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Ocugen Provides Organization Update and First Quarter 2022 Financial Outcomes

Byadmin2

May 6, 2022
ti

Teleconference and Webcast Today at 8:30 a.m. ET

    .

  • OCU400 Stage 1/2 scientific trial for groundbreaking modifier gene treatment for the treatment of NR2E3 and RHO-related retinitis pigmentosa is advancing after DSMB evaluation
  • .

  • Ocugen s special area for COVAXIN (BBV152) marketing broadened to consist of all of The United States and Canada
  • .

MALVERN, Pa., Might 06, 2022( WORLD NEWSWIRE)– Ocugen, Inc. ( Ocugen or the Business)( NASDAQ: OCGN), a biotechnology business concentrated on finding, establishing, and advertising unique gene treatments, biologicals, and vaccines, today reported very first quarter 2022 monetary outcomes in addition to a basic service upgrade.

We ve made considerable development this quarter throughout numerous locations and we stay positive in the long-lasting chances and development that our company believe our pipeline will open, stated Dr. Shankar Musunuri, Chairman, Ceo, and Co-Founder of Ocugen. I am really happy with our devoted group for moving our development gene treatment into the center and for their dedication to advancing COVAXIN to eliminate versus COVID-19.

Organization Updates

    .

  • OCU400 Medical Trial The Business attained a crucial turning point in its Stage 1/2 scientific trial for OCU400 of very first client, initially dosage in late March 2022. The Information and Security Tracking Board for the scientific trial examined security information based upon dosing to date and advised that the research study continue with registering the staying research study topics in the present friend at the target dosage level. A 2nd client was dosed in Might 2022.
  • .

  • COVAXIN Rights Expanded to consist of Mexico In April 2022, the Business broadened its rights to establish, make, and advertise COVAXIN to consist of Mexico, where the vaccine is currently licensed for emergency situation usage in grownups and is presently under evaluation by regional regulators for emergency situation pediatric usage. The business is now dealing with advertising the vaccine in Mexico. The Business s special area for COVAXIN now incorporates the whole North American area.
  • .

  • COVAXIN in the United States The Business is actively participated in conversations with the U.S. Fda (the FDA) to resolve its concerns and resume the Business s Stage 2/3 immuno-bridging and widening scientific trial for COVAXIN, OCU-002. In addition, the Business plans to continue dealing with the FDA to settle the extra research studies needed for a Biologics License Application (BLA).
  • .

  • COVAXIN in Canada Discussions with Health Canada concerning COVAXIN are continuous. The Business remains in conversations with Canadian authorities concerning financial backing for the prospective acquisition of a production center in Belleville, Ontario, Canada that would be changed to end up being a production and research study and advancement center to support both the Business s present and future item prospect pipeline.
  • .

  • Organizational Development Almost 20 staff members signed up with Ocugen in the very first quarter to fill essential functions that support functional requirements, consisting of scientific trials and regulative turning points. The variety of staff members now amounts to 79.
  • .

  • Addition to the Board of Directors In March 2022, Marna C. Whittington, Ph.D., previous Ceo of Allianz Global Investors Capital, signed up with the Business s Board of Directors. Dr. Whittington is a distinguished monetary sector leader and her experience and competence will be exceptionally essential to the Business s development technique.
  • .

Very First Quarter 2022 Financial Outcomes

    .

  • The Business s money, money equivalents, and limited money amounted to$ 129.9 million since March 31, 2022, compared to$ 95.1 million since December 31, 2021. The Business had 215.6 million shares of typical stock impressive since March 31, 2022.
  • .

  • Research study and advancement costs for the 3 months ended March 31, 2022 were $7.9 million compared to $2.9 million for the 3 months ended March 31, 2021. General and administrative costs for the 3 months ended March 31, 2022 were $10.1 million compared to $4.2 million for the 3 months ended March 31, 2021. Ocugen reported a $0.09 bottom line per share for the 3 months ended March 31, 2022 compared to a $0.04 bottom line per share for the 3 months ended March 31, 2021.
  • .

Teleconference and Webcast Particulars

Ocugen has actually set up a teleconference and webcast for 8:30 a.m. eastern time today to go over the monetary outcomes and current service updates. Ocugen s senior management group will host the call, which will be open to all listeners. There will likewise be a question-and-answer session following the ready remarks.

