UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-K
(Amendment No. 1)
(Mark one)
x | ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the fiscal year ended December 31, 2020
Or
¨ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period fromto
Commission file number 001-36020
Onconova Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
22-3627252 | |||
(State or other jurisdiction of | (I.R.S. Employer | ||
incorporation or organization) | Identification No.) | ||
375 Pheasant Run, Newtown, PA | 18940 | |||
(Address of principal executive offices) | (Zip Code) |
(267) 759-3680 |
(Registrant’s telephone number, including area code) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||
Common Stock, par value $.01 per share | ONTX | The Nasdaq Stock Market LLC | ||||||
Common Stock Warrants | ONTXW | The Nasdaq Stock Market LLC |
Securities registered pursuant to Section 12(g) of the Act:
NoneNone
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐¨ No ☒
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and
(2) has been subject to such filing requirements for the past 90 days. Yes ☒x No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-TS- T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒x No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”, “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer | Accelerated filer | Non-accelerated filer | Smaller reporting company x | |||||||
Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. Yes ☐¨ No ☒
Indicate by check mark whether the registrant is a shell company (as defined in Rule12b-2 of the Act). Yes ☐¨ No ☒
As of June 30, 2020, the last business day of the registrant’s most recently completed second fiscal quarter, the aggregate market value of the registrant’s voting stock held by non-affiliates was approximately $98.4 million, based on the last reported sale price of the registrant’s common stock on the Nasdaq Capital Market.
There were 236,612,391 shares of Common Stockcommon stock outstanding as of March 1, 2021.
PART III | ||||||||
Directors, Executive Officers and Corporate Governance | ||||||||
Executive Compensation | ||||||||
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | ||||||||
Certain Relationships and Related Transactions, and Director Independence | ||||||||
Principal | ||||||||
PART IV | ||||||||
Exhibits and Financial Statement Schedules | ||||||||
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EXPLANATORY NOTE REGARDING FORWARD-LOOKING STATEMENTS AND INDUSTRY DATA
Onconova Therapeutics, Inc., sometimes referred to as “we”“we,” “our,” or the “Company,“Company” is filing this Amendment No. 1 on Form 10-K/A, or this Amendment, to its Annual Report on Form 10-K for the year ended December 31, 2020, originally filed on March 18, 2021, or the “Original Report,” for the sole purpose of including the information required by Part III of Form 10-K. This information was previously omitted from the Original Report in reliance on General Instruction G(3) to Form 10-K, which permits the information in the above referenced items to be incorporated in the Form 10-K by reference from our definitive proxy statement if such statement is filed no later than 120 days after the our fiscal year-end. We are filing this Amendment to provide information required in Part III of Form 10-K because a definitive proxy statement containing such information will not be filed by the Company within 120 days after the end of the fiscal year covered by the Form 10-K.
In accordance with Rule 12b-15 under the Securities and Exchange Act of 1934, as amended, or the Exchange Act, Part III, Items 10 through 14 of the Original Report are hereby amended and restated in their entirety, and Part IV, Item 15 of the Original Report is hereby amended and restated in its entirety, with the only changes being the addition of the new certifications by our principal executive officer and principal financial officer filed herewith. This Amendment does not amend or otherwise update any other information in the Original Report. Accordingly, this Amendment should be read in conjunction with the Original Report and with our filings with the Securities and Exchange Commission subsequent to the Original Report.
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PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE.
All of our directors bring to our Board of Directors executive leadership experience from their service as executives and/or directors of our Company and/or other entities. The biography of each of the nominees below contains information regarding the person's business experience, director positions held currently or at any time during the last five years, and the experiences, qualifications, attributes and skills that caused the Nominating and Corporate Governance Committee and our Board of Directors to determine that the person should serve as a director, given our business and structure.
Name | Age | Position(s) with Onconova Therapeutics, Inc. | Served as Director From | |||||||
Jack E. Stover | 68 | Director | 2016 | |||||||
James J. Marino | 71 | Chairman of the Board of Directors | 2015 | |||||||
Jerome E. Groopman, M.D. | 69 | Director | 2013 | |||||||
Steven M. Fruchtman | 70 | Director, President and Chief Executive Officer | 2019 | |||||||
M. Teresa Shoemaker | 60 | Director | 2020 | |||||||
Viren Mehta | 71 | Director | 2004 |
Jack E. Stover. Mr. Stover has served as a member of our Board of Directors since May 2016. Since March 2021, Mr. Stover has been Chief Executive Officer of NorthView Acquisition Corp. From December 2015 until June 2016, Mr. Stover served as Interim President and CEO of Interpace Diagnostics Group, Inc. (“Interpace”) and, since August 2005, served on the Board of Directors of Interpace and was chairman of Interpace’s audit committee from August 2005 until December 2015. In June 2016 until December 2020, Mr. Stover was President, CEO and Director of Interpace, which in 2019 changed its name to Interpace Biosciences, Inc. From June 2016 to December 2016, Mr. Stover was chairman of the audit committee and a member of the Board of Directors of Viatar CTC Solutions, Inc. From 2004 to 2008, he served as Chief Executive Officer, President and Director of Antares Pharma, Inc., a publicly held specialty pharmaceutical company then listed on the American Stock Exchange and subsequently Nasdaq. In addition to other relevant experience, Mr. Stover was also formerly a partner with PricewaterhouseCoopers (then Coopers and Lybrand), working in the bioscience industry division in New Jersey. Mr. Stover received his B.A. in Accounting from Lehigh University and is a clinical-stageCertified Public Accountant.
Our Board of Directors believes that Mr. Stover's experience holding senior leadership positions in the life sciences industry, his specific experience and skills in the areas of general operations, and financial operations and administration, and his extensive experience in accounting and as an audit committee member and chair of various public companies in the life sciences industry, provide him with the qualifications and skills to serve as a director.
James J. Marino. Mr. Marino has served as Chairman of the Board of Directors since August 2020 and as a member of our Board of Directors since July 2015. Prior to July 2015, Mr. Marino was a Partner at the global law firm of Dechert LLP for 28 years, where he served as Managing Partner of the Princeton Office. Mr. Marino served as the outside counsel for the Company from its inception through and including its initial public offering. On March 8, 2017, Mr. Marino was appointed to the Board of Directors and as chairperson of the compensation committee of Celldex Therapeutics, Inc., a public company which is developing targeted therapeutics to address devastating diseases for which available treatments are inadequate. Previously, he served on the Board of Directors of Pharmacopeia Drug Discovery, Inc. from 2000 to 2006 and has worked in advisory capacities and on the boards of multiple non-profit organizations. He recently served on the Board of Trustees of Wake Forest University and Wake Forest University Baptist Medical Center. Mr. Marino received his B.A., J.D. and MBA from Rutgers University.
Our Board of Directors believes that Mr. Marino's perspective and experience advising the Company and numerous other leading life science companies in connection with financings, acquisitions and strategic alliances, provide him with the qualifications and skills to serve as a director.
Jerome E. Groopman, M.D. Dr. Groopman has served as a member of our Board of Directors since July 2013. Dr. Groopman has served as the Dina and Raphael Recanati Professor of Medicine at Harvard Medical School since January 1992. He has also served as Attending Hematologist/Oncologist at Beth Israel Deaconess Medical Center since July 1996. Dr. Groopman received an M.D. from Columbia University College of Physicians and Surgeons, and a B.A. in Political Philosophy from Columbia College.
Our Board of Directors believes Dr. Groopman's perspective and experience in the healthcare industry, as well as his educational background, provide him with the qualifications and skills to serve as a director.
Steven M. Fruchtman, M.D. Dr. Fruchtman was appointed as a member of our Board of Directors and as our Chief Executive Officer on January 15, 2019. He was appointed President in June 2018 and continues to serve as President. Dr. Fruchtman served as our Chief Medical Officer and Senior Vice President, Research and Development from January 2015 to November 2018. Dr. Fruchtman is a board certified hematologist with extensive industry experience in clinical research for myelodysplastic syndromes, hematologic malignancies and solid tumors.
From June 2014 to January 2015, Dr. Fruchtman was a hematology oncology drug development consultant. From September 2013 to June 2014, Dr. Fruchtman served as Chief Medical Officer at Syndax Pharmaceuticals, Inc., a biopharmaceutical company. From July 2011 to July 2013, Dr. Fruchtman was the Chief Medical Officer and Senior Vice President of Research and Regulatory Affairs at Spectrum Pharmaceuticals, a biopharmaceutical company focused(“Spectrum”). From February 2011 to June 2011, he was Vice President of Research at Spectrum. From February 2009 to January 2011, Dr. Fruchtman was Vice President, Clinical Research at Allos Therapeutics, Inc., a biopharmaceutical company. Prior to this, Dr. Fruchtman held senior positions at Novartis and Ortho Biotech Products. Dr. Fruchtman was on discoveringthe faculty of the Mount Sinai School of Medicine and was the Director of the Stem Cell Transplantation and Myeloproliferative Disorder Programs at Mount Sinai Hospital in New York City. Dr. Fruchtman received his medical degree from New York Medical College and his B.A. from Cornell University.
Our Board of Directors believes Dr. Fruchtman's perspective and experience as our Chief Medical Officer, President and Chief Executive Officer, as well as his depth of experience in the healthcare industry and his educational background, provide him with the qualifications and skills to serve as a director.
M. Teresa Shoemaker. Ms. Shoemaker has served as a member of our Board of Directors since April 2020. Ms. Shoemaker served as the President and CEO of Medexus Pharmaceuticals, Inc. (“Medexus”) from October 2018 to May 2020. Prior to joining Medexus, she served as President and CEO and board member of Medac Pharma, Inc. from its inception in June 2012 until its acquisition by Medexus in October 2018. Ms. Shoemaker implemented Medac's commercial strategy in support of a commercial product for the treatment of rheumatoid arthritis. Previously, Ms. Shoemaker served as Principal and Co-Founder of BioPharm Strategic Solutions from 2010 to 2012. From October 2009 to July 2010, she served as Vice President of Sales at InterMune, Inc. From 2002 to 2008, Ms. Shoemaker served as National Sales Director and then Sr. Director US Commercial Operations for Pharmion Corporation (“Pharmion”). In 2008, when Celgene Corporation acquired Pharmion, Ms. Shoemaker remained as Executive Director of Strategic Commercial Operations working as part of the executive transition team until 2009. Ms. Shoemaker began her career at DuPont Pharmaceuticals, which was acquired by Bristol Myers Squibb in 2000, where she held a number of sales and marketing leadership positions. Ms. Shoemaker holds B.S. degrees in Communication Science and Psychology from Missouri State University, and a M.S. degree in Communication Science and Disorders from University of Central Missouri.
Our Board of Directors believes that Ms. Shoemaker's experience holding senior leadership positions in the life sciences industry and her specific skills, developing novel productsand managing commercial organizations in the life sciences industry, provide her with the qualifications and skills to serve as a director.
Viren Mehta. Dr. Mehta has served as a member of our Board of Directors since February 2004. Dr. Mehta has been a managing member of Mehta Partners since 1997. Mehta Partners provides strategic advisory services to the biotechnology and pharmaceutical companies worldwide. Prior to founding Mehta Partners, Dr. Mehta co-founded Mehta and Isaly in 1989, and prior to that was a part of the strategic planning team of the International Division at Merck & Co. Dr. Mehta earned a Doctor of Pharmacy at the University of Southern California, and an M.B.A. from the Anderson School of Business at the University of California, Los Angeles. His board affiliations include BlinkBio, Yisheng Biopharma, Project Hope and the Venice Family Clinic.
Our Board of Directors believes Dr. Mehta's perspective and experience in the life sciences industry as a biopharma fund manager, fund consultant and a strategic advisor to senior managers in the biopharma industry, as well as his educational background, provide him with the qualifications and skills to serve as a director.
