On November 6, 2026 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small-molecule drugs targeting oncological and inflammatory diseases, reported its participation in BIO-Europe 2026, taking place November 9–11 in Cologne, Germany, with additional digital partnering sessions scheduled for November 17–18. BIO-Europe 2026.

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Dr. Sari Fishman, Vice President of Business Development, will represent Can-Fite at the conference, focusing on potential licensing agreements, co-development arrangements, commercialization partnerships, and other strategic transactions aimed at unlocking the commercial value of the Company’s advanced clinical pipeline.

Can-Fite enters BIO-Europe following a series of clinical and intellectual property developments that have strengthened its portfolio and expanded potential partnering opportunities across multiple therapeutic areas.

Key assets and partnering opportunities include:

• Namodenoson – Pancreatic Cancer: Final positive Phase IIa results, presented at ESMO (Free ESMO Whitepaper) 2026, demonstrated a favorable safety profile and encouraging exploratory survival findings in heavily pretreated patients, supporting further clinical development.

• Namodenoson – Liver Cancer: An ongoing pivotal Phase III study in advanced hepatocellular carcinoma (HCC), with longer-than-anticipated blinded overall survival observed across the study population. An interim analysis is planned.

• Piclidenoson – Psoriasis: A pivotal Phase III program that has reached its prespecified interim analysis stage, with results expected in the first quarter of 2027.

• Namodenoson – MASH: An ongoing Phase IIb clinical development program targeting a significant global market opportunity.

• Piclidenoson – Lowe Syndrome: A rare disease development program supported by a collaboration with Fondazione Telethon and recently strengthened by a Eurasian patent allowance covering Lowe syndrome and Dent disease 2.

Can-Fite has already established multiple regional licensing agreements, generating approximately $20 million in upfront and milestone payments to date, with the potential for additional milestones and royalties. The Company intends to build on this commercial track record by pursuing additional regional and broader strategic partnerships.

"BIO-Europe provides an important opportunity to translate our recent clinical and intellectual property progress into strategic business discussions," said Dr. Sari Fishman, Vice President of Business Development at Can-Fite BioPharma. "With two pivotal Phase III programs, encouraging new clinical data in pancreatic cancer, and an expanding portfolio of development and commercialization opportunities, we believe Can-Fite offers potential partners access to differentiated clinical-stage assets across several major therapeutic markets. Our objective is to pursue licensing and strategic collaborations that can accelerate development, expand global commercialization opportunities, and create long-term value for our shareholders."

BIO-Europe is one of the biopharmaceutical industry’s leading international partnering events, bringing together pharmaceutical companies, biotechnology developers, investors, and business development executives from around the world.

Dr. Fishman will be available for partnering discussions throughout the conference.

(Press release, Can-Fite BioPharma, NOV 6, 2026, View Source [SID1234674388])

On November 6, 2026 Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through development of its lead immune-activating antibody therapeutic, imneskibart (AU-007), reported positive Phase 2 data demonstrating clinical activity with imneskibart-based regimens in heavily pretreated patients with doublet checkpoint inhibitor (CPI)-refractory melanoma and CPI-refractory adenocarcinoma non-small cell lung cancer (NSCLC). The findings, presented in two posters at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in Phoenix, Arizona, demonstrate encouraging and durable anti-tumor activity in heavily pretreated patients with limited treatment options, with progression-free survival outcomes that compare favorably with historical benchmarks for available therapies.

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The melanoma results demonstrate strong and durable anti-tumor activity with imneskibart plus low-dose, subcutaneous aldesleukin, with and without nivolumab, in patients whose disease had progressed following prior doublet CPI therapy. The triplet regimen of imneskibart plus low-dose, subcutaneous aldesleukin and nivolumab achieved a median progression-free survival (PFS) of 9.1 months and an objective response rate (ORR) of 28% among 18 response-evaluable patients, including one confirmed complete response. The doublet regimen of imneskibart plus low-dose, subcutaneous aldesleukin without nivolumab achieved a median PFS of 6.9 months and ORR of 29%, including a confirmed complete response lasting more than 32 months. These outcomes are particularly encouraging given that patients had progressed despite prior combination checkpoint inhibitor therapy and received a mean of 2.7 prior lines of treatment in the triplet cohort and 2.4 prior lines in the doublet cohort. Published salvage-treatment studies in anti-PD-1-refractory melanoma reported median PFS of 4.2 months with lenvatinib plus pembrolizumab (LEAP-004) and 2.1 to 3.2 months with nivolumab plus relatlimab (RELATIVITY-020), although these studies included different patient populations. A 2026 multicenter retrospective study by the Dermatologic Cooperative Oncology Group (DeCOG) of 120 heavily pretreated patients with advanced melanoma receiving anti-PD-1 plus lenvatinib reported median PFS of 3.5 months; 98% had previously received ipilimumab plus nivolumab. This provides a particularly relevant, though nonrandomized, historical context for the 9.1- and 6.9-month median PFS outcomes reported here.

