CNTN

Business Context and Reporting Period

Company: Tharimmune, Inc. (formerly Hillstream BioPharma, Inc.)
Filing Type: Form 10-K (Annual Report)
Period Ended: December 31, 2024
Business Overview: Tharimmune is a clinical-stage biotechnology company developing therapeutic candidates for inflammatory, immunologic, and oncologic conditions. The company has no products approved for commercial sale and has not generated any revenue since inception. Its primary focus is on TH104, a transmucosal buccal film for chronic pruritus in Primary Biliary Cholangitis (PBC), and an early-stage pipeline of immuno-oncology candidates (HS1940, HS3215, HS0059).

Key Financial Metrics

Material Changes vs. Prior Period

• Increased Net Loss: Net loss increased by approximately $2.88 million (31%) year-over-year, driven primarily by higher R&D expenses.
• R&D Expense Growth: R&D expenses rose by $2.83 million (80%) due to the completion of the Phase 1 clinical trial for TH104, start-up costs for the Phase 2 trial, and increased license fees ($1.8 million increase).
• Cash Position Decline: Cash balances decreased by approximately $7.38 million, reflecting a net cash burn of $10.9 million from operations, partially offset by $3.5 million in financing proceeds.
• Financing Activity: The company raised approximately $3.6 million in net proceeds from two private placement offerings (June and December 2024) and an at-the-market offering, compared to $12.2 million in public offering proceeds in 2023.

Guidance, Outlook, Risks, and Unusual Items

Outlook and Guidance

• TH104 Development: The company plans to initiate a hepatic impairment study in 2025 prior to launching the Phase 2 trial for TH104 in PBC patients. Topline data from the Phase 2 trial is expected in Q4 2025.
• Pipeline Progress: The company intends to submit INDs for early-stage candidates HS3215 and HS1940 in 2025.
• Capital Needs: Management states the company will require substantial additional funding to support future operations and clinical trials.

Risks and Contingencies

• Going Concern: Management and the independent auditors have expressed 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 due to recurring losses and negative cash flows.
• Liquidity Risk: Failure to secure additional capital could force the company to curtail, delay, or discontinue development programs.
• Termination of Merger: On November 30, 2024, the company terminated a non-binding letter of intent to merge with Intract Pharma Limited, having previously paid $0.3 million in fees related to the transaction.
• Regulatory Risk: Success depends on FDA approval of clinical trial protocols and eventual marketing approval, which is uncertain.

Investor Verification Checklist

• Cash Runway: Verify the current cash balance against the projected burn rate to assess the immediate timeline for required capital raises.
• License Obligations: Review the terms of the Avior, Intract, and Enkefalos license agreements for upcoming milestone payments and royalty obligations that may impact cash flow.
• Phase 2 Trial Status: Confirm the initiation date of the hepatic impairment study and the Phase 2 trial for TH104, as delays could significantly impact the business model.
• Dilution Risk: Monitor future equity offerings, as the company relies heavily on private placements and at-the-market offerings to fund operations, which may dilute existing shareholders.
• Going Concern Status: Assess the company's specific plans to raise capital and the likelihood of success given current market conditions for clinical-stage biotechs.