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Relief Therapeutics Hldg AG (OTC: RLFTF) Gaining as RLF-100 (aviptadil) Top Line Data Looms

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Microcapdaily continues to cover the exciting story of Relief Therapeutics Holding SA (SWX: RLF) (OTCQB: RLFTF) that skyrocketed up the charts earlier this year as its covid-19 treatment RLF-100 (aviptadil) continues to show significant potential to treat patients who are already in the Intensive Care Unit (ICU) with Respiratory Failure. The drug is currently in advanced clinical trials and compassionate use data released earlier this year shows compelling results with a number of covid-19 patients on ventilators returning home in only five days after treatment with RLF-100. According to a recent main stream news article on Fox “Patients had a nine-fold chance of survival and recovery from respiratory failure, after being treated with RLF-100. The drug is simple to manufacture and cheap to produce at scale and if the clinical trials reflect the compassionate use date, RLF-100 should easily get approval from the FDA

Recently speaking to CNBC Relief Chairman Ram Selvaraju said the ongoing Phase 2b/3 trial with RLF-100 is expected to provide topline data in January while attributing the explosive rise in share price to evidence of the efficacy of RLF-100 in “otherwise untreatable patients.” This comes shortly after Relief and its partner NeuroRx, met the 165 enrollment target in ongoing trial of RLF-100, which is a patented version of aviptadil, in critically-ill COVID-19 patients with respiratory failure. Aviptadil is a synthetic form of the human Vasoactive Intestinal Peptide which reduces inflammation in the lungs and protects the alveolar type II cells. Early stage results from expanded access use of RLF-100 have shown a 72% of those that were admitted into the ICU survived. In June, the FDA granted fast-track designation to RLF-100, as well orphan drug tag for acute respiratory distress syndrome.

Relief Therapeutics Holding SA (SWX: RLF) (OTCQB: RLFTF) focuses primarily on clinical-stage programs based on molecules of natural origin (peptides and proteins) with a history of clinical testing and use in human patients or a strong scientific rationale. Currently, Relief is concentrating its efforts on developing new treatments for respiratory disease indications. Relief was fonded by former executives of Merck.

Relief’s lead drug candidate RLF-100TM (aviptadil), synthetic vasoactive intestinal peptide (VIP), is being investigated in two placebo-controlled U.S. phase 2b/3 clinical trials in respiratory deficiency due to COVID-19. RLF-100TM is believed to be the first COVID-19 therapeutic to demonstrate the ability to block replication of the SARS-CoV-2 virus in human lung cells and monocytes, while also preventing synthesis of cytokines in the lung. Since July 2020, severe COVID-19 patients have been treated with RLF-100TM under U.S. FDA Emergency Use Investigational New Drug (IND) authorization and Expanded Access Protocol authorization for the treatment of respiratory failure in COVID-19. Relief also holds a patent issued in the United States and various other countries covering potential formulations of RLF-100TM. RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF.

Relief’s partner; NeuroRx is led by former senior executives of Johnson & Johnson, Eli Lilly, Pfizer, and AstraZeneca including CEO Dr. Jonathan Javitt who is leading the trial of Aviptadil. Dr. Javitt has an impressive background. He’s the CEO of Neuro-RX, an adjunct professor at Johns Hopkins University and. He has held healthcare leadership roles under four presidents of the United States.Relief is listed on the Swiss Exchange under the symbol RLF and quoted in the U.S. on the OTCQB under the symbol RLFTF.

