On February 28, 2023 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported financial results for the fourth quarter and full year ended December 31, 2022, and provided a business update (Press release, Altimmune, FEB 28, 2023, View Source [SID1234627896]).
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"The next twelve-months is an important period for potential value-creating data readouts and the clinical development of pemvidutide, our GLP-1/glucagon dual-receptor agonist which is being developed for the treatment of both obesity and NASH. We are looking forward to announcing the top-line 24-week interim results from our MOMENTUM Phase 2 obesity trial in the second half of March," said Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune. "In addition, based on the compelling data from our recently completed trial in non-alcoholic fatty liver disease (NAFLD), which included greater than a 75% reduction in liver fat content and significant reductions in non-invasive markers of liver inflammation, we expect to initiate a Phase 2b biopsy-driven trial of pemvidutide in NASH in mid-2023. We expect the key endpoints of this trial to be NASH resolution and fibrosis improvement, both assessed following 24 weeks of treatment. Pemvidutide possesses key attributes that we expect to be important for both obesity and NASH, including the potential for robust reductions in body weight, liver fat, and liver inflammation, along with positive effects on serum lipids and blood pressure. We believe that the absence of dose titration further distinguishes pemvidutide from other incretin-based agents."
Recent Highlights and Anticipated Milestones:
Pemvidutide
Positive top-line data readout from 24-week (12-week extension) Phase 1b NAFLD trial in December 2022
Greater than a 75% relative reduction in liver fat content achieved, with over 50% of subjects achieving normalization of liver fat, at the 1.8 mg dose.
Significant reductions in serum alanine aminotransferase (ALT) and corrected T1 (cT1) observed, both established markers of liver inflammation, at the 1.8 mg dose.
Mean weight loss of 7.2% (placebo adjusted 6.0%) in subjects without diabetes, at the 1.8 mg dose.
Glycemic control maintained with trends toward improvements in fasting glucose and HbA1c in subjects with type 2 diabetes.
Low rates of treatment discontinuations due to adverse events.
Clinically meaningful reductions in blood pressure with minimal increases in heart rate.
24-week interim analysis of approximately 160 subjects in MOMENTUM Phase 2 obesity trial expected in the second half of March 2023
This Phase 2 trial is being conducted at 30 sites across the U.S., with Dr. Lou Aronne, Professor of Clinical Medicine, Weill Cornell Medical College, a leading authority in obesity and obesity clinical trials, serving as the Principal Investigator.
The trial was designed to enroll approximately 320 non-diabetic subjects with obesity, or overweight with at least one co-morbidity. Subjects were randomized 1:1:1:1 to 1.2 mg, 1.8 mg, 2.4 mg pemvidutide or placebo administered weekly for 48 weeks in conjunction with diet and exercise.
At the 24-week interim analysis, the readout parameters are expected to include weight loss as measured by the relative (percent) change in body weight at 24 weeks compared to baseline, serum lipid profiles, adverse events, vital signs, glucose control and study discontinuations.
Initiation of Phase 2b NASH trial expected mid-2023
This Phase 2b biopsy-driven NASH trial will be conducted at approximately 60 sites in the U.S., with Dr. Stephen Harrison, Medical Director, Pinnacle Research, and Adjunct Professor of Medicine, Oxford University, who led our 12-week NAFLD trial and 12-week extension trials, serving as the principal investigator.
The key endpoints will be NASH resolution and fibrosis improvement after 24 weeks of treatment.
The trial is expected to commence mid-2023 with top-line results expected in the first half of 2025.
HepTcell
Enrollment in the Phase 2 clinical trial in chronic hepatitis B is over 90% complete
The trial was designed to enroll approximately 80 subjects with inactive chronic hepatitis B randomized 1:1 to HepTcell or placebo.
Key endpoints include virological markers of hepatitis B infection.
Data readout is expected in the first half of 2024 after all subjects complete the 6-month course of treatment.
Patents
On January 3, 2023, the United States Patent and Trademark Office issued the patent "IMPROVED PEPTIDE PHARMACEUTICALS FOR TREATMENT OF NASH AND OTHER DISORDERS", patent number 11,541,028, with an expiry of no earlier than January 3, 2039. The patent claims the use of pemvidutide for treating fatty liver diseases including NAFLD and NASH.
Financial Results for the Three Months Ended December 31, 2022
Altimmune had cash, cash equivalents and short-term investments totaling $184.9 million at December 31, 2022.
Revenue was negligible for the three months ended December 31, 2022 compared to $3.3 million in the same period in 2021, as we are closing out the remaining government contracts due to the discontinuation of development activities for the T-COVID and NasoShield programs in 2021.
Research and development expenses were $19.2 million for the three months ended December 31, 2022, compared to $20.2 million in the same period in 2021. The expenses for the quarter ended December 31, 2022 included $13.4 million in direct costs related to development activities for pemvidutide and $1.9 million in direct costs related to development activities for HepTcell.
General and administrative expenses were consistent period-over-period at $3.8 million for each of the three months ended December 31, 2022 and 2021.
Net loss for the three months ended December 31, 2022 was $21.7 million, or $0.43 net loss per share, compared to a net loss of $23.9 million, or $0.57 net loss per share, in the same period in 2021.
Conference Call Information:
Date: Tuesday, February 28, 2023
Time: 8:30 am Eastern Time
Webcast: To listen, the conference call will be webcast live on Altimmune’s Investor Relations website at View Source
Dial-in: To participate or dial-in, 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 Investor Relations 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.