San Gabriel-based Vesicor Therapeutics, an early-stage biotech company focused on p53-based cancer therapeutics, has announced plans to go public through a merger with Black Hawk Acquisition Corp., a special purpose acquisition company (SPAC). The transaction values Vesicor at $70 million and is expected to be completed in the fourth quarter of 2025.
Founded in 2008 by Luo Feng, Ph.D., Vesicor specializes in developing cancer therapeutics delivered via precision-engineered microvesicles. Upon completion of the merger, Black Hawk will continue to be the listed company on the Nasdaq Stock Market but will change its name to Vesicor Therapeutics.
The Technology: p53-Based Cancer Therapeutics
Vesicor's lead product candidate, ecm-RV/p53, represents a novel approach to cancer treatment. The therapy consists of genetically engineered cellular microvesicles (ecm) containing non-viral nanoparticle RNA vesicles (RV) loaded with in vitro transcribed p53 mRNA.
The p53 gene, often called the "guardian of the genome," plays a crucial role in preventing cancer development by regulating cell division and triggering apoptosis (programmed cell death) in damaged cells. Mutations in the p53 gene are present in approximately 50% of human cancers, making it an attractive target for therapeutic intervention.
Clinical Experience in Japan
Although not yet approved in Japan or the United States, Vesicor's ecm-RV/p53 has been administered to multiple patients in Tokyo since 2018 under the Japan Medical Practitioner's Act, also known as Advanced Medical Care B. This regulatory mechanism allows physicians to use unapproved drugs at their discretion for patients with limited treatment options.
The company reports that its drug candidate has been used in patients with advanced breast, pancreatic, prostate, lung, and colorectal cancers. While detailed clinical outcomes have not been publicly disclosed, this early clinical experience provides valuable insights into the therapy's potential safety and efficacy profile.
Development Timeline and Strategic Plans
Vesicor intends to begin preclinical testing in the United States, submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration, and initiate clinical trials in 2026.
"Our mission is to transform the lives of cancer patients and their families. We are focused on completing preclinical testing in the United States, submitting our IND to the FDA and beginning Phase 1 clinical trials," stated Luo Feng, Ph.D., Founder and Chief Executive Officer of Vesicor Therapeutics.
Terms of the SPAC Merger
Under the terms of the Business Combination Agreement, Black Hawk's wholly-owned subsidiary, BH Merger Sub, Inc., will merge with Vesicor, resulting in Vesicor becoming a wholly owned subsidiary of Black Hawk. The transaction values Vesicor at a pre-money equity value of $70 million.
Existing Vesicor shareholders and management will not receive any cash proceeds as part of the transaction and will roll over 100% of their equity into the combined company. Shares held by certain Vesicor shareholders will be subject to lock-up agreements for a period of six months following the closing of the transaction, subject to certain exceptions.
Kent Kaufman, Chief Executive Officer of Black Hawk, expressed enthusiasm about the merger: "Our aim is to identify a company with solid potential to disrupt an entire industry, a talented and credentialed executive team with a proven track record, and good prospects for future growth. We believe that we have found these qualities in Vesicor."
Market Opportunity and Therapeutic Potential
Vesicor believes that its ecm-RV/p53 drug candidate has broad therapeutic potential across a range of solid tumors. The company's approach addresses a significant unmet need in oncology, particularly for cancers with p53 mutations that often respond poorly to conventional therapies.
The global market for targeted cancer therapies continues to expand rapidly, with novel delivery mechanisms and genetic approaches attracting significant investor interest. Vesicor's technology platform, if successfully developed, could potentially address multiple cancer indications with high mortality rates and limited treatment options.
Oded Levy, Board Director of Vesicor Therapeutics, commented on the strategic benefits of the transaction: "We are excited to partner with Kent and the rest of the Black Hawk team to bring Vesicor to the public markets. We believe that this transaction, if completed, will help facilitate access to the capital markets and will accelerate the validation and deployment of our ecm-RV/p53 drug candidate."
Regulatory Path Forward
The transaction is subject to regulatory approvals, shareholder approvals from both companies, and other customary closing conditions. These include the effectiveness of a Form S-4 registration statement filed with the U.S. Securities and Exchange Commission and approval by Nasdaq of the listing application for the combined company.
As Vesicor prepares to transition its technology from compassionate use in Japan to formal clinical trials in the United States, the company will face the rigorous regulatory requirements of the FDA's drug development process. The timeline for potential commercialization will depend on the outcomes of preclinical studies and subsequent clinical trials, which are expected to begin in 2026.
