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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
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Accelerated filer
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Non-accelerated filer
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Smaller reporting company
x
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Emerging growth company
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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, 2018 are incorporated by reference into Part III of this report………………………………………………………
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10-K Part
III
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the initiation, cost, enrollment, 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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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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IV Formulation of Brincidofovir
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A.
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IV
Brincidofovir Multiple Ascending Dose Study in Healthy Subjects
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B.
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Ongoing Phase 2 Studies (210/211)
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cidofovir, a drug that is sold by generic manufacturers; and
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patient-specific T-cell therapies.
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letermovir (marketed under the trade name PREVYMIS), an anti-CMV drug recently approved for the prevention of CMV infections in adult HCT recipients pursuant to an exclusive worldwide license agreement between AiCuris GmbH & Co. KG and Merck & Co., Inc.;
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maribavir, an antiviral owned by Shire plc, 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; and
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patient-specific T-cell therapies directed at antigens of CMV and other dsDNA viruses.
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123 patents or patent applications that we own or have in-licensed from academic institutions, related to brincidofovir and CMX157, which represented a slight decrease over the number of patents in our patent portfolio at the end of fiscal 2017;
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This includes 87 US and foreign exclusively and jointly owned patents and 36 US and foreign applications related to brincidofovir and CMX157. Granted European patents are counted as one patent and have been validated throughout Europe;
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19 jointly-owned patents or patent applications related to our agreement with the UM regarding our proprietary Chemical Library; and
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One international patent application owned exclusively by Chimerix directed to a morphic form of a compound from the Chemical Library.
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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 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 AdV infection;
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advance the development of an IV formulation of brincidofovir;
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continue the development of brincidofovir for the prevention or treatment of CMV, AdV, BK virus, and other viral indications in 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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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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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;
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obtaining, maintaining, enforcing and defending intellectual property rights and claims; and
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establishing distribution channels in Europe and U.S.
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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 of Investigational New Drug applications or 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, or failure to obtain, required IRB or ethics committee (EC) approvals covering 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 declining to participate or 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 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 the Federal Civil Monetary Penalties Act, including the Federal Civil False Claims Act (False Claims Act) which permit private individuals to bring a civil action on behalf of the federal government to enforce certain of these laws thought 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 their 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, healthcare clearinghouses and certain healthcare providers, as well as their business associates;
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the General Data Protection Regulation (GDPR), which impose obligations on companies in relation to the handling of personal data of individuals within the EU, along with related national legislation;
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mandated physician payments reporting laws and/or requirements throughout global jurisdictions, including EU member states, in which we conduct research and development and/or other business activities;
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the 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, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively, the ACA), and its implementing regulations, which requires manufacturers of drugs, devices, biologicals and medical supplies to report to the Centers for Medicare & Medicaid Services (CMS) 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; state and local laws that require the registration of pharmaceutical sales representatives; 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; and state laws governing the privacy and security of health information, many of which differ from each other in significant ways and often are not preempted by HIPAA.
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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, efficacy and safety of alternative treatments;
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price and cost-effectiveness;
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effectiveness of our or any future collaborators’ or competitor’s 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 and adequate 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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differing payer reimbursement regimes, governmental payers or patient self-pay systems and price controls;
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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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cidofovir, a drug that is sold by 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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Prevymis® (letermovir), an anti-CMV drug marketed by Merck & Co., Inc.
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maribavir (SHP620) from Shire for CMV infections in transplant recipients; 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;
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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
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negotiate competitive pricing and reimbursement with third-party payers.
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our research methodology or that of our collaboration partners may be unsuccessful in identifying potential product candidates;
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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
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our collaboration partners may change their development profiles for potential product candidates or abandon a therapeutic area.
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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;
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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;
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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;
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cancel, terminate or suspend our BARDA contract based on violations or suspected violations of laws or regulations;
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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;
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reduce the scope and value of our BARDA contract;
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decline to exercise an option to continue the BARDA contract;
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direct the course of a development program in a manner not chosen by the government contractor;
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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;
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take actions that result in a longer development timeline than expected; and
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change certain terms and conditions in our BARDA contract.
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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;
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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;
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export and import control laws and regulations; and
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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.
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termination of contracts;
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forfeiture of profits;
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suspension of payments;
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fines; and
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suspension or prohibition from conducting business with the U.S. government.
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impairment of our business reputation and significant negative media attention;
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withdrawal of participants from our clinical studies;
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significant costs to defend the related litigation and related litigation;
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•
|
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 and price controls;
|
•
|
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 we operate in, 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, 2018
|
||||||
|
High
|
|
Low
|
||||
First Quarter
|
$
|
5.94
|
|
|
$
|
4.58
|
|
Second Quarter
|
$
|
5.22
|
|
|
$
|
4.35
|
|
Third Quarter
|
$
|
5.04
|
|
|
$
|
3.57
|
|
Fourth Quarter
|
$
|
4.00
|
|
|
$
|
2.08
|
|
|
|
|
|
||||
|
Year Ended December 31, 2017
|
||||||
|
High
|
|
Low
|
||||
First Quarter
|
$
|
6.64
|
|
|
$
|
4.33
|
|
Second Quarter
|
$
|
6.57
|
|
|
$
|
4.28
|
|
Third Quarter
|
$
|
5.60
|
|
|
$
|
4.30
|
|
Fourth Quarter
|
$
|
5.54
|
|
|
$
|
4.17
|
|
|
Years Ended December 31,
|
||||||||||||||||||
Consolidated Statement of Operations and Comprehensive Loss Data
|
2018
|
|
2017
|
|
2016
|
|
2015
|
|
2014
|
||||||||||
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Contract revenue
|
$
|
7,216
|
|
|
$
|
4,494
|
|
|
$
|
5,702
|
|
|
$
|
9,214
|
|
|
$
|
4,040
|
|
Collaboration and licensing revenue
|
—
|
|
|
—
|
|
|
—
|
|
|
1,548
|
|
|
—
|
|
|||||
Total revenues
|
7,216
|
|
|
4,494
|
|
|
5,702
|
|
|
10,762
|
|
|
4,040
|
|
|||||
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Research and development
|
55,239
|
|
|
49,448
|
|
|
58,647
|
|
|
97,717
|
|
|
45,379
|
|
|||||
General and administrative
|
23,582
|
|
|
27,148
|
|
|
25,007
|
|
|
31,296
|
|
|
17,527
|
|
|||||
Total operating expenses
|
78,821
|
|
|
76,596
|
|
|
83,654
|
|
|
129,013
|
|
|
62,906
|
|
|||||
Loss from operations
|
(71,605
|
)
|
|
(72,102
|
)
|
|
(77,952
|
)
|
|
(118,251
|
)
|
|
(58,866
|
)
|
|||||
Other (expense) income:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Unrealized loss on equity investment
|
(348
|
)
|
|
(1,160
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Interest income (expense) and other, net
|
2,479
|
|
|
2,278
|
|
|
1,562
|
|
|
879
|
|
|
(446
|
)
|
|||||
Net loss
|
$
|
(69,474
|
)
|
|
$
|
(70,984
|
)
|
|
$
|
(76,390
|
)
|
|
$
|
(117,372
|
)
|
|
$
|
(59,312
|
)
|
Net loss per share, basic and diluted
|
$
|
(1.43
|
)
|
|
$
|
(1.51
|
)
|
|
$
|
(1.65
|
)
|
|
$
|
(2.67
|
)
|
|
$
|
(1.80
|
)
|
Weighted-average shares outstanding, basic and diluted
|
48,593,435
|
|
|
46,963,430
|
|
|
46,267,064
|
|
|
43,878,326
|
|
|
33,003,714
|
|
|
Years Ended December 31,
|
||||||||||||||||||
Consolidated Balance Sheet Data
|
2018
|
|
2017
|
|
2016
|
|
2015
|
|
2014
|
||||||||||
Cash and cash equivalents
|
$
|
81,106
|
|
|
$
|
18,548
|
|
|
$
|
51,463
|
|
|
$
|
20,605
|
|
|
$
|
128,462
|
|
Short-term investments, available-for-sale (1)
|
105,424
|
|
|
132,972
|
|
|
180,558
|
|
|
199,729
|
|
|
106,114
|
|
|||||
Working capital
|
176,492
|
|
|
143,337
|
|
|
226,360
|
|
|
208,658
|
|
|
220,390
|
|
|||||
Long-term investments (1)
|
—
|
|
|
76,731
|
|
|
47,407
|
|
|
124,040
|
|
|
52,973
|
|
|||||
Total assets
|
190,714
|
|
|
235,230
|
|
|
286,770
|
|
|
355,992
|
|
|
291,878
|
|
|||||
Loan payable, net, current portion (2)
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
4,296
|
|
|||||
Accumulated deficit
|
(556,262
|
)
|
|
(486,788
|
)
|
|
(415,804
|
)
|
|
(339,414
|
)
|
|
(222,042
|
)
|
|||||
Total stockholders’ equity (deficit)
|
$
|
177,604
|
|
|
$
|
221,810
|
|
|
$
|
276,224
|
|
|
$
|
335,459
|
|
|
$
|
274,636
|
|
(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.
