S-1 1 d149128ds1.htm S-1
`
`Table of Contents
`
`As filed with the Securities and Exchange Commission on August 19, 2016.
`
`Registration No. 333-
`
`UNITED STATES
`SECURITIES AND EXCHANGE COMMISSION
`Washington, D.C. 20549
`
`FORM S-1
`REGISTRATION STATEMENT
`UNDER
`THE SECURITIES ACT OF 1933
`
`THAR PHARMACEUTICALS, INC.
`
`(Exact Name of Registrant as Specified in its Charter)
`
`Delaware
`(State or other jurisdiction of
`incorporation or organization)
`
`2834
`(Primary Standard Industrial
`Classification Code Number)
`150 Gamma Drive
`Pittsburgh, Pennsylvania 15238
`(412) 963-6800
`(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)
`
`42-1699306
`(I.R.S. Employer
`Identification Number)
`
`Raymond K. Houck
`Chief Executive Officer
`Thar Pharmaceuticals, Inc.
`150 Gamma Drive
`Pittsburgh, Pennsylvania 15238
`(412) 963-6800
`(Name, address, including zip code, and telephone number, including area code, of agent for service)
`
`Copies to:
`
`Stephen M. Davis
`Daniel Lang
`Goodwin Procter LLP
`620 8th Avenue
`New York, New York 10018
`(212) 813-8800
`
`Divakar Gupta
`Yvan-Claude Pierre
`Joshua Kaufman
`Cooley LLP
`1114 Avenue of the Americas
`New York, New York 10036
`(212) 479-6000
`
`Approximate date of commencement of proposed sale to public: As soon as practicable after this Registration Statement is
`declared effective.
`If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under
`the Securities Act of 1933, check the following box. ¨
`If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following
`box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ¨
`If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the
`Securities Act registration statement number of the earlier effective registration statement for the same offering. ¨
`If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the
`Securities Act registration statement number of the earlier effective registration statement for the same offering. ¨
`Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller
`reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the
`Exchange Act.
`Large accelerated filer ¨
`
`Accelerated filer
`
`¨
`
`ANTECIP EXHIBIT 2003
`Grunenthal GmbH v. Antecip Bioventures II LLC
`PGR2019-00028
`
`Page 1
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`

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`Non-accelerated filer
`
`x (Do not check if a smaller reporting company)
`CALCULATION OF REGISTRATION FEE
`
`Smaller reporting company ¨
`
`Common stock, $0.001 par value
`
`Title of each class of
`securities to be registered
`
`Proposed
`maximum
`aggregate
`offering price(1)
`$50,000,000
`
`Amount of
`registration fee(2)
`$5,035
`
`(1)
`
`Includes offering price of shares that the underwriters have the option to purchase to cover over-allotments, if any. Estimated solely for
`the purpose of calculating the registration fee in accordance with Rule 457(o) of the Securities Act of 1933, as amended.
`(2) Calculated pursuant to Rule 457(o) based on an estimate of the proposed maximum aggregate offering price.
`
`The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective
`date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter
`become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the Registration Statement shall become
`effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.
`
`Page 2
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`

`

`Table of Contents
`
`The information in this preliminary prospectus is not complete and may be changed. We may not sell these securities until the registration
`statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and it
`is not soliciting an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.
`
`Subject to Completion, dated August 19, 2016
`
`PROSPECTUS
`
` Shares
`
`Thar Pharmaceuticals, Inc.
`
`Common Stock
`
`This is the initial public offering of shares of common stock of Thar Pharmaceuticals, Inc. We are offering
` shares of our common stock. Prior to this offering, there has been no public market for our common stock. It is
`currently estimated that the initial public offering price per share will be between $ and $ . We have applied to
`have our common stock listed on the NASDAQ Global Market under the trading symbol “THAR.”
