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 ...

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 September 30, 2022 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) Delaware 22-3627252 (State or other jurisdiction of ...

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 June 30, 2022 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) Delaware 22-3627252 (State or other jurisdiction of (I.R. ...

(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, 2022 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-36020 Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q Onconova Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 22-3627252 (State or other jurisdiction of (I.R ...

Table of Contents For the transition period from to Commission file number 001-36020 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, 2021 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Onconova Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware (State or other j ...

Financial Performance - Net losses for the nine months ended September 30, 2021, were $12.4 million compared to $18.7 million for the same period in 2020, with an accumulated deficit of $441.0 million as of September 30, 2021[110]. - Revenue for the three months ended September 30, 2021, was $57,000, a decrease of $9,000 compared to $66,000 in the same period of 2020[150]. - The net loss for the three months ended September 30, 2021, was $3,453,000, an improvement of $2,788,000 from a net loss of $6,241,000 in the same period of 2020[150]. - Revenues decreased by $9,000, or 14%, for the three months ended September 30, 2021, compared to the same period in 2020[151]. - Net cash used in operating activities was $15.2 million for the nine months ended September 30, 2021, compared to $17.6 million for the same period in 2020[170]. - Net cash provided by financing activities was $55.6 million for the nine months ended September 30, 2021, compared to $19.1 million for the same period in 2020[175]. - The accumulated deficit at September 30, 2021, was $441.0 million[168]. Cash and Financing - As of September 30, 2021, the company had $59.4 million in cash and cash equivalents, expected to fund operations and ongoing trials for more than two years[114]. - The company raised approximately $8.5 million from a common stock offering on January 12, 2021, and approximately $26.7 million from another offering on February 16, 2021[111]. - An at-the-market equity distribution agreement was entered on August 20, 2021, allowing for the sale of up to $25.0 million in common stock, with net proceeds of approximately $0.5 million from 109,523 shares sold by September 30, 2021[112]. - The company is exploring various funding sources for ongoing operations and development, emphasizing the need for additional financing to continue its clinical-stage programs[115]. - The company expects net cash expenditures in 2022 to be comparable to 2021, primarily due to ongoing clinical trials[177]. Research and Development - Narazaciclib (ON 123300) is a multi-kinase inhibitor targeting CDK4/6 and other tyrosine kinases, showing potential efficacy in various cancers[107]. - The IC50 values for narazaciclib against CDK4 and CDK6 are 3.87 nM and 9.82 nM, respectively, indicating its potency compared to palbociclib[118]. - A collaboration agreement with HanX for the development and commercialization of narazaciclib in China includes upfront payments, milestone payments, and royalties on future sales[122]. - The IND for narazaciclib was approved by the Chinese FDA on January 6, 2020, following a filing by HanX in the fourth quarter of 2019[124]. - Enrollment in the US Phase 1 study of narazaciclib commenced in May 2021, with 36 patients enrolled in the first cohort, showing no dose limiting toxicities[125]. - A complementary Phase 1 study for narazaciclib in China has been initiated, with the first patient enrolled on September 15, 2020, and no dose limiting toxicities observed to date[126]. - Narazaciclib is expected to provide preliminary safety data and the recommended Phase 2 dose and schedule upon completion of the Phase 1 studies[127]. - The safety profile of narazaciclib is anticipated to be similar to approved CDK4/6 inhibitors, with common adverse events including myelosuppression and gastrointestinal toxicity[137]. - Preliminary efficacy data from a study of rigosertib in combination with a PD-1 inhibitor in KRAS-mutated NSCLC showed a clinical benefit rate of 43%[141]. Operating Expenses - Total operating expenses for the three months ended September 30, 2021, were $4,047,000, down by $2,293,000 from $6,340,000 in the same period of 2020[150]. - Research and development expenses decreased by $2,430,000 to $1,763,000 for the three months ended September 30, 2021, compared to $4,193,000 in 2020[150]. - General and administrative expenses increased by $0.8 million, or 12%, to $7.4 million for the nine months ended September 30, 2021, from $6.5 million for the same period in 2020[161]. - Research and development expenses decreased by $6.8 million, or 55%, to $5.6 million for the nine months ended September 30, 2021, from $12.4 million for the same period in 2020[163]. - The change in fair value of warrant liability increased by $474,000, from $56,000 in 2020 to $530,000 in 2021[150]. - The fair value of the warrant liability decreased by $0.3 million for the nine months ended September 30, 2021, compared to an increase of $0.1 million for the same period in 2020[165].

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q 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) Delaware 22-3627252 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) 12 Penns Trail, Newtown, PA 18940 (Address of principal executive offices) (Zip Cod ...