CervoMed Q3 2021 Earnings Report
Key Takeaways
Diffusion Pharmaceuticals reported a third-quarter operating loss of $12.6 million, which included a non-cash asset impairment charge of $8.6 million. Excluding this charge, the operating loss decreased by $1.3 million. The company's cash and cash equivalents totaled $40.3 million as of September 30, 2021, and they anticipate that they have sufficient cash to fund operations and capital expenditures through 2023.
Altitude Trial is expected to commence in November 2021.
ILD-DLCO Trial is expected to commence in late December 2021.
The company plans to obtain input from the FDA on its design in early 2022 for the first clinical study in the hypoxic solid tumors program.
The Company recognized a non-recurring, non-cash asset impairment charge of $8.6 million during the third quarter of 2021 related to the full impairment of the in-process research and development asset associated with the Company’s DFN-529 product candidate.
CervoMed
CervoMed
Forward Guidance
Diffusion Pharmaceuticals anticipates sufficient cash to fund operations and capital expenditures through 2023 and is focusing on advancing its TSC development plans, including Oxygenation Trials and a clinical program for hypoxic solid tumors.
Positive Outlook
- Altitude Trial expected to commence in November 2021
- ILD-DLCO Trial expected to commence in late December 2021
- Plan to obtain input from the FDA on its design in early 2022 for the first clinical study in the hypoxic solid tumors program
- Data from the upcoming Altitude and ILD-DLCO Trials will be used to refine and enhance our understanding of TSC’s dose and effects that conceivably translate into a multitude of oncology and non-oncology indications.
- Company estimates that it has sufficient cash to fund operations and capital expenditures through 2023.
Challenges Ahead
- Study start date will be dependent upon FDA feedback and the availability of clinical drug supply.
- The Company recognized a non-recurring, non-cash asset impairment charge of $8.6 million during the third quarter of 2021
- Uncertainties related to the Company’s ability to design, initiate, enroll, execute, and complete its planned studies evaluating TSC
- Uncertainties related to the likelihood and timing of regulatory approval of TSC
- The impact of supply chain and other supplier issues on the Company’s clinical development program and associated timelines.