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Tag: Dermata Therapeutics

  • Pre-Market Momentum: Dermata Therapeutics (DRMA) Sees Sharp Gains

    Pre-Market Momentum: Dermata Therapeutics (DRMA) Sees Sharp Gains

    Dermata Therapeutics, Inc. (NASDAQ: DRMA) has seen a sharp gain in share price; the company is currently trading at $2.18, indicating a stunning 61.48% increase in pre-market activity. This spike comes after the company’s major Phase 3 clinical trial released encouraging early findings.

    Breakthrough Findings from the XYNGARI Trial

    The first Phase 3 study of Dermata Therapeutics’ once-weekly topical therapy XYNGARI, which treats moderate-to-severe acne, showed promising topline results. The findings indicated that XYNGARI had a good safety profile in addition to exhibiting excellent effectiveness. Patients responded favorably to the medication, with few adverse events and no significant side effects.

    After just 12 weeks of therapy, the Phase 3 Spongilla therapy for Acne Research (STAR-1) study demonstrated a statistically significant improvement when compared to a placebo, meeting all three of the main objectives. This result highlights XYNGARI’s potential as a successful acne therapy.

    Overcoming Obstacles in Patient Compliance

    The creation of XYNGARI represents a major breakthrough in acne therapy, especially considering that it is used once a week. The weekly schedule of XYNGARI may improve patient adherence in contrast to current FDA-approved topical acne therapies, which call for daily or twice-day administrations. By tackling patient compliance, a key obstacle to successful acne control, this invention may enhance overall treatment results.

    Strategies for Upcoming Research and Regulatory Submission

    Dermata Therapeutics is proceeding with planning for the Phase 3 STAR-2 study, which is scheduled to start in the second half of 2025, after receiving encouraging findings from the Phase 3 trial. A New Drug Application (NDA) filing to the U.S. Food and Drug Administration (FDA) is anticipated to be supported by further data from the STAR-2 trial and an open-label extension study.

    Additionally, DRMA is negotiating with possible partners for XYNGARI’s future cooperation and commercialization. Dermata Therapeutics (DRMA) is establishing XYNGARI as a potential addition to the acne treatment market with these ground-breaking findings, providing patients with a new, practical, and efficient choice.

  • Dermata Therapeutics (DRMA) Stock Faces Challenges Ahead

    Dermata Therapeutics Inc. (NASDAQ: DRMA) is a biotechnology company, which, as its name suggests, operates in the realm of dermatology. It aims to make a breakthrough in acne treatment, with its DMT310 candidate, yet recent updates demonstrate that severe challenges still lie ahead for DRMA stock.

    Dermata Shares Underwhelming Updates

    Earlier this month, Dermata Therapeutics Inc. (DRMA) reported on progress relating to its inflammatory skin disease candidate, DMT310. The management revealed that none of the primary endpoints could be attained within the study, despite no sign of any serious adverse conditions arising. The company has stated that despite the setback, it remains fully committed to proceeding with DMT310, and has even requested the FDA for a phase-2 end meeting. Management remains confident that the drug would establish itself as a viable acne treatment before March 2023.

    Financial Pressure Pushes on for DRMA

    In addition to facing disappointing trial update results for DMT310, Dermata is also faced with gradually mounting financial pressure, which cannot subside in the wake of poor results. The company’s cash holdings are down from $10.8 million to $8.1 million in less than a year. Although Dermata management states it has sufficient runway to fund operations until FY23Q3, the time is ticking for shareholders. Similarly, its R&D costs have doubled year-over-year from $800,000 to over $1.6 million. General and administrative expenses however remained constant over the year at $900,000. Additional funding could face challenges as a result of tight capital markets, and uncertainty regarding the prospects and viability of DMT310.

    Conclusion

    DRMA, like any biotech company, is one that is wrought with significant uncertainty. However, its immediate prospects appear challenging, given its failure to deliver, in terms of its DMT310 candidate. If the company successfully turns this around, it can tap into a multi-billion dollar global market, with relative ease.

  • Dermata Therapeutics, Inc. (DRMA) stock gained in the Pre-market; here is why?

    Dermata Therapeutics, Inc. (DRMA) stock gained in the Pre-market; here is why?

    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.

  • Dermata Therapeutics Inc. (DRMA) stock Continues Rising After Hours. Why?

    On January 24, Dermata Therapeutics Inc. (DRMA) stock advanced by a further 8.67% in the after-hours. Before that, the stock had already added 5.49% during the regular trading session.

