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•	the success, cost and timing of our clinical trials;

•	the expected benefits and growth potential of HOTSHOT;

•	our ability to obtain and maintain regulatory approval of our drug product candidates, and any related restrictions, limitations, and/or warnings in the label of an approved drug product candidate;

•	our ability to obtain funding for our operations, including funding necessary to complete clinical development and file a new drug application for drug product candidates;

•	any potential impact from the announcement that we are conducting a review of strategic alternatives for our consumer business segment;

•	our ability to expand the sales of our consumer product;

•	our plans to develop our drug product candidates;

•	our ability to attract collaborators with development, regulatory and commercialization expertise;

•	the size and growth potential of the markets for our consumer product and our drug product candidates, and our ability to serve those markets;

•	our ability to develop sales and marketing capabilities, whether alone or with potential future collaborators;

•	the rate and degree of market acceptance of our consumer product and our drug product candidates;

•	regulatory developments in the United States and foreign countries;

•	the performance of our third-party suppliers and manufacturers;

•	the success of competing therapies that are, or become, available;

•	the loss of key scientific or management personnel;

•	our expectations regarding the period during which we qualify as an emerging growth company under the Jumpstart Our Business Startups Act;

•	the accuracy of our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and

•	our expectations regarding our ability to obtain and adequately maintain sufficient intellectual property protection for our consumer product and drug product candidates.

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Advance FLX-787 for treatment across severe neurological conditions with significant unmet need. FLX-787 is currently being evaluated in three clinical trials in three neurological conditions. Our Australian Phase 2 exploratory MS clinical trial is a randomized, blinded, placebo-controlled cross-over clinical trial in patients suffering from cramps, spasms and spasticity associated with MS. The COMMEND and COMMIT clinical trials are randomized, controlled, double-blinded, parallel designed trials studying patients with MND and CMT who suffer from muscle cramps. We believe that there is opportunity to address a significant unmet need in each of these indications. It is estimated that 84% of MS patients experience spasticity while many ALS patients experience painful muscle cramps at some point in their disease progression and a large majority of CMT patients experience muscle cramps, which can be frequent.

•	Drive adoption and recurring use of HOTSHOT for the prevention and treatment of EAMCs and expand usage occasions to include helping to reduce muscle soreness and muscle pain. We are

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Collaborate selectively to augment and accelerate the research and development of our drug product candidates. We may seek third-party collaborators for the development and eventual commercialization of any drug product candidate we develop. In particular, we may enter into third-party arrangements for targeted neurological indications in which our potential collaborator has particular expertise or for which we need access to additional markets and research, development or commercialization resources.

•	Explore strategic alternatives for our consumer business segment. On January 22, 2018, we disclosed that we hired an investment banking firm to help us explore strategic alternatives for our consumer business segment.

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Expand development to additional indications. Based upon our research and development efforts, we believe that there are additional indications that we can address through the use of our chemical neurostimulation technology, such as dysphagia, or difficulty swallowing, in ALS and other indications, as well as cramping in renal failure patients during or between dialysis sessions. We expect to begin development efforts in these indications in 2018.

•	Evaluate the acquisition or in-licensing of product candidates. We may enhance our product pipeline through strategically acquiring or in-licensing pre-clinical or clinical stage product candidates. We believe that our management team and scientific advisory board's expertise may make us an attractive partner.

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•	FLX-787 showed a median 31% reduction in cramp frequency from baseline versus 0.1% reduction for patients while on placebo control;

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•	Patients had a median 4.4 cramp free days versus 0 for placebo control;

•	Patients evaluated themselves as improved with FLX-787 treatment 50% of the time versus 12.5% with placebo control (PGIC); and

•	Clinicians blinded to treatments evaluated 50% of patients as improved with FLX-787 versus 0% for placebo control (CGIC).

