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Immuneering Reports Second Quarter 2026 Financial Results and Provides Business Updates

On August 5, 2026 Immuneering Corporation (Nasdaq: IMRX), a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive, reported financial results for the second quarter ended June 30, 2026, and provided business updates.

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"At a time when first-line pancreatic cancer patients finally have treatment options, the 17.3 month median overall survival reported at ASCO (Free ASCO Whitepaper) for atebimetinib in combination with modified gemcitabine/nab-paclitaxel (mGnP) in our single-arm Phase 2a study stands out as potentially best-in-class. Equally important in our Phase 2a data presented at ASCO (Free ASCO Whitepaper) is that 84% of evaluable patients treated with atebimetinib + mGnP were weight stable or gained weight at three months, and only two categories of treatment related adverse events occurred at a grade 3 or higher in at least 10% of patients. In other words, debilitating side effects may not have to be a given for patients. With over 30 study locations already posted on clinicaltrials.gov, and newly published preclinical data in the peer reviewed journal Cancer Research supporting atebimetinib’s unique mechanism of action, we believe our Phase 3 MAPKeeper 301 study represents a compelling and differentiated option for first-line pancreatic cancer patients."

Recent Corporate Highlights:

Dosing patients in the Company’s pivotal Phase 3 MAPKeeper 301 trial of atebimetinib + mGnP in first-line pancreatic cancer. In June, Immuneering announced it had dosed the first patient in MAPKeeper 301, a global, randomized, open-label pivotal Phase 3 clinical trial evaluating atebimetinib + mGnP in first-line metastatic pancreatic cancer patients.

Presented compelling Phase 2a data at the ASCO (Free ASCO Whitepaper) 2026 Annual Meeting, demonstrating 17.3 month median overall survival and a favorable tolerability profile in 55 first-line pancreatic cancer patients, together with 84% of evaluable patients weight stable or gaining weight at 3 months. The Phase 2a trial is evaluating atebimetinib in combination with mGnP with results reported as of an April 24, 2026 data cutoff.

Appointed Andrew Gengos as Chief Financial Officer. In June, Immuneering announced the appointment of Andrew Gengos as Chief Financial Officer. Mr. Gengos most recently served as Chief Financial Officer and Head of Corporate Development at Terns Pharmaceuticals, which Merck & Co., Inc. acquired for $6.7 billion. Mr. Gengos will oversee financial strategy, capital allocation, investor relations, business development, and corporate development activities.

Published new findings in Cancer Research detailing atebimetinib’s broad, durable preclinical activity and favorable tolerability across RAS- and RAF-mutant tumors via Deep Cyclic Inhibition. In July, Immuneering announced the publication of an article in Cancer Research, a leading peer-reviewed journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), characterizing the differentiated mechanism and broad preclinical activity of atebimetinib. The article, "Dual-MEK Inhibitor Atebimetinib Displays Broad Activity in RAS- and RAF-Mutant Tumors via Deep Cyclic Inhibition and Resisting RAF-Bypass," reports that atebimetinib demonstrated broad antitumor activity across RAS- and RAF-mutant models while resisting RAF-mediated bypass signaling, a key mechanism associated with resistance to other MEK inhibitors. Atebimetinib’s ability to preserve body mass in a preclinical model of cancer cachexia was also highlighted in the article.

Presented Genetic Data at AACR (Free AACR Whitepaper) demonstrating mechanism to improve durability and survival, supporting use of atebimetinib in first-line pancreatic cancer and beyond. In April, Immuneering presented new genetic data in a poster presentation demonstrating a key mechanism that may improve durability and survival, supporting the use of atebimetinib as a first-line treatment in pancreatic cancer and beyond. The circulating tumor DNA (ctDNA) data from 123 atebimetinib-treated patients showed that acquired MAPK pathway alterations were rarely seen. These findings suggest that Deep Cyclic Inhibitors have the potential to overcome the limitations of conventional MAPK inhibition and provide a more sustained clinical benefit for patients, while potentially preserving sensitivity to subsequent treatments.
Anticipated Upcoming Milestones

