$TRAW
Traws Pharma, Inc.

2021 Q4 Form 10-Q Financial Statement

#000155837021016043 Filed on November 15, 2021

View on sec.gov

Income Statement

Concept 2021 Q4 2021 Q3 2020 Q3
Revenue $56.00K $57.00K $66.00K
YoY Change -6.67% -13.64% 10.0%
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $2.074M $2.284M $2.150M
YoY Change 16.52% 6.23% 31.1%
% of Gross Profit
Research & Development $1.745M $1.763M $4.193M
YoY Change -61.48% -57.95% 19.12%
% of Gross Profit
Depreciation & Amortization $4.000K $3.000K $0.00
YoY Change
% of Gross Profit
Operating Expenses $3.819M $4.047M $6.340M
YoY Change -39.48% -36.17% 22.87%
Operating Profit -$3.990M -$6.274M
YoY Change -36.4%
Interest Expense $0.00 $530.0K $60.00K
YoY Change -100.0% 783.33% -87.5%
% of Operating Profit
Other Income/Expense, Net -$1.000K $7.000K -$23.00K
YoY Change -96.67% -130.43% -176.67%
Pretax Income -$3.764M -$3.453M -$6.240M
YoY Change -41.46% -44.66% 35.65%
Income Tax $0.00
% Of Pretax Income
Net Earnings -$3.764M -$3.453M -$6.241M
YoY Change -41.46% -44.67% 35.67%
Net Earnings / Revenue -6721.43% -6057.89% -9456.06%
Basic Earnings Per Share -$0.22
Diluted Earnings Per Share -$179.8K -$216.1K -$517.4K
COMMON SHARES
Basic Shares Outstanding 20.89M 15.78M
Diluted Shares Outstanding 15.98M

Balance Sheet

Concept 2021 Q4 2021 Q3 2020 Q3
SHORT-TERM ASSETS
Cash & Short-Term Investments $55.07M $59.38M $24.20M
YoY Change 189.84% 145.36% 404.17%
Cash & Equivalents $55.07M $59.38M $24.20M
Short-Term Investments
Other Short-Term Assets $35.00K $97.00K $800.0K
YoY Change -80.56% -87.88% -20.0%
Inventory
Prepaid Expenses
Receivables $28.00K $29.00K $0.00
Other Receivables $0.00 $0.00 $0.00
Total Short-Term Assets $55.43M $59.94M $25.00M
YoY Change 180.18% 139.74% 331.03%
LONG-TERM ASSETS
Property, Plant & Equipment $38.00K $42.00K $100.0K
YoY Change -26.92% -58.0% 0.0%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $10.00K $12.00K $200.0K
YoY Change -93.33% -94.0% 0.0%
Total Long-Term Assets $48.00K $54.00K $200.0K
YoY Change -76.24% -73.0% 0.0%
TOTAL ASSETS
Total Short-Term Assets $55.43M $59.94M $25.00M
Total Long-Term Assets $48.00K $54.00K $200.0K
Total Assets $55.48M $59.99M $25.20M
YoY Change 177.58% 138.06% 320.0%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $2.757M $4.050M $5.700M
YoY Change -42.95% -28.95% 26.67%
Accrued Expenses $3.132M $2.749M $3.100M
YoY Change -36.88% -11.32% -3.13%
Deferred Revenue $226.0K $226.0K
YoY Change 0.0%
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $6.115M $7.025M $9.300M
YoY Change -38.98% -24.46% 13.41%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00 $0.00
YoY Change
Other Long-Term Liabilities $3.243M $3.299M $3.700M
YoY Change -14.66% -10.84% -2.63%
Total Long-Term Liabilities $3.243M $3.299M $3.700M
YoY Change -14.66% -10.84% -2.63%
TOTAL LIABILITIES
Total Short-Term Liabilities $6.115M $7.025M $9.300M
Total Long-Term Liabilities $3.243M $3.299M $3.700M
Total Liabilities $9.358M $10.32M $13.00M
YoY Change -32.24% -20.58% 8.33%
SHAREHOLDERS EQUITY
Retained Earnings -$444.7M -$441.0M
YoY Change 3.77%
Common Stock $490.9M $490.6M
YoY Change 12.91%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $46.12M $49.67M $12.20M
YoY Change
Total Liabilities & Shareholders Equity $55.48M $59.99M $25.20M
YoY Change 177.58% 138.06% 320.0%