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•	84% reported that they felt less muscle soreness;

•	92% reported that they felt less muscle pain; and

•	88% said their next day workouts were better because they felt less muscle soreness

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•	completion of pre-clinical laboratory tests, animal studies and formulation studies according to Good Laboratory Practices, or GLP, or other applicable regulations;

•	submission to the FDA of an IND application, which must become effective before human clinical trials may begin;

•	approval by an IRB at each clinical site before each trial may be initiated;

•	performance of adequate and well-controlled human clinical trials according to the FDA's laws and regulations pertaining to the conduct of human clinical studies, collectively referred to as Good Clinical Practices, or GCP, and according to the International Council for Harmonization, or ICH, GCP guidelines, to establish the safety and efficacy of the proposed drug for its intended use;

•	submission to the FDA of a new drug application, or NDA, for a proposed new drug;

•	satisfactory completion of an FDA inspection of the manufacturing facility or facilities where the drug is produced to assess compliance with the FDA's requirements for current good manufacturing practices, or cGMP, to assure that the facilities, methods and controls are adequate to preserve the drug's identity, strength, quality and purity;

•	potential FDA audit of the non-clinical and clinical trial sites that generated the data in support of the NDA; and

•	FDA review and approval of the NDA prior to any commercial marketing, sale or shipment of the drug.

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Phase 1.    The drug is initially introduced into healthy human subjects and tested for safety, dosage tolerance, absorption, metabolism, distribution and excretion. In the case of some products for severe or life-threatening diseases, especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted only in patients having the specific disease.

•	Phase 2.    The drug is evaluated in a limited patient population to identify possible adverse events and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance, optimal dosage and dosing schedule for patients having the specific disease.

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Phase 3.    The drug is administered to an expanded patient population in adequate and well-controlled clinical trials to generate sufficient data to statistically confirm the efficacy and safety of the product for approval, to establish the overall risk-benefit profile of the product, and to provide adequate information for the labeling of the product. Generally, at least two adequate and well-controlled Phase 3 clinical trials are required by the FDA for approval of an NDA. In some cases, the FDA has approved a drug based on the results of a single adequate and well-controlled Phase 3 study of excellent design and which provided highly reliable and statistically strong evidence of important clinical benefit, such as an effect on survival, and a confirmatory study would have been difficult to conduct on ethical grounds.

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•	the timing and size of any future clinical trials and our ability to successfully complete them in a timely manner;

•	the number of indications that we pursue for our drug product candidates;

•	our ability to obtain approval from the FDA to market our product candidates;

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•	market acceptance of any drug product candidates, if approved;

•	the cost and timing of establishing sales, marketing and distribution capabilities;

•	the cost of our research and development activities;

•	the ability to obtain coverage and adequate reimbursement by third-party payors;

•	the cost and timing of marketing authorization or regulatory clearances;

•	the cost of goods associated our drug product candidates;

•	the impact of our assessment and implementation of strategic alternatives for our consumer business segment; and

•	the extent to which we acquire or invest in businesses, products and technologies, including entering into licensing or collaboration arrangements for product candidates.

•	significantly delay, scale back or discontinue the development or commercialization of our drug product candidates;

•	seek corporate partners for our drug product candidates at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available;

•	relinquish or license on unfavorable terms, our rights to technologies or drug product candidates or consumer products that we otherwise would seek to develop or commercialize ourselves; or

•	significantly curtail, or cease, operations.

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•	undertaking pre-clinical development and clinical trials;

•	hiring additional personnel;

•	formulating and manufacturing products, including stability testing for any drug product candidate;

•	obtaining regulatory approval;

•	initiating and conducting sales and marketing activities;

•	obtaining coverage and adequate reimbursement from third-party payors; and

•	implementing additional internal systems and infrastructure.

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•	the ability to create and maintain brand loyalty from our customers;

•	marketing HOTSHOT to endurance athletes and expanding our targeted customers to a broader audience;

•	entering into distribution and other strategic arrangements with third-party retailers and other potential distributors of our products; and

•	developing new product lines and extensions.

