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Delaware
(State or other jurisdiction of
incorporation or organization)
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45‑0705648
(I.R.S. Employer
Identification No.)
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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, $0.001, par value
Class A Warrants, consisting of the right to purchase one share of common stock at an exercise price of $4.55 per share Class B Warrants, consisting of the right to purchase one-half share of common stock at an exercise price of $3.90 per share |
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NASDAQ Stock Market
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Large accelerated filer ☐
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Accelerated filer ☐
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Non‑accelerated filer ☐
(Do not check if a
smaller reporting company)
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Smaller reporting company
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Emerging growth company
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PART IV
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Growing sales of the existing products in our portfolio, including by identifying and investing in growth opportunities such as new treatment indications and new geographic markets;
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Acquiring or licensing rights to clinically meaningful and differentiated products that are already on the market for pediatric use or product candidates that are in late-stage development for pediatric indications that are near market launch; and
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Pursuing targeted clinical-stage development assets that are differentiated product candidates for rare neurological disorders or orphan diseases.
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CERC-611: Adjunctive Treatment of Partial-Onset Seizures in Epilepsy.
CERC-611, is a preclinical asset that is a potent and selective antagonist of transmembrane alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) receptor regulatory protein (“TARP”)-γ8-dependent AMPA receptor. We believe CERC-611 is the first drug candidate to selectively target and functionally block region-specific AMPA receptors after oral dosing, which we believe may improve the efficacy and side effect profile of CERC-611 over current anti-epileptics. Research also suggests that selectively targeting individual TARPs may enable selective modulation of specific brain circuits without globally affecting synaptic transmission. We intend to develop CERC-611 as an adjunctive therapy for the treatment of partial-onset seizures, with or without secondarily generalized seizures, in patients with epilepsy.
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CERC-406 and CERC-425:
We believe these compounds have potential for treatments associated with motoric and non-motoric symptoms of Parkinson's Disease as well as other psychiatric and neurological conditions frequently impacted by impaired cognition.
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Generate revenue through sales of marketed pediatric products acquired from TRx and Avadel.
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Develop other products, including CERC-301 as an adjunctive therapy for
Neurogenic orthostatic hypotension (“nOH”), and the product candidates under our development arrangement with Avadel
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Pursue opportunistic acquisitions of additional complementary marketed products and development stage companies. We will identify, along with Avadel Ireland, four stable product formulations of Cerecor’s choosing utilizing its proprietary LiquiTime™ and Micropump® technology. Cerecor has chosen three of these development projects which are already underway.
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Product Candidate / Platform
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Potential
Indication(s)
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Stage of
Development
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Anticipated
Milestones
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CERC
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301
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Neurogenic orthostatic hypotension (nOH)
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Phase 1 Safety Study
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Initiate clinical study in 2018
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CERC
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611
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Adjunctive treatment of partial-onset seizures in epilepsy
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Preclinical
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IND acceptance (timing dependent on further evaluation of the molecule)
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COMT Inhibitors
CERC
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406
CERC‑425
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Residual motoric and non-motoric cognitive impairment symptoms as well as other psychiatric and neurological diseases
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Preclinical
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IND submission (timing dependent on further evaluation of the molecule)
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Have efficacy in refractory partial-onset seizures as an adjunctive therapy. It may be uniquely qualified to treat temporal lobe seizures, unlike any other current or pipeline therapy, due to its selectivity for the TARP γ8-dependent AMPA receptors
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Lack sedative, ataxic, or falling side effects of global AMPA receptor antagonists such as perampanel-Fycompa™
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Have a reduced or absent requirement for multi-week dose titration
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Potentially mitigate some of the side-effect liabilities associated with other conjointly administered antiepileptic medications.
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demonstrate efficacy as it is a brain penetrant COMT inhibitor with selectivity for MB‑COMT to target the PFC dopamine deficit in this patient population;
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be more effective in Val homozygotes population, who have higher levels of COMT activity and lower prefrontal dopamine receptor activation; and
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be safer than existing COMT inhibitors- which are associated with adverse events such as liver toxicity and diarrhea.
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CERC
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301.
We possess worldwide exclusive rights to manufacture, use, and sell certain NR2B antagonist compounds. The CERC‑301 patent portfolio consists of three patent families. The first family consists of patents that have issued in the United States (U.S.), Australia, Canada, Germany, France, United Kingdom, Switzerland, and Japan. The patents in the first family include composition of matter and use claims of varying scope, including picture claims to CERC‑301 or a pharmaceutically acceptable salt thereof. The expiration date of the U.S. patent in the first family is August 31, 2026, not including any patent term extension or market exclusivity period which may apply. The second family consists of patents that have issued in U.S., Germany, France, and United Kingdom.The patents in the second family include composition of matter claims (in U.S. patent only) and use claims that generically cover CERC‑301. The expiration date of the U.S. patent is June 3, 2022, not including any potential patent term extension or market exclusivity period.The third family consists of patent applications in U.S., Argentina, Australia, Brazil, Canada, China, Europe, India, Japan, Mexico, Russia, South Korea, and Taiwan, with claims to compositions of matter, methods of use, and methods of manufacture. Any patents issuing from these applications would expire in December 2035 at the earliest, not including any potential patent term adjustment, patent term extension, or market exclusivity period.
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CERC-611.
W
e possess worldwide exclusive rights to manufacture, use, and sell LY3130481, now known as CERC‑611. The CERC-611 patent portfolio consists of two patent families. The first family consists of patents that have issued in U.S., Australia, Canada, China, Eurasia, Europe, Japan, Singapore, South Africa, South Korea, Ukraine, and Vietnam, and over 20 international patent applications with composition of matter and use claims for CERC-611. The expiration date of the U.S. patent, exclusive of any patent term extension, is November 20, 2033. The second family consists of patents that have issued in U.S., Australia, and South Korea, and international patent applications with composition of matter and use claims of varying scope for additional selective TARP γ8-dependent AMPA receptor antagonists. The expiration date of the U.S. patent, exclusive of any patent term extension, is May 21, 2035.
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CERC
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406, CERC-425 and COMTi Platform.
We possess worldwide exclusive rights to manufacture, use, and sell COMT inhibitor compounds. The COMT patent portfolio consists of two patent families. The first family consists of patents that have issued in U.S., Australia, Canada, China, Japan, South Korea, Mexico, and Russia, and patent applications in Brazil, Europe, and India. The expiration date of the U.S. patent in the first family, exclusive of any patent term extension, is February 28, 2031. The second family consists of patents that have issued in U.S., Australia, China, Europe, Japan, South Korea, Mexico, and Russia, and patent applications in Brazil, Canada, and India. The expiration date of the U.S. patent in the second family, exclusive of any patent term extension, is February 28, 2031.
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identifying and validating targets;
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screening compounds against targets;
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preclinical and clinical trials of potential pharmaceutical products; and
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obtaining FDA and other regulatory clearances.
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capital resources;
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research and development resources;
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manufacturing capabilities; and
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sales and marketing.
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completion of preclinical laboratory tests, animal studies and formulation studies in compliance with the FDA’s good laboratory practice, or GLP, regulations;
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submission to the FDA of an IND which must become effective before human clinical trials may begin;
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approval by local or central independent institutional review boards, or IRB, before each clinical trial may be initiated;
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performance of human clinical trials, including adequate and well‑controlled clinical trials, in accordance with good clinical practices, or GCP, and regulations to establish the safety and efficacy of the proposed drug product for each indication;
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submission to the FDA of an NDA;
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satisfactory completion of an FDA advisory committee review, if applicable;
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satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the product is produced to assess compliance with current good manufacturing practice, or GMP, regulations and to assure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity, as well as satisfactory completion of an FDA inspection of selected clinical sites to determine GCP compliance; and
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FDA review and approval of the NDA.
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restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls;
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fines, Warning Letters or Untitled Letters, holds or termination of post‑approval clinical trials or FDA debarment;
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delay or refusal of the FDA to approve pending NDAs or supplements to approved NDAs, or suspension or revocation of product license approvals;
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regulatory authority, including the FDA, issued safety alerts, Dear Healthcare Provider letters, press releases or other communications containing warnings about such products;
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mandated modifications to promotional material or issuance of corrective information;
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product seizure or detention, or refusal to permit the import or export of products; or
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injunctions or the imposition of civil or criminal penalties, including imprisonment, disgorgement and restitution, as well as consent decrees, corporate integrity agreements, deferred prosecution agreements and exclusion from federal healthcare programs.
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the required patent information has not been filed;
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the listed patent has expired;
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the listed patent has not expired, but will expire on a particular date and approval is sought after patent expiration; or
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the listed patent is invalid, unenforceable, or will not be infringed by the new product.
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Decentralized procedure.
Using the decentralized procedure, an applicant may apply for simultaneous authorization in more than one European Union country of medicinal products that have not yet been authorized in any European Union country and that do not fall within the mandatory scope of the centralized procedure.
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Mutual recognition procedure.
In the mutual recognition procedure, a medicine is first authorized in one European Union Member State, in accordance with the national procedures of that country. Following this, further marketing authorizations can be sought from other European Union countries in a procedure whereby the countries concerned agree to recognize the validity of the original, national marketing authorization.
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delays in reaching an agreement with or failure in obtaining authorization from the FDA, other regulatory authorities or institutional review boards, or IRBs, to commence or amend a clinical trial;
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imposition of a clinical hold or trial termination following an inspection of our clinical trial operations or trial sites by the FDA or other regulatory authorities, or due to concerns about trial design, or a decision by the FDA, other regulatory authorities, IRBs or the company, or recommendation by a data safety monitoring board, to place the trial on hold or otherwise suspend or terminate clinical trials at any time for safety issues or for any other reason;
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delays in reaching agreement on acceptable terms with prospective CROs and clinical trial sites;
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deviations from the trial protocol by clinical trial sites and investigators, or failing to conduct the trial in accordance with regulatory requirements;
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failure of our third parties, such as CROs, to satisfy their contractual duties or meet expected deadlines;
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failure to enter into agreements with third parties to obtain the results of clinical trials;
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delays in the importation and manufacture of clinical supply;
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delays in the testing, validation and delivery of the clinical supply of the product candidates to the clinical sites;
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for clinical trials in selected subject populations, delays in identification and auditing of central or other laboratories and the transfer and validation of assays or tests to be used to identify selected subjects;
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delays in recruiting suitable subjects 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 disease progression;
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delays in adding new investigators and clinical trial sites;
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withdrawal of clinical trial sites from our clinical trials as a result of changing standards of care or the ineligibility of a site to participate in our clinical trials; or
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changes in government regulations or administrative actions or lack of adequate funding to continue the clinical trials.
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the size and nature of the subject population;
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the number and location of clinical sites we enroll;
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the proximity of subjects to clinical sites;
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perceived risks and benefits of the product candidate under trial;
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competition with other companies for clinical sites or subjects;
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competing clinical trials;
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the eligibility and exclusion criteria for the trial;
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the design of the clinical trial;
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effectiveness of publicity for the clinical trials;
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inability to obtain and maintain subject consents;
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ability to monitor subjects adequately during and after the administration of the product candidate and the ability of subjects to comply with the clinical trial requirements;
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risk that enrolled subjects will drop out or be withdrawn before completion; and
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clinicians’ and subjects’ perceptions as to the potential advantages of the drug being studied in relation to other available therapies, including any new drugs that may be approved for the indications we are investigating.
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our methodology, including our screening technology, might not successfully identify medically relevant potential product candidates;
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our competitors may develop alternatives that render our product candidates obsolete;
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we may encounter product manufacturing difficulties that limit yield or produce undesirable characteristics that increase the cost of goods, cause delays or make the product candidates unmarketable;
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our product candidates may cause adverse effects in subjects, even after successful initial toxicology studies, which may make the product candidates unmarketable;
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our product candidates might not be capable of being produced in commercial quantities at an acceptable cost, or at all;
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our product candidates might not demonstrate a meaningful benefit to subjects;
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our potential collaboration partners may change their development profiles or plans for potential product candidates or abandon a therapeutic area or the development of a partnered product; and
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our reliance on third party clinical trials may cause us to be denied access to clinical results that may be significant to further clinical development.
