Acrivon Therapeutics(ACRV) - 2024 Q1 - Quarterly Results

Business Highlights Acrivon reported significant progress in Q1 2024, highlighted by the prospective validation of its AP3 patient selection platform for the ACR-368 trial, which showed a 50% confirmed overall response rate (ORR) in OncoSignature-positive patients with ovarian and endometrial cancer, and strengthened its financial position with a $130 million oversubscribed private placement - Achieved statistically significant prospective validation of the AP3 patient selection platform with the ACR-368 OncoSignature assay, which effectively identifies cancer patients likely to respond to ACR-368 monotherapy[1] - In the ongoing Phase 2b trial of ACR-368 for platinum-resistant ovarian or endometrial cancer, a confirmed Overall Response Rate (ORR) of 50% was observed in the prospectively-defined, OncoSignature-positive patient cohort, clearly segregating responders from the OncoSignature-negative arm (0% ORR), with a p-value of 0.0038[2][3] - Successfully executed an oversubscribed $130 million private placement financing at a premium, with support from new and existing healthcare investors[1][3] Pipeline and Future Outlook The company has accelerated the development of ACR-2316, a dual WEE1/PKMYT1 inhibitor, with an IND submission planned for Q3 2024 and a Phase 1 study initiation in Q4 2024, with further pipeline updates expected in the second half of 2024 and plans to advance a new cell cycle program in 2025 - The timeline for ACR-2316, a potential first-in-class WEE1/PKMYT1 inhibitor, has been accelerated based on compelling preclinical data showing superior activity[1][3] - Key upcoming milestones for 2024 include: - IND submission for ACR-2316 in Q3 2024 - Initiation of a Phase 1 clinical study of ACR-2316 in Q4 2024 - General pipeline and corporate updates in the second half of 2024[4] - The company plans to advance a new, potential first-in-class cell cycle program for an undisclosed target towards development candidate nomination in 2025[4] First Quarter 2024 Financial Results For the first quarter of 2024, Acrivon reported a net loss of $16.5 million, an increase from $12.8 million in the prior year's quarter, driven by higher R&D and G&A expenses, and as of March 31, 2024, the company held $110 million in cash and equivalents, which, combined with a subsequent $130 million financing, is expected to fund operations into the second half of 2026 Q1 2024 Statement of Operations Highlights (vs. Q1 2023) | Financial Metric | Q1 2024 (in thousands) | Q1 2023 (in thousands) | Change | | :--- | :--- | :--- | :--- | | Research and Development | $11,473 | $9,758 | +17.6% | | General and Administrative | $6,195 | $4,635 | +33.7% | | Net Loss | $(16,486) | $(12,756) | +29.2% | | Net Loss Per Share | $(0.73) | $(0.58) | +25.9% | - The increase in R&D expenses was primarily due to the continued development of ACR-368 and increased personnel costs, while the rise in G&A expenses was mainly due to higher personnel costs, including non-cash stock compensation[5] Balance Sheet and Cash Position | Metric | As of March 31, 2024 | Note | | :--- | :--- | :--- | | Cash, Cash Equivalents & Marketable Securities (in millions) | $110 | Prior to April 2024 financing | | April 2024 Private Placement (gross proceeds, in millions) | $130 | Not included in March 31 balance | | Cash Runway | Into 2H 2026 | Includes proceeds from financing | Company Overview Acrivon is a clinical-stage biopharmaceutical company focused on precision oncology, utilizing its proprietary proteomics platform, AP3, to match patients with targeted therapies, with its lead candidate, ACR-368, in a Phase 2 trial for ovarian and endometrial cancer and having received FDA Fast Track designation, while its preclinical pipeline includes ACR-2316 and another undisclosed cell cycle program - Acrivon's core technology is its proprietary Acrivon Predictive Precision Proteomics (AP3) platform, used to identify patients most likely to benefit from its drug candidates by creating drug-specific OncoSignature companion diagnostics[7] - The lead candidate, ACR-368 (prexasertib), is a selective CHK1/CHK2 inhibitor in a potentially registrational Phase 2 trial, having received FDA Fast Track designation for use in patients with platinum-resistant ovarian or endometrial cancer identified via its OncoSignature test[7] - The preclinical pipeline includes ACR-2316, a potent and selective WEE1/PKMYT1 inhibitor, and an undisclosed cell cycle program, both developed using the AP3 platform[7]