|
•
|
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, restricted stock unit (RSU) 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,
|
||||||||||
|
2018
|
|
2017
|
|
2016
|
||||||
Direct research and development expenses
|
$
|
31,325
|
|
|
$
|
24,734
|
|
|
$
|
31,415
|
|
Research and development personnel costs - excluding stock-based compensation
|
13,488
|
|
|
13,490
|
|
|
15,035
|
|
|||
Research and development personnel costs - stock-based compensation
|
5,343
|
|
|
7,047
|
|
|
7,137
|
|
|||
Indirect research and development expenses
|
5,083
|
|
|
4,177
|
|
|
5,060
|
|
|||
Total research and development expenses
|
$
|
55,239
|
|
|
$
|
49,448
|
|
|
$
|
58,647
|
|
•
|
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,
|
||||||||||
|
2018
|
|
2017
|
|
2016
|
||||||
Income Statement Classification:
|
|
|
|
|
|
||||||
Research and development expense
|
$
|
5,343
|
|
|
$
|
7,047
|
|
|
$
|
7,137
|
|
General and administrative expense
|
7,731
|
|
|
9,063
|
|
|
9,086
|
|
|||
Total stock-based compensation expense
|
$
|
13,074
|
|
|
$
|
16,110
|
|
|
$
|
16,223
|
|
•
|
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,
|
||||||||||
|
2018
|
|
2017
|
|
2016
|
||||||
Expected volatility
|
85.83
|
%
|
|
85.51
|
%
|
|
85.16
|
%
|
|||
Expected term (in years)
|
5.9
|
|
|
5.9
|
|
|
6.0
|
|
|||
Weighted-average risk-free interest rate
|
2.52
|
%
|
|
2.02
|
%
|
|
1.70
|
%
|
|||
Expected dividend yield
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|||
Weighted-average fair value per option
|
$
|
3.43
|
|
|
$
|
3.71
|
|
|
$
|
5.62
|
|
|
Years Ended December 31,
|
||||||||||
|
2018
|
|
2017
|
|
2016
|
||||||
Expected volatility
|
44.01
|
%
|
|
77.18
|
%
|
|
111.57
|
%
|
|||
Expected term (in years)
|
1.23
|
|
|
0.97
|
|
|
1.37
|
|
|||
Weighted-average risk-free interest rate
|
2.56
|
%
|
|
0.99
|
%
|
|
0.75
|
%
|
|||
Expected dividend yield
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|||
Weighted-average option value per share
|
$
|
1.36
|
|
|
$
|
2.65
|
|
|
$
|
3.20
|
|
|
Years Ended December 31,
|
|
Dollar Change
|
|
% Change
|
|||||||||
|
2018
|
|
2017
|
|
Increase/(Decrease)
|
|||||||||
Contract revenue
|
$
|
7,216
|
|
|
$
|
4,494
|
|
|
$
|
2,722
|
|
|
60.6
|
%
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|||
Research and development
|
55,239
|
|
|
49,448
|
|
|
5,791
|
|
|
11.7
|
%
|
|||
General and administrative
|
23,582
|
|
|
27,148
|
|
|
(3,566
|
)
|
|
(13.1
|
)%
|
|||
Total operating expenses
|
78,821
|
|
|
76,596
|
|
|
2,225
|
|
|
2.9
|
%
|
|||
Loss from operations
|
(71,605
|
)
|
|
(72,102
|
)
|
|
497
|
|
|
(0.7
|
)%
|
|||
Other (expense) income:
|
|
|
|
|
|
|
|
|
|
|||||
Unrealized loss on equity investment
|
(348
|
)
|
|
(1,160
|
)
|
|
812
|
|
|
(70.0
|
)%
|
|||
Interest income and other, net
|
2,479
|
|
|
2,278
|
|
|
201
|
|
|
8.8
|
%
|
|||
Net loss
|
$
|
(69,474
|
)
|
|
$
|
(70,984
|
)
|
|
$
|
1,510
|
|
|
(2.1
|
)%
|
•
|
an increase in oral brincidofovir clinical expenses of $3.2 million, which is comprised primarily of a $2.7 million increase related to the ongoing AdAPT clinical study and a $1.5 million increase of supporting bioequivalent and registry studies, primarily offset by a decrease of $1.0 million related to the completion of our AdVance study;
|
•
|
an increase of $2.7 million in oral brincidofovir smallpox program expenses which primarily includes reimbursable BARDA contract expense;
|
•
|
an increase of $1.7 million of supporting research and development expenses;
|
•
|
an increase of $0.8 million related to IV brincidofovir development;
|
•
|
a decrease of $1.5 million related to compensation expense; and
|
•
|
a decrease of $1.3 million of development costs related to CMX521.
|
•
|
a decrease of $2.3 million related to compensation expense;
|
•
|
a decrease of $1.0 million in costs related to an indemnification claim settled in 2018; and
|
•
|
a decrease of $0.3 million in global commercial readiness costs.
|
|
Years Ended December 31,
|
|
Dollar Change
|
|
% Change
|
|||||||||
|
2017
|
|
2016
|
|
Increase/(Decrease)
|
|||||||||
Contract revenue
|
$
|
4,494
|
|
|
$
|
5,702
|
|
|
$
|
(1,208
|
)
|
|
(21.2
|
)%
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|||
Research and development
|
49,448
|
|
|
58,647
|
|
|
(9,199
|
)
|
|
(15.7
|
)%
|
|||
General and administrative
|
27,148
|
|
|
25,007
|
|
|
2,141
|
|
|
8.6
|
%
|
|||
Total operating expenses
|
76,596
|
|
|
83,654
|
|
|
(7,058
|
)
|
|
(8.4
|
)%
|
|||
Loss from operations
|
(72,102
|
)
|
|
(77,952
|
)
|
|
5,850
|
|
|
(7.5
|
)%
|
|||
Other (expense) income:
|
|
|
|
|
|
|
|
|
|
|
|
|||
Unrealized loss on equity investment
|
(1,160
|
)
|
|
—
|
|
|
(1,160
|
)
|
|
*
|
|
|||
Interest income
|
2,278
|
|
|
1,562
|
|
|
716
|
|
|
45.8
|
%
|
|||
Net loss
|
$
|
(70,984
|
)
|
|
$
|
(76,390
|
)
|
|
$
|
5,406
|
|
|
(7.1
|
)%
|
•
|
a decrease in oral brincidofovir clinical expenses of $6.2 million, which is comprised primarily of an $8.7 million decrease related to the completion of our Phase 3 SUPPRESS and AdVise trials and the closeout of our SUSTAIN and SURPASS clinical trials, and a $0.6 million decrease in our expanded access programs, primarily offset by an increase of $1.8 million related to start-up activities for our AdAPT study and an increase of $1.2 million related to conduct of the AdVance study;
|
•
|
a decrease of $1.4 million in oral brincidofovir drug manufacturing costs;
|
•
|
a decrease of $1.9 million related to compensation expense;
|
•
|
a decrease of $0.9 million related to reimbursable BARDA contract expenses; and
|
•
|
a decrease of $0.8 million in supporting research and development expenses; offset by
|
•
|
an increase of approximately $2.4 million mainly related to our development of an IV formulation of brincidofovir, development of CMX521, our clinical candidate for norovirus, and other early stage compounds.
