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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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¨
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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DELAWARE
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04-3505116
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification No.)
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Title of Each Class
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Trading Symbol(s)
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Name of Each Exchange on Which Registered
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Common Stock, $0.01 par value per share
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CRIS
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Nasdaq Global Market
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Large accelerated filer ¨
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Accelerated filer ¨
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Non-accelerated filer x
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Smaller reporting company x
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Emerging growth company ¨
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PART I
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ITEM 1.
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ITEM 1A.
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ITEM 1B.
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ITEM 2.
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ITEM 3.
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ITEM 4.
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PART II
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ITEM 5.
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ITEM 6.
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ITEM 7.
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ITEM 7A.
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ITEM 8.
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ITEM 9.
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ITEM 9A.
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ITEM 9B.
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PART III
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ITEM 10.
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ITEM 11.
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ITEM 12.
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ITEM 13.
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ITEM 14.
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PART IV
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ITEM 15.
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ITEM 16.
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ITEM 1.
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BUSINESS
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CA-4948, which is being tested in a Phase 1 dose escalating clinical trial in patients with non-Hodgkin lymphomas, including those with Myeloid Differentiation Primary Response Protein 88, or MYD88 alterations. We reported preliminary clinical data from the study in December 2019. We are currently planning to initiate a separate Phase 1 trial for acute myeloid leukemia and myelodysplastic syndromes patients in the first half of 2020.
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CI-8993, a monoclonal antibody designed to antagonize the V-domain Ig suppressor of T cell activation, or VISTA signaling pathway, which we plan to begin clinical testing in a Phase 1a/1b trial in 2020.
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Fimepinostat, which is currently being explored in clinical studies in patients with MYC-altered diffuse large B-cell lymphoma, or DLBCL and solid tumors and has been granted Orphan Drug Designation and Fast Track Designation for the treatment of DLBCL by the U.S. Food and Drug Administration, or FDA in April 2015 and May 2018, respectively. We began enrollment in a Phase 1 combination study with venetoclax in DLBCL patients, including patients with translocations in both MYC and the BCL2 gene, also referred to as double-hit lymphoma, or high-grade B-cell lymphoma, or HGBL. We reported preliminary clinical data from this combination study in December 2019. In March 2020, we announced that although we observed no significant drug-drug interaction in our Phase 1 study of fimepinostat in combination with venetoclax, we did not see an efficacy signal that would warrant continuation of the study. Accordingly, no further patients will be enrolled in this study. We are currently evaluating future studies for fimepinostat.
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Our pipeline includes CA-170 for which we announced initial data from a clinical study in patients with mesothelioma in conjunction with the Society of lmmunotherapy of Cancer conference in November 2019. Based on this data, no further patients will be enrolled in the study. We are currently evaluating future studies for CA-170. In February 2020, we and Aurigene further amended our collaboration agreement. Under the terms of the amended agreement, Aurigene will fund and conduct a Phase 2b/3 randomized study evaluating CA-170, in combination with chemoradiation, in approximately 240 patients with non-squamous non-small cell lung cancer, or nsNSCLC. In turn, Aurigene receives rights to develop and commercialize CA-170 in Asia, in addition to its existing rights in India and Russia, based on the terms of the original agreement. We retain U.S., European Union, and rest of world rights to CA-170, and are entitled to receive royalty payments on potential future sales of CA-170 in Asia.
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1.
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IRAK4 Program - a precision oncology program of small molecule inhibitors of IRAK4. The development candidate is CA-4948, an orally available small molecule inhibitor of IRAK4.
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2.
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PD1/VISTA Program - an immuno-oncology program of small molecule antagonists of PD1 and VISTA immune checkpoint pathways. The development candidate is CA-170, an orally available small molecule antagonist of VISTA and PDL1.
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3.
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PD1/TIM3 Program - an immuno-oncology program of small molecule antagonists of PD1 and TIM3 immune checkpoint pathways. The development candidate is CA-327, an orally available small molecule antagonist of PDL1 and TIM3.
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4.
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In March 2018, we exercised our option to license a fourth program, which is an immuno-oncology program.
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1.
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IRAK4 Program - a precision oncology program of small molecule inhibitors of IRAK4. The development candidate is CA-4948, an orally available small molecule inhibitor of IRAK4.
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2.
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PD1/VISTA Program - an immuno-oncology program of small molecule antagonists of PD1 and VISTA immune checkpoint pathways. The development candidate is CA-170, an orally available small molecule antagonist of VISTA and PDL1.
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3.
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PD1/TIM3 Program - an immuno-oncology program of small molecule antagonists of PD1 and TIM3 immune checkpoint pathways. The development candidate is CA-327, an orally available small molecule antagonist of PDL1 and TIM3.
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4.
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In March 2018, we exercised our option to license a fourth program, which is an immuno-oncology program.
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with respect to amounts that we and our affiliates receive from sublicensees under a licensed program in the U.S. or the European Union, a declining percentage of non-royalty sublicense revenues that is dependent on the stage of the most advanced product for such licensed program at the time the sublicense is granted, including, for example 25% of such amounts following our initiation of a Phase 2 clinical study and 15% of such amounts after initiation of the first pivotal study. This sharing will also extend to royalties that we receive from sublicensees, subject to minimum royalty percentage rates that we are obligated to pay to Aurigene, which generally range from mid-to-high single-digit royalty percentage rates up to 10%;
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with respect to sublicensing revenues we and our affiliates receive from sublicensees under a licensed program in Asia, 50% of such sublicensing revenues, including both non-royalty sublicensee revenues and royalties that we receive from sublicensees; and
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with respect to non-royalty sublicensing revenues we and our affiliates receive from sublicensees under a licensed program outside of the U.S., the European Union and Asia, a percentage of such non-royalty sublicense revenues ranging from 30% to 50%. We are also obligated to share 50% of royalties that we receive from sublicensees that we receive in these territories.
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our license with respect to any licensed program that is not a terminated program (defined below), either in our entire territory or in countries within our territory outside of the terminated region (defined below), as applicable, shall continue in full force and effect, subject to all terms and conditions of the collaboration agreement, including our payment obligations;
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our license with respect to any terminated program, either in our entire territory or in the terminated region, as applicable, shall terminate and revert to Aurigene;
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we will grant Aurigene a perpetual, royalty-free (except for pass-through royalties and milestone payments payable by us under licenses to third-party patent rights with respect to products developed or commercialized by or on behalf of Aurigene) license, with the right to sublicense, under our relevant patent rights and other technology solely to develop, manufacture and commercialize compounds and products for any terminated program, either in our entire territory or in the terminated region, as applicable. The foregoing license will be non-exclusive with respect to our patent rights and exclusive with respect to our other technology;
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we will grant to Aurigene a right of first negotiation, exercisable within 90 days after termination, to obtain an exclusive, royalty-bearing license, with the right to sublicense, under our relevant patent rights solely to develop, manufacture and commercialize compounds and products for any terminated program, either in our entire territory or in the terminated region, as applicable, upon commercially reasonable terms and conditions to be negotiated in good faith by the parties;
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we will perform other specified activities and actions reasonably necessary for Aurigene to develop, manufacture and commercialize compounds and products for any terminated program, either in our entire territory or in the terminated region, as applicable; and
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the applicable license to Aurigene will survive termination.
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completion of preclinical laboratory tests, animal studies and formulation studies in compliance with the FDA’s good laboratory practice, or GLP, regulations;
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submission to the FDA of an IND, which must take effect before human clinical trials may begin;
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approval by an independent institutional review board, or IRB, representing each clinical site before each clinical trial may be initiated;
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performance of adequate and well-controlled human clinical trials in accordance with good clinical practices, or GCP, to establish the safety and efficacy of the proposed drug product for each indication;
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preparation and submission to the FDA of a new drug application, or NDA, requesting marketing for one or more proposed indications;
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review of the candidate product by an FDA advisory committee, where appropriate or if applicable;
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satisfactory completion of one or more FDA inspections of the manufacturing facility or facilities at which the product, or components thereof, are produced to assess compliance with current good manufacturing practices, or cGMP, requirements and to assure that the facilities, methods and controls are adequate to preserve the product’s identity, strength, quality and purity;
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satisfactory completion of FDA audits of clinical trial sites to assure compliance with GCPs and the integrity of the clinical data;
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payment of user fees and securing FDA approval of the NDA; and
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compliance with any post approval requirements, including the potential requirement to implement a Risk Evaluation and Mitigation Strategy, or REMS, and the potential requirement to conduct post approval studies required by the FDA.
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Phase 1. The drug is initially introduced into a small number of healthy human subjects or, in certain indications such as cancer, patients with the target disease or condition (e.g., cancer) and tested for safety, dosage tolerance, absorption, distribution, metabolism, excretion and, if possible, to gain an early indication of its effectiveness and to determine optimal dosage.
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Phase 2. The drug is administered to a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance and optimal dosage, and regimen.
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Phase 3. These clinical trials are commonly referred to as “pivotal” studies, which denotes a study which presents the data that the FDA or other relevant regulatory agency will use to determine whether or not to approve a drug. The drug is administered to an expanded patient population, generally at geographically dispersed clinical trial sites, in
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Phase 4. Post approval studies may be required after initial marketing approval. These studies are used to gain additional experience from the treatment of patients in the intended therapeutic indication.
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restrictions on the marketing or manufacturing of the product, suspension of the approval, or complete withdrawal of the product from the market or product recalls;
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fines, warning letters or holds on post approval clinical trials;
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refusal of the FDA to approve pending NDAs or supplements to approved NDAs, or suspension or revocation of product license approvals;
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product seizure or detention, or refusal to permit the import or export of products; or
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injunctions or the imposition of civil or criminal penalties.
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the required patent information has not been filed;
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the listed patent has expired;
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the listed patent has not expired, but will expire on a particular date and approval is sought after patent expiration; or
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the listed patent is invalid, unenforceable or will not be infringed by the new product.
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the federal Anti-Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, paying, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made, in whole or in part, under a federal healthcare program such as Medicare and Medicaid;
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the federal civil and criminal false claims laws, including the civil False Claims Act, and civil monetary penalties laws, which prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false, fictitious or fraudulent or knowingly making, using or causing to made or used a false record or statement to avoid, decrease or conceal an obligation to pay money to the federal government;
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the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created additional federal criminal laws that prohibit, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;
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HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and their respective implementing regulations, including the Final Omnibus Rule published in January 2013, which impose obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;
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the federal false statements statute prohibits knowingly and willfully falsifying, concealing ·or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items or services;
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the Foreign Corrupt Practices Act, or FCPA, which prohibits companies and their intermediaries from making, or offering or promising to make improper payments to non-U.S. officials for the purpose of obtaining or retaining business or otherwise seeking favorable treatment; and
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the federal transparency requirements known as the federal Physician Payments Sunshine Act, under the Patient Protection and Affordable Care Act, as amended by the Health Care Education Reconciliation Act, or the Affordable Care Act, or ACA, which requires certain manufacturers of drugs, devices, biologics and medical supplies to report annually to the Centers for Medicare & Medicaid Services, or CMS, within the United States Department of Health and Human Services, information related to payments and other transfers of value made by that entity to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members; and analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws,
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an annual, nondeductible fee on any entity that manufactures or imports specified branded prescription drugs and biologic agents, apportioned among these entities according to their market share in certain government healthcare programs, although this fee would not apply to sales of certain products approved exclusively for orphan indications;
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expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to certain individuals with income at or below 133% of the federal poverty level, thereby potentially increasing a manufacturer’s Medicaid rebate liability;
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expanded manufacturers’ rebate liability under the Medicaid Drug Rebate Program by increasing the minimum rebate for both branded and generic drugs and revising the definition of “average manufacturer price,” or AMP, for calculating and reporting Medicaid drug rebates on outpatient prescription drug prices and extending rebate liability to prescriptions for individuals enrolled in Medicare Advantage plans;
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addressed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected;
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expanded the types of entities eligible for the 340B drug discount program;
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established the Medicare Part D coverage gap discount program by requiring manufacturers to provide a 50% point-of-sale-discount off the negotiated price of applicable brand drugs to eligible beneficiaries during their coverage gap period as a condition for the manufacturers’ outpatient drugs to be covered under Medicare Part D;
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a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research;
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the Independent Payment Advisory Board, or IPAB, which has authority to recommend certain changes to the Medicare program to reduce expenditures by the program that could result in reduced payments for prescription drugs. However, the IPAB implementation has been not been clearly defined. The ACA provided that under certain circumstances, IPAB recommendations will become law unless Congress enacts legislation that will achieve the same or greater Medicare cost savings; and
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established the Center for Medicare and Medicaid Innovation within CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending. Funding has been allocated to support the mission of the Center for Medicare and Medicaid Innovation from 2011 to 2019.
