Calidi Biotherapeutics has signed a forward purchase agreement with a consortium including Meteora Capital, Great Point Capital and Funicular Funds for up to $10 million.
Calidi Biotherapeutics has become the latest biotech to take the special purpose acquisition company route to the public market, loading up with almost $70 million in funds to develop its allogeneic stem cell therapies through to 2025.
The San Diego-based drug developer will debut on the Nasdaq this morning following a merger with SPAC First Light Acquisition Group yesterday. The combined company will continue to operate under the Calidi name and leadership team but now has about $28 million in gross proceeds as a result of the merger. However, around $18 million will be used to pay off transaction expenses and debts.
To top up funds, the biotech has also signed a forward purchase agreement with a consortium including Meteora Capital, Great Point Capital and Funicular Funds for up to $10 million, with plans to enter into a separate agreement with Lincoln Park Capital Fund for up to $50 million, according to the Sept. 13 release.
“Both of these opportunities have the potential to add cash to the balance sheet in the future,” Calidi said in the release. “The company believes that the proceeds available to the company from the transactions will be sufficient to fund its operations into 2025.”
Calidi’s sole clinical-stage asset is CLD-101, which uses its NeuroNova platform. This therapy consists of allogeneic neural stem cells loaded with an oncolytic adenovirus and has already completed a phase 1 study in patients with newly diagnosed high-grade gliomas. A separate early-stage study in high-grade gliomas got underway in June with an interim readout expected in the first half of 2024.
The biotech’s other highlighted candidate is CLD-201, which uses the SuperNova platform. This consists of allogeneic adipose-derived mesenchymal stem cells loaded with tumor-selective CAL1 oncolytic vaccinia virus. A phase 1/2 study assessing CLD-201 in advanced metastatic solid tumors including triple-negative breast cancer, unresectable melanoma and squamous cell head and neck carcinoma is anticipated to kick off in the second half of next year.
Founded in 2014, Calidi is focused on bringing “a universal cancer treatment to a broad patient population who need access to new treatment options,” CEO Allan Camaisa explained in this morning’s release.
While not as common as during their 2021 heyday, 2023 has seen a steady trickle of biotechs use the blank check route to go public. Notable examples of SPAC merger announcements this year have included Alzheimer’s-focused Anew Medical and gene therapy biotech enGene.
SAN DIEGO--(BUSINESS WIRE)--Calidi Biotherapeutics Inc., (approved for listing on NYSE American under “CLDI”), a clinical-stage biotechnology company that is developing a new generation of targeted immunotherapies, today announced that Allan Camaisa, CEO and Chairman of the Board, and Stephen Thesing, Chief Business Officer, will participate in a fireside chat at the upcoming Baird Global Healthcare Conference on Wednesday, September 13, 2023, at 7:55 a.m. ET.
About Calidi Biotherapeutics:
Calidi Biotherapeutics is a clinical-stage immuno-oncology company with proprietary technology designed to arm the immune system to fight cancer with a novel stem cell-based therapy delivering a payload to target and kill tumor cells. Calidi Biotherapeutics is advancing a potent allogeneic stem cell capable of carrying an anti-tumor payload for use in multiple oncology indications, including high-grade gliomas and solid tumors. Calidi’s off-the-shelf, universal cell-based delivery platforms are designed to protect, amplify, and potentiate oncolytic viruses leading to enhanced efficacy and improved patient safety. This dual approach can potentially treat, or even prevent, metastatic disease. Calidi Biotherapeutics is headquartered in San Diego, California. For more information, please visit .
