Monday, November 18, 2024

BioFuse Medical Technologies Appoints Dr. David Battleman as Chief Executive Officer

 

Source:  BioFuse Medical Technologies, Inc. 3/26/2024

Proven healthcare executive and life sciences strategist joins to bring groundbreaking BioFuse Multi-Tissue Welder (MTW) technology to market

BioFuse Medical Technologies, a leading developer of radio frequency (RF) technology for surgical welding, today announced that David Battleman, MD, MBA, MSc, has been appointed as its President & Chief Executive Officer. Dr. Battleman brings a wealth of experience that strongly aligns with the company's commitment to advancing healthcare through innovative surgical solutions and will lead BioFuse through the development and launch of the company's RF surgical welding devices.

Dr. Battleman is the Principal & Founder of TrueNorth Lifesciences, a boutique life science strategic consulting and financial advisory firm, and has over 20+ years of working with highly innovative life science companies seeking to optimize and accelerate growth. Previously, Dr. Battleman served as a Senior Principal in the R&D and Commercial Strategy Practice of IMS Health Holdings, Inc. (now IQVIA; NYSE: IQV), a Fortune 500 company providing data and consulting services to the global pharmaceutical industry. Prior to joining IMS Health, he was a management consultant at Bain & Company and Sr. Director for Pfizer Pharmaceuticals. Dr. Battleman holds an MD from Weill Cornell Medical College, an MBA from the University of Pennsylvania's Wharton School of Business, and an MSc from the Harvard School of Public Health.

Dr. David Battleman's appointment as the CEO signifies a strategic advancement for BioFuse as the company positions itself at the forefront of surgical innovation. The BioFuse Board of Directors believes that Dr. Battleman's extensive experience in healthcare & life science technology development & commercialization makes him an ideal leader to guide BioFuse through its next phase of growth. Commenting on BioFuse's technology, Dr. Battleman stated, "I am excited to join BioFuse Medical Technologies at this critical juncture as the company advances its highly innovative Multi-Tissue Welding technology through late-stage development & commercialization. BioFuse MTW, as a multi-tissue welding device, has the potential to revolutionize a significant number of surgical procedures that require sutures or staples, improve patient recovery times, and address critical challenges in healthcare cost management."

Dr. Joseph Stauffer, Chairman of BioFuse Medical Technologies, expressed his enthusiasm for the new leadership, saying, "We are confident that Dr. Battleman's extensive background in healthcare, capital markets, and strategic leadership will further propel BioFuse towards achieving its mission. His appointment comes at a pivotal time for our company, and we look forward to the positive impact his expertise will have on advancing our innovative surgical solutions."

Saturday, November 16, 2024

Comstock Completes GenMat Transaction

 

Source:  Comstock, Inc. 11/13/2024

Strategic Investment in Artificial Intelligence for Materials Discovery in Energy Applications

Comstock Inc. (NYSE: LODE) (“Comstock” and the “Company”) today announced the acquisition of 100% of the equity of GenMat Licensing LLC (“AICo”) in exchange for 100% of the Company’s equity in Quantum Generative Materials LLC (“GenMat”). AICo holds a non-exclusive end user right and license (“EULA”) to use GenMat’s now and hereafter existing artificial intelligence (“AI”) for materials science technologies, services and products, as well as all current satellite imaging and other data, analytics, and artificial intelligence and other models relating to Comstock’s mining properties in Nevada. AICo also holds a credit against the amounts payable under the EULA equal to 100% of the Company’s cumulative historical investments in GenMat.

“Our interest in artificial intelligence reflects the critical need to develop and use artificial intelligence for materials science and mineral discovery, especially for breakthrough energy applications in our current and future addressable markets,” said Corrado De Gasperis, Comstock’s executive chairman and chief executive officer. “Artificial intelligence is even more critical today, as rapidly evolving AI platforms have begun to accelerate the pace of global innovation and redefine industries and competitive requirements. We look forward to further developing and integrating these solutions into our businesses.”

