Latest news with #MSSCRC
Business Insider
4 days ago
- Business
- Business Insider
Xilio Therapeutics announces updated Phase 2 data for vilastobart
Xilio Therapeutics (XLO) announced updated data from its ongoing Phase 2 clinical trial evaluating vilastobart, a tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4, in combination with atezolizumab in patients with metastatic MSS CRC. The data will be presented in a poster session at the American Society of Clinical Oncology, ASCO, Annual Meeting in Chicago. Results include: 26% preliminary objective response rate observed in heavily pre-treated patients with metastatic microsatellite stable colorectal cancer without liver metastases; Deep and durable responses ongoing for up to 37 weeks through the data cutoff, accompanied by substantial decreases in tumor biomarkers and improvements in clinical symptoms; MSS CRC patient with liver metastasis and previously reported confirmed partial response from Phase 1C remains on treatment after more than 14 months; combination continued to demonstrate differentiated safety and tolerability profile with low incidence of colitis and other immune-related adverse events Confident Investing Starts Here:
Yahoo
5 days ago
- Business
- Yahoo
Xilio Therapeutics Announces Updated Phase 2 Data for Vilastobart, a Tumor-Activated Anti-CTLA-4, in Combination with Atezolizumab in Patients with Metastatic Microsatellite Stable Colorectal Cancer
26% preliminary objective response rate observed in heavily pre-treated patients with metastatic microsatellite stable colorectal cancer (MSS CRC) without liver metastases Deep and durable responses ongoing for up to 37 weeks through the data cutoff, accompanied by substantial decreases in tumor biomarkers and improvements in clinical symptoms MSS CRC patient with liver metastasis and previously reported confirmed partial response from Phase 1C (combination dose escalation) remains on treatment after more than 14 months Combination continued to demonstrate differentiated safety and tolerability profile with low incidence of colitis and other immune-related adverse events Data are being presented in a poster presentation today at the 2025 ASCO Annual Meeting WALTHAM, Mass., May 31, 2025 (GLOBE NEWSWIRE) -- Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with cancer, today announced updated data from its ongoing Phase 2 clinical trial evaluating vilastobart, a tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4, in combination with atezolizumab (Tecentriq®) in patients with metastatic MSS CRC. The data will be presented in a poster session (abstract #3553) today at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. 'These Phase 2 data for the combination of vilastobart and atezolizumab demonstrate a meaningfully differentiated safety and tolerability profile for an anti-CTLA-4 combination therapy, together with a preliminary 26% objective response rate in patients with late-line metastatic MSS CRC without liver metastases,' said Katarina Luptakova, M.D., chief medical officer of Xilio. 'Responses were deep and durable for up to 37 weeks and were accompanied by substantial decreases in tumor biomarkers such as circulating tumor DNA and improvements in clinical symptoms. Currently, no immunotherapy treatment options are available for patients with MSS CRC, an immunologically cold tumor type that is rising in incidence. We are very encouraged by these data demonstrating the potential of vilastobart, a next generation anti-CTLA-4, as a combination therapy not only for patients with MSS CRC but also a range of other tumor types traditionally resistant to treatment with immunotherapy.' 'These data further highlight the potential for vilastobart, a tumor-activated anti-CTLA-4, in combination with PD-(L)1 inhibitors to provide a meaningful clinical benefit for patients with metastatic MSS CRC without liver metastases, an area of significant and increasing unmet need, especially in younger people,' said Marwan G. Fakih, M.D., Professor in the Department of Medical Oncology and Therapeutics Research and Division Head, GI Medical Oncology at City of Hope. 'I am particularly excited to see the depth and durability of responses in these late-line patients, as well as the low incidence of colitis and other immune-related adverse events that are common dose-limiting adverse events for other anti-CTLA-4 agents. Beyond MSS CRC, I believe these data support the potential for vilastobart as a combination therapy across a range of tumor types, including those where toxicity has limited the significant opportunity for anti-CTLA-4 to date.' Updated Data from Phase 2 Trial for Vilastobart, a Tumor-Activated Anti-CTLA-4, in Combination with Atezolizumab in Patients with Metastatic MSS CRC As of a data cutoff date of May 12, 2025, 44 patients with metastatic MSS CRC had been treated with the combination of vilastobart at 100 mg once every six weeks (Q6W) and atezolizumab at 1200 mg once every three weeks (Q3W). The median age was 55 years (ranging from 25 to 82 years), and patients were heavily pre-treated, with 80% having previously received three or more prior lines of anti-cancer therapy. As of the data cutoff date, 44 patients were evaluated for response (per RECIST version 1.1 criteria), consisting of 27 patients without liver metastases and 17 patients with liver metastases. In patients with metastatic MSS CRC without liver metastases: Investigators reported a preliminary ORR of 26% consisting of seven PRs (six confirmed, including two confirmed after the data cutoff, and one unconfirmed), with six of these patients still on treatment as of the data cutoff date. Responders included a patient with peritoneal metastases as well as patients with both KRAS mutant and KRAS wild type tumors. In addition, investigators reported stable disease in five patients without liver metastases, with three of these patients remaining on treatment as of the data cutoff date. Responses were deep and durable, with reductions in target lesions of up to 71% from baseline and responders ongoing on treatment for up to 37 weeks as of the data cutoff date. Responses were accompanied by substantial decreases in tumor biomarkers for circulating tumor DNA (ctDNA) and carcinoembryonic antigen (CEA) levels. In addition, investigators observed improvements in clinical symptoms. In patients with metastatic MSS CRC with liver metastases, investigators reported stable disease in three patients, each of whom was still on treatment as of the data cutoff date. As of the data cutoff date, 44 patients were evaluable for safety. Across all patients treated, the combination of vilastobart at 100 mg Q6W and atezolizumab at 1200 mg Q3W was generally well-tolerated: Only three patients (7%) experienced colitis (one patient with Grade 1 colitis and two patients with Grade 3 colitis). In addition, only 11 patients (25%) required steroids or other immunosuppression for imAEs. Only two patients (5%) discontinued treatment for the combination of vilastobart and