`
`We are an “emerging growth company” under applicable Securities and Exchange Commission rules and will
`be subject to reduced public company reporting requirements for this prospectus and future filings. See “Prospectus
`Summary—Implications of Being an Emerging Growth Company.”
`
`Investing in our common stock involves a high degree of risk. See “Risk Factors” beginning
`on page 11.
`
`Public offering price
`Underwriting discounts(1)
`Proceeds to us, before expenses
`
`Per
`Share
`
`$
`$
`$
`
`Total
`
`$
`$
`$
`
`(1)
`
`See “Underwriting” beginning on page 155 of this prospectus for additional disclosure regarding underwriting
`discounts, commissions and estimated expenses.
`
`The underwriters may also purchase up to an additional shares of common stock from us at the public
`offering price, less the underwriting discounts payable by us, to cover over-allotments, if any, within 30 days from the
`date of this prospectus.
`
`Neither the Securities and Exchange Commission nor any state securities commission has approved or
`disapproved of these securities or passed on the adequacy or accuracy of this prospectus. Any representation
`to the contrary is a criminal offense.
`
`The underwriters expect to deliver the shares against payment in New York, New York on or about
` , 2016.
`
`Page 3
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`

`

`SunTrust Robinson Humphrey
`
`Prospectus dated , 2016
`
`Page 4
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`

`

`Table of Contents
`
`TABLE OF CONTENTS
`
`PROSPECTUS SUMMARY
`RISK FACTORS
`CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
`INDUSTRY AND MARKET DATA
`USE OF PROCEEDS
`DIVIDEND POLICY
`CAPITALIZATION
`DILUTION
`SELECTED FINANCIAL DATA
`MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
`OPERATIONS
`BUSINESS
`MANAGEMENT
`EXECUTIVE COMPENSATION
`CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS
`PRINCIPAL STOCKHOLDERS
`DESCRIPTION OF CAPITAL STOCK
`SHARES ELIGIBLE FOR FUTURE SALE
`UNDERWRITING
`LEGAL MATTERS
`EXPERTS
`WHERE YOU CAN FIND MORE INFORMATION
`INDEX TO FINANCIAL STATEMENTS
`
`Page
`1
`11
`61
`63
`64
`65
`66
`68
`70
`
`72
`86
`119
`127
`136
`140
`143
`148
`155
`163
`163
`163
`F-1
`
`We are responsible for the information contained in this prospectus and in any free-writing prospectus
`we prepare or authorize. We have not, and the underwriters have not, authorized anyone to provide you with
`different information, and we take no responsibility for any other information others may give you. We are not,
`and the underwriters are not, making an offer to sell these securities in any jurisdiction where the offer or sale
`is not permitted. You should not assume that the information contained in this prospectus is accurate as of any
`date other than the date on the cover page of this prospectus. Our business, financial condition, results of
`operations and prospects may have changed since that date.
`
`i
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`Table of Contents
`
`PROSPECTUS SUMMARY
`
`This summary highlights information contained elsewhere in this prospectus and does not contain all of the
`information that you should consider in making your investment decision. Before investing in our common stock, you
`should carefully read this entire prospectus, including our financial statements and the related notes thereto and the
`information set forth under the sections titled “Risk Factors,” “Cautionary Note Regarding Forward Looking
`Statements” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in each
`case included in this prospectus. Unless the context otherwise requires, we use the terms “Thar,” “Thar
`Pharmaceuticals,” “Company,” “we,” “us,” “our” and similar designations in this prospectus to refer to Thar
`Pharmaceuticals, Inc.
`
`Company Overview
`
`We are a clinical stage biopharmaceutical company focused on developing and commercializing a pipeline
`of novel, oral therapies designed to solve clinical limitations of existing intravenous-only therapies for serious and life
`threatening conditions. Using our proprietary Enhance technology platform, we are developing our lead product
`candidate, T121, for the management of pain associated with complex regional pain syndrome, or CRPS, a
`debilitating orphan condition. T121 is an orally-administered, zoledronic acid molecular complex, formulated as a
`delayed-release composition, that was granted Orphan Drug Designation by the U.S. Food and Drug Administration,
`or FDA, in April 2015 for the treatment of CRPS. We plan to further utilize our Enhance technology to create a
`pipeline of novel, patentable oral product candidates by modifying the relevant physicochemical properties of
`intravenous-only and other approved drugs to improve pharmacokinetics and performance of the original drug.
