On November 3, 2025 PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a hub-and-spoke biotherapeutics company dedicated to giving life to science and transforming innovation into value, reported that new data from its ongoing Phase 1b clinical trial evaluating LYT-200, a first-in-class anti-galectin-9 monoclonal antibody, in relapsed/refractory acute myeloid leukemia (AML) will be shared on December 6th, 2025, during the 67th Annual American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Orlando, Florida, by its Founded Entity Gallop Oncology. The accepted abstract reflects data as of July 8, 2025, and additional analyses based on a later data cut-off are expected to be presented during the ASH (Free ASH Whitepaper) meeting.

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The ongoing, open-label, dose-ranging trial is evaluating LYT-200 both as a monotherapy and in combination with the standard-of-care (SOC) regimen of venetoclax (VEN) and hypomethylating agents (HMA) in a very vulnerable population. All participants in the trial have previously been treated with SOC (median prior lines of treatment: 3; range: 1-7), and their disease had either returned or failed to respond.

The data submitted to ASH (Free ASH Whitepaper) reflect efficacy and safety findings for 31 participants in the monotherapy arm and 39 participants in the combination arm who received LYT-200 weekly at doses ≥7.5mg/kg. As a monotherapy, treatment with LYT-200 resulted in 1 marrow complete response (CR) and 3 partial responses (PRs). Notably, one PR in the monotherapy arm was maintained for 24 months as of the data cut off in an individual whose disease previously progressed following five prior rounds of treatment with SOC. When administered in combination with VEN/HMA, LYT-200 treatment resulted in 12 CRs, 1 PR, and 1 morphological leukemia-free state (MLFS). Importantly, CRs were achieved in this cohort across a diverse range of tumor subtypes, including KRAS, NRAS, HRAS, and JAK2 mutations, in patients who were previously fully refractory to SOC.

When evaluating patients with AML, a CR is the primary goal of treatment and means that no leukemia cells are detectable in the blood, fewer than 5% blasts remain in the bone marrow, and blood counts have returned to normal. Achieving a CR is generally associated with improved outcomes, including longer overall survival. A PR reflects a significant reduction in leukemia burden, with at least a 50% decrease in blasts, while an MLFS indicates that there are no leukemia cells visible and fewer than 5% blasts in the marrow, though blood counts have not yet recovered. While SOC in this advanced relapsed/refractory population typically achieves CR rates of 6-12% and median overall survival is less than 2.5 months,[1] LYT-200 has demonstrated a >30% CR rate in the combination cohort as of the data cut off, underscoring its potential to serve as a meaningful new treatment option.

Across all dose levels and treatment arms, LYT-200 was well tolerated. No dose-limiting toxicities were reported, and there were no LYT-200-related serious adverse events, discontinuations, or deaths. The most common adverse events potentially related to LYT-200 were mild and transient.

"The combination of this level of efficacy with a clean safety profile underscores the importance of advancing LYT-200 into its next phase of development, especially given the high relapse rates and poor survival outcomes in AML," said Luba Greenwood, JD, Chief Executive Officer of Gallop Oncology. "As survival data mature, we believe they could add another compelling dimension to LYT-200’s potential clinical profile for patients with relapsed/refractory AML, including those who have failed VEN/HMA or have mutations associated with poorer prognosis, where the need for new therapies remains urgent."

PureTech intends to share further matured data at ASH (Free ASH Whitepaper), including updated efficacy across dose levels, as well as survival and pharmacokinetic/pharmacodynamic data. Topline efficacy data are expected in the fourth quarter of 2025, with topline survival data anticipated in the first half of 2026. PureTech intends to engage with regulatory authorities to advance LYT-200 into a Phase 2 trial.

About AML and MDS

Acute myeloid leukemia (AML) is an aggressive blood cancer characterized by the rapid growth of abnormal myeloid cells in the bone marrow and blood. It is the most common form of acute leukemia in adults, with a five-year survival rate of less than 30%. Despite available therapies, many patients relapse or fail to respond, and outcomes are especially poor in the relapsed/refractory setting.