atezolizumab due to a treatment-related adverse event (AE). The most common treatment-related AEs (≥10% incidence) of any grade reported by investigators were fatigue (30%); infusion-related reactions (23%); diarrhea (18%); aspartate aminotransferase (AST) increase (14%); alanine aminotransferase (ALT) increase (11%); pruritus (11%); and pyrexia (11%). The only Grade 3 treatment-related AEs reported by investigators in more than one patient were the following (2 patients each (5%)): colitis; AST increase; ALT increase; infusion-related reactions; and white blood cell decrease. As previously reported, there were no Grade 5 treatment-related AEs and investigators reported only two Grade 4 treatment-related AEs (laboratory abnormalities of thrombocytopenia and neutropenia, one patient each) both of which resolved. Phase 1C (Combination Dose Escalation) Updates In the ongoing Phase 1C, the 150 mg Q6W dose level was recently cleared for vilastobart, and evaluation of patients enrolled in Phase 1C is ongoing. In addition, as previously reported, an MSS CRC patient with a metastatic liver lesion enrolled in Phase 1C achieved a confirmed partial response, including full resolution of the liver lesion. As of the data cutoff date, this patient was still on treatment after more than 14 months. Clinical Development Plans for Vilastobart In the ongoing Phase 2 trial, Xilio recently began enrolling a cohort of patients with metastatic MSS CRC at the 150 mg Q6W dose level for vilastobart. Xilio anticipates initially enrolling approximately 10 patients with metastatic MSS CRC without liver metastases in the Phase 2 trial at the 150 mg Q6W dose level for vilastobart, with the goal of further evaluating the efficacy and safety of the combination at this higher dose level. Xilio anticipates reporting additional data from the Phase 2 trial in the first half of 2026, including data for patients at the 150 mg Q6W dose level for vilastobart. Based on the encouraging Phase 1/2 data for vilastobart in patients with metastatic MSS CRC, Xilio is seeking opportunities to partner the vilastobart program to accelerate and expand further development. About Vilastobart and the Phase 1/2 Combination Clinical Trial Vilastobart is an investigational tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4 monoclonal antibody designed to block CTLA-4 and deplete regulatory T cells when activated in the tumor microenvironment (TME). In 2023, Xilio entered into a co-funded clinical trial collaboration with Roche to evaluate vilastobart in combination with atezolizumab (Tecentriq®) in a multi-center, open-label Phase 1/2 clinical trial. Xilio is currently evaluating the safety of the combination in Phase 1C dose escalation in patients with advanced solid tumors and the efficacy and safety of the combination in Phase 2 in patients with metastatic microsatellite stable colorectal cancer (MSS CRC) with and without liver metastases. Please refer to NCT04896697 on for additional details. About Xilio Therapeutics Xilio Therapeutics is a clinical-stage biotechnology company discovering and developing tumor-activated, or masked, immuno-oncology (I-O) therapies with the goal of significantly improving outcomes for people living with cancer without the systemic side effects of current I-O treatments. The company is leveraging its proprietary platform to advance a pipeline of novel, tumor-activated I-O molecules that are designed to optimize the therapeutic index by localizing anti-tumor activity within the tumor microenvironment. Learn more by visiting and follow us on LinkedIn (Xilio Therapeutics, Inc.). Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the potential for vilastobart to provide benefit as a combination therapy in any indication or at any dose level; the development plans for vilastobart and the timing thereof; the timing of clinical data for vilastobart; the ultimate efficacy and safety profile of vilastobart; the ability to partner the vilastobart program; and Xilio's strategy, goals and anticipated financial performance, milestones, business plans and focus. The words 'aim,' 'may,' 'will,' 'could,' 'would,' 'should,' 'expect,' 'plan,' 'anticipate,' 'intend,' 'believe,' 'estimate,' 'predict,' 'project,' 'potential,' 'continue,' 'seek,' 'target' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of important risks, uncertainties and other factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks related to general market conditions and geopolitical uncertainties; risks and uncertainties related to ongoing and planned research and development activities, including initiating, conducting or completing preclinical studies and clinical trials and the timing and results of such preclinical studies or clinical trials; the delay of any current or planned preclinical studies or clinical trials or the development of Xilio's current or future product candidates; Xilio's ability to obtain and maintain sufficient preclinical and clinical supply of current or future product candidates; Xilio's ability to advance multiple early stage masked T cell engager programs; initial, preliminary or interim preclinical or clinical data or results may not be replicated in or predictive of future preclinical or clinical data or results; Xilio's ability to successfully demonstrate the safety and efficacy of its product candidates and gain approval of its product candidates on a timely basis, if at all; results from preclinical studies or clinical trials for Xilio's product candidates may not support further development of such product candidates; actions of regulatory agencies may affect the initiation, timing and progress of current or future clinical trials; Xilio's ability to obtain, maintain and enforce patent and other intellectual property protection for current or future product candidates; Xilio's need to obtain additional cash resources to fund its operations beyond the first quarter of 2026, including to advance its pipeline of tumor-activated I-O molecules; the impact of international trade policies on Xilio's business, including U.S. and China trade policies; and Xilio's ability to maintain its collaboration or partnership agreements with AbbVie, Gilead and Roche. These and other risks and uncertainties are described in greater detail in the sections entitled 'Risk Factor Summary' and 'Risk Factors' in Xilio's filings with the U.S. Securities and Exchange Commission ('SEC'), including Xilio's most recent Quarterly Report on Form 10-Q and any other filings that Xilio has made or may make with the SEC in the future. Any forward-looking statements contained in this press release represent Xilio's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, Xilio explicitly disclaims any obligation to update any forward-looking statements. This press release contains hyperlinks to information that is not deemed to be incorporated by reference in this press release. Tecentriq® is a registered trademark of Genentech USA, Inc., a member of the Roche Group. Investor and Media Contact Scott Young Vice President, Investor Relations and Corporate Communications investors@ in to access your portfolio
