Core Insights - Acrivon Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on developing precision oncology medicines using its proprietary platform, Acrivon Predictive Precision Proteomics (AP3) [1][3] - The company has granted an equity award in the form of stock options to an employee as part of its 2023 Inducement Plan, with options to purchase 99,300 shares of common stock [2] Company Overview - Acrivon utilizes the AP3 platform to identify patients whose tumors are predicted to be sensitive to specific medicines, optimizing drug design and identifying rational drug combinations [3] - The lead candidate, ACR-368, is a selective small molecule inhibitor targeting CHK1 and CHK2, currently in a potentially registrational Phase 2 trial for multiple tumor types [3] - ACR-368 has received Fast Track designation from the FDA for use as monotherapy in patients with platinum-resistant ovarian or endometrial cancer [3] - The ACR-368 OncoSignature test, which is still awaiting regulatory approval, has been evaluated in preclinical studies and has received Breakthrough Device designation from the FDA [3] - Acrivon is also developing additional preclinical stage programs, including ACR-2316, a selective dual WEE1/PKMYT1 inhibitor [3]

Company Overview - Acrivon Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on developing precision oncology medicines using its proprietary platform, Acrivon Predictive Precision Proteomics (AP3) [2] - The AP3 platform identifies patients whose tumors are predicted to be sensitive to specific medicines by measuring compound-specific effects on tumor cell protein signaling networks and drug-induced resistance mechanisms [2] Key Developments - Acrivon is advancing its lead candidate, ACR-368, a selective small molecule inhibitor targeting CHK1 and CHK2, currently in a potentially registrational Phase 2 trial across multiple tumor types [2] - The FDA has granted Fast Track designation for ACR-368 as monotherapy for patients with platinum-resistant ovarian or endometrial cancer based on OncoSignature-predicted sensitivity [2] - ACR-368's OncoSignature assay has received Breakthrough Device designation from the FDA for identifying ovarian cancer patients who may benefit from ACR-368 treatment [2] Upcoming Events - The company's president and CEO, Peter Blume-Jensen, will present an overview at the 42nd Annual J.P. Morgan Healthcare Conference on January 11, 2024 [1]

Core Insights - Acrivon Therapeutics has appointed Dr. Jean-Marie Cuillerot as Chief Medical Officer, bringing over 20 years of oncology drug development experience to the company [1][2] - The company is focused on developing precision oncology medicines using its proprietary platform, Acrivon Predictive Precision Proteomics (AP3), which matches patients to therapies based on tumor sensitivity [1][6] Company Developments - Dr. Cuillerot has a strong track record in advancing oncology drugs from early development to regulatory approval, having previously held leadership roles at Dragonfly Therapeutics and Agenus [2][3] - Acrivon has also announced other personnel updates, including Dr. Erick Gamelin transitioning to Chief Development Officer and the appointments of Dr. Karl Hsu and Ms. Rajshree Kandadai to senior roles [4][5] Product Pipeline - Acrivon's lead candidate, ACR-368, is a selective small molecule inhibitor targeting CHK1 and CHK2, currently in a potentially registrational Phase 2 trial for multiple tumor types [6] - The company has received Fast Track designation from the FDA for ACR-368 as a monotherapy for patients with platinum-resistant ovarian or endometrial cancer [6] - Acrivon is also developing ACR-2316, a selective dual WEE1/PKMYT1 inhibitor, as part of its preclinical pipeline [6]

