Phase 3 IND Clearance Is Good News We’ve Been Waiting For

Progress In Clinical Trials Overshadows FY2023 Filing Delay

Ocugen Clinical Showcase Meeting Details OCU400 and Potential Gene Therapy Breakthroughs

Raising Price Target to $8 Based On Clinical Progress

Robert LeBoyer

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Ocugen, Inc.

Financial Results Were Within Expectations.&nbsp;Ocugen reported 4Q22 and FY2022 Net Loss of $21.9 million or $(0.10) per share, and $81.4&nbsp; million or $(0.38) per share for FY2022. Cash on hand as of December 31 was $90.9 million or $0.41 per share, which management projects will fund operations through 1Q24. On its quarterly conference call, management discussed recent milestones and development programs in gene therapy, cellular therapy, and vaccines.&nbsp;
Ophthalmology Programs Are Advancing.&nbsp; OCU200 is a fusion protein consisting of tumstatin and transferrin to treat DME, diabetic retinopathy, and wet AMD. In late February, Ocugen filed an IND for OCU200 in diabetic macular edema (DME), meeting its 1Q23 timeline. Trial enrollment is expected to begin patient dosing in 2Q23. Ocugen also reiterated its plan to file an IND during 2Q23 for OCU410 in dry AMD and OCU410ST in Stargardt disease.
OCU400 completed enrollment in its Phase 1/2 dose escalation phase for its retinitis pigmentosa (RP) cohort.&nbsp; After review by the independent Data Safety and Monitoring Board, the highest dose was selected to move forward to the next trials.&nbsp; Enrollment continues in the Leber congenital amaurosis (LCA) patient cohort. Phase 3 trial is expected to start by year-end 2023.
NeoCart &nbsp;NeoCart is a cell therapy for repair of damaged knee cartilage. In December 2022, Ocugen announced that requirements for Phase 3 had been established with the FDA. Ocugen expects to complete renovation of the facilities for cGMP manufacturing by year end and plans to start the trial in 1H24.
Vaccine Programs For COVID-19 and Influenza.&nbsp;In 3Q22, Ocugen licensed the nasally administered vaccine now known as OCU500.&nbsp;The vaccine program has grown into the &#8220;OCU500 Series&#8221;, including vaccines for COVID-19 and influenza. OCU500 is bivalent vaccine for COVID-19 that stimulates mucosal immunity in the nose to prevent both infection and transmission. OCU510 is an internally-developed bivalent influenza vaccine, and OCU520 is a quadravalent combination for both COVID-19 and influenza. Ocugen is conducting preclinical testing to file an IND in 4Q23 for clinical studies.
We see the development of a COVID-19 booster, an influenza vaccine, and the combination as a good strategy.&nbsp;An estimated 170 million doses of influenza vaccines were administered to about 50% of the US population during the 2022-23 influenza season. A single inhaled vaccination against both could meet the expected need for annual COVID-19 boosters and&nbsp;capture a large segment of the population.
Additional COVAXIN Data Expected Mid-2023. &nbsp;Initial data from the Phase 2/3 immunobridging study was released in January 2023, showing sufficient immunogenicity in the current US population.&nbsp; The final data is expected in mid-2023.&nbsp; At this time, the company is in active discussions for non-dilutive funding for the program. 
 
Conclusion.&nbsp; Filing the IND for OCU200 in DME was an important milestone.&nbsp; When the OCU410 IND is filed in 2Q23, Ocugen will have three ophthalmology programs addressing either large populations or orphan diseases. The vaccine programs are also making progress, adding influenza and a focus on a COVID-19 booster.&nbsp; The company has met several milestones that we believe show fundamental improvements.&nbsp; We are reiterating our Outperform rating and $5 price target.

Ocugen, Inc. (OCGN)

FY2022 Reported With Pipeline Updates

Fundamental Analysis:

Rating: Log in to view

Phase 3 IND Clearance Is Good News We’ve Been Waiting For (OCGN)

Progress In Clinical Trials Overshadows FY2023 Filing Delay (OCGN)

Ocugen Clinical Showcase Meeting Details OCU400 and Potential Gene Therapy Breakthroughs (OCGN)

Raising Price Target to $8 Based On Clinical Progress (OCGN)

Inbox Intel from Channelchek.