$HALB Halberd Corp. Issues Letter to Shareholders
https://www.globenewswire.com/en/news-release...lders.html
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.
https://www.globenewswire.com/en/news-release...lders.html
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.