Yahoo
21-05-2025
- Business
- Yahoo
Marengo Appoints Dr. Everett Vokes to the Scientific Advisory Board While Advancing Invikafusp alfa Clinical Program in PD-1 Resistant Solid Tumors
Appointment supports continued momentum of the company's rapidly accelerating precision oncology development strategy CAMBRIDGE, Mass., May 21, 2025 /PRNewswire/ -- Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering novel approaches to precision T cell activation, today announced the appointment of Everett E. Vokes, M.D., to its Scientific Advisory Board (SAB). This appointment marks the latest expansion of Marengo's industry-leading SAB, comprised of world-class experts in clinical and translational oncology and immunology. With more than 40 years of clinical and translational research experience, Dr. Vokes is internationally recognized for his expertise in the treatment of head and neck and lung cancers. He is the John E. Ultmann Distinguished Service Professor of Medicine, Professor of Radiation and Cellular Oncology, and Chair of the Department of Medicine at the University of Chicago. Dr. Vokes currently serves as Physician-in-Chief for the UChicago Medicine health system, and served as the 2021-2022 President of the American Society of Clinical Oncology (ASCO). "We are honored to welcome Dr. Vokes to our esteemed team of scientific advisors guiding the development of Marengo's innovative oncology pipeline," said Zhen Su, M.D., M.B.A., Chief Executive Officer of Marengo Therapeutics. "Following our recent data presented at AACR showing pan-tumor activity of Invikafusp alfa in multiple solid tumors that are resistant to PD-1 treatment, Dr. Vokes' deep expertise and leadership in the landscape of clinical cancer research, specifically in thoracic oncology, will be instrumental in shaping our development strategy. His insight will not only help advance invikafusp as a next generation pan-tumor IO backbone but will also provide broader guidance as we progress our expanding pipeline." A long-standing leader in cooperative group research, Dr. Vokes chaired the CALGB (now part of the Alliance) Respiratory Committee and has served as principal investigator on numerous NCI-funded trials. He is the recipient of numerous honors, including the Translational Research Professorship from ASCO and the "Giant of Cancer Care" award in 2013. Dr. Vokes has published more than 450 scientific papers and 80 book chapters and has served on editorial boards for leading oncology journals including Journal of Clinical Oncology, Annals of Oncology, and Clinical Lung Cancer. "Marengo's approach to precision T cell activation represents a key scientific advancement with broad implications across different solid tumors that are treatment resistant to PD-1," Dr. Vokes said. "The early signs of activity in MSS CRC and PD-1 negative NSCLC – the populations historically resistant to immune checkpoint blockade — suggest a novel mechanism of action with the potential to overcome PD-1 resistance, which remains a very high unmet medical need. I'm honored to join this distinguished group of advisors and contribute to the clinical development of Marengo's pipeline as the team works to expand the impact of immunotherapy across difficult-to-treat cancers." About Marengo Therapeuticseve Marengo Therapeutics, Inc. is a clinical-stage biotechnology company developing a first-in-class pipeline of novel TCR-targeting antibodies designed to selectively modulate disease-driving and protective T cell subsets. With its proprietary STAR™, TriSTAR™, and MSTAR™ platforms, Marengo is advancing precision immunotherapies that harness the body's T cell repertoire to provide durable responses against cancer and autoimmune diseases. Learn more at Media Contact:Peg Rusconi | Investor Contact:Svetlana Makhni | smakhni@ View original content to download multimedia: SOURCE Marengo Therapeutics 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
Associated Press
24-03-2025
- Business
- Associated Press
Adagene Reports Full Year 2024 Financial Results and Provides Corporate Update
Muzastotug Phase 2 dose expansion in MSS CRC with a 20 mg/kg loading dose regimen shows 33% overall response rate with four confirmed partial responses SAFEbody technology utilized to create masked T cell engagers for potentially superior safety profile with enhanced therapeutic index Cash balance of $85.2 million provides runway into late 2026 SAN DIEGO and SUZHOU, China, March 24, 2025 (GLOBE NEWSWIRE) -- Adagene Inc. ('Adagene') (Nasdaq: ADAG), a platform-driven, clinical-stage biotechnology company transforming the discovery and development of novel anti-body-based therapies, today reported financial results for the full year 2024 and provided corporate updates. 'The clinical data we generated in 2024 with ADG126 gives us great confidence in our ability to provide patients with colorectal cancer a tolerable, efficacious treatment option. These data also provide the basis for us to expand our study in microsatellite stable colorectal cancer (MSS CRC) to include earlier lines of therapy and patients with liver metastases, a patient subpopulation that has historically seen little to no benefit from checkpoint inhibitors,' said Peter Luo, Ph.D., Chairman, CEO and President of R&D at Adagene. 'Regulatory T cells, a primary mechanism of resistance, can be overcome through higher and more frequent dosing of a conditionally active anti-CTLA-4 antibody. We continue to believe that anti-CTLA-4 therapy can transform immunotherapy in combination with anti-PD-1 and other therapies. Our SAFEbody masking capability enables the best therapeutic index among all CTLA-4 programs, showing the potential to unlock therapeutic value with a target previously limited by safety concerns.' Dr. Luo continued, 'In addition to ADG126, we have also utilized our SAFEbody masking technology to create T cell engagers (TCEs) that can link T cells to any number of antigens presented on tumor cells. These masked TCEs can recruit the immune system for conditional cytotoxicity, shrinking tumors and prolonging patient survival. The combination of TCEs with ADG126, which depletes CTLA-4 mediated regulatory T cells, is expected to enhance the response to TCE therapy. We look forward to sharing more on our TCE programs going forward.' PIPELINE HIGHLIGHTS ADG126 - Phase 1b/2 data: 20 mg/kg loading dose followed by 10 mg/kg Q3W in combination with pembrolizumab, Merck's (known as MSD outside of the US and Canada) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), cohort achieved an improved ORR of 33%. All responders remain on treatment at a maintenance dose of 10 mg/kg Q3W or 10 mg/kg Q6W in combination with pembrolizumab Good tolerability with a manageable safety profile for ADG126 + pembrolizumab combo, with overall low discontinuation rate (6%) for the MSS CRC expansion cohort. No Grade 4/5 safety events were seen to date. Based on robust