On November 9, 2026 Faeth Therapeutics (Nasdaq: FTH), a clinical-stage oncology company developing multi-node therapies for cancer patients, including its lead program PIKTOR, reported topline clinical data from its Phase 2 trial (FTH-PIK-201; NCT06463028; GOG-3111) of PIKTOR, an investigational all-oral combination of serabelisib and sapanisertib, given with paclitaxel to patients with advanced endometrioid endometrial cancer and a PI3K/AKT/mTOR (PAM) pathway mutation who had received at least one prior line of therapy. The trial is being conducted in collaboration with The GOG Foundation, Inc. (GOG-F).

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The Phase 2 trial is ongoing, and the topline data include 42 patients with endometrioid endometrial cancer who had a median of 2 prior lines of therapy (range 1-4 lines). As of the October 30, 2026 efficacy data cut, confirmed objective responses were observed in 12 of the 36 efficacy-evaluable patients, for a confirmed objective response rate (ORR) of 33%. One additional patient had a partial response that could not be confirmed because the patient discontinued the study before a confirmatory scan, for an unconfirmed ORR of 36% (13 of 36). Among patients with a PIK3CA mutation, the confirmed ORR was 44% (7 of 16). In the 42 treated patients, the preliminary Kaplan-Meier estimated median progression-free survival (PFS) was 7.4 months (95% CI 5.3-NR), and the 6-month PFS rate was 62% (95% CI 43%-75%); 16 patients remained on treatment at the data cut.

"We believe these data support the multi-nodal PAM targeting hypothesis, whereby more complete inhibition of the pathway may drive durable responses and extend progression-free survival without the safety limitations of single-node inhibitors," said Anand Parikh, Co-Founder and Chief Executive Officer of Faeth. "Endometrial cancer has among the highest rates of PI3K pathway alterations of any cancer, yet no drug that targets the pathway is approved to treat it.

"In PIK-201, PIKTOR delivered a preliminary estimated median PFS of 7.4 months, which we believe compares favorably to the 3-4 months typical for salvage chemotherapy alone, or the 6-7 months observed with newer treatments including TOPO1-based ADCs." Mr. Parikh continued, "In our view, these preliminary data set PIKTOR apart. On the safety side, hyperglycemia and stomatitis were mostly low grade in a population in which nearly half of patients had diabetes or prediabetes and prophylactic steroid mouthwash was not required. We now plan to advance toward a Phase 3 trial, subject to regulatory alignment, with the goal of getting PIKTOR into the hands of patients as expeditiously as possible."

"We need more treatment options for patients whose advanced endometrial cancer has progressed after platinum chemotherapy and immunotherapy," said David Starks, MD, MPH, a PIK-201 and GOG Foundation principal investigator and Gynecologic Oncologist at Avera Cancer Institute, Sioux Falls, South Dakota. "I believe the response and progression-free survival data reported for PIKTOR with paclitaxel give physicians a reason to follow it closely. I am excited by the potential that this treatment could have for my patients."

Phase 2 FTH-PIK-201 Topline Clinical Data Highlights

Baseline characteristics

The open-label, single-arm Phase 2 trial (NCT06463028, GOG-3111) is evaluating patients with PIKTOR plus paclitaxel.
48% of patients had diabetes or pre-diabetes at baseline.
76% of patients had distant metastases, including liver and lung lesions.
Patients had a median of 2 prior lines of therapy (range 1 to 4), with 3 or more prior lines in 15 patients (36%).
All patients had been previously treated with taxane-based chemotherapy (100%), and prior immunotherapy was reported in 41 patients (98%).
Of the 42 treated patients, 6 were not evaluable for efficacy, having discontinued prior to the first post-baseline scan due to early disease progression (n=3) or non-treatment-related reasons (n=3).
Efficacy

As of the October 30, 2026 efficacy data cut:

