ALT
AltimmuneDDocument history
Earnings documents stored for ALT.
Investor releaseQuarter not tagged2026-09-11Why Is Altimmune (ALT) Up 14.2% Since Last Earnings Report?
Zacks
Why Is Altimmune (ALT) Up 14.2% Since Last Earnings Report?
It has been about a month since the last earnings report for Altimmune, Inc. (ALT). Shares have added about 14.2% in that time frame, outperforming the S&P 500. Will the recent positive trend continue leading up to its next earnings release, or is Altimmune due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at its most recent earnings report in order to get a better handle on the important drivers. Altimmune’s Q2 Loss Narrower Than Expected, Revenues Nil Altimmune incurred a second-quarter 2026 loss of 12 cents per share, narrower than the Zacks Consensus Estimate of a loss of 15 cents. The company had recorded a loss of 27 cents per share in the year-ago quarter.The company did not generate any revenues in the quarter, as it does not have a marketed drug in its portfolio. ALT's Q2 Results in Detail Research and development (R&D) expenses totaled $18.7 million in the reported quarter, up 8.2% year over year, primarily due to ongoing clinical studies and startup costs associated with the late-stage metabolic dysfunction-associated steatohepatitis (MASH) study onpemvidutide. R&D spending included $11.6 million in direct pemvidutide development costs.General and administrative expenses were $7.6 million, up 33.1% year over year, primarily driven by an increase in professional services and compensation expenses.As of June 30, 2026, Altimmune had cash, cash equivalents and short-term investments of $519 million compared with $332 million as of March 31, 2026. Management expects its cash runway to support operations into 2029. In the past month, investors have witnessed a upward trend in estimates review. The consensus estimate has shifted 11.29% due to these changes. Currently, Altimmune has a poor Growth Score of F, however its Momentum Score is doing a lot better with a C. However, the stock was allocated a grade of F on the value side, putting it in the fifth quintile for value investors. Overall, the stock has an aggregate VGM Score of F. If you aren't focused on one strategy, this score is the one you should be interested in. Estimates have been broadly trending upward for the stock, and the magnitude of these revisions looks promising. Notably, Altimmune has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. Altimmune belongs to the Zacks Medical - Drugs…Read full documentShow less
It has been about a month since the last earnings report for Altimmune, Inc. (ALT). Shares have added about 14.2% in that time frame, outperforming the S&P 500. Will the recent positive trend continue leading up to its next earnings release, or is Altimmune due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at its most recent earnings report in order to get a better handle on the important drivers. Altimmune’s Q2 Loss Narrower Than Expected, Revenues Nil Altimmune incurred a second-quarter 2026 loss of 12 cents per share, narrower than the Zacks Consensus Estimate of a loss of 15 cents. The company had recorded a loss of 27 cents per share in the year-ago quarter.The company did not generate any revenues in the quarter, as it does not have a marketed drug in its portfolio. ALT's Q2 Results in Detail Research and development (R&D) expenses totaled $18.7 million in the reported quarter, up 8.2% year over year, primarily due to ongoing clinical studies and startup costs associated with the late-stage metabolic dysfunction-associated steatohepatitis (MASH) study onpemvidutide. R&D spending included $11.6 million in direct pemvidutide development costs.General and administrative expenses were $7.6 million, up 33.1% year over year, primarily driven by an increase in professional services and compensation expenses.As of June 30, 2026, Altimmune had cash, cash equivalents and short-term investments of $519 million compared with $332 million as of March 31, 2026. Management expects its cash runway to support operations into 2029. In the past month, investors have witnessed a upward trend in estimates review. The consensus estimate has shifted 11.29% due to these changes. Currently, Altimmune has a poor Growth Score of F, however its Momentum Score is doing a lot better with a C. However, the stock was allocated a grade of F on the value side, putting it in the fifth quintile for value investors. Overall, the stock has an aggregate VGM Score of F. If you aren't focused on one strategy, this score is the one you should be interested in. Estimates have been broadly trending upward for the stock, and the magnitude of these revisions looks promising. Notably, Altimmune has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. Altimmune belongs to the Zacks Medical - Drugs industry. Another stock from the same industry, United Therapeutics (UTHR), has gained 0.5% over the past month. More than a month has passed since the company reported results for the quarter ended June 2026. United Therapeutics reported revenues of $783.3 million in the last reported quarter, representing a year-over-year change of -1.9%. EPS of $7.27 for the same period compares with $6.41 a year ago. For the current quarter, United Therapeutics is expected to post earnings of $6.47 per share, indicating a change of -9.6% from the year-ago quarter. The Zacks Consensus Estimate remained unchanged over the last 30 days. United Therapeutics has a Zacks Rank #3 (Hold) based on the overall direction and magnitude of estimate revisions. Additionally, the stock has a VGM Score of C. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Altimmune, Inc. (ALT) : Free Stock Analysis Report United Therapeutics Corporation (UTHR) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2026-08-12Altimmune Inc (ALT) (Q2 2026) Earnings Call Highlights: Advancing MASH and AUD Pipelines with ...
GuruFocus.com
Altimmune Inc (ALT) (Q2 2026) Earnings Call Highlights: Advancing MASH and AUD Pipelines with ...
This article first appeared on GuruFocus. R&D Expense: $18.7 million in Q2 2026, compared to $17.2 million in the same period of 2025. G&A Expense: $7.6 million in Q2 2026, compared to $5.7 million in the prior-year quarter. 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. Cash Position: Total cash of $519 million as of June 30, 2026. Capital Raised: Approximately $310 million raised year-to-date, including a $225 million follow-on offering in April. Warning! GuruFocus has detected 2 Warning Signs with ALT. Is ALT fairly valued? Test your thesis with our free DCF calculator. Release Date: August 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Initiated the global PERFORMA Phase 3 trial for MASH, with rapid site activation and strong engagement from the medical community. Reported positive top-line data from the RECLAIM Phase 2 trial in AUD, meeting primary and key secondary endpoints, including FDA-recognized registrational endpoints. Demonstrated potential liver benefits in AUD patients, with 50% of pemvidutide-treated patients showing improvement in FIB-4 index versus 17% for placebo. 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. Strong financial position with $519 million in cash, providing runway through the MASH Phase 3 52-week readout in 2029. AUD market presents significant unmet need with no new drug approvals in 20 years, and pemvidutide's dual mechanism could disrupt the market. Potential for non-dilutive funding for a Phase 3 AUD trial, including royalty, debt, or strategic partnerships. Phase 3 AUD trial is not yet funded, and the company plans to use non-dilutive means, which may not be guaranteed. Competitive landscape for MASH trials is intense, with multiple ongoing Phase 3 programs, potentially impacting patient enrollment. Discontinuation rates in the RECLAIM trial were similar between active and placebo arms, with GI-related AEs in the active arm, indicating tolerability concerns. The RESTORE trial's primary endpoint change to a hierarchical analysis may complicate regulatory interpretation and delay clear results. The company has not yet provided specific timing for…Read full documentShow less
This article first appeared on GuruFocus. R&D Expense: $18.7 million in Q2 2026, compared to $17.2 million in the same period of 2025. G&A Expense: $7.6 million in Q2 2026, compared to $5.7 million in the prior-year quarter. 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. Cash Position: Total cash of $519 million as of June 30, 2026. Capital Raised: Approximately $310 million raised year-to-date, including a $225 million follow-on offering in April. Warning! GuruFocus has detected 2 Warning Signs with ALT. Is ALT fairly valued? Test your thesis with our free DCF calculator. Release Date: August 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Initiated the global PERFORMA Phase 3 trial for MASH, with rapid site activation and strong engagement from the medical community. Reported positive top-line data from the RECLAIM Phase 2 trial in AUD, meeting primary and key secondary endpoints, including FDA-recognized registrational endpoints. Demonstrated potential liver benefits in AUD patients, with 50% of pemvidutide-treated patients showing improvement in FIB-4 index versus 17% for placebo. 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. Strong financial position with $519 million in cash, providing runway through the MASH Phase 3 52-week readout in 2029. AUD market presents significant unmet need with no new drug approvals in 20 years, and pemvidutide's dual mechanism could disrupt the market. Potential for non-dilutive funding for a Phase 3 AUD trial, including royalty, debt, or strategic partnerships. Phase 3 AUD trial is not yet funded, and the company plans to use non-dilutive means, which may not be guaranteed. Competitive landscape for MASH trials is intense, with multiple ongoing Phase 3 programs, potentially impacting patient enrollment. Discontinuation rates in the RECLAIM trial were similar between active and placebo arms, with GI-related AEs in the active arm, indicating tolerability concerns. The RESTORE trial's primary endpoint change to a hierarchical analysis may complicate regulatory interpretation and delay clear results. The company has not yet provided specific timing for the Phase 3 AUD trial, pending FDA feedback, which could delay progress. The AUD market has low diagnosis and treatment rates, which may require significant educational efforts to drive adoption. The company's cash runway does not include the AUD Phase 3 trial, and financing options are not yet secured. 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.
