Paradigm updated their coverage to a buy.
You can email Paradigm for a copy.
Author : Scott McAuley, PhD, Analyst
expanded use numbers and new target price.
Going from 120,000 annual addressable patients with penetration of 35% (42,000 patients) to now using 280,000 patients at 20% penetration (56,000 patients)
You can email Paradigm for a copy.
Author : Scott McAuley, PhD, Analyst
expanded use numbers and new target price.
Going from 120,000 annual addressable patients with penetration of 35% (42,000 patients) to now using 280,000 patients at 20% penetration (56,000 patients)
Getting the standard of care from the FDA would be huge..this type of gut sepsis with high endotoxin stands as untreatable barring standard antibiotics witch have a poor success rate....
Hang tight...
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Been a little weary of posting anything directly from analysis reports..some are just for paying clients...
This is copied off another board in reference to the Paradigm report mentioned above.
"In fairness, Paradigm is trying to walk a fine line of having Spectral as a client, while also being in charge of finding investors to purchase our paper. I definitely think they were way too conservative with their estimates, but I also undertand their desire to appear somewhat unbiased just prior to a raise. They do acknowledge how conservative they were being, and they offer this paragraph as a sort of mea culpa."
New Analysis Highlights Upside to Market Assumptions
The company also presented Incidence of Endotoxic Septic Shock in the U.S. and Canada. Additional
analysis of the prior EUPHRATES Phase 3 trial led to an updated estimate that ~37.3% of all septic
shock patients in Canada and the U.S. have endotoxic septic shock (ESS), which is defined by endotoxin activity assay (EAA) level >0.6. Based on different estimates of septic shock incidence in the U.S., anywhere from 180,000380,000 patients per year have this ESS subset of septic shock. We have been using a total endotoxemic septic shock market opportunity of 120,000 per year in our assumptions. Therefore, these new estimates provide 50217% upside to our market estimates.
This is copied off another board in reference to the Paradigm report mentioned above.
"In fairness, Paradigm is trying to walk a fine line of having Spectral as a client, while also being in charge of finding investors to purchase our paper. I definitely think they were way too conservative with their estimates, but I also undertand their desire to appear somewhat unbiased just prior to a raise. They do acknowledge how conservative they were being, and they offer this paragraph as a sort of mea culpa."
New Analysis Highlights Upside to Market Assumptions
The company also presented Incidence of Endotoxic Septic Shock in the U.S. and Canada. Additional
analysis of the prior EUPHRATES Phase 3 trial led to an updated estimate that ~37.3% of all septic
shock patients in Canada and the U.S. have endotoxic septic shock (ESS), which is defined by endotoxin activity assay (EAA) level >0.6. Based on different estimates of septic shock incidence in the U.S., anywhere from 180,000380,000 patients per year have this ESS subset of septic shock. We have been using a total endotoxemic septic shock market opportunity of 120,000 per year in our assumptions. Therefore, these new estimates provide 50217% upside to our market estimates.
just looked at the report..as I said the above was copied from another site.
Not positive how he came up with the %
Verbatim from the report: below.
"Updating Market Assumptions | Recent analysis by EDT indicates that the market
opportunity is likely larger than our initial estimate. We have been using 120,000
patients as the annual addressable market opportunity, with peak sales penetration
at 35% (42,000 patients). Updated analysis of the Phase 3 EUPHRATES data
presented at the Society of Critical Care Medicine’s Annual Congress suggests that
the market for endotoxemic septic shock could be between 180,000 and 380,000
patients per year. We have updated our peak estimates to be 20% of 280,000,
resulting in 56,000 patients per year."
It may slip a bit in price....Next big inflection point is topline numbers, if those are good you'll see a major price increase. (early August) The call on the 15th of next month could be revealing and is open to investors, I suspect at that point they may disclose who's involved in the non dilutive financing . If it's CG? that will also be a price bump.
It's finally getting interesting here
Key Post-Tigris Enrollment Milestones
It's finally getting interesting here
Key Post-Tigris Enrollment Milestones
- Total enrolled patients:
- 157 total patients enrolled
- 151 evaluable patients, 100 treated with PMX
- 28-day follow-up for last patient enrolled to be completed on May 8, 2025
- 157 total patients enrolled
- Release of topline results:
- Data lock to be completed approximately 90 days after final patient 28-day follow-up
- Expected release of topline results approximately 2 weeks post-data lock
- PMA submission:
- The Company’s Premarket Approval submission (“PMA”) is a modular approach, whereby non-clinical aspects are submitted separately from the clinical data
- To-date the Company has submitted all non-clinical studies and reports to the US Food & Drug Administration (“FDA”) for evaluation
- On track to submit the clinical results and reports by end of October 2025
- Data lock to be completed approximately 90 days after final patient 28-day follow-up
- 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 me™: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
If it affirms a growing relationship with Vantive he's can "ummmmm"all he wants.
Any announcement would be more potent coming from the Vantive side as opposed to what is a little known company who's traded on the pink sheets....
Got the new analysis update..it's promising, teasing a + 15% benefit
