Lyell Immunopharma Announces Participation in May Investor Conferences

On May 12, 2026 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing a pipeline of next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, reported that members of its senior management team will participate in the following investor conferences:

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H.C. Wainwright 4th Annual BioConnect Investor Conference on Tuesday, May 19, 2026, in New York City, New York; fireside chat at 11:00 am Eastern Time
2026 Stifel Virtual Targeted Oncology Forum on Wednesday, May 20, 2026; fireside chat at 4:00 pm Eastern Time

A live webcast of each fireside chat can be accessed through the Investors section of the Company’s website at www.lyell.com. A replay of each webcast will be available on the Company’s website following each event.

(Press release, Lyell Immunopharma, MAY 12, 2026, View Source [SID1234665546])

Sana Biotechnology Presents Preclinical Data for In Vivo CAR T Cell Therapy SG293 Surrogate Demonstrating Cell-Specific Delivery, Potent CAR T Cell Generation, and Deep B Cell Depletion in NHPs

On May 12, 2026 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, reported the presentation of preclinical data demonstrating that a surrogate SG293, an in vivo CAR T cell therapy, achieved cell-specific delivery, robust and dose-dependent CAR T cell generation, and deep B cell depletion in non-human primates (NHPs) without the use of lymphodepleting chemotherapy. SG293 is a CD8-targeted fusosome that delivers the genetic material to make CD19-directed CAR T cells. The data were reported in an oral presentation at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 2026 Annual Meeting.

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"SG293 represents a differentiated in vivo CAR T cell approach designed to work without lymphodepletion to deliver potent therapeutic activity and exceptional specificity to minimize off-target effects," said Dhaval Patel, MD, PhD, Executive Vice President, Chief Scientific Officer. "Data presented at ASGCT (Free ASGCT Whitepaper) highlight the fusogen platform’s potential to enable development of therapies that offer off-the-shelf treatment options for patients with blood cancers, B cell-mediated autoimmune disorders, and multiple myeloma. The data support our strategy of advancing SG293 into the clinic for the treatment of non-Hodgkin lymphoma (NHL) later this year and SG227, a BCMA-targeted in vivo CAR T cell therapy, into the clinic for the treatment of multiple myeloma as early as mid-2027."

In an NHP model, a one-time intravenous administration of the surrogate SG293 led to potent CAR T cell generation, dose-dependent CAR T cell expansion, and complete peripheral B cell depletion. At 3 weeks, B cells were undetectable or minimally detectable in lymph nodes, and as B cells returned after depletion, the vast majority exhibited a naïve phenotype indicative of a "reset" of the B cell compartment. The targeted fusogen used in SG293 demonstrates a differentiated level of protection from off-target delivery risks in vitro when compared to other targeted fusogen technologies. The specific delivery and favorable on-target safety profile were confirmed in vivo in NHPs with surrogate SG293. Post-necropsy analysis of tissues showed no evidence of delivery to non-target cells, including hepatocytes, heart, or gonadal tissue. Post-infusion symptoms were mild and managed with acetaminophen, and CAR T-associated toxicities were manageable and consistent with autologous CAR T toxicities in this NHP model. Finally, the novel transgene design used in SG293 diminishes CAR protein incorporation onto the vector during manufacturing, which mitigates anti-CAR immunogenicity in NHPs and may enable improved durability of in vivo CAR T cells. These data demonstrate that SG293 represents a differentiated approach for enabling potent and precise in vivo CAR T cell therapy for oncology and autoimmune indications. Sana intends to explore SG293 initially in NHL and expects to generate first-in-human data as early as this year. If successful, the company intends to expand clinical development with SG293 into B cell-mediated autoimmune diseases and to initiate clinical development of SG227 for patients with multiple myeloma.

About SG293
SG293, which uses Sana’s proprietary fusogen-based in vivo delivery technology, is a CD8-targeted fusosome that delivers to CD8+ T cells the genetic material to make CD19-directed CAR T cells while avoiding potentially troublesome delivery to tissues such as the liver, heart, and gonadal tissue. Sana intends to explore SG293 in both B cell cancers and B cell-mediated autoimmune diseases.