GenMat is expected to continue developing its commercial materials science discovery platform (“ZENOMDP”) and its proprietary artificial general physics intelligence technologies (“AGPI”). In the meantime, the capabilities of commercially available AI technologies are accelerating at increasing rates, including the creation of generative, physics-based AI technologies such as GenMat’s ZenoMDP, that are new and demonstrate high potential for harnessing known science and enhancing the innovation, commercialization, and scaling of new technologies in exponentially shorter cycle times.

Important and promising use cases for developing, commercially available physics-based AI technologies include materials science applications with new arrangements of atoms, molecules, and physical systems, as well as enhancing industrial chemical processes. Each application offers tremendous potential for Comstock’s existing lines of business, such as by accelerating new catalysts, decreasing carbon intensities, decreasing development costs, decreasing capital costs and increasing throughput and profitability.

Kevin Kreisler, Comstock’s chief technology officer, added, “Incorporating the bleeding edge of emerging physics-based AI technologies into our focused and purposeful innovation efforts will dramatically enhance our capacity to rapidly develop and scale solutions for producing, distributing, storing, and using energy more effectively, expediently and efficiently, thereby accelerating the rate that we commercialize our solutions, enabling systemic decarbonization and generate exceptional shareholder value.”

Mr. Kreisler leads Comstock’s ongoing technology development and commercialization efforts, including as part of Comstock’s growing innovation capabilities, projects, and partner networks.

About Comstock Inc.

Comstock Inc. (NYSE: LODE) commercializes innovative technologies that contribute to global decarbonization and the clean energy transition by efficiently converting under-utilized natural resources, primarily, woody biomass into low-carbon renewable fuels, end-of-life metal extraction and renewal, and generative AI-enabled advanced materials synthesis and mineral discovery for sustainable mining.

Comstock to Acquire Quantum Generative Materials LLC

 

Source:  Comstock, Inc. 10/7/2024

Strategic Investment in Artificial Intelligence for Materials Discovery in Energy Applications

Comstock Inc. (NYSE: LODE) (“Comstock” and the “Company”) today announced the execution of an agreement by Comstock, Deep Interstellar Research LLC (“DIR”), and Quantum Generative Materials LLC (“GenMat”) under which Comstock effectively acquired substantially all of the equity in GenMat, including GenMat’s artificial intelligence materials discovery platform, materials synthesis, and related assets, business, and most of the related technical team. Concurrently, as part of the acquisition of GenMat, Deep Prasad’s holding company will be receiving GenMat’s consolidated satellite, mission control software, other related low earth orbit assets, and space team. As a result of the transaction, Comstock will own substantially all of GenMat’s issued and outstanding equity and continue development and commercialization of its breakthrough physics-based artificial intelligence products and services to discover new materials and other technologies, primarily for decarbonizing energy.

“Our interest in GenMat was and remains grounded in the critical need and use of artificial intelligence for materials science and mineral discovery, for breakthrough energy applications and other mature industries with large addressable markets,” said Corrado De Gasperis, Comstock’s executive chairman and chief executive officer. “Artificial intelligence is even more critical today, as rapidly evolving AI platforms have begun to accelerate the pace of global innovation and redefine industries and competitive requirements. Frankly, anyone that is not integrating AI into their core competencies and capacities will likely either be disrupted or completely replaced.”

OpenAI’s ChatGPT employs a generative large language model to generate new, valuable information for a wide range of use cases at orders of magnitude faster than what was previously possible. GenMat’s AI operates similarly, but instead of generating words and language for a wide range of use cases, it generates new atoms, molecules, and physical systems for a wide range of materials applications, harnessing aspects of humanity’s collective knowledge of physics and chemistry combined with proprietary synthetic datasets to discover new materials in an exponentially shorter time than traditional methods have allowed.

Kevin Kreisler, Comstock’s chief technology officer, added, “focusing and building on GenMat’s team and competencies in materials science, computational chemistry, and computational machine learning, while incorporating the bleeding edge of emerging artificial intelligence technologies will reinforce our competitive advantages in our metals, mining, and fuels businesses, while dramatically expanding our existing innovation capacity as we continue to develop more advanced solutions for enabling systemic decarbonization.”

