CRTX - Bull Thesis

BULL THESIS SUMMARY

• CRTX overall corporate and executive summary

• In a seminal clinical trial, CRTX established proof of concept that Alzheimer’s (AD) progress can be slowed by inhibiting gingivitis-causing bacteria.

  • AD is a huge unmet commercial need

  • Latest approved AD drug, Aduhelm from Biogen, has been disappointing, leaving huge opportunity for CRTX

• Current valuation creates an opportunity for inventors to get into CRTX at a very low valuation with huge upside

• Despite clinical trial/safety issues with its 1st P gigivalis inhibitor, CRTX has a next generation inhibitor with near-term safety readout

• Ended 2021 with $126.7M cash/equiv source

  • CRTX is wisely reducing cash burn to manage cash thru 2024.

• 2nd gen P ging inhibitor could have better tolerability

  • Near-term readout

  • Could be effective in AD, Parkin’s and periodontal disease

(See below for full bull/bear analysis)

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BULL THESIS (more details)

Atuzaginstat (COR388)(Lysine gingipain inhibitor)(Alzheimer's disease, Neurological disorder)

• Updated Phase ⅔ Data presented at CTAD 2021 supports P. gingivalis as a driver of Alzheimer’s in easily identified patient population

  • “While not meeting statistical significance on its co-primary cognitive and functional endpoints in the overall cohort, the study data showed that treatment with atuzaginstat slowed decline compared to placebo on the majority of clinical endpoints in prespecified populations that were selected based on P. gingivalis infection markers.” source

  • “Pre-specified subgroups representing up to half of the participants based on P. gingivalis infection level showed approximately 50% slowing of cognitive decline” source

  • While the Ph2/3 data for all patients treated did not meet stat sig, several prespecified subgroups did,

    • Established a new MOA for treating AD and CRTX has more drug candidates aimed at this MOA

• Placed on clinical hold 1/26/22

  • FDA hold update and additional data expected March 15-20, 2022

• $120 per share at all time high August 2021. (~$5.32 on 2/15/22 - ~$6.07 3/15/22)

  • Very low entry point currently with huge potential upside, making it an ideal risk reward

• Updated 3/20/22 Biomarker data presented at AD/PD source

  • “Lysine gingipain inhibition by atuzaginstat resulted in a 30% to 50% slowing of cognitive decline in the participants with high P. gingivalis load.” source

  • New biomarker data (CSF and MRI) supports MOA
    

Atuzaginstat (COR588)(Lysine gingipain inhibitor)(Alzheimer's disease, Neurological disorder)

• COR588 is a second-generation small-molecule lysine-gingipain inhibitor differentiated from COR388 by its improved pharmacokinetic properties and anticipated once daily oral administration

• Expect to pursue diseases related to P. gingivalis infection, following promising data from first generation COR388 GAIN trial.

• Currently in phase 1 SAD/MAD trial, Multiple ascending dose data expected in the second quarter of 2022

  • 3/8/22: preliminary results indicate COR588 was well-tolerated across all four cohorts in the dose range from 25 mg to 200 mg with no serious adverse events and an11-to-12-hour half-life consistent with once daily dosing and a dose-proportional pharmacokinetic profile that achieved and exceeded the targeted exposure predicted for therapeutic efficacy. Source

Future directions

• CRTX is developing 588 for oral cancers

• CRTX is developing an oral P ging inhibitor for periodontal disease, which since not delivered systemically should overcome the safety issues of COR 388.

• CRTX is developing anti-Covid therapeutic using its expertise in protease inhibitors
  

JM/MV 4/14/22

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