Altimmune, Inc. — Q1 2024 Form 10-Q
Reporting period: Three months ended March 31, 2024; balance-sheet comparisons are to December 31, 2023. Altimmune is a clinical-stage biopharmaceutical company developing treatments for obesity and liver diseases. Pemvidutide is its lead investigational candidate. The company has not generated product-sale revenue.
Financial results and liquidity
| Metric | Q1 2024 | Q1 2023 / prior date |
|---|---|---|
| Revenue | $5,000 | $21,000 |
| Research and development expense | $21.5 million | $17.2 million |
| General and administrative expense | $5.3 million | $4.5 million |
| Operating loss | $26.8 million | $21.8 million |
| Interest income | $2.4 million | $1.7 million |
| Net loss | $24.4 million | $20.1 million |
| Net loss per share, basic and diluted | $0.34 | $0.40 |
| Operating cash used | $16.4 million | $19.4 million |
| Cash, cash equivalents and restricted cash, March 31 | $79.0 million | $135.2 million at Dec. 31, 2023 |
| Short-term investments, March 31 | $103.0 million | $62.7 million at Dec. 31, 2023 |
Q1 comprehensive loss was $24.6 million, including a $157,000 unrealized investment loss. Product margins are not meaningful given negligible revenue and no product sales. Management reported $182.1 million in cash, cash equivalents, restricted cash and short-term investments at quarter-end. It believes available resources, together with expected R&D incentive receipts, can fund operations for at least 12 months from issuance of the financial statements. The company reported $15.4 million of total liabilities, including $552,000 of operating lease obligations; no funded borrowing balance is reported in the provided filing text.
Changes and business developments
- Net loss increased 22% year over year as operating expenses rose 23%; higher interest income partly offset the increase.
- Pemvidutide R&D expense increased 52% to $13.5 million, mainly reflecting the IMPACT Phase 2b MASH trial ramp-up and manufacturing activity. The increase was partly offset by the wind-down of the MOMENTUM obesity trial and completion of other studies.
- On March 27, the company reported MOMENTUM Phase 2 body-composition results: 74.5% of weight loss was from adipose tissue and 25.5% from lean mass.
- Also on March 27, Altimmune said the Phase 2 HepTcell response was insufficient to justify further clinical development and that development had stopped.
- Cash and cash equivalents fell, while short-term investments increased. Investing cash outflow was $39.5 million, primarily due to $53.5 million of investment purchases; the change in cash should not be read as operating burn alone.
Outlook, risks and contingencies
No specific revenue, earnings or clinical-trial guidance is provided in the filing text. Management says long-term capital needs may require additional equity or debt financing, government funding, or partnerships or asset sales. The company had $60.6 million remaining available under its at-the-market offering program at March 31, 2024; no shares were sold under the program during Q1. The company reported an accumulated deficit of $490.7 million and a history of operating losses and negative operating cash flow.
A securities class action was filed on May 6, 2024, after quarter-end, against the company and three current executives. It alleges misleading statements or omissions concerning shares acquired between December 1, 2023 and April 26, 2024; the company says it intends to defend the case vigorously. The filing also describes potential Spitfire acquisition milestone payments of up to $80 million, contingent on specified sales milestones after FDA approval. Management reported no material changes to the risk factors in its 2023 Form 10-K and stated disclosure controls were effective as of March 31, 2024.
Important facts for investors to verify
- Progress, timing, costs and clinical outcomes for pemvidutide, particularly the IMPACT MASH program; the reported MOMENTUM body-composition analysis is a trial result, not a commercial outcome.
- Cash runway assumptions, including clinical-trial spending, expected R&D incentive receipts and the pace of investment deployment.
- Potential dilution and financing plans, including use of the remaining $60.6 million ATM capacity; common shares outstanding were 70,899,134 at March 31 and 70,902,191 at May 3, 2024.
- Developments and potential financial impact of the securities class action, and any future exposure to contingent milestone payments.