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Ocugen Provides Business Update and Third Quarter 2020 Financial Results

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·6 min read
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First Gene Therapy Candidate OCU400 On Track to Enter the Clinic in 2021

MALVERN, Pa., Nov. 06, 2020 (GLOBE NEWSWIRE) -- Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing and commercializing transformative therapies to cure blindness diseases, today reported third quarter 2020 financial results along with a general business update.

“I am proud of the advancements we have made this quarter in developing our modifier gene therapy and novel biologic product candidates. We remain on-track to achieve multiple near and mid-term milestones with a plan to initiate four Phase 1/2a trials during 2021 and 2022. Additionally, I am pleased that we have raised approximately $28 million of gross proceeds in 2020, which have extended our cash runway for continued development of our product candidates,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer and Co-Founder of Ocugen.

Business Highlights:

  • Steady Progress Towards Starting OCU400 Clinical Trials in 2021 – Ocugen has received materials for its Good Laboratory Practice (“GLP”) toxicology study from its manufacturing partner, CanSino Biologics Inc. Ocugen has commenced the detailed design of its two parallel Phase 1/2a trials and is on target to commence them in 2021.

  • Manufacturing Contract for OCU200 – In October 2020, Ocugen entered into an agreement with Kemwell Biopharma Pvt. Ltd (“Kemwell”) to manufacture Ocugen’s biologic product candidate, OCU200. Kemwell offers proven expertise in supporting companies with process development and clinical and commercial manufacturing of biologicals. The agreement with Kemwell is a fundamental step for OCU200 to enter the clinic in the first half of 2022.

  • Full Repayment of Unsecured Notes – From July through October 2020, Ocugen made aggregate prepayments of $4.5 million on the unsecured notes associated with the April 2020 amendment and exchange of its Series A Warrants. Following the October 2020 prepayments, the unsecured notes have been repaid in full and are no longer outstanding.

  • Capital Raised – In the third quarter, Ocugen sold an aggregate of 27.0 million shares of common stock in an at-the-market offering commenced in August 2020, generating net proceeds of $10.1 million and increasing its cash runway into the third quarter of 2021.

Third Quarter 2020 Financial Results:

  • Ocugen’s cash, cash equivalents, and restricted cash totaled $19.3 million as of September 30, 2020, compared to $7.6 million as of December 31, 2019. The Company had 162.0 million shares of common stock outstanding at September 30, 2020.

  • Research and development expenses for the three months ended September 30, 2020 were $1.5 million compared to $1.3 million for the three months ended September 30, 2019. General and administrative expenses for the three months ended September 30, 2020 were $1.7 million compared to $1.4 million for the three months ended September 30, 2019. Ocugen reported a $0.07 loss per share for the three months ended September 30, 2020 compared to a $3.55 loss per share for the three months ended September 30, 2019.

About Ocugen, Inc.

Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing transformative therapies to cure blindness diseases. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. For more information, please visit www.ocugen.com.

Cautionary Note on Forward-Looking Statements

This 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 (the “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.

Corporate Contact:
Ocugen, Inc.
Sanjay Subramanian
Chief Financial Officer
IR@Ocugen.com

Media Contact:
LaVoieHealthScience
Katie Gallagher
kgallagher@lavoiehealthscience.com
+1 617-792-3937

(tables to follow)


OCUGEN, INC.
CONSOLIDATED BALANCE SHEETS
(UNAUDITED)

September 30,
2020

December 31,
2019

Assets

Current assets

Cash and cash equivalents

$

19,105,830

$

7,444,052

Prepaid expenses and other current assets

652,893

1,322,167

Asset held for sale

7,000,000

Total current assets

19,758,723

15,766,219

Property and equipment, net

214,100

222,464

Restricted cash

151,196

151,016

Other assets

415,555

667,747

Total assets

$

20,539,574

$

16,807,446

Liabilities and stockholders’ equity

Current liabilities

Accounts payable

$

222,340

$

1,895,613

Accrued expenses

2,333,733

2,270,045

Short-term debt, net

1,210,645

Operating lease obligation

164,808

172,310

Other current liabilities

199,261

205,991

Total current liabilities

4,130,787

4,543,959

Non-current liabilities

Operating lease obligation, less current portion

42,746

163,198

Long term debt, net

1,944,396

1,072,123

Other non-current liabilities

9,755

Total liabilities

6,117,929

5,789,035

Stockholders’ equity

Common stock

1,621,480

527,467

Treasury Stock

(47,864

)

(47,864

)

Additional paid-in capital

82,359,494

62,018,632

Accumulated deficit

(69,511,465

)

(51,479,824

)

Total stockholders’ equity

14,421,645

11,018,411

Total liabilities and stockholders’ equity

$

20,539,574

$

16,807,446


OCUGEN, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)

Three months ended September 30,

Nine months ended September 30,

2020

2019

2020

2019

Revenues

Collaboration revenue

$

$

$

42,620

$

Total revenues

42,620

Operating expenses

Research and development

1,477,382

1,305,461

4,759,569

6,338,530

In-process research and development

7,000,000

7,000,000

General and administrative

1,704,598

1,408,350

5,760,398

3,544,847

Total operating expenses

10,181,980

2,713,811

17,519,967

9,883,377

Loss from operations

(10,181,980

)

(2,713,811

)

(17,477,347

)

(9,883,377

)

Other income (expense)

Change in fair value of derivative liabilities

(18,512,204

)

(19,896,626

)

Loss on debt conversion

(341,136

)

Interest income

42

136

594

1,107

Interest expense

(291,909

)

(796,141

)

(554,801

)

(1,753,172

)

Other income (expense)

(751,261

)

(87

)

(751,493

)

Total other income (expense)

(291,867

)

(20,059,470

)

(554,294

)

(22,741,320

)

Net loss

$

(10,473,847

)

$

(22,773,281

)

$

(18,031,641

)

$

(32,624,697

)

Deemed dividend related to Warrant Exchange

(12,546,340

)

Net loss to common stockholders

$

(10,473,847

)

$

(22,773,281

)

$

(30,577,981

)

$

(32,624,697

)

Shares used in calculating net loss per common share — basic and diluted

141,591,218

6,411,308

92,764,157

5,839,840

Net loss per share of common stock — basic and diluted

$

(0.07

)

$

(3.55

)

$

(0.33

)

$

(5.59

)