On May 15, 2025 Phio Pharmaceuticals Corp. (Nasdaq: PHIO) is a clinical-stage biopharmaceutical company developing therapeutics that use its INTASYL siRNA gene silencing technology designed to make the body’s immune cells more effective in killing cancer cells, reported its financial results for the quarter ended March 31, 2025 and provided a business update (Press release, Phio Pharmaceuticals, MAY 15, 2025, View Source [SID1234653179]).

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Recent Corporate Updates

PH-762 Clinical Progress

Phio’s ongoing Phase 1b dose escalation clinical trial (NCT 06014086) is designed to evaluate the safety and tolerability of neoadjuvant use of intratumoral PH-762 in Stages 1, 2 and 4 cutaneous squamous cell carcinoma (cSCC), Stage 4 melanoma, and Stage 4 Merkel cell carcinoma.

To date, a total of 10 patients with cutaneous carcinomas have been treated in Cohorts 1, 2 and 3. These cohorts included 9 patients with cSCC and 1 patient with metastatic melanoma. At Day 36 (planned tumor excision), of the 9 patients with cSCC, 4 patients had a pathologic complete response (100% tumor clearance). One patient had a near complete response (>90% clearance) and 1 patient had a partial response (>50% clearance). The other 3 cSCC and one metastatic melanoma patient had a pathologic non-response (< 50% clearance). Patients with a pathologic complete response (100% tumor clearance) may have visual signs of residual scar or subdermal inflammation prior to resection. No patients, however, exhibited clinical progression of disease.

To date, there were no dose-limiting toxicities or clinically relevant treatment-emergent adverse effects in the patients receiving intratumoral PH-762 in this trial. Moreover, PH-762 has been well tolerated in all enrolled patients in each escalating dose cohort.

The fourth cohort is currently enrolling and treating patients; Phio expects to complete enrollment in the trial in the third quarter of 2025.

Scientific News

During the three months ended March 31, 2025, Phio was awarded podium presentations for its INTASYL self-delivering siRNA technology at the American Academy of Dermatology (AAD) and at the Society of Investigative Dermatology (SID). The Company presented its phase 1b clinical trial results to date. The Company also presented data on INTASYL compounds PH-762 and PH-894 at the 11th Annual Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (ITOC 11) conference in Munich, Germany.

The Company’s INTASYL compound RXI-231 was highlighted in the peer reviewed journal, Clinical, Cosmetic and Investigational Dermatology. The article presented proof-of-concept data for RXI-231, an INTASYL compound designed to target and reduce tyrosinase (TYR) gene expression. While further characterization and clinical testing is needed, RXI-231 shows promise in treating hyperpigmentation disorders.

Capital Sourcing

In December 2024 and January 2025, Phio raised an aggregate of approximately $9.2 million in registered direct offerings and concurrent private placements, before deduction of commissions and other expenses. Additional gross proceeds of approximately $2.9 million were raised from the exercise of warrants previously issued on July 12, 2024. With these proceeds, the Company now believes it has sufficient capital to complete the treatment phase of the Phase 1b trial.

Cost Rationalization

From April 2014 to March 2024, the Company leased space that was utilized as its corporate headquarters and primary laboratory. The lease expired on March 31, 2024. On March 1, 2024, the Company commenced a lease for a laboratory facility located at 17 Briden Street, Worcester, Massachusetts. The lease had an original expiration date of August 31, 2024, and was subsequently extended through February 28, 2025. The Company continues to lease the space on a month-to-month basis. Monthly rent is approximately $2,500. In March 2025, the Company contracted with LifeSciences PA located at 411 Swedeland Road, King of Prussia, PA 19406 for access to full working space for normal hours of operations at a fee of $300 per month, which can be cancelled at any time.