Myelodysplastic syndromes (MDS) are a group of rare blood cancers in which the bone marrow does not produce enough healthy blood cells. High-risk MDS often progresses to AML and is associated with limited treatment options and poor survival.

Together, AML and high-risk MDS represent areas of urgent unmet medical need where new therapies with improved efficacy and durability are critically needed. Importantly, the incidence of AML is increasing and the market is expected to grow to $6 billion by 2030, underscoring the scale of the opportunity to bring forward more effective therapies.

About LYT-200

LYT-200 is a fully human IgG4 monoclonal antibody targeting galectin-9, a key oncogenic driver and potent immunosuppressor in cancer. It is being developed for the potential treatment of hematological malignancies and solid tumors with otherwise poor survival rates. In an ongoing acute myeloid leukemia (AML) trial, LYT-200 has demonstrated clinical activity and disease stabilization in heavily pretreated patients, both as a monotherapy and in combination with standard-of-care therapy.

LYT-200 has been granted Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration (FDA) for the treatment of acute myeloid leukemia, underscoring the high unmet need in this disease and the potential for LYT-200 to serve as a meaningful therapeutic option.

(Press release, PureTech Health, NOV 3, 2025, View Source [SID1234659276])

On November 3, 2025 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS platform to develop in vivo gene editing therapies for high unmet need diseases, reported financial results for the third quarter ended September 30, 2025, and provided a business update.

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"Throughout the third quarter, we made strong progress across our gene editing pipeline and reported compelling Phase 1 safety and efficacy data for PBGENE-HBV at the International Coalition to Eliminate HBV Cure Symposium. We’re also eagerly awaiting a late-breaking oral presentation at AASLD on November 10th," said Michael Amoroso, Chief Executive Officer of Precision BioSciences. "The PBGENE-HBV data presented so far this year has shown proof of durable activity and a safety profile that allows us to continue dose escalation in pursuit of achieving a complete cure for hepatitis B patients. With great excitement, in 2026 we anticipate starting the first-in-human clinical trial with our second program, PBGENE-DMD for DMD patients, following our targeted IND submission by the end of 2025. We are highly encouraged by the unique preclinical data showing the potential to restore a nearly full length dystrophin gene which is native to the human body with the goal of improving function over time."

Wholly-Owned Portfolio:

PBGENE-HBV (Hepatitis B Viral Elimination Program):

On October 14th, Precision announced that it had been selected to deliver a late-breaking oral presentation at the upcoming Liver Meeting 2025 during the 75th American Association for the Study of Liver Diseases. The oral presentation will feature new data from the multiple cohorts of the ongoing Phase 1 ELIMINATE-B Trial.

On October 7th, Precision announced that the first clinical trial sites in the U.S. for the ELIMINATE-B trial had officially been activated. The site at Massachusetts General Hospital in Boston, Massachusetts, is now actively recruiting chronic hepatitis B patients along with multiple global clinical trial sites.

On September 12th, the Company presented data from the Phase 1 ELIMINATE-B trial of PBGENE-HBV at the 6th International Coalition to Eliminate HBV Cure Symposium in Berlin, Germany. To date, PBGENE-HBV has shown to be well-tolerated by patients in both Cohort 1 and Cohort 2, who received multiple doses of 0.2 mg/kg of PBGENE-HBV and 0.4 mg/kg, respectively. In addition, PBGENE-HBV has demonstrated a substantial HBsAg reduction in all patients across Cohort 1 with one patient in Cohort 1 achieving a durable HBsAg reduction of approximately 50% from baseline that was ongoing seven months following initial dose administration. Given the favorable safety profile of Cohorts 1 and 2, the Data Monitoring Committee recommended the Company to proceed with dosing Cohort 3 which occurred during the third quarter of 2025.

