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 results due Q1 2022. Newly acquired E7777 cancer drug for CTCL P3 results due 1H 2022. All-star management has 1) invested side-by-side with the investors, and 2) a long history of biotech product successes.
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: 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, SP should start to climb.
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
- Management buying in at market prices if SP is at all time low (very important!)
Biotechs that reached P3 trial end and no longer are followed b/c the largest catalyst is past.
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. Targeting several unmet medical needs in large markets.
ATNF hit their P3 endpoints, but the SP did not increase after the trial.
FN Summary: Lead asset (Durlobactam) to treat CRAB is in P3 clinical trials. Existing treatments for CRAB have a 50% mortality rate. Phase 2 results were good and non-inferiority Phase 3 trial is progressing nicely with full enrollment completed in July. Good insider ownership, but is primarily one company who sits on the BOD. Company also has an oral drug to treat gonorrhea, which is also in Phase 3, but Covid seems to be slowing enrollment.
Entasis hit their P3 endpoints, but the SP did not increase after the trial.
On Sept 7, 2021 FN stopped covering OMER. We have discovered other biotechs with smaller market caps since publishing this page. We believe those companies present better risk-reward opportunities and will focus on those.
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. Company receives cash from OMIDRIA sales and has good cash reserves.
On Aug 31, 2021 FN stopped covering ACHV. This company requires a 2nd Phase 3 trial, which will not start until 2H 2022. This timeline puts the final P3 catalyst more than 9 month out, which is outside the ideal FN window for investment.
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.
OBSV 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.