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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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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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33-0903395
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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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2505 Meridian Parkway, Suite 100
Durham, North Carolina
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27713
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(Address of Principal Executive Offices)
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(Zip Code)
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Title of Each Class
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Name of Each Exchange on Which Registered
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Common Stock, par value $0.001 per share
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The NASDAQ Stock Market LLC
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Large accelerated filer
o
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Accelerated filer
x
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Non-accelerated filer
o
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Smaller reporting company
o
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Document Description
Portions of the registrant’s notice of annual meeting of stockholders and proxy statement to be filed pursuant to Regulation 14A within 120 days after registrant’s fiscal year end of December 31, 2016 are incorporated by reference into Part III of this report………………………………………………………
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10-K Part
III
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Page
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the initiation, cost, timing, progress and results of our research and development activities, preclinical studies and future clinical trials;
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our ability to obtain and maintain regulatory approval of our current and future product candidates, and any related restrictions, limitations, and/or warnings in the label of an approved product candidate;
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our ability to obtain funding for our operations;
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our plans to research, develop and commercialize our future product candidates;
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our strategic alliance partners’ election to pursue development and commercialization;
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our ability to attract collaborators with development, regulatory and commercialization expertise;
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our ability to obtain and maintain intellectual property protection for our future product candidates;
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the size and growth potential of the markets for our current and future product candidates, and our ability to serve those markets;
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our ability to successfully commercialize our current and future product candidates;
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the rate and degree of market acceptance of our current and future product candidates;
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our ability to develop sales and marketing capabilities, whether alone or with potential future collaborators;
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regulatory developments in the United States and foreign countries;
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the performance of our third-party suppliers and manufacturers;
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the success of competing therapies that are or become available;
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the loss of key scientific or management personnel;
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our use of the proceeds from our public offerings; and
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the accuracy of our estimates regarding expenses, future revenues, capital requirements and need for additional financing.
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I.
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Oral Formulations of Brincidofovir
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A.
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Oral Brincidofovir for Treatment of AdV
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Cohort A, comprised of allogeneic HCT recipients with asymptomatic or limited AdV infection;
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Cohort B, comprised of allogeneic HCT recipients with disseminated adenovirus disease; and
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Cohort C, comprised of autologous HCT recipients, solid organ transplant recipients and other patients with serious AdV infections.
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Mortality
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AdV-Associated Mortality
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Pediatric
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Responder*
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7/28 (25%)
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}
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p=0.031
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1/28 (4%)
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Non-responder
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7/13 (54%)
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2/13 (15%)
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Adult
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Responder*
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5/10 (50%)
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}
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p=0.0004
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0/10 (0%)
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Non-responder
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13/14 (93%)
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10/14 (71%)
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B.
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Oral Brincidofovir for Treatment of Smallpox
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C.
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Oral Brincidofovir Expanded Access Program
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II.
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Intravenous (IV) Formulation of Brincidofovir
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A.
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Preclinical Assessments of IV Brincidofovir in Rats
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B.
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IV Brincidofovir Single Ascending Dose Study in Healthy Subjects
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Cohort 1: IV BCV 10 mg (n=6) or placebo (n=2);
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Cohort 2: IV BCV 25 mg (n=6) or placebo (n=2);
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Cohort 3: IV BCV 50 mg given over 2 hours (n=9) or placebo (n=3); and
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Cohort 4: IV BCV 50 mg given over 4 hours (n=9) or placebo (n=3).
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C.
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Additional Studies Planned
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Advance Oral and IV Formulations of Brincidofovir for the Prevention and Treatment of DNA Virus Infections in HCT and SOT Recipients.
We are in the process of initiating a small comparative clinical trial designed to study the effect of brincidofovir versus standard of care in pediatric patients with AdV infection following allogeneic HCT (Study 999). The initial focus of the study will be in European clinical trial sites. If successful, Study 999 may form the basis of an application for conditional or full marketing approval of brincidofovir in the EU for the treatment of AdV infection in HCT recipients. We plan to discuss the design and conduct of this study with the FDA as well. We expect to initiate enrollment of Study 999 in the second half of 2017, which could lead to data as early as the end of 2018 and a potential approval in the EU by 2020.
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Progress Development of Brincidofovir as a Medical Countermeasure for the Treatment of Smallpox.
We have conducted efficacy studies under the FDA’s Animal Rule to demonstrate the impact of immediate or delayed brincidofovir in a validated model of smallpox infection. We are working with BARDA on design elements of a pivotal efficacy study in a second animal model of smallpox. If we obtain positive results from such a study, we
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Develop CMX521 for the Prevention and Treatment of Norovirus.
We are currently conducting final preclinical studies of CMX521 in animals. These studies are required to file an Investigational New Drug application (IND) that would allow clinical testing of CMX521 in humans. Assuming we receive positive results from our ongoing preclinical testing, we expect an IND could be filed during the latter half of 2017.
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Discover and Develop Additional Product Candidates to Strengthen our Product Portfolio.
We have an active discovery and preclinical development program focused on identifying and developing new compounds that can be used to treat diseases for which no current therapeutic option exists or which otherwise continue to have high unmet medical need. We intend to leverage our knowledge and experience of nucleoside analogs to advance compounds in the Chimerix Chemical Library through IND-enabling studies and potential clinical development and/or partnerships. In addition, we are exploring other potential product opportunities based on the ability of our proprietary lipid conjugate technology to significantly improve the drug profile of molecules with limitations in safety or delivery.
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Evaluate external opportunities to strengthen our pipeline.
We are looking at business development opportunities as a means to complement our existing pipeline with technologies that will take advantage of our strengths. We are actively seeking opportunities to grow our business through the acquisition of or investment in other companies, through strategic relationships, or through in-licensing of complementary compounds and products.
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Vistide® (cidofovir for injection), marketed by Gilead Sciences, Inc. and generic manufacturers; and
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patient-specific T-cell therapies.
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letermovir, an anti-CMV drug being developed for the prevention of CMV infections in adult HCT recipients pursuant to an exclusive worldwide license agreement between AiCuris GmbH & Co. KG and Merck;
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maribavir, an antiviral owned by Shire, currently in Phase 3 trials for the treatment of CMV resistant or refractory CMV infections in both HCT and SOT adult patients, and for preemptive use in adult HCT patients
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ASP0113 (TransVax), a CMV prevention vaccine, licensed to Astellas Pharma Inc. from Vical Incorporated and in development by Astellas and Vical; and
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patient-specific T-cell therapies directed at antigens of CMV and other dsDNA viruses.
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over 133 patents or patent applications that we own or have in-licensed from academic institutions, related to brincidofovir and CMX157, which represented a slight increase over the number of patents and patent applications in our patent portfolio at the end of fiscal 2015;
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21 patents and patent applications related to our agreement with the University of Michigan regarding our proprietary Chemical Library; and
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71 US and foreign exclusively and jointly owned patents, and 62 U.S., PCT, and foreign applications relating to brincidofovir or CMX157.
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completion of nonclinical laboratory tests, animal studies and formulation studies according to good laboratory practices (GLP), or other applicable regulations;
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submission to the FDA of an application for an IND, which must become effective before human clinical trials may begin;
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performance of adequate and well-controlled human clinical trials according to the FDA’s regulations commonly referred to as current good clinical practices (GCPs), to establish the safety and efficacy of the proposed drug for its intended use;
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submission to the FDA of a New Drug Application (NDA) for a new drug;
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satisfactory completion of an FDA inspection of the manufacturing facility or facilities where the drug is produced to assess compliance with the FDA’s current good manufacturing practice standards (cGMP), to assure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity;
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potential FDA inspection of the nonclinical and clinical trial sites that generated the data in support of the NDA; and FDA review of the NDA.
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Phase 1. The drug is initially introduced into healthy human subjects and tested for safety, dosage tolerance, absorption, metabolism, distribution and excretion. In the case of some products for severe or life-threatening diseases, especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients.
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Phase 2. The drug is evaluated in 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, optimal dosage and dosing schedule.
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Phase 3. Clinical trials are undertaken to further evaluate dosage, clinical efficacy and safety in an expanded patient population at geographically dispersed clinical trial sites. These clinical trials are intended to establish the overall risk/benefit ratio of the product and provide an adequate basis for product labeling. Generally, two adequate and well-controlled Phase 3 clinical trials are required by the FDA for approval of an NDA.
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aimed at treating, preventing or diagnosing seriously debilitating or life-threatening diseases;
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intended for use in emergency situations (also less comprehensive pharmaceutical and non-clinical data may be accepted for such products); and/or
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designated as orphan medicines.
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it must be intended for the treatment, prevention or diagnosis of a disease that is life-threatening or chronically debilitating;
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the prevalence of the condition in the EU must not be more than 5 in 10,000 or it must be unlikely that marketing of the medicine would generate sufficient returns to justify the investment needed for its development; and
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no satisfactory method of diagnosis, prevention or treatment of the condition concerned can be authorized, or, if such a method exists, the medicine must be of significant benefit to those affected by the condition.
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continue the development of our lead product candidate, brincidofovir, for the treatment of adenovirus (AdV) infection;
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continue the development of brincidofovir for the prevention or treatment of cytomegalovirus (CMV), AdV, BK virus, and other viral indications in hematopoietic cell transplant (HCT) recipients, solid organ transplant recipients and other patient populations;
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continue the development of brincidofovir for the treatment of smallpox as a medical countermeasure;
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advance the development of an intravenous (IV) formulation of brincidofovir;
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obtain regulatory approvals for brincidofovir;
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scale-up manufacturing capabilities to commercialize brincidofovir for any indications for which we receive regulatory approval;
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conduct IND-enabling studies and initiate clinical development of CMX521 for norovirus;
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expand our research and development activities and advance our clinical programs;
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maintain, expand and protect our intellectual property portfolio;
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continue our research and development efforts and seek to discover additional product candidates; and
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add operational, financial and management information systems and personnel, including personnel to support our product development and commercialization efforts and operations as a public company.
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obtaining favorable results for and advancing the development of brincidofovir and our other product candidates, including successfully completing clinical development of IV and oral formulations of brincidofovir;
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obtaining United States and foreign regulatory approval(s) for brincidofovir;
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launching and commercializing brincidofovir, including establishing a sales force and/or collaborating with third party providers of sales organizations;
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achieving broad market acceptance of brincidofovir in the medical community and with third-party payers;
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delivering a competitive value proposition compared to established competition and/or competitors who will enter the market before or after any of our product candidates, including brincidofovir; and
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generating, licensing or otherwise acquiring a pipeline of product candidates which progress to clinical development, regulatory approval, and commercialization.
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significantly delay, scale back or discontinue the development or commercialization of our product candidates, including brincidofovir;
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seek corporate partners for brincidofovir or any of our other product candidates at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available; or
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relinquish or license on unfavorable terms, our rights to technologies or product candidates that we otherwise would seek to develop or commercialize ourselves.
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successful conduct of required trial(s) of oral brincidofovir for the treatment of adenovirus;
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successful conduct of a second efficacy study of oral brincidofovir in an animal model of smallpox infection, and acceptance of data from these animal model studies by the FDA and foreign regulatory bodies;
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development of an IV formulation and/or alternate drug formulations;
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receipt of marketing approvals from the FDA and corresponding regulatory authorities outside the United States;
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establishing commercial manufacturing capabilities;
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launching commercial sales of the product, whether alone or in collaboration with others;
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acceptance of the product by patients, the medical community and third-party payers;
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effectively competing with other therapies;
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a continued acceptable safety profile of the product following approval; and
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obtaining, maintaining, enforcing and defending intellectual property rights and claims.
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regulators or institutional review boards may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;
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clinical trials of our product candidates may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon product development programs;
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animal efficacy studies of our product candidates may produce negative or inconclusive results, and we may decide, or regulators may require us to conduct additional animal efficacy studies or abandon development programs;
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we might be required to change one of our clinical research organizations (CROs) during ongoing clinical programs;
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the number of subjects required for clinical trials of our product candidates may be larger than we anticipate, enrollment in these clinical trials may be insufficient or slower than we anticipate or subjects may drop out of these clinical trials at a higher rate than we anticipate;
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our third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;
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we may have to suspend or terminate clinical trials of our product candidates for various reasons, including a finding that the subjects are being exposed to unacceptable health risks;
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regulators or institutional review boards may require that we or our investigators suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements;
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the cost of clinical trials of our product candidates may be greater than we anticipate;
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we may encounter agency or judicial enforcement actions which impact our clinical trials;
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the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate; or
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our product candidates may have undesirable side effects or other unexpected characteristics, causing us or our investigators to suspend or terminate the trials.
