Financial Performance - The Company reported net losses of $136.6 million for the nine months ended September 30, 2024, compared to $14.8 million for the same period in 2023, resulting in an accumulated deficit of $619.2 million as of September 30, 2024[97]. - Revenues for the three months ended September 30, 2024 were $57,000, consistent with the same period in 2023[139]. - Total operating expenses for the nine months ended September 30, 2024 were $137.3 million, significantly higher than $16.0 million in the same period of 2023[146]. - The Company incurred transaction costs of approximately $8.7 million related to the planned Merger during the nine months ended September 30, 2024[131]. - Net cash used in operating activities was $25.8 million for the nine months ended September 30, 2024, primarily due to a net loss of $136.6 million and a $7.7 million change in operating assets and liabilities[156]. - Significant non-cash charges of $118.5 million were recorded, mainly from the immediate expensing of in-process research and development related to the acquisition of Trawsfynydd, totaling $117.5 million[156]. - The company has not achieved profitability since inception and expects to continue incurring net losses for the foreseeable future[160]. - Projected net cash expenditures in 2024 are expected to be higher than in 2023 due to advancements in clinical trials and significant transaction-related costs associated with the Merger[160]. Cash Position and Funding - As of September 30, 2024, the Company had $5.4 million in cash and cash equivalents and raised gross proceeds of $14 million through a Securities Purchase Agreement on April 1, 2024[98]. - The company believes its cash and cash equivalents will fund ongoing trials and operations into the first quarter of 2025, but raises substantial doubt about its ability to continue as a going concern beyond that period[160]. - The Company is exploring various sources of funding for development and ongoing operations, with substantial doubt regarding its ability to continue as a going concern[98][99]. - The Company plans to explore various funding sources to alleviate substantial doubt about its ability to continue as a going concern[152]. - Net cash provided by financing activities was $14.0 million for the nine months ended September 30, 2024, from the private placement of Common Stock[159]. Clinical Development - TRX100, a small molecule cap-dependent endonuclease inhibitor, is being developed for the treatment and prophylaxis of seasonal influenza and bird flu[100]. - The Phase 1 clinical study of TRX100 showed good overall tolerability, with a single dose maintaining plasma drug levels above the EC90 for more than 20 days[104]. - TRX01, an inhibitor of the main protease of the SARS-CoV-2 virus, demonstrated inhibition of viral replication in preclinical studies and is planned for further development[105]. - The Phase 1 trial of TRX01 included 40 participants and showed no treatment-related adverse events, with plasma drug levels maintained within the therapeutic window for 12 days[106]. - The Company plans to initiate a Phase 2 study for both TRX100 and TRX01 in the first half of 2025[104][106]. - Narazaciclib is being evaluated in a multi-center Phase 1/2a trial for recurrent metastatic low-grade endometrioid endometrial cancer, with approximately 30 patients expected to enroll in the Phase 2 expansion cohort[107]. - A Phase 1 study of narazaciclib as a monotherapy is ongoing to assess safety and tolerability in patients with relapsed and/or refractory advanced cancer[108]. - The company plans to initiate two investigator-initiated studies in the USA for narazaciclib, targeting patients with refractory breast cancer and multiple myeloma[109]. - Rigosertib is being studied for epidermolysis bullosa-associated squamous cell carcinoma, with the company pursuing orphan drug designation from the FDA[111]. Corporate Actions - On April 1, 2024, the company completed a merger with Trawsfynydd Therapeutics, issuing 141,982 shares of Common Stock and 10,359.0916 shares of Series C[117]. - The merger is intended to qualify as a tax-free reorganization for U.S. federal income tax purposes[116]. - The company raised approximately $14 million through a private placement, issuing 19,879 shares of Common Stock and 1,578.2120 shares of Series C[125]. - The company has filed a registration statement with the SEC for the resale of shares related to the merger, which was declared effective on August 28, 2024[126]. - A reverse stock split of one-for-25 was approved by the Board in September 2024, retroactively adjusting all related share information[113]. - The company regained compliance with Nasdaq's minimum bid price requirement after its common stock closed at least $1.00 per share for ten consecutive business days[114]. - The Company was notified of non-compliance with Nasdaq's minimum stockholders' equity requirement and attended a hearing to present its compliance plan[153]. Operational Challenges - The Company expects to incur significant expenses and operating losses for the foreseeable future as it continues the development of its product candidates[97]. - There is currently no organization for sales, marketing, and distribution of pharmaceutical products, and the company may rely on licensing and co-promotion agreements for commercialization[161]. - Additional costs are expected to be incurred associated with operating as a public company and fulfilling obligations under the Merger Agreement and related agreements[161].

