Big news....deal valued at +4 billion plus around a billion in debt ..this could quickly get interesting.
seekingalpha.com
Baxter gains amid report in talks to sell kidney care spinoff to Carlyle for $4B
Baxter stock surges 5% on news of $4 billion deal with Carlyle Group for kidney care unit, potentially ending in sale instead of spinoff.
seekingalpha.com
News Press Releases
Spectral Medical Provides July Tigris Trial Update
T.EDT | 2 hours ago
• 125 patients enrolled
• Record July patient enrollment to start the second half of 2024
TORONTO, Aug. 01, 2024 (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 provided an update on the Company’s Tigris trial, a Phase 3 follow-on study evaluating the use of Polymyxin B Hemoperfusion (“PMX”) in a randomized controlled trial of adults treated for endotoxemia and septic shock.
Enrollment:
Robust enrollment to start the second half of 2024, which continues the pace experienced since January 2024:
125 patients enrolled at end of July 2024
Record monthly enrollment with nine patients enrolled in July – equals monthly enrollment record set in June
44 patients enrolled in 2024 so far – represents the most robust enrollment rates since the start of the Tigris study
With 25 patients to full enrollment, the Company has entered the final push to fully enroll and finish the Tigris trial
Based on current rate of enrollment, Tigris could be completed as early as December 2024
Trial Sites:
Currently 23 clinical sites
Spectral clinical team focused on trial site management activities to ensure that Tigris sites have the support and resources to enroll patients as efficiently as possible
Dr. John Kellum, Chief Medical Officer of Spectral, noted, “Tigris is gathering momentum as we enter the final months of the trial. We have a very strong group of sites and very dedicated investigators. We could not ask for a better team.”
Spectral Medical Provides July Tigris Trial Update
T.EDT | 2 hours ago
• 125 patients enrolled
• Record July patient enrollment to start the second half of 2024
TORONTO, Aug. 01, 2024 (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 provided an update on the Company’s Tigris trial, a Phase 3 follow-on study evaluating the use of Polymyxin B Hemoperfusion (“PMX”) in a randomized controlled trial of adults treated for endotoxemia and septic shock.
Enrollment:
Robust enrollment to start the second half of 2024, which continues the pace experienced since January 2024:
125 patients enrolled at end of July 2024
Record monthly enrollment with nine patients enrolled in July – equals monthly enrollment record set in June
44 patients enrolled in 2024 so far – represents the most robust enrollment rates since the start of the Tigris study
With 25 patients to full enrollment, the Company has entered the final push to fully enroll and finish the Tigris trial
Based on current rate of enrollment, Tigris could be completed as early as December 2024
Trial Sites:
Currently 23 clinical sites
Spectral clinical team focused on trial site management activities to ensure that Tigris sites have the support and resources to enroll patients as efficiently as possible
Dr. John Kellum, Chief Medical Officer of Spectral, noted, “Tigris is gathering momentum as we enter the final months of the trial. We have a very strong group of sites and very dedicated investigators. We could not ask for a better team.”
Looking very good heading into fall..up 20% in the last 10 days.
Spectral Medical Announces Second Quarter Results and Provides Corporate Update
T.EDT | 2 hours ago
Tigris Trial Enrollment Reaches 126 Patients
Strengthened Balance Sheet with Expected Funds to Complete Tigris Trial Enrollment
TORONTO, Aug. 09, 2024 (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 its financial results for the second quarter ended June 30, 2024, and provided a corporate update.
Spectral has continued its significant progress throughout the second quarter of 2024 both clinically and operationally and year-to-date enrolled 45 patients for a total of 126 patients out of the 150 total patients target. The Company is focused on the final push to fully enroll and finish the Tigris trial and believes that the continued onboarding of new Tigris sites since the fourth quarter of 2023 could further accelerate enrollment and allow Spectral to rapidly reach the 150-patients target, bringing the Company closer to FDA submission and potential FDA approval. In parallel to its clinical trial, the Company continues to work closely with its commercialization partner, Baxter.
