SEC Filing Summary
Filing identity: The supplied filing is Caladrius Biosciences, Inc.’s Form 10-Q for the quarter ended June 30, 2021, filed August 5, 2021. This does not match the request metadata, which identifies Lisata Therapeutics, Inc. and 2020 Q2.
Business context and reporting period
Caladrius is a clinical-stage biopharmaceutical company developing autologous CD34+ cell therapies. Its programs include CLBS16 for coronary microvascular dysfunction, HONEDRA (CLBS12) for critical limb ischemia and Buerger’s disease, CLBS201 for diabetic kidney disease, and OLOGO (CLBS14) for refractory angina. The filing reports unaudited results for the three and six months ended June 30, 2021, with comparisons to 2020.
Financial results and liquidity
Amounts below are in millions of dollars, except per-share data. The filing reports no revenue; it provides no revenue or gross-margin figures.
| Metric | Q2 2021 | Q2 2020 | Six months 2021 | Six months 2020 |
|---|---|---|---|---|
| Research and development expense | $4.329 | $1.818 | $9.405 | $3.317 |
| General and administrative expense | $2.818 | $2.474 | $5.828 | $5.032 |
| Total operating expenses / operating loss | $7.147 | $4.292 | $15.233 | $8.349 |
| Net income (loss) | $(5.682) | $6.602 | $(13.745) | $2.616 |
| Net income (loss) per share, basic and diluted | $(0.10) | $0.50 | $(0.27) | $0.22 |
The 2021 periods included a $1.5 million income-tax benefit from selling New Jersey net operating losses; the 2020 comparisons included a $10.9 million benefit from a similar sale. These tax-related items materially affect year-over-year net income comparisons.
At June 30, 2021, cash and cash equivalents were $12.935 million and marketable securities were $93.155 million, totaling about $106.1 million. Working capital was about $104.2 million and stockholders’ equity was $104.7 million. Total liabilities were $3.9 million, primarily current liabilities; the filing reports no borrowings. Management stated existing cash would fund operating expenses for at least 12 months after issuance of the financial statements.
For the first six months of 2021, operating cash use was $12.602 million, investing cash use was $76.294 million (primarily net purchases of marketable securities), and financing provided $85.319 million. Cash and cash equivalents declined by $3.577 million to $12.935 million; the larger pool of liquid resources includes marketable securities.
Material changes versus prior comparable periods
- Q2 operating expenses rose 67% year over year; six-month expenses rose 82%. Management attributed most of the increase to higher R&D spending, especially CLBS16 Phase 2b trial activity. Six-month R&D increased 184% year over year.
- The company moved from net income in 2020 to net loss in 2021, while prior-year results benefited substantially from New Jersey NOL sales. The 2021 loss also reflects higher operating expenses.
- Common shares outstanding increased from 19.378 million at December 31, 2020 to 59.517 million at June 30, 2021. The January private placement and February registered direct offerings generated substantial financing proceeds and included warrants.
- Marketable securities increased from $18.061 million at year-end 2020 to $93.155 million at June 30, 2021, largely reflecting deployment of cash into securities.
Outlook, risks, and notable items
- Management projected completion of enrollment in the 105-patient FREEDOM Phase 2b trial in Q3 2022, with final six-month follow-up data expected in Q2 2023. COVID-19 effects and proposed protocol changes contribute to timing uncertainty.
- A Phase 2 proof-of-concept study of CLBS201 was planned to begin in the second half of 2021, subject to protocol and institutional review board steps; safety data from its six-patient run-in arm were projected by Q2 2022.
- HONEDRA trial enrollment in Japan continued to be significantly delayed by COVID-19 restrictions and hospital capacity constraints. The company said the completion date could not be predicted clearly.
- The company decided not to pursue OLOGO’s Phase 3 study independently after the FDA did not accept a proposed reduction in the required 400-patient trial; it would continue seeking a partner.
- Caladrius said it may need additional capital over the longer term. Additional financing may be unavailable or unfavorable, equity financing may dilute shareholders, and debt could bring payment obligations and restrictive covenants. A new $50 million at-the-market offering facility was available, but no shares had been sold under it by June 30, 2021.
- Management reported no material changes to previously disclosed risk factors or legal proceedings, and no material changes in internal control over financial reporting. It reported no off-balance-sheet arrangements.
Important facts for investors to verify
- Confirm that this Caladrius Biosciences 2021 Q2 filing, rather than a Lisata Therapeutics 2020 Q2 filing, is the intended document.
- Track cash use and the composition, liquidity, and maturities of the marketable-securities portfolio against management’s stated 12-month runway.
- Monitor clinical-trial enrollment and timelines for FREEDOM, HONEDRA, and CLBS201, including the impact of COVID-19 and protocol changes.
- Assess dilution and potential warrant exercises following the 2021 share and warrant issuances, and any future use of the ATM facility.
- Distinguish operating performance from the income-tax benefits associated with New Jersey NOL sales when comparing periods.