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•	failure to obtain regulatory approval to commence a trial;

•	failure to obtain independent IRB approval at each trial site;

•	addition of new trial sites;

•	unforeseen safety issues;

•	determination of dosing or formulation issues;

•	lack of effectiveness during later-stage clinical trials;

•	inability to reach agreement on acceptable terms with prospective contract research organizations, or CROs, and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

•	slower than expected rates of patient recruitment or failure to recruit suitable patients to participate in a trial;

•	failure to manufacture sufficient quantities of a drug candidate for use in clinical trials;

•	inability to monitor patients adequately during or after treatment, including failure to have patients complete a trial or return for post-treatment follow-up; and

•	inability or unwillingness of clinical investigators to follow our clinical protocols.

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•	we may not be able to demonstrate that our drug product candidates are safe and effective as treatments for our targeted indications to the satisfaction of the FDA or comparable foreign regulatory authorities;

•	the results of our clinical trials may not meet the level of statistical or clinical significance required by the FDA or comparable foreign regulatory authorities for marketing approval;

•	the FDA or comparable foreign regulatory authorities may disagree with the number, design, size, conduct or implementation of our clinical trials;

•	the CRO that we retain to conduct clinical studies and trials may take actions outside of our control that materially adversely impact our clinical studies and trials;

•	the FDA or comparable foreign regulatory authorities may not find the data from pre-clinical and clinical studies sufficient to demonstrate that the clinical and other benefits of our drug product candidates outweigh their safety risks;

•	the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from our pre-clinical and clinical studies or may require that we conduct additional studies;

•	the data collected from clinical trials of our drug product candidates may not be sufficient to support the submission of an NDA or other submission or to obtain regulatory approval in the United States or elsewhere;

•	the FDA or comparable foreign regulatory authorities may not accept data generated at our clinical trial sites;

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•	if our NDA is reviewed by an advisory committee, the advisory committee may recommend against approval of our application or may recommend that the FDA require, as a condition of approval, additional pre-clinical studies or clinical studies, limitations on approved labeling or distribution and use restrictions;

•	the FDA may require development of a Risk Evaluation and Mitigation Strategy, or REMS, as a condition of approval;

•	the FDA or comparable foreign regulatory authorities may identify deficiencies in the manufacturing processes or facilities of our third-party manufacturers with which we contract for clinical or commercial supplies; or

•	the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.

•	regulatory authorities may withdraw approval for the drug products or impose restrictions on their distribution in the form of a modified REMS;

•	regulatory authorities may require additional labeling statements on the drug products such as warnings or contraindications;

•	we may be required to create a medication guide for the drug products outlining the risks of such side effects for distribution to patients;

•	we may be required to change the way the product is administered or conduct additional clinical studies;

•	we could be sued and held liable for harm caused to individuals;

•	we could elect to discontinue the sale of HOTSHOT; or

•	our reputation may suffer.

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•	issue a warning letter asserting that we are in violation of the law;

•	seek an injunction or impose civil or criminal penalties or monetary fines;

•	suspend or withdraw regulatory approval;

•	suspend any ongoing clinical trials;

•	impose restrictions on the marketing and/or manufacturing of the product, withdraw the product from the market or require mandatory product recalls;

•	refuse to approve pending applications or supplements to approved applications submitted by us;

•	seize or detain product or refuse to permit the import or export of the product; or

•	refuse to allow us to enter into supply contracts, including government contracts.

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•	developing drugs;

•	undertaking pre-clinical testing and clinical trials;

•	obtaining FDA and other regulatory approvals of drugs;

•	formulating and manufacturing drugs; and

•	launching, marketing and selling drugs.