The confirmed ORR was 33% (12 of 36 efficacy-evaluable patients). One additional patient had a partial response that could not be confirmed because the patient discontinued the study before a confirmatory scan, for an unconfirmed ORR of 36% (13 of 36).
Among patients with a PIK3CA mutation, the confirmed ORR was 44% (7 of 16).
At the data cut, 9 of the 12 confirmed responders and 7 patients with a best response of stable disease remained on treatment. Several responses deepened over the course of therapy, including one patient who converted from stable disease to partial response after 20 months of treatment.
The disease control rate (DCR) was 83% (30 of 36), defined as the percentage of patients with a best overall response of complete response, partial response or stable disease.
In all 42 treated patients, the preliminary Kaplan-Meier estimated median PFS was 7.4 months (95% CI: 5.3 to NR), and the preliminary 6-month PFS rate was 62% (95% CI: 43% to 75%).
Safety

As of the October 23, 2026 safety data cut:

Two patients (5%) discontinued treatment due to a treatment-related adverse event (TRAE; headache, dizziness). There were no treatment-related deaths.
64% of patients had a grade 3 or higher TRAE. Neutropenia, a grouped term including neutropenia and decreased neutrophil count, occurred in 36% of patients overall and was the most frequent grade 3 or higher TRAE (26%).
Hyperglycemia TRAEs occurred in 5 of 42 patients (12%), and 1 patient (2%) had a grade 3 event. 48% of patients had diabetes or pre-diabetes at baseline.
Stomatitis TRAEs occurred in 21% of patients, and 1 patient (2%) had a grade 3 event. Patients did not receive steroid mouthwash prophylaxis.
Webcast details

Faeth will host a webcast today, November 9, 2026, at 8:00 a.m. ET to discuss the data. David Starks, MD, MPH, Gynecologic Oncologist at Avera Cancer Institute, Sioux Falls, South Dakota, will join management. To access the live webcast, click here. A replay will be available in the Events and Presentations (Events and Presentations — Faeth Therapeutics, Inc) section of Faeth’s corporate website.

(Press release, Faeth Therapeutics, NOV 9, 2026, View Source [SID1234674503])

On November 9, 2026 Editas Medicine, Inc. (Nasdaq: EDIT), a pioneering gene editing company focused on developing transformative medicines for serious diseases, reported financial results for the third quarter 2026 and provided business updates.

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"We are incredibly excited by the progress we made in the third quarter as we advanced EDIT-401, our potentially best-in-class in vivo gene editing medicine for hyperlipidemia, towards the clinic," said Gilmore O’Neill, M.B., M.M.Sc., President and Chief Executive Officer of Editas Medicine. "The recent regulatory and ethics approval to initiate the Strive study in Australia and new preclinical durability data presented at AHA represent important milestones for EDIT-401, and, more importantly, for patients living with hyperlipidemia. Backed by this momentum and our strong cash position, we look forward to executing on the Strive study and generating additional data in 2027."

EDIT-401

Editas received Human Research Ethics Committee (HREC) approval and completed the Clinical Trial Notification (CTN) process with Australia’s Therapeutic Goods Administration (TGA) to initiate the Phase 1/2 Strive study of EDIT-401 in patients with Heterozygous Familial Hypercholesterolemia (HeFH) in Australia.
The Company remains on track to begin patient dosing this year and report initial safety and tolerability data in the first quarter of 2027.
The Company expects to complete enrollment in Part 1 of the Strive study, with topline safety and efficacy results from Part 1 available in the second half of 2027.
Editas shared new EDIT-401 preclinical data in an oral presentation at the American Heart Association (AHA) Scientific Sessions 2026 in November demonstrating durable LDL-C lowering with EDIT-401 and further supporting its potential as a transformative, one-time treatment for people living with hyperlipidemia. Key data presented included:
LDL-C reduction of ≥90 percent with EDIT-401 was maintained over 10 months in an ongoing study in non-human primates (NHPs).
EDIT-401 achieved ~90 percent mean Lp(a) and ApoB reductions, which was maintained over three months in an ongoing study in NHPs.
Consistent safety profile with targeted delivery to the liver, transient elevations in LFTs, no histopathologic findings, and no evidence of genotoxicity in relevant primary human cells.