Investor releaseQuarter not tagged2026-08-12Altimmune Q2 Earnings Call Highlights
MarketBeat
Altimmune Q2 Earnings Call Highlights
Interested in Altimmune, Inc.? Here are five stocks we like better. Altimmune has begun enrolling its global Phase III PERFORMA trial of pemvidutide for MASH, with about 300 sites planned and 52-week data expected in 2029. The company is using AI-assisted pathology and expects its current cash to fund the program through that readout. Phase II results for pemvidutide in alcohol use disorder showed fewer heavy drinking days, more patients reaching lower-risk or zero heavy-drinking levels, and a 9.1% placebo-adjusted weight reduction. Altimmune is preparing for an FDA end-of-Phase-II meeting and may pursue a single global Phase III trial. Altimmune completed enrollment in its Phase II RESTORE trial for alcohol-associated liver disease, with topline results expected in the second half of 2027. The company reported a $22.8 million second-quarter net loss and $519 million in cash as of June 30, but would need additional or non-dilutive financing for a potential AUD Phase III program. MarketBeat Week in Review – 11/4 - 11/8 Altimmune (NASDAQ:ALT) said it has initiated patient enrollment in its global Phase III PERFORMA trial of pemvidutide for metabolic dysfunction-associated steatohepatitis, or MASH, while advancing plans for later-stage development in alcohol use disorder, or AUD. Chairman and Chief Executive Officer Jerome Durso said 2026 has marked significant progress as the company focuses on serious liver diseases. The company began enrolling patients in PERFORMA about three months after securing funding intended to support the program through its 52-week data readout. → SoundHound AI Sends a Loud Signal After Its Q2 Earnings Beat How Altimmune Could Grab a Big Chunk of the GLP-1 Market Chief Medical Officer Dr. Christophe Arbet-Engels said PERFORMA will be conducted at roughly 300 sites, with approximately one-third in the U.S. and two-thirds outside the U.S. Altimmune is targeting enrollment at the lower end of an estimated 18- to 24-month range for studies of this type. The company said it has sought to reduce screening failures and pathology variability through the trial design, including use of AIM-MASH AI-assisted pathology. Under the process described on the call, digitized biopsy slides will be assessed by the AI system, which will identify features and propose scores for pathologists to review. Pathologists will remain responsible for final scoring…Read full documentShow less
Interested in Altimmune, Inc.? Here are five stocks we like better. Altimmune has begun enrolling its global Phase III PERFORMA trial of pemvidutide for MASH, with about 300 sites planned and 52-week data expected in 2029. The company is using AI-assisted pathology and expects its current cash to fund the program through that readout. Phase II results for pemvidutide in alcohol use disorder showed fewer heavy drinking days, more patients reaching lower-risk or zero heavy-drinking levels, and a 9.1% placebo-adjusted weight reduction. Altimmune is preparing for an FDA end-of-Phase-II meeting and may pursue a single global Phase III trial. Altimmune completed enrollment in its Phase II RESTORE trial for alcohol-associated liver disease, with topline results expected in the second half of 2027. The company reported a $22.8 million second-quarter net loss and $519 million in cash as of June 30, but would need additional or non-dilutive financing for a potential AUD Phase III program. MarketBeat Week in Review – 11/4 - 11/8 Altimmune (NASDAQ:ALT) said it has initiated patient enrollment in its global Phase III PERFORMA trial of pemvidutide for metabolic dysfunction-associated steatohepatitis, or MASH, while advancing plans for later-stage development in alcohol use disorder, or AUD. Chairman and Chief Executive Officer Jerome Durso said 2026 has marked significant progress as the company focuses on serious liver diseases. The company began enrolling patients in PERFORMA about three months after securing funding intended to support the program through its 52-week data readout. → SoundHound AI Sends a Loud Signal After Its Q2 Earnings Beat How Altimmune Could Grab a Big Chunk of the GLP-1 Market Chief Medical Officer Dr. Christophe Arbet-Engels said PERFORMA will be conducted at roughly 300 sites, with approximately one-third in the U.S. and two-thirds outside the U.S. Altimmune is targeting enrollment at the lower end of an estimated 18- to 24-month range for studies of this type. The company said it has sought to reduce screening failures and pathology variability through the trial design, including use of AIM-MASH AI-assisted pathology. Under the process described on the call, digitized biopsy slides will be assessed by the AI system, which will identify features and propose scores for pathologists to review. Pathologists will remain responsible for final scoring under a consensus-reading process. → AST SpaceMobile Earnings Just Reminded Investors How Risky Space Can Be This Small Cap Wealth Management Stock Could Provide Big Returns Altimmune said patients using GLP-1 therapies at antidiabetic doses may be included in PERFORMA. However, patients using Rezdiffra will not be included because the company does not want to compromise the trial’s 52-week biopsy endpoint. The company also plans to characterize patients who previously did not respond to or could not tolerate GLP-1 therapies or Rezdiffra. The company expects the PERFORMA 52-week data readout in 2029. → First Solar’s Profit Engine Faces a New Policy Test in Washington Altimmune in July reported positive topline results from the Phase II RECLAIM trial in AUD. Arbet-Engels said the 2.4-milligram dose of pemvidutide met the primary endpoint by reducing heavy drinking days by 1.45 per week versus placebo at week 24. The trial also met secondary endpoints that the company said are recognized by the FDA as potential registrational measures. Roughly two-thirds of pemvidutide-treated patients achieved a two-level reduction in World Health Organization risk drinking levels, compared with about one-third of placebo patients. More than twice as many pemvidutide patients achieved zero heavy drinking days versus placebo, according to the company. Altimmune also reported statistically significant changes in abstinent drinking days, phosphatidylethanol, or PEth, levels, and body weight. The company said pemvidutide patients had a 9.1% reduction in body weight from baseline versus placebo. In an exploratory analysis among patients with a baseline FIB-4 score above 1.3, Altimmune said 50% of pemvidutide-treated patients moved below that threshold after 24 weeks, compared with 17% of placebo patients. FIB-4 is a biomarker associated with risk of liver fibrosis. The company plans to prepare a data package for an end-of-Phase-II meeting with the FDA and also expects to engage European regulators. Arbet-Engels said the company currently expects one global pivotal AUD trial could be sufficient, subject to regulatory discussions. A potential Phase III AUD program would focus on moderate-to-severe AUD, could include patients with a body mass index below 25, and may evaluate lower-dose options. Altimmune said it would likely use a 24-week primary efficacy endpoint while following patients through 52 weeks for further analyses and safety data. The company has not provided guidance on trial timing. Altimmune said it completed enrollment in the Phase II RESTORE trial in alcohol-associated liver disease, or ALD. The study enrolled about 120 patients with ALD and a history of chronic heavy drinking, and topline data are expected in the second half of 2027. The company amended the RESTORE protocol so that liver stiffness measurements will be assessed hierarchically at week 48 and then at week 24. Altimmune said the change is intended to better characterize potential liver benefits over one year and support future regulatory discussions. Management said the protocol change did not alter the study’s population or power assumptions. The company also said a separate hepatic-impairment study enabled it to broaden RESTORE eligibility for patients with higher liver stiffness measurements, after observing no added risk in that population. Altimmune reported a second-quarter net loss of $22.8 million, or $0.12 per share, compared with a net loss of $22.1 million, or $0.27 per share, in the prior-year quarter. Research and development expense was $18.7 million, up from $17.2 million a year earlier. General and administrative expense was $7.6 million, compared with $5.7 million in the prior-year period. R&D spending included $11.6 million in direct pemvidutide-development costs, including $3.8 million for MASH, $5.3 million for Phase II AUD and ALD trials, and $2.5 million for chemistry, manufacturing and controls activities. Chief Financial Officer Greg Weaver said Altimmune raised approximately $310 million year to date, including a $225 million follow-on offering in April. The company had $519 million in cash as of June 30. Weaver said the cash balance is expected to fund operations through the PERFORMA Phase III MASH 52-week readout in 2029, but does not include funding for a potential Phase III AUD trial. The company said its preference is to use non-dilutive financing for that program, potentially including royalties, debt or strategic partnerships. Altimmune, Inc is a clinical-stage biopharmaceutical company headquartered in Gaithersburg, Maryland, dedicated to the development of vaccines and immunotherapeutics. The company leverages proprietary technology platforms to create intranasal vaccine candidates and novel therapies targeting liver diseases and metabolic disorders. Altimmune's approach emphasizes the stimulation of both systemic and mucosal immune responses to address unmet medical needs in infectious and chronic conditions. Among its lead programs, NasoVAX is an investigational intranasal influenza vaccine designed to provide broad, long-lasting protection through a single, non-invasive dose. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Altimmune Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.
Investor releaseQuarter not tagged2026-08-12Altimmune, Inc. Q2 2026 Earnings Call Summary
Moby
Altimmune, Inc. Q2 2026 Earnings Call Summary
Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management is pivoting Altimmune into a late-stage company focused on a continuum of serious liver diseases, including MASH, Alcohol Use Disorder (AUD), and Alcohol-Associated Liver Disease (ALD). The initiation of the Phase III PERFORMA trial in MASH occurred just three months after securing funding, reflecting an aggressive execution strategy to capitalize on pemvidutide's balanced 1:1 glucagon/GLP-1 mechanism. Positive Phase II RECLAIM data in AUD demonstrated statistically significant reductions in heavy drinking days and met two FDA-recognized registrational endpoints, which management believes is the most robust data set in the indication to date. Strategic positioning focuses on the 'higher-risk' patient segment where AUD and liver impairment overlap, leveraging pemvidutide's dual ability to reduce alcohol cravings while providing direct metabolic benefits to the liver. Management highlighted that the AUD market has lacked innovation for 20 years, viewing the 12 million U.S. adults with moderate-to-severe AUD as a significant commercial opportunity similar to the recent evolution of the obesity market. Operational momentum is supported by high engagement from the hepatology and gastroenterology communities, who are increasingly using PEth testing to diagnose AUD within their MASH patient populations. The Phase III PERFORMA MASH trial is expected to reach its 52-week primary readout in 2029, with enrollment projected to take 18 to 24 months across approximately 300 global sites. Management plans to request an end-of-Phase II meeting with the FDA to discuss a single pivotal Phase III trial design for AUD, which may include patients with lower BMIs and explore lower dosage options. The RESTORE trial in ALD has been amended to a hierarchical analysis at 48 weeks then 24 weeks to better demonstrate long-term liver benefits (liver stiffness) to support future regulatory filings. Top-line data for the Phase II RESTORE trial in ALD is anticipated in the second half of 2027, focusing on differentiating pemvidutide from competitors that only address drinking behavior without liver-specific benefits. Financial strategy for the potential AUD Phase III trial prioritizes non-dilutive funding sources, including stra…Read full documentShow less
Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management is pivoting Altimmune into a late-stage company focused on a continuum of serious liver diseases, including MASH, Alcohol Use Disorder (AUD), and Alcohol-Associated Liver Disease (ALD). The initiation of the Phase III PERFORMA trial in MASH occurred just three months after securing funding, reflecting an aggressive execution strategy to capitalize on pemvidutide's balanced 1:1 glucagon/GLP-1 mechanism. Positive Phase II RECLAIM data in AUD demonstrated statistically significant reductions in heavy drinking days and met two FDA-recognized registrational endpoints, which management believes is the most robust data set in the indication to date. Strategic positioning focuses on the 'higher-risk' patient segment where AUD and liver impairment overlap, leveraging pemvidutide's dual ability to reduce alcohol cravings while providing direct metabolic benefits to the liver. Management highlighted that the AUD market has lacked innovation for 20 years, viewing the 12 million U.S. adults with moderate-to-severe AUD as a significant commercial opportunity similar to the recent evolution of the obesity market. Operational momentum is supported by high engagement from the hepatology and gastroenterology communities, who are increasingly using PEth testing to diagnose AUD within their MASH patient populations. The Phase III PERFORMA MASH trial is expected to reach its 52-week primary readout in 2029, with enrollment projected to take 18 to 24 months across approximately 300 global sites. Management plans to request an end-of-Phase II meeting with the FDA to discuss a single pivotal Phase III trial design for AUD, which may include patients with lower BMIs and explore lower dosage options. The RESTORE trial in ALD has been amended to a hierarchical analysis at 48 weeks then 24 weeks to better demonstrate long-term liver benefits (liver stiffness) to support future regulatory filings. Top-line data for the Phase II RESTORE trial in ALD is anticipated in the second half of 2027, focusing on differentiating pemvidutide from competitors that only address drinking behavior without liver-specific benefits. Financial strategy for the potential AUD Phase III trial prioritizes non-dilutive funding sources, including strategic partnerships, debt, or royalty financing, rather than utilizing the current $519 million cash reserve dedicated to MASH. The company reported a cash balance of $519 million as of June 30, 2026, providing a runway through the 2029 MASH readout but excluding the costs of a potential AUD Phase III program. A protocol amendment for the RESTORE ALD trial shifted the primary focus to a 48-week assessment to align with regulatory preferences for chronic disease evidence and liver benefit durability. Management noted that while GI-related adverse events led to some discontinuations in the AUD trial, the rates were comparable to placebo, where discontinuations were driven by lack of efficacy. The PERFORMA trial will utilize 'AIM-MASH Assist' AI technology to reduce pathologist variability and screen failure rates, marking the first Phase III trial to incorporate this specific digital pathology workflow. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management is targeting the lower end of the 18-24 month enrollment window by utilizing a global site footprint (1/3 U.S., 2/3 ex-U.S.) and leveraging existing CRO relationships. The trial design aims to be 'PI-friendly' by not over-burdening individual sites with high patient quotas, allowing them to participate in multiple concurrent studies. Based on recent June FDA guidance, management believes one well-controlled Phase III trial may be sufficient for approval, supported by the weight of evidence from existing pemvidutide safety data. The company intends to include both AUD-only and AUD-ALD overlap patients to demonstrate the drug's unique dual-action profile. Resmetirom will not be permitted during the PERFORMA trial to avoid confounding the 52-week biopsy results, though history of treatment failure on such drugs will be documented. Background GLP-1 use will be restricted to stable anti-diabetic doses only, ensuring the primary endpoint measures pemvidutide's specific therapeutic effect. Approximately 1/3 of AUD patients are not overweight; management intends to study this 'lean' population to secure a broad label and explore if lower doses are sufficient for patients without metabolic complications. This expansion is intended to address the full spectrum of the 27 million U.S. adults with AUD, not just those with comorbid obesity.
