Filing and reporting period
The supplied filing is Caladrius Biosciences, Inc.’s Form 10-Q for the quarter ended March 31, 2022—not a Lisata Therapeutics filing for 2021 Q1, as the request metadata indicates. Caladrius is a clinical-stage biopharmaceutical company developing CD34+ cell therapies. It reported no revenue in the provided statements.
Financial results and liquidity
Amounts below are in millions of dollars, except per-share data.
| Metric | Q1 2022 | Q1 2021 |
|---|---|---|
| Research and development expense | $3.278 | $5.076 |
| General and administrative expense | $3.342 | $3.010 |
| Total operating expenses / operating loss | $6.620 | $8.086 |
| Net loss attributable to common stockholders | $4.226 | $8.063 |
| Basic and diluted loss per share | $0.07 | $0.19 |
| Net cash used in operating activities | $5.642 | $7.975 |
- At March 31, 2022, cash and cash equivalents were $12.747 million and marketable securities were $75.772 million, totaling $88.519 million. Working capital was approximately $87.9 million.
- Total assets were $91.463 million, total liabilities $3.222 million, and total stockholders’ equity $88.241 million. The filing identifies no borrowings; liabilities include operating lease obligations.
- Cash decreased by $11.9 million in the quarter. Investing cash outflow of $6.090 million primarily reflected net purchases of marketable securities; financing cash outflow was $0.168 million.
- Gross margin is not applicable to the reported results because the filing reports no revenue.
Changes versus prior period
- Operating expenses fell 18%, primarily because research and development expense declined $1.798 million (35%) as XOWNA manufacturing start-up and process-development costs decreased. General and administrative expense rose $0.332 million (11%), primarily due to fees related to reviewing strategic transactions.
- Net loss improved by $3.837 million. The comparison includes a $2.479 million income-tax benefit in 2022 from selling New Jersey net operating loss tax benefits; without that benefit, the reported pre-tax loss was $6.705 million.
- Operating cash use declined $2.333 million. Q1 2021 financing had included substantial equity proceeds, whereas Q1 2022 had no reported common-stock issuance proceeds.
Outlook, developments, and risks
- Management said existing cash was expected to fund operating expenses for at least 12 months following issuance of the financial statements, absent any impact from the proposed Cend merger. It also cautioned that future capital needs are uncertain and additional financing may not be available on acceptable terms.
- On April 26, 2022, after quarter-end, Caladrius agreed to merge with Cend Therapeutics, subject to shareholder approvals and other conditions. Former Cend holders and pre-merger Caladrius holders were each expected to own approximately 50% of the combined company, subject to adjustments. A closing condition included a minimum net-cash threshold expected to be approximately $64.9 million for a third-quarter 2022 closing.
- Caladrius also agreed to invest approximately $10 million in Cend Series D preferred stock before the merger closing. The merger could fail to close, dilute existing holders, or entail termination fees or expense reimbursement under specified circumstances.
- The company reported ongoing enrollment delays in the XOWNA Phase 2b trial related to COVID-19 and catheter supply disruptions. HONEDRA enrollment in Japan was suspended; the company was seeking a Japanese development partner. The CLBS201 Phase 1b study had treated its first patient in April 2022, with completion of treatment for six subjects targeted for Q3 2022.
- Nasdaq had notified the company of non-compliance with its $1.00 minimum bid-price requirement. The stated deadline to regain compliance was August 17, 2022; the company said it could not sell shares under its ATM agreement until listing compliance was restored. Delisting and reduced access to capital were identified risks.
- Other risks include clinical and regulatory uncertainty, potential dilution from financing or strategic transactions, and continuing operating losses. Management reported disclosure controls were effective and no material changes in internal control over financial reporting during the quarter.
Important facts for investors to verify
- Confirm the intended issuer and period: the supplied text is Caladrius Biosciences’ Q1 2022 filing, not Lisata Therapeutics’ Q1 2021 filing.
- Track merger approvals, closing conditions, actual net cash at closing, the $10 million Cend investment, and the final ownership allocation.
- Reconcile cash runway assumptions with ongoing clinical spending, merger-related costs, and available financing; monitor Nasdaq bid-price compliance and any reverse stock split or delisting risk.
- Monitor clinical-trial enrollment, COVID-19 and supply impacts, HONEDRA partnership prospects, and CLBS201 study progress.
- Assess the sustainability of the reported loss improvement: it included a one-time tax benefit from the New Jersey NOL sale.