The NSCLC results provide additional evidence of imneskibart’s activity across difficult-to-treat, CPI-refractory tumors. In heavily pretreated patients with advanced adenocarcinoma NSCLC, the triplet regimen of imneskibart plus low-dose, subcutaneous aldesleukin and avelumab achieved a median PFS of 5.8 months, a confirmed ORR of 21% and a disease control rate (DCR) of 86%. Median overall survival (OS) had not been reached at a median follow-up of 10.6 months. Patients had received a mean of 2.6 prior lines of therapy, making these results particularly encouraging in a heavily pretreated population with limited remaining options. The 5.8-month median PFS compares favorably with the 3.6-month median PFS for docetaxel in the nonsquamous NSCLC subgroup of the randomized Phase 3 TROPION-Lung01 trial. Patients in the overall TROPION-Lung01 docetaxel arm had received an estimated mean of at least 1.5 prior lines of therapy, compared with 2.6 prior lines in the Aulos adenocarcinoma cohort, underscoring the substantial prior treatment exposure in the Aulos study. These cross-trial comparisons are descriptive and do not establish comparative superiority.

"We believe these are exceptional results for imneskibart in two of the most challenging populations in oncology – melanoma and NSCLC patients whose tumors have progressed despite multiple prior treatments," said Aron Knickerbocker, President and Chief Executive Officer of Aulos Bioscience. "With deep and durable tumor responses, consistent pharmacodynamic activity and manageable safety profiles, these findings provide a compelling foundation for advancing into randomized clinical trials and reinforce our confidence in imneskibart’s differentiated mechanism and its potential to become an important new treatment option in both melanoma and lung cancer."

As of the September 18, 2026 data cutoff, data were available from 51 melanoma patients in the Phase 1 and Phase 2 cohorts, with and without nivolumab, of whom 14 were evaluable for response in the imneskibart doublet cohort and 18 were evaluable for response in the imneskibart triplet cohort. In NSCLC, data were available from 26 patients (with adenocarcinoma or squamous histology) in the Phase 2 avelumab combination cohort, 16 of adenocarcinoma histology, of whom 14 were evaluable for response. Key findings are summarized below.

Remarkable progression-free survival and durable anti-tumor activity in doublet CPI-refractory melanoma, with ongoing deep tumor reductions observed with imneskibart triplet and doublet regimens

Imneskibart triplet regimen:

Median PFS of 9.1 months in patients who received a mean of 2.7 prior lines of therapy.
28% ORR, including one confirmed complete response and four partial responses of -81%, -74%, -65% and -40%.
All but four patients had liver and/or lung metastases at baseline, including all patients who achieved a partial response.
Median OS data remained immature, with 16 of 20 patients alive or censored at the data cutoff and a median follow-up of 5.6 months.
Imneskibart doublet regimen:

Median PFS of 6.9 months in patients who received a mean of 2.4 prior lines of therapy.
29% ORR, with four of 14 patients with the deepest target tumor reductions continuing on treatment for more than one year: -48% (on study for 13 months), -47% (continues on study for 14+ months) and a confirmed complete response (-100%; continues on study, now in follow-up, for 32+ months). One patient with measurable non-target tumors had a -58% reduction in tumor size (on study for 18.5 months).
Nine of 14 patients achieved stable disease.
Median OS was 16.1 months at a median follow-up of 18 months.
Exceptional progression-free survival exceeding historical chemotherapy benchmarks in CPI-refractory advanced adenocarcinoma NSCLC observed with imneskibart triplet