|
•
|
an increase of $2.0 million in global commercial readiness costs;
|
•
|
an increase of $1.0 million in costs related to an indemnification claim; offset by
|
•
|
a decrease of $0.6 million related to compensation expense.
|
|
Years Ended December 31,
|
||||||||||
Cash sources and uses:
|
2018
|
|
2017
|
|
2016
|
||||||
Net cash used in operating activities
|
$
|
(53,725
|
)
|
|
$
|
(50,125
|
)
|
|
$
|
(63,815
|
)
|
Net cash provided by investing activities
|
105,095
|
|
|
16,431
|
|
|
94,065
|
|
|||
Net cash provided by financing activities
|
11,188
|
|
|
779
|
|
|
608
|
|
|||
Net increase (decrease) in cash and cash equivalents
|
$
|
62,558
|
|
|
$
|
(32,915
|
)
|
|
$
|
30,858
|
|
•
|
the willingness of the FDA and/or foreign regulators to accept the results from our AdAPT study, 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 AdV 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)
|
$
|
1,818
|
|
|
$
|
786
|
|
|
$
|
1,032
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Total
|
$
|
1,818
|
|
|
$
|
786
|
|
|
$
|
1,032
|
|
|
$
|
—
|
|
|
$
|
—
|
|
(1)
|
Consists of our corporate headquarters lease encompassing
24,862
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 July 2021 and August 2021, respectively.
|
|
Page
|
Reports of Independent Registered Public Accounting Firm
|
|
Consolidated Balance Sheets as of December 31, 2018 and 2017
|
|
Consolidated Statements of Operations and Comprehensive Loss for the Years Ended December 31, 2018, 2017 and 2016
|
|
Consolidated Statements of Stockholders’ Equity (Deficit) for the Years Ended December 31, 2018, 2017 and 2016
|
|
Consolidated Statements of Cash Flows for the Years Ended December 31, 2018, 2017 and 2016
|
|
Notes to Consolidated Financial Statements
|
|
/s/ Ernst & Young LLP
|
|
/s/ Ernst & Young LLP
|
|
Years Ended December 31,
|
||||||||||
|
2018
|
|
2017
|
|
2016
|
||||||
Contract revenue
|
$
|
7,216
|
|
|
$
|
4,494
|
|
|
$
|
5,702
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|||
Research and development
|
55,239
|
|
|
49,448
|
|
|
58,647
|
|
|||
General and administrative
|
23,582
|
|
|
27,148
|
|
|
25,007
|
|
|||
Total operating expenses
|
78,821
|
|
|
76,596
|
|
|
83,654
|
|
|||
Loss from operations
|
(71,605
|
)
|
|
(72,102
|
)
|
|
(77,952
|
)
|
|||
Other (expense) income:
|
|
|
|
|
|
|
|
|
|||
Unrealized loss on equity investment
|
(348
|
)
|
|
(1,160
|
)
|
|
—
|
|
|||
Interest income and other, net
|
2,479
|
|
|
2,278
|
|
|
1,562
|
|
|||
Net loss
|
(69,474
|
)
|
|
(70,984
|
)
|
|
(76,390
|
)
|
|||
Other comprehensive loss:
|
|
|
|
|
|
|
|
|
|||
Unrealized gain (loss) on investments, net
|
871
|
|
|
(523
|
)
|
|
324
|
|
|||
Comprehensive loss
|
$
|
(68,603
|
)
|
|
$
|
(71,507
|
)
|
|
$
|
(76,066
|
)
|
Per share information:
|
|
|
|
|
|
|
|
|
|||
Net loss, basic and diluted
|
$
|
(1.43
|
)
|
|
$
|
(1.51
|
)
|
|
$
|
(1.65
|
)
|
Weighted-average shares outstanding, basic and diluted
|
48,593,435
|
|
|
46,963,430
|
|
|
46,267,064
|
|
|
Common
Stock |
|
Additional
Paid-in Capital |
|
Accumulated Other
Comprehensive Gain (Loss) |
|
Accumulated
Deficit |
|
Total
Stockholders’ Equity (Deficit) |
||||||||||
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
|
|
|||||
Share-based compensation
|
1
|
|
|
16,109
|
|
|
—
|
|
|
—
|
|
|
16,110
|
|
|||||
Exercise of stock options
|
—
|
|
|
121
|
|
|
—
|
|
|
—
|
|
|
121
|
|
|||||
Employee stock purchase plan purchases
|
—
|
|
|
712
|
|
|
—
|
|
|
—
|
|
|
712
|
|
|||||
University of Michigan stock issuance
|
—
|
|
|
150
|
|
|
—
|
|
|
—
|
|
|
150
|
|
|||||
Comprehensive loss:
|
|
|
|
|
|
|
|
|
|
||||||||||
Unrealized loss on investments, net
|
—
|
|
|
—
|
|
|
(523
|
)
|
|
—
|
|
|
(523
|
)
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(70,984
|
)
|
|
(70,984
|
)
|
|||||
Total comprehensive loss
|
|
|
|
|
|
|
|
|
(71,507
|
)
|
|||||||||
Balance, December 31, 2017
|
47
|
|
|
709,514
|
|
|
(963
|
)
|
|
(486,788
|
)
|
|
221,810
|
|
|||||
Share-based compensation
|
1
|
|
|
13,073
|
|
|
—
|
|
|
—
|
|
|
13,074
|
|
|||||
Exercise of stock options
|
—
|
|
|
115
|
|
|
—
|
|
|
—
|
|
|
115
|
|
|||||
Employee stock purchase plan purchases
|
—
|
|
|
608
|
|
|
—
|
|
|
—
|
|
|
608
|
|
|||||
Issuance of common stock, net of issuance costs
|
3
|
|
|
10,597
|
|
|
—
|
|
|
—
|
|
|
10,600
|
|
|||||
Comprehensive loss:
|
|
|
|
|
|
|
|
|
|
||||||||||
Unrealized gain on investments, net
|
—
|
|
|
—
|
|
|
871
|
|
|
—
|
|
|
871
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(69,474
|
)
|
|
(69,474
|
)
|
|||||
Total comprehensive loss
|
|
|
|
|
|
|
|
|
(68,603
|
)
|
|||||||||
Balance, December 31, 2018
|
$
|
51
|
|
|
$
|
733,907
|
|
|
$
|
(92
|
)
|
|
$
|
(556,262
|
)
|
|
$
|
177,604
|
|
|
Years Ended December 31,
|
||||||||||
|
2018
|
|
2017
|
|
2016
|
||||||
Cash flows from operating activities:
|
|
|
|
|
|
|
|
|
|||
Net loss
|
$
|
(69,474
|
)
|
|
$
|
(70,984
|
)
|
|
$
|
(76,390
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
|||
Depreciation of property and equipment
|
860
|
|
|
1,091
|
|
|
1,063
|
|
|||
Amortization of discount/premium on investments
|
(852
|
)
|
|
(5
|
)
|
|
1,223
|
|
|||
Share-based compensation
|
13,074
|
|
|
16,110
|
|
|
16,223
|
|
|||
Loss on sale of investments
|
378
|
|
|
—
|
|
|
—
|
|
|||
Unrealized loss on equity investment
|
348
|
|
|
1,160
|
|
|
—
|
|
|||
Amortization of lease-related obligations
|
(59
|
)
|
|
(319
|
)
|
|
132
|
|
|||
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|||
Accounts receivable
|
1,352
|
|
|
