TRexBio — Third Quarter 2026 Earnings Summary

Financial Performance:

• Net loss was $13.2 million for the third quarter ended September 30, 2026, compared to $7.9 million in the same period of 2025.
• Research and development (R&D) expenses were $11.4 million for the third quarter of 2026, an increase from $7.0 million in the third quarter of 2025.
• General and administrative (G&A) expenses were $2.5 million for the third quarter of 2026, compared to $1.7 million in the third quarter of 2025.
• Cash, cash equivalents, and marketable securities totaled $78.2 million as of September 30, 2026, excluding the $119.0 million in net proceeds from the October 2026 IPO.
• Total operating expenses for the nine months ended September 30, 2026, were $44.9 million, compared to $27.9 million for the same period in 2025.
• Net loss for the nine months ended September 30, 2026, was $42.5 million, compared to $25.6 million in the prior year period.
• Interest income was $768,000 for the three months ended September 30, 2026, compared to $853,000 in the same period of 2025.

Guidance and Future Outlook:

• Topline Phase 1b data for TRB-061 in atopic dermatitis is expected in mid-2027.
• Initiation of a Phase 1 clinical trial for TRB-071 is expected in the first half of 2027, subject to regulatory allowance.
• Based on current operating plans and including IPO net proceeds, the company expects to fund operations and capital expenditure requirements into the second half of 2029.
• Eli Lilly intends to advance the partnered program TRB-051 into a Phase 2a clinical trial in lupus with cutaneous involvement.

Business Segments and Product Lines:

• TRB-061 (TNFR2 agonist) reported positive Phase 1a topline results in August 2026, demonstrating proof of mechanism with consistent pharmacokinetics and reproducible activation/expansion of immunoregulatory Tregs in healthy volunteers.
• TRB-061 was generally well tolerated across all dose levels in Phase 1a, with no treatment-related serious adverse events or dose-limiting toxicities observed.
• The Phase 1b trial for TRB-061 is currently evaluating safety, pharmacokinetics, pharmacodynamic biomarkers, and exploratory measures of clinical activity in patients with moderate-to-severe atopic dermatitis.
• TRB-071 (CD30 agonist) is advancing through IND-enabling studies to augment tissue Tregs and block inflammatory signaling pathways.
• TRB-051 is in clinical development through a collaboration with Eli Lilly.

Market and Competitive Landscape:

• The company faces potential competition from large and specialty pharmaceutical and biotechnology companies that already have approved therapies in its current indications.
• TRexBio's strategy focuses on addressing unmet needs in autoimmune and inflammatory diseases by restoring immune balance and promoting tissue repair.

Risks and Challenges:

• The company has a limited operating history, lacks products approved for commercial sale, and anticipates incurring substantial and increasing losses for the foreseeable future.
• There is a need for substantial additional financing to achieve goals, and clinical development is lengthy, expensive, and uncertain.
• Risks include the possibility that earlier study results may not predict future trial results, delays in patient enrollment, and potential adverse events or side effects.
• A material weakness was identified in the company's internal control over financial reporting.
• The company relies on third parties for preclinical and clinical studies and on suppliers located outside the United States.

Management Commentary and Tone:

• CEO Johnston Erwin stated that positive Phase 1a results provided clinical evidence supporting the company's approach of selectively activating and expanding immunoregulatory Tregs in humans.
• Management expressed focus on determining if observed effects translate into meaningful and durable disease control for patients.
• The completion of the IPO is viewed as providing the necessary resources to advance TRB-061 toward the mid-2027 readout and bring TRB-071 into the clinic.

Other Key Points:

• TRexBio completed an initial public offering in October 2026, selling 9,539,237 shares at $14.00 per share.
• Gross proceeds from the IPO were approximately $133.5 million, with net proceeds of approximately $119.0 million after deducting underwriting discounts, commissions, and offering expenses.
• The company's common stock trades on the Nasdaq Global Select Market under the ticker symbol "TRXB."
• The IPO resulted in the automatic conversion of all outstanding redeemable convertible preferred stock into 17,742,217 shares of common stock.
• R&D expense increases were driven by higher clinical trial costs for TRB-061, increased preclinical development and manufacturing for TRB-071, and higher personnel and facility costs.
• G&A expense increases were primarily attributable to higher personnel-related expenses and professional fees, including accounting and audit costs associated with operating as a public company.