On September 8th, Precision announced the issuance of a U.S. Patent (No. 12,410,418) by the U.S. Patent and Trademark Office (USPTO) titled "Optimized engineered meganucleases having specificity for a recognition sequence in the Hepatitis B Virus genome." The composition of matter claims in the patent encompass the PBGENE-HBV ARCUS nuclease which has an expiration date in March 2042. Patents in Europe and Hong Kong granted earlier this year included similar composition of matter claims.

PBGENE-DMD (Muscle Targeted Excision Program):

On October 10th, the Company presented a late-breaking poster presentation at the 30th Annual International Congress of the World Muscle Society meeting highlighting durable improvements in muscle function over time through increased dystrophin expression and dystrophin-positive cells for PBGENE-DMD. The data from a DMD mouse model demonstrated that dystrophin protein was detected in all muscles evaluated following the administration of PBGENE-DMD at doses up to 1×1014 vg/kg, with increased expression observed at nine months versus prior timepoints in the quadriceps, gastrocnemius, heart, and diaphragm, resulting in substantial and sustained functional muscle improvement. An increase in dystrophin-positive muscle cells were observed in all muscles. The maximum force output was significantly improved over untreated DMD mice at three, six and nine months post-treatment, highlighting strong durability of PBGENE-DMD outcomes.

Precision has completed final toxicology studies and is manufacturing clinical supplies, with an anticipated IND filing by the end of 2025. Pending IND clearance, Phase 1 initiation in DMD patients is anticipated in the first half of 2026 with initial data expected to follow in the second half of 2026.

Partnered In Vivo Gene Editing Programs:

iECURE-OTC (Gene Insertion Program)

Led by partner, iECURE, ECUR-506 is an ARCUS-mediated in vivo targeted gene insertion program currently in a first-in-human trial (OTC-HOPE) evaluating ECUR-506 as a potential treatment for neonatal onset ornithine transcarbamylase (OTC) deficiency.

Several recent medical conference presentations with updated ECUR-506 clinical data include:

The 6th International Symposium on Urea Cycle Disorders and the 15th International Congress of Inborn Errors of Metabolism, both held in early September in Kyoto, Japan. In October, presentations at medical conferences included the European Society of Gene & Cell Therapy Annual Congress held in Sevilla, Spain, and the American Society of Human Genetics Annual Meeting in Boston, Massachusetts.

These data presentations build upon previously reported clinical results demonstrating complete clinical response in the first participant at the lowest dose level (1.3×1013 GC/kg) of ECUR-506, as defined by the study protocol. The OTC-HOPE study is ongoing in the U.K., the U.S., Australia, and Spain with data from the trial expected in the first half of 2026.

Non-Core Ex Vivo Programs:

Azer-Cel (azercabtagene zapreleucel allogeneic CAR T treatment for cancer)

Imugene Limited, Precision’s clinical stage partner developing azer-cel for oncology indications, announced on September 17th, additional efficacy data from its Phase 1b clinical trial evaluating azer-cel in patients with relapsed/refractory diffuse large B-cell lymphoma. The updated data showcased an overall response rate of 81% in patients treated with azer-cel and IL-2 with seven complete responses and six partial responses including several patients remaining in durable remission beyond one year.

On October 28th, Imugene announced the first efficacy results from the CAR T-naïve indication cohort of its ongoing Phase 1b trial of azer-cel. Of the six evaluable CAR T-naïve patients, five (83%) achieved an overall response including three (50%) complete responses. The result of the sixth patient’s follow-up scan is pending. A total of ten patients have been treated in this CAR T-naïve cohort thus far, with additional results to come upon patient follow-up. These initial results encompass several rare lymphoma subtypes, notably Waldenström Macroglobulinemia (WM), Marginal Zone Lymphoma (MZL) and Primary Central Nervous System Lymphoma (PCNSL).

