UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
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 March 28, 2024, Acrivon Therapeutics, Inc. issued a press release announcing its financial results for the fourth quarter and full year ended December 31, 2023. 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: |
March 28, 2024 |
By: |
/s/ Peter Blume-Jensen |
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Peter Blume-Jensen, M.D., Ph.D. |
Exhibit 99.1
Acrivon Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Business Highlights
WATERTOWN, Massachusetts, March 28, 2024 – Acrivon Therapeutics, Inc. (“Acrivon” or “Acrivon Therapeutics”) (Nasdaq: ACRV), 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 its proprietary proteomics-based patient responder identification platform, Acrivon Predictive Precision Proteomics (AP3), today reported financial results for the fourth quarter and full year ended December 31, 2023 and provided business highlights.
“On the heels of a productive 2023, we are off to a tremendous start in 2024, which is an important and data-driven year for Acrivon,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and founder of Acrivon. “Following the encouraging clinical observations conveyed in November for our ongoing Phase 2 trial with ACR-368, we continue to enroll and dose patients in the study and now have 66 clinical trial sites activated. We remain on track to present more mature clinical data during the first half of 2024. We are also pleased to report that the Phase 1b arm of the study evaluating ACR-368 in combination with low dose gemcitabine in the same three indications for OncoSignature-negative patients is complete, and we are now entering the exploratory Phase 2 part of the trial. Additionally, our novel WEE1/PKMYT1 inhibitor ACR-2316 continues to demonstrate robust and superior single-agent preclinical activity and tolerability as demonstrated in head-to-head benchmark studies. At the upcoming annual AACR meeting we will present data demonstrating the central role of our AP3 platform for the rapid, rational drug discovery of ACR-2316, and the clinical development and patient selection approach for ACR-368.”
Recent Highlights
Pipeline Programs
Corporate
Anticipated Upcoming Milestones
Fourth Quarter and Full Year 2023 Financial Results
Net loss for the quarter and full year ended December 31, 2023 was $19.3 million and $60.4 million, respectively. This compares to a net loss of $8.9 million and $31.2 million, respectively, for the same periods in 2022.
Research and development expenses were $15.5 million for the quarter ended December 31, 2023, and $46.0 million for the full year 2023, compared to $5.9 million and $23.9 million, respectively, for the same periods in 2022. The difference was primarily due to the continued development of ACR-368, inclusive of progression of the ongoing clinical trial and achieved Akoya milestones, as well as increased personnel costs to support these development activities and costs associated with our preclinical programs, including ACR-2316.
General and administrative expenses were $5.6 million for the quarter ended December 31, 2023, and $21.1 million for the full year 2023, compared to $4.1 million and $8.7 million, respectively, for the same periods in 2022. The difference was primarily due to the increased cost of operating as a public company, inclusive of increased personnel costs and non-cash stock compensation expense.
As of December 31, 2023, the company had cash, cash equivalents and marketable securities of $127.5 million, which is expected to fund operations into the fourth quarter of 2025.
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, a selective small molecule inhibitor targeting CHK1 and CHK2 in a potentially registrational Phase 2 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 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. In addition to ACR-368, Acrivon is also leveraging its proprietary AP3 precision medicine platform for developing its co-crystallography-driven, internally-discovered preclinical stage pipeline programs. These include ACR-2316, a potent, selective WEE1/PKMYT1 inhibitor designed for superior single-agent activity as demonstrated in preclinical studies again benchmark inhibitors, and a 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, 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
Acrivon Therapeutics, Inc. |
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Three Months Ended December 31, |
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Year Ended December 31, |
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2023 |
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2022 |
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2023 |
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2022 |
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Operating expenses: |
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Research and development |
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$ |
15,478 |
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$ |
5,862 |
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$ |
46,024 |
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$ |
23,949 |
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General and administrative |
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5,575 |
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4,083 |
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21,079 |
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8,708 |
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Total operating expenses |
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21,053 |
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9,945 |
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67,103 |
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32,657 |
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Loss from operations |
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(21,053 |
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(9,945 |
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(67,103 |
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(32,657 |
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Other income, net |
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1,801 |
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1,016 |
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6,715 |
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1,490 |
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Net loss |
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$ |
(19,252 |
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$ |
(8,929 |
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$ |
(60,388 |
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$ |
(31,167 |
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Net loss per share - basic and diluted |
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$ |
(0.86 |
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$ |
(0.80 |
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$ |
(2.74 |
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$ |
(7.56 |
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Weighted-average common stock outstanding - basic and diluted |
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22,335,407 |
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11,093,563 |
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22,078,190 |
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4,121,912 |
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Comprehensive loss: |
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Net loss |
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$ |
(19,252 |
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$ |
(8,929 |
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$ |
(60,388 |
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$ |
(31,167 |
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Other comprehensive loss: |
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Unrealized gain (loss) on available-for-sale investments, net of tax |
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219 |
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38 |
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12 |
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(95 |
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Comprehensive loss |
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$ |
(19,033 |
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$ |
(8,891 |
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$ |
(60,376 |
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$ |
(31,262 |
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Acrivon Therapeutics, Inc. |
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December 31, |
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2023 |
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2022 |
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Assets |
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Cash and cash equivalents |
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$ |
36,015 |
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$ |
29,519 |
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Short-term investments |
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91,443 |
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98,232 |
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Long-term investments |
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- |
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41,881 |
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Other assets |
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10,807 |
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11,594 |
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Total assets |
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$ |
138,265 |
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$ |
181,226 |
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Liabilities and Stockholders' Equity |
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Liabilities |
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17,070 |
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10,751 |
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Stockholders' Equity |
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121,195 |
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170,475 |
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Total Liabilities and Stockholders' Equity |
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$ |
138,265 |
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$ |
181,226 |
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