Dr. John Kellum, Chief Medical Officer of Spectral Medical, stated, “We continue to witness robust enrollment activity in 2024, with record enrollment rates since the beginning of the year. Tigris is gathering momentum as we enter the final months of the trial. We have a very strong group of sites and very dedicated investigators, and the excitement level has never been higher. Our clinical team is focused on trial site support with activities to ensure that our Tigris sites have the support and resources to enroll patients as efficiently as possible. We are committed alongside our trial sites to advancing Tigris and believe PMX, if ultimately approved, will play a major role in reducing the tragic rates of mortality caused by sepsis.”
“I am pleased with the increased level of activity across the Company and the resultant ramp up of patient enrollment. The potential to sustain our current pace of enrollment could see us rapidly advance the trial towards completion in the late 2024 timeframe,” said Chris Seto, Chief Executive Officer of Spectral. “Additionally, with the receipt of gross proceeds of approximately $11 million since the beginning of April, we have secured funding to finalize Tigris enrollment.”
Dr. John Kellum, Chief Medical Officer of Spectral Medical, stated, “We continue to witness robust enrollment activity in 2024, with record enrollment rates since the beginning of the year. Tigris is gathering momentum as we enter the final months of the trial. We have a very strong group of sites and very dedicated investigators, and the excitement level has never been higher. Our clinical team is focused on trial site support with activities to ensure that our Tigris sites have the support and resources to enroll patients as efficiently as possible. We are committed alongside our trial sites to advancing Tigris and believe PMX, if ultimately approved, will play a major role in reducing the tragic rates of mortality caused by sepsis.”
“I am pleased with the increased level of activity across the Company and the resultant ramp up of patient enrollment. The potential to sustain our current pace of enrollment could see us rapidly advance the trial towards completion in the late 2024 timeframe,” said Chris Seto, Chief Executive Officer of Spectral. “Additionally, with the receipt of gross proceeds of approximately $11 million since the beginning of April, we have secured funding to finalize Tigris enrollment.”
Corporate Highlights During & Subsequent to Second Quarter 2024
Tigris Trial and Regulatory Program
- Patient Enrollment
- Total of 126 patients randomized to date out of the 150 total patients to be enrolled in the Tigris trial.
- Accelerated enrollment experienced in the second quarter and 2024 to date, with 45 patients enrolled so far – represents the most robust enrollment rates since the start of the Tigris trial.
- Record monthly enrollment with nine patients enrolled in June, followed equally with nine patients enrolled in July.
- Tigris Sites
Currently 23 Tigris sites onboarded, with the onboarding of the Thomas Jefferson University, which is an experienced, high-quality site from the EUPHRATES trial.- Spectral clinical team focused on trial site management activities to ensure that Tigris sites have the support and resources to enroll patients as efficiently as possible.
- Timing
The Company continues to focus on finalizing the Tigris trial within the reasonably shortest timelines. Based on the current rate of enrollment, Tigris could be completed as early as December 2024.
- PMX Commercialization
- Baxter Partnership Activities
In anticipation of a positive Tigris trial outcome, the Company has been working closely with Baxter on post-approval marketing plans for PMX commercialization. This includes developing product branding, pricing and roll-out plans with numerous Baxter departments, including marketing, regulatory, clinical and reimbursement. Baxter has communicated its intention to undertake a broad marketing campaign on day one of FDA approval for PMX. - Prismax Sub-study
The Company is also working with Baxter on a sub-study to obtain FDA clearance for hemoperfusion for Baxter’s Prismax device. The Prismax, with its leading installed base in ICUs throughout the U.S., is anticipated to be the primary ICU device utilized for PMX treatments on commercial launch.