(83
|
)
|
|
861
|
|
|||
Prepaid expenses and other assets
|
643
|
|
|
(168
|
)
|
|
3,215
|
|
|||
Accounts payable and accrued liabilities
|
5
|
|
|
3,073
|
|
|
(10,142
|
)
|
|||
Net cash used in operating activities
|
(53,725
|
)
|
|
(50,125
|
)
|
|
(63,815
|
)
|
|||
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
|||
Purchases of property and equipment
|
(181
|
)
|
|
(151
|
)
|
|
(841
|
)
|
|||
Purchases of short-term investments
|
(125,611
|
)
|
|
—
|
|
|
(23,992
|
)
|
|||
Purchases of long-term investments
|
(6,031
|
)
|
|
(162,613
|
)
|
|
(79,381
|
)
|
|||
Proceeds from sales of short-term investments
|
111,178
|
|
|
13,500
|
|
|
—
|
|
|||
Proceeds from maturities of short-term investments
|
125,740
|
|
|
165,695
|
|
|
198,279
|
|
|||
Net cash provided by investing activities
|
105,095
|
|
|
16,431
|
|
|
94,065
|
|
|||
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
|||
Proceeds from exercise of stock options
|
115
|
|
|
121
|
|
|
168
|
|
|||
Proceeds from employee stock purchase plan
|
608
|
|
|
712
|
|
|
440
|
|
|||
Proceeds from issuance of common stock, net of commissions
|
10,867
|
|
|
—
|
|
|
—
|
|
|||
Payments of deferred offering costs
|
(402
|
)
|
|
(54
|
)
|
|
—
|
|
|||
Net cash provided by financing activities
|
11,188
|
|
|
779
|
|
|
608
|
|
|||
Net increase (decrease) in cash and cash equivalents
|
62,558
|
|
|
(32,915
|
)
|
|
30,858
|
|
|||
Cash and cash equivalents:
|
|
|
|
|
|
|
|
|
|||
Beginning of period
|
18,548
|
|
|
51,463
|
|
|
20,605
|
|
|||
End of period
|
$
|
81,106
|
|
|
$
|
18,548
|
|
|
$
|
51,463
|
|
Supplemental disclosure of cash flow information
|
|
|
|
|
|
|
|
|
|||
Non-cash addition to deferred offering costs
|
$
|
22
|
|
|
$
|
276
|
|
|
$
|
—
|
|
•
|
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, 2018
|
|
|
||||||||||
|
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
|
$
|
30,726
|
|
|
$
|
30,726
|
|
|
$
|
—
|
|
|
$
|
—
|
|
U.S. Treasury securities
|
11,482
|
|
|
11,482
|
|
|
—
|
|
|
—
|
|
||||
Commercial paper
|
29,677
|
|
|
—
|
|
|
29,677
|
|
|
—
|
|
||||
Corporate bonds
|
4,008
|
|
|
—
|
|
|
4,008
|
|
|
—
|
|
||||
Total cash equivalents
|
75,893
|
|
|
42,208
|
|
|
33,685
|
|
|
—
|
|
||||
Short-term investments
|
|
|
|
|
|
|
|
||||||||
U.S. Treasury securities
|
12,589
|
|
|
12,589
|
|
|
—
|
|
|
—
|
|
||||
Common stock of U.S. corporation
|
38
|
|
|
38
|
|
|
—
|
|
|
—
|
|
||||
Commercial paper
|
60,114
|
|
|
—
|
|
|
60,114
|
|
|
—
|
|
||||
Corporate bonds
|
32,683
|
|
|
—
|
|
|
32,683
|
|
|
—
|
|
||||
Total short-term investments
|
105,424
|
|
|
12,627
|
|
|
92,797
|
|
|
—
|
|
||||
Total assets
|
$
|
181,317
|
|
|
$
|
54,835
|
|
|
$
|
126,482
|
|
|
$
|
—
|
|
|
|
|
Fair Value Measurements
|
|
|
||||||||||
|
|
|
December 31, 2017
|
|
|
||||||||||
|
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
|
$
|
10,816
|
|
|
$
|
10,816
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Commercial paper
|
3,995
|
|
|
—
|
|
|
3,995
|
|
|
—
|
|
||||
Total cash equivalents
|
14,811
|
|
|
10,816
|
|
|
3,995
|
|
|
—
|
|
||||
Short-term investments
|
|
|
|
|
|
|
|
||||||||
U.S. Treasury securities
|
132,586
|
|
|
132,586
|
|
|
—
|
|
|
—
|
|
||||
Common stock of U.S. corporation
|
386
|
|
|
386
|
|
|
—
|
|
|
—
|
|
||||
Total short-term investments
|
132,972
|
|
|
132,972
|
|
|
—
|
|
|
—
|
|
||||
Long-term investments
|
|
|
|
|
|
|
|
||||||||
U.S. Treasury securities
|
76,731
|
|
|
76,731
|
|
|
—
|
|
|
—
|
|
||||
Total long-term investments
|
76,731
|
|
|
76,731
|
|
|
—
|
|
|
—
|
|
||||
Total assets
|
$
|
224,514
|
|
|
$
|
220,519
|
|
|
$
|
3,995
|
|
|
$
|
—
|
|
|
December 31,
|
||||||
|
2018
|
|
2017
|
||||
Prepaid research and development expenses
|
$
|
1,071
|
|
|
$
|
1,138
|
|
Interest receivable
|
259
|
|
|
601
|
|
||
Prepaid insurance
|
382
|
|
|
481
|
|
||
Other prepaid expenses and current assets
|
886
|
|
|
1,111
|
|
||
Total prepaid expenses and other current assets
|
$
|
2,598
|
|
|
$
|
3,331
|
|
|
December 31,
|
||||||
|
2018
|
|
2017
|
||||
Accrued compensation
|
$
|
2,469
|
|
|
$
|
3,678
|
|
Accrued research and development expenses
|
4,525
|
|
|
3,384
|
|
||
Accrued indemnification claim
|
—
|
|
|
1,000
|
|
||
Other accrued liabilities
|
1,281
|
|
|
1,322
|
|
||
Total accrued liabilities
|
$
|
8,275
|
|
|
$
|
9,384
|
|
|
December 31, 2018
|
||||||||||||||
|
Amortized Cost
|
|
Gross Unrealized
Gains |
|
Gross Unrealized
Losses |
|
Estimated
Fair Value |
||||||||
Corporate bonds
|
$
|
32,724
|
|
|
$
|
—
|
|
|
$
|
(41
|
)
|
|
$
|
32,683
|
|
Commercial paper
|
60,159
|
|
|
—
|
|
|
(45
|
)
|
|
60,114
|
|
||||
U.S. Treasury securities
|
12,592
|
|
|
—
|
|
|
(3
|
)
|
|
12,589
|
|
||||
Total investments
|
$
|
105,475
|
|
|
$
|
—
|
|
|
$
|
(89
|
)
|
|
$
|
105,386
|
|
|
December 31, 2017
|
||||||||||||||
|
Amortized Cost
|
|
Gross Unrealized
Gains |
|
Gross Unrealized
Losses |
|
Estimated
Fair Value |
||||||||
U.S. Treasury securities
|
$
|
210,280
|
|
|
$
|
—
|
|
|
$
|
(963
|
)
|
|
$
|
209,317
|
|
Total investments
|
$
|
210,280
|
|
|
$
|
—
|
|
|
$
|
(963
|
)
|
|
$
|
209,317
|
|
|
|
December 31, 2018
|
||||||||||||||||||||||
|
|
Less than 12 Months
|
|
Greater than 12 Months
|
|
Total
|
||||||||||||||||||
|
|
Fair Value
|
|
Unrealized Loss
|
|
Fair Value
|
|
Unrealized Loss
|
|
Fair Value
|
|
Unrealized Loss
|
||||||||||||
Corporate bonds
|
|
$
|
32,683
|
|
|
$
|
(41
|
)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
32,683
|
|
|
$
|
(41
|
)
|
Commercial paper
|
|
60,114
|
|
|
(45
|
)
|
|
—
|
|
|
—
|
|
|
60,114