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After the recent Extraordinary General Meeting (“EGM”) Relief has elected Tom Plitz as new member of the Board of Directors. Tom is Chief Executive Officer of Chord Therapeutics SA, a privately held biopharmaceutical firm based in Geneva, Switzerland. Peter Egon de Svastich resigned his position as a member of the Board of Relief. The members of the Relief Board of Directors now are Raghuram (Ram) Selvaraju (Chairman), Thomaz Burckhardt and Tom Plitz.  The EGM approved the increase in the compensation pool available for the remuneration of members of the Board of Directors from CHF 1,000,000 to CHF 1,500,000 for the period from the Ordinary General Meeting 2020 until the Ordinary General Meeting 2021. Similarly, an increase in the remuneration of management was approved in the amount of CHF 5,000,000 for the financial year 2021. The EGM approved the modification of the authorized share capital from 1,056,726,052 shares to 1,250,000,000 shares and an increase of the conditional share capital from 740,329,636 shares to 960,000,000 shares. As explained in the EGM invitation, recent issuances of 620,000,000 new shares out of the conditional share capital 3b2 were not yet reflected in the Articles of Association. In addition, 86,658,667 new shares were issued from the conditional share capital 3b2 after publication of the EGM invitation. A total of 706,658,667 shares were already issued prior to the EGM and were therefore included in the increased amount of the conditional share capital 3b2 as set forth in the Articles of Association immediately after the EGM, resulting in an available conditional share capital 3b2 of 253,341,333 shares.

Earlier this month Relief and its partner NeuroRx announced they met the 165 patient enrollment target agreed with the U.S. Food and Drug Administration (FDA) in the ongoing phase 2b/3 trial of RLF-100™ (aviptadil) for treating Respiratory Failure in patients with Critical COVID-19. Respiratory Failure is defined, according to the FDA, as the need for intensive care with mechanical ventilation, non-invasive ventilation, or high-flow nasal oxygen in order to sustain adequate levels of blood oxygen.

There is currently no FDA-approved drug that has shown efficacy in patients who are already in the Intensive Care Unit (ICU) with Respiratory Failure. In addition to the ongoing phase 2b/3 trial, more than 200 patients with Critical COVID-19 and respiratory failure have been treated in an FDA-approved, Expanded Access Protocol (EAP) for RLF-100™. These patients were unable to enter the phase 2b/3 randomized trial due to severe comorbidities (such as organ transplant, recent heart attack, or cancer). While the companies have focused first on those patients who have no medical alternative and are at immediate risk of death, a phase 2b/3 trial with  RLF-100™ for inhaled use in patients with moderate and severe COVID-19 in order to prevent progression to respiratory failure is expected to start soon.

Although the phase 2b/3 study will remain blinded until the final patients reach day 28, unexpected rapid recovery on chest X-ray has been reported by study sites and frequently reported in the open-label Expanded Access Protocol as well. In the EAP, of the 90 patients who have reached 28 days post-treatment, 72% have survived to day 28.  The clinical trial will continue to enroll patients through the anticipated early Q1 2021 announcement of top line data in order to amass as large a safety database as possible. To date, no drug-related Serious Adverse Event has been reported in any of the ongoing studies of RLF-100, which is consistent with the absence of toxicity seen in extensive nonclinical safety testing and prior human studies.

Prof. Jonathan Javitt, CEO and founder of NeuroRx stated: “Although enrollment has been uniquely challenged by the devastating effects of the pandemic, straining the capacity of hospitals and exposing our investigators and study coordinators to personal peril from COVID-19 in the course of their duties, we are proud to meet our enrollment target as planned. Achieving this milestone in the midst of the pandemic has only been possible because of the extraordinary dedication of the doctors, nurses, pharmacists, and study coordinators who continued to work around the clock to develop this much-needed therapy.

