On May 7, 2026 Nykode Therapeutics ASA (OSE: NYKD), a clinical stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported the dosing of the first patient in Abili-T, a randomised Phase II clinical trial evaluating abi-suva (formerly VB10.16) in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD1 therapy, KEYTRUDA (pembrolizumab) versus pembrolizumab alone as first-line treatment for patients with HPV16-positive, PD-L1-positive recurrent or metastatic head and neck squamous cell carcinoma (1L r/m HNSCC).

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The initiation of Abili-T marks a pivotal milestone in Nykode’s clinical development programme and reinforces the Company’s strategy to advance abi-suva as a targeted immunotherapy for the significant unmet medical need that exists in HPV16-driven cancers.

"Initiating the first patient in the Abili-T trial is an important step forward for Nykode and most importantly for patients with first-line recurrent/metastatic head and neck squamous cell carcinoma who continue to have significant unmet medical needs," said Michael Engsig, Chief Executive Officer at Nykode Therapeutics. "Abi-suva is designed to generate strong and durable HPV16-specific immune responses and we look forward to generating data in a randomized setting. We are grateful to the clinical investigators and patients participating in this study."

"There is a significant unmet need for patients with HPV16-driven head and neck cancer, particularly in the first-line setting," said Åse Bratland, Coordinating Investigator of the Abili-T trial, The Norwegian Radium Hospital, Oslo University Hospital. "Abi-suva is designed to generate a targeted and durable immune response and combining it with pembrolizumab may offer a meaningful new approach for these patients. We are hopeful that this study will provide important insights and, ultimately, lead to improved outcomes."

Abili-T is a randomised, open-label, multicentre Phase II trial evaluating abi-suva in combination with pembrolizumab versus pembrolizumab alone as first-line treatment in patients with HPV16-positive, PD-L1-positive recurrent or metastatic head and neck squamous cell carcinoma (1L r/m HNSCC).

The trial will enroll approximately 100 patients across 40 sites in Europe and Canada. Patients will be randomised to receive either abi-suva in combination with pembrolizumab or pembrolizumab alone. The primary endpoints are progression-free survival (PFS) and objective response rate (ORR). Secondary endpoints include duration of response (DOR), disease control rate (DCR), and overall survival (OS).

The Abili-T trial follows the successful completion of three prior clinical studies with abi-suva, VB-C-01, VB-C-02 and VB-C-03, which established the safety and tolerability of abi-suva as monotherapy and in combination with checkpoint inhibitors and demonstrated a strong and durable clinical effect in patients with advanced HPV16-driven cancers.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. KEYTRUDA has been supplied by MSD for the Abili-T trial according to the clinical trial collaboration and supply agreement between Nykode and MSD.

Disease Background and Market Opportunity

The combined incidence of HPV16-positive HNSCC in the EU and US is approximately 63,000 new cases annually and the incidence of HPV16-driven HNSCC is rising.

Despite recent advances in immuno-oncology, patients with recurrent or metastatic HNSCC continue to face a significant unmet medical need. Current standard of care achieves an objective response rate of 19% and a median overall survival of 12.3 months. The majority of treatments currently in development for HNSCC are focused on HPV-negative disease, leaving the HPV16-positive patient population particularly underserved.

Beyond HNSCC, abi-suva has the potential to address a broader HPV16-driven cancer population including cervical, anal, vulvar and penile cancers with an annual incidence of approximately 134,000 patients annually in Europe and the US. This broader opportunity is supported by the clinical data generated in the VB-C-02 trial, which demonstrated strong and durable clinical effects in advanced cervical cancer patients, and in the VB-C-01 demonstrating a promising efficacy and favorable safety profile and confirmed the induction of robust HPV16-specific T-cell responses in pre-cancerous lesions (CIN).

(Press release, Nykode Therapeutics, MAY 7, 2026, View Source [SID1234665339])

On May 7, 2026 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported pipeline progress, reiterated key anticipated milestones, and reported first quarter 2026 financial results.

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"The forward momentum continues at Nuvalent, with both of our parallel-lead programs advancing toward key US regulatory milestones and the opportunity to bring our first new medicine to patients this year," said James Porter, Ph.D., Chief Executive Officer of Nuvalent. "We recently submitted our NDA for neladalkib in TKI pre-treated ALK-positive NSCLC and are continuing to build our commercial infrastructure in preparation for a potential US launch of zidesamtinib in TKI pre-treated ROS1-positive NSCLC, if approved."

