BioStem Technologies Announces Record Preliminary Fourth Quarter Net Revenue of $102.9 Million, with Full-Year 2024 Net Revenue Expected to Reach $301.8 Million

 

Source:  BioStem Technologies, Inc. 1/13/2025

BioStem Technologies, Inc. (OTC: BSEM) (“BioStem”, “we”, “us”, or “our”), a leading MedTech company focused on the development, manufacturing, and commercialization of placental-derived products for advanced wound care, today announced selected preliminary financial results for the fiscal fourth quarter and full year ended December 31, 2024.

2024 Preliminary Fourth Quarter and Year End Results:

• Fourth quarter net revenue is expected to be approximately $102.9 million, which represents a 794% increase over the fourth quarter of 2023, driven by solid performance across the product portfolio.

• Full-year 2024 net revenue is expected to be approximately $301.8 million, up from $16.7 million for fiscal year 2023, reflecting an increase of $285.1 million, or 1,702%.

• Fourth quarter gross profit is expected to be approximately $99.3 million, compared to $10.9 million for the fourth quarter of 2023, which represents an 811% increase.

• Full-year 2024 gross profit is expected to be approximately $288.1 million, compared to $15.4 million for fiscal year 2023, which represents an 1,775% increase.

• This exceptional year-over-year growth reflects the robust adoption of AmnioWrap2 OneView™ in the post-acute care market and the successful introduction of Vendaje AC®, supported by the targeted commercial strategies of Venture Medical, LLC (“Venture”), BioStem’s exclusive sales and marketing partner. Leveraging the advanced analytics and market insights provided by the Venture OneView™ platform, BioStem has effectively expanded its market presence, driving accelerated product adoption and strengthening its position as a leader in advanced wound care solutions.
  

“2024 has been an extraordinary and transformative year for BioStem, defined by record-breaking growth and a series of groundbreaking milestones that underscore our leadership in advanced wound care," said Jason Matuszewski, Chief Executive Officer of BioStem. “Achieving over 1,700% year-over-year revenue growth is a testament to the relentless execution of our strategic initiatives, the innovation behind our products like AmnioWrap2™ and the newly-launched Vendaje AC®, and the dedication of our team.

Our success has been further catalyzed by our valued partnership with Venture and their state-of-the-art Venture OneView™ platform, which has revolutionized our distribution capabilities, enhanced visibility within the market, and accelerated product adoption. This synergy exemplifies the power of collaboration in driving impactful results.

As we look to 2025, I am energized by the opportunities ahead, particularly the anticipated finalization of the LOI with ProgenaCare, a key step in broadening our product portfolio and deepening our impact across the continuum of wound care. Coupled with our investments in R&D, clinical trials, and the expansion of our world-class team, we believe this acquisition positions us to continue delivering cutting-edge solutions that improve patient outcomes and create lasting value for all stakeholders.

We are deeply grateful for the unwavering support of our shareholders, customers, and partners, and we remain committed to leveraging innovation, collaboration, and excellence to shape the future of wound care and beyond.”

About BioREtain^®:
BioStem’s placental allografts are processed utilizing BioStem’s proprietary BioREtain^®method, which preserves the tissue’s endogenous biological properties while maintaining the structure and matrix found in fresh perinatal tissue. The patented six-step BioREtain^®process is gentle, minimally invasive, and preserves the natural integrity of the amniotic tissue/components critical to the wound treatment process. For a full overview of BioREtain, please visit: https://biostemtechnologies.com/our-science/#six-steps.

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About BioStem Technologies, Inc. (OTC: BSEM):
BioStem Technologies is a leading innovator focused on harnessing the natural properties of perinatal tissue in the development, manufacture, and commercialization of allografts. BioStem is focused on manufacturing products that change lives, leveraging its proprietary BioREtain^® processing method. BioREtain^® has been developed by applying the latest research in advanced wound care, focused on maintaining growth factors and preserving tissue structure. BioStem Technologies’ quality management system and standard operating procedures have been reviewed and accredited by the American Association of Tissue Banks (“AATB”). These systems and procedures are established per current Good Tissue Practices (“cGTP”) and current Good Manufacturing Processes (“cGMP”). Our portfolio of quality brands includes AmnioWrap2™, VENDAJE^®, VENDAJE AC^®, and VENDAJE OPTIC^®. Each BioStem Technologies placental allograft is processed at BioStem’s FDA registered and AATB accredited site in Pompano Beach, Florida. For more information visit biostemtechnologies.com and follow us on Twitter and LinkedIn.

