Calidi Biotherapeutics, Inc. — Form 10-K Summary
Reporting period: Fiscal year ended December 31, 2023; this is an annual report, not a standalone Q4 report. The business combination with First Light Acquisition Group closed September 12, 2023 and was accounted for as a reverse recapitalization, with Calidi as the accounting acquirer. Financial statements include the acquired business from the closing date.
Business context and pipeline
Calidi is a clinical-stage immuno-oncology company developing allogeneic stem-cell delivery platforms and enveloped oncolytic viruses. It has no approved products and has not generated product-sales revenue. Its programs include CLD-101 for newly diagnosed and recurrent high-grade glioma (HGG), CLD-201 for advanced solid tumors, and discovery-stage CLD-400 (RTNova) for certain lung cancers and metastatic solid tumors.
- CLD-101: A prior investigator-sponsored Phase 1 study in newly diagnosed HGG enrolled 12 patients. The filing reports the treatment was generally tolerated, with one grade 3 viral meningitis event considered probably related after inadvertent injection into a ventricle. The small, open-label, single-arm study does not establish efficacy.
- Recurrent HGG: City of Hope dosed the first patient in a Phase 1 study in May 2023; the filing says cohort 4 was enrolling beginning January 2024.
- CLD-201: Preclinical candidate; the company held an FDA pre-IND meeting and anticipated a Phase 1 trial in the second half of 2024, subject to regulatory and development progress.
Financial results and liquidity
| Metric | 2023 | 2022 |
|---|---|---|
| Revenue | $0 | $45,000 |
| Research and development expense | $13.0 million | $7.3 million |
| General and administrative expense | $16.0 million | $15.9 million |
| Operating loss | $29.0 million | $23.1 million |
| Net loss | $29.2 million | $25.4 million |
| Net loss per share, basic and diluted | $1.73 | $2.99 |
| Cash used in operating activities | $27.0 million | $13.2 million |
| Cash used in investing activities | $0.5 million | $0.5 million |
| Cash provided by financing activities | $29.0 million | $12.1 million |
- R&D expense rose 79%, principally from toxicology and manufacturing, increased headcount, the new San Diego lease, and consulting. G&A was broadly flat; lower merger-related costs offset increases in other expense categories.
- Grant income of $2.9 million from CIRM and fair-value changes affected 2023’s reported other expense. Total other expense was $0.2 million, versus $2.3 million in 2022. These items do not indicate operating profitability.
- At December 31, 2023, cash was $1.949 million; restricted cash was $0.218 million. The cash-flow statement reports combined cash and restricted cash of $2.167 million. Current assets were $4.303 million and current liabilities $10.232 million, a working-capital deficit of about $5.9 million. Total liabilities were $18.3 million; stockholders’ deficit was $8.2 million.
- Debt carrying value was about $2.9 million, including accrued interest; $0.8 million was current and $2.1 million noncurrent. Certain related-party notes carry high interest rates, including 24% on some balances. The company also reported $0.7 million of warrant liabilities.
- Operating cash use increased substantially year over year. The company reported an accumulated deficit of $99.6 million and concluded that available resources were insufficient to fund operations for at least 12 months from issuance of the financial statements. Management and the auditor identified substantial doubt about the company’s ability to continue as a going concern.
Material changes, outlook, risks and unusual items
- The September 2023 business combination converted legacy preferred stock, SAFEs and convertible notes into common stock and brought in financing, but redemptions were significant: 2.69 million public shares were redeemed for about $28.2 million. The company received limited cash from the trust; most remaining funds went to transaction-related arrangements.
- A December 2023 Standby Equity Purchase Agreement gives Calidi the option to sell up to $25 million of stock to Yorkville over 36 months, subject to conditions, registration, ownership and exchange-cap limits. Shares are priced at 97% of the defined market price. The filing does not treat the full commitment as cash already available.
- The company’s forward purchase arrangement is unlikely to yield cash at current share-price levels, according to management. Its derivative asset fell from an estimated $4.5 million at closing to $0.2 million at year-end; settlement is subject to price resets and a $2-per-share adjustment.
- After year-end, Calidi reported a $0.2 million loan at 12% and a $1.0 million convertible note at 12%. A March 2024 settlement also included a $2.0 million cash-funded convertible note and a $1.5 million note issued to settle claims. These financing terms permit conversion into stock and may dilute existing holders.
- Further financing is needed to advance clinical programs. Failure to raise capital could force delays, reductions or termination of development. Other principal risks include clinical and regulatory uncertainty, trial enrollment, manufacturing scale-up and reliance on outside manufacturers, licensing obligations, competition, and potential dilution.
- The company reported $7.3 million of manufacturing and supplier commitments, $4.4 million of future minimum lease payments, and potential license milestones and royalties. It stated that contingent license payments were not considered probable at year-end. The Northwestern license includes a best-efforts commitment to fund up to $10 million toward a Phase 2 trial; the University of Chicago/City of Hope license provides for up to $18.7 million in contingent milestones.
- Legal matters include a physician dispute settled in February 2024 for 200,000 restricted shares and 400,000 warrants exercisable at $1.32, and a former finance executive’s suit seeking $575,000 plus other damages; the company says it intends to defend the latter and seek recovery of a $150,000 bonus.
- Management said disclosure controls were effective at the reasonable-assurance level as of year-end. The company disclosed prior internal-control weaknesses at FLAG before the business combination; no auditor attestation on internal control was required. Marcum’s financial-statement opinion was unqualified and included a going-concern explanatory paragraph.
Most important facts for investors to verify
- Current cash, cash runway, burn rate, and whether subsequent financing has been sufficient to address the disclosed going-concern doubt.
- Whether Yorkville facility conditions and registration requirements are met, how much funding is actually accessible, and the dilution and pricing effects of any drawdowns.
- Clinical-trial progress, regulatory status and updated safety and efficacy data for CLD-101 and CLD-201, including whether the stated 2024 timelines were achieved.
- Outstanding debt and payment obligations, including high-interest related-party notes, supplier commitments, license obligations and post-year-end convertible notes.
- Fully diluted share count and potential dilution from warrants, options, escrowed escalation shares, registered resale shares and convertible securities.
- Outcomes and financial effects of the former finance executive litigation and other settlement obligations.