In May 2024, the Company terminated the Clinical Co-Development Agreement with AgonOx, Inc. (AgonOx) effective immediately. The Company paid AgonOx all payment obligations that accrued prior to the termination of the Clinical Co-Development Agreement. The Company made the remaining payment of $34,320, which primarily related to accrued obligations for patient fees and other miscellaneous costs as of the date of termination to AgonOx on March 21, 2025. This settled all future obligations to AgonOx.

Financial Results

Cash Position

At March 31, 2025, the Company had cash of approximately $13.3 million as compared with approximately $5.4 million at December 31, 2024.

Net cash provided by financing activities for the three months ended March 31, 2025 was approximately $9.2 million as compared to the three months ended March 31, 2024 where net cash used in financing activities was approximately $4,000. The increase in net cash provided by financing activities was primarily due to the issuance of common stock and warrants, and the exercise of warrants.

Research and Development Expenses

Research and development expenses were $0.886 million for the three months ended March 31, 2025 as compared with $1.148 million for the three months ended March 31, 2024, a decrease of 23%. The decrease in research and development expenses was primarily driven by decreases in salary-related costs and in consulting expense.

General and Administrative Expenses

General and administrative expenses were approximately $0.986 million for the three month period ended March 31, 2025 as compared with approximately $1.061 million for the three months ended March 31, 2024, a decrease of 7%. The Company considers this to be an immaterial fluctuation.

Net Loss

Net loss was $1.8 million for the three months ended March 31, 2025 as compared with $2.2 million for the three months ended March 31, 2024. The decrease in net loss was due to the reductions in research and development and general and administrative expenses cited above.

On May 15, 2025 Orna Therapeutics, a leading biotechnology company developing a proprietary pipeline of in vivo therapies across a broad range of autoimmune and oncology indications, reported the presentation of new preclinical data supporting its in vivo CAR therapy approach in autoimmune diseases during an oral session at the 28th American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting being held May 13-17, 2025, in New Orleans, Louisiana (Press release, Orna Therapeutics, MAY 15, 2025, View Source [SID1234653178]).

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"The preclinical data presented today at ASGCT (Free ASGCT Whitepaper) highlight our potential to deliver on the promise of in vivo CAR T therapy," said Joseph Bolen, Ph.D., Chief Executive Officer of Orna Therapeutics. "Our CD19 panCAR program has demonstrated not only successful delivery of our lead panCAR LNP to disease-relevant immune cell types, but also robust and sustained B cell depletion at low doses in both peripheral blood and lymphoid tissues in non-human primates (NHPs). These compelling results continue to reinforce our commitment to translating our promising science into meaningful therapies for patients and we look forward to advancing our CD19 panCAR program towards the clinic in 2026."

Presentation Details:

Title: In Vivo panCAR Therapy Using Circular RNA for the Treatment of Autoimmune Disease

Speaker: Megan Hoban, Ph.D., panCAR Program Lead, Orna Therapeutics

Date/Time: Thursday, May 15, 2025, 8:00 AM – 9:45 AM CDT

Session Name: Cellular and Gene Therapies for Autoimmune Disease

Location: Room 388-390

In today’s presentation, Orna will showcase preclinical data demonstrating the potential of its in vivo panCAR therapy, enabled by its proprietary circular (oRNA) technology and best-in-class lipid nanoparticle (LNP) delivery system to achieve robust and sustained B cell depletion in both humanized mouse models and non-human primates across multiple doses.

Key findings from the study include:

Validated extra-hepatic delivery to disease-relevant immune cell types, including T cells, in mice and NHPs without requiring targeting ligands.
Lead panCAR LNP achieved over 60% delivery to peripheral blood and splenic T cells in NHPs.
CD19 panCAR doses as low as 0.03mpk led robust B cell depletion, with multi-dosing achieving increased B cell depletion in humanized mice.
In a humanized lupus mouse model, CD19 panCAR showed strong B cell depletion and a meaningful and differentiated reduction in dsDNA titers compared to rituximab.
CD19 panCAR induced full depletion of B cells across peripheral blood, spleen, lymph nodes, and bone marrow in NHPs, with peripheral B cells beginning to reconstitute after three weeks.

