This article first appeared on GuruFocus .
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R&D Expense:$18.7 million in Q2 2026, compared to $17.2 million in the same period of 2025.
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G&A Expense:$7.6 million in Q2 2026, compared to $5.7 million in the prior-year quarter.
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Net Loss:$22.8 million, or $0.12 per share, in Q2 2026, compared to a net loss of $22.1 million, or $0.27 per share, in Q2 2025.
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Cash Position:Total cash of $519 million as of June 30, 2026.
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Capital Raised:Approximately $310 million raised year-to-date, including a $225 million follow-on offering in April.
Release Date: August 12, 2026
For the complete transcript of the earnings call, please refer to the full earnings call transcript .
Positive Points
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Initiated the global PERFORMA Phase 3 trial for MASH, with rapid site activation and strong engagement from the medical community.
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Reported positive top-line data from the RECLAIM Phase 2 trial in AUD, meeting primary and key secondary endpoints, including FDA-recognized registrational endpoints.
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Demonstrated potential liver benefits in AUD patients, with 50% of pemvidutide-treated patients showing improvement in FIB-4 index versus 17% for placebo.
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Completed patient enrollment in the RESTORE trial for ALD, with a protocol amendment to assess liver stiffness at both 48 and 24 weeks, strengthening the liver benefit assessment.
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Strong financial position with $519 million in cash, providing runway through the MASH Phase 3 52-week readout in 2029.
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AUD market presents significant unmet need with no new drug approvals in 20 years, and pemvidutide's dual mechanism could disrupt the market.
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Potential for non-dilutive funding for a Phase 3 AUD trial, including royalty, debt, or strategic partnerships.
Negative Points
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Phase 3 AUD trial is not yet funded, and the company plans to use non-dilutive means, which may not be guaranteed.
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Competitive landscape for MASH trials is intense, with multiple ongoing Phase 3 programs, potentially impacting patient enrollment.
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Discontinuation rates in the RECLAIM trial were similar between active and placebo arms, with GI-related AEs in the active arm, indicating tolerability concerns.
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The RESTORE trial's primary endpoint change to a hierarchical analysis may complicate regulatory interpretation and delay clear results.
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The company has not yet provided specific timing for the Phase 3 AUD trial, pending FDA feedback, which could delay progress.
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The AUD market has low diagnosis and treatment rates, which may require significant educational efforts to drive adoption.
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The company's cash runway does not include the AUD Phase 3 trial, and financing options are not yet secured.
Q & A Highlights
Q: For AUD, is conducting one global pivotal trial still the base case now that you're incorporating both FDA and EU requirements? A: Christophe Arbet-Engels, Chief Medical Officer, confirmed that based on recent FDA guidance, one trial should be sufficient. The guidance emphasizes the weight of evidence and quality of biomarkers, with PEth becoming more important. The company plans to leverage its additional experience with pemvidutide in other populations for the safety database, supporting a single pivotal Phase 3 trial in AUD, potentially including ALD patients, with synergies across programs.
Q: On the PERFORMA Phase 3 study, appreciate the comments on the regional targeting for the trial sites. I just wanted to ask about your sense of the competitive landscape for MASH trials since there are a number of competing Phase 3 programs at various stages of enrollment, and I was hoping you could provide a bit more detail on how you're targeting study sites with respect to competing programs. How much overlap is there with some of these ongoing pivotal programs, and maybe if you could talk about your expectations on patient enrollment relative to some of the other Phase 3 programs, or semaglutide, or survodutide? A: Jerome Durso, CEO, noted the company is encouraged by the speed of initiation. Christophe Arbet-Engels, CMO, added that the trial will span ~290-300 sites globally. They are leveraging the AIM-MASH design to reduce screen failures and their existing site relationships. Enrollment is expected to take 18-24 months, with the company aiming for the lower end of that range due to the study's attractive features for investigators.
