Outrun Therapeutics unveils lead programme targeting HPV positive head and neck cancer and appoints renowned E3 ligase experts to Scientific Advisory Board (SAB)

On March 17, 2026 Outrun Therapeutics ("Outrun" or "the Company"), a biotech developing protein stabilising therapeutics identified by its proprietary XL discovery platform, reported the selection of its lead programme for the treatment of HPV positive head and neck cancer. It also announced the formation of its Scientific Advisory Board comprising world-class experts in E3 ligase biology and head and neck cancer.

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Outrun has selected an E6AP inhibitor strategy as the lead programme from its first-in-class therapeutic pipeline developed through the application of its proprietary XL discovery platform. This platform has been used to profile over 45 diverse E3 ligases across a wide range of indications in oncology, neurology, cardiovascular and auto-immune diseases. The Company expects to announce a development candidate later this year.

E6AP is an E3 ubiquitin ligase that regulates the expression of a key tumour suppressor protein in HPV positive cancers, such as head and neck cancer. Inhibiting this enzyme represents a first-in-class strategy to directly stabilise tumour suppressor protein levels, paving the way to a meaningful impact on patients’ lives. HPV positive cancers account for around 4.5% of cancers worldwide, with the global market size expected to exceed $14 billion by 2031.

To help drive the advancement of the programme and the Company’s wider pipeline of first-in-class small molecule E3 ligase inhibitors, Outrun has appointed leading experts Glenn Hanna, Kevin Harrington, Gigi Lozano, Donald Ogilvie, and Martin Scheffner to its SAB. They join Outrun’s Founder, Non-executive Director, and Chair of the SAB, Professor Satpal Virdee.

These international experts bring extensive expertise in E3 ligase biology and head and neck cancer and will provide critical translational insights as Outrun advances its lead programme towards the clinic.

Dr Tony Johnson, Board Chair and Interim CEO of Outrun Therapeutics, said: "Outrun’s mission is to develop protein stabilising therapeutics to treat disease, and the selection of our lead programme, for the treatment of HPV positive head and neck cancer, is an important milestone in our journey. This is a massively underserved patient population, and we are confident that our novel approach to protein stabilisation offers a breakthrough route to bringing meaningful treatments to those in need."

Professor Satpal Virdee, Founder, Non-executive Director, and Chair of the SAB at Outrun Therapeutics, added: "Attracting such high-profile and experienced figures to our SAB is tremendous validation of the novel nature of our technology, and we are grateful for their commitment. Their expertise will be invaluable as we develop the translational strategy, clinical design, and biomarker validation to support our goal of establishing efficacy and differentiation in the HPV-induced head and neck cancer field, and transition to a clinical stage company."

(Press release, Outrun Therapeutics, MAR 17, 2026, View Source [SID1234663623])

ORIC® Pharmaceuticals Announces Preclinical Rinzimetostat (ORIC-944) Presentations at the 2026 American Association for Cancer Research (AACR) Annual Meeting

On March 17, 2026 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported that multiple abstracts highlighting the potential of rinzimetostat (ORIC-944), a potent and selective allosteric inhibitor of PRC2 to treat prostate cancer, have been accepted for poster presentations at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place April 17-22, 2026 in San Diego, CA. All regular abstracts are available for viewing via AACR (Free AACR Whitepaper)’s online itinerary planner located here.

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Poster presentations details:

Date & Time: Wednesday, April 22, 2026, 9:00 a.m. – 12:00 p.m. PT
Session Category: Experimental and Molecular Therapeutics
Session Title: Novel Strategies to Reverse Drug Resistance
Location: Poster Section 14

Title: Rinzimetostat, an allosteric EED inhibitor with best-in-class properties for the treatment of prostate cancer, is effective in PRC2 methyltransferase-resistant settings in preclinical studies
Abstract Number: 7120
Poster Number: Board Number 9