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Name
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Age
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Position
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James Dentzer
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53
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President and Chief Executive Officer
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Robert Martell, M.D., Ph.D.
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57
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Head of Research and Development
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William Steinkrauss
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34
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Chief Financial Officer
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James Dentzer
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Mr. Dentzer has served on our board of directors and as our President, Chief Executive Officer, Secretary and Treasurer since September 2018. From March 2018 to September 2018, Mr. Dentzer served as our Chief Operating Officer, Chief Financial Officer, Secretary, and Treasurer. Mr. Dentzer joined the Company in March 2016 as Chief Administrative Officer, Chief Financial Officer, Secretary, and Treasurer. From December 2013 to December 2015, Mr. Dentzer served as Chief Financial Officer of Dicerna Pharmaceuticals, Inc., an RNA interference based biopharmaceutical company. From March 2010 to December 2013, Mr. Dentzer was the Chief Financial Officer of Valeritas, Inc., a commercial-stage medical technology company. From October 2006 to October 2009, Mr. Dentzer was the Chief Financial Officer of Amicus Therapeutics, Inc., a biotechnology company. In prior positions, Mr. Dentzer spent six years as corporate controller of Biogen and six years in various senior financial roles at E.I. du Pont de Nemours and Company in the U.S. and Asia. Mr. Dentzer holds a B.A. in philosophy from Boston College and an M.B.A. from the University of Chicago.
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Robert Martell, M.D., Ph.D.
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Dr. Martell, M.D., Ph.D. served on our Board of Directors from 2011 to 2018, and as Head of Research and Development from 2018 to present. He is also co-founder of Epi-Cure Pharmaceuticals, a privately held early-stage biotechnology company, and served as its president and member of board of directors from 2016 to 2018. Dr. Martell served as Chief Medical Officer of Tesaro, Inc., a biopharmaceutical company developing Zejula and Varubi from 2012 to 2015; as Chief Medical Officer at MethylGene, a publicly traded biopharmaceutical company focused on cancer therapeutics from 2005 to 2009; as Director of Oncology Global Clinical Research at Bristol-Myers Squibb, a biopharmaceutical company developing Sprycel, Erbitux and Ixempra from 2002 to 2005; and as Associate/Deputy Director at Bayer Corporation Pharmaceutical Division developing Nexavar from 2000 to 2002. In addition, Dr. Martell has held a number of academic positions, including at Tufts Medical Center since 2009, where he has served in various roles including Associate Chief in the Division of Hematology/Oncology, Director of the Neely Center for Clinical Cancer Research, Leader of the Cancer Center’s Program in Experimental Therapeutics and Attending Physician; at Yale University School of Medicine as Assistant Clinical Professor of Oncology from 2001 to 2005; and as Assistant Professor at Duke Medical Center from 1998 to 2000. Dr. Martell received a B.A. in chemistry from Kalamazoo College, a Ph.D. in Pharmacology from University of Michigan and an M.D. from Wayne State University. He completed his Internal Medicine internship and residency at Duke University Medical Center, and his Fellowship in Medical Oncology also at Duke.
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William Steinkrauss
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Mr. Steinkrauss has served as our Chief Financial Officer since September 2019. Prior to that, Mr. Steinkrauss served as vice president, treasurer and assistant secretary from January 2019 to September 2019, and prior to that served as our corporate controller, senior director of finance and assistant treasurer from August 2016 until January 2019. Mr. Steinkrauss previously served as director of technical accounting and reporting of Ovascience, Inc., a biotechnology company focused on infertility, from June 2015 to August 2016. Prior to that, he was senior manager of technical accounting at Cubist Pharmaceuticals, Inc., a biopharmaceutical company, from November 2012 to May 2015. Prior to joining Cubist Pharmaceuticals, Inc., Mr. Steinkrauss worked within the transaction services and assurance practices at PricewaterhouseCoopers, LLP. Mr. Steinkrauss holds a B.S. in accounting and finance and a M.S. in accounting from Boston College. Mr. Steinkrauss is a certified public accountant.
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ITEM 1A.
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RISK FACTORS
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unanticipated costs in our research and development programs;
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the timing and cost of obtaining regulatory approvals for our drug candidates and maintaining compliance with
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regulatory requirements;
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the timing and amount of option exercise fees, milestone payments, royalties and other payments, including payments
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due to licensors, including Aurigene and ImmuNext if we exercise our option under the ImmuNext Agreement, for
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patent rights and technology used in our drug development programs;
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the costs of commercialization activities for any of our drug candidates that receive marketing approval, to the extent
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such costs are our responsibility, including the costs and timing of establishing drug sales, marketing, distribution and
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manufacturing capabilities;
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unplanned costs to prepare, file, prosecute, defend and enforce patent claims and other patent-related costs, including
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litigation costs and technology license fees; and
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unexpected losses in our cash investments or an inability to otherwise liquidate our cash investments due to
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unfavorable conditions in the capital markets.
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our ability to continue as a going concern.
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continue to develop and conduct clinical trials with respect to drug candidates;
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seek to identify and develop additional drug candidates;
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acquire or in-license other drug candidates or technologies;
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seek regulatory and marketing approvals for our drug candidates that successfully complete clinical trials, if any;
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establish sales, marketing, distribution and other commercial infrastructure in the future to commercialize various drugs for which we may obtain marketing approval, if any;
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require the manufacture of larger quantities of drug candidates for clinical development and, potentially, commercialization;
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maintain, expand, and protect our intellectual property portfolio;
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hire and retain additional personnel, such as clinical, quality control and scientific personnel; and
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add equipment and physical infrastructure as may be required to support our research and development programs.
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any royalty and royalty related payments to be remitted into a certain Curis Royalty designated account controlled by the Agent pursuant to a control agreement, referred to as the royalty account, into which all royalty and royalty related payments must be paid by Curis or Curis Royalty are not so remitted in accordance with the Oberland Purchase Agreement;
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any representation or warranty made by Curis or Curis Royalty in the Oberland Purchase Agreement or any other transaction document proves to be incorrect or misleading in any material respect when made;
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a default by Curis or Curis Royalty in the performance of affirmative and negative covenants set forth in the Oberland Purchase Agreement or any other transaction document;
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a default by Curis in the performance or observance of its indemnity obligations under the Oberland Purchase Agreement;
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the failure by Genentech to pay material amounts owed under the Genentech collaboration agreement because of an actual breach or default by Curis under the Genentech collaboration agreement;
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the failure of the security agreement to create a valid and perfected first priority security interest in any of the collateral;
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a material breach or default by Curis under our agreement with Curis Royalty pursuant to which we transferred our rights to the royalty revenues under the Genentech collaboration agreement to Curis Royalty;
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the voluntary or involuntary commencement of bankruptcy proceedings by either Curis or Curis Royalty and other insolvency related events;
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any materially adverse effect on the binding nature of any of the Oberland Purchase Agreement, Security Agreement, Pledge Agreement or other transaction documents, the Genentech collaboration agreement or our agreement with Curis Royalty;
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any person shall be designated as an independent director of Curis Royalty other than in accordance with Curis Royalty’s limited liability company operating agreement; or
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Curis shall at any time cease to own, of record and beneficially, 100% of the equity interests in Curis Royalty.
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payments we may be required to make to collaborators such as Aurigene and ImmuNext to exercise license rights and satisfy milestones and royalty obligations;
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the status of, and level of expenses incurred in connection with, our programs, including development costs relating to CA-4948, CI-8993, and fimepinostat as well as funding programs that we have licensed or may in the future license and develop under our collaborations with Aurigene and ImmuNext;
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fluctuations in sales of Erivedge and related royalty and milestone payments, including fluctuations resulting from the sales of competing drug products such as sonidegib, which is approved in the U.S. and Europe for the treatment of locally advanced BCC and is now being marketed and sold by Sun Pharmaceuticals;
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any intellectual property infringement lawsuit or other litigation in which we may become involved;
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the implementation of restructuring and cost-savings strategies;
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the occurrence of an event of default under the Oberland Purchase Agreement;
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the implementation or termination of collaboration, licensing, manufacturing or other material agreements with third-parties, and non-recurring revenue or expenses under any such agreement; and
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compliance with regulatory requirements.
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successful enrollment in, and completion of, ongoing and future clinical trials of CA-4948 and CI-8993 and other compounds that we may develop under our collaboration and license agreements with Aurigene and ImmuNext;
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Aurigene’s ability to successfully discover and preclinically develop other drug candidates under the collaboration agreement;
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a safety, tolerability and efficacy profile that is satisfactory to the FDA or any comparable foreign regulatory authority for marketing approval;
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receipt of requisite marketing approvals from applicable regulatory authorities;
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the extent of any required post marketing approval commitments to applicable regulatory authorities;
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establishment of supply arrangements with third-party raw materials suppliers and manufacturers;
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establishment of arrangements with third-party manufacturers to obtain finished drug products that is appropriately packaged for sale;
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adequate ongoing availability of raw materials and drug products for clinical development and any commercial sales;
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obtaining and maintaining patent, trade secret protection and regulatory exclusivity, both in the U.S. and internationally;
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protection of the rights in our intellectual property portfolio;
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successful launch of commercial sales following any marketing approval;
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a continued acceptable safety profile following any marketing approval;
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commercial acceptance by patients, the medical community and third-party payors; and
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our ability to compete with other therapies.
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incur additional unplanned costs;
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be delayed in obtaining marketing approval for our drug candidates;
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not obtain marketing approval at all;
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obtain approval for indications or patient populations that are not as broad as intended or desired;
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obtain approval with labeling that includes significant use or distribution restrictions or significant safety warnings, including boxed warnings;
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be subject to additional post marketing testing or other requirements; or
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be required to remove the drug from the market after obtaining marketing approval.
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regulators or institutional review boards may not authorize us, any collaborators or our or their investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;
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we, or any collaborators, may have delays in reaching or fail to reach agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites;
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clinical trials of our drug candidates may produce unfavorable or inconclusive results, including with respect to the safety, tolerability, efficacy, or pharmacodynamic and pharmacokinetic profile of the drug candidate;
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we, or any collaborators, may decide, or regulators may require us or them, to conduct additional clinical trials or abandon drug development programs;
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the number of patients required for clinical trials of our drug candidates may be larger than we, or any collaborators, anticipate, patient enrollment in these clinical trials may be slower than we, or any collaborators, anticipate or participants may drop out of these clinical trials at a higher rate than we, or any collaborators, anticipate;
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our estimates of the patient populations available for study may be higher than actual patient numbers and result in our inability to sufficiently enroll our trials;
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the cost of planned clinical trials of our drug candidates may be greater than we anticipate;
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our third-party contractors or those of any collaborators, including those manufacturing our drug candidates or components or ingredients thereof or conducting clinical trials on our behalf or on behalf of any collaborators, may fail to comply with regulatory requirements or meet their contractual obligations to us or any collaborators in a timely manner or at all;
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•
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patients that enroll in a clinical trial may misrepresent their eligibility to do so or may otherwise not comply with the clinical trial protocol, resulting in the need to drop the patients from the clinical trial, increase the needed enrollment size for the clinical trial or extend the clinical trial’s duration;
|
•
|
we, or any collaborators, may have to delay, suspend or terminate clinical trials of our drug candidates for various reasons, including a finding that the participants are being exposed to unacceptable health risks, undesirable side effects or other unexpected characteristics of the drug candidate such as an unfavorable pharmacodynamic or pharmacokinetic profile;
|
•
|
regulators or institutional review boards may require that we, or any collaborators, or our or their investigators suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements or their standards of conduct, a finding that the participants are being exposed to unacceptable health risks, undesirable side effects or other unexpected characteristics of the drug candidate or findings of undesirable effects caused by a chemically or mechanistically similar drug or drug candidate;
|
•
|
the FDA or comparable foreign regulatory authorities may disagree with our, or any collaborators’, clinical trial designs or our or their interpretation of data from preclinical studies and clinical trials;
|
•
|
the FDA or comparable foreign regulatory authorities may fail to approve or subsequently find fault with the manufacturing processes or facilities of third-party manufacturers with which we, or any collaborators, enter into agreements for clinical and commercial supplies;
|
•
|
the supply or quality of raw materials or manufactured drug candidates or other materials necessary to conduct clinical trials of our drug candidates may be insufficient, inadequate or not available at an acceptable cost, or we may experience interruptions in supply; and
|
•
|
the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient to obtain marketing approval.
|
•
|
the size and nature of the patient population;
|
•
|
the severity of the disease under investigation;
|
•
|
the availability of approved therapeutics for the relevant disease;
|
•
|
the proximity of patients to clinical sites;
|
•
|
the eligibility criteria and design for the trial;
|
•
|
efforts to facilitate timely enrollment;
|
•
|
competing clinical trials; and
|
•
|
clinicians’ and patients’ perceptions as to the potential advantages and risks of the drug being studied in relation to other available therapies, including any new drugs that may be approved for the indications we are investigating.
