Eledon Pharmaceuticals (ELDN) 10-Q 3 May 17 2017 Q1 Quarterly report Financial data

Document and Entity Information

Document and Entity Information - shares	3 Months Ended
	Mar. 31, 2017	Apr. 30, 2017
Document And Entity Information [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Period End Date	Mar. 31, 2017
Document Fiscal Year Focus	2,017
Document Fiscal Period Focus	Q1
Trading Symbol	TKAI
Entity Registrant Name	TOKAI PHARMACEUTICALS INC
Entity Central Index Key	1,404,281
Current Fiscal Year End Date	--12-31
Entity Filer Category	Accelerated Filer
Entity Common Stock, Shares Outstanding		22,641,651

Balance Sheets

Balance Sheets - USD ($) $ in Thousands	Mar. 31, 2017	Dec. 31, 2016
Current assets:
Cash and cash equivalents	$ 24,400	$ 23,223
Marketable securities		4,175
Restricted cash		150
Prepaid expenses and other current assets	1,231	1,995
Total current assets	25,631	29,543
Property and equipment, net	80	98
Restricted cash	120	120
Total assets	25,831	29,761
Current liabilities:
Accounts payable	276	430
Accrued expenses	2,143	2,389
Total current liabilities	2,419	2,819
Long-term liabilities	48	84
Total liabilities	2,467	2,903
Commitments and contingencies (Note 6)
Stockholders' equity:
Preferred stock, $0.001 par value; 5,000,000 shares authorized; no shares issued or outstanding
Common stock, $0.001 par value; 200,000,000 shares authorized; 22,641,651 shares issued and outstanding at March 31, 2017 and December 31, 2016	23	23
Additional paid-in capital	196,604	196,233
Accumulated other comprehensive loss		(1)
Accumulated deficit	(173,263)	(169,397)
Total stockholders' equity	23,364	26,858
Total liabilities and stockholders' equity	$ 25,831	$ 29,761

Balance Sheets (Parenthetical)

Balance Sheets (Parenthetical) - $ / shares	Mar. 31, 2017	Dec. 31, 2016
Statement of Financial Position [Abstract]
Preferred stock, par value	$ 0.001	$ 0.001
Preferred stock, shares authorized	5,000,000	5,000,000
Preferred stock, shares issued	0	0
Preferred stock, shares outstanding	0	0
Common stock, par value	$ 0.001	$ 0.001
Common stock, shares authorized	200,000,000	200,000,000
Common stock, shares issued	22,641,651	22,641,651
Common stock, shares outstanding	22,641,651	22,641,651

Statements of Operations and Co

Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2017	Mar. 31, 2016
Income Statement [Abstract]
Revenue	$ 0	$ 0
Operating expenses:
Research and development	306	7,931
General and administrative	3,586	3,549
Total operating expenses	3,892	11,480
Loss from operations	(3,892)	(11,480)
Interest income and other income, net	26	54
Net loss	$ (3,866)	$ (11,426)
Net loss per share, basic and diluted	$ (0.17)	$ (0.51)
Weighted average common shares outstanding, basic and diluted	22,641,651	22,625,009
Comprehensive loss:
Net loss	$ (3,866)	$ (11,426)
Other comprehensive income:
Unrealized gains on marketable securities	1	50
Total other comprehensive income	1	50
Total comprehensive loss	$ (3,865)	$ (11,376)

Statements of Cash Flows

Statements of Cash Flows - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2017	Mar. 31, 2016
Cash flows from operating activities:
Net loss	$ (3,866)	$ (11,426)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense	371	1,022
Depreciation expense	17	53
Impairment of property and equipment	1
Amortization of premium on marketable securities	1	37
Changes in operating assets and liabilities:
Prepaid expenses and other current assets	764	521
Accounts payable	(154)	678
Accrued expenses	(246)	(663)
Other long-term liabilities	(36)	38
Net cash used in operating activities	(3,148)	(9,740)
Cash flows from investing activities:
Proceeds from maturities of marketable securities	4,175
Purchases of property and equipment		(17)
Change in restricted cash	150
Net cash provided by (used in) investing activities	4,325	(17)
Cash flows from financing activities:
Proceeds from exercise of common stock options		37
Net cash provided by financing activities		37
Net increase (decrease) in cash and cash equivalents	1,177	(9,720)
Cash and cash equivalents at beginning of period	23,223	24,023
Cash and cash equivalents at end of period	$ 24,400	$ 14,303

