Lisata Therapeutics, Inc. — Form 10-Q Summary
Reporting period: The filing covers the quarter and six months ended June 30, 2023, not 2022 Q2 as indicated in the request metadata. Lisata is a clinical-stage pharmaceutical company; it reported no revenue in the periods presented.
Financial performance and liquidity
| Metric | Q2 2023 | Q2 2022 | Six months 2023 | Six months 2022 |
|---|---|---|---|---|
| Revenue | $0 | $0 | $0 | $0 |
| Research and development expense | $3.162m | $3.234m | $6.341m | $6.516m |
| General and administrative expense | $3.713m | $3.486m | $7.378m | $6.824m |
| Operating loss | $(6.875)m | $(6.720)m | $(13.719)m | $(13.340)m |
| Net loss | $(4.027)m | $(6.626)m | $(10.214)m | $(10.852)m |
| Basic and diluted loss per share | $(0.50) | $(1.64) | $(1.28) | $(2.69) |
Net losses narrowed year over year, primarily reflecting a $2.330m income tax benefit in 2023 and higher investment income; operating expenses increased 2.3% in Q2 and 2.8% for the first half. G&A rose, partly due to severance following elimination of the Chief Business Officer position; R&D declined modestly as current LSTA1 trial and manufacturing work was offset by prior-year ischemic-repair program costs. The tax benefit principally relates to selling New Jersey net operating losses: Lisata received $2.2m in net proceeds and recorded $2.3m in tax benefits, with a $0.1m loss on sale.
For the six months, operating cash use was $12.380m, versus $10.704m a year earlier. Investing activities provided $3.564m, mainly from net marketable-security sales; financing provided $0.367m, including ATM share issuance and option exercises. Cash and cash equivalents were $23.690m and marketable securities were $33.936m at June 30, 2023, or approximately $57.6m combined. Working capital was approximately $57.1m. Total liabilities were $4.651m, including $0.383m of operating lease liabilities; the filing reports no debt balance. Management said available cash and marketable securities should fund operations for at least 12 months after issuance of the financial statements.
Material developments, outlook, and risks
- Pipeline: LSTA1 is the lead candidate, under study in multiple solid-tumor settings, including pancreatic cancer. Lisata described favorable safety, tolerability, and activity in prior trials; these are investigational results, not evidence of approval or commercial revenue. The company continues LSTA1 basket-trial start-up, ASCEND enrollment, and CMC work.
- Other programs: XOWNA’s FREEDOM trial remains suspended; further development depends on securing a strategic partner to fund a redesigned trial. HONEDRA enrollment in Japan was suspended, and the company is pursuing regulatory discussions and a Japanese partner. The company is also seeking partners for its CD34+ cell therapy programs.
- Capital needs: Management expects to use existing cash and securities and may pursue equity or debt financing, partnerships, grants, or asset sales. It cautioned that financing may not be available on acceptable terms; equity funding could dilute shareholders and debt could impose payment obligations and covenants.
- Licenses and legal contingency: Lisata gave MIT notice on June 30, 2023, to terminate a license effective December 30, 2023. A dispute with Lingmed over an alleged success fee is pending; Lisata denies the claims, and trial is scheduled for August 2, 2024. The filing does not quantify a potential loss.
- Subsequent event: In July 2023, Lisata agreed, subject to customary closing conditions, to transfer its TPN platform to Impilo in exchange for 768,500 shares of Impilo pre-seed preferred stock.
- Other: Management reported effective disclosure controls and no material changes in internal control over financial reporting. It disclosed no material changes to the risk factors in its 2022 Form 10-K.
Most important facts for investors to verify
- Whether LSTA1 trial progress produces meaningful clinical results and proceeds on expected timelines.
- Whether Lisata secures funding or partners for XOWNA, HONEDRA, and other programs, and the terms of any arrangements.
- Cash runway relative to operating burn, and availability and dilution effects of future financing.
- Status and potential financial impact of the Lingmed litigation and the MIT license termination.
- Closing and final economic terms of the TPN platform transfer to Impilo.