Diakonos Oncology Closes $20 Million Financing to Accelerate Phase 2 Glioblastoma Clinical Development Program and Expand Use of Innovative Dendritic Cell Platform for Studies in Other Indications

Recent Clinical Data for Dubodencel (DOC1021) in Glioblastoma Drive Financing with Backing from Baylor College of Medicine and The Brain Tumor Investment Fund

HOUSTON, May 30, 2025 /PRNewswire/ -- Diakonos Oncology Corp., a clinical-stage biotechnology company developing a new generation of immunotherapies to treat challenging and aggressive cancers, today announced the closing of a $20 million private placement of Simple Agreements for Future Equity (SAFE) to accelerate the company's Phase 2 glioblastoma trial for dubodencel, also known as DOC1021, and support the expansion of its clinical portfolio to other indications, including refractory melanoma. The financing includes backing by new investors Baylor College of Medicine (BCM), the Brain Tumor Investment Fund (BTIF), and the Buttonwood Titan QC Fund, with additional participation from existing shareholders including CEO Mike Wicks, MS. BCM is also contributing in-kind services toward the company's pre-clinical and clinical development programs. This $20 million financing follows Diakonos' oversubscribed $11.4 million seed financing that closed last year and serves as a bridge to a Series A financing that the company plans to launch in the second half of this year.

"With our Phase 2 glioblastoma trial underway at leading treatment centers across the U.S., the financing comes at a critical inflection point as we begin defining the path toward commercialization," said Jay Hartenbach, President and Chief Operating Officer of Diakonos Oncology. "Early clinical results in both glioblastoma and pancreatic cancer continue to exceed expectations, and when viewed alongside our data from a range of preclinical models, we are increasingly optimistic that this patient-derived immunotherapy holds potential for additional indications with high unmet need."

John Higgins, Managing Director at the Brain Tumor Investment Fund, added, "The promising Phase 1 data for dubodencel in glioblastoma were a strong motivator for us to help fund the Phase 2 trial, and we are pleased that our investment will serve as a catalyst for additional fundraising as the company advances the glioblastoma program and expands its clinical pipeline."

Joseph Petrosino, Ph.D., Chief Scientific Innovation Officer of Baylor College of Medicine, said, "At BCM, we are eager to propel our latest discoveries to the bedside, particularly for new therapies targeting glioblastoma and pancreatic cancer, where patients are in desperate need for better options. We are proud to work with Diakonos to accelerate these exciting early clinical results, and we are eager to support Diakonos as it builds on encouraging pre-clinical data suggesting dubodencel may be more broadly successful for the treatment of other difficult cancers and diseases."

Joseph Gunnar & Co. LLC served as placement agent for Diakonos in the SAFE offering. A SAFE is a non-debt instrument where an investor provides funding and receives the right to convert the investment into equity shares at a later date upon the occurrence of specified events, typically when a company raises a qualified equity financing round or experiences a liquidity event.

About Dubodencel

Dubodencel, also known as DOC1021, is a first-in-class, double-loaded autologous dendritic cell therapy that uniquely combines tumor lysate and amplified tumor-derived mRNA. The immunotherapy is made with a patient's dendritic cells combined with mRNA and proteins prepared from freshly obtained patient tumor specimens.

The unique double loading approach, which mimics a viral infection, unlocks a synergistic and exponentially more powerful tumor killing T_H1 response driven by dual protein and RNA antigen sourcing, and it allows targeting of the complete cancer antigen pool. Moreover, the approach does not require any molecular modification of the patient's immune cells for manufacturing, and it does not require preconditioning of bone marrow or high dose IL-2 for administration. Dubodencel allows for a simple administration in the outpatient setting and broad reach via community cancer centers.

In addition to the recently opened Phase 2 glioblastoma study, a clinical trial of Diakonos' dubodencel is ongoing for the treatment of pancreatic cancer. Diakonos received Fast Track designations from the FDA for both the glioblastoma and pancreatic cancer programs in October 2023 and May 2024, respectively. The company received Orphan Drug Designation for the glioblastoma program in January 2024.

About Diakonos Oncology Corp.

Based in Houston, Diakonos Oncology Corp. is a clinical-stage biotechnology company dedicated to revolutionizing cancer immunotherapy with its proprietary double-loaded, patient-derived dendritic cell therapeutic platform focused on addressing the critical, unmet medical need for treatment of late-state and aggressive cancers. For more information visit: https://www.diakonosoncology.com

About Baylor College of Medicine

Baylor College of Medicine in Houston is recognized as a health sciences university and is known for excellence in education, research and patient care. Baylor is a top-ranked medical school and listed 20^th among all U.S. medical schools for National Institutes of Health funding and No. 1 in Texas. Located in the Texas Medical Center, Baylor has affiliations with seven teaching hospitals and jointly owns and operates Baylor St. Luke's Medical Center, part of St. Luke's Health. Currently, Baylor has more than 3,000 trainees in medical, graduate, nurse anesthesia, physician assistant, orthotics and genetic counseling as well as residents and postdoctoral fellows. For more information visit: https://www.bcm.edu/ 

About The Brain Tumor Investment Fund

The Brain Tumor Investment Fund is a growing and diverse venture philanthropy fund that leverages the National Brain Tumor Society's (NBTS) 30 years of experience, expertise, and achievement. The fund will support NBTS's vision to conquer and cure brain tumors by investing in biotechnology, pharmaceutical, and medical device companies developing products to improve the lives of brain tumor patients.

The Brain Tumor Investment Fund sparks private sector investment in brain tumor research and to create a robust and diverse market for drug development, while increasing the likelihood of success for companies bringing life-changing products to market. For more information visit: https://braintumorinvestmentfund.org/

SOURCE Diakonos Oncology