Abstract Highlights
Rinzimetostat is a potent and highly selective next-generation allosteric PRC2 inhibitor targeting the EED subunit that has demonstrated potential best-in-class efficacy and safety in a dose exploration trial in combination with androgen receptor (AR) inhibitors. To further evaluate the possible benefits of inhibiting PRC2 activity through EED targeting, preclinical studies investigated rinzimetostat versus EZH2- or EZH1/2-targeting agents in the context of proposed acquired resistance mechanisms. Biochemical assays demonstrated that rinzimetostat maintained potent inhibition of PRC2 complexes containing either EZH1 or EZH2 as the enzymatic subunit, while EZH2 or EZH1/2 dual inhibitors showed reduced activity in EZH1-containing complexes. Consistent with the biochemical data, rinzimetostat retained antitumor activity in prostate cancer cells overexpressing EZH1, while EZH2 inhibitors mevrometostat and tazemetostat lost potency in this context. Rinzimetostat also maintained inhibition of H3K27me3 in prostate cancer cells expressing the clinically reported EZH2-inhibitor acquired resistance mutation EZH2 Y666N, while EZH2 inhibitors did not reduce H3K27me3. In addition, in prostate cancer cells expressing the acquired resistance mutation EED-H213R, which is associated with clinical resistance to dual EZH1/2 inhibition, rinzimetostat equally inhibited H3K27me3 in both mutant and wild-type settings, while an EZH1/2 inhibitor did not. Together, these data suggest that rinzimetostat, as an EED inhibitor, has the potential for superiority in resistance context of EZH1 overexpression, as well as in acquired resistance mutant contexts of EZH2 and EZH1/2 inhibitors. A global phase 1b trial of rinzimetostat in combination with AR inhibitors is ongoing in metastatic prostate cancer (NCT05413421).

Title: Rinzimetostat blockade of PRC2 activity, a key mechanism of treatment resistance, improves response of androgen receptor pathway inhibition across a spectrum of prostate cancer models
Abstract Number: 7132
Poster Number: Board Number 21

Abstract Highlights
Rinzimetostat is a potent and highly selective next-generation allosteric PRC2 inhibitor targeting the EED subunit that has demonstrated potential best-in-class efficacy and safety in a dose exploration trial in combination with AR inhibitors. Transcriptome analyses of more than 1,000 prostate cancer patient samples spanning primary prostate cancer, metastatic castration-resistant prostate cancer (mCRPC), and neuroendocrine prostate cancer (NEPC) revealed gene expression patterns driving prostate cancer progression. Pseudotime analysis of tumor transcriptomes highlighted the eventual reduction in AR expression, AR signaling and luminal identity during mCRPC that may reflect lineage plasticity and cell state reprogramming. Integrated analysis across treatment lines identified epigenetic regulators, including PRC2, whose activity signatures increase during disease progression and may contribute to tumor heterogeneity and resistance to androgen receptor pathway inhibitors (ARPIs), further supporting the rationale for PRC2 inhibition. Rinzimetostat in combination with the AR inhibitor darolutamide demonstrated antitumor activity across a broad spectrum of in vivo prostate cancer models representing the treatment continuum, including castration-sensitive and castration-resistant disease, ARPI-sensitive and ARPI-resistant settings, and tumors harboring both AR-mutant and AR wild-type backgrounds. Together, these findings suggest that targeting PRC2 with rinzimetostat re-sensitizes ARPI-resistant tumors to AR pathway inhibition and blocks prostate tumor adaptation. A global phase 1b trial of rinzimetostat in combination with AR inhibitors is ongoing in metastatic prostate cancer (NCT05413421).

(Press release, ORIC Pharmaceuticals, MAR 17, 2026, View Source [SID1234663622])

One-carbon Therapeutics Announces Strategic Collaboration with Tempus to Advance Molecular Insights and Enable Precision Oncology Development of TH9619

On March 17, 2026 One-carbon Therapeutics, a clinical-stage oncology company pioneering first-in-class targeted therapies based on deep understanding into cancer biology, reported a strategic collaboration with Tempus AI Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine. The collaboration will leverage Tempus’ proprietary, de-identified multimodal database and bioinformatics expertise to advance molecular insights supporting the clinical development of TH9619.

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Through this collaboration, One-carbon Therapeutics will utilize Tempus’ analytical services to characterize the expression landscape across prioritized solid tumor indications. By integrating RNA sequencing data with clinical variables, the teams aim to uncover deep molecular insights that will inform the development of TH9619.

