Ocugen Provides Business Update with First Quarter 2023 Financial Results
05 Maio 2023 - 8:00AM
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 first quarter 2023 financial results along
with a general business update.
“I am excited about our pipeline achievements to date —
especially those for our modifier gene therapy platform,” said Dr.
Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder
of Ocugen. “The preliminary positive efficacy and safety results
from our Phase 1/2 trial of OCU400 support the potential for this
first-in-class therapeutic approach to be a viable gene-agnostic
treatment for RP and LCA patients. Based on proof-of-concept data,
we are getting ready to introduce two more programs with the
modifier concept into the clinic —including OCU410 for dry
age-related macular degeneration.”
OCU410ST recently received broad ODD from the FDA for the
treatment of ABCA4-associated retinopathies including Stargardt,
RP19, and CORD3 diseases. This designation acknowledges the
potential for OCU410ST to fulfill a significant unmet medical need
and represents a noteworthy milestone in our effort to develop
innovative treatments for inherited retinal diseases.
Ocugen remains dedicated to our potentially first-in-class
ophthalmic programs targeting blindness diseases and vaccines to
support public health. Since the beginning of the year, the Company
has been leading advocacy efforts and pursuing government funding
to potentially bring its inhaled vaccines for COVID-19 and flu to
patients and healthcare professionals searching for next generation
options. Given the FDA’s recent cancellation of emergency use
authorizations issued to monovalent vaccines, Ocugen will now focus
its efforts solely on the development of the inhaled mucosal
vaccine platform, starting with quadrivalent flu and bivalent
COVID-19.
“We will continue to deliver on our corporate goals and
scientific programs throughout 2023 and look forward to providing
updates across our comprehensive portfolio in the coming months,”
concluded Dr. Musunuri.
Ophthalmic Gene Therapies
-
OCU400 – Preliminary safety and efficacy results
among RP patients treated in the first two cohorts of the Phase 1/2
trial indicate positive trend in multi-luminance mobility testing
and best-corrected visual acuity scores for OCU400 treated eyes.
Received FDA approval to enroll pediatric patients in the ongoing
Phase 1/2 trial; dosing to be initiated in the second quarter of
2023. Phase 3 adult trial to be initiated near the end of
2023.
-
OCU410 – Ocugen intends to submit an
Investigational New Drug (“IND”) application for OCU410 in the
second quarter of 2023 to initiate a Phase 1/2 trial.
-
OCU410ST – FDA granted ODD to OCU410ST for the
treatment of ABCA4-associated retinopathies including Stargardt,
RP19, and CRD3 diseases. Ocugen intends to submit an IND
application for OCU410ST in the second quarter of 2023 to initiate
a Phase 1/2 trial.
Ophthalmic Biologic Product
- OCU200 –
Submitted an IND application to the FDA in February 2023 to
initiate a Phase 1 trial targeting diabetic macular edema. In
April, the IND was placed on clinical hold by the FDA as part of
its request for additional information related to chemistry,
manufacturing, and controls prior to initiating the Phase 1 trial.
The company plans to respond to the FDA promptly to get FDA
clearance to initiate the Phase 1 trial.
Regenerative Cell Therapies
-
NeoCart® – Renovations
continue on cGMP manufacturing facility for NeoCart, with
completion planned for the fourth quarter of 2023.
Vaccines Portfolio
-
OCU500/OCU510/OCU520 – Intend to submit an IND
application to the FDA in late 2023/early 2024. Continuing to work
with government agencies to obtain government funding.
-
COVAXIN™ – Ocugen has concluded that the
development of COVAXIN in North America is not commercially viable
as a result of the FDA’s recent decision around monovalent
vaccines.
First Quarter 2023 Financial Results
- The Company’s cash, cash
equivalents, and investments totaled $76.7 million as of
March 31, 2023 compared to $90.9 million as of
December 31, 2022. The Company estimates that its current
cash, cash equivalents, and investments will enable it to fund its
operations into the first quarter of 2024. The Company had 226.4
million shares of common stock outstanding as of March 31,
2023.