|
•
|
regulatory authorities may withdraw their approval of the drug or seize the drug;
|
•
|
we, or any future collaborators, may be required to recall the drug, change the way the drug is administered or conduct additional clinical trials;
|
•
|
additional restrictions may be imposed on the marketing of, or the manufacturing processes for, the particular drug;
|
•
|
we may be subject to fines, injunctions or the imposition of civil or criminal penalties;
|
•
|
regulatory authorities may require the addition of labeling statements, such as a “black box” warning or a contraindication;
|
•
|
we, or any future collaborators, may be required to create a Medication Guide outlining the risks of the previously unidentified side effects for distribution to patients;
|
•
|
we, or any future collaborators, could be sued and held liable for harm caused to patients;
|
•
|
the drug may become less competitive; and
|
•
|
our reputation may suffer.
|
•
|
the efficacy and safety of the drug;
|
•
|
the potential advantages of the drug compared to competitive therapies;
|
•
|
the prevalence and severity of any side effects;
|
•
|
whether the drug is designated under physician treatment guidelines as a first-, second- or third-line therapy;
|
•
|
our ability, or the ability of any future collaborators, to offer the drug for sale at competitive prices;
|
•
|
the drug’s convenience and ease of administration compared to alternative treatments;
|
•
|
the willingness of the target patient population to try, and of physicians to prescribe, the drug and patient adherence to the drug’s dosing regimen once prescribed;
|
•
|
limitations or warnings, including distribution or use restrictions, contained in the drug’s approved labeling;
|
•
|
the strength of sales, marketing and distribution support;
|
•
|
changes in the standard of care for the targeted indications for the drug; and
|
•
|
availability and amount of coverage and reimbursement from government payors, managed care plans and other third-party payors.
|
•
|
we may not be able to attract and build a significant and skilled marketing staff or sales force;
|
•
|
the cost of establishing a marketing staff or sales force may not be justifiable in light of the revenues generated by any particular drug; and
|
•
|
our direct sales and marketing efforts may not be successful.
|
•
|
decreased demand for our drug candidates or drugs that we may develop;
|
•
|
injury to our reputation and significant negative media attention;
|
•
|
withdrawal of clinical trial participants;
|
•
|
significant costs to defend resulting litigation;
|
•
|
substantial monetary awards to trial participants or patients;
|
•
|
loss of revenue;
|
•
|
reduced resources of our management to pursue our business strategy; and
|
•
|
the reduced ability or inability to commercialize any drugs that we may develop.
|
•
|
Erivedge becomes no longer accepted as safe, efficacious, cost-effective and preferable for the treatment of advanced BCC to current therapies in the medical community and by third-party payors;
|
•
|
Genentech and/or Roche fail to continue to apply the necessary financial resources and expertise to manufacturing, marketing and selling Erivedge for advanced BCC, and to regulatory approvals for this indication outside of the U.S.;
|
•
|
Genentech and/or Roche do not continue to develop and implement effective marketing, sales and distribution strategies and operations for development and commercialization of Erivedge for advanced BCC;
|
•
|
Genentech and/or Roche do not continue to develop, validate and maintain a commercially viable manufacturing process for Erivedge that is compliant with current good manufacturing practices;
|
•
|
Genentech and/or Roche do not successfully obtain third-party reimbursement and generate commercial demand that results in sales of Erivedge for advanced BCC in any geographic areas where requisite approvals have been, or may be, obtained;
|
•
|
we, Genentech, or Roche encounter third-party patent interference, derivation, inter partes review, post grant review, reexamination or patent infringement claims with respect to Erivedge;
|
•
|
Genentech and/or Roche do not comply with regulatory and legal requirements applicable to the sale of Erivedge for advanced BCC;
|
•
|
competing drug products are approved for the same indications as Erivedge, such as is the case with sonidegib, which is being marketed and sold by Sun Pharmaceutical, both in the U.S. and abroad for the treatment of adults with locally advanced BCC;
|
•
|
new safety risks are identified;
|
•
|
Erivedge does not demonstrate acceptable safety and efficacy in current or future clinical trials, or otherwise does not meet applicable regulatory standards for approval in indications other than advanced BCC;
|
•
|
Genentech and/or Roche determine to reprioritize Genentech’s commercial or development programs and reduce or terminate Genentech’s efforts on the development or commercialization of Erivedge; or
|
•
|
Genentech does not exercise its first right to maintain or defend intellectual property rights associated with Erivedge.
|
•
|
Our collaborators each have significant discretion in determining the efforts and resources that they will apply to their respective collaboration with us. If a collaborator fails to allocate sufficient time, attention and resources to our collaboration, the successful development and commercialization of drug candidates under such collaboration is likely to be adversely affected. For example, we are dependent on ImmuNext to conduct certain non-clinical research activities to support our expected Phase 1 clinical trial of CI-8993.
|
•
|
Our collaborators may develop and commercialize, either alone or with others, drugs that are similar to or competitive with the drug candidates that are the subject of our respective collaborations. For example, Genentech and Roche are involved in the commercialization of many cancer medicines and are seeking to develop several other cancer drug therapies, and Aurigene has other active cancer-focused discovery programs and has also entered into license agreements with other companies that focus on cancer therapies.
|
•
|
Our collaborators may change the focus of their development and commercialization efforts or pursue higher-priority programs.
|
•
|
Our collaborators may enter into one or more transactions with third-parties, including a merger, consolidation, reorganization, sale of substantial assets, sale of substantial stock or change of control. Any such transaction could divert the attention of our collaborative partner’s management and adversely affect its ability to retain and motivate key personnel who are important to the continued development of the programs under such collaboration. In addition, an acquirer could determine to reprioritize our collaborator’s development programs such that our collaborator ceases to diligently pursue the development of our programs, and/or terminates our collaboration.
|
•
|
Our collaborators may, under specified circumstances, terminate their collaborations with us on short notice and for circumstances outside of our control, which could make it difficult for us to attract new collaborators or adversely affect how we are perceived in the scientific, biotech, pharma and financial communities.
|
•
|
Our collaborators may utilize our intellectual property rights in such a way as to invite litigation that could jeopardize or invalidate our intellectual property rights, or expose us to potential liability.
|
•
|
Disputes may arise between collaborators and us regarding ownership of or other rights in the intellectual property generated in the course of the collaborations.
|
•
|
If any of our collaborators were to breach or terminate its arrangement with us, the development and commercialization of the affected drug candidate or program could be delayed, curtailed or terminated.
|
•
|
the development of certain of our current or future drug candidates may be terminated or delayed;
|
•
|
our cash expenditures related to development of certain of our current or future drug candidates would increase significantly and we may need to seek additional financing;
|
•
|
we may be required to hire additional employees or otherwise develop additional expertise, such as clinical, regulatory, sales and marketing expertise, for which we have not budgeted;
|
•
|
we will have to bear all of the risk related to the development of any such drug candidates; and
|
•
|
our future prospects may be adversely affected and our stock price could decline.
|
•
|
manufacturing delays if our third-party contractors give greater priority to the supply of other products over our product candidates or otherwise do not satisfactorily perform according to the terms of the agreements between us and them, or if unforeseen events in the manufacturing process arise;
|
•
|
the failure of third-party contractors to comply with applicable regulatory requirements;
|
•
|
the possible mislabeling of clinical supplies, potentially resulting in the wrong dose amounts being supplied or active drug or placebo not being properly identified;
|
•
|
the possibility of clinical supplies not being delivered to clinical sites on time, leading to clinical trial interruptions, or of drug supplies not being distributed to commercial vendors in a timely manner, resulting in lost sales; and
|
•
|
the possible misappropriation of our proprietary information, including our trade secrets and know-how.
|
•
|
we, and any collaborators, may not be able to initiate or continue certain preclinical and/or clinical trials of our drug candidates under development;
|
•
|
we, and any collaborators, may be delayed in submitting applications for regulatory approvals for our drug candidates; and
|
•
|
we, and any collaborators, may not be able to meet commercial demand for any approved drug products.
|
•
|
a diversion of management attention from our existing operations;
|
•
|
increased operating complexity of our business, requiring greater personnel and resources;
|
•
|
significant additional cash expenditures to expand our operations and acquire and integrate new businesses and technologies;
|
•
|
unanticipated expenses and potential delays related to integration of the operations, technology and other resources of any acquired companies;
|
•
|
uncertainty related to the value, benefits or legitimacy of intellectual property or technologies acquired;
|
•
|
retaining and assimilating key personnel and the potential impairment of relationships with our employees;
|
•
|
incurrence of debt, other liabilities and contingent liabilities, including potentially unknown contingent liabilities; and
|
•
|
dilutive stock issuances.
|
•
|
obtain patents to protect our technologies and discoveries;
|
•
|
protect trade secrets from disclosure to competitors;
|
•
|
operate without infringing upon the proprietary rights of others; and
|
•
|
prevent others from infringing on our proprietary rights.
|
•
|
initiation of litigation or other proceedings against third-parties to enforce our patent rights, to seek to invalidate the patents held by third-parties or to obtain a judgment that our drug candidates do not infringe such third-parties’ patents;
|
•
|
participation in interference and/or derivation proceedings to determine the priority of invention if our competitors file U.S. patent applications that claim technology also claimed by us;
|
•
|
initiation of opposition, reexamination, post grant review or inter partes review proceedings by third-parties that seek to limit or eliminate the scope of our patent protection;
|
•
|
initiation of litigation by third-parties claiming that our processes or drug candidates or the intended use of our drug candidates infringes their patent or other intellectual property rights; and
|
•
|
initiation of litigation by us or third-parties seeking to enforce contract rights relating to intellectual property that may be important to our business.
|
•
|
restrictions on such drugs, manufacturers or manufacturing processes;
|
•
|
restrictions on the labeling or marketing of a drug;
|
•
|
restrictions on drug distribution or use;
|
•
|
requirements to conduct post marketing studies or clinical trials;
|
•
|
warning letters or untitled letters;
|
•
|
withdrawal of the drugs from the market;
|
•
|
refusal to approve pending applications or supplements to approved applications that we submit;
|
•
|
recall of drugs;
|
•
|
restrictions on coverage by third-party payors;
|
•
|
fines, restitution or disgorgement of profits or revenues;
|
•
|
suspension or withdrawal of marketing approvals;
|
•
|
refusal to permit the import or export of drugs;
|
•
|
drug seizure; or
|
•
|
injunctions or the imposition of civil or criminal penalties.
|
•
|
an annual, non-deductible fee on any entity that manufactures or imports specified branded prescription drugs and biologic agents;
|
•
|
an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program;
|
•
|
expansion of healthcare fraud and abuse laws, including the civil False Claims Act and the federal Anti-Kickback Statute, new government investigative powers and enhanced penalties for noncompliance;
|
•
|
a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices to eligible beneficiaries during their coverage gap period, as a condition for a manufacturer’s outpatient drugs to be covered under Medicare Part D;
|
•
|
extension of manufacturers’ Medicaid rebate liability;
|
•
|
expansion of eligibility criteria for Medicaid programs;
|
•
|
expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program;
|
•
|
new requirements to report certain financial arrangements with physicians and teaching hospitals;
|
•
|
a new requirement to annually report drug samples that manufacturers and distributors provide to physicians; and
|
•
|
a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research.
|
•
|
the timing and result of clinical trials of our drug candidates;
|
•
|
the success of, and announcements regarding, existing and new technologies and/or drug candidates by us or our competitors;
|
•
|
regulatory actions with respect to our product candidates or our competitors’ products and product candidates;
|
•
|
market conditions in the biotechnology and pharmaceutical sectors;
|
•
|
rumors relating to us or our collaborators or competitors;
|
•
|
commencement or termination of collaborations for our development programs;
|
•
|
litigation or public concern about the safety of our drug candidates;
|
•
|
actual or anticipated variations in our quarterly operating results and any subsequent restatement of such results;
|
•
|
the amount and timing of any royalty revenue we receive from Genentech related to Erivedge;
|
•
|
actual or anticipated changes to our research and development plans;
|
•
|
deviations in our operating results from the estimates of securities analysts;
|
•
|
entering into new collaboration agreements or termination of existing collaboration agreements;
|
•
|
adverse results or delays in clinical trials being conducted by us or any collaborators;
|
•
|
any intellectual property disputes or other lawsuits involving us;
|
•
|
third-party sales of large blocks of our common stock;
|
•
|
sales of our common stock by our executive officers, directors or significant stockholders;
|
•
|
equity sales by us of our common stock to fund our operations;
|
•
|
the loss of any of our key scientific or management personnel;
|
•
|
FDA or international regulatory actions;
|
•
|
limited trading volume in our common stock;
|
•
|
general economic and market conditions, including recent adverse changes in the domestic and international financial markets; and
|
•
|
the other factors described in this “Risk Factors” section.
