How Science Meets A.I.
But This Delivery System Is Pure Biology And The Efforts Of Dr. Stephen Gould In Collaboration With Capricor Therapeutics
The success of Capricor Therapeutics 3-year safety and efficacy results from its ongoing HOPE-2 open-label extension (OLE) study for its lead asset, deramiocel. The fact of cardiac degeneration with orthopedic complications causes progressive muscle weakness in which the results for CAP-1002 have been remarkable in holding off these complications.
The most recent corporate event involving Capricor Therapeutics (NASDAQ: CAPR) on October 18, 2024, the company announced the closing of its underwritten public offering, raising approximately $86.3 million in gross proceeds (Capricor).I have found throughout my lifetime investing, especially when companies dilute their issued and outstanding shares, many times institutional shareholders, retail investors, they tend to be quite negative.The investors who remain extremely positive, such as myself, in these market event, have done their extensive research and analysis, in what I love to call “Money Math” or fundamental analysis in quantitating risk to reward.
The overwhelming recent Hope-2 and final ongoing Hope-3 phase 3 trial reported results are significant milestones being game changers as met to date in the writing of this article. Most recently, the options markets were tending towards large put contracts over call contracts called the put to call ratio. This actually occurred with CAPR, in though a reversal of fortune being a surprising upward trend, not allowing the usual short sellers and hedge fund investors moving the bid to ask price spreads considerably lower in share price. Why is this the case for Capricor? Assessing the pros and cons gives important insight.
Pros:
• Increased Capital: The successful offering has provided Capricor with substantial funds to support its research and development programs, potentially accelerating the advancement of its therapeutic candidates.
• Enhanced Visibility: The public offering and recent positive data from clinical studies, such as the HOPE-2 open-label extension (OLE) study for deramiocel in Duchenne Muscular Dystrophy, have increased the company’s visibility within the biotech sector (Capricor).
• Strategic Collaborations: Capricor has engaged in strategic partnerships, including a binding term sheet with Nippon Shinyaku for European expansion and commercialization of deramiocel (Morningstar).
Cons:
• Market Volatility: Despite the successful offering, biotechnology stocks can be subject to significant market fluctuations, which may impact investor sentiment and stock performance.
• Regulatory Challenges: The company intends to file a Biologics License Application for full approval of deramiocel (Morningstar). The regulatory approval process can be lengthy and uncertain, potentially affecting timelines and outcomes.
As of the latest data, Capricor Therapeutics’ stock is trading at $18.86 per share, reflecting a 1.89% increase at close of market Friday the 18th of 2024.
In summary, Capricor Therapeutics has recently achieved significant milestones, including a successful public offering and positive clinical data. However, the company continues to navigate challenges inherent in the biotechnology industry, such as market volatility and regulatory hurdles.
The real piece of the incredible puzzle is the ability of what has been created with full patents written across all exosome transport systems being as brilliant as the discoveries being heavily invested in as A.I.such as Nvidia as a multi trillion dollar valued company. We learn in moments such as these, the StealthX trademark platform is certainly one of those rare game changers which can easily catapult Capricor reaching, as we believe, price targets between $55 - $77 dollars a share near-term, with an extensive 12 to 24 month period of $385 dollars a share.
The StealthX™ platform developed by Capricor Therapeutics CAPR is an exosome-based technology designed to deliver therapeutic agents such as proteins, RNA, and small molecules directly into cells. Exosomes are naturally occurring extracellular vesicles that facilitate cell-to-cell communication by transporting various bioactive molecules, including nucleic acids, proteins, and lipids. These vesicles are derived from the body's own cells, making them an excellent, biocompatible delivery system with a lower risk of immune rejection compared to synthetic alternatives like liposomal nanoparticles.
Key Features of StealthX™:
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Targeted Delivery: Exosomes can be engineered to target specific cell types, which is crucial for diseases like cancer, where treatments need to be delivered precisely to malignant cells without affecting healthy tissues. This precision reduces side effects and improves the therapeutic outcome.
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Multivalent Payloads: The StealthX™ platform can carry multiple types of therapeutic agents at once, making it versatile for a wide range of applications. This could be particularly useful in the development of multivalent vaccines (targeting several pathogens or strains at once) or cancer therapies, where a combination of drugs is often needed to combat tumor cells that might otherwise develop resistance.
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Natural and Safe: Since exosomes are part of the body's natural cell communication system, they can circulate in the body for extended periods without being rapidly cleared by the immune system. They also avoid triggering the inflammatory responses often associated with synthetic delivery systems.
