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Biotech General Discussion

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BLU - Bull Thesis

BULL THESIS

  • BLU overall corporate and executive summary

    • ~$380M in cash (including $150M offering about to close)

      • Yrs of cash

      • Should cover thru Ph3 trial (need company confirmation)

    • Attractive <$1B MC/EV with lead (BLU-5937) entering Ph3 in large addressable market and impressive ph2 data

      • Single asset company - attractive acquisition target in future

      • 100% ownership of global rights to BLU-5937 + comp patents to 2034

    • Very good relative stock performance in 1H 2022 w contd. positive data on 5937

  • BLU-5937 potential best in class P2X3 antag for hi freq chronic cough

    • Large market (blockbuster potential)

    • Stock jumps - Sept ‘21 & Dec ‘21 on Ph2 hi freq cough data

    • Entering Ph3 in ‘22

    • Differentiated profile of much lower taste AEs with better efficacy than lead compound in class (MRK)

    • If MRK gets approved and succeeds in early market, could be positive for BLU because same cough measuring device and next-gen (differentiated) compound



FS/MV 7/16/22


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BULL THESIS (detailed)


  • BLU-5937 (2nd gen P2X3 antagonist)

    • Chronic cough (Phase 2b trial completed)

      • Should now have $ to get thru Ph3 trial

      • Expected multi-$B global market by 2027

      • Potential blockbuster drug for chronic cough in patients with high cough count

      • Potential to be best P2X3 antagonist in regards to class selectivity, efficacy, and tolerability (See table)

      • Initiating Ph3 trial in ‘22

      • Topline Phase 2b SOOTHE trial data reported in December 2021,

        • Reached primary efficacy endpoint with statistical significance (34% placebo-adjusted reduction in 24 hour cough frequency)

          • Patients w/ cough count at or above 25 coughs/hour

        • Well tolerated w/ low rate of taste related adverse events

        • Stock rose 33% when positive results reported

        • 50% of patients hit 50% cost reduction

        • Positive stat sig results in patient outcome measures

      • Low rate of taste-related adverse events across all dose levels (<6.5%)

        • Competitors show much higher occurrences of taste loss

          • Gefapixant - 58% in COUGH-1 and 69% in COUGH-2 Phase 3 trials had taste alteration and/or taste loss

          • Received CRL in Jan 2022; more info related to measurement of efficacy requested

          • Phase 2a trial showed limited benefit in low cough count (<30 coughs/hour)

          • Eliapixant - 13% taste AE in 75mg BID and 24% taste AE in 150mg BID

          • Recently discontinued (Feb 2022)

          • Sivopixant - 33% taste AE in safety analysis population

      • If MRK gets approved and succeeds in early market, could be positive for BLU because same cough measuring device and next-gen (differentiated) compound

    • Potential antagonist for additional cough and non-cough related indications

      • Neuropathic pain, overactive bladder, endometriosis pain

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