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Halberd Corp. Issues Letter to Shareholders

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Halberd (OTC PINK: HALB) issued a shareholder letter highlighting recent developments. The company's Tri-aX™ TBI nasal spray has shown promising results in preclinical studies at Mississippi State University for treating traumatic brain injury (TBI). The Department of Defense (DoD) selected Halberd's pre-proposal and invited a full application for funding up to $700,000 under the Emerging Topics Research Award.

The research will focus on establishing patterns of change in blood and brain biomarkers of injury at different TBI levels. Halberd emphasizes the need for secrecy regarding their proprietary formulation due to competitive concerns. The company plans to submit a detailed proposal by October 3rd and expects a decision within months.

Halberd (OTC PINK: HALB) ha pubblicato una lettera agli azionisti evidenziando gli sviluppi recenti. Lo spray nasale Tri-aX™ TBI dell’azienda ha mostrato risultati promettenti negli studi preclinici presso la Mississippi State University per il trattamento del trauma cranico (TBI). Il Dipartimento della Difesa (DoD) ha selezionato la proposta preliminare di Halberd e invitato a presentare un'applicazione completa per un finanziamento fino a $700,000 nell'ambito dell'Emerging Topics Research Award.

La ricerca si concentrerà sull'analisi dei cambiamenti nei biomarcatori ematici e cerebrali del ferimento a diversi livelli di TBI. Halberd sottolinea la necessità di mantenere riservata la loro formulazione proprietaria a causa di preoccupazioni competitive. L'azienda prevede di presentare una proposta dettagliata entro il 3 ottobre e si aspetta una decisione entro pochi mesi.

Halberd (OTC PINK: HALB) emitió una carta a los accionistas destacando los desarrollos recientes. El spray nasal Tri-aX™ TBI de la compañía ha mostrado resultados prometedores en estudios preclínicos en la Universidad Estatal de Mississippi para tratar lesiones cerebrales traumáticas (TBI). El Departamento de Defensa (DoD) seleccionó la propuesta preliminar de Halberd e invitó a presentar una solicitud completa para financiación de hasta $700,000 bajo el Premio de Investigación de Temas Emergentes.

La investigación se centrará en establecer patrones de cambio en los biomarcadores de sangre y cerebro de la lesión en diferentes niveles de TBI. Halberd enfatiza la necesidad de mantener en secreto su formulación patentada debido a preocupaciones competitivas. La empresa planea presentar una propuesta detallada antes del 3 de octubre y espera una decisión en unos meses.

Halberd (OTC PINK: HALB)는 최근 발전 상황을 강조하는 주주 서한을 발표했습니다. 회사의 Tri-aX™ TBI 비강 스프레이는 미시시피 주립대학교에서 외상성 뇌 손상(TBI) 치료를 위한 전임상 연구에서 유망한 결과를 보였습니다. 국방부(DoD)는 Halberd의 초기 제안을 선택하여 최대 $700,000까지의 자금 지원을 위한 전체 신청서를 초대했습니다.

이 연구는 다양한 TBI 수준에서 혈액 및 뇌 손상 바이오마커의 변화 패턴을 설정하는 데 중점을 두게 됩니다. Halberd는 경쟁 우려로 인해 자사의 독점 조제에 대한 비밀 유지의 필요성을 강조합니다. 이 회사는 10월 3일까지 상세한 제안을 제출할 계획이며, 몇 달 내에 결정을 기대하고 있습니다.

Halberd (OTC PINK: HALB) a émis une lettre aux actionnaires soulignant les développements récents. Le spray nasal Tri-aX™ TBI de l'entreprise a montré des résultats prometteurs dans des études précliniques à l'Université d'État du Mississippi pour le traitement des lésions cérébrales traumatiques (TBI). Le Département de la Défense (DoD) a sélectionné la proposition préliminaire de Halberd et invité à soumettre une demande complète de financement pouvant atteindre $700,000 dans le cadre de l'Emerging Topics Research Award.

La recherche se concentrera sur l'établissement de modèles de changement dans les biomarqueurs sanguins et cérébraux de la lésion à différents niveaux de TBI. Halberd souligne la nécessité de garder secrète sa formulation propriétaire en raison de préoccupations concurrentielles. L'entreprise prévoit de soumettre une proposition détaillée d'ici le 3 octobre et s'attend à une décision dans quelques mois.

Halberd (OTC PINK: HALB) hat einen Brief an die Aktionäre veröffentlicht, in dem die aktuellen Entwicklungen hervorgehoben werden. Das Tri-aX™ TBI Nasenspray des Unternehmens hat in präklinischen Studien an der Mississippi State University vielversprechende Ergebnisse zur Behandlung von traumatischen Hirnverletzungen (TBI) gezeigt. Das Verteidigungsministerium (DoD) hat Halberds Vorantrag ausgewählt und zur Einreichung eines vollständigen Antrags auf Finanzierung von bis zu $700,000 im Rahmen des Emerging Topics Research Award eingeladen.