About SG227
SG227, which uses Sana’s proprietary fusogen-based in vivo delivery technology, is a CD8-targeted fusosome that delivers to CD8+ T cells the genetic material to make BCMA-directed CAR T cells while avoiding potentially troublesome delivery to tissues such as the liver, heart, and gonadal tissue. Sana intends to explore SG227 as a potential therapy for the treatment of multiple myeloma.

(Press release, Sana Biotechnology, MAY 12, 2026, View Source [SID1234665558])

SkylineDx to Showcase New Cutaneous Squamous Cell Carcinoma Findings at 83rd Society for Investigative Dermatology Annual Meeting

On May 12, 2026 SkylineDx, an innovative company specializing in molecular diagnostics for dermatology, reported data from two oral and one e-poster presentation, focusing on CSCC, at the 83rd Society for Investigative Dermatology Annual Meeting, taking place May 13-16, in Chicago. The presentations will showcase findings from a comprehensive genomic and transcriptomic characterization of CSCC, including driver mutations and genetic alterations in HLA class I genes, and a new gene expression signature associated with metastatic risk.

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CSCC is the second most common form of skin cancer worldwide1, and while most tumors are not life-threatening, 2-5% of patients develop metastases². A major unmet clinical need is to identify this subset of patients who will eventually develop metastatic disease. Achieving this has been challenging because CSCC is not included in most cancer registries and was left out of large-scale consortia projects. Within the framework of an international collaboration of top research institutions, the Erasmus Medical Center, Rotterdam, the University of California, San Francisco, and SkylineDx sought to characterize the genomic and transcriptomic drivers of CSCC metastasis to inform future development in clinical settings.

Oral Presentations:

"Comprehensive genomic characterization of cutaneous squamous cell carcinoma"

To better understand what causes some CSCCs to progress to metastatic disease, four national databases in the Netherlands were integrated to assemble a cohort of clinically annotated tumors linked to outcome. RNA-sequencing was performed on 366 tumors, and whole-exome sequencing was performed on 147 tumors. Findings provide a new, more detailed molecular picture of CSCC and identify which biomarkers can be associated with poor prognosis – providing better insights into tumor biology.

"Genetic alterations of HLA class I genes in cutaneous squamous cell carcinoma"

CSCCs exhibit high mutation burden and are highly immunogenic; however, mutations affecting antigen presentation have not been systematically characterized. To address this knowledge gap, the role of germline HLA diversity in cancer susceptibility was first examined. Next, it was investigated whether HLA genes are also subject to somatic selection during CSCC tumorigenesis. The findings suggest that a reduced baseline capacity for antigen presentation, inherited by germline HLA alleles, and/or the acquired loss of antigen presentation, through somatic alterations, promote keratinocyte carcinogenesis.

E-Poster:

"Gene expression predicts metastatic risk in low-risk cutaneous squamous cell carcinoma."

SCCore GEP, a novel gene expression signature for CSCC, addresses the need for improved metastatic risk stratification, as more than one-third of metastases occur in patients initially classified as "low risk" (T1, T2a), which represents 90% of patients. This SCCore GEP gene expression signature may enable more precise risk stratification by revealing biological risk factors that extend beyond traditional clinical and pathological features as represented by the staging systems.

"The Cancer Genome Atlas and other large-scale sequencing consortia overlooked CSCC, despite it being one of the most common forms of cancer Worldwide. Our study is the largest omics characterization of CSCC to date, which will serve as a major resource to the research community," said Hunter Shain, Associate Professor, Department of Dermatology and Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco. "Already, we have discovered promising biomarkers that complement and/or outperform established staging systems. I look forward to seeing how else this rich dataset will foster discovery in this historically neglected area of cancer research."

"CSCC patients stand to benefit from an improved risk stratification that can identify those at highest risk of poor outcomes, such as metastasis3," said SkylineDx CEO Dharminder Chahal. "Building on our experience in melanoma, we are striving to develop molecular diagnostic solutions for CSCC that enhance currently available risk stratification measures such as staging systems and nomograms based on clinicopathological factors, to ultimately improve patient outcomes."

