Stocks with DEEEP DD. Yes...even more than what Seeking Alpha often provides
FN Summary: Lead product (Mino-Lok) has QIDP, Fast Track & Priority Review designation with no competition and patent protection until 2036. Phase 2 results had a 100% response rate – Phase 3 now in progress. All-star management has 1) invested side-by-side with the investors, and 2) a long history of biotech product successes.
FN Summary: Lead asset (Adalimumab) is in a fully funded and fully enrolled Phase 2b/3 trial. Outstanding company management and BOD oversight (10 out of 10). Cash position is good with management taking minimal salary. Government grants currently fund almost all of their clinical trials.
FN Summary: Larazotide, for Celiac Disease, is in P3 trials and is 2 years ahead of competition. Also have proprietary NM-002 for Short Bowel Syndrome. Excellent analyst coverage, recent insider buying and good cash reserves until next catalyst (Topline P2 readout of NM-002) in Q4 2021.
FN Summary: Omeros has 2 breakthrough therapy designations for their lead asset (Narsoplimab). Narso is currently awaiting PDUFA for HSCT-TMA, which should occur on Oct 17, 2021. Narso for IgAN (very large market) is currently in a P3 trial, but not expecting results until 2023. Company has a history of taking a long time to complete clinical trials. If PDUFA is granted, company is a prime candidate for a buyout. Good cash until next catalyst.
FN Summary: Lead asset (cytisinicline) for smoking cessation demonstrated excellent Phase-2b results (~55% better than Chantix™) with superior safety profile. The drug (derived from a plant) has been used for decades in Eastern Europe. Drug is in P3 trial with topline readout due Q1 2022. Might need to raise capital in Q4 2021.
FN Summary: Lead asset (CAP-1002) had very good results in a small P2 trial. Drug qualified for RMAT designation. This allows them to possibly file for a BLA using their P2 results. If they can’t (definitely a possibility), then they must do a P3 trial. Good cash position, but will not last if P3 is required. No recent insider buying on the open market.
FN Summary: Lead asset (Exebacase) has fast-track & ‘breakthrough’ status and is in Superiority Phase 3 for MRSA. Pfizer is on the BOD and invested $6M. Possible new class of drug (lysins). $88M matching BARDA grant received. Missed Phase 2 endpoint, but MRSA subgroup discovered. Futility readout (for superiority) in 2H 2021. If futility readout shows superiority is on track, good possibility of a buyout.
What types of companies make it onto this list?
- Must have a genuinely good product that has potential (ie. good Phase 2 or even better, multiple Phase 2 trials to work out the kinks)
- Market Cap should be low ($50M-500M)
- Stock price is at, or near, all time low
- Have a drug pipeline vs. a device pipeline
- Enough cash until next catalyst (interim analysis or final readout)
- Should be in Phase 3
- Good management with minimal turnover
The following company was covered by FN at one time, but due to intense market competition, FN believes this company no longer presents a compelling investment. This page will no longer be updated as of 7/12/21
FN Rating: (not rated)
FN Summary: Lead asset (Yselty) for Uterine Fibroids P3 study achieved significant reduction in pain & MBL. It is also being tested for Endometriosis. There is significant competition from Myovant Sciences, which is in the exact same space, but ahead in drug development. OBSV also has Ebopiprant for preterm labor and will start a Phase 2b study in Q4 2021. OBSV will need to raise funds by the end of the year.