ACRV Acrivon Therapeutics Inc

 

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): November 13, 2024

 

 

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:

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. ☐

 

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Item 2.02 Results of Operations and Financial Condition.

On November 13, 2024, Acrivon Therapeutics, Inc., or the Company, issued a press release announcing its financial results for the quarter ended September 30, 2024 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 November 13, 2024
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

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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:	November 13, 2024	By:	/s/ Peter Blume-Jensen
			Name: Peter Blume-Jensen, M.D., Ph.D. Title: President and Chief Executive Office

 

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Acrivon Therapeutics Reports Third Quarter 2024 Financial Results and Business Highlights

 

 

 

 

WATERTOWN, Massachusetts, November 13, 2024 – Acrivon Therapeutics, Inc. (“Acrivon” or “Acrivon Therapeutics”) (Nasdaq: ACRV), a clinical stage precision medicine company utilizing its Acrivon Predictive Precision Proteomics (AP3) platform for the discovery, design, and development of drug candidates through a mechanistic match to patients whose disease is predicted sensitive to the specific treatment, today reported financial results for the third quarter ended September 30, 2024 and reviewed recent business highlights.

“Our team continues to deliver impressive progress advancing a pipeline of differentiated clinical stage therapies,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and founder of Acrivon. “During the third quarter, we shared promising data from our Phase 2b study of ACR-368, demonstrating a confirmed 62.5% ORR in patients with high-grade endometrial cancer - a tumor type identified by AP3 as sensitive to ACR-368. Equally important, we further validated our ACR-368 OncoSignature prospective patient selection with a p-value = 0.009. We continue to believe endometrial cancer provides the first potential approval opportunity for ACR-368. Our recently conducted, blinded KOL market research confirmed the significant unmet need for the approximately 30,000 annual new cases of high-grade endometrial cancer in the U.S., and we believe that ACR-368 could offer an important treatment option for this devastating disease. In addition, we advanced ACR-2316 into the clinic ahead of schedule in just 15 months from initial lead to Phase 1 trial initiation, uniquely enabled by AP3, with the planned first dose-escalation cohort now fully enrolled. These significant milestones underscore the power of our proprietary generative AI and machine learning-driven AP3 Interactome applied to our growing in-house data sets for streamlined drug discovery and clinical development.”

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Recent Highlights

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Anticipated Upcoming Milestones

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Third Quarter 2024 Financial Results

Net loss for the quarter ended September 30, 2024 was $22.4 million compared to a net loss of $14.5 million for the same period in 2023.

Research and development expenses were $18.9 million for the quarter ended September 30, 2024 compared to $10.3 million for the same period in 2023. The difference was primarily due to the continued development of ACR-368 -- which included the progression of the ongoing clinical trial and the achievement of milestones for the companion diagnostic, the initiation of the ACR-2316 clinical trial in the third quarter of 2024, and increased personnel costs to support these development activities.

General and administrative expenses were $6.3 million for the quarter ended September 30, 2024 compared to $5.9 million for the same period in 2023. The difference was primarily due to increased personnel costs, inclusive of non-cash stock compensation expense.

As of September 30, 2024, the company had cash, cash equivalents and marketable securities of $202.8 million, which is expected to fund our operating expenses and capital expenditure requirements into the second half of 2026.

 

About Acrivon Therapeutics
Acrivon is a clinical stage biopharmaceutical company developing precision oncology medicines that it matches to patients whose tumors are predicted to be sensitive to each specific medicine by utilizing Acrivon’s proprietary proteomics-based patient responder identification platform, Acrivon Predictive Precision Proteomics, or AP3. The AP3 platform is engineered to measure compound-specific effects on the entire tumor cell protein signaling network and drug-induced resistance mechanisms in an unbiased manner. These distinctive capabilities enable AP3’s direct application for drug design optimization for monotherapy activity, the identification of rational drug combinations, and the creation of drug-specific proprietary OncoSignature companion diagnostics that are used to identify the patients most likely to benefit from Acrivon’s drug candidates. Acrivon is currently advancing its lead candidate, ACR-368 (also known as prexasertib), a selective small molecule inhibitor targeting CHK1 and CHK2 in a registrational-intent Phase 2b trial across multiple tumor types. The company has received Fast Track designation from the Food and Drug Administration, or FDA, for the investigation of ACR-368 as monotherapy based on OncoSignature-predicted sensitivity in patients with platinum-resistant ovarian or endometrial cancer. Acrivon’s ACR-368 OncoSignature test, which has not yet obtained regulatory approval, has been extensively evaluated in preclinical studies, including in

