Group 1 - Traws Pharma, Inc. has announced a financing agreement to raise up to $72.6 million, which includes an initial tranche of $20 million and a subsequent tranche of up to $52.6 million, aimed at extending its cash runway into the first half of 2026 and beyond [1][2] - The financing will support the development of Tivoxavir Marboxil, a drug candidate designed to treat respiratory viral diseases, including bird flu, with significant potential in the antiviral market [2][9] - The initial tranche will be funded through the issuance of 3,919,249 shares of common stock and pre-paid warrants, with additional funds available upon the exercise of non-prepaid warrants [1] Group 2 - The company is expecting key data readouts in early 2025 related to Ferret Bird Flu and Non-Human Primate Bird Flu, as well as Phase 2A data anticipated in the second half of 2025 [1] - Traws Pharma has received support from notable institutional investors, indicating strong confidence in the company's potential and the transformative nature of this financing [2] - The company plans to host an update call regarding Tivoxavir Marboxil in the first quarter of 2025, providing further insights into its development [14] Group 3 - The H5N1 bird flu virus has been confirmed in at least 866 herds across 16 states in the U.S., with over 60 human infections reported, highlighting the urgency for effective treatments [8][13] - Tivoxavir Marboxil has shown potent in vitro activity against various influenza strains, including highly pathogenic avian flu, and may enable a single-dose prophylaxis regimen [9][13] - The financing and ongoing development efforts are crucial as health officials warn of the rising potential for epidemic or pandemic spread of bird flu [13]

Core Insights - Traws Pharma is developing tivoxavir marboxil as a potential treatment for H5N1 bird flu, demonstrating safety and tolerability in Phase 1 trials, with drug levels maintained above the effective concentration for over 23 days [3][5][15] - The company plans to initiate a Phase 2 study in the first half of 2025, responding to the increasing risk of avian influenza adapting to humans [4][10] - The emergence of H5N1 in U.S. dairy cattle has raised concerns, with over 60 human infections reported, highlighting the urgency for effective treatments [10] Company Overview - Traws Pharma, Inc. is a clinical-stage biopharmaceutical company focused on developing oral small molecule therapies for respiratory viral diseases, including influenza and COVID-19 [11] - The company is committed to addressing unmet medical needs through innovative drug development technologies [11] Product Development - Tivoxavir marboxil has shown potent inhibition of drug-resistant influenza viruses and highly pathogenic avian flu viruses in both in vitro and in vivo studies [5][15] - The drug's pharmacokinetic profile supports the potential for a single-dose treatment regimen, which could be significant for pandemic preparedness [15] Market Opportunity - The seasonal influenza market represents a multi-billion dollar opportunity, driven by global health initiatives and government tenders, with additional potential from pandemic flu scenarios [6]

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) | --- | --- | |-------------------------------------------------- ...

Table of Contents | --- | --- | --- | |---------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------| | | UNITED STATES SEC ...

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].

[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)