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•	the efficacy and safety as demonstrated in clinical trials;

•	the timing of market introduction of the drug product candidate as well as competitive products;

•	the clinical indications for which the drug product candidate is approved;

•	acceptance by physicians, the medical community and patients of the drug product candidate as a safe and effective treatment;

•	the convenience of prescribing and initiating patients on the drug product candidate;

•	the potential and perceived advantages of such drug product candidate over alternative treatments;

•	the cost of treatment in relation to alternative treatments, including any similar generic treatments;

•	the availability of coverage and adequate reimbursement and pricing by third-party payors including government authorities;

•	relative convenience and ease of administration;

•	the prevalence and severity of adverse side effects; and

•	the effectiveness of sales and marketing efforts.

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•	an annual, non-deductible fee on any entity that manufactures or imports certain branded prescription drugs and biologic agents, apportioned among these entities according to their market share in certain government healthcare programs;

•	an increase in the rebates a manufacturer must pay under the Medicaid Drug Rebate Program to 23.1% and 13.0% of the average manufacturer price for branded and generic drugs, respectively;

•	a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50.0% point-of-sale discounts to negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer's outpatient drugs to be covered under Medicare Part D;

•	extension of manufacturers' Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations;

•	expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals and by adding new mandatory eligibility categories for certain individuals with income at or below 133.0% of the Federal Poverty Level, thereby potentially increasing manufacturers' Medicaid rebate liability;

•	expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program;

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new requirements under the federal Open Payments program, created under Section 6002 of ACA and its implementing regulations that certain 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) report annually to HHS information related to "payments or other transfers of value" made or distributed to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals and that applicable manufacturers and applicable group purchasing organizations report annually to HHS ownership and investment interests held by physicians (as defined above) and their immediate family members;

•	a new requirement to annually report drug samples that manufacturers and distributors provide to physicians;

•	expansion of healthcare fraud and abuse laws, including the federal civil False Claims Act and the Anti-Kickback Statute, new government investigative powers, and enhanced penalties for non-compliance;

•	a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research; and

•	establishment of a Center for Medicare Innovation at the Centers for Medicare & Medicaid Services to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending.

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•	managing our clinical trials effectively;

•	continuing the commercialization of HOTSHOT;

•	assessing strategic alternatives for our consumer business segment;

•	identifying, recruiting, maintaining, motivating and integrating additional employees;

•	managing our internal development efforts effectively while complying with our contractual obligations to other third parties;

•	improving our managerial, development, operational, sales and finance systems; and

•	developing our compliance infrastructure and processes to ensure compliance with complex regulations and industry standards regarding us and our product candidates.

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•	the degree and range of protection any patents will afford us against competitors, including whether third parties will find ways to design around our patent claims and make, use, sell, offer to sell or import competitive products without infringing our patents;

•	if and when patents will issue;

•	whether others will obtain patents claiming inventions similar to those covered by our patents and patent applications; or

•	whether we will need to initiate litigation or administrative proceedings in connection with patent rights, which may be costly regardless of whether we win or lose.

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•	negative results from, delays in commencing or completing, or terminating our clinical trials;

•	inability to obtain additional funding;

•	sales of our common stock by us or our stockholders in the future;

•	trading volume of our common stock;

•	failure to generate significant sales for HOTSHOT;

•	an announcement related to the outcome of our review of strategic alternatives for our consumer business segment;

•	any delay in filing an IND for any drug product candidate and any adverse development or perceived adverse development with respect to the FDA's review of that IND;

•	failure to successfully develop and commercialize our drug product candidates or consumer products;

•	changes in laws or regulations applicable to our consumer products or drug product candidates, including without limitation, coverage and reimbursement policies;

•	inability to obtain adequate product supply for our drug product candidates or consumer product, or the inability to do so at acceptable prices;

•	adverse regulatory decisions;

•	introduction of new products or technologies by our competitors;

•	failure to meet or exceed product development or financial projections we provide to the public;

•	failure to meet or exceed the estimates and projections of the investment community;

•	the perception of the pharmaceutical industry or conventional beverage industry by the public, legislatures, regulators and the investment community;

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•	announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us or our competitors;

•	disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies;

•	additions or departures of key scientific or management personnel;

•	significant lawsuits, including patent or stockholder litigation; and

•	changes in the market valuations of similar companies.

