On November 9, 2021 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported financial results for the three- and nine-months ending September 30, 2021 and provided a corporate update (Press release, Altimmune, NOV 9, 2021, View Source [SID1234595124]).
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"The third quarter was a momentous time for our pemvidutide (ALT-801) program, as we delivered on positive topline data for the 12-week Phase 1 trial, cleared an IND in non-alcoholic steatohepatitis (NASH) with the FDA and initiated a 12-week Phase 1b study in non-alcoholic fatty liver disease (NAFLD)," remarked Vipin K. Garg, Ph.D., President and Chief Executive Officer at Altimmune. "In addition to the previously announced 12-week data showing double-digit weight loss in the 1.8 mg arm without the need for dose titration, we now have MRI-PDFF data in a subset of subjects with hepatic steatosis, or fatty liver, from that study demonstrating a remarkable reduction in liver fat to undetectable levels after only 6 weeks of pemvidutide treatment. These findings show the potential of pemvidutide in the treatment of both obesity and NASH, and we look forward to sharing the data from our ongoing Phase 1b trial in NAFLD and initiating Phase 2 trials for obesity and NASH in 2022."
Program Highlights:
Pemvidutide1 (ALT-801)
Announced weight loss data from 12-week Phase 1 clinical trial of pemvidutide in overweight and obese subjects
Subjects achieved mean weight losses of 4.9%, 10.3%, and 9.0% at 1.2 mg, 1.8 mg, and 2.4 mg doses, respectively
Once-weekly dosing regimen was well-tolerated without dose titration
Clinically meaningful reductions in serum lipids and blood pressure
No discontinuations due to adverse events
Obesity program advancing towards 48-week Phase 2 trial in the first half of 2022
Investigational New Drug application (IND) for obesity expected to be submitted by year end 2021
48-week Phase 2 obesity study expected to commence in the first half of 2022
1 proposed INN
Reduction in liver fat by MRI-PDFF exploratory analysis in recently completed Phase 1 study
MRI-PDFF data on liver fat content have now been analyzed through 6 weeks of treatment. While the trial inclusion criteria did not pre-specify a minimum liver fat content, the study did enroll a number of subjects with hepatic steatosis or fatty liver, defined as liver fat content greater than or equal to 5%. Five subjects had baseline hepatic steatosis (liver fat content ranging from 5.5 to 19.5%) and received pemvidutide at 1.8 mg or 2.4 mg dose levels. In each of these subjects, liver fat levels fell to undetectable levels within 6 weeks of treatment, representing a greater than 90% reduction in the liver fat content. These findings reinforce the results from preclinical studies of pemvidutide, which demonstrated statistically greater reductions in liver fat than an equivalent dose of semaglutide and confirm the combined beneficial effects of weight loss and glucagon on liver fat metabolism.
Pemvidutide IND application for NASH cleared and enrollment initiated in Phase 1b clinical trial in NAFLD, with topline data expected in the first half of 2022
The Phase 1b, 12-week NAFLD trial is being conducted in the US, with Dr. Stephen A. Harrison serving as Principal Investigator
The study will include diabetic and non-diabetic subjects, with a primary efficacy end point of the change in liver fat as measured by MRI-PDFF, and a key secondary endpoint of weight loss at Week 12
A 52-week biopsy driven Phase 2 NASH trial is expected to follow the conclusion of the NAFLD trial
Additional activities for continued development of pemvidutide
Drug-drug interaction trial of pemvidutide has been initiated in Australia, with results expected in the first half of 2022
A 12-week study to be initiated in Q1 2022 in the US to further characterize safety and pharmacokinetics of pemvidutide in diabetic subjects
HepTcell
Enrollment progressing in international Phase 2 clinical trial in chronic hepatitis B subjects, with topline data expected in the second half of 2022
Study readouts to include virological markers of hepatitis B infection
Financial Results for the Three and Nine Months Ended September 30, 2021
Altimmune had cash, cash equivalents, short-term investments and restricted cash totaling $199.9 million at September 30, 2021 compared to $216.0 million at December 31, 2020.
Revenue was $0.2 million for the three months ended September 30, 2021 compared to $2.9 million in the same period in 2020. The change in revenue quarter over quarter was primarily due to a decrease in MTEC/DoD revenue during the current period due to the timing of clinical trials and development activities for T-COVID.
Research and development expenses were $29.2 million for the three months ended September 30, 2021, compared to $17.0 million in the same period in 2020. The change was primarily the result of increased expenses related to development activities for the Company’s COVID-19 programs, offset by a decrease in the fair value of contingent consideration liability connected with the acquisition and development of pemvidutide.
General and administrative expenses were consistent period-over-period with $4.2 million recognized for the three months ended September 30, 2021 and $4.2 million in the same period in 2020.
Net loss for the three months ended September 30, 2021 was $33.5 million, or $0.81 net loss per share, compared to $17.8 million in the same period in 2020, or $0.54 net loss per share. Net loss for the nine months ended September 30, 2021 was $73.2 million, or $1.79 net loss per share, compared to $38.4 million in the same period in 2020, or $1.74 net loss per share.
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.
About Pemvidutide
Pemvidutide (proposed INN, formerly known as ALT-801) is a novel, investigational, peptide-based GLP-1/glucagon dual receptor agonist for obesity and non-alcoholic steatohepatitis (NASH). Altimmune believes the treatment of obesity is the cornerstone of treating NASH and its co-morbidities and views these conditions as significant unmet medical needs.
About HepTcell
HepTcell is a novel immunotherapeutic comprised of nine synthetic peptides representing conserved hepatitis B (HBV) sequences formulated with IC31, a TLR9-based adjuvant from Valneva SE. The HBV-directed peptides are designed to drive T cell responses against all HBV genotypes towards a functional cure for chronic HBV in patients of diverse genetic backgrounds.