Imugene is actively enrolling patients in the Phase 1b azer-cel trial at ten U.S. sites and five sites in Australia. Imugene has scheduled a Type C meeting with the U.S. Food and Drug Administration (FDA) to discuss potential pivotal study design options for azer-cel. The decision to proceed to a meeting with the FDA to discuss a pivotal trial reflects the positive, durable clinical data that has been generated to date and adds to the growing clinical data set supporting the ARCUS platform. On October 31, 2025, Precision received an $8 million milestone payment in cash and stock from Imugene.

Corporate Updates:

Mark Sulkowski, M.D. Appointed Head Clinical Development Advisor

In August, Mark Sulkowski, Professor of Medicine at the Johns Hopkins University School of Medicine and renowned expert in hepatic and infectious diseases has expanded his advisory role with Precision. In the newly created role, Head Clinical Development Advisor, Dr. Sulkowski will work closely with Precision’s leadership and cross-functional teams to support clinical strategy across the development lifecycle for the Company’s on-going PBGENE-HBV Phase 1 clinical trial as well as initiation of later stage trials. His advisory role will focus on optimizing clinical trials, including translational integration, and aligning scientific rationale with regulatory objectives.

Quarter Ended September 30, 2025 Financial Results

In July 2025, the Company implemented operating efficiencies, including employment related and other expense reductions, to reduce annual operating expenses and extend its expected cash runway. In the third quarter of 2025, the Company realized reductions in early research and general & administrative expenses which reduced the Company’s operating expenses compared to both the second quarter of 2025 and third quarter of 2024.

Cash, Cash Equivalents, and Restricted Cash: As of September 30, 2025, Precision had approximately $71.2 million in cash, cash equivalents and restricted cash. Based on its expected cash runway, Precision believes it is sufficiently capitalized to reach important milestones for PBGENE-HBV and PBGENE-DMD. The Company expects existing cash and cash equivalents, potential near-term cash from CAR T transactions, along with expected operating efficiencies, operational receipts, and availability of Precision’s at-the-market (ATM) facility to extend Precision’s cash runway into the second half of 2027.

Revenues: Total revenues for the quarter ended September 30, 2025, were less than $0.1 million as compared to $0.6 million for the quarter ended September 30, 2024. The decrease was primarily the result of less billable effort under the Novartis Agreement.

Research and Development Expenses: Research and development expenses were $13.4 million for the quarter ended September 30, 2025, as compared to $13.1 million for the quarter ended September 30, 2024. The increase was primarily the result of an increase in the PBGENE-DMD program partially offset by decreases in the PBGENE-HBV program as it transitioned to the clinic at the end of 2024 and the PBGENE-3243 program which has been paused.

General and Administrative Expenses: General and administrative expenses were $7.3 million for the quarter ended September 30, 2025, as compared to $8.8 million for the quarter ended September 30, 2024. The decrease was primarily the result of employee-related costs and other general and administrative expenses.

Net Loss: Net loss was $21.8 million, or ($1.84) per share (basic and diluted), for the quarter ended September 30, 2025. Net loss was $16.4 million or $(2.25) per share (basic and diluted) for the quarter ended September 30, 2024.

About PBGENE-HBV, A Viral Elimination Program

PBGENE-HBV is Precision’s wholly owned in vivo gene editing program under investigation in a global first-in-human clinical trial, which is designed to be a potentially curative treatment for chronic Hepatitis B infection. PBGENE-HBV is the first and only potentially curative gene editing program to enter the clinic that is specifically designed to eliminate the root cause of chronic Hepatitis B, cccDNA, while inactivating integrated HBV DNA. The ELIMINATE-B trial is investigating PBGENE-HBV at multiple ascending dose levels with three dose administrations per dose level in patients with chronic Hepatitis B. PBGENE-HBV has been granted Breakthrough Therapy designation by the FDA.

