Personal opinion
- ALT is providing a liver fatty solution through regulatory pathways that are covered by INSURANCE, to the core they do address Obesity – but do not go along with the hype.
- The Obesity/MASH/NASH market is growing. Diabetes and such liver fatty related health issues will grow. Ozempic and such, expensive and hard to get – black market abuse likely to cause problems. Alternatives through a doctor and covered by insurance, much needed.
- ALT stated clearly: No Phase 3 without partner. 2 options:
- Since no new CFO, they will sell the pipeline. The pipeline is very much connected, one partner for one product would not make sense.
- They will present a partner very soon, as they also stated a partner is preferred in trial design and should preferably be present at the FDA meeting next month.
- This will fund the company further
- This will make short sellers cover
About Pemvidutide
Pemvidutide is a novel, investigational, peptide-based GLP-1/glucagon dual receptor agonist in development for the treatment of obesity and MASH. Activation of the GLP-1 and glucagon receptors is believed to mimic the complementary effects of diet and exercise on weight loss, with GLP-1 suppressing appetite and glucagon increasing energy expenditure. Glucagon is also recognized as having direct effects on hepatic fat metabolism, which is believed to lead to rapid reductions in levels of liver fat and serum lipids. In clinical trials to date, once-weekly pemvidutide has demonstrated compelling weight loss, robust reductions in triglycerides, LDL cholesterol, liver fat content and blood pressure. The U.S. FDA has granted Fast Track designation to pemvidutide for the treatment of MASH. Pemvidutide recently completed the MOMENTUM Phase 2 obesity trial and is being studied in the ongoing IMPACT Phase 2b MASH trial.
- Recent HCW webcast – easy to follow.
- Recent PR
- IMPACT trial is evaluating the safety and efficacy of pemvidutide in approximately 190 subjects with MASH; top-line efficacy data expected in Q2 2025
- End-of-Phase 2 Meeting for the obesity program with U.S. Food and Drug Administration (FDA) has been scheduled for early November 2024
- Company plans to submit Investigational New Drug (IND) applications for pemvidutide in up to three additional indications beginning in Q4 2024
- ON THE FDA MEETING
- CEO has repeatedly said a partner would be preferred to be at the table. CEO has been dangling the partner desire for OVER A YEAR. IF any partner is announced, it will be in the next to weeks.
- What will a partner mean?
- A fully funded Phase 3 trial. Which means a Viking-like trajectory for ALT, or at least a bump to 21$
- How will the latter come about?
- 30% Short Interest
- 11 Days to cover 21 million shares
- What makes ALT stand out?
- Lean Muscle preservation
- The wide indications are aimed at insurance covered issues (fatty liver, which all obese people have) – they do not market themselves as an obesity stock.
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