Median PFS of 5.8 months.
21% ORR, with three of 14 patients achieving target tumor reductions of -42% (on study for eight months), -43% (continues on study for 12+ months) and -45% (on study for six months).
Nine of 14 patients achieved stable disease, resulting in an 86% disease control rate.
Patients had received a mean of 2.6 prior lines of therapy before entering the study.
Median OS was not reached at a median follow-up of 10.6 months.
Pharmacodynamic findings continue to support imneskibart’s differentiated mechanism of action

In melanoma, treatment produced sustained reductions in regulatory T cells (Tregs) and increases in CD8/Treg ratios. Patients with Treg reductions greater than the median reduction of 56% experienced longer time to progression than patients with smaller reductions.
Across the melanoma triplet and doublet regimens, durable increases in CD8 T cells and CD8/Treg ratios were accompanied by corresponding decreases in Tregs, supporting imneskibart’s mechanism of redirecting interleukin-2 (IL-2) toward immune effector cells and away from immunosuppressive Tregs.
In NSCLC, CD8/Treg ratios and natural killer (NK) cells increased from baseline substantially, with greater increases associated with longer PFS.
The increase in NK cells may complement avelumab’s antibody-dependent cellular cytotoxicity (ADCC) activity. Avelumab is an anti-PD-L1 antibody with an active Fc domain and ADCC effector function mediated by NK cells; on average, imneskibart increased NK cell counts nearly three-fold from baseline.
Imneskibart-based regimens continue to demonstrate manageable safety profiles

Most drug-related adverse events were Grade 1 or 2 with imneskibart and low-dose, subcutaneous aldesleukin, alone or in combination with nivolumab or avelumab.
No capillary leak syndrome or treatment-related deaths were observed.
The emerging safety profile of the doublet and triplet regimens in melanoma and NSCLC is consistent with the known safety profiles of nivolumab and avelumab with imneskibart plus aldesleukin, with no new toxicity signals observed.
Enrollment is complete in all Phase 2 cohorts evaluating nivolumab or avelumab plus imneskibart and low-dose, subcutaneous aldesleukin.

The posters, "Imneskibart, a human monoclonal antibody (mAb), + low-dose subcutaneous IL-2 + avelumab: Phase 2 promising activity in CPI-refractory adenocarcinoma non-small cell lung cancer (NSCLC)" (Abstract 605) and "Imneskibart + low-dose subcutaneous IL-2 ± nivolumab in doublet checkpoint inhibitor-refractory melanoma: promising activity in an ongoing Phase 1/2 study" (Abstract 611) are accessible to meeting registrants as an electronic poster on the SITC (Free SITC Whitepaper) Annual Meeting virtual platform. They are also available on the Aulos Bioscience website in the Abstracts and Publications section.

To learn more about the imneskibart clinical trial program, please visit ClinicalTrials.gov (identifier: NCT05267626). For patients and providers in the U.S., please visit www.solidtumorstudy.com. For patients and health professionals in Australia, please visit www.solidtumourstudy.com.

About Imneskibart
Imneskibart (AU-007) is a human IgG1 monoclonal antibody designed by leveraging artificial intelligence that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, imneskibart redirects IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by effector T cells, from binding to trimeric receptors on regulatory T cells while still allowing IL-2 to bind and expand effector T cells and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. Imneskibart also prevents IL-2 from binding to CD25-containing receptors on eosinophils, as well as vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy.

(Press release, Aulos Bioscience, NOV 6, 2026, View Source [SID1234674387])

On November 5, 2026 Celcuity Inc. (Nasdaq: CELC), a commercial-stage biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications, reported financial results for the third quarter ended September 30, 2026, and other recent business developments.

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Celcuity announced on September 30, 2026, that REVTORPYK (gedatolisib) became commercially available in the United States for use in combination with fulvestrant, with or without palbociclib, for the treatment of HR+/HER2- locally advanced or metastatic breast cancer ("ABC") without a PIK3CA mutation detected following progression on or after at least one line of endocrine therapy in the metastatic setting.