About PBGENE-DMD, A Muscle-Targeted Excision Program

PBGENE-DMD is Precision’s development program for the treatment of DMD. DMD is a genetic disease caused by mutations in the dystrophin gene that prevent production of the dystrophin protein and affects approximately 15,000 patients in the U.S. alone. There are currently no approved therapies that can drive durable and significant functional improvements over time. PBGENE-DMD is designed to improve function for more than 60% of patients afflicted with DMD by employing two complementary ARCUS nucleases delivered in a single AAV to excise exons 45-55 of the dystrophin gene. The aim of this approach is to restore a near-full length functional dystrophin protein within the body that more closely resembles normal dystrophin as opposed to synthetic, truncated dystrophin approaches with minimal functional benefit. PBGENE-DMD has received both Rare Pediatric Disease and Orphan Drug designations from the U.S. FDA.

(Press release, Precision Biosciences, NOV 3, 2025, View Source [SID1234659275])

On November 3, 2025 Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL gene silencing technology to eliminate cancer. Phio reported the pathologic results for three patients with cutaneous squamous cell carcinoma (cSCC) who completed treatment in the fifth and final dose cohort of Phio’s on-going Phase 1b dose escalation trial: 100% tumor clearance in one of three patients, > 90% clearance in the second patient, and > 50% clearance in the third patient.

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To date, a total of 18 patients with cutaneous carcinomas have completed treatment across five dose escalating cohorts in the Phase 1b trial. The cumulative pathologic response in 16 patients with cSCC include six with a complete response (100% clearance), two with a near complete response (> 90% clearance) and two with a partial response (> 50% clearance). A single patient with metastatic Merkel cell carcinoma had a partial response (> 50% clearance). Six patients with cSCC and one patient with metastatic melanoma had a pathologic non-response (< 50% clearance). No patients in the study have exhibited clinical progression of disease. Phio may continue to screen and treat additional patients as part of the fifth cohort.

The trial is designed to evaluate the safety and tolerability of neoadjuvant use of intratumoral PH-762 in Stages 1, 2 and 4 cutaneous squamous cell carcinoma (cSCC), Stage 4 melanoma, and Stage 4 Merkel cell carcinoma (NCT# 06014086). Per the trial’s protocol, patients receive four injections of PH-762 at weekly intervals and pathologic response is assessed approximately 5 weeks after the initial injection of PH-762.

"The encouraging outcomes of intratumoral PH-762 in patients who have received treatment thus far is a significant step in clinical development and highlights the promise of a viable non-surgical alternative treatment for cutaneous carcinomas," said Robert Bitterman, CEO and Chairman of Phio Pharmaceuticals.

In addition, the Safety Monitoring Committee (SMC) completed its pre-specified review of safety results for the first three patients in the fifth cohort and confirmed that there were no dose-limiting toxicities or clinically relevant treatment-emergent adverse effects at this maximum dose concentration. Further, there have been no dose-limiting toxicities or clinically relevant treatment-emergent adverse effects in any of the patients who have completed treatment with intratumoral PH-762 in this trial.

"We are pleased with the continuing safety profile of PH-762 throughout dose escalation to approximately a 20-fold increase versus that received in the first cohort," said Mary Spellman, MD, Phio’s acting Chief Medical Officer. "PH-762 has been well tolerated in this trial, without relevant immune-related adverse events or other toxicities."

(Press release, Phio Pharmaceuticals, NOV 3, 2025, View Source [SID1234659274])

On November 3, 2025 Orum Therapeutics ("Orum" or the "Company") (KRX: 475830), a public biotechnology company pioneering the field of degrader-antibody conjugates (DACs), reported that preclinical data for ORM-1153, a CD123-targeting DAC with a GSPT1-degrading payload, have been selected for presentation at the upcoming 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, taking place December 6 to 9, 2025, in Orlando, Florida.

