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.
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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 th
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