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  4. [8-K] Acrivon Therapeutics, Inc. Reports Material Event

Acrivon Therapeutics (ACRV) trims Q2 2026 loss while pushing ACR-368 and ACR-2316 forward

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Acrivon Therapeutics reported second-quarter 2026 results and highlighted progress across its precision oncology pipeline built on its Generative Phosphoproteomics AP3 platform. The lead asset ACR-368 continues dosing in all-comer serous endometrial cancer arms of a registrational-intent Phase 2b trial, with a prespecified simultaneous interim analysis and data update from both arms planned for the second half of 2026 and a Phase 3 confirmatory trial targeted for the first half of 2027.

The company’s second program, ACR-2316, a WEE1/PKMYT1 inhibitor, has entered the randomized dose expansion stage of its Phase 1/2 study at 120 mg and 160 mg once-daily doses, with durable single-agent activity observed in several tumor types, including heavily pretreated lung cancers. Acrivon is also advancing an internally discovered CDK11 inhibitor program through IND-enabling studies, with an IND submission planned for the first half of 2027.

For the quarter ended June 30, 2026, Acrivon reported a net loss of $18.0 million, improved from $21.0 million a year earlier, as research and development and general and administrative expenses both declined. Cash, cash equivalents and investments totaled $90.0 million as of June 30, 2026, which the company expects to fund operations into the fourth quarter of 2027.

Positive

  • Net loss narrowed to $18.0 million in Q2 2026 from $21.0 million in Q2 2025, driven by lower research and development and general and administrative expenses.
  • Cash and investments of $90.0 million as of June 30, 2026 are expected to fund operating and capital needs into the fourth quarter of 2027, providing a relatively clear capital runway.
  • Lead program ACR-368 is in a registrational-intent Phase 2b trial with a prespecified interim analysis planned for the second half of 2026, laying groundwork for a Phase 3 confirmatory study.
  • ACR-2316 has advanced into randomized dose expansion with favorable safety and durable antitumor activity across multiple tumor types, including heavily pretreated lung cancers.

Negative

  • None.

Filing Explained

The August 12 release was furnished, not filed, and June 30 liquidity was reported as $90.0 million.

Acrivon furnished its second-quarter results under Form 8-K Item 2.02, but the release is not treated as “filed” for Section 18 liability purposes; the filing therefore reports the results without changing the company’s disclosed capital structure.

At June 30, the company reported $90.0 million of cash, cash equivalents and investments and stated that the combined amount was expected to fund operations and capital expenditures into the fourth quarter of 2027.

The cash-and-equivalents balance alone equaled 250.8 days of the last reported quarterly operating cash use, a backward-looking liquidity comparison rather than a revised funding commitment.