"Our commercial and medical affairs teams have laid the foundation for a strong launch over the past few years, and their efforts are paying off," said Brian Sullivan, CEO and co-founder of Celcuity. "Physicians are enthusiastic and eager to treat their patients with REVTORPYK, and we are pleased with their interest in getting eligible patients on treatment in the initial weeks since we launched."

"We estimate over 90% of commercial and Medicare lives are in health plans that cover REVTORPYK. The unprecedented efficacy results from the wild-type cohort of the pivotal VIKTORIA-1 study, and the preferred Category 1 recommendation in the NCCN Guidelines, provide physicians with a compelling value proposition to address a significant unmet need for the tens of thousands of patients affected each year by HR+/HER2-, PIK3CA wild-type advanced breast cancer."

Business Highlights and Other Recent Developments

2nd Line HR+/HER2- ABC – PIK3CA wild-type

•
FDA approval. On July 14, 2026, the US Food and Drug Administration ("FDA") approved REVTORPYK for the treatment of patients with HR+/HER2- ABC without a PIK3CA mutation detected following progression on or after at least one line of endocrine therapy in the metastatic setting.
•
NCCN preferred Category 1 recommendation. On July 30, 2026, NCCN included REVTORPYK as a preferred Category 1 recommendation for second-line and/or subsequent-line therapy for the treatment of patients with HR+/HER2- advanced breast cancer without a PIK3CA mutation following progression on or after at least one line of endocrine therapy.
•
Early launch off to a positive start. 78% of the top 36 strategic accounts, representing ~50% of the total addressable patient population, have ordered REVTORPYK. Over 3,400 sites, many of which are affiliated with one of the top 36 strategic accounts, have directly engaged with Celcuity oncology sales specialists. These sites treat 82% of breast cancer patients. Additionally, over 1,100 health care providers have attended REVTORPYK educational programs.
•
Broad payor coverage and major provider pathway inclusion. 91% of U.S. commercial and Medicare lives are in health plans that cover REVTORPYK, and REVTORPYK has already been incorporated in 3 of the 4 largest health care provider pathways.
2nd Line HR+/HER2- ABC – PIK3CA mutant-type

In October, updated results from the Phase 3 VIKTORIA-1 study were presented in a late breaking rapid oral presentation at the European Society for Medical Oncology ("ESMO") Congress 2026. Key results included:

•
Median progression-free survival ("PFS") was 21.5 months with the gedatolisib triplet (gedatolisib + fulvestrant + palbociclib) and 11.5 months with the gedatolisib doublet (gedatolisib + fulvestrant) versus 9.1 months with alpelisib + fulvestrant in patients who had no liver metastases.

•
Objective response rate ("ORR") and median duration of response for patients with evaluable disease were 59% and 19.4 months, respectively, for the gedatolisib triplet and 43% and 27.8 months, respectively, for the gedatolisib doublet, compared to 33% and 7.5 months, respectively, for alpelisib + fulvestrant.
•
The discontinuation rate for gedatolisib due to adverse events was 5% and 4% with the gedatolisib triplet and doublet, respectively, compared to 19% for alpelisib + fulvestrant.
Based on the positive data from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 study, Celcuity submitted a supplemental New Drug Application ("sNDA") to the FDA in the third quarter of 2026. Celcuity expects to submit VIKTORIA-1 Phase 3 data for both the wild-type and mutant cohorts to global regulatory authorities later this year or early next year.

1st Line HR+/HER2- ABC

•
VIKTORIA-2. Enrollment is ongoing in the Phase 3 VIKTORIA-2 clinical trial that is evaluating gedatolisib combined with palbociclib and fulvestrant in the first-line setting for patients with endocrine resistant HR+/HER2- ABC (Study 1) or gedatolisib combined with palbociclib and letrozole in the first-line setting for patients with endocrine sensitive HR+/HER2- ABC (Study 2).
Metastatic Castration-Resistant Prostate Cancer ("mCRPC")

Updated data from a Phase 1b/2 study evaluating gedatolisib plus darolutamide in men with mCRPC were presented at a poster session at the ESMO (Free ESMO Whitepaper) Congress 2026. Key results included:

