Dj Mustang Bio Inc Com, Inst Holders, 3Q 2025 (Mbio)

Net loss narrowed to $1.4M for the nine months ended September 30, 2025, with cash reserves at $19.0M following equity offerings and warrant exercises. Substantial doubt remains about the ability to continue as a going concern without further capital, and the company faces ongoing operational, regulatory, and financing risks.

Original document: Mustang Bio, Inc. [MBIO] SEC 10-Q Quarterly Report — Nov. 7 2025

Net loss narrowed significantly year-over-year due to cost reductions, but substantial doubt remains about the ability to continue as a going concern without additional capital. Cash on hand was $12.7 million, with ongoing fundraising efforts and key clinical programs targeting 2026 trial initiations.

Original document: Mustang Bio, Inc. [MBIO] SEC 10-Q Quarterly Report — Aug. 8 2025

PALM BEACH, Fla., July 08, 2025 (GLOBE NEWSWIRE) — FN Media Group News Commentary - The global oncology market, including breakthrough treatments, is experiencing substantial growth, with revenues projected to reach hundreds of billions of dollars in the coming years. Several factors are driving this expansion, including rising cancer incidence, advancements in therapies like precision medicine and immunotherapy, and increased investment in research and development. A report from Grand View Research said that the global breakthrough therapy designation market size is projected to grow at a CAGR of 14.2% through 2030. It is a process designed to escalate the development and assessment of sanctioning of drugs & biologics that are proposed for treating severe diseases, whereas primary clinical evidence notifies that the drug determines considerable enhancement over existing therapy on a clinically significant endpoint. Furthermore, the BT (Breakthrough) designation lets pharma companies hasten the developmental process by offering additional support and assistance from the FDA and making medications available to the public faster. The report continued: “Apart from breakthrough designation therapy, there are some important tools, all of which have been in place for many years, such as fast-track designation, accelerated approval, and priority review. All of these are inclined toward approving drugs used to treat serious disorders. Although these processes can reduce a drug's time to market, standard clinical testing is required for the development process, which usually involves three phases of large-scale and controlled trials.” Active oncology biotech and pharma companies in the markets this week include Oncolytics Biotech® Inc. , Mustang Bio, Inc. , Verastem Oncology , Cardiff Oncology, Inc. , AstraZeneca PLC .

Grand View Research continued: “The increasing prevalence of life-threatening conditions and the necessity for the rapid development of pipeline drugs are also some factors that propel the breakthrough therapy drug market. This is primarily driven by the significant unmet need for effective treatments for severe conditions currently available. Manufacturing companies are particularly attentive to drugs designated as breakthrough therapies due to the accelerated market access and higher returns on investment. Breakthrough therapy drugs often undergo less extensive clinical trials, which is a direct consequence of their market designation. The FDA's enhanced support for small-scale industries in research and development, including increased funding and expedited drug approval processes, is further stimulating the market for breakthrough therapy drugs. Collectively, these elements are pushing the breakthrough therapy drug market forward. Further, innovative gene and cell therapies are offering new treatment decisions for previously untreatable illnesses, mainly drifting to more breakthrough therapy designations. Moreover, the regulatory support agencies are streamlining processes and offering assistance for breakthrough therapies to speed up their development and sanction. Another aspect leading the breakthrough therapy designations is the cross-sector collaborations between academic institutions, pharmaceutical companies, and research institutes that are lifting the upgradation and the advancement of new breakthrough therapies completely.”

Oncolytics Biotech® Inc. Highlights Transformative Pelareorep Survival Data in Multiple Tumors and Commitment to Registration-Enabling Studies

• Comparison with multiple landmark first-line metastatic pancreatic ductal adenocarcinoma studies substantiates strong two-year survival benefit of 21.9% vs. 9.2% historical benchmark
• Consistent survival benefit compared to standard-of-care chemotherapy in randomized studies in the large HR+/HER2- metastatic breast cancer indication
• Data from over 1,100 patients across tumor types reveals a favorable, well-understood safety profile

-- Oncolytics Biotech ® Inc. ($ONCY $ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced a strategic update highlighting its compelling clinical data from two tumor types and outlining a sharpened focus on advancing pelareorep, the Company’s intravenously delivered oncolytic virus immunotherapy, into registration-enabling studies.

“We are no longer in the business of funding proof-of-concept studies,” said Jared Kelly, Chief Executive Officer of Oncolytics. “We have meaningful clinical data in hand—not just signals. The survival benefit across multiple tumor types demands a focused approach to take pelareorep directly into registration-enabling trials. We will use our fast-track status to find the most efficient regulatory path forward this summer to advance our platform in a product technology.”