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the FDA or comparable foreign regulatory authorities may disagree on the design or implementation of our clinical trials, including the methodology used in our trial, our chosen endpoints, our statistical analysis, or our proposed product indication. For instance, the FDA may find that the designs that we are utilizing in our planned clinical trial do not support an adequate and well‑controlled study. The FDA also might not agree with the various depression and other disease scales and evaluation tools that we may use in our clinical trials to assess the efficacy of our product candidates. Further, the FDA might not agree with our endpoints and/or indications selected for our trials;
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the FDA or comparable foreign regulatory authorities may disagree with our development plans for our product candidates.;
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our failure to demonstrate to the satisfaction of the FDA or comparable regulatory authorities that a product candidate is safe and effective for its proposed indication;
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our clinical trials may fail to meet the level of statistical significance required for approval. For example, in a proof of concept study of CERC‑301 conducted by the National Institute of Mental Health, CERC‑301 failed to provide a significant improvement in subjects receiving the compound as compared to those receiving a placebo, as measured by the Montgomery‑Asberg Depression Rating Scale, the primary assessment tool. Further, neither CERC-301 nor CERC-501 met the primary endpoint in its respective Phase 2 clinical trial, and previously our Clin301‑201 Phase 2 study for CERC‑301 failed to meet its primary endpoint;
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we may fail to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;
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the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials;
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data collected from clinical trials of our product candidates may be insufficient to support the submission and filing of an NDA, other submission or to obtain marketing approval, and FDA may require additional studies to show that our product candidates are safe or effective;
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we may fail to obtain approval of the manufacturing processes or facilities of third‑party manufacturers with whom we contract for clinical and commercial supplies; or
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there may be changes in the approval policies or regulations that render our preclinical and clinical data insufficient for approval.
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we may suspend marketing of, or withdraw or recall, such product;
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regulatory authorities may withdraw approvals of such product;
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regulatory authorities may require additional warnings on the label or other label modifications;
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the FDA or other regulatory bodies may issue safety alerts, Dear Healthcare Provider letters, press releases or other communications containing warnings about such product;
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the FDA may require the establishment or modification of a REMS or other restrictions on marketing and distribution, or a comparable foreign regulatory authority may require the establishment or modification of a similar strategy that may, for instance, require us to issue a medication guide outlining the risks of such side effects for distribution to patients or restrict distribution of our products and impose burdensome implementation requirements on us;
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regulatory authorities may require that we conduct post‑marketing studies;
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we could be sued and held liable for harm caused to subjects or patients; and
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our reputation may suffer.
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issue Warning Letters or Untitled Letters;
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mandate modifications to promotional materials or labeling, or require us to provide corrective information to healthcare practitioners;
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require us to enter into a consent decree, which can include imposition of various fines, reimbursements for inspection costs, required due dates for specific actions and penalties for noncompliance;
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seek an injunction or impose civil or criminal penalties or monetary fines, restitution or disgorgement, as well as imprisonment;
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suspend or withdraw marketing approval;
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suspend or terminate any ongoing clinical studies;
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refuse to approve pending applications or supplements to applications filed by us;
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debar us from submitting marketing applications, exclude us from participation in federal healthcare programs, require a corporate integrity agreement or deferred prosecution agreements, debar us from government contracts and refuse future orders under existing contracts;
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suspend or impose restrictions on operations, including restrictions on marketing, distribution or manufacturing of the product, or the imposition of costly new manufacturing requirements or use of alternative suppliers; or
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seize or detain products, refuse to permit the import or export of products, or request that we initiate a product recall.
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different regulatory requirements for approval of drugs in foreign countries;
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the potential for so‑called parallel importing, which is what happens when a local seller, faced with high or higher local prices, opts to import goods from a foreign market (with low or lower prices) rather than buying them locally;
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challenges enforcing our contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellectual property rights to the same extent as the United States;
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unexpected changes in tariffs, trade barriers and regulatory 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 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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difficulties staffing and managing foreign operations;
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workforce uncertainty in countries where labor unrest is more common than in the United States;
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potential liability under the Foreign Corrupt Practices Act of 1977 or comparable foreign regulations;
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production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and
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business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters including earthquakes, typhoons, floods and fires.
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the efficacy and safety profile of our product candidates, including relative to marketed products and product candidates in development by third parties;
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the claims we may make for our product candidates based on the approved label or any restrictions placed upon our marketing and distribution of our product candidates;
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the time it takes for our product candidates to complete clinical development and receive marketing approval;
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how quickly and effectively we alone, or with a partner, can market and launch any of our product candidates that receive marketing approval;
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the ability to commercialize any of our product candidates that receive marketing approval;
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the price of our products, including in comparison to branded or generic competitors;
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the ability to collaborate with others in the development and commercialization of new products;
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whether coverage and adequate levels of reimbursement are available under private and governmental health insurance plans, including Medicare;
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the ability to establish, maintain and protect intellectual property rights related to our product candidates;
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the entry of generic versions of our products onto the market;
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the number of products in the same therapeutic class as our product candidates;
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the ability to secure favorable managed care formulary positions, including federal healthcare program formularies;
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the ability to manufacture commercial quantities of any of our product candidates that receive marketing approval; and
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acceptance of any of our product candidates that receive marketing approval by physicians and other healthcare providers.
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expanded manufacturers’ rebate liability under the Medicaid Drug Rebate Program by increasing the minimum rebate for both branded and generic drugs;
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revised the definition of “average manufacturer price,” or AMP, for reporting purposes, which can increase the amount of Medicaid drug rebates manufacturers are required to pay to states, and created a separate AMP for certain categories of drugs provided in non‑retail outpatient settings;
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extended Medicaid drug rebates, previously due only on fee‑for‑service utilization, to Medicaid managed care utilization;
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created an alternative rebate formula for certain new formulations of certain existing products that is intended to increase the amount of rebates due on those drugs;
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expanded the types of entities eligible to receive discounted 340B pricing, although, with the exception of children’s hospitals, these newly eligible entities will not be eligible to receive discounted 340B pricing on orphan drugs. In addition, because 340B pricing is determined based on AMP and Medicaid drug rebate data, the revisions to the Medicaid rebate formula and AMP definition described above can cause the required 340B discounts to increase;
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imposed a significant annual fee on companies that manufacture or import branded prescription drug products;
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required manufacturers to provide a 50% discount off the negotiated price of prescriptions filled by beneficiaries in the Medicare Part D coverage gap, referred to as the “donut hole”; and
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enacted substantial new provisions affecting compliance which may affect our business practices with healthcare practitioners.
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decreased demand for any product candidates or products that we may develop;
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termination of clinical trial sites or entire trial programs;
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injury to our reputation and significant negative media attention;
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withdrawal of clinical trial participants;
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significant costs to defend the related litigation;
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substantial monetary awards to trial subjects or patients;
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loss of revenue;
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product recalls, withdrawals or labeling, marketing or promotional restrictions;
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diversion of management and scientific resources from our business operations;
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the inability to commercialize any products that we may develop; and
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a decline in our stock price.
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the federal Anti‑Kickback Statute prohibits persons from, among other things, knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward, or in return for, the referral of an individual for the furnishing or arranging for the furnishing, or the purchase, lease or order, or arranging for or recommending purchase, lease or order, of any good or service for which payment may be made under a federal healthcare program such as Medicare and Medicaid;
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the civil federal False Claims Act imposes civil penalties, including through civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent; knowingly making, using or causing to be made or used, a false record or statement to get a false or fraudulent claim paid or approved by the government; conspiring to defraud the government by getting a false or fraudulent claim paid or approved by the government; or knowingly making, using or causing to be made or used a false record or statement to avoid, decrease or conceal an obligation to pay money to the federal government. Civil False Claims Act liability may be imposed for Medicare or Medicaid overpayments, for example, overpayments caused by understated rebate amounts, that are not refunded within 60 days of discovering the overpayment, even if the overpayment was not cause by a false or fraudulent act;
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the criminal federal False Claims Act imposes criminal fines or imprisonment against individuals or entities who willfully make or present a claim to the government knowing such claim to be false, fictitious or fraudulent;
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the Veterans Health Care Act requires manufacturers of covered drugs to offer them for sale on the Federal Supply Schedule, which requires compliance with applicable federal procurement laws and regulations and subjects us to contractual remedies as well as administrative, civil and criminal sanctions;
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the federal Health Insurance Portability and Accountability Act and its related regulations, collectively HIPAA, impose criminal liability for, among other actions, knowingly and willfully executing a scheme to defraud any healthcare benefit program, knowingly and willfully embezzling or stealing from a health care benefit program, willfully obstructing a criminal investigation of a health care offense, or knowingly and willfully making false statements relating to healthcare matters;
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HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 and its implementing regulations, also imposes obligations on certain covered entity health care providers, health plans, and health care clearinghouses as well as their business associates that perform certain services involving individually identifiable health information, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information, as well as directly applicable privacy and security standards and requirements
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the civil monetary penalties statute imposes penalties against any person or entity who, among other things, is determined to have presented or caused to be presented a claim to a federal health program that the person knows or should know is for an item or service that was not provided as claimed or is false or fraudulent;
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the federal Physician Sunshine Act, created under Section 6002 of the Affordable Care Act and its implementing regulations, requires manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the Centers for Medicare and Medicaid Services, or CMS, information related to payments or other “transfers of value” made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, and requires applicable manufacturers and applicable group purchasing organizations to report annually to CMS ownership and investment interests held by physicians (as defined above) and their immediate family members;
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the Foreign Corrupt Practices Act, or FCPA, prohibits any U.S. individual or business from paying, offering, or authorizing payment or offering of anything of value, directly or indirectly, to any foreign official, political party or candidate for the purpose of influencing any act or decision of the foreign entity in order to assist the individual or business in obtaining or retaining business. The FCPA also obligates companies whose securities are listed in the United States to comply with accounting provisions requiring the company to maintain books and records that accurately and fairly reflect all transactions of the corporation, including international subsidiaries, and to devise and maintain an adequate system of internal accounting controls for international operations; and
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analogous or similar state, federal, and foreign laws, regulations, and requirements such as state anti‑kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services
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our inability to recruit and retain adequate numbers of effective sales and marketing personnel;
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the inability of sales personnel to obtain access to physicians or educate adequate numbers of physicians on the clinical benefits of our products to achieve market acceptance;
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the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines;
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the costs associated with training sales personnel on legal compliance matters and monitoring their actions;
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liability for sales personnel failing to comply with the applicable legal requirements; and
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unforeseen costs and expenses associated with creating an independent sales and marketing organization.
