Media & Technology
CytoDyn Inc (OTCMKTS: CYDY) Gaining as Vyrologix (leronlimab-PRO 140) Top Line Data Looms
CytoDyn Inc (OTCMKTS: CYDY) is making an explosive move up the charts in recent weeks on a massive wave of buy volume and heavy accumulation from investors which is increasing rapidly. Recently the Company reported full enrollment in its Phase 3 registrational trial for patients with severe-to-critical COVID-19. The 390-patient data will be analyzed in approximately 28 days, with expected results to be announced shortly thereafter. CytoDyn is simultaneously finalizing an EUA application with the Philippine FDA with patient data from CD10 and recent eINDs for severe-to-critical patients
Microcapdaily reported on CYDY on December 9 the last time because we saw the market change that day and CYDY had an energy it had not had since earlier this year on the way up to $10.01 per share. The massive accumulation that fueled that rise was back on December 9 and has been growing since than with CYDY now over $5 and well on its way to take out previous highs.
CytoDyn Inc (OTCMKTS: CYDY) is a biotechnology company focused on developing innovative treatments for multiple therapeutic indications. Its lead candidate Leronlimab (PRO 140) belongs to a new class of therapeutics called viral-entry inhibitors and is one of the most advanced experimental monoclonal antibodies for HIV treatment. Leronlimab is a wunderdrug that has turned Cytodyn fortunes around from a wanna be to the monster it is now.. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH. Leronlimab has completed nine clinical trials in over 800 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).
CytoDyn completed its Phase 2 clinical trial (CD10) for COVID-19, a double-blinded, randomized clinical trial for mild-to-moderate patients in the U.S. which produced statistically significant results for NEWS2. CytoDyn completed enrollment of 390 patients in its Phase 2b/3 randomized clinical trial for the severe-to-critically ill COVID-19 population and expects to release results in mid-January 2021.
CYDY now has the same energy behind it that propelled the stock to $10 the last time and Investors are excited. JWR a respected biotech expert stated on Cytodyn yesterday:
- The run to $5 is a real run based on the growing Covid epidemic and completion of the CD12 trial. Those hoping to short this baby to make back their losses will be in panic mode as the price continues to trip up with more and more events.
- CD12 being statistically significant is a no-brainer brainer. DSMB gave strong hints in their interim review. While improving SOC is reducing mortality, it ain’t working for those that are put into a leronlimab trial and, therefore, will not significantly have an impact. Given the safety record with significantly less severe SAE’s than SOC, there is only upside. This combines with no penalty to the p-value needed means very high confidence. And…for a state the obvious refutement against those saying it actually is water: it ain’t.
- Leronlimab WILL get EUA by end of January in the US and UK. FDA/OWS is watching and well aware of leronlimab. You don’t need Columbo to follow the clues here. The addition of codes for leronlimab added to the CMS, the statements by NP that FDA has unblinded access as well as additional comments regarding OWS interest. The confirmation by TI and others on responses from Dr. Woodcock who heads thereapeutics for OWS. To state the obvious twice, FDA does not want to do EUA before trial completion as it compromises the ability to complete the trial. Now that the trial is complete…you may just be surprised.
- OWS will make a sizeable investment to ramp up production in the US. Dr. Woodcock has acknowledged in interviews that a vaccine is only part of the arsenal against Covid. It’s a no brainer that leronlimab needs to be in that arsenal.
- Leronlimab MAY get EUA approval in the Philippines by end of year depending on budget approval
- UPLIST will happen…and soon. Me thinks early January we will be up listed.
- HIV approval for US or UK has NOT been factored into the stock price. The BLA will get filed at least for the MHRA and possibly for US by end of January at the latest.
- Other applications have mammoth potential. Post viral syndrome (eg., long hauler), Stroke, NASH (and Crosby, Stills and Young), stroke, will be game changers and bring in bank.
- The risk profile of shorts has flip-flopped.
- All of my predictions will be between 30-60% wrong.
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On December 15 CYDY announced it had reached full enrollment in its Phase 3 registrational trial for patients with severe-to-critical COVID-19. The 390-patient data will be analyzed in approximately 28 days, with expected results to be announced shortly thereafter. On October 20, 2020, following review and recommendation by the Data Safety Monitoring Committee (DSMC) of data from 195 patients, the Company continued the trial without modification to achieve the primary endpoint. The DSMC also requested a second review of the data after 75% (or 293) of the patients were enrolled and completed a 42-day post-enrollment period. The Company has concluded it will be far more time efficient to forego the second interim analysis and to analyze the data on 390 patients and to provide final data to the U.S. Food and Drug Administration, Health Canada, U.K.’s MHRA, and Philippines FDA, as soon as it is available.
CytoDyn’s Phase 2b/3 trial to evaluate the efficacy and safety of leronlimab for patients with severe-to-critical COVID-19 indications is a two-arm, randomized, double blind, placebo controlled, adaptive design multicenter study. Patients are randomized to receive weekly doses of 700 mg leronlimab, or placebo. Leronlimab and placebo are administered via subcutaneous injection. The study has three phases: Screening Period, Treatment Period, and Follow-Up Period. The primary outcome measured in this study is: all-cause mortality at Day 28. Secondary outcomes measured are: (1) all-cause mortality at Day 14, (2) change in clinical status of subject at Day 14, (3) change in clinical status of subject at Day 28, and (4) change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 14.
