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.

On May 15, 2025 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that the Phase 3 KEYNOTE-B96 trial, also known as ENGOT-ov65, met its primary endpoint of progression-free survival (PFS) for the treatment of patients with platinum-resistant recurrent ovarian cancer whose tumors expressed PD-L1 and in all comers (Press release, Merck & Co, MAY 15, 2025, View Source [SID1234653174]). The study also met a secondary endpoint of overall survival (OS) in patients whose tumors express PD-L1. The study is evaluating KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with chemotherapy (paclitaxel) with or without bevacizumab for these patients. The trial is continuing and OS for the full study population will be evaluated at a future analysis.

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At pre-specified interim analyses conducted by an independent Data Monitoring Committee, the KEYTRUDA-based regimen demonstrated a statistically significant and clinically meaningful improvement in PFS regardless of PD-L1 status compared to placebo plus chemotherapy with or without bevacizumab. The study also showed a statistically significant and clinically meaningful improvement in OS in patients whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1) compared to placebo plus chemotherapy with or without bevacizumab. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies; no new safety signals were identified. Results will be presented at an upcoming medical meeting and shared with regulatory authorities worldwide.

"This marks the first time a KEYTRUDA-based regimen has shown the ability to help certain patients with platinum-resistant ovarian cancer live longer, and the first time an immune checkpoint inhibitor-based regimen has demonstrated an overall survival benefit in ovarian cancer," said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. "The positive results from this trial add to the growing body of evidence supporting the potential benefit of KEYTRUDA across gynecological cancers, including this difficult-to-treat form of ovarian cancer for which patients are in need of new options."

KEYTRUDA is not approved to treat ovarian cancer (see selected KEYTRUDA indications in the U.S. below). LYNPARZA (olaparib), which is being jointly developed and commercialized by AstraZeneca and Merck, has three approved ovarian cancer indications in the U.S.: in first-line maintenance treatment of BRCA-mutated advanced ovarian cancer, following complete or partial response to first-line platinum-based chemotherapy; in first-line maintenance treatment of HRD-positive advanced ovarian cancer in combination with bevacizumab, following complete or partial response to first-line platinum-based chemotherapy; and in maintenance treatment of BRCA-mutated recurrent ovarian cancer, following complete or partial response to platinum-based chemotherapy. For each of these indications, patients are selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA (see indications for LYNPARZA below). In 2024, Merck announced the initiation of the Phase 2/3 REJOICE-Ovarian01 trial evaluating raludotatug deruxtecan (R-DXd), an investigational potential first-in-class CDH6 directed DXd antibody-drug conjugate discovered by Daiichi Sankyo and being jointly developed with Merck, in patients with platinum-resistant ovarian cancer.

About KEYNOTE-B96/ENGOT-ov65

KEYNOTE-B96, also known as ENGOT-ov65, is a randomized, double-blind Phase 3 trial (ClinicalTrials.gov, NCT05116189) sponsored by Merck and conducted in collaboration with the European Network for Gynecologic Oncology Trial (ENGOT) groups investigating KEYTRUDA in combination with chemotherapy (paclitaxel) with or without bevacizumab compared to placebo plus chemotherapy with or without bevacizumab for the treatment of platinum-resistant recurrent ovarian cancer. The primary endpoint is PFS, and OS is a key secondary endpoint. The trial enrolled an estimated 643 patients who were randomized to receive:

KEYTRUDA (400 mg intravenously every six weeks for approximately two years) plus paclitaxel with or without bevacizumab, or;
placebo plus paclitaxel with or without bevacizumab.
About ovarian cancer

Ovarian cancer often begins in the fallopian tubes or on the outer surface of the ovaries. It is the third most common gynecologic malignancy and seventh most common cancer in women worldwide. Globally, there were approximately 324,603 patients diagnosed with ovarian cancer and about 206,956 deaths from the disease in 2022. In the U.S., it is estimated there will be approximately 20,890 patients diagnosed with ovarian cancer and about 12,730 deaths from the disease in 2025. The primary aim of first-line treatment is to delay disease progression for as long as possible with the intent to achieve long-term remission.

