Traws Pharma, Inc.(TRAW) - 2018 Q4 - Annual Report

Part I Business Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule cancer therapies, with rigosertib as its lead product candidate in a Phase 3 trial for higher-risk myelodysplastic syndromes - The company's primary focus is on its lead product candidate, rigosertib, which is in a pivotal Phase 3 clinical trial (INSPIRE) for higher-risk myelodysplastic syndromes (MDS) after failure of hypomethylating agent (HMA) therapy[20][21] - The INSPIRE trial, a randomized controlled Phase 3 study of intravenous rigosertib, had its enrollment target increased from 225 to 360 patients following a pre-planned interim analysis in January 2018, with enrollment over 75% complete as of March 2019 and expected to be fully enrolled in the second half of 2019[37][38][40] - The company has two other clinical-stage candidates: Briciclib, for which the IND is on full clinical hold, and Recilisib, for acute radiation syndromes, whose future development depends on government funding or collaboration[63][64] Research and Development Expenses (2016-2018) | Year | R&D Expense (in millions) | | :--- | :--- | | 2018 | $16.9 | | 2017 | $19.1 | | 2016 | $20.1 | - Onconova has established key strategic collaborations to commercialize its products outside the U.S., including with SymBio for rigosertib in Japan and Korea, Pint Pharma for rigosertib in Latin America, and HanX for ON 123300 in China[71][78][83] - As of December 31, 2018, the company had 25 employees, with a planned reduction to 19 employees in March 2019 to conserve cash[199][201] Risk Factors The company faces significant risks, primarily related to its financial position and need for capital, with substantial doubt about its ability to continue as a going concern - The company's auditors have expressed substantial doubt about its ability to continue as a going concern due to ongoing operating losses and the need to raise additional capital to fund operations, including the INSPIRE trial[204][205] - The company has incurred significant losses since inception, with a net loss of $20.4 million in 2018 and an accumulated deficit of $381.9 million as of December 31, 2018[208] - Future success is almost entirely dependent on the regulatory approval and successful commercialization of a single late-stage product candidate, rigosertib, where failure in clinical trials or to gain approval would substantially harm the business[215][216] - The company relies on third-party CROs to conduct clinical trials and CMOs for manufacturing, creating risks related to performance, regulatory compliance (cGMP, GCP), and potential supply chain disruptions[306][311] - The company has previously failed to comply with Nasdaq's minimum stockholders' equity and minimum bid price requirements, and future non-compliance could result in delisting[344][345][346] Unresolved Staff Comments The company reports that it has no unresolved staff comments from the Securities and Exchange Commission - There are no unresolved staff comments[371] Properties The company leases approximately 9,500 square feet of office and laboratory space in Newtown, Pennsylvania, which it deems adequate for its near-term needs - The company's principal executive offices and research facilities are located in a leased space of approximately 9,500 square feet in Newtown, Pennsylvania[372] Legal Proceedings The company is not currently a party to any legal proceedings and is unaware of any contemplated by government authorities - The company is not a party to any legal proceedings[374] Mine Safety Disclosures This item is not applicable to the company's business - Not applicable[375] Part II Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities The company's common stock trades on the Nasdaq Capital Market under "ONTX", with no history or future plans for cash dividends - The company's common stock is listed on the Nasdaq Capital Market under the symbol "ONTX"[378] - The company has never declared or paid cash dividends and does not plan to do so in the foreseeable future[381] Selected Financial Data As a smaller reporting company, Onconova is exempt from providing the information for this item - The company is exempt from this disclosure requirement as a smaller reporting company[382] Management's Discussion and Analysis of Financial Condition and Results of Operations In 2018, Onconova's revenue increased to $1.2 million, operating expenses decreased to $24.5 million, and the net loss improved to $20.4 million, but cash of $17.0 million is projected to fund operations only into Q4 2019, raising going concern doubts Financial Performance Summary (2017 vs. 2018) | Metric | 2018 | 2017 | | :--- | :--- | :--- | | Revenue | $1,228,000 | $787,000 | | Total Operating Expenses | $24,510,000 | $26,524,000 | | Research and Development | $16,924,000 | $19,119,000 | | General and Administrative | $7,586,000 | $7,405,000 | | Net Loss | ($20,410,000) | ($24,092,000) | - The increase in 2018 revenue was primarily due to the recognition of license fees from new agreements with HanX ($450,000) and Pint ($319,000)[399][438] - The decrease in R&D expenses in 2018 was driven by a $2.0 million reduction in clinical and consulting expenses (including $1.4 million lower spending on the INSPIRE trial) and a $0.8 million decrease in manufacturing costs[440][441] - As of December 31, 2018, the company had $17.0 million in cash and cash equivalents, which is expected to fund operations into Q4 2019, contributing to substantial doubt about its ability to continue as a going concern[392][444][453] - Net cash used in operating activities was $22.7 million in 2018, compared to $23.8 million in 2017, while net cash from financing activities was $35.7 million in 2018, primarily from stock and warrant sales, a significant increase from $6.4 million in 