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inability to raise funding necessary to initiate or continue a trial;
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delays in obtaining, or failure to obtain, regulatory approval to commence a trial;
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delays in reaching agreement with the FDA and foreign health authorities on final trial design;
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imposition of a clinical hold following an inspection of our clinical trial operations or trial sites by the FDA or other regulatory authorities;
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delays caused by disagreements with existing CROs and/or clinical trial sites;
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delays in reaching agreement on acceptable terms with prospective CROs and clinical trial sites;
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delays in obtaining required institutional review board approval at each site;
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delays in recruiting suitable patients to participate in a trial;
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delays in having subjects complete participation in a trial or return for post-treatment follow-up;
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delays caused by subjects dropping out of a trial due to side effects or otherwise;
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clinical sites dropping out of a trial to the detriment of enrollment;
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agency or judicial enforcement actions against us;
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time required to add new clinical sites; and
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delays by our contract manufacturers to produce and deliver sufficient supply of clinical trial materials.
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regulatory authorities may approve the product only with a risk evaluation and mitigation strategy (REMS), potentially with restrictions on distribution and other elements to assure safe use (ETASU);
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regulatory authorities may withdraw their approval of the product or impose restrictions on its distribution in a form of a modified REMS;
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regulatory authorities may require the addition of labeling statements, such as warnings or contraindications;
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we may be required to change the way the product is administered or to conduct additional clinical studies;
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we could be sued and held liable for harm caused to patients; and
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our reputation may suffer.
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issue an untitled or warning letter asserting that we are in violation of the law;
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seek an injunction or impose civil or criminal penalties or monetary fines;
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suspend or withdraw regulatory approval;
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suspend any ongoing clinical trials;
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refuse to approve a pending application or supplements to an application submitted by us;
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recall and/or seize product; or
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refuse to allow us to enter into supply contracts, including government contracts.
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the federal healthcare anti-kickback statute which prohibits, among other things, persons or entities from knowingly and willfully soliciting, offering, receiving or paying remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, lease, order or recommendation of, any good, facility, item or service, for which payment may be made, in whole or in part, under federal healthcare programs such as Medicare and Medicaid;
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the federal civil and criminal false claims laws and civil monetary penalties, including civil whistleblower or
qui tam
actions, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, to the federal government, claims for payment or approval that are false or fraudulent or from knowingly making a false statement to improperly 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 (HIPAA) which, among other things, imposes criminal liability for knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or to obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payer (e.g., public or private) and knowingly or willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statement in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters;
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HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (HITECH) and its implementing regulations, and as amended again by the final HIPAA omnibus rule, Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules Under HITECH and the Genetic Information Nondiscrimination Act; Other Modifications to HIPAA, published in January 2013, which imposes certain obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information without appropriate authorization by entities subject to the rule, such as health plans, clearinghouses and healthcare providers;
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the federal Food, Drug and Cosmetic Act (FDCA) which prohibits, among other things, the adulteration or misbranding of drugs and devices;
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the federal transparency law, enacted as part of the Patient Protection and Affordable Care Act and Health Care and Education Reconciliation Act of 2010 (collectively, the Health Care Reform Law), and its implementing regulations, which requires manufacturers of drugs, devices, biologicals and medical supplies to report to the U.S. Department of Health and Human Services information related to payments and other transfers of value made to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members; and
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analogous state laws and regulations, including: state anti-kickback and false claims laws, which may apply to our business practices, including but not limited to, research, distribution, sales and marketing arrangements and claims involving healthcare items or services reimbursed by state governmental and non-governmental third-party payers, including private insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government; and state laws and regulations that require manufacturers to file reports relating to pricing and marketing information, which requires tracking gifts and other remuneration and items of value provided to healthcare professionals and entities.
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inability to meet our product specifications and quality requirements consistently;
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delay or inability to procure or expand sufficient manufacturing capacity;
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manufacturing and product quality issues related to scale-up of manufacturing;
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costs and validation of new equipment and facilities required for scale-up;
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failure to comply with cGMP and similar foreign standards;
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inability to negotiate manufacturing agreements with third parties under commercially reasonable terms;
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termination or nonrenewal of manufacturing agreements with third parties in a manner or at a time that is costly or damaging to us;
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reliance on a limited number of sources, and in some cases, single sources for product components, such that if we are unable to secure a sufficient supply of these product components, we will be unable to manufacture and sell our product candidates in a timely fashion, in sufficient quantities or under acceptable terms;
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lack of qualified backup suppliers for those components that are currently purchased from a sole or single source supplier;
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operations of our third-party manufacturers or suppliers could be disrupted by conditions unrelated to our business or operations, including the bankruptcy of the manufacturer or supplier;
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carrier disruptions or increased costs that are beyond our control; and
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failure to deliver our products under specified storage conditions and in a timely manner.
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lacks or does not devote sufficient time and resources to the development and commercialization of CMX157;
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lacks or does not devote sufficient capital to fund the development and commercialization of CMX157;
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develops, either alone or with others, products that compete with CMX157;
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fails to gain the requisite regulatory approvals for CMX157;
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does not successfully commercialize CMX157;
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does not conduct its activities in a timely manner;
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terminates its license with us;
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does not effectively pursue and enforce intellectual property rights relating to CMX157; or
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merges with a third-party that wants to terminate the collaboration.
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demonstration of clinical safety and efficacy in our clinical trials;
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relative convenience, ease of administration and acceptance by physicians, patients, pharmacists and health care payers;
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prevalence and severity of any AEs;
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limitations or warnings contained in the FDA-approved labeling from Regulatory Authorities such as the FDA and EMA for the relevant product candidate;
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availability of alternative treatments;
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pricing and cost-effectiveness;
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effectiveness of our or any future collaborators’ sales and marketing strategies;
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ability to obtain hospital formulary approval;
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ability to ensure availability for product through appropriate channels;
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ability to maintain adequate inventory; and
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ability to obtain and maintain sufficient third-party coverage or reimbursement, which may vary from country to country.
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recruiting and retaining talented people;
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training employees that we recruit;
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establishing compliance standards;
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setting the appropriate system of incentives;
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managing additional headcount;
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ensuring that appropriate support functions are in place to support sales force organizational needs; and
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integrating a new business unit into an existing corporate architecture.
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different regulatory requirements for drug approvals in the EU and other foreign countries;
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reduced protection for intellectual property rights;
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unexpected changes in tariffs, trade barriers and regulatory and labor requirements;
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economic weakness, including inflation, or political instability in particular foreign economies and markets;
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compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;
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foreign taxes, including withholding of payroll taxes;
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foreign currency fluctuations, which could result in increased operating expenses and reduced revenues, and other obligations incident to doing business in another country;
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workforce uncertainty in countries where labor unrest is more common than in the United States;
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production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad;
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business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters including earthquakes, typhoons, floods and fires; and
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regulatory and compliance risks that relate to maintaining accurate information and control over activities that may fall within the purview of the U.S. Foreign Corrupt Practices Act, its books and records provisions or its anti‑bribery provisions, or similar anti‑bribery or anti‑corruption laws and regulations.
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Vistide® (cidofovir for injection), marketed by Gilead Sciences, Inc. and generic manufacturers;
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oral and intravenous ganciclovir, a drug that is sold by generic manufacturers;
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Valcyte® (valganciclovir), a prodrug of ganciclovir that is marketed by Genentech, Inc. and generic manufacturers;
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foscarnet sodium for injection available through generic manufacturers;
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acyclovir, a drug that is sold by generic manufacturers; and
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investigational patient-specific T-cell therapies.
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letermovir, an anti-CMV drug being developed pursuant to an exclusive worldwide license agreement between AiCuris GmbH & Co. KG and Merck;
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maribavir (SHP620) from Shire for CMV infections in transplant recipients;
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ASP0113 (TransVax), a CMV prevention vaccine, licensed to Astellas Pharma Inc. from Vical Incorporated and in development by Astellas and Vical; and
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patient-specific T-cell therapies directed at antigens of CMV and other DNA viruses, including AdV.
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discover and develop medicines that are superior to other products in the market;
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demonstrate through our clinical trials that our product candidates, including brincidofovir, are differentiated from existing and future therapies;
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evaluate new potential indications across the lifecycle of brincidofovir;
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attract qualified scientific, product development and commercial personnel;
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obtain and successfully defend and enforce patent and/or other proprietary protection for our medicines and technologies;
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obtain required regulatory approvals;
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•
|
successfully collaborate with pharmaceutical companies in the discovery, development and commercialization of new medicines;
|
•
|
deliver a competitive value proposition compared to established competition and/or competitors who will enter the market before or after any of our product candidates, including brincidofovir; and
|
•
|
negotiate competitive pricing and reimbursement with third-party payers.
|
•
|
our research methodology or that of our collaboration partners may be unsuccessful in identifying potential product candidates;
|
•
|
our potential product candidates may be shown to have harmful side effects or may have other characteristics that may make the products unmarketable or unlikely to receive marketing approval; and
|
•
|
our collaboration partners may change their development profiles for potential product candidates or abandon a therapeutic area.
|
•
|
audit and object to any BARDA contract-related costs and fees on grounds that they are not allowable under the FAR, and require us to reimburse all such costs and fees;
|
•
|
suspend or prevent us for a set period of time from receiving new contracts or extending our existing contract based on violations or suspected violations of laws or regulations;
|
•
|
claim nonexclusive, nontransferable rights to product manufactured and intellectual property developed under the BARDA contract and may, under certain circumstances, such as circumstances involving public health and safety, license such inventions to third parties without our consent;
|
•
|
cancel, terminate or suspend our BARDA contract based on violations or suspected violations of laws or regulations;
|
•
|
terminate our BARDA contract in whole or in part for the convenience of the government for any reason or no reason, including if funds become unavailable to the applicable governmental agency;
|
•
|
reduce the scope and value of our BARDA contract;
|
•
|
decline to exercise an option to continue the BARDA contract;
|
•
|
direct the course of a development program in a manner not chosen by the government contractor;
|
•
|
require us to perform the option segments even if doing so may cause us to forego or delay the pursuit of other opportunities with greater commercial potential;
|
•
|
take actions that result in a longer development timeline than expected; and
|
•
|
change certain terms and conditions in our BARDA contract.
|
•
|
FAR, and agency-specific regulations supplements to the FAR, which comprehensively regulate the procurement, formation, administration and performance of government contracts and implement federal procurement policy in numerous areas, such as employment practices, protection of the environment, accuracy and retention periods of records, recording and charging of costs, treatment of laboratory animals and human subject research;
|
•
|
business ethics and public integrity obligations, which govern conflicts of interest and the hiring of former government employees, restrict the granting of gratuities and funding of lobbying activities and incorporate other requirements such as the Anti-Kickback Act and the Foreign Corrupt Practices Act;
|
•
|
export and import control laws and regulations; and
|
•
|
laws, regulations and executive orders restricting the use and dissemination of information classified for national security purposes and the exportation of certain products and technical data.
|
•
|
termination of contracts;
|
•
|
forfeiture of profits;
|
•
|
suspension of payments;
|
•
|
fines; and
|
•
|
suspension or prohibition from conducting business with the U.S. government.
|
•
|
impairment of our business reputation and significant negative media attention;
|
•
|
withdrawal of participants from our clinical studies;
|
•
|
significant costs to defend the related litigation and related litigation;
|
•
|
distraction of management’s attention from our primary business;
|
•
|
substantial monetary awards to patients or other claimants;
|
•
|
inability to commercialize our product candidates, including brincidofovir; and
|
•
|
decreased demand for our product candidates, if approved for commercial sale.
|
•
|
multiple, conflicting and changing laws and regulations such as tax laws, privacy regulations, export and import restrictions, employment, immigration and labor laws, regulatory requirements, and other governmental approvals, permits and licenses;
|
•
|
difficulties in staffing and managing foreign operations;
|
•
|
risks associated with obtaining and maintaining, or the failure to obtain or maintain, regulatory approvals for the sale or use of our products in various countries;
|
•
|
complexities associated with managing government payer systems, multiple payer-reimbursement regimes or patient self-pay systems;
|
•
|
financial risks, such as longer payment cycles, difficulty enforcing contracts and collecting accounts receivable and exposure to foreign currency exchange rate fluctuations;
|
•
|
general political and economic conditions in the countries in operate, including terrorism and political unrest, curtailment of trade and other business restrictions;
|
•
|
regulatory and compliance risks that relate to maintaining accurate information and control over activities that may fall within the purview of the U.S. Foreign Corrupt Practices Act, its books and records provisions or its anti-bribery provisions, or similar anti-bribery or anti-corruption laws and regulations.