    DRMA stock closed the regular session at $1.73, after fluctuating between $1.43 and $1.73. The stock went on to add a further $0.15 in the after-hours to reach $1.88 on Monday.

    Dermata Therapeutics Inc. which is a clinical-stage medical dermatology company has a market capitalization of $13.66 million. Currently, the company has 8.33 million shares outstanding in the market.

    DRMA stock Movement

    On January 13, the company announced the addition of a new director to its board. Following the announcement, the stock started gaining on January 14 and hence entered an uptrend. DRMA continued the uptrend till January 21, when it suffered some loss. The stock has since been once again on a bullish path.

    Although there is no new official announcement, SEC filing, or any upcoming event, DRMA has added 11.61% in the past five days. Moreover, the stock suffered a loss of 6.99% last month and 61.73% in the past three months.

    Recent Developments

    Recently, on January 13, DRMA announced the appointment of Brittany Bradrick to its Board as well as the Audit Committee. Ms. Bradrick has vast experience of over 25 years in finance, strategy, and corporate development for life science companies. Furthermore, she has served with Neurelis, ViaCyte, Insulet Corporation, Abbott Diabetes Care, and many others. Ms. Bradrick has served at various positions with these companies including CFO, COO, VC Strategy & Corporate Development, Head of Global Development, and others. Prior to this, she also served as the investment banker for the life science industry.

    Before that, the company participated in the H.C. Wainwright BioConnect Virtual Conference which took place on January 10-13, 2022. DRMA’s Chairman of the board, president and CEO, Gerry Proehl, presented an overview of the company at the conference.

    DRMA’s Financial Analysis

    On November 15, the company declared its financial results for the third quarter of 2021, which ended on September 30.

    In the third quarter of 2021, the company had research and development expenses of $0.8 million. Comparatively, R&D expenses were $0.1 million in the year-ago quarter.

    Additionally, the general and administrative expenses in Q3 2021 were $0.9 million against $0.4 million in Q3 of 2020.

    DRMA ended the third quarter with cash of $12.6 million on September 30, 2021.

  • Dermata Therapeutics Inc. (DRMA) Stock Surging in Aftermarket, Here’s the Reason

    Dermata Therapeutics Inc. (DRMA) Stock Surging in Aftermarket, Here’s the Reason

    Dermata Therapeutics Inc. (DRMA), a clinical-stage biotechnology company, has surged 8.52% on aftermarket trading session. As a result, DRMA stock is trading at $2.93 at the time of the writing. Analysts have attributed this rise to insider buying as the major owner of the company, Proehl Gerald, picked up 20,000 shares at a common stock price of $2.4 per share. On Friday, DRMA closed the day at $2.70 after declining 3.91% during regular trading hours. For the moment, let’s discuss recent developments of DRMA.

    DRMA Q3 2021 Operational Results

    On 16th November, DRMA released the operational and financial results for the third quarter of the fiscal year 2021. The quarter ended on 30th September. The company had cash of $12.6 million on 30th September 2021. The total operating expenses bore by the company during the period were $1.71 million against $0.54 million for the same period of 2020. The net loss suffered by the company during the three month period stood at $1.71 million against $0.59 million for the same period of 2020. The net loss per basic and diluted share for the period was $0.86 against $0.31 for the same period of 2020.

    Corporate Highlights

    Alongside the financial results, DRMA also shed a light on its corporate highlights. The company announced positive topline results from phase-1b POC Clinical Trial of DMT310 in Mild-to-moderate Psoriasis in late October. In August, it closed upsized $18 million initial Public Offering on Nasdaq Capital Market. It expanded its board of directors by appointing four experienced life sciences leaders to its BoD. In early September, it expanded its executive team by appointing Kyri Van Hoose as Chief Financial Officer.

    Executive Commentary

    Gerry Proehl, Chairman, President and Chief Executive Officer of DRMA, while commenting on the results said that the third quarter has proved to be a transformation for the company as it completed its IPO during the period. He hoped that in the future, the company would carry the momentum forward from its brilliantly ongoing studies and from the financial results it has achieved so far.

    Future Outlook for DRMA

    Analysts have predicted that DRMA is well on the track to achieve financial success in the upcoming quarters, as by then it would be able to achieve meets the targets that it has set for itself. So, a potential investor should closely keep watching the fluctuation of DRMA stock.