative |
|
6,404 |
|
|
|
8,306 |
|
Total operating expenses |
|
13,230 |
|
|
|
18,478 |
|
Loss from operations |
|
(12,216 |
) |
|
|
(18,035 |
) |
Other income (expense),
net |
|
292 |
|
|
|
709 |
|
Net loss |
$ |
(11,924 |
) |
|
$ |
(17,326 |
) |
|
|
|
|
Shares used in calculating net
loss per common share — basic and diluted |
|
257,232,636 |
|
|
|
225,523,627 |
|
Net loss per share of common
stock — basic and diluted |
$ |
(0.05 |
) |
|
$ |
(0.08 |
) |
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