•
Median radiographic progression free survival ("rPFS") was 15.7 months and the six-month rPFS rate ("rPFS6") was 82.2% in patients with prior exposure to abiraterone. Median rPFS was 9.1 months and rPFS6 was 62.5% in patients with prior exposure to enzalutamide.
•
Prostate-specific antigen ("PSA") ≥50% decreases from baseline were observed across all dose levels; response rates were 36%, 47% and 67% at the 120-, 180-, and 240-mg gedatolisib dose levels, respectively, in patients with prior exposure to either abiraterone or enzalutamide.
•
Gedatolisib plus darolutamide demonstrated a manageable safety profile across the evaluated dose levels (120 mg, 180 mg, 240 mg) with one dose-limiting toxicity (Grade 3 rash), no Grade 4/5 treatment-related adverse events ("TRAEs"), and no TRAEs leading to treatment discontinuation or death. Grade 3 TRAEs occurred in 20% of patients with only rash and pruritus occurring in more than one patient.
•
The randomized Phase 2 study to evaluate the efficacy and safety of, and determine the recommended Phase 3 dose level of, gedatolisib in combination with darolutamide in patients with prostate cancer is expected to begin in the first half of 2027.
New Senior Management

Byron Robinson, Ph.D., J.D., joined Celcuity as Chief Strategy Officer to support development of strategic clinical and business development plans. Byron has served for more than 30 years in a variety of executive roles with responsibility for drug discovery, global clinical development, program leadership, portfolio strategy, market intelligence and competitive analytics. His experience includes senior executive roles at both small and large biotech and pharma companies including Janux Therapeutics, Merck KGaA, Bayer AG, and Amgen.

Third Quarter 2026 Financial Results

Unless otherwise stated, all comparisons are for the third quarter ended September 30, 2026, compared to the third quarter ended September 30, 2025.

Net loss for the third quarter of 2026 was $73.3 million, or $1.33 per share, compared to a net loss of $43.8 million, or $0.92 per share, for the prior year period. Non-GAAP adjusted net loss for the third quarter of 2026 was $66.8 million, or $1.21 per share, compared to non-GAAP adjusted net loss of $37.2 million, or $0.78 per share, for the prior year period. Non-GAAP adjusted net loss excludes stock-based compensation expense, non-cash interest expense and non-cash investment income. Because these items have no impact on Celcuity’s cash position, management believes non-GAAP adjusted net loss better enables Celcuity to focus on cash used in operations. For a reconciliation of financial measures calculated in accordance with generally accepted accounting principles in the United States ("GAAP") to non-GAAP financial measures, please see the financial tables at the end of this press release.

Shipments of REVTORPYK commenced on September 30, 2026. We recognize revenue when control of REVTORPYK transfers to the healthcare providers or pharmacies, which generally occurs upon delivery. Because no product was received by the healthcare providers or pharmacies until after September 30, 2026, we did not recognize any product revenue during the third quarter ended September 30, 2026.

Total operating expenses were $77.3 million for the third quarter of 2026, compared to $42.8 million for the prior year period.

Research and development ("R&D") expenses were $37.5 million for the third quarter of 2026, compared to $30.4 million for the prior year period. The $7.1 million increase in R&D expenses was primarily due to a $5.3 million increase in employee-related and consulting expenses, of which $1.5 million related to stock-based compensation, and a $2.1 million increase in manufacturing and other costs. These increases were partially offset by a $0.3 million decrease in clinical trial costs.

Selling, general and administrative ("SG&A") expenses were $39.8 million for the third quarter of 2026, compared to $12.4 million for the prior year period. The $27.4 million increase in SG&A expenses was primarily due to a $14.4 million increase in employee-related expenses, of which $1.7 million related to stock-based compensation. The increase in employee-related expenses was primarily driven by the hiring of additional personnel to support the commercialization of REVTORPYK. The remaining $13.0 million increase was primarily due to an $11.1 million increase in costs to support the commercialization of REVTORPYK, including consulting expenses and expanding infrastructure costs, and a $1.9 million increase in other administrative expenses. In the aggregate, $25.3 million of the $27.4 million SG&A increase related to commercial headcount additions and other activities to support the commercialization of REVTORPYK.

Net cash used in operating activities for the third quarter of 2026 was $66.2 million, compared to $44.8 million for the prior year period. In addition, we made a $50.0 million payment to Pfizer triggered by receipt of FDA approval for REVTORPYK per our exclusive global license agreement for gedatolisib. Cash, cash equivalents and short-term investments were $642.7 million at the end of the third quarter of 2026. We expect that our current cash, cash equivalents and short-term investments will finance our operations through 2029.