Financial Performance - Acrivon incurred net losses of $41.1 million and $22.2 million for the nine months ended September 30, 2023, and 2022, respectively, with an accumulated deficit of $97.2 million as of September 30, 2023[107]. - The company has not generated any revenue from drug sales and does not expect to do so in the foreseeable future[113]. - Net loss for the three months ended September 30, 2023, was $14.5 million, compared to a net loss of $9.2 million for the same period in 2022, an increase of $5.3 million[125]. - For the nine months ended September 30, 2023, research and development expenses totaled $30.5 million, up from $18.1 million in the same period of 2022, a $12.5 million increase[135]. - General and administrative expenses for the nine months ended September 30, 2023, were $15.5 million, compared to $4.6 million for the same period in 2022, an increase of $10.9 million[137]. - Total operating expenses for the three months ended September 30, 2023, were $16.1 million, compared to $9.6 million for the same period in 2022, reflecting a $6.6 million increase[125]. - The company anticipates incurring significant expenses and operating losses as it advances drug candidates through clinical development and seeks regulatory approval[149]. Cash and Investments - As of September 30, 2023, Acrivon had cash, cash equivalents, and investments totaling $142.1 million, expected to fund operations into the second half of 2025[110]. - The company expects to fund its operating expenses and capital expenditure requirements into the second half of 2025 with existing cash and investments[140]. - Net cash used in operating activities was $30.3 million for the nine months ended September 30, 2023, compared to $20.8 million for the same period in 2022, reflecting an increase of $9.5 million primarily due to a net loss increase of $18.9 million[144]. - Net cash provided by investing activities was $30.2 million for the nine months ended September 30, 2023, resulting from $70.3 million in proceeds from maturities of short-term investments, offset by $39.9 million in purchases of investments[145]. Research and Development - The company has incurred significant research and development expenses, primarily related to ACR-368 and the ACR-368 OncoSignature[114]. - Research and development expenses increased to $10.3 million for the three months ended September 30, 2023, compared to $7.9 million for the same period in 2022, representing a $2.3 million increase[125]. - The increase in research and development expenses was primarily due to a $1.9 million rise in personnel-related costs, including $0.5 million of stock-based compensation[128]. - The company plans to substantially increase research and development expenses as it continues the development of ACR-368 and ACR-2316[116]. Regulatory and Clinical Developments - The ongoing Phase 2 trial for ACR-368 is based on OncoSignature-predicted sensitivity in patients with platinum-resistant ovarian cancer and other tumor types[100]. - Acrivon has received two Fast Track designations from the FDA for ACR-368 for patients with OncoSignature-positive platinum-resistant ovarian cancer and endometrial cancer[102]. Agreements and Obligations - Acrivon has entered into a companion diagnostic agreement with Akoya Biosciences, with a total potential payment of up to $10.3 million upon achieving specified milestones[112]. - The company is obligated to pay up to $168.0 million in milestone payments under its license agreement with Lilly, with $5.0 million due prior to NDA[156]. - Under the companion diagnostic agreement with Akoya, the company is obligated to pay up to $10.3 million upon achieving specified development milestones, with $3.8 million already paid[157]. - Future minimum commitments under operating leases are $5.3 million as of September 30, 2023, with $1.1 million due within the next 12 months[155]. Funding and Growth Strategy - Acrivon expects to require substantial additional funding to support ongoing operations and growth strategy, with potential impacts from global economic conditions[109]. - The company expects to finance cash needs through equity offerings, debt financings, and collaborations, which may dilute existing stockholder interests[152]. Internal Controls and Company Classification - The company identified material weaknesses in internal control over financial reporting, which could affect the accuracy and timeliness of financial reporting[161]. - The company remains classified as an "emerging growth company" and a "smaller reporting company," allowing it to take advantage of certain exemptions from disclosure requirements[163][165].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________________ to __________________ Commission File Number: 001-41551 Acrivon Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) Dela ...

