Traws Pharma, Inc. Q1 FY2023 earnings call

• Progress of Phase I/IIa trial of narazaciclib combined with letrozole in low-grade endometrioid endometrial cancer, with first patient dosed this week.
• Planned regulatory interactions around rigosertib's Phase II program in RDEB-associated squamous cell carcinoma, including a FDA Type B meeting request.
• Narazaciclib showed acceptable safety profile in Phase I monotherapy trial, with engagement of targets and starting to see effects on bone marrow function.
• Rigosertib's Phase II program in RDEB-associated SCC had patients achieving complete clinical responses, well-tolerated, and request for Type B Meeting with FDA.
• Collaborated with Pangea Biomed to use their platform to identify biomarkers for rigosertib.
• Updates on rigosertib combination trials: Phase II trial with KEYTRUDA in metastatic melanoma (enrollment opened) and Phase I/IIa trial with OPDIVO in KRAS-mutated non-small cell lung cancer (recruiting patients).

No detailed breakdown of financial performance by product segments as the transcript does not present revenue contributions from distinct product segments.

• Expect first readout to establish combination dose from Phase I/IIa trial of narazaciclib combined with letrozole in endometrial cancer.
• Important regulatory update on rigosertib's RDEB-associated squamous cell carcinoma program in the third quarter after Type B Meeting.
• Updated efficacy and safety data from Phase I/IIa trial of rigosertib plus OPDIVO in non-small cell lung KRAS-mutated cancer to include additional patients.

• Forward-looking statements involve risks and uncertainties that can cause actual results to differ materially. Risks related to clinical trial outcomes, regulatory interactions, and safety profiles of drugs as highlighted in SEC filings.

Q: About narazaciclib's profile, when will hematologic adverse events be seen and if there will be lessened impacts due to drug's kinome tree.

A: You don't know until dose escalates; already seeing minor decreases in total white counts. Translating monotherapy trial, opened doublet trial early.

Q: About rigosertib's commercialization and patient identification for RDEB-associated SCC.

A: Goal is to get rigosertib approved in ultra-rare disease, and rigosertib's PLK1 inhibition may apply to more common squamous cell carcinomas; working on identifying percentage of PLK-driven squamous cells.

Q: About narazaciclib's CDK 4/6 activity in endometrial cancer and patient exclusion if they had CDK 4/6 treatment previously.

A: Don't know exact number of patients treated off-label with FDA-approved CDK 4/6 inhibitors; patients who failed FDA-approved CDK 4/6 inhibitors may be permitted on trial as it's about getting optimal dose of combination.

Q: About timelines for solid tumor trials (narazaciclib and rigosertib).

A: Anticipate recommended Phase II dose in endometrial cancer by end of year, then initiate pivotal Phase III trial in early 2024; rigosertib in non-small cell lung cancer trial expected to complete by end of 2023, may dose escalate rigosertib if safety permits.