2H 2026: Dose the first patient in Phase 2 trial of atebimetinib + anti-PD-1 (cemiplimab) in non-small cell lung cancer, with a preliminary data readout expected in late-2027.
Q4 2026: Additional preclinical data of atebimetinib in combination with anti-PD-1 in non-small cell lung cancer.
Mid-2027: Begin IND-enabling studies for our next DCI product candidate program.
Mid-2028: Topline data readout from the MAPKeeper 301 trial.
Second Quarter 2026 Financial Highlights

Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2026 were $182.7 million, compared with $217.0 million as of December 31, 2025.

Research and Development (R&D) Expenses: R&D expenses for the second quarter of 2026 were $14.0 million, compared with $10.5 million for the second quarter of 2025. The change in R&D expenses was primarily attributable to increased clinical costs related to the Company’s lead atebimetinib program and spend related to other preclinical programs, partially offset by reduced spend related to the envometinib program.

General and Administrative (G&A) Expenses: G&A expenses for the second quarter of 2026 were $5.0 million, compared with $4.3 million for the second quarter of 2025. The increase in G&A expenses was primarily attributable to employee related costs and increased software costs supporting the general and administrative functions of the business.

Net Loss: Net loss attributable to common stockholders was $17.3 million, or $0.27 per share, for the second quarter ended June 30, 2026, compared to $14.4 million, or $0.40 per share, for the second quarter ended June 30, 2025. 

2026 Financial Guidance

Based on cash, cash equivalents and marketable securities as of June 30, 2026, and current operating plans, the Company expects its cash runway to be sufficient to fund operations into 2029.

(Press release, Immuneering, AUG 5, 2026, View Source [SID1234669757])

BriaCell Receives FDA Clearance to Initiate Bria-PROS+™ Clinical Study in Prostate Cancer

On August 5, 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, reported that the U.S. Food and Drug Administration (FDA) has completed its review of the Investigational New Drug (IND) application for Bria-PROS+ and issued a Study May Proceed letter, clearing the way for clinical evaluation of Bria-PROS+, its next generation, personalized, off-the-shelf, cell-based immunotherapy for prostate cancer.

"We are pleased to announce FDA clearance of the IND for Bria-PROS+, our next-generation personalized immunotherapy for prostate cancer," stated Dr. William V. Williams, BriaCell’s President & CEO. "Bria-PROS+ is designed to activate multiple components of the immune system, which we believe has the potential to support meaningful therapeutic benefit with a favorable safety profile. We look forward to advancing Bria-PROS+ into the clinic as we work to develop new treatment options for patients with advanced prostate cancer."

In August 2025, BriaCell was awarded a $2 million non-dilutive grant from the US National Cancer Institute to support the manufacturing and planned clinical evaluation of Bria-PROS+.

As reported in BriaCell’s preclinical poster presentation, at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, Bria-PROS+ demonstrated activation of both adaptive and innate immune responses including activation of naïve (resting) T-cells, dendritic cells and natural killer (NK) cells. BriaCell believes this multipronged immune activation may enhance clinical efficacy and help prevent immune escape in patients with prostate cancer.

BriaCell’s Bria-PROS+ builds on the Company’s oncology platform with its Bria-IMT program, currently in its Phase 3 pivotal trial for metastatic breast cancer, its Bria-OTS breast cancer clinical program, in which the first patient dosed experienced sustained complete resolution of a lung metastasis, and its Bria-BRES+ program, which recently received FDA clearance to initiate clinical evaluation of its enhanced, personalized, off-the-shelf cellular immunotherapy for breast cancer. Bria-PROS+, Bria-OTS and Bria-BRES+ programs are personalized immunotherapies, based on HLA matching between patients and the respective immunotherapy cell lines.