The call can be accessed by dialing (844) 873-7330 (U.S.) or (602) 563-8473 (global) and offering the conference ID 6995784. To access a live audio webcast of the call on the Financiers area of the Ocugen site, please click here A replay of the webcast will be archived on Ocugen s site for roughly 45 days following the call.

About Ocugen, Inc.
. Ocugen, Inc. is a biotechnology business concentrated on finding, establishing, and advertising unique gene treatments, biologicals and vaccines that enhance health and deal wish for individuals and worldwide neighborhoods. We are making an effect through bold development, taking science in brand-new instructions in service of clients. Our development modifier gene treatment platform has the prospective to deal with numerous illness with one drug and we are advancing research study in other healing locations to provide brand-new choices for individuals with unmet medical requirements. Discover more at www.ocugen.com and follow us on Twitter and LinkedIn

Cautionary Note on Forward-Looking Statements
. This news release consists of positive declarations within the significance of The Personal Securities Lawsuits Reform Act of 1995, which undergo dangers and unpredictabilities. Ocugen may, in many cases, utilize terms such as forecasts, thinks, prospective, proposed, continue, quotes, expects, anticipates, strategies, plans, may, could, might, will, need to or other words that communicate unpredictability of future occasions or results to determine these positive declarations. Such positive declarations consist of, however are not restricted to, declarations about Ocugen s development ahead of time the evaluation of COVAXIN and its other item prospects with the FDA, and undergo dangers and unpredictabilities that might trigger real outcomes to vary materially from those revealed or indicated by such declarations, consisting of, to name a few things, the unpredictabilities fundamental in research study and advancement, consisting of the capability to satisfy awaited scientific endpoints, capability to prompt register scientific trial individuals, start and/or conclusion dates for scientific trials, regulative submission dates, regulative approval dates and/or launch dates; the threat that Health Canada does decline its New Drug Submission (NDS) for COVAXIN or that Ocugen might not have the ability to sufficiently solve the shortages kept in mind by Health Canada with regard to its NDS, for which Ocugen has actually supplied reactions that are presently under evaluation by Health Canada; the threat that Ocugen might not have the ability to effectively advertise COVAXIN in Mexico for grownups over the age of 18 pursuant to Ocugen s arrangement with Bharat Biotech and the threat that Ocugen does not acquire emergency situation pediatric usage for COVAXIN in Mexico for kids in between 2 and 18 years of age on a prompt basis, if at all; the threat that the FDA does not raise the scientific hang on Ocugen s Stage 2/3 immuno-bridging and widening scientific trial for COVAXIN on a prompt basis, if at all; dangers connected with initial and interim information, consisting of the possibility of undesirable brand-new scientific trial information and more analyses of existing scientific trial information; the threat that the outcomes of in-vitro research studies will not be replicated in human scientific trials; the threat that scientific trial information goes through varying analyses and evaluations, consisting of throughout the peer review/publication procedure, in the clinical neighborhood normally, and by regulative authorities; whether and when information from Bharat Biotech’s scientific trials will be released in clinical journal publications and, if so, when and with what adjustments; whether the information and arise from the preclinical and scientific research studies of COVAXIN, which have actually been performed by Bharat Biotech in India, will be accepted by regulative authorities or otherwise adequate to support Ocugen s submissions for regulative approvals or permissions in the United States, Canada or Mexico; the size, scope, timing and result of any extra scientific trials or research studies that Ocugen might be needed to perform to support regulative approvals or permissions; any extra chemistry, production, and manages details that Ocugen might be needed to send to regulative authorities; whether and when a BLA for COVAXIN will be sent to or authorized by the FDA; the threat that Ocugen might not have the ability to effectively work out and carry out conclusive deal contracts for the acquisition of the making website on appropriate terms, if at all, and the supreme terms and timing for closing of the deals considered consequently; the threat that Ocugen will not have the ability to effectively close the acquisition of the making website; dangers connected with the prepared advancement and refurbishing of the making website, consisting of that the anticipated expenses for such advancement might be higher than presently considered or that the prepared advancement might take longer than anticipated or stop working to be finished on a prompt basis, if at all; and the threat that Ocugen will not have the ability to scale production for such making website to sufficiently support production of its item prospects or the other items that might in the future be made at such making website; whether advancements with regard to the COVID-19 pandemic will impact the regulative path offered for vaccines in the United States, Canada, Mexico or other jurisdictions; market need for COVAXIN in the United States, Canada or Mexico; choices by the regulative authorities affecting labeling, making procedures, security and/or other matters that might impact the schedule or business capacity of COVAXIN in the United States, Canada or Mexico, consisting of advancement of items or treatments by other business. These and other dangers and unpredictabilities are more totally explained in Ocugen s regular filings with the Securities and Exchange Commission (SEC), consisting of the threat elements explained in the area entitled Threat Consider the quarterly and yearly reports that Ocugen files with the SEC. Any positive declarations that Ocugen makes in this news release speak just since the date of this news release. Other than as needed by law, Ocugen presumes no commitment to upgrade positive declarations included in this news release whether as an outcome of brand-new details, future occasions, or otherwise, after the date of this news release.

