31% confirmed ORR (8 responses in 26 evaluable patients) across B7-H4 high tumors at intermediate doses 44% confirmed ORR (7 responses in 16 evaluable patients) in the subset of patients with ≤4 prior lines of therapy CAMBRIDGE, Mass., June 02, 2025 (GLOBE NEWSWIRE) -- Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on the development of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, today announced additional interim Pha ...

Summary of Mersana Therapeutics Conference Call Company Overview - **Company**: Mersana Therapeutics - **Event**: Sixth Annual Oncology Innovation Summit - **Key Participants**: Marty Huber (President and CEO), Brian Deschuytner (COO and CFO) Core Industry Insights - **Industry**: Biotechnology, specifically focused on oncology and antibody-drug conjugates (ADCs) Key Points and Arguments Data Updates and Efficacy - Mersana has provided updates on their phase one data for EMILI, an ADC targeting b7-H4, showing a differentiated safety profile with effective doses and minimal side effects like neutropenia and neuropathy [4][5] - The overall response rate (ORR) for EMILI has improved from 23% to 31% across all tumor types, indicating compelling efficacy, particularly in triple-negative breast cancer (TNBC) patients who are late-line and highly refractory [5][6] - The company is focusing on the unmet need in patients who have previously received topoisomerase (topo) inhibitors, where the response rate is typically low [6][7] Regulatory Designations - Mersana has received fast track designations for EMILI in TNBC and certain breast cancer patients post-topo, indicating regulatory recognition of the unmet need in this area [7] Upcoming Presentations - The ASCO presentation will provide additional follow-up data from the ESMO breast presentation, focusing on all enrolled tumor types and more details on non-breast cancer patients [9][10] Patient Management and Protocol Adjustments - The company has implemented protocol amendments to mitigate proteinuria, a treatment-related adverse event, allowing for continued dosing in asymptomatic patients [13][17] - Early feedback from physicians indicates satisfaction with the new protocol, as it allows for better management of patients who are responding well to treatment [17][18] Dose Expansion Strategy - Mersana is exploring high-dose regimens, with a focus on increasing exposure while managing side effects. The rationale for dose selection is based on observed tumor reductions in initial datasets [25][26] - The company aims to confirm initial responses and improve the overall response rate by avoiding treatment interruptions due to adverse events [31][32] Patient Population and Biomarkers - The target population for dose expansion includes TNBC patients with prior chemotherapy, particularly those who have received at least one prior ADC [34][36] - Mersana is using a consistent assay for b7-H4 expression across different study phases, which is crucial for identifying the appropriate patient population [37][38] Trial Design Considerations - Mersana is considering a randomized pivotal trial rather than a single-arm study, as randomized trials are preferred by regulatory agencies and provide critical control data [42][45] - The company aims for a minimum response rate of 20% in the pivotal trial, significantly higher than the 5% response rate observed in control arms of previous studies [46] Additional Important Insights - The company is aware of the challenges in enrolling patients who have previously received topo inhibitors, as many investigators are hesitant to include these patients due to the lack of consistent clinical benefits [40][41] - Mersana's approach to managing adverse events and optimizing dosing schedules reflects a commitment to improving patient outcomes in a challenging therapeutic area [18][25]

Core Insights - Mersana Therapeutics, Inc. provided a business update and reported financial results for Q1 2025, focusing on the development of its antibody-drug conjugates (ADCs) targeting cancers with high unmet medical needs [2][15]. Business Update - The company is advancing the development of Emi-Le, a B7-H4-directed Dolasynthen ADC, with promising preliminary data presented at ESMO Breast Cancer 2025 [3][4]. - Encouraging clinical activity data showed an objective response rate (ORR) of 31% among evaluable patients with B7-H4 high tumors receiving intermediate doses of Emi-Le, an increase from 23% previously reported [5][7]. - The focus remains on triple-negative breast cancer (TNBC) patients, with ongoing enrollment in dose expansion cohorts [6][10]. Clinical Data - Updated clinical data from Emi-Le's Phase 1 trial indicated a median progression-free survival (PFS) of 16.0 weeks and a median overall survival (OS) of 5.7 months for patients with B7-H4 low TNBC [8]. - The company plans to report initial clinical data from the expansion portion of its Phase 1 trial in the second half of 2025 [11]. Financial Results - As of March 31, 2025, Mersana had cash and cash equivalents of $102.3 million, with net cash used in operating activities amounting to $29.3 million for Q1 2025 [15][20]. - Collaboration revenue for Q1 2025 was $2.8 million, a decrease from $9.2 million in the same period in 2024, primarily due to reduced revenue from collaboration agreements [15][16]. - The net loss for Q1 2025 was $24.1 million, or $0.19 per share, compared to a net loss of $19.3 million, or $0.16 per share, for the same period in 2024 [20][25]. Future Plans - Mersana is set to present at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting, with two presentations regarding Emi-Le planned [12]. - The company continues to support collaborations with Johnson & Johnson and Merck KGaA, focusing on the development of its ADC platforms [14].

Mersana Therapeutics, Inc. (MRSN) came out with a quarterly loss of $0.19 per share versus the Zacks Consensus Estimate of a loss of $0.21. This compares to loss of $0.16 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 9.52%. A quarter ago, it was expected that this company would post a loss of $0.16 per share when it actually produced a loss of $0.11, delivering a surprise of 31.25%.Over the last four quarters, the company ha ...

