CalciMedica, Inc. — Q3 2023 Form 10-Q
Reporting period: Quarter and nine months ended September 30, 2023. Amounts are in U.S. dollars; financial statement figures are in millions unless otherwise noted.
Business context and reporting period
CalciMedica is a clinical-stage biopharmaceutical company developing CRAC-channel inhibitors for serious inflammatory illnesses. Its lead candidate, intravenous Auxora (zegocractin), is being studied in acute pancreatitis (AP), asparaginase-induced pancreatic toxicity (AIPT), and other indications. The company has no approved products and has generated no product revenue.
The March 20, 2023 merger with Graybug Vision was accounted for as a reverse recapitalization, with Private CalciMedica as accounting acquirer. Accordingly, pre-merger comparative periods reflect Private CalciMedica on a standalone basis, while 2023 results include Graybug activity from March 21 onward. Comparisons are therefore affected by the transaction and are not fully like-for-like.
Key financial metrics
| Metric | Three months ended September 30, 2023 | Nine months ended September 30, 2023 |
|---|---|---|
| Revenue | None reported | None reported |
| Research and development expense | $2.772 | $13.077 |
| General and administrative expense | $2.061 | $20.679 |
| Total operating expenses | $4.833 | $33.756 |
| Net loss | $4.619 | $30.211 |
| Net loss per share, basic and diluted | $0.82 | $7.43 |
| Net cash used in operating activities | $22.118 for the nine-month period |
For the comparable 2022 periods, quarterly net loss was $2.581 million and nine-month net loss was $9.241 million. Gross margin and profitability margins are not meaningful because the company reported no revenue.
At September 30, 2023, cash and cash equivalents were $11.644 million and short-term investments were $2.947 million, totaling approximately $14.6 million. Current assets were $15.273 million and current liabilities $3.686 million. Total liabilities were $3.686 million; convertible promissory notes and warrant liabilities had been converted or reclassified, leaving no such balances at quarter-end. Accumulated deficit was $141.918 million.
Operating cash use was $22.118 million, versus $7.668 million in the prior-year nine-month period. Investing activities provided $11.561 million, primarily reflecting investment maturities, while financing activities provided $20.725 million, including merger cash and private-placement proceeds, offset by transaction costs. Cash and cash equivalents increased by $10.168 million during the period.
Material changes versus prior comparable periods
- Quarterly operating expenses increased 47% to $4.833 million and net loss increased 79% to $4.619 million year over year; quarterly R&D rose 123%, largely due to higher personnel, clinical and manufacturing-related costs.
- Nine-month operating expenses rose to $33.756 million from $11.088 million, and net loss increased to $30.211 million from $9.241 million. The comparison includes merger-related changes and one-time costs.
- Nine-month 2023 expenses included $16.2 million of one-time merger-related charges: $10.5 million for accelerated vesting of Graybug stock awards and $5.7 million for severance. Stock-based compensation totaled $12.071 million.
- Other income was $3.545 million for the nine-month period, including $3.168 million of gains from fair-value changes in financial instruments; these non-cash gains reduced reported net loss.
- The company raised approximately $10.3 million gross in a private placement around the merger. Its ATM facility had generated $72,000 net by September 30, with $4.6 million still available; $99.9 million remained available under the broader $100 million shelf registration statement.
Outlook, risks and unusual items
- Management estimated existing cash, cash equivalents and short-term investments would fund operations through the third quarter of 2024, but would not fund development through regulatory approval. The filing states that resources may not cover the one-year period following issuance of the financial statements and identifies substantial doubt about the company’s ability to continue as a going concern.
- The company expects continuing losses and rising R&D and public-company costs. It plans to seek additional financing, collaborations, licensing or other funding; availability and terms are uncertain and equity financing may dilute shareholders.
- Management expected topline results from the Phase 2b CARPO AP trial in the first half of 2024. It expected first-cohort CRSPA data to be published in Q4 2023 and planned an AKI IND submission in Q4 2023, with a possible Phase 2 trial in the first half of 2024 subject to funding.
- Key risks include clinical-trial outcomes and enrollment, regulatory acceptance of data from trials in India, reliance on contract manufacturers and research vendors, funding needs, competition, intellectual-property protection, and the possibility that Auxora or other candidates will not obtain approval.
- Disclosure controls were reported ineffective due to a material weakness in review of valuation inputs and assumptions for convertible notes and warrants. Remediation was underway, but management gave no assurance it would succeed. The weakness had resulted in restatement of 2022 financial statements; management reported additional analysis for this filing and stated the included statements fairly present the periods shown.
- The company reported no material subsequent events through November 9, 2023 and no pending litigation believed likely to have a material adverse effect.
Most important facts for investors to verify
- Whether CARPO results and the stated clinical timelines were achieved, and what the final data show.
- Current cash runway, spending assumptions, and progress in securing financing beyond the estimated Q3 2024 runway.
- Whether the material weakness has been remediated and whether subsequent filings identify further control deficiencies or restatements.
- Actual use of the ATM and shelf capacity, potential dilution, and the number of shares outstanding; the filing reported 5,684,873 shares outstanding as of November 6, 2023.
- Whether clinical-trial, manufacturing, regulatory, or funding developments materially change the company’s development plans or going-concern assessment.