Acrivon Therapeutics Reports Third Quarter 2024 Financial Results and Business Highlights
Acrivon Therapeutics reported Q3 2024 financial results and business highlights. The company achieved a 62.5% confirmed overall response rate in their Phase 2b endometrial cancer study for ACR-368. The trial demonstrated statistical significance (p=0.009) in patient selection using their OncoSignature technology. The company completed enrollment for their first dose-escalation cohort in the Phase 1 study of ACR-2316. Financial position remains strong with $202.8 million in cash and equivalents, expected to fund operations into H2 2026. Q3 2024 net loss was $22.4 million, with R&D expenses of $18.9 million and G&A expenses of $6.3 million.
Acrivon Therapeutics ha riportato i risultati finanziari e i punti salienti commerciali del terzo trimestre del 2024. L'azienda ha ottenuto un 62,5% di tasso di risposta complessivo confermato nel loro studio di fase 2b sul cancro endometriale per ACR-368. La sperimentazione ha dimostrato una significatività statistica (p=0.009) nella selezione dei pazienti utilizzando la loro tecnologia OncoSignature. L'azienda ha completato l'arruolamento per il primo gruppo di dose crescente nello studio di fase 1 di ACR-2316. La posizione finanziaria rimane forte con 202,8 milioni di dollari in contante e equivalenti, previsti per finanziare le operazioni fino alla seconda metà del 2026. La perdita netta del terzo trimestre del 2024 è stata di 22,4 milioni di dollari, con spese per ricerca e sviluppo di 18,9 milioni di dollari e spese generali e amministrative di 6,3 milioni di dollari.
Acrivon Therapeutics reportó los resultados financieros y los puntos destacados del negocio del tercer trimestre de 2024. La compañía logró una tasa de respuesta general confirmada del 62,5% en su estudio de cáncer endometrial de fase 2b para ACR-368. El ensayo demostró significancia estadística (p=0.009) en la selección de pacientes utilizando su tecnología OncoSignature. La compañía completó la inscripción para su primer cohorte de escalada de dosis en el estudio de fase 1 de ACR-2316. La posición financiera sigue siendo sólida con 202,8 millones de dólares en efectivo y equivalentes, que se espera financien las operaciones hasta la segunda mitad de 2026. La pérdida neta del tercer trimestre de 2024 fue de 22,4 millones de dólares, con gastos de I+D de 18,9 millones de dólares y gastos de administración y generales de 6,3 millones de dólares.
Acrivon Therapeutics는 2024년 3분기 재무 결과 및 사업 하이라이트를 발표했습니다. 회사는 ACR-368에 대한 2b상 자궁내막암 연구에서 62.5%의 확인된 전체 반응률을 달성했습니다. 이 시험은 OncoSignature 기술을 사용한 환자 선택의 통계적 유의성(p=0.009)을 보여주었습니다. 회사는 ACR-2316의 1상 연구에서 첫 번째 용량 조절 코호트에 대한 등록을 완료했습니다. 재무 상태는 여전히 강력하며 2억 280만 달러의 현금 및 현금성 자산을 보유하고 있어 2026년 하반기까지 운영 자금을 지원할 것으로 예상됩니다. 2024년 3분기 순손실은 2240만 달러였으며, 연구개발비는 1890만 달러, 일반관리비는 630만 달러였습니다.
Acrivon Therapeutics a publié les résultats financiers et les points saillants de l'activité pour le troisième trimestre de 2024. La société a atteint un taux de réponse global confirmé de 62,5% dans son étude de phase 2b sur le cancer de l'endomètre pour ACR-368. L'essai a montré une signification statistique (p=0.009) dans la sélection des patients utilisant leur technologie OncoSignature. La société a également complété l'inscription pour son premier cohorte d'escalade de dose dans l'étude de phase 1 sur ACR-2316. La position financière reste solide avec 202,8 millions de dollars en liquidités et équivalents, prévu pour financer les opérations jusqu'au second semestre 2026. La perte nette pour le troisième trimestre 2024 s'élevait à 22,4 millions de dollars, avec des dépenses en R&D de 18,9 millions de dollars et des dépenses générales et administratives de 6,3 millions de dollars.
Acrivon Therapeutics hat die finanziellen Ergebnisse und Geschäftshighlights für das dritte Quartal 2024 veröffentlicht. Das Unternehmen erzielte eine bestätigte Gesamtansprechrate von 62,5% in seiner Phase-2b-Studie zu Endometriumkrebs mit ACR-368. Die Studie zeigte eine statistische Signifikanz (p=0,009) bei der Patientenauswahl mithilfe ihrer OncoSignature-Technologie. Das Unternehmen hat die Einschreibung für seine erste Dosiseskalationskohorte in der Phase-1-Studie von ACR-2316 abgeschlossen. Die finanzielle Lage bleibt stark mit 202,8 Millionen Dollar in liquiden Mitteln und Äquivalenten, die voraussichtlich die Betriebe bis zur zweiten Hälfte von 2026 finanzieren werden. Der Nettverlust im dritten Quartal 2024 betrug 22,4 Millionen Dollar, bei Forschungs- und Entwicklungsausgaben von 18,9 Millionen Dollar und allgemeinen Verwaltungskosten von 6,3 Millionen Dollar.