|
•
|
our or our collaborators’ preclinical studies and clinical trials may not advance or be completed in the time frames we or they announce or expect;
|
•
|
we or our collaborators may not make regulatory submissions, receive regulatory approvals or commercialize approved drugs as predicted; and
|
•
|
we or our collaborators may not be able to adhere to our or their current schedule for the achievement of key milestones under any programs.
|
•
|
the composition of our board of directors;
|
•
|
the adoption of amendments to our certificate of incorporation and bylaws;
|
•
|
the approval of mergers or sales of substantially all of our assets;
|
•
|
our capital structure and financing; and
|
•
|
the approval of contracts between us and these stockholders or their affiliates, which could involve conflicts of interest.
|
•
|
delaying, deferring or preventing a change in control of our company and making some transactions more difficult or impossible without the support of these stockholders, even if such transactions are beneficial to other stockholders;
|
•
|
impeding a merger, consolidation, takeover or other business combination involving our company; or
|
•
|
entrenching our management or the board of directors.
|
ITEM 1B.
|
UNRESOLVED STAFF COMMENTS
|
ITEM 2.
|
PROPERTIES
|
ITEM 3.
|
LEGAL PROCEEDINGS
|
ITEM 4.
|
MINE SAFETY DISCLOSURES
|
ITEM 5.
|
MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDERS MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
|
ITEM 6.
|
SELECTED FINANCIAL DATA
|
ITEM 7.
|
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
•
|
CA-4948, which is being tested in a dose escalating clinical trial in patients with non-Hodgkin lymphomas, including those with Myeloid Differentiation Primary Response Protein 88, or MYD88 alterations. We reported preliminary clinical data from the study in December 2019. We are currently planning to initiate a separate Phase 1 trial for acute myeloid leukemia and myelodysplastic syndromes patients in the first half of 2020.
|
•
|
CI-8993, a monoclonal antibody designed to antagonize the V-domain Ig suppressor of T cell activation, or VISTA signaling pathway, which we plan to begin clinical testing in a Phase 1a/1b trial in 2020.
|
•
|
Fimepinostat, which is currently being explored in clinical studies in patients with MYC-altered diffuse large B-cell lymphoma, or DLBCL and solid tumors and has been granted Orphan Drug Designation and Fast Track Designation for the treatment of DLBCL by the U.S. Food and Drug Administration, or FDA in April 2015 and May 2018, respectively. We began enrollment in a Phase 1 combination study with venetoclax in DLBCL patients, including patients with translocations in both MYC and the BCL2 gene, also referred to as double-hit lymphoma, or high-grade B-cell lymphoma, or HGBL. We reported preliminary clinical data from this combination study in December 2019. In March 2020, we announced that although we observed no significant drug-drug interaction in our Phase 1 study of fimepinostat in combination with venetoclax, we did not see an efficacy signal that would warrant continuation of the study. Accordingly, no further patients will be enrolled in this study. We are currently evaluating future studies for fimepinostat.
|
•
|
Our pipeline includes CA-170 for which we announced initial data from a clinical study in patients with mesothelioma in conjunction with the Society of lmmunotherapy of Cancer conference in November 2019. Based on this data, no further patients will be enrolled in the study. We are currently evaluating future studies for CA-170.
|
1.
|
IRAK4 Program - a precision oncology program of small molecule inhibitors of IRAK4. The development candidate is CA-4948, an orally available small molecule inhibitor of IRAK4.
|
2.
|
PD1/VISTA Program - an immuno-oncology program of small molecule antagonists of PD1 and VISTA immune checkpoint pathways. The development candidate is CA-170, an orally available small molecule antagonist of VISTA and PDL1.
|
3.
|
PD1/TIM3 Program - an immuno-oncology program of small molecule antagonists of PD1 and TIM3 immune checkpoint pathways. The development candidate is CA-327, an orally available small molecule antagonist of PDL1 and TIM3.
|
4.
|
In March 2018, we exercised our option to license a fourth program, which is an immuno-oncology program.
|
1.
|
IRAK4 Program - a precision oncology program of small molecule inhibitors of IRAK4. The development candidate is CA-4948, an orally available small molecule inhibitor of IRAK4.
|
2.
|
PD1/VISTA Program - an immuno-oncology program of small molecule antagonists of PD1 and VISTA immune checkpoint pathways. The development candidate is CA-170, an orally available small molecule antagonist of VISTA and PDL1.
|
3.
|
PD1/TIM3 Program - an immuno-oncology program of small molecule antagonists of PD1 and TIM3 immune checkpoint pathways. The development candidate is CA-327, an orally available small molecule antagonist of PDL1 and TIM3.
|
4.
|
In March 2018, we exercised our option to license a fourth program, which is an immuno-oncology program.
|
•
|
with respect to amounts that we and our affiliates receive from sublicensees under a licensed program in the U.S. or the European Union, a declining percentage of non-royalty sublicense revenues that is dependent on the stage of the most advanced product for such licensed program at the time the sublicense is granted, including, for example 25% of such amounts following our initiation of a Phase 2 clinical study and 15% of such amounts after initiation of the first pivotal study. This sharing will also extend to royalties that we receive from sublicensees, subject to minimum royalty percentage rates that we are obligated to pay to Aurigene, which generally range from mid-to-high single-digit royalty percentage rates up to 10%;
|
•
|
with respect to sublicensing revenues we and our affiliates receive from sublicensees under a licensed program in Asia, 50% of such sublicensing revenues, including both non-royalty sublicensee revenues and royalties that we receive from sublicensees; and
|
•
|
with respect to non-royalty sublicensing revenues we and our affiliates receive from sublicensees under a licensed program outside of the U.S., the European Union and Asia, a percentage of such non-royalty sublicense revenues ranging from 30% to 50%. We are also obligated to share 50% of royalties that we receive from sublicensees that we receive in these territories.
|
•
|
our ability to successfully plan, finance and complete current and planned clinical trials for CA-4948, CI-8993, and fimepinostat as well as for such clinical trials to generate favorable data;
|
•
|
Aurigene’s ability to advance additional preclinical immuno-oncology, and precision oncology drug candidates, and our ability to license these programs from Aurigene and further progress them clinically; and
|
•
|
our ability to raise the substantial additional financing required to fund our operations through our common stock purchase agreement with Aspire Capital and our at-the-market sales agreement with JonesTrading Institutional Services LLC, or JonesTrading or other potential financing.
|
•
|
costs of conducting clinical trials, including amounts paid to clinical centers, clinical research organizations and consultants, among others;
|
•
|
certain payments that we make to Aurigene under our collaboration agreement, including, for example, option exercise fees and milestone payments; and
|
•
|
payments that we are obligated to make to certain third-party university licensors upon our receipt of payments from Genentech related to the achievement of clinical development and regulatory objectives under our collaboration agreement.
|
•
|
the scope, quality of data, rate of progress and cost of clinical trials and other research and development activities undertaken by us or our collaborators;
|
•
|
the results of future preclinical studies and clinical trials;
|
•
|
the cost and timing of regulatory approvals and maintaining compliance with regulatory requirements;
|
•
|
the cost and timing of establishing sales, marketing and distribution capabilities;
|
•
|
the cost of establishing clinical and commercial supplies of our drug candidates and any products that we may develop;
|
•
|
the effect of competing technological and market developments; and
|
•
|
the cost and effectiveness of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights.
|
|
For the Year Ended
December 31,
|
|
Percentage Increase/ (Decrease)
|
|||||||
|
2019
|
|
2018
|
|
2019 v. 2018
|
|||||
Revenues
|
$
|
10,004
|
|
|
$
|
10,428
|
|
|
(4
|
)%
|
Cost of royalty revenues
|
503
|
|
|
563
|
|
|
(11
|
)%
|
||
Research and development
|
22,302
|
|
|
24,413
|
|
|
(9
|
)%
|
||
General and administrative
|
11,555
|
|
|
14,785
|
|
|
(22
|
)%
|
||
Total other expense, net
|
7,785
|
|
|
3,242
|
|
|
>100%
|
|
||
Net loss
|
$
|
(32,141
|
)
|
|
$
|
(32,575
|
)
|
|
1
|
%
|
|
For the Year Ended
December 31,
|
|
Percentage Increase/ (Decrease)
|
|||||||
|
2019
|
|
2018
|
|
2019 v. 2018
|
|||||
Royalties
|
$
|
10,418
|
|
|
$
|
10,421
|
|
|
—
|
%
|
Contra revenue, net
|
(414
|
)
|
|
7
|
|
|
<(100%)
|
|
||
Total revenues
|
$
|
10,004
|
|
|
$
|
10,428
|
|
|
(4
|
)%
|
|
For the Year Ended
December 31,
|
|
Percentage Increase/ (Decrease)
|
|||||||
|
2019
|
|
2018
|
|
2019 v. 2018
|
|||||
Direct research and development expenses
|
$
|
14,719
|
|
|
$
|
10,941
|
|
|
35
|
%
|
Employee-related expenses
|
5,921
|
|
|
11,378
|
|
|
(48
|
)%
|
||
Facilities, depreciation and other expenses
|
1,662
|
|
|
2,094
|
|
|
(21
|
)%
|
||
Total research and development expenses
|
$
|
22,302
|
|
|
$
|
24,413
|
|
|
(9
|
)%
|
|
For the Year Ended
December 31,
|
|
Percentage Increase/ (Decrease)
|
|||||||
|
2019
|
|
2018
|
|
2019 v. 2018
|
|||||
Personnel
|
$
|
3,705
|
|
|
$
|
5,277
|
|
|
(30
|
)%
|
Occupancy and depreciation
|
580
|
|
|
553
|
|
|
5
|
%
|
||
Legal services
|
2,020
|
|
|
2,906
|
|
|
(30
|
)%
|
||
Professional and consulting services
|
1,842
|
|
|
2,142
|
|
|
(14
|
)%
|
||
Insurance costs
|
453
|
|
|
409
|
|
|
11
|
%
|
||
Stock-based compensation
|
2,083
|
|
|
2,630
|
|
|
(21
|
)%
|
||
Other general and administrative expenses
|
872
|
|
|
868
|
|
|
—
|
%
|
||
Total general and administrative expenses
|
$
|
11,555
|
|
|
$
|
14,785
|
|
|
(22
|
)%
|
•
|
unanticipated costs in our research and development programs;
|
•
|
the timing and cost of obtaining regulatory approvals for our drug candidates and maintaining compliance with regulatory requirements;
|
•
|
the timing and amount of option exercise fees, milestone payments, royalties and other payments, including payments due to licensors, including Aurigene, for patent rights and technology used in our drug development programs;
|
•
|
the costs of commercialization activities for any of our drug candidates that receive marketing approval, to the extent such costs are our responsibility, including the costs and timing of establishing drug sales, marketing, distribution and manufacturing capabilities;
|
•
|
unplanned costs to prepare, file, prosecute, defend and enforce patent claims and other patent-related costs, including litigation costs and technology license fees; and
|
•
|
unexpected losses in our cash investments or an inability to otherwise liquidate our cash investments due to unfavorable conditions in the capital markets.
|
•
|
our ability to continue as a going concern.
|
|
Payment Due By Period (amounts in 000’s)
|
||||||||||||||||||
|
Total
|
|
Less than
One Year
|
|
One to
Three Years
|
|
Three to
Five Years
|
|
More than
Five Years
|
||||||||||
Operating lease obligations (1)
|
$
|
8,509
|
|
|
$
|
984
|
|
|
$
|
2,260
|
|
|
$
|
2,397
|
|
|
$
|
2,868
|
|
Outside service obligations (2)
|
779
|
|
|
434
|
|
|
345
|
|
|
—
|
|
|
—
|
|
|||||
Licensing obligations (3)
|
382
|
|
|
307
|
|
|
75
|
|
|
—
|
|
|
—
|
|
|||||
Total future obligations
|
$
|
9,670
|
|
|
$
|
1,725
|
|
|
$
|
2,680
|
|
|
$
|
2,397
|
|
|
$
|
2,868
|
|
(1)
|
We lease 24,529 square feet of property for office, research and laboratory space located at 4 Maguire Road in Lexington, Massachusetts. The term of the lease agreement commenced on December 1, 2010 and, pursuant to a second amendment to the lease agreement on November 1, 2017, expired on February 29, 2020. We are exercising our contractual right to holdover until our new facility is available for occupancy. The total remaining cash obligation for the base rent over the second amended term of the lease agreement was approximately $0.2 million at December 31, 2019. In addition to the base rent, we are responsible for our share of operating expenses and real estate taxes, in accordance with the terms of the lease agreement. Amounts include contractual rent payments as defined in the agreement. On December 5, 2019, we entered into a new lease for our administrative, research and development requirements located at 128 Spring Street in Lexington, Massachusetts consisting of 21,772 square feet. The lease will expire in seven years from the commencement date of the lease which we expect to occur in the second quarter of 2020. In addition to the base rent, we are responsible for our share of operating expenses and real estate taxes, in accordance with the terms of the lease agreement. Amounts include contractual rent payments as defined in the agreement.
