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Spectral Medical Inc T.EDT

Alternate Symbol(s):  EDTXF

Spectral Medical Inc. is a Canada-based late-stage theragnostic company advancing therapeutic options for sepsis and septic shock. The Company develops and commercializes a treatment for septic shock utilizing its Endotoxin Activity Assay (EAA) diagnostic and the Toraymyxin therapeutic (PMX). PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the Company’s EAA. 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. It has pioneered the development of biochemical markers for the clinical syndrome known as septic shock. It is continuing its legacy business of manufacturing and selling certain proprietary reagents. It develops, produces and markets recombinant proteins, antibodies and calibrators. These materials are sold for use in research and development, as well as in products manufactured by other diagnostic companies.


TSX:EDT - Post by User

Post by mercedesmanon Apr 27, 2023 1:57pm
317 Views
Post# 35417525

Feeling a bit guilty....

Feeling a bit guilty.......acquiring more in the mid to high 20's !

Especially given what insiders, Board members and the FA80 paid recently for their units (almost 20% discount after Black Scholes assignment of value of .06 to warrants).

And given:
  • Baxter ($ 25B Market Cap) signed a Distribution Agreement  with Spectral effectively giving them dibbs on PMX distribtuion in the US, complete with 3 payments to defray the costs of completing the Phase 3 Confirmatory Trial.
  • 2nd installment due after Interim Data release at patient 90 (roughly 35 to go) In addition to many millions towards trial costs, Baxter recently made a  quasi equity investment (convertable debt instrument)
  • Baxter recently announced a reorganization with KidneyCo. - a $ 5 Billion spinoff - which featured prominently the EAA and PMX products.
  • Revised estimates to Trial completion 18-24 months - factoring in new initiatives to speed up enrolment.
  • reiteration that Tigris results so far, continue to "exceed expectations"...which really means they are more than confirming the Euphrates subgroup.
  • Confirmatory Euphas 2 results (10 year long study on the Use of PMX to treat severe Sepsis patients in Europe).  Results similar to Tigris so far.
  • In 2022 Toraymyxin receives Breakthrough Device designation  (suggesting that the FDA is optimistic so far)
  • Recently John Kellum (KOL) announces his commitment to "see this through" to the end, as the culmination of his life's work in studying Sepsis, AKI and hemoperfusion.
  • Spectral's seemingly unlimited ability to raise cash when needed.  One more raise to go (given Baxter second and third installments)?
  • EBITDA analysis provided by Mgt. that suggests a major undervaluation by the market, or at the very least upon successful trial completion and approval by the FDA.
  • "addressable market" seems to be much larger than the EBITDA analysis assumes !
  • iDialco JV (side bet) needs to mature, but it is a "spun-off" investment that still has to be monetized.  Infomed to carry the majority of cash infusions from here, on the way to commercialization (less cash flow burn to SPectral in the next 1-2 years.
MM

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