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Sep 30, 2021
Centessa Q3 2021 Earnings Report
Announced third quarter 2021 financial results and provided a review of recent accomplishments and anticipated upcoming milestones.
Key Takeaways
Centessa Pharmaceuticals reported a net loss of $40.2 million for the quarter ended September 30, 2021. The company's cash and cash equivalents were $578.8 million as of September 30, 2021, and pro forma cash and cash equivalents were $653.4 million, inclusive of the net proceeds from the first tranche received under the Oberland Agreement on October 4, 2021.
Announced positive topline data from proof-of-concept study of SerpinPC in severe hemophilia A and B subjects not on prophylaxis, demonstrating 88% reduction in median Annualized Bleeding Rate (“ABR”) for all bleeds and 94% reduction in median ABR for spontaneous joint bleeds in highest dose tested.
Announced proof-of-mechanism data from first three PiMZ subjects dosed in Phase 1 Part B study evaluating ZF874 for the treatment of Alpha-1 Antitrypsin Deficiency (“AATD”).
Announced collaboration between Orexia Therapeutics and Schrödinger to discover novel orexin receptor agonists.
Successful entry into a $300 million financing facility with Oberland Capital to enable further scale-up of development activities and pursuit of strategic business development opportunities.
Centessa
Centessa
Forward Guidance
Centessa Pharmaceuticals anticipates several milestones across its portfolio, including updates on SerpinPC, lixivaptan, ZF874, imgatuzumab, CBS001, CBS004, oral orexin receptor agonist, STAT3/5 program, and EGFR mutation inhibitors.
Positive Outlook
- ApcinteX’s SerpinPC: Expects to launch a global full development plan aimed at one or more registrations to maximize the broad potential for SerpinPC in the hemophilia space during 2022.
- Palladio Biosciences’ lixivaptan: Expects to dose the first subject in the registrational Phase 3 ACTION Study by 1Q 2022.
- Z Factor’s ZF874: Anticipates starting a global Phase 2 study in 2Q 2022, with 6-month dosing to commence in 2H 2022 once a dose and regimen are established and chronic animal toxicology is completed.
- Pega-One’s imgatuzumab: Expects to initiate an open-label, single arm, Phase 2 trial of imgatuzumab in advanced CSCC by the end of 2021 and dose the first subject in 1Q 2022.
- Capella Bioscience’s CBS001: In 1H 2022, the Company expects to submit a Clinical Trial Authorisation (“CTA”) application with the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) for CBS001 and commence a Phase 1 study shortly thereafter.
Challenges Ahead
- Because one subject showed a delayed, reversible increase in ALT and AST, the Company will be exploring lower doses and different dosing regimens for ZF874.
- The Company will not select a candidate for its exon20 mutation program in 2021 and is presently reviewing this program.
- Future results from ongoing and planned clinical trials are subject to risks and uncertainties.
- The company's ability to obtain adequate financing, including through its financing facility with Oberland, to fund planned clinical trials and other expenses, is subject to risks.
- The COVID-19 pandemic, including the effects of the Delta and any other variants, poses risks to the company's programs and operations.