Investors interested in Medical stocks should always be looking to find the best-performing companies in the group. Acrivon Therapeutics, Inc. (ACRV) is a stock that can certainly grab the attention of many investors, but do its recent returns compare favorably to the sector as a whole? A quick glance at the company's year-to-date performance in comparison to the rest of the Medical sector should help us answer this question.Acrivon Therapeutics, Inc. is a member of our Medical group, which includes 1047 di ...

[Business Highlights](index=1&type=section&id=Business%20Highlights) Acrivon reported significant progress in Q1 2024, highlighted by the prospective validation of its AP3 patient selection platform for the ACR-368 trial, which showed a **50%** confirmed overall response rate (ORR) in OncoSignature-positive patients with ovarian and endometrial cancer, and strengthened its financial position with a **$130 million** oversubscribed private placement - Achieved statistically significant prospective validation of the AP3 patient selection platform with the ACR-368 OncoSignature assay, which effectively identifies cancer patients likely to respond to ACR-368 monotherapy[1](index=1&type=chunk) - In the ongoing Phase 2b trial of ACR-368 for platinum-resistant ovarian or endometrial cancer, a confirmed Overall Response Rate (ORR) of **50%** was observed in the prospectively-defined, OncoSignature-positive patient cohort, clearly segregating responders from the OncoSignature-negative arm (0% ORR), with a p-value of 0.0038[2](index=2&type=chunk)[3](index=3&type=chunk) - Successfully executed an oversubscribed **$130 million** private placement financing at a premium, with support from new and existing healthcare investors[1](index=1&type=chunk)[3](index=3&type=chunk) [Pipeline and Future Outlook](index=2&type=section&id=Pipeline%20and%20Future%20Outlook) The company has accelerated the development of ACR-2316, a dual WEE1/PKMYT1 inhibitor, with an IND submission planned for Q3 2024 and a Phase 1 study initiation in Q4 2024, with further pipeline updates expected in the second half of 2024 and plans to advance a new cell cycle program in 2025 - The timeline for ACR-2316, a potential first-in-class WEE1/PKMYT1 inhibitor, has been accelerated based on compelling preclinical data showing superior activity[1](index=1&type=chunk)[3](index=3&type=chunk) - Key upcoming milestones for 2024 include: - IND submission for ACR-2316 in Q3 2024 - Initiation of a Phase 1 clinical study of ACR-2316 in Q4 2024 - General pipeline and corporate updates in the second half of 2024[4](index=4&type=chunk) - The company plans to advance a new, potential first-in-class cell cycle program for an undisclosed target towards development candidate nomination in 2025[4](index=4&type=chunk) [First Quarter 2024 Financial Results](index=2&type=section&id=First%20Quarter%202024%20Financial%20Results) For the first quarter of 2024, Acrivon reported a net loss of **$16.5 million**, an increase from **$12.8 million** in the prior year's quarter, driven by higher R&D and G&A expenses, and as of March 31, 2024, the company held **$110 million** in cash and equivalents, which, combined with a subsequent **$130 million** financing, is expected to fund operations into the second half of 2026 Q1 2024 Statement of Operations Highlights (vs. Q1 2023) | Financial Metric | Q1 2024 (in thousands) | Q1 2023 (in thousands) | Change | | :--- | :--- | :--- | :--- | | Research and Development | $11,473 | $9,758 | +17.6% | | General and Administrative | $6,195 | $4,635 | +33.7% | | **Net Loss** | **$(16,486)** | **$(12,756)** | **+29.2%** | | Net Loss Per Share | $(0.73) | $(0.58) | +25.9% | - The increase in R&D expenses was primarily due to the continued development of ACR-368 and increased personnel costs, while the rise in G&A expenses was mainly due to higher personnel costs, including non-cash stock compensation[5](index=5&type=chunk) Balance Sheet and Cash Position | Metric | As of March 31, 2024 | Note | | :--- | :--- | :--- | | Cash, Cash Equivalents & Marketable Securities (in millions) | $110 | Prior to April 2024 financing | | April 2024 Private Placement (gross proceeds, in millions) | $130 | Not included in March 31 balance | | **Cash Runway** | **Into 2H 2026** | Includes proceeds from financing | [Company Overview](index=2&type=section&id=About%20Acrivon%20Therapeutics) Acrivon is a clinical-stage biopharmaceutical company focused on precision oncology, utilizing its proprietary proteomics platform, AP3, to match patients with targeted therapies, with its lead candidate, ACR-368, in a Phase 2 trial for ovarian and endometrial cancer and having received FDA Fast Track designation, while its preclinical pipeline includes ACR-2316 and another undisclosed cell cycle program - Acrivon's core technology is its proprietary Acrivon Predictive Precision Proteomics (AP3) platform, used to identify patients most likely to benefit from its drug candidates by creating drug-specific OncoSignature companion diagnostics[7](index=7&type=chunk) - The lead candidate, ACR-368 (prexasertib), is a selective CHK1/CHK2 inhibitor in a potentially registrational Phase 2 trial, having received FDA Fast Track designation for use in patients with platinum-resistant ovarian or endometrial cancer identified via its OncoSignature test[7](index=7&type=chunk) - The preclinical pipeline includes ACR-2316, a potent and selective WEE1/PKMYT1 inhibitor, and an undisclosed cell cycle program, both developed using the AP3 platform[7](index=7&type=chunk)

[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)

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]

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 frender / iStock via Getty Images At the end of the previous week, the Oracle of Omaha yet again boosted his stake in a media giant’s tracking stocks, even with shares still in retreat. Meanwhile, a couple of industrials and a couple of biotechs also saw notable insider purchases made in the past week. Overall, insider buying has slowed.A well-known adage reminds us that corporate insiders and 10% owners really only buy shares of a compan ...

WATERTOWN, Mass., April 16, 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 it will be holding a virtual corporate R&D even ...

Acrivon Therapeutics (NASDAQ:ACRV) stock is rocketing higher on Tuesday after the clinical-stage biopharmaceutical company announced a $130 million private placement.This new funding comes from a private investment in public equity (PIPE) with existing and new accredited investors. This has the company selling 8,235,000 shares of ACRV stock for $8.50 per share.The offer also includes pre-funded warrants for 7,060,000 shares being sold for $8.49 each. The exercise price for these warrants is one penny. They ...

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 ...

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