safety data of ADG126 at 20 mg/kg Q6W in combination with pembrolizumab, the efficacy of this dosing regimen is being evaluated in the cohort expansion stage of the Phase 1b/2 trial. Company also plans to evaluate a broader patient population, including patients with liver metastases, by combining with standard of care medicines, a combination that has been limited by safety concerns in the past. Investigator initiated Phase 2 trial of ADG126 in neoadjuvant colorectal cancer to begin enrolling patients in April at the National University Cancer Institute in Singapore ADG138, a SAFEbody engineered T cell engager targeting HER2, has shown a wide therapeutic window and extended half-life for prolonged circulation in the tumor micro-environment in preclinical models. ADG138 is currently IND-ready. ADG152, a SAFEbody engineered T cell engager targeting CD20, is designed to conditionally bind to CD20 on tumor cells and show negligible interaction with healthy cells, yielding a 100-fold reduction in cytokine release syndrome in preclinical models. ADG152 is currently in the IND-enabling phase. The Company is pursuing strategic partnerships to advance the SAFEbody T cell engager programs. ONGOING COLLABORATIONS Exelixis: In June 2023, Adagene received a US$3.0 million milestone payment from Exelixis for the successful nomination of lead SAFEbody candidates for the second collaboration program under a technology licensing agreement to develop novel masked antibody-drug conjugate candidates. Including upfront and other milestone payments, we have received over US$18 million in total from Exelixis to date. Sanofi: Adagene and Sanofi are collaborating to develop both bispecific and monoclonal SAFEbody antibody candidates, preparing preclinical candidates using Adagene's SAFEbody precision masking technology for future development and commercialization by Sanofi. The collaboration announced in March 2022 included an upfront payment of US$17.5 million for the initial two programs, an option fee for two additional programs, potential milestone payments of up to US$2.5 billion, and tiered royalties. Roche: Roche is sponsoring and conducting a phase 1b/2 multi-national trial to evaluate ADG126 in a triple combination with atezolizumab and bevacizumab in first-line hepatocellular carcinoma (HCC). To date, the combination has been well tolerated. Adagene retains global development and commercialization rights to ADG126. 2025 MILESTONES & CASH RUNWAY Consistent with ongoing initiatives to prudently manage its cash balance, Adagene expects its current cash balance to fund activities into late 2026, with the following milestones expected in 2025: Provide longer-term time-to-event data from the existing Ph 1b/2 study of ADG126 + pembrolizumab in 3L+ MSS CRC Update 20 mg/kg loading dose cohort for durability of response (DOR and other time-to-event endpoints) Conduct EOP1 meeting with FDA by Q3 to obtain their endorsement on the proposed dose regimens, trial design and patient population Initiate evaluation of ADG126 + pembrolizumab in combination with standard of care in MSS CRC patients including those with liver metastases, beginning Q2 Provide initial clinical data from investigator initiated Phase 2 trial for neoadjuvant ADG126 in colorectal cancer Establish additional collaboration/licensing agreements CORPORATE UPDATES JC Xu, M.D., Ph.D., Adagene's Chief Strategy Officer and Head of Regulatory Affairs, has recently transitioned from a full-time employee of Adagene to a consulting role. JC will continue to support the Company's development while serving as a consultant. Ms. Yumeng Wang, a member of Adagene's Board of Directors and a Vice President at General Atlantic, will step down from the Board upon filing of the Company's 2024 Annual Report on form 20-F due to personal reason. Ms. Wang has served on Adagene's Board since 2023 and provided invaluable guidance as Adagene has developed ADG126 through first-in-human clinical trials. Mervyn Turner, Ph.D., Independent Director of Adagene's Board of Directors, will complete his term as Independent Director concurrent with the filing of the Company's 2024 Annual Report on form 20-F, and transition to an advisory role. Mr. Turner has served on Adagene's Board of Directors since April of 2023 and will continue to provide strategic guidance to the Company in this advisory capacity. FINANCIAL HIGHLIGHTS Cash and Cash Equivalents: Cash and cash equivalents were US$85.2 million as of December 31, 2024, compared to US$109.9 million as of December 31, 2023. Total borrowings from commercial banks in China (denominated in RMB) decreased to US$18.2 million as of December 31, 2024 from US$21.9 million as of December 31, 2023. The associated loan proceeds were primarily used to support the company's R&D activities. Net Revenue: Net revenue was US$0.1 million for the year ended December 31, 2024, compared to US$18.1 million in 2023. Research and Development (R&D) Expenses: R&D expenses were US$28.8 million for the year ended December 31, 2024, compared to US$36.6 million in 2023. The decrease of approximately 21% in R&D expenses reflects clinical focus on and prioritization of the company's masked, anti-CTLA-4 SAFEbody ADG126. Administrative Expenses: Administrative expenses were US$7.3 million for the year ended December 31, 2024, compared to US$8.7 million in 2023. The decrease was due to both a reduction in personnel and in office-related expenses as a result of cost-control measures. Other Operating Income, Net: Other operating income, net was nil for the year ended December 31, 2024 compared to US$3.5 million in 2023. The amount of US$3.5 million included a one-time compensation payment from a contract manufacturer for a preclinical-related outsourcing arrangement. Net Loss: Net loss attributable to Adagene Inc.'s shareholders was US$33.4 million for the year ended December 31, 2024, compared to US$18.9 million in 2023. Ordinary Shares Outstanding: As of December 31, 2024, there were 58,886,944 ordinary shares issued and outstanding. Each American depository share, or ADS, represents one and one quarter (1.25) ordinary shares of the company. Non-GAAP Net Loss: Non-GAAP net loss, which is defined as net loss attributable to ordinary shareholders for the period after excluding share-based compensation expenses, was US$28.5 million for the year ended December 31, 2024, compared to US$11.7 million in 2023. Please refer to the section in this press release titled 'Reconciliation of GAAP and Non-GAAP Results' for details. Non-GAAP Financial Measures: The company uses non-GAAP net loss and non-GAAP net loss per ordinary shares for the year, which are non-GAAP financial measures, in evaluating its operating results and for financial and operational decision-making purposes. The company believes that non-GAAP net loss and non-GAAP net loss per ordinary shares for the year help identify underlying trends in the company's business that could otherwise be distorted by the effect of certain expenses that the company