NONOF - Altimmune: Pemvidutide Data Reinforces Obesity Drug Outlook

2023-12-06 05:38:29 ET

Summary

• Positive results were achieved from the 48-week phase 2 MOMENTUM study using pemvidutide for the treatment of patients with obesity.
• The highest dose of 2.4 mg of pemvidutide achieved 15.6% weight loss for obese patients.
• Altimmune has two other upcoming catalysts: phase 2 study results for Hepatitis B treatment in Q1 2024 and phase 2b IMPACT trial results for NASH treatment in Q1 2025.
• The obesity drugs market is expected to be a $100 billion opportunity by 2030.

Altimmune ( ALT ) has been making good progress in advancing its pipeline lately. The last time I spoke about this biotech I noted that it was set to release 48-week results from its phase 2 MOMENTUM study using its drug pemvidutide for the treatment of patients with obesity. I mentioned in this in a prior Seeking Alpha article titled " Altimmune: Obesity Trial Data Release Q4 Of 2023 ". Well, the company has achieved a successful outcome for this study, because it just announced positive results from this 48-week phase 2 MOMENTUM obesity study. One analyst noted that the data exceeds other available drugs out on the market for weight loss.

Why do I believe that there is still momentum with respect to this biotech? It is because there are still two other catalysts on the way in the coming years. Should such other results turn out to be positive, then these could also increase shareholder value. The first of which involves what I noted the last time, which is that top-line data from the phase 2 study using HepTcell for the treatment of patients with Hepatitis B is expected in Q1 of 2024. Besides this, the company is also testing out pemvidutide for another indication in its pipeline, which is for the treatment of patients with non-alcoholic steatohepatitis [NASH]. The use of pemvidutide for the treatment of this specific patient population is being explored in the ongoing phase 2b IMPACT trial. Top-line 24-week data from this study is expected to be released in Q1 of 2025.

Positive Pemvidutide Data For Obesity Is Only The Beginning

As I noted above, Altimmune just reported positive results from the phase 2 MOMENTUM study , which explored the use pemvidutide for the treatment of patients with obesity. However, it is important to note that this was 48-week data for these patients who were given this drug. A total of 391 patients with obesity or who were overweight [also without diabetes] were randomized into one of these treatment arms, along with the following average weight loss percentage achieved:

• 1.2 mg pemvidutide - 10.3%
• 1.8 mg pemvidutide - 11.2%
• 2.4 mg pemvidutide - 15.6%
• Placebo - 2.2%

As you can see, the highest dose of 2.4 mg pemvidutide achieved the most weight loss for these patients, with a mean weight loss of 15.6% . Another important finding is that over 50% of patients achieved at least a 15% weight loss and then over 30% of patients achieved at least 20% weight loss on the 2.4 mg dose. Lastly, there is one other highly important efficacy finding to note, which is highly ideal. It was noted by Altimmune that patients given the 2.4 mg dose of the drug had a continued trajectory of weight loss with the 2.4 mg dose. Why was this an important finding to mention? That's because it shows that there was potential for greater weight loss if treatment continued on thereafter. Not only was there a good amount of weight loss for patients who took this drug but it was also shown that it could be highly competitive. That's because the biotech can differentiate itself against other approved drugs in the market with an improved safety profile. One analyst noted that it can compete well against the likes of MOUNJARO and Retatrutide from Eli Lilly ( LLY ) and WEGOVY/OZEMPIC from Novo Nordisk ( NVO ).

One Competitor Has Setback While Another One Emerges

This data by Altimmune was very good, however, there might be some competitors that it might have to eventually deal with. One such competitor is Roche ( OTCQX:RHHBY ), that's because it just spent $2.7 billion to acquire Carmot Therapeutics , along with the need to eventually pay milestone payments totaling $400 million. The reason why I believe Roche might be a competitor is because its acquisition of this small-cap biotech brought on board three therapeutics to treat obesity. The three clinical products that it got as part of buying this company are CT-388, CT-996, and CT-868 which are GLP-1/GIP receptor agonists, oral GLP-1 receptor agonists, and GLP-1/GIP receptor agonists respectively. The one drug to keep an eye on would be the lead asset which is phase 2 ready, which is CT-388. That's because in a phase 1 study after patients were treated over a 4-week period, it was noted that there was an 8% weight loss achieved during that time frame . Not only can the dosing regimen be adjusted along with titration achieved, but it is possible that this drug can be combined with another therapy for the potential of even more weight loss. Another possible competitor might be Pfizer ( PFE ), but this largely depends upon what happens in the first part of 2024. That's because it was forced to drop its program for its twice-daily oral version of danuglipron. It did so because most patients dropped out of this phase 2 trial due to high rates of side effects. If it failed with respect to twice-daily dosing of danuglipron, then how can it still possibly be a competitor? It is because Pfizer is shifting to a once-daily version of this drug to treat obese patients instead. However, a new formulation of this drug it is working on to possibly reduce any side effects with one daily dosing, won't be ready until the 1st half of 2024. Thus, it's too early to say whether or not big pharma can ultimately succeed in competing in this obesity space with danuglipron.

