delisting.
To regain compliance, the minimum bid price of our common stock would need to reach at least $1.00 for 10 consecutive business days by August 22, 2016, and the minimum publicly held market value of the common stock would need to reach at least $15 million for 10 consecutive business days by August 22, 2016. All of these events are outside of our control at this time.
The delisting of our common stock from The Nasdaq Global Market would be considered a fundamental change under the indenture for our 8% convertible senior notes due June 15, 2019 (the “8% Notes”), and we could be required by the noteholders to purchase for cash all of the outstanding 8% Notes at a purchase price equal to 100% of the principal amount of the 8% Notes ($43.75 million of which are outstanding as of June 30, 2016) plus accrued and unpaid interest. We do not currently have sufficient funds on hand to satisfy the put obligations for the 8% Notes if all holders exercise their put right, and there can be no assurance that we will be able to obtain sufficient funds to meet our obligations with respect to the 8% Notes in the event that delisting occurs and the holders exercise their put right.
Delisting from The Nasdaq Global Market could also significantly affect the ability of investors to trade our common stock and negatively affect the value and liquidity of the common stock. Moreover, delisting could adversely affect our ability to raise additional financing through the public or private sale of securities, which may result in adverse effects on our operations and ability to continue as a going concern in the future.
We may also face other adverse consequences if our common stock is delisted including, among others, limited availability of market quotations for our common stock and limited ability to issue additional securities pursuant to our short-form registration statement on Form S-3, which may require us to rely on private sales of securities, thereby increasing dilution of existing holders of our common stock and/or resulting in greater expenses and delay if we determine it becomes necessary to conduct a public offering of securities by means of a long-form registration statement on Form S-1. In addition, if our common stock is delisted, the common stock may be deemed to be a “penny stock,” which (subject to limited exceptions) will require brokers dealing in the common stock to adhere to more stringent rules, including the requirement that broker-dealers must make a special written determination that the penny stock is a suitable investment for the purchaser, other than established customers of the broker-dealer and accredited investors, which
may restrict the ability of brokers or dealers to sell our common stock and may adversely affect the ability of our stockholders to sell their shares.
Should we regain compliance with the Nasdaq listing requirements, or otherwise satisfy our obligations with our noteholders, we believe our existing cash and investments will be sufficient to fund our current operating and investing activities through December 31, 2016. In order for our existing cash and investments to fund operating and investing activities through December 31, 2016, we have limited our planned business activities to the completion of the Phase 2 clinical trial of SHAPE and the winding down of the Phase 2 clinical trial in birinapant in MDS, and we effectuated a reduction in force in January 2016, which reduced our headcount to 9 employees in April 2016. Our headcount has since been reduced to 8 employees.
We have retained Houlihan Lokey Capital, Inc. as our financial advisor, to provide financial advisory, restructuring and investment-banking services in connection with analyzing and considering a wide range of transactional and strategic alternatives. We are currently negotiating the potential sale of one or both of our primary molecules, birinapant and Shape, to a third-party purchaser. We are also currently in active discussions with the noteholders of our 8% Notes regarding the possible early conversion of our 8% Notes into equity. We can give no assurance that either of these transactions will occur.
2. Summary of Significant Accounting Policies
Basis of Presentation
The consolidated financial statements are prepared in conformity with accounting principles generally accepted in the United States, or GAAP, for interim financial information. Certain information and footnotes normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to the rules and regulations of the Securities and Exchange Commission, or the SEC.
Unaudited Interim Financial Information
The accompanying unaudited consolidated balance sheet as of June 30, 2016, consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2015 and 2016, and consolidated statements of cash flows for the six months ended June 30, 2015 and 2016 are unaudited. The interim unaudited consolidated financial statements have been prepared on the same basis as the annual audited financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair presentation of our financial position as of June 30, 2016 and the results of our operations and comprehensive loss for the three and six months ended June 30, 2015 and 2016, and our cash flows for the six months ended June 30, 2015 and 2016. The financial data and other information disclosed in these notes as of June 30, 2016 and for the three and six months ended June 30, 2015 and 2016 are unaudited. The results for the three and six months ended June 30, 2016 are not necessarily indicative of results to be expected for the year ending December 31, 2016, any other interim periods, or any future year or period.
Recent Accounting Pronouncements
In February 2016, the Financial Accounting Standards Board (FASB) issued
Accounting Standards Update (ASU)
No. 2016-02, Leases (Topic 842) (ASU 2016-02). The new standard establishes a right-of-use (ROU) model that requires a lessee to record a ROU asset and a lease liability on the balance sheet for all leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. ASU 2016-02 is effective for annual periods beginning after December 15, 2018, including interim periods within those annual periods, with early adoption permitted. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements, with certain practical expedients available. The Company is currently evaluating the impact that the standard will have on the financial statements.
In January 2016, the FASB issued Accounting Standards Update No. 2016-01, Financial Statements—Overall (Subtopics 825-10)(“ASU 2016-01”). ASU 2016-01 provides updated guidance on the recognition and measurement of financial assets and financial liabilities that will supersede most current guidance. ASU 2016-01 primarily affects the accounting for equity investments, financial liabilities under the fair value option, and the presentation and disclosure requirements for financial instruments. The amendments in ASU 2016-01 supersede the guidance to classify equity securities with readily determinable fair values into different categories and require equity securities to be measured at fair value with changes in the fair value recognized through net income. The amendments under ASU 2016-01 are effective, for public business entities, for periods beginning after December 15, 2017, including interim periods within those fiscal years, and with early adoption permitted. The Company does not expect the adoption of ASU 2016-01 to have a material impact on its results of operations, financial position or cash flows.
In November 2015, the FASB issued ASU 2015-17,
Income Taxes: Balance Sheet Classification of Deferred Taxes (ASU 2015-17).
ASU 2015-17 simplifies the balance sheet classification of deferred taxes and requires that all deferred taxes be presented as noncurrent. ASU 2015-17 is effective for fiscal years beginning after December 15, 2016 with early adoption permitted.
The adoption of this update is not expected to have a material effect on the Company’s financial statements.
