Calidi Readies SPAC Merger

Calidi Biotherapeutics, Inc. will soon be getting a ticker on the NYSE.

The company is currently preparing for a merger with special purpose acquisition company First Light Acquisition Group (FLAG) and expects to be trading on the NYSE American sometime in July as “CLDI.”

Total gross proceeds from the transaction, before payment of transaction expenses, are expected to be up to $82 million assuming no redemptions, combining a possible incremental financing of up to $40 million and up to $42 million held in the First Light trust account. The anticipated pro forma enterprise valuation is expected to be approximately $335 million.

“We are excited to partner with FLAG which we believe will accelerate our ability to bring life-changing therapies to patients, pairing our first-in-class, allogeneic stem cell-based technology with strategic partnering opportunities, to advance our goal of revolutionizing cancer treatment,” said Calidi CEO and Chairman of the Board Allan Camaisa. “Furthermore, the merger will allow us to leverage FLAG’s comprehensive network in both the private and public sectors, capital markets and operational experience to address missions of U.S. national and global importance.

The Calidi-FLAG merger was first announced in January 2023 and followed the August 2022 termination of a previously announced merger with Edoc Acquisition Corp. Camaisa said Calidi terminated the Edoc merger before it was completed, because Edoc failed to satisfy all conditions to closing of the business combination prior to the agreed-upon deadline in the business combination agreement.

Camaisa is very confident in the merger with FLAG and praised its team, which includes notable advisor Gen. James Cartwright, who served as vice chair of the Joint Chiefs of Staff across two presidential administrations and previously worked with DARPA on efforts associated with DNA/RNA protocols in support of potential future medical treatments. Already, FLAG has helped push Calidi to more align with government efforts in funding cancer therapies “because there’s a lot of interest from the federal government to reduce cancer by 50%,” Camaisa said, adding that FLAG is helping submit proposals to various federal and state agencies.

Those efforts are already bearing fruit on the state level. In December, the California Institute for Regenerative Medicine (CIRM) awarded Calidi a $3.1 million grant to support continued development of the company’s Supernova-1 (SNV1) pre-clinical program through an Investigational New Drug (IND) application. In addition, CIRM has awarded City of Hope a $12 million grant to fund a Phase 1 physician-sponsored clinical trial evaluating Calidi’s licensed oncolytic virotherapy NeuroNova platform in patients with recurrent high-grade glioma, a form of advanced brain cancer.

Clinical Development

Calidi’s therapies in clinical development – NeuroNova and SuperNova – use oncolytic viruses protected by stem cells to attack cancer tumors. Because the body does not recognize cancer cells as a threat, the virus is used to kill the tumor as well as stimulate the immune system to attack the tumor and even fight metastasized cancer cells. Camaisa described the stem cells as acting like a “Trojan horse” to hide the virus from the body’s immune system.

Calidi, in partnership with City of Hope, has dosed the first patient with NeuroNova and already has FDA clearance to start a larger clinical trial, once initial results are published.

Next year, Calidi plans to begin a Phase 1 study of its “flagship product” SuperNova in the United States or Australia to take advantage of that country’s generous rebate program, Camaisa said.

Cost saving is a founding principle behind Calidi’s therapeutic approach, which is “revolutionary,” Camaisa said, because it is a universal delivery system and not a personalized delivery system like a CAR-T therapy which can run up to $500,000 per patient.

“Our goal is to get the price point down,” Camaisa said. “Cancer therapy is very expensive. Only the wealthy and the ones with great insurance programs have access to cutting-edge clinical trials and then when you have approved drugs, if you do not have the right insurance program with a big company, you don’t have access.”

FLAG CEO Tom Vecchiolla cited Calidi’s “differentiated technology” and its potential to improve “quality of care, extend survival, and lower cost of treatment” as a key reason for its interest in merging with the company.

“Our goal is to invest in people and technologies that address the most important priorities and to deliver results with national and global effect,” he said. “We believe that Calidi’s innovative technology offers a differentiated immuno-oncology solution with a proprietary allogeneic stem cell-based universal delivery system that harnesses the potential of oncolytic viruses to address therapeutic needs in hard-to-treat cancers.”

Calidi Biotherapeutics, Inc.

Founded: 2014
CEO: Allan Camaisa
Business: Stem cell-based oncolytic virus delivery platform
Employees: 40
Headquarters: La Jolla
Website: www.calidibio.com
Notable: Calidi’s master stem cell bank was derived using liposuction of adipose-derived mesenchymal stem cells (lower back fat) from healthy adults.