"Understanding the molecular dynamics of one-carbon metabolism across tumor types and treatment settings is fundamental to advancing TH9619 with precision," said Ana Slipicevic, Chief Executive Officer at One-carbon Therapeutics. "Tempus’ depth of molecular data and analytical rigor enables us to generate statistically robust evidence that can potentially guide clinical decision making and optimize development."

"At Tempus, our goal is to accelerate progress in oncology by translating complex molecular insights into meaningful therapeutic advances," said Ezra Cohen, MD, Chief Medical Officer, Oncology, at Tempus. "Through comprehensive analysis of our multimodal dataset, we are supporting One-carbon Therapeutics in characterizing the metabolic signatures across diverse tumor types. These insights are essential to informing research strategies and advancing the development of next-generation targeted cancer therapies."

By deepening the understanding of the biological mechanisms and genetic profiles associated with one-carbon metabolism across tumor types, the collaboration will strengthen the precision-driven clinical strategy for TH9619. Building on a deep understanding of how cancer cells depend on this pathway, these analyses may help identify patient populations most likely to benefit from treatment. This approach has the potential to enhance development efficiency, reduce uncertainty and ultimately help ensure that innovative targeted therapies reach the patients who need them most.

(Press release, One-carbon Therapeutics, MAR 17, 2026, View Source [SID1234663621])

Monte Rosa Therapeutics Announces Fourth Quarter and Full-Year 2025 Financial Results and Business Updates

On March 17, 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 fourth quarter and full year ended December 31, 2025.

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"Monte Rosa is now on the cusp of Phase 2 trial initiations for three clinical-stage programs, each targeting expansive opportunities. Strengthened by our recent capital raise, our cash runway now extends into 2029 and enables us to fund aggressive development plans for each of our programs through multiple anticipated readouts and value inflection points," said Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics. "We recently presented clinical data from the Phase 1 study of our NEK7-directed MGD MRT-8102, demonstrating suppression of high-sensitivity C-reactive protein (hsCRP) at rates comparable to or better than those previously reported with biologic therapies, supporting the potential of MRT-8102 to be an oral best-in-class therapeutic among agents targeting the NLRP3/IL-1/IL-6 pathway. The unblinded SAD/MAD safety data announced today, combined with the recently announced 3-month results from our long-term cynomolgus (cyno) monkey toxicology study, further support the favorable safety/tolerability profile observed to date and wide therapeutic window of this drug candidate. In addition, today we released promising data from a cyno obesity study demonstrating substantial impact of NEK7 degradation on body weight and body fat composition, alone or in combination with semaglutide."

"Our preclinical and clinical data corroborate the important role of NEK7 in driving lipid and metabolite-induced inflammation and support further development of MRT-8102 in cardiovascular and cardiometabolic indications," said Filip Janku, M.D., Ph.D., Chief Medical Officer of Monte Rosa Therapeutics. "Dosing is underway in our expanded GFORCE-1 study in subjects with elevated cardiovascular disease (CVD) risk, with additional results expected in H2 2026, and we look forward to initiating multiple Phase 2 studies of MRT-8102, starting with an ASCVD study this year. We’re excited that our VAV1-directed MGD MRT-6160, in collaboration with Novartis, is advancing towards multiple Phase 2 study initiations in immune-mediated diseases. Additionally, based on the promising data from our Phase 1/2 study of MRT-2359 in combination with an AR inhibitor in mCRPC patients, we plan to initiate a new Phase 2 study this year to evaluate MRT-2359 in combination with the second-generation AR-inhibitor apalutamide in patients with AR mutations, a population with limited therapeutic options. We are very pleased to have entered into a supply agreement with Johnson & Johnson for the provision of apalutamide for this study."

RECENT HIGHLIGHTS

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


In January, Monte Rosa announced positive interim data from an ongoing Phase 1 clinical study evaluating MRT-8102. In subjects with elevated cardiovascular disease (CVD) risk, MRT-8102 demonstrated rapid and durable reductions in systemic inflammation. 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. Single ascending dose (SAD) and multiple ascending dose (MAD) cohorts demonstrated deep and sustained NEK7 degradation at doses from 5 mg to 400 mg.