Executive Officers
The following table sets forth certain information regarding our executive officers who are not also directors.
Name | Age | Position(s) with Onconova Therapeutics, Inc. | ||||
Abraham N. Oler, J.D. | 45 | Senior Vice President, Corporate Development and General Counsel | ||||
Mark P. Guerin | 52 | Chief Financial Officer |
Abraham N. Oler, J.D. Mr. Oler has served as our Senior Vice President, Corporate Development and General Counsel since January 2020. Previously, he served as Vice President, Corporate Development and General Counsel since December 2018. Prior to joining us, from 2010 to 2018, Mr. Oler was Vice President of Operations at Spectrum, where he headed the legal function and worked in corporate development. Additionally, he served as Chief of Staff to the CEO and corporate secretary. He was also an officer and director for patients with cancer. We have proprietary targeted anti-cancer agents designedseveral Spectrum subsidiary companies. From 2007 to disrupt specific cellular pathways2010, Mr. Oler was a corporate attorney at the international law firm of Kirkland & Ellis LLP. Mr. Oler received his J.D. and an M.B.A. from Northwestern University. He received an M.Sc. in Politics of the World Economy from the London School of Economics and a B.S.in Economics and a B.A. in International Relations from the University of Pennsylvania.
Mark P. Guerin. Mr. Guerin has served as our Chief Financial Officer since September 1, 2016. Previously, he served as Vice President—Financial Planning & Accounting, and Chief Accounting Officer since May 2014, and as Vice President—Financial Planning & Accounting from September 2013 to May 2014. He has also served as our principal financial officer since February 12, 2016. Between January 2012 and September 2013, Mr. Guerin was self-employed as a financial and accounting consultant. For more than six years, through December 2011, Mr. Guerin was employed by CardioKine, Inc. and served as Chief Financial Officer from mid-2009 through December 2011. Mr. Guerin received his B.A. in Accounting from DeSales University.
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Corporate Governance
Board Composition
Our Board of Directors currently consists of six members. Our Board of Directors has undertaken a review of the independence of our directors and has determined that all directors, except Steven M. Fruchtman, M.D., are important for cancer cell proliferation.independent within the meaning of Section 5605(a)(2) of the NASDAQ Stock Market listing rules and Rule 10A-3 under the Securities Exchange Act of 1934, as amended (the "Exchange Act"). Our Tenth Amended and Restated Certificate of Incorporation, as amended, provides that our Board of Directors will consist of not less than three nor more than 11 directors, as such number of directors may from time to time be fixed by our Board of Directors. Each director shall be elected to the Board of Directors to hold office until the next annual meeting of stockholders and until his or her successor is elected and qualified.
Board Leadership Structure and Role in Risk Oversight
Our Board of Directors recognizes the time, effort and energy that the chief executive officer is required to devote to his position in the current business environment, as well as the commitment required to serve as our chairman, particularly as the Board of Directors' oversight responsibilities continue to grow. We believe that, the product candidates inat present, separating these positions allows our pipeline have the potential to be efficacious in a variety of cancers with unmet medical need. We have the following two clinical-stage programs: 1. ON 123300, 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. We are currently evaluating potential compounds for in-licensing opportunities.
While our bylaws do not planrequire that our chairman and chief executive officer positions be separate, our Board of Directors believes that having separate positions is the appropriate leadership structure for us at this time and demonstrates our commitment to further pursue intravenous rigosertib for treating HR-MDS.
Risk is inherent with every business, and how well a business manages risk can ultimately determine its success. We believe based on data from preclinical studies, that ON 123300 has the potential to overcome the limitationsface a number of the current generation of approved cyclin dependent kinase (CDK 4/6) inhibitors. Pursuant to a license agreement with Temple University dated January 1, 1999 as amended March 21, 2013, we licensed compounds including ON 123300 from Temple University. ON 123300 monolactate (ON 123300) is a novel multi kinase inhibitor that targets both CDK4/6 as well as other tyrosine kinases believed to drive tumor proliferation. The below table depicts the inhibitory concentration by 50% (IC
Kinase | | | ON 123300 IC50 (nM) | | | PALBOCICLIB IC50 (nM) | | |||
CDK 4/cyclin D1 | | | | | 3.87 | | | | 5.36 | |
CDK 6/cyclin D1 | | | | | 9.82 | | | | 3.76 | |
ARK 5 | | | | | 4.95 | | | | >5,000.00 | |
FLT3 | | | | | 12.22 | | | | >10,000.00 | |
FYN | | | | | 11.09 | | | | >10,000.00 | |
FMS | | | | | 10.00 | | | | >10,000.00 | |
PDGFRβ | | | | | 26.00 | | | | >10,000.00 | |
FGFR1 | | | | | 26.00 | | | | >10,000.00 | |
ABL | | | | | 53.32 | | | | >10,000.00 | |
PI3K-δ | | | | | 144.00 | | | | >10,000.00 | |
Our Board of Directors is actively involved in oversight of risks that could affect us. This oversight is resistant to approved second generation CDK 4/6 inhibitors as well as patients diagnosed with advanced Non-Hodgkin’s lymphoma. In partnership with HanX, a complementary Phase 1 studyconducted primarily through the audit committee of our Board of Directors, but the full Board of Directors has retained responsibility for patients with advanced relapsed/refractory cancergeneral oversight of risks.
Board Committees
Our Board of Directors has been initiated in China at two sitesestablished three standing committees: the audit committee, the compensation committee and the first patient was enrolled on September 15,nominating and corporate governance committee. The current members of our audit committee are James J. Marino, Viren Mehta and Jack E. Stover, with Jack E. Stover serving as chairperson. The current members of our compensation committee are M. Teresa Shoemaker, James J. Marino and Jack E. Stover with M. Teresa Shoemaker serving as chairperson. The current members of our nominating and corporate governance committee are M. Teresa Shoemaker, Viren Mehta and Jerome E. Groopman, M.D., with Viren Mehta serving as chairperson.
Our Board of Directors has determined that James J. Marino, Viren Mehta and Jack E. Stover meet the additional test for independence for audit committee members imposed by Securities and Exchange Commission ("SEC") regulations and Section 5605(c)(2)(A) of the NASDAQ Stock Market listing rules and that M. Teresa Shoemaker, James J. Marino and Jack E. Stover meet the additional test for independence for compensation committee members imposed by Section 5605(d)(2)(A) of the NASDAQ Stock Market listing rules.
Audit Committee
The primary purpose of our audit committee is to assist the Board of Directors in the oversight of the integrity of our accounting and financial reporting process, the audits of our consolidated financial statements, and our compliance with legal and regulatory requirements. Our audit committee met four times during fiscal year 2020. The initial dose cohort has been completedfunctions of our audit committee include, among other things:
• hiring the independent registered public accounting firm to conduct the annual audit of our consolidated financial statements and monitoring its independence and performance;
• reviewing and approving the second dose cohort is enrolling. No dose limiting toxicities (DLT) have been observed to date. Collectively, these two Phase 1 studies are expected to provide data regarding the safety profile of ON 123300 and potentially preliminary efficacy signals in patients with advanced cancer.
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• pre-approving all audit services and permissible non-audit services provided by our independent registered public accounting firm;
• reviewing the significant accounting and reporting principles to begin clinical trials of rigosertib in patients with COVID-19.
• reviewing our internal financial, operating and accounting controls with management, our independent registered public accounting firm and our internal audit provider;
• reviewing with management and our independent registered public accounting firm, as appropriate, our financial reports, earnings announcements and our compliance with legal and regulatory requirements;
• periodically reviewing and discussing with management the effectiveness and adequacy of our system of internal controls;
• in consultation with management and the independent auditors, reviewing the integrity of our financial reporting process and adequacy of disclosure controls;
• reviewing potential conflicts of interest under and violations of our code of conduct;
• establishing procedures for patients with myelodysplastic syndromes (“MDS”). Rigosertib has been tested in an intravenous formulationthe treatment of complaints received by us regarding accounting, internal accounting controls or auditing matters and confidential submissions by our employees of concerns regarding questionable accounting or auditing matters;
• reviewing and approving related-party transactions; and
• reviewing and evaluating, at least annually, our audit committee's charter.
With respect to reviewing and approving related-party transactions, our audit committee reviews related-party transactions for potential conflicts of interests or other improprieties. Under SEC rules, as a single agentsmaller reporting company, related-party transactions are those transactions to which we are or may be a party in which the amount involved exceeds the lesser of $120,000 or 1% of the average of our total assets at year-end for patientsthe last two completed fiscal years, and in which any of our directors or executive officers or any other related person had or will have a direct or indirect material interest, excluding, among other things, compensation arrangements with relapsed/refractory higher-risk MDS (“HR-MDS”),respect to employment and an oral formulation asBoard of Directors membership. Our audit committee could approve a single agentrelated-party transaction if it determines that the transaction is in lower risk MDSour best interests. Our directors are required to disclose to this committee or in combination with azacitidine for patients with newly diagnosedthe full Board of Directors any potential conflict of interest, or refractory HR-MDS.
The financial literacy requirements of the SEC require that each member of our audit committee be able to read and understand fundamental financial statements. In addition, at least one member of our audit committee must qualify as an audit committee financial expert, as defined in Item 407(d)(5) of Regulation S-K promulgated under the Securities Act, and have financial sophistication in accordance with the NASDAQ Stock Market listing rules. Our Board of Directors has determined that Jack E. Stover qualifies as an audit committee financial expert.
Both our independent registered public accounting firm and management periodically will meet privately with our audit committee.
The Board of Directors has adopted a charter for the audit committee, which is available in the corporate governance section of our website at http://www.onconova.com.
Compensation Committee
The primary endpoint of INSPIRE was improvement in overall survival. We completed enrollment of the required 360 randomized patients in March 2020, and in July 2020, the required number of survival events was reached.
• designing and development expenses of $16.9 millionimplementing competitive compensation, retention and $15.5 million duringseverance policies to attract and retain key personnel;
• reviewing and formulating policy and determining the years ended December 31, 2020 and 2019, respectively. We anticipate that a significant portioncompensation of our operating expenses will continueChief Executive Officer, our other executive officers and employees;
• reviewing and recommending to be relatedour Board of Directors the compensation of our non-employee directors;
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• reviewing and evaluating our compensation risk policies and procedures;
• administering our equity incentive plans and granting equity awards to researchour employees, consultants and development.
• administering our performance bonus plans and License Agreements
• if required from time to time, preparing the analysis or reports on development of novel oncology products, for the further development, registration and commercialization in Greater China of ON 123300. We believe ON 123300 has the potentialexecutive officer compensation required to overcome limitations of current generation CDK 4/6 inhibitors. Under the terms of the agreement, we 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 health authority IND approval. The Chinese IND was approved in January 2020. We and HanX also intended for these studies to comply with the FDA standards. Accordingly, such studies were used by us for an IND filing with the FDA in November 2020. The FDA Study May Proceed letter was received in December 2020 and first patient in the study is anticipated in the first half of 2021. Drug product for the US study was manufactured in North America and stability data was submitted as part of the IND. We maintain global rights to ON 123300 outside of China.
• engaging compensation consultants or other advisors it deems appropriate to assist with its duties; and
• reviewing and evaluating, at least annually, our compensation committee's charter.
The Board of Directors has adopted a commercial supply agreementcharter for the compensation committee, which is available in the corporate governance section of our website at http://www.onconova.com.
The compensation committee has utilized Radford ("Radford"), an Aon Hewitt company, as its executive compensation consultant. Radford reports directly to the compensation committee. The compensation committee may replace Radford or hire additional consultants at any time. Upon request by the compensation committee or its chair, a representative of Radford attends meetings of the compensation committee and is available to discuss compensation issues in between meetings.
