Acrivon Therapeutics(ACRV)

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Acrivon Therapeutics(ACRV) - 2023 Q1 - Quarterly Report
2023-05-08 16:00
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
Acrivon Therapeutics(ACRV) - 2022 Q4 - Annual Report
2023-03-27 16:00
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 ...