Investor releaseQuarter not tagged2026-08-12Altimmune Announces Second Quarter 2026 Financial Results and Business Update
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Altimmune Announces Second Quarter 2026 Financial Results and Business Update
Initiated global PERFORMA Phase 3 trial in MASH Reported positive topline data from RECLAIM Phase 2 trial in AUD Completed patient enrollment in RESTORE Phase 2 trial in ALD $519 million in cash, cash equivalents and investments as of June 30, 2026 Webcast to be held today at 8:30 a.m. ET GAITHERSBURG, Md., Aug. 12, 2026 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing pemvidutide to address serious liver diseases, today announced financial results for the second quarter ended June 30, 2026, and provided a corporate update. “We have achieved several important milestones as we continue to successfully execute our strategy, including the initiation of the PERFORMA Phase 3 MASH trial and positive topline data from the RECLAIM Phase 2 AUD trial. The team remains focused on advancing our differentiated pemvidutide franchise in both MASH and AUD, each an area of unmet need with substantial future sales potential,” said Jerry Durso, Chief Executive Officer and Chairman of the Board of Altimmune. “We are also pleased to announce completion of enrollment in the RESTORE Phase 2 ALD trial. Our momentum positions Altimmune to deliver on our goals of bringing pemvidutide to patients with serious liver diseases and creating value for shareholders.” Key Highlights and Anticipated Milestones Metabolic Dysfunction-Associated Steatohepatitis (MASH) Pemvidutide was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) based on 24-week data from the IMPACT Phase 2b trial In August 2026, the Company announced the initiation of the global PERFORMA Phase 3 MASH trial, with 52-week data readout anticipated in 2029 Alcohol Use Disorder (AUD) In July 2026, the Company reported positive topline results from the RECLAIM Phase 2 trial of pemvidutide in AUD Alcohol-associated Liver Disease (ALD) In July 2026, the Company completed patient enrollment in the RESTORE Phase 2 trial of pemvidutide in ALD Corporate Updates In April 2026, the Company completed an oversubscribed public offering of common stock, pre-funded warrants, and stock warrants, resulting in gross proceeds of $225.0 million In June 2026, the Company announced plans to relocate its corporate headquarters to Morristown, New Jersey later in 2026 Financial Results for the Three Months Ended June 30, 2026 Altimmune reported cash, cash…Read full documentShow less
Initiated global PERFORMA Phase 3 trial in MASH Reported positive topline data from RECLAIM Phase 2 trial in AUD Completed patient enrollment in RESTORE Phase 2 trial in ALD $519 million in cash, cash equivalents and investments as of June 30, 2026 Webcast to be held today at 8:30 a.m. ET GAITHERSBURG, Md., Aug. 12, 2026 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing pemvidutide to address serious liver diseases, today announced financial results for the second quarter ended June 30, 2026, and provided a corporate update. “We have achieved several important milestones as we continue to successfully execute our strategy, including the initiation of the PERFORMA Phase 3 MASH trial and positive topline data from the RECLAIM Phase 2 AUD trial. The team remains focused on advancing our differentiated pemvidutide franchise in both MASH and AUD, each an area of unmet need with substantial future sales potential,” said Jerry Durso, Chief Executive Officer and Chairman of the Board of Altimmune. “We are also pleased to announce completion of enrollment in the RESTORE Phase 2 ALD trial. Our momentum positions Altimmune to deliver on our goals of bringing pemvidutide to patients with serious liver diseases and creating value for shareholders.” Key Highlights and Anticipated Milestones Metabolic Dysfunction-Associated Steatohepatitis (MASH) Pemvidutide was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) based on 24-week data from the IMPACT Phase 2b trial In August 2026, the Company announced the initiation of the global PERFORMA Phase 3 MASH trial, with 52-week data readout anticipated in 2029 Alcohol Use Disorder (AUD) In July 2026, the Company reported positive topline results from the RECLAIM Phase 2 trial of pemvidutide in AUD Alcohol-associated Liver Disease (ALD) In July 2026, the Company completed patient enrollment in the RESTORE Phase 2 trial of pemvidutide in ALD Corporate Updates In April 2026, the Company completed an oversubscribed public offering of common stock, pre-funded warrants, and stock warrants, resulting in gross proceeds of $225.0 million In June 2026, the Company announced plans to relocate its corporate headquarters to Morristown, New Jersey later in 2026 Financial Results for the Three Months Ended June 30, 2026 Altimmune reported cash, cash equivalents and investments totaling $519 million as of June 30, 2026 Research and development (R&D) expenses were $18.7 million for the three months ended June 30, 2026, compared to $17.2 million in the same period in 2025, with the increase driven primarily by the ongoing ALD trial as well as the startup costs for the PERFORMA Phase 3 trial in MASH, partially offset by the decrease in expenses related to completion of the IMPACT Phase 2b trial in MASH, which was ongoing in 2025. R&D expenses for the quarter ended June 30, 2026, included $11.6 million in direct costs related to pemvidutide development activities General and administrative (G&A) expenses were $7.6 million for the three months ended June 30, 2026, compared to $5.7 million in the same period in 2025. The increase was driven primarily by an increase in professional services and compensation expenses in the second quarter of 2026 Interest income was $4.5 million for the three months ended June 30, 2026 Net loss for the three months ended June 30, 2026, was $22.8 million, or $0.12 net loss per share, compared to a net loss of $22.1 million, or $0.27 net loss per share, in the same period in 2025 Following the conclusion of the call, the webcast will be available for replay on the IR page of the Company’s website at www.altimmune.com. The Company has used, and intends to continue to use, the IR portion of its website as a means of disclosing material non-public information and for complying with disclosure obligations under Regulation FD. About Pemvidutide Pemvidutide is an investigational novel peptide with balanced 1:1 glucagon/GLP-1 dual receptor agonist activity that has an effect on reducing liver fat, inflammation, and fibrosis, in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD), and alcohol-associated liver disease (ALD). The activation of glucagon receptors results in direct effects on the liver, while GLP-1 receptors mediate metabolic effects such as appetite suppression and weight loss and are involved in pathways related to craving and reward. The FDA granted Fast Track designations to pemvidutide for the treatment of MASH and AUD, as well as Breakthrough Therapy Designation for MASH. In December 2025, the Company announced topline 48-week data from the IMPACT Phase 2b trial in MASH. In July 2026, the PERFORMA Phase 3 trial, a global, randomized, double-blind, placebo-controlled, parallel-group study of pemvidutide in patients with MASH was initiated. In July 2026, the Company announced positive topline results from the RECLAIM Phase 2 trial in AUD. In July 2026, the Company completed enrollment of the RESTORE Phase 2 trial in ALD. About Altimmune Altimmune is a late clinical-stage biopharmaceutical company developing therapies for patients with serious liver diseases. The Company’s lead candidate, pemvidutide, is a unique dual-action therapy targeting both glucagon and GLP-1 receptors in a balanced 1:1 ratio in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD) and alcohol-associated liver disease (ALD). For more information, please visit www.altimmune.com. Follow @Altimmune, Inc. on LinkedInFollow @AltimmuneInc on X Forward-Looking StatementsAny statements made in this press release related to the development or commercialization of pemvidutide, an investigational product candidate, and other business, regulatory and financial matters including without limitation, clinical trial study design, status, correspondence, results and data, including the ongoing PERFORMA and RESTORE trials, the timing of key milestones for the Company’s clinical programs, future plans or expectations for pemvidutide for the treatment of MASH, AUD and ALD, the potential benefits of Fast Track and Breakthrough Therapy Designations, including potential regulatory timeline and approval benefits, the Company’s financial position, and the prospects for receiving regulatory approval or commercializing or selling any product or drug candidates, financial results, and the impact of the changes to our leadership and governance structure, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to Altimmune, Inc. may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including risks relating to: delays in regulatory review, manufacturing and supply chain interruptions, access to clinical sites, enrollment, adverse effects on healthcare systems and disruption of the global economy; the reliability of the results of studies relating to human safety and possible adverse effects resulting from the administration of the Company's product candidates; the Company's ability to manufacture clinical trial materials on the timelines anticipated; and the success of future product advancements, including the success of future clinical trials. Further information on the factors and risks that could affect the Company's business, financial conditions and results of operations are contained in the Company's filings with the U.S. Securities and Exchange Commission, including under the heading "Risk Factors" in the Company's most recent annual report on Form 10-K, quarterly report on Form 10-Q and the Company’s other filings with the SEC, which are available at www.sec.gov. Investor Contact:Luis Sanay, CFAVice President, Investor [email protected] Media Contact:Real Chemistry [email protected]
TranscriptFY2026 Q22026-08-12FY2026 Q2 earnings call transcript
Earnings source - 125 paragraphs
FY2026 Q2 earnings call transcript
Good morning, ladies and gentlemen. Welcome to the Altimmune second quarter 2026 financial results conference call. At this time, all participants on a listen only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising that your hand is raised. As a reminder, this call is being recorded. I will now introduce your host for today's conference call, Luis Sanay, Vice President of Investor Relations. Luis, you may begin.
Thank you, operator, and good morning, everyone. Thank you for joining us for Altimmune's second quarter 2026 financial results and business update call. On today's call, you will hear from Jerome Durso, our Chairman and Chief Executive Officer, Dr. Christophe Arbet-Engels, Chief Medical Officer, Linda Richardson, Chief Commercial Officer, and Greg Weaver, Chief Financial Officer. Following management's prepared remarks, we will open the line for questions. Our second quarter 2026 earnings release was issued this morning and can be found in Investor Relations section of our website. Before we begin, I would like to remind everyone that remarks made about future expectations, plans, and prospects constitute forward-looking statements for the purpose of Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. Altimmune cautions that these forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those indicated.
For a review of the risk factors that could affect the company's future results and operations, we refer you to our SEC filings. I also direct you to read the forward-looking statements disclaimer in our press release issued this morning. Any statements made on this call speak only as of today's date, August 12, 2026, and the company does not undertake any obligation to update any of these forward-looking statements to reflect events or circumstances that occur on or after today's date. As a reminder, this call is being recorded and will be available for audio replay on our website. With that, I will now turn the call over to Jerry.
Good morning, everyone. Thank you for joining us today for our second quarter 2026 financial results and business update call. 2026 is proving to be a year of significant progress as Altimmune evolves into a late-stage company dedicated to serious liver diseases. We have been laser focused on execution since the beginning of the year and believe we are well positioned to advance our strategy and deliver on our mission. Pemvidutide is our foundation, and our confidence and conviction in its potential continues to strengthen with the growing body of clinical evidence. We are building momentum across our pemvidutide franchise and are excited for the future. Let me take a minute to highlight our recent progress. Starting with MASH. Last week, we announced the initiation of the PERFORMA phase III trial as we began enrolling patients in the global program.
We worked with urgency to get the trial started quickly, just 3 months after securing the financial resources to fund the study through the 52-week readout. We're very encouraged by the start of the trial. Sites are being activated quickly, and we're seeing great engagement by the medical community about what PERFORMA may mean for the MASH treatment landscape. There remains a significant unmet need in MASH. We believe pemvidutide, with its balanced one-to-one glucagon and GLP agonism in a single molecule, has the potential to offer a differentiated profile for MASH patients. Moving now to Alcohol Use Disorder, or AUD. We were pleased to report positive top-line data from the RECLAIM phase II trial last month. Pemvidutide delivered a very strong, statistically significant, and clinically meaningful reduction in heavy drinking days, which was the trial's primary endpoint.
The study also met important secondary endpoints, including a two-level reduction in WHO risk drinking levels and zero heavy drinking days. It's important to note that either of these two measures are currently accepted as FDA registrational endpoints. The totality of the top-line data from RECLAIM strengthens our conviction in pemvidutide's potential in AUD. We're moving quickly to gather the full data from the trial, then prepare the data package to request an end of phase II meeting with the FDA to discuss next steps. These compelling data, which to our knowledge are the most robust presented in AUD, further strengthens the potential of pemvidutide as a differentiated therapy across serious liver diseases.
The results from this trial are also meaningful for the AUD patient community, where pemvidutide could represent an important advancement in an area that has lacked innovation for the past two decades, and again, where a significant unmet need remains. There are approximately 12 million adults in the U.S. with moderate to severe AUD. It's well accepted that this AUD population is more likely to develop liver disease. We believe pemvidutide is uniquely positioned to benefit these higher risk patients, as its dual mechanism can address the totality of disease by reducing alcohol cravings while also providing a direct effect on the liver. This population could serve as a key commercial opportunity with substantial future sales potential. Pemvidutide has the potential to help address the continuum of liver diseases we're targeting, MASH, AUD, and ALD.
We've now delivered strong phase II data in yet another indication, and we're well on our way towards building our pemvidutide liver franchise. We're committed to executing our strategy with speed and efficiency, and the significant progress we've made this year reflects that commitment. We remain laser-focused on executing on our goal of bringing pemvidutide to patients who may benefit from its promising and differentiated therapeutic profile and creating value for our shareholders. With that, I'll turn the call over to Christophe for a clinical update.
