Early data from a pilot study of volunteer veterans are compelling

JACKSON CENTER, Pa., Sept. 4, 2024 (GLOBE NEWSWIRE) — Halberd Corporation (OTC: HALB)

To our shareholders:

As promised, this is the second of three press releases on our recent progress. If you missed the opportunity to check out the last one, which was about the good news about our Tri-aX nasal spray for TBI, please do so. This one follows the same process. This press release focuses on LDN+ as it relates to post-traumatic stress disorder (PTSD) and reducing suicide among veterans. To make it easier to get feedback from our investors, we are splitting it into two parts.

This is Part A. I hope this doesn’t confuse anyone. Part B will be released in a few days. As always, please reach out if you have any comments or thoughts. Good or bad, we appreciate them!

The PTSD market is evolving with advances in treatment options, increased awareness, and growing demand for supportive services, reflecting the critical need for comprehensive care for those affected by PTSD. The inventive domain of our emerging intellectual property (IP), now referred to as WatchDawg, combines a patented drug (LDN+) with complementary therapies and monitoring. In recent months, after three defeats in the proposed Department of Defense (DoD) LDN+ effort, we recognized that we were not attracting the military’s attention solely with LDN+ and the widespread message that there was no medical “cure” for PTSD or any other form of mental illness. However, we conducted an in-depth review and concluded that combining approaches in parallel with drug therapy could provide hope for patients. We evolved the term LDX as an advanced pharmaceutical based on LDN+ therapy and enhanced complementary therapies, along with novel technology for 24/7 patient monitoring. This was a breakthrough and we recently gained interest from the military. More on this later.

The pilot program began a few weeks ago, as reported. Our solution appears to be working and working well. Our initial clinical data on the combination formulation ((LDX)based on a major modification of the patent describing LDN+, with a diverse target group of patients. In contrast to the issued patents on LDN+ by Dr. Mitchell S. Felder, we currently believe that the selection of LDN-based therapy as a novel drug therapy in itself it just won’t work. Of course, that’s debatable, but the data from our pilot study to date refute that. So over the last few months, and especially since we started the pilot, we’ve adapted. The therapies we choose have to be complementary to a comprehensive approach. The path to FDA approval for LDX is evolving with guidance from the FDA, a solid group of regulatory consultants, and Institutional Review Board (IRB) input and guidance. The plan is to begin safety and efficacy studies of the pharmaceutical product as soon as possible, while continuing to market and distribute WatchDawg with LDX as a “combined solution” or as a single drug therapy with two FDA-approved LDX subcomponents, with a select number of nutraceuticals, psychological support services, proven Exalted Warrior yoga and meditation therapy, and 24/7 physiological monitoring of participants to supplement therapeutic interventions.

The story continues

Combined invention. What this invention encompasses, which is currently filed as a provisional patent and is unique to the markets, is the combination of low doses of FDA approved ingredients, pharmaceutical application, CBD/CBN based nutraceuticals, monitoring and therapy in a patient portal providing 24/7 connectivity between care providers and patients. When combined, this approach is uniquely suited to treating a variety of disease states common to humans, not relying on FDA approval. Our compiled data indicates that it works. Early trends include lower heart rates, lower stress levels, improved heart rate variability (which is good), higher sPO₂and most interestingly, the data shows significantly reduced data variability (more stable physiology) in terms of vital signs in therapy in contrast to the underlying data before therapyThe differences in these minimal patients are so far convincing!

This now suggests a much closer timeline for revenue generation than anticipated, while FDA approval in parallel goes through different stages. At this point main desire is to avoid the classic FDA Investigational New Drug (IND) classification, and 3+ years and a big expense, in exchange for a simpler approach. That’s good, because we simply don’t have the money. With the staggering numbers of veteran suicides per day, it made sense to follow FDA guidelines, and also get to market faster without alleged violations. What this invention describes is a closer-range, lower-risk, lower-cost alternative to an IND. Because the pharmacy does not require FDA approval if administered as separate capsules or pills or mixed into a single capsule under current FDA guidelines for compound pharmacymakes sense to proceed without an IND or the required FDA approval as a prerequisite.

