Dermata Therapeutics, Inc. (DRMA) gained in the pre-market after submitting two-sec filings. DRMA values at $1.40, gaining more than 30% compared to yesterday’s closing price. The stock closed at $1.07 at the end of the last trading session. The stock volume traded in the last trading session was around 224.22K shares. The current market cap of the company is around $8.91 million.
The SEC Filings
Dermata Therapeutics, Inc. has asked the FDA to waive the 90-day dermal minipig study and standard dermal pharmacokinetic study requirements for its DMT310 acne program. DMT310 has been well-tolerated in over 170 human patients. It is a 180-person Phase 2 rosacea trial. After the 90-day dermal minipig study, human trials are usually required. The company could cite the FDA’s Botanical Drug Development Guidance for Industry, and the FDA approved DMT310 for human trials without the 90-day dermal minipig study. Waiver of 90-day dermal minipig study based on DMT310 human safety data and historical data hopes to save $600,000 if the FDA approves the 90-day dermal minipig waiver. That is why an NDA is required.
FDA also waived the dermal pharmacokinetic study. The company seeks DMT310 tolerance and safety waiver. It will start in late 2022 if the FDA grants both waiver requests. In 2022, the company could complete the standard dermal pharmacokinetics study and start the Phase 3 program. Phase 3 could delay until 2023 due to the 90-day dermal minipig study’s supply chain issues.
In another sec filing, the company announced its general statement of registration for all businesses, including those issuing face-amount certificates.
DRMA was down yesterday, but today, it is skyrocketing
They lost more than 20% at the end of the last trading session after announcing the sec filings. However, today, in the pre-market, it is skyrocketing and gained value of more than 30%. The company went public last year, and since then, it has been on the decline and losing its value.
Conclusion
Dermata Therapeutics, Inc. (DRMA) is looking forward to a significant breakthrough in the research that could become a revenue stream. The company is at the pre-revenue stage right now and is losing money.