includes in its loss for the year. The company believes that non-GAAP net loss and non-GAAP net loss per ordinary shares for the year provide useful information about its results of operations, enhances the overall understanding of its past performance and future prospects and allows for greater visibility with respect to key metrics used by its management in its financial and operational decision-making. Non-GAAP net loss and non-GAAP net loss per ordinary shares for the year should not be considered in isolation or construed as an alternative to operating profit, loss for the year or any other measure of performance or as an indicator of its operating performance. Investors are encouraged to review non-GAAP net loss and non-GAAP net loss per ordinary shares for the year and the reconciliation to their most directly comparable GAAP measures. Non-GAAP net loss and non-GAAP net loss per ordinary shares for the year here may not be comparable to similarly titled measures presented by other companies. Other companies may calculate similarly titled measures differently, limiting their usefulness as comparative measures to the company's data. The company encourages investors and others to review its financial information in its entirety and not rely on a single financial measure. Non-GAAP net loss and non-GAAP net loss per ordinary shares for the year represent net loss attributable to ordinary shareholders for the year excluding share-based compensation expenses. Share-based compensation expense is a non-cash expense arising from the grant of stock-based awards to employees. The company believes that the exclusion of share-based compensation expenses from the net loss in the 'Reconciliation of GAAP and Non-GAAP Results' assists management and investors in making meaningful period-to-period comparisons in the company's operating performance or peer group comparisons because (i) the amount of share-based compensation expenses in any specific period may not directly correlate to the company's underlying performance, (ii) such expenses can vary significantly between periods as a result of the timing of grants of new stock-based awards, and (iii) other companies may use different forms of employee compensation or different valuation methodologies for their share-based compensation. Please see the 'Reconciliation of GAAP and Non-GAAP Results' included in this press release for a full reconciliation of non-GAAP net loss and non-GAAP net loss per ordinary shares for the year to net loss attributable to ordinary shareholders for the year. About Adagene Adagene Inc. (Nasdaq: ADAG) is a platform-driven, clinical-stage biotechnology company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies. Adagene combines computational biology and artificial intelligence to design novel antibodies that address globally unmet patient needs. The company has forged strategic collaborations with reputable global partners that leverage its SAFEbody® precision masking technology in multiple approaches at the vanguard of science. Powered by its proprietary Dynamic Precision Library (DPL) platform, composed of NEObody™, SAFEbody, and POWERbody™ technologies, Adagene's highly differentiated pipeline features novel immunotherapy programs. The company's SAFEbody technology is designed to address safety and tolerability challenges associated with many antibody therapeutics by using precision masking technology to shield the binding domain of the biologic therapy. Through activation in the tumor microenvironment, this allows for tumor-specific targeting of antibodies in tumor microenvironment, while minimizing on-target off-tumor toxicity in healthy tissues. Adagene's lead clinical program, ADG126 (muzastotug), is a masked, anti-CTLA-4 SAFEbody that targets a unique epitope of CTLA-4 in regulatory T cells (Tregs) in the tumor microenvironment. ADG126 is currently in phase 1b/2 clinical studies in combination with anti-PD-1 therapy, particularly focused on Metastatic Microsatellite-stable (MSS) Colorectal Cancer (CRC). Validated by ongoing clinical research, the SAFEbody platform can be applied to a wide variety of antibody-based therapeutic modalities, including Fc empowered antibodies, antibody-drug conjugates, and bi/multispecific T-cell engagers. For more information, please visit: SAFEbody® is a registered trademark in the United tates, China, Australia, Japan, Singapore, and the European Union. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Safe Harbor Statement This press release contains forward-looking statements, including statements regarding certain clinical results of ADG126, the potential implications of clinical data for patients, and Adagene's advancement of, and anticipated preclinical activities, clinical development, regulatory milestones, and commercialization of its product candidates. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to Adagene's ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or regulatory approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of Adagene's drug candidates; Adagene's ability to achieve commercial success for its drug candidates, if approved; Adagene's ability to obtain and maintain protection of intellectual property for its technology and drugs; Adagene's reliance on third parties to conduct drug development, manufacturing and other services; Adagene's limited operating history and Adagene's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; Adagene's ability to enter into additional collaboration agreements beyond its existing strategic partnerships or collaborations, and the impact of the COVID-19 pandemic on Adagene's clinical development, commercial and other operations, as well as those risks more fully discussed in the 'Risk Factors' section in Adagene's filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Adagene, and Adagene undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. Investor Contacts: Raymond Tam Unaudited Consolidated Balance Sheets December 31, 2023 December 31, 2024 US$ US$ ASSETS Current assets: Cash and cash equivalents 109,934,257 85,194,502 Amounts due from related parties 222,027 8,309 Prepayments and other current assets 3,287,445 2,575,194 Total current assets 113,443,729 87,778,005 Property, equipment and software, net 1,835,121 1,125,389 Operating lease right-of-use assets 365,103 283,645 Other non‑current assets 84,885 81,386 TOTAL ASSETS 115,728,838 89,268,425 LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities: Accounts payable 3,093,752 4,241,773 Amounts due to related parties 16,714,326 13,187,966 Accruals and other current liabilities 3,001,508 2,816,038 Income tax payable 52,884 5,265 Short‑term borrowings 4,235,673 4,868,956 Current portion of long-term borrowings 4,161,549 12,923,599 Current portion of operating lease liabilities 195,955 141,341 Total current liabilities 31,455,647 38,184,938 Long‑term borrowings 13,540,034 417,339 Operating lease liabilities 173,660 142,304 TOTAL LIABILITIES 45,169,341 38,744,581 Commitments and