On May 15, 2025 Omeros Corporation (Nasdaq: OMER) reported recent highlights and developments as well as financial results for the first quarter ended March 31, 2025, which include (Press release, Omeros, MAY 15, 2025, View Source [SID1234653177]):

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● Net loss for the first quarter of 2025 was $33.5 million, or $0.58 per share, compared to a net loss of $37.2 million, or $0.63 per share for the first quarter of 2024.

● At March 31, 2025, we had $52.4 million of cash and short-term investments available for operations and debt servicing, a decrease of $37.7 million from December 31, 2024.

● In March 2025, we resubmitted to the U.S. Food and Drug Administration ("FDA") our Biologics License Application ("BLA") seeking regulatory approval for narsoplimab in hematopoietic stem cell transplant-associated thrombotic microangiopathy ("TA-TMA"). FDA accepted the resubmission for review as a class 2 resubmission and, pursuant to the Prescription Drug User Fee Act ("PDUFA"), assigned a target date for FDA action of September 25, 2025.

● We are also preparing a European marketing authorization application ("MAA") for narsoplimab in TA-TMA, which we expect to submit in the second quarter of 2025.

● On May 12, 2025, we entered into exchange agreements with holders of our 5.25% Convertible Senior Notes due 2026 (the "2026 Convertible Notes"). We exchanged $70.8 million in aggregate principal amount of our 2026 Convertible Notes for newly issued 9.50% Convertible Senior Notes due in June 2029, on a one-for-one basis. In addition, we reached an agreement with two affiliated holders to convert $10.0 million in aggregate principal amount of the 2026 Convertible Notes into shares of our common stock in three separate tranches, with the conversion of the entire principal to be completed no later than September 15, 2025. Following these transactions, the outstanding principal balance of the 2026 Convertible Notes will be reduced to approximately $17.1 million. Significantly, the reduction in the principal amount of our 2026 Convertible Notes eliminated the need to avoid an accelerated maturity of the entire balance of our term loan by making a $20.0 million prepayment and paying a $1.0 million prepayment premium on or prior to November 2025.

● During the first quarter we elected to temporarily suspend or pause certain activities and programs to prioritize the allocation of our currently available capital to the development of commercial infrastructure and capacities needed to ensure the successful launch of narsoplimab, assuming approval by FDA of our BLA, and to the completion of our ongoing clinical trials with enrolled patients.

● Last quarter we began initiating clinical trial sites for our Phase 3 program evaluating zaltenibart (formerly known as OMS906) for the treatment of paroxysmal nocturnal hemoglobinuria ("PNH"); however, based on the anticipated ramp up in spending on those trials and the need to prioritize the use of currently available capital, we determined to pause our Phase 3 PNH program temporarily. We are working with our vendors and investigators to ensure that the program is ready to be restarted with as little disruption to the timeline as possible after securing capital. We expect to complete remaining activities in our ongoing clinical trial evaluating zaltenibart for the treatment of PNH in treatment-naïve patients and to continue the long-term extension study, which enrolls zaltenibart-treated PNH patients who have completed any of our prior zaltenibart studies.

● Although preparations for the anticipated commercial launch of narsoplimab will continue, we have determined to suspend our expanded access program ("EAP") for narsoplimab, also known as compassionate use, to eliminate direct costs associated with drug supply and external management of the EAP program. We remain committed to supporting patients who are currently being treated under the EAP and discontinuation of the EAP will not affect these patients. Additionally, our ongoing study of narsoplimab in pediatric patients with TA-TMA will continue.

● Development spending on our long-acting, next generation MASP-2 inhibitor, OMS1029 has already been limited. That asset is Phase 2 ready, with drug product needed to support Phase 2 trials having been manufactured and stored, pending the selection of the first indication and the availability and allocation of resources to initiate Phase 2 studies.