Thank you, Jerry. I am very excited to share that we continue to advance our clinical programs across MASH, AUD, and ALD. Beginning with our program in MASH. Last week, we announced the initiation of the global PERFORMA phase III trial of pemvidutide in MASH and began enrolling patients. Over the last few months, we moved very rapidly to set up a strong and experienced global infrastructure to initiate the trial. The trial will be conducted across approximately 300 sites, with 1/3 in the U.S. and 2/3 ex-U.S. We are working closely with our CRO on site activation in multiple countries and ensuring a smooth start to the trial for an efficient enrollment. The initiation of PERFORMA is an important milestone for Altimmune and for the advancement of MASH treatment. We also see a growing interest and excitement for pemvidutide in MASH from the scientific community.
Our increased presence and engagements with the scientific community at the EASL and SOLAR medical conferences this year is driving awareness and has helped build momentum as we begin enrolling patients. Based on the strong phase II data we reported last year and the design of the PERFORMA trial, we are looking forward to studying pemvidutide in a registrational setting. Moving to AUD. In July, we were very happy to report the strongly positive top-line data from the RECLAIM phase II trial in AUD. The data readout was based on an ITT analysis as it would be for a pivotal study. The trial met its primary endpoint, where pemvidutide 2.4 milligram showed a highly statistically significant reduction in the average number of heavy drinking days versus placebo at week 24, with a treatment difference of 1.45 heavy drinking days per week.
Pemvidutide also met two critical secondary endpoints, both of which are registrational endpoints recognized by the FDA. On the first endpoint, we saw a highly statistically significant response in the two-level reduction in WHO-RDL versus placebo. Roughly two-thirds of pemvidutide patients achieved a two-level reduction in WHO-RDL versus only one-third on placebo. On the other FDA registrational endpoint of zero heavy drinking days, one that has historically been challenging to achieve, pemvidutide again showed a highly statistically significant improvement in percentage of patients with zero heavy drinking days. In this data, more than twice the number of the pemvidutide patients achieved zero heavy drinking days versus placebo patients. The trial also saw a highly statistically significant change in the percentage of days with drinking abstinence and PEth levels, which is an objective blood-based measure of recent alcohol intake over the last two to four weeks.
Pemvidutide also showed a meaningful and statistically significant reduction in body weight from baseline, with a 9.1% reduction with pemvidutide versus placebo. The totality of the data, including patients' reported measures such as the decrease in heavy drinking days, WHO-RDL reduction, and the increase in zero heavy drinking days, as well as the PEth objective measure of alcohol intake, shows strong and consistent evidence in pemvidutide's potential to address the excessive alcohol usage in AUD patients. Considering the landscape of clinical studies in AUD, including looking at other available GLP-1-AUD trials, the totality of the RECLAIM data is, to our knowledge, the most robust to date. While RECLAIM was focused on drinking behavior, we evaluated in an exploratory manner whether patients with elevated FIB-4 above the threshold of 1.3 at baseline were seeing any improvement. FIB-4 is an established biomarker correlated with risk for developing liver fibrosis.
Given pemvi's direct glucagon effect on the liver, the observed data with 50% of pemvidutide patients with a FIB-4 index above 1.3 at baseline achieving less than 1.3 after only 24 weeks, versus only 17% in placebo, is very encouraging, especially at such an early time point. We expect to further evaluate the potential liver benefit in a phase III study in AUD. In terms of safety and tolerability, pemvidutide continued to demonstrate a generally consistent safety and tolerability profile. Let me share a few thoughts as we look ahead to a potential phase III study in AUD, which of course will be subject to our dialogue with U.S. and European regulators. We would plan a phase III study in the moderate to severe AUD population. It is important to note that approximately 50% of AUD patients also have ALD.
Therefore, we would expect to study a portion of ALD patients in the AUD phase III trial. We would look to broaden the study population to also include patients with a BMI under 25 and could explore a lower dosage option. We look forward to engaging with the FDA at an end of phase II meeting and discussing a path forward for AUD. In addition, we also plan to engage with European agencies such as EMA. In ALD, we are pleased to report that we completed patient enrollment in the RESTORE trial and expect top-line data in the second half of 2027. The trial enrolled approximately 120 patients with ALD and a history of chronic and heavy drinking at baseline.
To support future regulatory discussion, we have amended the trial protocol to be able to fully demonstrate the liver benefits in the ALD population that pemvidutide may provide at one year. The primary endpoint of the trial, the change from baseline in liver stiffness measurements, or LSM, will now be assessed in a hierarchical manner at week 48 and then at week 24, allowing for both time points to be assessed. The RESTORE trial is now designed to show a liver benefit over a long period of time, and this is consistent with our development strategy of focusing on higher risk patients. Demonstrating a liver benefit over a long period of time could be a key differentiator for pemvidutide versus other AUD therapies in development, because AUD patients are often already presenting some level of liver impairment.
In summary, we are very encouraged by the progress we are making as we move closer to delivering on our mission of helping the millions of patients with serious liver disease. I will turn the call to Linda.
Thanks, Christophe, and good morning, everyone. In recent quarters, I have shared insights from our market research describing how pemvidutide's target product profile positions us well for future competitiveness in the MASH market. Today, I will focus on how we view the current alcohol use disorder market landscape, how we believe this will evolve in the future, and the potential role of pemvidutide in driving this evolution for patients and healthcare providers. First, the AUD market has considerable untapped potential. Alcohol use disorder is one of the largest under-addressed markets in the U.S. Approximately 27 million adults meet the criteria for AUD, 12 million of whom are considered to have moderate or severe AUD. It is this group that has the highest risk of progressing to subsequent liver damage, and we believe pemvidutide potentially would bring the most benefit.
Overall, only 10% of AUD patients are diagnosed, and of those, only one in four receives drug therapy. It is well known that excessive drinking has direct negative impacts on the liver, including cirrhosis, liver failure, and even death. In fact, excessive alcohol consumption is one of the leading causes of preventable liver injury worldwide. The low diagnosis and treatment rates for AUD seem to represent a bit of a disconnect, given these health consequences. Why is this? Patient concerns about being stigmatized, low awareness of available drug therapies, less than ideal treatment options with poor compliance that limit prescribing, and no recent therapeutic innovations all contribute to the low diagnosis and treatment rates. There is a clear opportunity for future therapies with new mechanisms and better efficacy and tolerability to help address this dynamic. In fact, there has not been a new drug approved to address AUD in 20 years.
Better solutions often bring renewed interest and growth to therapeutic categories that have been relatively stagnant, as was the case with obesity. We believe strongly that pemvidutide may bring exactly this type of innovation to the AUD market, particularly for moderate and severe patients. The unmet need in the AUD market demands new treatment solutions. The RECLAIM phase II efficacy and tolerability data show pemvidutide's balanced one-to-one glucagon GLP-1 activity significantly improved multiple measures of excess drinking and may show positive effects on underlying or subclinical liver impairment in future studies. The potential direct liver benefits that pemvidutide may demonstrate in AUD would provide a strong impetus to prescribe in the moderate and severe patient segments, beyond the decrease in drinking levels and behavior. Other products in development may not demonstrate this liver benefit, concentrating more on the cravings and behaviors associated with AUD.
Additionally, current AASLD treatment guidelines for MASH strongly encourage alcohol screening, as alcohol consumption accelerates the progression of metabolic dysfunction and increases the risk of liver decompensation, negatively impacting patient outcomes. We see a potential dynamic emerging where increased alcohol screening and routine PEth testing among liver specialists could substantially increase the diagnosis of AUD even while assessing MASH patients. Recent market research we conducted shows that 44% of hepatologists and 27% of gastroenterologists reported they already use PEth testing in their MASH patients.
There is considerable overlap among MASH, AUD, and ALD populations, highlighting the increasing role that the hepatology and gastro communities may play in managing these patients who have or are at risk for serious liver diseases. In summary, the AUD market of today will not be the AUD market of the future. We believe pemvidutide is well-positioned to potentially disrupt this category, providing a catalyst that sets new expectations for what drug therapy can accomplish in the moderate or severe AUD patients who are most at risk for liver damage. We look forward to generating additional clinical data to support these beliefs and to share insights from our pre-commercial work along the way. With that, I will turn it over to Greg for the financial review.
Thank you, Linda, and good morning. Starting with our financial results for the quarter, which were in line with our expectations. R&D expense in Q2 2026 was $18.7 million, compared to $17.2 million for the same period prior year. The increase in R&D spend was driven by investment into our ALD trial, as well as start-up costs for the phase III trial in MASH, offset by a decrease in expenses related to the completion of the phase II trial in MASH, which was ongoing in 2025. Q2 2026 R&D spend included $11.6 million of direct costs related to pemvidutide development, of which $3.8 million was for MASH, $5.3 million for the phase II AUD and ALD trials, and $2.5 million in CMC related expenses. Q2 2026 R&D also included $1.1 million in non-cash stock compensation.
G&A expenses in Q2 2026 were $7.6 million, compared to $5.7 million for the same period prior year. The increase in G&A was driven by an increase in professional fees and compensation expenses. The Q2 2026 G&A included $1.7 million in non-cash stock comp. Net loss for the second quarter of 2026 was $22.8 million, or $0.12 a share, compared to a net loss of $22.1 million or $0.27 a share in the second quarter of 2025. Now moving to the balance sheet. Since the beginning of the year, we strengthened our financial position, having raised approximately $310 million year-to-date, including the $225 million follow-on offering in April. June 30, 2026, total cash was $519 million. This cash position provides us with the operating cash runway through the PERFORMA phase III MASH 52-week data readout, which is expected in 2029.
While our cash runway forecast fully funds the company through the MASH phase III 52-week readout, it does not include a potential phase III trial in AUD. As we have previously noted, our plan and preference is to use non-dilutive means to fund that trial when needed, and on the strength of this data, we believe we will have the options to fund that trial, which could include royalty, debt, and/or strategic partnerships. With feedback from regulatory authorities, we will determine the scope and level of investment required for a phase III trial in AUD, and we will provide the Street with an update as appropriate.
Thank you very much. That concludes our prepared remarks, and we will now turn the call back to the operator for the Q&A session. Operator?
Thank you. Ladies and gentlemen, if you would like to ask a question at this time, you will need to press star one one on your touchtone telephone and wait for your name to be announced. To withdraw your question, simply press star one one again. Please stand by while we compile the Q&A roster. Our first question coming from the line of Thomas Smith with Leerink Partners. Your line is now open.
Hey, guys. Good morning. Congrats on all the progress.
Good morning, Tom.
Thanks for taking our questions.
Good morning.
On the phase III PERFORMA study, I 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 III programs at various stages of enrollment. I was hoping you could provide a bit more detail on how you are targeting study sites with respect to competing programs. How much overlap is there with some of these ongoing pivotal programs? Maybe if you could talk about your expectations on patient enrollment relative to some of the other phase III programs for sema or survodutide or the FGF21s. Then I have a follow-up if I could.
Okay. Thanks, Thomas. First of all, as we said in the prepared remarks, we are really encouraged by the speed at which we have been able to initiate and the work happening on the ground that Christophe can give you a little color on. We are operating in an environment where there are some other studies going on, which I think we have been able to work through and take advantage of, frankly, some of the experience out there, both on the CRO side and on the site side as we think about the speed at which we want to enroll. Christophe?
Yeah. We have planned to have a number of sites, as we said, in the range of 290, 300 sites around the world. We are well aware of the competitive nature of such trials. What we have built on is the number of factors that are attractive for our study, including the AIM-MASH, the design where we can reduce the screen failures, and also our relationship with the sites, either through our experience in the phase II or through our CRO right now. We also have not
expanded the number of patients that we are asking each of those sites to a reasonable number so that they are able to do additional study as well. Those different features in our consideration for enrollments are really pleasing, I should say, the PIs and the investigators to this point. We were able to get a really good response on this. Our enrollment is around, for studies in that nature, between 18 to 24 months. We are, because of these different aspects that we heard they are very attractive for the PIs, we are aiming at the lower end of this, and that fits well with what we are hearing right now.
Got it. That makes sense. A follow-up, if I could, on the RESTORE study in ALD. Could you just elaborate a bit more on the rationale for the protocol amendment and using this hierarchical analysis looking at the 48-week time point before the 24-week time point? Can you comment a bit more on the powering assumptions and what impact the protocol amendment might have on those assumptions? Thanks so much.