`
`Our lead product candidate, T121, is a novel, non-opioid, oral formulation of zoledronic acid for the
`management of pain associated with CRPS. Zoledronic acid is the most potent bisphosphonate, a class of drugs
`known to inhibit osteoclasts, which are key cells involved in the maintenance, repair and remodeling of bone.
`Zoledronic acid is currently approved in an intravenous, or IV, formulation in the United States for the treatment of
`bone-related disorders, including certain cancers metastatic to bone and osteoporosis. CRPS is a chronic,
`debilitating, pain disorder that affects the extremities for which there are currently no pharmacological therapies
`approved by the FDA or European Medicines Agency, or the EMA.
`
`We intend to utilize the FDA’s 505(b)(2) regulatory pathway to seek approval of T121 in the United States.
`To date, we have conducted eight nonclinical pharmacokinetic and toxicological studies with developmental
`formulations of T121 and one single dose, open-label, dose-escalation and formulation Phase 1 clinical trial in 71
`healthy, postmenopausal women. In our Phase 1 clinical trial, we observed, among other things, no serious adverse
`events or unexpected safety issues related to T121 relative to IV zoledronic acid and we identified a formulation and
`dosing regimen of T121 to investigate in our Phase 3 clinical trials. We plan to conduct two double-blind, placebo-
`controlled, multisite Phase 3 clinical trials with approximately 150 patients each to evaluate the safety and efficacy of
`T121 for the treatment of pain associated with CRPS. We anticipate initiating the first pivotal clinical trial in the first
`quarter of 2017.
`
`We retain worldwide rights for the development and commercialization of T121 with no royalty obligations to
`third parties. If we successfully complete our Phase 3 clinical trials and receive FDA approval, we intend to
`commercialize T121 in the United States through an approximately 50-person sales force targeting an estimated
`4,000 pain specialists who treat patients with CRPS. T121 is protected by a patent portfolio covering composition-of-
`matter and formulation claims in the United States until 2030. We believe that, if approved, T121 has the potential to
`provide potent and long-term pain relief in an oral formulation and address the significant unmet need in CRPS.
`
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`Table of Contents
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`Overview of CRPS
`
`CRPS is a chronic, regional pain disorder characterized by loss of motor function, changes in skin color and
`texture, bone demineralization and severe, debilitating pain, the intensity of which can exceed that of childbirth and
`kidney stones. CRPS typically manifests in an extremity, such as an arm or leg, following injury or trauma. Primary
`causes of CRPS include bone fracture, soft tissue injury and surgery. CRPS impairs daily functioning, negatively
`impacts quality of life and for many patients the pain and associated loss of function may lead to depression, suicidal
`ideation or development of other psychological disorders. Approximately 80,000 people in the United States are
`diagnosed with CRPS annually.
`
`There are no FDA or EMA approved pharmacological therapies for the treatment of CRPS or the pain
`associated with CRPS. Currently, a combination of common, off-label neuropathic pain therapies are administered,
`which may include anticonvulsants, tricyclic antidepressants, which are a group of drugs that affect certain
`chemicals in the nervous system and treat depression and other neurologic conditions, low to high-dose opioids and
`topical pain relief creams. Pain specialists will also treat CRPS patients with sympathetic nerve blocks. For CRPS
`patients who do not respond to drug therapy, invasive treatment options, such as spinal cord stimulation or
`intrathecal pain pumps, which are devices that deliver a drug directly to the spinal cord and nervous system, may be
`used. To date, no pharmacological therapy has been shown to effectively treat the pain associated with CRPS and
`current therapies have a number of limitations, including:
`
`•
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`•
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`•
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`•
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`limited efficacy of existing off-label therapies, which results in persistent CRPS symptoms, reduced
`functionality and impaired quality of life;
`
`the lack of an FDA or EMA approved drug therapy for CRPS, which results in trial-and-error treatment
`decisions that are based on physician preference and vary based on the experience of the prescribing
`physician;
`
`potential safety concerns and health risks associated with the chronic use of opioids; and
`
`certain therapies currently used to treat CRPS are administered intravenously, which makes them
`challenging to use in patients with limited access to infusion centers or in those who have difficulty
`receiving IV treatments.
