On May 9, 2024 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, reported a business update and announced financial results for the first quarter ended March 31, 2024 (Press release, Mersana Therapeutics, MAY 9, 2024, View Source [SID1234643005]).
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"In recent months, we presented new preclinical and clinical Dolasynthen data demonstrating our next-generation cytotoxic ADC platform’s potential to reduce adverse events that limit other ADC platforms," said Martin Huber, M.D., President and Chief Executive Officer of Mersana Therapeutics. "Given this emerging platform profile and the objective responses we have seen to date with XMT-1660, we are continuing to advance Phase 1 dose escalation and backfill cohorts in parallel to optimize our dose, schedule and biomarker prior to initiating expansion. Additionally, we are pleased to have resumed patient recruitment in our Phase 1 clinical trial of XMT-2056 and look forward to advancing dose escalation this year."
Recent Accomplishments, Strategic Priorities and Expected Milestones
XMT-1660: Mersana continues to advance its Phase 1 clinical trial of XMT-1660, the company’s lead Dolasynthen ADC candidate targeting B7-H4. The dose escalation portion of the trial is ongoing, a maximum tolerated dose has yet to be established and enrollment of patients in backfill cohorts to optimize dose and schedule continues. Mersana plans to share initial dose escalation and backfill cohort data and initiate the expansion portion of the trial in the second half of 2024.
XMT-2056: In the first quarter of 2024, Mersana reopened clinical sites and resumed patient recruitment for its Phase 1 clinical trial of XMT-2056, the company’s lead Immunosynthen ADC candidate targeting a novel HER2 epitope, following the lifting of a clinical hold on the trial in the fourth quarter of 2023. The company plans to advance dose escalation in this trial in 2024. GSK plc has an exclusive global license option to co-develop and commercialize XMT-2056.
Collaborations: Mersana continues to advance its Johnson & Johnson and Merck KGaA, Darmstadt, Germany collaborations. The Johnson & Johnson collaboration and license agreement focuses on the discovery of novel Dolasynthen ADCs for up to three targets. The Merck KGaA, Darmstadt, Germany collaboration and license agreement focuses on the discovery of novel Immunosynthen ADCs for up to two targets.
Dolasynthen Platform Differentiation: At the European Society of Gynaecological Oncology (ESGO) 2024 Congress in March 2024 and the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2024 Annual Meeting in April 2024, preclinical and clinical data were presented demonstrating a reduction in presumed off-target platform toxicities with an ADC developed utilizing Dolasynthen, the company’s next-generation platform, compared with one developed using the company’s first-generation platform.
First Quarter 2024 Financial Results
Cash, cash equivalents and marketable securities as of March 31, 2024 were $183.1 million. Mersana continues to expect that its capital resources will be sufficient to support its current operating plan commitments into 2026.
Net cash used in operating activities for the first quarter of 2024 was $32.7 million.
Collaboration revenue for the first quarter of 2024 was $9.2 million, compared to $7.8 million for the same period in 2023. The year-over-year change was primarily related to the company’s Johnson & Johnson collaboration, including both research and CMC activities.
Research and development (R&D) expenses for the first quarter of 2024 were $18.7 million, compared to $47.3 million for the same period in 2023. Included in the first quarter of 2024 R&D expenses were $2.5 million in non-cash stock-based compensation expenses. The year-over-year decline in R&D expenses was primarily related to reduced costs associated with manufacturing and clinical activities for UpRi and reduced employee compensation following the restructuring announced by the company in July 2023.
General and administrative (G&A) expenses for the first quarter of 2024 were $11.6 million, compared to $18.3 million during the same period in 2023. Included in the first quarter of 2024 G&A expenses were $2.1 million in non-cash stock-based compensation expenses. The year-over-year decline in G&A expenses was primarily related to reduced consulting and professional services fees and reduced employee compensation expense following the aforementioned restructuring.
Net loss for the first quarter of 2024 was $19.3 million, or $0.16 per share, compared to a net loss of $56.2 million, or $0.52 per share, for the same period in 2023.
Conference Call Reminder
Mersana will host a conference call today at 8:00 a.m. ET to discuss business updates and its financial results for the first quarter of 2024. To access the call, please dial 833-255-2826 (domestic) or 412-317-0689 (international). A live webcast of the presentation will be available on the Investors & Media section of the Mersana website at www.mersana.com, and a replay of the webcast will be available in the same location following the conference call for approximately 90 days.