(Press release, BriaCell Therapeutics, AUG 5, 2026, View Source [SID1234669756])

Leads Biolabs’ Opamtistomig (PD-L1/4-1BB Bispecific Antibody) Advances to Expansion Phase in First-Line Hepatocellular Carcinoma Following Positive Efficacy Signals

On August 5, 2026 Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK) reported that its Phase II clinical study evaluating Opamtistomig (LBL-024), a proprietary PD-L1/4-1BB bispecific antibody, in combination with bevacizumab for the treatment of first-line hepatocellular carcinoma (HCC) has successfully completed the safety run-in phase assessment following expert review and has advanced into the expansion phase. The study is led by Professor Zhou Jian, President of Zhongshan Hospital, Fudan University, and Academician of the Chinese Academy of Sciences.

Preliminary clinical data demonstrated that Opamtistomig in combination with bevacizumab has shown encouraging anti-tumor activity and a favorable safety profile in patients with HCC, supporting further clinical evaluation in the expansion phase.

HCC represents a significant global health burden and is the fourth most common malignant tumor and the second leading cause of cancer-related mortality in China, with approximately 368,000 new cases and 317,000 deaths recorded annually. Due to its often insidious onset, fewer than 30% of patients are eligible for potentially curative treatment at diagnosis, making systemic anti-tumor therapies essential for patients with intermediate-to-advanced disease.

Currently, PD-1/PD-L1 inhibitors in combination with bevacizumab have become one of the first-line standard treatments for advanced HCC both in China and globally; however, median overall survival is only approximately 19 to 20 months, median progression-free survival is less than 7 months, and the objective response rate does not exceed 30%. These limitations highlight the urgent need for more effective and durable treatment strategies.

Opamtistomig has demonstrated promising efficacy signals and broad therapeutic potential across multiple tumor types, including extrapulmonary neuroendocrine carcinoma (EP-NEC), non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC) and biliary tract cancer (BTC). Powered by the proprietary X-body platform, which enables tumor-localized activation of 4-1BB signaling, Opamtistomig has maintained a favorable safety profile across nearly 800 treated patients, further supporting its potential as a next-generation IO 2.0 pan-tumor immunotherapy platform. The encouraging clinical findings in HCC further strengthen the clinical validation of Opamtistomig’s differentiated mechanism and therapeutic potential.

Executive Commentary
Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, said: "Advancing this Phase II study of Opamtistomig in first-line HCC into expansion phase is an important milestone in validating its potential as a pan-tumor immunotherapy. While PD-1/PD-L1-based combination therapies have become the standard of care for first-line HCC, significant unmet medical needs remain. The encouraging efficacy signals observed with Opamtistomig in combination with bevacizumab provide further confidence in its potential to improve treatment outcomes for patients with HCC. We will continue to accelerate clinical development and global registration efforts to bring this innovative therapy to patients worldwide as quickly as possible."

About HCC
According to data published by the World Health Organization ("WHO"), the global annual number of new HCC cases reached 865,000 in 2022, ranking sixth among malignant tumors, with 758,000 deaths, ranking third among malignant tumors. HCC is particularly prevalent in China, where it is the fourth most common malignant tumor and the second leading cause of cancer-related deaths. Although China’s population accounts for only 18.4% of the global population, the country accounts for 368,000 new HCC cases and 317,000 deaths annually, representing 42.5% and 41.8% of the global totals, respectively.

HCC is the predominant type of primary liver cancer, accounting for approximately 85% to 90% of cases. It has an insidious onset and is highly aggressive, with most patients diagnosed at an intermediate to advanced stage and a correspondingly poor prognosis. The five-year survival rate is 15% to 19% in North America, compared with only 12.1% in China, posing a serious threat to the health and lives of the Chinese population and making the reduction of the HCC disease burden a major public health issue requiring urgent attention in China.

About Opamtistomig
Opamtistomig (LBL-024) is emerging as a next-generation pan-cancer backbone therapy with potential overall survival (OS) benefit that simultaneously targets PD-L1 and the co-stimulatory receptor 4-1BB. Developed using Leads Biolabs’ proprietary X-Body bispecific platform, Opamtistomig is designed to simultaneously block PD-1/L1 immune suppression and conditionally activate 4-1BB, an agonist pathway, resulting in a potent and synergistic anti-tumor immune response. It has a safety profile comparable to PD-1/PD-L1 inhibitors and demonstrates broader-spectrum anti-cancer potential. To date, Opamtistomig has demonstrated first- or best-in-class potential in Phase II or registrational clinical trials across four indications: non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), biliary tract cancer (BTC), and extrapulmonary neuroendocrine carcinoma (EP-NEC).