(Press release, SkylineDx, MAY 12, 2026, View Source [SID1234665574])

Disc Medicine Announces Multiple Presentations Across Portfolio at the European Hematology Association (EHA) 2026 Congress

On May 12, 2026 Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, reported that it will present data from multiple programs in its hematology portfolio, including an oral presentation of data from the RALLY-MF phase 2 trial of DISC-0974 in anemia of myelofibrosis (MF), at the upcoming European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress, which will be held in Stockholm, Sweden on June 11-14, 2026.

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"We look forward to presenting an update from our RALLY-MF trial at EHA (Free EHA Whitepaper), highlighting consistently strong anemia response rates across MF subpopulations and background therapies" said John Quisel, J.D., Ph.D., President and Chief Executive Officer of Disc Medicine. "We will also present updates on our EPP program, including new data from the HELIOS open label extension study of bitopertin in EPP and data from the European cohort of the EPP LIGHT survey, ahead of the expected readout of the APOLLO Phase 3 trial of bitopertin in EPP later this year."

The oral presentation of data from the Phase 2 RALLY-MF study in patients with anemia of MF will cover N=61 patients with data through April 27, 2026. At the time of the abstract deadline, there were N=43 evaluable patients. Major response rates among evaluable patients at the abstract cutoff were 54% (15/28) for the non-transfusion dependent cohort, 67% (6/9) for the lightly transfused (TD Low) cohort, and 50% (3/6) for the heavily transfused (TD High) cohort. Overall response (major response + minor response) was 70%, with similar response regardless of concomitant JAK inhibitor therapy. Additional data and analyses will be included in the presentation at EHA (Free EHA Whitepaper).

Management will host a call following the EHA (Free EHA Whitepaper) meeting to review highlights of the presented data and next steps for the company on Monday, June 15 at 8:00am EDT. Please register for the event on the Events and Presentations page of Disc’s website (View Source).

Bitopertin, DISC-0974, and DISC-3405 are investigational agents and are not approved for use as therapies in any jurisdiction worldwide.

Details of Presentations and Abstracts:

DISC-0974 Oral Presentation:

Abstract Number: S306
Abstract Title: RALLY-MF: Initial efficacy of a phase 2 study of DISC-0974, an anti-hemojuvelin antibody, to treat anemia in myelofibrosis
Session Title: S430 From erythropoiesis to transfusion practice
Session Details: Friday, June 12 (5:15pm – 6:30pm CEST / 11:15am – 12:30pm EDT)
Presenting Author: Naseema Gangat, M.B.B.S.

Bitopertin Abstracts:

Abstract Code: PS2394 (Poster Presentation)
Abstract Title: Additional safety and efficacy results from HELIOS: A phase 2, open-label, long-term extension study of bitopertin in erythropoietic protoporphyria
Session Details: Saturday, June 13 (6:45pm – 7:45pm CEST / 12:45pm – 1:45pm EDT)
Presenting Author: Amy Dickey, M.D., MSc

Abstract Code: PB4415 (Publication Only)
Abstract Title: Erythropoietic protoporphyria life impact and genetic health trajectory (EPP LIGHT) study: a cross-sectional survey of adults and adolescents in Europe

DISC-3405 Abstract:

Abstract Code: PF909 (Poster Presentation)
Abstract Title: RESTORE-PV – a phase 2 open-label study evaluating the safety and efficacy of the anti-TMPRSS6 monoclonal antibody DISC-3405 in participants with polycythemia vera
Session Details: Friday, June 12 (6:45pm – 7:45pm CEST / 12:45pm – 1:45pm EDT)
Presenting Author: Naseema Gangat, M.B.B.S.