This press release may contain forward-looking statements for purposes of the “safe harbor” provisions under the United States Private Securities Litigation Reform Act of 1995. Terms such as “anticipates,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predicts,” “project,” “should,” “would” as well as similar terms, are forward-looking in nature. The forward-looking statements contained in this discussion are based on Calidi’s current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Calidi will be those that it has anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Calidi’s control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: the final results of the clinical trials for CLD-101, insufficient funding to complete the clinical trials for CLD-101, the occurrence of a serious adverse event to a patient participating in the clinical trials for CLD-101, the occurrence of any event, change or other circumstances that could give rise to the termination of negotiations and any subsequent definitive agreements with respect to the proposed business combination transaction (the “Business Combination”) involving First Light Acquisition Group (“FLAG”) and Calidi; the outcome of any legal proceedings that may be instituted against FLAG, Calidi, the combined company or others following the announcement of the Business Combination, any private placement financing proposed to be consummated concurrently with the Business Combination (the “PIPE”), and any definitive agreements with respect thereto; the inability to complete the Business Combination due to the failure to obtain approval of the shareholders of FLAG, the inability to complete any PIPE or other financing needed to complete the Business Combination, or to satisfy other conditions to closing; changes to the proposed structure of the Business Combination that may be required or appropriate as a result of applicable laws or regulations or as a condition to obtaining regulatory approval of the Business Combination; the ability to meet stock exchange listing standards following the consummation of the Business Combination; the risk that the Business Combination disrupts current plans and operations of Calidi as a result of the announcement and consummation of the Business Combination; the ability to recognize the anticipated benefits of the Business Combination or to realize estimated pro forma results and underlying assumptions, including with respect to estimated shareholder redemptions; costs related to the Business Combination; changes in applicable laws or regulations; the evolution of the markets in which Calidi competes; the inability of Calidi to defend its intellectual property and satisfy regulatory requirements; the ability to implement business plans, forecasts, and other expectations after the completion of the proposed Business Combination, and identify and realize additional opportunities; the risk of downturns and a changing regulatory landscape in the highly competitive pharmaceutical industry; the impact of potential global conflicts (including the current conflict in Ukraine) may have on capital markets or on Calidi’s or FLAG’s business; the impact of the COVID-19 pandemic on Calidi’s business; and other risks and uncertainties set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in FLAG’s final prospectus dated September 9, 2021 and Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the SEC on March 31, 2023, and the risks and uncertainties indicated in the Registration Statement and the definitive proxy statement to be delivered to FLAG’s shareholders, including those set forth under “Risk Factors” therein, and other documents filed or to be filed with the SEC by FLAG.
Additional Information and Where to Find It
FLAG has filed with the SEC a registration statement on Form S-4 (as may be amended from time to time, the “Registration Statement”), which includes a preliminary proxy statement of FLAG, and a prospectus in connection with the proposed business combination transaction involving FLAG and Calidi. The definitive proxy statement and other relevant documents will be mailed to FLAG shareholders as of a record date to be established for voting on the Business Combination. FLAG securityholders and other interested persons are advised to read, when available, the preliminary proxy statement/prospectus, and amendments thereto, and the definitive proxy statement/prospectus in connection with FLAG’s solicitation of proxies for the special meetings to be held to approve the Business Combination because these documents will contain important information about FLAG, Calidi, and the Business Combination. Investors, securityholders and other interested persons will also be able to obtain copies of the Registration Statement, the proxy statement/prospectus and all other relevant documents filed or that will be filed with the SEC by FLAG, once such documents are free of charge, on the SEC’s website at or by directing a request to: First Light Acquisition Group, Inc., 11110 Sunset Hills Road #2278, Reston, VA 20190.
Participants in the Solicitation
FLAG and Calidi and their respective directors and officers and other members of management and employees may be deemed participants in the solicitation of proxies in connection with the proposed business combination. FLAG shareholders and other interested persons may obtain, without charge, more detailed information regarding directors and officers of FLAG in FLAG’s Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the SEC on March 31, 2023. Information regarding the persons who may, under SEC rules, be deemed participants in the solicitation of proxies from FLAG’s shareholders in connection with the proposed business combination will be included in the definitive proxy statement/prospectus that FLAG intends to the SEC.
No Offer or Solicitation
This communication does not constitute (i) a solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed Business Combination or (ii) an offer to sell, a solicitation of an offer to buy, or a recommendation to buy any security of Calidi, FLAG or any of their respective affiliates. There shall not be any sale of any securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the laws of such other jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, or an exemption therefrom.
