On November 6, 2026 CG Oncology, Inc. (NASDAQ: CGON) reported financial results for the third quarter ended September 30, 2026, and provided business updates.

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"We are entering an eventful period for CG Oncology as we look forward to sharing PIVOT-006 topline data this month. As a reminder, PIVOT-006 is the first randomized registrational trial in intermediate-risk and high-grade Ta NMIBC. Additionally, we expect to have 12-month data from both CORE-008 Cohort CX and BOND-003 Cohort P in December, which further strengthens the growing body of evidence for cretostimogene across the NMIBC landscape and supports our goal to address the broadest number of patients. We remain confident in cretostimogene’s potential to become a backbone therapy for patients and to create long-term value for shareholders," stated Arthur Kuan, Chairman, President & Chief Executive Officer at CG Oncology.

Corporate Highlights

Strengthened Executive Leadership Team with the addition of life-science executive Isabel Kalofonos as Chief Commercial Officer
In October, the Company appointed Isabel Kalofonos as Chief Commercial Officer. Ms. Kalofonos brings more than 20 years of experience driving successful launches including PALSONIFYTM (paltusotine) and ELAHERE (mirvetuximab soravtansine) through strong commercial execution, helping bring innovative therapies to patients at scale across the biotechnology and pharmaceutical industries.
Anticipated 2026 Milestones

PIVOT-006 (intermediate-risk and high-grade Ta ≤ 3cm NMIBC): Phase 3 topline data November 2026
CORE-008 Cohort CX (BCG-exposed HR and BCG-unresponsive NMIBC) 12-month data December 2026
BOND-003 Cohort P (BCG-unresponsive papillary only NMIBC) 12-month data December 2026
Completion of BLA submission in initial indication of BCG-unresponsive NMIBC with CIS with or without papillary disease Q4 2026

Third Quarter Financial Highlights

Cash Position: Cash, cash equivalents and marketable securities as of September 30, 2026 were $984.5 million, compared with $1.0 billion as of June 30, 2026.  The Company anticipates its existing cash, cash equivalents and marketable securities as of this date will be sufficient to fund operations through 2029.
Research and Development (R&D) Expenses: R&D expenses were $39.2 million for the third quarter of 2026, as compared to $27.9 million for the prior year period. The increase was primarily due to an increase in clinical trial expenses, including CMC costs, and an increase in compensation costs due to increased headcount.
General and Administrative (G&A) Expenses: G&A expenses were $23.0 million for the third quarter of 2026, as compared to $23.3 million for the prior year period. The decrease was primarily due to a decrease in professional and consultant fees, partially offset by an increase in personnel-related expenses, including compensation costs from increased headcount, and an increase in other general G&A expenses.
Net Loss: Net loss was $56.9 million, or $(0.64) per share, for the third quarter of 2026, as compared to a net loss of $43.8 million, or $(0.57) per share, for the prior year period.

About Cretostimogene Grenadenorepvec

Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy that has been studied in a clinical development program, which includes more than 700 patients with Non-Muscle Invasive Bladder Cancer (NMIBC). This program includes two Phase 3 clinical trials: BOND-003 for BCG-unresponsive NMIBC and PIVOT-006 for intermediate-risk and high-grade Ta ≤ 3cm NMIBC. Cretostimogene has received FDA Fast Track and Breakthrough Therapy designations for BCG-unresponsive NMIBC. CG Oncology also has a multi-cohort trial, CORE-008, evaluating the safety and efficacy of cretostimogene in BCG-exposed HR and BCG-unresponsive NMIBC. Additionally, we have initiated an Expanded Access Program for cretostimogene in North America for patients who are unresponsive to BCG and meet certain program eligibility requirements. Cretostimogene is an investigational candidate, and its safety and efficacy have not been established by the FDA or any other health authority.

(Press release, CG Oncology, NOV 6, 2026, View Source [SID1234674426])

On November 6, 2026 Immuneering Corporation (Nasdaq: IMRX), a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive, reported compelling preclinical data demonstrating that atebimetinib, the Company’s novel Deep Cyclic Inhibitor of MEK, enhanced the activity of PD-1 checkpoint blockade in RAS-mutant colorectal and lung cancer models, including a 50% durable complete regression rate in a colorectal model and a 1.8-fold median survival improvement with a triple combination in a lung model. The data are being presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 41st Annual Meeting, taking place November 4-8, 2026, in Phoenix, Arizona.