In August 2014, the FASB issued ASU No. 2014-15,
Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern
(ASU 2014-15), to provide guidance on management’s responsibility in evaluating whether there is substantial doubt about a company’s ability to continue as a going concern and to provide related footnote disclosures. ASU 2014-15 is effective for the Company for annual periods beginning after December 15, 2016 and for interim periods after that, with early adoption permitted. The Company is currently evaluating the impact of adopting ASU 2014-15 on its consolidated financial statements.
Use of Estimates
The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from such estimates.
In March 2016, we sold all of our laboratory equipment for proceeds of $152,756, which resulted in a loss on sale of equipment of $153,572 during the six months ended June 30, 2016.
6. Notes Payable
8% Convertible Senior Notes Due 2019
On June 23, 2014, we issued through a private placement $47.0 million in aggregate principal amount of 8% convertible senior notes due June 15, 2019 (the “8% Notes”), of which $43.75 million remain outstanding as of June 30, 2016. Interest on the 8% Notes is payable semi-annually in arrears on June 15 and December 15 of each year, commencing December 15, 2014.
The 8% Notes are general unsecured and unsubordinated obligations and will rank senior in right of payment to all of our indebtedness that is expressly subordinated in right of payment to the notes, rank equal in right of payment to our existing and future indebtedness and other liabilities that are not so subordinated, are effectively subordinated to any of our future secured indebtedness to the extent of the value of the assets securing such indebtedness, and rank structurally junior to all indebtedness and other liabilities incurred by our subsidiaries, including trade payables. We may not redeem the 8% Notes at our option prior to maturity based on the terms of the indenture. The 8% Notes are convertible prior to maturity, subject to certain conditions described below, into shares of our common stock at an initial conversion rate of 148.3019 shares per $1,000 principal amount of the 8% Notes (equivalent to an initial conversion price of approximately $6.74 per share of common stock). This conversion rate is subject to adjustment upon the occurrence of certain specified events but will not be adjusted for accrued and unpaid interest. We may satisfy our conversion obligation by paying or delivering, as the case may be, cash, shares of our common stock or a combination thereof, at our election.
The Holders of the 8% Notes may surrender their notes for conversion any time prior to the close of business immediately preceding February 15, 2019 only if any of the following conditions is satisfied:
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·
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during any fiscal quarter (and only during such fiscal quarter) commencing after December 31, 2015, if, for at least 20 trading days (whether or not consecutive) during the 30 consecutive trading day period ending on the last trading day of the immediately preceding fiscal quarter, the last reported sale price of our common stock for each such trading day is greater than or equal to 100% of the applicable conversion price on such trading day;
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·
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during the five consecutive business day period immediately following any 10 consecutive trading day period, or the “measurement period”, in which, for each trading day of such measurement period, the “trading price” per $1,000 principal amount of notes for such trading day was less than 98% of the product of the last reported sale price of our common stock for such trading day and the applicable conversion rate on such trading day; or
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·
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upon the occurrence of specified corporate events.
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Holders also may surrender their 8% Notes for conversion at any time on or after February 15, 2019 and on or prior to the close of business on the business day immediately prior to the stated maturity date regardless if any of the foregoing conditions have been satisfied. As of December 31, 2015 and June 30, 2016, the 8% Notes were not convertible.
Each $1,000 principal amount of 8% Notes is convertible into shares of our common stock equal to the conversion rate in effect on the conversion date, together with cash in lieu of fractional shares issuable upon conversion. We may deliver upon conversion cash, shares, or a combination thereof, at our election. With respect to any conversions, settlement amounts will be computed as follows:
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·
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if we elect (or are deemed to have elected) physical settlement, we will deliver to the converting holder in respect of each $1,000 principal amount of notes being converted a number of shares of common stock equal to the conversion rate in effect on the conversion date together with cash in lieu of fractional shares issuable upon conversion and the interest make-whole payment, if applicable;
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The equity component is also recorded as debt discount and amortized as interest expense over the expected term of the 8% Notes. The carrying value of our 8% Notes is net of debt discount of $12,785,423 and $15,471,125 at June 30, 2016 and December 31, 2015, respectively.
The liability component of the 8% Notes on the date of issuance was computed as $30.8 million, consisting of the value of the embedded interest make-whole derivative of $3.1 million and the carrying value of the 8% Notes of $27.7 million. Accordingly, the equity component on the date of issuance was $16.2 million. The discount on the 8% Notes is being amortized to interest expense over the term of the Notes, using the effective interest method.
The liability component of our convertible notes will be classified as current liabilities and presented in current portion of long-term debt and the equity component of our convertible debt will be considered a redeemable security and presented as redeemable equity on our consolidated balance sheet if our debt is considered current at the balance sheet date. As of December 31, 2015 and June 30, 2016, the 8% Notes were classified as long-term liabilities.
Transaction costs of $2.9 million related to the issuance of the 8% Notes were allocated to the liability and equity components in proportion to the allocation of the proceeds and accounted for as deferred financing costs and equity issuance costs, respectively. Approximately $1.0 million of this amount was allocated to equity and the remaining $1.9 million have been capitalized as deferred financing costs and are being amortized over the term of the 8% Notes.
In March 2015, we agreed to exchange $3.25 million aggregate principal amount of our 8% Notes in separately negotiated transactions for cash payments totaling $0.8 million and the issuance of 0.5 million shares of our common stock. We recognized $0.8 million of debt exchange expense for the three months ended June 30, 2015 in connection with these exchanges, which represents the additional consideration (cash and shares) that was provided to these noteholders pursuant to their exchange agreements.