|
•
|
results of clinical trials of our product candidates or those of our competitors;
|
•
|
any delay in filing an application for any of our product candidates and any adverse development or perceived adverse development with respect to regulatory review of that application;
|
•
|
failure to successfully develop and commercialize our product candidates, including brincidofovir;
|
•
|
termination of any of our license or collaboration agreements;
|
•
|
any agency or judicial enforcement actions against us;
|
•
|
inability to obtain additional funding;
|
•
|
regulatory or legal developments in the United States and other countries applicable to our product candidates;
|
•
|
adverse regulatory decisions;
|
•
|
changes in the structure of healthcare payment systems;
|
•
|
inability to obtain adequate product supply for our product candidates, or the inability to do so at acceptable prices;
|
•
|
introduction of new products, services or technologies by our competitors;
|
•
|
failure to meet or exceed financial projections we provide to the public;
|
•
|
failure to meet or exceed the estimates and projections of the investment community;
|
•
|
changes in the market valuations of similar companies;
|
•
|
market conditions in the pharmaceutical and biotechnology sectors, and the issuance of new or changed securities analysts’ reports or recommendations;
|
•
|
announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us or our competitors;
|
•
|
significant lawsuits (including patent or stockholder litigation), and disputes or other developments relating to proprietary rights (including patents, litigation matters and our ability to obtain patent protection for our technologies);
|
•
|
additions or departures of key scientific or management personnel;
|
•
|
sales of our common stock by us or our stockholders in the future;
|
•
|
trading volume of our common stock;
|
•
|
general economic, industry and market conditions; and
|
•
|
the other factors described in this “Risk Factors” section.
|
•
|
authorizing the issuance of “blank check” preferred stock, the terms of which may be established and shares of which may be issued without stockholder approval which could be used to institute a “poison pill” that would work to dilute the stock ownership of a potential hostile acquirer, effectively preventing acquisitions that have not been approved by our board of directors;
|
•
|
allowing the authorized number of our directors to be changed only by resolution of our board of directors;
|
•
|
limiting the removal of directors;
|
•
|
creating a staggered board of directors;
|
•
|
requiring that stockholder actions must be effected at a duly called stockholder meeting and prohibiting stockholder actions by written consent;
|
•
|
eliminating the ability of stockholders to call a special meeting of stockholders; and
|
•
|
establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted upon at duly called stockholder meetings.
|
|
Year Ended December 31, 2016
|
||||||
|
High
|
|
Low
|
||||
First Quarter
|
$
|
9.72
|
|
|
$
|
4.36
|
|
Second Quarter
|
$
|
6.47
|
|
|
$
|
3.50
|
|
Third Quarter
|
$
|
5.96
|
|
|
$
|
3.71
|
|
Fourth Quarter
|
$
|
5.64
|
|
|
$
|
3.66
|
|
|
|
|
|
||||
|
Year Ended December 31, 2015
|
||||||
|
High
|
|
Low
|
||||
First Quarter
|
$
|
43.41
|
|
|
$
|
34.51
|
|
Second Quarter
|
$
|
47.46
|
|
|
$
|
33.37
|
|
Third Quarter
|
$
|
58.04
|
|
|
$
|
35.62
|
|
Fourth Quarter
|
$
|
43.37
|
|
|
$
|
6.43
|
|
|
Years Ended December 31,
|
||||||||||||||||||
Consolidated Statement of Operations and Comprehensive Loss Data
|
2016
|
|
2015
|
|
2014
|
|
2013
|
|
2012
|
||||||||||
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Contract revenue
|
$
|
5,702
|
|
|
$
|
9,214
|
|
|
$
|
4,040
|
|
|
$
|
4,370
|
|
|
$
|
16,275
|
|
Collaboration and licensing revenue
|
—
|
|
|
1,548
|
|
|
—
|
|
|
—
|
|
|
17,445
|
|
|||||
Total revenues
|
5,702
|
|
|
10,762
|
|
|
4,040
|
|
|
4,370
|
|
|
33,720
|
|
|||||
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Research and development
|
58,647
|
|
|
97,717
|
|
|
45,379
|
|
|
24,662
|
|
|
30,106
|
|
|||||
General and administrative
|
25,007
|
|
|
31,296
|
|
|
17,527
|
|
|
8,327
|
|
|
6,397
|
|
|||||
Total operating expenses
|
83,654
|
|
|
129,013
|
|
|
62,906
|
|
|
32,989
|
|
|
36,503
|
|
|||||
Loss from operations
|
(77,952
|
)
|
|
(118,251
|
)
|
|
(58,866
|
)
|
|
(28,619
|
)
|
|
(2,783
|
)
|
|||||
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Interest income (expense), net
|
1,562
|
|
|
879
|
|
|
(446
|
)
|
|
(1,236
|
)
|
|
(776
|
)
|
|||||
Fair value adjustments to preferred stock warrant liability
|
—
|
|
|
—
|
|
|
—
|
|
|
(6,590
|
)
|
|
(847
|
)
|
|||||
Net loss
|
(76,390
|
)
|
|
(117,372
|
)
|
|
(59,312
|
)
|
|
(36,445
|
)
|
|
(4,406
|
)
|
|||||
Accretion of redeemable convertible preferred stock
|
—
|
|
|
—
|
|
|
—
|
|
|
(34,108
|
)
|
|
(4,357
|
)
|
|||||
Net loss attributable to common shareholders
|
$
|
(76,390
|
)
|
|
$
|
(117,372
|
)
|
|
$
|
(59,312
|
)
|
|
$
|
(70,553
|
)
|
|
$
|
(8,763
|
)
|
Net loss per share, basic and diluted
|
$
|
(1.65
|
)
|
|
$
|
(2.67
|
)
|
|
$
|
(1.80
|
)
|
|
$
|
(3.65
|
)
|
|
$
|
(5.75
|
)
|
Weighted-average shares outstanding, basic and diluted
|
46,267,064
|
|
|
43,878,326
|
|
|
33,003,714
|
|
|
19,307,422
|
|
|
1,524,628
|
|
|
Years Ended December 31,
|
||||||||||||||||||
Consolidated Balance Sheet Data
|
2016
|
|
2015
|
|
2014
|
|
2013
|
|
2012
|
||||||||||
Cash and cash equivalents
|
$
|
51,463
|
|
|
$
|
20,605
|
|
|
$
|
128,462
|
|
|
$
|
109,976
|
|
|
$
|
19,906
|
|
Short-term investments, available-for-sale (1)
|
180,558
|
|
|
199,729
|
|
|
106,114
|
|
|
—
|
|
|
9,849
|
|
|||||
Working capital
|
226,360
|
|
|
208,658
|
|
|
220,390
|
|
|
102,802
|
|
|
23,931
|
|
|||||
Long-term investments (1)
|
47,407
|
|
|
124,040
|
|
|
52,973
|
|
|
—
|
|
|
—
|
|
|||||
Total assets
|
286,770
|
|
|
355,992
|
|
|
291,878
|
|
|
113,387
|
|
|
32,031
|
|
|||||
Loan payable, net, current portion (2)
|
—
|
|
|
—
|
|
|
4,296
|
|
|
5,573
|
|
|
4,753
|
|
|||||
Loan payable, net, less current portion (2)
|
—
|
|
|
—
|
|
|
—
|
|
|
4,294
|
|
|
9,867
|
|
|||||
Redeemable convertible preferred stock warrant liability
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
7,512
|
|
|||||
Redeemable convertible preferred stock
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
107,723
|
|
|||||
Accumulated deficit
|
(415,804
|
)
|
|
(339,414
|
)
|
|
(222,042
|
)
|
|
(162,730
|
)
|
|
(101,032
|
)
|
|||||
Total stockholders’ equity (deficit)
|
$
|
276,224
|
|
|
$
|
335,459
|
|
|
$
|
274,636
|
|
|
$
|
98,539
|
|
|
$
|
(101,031
|
)
|
(1)
|
Further details of investments is available in "Notes to Consolidated Financial Statements, Note 1.
Fair Value of Financial Instruments"
in Item 8 of this Annual Report.
|
•
|
Cohort 1: IV BCV 10 mg (n=6) or placebo (n=2);
|
•
|
Cohort 2: IV BCV 25 mg (n=6) or placebo (n=2);
|
•
|
Cohort 3: IV BCV 50 mg given over 2 hours (n=9) or placebo (n=3); and
|
•
|
Cohort 4: IV BCV 50 mg given over 4 hours (n=9) or placebo (n=3).
|
•
|
Cohort A, comprised of allogeneic HCT recipients with asymptomatic or limited adenovirus infection;
|
•
|
Cohort B, comprised of allogeneic HCT recipients with disseminated adenovirus disease; and
|
•
|
Cohort C, comprised of autologous HCT recipients, solid organ transplant recipients and other patients with serious adenovirus infections.
|
|
Mortality
|
AdV-Associated Mortality
|
|||
Pediatric
|
Responder*
|
7/28 (25%)
|
}
|
p=0.031
|
1/28 (4%)
|
Non-responder
|
7/13 (54%)
|
2/13 (15%)
|
|||
Adult
|
Responder*
|
5/10 (50%)
|
}
|
p=0.0004
|
0/10 (0%)
|
Non-responder
|
13/14 (93%)
|
10/14 (71%)
|
•
|
fees paid to consultants and contract research organizations (CROs), including in connection with our preclinical and clinical trials, and other related clinical trial fees, such as for investigator grants, patient screening, laboratory work, clinical trial database management, clinical trial material management and statistical compilation and analysis;
|
•
|
salaries and related overhead expenses, which include stock option and employee stock purchase program compensation and benefits, for personnel in research and development functions;
|
•
|
payments to third-party manufacturers, which produce, test and package our drug substance and drug product (including continued testing of process validation and stability);
|
•
|
costs related to legal and compliance with regulatory requirements; and
|
•
|
license fees for and milestone payments related to licensed products and technologies.
|
|
Years Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Direct research and development expenses
|
$
|
31,415
|
|
|
$
|
70,348
|
|
|
$
|
31,392
|
|
Research and development personnel costs
|
22,172
|
|
|
22,269
|
|
|
11,235
|
|
|||
Indirect research and development expenses
|
5,060
|
|
|
5,100
|
|
|
2,752
|
|
|||
Total research and development expenses
|
$
|
58,647
|
|
|
$
|
97,717
|
|
|
$
|
45,379
|
|
•
|
the uncertainty of the scope, rate of progress and expense of our ongoing, as well as any additional, clinical trials and other research and development activities;
|
•
|
the potential benefits of our candidates over other therapies;
|
•
|
the ability to market, commercialize and achieve market acceptance for any of our product candidates that we are developing or may develop in the future;
|
•
|
the results of ongoing or future clinical trials;
|
•
|
the timing and receipt of any regulatory approvals; and
|
•
|
the filing, prosecuting, defending and enforcing of patent claims and other intellectual property rights, and the expense of doing so.
|
|
Years Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Income Statement Classification:
|
|
|
|
|
|
||||||
Research and development expense
|
$
|
7,137
|
|
|
$
|
5,578
|
|
|
$
|
1,085
|
|
General and administrative expense
|
9,086
|
|
|
7,381
|
|
|
3,326
|
|
|||
Total stock-based compensation expense
|
$
|
16,223
|
|
|
$
|
12,959
|
|
|
$
|
4,411
|
|
•
|
We have limited operating history to estimate the volatility of our common stock price. We calculate expected volatility based on a blend of company specific historical data and a group of similar publicly traded companies for which the historical information is available. For the purpose of identifying peer companies, we consider characteristics such as industry, length of trading history, similar vesting terms and in-the-money option status. We plan to continue to use the guideline peer group volatility information until the historical volatility of our common stock is relevant to measure expected volatility for future option grants.
|
•
|
We use historical exercise data to estimate expected term.
|
•
|
We determine the risk-free interest rate by reference to implied yields available from U.S. Treasury securities with a remaining term equal to the expected life assumed at the date of grant.