Nature of the Business and Basi

Nature of the Business and Basis of Presentation	3 Months Ended
	Mar. 31, 2017
Accounting Policies [Abstract]
Nature of the Business and Basis of Presentation	1. Nature of the Business and Basis of Presentation Tokai Pharmaceuticals, Inc. (the “Company”) was incorporated on March 26, 2004 under the laws of the State of Delaware. The Company is a biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of prostate cancer and other hormonally-driven diseases. The Company has focused substantially all of its research and development efforts on the development of galeterone, an oral small molecule, including clinical trials of galeterone for the treatment of patients with metastatic castration-resistant prostate cancer (“mCRPC”). The Company also has a drug discovery program, known as ARDA (androgen receptor degradation agents), under which it identified novel compounds for patients with androgen receptor signaling diseases, including prostate cancer. In July 2016, the Company announced its plan to discontinue ARMOR3-SV, ® treatment-naïve AR-V7 ARMOR3-SV AR-V7 ARMOR3-SV ARMOR3-SV In addition, in August 2016, the Company determined to discontinue enrollment in its Phase 2 ARMOR2 expansion clinical trial of galeterone in mCRPC patients with acquired resistance to Xtandi and not to proceed with its planned study of galeterone in mCRPC patients who rapidly progress on either enzalutamide or Zytiga ® In September 2016, the Company announced that the board of directors had initiated a review of strategic alternatives that could result in changes to its business strategy and future operations. The objective of this review, which was conducted in parallel with the review of development options for galeterone and the ARDA program, was to maximize shareholder value. On December 21, 2016, the Company entered into a Share Purchase Agreement (the “Share Purchase Agreement”) with Otic Pharma, Ltd., a private limited company organized under the laws of the State of Israel (“Otic”) and the shareholders of Otic (the “Selling Shareholders”) pursuant to which, among other things, each Selling Shareholder agreed to sell to the Company, and the Company agreed to purchase from each Selling Shareholder, all of the ordinary and preferred shares of Otic (the “Otic Shares”) owned by such Selling Shareholder (the “Otic Transaction”). See “Note 9. Share Purchase Agreement” for further information regarding the Otic Transaction. The Company amended and restated the Share Purchase Agreement on March 2, 2017 to update the allocation of shares of the Company’s common stock among the Selling Shareholders and to extend to May 31, 2017, the date after which the Company or Otic may terminate the Share Purchase Agreement. The Company is subject to risks common to companies in the biotechnology industry including, but not limited to, new technological innovations, protection of proprietary technology, dependence on key personnel, compliance with government regulations and the need to obtain additional financing. Galeterone and any product candidates that the Company may seek to develop in the future under the ARDA program or otherwise, will require significant additional research and development efforts, including extensive preclinical and clinical testing, formulation development and manufacturing, and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel infrastructure, and extensive compliance capabilities. There can be no assurance that the Company’s research and development activities will be successfully completed, that adequate protection for the Company’s intellectual property will be obtained or maintained, that any products developed will obtain necessary regulatory approval or that any approved products will be commercially viable. Even if the Company’s drug development efforts are successful, it is uncertain when, if ever, the Company will generate significant revenue from product sales. The Company operates in an environment of rapid change in technology and substantial competition from pharmaceutical and biotechnology companies. In addition, the Company is dependent upon the services of its employees, consultants and contracted service providers. The Company’s common stock is currently listed for quotation on the NASDAQ Global Market. On March 8, 2017, the Company received a deficiency letter from the Listing Qualifications Department of the NASDAQ Stock Market notifying the Company that, for the last 30 consecutive business days prior to the date of the letter, the bid price for its common stock had closed below the minimum $1.00 per share requirement for continued inclusion on the NASDAQ Global Market. The Company has been provided an initial period of 180 calendar days, or until September 4, 2017, to regain compliance with the listing requirements. If, at any time before September 4, 2017, the bid price for the Company’s common stock closes at $1.00 or more for a minimum of 10 consecutive business days it may be eligible to regain compliance with the minimum bid requirement. Under certain circumstances, NASDAQ could require that the minimum bid price exceed $1.00 for more than ten consecutive days before determining that the Company complies with NASDAQ’s continued listing standards. The Company is seeking approval of a reverse stock split at its upcoming Special Meeting of Stockholders to be held on May 9, 2017 in connection with the Otic Transaction. The Company expects that the reverse stock split, if approved, would help it regain compliance with the listing standards. If the Company’s common stock is delisted by NASDAQ, the common stock may be eligible to trade on the OTC Bulletin Board or another over-the-counter The Company’s financial statements have been prepared on the basis of continuity of operations, realization of assets and satisfaction of liabilities in the ordinary course of business. The Company has incurred losses and negative cash flows from operations since inception. As of March 31, 2017, the Company had an accumulated deficit of $173,263 and had cash and cash equivalents of $24,400. In light of the discontinuation of the ARMOR3-SV The balance sheet at December 31, 2016 was derived from audited financial statements, but does not include all disclosures required by U.S. generally accepted accounting principles (“GAAP”). The accompanying unaudited financial statements as of March 31, 2017 and for the three months ended March 31, 2017 and 2016 have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. The Company believes, however, that the disclosures are adequate to make the information presented not misleading. These financial statements should be read in conjunction with the Company’s audited financial statements and the notes thereto for the year ended December 31, 2016 included in the Company’s Annual Report on Form 10-K