contingencies Shareholders' equity: Ordinary shares (par value of US$0.0001 per share; 640,000,000 shares authorized, and 55,145,839 shares issued and outstanding as of December 31, 2023; and 640,000,000 shares authorized, and 58,886,944 shares issued and outstanding as of December 31, 2024) 5,547 5,889 Treasury shares, at cost (1 share as of December 31, 2023 and nil as of December 31, 2024) (4) — Additional paid‑in capital 350,105,518 362,220,445 Accumulated other comprehensive loss (1,800,088) (526,903) Accumulated deficit (277,751,476) (311,175,587) Total shareholders' equity 70,559,497 50,523,844 TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY 115,728,838 89,268,425 Unaudited Consolidated Statements of Comprehensive Loss For the Year Ended December 31, 2023 For the Year Ended December 31, 2024 US$ US$ Revenues Licensing and collaboration revenue 18,111,491 103,204 Operating expenses and income Research and development expenses (36,639,146) (28,781,412) Third parties (33,978,642) (26,837,889) Related parties (2,660,504) (1,943,523) Administrative expenses (8,672,843) (7,273,335) Other operating income, net 3,480,632 — Loss from operations (23,719,866) (35,951,543) Interest and investment income 4,283,085 3,801,345 Interest expense (1,107,820) (851,874) Other income, net 1,843,437 466,620 Foreign exchange gain (loss), net 1,446,202 (906,212) Loss before income tax (17,254,962) (33,441,664) Income tax benefit (expense) (1,691,408) 17,553 Net loss attributable to Adagene Inc.'s shareholders (18,946,370) (33,424,111) Other comprehensive income (loss) Foreign currency translation adjustments, net of nil tax (950,783) 1,273,185 Total comprehensive loss attributable to Adagene Inc.'s shareholders (19,897,153) (32,150,926) Net loss attributable to Adagene Inc.'s shareholders (18,946,370) (33,424,111) Net loss attributable to ordinary shareholders (18,946,370) (33,424,111) Weighted average number of ordinary shares used in per share calculation: —Basic 54,737,530 56,287,903 —Diluted 54,737,530 56,287,903 Net loss per ordinary share —Basic (0.35) (0.59) —Diluted (0.35) (0.59) Reconciliation of GAAP and Non-GAAP Results For the Year Ended December 31, 2023 For the Year Ended December 31, 2024 US$ US$ GAAP net loss attributable to ordinary shareholders (18,946,370) (33,424,111) Add back: Share-based compensation expenses 7,271,700 4,909,573 Non-GAAP net loss (11,674,670) (28,514,538) Weighted average number of ordinary shares used in per share calculation: —Basic 54,737,530 56,287,903 —Diluted 54,737,530 56,287,903 Non-GAAP net loss per ordinary share —Basic (0.21) (0.51) —Diluted (0.21) (0.51)
Associated Press
11-03-2025
- Business
- Associated Press
Xilio Therapeutics Announces Pipeline and Business Updates and Fourth Quarter and Full Year 2024 Financial Results
Additional Phase 2 data for vilastobart, a tumor-activated, Fc-enhanced anti-CTLA-4, in combination with atezolizumab in patients with MSS CRC anticipated in the middle of 2025 Advancing masked T cell engager programs in novel ATACR and SEECR formats for PSMA, CLDN18.2 and STEAP1 Announced collaboration with AbbVie in the first quarter of 2025 to develop novel tumor-activated, antibody-based immunotherapies, including masked T cell engagers WALTHAM, Mass., March 11, 2025 (GLOBE NEWSWIRE) -- Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with cancer, today announced pipeline progress and business updates and reported financial results for the fourth quarter and full year ended December 31, 2024. 'We started 2025 with multiple promising updates across our pipeline, including encouraging initial Phase 2 combination data for vilastobart, our tumor-activated anti-CTLA-4, in patients with late-line MSS CRC, a difficult to treat, immunologically cold tumor type that is increasing in incidence, particularly in younger people,' said René Russo, Pharm.D., president and chief executive officer of Xilio. 'These data included a preliminary 27% objective response rate in patients without liver metastases and continue to support a differentiated safety profile, including a low incidence of immune-related adverse events and only 5% of patients reporting colitis. We look forward to reporting additional data from the ongoing Phase 2 trial in the middle of this year.' Dr. Russo added, 'In addition, we are excited to be advancing multiple novel masked T cell engager programs internally and as part of our recently announced collaboration with AbbVie. Each of these programs leverages our clinically-validated, tumor-activation technology, which we believe has great potential to enhance the activity and tolerability of T cell engagers and open up promising new targets within this class of immunotherapies.' Pipeline and Business Updates Vilastobart: tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4 Vilastobart is an investigational tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4 monoclonal antibody designed to block CTLA-4 and deplete regulatory T cells when activated in the tumor microenvironment (TME). In January 2025, Xilio announced encouraging initial data from its ongoing Phase 2 clinical trial evaluating vilastobart at a dose of 100 mg once every six weeks (Q6W) in combination with atezolizumab (Tecentriq®) at 1200 mg once every three weeks (Q3W) in patients with metastatic microsatellite stable colorectal cancer (MSS CRC). As of a data cutoff date of January 13, 2025, these data demonstrated a preliminary 27% objective response rate in patients without liver metastases, and responses were accompanied by decreases in levels of serum tumor biomarkers (carcinoembryonic antigen and circulating tumor DNA) as well as improvement in clinical symptoms. In addition, as of the data cutoff date, the combination was generally well-tolerated, with patients experiencing a low incidence of immune-related adverse events and only 5% of patients reporting colitis. These safety data continue to support the potential for vilastobart to be a differentiated next-generation anti-CTLA-4 in combination with PD-(L)1 inhibitors. For more information, read the press release here. Xilio expects to report updated data from the Phase 2 clinical trial in the middle of 2025, including additional response assessments and follow-up. In addition, Xilio continues to enroll patients in Phase 1C (combination dose escalation) evaluating vilastobart at the 150 mg Q6W dose level in combination with atezolizumab at 1200 mg Q3W. Based on the promising initial Phase 2 proof-of-concept data, Xilio plans to seek opportunities for partnering to accelerate and expand further development of vilastobart. XTX301: tumor-activated IL-12 XTX301 is an investigational tumor-activated IL-12 designed to potently stimulate anti-tumor immunity and reprogram the TME of poorly immunogenic 'cold' tumors towards an inflamed or 'hot' state. In March 2024, Xilio entered into an exclusive license agreement with Gilead Sciences, Inc. (Gilead) related to Xilio's tumor-activated IL-12 program, including XTX301. In December 2024, Xilio