Sources and calculations
  • Cash and equivalents vs quarterly operating cash outflow, in days of cash use $41,417,000 / ($14,862,000 / 90) = [object Object]
Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Net loss Q2 2026 $18.0 million Quarter ended June 30, 2026
Net loss Q2 2025 $21.0 million Quarter ended June 30, 2025
R&D expense Q2 2026 $13.8 million Quarter ended June 30, 2026
G&A expense Q2 2026 $4.8 million Quarter ended June 30, 2026
Cash, cash equivalents and investments $90.0 million As of June 30, 2026; expected to fund into Q4 2027
Total assets June 30, 2026 $99.1 million Condensed consolidated balance sheet
Total operating expenses Q2 2026 $18.7 million Quarter ended June 30, 2026
Weighted-average shares Q2 2026 41,841,887 Basic and diluted shares outstanding
Generative Phosphoproteomics AP3 platform technical
"utilizing its proprietary Generative Phosphoproteomics AP3 platform deployed for rational drug design"
registrational-intent Phase 2b regulatory
"serous endometrial cancer arms of the Phase 2b study in the registrational-intent Phase 2b study"
WEE1/PKMYT1 inhibitor medical
"ACR-2316, a novel, potent, selective WEE1/PKMYT1 inhibitor designed for superior single-agent activity"
A Wee1/PKMYT1 inhibitor is a drug that blocks two enzymes that act as cellular “brakes” controlling when a cell divides. By releasing those brakes, the medicine forces damaged or rapidly dividing cancer cells to attempt division before they are ready, which can lead to cell death; this makes the approach useful alone or paired with chemotherapy or radiation. For investors, these drugs are high-impact but often experimental, carrying potential for strong therapeutic benefit alongside safety and development risks.
Fast Track designation regulatory
"The company has received Fast Track designation from the Food and Drug Administration"
Fast track designation is a status the U.S. Food and Drug Administration grants to drugs intended to treat serious conditions and address an unmet medical need. It gives the developer more frequent communication with the FDA and can allow parts of the application to be reviewed on a rolling basis, and it may pave the way to priority review or accelerated approval. It can shorten development timelines, though it does not guarantee approval.
Breakthrough Device designation regulatory
"The FDA has granted a Breakthrough Device designation for the ACR-368 OncoSignature assay"
A breakthrough device designation is a regulatory program that gives promising medical devices for serious or life‑threatening conditions priority support and faster review from a health authority (e.g., the U.S. FDA). Think of it as a “fast lane” or VIP pass through development and review: it can shorten time to market, lower regulatory uncertainty, and boost a company’s commercial prospects — but it is not an approval by itself.
IND-enabling studies regulatory
"back-up lead compounds showing complete regression in preclinical in vivo AML models being advanced in Investigational New Drug (IND)-enabling studies"
Ind-enabling studies are early research efforts that test whether a new drug or treatment is safe and effective enough to move forward in development. They are like preliminary tests to ensure a product works as intended before investing more resources into large-scale trials. For investors, these studies are important because successful results can signal potential progress toward bringing a new product to market, impacting its future value.
Net loss Q2 2026 $18.0 million Improved from $21.0 million in Q2 2025
Net loss six months 2026 $37.0 million Improved from $40.7 million for the six months ended June 30, 2025
R&D expense Q2 2026 $13.8 million Down from $16.2 million in Q2 2025
G&A expense Q2 2026 $4.8 million Down from $6.5 million in Q2 2025
Cash, cash equivalents and investments $90.0 million Company expects this to fund operations into Q4 2027

AI-generated analysis. How Rhea-AI works. Not financial advice.

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FAQ

What were Acrivon Therapeutics (ACRV) second-quarter 2026 financial results?
Acrivon reported a net loss of $18.0 million for Q2 2026, compared to a net loss of $21.0 million in Q2 2025, reflecting lower research and development and general and administrative expenses during the period.

How much cash runway does Acrivon Therapeutics (ACRV) report as of June 30, 2026?
As of June 30, 2026, Acrivon held $90.0 million in cash, cash equivalents and investments, which it expects to fund operating expenses and capital expenditure requirements into the fourth quarter of 2027.

What is the status of ACR-368 in Acrivon Therapeutics (ACRV)’s pipeline?
ACR-368 is in a registrational-intent Phase 2b trial in all-comer serous endometrial cancer, with a prespecified interim analysis planned for the second half of 2026 and a Phase 3 confirmatory trial targeted for the first half of 2027.

How is ACR-2316 progressing at Acrivon Therapeutics (ACRV)?
ACR-2316, a WEE1/PKMYT1 inhibitor, has advanced into the randomized dose expansion stage of its Phase 1/2 trial, evaluating 120 mg and 160 mg once-daily dosing and showing durable single-agent activity in several tumor types.

What upcoming milestones did Acrivon Therapeutics (ACRV) highlight?
Planned milestones include a prespecified interim analysis of ACR-368 Phase 2b in the second half of 2026, potential Phase 3 initiation for ACR-368 in the first half of 2027, and an IND filing for a CDK11 inhibitor in the first half of 2027.

How did operating expenses change for Acrivon Therapeutics (ACRV) in Q2 2026?
Total operating expenses were $18.7 million in Q2 2026 versus $22.6 million in Q2 2025, reflecting lower research and development expenses and reduced general and administrative costs, including decreased employee-related and stock-based compensation.
false000178117400017811742026-08-122026-08-12

 

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): August 12, 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 August 12, 2026, Acrivon Therapeutics, Inc., or the Company, issued a press release announcing its financial results for the quarter ended June 30, 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.

 

Exhibit

Number

Description

99.1

Press Release, dated August 12, 2026

104

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.

 

 

 

Acrivon Therapeutics, Inc.