● Spending in other areas of our complement programs, including our small-molecule MASP-2 and MASP-3 programs, is also being reduced or halted as part of our effort to focus resources on core development priorities.

"We are pleased that our BLA for narsoplimab in TA-TMA has been accepted by FDA, which is a significant milestone for our narsoplimab program and for Omeros," said Gregory A. Demopulos, M.D., Omeros’ Chairman and Chief Executive Officer. "We have already received and are responding to FDA’s information requests, and our highest priority as an organization is to obtain approval for narsoplimab. For this reason, we have taken action to reduce expenses and prioritize spending on the narsoplimab launch and other key priorities. In parallel, through the recently completed exchange of the large majority of our 2026 convertible notes for convertible notes maturing in 2029 and converting a small portion to equity, our total debt will be reduced by approximately $10.0 million and our near-term debt maturities will be lowered by over $100 million, reducing our short-term debt repayment obligations from approximately $118 million to approximately $17 million. This should position us well to raise additional capital for our operations."

First Quarter and Recent Clinical Developments

● Recent developments regarding OMS527, our phosphodiesterase 7 ("PDE7") inhibitor program focused on addictions and compulsive disorders as well as movement disorders, include:

● Work on the planned randomized, double-blind, parallel-group, inpatient Phase 1b clinical trial comparing the safety and efficacy of OMS527 to placebo in the treatment of adults with cocaine use disorder ("CUD") is ongoing with committed funding from the National Institute on Drug Abuse, a part of the National Institutes of Health, in the amount of $4.02 million for the year commencing April 1, 2025. Enrollment in the study is expected to begin later this year and a readout of data from the study is anticipated late this year or in early 2026.

● Recent developments regarding our oncology platform comprising signaling-driven immunomodulators, oncotoxins, and an adoptive T-cell technology combined with an immunostimulator, include:

● In April 2025, we established the Omeros Oncology Clinical Steering Committee to advance Omeros’ OncotoX biologics program focused on acute myeloid leukemia ("AML"). The clinical steering committee is composed of leaders in AML treatment and research at the premier cancer centers across the United States. These experts in the treatment of AML are expected to help guide clinical development of our potential AML therapeutic.

● We continue on a limited basis to progress pre-clinical studies within our novel oncology program, including IND-enabling studies in our OncotoX-AML program. In both in vivo and in vitro models with human cell lines, our OncotoX-AML therapeutic has consistently demonstrated superior efficacy to current AML standard of care treatments. OncotoX-AML shows broad application across AML regardless of genetic mutation including TP53, NPM1, KMT2a, and FLT3. IND-enabling work is ongoing with an estimated timeline to clinical entry of 18-24 months.

Financial Results

Net loss for the first quarter of 2025 was $33.5 million, or $0.58 per share, compared to a net loss of $37.2 million, or $0.63 per share for the first quarter of 2024.

At March 31, 2025, we had $52.4 million of cash and short-term investments available for operations and debt service, a decrease of $37.7 million from December 31, 2024.

For the first quarter of 2025, we earned OMIDRIA royalties of $6.7 million on Rayner’s U.S. net sales of $22.3 million. This compares to earned OMIDRIA royalties of $9.4 million during the first quarter of 2024 on U.S. net sales of $31.2 million. Per the terms of our original 2022 and amended 2024 agreements with DRI Health Acquisition LP, ("DRI"), all U.S. based royalties through 2031 are remitted from Rayner to DRI through an escrow agent.

Total operating expenses for the first quarter of 2025 were $35.0 million compared to $39.0 million for the first quarter of 2024. The $4.1 million decrease was primarily due to the wind down of our clinical program developing narsoplimab for IgA nephropathy offset by increased clinical development costs with Phase 2 of our zaltenibart program.