Summary of Significant Accounti

Summary of Significant Accounting Policies	3 Months Ended
	Mar. 31, 2017
Accounting Policies [Abstract]
Summary of Significant Accounting Policies	2. Summary of Significant Accounting Policies Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates, assumptions and judgments that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of expenses during the reporting periods. Significant estimates, assumptions and judgments reflected in these financial statements include, but are not limited to, the accrual of research and development expenses and the valuation of stock-based awards. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Actual results could differ from the Company’s estimates. Marketable Securities The Company’s marketable securities are classified as available-for-sale At March 31, 2017, there were no marketable securities. At December 31, 2016 marketable securities by security type consisted of: Gross Gross Estimated Amortized Unrealized Unrealized Fair Cost Gains Losses Value Certificates of Deposit (due within one year) $ 1,175 $ — $ — $ 1,175 United States Treasury Notes (due within one year) 3,001 — (1 ) 3,000 Total $ 4,176 $ — $ (1 ) $ 4,175 Fair Value Measurements Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: • Level 1—Quoted prices in active markets for identical assets or liabilities. • Level 2—Observable inputs (other than Level 1 quoted prices) such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. • Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. The following tables present the Company’s fair value hierarchy for its cash equivalents and marketable securities, which are measured at fair value on a recurring basis at March 31, 2017 and December 31, 2016: Fair Value Measurements at March 31, 2017 Using Level 1 Level 2 Level 3 Total Cash equivalents: Money Market Instruments $ — $ 22,943 $ — $ 22,943 Total $ — $ 22,943 $ — $ 22,943 Fair Value Measurements at December 31, 2016 Using Level 1 Level 2 Level 3 Total Cash equivalents: Money Market Instruments $ — $ 17,748 $ — $ 17,748 Marketable securities: Certificates of Deposit — 1,175 — 1,175 United States Treasury Notes — 3,000 — 3,000 Total $ — $ 21,923 $ — $ 21,923 The carrying values of accounts payable and accrued expenses approximate their fair value due to the short-term nature of these liabilities. Net Loss Per Share Basic net loss per share is computed by dividing the net loss by the weighted average number of common shares outstanding for the period. Because the inclusion of common share equivalents in the calculation would be anti-dilutive for all periods presented, diluted net loss per share is the same as basic net loss per share. The following common share equivalents outstanding as of March 31, 2017 and 2016 were excluded from the computation of diluted net loss per share for the three months ended March 31, 2017 and 2016 because they had an anti-dilutive impact: March 31, 2017 2016 Stock options to purchase common stock 1,855,741 3,035,315 Unvested restricted common stock units — 34,128 1,855,741 3,069,443 Recently Issued or Adopted Accounting Pronouncements In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-02, Leases 2016-02”), 2016-02 In November 2016, the FASB issued ASU No. 2016-18, Statement of Cash Flows: Restricted Cash 2016-18”). 2016-18 2016-18 Effective January 1, 2017, the Company adopted ASU No. 2016-09, Compensation – Stock Compensation 2016-09”) 2016-09 paid-in-capital

Accrued Expenses

Accrued Expenses	3 Months Ended
	Mar. 31, 2017
Payables and Accruals [Abstract]
Accrued Expenses	3. Accrued Expenses Accrued expenses consisted of the following: March 31, December 31, 2017 2016 Accrued professional fees $ 1,105 $ 871 Accrued research and development expenses 623 907 Accrued payroll and related expenses 186 394 Accrued other 229 217 $ 2,143 $ 2,389

Income Taxes

Income Taxes	3 Months Ended
	Mar. 31, 2017
Income Tax Disclosure [Abstract]
Income Taxes	4. Income Taxes The Company did not provide for any income taxes in the three months ended March 31, 2017 or 2016. The Company had gross deferred tax assets of $65,643 at December 31, 2016, which increased by approximately $1,000 at March 31, 2017 due to the Company’s net operating loss. In addition, in connection with the adoption of ASU No. 2016-09 The Company has not recorded any amounts for unrecognized tax benefits as of March 31, 2017 or December 31, 2016. As of March 31, 2017 and December 31, 2016, the Company had no accrued interest or tax penalties recorded. The Company’s income tax return reporting periods since December 31, 2013 are open to income tax audit examination by the federal and state tax authorities. In addition, because the Company has net operating loss carryforwards, the Internal Revenue Service is permitted to audit earlier years and propose adjustments up to the amount of net operating losses generated in those years.

Stock-Based Compensation

Stock-Based Compensation	3 Months Ended
	Mar. 31, 2017
Disclosure of Compensation Related Costs, Share-based Payments [Abstract]
Stock-Based Compensation	5. Stock-Based Compensation The Company grants stock-based awards under its 2014 Stock Incentive Plan and is authorized to issue, but has not issued as of March 31, 2017, common stock under its 2014 Employee Stock Purchase Plan. The Company also has outstanding stock options under its 2007 Stock Incentive Plan, but is no longer granting awards under this plan. As of March 31, 2017, 3,967,421 shares of common stock were available for issuance under the 2014 Stock Incentive Plan. As of March 31, 2017, 451,416 shares of common stock were available for issuance to participating employees under the 2014 Employee Stock Purchase Plan. The Company recorded stock-based compensation expense related to stock options and restricted common stock units in the following expense categories of its statements of operations: Three Months Ended March 31 2017 2016 Research and development $ 24 $ 211 General and administrative 347 811 $ 371 $ 1,022