Since our initial investment in 2021, GenMat has built an exceptional team and achieved a series of critical milestones in materials simulation and synthesis, in addition to successfully launching its orbital imaging and remote sensing satellite, developing its proprietary mission control software, and commencing commercial sales in its space business.

“Deep Prasad positioned GenMat for an extraordinary second opportunity commercializing satellite development, manufacturing and management that requires different skills and dedication,” continued De Gasperis. “Launching a new company that will leverage GenMat’s existing space-based assets evolved as the logical, win-win solution that allowed our respective companies to maximize the value of each enterprise, with Comstock fully owning and dedicating to GenMat, and Deep fully dedicated to, owning, and leading the new space-based enterprise.”

“GenMat is one of the world’s first physics-based AI for materials science startup companies,” added Deep Prasad, GenMat’s founder and former chief executive officer. “We couldn’t be prouder of our accomplishments in materials simulation and synthesis, and the emerging opportunities with space-based systems and technologies. We are excited with Comstock’s plans to build on our work to date, and our ability to now fully dedicate and focus on building our space-based technologies, assets, and operations.”

“The strategic value of leveraging physics-based AI cannot be overstated,” concluded Kreisler. “AI will allow us to build on our competitive advantages in this rapidly changing world, while positioning us to generate extraordinary shareholder value as we fulfill our mission to enable systemic decarbonization by innovating, developing, commercializing, and monetizing new technologies for producing, distributing, storing, and using energy more efficiently.”

Mr. Kreisler will lead the management of GenMat’s ongoing technology development and commercialization efforts, including as part of Comstock’s growing innovation capabilities, projects, and partner networks.

Technology Readiness Level

Comstock uses the technology readiness scale to estimate the readiness of technology from conception to commercialization, iterating sequentially as follows: (i) TRL 1 (basic principles observed and reported); (ii) TRL 2 (technology concept and application formulated); (iii) TRL 3 (analytical and experimental proof of concept); (iv) TRL 4 (validation in laboratory environment); (v) TRL 5 (pre-pilot scale validation in relevant environment); (vi) TRL 6 (pilot prototype demonstration in relevant environment); (vii) TRL 7 (scaled-up commercial prototype in operational environment); (viii) TRL 8 (commercial system demonstration); (ix) TRL 9 (commercial maturity).

GenMat’s materials discovery AI is at TRL 3 in some applications. GenMat is focused on the minimum sufficient requirements for simulating and synthesizing breakthrough new materials for use in energy applications at TRL 6, followed by both commercialization and integration into Comstock’s businesses.

Comstock’s original 2021 investment agreement with GenMat called for a milestone-based investment of $50,000,000 for 50% of GenMat’s fully diluted equity, including about $15,000,000 previously paid by Comstock. Comstock and GenMat agreed to terminate each of their prior agreements as part of the new acquisition agreement. Comstock expects to efficiently operate, integrate, and commercialize GenMat.

About Comstock Inc.

Comstock Inc. (NYSE: LODE) commercializes innovative technologies that contribute to global decarbonization and the clean energy transition by efficiently converting under-utilized natural resources, primarily, woody biomass into low-carbon renewable fuels, end-of-life metal extraction and renewal, and generative AI-enabled advanced materials synthesis and mineral discovery for sustainable mining.

Comstock Executes Exclusive License and Cooperative Research and Development Agreement with Department of Energy’s National Renewable Energy Laboratory


 Source:  Comstock, Inc. 10/4/2024

World Class Innovation Team Set Sights on 100% Renewable Sustainable Aviation Fuel and Fossil Parity

Comstock Inc. (NYSE: LODE) (“Comstock” and the “Company”) today announced the execution by Comstock’s wholly-owned subsidiary, Comstock IP Holdings LLC, of an Exclusive License Agreement (“ELA”) and Cooperative Research and Development Agreement (“CRADA”) with Alliance for Sustainable Energy LLC (“Alliance”), the managing and operating contractor of the U.S. Department of Energy’s (“DOE”) National Renewable Energy Laboratory (“NREL”), involving technologies developed by NREL and the Massachusetts Institute of Technology (“MIT”) for conversion of lignocellulosic biomass into aromatic sustainable aviation fuel (“SAF”). NREL and MIT are separately party to an Inter-Institutional Agreement that appointed NREL the exclusive right to license NREL’s and MIT’s joint intellectual properties, and Comstock IP Holdings previously granted Comstock Fuels Corporation the master exclusive rights for commercialization of its existing and new renewable fuels technologies.