The following table summarizes how the 8% Notes are reflected in our balance sheet at June 30, 2016:
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June 30, 2016
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Face value of outstanding notes
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$
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43,750,000
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|
|
Conversion option reported in equity
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|
(15,002,020)
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|
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Interest make-whole derivative
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|
(2,889,043)
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|
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Unamortized debt issuance costs
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|
(1,039,374)
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|
|
Cumulative amortization of debt discount
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5,105,640
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Carrying value
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$
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29,925,203
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The following table sets forth our interest expense incurred for the three and six months ended June 30, 2015 and 2016:
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|
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Three months ended June 30,
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Six Months Ended June 30,
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|
|
|
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2015
|
|
2016
|
|
2015
|
|
2016
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8% Convertible Senior Notes due 2019 - coupon
|
|
$
|
875,000
|
|
$
|
875,000
|
|
$
|
1,738,445
|
|
$
|
1,750,000
|
|
|
8% Convertible Senior Notes due 2019 - amortization of debt discount
|
|
|
611,455
|
|
|
756,093
|
|
|
1,219,761
|
|
|
1,473,099
|
|
|
Amortization of deferred financing costs
|
|
|
86,615
|
|
|
86,614
|
|
|
178,123
|
|
|
173,229
|
|
|
|
|
$
|
1,573,070
|
|
$
|
1,717,707
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|
$
|
3,136,329
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|
$
|
3,396,328
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7. Stockholders’ Equity
Common Stock
We are authorized to issue 100,000,000 shares of common stock, with a par value of $0.0001, or Common Stock, of which 24,769,083 were issued and outstanding at December 31, 2015 and June 30, 2016.
At the Market Offering
On March 13, 2015, we entered into a Sales Agreement with Guggenheim Securities, LLC, or Guggenheim, to offer shares of our Common Stock from time to time through Guggenheim, as our sales agent for the offer and sale of the
shares. We may offer and sell shares for an aggregate offering price of up to $25 million. We did not make any sales under the Sales Agreement during the three and six months ended June 30, 2015 and 2016.
Purchase Agreement
On August 24, 2015, we entered into a purchase agreement (the “Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“LPC”), pursuant to which we have the right to sell to LPC up to $17,000,000 in shares of our Common Stock, subject to certain limitations and conditions set forth in the Purchase Agreement, over the period from August 24, 2015 to March 1, 2018.
As consideration for entering into the Purchase Agreement, we issued to LPC 103,364 shares of Common Stock on the date of the Purchase Agreement. As consideration for LPC’s purchase of up to an additional $15,000,000 in shares of Common Stock, we will issue up to 34,455 shares of Common Stock to LPC on a pro-rata basis on each purchase date. We will not receive any cash proceeds from the issuance of these shares.
Under the Purchase Agreement, on any business day and as often as every business day over the 30-month term of the Purchase Agreement, and up to an aggregate amount of an additional $15,000,000 (subject to certain limitations) in shares of Common Stock, we have the right at our sole discretion and subject to certain conditions to direct LPC to purchase up to 100,000 shares of Common Stock (with such amounts increasing up to 175,000 shares as the stock price increases, but not to exceed $1,000,000 in total purchase proceeds per purchase date). The purchase price of shares of Common Stock pursuant to the Purchase Agreement will be based on the prevailing market price at the time of sale as set forth in the Purchase Agreement. We will control the timing and amount of any sales of Common Stock to LPC. In addition, we may direct LPC to purchase additional amounts as accelerated purchases if on the date of a regular purchase the closing sale price of the Common Stock is not below the “threshold price” as set forth in the Purchase Agreement. We have the right to terminate the Purchase Agreement at any time, on one business days’ notice, at no cost or penalty. We have agreed with LPC that we will not enter into any “variable rate” transactions with any third party from the date of the Purchase Agreement until the expiration of the 30-month period following the date of the Purchase Agreement, subject to certain exceptions.
From the effective date of the Purchase Agreement through December 31, 2015, we issued a total of 1,435,612 shares of Common Stock to LPC, including 105,379 shares of Common Stock issued to LPC as consideration for entering into the Purchase Agreement and purchasing additional shares, for gross proceeds of $2.9 million. We did not issue any shares under the Purchase Agreement during the three and six months ended June 30, 2016.
Stock-based compensation expense
Stock-based payments to employees, including grants of employee stock options, are recognized in the statements of operations and comprehensive loss based on fair value. Stock-based payments to non-employees are recognized at fair value on the date of grant and re-measured at each subsequent reporting date through the settlement of the instrument.
Stock-based compensation expense recognized by award type is as follows:
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|
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|
|
|
|
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Three Months Ended
|
|
Six months ended
|
|
|
|
June 30,
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|
June 30,
|
|
|
|
2015
|
|
2016
|
|
2015
|
|
2016
|
|
Options awards
|
|
$
|
1,233,950
|
|
$
|
618,896
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|
$
|
2,561,157
|
|
$
|
1,659,704
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|
Restricted stock awards
|
|
|
59,063
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|
|
(55,781)
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|
|
352,687
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|
|
(167,344)
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|
Total stock-based compensation expense
|
|
$
|
1,293,013
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|
$
|
563,115
|
|
$
|
2,913,844
|
|
$
|
1,492,360
|
ITEM 2. MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion and analysis of our financial condition and results of operations together with our consolidated financial statements and related notes appearing in this report, and in conjunction with our financial statements included in the Annual Report. Some of the information contained in this discussion and analysis or set forth elsewhere in this report, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in under the caption “Cautionary Note Regarding Forward-Looking Statements and Industry Data” in this quarterly report and Part I, Item 1A “Risk Factors” of the Annual Report, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.
Overview
We are a clinical-stage biopharmaceutical company focused on developing novel small molecule therapeutics in oncology, infectious diseases and autoimmune diseases. We currently have two clinical-stage product candidates in development: birinapant and SHAPE. In May 2015, we halted a birinapant chronic hepatitis B virus, or HBV, clinical trial in Australia, and in January 2016 we terminated the birinapant myelodysplastic syndromes, or MDS, clinical trial due to negative results in the trial.
In July 2015, we announced that we intend to initiate a combination single ascending dose/multiple ascending dose clinical trial, with birinapant as a single agent, in chronic HBV subjects in India. We
submitted a phase 2 study proposal of birinapant in patients with chronic hepatitis B for review by the Indian regulatory authorities. The Indian Subject Expert Committee (the “Committee”), Gastroenterology and Hepatology met on April 19, 2016 to discuss the proposed study. The Committee stated that they could not recommend this trial to the Indian regulatory authorities at this time. We are continuing to interface with the Indian regulatory authorities to explore a path forward for this study, as well as considering alternative opportunities for this study in other geographical regions. The commencement of this study is also dependent on our ability to obtain the necessary funds to perform the study.
