Tharimmune, Inc. (NASDAQ:THAR) is a clinical-stage biotechnology company developing a diverse portfolio of therapeutic candidates focused on addressing unmet needs in immunology and inflammation. With a strong commitment to innovation, Tharimmune is leveraging its expertise to transform the lives of patients suffering from debilitating conditions.
Business Overview and History
Tharimmune, Inc. was incorporated on March 28, 2017, as a Delaware C-corporation, initially operating under the name Hillstream BioPharma, Inc. The company’s founding vision was to develop novel therapies for rare, inflammatory, and oncologic conditions with high unmet need.
In 2019, Tharimmune made a strategic move to expand its portfolio by acquiring a series of small molecule analogues through an Asset Purchase Agreement. This acquisition required an initial payment of $50,000 upon raising at least $2 million in funding, with the potential for up to approximately $1.75 million in additional milestone-based payments.
The year 2023 marked significant progress for Tharimmune in terms of partnerships and collaborations. The company entered into a research collaboration and product license agreement with Minotaur Therapeutics, Inc. and a commercial license agreement with Taurus Biosciences, LLC. These partnerships aimed to advance Picobodies against novel, unreachable, and undruggable epitopes in high-value validated targets, starting with PD-1.
In July 2023, Tharimmune further expanded its research capabilities by entering into a Research and Development Collaboration and License Agreement with Applied Biomedical Science Institute (ABSI). This agreement granted the company an exclusive, royalty-bearing, sublicensable license to develop and commercialize ABSI products targeting the ErB2 (HER2) and ErbB3 (HER3) receptors.
November 2023 saw Tharimmune entering into the Avior Patent License Agreement with Avior, which granted the company an exclusive sublicensable right and license to develop, manufacture, and commercialize certain products. This agreement included upfront license fees, milestone payments, and royalties on net sales, further strengthening Tharimmune’s intellectual property portfolio and development capabilities.
In February 2023, Tharimmune received FDA approval for an Investigational New Drug (IND) application for its lead candidate, TH104, a dual-mechanism therapy targeting chronic, debilitating pruritus or uncontrollable itching. The company plans to first seek approval for the treatment of moderate-to-severe chronic pruritus in patients with primary biliary cholangitis (PBC), an orphan liver disease in which more than 70% of patients suffer from this debilitating symptom.
In September 2024, Tharimmune further strengthened its pipeline by exclusively licensing INT-023/TH023, an oral anti-tumor necrosis factor-alpha (TNF-α) monoclonal antibody, infliximab, from Intract Pharma. This strategic partnership aims to expand Tharimmune’s therapeutic reach and reinforce its commitment to pioneering novel treatments for autoimmune diseases.
Tharimmune’s early-stage pipeline also includes novel therapeutic candidates targeting validated high-value immuno-oncology (IO) targets, such as human epidermal growth factor receptor 2 (HER2), human epidermal growth factor receptor 3 (HER3), and programmed cell death protein 1 (PD-1). The company is developing a range of antibody formats, including bispecific antibodies, antibody drug conjugates (ADCs), and small molecular weight bovine-derived “Picobodies,” which have the potential to target and bind more tightly to undruggable epitopes compared to full-sized antibodies.
In June 2024, Tharimmune entered into a nonbinding, exclusive letter of intent to acquire all outstanding shares of privately-held Intract Pharma, a biopharmaceutical company developing disruptive delivery solutions for oral biologics. This proposed merger is anticipated to close in the first quarter of 2025 and is expected to form a best-in-class, transformative oral biologics company, with synergies between Tharimmune’s clinical-stage assets and Intract’s delivery platform driving pipeline growth.
Financial Snapshot
As a clinical-stage biotechnology company, Tharimmune has not yet generated any revenue, as its focus has been on advancing its diverse pipeline of therapeutic candidates. The company reported an annual net loss of $9.32 million in 2023, with an accumulated deficit of $33.08 million as of September 30, 2024.
For the three months ended September 30, 2024, Tharimmune reported a net loss of $3.80 million, compared to a net loss of $1.82 million in the same period of the prior year. The increase in net loss was primarily driven by a $1.79 million rise in research and development expenses, largely due to increased clinical trial costs, license fees, and pre-clinical expenses. General and administrative expenses also increased by $0.23 million, mainly due to higher personnel costs, investor relations activities, and professional fees.
Tharimmune has primarily financed its operations through public and private offerings of its equity securities. In 2023, the company received net proceeds of approximately $2.1 million from a public offering in May and $9.7 million from a public offering in November. Additionally, in June 2024, Tharimmune closed a private placement offering with certain accredited investors, raising net proceeds of approximately $1.8 million.