- Total operating expenses for the
three months ended March 31, 2023 were $17.8 million and
included research and development expenses of $9.6 million and
general and administrative expenses of $8.2 million. This compares
to total operating expenses for the three months ended
March 31, 2022 of $18.0 million that included research and
development expenses of $7.9 million and general and administrative
expenses of $10.1 million.
- Ocugen reported a $0.07 net loss per
common share for the three months ended March 31, 2023
compared to a $0.09 net loss per common share for the three months
ended March 31, 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: 4613996Webcast:
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 Twitter 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 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. 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
(Tables to follow)OCUGEN,
INC.
CONSOLIDATED
BALANCE SHEETS(in
thousands)(Unaudited) |
|
|
|
March 31, 2023 |
|
|
December 31, 2022 |
Assets |
|
|
|
|
|
Current assets |
|
|
|
|
|
Cash and cash equivalents |
$ |
68,259 |
|
$ |
77,563 |
Marketable securities |
|
8,462 |
|
|
13,371 |
Prepaid expenses and other current assets |
|
7,680 |
|
|
7,558 |
Total current assets |
|
84,401 |
|
|
98,492 |
Property and equipment, net |
|
7,952 |
|
|
6,053 |
Other assets |
|
3,946 |
|
|
4,087 |
Total
assets |
$ |
96,299 |
|
$ |
108,632 |
Liabilities and
stockholders' equity |
|
|
|
|
|
Current liabilities |
|
|
|
|
|
Accounts payable |
$ |
8,092 |
|
$ |
8,062 |
Accrued expenses and other current liabilities |
|
5,823 |
|
|
9,900 |
Operating lease obligations |
|
512 |
|
|
498 |
Current portion of long term debt |
|
1,256 |
|
|
— |
Total current liabilities |
|
15,683 |
|
|
18,460 |
Non-current liabilities |
|
|
|
|
|
Operating lease obligations, less current portion |
|
3,449 |
|
|
3,587 |
Long term debt, net |
|
1,058 |
|
|
2,289 |
Other non-current liabilities |
|
309 |
|
|
244 |
Total liabilities |
|
20,499 |
|
|
24,580 |
Stockholders' equity |
|
|
|
|
|
Convertible preferred stock |
|
1 |
|
|
1 |
Common stock |
|
2,265 |
|
|
2,217 |
Treasury stock |
|
(48) |
|
|
(48) |
Additional paid-in capital |
|
303,073 |
|
|
294,874 |
Accumulated other comprehensive income |
|
25 |
|
|
26 |
Accumulated deficit |
|
(229,516) |
|
|
(213,018) |
Total stockholders' equity |
|
75,800 |
|
|
84,052 |
Total liabilities and
stockholders' equity |
$ |
96,299 |
|
$ |
108,632 |
OCUGEN, INC.CONSOLIDATED STATEMENTS OF
OPERATIONS(in thousands, except share and per
share amounts)(Unaudited) |
|
|
Three months ended March 31, |
|
|
2023 |
|
|
2022 |
Operating expenses |
|
|
|
|
|
Research and development |
$ |
9,558 |
|
$ |
7,915 |
General and administrative |
|
8,193 |
|
|
10,119 |
Total operating expenses |
|
17,751 |
|
|
18,034 |
Loss from operations |
|
(17,751) |
|
|
(18,034) |
Other income (expense),
net |
|
1,253 |
|
|
15 |
Net loss |
$ |
(16,498) |
|
$ |
(18,019) |
|
|
|
|
|
|
Shares used in calculating net
loss per common share — basic and diluted |
|
225,523,627 |
|
|
205,693,498 |
Net loss per common share —
basic and diluted |
$ |
(0.07) |
|
$ |
(0.09) |
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