The recent negative results from our MDS clinical trial with birinapant has seriously damaged our ability to raise new financing in the near future. If we are unable to obtain necessary financing, our ability to complete the development and potential commercialization of our product candidates will be compromised and we will need to downsize or wind down our operations through liquidation, bankruptcy or a sale of our company or our assets. We cannot assure you that we will be able to obtain additional financing on terms we deem to be commercially reasonable, if at all or that the third-party financing that we do obtain will be sufficient to cover our operating expenses, debt expenses and other payment obligations. If we fail to obtain the third-party financing we require, we may be unable to continue our operations at the planned levels or at all. We may then have to sell our company or our assets or file for, or be forced to resort to, bankruptcy protection or liquidation.
In January 2016, our board of directors authorized a reduction in our staff which reduced our head count to 9 employees in April 2016. Our Chief Scientific Officer and our Chief Operating Officer were included in those reductions. As a result of these reductions, we recorded a one–time restructuring charge of $2.0 million in the first quarter of fiscal 2016. In April 2016, our Chief Financial Officer resigned, which reduced our head count to the current level of 8 employees.
See Footnote 1 for a discussion of our Nasdaq delisting notices and their effect on our future liquidity.
The report of our independent registered public accounting firm on our financial statements for the year ended December 31, 2015 contains explanatory language that substantial doubt exists about our ability to continue as a going concern, without raising additional capital. In addition, the report notes that the 8% Notes may become due and payable during 2016 should our common stock be delisted from the Nasdaq Global Market.
We have retained Houlihan Lokey Capital, Inc. as our financial advisor, to provide financial advisory, restructuring and investment-banking services in connection with analyzing and considering a wide range of transactional and strategic alternatives. We are currently negotiating the potential sale of one or both of our primary molecules, birinapant and Shape, to a third-party purchaser. We are also currently in active discussions with the noteholders of our 8% Notes regarding the possible early conversion of our 8% Notes into equity. We can give no
assurance that either of these transactions will occur.
SHAPE is our proprietary histone deacetylase, or HDAC, inhibitor that we are developing for topical use for the treatment of early-stage cutaneous T-cell lymphoma, or CTCL, and we are exploring studying SHAPE in alopecia areata, an autoimmune skin disease resulting in the loss of hair on the scalp and elsewhere on the body. SHAPE has been granted U.S. orphan drug designation for CTCL. CTCL is a form of non-Hodgkin T-cell lymphoma which primarily manifests in the skin. The majority of CTCL cases are indolent; however, there are rare cases of CTCL that are aggressive and life-threatening. HDAC is a validated cancer target, and HDAC inhibitors, or HDACi, are a proven class of anti-cancer drugs for CTCL. SHAPE is a novel therapeutic, designed to maximize HDAC inhibition locally in the skin with limited systemic exposure, and it has characteristics that could allow its topical use over large body surface areas with minimal systemic absorption. By potentially avoiding toxicities typical of systemically-administered HDACi’s, SHAPE may provide a more favorable safety profile than current HDACi’s delivered orally or intravenously. SHAPE has been evaluated in a randomized, placebo-controlled dose escalation Phase 1 clinical trial in early-stage CTCL. SHAPE was well-tolerated, and it demonstrated evidence of clinical activity with partial responses, or PRs, observed in certain subjects after 28 days of application.
On January 6, 2016, we announced that we had undertaken an interim analysis of our randomized Phase 2 clinical trial of SHAPE. The clinical trial was designed to investigate the safety and efficacy of three different dosing regimens of SHAPE in patients suffering from earlier stage CTCL. All patients in the clinical trial had received prior therapy either in the form of topical steroids, UV light therapy, topical nitrogen mustard, or some other agent. Twenty-eight of 34 patients were evaluable for response at the six month time point. Within six months of treatment, twelve of 34 patients exhibited a response to treatment as assessed by the Composite Assessment of Index Lesion Severity, or CAILS, the primary endpoint, and a further 21 had stable disease. Using the modified Severity Weighted Assessment Tool, or mSWAT, a secondary endpoint in the clinical trial, 14 of 34 patients responded and a further 20 patients had stable disease within the six month treatment period.
The interim results taken during this Phase 2 clinical trial demonstrated that SHAPE also showed improvement in pruritus (itch), a significant symptom associated with CTCL. Forty-five percent of all patients enrolled in the trial entered with significant pruritus at baseline as defined by VAS score. Of these, 50% saw a clinically meaningful reduction in pruritus. In addition, the pruritus response appeared to be dose dependent, and all 8 patients on the highest dose arm experienced a clinically meaningful reduction in pruritus. SHAPE was well tolerated by patients in the clinical trial.
We have undertaken a final analysis of our randomized Phase 2 clinical trial of SHAPE. Sixty patients were evaluable for response. In total, nineteen patients exhibited a response to treatment as assessed by CAILS, the primary endpoint, and a further 40 had stable disease. Under the 1% SHAPE twice-daily dosing regimen, seven of 19 patients exhibited a response to treatment as assessed by CAILS, and the remaining 12 patients had stable disease. In addition, the final results continued to demonstrate improvement in pruritus, with 54% of all patients that entered the trial with significant pruritus at baseline showing improvement, and 80% of such patients under the 1% SHAPE twice-daily dosing regimen showing improvement. One of the principal objectives of this study was to identify the optimal dose to carry forward into a Phase 3 clinical trial. Based upon the data from our study, we believe that the dose which demonstrates the best combination of safety and efficacy is the 1% SHAPE administered twice daily. We intend to schedule an end of Phase 2 meeting with the FDA to discuss these results and the potential design for a Phase 3 clinical trial. The commencement of this trial will also be dependent on our ability to obtain the necessary funds for this trial.
SHAPE’s composition of matter patent in the U.S. extends until at least 2028. We have acquired worldwide development and commercialization rights to SHAPE for all indications.