Webcast and Conference Call Information

To participate in the teleconference, domestic callers should dial 1-800-717-1738 and international callers should dial 1-646-307-1865.

A live webcast presentation can also be accessed using this weblink: View Source;tp_key=e66abcfe8a. A replay of the webcast will be available on the Celcuity website following the live event.

About REVTORPYK (gedatolisib)

REVTORPYK (gedatolisib) is a kinase inhibitor indicated in combination with fulvestrant, with or without palbociclib, for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.

Please click here for Important Safety Information and Full Prescribing Information for REVTORPYK.

(Press release, Celcuity, NOV 5, 2026, View Source [SID1234674389])

On November 5, 2026 Alethio Therapeutics ("Alethio"), a biopharmaceutical company developing next-generation therapies for myeloproliferative neoplasms (MPNs), reported the successful completion of an oversubscribed $90 million (£67 million) Series A financing.

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The substantial round was co-led by new investors Sofinnova Partners and RA Capital, alongside founding investor Oxford Science Enterprises, with additional support from Cancer Research Horizons and the University of Oxford. In conjunction with the financing, Graziano Seghezzi, Managing Partner at Sofinnova Partners, and Maxwell DeNies from RA Capital have been appointed to Alethio’s Board of Directors.

The proceeds of the financing will enable Alethio to transition into a clinical-stage company, with capital deployed to advance its lead programme, ATX-011, through completion of Phase 1/2a studies in essential thrombocythaemia (ET), up to Phase 3 readiness, while also progressing additional MPN programmes towards IND submission.

"Too often, a patient’s first encounter with ET is a thrombotic event that lands them in the emergency room," said Dr Rohit Batta, Chief Executive Officer of Alethio Therapeutics. "What follows is typically lifelong treatment with therapies that can cause burdensome side effects and are associated with high rates of resistance. Alethio was founded on a simple conviction – if you can selectively eliminate the cells driving disease, you can redefine what is possible for patients. This financing enables us to turn that conviction into reality."

Founded as a spin-out from the University of Oxford by Professors Adam Mead and Beth Psaila, two of the world’s leading physician-scientists in MPNs, Alethio is building a pipeline of novel therapies informed by their deep expertise in MPN biology. MPNs, including ET, are blood cancers characterised by the uncontrolled production of blood cells and an increased risk of thrombosis, bone marrow scarring (myelofibrosis), and transformation to acute leukaemia.

Current therapies for ET are non-targeted treatments that have been around for decades such as hydroxycarbamide and interferon, that can affect, and disproportionately damage, healthy cells. Alethio is pursuing a different approach, developing targeted therapies designed to selectively eliminate the disease-driving cells that sustain MPNs, to modify the underlying disease features and restore healthy blood counts, reduce thrombotic risk and ultimately improve outcomes for patients.

Preclinical data for ATX-011 has been selected for oral presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2026 Annual Meeting, underscoring the strength of Alethio’s first-in-class G6B-targeting programme. ATX-011 is designed to normalise platelet counts in patients with ET by selectively enhancing platelet clearance through binding G6B, a protein expressed on platelets and megakaryocytes. Importantly, G6B is also aberrantly expressed on MPN-initiating stem cells, but not healthy stem cells, and on megakaryocytes implicated in the development of bone marrow fibrosis. These findings support the potential of ATX-011 to deliver broad therapeutic benefit across patients with MPNs irrespective of driver mutation. Alethio is advancing ATX-011 through IND-enabling studies and toward clinical development in ET.

"The most transformative companies are built around insights that challenge long-held assumptions in medicine," said Graziano Seghezzi, Managing Partner at Sofinnova Partners. "In MPNs, the field has long accepted that controlling the disease is enough. Alethio challenges that assumption. By targeting the cells that drive the disease, its approach has the potential to move patients beyond symptom management toward true disease modification. All of this is based on an exceptional team and founders with a deep understanding of the disease."

