Tigris patient enrollment momentum continues reaching 72
The Company anticipates three additional trial sites to be activated in Q3
NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES
TORONTO, Canada – September 7, 2023 – Spectral Medical Inc. (TSX: EDT) (the “Company” or “Spectral“), is pleased to announce that it has closed its previously announced ”bought deal” private placement of 9.0% convertible unsecured senior notes due November 1, 2026 (the “Notes”) of the Company at a price of US$1,000 per Note (the “Issue Price”) for aggregate gross proceeds of US$4,553,000 (the “Offering”). The Offering was conducted by Paradigm Capital Inc. (the “Underwriter”) and consisted of the sale of 4,553 Notes at a price of US$1,000 per Note.
The Notes have a face value of US$1,000 per Note, bear interest of 9% and are due on November 1, 2026 (the “Maturity Date”). Holders of the Notes may convert all or any portion of the Notes into common shares of the Company (the “Common Shares”) in integral multiples of US$1,000 principal amount at any time prior to the Maturity Date. The Notes are convertible into approximately 15,475,647 Common Shares, subject to customary anti-dilution and make whole fundamental change adjustments. Pursuant to the Note Offering, Baxter International Inc. (NYSE:BAX) (“Baxter”) agreed to purchase certain of the Notes in connection with an amendment to a portion of the last milestone payment due to the Company under the Distribution Agreement (as defined below). In 2020, Baxter, a leading global medical products company, entered into a distribution agreement (the “Distribution Agreement”) with the Company for PMX (as defined below) and the Endotoxin Activity AssayTM (EAA), an on-market companion diagnostic tool that aids in the risk assessment of ICU patients for progression to severe sepsis.
In connection with the Offering, the Underwriter received a cash commission of US$273,180 and 928,539 compensation options (the “Compensation Options”), with each Compensation Option entitling the holder thereof to acquire one Common Share at an exercise price equal to CDN$0.40 until the date that is three (3) years following today’s date.
The Company intends to use the net proceeds from the Offering for its Phase III registration trial (Tigris Study) for its PMX Product treatment for endotoxic septic shock and for general corporate and working capital purposes.
Chris Seto, Chief Executive Officer of Spectral Medical, stated, “We remain encouraged by the continued momentum and pace of patient enrollment in the Tigris study. We are now at 72 patients enrolled, and the study remains on track to reach the important interim milestone of 90 patients enrolled by the end of 2023. I would like to thank our strategic investors, Baxter and Pinnacle Island LP. Our investment partners understand and are aligned with the Company’s strategy, and I am pleased with their continued funding support to advance our pivotal Tigris trial.”
This press release does not constitute an offer to sell or a solicitation of an offer to buy the Notes in any jurisdiction, nor will there be any offer or sale of the Notes in any jurisdiction in which such offer, solicitation or sale would be unlawful. The Notes have not and will not be registered under the U.S. Securities Act or any U.S. state securities laws, and therefore will not be offered or sold within the United States except pursuant to applicable exemptions from the registration requirements of the U.S. Securities Act and applicable state securities laws.
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 endotoxic 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.
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:
Spectral Medical Inc.
Capital Markets & Investor Relations
Spinnaker Capital Markets Inc.