Key points
- Altimmune’s Phase 2 clinical trials of the GLP-1/glucagon drug Pemvidutide had promising results as the maximum dosage of 2.4 mg per week led to an average weight loss of 15.6%, 48% of patients he was no longer classified as obese and the loss of lean mass was 25.5. % versus 39% for Ozempic and Wegovy.
- The issue was tolerability, with a discontinuation rate of 15.5% for adverse side effects (AEs) compared to 6.8% for Wegovy and 2% for placebo.
- Altimmune had $198 million in cash and cash equivalents at the end of the fourth quarter of 2023, but GAAP losses in the quarter were $31.6 million.
- 5 titles we like most about Altimmune
Altimmune Inc. NASDAQ:ALT is a clinical-stage biotechnology company specializing in the treatment of liver disease and obesity. Their lead drug, Pemvidutide, has garnered a lot of attention as a GLP-1/glucagon dual agonist similar to the weight-loss treatments Mounjaro and Zepbound by Eli Lilly and Co. NYSE: LLY. The semaglutide revolution triggered a GLP-1 gold rush in the medical sector, driven by the success of Ozempic and Wegovy, produced by Novo Nordisk A/S NYSE: NVO. The market is eagerly seeking new treatments for GLP-1 obesity and is bidding up promising candidate stocks, as evidenced by the 310% year-to-date (YTD) performance for Viking Therapeutics Inc. NASDAQ: VKTX shares thanks to the lead drug GLP-1/glucagon VK2735.
The double threat of Pemvidutide
Altimmune’s lead candidate, Pemvidutide, addresses both obesity and liver disease as both may be linked. Nonalcoholic steatohepatitis (NASH) is fatty liver not caused by alcohol. When fat builds up in the liver, it can lead to fibrosis (buildup of scar tissue) and cirrhosis (hardening of the liver), which can lead to liver cancer. Nearly 70%-80% of NASH patients suffer from obesity. A third disorder that Pemvidutide could address is steatohepatitis associated with metabolic dysfunction (MASH), addressed in the IMPACT Phase 2b trial. The FDA has granted an expedited designation to MASH. Results of the study are expected in the first quarter of 2025.
How pemvidutide works
Pemvidutide is a new and experimental peptide that affects two hormones. Glucagon-like peptide (GLP-1) is a receptor that stimulates insulin secretion by suppressing glucagon secretion. Insulin helps reduce blood sugar by promoting the uptake of glucose by cells, while glucagon reacts in the opposite way by increasing sugar levels. Glucagon promotes fat burning in tissues, including the liver. GLP-1 suppresses appetite by inducing feelings of satiety, while insulin production regulates blood sugar levels, which can improve metabolic health. Increased activity of glucagon receptors promotes fat burning, leading to a reduction of fat in the liver.
Daily descending triangle
The daily candlestick chart on ALT illustrates a descending triangle pattern. The descending trendline formed at the high of $14.84 on February 28, 2024, limiting bounces to lower highs. The flat bottomed lower trendline is at $8.51 and is met at the apex point. The ALT will soon break above the upper trendline or break the flat-bottomed lower trendline. The daily relative strength index (RSI) is moving sideways in the 45 band. The pullback support levels are at $8.51, $7.92, $6.94, and $5.56.
Good news: weight loss, fat reduction and lean body mass preservation
Altimmune’s initial topline results from the MOMENTUM Phase 2 clinical trials were considered positive. Weight loss averaged 15.6% with the highest dose and 10.3% with the lowest dose of 1.2 mg. Nearly 48% of patients in the 48-week study who were initially classified as obese, with a body mass index of 30 or higher, no longer qualified as obese at the end of the study.
Furthermore, lean mass preservation was also prevalent, as 25.5% of the weight loss came from lean mass loss compared to 39% lean mass loss with GLP-1 drugs such as Ozempic. Pemvidutide showed significant liver loss without increases in heart rate. Up to 78.6% of patients with excess liver fat have normalized their fat content.
Bad news: tolerability and dropout rates
One major drawback was the gastrointestinal discomfort caused by a GLP-1/glucagon dual agonist. GLP-1 is known to cause gastrointestinal problems, but glucagon stimulation can exacerbate the problem. Tolerability has been an issue with Pemvidutide as the discontinuation rate increased with higher doses. Adverse effects (AEs) are unfavorable, unintended symptoms that can range from mild nausea to severe allergic reactions to organ failure.
Serious adverse effects (SAEs) are those that are potentially life-threatening, require hospitalization, or cause significant disability. At the maximum dose of 2.4 mg per week, drug-related adverse event discontinuations increased to 15.5%, compared to 2.1% for placebo or 6.6% for Wegovy. Nearly 50% of participants experienced nausea, 27.8% vomiting, and 18.6% diarrhea at the highest dose.
Liquidity crisis and dilution
Altimmune reported total cash and cash equivalents of $198 million at the end of December 31, 2023, following net losses of $31.6 million in the quarter. Altimmune has market authorization (ATM) to sell up to $135.7 million in shares again.
Standing for a hero
The hope is that a big pharma whale will soon come on board as a partner to offset research costs and collaborate for a potential launch if it gets FDA approval. Altimmune has had a history of launch failures or launch delays, such as its adCOVID vaccine, which failed its Phase 1 clinical trials by failing to produce an adequate immune response in 2021.
Altimmune analyst ratings and price targets I’m on MarketBeat. Altimmune peers and competitor actions can be found with MarketBeat Stock Screener. Altimmune has a short share of 17.65%.
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