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14-05-2025
- Business
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Acrivon Therapeutics Reports First Quarter 2025 Financial Results and Business Highlights
Corporate R&D event highlighted positive ACR-368 data in endometrial cancer patients who had all received prior anti-PD-1 and platinum-based chemotherapy Confirmed overall response rate (cORR) of 35% and median duration of response (mDOR) >5.6 months (not yet reached) observed in OncoSignature-positive (BM+) patients, a majority of whom were refractory to last prior therapy, and cORR of 50% and mDOR >10 months (not yet reached) for BM+ patients who had relapsed on last prior therapy Three dose escalation cohorts completed in ACR-2316 Phase 1 trial with tumor shrinkage observed already at dose level (DL)3, below projected recommended Phase 2 dose AACR presentation of ACR-2316 revealing mechanisms underlying its superior preclinical activity with potent mitotic tumor cell death using AP3 Generative Phosphoproteomics Mansoor Raza Mirza, M.D. appointed chief medical officer; accomplished clinician with stellar track record of successfully leading registrational trials through regulatory approvals, and establishing new standards of care in gynecological oncology Cash, cash equivalents and marketable securities of $164.8 million as of March 31, 2025, expected to fund operations into the second quarter of 2027 WATERTOWN, Mass., May 14, 2025 (GLOBE NEWSWIRE) -- Acrivon Therapeutics, Inc. ('Acrivon' or 'Acrivon Therapeutics') (Nasdaq: ACRV), a clinical stage biotechnology company discovering and developing precision oncology medicines utilizing its proprietary Generative Phosphoproteomics AP3 (Acrivon Predictive Precision Proteomics) platform designed to interpret and quantify compound specific, drug-regulated pathway activity levels inside the intact cell in an unbiased and actionable manner, today reported financial results for the first quarter ended March 31, 2025 and reviewed recent business highlights. 'We made substantial progress in the first quarter in the advancement of our clinical pipeline and the expansion of our Generative Phosphoproteomics AP3 capabilities, as well as strengthening the executive team,' said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and founder of Acrivon. 'At our corporate R&D event, we reported positive updated interim data from our ongoing ACR-368 Phase 2b study in endometrial cancer patients with large tumors and aggressive histopathologies – all of whom had progressed after prior platinum-based chemotherapy and anti-PD-1. With a significant unmet need for second-line treatment options and the potential for label expansion through a confirmatory trial in the front-line setting with ACR-368 used as switch maintenance, we remain very excited by the opportunities for this program. For our second clinical-stage asset, ACR-2316, we have observed tumor shrinkage (~25%) in a patient with significant metastatic solid tumor burden after only six weeks of treatment at dose level 3 - well before reaching our projected RP2D, supporting its potential for monotherapy activity. Finally, we are thrilled and feel privileged that Dr. Mansoor Raza Mirza, a globally recognized oncologist, is now leading the development of our pipeline as CMO. Mansoor has made significant contributions in clinical oncology as a lead investigator for multiple approved drugs and senior author of national cancer guidelines.' Recent Highlights Presented interim data (February 25, 2025) from the ongoing Phase 2b registrational-intent trial of ACR-368 in patients with heavily pretreated endometrial cancer who had all progressed on prior anti-PD-1 and chemotherapy Among the 20 OncoSignature-positive (BM+) patients, the confirmed overall response rate (cORR) was 35%, more than double that in the prior line of therapy, and the disease control rate (DCR) was 80% In the BM+ patients that had relapsed after the prior line of therapy, the cORR was 50%, mDOR was not yet reached (>10 months), and DCR was 100% In the BM+ patients with tumors refractory to last prior line of therapy, significant clinical activity was observed with a cORR of 33% and DCR of 75% Provided an overview of the expanded capabilities of the company's Generative Phosphoproteomics AP3 platform highlighting the growing suite of powerful, internally-developed tools, including the AP3 Data Portal, designed to convert multimodal data into structured data for