Shares of coronavirus vaccine developer Ocugen (OCGN 2.98%) are up 6.74% to $8.00 apiece as of 2:30 p.m. EDT. The company provided business updates in its second-quarter earnings release earlier in the day. It has completed the submission of its India-based partner Bharat Biotech's coronavirus vaccine COVAXIN to regulatory authorities in Canada. The vaccine demonstrated 78% efficacy against overall COVID-19. Ocugen does not have any biologics of its own on the market. It holds commercialization rights for COVAXIN in the U.S. and Canada, and is eligible for 45% of profits from commercialization in the two countries.

Young person proudly pointing at their upper arm where a vaccine shot was given.

Image source: Getty Images.

So what 

Ocugen has been trying to sell 100 million doses of COVAXIN in the U.S. since February. However, in June, the U.S. Food and Drug Administration (FDA) recommended Ocugen file for approval in the form of a Biologic License Application (BLA) instead of an Emergency Use Authorization (EUA). The company also anticipates the need to run another phase 3 study to support the vaccine's approval.

Now what

The lack of a timely launch in the U.S. and of rights to ownership of the vaccine itself means Ocugen only has a market cap of $1.48 billion -- relatively tiny compared to the market cap of competitors like Novavax (NVAX -1.89%) and Moderna (MRNA -3.36%). However, investors are hoping that the vaccine could attain success in Canada, not necessarily for use in domestic vaccination campaigns. The Canadian Government bought 100 million doses of coronavirus vaccines and shared them with developing nations back in June. So there's speculation that COVAXIN could receive orders via the government's equitable distribution program. Still, with no product revenue, it's best to be careful about investing in the speculative biotech.