In connection with its work for the compensation committee, Radford provided various executive compensation services to the compensation committee pursuant to a written consulting agreement. Generally, these services included advising the compensation committee on the principal aspects of our executive compensation program and evolving industry practices and providing market information and analysis regarding the competitiveness of our program design and our award values in relation to performance.
The compensation committee retains sole authority to hire any compensation consultant, approve such consultant's compensation, determine the nature and scope of its services, evaluate its performance, and terminate its engagement. We assessed the independence of Radford pursuant to SEC rules and determined that no known conflict of interest existed that would prevent Radford from serving as an independent consultant to the compensation committee.
The compensation committee has reviewed our compensation policies and practices for all employees, including our named executive officers, as they relate to risk management practices and risk-taking incentives, and has determined that there are no risks arising from these policies and practices that are reasonably likely to have a material adverse effect on us.
Nominating and Corporate Governance Committee
The primary purpose of our nominating and corporate governance committee is to assist our Board of Directors in promoting the best interest of our company and our stockholders through the implementation of sound corporate governance principles and practices. Our nominating and corporate governance committee met four times during fiscal 2020. The functions of our nominating and corporate governance committee include, among other things:
• identifying, reviewing and evaluating candidates to serve on our Board of Directors;
• determining the minimum qualifications for service on our Board of Directors;
• developing and recommending to our Board of Directors an annual self-evaluation process for our Board of Directors and overseeing the annual self-evaluation process;
• developing, as appropriate, a set of corporate governance principles, and reviewing and recommending to our Board of Directors any changes to such principles; and
• periodically reviewing and evaluating our nominating and corporate governance committee's charter.
The Board of Directors has adopted a charter for the nominating and corporate governance committee, which is available in the corporate governance section of our website at http://www.onconova.com.
Code of Conduct for Employees, Executive Officers and Directors
We have adopted a code of conduct applicable to all of our employees, executive officers and directors. The code of conduct is available in the corporate governance section of our website at http://www.onconova.com.
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The audit committee of our Board of Directors is responsible for overseeing the code of conduct and must approve any waivers of the code of conduct for employees, executive officers or directors.
Meetings of the Board of Directors
The Board of Directors held eleven meetings during fiscal 2020. During fiscal 2020, each director attended at least 75 percent of the aggregate of the total number of meetings of the Board of Directors and the committees on which such director served.
Directors are encouraged, but not required, to attend the annual meeting of stockholders. All of our directors attended the 2020 Annual Meeting of Stockholders.
Director Nomination Process
The process followed by our nominating and corporate governance committee to identify and evaluate director candidates includes requests to members of our Board of Directors and others for recommendations, meetings from time to time to evaluate biographical information and background material relating to potential candidates and interviews of selected candidates by members of the nominating and corporate governance committee and the Board of Directors.
In determining whether to recommend any particular candidate for inclusion in the Board of Directors' slate of recommended director nominees, our nominating and corporate governance committee considers the composition of the Board of Directors with respect to depth of experience, balance of professional interests, required expertise and other factors. The nominating and corporate governance committee considers the value of diversity when recommending candidates. The committee views diversity broadly to include diversity of experience, skills and viewpoint. The nominating and corporate governance committee does not assign specific weights to particular criteria and no particular criterion is a prerequisite for each prospective nominee. Our Board of Directors believe that the backgrounds and qualifications of its directors, considered as a group, should provide a composite mix of experience, knowledge and abilities that will allow it to fulfill its responsibilities.
Stockholders may recommend individuals to our nominating and corporate governance committee for consideration as potential director candidates. The nominating and corporate governance committee will evaluate stockholder-recommended candidates by following the same process and applying the same criteria as it follows for candidates submitted by others.
Stockholders may directly nominate a person for election to our Board of Directors by complying with the procedures set forth in Section 2.2(A) of our bylaws, and with the rules and regulations of the SEC. Under our bylaws, only persons nominated in accordance with the procedures set forth in the bylaws will be negotiatedeligible to serve as directors. In order to nominate a candidate for service as a director, you must be a stockholder at the time you give the Board of Directors notice of your nomination, and you must be entitled to vote for the election of directors at the meeting at which your nominee will be considered. In addition, the stockholder must have given timely notice in writing to our Secretary. To be timely, a stockholder's notice must be delivered to the Secretary at our principal executive offices not later than the 90th day, nor earlier than the 120th day, prior to the first commercial saleanniversary of rigosertib. The supplythe prior year's annual meeting of development-stage product and the supply of commercial product will be at our cost plus a defined profit margin. We have additionally granted SymBio a right of first negotiation to license or obtain the rights to develop and commercialize compounds having a chemical structure similar to rigosertibstockholders (provided, however, that in the licensed territory.
Stockholder Communications with the Board of Directors
You can contact our Board of Directors to provide comments, to report concerns, or to ask a question, at the following address.
President
Onconova Therapeutics, Inc.
375 Pheasant Run
Newtown, PA 18940
United States
You may submit your concern anonymously or confidentially by postal mail. You may also indicate whether you are a stockholder, customer, supplier, or other interested party.
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Communications are distributed to our Board of Directors, or to any individual directors, as appropriate, depending on the facts and circumstances outlined in the communication.
ITEM 11. EXECUTIVE COMPENSATION.
Overview of Executive Compensation
The license agreement with SymBio will remain in effect untilcompensation committee of our Board of Directors is responsible for overseeing the expirationcompensation of all of our executive officers. In this capacity, our compensation committee annually reviews and approves the royalty term. However, the SymBio
2020 Summary Compensation Table
The upfront payment is being recognized ratably through December 2037, the expected term of the agreement. We recognize revenues related to the supply agreement with SymBio when control of the product is transferred to Symbio. Revenues related to the supply agreement were $5,000 and $55,000following table sets forth information for the fiscal years ended December 31, 2020 and 2019 respectively.concerning compensation of our principal executive officer and the two most highly compensated executive officers during 2020. We refer to these four executive officers as our "named executive officers."
Name and Principal Position | Year | Salary ($) | Bonus ($)(1) | Share- Based Awards ($)(2) | Stock Awards ($)(3) | All Other Compensation ($)(4) | Total ($) | |||||||||||||||||||||
Steven M. Fruchtman, M.D.(5) | 2020 | $ | 562,224 | $ | 280,000 | $ | 61,507 | $ | 118,173 | $ | 23,214 | $ | 1,045,118 | |||||||||||||||
President and Chief Executive Officer | 2019 | 509,215 | 191,452 | 50,000 | -- | 21,846 | 772,513 | |||||||||||||||||||||
Manoj Maniar, Ph.D.(6) | 2020 | $ | 451,500 | $ | 109,402 | $ | 20,212 | $ | 38,822 | $ | 558,555 | $ | 1,178,491 | |||||||||||||||
Senior Vice President, Product Development | 2019 | 416,795 | 133,580 | 10,750 | -- | 14,933 | 576,058 | |||||||||||||||||||||
Richard C. Woodman, M.D.(7) | 2020 | $ | 393,750 | $ | 99,750 | $ | 19,121 | $ | 36,733 | $ | 2,171 | $ | 551,525 | |||||||||||||||
Chief Medical Officer and Senior Vice President, Research and Development | 2019 | 375,000 | 18,740 | 20,000 | -- | 11,572 | 425,312 | |||||||||||||||||||||
Mark Guerin | 2020 | $ | 374,816 | $ | 108,909 | $ | 26,219 | $ | 50,364 | $ | 28,467 | $ | 588,775 | |||||||||||||||
Chief Financial Officer | 2019 | 353,600 | 108,800 | 16,250 | -- | 26,458 | 505,108 |
(1) | Represents discretionary annual bonus amounts paid. |
(2) | The amounts shown for 2020 represent the aggregate grant date fair value related to the grant of stock appreciation rights to our named executive officers in fiscal 2020 calculated in accordance with FASB ASC Topic 718 (excluding the effect of any estimate of future forfeitures). The amounts shown for 2019 represent the aggregate grant date fair value related to the grant of non-qualified stock options to our named executive officers in fiscal 2019, calculated in accordance with FASB ASC Topic 718 (excluding the effect of any estimate of future forfeitures). Additional information concerning our financial reporting of stock appreciation rights and stock options is presented in Note 10 to our Consolidated Financial Statements set forth in our Annual Report on Form 10-K for the year ended December 31, 2020. See the “Outstanding Equity Awards at Fiscal Year-End – 2020” table below for additional details regarding the stock appreciation rights that were granted to our named executive officers in fiscal 2020. |
(3) | The amounts shown represent the aggregate grant date fair value related to the grant of performance stock units to our named executive officers in fiscal 2020, calculated in accordance with FASB ASC Topic 718 (excluding the effect of any estimate of future forfeitures). Additional information concerning our financial reporting of performance stock units is presented in Note 10 to our Consolidated Financial Statements set forth in our Annual Report on Form 10-K for the year ended December 31, 2020. See the “Outstanding Equity Awards at Fiscal Year-End – 2020” table below for additional details regarding the performance stock units that were granted to our named executive officers in fiscal 2020. |
(4) | Includes amounts paid for insurance premiums on behalf of the named executive officer and matching funds paid pursuant to our 401(k) Plan. |
(5) | Dr. Fruchtman was appointed as our Chief Executive Officer and a director on January 15, 2019. |
(6) | Dr. Maniar was terminated as our Senior Vice President, Product Development on December 15, 2020, which termination was treated as a termination without cause. In connection with Dr. Maniar’s termination from employment, in accordance with the terms of his employment agreement, dated dated July 1, 2015 and his stock appreciation rights agreement, he was due severance equal to nine months of his then current base salary, plus target bonus ($519,225), reimbursement for COBRA for nine months (approximately $9,798 in value), and acceleration of his outstanding stock options and stock appreciation rights (approximately $494 in value, based on spread as of his termination date). The total of these termination expenses of $529,517 is included in the All Other Compensation column for Dr. Maniar for 2020. |
(7) | Dr. Woodman resigned as our Senior Vice President, Research and Development and Chief Medical Officer on January 15, 2021. |
7 |
Employment Agreements
We have entered into a License, Developmentemployment agreements with each of our named executive officers, 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”). Underthe compensation of our named executive officers is determined, in large part, by the terms of the Pint License Agreement, we 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 (the “Pint Licensed Product”) containing rigosertib in all uses of rigosertib or the Product in humans in Latin America countries (the “Pint Territory,” including Argentina, Belize, Bolivia, Brazil, Chile, Colombia, Costa Rica, Cuba, Dominican Republic, Ecuador, El Salvador, French Guiana, British Guiana, Suriname, Guatemala, Haiti, Honduras, Mexico, Nicaragua, Panama, Paraguay, Peru, Uruguay and Venezuela).
Steven Fruchtman, M.D.
We entered into a Distribution, License and Supply Agreementan employment agreement with Dr. Fruchtman on June 19, 2018, which supersedes any prior employment agreements (the “Knight License“Employment Agreement”) with Knight Therapeutics Inc. (“Knight”). Under the terms of the License Agreement, we 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) (the “Knight Territory”) and in human uses (the “Knight Licensed 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 Knight Licensed Field.
The Employment Agreement provides for an initial base salary of either party. We may terminate the license agreement for any reason by giving Temple prior written notice.
Dr. Fruchtman is entitled to participate in all of our employee benefit plans and couldprograms that are made generally available from time to time to our executive officers and is entitled to vacation benefits. Dr. Fruchtman's Employment Agreement contains non-solicitation, non-competition, confidentiality and inventions assignment provisions that, among other things, prevent him from competing with us during the term of his employment and for a specified time thereafter. The Company will reimburse Dr. Fruchtman for reasonable expenses including certain commuting costs to the Company's offices.
