Traws Pharma, Inc. Q3 FY2023 earnings call

• Lead program narazaciclib: Internal efforts on basic preparations, designed as next-gen CDK4/6 inhibitor with potential for improved tolerability and efficacy. Preclinical studies show impact on vital targets. Selected low-grade endometrial cancer as lead registration indication. Phase 1/2 program ongoing with dose escalation, extending into Q1 2024. • Rigosertib: Focus on ultra-rare indication of RDEB-associated squamous cell carcinoma. Planned to provide update on orphan drug designation and registration program in H1 2024. • Financials: Cash and cash equivalents at $25.2M as of Q3 2023, research and development expenses $2.5M, general and administrative expenses $2.7M, net loss $4.7M. • Milestones: Continue narazaciclib dose escalation, provide safety and pharmacology readout in H1 2024, update on registration trial readiness; for rigosertib, update on orphan drug designation and registration program in H1 2024.

Onconova does not have distinct product segments with revenue contributions as discussed. The focus is on two main programs: narazaciclib, a proprietary protein kinase inhibitor of CDK4/6 and other kinases, and rigosertib, exploring clinical utility through investigator-sponsored trials.

• Continue dose escalation segment of narazaciclib Phase 1/2 program into Q1 2024. • Provide readout on narazaciclib safety and pharmacology in first half of 2024. • Update on narazaciclib registration trial readiness, including recommended Phase 2 dose, FDA engagement, and work with external experts in H2 2024. • Provide update on rigosertib orphan drug designation and registration program in first half of 2024.

• Clinical trial delays due to dose escalation and need for wider therapeutic index evaluation. • Regulatory hurdles in obtaining orphan designation and approval for rigosertib in RDEB-associated SCC. • Market competition from existing CDK4/6 inhibitors and other oncology drugs.

Q: How is the narazaciclib plus letrozole combination trial tracking and when could initial efficacy data be seen?

A: Still in dose escalation due to wider therapeutic index requiring higher doses, extending into 2024. Efficacy data in registration track will focus on PFS and overall survival as CDK4/6 inhibitors are not cytotoxic.

Q: On monotherapy dose escalation for narazaciclib, how much room is there to escalate and how is efficacy considered?

A: Decision on optimal dose for Phase 2 will consider safety, PK characteristics, and pharmacodynamic studies. Focus on PK, tolerability, and pharmacodynamics.

Q: Steps to remove one week off dosing for narazaciclib?

A: Currently dosing continuously, and discussions with agency will be based on continuous dosing safety, with recommended Phase 2 dose including continuous dosing.

Q: Enrollment and patient types in narazaciclib monotherapy trial?

A: Enrolled diverse set of solid tumor patients, no particular pattern standing out.

Q: Steps to get rigosertib orphan designation?

A: Explain to FDA why RDEB-associated SCC is distinct from spontaneous squamous cell, request face-to-face meeting or respond to written briefing book, focusing on disease differences and patient prognosis.