Matinas BioPharma Holdings, Inc. — Q2 2023 Form 10-Q
Reporting period: Three and six months ended June 30, 2023. Dollar amounts below are in millions unless noted. Matinas is a clinical-stage biopharmaceutical company developing products using its lipid nanocrystal (LNC) delivery platform; it has no approved products and no product-sale revenue.
Business context and development
- The company’s lead candidate is MAT2203, oral amphotericin B, which it is advancing toward an initial indication involving cryptococcal meningitis. Management is seeking non-dilutive funding and FDA input on a potential additional Phase 3 study for invasive fungal infections.
- Development of MAT2501 was paused after the company determined in 2022 that continuing was not commercially reasonable. The company expects no further Cystic Fibrosis Foundation award payments and has no further obligations under that award.
- Other priorities include expanding the LNC platform into nucleic-acid delivery and pursuing collaborations. The BioNTech agreement expired April 8, 2023; the company completed its remaining Genentech feasibility-study obligation during the first half.
Financial results and liquidity
| Metric | Q2 2023 | Q2 2022 | Six months 2023 | Six months 2022 |
|---|---|---|---|---|
| Contract revenue | $0 | $1.063 | $1.096 | $1.063 |
| Research and development | $3.559 | $4.127 | $7.530 | $9.105 |
| General and administrative | $2.600 | $2.861 | $5.311 | $5.606 |
| Net loss | $6.060 | $5.923 | $11.573 | $11.901 |
| Net loss per share | $0.03 | $0.03 | $0.05 | $0.06 |
- Contract revenue is collaboration/research revenue, not product sales. The filing reports no meaningful product gross margin; operating results remain loss-making.
- At June 30, 2023, cash and cash equivalents were $9.743 and marketable debt securities were $12.770, totaling $22.513; restricted cash was $0.250. Current assets were $24.000 and current liabilities $2.589.
- Total liabilities were $6.171, including $3.829 of operating lease liabilities and $0.025 of finance lease liabilities. No conventional financial borrowings are reported.
- For the first half, operating cash use was $6.280, versus $9.887 in 2022. Investing activities provided $9.198, primarily reflecting proceeds from maturities of marketable securities; financing activities used $0.005. Cash, cash equivalents and restricted cash increased $2.913.
- Accumulated deficit was $164.204. The company had 217.3 million common shares outstanding at June 30 and reported no warrants outstanding.
Changes, outlook and risks
- Q2 net loss increased slightly year over year despite lower R&D and G&A expenses, mainly because Q2 2022 included $1.063 of contract revenue while Q2 2023 had none. First-half net loss improved modestly, while expenses declined. A $1.734 sale of New Jersey tax losses and credits benefited first-half 2022 but did not recur in 2023.
- Management expects 2023 R&D expense to be lower than 2022, reflecting the MAT2501 pause and focus on MAT2203 and the LNC platform; G&A expense is expected to remain relatively consistent. It also anticipates lower operating cash use during the remainder of 2023.
- Management estimates available cash and marketable securities will fund planned operations into the third quarter of 2024, but not beyond. The filing states that substantial doubt exists about the company’s ability to continue as a going concern. Continued operations depend on expense control and obtaining additional capital, including possible ATM sales, equity or debt financing, government funding, collaborations or licensing; availability and terms are uncertain.
- Key risks include clinical, regulatory, manufacturing and funding uncertainties; dependence on third parties and licensed LNC technology; potential dilution or unfavorable financing terms; and the possibility of delaying or ending development if funding is unavailable. The filing reports no material changes to the risk factors in the 2022 Form 10-K, no legal proceedings, and no off-balance-sheet arrangements.
- Disclosure note: The MD&A narrative gives first-half 2023 G&A expense as $5.443, inconsistent with the financial statements and MD&A table, both of which report $5.311. The financial-statement figure is used above; investors may wish to verify the discrepancy.
Important facts for investors to verify
- Whether financing or non-dilutive funding is secured to extend the stated runway beyond Q3 2024, and the potential dilution or terms involved.
- MAT2203’s clinical and regulatory path, including timing, funding, and FDA feedback on any further Phase 3 study.
- Whether collaboration activity can generate meaningful future funding or revenue following the BioNTech agreement’s expiration and completion of the Genentech study.
- The reported first-half G&A discrepancy and the cash-burn assumptions underlying management’s runway estimate.