Commitments and Contingencies

Commitments and Contingencies	3 Months Ended
	Mar. 31, 2017
Commitments and Contingencies Disclosure [Abstract]
Commitments and Contingencies	6. Commitments and Contingencies Leases In February 2015, the Company entered into a sublease with a Massachusetts limited liability company (the “Sublandlord”) for 15,981 square feet of office space in Boston, Massachusetts. The sublease was subject and subordinate to a prime lease between the Sublandlord and the prime landlord. The term of the sublease commenced on April 1, 2015 and expired on December 31, 2016. In June 2015, the Company entered into a lease (the “New Lease”) for the existing space with the prime landlord (the “Landlord”), which effectively extends the term until July 31, 2018. Payment escalations specified in the lease agreements are accrued such that rent expense per square foot is recognized on a straight-line basis over the terms of occupancy. During the three months ended March 31 2017 and 2016, the Company recognized $175 and $174, respectively, of rental expense related to office space. As of March 31, 2017, future minimum lease payments under the noncancelable office lease are as follows: Remainder of 2017 $ 629 2018 489 $ 1,118 Restricted Cash and Letters of Credit The Company held a money market account as of March 31, 2017 and December 31, 2016 to collateralize a credit card account with its bank. As of March 31, 2017, the balance of the money market account was $50, which was classified as long-term restricted cash. As of December 31, 2016, the balance of the money market account was $200, of which $150 was classified as current restricted cash and $50 was classified as long-term restricted cash. The Company is required to maintain a letter of credit totaling $70 for the benefit of the Landlord of the New Lease. The Landlord can draw against the letter of credit in the event of default by the Company. The Company held $70 in a money market account to collateralize the letter of credit, which amount was also included in restricted cash on the balance sheet as of March 31, 2017 and December 31, 2016. Intellectual Property Licenses The Company has a master license agreement with the University of Maryland, Baltimore (“UMB”). Pursuant to the license agreement, UMB granted an exclusive, worldwide license, with the right to sublicense, under certain patents and patent applications to make, have made, use, sell, offer to sell and import certain anti-androgen steroids, including galeterone, for the prevention, diagnosis, treatment or control of any human or animal disease. In addition, UMB granted the Company a first option to receive an exclusive license to UMB’s rights in certain improvements to the licensed products. The Company has exercised its option and acquired exclusive rights to licensed improvements under four amendments to the license agreement. The Company is obligated to pay UMB an annual maintenance fee of $10 each year until the first commercial sale of a product developed using the licensed technology. The Company is also obligated to make milestone payments of an additional $50 for the filing of each additional investigational new drug application filed for a licensed product, aggregate milestone payments of up to $150 associated with the development of a licensed product for a particular non-prostate The Company must also pay UMB a low-single product-by-licensed country-by-country last-to-expire non-royalty In January 2015, the Company entered into an exclusive license agreement with The Johns Hopkins University (“Johns Hopkins”) pursuant to which Johns Hopkins granted the Company an exclusive, worldwide license under certain patents and patent applications, and a non-exclusive know-how, In consideration for the rights granted to the Company under the license agreement, the Company made an upfront payment to Johns Hopkins of $75 following the execution of the license agreement in 2015. The Company is obligated to pay Johns Hopkins an annual minimum royalty of up to $30 and to make milestone payments to Johns Hopkins upon the achievement of specified technical and commercial milestones. If all such milestones were achieved, the total milestone payments owed to Johns Hopkins would equal $700 in the aggregate. The Company expensed $50 related to the achievement of two of these milestones in 2015. The Company has not achieved any other milestones and, therefore, no additional liabilities for such milestone payments have been recorded in the Company’s financial statements. The Company must also pay Johns Hopkins single digit percentage royalties on aggregate worldwide net sales of licensed products (but not galeterone), including sales by sublicensees, on a licensed product-by-licensed country-by-country last-to-expire non-royalty Indemnification Agreements In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners, and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with each of its directors and executive officers, which provide, among other things, that the Company will indemnify such directors and executive officers to the fullest extent permitted by law for claims arising in his or her capacity as a director or officer. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited. To date, the Company has not incurred material costs as a result of the indemnification agreements described above. In addition, the Company maintains directors and officers insurance coverage. The Company is unable to predict if any claims under indemnification arrangements will have a material effect on its financial position, results of operations or cash flows and has not accrued any material liabilities related to such possible obligations in its financial statements as of March 31, 2017. Legal Proceedings On August 1, 2016, a purported stockholder of the Company filed a putative class action lawsuit in the U.S. District Court for the Southern District of New York against the Company, Jodie P. Morrison, and Lee H. Kalowski, entitled Doshi v. Tokai Pharmaceuticals, Inc., et al., No. 1:16-cv-06106 10b-5 On August 19, 2016, a purported stockholder of the Company filed a putative class action lawsuit in the Superior Court of the State of California, County of San Francisco, against the Company, Jodie P. Morrison, Lee H. Kalowski, Seth L. Harrison, Timothy J. Barberich, David A. Kessler, Joseph A. Yanchik, III, and the underwriters of the Company’s initial public offering (“IPO”), entitled Jackie888, Inc. v. Tokai Pharmaceuticals, Inc., et al., No. CGC-16-553796. On September 29, 2016, two purported stockholders of the Company filed a putative class action lawsuit in the U.S. District Court for the District of Massachusetts against the Company, Jodie Pope Morrison, Lee H. Kalowski, Seth L. Harrison, Timothy J. Barberich, David A. Kessler, Joseph A. Yanchik, III, and the underwriters of the Company’s IPO, entitled Garbowski, et al. v. Tokai Pharmaceuticals, Inc., et al., No. 1:16-cv-11963 10b-5. On December 5, 2016, a putative securities class action was filed in the Business Litigation Session of the Superior Court Department of the Suffolk County Trial Court, Massachusetts (“Massachusetts State Court”) against the Company, Jodie P. Morrison, Lee H. Kalowski, Seth L. Harrison, Timothy J. Barberich, David A. Kessler, Joseph A. Yanchik, III, and the underwriters of the Company’s IPO, entitled Wu v. Tokai Pharmaceuticals, Inc., et al., 16-3725 16-cv-12550, In connection with the Otic Transaction, two putative securities class actions have been filed in the U.S. District Court for the District of Massachusetts against the Company, Jodie P. Morrison, Seth L. Harrison, Stephen Buckley, Jr., Cheryl L. Cohen, David A. Kessler, and Joseph A. Yanchik, III. The two complaints are captioned as follows: Bushansky v. Tokai Pharmaceuticals, Inc., et al. 1:17-cv-10621-DPW Wilson v. Tokai Pharmaceuticals, Inc., et al. 1:17-cv-10645-DPW 14a-9, The Company believes it has valid defenses, and intends to engage in a vigorous defense of the litigation. However, the Company is unable to predict the ultimate outcome of these actions, and, therefore cannot estimate possible losses or ranges of losses, if any, or the materiality thereof. An unexpected unfavorable resolution of these matters in any reporting period may have a material adverse effect on the Company’s results of operations and cash flows for that period.

