Filing summary
Filing identity: The request metadata identifies Lisata Therapeutics, Inc. and 2018 Q2, but the supplied filing is Caladrius Biosciences, Inc.’s Form 10-Q for the quarter ended June 30, 2019. The summary below covers the supplied filing; confirm the intended company and period.
Business context and reporting period
Caladrius is a development-stage biopharmaceutical company. Its principal programs use CD34+ cell therapy for critical limb ischemia (CLBS12), coronary microvascular dysfunction (CLBS16), and refractory angina (CLBS14). The filing reports the three and six months ended June 30, 2019, compared with the same 2018 periods; balance-sheet comparisons are with December 31, 2018. Financial statements are unaudited.
Key financial metrics
Amounts below are in millions of dollars, except per-share data. The filing reports no revenue line; it presents operating expenses and investment income.
| Metric | Q2 2019 | Q2 2018 | Six months 2019 | Six months 2018 |
|---|---|---|---|---|
| Revenue | No revenue reported | No revenue reported | No revenue reported | No revenue reported |
| Research and development expense | $2.988 | $2.123 | $5.026 | $4.385 |
| General and administrative expense | $2.358 | $2.146 | $4.912 | $5.043 |
| Total operating expense | $5.346 | $4.269 | $9.938 | $9.428 |
| Operating loss | $(5.346) | $(4.269) | $(9.938) | $(9.428) |
| Net loss | $(5.137) | $(4.077) | $(9.502) | $(9.062) |
| Net loss per share, basic and diluted | $(0.49) | $(0.42) | $(0.93) | $(0.95) |
| Operating cash used | Not presented quarterly | Not presented quarterly | $(10.205) | $(12.184) |
At June 30, 2019, cash and cash equivalents were $11.754 million and marketable securities were $21.901 million, or $33.655 million combined. Working capital was approximately $29.1 million; total liabilities were $6.728 million, including $1.171 million of operating lease liabilities. The filing reports no interest expense for the first half of 2019 and no outstanding notes payable. Total assets were $36.350 million, and total stockholders’ equity was $29.622 million. Profit margins are not meaningful given the absence of reported revenue and continuing losses.
Material changes versus the prior comparable period
- Second-quarter net loss widened to $5.137 million from $4.077 million; first-half net loss widened to $9.502 million from $9.062 million.
- Second-quarter operating expenses rose 25% to $5.346 million, mainly reflecting a 41% increase in R&D expense. First-half operating expenses rose 5%; R&D increased 15%, while G&A declined 3%.
- First-half operating cash use improved to $10.205 million from $12.184 million. The filing attributes cash changes partly to movements in operating assets and liabilities.
- Cash plus marketable securities declined to $33.655 million from $43.053 million at year-end 2018, while cash and cash equivalents alone increased to $11.754 million from $10.299 million. Marketable securities were converted or used during the period; investing activities provided $10.752 million net.
- Common shares outstanding increased to 10.413 million from 9.866 million at year-end 2018. First-half financing included approximately $1.038 million net proceeds from common-stock issuance, including the initial Lincoln Park purchase.
Outlook, management commentary, risks, and unusual items
- Management stated that existing cash was expected to fund operating expenses for at least 12 months after the financial statements’ issuance. Completion of the CLBS14 Phase 3 program depends on obtaining additional capital.
- The company may seek funding through equity or debt offerings, partnerships, collaborations, asset sales, and grants. Management cautioned that financing may not be available on acceptable terms or at all; equity financing could dilute shareholders.
- In March 2019, Caladrius entered a 36-month purchase agreement with Lincoln Park for up to $26 million of common stock, subject to conditions and limits. The company also had an at-the-market agreement with H.C. Wainwright, with an aggregate offering amount of up to $25 million; no shares were sold under that agreement in the first half of 2019.
- The CLBS03 T-Rex trial’s primary endpoint of C-peptide preservation was not achieved, although the therapy was reported as well tolerated. Further development decisions were pending analysis, including two-year follow-up data expected in early 2020.
- Management described early observations in the open-label CLBS12 and CLBS16 studies as encouraging, while emphasizing that outcomes depend on complete study data. These are preliminary observations, not established efficacy findings.
- The company recognized $1.3 million of CIRM funding as a reduction to R&D expense in the first half of 2019. It adopted the new lease accounting standard in January 2019, recording $1.4 million of lease liabilities and $1.3 million of right-of-use assets; management said the adoption had no material financial-statement impact.
- The filing reports no material changes to previously disclosed risk factors or legal proceedings, and no material adverse effect expected from pending claims. Key risks include clinical and regulatory uncertainty, trial enrollment and timing, capital availability, licensing obligations, and potential dilution.
Important facts for investors to verify
- Whether the intended filing is this Caladrius Biosciences 2019 Q2 report or a Lisata Therapeutics 2018 Q2 report.
- Cash runway assumptions and the funding required for CLBS14 Phase 3 development and other planned trials.
- Remaining availability and share-issuance limits under the Lincoln Park and H.C. Wainwright arrangements, and their potential dilutive impact.
- Complete clinical data and timelines for CLBS12 and CLBS16, and the full T-Rex follow-up analysis for CLBS03.
- The amount and timing of future research spending, CIRM funding recognition, and any license-related milestones or obligations.