 

BioStem Announces Notice of Allowance for U.S. Patent Application for Sterile Human Placental Allografts

 

Source:  BioStem Technologies, Inc. 11/25/2024

Company continues to advance its placental-derived product portfolio with the first patent granted in the fenestrated wound care market

BioStem Technologies, Inc. (OTC: BSEM), a leading MedTech company focused on the development, manufacturing, and commercialization of placental-derived products for advanced wound care, today announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for BioStem’s patent application No. 18/591,883 for STERILE HUMAN PLACENTAL ALLOGRAFTS HAVING A PLURALITY OF SLITS, OPENINGS, AND/OR FENESTRATIONS FORMED THEREON. The patent application will grant as U.S. Patent No. 12,144,831 on November 19, 2024.

This patent will be used in the development of novel placental allografts designed for advanced wound care using BioStem’s BioREtain^® process, which preserves essential natural factors. The allografts using this technology will feature flaps that open to allow exudate to escape without sacrificing surface area, making them suitable for both acute and chronic wound settings. This technology is unique, as there are no other fenestrated allografts on the market that offer the same benefits.

Jason Matuszewski, Chief Executive Officer of BioStem, stated: “BioStem continues to drive innovation in the wound care space, and we are pleased to enhance our intellectual property portfolio with the issuance of this significant patent. This is the first and only patent granted for use in tabular fenestrated allografts, which will support our commercial efforts and expands our IP portfolio. With 27 patents pending and 42 issued, BioStem has a strong portfolio across the wound care landscape that will protect the company as we advance in the market.”

A product using this technology is under development and is currently not commercially available and will be introduced using the HCT/P regulatory pathway. Once developed, the new allografts could be used as a protective covering for exudating wounds across the acute or chronic setting.

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About BioStem Technologies, Inc. (OTC: BSEM):
BioStem Technologies is a leading innovator focused on harnessing the natural properties of perinatal tissue in the development, manufacture, and commercialization of allografts. The Company is focused on manufacturing products that change lives, leveraging its proprietary BioREtain^® processing method. BioREtain^® has been developed by applying the latest research in advanced wound care, focused on maintaining growth factors and preserving tissue structure. BioStem Technologies’ quality management system and standard operating procedures have been reviewed and accredited by the American Association of Tissue Banks (“AATB”). These systems and procedures are established per current Good Tissue Practices (“cGTP”) and current Good Manufacturing Processes (“cGMP”). Our portfolio of quality brands includes AmnioWrap²™, VENDAJE^®, VENDAJE AC^®, and VENDAJE OPTIC^®. Each BioStem Technologies placental allograft is processed at the Company’s FDA registered and AATB accredited site in Pompano Beach, Florida.

 

BioStem Technologies Signs Letter of Intent to Acquire Wound Care Products and Technologies from ProgenaCare Global

 

Source:  BioStem Technologies, Inc. 11/20/2024

 Additions of ProgenaMatrix® and revyve™ Antimicrobial Wound Gel part of planned expansion of BioStem’s commercial product portfolio

BioStem Technologies Inc. (OTC: BSEM), a leading MedTech company focused on the development, manufacture, and commercialization of placental-derived biologics, today announced the signing of a Letter of Intent (LOI) to acquire commercial-stage products and development technologies from ProgenaCare Global LLC (“ProgenaCare”), a pioneering medical device company leveraging cutting-edge advances in biomaterials to provide effective, affordable advanced wound care solutions. The acquisition of ProgenaMatrix and revyve Antimicrobial Wound Gel reflects the Company’s continued commitment to building a diverse portfolio of complementary wound care products that enable BioStem to leverage its commercial infrastructure.

BioStem expects to finalize definitive agreements within 60 days following customary due diligence. The transaction is subject to regulatory approvals and Board consent. BioStem and ProgenaCare will work together to integrate ProgenaCare’s products into BioStem’s portfolio.

