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 14, 2025, Acrivon Therapeutics, Inc., or the Company, issued a press release announcing its financial results for the quarter ended March 31, 2025, 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.
Exhibit Number |
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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 14, 2025 |
By: |
/s/ Peter Blume-Jensen |
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Name: Peter Blume-Jensen, M.D., Ph.D. |
Exhibit 99.1
Acrivon Therapeutics Reports First Quarter 2025 Financial Results and Business Highlights
Corporate R&D event highlighted positive ACR-368 data in endometrial cancer patients who had all received prior anti-PD-1 and platinum-based chemotherapy
Confirmed overall response rate (cORR) of 35% and median duration of response (mDOR) >5.6 months (not yet reached) observed in OncoSignature-positive (BM+) patients, a majority of whom were refractory to last prior therapy, and cORR of 50% and mDOR >10 months (not yet reached) for BM+ patients who had relapsed on last prior therapy
Three dose escalation cohorts completed in ACR-2316 Phase 1 trial with tumor shrinkage observed already at dose level (DL)3, below projected recommended Phase 2 dose
AACR presentation of ACR-2316 revealing mechanisms underlying its superior preclinical activity with potent mitotic tumor cell death using AP3 Generative Phosphoproteomics
Mansoor Raza Mirza, M.D. appointed chief medical officer; accomplished clinician with stellar track record of successfully leading registrational trials through regulatory approvals, and establishing new standards of care in gynecological oncology
Cash, cash equivalents and marketable securities of $164.8 million as of March 31, 2025, expected to fund operations into the second quarter of 2027
WATERTOWN, Massachusetts, May 14, 2025 – Acrivon Therapeutics, Inc. (“Acrivon” or “Acrivon Therapeutics”) (Nasdaq: ACRV), a clinical stage biotechnology company discovering and developing precision oncology medicines utilizing its proprietary Generative Phosphoproteomics AP3 (Acrivon Predictive Precision Proteomics) platform designed to interpret and quantify compound specific, drug-regulated pathway activity levels inside the intact cell in an unbiased and actionable manner, today reported financial results for the first quarter ended March 31, 2025 and reviewed recent business highlights.
“We made substantial progress in the first quarter in the advancement of our clinical pipeline and the expansion of our Generative Phosphoproteomics AP3 capabilities, as well as strengthening the executive team,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and founder of Acrivon. “At our corporate R&D event, we reported positive updated interim data from our ongoing ACR-368 Phase 2b study in endometrial cancer patients with large tumors and aggressive histopathologies – all of whom had progressed after prior platinum-based chemotherapy and anti-PD-1. With a significant unmet need for second-line treatment options and the potential for label expansion through a confirmatory trial in the front-line setting with ACR-368 used as switch maintenance, we remain very excited by the opportunities for this program. For our second clinical-stage asset, ACR-2316, we have
observed tumor shrinkage (~25%) in a patient with significant metastatic solid tumor burden after only six weeks of treatment at dose level 3 - well before reaching our projected RP2D, supporting its potential for monotherapy activity. Finally, we are thrilled and feel privileged that Dr. Mansoor Raza Mirza, a globally recognized oncologist, is now leading the development of our pipeline as CMO. Mansoor has made significant contributions in clinical oncology as a lead investigator for multiple approved drugs and senior author of national cancer guidelines.”
Recent Highlights
Anticipated Upcoming Milestones
First Quarter 2025 Financial Results
Net loss for the quarter ended March 31, 2025 was $19.7 million compared to a net loss of $16.5 million for the same period in 2024.
Research and development expenses were $15.4 million for the quarter ended March 31, 2025 compared to $11.5 million for the same period in 2024. The difference was primarily due to the continued execution of the clinical trials for ACR-368 and ACR-2316, as well as preclinical drug discovery advancement and increased personnel to support these research and development activities.
General and administrative expenses were $6.2 million for the quarter ended March 31, 2025, which is materially consistent with the same period in 2024.
As of March 31, 2025, the company had cash, cash equivalents and investments of $164.8 million, which is expected to fund operating expenses and capital expenditure requirements into the second quarter of 2027.
About Acrivon Therapeutics
Acrivon is a clinical stage biopharmaceutical company discovering and developing precision oncology 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 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 enrollment in the first three dose-escalation cohorts completed. Drug target engagement was observed at DL1 and 2 using the company’s clinical mass-spectrometry-based AP3 profiling, with evidence of approximate dose proportionality based on plasma pharmacokinetic analyses, and initial clinical activity with tumor shrinkage observed at DL3. The company also has a preclinical cell cycle program with an undisclosed target.
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, preclinical and clinical results, 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.
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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Three Months Ended March 31, |
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2025 |
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2024 |
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Operating expenses: |
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Research and development |
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$ |
15,414 |
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$ |
11,473 |
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General and administrative |
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$ |
6,248 |
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$ |
6,195 |
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Total operating expenses |
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21,662 |
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17,668 |
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Loss from operations |
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(21,662 |
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(17,668 |
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Other income (expense), net: |
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Interest income |
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1,996 |
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1,446 |
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Other expense, net |
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(14 |
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(264 |
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Total other income, net |
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1,982 |
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1,182 |
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Net loss |
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$ |
(19,680 |
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$ |
(16,486 |
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Net loss per share - basic and diluted |
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$ |
(0.51 |
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$ |
(0.73 |
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Weighted-average common stock outstanding - basic and diluted |
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38,350,444 |
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22,590,804 |
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Comprehensive loss: |
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Net loss |
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$ |
(19,680 |
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$ |
(16,486 |
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Other comprehensive income (loss): |
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Unrealized (loss) gain on available-for-sale investments, net of tax |
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(164 |
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13 |
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Comprehensive loss |
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$ |
(19,844 |
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$ |
(16,473 |
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Acrivon Therapeutics, Inc. |
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March 31, |
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December 31, |
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2025 |
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2024 |
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Assets |
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Cash and cash equivalents |
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$ |
39,154 |
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$ |
39,818 |
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Investments |
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125,676 |
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$ |
144,751 |
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Other assets |
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11,519 |
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$ |
12,019 |
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Total assets |
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$ |
176,349 |
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$ |
196,588 |
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Liabilities and Stockholders' Equity |
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Liabilities |
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15,959 |
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19,802 |
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Stockholders' Equity |
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160,390 |
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176,786 |
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Total Liabilities and Stockholders' Equity |
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$ |
176,349 |
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$ |
196,588 |
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