Altimmune, Inc. (NASDAQ:ALT) reported its second-quarter financial results before Tuesday’s opening bell.
Below are the transcripts from the Q2 earnings call.
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OPERATOR
Good morning ladies and gentlemen and welcome to the Altimmune Second Quarter 2025 Financial Results Conference call. At this time, all participants are in 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 11 on your telephone. You will then hear an automated message that your hand is raised. As a reminder, this call is being recorded on our Let me introduce your host for today’s conference call, Lee Roth, President of Burns McClellan Investor Relations Advisor to Altimune. Lee, you may begin.
Lee Roth (President of Burns McClellan Investor Relations Advisor)
Thanks, Olivia. Good morning everyone. Once again, thank you for joining us for the Altimmune second quarter 2025 financial results and Business Update conference call. On today’s call you’ll hear from Dr. Vipin Garg, our Chief Executive Officer, Dr. Scott Harris, our Chief Medical Officer and Greg Weaver, our Chief Financial Officer, Dr. Scott Roberts, Our Chief Scientific Officer and Ray Jord, our Chief Business Officer will join us for the Q and a. Our second quarter 2025 financial results and corporate update press release was issued earlier this morning and it can be found on the Investor Relations section of the Altimmune website. Before we begin, I’d like to remind everyone that remarks made about future expectations, plans and prospects constitute forward looking statements for purposes of the 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 and these could cause our actual results to differ materially from those indicated. For a full review of the risk factors that could affect the Company’s future results and operations, we refer you to the Company’s filings with the sec. I also direct you to read the forward looking statement disclaimer in our press release issued this morning which is available on our website. Any statements made on this call speak only as of today’s date, August 12, 2025 and the Company does not undertake any obligation to update any 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 the altimmune website. With that, it’s my pleasure to turn the call over to Dr. Vipin Garg, President and Chief Executive Officer of Altimune.
Dr. Vipin Garg (President and Chief Executive Officer)
Vipin thank you Lee Good morning everyone and thank you for joining us today for our second quarter financial results and corporate update. As many of you know, we presented the 24 week top line data from the impact trial at the end of June as we shared Pemvedutide achieved statistical significance in the primary endpoint of match resolution and across multiple objective measures of efficacy at 24 weeks of treatment. These included all noninvasive markers of inflammation and fibrosis, liver fat reduction and weight loss, along with best in class safety and tolerability without the need for dose titration. These data will serve as the foundation of the package that we take to the FDA for our end of Phase 2 meeting in the fourth quarter and will inform the design of our Phase 3 program. In addition to the advancement of our NASH program, our Phase two trials in AUD and ALD, Reclaim and Restore are now underway. Alcohol use Disorder and alcohol-associated liver diseases are two indications with significant unmet needs and few to no treatment options for which we believe pembidutide may be particularly well suited. As we announced yesterday, our board has appointed Jerry Durso as Chairman of the board, succeeding Dr. Mitch Sayer who has served in this role for the past seven years and will remain with us as a non Executive Director. This change reflects our planned advancement to Phase three development of pemvidutide in mash. Gerry has a wealth of commercial and corporate development experience including the building of a successful liver franchise as CEO of Intercept prior to its acquisition. We are excited to continue moving forward under Jerry’s leadership and look forward to Mitch’s ongoing contribution with 1.83.1 million in cash and cash equivalent. We have considerably strengthened our balance sheet as we work to continue to advance the development of Pembidutide and look forward to reaching additional milestones including the full 48 week impact data as the year progresses. With that, I’ll now turn the call over to Dr. Scott Harris, our Chief Medical Officer to provide a clinical development update.