Sure. It doesn't impact any. This is no change at all on the protocol for this. It's a statistical feature from the AUD data and what we've seen and the benefits we expect from pemvidutide on the liver. For future filing, and regulatory filing, we are interested in better characterizing this aspect into the ALD study. What we're going to be doing is reading at 48 weeks. There is no alpha spending or anything like this with that hierarchical. We were collecting those data anyway. What we're just doing is now being able to analyze both aspects at week 48 and at week 24 in a powered manner using that statistical approach. It's strengthened, if you wish, the role of this study in our differentiation on the liver benefits.
As we indicated in the prepared remarks, Linda went into some detail. We think about the AUD population with the moderate to severe patients. There is, we know, a significant overlap with AUD and ALD in that population. Having a 12-month view around the liver benefit fits consistently with where we see the differentiation of pemvidutide in an area of high unmet need. Thanks, Thomas.
Thank you. Our next question in queue coming from the line of Michael DiFiore with Evercore ISI. Your line is now open.
Good morning. Thanks so much for taking my questions, guys. A few from me. For AUD, is conducting one global pivotal trial still the base case now that you're incorporating both FDA and EU requirements? I have a follow-up or two. Thanks.
Yes. Given the recent guidance, the June guidance from the FDA, we expect that one trial will be sufficient. That guidance talked about the weight of evidence and the quality of the biomarkers. We know that, for example, PEth is becoming more important. We have those PRO, the WHO-RDL, and the zero heavy drinking days that are validated. Our approach is to go with one single trial and to be able to use also our additional experience with pemvidutide in other population for our safety database. All together, we believe that one pivotal Phase III in AUD, and potentially ALD patient as well, will be the best approach, and we have some synergies between our different programs.
Of course, we'll have the expected discussions with the regulators both in the U.S. and in Europe as we move forward and try to narrow down the assumptions around what Phase III is going to look like.
Got it. Very helpful. Two follow-ups, if I may. On the RECLAIM call, you were still analyzing the timing of the drug-related discontinuations. Now that some time's passed, do you know whether they clustered around either dose escalation step? Separately, back in March, you said you were active on ex-U.S. partnering, and you since generated the positive AUD data. My question is, has the level of strategic interest changed meaningfully since RECLAIM? Thank you.
I'll start on that one, and then Christophe can take the second one. I think we've maintained, Michael, as you know, that we're active and open on the front of exploring how best to accelerate and fund the program globally. We continue to maintain the openness and activity on that. We do believe that with this data set in AUD, the potential of pemvidutide has increased. We take that into the discussions appropriately with strategics.
Right. With regard to the discontinuation rates, we are still looking in more details at those data. The discontinuation rate overall was fairly similar between placebo and the active arm. It was more related to GI AEs. In the placebo effect, it was to lack of efficacy. This is pretty consistent with what is expected, but we'll have more of the details of every single aspect of this in the weeks to come. We're still looking into our final programming, et cetera, to get those data.
Great. Thanks so much.
Thank you.
Thank you.
Thanks, Michael.
Our next question coming from the line of Roger Song with Jefferies. Your line is now open.
Hi, guys. This is Peter on for Roger. Congrats on the progress and thanks for taking our question. Two from us. Do you plan to share any subgroup analyses from the RECLAIM-AUD trial? Are there any patient segments where efficacy appears particularly compelling? Second, could you share any additional detail on how you're thinking about phase III timing, trial design, and funding? Thank you.
Sure. On the sub-analysis, yes. We'll be continuing to dig into our data and look at this. We'll present these data at future medical conferences, and so we will have additional information around this. On the phase III, I shared a little bit in the prepared remarks some of our thoughts right now. I think importantly, again, we are gaining more and more information around the benefits on the liver side. We want to really establish this in our phase III, given the overlap between our AUD, ALD population. That's going to be a real factor here that we're going to look into. Also broaden the population a little bit on the BMI sides, given that our phase II had that limitation. So we're looking at a study that's probably, given the current guidance, having a 24-week primary efficacy endpoint.
We want to look also probably further to get all the way to 52 weeks with regard to additional analysis. We'll give more details as we are building this and as we're getting feedback from the regulators.
Yeah, on the question of timing, look, we're not yet guiding on timing. We're really encouraged by the data. We're going to work quickly and thoroughly on compiling the full data set to answer some of the questions, even that have come across this morning. We'll look to package that in a submission to the agencies for an end of phase II, and we'll update you accordingly as you would expect around specific timing. Importantly, the AUD data really creates the opportunity for a liver franchise here. I think you heard this morning, and you'll continue to hear from us about where we see the differentiation not only in MASH but in AUD and really the dual mechanism and the opportunity to impact drinking and impact the liver.
Kind of helps us focus on a group of higher risk patients where we think the benefit of pemvidutide can be unique and different from the other drugs that are potentially available or the ones you know of in development now.
Great. Thank you.
Thanks, Peter.
Thank you. Our next question coming from the line of Eliana Merle with Barclays. Your line is now open.
Hey, guys. Thanks for taking the question. Curious your thoughts on how you're thinking about the placebo rate in your MASH phase III study, and can you remind us what your design allows in terms of GLP-1 use at baseline and throughout the study? Just a second question, what would be good data from the phase II ALD study on liver stiffness next year? Thank you.
Okay, great.
Yes.
Hard on MASH.
On the placebo, we've built some aspects with regard to, for example, the AIM-MASH to decrease variability, to decrease the training of pathologists, et cetera. We are reading at 52 weeks. We think that for the MASH study, that analysis for the accelerated approval will give us what we are expecting with regard to the anti-fibrotic effects that we're seeing. The GLP-1 use is accepted in our study, the antidiabetic doses. We will include also diabetic patients in that particular study, as long as they are on GLP-1 or other therapies that are limited to their antidiabetic doses. Then I think you had a question on the. I'm blinking.
ALD.
ALD expectations on the ALD data.
What would be good on the ALD? Well, we are looking forward to see, and we believe that exactly by now being able to read both at 48 weeks and 24 weeks, that we will be able to clearly characterize the liver benefit effect of pemvidutide through this longer treatment all the way to one year duration, and this will be very helpful in our discussions with regulators. So a study that would deliver this would be obviously a very positive study for us.
Remember, in that study, we are also capturing all the expected impact of reduced drinking, which I think when we look at the population in that ALD study, we know at baseline heavy drinking ongoing. So again, just reinforcing that overlap that exists between AUD and ALD.
Great. Thanks.
Thanks, Eliana.
Thank you. Our next question coming from the line of Srikripa Devarakonda with Truist Securities. Your line is now open.
Hey guys, thank you so much for taking my question, and congratulations on the progress this quarter. I have a couple of questions. One is on AUD. Can you remind us what percentage of AUD patients are overweight or obese, and how this might play into your phase III planning? Does it make sense to focus on demonstrating dual benefit of weight loss and drinking reduction to appeal to payers? Also, if I heard it correctly, you plan to have a cohort based on BMI less than 25. Going back to the MASH study, that is my second question. Do you have any MRI DEXA sub-studies in PERFORMA to support a specific lean mass preservation, which is something that you have shown in your phase II study claim on the label, or is this mainly something that you would use for messaging, assuming the drug is approved? Thank you.
I will try to tick them off here, Kripa, because you gave us a bunch.
Sure.
First on PERFORMA.
I can go back to the questions.
Yeah. First, I was writing quickly, but thanks. First, on PERFORMA, as we've said before, we are doing work as part of the overall program, which will allow us to better characterize some of the impact on body composition in the MASH population. Again, we think doing that as part of the phase III might give us some opportunity on the labeling side if everything goes in the direction. Maybe Linda, you can comment on some of the concomitancy. I think the question around the overweight and obesity. You did hear Christophe correctly. We do anticipate including patients in a potential phase III on AUD that were below the 25 BMI, and that will be part of the construction of the trial and the dialogue. Linda, maybe you want to talk about the concomitancy.
Yeah. I think depending on the source, you see upwards to practically two-thirds of patients having overweight, not necessarily obesity, but a combination of those. So a safe assumption is at least half, because we know what the rates are in the general population, and we see that drinking can contribute to excess weight. There's also obviously in some of the more severe populations, particularly in ALD, they actually have some lean drinking. They have caloric restriction issues because they're drinking and have other issues. But the benefits, and we talked to some preliminary market access payer work. The losing of weight can be helpful to them as a sign, but really the reductions in drinking and the impact on the liver and the potential to address that.
Here you have something that not only is, in pemvidutide, something that is not only addressing the cause of the issue, but the damage to the liver potentially, and that's what we're really interested in exploring on that back end, hence the discussion on the ALD timelines and where we're looking at a 48-week readout. All of these things that differentiate us make us highly relevant to the population that needs the most help. That's really where we're focusing on that idea, because there's never been something that really is doing both in the AUD population. That is really resonating with, I would say, patients, prescribers, and payers.
I think that's why we view the AUD data set we just reported out as so robust and de-risking. Because we get clarity across all of the endpoints, including the two approvable endpoints. We have a clear impact at 24 weeks on drinking across those, on weight in a population where, again, the two-thirds of them are overweight or obese, and the signals on the liver, which we'll explore more deeply in phase III. So we think we're in a good position to understand what pemvidutide can really bring in uniquely in this high-risk segment.
Great. Thanks for getting all of them. Thanks a lot.
Thanks, Kripa.
Thank you. Our next question coming from the line of Annabel Samimy with Stifel. You will remain on the line.
Hi, thanks for taking my question. I am curious about the follow-up from the AUD study. I think it is pretty well known that with the weight loss drugs, there is rebound when patients stop taking the injections, and there are persistence problems. 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? Is there any work being done in trying to maintain a persistence of treatment on these drugs? Have you noticed anything with any of the other incretins where they have removed treatment and then there is rebound in the alcohol use? Just one question on that, and then if you can just give us some clarity on the powering assumptions for ALD. Thank you.
Let me start on what the competitive context is with rebound. What has happened more often is that patients cannot tolerate those therapies and are falling off. That is a major issue and part of the reason that you saw an injectable come out with VIVITROL to try and get compliance and staying on drug to help give the most benefit. That still is an unmet need. Again, when you reflect on the tolerability overall that we have seen with pemvidutide, we believe that that also positions us very well as we study in various therapeutic areas here. We think that that is an advantage for us. In terms of, I think following up on our own study results, I think we have not had a chance even to do that.
I will defer to Christophe to look at that because I know we have not looked at all the data sets yet.
Exactly, Linda, thanks. The study was not designed to look at a formal assessment of rebound. We have a follow-up period that we're going to get some information. We'll look into that. I think, again, to the point Linda made, having a drug that people can take chronically, take on the long term. I think even the guidance from the FDA relates to the fact that this is a chronic disease. This is not just a temporary disease, and the treatment needs to be evaluated chronically, bodes well with the safety and tolerability that we have seen with pemvidutide. This is something we'll be able to look a little further in our phase III and over longer duration. With regard to power assumptions for ALD, we will power the study north of 90%. A single trial needs to be powered like this.
We will have, like we discussed, the typical AUD with already some damage in the liver, whether they know it or not, similar to what we've seen in our phase II, and we'll have also ALD population, and we'll make sure that this is powered adequately. We'll have those discussions with the regulators, and we'll be able to design the study so that it supports the indication for these populations.
Great. Thank you.
Thank you.
Thank you. Our next question coming from the line of Catherine Okoukoni with Citizens, your line is now open.
Starting the phase III programs in AUD especially, considering it is not fully funded while leveraging the ongoing phase III MASH trial. When would you decide to allocate additional funds, and what would you need to see to do that?
Hey, maybe Greg, you can jump in, I think. I am sorry, you cut out a little bit on our end, but I believe the question is around how we are thinking about financing on the AUD side.