Jason Matuszewski, CEO of BioStem, stated: “ProgenaCare represents a significant opportunity for us as part of our portfolio expansion initiatives. The products align perfectly with our goal to provide wound-care solutions across the entire continuum of care. The addition of ProgenaCare’s 510(k) cleared products will enhance our position in the hospital-based segments of the market, while ProgenaCare’s proprietary technology platforms and product pipeline offer significant opportunities for us to help drive future growth. With revyve, we could address wounds early in the treatment continuum, greatly broadening the patient population BioStem supports and offering multiple opportunities for channel expansion. We believe this acquisition will not only strengthen our existing commercial activities but also position ProgenaCare for accelerated growth and operational efficiency. This partnership will enable both of our organizations to unlock new potential, fostering talent and innovation to deliver meaningful wound care solutions.”

Howard Wathall, CEO of ProgenaCare, stated: “We believe that joining the BioStem family will significantly enhance the value of ProgenaCare’s products and provide a strong platform for expansion in the growing active and advanced healing segments. This partnership not only promises improved growth prospects and enhanced product development capabilities but also operational efficiencies that will benefit both organizations. We are particularly optimistic about the potential of our keratin protein and hydrogel product pipelines and are confident that BioStem’s experience and resources will help us finalize development and achieve commercial success. Together, we are poised to make a meaningful impact in the wound care market.”

ProgenaCare Product Portfolio:
ProgenaCare’s innovative approach to wound care leverages scientific advancements in biomaterials to deliver effective products for a range of wound types, from acute injuries to chronic conditions. The company’s proprietary human keratin technology supports the body’s natural healing processes, making ProgenaMatrix an invaluable asset in the wound care market. Revyve is a premium hydrogel that provides scientifically proven efficacy in an easy-to-use thermo-reversible pluronic gel.

ProgenaCare’s portfolio includes:

ProgenaMatrix:
ProgenaCare’s flagship product, ProgenaMatrix, is the first and only commercially available human keratin matrix for wound care. Constructed from robust and degradation resistant human keratin protein, ProgenaMatrix is a hydrated, non-cellular biomaterial that supports the body’s natural healing processes. Keratin protein has been shown to activate keratinocytes and fibroblasts, modulating the response to injury and offering clinicians a unique solution for complex wounds.

This advanced wound care solution is FDA 510(k) cleared for a broad range of indications, including:

• Venous stasis ulcers
• Diabetic foot ulcers
• Pressure ulcers
• Partial-thickness burns
• Surgical wounds
• Donor sites and grafts

To learn more about ProgenaMatrix, visit HERE

revyve:
revyve is a premium hydrogel that combines Kane Biotech’s patented coactiv+™ technology with PHMB, resulting in a thermo-reversible gel that is easy to apply. This innovative product creates a moist environment ideal for wound healing and provides broad-spectrum antimicrobial activity. Indicated for various wound types, revyve is effective for:

• Diabetic foot ulcers
• Leg ulcers
• Pressure ulcers
• 1st and 2nd degree burns
• Partial and full thickness wounds
• Large surface area wounds
• Surgical incisions
  

To learn more about revyve, visit HERE

Join BioStem’s Distribution List & Social Media:
To follow the latest developments at BioStem, sign-up for the Company’s email distribution list HERE, and follow us on Twitter and LinkedIn.

About BioStem Technologies:
BioStem Technologies is a leading innovator focused on harnessing the natural properties of perinatal tissue in the development, manufacture, and commercialization of allografts for regenerative therapies. The Company is focused on manufacturing products that change lives, leveraging its proprietary BioREtain ^® processing method. BioREtain ^® has been developed by applying the latest research in regenerative medicine, focused on maintaining growth factors and preserving tissue structure. BioStem Technologies’ quality management system and standard operating procedures have been reviewed and accredited by the American Association of Tissue Banks (“AATB”). These systems and procedures are established per current Good Tissue Practices (“cGTP”) and current Good Manufacturing Processes (“cGMP”). Our portfolio of quality brands includes AmnioWrap ² ™, VENDAJE ^® , VENDAJE AC ^® , and VENDAJE OPTIC ^® . Each BioStem Technologies placental allograft is processed at the Company’s FDA registered and AATB accredited site in Pompano Beach, Florida.

 

Tharimmune Announces Phase 2 Study Plan for TH104 in Patients With Moderate-to-Severe Pruritus Associated With Primary Biliary Cholangitis and Provides a Business Update

 

Source:  Tharimmune, Inc. 12/16/2024

Tharimmune, Inc. (Nasdaq:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company committed to pioneering therapies in immunology and inflammation, today announced plans for initiating a Phase 2 study evaluating TH104 in patients suffering from moderate-to-severe pruritus (severe itching) associated with primary biliary cholangitis (PBC), a rare and chronic liver disease, and also provided a corporate update. The launch of this clinical trial, expected in 2025, follows favorable results from Tharimmune's Phase 1 study with TH104, recent regulatory feedback from the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), as well as progress on manufacturing clinical study supply.

