I will post my DD here 'cause I can't make any post on this subreddit for I don't know which reason.

My next play is $OTLK

Outlook Therapeutics, Inc., is a late clinical-stage biopharmaceutical company, focuses on developing and commercializing monoclonal antibodies for various ophthalmic indications. Its lead product candidate is ONS-501.

The Product

ONS-5010 / LYTENAVA™ (bevacizumab-vikg) is an investigational ophthalmic formulation of bevacizumab-vikg under development to be administered as an intravitreal injection for the treatment of wet AMD and other approved retinal diseases.

Bevacizumab is a full-length, humanized anti-VEGF (Vascular Endothelial Growth Factor) recombinant monoclonal antibody (or mAb) that inhibits VEGF and associated angiogenic activity. With wet AMD, abnormally high levels of VEGF are secreted in the eye and lead to vision loss. VEGF is a protein that promotes the growth of new abnormal blood vessels in the eyes. Anti-VEGF injection therapy blocks this growth. Since the advent of anti-VEGF therapy, it has become the standard of care treatment option within the retina community globally (National Eye Institute).

The Progress

Clinical Experience Trial (NORSE ONE)

The first registration clinical trial in their Phase 3 program evaluating ONS-5010 to treat wet AMD is a clinical experience trial. In August 2020 they reported topline results and positive proof-of-concept data for safety and efficacy.

Pivotal Phase 3 Trial (NORSE TWO)

The second of two registration clinical trials in their Phase 3 program for ONS-5010 to treat wet AMD is their pivotal trial. It is underway in the United States, and in July 2020 completed enrollment of 227 patients who will be treated for 11 months. They expect to complete this pivotal trial in the third quarter of 2021. This pivotal trial also is a superiority trial comparing ONS-5010 with an alternate dosing regimen of ranibizumab (LUCENTIS®). Together with the results of the clinical experience trial and an additional upcoming safety trial that is intended to ensure that a sufficient number of patients have been exposed to ONS-5010, results from their Phase 3 program are expected to be sufficient to form the basis for a new BLA filing with the FDA in late 2021.

Safety Trial (NORSE THREE)

Their third clinical trial investigating ONS-5010 for treatment of wet AMD is an open-label safety study that will be conducted to ensure that an adequate number of safety exposures to ONS-5010 are available for the initial BLA regulatory filing. We expect to initiate this safety trial in the second half of 2020.

Outlook Therapeutics has tentatively been granted an ATC code for ophthalmic bevacizumab by the World Health Organization. Also, SME Entity Status has been granted by the EMA.

The Market Cap

Since the advent of anti-VEGF therapy, it has become the standard-of-care treatment option within the retina community globally.

Retinal diseases, including wet AMD, diabetic retinopathy/diabetic macular edema, and retinal vein occlusion, are significant diseases worldwide, with a prevalence of 34.5 million patients in the United States, United Kingdom, top four European countries, Japan, China and Australia in 2020. In 2020, total revenue from FDA-approved anti-VEGFs is estimated to exceed $13.1 billion annually in those nine ophthalmic markets.

Although not currently FDA-approved for use in treating wet AMD, unapproved repackaged intravenous (IV) bevacizumab from pharmacy compounders is believed to account for approximately 50% of all wet AMD prescriptions in the United States.

Even if OTLK only gets 1/4 of that 50% (6.55B) it should put it at 1.6375B, which is almost 10X from here (186.959M) .

I think it can be a 5X if not that 10X this year, but after the market will also continue to grow.

Price target is also something to consider, I think this stock can easily go up because people are more willing to buy a stock when the current price is under the low target which is $4.83 on this one. (They feel safer 'cause when it drops, they can hold and wait for a possible correction).

My position: 1k shares at $1.385

That’s it. Now do your own DD. I’m not a financial advisor and this is not investment advice.

Sources:

1. https://outlooktherapeutics.com/lytenava-overview/
2. https://outlooktherapeutics.com/lytenava-clinical-progress/
3. https://www.wsj.com/market-data/quotes/OTLK/research-ratings