Cashflow Statement

Concept 2021 Q4 2021 Q3 2020 Q3
OPERATING ACTIVITIES
Net Income -$3.764M -$3.453M -$6.241M
YoY Change -41.46% -44.67% 35.67%
Depreciation, Depletion And Amortization $4.000K $3.000K $0.00
YoY Change
Cash From Operating Activities -$4.265M -$4.267M -$5.770M
YoY Change -22.03% -26.05% 45.71%
INVESTING ACTIVITIES
Capital Expenditures $0.00 $0.00 $0.00
YoY Change -100.0%
Acquisitions
YoY Change
Other Investing Activities
YoY Change
Cash From Investing Activities $0.00 $0.00 $0.00
YoY Change -100.0%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net $19.50M
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities -35.00K 19.94M 2.720M
YoY Change -112.5% 633.24% -8.42%
NET CHANGE
Cash From Operating Activities -4.265M -4.267M -5.770M
Cash From Investing Activities 0.000 0.000 0.000
Cash From Financing Activities -35.00K 19.94M 2.720M
Net Change In Cash -4.300M 15.68M -3.050M
YoY Change -17.15% -614.0% 190.48%
FREE CASH FLOW
Cash From Operating Activities -$4.265M -$4.267M -$5.770M
Capital Expenditures $0.00 $0.00 $0.00
Free Cash Flow -$4.265M -$4.267M -$5.770M
YoY Change -22.03% -26.05% 47.95%