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The presentation will feature data from preclinical studies of ORM-1153, a novel CD123-targeting DAC designed to deliver Orum’s proprietary GSPT1-degrading payload, SMol006, selectively into cancer cells to achieve targeted protein degradation and antitumor activity in acute myeloid leukemia (AML). The results support further investigation of ORM-1153 as a potential therapeutic option for AML and other CD123-positive hematologic malignancies, including those with TP53-mutant status.

Details of the ASH (Free ASH Whitepaper) 2025 Presentation

Title: ORM-1153: A CD123-Targeting Degrader Antibody Conjugate with GSPT1-Degrading Payload Exhibits Potent Preclinical Antitumor Activity in Acute Myeloid Leukemia

Session: 604. Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms: Poster III

Session Type: Poster Presentation

Session Date and Time: December 8, 2025, from 6 pm to 8 pm ET

Location: Orange County Convention Center (OCCC), West Halls B3-B4

Abstract Number: 5051

About Orum’s TPD² Approach

Orum’s unique Dual-Precision Targeted Protein Degradation (TPD²) approach builds novel targeted protein degraders combined with the precise cell delivery mechanisms of antibodies to generate innovative, first-in-class, cell-selective TPDs for the treatment of cancer and other serious diseases. Orum has developed new targeted protein degrader payloads to specifically degrade an intracellular target protein within cancer cells via the E3 ubiquitin ligase pathway. Conjugated to antibodies, the payloads are designed to be delivered specifically to target cells and precisely degrade the intracellular target protein of interest.

(Press release, Orum Therapeutics, NOV 3, 2025, View Source [SID1234659273])

On November 3, 2025 Orna Therapeutics, a biotechnology company dedicated to engineering immune cells in vivo to treat autoimmune and oncology diseases, reported upcoming presentations at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting being held December 6-9, 2025, in Orlando, Florida. The oral and poster presentations will highlight data supporting Orna’s leading in vivo CAR programs to target and treat a broad range of B-cell driven autoimmune diseases and its anti-BCMA platform to selectively deplete plasma cells.

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"We are excited to share new data at ASH (Free ASH Whitepaper) from our NHP studies for our CD19 and BCMA panCAR programs," said Joseph Bolen, Ph.D., Chief Executive Officer of Orna Therapeutics. "Data to be presented continues to demonstrate the best-in-class nature of our in vivo CAR platform in NHP for both our anti-CD19 and our anti-BCMA programs. As we look ahead, we have completed our pre-clinical package for anti-CD19 and will be submitting our Clinical Trial Application this Quarter."

Oral Presentation details:

Title: In Vivo pan CAR Therapy Utilizing Circular RNA for Treatment of Autoimmune Diseases
Speaker: Isin Dalkilic-Liddle, Ph.D., VP Discovery Sciences,, Orna Therapeutics
Date/Time: Saturday, December 6, 2025, 9:45 AM – 10:00 AM ET
Session Name: CAR-T Cell Therapies: Basic and Translational: In vivo CAR-T cell platforms and resistance mechanisms
Location: OCCC – Sunburst Room (W340)

Poster Presentation details:

Title: In Vivo pan CAR Therapy Utilizing Circular RNA for Treatment of Multiple Myeloma
Speaker: Rebecca Silver, Ph.D., Pr. Scientist, Orna Therapeutics
Date/Time: Sunday, December 7, 2025, 6:00 PM – 8:00 PM ET
Session Name: CAR-T Cell Therapies: Basic and Translational: Poster II
Location: OCCC – West Halls B3-B4

By leveraging its leading oRNA technology and best-in-class LNP delivery, Orna’s in vivo oRNA panCAR therapies hold the potential to benefit patients across multiple B cell driven autoimmune diseases. New data to be presented at ASH (Free ASH Whitepaper) will highlight the ability of Orna’s oRNA panCAR platform to generate deep and sustained B cell depletion in non-human primates across multiple doses in multiple therapeutic areas.

(Press release, Orna Therapeutics, NOV 3, 2025, View Source [SID1234659272])