Interest expense during the first quarter of 2025 was $3.7 million compared to $8.2 million during the prior year quarter. The decrease was due to repurchasing and retiring $118.1 million of par on our 2026 Notes in June 2024 and recording a non-cash remeasurement adjustment in the prior year to increase the OMIDRIA royalty obligation to reflect the sale of expanded royalties to DRI.

During the first quarter of 2025, we earned $1.1 million in interest and other income compared to $3.4 million in the first quarter of 2024. The difference is primarily due to lower cash and investments available to invest in the current quarter.

Net income from discontinued operations, net of tax, was $4.1 million, or $0.07 per share, in the first quarter of 2025 compared to $6.7 million, or $0.11 per share, in the first quarter of 2024. The decrease was primarily attributable to a decrease in OMIDRIA royalties earned in the current quarter.

Conference Call Details

Omeros’ management will host a conference call and webcast to discuss the financial results and to provide an update on business activities. The call will be held today at 1:30 p.m. Pacific Time; 4:30 p.m. Eastern Time.

For online access to the live webcast of the conference call, go to Omeros’ website at View Source

To access the live conference call via phone, participants must register at the following URL View Source to receive a unique PIN. Once registered, you will have two options: (1) Dial in to the conference line provided at the registration site using the PIN provided to you, or (2) choose the "Call Me" option, which will instantly dial the phone number you provide. Should you lose your PIN or registration confirmation email, simply re-register to receive a new PIN.

A replay of the call will be made accessible online at View Source

On May 15, 2025 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics ("Molecular Partners" or the "Company"), reported corporate highlights and unaudited financial results for the first quarter of 2025 (Press release, Molecular Partners, MAY 15, 2025, View Source [SID1234653176]).

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"Molecular Partners is on track to reach key clinical milestones in 2025. In January, we expanded our strategic radiotherapy partnership with Orano Med and are continuing to advance the lead program, MP0712, towards a first-in-human trial. With the data package of MP0712 complete, we anticipate both the IND filing and initial clinical data on MP0712 in 2025. The early images and dosimetry data will be a strong surrogate for the expected efficacy and safety in Phase 1. Our multispecific T cell engager MP0533 is progressing in its Phase 1/2a trial in acute myeloid leukemia. Initial data from cohort 8, with an additional dosing point in the step-up dosing, indicate increased rates and depth of responses, while the fully amended dosing scheme is being tested in cohort 9. Our focus remains firmly on delivering results that further validate our science and create meaningful value for patients and stakeholders alike, based on a solid financial position with funding in place well into 2027," said Patrick Amstutz, Ph.D., CEO of Molecular Partners.

Research & Development Highlights

MP0712, Radio-DARPin Pipeline and Global Partnership with Orano Med

In January 2025, Molecular Partners and Orano Med further expanded their agreement to co-develop up to ten 212Pb-labeled radiotherapy programs. Molecular Partners holds commercialization rights to MP0712, a Radio-DARPin therapy (RDT) candidate targeting delta-like ligand 3 (DLL3) for the treatment of small cell lung cancer (SCLC), and to the second program, targeting mesothelin (MSLN). In addition to its world class expertise and capabilities in the development of targeted alpha therapy (TAT) with 212Pb, Orano Med will ensure the production of the 212Pb-based Radio-DARPins for clinical trials and commercialization.

Molecular Partners presented preclinical data in April at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025, showing high tumor uptake and a favorable toxicity profile for MP0712, with good efficacy and tumor reduction in mouse models matching clinically relevant DLL3 expression levels. With these data, the Investigational New Drug (IND)-enabling package is complete.

The IND application for MP0712 is planned for mid 2025 and dialogue with the U.S. Food and Drug Administration (FDA) is ongoing. Based upon discussion with the agency the Company has determined that a Phase 0 imaging study, which was previously planned, will not be necessary. MP0712 will proceed directly to a Phase 1 dose-escalation study utilizing 212Pb, which includes an imaging step using 203Pb. This study will initiate in the second half of 2025, pending IND submission and clearance.