Applications in Cancer and Other Therapeutics:
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Cancer Therapies: Many pharmaceutical companies are exploring exosome-based platforms like StealthX™ for cancer treatment because of the ability to specifically target tumor cells. For example, they can deliver small interfering RNA (siRNA) or microRNA (miRNA) to silence cancer-causing genes, or carry chemotherapeutic agents directly to cancer cells, reducing systemic toxicity.
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Vaccines: Exosome-based delivery systems are also being investigated for vaccines. For instance, the StealthX™ platform is being used to develop multivalent vaccines for infectious diseases like COVID-19
. These exosomes can deliver viral antigens directly to immune cells, improving immune responses with potentially fewer doses compared to traditional vaccines. -
Gene Therapies: In gene therapy, exosomes can be utilized to deliver genetic material such as mRNA, CRISPR components, or DNA for gene editing, making them invaluable for treating genetic disorders or diseases that require altering cellular functions at the molecular level.
Why Pharmaceutical Companies May Need Platforms Like StealthX™:
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Scalability: As exosome production technologies improve, it becomes possible to produce large quantities of these vesicles for therapeutic use, which is necessary for widespread applications like vaccines or chronic disease treatments.
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Personalized Medicine: The versatility of exosomes allows them to be engineered for personalized medicine approaches, where therapies are tailored to the genetic makeup of individual patients, a direction many pharmaceutical companies are moving towards, particularly in oncology.
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Reduction of Side Effects: Targeted delivery systems like StealthX™ are likely to become critical as the pharmaceutical industry looks to minimize the side effects of potent treatments, such as chemotherapy, by ensuring that only the affected cells are treated.
In conclusion, exosome-based platforms like StealthX™ represent a future in which drug delivery becomes more precise, personalized, and efficient. Pharmaceutical companies focusing on cancer, vaccines, and gene therapies are particularly likely to adopt such systems because of their ability to deliver complex therapeutic payloads with fewer side effects, making them essential for next-generation treatments being sought by those competing for the FDA's BLA approvals.
We have acquired a substantial position in CytoDyn CYDY over this past summer with average cost basis $..2475 cents per share; as this many call basically Penny-stock, holding much higher or highest Risk to Reward investment outcomes, unless, as we had also purchased a good amount of shares of CAPR at an average price $2.97a share over a time period of four years. The same as with Mesoblast MESO average cost basis $3.39 a share. All actually have a lot more potential positives than to negatives in current market conditions.
We have remained committed and focused in providing extensive transparency with the regulatory framework when writing and publishing our articles. Our research and analysis is our own due diligence, but we completely recommend you seek professional investment advice on any and all positions in corporations we may be either invested into long or short positions and or options. Our success is not to be considered as it’s without complete loss of your potential investment in any of the securities we either mention or have discussed in our publication articles out of you yourself have done your own research and analysis and best due diligence.
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KEEPING YOUR EYE ON THE TRUTH CAN BE A DIFFERENCE BETWEEN BEING IN $CAPR INSTEAD OF OUT OF A LONG POSITION.
President-elect Donald Trump has nominated Dr. Marty Makary, a surgeon and public policy researcher at Johns Hopkins University, to lead the U.S. Food and Drug Administration (FDA). Dr. Makary is known for his criticism of certain public health measures during the COVID-19 pandemic and has advocated for reducing bureaucratic obstacles within federal health agencies.
Dr. Makary’s approach to the FDA’s drug approval process emphasizes streamlining procedures to expedite the availability of treatments for serious conditions, such as Duchenne Muscular Dystrophy (DMD). He has expressed concerns about the agency’s “cozy relationship” with drug manufacturers and has criticized specific FDA decisions, including the approval of certain COVID-19 vaccines and Alzheimer’s treatments.
The FDA has recently approved several treatments for DMD, including:
• Elevidys (delandistrogene moxeparvovec): A gene therapy approved in June 2023 for pediatric patients aged 4 through 5 years with a confirmed mutation in the DMD gene.
• Duvyzat (givinostat): An oral medication approved in March 2024 for the treatment of DMD in patients six years and older, representing the first nonsteroidal drug approved for all genetic variants of DMD.
Dr. Makary’s potential leadership could influence the FDA’s approach to approving such treatments. While his intent to reduce bureaucratic delays may accelerate the availability of new therapies, his critical stance on certain FDA decisions suggests he may implement more stringent evaluation processes to ensure drug efficacy and safety.
In summary, Dr. Makary’s nomination indicates a potential shift in the FDA’s drug approval process, aiming to balance expedited access to treatments for diseases like DMD with rigorous scientific evaluation to maintain public trust and safety.