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the development of certain of our current or future product candidates may be terminated or delayed;
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our cash expenditures related to development of certain of our current or future product candidates would increase significantly and we may need to seek additional financing, which might not be available on favorable terms, or at all;
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we may be required to hire additional employees or otherwise develop expertise, such as sales and marketing expertise, for which we have not budgeted;
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we will bear all of the risk related to the development of any such product candidates;
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•
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we may have to expend unexpected efforts and funds if we are unable to obtain the results of third party clinical trials; and
|
•
|
the competitiveness of any product candidate that is commercialized could be reduced.
|
•
|
reliance on the third parties for regulatory compliance and quality assurance;
|
•
|
the possible breach of the manufacturing agreements by the third parties because of factors beyond our control;
|
•
|
the possibility of termination or nonrenewal of the agreements by the third parties because of our breach of the manufacturing agreement or based on their own business priorities; and
|
•
|
the disruption and costs associated with changing suppliers, including additional regulatory filings.
|
•
|
significantly delay, scale back or discontinue the development or commercialization of one or more of our product candidates or cease operations altogether;
|
•
|
seek strategic alliances for research and development programs at an earlier stage than we would otherwise desire or on terms less favorable than might otherwise be available; or
|
•
|
relinquish, or license on unfavorable terms, our rights to technologies or any future product candidates that we otherwise would seek to develop or commercialize ourselves.
|
•
|
the integration and profitability of our recently acquired commercial businesses (TRx in November 2017 and Avadel’s pediatric business in February 2018);
|
•
|
the initiation, progress, timing, costs and results of preclinical and clinical studies for our product candidates and future product candidates we may develop;
|
•
|
the outcome, timing and cost of seeking and obtaining regulatory approvals from the FDA and comparable foreign regulatory authorities, including the potential for such authorities to require that we perform more studies than we currently expect to perform;
|
•
|
the cost to establish, 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 licensing, preparing, filing, prosecuting, defending and enforcing any patents or other intellectual property rights;
|
•
|
the effect of competing technological and market developments;
|
•
|
market acceptance of any approved product candidates;
|
•
|
the costs of acquiring, licensing or investing in additional businesses, products, product candidates and technologies;
|
•
|
the cost and timing of selecting, auditing and potentially validating a manufacturing site for commercial‑scale manufacturing; and
|
•
|
the cost of expanding our sales, marketing and distribution capabilities to accommodate any of our product candidates for which we receive marketing approval and that we determine to commercialize ourselves or in collaboration with our partners.
|
•
|
exposure to unknown liabilities;
|
•
|
disruption of our business and diversion of our management’s time and attention in order to develop acquired products, product candidates or technologies;
|
•
|
incurrence of substantial debt or dilutive issuances of equity securities to pay for acquisitions;
|
•
|
higher than expected acquisition and integration costs;
|
•
|
write‑downs of assets or goodwill or impairment charges;
|
•
|
increased amortization expenses;
|
•
|
difficulty and cost in combining the operations and personnel of any acquired businesses with our operations and personnel;
|
•
|
impairment of relationships with key suppliers or other counterparties of any acquired businesses due to changes in management and ownership; and
|
•
|
inability to retain key employees of any acquired businesses.
|
•
|
our ability to generate significant product revenues, cash flows and a profit;
|
•
|
the development status of our product candidates, and when any of our product candidates receive marketing approval;
|
•
|
our decision to initiate a clinical trial, not to initiate a clinical trial or to terminate an existing clinical trial;
|
•
|
our failure to commercialize our product candidates, if approved;
|
•
|
the success of competitive products or technologies;
|
•
|
regulatory actions with respect to our products or our competitors’ products;
|
•
|
actual or anticipated changes in our growth rate relative to our competitors;
|
•
|
announcements by us or our competitors of significant acquisitions, strategic collaborations, joint ventures, collaborations or capital commitments;
|
•
|
results of preclinical studies and clinical trials of our product candidates or those of our competitors;
|
•
|
regulatory or legal developments in the United States and other countries;
|
•
|
developments or disputes concerning patent applications, issued patents or other proprietary rights;
|
•
|
the recruitment or departure of key personnel;
|
•
|
the level of expenses related to any of our product candidates or clinical development programs;
|
•
|
the results of our efforts to discover, develop, in‑license or acquire additional product candidates or products;
|
•
|
actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts;
|
•
|
the performance of third parties on whom we rely to manufacture our products and product candidates, supply API and conduct our clinical trials, including their ability to comply with regulatory requirements;
|
•
|
variations in our financial results or those of companies that are perceived to be similar to us;
|
•
|
variations in the level of expenses related to our product candidates or preclinical and clinical development programs, including relating to the timing of invoices from, and other billing practices of, our contract research organizations and clinical trial sites;
|
•
|
fluctuations in the valuation of companies perceived by investors to be comparable to us;
|
•
|
warrant or share price and volume fluctuations attributable to inconsistent trading volume levels of our warrants or shares;
|
•
|
announcement or expectation of additional financing efforts;
|
•
|
sales of our warrants or shares of our common stock by us, our insiders or our other security holders;
|
•
|
changes in the structure of healthcare payment systems;
|
•
|
changes in operating performance and stock market valuations of other pharmaceutical companies;
|
•
|
market conditions in the pharmaceutical and biotechnology sectors;
|
•
|
our execution of collaborative, co‑promotion, licensing or other arrangements, and the timing of payments we may make or receive under these arrangements;
|
•
|
the public’s response to press releases or other public announcements by us or third parties, including our filings with the SEC and announcements relating to litigation or other disputes, strategic transactions or intellectual property impacting us or our business;
|
•
|
the financial projections we may provide to the public, any changes in these projections or our failure to meet these projections;
|
•
|
changes in financial estimates by any securities analysts who follow our warrants or shares of common stock, our failure to meet these estimates or failure of those analysts to initiate or maintain coverage of our warrants or shares of common stock;
|
•
|
ratings downgrades by any securities analysts who follow our warrants or shares of common stock;
|
•
|
the development and sustainability of an active trading market for our warrants or shares of common stock;
|
•
|
future sales of our warrants or shares of common stock by our officers, directors and significant stockholders;
|
•
|
other events or factors, including those resulting from war, incidents of terrorism, natural disasters or responses to these events;
|
•
|
changes in accounting principles; and
|
•
|
general economic, industry and market conditions.
|
•
|
the provisions of Section 404(b) of the Sarbanes‑Oxley Act of 2002, or Sarbanes‑Oxley Act, requiring that our independent registered public accounting firm provide an attestation report on the effectiveness of our internal control over financial reporting;
|
•
|
the “say on pay” provisions (requiring a non‑binding shareholder vote to approve compensation of certain executive officers) and the “say on golden parachute” provisions (requiring a non‑binding shareholder vote to approve golden parachute arrangements for certain executive officers in connection with mergers and certain other business combinations) of the
|
•
|
the requirement to provide detailed compensation discussion and analysis in proxy statements and reports filed under the Securities Exchange Act of 1934, as amended, or the Exchange Act, and instead provide a reduced level of disclosure concerning executive compensation; and
|
•
|
any rules that the Public Company Accounting Oversight Board may adopt requiring mandatory audit firm rotation or a supplement to the auditor’s report on the financial statements.
|
•
|
authorizing the issuance of “blank check” preferred stock, the terms of which we may establish and shares of which we may issue without stockholder approval;
|
•
|
prohibiting cumulative voting in the election of directors, which would otherwise allow for less than a majority of stockholders to elect director candidates;
|
•
|
prohibiting stockholder action by written consent, thereby requiring all stockholder actions to be taken at a meeting of our stockholders;
|
•
|
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 stockholder meetings.
|
Year Ended December 31, 2017
|
|
|
|
|
|
|
||
First Quarter
|
|
High
|
|
|
Low
|
|
||
Common stock
|
|
$
|
1.24
|
|
|
$
|
0.66
|
|
Class A warrants
|
|
$
|
0.19
|
|
|
$
|
0.01
|
|
Class B warrants
|
|
$
|
—
|
|
|
$
|
—
|
|
Second Quarter
|
|
|
|
|
||||
Common stock
|
|
$
|
0.89
|
|
|
$
|
0.34
|
|
Class A warrants
|
|
$
|
0.12
|
|
|
$
|
0.01
|
|
Class B warrants
|
|
$
|
—
|
|
|
$
|
—
|
|
Third Quarter
|
|
|
|
|
||||
Common stock
|
|
$
|
1.42
|
|
|
$
|
0.52
|
|
Class A warrants
|
|
$
|
0.18
|
|
|
$
|
0.02
|
|
Class B warrants
|
|
$
|
—
|
|
|
$
|
—
|
|
Fourth Quarter
|
|
|
|
|
||||
Common stock
|
|
$
|
4.25
|
|
|
$
|
0.83
|
|
Class A warrants
|
|
$
|
0.60
|
|
|
$
|
0.02
|
|
Class B warrants
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
Year Ended December 31,
|
|||||||||||||||||||
|
|
2017
|
|
2016
|
|
2015
|
|
2014
|
|
2013
|
|||||||||||
Consolidated Statement of Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
License and other revenue
|
|
$
|
25,000,000
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Product revenue, net
|
|
1,910,403
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Sales force revenue
|
|
278,165
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Grant revenue
|
|
624,569
|
|
|
1,152,987
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Total revenues
|
|
27,813,137
|
|
|
1,152,987
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Gross profit
|
|
1,274,755
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Research and development
|
|
4,372,578
|
|
|
10,149,879
|
|
|
6,587,183
|
|
|
12,240,535
|
|
|
8,914,084
|
|
||||||
General and administrative
|
|
7,941,584
|
|
|
7,083,155
|
|
|
4,422,764
|
|
|
4,875,030
|
|
|
4,020,364
|
|
||||||
Sales and marketing
|
|
973,345
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Income (loss) from operations
|
|
13,889,982
|
|
|
(16,080,047
|
)
|
|
(11,009,947
|
)
|
|
(17,115,565
|
)
|
|
(12,934,448
|
)
|
||||||
Change in fair value of warrant liability, unit purchase option liability and investor rights obligation
|
|
(29,624
|
)
|
|
72,625
|
|
|
1,313,049
|
|
|
2,266,161
|
|
|
(121,115
|
)
|
||||||
Interest expense, net
|
|
(24,016
|
)
|
|
(464,181
|
)
|
|
(793,205
|
)
|
|
(1,206,187
|
)
|
|
10,555
|
|
||||||
Total income (loss) before taxes
|
|
13,836,342
|
|
|
(16,471,603
|
)
|
|
(10,490,103
|
)
|
|
(16,055,591
|
)
|
|
(13,045,008
|
)
|
||||||
Income taxes expense
|
|
1,966,519
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Net income (loss) after taxes
|
|
$
|
11,869,823
|
|
|
$
|
(16,471,603
|
)
|
|
$
|
(10,490,103
|
)
|
|
$
|
(16,055,591
|
)
|
|
$
|
(13,045,008
|
)
|
|
Net income (loss)
|
|
$
|
11,869,823
|
|
|
$
|
(16,471,603
|
)
|
|
$
|
(10,490,103
|
)
|
|
$
|
(3,521,153
|
)
|
|
$
|
(13,126,972
|
)
|
|
Net income (loss) attributable to common stockholders
|
|
$
|
7,772,084
|
|
|
$
|
(16,471,603
|
)
|
—
|
|
$
|
(10,490,103
|
)
|
|
$
|
(3,521,153
|
)
|
|
$
|
(13,126,972
|
)
|
Net income (loss) per share of common stock, basic
|
|
$
|
0.42
|
|
|
$
|
(1.87
|
)
|
|
$
|
(4.71
|
)
|
|
$
|
(5.48
|
)
|
|
$
|
(20.72
|
)
|
|
Net income (loss) per share of common stock, diluted
|
|
$
|
0.42
|
|
|
$
|
(1.87
|
)
|
|
$
|
(4.71
|
)
|
|
$
|
(5.48
|
)
|
|
$
|
(20.72
|
)
|
|
Weighted-average shares of common stock outstanding, basic
|
|
18,410,005
|
|
|
8,830,396
|
|
|
2,226,023
|
|
|
642,052
|
|
633,669
|
||||||||
Weighted-average shares of common stock outstanding, diluted
|
|
18,754,799
|
|
|
8,830,396
|
|
|
2,226,023
|
|
|
642,052
|
|
|
633,669
|
|
|
|
As of December 31,
|
||||||||||||||||||
Consolidated Balance Sheet Data:
|
|
2017
|
|
2016
|
|
2015
|
|
2014
|
|
2013
|
||||||||||
Cash and cash equivalents
|
|
$
|
2,472,187
|
|
|
$
|
5,127,958
|
|
|
$
|
21,161,967
|
|
|
$
|
11,742,349
|
|
|
$
|
3,421,480
|
|
Total assets
|
|
43,124,094
|
|
|
5,768,865
|
|
|
21,657,565
|
|
|
12,316,894
|
|
|
5,075,600
|
|
|||||
Long term debt, net of current portion and discount
|
|
—
|
|
|
—
|
|
|
2,353,482
|
|
|
5,308,211
|
|
|
—
|
|
|||||
Total current liabilities
|
|
11,406,437
|
|
|
4,311,863
|
|
|
5,849,818
|
|
|
4,993,816
|
|
|
3,065,642
|
|
|||||
Total liabilities
|
|
15,264,486
|
|
|
5,561,863
|
|
|
8,573,838
|
|
|
10,302,027
|
|
|
3,065,642
|
|
|||||
Convertible preferred stock
|
|
—
|
|
|
—
|
|
|
—
|
|
|
28,345,531
|
|
|
19,856,633
|
|
|||||
Common stock
|
|
31,268
|
|
|
9,434
|
|
|
8,650
|
|
|
650
|
|
|
643
|
|
|||||
Additional paid-in capital
|
|
83,338,136
|
|
|
70,232,651
|
|
|
66,638,557
|
|
|
16,742,063
|
|
|
9,170,468
|
|
|||||
Contingently issuable shares
|
|
2,655,464
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Total stockholders’ equity (deficit)
|
|
27,859,608
|
|
|
207,002
|
|
|
13,083,727
|
|
|
(26,330,664
|
)
|
|
(17,846,675
|
)
|
•
|
CERC-301:
Orphan Neurological Indication
.