In addition, Molecular Partners has received and accepted a request from Nuclear Medicine Research Infrastructure (NuMeRI) in South Africa to provide MP0712 for imaging use under the legal framework in South Africa for compassionate care (also referred to as Section 21 of the Medicines and Related Substances Act). This approach enables the generation of first images applying MP0712 labelled with 203Pb in patients with SCLC. While the decision of where and how to share data from the image work under Section 21 remains at the discretion of NuMeRI, the Company anticipates providing an update on MP0712 in H2 2025.

The second RDT program co-developed with Orano Med targets MSLN, a tumor target overexpressed across several cancers with high unmet need, such as ovarian cancer. The development of therapeutics against MSLN has been hampered by high shedding of MSLN, leading to high levels of soluble MSLN. Leveraging the unique properties of DARPins, Molecular Partners has developed Radio-DARPins able to selectively bind to membrane-bound MSLN without being impacted by shed MSLN. First preclinical data from the MSLN program were presented at AACR (Free AACR Whitepaper) 2025, with in vivo results showing a favorable biodistribution with strong tumor accumulation of the Radio-DARPin in a MSLN-overexpressing model in mice. Molecular Partners will present more preclinical data on the MSLN program in an oral presentation at the 2025 Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting in June.

MP0533 (Multispecific T Cell Engager)

MP0533 is currently being evaluated in a Phase 1/2a clinical trial for relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome/AML (ClinicalTrials.gov: NCT05673057). Dose escalation in cohorts 1–7 showed an acceptable safety profile and initial activity, yet with unsustained responses (four responders reported and encouraging blast reductions across additional patients).

In the ongoing cohort 8, an additional dosing timepoint was introduced to allow steeper step-up and more frequent dosing to reach the MP0533 target dose faster. Data from this cohort indicate increased rates and depth of responses, with three out of eight evaluable patients demonstrating responses (data cutoff 16 December 2024). The Company will present additional data on Cohort 8 at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress in June 2025.

The study protocol has been amended to improve the exposure profile of MP0533 based on the learnings from the dose escalation cohorts, and has been approved by regulatory authorities in April 2025. It foresees further MP0533 dose densification and premedication to mitigate loss of exposure, with the objective to further increase the rate, depth and duration of responses observed in cohort 8. Enrollment has started and data on the amended dosing scheme are expected in 2025.

Switch-DARPin Platform (Next-generation Immune Cell Engagers)

By employing a multi-specific Switch-DARPin, Molecular Partners aims to increase the safety and potency of T cell engagers (TCEs). Preclinical proof-of-concept in a solid tumor model for a novel CD3 Switch-DARPin TCE was presented at AACR (Free AACR Whitepaper) 2025.The CD3 Switch-DARPin activates T cells specifically in the presence of cells co-expressing MSLN and epithelial cell adhesion molecule (EpCAM), increasing tumor specificity. The data presented provide further validation of Switch-DARPins and show that conditional T-cell activation with potent CD2 co-stimulation in solid tumors, but not in healthy tissues, is feasible.

Molecular Partners’ first Switch-DARPin program, MP0621, is designed to induce killing of hematopoietic stem cells (HSCs) as a next-generation conditioning regimen for HSC transplantation. The Company has presented pre-clinical proof-of-mechanism data on MP0621 in 2024. As its portfolio strategy prioritizes therapeutic candidates for oncology, MP0621 is being evaluated for partnering.

MP0317 (localized agonist)

Molecular Partners presented comprehensive biomarker analyses from the completed Phase 1 dose escalation trial of the localized CD40 agonist MP0317 in solid tumors at SITC (Free SITC Whitepaper) in November 2024. MP0317 is designed to activate immune cells specifically within the tumor microenvironment by anchoring to fibroblast activation protein (FAP), which is expressed in high amounts in the stroma of various solid tumors. The Company believes this tumor-localized approach has the potential to deliver greater efficacy with fewer side effects compared to systemic CD40-targeting therapies.