- Baxter Partnership Activities
- Funding
- Bought Deal Private Placement Convertible Notes
On May 30, 2024, Spectral received USD $6,232 in convertible notes payable (the “Notes”) upon the completion of its private placement. 6,232 Notes were issued and have a face value of USD$1,000 per Note, bearing interest of 9% and are due May 1, 2028 (the “maturity date”). Holders of the notes may convert all or any portion of the Notes into common shares of the Company in integral multiples of USD $1,000 principal amount at any time prior to the maturity date. The Notes are convertible into approximately 16,359,000 Common Shares representing a conversion price of approximately CAD$0.52 per share subject to certain anti-dilution and make whole fundamental change adjustments.- Exercise of Anti-Dilution Pre-emptive Rights
On July 19, 2024 the Company completed an additional non-brokered offering of US$1 million of 9% convertible notes of the Company (the “Notes”) at a price of US$1,000 per convertible note due on May 1, 2028 (the “Offering”). The Notes were sold to one of the Company’s largest shareholders pursuant to the exercise of their anti-dilution pre-emptive rights relating to the closing of the offering of the approximately CAD$8.5 million offering of Notes that was completed on May 30, 2024. - Share Warrant Exercise / Expired Warrants
Subsequent to the second quarter end 207,500 share warrants were exercised for gross proceeds of approximately $102,250. These warrants were issued in conjunction with the Company’s July 27, 2021 and November 2, 2022 unit offerings.- On July 29, 2024, 10,982,500 share warrants expired. These expired share warrants were issued in conjunction with the Company’s approximately $10 million unit offering which closed on July 27, 2021. As at the time of this MD&A, the Company has 7,775,464 share warrants outstanding.
- Stock Option Exercise
1,799,460 stock options were exercised in the second quarter for gross proceeds of approximately $606,000. Almost all of the stock options exercised were held by the board and management of the Company, including Spectral’s CEO (Mr. Chris Seto), Board Chairman (Dr. Paul Walker), Director (Mr. William Stevens) and now former Director (Mr. Anthony Bihl).
- Addition to Spectral Board of Directors
- On June 7, 2024, the Company announced that it had appointed Mr. Cristiano Franzi to its Board of Directors. Mr. Franzi is a seasoned global healthcare executive and board director with a 30-year track record at leading global Med-Tech companies. As Regional President for businesses of up to $4 billion in size at Solventum, Baxter, Medtronic, and Covidien, Mr. Franzi has proven his ability to deliver value by developing compelling visions, identifying new market opportunities, and articulating clear growth strategies while streamlining operations and implementing highly disciplined business models.
- Change of Auditors
- On July 11, 2024, the Company announced that MNP has been appointed as the auditors of the Company following the decision by PricewaterhouseCoopers LLP (“PWC”) to resign as the auditor of Spectral. The PWC resignation was not the result of any disagreement between the Company and PWC on any matter of accounting principles or practices, financial statement disclosure, or auditing scope or procedure.
- Exercise of Anti-Dilution Pre-emptive Rights
- Bought Deal Private Placement Convertible Notes
- Total of 126 patients randomized to date out of the 150 total patients to be enrolled in the Tigris trial.
Baxter Agreement with Carlyle group...
Baxter Announces Definitive Agreement to Divest Its Vantive Kidney Care Segment to Carlyle for $3.8 Billion
Baxter International Inc. (NYSE:BAX), a global medtech leader, and funds managed by global investment firm Carlyle (NASDAQ:CG) today announced that they have...
www.businesswire.com
This is no doubt in reference to the Spectral filter, witch should have add on studies for expanded use..
Buying Spectral out is the only way the (below) vision is achieved
Interview With Vantive Latin American North Manager
Interview With Carlos Escobar - Vantive General Manager for Mexico, Central America, Puerto Rico and the Caribbean
24 October 2024
"Our strategy is to shift from focusing solely on one organ—kidney care—to supporting multiple organs. While kidney care remains our core business, we are expanding into the acute care space, which addresses organ failure in ICU patients. This segment, known as the acute business, is growing rapidly, with increasing demand for solutions that support not just kidney function, but also the liver, lungs, and patients with sepsis. These treatments are delivered through specialized devices used in ICU settings, rather than in home care environments."