Yeah, thanks. Greg here, and I appreciate the question. This strength of this phase II data in AUD presents us with an opportunity for phase III. Next steps, as was teased out earlier in the call, will be feedback from FDA in the phase II meeting. That will allow us then to step back and just sketch out and design the blueprint for the size and scope of that phase III, costing that out. Clearly anticipate that will be quite a bit less costly than a MASH phase III would be. With that design, would then be in a position to finance that in the new year and anticipate that the preference would continue to be for non-dilutive funding. Those options could include a combination of strategic monies and/or debt or royalty, et cetera. Again, highly confident that that is a program that is fundable.
And again, just to remind, we reported June 30, cash $518 million. That is runway through the MASH phase III readout top line in 2029. So again, takeaway message there is a strong balance sheet today. Great opportunities for the second great indication and a second phase III to build out the franchise.
Thank you. Our next question in queue coming from the line of Patrick Trucchio with H.C. Wainwright. Your line is now open.
Thanks. Good morning. 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 II RECLAIM trial in 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 am wondering if you are going to be allowing background GLP-1 therapy, RYBELSUS or other glucose-corrected therapies, and how you could manage patients who want to initiate or resume those therapies during the 52-week biopsy period. And then just lastly, can you detail a bit more about AIM-MASH, exactly how AIM-MASH AI assist will be incorporated into the pathology workflow and just sort of the operational metrics around this?
Sure. Yeah. So to the first point on the titration and the learnings from the AUD trial for the 2.4 milligram, yes, we have learned that in that particular population, the monthly titration is a simple step, that is a couple of steps, and it is favorable with regard to, in particular, nausea and vomiting. So I think the direction is very supportive to move for the 2.4, and we will have a one step for going to the 1.8 milligram and the two steps to go to the 2.4. So very simple, easy titration. So those are consistent learnings from the AUD trials applying into the PERFORMA phase III. With regard to GLP-1 and as mentioned, or REZDIFRA. As mentioned before, the GLP-1 will be tolerated only at antidiabetic levels.
The Rezdiffra will not be included in the trial in order to not jeopardize our primary endpoint with regard to the 52 weeks readouts on the biopsy. We will collect history of patients that do have failure on GLP-1, Rezdiffra, et cetera, who have not improved and not tolerated this. We will be able to characterize the population and understand which were, I would call treatment failures for those particular therapies. With regard to the AIM-MASH assist, the way it works is basically the slides that are taken from the biopsy are stained, and then they are digitalized. The program on the AIM-MASH assist will point to the features based on that AI system, propose a score, and the pathologist will be able to look at those and agree or disagree with the scoring or with the evaluation on certain aspects.
Given it is a consensus reading at the end as per the FDA requirement, the pathologists are responsible for the scoring. PathAI claims that it improves variability and improve consistency between pathologists. We have already put in place additional aspects to make sure that we have that consistency between training, harmonization, and using charters and alignment on how to read the slides. All these feature, we hope, will decrease any variability, improve consistency in the reading, and help, not only in the enrollment phase to decrease the screen fail patients, but also in the efficacy reading to have less variability around the reading. Put together, this is the first, again, PERFORMA is the first phase III trial with the AIM-MASH assist. There is quite a lot of actually excitement around this from the sites, as we have heard.
Just on the RECLAIM, if I can add a few additional follow-ups. Just in terms of durability of the AUD effect, do you have any sense of whether the treatment effect was early and durable? Will you eventually have this data? On the phase III endpoint selection, or would you eventually share that data? On the phase III endpoint selection, I think you noted that two level World Health Organization risk drinking level reduction, zero heavy drinking days are the FDA recognized registrational endpoints. Which one, or is there a preferred primary endpoint, and would heavy drinking days be supportive or primary? Just lastly, on the AUD phase III population, you mentioned broadening the phase III AUD population to include BMI below 25 and potentially lower dose options.
What is the rationale for those changes, and would the phase III trial include both AUD only and AUD/ALD overlap patients? Thank you.
On the durability of the AUD, we have some elements in our data that show that there was no plateau of the effect after 24 weeks. Clearly we're going to continue to explore this in the phase III, which will go all the way through 52 weeks, and is needed anyway for the safety database. We'll have that information, but it is expected, for example, even on the weight loss and other aspects on the path, on the number of abstinent days, for example, to continue improving these patients and the chronic exposure to pemvidutide is really important to assess. On the phase III endpoints, we are lucky enough in our RECLAIM study to have a validation of both. Obviously, we're powering, we are going to select one and align with the regulators. Keep in mind that very often the regulators will look at both.
We have also the options to power fully for both, more likely into one primary endpoint, one key secondary endpoint, something in that nature in the way to look at it. But the zero heavy drinking days or the WHO-RDL will be the endpoint that we'll be clearly looking at. And the population with regard to lower dosing or extending to BMI below 25, as Linda said, originally there's two thirds of the population that are overweight and have AUD. There's an overlap between these two aspects. But there's also another third that is not overweight. We believe we can address that population by doing this. These patients may require less exposure or the current 2.4 could be very efficacious. But in some patients, a lower dose could be sufficient. We need to evaluate this during our phase III.
We believe a couple of doses will be something, an approach that will allow us to better characterize how to distinguish in this different population and having a broad picture with all the details that we need when we discuss with the regulators for that filing.
Terrific. Thanks so much.
Thank you.
Thanks.
Thank you. Our next question coming from the line of William Wood with B. Riley Securities. Your line is now open.
Hi. Yes, thanks for taking our questions. Looking back over the past year and the changes in some of the ALD inclusion requirements, it looks like you have increased your liver stiffness that you are allowing into the trial from about 18.5 up to about 25. I was wondering if you could speak to how you expect that, or why that change may have been occurring, 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. I know you said that you were going to be evaluating both, but it does seem to be semi-hierarchical.
A follow-up question or secondary question, at least for your AUD trial, I know we are expecting, I believe, bimagrumab will be reading out in 2028, which obviously has the GIP 1. I was just curious how we should be thinking about, at least in drinking reduction, the differences that may occur with GIP versus a glucagon component added on. Thanks.
Yep. I will start on the LSM, on the liver stiffness criteria, inclusion criteria. These are not related at all to the change in reading of primary endpoint at week 48 with the hierarchical procedure. The hierarchical procedure, as I mentioned, is directly focused on strengthening our understanding of pemvidutide's beneficial effect on the liver and supporting further discussions with the regulator. The criteria and the amendment that we have had was actually related to a study that we have made as a hepatic impairment study that allowed us to now expand to those patients and broaden that criteria. As you can imagine, every time we do developments, we have a number of learnings, and we were able to implement the learnings from the hepatic impairment study that did not show any risk in the population, and we were able to expand and broaden the criteria.
With regard to the AUD and the bimagrumab, we are looking forward to see this data. I think, again, bimagrumab is a GLP-1 GIP. It does not have the liver effect, so it is probably similar to what you see with GLP-1, semaglutide, things to that extent, maybe a little different because of the GIP component. But the direct liver impact, we believe, is important. We have heard from our KOL that it is really, for them, what they call a game-changing approach if you are able to treat the patients that have AUD and may not even know they already have liver steatosis, inflammations, or be even having fibrosis. So pemvidutide fits really well in that population, and that is what we want to build on.
Yeah, I think that
Thanks
they are also looking at earlier patients, the mild segment.
Yep.
Thanks for the question. Operator, are there any more?
Yes, we have one more question in queue. Last questioner will come from the line of Andy Hsieh with William Blair. Your line is now open.
Oh, great. Thanks for squeezing me in. Maybe one more on the RESTORE study and about liver stiffness. The upper end of that range, 10-25. The upper range is suggestive of cirrhotic features for these patients. I am curious if the data is supportive in that segment, and how would you use that data, potential read-throughs to other indications, basically generating more data for pemvidutide in the cirrhotic patient population. Thank you.
Thank you for the question. On the liver stiffness, as you know, the range, there is a little bit of variability there. You are correct, we may include a very small or minor population of patients that are a little more advanced, closer to the cirrhotic stage. We know the drug is safe because we have done the hepatic impairment, as mentioned before. We know that in this population, we are going to be okay. I think we will have the opportunity to include those patients in our phase III and look at the AUD. In the meantime, it is important. Again, one piece that in this population is happening is over a certain period of time, from a regulatory perspective, it will be important to show that even if patients advance or if they are worsening, we can address this population.
That will be something that the regulator will be looking at, and we will be happy to provide that information based on those approach or inclusion criteria.
That is helpful. Thank you.
Thanks.
Thank you. That is all the time we have for our Q&A session. I will now turn the call back over to Mr. Jerome Durso for any closing comments.
Thanks, operator, and thanks everybody for joining us today. From our standpoint, we feel very positive about the progress we have made, significant progress to date. I think we are clear on the work to do ahead of us and definitely committed to continuing to advance what we believe to be a promising, meaningful, differentiated therapy in pemvidutide for serious liver conditions. Moving forward, it is going to be an exciting time. I will continue to update you on the progress moving forward, and enjoy the rest of the day, and have a great last of your summer. Take care.
This concludes today's conference call. Thank you for your participation. You may now disconnect.
