UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q/A
Amendment No. 1
(Mark One)
☒ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2017
OR
☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number: 001-36304
RXi Pharmaceuticals Corporation
(Exact name of registrant as specified in its charter)
Delaware | 45-3215903 | |
(State of incorporation) |
(I.R.S. Employer Identification No.) |
257 Simarano Drive, Suite 101, Marlborough, MA 01752
(Address of principal executive office) (Zip code)
Registrants telephone number: (508) 767-3861
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter time that the registrant was required to submit and post such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of large accelerated filer, accelerated filer, smaller reporting company, and emerging growth company in Rule 12b-2 of the Exchange Act.
Large accelerated filer | ☐ | Accelerated filer | ☐ | |||
Non-accelerated filer | ☐ (Do not check if a smaller reporting company) | Smaller reporting company | ☒ | |||
Emerging growth company | ☐ |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐
Indicate by checkmark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As of March 15, 2018, RXi Pharmaceuticals Corporation had 2,594,962 shares of common stock, $0.0001 par value, outstanding.
EXPLANATORY NOTE
RXi Pharmaceuticals Corporation ( we , our , us and the Company ) is filing this Amendment No. 1 on Form 10-Q/A to amend and restate in their entirety the following items of our Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, as originally filed with the Securities and Exchange Commission on May 11, 2017. (the Original Form 10-Q ):
| Part I Item 1. Financial Statements (unaudited) |
| Part I Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations |
| Part I Item 4. Controls and Procedures |
| Part II Item 6. Exhibits |
| Exhibit 31.1 Certification of Chief Executive Officer |
| Exhibit 31.2 Certification of Chief Financial Officer |
| Exhibits 101 Extensible Business Reporting Language (XBRL) |
This amendment does not modify any disclosures contained in our original Form 10-Q, except for the foregoing Items and Exhibits, and all share and per share amounts for the periods presented to give effect to the 1-for-10 reverse stock split of the Companys common stock, which was effected on January 8, 2018. This report on Form 10-Q/A is presented as of the filing date of the Original Form 10-Q and does not reflect events occurring after that date, or modify or update disclosures in any way other than as required to reflect the restatement described below. Accordingly, this Quarterly Report on Form 10-Q/A should be read in conjunction with the Original Form 10-Q, and the Companys other filings with the Securities and Exchange Commission ( SEC ) subsequent to the filing of the Original Form 10-Q, including any amendments thereto.
The purpose of this amendment is to restate our previously reported results for the quarter ended March 31, 2017 to include the accounting for the tax-related impact of the Companys acquisition of MirImmune Inc. ( MirImmune ) on January 6, 2017. Our results did not include the contemplation of deferred taxes based on the different book basis and tax basis for the acquisition of MirImmune. The acquisition resulted in an increase of $1.6 million to acquired in-process research and development expense and a corresponding $1.6 million income tax benefit resulting from the reduction in the Companys valuation allowance due to the deferred tax liability created as a result of the book and tax basis difference, which were not accounted for properly. The condensed consolidated financial statements for the quarter ended March 31, 2017 included in this Form 10-Q/A have been restated to include this adjustment to reflect the tax-related impact of the acquisition of MirImmune. This adjustment does not affect previously reported net loss or operating cash flows, although certain adjustments have been made in our condensed consolidated statement of cash flows to correspond to the income statement adjustment as described in Note 2 of the notes to our condensed consolidated financial statements included in this filing, and has no impact on the Companys balance sheet. We have made necessary conforming changes in Managements Discussion and Analysis of Financial Condition and Results of Operations resulting from the correction of this error.