Part I [Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The unaudited financial statements for Q1 2023 report a **net loss of $12.8 million** and a decrease in total assets to **$170.2 million** [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to **$170.2 million** by March 31, 2023, primarily due to reduced cash and investments, with accumulated deficit reaching **$68.8 million** Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $27,489 | $29,519 | | Short-term & Long-term investments | $132,000 | $140,113 | | Total current assets | $123,963 | $132,095 | | Total assets | $170,197 | $181,226 | | **Liabilities & Equity** | | | | Total liabilities | $9,728 | $10,751 | | Accumulated deficit | $(68,788) | $(56,032) | | Total stockholders' equity | $160,469 | $170,475 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported a **net loss of $12.8 million** for Q1 2023, an increase from **$7.2 million** in Q1 2022, driven by higher operating expenses Statement of Operations Summary (in thousands) | Item | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | Research and development | $9,758 | $6,068 | | General and administrative | $4,635 | $1,144 | | **Total operating expenses** | **$14,393** | **$7,212** | | Loss from operations | $(14,393) | $(7,212) | | **Net loss** | **$(12,756)** | **$(7,220)** | | Net loss per share—basic and diluted | $(0.58) | $(4.08) | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to **$11.4 million** in Q1 2023, while investing activities provided **$9.3 million** from investment maturities Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(11,357) | $(8,418) | | Net cash provided by (used in) investing activities | $9,327 | $(415) | | Net cash provided by financing activities | $— | $— | | **Net decrease in cash, cash equivalents, and restricted cash** | **$(2,030)** | **$(8,833)** | [Notes to the Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's clinical-stage oncology business, its **$159.5 million** liquidity position, and key accounting policies, including commitments and lead program ACR-368 - The company is a clinical-stage biopharmaceutical firm developing oncology medicines using its proteomics-based platform, with ACR-368 as its lead program[27](index=27&type=chunk) - The company has incurred recurring losses since inception, reporting a **net loss of $12.8 million** for Q1 2023 and an **accumulated deficit of $68.8 million**[30](index=30&type=chunk) - Existing cash, cash equivalents, and investments totaling **$159.5 million** as of March 31, 2023, are projected to fund operations for at least 12 months[31](index=31&type=chunk) - A license agreement with Eli Lilly may require up to **$168.0 million** in development and commercial milestone payments, plus tiered royalties[80](index=80&type=chunk) - A companion diagnostic agreement with Akoya Biosciences includes up to **$10.3 million** in potential development milestone payments, with **$2.8 million** paid as of March 31, 2023[81](index=81&type=chunk) - Subsequent to quarter end, ACR-368 received two FDA Fast Track designations for platinum-resistant ovarian and endometrial cancers on May 8, 2023[87](index=87&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's **$12.8 million net loss** in Q1 2023, driven by increased R&D and G&A expenses, and its liquidity position of **$159.5 million** [Results of Operations](index=26&type=section&id=Results%20of%20Operations) Total operating expenses increased by **$7.2 million** to **$14.4 million** in Q1 2023, primarily due to higher R&D and G&A costs Comparison of Operating Results (in thousands) | Item | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | Change | | :--- | :--- | :--- | :--- | | Research and development | $9,758 | $6,068 | $3,690 | | General and administrative | $4,635 | $1,144 | $3,491 | | **Total operating expenses** | **$14,393** | **$7,212** | **$7,181** | | Net loss | $(12,756) | $(7,220) | $(5,536) | - The **$3.7 million** increase in R&D expenses was driven by **$0.9 million** in ACR-368 development costs (including a **$1.5 million** Akoya milestone) and **$2.1 million** in personnel costs[114](index=114&type=chunk) - The **$3.5 million** increase in G&A expenses was primarily due to a **$2.6 million** increase in payroll and **$0.7 million** in legal and professional fees as a public company[115](index=115&type=chunk) [Liquidity and Capital Resources](index=27&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2023, the company held **$159.5 million** in cash and investments, expected to fund operations into Q4 2024, but acknowledges the need for additional capital - As of March 31, 2023, the company held **$159.5 million** in cash, cash equivalents, and investments[117](index=117&type=chunk) - Existing cash is projected to fund operating expenses and capital expenditures at least into Q4 2024[117](index=117&type=chunk)[123](index=123&type=chunk) - Net cash used in operating activities increased to **$11.4 million** in Q1 2023 from **$8.4 million** in Q1 2022, driven by a higher net loss[120](index=120&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a "smaller reporting company," Acrivon Therapeutics is exempt from providing market risk disclosures - The company, as a "smaller reporting company," is not required to provide quantitative and qualitative disclosures about market risk[142](index=142&type=chunk) [Controls and Procedures](index=32&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were ineffective as of March 31, 2023, due to identified material weaknesses, with remediation efforts ongoing - Management concluded that disclosure controls and procedures were not effective as of March 31, 2023, due to previously identified material weaknesses[143](index=143&type=chunk) - Identified material weaknesses include an ineffective control environment, insufficient accounting resources, and ineffective IT general controls and complex transaction accounting[144](index=144&type=chunk) - A remediation plan is underway, involving hiring finance personnel, engaging third-party professionals, and implementing a new financial system[147](index=147&type=chunk)[148](index=148&type=chunk)[149](index=149&type=chunk) Part II [Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings - The company reports no current involvement in any material legal proceedings[155](index=155&type=chunk) [Risk Factors](index=36&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including ongoing losses, capital dependency, reliance on ACR-368 and AP3 platform, regulatory hurdles, third-party reliance, competition, and intellectual property challenges - The company has a history of significant losses, with an **accumulated deficit of $68.8 million** as of March 31, 2023, and expects continued losses[158](index=158&type=chunk) - The business is highly dependent on the success of its lead drug candidate, ACR-368, and its AP3 platform, with program failure posing significant harm[172](index=172&type=chunk)[180](index=180&type=chunk) - Successful development hinges on co-approval of the OncoSignature test as a companion diagnostic, subject to regulatory risks and reliance on Akoya[190](index=190&type=chunk) - Reliance on third-party CROs for clinical trials and CMOs for manufacturing poses substantial business risk if these parties fail[266](index=266&type=chunk)[273](index=273&type=chunk) - The company relies on intellectual property licensed from Eli Lilly for ACR-368, and license termination would result in significant rights loss[353](index=353&type=chunk) - Identified material weaknesses in internal control over financial reporting could impede accurate and timely financial reporting if not remediated[395](index=395&type=chunk)[397](index=397&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=84&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company details **$99.8 million** net proceeds from its November 2022 IPO and **$4.7 million** from a concurrent private placement, with **$10.1 million** used as of March 31, 2023 - The company received **$99.8 million** in aggregate net proceeds from its IPO, before **$3.6 million** in offering expenses[429](index=429&type=chunk) - A concurrent private placement with Chione Limited generated an additional **$4.7 million** in net proceeds[429](index=429&type=chunk) - As of March 31, 2023, **$10.1 million** of the IPO net proceeds had been utilized[430](index=430&type=chunk) [Defaults Upon Senior Securities](index=85&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section is not applicable to the company's current financial reporting requirements [Mine Safety Disclosures](index=85&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section is not applicable to the company's operations or reporting requirements [Other Information](index=85&type=section&id=Item%205.%20Other%20Information) No other material information is required to be disclosed in this section [Exhibits](index=86&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with Form 10-Q, including officer certifications and XBRL data files

Commission File Number 001-41551 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ____________________ TO ____________________ Acrivon Therapeutics, Inc. (Exact name of Registrant as specified in its Charter) | D ...