Traws Pharma, Inc. Q4 FY2022 earnings call

• Narazaciclib's Phase I/IIa combination trial with estrogen blockade in endometrial cancer is on track to open for enrollment later this quarter. Phase I trials of single-agent narazaciclib in the U.S. and China have shown a favorable safety profile through fifth dose escalation cohorts, with plans to place patients on once-daily continuous dosing. - Rigosertib's Phase II data in advanced squamous cell carcinoma complicating RDEB was highlighted, with plans to seek FDA guidance on expedited approval. Preclinical data on rigosertib presented at AACR targeting RAS conference. - Appointments of Drs. Peter Atadja and Trafford Clarke to the Board of Directors. - Upcoming posters on narazaciclib at AACR meeting, including data on activity against mantle cell lymphoma and differential cellular targets compared to FDA-approved CDK4/6 inhibitors. - Cash and cash equivalents at $38.8 million as of end-2022, sufficient to fund operations into Q1 2024.

In 2022, research and development expenses were $11.4 million compared to $7.3 million in 2021. General and administrative expenses were $8.4 million in 2022 versus $9.4 million in 2021. The net loss for 2022 was $19 million or $0.91 per share on 20.9 million weighted average shares outstanding, compared to a net loss of $16.2 million or $0.96 per share in 2021. The increase in net loss was primarily due to higher spending in the narazaciclib development program and drug manufacturing in 2022.

• Anticipate preliminary data from narazaciclib and letrozole combo trial in advanced endometrial cancer in Q4 2023. - Continued progress in narazaciclib Phase I trials to select recommended Phase II dose and initiate narazaciclib in additional cancer indications. - Discuss rigosertib's RDEB-associated squamous cell carcinoma data with FDA. - Open rigosertib and pembrolizumab combo trial in melanoma later this quarter. - Expect additional data from rigosertib and nivolumab trial in KRAS-mutated non-small cell lung cancer in Q2.

• Risks associated with clinical trial outcomes, including safety and efficacy of narazaciclib and rigosertib. - Regulatory hurdles in obtaining approvals for narazaciclib and rigosertib. - Uncertainties in advancing clinical programs and potential delays. - Risks related to the competitive landscape and emerging therapies.

Q: On narazaciclib monotherapy dose escalation, can you give more color on dose escalation, potential therapeutically efficacious range, and if monotherapy dose escalation data update could come before 4Q letrozole combo data?

A: Dr. Gelder stated they believe they're close to a recommended Phase II dose, seeing some grade 1/2 neutropenia and low-grade diarrhea, but PD work for 200-milligram cohort is pending. Can't say for certain when monotherapy data might update, but they're getting close.

Q: On similarities/differences between narazaciclib and other CDK4/6 inhibitors in safety profile?

A: Mark Gelder explained narazaciclib differentiates by hitting other kinases at low nanomolar concentration (unlike pure CDK4/6 inhibitors palbo and ribo), with abemaciclib hitting different kinases. Safety profile so far looks good with low-grade neutropenia and diarrhea. More detail at AACR meeting.

Q: On rigosertib's potential in RDEB, any broad strokes on regulatory wish list?

A: Steven Fruchtman mentioned seeking FDA guidance on expedited approval for rigosertib in RDEB-associated squamous cell carcinoma, and discussing potential pediatric voucher for pediatric RDEB patients.

Q: On narazaciclib sixth cohort timeline, can you give timeframes for cohort completion?

A: Mark Gelder said it's impossible to predict exact timelines as it depends on DLTs, screen failures, etc. Typically, cohorts take 2-3 months if no issues, but decision on dose also depends on PD data.