announced preliminary data from its ongoing Phase 1 clinical trial of XTX301 in patients with advanced solid tumors. As of the data cutoff date of November 25, 2024, XTX301 was generally well-tolerated, and no patients experienced a dose limiting toxicity or a dose reduction due to a treatment-related adverse event. In addition, XTX301 showed evidence of sustained interferon gamma signaling without evidence of tachyphylaxis throughout treatment cycles. Tachyphylaxis has historically limited other IL-12 agents. For more information, read the press release here. A maximum tolerated dose has not yet been established, and Xilio continues to enroll patients in Phase 1A monotherapy dose escalation and Phase 1B monotherapy dose expansion of the ongoing Phase 1 clinical trial of XTX301. XTX501: masked PD-1/IL-2 bispecific XTX501 is a novel, tumor-activated bispecific PD-1/IL-2 designed to selectively stimulate PD-1 positive, antigen-experienced T cells and enhance their function. XTX501 incorporates masking designed to overcome IL-2 receptor-mediated clearance and peripheral activity. In preclinical studies, XTX501 demonstrated robust monotherapy activity (including in settings insensitive to PD-1) and tumor-selective pharmacodynamics consistent with its intended mechanism of action. Xilio is currently advancing XTX501 in investigational new drug (IND) application enabling studies and plans to submit an IND application for XTX501 in the middle of 2026. Masked T Cell Engager Programs Xilio is leveraging its proprietary, clinically-validated tumor-activation platform to advance multiple preclinical programs for masked T cell engagers, including wholly-owned programs targeting the tumor-associated antigens for PSMA, CLDN18.2 and STEAP1 and an additional program in collaboration with AbbVie. Xilio's masked T cell engager programs include bispecific molecules designed using its advanced tumor-activated cell engager (ATACR) format, which consists of a T cell engager with a masked CD3 targeting domain, and tri-specific molecules designed using its selective effector-enhanced cell engager (SEECR) format. The SEECR format builds upon the ATACR format by adding co-stimulatory signaling designed to further enhance potency and T cell activation. PSMA has demonstrated potential as a T cell engager target for prostate cancer. Xilio anticipates nominating a development candidate for its PSMA program in the ATACR format in the third quarter of 2025 and submitting an IND application in the first quarter of 2027. CLDN18.2 has broad potential as a T cell engager target for gastric, pancreatic, esophageal and lung cancers. Xilio anticipates nominating a development candidate for its CLDN18.2 program in the ATACR format in the fourth quarter of 2025 and submitting an IND application in the second quarter of 2027. STEAP1 has broad potential as a T cell engager target for prostate, colorectal and lung cancers. Xilio anticipates nominating a development candidate for its STEAP1 program in the SEECR format in the first half of 2026 and submitting an IND application in the second half of 2027. Corporate Updates In February 2025, Xilio announced a collaboration, license and option agreement with AbbVie leveraging Xilio's proprietary tumor-activation technology and platform to discover and develop novel tumor-activated immunotherapies, including masked T cell engagers. In the first quarter of 2025, Xilio received $52.0 million in upfront payments from AbbVie, including a $10.0 million equity investment, and Xilio will be eligible to receive up to approximately $2.1 billion in total contingent payments for option-related fees and milestones plus tiered royalties. For more information, read the joint press release here. In December 2024, Xilio announced the appointment of Caroline Hensley as chief legal officer. Year-End and Fourth Quarter 2024 Financial Results Cash Position: Cash and cash equivalents were $55.3 million as of December 31, 2024, compared to $44.7 million as of December 31, 2023. In the first quarter of 2025, Xilio received $52.0 million in upfront payments in connection with the collaboration agreement with AbbVie. License Revenue: License revenue was $1.7 million for the quarter ended December 31, 2024, and $6.3 million for the year ended December 31, 2024, which consisted of revenue recognized under the license agreement and stock purchase agreement with Gilead. No license revenue was recognized for the quarter and year ended December 31, 2023. Research & Development (R&D) Expenses: R&D expenses were $8.8 million for the quarter ended December 31, 2024, compared to $11.7 million for the quarter ended December 31, 2023. R&D expenses were $41.2 million for the year ended December 31, 2024, compared to $52.1 million for the year ended December 31, 2023. The year-over-year decrease was primarily driven by decreased clinical development activities for XTX202, a masked IL-2, as a result of discontinuing further investment in XTX202, decreased spending related to early-stage programs and indirect research and development costs, decreased personnel-related costs and decreased manufacturing costs for XTX301, partially offset by increased clinical development activities for vilastobart and XTX301. General & Administrative (G&A) Expenses: G&A expenses were $6.5 million for the quarter ended December 31, 2024, compared to $6.4 million for the quarter ended December 31, 2023. G&A expenses were $24.8 million for the year ended December 31, 2024, compared to $27.0 million for the year ended December 31, 2023. The year-over-year decrease was primarily driven by decreases in personnel-related costs, professional and consulting fees and directors' and officers' liability insurance, partially offset by an increase in legal fees. Net Loss: Net loss was $13.1 million for the quarter ended December 31, 2024, compared to $17.7 million for the quarter ended December 31, 2023. Net loss was $58.2 million for the year ended December 31, 2024, compared to $76.4 million for the year ended December 31, 2023. Financial Guidance Based on its current operating plans, Xilio anticipates that its cash and cash equivalents as of December 31, 2024, together with the $52.0 million in upfront payments received in the first quarter of 2025 in connection with the collaboration agreement with AbbVie, will be sufficient to enable it to fund its operating expenses and capital expenditure requirements into the first quarter of 2026. About Vilastobart and the Phase 1/2 Combination Clinical Trial Vilastobart is an investigational tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4 monoclonal antibody designed to block CTLA-4 and deplete regulatory T cells when activated in the tumor microenvironment (TME). In 2023, Xilio entered into a co-funded clinical trial collaboration with Roche to evaluate vilastobart in combination with atezolizumab (Tecentriq®) in a multi-center, open-label Phase 1/2 clinical trial. Xilio is currently evaluating the safety of the combination in Phase 1C dose