Comstock’s Existing Process

Comstock Fuels offers advanced lignocellulosic biomass refining solutions that produce market-leading yields of cellulosic ethanol, gasoline, renewable diesel, SAF, and other renewable fuels at extremely low carbon intensities. The Comstock Fuels process generally involves: (1) solvolytic digestion and fractionation of lignocellulosic biomass, (2) bioconversion of cellulose into Cellulosic Ethanol, (3) esterification of lignin and other derivatives into Bioleum Oil, (4) hydrodeoxygenation of Bioleum Oil into Hydrodeoxygenated Bioleum Oil (“HBO”), (5) refining of the resulting intermediates into ASTM compliant renewable fuels, and (6) gas-to-liquids emissions capture and fuel conversion. The first five of these processes are proven to produce up to 125 gallons of renewable fuel per dry metric ton of feedstock (on a gasoline gallon equivalent basis, or GGE), depending on feedstock, lignin content, site conditions, and other process parameters, with extremely low carbon intensity scores of 15. The sixth step has the potential to increase bulk biomass conversion yields even further, to more than 140 GGE and more than 70% of the theoretical maximum yield from most forms of woody biomass.

Integrated Process

Comstock IP Holdings is focused on continuously improving the proven performance and operations of Comstock Fuel’s commercial refining solutions, including by increasing feedstock diversity, bulk conversion yields, and product quality for use in SAF while decreasing total variable costs.

The technologies covered by the NREL license have the proven potential to contribute to each of those objectives, including by depolymerizing and stabilizing intermediates, by reforming feedstock derived water to decrease reliance on fossil hydrogen, and by removing oxygen in a way that favors high concentrations of aromatic hydrocarbons for use in SAF.

David Winsness, President of Comstock Fuels, said, “Our existing commercial process unlocks and converts wasted, unused, and purpose grown woody biomass into renewable fuels at extraordinary yields and carbon intensities, essentially creating an endless oilwell hidden in plain sight. Our planned commercial facilities have been designed to tap into that oilwell to produce an array of intermediates and fuels. However, further developing and integrating the NREL technologies into our process could give us the remarkable additional ability to maximize aromatic content and quality specifically for high value use in addressing the recent global surge in demand for SAF.”

World Class Team

The terms of the CRADA involve a three-year scope of work to jointly develop an integrated process based on Comstock’s existing process and the NREL technologies for the solvocatalytic refining of woody biomass into aromatic SAF and other renewable fuels. Comstock will fund the research and contribute staff, equipment, and use of its pilot facility in Wisconsin. The joint work will be supported by a world class team, including Gregg Beckham, David Brandner, Mickey Stone, and Michelle Reed of NREL, Yuriy Román-Leshkov, MIT’s Robert T. Haslam Professor in Chemical Engineering, and Joshua Heyne, Director of the Bioproducts, Sciences, and Engineering Lab at Washington State University. The CRADA is anticipated to culminate in construction of a pre-commercial pilot system to validate the requirements needed to rapidly scale-up the resulting process into Comstock’s already planned 50,000 metric ton per year commercial demonstration facility.

Gregg Beckham, Senior Research Fellow for NREL, said, “An integrated process based on Comstock’s and NREL’s technologies would have remarkable potential in decarbonizing liquid fuels. Comstock’s established market leadership and commercial scale-up plans for its existing process provide an exciting opportunity to accelerate commercialization of NREL’s technology. Our respective teams from NREL and MIT are delighted to work with Comstock to scale-up this technology for low-carbon fuels and products.”

