Traws Pharma, Inc.(TRAW) - 2023 Q3 - Quarterly Report

Financial Performance - For the nine months ended September 30, 2023, the company reported net losses of $14.8 million compared to $13.5 million for the same period in 2022, with an accumulated deficit of $478.4 million as of September 30, 2023[63]. - Revenue for the three months ended September 30, 2023, was $57,000, consistent with the same period in 2022[112]. - Net loss for the three months ended September 30, 2023, was $(4,739,000), a decrease of $659,000 compared to $(5,398,000) in 2022[112]. - Other income for the three months ended September 30, 2023, was $350,000, an increase of $107,000 from $243,000 in 2022[112]. - For the nine months ended September 30, 2023, total operating expenses were $16,006,000, an increase of $1,943,000 compared to $14,063,000 in 2022[117]. - General and administrative expenses increased by $0.6 million, or 28%, to $2.7 million for the three months ended September 30, 2023, compared to $2.1 million in 2022[113]. - Research and development expenses decreased by $1.1 million, or 31%, to $2.5 million for the three months ended September 30, 2023, from $3.6 million in 2022[115]. - General and administrative expenses for the nine months ended September 30, 2023, were $7.0 million, up from $6.4 million in 2022[118]. - Research and development expenses for the nine months ended September 30, 2023, were $8.996 million, an increase of $1.363 million from $7.633 million in 2022[117]. - Research and development expenses increased by $1.4 million, or 18%, to $9.0 million for the nine months ended September 30, 2023, compared to $7.6 million for the same period in 2022[26]. - The increase in R&D expenses was primarily due to a $2.6 million rise in clinical and preclinical development costs related to the Phase 1 trials of narazaciclib[26]. - Net cash used in operating activities was $13.5 million for the nine months ended September 30, 2023, compared to $12.4 million for the same period in 2022[127]. - The company expects net cash expenditures in 2023 to be higher than in 2022 due to ongoing clinical trials and increased headcount[129]. Cash Position - As of September 30, 2023, the company had $25.2 million in cash and cash equivalents, which is expected to fund ongoing trials and operations into the third quarter of 2024[64]. - The company plans to explore various funding sources, including equity financings and strategic alliances, to alleviate concerns about its ability to continue as a going concern[124]. Product Development - The product candidate narazaciclib (ON 123300) is a multi-targeted kinase inhibitor with potential efficacy in various cancers, showing a half-maximal inhibitory concentration (IC50) of 2 nM for CDK4 and 0.6 nM for CDK6[68]. - Narazaciclib also demonstrates potent inhibition of ARK5 with an IC50 of 4.95 nM, which is significantly lower than other known inhibitors[70]. - Preclinical studies indicate that narazaciclib exhibits superior antitumor activity against mantle cell lymphoma (MCL) cell lines compared to FDA-approved CDK 4/6 inhibitors, with synergistic effects when combined with ibrutinib[73]. - The company is focused on developing novel products for cancer treatment, with proprietary agents designed to disrupt specific cellular pathways critical for cancer cell proliferation[62]. - The company believes narazaciclib has a favorable kinase inhibitory profile compared to approved CDK4/6 inhibitors, potentially leading to both tumorigenic and safety benefits[93]. - The safety profile of narazaciclib is anticipated to be better than that of approved CDK4/6 inhibitors, with no significant myelosuppression or gastrointestinal toxicity reported in ongoing trials[94]. - The company plans to advance clinical testing of narazaciclib for various advanced malignancies based on promising preclinical data[95]. - A multi-center Phase 1/2a trial evaluating narazaciclib in combination with letrozole for recurrent metastatic low-grade endometrial carcinoma was initiated in Q1 2023, with the first patient dosed in May 2023[101]. - The ongoing Phase 1 study in the US has completed enrollment in the sixth dose cohort (240 mg daily), with one dose limiting toxicity observed, and the seventh cohort (280 mg daily) is currently ongoing[79]. - Narazaciclib has shown similar activity to palbociclib in preclinical models, with potential advantages in reducing neutropenia[81][82]. Collaborations and Regulatory Approvals - The company emphasizes the importance of obtaining regulatory approvals and maintaining collaboration agreements to support its clinical-stage programs[58]. - The company has entered into a collaboration agreement with HanX Biopharmaceuticals for the development and commercialization of narazaciclib in China, receiving an upfront payment and potential future milestone payments and royalties[77]. - The IND for narazaciclib was approved by the Chinese FDA on January 6, 2020, and a Phase 1 study in cancer patients was initiated in September 2020[77][78]. - The US FDA issued a "Study May Proceed" letter for narazaciclib in December 2020, with enrollment in a complementary Phase 1 study starting in May 2021[79]. - The company does not currently have a commercial infrastructure for sales and marketing of pharmaceutical products and may rely on licensing agreements for commercialization[132]. - The company anticipates incurring significant NDA preparation and commercialization expenses if regulatory approval is obtained for its product candidates[131]. Going Concern - The company cautions that substantial doubt exists regarding its ability to continue as a going concern within one year after the issuance of its financial statements[64].