- 62.5% confirmed overall response rate in Phase 2b endometrial cancer trial
- Strong cash position of $202.8M, funding operations into H2 2026
- Statistically significant patient selection validation (p=0.009)
- Early completion of first dose-escalation cohort enrollment for ACR-2316
- Increased net loss to $22.4M in Q3 2024 from $14.5M in Q3 2023
- R&D expenses increased to $18.9M from $10.3M year-over-year
- G&A expenses rose to $6.3M from $5.9M year-over-year
Insights
The clinical data for ACR-368 shows remarkable promise in endometrial cancer treatment, with a
The market opportunity is substantial with 30,000 annual new cases of high-grade endometrial cancer in the U.S. and
The company's strong financial position with
The market opportunity in second-line endometrial cancer treatment represents a significant commercial potential, especially given the recent front-line therapy changes that have created a treatment gap in second-line options.
– Positive clinical data with confirmed overall response rate (ORR) =
– Endometrial cancer, a tumor type identified by AP3 as particularly sensitive to ACR-368 treatment, represents the first potential approval opportunity for ACR-368, in second line, with options to move into the front-line setting being evaluated
– Completed planned enrollment of first dose-escalation cohort in ongoing Phase 1 study of ACR-2316, company’s second clinical stage asset, internally discovered using AP3
– Cash, cash equivalents and marketable securities of
WATERTOWN, Mass, Nov. 13, 2024 (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 third quarter ended September 30, 2024 and reviewed recent business highlights.
“Our team continues to deliver impressive progress advancing a pipeline of differentiated clinical stage therapies,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and founder of Acrivon. “During the third quarter, we shared promising data from our Phase 2b study of ACR-368, demonstrating a confirmed
Recent Highlights
- Presented positive interim endometrial cancer data at the European Society for Medical Oncology congress (ESMO) and at a subsequent corporate event, from the ongoing, registrational-intent, multicenter Phase 2b trial of ACR-368 in patients with endometrial adenocarcinoma who had progressed on prior anti-PD-1 therapy, unless ineligible. Endometrial cancer had not been previously studied in prior ACR-368 trials sponsored by Eli Lilly and Company. Using AP3 for indication screening, this tumor type was predicted to be particularly sensitive to ACR-368 prior to the current ongoing Phase 2b study. The data were based on 35 safety-evaluable patients, of which 23 (8 OncoSignature-positive (BM+) and 15 OncoSignature-negative (BM-) patients) were efficacy-evaluable with at least one on-treatment scan (data cut-off July 25, 2024).
- Confirmed ORR, per RECIST 1.1, of
62.5% (95% CI, 30.4-86.5) was observed in the cohort of prospectively-selected BM+ patients who were efficacy-evaluable- Median duration of response (mDOR) was not yet reached at the time of data cut-off (~6 months)
- All confirmed responders had progressed on prior chemo and anti-PD-1 therapy and best overall response (BOR) in last prior line was predominantly progressive disease (PD) in the confirmed ACR-368 responders
- Consistent with the ACR-368 OncoSignature prediction being independent of genetic alterations and tissue type, confirmed responses were observed across molecular and histological subtypes
- Achieved statistically significant segregation of responders in BM+ versus BM- subgroups based on prospective OncoSignature patient selection (p-value = 0.009)
- Consistent with past trials and earlier reported data from this trial, the ACR-368 treatment-related adverse events (AEs) observed were limited, predominantly transient, reversible, mechanism-based hematological AEs, which typically occurred during the first 1-2 cycles of therapy. There was a notable absence of long-lasting myelosuppression, or the typical more severe non-hematological AEs commonly seen with antibody drug conjugates and chemotherapy.
- Confirmed ORR, per RECIST 1.1, of
- Provided a summary of company-conducted, blinded third-party KOL market research which showed strong interest in the emerging clinical profile of ACR-368 (product name blinded) as an important potential therapy in the rapidly evolving treatment landscape of high-grade, recurrent endometrial cancer where second-line options are now limited due to the recent approval of anti-PD-1 and chemotherapy as front-line therapy
- An estimated ~30K 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.