Business Update and 2024 Corporate Highlights

Throughout 2024 Tharimmune achieved significant milestones across three key areas. These accomplishments reflect progress in advancing innovative therapies in inflammation and immunology, with a focus on improving patient outcomes in areas of high unmet need.

Manufacturing, Clinical and Regulatory Progress

• Validation and batches of manufacturing supply of TH104 for Phase 2 clinical study are on track for year-end.

• Announced positive results from a Phase 1 clinical trial of TH104 in healthy subjects, demonstrating a favorable pharmacokinetic profile and a mild side-effect profile.

• Received positive regulatory feedback from the FDA and EMA for the TH104 clinical program, providing guidance on the Phase 2 trial design.

• Granted a patent from the European Patent Office covering therapeutics created for carrying antibody and peptide therapies, representing a novel solution and addressing critical challenges with stability and absorption.

Medical and Scientific Community Engagement

• Participated in key industry conferences to present new clinical data and engage with the scientific community.

• Presented favorable clinical data at the American College of Gastroenterology (ACG) Annual Scientific Meeting, reinforcing the safety profile of TH104 with no unexpected treatment-emergent adverse events.

• Shared positive clinical data at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting^®, highlighting a significant correlation between blood levels and symptom relief in patients treated with TH104.

Corporate Achievements

• Entered into a licensing agreement with Intract Pharma, aiming to expand Tharimmune's product pipeline to develop oral biologics including an oral formulation of infliximab.

• Entered into a licensing agreement with OmniAb, accessing their antibody discovery technology platform to enhance Tharimmune's early-stage immunology pipeline.

• Appointed David Jones, Professor of Liver Immunology at Newcastle University in England and renowned scientist with extensive expertise in hepatic pathologies and PBC, to Tharimmune's Scientific Advisory Board.

• Completed private placement financings, raising more than $4 million to support clinical development and working capital, including TH104 development program.

TH104 Phase 2 Clinical Study

The multicenter, randomized, double-blind, placebo-controlled Phase 2 trial is designed to assess the safety, tolerability and efficacy of TH104 in reducing itch in PBC patients with moderate-to-severe pruritus, a condition that significantly impacts daily lives and remains an area of unmet medical need. The study plans to enroll approximately 40 patients at sites in the U.S., Europe and the UK. Patients will receive escalating doses of TH104 in a nine-week study that includes treatment and observation periods, with efficacy measured by changes in patient-reported itch scores utilizing the Worst-Itch Numerical Rating Scale (WI-NRS), a relevant clinical outcome assessment for pruritus, as well as other quality-of-life metrics. Additional information on the Phase 2 study is available on ClinicalTrials.gov (NCT06733519).

"Following feedback from global regulators including guidance on a future Phase 3 program, we are delighted to advance TH104 into this Phase 2 clinical trial planned for 2025, marking a critical milestone in our efforts to address the debilitating effects of chronic pruritus. Our focus on innovative delivery mechanisms that target the opioid receptors involved in the body's itch circuitry underscores the favorable data collected thus far in clinical development. We plan to report preliminary results from this Phase 2 trial in late 2025," said Randy Milby, Chairman and CEO of Tharimmune.

Board of Directors Expansion

Additionally, Tharimmune announced the appointment of Sanam Parikh to its Board of Directors, expanding the size of its Board to six Directors. Mr. Parikh brings to Tharimmune significant experience in clinical trial management, regulatory submissions and operational oversight.

Mr. Parikh has managed clinical studies across various global sites, overseeing CRO partnerships and site management to ensure compliance with complex regulatory standards. His experience includes site feasibility, budget negotiation, contract management and regulatory interactions, with particular expertise working under FDA and EMA guidelines. Earlier in his career, Mr. Parikh was an associate clinical project manager in oncology at Clario, and held various research laboratory positions prior to that.

"Sanam is an emerging leader in preclinical and clinical study management. His background in oncology-focused clinical operations along with a proven record in managing critical aspects of trial execution will significantly bolster our capabilities," added Mr. Milby. "Furthermore, his in-depth knowledge of clinical operations and his focus on ensuring study integrity from preclinical work through to regulatory submissions aligns with our strategic goals as we continue to develop and validate our oncology-focused product pipeline."