Investor releaseQuarter not tagged2026-08-07PBYI Q2 Earnings & Sales Beat Estimates, 2026 Guidance Raised
Zacks
PBYI Q2 Earnings & Sales Beat Estimates, 2026 Guidance Raised
Puma Biotechnology PBYI reported second-quarter 2026 adjusted earnings of 19 cents per share, beating the Zacks Consensus Estimate of 10 cents. In the year-ago quarter, the company had reported adjusted earnings of 15 cents per share. Total revenues for the quarter were $56.5 million, which beat the Zacks Consensus Estimate of $53 million. Revenues increased 7.8% year over year, driven by higher net product sales. Total revenues comprised net product sales of Nerlynx (neratinib), PBYI’s only marketed drug in the United States, and royalty revenues. Nerlynx is indicated for the treatment of early-stage HER2-positive breast cancer. Year to date, shares of Puma Biotechnology have rallied 36.5% compared with the industry’s 4.4% growth. Image Source: Zacks Investment Research Product revenues from Nerlynx totaled $53.6 million in the second quarter, up about 9% year over year. This metric beat our model estimate of $50.9 million. Royalty revenues declined 9.4% year over year to $2.9 million. Selling, general and administrative (SG&A) expenses (excluding stock-based compensation expense) declined 4.1% year over year to $16.3 million. Research and development (R&D) expenses (excluding stock-based compensation expense) totaled $18.2 million, up 22.1% year over year, reflecting higher costs associated with clinical studies on alisertib along with higher internal R&D expenses. As of June 30, 2026, PBYI had cash, cash equivalents, restricted cash and investment securities of $93.9 million compared with $101.5 million as of March 31, 2026. Puma Biotechnology raised its financial guidance for 2026. For full-year 2026, total revenues are expected to be in the range of $224-$231 million compared with the previous projection of $222-$229 million. The Zacks Consensus Estimate for the metric is pegged at $224.5 million. Net product revenues are projected to be in the range of $205-$209 million versus the earlier expectation of $202-$206 million. Meanwhile, royalty revenues are expected to be to range from $19 million to $22 million, down from the previous expectation of $20–$23 million. The company expects to generate net income of $17-$20 million compared with the earlier projection of $16-$19 million for 2026. For the third quarter of 2026, the company expects net product revenues to be between $54 million and $56 million and royalty revenues in the range of $2 million to $…Read full documentShow less
Puma Biotechnology PBYI reported second-quarter 2026 adjusted earnings of 19 cents per share, beating the Zacks Consensus Estimate of 10 cents. In the year-ago quarter, the company had reported adjusted earnings of 15 cents per share. Total revenues for the quarter were $56.5 million, which beat the Zacks Consensus Estimate of $53 million. Revenues increased 7.8% year over year, driven by higher net product sales. Total revenues comprised net product sales of Nerlynx (neratinib), PBYI’s only marketed drug in the United States, and royalty revenues. Nerlynx is indicated for the treatment of early-stage HER2-positive breast cancer. Year to date, shares of Puma Biotechnology have rallied 36.5% compared with the industry’s 4.4% growth. Image Source: Zacks Investment Research Product revenues from Nerlynx totaled $53.6 million in the second quarter, up about 9% year over year. This metric beat our model estimate of $50.9 million. Royalty revenues declined 9.4% year over year to $2.9 million. Selling, general and administrative (SG&A) expenses (excluding stock-based compensation expense) declined 4.1% year over year to $16.3 million. Research and development (R&D) expenses (excluding stock-based compensation expense) totaled $18.2 million, up 22.1% year over year, reflecting higher costs associated with clinical studies on alisertib along with higher internal R&D expenses. As of June 30, 2026, PBYI had cash, cash equivalents, restricted cash and investment securities of $93.9 million compared with $101.5 million as of March 31, 2026. Puma Biotechnology raised its financial guidance for 2026. For full-year 2026, total revenues are expected to be in the range of $224-$231 million compared with the previous projection of $222-$229 million. The Zacks Consensus Estimate for the metric is pegged at $224.5 million. Net product revenues are projected to be in the range of $205-$209 million versus the earlier expectation of $202-$206 million. Meanwhile, royalty revenues are expected to be to range from $19 million to $22 million, down from the previous expectation of $20–$23 million. The company expects to generate net income of $17-$20 million compared with the earlier projection of $16-$19 million for 2026. For the third quarter of 2026, the company expects net product revenues to be between $54 million and $56 million and royalty revenues in the range of $2 million to $3 million. Total revenues are expected to be between $56 million and $59 million. The company anticipates reporting a net income of approximately $2 million to $3.5 million for the quarter. Puma Biotechnology in-licensed global development and commercialization rights to alisertib, an aurora kinase A inhibitor, from Japan’s Takeda in 2022. It is developing alisertib for hormone receptor-positive breast cancer as well as small-cell lung cancer (SCLC). The company is conducting a phase II ALISCA-Breast1 study on alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer. Updated data from the study are expected in the fourth quarter of 2026. PBYI is conducting ALISCA-Lung1, a phase II study evaluating alisertib as a monotherapy for the treatment of patients with extensive-stage SCLC. The company plans to expand enrollment in both these studies in the second half of 2026. Puma Biotechnology plans to initiate enrollment in the phase I/II ALISCA-Lung2 study of alisertib in combination with paclitaxel for the treatment of patients with extensive-stage SCLC in the third quarter of 2026. Puma Biotechnology, Inc. price-consensus-eps-surprise-chart | Puma Biotechnology, Inc. Quote Puma Biotechnology currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Harmony Biosciences HRMY and Liquidia Corporation LQDA, each currently sporting a Zacks Rank #1 (Strong Buy) and Altimmune ALT, which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, earnings per share estimates for Harmony Biosciences have increased from $3.20 to $3.33 for 2026. Over the same period, estimates for earnings per share increased from $3.64 to $3.92 for 2027. HRMY shares have risen 3.5% year to date. Harmony Biosciences missed on earnings in three of the trailing four quarters and beat in the remaining one, delivering an average negative surprise of 13.97%. Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have increased to $3.02 from $2.97. Over the same period, EPS estimates for 2027 have risen to $5.31 from $4.81. LQDA shares have gained 159.3% year to date. Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%. Over the past 60 days, estimates for Altimmune’s 2026 loss per share have narrowed from 69 cents to 64 cents. Over the same period, loss estimates for 2027 have also improved from 73 cents to 64 cents. ALT shares have declined 16.7% year to date. Altimmune’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 15.81%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Puma Biotechnology, Inc. (PBYI) : Free Stock Analysis Report Altimmune, Inc. (ALT) : Free Stock Analysis Report Liquidia Corporation (LQDA) : Free Stock Analysis Report Harmony Biosciences Holdings, Inc. (HRMY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2026-08-05Altimmune to Report Second Quarter 2026 Financial Results and Provide Business Update on August 12, 2026
GlobeNewswire
Altimmune to Report Second Quarter 2026 Financial Results and Provide Business Update on August 12, 2026
GAITHERSBURG, Md., Aug. 05, 2026 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing pemvidutide to address serious liver diseases, today announced that it will report its second quarter 2026 financial results on Wednesday, August 12, 2026. Altimmune management will host a conference call at 8:30 a.m. ET on August 12 to discuss the financial results and provide a business update. The conference call will be webcast live on Altimmune’s Investor Relations website. Participants who would like to join the call may register here to receive dial-in numbers and a unique PIN. A replay will be available on the Investor Relations website shortly after the call for up to three months. About Altimmune Altimmune is a late clinical-stage biopharmaceutical company developing therapies for patients with serious liver diseases. The Company’s lead candidate, pemvidutide, is a unique dual-action investigational therapy targeting both glucagon and GLP-1 receptors in a balanced 1:1 ratio in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD) and alcohol-associated liver disease (ALD). For more information, please visit www.altimmune.com. Follow @Altimmune, Inc. on LinkedInFollow @AltimmuneInc on X Investor Contact:Luis Sanay, CFAVice President, Investor [email protected] Media Contact:Real [email protected]
Investor releaseQuarter not tagged2026-07-28Altimmune Announces Positive Topline Results from RECLAIM Phase 2 Trial of Pemvidutide in Alcohol Use Disorder
GlobeNewswire
Altimmune Announces Positive Topline Results from RECLAIM Phase 2 Trial of Pemvidutide in Alcohol Use Disorder
Pemvidutide 2.4 mg delivered a statistically significant and clinically meaningful reduction in heavy drinking days, the primary endpoint of the trial Important secondary endpoints were also met, including two-level reduction in WHO risk drinking levels and zero heavy drinking days, both of which are recognized by the FDA as registrational endpoints A generally favorable tolerability profile was observed in the trial Conference call to be held today at 8:00 am ET GAITHERSBURG, Md., July 28, 2026 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company focused on serious liver diseases, today announced positive topline results from the RECLAIM Phase 2 trial evaluating pemvidutide, an investigational balanced glucagon/GLP-1 dual receptor agonist, in patients with moderate to severe alcohol use disorder (AUD). The trial met its primary endpoint with a highly statistically significant reduction in heavy drinking days (HDD) versus placebo, with consistent positive results across important secondary endpoints, including the World Health Organization (WHO) Risk Drinking Levels (RDL), zero HDD and phosphatidyl ethanol (PEth) levels. A generally favorable tolerability profile was observed in the trial. The Company plans to request an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) based on the results of the trial. “We are extremely encouraged by these compelling topline results, which showed a highly significant reduction in heavy drinking days and nearly two-thirds of patients treated with pemvidutide achieving a two-level reduction in their WHO-RDL, a clinically meaningful outcome for these patients,” said Christophe Arbet-Engels, M.D., Ph.D., Chief Medical Officer at Altimmune. “These data reflect pemvidutide’s strong and consistent efficacy across important measures of drinking behavior, together with a generally favorable tolerability profile in this difficult-to-treat disorder. Given the known detrimental effects of alcohol on the liver, the liver-directed impact of glucagon in pemvidutide may provide further benefit in the treatment of AUD over GLP-1 alone, underscoring pemvidutide’s promising potential differentiation.” Efficacy Data Key efficacy results included: Statistically significant reduction in the primary endpoint of HDD per week versus placebo (p=0.0014) Statistically significant re…Read full documentShow less
Pemvidutide 2.4 mg delivered a statistically significant and clinically meaningful reduction in heavy drinking days, the primary endpoint of the trial Important secondary endpoints were also met, including two-level reduction in WHO risk drinking levels and zero heavy drinking days, both of which are recognized by the FDA as registrational endpoints A generally favorable tolerability profile was observed in the trial Conference call to be held today at 8:00 am ET GAITHERSBURG, Md., July 28, 2026 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company focused on serious liver diseases, today announced positive topline results from the RECLAIM Phase 2 trial evaluating pemvidutide, an investigational balanced glucagon/GLP-1 dual receptor agonist, in patients with moderate to severe alcohol use disorder (AUD). The trial met its primary endpoint with a highly statistically significant reduction in heavy drinking days (HDD) versus placebo, with consistent positive results across important secondary endpoints, including the World Health Organization (WHO) Risk Drinking Levels (RDL), zero HDD and phosphatidyl ethanol (PEth) levels. A generally favorable tolerability profile was observed in the trial. The Company plans to request an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) based on the results of the trial. “We are extremely encouraged by these compelling topline results, which showed a highly significant reduction in heavy drinking days and nearly two-thirds of patients treated with pemvidutide achieving a two-level reduction in their WHO-RDL, a clinically meaningful outcome for these patients,” said Christophe Arbet-Engels, M.D., Ph.D., Chief Medical Officer at Altimmune. “These data reflect pemvidutide’s strong and consistent efficacy across important measures of drinking behavior, together with a generally favorable tolerability profile in this difficult-to-treat disorder. Given the known detrimental effects of alcohol on the liver, the liver-directed impact of glucagon in pemvidutide may provide further benefit in the treatment of AUD over GLP-1 alone, underscoring pemvidutide’s promising potential differentiation.” Efficacy Data Key efficacy results included: Statistically significant reduction in the primary endpoint of HDD per week versus placebo (p=0.0014) Statistically significant results on secondary endpoints, including two that are registrational endpoints Statistically significant change in percent of days with abstinence versus placebo (p=0.0075) Statistically significant reduction in PEth levels versus placebo (p<0.0001) Statistically significant reduction in body weight, as measured by a placebo-adjusted difference in change from baseline of 9.1% at 24 weeks (p<0.0001), with no evidence of plateauing Safety and Tolerability Data *2 vomiting, 1 constipation, 1 fatigue, 1 exacerbation of hemorrhoids Pemvidutide was generally well tolerated in this patient population with high unmet need. The new, simple two-step titration for the 2.4 mg dose may improve gastrointestinal (GI) tolerability compared to prior pemvidutide titration schemes. The majority of adverse events were mild to moderate in severity. There was one serious adverse event (SAE) (hyponatremia) in the pemvidutide arm that was deemed possibly related to treatment drug by the principal investigator. “As someone who has dedicated his career to understanding and treating alcohol use disorder, I recognize the significance of these findings, particularly given the current attention on the adverse health impact of heavy drinking. These results provide a consistent picture of treatment benefit on self-reported drinking outcomes, supported by objective PEth biomarker evidence,” said Henry Kranzler, M.D., Karl E. Rickels Professor of Psychiatry and Director, Center for Studies of Addiction, University of Pennsylvania Perelman School of Medicine, and Principal Investigator of the RECLAIM trial. “These data underscore the potential for pemvidutide to address multiple dimensions of alcohol use disorder by supporting abstinence and reducing heavy drinking, findings that build on prior evidence of its activity in the liver.” “These top-line data strengthen our confidence in pemvidutide's differentiation and its potential to benefit people living with MASH, AUD and ALD, who currently have limited treatment options,” said Jerry Durso, Chief Executive Officer and Chairman of the Board of Altimmune. “These results represent yet