|
•
|
The assumed dividend yield is based on our expectation of not paying dividends for the foreseeable future.
|
•
|
We estimate forfeitures based on our historical analysis of actual stock option forfeitures.
|
|
Years Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Expected volatility
|
85.16
|
%
|
|
66.89
|
%
|
|
71.47
|
%
|
|||
Expected term (in years)
|
6.0
|
|
|
6.0
|
|
|
6.0
|
|
|||
Weighted-average risk-free interest rate
|
1.70
|
%
|
|
1.53
|
%
|
|
1.91
|
%
|
|||
Expected dividend yield
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|||
Weighted-average fair value per option
|
$
|
5.62
|
|
|
$
|
25.18
|
|
|
$
|
14.01
|
|
|
Years Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Expected volatility
|
111.57
|
%
|
|
57.77
|
%
|
|
74.24
|
%
|
|||
Expected term (in years)
|
1.37
|
|
|
1.15
|
|
|
0.8
|
|
|||
Weighted-average risk-free interest rate
|
0.75
|
%
|
|
0.43
|
%
|
|
0.09
|
%
|
|||
Expected dividend yield
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|||
Weighted-average option value per share
|
$
|
3.20
|
|
|
$
|
22.10
|
|
|
$
|
9.93
|
|
|
Years Ended December 31,
|
|
Dollar Change
|
|
% Change
|
|||||||||
|
2016
|
|
2015
|
|
Increase/(Decrease)
|
|||||||||
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|||
Contract revenue
|
$
|
5,702
|
|
|
$
|
9,214
|
|
|
$
|
(3,512
|
)
|
|
(38.1
|
)%
|
Collaboration and licensing revenue
|
—
|
|
|
1,548
|
|
|
(1,548
|
)
|
|
(100.0
|
)%
|
|||
Total revenues
|
5,702
|
|
|
10,762
|
|
|
(5,060
|
)
|
|
(47.0
|
)%
|
|||
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|||
Research and development
|
58,647
|
|
|
97,717
|
|
|
(39,070
|
)
|
|
(40.0
|
)%
|
|||
General and administrative
|
25,007
|
|
|
31,296
|
|
|
(6,289
|
)
|
|
(20.1
|
)%
|
|||
Total operating expenses
|
83,654
|
|
|
129,013
|
|
|
(45,359
|
)
|
|
(35.2
|
)%
|
|||
Loss from operations
|
(77,952
|
)
|
|
(118,251
|
)
|
|
40,299
|
|
|
(34.1
|
)%
|
|||
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|||||
Interest income (expense), net
|
1,562
|
|
|
879
|
|
|
683
|
|
|
77.7
|
%
|
|||
Net loss
|
$
|
(76,390
|
)
|
|
$
|
(117,372
|
)
|
|
$
|
40,982
|
|
|
(34.9
|
)%
|
•
|
a decrease of $31.0 million in oral BCV clinical expenses, comprised primarily of a decrease related to the completion of our Phase 3 SUPPRESS and AdVise clinical trials and the closeout of our SUSTAIN and SURPASS clinical trials;
|
•
|
a decrease of $3.1 million in costs related to the development of oral BCV drug manufacturing, and
|
•
|
a decrease in other research and development expenses, offset by
|
•
|
increases in costs of approximately $3.6 million related to the development of an IV formulation of brincidofovir and development of CMX521, the company's asset for norovirus
|
•
|
a decrease of $7.1 million as we delayed our commercialization readiness activities for brincidofovir;
|
•
|
a decrease of $1.2 million in operational support costs as part of our cost-saving efforts; offset by
|
•
|
a net increase in compensation and other employee related costs of $1.9 million, consisting of an increase of $1.7 million of share-based compensation and an increase of $0.2 million of compensation and benefits.
|
|
Years Ended December 31,
|
|
Dollar Change
|
|
% Change
|
|||||||||
|
2015
|
|
2014
|
|
Increase/(Decrease)
|
|||||||||
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|||
Contract revenue
|
$
|
9,214
|
|
|
$
|
4,040
|
|
|
$
|
5,174
|
|
|
128.1
|
%
|
Collaboration and licensing revenue
|
1,548
|
|
|
—
|
|
|
1,548
|
|
|
*
|
|
|||
Total revenues
|
10,762
|
|
|
4,040
|
|
|
6,722
|
|
|
166.4
|
%
|
|||
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|||
Research and development
|
97,717
|
|
|
45,379
|
|
|
52,338
|
|
|
115.3
|
%
|
|||
General and administrative
|
31,296
|
|
|
17,527
|
|
|
13,769
|
|
|
78.6
|
%
|
|||
Total operating expenses
|
129,013
|
|
|
62,906
|
|
|
66,107
|
|
|
105.1
|
%
|
|||
Loss from operations
|
(118,251
|
)
|
|
(58,866
|
)
|
|
(59,385
|
)
|
|
100.9
|
%
|
|||
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|||
Interest income (expense), net
|
879
|
|
|
(446
|
)
|
|
1,325
|
|
|
(297.1
|
)%
|
|||
Net loss
|
$
|
(117,372
|
)
|
|
$
|
(59,312
|
)
|
|
$
|
(58,060
|
)
|
|
97.9
|
%
|
•
|
an increase in clinical trial expenses of $30.9 million primarily related to our Phase 3 SUPPRESS and AdVise studies, as well as the costs of initiating our Phase 3 SUSTAIN and SURPASS studies, which we have since closed;
|
•
|
an increase in compensation and other employee related costs of $11.0 million, consisting of $6.5 million of compensation and benefit expense related to the addition of new employees to our clinical, regulatory, development and manufacturing departments and $4.5 million of share-based compensation;
|
•
|
an increase in drug manufacturing costs of $5.7 million for raw materials as we began primary and secondary brincidofovir manufacturing campaigns;
|
•
|
an increase of $2.9 million in legal and consulting expenses mainly related to the preparation of regulatory filings; and
|
•
|
an increase in animal studies of $1.0 million related to work under the BARDA contract and other preclinical development expenses.
|
•
|
an increase in compensation and other employee related costs of $5.9 million, consisting of an increase of $4.1 million of share-based compensation and $1.8 million of compensation and benefits related to the addition of new employees;
|
•
|
an increase in other costs of $4.9 million as we expanded our commercialization preparations for brincidofovir; and
|
•
|
an increase of $1.8 million in legal, accounting and consulting costs.
|
|
Years Ended December 31,
|
||||||||||
Cash sources and uses:
|
2016
|
|
2015
|
|
2014
|
||||||
Net cash used in operating activities
|
$
|
(63,815
|
)
|
|
$
|
(99,708
|
)
|
|
$
|
(47,077
|
)
|
Net cash provided by (used in) investing activities
|
94,065
|
|
|
(169,496
|
)
|
|
(159,700
|
)
|
|||
Net cash provided by financing activities
|
608
|
|
|
161,347
|
|
|
225,263
|
|
|||
Net increase (decrease) in cash and cash equivalents
|
$
|
30,858
|
|
|
$
|
(107,857
|
)
|
|
$
|
18,486
|
|
•
|
the willingness of the FDA and/or foreign regulators to accept the results from Study 999, as well as our other completed and planned clinical and preclinical studies and other work, as the basis for review and approval of brincidofovir for the treatment of adenovirus infection;
|
•
|
the progress, costs, results and timing of future clinical trials of brincidofovir for other potential indications, including prevention of multiple DNA virus infections and treatment of AdV, BKV and smallpox;
|
•
|
the willingness of the FDA and/or foreign regulators to accept clinical and preclinical studies and other work, as the basis for review and approval of brincidofovir for other potential indications;
|
•
|
the outcome, costs and timing of seeking and obtaining FDA and any other regulatory approvals;
|
•
|
the ability to continue to receive government funding;
|
•
|
the achievement of milestones under our agreement with ContraVir;
|
•
|
the number and characteristics of product candidates that we pursue, including our product candidates in preclinical development;
|
•
|
the ability of our product candidates to progress through clinical development successfully;
|
•
|
our need to expand our research and development activities;
|
•
|
the costs associated with securing, establishing and maintaining commercialization and manufacturing capabilities;
|
•
|
the costs of acquiring, licensing or investing in businesses, products, product candidates and technologies;
|
•
|
our ability to maintain, expand and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with the licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights;
|
•
|
our need and ability to hire additional management and scientific and medical personnel;
|
•
|
the effect of competing technological and market developments;
|
•
|
our need to implement additional internal systems and infrastructure, including financial and reporting systems; and
|
•
|
the economic and other terms, timing and success of our existing licensing arrangements and any collaboration, licensing or other arrangements into which we may enter in the future.
|
|
Total
|
|
Less Than 1 Year
|
|
1 – 3 Years
|
|
3 – 5 Years
|
|
More Than 5 Years
|
||||||||||
Operating leases (1)
|
$
|
3,033
|
|
|
$
|
826
|
|
|
$
|
1,423
|
|
|
$
|
784
|
|
|
$
|
—
|
|
Total
|
$
|
3,033
|
|
|
$
|
826
|
|
|
$
|
1,423
|
|
|
$
|
784
|
|
|
$
|
—
|
|
(1)
|
Consists of our corporate headquarters lease encompassing
29,053
square feet of office space that expires in February 2021, and our laboratory leases encompassing a total of approximately
10,274
square feet which are located in Durham and Research Triangle Park, North Carolina and expire in June 2018 and August 2018, respectively.