Dr. Scott Harris (Chief Medical Officer)
Scott thank you Vipin. Those of you on the call with us are likely familiar with the impact top line data that we reported about six weeks ago. I’d like to expand upon a few of the key highlights of this positive and important data set. First, we achieved match resolution up to 59.1% of subjects, a highly statistically significant result after 24 weeks of treatment. On the other measure of fibrosis improvement, we did not reach statistical significance but clear evidence of anti fibrotic activity was observed that was supported by additional objective measures of fibrosis improvement. As Vipin noted, multiple measures of efficacy that were assessed at the 24 week time point achieved statistical significance. We demonstrated impressive results in all of the non invasive tests of liver fibrosis including enhanced liver fibrosis and vibration controlled transient elastography. In addition, the path URI based analysis of biopsies the showed a statistically significant improvement in liver fibrosis in a supplemental analysis. We recently completed our analysis of another important non invasive test of fibro inflammation corrected T1 imaging or CT1 where a class leading effect for pemvidutide was observed at the 24 week time point. CT1 is a reproducible MRI based liver imaging method that has been correlated with changes in liver inflammation and fibrosis in clinical studies. Decreases in CT1 relaxation time of 80 milliseconds or greater have been correlated with improvements in liver inflammation and fibrosis in clinical studies. At 24 weeks, mean decreases from baseline and CT1 relaxation time were 145.0 and 147.9 milliseconds in the 1.2 and 1.8 milligram pemvidutide treatment arms respectively, compared with a decrease of 27.5 milliseconds in placebo representing a P value of less than 0.001 for both doses. These new data add additional depth to the data demonstrating that strong anti inflammatory and antifibrotic activity of pemvedutide treatment. In addition to these impressive effects on the liver, pemvedutide was associated with a greater than 6% decrease in body weight at 24 weeks of treatment with a weight loss trajectory indicating that further weight loss was likely. Decreases in body weight are important in MASH patients as they succumb to the complications of obesity at greater rates than the complications of liver disease until cirrhosis actually develops. In the aggregate, the impact top line data compare very favorably to other NASH therapies including those that have read out at much later time points. Now moving to safety, Pemvidutide demonstrated potentially class leading results in that important area. Through 24 weeks Pemvidutide was remarkably well tolerated with only a single adverse event related discontinuation across the two pempidutide treatment arms versus two adverse event related discontinuations in the placebo group. It is worth noting that this excellent tolerability was achieved in the absence of dose titration which is unique for our GLP1. For GLP1 based agents, the ability to start patients in a dose that is both effective and tolerable will be highly attractive to prescribers and will be another key differentiator for our therapy. We’re continuing to analyze the 24 week data and look forward to providing updates as the results become available. The team is preparing for our fourth quarter end to phase two meeting with FDA that will further guide our phase three plans. We will also be reporting the full 48 week data in the fourth quarter. This data will include the non invasive tests that were reported at the 24 week readout. Weight Loss and Safety in addition to our NASH program, we’ve made progress in the development of pemvidutide in two additional indications, AUD and ALD, with the initiation of phase 2 trials in these indications in May and July. AUD and ALD are serious and highly prevalent conditions. Recurrent treatment approaches are inadequate and innovation has been limited. We claim our AUD trial is a 24 week trial evaluating weekly 2.4 milligram pempedutide versus placebo. The primary endpoint is the change in the number of heavy drinking days with key secondary endpoints including other measures of alcohol intake and weight loss including the World Health Organization risk drinking level which has recently been accepted by FDA as an additional basis of approval in this indication. Restore the Phase two trial and ALDI started enrolling in July. It is a 48 week trial evaluating the 2.4 milligram weekly dose of pemfidutide versus placebo with a primary endpoint of change in liver stiffness measurement at 24 weeks. Liver stiffness is a non invasive measure of liver inflammation and fibrosis that characterizes the prognosis and severity of ALD. Key secondary endpoints include an assessment of liver stiffness at 48 weeks as well as changes in ELF score, alcohol consumption and body weight at both 24 and 48 weeks. And with that I’ll turn it now over to Greg Weaver who will review our second quarter financial results.
Greg Weaver (Chief Financial Officer)
Greg thanks Scott. Beginning with the balance sheet, we finished the second quarter with total cash of 183.1 million. That’s an increase of approximately 40% over our cash position at the start of this year. We’ve raised 88 million in gross equity capital this year while adding the flexibility of $100 million Hercules debt facility, which we announced in the second quarter and drew down 15 million from that facility at signing. These strategic financial moves are part of our ongoing efforts to ensure that our balance sheet is able to support the continuing clinical development of pemvidutide. We are committed to staying focused on driving value as we work to position PEMVI to benefit NASH patients. Now to briefly comment on the Q2 financial results. First, R&D expenses which were 17.2 million for the three months ended June 30 as compared to 21 million in the same period of 2024 and this amount includes $11.2 million of direct costs related to pemvidutide development. Breaking that down further, including approximately $5.5 million for the impact phase 2b trial, $2.6 million for AUD and ALD startup phase 2 costs and $1 million for our pemvedutide …