Dr. Porter continued, "Beyond these initial opportunities, we remain focused on progressing our label expansion strategies for ROS1- and ALK-positive NSCLC, as well as our earlier-stage pipeline, with the goal of driving meaningful, long-term impact in NSCLC and beyond. Through these efforts, we believe we are well positioned to realize our vision of becoming a sustainable biotechnology company capable of designing, developing and delivering precisely targeted therapies for patients with cancer."

Recent Pipeline Achievements and Anticipated Milestones

ROS1 Program

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The New Drug Application (NDA) for zidesamtinib, an investigational ROS1-selective inhibitor, is under review by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who received at least 1 prior ROS1 tyrosine kinase inhibitor (TKI) with a Prescription Drug User Fee Act (PDUFA) target action date of September 18, 2026. Nuvalent continues to advance commercial preparations ahead of an anticipated U.S. commercial launch of zidesamtinib in 2026, pending FDA review.
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Nuvalent plans to submit data to the FDA to support a potential label expansion of zidesamtinib in TKI-naïve patients with advanced ROS1-positive NSCLC in the second half of 2026.
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Nuvalent presented new clinical and preclinical data for zidesamtinib during poster sessions at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, including:
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Clinical data from a subgroup of patients with advanced ROS1-positive NSCLC in the ARROS-1 clinical trial who had been previously treated with the dual TRK/ROS1 TKIs repotrectinib and/or taletrectinib. Treatment with zidesamtinib resulted in clinically meaningful activity in this heavily pre-treated subgroup, including activity in tumors with the ROS1 G2032R resistance mutation and intracranial complete responses for patients with CNS disease. These results indicate that ROS1-positive NSCLC tumors may remain ROS1-dependent beyond treatment with repotrectinib or taletrectinib.
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Preclinical analyses supporting the potential for differentiation of the brain penetrance and intracranial ROS1 G2032R antitumor activity of zidesamtinib compared to the dual TRK/ROS1 inhibitors repotrectinib and taletrectinib. Among these three ROS1 TKIs, zidesamtinib demonstrated the highest in vitro measures of brain penetrance, most sustained intracranial efficacy in a mouse ROS1 G2032R brain tumor model, and efficacy after progressive disease on earlier-line taletrectinib treatment in a mouse ROS1 G2032R brain tumor model. Data demonstrating that switching from repotrectinib to zidesamtinib resulted in more sustained tumor suppression in the same preclinical model have been previously reported.1
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The company also plans to present preliminary data from the ongoing ARROS-1 Phase 1/2 clinical trial of zidesamtinib in patients with advanced ROS1-positive solid tumors outside of non-small cell lung cancer (NSCLC) during a poster session at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from May 29 – June 2, 2026, in Chicago.
1Tangpeerachaikul et al. Annals of Oncology 2024; 35(2):S217.

ALK Program

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Nuvalent submitted an NDA for neladalkib, an investigational ALK-selective inhibitor, in TKI pre-treated advanced ALK-positive NSCLC to the FDA. The application is based on data in TKI pre-treated patients with advanced ALK-positive NSCLC treated with neladalkib in the global, registration-directed ALKOVE-1 Phase 1/2 clinical trial. In this population, neladalkib demonstrated encouraging overall activity, including intracranial responses, the ability to address key drivers of disease progression, and a generally well-tolerated safety profile consistent with its ALK-selective, TRK-sparing design. The company plans to present pivotal data for neladalkib in TKI pre-treated patients with advanced ALK-positive NSCLC from the ALKOVE-1 study, in addition to preliminary data for TKI-naïve patients, during an oral presentation at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting.
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Enrollment is ongoing in ALKAZAR, the company’s global Phase 3 randomized, controlled trial designed to evaluate neladalkib for the treatment of patients with TKI-naïve ALK-positive NSCLC. Patients are randomized 1:1 to receive neladalkib or alectinib, a front-line standard of care, reflecting input from collaborating physician-scientists and alignment with global regulatory agencies. The company expects to continue to progress the ALKAZAR trial throughout 2026.