401(k) Plan

401(k) Plan	3 Months Ended
	Mar. 31, 2017
Postemployment Benefits [Abstract]
401(k) Plan	7. 401(k) Plan The Company has a 401(k) plan available for participating employees who meet certain eligibility requirements. Eligible employees may defer a portion of their salary as defined by the plan. Company contributions to the plan may be made at the discretion of the Board of Directors. Since January 1, 2017, the Company has made matching contributions for the plan year ending December 31, 2017 at a rate of 100% of each employee’s contribution up to a maximum matching contribution of 3% of the employee’s eligible plan compensation and at a rate of 50% of each employee’s contribution in excess of 3% up to a maximum of 5% of the employee’s eligible plan compensation. For the three months ended March 31, 2017 and 2016, the Company made matching contributions of $19 and $45, respectively.

Related Party Transaction

Related Party Transaction	3 Months Ended
	Mar. 31, 2017
Related Party Transactions [Abstract]
Related Party Transaction	8. Related Party Transaction In September 21, 2016, the Company entered into a consulting agreement with Apple Tree Life Sciences, Inc. (“Apple Tree”) under which Apple Tree agreed to provide consulting, advisory and related services to and for the Company from time to time. There is no fee for these services except for reimbursement of out of pocket expenses. Affiliates of Apple Tree beneficially own approximately 35% of the Company, and Dr. Seth Harrison, a member of the Company’s board of directors, is a principal of Apple Tree.

Share Purchase Agreement

Share Purchase Agreement	3 Months Ended
	Mar. 31, 2017
Accounting Policies [Abstract]
Share Purchase Agreement	9. Share Purchase Agreement On December 21, 2016, the Company entered into the Share Purchase Agreement with Otic and the Selling Shareholders pursuant to which, among other things, each Selling Shareholder agreed to sell to the Company, and the Company agreed to purchase from each Selling Shareholder, all of the Otic Shares owned by such Selling Shareholder. Immediately following the closing of the Otic Transaction, the Selling Shareholders are expected to own approximately 60% of the Company’s outstanding common stock (62% if all of Otic’s outstanding options and warrants are exercised prior to closing). Consummation of the Otic Transaction is subject to certain closing conditions, including, among other things, approval by the Company’s stockholders at its upcoming Special Meeting of Stockholders to be held on May 9, 2017. The Share Purchase Agreement contains certain termination rights for both the Company and Otic, and further provides that, upon termination of the Share Purchase Agreement under specified circumstances, the Company may be required to pay Otic a termination fee of $1,000, or Otic may be required to pay the Company a termination fee of $1,500. Upon the delivery of a fairness opinion of the Otic Transaction, the Company owes its strategic advisor $500. An additional $500 is due to its strategic advisor upon consummation of the transaction with Otic. The Company has expensed $500 during the three months ended March 31, 2017 related to the delivery of the fairness opinion. The Company determined the $500 due upon delivery of the fairness opinion should have been accrued as of December 31, 2016. The impact of this error was not material to the financial statements for the year ended December 31, 2016. The subsequent correction was made in the financial statements for the three months ended March 31 2017 and was not material. There can be no assurances that the Otic Transaction will be consummated. The Company amended and restated the Share Purchase Agreement on March 2, 2017 to update the allocation of shares of the Company’s common stock among the Selling Shareholders, to update the manner in which Otic options and warrants are converted and to extend to May 31, 2017, the date after which the Company or Otic may terminate the Share Purchase Agreement. In addition, the Company has entered into a commitment letter with Otic and certain purchasers set forth therein under which the purchasers have agreed to invest up to $7,000 of new capital in Otic and/or Tokai prior to or upon the closing of the Otic Transaction. Pursuant to this commitment letter, on January 31, 2017, the Company entered into a stock purchase agreement with the parties to the commitment letter under which such parties agreed to purchase 3,603,601 shares of the Company’s common stock at a price of $1.11 per share. The purchase and sale of the Company’s common stock pursuant to this stock purchase agreement will occur at the time of the closing of the Otic Transaction. The remaining $3,000 will be invested in Otic prior to the closing of the Otic Transaction through the exercise of outstanding warrants.

