Tharimmune Inc

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Tharimmune, Inc. is a clinical-stage biotechnology company developing a portfolio of therapeutic candidates for inflammation and immunology. It also develops TH104, which is known to suppress chronic, debilitating pruritus or uncontrollable itching in PBC, a rare and orphan liver disease with no known cure. The company was founded on March 28, 2017 and is headquartered in Bridgewater, NJ.

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 BRIDGEWATER, NJ / ACCESSWIRE / November 18, 2024 / 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.

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

BRIDGEWATER, NJ / ACCESSWIRE / November 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.

Tharimmune Granted European Patent for Delivery of Optimized Molecularly Targeted Therapeutics

BRIDGEWATER, NJ / ACCESSWIRE / November 4, 2024 / Tharimmune, Inc. (Nasdaq:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company developing a portfolio of therapeutic candidates in inflammation and immunology, announces that management will be participating in two upcoming conferences. Randy Milby, Chief Executive Officer, will attend the 2024 Spartan Capital Investor Conference being held on November 4, 2024 in New York and hold one-on-one meetings.

Tharimmune Announces Upcoming Conference Presentations

BRIDGEWATER, NJ / ACCESSWIRE / October 30, 2024 / Tharimmune, Inc. (NASDAQ:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company developing a portfolio of therapeutic candidates in inflammation and immunology, received positive feedback from a Scientific Advice meeting with the European Medicines Agency (EMA) that included guidance on a planned Phase 2 trial to advance TH104, the Company's lead clinical-stage candidate for moderate-to-severe pruritus in primary biliary cholangitis (PBC). The EMA interactions specifically focused on both the Phase 2 and Phase 3 clinical program of TH104.

Tharimmune Receives Positive Regulatory Feedback From EMA for TH104 Clinical Program for Chronic Pruritus in Primary Biliary Cholangitis

TH104, the Company's lead candidate for moderate-to-severe pruritus in chronic liver disease, showed no opioid withdrawal effects, reinforcing safety profile TH104 was well tolerated with no unexpected treatment-emergent adverse events, supporting further clinical development Company expects Phase 2 topline data for chronic pruritus in primary biliary cholangitis (PBC) patients in 2025 BRIDGEWATER, NJ / ACCESSWIRE / October 28, 2024 / 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 Phase 1 data at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting, underway in Philadelphia. 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).

Tharimmune Presents Favorable TH104 Phase 1 Clinical Data at the American College of Gastroenterology 2024 Annual Scientific Meeting

- 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 BRIDGEWATER, NJ and LONDON, UK / ACCESSWIRE / September 30, 2024 / 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.

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

BRIDGEWATER, NJ and LONDON, UK / ACCESSWIRE / September 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.

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

BRIDGEWATER, NJ / ACCESSWIRE / July 22, 2024 / Tharimmune, Inc . (NASDAQ:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company developing a portfolio of therapeutic candidates in inflammation and immunology, today announced the appointment of David Jones, Professor of Liver Immunology at Newcastle University in England, to its Scientific Advisory Board (SAB).

Tharimmune Appoints Prof. David Jones of Newcastle University to its Scientific Advisory Board

BRIDGEWATER, NJ / ACCESSWIRE / July 17, 2024 / Tharimmune, Inc. (Nasdaq:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company developing a portfolio of therapeutic candidates in inflammation and immunology, announces the appointment of David H. Clarke as a Strategic Advisor to the Company's executive management team.

Tharimmune Appoints Global Business Executive David H. Clarke as Key Strategic Advisor

Pharmacokinetic profile of oral transmucosal delivery of TH104 was comparable to intravenous delivery of reference drug Positive safety/tolerability achieved with TH104 reporting a mild side-effect profile Planning for Phase 2 trial for moderate-to-severe chronic pruritus in primary biliary cholangitis (PBC) is ongoing and on track to initiate in 2024 BRIDGEWATER, NJ / ACCESSWIRE / June 10, 2024 / Tharimmune, Inc. (Nasdaq:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company developing a portfolio of therapeutic candidates for inflammation and immunology, reports positive results from its Phase 1 clinical trial with TH104, a proprietary transmucosal buccal film embedded with the approved, active compound nalmefene that easily adheres inside of the mouth on the cheek and biodegrades within minutes. Results in healthy subjects demonstrated consistent pharmacokinetic (PK) profiles across buccal and intravenous routes of administration with a comparable safety and tolerability profile between routes of administration.

Tharimmune Announces Positive Results of Phase 1 Trial in Healthy Subjects with TH104, its Lead Candidate for Moderate-to-Severe Pruritus in Primary Biliary Cholangitis

Tharimmune (NASDAQ: THAR ) stock is on the move Friday as investors prepare for the company's shares to undergo a reverse split when markets close today. Tharimmune is enacting a one-for-15 reverse stock split for THAR shares.

Why Is Tharimmune (THAR) Stock Moving Today?