HER2 Program

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Enrollment is ongoing in the HEROEX-1 Phase 1a/1b clinical trial evaluating the overall safety and tolerability of NVL-330 for pre-treated patients with HER2-altered NSCLC. Additional objectives include determination of the recommended Phase 2 dose, characterization of NVL-330’s pharmacokinetic profile, and preliminary evaluation of anti-tumor activity. The company expects to continue to progress the HEROEX-1 trial throughout 2026.

Discovery Research Programs

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Nuvalent continues to make progress across its discovery research programs and expects to disclose a new development candidate by year-end 2026.

Recent Leadership Promotions

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Benjamin Lane, Ph.D., Promoted to Chief Technology Operations Officer: Ben joined Nuvalent in 2020, bringing more than 20 years of experience focused on the development of pre-clinical through commercial programs at both large and small biotech companies. Most recently, Ben served as Senior Director, Process Chemistry at Agios Pharmaceuticals where he led the process chemistry group and was responsible for pre-clinical to commercial drug substance development and manufacturing, including for the mitapivat program (now marketed as AQVESME and PYRUKYND). Prior to Agios, Ben served in various drug development leadership roles at Infinity Pharmaceuticals and Biogen.
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Kirsten Duncan, Pharm.D., Promoted to Vice President, Medical Affairs: Kirsten joined Nuvalent in 2024, bringing more than 25 years of experience across biopharma, with a focus on oncology strategy and stakeholder engagement. Prior to joining Nuvalent, Kirsten spent more than five years at Pfizer, most recently as Director, Thoracic Oncology, where she led global medical affairs strategy across the lung cancer franchise. Prior to Pfizer, Kirsten served in various medical affairs leadership roles at Arivale, Percolation Communications, Duncan Communications, and OnCare.

Upcoming Events

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TD Cowen 7th Annual Oncology Innovation Summit: Management will be participating in a virtual fireside chat on Wednesday, May 27, 2026, at 9:30 a.m. ET.
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2026 Jefferies Healthcare Conference in New York: Management will be participating in a fireside chat on Thursday, June 4, 2026, at 11:40 a.m. ET.
A live webcast of each fireside chat will be available in the Investors section of Nuvalent’s website at www.nuvalent.com, and will be archived for 30 days following the conference.

First Quarter 2026 Financial Results

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Cash Position: Cash, cash equivalents and marketable securities were $1.3 billion as of March 31, 2026. Nuvalent continues to believe that its existing cash, cash equivalents and marketable securities will be sufficient to fund its operations into 2029.
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R&D Expenses: Research and development (R&D) expenses were $83.6 million for the first quarter of 2026.
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G&A Expenses: General and administrative (G&A) expenses were $35.8 million for the first quarter of 2026.
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Net Loss: Net loss was $109.3 million for the first quarter of 2026.

(Press release, Nuvalent, MAY 7, 2026, View Source [SID1234665338])

On May 7, 2026 NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel therapies to treat cancer, reported a business update and announced first quarter 2026 financial results.

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"Our SIM0505 program reached critical milestones this quarter, headlined by the U.S. Food and Drug Administration (FDA) granting Fast Track designation for platinum-resistant ovarian cancer (PROC) and the upcoming presentation of initial Phase 1 data at the American Society for Clinical Oncology (ASCO 2026)," said Michael Richman, President and CEO of NextCure. "We believe Fast Track designation validates the potential of this CDH6 antibody drug conjugate (ADC) and the urgent need for new therapies. As we prepare to present our data at ASCO (Free ASCO Whitepaper) 2026, we are also focusing on accelerating development, with plans to increase our U.S. trial sites and expand our footprint into Canada and Europe. With the recent initiation of the dose optimization this month, we are fully committed to bringing this transformative treatment to patients."

Business Highlights and Near-Term Milestones

SIM0505 (CDH6 ADC): Phase 1 dose escalation data expected in Q2 2026

SIM0505 is a novel ADC directed to cadherin-6 (CDH6 ADC), overexpressed in several cancers including ovarian cancer, with limited expression in healthy tissues. SIM0505 features a proprietary topoisomerase 1 inhibitor (TOPOi) payload, designed for broad anti-tumor activity, fast systemic clearance and an improved potential therapeutic window.