Source: Calidi Biotherapeutics, Inc.
Welcome to this week's Chutes & Ladders, our roundup of hirings, firings and retirings throughout the industry. Please send the good word—or the bad—from your shop to Max Bayer or Gabrielle Masson, and we will feature it here at the end of each week.
Mirati CEO Meek steps down after Krazati’s hot and cold spell
A topsy-turvy year for Mirati Therapeutics has taken its latest turn, with CEO David Meek stepping down this week effective immediately. The move has forced outgoing president Charles Baum, M.D., Ph.D., to place his own departure plans on hold, taking the CEO reins on an interim basis. Meek will stay on as a consultant for the next two months.
No explanation was provided for Meek's departure, though fellow colleagues lauded him in a press release. Mirati Chairman Faheem Hasnain thanked Meek for his “significant impact” to growing the business and overseeing the development and FDA approval of Krazati and Baum said peers “extend our sincere gratitude to David.”
Mirati was the talk of the town earlier this year, fresh off accelerated approval of KRAS-targeting Krazati in December, setting up a showdown with Amgen’s Lumakras. The approval potential had spurred potential takeover interest at the tail end of the year. The company reported that the med raked in $13.4 million in revenue in the second quarter, above investor expectations.
But European regulators set the company back last month when they declined to greenlight the treatment, also known as adagrasib. The company has since said that they plan to formally ask the European Medicines Agency to reconsider. A little more than two weeks later, Meek's resignation was announced. Fierce Pharma
2 more Illumina execs depart amid sinking projections, SEC investigation
Illumina announced during its latest earnings presentation that two more execs are set to leave the company while simultaneously cutting the earnings forecast for this year. The testing giant now expects earnings from its business to roughly stay the same compared to 2022, growing about 1%. The company previously projected growth of 7% to 10%. A subsequent regulatory filing included a potentially even larger concern—Illumina says the US Security and Exchanges Commission reached out in July to let them know they were under investigation and that officials requested documents and communications related to the acquisition of GRAIL. Gulp!
Illumina will navigate these treacherous waters without Chief Medical Officer Phil Febbo, M.D., and Chief Technology Officer Alex Aravanis, M.D., Ph.D., who are both leaving the company.
Illumina made no mention of who will replace Febbo but announced Steven Barnard, Ph.D., will replace Aravanis. Barnard was previously VP and head of global advanced science and he’s been a fixture at the company since joining in 1998, notably the fourth employee and first scientist hired. While leading the global advanced science team, Barnard helped launch the NovaSeq X, a state-of-the-art unit that can perform whole genome sequencing, whole exome sequencing and whole transcriptome sequencing. Earnings presentation
Foghorn to switch up CMO in September after clinical holds stymie progress
Foghorn is making a switch at chief medical officer, with existing exec Sam Agresta, M.D., set to be replaced by Alfonso Quintás-Cardama, M.D., in September. Agresta will provide consulting services through the remainder of the year.
CEO Adrian Gottschalk thanked Agresta in a release for his contributions over his four-year tenure, during which the company launched its first clinical assets. Foghorn’s lead asset, FHD-286, is in a phase 1 trial though it dealt with a significant clinical hold that last 10 months. The company announced in June that it’d no longer advance the asset as a treatment for uveal melanoma and instead focus on launching a phase 1 combination study in patients with relapsed or refractory acute myeloid leukemia.
