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Calidi Biotherapeutics Provides Mid-Year Corporate Update and Future Key Value Drivers

On July 21, 2026 Calidi Biotherapeutics, Inc. (NYSE American: CLDI) ("Calidi" or the "Company"), a clinical-stage biotechnology company pioneering the development of systemically delivered, targeted genetic medicines, reported 2026 successes to date and provided an update on the Company’s upcoming milestones.

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"Calidi continues to execute on its goal of bringing its RedTail platform to the clinic and expanding the utility of this groundbreaking technology," said Calidi Chief Executive Officer Eric Poma, PhD. "We have had productive discussions with the FDA that support our strategy and timeline for CLD-401 IND filing and we continue to expand the reach of RedTail with the development of in situ TCEs."

1H26 Accomplishments

Successful pre-IND meeting with FDA with agreement on pharmacology, toxicology, CMC, and phase I protocol strategy for CLD-401 phase I trial
In Situ TCEs have the potential to overcome current limitations around T-cell engagers in solid tumors by their ability to deliver high levels of a TCE in situ while simultaneously activating T-cells in the tumor microenvironment. Proof-of-concept data presented in 2026 underscore this potential
Strengthened the Board of Directors with the addition of Corsee Sanders, Ph.D. Dr. Sanders has served as strategic advisor to Celgene’s Chief Medical Officer (CMO) following Celgene’s acquisition of Juno where she was an Executive Vice President of Development Operations. She also served as Transition Advisor to Bristol Myers Squibb (BMS), which acquired Celgene. Prior to that, Dr. Sanders held numerous leadership positions over the course of 23 years at Genentech/Roche, including serving as Senior Vice President, Global Head of Clinical Operations and Industry Collaboration, for six years
Reduced debt and G&A expenses by approximately $1M in 1Q26 over 1Q25. Company will maintain a continued focus on cost cutting to ensure sufficient capital to advance pipeline
Upcoming Key Value Drivers

New data to be presented quantifying positive results from cytotoxicity and IL-15 SA expression in murine tumor cells at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Drug Discovery and Development (AACR D3) conference being held in Boston, MA from July 21-24, 2026
New data to be presented expanding in situ TCEs from the RedTail platform to include EpCAM-targeted TCEs, in addition to TROP-2, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) conference being held in Madrid, Spain from October 23-27, 2026
New data to be presented including results from GLP toxicity and IND-enabling studies, as agreed to with the FDA at June 2026 pre-IND meeting, at the Society for Immunology of Cancer (SITC) (Free SITC Whitepaper) conference being held in Phoenix, AZ from November 4-8, 2026
Company targeting first patient dosed in CLD-401 phase I trial in Q1 2027. On track for regulatory submissions with positive feedback from FDA in pre-IND meeting
First patients’ data in CLD-401 trial anticipated in Q2 2027. The Company believes that early signs of activity and expression in tumor microenvironment (TME) would prove the platform is working as designed and viral and protein payloads are being effectively deployed in the TME

(Press release, Calidi Biotherapeutics, JUL 21, 2026, View Source [SID1234669358])

European Patent Office Confirms Patent Protection for SOT201, SOTIO’s Clinical-Stage Immunocytokine Showing Promising Anti-Tumor Activity

On July 21, 2026 SOTIO Biotech, a clinical-stage biopharmaceutical company owned by PPF Group, reported that the Boards of Appeal of the European Patent Office (EPO) have upheld European Patent EP 3 444 271 B1, reinforcing intellectual property protection for SOT201, the company’s next-generation PD-1-targeting immunocytokine currently being evaluated in a Phase 1 clinical trial. The decision strengthens the intellectual property foundation supporting a program that has already demonstrated a high disease control rate, including objective responses in heavily pre-treated cancer patients.

During oral proceedings held in the beginning of July, the Boards of Appeal confirmed the validity of the patent and upheld the earlier Opposition Division decision maintaining the patent as granted. The patent is co-owned by Cytune Pharma (an affiliate of SOTIO Biotech), AP-HP (Assistance Publique – Hôpitaux de Paris), and INSERM (Institut National de la Santé et de la Recherche Médicale). Opposition proceedings were initiated by Sanofi and Strawman Limited, and the subsequent appeal was filed by Sanofi.

The patent covers immunocytokines comprising a conjugate of interleukin-15 (IL-15) with the sushi domain of the IL-15 receptor alpha and an immunomodulatory antibody, including PD-1 antagonists. The decision further strengthens protection of SOTIO’s proprietary immunocytokine platform and the SOT201 program.