Ocugen Contact:

Ken Inchausti
. Head, Financier Relations & & Communications
. +1 484 237 3398
. ken.inchausti@ocugen.com

Please send investor-related questions to: IR@ocugen.com

( tables to follow)

OCUGEN, INC.

COMBINED BALANCE SHEETS

( in thousands)

( Unaudited)

.

.

.

.

.

.

.

.

.

.

.

.(* )(* ) .

.

Present possessions

.

.

.

.

Money and money equivalents

.

$

129,771

$

94,958

.

Prepaid costs and other present possessions

.

8,256

7,688

.

Overall present possessions

.

138,027

102,646

.

Home and devices, web

.

1,921

1,164

.

Limited money

.

151

151

.

.

.

.

.

.

.

.

.

.

.

$

.

.

.

.

.

.

.

.

.

.(* )

.

Present liabilities

.

.

Accounts payable

$

.

3,896

$

2,312

.

Accumulated costs

.

3,537

4,325

.

Operating lease commitments

.

254

363

.

Overall present liabilities

.

7,687

7,000

.

Non-current liabilities

.

.

Operating lease commitments,
less present part

.

1,180

.

.

.(* ) .

Long term financial obligation,
web

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.(* )

1

.

Typical stock

2,158

.

1,995

.

Treasury stock

( 48

)

.

( 48

)

.

Extra paid-in capital

278,704

.

(* ) .

.(* )225,537

.

Collected deficit

( 149,686

)

.

(131,667

)

.

Overall shareholders’ equity

131,129

.

95,818

.

Overall liabilities and shareholders’ equity

$

141,727

.

$

105,761

.

OCUGEN, INC.

(in thousands, other than share and per share quantities)

.

.

.

3 months ended March 31,

.

March 31, 2022 December 31, 2021
Possessions .
(* ) . .
. . . . . . . .
. . . . . . . .
. . . . . . . .
. . . . . . . .
. . . . . . . .(* )Other possessions
1,628 1,800 . Overall possessions
141,727 $ 105,761 . Liabilities and shareholders’ equity
.
. . .
. . . .
. . . . . . . .
. . . . . . . .
. . . . . . . .
. . . . . . . .
. . . .
. . .(* ) 1,231 . . .(* )1,731
1,712 . Overall liabilities 10,598
9,943 . Stockholders’ equity
. Convertible favored stock 1
. . . . . . . .
. . . . . . . .
. . . . . . . .
. . . . . . .
. . . . . . . .
. . . . . . . .
. . . . COMBINED DECLARATIONS OF OPERATIONS (Unaudited) .

.

.

.

.

2022

.

2021

.

Operating costs

.

.

Research study and advancement

$

7,915

.

$

2,872

.

General and administrative

10,119

.

4,185

.

Overall business expenses

18,034

.

7,057

.

Loss from operations

(18,034

)

.

(7,057

)

.

Other earnings (expenditure), web

15

.

(20

)

.

Bottom line and detailed loss

$

(18,019

)

.

$

(7,077

)

.

.

.

Shares utilized in determining bottom line per typical share standard and diluted

205,693,498

.

186,298,122

.

Bottom line per share of typical stock standard and diluted

$

(0.09

)

.

$

(0.04

)

.

.

.

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