Business Context and Reporting Period
Company: Tharimmune, Inc. (formerly Hillstream BioPharma, Inc.)
Filing Type: Form 10-Q (Quarterly Report)
Period Ended: June 30, 2025
Business Overview: Tharimmune is a clinical-stage biotechnology company developing therapeutic candidates in immunology and inflammation. Key programs include TH104 (for opioid overdose prophylaxis and chronic pruritus), TH023 (oral infliximab), and early-stage immuno-oncology candidates (HS1940, HS3215). The company is classified as a smaller reporting company and an emerging growth company.
Key Financial Metrics
| Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 |
|---|---|---|
| Revenue | $0 | $0 |
| Net Loss | $(4,396,857) | $(4,581,166) |
| Net Loss Per Share (Basic & Diluted) | $(1.61) | $(4.96) |
| Operating Expenses | $4,397,829 | $4,720,757 |
| Research & Development (R&D) | $1,140,274 | $2,024,811 |
| General & Administrative (G&A) | $3,257,555 | $2,695,946 |
| Cash and Cash Equivalents (End of Period) | $2,241,980 | $7,895,827 |
| Net Cash Used in Operating Activities | $(3,831,531) | $(5,004,484) |
| Net Cash Provided by Financing Activities | $2,514,150 | $1,964,959 |
| Total Liabilities | $2,162,807 | $2,413,982 |
| Stockholders' Equity | $367,359 | $1,307,642 |
Material Changes vs. Prior Period
- Net Loss Reduction: Net loss decreased by approximately $184,000 (4%) compared to the prior six-month period, primarily driven by a $884,000 reduction in R&D expenses.
- R&D Expenses: Decreased by 44% ($884,537) due to lower pre-clinical vendor expenses, reduced license fees, and decreased clinical trial costs. This was partially offset by a $200,000 increase in stock-based compensation.
- G&A Expenses: Increased by 21% ($561,609) due to higher stock-based compensation ($300,000 increase), increased investor relations fees ($500,000 increase), and director remuneration, partially offset by lower personnel expenses.
- Liquidity: Cash and cash equivalents declined by approximately $1.3 million during the period, reflecting a net cash burn of $3.8 million in operations partially funded by $2.5 million in financing activities.
- Capital Structure: The company completed a June 2025 PIPE offering raising approximately $2.3 million net and utilized its At-The-Market (ATM) facility to raise approximately $0.2 million.
Guidance, Outlook, Risks, and Unusual Items
- Going Concern Warning: Management has concluded that prevailing conditions and ongoing liquidity risks raise substantial doubt about the company's ability to continue as a going concern for at least one year following the issuance of the financial statements. Substantial additional funding is required.
- Strategic Focus: The company is prioritizing a capital-efficient strategy to file a 505(b)(2) New Drug Application (NDA) for TH104 for the prophylaxis of opioid overdose (PrHPO). The FDA confirmed that no additional clinical trials are required for this indication, only nonclinical toxicology studies.
- Recent Financing: In July 2025 (subsequent to the period end), the company closed two additional offerings raising approximately $2.8 million combined ($1.74 million registered direct and $1.1 million private placement).
- Executive Changes: The former CEO resigned in June 2025 and entered a settlement agreement. The former COO was appointed CEO, and a new Executive Chairman was appointed.
- Risks: Key risks include the need for additional capital, dependence on third-party suppliers, regulatory approval uncertainties, and the potential for clinical trial failures.
Investor Verification Checklist
- Cash Runway: Verify the current cash balance against the stated monthly burn rate to assess the immediate need for further capital raises.
- Financing Terms: Review the terms of the June 2025 and July 2025 PIPE offerings, specifically the exercise prices of warrants and potential dilution to existing shareholders.
- License Obligations: Confirm upcoming milestone payments and royalty obligations under the Avior, Intract, and ABSI license agreements.
- Regulatory Pathway: Monitor the status of the Pre-Investigational New Drug Application (PIND) and subsequent NDA submission for TH104 (PrHPO indication).
- Stock-Based Compensation: Analyze the impact of recent equity grants and the "evergreen" provision in the 2023 Stock Incentive Plan on future dilution.