Virtual Expo Preview- John McCamant
Five Prime (FPRX) follows Pharmacyclics, Medicines Company and Celgene, as stocks in The Medical Technology Stock Letter portfolio to be acquired in recent years. Here, editor John McCamant looks at 2 other stocks in his model portfolio that he feels could eventually join this list.
We continue to believe that the majority of our universe of recommendations are potential takeover candidates — especially those with wholly-owned assets, which was the case with Five Prime. Examples of current candidates with key lead stand-alone compounds are Madrigal Pharmaceuticals (MDGL) and Precigen (PGEN).
More from John McCamant: Nektar Gets Support from Innovative Collaborations
Madrigal is developing novel, high-quality small-molecule drugs targeting treatment of both niche and prevalent indications, including fatty liver disease and non-alcoholic steatohepatitis (NASH), diabetes, dyslipidemia and cardiovascular disease.
The company recently reported their Q4 financials. Importantly, in the Phase III MAESTRO-NAFLD-1 trial enrollment is now complete with 52-week controlled data expected by YE:21. The trial was enlarged to 1,200 patients from the original enrollment target of 700 patients to enhance the safety database and while also providing for more robust subgroup analyses.
Management has announced plans to complete enrollment in the serial liver biopsy portion of the Phase III MAESTRO-NASH trial by Q2:21 and given the 52-week endpoint, we expect data in Q2:22. The Company also expects to present data from the open label arm of the MAESTRO-NAFLD-1 study at a major medical conference this year.
In our view, resmetirom remains the leading drug in development to treat both NASH and NAFLD. An extremely safe once-a-day pill that acts early in the development of NASH or even prevents it from occurring by significantly reducing inflammation.
In addition, the spate of competitor setbacks has added to Madrigal's lead and also points the importance of safety when developing drugs to treat chronic disease.
We expect the Phase III MAESTRO-NAFLD-1 trial data to be positive which would significantly de-risk the read through for the Phase III MAESTRO-NASH trial. Potential acquirers would also see resmetirom as a de-risked drug candidate and a bidding war could ensue for asset that could be a multi-billion drug.
Precigen — involved in gene and cell therapies — had an excellent 2020 as they turned the company around with a tight focus on delivering proof-of-concept data. Management took advantage of their execution last year and in January raised $129 million to fund their advancing gene and cell therapy pipeline.
See also: Thermo-Fisher: The Top Pick in Healthcare
The initial data readouts from PRGN-3005 and PRGN-3006 UltraCAR-T® clinical trials demonstrated encouraging expansion, persistence and clinical activity in 2020. Both of these trials are expanding in 2021 and we can expect additional interim data readouts for each program during the year.
In our view, Precigen's management team will continue to execute in 2021 and create shareholder value by delivering positive clinical data. Management will presenting at the upcoming Wainwright Virtual Global Life Science Conference on March 9 at 7:00AM EST. Catch it online.
Also in 2020, Precigen initiated the first AdenoVerse immunotherapy clinical trial for PRGN-2009 in HPV-associated solid tumors. PRGN-2009 is a first-in-class, off-the-shelf (OTS) investigational immunotherapy utilizing the AdenoVerse platform in an ongoing Phase I/II clinical study designed to activate the immune system to recognize and target HPV+ solid tumors.
In 2021, we expect ‘2009 to deliver their first POC data which should serve as yet another significant stock catalyst, just as the initial POC data for ‘3005 and ‘3006 did in 2020. Precigen has become one of our most exciting recommendations and is a Top Pick for 2021.
More From MoneyShow.com:
