Acrivon Therapeutics(ACRV)
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Acrivon Therapeutics(ACRV) - 2024 Q1 - Quarterly Report
2024-05-14 11:31
[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Unaudited Q1 2024 financials show decreased assets, a wider net loss, and a significant post-quarter financing event [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $120.5 million as of March 31, 2024, from $138.3 million at the end of 2023 Condensed Consolidated Balance Sheets (in thousands) | Account | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $24,607 | $36,015 | | Short-term investments | $85,368 | $91,443 | | Total current assets | $112,143 | $129,692 | | Total assets | $120,521 | $138,265 | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $9,041 | $13,303 | | Total liabilities | $12,542 | $17,070 | | Total stockholders' equity | $107,979 | $121,195 | | Total liabilities and stockholders' equity | $120,521 | $138,265 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The net loss for Q1 2024 increased to $16.5 million, compared to $12.8 million in the prior-year period Statement of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Research and development | $11,473 | $9,758 | | General and administrative | $6,195 | $4,635 | | Total operating expenses | $17,668 | $14,393 | | Loss from operations | ($17,668) | ($14,393) | | Net loss | ($16,486) | ($12,756) | | Net loss per share—basic and diluted | ($0.73) | ($0.58) | [Condensed Consolidated Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) Stockholders' equity declined to $108.0 million, primarily driven by the quarterly net loss of $16.5 million - The primary driver for the decrease in stockholders' equity during Q1 2024 was the **net loss of $16.5 million**[15](index=15&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to $17.1 million, contributing to an overall $11.4 million decrease in cash Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | ($17,083) | ($11,357) | | Net cash provided by investing activities | $5,850 | $9,327 | | Net cash used in financing activities | ($172) | $0 | | Net decrease in cash, cash equivalents, and restricted cash | ($11,405) | ($2,030) | [Notes to the Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) Notes provide context on clinical operations, liquidity, and a key $130 million post-quarter financing - The company is a clinical-stage biopharmaceutical company advancing its lead candidate, **ACR-368**, a selective small molecule inhibitor targeting CHK1 and CHK2, in a Phase 2 trial[20](index=20&type=chunk) - As of March 31, 2024, the company had an **accumulated deficit of $132.9 million** and expects existing cash combined with **$130.0 million in gross proceeds** from a recent private placement to fund operations for at least 12 months[23](index=23&type=chunk)[25](index=25&type=chunk) - The company has a license agreement with Eli Lilly for ACR-368, which includes potential future milestone payments of **up to $168.0 million**[60](index=60&type=chunk)[61](index=61&type=chunk) - In April 2024, the company closed a Private Investment in Public Equity (PIPE) financing, receiving aggregate **gross proceeds of $130.0 million**[70](index=70&type=chunk)[71](index=71&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=17&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management analyzes its precision oncology strategy, Q1 2024 results, and liquidity following a $130 million financing [Overview](index=17&type=section&id=Overview) The company is advancing its lead candidate ACR-368 in a Phase 2 trial and preparing its preclinical candidate ACR-2316 for IND filing - The company's lead candidate, **ACR-368**, is being evaluated in a potentially registrational Phase 2 trial for platinum-resistant ovarian cancer, endometrial adenocarcinoma, and urothelial cancer[76](index=76&type=chunk) - Initial clinical data from the Phase 2 trial showed a **50% confirmed Objective Response Rate (ORR)** in OncoSignature-positive patients, providing prospective validation for the OncoSignature test[79](index=79&type=chunk) - The preclinical candidate **ACR-2316**, a WEE1/PKMYT1 inhibitor, is advancing rapidly, with an IND filing expected in Q3 2024 and clinical trial initiation in Q4 2024[81](index=81&type=chunk) [Results of Operations](index=22&type=section&id=Results%20of%20Operations) The net loss widened to $16.5 million in Q1 2024, driven by increased R&D and G&A expenses Comparison of Results of Operations (in thousands) | Item | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Change | | :--- | :--- | :--- | :--- | | Research and development | $11,473 | $9,758 | $1,715 | | General and administrative | $6,195 | $4,635 | $1,560 | | Loss from operations | ($17,668) | ($14,393) | ($3,275) | | Net loss | ($16,486) | ($12,756) | ($3,730) | - The **$1.7 million increase in R&D expenses** was primarily due to a $0.8 million increase in costs for the ACR-368 clinical trial and a $0.9 million increase in personnel-related costs[103](index=103&type=chunk) - The **$1.6 million increase in G&A expenses** was mainly driven by a $1.1 million increase in payroll and employee-related expenses, including $0.6 million in stock-based compensation[106](index=106&type=chunk) [Liquidity and Capital Resources](index=23&type=section&id=Liquidity%20and%20Capital%20Resources) A $130 million private placement in April 2024 extends the company's projected cash runway into the second half of 2026 - The company had **$110.0 million in cash, cash equivalents, and investments** as of March 31, 2024[108](index=108&type=chunk) - In April 2024, the company raised **$130.0 million in gross proceeds** from a PIPE financing, significantly strengthening its balance sheet[108](index=108&type=chunk) - With the recent financing, the company projects its **cash runway will extend into the second half of 2026**[113](index=113&type=chunk) - **Net cash used in operating activities increased to $17.1 million** for Q1 2024, compared to $11.4 million for Q1 2023, primarily due to an increased net loss[109](index=109&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=27&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exempt from this disclosure requirement as a "smaller reporting company" - As a **"smaller reporting company,"** Acrivon is exempt from providing quantitative and qualitative disclosures about market risk[128](index=128&type=chunk) [Item 4. Controls and Procedures](index=27&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective with no material changes to internal controls - The company's management, including the CEO and CFO, concluded that **disclosure controls and procedures were effective** as of the end of the period covered by the report[129](index=129&type=chunk) - There were **no changes in internal control over financial reporting** during the quarter ended March 31, 2024, that have materially affected, or are reasonably likely to materially affect, internal controls[131](index=131&type=chunk) [PART II. OTHER INFORMATION](index=28&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=28&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - The company is **not currently subject to any material legal proceedings**[133](index=133&type=chunk) [Item 1A. Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors) Key risks include a history of operating losses, the need for additional funding, and potential stock price dilution - The company has a history of significant losses, with an **accumulated deficit of $132.9 million** as of March 31, 2024, and expects to incur losses for the foreseeable future[135](index=135&type=chunk) - **Substantial additional funding will be required** to meet financial obligations; the current cash runway is projected to last into the second half of 2026[140](index=140&type=chunk)[141](index=141&type=chunk) - A significant number of shares may be sold in the near future, which could cause the **market price of the common stock to drop**[144](index=144&type=chunk)[146](index=146&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=31&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered securities were sold during the quarter, and $59.7 million of IPO net proceeds have been utilized to date - There were **no sales of unregistered securities** during the reported period[146](index=146&type=chunk) - As of March 31, 2024, the company had used **$59.7 million of the net proceeds from its IPO**, and the planned use of these proceeds has not materially changed[147](index=147&type=chunk) [Item 3. Defaults Upon Senior Securities](index=32&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable to the company - Not applicable[148](index=148&type=chunk) [Item 4. Mine Safety Disclosures](index=32&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[148](index=148&type=chunk) [Item 5. Other Information](index=32&type=section&id=Item%205.%20Other%20Information) The company appointed Katharine Peterson as Vice President of Finance and Chief Accounting Officer - Effective May 13, 2024, **Katharine Peterson was appointed as Vice President of Finance and Chief Accounting Officer**, and will serve as the company's Principal Accounting Officer[149](index=149&type=chunk) [Item 6. Exhibits](index=33&type=section&id=Item%206.%20Exhibits) This section lists required officer certifications and Inline XBRL documents filed with the report - The report includes **certifications from the CEO and CFO** pursuant to Sarbanes-Oxley Act Sections 302 and 906, along with Inline XBRL data files[152](index=152&type=chunk)
Is a Surprise Coming for Acrivon Therapeutics (ACRV) This Earnings Season?
Zacks Investment Research· 2024-05-10 13:51
Core Insights - Acrivon Therapeutics, Inc. (ACRV) is anticipated to report earnings soon, with favorable conditions suggesting a potential earnings beat [1] - Recent earnings estimate revisions indicate positive trends for ACRV, as analysts have raised their estimates ahead of the earnings report [1] - The Most Accurate Estimate for ACRV's current quarter is a loss of 79 cents per share, which is an improvement compared to the Zacks Consensus Estimate of a loss of 89 cents per share [1] Earnings ESP Analysis - Acrivon Therapeutics has a Zacks Earnings ESP of +11.63%, indicating a positive outlook heading into the earnings season [1] - A positive Zacks Earnings ESP has historically led to positive surprises and outperformance in the market, with a nearly 70% success rate in producing positive surprises [2] - Stocks with a positive Earnings ESP and a Zacks Rank of 3 or better have shown an average annual return of over 28% [2]
Acrivon Therapeutics Reports Initial Positive Clinical Data for ACR-368 and Pipeline Program Progress Today at Corporate R&D Event
Newsfilter· 2024-04-24 20:01
Core Insights - Acrivon Therapeutics presents initial positive clinical data from the Phase 2 ACR-368 trial, showing a 50% confirmed overall response rate in OncoSignature-positive patients with ovarian and endometrial cancers [1][3] - The AP3 patient selection platform has demonstrated its ability to predict responders to ACR-368 treatment, with a statistically significant p-value of 0.0038 [1][3] - ACR-2316, a potential first-in-class dual WEE1/PKMYT1 inhibitor, has an accelerated IND filing timeline now expected in Q3 2024 [1][4] Clinical Data Highlights - Initial clinical data from the ongoing Phase 2b trial includes 26 patients, with 10 OncoSignature-positive and 16 OncoSignature-negative [1][3] - A confirmed overall response rate of 50% was observed in OncoSignature-positive patients, while no responders were found in the OncoSignature-negative group [3][4] - The median duration of response has not yet been reached, and all confirmed responders continue treatment [3] AP3 Platform Validation - The ACR-368 OncoSignature assay has shown prospective validation in identifying patients likely to respond to ACR-368 monotherapy [2][3] - The assay effectively segregated RECIST responders, confirming a 50% overall response rate in OncoSignature-positive patients compared to 0% in OncoSignature-negative patients [3] ACR-2316 Development - ACR-2316 is designed for superior single-agent activity and is advancing rapidly, with IND filing now expected in Q3 2024 and clinical trial initiation anticipated in Q4 2024 [1][4] - The compound aims to address significant unmet treatment needs across a broad range of tumors [2][4] Event and Presentation - Acrivon hosted a corporate R&D event to present these findings, with a live and recorded webcast available for investors [5]
Buffett Grabs More of This Stock, Plus Other Notable Insider Buying
24/7 Wall Street· 2024-04-21 12:45
Core Insights - Warren Buffett's Berkshire Hathaway has increased its stake in Liberty Media Corp, acquiring over 1.3 million shares at prices ranging from $25.36 to $26.55, totaling more than $29.3 million, bringing its total holdings to approximately 69 million shares [4][6] - Insider buying activity has generally slowed, but notable purchases were made in various sectors, including media, biotechnology, and industrials [1][19] Liberty Media - Berkshire Hathaway has boosted its stake in Liberty Media Corp (NASDAQ: LSXMK) to around 69 million shares after a previous purchase of over $66 million [4] - The stock price of Liberty Media has decreased by about 15% since the beginning of the year, and the company is in the process of merging with Sirius XM Holdings Inc [4][6] Acrivon Therapeutics - Perceptive Advisors purchased over 2.3 million shares of Acrivon Therapeutics Inc (NASDAQ: ACRV) at $8.50 per share, totaling around $20 million [9] - The stock has risen over 114% since the start of the year, largely due to a $130 million funding announcement, with a mean price target suggesting an additional upside of approximately 84% [9] UL Solutions - Insiders, including CEO Jennifer Scanlon, bought more than 590,600 shares of UL Solutions Inc (NYSE: ULS) at $28.00 per share, costing over $16.5 million [12] - The shares were last seen trading around $34, indicating a positive post-IPO performance despite recent market fluctuations [12] OncoCyte - Broadway Partners and other insiders acquired nearly 2.5 million shares of OncoCyte Corp (NASDAQ: OCX) at prices between $2.91 and $2.95, totaling over $7.1 million [14] - The stock has declined almost 25% in the past 90 days, but remains above its 52-week low of $2.08, with a consensus price target of $3.90 [14] GrafTech International - Colonial House Capital purchased around 2.3 million shares of GrafTech International Ltd (NYSE: EAF) at $1.78 per share, costing about $4.1 million [17] - The stock has fallen more than 32% year-to-date, with a consensus price target of $1.75, indicating limited analyst support for buying shares [17] Other Notable Insider Buying - Recent insider purchases were reported at companies including AES, America's Car-Mart, Federal Agricultural Mortgage, Lovesac, Neogen, Rocket Companies, RXO, SAIC, Walgreens Boots Alliance, and WD-40 [19]