Birinapant
is a novel small molecule therapeutic that mimics Second Mitochondrial Activator of Caspases, or SMAC-mimetic, which leads to apoptosis, or cell-death, in damaged cells. I
n June 2014, we commenced a randomized, double-blind placebo-controlled Phase 2 clinical trial of birinapant administered with azacitidine in subjects with previously untreated, higher risk MDS. On January 6, 2016, we announced interim results from this study in which birinapant did not demonstrate clinical benefit over placebo on the primary endpoint of response rate after four months of therapy and met the bounds for futility. This interim analysis included the first 62 patients randomized in the trial. As a result,
the MDS clinical trial was terminated as of January 6, 2016.
We have generated pre-clinical data indicating that birinapant induces apoptosis in-vivo in mouse hepatocytes infected with HBV. In a mouse model, we have seen clearance of HBV surface antigen, or HBsAg, and the appearance of antibodies directed against HBsAg, a clinical finding considered equivalent to a functional cure. We have also seen activity of birinapant in other infectious disease models, including human mononuclear cells infected with human immunodeficiency virus, or HIV, in-vitro, and in-vivo in mouse models of Mycobacterium tuberculosis and Legionella pneumophila.
In May 2015,
we halted
the birinapant chronic HBV multiple ascending dose trial being conducted in Australia due to cranial nerve palsies observed in the first cohort. In July 2015, we announced that we intend to initiate a combination single ascending dose/multiple ascending dose clinical trial, with birinapant as a single agent, in chronic HBV subjects in India.
We submitted a phase 2 study proposal of birinapant in patients with chronic hepatitis B for review by the Indian regulatory authorities. The Indian Subject Expert Committee (the “Committee”), Gastroenterology and Hepatology met on April 19, 2016 to discuss the proposed study. The Committee stated that they could not recommend this trial to the Indian regulatory authorities at this time. We are continuing to interface with the Indian regulatory authorities to explore a path forward for this study, as well as considering alternative opportunities for this study in other geographical regions. The commencement of this study is also dependent on our ability to obtain the necessary funds to perform the study.
In April 2015, we entered into a clinical study collaboration agreement with Merck & Co. (“Merck”) to perform a Phase 1 dose-escalation study to evaluate the safety and efficacy of birinapant in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with relapsed or refractory solid tumors. We will sponsor and fund the clinical trial and Merck will supply KEYTRUDA®. Results from the clinical trial will be used to determine the path for further clinical development of the combination. In addition, we have entered into a collaboration with The University of California, Los Angeles (“UCLA”) School of Medicine to perform a Phase 2 study to evaluate the safety and efficacy of birinapant plus standard of care platinum based therapy, in patients with high grade serous ovarian cancer. The study is based on preclinical research conducted at UCLA and led by Sanaz Memarzadeh, MD, PhD, associate professor and gynecologic cancer surgeon at the UCLA Broad Stem Cell Research Center, UCLA School of Medicine. Both the Merck study and the UCLA study may commence in the coming months subject to our ability to obtain the necessary funds to perform the studies.
We discovered birinapant, and its composition of matter patent in the U.S. extends until at least 2030. We have retained worldwide development and commercialization rights for all indications.
We are also exploring strategic alternatives with respect to birinapant, including the potential out-licensing of birinapant to interested partners.
We have incurred operating losses since inception, have not generated any product sales revenues and have not achieved profitable operations. Our accumulated deficit through June 30, 2016 was $193.4 million, and we expect to continue to incur substantial losses in future periods.
We incurred research and development expenses of $7.7 million, $1.5 million, $14.2 million and $4.8 million during the three months ended June 30, 2015 and 2016, and the six months ended June 30, 2015 and 2016, respectively. We anticipate that a significant portion of our operating expenses will continue to be related to research and development as we continue to advance our clinical-stage product candidates, birinapant and SHAPE. We funded our operations as a private company primarily through the sale of preferred stock and the issuance of convertible notes for gross proceeds totaling $85.4 million, which have been converted into shares of our Common Stock in connection with our initial public offering. We also received amounts under collaboration and grant arrangements totaling $13.7 million. In December 2013 we sold 8,222,115 shares of Common Stock in our initial public offering for net proceeds of $49.1 million after payment of underwriting fees and other expenses, and in June 2014 we issued convertible notes for proceeds of $44.1 million, net of underwriting fees and other expenses. In 2015 we sold 1,435,612 shares of Common Stock under a purchase agreement with
Lincoln Park Capital Fund, LLC (“LPC”) for net proceeds of $2.6 million.
As of December 31, 2015 and June 30, 2016, we had $20.4 million and $8.7 million in cash, cash equivalents and short-term investments, respectively.
We are highly dependent on the success of our research, development and licensing efforts and, ultimately, upon regulatory approval and market acceptance of birinapant and SHAPE. Our short- and long-term capital requirements depend upon a variety of factors, including, but not limited to:
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initiation, progress, timing, costs and results of pre-clinical studies and clinical trials for birinapant, SHAPE or any other future product candidates;
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clinical development plans we establish for birinapant, SHAPE and any other future product candidates;
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our obligation to make royalty and non-royalty sublicense receipt payments to third-party licensors, if any, under our licensing agreements;
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number and characteristics of product candidates that we discover or in-license and develop;
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outcome, timing and cost of regulatory review by the FDA and comparable foreign regulatory authorities, including the potential for the FDA or comparable foreign regulatory authorities to require that we perform more studies than those that we currently expect;
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costs of filing, prosecuting, defending and enforcing any patent claims and maintaining and enforcing or defending other intellectual property rights;
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effect of competing technological and market developments;
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costs and timing of the implementation of commercial-scale manufacturing activities;
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costs and timing of establishing sales, marketing and distribution capabilities for birinapant, SHAPE and any other future product candidates for which we may receive regulatory approval; and
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whether we are able to maintain our listing under Nasdaq.
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The following discussion and analysis provides information that we believe is relevant to an assessment and understanding of our results of operations for the three and six months ended June 30, 2015 and 2016, and our financial condition as of December 31, 2015 and June 30, 2016.