CERC‑301 belongs to a class of compounds known as antagonists of the N‑methyl‑D‑aspartate, or NMDA, receptor, a receptor subtype of the glutamate neurotransmitter system that is responsible for controlling neurologic adaptation. We believe CERC‑301 selectively blocks the NMDA receptor subunit 2B, or NR2B (also called GluN2B). Given its specific mechanism of action and demonstrated tolerability profile, we believe CERC-301 may be well suited to address unmet medical needs in neurologic indications. We intend to initiate a Phase I study in 2018 for neurogenic orthostatic hypotension (“nOH”), a condition that is part of a larger category called orthostatic hypotension (OH), which is also known as postural hypotension. nOH is caused by dysfunction in the autonomic nervous system and causes people to feel faint when they stand or sit up. We will continue to explore the use of CERC-301 in orphan neurologic conditions in preclinical and clinical studies.
|
•
|
CERC-611:
Adjunctive Treatment of Partial-Onset Seizures in Epilepsy.
CERC-611 is a potent and selective antagonist of transmembrane alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) receptor regulatory protein (“TARP”)-ã8-dependent AMPA receptor in preclinical development. TARPs are a recently discovered family of proteins that have been found to associate with, and modulate the activity of, AMPA receptors. TARP ã8-dependent AMPA receptors are localized primarily in the hippocampus, a region of the brain with importance in complex partial seizures and particularly relevant to seizure origination and/or propagation. We believe CERC-611 is the first drug candidate to selectively target and functionally block region-specific AMPA receptors after oral dosing, which we believe may improve the efficacy and side effect profile of
|
•
|
CERC-406 and CERC-425:
Residual Motoric and Cognitive Impairment.
CERC-406 is a preclinical candidate from our proprietary platform of compounds that inhibit catechol-O-methyltransferase, or COMT, within the brain, which we refer to as our COMTi platform. We believe CERC 406 may have the potential to be developed for the treatment of residual cognitive impairment symptoms such as Parkinson’s disease.
|
•
|
Growing sales of the existing commercial products in our portfolio, including by identifying and investing in growth opportunities such as new treatment indications and new geographic markets;
|
•
|
Acquiring or licensing rights to clinically meaningful and differentiated products that are already on the market for pediatric use or in late-stage development for pediatric indications that are near market launch; and
|
•
|
Pursuing targeted, differentiated clinical stage product candidates for rare disorders or orphan diseases.
|
•
|
expenses incurred under agreements with third‑party contract research organizations and investigative sites that conduct our clinical trials, preclinical studies and regulatory activities;
|
•
|
payments made to contract manufacturers for drug substance and acquiring, developing and manufacturing clinical trial materials; and
|
•
|
payments related to acquisitions of our product candidates and preclinical platform and
|
•
|
milestone payments, and fees associated with the prosecution and maintenance of patents.
|
•
|
personnel‑related expenses, including salaries, benefits and stock‑based compensation expense;
|
•
|
consulting costs related to our internal research and development programs; allocated facilities, depreciation and other expenses, which include rent and utilities, as well as other supplies; and
|
•
|
product liability insurance.
|
|
|
Year Ended December 31,
|
||||||||||||||||||||||
|
|
2017
|
|
2016
|
|
2015
|
||||||||||||||||||
Risk-free interest rate
|
|
1.85
|
%
|
|
—
|
|
2.38
|
%
|
|
1.01
|
%
|
|
—
|
|
1.93
|
%
|
|
1.64
|
%
|
|
—
|
|
1.97
|
%
|
Expected term of options (in years)
|
|
5.0
|
|
|
—
|
|
6.25
|
|
|
5.0
|
|
|
—
|
|
6.25
|
|
|
5.0
|
|
|
—
|
|
6.25
|
|
Expected stock price volatility
|
|
55
|
%
|
|
—
|
|
100.0
|
%
|
|
80
|
%
|
|
—
|
|
100.0
|
%
|
|
|
|
|
|
70.0
|
%
|
|
Expected annual dividend yield
|
|
|
|
|
|
—
|
%
|
|
|
|
|
|
—
|
%
|
|
|
|
|
|
—
|
%
|
|
|
Year Ended
|
||||||
|
|
December 31,
|
||||||
|
|
2017
|
|
2016
|
||||
|
|
|
|
|
||||
|
|
(in thousands)
|
||||||
License and other revenue
|
|
$
|
25,000
|
|
|
$
|
—
|
|
Product revenue, net
|
|
$
|
1,911
|
|
|
$
|
—
|
|
Sales force revenue
|
|
$
|
278
|
|
|
$
|
—
|
|
Grant revenue
|
|
$
|
625
|
|
|
$
|
1,153
|
|
|
|
Year Ended
|
||||||
|
|
December 31,
|
||||||
|
|
2017
|
|
2016
|
||||
|
|
|
|
|
||||
|
|
(in thousands)
|
||||||
CERC-301
|
|
$
|
1,215
|
|
|
$
|
2,890
|
|
CERC-501
|
|
661
|
|
|
3,122
|
|
||
CERC-611
|
|
494
|
|
|
2,103
|
|
||
COMTi
|
|
62
|
|
|
124
|
|
||
Internal expenses not allocated to programs:
|
|
|
|
|
|
|
||
Salaries, benefits and related costs
|
|
1,433
|
|
|
1,534
|
|
||
Stock-based compensation expense
|
|
152
|
|
|
141
|
|
||
Other
|
|
356
|
|
|
236
|
|
||
|
|
$
|
4,373
|
|
|
$
|
10,150
|
|
|
|
Year Ended
|
||||||
|
|
December 31,
|
||||||
|
|
2017
|
|
2016
|
||||
|
|
|
|
|
||||
|
|
(in thousands)
|
||||||
Salaries, benefits and related costs
|
|
$
|
2,433
|
|
|
$
|
1,922
|
|
Legal, consulting and other professional expenses
|
|
3,944
|
|
|
2,806
|
|
||
Stock-based compensation expense
|
|
1,001
|
|
|
1,554
|
|
||
Amortization of intangible assets
|
|
—
|
|
|
—
|
|
||
Other
|
|
564
|
|
|
801
|
|
||
|
|
$
|
7,942
|
|
|
$
|
7,083
|
|
|
|
Year Ended
|
||||||
|
|
December 31,
|
||||||
|
|
2017
|
|
2016
|
||||
|
|
|
|
|
||||
|
|
(in thousands)
|
||||||
Salaries, benefits and related costs
|
|
$
|
303
|
|
|
$
|
—
|
|
Consulting and other professional expenses
|
|
140
|
|
|
—
|
|
||
Stock-based compensation expense
|
|
4
|
|
|
—
|
|
||
Advertising and marketing expense
|
|
71
|
|
|
|
|
||
Amortization of intangible assets
|
|
404
|
|
|
—
|
|
||
Other
|
|
51
|
|
|
—
|
|
||
|
|
$
|
973
|
|
|
$
|
—
|
|
|
|
Year Ended
|
||||||
|
|
December 31,
|
||||||
|
|
2016
|
|
2015
|
||||
|
|
|
|
|
||||
|
|
(in thousands)
|
||||||
Grant revenue
|
|
$
|
1,153
|
|
|
$
|
—
|
|
|
|
Year Ended
|
||||||
|
|
December 31,
|
||||||
|
|
2016
|
|
2015
|
||||
|
|
|
|
|
||||
|
|
(in thousands)
|
||||||
CERC-301
|
|
$
|
2,890
|
|
|
$
|
3,110
|
|
CERC-501
|
|
3,122
|
|
|
1,481
|
|
||
CERC-611
|
|
2,103
|
|
|
—
|
|
||
COMTi
|
|
124
|
|
|
260
|
|
||
Internal expenses not allocated to programs:
|
|
|
|
|
|
|
||
Salaries, benefits and related costs
|
|
1,534
|
|
|
1,367
|
|
||
Stock-based compensation expense
|
|
141
|
|
|
67
|
|
||
Other
|
|
236
|
|
|
302
|
|
||
|
|
$
|
10,150
|
|
|
$
|
6,587
|
|
|
|
Year Ended
|
||||||
|
|
December 31,
|
||||||
|
|
2016
|
|
2015
|
||||
|
|
|
|
|
||||
|
|
(in thousands)
|
||||||
Salaries, benefits and related costs
|
|
$
|
1,922
|
|
|
$
|
2,326
|
|
Legal, consulting and other professional expenses
|
|
2,806
|
|
|
1,289
|
|
||
Stock-based compensation expense
|
|
1,554
|
|
|
328
|
|
||
Other
|
|
801
|
|
|
480
|
|
||
|
|
$
|
7,083
|
|
|
$
|
4,423
|
|
|
|
Year Ended
|
||||||||||
|
|
December 31,
|
||||||||||
|
|
2017
|
|
2016
|
|
2015
|
||||||
|
|
|
|
|
|
|
||||||
|
|
(in thousands)
|
||||||||||
Net cash provided by (used in):
|
|
|
|
|
|
|
||||||
Operating activities
|
|
$
|
12,519
|
|
|
$
|
(14,573
|
)
|
|
$
|
(10,163
|
)
|
Investing activities
|
|
(18,912
|
)
|
|
(35
|
)
|
|
(20
|
)
|
|||
Financing activities
|
|
3,737
|
|
|
(1,426
|
)
|
|
19,603
|
|
|||
Net increase (decrease) in cash and cash equivalents
|
|
$
|
(2,656
|
)
|
|
$
|
(16,034
|
)
|
|
$
|
9,420
|
|
•
|
sales of our marketed products
|
•
|
the progress of clinical trials for CERC-301 and any changes to our development plan with respect to CERC-301, if any;
|
•
|
our plan and ability to enter into collaborative agreements for the development and commercialization of our product candidates;
|
•
|
the scope, progress, results and costs of researching and developing our product candidates or any future product candidates, both in the United States and in territories outside the United States;
|
•
|
the costs, timing and outcome of regulatory review of our product candidates or any future product candidates, both in the United States and in territories outside the United States;
|
•
|
the costs and timing of future commercialization activities, including product manufacturing, marketing, sales and distribution for any of our product candidates for which we receive marketing approval;
|
•
|
the costs and timing of any product candidate acquisition or in‑licensing opportunities;
|
•
|
any product liability or other lawsuits related to our products;
|
•
|
the expenses needed to attract and retain skilled personnel;
|
•
|
the profits, if any, received from commercial sales of our product candidates for which we receive marketing approval; and
|
•
|
the costs involved in preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending our intellectual property‑related claims, both in the United States and in territories outside the United States
|
|
|
|
|
Less than
|
|
|
|
|
More than
|
||||||||
Contractual Obligation(1)
|
|
Total
|
|
one year
|
|
1 ‑ 3 years
|
|
|
3 years
|
||||||||
Debt obligations (2)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
$
|
—
|
|
Operating lease obligations (3)
|
|
159
|
|
|
159
|
|
|
—
|
|
|
|
—
|
|
||||
Total contractual obligations
|
|
$
|
159
|
|
|
$
|
159
|
|
|
$
|
—
|
|
|
|
$
|
—
|
|
(1)
|
This table does not include any contingent milestone or royalty payments that may become payable to third parties under license agreements because the timing and likelihood of such payments are not known.
|
(2)
|
Amount represents principal and interest cash payments over the life of the debt obligations, including anticipated interest payments that are not recorded on our balance sheet.
|
(3)
|
Operating lease obligations reflect our obligations pursuant to the terms of a lease agreement entered into on August 8, 2013 for our office space located in Baltimore, Maryland.
|
(a)
|
Documents filed as part of this report.
|
1.
|
The following consolidated financial statements of Cerecor, Inc. and Report of Ernst & Young, LLP, Independent Registered Public Accounting Firm, are included in this report:
|
2.
