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RLF-100™ (Aviptadil) Relief Therapeutics Holding AG (OTCMKTS: RLFTF) Heats Up Fast

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Relief Therapeutics Holding AG (OTCMKTS: RLFTF) is surging up the charts in recent trading since a recent test of the bottom of its current trading range. Relief Therapeutics is quickly emerging as among the most exciting stories in small caps as its coronavirus therapeutic RLF-100 (aviptadil) gains serious traction. The Company recently raised approximately USD $36 million which will be used primarily to fund the ongoing Fast Track FDA trial of RLF-100 (aviptadil) in coronavirus acute respiratory distress syndrome (NCT04311697) as well as to run a phase 3 study in Europe.

RLFTF took off in the last week of July after the FDA granted expanded access protocol for treatment of Respiratory Failure in COVID-19 with RLF-100. The Company has come a long way since then recently reporting highly encouraging topline efficacy data from patients treated with RLF-100™ (aviptadil) under the U.S. FDA Expanded Access Protocol authorization for respiratory failure related to critical COVID-19. Investors are looking forward to the upcoming results from the randomized, double-blind, prospective trial.

Relief Therapeutics Holding SA (OTCMKTS: RLFTF) is a biopharmaceutical company with its lead compound RLF-100TM (aviptadil) in advanced clinical development to treat severe COVID-19 patients. Operating out of Switzerland, the Company is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on the OTCQB under the symbol RLFTF.

Relief lead product; RLF-100™ (aviptadil) is a formulation of Vasoactive Intestinal Polypeptide (VIP) that was developed based on Prof. Sami Said’s original work at Stony Brook University, for which Stony Brook was awarded an FDA Orphan Drug Designation in 2001. VIP is known to be highly concentrated in the lungs, where it inhibits coronavirus replication, blocks the formation of inflammatory cytokines, prevents cell death, and upregulates the production of surfactant. RLF-100 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-100 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. FDA has now granted IND authorization for intravenous and inhaled delivery of RLF-100™ for the treatment of COVID-19 and awarded Fast Track designation. RLF-100™ is being investigated in two placebo-controlled US Phase 2b/3 clinical trials in respiratory deficiency due to COVID-19. Since July 2020, more than 150 patients with Critical COVID-19 and Respiratory Failure have been treated with RLF-100™ under FDA-approved protocols. Relief Therapeutics (OTC:RLFTF) makes it into the Coronavirus Technology Watch Program which is administered by the US Department of Health and Human Services.

Relief and its partner NeuroRx have established supply chain agreements and ordered sufficient drug substance (RLF-100TM) to prepare to treat 1 million patients with COVID-19. The partners contracted with Nephron Pharmaceuticals, Inc., Bachem Americas, as well as a leading nationwide pharmaceutical logistics partner in order to ensure overnight commercial supply to US hospitals, should RLF-100™ continue to succeed.

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RLFTF

Relief continues to beef up its BOD and management team recently appointing Jack Weinstein as Chief Financial Officer (CFO) and Treasurer. The Company has also appointed Dr. Gilles Della Corte as Chief Medical Officer. The Company also appointed Virtuoso Sarl, a strategic and tactical operational and trial delivery services firm, as Clinical Trials Manager to set up and run RLF-100 clinical trials in Europe. Relief successfully upgraded from US OTC Pink to OTCQB, meeting all qualifications and raised $34.4 million via its Share Subscription Facility in July and August.

On October 13 Relief reported topline results from 45 patients assessed in an open-label prospective study where 21 patients admitted to an intensive care unit (ICU) with critical COVID-19 and respiratory failure were treated with RLF-100™(aviptadil) and compared to 24 control patients treated in the same setting. All patients had severe comorbidities that rendered them ineligible for the ongoing randomized controlled phase 2b/3 trial being conducted to ascertain safety and efficacy of RLF-100™, and all patients were deteriorating despite treatment with approved therapies for COVID-19.

Overall, 81% of RLF-100™-treated patients survived beyond 60 days, compared to 17% of control patients. Patients treated with RLF-100™ demonstrated a 9-fold increased probability of survival and recovery from respiratory failure, with a high degree of statistical significance. Statistical analysis was performed by Prof. Phil Lavin, FASA, FRAPS of the Boston Biostatistical Research Foundation.Scientific findings of the analysis have been submitted for peer review.

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RLFTF recently reported highly encouraging topline efficacy data from patients treated with RLF-100™ (aviptadil) under the U.S. FDA Expanded Access Protocol authorization for respiratory failure related to critical COVID-19. Jihad Georges Youssef, MD, section chief of General Academic Pulmonary Medicine at the Houston Methodist Hospital, who serves as the study’s principal investigator at Houston Methodist and also serves as national co-chair for the ongoing randomized controlled trial stated: “We are encouraged by these initial results in highly comorbid patients with COVID-19 respiratory failure, and we are pleased that the majority of these patients have returned safely to their families. We look forward to the upcoming results from the randomized, double-blind, prospective trial in less severely comorbid patients for confirmation of these results.” Raghuram (Ram) Selvaraju, Chairman of the Board of Relief commented: “The encouraging EAP topline data give us continued motivation to remain focused on the rapid clinical development of RLF-100™. We look forward to topline results from our randomized, placebo-controlled study this quarter. We remain dedicated to our goal of providing therapeutic relief to critical COVID-19 patients as quickly as possible.” Microcapdaily covers Relief on the regular and first reported on the Company on August 3 as Relief was running northbound off its $0.05 base. 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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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.

Image by James from Pixabay

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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.

Image by Gino Crescoli from Pixabay

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