Corporate & Business Development Updates

In October, Editas presented two posters at the 33rd Annual European Society of Gene and Cell Therapy (ESGCT) Congress with preclinical data demonstrating robust in vivo delivery of mRNA to targeted T-cells with the Company’s novel, scalable platform for targeted lipid nanoparticle (tLNP) extrahepatic delivery, as well as data highlighting how platform-driven LNP process development can accelerate development timelines, mitigate scale-up risk, and effectively bridge discovery-stage innovation with the clinic, enabling the next generation of in vivo genetic medicines.

In September, Editas announced the appointment of Dan Ory, M.D., as Chief Medical Officer. With more than 25 years of experience spanning biotechnology leadership, cardiovascular medicine, and the development of genetic medicines, Dr. Ory will oversee the Company’s clinical development strategy and operations as Editas advances EDIT-401 into the clinic, while supporting the progression of the company’s broader pipeline.

As part of the Company’s collaboration agreement with Bristol Myers Squibb, a second IND/CTA was accepted for an alpha-beta T cell medicine, triggering a milestone payment to Editas. BMS will advance this second collaboration product, BMS-986527, a CD70 healthy-donor allogeneic CAR-T therapy, in a Phase 1 clinical study evaluating its safety and tolerability in participants with clear cell renal cell carcinoma, the most common form of kidney cancer. Editas developed the Cas12a gene editing technology used to engineer the CAR-T cells.

Upcoming Events

Editas Medicine plans to participate in the following investor event:

9th Annual Evercore Healthcare Conference
Format: Fireside Chat
Date: November 30, 2026
Time: 3:25 p.m. ET
Location: Coral Gables, FL

To access a live webcast of the Fireside Chat, please visit the "Investors" section of the Company’s website at www.editasmedicine.com. An archived replay will be available for approximately 30 days following the event.

Third Quarter 2026 Financial Results

Cash, cash equivalents, and marketable securities as of September 30, 2026, were $190.2 million compared to $146.6 million as of December 31, 2025. The Company expects that its existing cash, cash equivalents, and marketable securities will enable the Company to fund its operating expenses and capital expenditure requirements into the second half of 2028.
For the three months ended September 30, 2026, net loss attributable to common stockholders was $23.4 million, or $0.15 per share, compared to net loss of $25.1 million, or $0.28 per share, for the same period in 2025.
Collaboration and other research and development revenues increased to $10.4 million for the three months ended September 30, 2026, compared to $7.5 million for the same period in 2025. The increase was primarily attributable to revenue recognized in connection with clinical development milestones achieved by a strategic partner.
Research and development expenses increased by $1.4 million to $21.2 million for the three months ended September 30, 2026, compared to $19.8 million for the same period in 2025. The increase was primarily related to higher sublicense and license fees as well as increased costs associated with the continued development of EDIT-401. These increases were partially offset by lower employee-related costs and external research and development costs.
General and administrative expenses increased by $1.2 million to $13.5 million for the three months ended September 30, 2026, compared to $12.3 million for the same period in 2025. The increase was primarily attributable to higher intellectual property and patent-related fees due to increased legal activity related to intellectual property defense.

About EDIT-401
EDIT-401 is an experimental, potentially best-in-class in vivo gene editing medicine, based on Editas’ differentiated upregulation approach. EDIT-401 is designed to treat hyperlipidemia by directly editing the LDLR gene to increase LDLR protein expression and reduce LDL-C levels. This targeted approach has demonstrated a favorable preclinical profile in both efficacy data and tolerability and supports the potential of EDIT-401 to deliver meaningful clinical outcomes for patients underserved by current lipid-lowering therapies.