Financial Performance - The company reported net losses of $24.1 million for Q1 2025, compared to $19.3 million for Q1 2024, with an accumulated deficit of $919.7 million as of March 31, 2025[151]. - Collaboration revenue decreased by $6.5 million, from $9.2 million for the three months ended March 31, 2024 to $2.8 million for the three months ended March 31, 2025[172]. - Net loss increased by $4.8 million, from $19.3 million for the three months ended March 31, 2024 to $24.1 million for the same period in 2025[171]. - Net cash used in operating activities was $29.3 million for the three months ended March 31, 2025, compared to $32.7 million for the same period in 2024[181]. - Total operating expenses decreased by $2.98 million, from $30.2 million for the three months ended March 31, 2024 to $27.3 million for the same period in 2025[171]. - Research and development expenses totaled $18.3 million for the three months ended March 31, 2025, a decrease of $0.3 million from $18.7 million in the same period of 2024[173]. - General and administrative expenses decreased by $2.6 million, from $11.6 million for the three months ended March 31, 2024 to $8.9 million for the same period in 2025[175]. Cash Position - As of March 31, 2025, the company had cash and cash equivalents of $102.3 million, which is expected to fund operations into mid-2026[151]. - Net cash provided by investing activities was $27.0 million in Q1 2025, a significant improvement from net cash used of $72.5 million in Q1 2024, primarily due to maturities of marketable securities[183]. - Net cash used in financing activities was $3.1 million in Q1 2025, down from net cash provided of $5.8 million in Q1 2024, mainly due to debt principal payments[184]. - The company anticipates increased cash expenditures related to ongoing development, clinical trials, and potential commercialization of product candidates[185]. - As of March 31, 2025, the company has borrowed $25.0 million under the New Credit Facility, with $5.2 million of principal repaid[180]. - The company may need to raise additional funds through equity offerings, debt financings, or strategic collaborations, with no assurance of success in obtaining sufficient funding[186][189]. Clinical Development - The ongoing Phase 1 clinical trial of Emi-Le has shown a confirmed objective response rate (ORR) of 31% among evaluable patients with "B7-H4 high" tumor expression, an increase from the previous 23% reported[144]. - The company plans to report initial clinical data from the expansion portion of the Phase 1 trial of Emi-Le in the second half of 2025[145]. - The company is currently enrolling patients in the dose escalation portion of the Phase 1 trial of XMT-2056, with initial pharmacodynamic data expected in 2025[145]. - The company has entered into a global collaboration with GSK for the co-development and commercialization of XMT-2056, which targets a novel HER2 epitope[149]. - The company is focusing on advancing the clinical development of Emi-Le and XMT-2056 while reducing research activities and internal pipeline development efforts[146]. Restructuring and Cost Management - The company has implemented a strategic restructuring plan, reducing approximately 55% of its employee base, expected to be completed by Q3 2025, incurring estimated costs of $4-5 million[146][147]. - The company has discontinued the development of upifitimab rilsodotin (XMT-1536) and completed the related restructuring by December 31, 2023[148]. - Significant external costs for manufacturing and clinical trials are incurred, with total research and development costs at $18.3 million for the three months ended March 31, 2025[162]. - The company expects to incur significant research and development expenses over the next several years as it continues clinical development and manufacturing efforts[166]. Market and Risk Factors - The interest rate on the New Credit Facility is sensitive to changes, with a principal balance of $19.8 million outstanding as of March 31, 2025[195]. - The company is exposed to market risk related to interest rates, but believes that a 100 basis points change would not materially affect the fair market value of its investment portfolio[194]. - There were no material changes to contractual obligations during the three months ended March 31, 2025[192].

Mersana Therapeutics (MRSN) Q1 2025 Earnings Call May 15, 2025 08:00 AM ET Company Participants Jason Fredette - Senior Vice President of Investor Relations & Corporate CommunicationsMartin Huber - President & CEOBrian DeSchuytner - Senior VP, CFO & COOJonathan Chang - Senior Managing DirectorKarina Rabayeva - VP - Biotech Equity Research Conference Call Participants Tara Bancroft - Director, Senior Analyst, Biotech Equity ResearchCharles Zhu - Managing Director, Senior Biotechnology Research AnalystMichael ...

Mersana Therapeutics (MRSN) Q1 2025 Earnings Call May 15, 2025 08:00 AM ET Speaker0 Good morning, and welcome to the Mersana Therapeutics First Quarter twenty twenty five Conference Call. Currently, all participants are in a listen only mode. There will be a question and answer session at the end of this call. I would now like to turn the call over to Mr. Jason Fredett, Senior Vice President, Investor Relations and Corporate Communications. Please proceed, sir. Speaker1 Thank you, operator, and good morning ...

Emiltatug Ledadotin (Emi-Le; XMT-1660) Mersana has continued to advance the development of Emi-Le, the company's B7-H4-directed Dolasynthen ADC. Updated Clinical Data Presented at ESMO Breast Cancer 2025 Today: Earlier this morning at the European Society for Medical Oncology Breast Cancer 2025 Annual Congress (ESMO Breast Cancer 2025) in Munich, Germany, updated clinical data as of a March 8, 2025 data cutoff from Emi-Le's Phase 1 dose escalation and backfill cohorts were presented in a mini oral session. ...

CAMBRIDGE, Mass., May 15, 2025 (GLOBE NEWSWIRE) -- Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, today provided a business update and reported financial results for the first quarter ended March 31, 2025. "Given recent positive front-line data reported from topo-1 ADC registrational trials, we believe the post-topo-1 breast cancer patient populati ...

CAMBRIDGE, Mass., April 23, 2025 (GLOBE NEWSWIRE) -- Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, today announced that the following presentations related to emiltatug ledadotin (Emi-Le; XMT-1660), Mersana’s B7-H4-directed Dolasynthen ADC, will be given at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting taking ...