Getting that trial off the ground will likely be one of the top priorities for Quintás-Cardama when he takes over. But he’ll also have to work with the FDA to lift a second clinical hold on cancer med FHD-609, which had the clamps placed down in April. The company made no mention of the asset in its second-quarter earnings report earlier this month. Release
> Voyager Therapeutics is welcoming aboard Beth Shafer, Ph.D., to serve as chief business officer. Shafer joins the gene therapy biotech from Takeda, where she most recently held the role of VP and head of R&D business development, gastrointestinal and inflammation, neuroscience, drug discovery sciences, externalizations. Release
> Vivoryon Therapeutics Chief Medical Officer Frank Weber, M.D., is set to take the reins from CEO Ulrich Dauer, Ph.D., on Aug. 14. Weber joined Vivoryon in 2010 and will be supported by the company’s current head of investor relations, Anne Doering, who will step into the newly created position of chief strategy and investor relations officer. Release
> Viracta Therapeutics has tapped Darrel Cohen, M.D., Ph.D., to take on the role of chief medical officer. Before joining the oncology company, Cohen most recently served as CMO of cell therapy at Athenex and has past experience at Biosight Pharmaceuticals, EUSA Pharma, Pharmacia, Sanofi-Aventis and Pfizer. Release
> It’s the week of executive moves for biotechs that start with the letter “V,” and Vigil Neuroscience is no exception. The neurodegenerative-disease-focused company is welcoming Christopher Silber, M.D., on as chief medical officer. The leader joins from Nocion Therapeutics, where he also served as CMO, and before that served as Sage Therapeutics’ SVP of clinical development. Release
> Tango Therapeutics Chief Scientific Officer Alan Huang, Ph.D., is ending his dance with the cancer company in October. In his place steps Jannik Andersen, Ph.D., Tango’s current head of biology. Release
> Avalyn Pharma has appointed Howard Lazarus, M.D., to breathe life into its team in the newly formed role of chief medical officer. Lazarus most recently served as CMO for Altavant Sciences (acquired by Enzyvant), and earlier worked at Boehringer Ingelheim and Gilead Sciences. Release
> As Ankyra Therapeutics prepares to bring its first asset to the clinic, the cancer company is welcoming Robert Tighe on as chief scientific officer. He started off his career as a research assistant in the lab of Robert Weinberg, Ph.D., at the Massachusetts Institute of Technology, and has worked at EMD Serono, Compass Therapeutics and TCR2 Therapeutics since. Release
> Indaptus Therapeutics has tapped Roger Waltzman, M.D., to be the biotech’s chief medical officer. Waltzman joins from Molecular Templates, and has previously held leadership roles at Rgenix (now Inspirna), Jaguar Health and Novartis. Release
> Kytopen has signed on Michael Chiu, Ph.D., to succeed company co-founder Paulo Garcia, Ph.D., as the biotech’s CEO. Prior to Kytopen, Chiu was CEO of Erbi Biosystems, which was acquired by Merck KGaA last year. Release
> Processa Pharmaceuticals has picked George Ng to lead the company as CEO and director of the board. Ng is currently a partner at PENG Life Science Ventures joins Processa from Calidi Biotherapeutics, where he served as president and chief operating officer. Release
> England-based Dunad Therapeutics has selected Jonathan Garen to serve as chief business officer. Before Dunad, Garen was CBO for Nocion Therapeutics and uniQure. Release
> Platform company Auron Therapeutics has hired Christopher Guiffre to serve as president and chief operating officer. Guiffre joins from Pear Therapeutics, where he was chief financial officer and chief operating officer since 2017. Release
> Christophe Arbet-Engels, M.D., Ph.D., is set to join X4 Pharmaceuticals as chief medical officer. He previously held the CMO spot at several other biopharmas and also held a range of senior positions at Biogen, Boehringer Ingelheim Pharmaceuticals, Hoffmann-La Roche, Merck Research Laboratories, Aventis Pharmaceuticals and Ligand Pharmaceuticals. Release
> AI Proteins Chief Operating Officer Noah Beerman is taking the lead as CEO of the biotech. Former CEO Drew Dennison has stepped down but will continue to chair the nominating and governance committee and serve as a board director. Release
> Deciphera Pharmaceuticals founder, EVP and Chief Scientific Officer Daniel Flynn, Ph.D., is set to retire Sept. 5. Dashyant Dhanak, Ph.D., Incyte’s EVP and CSO, will take Flynn’s place. Release
100 项与 Calidi Biotherapeutics, Inc. (United States) 相关的药物交易