|
List of financial statement schedules. All schedules are omitted because they are not applicable or the required information is shown in the financial statements described above.
|
3.
|
List of Exhibits required by Item 601 of Regulation S-K. See part (b) below.
|
(b)
|
Exhibits
. See the Exhibit Index and Exhibits filed as part of this report.
|
Exhibit
Number
|
|
Description of Exhibit
|
|
|
|
|
|
2.1*
|
|
|
|
|
|
|
|
2.2*
|
|
|
|
|
|
|
|
2.3*
|
|
|
|
|
|
|
|
3.1
|
|
|
|
|
|
|
|
3.1.1
|
|
|
|
|
|
|
|
3.2
|
|
|
|
|
|
|
|
4.1
|
|
|
|
|
|
|
|
4.2
|
|
|
|
|
|
|
|
4.3
|
|
|
|
|
|
|
|
4.4
|
|
|
|
|
|
|
|
4.5
|
|
|
|
|
|
|
|
4.6
|
|
|
|
|
|
|
|
4.7
|
|
|
|
|
|
|
|
4.9
|
|
|
|
|
|
|
|
4.10
|
|
|
|
|
|
|
|
4.11
|
|
|
|
|
|
|
|
4.12
|
|
|
|
|
|
|
4.13
|
|
|
|
|
|
|
|
4.14
|
|
|
|
|
|
|
|
4.15
|
|
|
|
|
|
|
|
10.1 #
|
|
|
|
|
|
|
|
10.2 #
|
|
|
|
|
|
|
|
10.3 #
|
|
|
|
|
|
|
|
10.4 +
|
|
|
|
|
|
|
|
10.5 +
|
|
|
|
|
|
|
|
10.6 +
|
|
|
|
|
|
|
|
10.7 +
|
|
|
|
|
|
|
|
10.8 +
|
|
|
|
|
|
|
|
10.8.1+
|
|
|
Amendment to Offer Letter Agreement by and between Cerecor Inc. and Ronald Marcus, effective as of March 9, 2017.
|
|
|
|
|
10.9 +
|
|
|
|
|
|
|
|
10.10 +
|
|
|
|
|
|
|
|
10.10.1+
|
|
|
Amendment to Offer Letter Agreement by and between Cerecor Inc. and Mariam Morris, effective as of March 9, 2017.
|
|
|
|
|
10.11 +
|
|
|
|
|
|
|
|
10.12 +
|
|
|
|
|
|
|
|
10.13 +
|
|
|
|
|
|
|
|
10.15
|
|
|
|
|
|
|
|
10.16
|
|
|
|
|
|
|
|
10.17
|
|
|
|
|
|
|
|
10.18 +
|
|
|
|
|
|
|
|
10.19 +
|
|
|
|
|
|
|
|
10.20
|
|
|
|
|
|
|
|
10.21 #
|
|
|
|
|
|
|
|
10.21.1
|
|
|
|
|
|
|
|
10.22
|
|
|
|
|
|
|
|
10.23#
|
|
|
|
|
|
|
|
10.24
|
|
|
|
|
|
|
|
10.25+
|
|
|
|
|
|
|
|
21.1
|
|
|
|
|
|
|
|
23.1
|
|
|
|
|
|
|
|
31.1
|
|
|
|
|
|
|
|
31.2
|
|
|
|
|
|
|
|
32.1 **
|
|
|
|
|
|
|
|
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.
|
|
|
|
Cerecor Inc.
|
|
/s/ Peter Greenleaf
|
Peter Greenleaf
|
Chief Executive Officer
|
|
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
/s/ Peter Greenleaf
|
|
Chief Executive Officer and Director
|
|
April 2, 2018
|
Peter Greenleaf
|
|
(Principal Executive Officer)
|
|
|
|
|
|
|
|
/s/ Mariam E. Morris
|
|
Chief Financial Officer
|
|
April 2, 2018
|
Mariam E. Morris
|
|
(Principal Financial and Accounting Officer)
|
|
|
|
|
|
|
|
/s/ Uli Hacksell
|
|
Chairman of the Board
|
|
April 2, 2018
|
Uli Hacksell
|
|
|
|
|
|
|
|
|
|
/s/ Isaac Blech
|
|
Director
|
|
April 2, 2018
|
Isaac Blech
|
|
|
|
|
|
|
|
|
|
/s/ Phil Gutry
|
|
Director
|
|
April 2, 2018
|
Phil Gutry
|
|
|
|
|
|
|
|
|
|
/s/ Magnus Persson
|
|
Director
|
|
April 2, 2018
|
Magnus Persson
|
|
|
|
|
|
|
|
|
|
/s/ Steven J. Boyd
|
|
Director
|
|
April 2, 2018
|
Steven J. Boyd
|
|
|
|
|
|
|
|
|
|
/s/ Robert C. Moscato
|
|
Director
|
|
April 2, 2018
|
Robert C. Moscato
|
|
|
|
|
|
|
|
|
|
/s/ Randal Jones
|
|
Director
|
|
April 2, 2018
|
Randal Jones
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
||||||
|
|
2017
|
|
2016
|
||||
Assets
|
|
|
|
|
||||
Current assets:
|
|
|
|
|
||||
Cash and cash equivalents
|
|
$
|
2,472,187
|
|
|
$
|
5,127,958
|
|
Accounts receivable, net
|
|
3,252,212
|
|
|
132,472
|
|
||
Other receivables
|
|
427,241
|
|
|
—
|
|
||
Escrowed cash receivable
|
|
3,752,390
|
|
|
—
|
|
||
Inventory, net
|
|
382,153
|
|
|
—
|
|
||
Prepaid expenses and other current assets
|
|
703,225
|
|
|
391,253
|
|
||
Restricted cash—current portion
|
|
1,959
|
|
|
11,111
|
|
||
Total current assets
|
|
10,991,367
|
|
|
5,662,794
|
|
||
Property and equipment, net
|
|
44,612
|
|
|
43,243
|
|
||
Intangibles assets, net
|
|
17,664,480
|
|
|
—
|
|
||
Goodwill
|
|
14,292,282
|
|
|
—
|
|
||
Restricted cash, net of current portion
|
|
131,353
|
|
|
62,828
|
|
||
Total assets
|
|
$
|
43,124,094
|
|
|
$
|
5,768,865
|
|
Liabilities and stockholders’ equity
|
|
|
|
|
||||
Current liabilities:
|
|
|
|
|
||||
Term debt, net of discount
|
|
$
|
—
|
|
|
$
|
2,353,667
|
|
Accounts payable
|
|
1,298,980
|
|
|
1,010,209
|
|
||
Accrued expenses and other current liabilities
|
|
7,848,309
|
|
|
947,987
|
|
||
Income taxes payable
|
|
2,259,148
|
|
|
—
|
|
||
Total current liabilities
|
|
11,406,437
|
|
|
4,311,863
|
|
||
Contingent consideration
|
|
2,576,633
|
|
|
—
|
|
||
Deferred tax liability
|
|
7,144
|
|
|
—
|
|
||
License obligations
|
|
1,250,000
|
|
|
1,250,000
|
|
||
Long term liabilities - other
|
|
24,272
|
|
|
—
|
|
||
Total liabilities
|
|
15,264,486
|
|
|
5,561,863
|
|
||
Stockholders’ equity:
|
|
|
|
|
||||
Preferred stock—$0.001 par value; 5,000,000 and zero shares authorized at December 31, 2017 and 2016, respectively; zero shares issued and outstanding at December 31, 2017 and 2016
|
|
—
|
|
|
—
|
|
||
Common stock—$0.001 par value; 200,000,000 shares authorized at December 31, 2017 and 2016; 31,266,989 and 9,434,141 shares issued and outstanding at December 31, 2017 and 2016, respectively
|
|
31,268
|
|
|
9,434
|
|
||
Additional paid-in capital
|
|
83,338,136
|
|
|
70,232,651
|
|
||
Contingently issuable shares
|
|
2,655,464
|
|
|
—
|
|
||
Accumulated deficit
|
|
(58,165,260
|
)
|
|
(70,035,083
|
)
|
||
Total stockholders’ equity
|
|
27,859,608
|
|
|
207,002
|
|
||
Total liabilities and stockholders’ equity
|
|
$
|
43,124,094
|
|
|
$
|
5,768,865
|
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2017
|
|
2016
|
|
2015
|
||||||
Revenues
|
|
|
|
|
|
|
||||||
License and other revenue
|
|
$
|
25,000,000
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Product revenue, net
|
|
1,910,403
|
|
|
—
|
|
|
—
|
|
|||
Sales force revenue
|
|
278,165
|
|
|
—
|
|
|
—
|
|
|||
Grant revenue
|
|
624,569
|
|
|
1,152,987
|
|
|
—
|
|
|||
Total revenues, net
|
|
27,813,137
|
|
|
1,152,987
|
|
|
—
|
|
|||
|
|
|
|
|
|
|
||||||
Operating expenses:
|
|
|
|
|
|
|
||||||
Cost of product sales
|
|
635,648
|
|
|
—
|
|
|
—
|
|
|||
Research and development
|
|
4,372,578
|
|
|
10,149,879
|
|
|
6,587,183
|
|
|||
General and administrative
|
|
7,941,584
|
|
|
7,083,155
|
|
|
4,422,764
|
|
|||
Sales and marketing
|
|
973,345
|
|
|
—
|
|
|
—
|
|
|||
Total operating expenses
|
|
13,923,155
|
|
|
17,233,034
|
|
|
11,009,947
|
|
|||
Income (loss) from operations
|
|
13,889,982
|
|
|
(16,080,047
|
)
|
|
(11,009,947
|
)
|
|||
Other income (expense):
|
|
|
|
|
|
|
||||||
Change in fair value of warrant liability, unit purchase option liability and investor rights obligation
|
|
(29,624
|
)
|
|
72,625
|
|
|
1,313,049
|
|
|||
Interest expense, net
|
|
(24,016
|
)
|
|
(464,181
|
)
|
|
(793,205
|
)
|
|||
Total other (expense) income
|
|
(53,640
|
)
|
|
(391,556
|
)
|
|
519,844
|
|
|||
Net income (loss) before taxes
|
|
13,836,342
|
|
|
(16,471,603
|
)
|
|
(10,490,103
|
)
|
|||
Income tax expense
|
|
1,966,519
|
|
|
—
|
|
|
—
|
|
|||
Net income (loss) after taxes
|
|
$
|
11,869,823
|
|
|
$
|
(16,471,603
|
)
|
|
$
|
(10,490,103
|
)
|
Net income (loss)
|
|
$
|
11,869,823
|
|
|
$
|
(16,471,603
|
)
|
|
$
|
(10,490,103
|
)
|
Net income (loss) attributable to common stockholders
|
|
$
|
7,772,084
|
|
|
$
|
(16,471,603
|
)
|
|
$
|
(10,490,103
|
)
|
Net income (loss) per share of common stock, basic
|
|
$
|
0.42
|
|
|
$
|
(1.87
|
)
|
|
(4.71
|
)
|
|
Net income (loss) per share of common stock, diluted
|
|
$
|
0.42
|
|
|
$
|
(1.87
|
)
|
|
(4.71
|
)
|
|
Weighted-average shares of common stock outstanding, basic
|
|
18,410,005
|
|
|
8,830,396
|
|
|
2,226,023
|
|
|||
Weighted-average shares of common stock outstanding, diluted
|
|
18,754,799
|
|
|
8,830,396
|
|
|
2,226,023
|
|
|
Series A, A-1 and B
|
|
Stockholders’ Equity (Deficit)
|
||||||||||||||||||||||||||
|
convertible preferred
|
|
|
|
|
|
Additional
|
|
|
|
|
|
Total
|
||||||||||||||||
|
stock
|
|
Common stock
|
|
paid‑in
|
|
Contingently issuable stock
|
|
Accumulated
|
stockholders’
|
|||||||||||||||||||
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
capital
|
|
Amount
|
|
deficit
|
|
equity (deficit)
|
||||||||||||||
Balance, January 1, 2015
|
99,139,637
|
|
|
$
|
28,345,531
|
|
|
649,721
|
|
|
$
|
650
|
|
|
$
|
16,742,063
|
|
|
$
|
—
|
|
|
$
|
(43,073,377
|
)
|
|
$
|
(26,330,664
|
)
|
Issuance of securities in initial public offering, including over-allotment and underwriters' unit purchase option, net of offering costs and underwriting discounts, commissions and expenses
|
—
|
|
|
—
|
|
|
4,020,000
|
|
|
4,020
|
|
|
21,161,569
|
|
|
—
|
|
|
—
|
|
|
21,165,589
|
|
||||||
Issuance of common stock for conversion of preferred stock upon closing of initial public offering
|
(99,139,637
|
)
|
|
(28,345,531
|
)
|
|
3,980,422
|
|
|
3,980
|
|
|
28,340,177
|
|
|
—
|
|
|
—
|
|
|
28,344,157
|
|
||||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
394,748
|
|
|
—
|
|
|
—
|
|
|
394,748
|
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(10,490,103
|
)
|
|
(10,490,103
|
)
|
||||||
Balance, December 31, 2015
|
—
|
|
|
$
|
—
|
|
|
8,650,143
|
|
|
$
|
8,650
|
|
|
$
|
66,638,557
|
|
|
—
|
|
|
$
|
(53,563,480
|
)
|
|
$
|
13,083,727
|
|
|
Issuance of common stock from sale of shares under common stock purchase agreement, net of offering costs
|
—
|
|
|
—
|
|
|
763,998
|
|
|
764
|
|
|
1,899,223
|
|
|
—
|
|
|
|
|
|
1,899,987
|
|
||||||
Shares purchased through employee stock purchase plan
|
—
|
|
|
—
|
|
|
20,000
|
|
|
20
|
|
|
(20
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,694,891
|
|
|
—
|
|
|
—
|
|
|
1,694,891
|
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(16,471,603
|
)
|
|
(16,471,603
|
)
|
||||||
Balance, December 31, 2016
|
—
|
|
|
$
|
—
|
|
|
9,434,141
|
|
|
$
|