“Comstock’s mission is to enable systemic decarbonization, starting with transportation,” said Kevin Kreisler, Comstock’s chief technology officer. “Our plan to do so involves developing and commercializing highly profitable new processes that bootstrap the Earth’s natural carbon cycle while enabling stakeholders at all levels of the mobility supply chain to produce and use enough renewable fuels to decarbonize at globally meaningful scales. Our existing commercial process launches that effort, but we believe that we can maximize the breadth and rate of global market adoption with continued innovation to produce the world’s first 100% renewable SAF at costs that approach parity with fossil fuels. We believe that feat to be achievable by integrating Comstock’s and NREL’s technologies, and we’re excited to get to work.”

The ELA provides Comstock IP Holdings with the exclusive worldwide right to use the NREL technologies in the processing and conversion of seed plants to renewable fuels and renewable fuel feedstocks, including native, hybrid, and transgenic phenotypes, and derivatives thereof, excluding switchgrass, big bluestem, miscanthus, and the leaves, stalks, and husks produced during the harvesting of corn, subject to limited geographic restrictions, in exchange for royalty and other fees linked to sales of licensed products and sublicensing.

NREL’s and MIT’s prior work on the NREL technologies was initially funded by the Center for Bioenergy Innovation, a DOE Research Center supported by the Office of Biological and Environmental Research in the DOE Office of Science, and the DOE Bioenergy Technologies Office on the Lignin Conversion to Sustainable Aviation Fuel Blendstocks project. More information on the technologies is available online in the articles titled Catalytic Process With Lignin Could Enable 100% Sustainable Aviation Fuel, Making Aviation Fuel from Biomass, and Continuous Hydrodeoxygenation of Lignin to Jet-Range Aromatic Hydrocarbons.

Technology Readiness Level

Comstock uses the technology readiness scale to estimate the readiness of technology from conception to commercialization, iterating sequentially as follows: (i) TRL 1 (basic principles observed and reported); (ii) TRL 2 (technology concept and application formulated); (iii) TRL 3 (analytical and experimental proof of concept); (iv) TRL 4 (validation in laboratory environment); (v) TRL 5 (pre-pilot scale validation in relevant environment); (vi) TRL 6 (pilot prototype demonstration in relevant environment); (vii) TRL 7 (scaled-up commercial prototype in operational environment); (viii) TRL 8 (commercial system demonstration); (ix) TRL 9 (commercial maturity).

The NREL technologies covered by the Comstock license have been validated at TRL 4. The scope of work under the CRADA involves rapid validation of an integrated TRL 3 process based on Comstock’s and NREL’s technologies, followed by construction of a TRL 6 pre-commercial pilot system. Once complete, a modular TRL 7 scale-up of the integrated process would be added to Comstock’s recently announced 50,000 metric ton per year demonstration facility to provide the data required for scale-up in Comstock’s planned 1,000,000 metric ton per year commercial facilities at TRL 8.

About Comstock Inc.

Comstock Inc. (NYSE: LODE) commercializes innovative technologies that contribute to global decarbonization and the clean energy transition by efficiently converting under-utilized natural resources, primarily, woody biomass into low-carbon renewable fuels, end-of-life metal extraction and renewal, and generative AI-enabled advanced materials synthesis and mineral discovery for sustainable mining.

Monday, September 30, 2024

Tharimmune Signs Nonbinding Letter of Intent to Merge With Intract Pharma to Create Transformative Oral Biologic Therapeutics Company

 

Source:  Tharimmune, Inc. 9/30/2024

- Business combination to form a best-in-class, transformative oral biologics company
- Synergies between Tharimmune's clinical-stage assets and Intract's delivery platform to drive pipeline growth
- Merger anticipated to close in 1Q25

Tharimmune, Inc. (NASDAQ:THAR) ("Tharimmune"), a clinical-stage biotechnology company developing a portfolio of therapeutic candidates in inflammation and immunology, and Intract Pharma Ltd. ("Intract"), a biopharmaceutical company developing disruptive delivery solutions for oral biologics, announced today they have entered into a nonbinding, exclusive letter of intent ("LOI") pursuant to which Tharimmune will acquire all outstanding shares of privately-held Intract in exchange for newly issued restricted common stock.

