AI Earnings Predictions for Acrivon Therapeutics Inc. (ACRV)

EX-99.1

2 acrv-ex99_1.htm

EX-99.1

EX-99.1

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

• Recently presented interim analysis of the ongoing, multi-arm, registrational intent Phase 2b study across both OncoSignature-positive (BM+) and BM- endometrial cancer (EC)

subjects showed a confirmed overall response rate (cORR) of 52% (N = 23) in serous EC subjects versus an ORR of 22% (N = 37) in non-serous EC subjects, with all subjects having received up to two prior lines of therapy (LoT), including chemotherapy and anti-PD-1. This is consistent with the higher BM positivity rate and elevated biomarker levels in subjects with serous versus non-serous EC.

o Arm 1 is ongoing and is stratifying for treatment of EC based on BM+ predicted sensitivity to ACR-368

o Arm 2 was successfully completed, showing that ultra-low dose gemcitabine (ULDG) may contribute to ACR-368 efficacy, while maintaining a favorable tolerability profile, in BM- subjects

o Arm 3 is investigating ACR-368 with ULDG sensitization in serous EC subjects with up to two prior LoT without the need for pre-treatment tumor biopsy or biomarker stratification (“serous all comer”)

o Arm 4 enrollment and dosing was recently initiated, investigating single agent ACR-368 without ULDG, in the same “serous all comer” subject population as Arm 3

• Clinical data from the Phase 2b trial was featured in a late-breaking oral presentation by Professor Panagiotis Konstantinopoulos of the Dana-Farber Cancer Institute at the European Society of Gynecological Oncology (ESGO) Annual Congress, followed by a company-hosted KOL panel, during which renowned experts expressed strong enthusiasm for the data on ACR-368 and reiterated the high unmet need for patients suffering from serous EC

• Two presentations at the American Association for Cancer Research (AACR) Annual Meeting uncovered the underlying molecular mechanisms for potent synergies between ACR-368 and anti-PD-L1 checkpoint inhibitors or Topoisomerase 1 (Topo 1) inhibitors identified by AP3. These findings support potential clinical combination studies with antibody-drug conjugates (ADCs) or immune checkpoint inhibitors (ICIs), including a planned Phase 3 confirmatory study of ACR-368 with ICIs.

ACR-2316: WEE1 / PKMYT1 Inhibitor

• Initial data from the Phase 1 monotherapy dose-escalation trial de

EX-99.1

2 acrv-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

Acrivon Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Recent Business Highlights

Maturing data from the ongoing registrational intent Phase 2b ACR-368 study showed a confirmed overall response rate (cORR) of 52% in serous endometrial cancer (EC)

Late-breaking oral presentation and corporate KOL panel at ESGO 2026 highlighted strong ACR-368 data in serous EC, a high unmet need subtype responsible for ~50% of EC mortality

Initiated Arm 3 (ACR-368 + ultra low-dose gemcitabine) and adding Arm 4 (ACR-368) Phase 2b cohorts in all-comer (biopsy-independent) serous EC subjects

Initial Phase 1 ACR-2316 data in AP3-prioritized solid tumor types showed favorable tolerability and promising clinical activity, notably in heavily pre-treated lung cancer subjects

Cash, cash equivalents and marketable securities of $118.6 million as of December 31, 2025, expected to fund operations into the second quarter of 2027

WATERTOWN, Massachusetts, March 19, 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 fourth quarter and full year ended December 31, 2025 and reviewed recent business highlights.

“It’s an exciting time for the company as we build on strong maturing data and clinical momentum,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and founder of Acrivon. “Our compelling data from ACR-368 in EC was well received at the ESGO Congress, reinforced by powerful commentary from world-renowned key opinion leaders at our live webcast, after the late-breaking oral presentation by Dr. Konstantinopoulos from the Dana- Farber Cancer Institute. Serous EC represents a particularly significant unmet need with a mortality rate resulting in 40-50% of all EC deaths. Through our rapidly maturing data, we are strategically generating multiple opportunities towards potential registration for ACR-368, including our announcement today of a fourth arm to our study to investigate ACR-368 monotherapy in biomarker-unselected serous EC subjects. Elsewhere in our pipeline, ACR-2316 has already shown promising clinical activity in lung cancer, underscoring the potential of its differentiated mechanism of action. Finally, we continue to build our pipeline with our next development candidate, ACR-6840, and new programs, reflecting our sustained AP3-driven innovation and commitment to long-term value creation.”