If Dr. Fruchtman's employment is terminated due to his death, disability, by us for "cause" or by Dr. Fruchtman without "good reason" during the term of his employment agreement, we will pay to Dr. Fruchtman or his spouse or estate the balance of his accrued and unpaid salary, unreimbursed expenses, and unused accrued vacation time through the termination date.
If Dr. Fruchtman's employment is terminated by us without "cause" or by Dr. Fruchtman for "good reason," other than during a change in control protection period, Dr. Fruchtman will be entitled to receive severance equal to the sum of his current base salary and target bonus for the fiscal year during which his employment ceases. If the termination is during a change in control protection period, Dr. Fruchtman will be entitled to receive severance equal to the sum of his current base salary and target bonus for the fiscal year during which his employment ceases. A change in control protection period is the twelve months following a change in control. The Company will also affect the price that some investors are willing to pay for our common stock.
| | | Year ended December 31, | | |||||||||
| | | 2020 | | | 2019 | | ||||||
SymBio | | | | $ | 231,000 | | | | | $ | 282,000 | | |
HanX | | | | | — | | | | | | 1,751,000 | | |
Knight | | | | | — | | | | | | 100,000 | | |
STA | | | | | — | | | | | | 50,000 | | |
| | | | $ | 231,000 | | | | | $ | 2,183,000 | | |
| | | 2020 | | | 2019 | | ||||||
General and administrative | | | | $ | 8,326,000 | | | | | $ | 8,345,000 | | |
Research and development | | | | | 16,898,000 | | | | | | 15,537,000 | | |
Total operating expenses | | | | $ | 25,224,000 | | | | | $ | 23,882,000 | | |
| | | Year ended December 31, | | |||||||||
| | | 2020 | | | 2019 | | ||||||
Pre-clinical & clinical development | | | | $ | 7,948,000 | | | | | $ | 8,703,000 | | |
Personnel related | | | | | 4,444,000 | | | | | | 4,489,000 | | |
Manufacturing, formulation & development | | | | | 1,411,000 | | | | | | 526,000 | | |
Stock-based compensation | | | | | 209,000 | | | | | | 327,000 | | |
Consulting fees | | | | | 2,886,000 | | | | | | 1,492,000 | | |
| | | | $ | 16,898,000 | | | | | $ | 15,537,000 | | |
| | | Year ended December 31, | | |||||||||
| | | 2020 | | | 2019 | | ||||||
General and administrative | | | | $ | 160,000 | | | | | $ | 721,000 | | |
Research and development | | | | | 209,000 | | | | | | 327,000 | | |
| | | | $ | 369,000 | | | | | $ | 1,048,000 | | |
Description | | | Classification | | | Exercise Price | | | Expiration Date | | | Balance December 31, 2019 | | | Warrants Issued | | | Warrants Exercised | | | Balance December 31, 2020 | | |||||||||||||||
Non-tradable warrants | | | Liability | | | | $ | 172.50 | | | | July 2021 | | | | | 6,456 | | | | | | — | | | | | | — | | | | | | 6,456 | | |
Tradable warrants | | | Liability | | | | $ | 73.80 | | | | July 2021 | | | | | 212,801 | | | | | | — | | | | | | — | | | | | | 212,801 | | |
Non-tradable pre-funded warrants | | | Equity | | | | $ | 0.15 | | | | July 2023 | | | | | 394 | | | | | | — | | | | | | — | | | | | | 394 | | |
Non-tradable warrants | | | Equity | | | | $ | 1.60 | | | | December 2022 | | | | | 392,834 | | | | | | — | | | | | | — | | | | | | 392,834 | | |
Non-tradable warrants | | | Equity | | | | $ | 14.10 | | | | March 2021 | | | | | 5,000 | | | | | | — | | | | | | — | | | | | | 5,000 | | |
Non-tradable warrants | | | Equity | | | | $ | 21.15 | | | | March 2021 | | | | | 8,333 | | | | | | — | | | | | | — | | | | | | 8,333 | | |
Non-tradable warrants | | | Equity | | | | $ | 7.7895 | | | | June 2021 | | | | | 15,000 | | | | | | — | | | | | | — | | | | | | 15,000 | | |
Non-tradable pre-funded warrants | | | Equity | | | | $ | 0.15 | | | | none | | | | | 52,834 | | | | | | — | | | | | | — | | | | | | 52,834 | | |
Non-tradable warrants | | | Equity | | | | $ | 1.600 | | | | December 2022 | | | | | 1,806,104 | | | | | | — | | | | | | — | | | | | | 1,806,104 | | |
Non-tradable pre-funded warrants | | | Equity | | | | $ | 0.15 | | | | none | | | | | 74,617 | | | | | | — | | | | | | — | | | | | | 74,617 | | |
Non-tradable warrants | | | Equity | | | | $ | 2.00 | | | | September 2023 | | | | | 109,585 | | | | | | — | | | | | | — | | | | | | 109,585 | | |
Non-tradable pre-funded warrants | | | Equity | | | | $ | 0.0001 | | | | none | | | | | 1,250,000 | | | | | | — | | | | | | (1,250,000) | | | | | | — | | |
Non-tradable warrants | | | Equity | | | | $ | 0.20 | | | | November 2024 | | | | | 41,037,000 | | | | | | — | | | | | | (34,894,500) | | | | | | 6,142,500 | | |
Non-tradable warrants | | | Equity | | | | $ | 0.250 | | | | November 2024 | | | | | 2,521,875 | | | | | | — | | | | | | (2,521,875) | | | | | | — | | |
Non-tradable warrants | | | Equity | | | | $ | 0.287 | | | | December 2024 | | | | | 3,581,662 | | | | | | — | | | | | | (3,581,662) | | | | | | — | | |
Non-tradable warrants | | | Equity | | | | $ | 0.43625 | | | | December 2024 | | | | | 716,332 | | | | | | — | | | | | | (462,034) | | | | | | 254,298 | | |
Non-tradable warrants | | | Equity | | | | $ | 0.298 | | | | December 2024 | | | | | 3,469,716 | | | | | | — | | | | | | (3,469,716) | | | | | | — | | |
Non-tradable warrants | | | Equity | | | | $ | 0.45030 | | | | December 2024 | | | | | 693,943 | | | | | | — | | | | | | — | | | | | | 693,943 | | |
Non-tradable warrants | | | Equity | | | | $ | 0.45190 | | | | December 2023 | | | | | — | | | | | | 1,383,126 | | | | | | (933,610) | | | | | | 449,516 | | |
| | | | | | | | | | | | | | | | | 55,954,486 | | | | | | 1,383,126 | | | | | | (47,113,397) | | | | | | 10,224,215 | | |
| | | Warrant Liability | | |||
Balance at December 31, 2018 | | | | $ | 176,000 | | |
Change in fair value upon re-measurement | | | | | (63,000) | | |
Balance at December 31, 2019 | | | | | 113,000 | | |
Change in fair value upon re-measurement | | | | | 208,000 | | |
Balance at December 31, 2020 | | | | $ | 321,000 | | |
| | | Year ended December 31, | | | | | | | | |||||||||
| | | 2020 | | | 2019 | | | Change | | |||||||||
Revenue | | | | $ | 231,000 | | | | | $ | 2,183,000 | | | | | $ | (1,952,000) | | |
Operating expenses: | | | | | | | | | | | | | | | | | | | |
General and administrative. | | | | | 8,326,000 | | | | | | 8,345,000 | | | | | | 19,000 | | |
Research and development | | | | | 16,898,000 | | | | | | 15,537,000 | | | | | | (1,361,000) | | |
Total operating expenses | | | | | 25,224,000 | | | | | | 23,882,000 | | | | | | (1,342,000) | | |
Loss from operations | | | | | (24,993,000) | | | | | | (21,699,000) | | | | | | (3,294,000) | | |
Change in fair value of warrant liability | | | | | (208,000) | | | | | | 63,000 | | | | | | (271,000) | | |
Other income, net | | | | | 48,000 | | | | | | 143,000 | | | | | | (95,000) | | |
Net loss before income taxes. | | | | | (25,153,000) | | | | | | (21,493,000) | | | | | | (3,660,000) | | |
Income taxes. | | | | | 4,000 | | | | | | 10,000 | | | | | | 6,000 | | |
Net loss. | | | | $ | (25,157,000) | | | | | $ | (21,503,000) | | | | | $ | (3,654,000) | | |
| | | Year Ended December 31, | | |||||||||
| | | 2020 | | | 2019 | | ||||||
Net cash (used in) provided by: | | | | ||||||||||
Operating activities | | | | $ | (23,075,000) | | | | | $ | (20,831,000) | | |
Investing activities | | | | | (15,000) | | | | | | (55,000) | | |
Financing activities | | | | | 19,357,000 | | | | | | 26,648,000 | | |
Effect of foreign currency translation | | | | | 32,000 | | | | | | (6,000) | | |
Net (decrease) increase in cash and cash equivalents | | | | $ | (3,701,000) | | | | | $ | 5,756,000 | | |
The Amendment removed Section 4(d) of the OriginalEmployment Agreement, under which if Dr. Fruchtman would voluntarily resign from employment within three months following the Company’s appointment of a new Chief Executive Officer (other than Dr. Fruchtman) and upon not less than 30 days’ notice, Dr. Fruchtman would be entitled to receive seven months of his current base salary, and any outstanding unvested options to purchase shares of Company common stock would become fully vested as of the date of termination.
In addition, under the Amendment, if Dr. Fruchtman’s employment is terminated by the Company without “cause” or by Dr. Fruchtman for “good reason,” other than during the 12-month period following a change in control of the Company, Dr. Fruchtman will be entitled to receive twelve months of his current
The Amendment also includes a provision on whistleblower protection and trade secrets.
Mark Guerin
We entered into an employment agreement with Mr. Guerin on July 1, 2015, which supersedes any prior employment agreements. The employment agreement continues indefinitely, unless terminated in accordance with the terms of the agreement.
8 |
The foregoing descriptionemployment agreement provides for an initial base salary of $243,165, subject to adjustment upon annual review by our board of directors, and subject to the compensation committee’s sole discretion, an annual bonus, based on the performance of Mr. Guerin and the Company, of up to 25% of such base salary. The bonus may be paid in the form of cash, stock options, shares of Common Stock, or a combination thereof, at our compensation committee’s discretion.
Mr. Guerin is entitled to participate in all of our employee benefit plans and programs that are made generally available from time to time to our executive officers and is entitled to vacation benefits. Mr. Guerin’s employment agreement contains non-solicitation, non-competition, confidentiality and inventions assignment provisions that, among other things, prevent him from competing with us during the term of his employment and for a specified time thereafter.
If Mr. Guerin’s employment is terminated due to his death, disability, by us for “cause” or by Mr. Guerin without “good reason” during the term of his employment agreement, we will pay to Mr. Guerin or his spouse or estate the balance of his accrued and unpaid salary, unreimbursed expenses, and unused accrued vacation time through the termination date.
If Mr. Guerin’s employment is terminated by us without “cause” or by Mr. Guerin for “good reason,” other than during a change in control protection period, Mr. Guerin will be entitled to receive severance equal to nine-twelfths of the sum of his current base salary and target bonus for the fiscal year during which his employment ceases. If the termination is during a change in control protection period, Mr. Guerin will be entitled to receive severance equal to the sum of his current base salary and target bonus for the fiscal year during which his employment ceases. A change in control protection period is the twelve months following a change in control. The Company will also reimburse Mr. Guerin for a portion of his medical insurance costs and all of Mr. Guerin’s incentive stock options that are unvested as of the date of such termination would fully vest as of the date of termination.