Summary of Significant Accoun15

Summary of Significant Accounting Policies (Policies)	3 Months Ended
	Mar. 31, 2017
Accounting Policies [Abstract]
Use of Estimates	Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates, assumptions and judgments that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of expenses during the reporting periods. Significant estimates, assumptions and judgments reflected in these financial statements include, but are not limited to, the accrual of research and development expenses and the valuation of stock-based awards. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Actual results could differ from the Company’s estimates.
Marketable Securities	Marketable Securities The Company’s marketable securities are classified as available-for-sale At March 31, 2017, there were no marketable securities. At December 31, 2016 marketable securities by security type consisted of: Gross Gross Estimated Amortized Unrealized Unrealized Fair Cost Gains Losses Value Certificates of Deposit (due within one year) $ 1,175 $ — $ — $ 1,175 United States Treasury Notes (due within one year) 3,001 — (1 ) 3,000 Total $ 4,176 $ — $ (1 ) $ 4,175
Fair Value Measurements	Fair Value Measurements Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: • Level 1—Quoted prices in active markets for identical assets or liabilities. • Level 2—Observable inputs (other than Level 1 quoted prices) such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. • Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. The following tables present the Company’s fair value hierarchy for its cash equivalents and marketable securities, which are measured at fair value on a recurring basis at March 31, 2017 and December 31, 2016: Fair Value Measurements at March 31, 2017 Using Level 1 Level 2 Level 3 Total Cash equivalents: Money Market Instruments $ — $ 22,943 $ — $ 22,943 Total $ — $ 22,943 $ — $ 22,943 Fair Value Measurements at December 31, 2016 Using Level 1 Level 2 Level 3 Total Cash equivalents: Money Market Instruments $ — $ 17,748 $ — $ 17,748 Marketable securities: Certificates of Deposit — 1,175 — 1,175 United States Treasury Notes — 3,000 — 3,000 Total $ — $ 21,923 $ — $ 21,923 The carrying values of accounts payable and accrued expenses approximate their fair value due to the short-term nature of these liabilities.
Net Loss Per Share	Net Loss Per Share Basic net loss per share is computed by dividing the net loss by the weighted average number of common shares outstanding for the period. Because the inclusion of common share equivalents in the calculation would be anti-dilutive for all periods presented, diluted net loss per share is the same as basic net loss per share. The following common share equivalents outstanding as of March 31, 2017 and 2016 were excluded from the computation of diluted net loss per share for the three months ended March 31, 2017 and 2016 because they had an anti-dilutive impact: March 31, 2017 2016 Stock options to purchase common stock 1,855,741 3,035,315 Unvested restricted common stock units — 34,128 1,855,741 3,069,443
Recently Issued or Adopted Accounting Pronouncements	Recently Issued or Adopted Accounting Pronouncements In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-02, Leases 2016-02”), 2016-02 In November 2016, the FASB issued ASU No. 2016-18, Statement of Cash Flows: Restricted Cash 2016-18”). 2016-18 2016-18 Effective January 1, 2017, the Company adopted ASU No. 2016-09, Compensation – Stock Compensation 2016-09”) 2016-09 paid-in-capital

Summary of Significant Accoun16

Summary of Significant Accounting Policies (Tables)	3 Months Ended
	Mar. 31, 2017
Accounting Policies [Abstract]
Schedule of Marketable Securities by Security Type	At December 31, 2016 marketable securities by security type consisted of: Gross Gross Estimated Amortized Unrealized Unrealized Fair Cost Gains Losses Value Certificates of Deposit (due within one year) $ 1,175 $ — $ — $ 1,175 United States Treasury Notes (due within one year) 3,001 — (1 ) 3,000 Total $ 4,176 $ — $ (1 ) $ 4,175
Schedule of Fair Value Measured on Recurring Basis	The following tables present the Company’s fair value hierarchy for its cash equivalents and marketable securities, which are measured at fair value on a recurring basis at March 31, 2017 and December 31, 2016: Fair Value Measurements at March 31, 2017 Using Level 1 Level 2 Level 3 Total Cash equivalents: Money Market Instruments $ — $ 22,943 $ — $ 22,943 Total $ — $ 22,943 $ — $ 22,943 Fair Value Measurements at December 31, 2016 Using Level 1 Level 2 Level 3 Total Cash equivalents: Money Market Instruments $ — $ 17,748 $ — $ 17,748 Marketable securities: Certificates of Deposit — 1,175 — 1,175 United States Treasury Notes — 3,000 — 3,000 Total $ — $ 21,923 $ — $ 21,923
Schedule of Common Stock Equivalents, Excluded from Computation of Diluted Net Loss per Share	The following common share equivalents outstanding as of March 31, 2017 and 2016 were excluded from the computation of diluted net loss per share for the three months ended March 31, 2017 and 2016 because they had an anti-dilutive impact: March 31, 2017 2016 Stock options to purchase common stock 1,855,741 3,035,315 Unvested restricted common stock units — 34,128 1,855,741 3,069,443

Accrued Expenses (Tables)

Accrued Expenses (Tables)	3 Months Ended
	Mar. 31, 2017
Payables and Accruals [Abstract]
Schedule of Accrued Expenses	Accrued expenses consisted of the following: March 31, December 31, 2017 2016 Accrued professional fees $ 1,105 $ 871 Accrued research and development expenses 623 907 Accrued payroll and related expenses 186 394 Accrued other 229 217 $ 2,143 $ 2,389

Stock-Based Compensation (Table

Stock-Based Compensation (Tables)	3 Months Ended
	Mar. 31, 2017
Disclosure of Compensation Related Costs, Share-based Payments [Abstract]
Schedule of Stock-Based Compensation Expense Related to Stock Options and Restricted Common Stock Units	The Company recorded stock-based compensation expense related to stock options and restricted common stock units in the following expense categories of its statements of operations: Three Months Ended March 31 2017 2016 Research and development $ 24 $ 211 General and administrative 347 811 $ 371 $ 1,022

Commitments and Contingencies (

Commitments and Contingencies (Tables)	3 Months Ended
	Mar. 31, 2017
Commitments and Contingencies Disclosure [Abstract]
Schedule of Future Minimum Lease Payments Under Noncancelable Office Lease	As of March 31, 2017, future minimum lease payments under the noncancelable office lease are as follows: Remainder of 2017 $ 629 2018 489 $ 1,118