BRIDGEWATER, NJ / ACCESSWIRE / April 30, 2024 / Tharimmune, Inc. (NASDAQ:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company developing a portfolio of therapeutic candidates in inflammation & immunology announced that management will be participating in two investor conferences in May. Randy Milby, Chief Executive Officer, will be presenting at the Planet MicroCap Showcase: VEGAS 2024 being held at the Paris Hotel & Casino in Las Vegas, Nevada, and will hold 1x1 meetings with investors.

Tharimmune To Participate in Two Upcoming Investor Conferences in May

Obtained rights from Washington University to develop and incorporate human HER2 directed antibodies Complements early pipeline of novel tunable "Knob domain" antibodies for HER2 & HER3 BRIDGEWATER, NJ / ACCESSWIRE / April 23, 2024 / Tharimmune, Inc. (NASDAQ:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company developing a portfolio of therapeutic candidates in inflammation & immunology, announced today an option agreement for an exclusive license with Washington University in St. Louis for the rights to develop and commercialize technology related to multiple hybridomas and antibodies directed specifically towards human HER2. The technology was developed through a collaboration of multidisciplinary researchers in cancer immunology at Washington University School of Medicine.

Tharimmune Announces Option Agreement for Key Technologies for Generating HER2/HER3 Antibody Drug Conjugates (ADCs)

OmniAb Inc

Group includes leading experts in multiple disciplines including immunology, liver diseases, protein engineering, antibody drug conjugates and platform innovation BRIDGEWATER, NJ / ACCESSWIRE / April 15, 2024 / Tharimmune, Inc. (Nasdaq:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company developing a portfolio of therapeutic candidates in inflammation & immunology announced today the formation of a new Scientific Advisory Board (SAB) that includes a group of leading experts in fields spanning immunology, liver disease clinical trials, protein engineering, antibody drug conjugates as well as Knob domains, the smallest antibody like fragments. "Tharimmune's mission is to advance immunology and oncology treatments for people suffering from high unmet need conditions and help them look forward to a better tomorrow," said Randy Milby, Chief Executive Officer of Tharimmune.

Tharimmune Announces Scientific Advisory Board to Drive Clinical-Stage Lead in Chronic Liver Disease and Early-Stage Tunable Knob Domains for Generating Antibody Drug Conjugate (ADC) Biotherapeutics

Tharimmune invites individual and institutional investors as well as advisors and analysts, to attend its real-time, interactive presentation at the Emerging Growth Conference BRIDGEWATER, NJ / ACCESSWIRE / March 5, 2024 / Tharimmune, Inc. (NASDAQ:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company developing a portfolio of therapeutic candidates in inflammation & immunology is pleased to announce that it has been invited to present at the Emerging Growth Conference on March 7th, 2024 The next Emerging Growth Conference is presenting on March 7, 2024. This live, interactive online event will give existing shareholders and the investment community the opportunity to interact with the Company's Management team in real time.

Tharimmune to Present at the Emerging Growth Conference on March 7, 2024

Positive safety/tolerability profile achieved with TH104 showing self-resolving, mild side effect profile aligned with previous studies Phase 1 clinical trial compared oral transmucosal delivery of TH104 to injectable reference approved drug completed Company fully funded into 2025 with Phase 2 moderate-to-severe chronic pruritus in primary biliary cholangitis (PBC) study on-track and expected to initiate in 2024 BRIDGEWATER, NJ / ACCESSWIRE / February 20, 2024 / Tharimmune, Inc. (NASDAQ:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company developing a portfolio of therapeutic candidates for inflammation and immunology announced today the completion of the Company's Phase 1 clinical trial with TH104. TH104 is a proprietary transmucosal buccal film embedded with the approved, active compound nalmefene which easily adheres inside of the mouth on the cheek and biodegrades within minutes.

Tharimmune Announces Positive Results in Phase 1 Clinical Trial of TH104, its Lead Clinical Therapeutic Candidate

Phase 1 clinical trial dosing of first patient complete; primary objective to assess safety/tolerability and absolute bioavailability of TH104 Phase 1 study expected to be completed in 1Q24 with topline readout in 2Q24 Company fully funded into 2025 with full readouts of Phase 1 and 2 in moderate-to-severe chronic pruritus in PBC expected in 4Q24/1Q25 BRIDGEWATER, NJ / ACCESSWIRE / February 5, 2024 / Tharimmune, Inc. (NASDAQ:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company developing a portfolio of therapeutic candidates in inflammation & immunology announced today the first patient dosed in the Company's Phase 1 clinical trial with TH104, utilizing a proprietary oral thin film. TH104 is a proprietary transmucosal buccal film embedded with the approved, active compound nalmefene onto a thin film which easily adheres inside of the mouth on the cheek and biodegrades within minutes.