● Received Fast Track designation for the treatment of women with PROC from the FDA.
● Data from the Phase 1 open-label dose escalation study in patients with advanced solid tumors with a focus on gynecological cancers and an emphasis on PROC (NCT06792552) are expected to be presented at ASCO (Free ASCO Whitepaper) 2026 on June 1, 2026, including results from patients in the U.S. and China.
● Announced in May 2026 the initiation of the Phase 1 dose optimization study in gynecologic cancers by dosing patients with PROC. NextCure anticipates increasing the number of trial sites in the second half of 2026, including the activation of sites in Canada and Europe, with continued study site additions in 2027.

LNCB74 (B7-H4 ADC): Ongoing enrollment in Phase 1 dose escalation

LNCB74 is a novel ADC directed to B7-H4, overexpressed in several cancers, with limited expression in healthy tissues. LNCB74 features a proprietary tumor-selective cleavable linker and a tubulin inhibitor monomethyl auristatin E (MMAE) payload.

● Ongoing open-label Phase 1 dose escalation study (NCT06774963) continues to prioritize patients with high B7-H4 expression in breast and gynecological cancers, as well as the inclusion of patients with adenoid cystic carcinoma type 1. NextCure intends to backfill patients to investigate particular dose levels and schedules in the expected therapeutic window.
● Trial progress update planned in the second half of 2026.

Financial Results for the Quarter Ended March 31, 2026

● Cash, cash equivalents, and marketable securities as of March 31, 2026 were $29.7 million as compared to $41.8 million as of December 31, 2025. The decrease of $12.1 million was primarily due to cash used to fund operations of $13.4 million, partially offset by proceeds of $1.2 million from equity sales under our existing ATM program. NextCure expects current financial resources to be sufficient to fund operating expenses and capital expenditures into the first half of 2027 through proof-of-concept for SIM0505.
● Research and development expenses were $6.8 million for the three months ended March 31, 2026, as compared to $7.9 million for the three months ended March 31, 2025. The decrease of $1.1 million was due to lower costs related to deprioritized programs which were largely offset by costs for the SIM0505 program, and lower personnel costs, primarily non-cash stock compensation costs and lower depreciation.
● General and administrative expenses were $3.3 million for the three months ended March 31, 2026, as compared to $3.7 million for the three months ended March, 2025. The decrease of $0.4 million was primarily related to lower non-cash stock compensation costs.
● Net loss was $9.8 million for the three months ended March 31, 2026, as compared to a net loss of $11.0 million for the three months ended March 31, 2025. The lower net loss for the three months ended March 31, 2026 as compared to the three months ended March 31, 2025 was driven by the lower research and development and general and administrative expenses mentioned above, partially offset by lower other income of $0.3 million.

About SIM0505

SIM0505 is a novel ADC directed to CDH6 ADC, featuring a proprietary TOPOi payload. The ADC is designed for broad anti-tumor activity, fast systemic clearance and an improved potential therapeutic window. SIM0505 is being evaluated in an open-label, Phase 1 study for the potential treatment of advanced solid tumors, including ovarian cancer, with an emphasis on platinum resistant ovarian cancer. NextCure holds exclusive global rights for SIM0505, excluding China, Hong Kong, Macau, and Taiwan which are retained by Simcere Zaiming Pharmaceutical Co., Ltd.

About LNCB74

LNCB74 is a novel ADC directed to B7-H4, featuring a proprietary tumor-selective cleavable linker and a tubulin inhibitor MMAE payload. LNCB74 is being evaluated in an open-label, Phase 1 dose escalation study for the potential treatment of advanced solid tumors. NextCure shares global co-development rights with LigaChem Biosciences, Inc. through a 50-50 cost share arrangement.

(Press release, NextCure, MAY 7, 2026, View Source [SID1234665337])

On May 7, 2026 Nektar Therapeutics (Nasdaq: NKTR) reported financial results for the first quarter ended March 31, 2026.

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Cash and investments in marketable securities on March 31, 2026, were $731.6 million as compared to $245.8 million on December 31, 2025. Nektar’s cash and marketable securities at March 31, 2026, exclude net proceeds of approximately $351 million from the secondary offering completed by the Company on April 23, 2026.

"2026 is shaping up to be a defining year for Nektar and for our lead biologic candidate rezpegaldesleukin," said Howard W. Robin, President and Chief Executive Officer of Nektar. "We have now shown that longer-term treatment with rezpegaldesleukin continues to deepen clinical responses in two distinct immune-mediated diseases, reinforcing our belief that this novel Treg mechanism can transform the treatment paradigm for autoimmune disease. The Phase 3 ZENITH-AD program in atopic dermatitis will initiate by July, and we will have our End-of-Phase 2 meeting for alopecia areata this quarter. With a substantially strengthened balance sheet and over one billion dollars in cash and investments, we are well positioned to advance rezpegaldesleukin into late-stage development with strong scientific and clinical conviction."