Financials

According to the 10-Q SEC Filing , Altimmune had cash, cash equivalents and short-term investments of $140.8 million as of September 30, 2023. It believes that it has enough cash on hand to fund its operations for at least the next 12 months from the date of its SEC Filing, which was filed on November 7, 2023. The thing is that this biotech has an "at-the-market" offering it can use to raise cash. This was an at-the-market offering agreement that was entered into with Evercore Group L.L.C, JMP Securities LLC, and B. Riley Securities Incorporated back on February 28, 2023.

Such an agreement was made so that Altimmune can from time to time sell shares of its common stock at its sole discretion with an aggregate offering price of $150 million. During the 9 months ending September 30, 2023, it sold 3,536,284 shares of its common stock under this agreement, which resulted in $13.9 million in net proceeds. Despite issuing the sale of some shares of its common stock, it still has a total of $135.7 million remaining under this "at-the-market" offering program. Thus, it is quite possible that it could choose to raise cash immediately, especially since it just released positive 48-week results from its phase 2 MOMENTUM study.

The company had spent approximately $18.4 million in Q3 of 2023, compared to $20.3 million spent in the same time period in 2022. The biggest cost came from the pemvidutide program, whereby there was a cost of approximately $12 million during the quarter. This was largely due to the fact that there was increase in cost in terms of the IMPACT trial, which is using pemvidutide to treat obesity and NASH. This is in regards to the ramp up cost associated with this trial. Despite this ramp up rise in costs this is not going to be an issue going forward. Why do I state that? That's because any cost increase that occurs with the IMPACT study is going to be offset by reductions of costs expected to occur as the MOMENTUM study starts to wind down.

Risks To Business

There are several risks that investors should be aware of before investing in Altimmune. The first risk would be with respect to the 48-week results that were just released from the phase 2 MOMENTUM study, which used pemvidutide for the treatment of patients with obesity. That's because despite receiving positive results from this mid-stage study, there is no guarantee that similar or superior results will be released from the next phase 3 study. A second risk to consider would be the competition in place in the obesity market. I state that because by the time pemvidutide reaches the market/approved [if it gets through all trials successfully], Eli Lilly and Novo Nordisk would have carved out a huge chunk of the obesity market. Still, there might be plenty of room for additional players.

Especially, if Altimmune's drug provides some competitive advantages over these other obesity drugs. Matter of fact, the obesity drugs market is expected to be a $100 billion opportunity by 2030 . A third risk to consider would be with respect to the ongoing phase 2 study, which is using HepTcell for the treatment of patients with Hepatitis B. There is no guarantee that this pipeline candidate is going to succeed in this mid-stage study. The fourth and final risk to consider would be with respect to the use of pemvidutide, which is also being advanced for the treatment of patients with NASH. Even though the 2.4 mg dose of this drug performed well in establishing a mean weight loss of 15.6% for these obese patients, there is no guarantee that it will translate to successful results in the other NASH indications.

Conclusion

Altimmune has made a good amount of progress in being able to advance pemvidutide for the treatment of patients with obesity and NASH. It just reported positive results from its phase 2 MOMENTUM study, which used this drug to treat patients with obesity. As I stated above, an analyst notes that it might be able to compete well against several other pharmaceutical companies in the obesity market, in that its drug might provide some competitive advantages. I believe it was good to go over this biotech because there are still two other data readouts that are approaching over the next few years, which might be enough to cause the stock price to trade higher. The first of which is rapidly approaching, which is the release of results from the phase 2 study using HepTcell for the treatment of patients with Hepatitis B.

The other catalyst is only roughly one year away, but would still be a major inflection point for Altimmune. This would be the release of results from the phase 2b IMPACT trial, which is using pemvidutide for the treatment of patients with NASH. The primary endpoints of this mid-stage study are going to be NASH resolution and fibrosis improvement after 24 weeks of treatment. Such results are anticipated in Q1 of 2025. This is another large market opportunity for this company to go after for sure, which means pemvidutide has the potential to target two multibillion-dollar markets. The global non-alcoholic steatohepatitis market is projected to reach $21.4 billion by 2025 . With positive data released from the phase 2 obesity study, plus the few other catalysts that are expected in the coming years, I believe that investors might be able to capitalize on any potential gains made.

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