generative AI analyses, the AP3 Kinase Substrate Relationship Predictor, and the AP3 Interactome. These distinctive capabilities enable the company to go beyond the limitations of traditional drug discovery, as well as current AI-based target-centric drug discovery and rapidly design highly differentiated compounds with desirable pathway effects through intracellular protein network analyses and advance these agents into the clinic for streamlined development. Advanced to DL4 in the Phase 1 monotherapy clinical trial of ACR-2316, with encouraging observations at DLs 1-3: DL 1, 2, and 3 cleared without safety concerns or dose-limiting toxicities (DLTs) by the safety review committee, and DL4 is now enrolling Drug target engagement observed at DL1 and 2 using the company's clinical mass-spectrometry-based AP3 profiling, with evidence of approximate dose proportionality based on plasma pharmacokinetic analyses Notably, initial clinical activity of ~25% RECIST tumor shrinkage and a reduction of metastatic lesions throughout the chest, abdomen and pelvis was observed after six weeks of treatment in a patient at DL3 (below projected RP2D) who had received three prior lines of therapy including chemotherapy and anti-PD1 Presented at the AACR Annual Meeting Generative Phosphoproteomic AP3 analyses uncovering key molecular mechanisms by which ACR-2316 induces strong mitotic and replicative tumor cell death believed to be critical for its potent single-agent activity Appointed Mansoor Raza Mirza, M.D., as chief medical officer, bringing decades of experience as a distinguished and highly accomplished oncology key opinion leader with a stellar track record of successfully leading numerous registrational trials through global regulatory approvals, and establishing new standards of care in gynecological oncology Promoted Adam D. Levy, Ph.D., M.B.A., to chief financial officer, having served as the company's head of investor relations and with prior finance and strategy leadership roles at Zentalis Pharmaceuticals, Turning Point Therapeutics, Novartis, Gilead, and McKinsey & Company Anticipated Upcoming Milestones Provide update on registrational-intent trial and confirmatory trial design for ACR-368 Report initial clinical data from the Phase 1 clinical study of ACR-2316 in the second half of 2025 Advance a new potential first-in-class cell cycle drug discovery program for an undisclosed target towards development candidate nomination in 2025 First Quarter 2025 Financial Results Net loss for the quarter ended March 31, 2025 was $19.7 million compared to a net loss of $16.5 million for the same period in 2024. Research and development expenses were $15.4 million for the quarter ended March 31, 2025 compared to $11.5 million for the same period in 2024. The difference was primarily due to the continued execution of the clinical trials for ACR-368 and ACR-2316, as well as preclinical drug discovery advancement and increased personnel to support these research and development activities. General and administrative expenses were $6.2 million for the quarter ended March 31, 2025, which is materially consistent with the same period in 2024. As of March 31, 2025, the company had cash, cash equivalents and investments of $164.8 million, which is expected to fund operating expenses and capital expenditure requirements into the second quarter of 2027. About Acrivon Therapeutics Acrivon is a clinical stage biopharmaceutical company discovering and developing precision oncology medicines utilizing its proprietary Generative Phosphoproteomics AP3 platform. The platform allows the company to interpret and quantify compound specific, drug-regulated pathway activity levels inside the intact cell in an unbiased manner, yielding terabytes of proprietary data and delivering rapid, actionable insights. The Generative Phosphoproteomics AP3 platform is comprised of a growing suite of powerful, internally-developed tools, including the AP3 Data Portal, converting multimodal data into structured data for generative AI analyses, the AP3 Kinase Substrate Relationship Predictor and the AP3 Interactome. These distinctive capabilities enable the company to go beyond the limitations of traditional drug discovery, as well as current AI-based target-centric drug discovery, and rapidly design highly differentiated compounds with desirable pathway effects through intracellular protein network analyses and advance these agents into the clinic for streamlined development. Acrivon