Under the terms of the LOI, following the execution of a definitive agreement and the closing of the merger, Intract shareholders will own 49% of the total equity in the combined entity, which will be named Tharimmune, Inc., with Intract becoming a wholly owned subsidiary. The company will continue to trade on the Nasdaq Capital Market under the ticker symbol "THAR".

Tharimmune believes the merger will position the combined company to reach multiple milestones with significant value-creation potential over the next 24 months, driven by a strong clinical pipeline, a seasoned Board of Directors, a unified management team and the support of current healthcare-focused investors. Furthermore, this transaction aims to expand Tharimmune's product pipeline and reinforce its commitment to pioneering novel treatments, thereby enhancing its competitive position in the high-value, multibillion-dollar biologics market.

"We are delighted to announce this potential transaction with Intract and their groundbreaking oral biologics platform, which holds potential to revolutionize the way biologics are administered. By leveraging the cutting-edge work by their team, we are poised to deliver best-in-class therapeutic solutions designed to enhance patient outcomes and set new industry standards," said Randy Milby, CEO of Tharimmune. "This transformative step for both organizations underscore our shared commitment to innovation, and positions us at the forefront of the industry while enabling us to make a meaningful impact on patients' lives."

"Intract has steadfastly believed in the differentiated profile of targeted orally delivered antibody therapeutics and other innovative biologic modalities to benefit patients suffering from immuno-inflammatory and other chronic indications currently served only by injectable biologics," said Vipul Yadav, CEO of Intract Pharma. "We are excited about the prospect of partnering with Tharimmune, which brings high-quality resources, clinical-development expertise and a commitment to addressing immune-mediated diseases. Together, we look forward to advancing our pipeline towards the clinic in areas of high unmet need."

Beyond expanding Tharimmune's therapeutic pipeline, the proposed transaction, which is expected to close in the first quarter of 2025, is expected to create significant shareholder value by strengthening the company's competitive position in the high-value, multibillion-dollar biologics market. The transaction represents a strategic opportunity for the combined company to strengthen its position in the biotechnology industry, expand its therapeutic pipeline and create long-term value for shareholders.

The development of oral biologics holds immense potential to improve patient compliance and overall quality of life. By offering a more convenient and less invasive method of delivery, patients are more likely to adhere to their treatment regimens. This may, in turn, lead to better health outcomes and a higher quality of life for those who require long-term therapy with biologics. Intract's oral biologics delivery platform is designed to protect the molecules as they pass through the harsh environment of the gastrointestinal tract, ensuring they reach their target sites in the diseased tissue or in systemic circulation. This innovative approach holds potential to revolutionize the way biologics are administered, making treatments more accessible and less burdensome for patients.

On September 16, 2024, Tharimmune announced it entered into a definitive agreement with Intract Pharma to exclusively license INT-023/TH023, an oral anti-tumor necrosis factor alpha monoclonal antibody, infliximab. Under the terms of the agreement, Tharimmune licensed global development and commercialization rights (outside of South Korea) to Intract Pharma's Soteria® and Phloral® delivery platform along with an existing supply agreement for infliximab to be used in the oral product development program. That agreement is not impacted by the acquisition letter of intent.

About Intract Pharma

Intract is a biopharmaceutical company developing disruptive oral antibody delivery solutions using the Soteria® and Phloral® delivery platform to significantly improve the efficacy and safety of emerging and established protein therapeutics, as well as improve patient experience and outcomes in inflammation and immunology indications. Its platform leverages the advantage of precision targeting of large proteins and antibodies to the colon, while also protecting the biologics from enzymatic breakdown, allowing tissue/systemic uptake to create next-generation oral antibody medicines. For more information, please visit www.intractpharma.com.

About Tharimmune

Tharimmune, Inc. is a clinical-stage biotechnology company developing a portfolio of therapeutic candidates for inflammation and immunology. The Company's lead clinical-stage asset, TH104, is known to suppress chronic, debilitating pruritus or "uncontrollable itching" in PBC, a rare and orphan liver disease with no known cure. The Company's early-stage immunology pipeline includes novel multi-specific antibodies targeting unique epitopes with novel mechanisms of action against well-known, validated targets in multiple solid tumors, including PD-1, HER2 and HER3. Tharimmune has a license agreement with OmniAb, Inc. to access the company's antibody discovery technology platform against these and other specified targets.

