Mersana Therapeutics Provides Business Update and Announces Fourth Quarter and Full Year 2024 Financial Results

Rhea-AI Summary

Mersana Therapeutics (NASDAQ: MRSN) has reported its Q4 and full year 2024 financial results, highlighting significant progress in its clinical development programs. The company announced positive initial Phase 1 data for Emi-Le, its B7-H4-targeting ADC candidate, and received an additional Fast Track designation from the FDA.

Key financial metrics for Q4 2024:

• Cash position: $134.6 million as of December 31, 2024
• Collaboration revenue: $16.4 million (up from $10.7 million in Q4 2023)
• Net loss: $14.1 million ($0.11 per share)
• R&D expenses: $22.3 million
• G&A expenses: $8.9 million

For full year 2024, the company reported collaboration revenue of $40.5 million and a net loss of $69.2 million ($0.56 per share). Mersana expects its current capital resources to support operations into 2026.

Positive

• Received additional FDA Fast Track designation for Emi-Le
• Positive Phase 1 data from 130 patients for Emi-Le
• Collaboration revenue increased to $16.4M in Q4 2024 (vs $10.7M in Q4 2023)
• Reduced net loss to $69.2M in 2024 from $171.7M in 2023
• Strong cash position of $134.6M with runway into 2026

Negative

• Continued quarterly net loss of $14.1M in Q4 2024
• Increased R&D expenses to $22.3M in Q4 2024 from $21.5M in Q4 2023

Insights

Financial Analyst

Mersana's Q4 and full-year 2024 results illustrate a significant financial improvement amid promising clinical developments. Their net loss narrowed substantially to $69.2 million ($0.56/share) for 2024, down from $171.7 million ($1.48/share) in 2023. This 59.7% reduction reflects successful restructuring efforts and strategic pipeline focus.

The company reported Q4 collaboration revenue of $16.4 million, up 53.3% from the year-ago period, driven primarily by their partnerships with Johnson & Johnson, Merck KGaA, and GSK. Their cash position of $134.6 million provides runway into 2026, giving them critical development flexibility for their ADC pipeline.

Operational efficiency improvements are evident, with R&D expenses decreasing to $73.0 million from $148.3 million in 2023, and G&A expenses reduced to $40.8 million from $59.5 million. Cash burn appears manageable at $19.3 million for Q4.

The FDA Fast Track designation for Emi-Le represents a regulatory milestone that could accelerate development timelines and reduce costs. The positive initial Phase 1 data and expansion into triple-negative breast cancer patients previously treated with topo-1 ADCs positions Mersana in a competitive oncology space with substantial market potential. Their current enterprise value appears to undervalue these clinical and partnership assets if Emi-Le continues to demonstrate promising efficacy and safety data.

Oncology Specialist

Mersana's clinical progress with Emi-Le (emiltatug ledadotin) represents a significant development in the B7-H4-targeted ADC landscape. The initial Phase 1 data from 130 patients shows promising activity across multiple tumor types, with particular emphasis on heavily pretreated triple-negative breast cancer (TNBC)—an area with substantial unmet medical need.

The expansion cohort at 67.4 mg/m² administered every four weeks in TNBC patients previously treated with topoisomerase-1 inhibitor ADCs is especially noteworthy. This population has treatment options after progression on existing therapies like sacituzumab govitecan (Trodelvy). The differentiated tolerability profile mentioned suggests potential for combination approaches, which could distinguish Emi-Le from competitors in the B7-H4 space.

The second FDA Fast Track designation specifically for HER2-negative breast cancer patients previously treated with topo-1 ADCs validates the potential clinical significance of this approach. This designation enables more frequent FDA interactions, potential for accelerated approval, and priority review.

Their parallel exploration of higher doses in escalation cohorts while advancing the expansion phase demonstrates a sophisticated development strategy to optimize therapeutic window. The company's plan to initiate a second expansion cohort at a different dose level indicates confidence in the preliminary efficacy signals.

The advancement of XMT-2056, targeting a novel HER2 epitope with their Immunosynthen platform (STING agonist payload), represents a mechanistically distinct approach that could complement their cytotoxic ADC portfolio. The planned pharmacodynamic data readout will be important to validate this immune-stimulating ADC approach.

• Announced positive initial Phase 1 clinical data and an additional Fast Track designation for Emi-Le
• Initiated first expansion cohort in patients with triple-negative breast cancer (TNBC) previously treated with at least one topoisomerase-1 inhibitor (topo-1) ADC
• Plan to present additional clinical data from dose escalation and backfill cohorts in 2025
• Conference call today at 8:00 a.m. ET

CAMBRIDGE, Mass., March 03, 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 provided a business update and reported financial results for the fourth quarter and full year ended December 31, 2024.