|
|
|
(45
|
)
|
||||||
U.S. Treasury securities
|
|
12,589
|
|
|
(3
|
)
|
|
—
|
|
|
—
|
|
|
12,589
|
|
|
(3
|
)
|
||||||
Total
|
|
$
|
105,386
|
|
|
$
|
(89
|
)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
105,386
|
|
|
$
|
(89
|
)
|
Number of securities with unrealized losses
|
|
|
|
36
|
|
|
|
|
—
|
|
|
|
|
36
|
|
|
|
December 31, 2017
|
||||||||||||||||||||||
|
|
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
|
|
$
|
170,390
|
|
|
$
|
(871
|
)
|
|
$
|
38,927
|
|
|
$
|
(92
|
)
|
|
$
|
209,317
|
|
|
$
|
(963
|
)
|
Total
|
|
$
|
170,390
|
|
|
$
|
(871
|
)
|
|
$
|
38,927
|
|
|
$
|
(92
|
)
|
|
$
|
209,317
|
|
|
$
|
(963
|
)
|
Number of securities with unrealized losses
|
|
|
|
39
|
|
|
|
|
7
|
|
|
|
|
46
|
|
|
December 31, 2018
|
||
Maturing in one year or less
|
$
|
105,386
|
|
Total debt investments
|
$
|
105,386
|
|
Common stock of U.S. corporation
|
38
|
|
|
Total investments
|
$
|
105,424
|
|
|
December 31,
|
||||||
|
2018
|
|
2017
|
||||
Lab equipment
|
$
|
2,599
|
|
|
$
|
2,496
|
|
Leasehold improvements
|
1,550
|
|
|
1,552
|
|
||
Computer equipment
|
1,181
|
|
|
1,170
|
|
||
Office furniture and equipment
|
520
|
|
|
520
|
|
||
Property and equipment
|
5,850
|
|
|
5,738
|
|
||
Less accumulated depreciation
|
(4,640
|
)
|
|
(3,844
|
)
|
||
Property and equipment, net of accumulated depreciation
|
$
|
1,210
|
|
|
$
|
1,894
|
|
Years Ending December 31,
|
Minimum Rental Payment
|
||
2019
|
$
|
786
|
|
2020
|
797
|
|
|
2021
|
235
|
|
|
Total future minimum rental payments
|
$
|
1,818
|
|
Years Ending December 31,
|
Minimum Sublease Rentals
|
||
2019
|
$
|
78
|
|
2020
|
81
|
|
|
2021
|
14
|
|
|
Total future minimum sublease rentals
|
$
|
173
|
|
|
December 31,
|
||||
|
2018
|
|
2017
|
||
For exercise of common stock warrants
|
—
|
|
|
227,794
|
|
For exercise of outstanding common stock options
|
6,429,638
|
|
|
4,996,661
|
|
For delivery upon vesting of outstanding restricted stock units
|
656,169
|
|
|
956,299
|
|
For future equity awards under the 2013 Equity Incentive Plan
|
1,587,670
|
|
|
1,082,608
|
|
For future purchases under the 2013 Employee Stock Purchase Plan
|
2,120,290
|
|
|
1,861,472
|
|
Total shares of common stock reserved for future issuances
|
10,793,767
|
|
|
9,124,834
|
|
|
Years Ended December 31,
|
||||||||||
|
2018
|
|
2017
|
|
2016
|
||||||
Expected volatility
|
85.83
|
%
|
|
85.51
|
%
|
|
85.16
|
%
|
|||
Expected term (in years)
|
5.9
|
|
|
5.9
|
|
|
6.0
|
|
|||
Weighted-average risk-free interest rate
|
2.52
|
%
|
|
2.02
|
%
|
|
1.70
|
%
|
|||
Expected dividend yield
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|||
Weighted-average fair value per option
|
$
|
3.43
|
|
|
$
|
3.71
|
|
|
$
|
5.62
|
|
|
Number of Options
Outstanding |
|
Weighted-Average
Exercise Price |
|
Weighted-Average
Remaining Contractual Life (in Years) |
|
Total Intrinsic Value
|
||||||
Balance, December 31, 2016
|
4,342,466
|
|
|
$
|
17.81
|
|
|
8.09
|
|
|
|
||
Granted
|
928,816
|
|
|
5.17
|
|
|
—
|
|
|
|
|||
Exercised
|
(38,885
|
)
|
|
3.98
|
|
|
—
|
|
|
|
|||
Forfeited
|
(235,736
|
)
|
|
19.10
|
|
|
—
|
|
|
|
|||
Balance, December 31, 2017
|
4,996,661
|
|
|
$
|
15.51
|
|
|
7.59
|
|
|
|
||
Granted
|
2,050,995
|
|
|
4.73
|
|
|
—
|
|
|
|
|||
Exercised
|
(29,262
|
)
|
|
3.93
|
|
|
—
|
|
|
|
|||
Forfeited
|
(588,756
|
)
|
|
12.31
|
|
|
—
|
|
|
|
|||
Balance, December 31, 2018
|
6,429,638
|
|
|
$
|
12.41
|
|
|
7.37
|
|
|
$
|
39,873
|
|
Exercisable at December 31, 2018
|
4,119,234
|
|
|
$
|
15.94
|
|
|
6.75
|
|
|
$
|
39,873
|
|
Vested or expected to vest at December 31, 2018
|
6,366,085
|
|
|
$
|
12.47
|
|
|
7.36
|
|
|
$
|
39,873
|
|
|
|
Years Ended December 31,
|
||||||||||
|
|
2018
|
|
2017
|
|
2016
|
||||||
Weighted-average grant-date fair value per share of options granted
|
|
$
|
3.43
|
|
|
$
|
3.71
|
|
|
$
|
5.62
|
|
Total intrinsic value of options exercised
|
|
$
|
31
|
|
|
$
|
48
|
|
|
$
|
119
|
|
Total fair value of shares vested
|
|
$
|
11,021
|
|
|
$
|
11,786
|
|
|
$
|
13,330
|
|
|
|
Outstanding
|
|
Exercisable
|
||||||||||||
Exercise Price Range ($)
|
|
Number
|
|
Weighted-Average Remaining Contractual Life (in years)
|
|
Weighted-Average Exercise Price
|
|
Number
|
|
Weighted-Average Exercise Price
|
||||||
1.57 to 7.57
|
|
3,139,495
|
|
|
8.37
|
|
$
|
4.70
|
|
|
1,323,880
|
|
|
$
|
4.54
|
|
7.58 to 8.06
|
|
1,696,746
|
|
|
7.02
|
|
8.06
|
|
|
1,239,595
|
|
|
8.06
|
|
||
8.07 to 18.75
|
|
261,805
|
|
|
5.07
|
|
18.59
|
|
|
261,805
|
|
|
18.59
|
|
||
18.76 to 39.17
|
|
559,663
|
|
|
5.55
|
|
25.32
|
|
|
556,525
|
|
|
25.25
|
|
||
39.18 to 53.74
|
|
771,929
|
|
|
6.22
|
|
41.90
|
|
|
737,429
|
|
|
41.71
|
|
||
1.57 to 53.74
|
|
6,429,638
|
|
|
7.37
|
|
$
|
12.41
|
|
|
4,119,234
|
|
|
$
|
15.94
|
|
|
Years Ended December 31,
|
||||||||||
|
2018
|
|
2017
|
|
2016
|
||||||
Expected volatility
|
44.01
|
%
|
|
77.18
|
%
|
|
111.57
|
%
|
|||
Expected term (in years)
|
1.23
|
|
|
0.97
|
|
|
1.37
|
|
|||
Weighted-average risk-free interest rate
|
2.56
|
%
|
|
0.99
|
%
|
|
0.75
|
%
|
|||
Expected dividend yield
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|||
Weighted-average option value per share
|
$
|
1.36
|
|
|
$
|
2.65
|
|
|
$
|
3.20
|
|
|
Number of Restricted
Stock Units Outstanding |
Weighted-Average Grant-Date Fair Value
|
|||
Balance, December 31, 2017
|
956,299
|
|
$
|
5.08
|
|
Granted
|
153,375
|
|
4.42
|
|
|
Share issuance
|
(233,050
|
)
|
5.05
|
|
|
Forfeited
|
(220,455
|
)
|
5.12
|
|
|
Balance, December 31, 2018
|
656,169
|
|
$