"We are pleased that the Boards of Appeal have upheld this important patent," said Radek Spisek, M.D., Ph.D., chief executive officer of SOTIO. "The decision validates the strength of the underlying invention and reinforces the intellectual property supporting SOT201. Importantly, this milestone comes as the program continues to generate encouraging clinical data, including objective responses in heavily pre-treated patients, underscoring the potential of this novel immunocytokine approach."

SOT201 is a PD-1-targeted, cis-acting attenuated IL-15 agonist designed to preferentially activate PD-1+CD8+ T cells and enhance anti-tumor immune responses. The investigational therapy is currently being evaluated in the international Phase 1 VICTORIA-01 study in patients with advanced unresectable or metastatic solid tumors.

(Press release, SOTIO, JUL 21, 2026, View Source [SID1234669357])

Lonza and Engitix Announce License Agreement to Advance Targeted ADC Development

On July 21, 2026 Lonza, the world’s leading contract development and manufacturing organization (CDMO), and Engitix, a global leader in ECM-based drug discovery and development, reported a licensing agreement to advance the development of antibody-drug conjugates (ADCs) and deliver life-changing therapies for patients with chronic diseases.

Under the agreement, Engitix will access Lonza’s ADC technology platform through a single-target license, including the use of SYNtecan E linker-payload and complementary GlycoConnect and HydraSpace. These technologies will support Engitix’s goal to develop and commercialize therapies. Lonza, through one of its affiliated companies, is eligible to receive upfront, clinical, regulatory, and commercial milestone payments, plus royalties on net sales of resulting products. Lonza is responsible for manufacturing components that are related to its proprietary technologies, and Engitix is responsible for the research, development, manufacturing, and commercialization of the ADCs.

Engitix has developed a proprietary human ECM platform that allows the study of disease biology directly in human tissue. This approach focuses on targets within the ECM itself, offering a differentiated pathway compared to traditional methods that focus on cell surface targets.

The collaboration enables Engitix to leverage Lonza’s established ADC technology platform to develop differentiated therapeutic candidates designed to selectively deliver potent payloads to tumor-selective targets identified through Engitix’s proprietary human ECM discovery platform.

Jan Vertommen, Vice President of Commercial Development, Advanced Synthesis, Lonza, commented: "We are pleased to collaborate with Engitix on this innovative program. By combining our ADC development and manufacturing expertise with Engitix’s unique ECM-based discovery platform, we aim to advance next-generation ADCs and unlock new possibilities in targeted therapies for patients."

Dr. Giuseppe Mazza, CEO and Co-Founder, Engitix, added: "At Engitix, we are committed to translating our unique understanding of the disease microenvironment into transformative therapies for patients with high unmet medical need. Licensing Lonza’s clinically validated conjugation and linker-payload technologies provides us with a powerful toolkit to develop next-generation ECM-targeted therapeutics with the potential for enhanced efficacy, reduced toxicity and improved therapeutic index."

The license agreement represents an important step in Engitix’s strategy to build a diversified pipeline of precision therapeutics addressing fibrosis, oncology, and other diseases driven by pathological tissue remodeling.

(Press release, Lonza, JUL 21, 2026, View Source [SID1234669356])

IMUNON Reports Positive Phase 2 MRD Clinical Data for IMNN-001, Demonstrating the Successful Overcoming of Historical IL-12 Safety Barriers in Frontline Ovarian Cancer

On July 21, 2026 IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, reported new positive preliminary data from its ongoing Phase 2 minimal residual disease (MRD) translational clinical trial of IMNN-001, conducted in combination with standard of care neoadjuvant and adjuvant chemotherapy (N/ACT) plus bevacizumab, in women with newly diagnosed advanced ovarian cancer.

This cutting-edge translational study is being conducted through the Break Through Cancer Targeting Minimal Residual Disease in Ovarian Cancer TeamLab, a multi-institutional collaboration accelerating research in ovarian cancer. The multi-site study is led by investigators at The University of Texas (UT) MD Anderson Cancer Center, which serves as the lead clinical site. Its objectives include understanding how chemo-immunotherapy with IMNN-001 impacts ovarian cancer’s "cold" tumor microenvironment and MRD after frontline treatment.