9,434
|
|
|
$
|
70,232,651
|
|
|
—
|
|
|
$
|
(70,035,083
|
)
|
|
$
|
207,002
|
|
|
Issuance of common stock from sale of shares under common stock purchase agreement, net of offering costs
|
—
|
|
|
—
|
|
|
2,301,598
|
|
|
2,302
|
|
|
1,500,291
|
|
|
—
|
|
|
—
|
|
|
1,502,593
|
|
||||||
Issuance of preferred and common stock to Armistice Capital, net of offering costs
|
—
|
|
|
4
|
|
|
2,345,714
|
|
|
2,346
|
|
|
4,559,308
|
|
|
—
|
|
|
—
|
|
|
4,561,654
|
|
||||||
Conversion of Armistice Capital preferred to common stock
|
—
|
|
|
(4
|
)
|
|
11,940,000
|
|
|
11,940
|
|
|
(11,936
|
)
|
|
—
|
|
|
—
|
|
|
4
|
|
||||||
Issuance of shares in acquisition of TRx
|
—
|
|
|
|
|
5,184,920
|
|
|
5,185
|
|
|
5,853,770
|
|
|
—
|
|
|
—
|
|
|
5,858,955
|
|
|||||||
Contingently issuable stock in acquisition of TRx
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,655,464
|
|
|
—
|
|
|
2,655,464
|
|
||||||
Shares purchased through employee stock purchase plan
|
—
|
|
|
—
|
|
|
60,616
|
|
|
61
|
|
|
46,800
|
|
|
—
|
|
|
—
|
|
|
46,861
|
|
||||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,157,252
|
|
|
—
|
|
|
—
|
|
|
1,157,252
|
|
||||||
Net income
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
11,869,823
|
|
|
11,869,823
|
|
||||||
Balance, December 31, 2017
|
—
|
|
|
$
|
—
|
|
|
31,266,989
|
|
|
$
|
31,268
|
|
|
$
|
83,338,136
|
|
|
$
|
2,655,464
|
|
|
$
|
(58,165,260
|
)
|
|
$
|
27,859,608
|
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2017
|
|
2016
|
|
2015
|
||||||
Operating activities
|
|
|
|
|
|
|
||||||
Net income (loss)
|
|
$
|
11,869,823
|
|
|
$
|
(16,471,603
|
)
|
|
$
|
(10,490,103
|
)
|
Adjustments to reconcile net income (loss) provided by (used in) to net cash used in operating activities:
|
|
|
|
|
|
|
||||||
Depreciation and amortization
|
|
425,476
|
|
|
26,856
|
|
|
23,508
|
|
|||
Stock-based compensation expense
|
|
1,157,252
|
|
|
1,694,891
|
|
|
394,748
|
|
|||
Deferred taxes
|
|
(832,629
|
)
|
|
—
|
|
|
—
|
|
|||
Amortization of inventory fair value adjustment associated with acquisition of TRx
|
|
137,900
|
|
|
—
|
|
|
—
|
|
|||
Change in inventory reserve
|
|
178,346
|
|
|
—
|
|
|
—
|
|
|||
Non-cash interest expense
|
|
20,364
|
|
|
162,270
|
|
|
293,748
|
|
|||
Change in fair value of warrant liability, unit purchase option liability and investor rights obligation
|
|
29,624
|
|
|
(72,625
|
)
|
|
(1,313,049
|
)
|
|||
Changes in assets and liabilities:
|
|
|
|
|
|
|
||||||
Accounts receivable, net
|
|
(247,195
|
)
|
|
(132,472
|
)
|
|
—
|
|
|||
Other receivables
|
|
(427,241
|
)
|
|
—
|
|
|
—
|
|
|||
Inventory, net
|
|
(202,622
|
)
|
|
—
|
|
|
—
|
|
|||
Prepaid expenses and other assets
|
|
(177,691
|
)
|
|
22,047
|
|
|
(41,243
|
)
|
|||
Escrowed cash receivable
|
|
(3,752,390
|
)
|
|
—
|
|
|
—
|
|
|||
Restricted cash
|
|
(59,373
|
)
|
|
(15,107
|
)
|
|
116,666
|
|
|||
Accounts payable
|
|
96,065
|
|
|
332,100
|
|
|
(268,709
|
)
|
|||
Income taxes payable
|
|
2,259,148
|
|
|
—
|
|
|
—
|
|
|||
Accrued expenses and other liabilities
|
|
2,044,548
|
|
|
(119,495
|
)
|
|
1,121,054
|
|
|||
Net cash provided by (used in) operating activities
|
|
12,519,405
|
|
|
(14,573,138
|
)
|
|
(10,163,380
|
)
|
|||
Investing activities
|
|
|
|
|
|
|
||||||
Acquisition of business, net of cash acquired
|
|
(18,888,932
|
)
|
|
—
|
|
|
—
|
|
|||
Purchase of property and equipment
|
|
(23,325
|
)
|
|
(34,883
|
)
|
|
(19,984
|
)
|
|||
Net cash used in investing activities
|
|
(18,912,257
|
)
|
|
(34,883
|
)
|
|
(19,984
|
)
|
|||
Financing activities
|
|
|
|
|
|
|
||||||
Proceeds from ESPP stock sales
|
|
46,861
|
|
|
—
|
|
|
—
|
|
|||
Proceeds from Armistice Capital transaction
|
|
4,649,996
|
|
|
—
|
|
|
—
|
|
|||
Proceeds from sale of shares under common stock purchase agreement
|
|
1,693,498
|
|
|
2,003,182
|
|
|
|
||||
Principal payments on term debt
|
|
(2,374,031
|
)
|
|
(3,314,225
|
)
|
|
(1,811,744
|
)
|
|||
Payment of fractional shares upon conversion of preferred stock to common stock
|
|
4
|
|
|
—
|
|
|
(1,373
|
)
|
|||
Proceeds from initial public offering, including over-allotment, net of underwriting discounts, commissions and expenses
|
|
—
|
|
|
—
|
|
|
23,685,270
|
|
|||
Payment of offering costs
|
|
(279,247
|
)
|
|
(114,945
|
)
|
|
(2,269,171
|
)
|
|||
Net cash provided by (used in) financing activities
|
|
3,737,081
|
|
|
(1,425,988
|
)
|
|
19,602,982
|
|
|||
(Decrease) increase in cash and cash equivalents
|
|
(2,655,771
|
)
|
|
(16,034,009
|
)
|
|
9,419,618
|
|
|||
Cash and cash equivalents at beginning of period
|
|
5,127,958
|
|
|
21,161,967
|
|
|
11,742,349
|
|
|||
Cash and cash equivalents at end of period
|
|
$
|
2,472,187
|
|
|
$
|
5,127,958
|
|
|
$
|
21,161,967
|
|
Supplemental disclosures of cash flow information
|
|
|
|
|
|
|
||||||
Cash paid for interest
|
|
$
|
72,526
|
|
|
$
|
348,888
|
|
|
$
|
568,299
|
|
Cash paid for taxes
|
|
$
|
540,000
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Supplemental disclosures of non-cash financing activities
|
|
|
|
|
|
|
||||||
Issuance of common stock in TRx acquisition
|
|
$
|
5,858,955
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Contingently issuable shares in TRx acquisition
|
|
$
|
2,655,464
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
Year ended December 31,
|
||||||||||
Net income (loss) per share, basic and diluted calculation:
|
|
2017
|
|
2016
|
|
2015
|
||||||
Basic income (loss) per share
|
|
|
|
|
|
|
||||||
Net income (loss)
|
|
$
|
11,869,823
|
|
|
$
|
(16,471,603
|
)
|
|
$
|
(10,490,103
|
)
|
Undistributable earnings (loss) allocable to common shares
|
|
$
|
7,772,084
|
|
|
$
|
(16,471,603
|
)
|
|
$
|
(10,490,103
|
)
|
Undistributable earnings (loss) allocable to participating warrants
|
|
$
|
4,097,739
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
||||||
Weighted average shares, basic
|
|
|
|
|
|
|
||||||
Common stock
|
|
18,410,005
|
|
|
8,830,396
|
|
|
2,226,023
|
|
|||
Participating warrants
|
|
9,706,458
|
|
|
—
|
|
|
—
|
|
|||
|
|
28,116,463
|
|
|
8,830,396
|
|
|
2,226,023
|
|
|||
Basic income (loss) per share:
|
|
|
|
|
|
|
||||||
Common stock
|
|
$
|
0.42
|
|
|
$
|
(1.87
|
)
|
|
$
|
(4.71
|
)
|
Participating warrants
|
|
$
|
0.42
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
||||||
Diluted income (loss) per share:
|
|
|
|
|
|
|
||||||
Net income (loss) attributable to common shares
|
|
$
|
7,772,084
|
|
|
$
|
(16,471,603
|
)
|
|
$
|
(10,490,103
|
)
|
Net income (loss) reallocated
|
|
49,642
|
|
|
—
|
|
|
—
|
|
|||
Undistributed earnings (loss) allocable to common shares
|
|
$
|
7,821,726
|
|
|
$
|
(16,471,603
|
)
|
|
$
|
(10,490,103
|
)
|
|
|
|
|
|
|
|
||||||
Weighted average number of shares attributable to common shareholders - basic
|
|
18,410,005
|
|
|
8,830,396
|
|
|
2,226,023
|
|
|||
Effect of dilutive securities:
|
|
|
|
|
|
|
||||||
Stock options
|
|
61,510
|
|
|
—
|
|
|
—
|
|
|||
Contingently issuable shares
|
|
283,284
|
|
|
—
|
|
|
—
|
|
|||
Potentially dilutive shares
|
|
344,794
|
|
|
—
|
|
|
—
|
|
|||
Weighted average number of shares - diluted
|
|
18,754,799
|
|
|
8,830,396
|
|
|
2,226,023
|
|
|||
|
|
|
|
|
|
|
||||||
Diluted income (loss) per share
|
|
$
|
0.42
|
|
|
$
|
(1.87
|
)
|
|
$
|
(4.71
|
)
|
|
|
December 31,
|
|||||||
|
|
2017
|
|
2016
|
|
2015
|
|||
Stock options
|
|
2,812,006
|
|
|
1,849,359
|
|
|
959,188
|
|
Non-participating warrants on common stock
|
|
4,661,145
|
|
|
7,400,934
|
|
|
7,400,934
|
|
Underwriters' unit purchase option
|
|
40,000
|
|
|
40,000
|
|
|
40,000
|
|
|
|
At
|
||
|
|
November 17,
|
||
|
|
2017
|
||
|
|
|
||
Cash
|
|
$
|
18,900,000
|
|
Common stock (including contingently issuable shares)
|
|
8,514,419
|
|
|
Contingent payments
|
|
2,576,633
|
|
|
Total consideration transferred
|
|
$
|
29,991,052
|
|
|
|
At
|
||
|
|
November 17,
|
||
|
|
2017
|
||
Fair value of assets acquired:
|
|
|
||
Current assets:
|
|
|
||
Cash and cash equivalents
|
|
$
|
11,068
|
|
Accounts receivable, net
|
|
2,872,545
|
|
|
Inventory
|
|
495,777
|
|
|
Prepaid expenses and other current assets
|
|
134,281
|
|
|
Identifiable intangible assets
|
|
|
|
|
Acquired product marketing rights - Metafolin
|
|
10,465,000
|
|
|
PAI sales and marketing agreement
|
|
2,334,000
|
|
|
Acquired product marketing rights - Millipred
|
|
4,714,000
|
|
|
Acquired product marketing rights - Ulesfia
|
|
555,000
|
|
|
Total assets acquired
|
|
21,581,671
|
|
|
|
|
|
||
Fair value of liabilities assumed:
|
|
|
||
Accounts payable
|
|
192,706
|
|
|
Accrued expenses and other current liabilities
|
|
4,850,422
|
|
|
Deferred tax liability
|
|
839,773
|
|
|
Total liabilities assumed
|
|
5,882,901
|
|
|
Total identifiable net assets
|
|
15,698,770
|
|
|
Fair value of consideration transferred
|
|
29,991,052
|
|
|
Goodwill
|
|
$
|
14,292,282
|
|
|
|
At
|
||
|
|
November 17, 2017
|
||
|
|
|
||
Acquired product marketing rights - Metafolin
|
|
$
|
10,465,000
|
|
PAI Sales & Marketing Agreement
|
|
2,334,000
|
|
|
Acquired product marketing rights - Millipred
|
|
4,714,000
|
|
|
Acquired product marketing rights - Ulesfia
|
|
555,000
|
|
|
Fair value of identified intangible assets
|
|
$
|
18,068,000
|
|
|
|
Years Ended December 31,
|
||||||
|
|
2017
|
|
2016
|
||||
|
|
|||||||
Total revenues, net
|
|
$
|
43,602,212
|
|
|
$
|
19,586,923
|
|
Net income
|
|
$
|
14,564,584
|
|
|
$
|
(19,499,137
|
)
|
•
|
Level 1—inputs to the valuation methodology are quoted prices (unadjusted) for an identical asset or liability in an active market.
