ACRV 8-K
Acrivon Therapeutics, Inc. (ACRV)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results of Operations and Financial Condition.
On May 13, 2026, Acrivon Therapeutics, Inc., or the Company, issued a press release announcing its financial results for the quarter ended March 31, 2026, and providing business updates. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information contained in this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing with the Securities and Exchange Commission made by the Company, regardless of any general incorporation language in such filings.
Item 9.01 Financial Statements and Exhibits.
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Description |
99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Acrivon Therapeutics, Inc. |
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Date: |
May 13, 2026 |
By: |
/s/ Peter Blume-Jensen |
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Name: Peter Blume-Jensen, M.D., Ph.D. |
Exhibit 99.1
Acrivon Reports First Quarter 2026 Financial Results and Highlights Progress Towards Key 2026 Clinical Catalysts
The registrational intent ACR-368 Phase 2b study is advancing with a prespecified simultaneous interim analysis and data update for both all-comer (biopsy-independent) serous endometrial cancer arms in second half 2026
The ACR-2316 Phase 1/2 study is advancing towards expansion phase demonstrating favorable tolerability, primarily transient neutropenia, with durable clinical activity at weekly dosing regimens in subjects with AP3-prioritized tumors, including heavily pretreated lung cancers
Cash, cash equivalents, and marketable securities of $97.7 million as of March 31, 2026, plus proceeds of $7.3 million from subsequent equity financing, expected to fund operations into third quarter of 2027 and through multiple anticipated clinical milestones
WATERTOWN, Massachusetts, May 13, 2026 – Acrivon Therapeutics, Inc. (“Acrivon” or “Acrivon Therapeutics”) (Nasdaq: ACRV), a clinical stage biotechnology company discovering and developing precision medicines utilizing its proprietary Generative Phosphoproteomics AP3 (Acrivon Predictive Precision Proteomics) platform deployed for rational drug design and predictive clinical development, today reported financial results for the first quarter ended March 31, 2026 and reviewed recent business highlights.
“2026 is an important catalyst year for Acrivon as we advance our two differentiated, AP3-guided clinical oncology programs towards key data read-outs,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president and co-founder of Acrivon. “For ACR-368, we are increasingly focused on serous endometrial cancer, a disease with high unmet need contributing upwards of 50% of all endometrial cancer deaths every year. This focus is supported by the compelling clinical activity observed thus far and the enthusiastic endorsement by external KOLs. We are particularly excited by the prospect of rapid enrollment of the serous population in our Phase 2b study in the U.S. and EU given that there is no requirement for a biopsy. Given the accelerated enrollment, we are now planning to conduct a pre-specified simultaneous interim analysis of both Arms 3 and 4 in second half of 2026. In parallel, we continue advancing ACR-2316 which has shown exciting initial clinical activity in AP3-prioritized tumor types, including lung cancers which are traditionally not sensitive to WEE1 inhibitors. With cash runway expected into the third quarter of 2027, we believe we are well positioned to execute through multiple potential value-inflection milestones.”
Recent Highlights
ACR-368: CHK1 / CHK2 Inhibitor
ACR-2316: WEE1 / PKMYT1 Inhibitor
CDK11 Inhibitor Program
Anticipated Upcoming Milestones
ACR-368 Ongoing Registrational Intent Phase 2b Study
Broader Pipeline
First Quarter 2026 Financial Results
Net loss for the quarter ended March 31, 2026 was $19.0 million compared to a net loss of $19.7 million for the same period in 2025.
Research and development expenses were $15.2 million for the quarter ended March 31, 2026 compared to $15.4 million for the same period in 2025, which is materially consistent.
General and administrative expenses were $4.7 million for the quarter ended March 31, 2026, compared to $6.2 million for the same period in 2025. The difference was primarily due to a decrease in employee-related expenses including stock-based compensation.
As of March 31, 2026, the company had cash, cash equivalents and investments of $97.7 million which, together with the net proceeds raised from subsequent equity financing, is expected to fund operating expenses and capital expenditure requirements into the third quarter of 2027.