Tharimmune Announces Dosing of First Patient in Phase 1 Clinical Trial of TH104, its Lead Candidate for Pruritus in Primary Biliary Cholangitis

Phase 1 trial initiated to assess safety/tolerability and absolute bioavailability of TH104 with topline data expected in 2Q24 Planning well underway for Phase 2 of TH104 in primary biliary cholangitis (PBC) patients suffering from moderate-to-severe chronic pruritus Company outlines near-clinical pipeline of novel antibody technology for multiple immuno-oncology targets and plans an R&D day in 2024 Company fully funded into 2025 with full readouts of Phase 1 and Phase 2 results for moderate-to-severe chronic pruritus in PBC expected in 4Q24/1Q25 BRIDGEWATER, NJ / ACCESSWIRE / January 29, 2024 / Tharimmune, Inc. (NASDAQ:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company developing a portfolio of therapeutic candidates in inflammation & immunology announces initiation of a Phase 1 trial with TH104, utilizing a proprietary oral thin film. TH104 is a proprietary transmucosal buccal film embedded with the active compound nalmefene onto a thin film which easily adheres inside of the mouth on the cheek and biodegrades within minutes.

Tharimmune Announces Initiation of Phase 1 Clinical Trial of TH104 and Provides Business Update

Phase 1 ex-US trial in chronic liver disease patients in an open-label study showed a 33.3% decrease in 24-hour mean itching intensity score after a single dose TH104 was well tolerated with no unexpected treatment-emergent adverse events comparable to previous phase 1 studies Company funded into early 2025 and expects bridging PK data in the US and Phase 2a results for chronic pruritus in primary biliary cholangitis (PBC) in 2024 BRIDGEWATER, NJ / ACCESSWIRE / December 11, 2023 / Tharimmune, Inc. (Nasdaq:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company developing a portfolio of therapeutic candidates for rare, inflammatory, and oncologic conditions announces positive phase 1 data with TH104, a proprietary transmucosal buccal film which easily adheres to the inside of the mouth. The Phase 1 trial was a single-dose, single-center, open-label, randomized, study of TH104 transmucosal buccal film conducted in India in two different cohorts.

Tharimmune Announces Positive Topline Data with TH104, its Lead Candidate for Moderate-to-Severe Pruritus in Chronic Liver Disease Patients

BRIDGEWATER, NJ / ACCESSWIRE / November 30, 2023 / Tharimmune, Inc. (Nasdaq:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company developing a portfolio of therapeutic candidates for rare, inflammatory, and oncologic conditions, today announced the closing of its previously announced public offering of an aggregate of 11,000,000 shares of its common stock (or pre-funded warrants ("Pre-Funded Warrants") in lieu thereof), including the partial exercise of the underwriter's over-allotment option. Each share of common stock (or Pre-Funded Warrant) was sold at a public offering price of $1.00 per share (inclusive of the Pre-Funded Warrant exercise price).

Tharimmune, Inc. Announces Closing of $11 Million Public Offering

Tharimmune (THAR) announces positive data from a phase I study on TH104 and the development timeline in chronic pruritis in primary biliary cholangitis indication.

Tharimmune (THAR) Up on Positive Data From Pipeline Candidate

Tharimmune (NASDAQ: THAR ) stock is falling on Tuesday after the clinical-stage biotechnology company announced a public offering for its shares. That public offering has Tharimmune selling 10 million shares of THAR stock.

Why Is Tharimmune (THAR) Stock Down 70% Today?

BRIDGEWATER, NJ / ACCESSWIRE / November 27, 2023 / Tharimmune, Inc. (NASDAQ:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company developing a portfolio of therapeutic candidates for rare, inflammatory, and oncologic conditions, today announced the pricing of an underwritten public offering of 10,000,000 shares of common stock (or pre-funded warrants ("Pre-Funded Warrants") in lieu thereof). Each share of common stock (or Pre-Funded Warrant) is being sold at a public offering price of $1.00 per share (inclusive of the Pre-Funded Warrant exercise price) for gross proceeds of $10,000,000, before deducting underwriting discounts and offering expenses.

Tharimmune, Inc. Announces Pricing of $10 Million Public Offering

Phase 1 ex-US trial achieved primary objective of predictable pharmacokinetic profiling with favorable safety and tolerability Company expects to engage FDA on Phase 2 trial design and expects topline data in 2024 for chronic pruritis First indication for chronic pruritis in PBC where 70% of patients suffer from intractable and debilitating itching with limited treatment options BRIDGEWATER, NJ / ACCESSWIRE / November 27, 2023 / Tharimmune, Inc. (NASDAQ:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company developing a portfolio of therapeutic candidates for rare, inflammatory, and oncologic conditions announces positive phase 1 data with TH104, a proprietary transmucosal buccal film which easily adheres to the inside of the mouth. Tharimmune also announced plans on a development timeline for a Phase 2a study in chronic pruritis in primary biliary cholangitis (PBC) patients which will complement the data package the Company expects to discuss with the US FDA and European Regulatory Authorities.

Tharimmune Reports Positive Phase 1 Data on TH104, its Lead Therapeutic Candidate, for Chronic Pruritis in Primary Biliary Cholangitis (PBC)

Tharimmune (NASDAQ: THAR ) stock is falling on Monday as investors prepare for the company to enact a reverse stock split after markets close today. That reverse stock split will see the company consolidate 25 shares of THAR stock into a single share.

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