escalation in patients with advanced solid tumors and the safety and efficacy of the combination in Phase 2 in patients with metastatic microsatellite stable colorectal cancer with and without liver metastases. Please refer to NCT04896697 on for additional details. About XTX301 and the Phase 1 Clinical Trial XTX301 is an investigational masked IL-12 designed to potently stimulate anti-tumor immunity and reprogram the tumor microenvironment (TME) of poorly immunogenic 'cold' tumors towards an inflamed or 'hot' state. In March 2024, Xilio entered into an exclusive license agreement with Gilead Sciences, Inc. for Xilio's tumor-activated IL-12 program, including XTX301. Xilio is currently evaluating the safety and tolerability of XTX301 as a monotherapy in patients with advanced solid tumors in a first-in-human, multi-center, open-label Phase 1 clinical trial. Please refer to NCT05684965 on for additional details. About Xilio Therapeutics Xilio Therapeutics is a clinical-stage biotechnology company discovering and developing tumor-activated, or masked, immuno-oncology (I-O) therapies with the goal of significantly improving outcomes for people living with cancer without the systemic side effects of current I-O treatments. The company is leveraging its proprietary platform to advance a pipeline of novel, tumor-activated I-O molecules that are designed to optimize the therapeutic index by localizing anti-tumor activity within the tumor microenvironment. Learn more by visiting and follow us on LinkedIn ( Xilio Therapeutics, Inc.). Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding plans, expectations, development timelines and anticipated milestones for Xilio's programs; the receipt of future contingent payments under Xilio's collaboration or partnership agreements with Roche, Gilead and AbbVie; the potential benefits of any of Xilio's current or future product candidates in any indication; the sufficiency of, and the period in which Xilio expects to have, cash to fund its operations, capital expenditure requirements, and development plans and milestones; and Xilio's strategy, goals and anticipated financial performance, milestones, business plans and focus. The words 'aim,' 'may,' 'will,' 'could,' 'would,' 'should,' 'expect,' 'plan,' 'anticipate,' 'intend,' 'believe,' 'estimate,' 'predict,' 'project,' 'potential,' 'continue,' 'seek,' 'target' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of important risks, uncertainties and other factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks related to general market conditions and geopolitical uncertainties; risks and uncertainties related to ongoing and planned research and development activities, including initiating, conducting or completing preclinical studies and clinical trials and the timing and results of such preclinical studies or clinical trials; the delay of any current or planned preclinical studies or clinical trials or the development of Xilio's current or future product candidates; Xilio's ability to obtain and maintain sufficient preclinical and clinical supply of current or future product candidates; Xilio's ability to advance multiple early-stage masked T cell engager programs; initial, preliminary or interim preclinical or clinical data or results may not be replicated in or predictive of future preclinical or clinical data or results; Xilio's ability to successfully demonstrate the safety and efficacy of its product candidates and gain approval of its product candidates on a timely basis, if at all; results from preclinical studies or clinical trials for Xilio's product candidates may not support further development of such product candidates; actions of regulatory agencies may affect the initiation, timing and progress of current or future clinical trials; Xilio's ability to obtain, maintain and enforce patent and other intellectual property protection for current or future product candidates; Xilio's need to obtain additional cash resources to fund its operations beyond the first quarter of 2026, including to advance its pipeline of tumor-activated I-O molecules; the impact of international trade policies on Xilio's business, including U.S. and China trade policies; and Xilio's ability to maintain its collaboration or partnership agreements with Roche, Gilead and AbbVie. These and other risks and uncertainties are described in greater detail in the sections entitled 'Risk Factor Summary' and 'Risk Factors' in Xilio's filings with the U.S. Securities and Exchange Commission ('SEC'), including Xilio's most recent Quarterly Report on Form 10-Q and any other filings that Xilio has made or may make with the SEC in the future. Any forward-looking statements contained in this press release represent Xilio's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, Xilio explicitly disclaims any obligation to update any forward-looking statements. This press release contains hyperlinks to information that is not deemed to be incorporated by reference in this press release. TECENTRIQ is a registered trademark of Genentech USA, Inc., a member of the Roche Group. Investor and Media Contact [email protected] XILIO THERAPEUTICS, INC. Condensed Consolidated Balance Sheets (In thousands) (Unaudited) December 31, 2024 December 31, 2023 Assets Cash and cash equivalents $ 55,291 $ 44,704 Other assets 15,784 16,222 Total assets $ 71,075 $ 60,926 Liabilities and Stockholders' Equity Liabilities Deferred revenue $ 32,780 $ — Other liabilities 20,697 24,099 Total liabilities $ 53,477 $ 24,099 Stockholders' equity 17,598 36,827 Total liabilities and stockholders' equity $ 71,075 $ 60,926 XILIO THERAPEUTICS, INC. Condensed Consolidated Statements of Operations and Comprehensive Loss (In thousands, except share and per share data) (Unaudited) Three Months Ended December 31, Years Ended December 31, 2024 2023 2024 2023 License revenue $ 1,724 $ — $ 6,344 $ — Operating expenses (1) Research and development 8,836 11,736 41,211 52,136 General and administrative 6,517 6,394 24,778 26,997 Restructuring — — 937 — Total operating expenses 15,353 18,130 66,926 79,133 Loss from operations (13,629) (18,130) (60,582) (79,133) Other income, net 536 475 2,341 2,729 Net loss and comprehensive loss $ (13,093) $ (17,655) $ (58,241) $ (76,404) Net loss per share, basic and diluted $ (0.20) $ (0.64) $ (1.09) $ (2.78) Weighted average common shares outstanding, basic and diluted (2) 64,675,807 27,557,021 53,511,424 27,496,107 (1) Operating expenses include the following amounts of non-cash stock-based compensation expense: Three Months Ended December 31, Years Ended December 31, 2024 2023 2024 2023 Research and development expense $ 377 $ 519 $ 1,652 $ 2,189 General and administrative expense 1,139 1,411 4,782 5,193 Total stock-based compensation expense $ 1,516 $ 1,930 $ 6,434 $ 7,382 (2) Weighted average common shares outstanding, basic and diluted, includes prefunded warrants to purchase common stock and excludes shares of restricted common stock that were not vested as of the applicable period.