Monte Rosa reported unblinded safety data from the SAD/MAD cohorts of the Phase 1 study. In a total of 88 participants treated, there were no serious adverse events (SAEs), and no treatment-emergent adverse events (AEs) over grade 2. Rates of treatment-emergent AEs were 22% in subjects treated with MRT-8102, compared with 32% in subjects treated with placebo. The most frequent treatment-emergent AE was headache, reported in 9% of participants treated with MRT-8102 and 9% of participants treated with placebo. The data support a broad therapeutic index for MRT-8102.

Monte Rosa recently provided topline 3-month results from the ongoing long-term toxicology study in cynos. No test article-related findings were reported and the no observed adverse events level (NOAEL) was the highest dose tested, a dose approximately 200 – 300-fold over the projected human efficacious dose. These findings reinforce the favorable safety and tolerability profile observed to date in the ongoing Phase 1 clinical study of MRT-8102 and in the 28-day preclinical GLP toxicology studies.

In a cyno model of high-fat diet-induced obesity, daily dosing of a NEK7 MGD for 11 weeks produced an approximately 8% reduction in body weight relative to vehicle-treated animals. When combined with the GLP-1 receptor agonist semaglutide, body weight loss exceeded 23% relative to the vehicle group (versus 17% for semaglutide monotherapy). These findings are consistent with similar studies conducted with MRT-8102, both alone and in combination with semaglutide, in a mouse model of high-fat diet-induced obesity. Notably, DEXA body composition analysis of the cynos revealed preferential reductions in central abdominal fat, a depot strongly associated withincreased metabolic risk, with proportionally greater loss compared with the gynoid fat depot and minimal impact on lean mass.

As announced in January, the ongoing GFORCE-1 Study of MRT-8102 in subjects with elevated CVD risk has been expanded to multiple dose levels to accelerate development in atherosclerotic cardiovascular disease (ASCVD) with an anticipated readout in H2 2026. Dosing is now ongoing in the additional dose cohorts.

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 NLPR3/IL-1/IL-6 pathway:

A study (GFORCE-2) of MRT-8102 in elevated CVD risk patients defined by Stage 3/4 chronic kidney disease and elevated CRP, 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

A study (GFORCE-3) of MRT-8102 in patients with gout flares, expected to initiate in Q4 2026 or Q1 2027

A study (GFORCE-4) of MRT-8102 in patients with moderate to severe hidradenitis suppurativa, expected to initiate in H1 2027

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


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.

In October, Monte Rosa presented additional supportive MRT-6160 preclinical data at ACR Convergence 2025. In a preclinical autoimmune disease model characterized by chronic inflammation, autoantibody production, and multi-organ involvement, administration of MRT-6160 resulted in broad activity across an array of disease markers, including attenuated autoantibody levels and reduced skin and kidney pathology.

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


In February, Monte Rosa announced additional interim data from an ongoing Phase 1/2 clinical study evaluating MRT-2359 in combination with enzalutamide in heavily pretreated patients with mCRPC. 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. The data bolster the promising results shared in December, reinforcing MRT-2359’s potential in mCRPC.

The Company plans to initiate a Phase 2 study 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.

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 and CDK2-directed MGD programs for solid tumors


Monte Rosa continues to advance its cyclin E1 (CCNE1)- and CDK2-directed MGD programs for the treatment of CCNE1-amplified solid tumors and ER+ breast cancer toward clinical development. The Company expects to submit an IND application in 2026 for a cyclin E1-directed MGD.

Corporate


In January, Monte Rosa closed an upsized underwritten public offering of 13,000,000 shares of its common stock, including the full exercise by the underwriters of their option to purchase an additional 1,875,000 shares, at a public offering price of $24.00 per share and, in lieu of common stock to certain investors, pre-funded warrants to purchase 1,375,000 shares of common stock at a public offering price of $23.9999 per pre-funded warrant, which represents the per share public offering price of each share of common stock less the $0.0001 per share exercise price for each pre-funded warrant. The gross proceeds to Monte Rosa from the offering, before deducting underwriting discounts and commissions and offering expenses, were approximately $345 million. All of the shares and pre-funded warrants in the offering were sold by Monte Rosa.