is currently advancing its lead program, ACR-368 (also known as prexasertib), a selective small molecule inhibitor targeting CHK1 and CHK2 in a potentially registrational Phase 2 trial for endometrial cancer. The company has received Fast Track designation from the Food and Drug Administration, or FDA, for the investigation of ACR-368 as a monotherapy based on OncoSignature-predicted sensitivity in patients with endometrial cancer. The FDA has granted a Breakthrough Device designation for the ACR-368 OncoSignature assay for the identification of patients with endometrial cancer who may benefit from ACR-368 treatment. In addition to ACR-368, Acrivon is also leveraging its proprietary Generative Phosphoproteomics AP3 platform for developing its co-crystallography-driven, internally discovered pipeline programs. These include ACR-2316, the company's second clinical stage asset, a novel, potent, selective WEE1/PKMYT1 inhibitor designed for superior single-agent activity through strong activation of not only CDK1 and CDK2, but also of PLK1 to drive pro-apoptotic cell death, as observed in preclinical studies against benchmark inhibitors. The Phase 1 trial of ACR-2316 is advancing with enrollment in the first three dose-escalation cohorts completed. Drug target engagement was observed at DL1 and 2 using the company's clinical mass-spectrometry-based AP3 profiling, with evidence of approximate dose proportionality based on plasma pharmacokinetic analyses, and initial clinical activity with tumor shrinkage observed at DL3. The company also has a preclinical 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, preclinical and clinical results, 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., Alexandra Santos asantos@ Acrivon Therapeutics, Consolidated Statements of Operations and Comprehensive Loss(unaudited, in thousands, except share and per share data) Three Months Ended March 31, 2025 2024 Operating expenses: Research and development $ 15,414 $ 11,473 General and administrative $ 6,248 $ 6,195 Total operating expenses 21,662 17,668 Loss from operations (21,662 ) (17,668 ) Other income (expense), net: Interest income 1,996 1,446 Other expense, net (14 ) (264 ) Total other income, net 1,982 1,182 Net loss $ (19,680 ) $ (16,486 ) Net loss per share - basic and diluted $ (0.51 ) $ (0.73 ) Weighted-average common stock outstanding – basic and diluted 38,350,444 22,590,804 Comprehensive loss: Net loss $ (19,680 ) $ (16,486 ) Other comprehensive income (loss): Unrealized (loss) gain on available-for-sale investments, net of tax (164 ) 13 Comprehensive loss $ (19,844 ) $ (16,473 )Acrivon Therapeutics, Consolidated Balance Sheets(unaudited, in thousands) March 31, December 31, 2025 2024 Assets Cash and cash equivalents $ 39,154 $ 39,818 Investments 125,676 $ 144,751 Other assets 11,519 $ 12,019 Total assets $ 176,349 $ 196,588 Liabilities and Stockholders' Equity Liabilities 15,959 19,802 Stockholders' Equity 160,390 176,786 Total Liabilities and Stockholders' Equity $ 176,349 $ 196,588 Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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27-03-2025
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Acrivon Therapeutics Provides Program Updates and Fourth Quarter and Full Year 2024 Financial Results
Generative Phosphoproteomics AP3 platform designed to enable streamlined, rational drug discovery, with proprietary, proteome-wide SAR delivering desirable pathway effects R&D event highlighted positive ACR-368 endometrial cancer data in OncoSignature-positive (BM+) patients with heavily pretreated aggressive tumors, and who had all progressed on prior anti-PD-1 and chemotherapy, with 35% confirmed overall response rate (cORR), which is >2-fold higher than last prior line of therapy (15%) In the BM+ patients who had relapsed after prior anti-PD-1 and chemotherapy, the cORR was 50% with the median duration of response (mDOR) not yet reached (>10 months), while in BM+ patients who were refractory to their last prior line of therapy, the cORR was 33% and mDOR was ~3.4 months Endometrial cancer prioritized given limited treatment options and compelling commercial opportunity; represents first potential regulatory approval opportunity for ACR-368 Phase 1 trial of ACR-2316 ahead of schedule with enrollment in first three dose-escalation cohorts completed; initial clinical activity with tumor shrinkage already observed at dose level three Cash runway extended into 2027 WATERTOWN, Mass., March 27, 2025 (GLOBE NEWSWIRE) -- Acrivon Therapeutics, Inc. ('Acrivon' or 'Acrivon Therapeutics') (Nasdaq: ACRV), a clinical stage precision medicine company utilizing its Acrivon Predictive Precision Proteomics (AP3) platform for the discovery, design, and development of drug candidates through a mechanistic match to patients whose disease is predicted sensitive to the specific treatment, today reported financial results for the fourth quarter and full year ended December 31, 2024 and reviewed recent business highlights. 