Stock Option and Other Compensation Plans
We maintain the 2018 Plan for the purpose of attracting key employees, directors and consultants, inducing them to remain with us and encouraging them to increase their efforts to make our business more successful. The plan provides for awards of stock options, stock appreciation rights, restricted stock, restricted stock units, deferred shares and other equity-based awards.
The following table contains certain information regarding equity awards held by the named executive officers as of December 31, 2020:
9 |
Outstanding Equity Awards at 2020 Fiscal Year-End
Number of Securities Underlying Unexercised Options | Number of Securities Underlying Unexercised Options | Option Exercise Price | Option Expiration | |||||||||||
Name | (#) Exercisable | (#) Unexercisable | ($) | Date | ||||||||||
Steven Fruchtman | 800 | (1) | - | 655.50 | 1/12/2025 | |||||||||
233 | (1) | - | 372.00 | 4/20/2025 | ||||||||||
266 | (1) | - | 222.00 | 9/25/2025 | ||||||||||
827 | - | 97.50 | 1/26/2026 | |||||||||||
1,666 | (2) | - | 48.60 | 9/1/2026 | ||||||||||
506 | (2) | - | 39.75 | 12/15/2026 | ||||||||||
1,760 | (2) | - | 40.50 | 1/17/2027 | ||||||||||
2,827 | (3) | 81 | 22.50 | 1/3/2028 | ||||||||||
21,478 | (4) | 5,188 | 6.90 | 7/26/2028 | ||||||||||
66,600 | (4) | 133,400 | 0.31 | 12/20/2029 | ||||||||||
1,273,800 | (6) | - | 0.56 | 7/9/2030 | ||||||||||
Manoj Maniar | 25 | - | 919.50 | 12/5/2021 | ||||||||||
200 | - | 1,992.00 | 12/18/2022 | |||||||||||
33 | - | 2,250.00 | 7/25/2023 | |||||||||||
266 | - | 2,022.00 | 12/20/2023 | |||||||||||
400 | - | 597.00 | 12/18/2024 | |||||||||||
266 | (1) | - | 348.00 | 4/16/2025 | ||||||||||
266 | (1) | - | 222.00 | 9/25/2025 | ||||||||||
689 | - | 97.50 | 1/26/2026 | |||||||||||
1,133 | (2) | - | 48.60 | 9/1/2026 | ||||||||||
372 | (2) | - | 39.75 | 12/15/2026 | ||||||||||
1,294 | (2) | - | 40.50 | 1/17/2027 | ||||||||||
1,907 | (3) | - | 22.50 | 1/3/2028 | ||||||||||
20,000 | (4) | - | 6.90 | 7/26/2028 | ||||||||||
5,000 | (5) | - | 3.41 | 12/12/2028 | ||||||||||
43,000 | (4) | - | 0.31 | 12/20/2029 | ||||||||||
418,600 | (6) | - | 0.56 | 7/9/2030 | ||||||||||
Richard C. Woodman | 10,416 | (4) | 9,584 | 5.85 | 11/5/2028 | |||||||||
26,640 | (4) | 53,360 | 0.31 | 12/20/2029 | ||||||||||
396,000 | (6) | - | 0.56 | 7/9/2030 | ||||||||||
Mark Guerin | 200 | - | 4,321.50 | 10/4/2023 | ||||||||||
40 | - | 2,022.00 | 12/20/2023 | |||||||||||
163 | - | 945.00 | 3/31/2024 | |||||||||||
166 | - | 597.00 | 12/18/2024 | |||||||||||
100 | (1) | - | 348.00 | 4/16/2025 | ||||||||||
116 | (1) | - | 222.00 | 9/25/2025 | ||||||||||
312 | - | 97.50 | 1/26/2026 | |||||||||||
999 | (2) | - | 48.60 | 9/1/2026 | ||||||||||
372 | (2) | - | 39.75 | 12/15/2026 | ||||||||||
1,294 | (2) | - | 40.50 | 1/17/2027 | ||||||||||
2,010 | (3) | 58 | 22.50 | 1/3/2028 | ||||||||||
20,670 | (4) | 4,993 | 6.90 | 7/26/2028 | ||||||||||
21,645 | (4) | 43,355 | 0.31 | 12/20/2029 | ||||||||||
543,000 | (6) | - | 0.56 | 7/9/2030 |
10 |
(1) 25% of the total shares underlying this option vested on July 25, 2014. The remaining shares vest 1/36th monthly over 36 months thereafter, subject to continued service to us through each vesting date.
(2) Shares vest in equal monthly installments over four years, 1/48th per month. The first shares vest one month after the date of grant.
(3) Shares vest in equal monthly installments over three years, 1/36th per month. The first shares vest one month after the date of grant.
(4) Shares vest over three years, one-third on the first anniversary of the date of grant and thereafter in 24 equal monthly installments over the following two years.
(5) Shares vest 100% on the first anniversary of the date of grant.
(6) These are cash-settled stock appreciation rights that vest over three years, one-third on the first anniversary of the date of grant and thereafter in 24 equal monthly installments over the following two years. Each of the executives also received cash-settled performance stock units on July 9, 2020, with vesting contingent upon the successful result of our Phase 3 clinical trial. The trial concluded in August 2020 and did not achieve its primary endpoints. The performance stock units will not vest and none were outstanding at December 31, 2020.
Potential Payments Upon Termination of Employment or Change in Control
As discussed under the caption "—Employment Agreements" above, we have agreements with our named executive officers pursuant to which they will receive severance payments upon certain termination events. The information below describes certain compensation that would be available under our existing plans and arrangements if (i) the named executive officer was terminated as of December 31, 2020 or (ii) if a Change in Control, as defined in the applicable employment agreement or plan, occurred on December 31, 2020 and the named executive officer's employment had been subsequently terminated on the same date.
Acceleration of Equity Awards in connection with a Change in Control
Pursuant to the terms of each named executive officer's option agreements reflecting options granted under the 2013 Plan, in the event of a "Change in Control" that occurs during any time prior to such named executive officer's Termination of Service (as such terms are defined in our 2013 Plan) with us, all stock options granted pursuant to such option agreement shall fully vest and become exercisable. Pursuant to the terms of each named executive officer's option agreements reflecting options granted under the 2018 Plan, in the event of a "Change in Control" in which the Company is not the surviving corporation (or survives only as a subsidiary of another corporation) and the options are assumed by, or replaced with awards with comparable terms by, the surviving corporation (or parent or subsidiary of the surviving corporation) and the named executive officer's employment or service is terminated without "Cause" or the named executive officer terminates his employment for "Good Reason" (as such terms are defined in the applicable option grant agreement), all such stock options granted pursuant to such option agreement shall fully vest and become exercisable upon termination of employment or service. In the event that the surviving corporation (or a parent or subsidiary of the surviving corporation) does not assume or replace the options with grants that have comparable terms, and conditionsnamed executive officer is employed by, or providing services to, the Company and its subsidiaries on the date of the Amendment doesChange in Control, all stock options granted pursuant to such option agreement shall fully vest and become exercisable.
Termination Other than for Cause, Death or Disability; Resignation for Good Reason
The payments and benefits to which each named executive officer would be entitled in the event the named executive officer's employment is terminated for any reason other than for cause, death, or disability, or if the named executive officer resigns for good reason, whether or not purportfollowing a "change in control" is described under the caption "—Employment Agreements" above.
11 |
Director Compensation
The following table summarizes compensation paid to be completeour non-employee directors in fiscal 2020.
Name | Fees Earned or Paid in Cash ($) | Stock Option Awards ($) (1) | All Other Compensation ($) | Total ($) | ||||||||||||
Jerome E. Groopman, M.D. | 61,500 | 6,460 | — | 67,960 | ||||||||||||
Michael B. Hoffman(2) | 52,667 | 6,460 | — | 59,127 | ||||||||||||
James J. Marino | 84,167 | 6,460 | — | 90,627 | ||||||||||||
Viren Mehta | 77,000 | 6,460 | — | 83,460 | ||||||||||||
E. Premkumar Reddy, Ph.D.(3) | 44,167 | 6,460 | 66,000 | (4) | 116,627 | |||||||||||
M. Teresa Shoemaker | 46,083 | 6,460 | — | 52,543 | ||||||||||||
Jack E. Stover | 85,000 | 6,460 | — | 91,460 |
(1) | The amounts shown represent the aggregate grant date fair value related to the grant of 125,000 cash-settled stock appreciation rights to each of our non-employee directors on July 9, 2020, calculated in accordance with FASB ASC Topic 718. These stock appreciation rights vest on the first anniversary of the grant and expire ten years after the grant date and are subject to the director’s continued service. Additional information concerning our financial reporting of stock appreciation rights is presented in Note 10 to our Consolidated Financial Statements set forth in our Annual Report on Form 10-K for the year ended December 31, 2020. |
(2) | Mr. Hoffman resigned from our Board of Directors on August 27, 2020. | |
(3) | Dr. Reddy resigned from our Board of Directors on August 27, 2020. |
(4) | Represents consulting fees paid to Dr. Reddy. See "Certain Relationships and Related Person Transactions." |
(5) | At December 31, 2020, the aggregate number of outstanding stock option awards held by each non-employee director was: Dr. Groopman—12,350; Mr. Marino—12,032; Dr. Mehta—12,030; Ms. Shoemaker—0; and Mr. Stover—11,965. At December 31, 2020, the aggregate number of stock appreciation rights held by each non-employee director was: Dr. Groopman—125,000; Mr. Marino—125,000; Dr. Mehta—125,000; Ms. Shoemaker—125,000; and Mr. Stover—125,000. |
In June 2013, our Board of Directors approved a non-employee director compensation policy, which became effective for all non-employee directors in July 2013. In June 2018, the Board of Directors revised the policy to change the retainer amounts and is qualifiedthe number of options members of our Board of Directors would receive, based on a benchmarking study comparing our director compensation to a group of comparable peer companies. In accordance with this policy, each non-employee director receives an annual base retainer of $40,000. In addition, our non-employee directors receive the following cash compensation for board services, as applicable:
• the chairman of our Board of Directors receives an additional annual retainer of $40,000;
• each member of our audit, compensation and nominating and corporate governance committees receives an additional retainer of $7,500, $5,000 and $4,000, respectively; and
• each chairperson of our audit, compensation and nominating and corporate governance committees receives an additional annual retainer of $15,000, $10,000 and $8,000, respectively, in its entirety byaddition to the full textretainer received for service as a member of such committee.
All amounts are paid in quarterly installments.
In addition, in accordance with the existing policy, newly appointed non-employee directors receive a one-time initial award of options to purchase 11,666 shares of our common stock, which vests annually over a three-year period subject to the director's continued service on the Board of Directors. Thereafter, each non-employee director receives an annual award of options to purchase 5,833 shares of our common stock, which vests on the first anniversary of the Amendment, which is attached heretogrant, subject to the director's continued service on the Board of Directors.
All of our directors are eligible to receive additional discretionary awards under our 2018 Omnibus Incentive Compensation Plan, as Exhibit 10.15.2 and is incorporated herein by reference.
We reimburse each non-employee director for the 2021 Annual Meetingout-of-pocket expenses incurred in connection with attending our Board of Stockholders (the “Proxy Statement”) under the headings “ElectionDirectors and committee meetings. Compensation for our directors, including cash and equity compensation, is determined, and remains subject to adjustment, by our Board of Directors,” “Executive Officers,” “Section 16(a) Beneficial Ownership Reporting Compliance,” “Code of Ethics” and “Corporate Governance” and is incorporated herein by reference.Directors.