|
•
|
Level 2—inputs to the valuation methodology include quoted prices for a similar asset or liability in an active market or model‑derived valuations in which all significant inputs are observable for substantially the full term of the asset or liability.
|
•
|
Level 3—inputs to the valuation methodology are unobservable and significant to the fair value measurement of the asset or liability.
|
|
|
December 31, 2017
|
||||||||||
|
|
Fair Value Measurements Using
|
||||||||||
|
|
Quoted prices in
|
|
Significant other
|
|
Significant
|
||||||
|
|
active markets for
|
|
observable
|
|
unobservable
|
||||||
|
|
identical assets
|
|
inputs
|
|
inputs
|
||||||
|
|
(Level 1)
|
|
(Level 2)
|
|
(Level 3)
|
||||||
Assets
|
|
|
|
|
|
|
||||||
Investments in money market funds*
|
|
$
|
471,183
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Liabilities
|
|
|
|
|
|
|
||||||
Contingent consideration
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
2,576,633
|
|
Warrant liability
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
8,185
|
|
Unit purchase option liability
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
26,991
|
|
|
|
December 31, 2016
|
||||||||||
|
|
Fair Value Measurements Using
|
||||||||||
|
|
Quoted prices in
|
|
Significant other
|
|
Significant
|
||||||
|
|
active markets for
|
|
observable
|
|
unobservable
|
||||||
|
|
identical assets
|
|
inputs
|
|
inputs
|
||||||
|
|
(Level 1)
|
|
(Level 2)
|
|
(Level 3)
|
||||||
Assets
|
|
|
|
|
|
|
||||||
Investments in money market funds*
|
|
$
|
4,758,539
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Liabilities
|
|
|
|
|
|
|
||||||
Warrant liability
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
5,501
|
|
Unit purchase option liability
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
51
|
|
|
|
|
|
|
|
|
|
|
Warrant
|
|
Unit purchase
|
|
Contingent
|
|
|
||||||||
|
|
liability
|
|
option liability
|
|
consideration
|
|
Total
|
||||||||
Balance at December 31, 2016
|
|
$
|
5,501
|
|
|
$
|
51
|
|
|
$
|
—
|
|
|
$
|
5,552
|
|
Issuance of contingent consideration
|
|
—
|
|
|
—
|
|
|
2,576,633
|
|
|
2,576,633
|
|
||||
Change in fair value
|
|
2,684
|
|
|
26,940
|
|
|
—
|
|
|
29,624
|
|
||||
Balance at December 31, 2017
|
|
$
|
8,185
|
|
|
$
|
26,991
|
|
|
$
|
2,576,633
|
|
|
$
|
2,611,809
|
|
|
|
Warrant
|
|
Unit purchase
|
|
Investor rights
|
|
|
||||||||
|
|
liability
|
|
option liability
|
|
obligation
|
|
Total
|
||||||||
Balance at December 31, 2015
|
|
$
|
27,606
|
|
|
$
|
50,571
|
|
|
$
|
—
|
|
|
$
|
78,177
|
|
Change in fair value
|
|
(22,105
|
)
|
|
(50,520
|
)
|
|
—
|
|
|
(72,625
|
)
|
||||
Balance at December 31, 2016
|
|
$
|
5,501
|
|
|
$
|
51
|
|
|
$
|
—
|
|
|
$
|
5,552
|
|
|
|
December 31,
|
||||||
|
|
2017
|
|
2016
|
||||
Furniture and equipment
|
|
$
|
58,126
|
|
|
$
|
58,126
|
|
Computers and software
|
|
96,133
|
|
|
72,808
|
|
||
Total property and equipment
|
|
154,259
|
|
|
130,934
|
|
||
Less accumulated depreciation
|
|
(109,647
|
)
|
|
(87,691
|
)
|
||
Property and equipment, net
|
|
$
|
44,612
|
|
|
$
|
43,243
|
|
Goodwill balance at December 31, 2016
|
|
$
|
—
|
|
Goodwill from acquisition of TRx Pharmaceuticals
|
|
14,292,282
|
|
|
Goodwill balance at December 31, 2017
|
|
$
|
14,292,282
|
|
Intangible assets at December 31, 2016
|
|
$
|
0
|
|
|
Intangible assets from acquisition of TRx Pharmaceuticals
|
|
18,068,000
|
|
|
|
Intangible assets at December 31, 2017
|
|
$
|
18,068,000
|
|
|
|
|
December 31, 2017
|
|
|
||||||||||
|
|
|
|
|
|
|
|
|
||||||
|
|
Gross Carrying Amount
|
|
Accumulated Amortization
|
|
Net Carrying Amount
|
|
Weighted-Avg.Remaining Life
|
||||||
|
|
|
|
(in years)
|
||||||||||
Acquired product marketing rights
|
|
$
|
15,734,000
|
|
|
$
|
257,645
|
|
|
$
|
15,476,355
|
|
|
11.2
|
Sales and marketing agreement
|
|
2,334,000
|
|
|
145,875
|
|
|
2,188,125
|
|
|
1.9
|
|||
Total Intangible Assets
|
|
$
|
18,068,000
|
|
|
$
|
403,520
|
|
|
$
|
17,664,480
|
|
|
|
|
|
Estimated
|
||
|
|
Amortization
|
||
For the Years Ending December 31,
|
|
Expense
|
||
|
|
|
||
2018
|
|
$
|
3,228,167
|
|
2019
|
|
3,082,292
|
|
|
2020
|
|
2,038,030
|
|
|
2021
|
|
1,728,867
|
|
|
2022
|
|
697,667
|
|
|
Thereafter
|
|
6,889,457
|
|
|
Total amortization expense
|
|
$
|
17,664,480
|
|
|
|
December 31,
|
||||||
|
|
2017
|
|
2016
|
||||
Sales returns and allowances
|
|
$
|
4,146,217
|
|
|
$
|
—
|
|
Compensation and benefits
|
|
1,401,514
|
|
|
272,601
|
|
||
General and administrative
|
|
1,001,454
|
|
|
160,116
|
|
||
Royalties payable
|
|
743,010
|
|
|
—
|
|
||
Research and development expenses
|
|
299,480
|
|
|
315,937
|
|
||
Other
|
|
256,634
|
|
|
—
|
|
||
Accrued interest
|
|
—
|
|
|
193,781
|
|
||
Total accrued expenses and other current liabilities
|
|
$
|
7,848,309
|
|
|
$
|
942,435
|
|
|
|
December 31,
|
|
December 31,
|
||||
|
|
2017
|
|
2016
|
||||
Term loan
|
|
$
|
—
|
|
|
$
|
2,374,031
|
|
Less: debt discount
|
|
—
|
|
|
(20,364
|
)
|
||
Term Loan, net of debt discount
|
|
—
|
|
|
2,353,667
|
|
||
Less: current portion, net of debt discount
|
|
—
|
|
|
(2,353,667
|
)
|
||
Long term debt, net of current portion and debt discount
|
|
$
|
—
|
|
|
$
|
—
|
|
Number of shares
|
|
Exercise price
|
|
Expiration
|
||
underlying warrants
|
|
per share
|
|
date
|
||
80,966
|
|
$
|
28.00
|
|
|
August 2018
|
4,551,900
|
|
$
|
4.55
|
|
|
October 2018
|
40,000*
|
|
$
|
5.23
|
|
|
October 2018
|
3,571
|
|
$
|
28.00
|
|
|
December 2018
|
22,328*
|
|
$
|
8.40
|
|
|
October 2020
|
2,380*
|
|
$
|
8.68
|
|
|
May 2022
|
14,285,714
|
|
$
|
0.40
|
|
|
June 2022
|
18,986,859
|
|
|
|
|
||
|
|
|
|
|
||
*Accounted for as a liability instrument (see Note 5)
|
|
|
|
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2017
|
|
2016
|
|
2015
|
||||||
Research and development
|
|
$
|
156,047
|
|
|
$
|
141,247
|
|
|
$
|
67,021
|
|
General and administrative
|
|
1,001,205
|
|
|
1,553,644
|
|
|
327,727
|
|
|||
Total stock-based compensation
|
|
$
|
1,157,252
|
|
|
$
|
1,694,891
|
|
|
$
|
394,748
|
|
|
|
Options Outstanding
|
|||||||||||
|
|
Number of shares
|
|
Weighted average exercise price
|
|
Grant date fair value of options
|
|
Weighted average remaining contractual term (in years)
|
|||||
Balance, January 1, 2016
|
|
959,188
|
|
|
$
|
7.68
|
|
|
|
|
|
7.51
|
|
Granted
|
|
915,242
|
|
|
$
|
3.35
|
|
|
$
|
2,155,234
|
|
|
|
Forfeited
|
|
(25,071
|
)
|
|
$
|
5.04
|
|
|
|
|
|
|
|
Balance, December 31, 2016
|
|
1,849,359
|
|
|
$
|
5.57
|
|
|
|
|
|
8.44
|
|
Granted
|
|
1,020,377
|
|
|
$
|
0.94
|
|
|
$
|
669,816
|
|
|
|
Forfeited
|
|
(46,247
|
)
|
|
$
|
3.57
|
|
|
|
|
|
|
|
Balance, December 31, 2017
|
|
2,823,489
|
|
|
$
|
3.93
|
|
|
|
|
|
7.29
|
|
Vested and expected to vest at December 31, 2017
|
|
2,823,489
|
|
|
$
|
3.93
|
|
|
|
|
|
7.29
|
|
Exercisable at December 31, 2017
|
|
1,762,908
|
|
|
$
|
5.02
|
|
|
|
|
|
6.16
|
|
|
Year Ended December 31,
|
||||||||||||||||||||||
|
|
2017
|
|
2016
|
|
2015
|
||||||||||||||||||
Risk-free interest rate
|
|
1.85
|
%
|
|
—
|
|
2.38
|
%
|
|
1.01
|
%
|
|
—
|
|
1.93
|
%
|
|
1.64
|
%
|
|
—
|
|
1.97
|
%
|
Expected term of options (in years)
|
|
5.0
|
|
|
—
|
|
6.25
|
|
|
5.0
|
|
|
—
|
|
6.25
|
|
|
5.00
|
|
|
—
|
|
6.25
|
|
Expected stock price volatility
|
|
55
|
%
|
|
—
|
|
100.0
|
%
|
|
80.00
|
%
|
|
—
|
|
100.0
|
%
|
|
|
|
|
|
70.0
|
%
|
|
Expected annual dividend yield
|
|
—
|
%
|
|
—
|
|
—
|
%
|
|
—
|
%
|
|
—
|
|
—
|
%
|
|
—
|
%
|
|
—
|
|
—
|
%
|
•
|
Risk‑free interest rate: The Company bases the risk‑free interest rate on the interest rate payable on U.S. Treasury securities in effect at the time of grant for a period that is commensurate with the assumed expected option term.