Molecular Partners is in discussion with leading academic centers regarding potential investigator-initiated trials of MP0317 in 2025, in combination with immune checkpoint inhibitors and additional standard of care for patients with solid tumors.

Corporate Governance Highlights

All motions proposed by the Board of Directors at the Annual General Meeting, held in April 2025, were approved by the shareholders of the Company.

Financial and Business Outlook
For the full year 2025, at constant exchange rates, the Company expects total operating expenses of CHF 55-65 million of which around CHF 7 million will be non-cash effective costs for share-based payments, IFRS pension accounting and depreciation.

The Company’s cash and cash equivalents and short-term time deposits were CHF 131 million as of March 31, 2025 and based on current operating assumptions, will be sufficient to fund its operating expenses and capital expenditure requirements well into 2027.

On May 15, 2025 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, reported a business update and announced financial results for the first quarter ended March 31, 2025 (Press release, Mersana Therapeutics, MAY 15, 2025, View Source [SID1234653175]).

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"Given recent positive front-line data reported from topo-1 ADC registrational trials, we believe the post-topo-1 breast cancer patient population is poised to expand significantly. Our initial aim is to develop Emi-Le to serve this high unmet need population," said Martin Huber, M.D., President and Chief Executive Officer of Mersana Therapeutics. "To that end, we were pleased to present encouraging preliminary progression free survival and overall survival data for Emi-Le among patients with post-topo-1 TNBC today at ESMO (Free ESMO Whitepaper) Breast Cancer 2025. Additionally, our team has made considerable progress enrolling these patients in our dose expansion cohorts thus far in 2025, putting us on track for an initial expansion data readout later this year."

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 (Free ESMO Whitepaper) 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.

The presentation included clinical activity data among evaluable patients (those with measurable disease at baseline and at least one post-baseline scan) across all tumor types (TNBC, hormone-receptor-positive, human epidermal growth factor receptor 2 (HER2) negative breast cancer; ovarian cancer; endometrial cancer and adenoid cystic carcinoma type 1) with B7-H4 high tumor expression (defined as a tumor proportion score of 70% or higher) who received intermediate Emi-Le doses of 38.1 milligrams per meter squared (mg/m2) to 67.4 mg/m2 per cycle. For these patients, the confirmed objective response rate (ORR) was 31% (8 of 26 patients). This is an increase from the 23% ORR (6 of 26 patients) previously reported based upon a December 13, 2024 data cutoff.

The primary focus of the presentation was on TNBC patients enrolled in dose escalation and backfill cohorts. Safety and tolerability data from these patients were consistent with previously reported data with no new safety signals. Among evaluable patients with TNBC who received intermediate Emi-Le doses, ORR, preliminary progression free survival (PFS) and preliminary overall survival (OS) data include the following:

Patients with B7-H4 high
TNBC receiving ≤4 prior
treatment lines in advanced/
metastatic setting (n=7)* Patients with B7-H4 low
TNBC receiving ≤4 prior
treatment lines in advanced/
metastatic setting (n=11)
Received ≥1 Prior Topo-1 ADC 100% (7/7) 73% (8/11)
ORR 29% (2/7) 0% (0/11)
Median PFS 16.0 weeks 6.4 weeks
Median OS Not reached 5.7 months
* Mersana’s ongoing expansion cohorts are enrolling TNBC patients who have received 1 to 4 prior lines of treatment, including at least one topo-1 ADC, with a primary focus on patients with B7-H4 high tumor expression

In the ASCENT Phase 3 clinical trial of sacituzumab govitecan, a topo-1 ADC, the ORR, median PFS and median OS for the standard-of-care single-agent chemotherapy control arm in topo-naïve relapsed/refractory TNBC were approximately 5%, 7 weeks and 7 months, respectively.