Buying Spectral out is the only way the (below) vision is achieved
Interview With Vantive Latin American North Manager
Interview With Carlos Escobar - Vantive General Manager for Mexico, Central America, Puerto Rico and the Caribbean
24 October 2024
"Our strategy is to shift from focusing solely on one organ—kidney care—to supporting multiple organs. While kidney care remains our core business, we are expanding into the acute care space, which addresses organ failure in ICU patients. This segment, known as the acute business, is growing rapidly, with increasing demand for solutions that support not just kidney function, but also the liver, lungs, and patients with sepsis. These treatments are delivered through specialized devices used in ICU settings, rather than in home care environments."
Strange wording here...might be worth the listen
Spectral on Linkedin Today
Join Chris Seto, CEO, and Dr. John Kellum, CMO, for an exclusive update on the Tigris Trial and corporate developments. The call will include a Q&A session—don’t miss this opportunity to participate!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: Monday, December 16, 2024
Time: 10:00 a.m. ET
Dial-in: 1-877-407-0792 or 1-201-689-8263
https://callme.viavid.com
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 December 16, 3:00 p.m. ET, until December 30, 11:59 p.m. ET
Conference ID: 13750410
az lot to explain here, if you've been following along this may confirm The Caryle Groups involvement and potential take out of Spectral....
register with the code or use the link below..I had to join the Alliance to download this info, it's free.
stock up 10% today on this news.
sepsis alliance register
register with the code or use the link below..I had to join the Alliance to download this info, it's free.
stock up 10% today on this news.
sepsis alliance register
Some very bullish points from a group who's been quite on the positive forward looking statements in the past.
2 to go till completion.
I bought more a week and a half ago even in the face of a potential corporate raise
T.EDT | 3 hours ago
Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information, please visit www.spectraldx.com.
2 to go till completion.
I bought more a week and a half ago even in the face of a potential corporate raise
T.EDT | 3 hours ago
154 patients enrolled
TORONTO, March 27, 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 its financial results for the fourth quarter and for the year ended December 31, 2024 and provided a corporate update.
The Company made significant progress throughout 2024, both clinically and operationally. Specifically, regarding its Tigris trial, a Phase III clinical trial evaluating PMX for endotoxic septic shock. The Company has successfully enrolled 154 patients to date and is focused on the final push to fully enroll and finish the Tigris trial. The Company believes that the continued onboarding of new Tigris sites since the fourth quarter of 2023 could further accelerate enrollment experienced to date and allow Spectral to rapidly reach the 150 evaluable patient target, bringing the Company closer to FDA submission and potential FDA approval. In parallel to its clinical trial, the Company continues to work closely with its commercialization partner, Vantive US Healthcare LLC (“Vantive”); and most recently the parties collaborated on completing the PrisMax sub-study in February 2025.
Dr. John Kellum, Chief Medical Officer of Spectral Medical, stated, “We are very much in the final stretch of enrollment into Tigris, and we look forward to finalizing enrollment in the next few weeks. We are committed to advancing Tigris and believe PMX, if ultimately approved, will play a major role in reducing the tragic rates of mortality caused by sepsis.”
Corporate Highlights During & Subsequent to the Fourth Quarter and Fiscal Year Ended December 31, 2024
Corporate Highlights During & Subsequent to the Fourth Quarter and Fiscal Year Ended December 31, 2024
Tigris:
The Company made significant progress throughout 2024, both clinically and operationally. Specifically, regarding its Tigris trial, a Phase III clinical trial evaluating PMX for endotoxic septic shock. The Company has successfully enrolled 154 patients to date and is focused on the final push to fully enroll and finish the Tigris trial. The Company believes that the continued onboarding of new Tigris sites since the fourth quarter of 2023 could further accelerate enrollment experienced to date and allow Spectral to rapidly reach the 150 evaluable patient target, bringing the Company closer to FDA submission and potential FDA approval. In parallel to its clinical trial, the Company continues to work closely with its commercialization partner, Vantive US Healthcare LLC (“Vantive”); and most recently the parties collaborated on completing the PrisMax sub-study in February 2025.