'We continue executing our highly differentiated Generative Phosphoproteomics AP3-enabled strategy, delivering rapid progress towards key milestones across all programs, including our clinical assets, ACR-368 and ACR-2316,' said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and founder of Acrivon. 'We previously identified endometrial cancer as a sensitive tumor type with our AP3 platform prior to clinical entry. At our recent R&D event, we shared positive data for ACR-368 in patients with stage III/IV endometrial cancer who had all progressed after prior anti-PD-1 and chemotherapy. Despite patients presenting with large, heavily pretreated tumors (including 65% treated with prior pembrolizumab and lenvatinib) with aggressive histopathologies (75% serous or carcinosarcomas), pMMR, and p53 mutations, we observed strong anti-tumor activity, both among refractory and relapsed patients. Interestingly, amongst the patients that had relapsed after their last prior line, we observed 50% cORR and mDOR (not yet reached) of greater than 10 months, and 33% cORR in refractory patients who did not respond at all to their last prior line of therapy. In our ACR-2316 Phase 1 trial, we have completed enrollment in the first three dose-escalation cohorts, and have observed approximate dose proportionality, target engagement, and initial clinical activity with significant tumor shrinkage already at dose level three. Finally, we continue to expand the actionable capabilities of our Generative Phosphoproteomics AP3 platform to enable us to optimize therapeutic compounds for desired pathway effects, which drives our streamlined drug discovery, design and development.' Program Updates Presented at Corporate R&D Event on March 25, 2025 Reviewed continued expansion of the differentiated capabilities of the Generative Phosphoproteomics AP3 platform, highlighting the growing suite of powerful, internally-developed tools, including the AP3 Interactome, the AP3 Kinase Substrate Relationship Predictor, the AP3 Data Portal and the AP3 Chatbot. Together, these proprietary tools have enabled the company to go beyond the limitations of traditional drug discovery to rapidly design and advance innovative agents into clinical development. Presented data (from February 25, 2025) from the ongoing Phase 2b registrational-intent trial of ACR-368 that included 20 BM+ endometrial cancer patients treated with ACR-368 monotherapy and 38 BM- patients treated with ACR-368 plus ultra-low dose gemcitabine (LDG) that were efficacy-evaluable by RECIST (2 BM- had treatment discontinued without scan) All BM+ patients had progressed after prior platinum-based chemotherapy and prior anti-PD-1, and the median and mean prior lines of therapy for these patients were 2 and 2.6, respectively. A majority of these BM+ patients were refractory to the last prior line of therapy, with aggressive, generally heavily pre-treated tumors: 12 had refractory disease (best overall response of PD in last prior line of therapy), 6 had relapsed disease, and 2 were unknown. Among the 20 BM+ patients, 15 were either serous or carcinosarcomas, 13 were pMMR (2 deficient DNA mismatch repair, 5 not tested), and 11 had p53 mutations (3 wild-type; 6 unknown) The ACR-368 OncoSignature assay accurately identified patients whose tumors are sensitive to ACR-368, with 80% of BM+ patients demonstrating tumor shrinkage. Among all 20 BM+ patients, the cORR was 35%, more than double than in the prior line of therapy, and the disease control rate (DCR) was 80%. In patients that had relapsed after the prior line of therapy (N=6), the cORR was 50%, mDOR was not yet reached (>10 months), and DCR was 100%. In the 12 patients with tumors refractory to last prior line of therapy (ORR = 0%), significant clinical activity was observed with a cORR of 33% and DCR of 75%. In BM- patients treated with the ACR-368 + LDG combination, cORR was ~13%, which is comparable to the best overall response rate