Nine patients in each of the control and experimental arms (total target accrual of 30 patients, 15 in each arm) have reached second-look laparoscopy (SLL), the study’s primary assessment point for surgical MRD. Compared to control, preliminary results show a deeper antitumor response, as demonstrated by a lower MRD-positive rate, in patients treated with IMNN-001 (44% vs. 67%), a higher rate of circulating tumor DNA (ctDNA) clearance (87.5% vs. 62.5%), and a numerically higher rate of patients achieving no evidence of disease (NED) following frontline therapy (100% vs. 56%).

"We are encouraged by these new data points from our MRD study, which continue to build the case for IMNN-001’s potential to make a meaningful difference for women with newly diagnosed advanced ovarian cancer," said Stacy Lindborg, Ph.D., President and Chief Executive Officer of IMUNON. "These findings, together with the consistent safety profile we’ve now observed across multiple studies, reinforce that we have overcome the historical safety and efficacy barriers associated with the development of a novel IL-12 immunotherapy and further bolster our confidence in IMNN-001 as we continue to advance our pivotal Phase 3 OVATION 3 trial."

"These new findings from the MRD study add an important layer of evidence to what we’ve observed with IMNN-001 to date," said study principal investigator, Amir Jazaeri, M.D., professor of Gynecologic Oncology and Reproductive Medicine at UT MD Anderson. "The reduction in residual disease and the encouraging ctDNA clearance we’re seeing, together with a consistent safety and tolerability profile, strongly support the continued investigation of IMNN-001’s role in the frontline treatment of ovarian cancer."

These new MRD findings build on results from the Company’s completed Phase 2 OVATION 2 study, in which IMNN-001 was associated with a 14.7-month increase in median overall survival compared to chemotherapy alone (45.1 vs. 30.4 months), and a 24.2-month increase among patients who also received PARP inhibitor maintenance therapy (65.6 vs. 41.4 months). The positive tolerability profile of IMNN-001 observed in prior studies has continued in the MRD study, including in combination with standard-of-care chemotherapy plus bevacizumab and in the maintenance setting, with no cytokine release syndrome, systemic toxicities, or serious immune-related adverse events observed to date. IMNN-001 is now being evaluated in the Company’s pivotal Phase 3 OVATION 3 trial, enrolling patients with newly diagnosed advanced ovarian cancer at clinical sites across the U.S.

Reinforcing previously published phase 2 data, new translational data from the MRD study also continue to support IMNN-001’s proposed mechanism of action. IMNN-001 induces robust expression of IL-12 in macrophages within the peritoneal fluid and tumor tissue, stimulating a cascade of anti-tumor cytokines, including interferon-gamma, and resulting in potent macrophage and T cell activation. These findings are consistent with a shift in the tumor immune microenvironment from "cold" to "hot," activating both innate and adaptive immune responses.

"We remain focused on generating a comprehensive body of evidence for IMNN-001 across our clinical program," added Dr. Lindborg. "The MRD study, together with our Phase 2 OVATION 2 results and the ongoing pivotal Phase 3 OVATION 3 trial, continues to build a consistent picture of IMNN-001’s benefit-risk profile in frontline ovarian cancer treatment."

About the Translational Phase 2 MRD Study

The Phase 2 MRD study (NCT05739981) is evaluating IMNN-001 in combination with standard-of-care neoadjuvant and adjuvant chemotherapy plus bevacizumab in women with newly diagnosed advanced ovarian cancer, conducted through the Break Through Cancer Targeting Minimal Residual Disease in Ovarian Cancer TeamLab. Patients in the experimental arm receive IMNN-001, administered intraperitoneally, in combination with N/ACT plus bevacizumab, followed by interval cytoreductive surgery and additional cycles of adjuvant chemotherapy plus IMNN-001. Patients then undergo second-look laparoscopy (SLL) to assess for minimal residual disease, followed by maintenance therapy assigned according to homologous recombination deficiency (HRD) status. The primary endpoint of the study is MRD-positive rate at SLL; the secondary endpoint is progression-free survival (PFS). The study also includes serial translational analyses of tumor tissue, circulating tumor DNA (ctDNA), microbiome, and intraperitoneal fluid, to further characterize IMNN-001’s impact on the tumor immune microenvironment.