“We made significant progress advancing the clinical development of Emi-Le in 2024,” said Martin Huber, M.D., President and Chief Executive Officer of Mersana Therapeutics. “These efforts enabled us to begin 2025 by announcing positive initial Phase 1 clinical data, the initiation of expansion and a Fast Track designation for HER2-negative breast cancer patients who have previously been treated with at least one topo-1 ADC. With promising monotherapy activity reported in patients across multiple tumors, including those with heavily pretreated triple-negative breast cancer, as well as a differentiated tolerability profile that may enable combination approaches, we believe Emi-Le offers us unique development opportunities that are unavailable to other B7-H4 ADCs.”

Emiltatug Ledadotin (Emi-Le; XMT-1660)
In January 2025, Mersana announced positive initial Phase 1 clinical data for Emi-Le, the company’s lead Dolasynthen ADC candidate targeting B7-H4, from 130 patients who were enrolled in dose escalation and backfill cohorts as of a December 13, 2024 data cutoff. The company also announced that Emi-Le had received a second Fast Track designation from the U.S. Food and Drug Administration (FDA).

The expansion portion of the company’s Phase 1 clinical trial continues at a dose of 67.4 mg/m² administered every four weeks in patients with TNBC who had received one to four prior lines of therapy, including at least one topo-1 ADC. In parallel, the company continues to explore higher doses in dose escalation and backfill cohorts to identify a second dose for expansion.

In 2025, Mersana plans to initiate expansion enrollment at a second dose in patients with TNBC who have received one to four prior lines of treatment, including at least one prior topo-1 ADC. The company also plans to present additional Phase 1 clinical data from dose escalation and backfill cohorts in 2025.

XMT-2056
Mersana has continued to advance the dose escalation portion of its Phase 1 clinical trial of XMT-2056, the company's lead Immunosynthen ADC candidate targeting a novel HER2 epitope. GSK plc has an exclusive global license option to co-develop and commercialize XMT-2056. Mersana plans to continue enrolling patients in dose escalation and expects to present initial clinical pharmacodynamic STING activation data for XMT-2056 in 2025.

Collaborations
Mersana continues to advance its collaborations with both Johnson & Johnson (Dolasynthen research collaboration) and Merck KGaA, Darmstadt, Germany (Immunosynthen research collaboration).

Fourth Quarter 2024 Financial Results

• Cash, cash equivalents and marketable securities as of December 31, 2024 were $134.6 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 fourth quarter of 2024 was $19.3 million.
• Collaboration revenue for the fourth quarter of 2024 was $16.4 million, compared to $10.7 million for the same period in 2023. The year-over-year change was primarily related to increased collaboration revenue recognized under Mersana’s collaboration and license agreements with Johnson & Johnson, Merck KGaA, Darmstadt, Germany and GSK.
• Research and development (R&D) expenses for the fourth quarter of 2024 were $22.3 million, compared to $21.5 million for the same period in 2023. Included in the fourth quarter of 2024 R&D expenses were $1.7 million in non-cash stock-based compensation expenses. The year-over-year increase in R&D expenses was primarily related to increased costs associated with manufacturing and clinical development activities for Emi-Le and XMT-2056, primarily offset by reduced costs related to clinical development activities for UpRi, a discontinued ADC candidate.
• General and administrative (G&A) expenses for the fourth quarter of 2024 were $8.9 million, compared to $10.1 million during the same period in 2023. Included in the fourth quarter of 2024 G&A expenses were $1.7 million in non-cash stock-based compensation expenses. The year-over-year decline in G&A expenses was primarily related to reduced employee compensation expense following the company’s 2023 restructuring and reduced consulting and professional services fees.
• Net loss for the fourth quarter of 2024 was $14.1 million, or $0.11 per share, compared to a net loss of $19.5 million, or $0.16 per share, for the same period in 2023.

Full Year 2024 Financial Results

• Net cash used in operating activities for full year 2024 was $82.3 million.
• Collaboration revenue for full year 2024 was $40.5 million, compared to $36.9 million for 2023. The year-over-year increase was primarily related to incremental milestone payments associated with the company’s Johnson and Johnson collaboration and license agreement.
• R&D expenses for full year 2024 were $73.0 million, compared to $148.3 million for the full year 2023. Included in 2024 R&D expenses were $8.9 million in non-cash stock-based compensation expenses. The decline in R&D expenses was primarily related to reduced costs associated with manufacturing and clinical development activities for UpRi, reduced employee compensation expenses following the company’s restructuring in 2023, and reduced consulting and professional services fees, partially offset by increased costs for clinical development activities for Emi-Le.
• G&A expenses for full year 2024 were $40.8 million, compared to $59.5 million for the full year 2023. Included in 2024 G&A expenses were $7.6 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 full year 2024 was $69.2 million, or $0.56 per share, compared to a net loss of $171.7 million, or $1.48 per share, for the full year 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 fourth quarter and full year 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.