About Acrivon Therapeutics
Acrivon is a clinical stage biopharmaceutical company discovering and developing precision medicines utilizing its proprietary Generative Phosphoproteomics AP3 platform. The platform allows the company to interpret and quantify compound specific, drug-regulated pathway activity levels inside the intact cell in an unbiased manner, yielding terabytes of proprietary data and
delivering rapid, actionable insights. The Generative Phosphoproteomics AP3 platform is comprised of a growing suite of powerful, internally-developed tools, including the AP3 Data Portal, converting multimodal data into structured data for generative AI analyses, the AP3 Kinase Substrate Relationship Predictor and the AP3 Interactome. These distinctive capabilities enable the company to go beyond the limitations of traditional drug discovery, as well as current AI-based target-centric drug discovery and rapidly design highly differentiated compounds with desirable pathway effects through intracellular protein network analyses and advance these agents into the clinic for streamlined development.
Acrivon is currently advancing its lead program, ACR-368 (also known as prexasertib), a selective small molecule inhibitor targeting CHK1 and CHK2 in a potentially registrational Phase 2 trial for endometrial cancer. The company has received Fast Track designation from the Food and Drug Administration, or FDA, for the investigation of ACR-368 as a monotherapy based on OncoSignature-predicted sensitivity in patients with endometrial cancer. The FDA has granted a Breakthrough Device designation for the ACR-368 OncoSignature assay for the identification of patients with endometrial cancer who may benefit from ACR-368 treatment.
In addition to ACR-368, Acrivon is also leveraging its proprietary Generative AI-driven Phosphoproteomics AP3 platform for developing its co-crystallography-driven, internally discovered pipeline programs. These include ACR-2316, the company’s second clinical stage asset, a novel, potent, selective WEE1/PKMYT1 inhibitor designed for superior single-agent activity through strong activation of not only CDK1 and CDK2, but also of PLK1 to drive pro-apoptotic cell death, as observed in preclinical studies against benchmark inhibitors. The Phase 1 trial of ACR-2316 is advancing, with weekly dosing regimens established. Initial data has shown a favorable tolerability profile limited to transient, mechanism-based hematological adverse events, predominantly neutropenia and initial clinical activity across AP3-selected solid tumor types, including PRs in endometrial cancer, as well as SCLC and sqNSCLC, two tumor types which have not shown sensitivity to other clinical WEE1 or PKMYT1 inhibitors currently in development. In addition, the company is advancing ACR-6840, and other potential development candidates, targeting CDK11.
Forward-Looking Statements
This press release includes certain disclosures that contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release, including statements regarding our future results of operations or financial condition, business strategy and plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these words or other similar terms or expressions. Forward-looking statements are based on Acrivon’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties that are described more fully in the section titled “Risk Factors” in our reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this press release are made as of this date, and Acrivon undertakes no duty to update such information except as required under applicable law.
Acrivon intends to use its website as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD. For more information, please visit www.acrivon.com.
Investor and Media Contacts:
Adam D. Levy, Ph.D., M.B.A.
[email protected]
Alexandra Santos
[email protected]
Acrivon Therapeutics, Inc. |
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March 31, |
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December 31, |
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2026 |
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2025 |
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Assets |
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Cash and cash equivalents |
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$ |
34,064 |
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$ |
41,499 |
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Investments |
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63,673 |
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77,083 |
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Other assets |
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10,095 |
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11,135 |
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Total assets |
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$ |
107,832 |
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$ |
129,717 |
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Liabilities and Stockholders' Equity |
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Liabilities |
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$ |
12,317 |
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$ |
17,201 |
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Stockholders' Equity |
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95,515 |
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112,516 |
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Total Liabilities and Stockholders' Equity |
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$ |
107,832 |
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$ |
129,717 |
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Acrivon Therapeutics, Inc. |
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Three Months Ended March 31, |
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2026 |
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2025 |
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Operating expenses: |
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Research and development |
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$ |
15,166 |
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$ |
15,414 |
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General and administrative |
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4,736 |
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6,248 |
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Total operating expenses |
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19,902 |
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21,662 |
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Loss from operations |
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(19,902 |
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(21,662 |
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Other income (expense), net: |
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Interest income |
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989 |
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1,996 |
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Other expense, net |
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(129 |
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(14 |
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Total other income, net |
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860 |
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1,982 |
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Net loss |
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$ |
(19,042 |
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$ |
(19,680 |
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Net loss per share - basic and diluted |
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$ |
(0.49 |
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$ |
(0.51 |
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Weighted-average common stock outstanding - basic and diluted |
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38,724,803 |
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38,350,444 |
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Comprehensive loss: |
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Net loss |
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$ |
(19,042 |
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$ |
(19,680 |
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Other comprehensive loss: |
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Unrealized loss on available-for-sale investments, net of tax |
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(107 |
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(164 |
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Comprehensive loss |
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$ |
(19,149 |
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$ |
(19,844 |
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