Main square. We have launched this new business strategy with the goal of helping to reduce the suicide rate among veterans. The lasting impact of war is the development Post-traumatic stress disorder (PTSD) and accompanying mental health issues in our veterans. PTSD is not only prevalent in veterans, but also in the general non-military population. As of 2024, Global Post-Traumatic Stress Disorder (PTSD) Treatment and Management Market estimated at about From 12 to 15 billion dollars. This Compound Annual Growth Rate The PTSD treatment market segment is expected to have a compound annual growth rate (CAGR) of approximately 8% to 10% over the next few years. This growth rate is high and reflects the growing demand for more effective treatments and interventions for PTSD due to various factors. This market includes various components related to the diagnosis, treatment, and support for people suffering from PTSD and other related mental health problems, as well as substance abuse, anger, anxiety, and depression.

Key Elements of Our WatchDawg Approach for the PTSD Market:

1. Pharmaceutical products: Standard clinical treatment includes antidepressants (such as SSRIs and SNRIs) and anti-anxiety medications used to: manage symptoms PTSD. Specific medications such as sertraline and paroxetine are often prescribed. We developed LDN+ and now LDX, and have added other CBD/N-based nutraceutical therapies.

2. Therapeutic services: Various forms of psychotherapy, including cognitive behavioral therapy (CBT), eye movement desensitization and reprocessing (EMDR), and trauma-focused therapy, have been identified as key components of PTSD treatment. This often includes individual counseling, group therapy, and peer support programs to help individuals cope with and recover from PTSD. We have added our proprietary blend of yoga and meditation, which has proven particularly effective for veterans fortunate enough to experience the Exalted Warrior technique.

3. Digital Health Solutions: PTSD symptom management apps that offer therapeutic exercises and mindfulness and relaxation techniques are becoming more common. We support this. But we are different. The industry is now providing telehealth services, i.e. remote therapy and counseling services that provide accessibility and convenience for those seeking treatment for PTSD. We have added the WatchDawg platform for near real-time vital signs (NRT) monitoring and the app via a cloud platform. We have also developed the PAWS system architecture and launched it as part of WatchDawg. We will explain this in detail in Part B.

4. Support and rehabilitation programs: Veterans and Soldiers Programs have specialized programs and services for veterans and active duty military personnel, including VA facilities and military-specific PTSD treatment programs. In addition, Trauma-informed care programs incorporate trauma-informed approaches to provide supportive care for those affected by PTSD. All of this, the combination of what we offer with WatchDawg with our cloud-based application it surpasses what is currently available on the market.

5. Research and development: We also know that there are many research programs focused on developing new treatments, therapies, and interventions for PTSD, as well as other mental health issues. These include research into new medications, therapeutic techniques, and digital health interventions. We are currently in a pilot study that will soon move to Phase 1 and then to a comprehensive study with 150 participants safety and effectiveness study in combination WatchDawg monitoring and therapies.

In Part B, we will expand on these areas and describe the approach and our recent successes with the military. So far, we have evidence that we are on the right track and well ahead of our original timeline for launch. Rarely does a day go by without another veteran or addict calling or texting/emailing us to say they have heard about our work and would like to be a part of it.

William A. Hartman AND Dr. Mark Darrah

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For more information, please contact:
William A. Hartman
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[email protected]
www.halberdcorporation.com
Twitter: @HalberdC

About Athena GTX, Inc.
Athena GTX is a DoD Certified Small Business headquartered in Johnston, Iowa. Athena focuses on developing wearable devices and highly mobile, wirelessly connected monitoring technologies and their transition into key markets to address the unmet needs of first responders worldwide. Wireless Patient Monitoring – Athena GTX Connects Patient and Provider About the Company – Athena GTX® Inc.

About Halberd Corporation.
Halberd Corporation (OTC: HALB) is a publicly traded company listed on the OTC market and fully complies with OTC market reporting requirements. Since its restructuring in April 2020, Halberd has obtained exclusive worldwide rights to three issued patents and has filed 22 related provisional, PCT or utility patent applications to enhance its shareholder value and attract interest from potential development partners.

Safe Harbor Notice
Certain statements contained herein are “forward-looking statements” (as defined in the Private Securities Litigation Reform Act of 1995). The Company cautions its readers that the statements and assumptions contained in this press release constitute forward-looking statements and are not guarantees of future results. Forward-looking statements are based on the estimates and opinions of management at the time the statements are made. These statements may address matters that involve significant risks, uncertainties and related estimates made by management. Actual results may differ materially from current projections or implied results. Halberd Corporation undertakes no obligation to revise these statements after the date of this press release.

(C) 2024, Halberd Corporation

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