Dr. John Kellum, Chief Medical Officer of Spectral Medical, stated, “We are very much in the final stretch of enrollment into Tigris, and we look forward to finalizing enrollment in the next few weeks. We are committed to advancing Tigris and believe PMX, if ultimately approved, will play a major role in reducing the tragic rates of mortality caused by sepsis.”
Corporate Highlights During & Subsequent to the Fourth Quarter and Fiscal Year Ended December 31, 2024
Corporate Highlights During & Subsequent to the Fourth Quarter and Fiscal Year Ended December 31, 2024
Tigris:
- Total of 154 patients randomized to date in the Tigris trial.
- Despite enrollment headwinds experienced in the fourth quarter of 2024, due to the impact of Hurricane Helene on the medical supply chain, Tigris 2024 enrollment was incredibly robust
- 59 patients enrolled in 2024 vs. 31 patients enrolled in 2023
- Strong start to 2025 enrollment
- 14 patients enrolled 2025 year-to-date
- Despite enrollment headwinds experienced in the fourth quarter of 2024, due to the impact of Hurricane Helene on the medical supply chain, Tigris 2024 enrollment was incredibly robust
- Timing
- Closing in on the full enrollment of 150 evaluable patients:
- Estimate a further two to four patients (given the randomization scheme) to reach 150 evaluable patients
- Addresses the six patients randomized into the PMX arm who did not receive the treatment
- Enrollment of 100 patients in the PMX arm and 50 patients in the standard-of-care arm who received the assigned treatment is important for PMX regulatory review with respect to safety analysis and secondary analyses
- Based on current rate of enrollment, management believes full Tigris enrollment is impending – and should be completed in the next few weeks.
- Closing in on the full enrollment of 150 evaluable patients:
- EDEN Abstract Presentation
- On February 23, 2025, an abstract of the EDEN study was presented by Dr. Mark Tidswell at the 2025 Society of Critical Care Medicine Annual Congress (see abstract: Critical Care Medicine)
- The Company completed its EDEN study in Q4 2023 with 92 patients enrolled. The ancillary observational study collected data on patients with sepsis even if ineligible for Tigris, and captured much needed data on the full range of septic shock and its relation to organ failure and endotoxin activity.
- Based on the results of 84 evaluable patients, compared to other patients with septic shock, those with endotoxic septic shock (EAA ≥ 0.6 and SOFA >11) had significantly higher mortality (60% vs 14.1%, p < 0.001).
- These data will inform subsequent discussions with the FDA on labelling for PMX, as well as to provide the medical community and the Company a better picture of the addressable population in the U.S. for PMX.
- A manuscript describing the full results of the EDEN study is in preparation and will be submitted to a medical journal in the next few weeks.
PMX Commercialization:
- On January 31, 2025, Baxter International Inc. (“Baxter”) completed the sale of its Kidney Care business, including Vantive and its affiliated entities throughout the world, to funds affiliated with The Carlyle Group, pursuant to which Spectral Medical’s PMX distribution agreement was assigned to Vantive.
- Commercialization Activities
- In anticipation of a positive Tigris trial outcome, the Company has been working closely with Vantive on post-approval marketing plans for PMX commercialization.
- In February 2025, the Vantive PrisMax sub-study was completed
- Vantive intends to submit a 510(k) application and obtain clearance for its PrisMax System
- The PrisMax System, with its leading installed base in ICUs throughout the U.S., is anticipated to be the primary ICU device utilized for PMX treatments on commercial launch
“We are on the cusp of full Tigris enrollment, which marks a major clinical milestone for Spectral. Completion of the Tigris study represents a big step forward in the potential of bringing the PMX therapy to market, and we look forward to our continued partnership with Vantive, and the development of a robust commercialization strategy,” said Chris Seto, CEO of Spectral. “Spectral is now entering a heavily-focused regulatory phase for PMX. The Company will be providing a more comprehensive view on Spectral’s regulatory pathway in the coming weeks.”