`
`According to data published in the Oxford Journal of Rheumatology in 2012 and Nature Reviews Clinical
`Oncology in 2009, bisphosphonates reduce pain and inflammation in patients with CRPS and a variety of bone
`diseases. These studies have reported the efficacy of bisphosphonates in the treatment of pain associated with
`CRPS and demonstrated linear dose-dependent responses in pain reduction. Within these trials, zoledronic acid
`also showed the greatest pain reduction of any other bisphosphonate drug evaluated, consistent with its position as
`the most potent bisphosphonate.
`
`To better understand the market for the management of pain associated with CRPS, we engaged third
`parties to survey approximately 100 physicians who treat patients with CRPS and interview representatives of 13
`commercial third-party payors. This research indicated a significant unmet need for more effective management of
`pain associated with CRPS, as none of the current therapies used off label consistently provide meaningful
`analgesic relief. Surveyed physicians noted that a reduction of pain exceeding 30% would be considered a
`significant improvement over existing off-label treatment options. We believe that, if approved, T121 has the
`potential to provide potent and long-term pain relief in an oral formulation and address the significant unmet need in
`CRPS.
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`T121, Our Lead Product Candidate
`
`T121 is a zoledronic acid DL-lysine monohydrate molecular complex, formulated as a delayed-release
`composition, that has been shown to display similar biological effects as the currently approved IV formulation of
`zoledronic acid. If approved, we believe T121 will likely be the first oral therapy available to be marketed in the
`United States for the management of pain in CRPS patients and has the potential to be a best-in-class, first-line
`therapy in this indication. We believe T121 may be able to overcome a number of limitations of current off-label
`therapies by potentially providing:
`
`•
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`•
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`•
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`•
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`Potent analgesic effect. IV zoledronic acid is recognized as the most potent bisphosphonate in all
`indications in which it has been studied. In prior studies initiated and conducted independently by
`research physicians without our involvement, or investigator-initiated studies, IV zoledronic acid was
`observed to provide up to a 70% pain reduction, the most pain reduction compared to any other
`bisphosphonate reported in the CRPS literature. In our Phase 1 clinical trial, we observed that T121
`administration as an oral, delayed-release tablet formulation resulted in a similar exposure and
`pharmacological effect as IV zoledronic acid.
`
`Durable response. We believe that T121 has the potential to provide long-term pain relief for CRPS
`patients, which could lead to improved patient outcomes and maintained limb functionality. After IV
`administration of zoledronic acid, approximately 60% of the active drug remains in the body and is
`rapidly distributed to bone within the first 24 hours, with the remainder excreted in urine. The
`zoledronic acid distributed to bone is released gradually in a sustained but low systemic exposure,
`with an estimated terminal half-life of at least six months. In our Phase 1 clinical trial we observed a
`similar pharmacodynamic profile of T121 compared to that of IV zoledronic acid. We expect that T121
`will also have a prolonged terminal half-life, which we believe will lead to persistent clinical benefits.
`
`Oral dosing. We believe T121’s potential dosing regimen of three doses over a 29-day period has a
`number of advantages compared to IV formulations of other bisphosphonates, including patient
`convenience, comfort and mobility. In addition, oral formulations may reduce the costs of treating
`CRPS by reducing hospital admissions and the time pharmacists and nurses spend treating CRPS.