Q: Do you plan to share any subgroup analyses from the RECLAIM AUD trial? And are there any patient segments where efficacy appears particularly compelling? And second, could you share any additional detail on how you're thinking about Phase 3 timing, trial design, and funding? A: Christophe Arbet-Engels, CMO, confirmed they will continue to analyze data and present at future medical conferences. For Phase 3, they plan to establish the liver benefits given the AUD-ALD overlap, broaden the population to include patients with BMI under 25, and likely have a 24-week primary efficacy endpoint with additional analysis out to 52 weeks. Jerome Durso, CEO, added they are not yet guiding on timing but will work quickly to compile the full data package for an end of Phase 2 meeting with the FDA.
Q: I'm curious about the follow-up from the AUD study. So I think it's pretty well known that with the weight loss drugs, there's rebound when patients stop taking the injections and there's persistence problems. And so when you think about AUD, has there been any follow-up study on these patients to see how they behave after they stop treatment? Is there a rebound in their heavy drinking? And is there any work being done in trying to maintain a persistence of treatment on this drug? A: Linda Richardson, Chief Commercial Officer, noted that competitive therapies often suffer from patients being unable to tolerate them, leading to discontinuation. She highlighted pemvidutide's favorable tolerability profile as a potential advantage. Christophe Arbet-Engels, CMO, added that the RECLAIM study was not designed to formally assess rebound, but they will examine follow-up data. He emphasized that FDA guidance recognizes AUD as a chronic disease, and pemvidutide's safety and tolerability profile supports long-term chronic use, which will be further evaluated in Phase 3.
Q: Starting the Phase 3 programs and AUD especially considering it's not fully funded while leveraging the ongoing Phase 3 MASH trial. When would you kind of decide to allocate additional funds and what would you need to see to do that? A: Gregory Weaver, CFO, explained that the next steps involve feedback from the FDA at the end of Phase 2 meeting, which will allow them to design and cost the Phase 3 AUD trial. They anticipate it will be significantly less costly than the MASH Phase 3. Financing is expected in the new year, with a preference for non-dilutive funding options such as strategic partnerships, debt, or royalties. He reiterated the strong balance sheet with $519 million in cash, providing runway through the MASH Phase 3 readout in 2029.
Q: Just a few follow-up questions on PERFORMA and MASH. I was wondering first if there was a read-through or learnings from the Phase 2 RECLAIM trial and AUD around the 2.4 milligram discontinuations and how that might change titration monitoring or dose reduction plan for the 2.4 milligram arm in PERFORMA. And then as well in PERFORMA, I'm wondering if you're going to be allowing background GLP-1 therapy, resmetirom, or other directed therapies, and how you could manage patients who want to initiate or resume those therapies during the 52-week biopsy period. A: Christophe Arbet-Engels, CMO, stated that learnings from the AUD trial support a simple, favorable titration schedule for the 2.4 mg dose in PERFORMA. Regarding background therapies, GLP-1s will be allowed only at anti-diabetic doses, while resmetirom will be excluded to avoid jeopardizing the primary endpoint. The trial will collect history on patients who have failed prior therapies like GLP-1s or resmetirom to characterize the population.
Q: Just looking back over the past year and sort of the changes in some of the ALD inclusion requirements, it looks like you've increased your liver stiffness that you're allowing into the trial from about 18.5 up to about 25. I was wondering if you could speak to sort of how you expect that or why, you know, that change may have been occurring, you know, possibly being able to provide any details on how the inclusion of severe, less severe population, and if that led into anything to do with the change in hierarchy for your primary endpoint. A: Christophe Arbet-Engels, CMO, clarified that the change in liver stiffness inclusion criteria is unrelated to the hierarchical primary endpoint change. The criteria expansion was based on learnings from a hepatic impairment study that showed no risk in the broader population. The hierarchical procedure at week 48 is specifically designed to strengthen understanding of pemvidutide's liver benefits and support regulatory discussions.
Q: Maybe one more on the RESTORE study and about liver stiffness. So the upper end of that range, 10 to 25. The upper range is suggestive of a cirrhotic features for these patients. I'm curious, if the data is supportive in that segment, and how would you use that data, potential read-throughs
For the complete transcript of the earnings call, please refer to the full earnings call transcript .