Financial Performance - As of September 30, 2024, Traws Pharma had cash, cash equivalents, and short-term investments of approximately $5.4 million, down from $20.8 million at December 31, 2023[6]. - The net loss for Q3 2024 was $8.5 million, or $8.81 per share, compared to a net loss of $4.7 million, or $5.64 per share, for the same period in 2023[9]. - Traws Pharma's accumulated deficit increased to approximately $619.2 million as of September 30, 2024, compared to $482.6 million at the end of 2023[14]. - The company reported total liabilities of $10.97 million as of September 30, 2024, down from $12.01 million at the end of 2023[14]. Research and Development - Research and development (R&D) expenses for Q3 2024 totaled $5.1 million, compared to $2.5 million for the same period in 2023, reflecting a significant increase due to the initiation of Phase 1 studies[7]. - Traws Pharma is advancing its antiviral programs, with Phase 2 studies for ratutrelvir and tivoxavir marboxil expected to commence in 2025[2]. - Phase 1 data for ratutrelvir indicates it can be dosed without ritonavir, showing no treatment-related adverse events and consistent plasma drug levels[3]. - Phase 1 data for tivoxavir marboxil supports its potential as a single-dose treatment for influenza, maintaining plasma drug levels above the EC90 for over five days[4]. Operating Expenses - General and administrative (G&A) expenses for Q3 2024 were $3.5 million, up from $2.7 million in Q3 2023, primarily due to increased professional and consulting fees[8]. - Traws Pharma's total operating expenses for Q3 2024 were $8.6 million, compared to $5.1 million for the same period in 2023[15].

Core Insights - Traws Pharma is advancing its clinical pipeline with promising Phase 1 data for its antiviral programs targeting COVID-19 and influenza, indicating potential for best-in-class treatments [2][3] Clinical Development - Ratutrelvir shows potential as a once-a-day, single-drug, 10-day treatment for COVID-19 without the need for ritonavir, demonstrating lower likelihood of clinical rebound and good tolerability [1][3] - Tivoxavir marboxil is positioned as a one-time treatment for influenza, including pandemic strains, with favorable pharmacokinetic profiles and tolerability [1][3] Upcoming Milestones - Phase 2 clinical proof of concept studies for both ratutrelvir and tivoxavir marboxil are expected to commence in 2025 [2][3] Financial Performance - As of September 30, 2024, Traws Pharma reported cash and cash equivalents of approximately $5.4 million, a decrease from $20.8 million at December 31, 2023 [5] - Research and development expenses for Q3 2024 totaled $5.1 million, up from $2.5 million in Q3 2023, primarily due to Phase 1 study costs [6] - General and administrative expenses increased to $3.5 million in Q3 2024 from $2.7 million in Q3 2023, driven by higher professional fees [7] - The net loss for Q3 2024 was $8.5 million, compared to a net loss of $4.7 million in the same period of 2023 [8] Company Overview - Traws Pharma is a clinical stage biopharmaceutical company focused on developing oral small molecule therapies for respiratory viral diseases and cancer [9][10]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 (Mark One) FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-36020 Traws Pharma, Inc. (Exact name of registrant as specified in its charter) | --- | --- | |--------------------------------------------------- ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 (Mark One) FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-36020 Traws Pharma, Inc. (Exact name of registrant as specified in its charter) | --- | --- | |-------------------------------------------------- ...

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Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 (Mark One) FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-36020 Onconova Therapeutics, Inc. (Exact name of registrant as specified in its charter) (I.R.S. Employer Identification No.) 18940 Registran ...