in the last prior line of therapy (median = 3), which was 17%. The totality of the preclinical and observed clinical data support significant LDG sensitization to ACR-368 in BM- patients. The company expects that a similar sensitization would occur in BM+ patients, which could be explored in a future all-comer study of ACR-368 + LDG. Several case studies were presented with imaging showing clinically significant, powerful tumor shrinkage in endometrial cancer patients treated with ACR-368 Given encouraging, maturing data in endometrial cancer, combined with limited treatment options for second-line therapy (standard of care ORR of 10-12% and mPFS of ~3 months, based on estimates from key opinion leaders and derived from control arms of past Phase 2 trials), and potential market opportunity, the company is prioritizing endometrial cancer, reallocating all clinical resources to ACR-368 in endometrial cancer and ACR-2316 Due to increased competition and a smaller market opportunity, the company set a high internal clinical bar for ovarian cancer, which preliminary data suggests is unlikely to be met Bladder cancer is also being deprioritized due to lower than preclinically predicted BM+ rate, leading to enrollment challenges Continued dosing of patients with a certain advanced solid tumors in the ongoing Phase 1 monotherapy clinical trial of ACR-2316 (initiated 2 quarters ahead of original timelines). ACR-2316 was uniquely designed by AP3 to overcome the limitations of current WEE1 and PKMYT1 inhibitors, for superior therapeutic index, and for potent single-agent activity. Dose levels 1 and 2 were cleared without safety concerns or dose-limiting toxicities (DLTs) by the safety review committee; dose level 3 is fully enrolled and the safety observation period is anticipated to be completed by April 1 Encouraging early observations include: evidence of approximate dose proportionality, based on pharmacokinetic analyses of the first two DLs; drug target engagement, identified using the company's mass spectrometry-based AP3 profiling capabilities; and initial clinical activity in a DL3 patient, with significant decrease in size of metastatic lesions throughout the chest, abdomen and pelvis. This patient (who had received 3 prior lines of therapy including chemotherapy and anti-PD-1) remains on therapy. Using AP3-based Indication Finding and AP3-based analyses of in-house and publicly available data, the company is enrolling selected, high unmet need solid tumor types predicted sensitive to ACR-2316 in the clinical trial Anticipated Upcoming Milestones Provide update on registrational intent trial and confirmatory trial design for ACR-368 Report initial clinical data from the Phase 1 clinical study of ACR-2316 in the second half of 2025 Advance a new potential first-in-class cell cycle drug discovery program for an undisclosed target towards development candidate nomination in 2025 Fourth Quarter and Full Year 2024 Financial Results Net loss for the quarter and full year ended December 31, 2024 was $22.8 million and $80.6 million, respectively. This compares to a net loss of $19.3 million and $60.4 million, respectively for the same periods in 2023. Research and development expenses were $18.6 million for the quarter ended December 31, 2024, and $64.0 million for the full year 2024, compared to $15.5 million and $46.0 million, respectively, for the same periods in 2023. The difference was primarily due to the continued development of ACR-368 - which included the progression of the ongoing clinical trial and the achievement of milestones for the companion diagnostic, the initiation of the ACR-2316 clinical trial in the third quarter of 2024, and increased personnel to support development activities. General and administrative expenses were $6.3 million for the quarter ended December 31, 2024, and $25.2 million for the full year 2024, compared to $5.6 million and $21.1 million, respectively, for the same periods in 2023. The difference was primarily due to increased personnel costs, inclusive of non-cash stock compensation expense. As of December 31, 2024, the company had cash, cash equivalents and investments of $184.6 million, which is expected to fund operating expenses and capital expenditure requirements into 2027. About Acrivon Therapeutics Acrivon is a clinical stage biopharmaceutical company discovering and developing precision oncology medicines for patients whose tumors are predicted to be sensitive to each specific medicine by utilizing its proprietary Generative Phosphoproteomics 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 yielding terabytes of high resolution proprietary quantitative data for pathway-based drug design, indication finding, and response prediction. These distinctive capabilities enable AP3's direct application for streamlined rational drug discovery 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 (also known as prexasertib), a selective small molecule inhibitor targeting CHK1 and CHK2 in a potentially registrational Phase 2 trial, focusing on endometrial cancer. 