(Press release, Disc Medicine, MAY 12, 2026, View Sourcenews-releases/news-release-details/disc-medicine-announces-multiple-presentations-across-3 [SID1234665534])

Medicenna and Fondazione Melanoma Onlus Announce First Patient Dosed in the NEO-CYT Study of MDNA11 in Neoadjuvant Melanoma

On May 12, 2026 Medicenna Therapeutics Corp. ("Medicenna" or the "Company") (TSX: MDNA, OTCQX: MDNAF), a clinical-stage immunotherapy company developing Superkines for targeting cancer and autoimmune disease, reported that the first patient has been dosed in the NEO-CYT study, a randomized, investigator-initiated neoadjuvant Phase 1b trial evaluating MDNA11, Medicenna’s long-acting, "beta-enhanced not-alpha" IL-2 Superkine, in combination with nivolumab, with or without ipilimumab, in patients with high-risk, surgically resectable Stage III cutaneous melanoma at up to 12 centers in Italy.

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"Neoadjuvant therapy has demonstrated that the timing of immunotherapy can be critical," said Professor Paolo A. Ascierto, Lead Principal Investigator of NEO-CYT. "Treating patients while the tumor is still present may generate deeper and more durable immune responses. NEO-CYT is designed to investigate whether MDNA11, a next-generation IL-2 Superkine, may potentiate the immune activity of nivolumab, with or without ipilimumab, leading to improved pathologic responses and potentially higher cure rates in patients with resectable, high-risk melanoma."

The NEO-CYT study is designed to evaluate MDNA11 as neoadjuvant immunotherapy before curative-intent surgery in earlier-stage melanoma patients whose immune systems may be more amenable to immunotherapy and more likely to benefit from treatment. MDNA11 will be evaluated in combination with nivolumab, with or without ipilimumab, with major pathologic response as a primary endpoint, which is considered predictive of long-term survival outcomes.

NEO-CYT is sponsored by the non-profit Melanoma Foundation, Fondazione Melanoma Onlus and is led by Professor Paolo A. Asciert of the Istituto Nazionale Tumori IRCCS ‘Fondazione G. Pascale.’ Under the terms of the clinical trial collaboration, Fondazione Melanoma Onlus is the Sponsor and Medicenna is supplying the study medications.

"Dosing the first patient in the NEO-CYT study represents an important milestone in the continued clinical development of MDNA11 and expands our evaluation of this next-generation IL-2 Superkine into the neoadjuvant setting," said Dr. Nageatte Ibrahim, Chief Medical Officer of Medicenna. "MDNA11 has already demonstrated encouraging anti-tumor activity and a manageable safety profile in heavily pretreated patients with advanced metastatic cancers in the ongoing ABILITY-1 study. NEO-CYT allows us to evaluate MDNA11 earlier in the treatment paradigm, where the immune system may be more intact and where pathologic response can provide an early and rigorous signal of clinical activity. We are honored to collaborate with Fondazione Melanoma Onlus and Professor Ascierto on this important study."

MDNA11 is currently being evaluated in the Phase 1/2 ABILITY-1 study as both monotherapy and in combination with pembrolizumab in patients with advanced solid tumors. In prior clinical updates, MDNA11 has demonstrated encouraging anti-tumor activity in heavily pretreated patients, including patients whose tumors progressed following immune checkpoint inhibitor therapy, alongside robust immune effector cell expansion and a manageable safety profile. NEO-CYT is intended to build on these findings by evaluating MDNA11 in an earlier-stage, potentially curative treatment setting.

About MDNA11

MDNA11 is a long-acting, ‘beta-enhanced not-alpha’ IL-2 Superkine specifically engineered to overcome the shortcomings of aldesleukin and other next generation IL-2 variants by preferentially activating immune effector cells (CD8+ T and NK cells) responsible for killing cancer cells, with minimal or no stimulation of immunosuppressive Tregs. These unique proprietary features of the IL-2 Superkine have been achieved by incorporating seven specific mutations and genetically fusing it to a recombinant human albumin scaffold to improve the pharmacokinetic (PK) profile and pharmacological activity of MDNA11 due to albumin’s natural propensity to accumulate in highly vascularized sites, in particular tumor and tumor draining lymph nodes. MDNA11 is currently being evaluated in the Phase 1/2 ABILITY-1 study as both monotherapy and in combination with pembrolizumab.

(Press release, Medicenna Therapeutics, MAY 12, 2026, View Source [SID1234665547])