Revenue in the first quarter of 2026 was $10.9 million as compared to $10.5 million in the first quarter of 2025.

Total operating costs and expenses in the first quarter of 2026 were $49.9 million as compared to $55.0 million in the first quarter of 2025. Operating expenses decreased due to a decrease in G&A expenses, partially offset by an increase in R&D expenses.

R&D expense in the first quarter of 2026 was $35.7 million as compared to $30.5 million for the first quarter of 2025. R&D expense increased primarily due to increased expenses for the development of rezpegaldesleukin as we commenced activities to support a Phase 3 program in atopic dermatitis.

G&A expense was $13.4 million in the first quarter of 2026 as compared to $24.3 million in the first quarter of 2025. G&A expense decreased primarily due to a decrease in legal expenses.

Our non-cash loss from our equity method investment in Gannet BioChem was $1.8 million in the first quarter of 2026, as compared to $4.5 million in the first quarter of 2025.

Net loss for the first quarter of 2026 was $44.9 million or $1.82 basic and diluted net loss per share as compared to net loss of $50.9 million or $3.621 basic and diluted loss per share in the first quarter of 2025.

Recent Business Highlights

● In April, Nektar closed a successful underwritten public offering of $373.8 million of shares of its common stock, including the exercise in full by the underwriters of their option to purchase additional shares of common stock.

● In April, Nektar announced topline results from the 16-week blinded treatment extension of REZOLVE-AA, demonstrating deepening of responses in severe-to-very-severe alopecia areata at 52 weeks.

● In March, Nektar presented data from the Phase 2b REZOLVE-AD and REZOLVE-AA studies of rezpegaldesleukin at the 2026 American Academy of Dermatology Annual Meeting.

● In February, Nektar established a Research Collaboration with UCSF and Dr. Stephen Hauser for NKTR-0165, a tumor necrosis factor receptor 2 (TNFR2) antibody, in multiple sclerosis.

● In February, Nektar closed a successful public offering of its common stock, including the full exercise of underwriters’ option to purchase additional shares, raising $460 million in gross proceeds.

● In February, Nektar presented new maintenance data from the REZOLVE-AD Phase 2b Study in atopic dermatitis, demonstrating durable and new responses with rezpegaldesleukin across key disease measurements with both monthly and quarterly dosing.

Upcoming Milestones

● Initiation of ZENITH-AD Phase 3 program of rezpegaldesleukin in moderate-to-severe atopic dermatitis by July 2026

● End-of-Phase 2 Meeting with FDA to align on Phase 3 program in alopecia areata in Q2 2026

● 24-week data from REZOLVE-AA off-treatment observation period in Q4 2026

● 52-week data from REZOLVE-AD off-treatment observation period in Q1 2027

● Initial data from TrialNet sponsored Phase 2 study in Type 1 Diabetes in 2027

● Preclinical data presentation from the NKTR-0165 (TNFR2 agonist antibody) program at a scientific conference in H2 2026

Conference Call to Discuss First Quarter 2026 Financial Results

Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time on May 7, 2026.

This press release and live audio-only webcast of the conference call can be accessed through a link that is posted on the Home Page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through June 7, 2026.

To access the conference call, please pre-register at Nektar Earnings Call Registration. All registrants will receive dial-in information and a PIN allowing them to access the live call.

(Press release, Nektar Therapeutics, MAY 7, 2026, View Source [SID1234665336])

On May 7, 2026 Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, reported business highlights and financial results for the first quarter ended March 31, 2026.

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"We continue to make excellent progress advancing multiple programs through the clinic, with all three of our clinical-stage programs approaching Phase 2 trial initiations," said Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics. "Building on interim clinical data for our NEK7-directed MGD MRT-8102 demonstrating rapid, deep, and durable reductions in systemic inflammation, we expect to read out the GFORCE-1 study in subjects with elevated cardiovascular disease (CVD) risk this year, and to initiate three Phase 2 studies, starting in H2 2026, in diseases driven by the NLRP3/IL-1/IL-6 pathway. We also expect our collaborator Novartis to initiate multiple Phase 2 studies of our VAV1-directed MGD MRT-6160 in immune-mediated diseases this year. In addition, our oncology programs are also progressing rapidly, in particular with a Phase 2 study initiation of MRT-2359 in metastatic castration-resistant prostate cancer (mCRPC) patients with androgen receptor (AR) mutations planned for Q3 2026, following the encouraging Phase 1/2 data we presented at ASCO (Free ASCO Whitepaper) GU."