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 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 designations for the ACR-368 OncoSignature assay for the identification of patients with endometrial cancer 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 pipeline programs. These include ACR-2316, the company's second clinical stage asset, a novel, potent, selective WEE1/PKMYT1 inhibitor designed for superior single-agent activity through strong activation of not only CDK1 and CDK2, but also of PLK1 to drive pro-apoptotic cell death, as demonstrated in preclinical studies against benchmark inhibitors. In addition, the company has a preclinical cell cycle program with an undisclosed target. Acrivon has developed its AP3 Interactome, a proprietary, computational analytics platform driven by Generative Phosphoproteomics machine learning for integrated comprehensive analyses across all large, in-house AP3 phosphoproteomic drug profiling data sets to advance its in-house research programs. 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, preclinical and clinical results, 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., Alexandra Santos asantos@ Acrivon Therapeutics, Inc. Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share data) Three Months Ended December 31, Year Ended December 31, 2024 2023 2024 2023 Operating expenses: Research and development $ 18,630 $ 15,478 $ 63,992 $ 46,024 General and administrative 6,324 5,575 25,207 21,079 Total operating expenses 24,954 21,053 89,199 67,103 Loss from operations (24,954 ) (21,053 ) (89,199 ) (67,103 ) Other income (expense), net: Interest income 2,363 1,692 9,201 7,037 Other income (expense), net (240 ) 109 (558 ) (322 ) Total other income, net 2,123 1,801 8,643 6,715 Net loss $ (22,831 ) $ (19,252 ) $ (80,556 ) $ (60,388 ) Net loss per share - basic and diluted $ (0.60 ) $ (0.86 ) $ (2.38 ) $ (2.74 ) Weighted-average common stock outstanding - basic and diluted 38,242,412 22,335,407 33,791,817 22,078,190 Comprehensive loss: Net loss $ (22,831 ) $ (19,252 ) $ (80,556 ) $ (60,388 ) Other comprehensive income (loss): Unrealized gain (loss) on available-for-sale investments, net of tax (335 ) 219 530 12 Comprehensive loss $ (23,166 ) $ (19,033 ) $ (80,026 ) $ (60,376 ) Acrivon Therapeutics, Consolidated Balance Sheets(in thousands) December 31, 2024 2023 Assets Cash and cash equivalents $ 39,818 $ 36,015 Investments 144,751 91,443 Other assets 12,019 10,807 Total assets $ 196,588 $ 138,265 Liabilities and Stockholders' Equity Liabilities 19,802 17,070 Stockholders' Equity 176,786 121,195 Total Liabilities and Stockholders' Equity $ 196,588 $ 138,265 Sign in to access your portfolio
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05-02-2025
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Acrivon Therapeutics Announces FDA has Granted Breakthrough Device Designation for ACR-368 OncoSignature Assay for Endometrial Cancer
The ACR-368-tailored OncoSignature assay is being used to predict patients most likely to respond to ACR-368 in Acrivon's ongoing, registrational-intent, multicenter Phase 2b trial of ACR-368 in patients with endometrial cancer and other tumor types Clinical data presented at ESMO 2024 demonstrates statistically significant segregation of patient responders in biomarker-positive versus biomarker-negative subgroups based on prospective OncoSignature patient selection (p-value = 0.009) Drug-tailored, proprietary OncoSignature biomarker assays are developed using the generative AI-driven Acrivon Predictive Precision Proteomics (AP3) platform, which is also used for streamlined, biologically rational drug design and indication finding WATERTOWN, Mass., Feb. 05, 2025 (GLOBE NEWSWIRE) -- Acrivon Therapeutics, Inc. ('Acrivon' or 'Acrivon Therapeutics') (Nasdaq: ACRV), a clinical stage precision medicine company utilizing its Acrivon Predictive Precision Proteomics (AP3) platform for the discovery, design, and development of drug candidates through a mechanistic match to patients whose disease is predicted sensitive to the specific treatment, announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for the ACR-368 OncoSignature assay, a multiplex immunofluorescence assay for the identification of endometrial cancer patients who may benefit from ACR-368 treatment. The designation reflects the FDA's determination that the device is reasonably expected to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions. 