Tharimmune (THAR) investor relations material

Executive summary

• Clinical-stage biotech focused on immunology and inflammation, advancing TH104 for opioid overdose prophylaxis and pruritus in PBC, and developing early-stage immuno-oncology assets including bispecific antibodies and novel delivery platforms.

• Positive FDA feedback received for TH104's new indication, enabling a 505(b)(2) NDA pathway with no additional clinical trials required for the lead program.

• Multiple licensing agreements in place, including with Avior, Intract, and ABSI, supporting pipeline expansion and technology access.

• Strategic focus on capital efficiency, partnerships, and potential M&A to maximize pipeline value.

Financial highlights

• Net loss for Q2 2025 was $1.86 million, compared to $2.33 million in Q2 2024; net loss for the six months ended June 30, 2025 was $4.40 million, down from $4.58 million year-over-year.

• Research and development expenses decreased 45% year-over-year to $0.55 million for Q2 2025, primarily due to lower pre-clinical and license fees, offset by higher stock-based compensation.

• General and administrative expenses decreased 5% to $1.30 million for Q2 2025, with lower personnel costs partially offset by higher investor relations fees.

• Cash and cash equivalents were $2.24 million as of June 30, 2025, down from $3.56 million at year-end 2024.

• Accumulated deficit reached $41.3 million as of June 30, 2025.

Outlook and guidance

• Substantial additional funding is required to support future operations; management has concluded that substantial doubt exists about the ability to continue as a going concern for at least one year.

• Plans to seek additional capital through equity or debt offerings, partnerships, or grants, but no assurance of success or timing.

• Focus remains on advancing TH104 regulatory filings and progressing CMC activities for NDA submission.