"We were drawn to the strength of the biology underpinning Alethio’s approach," said Maxwell DeNies, from RA Capital. "G6B is a highly differentiated target with compelling human data supporting its role in selectively identifying disease-driving cells in MPN. Combined with the extensive patient-derived validation generated by the team, this creates a strong scientific foundation for the programme as it advances toward the clinic."

"Since its formation, Alethio has made incredible progress in translating pioneering University of Oxford science into a focused and ambitious biotechnology company," said Sally Dewhurst, Principal at Oxford Science Enterprises. "The team has built not only a promising lead programme but also the ARTEMIS discovery platform, providing a powerful engine for future pipeline innovation. We are proud to continue supporting the company and are delighted to welcome such an experienced syndicate to help Alethio transition to the next stage of growth; delivering meaningful impact for patients in the clinic."

(Press release, Alethio Therapeutics, NOV 5, 2026, View Source [SID1234674377])

On November 5, 2026 T-Therapeutics, a biotechnology company developing next-generation T cell receptor (TCR) T cell engager (TCE) therapeutics for cancer and autoimmune diseases, reported the closing of an oversubscribed $133 million Series B financing to fund the clinical development of its first-in-class TCR-CD3 bispecific lead programmes in oncology and autoimmune disease.

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The financing was co-led by Advent Life Sciences and British Business Bank with participation from other new investors, JJDC, Samsara BioCapital, M-Ventures and Eli Lilly and Company (Lilly), alongside all existing major shareholders, Sofinnova Partners, F-Prime, Digitalis Ventures, Cambridge Innovation Capital, Sanofi Ventures, Tencent and BGF.

Proceeds from the financing will support entry into the clinic and the generation of clinical proof-of-concept data for T-Therapeutics’ two lead programmes in cancer and autoimmune diseases. Both programmes leverage the company’s unique, proprietary OpTiMus platform, which provides an unparalleled supply of fully human TCRs, enabling access to validated, but previously undruggable, intracellular targets.

T-Therapeutics’ lead oncology programme offers broad therapeutic potential across the largely untapped solid tumour space. In immunology, the company is deploying its platform to drive a novel, precision approach to immune reset, through the selective depletion of pathogenic cells that drive chronic tissue inflammation. Both programmes have the potential to address multiple indications and to meaningfully improve patient outcomes where there are currently limited treatment options.

Following this financing, representatives from Advent Life Sciences, British Business Bank, JJDC and Samsara BioCapital will join T-Therapeutics’ Board as non-executive directors.

Alongside the Series B financing, T-Therapeutics has further strengthened its leadership team with the appointment of Dr. Kirsty Crame as Chief Development Officer to oversee the translational and clinical development of the company’s pipeline. Dr. Crame previously served as Chief Medical Officer at Curatis AG and brings over 15 years’ experience in novel biopharmaceutical development. She led multiple early-stage clinical programmes at Medigene AG and Gadeta BV, and has particular expertise in TCR-based therapeutics.

Theodora Harold, Chief Executive Officer of T-Therapeutics, said:
"This financing is a key step in our transition to a clinical-stage company, enabling us to accelerate the development of two oncology and immunology programmes with pan-indication, blockbuster potential, underpinned by a platform that reaches targets long considered undruggable. The further strengthening of our team with the appointment of Dr. Kirsty Crame, and the proceeds from this raise, position us well for rapid execution of those programmes and the delivery of important clinical proof-of-concept data. My thanks to our new and longstanding investors, whose confidence in our science enables a next generation of T cell engager therapeutics."

Dominic Schmidt, General Partner at Advent Life Sciences, added:
"T cell engagers have delivered clinical success in haematological cancers but have been held back in solid tumours by the lack of appropriate targets. By unlocking previously undruggable intracellular targets, with the potential for a markedly improved safety profile, T-Therapeutics’ platform brings the promise of this treatment/modality to solid tumours, where the great majority of cancers arise."

Dr. Kirsty Crame, newly appointed Chief Development Officer of T-Therapeutics, said:
"I am delighted to join T-Therapeutics at this pivotal moment for the Company. I look forward to advancing our clinical strategy and first-in-class programmes, and to realising the potential of our platform technologies to address major therapy areas with significant unmet patient need."

(Press release, T-Therapeutics, NOV 5, 2026, View Source [SID1234674376])