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Traws Pharma, Inc.

Traws Pharma, Inc. Q3 FY2022 earnings call

November 14, 2022 · fiscal period ended 2022-09

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Summary

Generated 2022-11-14

Management highlights

  1. Announced plan to conduct Phase 1/2a clinical trial of narazaciclib combined with letrozole in endometrial cancer. Rationale included unmet medical need in endometrial cancer, high probability of technical/regulatory success, and opportunity to establish narazaciclib as best-in-class. 2. Narazaciclib Phase 1 solid tumor trials in US and China ongoing, safety encouraging, with anticipation of identifying recommended Phase 2 dose in first half of 2023. 3. Rigosertib updates: ESMO presentation of data, plan to initiate Phase 2 trial with pembrolizumab in melanoma, and ongoing trial in squamous cell carcinoma with promising responses. 4. Financials: Q3 2022 research and development expenses $3.6M, general and administrative expenses $2.1M, net loss $5.4M.
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Guidance

  1. Anticipate initiating Phase 1/2a study in endometrial cancer in Q1 2023, with preliminary data in Q4 2023. 2. Expect to identify recommended Phase 2 dose for narazaciclib in first half of 2023. 3. Look for additional data from rigosertib's nivolumab combination study in first half of 2023. 4. Plan to initiate investigator sponsored study in metastatic malignant melanoma with rigosertib and pembrolizumab.
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Risks

  1. Forward-looking statements involve risks and uncertainties that can cause actual results to differ materially. 2. Risks related to clinical trial outcomes, regulatory approval processes, and safety profiles of therapies.
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Q&A highlights

Q: Regarding the narazaciclib combination with letrozole, how should we think about the cadence of dose escalation relative to single agent?

A: Dr. Mark Gelder stated they'll start the Phase 1 dose of narazaciclib at 200 mg/day (where they are in the fifth dosing cohort) combined with 2.5 mg/day letrozole, and dose escalation will proceed in 40 mg increments, looking at PK and safety.

Q: Have you shown any data from endometrial cancers as a single agent activity with narazaciclib?

A: Dr. Mark Gelder responded that there's no data with narazaciclib as a single agent in endometrial cancer, and other CDK 4/6 inhibitors have combined with letrozole in this setting.

Q: Regarding financial guidance, in R&D expense increase, what's the outlook for next several quarters?

A: Mark Guerin said historic quarterly cash burn rate was ~$4M-$4.2M, and with the Phase 1/2a combination study, burn will increase, with cash expected to fund operations into 2024.

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Transcript

November 14, 2022

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