On May 15, 2025 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage biopharmaceutical company leveraging its proprietary RADR artificial intelligence (AI) and machine learning (ML) platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported operational highlights and financial results for the first quarter 2025 ended March 31, 2025, and provided an update on its portfolio of AI-driven drug candidates, the RADR platform for precision oncology drug development enhancements, and other operational progress (Press release, Lantern Pharma, MAY 15, 2025, View Source [SID1234653173]).

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AI-Powered Drug Development Pipeline Highlights:

LP-300

Lantern’s Phase 2 HARMONIC trial for LP-300 continued to advance during Q1 2025 with patients enrolled in Japan and Taiwan and ongoing enrollment in the US. Never-smokers with NSCLC in East Asia represent approximately 33% to 40% of new NSCLC cases as compared to the U.S., where never smokers account for approximately 15% of new NSCLC cases. LP-300 is being evaluated in combination with standard-of-care chemotherapy (carboplatin + pemetrexed) in never-smokers with NSCLC adenocarcinoma who have progressed after TKI therapy. The trial is designed to enroll approximately 90 patients across the U.S. and East Asia.

Phase 2 Clinical Results: Preliminary data from the Phase 2 U.S. safety, lead-in cohort showed an 86% clinical benefit rate and a 43% objective response rate. Additional patient data from the expansion cohort continues to support, at the current time, a similar patient response and clinical benefit rate trend. Lantern plans on sharing additional results, which will include updated data from patients enrolled in the lead-in cohort and new data from patients in the Asian expansion cohort, during Q3 of 2025.

LP-184

LP-184 continued advancements through a Phase 1a trial in multiple solid tumors, which is targeted to finish enrollment during June of 2025. LP-184 has received Fast Track Designations from the FDA for GBM (Glioblastoma Multiforme) and TNBC (Triple Negative Breast Cancer). Additionally, LP-184 has four Rare Pediatric Disease Designations for hepatoblastoma, rhabdomyosarcoma, and malignant rhabdoid tumors, and ATRT (atypical teratoid, rhabdoid tumors).

Phase 1a Results: Safety, Tolerability, Pharmacokinetics including MTD Determination – The trial has now enrolled through cohort 12, and early indications of clinical activity have been observed at higher dose levels, consistent with preliminary PK data. During Q1 2025, the Safety Review Committee (SRC) along with the Company, made the decision to backfill dose levels 10 and 11 to ensure clarity on the maximum tolerated dose (MTD) while ensuring the safety of study participants, and assessing the clinical activity of the dose to guide future LP-184 clinical trials. Enrollment at dose level 9 and higher has been focused on inclusion of advanced solid tumor patients that have identified DNA damage repair mutations. A broader clinical data update is slated for Q3 of 2025, when complete safety, pharmacokinetic and dose response data along with biomarker correlations is expected to be available.

Future Planned Phase 1b/2 Trials: Lantern has recently cleared two clinical trial protocols with the FDA that can provide a path towards a regulatory approval.

The first, announced on May 5th, is for a Phase 1b/2 study in TNBC evaluating LP-184 in both a combination regimen with the PARP inhibitor, Olaparib and as monotherapy in the same indication. The FDA has raised no objections to the protocol, and Lantern plans to initiate this trial in both the US and at leading academic cancer centers in Nigeria and India, subject to clinical priorities and funding. The average survival for newly diagnosed, metastatic TNBC is estimated at 8 to 13 months and presents an annual market opportunity in excess of $4 billion USD.

The second, announced on May 12th, is for a Phase1b/2 study in a biomarker defined subset of drug-resistant non-small cell lung cancer that has mutations in the STK11 and/or KEAP1 genes. This unique trial is aimed at addressing a critical unmet clinical need in lung cancer care: the median overall survival in newly diagnosed, advanced NSCLC patients with KEAP1 and/or STK11 mutations treated with chemo-immunotherapy averages 15 months, substantially lower than outcomes in mutation negative populations. For patients that fail earlier lines of therapies the overall survival tends to skew even lower at approximately 6.3 months. This represents a market opportunity exceeding $2 billion annually, given the prevalence and poor prognosis for patients with these mutations.