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two separate, blinded, prospectively-designed studies on pretreatment tumor biopsies collected from past third-party Phase 2 trials in patients with ovarian cancer treated with ACR-368. The FDA has granted Breakthrough Device designation for the ACR-368 OncoSignature assay for the identification of ovarian cancer patients who may benefit from ACR-368 treatment. The company reported positive clinical data for ovarian and endometrial cancers in April 2024, and in September 2024 it reported additional positive clinical data for endometrial cancer, including a confirmed overall response rate of 62.5% (95% CI, 30.4 - 86.5) and further validation of its prospective OncoSignature selection of patients predicted sensitive to ACR-368 by showing segregation of responders in OncoSignature-positive versus OncoSignature-negative patients (p = 0.009). The median duration of treatment was not yet reached, but the duration on study was 6 months at the time of the data cut.

In addition to ACR-368, Acrivon is also leveraging its proprietary AP3 precision medicine 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 demonstrated in preclinical studies against benchmark inhibitors. In addition, the company has a preclinical cell cycle program with an undisclosed target.

Acrivon has developed AP3 Interactome, a proprietary, computational analytics platform driven by machine learning for integrated comprehensive analyses across all large, in-house AP3 phosphoproteomic drug profiling data sets to advance its in-house research programs.

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.
alevy@acrivon.com

Alexandra Santos
asantos@wheelhouselsa.com

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Acrivon Therapeutics, Inc. Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited, in thousands, except share and per share data)
		Three Months Ended September 30,								Nine Months Ended September 30,
		2024				2023				2024				2023
Operating expenses:
Research and development		$	18,864			$	10,267			$	45,362			$	30,546
General and administrative			6,276				5,870				18,883				15,504
Total operating expenses			25,140				16,137				64,245				46,050
Loss from operations			(25,140	)			(16,137	)			(64,245	)			(46,050	)
Other income (expense), net:
Interest income			2,698				1,768				6,838				5,345
Other income (expense), net			1				(97	)			(318	)			(431	)
Total other income, net			2,699				1,671				6,520				4,914
Net loss		$	(22,441	)		$	(14,466	)		$	(57,725	)		$	(41,136	)
Net loss per share - basic and diluted		$	(0.59	)		$	(0.66	)		$	(1.79	)		$	(1.87	)
Weighted-average common stock outstanding - basic and diluted			38,105,131				22,081,162				32,297,457				21,991,509
Comprehensive loss:
Net loss		$	(22,441	)		$	(14,466	)		$	(57,725	)		$	(41,136	)
Other comprehensive income (loss):
Unrealized gain (loss) on available-for-sale investments, net of tax			801				125				865				(207	)
Comprehensive loss		$	(21,640	)		$	(14,341	)		$	(56,860	)		$	(41,343	)

 

Acrivon Therapeutics, Inc. Condensed Consolidated Balance Sheets (unaudited, in thousands)
		September 30, 2024				December 31, 2023
Assets
Cash and cash equivalents		$	43,415			$	36,015
Investments			159,428				91,443
Other assets			11,841				10,807
Total assets		$	214,684			$	138,265
Liabilities and Stockholders' Equity
Liabilities			17,792				17,070
Stockholders' Equity			196,892				121,195
Total Liabilities and Stockholders' Equity		$	214,684			$	138,265

 

 

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v3.24.3

Document And Entity Information	Nov. 13, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Nov. 13, 2024
Entity Registrant Name	Acrivon Therapeutics, Inc.
Entity Central Index Key	0001781174
Entity Emerging Growth Company	true
Entity File Number	001-41551
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	82-5125532
Entity Address, Address Line One	480 Arsenal Way
Entity Address, Address Line Two	Suite 100
Entity Address, City or Town	Watertown
Entity Address, State or Province	MA
Entity Address, Postal Zip Code	02472
City Area Code	(617)
Local Phone Number	207-8979
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Entity Ex Transition Period	false
Title of 12(b) Security	Common Stock, par value $0.001 per share
Trading Symbol	ACRV
Security Exchange Name	NASDAQ

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