As the first 4-1BB–targeting bispecific antibody globally to advance to a single-arm pivotal trial as monotherapy, Opamtistomig has been evaluated in 13 solid tumor indications in China, including 1 pivotal registration trial and 8 proof-of-concept studies. These cover EP-NEC, NSCLC, SCLC, BTC, ovarian cancer (OC), esophageal squamous cell carcinoma (ESCC), hepatocellular carcinoma (HCC), gastric cancer (GC), triple-negative breast cancer (TNBC), malignant melanoma, and other areas with high unmet medical needs.

Mechanistically, 4-1BB agonism can reactivate exhausted T cells and promote robust T-cell proliferation, offering significant promise for PD-1/PD-L1–resistant or immunologically "cold" tumors. Recognizing its clinical potential, Opamtistomig received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) in October 2024, and Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of neuroendocrine carcinoma in November 2024. Additionally, in January 2026, Opamtistomig was granted Fast Track Designation (FTD) by the FDA and ODD by the European Commission for the treatment of EP-NEC, further underscoring its potential to address unmet medical needs in this patient population.

(Press release, Nanjing Leads Biolabs, AUG 5, 2026, View Source [SID1234669755])

Notice of acceptance of patent in Australia

On August 5, 2026 Fusion Antibodies plc (AIM: FAB), specialists in pre-clinical antibody discovery, engineering and supply for both therapeutic drug and diagnostic applications, reported that IP Australia has issued a notice of acceptance in respect of the Company’s Australian patent application no. 2019365135 (the "Patent Application").

The Patent Application entitled "Antibody Library and Method", covers two families of antibodies, and the methods for designing such antibody libraries. The patent, once granted, is expected to be complementary to Fusion’s offering to provide "Opti" designed antibody libraries for a range of applications including: Antibody Discovery; Affinity Maturation; and Sequence Optimisation.

The Company continues to progress additional patent applications in respect of the OptiMAL Library in several other territories worldwide including Europe and China.

Receipt of a notice of acceptance indicates that the claims in the Patent Application are patentable and does not in itself represent a grant of patent rights. Fusion anticipates that the patent will be granted in due course, following completion of certain administrative requirements, including payment of the applicable fees, and the successful completion of a three-month gazetting period.

(Press release, Fusion Antibodies, AUG 5, 2026, View Source [SID1234669754])

Adicet Bio Reports Second Quarter 2026 Financial Results and Provides Business Updates

On August 5, 2026 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, reported financial results and operational highlights for the second quarter ended June 30, 2026.

"At Adicet, we continue to advance prula-cel toward our next important clinical milestone, with a Phase 1 clinical update now expected in the third quarter of 2026. The additional follow-up time will allow us to deliver a more comprehensive and mature dataset, including 22 LN/SLE patients with a minimum of 6 months of follow-up, 13 of whom are expected to have reached at least 12 months of follow-up," said Chen Schor, President and Chief Executive Officer of Adicet Bio. "We also had productive interactions with the FDA to align on overall clinical design for a potential pivotal trial for prula-cel in LN, further supporting a clear regulatory path forward. Furthermore, we anticipate sharing additional clinical updates for prula-cel in the second half of 2026 in patients with systemic sclerosis."

Mr. Schor continued, "Beyond prula-cel, we are continuing to advance ADI-212 toward Phase 1 alongside our differentiated in vivo CAR-T platform and pipeline targeting hematologic malignancies and solid tumors. With several planned milestones ahead in 2026, including anticipated clinical data readouts in LN and SLE in the third quarter, clinical data in systemic sclerosis in the second half of the year, and an update on our in vivo CAR T platform and pipeline, we look forward to executing our strategic priorities and positioning the company for long-term value creation."