Die Forschung wird sich darauf konzentrieren, Muster von Veränderungen bei Blut- und Hirn-Biomarkern von Verletzungen auf verschiedenen TBI-Ebenen festzustellen. Halberd betont die Notwendigkeit der Geheimhaltung bezüglich ihrer proprietären Formulierung aufgrund wettbewerblicher Bedenken. Das Unternehmen plant, bis zum 3. Oktober einen detaillierten Vorschlag einzureichen und erwartet innerhalb weniger Monate eine Entscheidung.

Positive
  • DoD selected Halberd's pre-proposal for Tri-aX™ TBI nasal spray, inviting a full application
  • Potential funding of up to $700,000 for research through DoD's Emerging Topics Research Award
  • Preclinical studies show promising results for Tri-aX in treating traumatic brain injury
  • Halberd/Athena team won two of three proposals submitted, a 66% success rate
Negative
  • Need for secrecy regarding proprietary formulation due to competitive concerns
  • Funding not yet secured, full proposal still needs to be submitted and approved

JACKSON CENTER, Pa., Aug. 26, 2024 (GLOBE NEWSWIRE) -- Halberd Corporation (OTC PINK: HALB) today issued the following letter to it shareholders:

Halberd Corp. - Taking a Moment to Recenter Our Technical Progress

Introducing Tri-axTM TBI Nasal Spray Treatment- the DoD selected our MSU-led pre-proposal, inviting us to submit a full application/proposal

This is the first of a series of three significant Press Releases we plan to issue shortly. Many of our investors have been voicing concern on how quiet things have been. We agree, but there is a good reason. We attempt to maintain transparency while carefully orchestrating communications to avoid disclosing our secret, proprietary methodologies. Things are changing here at Halberd as we mature our relationship with our key partners. Specifically, as Athena GTX’s CEO, Mark Darrah becomes a full working partner and takes on a full partner’s share of the Strategic Planning and Developments at Halberd, it has taken some time to sort out the best business plans going forward along with competitive, commercialization and legal strategies for Halberd’s evolving products. All together, we are critically focusing on the maximum nearer term returns on each of the technologies that address issues in the world today, putting significant efforts into obtaining government contract money, all the while, assuring we are legally protected with Non-Disclosure Agreements (NDA’s) and intellectual property agreements in place.

This Press Release focuses on the Tri-aX™ TBI nasal spray product evolutions and the recent military interest. It is of course very exciting news.

Dr. Darrah recently updated the technical product strategies in cooperation with the Halberd team and in light of the positive pilot programs completed at Mississippi State University under the auspices of Dr. Russell Carr. Knowing this general brain health arena after head trauma is an extremely hot military issue, as well as a commercial interest, Halberd must be cautious about public dissemination of information. It is both a litigious and highly competitive world.

Here is a summary:
Over the past year and a half, our research partner, Mississippi State University (MSU), being partially funded by Halberd, has conducted multiple preclinical studies using the novel nasally administered therapeutic Tri-aX spray. This formulation is proprietary. It is also susceptible to possible replication and appropriation. This formulation has revealed phenomenal results in testing to date, and looks to be a game changer to the issues of traumatic brain injury (TBI), and addresses primary and secondary injuries commonly seen in head trauma. Information such as specific combinations of therapeutic components and methodology of applications must, at least for now, remain secret.

These studies demonstrate the effectiveness of Tri-aX to ameliorate some of the negative effects that occur following TBI. Initially, it was established that repeated daily administration of Tri-aX reduced the level of tissue biomarkers of neurological damage specifically in the brain following TBI. This suggests that Tri-aX can be effective at preventing some of the long-term effects associated with TBI. Consultation with military key researchers at the Office of Naval Research (ONR and the US Army) and preliminary discussions with a few key regulatory contacts suggested our next steps, which we cannot yet reveal. With compelling tissue data, we now move to blood biomarkers and will validate and verify the tissue data while also looking at time courses of those markers and at different levels of injury (mild, moderate and severe TBI).

More recently, we observed in ongoing preparatory work at MSU, that a single treatment administered shortly after trauma can reduce the behavioral deficits induced by TBI. Based on these findings, a pre-proposal white paper entitled, "Rapid Point of Injury Treatment of Traumatic Brain Injury with the Intranasally Administered Novel Therapeutic Tri-aX," was submitted to the Department of Defense (DoD) to obtain significant funding to continue our studies. There were multiple questions generated from Subject Matter Experts (SME’s) through Athena that dictates our pathway forward.

Fueled by our most compelling results, on August 8, the DoD notified us that Halberd’s Mississippi State-led pre-proposal was selected. The submitted White Paper outlining our planned efforts was selected after reviews of many competitive alternatives. The DoD extended an invitation for us to submit a full application or proposal.