Balance Sheet and Financing Update
The Company has been and continues to actively evaluate financing scenarios with a view to be fully funded to PMX commercialization. Management anticipates having a fulsome update on its funding solution in the coming weeks, which will be followed by a corporate update conference call shortly thereafter.
Financial Review
Revenue for the three-months ended December 31, 2024 was $645,000 compared to $365,000 for the same three-month period last year. Total revenue for the year ended December 31, 2024 was $2,286,000 compared to $1,598,000 for prior year, representing an increase of $688,000, or 43%. Increase in revenue was primarily driven by a new customer who increased order volumes in 2024.
For the quarter ended December 31, 2024, the Company reported operating expense (income) of $(2,513,000) compared to $6,813,000 for the same period in 2023. When excluding the impact of the $Nil (2023 - $193,000 loss) on investment in iDialco and $Nil (2023 - $600,000) impairment loss on investment as an associate, operating expenses (income) for the quarter ended December 31, 2024 were $(2,513,000) compared to $6,020,000 for the same period in the prior year. The decrease of $8,533,000 was due to decreased fair value adjustment on derivative liability.
For the year ended December 31, 2024, operating costs were $17,681,000 compared to $17,105,000 for the same period in 2023, an increase of $576,000. When excluding the impact of the $Nil (2023 - $398,000 loss) on investment in iDialco, and $Nil (2023 - $600,000) impairment loss on investment as an associate, operating expenses for the year ended December 31, 2024 was $17,681,000 compared to $16,107,000 for the same period in the prior year. The increase of $1,574,000 was due to primarily increased interest expenses on financing and increased foreign exchange loss.
Clinical development and regulatory program costs (as disclosed in Note 22 of the consolidated financial statements) were $3,973,000 for the year ended December 31, 2024 compared to $4,676,000 for the same period in the prior year. A significant portion of clinical trial and regulatory costs consists of consulting and professional fees paid to contract research organizations, clinical sites, and other clinical and regulatory consultants. The decrease in costs reflects decreased activity with respect to the initialization of clinical sites and no CRO onboarding fees which were experienced in 2023 as the trial is projected to be completed in first quarter of 2025. Cumulative trial and regulatory program costs total $54,829,000 as of December 31, 2024.
For the quarter ended December 31, 2024, the Company reported a Loss (profit) from continuing operations of $(3,158,000) compared to $6,448,000 for the corresponding period in 2023. When excluding the impact of the $Nil loss (2023 - $193,000 loss) on investment in iDialco and $Nil (2023 - $600,000) impairment loss on investment as an associate, operating loss (profit) from continuing operations for the quarter ended December 31, 2024 was $(3,158,000) compared to $5,655,000 for the same period in the prior year.
For the year ended December 31, 2024, the Company reported a Loss from continuing operations of $15,395,000 compared to $15,507,000 for the corresponding period in 2023. When excluding the impact of the $Nil (2023 - $398,000 loss) on investment in iDialco and $Nil (2023 - $600,000) impairment loss on investment as an associate, operating loss from continuing operations for the year ended December 31, 2024 was $15,395,000 compared to $14,509,000 for the same period in the prior year.
The Company concluded the year end 2024 with cash of $2,988,000 compared to $2,952,000 of cash on hand as of December 31, 2023.
The total number of common shares outstanding for the Company was 284,316,207 at December 31, 2024
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”.
Balance Sheet and Financing Update
The Company has been and continues to actively evaluate financing scenarios with a view to be fully funded to PMX commercialization. Management anticipates having a fulsome update on its funding solution in the coming weeks, which will be followed by a corporate update conference call shortly thereafter.