In September 2025, Monte Rosa announced a second agreement to collaborate with Novartis to develop novel degraders for immune-mediated diseases. Monte Rosa’s publicly disclosed pipeline programs are outside the scope of this agreement. Under the terms of the agreement, Monte Rosa received an upfront payment of $120 million. Monte Rosa will also receive payments to maintain the options. In total deal value, Monte Rosa is eligible to receive up to $5.7 billion, including upfront, option maintenance, preclinical milestone, option exercise, and development, regulatory, and sales milestone payments across programs, as well as tiered royalties on global net sales in the high single to low double-digit range.

In December 2025, Monte Rosa achieved a preclinical milestone under its strategic collaboration and license agreement with Roche, triggering a $7 million milestone payment to Monte Rosa.

Monte Rosa reported two leadership team promotions: Magnus Walter, DPhil, to Chief Technology Officer, and Andrew Funderburk to Chief Investor Relations and Strategy Officer.

ANTICIPATED UPCOMING MILESTONES AND DEVELOPMENT PRIORITIES

Immunology and Inflammation disease programs


Readout of MRT-8102 GFORCE-1 study in subjects with elevated CVD risk anticipated in H2 2026.

Initiate multiple Phase 2 studies of MRT-8102, including in elevated CVD risk patients with Stage 3/4 chronic kidney disease in H2 2026, in gout flare patients in Q4 2026/Q1 2027, and in hidradenitis suppurativa patients in H1 2027.

Submit an IND application for a second-generation NEK7-directed MGD in 2026.


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


Initiate the MODeFIRe-1 Phase 2 study of MRT-2359 in combination with apalutamide in mCRPC in Q3 2026.

Submit an IND application for a cyclin E1-directed MGD in 2026.

FOURTH QUARTER AND FULL YEAR 2025 FINANCIAL RESULTS

Collaboration Revenue: Collaboration revenue for the fourth quarter of 2025 was $2.8 million, compared to $60.6 million for the fourth quarter of 2024, and $123.7 million for the year ended December 31, 2025, as compared to $75.6 million for the year ended December 31, 2024. 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 fourth quarter of 2025 were $42.0 million, compared to $38.9 million for the fourth quarter of 2024, and $141.5 million for the year ended December 31, 2025, compared to $121.6 million for the year ended December 31, 2024. These increases were driven by increased spending during the year on our MRT-8102 program and on other development and discovery programs.

General and Administrative (G&A) Expenses: G&A expenses for the fourth quarter of 2025 were $10.5 million compared to $8.8 million for the fourth quarter of 2024, and $36.4 million for the year ended December 31, 2025, compared to $35.2 million for the year ended December 31, 2024. 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 fourth quarter of 2025 was $46.1 million, compared to $13.4 million for the fourth quarter of 2024, and net loss for the year ended December 31, 2025, was $38.6 million, compared to $72.7 million for the year ended December 31, 2024.

Cash Position and Financial Guidance:

Cash, cash equivalents, restricted cash, and marketable securities as of December 31, 2025, were $382.1 million, compared to cash, cash equivalents, restricted cash, and marketable securities of $396.2 million as of September 30, 2025. The decrease of $14.1 million was primarily due to operational use of cash, partially offset by proceeds of $24.3 million from the sale of stock under our at-the-market program.

In January 2026, the Company closed an underwritten public equity offering of approximately $345.0 million aggregate gross proceeds. Aggregate net proceeds from the offering after deducting underwriting discounts and commissions and offering expenses are expected to be approximately $323.8 million.

Based on current cash, cash equivalents, restricted cash, and marketable securities, together with the proceeds from the 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, MAR 17, 2026, View Source [SID1234663620])

Moleculin to Present at 38th Annual ROTH Conference

On March 17, 2026 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), reported that it will participate in a fireside chat at the 38th Annual ROTH Conference being held March 22-24, 2026 in Dana Point, CA.

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Details of the fireside chat presentation are as follows:

Date and Time: Tuesday, March 24, 2026 at 12:00-12:25 PM PT
Location: BROWN – HEALTHCARE – VIRTUAL (SUITE 1051)
Presenters: Walter Klemp, Founder, President, Chairman & CEO; Jon Foster, EVP & CFO
Registration Link: Here

Investors interested in arranging one-on-one meetings should contact their ROTH representative. For more information, please visit the conference website.

(Press release, Moleculin, MAR 17, 2026, View Source [SID1234663619])