`
`Favorable safety profile. In our Phase 1 clinical trial, we observed no serious adverse events and no
`unexpected safety issues related to T121 relative to IV zoledronic acid. We believe T121 may have a
`similar safety profile to IV zoledronic acid, which has been administered to more than four million
`patients worldwide.
`
`Our Enhance Technology Platform
`
`Through our proprietary Enhance technology platform, we seek to identify and create a pipeline of novel,
`patentable oral drug therapies by modifying the relevant physicochemical properties of IV-only and other drugs.
`Specifically, we create a new active drug substance by bonding the original IV drug with a second molecule to form
`a molecular complex. The molecules that we choose to bond with the active ingredient of the original IV drug, which
`we refer to as pharmaceutically acceptable molecules, are often molecules that have been used in other drug
`products approved by the FDA. The new molecular complexes that we create may improve the pharmacokinetic and
`performance properties of the original drug. These improvements may allow our product candidates to be orally
`formulated when the original drug is formulated for IV-only use, or the improvements may solve additional clinical
`limitations of other existing therapies, including poor bioavailability, slow onset of action, high pharmacokinetic
`variability or poor tolerability. Using our Enhance technology, we are developing a pipeline of potential product
`candidates and programs, including treatments for acute pain, cancer and infectious disease.
`
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`Our Strategy
`
`Our goal is to become a leading biopharmaceutical company that develops and commercializes novel, oral
`therapies designed to solve clinical limitations of IV-only therapies for serious and life threatening conditions. The
`principal elements of our strategy to accomplish this goal are the following:
`
`continue to develop T121 and obtain United States and European Union regulatory approval;
`
`establish T121 as a best-in-class, first-line therapy for CRPS;
`
`build targeted sales and marketing infrastructure to maximize the commercial potential for T121 in the
`United States;
`
`use our Enhance technology to develop a pipeline of novel oral therapies in addition to T121;
`
`pursue drug development strategies targeting shorter development timelines and lower associated
`expenses; and
`
`explore other geographic and market opportunities for T121 and other product candidates that we may
`develop.
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`Team
`
`Our management and advisory team has extensive experience in drug and clinical development and orphan
`diseases. Members of our executive team have co-founded or been members of the management teams of
`successful pharmaceutical or scientific companies. In addition to experience across a range of management,
`finance, and operational fields, members of our executive team have knowledge and experience in orphan diseases
`and orphan drug development, including as core members of the medical and regulatory teams that successfully
`developed the orphan drug, Cinryze, which is used to treat hereditary angioedema. We maintain a distinguished
`board of advisors with experience in drug development and commercialization, many of whom were involved in the
`development of the original IV zoledronic acid at Novartis. Furthermore, we have built a team of world-class thought
`leaders in the treatment of CRPS patients to serve as our key opinion leaders. These advisors include the authors of
`the Budapest criteria, which are a set of objective guidelines used by physicians worldwide to diagnose CRPS. See
`“Executive Compensation—Compensation of our Key Opinion Leaders” for a summary of how we compensate our
`advisors.
`
`Risks Affecting Us
`
`Our business is subject to a number of risks and uncertainties, including those highlighted in the section
`titled “Risk Factors” immediately following this prospectus summary. Some of these risks are:
`
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`We have incurred significant losses since our inception, and anticipate that we will incur continued
`losses for the foreseeable future and thus may never achieve or maintain profitability.
`
`We have not generated any revenue from any commercial products and may never be profitable.
`
`We will need additional capital to support our growth, which may be difficult to obtain on terms
`favorable to us or our stockholders, if at all.
`
`We have a limited operating history and no history of commercializing products, which may make it
`difficult to evaluate our business and prospects.
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`We are substantially dependent on the success of our lead product candidate, T121, and cannot
`guarantee that T121 will successfully complete our planned Phase 3 clinical trials, receive regulatory
`approval or be successfully commercialized.