RXi PHARMACEUTICALS CORPORATION
FORM 10-Q QUARTER ENDED MARCH 31, 2017
PART I FINANCIAL INFORMATION
ITEM 1. | FINANCIAL STATEMENTS |
RXi PHARMACEUTICALS CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except share and per share data)
(Unaudited)
March 31,
2017 |
December 31,
2016 |
|||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 10,205 | $ | 12,906 | ||||
Restricted cash |
50 | 50 | ||||||
Prepaid expenses |
125 | 150 | ||||||
|
|
|
|
|||||
Total current assets |
10,380 | 13,106 | ||||||
Property and equipment, net |
105 | 114 | ||||||
Notes receivable |
| 150 | ||||||
Other assets |
27 | 27 | ||||||
|
|
|
|
|||||
Total assets |
$ | 10,512 | $ | 13,397 | ||||
|
|
|
|
|||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 672 | $ | 917 | ||||
Accrued expenses |
1,593 | 1,625 | ||||||
|
|
|
|
|||||
Total current liabilities |
2,265 | 2,542 | ||||||
Commitments and contingencies |
||||||||
Stockholders equity: |
||||||||
Preferred stock, $0.0001 par value; 10,000,000 authorized |
||||||||
Series B convertible preferred stock, par value; 8,100 shares authorized; 5,737 shares issued and outstanding at December 31, 2016 |
| 3,525 | ||||||
Series C convertible preferred stock, par value; 1,800,000 shares authorized; 1,082,114 shares issued and outstanding at March 31, 2017 |
| | ||||||
Common stock, $0.0001 par value, 100,000,000 shares authorized; 2,204,548 and 1,300,318 shares issued and outstanding at March 31, 2017 and December 31, 2016, respectively |
| | ||||||
Additional paid-in capital |
79,806 | 73,429 | ||||||
Accumulated deficit |
(71,559 | ) | (66,099 | ) | ||||
|
|
|
|
|||||
Total stockholders equity |
8,247 | 10,855 | ||||||
|
|
|
|
|||||
Total liabilities and stockholders equity |
$ | 10,512 | $ | 13,397 | ||||
|
|
|
|
The accompanying notes are an integral part of these financial statements.
4
RXi PHARMACEUTICALS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands, except share and per share data)
(Unaudited)
Three Months
Ended March 31, |
||||||||
2017 | 2016 | |||||||
Net revenues |
$ | | $ | 10 | ||||
Operating expenses: |
||||||||
Research and development (1) |
1,347 | 1,305 | ||||||
Acquired in-process research and development |
4,611 | | ||||||
General and administrative (1) |
1,123 | 950 | ||||||
|
|
|
|
|||||
Total operating expenses |
7,081 | 2,255 | ||||||
|
|
|
|
|||||
Operating loss |
(7,081 | ) | (2,245 | ) | ||||
|
|
|
|
|||||
Other income: |
||||||||
Interest income, net |
| 7 | ||||||
Other income, net |
| 7 | ||||||
|
|
|
|
|||||
Total other income |
| 14 | ||||||
|
|
|
|
|||||
Loss before income taxes |
(7,081 | ) | (2,231 | ) | ||||
Income tax benefit |
1,621 | | ||||||
Net loss |
$ | (5,460 | ) | $ | (2,231 | ) | ||
|
|
|
|
|||||
Net loss per common share: |
||||||||
Basic and diluted |
$ | (2.65 | ) | $ | (3.41 | ) | ||
|
|
|
|
|||||
Weighted average common shares: basic and diluted |
2,057,114 | 653,484 | ||||||
|
|
|
|
|||||
(1) Non-cash stock-based compensation expenses included in operating expenses are as follows: |
|
|||||||
Research and development |
$ | 33 | $ | 72 | ||||
General and administrative |
81 | 222 |
The accompanying notes are an integral part of these financial statements.
