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Dec 31, 2020
CervoMed Q4 2020 Earnings Report
Reported financial results for 2020 and provided a business update.
Key Takeaways
Diffusion Pharmaceuticals reported its 2020 financial results, highlighting a transformational year with a strengthened management team, advancement of its TSC development, and enhanced financial stability through multiple offerings.
Strengthened management team with key appointments.
Advanced development of trans sodium crocetinate (TSC) with a Phase 1b trial in COVID-19 patients.
Initiated three oxygenation studies to explore the relationship between TSC exposure and oxygenation levels.
Enhanced financial stability with $18.5 million in cash and cash equivalents as of December 31, 2020, and additional proceeds received in Q1 2021.
CervoMed
CervoMed
Forward Guidance
The company intends to undertake a prospective exploration of the relationship between the level of TSC exposure (dose) and response (change in oxygenation) by conducting three short-term clinical trials in the United States during 2021.
Positive Outlook
- Evaluate the effects of TSC on peripheral tissue oxygenation using a transcutaneous oxygen monitoring (“TCOM”) device.
- Evaluate the effects of TSC on maximal oxygen consumption (VO2), and partial pressure of blood oxygen (PaO2), in normal healthy volunteers exposed to conditions that induce hypoxia.
- Evaluate the effects of TSC on the diffusion of carbon monoxide through the lungs (“DLCO”) in patients with previously diagnosed interstitial lung disease who have a baseline DLCO test result that is abnormal.
- Outcomes from one or each of these Oxygenation Trials will inform the company’s go-forward TSC clinical development path, focusing on the demonstration of clinical and therapeutic benefits of TSC in relevant patient populations across the hypoxia continuum.
- Assuming success in one or more of the three Oxygenation Trials, the Company expects to identify and announce the specific, hypoxia-related indication it will target, in the fourth quarter of 2021.
Challenges Ahead
- The Company’s ability to design, initiate, enroll, execute, and complete its ongoing and planned studies evaluating TSC
- General economic, political, business, industry, and market conditions, including the ongoing COVID-19 pandemic
- Risk factors in the Company’s filings most recent Annual Report on Form 10-K and other filings with the SEC
- Uncertainty of future events or outcomes
- The Company’s actual results could differ materially from those expressed or implied in any forward-looking statement