12 |
Equity Compensation Plan Information
The following table summarizes the total number of outstanding options and shares available for other future issuances of options under all of our equity compensation plans as of December 31, 2020. All of the outstanding awards listed below were granted under our 2013 Equity Compensation Plan and 2018 Plan. See "Stock Option and Other Compensation Plans" above for a summary of the 2018 Plan.
Plan Category | Number of Shares to be Issued Upon Exercise of Outstanding Options, Warrants and Rights | Weighted-Average Exercise Price of Outstanding Options, Warrants and Rights | Number of Shares Remaining Available for Future Issuance Under the Equity Compensation Plan (Excluding Shares in First Column) | |||||||||
Equity compensation plans approved by stockholders | 869,095 | $ | 24.58 | 185,089 | ||||||||
Equity compensation plans not approved by stockholders | — | — | — |
PRINCIPAL STOCKHOLDERS
The following table sets forth certain information regarding the beneficial ownership of common stock as of March 31, 2021 by (a) each person known by us to be the beneficial owner of more than 5% of the outstanding shares of our common stock, (b) each of our named executive officers identified on page 7 of this Amendment under the heading, “2020 Summary Compensation Table,”, (c) each of our directors, and (d) all of our executive officers and directors as a group.
The percentage of common stock outstanding is based on 236,612,391 shares of common stock outstanding on March 31, 2021. For purposes of the table below, and in accordance with the rules of the SEC, we deem shares of common stock subject to warrants and options that are currently exercisable or exercisable within sixty days of March 31, 2021 to be outstanding and to be beneficially owned by the person holding the warrants and options for the purpose of computing the percentage ownership of that person, but we do not treat them as outstanding for the purpose of computing the percentage ownership of any other person. Except as otherwise noted, each of the persons or entities in this table has sole voting and investing power with respect to this item will be set forth inall of the Proxy Statement undershares of common stock beneficially owned by him, her or it, subject to community property laws, where applicable. Except as otherwise noted below, the headings “Security Ownershipstreet address of Certain Beneficial Ownerseach beneficial owner is c/o Onconova Therapeutics, Inc., 375 Pheasant Run, Newtown, PA 18940.
Name and Address of Beneficial Owner | Number of Shares Beneficially Owned | Percentage of Shares Beneficially Owned | ||||||
5% or greater stockholders: | ||||||||
Lincoln Park Capital Fund, LLC, Lincoln Park Capital, LLC, Rockledge Capital Corporation, Joshua B. Scheinfeld, Alex Noah Investors, Inc., Jonathan I. Cope 440 North Wells, Suite 410 Chicago, Illinois 60654(1) | 13,639,411 | 5.8 | % | |||||
Directors, Director Nominees and Named Executive Officers: | ||||||||
Jerome E. Groopman, M.D.(2) | 22,336 | * | ||||||
Manoj Maniar, Ph.D.(3) | 4 | * | ||||||
James J. Marino(4) | 392,748 | |||||||
Steven M. Fruchtman, M.D.(5) | 513,767 | * | ||||||
Viren Mehta(6) | 512,985 | * | ||||||
Jack E. Stover(7) | 15,106 | * | ||||||
M. Teresa Shoemaker | 50,735 | * | ||||||
Richard C. Woodman, M.D.(8) | 37,473 | * | ||||||
Mark Guerin(9) | 293,456 | * | ||||||
All current executive officers, directors and director nominees as a group (7 persons) (10) | 2,068,533 | 0.9 | % |
*Represents a beneficial ownership of less than one percent of our outstanding common stock.
(1) Based solely on a Schedule 13G filed with the SEC on January 8, 2021. The Schedule 13G was filed by Lincoln Park Capital Fund, LLC, Lincoln Park Capital, LLC, Rockledge Capital Corporation, Joshua B. Scheinfeld, Alex Noah Investors, Inc. and Management”Jonathan I. Cope. According to the Schedule 13G, as of January 7, 2021, Lincoln Park Capital Fund, LLC, Lincoln Park Capital, LLC, Rockledge Capital Corporation, Joshua B. Scheinfeld, Alex Noah Investors, Inc. and “Executive Compensation,”Jonathan I. Cope have shared voting power and is incorporated hereinshared dispositive power with regard to 13,639,411 of common stock, representing approximately 6.52% of the common stock.
13 |
(2) Includes 12,335 shares of common stock issuable upon the exercise of options that are currently exercisable or exercisable within sixty days of the record date.
(3) Manoj Maniar, Ph.D. was terminated as Senior Vice President, Product Development of the Company on December 15, 2020.
(4) Includes 162,032 shares of common stock issuable upon the exercise of warrants and options that are currently exercisable or exercisable within sixty days of the record date.
(5) Includes 258,643 shares of common stock issuable upon the exercise of warrants and options that are currently exercisable or exercisable within sixty days of the record date.
(6) Includes (i) 54 shares of common stock held by reference.Mehta Partners, LLC, (ii) 56 shares of common stock held by Viram Foundation and (iii) 262,030 shares of common stock issuable upon the exercise of warrants and options that are currently exercisable or exercisable within sixty days of the record date. Dr. Mehta, as managing member, has voting and dispositive power with regard to the shares held by Mehta Partners, LLC. Dr. Mehta, as trustee has voting and dispositive power with regard to the shares held by Viram Foundation.
(7) Includes 11,965 shares of common stock issuable upon the exercise of options that are currently exercisable or exercisable within sixty days of the record date.
(8) Includes 37,473 shares of common stock issuable upon the exercise of options that are currently exercisable or exercisable within sixty days of the record date. Richard C. Woodman, M.D. resigned as Senior Vice President, Research and Development and Chief Medical Officer of the Company on January 15, 2021.
(9) Includes 148,243 shares of common stock issuable upon the exercise of warrants and options that are currently exercisable or exercisable within sixty days of the record date.
(10) Includes 989,546 shares of common stock issuable upon the exercise of warrants and options that are currently exercisable or exercisable within sixty days of the record date.
14 |
Review and Approval of Related Person Transactions
The audit committee of our Board of Directors is charged with respectthe responsibility of reviewing and approving all related person transactions (as defined in SEC regulations), and periodically reassessing any related person transaction that we enter to this item will beensure continued appropriateness. This responsibility is set forth in our audit committee charter. A related party transaction will only be approved if the Proxy Statement underaudit committee determines that the headings “Certain Relationshipstransaction is in the best interests of the Company. If a director is involved in the transaction, he or she will recuse himself or herself from all decisions regarding the transaction.
The following is a description of transactions during fiscal 2020, to which we have been a party, in which the amount involved in the transaction exceeds the lesser of $120,000 or 1% of total assets, and Related Party Transactions”in which any of our current directors, executive officers or to our knowledge, beneficial owners of more than 5% of our capital stock or an affiliate or immediate family member thereof, had or will have a direct or indirect material interest, other than the employment relationships with our executive officers and “Corporate Governance”the related compensation solely resulting from those employment relationships.
On May 3, 2010, as subsequently amended, we entered into a research agreement with the Mount Sinai School of Medicine ("Mount Sinai"), with which E. Premkumar Reddy, Ph.D., a former member of our Board of Directors, is associated. The agreement expired in June 2020 and is incorporated hereinwas not renewed. The board member left the Company’s board in August 2020. The research was undertaken by reference.
See “Item 10. Directors, Executive Officers and Corporate Governance; Corporate Governance, Board Composition” above for a discussion regarding the independence of the members of our Board of Directors.
Fees of Independent Registered Public Accounting Firm”
The following table summarizes the fees of Ernst & Young LLP, our independent registered public accounting firm, billed to us for each of the last two fiscal years.
Fee Category | Fiscal 2020 | Fiscal 2019 | ||||||
Audit Fees(1) | $ | 297,500 | $ | 359,000 | ||||
Audit-Related Fees(2) | — | — | ||||||
Tax Fees(3) | — | — | ||||||
Total Fees | $ | 297,500 | $ | 359,000 |
(1) | Audit fees consist of fees for the audits of fiscal 2020 and 2019 and quarterly reviews of our consolidated financial statements and other professional services provided in connection with statutory and regulatory filings or engagements. |
(2) | Audit-related fees consist of fees for assurance and related services that are reasonably related to the performance of the audit and the review of our consolidated financial statements and which are not reported under "Audit Fees." |
(3) | Tax fees for fiscal 2020 and fiscal 2019 include fees for tax advice, tax return preparation assistance and review. |
Pre-Approval Policies and Procedures
Our audit committee's policy is incorporated hereinthat all audit services and all non-audit services to be provided to us by reference.
All audit services and all non-audit services in fiscal 2020 were pre-approved by our audit committee. Our audit committee has determined that the provision of the non-audit services for which these fees were rendered is compatible with maintaining the independent auditor's independence.
15 |
PART IV
Financial Statements on page F-1.
Included in Part II, Item 8 of the Original Report.
Exhibits
See Exhibit Index.