`
`Any negative clinical results from, termination or suspension of, or delays in the commencement or
`completion of, any necessary future trials of T121 for the treatment of pain associated with CRPS, in
`the United States or other countries, or future clinical trials of product candidates we may develop
`could result in increased costs to us, delay or limit our ability to generate revenue and negatively
`impact our commercial prospects.
`
`T121 or any future products we may develop may infringe the intellectual property rights of others,
`which could increase our costs and delay or prevent our development and commercialization efforts.
`
`T121 has received Orphan Drug Designation from the FDA. However, there is no guarantee that we
`will be able to maintain this designation for T121, receive this designation for any of our other potential
`product candidates, or receive or maintain any corresponding benefits, including periods of marketing
`exclusivity.
`
`We face significant competition from other pharmaceutical and biotechnology companies and they or
`others may also discover, develop or commercialize products before or more successfully than we do.
`
`If the manufacturers upon whom we rely fail to produce our product candidates in the volumes that we
`require on a timely basis or comply with stringent regulations, or if we are unable to establish or are
`delayed in establishing a manufacturing relationship for the manufacture of T121 needed for our
`second planned Phase 3 clinical trial, we may face delays in the development and commercialization
`of, or be unable to meet demand for, our products and may lose potential revenues.
`
`If we are unable to protect our intellectual property rights or if our intellectual property rights are
`inadequate to protect our technology, T121 or any future product candidates, our competitors could
`develop and commercialize technology and drugs similar to ours, and our competitive position could
`be harmed.
`
`An active trading market for our common stock may not develop, and you may not be able to sell your
`shares.
`
`Corporate Information
`
`Thar Pharmaceuticals was originally incorporated under the laws of the Commonwealth of Pennsylvania on
`January 17, 2006 as a wholly-owned subsidiary of Thar Technologies, Inc., or Thar Technologies, a Pennsylvania
`corporation. On January 1, 2007, Thar Technologies transferred and assigned the assets and liabilities of its
`pharmaceutical division to Thar Pharmaceuticals. On January 30, 2008, Thar Pharmaceuticals merged into a
`Delaware corporation of the same name, which was the surviving entity. On January 2, 2010, Thar Technologies
`was dissolved and its assets, including all shares of Thar Pharmaceuticals, were distributed to the shareholders of
`Thar Technologies.
`
`Our principal executive offices are located at 150 Gamma Drive, Pittsburgh, Pennsylvania 15238 and our
`telephone number is 412-963-6800. Our website address is www.tharpharma.com. The
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`
`information contained on our website, or that can be accessed through our website, is not a part of this prospectus
`and is not incorporated by reference into this prospectus. You should not rely on any such information in deciding
`whether to purchase our common stock.
`
`We own the unregistered trademark “Enhance.” All trademarks or trade names referred to in this prospectus
`are the property of their respective owners. Solely for convenience, the trademarks and trade names in this
`prospectus may be referred to without the ® and ™ symbols, but such references should not be construed as any
`indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto.
`We do not intend our use or display of other companies’ trademarks and trade names to imply a relationship with, or
`endorsement or sponsorship of us by, any other companies.
`
`Implications of Being an Emerging Growth Company
`
`As a company with less than $1 billion in revenue during our most recently completed fiscal year, we qualify
`as an “emerging growth company” as defined in Section 2(a) of the Securities Act of 1933, as amended, or the
`Securities Act, as modified by the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. As an emerging
`growth company, we may take advantage of specified reduced disclosure and other requirements that are otherwise
`applicable, in general, to public companies that are not emerging growth companies. These provisions include:
`
`•
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`reduced disclosure about our executive compensation arrangements;
`
`exemption from the non-binding stockholder advisory votes on executive compensation or golden
`parachute arrangements;
`
`exemption from the auditor attestation requirement in the assessment of our internal control over
`financial reporting; and
`
`reduced disclosure of financial information in this prospectus, such as being permitted to include only
`two years of audited financial information and two years of selected financial information in addition to
`any required unaudited interim financial statements, with correspondingly reduced “Management’s
`Discussion and Analysis of Financial Condition and Results of Operations” disclosure.