Mr. Parikh holds a Master's in Public Health with a focus on Urban Public Health from Rutgers University, and a Bachelor's in Biology from the New Jersey Institute of Technology.

About TH104

TH104 is embedded with nalmefene onto a proprietary transdermal buccal film that easily adheres to the inside of the mouth. This endows TH104 with key features making it an ideal product candidate for multiple liver-related and other pruritogenic inflammatory conditions. The molecule has a dual mechanism of action affecting both the µ-opioid receptor and the kappa-opioid receptor, as well as potentially inhibiting IL-17 inflammatory cytokine expression. These opioid receptors when stimulated and/or inhibited by the body's natural ligands have been known to be involved in the body's itch circuitry.

About Pruritus and Primary Biliary Cholangitis

According to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health, PBC is a rare and chronic disease where the bile ducts in the liver eventually become dysfunctional and cause the buildup of bile, resulting in liver damage. Pruritus is a common condition associated with PBC, affecting up to 75% of individuals at some point during their disease course. It has a debilitating impact on health-related quality of life with limited treatment options.Published survey data of PBC respondents suffering from pruritus described their itch as "bugs crawling under the skin." More than 65% of patients reported that the itch was worse at night, known as nocturnal pruritus, a high unmet need.

About Tharimmune

Tharimmune, Inc. is a clinical-stage biotechnology company developing a diverse portfolio of therapeutic candidates in immunology, inflammation and oncology. Its lead clinical asset, TH104, aims to suppress chronic pruritus associated with primary biliary cholangitis (PBC), a rare autoimmune liver disease with no known cure. The expanded pipeline includes TH023, an oral TNF-alpha inhibitor, offering a new approach to treating autoimmune diseases. Tharimmune is also advancing early-stage multi-specific biologics targeting unique epitopes against multiple solid tumors. The company has a license agreement with OmniAb, Inc. to access their antibody discovery technology for targeting specified disease markers.

Tharimmune Presents Positive Clinical Data at AASLD the Liver Meeting(R) to Support TH104 for Chronic Pruritus in Chronic Liver Disease

 

Source:  Tharimmune, Inc. 11/18/2024

Significant correlation shown between blood levels and symptom relief; TH104 was well tolerated with no unexpected treatment-emergent adverse events

Phase 2 preliminary data for chronic pruritus in primary biliary cholangitis expected in 2025

Tharimmune, Inc. (Nasdaq:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company developing a portfolio of therapeutic candidates in inflammation and immunology, presented new TH104 clinical data at the American Association for the Study of Liver Disease (AASLD) The Liver Meeting^® 2024, underway in San Diego from November 15-19. The Phase 1 trial was a single-dose, single-center, open-label, randomized study of TH104 transmucosal buccal film conducted in two cohorts of patients with chronic liver disease (CLD), with the primary outcome of safety and tolerability.

"This presentation at The Liver Meeting expands the audience for encouraging Phase 1 data with our lead candidate TH104," said Randy Milby, CEO of Tharimmune. "We look forward to initiating a Phase 2 multiple-ascending dose trial in the coming months to evaluate TH104 in chronic pruritus in primary biliary cholangitis (PBC) patients, with topline data expected in 2025. In the meantime, we continue to engage with both U.S. and EU regulatory authorities."

Data presented at The Liver Meeting include adverse events (AEs) as well as an assessment of patients' relief of pruritus symptom scores when correlated to pharmacokinetics (PK) of TH104. Patients with cholestatic liver disease and a known history of persistent generalized pruritus for at least 4 weeks prior to screening were included. After an overnight fast of 10 hours, subjects received a single low dose of TH104. Serial blood samples for PK analysis were taken, and patients were monitored for itch severity scores utilizing the Worst-Itch Numerical Rating Scale (WI-NRS), a relevant clinical outcome assessment for pruritus in chronic liver disease, and for itch intensity over a 24-hour period.

Pruritus is common in most liver diseases and the WI-NRS is a validated numerical rating scale displaying 11 numbers ranging from 0, representing "no itch," to 10, representing "worst imaginable itch," and patients are asked to pick the number corresponding to the intensity of their pruritus. Results from multiple large studies support the usefulness and validity of WI-NRS for evaluating change over time in clinical trials. Pearson's correlation coefficient (r) was used to assess the correlation between TH104 concentration (ng/ml) Area Under the Curve (AUC) and the change in WI-NRS score 48 hours after dosing.