RECENT HIGHLIGHTS

MRT-8102, NEK7-directed MGD for inflammatory diseases driven by the NLRP3 inflammasome, IL-1, and IL-6

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In January, Monte Rosa announced positive interim data from an ongoing Phase 1 clinical study evaluating MRT-8102. In subjects with elevated CVD risk, after four weeks of MRT-8102 administration, CRP levels decreased by 85%, and 94% of study participants achieved CRP levels below 2 mg/L, a threshold associated with reduced CVD risk. The Company subsequently announced unblinded safety data from the single ascending dose / multiple ascending dose (SAD/MAD) cohorts and 3-month results from the ongoing long-term toxicology study in cynomolgus monkeys support a broad therapeutic index for MRT-8102.
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The ongoing GFORCE-1 study of MRT-8102 in subjects with elevated CVD risk is evaluating multiple dose levels to accelerate development in atherosclerotic cardiovascular disease (ASCVD) with an anticipated readout in H2 2026.
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Monte Rosa expects to initiate multiple Phase 2 studies of MRT-8102 in indications with high unmet need and strong biologic rationale for targeting the NLRP3/IL-1/IL-6 pathway:
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A study (GFORCE-2) of MRT-8102 in patients with elevated atherosclerotic risk is expected to initiate in H2 2026 to evaluate the effect of MRT-8102 treatment for 12 weeks (plus open-label extension) on CRP levels, as well as effects on liver fat, liver inflammation, and obesity.
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A study of MRT-8102 in patients with gout flares is expected to initiate in Q4 2026 or Q1 2027.
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A study of MRT-8102 in patients with moderate to severe hidradenitis suppurativa is expected to initiate in H1 2027.

MRT-6160, VAV1-directed MGD for immune-mediated conditions

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Advancement of MRT-6160 toward multiple Phase 2 studies in immune-mediated diseases is ongoing, in collaboration with Novartis. Results from the Phase 1, single ascending dose / multiple ascending dose (SAD/MAD) study in healthy volunteers (clinicaltrials.gov identifier NCT06597799) support a clear path into anticipated Phase 2 studies and broad potential applications in multiple immune-mediated diseases.
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Monte Rosa has a global exclusive development and commercialization license agreement with Novartis to advance VAV1-directed MGDs, including MRT-6160. Monte Rosa is eligible to receive up to $2.1 billion in development, regulatory, and sales milestones, beginning upon initiation of Phase 2 studies. Novartis is responsible for conducting and funding Phase 2 studies. Monte Rosa will co-fund any Phase 3 clinical development and will share 30% of any profits and losses associated with the manufacturing and commercialization of MRT-6160 in the U.S., and is also eligible for tiered royalties on ex-U.S. net sales.

MRT-2359, GSPT1-directed MGD for metastatic CRPC

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In February, Monte Rosa presented additional interim data from an ongoing Phase 1/2 clinical study evaluating MRT-2359 in combination with enzalutamide in heavily pretreated patients with mCRPC at the ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU). MRT-2359 is an investigational, orally bioavailable, GSPT1-directed MGD. PSA responses in patients with AR mutations expanded to 5 of 5 patients, with a 100% disease control rate, including 2 patients with RECIST partial responses and 3 with stable disease, all showing reductions in size of target lesions. Across all 15 evaluable patients, the overall RECIST disease control rate was 67%, and 10 of 15 patients showed tumor size reductions of target lesions. The combination of MRT-2359 and enzalutamide was generally well-tolerated with primarily Grade 1-2 AEs. There were no treatment discontinuations due to AEs.

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The Company plans to initiate a Phase 2 study (MODeFIRe-1) in 2026 of up to 25 patients to efficiently assess the efficacy of MRT-2359 in combination with the second-generation AR inhibitor apalutamide in mCRPC patients with AR mutations, with potential to expand the study into additional patient subsets.
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In March, Monte Rosa announced it entered into a supply agreement with Johnson & Johnson to evaluate MRT-2359 in combination with ERLEADA (apalutamide) for the treatment of patients with mCRPC with androgen receptor (AR) mutations in its planned Phase 2 study.