https://twitter.com/Summer97708624/status/1338511696176893957

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Microcapdaily continues to cover the exciting story of Relief Therapeutics that skyrocketed up the charts earlier this year as its covid-19 treatment RLF-100 (aviptadil) continues to show significant potential to treat patients who are already in the Intensive Care Unit (ICU) with Respiratory Failure. The drug is currently in advanced clinical trials and compassionate use data released earlier this year shows compelling results with a number of covid-19 patients on ventilators returning home in only five days after treatment with RLF-100. According to a recent main stream news article on Fox “Patients had a nine-fold chance of survival and recovery from respiratory failure, after being treated with RLF-100. The drug is simple to manufacture and cheap to produce at scale and if the clinical trials reflect the compassionate use date, RLF-100 should easily get approval from the FDA. Recently speaking to CNBC Relief Chairman Ram Selvaraju said the ongoing Phase 2b/3 trial with RLF-100 is expected to provide topline data in January while attributing the explosive rise in share price to evidence of the efficacy of RLF-100 in “otherwise untreatable patients.” This comes shortly after Relief and its partner NeuroRx, met the 165 enrollment target in ongoing trial of RLF-100, which is a patented version of aviptadil, in critically-ill COVID-19 patients with respiratory failure. Aviptadil is a synthetic form of the human Vasoactive Intestinal Peptide which reduces inflammation in the lungs and protects the alveolar type II cells. Early stage results from expanded access use of RLF-100 have shown a 72% of those that were admitted into the ICU survived. In June, the FDA granted fast-track designation to RLF-100, as well orphan drug tag for acute respiratory distress syndrome. We will be updating on Relief on a daily basis so make sure you are subscribed to microcapdaily.com so you know what is going on with Relief.

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Disclosure: we hold no position in Relief either long or short and we have not been compensated for this article.

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2 Comments

2 Comments

  1. Bill Sivula

    December 23, 2020 at 2:34 pm

    “The drug is simple to manufacture and cheap to produce at scale…” Theoretically, simple and cheap. But not UNTIL the actual process is developed, proven, approved by FDA (or other relevant supervising agencies), and geared up. Apparently Bachem has sought (or still is seeking) specialized people since the contract(s) were signed, to implement such a process. What can later be described as “simple and cheap”, probably has many costly (in both money and time) steps.
    Note: I am a reader of Yahoo Finance’s RLFTF (ticker symbol) ‘Community’ blog, though the blog includes URL references to other sources, including this website. (And also a concerned investor.)

  2. Norbert Castella

    December 27, 2020 at 6:21 am

    J’aimerais continuer à suivre l’extraordinaire aventure médicale de cette Société Relief qui, pour moi, représente le seul espoir, pour le moins un espoir majeur, dans la tragédie de cette pandémie.

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LAVA Therapeutics (NASDAQ: LVTX) Gammabody™ Platform Gains Momentum

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LAVA Therapeutics N.V. (NASDAQ: LVTX) shares soared 106% as the company announced that Janssen Biotech, Inc. chose a lead candidate.

LAVA Therapeutics N.V. (NASDAQ: LVTX) shares soared 106% as the company announced that Janssen Biotech, Inc., a part of the Janssen Pharmaceutical Companies of Johnson & Johnson, chose a lead candidate aimed at an undisclosed tumor-associated antigen for further development towards clinical settings.

GAMMABODY™ PLATFORM

LAVA primarily focuses on revolutionizing cancer therapy by developing its Gammabody™ platform. This platform enables them to create bispecific gamma delta T cell engagers that can activate a specific subset of gamma-delta T cells called Vγ9Vδ2 (Vgamma9 Vdelta2) T cells. By utilizing this approach, they aim to enhance the natural recognition of tumors, guide Vγ9Vδ2 T cells to target the tumor cells directly and trigger a cascade of immune responses.

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What sets their Gammabody™ drug candidates apart is their exceptional performance and safety profiles observed in preclinical studies. Compared to other bispecific T cell engager approaches, their candidates have demonstrated superior efficacy and preferred targeting tumor cells. This targeted approach has the potential to minimize toxicity in healthy tissues.

In May 2020, LAVA entered into a research collaboration and license agreement with Janssen, a subsidiary of the Janssen Pharmaceutical Companies of Johnson & Johnson. This collaboration aimed to discover and develop novel bispecific antibody-based gamma delta T cell engagers for cancer treatment. The agreement was facilitated by Johnson & Johnson Innovation, emphasizing their commitment to fostering innovation in the field.

As part of the collaboration, LAVA had the opportunity to receive potential milestone payments and royalties based on the successful development, regulatory approvals, and commercialization of the candidates. This incentivized LAVA to actively pursue the discovery and advancement of promising lead candidates. 

The collaboration represents a remarkable milestone many early-stage biotech companies aspire to achieve. Partnering with a program brings numerous benefits, including reduced risk of dilution through milestone payments as the trials advance and streamlined commercialization once the product receives approval.