This study screened 19 patients and 12 were enrolled with two types of CLD categorized as Child-Pugh A (cohort A) and Child-Pugh B (cohort B). The Child-Pugh score is a system for assessing the prognosis and necessity of transplant in CLD that provides a forecast of the increasing severity of a patient's liver disease and expected survival rate. The score is determined by scoring clinical measures of liver disease and the possibility of eventual liver failure, with Class A indicating mild liver disease and Class B indicating moderate liver disease with one-to-five-year survival rates of 95% and 75%, respectively. There were no patients enrolled in this study with the most severe Child-Pugh C classification.

The correlation coefficient between TH104 AUC and change in itch, r, was 0.7060, with a p-value of 0.0103 and a 95% confidence interval for r of 0.2220 to 0.9108.

Change in Itch Score vs. Pharmacokinetics of TH104

The mean baseline WI-NRS scores in Groups A and B were 4.33 and 6.17, respectively, translating to moderate-to-severe chronic pruritus at the start of the study. The mean baseline itch score for all 12 subjects was 5.25. At one-hour post-dosing with TH104, Group A and Group B had a mean decline in WI-NRS scores of 26.8% and 19.0%, respectively, and continued to decline two hours post-dose by 42.3% and 21.7%, respectively. Both cohorts continued to improve in mean itch scores at the four-hour and eight-hour time points, including the combined total subjects. At 24-hours post dosing, Group A and Group B achieved a mean decline of 30.7% and 35.2%, respectively, in pruritus scores. The mean reduction in itch scores for all 12 subjects 24 hours after a single dose of TH104 was 33.3%.

WI-NRS score over time

A total of two AEs (headache) were reported in two subjects over the course of the study. These AEs were mild and possibly related to study drug, with no serious adverse events reported. There were no deaths or other significant adverse events reported during the entire study. There were no new adverse events during the study, with events correlated with previous studies and a safety profile consistent with the literature for the active ingredient in TH104.

About TH104

TH104 is embedded with nalmefene onto a proprietary transdermal buccal film that easily adheres to the inside of the mouth. This endows TH104 with key features making it an ideal product candidate for multiple liver-related and other pruritogenic inflammatory conditions. The molecule has a dual mechanism of action affecting both the µ-opioid receptor and the kappa-opioid receptor, as well as potentially inhibiting IL-17 inflammatory cytokine expression. These opioid receptors when stimulated and/or inhibited by the body's natural ligands have been known to be involved in the body's itch circuitry.

About Pruritus and Primary Biliary Cholangitis

According to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health, PBC is a chronic disease where the bile ducts in the liver eventually become dysfunctional and cause the buildup of bile, resulting in liver damage. The disease, believed to be an autoimmune condition, affects an estimated 58 out of every 100,000 U.S. women and about 15 out of every 100,000 U.S. men. Pruritus is one of the most common conditions associated with PBC, affecting up to 75% of individuals at some point during their disease course. It has a negative impact on health-related quality of life with limited treatment options.Published survey data of PBC respondents suffering from pruritus described their itch as "bugs crawling under the skin." More than 65% of patients reported that the itch was worse at night, known as nocturnal pruritus, a high unmet need.

About Tharimmune

Tharimmune, Inc. is a clinical-stage biotechnology company developing a diverse portfolio of therapeutic candidates in immunology, inflammation and oncology. Its lead clinical asset, TH104, aims to suppress chronic pruritus associated with primary biliary cholangitis (PBC), a rare autoimmune liver disease with no known cure. The expanded pipeline includes TH023, an oral TNF-alpha inhibitor, offering a new approach to treating autoimmune diseases. Tharimmune is also advancing early-stage multi-specific biologics targeting unique epitopes against multiple solid tumors. The company has a license agreement with OmniAb, Inc. to access their antibody discovery technology for targeting specified disease markers.

Tharimmune Granted European Patent for Delivery of Optimized Molecularly Targeted Therapeutics

 

Source:  Tharimmune, Inc. 11/13/2024

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 the European Patent Office intends to grant the Company a patent covering biodegradable polymeric nanoparticles created for carrying therapeutic and targeting agents. With particular utility in cancer therapies, this innovative platform is designed to enhance the delivery of therapeutic antibodies and peptides, which are often limited by enzymatic degradation and poor systemic circulation.