Critical Accounting Policies and Significant Judgments and Estimates
Our critical accounting policies and significant judgments and estimates are disclosed in our Annual Report. Since the date of those financial statements, there have been no changes to our critical accounting policies and significant judgments and estimates.
Financial Overview
Revenue
We have not generated any revenue from commercial product sales since we commenced operations. In the future, if either birinapant or SHAPE is approved for commercial sale, we may generate revenue from product sales, or alternatively, we may choose to select a collaborator or licensee to commercialize birinapant or SHAPE.
General and Administrative Expenses
General and administrative expenses consist principally of salaries and related costs for executive and other administrative personnel, including stock-based compensation and travel expenses. Other general and administrative expenses include professional fees for legal, patent review, consulting and accounting services. General and administrative expenses are expensed when incurred.
For the three months ended June 30, 2015 and 2016, and the six months ended June 30, 2015 and 2016, our general and administrative expenses totaled $2.9 million, $2.4 million, $6.0 million and $5.4 million, respectively. The decrease in general and administrative expenses from the three months ended June 30, 2015 to the three months ended June 30, 2016 is due to a decrease in personnel and stock compensation expenses resulting from our reduction in staff implemented in the first quarter of 2016, offset by an increase in financial advisory expenses related to our exploration of strategic alternatives during 2016. The decrease in general and administrative expenses from the six months ended June 30, 2015 to the six months ended June 30, 2016 is due to the changes in personnel, stock compensation, and financial advisory expenses noted above, also offset by an increase in patent legal expenses in 2016 as compared to 2015.
Research and Development Expenses
Our research and development expenses have consisted primarily of costs incurred for the development of our product candidates, which include:
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employee-related expenses, including salaries, benefits, travel and stock-based compensation expense;
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expenses incurred under agreements with CROs and investigative sites that conduct our clinical trials and pre-clinical studies;
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the cost of acquiring, developing and manufacturing clinical trial materials;
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facilities, depreciation and other expenses, which include direct and allocated expenses for rent and maintenance of facilities, insurance and other supplies; and
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costs associated with pre-clinical activities and regulatory operations.
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Research and development costs are expensed when incurred. We record costs for some development activities, such as clinical trials, based on an evaluation of the progress to completion of specific tasks using data such as subject enrollment, clinical site activations or information provided to us by our vendors.
During the three months ended June 30, 2015 and 2016, and the six months ended June 30, 2015 and 2016, we incurred $7.7 million, $1.5 million, $14.2 million and $4.8 million, respectively, in research and development expenses. Research and development expenses decreased for both the three and six months ended June 30, 2016 as compared to the three and six months ended June 30, 2015, due to decreases in clinical trial expenses for all indications, decreases in manufacturing, product development, and pre-clinical expenses, and decreases in personnel and stock compensation expenses resulting from the reduction in force implemented in the first quarter of 2016. The MDS trial was terminated in January 2016 due to disappointing results. The HBV trial was temporarily halted in May 2015. We completed enrollment in the Phase 1/2 open-label, non –randomized clinical trial of birinapant administered with conatumumab in third-line ovarian cancer trial in the second quarter of 2015, and based on results observed to date, we do not expect to advance this program beyond this study at this time.
Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We do not currently utilize a formal time allocation system to capture expenses on a project-by-project basis as the majority of our past expenses have been in support of birinapant, and our future expenses will be in support of birinapant and SHAPE. However, we do allocate some portion of our research and development expenses by functional area, as shown below.
The following table summarizes our research and development expenses for the three and six months ended June 30, 2015 and 2016:
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Three Months Ended
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Six Months Ended
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June 30,
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June 30,
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2015
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2016
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2015
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2016
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Clinical development
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$
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3,771,017
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$
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822,965
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$
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6,502,073
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$
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2,930,426
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Manufacturing and formulation
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1,163,315
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(8,620)
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1,916,661
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151,156
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Personnel related
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1,708,823
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656,628
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3,479,485
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1,653,879
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Stock-based compensation
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347,281
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27,588
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816,959
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64,639
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Consulting
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118,185
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—
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343,212
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—
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Other research and non-clinical development
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601,177
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—
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1,097,601
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—
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$
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7,709,798
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$
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1,498,561
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$
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14,155,991
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$
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4,800,100
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The following table summarizes our research and development expenses by targeted indication for the three and six months ended June 30, 2015 and 2016:
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Three Months Ended
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Six Months Ended
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June 30,
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June 30,
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2015
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2016
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2015
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2016
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Blood cancers (MDS)
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$
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4,087,522
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$
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563,732
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$
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7,454,556
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$
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2,834,155
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Solid tumors
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700,665
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—
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1,363,861
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—
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Infectious diseases (HBV)
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753,511
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—
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1,148,455
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—
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Shape (CTCL)
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1,330,787
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934,829
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2,547,942
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1,965,945
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Other pre-clinical and non-indication specific
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837,313
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—
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1,641,177
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—
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$
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7,709,798
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$
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1,498,561
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$
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14,155,991
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$
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4,800,100
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We will need to secure additional funding in the future in order to carry out all of our planned research and development activities with respect to our product candidates. We will incur substantial costs beyond our present and planned clinical trials in order to file NDAs in target indications for both birinapant and SHAPE, and in each case, the nature, design, size and cost of further studies and trials will depend in large part on the outcome of preceding studies and trials and discussions with regulators.
It is difficult to determine with certainty the costs and duration of our current or future clinical trials and pre-clinical studies, or if, when or to what extent we will generate revenues from the commercialization and sale of our product candidates if we obtain regulatory approval. We may never succeed in achieving regulatory approval for our product candidates. The duration, costs and timing of clinical trials and development of our product candidates will depend on a variety of factors, including the uncertainties of future clinical trials and pre-clinical studies, uncertainties in clinical trial enrollment rate and significant and changing government regulation.
In addition, the probability of success for our product candidates will depend on numerous factors, including competition, manufacturing capability and commercial viability. See Risk Factors below and in Part I, Item 1A of our Annual Report.