16 |
(3)
17 |
19 |
20 |
+ | Indicates management contract or compensatory plan. |
* | Confidential treatment has been requested with respect to certain portions of this exhibit. Omitted portions have been filed separately with the Securities and Exchange Commission. |
** | Portions of the exhibit have been omitted. |
# | Previously filed. |
21 |
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Date: April 30, 2021 | ||
Onconova Therapeutics, Inc. | ||
By: | /s/ STEVEN M. FRUCHTMAN, M.D. | |
Steven M. Fruchtman | ||
Chief Executive Officer |
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated:
Signature | Title | Date | ||||||
/s/ | Director, President and Chief Executive Officer | April 30, 2021 | ||||||
Steven M. Fruchtman, M.D. | (Principal Executive Officer) | |||||||
/s/ | Chief Financial Officer (Principal Financial | April 30, 2021 | ||||||
Mark Guerin | Officer and Principal Accounting Officer) | |||||||
/s/ | Chairman, Board of Directors | |||||||
/s/ | Director | April 30, 2021 | ||||||
Jerome E. Groopman, M.D. | ||||||||
/s/ VIREN MEHTA, PH.D. | Director | |||||||
J Viren Mehta, Ph.D. | ||||||||
/s/ MARY TERESA SHOEMAKER | Director | |||||||
Mary Teresa Shoemaker | ||||||||
/s/ JACK E. STOVER | Director | |||||||
Jack E. Stover |
| | | December 31, | | |||||||||
| | | 2020 | | | 2019 | | ||||||
Assets | | | | | | | | | | | | | |
Current assets: | | | | | | | | | | | | | |
Cash and cash equivalents | | | | $ | 19,025,000 | | | | | $ | 22,726,000 | | |
Receivables | | | | | 37,000 | | | | | | 98,000 | | |
Prepaid expenses and other current assets | | | | | 722,000 | | | | | | 650,000 | | |
Total current assets. | | | | | 19,784,000 | | | | | | 23,474,000 | | |
Property and equipment, net | | | | | 52,000 | | | | | | 50,000 | | |
Other non-current assets | | | | | 150,000 | | | | | | 150,000 | | |
Total assets. | | | | $ | 19,986,000 | | | | | $ | 23,674,000 | | |
Liabilities and stockholders’ equity | | | | | | | | | | | | | |
Current liabilities: | | | | | | | | | | | | | |
Accounts payable | | | | $ | 4,833,000 | | | | | $ | 4,271,000 | | |
Accrued expenses and other current liabilities | | | | | 4,962,000 | | | | | | 3,795,000 | | |
Deferred revenue | | | | | 226,000 | | | | | | 226,000 | | |
Total current liabilities. | | | | | 10,021,000 | | | | | | 8,292,000 | | |
Warrant liability. | | | | | 321,000 | | | | | | 113,000 | | |
Deferred revenue, non-current. | | | | | 3,469,000 | | | | | | 3,695,000 | | |
Total liabilities | | | | | 13,811,000 | | | | | | 12,100,000 | | |
Commitments and contingencies | | | | | | | | | | | | | |
Stockholders’ equity: | | | | | | | | | | | | | |
Preferred stock, $0.01 par value, 5,000,000 authorized at December 31, 2020 and 2019, none issued and outstanding at December 31, 2020 and 2019 | | | | | — | | | | | | — | | |
Common stock, $0.01 par value, 250,000,000 authorized at December 31, 2020 and 2019, 185,943,267 and 111,167,352 shares issued and outstanding at December 31, 2020 and 2019 . | | | | | 1,859,000 | | | | | | 1,112,000 | | |
Additional paid in capital | | | | | 432,858,000 | | | | | | 413,879,000 | | |
Accumulated other comprehensive income (loss). | | | | | 14,000 | | | | | | (18,000) | | |
Accumulated deficit. | | | | | (428,556,000) | | | | | | (403,399,000) | | |
Total stockholders’ equity | | | | | 6,175,000 | | | | | | 11,574,000 | | |
Total liabilities and stockholders’ equity. | | | | $ | 19,986,000 | | | | | $ | 23,674,000 | | |
| | | Years ended December 31, | | |||||||||
| | | 2020 | | | 2019 | | ||||||
Revenue | | | | $ | 231,000 | | | | | $ | 2,183,000 | | |
Operating expenses: | | | | | | | | | | | | | |
General and administrative | | | | | 8,326,000 | | | | | | 8,345,000 | | |
Research and development | | | | | 16,898,000 | | | | | | 15,537,000 | | |
Total operating expenses. | | | | | 25,224,000 | | | | | | 23,882,000 | | |
Loss from operations | | | | | (24,993,000) | | | | | | (21,699,000) | | |
Change in fair value of warrant liability. | | | | | (208,000) | | | | | | 63,000 | | |
Other income, net | | | | | 48,000 | | | | | | 143,000 | | |
Net loss before income taxes | | | | | (25,153,000) | | | | | | (21,493,000) | | |
Income tax expense. | | | | | 4,000 | | | | | | 10,000 | | |
Net loss | | | | | (25,157,000) | | | | | | (21,503,000) | | |
Net loss per share of common stock, basic and diluted | | | | $ | (0.14) | | | | | $ | (1.49) | | |
Basic and diluted weighted average shares outstanding | | | | | 174,035,872 | | | | | | 14,384,476 | | |
| | | Years ended December 31, | | |||||||||
| | | 2020 | | | 2019 | | ||||||
Net loss | | | | $ | (25,157,000) | | | | | $ | (21,503,000) | | |
Other comprehensive income (loss), before tax: | | | | | | | | | | | | | |
Foreign currency translation adjustments, net | | | | | 32,000 | | | | | | (6,000) | | |
Other comprehensive income (loss), net of tax | | | | | 32,000 | | | | | | (6,000) | | |
Comprehensive loss. | | | | $ | (25,125,000) | | | | | $ | (21,509,000) | | |
| | | Stockholders’ Equity | | |||||||||||||||||||||||||||||||||
| | | Common Stock | | | Additional Paid in Capital | | | Accumulated deficit | | | Accumulated other comprehensive income (loss) | | | Total | | |||||||||||||||||||||
| | | Shares | | | Amount | | ||||||||||||||||||||||||||||||
Balance at December 31, 2018.. | | | | | 5,674,220 | | | | | $ | 57,000 | | | | | $ | 387,238,000 | | | | | $ | (381,896,000) | | | | | $ | (12,000) | | | | | $ | 5,387,000 | | |
Net loss | | | | | — | | | | | | — | | | | | | — | | | | | | (21,503,000) | | | | | | — | | | | | | (21,503,000) | | |
Other comprehensive loss | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (6,000) | | | | | | (6,000) | | |
Stock-based compensation | | | | | — | | | | | | — | | | | | | 1,048,000 | | | | | | — | | | | | | — | | | | | | 1,048,000 | | |
Dissolution of GBO | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Issuance of common stock, pre-funded warrants and warrants, net | | | | | 60,757,970 | | | | | | 608,000 | | | | | | 21,151,000 | | | | | | — | | | | | | — | | | | | | 21,759,000 | | |
Issuance of common stock upon exercise of pre-funded warrants. | | | | | 23,720,784 | | | | | | 237,000 | | | | | | (202,000) | | | | | | — | | | | | | — | | | | | | 35,000 | | |
Issuance of common stock upon exercise of common warrants. | | | | | 21,014,378 | | | | | | 210,000 | | | | | | 4,644,000 | | | | | | — | | | | | | — | | | | | | 4,854,000 | | |
Balance at December 31, 2019.. | | | | | 111,167,352 | | | | | $ | 1,112,000 | | | | | $ | 413,879,000 | | | | | $ | (403,399,000) | | | | | $ | (18,000) | | | | | $ | 11,574,000 | | |
Net loss | | | | | — | | | | | | — | | | | | | — | | | | | | (25,157,000) | | | | | | — | | | | | | (25,157,000) | | |
Other comprehensive income | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 32,000 | | | | | | 32,000 | | |
Stock-based compensation | | | | | — | | | | | | — | | | | | | 369,000 | | | | | | — | | | | | | — | | | | | | 369,000 | | |
Issuance of common stock, net | | | | | 27,662,518 | | | | | | 276,000 | | | | | | 8,786,000 | | | | | | — | | | | | | — | | | | | | 9,062,000 | | |
Issuance of common stock upon exercise of common warrants. | | | | | 45,863,397 | | | | | | 458,000 | | | | | | 9,836,000 | | | | | | — | | | | | | — | | | | | | 10,294,000 | | |
Issuance of common stock upon exercise of pre-funded warrants. | | | | | 1,250,000 | | | | | | 13,000 | | | | | | (12,000) | | | | | | — | | | | | | — | | | | | | 1,000 | | |
Balance at December 31, 2020.. | | | | | 185,943,267 | | | | | $ | 1,859,000 | | | | | $ | 432,858,000 | | | | | $ | (428,556,000) | | | | | $ | 14,000 | | | | | $ | 6,175,000 | | |
| | | Year Ended December 31, | | |||||||||
| | | 2020 | | | 2019 | | ||||||
Operating activities: | | | | | | | | | | | | | |
Net loss | | | | $ | (25,157,000) | | | | | $ | (21,503,000) | | |
Adjustment to reconcile net loss to net cash used in operating activities: | | | | | | | | | | | | | |
Depreciation and amortization | | | | | 13,000 | | | | | | 14,000 | | |
Change in fair value of warrant liabilities | | | | | 208,000 | | | | | | (63,000) | | |
Stock compensation expense | | | | | 369,000 | | | | | | 1,048,000 | | |
Changes in assets and liabilities: | | | | | | | | | | | | | |
Receivables | | | | | 61,000 | | | | | | (63,000) | | |
Prepaid expenses and other assets | | | | | (72,000) | | | | | | 109,000 | | |
Accounts payable | | | | | 562,000 | | | | | | 232,000 | | |
Accrued expenses and other current liabilities | | | | | 1,167,000 | | | | | | (378,000) | | |
Deferred revenue | | | | | (226,000) | | | | | | (227,000) | | |
Net cash used in operating activities | | | | | (23,075,000) | | | | | | (20,831,000) | | |
Investing activities: | | | | | | | | | | | | | |
Payments for purchase of property and equipment | | | | | (15,000) | | | | | | (55,000) | | |
Net cash used in investing activities | | | | | (15,000) | | | | | | (55,000) | | |
Financing activities: | | | | | | | | | | | | | |
Proceeds from the sale of common stock, pre-funded warrants and warrants, net of costs | | | | | 9,062,000 | | | | | | 21,759,000 | | |
Proceeds from the exercise of common warrants | | | | | 10,294,000 | | | | | | 4,854,000 | | |
Proceeds from the exercise of pre-funded warrants | | | | | 1,000 | | | | | | 35,000 | | |
Net cash provided by financing activities | | | | | 19,357,000 | | | | | | 26,648,000 | | |
Effect of foreign currency translation on cash | | | | | 32,000 | | | | | | (6,000) | | |
Net (decrease) increase in cash and cash equivalents | | | | | (3,701,000) | | | | | | 5,756,000 | | |
Cash and cash equivalents at beginning of period | | | | | 22,726,000 | | | | | | 16,970,000 | | |
Cash and cash equivalents at end of period | | | | $ | 19,025,000 | | | | | $ | 22,726,000 | | |
| | | December 31, | | |||||||||
| | | 2020 | | | 2019 | | ||||||
Laboratory equipment | | | | $ | — | | | | | $ | 1,037,000 | | |
Software | | | | | — | | | | | | 92,000 | | |
Computer and office equipment | | | | | 70,000 | | | | | | 409,000 | | |
Leasehold improvements | | | | | — | | | | | | 745,000 | | |
| | | | | 70,000 | | | | | | 2,283,000 | | |
Less accumulated depreciation | | | | | (18,000) | | | | | | (2,233,000) | | |
| | | | $ | 52,000 | | | | | $ | 50,000 | | |
Description | | | Classification | | | Exercise Price | | | Expiration Date | | | Balance December 31, 2019 | | | Warrants Issued | | | Warrants Exercised | | | Balance December 31, 2020 | | |||||||||||||||
Non-tradable warrants | | | Liability | | | | $ | 172.50 | | | | July 2021 | | | | | 6,456 | | | | | | — | | | | | | — | | | | | | 6,456 | | |
Tradable warrants | | | Liability | | | | $ | 73.80 | | | | July 2021 | | | | | 212,801 | | | | | | — | | | | | | — | | | | | | 212,801 | | |