Under the terms of the agreement, Janssen will assume responsibility for the selected candidate’s future clinical development, manufacturing, and commercialization. This includes bearing the costs and expenses associated with these activities.

Stephen Hurly, LAVA Therapeutics’s president and chief executive officer, expressed satisfaction with Janssen’s selection of a lead candidate for clinical studies. He emphasized LAVA’s pioneering role in developing gamma-delta bispecific antibodies through their proprietary Gammabody platform. This platform and LAVA’s extensive expertise in bispecific antibody development position them at the forefront of advancing novel therapies for cancer patients.

In summary, LAVA Therapeutics’ collaboration with Janssen has reached a significant milestone in selecting a lead candidate for further development toward clinical studies. This progress underscores LAVA’s dedication to leveraging its Gammabody platform and expertise in bispecific antibody development to revolutionize cancer treatment.

We will update you on LVTX when more details emerge, so make sure you are subscribed to Microcapdaily to know what’s happening in the markets!

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Disclosure: We have not been compensated for this article/video. MicroCap Daily is not an investment advisor; this article/video does not provide investment advice. Always do your research, make your own investment decisions, or consult with your nearest financial advisor. This article/video is not a solicitation or recommendation to buy, sell, or hold securities. This article/video is our opinion, is meant for informational and educational purposes only, and does not provide investment advice. Past performance is not indicative of future performance.

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Onfolio Holdings (NASDAQ: ONFO) Unleashing the Power of AI

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Onfolio Holdings Inc (NASDAQ: ONFO), a technology services company, has recently introduced an advanced generative AI search function for its subsidiary, MightyDeals.com.

Onfolio Holdings Inc (NASDAQ: ONFO), a technology services company, has recently introduced an advanced generative AI search function for its subsidiary, MightyDeals.com. The implementation of this innovative AI tool, powered by chatGPT-style Large Language Models (LLMs), has resulted in a surge of 105% in the company’s stock price and sparked tons of investor interest. The company has a 3.28M float and, at the time of writing, has traded 20x that amount, with a colossal 60M shares exchanging hands.

Revolutionizing User Experience and Driving Stock Surge

With the integration of AI search on MightyDeals.com, customers can now use natural language to describe the products they seek, simplifying the buying process. The AI tool utilizes contextual understanding and description analysis of hundreds of active deals to generate instant search results based on users’ queries. By enhancing the user experience, Onfolio Holdings anticipates increased user return rates, higher site interaction rates, and elevated revenues for MightyDeals.com. This groundbreaking development has attracted positive attention, significantly increasing Onfolio Holdings’ stock price.

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Evaluating Financial Performance

While the stock surge indicates investor enthusiasm, assessing Onfolio Holdings’ financial performance is crucial for comprehensive investment analysis. The positive earnings growth of +44.44% and revenue growth of +22.74% contribute to the company’s optimistic outlook. However, investors should be cautious of the negative net profit margin of -190.75% and the lack of available price/book ratio data. Monitoring the company’s financial performance leading up to the next reporting date on August 30, 2023, is advised to understand its profitability and overall stability better.

Investment Outlook and Future Prospects

Considering the stock surge and optimistic price forecasts, Onfolio Holdings has promising prospects. Analysts offer a median target price of $3.00 for the company’s stock, signaling an expectation of significant growth within the next 12 months. However, it is essential to note that Onfolio Holdings operates at a loss. Investors should thoroughly evaluate the company’s long-term growth potential and weigh the potential returns against the inherent risks before making investment decisions.

About MightyDeals.com

Mighty Deals is a free daily deals website aimed at creative professionals focusing on products and services for web designers and developers. The site offers fantastic deals on quality fonts, templates, apps, add-ons, plug-ins, ebooks, icons, and more. The site provides discounts on packages which usually range between 50%-97% off but are only available for a limited time. MightyDeals.com boasts an exceptional return rate from its users and is one of Onfolio Holdings’ highest revenue-generating subsidiaries.

