Immix Biopharma, Inc. — FY2022 Form 10-K
Reporting period: Fiscal year ended December 31, 2022; filed March 27, 2023. This is an annual report, not a standalone fourth-quarter results filing. The company is a clinical-stage biopharmaceutical developer with two units: ImmixBio, focused on solid tumors and inflammatory diseases, and majority-owned Nexcella, developing cell therapies for blood cancers. It reported no revenue from operations.
Financial performance and liquidity
| Metric | FY2022 / Dec. 31, 2022 | FY2021 / Dec. 31, 2021 |
|---|---|---|
| Revenue | None | None |
| General and administrative expense | $4.02 million | $1.23 million |
| Research and development expense | $4.20 million | $0.13 million |
| Operating loss | $8.22 million | $1.35 million |
| Net loss | $8.23 million | $24.38 million |
| Net cash used in operating activities | $7.41 million | $1.59 million |
| Cash | $13.44 million | $17.64 million |
| Total assets | $14.91 million | $18.19 million |
| Total liabilities | $1.75 million | $0.20 million |
| Accumulated deficit | $37.99 million | $29.76 million |
Gross profit and operating margins are not meaningful because the company had no revenue. Net loss per share was $0.59 in 2022 versus $6.64 in 2021. The 2021 loss included a $22.76 million non-cash charge from remeasuring embedded derivatives in convertible notes; the notes converted to equity at the December 2021 IPO. No note payable remained on the year-end 2022 balance sheet. The filing does not disclose a conventional debt balance outstanding at year-end.
Cash declined by $4.21 million during 2022. Financing activities provided $3.23 million, principally including $2.91 million of net proceeds from the IPO underwriters’ over-allotment and $475,000 received for Nexcella’s private offering. Current assets were $14.90 million against current liabilities of $1.27 million, in addition to $475,000 of funds held for the subsidiary offering. The company reported no credit facility or committed source of additional capital.
Material changes versus the prior year
- Operating expenses rose to $8.22 million from $1.35 million, reflecting substantially higher clinical-trial and development spending, the $1.5 million upfront Nexcella license fee, and higher public-company costs.
- Net loss narrowed from $24.38 million to $8.23 million, primarily because the prior-year derivative remeasurement charge did not recur; operating loss itself increased materially.
- Operating cash use increased to $7.41 million from $1.59 million as clinical activity expanded.
- Cash fell from $17.64 million to $13.44 million. Nexcella was formed in 2022, and the company reported owning 98% of it after a January 2023 private placement.
Pipeline, outlook and significant items
- IMX-110: Phase 1b/2a studies in advanced solid tumors, including soft tissue sarcoma (STS), in the U.S. and Australia. The filing describes 17 treated trial patients and interim STS results including a 4-month median progression-free survival and 6-month radiological PFS in 50% of STS patients. Only eight patients had completed post-enrollment tumor measurements in the cited interim dataset. The company reported no drug-related serious adverse events or toxicity-related dose interruptions to date. These are early, limited clinical observations, not established efficacy.
- The company planned to enroll about 30 additional STS patients in a Phase 2a study, with first dosing anticipated in 2023 and an estimated 24-month duration after dosing began; it subsequently planned an 80-patient Phase 2b/3 study. IMX-110 had FDA Orphan Drug Designation for STS and Rare Pediatric Disease Designation for rhabdomyosarcoma; designations do not assure approval or a faster review.
- IMX-111 and IMX-120: Preclinical candidates for advanced colorectal cancer and inflammatory bowel disease, respectively. The company planned IND-enabling work and anticipated IND filings in the first half of 2024, with initial patient dosing also anticipated in 2024.
- NXC-201: Nexcella’s Phase 1b/2a autologous BCMA CAR-T candidate for relapsed/refractory multiple myeloma (MM) and AL amyloidosis (ALA). At the therapeutic dose, interim MM data for 29 patients showed a 90% overall response rate and 59% complete or stringent complete response rate. Five published ALA patients had reported 100% hematologic complete response and organ response rates; the filing also says eight ALA patients had been treated by February 2023. These small, early-stage datasets require further follow-up and confirmation. The company planned to enroll approximately 100 MM patients and 30–40 ALA patients at the recommended Phase 2 dose, and targeted its first NXC-201 BLA filing for the first half of 2025.
- Funding and licensing: Nexcella’s December 2022 license agreement carries approximately $13 million in additional quarterly payments through September 2026, annual license fees, 5% royalties on licensed-product net sales, potential sales milestones of up to $20 million, and an estimated $13 million commitment to fund clinical trials in Israel over four years. These commitments could materially increase funding needs.
- Subsequent financing: On March 22, 2023, Immix entered an at-the-market agreement allowing up to $5 million of common-stock sales, subject to applicable limitations, with a 3.75% sales commission. This offers a potential funding source but could dilute existing shareholders.
- Going concern and outlook: The company has recurring losses, no product revenue, and expects continued losses and substantial additional financing needs. Management said cash on hand at December 31, 2022, together with funds available through the ATM, was expected to cover working-capital needs through at least March 27, 2024, while warning that plans and cash needs could change. The filing emphasizes that financing may not be available on acceptable terms.
- Controls and contingencies: Management identified a material weakness in internal control over financial reporting, citing limited personnel and insufficient formal transaction-review procedures. It added accounting consultants but gave no assurance remediation would be sufficient. Management concluded the financial statements were fairly presented; the auditor issued an unqualified opinion on the statements but did not audit or attest to internal-control effectiveness. The company reported no material pending litigation.
Key risks and investor verification points
- Verify cash runway, actual cash burn, subsequent ATM proceeds, and the timing and terms of any additional financing; the company’s development plans depend on raising capital.
- Track enrollment, follow-up, safety, and efficacy in the IMX-110 and NXC-201 trials. Pay particular attention to small interim sample sizes, evaluable-patient counts, durability, and whether results are independently confirmed.
- Assess whether NXC-201’s planned U.S. trial and regulatory path support the targeted BLA timing, and whether outpatient-treatment assumptions are demonstrated clinically and accepted by regulators.
- Monitor Nexcella’s license payments, trial-funding obligations, royalties and milestones, and the impact of its financing and related-party arrangements on Immix shareholders.
- Check progress in remediating the material weakness and whether disclosure controls and financial reporting remain reliable.
- Consider risks from clinical failure or delay, regulatory approval, patient enrollment, third-party manufacturing and trial providers, competition, intellectual-property disputes, reimbursement, and potential stock dilution. The company also notes that a substantial portion of Immix shares is held by insiders and affiliates.