Facts In Submission

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<p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><b style="font-weight:bold;">1. Nature of Business</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-weight:bold;visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><b style="font-weight:bold;">The Company</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt;"><span style="visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt;">Onconova Therapeutics, Inc. (the “Company”) was incorporated in the State of Delaware on December 22, 1998 and commenced operations on January 1, 1999. The Company’s headquarters are located in Newtown, Pennsylvania. The Company is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation. The Company believes that the product candidates in its pipeline have the potential to be efficacious in a variety of cancers with unmet medical need. The Company has the following two clinical-stage programs: 1. narazaciclib (ON 123300), a multi-kinase inhibitor in solid tumors; and 2. oral rigosertib alone or in combination with PD-1 inhibitors for treatment of KRAS-mutated solid tumors. During 2012, Onconova Europe GmbH was established as a wholly owned subsidiary of the Company for the purpose of further developing business in Europe.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt;"><span style="visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt;">The Company has entered into several license and collaboration agreements. In 2011, the Company entered into a license agreement, as subsequently amended, with SymBio Pharmaceuticals Limited (“SymBio”), which grants SymBio certain rights to commercialize rigosertib in Japan and Korea. In December 2017, the Company entered into a license and collaboration agreement with HanX Biopharmaceuticals, Inc. (“HanX”) for the further development, registration and commercialization of narazaciclib in greater China. Narazaciclib is a preclinical compound which the Company believes has the potential to overcome the limitations of current generation CDK 4/6 inhibitors. Under the terms of the agreement, the Company received an upfront payment, and will receive regulatory and commercial milestone payments, as well as royalties on Chinese sales. The key feature of the collaboration is that HanX provides all funding required for Chinese IND enabling studies performed for Chinese Food and Drug Administration IND approval, which was received in January 2020. The Company and HanX also intended for these studies to comply with the FDA standards for IND approval. Accordingly, such studies were used by the Company for an IND filing with the US FDA in November 2020. The FDA Study May Proceed letter was issued in December 2020. The Company maintains global rights outside of China. On March 2, 2018, the Company entered into a License, Development and Commercialization Agreement (the “Pint License Agreement”) with Pint International SA (which, together with its affiliate Pint Pharma GmbH, are collectively referred to as “Pint”). Under the terms of the agreement, the Company granted Pint an exclusive, royalty-bearing license, with the right to sublicense, under certain Company patent rights and know-how, to develop and commercialize any pharmaceutical product containing rigosertib in all uses of rigosertib in certain Latin American countries. In May 2019, the Company entered into a License and Collaboration Agreement (the “HanX License Agreement”) with HanX. Under the terms of the HanX License Agreement, the Company granted HanX an exclusive, royalty-bearing license, with the right to sublicense, under certain Company patent rights and know-how, to develop and commercialize any pharmaceutical product (the “HanX Product”) containing rigosertib in all uses of rigosertib or the HanX Product in human therapeutic uses in the People’s Republic of China, Hong Kong, Macau and Taiwan (the “HanX Territory”). In connection with the HanX License Agreement, the Company also entered into a Securities Purchase Agreement with each of HanX and Abundant New Investments Ltd. (“Abundant”), an affiliate of HanX (each, a “Securities Purchase Agreement” and together, the “Securities Purchase Agreements”). HanX did not fulfill its obligations under the HanX License Agreement and in January 2020, in accordance with the terms of the HanX License Agreement, the HanX License Agreement was deemed to be void ab initio. Upon this termination, the rights to HanX Product in the HanX Territory reverted to the Company in accordance with the terms of the HanX License Agreement. In addition, the Securities Purchase Agreements terminated automatically effective upon the termination of the HanX License Agreement in accordance with the Securities Purchase Agreements. In November 2019, the Company entered into a Distribution, License and Supply Agreement (the “Knight License Agreement”) with Knight Therapeutics Inc. (“Knight”). Under the terms of the Knight License Agreement, the Company granted Knight (i) a non-exclusive, royalty-bearing license, with the right to sublicense, under certain Company patent rights and know-how, to develop and manufacture any product (the “Knight Licensed Product”) containing rigosertib for Canada (and Israel, should Knight exercise its option as set forth in the Knight License Agreement) (the “Knight Territory”) and in human uses (the </p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">“Field”), and (ii) an exclusive, royalty-bearing license, with the right to sublicense, under certain Company patent rights and know-how, to commercialize the Knight Licensed Product in the Knight Territory and in the Field. Knight has also agreed to obtain from the Company all of its requirements of the Knight Licensed Products for the Knight Territory, and the Company has agreed to supply Knight with all of its requirements of the Knight Licensed Products. In December 2019, the Company entered into a Distribution, License and Supply Agreement (the “STA License Agreement”) with Specialised Therapeutics Asia Pte. Ltd. (“STA”). Under the terms of the STA License Agreement, the Company granted STA (i) a non-exclusive, royalty -bearing license, with the right to sublicense, under certain Company patent rights and know-how, to develop and manufacture any product (the “STA Licensed Product”) containing rigosertib for Australia and New Zealand (the “STA Territory”) and in human uses (the “Field”), and (ii) an exclusive, royalty-bearing license, with the right to sublicense, under certain Company patent rights and know- how, to commercialize the STA Licensed Product in the STA Territory and in the Field. STA has also agreed to obtain from the Company all of its requirements of the STA Licensed Products for the STA Territory, and the Company has agreed to supply STA with all of its requirements of the STA Licensed Products.