Altimmune, Inc. quarterly report, Q3 FY2023

Altimmune, Inc. — Q3 2023 Form 10-Q

Reporting period: Three and nine months ended September 30, 2023; filed November 7, 2023. Altimmune is a clinical-stage biopharmaceutical company developing pemvidutide for obesity and liver disease and HepTcell for chronic hepatitis B. It has not generated product-sale revenue.

Financial results and liquidity

MetricQ3 2023Q3 2022Nine months 2023Nine months 2022
Revenue$0.36 million$0.002 million$0.39 million$0.04 million
Research and development expense$18.39 million$20.26 million$48.89 million$51.36 million
General and administrative expense$4.51 million$4.49 million$13.81 million$13.33 million
Operating loss$22.54 million$24.75 million$62.31 million$64.65 million
Net loss$20.67 million$23.52 million$56.81 million$63.05 million
Basic and diluted loss per share$0.39$0.48$1.10$1.37

Revenue reflects grant/contract-related adjustments, not product sales. For the nine-month period, operating cash use was $59.3 million, compared with $45.3 million a year earlier. Investing activities provided $21.7 million, largely from investment maturities and sales; financing activities provided $13.4 million, mainly from at-the-market (ATM) stock sales.

At September 30, 2023, cash, cash equivalents and restricted cash totaled $86.9 million and short-term investments were $53.9 million, or $140.8 million combined. Current assets were $153.0 million and current liabilities $11.9 million. Total liabilities were $16.2 million; the filing does not report material conventional debt. Accumulated deficit was $434.7 million. Management stated available resources, together with expected tax refunds and R&D incentives, were sufficient for at least 12 months from the financial statements’ issuance date.

Changes, outlook and material items

  • Nine-month net loss improved by $6.2 million year over year, while operating cash use increased by $14.0 million. Lower costs from completed earlier pemvidutide studies were partly offset by IMPACT trial startup, MOMENTUM trial and manufacturing costs, and higher non-project R&D spending.
  • Interest income rose to $5.4 million for the nine months, from $1.4 million, helping reduce net loss; this is investment income rather than operating revenue.
  • Altimmune sold 3.54 million shares under its 2023 ATM program for approximately $13.9 million net proceeds during the nine months. $135.7 million remained available under the program at September 30. Shares outstanding were 52.86 million at quarter-end, versus 49.20 million at December 31, 2022.
  • Management gave no financial revenue or earnings guidance. MOMENTUM Phase 2 obesity-trial topline results were expected in Q4 2023; the Phase 2b NASH IMPACT trial topline results were expected in Q1 2025. HepTcell Phase 2 data were planned for Q1 2024. The FDA granted pemvidutide Fast Track designation for NASH on October 24, 2023.
  • The filing reports that litigation claims were not reasonably possible or probable of material loss and that there were no material changes to previously disclosed risk factors. A potential Spitfire sales-milestone obligation of up to $80 million is contingent on specified product sales following FDA approval.
  • After quarter-end, holders net-cashlessly exercised 869,566 pre-funded warrants, receiving 869,530 shares. This increased the share count without material cash proceeds.

Important facts for investors to verify

  • Whether MOMENTUM results and subsequent clinical updates support the company’s development plans and anticipated timelines.
  • Cash burn, expected R&D incentive and tax-refund receipts, and whether management’s stated runway remains adequate as trial spending evolves.
  • Future ATM sales, share issuance and other potential dilution, including the post-quarter warrant exercise.
  • That reported revenue remains non-product revenue and that commercialization timing and future product revenue are uncertain.
  • Potential clinical, regulatory, funding and contingent-payment risks, including the Spitfire milestone terms.