About Heterozygous Familial Hypercholesterolemia (HeFH)
Heterozygous Familial Hypercholesterolemia (HeFH) is an inherited genetic disorder that leads to significantly elevated LDL‑cholesterol levels from an early age. Individuals with HeFH are at high risk of heart disease, heart attack, or stroke if the condition is not identified and treated early. An estimated 1.2 million people in the United States are living with HeFH, though many remain undiagnosed. Elevated LDL-C, also known as hyperlipidemia, is a highly prevalent disease affecting over 70 million patients in the United States alone. Substantial unmet need exists across multiple at-risk segments of patients with hyperlipidemia, including the HeFH population.

(Press release, Editas Medicine, NOV 9, 2026, View Source [SID1234674502])

On November 9, 2026 GT Biopharma, Inc. (the "Company") (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary TriKE natural killer (NK) cell engager platform, reported preclinical data presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2026 Annual Meeting taking place from November 4-8, 2026 in Phoenix, AZ.

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"We continue to make progress enrolling patients into our ongoing Phase 1a/1b dose escalation basket trial with GTB-5550 in multiple tumor types", said Michael Breen, Executive Chairman and Chief Executive Officer of GT Biopharma. "Given the recent advances in this field with KRAS inhibitors becoming a new standard of care and these extremely compelling preclinical results, we are considering all options to conduct a future Phase 1b study combining GTB-5550 with a KRASi in pancreatic cancer patients".

Despite significant recent advances in the field, monotherapy with RAS inhibitors can trigger early resistance via bypass pathways, and the industry is moving more towards the opportunity for multi-drug combinations to provide deeper, more durable responses than single agent KRAS inhibition. The new data demonstrate that GTB-5550 has the potential to improve the effectiveness of KRAS inhibition by making pancreatic cancer cells more susceptible to NK cell cytotoxicity. In orthotopic PDAC xenograft models, the combination of GTB-5550 plus KRASi demonstrated superior tumor control, including complete tumor clearance in several animals, while significantly reducing local invasion and preventing metastasis. When compared to KRASi treatment alone, KRASi + GTB-5550 treatment was associated with a two-fold increase in tumor-infiltration, as well as increases in persistence and CXCR3 expression of adoptively transferred NK cells. This enhanced treatment effect also correlated with a corresponding increase in apoptosis markers on tumor cells.

Oral Presentation Details

Title: Inhibition of the KRAS oncoprotein sensitizes pancreatic cancer to NK cell immunotherapy
Abstract No.: 655
Presenter: Paarth Dodhiawala, University of Minnesota Medical School1
Date: Friday, November 6, 2026
Time: 3:05-3:20 PM MT
Session 106a: Combination Therapies Involving Cell Therapy, 1:45-3:25 PM MST
Session Description: While cell therapy has transformed the treatment of certain hematologic malignancies, its impact in solid tumors remains limited by antigen heterogeneity, immunosuppressive microenvironments, and nutrient deprivation. As efforts to engineer more effective immune cells continue, there is growing interest in combining cell therapies with complementary approaches to enhance their function and engage endogenous immunity. This session will highlight diverse strategies to extend the clinical impact of cell therapies through rational combination approaches.

(Press release, GT Biopharma, NOV 9, 2026, View Source [SID1234674501])

On November 9, 2026 Immunome, Inc. (Nasdaq: IMNM), a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class cancer therapies, reported financial results for the quarter ended September 30, 2026, and provided a business update.

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"We made significant progress across our oncology pipeline in recent months," said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Immunome. "We continue to advance varegacestat toward approval and launch, with an FDA PDUFA date of April 28, 2027, and recent EMA validation of our MAA. Beyond varegacestat, we now have three programs in the clinic, with IM-1340 expected to become the fourth by year-end. We are progressing the Phase 1 study of IM-1021, our ROR1-targeted ADC, and look forward to presenting updated Phase 1 data at ASH (Free ASH Whitepaper) in December."