another important milestone for Altimmune as we continue to execute on our goal to bring pemvidutide to patients with serious liver diseases while creating value for shareholders.” Based on these data, Altimmune plans to request an End-of-Phase 2 (EOP2) meeting with the FDA to discuss the path forward for pemvidutide in AUD. Results from the RECLAIM trial will be submitted for presentation at a forthcoming medical conference and for publication in a peer-reviewed journal. Conference Call InformationAltimmune will host a conference call and webcast at 8:00 a.m ET today to discuss the RECLAIM topline data. The conference call will be webcast live on Altimmune’s Investor Relations (IR) website. Participants who would like to join by phone may register here to receive the dial-in numbers and unique pin to access the call. Following the conclusion of the call, the webcast will be available for replay on the IR page of the company’s website. About RECLAIM RECLAIM (NCT06987513) is a Phase 2 trial evaluating the safety and efficacy of pemvidutide in Alcohol Use Disorder (AUD) patients with BMI >25 kg/m2, and is the first Phase 2 multicenter study evaluating a dual glucagon-GLP-1 agonist in AUD to report results. Approximately 100 patients were randomized 1:1 to receive either 2.4 mg pemvidutide or placebo once weekly for 24 weeks. The primary endpoint of the trial was the change from baseline in the average number of heavy drinking days (HDD) per week, with secondary endpoints including the proportion of patients achieving a 2-level reduction in World Health Organization (WHO) Risk Drinking Levels (RDL), zero HDD, and absolute change from baseline in average levels of phosphatidylethanol (PEth), an objective serum biomarker of alcohol intake. The 2-level reduction in WHO risk drinking levels and zero HDD are recognized by the FDA as registrational endpoints. About AUD Alcohol use disorder (AUD) is a medical condition driven by an impaired ability to stop or control the harmful consumption of alcohol. AUD can also lead to serious health consequences, including liver cirrhosis, cardiovascular disease, and cancer. Additionally, many patients with AUD present with comorbidities including excess fat in the liver and obesity, further amplifying their risk for poor outcomes. The World Health Organization estimates that harmful alcohol consumption is the seventh leading cause of global death and disability, with alcohol accounting for 50% of all liver-related deaths. Today, it is estimated that 28 million adults in the U.S. suffer from AUD. Patients with AUD are characterized as mild, moderate or severe according to the DSM-5 criteria with approximately 12 million having moderate or severe forms of the disease. Only three drugs for AUD have been approved by the FDA, but these agents have limited efficacy for AUD and its comorbidities and are used by less than 2% of patients. There is a substantial unmet need for new and more effective treatments that not only reduce alcohol cravings and heavy drinking days but also can address the numerous other risks of the disease. About Pemvidutide Pemvidutide is a novel, investigational peptide with balanced 1:1 glucagon/GLP-1 dual receptor agonist activity, in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD) and alcohol-associated liver disease (ALD). The activation of glucagon receptors results in direct effects on the liver, including reductions in liver fat, inflammation and fibrosis, while GLP-1 receptors mediate metabolic effects such as appetite suppression and weight loss, and may play a role in pathways related to craving and reward. The FDA granted Fast Track designations to pemvidutide for the treatment of MASH and AUD, as well as Breakthrough Therapy Designation for MASH. In December 2025, the Company announced 48-week data from the IMPACT Phase 2b trial in MASH. In July 2026, the Company announced results from the RECLAIM Phase 2 trial in AUD. The RESTORE trial in ALD was initiated in July 2025, and enrollment completion is expected in the third quarter 2026. The Company plans to initiate the PERFORMA Phase 3 trial, a multinational, randomized, double-blind, placebo-controlled, parallel-group study of pemvidutide in patients with MASH in the third quarter of 2026. About Altimmune Altimmune is a late clinical-stage biopharmaceutical company developing therapies for patients with serious liver diseases. The Company’s lead candidate, pemvidutide, is a unique dual-action therapy targeting both glucagon and GLP-1 receptors in a balanced 1:1 ratio in development for the treatment of MASH, AUD and ALD. For more information, please visit www.altimmune.com. Forward-Looking Statements This press release has been prepared by Altimmune, Inc. ("we," "us," "our," "Altimmune" or the "Company") and includes certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including without limitation, the timing of key milestones for our clinical assets, the performance of our drug candidates in ongoing and future clinical trials including the RECLAIM trial (topline results of which are described herein), the ongoing RESTORE trial and the planned PERFORMA trial, evaluating pemvidutide in patients with MASH, AUD and ALD, the potential benefits of Fast Track and Breakthrough Therapy Designations and the prospects for regulatory approval, commercializing, market size, market potential, competitive landscape, or selling any product or drug candidates. In addition, when or if used in this presentation, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict,” “potential”, “suggest” and similar expressions and their variants, as they relate to the Company may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including risks such as delays in regulatory review, manufacturing and supply chain interruptions, access to clinical sites, enrollment, adverse effects on healthcare systems and disruption of the global economy; patient baseline characteristics which may vary and impact the success of future trials; the reliability of the results of studies relating to human safety and possible adverse effects resulting from the administration of the Company’s product candidates; the Company’s ability to manufacture clinical trial materials on the timelines anticipated; whether the FDA will agree with the Company's proposed development and regulatory strategy for pemvidutide in AUD, including following any End-of-Phase 2 meeting; the risk that results from the RECLAIM trial may not be predictive of results in the RESTORE trial, the planned PERFORMA trial, or any other future or larger clinical trial; the Company's need for substantial additional capital to complete development of pemvidutide, which may not be available on acceptable terms or at all; competition from other companies developing treatments for MASH, AUD and ALD; and the success of future product advancements, including the success of current and future clinical trials. Further information on the factors and risks that could affect the Company's business, financial conditions and results of operations are contained in the Company’s filings with the U.S. Securities and Exchange Commission, including under the heading “Risk Factors” in the Company’s latest annual report on Form 10-K, quarterly report on Form 10-Q and our other filings with the SEC, which are available at www.sec.gov. Investor Contact:Luis Sanay, CFAVice President, Investor [email protected] Media Contact:Real Chemistry [email protected]
Investor releaseQuarter not tagged2026-07-28Altimmune Shares Jump After Positive Phase 2 Alcohol Use Disorder Trial Results
InvestorsHub
Altimmune Shares Jump After Positive Phase 2 Alcohol Use Disorder Trial Results
Altimmune Inc. (NASDAQ:ALT) shares climbed 18% on Tuesday after the biotechnology company reported positive topline data from its Phase 2 RECLAIM study evaluating pemvidutide as a treatment for alcohol use disorder. The trial successfully achieved its primary endpoint, demonstrating a statistically significant reduction in heavy drinking days compared with placebo. Patients treated with pemvidutide 2.4 mg reduced heavy drinking days by an average of 4.20 days per week from baseline after 24 weeks, compared with a reduction of 2.75 days in the placebo group. The treatment produced a difference of 1.45 days versus placebo, with a p-value of 0.0014. The study also met key secondary endpoints recognised by the U.S. Food and Drug Administration as potential registrational measures. Among patients receiving pemvidutide, 64.4% achieved a two-level reduction in World Health Organization (WHO) Risk Drinking Levels, compared with 34.8% in the placebo group, producing a p-value of 0.0049. In addition, 42.2% of participants treated with pemvidutide recorded zero heavy drinking days between weeks 21 and 24 of the study, compared with 17.4% of those receiving placebo. Pemvidutide is an investigational dual glucagon and GLP-1 receptor agonist currently being developed as a treatment for moderate to severe alcohol use disorder. The RECLAIM study enrolled 100 patients, with 50 participants receiving pemvidutide 2.4 mg and the remaining 50 receiving placebo. The treatment was generally well tolerated, with most adverse events reported as mild to moderate. Nausea was experienced by 44% of patients receiving pemvidutide, compared with 24% in the placebo group, while vomiting occurred in 18% and 6% of patients, respectively. Overall treatment discontinuation rates were comparable between the two groups, at 20% for pemvidutide and 22% for placebo. Around 10% of patients in the treatment arm discontinued because of study drug-related adverse events. Following the positive Phase 2 results, Altimmune said it intends to request an End-of-Phase 2 meeting with the U.S. Food and Drug Administration to discuss the next stage of clinical development for pemvidutide in alcohol use disorder. Altimmune stock price
Investor releaseQuarter not tagged2026-06-17Altimmune Plans to Move Headquarters to New Jersey
MT Newswires
Altimmune Plans to Move Headquarters to New Jersey
Altimmune (ALT) said in a filing Tuesday that it plans to relocate its headquarters to Morristown, N
Investor releaseQuarter not tagged2026-06-12Why Is Altimmune (ALT) Down 11.3% Since Last Earnings Report?
Zacks
Why Is Altimmune (ALT) Down 11.3% Since Last Earnings Report?
A month has gone by since the last earnings report for Altimmune, Inc. (ALT). Shares have lost about 11.3% in that time frame, underperforming the S&P 500. Will the recent negative trend continue leading up to its next earnings release, or is Altimmune due for a breakout? Well, first let's take a quick look at the most recent earnings report in order to get a better handle on the recent catalysts for Altimmune, Inc. before we dive into how investors and analysts have reacted as of late. Altimmune’s Q1 Loss Narrower Than Expected, Revenues Nil Altimmune incurred a first-quarter 2026 loss of 18 cents per share, narrower than the Zacks Consensus Estimate of a loss of 25 cents. The company had recorded a loss of 26 cents per share in the year-ago quarter.The company did not generate any revenues in the first quarter, as it does not have a marketed drug in its portfolio. ALT's Q1 Results in Detail Research and development (R&D) expenses totaled $16.2 million in the reported quarter, up 2.3% year over year, primarily due to ongoing clinical studies and startup costs associated with the late-stage MASH study. R&D spending included $9.5 million in direct pemvidutide development costs.General and administrative expenses were $8.1 million, up 34.3% year over year, primarily driven by an increase in severance costs and professional fees.As of March 31, 2026, Altimmune had cash, cash equivalents and short-term investments of $332 million compared with $274 million as of Dec. 31, 2025. The company raised $75 million in a registered direct and $8 million via ATM in January-February 2026 and secured $225 million in gross proceeds from an oversubscribed public offering completed in April 2026, bringing pro forma cash to roughly $535 million as of April 30, 2026. Management expects its cash runway to support operations into 2029. In the past month, investors have witnessed a upward trend in fresh estimates. The consensus estimate has shifted 30.21% due to these changes. Currently, Altimmune has a subpar Growth Score of D, however its Momentum Score is doing a lot better with an A. However, the stock has a grade of F on the value side, putting it in the bottom 20% quintile for value investors. Overall, the stock has an aggregate VGM Score of F. If you aren't focused on one strategy, this score is the one you should be interested in. Estimates have been trending upward for the…Read full documentShow less
A month has gone by since the last earnings report for Altimmune, Inc. (ALT). Shares have lost about 11.3% in that time frame, underperforming the S&P 500. Will the recent negative trend continue leading up to its next earnings release, or is Altimmune due for a breakout? Well, first let's take a quick look at the most recent earnings report in order to get a better handle on the recent catalysts for Altimmune, Inc. before we dive into how investors and analysts have reacted as of late. Altimmune’s Q1 Loss Narrower Than Expected, Revenues Nil Altimmune incurred a first-quarter 2026 loss of 18 cents per share, narrower than the Zacks Consensus Estimate of a loss of 25 cents. The company had recorded a loss of 26 cents per share in the year-ago quarter.The company did not generate any revenues in the first quarter, as it does not have a marketed drug in its portfolio. ALT's Q1 Results in Detail Research and development (R&D) expenses totaled $16.2 million in the reported quarter, up 2.3% year over year, primarily due to ongoing clinical studies and startup costs associated with the late-stage MASH study. R&D spending included $9.5 million in direct pemvidutide development costs.General and administrative expenses were $8.1 million, up 34.3% year over year, primarily driven by an increase in severance costs and professional fees.As of March 31, 2026, Altimmune had cash, cash equivalents and short-term investments of $332 million compared with $274 million as of Dec. 31, 2025. The company raised $75 million in a registered direct and $8 million via ATM in January-February 2026 and secured $225 million in gross proceeds from an oversubscribed public offering completed in April 2026, bringing pro forma cash to roughly $535 million as of April 30, 2026. Management expects its cash runway to support operations into 2029. In the past month, investors have witnessed a upward trend in fresh estimates. The consensus estimate has shifted 30.21% due to these changes. Currently, Altimmune has a subpar Growth Score of D, however its Momentum Score is doing a lot better with an A. However, the stock has a grade of F on the value side, putting it in the bottom 20% quintile for value investors. Overall, the stock has an aggregate VGM Score of F. If you aren't focused on one strategy, this score is the one you should be interested in. Estimates have been trending upward for the stock, and the magnitude of these revisions looks promising. It comes with little surprise Altimmune has a Zacks Rank #2 (Buy). We expect an above average return from the stock in the next few months. Altimmune belongs to the Zacks Medical - Drugs industry. Another stock from the same industry, Esperion Therapeutics (ESPR), has gained 1% over the past month. More than a month has passed since the company reported results for the quarter ended March 2026. Esperion Therapeutics reported revenues of $80.1 million in the last reported quarter, representing a year-over-year change of +23.2%. EPS of -$0.10 for the same period compares with -$0.21 a year ago. For the current quarter, Esperion Therapeutics is expected to post a loss of $0.02 per share, indicating no change from the year-ago quarter. The Zacks Consensus Estimate remained unchanged over the last 30 days. The overall direction and magnitude of estimate revisions translate into a Zacks Rank #3 (Hold) for Esperion Therapeutics. Also, the stock has a VGM Score of D. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Altimmune, Inc. (ALT) : Free Stock Analysis Report Esperion Therapeutics, Inc. (ESPR) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