 

 

 

 

Date:

August 12, 2026

By:

/s/ Peter Blume-Jensen, M.D., Ph.D.

 

 

 

Name: Peter Blume-Jensen, M.D., Ph.D.
Title: President and Chief Executive Officer
 

 

Exhibit 99.1

img28311487_0.jpg

Acrivon Reports Second Quarter 2026 Financial Results and Highlights Upcoming 2026 Clinical Data Catalysts
 

ACR-368 Phase 2b prespecified interim analysis and data from all-comer serous endometrial cancer (EC) treatment arms on track for second half of 2026

ACR-2316 Phase 1/2 trial in AP3-prioritized tumor types advancing in randomized dose expansion phase supported by a promising, favorable safety profile and durable single-agent clinical activity in several tumor types

Cash, cash equivalents, and marketable securities of $90.0 million as of June 30, 2026 expected to fund operations into fourth quarter of 2027


WATERTOWN, Massachusetts, August 12, 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 second quarter ended June 30, 2026 and reviewed recent business highlights.

“As we look ahead to the second half of 2026, we remain excited about the continued rapid clinical advancement of our precision medicine pipeline,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president and co-founder of Acrivon. “For ACR-368, this includes the prespecified interim analysis of the registrational-intent, all-comer, serous endometrial cancer arms of the Phase 2b study. For ACR-2316, we have recently entered the randomized dose expansion stage in our Phase 1/2 study, supported by a favorable, differentiated safety profile and durable single-agent activity, including in heavily pretreated lung cancer subjects. Several subjects from the dose escalation phase now remain on treatment for more than one year.”

Recent Highlights

ACR-368

•
Dosing continues in both all-comer serous EC arms (Arm 4 single agent and Arm 3 with ultra-low dose gemcitabine sensitization) in the registrational-intent Phase 2b study, across both US and European clinical sites.
•
Two presentations at the American Association for Cancer Research (AACR) Annual Meeting highlighted data showing the underlying molecular mechanisms for potent synergies between ACR-368 and immune checkpoint inhibitors (ICIs) or Topoisomerase 1 (Topo 1) inhibitors identified by AP3. These findings support the potential for clinical combination studies with antibody-drug conjugates (ADCs) or ICIs.

 

 

ACR-2316

•
ACR-2316 advanced into the randomized dose expansion stage of the Phase 1/2 study, supported by observed favorable safety profile and durable antitumor activity. The expansion phase is evaluating 120 mg and 160 mg doses, administered orally, once-daily (QD) utilizing a 3d on / 4d off weekly administration schedule.
•
Dose expansion phase will assess safety and activity in subjects with AP3-identified, molecularly-defined lung, endometrial, cervical, and esophago-gastric junction cancers.
•
Data presented at the AACR Annual Meeting uncovered the molecular underpinnings driving strong synergy and resulting in complete tumor regression with durable immune memory upon treatment with ACR-2316 and ICI, providing a mechanistic rationale for potential combinations with ICIs.
•
Oral podium and poster presentations at the AACR Drug Discovery and Development conference demonstrated how AP3 guided the design of ACR-2316 for optimal intracellular pathway effects, including sustained activation of CDK1, CDK2, and importantly also of PLK1, and quenching of the dominant resistance mechanisms to drive potent pro-apoptotic tumor cell death.

 

CDK11 Inhibitor Program

•
Internally-discovered development candidate from company’s AP3-driven cell cycle program and several equally promising back-up lead compounds showing complete regression in preclinical in vivo AML models being advanced in Investigational New Drug (IND)-enabling studies.

 

Anticipated Upcoming Milestones

ACR-368 Ongoing Registrational Intent Phase 2b Study

•
A prespecified simultaneous interim analysis and data update from both all-comer (biopsy-independent) serous EC arms of the ACR-368 Phase 2b study in second half of 2026
•
Initiate Phase 3 confirmatory trial for ACR-368 in first half of 2027
•
Based on interim data read-out, complete enrollment of the registrational intent all-comer (biopsy-independent) serous EC Arm 3 or Arm 4 by fourth quarter of 2026

 

Broader Pipeline

•
Submit IND filing to the FDA for CDK11 inhibitor development candidate in first half of 2027
•
Initiate additional AP3-driven drug discovery programs in 2026

 

Second Quarter 2026 Financial Results

Net loss for the quarter ended June 30, 2026 was $18.0 million compared to a net loss of $21.0 million for the same period in 2025.