|
|
Page
|
Reports of Independent Registered Public Accounting Firm
|
|
Consolidated Balance Sheets as of December 31, 2016 and 2015
|
|
Consolidated Statements of Operations and Comprehensive Loss for the Years Ended December 31, 2016, 2015 and 2014
|
|
Consolidated Statements of Stockholders’ Equity (Deficit) for the Years Ended December 31, 2016, 2015 and 2014
|
|
Consolidated Statements of Cash Flows for the Years Ended December 31, 2016, 2015 and 2014
|
|
Notes to Consolidated Financial Statements
|
|
/s/ Ernst & Young LLP
|
|
/s/ Ernst & Young LLP
|
|
Years Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Revenues:
|
|
|
|
|
|
|
|
|
|||
Contract revenue
|
$
|
5,702
|
|
|
$
|
9,214
|
|
|
$
|
4,040
|
|
Collaboration and licensing revenue
|
—
|
|
|
1,548
|
|
|
—
|
|
|||
Total revenues
|
5,702
|
|
|
10,762
|
|
|
4,040
|
|
|||
Operating expenses:
|
|
|
|
|
|
|
|
|
|||
Research and development
|
58,647
|
|
|
97,717
|
|
|
45,379
|
|
|||
General and administrative
|
25,007
|
|
|
31,296
|
|
|
17,527
|
|
|||
Total operating expenses
|
83,654
|
|
|
129,013
|
|
|
62,906
|
|
|||
Loss from operations
|
(77,952
|
)
|
|
(118,251
|
)
|
|
(58,866
|
)
|
|||
Other income (expense):
|
|
|
|
|
|
|
|
|
|||
Interest income (expense), net
|
1,562
|
|
|
879
|
|
|
(446
|
)
|
|||
Net loss
|
(76,390
|
)
|
|
(117,372
|
)
|
|
(59,312
|
)
|
|||
Other comprehensive loss:
|
|
|
|
|
|
|
|
|
|||
Unrealized gain (loss) on investments, net
|
324
|
|
|
(799
|
)
|
|
35
|
|
|||
Comprehensive loss
|
$
|
(76,066
|
)
|
|
$
|
(118,171
|
)
|
|
$
|
(59,277
|
)
|
Per share information:
|
|
|
|
|
|
|
|
|
|||
Net loss, basic and diluted
|
$
|
(1.65
|
)
|
|
$
|
(2.67
|
)
|
|
$
|
(1.80
|
)
|
Weighted-average shares outstanding, basic and diluted
|
46,267,064
|
|
|
43,878,326
|
|
|
33,003,714
|
|
|
Common
Stock |
|
Additional
Paid-in Capital |
|
Accumulated Other
Comprehensive Gain (Loss) |
|
Accumulated
Deficit |
|
Total
Stockholders’ Equity (Deficit) |
||||||||||
Balance, December 31, 2013
|
$
|
26
|
|
|
$
|
261,243
|
|
|
$
|
—
|
|
|
$
|
(162,730
|
)
|
|
$
|
98,539
|
|
Share-based compensation
|
—
|
|
|
4,411
|
|
|
—
|
|
|
—
|
|
|
4,411
|
|
|||||
Exercise of stock options
|
2
|
|
|
4,591
|
|
|
—
|
|
|
—
|
|
|
4,593
|
|
|||||
Exercise of warrants
|
—
|
|
|
6
|
|
|
—
|
|
|
—
|
|
|
6
|
|
|||||
Employee stock purchase plan purchases
|
1
|
|
|
425
|
|
|
—
|
|
|
—
|
|
|
426
|
|
|||||
Issuance of 8,395,000 shares of common stock at $14.22 per share, net of issuance costs of $7,531
|
8
|
|
|
111,837
|
|
|
—
|
|
|
—
|
|
|
111,845
|
|
|||||
Issuance of 4,197,500 shares of common stock at $29.00 per share, net of issuance costs of $7,634
|
4
|
|
|
114,089
|
|
|
—
|
|
|
—
|
|
|
114,093
|
|
|||||
Comprehensive loss:
|
|
|
|
|
|
|
|
|
|
||||||||||
Unrealized gain on investments, net
|
—
|
|
|
—
|
|
|
35
|
|
|
—
|
|
|
35
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(59,312
|
)
|
|
(59,312
|
)
|
|||||
Total comprehensive loss
|
|
|
|
|
|
|
|
|
(59,277
|
)
|
|||||||||
Balance, December 31, 2014
|
41
|
|
|
496,602
|
|
|
35
|
|
|
(222,042
|
)
|
|
274,636
|
|
|||||
Share-based compensation
|
—
|
|
|
12,959
|
|
|
—
|
|
|
—
|
|
|
12,959
|
|
|||||
Exercise of stock options
|
—
|
|
|
2,107
|
|
|
—
|
|
|
—
|
|
|
2,107
|
|
|||||
Exercise of warrants
|
1
|
|
|
1,000
|
|
|
—
|
|
|
—
|
|
|
1,001
|
|
|||||
Employee stock purchase plan purchases
|
—
|
|
|
1,048
|
|
|
—
|
|
|
—
|
|
|
1,048
|
|
|||||
Issuance of 4,341,250 shares of common stock at $39.75 per share, net of issuance cost of $10,685
|
4
|
|
|
161,875
|
|
|
—
|
|
|
—
|
|
|
161,879
|
|
|||||
Comprehensive loss:
|
|
|
|
|
|
|
|
|
|
||||||||||
Unrealized loss on investments, net
|
—
|
|
|
—
|
|
|
(799
|
)
|
|
—
|
|
|
(799
|
)
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(117,372
|
)
|
|
(117,372
|
)
|
|||||
Total comprehensive loss
|
|
|
|
|
|
|
|
|
(118,171
|
)
|
|||||||||
Balance, December 31, 2015
|
46
|
|
|
675,591
|
|
|
(764
|
)
|
|
(339,414
|
)
|
|
335,459
|
|
|||||
Share-based compensation
|
—
|
|
|
16,223
|
|
|
—
|
|
|
—
|
|
|
16,223
|
|
|||||
Exercise of stock options
|
—
|
|
|
168
|
|
|
—
|
|
|
—
|
|
|
168
|
|
|||||
Employee stock purchase plan purchases
|
—
|
|
|
440
|
|
|
—
|
|
|
—
|
|
|
440
|
|
|||||
Comprehensive loss:
|
|
|
|
|
|
|
|
|
|
||||||||||
Unrealized gain on investments, net
|
—
|
|
|
—
|
|
|
324
|
|
|
—
|
|
|
324
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(76,390
|
)
|
|
(76,390
|
)
|
|||||
Total comprehensive loss
|
|
|
|
|
|
|
|
|
(76,066
|
)
|
|||||||||
Balance, December 31, 2016
|
$
|
46
|
|
|
$
|
692,422
|
|
|
$
|
(440
|
)
|
|
$
|
(415,804
|
)
|
|
$
|
276,224
|
|
|
Years Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Cash flows from operating activities:
|
|
|
|
|
|
|
|
|
|||
Net loss
|
$
|
(76,390
|
)
|
|
$
|
(117,372
|
)
|
|
$
|
(59,312
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
|||
Depreciation of property and equipment
|
1,063
|
|
|
657
|
|
|
283
|
|
|||
Amortization of debt costs
|
—
|
|
|
64
|
|
|
148
|
|
|||
Amortization of premium/discount on investments
|
1,223
|
|
|
1,622
|
|
|
1,175
|
|
|||
Share-based compensation
|
16,223
|
|
|
12,959
|
|
|
4,411
|
|
|||
Amortization of lease-related obligations
|
132
|
|
|
19
|
|
|
(19
|
)
|
|||
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|||
Accounts receivable
|
861
|
|
|
(2,354
|
)
|
|
142
|
|
|||
Prepaid expenses and other assets
|
3,215
|
|
|
(3,028
|
)
|
|
(107
|
)
|
|||
Accounts payable and accrued liabilities
|
(10,142
|
)
|
|
7,725
|
|
|
6,202
|
|
|||
Net cash used in operating activities
|
(63,815
|
)
|
|
(99,708
|
)
|
|
(47,077
|
)
|
|||
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
|||
Purchases of property and equipment
|
(841
|
)
|
|
(2,393
|
)
|
|
(1,018
|
)
|
|||
Purchases of short-term investments
|
(23,992
|
)
|
|
(60,297
|
)
|
|
(155,433
|
)
|
|||
Purchases of long-term investments
|
(79,381
|
)
|
|
(234,791
|
)
|
|
(55,337
|
)
|
|||
Sales of short-term investments
|
—
|
|
|
1,003
|
|
|
3,499
|
|
|||
Maturities of short-term investments
|
198,279
|
|
|
126,742
|
|
|
48,589
|
|
|||
Maturities of long-term investments
|
—
|
|
|
240
|
|
|
—
|
|
|||
Net cash provided by (used in) investing activities
|
94,065
|
|
|
(169,496
|
)
|
|
(159,700
|
)
|
|||
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
|||
Proceeds from exercise of stock options
|
168
|
|
|
2,107
|
|
|
4,593
|
|
|||
Proceeds from employee stock purchase plan stock purchases
|
440
|
|
|
1,048
|
|
|
426
|
|
|||
Proceeds from exercise of warrants
|
—
|
|
|
1,001
|
|
|
6
|
|
|||
Proceeds from public offerings, net of offering costs
|
—
|
|
|
161,879
|
|
|
225,938
|
|
|||
Payments for deferred financing costs
|
—
|
|
|
(338
|
)
|
|
—
|
|
|||
Repayments of debt
|
—
|
|
|
(4,350
|
)
|
|
(5,700
|
)
|
|||
Net cash provided by financing activities
|
608
|
|
|
161,347
|
|
|
225,263
|
|
|||
Net increase (decrease) in cash and cash equivalents
|
30,858
|
|
|
(107,857
|
)
|
|
18,486
|
|
|||
Cash and cash equivalents:
|
|
|
|
|
|
|
|
|
|||
Beginning of period
|
20,605
|
|
|
128,462
|
|
|
109,976
|
|
|||
End of period
|
$
|
51,463
|
|
|
$
|
20,605
|
|
|
$
|
128,462
|
|
Supplemental disclosure of cash flow information
|
|
|
|
|
|
|
|
|
|||
Cash paid for interest
|
$
|
—
|
|
|
$
|
158
|
|
|
$
|
614
|
|
Non-cash acquisition of investment in U.S. corporation
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,545
|
|
•
|
Level 1
— Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access.
|
•
|
Level 2
— Valuations based on quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, and models for which all significant inputs are observable, either directly or indirectly.
|
•
|
Level 3
— Valuations based on inputs that are unobservable and significant to the overall fair value measurement.
|
|
|
|
Fair Value Measurements
|
|
|
||||||||||
|
|
|
December 31, 2016
|
|
|
||||||||||
|
Total
|
|
Quoted Prices in
Active Markets for Identical Assets (Level 1) |
|
Significant Other
Observable Inputs (Level 2) |
|
Significant
Unobservable Inputs (Level 3) |
||||||||
Cash equivalents
|
|
|
|
|
|
|
|
||||||||
Money market funds
|
$
|
15,733
|
|
|
$
|
15,733
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Commercial paper
|
35,097
|
|
|
—
|
|
|
35,097
|
|
|
—
|
|
||||
Total cash equivalents
|
50,830
|
|
|
15,733
|
|
|
35,097
|
|
|
—
|
|
||||
Short-term investments
|
|
|
|
|
|
|
|
||||||||
Certificates of deposit
|
7,450
|
|
|
—
|
|
|
7,450
|
|
|
—
|
|
||||
U.S. Treasury securities
|
171,822
|
|
|
171,822
|
|
|
—
|
|
|
—
|
|
||||
Common stock of U.S. corporation
|
1,286
|
|
|
1,286
|
|
|
—
|
|
|
—
|
|
||||
Total short-term investments
|
180,558
|
|
|
173,108
|
|
|
7,450
|
|
|
—
|
|
||||
Long-term investments
|
|
|
|
|
|
|
|
||||||||
U.S. Treasury securities
|
47,407
|
|
|
47,407
|
|
|
—
|
|
|
—
|
|
||||
Total long-term investments
|
47,407
|
|
|
47,407
|
|
|
—
|
|
|
—
|
|
||||
Total assets
|
$
|
278,795
|
|
|
$
|
236,248
|
|
|
$
|
42,547
|
|
|
$
|
—
|
|
|
|
|
Fair Value Measurements
|
|
|
||||||||||
|
|
|
December 31, 2015
|
|
|
||||||||||
|
Total
|
|
Quoted Prices in
Active Markets for Identical Assets (Level 1) |
|
Significant Other
Observable Inputs (Level 2) |
|
Significant
Unobservable Inputs (Level 3) |
||||||||
Cash equivalents
|
|
|
|
|
|
|
|
||||||||
Money market funds
|
$
|
19,795
|
|
|
$
|
19,795
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Total cash equivalents
|
19,795
|
|
|
19,795
|
|
|
—
|
|
|
—
|
|
||||
Short-term investments
|
|
|
|
|
|
|
|
||||||||
Certificates of deposit
|
23,030
|
|
|
—
|
|
|
23,030
|
|
|
—
|
|
||||
U.S. Treasury securities
|
175,214
|
|
|
175,214
|
|
|
—
|
|
|
—
|
|
||||
Preferred stock of U.S. corporation
|
1,485
|
|
|
—
|
|
|
—
|
|
|
1,485
|
|
||||
Total short-term investments
|
199,729
|
|
|
175,214
|
|
|
23,030
|
|
|
1,485
|
|
||||
Long-term investments
|
|
|
|
|
|
|
|
||||||||
Certificates of deposit
|
7,668
|
|
|
—
|
|
|
7,668
|
|
|
—
|
|
||||
U.S. Treasury securities
|
116,372
|
|
|
116,372
|
|
|
—
|
|
|
—
|
|
||||
Total long-term investments
|
124,040
|
|
|
116,372
|
|
|
7,668
|
|
|
—
|
|
||||
Total assets
|
$
|
343,564
|
|
|
$
|
311,381
|
|
|
$
|
30,698
|
|
|
$
|
1,485
|
|