Additionally, an investigator-led, exploratory clinical trial of LP-184 for recurrent bladder cancer is planned to begin in Denmark during Q3 of 2025. This clinical trial is designed to test LP-184 as a monotherapy specifically in advanced, recurrent bladder cancer patients with DNA damage repair mutations with the potential to create a path towards data to support usage in the 3rd line setting.

RADR A.I. Platform:

Lantern’s proprietary RADR platform has grown during Q1 2025 to approximately 200 billion oncology-focused data points across multiple sources (proprietary, collaborative and public) of oncology, molecular, clinical, biochemical, and preclinical datasets.

RADR continues to play an important role in advancing:

● drug candidate optimization,
● development and validation of clinically relevant drug-candidate combinations,
● identification of mechanism(s) of action,
● identification of optimal indications for drug-candidate advancement,
● creation of biomarker signatures to support patient selection,
● optimization and characterization of molecular features, and
● prediction of the blood brain barrier (BBB) potential of a molecule.

AI and platform-driven insights contributed to LP-184’s clinical biomarker strategy, including a qPCR assay for PTGR1 to guide patient stratification, and aided in the identification of multiple indications leading to orphan and rare pediatric disease designations. Additionally, RADR also underpinned combination strategies, such as LP-184 with PARP inhibitors and LP-284 with rituximab. Future plans and proposed developments include additional collaborations with leading oncology development groups and biopharma companies in both adult and pediatric cancers. Lantern expects to publicly release multiple modules (validated A.I. frameworks) that can be accessed by Lantern collaborators and the research community for specific needs in oncology drug development—such as prediction of certain molecular features including the BBB penetrability of a molecule, identification of potential cancer indications that are more likely to show a higher sensitivity to a molecule or drug-candidate, and aiding the development of optimized paths to demonstrate potential therapeutic utility of a molecule in a rare cancer.

Starlight Therapeutics:

Lantern’s wholly owned subsidiary focused on CNS and brain cancers, Starlight Therapeutics, made key advances towards the design, development and approval of adult and pediatric trials, including potential investigator-initiated clinical trials for STAR-001. LP-184, referred to as STAR-001 for CNS indications, was highlighted at the Society for Neuro-Oncology (SNO) 2024 conference, with a Phase 1b/2 trial in recurrent GBM anticipated to begin in late 2025 subject to successful additional funding and clearance of the protocol. Additionally, further preclinical studies led by Lantern’s collaborators at Johns Hopkins provided independent confirmation of LP-184 hypersensitivity in rare pediatric brain tumors, in support of a clinical trial being planned with a pediatric consortium in CNS tumors.

Additional Operational Highlights:

Lantern also advanced a proprietary BBB permeability prediction algorithm with a favorable PCT patent application report, advancing our AI leadership with Lantern’s algorithms now holding five of the top ten positions on Therapeutic Data Commons (TDC) Leaderboard. The company is developing a publicly available tool to predict the BBB permeability of any molecule that can be readily accessed by the research and drug development community, which is planned for initial launch during the second half of 2025.

First Quarter 2025 Financial Highlights:

➢ Balance Sheet: Cash, cash equivalents, and marketable securities were approximately $19.7 million as of March 31, 2025, compared to approximately $24.0 million as of December 31, 2024.

➢ R&D Expenses: Research and development expenses were approximately $3.3 million for the quarter ended March 31, 2025, compared to approximately $4.3 million for the quarter ended March 31, 2024.

➢ G&A Expenses: General and administrative expenses were approximately $1.5 million for the quarter ended March 31, 2025, essentially unchanged from approximately $1.5 million for the quarter ended March 31, 2024.

➢ Net Loss: Net loss was approximately $4.5 million (or $0.42 per share) for the quarter ended March 31, 2025, compared to a net loss of approximately $5.4 million (or $0.51 per share) for the quarter ended March 31, 2024.

➢ Warrant Exercises: There were no warrants exercised during the three months ended March 31, 2025. The company has warrants to purchase 70,000 shares of common stock outstanding and exercisable as of March 31, 2025 at a weighted-average exercise price of $18.75 per share. These warrants will expire on June 10, 2025.