Biopharma to Request U.S. Emergency Use Authorization for COVID-19 Vaccine in April

Source: Streetwise Reports   03/24/2021

Catalysts expected in 2021-2022 regarding Ocugen’s pipeline therapeutics are discussed in a ROTH Capital Partners report.

In a March 19 research note, ROTH Capital Partners analyst Zegbeh Jallah reported the upcoming catalysts of Ocugen Inc.’s (OCGN:NASDAQ) COVID-19 vaccine and its gene modifier therapeutics, as discussed in the company’s recent Q4/20 update call.

“Ocugen is making great strides on both its vaccine and other pipeline efforts,” she stated.

Jallah reviewed the major events, related to Ocugen’s clinical programs, expected this year and next.

Next month, in April 2021, the biopharma expects to apply to the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA) in the U.S. for COVAXIN, its COVID-19 vaccine. Ocugen will file after data become available in early April from the Phase 3 study’s second interim analysis.

“The updated results as well as controls established at central review sites and plans for continued monitoring of clinical trials and COVAXIN-treated patients will all be important for determining if an EUA will indeed be granted,” commented Jallah.

The analyst noted that Ocugen, to increase the chances of obtaining EUA, plans to raise capital to fund some required EUA steps, and it likely would do so via stock sales or a stock agreement. The company had $46.6 million in cash and cash equivalents as of Feb. 28, 2021.

Positives about COVAXIN that may increase its chances of approval include earlier Phase 3 trial data showing it is 81% efficacious and safe in patients aged 18 and older. Also, the vaccine was granted an EUA in India.

Further, COVAXIN has some differentiating advantages, Jallah indicated. One is that it has been shown to be effective against virus variants originating in the United Kingdom, “at a rate we would expect to be better than current EUA-granted COVID vaccines.”

Two, COVAXIN could potentially be used in younger patients and in immunocompromised patients. Along those lines, Ocugen plans to conduct a study in these populations.

Three, COVAXIN does not require cool temperatures for transport or storage. Rather, it remains stable at room temperature for up to three months. Also, it can be stored in constant temperature refrigerators for up to two years and, thus, stockpiled.

Should the FDA grant Ocugen an EUA for COVAXIN, the company plans to provide about 100 million doses this year, manufactured by vaccines specialist Bharat Biotech.

Other upcoming catalysts for Ocugen are from its clinical gene modifier program, which Jallah discussed.

“We are excited about the ongoing developments of the in-house pipeline, as we believe there is great potential for this platform that should garner large pharma interest, noting Novartis’ acquisition of Vedere Bio for $280 million,” she wrote.

By year-end 2021, Ocugen expects to file an investigational new drug (IND) application for OCU400, a therapeutic for multiple gene mutations related to inherited retinal disease. Should the FDA grant OCU400 IND status, the biopharma plans to conduct two parallel Phase 1/2 studies on patients with this disease and with Nr2e3 and Rho mutations.

Next year, Jallah relayed, the biopharma intends to start clinical trials on OCU200, a multimodal biologic for wet age-related macular degeneration (AMD) and diabetic macular edema/diabetic retinopathy, together a substantial market opportunity.

Additionally, Ocugen aims to move OCU410 into the clinic in H1/22, for dry AMD, a bilateral retinal degenerative disorder also presenting a huge market opportunity. The next step for OCU410 is commencing toxicology studies, which the company plans to do in H1/21 but would like to have a pre-IND meeting with the FDA beforehand.

ROTH has a Buy rating and a $10 per share target price on Ocugen, the stock of which is currently priced at about $7.84 per share.

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Disclosures from ROTH Capital Partners, Ocugen Inc., Company Note, March 19, 2021

Regulation Analyst Certification (“Reg AC”): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.

ROTH makes a market in shares of Ocugen, Inc. and as such, buys and sells from customers on a principal basis.
Shares of Ocugen, Inc. may be subject to the Securities and Exchange Commission’s Penny Stock Rules, which may set forth sales practice requirements for certain low-priced securities.

ROTH Capital Partners, LLC expects to receive or intends to seek compensation for investment banking or other business relationships with the covered companies mentioned in this report in the next three months.