NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN OR INTO THE UNITED STATES OF AMERICA OR TO ANY PERSON LOCATED OR RESIDENT IN THE UNITED STATES OF AMERICA, ITS TERRITORIES AND POSSESSIONS, ANY STATE OF THE UNITED STATES OR THE DISTRICT OF COLUMBIA.
TORONTO, Canada – August 22, 2023 – Spectral Medical Inc. (TSX: EDT) (the “Company” or “Spectral“), is pleased to announce that in connection with its previously announced bought deal private placement financing (the “Offering”), the Company and Paradigm Capital Inc. (the “Underwriter”), have agreed to increase the size of the Offering. The Company now intends to issue 9% convertible notes of the Company (the “Convertible Notes”) at a price of US$1,000 per Convertible Note for total gross proceeds of approximately C$5,500,000 (the “Amended Offering”).
In addition, the Company has granted the Underwriter an option to sell up to that number of additional Convertible Notes equal to 15% of the Amended Offering, which option shall be exercisable in whole or in part at any time, 48 hours prior to the Closing Date (as defined below).
The net proceeds from the Amended Offering are expected to be primarily used by the Company on its Phase III registration trial (Tigris) for its PMX treatment for endotoxemic septic shock and for general corporate and working capital purposes.
The Amended Offering is expected to close on or about August 30, 2023 (the “Closing Date”) and will be subject to regulatory approvals and customary closing conditions, including listing of the common shares issuable upon conversion of the Notes on the Toronto Stock Exchange.
The securities have not been, and will not be, registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”), or any U.S. state securities laws, and may not be offered or sold in the United States without registration under the U.S. Securities Act and all applicable state securities laws or compliance with the requirements of an applicable exemption therefrom. This press release does not constitute an offer to sell or the solicitation of an offer to buy securities in the United States, nor may there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.
Spectral is a Phase 3 company seeking U.S. FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin™ (“PMX”). PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the Company’s Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the risk of developing sepsis.
PMX is approved for therapeutic use in Japan and Europe, and has been used safely and effectively on more than 340,000 patients to date. In March 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for PMX, and in November 2010, signed an exclusive distribution agreement for this product in Canada. In July 2022, the U.S. FDA granted Breakthrough Device Designation for PMX for the treatment of endotoxemic septic shock. Approximately 330,000 patients are diagnosed with septic shock in North America each year.
Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information please visit www.spectraldx.com.
Information in this news release that is not current or historical factual information may constitute forward-looking information within the meaning of securities laws. Implicit in this information, particularly in respect of the future outlook of Spectral and anticipated events or results, are assumptions based on beliefs of Spectral’s senior management as well as information currently available to it. While these assumptions were considered reasonable by Spectral at the time of preparation, they may prove to be incorrect. Readers are cautioned that actual results are subject to a number of risks and uncertainties, including the company’s ability to raise capital and the availability of funds and resources to pursue R&D projects, the recruitment of additional clinical trial sites, the rate of patient enrollment, the successful and timely completion of clinical studies, the success of Baxter’s commercialization efforts, the ability of Spectral to take advantage of business opportunities in the biomedical industry, the granting of necessary approvals by regulatory authorities as well as general economic, market and business conditions, and could differ materially from what is currently expected.
Risks and other factors that could cause actual results or events to differ materially from current expectations with respect to the Amended Offering include, but are not limited to, the risk of unforeseen delays in the completion of the Amended Offering whether as a result of market conditions or otherwise, the failure of the Company to obtain the requisite regulatory approvals for the Amended Offering and the inability of the Company to satisfy all conditions to the completion of the Amended Offering (if at all). There can be no assurance that the Amended Offering will be completed. Actual results could differ materially from what is currently expected, and readers are cautioned not to place undue reliance on these forward-looking statements. Except as required by law, the Company disclaims any obligation to update or revise any forward-looking statements. Reference is also made to the other risks and uncertainties that may affect the Company which are more fully described in the Company’s Annual Information Form dated March 24, 2023, and other filings of Spectral with the securities regulatory authorities which are available at www.sedarplus.com.
The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this statement
For further information, please contact:
Capital Markets & Investor Relations
Spinnaker Capital Markets Inc.
Spectral Medical Inc.