Business Context and Reporting Period
Company: Tharimmune, Inc. (formerly Hillstream BioPharma, Inc.)
Filing Type: Form 10-Q (Quarterly Report)
Period Ended: September 30, 2024
Business Overview: Tharimmune is a clinical-stage biotechnology company developing therapeutic candidates for rare, inflammatory, and oncologic conditions. Key assets include TH104 (for chronic pruritis in primary biliary cholangitis), TH023 (oral anti-TNF-α), and an early-stage immuno-oncology pipeline targeting HER2, HER3, and PD-1.
Corporate Actions: The company effectuated a 1-for-15 reverse stock split on May 24, 2024. On September 30, 2024, it entered a non-binding Letter of Intent (LOI) to acquire Intract Pharma Limited, a developer of oral biologics delivery platforms.
Key Financial Metrics
| Metric | Three Months Ended Sept 30, 2024 | Nine Months Ended Sept 30, 2024 | As of Sept 30, 2024 |
|---|---|---|---|
| Revenue | $0 | $0 | N/A |
| Net Loss | $(3,795,852) | $(8,377,018) | N/A |
| Net Loss Per Share (Basic/Diluted) | $(2.45) | $(7.39) | N/A |
| Operating Expenses | $3,865,571 | $8,586,328 | N/A |
| Cash and Cash Equivalents | N/A | N/A | $4,774,237 |
| Total Assets | N/A | N/A | $5,251,246 |
| Total Liabilities | N/A | N/A | $2,233,697 |
| Stockholders' Equity | N/A | N/A | $3,017,549 |
| Accumulated Deficit | N/A | N/A | $(33,080,544) |
Cash Flow (Nine Months Ended Sept 30, 2024):
- Net cash used in operating activities: $(7,868,344)
- Net cash provided by financing activities: $1,707,229 (primarily from a PIPE offering)
- Net decrease in cash: $(6,161,115)
Material Changes vs. Prior Period
- Operating Expenses: Total operating expenses increased by $2.0 million (109%) for the three months ended September 30, 2024, compared to the same period in 2023. This was driven by a $1.8 million increase in Research and Development (R&D) expenses and a $0.2 million increase in General and Administrative (G&A) expenses.
- R&D Expenses: The increase in R&D was primarily due to $0.5 million in clinical trial expenses (completion of Phase 1 for TH104), $1.1 million in license fees, and $0.2 million in pre-clinical expenses.
- Net Loss: Net loss widened to $3.8 million for the quarter (from $1.8 million in Q3 2023) and $8.4 million for the nine-month period (from $6.8 million in the prior year).
- Interest Income: Interest income increased significantly to $72,728 for the quarter (from $28,451) due to higher cash balances from recent capital raises.
- Liquidity: Cash and cash equivalents decreased from $10.9 million at year-end 2023 to $4.8 million at September 30, 2024.
Guidance, Outlook, Risks, and Unusual Items
- Going Concern: Management has concluded that prevailing conditions raise substantial doubt about the Company's ability to continue as a going concern for at least one year following the issuance date. The Company requires substantial additional funding to support operations.
- Capital Raises: In June 2024, the Company closed a PIPE offering raising approximately $1.8 million in net proceeds. An At-the-Market (ATM) facility for up to $1.65 million was also established.
- Strategic Transactions:
- Intract Acquisition: Entered an LOI to acquire Intract Pharma Limited. Upon closing, Intract shareholders would own 49% of the combined entity.
- Licensing: Signed agreements with Avior (TH104/TH103), Intract (oral infliximab), Enkefalos (cyclotides), and ABSI (HER2/HER3 targets). Significant milestone payments and royalties are contingent on future development and sales.
- Outlook: The Company expects to obtain topline data for the TH104 Phase 2 trial in Q4 2025. IND-enabling studies for TH3215, TH0059, and TH1940 are anticipated in 2025.
- Risks: Key risks include the need for additional capital, failure of clinical trials, regulatory approval uncertainties, and dependence on third-party suppliers and licensors.
Investor Verification Checklist
- Cash Runway: Verify the current cash burn rate against the $4.8 million cash balance to assess the immediate need for further capital raises.
- Intract Merger Terms: Monitor the progress of the definitive agreement for the Intract acquisition and the final dilution impact on existing shareholders (projected 49% ownership for Intract).
- Licensing Obligations: Review the specific milestone payment triggers and royalty rates in the Avior, Intract, Enkefalos, and ABSI agreements, as these represent significant future cash outflows.
- Reverse Stock Split Impact: Confirm the trading volume and liquidity of the stock following the 1-for-15 reverse split effectuated in May 2024.
- Going Concern Status: Evaluate the Company's ability to secure funding before the next reporting period to avoid potential delisting or operational delays.