|
(2)
|
Outside service obligations consist of agreements we have with outside labs, consultants and various other service organizations. Obligations to clinical research organizations, medical centers and hospitals conducting our clinical trials are included in our financial statements for costs incurred as of December 31, 2019. Our obligations under these types of arrangements are limited to actual costs incurred for services performed and do not include any contingent or milestone payments.
|
(3)
|
Licensing obligations include only obligations that are known to us as of December 31, 2019. In the future, we may owe royalties and other contingent payments to our licensors based on the achievement of developmental milestones,
|
ITEM 7A.
|
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
|
ITEM 8.
|
FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
|
•
|
pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of our assets;
|
•
|
provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorizations of management and our board of directors; and
|
•
|
provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the financial statements.
|
/s/ PricewaterhouseCoopers LLP
|
Boston, Massachusetts
|
March 19, 2020
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
ASSETS
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
15,430
|
|
|
$
|
23,636
|
|
Restricted cash
|
153
|
|
|
—
|
|
||
Investments
|
5,113
|
|
|
634
|
|
||
Accounts receivable
|
3,244
|
|
|
2,864
|
|
||
Prepaid expenses and other current assets
|
1,063
|
|
|
827
|
|
||
Total current assets
|
25,003
|
|
|
27,961
|
|
||
Property and equipment, net
|
154
|
|
|
267
|
|
||
Restricted cash
|
816
|
|
|
153
|
|
||
Operating lease right-of-use asset
|
149
|
|
|
—
|
|
||
Goodwill
|
8,982
|
|
|
8,982
|
|
||
Other assets
|
3
|
|
|
2
|
|
||
Total assets
|
$
|
35,107
|
|
|
$
|
37,365
|
|
LIABILITIES AND STOCKHOLDERS’ DEFICIT
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
4,465
|
|
|
$
|
2,909
|
|
Accrued liabilities
|
1,910
|
|
|
3,457
|
|
||
Operating lease liability
|
166
|
|
|
—
|
|
||
Current portion of long-term debt, net
|
—
|
|
|
6,884
|
|
||
Total current liabilities
|
6,541
|
|
|
13,250
|
|
||
Long-term debt, net
|
—
|
|
|
28,600
|
|
||
Liability related to the sale of future royalties, net
|
62,477
|
|
|
—
|
|
||
Other long-term liabilities
|
—
|
|
|
11
|
|
||
Total liabilities
|
69,018
|
|
|
41,861
|
|
||
Stockholders’ deficit:
|
|
|
|
||||
Common stock, $0.01 par value—101,250,000 shares authorized, 33,241,793 shares issued and outstanding at December 31, 2019; 67,500,000 shares authorized, 33,159,253 shares issued and outstanding at December 31, 2018
|
332
|
|
|
332
|
|
||
Additional paid-in capital
|
982,738
|
|
|
980,012
|
|
||
Accumulated deficit
|
(1,016,981
|
)
|
|
(984,840
|
)
|
||
Total stockholders’ deficit
|
(33,911
|
)
|
|
(4,496
|
)
|
||
Total liabilities and stockholders’ deficit
|
$
|
35,107
|
|
|
$
|
37,365
|
|
|
Years Ended December 31,
|
||||||
|
2019
|
|
2018
|
||||
Revenues, net:
|
|
|
|
||||
Royalties
|
$
|
10,418
|
|
|
$
|
10,421
|
|
Contra revenue, net
|
(414
|
)
|
|
7
|
|
||
Total revenues, net
|
10,004
|
|
|
10,428
|
|
||
Costs and expenses:
|
|
|
|
||||
Cost of royalties
|
503
|
|
|
563
|
|
||
Research and development
|
22,302
|
|
|
24,413
|
|
||
General and administrative
|
11,555
|
|
|
14,785
|
|
||
Total costs and expenses
|
34,360
|
|
|
39,761
|
|
||
Loss from operations
|
(24,356
|
)
|
|
(29,333
|
)
|
||
Other expense:
|
|
|
|
||||
Loss on debt extinguishment
|
(3,495
|
)
|
|
—
|
|
||
Interest income
|
614
|
|
|
684
|
|
||
Imputed interest expense related to the sale of future royalties
|
(4,055
|
)
|
|
—
|
|
||
Interest expense, debt
|
(791
|
)
|
|
(3,926
|
)
|
||
Other income (expense), net
|
(58
|
)
|
|
—
|
|
||
Total other expense
|
(7,785
|
)
|
|
(3,242
|
)
|
||
Net loss
|
$
|
(32,141
|
)
|
|
$
|
(32,575
|
)
|
Net loss per common share (basic and diluted)
|
$
|
(0.97
|
)
|
|
$
|
(0.98
|
)
|
Weighted average common shares (basic and diluted)
|
33,180,516
|
|
|
33,118,393
|
|
||
Net loss
|
$
|
(32,141
|
)
|
|
$
|
(32,575
|
)
|
Other comprehensive gain
|
|
|
|
||||
Unrealized gain on marketable securities
|
—
|
|
|
2
|
|
||
Comprehensive loss
|
$
|
(32,141
|
)
|
|
$
|
(32,573
|
)
|
|
Common Stock
|
|
Additional
Paid-in
Capital
|
|
Treasury
Stock
|
|
Accumulated
Deficit
|
|
Accumulated
Other
Comprehensive
Income/(Loss)
|
|
Total
Stockholders’
Equity
|
|||||||||||||||
|
Shares
|
|
Amount
|
|
||||||||||||||||||||||
Balance, December 31, 2017
|
33,075,949
|
|
|
$
|
331
|
|
|
$
|
977,453
|
|
|
$
|
(1,524
|
)
|
|
$
|
(952,265
|
)
|
|
$
|
(2
|
)
|
|
$
|
23,993
|
|
Issuance of common stock under grant of restricted stock awards
|
294,250
|
|
|
3
|
|
|
(3
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Issuances of common stock upon the exercise of stock options and for purchases under the ESPP
|
101,623
|
|
|
1
|
|
|
142
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
143
|
|
||||||
Recognition of stock-based compensation
|
—
|
|
|
—
|
|
|
3,941
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
3,941
|
|
||||||
Cancellation of restricted stock awards
|
(68,000
|
)
|
|
(1
|
)
|
|
1
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Retirement of treasury stock
|
(244,569
|
)
|
|
(2
|
)
|
|
(1,522
|
)
|
|
1,524
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Other comprehensive income
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2
|
|
|
2
|
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(32,575
|
)
|
|
—
|
|
|
(32,575
|
)
|
||||||
December 31, 2018
|
33,159,253
|
|
|
332
|
|
|
980,012
|
|
|
—
|
|
|
(984,840
|
)
|
|
—
|
|
|
(4,496
|
)
|
||||||
Issuances of common stock upon the exercise of stock options and for purchases under the ESPP
|
91,013
|
|
|
—
|
|
|
68
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
68
|
|
||||||
Recognition of stock-based compensation
|
—
|
|
|
—
|
|
|
2,658
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,658
|
|
||||||
Cancellation of restricted stock awards
|
(8,473
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Net Loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(32,141
|
)
|
|
—
|
|
|
(32,141
|
)
|
||||||
Balance, December 31, 2019
|
33,241,793
|
|
|
$
|
332
|
|
|
$
|
982,738
|
|
|
$
|
—
|
|
|
$
|
(1,016,981
|
)
|
|
$
|
—
|
|
|
$
|
(33,911
|
)
|
|
Years Ended December 31,
|
||||||
|
2019
|
|
2018
|
||||
Cash flows from operating activities:
|
|
|
|
||||
Net loss
|
$
|
(32,141
|
)
|
|
$
|
(32,575
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
||||
Depreciation and amortization
|
125
|
|
|
177
|
|
||
Non-cash lease expense
|
956
|
|
|
—
|
|
||
Stock-based compensation expense
|
2,658
|
|
|
3,940
|
|
||
Amortization of debt issuance costs
|
8
|
|
|
35
|
|
||
Non-cash imputed interest expense related to the sale of future royalties
|
287
|
|
|
—
|
|
||
Non-cash interest income on investments
|
(64
|
)
|
|
(147
|
)
|
||
Loss on extinguishment of debt
|
3,495
|
|
|
—
|
|
||
Loss on disposal of fixed assets
|
29
|
|
|
7
|
|
||
Changes in operating assets and liabilities:
|
|
|
|
||||
Accounts receivable
|
(380
|
)
|
|
209
|
|
||
Prepaid expenses and other assets
|
(237
|
)
|
|
162
|
|
||
Accounts payable and accrued and other liabilities
|
60
|
|
|
(1,873
|
)
|
||
Operating lease liability
|
(1,001
|
)
|
|
—
|
|
||
Total adjustments
|
5,936
|
|
|
2,510
|
|
||
Net cash used in operating activities
|
(26,205
|
)
|
|
(30,065
|
)
|
||
Cash flows from investing activities:
|
|
|
|
||||
Purchases of investments
|
(11,465
|
)
|
|
(26,741
|
)
|
||
Sales and maturities of investments
|
7,050
|
|
|
48,200
|
|
||
Purchases of property and equipment
|
(41
|
)
|
|
(85
|
)
|
||
Net cash (used in) provided by investing activities
|
(4,456
|
)
|
|
21,374
|
|
||
Cash flows from financing activities:
|
|
|
|
||||
Proceeds from royalty interest purchase agreement with Oberland Capital Management, LLC
|
65,000
|
|
|
—
|
|
||
Payment of transaction costs on royalty interest purchase agreement
|
(584
|
)
|
|
—
|
|
||
Proceeds from issuance of common stock under the Company’s stock-based compensation plans
|
68
|
|
|
143
|
|
||
Payment of liability of future royalties, net of imputed interest
|
(2,226
|
)
|
|
—
|
|
||
Payment on termination of credit agreement with HealthCare Royalty Partners, III, L.P.
|
(37,162
|
)
|
|
—
|
|
||
Payments made on Curis Royalty’s debt
|
(1,825
|
)
|
|
(6,104
|
)
|
||
Net cash provided by (used in) financing activities
|
23,271
|
|
|
(5,961
|
)
|
||
Net (decrease) increase in cash and cash equivalents and restricted cash
|
(7,390
|
)
|
|
(14,652
|
)
|
||
Cash and cash equivalents and restricted cash, beginning of period
|
23,789
|
|
|
38,441
|
|
||
Cash and cash equivalents and restricted cash, end of period
|
$
|
16,399
|
|
|
$
|
23,789
|
|
Supplemental cash flow data:
|
|
|
|
||||
Cash paid for interest
|
$
|
4,716
|
|
|
$
|
3,919
|
|
(1)
|
Nature of Business
|
•
|
CA-4948, which is being tested in a dose escalating clinical trial in patients with non-Hodgkin lymphomas, including those with myeloid differentiation primary response 88, or MYD88, alterations. The Company reported preliminary clinical data from the study in the fourth quarter of 2019. The Company is currently planning to initiate a separate Phase 1 trial for acute myeloid leukemia and myelodysplastic syndromes patients in the first half of 2020.
|
•
|
CI-8993, a monoclonal antibody designed to antagonize the V-domain Ig suppressor of T cell activation (“VISTA”) signaling pathway, which the Company plans to begin clinical testing in a Phase 1a/1b trial in 2020.
|
•
|
Fimepinostat, which is currently being explored in clinical studies in patients with MYC-altered diffuse large B-cell lymphoma (DLBCL) and solid tumors and has been granted Orphan Drug Designation and Fast Track Designation for the treatment of DLBCL by the U.S. Food and Drug Administration (“FDA”) in April 2015 and May 2018, respectively. The Company has begun enrollment in a Phase 1 combination study with venetoclax in DLBCL patients, including patients with translocations in both MYC and the BCL2 gene, also referred to as double-hit lymphoma, or high-grade B-cell lymphoma (“HGBL”). The Company reported preliminary clinical data from this combination study in the fourth quarter of 2019. In March 2020, the Company announced that although it observed no significant drug-drug interaction in its Phase 1 study of fimepinostat in combination with venetoclax, the Company did not see an efficacy signal that would warrant continuation of the study. Accordingly, no further patients will be enrolled in this study. The Company is currently evaluating future studies for fimepinostat.
|
•
|
The Company's pipeline includes CA-170, for which the Company announced initial data from a clinical study in patients with mesothelioma, in conjunction with the Society of lmmunotherapy of Cancer conference in November 2019. Based on this data, no further patients will be enrolled in the study. The Company is currently evaluating future studies for CA-170.
