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Jun 30, 2021
CervoMed Q2 2021 Earnings Report
Diffusion Pharmaceuticals reported financial results for the second quarter of 2021 and provided a business update.
Key Takeaways
Diffusion Pharmaceuticals reported its Q2 2021 financial results, highlighting the completion and announcement of topline results from the COVID-19 Trial and the first Oxygenation Trial. The company's development plan remains on track and they anticipate cash runway through 2023, including completion of TSC Phase 2b Program.
Completed and announced topline results from COVID-19 Trial and the first Oxygenation Trial.
Observed improved outcomes in Phase 1b COVID-19 study with the 1.5 mg/kg dose of TSC.
Reported a positive trend in peripheral oxygenation in Phase 1b TCOM study.
Expects to announce initial indication and regulatory pathway in Q4 2021 and initiate clinical outcome study in the first half of 2022.
CervoMed
CervoMed
Forward Guidance
For the remainder of 2021, Diffusion is focused on the design and execution of the remaining two Oxygenation Trials to further their understanding of TSC’s mechanism of action and potential, as well as the further development of their regulatory and commercial strategy for TSC.
Positive Outlook
- Initiating and completing the Altitude Trial in the fourth quarter of 2021, with topline results available within one to two months of study completion.
- Initiating the ILD-DLCO Trial in the late fourth quarter of 2021 and completing the trial in the first quarter of 2022, with topline results available within one to two months of study completion.
- Announcing in the fourth quarter of 2021 the initial indication in which TSC will be studied to support the planned pathway for regulatory approval.
- Initiating a controlled, clinical outcome study evaluating TSC in the chosen indication during the first half of 2022, funded with cash-on-hand.
- TSC was safe and well-tolerated at all doses tested.