On November 13, 2019 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported financial results for the quarter ended September 30, 2019 and provided a business update (Press release, Altimmune, NOV 13, 2019, View Source [SID1234551146]).
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"We are pleased with our progress in 2019, as we have successfully diversified our product pipeline while minimizing cash burn," said Vipin K. Garg, Ph.D., President and Chief Executive Officer. "The Altimmune team continues to deliver on the R&D front with expected IND filings for ALT-801 and HepTcell during 2020. In addition, we are preparing for the initiation of the Phase 1b trial of our NasoShield program in the first quarter of 2020."
Dr. Garg added, "In ALT-801 and HepTcell, we are developing two liver disease drug candidates for very large, unaddressed patient populations, and in NasoShield, we are developing a drug candidate with the potential to disrupt the nearly $300 million per year anthrax vaccine market, which currently only has one participant. As we look forward to 2020, we believe that Altimmune has sufficient resources to advance our ongoing clinical programs and deliver on multiple value creating R&D milestones for our shareholders."
Recent Highlights
ALT-801 pre-clinical data presented at multiple conferences
Since acquiring ALT-801, a potent GLP-1/Glucagon receptor dual agonist for the treatment of non-alcoholic steatohepatitis (NASH), the Company has presented the IND-enabling preclinical data and Phase 1 clinical trial plans at the H.C. Wainwright NASH Investor Day, the B. Riley NASH KOL Symposium, and the JMP Securities NASH Forum. ALT-801 is a peptide-based therapeutic candidate with balanced agonist activity on both the GLP-1 and glucagon receptors and a differentiated PK profile. ALT-801 is designed to treat the underlying metabolic dysfunction and obesity that leads to NASH, the most severe form of non-alcoholic fatty liver disease (NAFLD). The Company is preparing for an IND submission in 2020, with data readouts from a Phase 1 clinical trial anticipated during 2021.
NASH KOL call with Dr. Stephen Harrison on December 5
Altimmune is hosting a NASH KOL call with Dr. Stephen Harrison on December 5 at 11 am, EST. In the coming days, a copy of the invitation will be posted to the events and presentations page on our website, www.altimmune.com. Dr. Harrison, a leading authority in the development of NASH therapies, is a visiting professor of hepatology at the Radcliffe Department of Medicine, University of Oxford as well as the medical director for Pinnacle Clinical Research and the president of Summit Clinical Research. The call will include commentary from Dr. Harrison on the evolving field of NASH product candidates, a presentation on ALT-801 by Altimmune management, followed by an open question and answer session with all participants.
NasoShield awarded $3.7 million BARDA funding for Phase 1b trial
In Q3, the Company modified its existing anthrax vaccine development contract with the Biomedical Advanced Research and Development Authority (BARDA) resulting in $3.7 million additional funding. The supplemental funding will support the conduct of a Phase 1b clinical trial of NasoShield to evaluate alternative methods of intranasal dosing in humans. NasoShield is being developed as a single-dose, intranasal anthrax vaccine, and is the only anthrax product supported by BARDA that potentially offers transformational improvements over the current two and three dose vaccines. The NasoShield program is funded through a contract with BARDA (HHSO100201600008C), with a total potential value of $133.7 million if all options in the contact are exercised.
M. Scott Harris, M.D. appointed as Chief Medical Officer
In September, the Company appointed M. Scott Harris, M.D. as Chief Medical Officer. Dr. Harris is a seasoned medical professional with extensive experience in hepatology and gastroenterology and broad expertise in managing clinical trials from early stage development through successful Phase 3 trials. Dr. Harris has an M.D. from Harvard Medical School and an MS in Administrative Medicine and Population Health from the University of Wisconsin Medical School. His post-graduate training includes residencies at John Hopkins Hospital and the University of Pennsylvania, and a Gastroenterology and Hepatology Fellowship at the Yale University School of Medicine.
Financial Results for the Third Quarter Ended September 30, 2019
At September 30, 2019, the Company had cash, cash equivalents and short-term investments of $39.2 million. During the third quarter, the Company invested a portion of its cash balances in investment grade securities to maximize the yield on its resources. All investments are highly liquid and immediately accessible.
Revenue in the third quarter was $0.64 million compared to $2.6 million in the prior year period. The change was due to a decrease in billings under the Company’s U.S. government contracts due to timing of manufacturing and clinical trials.
Research and development expenses in the third quarter were $8.7 million compared to $4.7 million in the prior year period. The increase was attributable to IPR&D expense recognized in conjunction with the acquisition of Spitfire Pharma, Inc., offset by lower manufacturing and clinical trial costs on its programs.
General and administrative expenses in the third quarter were $2.2 million compared to $2.0 million in the prior year period. The increase was due primarily to an increase in insurance expense and stock compensation.
The Company recognized $1.0 million in impairment charges during Q3 related to its SparVax-L program. The development contract with NIAID ended in Q3 2019, and no further funding has been identified. As disclosed by BARDA, U.S. government funding now will focus on post-exposure vaccines that offer transformational improvements over a two-dose vaccine. Since SparVax-L is a two-dose vaccine candidate and our NasoShield program fits the government’s funding profile with active funding, additional development of SparVax-L is not expected.
Net loss attributed to common stockholders for the third quarter was $10.9 million, or ($0.74) per share, compared to $2.3 million, or ($1.73) per share in the same period of 2018. The higher net loss is primarily attributable to a $7.2 million charge related to the July 2019 acquisition of Spitfire Pharma, Inc. and the $1 million impairment described above.
Conference Call Information
Altimmune will host a conference call to discuss the company’s third quarter results and other business information.
Date:
Thursday, November 19, 2019
Time:
8:30am Eastern Time
Domestic:
855-327-6837
International:
631-891-4304
Conference ID:
10008064
Webcast:
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 investor relations portion of its website as a means of disclosing
material non-public information and for complying with disclosure obligations under Regulation FD.