|
(2)
|
Summary of Significant Accounting Policies
|
(a)
|
Basis of Presentation and Principals of Consolidation
|
(b)
|
Use of Estimates and Assumptions
|
(c)
|
Cash Equivalents, Restricted Cash, and Investments
|
(d)
|
Concentrations and Significant Customer Information
|
(e)
|
Long-Lived Assets Other than Goodwill
|
|
Useful Life
|
Laboratory equipment, computers and software
|
3-5 years
|
Leasehold improvements
|
Lesser of lease or asset life
|
Office furniture and equipment
|
5 years
|
(f)
|
Leases
|
(g)
|
Goodwill
|
(h)
|
Revenue Recognition
|
(i)
|
Research and Development
|
(j)
|
Basic and Diluted Loss per Common Share
|
|
For the Year Ended December 31,
|
||||
|
2019
|
|
2018
|
||
Stock options outstanding
|
6,158,026
|
|
|
3,714,394
|
|
Total antidilutive securities
|
6,158,026
|
|
|
3,714,394
|
|
(k)
|
Stock-Based Compensation
|
(l)
|
Comprehensive Loss
|
(m)
|
Segment Reporting
|
(n)
|
Interest Expense on Liability related to the Sale of Future Royalties
|
(o)
|
New Accounting Pronouncements
|
(3)
|
Fair Value of Financial Instruments
|
Level 1
|
Quoted prices in active markets for identical assets or liabilities.
|
|
|
Level 2
|
Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
|
|
|
Level 3
|
Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
|
|
Quoted Prices in
Active Markets
(Level 1)
|
|
Other
Observable
Inputs
(Level 2)
|
|
Unobservable
Inputs
(Level 3)
|
|
Fair Value
|
||||||||
|
(in thousands)
|
||||||||||||||
As of December 31, 2019
|
|
|
|
|
|
|
|
||||||||
Cash equivalents:
|
|
|
|
|
|
|
|
||||||||
Money market funds
|
$
|
10,684
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
10,684
|
|
US government obligations
|
—
|
|
|
550
|
|
|
—
|
|
|
550
|
|
||||
Commercial paper
|
—
|
|
|
300
|
|
|
—
|
|
|
300
|
|
||||
Municipal bonds
|
—
|
|
|
90
|
|
|
—
|
|
|
90
|
|
||||
Short-term investments:
|
|
|
|
|
|
|
|
||||||||
Corporate commercial paper, bonds and notes
|
—
|
|
|
5,113
|
|
|
—
|
|
|
5,113
|
|
||||
Total assets at fair value
|
$
|
10,684
|
|
|
$
|
6,053
|
|
|
$
|
—
|
|
|
$
|
16,737
|
|
|
Quoted Prices in
Active Markets
(Level 1)
|
|
Other
Observable
Inputs
(Level 2)
|
|
Unobservable
Inputs
(Level 3)
|
|
Fair Value
|
||||||||
|
(in thousands)
|
||||||||||||||
As of December 31, 2018
|
|
|
|
|
|
|
|
||||||||
Cash equivalents:
|
|
|
|
|
|
|
|
||||||||
Money market funds
|
$
|
18,180
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
18,180
|
|
Corporate commercial paper, stock, bonds and notes
|
—
|
|
|
2,199
|
|
|
—
|
|
|
2,199
|
|
||||
Municipal bonds
|
—
|
|
|
135
|
|
|
—
|
|
|
135
|
|
||||
Short-term investments:
|
|
|
|
|
|
|
|
||||||||
Corporate commercial paper, stock, bonds and notes
|
—
|
|
|
634
|
|
|
—
|
|
|
634
|
|
||||
Total assets at fair value
|
$
|
18,180
|
|
|
$
|
2,968
|
|
|
$
|
—
|
|
|
$
|
21,148
|
|
(4)
|
Investments
|
|
Amortized
Cost
|
|
Unrealized
Gain
|
|
Unrealized
Loss
|
|
Fair Value
|
||||||||
Corporate bonds and notes—short-term
|
$
|
5,113
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
5,113
|
|
Total investments
|
$
|
5,113
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
5,113
|
|
|
Amortized
Cost
|
|
Unrealized
Gain
|
|
Unrealized
Loss
|
|
Fair Value
|
||||||||
Corporate bonds and notes—short-term
|
$
|
634
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
634
|
|
Total investments
|
$
|
634
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
634
|
|
(5)
|
Property and Equipment, Net
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
Laboratory equipment, computers and software
|
$
|
1,725
|
|
|
$
|
1,753
|
|
Leasehold improvements
|
185
|
|
|
185
|
|
||
Office furniture and equipment
|
331
|
|
|
354
|
|
||
|
2,241
|
|
|
2,292
|
|
||
Less—Accumulated depreciation and amortization
|
(2,087
|
)
|
|
(2,025
|
)
|
||
Total
|
$
|
154
|
|
|
$
|
267
|
|
(6)
|
Accrued Liabilities
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
Accrued compensation
|
$
|
1,413
|
|
|
$
|
2,774
|
|
Professional fees
|
289
|
|
|
233
|
|
||
Accrued interest on debt (see Note 11)
|
—
|
|
|
165
|
|
||
Other
|
208
|
|
|
285
|
|
||
Total
|
$
|
1,910
|
|
|
$
|
3,457
|
|
(7)
|
Leases and Commitments
|
(a)
|
Operating Leases
|
Balance sheet location
|
|
As of December 31, 2019
|
||
Assets:
|
|
|
||
Operating lease right-of-use asset
|
|
$
|
149
|
|
|
|
|
||
Liabilities:
|
|
|
||
Operating lease liability
|
|
$
|
166
|
|
Income statement location
|
|
For the year ended
December 31,
2019
|
||
Operating lease cost
|
|
|
||
Research and development
|
|
$
|
651
|
|
General and administrative
|
|
351
|
|
|
Total lease cost
|
|
$
|
1,002
|
|
Year Ending December 31,
|
|
|
||
2020
|
|
$
|
168
|
|
2021
|
|
—
|
|
|
2022
|
|
—
|
|
|
2023
|
|
—
|
|
|
2024
|
|
—
|
|
|
Thereafter
|
|
—
|
|
|
Total lease payments
|
|
$
|
168
|
|
Less: interest
|
|
2
|
|
|
Present value of operating lease liabilities
|
|
$
|
166
|
|
Year Ending December 31,
|
|
|
||
2019
|
|
$
|
1,002
|
|
2020
|
|
168
|
|
|
Total minimum payments
|
|
$
|
1,170
|
|
(b)
|
License Agreements
|
(8)
|
Liability Related to the Sale of Future Royalties
|
Liability related to sale of future royalties at March 22, 2019
|
$
|
65,000
|
|
Issuance costs capitalized
|
(584
|
)
|
|
Imputed interest expense recognized
|
4,055
|
|
|
Less: Payments made to Oberland Capital, LLC
|
(5,994
|
)
|
|
Carrying value of liability related to sale of future royalties at December 31, 2019
|
$
|
62,477
|
|
(9)
|
Income Taxes
|
|
For the Year Ended
December 31,
|
||||
|
2019
|
|
2018
|
||
Statutory federal income tax rate
|
21.0
|
%
|
|
21.0
|
%
|
State income taxes, net of federal benefit
|
6.1
|
%
|
|
5.9
|
%
|
Research and development tax credits
|
2.7
|
%
|
|
3.8
|
%
|
Orphan drug tax credits
|
4.6
|
%
|
|
3.2
|
%
|
Expiration of NOLs/Credits
|
(4.0
|
)%
|
|
(13.5
|
)%
|
Permanent adjustments and other
|
(0.6
|
)%
|
|
(1.1
|
)%
|
Change in valuation allowance
|
(29.8
|
)%
|
|
(19.3
|
)%
|
Effective income tax rate
|
—
|
%
|
|
—
|
%
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
Deferred Tax Assets:
|
|
|
|
||||
NOL carryforwards
|
$
|
58,654
|
|
|
$
|
67,068
|
|
Research and development tax credit carryforwards
|
15,408
|
|
|
15,825
|
|
||
Orphan drug tax credit carryforwards
|
18,088
|
|
|
16,625
|
|
||
Depreciation and amortization
|
9,671
|
|
|
10,672
|
|
||
Capitalized research and development expenditures
|
34,487
|
|
|
33,993
|
|
||
Stock options
|
6,329
|
|
|
5,783
|
|
||
Accrued expenses and other
|
131
|
|
|
259
|
|
||
Oberland agreement
|
17,022
|
|
|
—
|
|
||
Lease liability ASC 842
|
45
|
|
|
—
|
|
||
Total gross deferred tax asset
|
159,835
|
|
|
150,225
|
|
||
Valuation allowance
|
(159,794
|
)
|
|
(150,225
|
)
|
||
Net deferred tax asset
|
$
|
41
|
|
|
$
|
—
|
|
|
|
|
|
||||
Deferred tax liabilities:
|
|
|
|
||||
Right of use asset ASC 842
|
(41
|
)
|
|
—
|
|
||
Total gross deferred tax liabilities
|
$
|
(41
|
)
|
|
$
|
—
|
|
|
|
|
|
||||
Net deferred tax assets (liabilities)
|
$
|
—
|
|
|
$
|
—
|
|
(10)
|
Research and Development Collaborations
|
(a)
|
Genentech
|
(b)
|
Aurigene
|
1.
|
IRAK4 Program - a precision oncology program of small molecule inhibitors of IRAK4. The development candidate is CA-4948, an orally available small molecule inhibitor of IRAK4.
|
2.
|
PD1/VISTA Program - an immuno-oncology program of small molecule antagonists of PD1 and VISTA immune checkpoint pathways. The development candidate is CA-170, an orally available small molecule antagonist of VISTA and PDL1.
|
3.
|
PD1/TIM3 Program - an immuno-oncology program of small molecule antagonists of PD1 and TIM3 immune checkpoint pathways. The development candidate is CA-327, an orally available small molecule antagonist of PDL1 and TIM3.
|
4.
|
In March 2018, the Company exercised its option to license a fourth program, which is an immuno-oncology program.
|
(c)
|
ImmuNext
|
(11)
|
Debt
|
(a)
|
HealthCare Royalty Partners III
|
(b)
|
Debt Payments to HealthCare Royalty Partners III
|
|
As of
December 31,
|
||
|
2018
|
||
Debt, current
|
$
|
6,920
|
|
Debt issue costs, current
|
(36
|
)
|
|
Debt, current portion net of issuance costs
|
$
|
6,884
|
|
Debt, long-term
|
28,696
|
|
|
Debt issue costs, long-term
|
(96
|
)
|
|
Debt, net of current portion and issuance costs
|
$
|
28,600
|
|
(12)
|
Common Stock
|
(a)
|
Reverse Stock Split
|
(b)
|
Treasury Stock Retirement
|
(c)
|
2015 Sales Agreement with Cowen
|
(d)
|
2018 Charter Amendment
|
(e)
|
2019 Charter Amendment
|
(13)
|
Stock Plans and Stock-Based Compensation
|
|
For the Year Ended
December 31,
|
||||
|
2019
|
|
2018
|
||
Expected term (years)—Employees and Officers
|
5.5
|
|
|
5.5
|
|
Expected term (years)—Directors
|
5.5
|
|
|
N/A
|
|
Risk-free interest rate
|
1.5-2.6%
|
|
|
2.5-3.0%
|
|
Expected volatility
|
76-79%
|
|
|
66-73%
|
|
Expected dividend yield
|
None
|
|
|
None
|
|
|
Number of
Options
|
|
Weighted
Average
Exercise
Price per
Share
|
|
Weighted
Average
Remaining Contractual Life
|
|
Aggregate Intrinsic Value
|
|||||
Outstanding, December 31, 2018
|
3,714,394
|
|
|
$
|
7.68
|
|
|
6.38
|
|
|
||
Granted
|
4,033,365
|
|
|
1.30
|
|
|
|
|
|
|||
Exercised
|
—
|
|
|
—
|
|
|
|
|
|
|||
Canceled
|
(1,589,733
|
)
|
|
7.97
|
|
|
|
|
|
|||
Outstanding, December 31, 2019
|
6,158,026
|
|
|
$
|
3.43
|
|
|
8.33
|
|
$
|
1,657
|
|
Exercisable at December 31, 2019
|
1,561,926
|
|
|
$
|
8.44
|
|
|
6.47
|
|
$
|
26
|
|
Vested and unvested expected to vest
|
5,540,023
|
|
|
$
|
3.64
|
|
|
8.25
|
|
$
|
1,451
|
|
|
Number of
Shares
|
|
Weighted
Average
Grant Date Fair Value
|
||
Unvested, December 31, 2018
|
226,250
|
|
|
3.45
|
|
Awarded
|
—
|
|
|
—
|
|
Vested
|
(195,313
|
)
|
|
3.45
|
|
Forfeited
|
—
|
|
|
—
|
|
Unvested, December 31, 2019
|
30,937
|
|
|
3.45
|
|
|
For the Year Ended December 31,
|
||||||
|
2019
|
|
2018
|
||||
Compensation expense recognized under ESPP
|
$
|
49
|
|
|
$
|
173
|
|
Expected term
|
6-24 months
|
|
|
6-24 months
|
|
||
Risk-free interest rate
|
1.5-2.1%
|
|
|
2.1-2.7%
|
|
||
Volatility
|
92-97%
|
|
|
79-104%
|
|
||
Dividends
|
None
|
|
|
None
|
|
|
For the Year Ended December 31,
|
||||||
|
2019
|
|
2018
|
||||
Research and development expenses
|
$
|
575
|
|
|
$
|
1,310
|
|
General and administrative expenses
|
2,083
|
|
|
2,630
|
|
||
Total stock-based compensation expense
|
$
|
2,658
|
|
|
$
|
3,940
|
|
(14)
|
Related Party Transactions
|
(a)
|
Agreement with Head of Research and Development - Robert E. Martell, M.D., Ph.D.