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•	authorizing the issuance of "blank check" preferred stock, the terms of which may be established and shares of which may be issued without stockholder approval;

•	limiting the removal of directors by the stockholders;

•	creating a staggered board of directors;

•	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.

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(1)	See Note 2 and Note 14 of our consolidated financial statements included elsewhere herein for an explanation of the method used to compute basic and diluted net loss per share of common stock and the weighted-average number of shares used in computation of the per share amounts.

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•	the Consumer Operations segment, which reflects the total revenue and costs and expenses for HOTSHOT and our consumer operations; and

•	the Drug Development segment, which reflects the costs and expenses related to our efforts to develop innovative and proprietary drug products to treat muscle cramps, spasms and spasticity associated with severe neurological conditions.

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$1.9 million decrease in clinical activities and related work, primarily related to studies or activities completed in the prior year or ramping down in the current year, such as the submission of our IND, costs related to the identification of our drug product candidate and development of our drug substance, offset by startup, formulation and production costs for our FLX-787 Phase 2 clinical trials in the United States, which commenced in 2017, and other related studies and activities;

•	$0.9 million decrease in stock-based compensation expense, related primarily to the revaluation of non-employee awards and option grants at lower valuations than the prior year due to decreased stock price;

•	$0.3 million decrease related to salaries and benefits as average headcount for research and development personnel decreased compared to the prior year;

•	$0.2 million decrease related to our Consumer Operations segment, related to reduced formulation work for HOTSHOT compared to the prior year;

•	$0.2 million decrease in consulting expenses as we increased the use of consultants to assist with our IND efforts, which we began in 2016 and completed in the first quarter of 2017; and

•	$0.1 million increase in rent expense due to entering into a new lease agreement in 2017 for our current corporate headquarters.

•	$1.5 million decrease in stock-based compensation expense, related primarily to the revaluation of non-employee awards and option grants at lower valuations than the prior year due to decreased stock price, as well as a stock option award modification in the prior year;

•	$0.8 million decrease related to salaries and benefits, as Consumer Operations and corporate headcount decreased from the prior year;

•	$0.3 million decrease in external consulting costs within our Consumer Operations segment due to decreased use of consultants;

•	$0.6 million of increased costs within our Consumer Operations segment for HOTSHOT print and digital media campaigns and sponsorship programs, as well as costs related to our branded website;

•	$0.4 million increase in consulting expenses to supplement our corporate personnel;

•	$0.1 million increase in rent expense due to the termination of our lease agreement for our office in New York, NY, as well as increase in rent expense due to entering into a new lease agreement for our current corporate headquarters; and

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•	$0.1 million increase related to 12 months of distribution costs for HOTSHOT sales in 2017, as the product launched during the second quarter of 2016.

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•	$7.5 million of increased costs related to clinical studies of various formulations of our extract formulation and drug product candidates, including FLX-787, in the United States, increased costs related to clinical studies of FLX-787 outside of the United States, IND-supporting activities for FLX-787, and the manufacture of clinical supply;

•	$0.6 million increase in consulting expenses to supplement Drug Development segment personnel due to increased activities;

•	$0.2 million increase related to our Consumer Operations segment for research and formulation of HOTSHOT;

•	$0.6 million decrease in personnel costs incurred by our Drug Development segment, primarily stock-based compensation expense, related to the to revaluation of non-employee awards and option grants at lower valuations than the prior year due to decreased stock price; and

•	$0.1 million decrease in other costs, primarily allocated insurance and office-related expenses.

