Pieris Pharmaceuticals (PIRS) Q2 2024 earnings summary

Executive summary

• Entered into a definitive merger agreement with Palvella Therapeutics, expected to close in Q4 2024, with Pieris shareholders to own ~18% and Palvella shareholders ~82% of the combined company, subject to adjustments and approvals.

• Discontinued all proprietary R&D activities and implemented significant cost-saving measures, including workforce reductions and asset sales, to extend cash runway into at least 2027.

• Completed enrollment in Phase 3 SELVA trial for QTORIN rapamycin in microcystic lymphatic malformations, exceeding target by over 25%.

• Top-line results for SELVA expected Q1 2026; Phase 2 TOIVA trial for cutaneous venous malformations on track for Q4 2025 results.

• Focused on maximizing milestone and royalty potential from partnered immuno-oncology programs with Pfizer and Boston Pharmaceuticals.

Financial highlights

• Reported net loss of $3.6 million for Q2 2024, compared to net income of $4.0 million in Q2 2023; net loss of $8.5 million for the six months ended June 30, 2024, versus $9.2 million loss in the prior year period.

• Revenue for Q2 2024 was $20,000, down from $20.1 million in Q2 2023, reflecting the completion of performance obligations under prior collaborations.

• Cash and cash equivalents totaled $19.7 million as of June 30, 2024.

• Cash and cash equivalents of $70.4 million as of June 30, 2025, expected to fund operations into H2 2027.

• Net loss attributable to common stockholders was $9.5 million ($0.86 per share) for Q2 2025, compared to $4.4 million ($2.47 per share) in Q2 2024.

Outlook and guidance

• Current cash position expected to fund limited operations for at least the next 12 months.

• Cash runway expected to fund operations into the second half of 2027, supporting current strategic agenda.

• If the merger is not completed, alternatives include pursuing another strategic transaction, continuing to operate as a milestone/royalty entity, or dissolving and liquidating assets.

• Top-line data from SELVA and TOIVA trials anticipated in Q1 2026 and Q4 2025, respectively.

• Announcements of new clinical programs and platform candidates planned for H2 2025.