Market acceptance of our product candidates, if we receive approval, depends on a number of factors, including the:
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efficacy and safety of our product candidates administered alone or with other drugs, and post-marketing experience of the drugs;
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clinical indications for which our product candidates are approved;
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acceptance by physicians, major operators of cancer or infectious disease clinics and patients of our product candidates as safe and effective treatments;
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potential and perceived advantages of our product candidates over alternative treatments;
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prevalence and severity of any side effects;
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product labeling or package insert requirements of the FDA or other regulatory authorities;
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timing of market introduction of our product candidates as well as competitive products;
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cost of treatment in relation to alternative treatments;
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availability of coverage and adequate reimbursement and pricing by third-party payors and government authorities;
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relative convenience and ease of administration; and
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effectiveness of our sales and marketing efforts.
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We will determine which programs to pursue and how much to fund each program in response to the scientific and clinical success of our product candidates, as well as an assessment of their commercial potential.
Restructuring charge
On January 19, 2016, we authorized the implementation of a 19 person reduction in staff to control operating expenses and reduce ongoing cash requirements. The actions associated with the reductions were completed in April 2016. These termination benefits consist of a severance payment equal to 3 months’ salary or, in the case of certain senior executives, consist of benefits pursuant to the provisions of their employment agreements, and outplacement assistance. The estimated liability for termination benefits which will be paid out over 18 months was recorded at fair value during the first quarter of 2016. As a result of the reductions and the accretion of the liability, we recorded restructuring charges of $29.0 thousand and $2.0 million for the three and six months ended June 30, 2016, respectively.
Change in fair value of contingent consideration
The acquisition of Shape includes a contingent consideration arrangement that may require us to pay additional consideration in the form of milestone payments and tiered royalties. We recorded the liability for the contingent consideration based on its fair value on the date of the acquisition, and we record any change in fair value of the contingent consideration in our consolidated statements of operations and comprehensive loss as a change in fair value of contingent consideration included in loss from operations. For the three months ended June 30, 2015 and 2016, and the six months ended June 30, 2015 and 2016, we recorded a change in fair value of contingent consideration of $1.1 million, $1.1 million, $2.1 million and $2.2 million, respectively. The change in fair value of the contingent consideration recorded for the three and six months ended June 30, 2015 and 2016 was due primarily to accretion related to the passage of time.
Change in fair value of derivative liabilities
Certain of our warrants to purchase our Common Stock are classified as derivative liabilities and recorded at fair value. These derivative liabilities are subject to re-measurement at each balance sheet date and we recognize any change in fair value in our consolidated statements of operations and comprehensive loss as a change in fair value of the derivative liability. For the three months ended June 30, 2015 and 2016, and the six months ended June 30, 2015 and 2016, we recorded a change in fair value of these derivative liabilities of $0.1 million, $0, $0.2 million and $0.1 million, respectively. The change in the fair value of these derivative liabilities is due primarily to the decrease in the value of our Common Stock during those periods.
We have classified the interest make-whole provision of our 8% Notes due 2019 issued in June 2014 as a derivative liability that is recorded at fair value. This derivative liability is subject to re-measurement at each balance sheet date and we recognize any change in fair value in our consolidated statements of operations and comprehensive loss as a change in fair value of the derivative liability. For the three months ended June 30, 2015 and 2016, and the six months ended June 30, 2015 and 2016, we recorded a change in fair value of this derivative liability of $1.2 million,
$(17,000), $1.4 million and $13,000, respectively. The change in the fair value of this derivative liability is due primarily to the change in the value of our Common Stock during those periods.
Interest and Other Income
Interest and other income consist principally of interest income earned on cash and cash equivalent balances.
Loss on sale of equipment
In March 2016, we sold all of our laboratory equipment with a net book value of $306,000 for net proceeds after selling costs of $152,000, resulting in a loss on sale of equipment of $154,000.
Interest Expense
Interest expense for the three months ended June 30, 2015 and 2016, and the six months ended June 30, 2015 and 2016, was $1.6 million, $1.7 million, $3.1 million and $3.4 million, respectively. This interest expense is attributable to coupon interest on our 8% Notes and to non-cash interest expense resulting from the accretion of the debt discount and beneficial conversion feature associated with our 8% Notes issued in June 2014.
Cash Flows
Operating Activities.
Cash used in operating activities during the six months ended June 30, 2016 decreased to $11.9 million from $18.0 million used in the six months ended June 30, 2015. This decrease was driven primarily by lower operating costs in 2016 as compared to 2015.
Investing Activities.
Cash provided by investing activities was $5.3 million for the six months ended June 30, 2016 as compared to cash provided by investing activities of $18.2 million for the six months ended June 30, 2015. Cash provided by investing activities for 2015 and 2016 is attributable primarily to the excess of maturities over purchases of short-term investments during the period.
Financing Activities.
There were no cash flows from financing activities during the six months ended June 30, 2016. Cash used in financing activities was $0.8 million for the six months ended June 30, 2015, due primarily to payments made to retire convertible notes during the period.
JOBS Act
We are an “emerging growth company” under Section 107 of the JOBS Act. As an emerging growth company, we can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. In other words, an “emerging growth company” can delay the adoption of new or revised accounting standards until those standards would otherwise apply to private companies. We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards and, therefore, we will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.
Liquidity and Capital Resources
Since our inception, we have incurred net losses and negative cash flows from our operations. We incurred net losses of $11.9 million, $6.7 million, $24.6 million and $17.8 million for the three months ended June 30, 2015 and 2016, and the six months ended June 30, 2015 and 2016, respectively. Our operating activities used $18.0 million and $11.9 million of cash flows during the six months ended June 30, 2015 and 2016, respectively. At June 30, 2016, we had an accumulated deficit of $193.4 million, a working capital deficit of $2.4 million and cash and cash equivalents of $8.7 million. We funded our operations as a private company primarily through the sale of preferred stock and the issuance of convertible notes for gross proceeds totaling $85.4 million, which were converted into shares of our Common Stock in connection with our initial public offering. We also received amounts under collaboration and grant arrangements totaling $13.7 million. In December 2013 we sold 8,222,115 shares of Common Stock in our initial public offering for net proceeds of $49.1 million after payment of underwriting fees and other expenses, and in June 2014 we issued our 8%
Notes for proceeds of $44.1 million, net of underwriting fees and other expenses. In 2015 we sold 1,435,612 shares of Common Stock under a purchase agreement with
LPC for net proceeds of $2.6 million.