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"Curing 50% of mice in one tumor model and nearly doubling median overall survival in another are both incredibly exciting. These data add to the body of preclinical evidence that combining a pulsatile inhibitor of MEK with immunotherapy may lead to enhanced activity," said Ben Zeskind, Ph.D., Co-Founder and Chief Executive Officer of Immuneering. "The ultimate test of this hypothesis will be to show it in patients, and it starts very soon: we expect to dose the first patient by the end of the year in our Phase 2 clinical trial of atebimetinib in combination with anti-PD-1 and chemotherapy in first-line RAS-mutant NSCLC patients."

In the CT-26 syngeneic mouse model of colorectal cancer, both the 75 mg/kg and 125 mg/kg atebimetinib plus anti-PD-1 groups achieved complete tumor regression in 6 of 12 mice (50%) per group, with no regrowth even after treatment discontinuation. Vehicle-treated animals had median survival of 21 days, while anti-PD-1 alone resulted in median survival of 29 days and atebimetinib monotherapy extended median survival dose-dependently from 28 to 41.5 days. In contrast, median survival was not reached in the atebimetinib plus anti-PD-1 combination groups, which outperformed the single-agent arms (P<0.0001 versus vehicle for nearly all combinations).

In the LL2 syngeneic lung cancer model, a PD-1-cold model unresponsive to anti-PD-1 monotherapy, atebimetinib demonstrated enhanced antitumor activity in combination with anti-PD-1 and platinum-doublet chemotherapy. At 125 mg/kg BID, atebimetinib plus anti-PD-1, carboplatin and pemetrexed extended median survival to 25 days, compared with 14 days for anti-PD-1 plus chemotherapy alone, representing a 1.8-fold improvement. All 12 mice receiving the triple combination were alive at Day 18, compared with none of the 12 mice receiving anti-PD-1 plus chemotherapy alone. These data support further clinical investigation of this combination in first-line RAS-mutant non-small cell lung cancer (NSCLC).

Presentation Details:
Title: "Cyclic disruption of the mitogen-activated protein kinase (MAPK) pathway by the pulsatile MEK inhibitor, Atebimetinib, enhances PD-1 checkpoint blockade in RAS mutant tumors."
Abstract: #377
Presenting Author: Amy E. Axel, Immuneering Corporation
Presentation: Friday, November 6, 2026

Following presentation, the poster will be available on the publications section of Immuneering’s website at View Source

(Press release, Immuneering, NOV 6, 2026, https://www.globenewswire.com/news-release/2026/11/06/3397545/0/en/atebimetinib-combinations-with-anti-pd1-cured-50-of-mice-in-a-ras-mutant-colorectal-cancer-model-and-nearly-doubled-survival-in-a-ras-mutant-lung-cancer-model-new-data-presented-at.html [SID1234674425])

On November 6, 2026 Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases, reported it will present data on the novel mechanism of action for CTX-10726 at the 41st Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. CTX-10726 is currently in a Phase 1 dose-escalation study in patients in the post-checkpoint setting with multiple types of advanced solid tumors.

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Data highlights from the presentation include:

Novel PD-1 Cleavage Mechanism. In addition to the expected dual blockade of VEGF-A and PD-1, preclinical studies also revealed a novel mechanism of action for CTX-10726. Specifically, the multimerization of CTX-10726 facilitates the cleavage and removal of PD-1 from the surface of T cells, converting PD-1 positive T cells into PD-1 negative T cells and extending the mechanism beyond simply checkpoint blockade and angiogenesis inhibition.
VEGF-A Enhanced Potency. Adding VEGF-A increased the potency of CTX-10726 approximately ten-fold in a human immune-cell assay measuring interferon-gamma production, reducing the EC50 from 2.0 to 0.2 nM. In vitro studies showed PD-1 receptor cleavage by CTX-10726 in the presence of VEGF-A compared to PD-1 receptor internalization in the absence of VEGF-A. Neither pembrolizumab nor bevacizumab alone demonstrate comparable PD-1 cleavage. Two in vivo models further demonstrated the VEGF-A-dependent nature of PD-1 receptor cleavage by CTX-10726.
Combined Activity with CTX-471. A mouse surrogate of CTX-10726 combined with CTX-471 (CD137 agonist antibody) further enhanced anti-tumor activity in mouse models, accompanied by coordinated upregulation of chemokines, interferon-stimulated genes, and inflammatory cytokines. These changes were associated with increased immune cell recruitment and establishment of a more permissive tumor microenvironment.