The patent covers the design, preparation and therapeutic application of nanoparticles formed from biodegradable block copolymers. These nanoparticles exhibit tunable size, non-toxic profiles and the ability to prolong drug half-life in the bloodstream. By penetrating biological barriers and delivering encapsulated drug directly to disease sites, reduces systemic side effects and toxicity while improving the therapy's effectiveness. An application for a comparable U.S. patent has been submitted to the United States Patent and Trademark Office, and is currently under review.

"Molecularly targeted therapies are effective alternatives to conventional treatments, but challenges remain in delivering these antibody-based and peptide drugs. We believe our system represents a novel solution, addressing critical challenges with stability and absorption," said Randy Milby, Chief Executive Officer of Tharimmune. "We believe the platform can become an important component of future therapies, and receipt of this European patent marks an exciting first step."

This new patent complements Tharimmune's existing pipeline, including colonic targeting developed through the Company's partnership with Intract Pharma. While Tharimmune initially focused on tablet-based solutions for lower gastrointestinal delivery, this new intellectual property represents a potential platform to complement its growing pipeline. Tharimmune is also actively exploring strategic partnerships with companies that specialize in antibody conjugation to further enhance the targeting capabilities of its platform.

About Tharimmune

Tharimmune, Inc. is a clinical-stage biotechnology company developing a diverse portfolio of therapeutic candidates in immunology and inflammation. The lead clinical asset, TH104, aims to suppress chronic pruritus associated with primary biliary cholangitis (PBC), a rare autoimmune liver disease with no known cure. The expanded pipeline includes TH023, an oral TNF-alpha inhibitor, offering a new approach to autoimmune diseases. Tharimmune is also advancing early-stage multi-specific biologics targeting unique epitopes against multiple solid tumors. The company has a license agreement with OmniAb, Inc. to access their antibody discovery technology for targeting specified disease markers.

Tharimmune Announces $2.02 Million Private Placement to Advance Development Programs

 

Source:  Tharimmune, Inc.  12/6/2024

Tharimmune, Inc. (Nasdaq:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company committed to pioneering therapies in immunology and inflammation, today announced it has entered into a securities purchase agreement to raise gross proceeds of approximately $2.02 million through a private placement.

The agreement includes the issuance of 961,446 shares of common stock (or common stock equivalents) and warrants to purchase up to an additional 480,723 shares of common stock. Each share (or common stock equivalent) is priced at $2.10 and is accompanied by a warrant. The warrants will have an exercise price of $2.031 per share, becoming exercisable six months after issuance and expiring five and one-half years from the date of issuance. The closing of this transaction is expected on or about December 9, 2024, subject to customary closing conditions.

Strategic Investors and Placement Details

The financing was led by Gravitas Capital and SDS Capital Group, alongside other biotechnology-focused private investors. President Street Global served as the exclusive placement agent for the offering, ensuring seamless execution of the transaction.

After deducting placement agent fees and other offering-related expenses, the Company intends to allocate the net proceeds toward clinical development, including advancing its flagship TH104 development program, as well as general working capital.

Advancing Innovation in Biotechnology

This financing reinforces Tharimmune's commitment to advancing its portfolio of therapeutic candidates. TH104, the Company's lead clinical asset, is designed to address chronic pruritus associated with primary biliary cholangitis (PBC), a rare and challenging autoimmune liver disease.

Regulatory Details

The securities in this private placement were offered under Section 4(a)(2) of the Securities Act of 1933, as amended, and Regulation D thereunder. The shares of common stock and underlying warrants are not registered under the Securities Act or state securities laws. The Company has agreed to file a resale registration statement covering these securities to enable their future trading upon registration or qualification under applicable laws.

About Tharimmune

Tharimmune, Inc. is a clinical-stage biotechnology company focused on developing innovative therapies in immunology, inflammation, and oncology. The Company's lead product candidate, TH104, leverages a unique transdermal buccal film technology designed to address inflammatory conditions, including pruritus associated with PBC. Tharimmune is also advancing TH023, an oral TNF-alpha inhibitor, and exploring novel multi-specific biologics targeting solid tumors. Through a licensing agreement with OmniAb, Inc., the Company harnesses cutting-edge antibody discovery platforms to target specified disease markers.