|
4.92
|
|
|
Years Ended December 31,
|
||||||||||
|
2018
|
|
2017
|
|
2016
|
||||||
Income Statement Classification:
|
|
|
|
|
|
||||||
Research and development expense
|
$
|
5,343
|
|
|
$
|
7,047
|
|
|
$
|
7,137
|
|
General and administrative expense
|
7,731
|
|
|
9,063
|
|
|
9,086
|
|
|||
Total stock-based compensation expense
|
$
|
13,074
|
|
|
$
|
16,110
|
|
|
$
|
16,223
|
|
|
2018
|
|
2017
|
|
2016
|
|||||||||||||||
|
Amount
|
|
% of Pretax
Earnings |
|
Amount
|
|
% of Pretax
Earnings |
|
Amount
|
|
% of Pretax
Earnings |
|||||||||
Income tax benefit at statutory rate
|
$
|
(14,590
|
)
|
|
21.0
|
%
|
|
$
|
(24,134
|
)
|
|
34.0
|
%
|
|
$
|
(25,973
|
)
|
|
34.0
|
%
|
State income taxes
|
(792
|
)
|
|
1.1
|
%
|
|
(1,090
|
)
|
|
1.5
|
%
|
|
(1,544
|
)
|
|
2.0
|
%
|
|||
Research and development credits
|
(1,798
|
)
|
|
2.6
|
%
|
|
(2,039
|
)
|
|
2.9
|
%
|
|
(2,691
|
)
|
|
3.5
|
%
|
|||
Foreign rate differential
|
2
|
|
|
—
|
%
|
|
60
|
|
|
(0.1
|
)%
|
|
(2
|
)
|
|
—
|
%
|
|||
Permanent items
|
1,164
|
|
|
(1.7
|
)%
|
|
1,646
|
|
|
(2.3
|
)%
|
|
2,537
|
|
|
(3.3
|
)%
|
|||
Provision to return adjustments
|
621
|
|
|
(0.9
|
)%
|
|
1,212
|
|
|
(1.7
|
)%
|
|
259
|
|
|
(0.3
|
)%
|
|||
Effect of change in federal tax rate
|
—
|
|
|
—
|
%
|
|
57,950
|
|
|
(81.6
|
)%
|
|
—
|
|
|
—
|
%
|
|||
Effect of change in state tax rate
|
151
|
|
|
(0.2
|
)%
|
|
193
|
|
|
(0.3
|
)%
|
|
1,585
|
|
|
(2.1
|
)%
|
|||
Removal of excess tax benefit
|
—
|
|
|
—
|
%
|
|
(12,930
|
)
|
|
18.2
|
%
|
|
—
|
|
|
—
|
%
|
|||
Increase in unrecognized tax benefits
|
450
|
|
|
(0.7
|
)%
|
|
403
|
|
|
(0.6
|
)%
|
|
444
|
|
|
(0.6
|
)%
|
|||
Change in valuation allowance
|
14,792
|
|
|
(21.2
|
)%
|
|
(21,271
|
)
|
|
30.0
|
%
|
|
25,385
|
|
|
(33.2
|
)%
|
|||
Net benefit
|
$
|
—
|
|
|
—
|
%
|
|
$
|
—
|
|
|
—
|
%
|
|
$
|
—
|
|
|
—
|
%
|
|
December 31,
|
||||||
|
2018
|
|
2017
|
||||
Deferred tax assets:
|
|
|
|
|
|
||
Domestic net operating loss carryforwards
|
$
|
104,708
|
|
|
$
|
92,020
|
|
Foreign net operating loss carryforwards
|
71
|
|
|
61
|
|
||
Research and development expenses
|
1,002
|
|
|
763
|
|
||
Capitalized Section 174 expenses
|
25
|
|
|
28
|
|
||
Research and development credits
|
13,789
|
|
|
12,437
|
|
||
Accrued bonuses
|
500
|
|
|
777
|
|
||
Share-based compensation
|
7,144
|
|
|
6,156
|
|
||
Other
|
778
|
|
|
983
|
|
||
Total gross deferred tax assets
|
128,017
|
|
|
113,225
|
|
||
Valuation allowance
|
(128,017
|
)
|
|
(113,225
|
)
|
||
Total deferred tax assets
|
—
|
|
|
—
|
|
||
Deferred tax liabilities:
|
|
|
|
|
|
||
Other
|
—
|
|
|
—
|
|
||
Total deferred tax liabilities
|
—
|
|
|
—
|
|
||
Total deferred tax assets and liabilities, net
|
$
|
—
|
|
|
$
|
—
|
|
Balance at December 31, 2016
|
$
|
2,400
|
|
Increases related to 2017
|
403
|
|
|
Increases related to prior periods
|
473
|
|
|
Balance at December 31, 2017
|
3,276
|
|
|
Increases related to 2018
|
450
|
|
|
Increases related to prior periods
|
—
|
|
|
Balance at December 31, 2018
|
$
|
3,726
|
|
|
2018 Quarters
|
||||||||||||||
|
Fourth
|
|
Third
|
|
Second
|
|
First
|
||||||||
Revenue
|
$
|
4,864
|
|
|
$
|
369
|
|
|
$
|
1,193
|
|
|
$
|
790
|
|
Operating loss
|
(15,419
|
)
|
|
(16,710
|
)
|
|
(19,169
|
)
|
|
(20,307
|
)
|
||||
Net loss
|
(14,956
|
)
|
|
(16,079
|
)
|
|
(18,613
|
)
|
|
(19,826
|
)
|
||||
Net loss per share, basic and diluted
|
$
|
(0.29
|
)
|
|
$
|
(0.33
|
)
|
|
$
|
(0.39
|
)
|
|
$
|
(0.42
|
)
|
Weighted-average shares outstanding, basic and diluted
|
50,722,655
|
|
|
48,172,354
|
|
|
47,811,552
|
|
|
47,637,907
|
|
|
2017 Quarters
|
||||||||||||||
|
Fourth
|
|
Third
|
|
Second
|
|
First
|
||||||||
Revenue
|
$
|
1,844
|
|
|
$
|
897
|
|
|
$
|
675
|
|
|
$
|
1,078
|
|
Operating loss
|
(18,687
|
)
|
|
(17,910
|
)
|
|
(17,245
|
)
|
|
(18,260
|
)
|
||||
Net loss
|
(19,238
|
)
|
|
(17,312
|
)
|
|
(16,680
|
)
|
|
(17,754
|
)
|
||||
Net loss per share, basic and diluted
|
$
|
(0.41
|
)
|
|
$
|
(0.37
|
)
|
|
$
|
(0.36
|
)
|
|
$
|
(0.38
|
)
|
Weighted-average shares outstanding, basic and diluted
|
47,341,271
|
|
|
47,065,756
|
|
|
46,863,753
|
|
|
46,573,394
|
|
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)
|
|
|
3.2
(1)
|
|
|
4.1
(1)
|
|
|
10.1+
(1)
|
|
|
10.2+
(1)
|
|
|
10.3+
(1)
|
|
|
10.4+
(17)
|
|
|
10.5+
(2)
|
|
|
10.6+
(1)
|
|
|
10.7+
(25)
|
|
|
10.8+
(26)
|
|
|
10.9+
(1)
|
|
|
10.10+
(1)
|
|
|
10.11+
(3)
|
|
|
10.12+
(12)
|
|
|
10.13+
(12)
|
|
|
10.14+
(12)
|
|
|
10.15+
(12)
|
|
|
10.16
(1)
|
|
|
10.17
(6)
|
|
|
10.18
(5)
|
|
|
10.19
(9)
|
|
|
10.20
(17)
|
|
|
10.21
(18)
|
|
|
10.22*
(1)
|
|
10.23*
(7)
|
|
|
10.24*
(8)
|
|
|
10.25*
(8)
|
|
|
10.26
(4)
|
|
|
10.27
(12)
|
|
|
10.28*
(5)
|
|
|
10.29
(5)
|
|
|
10.30*
(12)
|
|
|
10.31
(12)
|
|
|
10.32
(12)
|
|
|
10.33
(12)
|
|
|
10.34
(9)
|
|
|
10.35
(10)
|
|
|
10.36
(10)
|
|
|
10.37*
(11)
|
|
|
10.38*
(11)
|
|
|
10.39*
(13)
|
|
|
10.40*
(14)
|
|
|
10.41*
(14)
|
|
|
10.42*
(15)
|
|
10.43*
(16)
|
|
|
10.44
(17)
|
|
|
10.45
(17)
|
|
|
10.46
(18)
|
|
|
10.47
(19)
|
|
|
10.48
(19)
|
|
|
10.49
(19)
|
|
|
10.50
(20)
|
|
|
10.51
(20)
|
|
|
10.52
(20)
|
|
|
10.53
(20)
|
|
|
10.54
(22)
|
|
|
10.55
(22)
|
|
|
10.56*
(22)
|
|
|
10.57
(22)
|
|
|
10.58*
(22)
|
|
|
10.59*
(23)
|
|
10.60*
(24)
|
|
|
10.61*
(24)
|
|
|
10.62
(25)
|
|
|
10.63
|
|
|
10.64**
|
|
|
10.65*
(17)
|
|
|
10.66*
(1)
|
|
|
10.67
(21)
|
|
|
10.68
(22)
|
|
|
10.69
(23)
|
|
|
10.70+
|
|
|
10.71+
|
|
|
23.1
|
|
|
24.1
|
|
|
31.1
|
|
|
31.2
|
|
|
32.1
|
|
|
32.2
|
|
|
101.INS
|
|
XBRL Instance Document.