Second Quarter 2026 and Recent Operational Highlights:

Autoimmune diseases

Phase 1 prula-cel clinical update in LN and SLE patients expected in 3Q/2026. The Company plans to provide its next clinical update in the third quarter of 2026 for its ongoing Phase 1 clinical trial evaluating prula-cel across multiple autoimmune conditions. The update is expected to include data from 22 patients with LN and SLE (16 LN/ 6 SLE) who will have at least 6 months of follow-up, including 13 patients who are expected to have reached at least 12 months of follow-up. Following alignment with the FDA in November 2025, LN and SLE patients in current and future studies may be dosed with prula-cel in an outpatient setting.
Productive FDA interactions to align on overall design for potential pivotal trial design. Based on recent interactions with the FDA, the Company is advancing a potential pivotal trial design in LN and supporting planned start-up activities for a pivotal program anticipated to commence in the second half of 2026, subject to regulatory clearance. The Company plans to provide more details on the potential pivotal trial design as part of its comprehensive clinical update anticipated in the third quarter of 2026.
Solid tumor indications

Regulatory submission for ADI-212 expected in the third quarter of 2026, with Phase 1 initiation anticipated in the fourth quarter of 2026, pending regulatory clearance. Adicet continues to advance ADI-212, its next-generation gene-edited, armored cell therapy candidate targeting prostate-specific membrane antigen (PSMA), engineered with a novel CAR binder designed to enhance tolerability and tumor specific recognition. The program combines membrane tethered IL-12 armoring and CRISPR/Cas9-mediated disruption of subunit 12 of the mediator complex (MED12) designed to improve potency in solid tumors and enable multiple anti-tumor mechanisms within the tumor microenvironment. Adicet expects to submit a regulatory filing for ADI-212 for the treatment of mCRPC in the third quarter of 2026, with initiation of Phase 1 enrollment anticipated in the fourth quarter of 2026, subject to regulatory clearance.
In Vivo CAR-T Program and Pipeline

Advancing innovation through a differentiated cell therapy platform. Adicet is developing a differentiated in vivo CAR-T platform and pipeline targeting hematologic malignancies and solid tumors. A comprehensive update on the platform and pipeline is anticipated in the second half of 2026.
Corporate Update

Lloyd Klickstein, M.D., Ph.D. appointed Interim Chief Medical Officer. Following the departure of Dr. Julie Maltzman, Dr. Klickstein, who currently serves on the board of the Company, has been appointed Interim Chief Medical Officer and will lead all clinical development and medical affairs activities while the Company conducts a search for a permanent Chief Medical Officer. Dr. Klickstein is a physician-scientist and biotechnology executive with more than 20 years of experience in rheumatology, immunology and translational medicine. He completed clinical training in rheumatology and immunology at the Brigham and Women’s Hospital and has held senior leadership roles at Novartis, Versanis Bio, which was acquired by Eli Lilly, Adicet Bio, and currently serves as Board Chair of the Lupus Foundation of New England and CEO of Koslapp Therapeutics.
Financial Results for Second Quarter 2026:

Research and Development (R&D) expenses were $18.5 million for the three months ended June 30, 2026. Non-cash stock-based compensation expense included in R&D expense was $0.9 million for the second quarter of 2026.
General and Administrative (G&A) expenses were $3.9 million for the three months ended June 30, 2026. Non-cash stock-based compensation expense included in G&A expense was $0.6 million for the second quarter of 2026.
Net loss was $21.4 million, or a net loss of $1.99 per basic and diluted share for the three months ended June 30, 2026. This net loss includes non-cash charges of $2.8 million that consisted primarily of share-based compensation, depreciation expenses, and noncash lease expense.
Cash, cash equivalents and short-term investments were $118.2 million as of June 30, 2026. The Company expects that current cash, cash equivalents and short-term investments as of June 30, 2026, will be sufficient to fund its operating expenses into the second half of 2027.

(Press release, Adicet Bio, AUG 5, 2026, View Source [SID1234669753])