On June 23, 2014, we issued through a private placement $47.0 million in aggregate principal amount of our 8% Notes, of which $43.75 million remain outstanding as of June 30, 2016. Interest on our 8% Notes is payable semi-annually in arrears on June 15 and December 15 of each year, which commenced December 15, 2014. Our 8% Notes are general unsecured and unsubordinated obligations and rank senior in right of payment to all of our indebtedness that is expressly subordinated in right of payment to the notes, rank equal in right of payment to our existing and future indebtedness and other liabilities that are not so subordinated, are effectively subordinated to any of our future secured indebtedness to the extent of the value of the assets securing such indebtedness, and rank structurally junior to all indebtedness and other liabilities incurred by our subsidiaries, including trade payables. We may not redeem our 8% Notes at our option prior to maturity. Our 8% Notes are convertible prior to maturity, subject to certain conditions described below, into shares of our common stock at an initial conversion rate of 148.3019 shares per $1,000 principal amount of our 8% Notes (equivalent to an initial conversion price of approximately $6.74 per share of common stock). This conversion rate is subject to adjustment upon the occurrence of certain specified events but will not be adjusted for accrued and unpaid interest. We may satisfy our conversion obligation by paying or delivering, as the case may be, cash, shares of our common stock or a combination thereof, at our election. See Note 6 to Notes to Consolidated Financial Statements for additional information. The indenture for our 8% Notes contains certain covenants which limit our and our subsidiaries’ ability to incur certain additional indebtedness except for certain permitted debt, and to incur liens except for certain permitted liens. We are in compliance with all the covenants set forth in the indenture governing our 8% Notes.
In April 2014, we acquired by merger Shape Pharmaceuticals, a development stage
pharmaceutical company developing SHAPE. We acquired this company to add a second clinical-stage oncology compound to the TetraLogic portfolio. We
paid $13.0 million in cash at closing and entered into a contingent consideration arrangement that may require us to pay additional consideration, including milestone payments and tiered royalty payments upon commercialization. We currently estimate that the milestone payments will occur between mid-2017 and 2021. The range of undiscounted amounts that we could be required to pay under our agreement for the milestone payments is between zero and $64.5 million. The current and non-current potions of the contingent consideration liability are based upon the timing of when the Company anticipates achieving the various milestones associated with the arrangement, one of which is expected to be achieved within a year.
We have not generated revenues since our inception and we expect to continue to incur net losses for the foreseeable future. We do not currently have an open revolving line of credit or access to bank finance. We have limited assets which can be used as collateral to secure potential indebtedness. We expect our cash expenditures to increase in the near term as we fund our planned clinical trials for our product candidates. As a publicly traded company we have significant additional legal, accounting and other expenses that we were not required to incur as a private company which increases our legal and financial compliance costs and makes some activities more time
‑consuming and costly.
Our ability to fund our operations and sustain our clinical development programs is dependent on equity and equity-linked investments. None of our current investors is required to invest any additional capital in us. The recent failure of our MDS clinical trial with birinapant has seriously damaged our ability to raise new financing in the near future. Thus, there can be no assurances that we will be able to raise sufficient capital in the future from these or other similar sources or the public markets to fund our operations, and failure to do so could have a material adverse effect on our operations. In addition, the need to raise capital is expected to consume management resources, time and attention and, to a lesser extent, the time and attention of our scientific staff.
The report of our independent registered public accounting firm on our financial statements for the year ended December 31, 2015 contains explanatory language that substantial doubt exists about our ability to continue as a going concern, without raising additional capital. In addition, the report notes that the 8% Notes may become due and payable during 2016 should our common stock be delisted from the Nasdaq Global Market.
See Footnote 1 for a discussion of our Nasdaq delisting notices and their effect on our future liquidity.
Our future capital requirements will depend on many factors, including:
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the results of our pre-clinical studies and clinical trials;
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the development and commercialization of birinapant and SHAPE;
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the scope, progress, results and costs of researching and developing birinapant, SHAPE or any other future product candidates, and conducting pre-clinical studies and clinical trials;
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the timing of, and the costs involved in, obtaining regulatory approvals for birinapant, SHAPE or any other future product candidates;
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the cost of commercialization activities if birinapant, SHAPE or any other future product candidates are approved for sale, including marketing, sales and distribution costs;
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the cost of manufacturing birinapant, SHAPE or any other future product candidates in pre-clinical studies, clinical trials and, if approved, in commercial sale;
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our ability to establish and maintain strategic collaborations, licensing or other arrangements and the financial terms of such agreements;
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any product liability infringement or other lawsuits related to our products;
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the expenses needed to attract and retain skilled personnel;
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the costs associated with being a public company;
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the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims, including litigation costs and the outcome of such litigation;
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the timing, receipt and amount of sales of, or royalties on, future approved products, if any; and
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the costs associated with any future acquisitions or in-licensing of additional assets or companies to further expand our technology base.
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We cannot assure you that we will be able to obtain additional financing on terms we deem to be commercially reasonable, if at all, or that any third-party financing that we do obtain will be sufficient to cover our operating expenses, debt expenses and other payment obligations. If we fail to obtain the financing we require, we may be unable to continue our operations at the planned levels or at all. We may then have to sell our company or our assets or restructure or file for, or be forced to resort to, bankruptcy protection or liquidation.
Should we regain compliance with the Nasdaq listing requirements, successfully restructure our existing debt or otherwise satisfy our obligations to our noteholders, we believe our existing cash and investments will be sufficient to fund our current operating and investing activities through December 31, 2016. Our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement and involves risks and uncertainties, and actual results could vary as a result of a number of factors, including the factors discussed elsewhere in this quarterly report. Although we believe that we have a reasonable basis for the forward-looking statements contained in this report, we have based this estimate on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements, as defined by applicable SEC regulations.