[PART I — FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20%E2%80%94%20FINANCIAL%20INFORMATION) [Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents Onconova Therapeutics' unaudited condensed consolidated financial statements for Q2 and H1 2023, detailing financial position, operations, and cash flows [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2023, the balance sheet shows total assets decreased to **$30.5 million** from **$39.4 million**, primarily due to reduced cash, while stockholders' equity significantly declined Condensed Consolidated Balance Sheets (in thousands) | | June 30, 2023 (unaudited) | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $29,729 | $38,757 | | Total current assets | $30,450 | $39,347 | | **Total assets** | **$30,468** | **$39,372** | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $8,666 | $8,046 | | Total liabilities | $11,570 | $11,063 | | Total stockholders' equity | $18,898 | $28,309 | | **Total liabilities and stockholders' equity** | **$30,468** | **$39,372** | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For Q2 and H1 2023, the company reported increased net losses of **$4.3 million** and **$10.0 million**, respectively, primarily driven by higher research and development expenses Condensed Consolidated Statements of Operations (unaudited, in thousands) | | Three Months Ended June 30, | Six Months Ended June 30, | | :--- | :--- | :--- | :--- | :--- | | | **2023** | **2022** | **2023** | **2022** | | Revenue | $57 | $57 | $113 | $113 | | Research and development | $2,456 | $2,038 | $6,536 | $4,040 | | General and administrative | $2,211 | $2,139 | $4,324 | $4,325 | | **Loss from operations** | **($4,610)** | **($4,120)** | **($10,747)** | **($8,252)** | | **Net loss** | **($4,250)** | **($4,024)** | **($10,025)** | **($8,146)** | | Net loss per share, basic and diluted | ($0.20) | ($0.19) | ($0.48) | ($0.39) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For H1 2023, net cash used in operating activities increased to **$9.0 million**, resulting in a decrease of cash and cash equivalents from **$38.8 million** to **$29.7 million** Condensed Consolidated Statements of Cash Flows (unaudited, in thousands) | | Six Months Ended June 30, | | :--- | :--- | :--- | | | **2023** | **2022** | | Net cash used in operating activities | $(9,033) | $(8,510) | | Net decrease in cash and cash equivalents | $(9,028) | $(8,537) | | Cash and cash equivalents at beginning of period | $38,757 | $55,070 | | **Cash and cash equivalents at end of period** | **$29,729** | **$46,533** | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) These notes detail the company's accounting policies, business nature, and key financial disclosures, including going concern issues and revenue recognition - The company is a clinical-stage biopharmaceutical firm focused on cancer treatments, with two main clinical programs: narazaciclib (a multi-kinase inhibitor) and oral rigosertib[14](index=14&type=chunk) - The company has incurred recurring operating losses since inception, with an accumulated deficit of **$473.7 million** as of June 30, 2023. Management has concluded that substantial doubt exists about the company's ability to continue as a going concern, as current cash is only sufficient to fund operations into the second quarter of 2024[15](index=15&type=chunk)[16](index=16&type=chunk) - All revenue for the three and six months ended June 30, 2023 and 2022, was derived from the license and collaboration agreement with SymBio[28](index=28&type=chunk) Stock-Based Compensation Expense (in thousands) | | Three Months Ended June 30, | Six Months Ended June 30, | | :--- | :--- | :--- | :--- | :--- | | | **2023** | **2022** | **2023** | **2022** | | General and administrative | $168 | $72 | $334 | $259 | | Research and development | $105 | $169 | $275 | $278 | | **Total** | **$273** | **$241** | **$609** | **$537** | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition, operational results, and outlook, emphasizing clinical program progress, increased R&D, and ongoing going concern issues [Overview](index=22&type=section&id=Overview) Onconova, a clinical-stage biopharmaceutical company, faces substantial doubt about its going concern ability due to recurring losses and limited cash runway into Q2 2024 - The company's two clinical-stage programs are narazaciclib (a multi-targeted kinase inhibitor) and rigosertib (for various cancers)[61](index=61&type=chunk) - As of June 30, 2023, the company had an accumulated deficit of **$473.7 million** and cash and cash equivalents of **$29.7 million**[62](index=62&type=chunk)[63](index=63&type=chunk) - Management believes current cash is sufficient to fund operations only into the second quarter of 2024, which raises substantial doubt about the company's ability to continue as a going concern[63](index=63&type=chunk) [Product Candidates / Compounds](index=24&type=section&id=Product%20Candidates%20%2F%20Compounds) This section details the company's key product candidates, narazaciclib and rigosertib, highlighting their clinical trial progress and potential indications - **Narazaciclib:** A multi-kinase inhibitor differentiated from other CDK4/6 inhibitors by also targeting ARK5 and CSF1R. It is being developed in partnership with HanX in China, where a Phase 1 study is ongoing[66](index=66&type=chunk)[69](index=69&type=chunk)[77](index=77&type=chunk) - **Narazaciclib Clinical Trials:** A complementary U.S. Phase 1 study in advanced cancers is ongoing, with the sixth dose cohort currently enrolling. A new Phase 1/2a trial in combination with letrozole for low-grade endometrioid endometrial cancer (LGEEC) began dosing patients in May 2023[79](index=79&type=chunk)[100](index=100&type=chunk) - **Rigosertib in RDEB-SCC:** An