About Mersana Therapeutics
Mersana Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel antibody-drug conjugates (ADCs) and driven by the knowledge that patients are waiting for new treatment options. The company has developed proprietary cytotoxic (Dolasynthen) and immunostimulatory (Immunosynthen) ADC platforms that are generating a pipeline of wholly-owned and partnered product candidates with the potential to treat a range of cancers. Its pipeline includes Emi-Le (emiltatug ledadotin; XMT-1660), a Dolasynthen ADC targeting B7-H4, and XMT-2056, an Immunosynthen ADC targeting a novel epitope of human epidermal growth factor receptor 2 (HER2). Mersana routinely posts information that may be useful to investors on the “Investors & Media” section of its website at www.mersana.com.

Forward-Looking Statements
This press release contains “forward-looking” statements and information within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements concerning Mersana’s plans regarding the clinical development of Emi-Le and XMT-2056, including with respect to the progress and design of the clinical trials of these product candidates; the potential clinical benefits of Emi-Le; Mersana’s efforts to identify an additional dose for investigation in the expansion portion of its Phase 1 clinical trial of Emi-Le; Mersana’s planned data presentations, including with respect to its Phase 1 clinical trial of Emi-Le and to clinical pharmacodynamic STING activation data related to XMT-2056; Mersana’s collaborations with third parties; the development and potential of Mersana’s product candidates, platforms, technology and pipeline of ADC candidates; and Mersana’s expected cash runway. Mersana may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including, among other things, uncertainties inherent in research and development, in the advancement, progression and completion of clinical trials and in the clinical development of Mersana’s product candidates, including Emi-Le and XMT-2056; the risk that Mersana may face delays in patient enrollment in its Phase 1 clinical trials of Emi-Le and XMT-2056; the risk that outcomes of preclinical studies may not be predictive of clinical trial results; the risk that initial or interim results from a clinical trial may not be predictive of the final results of the trial or the results of future trials; the risk that clinical trial data may not support regulatory applications or approvals; the risk that Mersana may not realize the intended benefits of its platforms, technology and collaborations; the risk that Mersana's projections regarding its expected cash runway are inaccurate or that the conduct of its business requires more cash than anticipated; and other important factors, any of which could cause Mersana’s actual results to differ from those contained in the forward-looking statements, that are described in greater detail in the section entitled “Risk Factors” in Mersana’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (“SEC”) on November 13, 2024, as well as in other filings Mersana may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Mersana expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

Mersana Therapeutics, Inc.
Selected Condensed Consolidated Balance Sheet Data
(in thousands and unaudited)
		December 31,				December 31,
			2024				2023
Cash, cash equivalents and marketable securities		$	134,620			$	209,084
Working capital(1)			74,446				150,420
Total assets			144,663				226,060
Total stockholders' (deficit) equity			(9,509	)			36,904
(1) The company defines working capital as current assets less current liabilities.

Mersana Therapeutics, Inc.
Condensed Consolidated Statement of Operations
(in thousands, except share and per share data, and unaudited)
		Three months ended								Twelve months ended
		December 31,				December 31,				December 31,				December 31,
		2024				2023				2024				2023
Collaboration revenue		$	16,361			$	10,701			$	40,497			$	36,855
Operating expenses:
Research and development		22,286					21,495			73,020				148,269
General and administrative		8,886					10,134			40,813				59,543
Restructuring expenses		-					499			-				8,713
Total operating expenses		31,172					32,128			113,833				216,525
Total other income, net		694					1,883			4,562				8,000
Loss before income taxes		(14,117		)			(19,544	)		(68,774		)		(171,670		)
Income tax expense		-					-			(418		)		-
Net loss		$	(14,117	)		$	(19,544	)		$	(69,192	)		$	(171,670	)
Net loss per share — basic and diluted		$	(0.11	)		$	(0.16	)		$	(0.56	)		$	(1.48	)
Weighted-average number of common shares — basic and diluted		123,558,203					120,614,350			122,539,598				116,112,891

Contact:
Jason Fredette
617-498-0020
jason.fredette@mersana.com

FAQ

What were Mersana's (MRSN) Q4 2024 financial results?

In Q4 2024, Mersana reported $16.4M in collaboration revenue, $22.3M in R&D expenses, $8.9M in G&A expenses, and a net loss of $14.1M ($0.11 per share).

How much cash does Mersana (MRSN) have and what is their runway?

Mersana had $134.6M in cash, cash equivalents and marketable securities as of December 31, 2024, with runway expected into 2026.

What progress has Mersana (MRSN) made with Emi-Le in 2024?

Mersana reported positive initial Phase 1 data for Emi-Le from 130 patients, received Fast Track designation, and initiated expansion cohort in TNBC patients.

What are Mersana's (MRSN) key clinical development plans for 2025?

Mersana plans to present additional Phase 1 data for Emi-Le and initiate expansion enrollment at a second dose for TNBC patients.