About Onfolio Holdings Inc.

Onfolio acquires and manages a diversified portfolio of online businesses across a broad range of verticals, each with a niche content focus and brand identity. Onfolio acquires firms that meet its investment criteria, being that such businesses operate in sectors with long-term growth opportunities, have positive and stable cash flows, face minimal threats of technological or competitive obsolescence, and can be managed by our existing team or have strong management teams largely in place. The Company excels at finding acquisition opportunities where the seller has not fully optimized their business. Onfolio’s experience and skillset allow it to add increased value to these existing businesses.

Conclusion

Onfolio Holdings’ introduction of the generative AI search function for MightyDeals.com has increased the company’s stock price, reflecting the market’s positive response to this innovative technology. The enhanced user experience and the potential for increased revenues have positioned Onfolio Holdings as a leader in the tech industry. However, investors must carefully consider the company’s financial performance and evaluate its long-term growth potential before making investment decisions. Monitoring the company’s performance to the next reporting date will provide valuable insights into its financial health and stability.

We will update you on ONFO when more details emerge, so make sure you are subscribed to Microcapdaily to know what’s happening in the markets!

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Disclosure: We have not been compensated for this article/video. MicroCap Daily is not an investment advisor; this article/video does not provide investment advice. Always do your research, make your own investment decisions, or consult with your nearest financial advisor. This article/video is not a solicitation or recommendation to buy, sell, or hold securities. This article/video is our opinion, is meant for informational and educational purposes only, and does not provide investment advice. Past performance is not indicative of future performance.

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Enveric Biosciences (NASDAQ: ENVB) Pioneering the Future of Anxiety Disorder Treatment

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Enveric Biosciences, Inc. (NASDAQ: ENVB) shares surged 78% this morning upon approval of some fantastic news.

Enveric Biosciences, Inc. (NASDAQ: ENVB) shares surged 78% this morning upon approval of some fantastic news. The United States Patent and Trademark Office has granted them a notice of allowance for their patent application concerning a groundbreaking chemical compound called EB-373. This compound is being developed to address the treatment of anxiety disorders.

The forthcoming patent, titled “C4-Carbonothioate-Substituted Tryptamine Derivatives and Methods of Using,” encompasses claims for the composition of matter of a family of revolutionary prodrug derivatives of psilocin. Enveric’s lead product candidate, EB-373, stands out among these derivatives. A Notice of Allowance signifies that the USPTO has determined that a patent should be granted based on the submitted application.

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Enveric’s commitment to innovation extends beyond EB-373. They have also submitted additional patent applications to the USPTO, exploring psilocin prodrugs with unique crystalline molecular structures. Moreover, they have taken proactive steps to pursue global coverage of the EVM201 and EVM301 Series through companion Patent Cooperation Treaty and non-US national patent applications. Encouragingly, positive International Search Reports and written opinions have been received under the Patent Cooperation Treaty for most of these applications.

Joseph Tucker, Ph.D., Enveric’s director and CEO, underlined the significance of the USPTO’s favorable decision concerning their lead candidate, EB-373. He highlighted the innovative designs of their psilocin prodrugs within the EVM201 series, differentiating them from conventional counterparts like psilocybin. These novel designs hold the potential to deliver more rapid therapeutic effects, precise control, and reduced gastrointestinal side effects. Tucker emphasized that securing a robust intellectual property portfolio for their new chemical entity prodrugs is pivotal to Enveric’s value proposition and integral to their business strategy of developing cutting-edge small-molecule therapeutics to address mental health disorders.

We will update you on ENVB when more details emerge, so make sure you are subscribed to Microcapdaily to know what’s happening in the markets!

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Disclosure: We have not been compensated for this article/video. MicroCap Daily is not an investment advisor; this article/video does not provide investment advice. Always do your research, make your own investment decisions, or consult with your nearest financial advisor. This article/video is not a solicitation or recommendation to buy, sell, or hold securities. This article/video is our opinion, is meant for informational and educational purposes only, and does not provide investment advice. Past performance is not indicative of future performance.

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