The research to be proposed in the application will focus on establishing the patterns of change over time in blood and brain biomarkers of injury. Many of these are currently being proposed for use as diagnostic indices of TBI severity. In addition, the research will also establish the pattern of functional recovery. Determining these patterns at different levels of TBI will establish a baseline to which therapeutic intervention with Tri-aX can be compared.

We are quite pleased with the military’s decision and feel the new efforts will not only provide much needed research funding, but also align with the product development goals provided to us during preparation. We expect a full proposal submittal to be sent in within weeks and a formal military decision within a couple of months.

The successfully selected proposed effort was through the Department of Defense, Defense Health Program, Congressionally Directed Medical Research Programs (CDMRP), under the DOD Traumatic Brain Injury and Psychological Health, Emerging Topics Research Award, under ID HT942524TBIPHRPETRA

Emerging Topics Research Award, Research, a new area, as a Level 1, which includes a contract award of up to $700,000. This is the first year this contract has been offered by the military.

Awards are supported with FY24 funds and will be made no later than September 30, 2025. The CDMRP expects to allot approximately $16.0M to fund approximately four ETRA Research Level 1 applications and five ETRA Research Level 2 applications.

Here are the 2023 chances of awards under CDMRP:

  • Clinical Trial Award: 238 proposals, 83 recommended. 35% approval rate.
  • Emerging Topics Research Award: First time being offered.
  • Focused Program Award: 60 proposals, 11 were recommended. 18% approval rate.
  • Health Services Research Award: 21 proposals, 6 were recommended. 29% approval rate.
  • Translational Research Award: 234 proposals, 38 recommended. 16% approval rate.

Overall, the industry has an 11 to 14% success rate. That in part was why the Halbert team chose this solicitation source. As a heads up and in anticipation of our next PR, our team won two of three proposals submitted for a 66% success rate for the Halberd/Athena Team!! Our detailed proposal is due October 3rd.

Sincerely,

William A. Hartman and Dr. Mark Darrah

To get the latest on Halberd’s exciting developments, subscribe by submitting this form.
(https://halberdcorporation.com/contact-us/).

For more information, please contact:
William A. Hartman
w.hartman@halberdcorporation.com
support@halberdcorporation.com
www.halberdcorporation.com
Twitter:@HalberdC

About Mississippi State University College of Veterinary Medicine (CVM).
Established in 1974, the Mississippi State University College of Veterinary Medicine (MSU CVM) comprises six locations, catering to all 82 counties in Mississippi and the broader Southeastern United States. The primary campus, situated in Starkville, encompasses the Wise Center, home to the main teaching hospital known as the Animal Health Center. The faculty and staff of the MSU CVM Department of Comparative Biomedical Sciences cover fundamental scientific disciplines essential for veterinary education. MSU CVM is dedicated to an ethical approach in the treatment of animals, demonstrating a sincere passion and commitment.

About Athena GTX, Inc.
Athena GTX is a certified DoD small business with Corporate Headquarters in Johnston, Iowa. Athena focuses development on wearables and highly mobile, wirelessly connected monitoring technologies, and transitioning those to key markets to meet unmet needs of first responders worldwide. Wireless Patient Monitoring – Athena GTX connects patient and provider About - Athena GTX® Inc.

About Halberd Corporation.
Halberd Corporation (OTC PINK: HALB), is a publicly traded company on the OTC Market, and is in full compliance with OTC Market reporting requirements. Since its restructuring in April of 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 value to its stockholders and to attract the interests of 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 our readers that statements, and assumptions made in this news release constitute forward-looking statements and makes no guarantee of future performance. Forward-looking statements are based on estimates and opinions of management at the time the statements are made. These statements may address issues that involve significant risks, uncertainties and associated estimates made by management. Actual results could differ materially from current projections or implied results. Halberd Corporation undertakes no obligation to revise these statements following the date of this news release.
(C) 2024, Halberd Corporation


FAQ

What is Halberd 's new product for traumatic brain injury?

Halberd (HALB) has developed Tri-aX™, a novel nasal spray treatment for traumatic brain injury (TBI). Preclinical studies at Mississippi State University have shown promising results in reducing neurological damage and behavioral deficits associated with TBI.

Has Halberd (HALB) received any government interest in their TBI treatment?

Yes, the Department of Defense (DoD) selected Halberd's pre-proposal for their Tri-aX™ TBI nasal spray and invited the company to submit a full application for funding under the Emerging Topics Research Award.

How much potential funding could Halberd (HALB) receive for their TBI research?

Halberd could potentially receive up to $700,000 in funding from the Department of Defense for their Tri-aX™ TBI nasal spray research if their full proposal is approved.

When is Halberd (HALB) expected to submit their full proposal for DoD funding?

Halberd is expected to submit their detailed proposal for DoD funding by October 3rd, 2024. A decision on the funding is anticipated within a couple of months after submission.

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