Acrivon Therapeutics to Host Corporate R&D Event Highlighting AP3 and Pipeline Progress, Including Ongoing Prospective Validation of ACR-368 OncoSignature with Initial Phase 2 Data for ACR-368, and Preclinical Progress for ACR-2316
Newsfilter· 2024-04-17 00:01
Core Insights - Acrivon Therapeutics is hosting a virtual corporate R&D event on April 24, 2024, to present updates on its precision oncology pipeline and engage in an interactive Q&A session [1][2] Company Overview - Acrivon Therapeutics is a clinical stage biopharmaceutical company focused on developing precision oncology medicines using its proprietary platform, Acrivon Predictive Precision Proteomics (AP3), which identifies patients whose tumors are likely to respond to specific treatments [3] - The AP3 platform measures compound-specific effects on tumor cell protein signaling networks and drug-induced resistance mechanisms, facilitating drug design optimization and the creation of proprietary OncoSignature companion diagnostics [3] Pipeline Developments - 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 based on OncoSignature-predicted sensitivity [3] - The ACR-368 OncoSignature test, which is not yet approved, has been evaluated in preclinical studies, including two blinded, prospectively-designed studies involving tumor biopsies from previous trials [3] - The FDA has granted Breakthrough Device designation for the ACR-368 OncoSignature assay to identify ovarian cancer patients who may benefit from ACR-368 treatment [3] - Acrivon is also developing ACR-2316, a potent WEE1/PKMYT1 inhibitor, and other preclinical programs leveraging the AP3 platform [3]
ACRV Stock Jumps 55% as Acrivon Therapeutics Gets $130 Million Boost
InvestorPlace· 2024-04-09 14:32
Group 1 - Acrivon Therapeutics announced a $130 million private placement to fund its product pipeline development [1] - The company sold 8,235,000 shares at $8.50 per share and pre-funded warrants for 7,060,000 shares at $8.49 each [1] - The funding will support the development of ACR-368, ACR-2316, and an undisclosed cell cycle regulatory program [2] Group 2 - ACRV stock surged by 54.9% with over 14 million shares traded, significantly above its average daily volume of about 73,000 shares [2] - The investment comes from notable healthcare and life sciences investors, including RA Capital Management and Perceptive Advisors [1]
Acrivon Therapeutics Announces $130 Million Private Placement Financing
Newsfilter· 2024-04-09 11:00
WATERTOWN, Mass, April 09, 2024 (GLOBE NEWSWIRE) -- 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 announced that it has entered into a securities purchase a ...
What To Buy After You Sell The Russell 2000
Seeking Alpha· 2024-04-03 07:07
Core Viewpoint - There is a strong argument for investing in small cap stocks currently, but a recommendation to exit the Russell 2000 and related ETFs due to underperformance and seasonal factors is emphasized [2][8]. Group 1: Small Cap Stocks vs. Large Cap Stocks - Anticipated easing by the Federal Reserve may benefit small cap stocks more than large caps [2]. - Small caps have historically underperformed large caps over the past five years, suggesting a potential for mean reversion [2]. - The recent tech rally has disproportionately favored large cap indices like the S&P 500, indicating a possible slowdown [2]. Group 2: Performance Metrics - From 2016 to 2023, the Russell 2000 underperformed the S&P 500 by 28.4% during the months of May to August [2]. - Year-to-date returns show the Russell 2000 at 10.16%, while the S&P 500 has higher returns [3]. - Over the past year, the Russell 2000 has returned 27.88%, compared to 15.93% for the S&P 600 [3]. Group 3: Comparison of Small Cap Indices - The Russell 2000 has the largest company market cap at $46 billion, while the S&P 600's largest is $7 billion [5]. - The Russell 2000 has no restrictions on IPOs, leading to a more volatile composition compared to the S&P 600 and CRSP [5]. - The S&P 600 requires positive earnings for inclusion, which may lead to stronger balance sheets compared to the Russell 2000 [5][9]. Group 4: Recommended ETFs and Funds - IWM, which tracks the Russell 2000, is recommended for exit, while IJR (S&P 600) and VB (CRSP) are suggested alternatives [6][8]. - AVUV, an actively managed small cap value ETF, has shown superior returns compared to the Russell 2000 Value Index [6][7]. - DFSV, another actively managed ETF, has also performed well but is recommended to be less favorable than AVUV [7]. Group 5: Conclusion - Investors should consider switching from Russell 2000 tracking investments to alternatives like IJR, VB, or AVUV based on their investment preferences and market outlook [8].
Acrivon Therapeutics(ACRV) - 2023 Q4 - Annual Results
2024-03-28 12:00
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, A ...
Acrivon Therapeutics(ACRV) - 2023 Q4 - Annual Report
2024-03-28 11:36
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, 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) | D ...