|
•
|
Expected term of options: Due to lack of sufficient historical data, the Company estimates the expected life of its stock options granted to employees and members of the board of directors as the arithmetic average of the vesting term and the original contractual term of the option. The Company estimates the expected life of its stock options granted to consultants and nonemployees to be the contractual term of the options.
|
•
|
Expected stock price volatility: The Company estimated the expected volatility based on actual historical volatility of the stock price of other publicly‑traded biotechnology companies engaged in lines of business that are the same or similar to the Company’s. The Company calculated the historical volatility of the selected companies by using daily closing prices over a period of the expected term of the associated award. The companies were selected based on their enterprise value, risk profiles, position within the industry, and with historical share price information sufficient to meet the expected term of the associated award. A decrease in the selected volatility would decrease the fair value of the underlying instrument.
|
•
|
Expected annual dividend yield: The Company estimated the expected dividend yield based on consideration of its historical dividend experience and future dividend expectations. The Company has not historically declared or paid dividends to stockholders. Moreover, it does not intend to pay dividends in the future, but instead expects to retain any earnings to invest in the continued growth of the business. Accordingly, the Company assumed and expected dividend yield of
0.0%
.
|
|
|
2017
|
|
2016
|
|
2015
|
||||||
Current:
|
|
|
|
|
|
|
||||||
Federal
|
|
$
|
2,309,285
|
|
|
$
|
—
|
|
|
$
|
—
|
|
State
|
|
489,863
|
|
|
—
|
|
|
—
|
|
|||
|
|
2,799,148
|
|
|
—
|
|
|
—
|
|
|||
|
|
|
|
|
|
|
||||||
Deferred:
|
|
|
|
|
|
|
||||||
Federal
|
|
(789,274
|
)
|
|
—
|
|
|
—
|
|
|||
State
|
|
(43,355
|
)
|
|
—
|
|
|
—
|
|
|||
|
|
(832,629
|
)
|
|
—
|
|
|
—
|
|
|||
Net Income Tax Expense
|
|
$
|
1,966,519
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
December 31,
|
||||||
|
|
2017
|
|
2016
|
||||
Deferred tax assets:
|
|
|
|
|
||||
Net operating losses
|
|
$
|
716,819
|
|
|
$
|
20,587,955
|
|
Research and development credits
|
|
—
|
|
|
1,840,505
|
|
||
Deferred rent
|
|
4,051
|
|
|
11,902
|
|
||
Accrued compensation
|
|
271,437
|
|
|
90,936
|
|
||
Stock-based compensation
|
|
1,291,230
|
|
|
2,169,070
|
|
||
Other reserves
|
|
72,881
|
|
|
—
|
|
||
Basis difference in tangible and intangible assets
|
|
2,554,924
|
|
|
6,174,163
|
|
||
Total deferred tax assets
|
|
4,911,342
|
|
|
30,874,531
|
|
||
Deferred tax liabilities:
|
|
|
|
|
||||
Basis difference in intangible assets
|
|
(535,652
|
)
|
|
—
|
|
||
Installment sale
|
|
(358,844
|
)
|
|
—
|
|
||
Total deferred tax liabilities
|
|
(894,496
|
)
|
|
—
|
|
||
Deferred tax asset, net
|
|
4,016,846
|
|
|
30,874,531
|
|
||
Less valuation allowance
|
|
(4,023,990
|
)
|
|
(30,874,531
|
)
|
||
Net deferred taxes
|
|
$
|
(7,144
|
)
|
|
$
|
—
|
|
|
|
December 31,
|
|||||||
|
|
2017
|
|
2016
|
|
2015
|
|||
Federal statutory rate
|
|
34.00
|
%
|
|
34.00
|
%
|
|
34.00
|
%
|
Permanent differences
|
|
0.02
|
%
|
|
(0.02
|
)%
|
|
(0.02
|
)%
|
Warrants
|
|
0.07
|
%
|
|
0.15
|
%
|
|
4.26
|
%
|
Acquisition costs
|
|
0.08
|
%
|
|
—
|
%
|
|
—
|
%
|
Built in loss
|
|
1.52
|
%
|
|
—
|
%
|
|
—
|
%
|
State taxes
|
|
27.91
|
%
|
|
3.44
|
%
|
|
5.12
|
%
|
Research and development credit
|
|
(1.04
|
)%
|
|
2.18
|
%
|
|
2.69
|
%
|
Change in statutory rate due to Tax Cuts and Job Act
|
|
15.82
|
%
|
|
—
|
%
|
|
—
|
%
|
NOL adjustment per § 382
|
|
126.82
|
%
|
|
—
|
%
|
|
—
|
%
|
Other
|
|
0.04
|
%
|
|
—
|
%
|
|
0.03
|
%
|
Change in valuation allowance
|
|
(191.03
|
)%
|
|
(39.75
|
)%
|
|
(46.08
|
)%
|
Effective income tax rate
|
|
14.21
|
%
|
|
—
|
%
|
|
—
|
%
|
Year ending December 31,
|
|
||
2018
|
$
|
158,716
|
|
2019
|
—
|
|
|
|
$
|
158,716
|
|
|
|
Three Months Ended
|
|||||||||||||||
|
|
March 31,
|
|
June 30,
|
|
September 30,
|
|
December 31,
|
|||||||||
|
|
2017
|
|
2017
|
|
2017
|
|
2017
|
|||||||||
|
|
|
|
|
|
|
|
|
|||||||||
|
|
(in thousands, except per share data)
|
|||||||||||||||
License and other revenue
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
25,000
|
|
|
$
|
—
|
|
|
Product revenue, net
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,911
|
|
|||||
Sales force revenue
|
|
—
|
|
|
—
|
|
|
—
|
|
|
278
|
|
|||||
Grant revenue
|
|
384
|
|
|
158
|
|
|
38
|
|
|
45
|
|
|||||
Operating expenses:
|
|
|
|
|
|
|
|
|
|||||||||
Cost of product sales
|
|
—
|
|
|
—
|
|
|
—
|
|
|
636
|
|
|||||
Research and development
|
|
953
|
|
|
494
|
|
|
965
|
|
|
1,961
|
|
|||||
General and administrative
|
|
1,330
|
|
|
1,439
|
|
|
2,152
|
|
|
3,021
|
|
|||||
Sales and marketing
|
|
—
|
|
|
—
|
|
|
—
|
|
|
973
|
|
|||||
Change in fair value of warrant liability and unit purchase option liability
|
|
(4
|
)
|
|
2
|
|
|
—
|
|
|
(28
|
)
|
|||||
Interest (expense) income, net
|
|
(58
|
)
|
|
(26
|
)
|
|
29
|
|
|
31
|
|
|||||
Net (loss) income after taxes
|
|
$
|
(1,961
|
)
|
|
$
|
(1,799
|
)
|
|
$
|
18,721
|
|
|
$
|
(3,091
|
)
|
|
Net (loss) income per share of common stock, basic
|
|
$
|
(0.19
|
)
|
|
$
|
(0.14
|
)
|
|
$
|
0.52
|
|
|
$
|
(0.11
|
)
|
|
Net (loss) income per share of common stock, diluted
|
|
$
|
(0.19
|
)
|
|
$
|
(0.14
|
)
|
|
$
|
0.52
|
|
—
|
|
$
|
(0.11
|
)
|
|
|
Three Months Ended
|
||||||||||||||
|
|
March 31,
|
|
June 30,
|
|
September 30,
|
|
December 31,
|
||||||||
|
|
2016
|
|
2016
|
|
2016
|
|
2016
|
||||||||
|
|
|
|
|
|
|
|
|
||||||||
|
|
(in thousands, except per share data)
|
||||||||||||||
Operating expenses:
|
|
|
|
|
|
|
|
|
||||||||
Research and development
|
|
$
|
2,293
|
|
|
$
|
2,502
|
|
|
$
|
4,582
|
|
|
$
|
773
|
|
General and administrative
|
|
2,649
|
|
|
1,636
|
|
|
1,703
|
|
|
1,095
|
|
||||
Change in fair value of warrant liability, unit purchase option liability and investor rights obligation
|
|
(47
|
)
|
|
91
|
|
|
(101
|
)
|
|
130
|
|
||||
Interest income (expense), net
|
|
(151
|
)
|
|
(127
|
)
|
|
(104
|
)
|
|
(83
|
)
|
||||
Net loss
|
|
$
|
(5,140
|
)
|
|
$
|
(3,524
|
)
|
|
$
|
(6,169
|
)
|
|
$
|
(1,639
|
)
|
Net loss per share of common stock, basic and diluted
|
|
$
|
(0.59
|
)
|
|
$
|
(0.41
|
)
|
|
$
|
(0.70
|
)
|
|
$
|
(0.18
|
)
|
400 East Pratt Street
Suite 606
Baltimore, MD 21202
|
Entity Name
|
Jurisdiction
|
TRx Pharmaceuticals, LLC
|
North Carolina
|
Zylera Pharmaceuticals, LLC
|
North Carolina
|
Zylera Pharma Corp.
|
North Carolina
|
Consent of Independent Registered Public Accounting Firm
|
We consent to the incorporation by reference in the following Registration Statements:
(1)
Registration Form (Form S-8 No. 333-207949) pertaining to the 2015 Omnibus Incentive Compensation Plan,
(2)
Registration Statement on (Form S-8 No. 333-211490) pertaining to the 2016 Equity Incentive Plan,
(3)
Registration Statement on (Form S-8 No. 333-211491) pertaining to the 2016 Employee Stock Purchase Plan,
(4)
Registration Statement on (Form S-1 No. 333-211491) as filed on September 16, 2016, and
(5)
Registration Statement on (Form S-3 No. 333-214507) as filed on November 8, 2016;
of our report dated April 2, 2018, with respect to the consolidated financial statements of Cerecor Inc. included in this Annual Report (Form 10-K) for the year ended December 31, 2017.
|
|
1.
|
I have reviewed this Annual Report on Form 10-K of Cerecor Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Date: April 2, 2018
|
/s/ Peter Greenleaf
|
|
Peter Greenleaf
Chief Executive Officer
(Registrant’s Principal Executive Officer)
|
|
|
1.
|
I have reviewed this Annual Report on Form 10-K of Cerecor Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Date: April 2, 2018
|
/s/ Mariam E. Morris
|
|
Mariam E. Morris
Chief Financial Officer
(Registrant’s Principal Financial and Accounting Officer)
|
|
|
1.
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
|
2.
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Registrant.
|
Date: April 2, 2018
|
By:
|
/s/ Peter Greenleaf
|
|
Name:
|
Peter Greenleaf
|
|
Title:
|
Chief Executive Officer
(Registrant’s Principal Executive Officer)
|
|
|
|
Date: April 2, 2018
|
By:
|
/s/ Mariam E. Morris
|
|
Name:
|
Mariam E. Morris
|
|
Title:
|
Chief Financial Officer
(Registrant’s Principal Financial and Accounting Officer)
|
|