Acrivon Therapeutics, Inc. — FY2023 Form 10-K
Reporting period: Fiscal year ended December 31, 2023. This is an annual report; it does not provide a separate Q4 financial result. Acrivon is a clinical-stage oncology company with no approved products and no product-sales revenue.
Business context and development
Acrivon’s AP3 proteomics platform is intended to identify patients whose tumors may respond to specific cancer drugs, using drug-specific OncoSignature tests. Its lead candidate, ACR-368 (prexasertib), is in Phase 2 trials for platinum-resistant ovarian, endometrial and bladder cancers. OncoSignature-positive patients receive ACR-368 alone; patients testing negative are being studied with ACR-368 plus low-dose gemcitabine. ACR-2316, a dual WEE1/PKMYT1 inhibitor, is in IND-enabling studies, with IND submission anticipated in Q4 2024. A further cell-cycle program has an anticipated development-candidate nomination in 2025.
Financial results and liquidity
| Metric | FY2023 | FY2022 |
|---|---|---|
| Revenue | None | None |
| Research and development expense | $46.0 million | $23.9 million |
| General and administrative expense | $21.1 million | $8.7 million |
| Total operating expenses | $67.1 million | $32.7 million |
| Other income, net | $6.7 million | $1.5 million |
| Net loss | $60.4 million | $31.2 million |
| Net loss per share, basic and diluted | $2.74 | $7.56 |
| Net cash used in operating activities | $42.6 million | $30.1 million |
Operating margins are not meaningful because the company had no revenue. The lower loss per share year over year reflects, in part, the much higher weighted-average share count after the 2022 IPO; it does not indicate profitability.
At December 31, 2023, cash and cash equivalents were $36.0 million and short-term investments were $91.4 million, for total cash, cash equivalents and investments of $127.5 million. Total assets were $138.3 million, total liabilities $17.1 million, and stockholders’ equity $121.2 million. The balance sheet reports no borrowings; operating lease liabilities totaled $4.6 million. The company estimates its available funds will support operating expenses and capital expenditures into Q4 2025, subject to assumptions and the possibility of needing funds sooner.
Material changes versus FY2022
- Net loss increased by $29.2 million, while operating expenses rose by $34.4 million.
- R&D expense increased by $22.1 million, primarily from ACR-368 trial activity, including Akoya milestones, added personnel, and advancement of ACR-2316 and other discovery work.
- G&A expense increased by $12.4 million, including higher employee-related costs and public-company expenses.
- Other income increased by $5.2 million, mainly from interest income and investment accretion.
- Operating cash use increased by $12.5 million. The 2023 cash-flow increase also reflected investment maturities and purchases; financing cash flow was a $1.6 million use, compared with IPO-related inflows in 2022.
Outlook, risks and notable items
- Management expects continued operating losses and increasing development costs; the filing gives no revenue or earnings guidance.
- Management reported encouraging initial clinical observations announced in November 2023, but emphasized these were based on limited patients. More mature ACR-368 monotherapy and combination data were expected in the first half of 2024. The company planned to consider registrational development after the OncoSignature-positive study’s Simon Stage 1, subject to results and FDA discussions.
- ACR-368 received Fast Track designations for OncoSignature-positive platinum-resistant ovarian and endometrial cancer. The ACR-368 OncoSignature assay received FDA Breakthrough Device Designation for ovarian cancer. Neither designation guarantees approval; the assay had not received regulatory approval.
- Material risks include clinical-trial failure or delay, patient enrollment, dependence on ACR-368 and the OncoSignature companion diagnostic, reliance on Akoya and other third parties, manufacturing and supply constraints, additional financing needs, and intellectual-property and regulatory risks. The company reported no material legal proceedings.
- Potential contractual payments include up to $168.0 million in development and commercial milestones to Lilly, including $5.0 million due before an NDA, plus tiered royalties of up to 10% on net sales. Akoya milestone payments may total up to $17.3 million; the filing reports $8.3 million paid through March 28, 2024. These amounts are contingent, not current debt.
- Stock-based compensation was $11.6 million in FY2023 versus $2.2 million in FY2022. Four previously identified material weaknesses in financial reporting controls were reported as remediated; management concluded controls were effective at December 31, 2023. The auditor did not provide an internal-control attestation.
Most important facts for investors to verify
- Whether mature clinical results confirm the preliminary activity in each tumor type and treatment arm, including response durability and safety.
- Whether OncoSignature testing is analytically and clinically validated, can support patient enrollment, and receives required regulatory approval alongside ACR-368.
- Whether the FDA accepts the proposed trial design and evidence as sufficient for registrational development or any accelerated approval pathway.
- Whether the Q4 2025 cash runway remains achievable as trial, diagnostic, manufacturing and operating costs evolve, and whether additional capital or dilution will be needed.
- Progress of ACR-2316 toward IND submission, and the timing and terms of contingent Lilly and Akoya obligations.