Altimmune (NASDAQ:ALT) has made great progress in advancing several clinical products in its pipeline. In particular, it had already released results from its phase 2 MOMENTUM study, which used pemvidutide for the treatment of patients with obesity, back in March 2023. With this clinical data only being 24-week data, there is an opportunity for investors with respect to an upcoming catalyst. It is expected that in Q4 of 2023, it intends to release 48-week data from this very same phase 2 MOMENTUM study. Another catalyst which is expected around mid-2023, would be the initiation of the phase 2b IMPACT study, which is using pemvidutide for the treatment of patients with non-alcoholic steatohepatitis. If this mid-stage study initiates around the expected time frame, then it is expected that final results from this phase 2b IMPACT study, will be released by Q1 of 2025. Altimmune is also working on advancing a candidate known as HepTcell in a phase 2 trial, which it hopes might end up becoming a functional cure for patients with chronic Hepatitis B. Results from this study using HepTcell for the treatment of this patient population are expected by Q1 of 2024.
48-Week MOMENTUM Study Data Might Be A Huge Turning Point
As I stated above, Altimmune is gearing up for a major catalyst. That is, it expects to report 48-week results from the phase 2 MOMENTUM study, which is using pemvidutide for the treatment of patients with obesity. Results from this mid-stage study are expected to be released by Q4 of 2023. Obesity is a type of disorder whereby excess body fat causes a multitude of health issues. It occurs when a person takes in more calories than are burned by exercise or other normal daily activities. One thing to note is that obesity is far different from that of being overweight. That’s because to be considered overweight is where there is a body mass index [BMI] of over 25. On the other hand, when someone is obese, they have a BMI of over 30. There is no main symptom for patients who are obese, just that having a huge amount of excessive body fat causes an increase in risk for many types of serious health problems.
It is going to be a huge market to go after, should this company ultimately be successful in advancing pemvidutide past phase 2 and phase 3 testing, along with receiving regulatory approvals for it. It is expected that the global obesity market is expected to reach $31.1 billion across the seven major markets by 2031. While this is a multi-billion dollar market opportunity for this company, there is one major item to consider and that would be a lot of competition. That’s because there are already a lot of players in this space. For instance, Eli Lilly (LLY) already successfully completed its phase 3 study using its drug tirzepatide for obesity. A decision upon whether or not the FDA will approve this drug for the treatment of patients with obesity may come by late 2023. However, the market leader at the moment would be Novo Nordisk (NVO), which is already marketing two weight loss drugs known as OZEMPIC and WEGOVY. One thing to note about OZEMPIC is that it has not been approved by the FDA for weight loss, but might be used as off-label for weight loss. Where Eli Lilly might shine later on, is with respect to a head-to-head study it is doing. That is, where it is advancing a 700-patient study that would put its weight loss drug tirzepatide against WEGOVY. This study is expected to completed in 2025 and if its drug achieves an edge, then it might create a competitive advantage. In order for Altimmune to do well in this space with pemvidutide, it will have to achieve equivalent or superior weight loss.
The positive data released back in March 2023, was an interim analysis for the 24-week portion of the phase 2 MOMENTUM study. These patients were randomized 1:1:1:1 to receive one of the following doses:
- 1.2 mg of pemvidutide.
- 1.8 mg of pemvidutide.
- 2.4 mg of pemvidutide.
- Placebo.
One thing to note is that patients in this study were given one of these treatment options in conjunction with diet and exercise for a total of 48 weeks. The interim analysis that was done for 24-weeks established some pretty good weight loss. At Week-24 it was noted that patients given 1.2 mg, 1.8 mg and 2.4 mg had achieved mean weight loss of 7.3%, 9.4% and 10.7% respectively. On the other hand, the placebo group had only achieved a mean weight loss of 1%. There is a catalyst opportunity for investors to look forward to with respect to this program, which involves the release of 48-week results from this same phase 2 MOMENTUM study, which is using pemvidutide for the treatment of patients with obesity. Such results are expected to be released in Q4 of 2023.
Financials
According to the 10-Q SEC Filing, Altimmune had cash, cash equivalents and short-term investments of $165.8 million as of March 31, 2023. This biotech is likely going to have to raise cash in the coming months. The reason why I state that is, because it states that it has enough cash on hand to fund its operations for at least the next 12-months from the date of the 10-Q SEC filing, which was filed on May 11, 2023. However, it does have an option it can take, should it need to raise additional funds. That is, back on February 28, 2023 it entered into an Equity Distribution Agreement [2023 Agreement] with Evercore Group L.L.C., JMP Securities LLC and B. Riley Securities, Inc., serving as sales agents. Therefore, from time to time Altimmune can choose to sell shares of its common stock with an aggregate offering price of up to $150 million. During the three months ending March 31, 2023, no shares have been sold under this 2023 Agreement and $150 million still remains available to be used under it. I believe that a cash raise might be done upon the release of results from the 48-week phase 2 MOMENTUM study data. Of course, that will only happen if the results turn out to be good and the stock trades higher because of it.
Risks To Business
There are several risks that investors should be aware of before investing in Altimmune. The first risk to consider would be with respect to the release of 48-week results from the phase 2 MOMENTUM study, which is using pemvidutide for the treatment of patients with obesity. These results are expected in Q4 of 2023. Even though the 24-week data which was released was positive, there is no guarantee that the 48-week portion of the study will also turn out to be good. A second risk to consider would be with respect to other competitors as noted directly above. That’s because any data released from this phase 2 MOMENTUM study will be scrutinized with respect to other obesity drugs like WEGOVY, OZEMPIC and tirzepatide. A third risk would be with respect to the ongoing phase 2 trial, which is using HepTcell for the treatment of patients with chronic Hepatitis B. These results are expected to be released by Q1 of 2024. There is no guarantee that the results to be released from this study will be positive. A fourth risk to consider would be with respect to its financial position as I noted above. Again, it only believes that it has enough cash on hand to fund its operations for the next 12 months. As such, it is likely going to have to dilute in the coming months.
Conclusion
The company has already released 24-week data from its phase 2 MOMENTUM study, which is using pemvidutide for the treatment of patients with obesity. At Week-24 it was noted that patients given 1.2 mg, 1.8 mg and 2.4 mg had achieved mean weight loss of 7.3%, 9.4% and 10.7% respectively. It remains to be seen what the next set of weight loss percentages are, but so far, the data appears to the drug to be active in being able to help patients lose weight. There is an additional catalyst opportunity with respect to a data readout in Q1 of 2024. This would be the release of results from the phase 2 study, which is using HepTcell for the treatment of patients with chronic Hepatitis B. A smaller catalyst, which is expected in Q4 of 2023, would be the initiation of a phase 2b study using pemvidutide for the treatment of patients with NASH. However, investors won’t get to see results from this NASH study until at least Q1 of 2025. With proof-of-concept of pemvidutide for the treatment of patients with obesity established, plus a few catalysts approaching within a 1-year time frame, I believe that investors might be able to capitalize on any possible gains made.
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