"These data reveal a new and differentiated mechanism of action for CTX-10726, setting it apart in this exciting new class of therapeutics," said Thomas Schuetz, MD, PhD, Chief Executive Officer. "We believe PD-1 receptor cleavage results in more potent and potentially more durable checkpoint inhibition, which supports and explains what we saw in our earlier studies. The dependence of this mechanism on VEGF links a traditionally anti-angiogenic agent directly to checkpoint control and may enhance the activity of CTX-10726 within VEGF-A-rich tumor microenvironments. We are also encouraged by the combination results with CTX-471 in checkpoint-resistant models, supporting further investigation of these complementary approaches."

The Phase 1 multiple ascending dose-escalation study of CTX-10726 includes four dosing cohorts (0.3, 1.0, 3.0, and 10.0 mg/kg) in a 3+3 format. The multi-center study is enrolling post-checkpoint patients with a prioritized set of locally advanced, unresectable or metastatic malignancies, including renal cell carcinoma, gastroesophageal cancer, hepatocellular carcinoma, and endometrial cancer, in whom standard of care therapies have failed.

Details of the presentation are as follows:

Title: VEGF-dependent cleavage of cell surface PD-1 mediated by CTX-10726, a novel PD-1×VEGF-A bispecific antibody
Date & Time: Saturday, November 7, 2026 from 10:00 AM–2:00 MT PM and 6:00–8:10 MT PM
Poster number: 678
Location: Phoenix Convention Center – North Building – Lower Level – Exhibition Halls 4-5

A copy of the presentation materials can be accessed on the Compass website at View Source once the presentation has concluded.

About CTX-10726
CTX-10726 is a tetravalent PD-1 x VEGF-A bispecific antibody discovered and engineered at Compass. CTX-10726 is designed to synergistically deliver VEGF-A blockade and checkpoint inhibition, potentially applicable to multiple solid tumor indications. The bispecific antibody demonstrates a highly stable structure with high affinity target binding. CTX-10726 exhibits more potent PD-1 suppression and a novel mechanism of action compared with data reported for other drugs in the class.

(Press release, Compass Therapeutics, NOV 6, 2026, View Source [SID1234674424])

On November 6, 2026 SOTIO Biotech, a clinical-stage biopharmaceutical company owned by PPF Group, reported interim safety and efficacy results from the VICTORIA-01 Phase 1 clinical study of SOT201, a PD-1 targeting IL-15 immunocytokine, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 41st Annual Meeting taking place November 6-8, 2026, in Phoenix, AZ.

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Interim Phase 1 VICTORIA-01 data showed a 59% disease control rate with SOT201 among 22 patients with advanced solid tumors who had received a median of three prior treatment lines. Two patients achieved confirmed partial responses following prior checkpoint inhibitor therapy: an esophageal cancer response lasting 388 days and a cervical cancer response ongoing at 87 days. Most treatment-related adverse events were Grade 1 or 2. The findings supported a recommended dose of 80 µg/kg with a 20 µg/kg priming dose for further evaluation.

"Both IL-15 agonism and PD-1 inhibition have robust clinical validation in immuno-oncology, and SOT201 builds on this foundation by combining PD-1 and IL-15 mechanisms to reinvigorate antitumor T cell activities and to elicit deep antitumor immune responses," said Vivi Boura, M.D., Ph.D., chief medical officer of SOTIO. "These initial clinical data support continued evaluation of SOT201 in expanded patient cohorts, and we look forward to further characterizing its potential in challenging solid tumor types."

Presentation details are as follows:

Poster Title: "Interim safety and efficacy results of VICTORIA-01: A phase 1 study to evaluate the safety and preliminary efficacy of SOT201 in patients with advanced/metastatic solid tumors"
Poster Number: 1180
Presenter: Dr. Aung Naing, Department of Investigational Cancer Therapeutics, UT MD Anderson Cancer Center, Houston, Texas
Date: Saturday, Nov. 7, 2026

In additional poster presentations at SITC (Free SITC Whitepaper), SOTIO will share research on the localization of tertiary lymphoid structures (TLS) in immune checkpoint-resistant cancer types, as well as the role of PD-L1+ macrophages in shaping TLS organization in ovarian cancer metastases.