investigator-initiated study in patients with recessive dystrophic epidermolysis bullosa-associated squamous cell carcinoma (RDEB-SCC) has shown encouraging results, including a sustained complete remission in one patient. The company met with the FDA and plans to design a registrational trial for this indication[104](index=104&type=chunk)[107](index=107&type=chunk)[108](index=108&type=chunk) - **Rigosertib in KRAS-Mutated Cancers:** An investigator-initiated Phase 1/2a study is exploring oral rigosertib in combination with nivolumab for patients with checkpoint inhibitor-resistant, KRAS-mutated non-small cell lung cancer (NSCLC)[101](index=101&type=chunk) [Results of Operations](index=35&type=section&id=Results%20of%20Operations) Revenue remained flat, while increased R&D expenses, particularly for narazaciclib, led to higher net losses of **$4.3 million** for Q2 and **$10.0 million** for H1 2023 Comparison of Three Months Ended June 30, 2023 and 2022 (in thousands) | | **2023** | **2022** | **Change** | | :--- | :--- | :--- | :--- | | Revenue | $57 | $57 | $— | | General and administrative | $2,211 | $2,139 | ($72) | | Research and development | $2,456 | $2,038 | ($418) | | **Loss from operations** | **($4,610)** | **($4,120)** | **($490)** | | **Net loss** | **($4,250)** | **($4,024)** | **($226)** | - For Q2 2023, R&D expenses increased by **$0.4 million** (21%) due to higher clinical development and manufacturing costs for narazaciclib[114](index=114&type=chunk) Comparison of Six Months Ended June 30, 2023 and 2022 (in thousands) | | **2023** | **2022** | **Change** | | :--- | :--- | :--- | :--- | | Revenue | $113 | $113 | $— | | Research and development | $6,536 | $4,040 | ($2,496) | | **Loss from operations** | **($10,747)** | **($8,252)** | **($2,495)** | | **Net loss** | **($10,025)** | **($8,146)** | **($1,879)** | - For the six months ended June 30, 2023, R&D expenses increased by **$2.5 million** (62%), primarily due to a **$1.7 million** increase in clinical development and a **$0.9 million** increase in manufacturing costs for narazaciclib[119](index=119&type=chunk) [Liquidity and Capital Resources](index=40&type=section&id=Liquidity%20and%20Capital%20Resources) With **$29.7 million** in cash as of June 30, 2023, the company faces critical liquidity issues, projecting funds only into Q2 2024, raising substantial doubt about its going concern ability - At June 30, 2023, the company had cash and cash equivalents of **$29.7 million** and an accumulated deficit of **$473.7 million**[125](index=125&type=chunk) - The company believes its cash will only be sufficient to fund operations into the second quarter of 2024, leading to substantial doubt about its ability to continue as a going concern[125](index=125&type=chunk) - The company plans to explore various dilutive and non-dilutive funding sources to alleviate the going concern issue, but there is no assurance of success[126](index=126&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=28&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Onconova Therapeutics, Inc. is not required to provide this information - The Company is not required to provide this information as it qualifies as a smaller reporting company[135](index=135&type=chunk) [Controls and Procedures](index=29&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded the company's disclosure controls and procedures were effective as of June 30, 2023, with no material changes to internal controls during the quarter - Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2023[136](index=136&type=chunk) - No material changes to the company's internal control over financial reporting occurred during the fiscal quarter ended June 30, 2023[137](index=137&type=chunk) [PART II — OTHER INFORMATION](index=30&type=section&id=PART%20II%20%E2%80%94%20OTHER%20INFORMATION) [Legal Proceedings](index=30&type=section&id=Item%201.%20Legal%20Proceedings) The company is not a party to any pending material legal proceedings, nor is it aware of any contemplated by governmental authorities - The company is not party to any pending material legal proceedings[139](index=139&type=chunk) [Risk Factors](index=30&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risk of delisting from Nasdaq due to potential non-compliance with continued listing requirements, particularly the minimum bid price rule - A significant risk is the potential failure to comply with Nasdaq's continued listing requirements, particularly the minimum bid price rule[141](index=141&type=chunk) - The company has a history of non-compliance with Nasdaq's minimum bid price and minimum stockholders' equity requirements. The closing price on August 11, 2023, was **$0.96**[142](index=142&type=chunk) - Delisting from Nasdaq could impair the stock's liquidity and the company's ability to raise capital[143](index=143&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=30&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This item is reported as not applicable for the period - Not applicable[145](index=145&type=chunk) [Exhibits](index=31&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including required certifications and XBRL data files - The report includes certifications from the Principal Executive Officer and Principal Financial Officer as required by Rule 13a-14(a)/15d-14(a) and Section 1350[146](index=146&type=chunk)

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-36020 Onconova Therapeutics, Inc. (Exact name of registrant as specified in its charter) | --- | |--------------------------------------| | | | | ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K (Mark one) ⌧ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-36020 Onconova Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware (State or other j ...