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Few stocks have delivered such stunning gains in 2021 as Ocugen (NASDAQ:OCGN). The stock has more than quintupled in value so far this year.

Ocugen reported its fourth-quarter results before the market opened on Thursday. The biotech stock jumped more than 3% in early trading. Here are the highlights from the company’s Q4 update.

By the numbers

In the fourth quarter of 2019, Ocugen reported no revenue at all. However, that changed with the company’s Q4 2020 results. Ocugen reported collaboration revenue of $42,620.

The company reported a fourth-quarter net loss of $21.8 million, or $0.31 per share, based on generally accepted accounting principles (GAAP). In the year-ago period, Ocugen had reported a net loss of $20.2 million, or $1.46 per share. The analysts’ consensus estimate was a net loss of $0.02 per share.

Ocugen ended the fourth quarter with cash, cash equivalents and restricted cash of $24 million. This was an increase from the company’s cash position of US$7.4 million as at 31 December 2019.

Behind the numbers

The only number in Ocugen’s Q2 results that really mattered was its cash position. And even that number is now irrelevant, as the company received an additional $4.8 million in net proceeds from an IPO and $21.2 million from a registered direct offering in Q1 2021.

So what was important about Ocugen’s Q2 update? There were two things investors were interested in.

First, Ocugen hopes to commercialise its COVID-19 vaccine Covaxin in the US with its partner Bharat Biotech. Bharat recently published late-stage development results showing 81% efficacy of the vaccine. Ocugen receives 45% of the profits from sales of Covaxin in the US.

The company said it has made “steady progress” in developing a pathway to obtain Emergency Use Authorisation (EUA) for Covaxin in the US. Ocugen continues to talk with US regulatory authorities about this pathway to EUA.

Second, Ocugen plans to move its gene therapy candidate OCU400 for the treatment of retinal diseases into clinical trials in the second half of this year. The company also intends to apply to the US Food and Drug Administration (FDA) for approval to begin two phase 1/2 clinical trials with OCU400 in other indications later this year.

Looking ahead

The most important thing for investors to look forward to at Ocugen is the possibility of the company reaching an agreement with the FDA on a pathway to an EUA for Covaxin. Ocugen would like to file an EUA application based on the results of the late-stage Bharat trial conducted in India. However, it remains to be seen whether the FDA will allow this.

If not, Ocugen and Bharat will probably have to conduct a trial of Covaxin in the US: Many Americans have already received other COVID-19 vaccines that have already received the EEA. That could make recruiting participants difficult.

Source: (fool.com)