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt;"><span style="visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:31.9pt;margin:0pt;">On May 20, 2021, the Company amended its certificate of incorporation to effect a <span style="-sec-ix-hidden:Hidden_k7XeF_Z0PEm5g4RkKAxSDQ;"><span style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-style:normal;font-weight:normal;text-align:left;">one-for-fifteen</span></span> reverse stock split of its common stock. All common stock, equity, share and per share amounts in the financial statements and notes have been retroactively adjusted to reflect this <span style="-sec-ix-hidden:Hidden_ETOwmjPm1EGc-Si1Tc1qyA;"><span style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-style:normal;font-weight:normal;text-align:left;">one-for-fifteen</span></span> reverse stock split.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt;"><span style="visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt;">On May 20, 2021, the Company amended its certificate of incorporation to decrease the number of authorized shares of common stock par value $0.01 per share from 250,000,000 to 125,000,000. </p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt;"> <span style="visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><b style="font-weight:bold;">Liquidity</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt;">The Company has incurred recurring operating losses since inception. For the nine months ended September 30, 2021, the Company incurred a net loss of $12,399,000 and as of September 30, 2021 the Company had generated an accumulated deficit of $440,955,000. The Company anticipates operating losses to continue for the foreseeable future due to, among other things, costs related to research, development of its product candidates and its preclinical programs, strategic alliances and its administrative organization. At September 30, 2021, the Company had cash and cash equivalents of $59,378,000. The Company will require substantial additional financing to fund its ongoing clinical trials and operations, and to continue to execute its strategy.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt;">On January 11, 2021, the Company closed on an offering of common stock. The Company issued 1,303,408 shares of common stock and net proceeds were approximately $8.5 million. On February 16, 2021, the Company closed on an offering of common stock. The Company issued 1,916,667 shares of common stock and net proceeds were approximately $26.7 million. On September 28, 2021, the Company closed on an offering of common stock. The Company issued 5,000,000 shares of common stock and net proceeds were approximately $19.5 million.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt;"><span style="visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt;">On August 20, 2021, the Company entered into an at-the-market equity distribution agreement for the sale of up to $25.0 million of common stock. Through September 30, 2021, the Company sold 109,523 shares under the agreement at a weighted average price of $5.32 per share. Net proceeds after commissions and offering expenses were approximately $0.5 million.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt;">Following the unsuccessful conclusion of the INSPIRE trial, the Company has taken steps to reduce its cash expenditures. From September 2020 to December 2020, the Company implemented a workforce reduction of employees in research and development who were primarily focused on preparing the NDA for the use of rigosertib in higher risk MDS. In total, 10 employees were terminated, representing approximately 43% of the Company’s workforce. A severance related charge of approximately $1,207,000, which includes a non-cash charge of approximately $29,000 related to the accelerated vesting of outstanding stock options, was recorded in the year ended December 31, 2020. The accrued severance balance was included in accrued expenses and other liabilities on the balance sheet. It was paid in </p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">periodic amounts through September 2021. On October 30, 2020, the Company notified its landlord of its intention to not renew its office space lease. The lease expired in February 2021 and was modified to a month-to-month lease for a portion of the space. The lease terminated in June 2021 and the Company has relocated to temporary office space with all employees working remotely.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt;">The Company has and may continue to delay, scale-back, or eliminate certain of its research and development activities and other aspects of its operations until such time as the Company is successful in securing additional funding. The Company is exploring various dilutive and non-dilutive sources of funding, including equity financings, strategic alliances, business development and other sources. The future success of the Company is dependent upon its ability to obtain additional funding. There can be no assurance, however, that the Company will be successful in obtaining such funding in sufficient amounts, on terms acceptable to the Company, or at all. The Company believes that its cash and cash equivalents will be sufficient to fund its ongoing trials and business operations for more than twelve months from the date of this filing.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><b style="font-weight:bold;">COVID-19</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt;">While the Company is not aware of a material impact from the novel coronavirus disease (“COVID-19”) pandemic through September 30, 2021, the full extent to which COVID-19 will directly or indirectly impact the Company’s business, results of operations and financial condition, including manufacturing, clinical trials and research and development costs, depends on future developments that are highly uncertain at this time.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt;"><span style="font-size:1pt;visibility:hidden;">​</span></p>
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