Research and development expenses were $13.8 million for the quarter ended June 30, 2026 compared to $16.2 million for the same period in 2025. The difference is primarily driven by two

 

 

milestones achieved for ACR-368 in 2025 which did not recur in 2026, as well as timing of the progression of other programs.

General and administrative expenses were $4.8 million for the quarter ended June 30, 2026, compared to $6.5 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 June 30, 2026, the company had cash, cash equivalents and investments of $90.0 million, which is expected to fund operating expenses and capital expenditure requirements into the fourth 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 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 EC. 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 EC. 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, a novel, potent, selective WEE1/PKMYT1 inhibitor designed for superior single-agent activity. The Phase 1/2 study of ACR-2316 is advancing in a randomized dose expansion phase. Initial data has shown a highly differentiated, favorable safety profile primarily limited to only transient, mechanism-based hematological adverse events, predominantly only neutropenia. Clinical activity has been observed across multiple tumor types, including SCLC, squamous NSCLC and lung adenocarcinoma, tumor types not shown sensitive to current single-agent WEE1 or PKMYT1 inhibitors. Durable clinical activity has been observed, with certain lung cancer subjects remaining on treatment more than one year.

In addition, the company is in early IND-enabling studies with several potential first-in-class 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.
alevy@acrivon.com

Alexandra Santos
asantos@wheelhouselsa.com

 

 

 

Acrivon Therapeutics, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(unaudited, in thousands, except share and per share data)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2026

 

 

2025

 

 

2026

 

 

2025

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

13,844

 

 

$

16,182

 

 

$

29,010

 

 

$

31,596

 

General and administrative

 

 

4,824

 

 

 

6,467

 

 

 

9,560

 

 

 

12,715

 

Total operating expenses

 

 

18,668

 

 

 

22,649

 

 

 

38,570

 

 

 

44,311

 

Loss from operations

 

 

(18,668

)

 

 

(22,649

)

 

 

(38,570

)

 

 

(44,311

)

Other income (expense), net:

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

860

 

 

 

1,730

 

 

 

1,849

 

 

 

3,726

 

Other expense, net

 

 

(156

)

 

 

(87

)

 

 

(285

)

 

 

(101

)

Total other income, net

 

 

704

 

 

 

1,643

 

 

 

1,564

 

 

 

3,625

 

Net loss

 

$

(17,964

)

 

$

(21,006

)

 

$

(37,006

)

 

$

(40,686

)

Net loss per share - basic and diluted

 

$

(0.43

)

 

$

(0.55

)

 

$

(0.92

)

 

$

(1.06

)

Weighted-average common stock outstanding - basic and diluted

 

 

41,841,887

 

 

 

38,461,619

 

 

 

40,291,956

 

 

 

38,406,339

 

Comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(17,964

)

 

$

(21,006

)

 

$

(37,006

)

 

$

(40,686

)

Other comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized loss on available-for-sale investments, net of tax

 

 

(37

)

 

 

(177

)

 

 

(144

)

 

 

(341

)

Comprehensive loss

 

$

(18,001

)

 

$

(21,183

)

 

$

(37,150

)

 

$

(41,027

)

 

 

Acrivon Therapeutics, Inc.
Condensed Consolidated Balance Sheets
(unaudited, in thousands)

 

 

 

 

 

 

 

 

 

 

June 30,

 

 

December 31,

 

 

 

2026

 

 

2025

 

Assets

 

 

 

 

 

 

Cash and cash equivalents

 

$

41,417

 

 

$

41,499

 

Investments

 

 

48,542

 

 

 

77,083

 

Other assets

 

 

9,133

 

 

 

11,135

 

Total assets

 

$

99,092

 

 

$

129,717

 

Liabilities and Stockholders' Equity

 

 

 

 

 

 

Liabilities

 

$

12,427

 

 

$

17,201

 

Stockholders' Equity

 

 

86,665

 

 

 

112,516

 

Total Liabilities and Stockholders' Equity

 

$

99,092

 

 

$

129,717

 

 

 

Source: View Original Filing on SEC EDGAR

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