Tharimmune Acquires Global License and Partners With Intract Pharma to Develop an Oral Formulation of Infliximab

 

Source:  Tharimmune, Inc. 9/16/2024

Tharimmune, Inc. (NASDAQ:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company developing a portfolio of therapeutic candidates in inflammation and immunology, announced today that it has entered into a definitive agreement with Intract Pharma to exclusively license INT-023/TH023, an oral anti-tumor necrosis factor-alpha (TNF-α) monoclonal antibody, infliximab. This strategic partnership aims to expand Tharimmune's therapeutic pipeline and reinforce its commitment to pioneering novel treatments for autoimmune diseases.

Under the terms of the agreement, Tharimmune licensed global development and commercialization rights (outside of South Korea) to Intract Pharma's Soteria® and Phloral® delivery platform along with an existing supply agreement for infliximab to be used in the oral product development program. Intract Pharma received an upfront payment and is eligible to receive additional payments upon an equity financing of the Company and is eligible for future development, regulatory and commercial milestones, as well as mid-single digit royalties based on net product sales. The agreement retains a right of first refusal to continue development and commercialization after a Phase 2 clinical trial. In addition, Tharimmune has the option to exercise the license to Intract's platform for up to four additional targets.

Infliximab is a purified, recombinant DNA-derived chimeric IgG monoclonal antibody protein that contains both murine and human components that inhibit TNF-α. Tumor necrosis factor-alpha is a signaling protein involved in acute phase reactions and systemic inflammation. Infliximab is sold by Janssen Biotech under the Remicade® brand for numerous indications including Crohn's disease, ulcerative colitis, rheumatoid diseases and plaque psoriasis.

Traditionally administered through intravenous infusions, oral delivery of antibodies such as infliximab is challenging due to the complexity of navigating such large molecules through the gastrointestinal tract. This new partnership aims to overcome these challenges using Intract's delivery platform, making it possible to administer infliximab in a pill form. An oral route of administration holds potential to improve patient compliance and quality of life, while also reducing the burden on the healthcare system associated with long-term intravenous therapy.

"The integration of Intract's innovative technology, combined with the high-quality infliximab monoclonal antibody provided by their existing supply agreement, holds tremendous potential to accelerate and reinforce our commitment to immunology. This new collaboration not only broadens our therapeutic focus, but also aligns with our mission to improve patient outcomes by developing more convenient and accessible treatment options," said Randy Milby, CEO of Tharimmune. "An oral form of infliximab represents a significant advancement in the treatment of chronic inflammatory diseases, and the opportunity for Tharimmune to compete in a multibillion-dollar global market."

This partnership enables the targeted delivery of antibody therapeutics directly to the colon or small intestine. By leveraging Intract's platform, Tharimmune aims to enhance the effectiveness of TNF-α inhibitors such as infliximab through precision delivery that maximizes proteolytic stabilization and tissue permeation. This novel approach offers significant potential for directly addressing inflammatory conditions within the gastrointestinal tract, including inflammatory bowel disease, as well as systemic inflammatory disorders where TNF-α plays a critical role in disease progression.

"Safer and orally available biological treatments for long term use in chronic inflammation and immune mediated diseases represents a major area of medical need for millions of patients" said Vipul Yadav, CEO of Intract. "We are delighted to be partnering with Tharimmune and bringing on board their clinical development expertise in immunology to further advance together our oral anti-TNFα antibody into the clinic".

About Intract Pharma

Intract is a biopharmaceutical company developing disruptive oral antibody delivery solutions to significantly improve the efficacy and safety of emerging and established protein therapeutics, as well as improve patient experience and outcomes in inflammation and immunology indications. Its platform leverages the advantage of precision targeting of large proteins and antibodies to the colon, while also protecting the biologics from enzymatic breakdown, allowing tissue/systemic uptake to create next-generation oral antibody medicines. For more information, please visit www.intractpharma.com

About Tharimmune

Tharimmune, Inc. is a clinical-stage biotechnology company developing a portfolio of therapeutic candidates for inflammation and immunology. The Company's lead clinical-stage asset, TH104, is known to suppress chronic, debilitating pruritus or "uncontrollable itching" in PBC, a rare and orphan liver disease with no known cure. The Company's early-stage immunology pipeline includes novel multi-specific antibodies targeting unique epitopes with novel mechanisms of action against well-known, validated targets in multiple solid tumors, including PD-1, HER2 and HER3. Tharimmune has a license agreement with OmniAb, Inc. to access the company's antibody discovery technology platform against these and other specified targets.