About IMNN-001 Immunotherapy

Designed using IMUNON’s proprietary TheraPlas platform technology, IMNN-001 is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anticancer immunity, acting through the induction of T-lymphocyte and natural killer cell proliferation. IMUNON previously reported positive safety and encouraging Phase 1 results with IMNN-001 administered as monotherapy or as combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer, and completed a Phase 1b dose-escalation trial (the OVATION 1 Study) of IMNN-001 in combination with carboplatin and paclitaxel neoadjuvantly in patients with newly diagnosed ovarian cancer. IMUNON previously reported positive results from the completed Phase 2 OVATION 2 Study, which assessed IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (N/ACT) of paclitaxel and carboplatin compared to standard-of-care N/ACT alone in 112 patients with newly diagnosed advanced ovarian cancer.

About Epithelial Ovarian Cancer

Epithelial ovarian cancer is the sixth deadliest malignancy among women in the U.S. There are approximately 20,000 new cases of ovarian cancer every year and approximately 70% are diagnosed in advanced stage III/IV. Epithelial ovarian cancer is characterized by dissemination of tumors in the peritoneal cavity with a high risk of recurrence (75%, stage III/IV) after surgery and chemotherapy. Since the five-year survival rates of patients with stage III/IV disease at diagnosis are poor (41% and 20%, respectively), there remains a need for a therapy that not only reduces the recurrence rate but also improves overall survival. The peritoneal cavity of advanced ovarian cancer patients contains the primary tumor environment and is an attractive target for a regional approach to immune modulation.

(Press release, IMUNON, JUL 21, 2026, View Source [SID1234669355])

Nurix Therapeutics Announces HSR Clearance of Global Collaboration with Roche to Co-Develop and Co-Commercialize Potential Best-in-Class BTK Degrader Bexobrutideg Across Malignant Hematology, Immunology and Neurology

On July 21, 2026 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, reported the closing of its previously announced global collaboration agreement with Roche to co-develop and co-commercialize bexobrutideg, following expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

Summary of Business Terms
Under the terms of the agreement, Nurix will receive an upfront cash payment of $700 million and is eligible to receive development, regulatory and sales milestones for potential total payments of up to $2.3 billion. Development costs will be shared 40% by Nurix and 60% by Roche. The parties will equally split the profits and losses from U.S. commercialization. Nurix and Roche will co-commercialize bexobrutideg in the United States across all indications. Outside of the United States, Roche will be responsible for commercialization, with Nurix eligible to receive royalties ranging from the low- to high-teens. Nurix and Roche will jointly advance a broad clinical development program for bexobrutideg, including ongoing and planned studies in chronic lymphocytic leukemia (CLL), additional B-cell malignancies, multiple sclerosis (MS) and chronic spontaneous urticaria (CSU).

"This global collaboration marks a transformational moment for Nurix and the field of targeted protein degradation," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. "With Roche as our partner, we are uniquely positioned to realize the full potential of bexobrutideg across oncology, immunology and neurology. Roche’s global development and commercial capabilities, combined with Nurix’s leadership in targeted protein degradation, provide the resources, expertise and shared commitment needed to rapidly advance bexobrutideg for patients who continue to face significant unmet medical needs. We are excited to begin this next chapter and to execute on what we believe is one of the most ambitious development programs ever undertaken for a degrader medicine."

About Bexobrutideg (NX-5948)
Bexobrutideg (NX-5948) is an investigational, orally bioavailable, brain-penetrant, highly selective small-molecule degrader of Bruton’s tyrosine kinase (BTK) being developed by Nurix and Roche as a potential best-in-class therapy across oncology, immunology and neurology.

Bexobrutideg is currently being evaluated in the DAYBreak CLL-201 clinical trial (NCT07221500), a pivotal single-arm Phase 2 study in patients with relapsed/refractory CLL, and in the NX-5948-301 Phase 1a/1b clinical trial (NCT05131022) in patients with relapsed/refractory B-cell malignancies. Additional trials are planned, including the DAYBreak CLL-306 clinical trial (NCT07516093), a randomized Phase 3 trial comparing bexobrutideg to pirtobrutinib in patients with relapsed/refractory CLL, and the NX-5948-203 Phase 1/2 clinical trial (NCT07520006), assessing the combination of bexobrutideg with venetoclax with or without an anti-CD20 antibody in patients with relapsed/refractory CLL and treatment naïve CLL. A new tablet formulation of bexobrutideg is being evaluated in a first-in-human single-ascending-dose and multiple-ascending-dose study in healthy volunteers (NCT06717269) to support future development in immunology and neurology indications. Additional information about these clinical trials can be found at clinicaltrials.gov.

(Press release, Nurix Therapeutics, JUL 21, 2026, View Source [SID1234669354])