2017[445][446][451] Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, Onconova is exempt from providing the information for this item - The company is exempt from this disclosure requirement as a smaller reporting company[463] Financial Statements and Supplementary Data This section refers to the full consolidated financial statements and supplementary data, which are detailed in Item 15 of the report - The financial statements required by this item are listed in Item 15 of the Annual Report[464] Changes in and Disagreements With Accountants on Accounting and Financial Disclosure The company reports no changes in or disagreements with its accountants on accounting and financial disclosure - None reported[465] Controls and Procedures Management concluded that the company's disclosure controls and procedures and internal control over financial reporting were effective as of December 31, 2018 - Management concluded that as of December 31, 2018, the company's disclosure controls and procedures were effective[466] - Management concluded that as of December 31, 2018, the company's internal control over financial reporting was effective[467] Other Information The company reports no other information for this item - None reported[470] Part III Directors, Executive Officers and Corporate Governance Information regarding directors, executive officers, and corporate governance is incorporated by reference from the company's 2019 Annual Meeting Proxy Statement - Information is incorporated by reference from the 2019 Proxy Statement[473] Executive Compensation Information regarding executive and director compensation is incorporated by reference from the company's 2019 Annual Meeting Proxy Statement - Information is incorporated by reference from the 2019 Proxy Statement[474] Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters Information regarding security ownership of major shareholders and management is incorporated by reference from the company's 2019 Annual Meeting Proxy Statement - Information is incorporated by reference from the 2019 Proxy Statement[475] Certain Relationships and Related Transactions, and Director Independence Information regarding related party transactions and director independence is incorporated by reference from the company's 2019 Annual Meeting Proxy Statement - Information is incorporated by reference from the 2019 Proxy Statement[476] Principal Accounting Fees and Services Information regarding fees paid to the principal accountant and services rendered is incorporated by reference from the company's 2019 Annual Meeting Proxy Statement - Information is incorporated by reference from the 2019 Proxy Statement[477] Part IV Exhibits and Financial Statement Schedules This section provides an index of the financial statements and all exhibits filed as part of the Form 10-K, including corporate documents and certifications - This item lists the financial statements and exhibits filed with the report[480] Financial Statements Report of Independent Registered Public Accounting Firm The auditor, Ernst & Young LLP, issued an opinion that the consolidated financial statements are presented fairly, but highlighted substantial doubt about the company's ability to continue as a going concern - The auditor's report contains a "going concern" paragraph, indicating substantial doubt about the company's ability to continue operations due to recurring losses[498] Consolidated Financial Statements The consolidated financial statements for 2018 and 2017 show improved financial position due to financing activities, with cash increasing to $17.0 million and stockholders' equity turning positive, despite a net loss of $20.4 million in 2018 Key Balance Sheet Data (as of Dec 31) | Metric | 2018 | 2017 | | :--- | :--- | :--- | | Cash and cash equivalents | $16,970,000 | $4,024,000 | | Total Assets | $17,923,000 | $4,979,000 | | Total Liabilities | $12,536,000 | $15,840,000 | | Total Stockholders' Equity (Deficit) | $5,387,000 | ($10,861,000) | Key Operations Data (Year Ended Dec 31) | Metric | 2018 | 2017 | | :--- | :--- | :--- | | Revenue | $1,228,000 | $787,000 | | Loss from Operations | ($23,282,000) | ($25,737,000) | | Net Loss | ($20,410,000) | ($24,092,000) | | Net Loss Per Share | ($4.99) | ($40.15) | Key Cash Flow Data (Year Ended Dec 31) | Metric | 2018 | 2017 | | :--- | :--- | :--- | | Net cash used in operating activities | ($22,696,000) | ($23,820,000) | | Net cash provided by financing activities | $35,657,000 | $6,360,000 | | Net increase (decrease) in cash | $12,946,000 | ($17,426,000) | Notes to Consolidated Financial Statements The notes detail a one-for-fifteen reverse stock split, management's going concern doubt due to limited cash, revenue sources from license agreements, significant tax assets offset by a valuation allowance, and subsequent events including a CEO change and workforce reduction - All share and per-share amounts have been retroactively adjusted to reflect a one-for-fifteen reverse stock split effective September 25, 2018[517][522] - Management concludes there is substantial doubt about the company's ability to continue as a going concern, as cash and cash equivalents of $17.0 million at year-end 2018 are only sufficient to fund operations into Q4 2019[523][528] - The company adopted the new revenue recognition standard ASC 606 on January 1, 2018, with no material impact, and revenue is derived from license and collaboration agreements[544][547] - As of December 31, 2018, the company had significant tax assets, including federal net operating loss (NOL) carryforwards of $232 million and state NOLs of $188 million, which are fully offset by a valuation allowance[597] - Subsequent to year-end, in January 2019, Stephen Fruchtman, M.D. was appointed CEO, succeeding Ramesh Kumar, Ph.D., and in March 2019, the company initiated a workforce reduction affecting six employees to conserve cash[683][690]