Pipeline Highlights

Varegacestat:

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The U.S. FDA accepted the varegacestat NDA in July 2026 and assigned a PDUFA target action date of April 28, 2027.
•
In October 2026, the EMA validated Immunome’s MAA for varegacestat for the treatment of adults with desmoid tumors.
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Additional Phase 3 RINGSIDE data, including patient-reported outcomes, were presented across three posters and a rapid oral session at the 2026 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress.

IM-1021: The Phase 1 clinical trial of IM-1021 is ongoing, and Immunome expects to present an updated dataset at the 2026 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting on December 14, 2026. Previously reported results as of the June 26, 2026 abstract data cutoff included:

•
Among 11 response-evaluable patients with diffuse large B-cell lymphoma (DLBCL), the objective response rate was 64% (7/11), including three complete responses. Across all 19 response-evaluable patients with B-cell non-Hodgkin lymphoma (B-NHL), the objective response rate was 53% (10/19), including five complete responses.
•
Among 25 treated B-NHL patients, treatment-emergent adverse events (TEAEs) were reported in 92%. Grade 3 or higher TEAEs occurred in 52% of B-NHL patients, of which the most common was neutropenia (44%).

IM-1617: In June 2026, the first patient was dosed in the Phase 1, first-in-human trial evaluating IM-1617 in patients with advanced solid tumors. IM-1617 is an ADC directed at an undisclosed solid tumor target and incorporates HC74, Immunome’s proprietary TOP1 inhibitor payload. The study is expected to include participants with advanced solid tumors, including colorectal cancer, non-small cell lung cancer and breast cancer.

IM-1340: Immunome received IND clearance for IM-1340 in September 2026. The company plans to initiate a Phase 1 trial by year-end. IM-1340 is a potential first-in-class ADC directed at an undisclosed solid tumor target and incorporates HC74, Immunome’s proprietary TOP1 inhibitor payload. The trial is expected to include patients with advanced solid tumors, including colorectal cancer, non-small cell lung cancer, small cell lung cancer and neuroendocrine neoplasms.

IM-3050: In July 2026, the first patient was dosed in the Phase 1, first-in-human trial evaluating IM-3050 in patients with FAP-expressing advanced solid tumors. The trial is designed to evaluate safety, tolerability, dosimetry, pharmacokinetics and preliminary anti-tumor activity of the investigational FAP-targeted radioligand therapy.

Preclinical ADC Pipeline: Immunome expects to submit an IND for IM-1335 in late 2026. The program is directed at an undisclosed solid tumor target and incorporates HC74. Additional undisclosed ADCs are in discovery and lead optimization to support INDs in 2027 and beyond.

Third Quarter 2026 Financial Results

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As of September 30, 2026, cash, cash equivalents and marketable securities totaled $461.6 million. Immunome expects its current cash position to fund operations into 2028.
•
Research and development expenses for the quarter ended September 30, 2026, were $69.5 million, including stock-based compensation expense of $6.6 million.
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General and administrative expenses for the quarter ended September 30, 2026, were $20.9 million, including stock-based compensation expense of $6.2 million.
•
Immunome reported a net loss of $85.8 million for the quarter ended September 30, 2026.

(Press release, Immunome, NOV 9, 2026, View Source [SID1234674496])

On November 9, 2026 Avenzo Therapeutics, Inc. ("Avenzo"), a clinical-stage biotechnology company developing next-generation oncology therapies, reported that Athena Countouriotis, M.D., Chair, President and CEO, will present and host investor meetings at the 2026 Jefferies Global Healthcare Conference in London, taking place November 16-19, 2026.

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2026 Jefferies Global Healthcare Conference in London
Event: Corporate Presentation
Date: Wednesday, November 18, 2026
Presentation Time: 4:00 to 4:25 p.m. GMT / 11:00 to 11:25 a.m. EST

A live webcast of the presentation will be accessible on the company’s website, www.avenzotx.com under the Events & Presentations section and an archived recording will be available on the website for 90 days following the presentation.

(Press release, Avenzo Therapeutics, NOV 9, 2026, View Source [SID1234674495])