Business Context and Reporting Period
Company: Tharimmune, Inc. (formerly Hillstream BioPharma, Inc.)
Filing Type: Form 10-Q (Quarterly Report)
Period Ended: March 31, 2025
Business Overview: Tharimmune is a clinical-stage biotechnology company developing therapeutic candidates for rare, inflammatory, and oncologic conditions. The company's lead program, TH104, is a transmucosal buccal film for the treatment of chronic pruritus and the prophylaxis of opioid-induced respiratory depression (PrHPO). The company also holds licenses for oral infliximab (TH023) and is developing an immuno-oncology pipeline targeting HER2, HER3, and PD-1.
Key Financial Metrics
| Metric | Q1 2025 | Q1 2024 |
|---|---|---|
| Revenue | $0 | $0 |
| Net Loss | $(2,541,704) | $(2,256,109) |
| Net Loss Per Share (Basic & Diluted) | $(0.99) | $(2.55) |
| Operating Expenses | $2,546,669 | $2,347,303 |
| Research & Development (R&D) | $594,070 | $1,025,258 |
| General & Administrative (G&A) | $1,952,599 | $1,322,045 |
| Cash and Cash Equivalents (End of Period) | $1,075,928 | $8,427,290 |
| Net Cash Used in Operating Activities | $(2,689,001) | $(2,825,181) |
| Total Current Liabilities | $2,475,965 | $2,413,982 |
| Stockholders' Equity (Deficit) | $(814,671) | $1,307,642 |
Material Changes vs. Prior Period
- Net Loss Increase: Net loss increased by approximately $286,000 (13%) compared to Q1 2024, driven primarily by higher G&A expenses.
- R&D Expenses: Decreased by $431,000 (42%) due to the completion of the Phase 1 clinical trial for TH104 and reduced preclinical vendor costs.
- G&A Expenses: Increased by $631,000 (48%) primarily due to higher investor relations costs ($300,000), corporate taxes ($100,000), and intellectual property expenses ($200,000).
- Liquidity Position: Cash balances declined significantly from $3.56 million at year-end 2024 to $1.08 million at March 31, 2025, reflecting a net cash burn of approximately $2.7 million for the quarter.
- Equity Status: The company moved from positive stockholders' equity ($1.31 million) in December 2024 to a deficit of $(0.81 million) by March 31, 2025.
Outlook, Risks, and Management Commentary
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. The company requires substantial additional funding to support future operations.
Strategic Developments
- TH104 Regulatory Pathway: Received positive FDA feedback in March 2025 regarding a 505(b)(2) New Drug Application (NDA) pathway for the PrHPO indication (opioid prophylaxis). The FDA confirmed no additional clinical trials are required for this indication, designating it as the company's lead program.
- Capital Raising: The company has an active At-The-Market (ATM) agreement. Subsequent to the quarter end (April 2025), the company sold 160,817 shares for net proceeds of approximately $0.25 million.
- License Agreements: The company incurred significant license fees in Q1 2025, including $0.6 million to Intract Pharma and $0.2 million each to Avior and Enkefalos Biosciences.
Risks and Contingencies
- Capital Requirements: Failure to obtain sufficient additional funding could result in delaying or terminating clinical trials.
- Regulatory Uncertainty: While the PrHPO pathway is promising, the company must still complete nonclinical studies and CMC plans.
- Debt Obligations: The company has a note payable of $271,454 (settling legal fees) and an insurance premium financing liability of $248,599.
Investor Verification Checklist
- Cash Runway: Verify the current cash balance and burn rate to assess the immediate timeline for required capital raises.
- ATM Utilization: Monitor the remaining capacity under the $1.65 million ATM agreement and recent share sales.
- License Milestones: Review the payment schedules for Avior, Intract, and Enkefalos agreements to understand future cash outflows.
- FDA Interactions: Confirm the status of the 505(b)(2) NDA submission for TH104 (PrHPO) and the timeline for required nonclinical studies.
- Debt Covenants: Review terms of the note payable and insurance financing to ensure no default risks exist given the current liquidity position.