'We are pleased that the FDA has designated our ACR-368 OncoSignature assay, developed specifically to prospectively predict tumor sensitivity to ACR-368 and used in our advancing registrational-intent clinical study, as a Breakthrough Device for patients with endometrial cancer,' said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and founder of Acrivon Therapeutics. 'This is the second such designation for our ACR-368 OncoSignature assay and represents yet another powerful validation of our generative AI-driven AP3 platform. The enrollment and dosing continues for both ACR-368 in our ongoing Phase 2b trials, as well as for ACR-2316, our internally-developed Phase 1 asset, which is a novel, differentiated WEE1/PKMYT1 inhibitor uniquely enabled by AP3. We have now completed enrollment in the first two dose-escalation cohorts of the ACR-2316 Phase 1 trial and initiated dosing in the third cohort.' A company-sponsored, blinded, third-party KOL market research study showed strong interest in the emerging clinical profile of ACR-368. There is an estimated ~30,000 (and growing) new cases of high-grade, locally advanced or metastatic, recurrent (progressed on anti-PD-1 and chemotherapy) endometrial cancer per year in the U.S. The company presented positive clinical data at ESMO 2024 demonstrating a confirmed overall response rate (ORR) of 62.5% (95% CI, 30.4-86.5), as well as prospective ACR-368 OncoSignature patient selection (p = 0.009) in endometrial cancer. The Breakthrough Devices Program is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and marketing authorization. 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 generative AI-driven 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 yielding terabytes of high resolution proprietary quantitative data for pathway-based drug design, indication finding, and response prediction. These distinctive capabilities enable AP3's direct application for streamlined rational drug discovery 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 (also known as prexasertib), 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 designations for the ACR-368 OncoSignature assay for the identification of patients with endometrial cancer or for patients with ovarian cancer, who may benefit from ACR-368 treatment. The company reported positive clinical data for ovarian and endometrial cancers in April 2024, and in September 2024 it reported additional positive clinical data for endometrial cancer, including a confirmed overall response rate of 62.5% (95% CI, 30.4 - 86.5) and further validation of its prospective OncoSignature selection of patients predicted sensitive to ACR-368 by showing segregation of responders in OncoSignature-positive versus OncoSignature-negative patients (p = 0.009). The median duration of treatment was not yet reached, but the duration on study was 6 months at the time of the data cut. In addition to ACR-368, Acrivon is also leveraging its proprietary AP3 precision medicine platform for developing its co-crystallography-driven, internally-discovered pipeline programs. These include ACR-2316, the company's second clinical stage asset, a novel, potent, selective WEE1/PKMYT1 inhibitor designed for superior single-agent activity through strong activation of not only CDK1 and CDK2, but also of PLK1 to drive pro-apoptotic cell death, as demonstrated in preclinical studies against benchmark inhibitors. In addition, the company has a preclinical cell cycle program with an undisclosed target. Acrivon has developed AP3 Interactome, a proprietary, computational analytics platform driven by machine learning for integrated comprehensive analyses across all large, in-house AP3 phosphoproteomic drug profiling data sets to advance its in-house research programs. 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, preclinical and clinical results, 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., Alexandra Santos asantos@