Recent Highlights

ACR-368: CHK1 / CHK2 Inhibitor

• Clinical data from the ongoing, registrational-intent ACR-368 Phase 2b trial was presented in a late-breaking oral presentation at the European Society of Gynecological Oncology (ESGO) Annual Congress by Dr. Panagiotis (Panos) Konstantinopoulos, M.D., Ph.D., from the Dana-Farber Cancer Institute

o Consistent with higher BM levels in serous versus non-serous EC, an interim analysis across both OncoSignature-positive (BM+) and BM- serous EC subjects showed a cORR of 52% (N = 23) versus 22% (N = 37) in non-serous EC subjects; all subjects in this analysis received up to two prior lines of therapy (LoT), including chemotherapy and anti-PD-1

o Based on this, Arm 3 was initiated in late 2025 to generate prospective data of ACR-368 with ULDG sensitization in all-comer (no pre-treatment biopsy or biomarker stratification) serous EC subjects with ≤2 prior LoT and is actively enrolling and dosing patients in the US, with 4 major EU countries on track to be activated by end of Q1 further accelerating enrollment through the addition of more than 20 EU sites

• Following Dr. Konstantinopoulos’ presentation, the company hosted a KOL panel at ESGO, during which KOL experts expressed strong enthusiasm for ACR-368 and discussed the promising clinical data, emphasizing the high unmet need and potential impact for patients suffering from serous EC.

• Building on promising clinical data and observed biomarker upregulation in serous EC, the company announced today that it plans to initiate a fourth cohort (Arm 4) in the ongoing ACR-368 Phase 2b study in the first half of 2026. This arm will enroll all-comer (BM-unselected) serous EC subjects, similar to Arm 3, but subjects will be treated with ACR-368 monotherapy and otherwise identical inclusion criteria to Arm 3.

• Company also announced today that it has completed the exploratory Arm 2 of the study which treated BM- EC subjects with ≤3 prior LoT using ACR-368 with ULDG sensitization. Objectives of this arm were achieved, supporting that ULDG may contribute to ACR-368 efficacy in BM- subjects with a favorable tolerability profile.

ACR-2316: WEE1 / PKMYT1 Inhibitor

• Initial data from the Phase 1 m

8-K

0001781174false00017811742026-01-082026-01-08

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

Date of Report (Date of earliest event reported): January 08, 2026

Acrivon Therapeutics, Inc. (Exact name of Registrant as Specified in Its Charter)

Delaware

001-41551

82-5125532

(State or Other Jurisdiction of Incorporation)

(Commission File Number)

(IRS Employer Identification No.)

480 Arsenal Way Suite 100

Watertown, Massachusetts

02472

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s Telephone Number, Including Area Code: (617) 207-8979

(Former Name or Former Address, if Changed Since Last Report)

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: ☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) ☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.001 per share

ACRV

The Nasdaq Stock Market LLC

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 January 8, 2026, Acrivon Therapeutics, Inc. (the “Company”) disclosed that, based on preliminary unaudited financial information, it had preliminary unaudited cash, cash equivalents, and investments of approximately $119 million as of December 31, 2025, which, based on current operating plans, is expected to fund operations into the second quarter of 2027. Because the Company’s consolidated financial statements for the year ended December 31, 2025 have not yet been finalized, the preliminary statement of the Company’s cash, cash equivalents and investments as of December 31, 2025 in this Item 2.02 is unaudited and subject to change, and the Company’s actual cash, cash equivalents and investments as of December 31, 2025 may differ materially from this preliminary estimate. Accordingly, you should not place undue reliance on this preliminary estimate. The information in Item 2.02 of this Current Report on Form 8-K is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as expressly set forth by specific reference in such filing. Item 7.01 Regulation FD Disclosure. On January 8, 2026, the Company issued a press release titled “Acrivon Therapeutics Announces Positive ACR-368 Phase 2b Endometrial Cancer Clinical Data with EU Expansion to Accelerate Enrollment, Initial ACR-2316 Clinical Data, and ACR-6840, its Next AP3-Enabled Development Candidate, Targeting CDK11.” A copy of the press release is attached hereto as Exhibit 99.1 and incorporated by reference into this Item 7.01 of this Current Report on Form 8-K.

The information set forth under Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

Item 8.01 Other Events

On January 8, 2026, the Company announced the following clinical data:

ACR-368: Potential First-in-Class CHK1 / CHK2 Inhibitor

•In Arm 1 of the ACR-368 Phase 2b registrational-intent trial (monotherapy BM+ subjects) an updated interim analysis (EDC data extract as of December 4, 2025) showed a ORR of 39%*. In subjects with ≤2 prior lines of therapy (LoT), the ORR was 44%. Based on data that showed higher response rates in subjects with serous EC (also called uterine serous carcino