Cyclin E1 (CCNE1)-directed MGD program for CCNE1-amplified solid tumors

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Monte Rosa presented preclinical data on the potential of its potent and highly selective cyclin E1 (CCNE1)-directed molecular glue degrader, MRT-55811, to treat CCNE1-amplified solid tumors at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026. MRT-55811 induced deep tumor regressions in CCNE1-amplified in vivo models of ovarian, breast, and gastric cancers, and demonstrated superior selectivity and reduced off-target activity compared to CDK2 inhibitors.
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Monte Rosa expects to submit an IND application for its CCNE1 MGD program in H2 2026. The Company expects to develop this molecule in ovarian cancer and other cancer types driven by CCNE1 amplification.

CDK2-directed MGD program for ER+ breast cancer

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Monte Rosa continues to advance its CDK2-directed MGD program for the treatment of ER+ breast cancer toward clinical development.

Corporate

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In January, Monte Rosa closed an upsized underwritten public offering. Gross proceeds, before deducting underwriting discounts and commissions and offering expenses, were $345 million.
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Monte Rosa continues to progress its collaboration with Novartis to develop novel degraders for immune-mediated diseases and its collaboration with Roche to discover and develop MGDs against targets in cancer and neurological diseases previously considered impossible to drug.

ANTICIPATED UPCOMING MILESTONES AND DEVELOPMENT PRIORITIES

Immunology and Inflammation programs

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Readout of MRT-8102 GFORCE-1 study in subjects with elevated CVD risk anticipated in H2 2026.
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Initiate multiple Phase 2 studies of MRT-8102, including in elevated atherosclerotic risk patients in H2 2026, in gout flare patients in Q4 2026/Q1 2027, and in hidradenitis suppurativa patients in H1 2027.
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Submit an IND application for a second-generation NEK7-directed MGD in H2 2026.
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Monte Rosa expects its collaborator, Novartis, to initiate multiple Phase 2 studies of VAV1-directed MGD MRT-6160 in immune-mediated diseases in 2026.
Oncology programs

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Initiate the MODeFIRe-1 Phase 2 study of MRT-2359 in combination with apalutamide in mCRPC in Q3 2026.
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Submit an IND application for a cyclin E1-directed MGD in H2 2026.

FIRST QUARTER 2026 FINANCIAL RESULTS

Collaboration Revenue: Collaboration revenue for the first quarter of 2026 was $4.2 million, compared to $84.9 million for the first quarter of 2025. Collaboration revenue represents amounts earned from the Company’s collaboration and license agreements with Roche and Novartis.

Research and Development (R&D) Expenses: R&D expenses for the first quarter of 2026 were $44.1 million, compared to $32.2 million for the first quarter of 2025. These increases were driven by increased spending during the quarter on our MRT-8102 program and on other development and discovery programs.

General and Administrative (G&A) Expenses: G&A expenses for the first quarter of 2026 were $10.2 million, compared to $8.7 million for the first quarter of 2025. These increases, which include non-cash stock-based compensation, were driven by increased headcount and expenses in support of our growth and operations as a public company.

Net Loss: Net loss for the first quarter of 2026 was $44.5 million, compared to $46.9 million net income for the first quarter of 2025.

Cash Position and Financial Guidance:

Cash, cash equivalents, restricted cash, and marketable securities as of March 31, 2026, were $671.2 million, compared to cash, cash equivalents, restricted cash, and marketable securities of $382.1 million as of December 31, 2025. The increase of $289.1 million was primarily due to net proceeds from the underwritten public offering in January, partially offset by operational use of cash.

In January 2026, the Company closed an underwritten public equity offering of

$345.0 million aggregate gross proceeds. Aggregate net proceeds from the offering after deducting underwriting discounts and commissions and offering expenses were $323.8 million.

Based on current cash, cash equivalents, restricted cash, and marketable securities, together with the proceeds from the January 2026 offering, the Company expects its cash and cash equivalents to be sufficient to fund planned operations and capital expenditures into 2029.

(Press release, Monte Rosa Therapeutics, MAY 7, 2026, View Source [SID1234665335])