`
`We may take advantage of these exemptions for up to five years or such earlier time that we are no longer
`an emerging growth company. We would cease to be an emerging growth company if we have more than $1 billion
`in annual revenues as of the end of a fiscal year, have more than $700 million in market value of our capital stock
`held by non-affiliates as of the last day of our second fiscal quarter or if we issue more than $1 billion of non-
`convertible debt over a three-year-period. We may choose to take advantage of some, but not all, of the available
`exemptions. We have taken advantage of some reduced reporting burdens in this prospectus. Accordingly, the
`information contained herein may be different than the information you receive from other public companies in which
`you hold stock.
`
`The JOBS Act permits an emerging growth company to take advantage of an extended transition period to
`comply with new or revised accounting standards applicable to public companies. We have irrevocably elected not
`to avail ourselves of this extended transition period and, as a result, we will adopt new or revised accounting
`standards on the relevant dates on which adoption of such standards is required for non-emerging growth
`companies.
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`Table of Contents
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`THE OFFERING
`
`Common stock offered by us
`
` shares (or shares if the underwriters exercise
`their option to purchase additional shares in full).
`
`Common stock to be outstanding immediately after
`this offering
`
` shares (or shares if the underwriters exercise
`their option to purchase additional shares in full).
`
`Underwriters’ option to purchase additional shares We have granted a 30-day option to the underwriters to
`purchase up to an aggregate of additional shares of
`common stock.
`
`Use of proceeds
`
`Risk factors
`
`We estimate that the net proceeds from the issuance of our
`common stock in this offering will be approximately $
`million, or approximately $ million if the underwriters
`exercise their option to purchase additional shares in full,
`assuming an initial public offering price of $ per share,
`which is the midpoint of the price range set forth on the cover
`page of this prospectus, after deducting estimated
`underwriting discounts and commissions and estimated
`offering expenses payable by us.
`
`We intend to use the net proceeds from this offering to
`conduct two double-blind, placebo-controlled, multisite Phase
`3 clinical trials to evaluate the safety and efficacy of T121 for
`the treatment of pain associated with complex regional pain
`syndrome, or CRPS, and any remaining proceeds for research
`and development using our Enhance platform to create a
`pipeline of novel, patentable oral product candidates, patent-
`related expenses, working capital and other general corporate
`purposes. See “Use of Proceeds” for additional information.
`
`See “Risk Factors” and the other information included in this
`prospectus for a discussion of factors you should carefully
`consider before deciding to invest in our common stock.
`
`Proposed NASDAQ Global Market symbol
`
`“THAR”
`
`7
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`Page 13
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`

`

`Table of Contents
`
`The number of shares of our common stock to be outstanding after this offering is based on
` shares of our common stock outstanding as of June 30, 2016 and excludes:
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`348,075 shares of common stock issuable upon the exercise of stock options outstanding as of June
`30, 2016 at a weighted-average exercise price of $7.18 per share;
`
` shares of common stock reserved for future issuance under our 2016 Stock Option and
`Incentive Plan, or the 2016 Plan; and
`
` shares of common stock reserved for the future issuance under our 2016 Employee Stock
`Purchase Plan.
`
`Unless otherwise indicated, all information in this prospectus reflects or assumes the following:
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`a -for- reverse stock split of our common stock, which will become effective prior to the
`effectiveness of the registration statement of which this prospectus forms a part;
`
`the amendment and restatement of our certificate of incorporation and bylaws, which will occur upon
`the consummation of this offering;
`
`the conversion of all of our outstanding shares of our preferred stock into 961,180 shares of common
`stock, which will occur automatically immediately prior to the closing of this offering;
`
`our receipt of $185,000 in aggreg