(Press release, SOTIO, NOV 6, 2026, View Source [SID1234674423])

On November 6, 2026 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, and its majority-owned subsidiary, BriaPro Therapeutics Corp. ("BriaPro"), reported preclinical findings from four posters at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 41th Anniversary Annual Meeting, taking place November 4-8, 2026, in Phoenix, AZ.

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The presentations highlight BriaCell’s Bria-OTS+ off-the-shelf cellular immunotherapy platform and BriaPro’s BP-80 and TILsRx immunotherapy programs, including advances in engineered CD80 proteins.

"These findings provide additional preclinical support for our cellular immunotherapy and checkpoint inhibitor programs, including Bria-BRES+ in breast cancer and Bria-PROS+ in prostate cancer," stated William V. Williams, MD, BriaCell’s President and CEO. "The results support continued development of our immunotherapy pipeline across multiple cancer indications."

Highlights of the SITC (Free SITC Whitepaper) 2026 Presentations

BriaCell

Title: A Multifaceted Genetically Engineered Whole-Cell Vaccine Platform Generates Potent, Broad, Persistent, and Effector-Centric Anti-Tumor Immunity Across Multiple Cancer Indications
Abstract Number: 863
Location: PCC-North Building-Lower Level-Exhibition Halls 4-5-6
Date: Friday, Nov. 6, 2026
Time: 12:15 – 1:45 PM, 5:30 – 7:00 PM MT

Key Findings:
Bria-OTS+ demonstrated broad innate and adaptive immune activation, including stimulating immune cells from patients with breast and prostate cancer. Priming and boosting enhanced cancer-cell killing across multiple tumor cell lines, while repeated tumor challenges demonstrated sustained cytotoxic activity. Activity was also confirmed in Bria-OTS+-activated immune cells derived from cancer patients.

BriaPro

Title: Development of BP-80, a soluble CD80 dimer (CD80-Fc) for cancer treatment
Abstract Number: 404
Location: PCC-North Building-Lower Level-Exhibition Halls 4-5-6
Date: Saturday, Nov. 7, 2026
Time: 12:00 – 1:30 PM, 6:40 – 8:10 PM MT

Key Findings:
BP-80 demonstrated CD28 co-stimulatory activity and counteracted CTLA-4-mediated inhibition in cell-based assays. In a four-week GLP nonhuman primate study, BP-80 was well tolerated, with no treatment-related pathological findings and a No Observed Effect Level (NOEL) of 50 mg/kg/dose, well above the predicted clinically active dose.

Title: Tumor-targeted checkpoint inhibitors for reactivation of tumor-infiltrating lymphocytes
Abstract Number: 405
Location: PCC-North Building-Lower Level-Exhibition Halls 4-5-6
Date: Friday, Nov. 6, 2026
Time: 12:15 – 1:45 PM, 5:30 – 7:00 PM MT

Key Findings:
TILsRx-001, a B7-H3-targeting TILsRx construct with two CD80 extracellular domains (ECD), antagonized the immune inhibitory effect of PD-L1 in a cell-based surrogate assay. Engineered with two mutations in each CD80 ECD, TILsRx-001 demonstrated a 49-fold higher binding affinity for PD-L1 than the corresponding TILsRx construct without these CD80 mutations, supporting further development of TILsRx-001 as a tumor-targeted checkpoint inhibitor.

Title: Molecular design of CD80 variants with increased affinity for PD-L1 and wild-type or lower affinity for CD28
Abstract Number: 406
Location: PCC-North Building-Lower Level-Exhibition Halls 4-5-6
Date: Saturday, Nov. 7, 2026
Time: 12:00 – 1:30 PM, 6:40 – 8:10 PM MT

Key Findings:
Structure-guided engineering generated a soluble CD80 variant (CD80-Fc) with more than 130-fold stronger PD-L1 binding than CD80-Fc with wild-type CD80 sequence. Multiple CD80 mutations enhanced PD-L1 binding with no or only minimal effect on CD28 affinity, supporting the development of CD80-based immunotherapies.

Following the presentation, copies of the posters will be made available at View Source

(Press release, BriaCell Therapeutics, NOV 6, 2026, View Source [SID1234674422])