Saturday, September 21, 2024

BioFuse Medical Technologies Appoints Dr. David Battleman as Chief Executive Officer

 

Source:  Biofuse Medical Technologies, Inc. 3/24/2024

Proven healthcare executive and life sciences strategist joins to bring groundbreaking BioFuse Multi-Tissue Welder (MTW) technology to market

BioFuse Medical Technologies, a leading developer of radio frequency (RF) technology for surgical welding, today announced that David Battleman, MD, MBA, MSc, has been appointed as its President & Chief Executive Officer. Dr. Battleman brings a wealth of experience that strongly aligns with the company's commitment to advancing healthcare through innovative surgical solutions and will lead BioFuse through the development and launch of the company's RF surgical welding devices.

Dr. Battleman is the Principal & Founder of TrueNorth Lifesciences, a boutique life science strategic consulting and financial advisory firm, and has over 20+ years of working with highly innovative life science companies seeking to optimize and accelerate growth. Previously, Dr. Battleman served as a Senior Principal in the R&D and Commercial Strategy Practice of IMS Health Holdings, Inc. (now IQVIA; NYSE: IQV), a Fortune 500 company providing data and consulting services to the global pharmaceutical industry. Prior to joining IMS Health, he was a management consultant at Bain & Company and Sr. Director for Pfizer Pharmaceuticals. Dr. Battleman holds an MD from Weill Cornell Medical College, an MBA from the University of Pennsylvania's Wharton School of Business, and an MSc from the Harvard School of Public Health.

Dr. David Battleman's appointment as the CEO signifies a strategic advancement for BioFuse as the company positions itself at the forefront of surgical innovation. The BioFuse Board of Directors believes that Dr. Battleman's extensive experience in healthcare & life science technology development & commercialization makes him an ideal leader to guide BioFuse through its next phase of growth. Commenting on BioFuse's technology, Dr. Battleman stated, "I am excited to join BioFuse Medical Technologies at this critical juncture as the company advances its highly innovative Multi-Tissue Welding technology through late-stage development & commercialization. BioFuse MTW, as a multi-tissue welding device, has the potential to revolutionize a significant number of surgical procedures that require sutures or staples, improve patient recovery times, and address critical challenges in healthcare cost management."

Dr. Joseph Stauffer, Chairman of BioFuse Medical Technologies, expressed his enthusiasm for the new leadership, saying, "We are confident that Dr. Battleman's extensive background in healthcare, capital markets, and strategic leadership will further propel BioFuse towards achieving its mission. His appointment comes at a pivotal time for our company, and we look forward to the positive impact his expertise will have on advancing our innovative surgical solutions."

About BioFuse Medical Technologies

BioFuse Medical Technologies, Inc. is a privately held medical device company headquartered in Melbourne, Florida. The company is dedicated to the development of the BioFuse Multi-Tissue Welder (MTW), an advanced electrosurgical platform designed to transform the current surgical landscape. The MTW technology is a breakthrough in multi-tissue welding, offering a proprietary high-frequency system that outperforms traditional sutures and staples, thereby enhancing patient outcomes and reducing healthcare costs. With a strong product pipeline, clear regulatory roadmap, and a market potential of $3 billion, BioFuse Medical Technologies is positioned to revolutionize and dominate the surgical suture, staple, and electrocautery vessel sealing markets in the United States and Europe.

Keep up with BioFuse's latest advancements at www.biofusemedical.com and follow us on LinkedIn.

Investors interested in learning more about BioFuse Medical Technologies, Inc. and potential investment opportunities in the Company's 506(c) offering can visit biofusemedical.com.