|
Fair Value Measurements
(Level 3)
|
||
Preferred stock of U.S. corporation:
|
|
||
Fair value at January 1, 2014
|
$
|
—
|
|
Investment acquired
|
1,545
|
|
|
Fair value increase recorded in other comprehensive loss
|
236
|
|
|
Fair value at December 31, 2014
|
1,781
|
|
|
Fair value decrease recorded in other comprehensive loss
|
(296
|
)
|
|
Fair value at December 31, 2015
|
1,485
|
|
|
Fair value decrease recorded in other comprehensive loss
|
(371
|
)
|
|
Fair value transferred to Level 2
|
(1,114
|
)
|
|
Fair value at December 31, 2016
|
$
|
—
|
|
|
December 31,
|
||||||
|
2016
|
|
2015
|
||||
Prepaid research and development expenses
|
$
|
843
|
|
|
$
|
4,165
|
|
Interest receivable
|
772
|
|
|
670
|
|
||
Prepaid insurance
|
389
|
|
|
385
|
|
||
Other prepaid expenses and current assets
|
841
|
|
|
851
|
|
||
Total prepaid expenses and other current assets
|
$
|
2,845
|
|
|
$
|
6,071
|
|
|
December 31,
|
||||||
|
2016
|
|
2015
|
||||
Accrued compensation
|
$
|
2,906
|
|
|
$
|
2,939
|
|
Accrued research and development expenses
|
2,257
|
|
|
3,596
|
|
||
Other accrued liabilities
|
1,052
|
|
|
3,186
|
|
||
Total accrued liabilities
|
$
|
6,215
|
|
|
$
|
9,721
|
|
|
December 31, 2016
|
||||||||||||||
|
Amortized Cost
|
|
Gross Unrealized
Gains |
|
Gross Unrealized
Losses |
|
Estimated
Fair Value |
||||||||
Certificates of deposit
|
$
|
7,445
|
|
|
$
|
5
|
|
|
$
|
—
|
|
|
$
|
7,450
|
|
U.S. Treasury securities
|
219,415
|
|
|
15
|
|
|
(201
|
)
|
|
219,229
|
|
||||
Common stock of U.S. corporation
|
1,545
|
|
|
—
|
|
|
(259
|
)
|
|
1,286
|
|
||||
Total investments
|
$
|
228,405
|
|
|
$
|
20
|
|
|
$
|
(460
|
)
|
|
$
|
227,965
|
|
|
December 31, 2015
|
||||||||||||||
|
Amortized Cost
|
|
Gross Unrealized
Gains |
|
Gross Unrealized
Losses |
|
Estimated
Fair Value |
||||||||
Certificates of deposit
|
$
|
30,724
|
|
|
$
|
2
|
|
|
$
|
(28
|
)
|
|
$
|
30,698
|
|
U.S. Treasury securities
|
292,264
|
|
|
—
|
|
|
(678
|
)
|
|
291,586
|
|
||||
Preferred stock of U.S. corporation
|
1,545
|
|
|
—
|
|
|
(60
|
)
|
|
1,485
|
|
||||
Total investments
|
$
|
324,533
|
|
|
$
|
2
|
|
|
$
|
(766
|
)
|
|
$
|
323,769
|
|
|
|
December 31, 2016
|
||||||||||||||||||||||
|
|
Less than 12 Months
|
|
Greater than 12 Months
|
|
Total
|
||||||||||||||||||
|
|
Fair Value
|
|
Unrealized Loss
|
|
Fair Value
|
|
Unrealized Loss
|
|
Fair Value
|
|
Unrealized Loss
|
||||||||||||
U.S. Treasury securities
|
|
128,204
|
|
|
(201
|
)
|
|
—
|
|
|
—
|
|
|
128,204
|
|
|
(201
|
)
|
||||||
Common stock of U.S. corporation
|
|
1,286
|
|
|
(259
|
)
|
|
—
|
|
|
—
|
|
|
1,286
|
|
|
(259
|
)
|
||||||
Total
|
|
$
|
129,490
|
|
|
$
|
(460
|
)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
129,490
|
|
|
$
|
(460
|
)
|
Number of securities with unrealized losses
|
|
|
|
24
|
|
|
|
|
—
|
|
|
|
|
24
|
|
|
|
December 31, 2015
|
||||||||||||||||||||||
|
|
Less than 12 Months
|
|
Greater than 12 Months
|
|
Total
|
||||||||||||||||||
|
|
Fair Value
|
|
Unrealized Loss
|
|
Fair Value
|
|
Unrealized Loss
|
|
Fair Value
|
|
Unrealized Loss
|
||||||||||||
Certificates of deposit
|
|
$
|
24,450
|
|
|
$
|
(28
|
)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
24,450
|
|
|
$
|
(28
|
)
|
U.S. Treasury securities
|
|
291,586
|
|
|
(678
|
)
|
|
—
|
|
|
—
|
|
|
291,586
|
|
|
(678
|
)
|
||||||
Preferred stock of U.S. corporation
|
|
1,485
|
|
|
(60
|
)
|
|
—
|
|
|
—
|
|
|
1,485
|
|
|
$
|
(60
|
)
|
|||||
Total
|
|
$
|
317,521
|
|
|
$
|
(766
|
)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
317,521
|
|
|
$
|
(766
|
)
|
Number of securities with unrealized losses
|
|
|
|
180
|
|
|
|
|
—
|
|
|
|
|
180
|
|
|
December 31, 2016
|
||
Maturing in one year or less
|
$
|
179,272
|
|
Maturing after one year through two years
|
47,407
|
|
|
Total debt investments
|
$
|
226,679
|
|
Common stock of U.S. corporation
|
1,286
|
|
|
Total investments
|
$
|
227,965
|
|
|
December 31,
|
||||||
|
2016
|
|
2015
|
||||
Lab equipment
|
$
|
2,419
|
|
|
$
|
1,946
|
|
Leasehold improvements
|
1,570
|
|
|
1,463
|
|
||
Computer equipment
|
1,262
|
|
|
1,063
|
|
||
Office furniture and equipment
|
586
|
|
|
536
|
|
||
Property and equipment
|
5,837
|
|
|
5,008
|
|
||
Less accumulated depreciation
|
(2,994
|
)
|
|
(1,963
|
)
|
||
Property and equipment, net of accumulated depreciation
|
$
|
2,843
|
|
|
$
|
3,045
|
|
Years Ending December 31,
|
Minimum Rental Payment
|
||
2017
|
$
|
825
|
|
2018
|
759
|
|
|
2019
|
665
|
|
|
2020
|
672
|
|
|
2021
|
112
|
|
|
Total future minimum rental payments
|
$
|
3,033
|
|
Years Ending December 31,
|
Minimum Sublease Rentals
|
||
2017
|
$
|
60
|
|
2018
|
74
|
|
|
2019
|
77
|
|
|
2020
|
81
|
|
|
2021
|
14
|
|
|
Total future minimum sublease rentals
|
$
|
306
|
|
|
December 31,
|
||||
|
2016
|
|
2015
|
||
For exercise of common stock warrants
|
227,794
|
|
|
227,794
|
|
For exercise of outstanding common stock options
|
4,342,466
|
|
|
2,746,395
|
|
For delivery upon vesting of outstanding restricted stock units
|
946,200
|
|
|
—
|
|
For future equity awards under the 2013 Equity Incentive Plan
|
662,180
|
|
|
1,609,791
|
|
For future purchases under the 2013 Employee Stock Purchase Plan
|
1,612,759
|
|
|
1,298,333
|
|
Total shares of common stock reserved for future issuances
|
7,791,399
|
|
|
5,882,313
|
|
|
Years Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Expected volatility
|
85.16
|
%
|
|
66.89
|
%
|
|
71.47
|
%
|
|||
Expected term (in years)
|
6.0
|
|
|
6.0
|
|
|
6.0
|
|
|||
Weighted-average risk-free interest rate
|
1.70
|
%
|
|
1.53
|
%
|
|
1.91
|
%
|
|||
Expected dividend yield
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|||
Weighted-average fair value per option
|
$
|
5.62
|
|
|
$
|
25.18
|
|
|
$
|
14.01
|
|
|
Number of Options
Outstanding |
|
Weighted-Average
Exercise Price |
|
Weighted-Average
Remaining Contractual Life (in Years) |
|
Total Intrinsic Value
|
||||||
Balance, January 1, 2015
|
1,859,970
|
|
|
$
|
15.79
|
|
|
8.46
|
|
|
|
||
Granted
|
1,249,683
|
|
|
41.80
|
|
|
—
|
|
|
|
|||
Exercised
|
(292,581
|
)
|
|
7.22
|
|
|
—
|
|
|
|
|||
Forfeited
|
(70,677
|
)
|
|
30.78
|
|
|
—
|
|
|
|
|||
Balance, December 31, 2015
|
2,746,395
|
|
|
$
|
28.19
|
|
|
8.41
|
|
|
|
||
Granted
|
2,418,551
|
|
|
7.76
|
|
|
—
|
|
|
|
|||
Exercised
|
(48,441
|
)
|
|
3.48
|
|
|
—
|
|
|
|
|||
Forfeited
|
(774,039
|
)
|
|
24.13
|
|
|
—
|
|
|
|
|||
Balance, December 31, 2016
|
4,342,466
|
|
|
$
|
17.81
|
|
|
8.09
|
|
|
$
|
540,234
|
|
Exercisable at December 31, 2016
|
2,033,315
|
|
|
$
|
19.77
|
|
|
7.44
|
|
|
$
|
483,421
|
|
Vested or expected to vest at December 31, 2016
|
4,275,950
|
|
|
$
|
17.83
|
|
|
8.08
|
|
|
$
|
537,904
|
|
|
|
Years Ended December 31,
|
||||||||||
|
|
2016
|
|
2015
|
|
2014
|
||||||
Weighted-average grant-date fair value per share of options granted
|
|
$
|
5.62
|
|
|
$
|
25.18
|
|
|
$
|
14.01
|
|
Total intrinsic value of options exercised
|
|
$
|
119
|
|
|
$
|
10,139
|
|
|
$
|
30,438
|
|
Total fair value of shares vested
|
|
$
|
13,330
|
|
|
$
|
11,498
|
|
|
$
|
4,696
|
|
|
|
Outstanding
|
|
Exercisable
|
||||||||||||
Range
|
|
Number
|
|
Weighted-Average Remaining Contractual Life (in years)
|
|
Weighted-Average Exercise Price
|
|
Number
|
|
Weighted-Average Exercise Price
|
||||||
$1.53 to 7.57
|
|
504,307
|
|
|
5.85
|
|
$
|
4.00
|
|
|
399,862
|
|
|
$
|
3.89
|
|
7.58 to 8.06
|
|
1,927,576
|
|
|
9.02
|
|
8.06
|
|
|
456,715
|
|
|
8.06
|
|
||
15.79 to 18.75
|
|
423,521
|
|
|
7.05
|
|
17.83
|
|
|
313,439
|
|
|
17.84
|
|
||
18.76 to 39.17
|
|
599,121
|
|
|
7.56
|
|
25.43
|
|
|
398,537
|
|
|
25.04
|
|
||
39.18 to 53.74
|
|
887,941
|
|
|
8.21
|
|
41.67
|
|
|
464,762
|
|
|
41.71
|
|
||
$1.53 to 53.74
|
|
4,342,466
|
|
|
8.09
|
|
$
|
17.81
|
|
|
2,033,315
|
|
|
$
|
19.77
|
|
|
Years Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Expected volatility
|
111.57
|
%
|
|
57.77
|
%
|
|
74.24
|
%
|
|||
Expected term (in years)
|
1.37
|
|
|
1.15
|
|
|
0.8
|
|
|||
Weighted-average risk-free interest rate
|
0.75
|
%
|
|
0.43
|
%
|
|
0.09
|
%
|
|||
Expected dividend yield
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|||
Weighted-average option value per share
|
$
|
3.20
|
|
|
$
|
22.10
|
|
|
$
|
9.93
|
|
|
Number of Restricted
Stock Units Outstanding |
Weighted-Average Grant-Date Fair Value
|
|||
Balance, January 1, 2016
|
—
|
|
|
||
Granted
|
1,209,000
|
|
$
|
4.91
|
|
Share issuance
|
(203,400
|
)
|
4.91
|
|
|
Forfeited
|
(59,400
|
)
|
4.91
|
|
|
Balance, December 31, 2016
|
946,200
|
|
$
|
4.91
|
|
|
Years Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Income Statement Classification:
|
|
|
|
|
|
||||||
Research and development expense
|
$
|
7,137
|
|
|
$
|
5,578
|
|
|
$
|
1,085
|
|
General and administrative expense
|
9,086
|
|
|
7,381
|
|
|
3,326
|
|
|||
Total stock-based compensation expense
|
$
|
16,223
|
|
|
$
|
12,959
|
|
|
$
|
4,411
|
|
|
2016
|
|
2015
|
|
2014
|
|||||||||||||||
|
Amount
|
|
% of Pretax
Earnings |
|
Amount
|
|
% of Pretax
Earnings |
|
Amount
|
|
% of Pretax
Earnings |
|||||||||
Income tax benefit at statutory rate
|
$
|
(25,973
|
)
|
|
34.0
|
%
|
|
$
|
(39,907
|
)
|
|
34.0
|
%
|
|
$
|
(20,166
|
)
|
|
34.0
|
%
|
State income taxes
|
(1,544
|
)
|
|
2.0
|
%
|
|
(2,176
|
)
|
|
1.9
|
%
|
|
(1,343
|
)
|
|
2.3
|
%
|
|||
Research and development credits
|
(2,691
|
)
|
|
3.5
|
%
|
|
(5,698
|
)
|
|
4.9
|
%
|
|
(2,577
|
)
|
|
4.3
|
%
|
|||
Foreign rate differential
|
(2
|
)
|
|
—
|
%
|
|
2
|
|
|
—
|
%
|
|
—
|
|
|
—
|
%
|
|||
Permanent items
|
2,537
|
|
|
(3.3
|
)%
|
|
3,687
|
|
|
(3.1
|
)%
|
|
1,525
|
|
|
(2.6
|
)%
|
|||
Provision to return adjustments
|
259
|
|
|
(0.3
|
)%
|
|
(426
|
)
|
|
0.2
|
%
|
|
64
|
|
|
(0.1
|
)%
|
|||
Effect of change in state tax rate
|
1,585
|
|
|
(2.1
|
)%
|
|
932
|
|
|
(0.8
|
)%
|
|
2
|
|
|
—
|
%
|
|||
Increase in unrecognized tax benefits
|
444
|
|
|
(0.6
|
)%
|
|
950
|
|
|
(0.8
|
)%
|
|
425
|
|
|
(0.7
|
)%
|
|||
Change in valuation allowance
|
25,385
|
|
|
(33.2
|
)%
|
|
42,636
|
|
|
(36.3
|
)%
|
|
22,070
|
|
|
(37.2
|
)%
|
|||
Net benefit
|
$
|
—
|
|
|
—
|
%
|
|
$
|
—
|
|
|
—
|
%
|
|
$
|
—
|
|
|
—
|
%
|
|
December 31,
|
||||||
|
2016
|
|
2015
|
||||
Deferred tax assets:
|
|
|
|
|
|
||
Domestic net operating loss carryforwards
|
$
|
114,111
|
|
|
$
|
93,923
|
|
Foreign net operating loss carryforwards
|
—
|
|
|
2
|
|
||
Research and development expenses
|
813
|
|
|
1,289
|
|
||
Capitalized Section 174 expenses
|
48
|
|
|
51
|
|
||
Research and development credits
|
10,907
|
|
|
8,889
|
|
||
Accrued bonuses
|
1,006
|
|
|
822
|
|
||
Share-based compensation
|
7,214
|
|
|
3,671
|
|
||
Other
|
460
|
|
|
604
|
|
||
Total gross deferred tax assets
|
134,559
|
|
|
109,251
|
|
||
Valuation allowance
|
(134,496
|
)
|
|
(109,111
|
)
|
||
Total deferred tax assets
|
63
|
|
|
140
|
|
||
Deferred tax liabilities:
|
|
|
|
|
|
||
Other
|
(63
|
)
|
|
(140
|
)
|
||
Total deferred tax liabilities
|
(63
|
)
|
|
(140
|
)
|
||
Total deferred tax assets and liabilities, net
|
$
|
—
|
|
|
$
|
—
|
|
Balance at December 31, 2014
|
$
|
1,006
|
|
Increases related to 2015
|
940
|
|
|
Increases related to prior periods
|
10
|
|
|
Balance at December 31, 2015
|
1,956
|
|
|
Increases related to 2016
|
444
|
|
|
Increases related to prior periods
|
—
|
|
|
Balance at December 31, 2016
|
$
|
2,400
|
|
|
2016 Quarters
|
||||||||||||||
|
Fourth
|
|
Third
|
|
Second
|
|
First
|
||||||||
Total revenues
|
$
|
1,980
|
|
|
$
|
653
|
|
|
$
|
1,841
|
|
|
$
|
1,228
|
|
Operating loss
|
(15,373
|
)
|
|
(17,422
|
)
|
|
(18,525
|
)
|
|
(26,632
|
)
|
||||
Net loss
|
(14,957
|
)
|
|
(17,025
|
)
|
|
(18,148
|
)
|
|
(26,260
|
)
|
||||
Net loss per share, basic and diluted
|
$
|
(0.32
|
)
|
|
$
|
(0.37
|
)
|
|
$
|
(0.39
|
)
|
|
$
|
(0.57
|
)
|
Weighted-average shares outstanding, basic and diluted
|
46,431,809
|
|
|
46,236,749
|
|
|
46,214,086
|
|
|
46,184,134
|
|
|
2015 Quarters
|
||||||||||||||
|
Fourth
|
|
Third
|
|
Second
|
|
First
|
||||||||
Total revenues
|
$
|
3,110
|
|
|
$
|
2,271
|
|
|
$
|
4,143
|
|
|
$
|
1,238
|
|
Operating loss
|
(38,223
|
)
|
|
(32,748
|
)
|
|
(24,951
|
)
|
|
(22,329
|
)
|
||||
Net loss
|
(37,842
|
)
|
|
(32,449
|
)
|
|
(24,815
|
)
|
|
(22,266
|
)
|
||||
Net loss per share, basic and diluted
|
$
|
(0.82
|
)
|
|
$
|
(0.70
|
)
|
|
$
|
(0.59
|
)
|
|
$
|
(0.54
|
)
|
Weighted-average shares outstanding, basic and diluted
|
46,151,384
|
|
|
46,059,112
|
|
|
42,079,716
|
|
|
41,220,989
|
|
i.
|
pertain to the maintenance of records, that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of our assets;
|
ii.
|
provide reasonable assurance that transactions are recorded as necessary to permit preparations 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 our management and directors; and
|
iii.
|
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.
|
Exhibit
Number |
|
Description of Document
|
3.1
(1)
|
|
Amended and Restated Certificate of Incorporation of the Registrant.
|
3.2
(1)
|
|
Amended and Restated Bylaws of the Registrant.
|
4.1
(1)
|
|
Form of Common Stock Certificate of the Registrant.
|
4.2
(1)
|
|
Form of Warrant to Purchase Stock issued to participants in the Registrant's Series F Preferred Stock financing dated February 7, 2011.
|
4.3
(1)
|
|
Amended and Restated Investor Rights Agreement dated February 7, 2011 by and among the Registrant and certain of its stockholders.
|
4.4
(2)
|
|
Amendment to Amended and Restated Investor Rights Agreement dated October 29, 2014 by and among the Registrant and certain of its stockholders.
|
10.1+
(1)
|
|
Form of Indemnity Agreement by and between the Registrant and its directors and officers.
|
10.2+
(1)
|
|
Chimerix, Inc. 2002 Equity Incentive Plan and Form of Stock Option Agreement, Notice of Exercise and Form of Stock Option Grant Notice thereunder.
|
10.3+
(1)
|
|
Chimerix, Inc. 2012 Equity Incentive Plan and Form of Stock Option Agreement, Notice of Exercise and Form of Stock Option Grant Notice and Form of Restricted Stock Unit Award Agreement and Form of Restricted Stock Unit Award Grant Notice thereunder.
|
10.4+
(18)
|
|
Form of Stock Option Agreement, Notice of Exercise and Form of Stock Option Grant Notice and Form of Restricted Stock Unit Award Agreement and Form of Restricted Stock Unit Award Grant Notice under Chimerix, Inc. 2013 Equity Incentive Plan.
|
10.5+
(3)
|
|
Chimerix, Inc. 2013 Equity Incentive Plan, as amended.
|
10.6+
(1)
|
|
Chimerix, Inc. 2013 Employee Stock Purchase Plan.
|
10.7+
|
|
Chimerix, Inc. Non-Employee Director Compensation Policy.
|
10.8+
(10)
|
|
Chimerix, Inc. Officer Change in Control Severance Benefit Plan, as amended.
|
10.9+
(1)
|
|
Employment Offer Letter to Timothy W. Trost dated March 16, 2011.
|
10.10+
(1)
|
|
Employment Offer Letter to M. Michelle Berrey, M.D., M.P.H. dated November 7, 2012.
|
10.11+
(8)
|
|
Employment Offer Letter to Linda M. Richardson dated December 13, 2013.
|
10.12
(4)
|
|
Employment Offer Letter to William Garrett Nichols, M.D., M.S., dated August 19, 2014.
|
10.13+
(1)
|
|
Directorship Offer Letter to Ernest Mario, Ph.D. dated January 31, 2013.
|
10.14
(5)
|
|
Directorship Offer Letter to Lisa Ricciardi dated March 27, 2014.
|
10.15+
(14)
|
|
Directorship Offer Letter to James M. Daly dated June 6, 2014.
|
10.16+
(14)
|
|
Directorship Offer Letter to Catherine L. Gilliss dated June 13, 2014.
|
10.17+
(14)
|
|
Directorship Offer Letter to Patrick Machado dated May 30, 2014.
|
10.18+
(14)
|
|
Directorship Offer Letter to Ronald C. Renaud, Jr. dated December 12, 2014.
|
10.19
(1)
|
|
Office Lease by and between the Registrant and ACP 2505 Meridian LLC dated September 1, 2007, as amended.
|
10.20
(7)
|
|
Lease Agreement by and between the Registrant and Northwood RTC LLC dated March 10, 2014.
|
10.21
(6)
|
|
Fifth Amendment to Office Lease dated July 2, 2014 by and between the Registrant and AREP Meridian I LLC.
|
10.22
(11)
|
|
Sixth Amendment to Office Lease dated April 28, 2015 by and between the Registrant and IVC Meridian TT O, LLC.
|
10.23*
(1)
|
|
Contract by and between the Registrant and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services dated February 16, 2011, as amended.
|
10.24*
(9)
|
|
Contract modification No. 14, dated May 30, 2013, to the contract by and between the Registrant and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services dated February 16, 2011, as amended.
|
10.25*
(10)
|
|
Contract modification No. 15, dated August 28, 2013, to the contract by and between the Registrant and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services dated February 16, 2011, as amended.
|
10.26*
(10)
|
|
Contract modification No. 16, dated December 10, 2013, to the contract by and between the Registrant and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services dated February 16, 2011, as amended.
|
10.27
(5)
|
|
Contract modification No. 17, dated April 14, 2014, to the contract by and between the Registrant and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services dated February 16, 2011, as amended.
|
10.28
(14)
|
|
Contract modification No. 18, dated May 6, 2014, to the contract by and between the Registrant and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services dated February 16, 2011, as amended.
|
10.29*
(6)
|
|
Contract modification No. 19, dated August 27, 2014, to the contract by and between the Registrant and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services dated February 16, 2011, as amended.
|
10.30
(6)
|
|
Contract modification No. 20, dated October 27, 2014, to the contract by and between the Registrant and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services dated February 16, 2011, as amended.
|
10.31*
(14)
|
|
Contract modification No. 21, dated November 7, 2014, to the contract by and between the Registrant and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services dated February 16, 2011, as amended.
|
10.32
(14)
|
|
Contract modification No. 22, dated December 11, 2014, to the contract by and between the Registrant and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services dated February 16, 2011, as amended.
|
10.33
(14)
|
|
Contract modification No. 23, dated December 22, 2014, to the contract by and between the Registrant and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services dated February 16, 2011, as amended.
|
10.34
(14)
|
|
Contract modification No. 24, dated February 19, 2015, to the contract by and between the Registrant and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services dated February 16, 2011, as amended.
|
10.35
(11)
|
|
Contract modification No. 25, dated March 26, 2015, to the contract by and between the Registrant and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services dated February 16, 2011, as amended.
|
10.36
(12)
|
|
Contract modification No. 26, dated June 18, 2015, to the contract by and between the Registrant and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services dated February 16, 2011, as amended.
|
10.37
(12)
|
|
Contract modification No. 27, dated July 14, 2015, to the contract by and between the Registrant and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services dated February 16, 2011, as amended.
|
10.38*
(13)
|
|
Contract modification No. 28, dated September 1, 2015, to the contract by and between the Registrant and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services dated February 16, 2011, as amended.
|
10.39*
(13)
|
|
Contract modification No. 29, dated September 11, 2015, to the contract by and between the Registrant and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services dated February 16, 2011, as amended.
|
10.40*
(15)
|
|
Contract modification No. 30, dated November 12, 2015, to the contract by and between the Registrant and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services dated February 16, 2011, as amended.
|
10.41*
(16)
|
|
Contract modification No. 31, dated April 8, 2016, to the contract by and between the Registrant and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services dated February 16, 2011, as amended.
|
+
|
|
Indicates management contract or compensatory plan.
|
|
|
|
*
|
|
Confidential treatment has been granted with respect to certain portions of this exhibit. Omitted portions have been filed separately with the SEC.