Results from two completed first-line metastatic pancreatic ductal adenocarcinoma (mPDAC) trials demonstrate a strong and consistent efficacy signal showing extremely rare 2-year overall survival rates of 21.9% vs. 9.2% based on pooled data from over 100 patients across two studies evaluating pelareorep combined with a chemotherapy backbone. In addition, a best-in-class 62% objective response rate (ORR) was observed in a single-arm study of pelareorep in combination with a chemotherapy backbone and a checkpoint inhibitor in 13 evaluable patients. These results collectively represent promising efficacy for a therapeutic regimen that includes an immunotherapy in this difficult-to-treat cancer. Currently, there are no approved immunotherapies for first-line treatment of mPDAC…

…Pelareorep’s clinical activity in HR+/HER2- metastatic breast cancer – a large indication with continued significant unmet medical need and no currently approved immunotherapies – has been demonstrated in two randomized phase 2 studies, both of which showed a median overall survival (mOS) benefit of greater than 10 months compared to standard-of-care chemotherapy (IND.213 mOS: 21.0 vs. 10.8 months; BRACELET-1 mOS: not statistically reached; conservative estimate = 32.1 months vs. 18.2 months). In the randomized, controlled BRACELET-1 study, pelareorep combined with paclitaxel yielded a 12.1-month median progression-free survival (PFS) compared to 6.4 months in the paclitaxel alone control arm.

“Pelareorep represents a tipping point for immunotherapy in cold tumors,” said Dr. Thomas Heineman, Chief Medical Officer of Oncolytics. “It is delivering consistent immunologic and clinical responses in multiple tumor types. Most impressively, pelareorep activates the immune system to produce clinical benefits in cancers that are typically unresponsive to immunotherapies like mPDAC and unresectable HR+/HER2- breast cancer, creating new oncology entry points for immune-based combination therapies.” CONTINUED… Read these full press releases and more news for ONCY at: https://www.financialnewsmedia.com/news-oncy/

Other recent oncology developments in the biotech industry of note include:

Mustang Bio, Inc. , a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell therapies into potential cures for difficult-to-treat cancers, recently announced that the U.S. Food and Drug Administration (“FDA”) has granted Orphan Drug Designation to Mustang for MB-101 (IL13Ra2-targeted CAR T-cells) for the treatment of recurrent diffuse and anaplastic astrocytoma (astrocytomas) and glioblastoma (GBM).

The FDA grants Orphan Drug Designation to drugs and biologics that are intended for safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S. Orphan Drug Designation provides certain incentives, such as tax credits toward the cost of clinical trials upon approval and prescription drug user fee waivers. If a product receives Orphan Drug Status from the FDA, that product is entitled to seven years of market exclusivity for the disease in which it has Orphan Drug designation, which is independent from intellectual property protection.

Verastem Oncology , a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, recently announced that updated results from the Phase 1/2 FRAME study conducted by The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust were published online in Nature Medicine. The full manuscript, titled "Defactinib with avutometinib in patients with solid tumors: the phase 1 FRAME trial," was the first-in-human study to evaluate the safety, tolerability, and efficacy of avutometinib in combination with defactinib in patients with low-grade serous ovarian cancer (LGSOC), non-small cell lung cancer (NSCLC), and other solid tumor types.

"The FRAME study was the early foundation for the recent FDA approval of avutometinib plus defactinib in KRAS-mutated recurrent low-grade serous ovarian cancer and we are pleased to see that the mature data set continues to show the safety and tolerability of this combination therapy," said Dan Paterson, president and chief executive officer of Verastem Oncology. "This supports our ongoing commitment to advancing our research into the combination for use in other solid tumors, including RAMP 205 in first-line metastatic pancreatic cancer."

Cardiff Oncology, Inc. , a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, recently announced the company has appointed Roger Sidhu, MD, as Chief Medical Officer. Dr. Sidhu is a veteran executive and clinician with over 20 years of experience and a strong track record of success in oncology research, development, and regulatory strategy. Dr. Sidhu succeeds Dr. Fairooz Kabbinavar who will remain with the company in an advisory role. The company also announced it will share additional clinical data from its lead program in RAS-mutated mCRC on July 29, 2025.

“We are pleased to welcome Dr. Sidhu to lead the clinical program for onvansertib through the next phase of development. Dr. Sidhu is a respected clinician and seasoned executive with a proven track record of advancing innovative therapies through late-stage clinical development across multiple therapeutic areas including in first-line mCRC. As we move forward, we thank Dr. Kabbinavar for his leadership in progressing onvansertib’s clinical development across multiple tumor types,” said Mark Erlander, Chief Executive Officer of Cardiff Oncology. “In addition to today’s medical leadership transition, we are announcing our plan to share an update of clinical data from the ongoing CRDF-004 trial on July 29, at which point we expect to release a substantive dataset.”

AstraZeneca PLC 's Imfinzi (durvalumab) has been approved in the European Union (EU) for the treatment of adult patients with resectable muscle-invasive bladder cancer (MIBC) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as monotherapy adjuvant treatment after radical cystectomy (surgery to remove the bladder).

The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on results from the NIAGARA Phase III trial, which were published in The New England Journal of Medicine.

In a planned interim analysis, the Imfinzi-based perioperative regimen demonstrated a statistically significant 32% reduction in the risk of disease progression, recurrence, not undergoing surgery, or death versus neoadjuvant chemotherapy with radical cystectomy alone (based on event-free survival [EFS] hazard ratio [HR] of 0.68; 95% confidence interval [CI] 0.56-0.82; p<0.0001). Estimated median EFS was not yet reached for the Imfinzi arm versus 46.1 months for the comparator arm. An estimated 67.8% of patients treated with the regimen were event free at two years compared to 59.8% in the comparator arm.

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