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document.
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase Document.
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase Document.
|
101.LAB
|
|
XBRL Taxonomy Extension Label Linkbase Document.
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase Document.
|
(25)
|
|
Incorporated by reference to Chimerix, Inc.’s Quarterly Report on Form 10-Q (No. 001-35867) filed with the SEC on November 8, 2018.
|
|
|
|
Chimerix, Inc.
|
||
|
|
|
|
||
Date:
|
March 5, 2019
|
|
By:
|
|
/s/ Michael A. Alrutz
|
|
|
|
|
|
Michael A. Alrutz
|
|
|
|
|
|
Principal Executive Officer
|
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
/s/ Michael A. Alrutz
|
|
Principal Executive Officer
|
|
March 5, 2019
|
Michael A. Alrutz
|
|
|
|
|
|
|
|
|
|
/s/ Timothy W. Trost
|
|
Principal Financial and Accounting Officer
|
|
March 5, 2019
|
Timothy W. Trost
|
|
|
|
|
|
|
|
|
|
/s/ Martha J. Demski
|
|
|
|
|
Martha J. Demski
|
|
Chair of the Board of Directors
|
|
March 5, 2019
|
|
|
|
|
|
/s/ James M. Daly
|
|
|
|
|
James M. Daly
|
|
Member of the Board of Directors
|
|
March 5, 2019
|
|
|
|
|
|
/s/ Catherine L. Gilliss
|
|
|
|
|
Catherine L. Gilliss, PhD, RN, FAAN
|
|
Member of the Board of Directors
|
|
March 5, 2019
|
|
|
|
|
|
/s/ Edward F. Greissing Jr.
|
|
|
|
|
Edward F. Greissing Jr.
|
|
Member of the Board of Directors
|
|
March 5, 2019
|
|
|
|
|
|
/s/ Patrick Machado
|
|
|
|
|
Patrick Machado
|
|
Member of the Board of Directors
|
|
March 5, 2019
|
|
|
|
|
|
/s/ Robert J. Meyer
|
|
|
|
|
Robert J. Meyer, MD
|
|
Member of the Board of Directors
|
|
March 5, 2019
|
|
|
|
|
|
/s/ Fred A. Middleton
|
|
|
|
|
Fred A. Middleton
|
|
Member of the Board of Directors
|
|
March 5, 2019
|
|
|
|
|
|
/s/ Ronald C. Renaud Jr.
|
|
|
|
|
Ronald C. Renaud Jr.
|
|
Member of the Board of Directors
|
|
March 5, 2019
|
CONTINUATION SHEET
|
REFERENCE NO. OF DOCUMENT BEING CONTINUED
|
PAGE OF
|
||||||
HHSO100201100013C/0054
|
2
|
2
|
||||||
NAME OF OFFEROR OR CONTRACTOR
|
||||||||
CHIMERIX, INC. 1377270
|
||||||||
ITEM NO.
|
SUPPLIES/SERVICES
|
QUANTITY
|
UNIT
|
UNIT PRICE
|
AMOUNT
|
|||
(A)
|
(B)
|
(C)
|
(D)
|
(E)
|
(F)
|
|||
|
|
|
|
|
|
|||
|
|
|
|
|
|
|||
|
|
|
|
|
|
|||
NSN 7540-01-152-8067
OPTIONAL FORM 336 (4-86)
Sponsored by GSA FAR (48 CFR) 53.110 |
AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT
|
1. CONTRACT ID CODE
|
PAGE OF PAGES
|
||||||||||
1
|
|
3
|
|
|||||||||
2. AMENDMENT/MODIFICATION NO.
0055
|
3. EFFECTIVE DATE
See Block 16C
|
4. REQUISITION/PURCHASE REQ. NO
OS232949
|
5. PROJECT NO.
(If applicable)
|
|||||||||
6. ISSUED BY
|
CODE
|
ASPR-BARDA
|
7. ADMINISTERED BY (
if other than Item 6
)
|
CODE
|
ASPR-BARDA02
|
|||||||
ASPR-BARDA
200 Independence Ave., S.W.
Room 640-G
Washington DC 20201
|
ASPR-BARDA
330 Independence Ave, SW, Rm G640
Washington DC 20201
|
|||||||||||
8. NAME AND ADDRESS OF CONTRACTOR (
No., street, county, State, and ZIP Code
)
CHIMERIX, INC. 1377270
CHIMERIX, INC. 2505 MERIDIAN P
2505 MERIDIAN PKWY STE 340
DURHAM NC 277135246
|
(x)
|
9A. AMENDMENT OF SOLICITATION NO.
|
||||||||||
9B. DATED (
SEE ITEM 11
)
|
||||||||||||
x
|
10A. MODIFICATION OF CONTRACT/ORDER NO.
HHSO100201100013C
|
|||||||||||
CODE:
1377270
|
FACILITY CODE:
|
10B. DATED (
SEE ITEM 13
)
02/16/2011
|
||||||||||
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS
|
12. ACCOUNTING AND APPROPRIATION DATA (
If Required
)
Net Increase: $2,340,571.00
See Schedule
|
|
|||||
13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS, IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14
|
|
|||||
CHECK ONE
|
A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (
Specify authority
) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT
ORDER NO IN ITEM 10A. |
|||||
|
B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (
such as changes in paying office,
appropriation date, etc. ) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b). |
|||||
|
C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF
|
|||||
x
|
D. OTHER (
Specify type of modification and authority
)
Bilateral: Mutual Agreement of the Parties.
|
|||||
E. IMPORTANT
: Contractor
¨
is not
ý
is required to sign this document and return
0
copies to the issuing office
|
|
|||||
14. DESCRIPTION OF AMENDMENT/MODIFICATION (
Organized by UCF section headings, including solicitation/contract subject matter where feasible
)
Tax ID Number: 33-0903395
DUNS Number: 121785997
A. The purpose of this bilateral modification is to incorporate the following changes into the contract:
1. Add cost growth funding in the amount of $2,340,571.00 (No Fixed Fee) for the purpose of funding additional time for the completion of Option 2/CLIN 0003 under Contract Number HHSO100201100013C.