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented, “We are very thankful for the concerted efforts by so many healthcare professionals to reach full enrollment so quickly in these trying times. To the best of our knowledge, we are the first company to complete a Phase 3 trial for COVID-19 severe-to-critical population. Currently, there are hundreds of thousands of patients around the globe with an immediate need for a safe and efficacious therapeutic to combat this horrific pandemic. Since the Philippine FDA has relaxed the criteria of EUA for any safe drug with any efficacy data, we will file our EUA as soon as the presidential order is implemented by the Philippine FDA with all of the information we currently have available, which we believe could occur within the next couple of weeks. The Company is working diligently to ensure a sufficient supply of drug product is available to meet the urgent needs of patients.”
https://twitter.com/swhutton/status/1340712942078205953
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Microcapdaily reported on CYDY on December 9 the last time because we saw the market change that day and CYDY had an energy it had not had since earlier this year on the way up to $10.01 per share. The massive accumulation that fueled that rise was back on December 9 and has been growing since than with CYDY now over $5 and well on its way to take out previous highs. We noted earlier this month that CMS recently provided a DRG Code for leronlimab so Medicare and Medicaid can reimburse for leronlimab starting after January 1 if it is approved which seems more and more likely every day. The FDA has been following the leronlimab trials carefully. The Company is serious about up-listing to a national exchange as announced in previous press and that coupled with possible FDA approval in January could prove catastrophic for shorts who are well aware we are once again rapidly closing in on $10.01 per share. We will be updating on CYDY when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with CYDY.
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Disclosure: we hold no position in CYDY either long or short and we have not been compensated for this article.
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.
My big % winning day trade today was $LVTX.
All I did was follow the system.
It has a small float.
Fresh meet never pumped before.
Big News out.
Giant volume.
Why I jumped in early and took profits on the spike in volume. pic.twitter.com/2knPeC5RHz— Trader Brian Jones (@MasterBJones) June 2, 2023
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.
$LVTX $66mil mcap, $133mil in cash at the end of December, cash runway into 2026, median price target $13 (443% upside)
— Jake Weber (@BioStockAnalyst) June 2, 2023
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.
$LVTX has three gamma-delta t cell drug candidates in early-stage trials, including collaboration with $SGEN for solid tumors.
— Jake Weber (@BioStockAnalyst) June 2, 2023
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.
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
$onfo in news and float are lit pic.twitter.com/7afKMOfdz2
— …frankyboyz… (@frankyboyz77) May 26, 2023
With the integration of AI search on MightyDeals.com, customers can now use natural language to describe the products they seek, simplifying the buying process. The AI tool utilizes contextual understanding and description analysis of hundreds of active deals to generate instant search results based on users’ queries. By enhancing the user experience, Onfolio Holdings anticipates increased user return rates, higher site interaction rates, and elevated revenues for MightyDeals.com. This groundbreaking development has attracted positive attention, significantly increasing Onfolio Holdings’ stock price.
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$ONFO just took the elevator to the top!
Now just waiting on $CYTO pic.twitter.com/OfJgNb1ty0
— 💎 DBR 💎 (@dbr_land) May 26, 2023
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.
*says the word "AI" once
* $ONFO +76% at market open pic.twitter.com/gOLBZjlqJ2
— Commonstock (@JoinCommonstock) May 26, 2023
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.
$onfo in news and float are lit pic.twitter.com/Q8eIveRfgd
— …frankyboyz… (@frankyboyz77) May 26, 2023
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.
$ONFO #Ai have you seen this stock? Just came out with a competitive AI software that will fight against the tech kings #microsoft #google
— Don’t Look Down (@M_1Ball) May 26, 2023
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.
$ONFO – "AI program" is laughable. Check it out on https://t.co/0LdCQCWC28. I searched for "shoes" and flower bouquets showed up. I put in a search for "dogs" and african animals came up.
Plus, lockup expiry is tomorrow, so this is a blatant pump and dump: pic.twitter.com/QnYVoDnqqr
— Adam Gefvert, CFA (@Shiningboy) May 26, 2023
We will update you on ONFO when more details emerge, so make sure you are subscribed to Microcapdaily to know what’s happening in the markets!
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Disclosure: We have not been compensated for this article/video. MicroCap Daily is not an investment advisor; this article/video does not provide investment advice. Always do your research, make your own investment decisions, or consult with your nearest financial advisor. This article/video is not a solicitation or recommendation to buy, sell, or hold securities. This article/video is our opinion, is meant for informational and educational purposes only, and does not provide investment advice. Past performance is not indicative of future performance.
Enveric Biosciences, Inc. (NASDAQ: ENVB) shares surged 78% this morning upon approval of some fantastic news. The United States Patent and Trademark Office has granted them a notice of allowance for their patent application concerning a groundbreaking chemical compound called EB-373. This compound is being developed to address the treatment of anxiety disorders.
The forthcoming patent, titled “C4-Carbonothioate-Substituted Tryptamine Derivatives and Methods of Using,” encompasses claims for the composition of matter of a family of revolutionary prodrug derivatives of psilocin. Enveric’s lead product candidate, EB-373, stands out among these derivatives. A Notice of Allowance signifies that the USPTO has determined that a patent should be granted based on the submitted application.
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$ENVB halted up
— Antonio Costa (@ACInvestorBlog) May 18, 2023
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.
$ENVB 💰💰💰💰💰 pic.twitter.com/qCIxiCpF0E
— FonsieTrader (@FonsieTrader) May 18, 2023
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.
$ENVB 👇this is an important milestone for the company! The price could increase fivefold wit the time imo.
Enveric Biosciences Receives Notice Of Allowance From US Patent And Trademark Office For Novel Prodrug Of Psilocin
— Swingy John (@daytrader_2020) May 18, 2023
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!
Subscribe to Our 100% Free Penny Stock Newsletter. We Have Something Big Coming!
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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