- ~
90% of these patients will progress to second line - The recent approval of pembrolizumab plus chemotherapy as a front-line treatment leaves a significant unmet need in the second line, where the bar based on reported chemotherapy efficacy in the second line is an ORR of
14.7% and median progress-free survival of 3.8 months (Makker et al; N Engl J Medicine, 2022), which potentially overestimates the current ORR for chemotherapy in the second line, given this was based on patients that had only received prior chemotherapy, but not prior anti-PD-1 - The company’s ongoing single-arm, registrational-intent Phase 2b monotherapy trial in endometrial cancer represents the first potential accelerated approval opportunity for ACR-368
- The company is evaluating options to potentially move into the front-line setting as part of its confirmatory trial strategy
- Began dosing patients, two quarters ahead of original timelines, in the Phase 1 monotherapy clinical trial of ACR-2316, a potent, selective WEE1/PKMYT1 inhibitor designed by AP3 to overcome the limitations of single-target WEE1 and PKMYT1 inhibitors
- ACR-2316 was internally discovered and advanced in 15 months from initial lead to Phase 1 trial initiation, which was uniquely enabled by AP3
- The Phase 1 study will assess the safety and tolerability of ACR-2316. Additionally, the study will seek to establish the pharmacokinetic profile, evaluate preliminary anti-tumor activity and determine the recommended Phase 2 monotherapy dose. Dose optimization will be guided by drug target engagement in alignment with the Food and Drug Administration’s Project Optimus. AP3-based indication finding and OncoSignature development is ongoing.
- Completed planned enrollment of the first patient cohort of the dose-escalation portion of the Phase 1 trial
- Presented multiple datasets demonstrating the deployment of the company’s AP3 platform for streamlined, machine learning-driven drug discovery and clinical development at two scientific conferences - Human Proteome Organization World Congress and EORTC-NCI-AACR Symposium
- AP3-identified clinical biomarkers for ACR-368 led to the development of the response-predictive ACR-368 OncoSignature assay which has shown statistically significant prospective validation and responder enrichment in the ongoing registrational-intent Phase 2b study
- ACR-2316 was uniquely enabled and optimized by AP3 to deliver superior single-agent activity, complete tumor regression and pro-apoptotic tumor cell death through potent activation of CDK1, CDK2, and PLK1
Anticipated Upcoming Milestones
- Provide program updates from our ongoing registrational-intent Phase 2b trial of ACR-368 in patients with gynecological cancers prospectively predicted sensitive to ACR-368 in the first half of 2025
- Report initial data from the Phase 1 clinical study of ACR-2316, which is enriched for tumor types predicted to be sensitive to monotherapy through AP3-based indication finding, 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
Third Quarter 2024 Financial Results
Net loss for the quarter ended September 30, 2024 was
Research and development expenses were
General and administrative expenses were
As of September 30, 2024, the company had cash, cash equivalents and marketable securities of
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 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. These distinctive capabilities enable AP3’s direct application for drug design optimization 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 registrational-intent Phase 2b 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 designation for the ACR-368 OncoSignature assay for the identification of ovarian cancer patients 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
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., M.B.A.
alevy@acrivon.com
Alexandra Santos
asantos@wheelhouselsa.com
| Acrivon Therapeutics, Inc. Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited, in thousands, except share and per share data) | ||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 18,864 | $ | 10,267 | $ | 45,362 | $ | 30,546 | ||||||||
| General and administrative | 6,276 | 5,870 | 18,883 | 15,504 | ||||||||||||
| Total operating expenses | 25,140 | 16,137 | 64,245 | 46,050 | ||||||||||||
| Loss from operations | (25,140 | ) | (16,137 | ) | (64,245 | ) | (46,050 | ) | ||||||||
| Other income (expense), net: | ||||||||||||||||
| Interest income | 2,698 | 1,768 | 6,838 | 5,345 | ||||||||||||
| Other income (expense), net | 1 | (97 | ) | (318 | ) | (431 | ) | |||||||||
| Total other income, net | 2,699 | 1,671 | 6,520 | 4,914 | ||||||||||||
| Net loss | $ | (22,441 | ) | $ | (14,466 | ) | $ | (57,725 | ) | $ | (41,136 | ) | ||||
| Net loss per share - basic and diluted | $ | (0.59 | ) | $ | (0.66 | ) | $ | (1.79 | ) | $ | (1.87 | ) | ||||
| Weighted-average common stock outstanding - basic and diluted | 38,105,131 | 22,081,162 | 32,297,457 | 21,991,509 | ||||||||||||
| Comprehensive loss: | ||||||||||||||||
| Net loss | $ | (22,441 | ) | $ | (14,466 | ) | $ | (57,725 | ) | $ | (41,136 | ) | ||||
| Other comprehensive income (loss): | ||||||||||||||||
| Unrealized gain (loss) on available-for-sale investments, net of tax | 801 | 125 | 865 | (207 | ) | |||||||||||
| Comprehensive loss | $ | (21,640 | ) | $ | (14,341 | ) | $ | (56,860 | ) | $ | (41,343 | ) | ||||
| Acrivon Therapeutics, Inc. Condensed Consolidated Balance Sheets (unaudited, in thousands) | ||||||||
| September 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Assets | ||||||||
| Cash and cash equivalents | $ | 43,415 | $ | 36,015 | ||||
| Investments | 159,428 | 91,443 | ||||||
| Other assets | 11,841 | 10,807 | ||||||
| Total assets | $ | 214,684 | $ | 138,265 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Liabilities | 17,792 | 17,070 | ||||||
| Stockholders' Equity | 196,892 | 121,195 | ||||||
| Total Liabilities and Stockholders' Equity | $ | 214,684 | $ | 138,265 | ||||
FAQ
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