•	$1.0 million of increased personnel costs incurred by our Consumer Operations segment, including salaries and other compensation-related costs such as stock-based compensation, due to hiring additional personnel to support the launch of HOTSHOT, and certain employee termination costs;

•	$0.6 million of increased corporate personnel costs, including salaries and other compensation-related costs, related to additional administrative personnel hired to support our growth and increased activities;

•	$0.6 million of increased external costs within our Consumer Operations segment related to developing our consumer brand and HOTSHOT, including brand development and strategy costs, and marketing and promotional costs for pre-launch and launch activities, as selling commenced in the second quarter of 2016;

•	$0.5 million of increased external consulting costs for our Consumer Operations segment, primarily related to supporting HOTSHOT launch activities;

•	$0.3 million increase in stock-based compensation expense, primarily related to employee stock option grants, partially offset by the revaluation of non-employee awards at lower valuations due to decreased stock price;

•	$0.2 million increase in legal and professional fees, mainly related to patents and related legal work; and

•	$0.2 million increase in other costs, primarily insurance and facility-related fees.

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•	receiving regulatory approval to conduct clinical trials;

•	successfully enrolling, and completing, clinical trials;

•	receiving marketing approvals from applicable regulatory authorities;

•	establishing arrangements with third-party manufacturers;

•	obtaining and maintaining patent and trade secret protection and regulatory exclusivity; and

•	launching commercial sales of our products, if and when approved, whether alone or in collaboration with others.

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(1)

Consists of our lease agreement for an approximate 7,200 square foot facility used for administrative, sales and marketing and research and development activities in Boston, Massachusetts. The Boston lease expires in August 31, 2019, and has a letter of credit in support of this lease in the amount of $126,595. On July 25, 2017, in conjunction with transitioning our consumer operations to Boston, we terminated our lease in New York, New York, which had been used to support our Consumer Operations segment sales and marketing personnel. As of the termination date, we had no remaining contractual obligations under that lease.

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•	Fair value of our common stock — Because our stock was not publicly traded prior to the completion of our IPO in February 2015, we estimated the fair value of our common stock, as discussed below. As a result of the completion of our IPO, our common stock is now valued by reference to the publicly-traded closing price of our common stock on the date of grant.

•	Risk-free interest rate — The risk-free interest rate is based on the yields of U.S. Treasury securities with maturities similar to the expected term of the options for each option group.

•	Expected term — The expected term represents the period that our stock-based awards are expected to be outstanding.

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Expected volatility — As we do not have a significant trading history for our common stock, the expected stock price volatility for our common stock was estimated by taking the volatility for industry peers over a period equivalent to the expected term of the stock option grants. We intend to continue to consistently apply this process using the same or similar public companies until a sufficient amount of historical information regarding the volatility of our own common stock price becomes available.

•	Expected dividend yield — We have never declared or paid any cash dividends and do not presently plan to pay cash dividends in the foreseeable future. Consequently, we used an expected dividend yield of zero.

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•	reduced disclosure about our executive compensation arrangements;

•	no non-binding stockholder advisory votes on executive compensation or golden parachute arrangements; and

•	exemption from the auditor attestation requirement in the assessment of our internal control over financial reporting.

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•	The Consumer Operations segment, which reflects the total revenue and costs and expenses related to HOTSHOT and the Company's consumer operations.

•	The Drug Development segment, which reflects the costs and expenses related to the Company's efforts to develop innovative and proprietary drug products to treat muscle cramps, spasms and spasticity associated with severe neurological conditions.

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(1)	Registration Statement (Form S-8 No. 333-201816) pertaining to the 2014 Equity Incentive Plan, 2015 Equity Incentive Plan and 2015 Employee Stock Purchase Plan of Flex Pharma, Inc.;

(2)	Registration Statement (Form S-8 No. 333-210283) pertaining to the 2015 Equity Incentive Plan and 2015 Employee Stock Purchase Plan of Flex Pharma, Inc.;

(3)	Registration Statement (Form S-8 No. 333-216534) pertaining to the 2015 Equity Incentive Plan and 2015 Employee Stock Purchase Plan of Flex Pharma, Inc.; and

(4)	Registration Statement (Form S-3 No. 333-210289) of Flex Pharma, Inc.;

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