•Non-Dilutive Financing
• Up to US$10 Million Promissory Note Provided by Vantive
• If Fully Drawn, Promissory Note is Expected to Fully Fund Spectral to PMX Commercialization
•Company to host Corporate Update Call on May 15, 2025
TORONTO, May 07, 2025 (GLOBE NEWSWIRE) -- Spectral Medical Inc. ("Spectral" or the "Company") (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today announced that it has entered into a senior secured promissory note (the "Agreement") with Vantive US Healthcare LLC ("Vantive"), in the aggregate principal amount of up to US$10 million.
Under the terms of the Agreement, Vantive may advance funds to Spectral in up to four separate tranches to support Spectral's continued evidence generation strategy and path to commercialization of Toraymyxin ("PMX"). PMX is a blood filtration therapy that removes endotoxin, associated with sepsis, from the bloodstream.
The first tranche of US$4 million payable to Spectral was triggered on May 6, 2025 upon the execution of the Agreement. The milestones for the further three tranches are outlined in the Agreement as filed on SEDAR+.
The primary terms of the Promissory Note are:
- 4-year maturity
- Payment-in-Kind ("PIK") interest at an annual rate of 9%
- Principal balance and PIK interest to be repaid at maturity
- The Promissory Note is not convertible into any securities of the Company
Spectral does not anticipate requiring any additional funding to meet its upcoming key milestones, including release of topline results, U.S. FDA submission, and through to PMX commercialization.
"We are grateful to have such a committed partner in Vantive as we continue to advance PMX through the regulatory phase and, if ultimately approved, into commercialization," said Chris Seto, CEO of Spectral. "Not only does this promissory note provide us with non-dilutive funding on Company-friendly terms, it also highlights the strength, confidence and alignment between Spectral and Vantive."
Paradigm Capital Inc. acted as financial advisor to Spectral in connection with this transaction.
A copy of the Agreement will be filed under Spectral's profile on SEDAR+ at www.sedarplus.ca.
Spectral Medical Tigris Trial and Corporate Update Call
Chris Seto, Chief Executive Officer, and Dr. John Kellum, Chief Medical Officer, will host the call followed by a question-and-answer session. All interested parties are invited to participate.
CONFERENCE CALL DETAILS:
Date: Thursday May 15, 2025
Time: 11:00 a.m. ET
Dial-in: 1-877-407-0792 or 1-201-689-8263
Call meTM: https://callme.viavid.com/viavid/?callme=true&passcode=13744665&h=true&info=company&r=true&B=6
Participants can use Guest dial-in s above and be answered by an operator OR click the Call me link for instant telephone access to the event. *Available 15 minutes prior to scheduled start time.
Replay Dial-in: 1-844-512-2921 or 1-412-317-6671
Available May 15, 2025, 3:00 p.m. ET, until May 29, 2025, 11:59 p.m. ET
Conference ID: 13753414
About Spectral
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 FDA cleared Endotoxin Activity Assay (EAA), the clinically available test for endotoxin in blood.
PMX is approved for therapeutic use in Japan and Europe and has been used safely and effectively over 360,000 times 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.
The Tigris Trial is a confirmatory study of PMX in addition to standard care vs standard care alone and is designed as a 2:1 randomized trial of 150 patients using Bayesian statistics. Endotoxic septic shock is a malignant form of sepsis https://www.youtube.com/watch?v=6RANrHHi9L8.
The trial methods are detailed in "Bayesian methods: a potential path forward for sepsis trials".
Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information, please visit www.spectraldx.com.
Forward-looking statement
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 availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, 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.
The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this statement.
For further information, please contact:
| Ali Mahdavi | Chris Seto |
| Capital Markets & Investor Relations | CEO |
| Spinnaker Capital Markets Inc. | Spectral Medical Inc. |
| 416-962-3300 | |
| am@spinnakercmi.com | cseto@spectraldx.com |