Non-tradable pre-funded warrants | | | Equity | | | | $ | 0.15 | | | | July 2023 | | | | | 394 | | | | | | — | | | | | | — | | | | | | 394 | | |
Non-tradable warrants | | | Equity | | | | $ | 1.60 | | | | December 2022 | | | | | 392,834 | | | | | | — | | | | | | — | | | | | | 392,834 | | |
Non-tradable warrants | | | Equity | | | | $ | 14.10 | | | | March 2021 | | | | | 5,000 | | | | | | — | | | | | | — | | | | | | 5,000 | | |
Non-tradable warrants | | | Equity | | | | $ | 21.15 | | | | March 2021 | | | | | 8,333 | | | | | | — | | | | | | — | | | | | | 8,333 | | |
Non-tradable warrants | | | Equity | | | | $ | 7.7895 | | | | June 2021 | | | | | 15,000 | | | | | | — | | | | | | — | | | | | | 15,000 | | |
Non-tradable pre-funded warrants | | | Equity | | | | $ | 0.15 | | | | none | | | | | 52,834 | | | | | | — | | | | | | — | | | | | | 52,834 | | |
Non-tradable warrants | | | Equity | | | | $ | 1.600 | | | | December 2022 | | | | | 1,806,104 | | | | | | — | | | | | | — | | | | | | 1,806,104 | | |
Description | | | Classification | | | Exercise Price | | | Expiration Date | | | Balance December 31, 2019 | | | Warrants Issued | | | Warrants Exercised | | | Balance December 31, 2020 | | | |||||||||||||||||
Non-tradable pre-funded warrants | | | Equity | | | | $ | 0.15 | | | | none | | | | | 74,617 | | | | | | — | | | | | | — | | | | | | 74,617 | | | | ||
Non-tradable warrants | | | Equity | | | | $ | 2.00 | | | | September 2023 | | | | | 109,585 | | | | | | — | | | | | | — | | | | | | 109,585 | | | | ||
Non-tradable pre-funded warrants | | | Equity | | | | $ | 0.0001 | | | | none | | | | | 1,250,000 | | | | | | — | | | | | | (1,250,000) | | | | | | — | | | | ||
Non-tradable warrants | | | Equity | | | | $ | 0.20 | | | | November 2024 | | | | | 41,037,000 | | | | | | — | | | | | | (34,894,500) | | | | | | 6,142,500 | | | | | |
Non-tradable warrants | | | Equity | | | | $ | 0.250 | | | | November 2024 | | | | | 2,521,875 | | | | | | — | | | | | | (2,521,875) | | | | | | — | | | | ||
Non-tradable warrants | | | Equity | | | | $ | 0.287 | | | | December 2024 | | | | | 3,581,662 | | | | | | — | | | | | | (3,581,662) | | | | | | — | | | | ||
Non-tradable warrants | | | Equity | | | | $ | 0.43625 | | | | December 2024 | | | | | 716,332 | | | | | | — | | | | | | (462,034) | | | | | | 254,298 | | | | ||
Non-tradable warrants | | | Equity | | | | $ | 0.298 | | | | December 2024 | | | | | 3,469,716 | | | | | | — | | | | | | (3,469,716) | | | | | | — | | | | ||
Non-tradable warrants | | | Equity | | | | $ | 0.45030 | | | | December 2024 | | | | | 693,943 | | | | | | — | | | | | | — | | | | | | 693,943 | | | | ||
Non-tradable warrants | | | Equity | | | | $ | 0.45190 | | | | December 2023 | | | | | — | | | | | | 1,383,126 | | | | | | (933,610) | | | | | | 449,516 | | | | ||
| | | | | | | | | | | | | | | | | 55,954,486 | | | | | | 1,383,126 | | | | | | (47,113,397) | | | | | | 10,224,215 | | | | ||
|
| | | Year ended December 31, | | |||||||||
| | | 2020 | | | 2019 | | ||||||
Basic and diluted net loss per share of common stock: | | | | | | | | | | | | | |
Net loss attributable to Onconova Therapeutics, Inc. | | | | $ | (25,157,000) | | | | | $ | (21,503,000) | | |
Weighted average shares of common stock outstanding | | | | | 174,035,872 | | | | | | 14,384,476 | | |
Net loss per share of common stock – basic and diluted | | | | $ | (0.14) | | | | | $ | (1.49) | | |
| | | December 31, | | |||||||||
| | | 2020 | | | 2019 | | ||||||
Warrants | | | | | 10,096,370 | | | | | | 54,609,799 | | |
Stock options | | | | | 869,095 | | | | | | 994,453 | | |
| | | | | 10,965,465 | | | | | | 55,604,252 | | |
| | | Year ended December 31, | | |||||||||
| | | 2020 | | | 2019 | | ||||||
Symbio | | | | | | | | | | | | | |
Upfront license fee recognition over time | | | | $ | 226,000 | | | | | $ | 227,000 | | |
Supplies | | | | | 5,000 | | | | | | 55,000 | | |
HanX – rigosertib | | | | | | | | | | | | | |
Upfront license payment recognized at a point in time | | | | | — | | | | | | 1,751,000 | | |
Knight | | | | | | | | | | | | | |
Upfront license payment recognized at a point it time | | | | | — | | | | | | 100,000 | | |
STA | | | | | | | | | | | | | |
Upfront license payment recognized at a point it time | | | | | — | | | | | | 50,000 | | |
| | | | $ | 231,000 | | | | | $ | 2,183,000 | | |
| | | Symbio Upfront Payment | | |||
Deferred balance at December 31, 2019 | | | | $ | 3,921,000 | | |
Recognition to revenue | | | | | 226,000 | | |
Deferred balance at December 31, 2020 | | | | $ | 3,695,000 | | |
| | | December 31, | | |||||||||
| | | 2020 | | | 2019 | | ||||||
Research and development | | | | $ | 189,000 | | | | | $ | 321,000 | | |
Manufacturing | | | | | 90,000 | | | | | | 25,000 | | |
Insurance | | | | | 263,000 | | | | | | 164,000 | | |
Other | | | | | 180,000 | | | | | | 140,000 | | |
| | | | $ | 722,000 | | | | | $ | 650,000 | | |
| | | December 31, | | |||||||||
| | | 2020 | | | 2019 | | ||||||
Research and development | | | | $ | 2,541,000 | | | | | $ | 2,016,000 | | |
Employee compensation | | | | | 2,239,000 | | | | | | 1,537,000 | | |
Professional fees | | | | | 182,000 | | | | | | 242,000 | | |
| | | | $ | 4,962,000 | | | | | $ | 3,795,000 | | |
| | | Fair Value Measurement as of: | | | |||||||||||||||||||||||||||||||||||||||||||||||
| | | December 31, 2020 | | | December 31, 2019 | | | ||||||||||||||||||||||||||||||||||||||||||||
| | | Level 1 | | | Level 2 | | | Level 3 | | | Balance | | | Level 1 | | | Level 2 | | | Level 3 | | | Balance | | | ||||||||||||||||||||||||||
Tradable warrants liability | | | | $ | 321,000 | | | | | $ | — | | | | | $ | — | | | | | $ | 321,000 | | | | | $ | 113,000 | | | | | $ | — | | | | | $ | — | | | | | $ | 113,000 | | | | ||
Non-tradable warrants liability | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | ||
Total | | | | $ | 321,000 | | | | | $ | — | | | | | $ | — | | | | | $ | 321,000 | | | | | $ | 113,000 | | | | | $ | — | | | | | $ | — | | | | | $ | 113,000 | | | | | |
| | | December 31, | | |||||||||
| | | 2020 | | | 2019 | | ||||||
Domestic | | | | $ | (25,167,000) | | | | | $ | (21,527,000) | | |
Foreign | | | | | 14,000 | | | | | | 34,000 | | |
| | | | $ | (25,153,000) | | | | | $ | (21,493,000) | | |
| | | December 31, | | |||||||||
| | | 2020 | | | 2019 | | ||||||
Current | | | | | | | | | | | | | |
US Federal | | | | $ | — | | | | | $ | — | | |
State and Local | | | | | — | | | | | | — | | |
Foreign | | | | | 4,000 | | | | | | 10,000 | | |
Total Current | | | | $ | 4,000 | | | | | $ | 10,000 | | |
Deferred | | | | | | | | | | | | | |
US Federal | | | | $ | — | | | | | $ | — | | |
State and Local | | | | | — | | | | | | — | | |
Foreign | | | | | — | | | | | | — | | |
Total Deferred | | | | $ | — | | | | | $ | — | | |
Total (Benefit) Expense | | | | $ | 4,000 | | | | | $ | 10,000 | | |
| | | December 31, | | |||||||||
| | | 2020 | | | 2019 | | ||||||
Deferred tax assets: | | | | | | | | | | | | | |
Net operating loss carryovers | | | | $ | 76,631,000 | | | | | $ | 69,640,000 | | |
R&D tax credits | | | | | 87,529,000 | | | | | | 84,899,000 | | |
Non-qualified stock options | | | | | 2,448,000 | | | | | | 4,969,000 | | |
Deferred revenue | | | | | 1,068,000 | | | | | | 1,133,000 | | |
Charitable contributions | | | | | 4,000 | | | | | | 4,000 | | |
Accrued expenses | | | | | 647,000 | | | | | | 429,000 | | |
Fixed assets | | | | | — | | | | | | 88,000 | | |
Stock Appreciation Rights | | | | | 19,000 | | | | | | — | | |
Deferred tax assets | | | | | 168,346,000 | | | | | | 161,162,000 | | |
Deferred tax liabilities: Fixed Assets | | | | | (2,000) | | | | | | — | | |
Deferred tax liabilities | | | | | (2,000) | | | | | | — | | |
Less valuation allowance | | | | | (166,344,000) | | | | | | (161,025,000) | | |
Net deferred tax assets | | | | $ | — | | | | | $ | 137,000 | | |
| | | December 31, | | |||||||||
| | | 2020 | | | 2019 | | ||||||
Federal income tax expense at statutory rate | | | | | 21.0% | | | | | | 21.0% | | |
Permanent items | | | | | (0.2) | | | | | | (0.1) | | |
State income tax, net of federal benefit | | | | | 7.8 | | | | | | 9.0 | | |
Tax credits | | | | | 11.0 | | | | | | 12.3 | | |
Change in valuation allowance | | | | | (29.1) | | | | | | (42.3) | | |
Deferred Tax Adjustment | | | | | (10.5) | | | | | | — | | |
Other | | | | | (0.1) | | | | | | — | | |
Effective income tax rate | | | | | (0.1)% | | | | | | (0.1)% | | |
| | | Year ended December 31, | | |||||||||
| | | 2020 | | | 2019 | | ||||||
General and administrative | | | | $ | 160,000 | | | | | $ | 721,000 | | |
Research and development | | | | | 209,000 | | | | | | 327,000 | | |
| | | | $ | 369,000 | | | | | $ | 1,048,000 | | |
| | | | | | | | | Options Outstanding | | |||||||||||||||||||||
| | | Shares Available for Grant | | | Number of Shares | | | Weighted- Average Exercise Price | | | Weighted Average Remaining Contractual Term (in years) | | | Aggregate Intrinsic Value | | |||||||||||||||
Balance, December 31, 2019 | | | | | 59,731 | | | | | | 994,453 | | | | | $ | 27.37 | | | | | | 9.32 | | | | | $ | — | | |
Authorized | | | | | — | | | | | | — | | | | | | | | | | | | | | | | | | | | |
Granted | | | | | (68,250) | | | | | | 68,250 | | | | | $ | 0.366 | | | | | | 9.54 | | | | | | | | |
Exercised | | | | | — | | | | | | — | | | | | $ | — | | | | | | | | | | | | | | |
Forfeitures | | | | | 193,608 | | | | | | (193,608) | | | | | $ | 31.52 | | | | | | 8.46 | | | | | | | | |
Balance, December 31, 2020 | | | | | 185,089 | | | | | | 869,095 | | | | | $ | 24.58 | | | | | | 8.38 | | | | | $ | — | | |
Vested or expected to vest, December 31, 2020 | | | | | | | | | | | 853,200 | | | | | $ | 43.39 | | | | | | 7.98 | | | | | $ | — | | |
Exercisable at December 31, 2020 | | | | | | | | | | | 485,168 | | | | | $ | 43.39 | | | | | | 7.98 | | | | | $ | — | | |
Exercise Price | | | Shares | | | Exercisable | | ||||||
$0.31 | | | | | 553,500 | | | | | | 203,672 | | |
$3.39 – $3.41 | | | | | 30,332 | | | | | | 30,332 | | |
$4.34 – $7.05 | | | | | 226,414 | | | | | | 192,487 | | |
$16.35 – $97.50 | | | | | 44,448 | | | | | | 44,276 | | |
$222.00 – $225.00 | | | | | 1,729 | | | | | | 1,729 | | |
$348.00 – $597.00 | | | | | 4,299 | | | | | | 4,299 | | |
$651.00 – $1,129.50 | | | | | 2,176 | | | | | | 2,176 | | |
$1,992.00 – $2,268.00 | | | | | 5,862 | | | | | | 5,862 | | |
$4,156.50 – $4,371.00 | | | | | 335 | | | | | | 335 | | |
| | | | | 869,095 | | | | | | 485,168 | | |
| | | Year ended December 31, | | |||||||||
| | | 2020 | | | 2019 | | ||||||
Risk-free interest rate | | | | | 0.45% | | | | | | 1.77% | | |
Expected volatility | | | | | 105.14% | | | | | | 103.01% | | |
Expected term | | | 6.00 years | | | 5.99 years | | ||||||
Expected dividend yield | | | | | 0% | | | | | | 0% | | |
Weighted average grant date fair value | | | | $ | 0.25 | | | | | $ | 0.44 | | |