Traws Pharma, Inc. Q2 FY2023 earnings call

• Dr. Steve Fruchtman introduced the company's focus on developing novel cancer therapies, highlighting narazaciclib (CDK4/6 inhibitor) and rigosertib (cell-signaling inhibitor). • Progress on narazaciclib: Completing Phase I program to define recommended Phase II dose (RP2D), with plans to initiate randomized trial in low-grade endometrioid endometrial cancer (LGEEC) in H1 2024. • Progress on rigosertib: Constructive Type B meeting with FDA regarding RDEB-associated squamous cell carcinoma, planning registrational trial, and ongoing investigator-sponsored trials (IST) with checkpoint inhibitors in melanoma and KRAS-mutated non-small cell lung cancer (NSCLC). • Introduction of Dr. Victor Moyo as Consulting Chief Medical Officer, who provided updates on narazaciclib's unique attributes (differentiated safety profile, once-daily dosing, targeting resistant pathways) and rigosertib's potential in RDEB. • Financial overview by Mark Guerin: Cash and cash equivalents at $29.7M as of Q2 2023, R&D expenses $2.5M, G&A expenses $2.2M, net loss $4.3M.

No specific segment performance data on absolute revenue and contribution % provided in the transcript.

• For narazaciclib: Anticipate topline results from Phase I monotherapy and Phase I/II combination studies with letrozole in Q4 2023; plan to advance the narazaciclib-letrozole combination into a randomized trial in LGEEC in H1 2024. • For rigosertib: Design registrational trial for RDEB-associated squamous cell carcinoma, provide update on next steps in H1 2024; continue IST studies with checkpoint inhibitors in melanoma and KRAS-mutated NSCLC.

• Forward-looking statements involve risks and uncertainties that can cause actual results to differ materially. • Uncertainties related to clinical trial outcomes, regulatory approvals, and market acceptance of the products.

Q: Edouard Mullarky asked about narazaciclib monotherapy dose escalation and letrozole combo trial progress.

A: Dr. Steve Fruchtman discussed ongoing dose escalation, expanding cohorts, and letrozole combo trial accrual, noting they're in the middle of expanding the 240 mg daily cohort and expect to know recommended Phase II dose by end of 2023.

Q: Ahu Demir asked about narazaciclib safety signals and solid tumor trial enrollment.

A: Dr. Steve Fruchtman mentioned no overlapping toxicity between narazaciclib and antiestrogens, and solid tumor trial enrollment is diverse across various cancer types with no single indication dominating.

Q: Surendar asked about narazaciclib initial efficacy data and rigosertib RDEB trial enrollment.

A: Dr. Steve Fruchtman explained CDK4/6 inhibitors don't show early efficacy, and rigosertib trial has patients on compassionate use, with plans to transition to an Onconova-sponsored trial and work with FDA for registrational path.

Q: Robert LeBoyer asked about melanoma trial progress.

A: Dr. Steve Fruchtman stated the melanoma trial is early stage, first cohort nearly complete, with no safety concerns, and next cohort up to three patients.