Financial Review
Revenue for the three-months ended December 31, 2024 was $645,000 compared to $365,000 for the same three-month period last year. Total revenue for the year ended December 31, 2024 was $2,286,000 compared to $1,598,000 for prior year, representing an increase of $688,000, or 43%. Increase in revenue was primarily driven by a new customer who increased order volumes in 2024.
For the quarter ended December 31, 2024, the Company reported operating expense (income) of $(2,513,000) compared to $6,813,000 for the same period in 2023. When excluding the impact of the $Nil (2023 - $193,000 loss) on investment in iDialco and $Nil (2023 - $600,000) impairment loss on investment as an associate, operating expenses (income) for the quarter ended December 31, 2024 were $(2,513,000) compared to $6,020,000 for the same period in the prior year. The decrease of $8,533,000 was due to decreased fair value adjustment on derivative liability.
For the year ended December 31, 2024, operating costs were $17,681,000 compared to $17,105,000 for the same period in 2023, an increase of $576,000. When excluding the impact of the $Nil (2023 - $398,000 loss) on investment in iDialco, and $Nil (2023 - $600,000) impairment loss on investment as an associate, operating expenses for the year ended December 31, 2024 was $17,681,000 compared to $16,107,000 for the same period in the prior year. The increase of $1,574,000 was due to primarily increased interest expenses on financing and increased foreign exchange loss.
Clinical development and regulatory program costs (as disclosed in Note 22 of the consolidated financial statements) were $3,973,000 for the year ended December 31, 2024 compared to $4,676,000 for the same period in the prior year. A significant portion of clinical trial and regulatory costs consists of consulting and professional fees paid to contract research organizations, clinical sites, and other clinical and regulatory consultants. The decrease in costs reflects decreased activity with respect to the initialization of clinical sites and no CRO onboarding fees which were experienced in 2023 as the trial is projected to be completed in first quarter of 2025. Cumulative trial and regulatory program costs total $54,829,000 as of December 31, 2024.
For the quarter ended December 31, 2024, the Company reported a Loss (profit) from continuing operations of $(3,158,000) compared to $6,448,000 for the corresponding period in 2023. When excluding the impact of the $Nil loss (2023 - $193,000 loss) on investment in iDialco and $Nil (2023 - $600,000) impairment loss on investment as an associate, operating loss (profit) from continuing operations for the quarter ended December 31, 2024 was $(3,158,000) compared to $5,655,000 for the same period in the prior year.
For the year ended December 31, 2024, the Company reported a Loss from continuing operations of $15,395,000 compared to $15,507,000 for the corresponding period in 2023. When excluding the impact of the $Nil (2023 - $398,000 loss) on investment in iDialco and $Nil (2023 - $600,000) impairment loss on investment as an associate, operating loss from continuing operations for the year ended December 31, 2024 was $15,395,000 compared to $14,509,000 for the same period in the prior year.
The Company concluded the year end 2024 with cash of $2,988,000 compared to $2,952,000 of cash on hand as of December 31, 2023.
The total number of common shares outstanding for the Company was 284,316,207 at December 31, 2024
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.
Sitting on 212K at a $0.44 avg. Feel decent about that but need a mega homerun to make up for the opportunity cost on large caps that have been 3-10 baggers over short periods recently (without remotely close to the same level of risk as this micro cap).
Sense is bear case should be $1B market cap, which is a 5x from here.
Not sure why Paradigm is so low in its projections. Their NPV only goes ten years out, which I think is a flaw (albeit cash flows that far out are highly discounted anyways), and I also have trouble bridging their cash flow vs EBITDA per latest investor deck.
Sense is bear case should be $1B market cap, which is a 5x from here.
Not sure why Paradigm is so low in its projections. Their NPV only goes ten years out, which I think is a flaw (albeit cash flows that far out are highly discounted anyways), and I also have trouble bridging their cash flow vs EBITDA per latest investor deck.