Nature of the Business and Ba20

Nature of the Business and Basis of Presentation - Additional Information (Detail) $ / shares in Units, $ in Thousands	Mar. 31, 2017USD ($)Patient	Mar. 08, 2017$ / shares	Mar. 31, 2017USD ($)	Sep. 30, 2016	Dec. 31, 2016USD ($)	Mar. 31, 2016USD ($)	Dec. 31, 2015USD ($)
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Percentage of reduction in workforce				60.00%
Number of patients | Patient	10
NASDAQ listing requirement			On March 8, 2017, the Company received a deficiency letter from the Listing Qualifications Department of the NASDAQ Stock Market notifying the Company that, for the last 30 consecutive business days prior to the date of the letter, the bid price for its common stock had closed below the minimum $1.00 per share requirement for continued inclusion on the NASDAQ Global Market. The Company has been provided an initial period of 180 calendar days, or until September 4, 2017, to regain compliance with the listing requirements. If, at any time before September 4, 2017, the bid price for the Company’s common stock closes at $1.00 or more for a minimum of 10 consecutive business days it may be eligible to regain compliance with the minimum bid requirement. Under certain circumstances, NASDAQ could require that the minimum bid price exceed $1.00 for more than ten consecutive days before determining that the Company complies with NASDAQ’s continued listing standards.
Minimum stock price for continued listing | $ / shares		$ 1
Number of consecutive trading days for continued listing		10 days
Accumulated deficit	$ (173,263)		$ (173,263)		$ (169,397)
Cash and cash equivalents	$ 24,400		$ 24,400		$ 23,223	$ 14,303	$ 24,023

Summary of Significant Accoun21

Summary of Significant Accounting Policies - Additional Information (Detail)	3 Months Ended
	Mar. 31, 2017USD ($)
Summary Of Significant Accounting Policies [Line Items]
Marketable securities	$ 0
Increase in gross deferred tax assets	1,000,000
ASU 2016-09 [Member]
Summary Of Significant Accounting Policies [Line Items]
Increase in gross deferred tax assets	1,400,000
Increase in valuation allowance	$ 1,400,000

Summary of Significant Accoun22

Summary of Significant Accounting Policies - Schedule of Marketable Securities by Security Type (Detail) $ in Thousands	Dec. 31, 2016USD ($)
Schedule of Available-for-sale Securities [Line Items]
Amortized Cost	$ 4,176
Gross Unrealized Gains	0
Gross Unrealized Losses	(1)
Estimated Fair Value	4,175
Certificates of Deposit Due within One Year [Member]
Schedule of Available-for-sale Securities [Line Items]
Amortized Cost	1,175
Gross Unrealized Gains	0
Estimated Fair Value	1,175
United States Treasury Notes Due Within One Year [Member]
Schedule of Available-for-sale Securities [Line Items]
Amortized Cost	3,001
Gross Unrealized Gains	0
Gross Unrealized Losses	(1)
Estimated Fair Value	$ 3,000

Summary of Significant Accoun23

Summary of Significant Accounting Policies - Schedule of Fair Value Measured on Recurring Basis (Detail) - USD ($) $ in Thousands	Mar. 31, 2017	Dec. 31, 2016
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Fair value measurements, cash equivalents and marketable securities	$ 22,943	$ 21,923
Money Market Instruments [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Fair value measurements, cash equivalents and marketable securities	22,943	17,748
Certificates of Deposit [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Fair value measurements, cash equivalents and marketable securities		1,175
United States Treasury Notes [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Fair value measurements, cash equivalents and marketable securities		3,000
Level 2 [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Fair value measurements, cash equivalents and marketable securities	22,943	21,923
Level 2 [Member] | Money Market Instruments [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Fair value measurements, cash equivalents and marketable securities	$ 22,943	17,748
Level 2 [Member] | Certificates of Deposit [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Fair value measurements, cash equivalents and marketable securities		1,175
Level 2 [Member] | United States Treasury Notes [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Fair value measurements, cash equivalents and marketable securities		$ 3,000

Summary of Significant Accoun24

Summary of Significant Accounting Policies - Schedule of Common Stock Equivalents, Excluded from Computation of Diluted Net Loss per Share (Detail) - shares	3 Months Ended
	Mar. 31, 2017	Mar. 31, 2016
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total options, restricted stock units exercisable or convertible into common stock	1,855,741	3,069,443
Stock Options to Purchase Common Stock [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total options, restricted stock units exercisable or convertible into common stock	1,855,741	3,035,315
Unvested Restricted Common Stock Units [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total options, restricted stock units exercisable or convertible into common stock		34,128

Accrued Expenses - Schedule of

Accrued Expenses - Schedule of Accrued Expenses (Detail) - USD ($) $ in Thousands	Mar. 31, 2017	Dec. 31, 2016
Payables and Accruals [Abstract]
Accrued professional fees	$ 1,105	$ 871
Accrued research and development expenses	623	907
Accrued payroll and related expenses	186	394
Accrued other	229	217
Total	$ 2,143	$ 2,389

Income Taxes - Additional Infor

Income Taxes - Additional Information (Detail) - USD ($)	3 Months Ended
	Mar. 31, 2017	Mar. 31, 2016	Dec. 31, 2016
Tax Credit Carryforward [Line Items]
Income tax benefits / expense	$ 0	$ 0
Deferred tax assets, gross			$ 65,643,000
Increase in gross deferred tax assets	1,000,000
Unrecognized tax benefits	0		0
Accrued interest or tax penalties	$ 0		$ 0
Income tax earliest examination year	2,013
ASU 2016-09 [Member]
Tax Credit Carryforward [Line Items]
Increase in gross deferred tax assets	$ 1,400,000
Increase in valuation allowance	$ 1,400,000

Stock-Based Compensation - Addi

Stock-Based Compensation - Additional Information (Detail)	Mar. 31, 2017shares
2014 Stock Incentive Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Common stock, shares available for issuance	3,967,421
2014 Employee Stock Purchase Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Common stock, shares available for issuance	451,416

Stock-Based Compensation - Sche

Stock-Based Compensation - Schedule of Stock-Based Compensation Expense Related to Stock Options and Restricted Common Stock Units (Detail) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2017	Mar. 31, 2016
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Stock-based compensation expense	$ 371	$ 1,022
Research and Development [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Stock-based compensation expense	24	211
General and Administrative [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Stock-based compensation expense	$ 347	$ 811