|
(b)
|
Agreement with David Tuck
|
(15)
|
Retirement Savings Plan
|
(16)
|
Selected Quarterly Financial Data (Unaudited)
|
|
Quarter Ended
|
||||||||||||||
|
March 31,
2019 |
|
June 30,
2019 |
|
September 30,
2019 |
|
December 31, 2019
|
||||||||
Revenues
|
$
|
1,767
|
|
|
$
|
2,094
|
|
|
$
|
2,856
|
|
|
$
|
3,287
|
|
Loss from operations
|
(5,558
|
)
|
|
(6,141
|
)
|
|
(5,323
|
)
|
|
(7,334
|
)
|
||||
Net loss
|
(9,884
|
)
|
|
(7,213
|
)
|
|
(6,436
|
)
|
|
(8,609
|
)
|
||||
Net loss per common share (basic and diluted)
|
$
|
(0.30
|
)
|
|
$
|
(0.22
|
)
|
|
$
|
(0.19
|
)
|
|
$
|
(0.26
|
)
|
Weighted average common shares (basic and diluted)
|
33,150,869
|
|
|
33,154,566
|
|
|
33,202,871
|
|
|
33,209,217
|
|
|
Quarter Ended
|
||||||||||||||
|
March 31,
2018 |
|
June 30,
2018 |
|
September 30,
2018 |
|
December 31, 2018
|
||||||||
Revenues
|
$
|
2,468
|
|
|
$
|
2,358
|
|
|
$
|
2,847
|
|
|
$
|
2,755
|
|
Loss from operations
|
(9,908
|
)
|
|
(7,860
|
)
|
|
(6,417
|
)
|
|
(5,148
|
)
|
||||
Net loss
|
(10,747
|
)
|
|
(8,664
|
)
|
|
(7,223
|
)
|
|
(5,941
|
)
|
||||
Net loss per common share (basic and diluted)
|
$
|
(0.33
|
)
|
|
$
|
(0.26
|
)
|
|
$
|
(0.22
|
)
|
|
$
|
(0.18
|
)
|
Weighted average common shares (basic and diluted)
|
33,053,702
|
|
|
33,135,391
|
|
|
33,161,592
|
|
|
33,121,666
|
|
(17)
|
Subsequent Events
|
ITEM 9.
|
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
|
ITEM 9A.
|
CONTROLS AND PROCEDURES
|
ITEM 9B.
|
OTHER INFORMATION
|
ITEM 10.
|
DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
|
ITEM 11.
|
EXECUTIVE COMPENSATION
|
ITEM 12.
|
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
|
ITEM 13.
|
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
|
ITEM 14.
|
PRINCIPAL ACCOUNTANT FEES AND SERVICES
|
ITEM 15.
|
EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
|
|
Page number
in this report
|
Curis, Inc. and Subsidiaries
|
|
|
|
|
|
|
|
Incorporated by Reference
|
||||||
Exhibit
No.
|
|
Description
|
|
Link to Filing
|
|
Form
|
|
SEC Filing
Date
|
|
Exhibit
Number
|
|
Filed with
this 10-K
|
|
|
Articles of Incorporation and By-laws
|
|
|
|
|
|
|
|
|
|
|
3.1
|
|
Restated Certificate of Incorporation of Curis, Inc., as amended
|
|
|
10-Q
|
|
8/9/2019
|
|
3.1
|
|
|
|
3.2
|
|
Certificate of Designations of Curis, Inc.
|
|
|
S-3 (333-50906)
|
|
8/10/2001
|
|
3.2
|
|
|
|
3.3
|
|
Amended and Restated By-laws of Curis, Inc.
|
|
|
10-K
|
|
2/29/2016
|
|
3.3
|
|
|
|
|
|
Instruments defining the rights of security holders, including indentures
|
|
|
|
|
|
|
|
|
|
|
4.1
|
|
Form of Curis Common Stock Certificate
|
|
|
10-K
|
|
3/1/2004
|
|
4.1
|
|
|
|
4.2
|
|
Description of Registrants' Securities
|
|
|
|
|
|
|
|
|
X
|
|
|
|
Material contracts—Management Contracts and Compensatory Plans
|
|
|
|
|
|
|
|
|
|
|
#10.1
|
|
Employment Agreement, dated March 29, 2016, as amended September 24, 2018 by and between Curis, Inc. and James E. Dentzer.
|
|
|
10-Q
|
|
11/1/2018
|
|
10.2
|
|
|
|
#10.2
|
|
Employment Agreement, dated September 11, 2019 between Curis, Inc. and William E. Steinkrauss
|
|
|
10-Q
|
|
11/5/2019
|
|
10.1
|
|
|
|
|
|
|
|
|
Incorporated by Reference
|
||||||
Exhibit
No.
|
|
Description
|
|
Link to Filing
|
|
Form
|
|
SEC Filing
Date
|
|
Exhibit
Number
|
|
Filed with
this 10-K
|
#10.3
|
|
Employment Agreement, dated June 1, 2018, by and between Curis, Inc. and Robert E. Martell, M.D., Ph.D.
|
|
|
10-Q
|
|
8/2/2018
|
|
10.2
|
|
|
|
#10.4
|
|
Form of Indemnification Agreement, by and between Curis, Inc. and each non-employee director of the Board of Directors of Curis, Inc.
|
|
|
10-Q
|
|
8/7/2014
|
|
10.3
|
|
|
|
#10.5
|
|
Curis 2000 Stock Incentive Plan
|
|
|
S-4/A (333-32446)
|
|
5/31/2000
|
|
10.71
|
|
|
|
#10.6
|
|
Curis 2000 Director Stock Option Plan
|
|
|
S-4/A (333-32446)
|
|
5/31/2000
|
|
10.72
|
|
|
|
#10.7
|
|
Form of Incentive Stock Option Agreement for awards granted to named executive officers under Curis’ 2000 Stock Incentive Plan
|
|
|
10-Q
|
|
10/26/2004
|
|
10.2
|
|
|
|
#10.8
|
|
Form of Non-statutory Stock Option Agreement for awards granted to directors and named executive officers under Curis’ 2000 Stock Incentive Plan
|
|
|
10-Q
|
|
10/26/2004
|
|
10.3
|
|
|
|
#10.9
|
|
Form of Non-statutory Stock Option Agreement for awards granted to non-employee directors under Curis’ 2000 Director Stock Option Plan
|
|
|
10-Q
|
|
10/26/2004
|
|
10.4
|
|
|
|
#10.10
|
|
Curis 2010 Stock Incentive Plan
|
|
|
Def 14A
|
|
4/16/2010
|
|
Exhibit A
|
|
|
|
#10.11
|
|
Curis 2010 Employee Stock Purchase Plan
|
|
|
|
Def 14A
|
|
4/16/2010
|
|
Exhibit B
|
|
|
#10.12
|
|
Form of Incentive Stock Option Agreement for awards granted to named executive officers under Curis’ 2010 Stock Incentive Plan
|
|
|
8-K
|
|
6/4/2010
|
|
10.1
|
|
|
|
#10.13
|
|
Form of Non-Statutory Stock Option Agreement for awards granted to directors and named executive officers under Curis’ 2010 Stock Incentive Plan
|
|
|
8-K
|
|
6/4/2010
|
|
10.2
|
|
|
|
#10.14
|
|
Form of Restricted Stock Agreement for awards granted to directors and named executive officers under Curis’ 2010 Stock Incentive Plan
|
|
|
8-K
|
|
6/4/2010
|
|
10.3
|
|
|
|
#10.15
|
|
Curis Amended and Restated 2010 Stock Incentive Plan, as amended
|
|
|
8-K
|
|
5/28/2015
|
|
99.1
|
|
|
|
#10.16
|
|
Form of Incentive Stock Option Agreement for awards granted to named executive officers under Curis’ Amended and Restated 2010 Stock Incentive Plan, as amended
|
|
|
10-K
|
|
3/8/2018
|
|
10.21
|
|
|
|
#10.17
|
|
Form of Non-Statutory Stock Option Agreement for awards granted to directors and named executive officers under Curis’ Amended and Restated 2010 Stock Incentive Plan, as amended
|
|
|
10-K
|
|
3/8/2018
|
|
10.22
|
|
|
|
#10.18
|
|
Form of Restricted Stock Agreement for awards granted to directors and named executive officers under Curis’ Amended and Restated 2010 Stock Incentive Plan, as amended
|
|
|
10-K
|
|
3/8/2018
|
|
10.23
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Incorporated by Reference
|
||||||
Exhibit
No.
|
|
Description
|
|
Link to Filing
|
|
Form
|
|
SEC Filing
Date
|
|
Exhibit
Number
|
|
Filed with
this 10-K
|
#10.19
|
|
Form of Incentive Stock Option Agreement (Online Acceptance) for awards granted to named executive officers under Curis’ Amended and Restated 2010 Stock Incentive Plan
|
|
|
10-K
|
|
3/9/2017
|
|
10.21
|
|
|
|
#10.20
|
|
Form of Nonstatutory Stock Option Agreement (Online Acceptance) granted to directors and named executive officers under Curis’ Amended and Restated 2010 Stock Incentive Plan
|
|
|
10-K
|
|
3/9/2017
|
|
10.22
|
|
|
|
#10.21
|
|
Curis Second Amended and Restated 2010 Stock Incentive Plan
|
|
|
8-K
|
|
5/22/2017
|
|
99.1
|
|
|
|
#10.22
|
|
Form of Incentive Stock Option Agreement for awards granted to named executive officers under Curis’ Second Amended and Restated 2010 Stock Incentive Plan
|
|
|
10-K
|
|
3/8/2018
|
|
10.27
|
|
|
|
#10.23
|
|
Form of Non-Statutory Stock Option Agreement for awards granted to directors and named executive officers under Curis’ Second Amended and Restated 2010 Stock Incentive Plan
|
|
|
10-K
|
|
3/8/2018
|
|
10.28
|
|
|
|
#10.24
|
|
Form of Restricted Stock Agreement for awards granted to directors and named executive officers under Curis’ Second Amended and Restated 2010 Stock Incentive Plan
|
|
|
10-K
|
|
3/8/2018
|
|
10.29
|
|
|
|
#10.25
|
|
Form of Nonstatutory Stock Option Agreement - Inducement Grant pursuant to Nasdaq Stock Market Rule 5635(c)(4)
|
|
|
S-8
|
|
1/6/2017
|
|
99.1
|
|
|
|
#10.26
|
|
Curis Third Amended and Restated 2010 Stock Incentive Plan, as amended
|
|
|
8-K
|
|
5/30/2019
|
|
99.1
|
|
|
|
#10.27
|
|
Curis Amended and Restated 2010 Employee Stock Purchase Plan, as amended
|
|
|
10-K
|
|
3/8/2018
|
|
10.31
|
|
|
|
|
|
Material contracts—Leases
|
|
|
|
|
|
|
|
|
|
|
10.28
|
|
Lease, dated September 16, 2010, by and between Curis, Inc. and the Trustees of Lexington Office Realty Trust relating to the premises at 4 Maguire Road, Lexington, Massachusetts
|
|
|
8-K
|
|
9/21/2010
|
|
10.1
|
|
|
|
10.29
|
|
Second Amendment to Lease, dated November 1, 2017, by and between Curis, Inc. and the Trustees of Lexington Office Realty Trust relating to the premises at 4 Maguire Road, Lexington, Massachusetts
|
|
|
10-Q
|
|
11/7/2017
|
|
10.2
|
|
|
|
10.30
|
|
Lease, dated December 5, 2019, by and between Curis, Inc. and 128 Spring Street Lexington, LLC relating to the premises at 128 Spring Street, Lexington, Massachusetts
|
|
|
8-K
|
|
12/6/2019
|
|
10.1
|
|
|
|
|
|
Material contracts—Financing Agreements
|
|
|
|
|
|
|
|
|
|
|
10.31
|
|
Consent and Payment Direction Letter Agreement, dated November 20, 2012 and effective as of December 11, 2012 by and between Curis, Inc., Curis Royalty LLC and Genentech, Inc.