2. As a result of adding additional funding to Option 2/CLIN 0003 under Contract Number HHSO100201100013, Option 2/CLIN 0003 is here by revised as follows:
Continued …
|
|
|||||
Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.
|
|
|||||
15A NAME AND TITLE OF SIGNER (
type or print
)
M. Michelle Berrey CEO
|
16A NAME AND TITLE OF CONTRACTING OFFICER (
Type or print
)
ETHAN J. MUELLER
|
|
||||
15B CONTRACTOR/OFFEROR
/s/ M. Michelle Berrey
|
15C DATE SIGNED
12/21/18
|
16B UNITED STATES OF AMERICA
/s/ Ethan J. Mueller
|
16C. DATE SIGNED
1/10/19
|
|||
(Signature of person authorized to sign)
|
|
(Signature of Contracting Officer)
|
|
CONTINUATION SHEET
|
REFERENCE NO. OF DOCUMENT BEING CONTINUED
HHSO100201100013C/0055
|
PAGE OF
|
||||||
2
|
3
|
|||||||
NAME OF OFFEROR OR CONTRACTOR
CHIMERIX, INC. 1377270
|
||||||||
ITEM NO.
(A)
|
SUPPLIES/SERVICES
(B)
|
QUANTITY
(C)
|
UNIT
(D)
|
UNIT PRICE
(E)
|
AMOUNT
(F)
|
|||
|
Total Estimated Cost: from $[...***...] By $2,340,571.00 to $[...***...].
No Change to the Total Fixed Fee of $[...***...].
Total Estimated Cost Plus Fixed Fee: From $[...***...] By $2,340,571.00 To
$[...***...].
3. This modification also results a change in the total amount of the contract from
$[...***...] by $2,340,571.00 to $[...***...] as well as the following:
Total Estimated Cost of the Contract: From $[...***...] By $2,340,571.00 To
$[...***...].
No Change to the Total Fixed Fee of $[...***...].
Total Estimated Cost Plus Fixed Fee of the Contract: From $[...***...] By
$2,340,571.00 To $[...***...].
4. This modification hereby results in a increase in the total amount of the
contract from $[...***...] By $2,340,571.00 to $[...***...].
5. Block 15G of the SF 26, the amount of $[...***...] shall be changed to
$[...***...].
6. Also in Block 14 of the SF 26, the following CAN Number is added as follows:
Appropriation Year: 2019; Object Class: 25016; CAN 1992019 $2,340,571.00.
7. The period of performance for Option 2/CLIN 0003 of Contract Number
HHSO100201100013C is hereby changed from 1 September 2014 through 30 March 2019 to 1 September 2014 through 1 August 2019.
8. The Statement of Work under Contract Number HHSO100201100013 hereby remains
unchanged.
9. For the Option 2/CLIN 0003, cost growth for this Modification 55, Total
Estimated Cost (No Fixed Fee) - $2,340,571.00, Only, the following Indirect Cost Ceiling Rates are established for which Chimerix cannot seek reimbursement in excess of the following Indirect Cost Ceiling Rates:
[...***...]% Fringe, [...***...]% G&A
10. The total amount, scope and period of performance of all other CLINs that are
currently 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 Continued ... |
Grant Date
|
Type of Award
|
Total Shares Underlying
Outstanding Awards |
Exercise Price per Share
|
Shares Vested as of
Separation Date |
Shares Accelerated Pursuant to Severance Plan & Participation
Agreement |
Total Vested Shares as of
Separation Date |
1/23/2019
|
Stock Option
|
400,000
|
$2.41
|
0
|
125,000
|
125,000
|
1/25/2018
|
Stock Option
|
400,000
|
$4.68
|
100,000
|
125,000
|
225,000
|
1/24/2017
|
Stock Option
|
148,000
|
$5.14
|
74,000
|
46,250
|
120,250
|
1/24/2017
|
RSU Award
|
74,000
|
N/A
|
37,000
|
23,125
|
60,125
|
5/9/2016
|
RSU Award
|
100,000
|
N/A
|
75,000
|
25,000
|
100,000
|
1/8/2016
|
Stock Option
|
483,600
|
$8.06
|
362,700
|
120,900
|
483,600
|
1/28/2015
|
Stock Option
|
184,200
|
$39.41
|
184,200
|
0
|
184,200
|
4/9/2014
|
Stock Option
|
140,000
|
$21.92
|
140,000
|
0
|
140,000
|
1/28/2014
|
Stock Option
|
58,713
|
$18.75
|
58,713
|
0
|
58,713
|
11/18/2012
|
Stock Option
|
15,161
|
$4.26
|
15,161
|
0
|
15,161
|
Total
|
|
2,003,674
|
|
1,046,774
|
465,275
|
1,512,049
|
Base Salary:
|
Your per pay period base salary will be $8,750.00 (annualized, $210,000.00). Currently, paychecks are issued semi-monthly for a total of 24 pay periods per year.
|
Stock Options
:
|
You will be granted an option to purchase 50,000 shares of Chimerix common stock. All stock option grants are subject to the vesting schedule and terms and conditions outlined in the Chimerix 2012 Equity Incentive Plan (“the Plan”). You will be issued a grant notice, option agreement and details of the Plan. Such shares shall vest over a period of four (4) years so long as you continue to provide services to the Company, with 25% vesting one year from the vesting commencement date and the balance vesting at the rate of 1/36 per month over the remaining three (3) years.
|
Target Bonus:
|
For calendar year 2012, you will be eligible for a target bonus of 15% of the base salary paid to you in 2012. Such bonus is paid in 2013 and is based upon your achievement of the goals and objectives agreed to in the performance dialog process with your manager and the formula determined by the Board of Directors for 2012.
|
Deferred Signing
|
If you remain employed with Chimerix until May 31, 2013, or if
|
Bonus:
|
Chimerix terminates your employment “without cause” between June 1, 2012 and May 31, 2013, then Chimerix shall pay you a bonus in the amount of $25,000 within thirty days following the earlier of your termination of employment “without cause” or May 31, 2013. Additionally, if you remain employed with Chimerix until May 31, 2014 or if Chimerix terminates your employment “without cause” between June 1, 2013 and May 31, 2014, Chimerix
|
Benefits:
|
As an employee of Chimerix you will be eligible for comprehensive health and dental insurance benefits for yourself and your eligible dependents, effective on the first day of employment. For 2012, Chimerix pays the entire monthly premium for this coverage. You will also be eligible for Company-paid term life insurance, short term and long-term disability insurance, effective on your hire date.
|
1.
|
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.,
|
2.
|
Registration Statement (Form S-8 Nos. 333-194408, 333-202582, 333-209802, 333-216396 and 333-223344) pertaining to the 2013 Equity Incentive Plan and 2013 Employee Stock Purchase Plan of Chimerix, Inc., and
|
3.
|
Registration Statement (Form S-3 No. 333-221412) of Chimerix, Inc.;
|
|
|
/s/ Ernst & Young LLP
|
|
|
|
Raleigh, North Carolina
|
|
|
March 5, 2019
|
|
|
Date:
|
March 5, 2019
|
|
/s/ Michael A. Alrutz
|
|
|
|
Michael A. Alrutz
|
|
|
|
Principal Executive Officer
|
Date:
|
March 5, 2019
|
|
/s/ Timothy W. Trost
|
|
|
|
Timothy W. Trost
Principal Financial and Accounting Officer
|
Date:
|
March 5, 2019
|
|
/s/ Michael A. Alrutz
|
|
|
|
Michael A. Alrutz
|
|
|
|
Principal Executive Officer
|
Date:
|
March 5, 2019
|
|
/s/ Timothy W. Trost
|
|
|
|
Timothy W. Trost
Principal Financial and Accounting Officer
|