Liquidity
The company’s cash position as of September 30, 2024, was $4.77 million, compared to $10.94 million as of December 31, 2023. Tharimmune’s management has concluded that the prevailing conditions and ongoing liquidity risks faced raise substantial doubt about the company’s ability to continue as a going concern for at least one year following the date of the latest financial statements.
As of September 30, 2024, Tharimmune’s current ratio and quick ratio were both 2.35, indicating that the company has sufficient short-term assets to cover its short-term liabilities. However, given the company’s limited operating history, recurring negative cash flows, and current plans, additional funding will likely be required to support future operations.
For the quarter ended September 30, 2024, Tharimmune reported negative operating cash flow (OCF) of $2,863,860 and negative free cash flow (FCF) of $2,863,863. These figures reflect the company’s continued investment in research and development activities and the absence of revenue-generating products.
To support its future operations, Tharimmune may seek to raise additional funding through the sale of additional equity or debt securities, enter into strategic partnerships, or pursue other arrangements. The company’s ability to achieve its business objectives and product development timelines may be adversely affected if it is unable to obtain sufficient additional funding.
Recent Developments and Milestones
In July 2023, Tharimmune entered into a Research and Development Collaboration and License Agreement with Applied Biomedical Science Institute (ABSI), granting the company an exclusive, royalty-bearing, sublicensable license to develop and commercialize ABSI products targeting the ErB2 (HER2) and ErbB3 (HER3) receptors.
The company also made significant progress with its lead candidate, TH104, for the treatment of moderate-to-severe chronic pruritus in PBC patients. In October 2024, Tharimmune presented positive Phase 1 data at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting, demonstrating that TH104 was well-tolerated with no unexpected treatment-emergent adverse events. The company expects to initiate a Phase 2 trial for TH104 in PBC patients in 2025 and anticipates obtaining topline data from this trial in Q4 2025.
Additionally, in September 2024, Tharimmune entered into a Patent License Agreement with Intract Pharma, exclusively licensing the global development and commercialization rights (outside of South Korea) for INT-023/TH023, an oral anti-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 is also advancing its early-stage immuno-oncology pipeline. The company plans to advance TH3215, a bispecific antibody targeting HER2 and HER3, into IND-enabling studies in 2025. Additionally, Tharimmune anticipates that TH0059, a HER2-HER3 bispecific ADC, and TH1940, a PD-1 Picobody, will progress to enter IND-enabling studies in 2025.
With respect to TH103, Tharimmune intends to develop the product candidate and potentially file an investigational new drug (IND) application, further expanding its pipeline of potential therapeutic options.
Risks and Challenges
As a clinical-stage biotechnology company, Tharimmune faces several risks and challenges that investors should consider:
Clinical Trial Risks: The company’s clinical trials may not demonstrate the safety and efficacy of its product candidates, which could delay or prevent regulatory approval and commercialization.
Funding and Liquidity Risks: Tharimmune’s ability to continue as a going concern is dependent on its ability to raise additional capital, which may not be available on favorable terms or at all.
Competition Risks: The company operates in a highly competitive industry, and its product candidates may face competition from other therapies, which could impact their commercial potential.
Intellectual Property Risks: Tharimmune’s ability to protect its intellectual property rights is crucial to its success, and any challenges to these rights could adversely affect the company.
Conclusion
Tharimmune is a clinical-stage biotechnology company pioneering innovative solutions in the fields of immunology and inflammation. With a diverse pipeline of therapeutic candidates, including its lead asset TH104 for the treatment of chronic pruritus in PBC patients, Tharimmune is well-positioned to address significant unmet medical needs.
The company’s strategic partnerships, such as the collaboration with ABSI and the licensing agreement with Intract Pharma, further strengthen its capabilities and expand its therapeutic reach. However, as a clinical-stage biotech, Tharimmune faces a range of risks and challenges that investors should carefully consider.
As the company continues to advance its pipeline and navigate the regulatory landscape, its ability to secure additional funding and successfully bring its product candidates to market will be crucial to its long-term success. Investors should closely monitor Tharimmune’s progress and developments to assess the company’s potential to deliver transformative therapies to patients in need.
Disclaimer: This article is for informational purposes only. It does not constitute financial, legal, or other types of advice. While every effort has been made to ensure the accuracy of the information presented here, the author and the publisher do not make any guarantees about the completeness, reliability, and accuracy of this information.