Commitments and Contingencies29

Commitments and Contingencies (Leases) - Additional Information (Detail) $ in Thousands	1 Months Ended		3 Months Ended
	Jun. 30, 2015	Feb. 28, 2015ft²	Mar. 31, 2017USD ($)	Mar. 31, 2016USD ($)
Other Commitments [Line Items]
Rental expense | $			$ 175	$ 174
Sublease [Member]
Other Commitments [Line Items]
Area of office space | ft²		15,981
Leases expiration date			Dec. 31, 2016
New Lease [Member]
Other Commitments [Line Items]
Leases expiration date	Jul. 31, 2018

Commitments and Contingencies -

Commitments and Contingencies - Schedule of Future Minimum Lease Payments Under Noncancelable Office Lease (Detail) $ in Thousands	Mar. 31, 2017USD ($)
Commitments and Contingencies Disclosure [Abstract]
Remainder of 2017	$ 629
2,018	489
Total	$ 1,118

Commitments and Contingencies31

Commitments and Contingencies (Restricted Cash and Letters of Credit) - Additional Information (Detail) - USD ($) $ in Thousands	Mar. 31, 2017	Dec. 31, 2016
Other Commitments [Line Items]
Restricted cash	$ 120	$ 120
Restricted cash, current		150
Money Market Instruments [Member]
Other Commitments [Line Items]
Restricted cash	50	50
Restricted cash, current		150
Restricted cash, current and non-current		200
Money Market Instruments [Member] | Letter of Credit [Member]
Other Commitments [Line Items]
Restricted cash	$ 70	$ 70

Commitments and Contingencies32

Commitments and Contingencies (Intellectual Property Licenses) - Additional Information (Detail)	1 Months Ended	3 Months Ended		12 Months Ended
	Jan. 31, 2015	Mar. 31, 2017USD ($)AmendmentsMilestone	Mar. 31, 2016Milestone	Dec. 31, 2015USD ($)
Other Commitments [Line Items]
Number of milestones achieved | Milestone		0	0
License Agreement [Member] | Johns Hopkins [Member]
Other Commitments [Line Items]
Percentage of non-royalty sub license income	20.00%
Upfront payment				$ 75,000
Potential milestone payments under license agreement				700,000
Milestone payments expensed during period				50,000
Additional liabilities for milestone payments				0
License Agreement [Member] | Johns Hopkins [Member] | Minimum [Member]
Other Commitments [Line Items]
Annual royalty				$ 30,000
Master License Agreement [Member] | UMB [Member]
Other Commitments [Line Items]
Number of amendments | Amendments		4
Annual maintenance fee		$ 10,000
Percentage of non-royalty sub license income		10.00%
Master License Agreement [Member] | UMB [Member] | Minimum [Member]
Other Commitments [Line Items]
Annual royalty		$ 50,000
IND [Member] | Master License Agreement [Member] | UMB [Member] | Upon Filing IND Application For Licensed Product [Member]
Other Commitments [Line Items]
Milestone payment		50,000
IND [Member] | Master License Agreement [Member] | UMB [Member] | Upon FDA Approval [Member]
Other Commitments [Line Items]
Milestone payment		100,000
Investigational Drug Application Non Prostate Disease [Member] | Master License Agreement [Member] | UMB [Member] | Maximum [Member]
Other Commitments [Line Items]
Aggregate milestone payments associated with development of licensed product		$ 150,000

401(k) Plan - Additional Inform

401(k) Plan - Additional Information (Detail) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2017	Mar. 31, 2016
Defined Contribution Plan Disclosure [Line Items]
Company contributions to 401 (k) plan	$ 19	$ 45
100% Matching Employer Contribution [Member] | Maximum [Member]
Defined Contribution Plan Disclosure [Line Items]
Employee's contribution	3.00%
Employer's contribution	100.00%
50% Matching Employer Contribution [Member] | Maximum [Member]
Defined Contribution Plan Disclosure [Line Items]
Employee's contribution	5.00%
Employer's contribution	50.00%
50% Matching Employer Contribution [Member] | Minimum [Member]
Defined Contribution Plan Disclosure [Line Items]
Employee's contribution	3.00%

Related Party Transactions - Ad

Related Party Transactions - Additional Information (Detail)	Sep. 21, 2016
Apple Tree Life Sciences, Inc. [Member] | Consulting Agreement [Member]
Related Party Transaction [Line Items]
Beneficial ownership percentage	35.00%

Share Purchase Agreement - Addi

Share Purchase Agreement - Additional Information (Detail) - USD ($)	Dec. 21, 2016	Jan. 31, 2017	Mar. 31, 2017	Dec. 31, 2016
Share Purchase Agreement [Line Items]
Strategic advisor fees payable	$ 500,000
Termination fee payable under share purchase agreement	$ 1,000,000
Strategic advisor fees			$ 500,000
Otic Pharma, Ltd. [Member]
Share Purchase Agreement [Line Items]
Percentage of ownership if Options and warrants are exercised before closing	62.00%
Percentage of ownership	60.00%
Strategic advisor fees payable	$ 500,000			$ 500,000
Termination fee receivable under share purchase agreement	$ 1,500,000
Number of shares Issued under Stock purchase agreement		3,603,601
Price of shares Issued under Stock purchase agreement		$ 1.11
Investment through exercise of warrants		3,000,000
Otic Pharma, Ltd. [Member] | Maximum [Member]
Share Purchase Agreement [Line Items]
Investment		$ 7,000,000