|
**
|
|
Confidential treatment has been requested with respect to certain portions of this exhibit. Omitted portions have been filed separately with the SEC.
|
(1)
|
|
Incorporated by reference to Chimerix, Inc.’s Registration Statement on Form S-1 (No. 333-187145), as amended.
|
(2)
|
|
Incorporated by reference to Chimerix, Inc.’s Current Report on Form 8-K (No. 001-35867) filed with the SEC on October 29, 2014.
|
(3)
|
|
Incorporated by reference to Chimerix, Inc.’s Current Report on Form 8-K (No. 001-35867) filed with the SEC on June 23, 2014.
|
(4)
|
|
Incorporated by reference to Chimerix, Inc.’s Current Report on Form 8-K (No. 001-35867) filed with the SEC on September 4, 2014.
|
(5)
|
|
Incorporated by reference to Chimerix, Inc.’s Quarterly Report on Form 10-Q (No. 001-35867) filed with the SEC on May 9, 2014.
|
(6)
|
|
Incorporated by reference to Chimerix, Inc.’s Quarterly Report on Form 10-Q (No. 001-35867) filed with the SEC on November 7, 2014.
|
(7)
|
|
Incorporated by reference to Chimerix, Inc.’s Current Report on Form 8-K (No. 001-35867) filed with the SEC on March 14, 2014.
|
(8)
|
|
Incorporated by reference to Chimerix, Inc.’s Current Report on Form 8-K (No. 001-35867) filed with the SEC on December 18, 2013.
|
(9)
|
|
Incorporated by reference to Chimerix, Inc.’s Quarterly Report on Form 10-Q (No. 001-35867) filed with the SEC on August 14, 2013.
|
(10)
|
|
Incorporated by reference to Chimerix, Inc.’s Annual Report on Form 10-K (No. 001-35867) filed with the SEC on March 7, 2014.
|
(11)
|
|
Incorporated by reference to Chimerix, Inc.'s Quarterly Report on Form 10-Q (No. 001-35867) filed with the SEC on May 11, 2015.
|
(12)
|
|
Incorporated by reference to Chimerix, Inc.'s Quarterly Report on Form 10-Q (No. 001-35867) filed with the SEC on August 6, 2015.
|
(13)
|
|
Incorporated by reference to Chimerix, Inc.'s Quarterly Report on Form 10-Q (No. 001-35867) filed with the SEC on November 5, 2015.
|
(14)
|
|
Incorporated by reference to Chimerix, Inc.’s Annual Report on Form 10-K (No. 001-35867) filed with the SEC on March 6, 2015.
|
(15)
|
|
Incorporated by reference to Chimerix, Inc.’s Annual Report on Form 10-K (No. 001-35867) filed with the SEC on February 29, 2016
|
(16)
|
|
Incorporated by reference to Chimerix, Inc.’s Quarterly Report on Form 10-Q (No. 001-35867) filed with the SEC on May 9, 2016.
|
(17)
|
|
Incorporated by reference to Chimerix, Inc.’s Quarterly Report on Form 10-Q (No. 001-35867) filed with the SEC on August 8, 2016.
|
(18)
|
|
Incorporated by reference to Chimerix, Inc.’s Quarterly Report on Form 10-Q (No. 001-35867) filed with the SEC on November 7, 2016.
|
|
|
|
Chimerix, Inc.
|
||
|
|
|
|
||
Date:
|
March 2, 2017
|
|
By:
|
|
/s/ M. Michelle Berrey
|
|
|
|
|
|
M. Michelle Berrey, MD, MPH
|
|
|
|
|
|
President & Chief Executive Officer
|
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
/s/ M. Michelle Berrey
|
|
President, Chief Executive Officer and Director
|
|
March 2, 2017
|
M. Michelle Berrey, MD, MPH
|
|
(Principal Executive Officer)
|
|
|
|
|
|
|
|
/s/ Timothy W. Trost
|
|
Senior Vice President, Chief Financial Officer
|
|
March 2, 2017
|
Timothy W. Trost
|
|
and Corporate Secretary
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(Principal Financial and Accounting Officer)
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/s/ Ernest Mario
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Ernest Mario, PhD
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Chairman of the Board of Directors
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March 2, 2017
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/s/ James M. Daly
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James M. Daly
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Member of the Board of Directors
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March 2, 2017
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/s/ Martha J. Demski
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Martha J. Demski
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Member of the Board of Directors
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March 2, 2017
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/s/ Catherine L. Gilliss
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Catherine L. Gilliss, PhD, RN, FAAN
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Member of the Board of Directors
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March 2, 2017
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/s/ Patrick Machado
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Patrick Machado
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Member of the Board of Directors
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March 2, 2017
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/s/ Ronald C. Renaud, Jr
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Ronald C. Renaud, Jr
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Member of the Board of Directors
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March 2, 2017
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/s/ Lisa Ricciardi
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Lisa Ricciardi
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Member of the Board of Directors
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March 2, 2017
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1.
|
Annual Board Service Retainer
:
|
CONTINUATION SHEET
|
REFERENCE NO. OF DOCUMENT BEING CONTINUED
HHSO100201100013C/0035
|
PAGE OF
|
||||||
2
|
2
|
|||||||
NAME OF OFFEROR OR CONTACTOR
CHIMERIX, INC. 1377270
|
||||||||
ITEM NO.
(A)
|
SUPPLIES/SERVICES
(B)
|
QUANTITY
(C)
|
UNIT
(D)
|
UNIT PRICE
(E)
|
AMOUNT
(F)
|
|||
|
being performed under the contract remain unchanged
.
This modification does not
exercise any unexercised Option CLINs under the contract and does not authorize any
performance of efforts under any unexercised Option CLINs
under the contract. In
addition, the total amount, scope and period of performance of all unexercised
Option CLINs under the contract remain unchanged. This modification also
confirms
that all activities under the base period of performance CLIN 0001 were completed
as
of 31 May 2013 and confirms that all activities under the Option l/CLIN 0002 period
of performance were completed as of 30 April 2015.
B. This is a no cost bilateral modification. All other terms and conditions
of
Contract Number HHSO100201100013C remain unchanged.
Period of Performance: 02/16/2011 to 06/30/2017
|
CONTINUATION SHEET
|
REFERENCE NO. OF DOCUMENT BEING CONTINUED
HHSO100201100013C/0036
|
PAGE OF
|
||||||
2
|
2
|
|||||||
NAME OF OFFEROR OR CONTACTOR
CHIMERIX, INC. 1377270
|
||||||||
ITEM NO.
(A)
|
SUPPLIES/SERVICES
(B)
|
QUANTITY
(C)
|
UNIT
(D)
|
UNIT PRICE
(E)
|
AMOUNT
(F)
|
|||
|
being performed under the contract remain unchanged
.
This modification does not
exercise any unexercised Option CLINs under the contract and does not authorize any
performance of efforts under any unexercised Option CLINs
under the contract. In
addition, the total amount, scope and period of performance of all unexercised
Option CLINs under the contract remain unchanged. This modification also
confirms
that all activities under the base period of performance CLIN 0001 were completed
as
of 31 May 2013 and confirms that all activities under the Option l/CLIN 0002 period
of performance were completed as of 30 April 2015.
B. This is a no cost bilateral modification. All other terms and conditions
of
Contract Number HHSO100201100013C remain unchanged.
Period of Performance: 02/16/2011 to 06/30/2017
|
(a)
|
First initial screening of LICENSED PRODUCTS within […***…] of Effective Date of License Agreement
|
(b)
|
Identification of initial drug candidate within […***…] of Effective Date of License Agreement
|
(c)
|
First Commercial Sale within […***…] of Effective Date of License Agreement
|
(i)
|
Calendar year 2016: US $[…***…];
|
(ii)
|
Calendar year 2017: US $[…***…];
|
(iii)
|
Calendar year 2018 and each calendar year thereafter during the TERM: US $[…***…].
|
To MICHIGAN:
|
To COMPANY:
|
The University of Michigan
Office of Technology Transfer
Wolverine Tower, Room 2071
3003 S. State Street
Ann Arbor, MI 48109-1280
|
Chimerix, Inc.
5007 Southpark Drive, Suite 200
Durham, NC 27713
Attention: President and CEO
|
Attn: File Nos. 0373pl, 0546, 0546p2, 0546.lpl, 0546.lp2, 0546pld l , 0546pld2, 0546pld3, 0546pld4, 0546pld5, 0546pld5cl, 0623c2, 623c4, 0623c2dl, 0932plcl, 1134, 1181a, 1181A-RE, 1181b, 1503, 1558, 2719
|
FOR CHIMERIX, INC.
By:
/s/ George Painter
Typed Name:
George Painter
Title:
President & CEO
Date: 05/29/06
|
FOR THE REGENTS OF THE
UNIVERSITY OF MICHIGAN
By:
/s/ Kenneth J. Nisbet
Kenneth J. Nisbet
Executive Director, UM Technology Transfer
|
THE REGENTS OF THE
UNIVERSITY OF MICHIGAN
|
CHIMERIX, INC.
|
|
|
By:
/s/ Kenneth J. Nisber
|
By:
/s/ Kenneth Moch
|
Name:
Kenneth J. Nisber
|
Name:
Kenneth Moch
|
Title:
Exec Dir, U-M Tech Transfer
|
Title:
President & CEO
|
To MICHIGAN:
|
To COMPANY:
|
The University of Michigan
Office of Technology Transfer
1600 Huron Pkwy
Building 520, 2
nd
floor
Ann Arbor, MI 48109
|
Chimerix, Inc.
2505 Meridian Parkway, Suite 100
Durham, NC 27713
Attention: President and CEO
|
Attn: File Nos. 0373p1, 0546, 0546p2,0546.1p1, 0546.1p2, 0546p1d1, 0546p1d2, 0546p1d3, 0546p1d4, 0546p1d5, 0546p1d5c1, 0623c2, 0623c4,
0623c2d1,0932p1c1, 1134, 1181a, 1181A-RE, 1181b, 1503, 1558, 2719, 7166 |
THE REGENTS OF THE
UNIVERSITY OF MICHIGAN |
CHIMERIX, INC.
|
By:
/s/ Kenneth J. Nisbet
Name:
Kenneth J. Nisbet
Title:
Assoc V.P. for Research U-M Tech Transfer
|
By:
/s/ Timothy W. Trost
Name:
Timothy W. Trost
Title:
SVP & CFO
|
(iv)
|
Calendar year 2027, and each calendar year thereafter during the TERM: US $[…***…].
|
THE REGENTS OF THE
UNIVERSITY OF MICHIGAN |
CHIMERIX, INC.
|
By:
/s/ Kenneth J. Nisbet
Name:
Kenneth J. Nisbet
Title:
Assoc V.P. for Research U-M Tech Transfer
|
By:
/s/ Timothy W. Trost
Name:
Timothy W. Trost
Title:
SVP & CFO
|
1.
|
Registration Statement (Form S-3 No. 333-195626) of Chimerix, Inc.,
|
2.
|
Registration Statement (Form S-8 No. 333-187860) pertaining to the 2002 Equity Incentive Plan, 2012 Equity Incentive Plan, 2013 Equity Incentive Plan and 2013 Employee Stock Purchase Plan of Chimerix, Inc., and
|
3.
|
Registration Statement (Form S-8 Nos. 333-194408, 333-202582 and 333-209802) pertaining to the 2013 Equity Incentive Plan and 2013 Employee Stock Purchase Plan of Chimerix, Inc.
|
|
|
/s/ Ernst & Young LLP
|
|
|
|
Raleigh, North Carolina
|
|
|
March 2, 2017
|
|
|
Date:
|
March 2, 2017
|
|
/s/ M. Michelle Berrey
|
|
|
|
M. Michelle Berrey, MD, MPH
|
|
|
|
President & Chief Executive Officer
|
Date:
|
March 2, 2017
|
|
/s/ Timothy W. Trost
|
|
|
|
Timothy W. Trost
Senior Vice President, Chief Financial Officer and Corporate Secretary
|
Date:
|
March 2, 2017
|
|
/s/ M. Michelle Berrey
|
|
|
|
M. Michelle Berrey, MD, MPH
|
|
|
|
President & Chief Executive Officer
|
Date:
|
March 2, 2017
|
|
/s/ Timothy W. Trost
|
|
|
|
Timothy W. Trost
Senior Vice President, Chief Financial Officer and Corporate Secretary
|