|
|
|
10-K
|
|
3/13/2013
|
|
10.32
|
|
|
|
10.32
|
|
Consent and Payment Direction Letter Agreement, dated March 3, 2017 by and between Curis, Inc., Curis Royalty LLC and Genentech, Inc.
|
|
|
10-K
|
|
3/9/2017
|
|
10.28
|
|
|
|
|
|
|
|
|
Incorporated by Reference
|
||||||
Exhibit
No.
|
|
Description
|
|
Link to Filing
|
|
Form
|
|
SEC Filing
Date
|
|
Exhibit
Number
|
|
Filed with
this 10-K
|
†10.33
|
|
Purchase and Sale Agreement, dated as of December 11, 2012 between Curis, Inc. and Curis Royalty LLC
|
|
|
10-K
|
|
3/13/2013
|
|
10.33
|
|
|
|
††10.34
|
|
Royalty Interest Purchase Agreement, dated March 22, 2019, by and between, Curis, Inc., Curis Royalty LLC, a wholly owned subsidiary of Curis, Inc., TPC Investments I LP and TPC Investments II LP
|
|
|
10-K
|
|
3/26/2019
|
|
10.40
|
|
|
|
10.35
|
|
Security Agreement, dated March 22, 2019, by and between, Curis Royalty LLC, a wholly owned subsidiary of Curis, Inc., TPC Investments I LP and TPC Investments II LP
|
|
|
10-K
|
|
3/26/2019
|
|
10.41
|
|
|
|
10.36
|
|
Pledge Agreement, dated March 22, 2019, by and between, Curis, Inc., TPC Investments I LP and TPC Investments II LP
|
|
|
10-K
|
|
3/26/2019
|
|
10.42
|
|
|
|
10.37
|
|
Consent and Payment Direction Letter Agreement, dated March 22, 2019, by and between Curis, Inc., Curis Royalty LLC and Genentech, Inc.
|
|
|
10-K
|
|
3/26/2019
|
|
10.43
|
|
|
|
|
|
Material contracts—License and Collaboration Agreements
|
|
|
|
|
|
|
|
|
|
|
†10.38
|
|
Collaborative Research, Development and License Agreement, dated June 11, 2003, by and between Curis, Inc. and Genentech, Inc.
|
|
|
10-Q
|
|
8/6/2015
|
|
10.1
|
|
|
|
†10.39
|
|
Collaboration, License and Option Agreement, dated January 18, 2015, by and between Curis, Inc. and Aurigene Discovery Technologies Limited
|
|
|
10-K
|
|
2/24/2015
|
|
10.32
|
|
|
|
†10.40
|
|
First Amendment to Collaboration, License and Option Agreement, dated September 7, 2016, by and between Curis, Inc. and Aurigene Discovery Technologies Limited
|
|
|
10-Q
|
|
11/3/2016
|
|
10.2
|
|
|
|
††10.41
|
|
Second Amendment to Collaboration, License and Option Agreement, dated February 5, 2020, by and between Curis, Inc. and Aurigene Discovery Technologies Limited
|
|
|
|
|
|
|
|
|
X
|
|
††10.42
|
|
Option and License Agreement, dated January 6, 2020 by and between Curis, Inc and ImmuNext, Inc.
|
|
|
|
|
|
|
|
|
X
|
|
|
|
Material contracts—Miscellaneous
|
|
|
|
|
|
|
|
|
|
|
10.43
|
|
Common Stock Purchase Agreement, dated January 18, 2015, by and between Curis, Inc. and Aurigene Discovery Technologies Limited
|
|
|
10-K
|
|
2/24/2015
|
|
10.34
|
|
|
|
10.44
|
|
Stock Purchase Agreement, dated September 7, 2016, by and between Curis, Inc. and Aurigene Discovery Technologies Limited
|
|
|
10-Q
|
|
11/3/2016
|
|
10.3
|
|
|
|
10.45
|
|
Registration Rights Agreement, dated January 18, 2015, by and between Curis, Inc. and Aurigene Discovery Technologies Limited
|
|
|
|
10-K
|
|
2/24/2015
|
|
10.35
|
|
|
10.46
|
|
Registration Rights Agreement, dated September 7, 2016, by and between Curis, Inc. and Aurigene Discovery Technologies Limited
|
|
|
10-Q
|
|
11/3/2016
|
|
10.4
|
|
|
|
10.47
|
|
Common Stock Purchase Agreement, dated February 26, 2020, by and between Curis, Inc. and Aspire Capital Fund, LLC
|
|
|
8-K
|
|
2/27/2020
|
|
10.1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Incorporated by Reference
|
||||||
Exhibit
No.
|
|
Description
|
|
Link to Filing
|
|
Form
|
|
SEC Filing
Date
|
|
Exhibit
Number
|
|
Filed with
this 10-K
|
10.48
|
|
Registration Rights Agreement, dated February 26, 2020, by and between Curis, Inc. and Aspire Capital Fund. LLC
|
|
|
8-K
|
|
2/27/2020
|
|
4.1
|
|
|
|
10.49
|
|
Sales Agreement, dated March 4, 2020, by and between Curis, Inc. and JonesTrading Institutional Services LLC
|
|
|
8-K
|
|
3/6/2020
|
|
1.1
|
|
|
|
|
|
Code of Conduct
|
|
|
|
|
|
|
|
|
|
|
14
|
|
Amended and Restated Code of Business Conduct and Ethics
|
|
|
10-K
|
|
3/8/2018
|
|
14
|
|
|
|
|
|
Additional Exhibits
|
|
|
|
|
|
|
|
|
|
|
21
|
|
Subsidiaries of Curis
|
|
|
|
|
|
|
|
|
X
|
|
23.1
|
|
Consent of PricewaterhouseCoopers LLP
|
|
|
|
|
|
|
|
|
X
|
|
31.1
|
|
Certification of the Chief Executive Officer pursuant to Rule 13a-14(a) of the Exchange Act/15d-14(a) of the Exchange Act
|
|
|
|
|
|
|
|
|
X
|
|
31.2
|
|
Certification of the Principal Financial Officer pursuant to Rule 13a-14(a) of the Exchange Act/15d-14(a) of the Exchange Act
|
|
|
|
|
|
|
|
|
X
|
|
32.1
|
|
Certification of the Chief Executive Officer pursuant to Rule 13a-14(b)/15d-14(b) of the Exchange Act and 18 U.S.C. Section 1350
|
|
|
|
|
|
|
|
|
X
|
|
32.2
|
|
Certification of the Chief Financial Officer pursuant to Rule 13a-14(b)/15d-14(b) of the Exchange Act and 18 U.S.C. Section 1350
|
|
|
|
|
|
|
|
|
X
|
|
101.INS
|
|
XBRL Instance Document
|
|
|
|
|
|
|
|
|
|
X
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document
|
|
|
|
|
|
|
|
|
|
X
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
|
|
|
|
|
|
|
|
X
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
|
|
|
|
|
|
|
|
X
|
101.LAB
|
|
XBRL Taxonomy Extension Label Linkbase Document
|
|
|
|
|
|
|
|
|
|
X
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
|
|
|
|
|
|
|
|
|
X
|
†
|
Confidential treatment has been granted as to certain portions, which portions have been separately filed with the Securities and Exchange Commission.
|
††
|
Confidential treatment has been requested as to certain portions, which portions have been separately filed with the Securities and Exchange Commission.
|
ITEM 16.
|
FORM 10-K SUMMARY
|
|
|
|
CURIS, INC.
|
||
|
|
|
By:
|
|
/s/ JAMES DENTZER
|
|
|
James Dentzer
President and Chief Executive Officer
|
|
|
|
|
|
Signature
|
|
Title
|
|
Date
|
|
|
|
||
/s/ JAMES DENTZER
|
|
President, Chief Executive Officer and Director (Principal Executive Officer)
|
|
March 19, 2020
|
James Dentzer
|
|
|
||
/s/ WILLIAM STEINKRAUSS
|
|
Chief Financial Officer (Principal Financial and Accounting Officer)
|
|
March 19, 2020
|
William Steinkrauss
|
|
|
||
/s/ MARTYN D. GREENACRE
|
|
Chairman of the Board of Directors
|
|
March 19, 2020
|
Martyn D. Greenacre
|
|
|
||
/s/ KENNETH I. KAITIN
|
|
Director
|
|
March 19, 2020
|
Kenneth I. Kaitin
|
|
|
||
/s/ LORI A. KUNKEL
|
|
Director
|
|
March 19, 2020
|
Lori A. Kunkel
|
|
|
||
/s/ MARC RUBIN
|
|
Director
|
|
March 19, 2020
|
Marc Rubin
|
|
|
|
|
•
|
a merger with, disposition of significant assets to or receipt of disproportionate financial benefits by the interested stockholder, and
|
•
|
any other transaction that would increase the interested stockholder’s proportionate ownership of any class or series of our capital stock.
|
•
|
prior to the time that any stockholder became an interested stockholder, the board of directors approved either the business combination or the transaction in which such stockholder acquired 15% or more of our outstanding voting stock, or
|
•
|
the interested stockholder owns at least 85% of our outstanding voting stock as a result of a transaction in which such stockholder acquired 15% or more of our outstanding voting stock. Shares held by persons who are both directors and officers or by some types of employee stock plans are not counted as outstanding when making this calculation.
|
Aurigene Discovery Technologies Limited
|
Curis, Inc.
|
By: /s/ Murali Ramachandra, Ph.D.
Name: Murali Ramachandra, Ph.D.
Title: Chief Executive Officer
|
By:/s/ James E. Dentzer
Name: James E. Dentzer
Title: President and CEO
|
Commercial Milestone Event
|
Commercial Milestone Payment (in US Dollars)
|
First Calendar Year in which worldwide annual Net Sales of Products equal or exceed $[**]
|
[**]
|
Cumulative Net Sales of Products first reach $[**]
|
[**]
|
Cumulative Net Sales of Products first reach $[**]
|
[**]
|
Cumulative Net Sales of Products first reach $[**]
|
[**]
|
Cumulative Net Sales of Products first reach $[**]
|
[**]
|
Cumulative Net Sales of Products first reach $[**]
|
[**]
|
Net Sales of a Product in a Calendar Year
|
Column A:
Royalty Rates for Net Sales occurring before the Royalty Reduction Date
|
Column B:
Royalty Rates for Net Sales occurring on after the Royalty Reduction Date
|
Portion less than or equal to $[**]
|
[**]%
|
[**]%
|
Portion greater than $[**] and less than or equal to $[**]
|
[**]%
|
[**]%
|
Portion greater than $[**] and less than or equal to $[**]
|
[**]%
|
[**]%
|
Portion greater than $[**] and less than or equal to $[**]
|
[**]%
|
[**]%
|
Portion greater than $[**]
|
[**]%
|
[**]%
|
Stage of Development of such Terminated Product as of the effective date of termination
|
Royalty Rate
|
Prior to [**] for such Terminated Product
|
[**]%
|
After [**] for such Terminated Product
|
[**]%
|
ImmuNext, Inc.
|
Curis, Inc.
|
By:/s/ David DeLucia
|
By:/s/ James Dentzer
|
Name: David DeLucia
|
Name:James Dentzer
|
Title: CEO
|
Title: President and CEO
|
|
/s/ PRICEWATERHOUSECOOPERS LLP
|
Boston, Massachusetts
|
March 19, 2020
|
1.
|
I have reviewed this Annual Report on Form 10-K of Curis, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
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c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
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d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Date:
|
March 19, 2020
|
/S/ JAMES E. DENTZER
|
|
|
James Dentzer
|
|
|
President and Chief Executive Officer
|
|
|
(Principal Executive Officer)
|
1.
|
I have reviewed this Annual Report on Form 10-K of Curis, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Date:
|
March 19, 2020
|
/S/ WILLIAM STEINKRAUSS
|
|
|
William Steinkrauss
|
|
|
Chief Financial Officer
|
|
|
(Principal Financial Officer)
|
Date:
|
March 19, 2020
|
/S/ JAMES E. DENTZER
|
|
|
James Dentzer
|
|
|
President and Chief Executive Officer
|
|
|
(Principal Executive Officer)
|
Date:
|
March 19, 2020
|
/S/ WILLIAM STEINKRAUSS
|
|
|
William Steinkrauss
|
|
|
Chief Financial Officer
|
|
|
(Principal Financial Officer)
|