"The performance of today’s standard of care for patients with TNBC who have previously been treated with a topo-1 ADC is poor," said Erika Hamilton, M.D., Director Breast Cancer Research, Sarah Cannon Research Institute in Nashville, Tennessee, who presented these data at ESMO (Free ESMO Whitepaper) Breast Cancer 2025. "In light of this significant unmet medical need and research indicating that B7-H4 tumor expression is a negative prognostic factor, the data presented today are promising. I am looking forward to Emi-Le’s continued development."

The ESMO (Free ESMO Whitepaper) Breast Cancer 2025 presentation can be accessed on the Publications section of the Mersana website at www.mersana.com.

Expansion Update: Mersana continues to advance the dose expansion portion of its Phase 1 clinical trial of Emi-Le in patients with TNBC who have received one to four prior lines of therapy, including at least one topo-1 ADC. In recent months, the company has made significant progress in the enrollment of patients in its "Dose A" cohort, in which patients are receiving 67.4 mg/m2 of Emi-Le every four weeks (Q4W).

Mersana also recently initiated enrollment in its "Dose B" cohort. These patients are receiving a starting dose of 44.5 mg/m2 of Emi-Le on days 1 and 8 of the first four-week cycle followed by 80 mg/m2 of Emi-Le Q4W.

The company plans to report initial clinical data from the expansion portion of its Phase 1 clinical trial in the second half of 2025.

Upcoming ASCO (Free ASCO Whitepaper) Presentation: There will be two presentations regarding Emi-Le at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 Annual Meeting taking place May 30-June 3, 2025 at McCormick Place, Chicago, IL. The first is an oral presentation that includes clinical data from the company’s Phase 1 dose escalation and backfill cohorts across all enrolled tumor types based upon a March 8, 2025 data cutoff. The second is a trial-in-progress poster presentation discussing the ongoing expansion portion of Mersana’s Phase 1 clinical trial of Emi-Le.

XMT-2056
The dose escalation portion of Mersana’s Phase 1 clinical trial of XMT-2056, the company’s lead Immunosynthen ADC candidate targeting a novel HER2 epitope, is ongoing. 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 support its collaborations with both Johnson & Johnson (Dolasynthen research collaboration) and Merck KGaA, Darmstadt, Germany (Immunosynthen research collaboration).

First Quarter 2025 Financial Results

Cash and cash equivalents as of March 31, 2025 were $102.3 million. Due in part to the strategic restructuring and reprioritization plan that was announced on May 6, 2025, Mersana expects that its capital resources will be sufficient to support its current operating plan commitments into mid-2026.
Net cash used in operating activities for the first quarter of 2025 was $29.3 million.
Collaboration revenue for the first quarter of 2025 was $2.8 million, compared to $9.2 million for the same period in 2024. The year-over-year change was primarily related to reduced revenue recognized under the company’s collaboration and license agreements with Johnson & Johnson and Merck KGaA, Darmstadt, Germany, partially offset by increased revenue recognized under its agreement with GSK.
Research and development (R&D) expense for the first quarter of 2025 was $18.3 million, compared to $18.7 million for the same period in 2024. Included in the first quarter of 2025 R&D expense was $1.4 million in non-cash stock-based compensation expense. The year-over-year change in R&D expense was primarily related to lower headcount and related employee compensation costs, partially offset by an increase in costs related to clinical development activities for Emi-Le.
General and administrative (G&A) expense for the first quarter of 2025 was $8.9 million, compared to $11.6 million during the same period in 2024. Included in the first quarter of 2025 G&A expense was $1.3 million in non-cash stock-based compensation expenses. The year-over-year change in G&A expense was primarily related to a reduction in consulting and professional services fees as well as the company’s lower headcount and related employee compensation costs.
Net loss for the first quarter of 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.
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 2025. 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.