5
RXi PHARMACEUTICALS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Amounts in thousands)
(Unaudited)
Three Months Ended
March 31, |
||||||||
2017 | 2016 | |||||||
Cash flows from operating activities: |
||||||||
Net loss |
$ | (5,460 | ) | $ | (2,231 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||
Depreciation and amortization |
11 | 14 | ||||||
Non-cash stock-based compensation |
114 | 294 | ||||||
Acquired in-process research and development |
4,611 | | ||||||
Deferred taxes |
(1,621 | ) | | |||||
Changes in operating assets and liabilities: |
||||||||
Prepaid expenses and other assets |
25 | 46 | ||||||
Accounts payable |
(447 | ) | (882 | ) | ||||
Accrued expenses |
(32 | ) | (166 | ) | ||||
|
|
|
|
|||||
Net cash used in operating activities |
(2,799 | ) | (2,925 | ) | ||||
Cash flows from investing activities: |
||||||||
Maturities of short-term investments |
| 2,000 | ||||||
Cash acquired in MirImmune Inc. acquisition |
100 | | ||||||
Cash paid for purchase of property and equipment |
(2 | ) | | |||||
|
|
|
|
|||||
Net cash provided by investing activities |
98 | 2,000 | ||||||
Net decrease in cash, cash equivalents and restricted cash |
(2,701 | ) | (925 | ) | ||||
Cash, cash equivalents and restricted cash at the beginning of period |
12,956 | 5,167 | ||||||
|
|
|
|
|||||
Cash, cash equivalents and restricted cash at the end of period |
$ | 10,255 | $ | 4,242 | ||||
|
|
|
|
|||||
Supplemental disclosure of non-cash investing and financing activities: |
||||||||
Conversions of Series B convertible preferred stock into common stock |
$ | 3,525 | $ | | ||||
|
|
|
|
|||||
MirImmune Inc. Acquisition: |
||||||||
Cancellation of notes receivable with the acquisition of MirImmune Inc. |
$ | 150 | $ | | ||||
|
|
|
|
|||||
Accounts payable assumed with the acquisition of MirImmune Inc. |
$ | 5 | $ | | ||||
|
|
|
|
|||||
Fair value of securities issued in connection with the acquisition of MirImmune Inc. |
$ | 2,737 | $ | | ||||
|
|
|
|
The accompanying notes are an integral part of these financial statements.
6
RXi PHARMACEUTICALS CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
1. Nature of Operations
RXi Pharmaceuticals Corporation ( RXi , we , our or the Company ) is a clinical-stage company developing innovative therapeutics based on our proprietary self-delivering RNAi (sd-rxRNA ® ) platform and Samcyprone which address significant unmet medical needs. We have a pipeline of discovery, preclinical and clinical product candidates in the areas of dermatology, ophthalmology and cell-based cancer immunotherapy. The Companys clinical development programs include RXI-109, an sd-rxRNA for the treatment of dermal and ocular scarring, and Samcyprone, a topical immunomodulator, for the treatment of warts. The Companys pipeline, coupled with our extensive patent portfolio, provides for product development and business development opportunities across a broad spectrum of therapeutic areas.
On January 3, 2018, the Board of Directors of the Company approved a 1-for-10 reverse stock split of the Companys outstanding common stock, which was effected on January 8, 2018. All share and per share amounts in the financial statements have been retroactively adjusted for all periods presented to give effect to the reverse stock split, including reclassifying an amount equal to the reduction in par value to additional paid-in capital.
2. Significant Accounting Policies
Restatement of Consolidated Financial Statements
Our condensed consolidated statement of operations and our condensed consolidated statement of cash flows for the quarter ended March 31, 2017 have been restated to include the tax-related impact of the Companys acquisition of MirImmune Inc. ( MirImmune ) on January 6, 2017. Our results did not include the contemplation of deferred taxes based on the different book basis and tax basis for the acquisition of MirImmune. The acquisition resulted in an increase to acquired in-process research and development expense and a corresponding income tax benefit resulting from the reduction in the Companys valuation allowance due to the deferred tax liability created as a result of the book and tax basis difference. This adjustment does not affect previously reported net loss or operating cash flows, although certain adjustments have been made in our condensed consolidated statement of cash flows to correspond to the income statement adjustment as noted below. The following table summarizes the effects of our restatement resulting from the correction of this error.
Three Months Ended
March 31, 2017 |
||||||||||||
Previously
Reported |
Adjustment | Restated | ||||||||||
($ in thousands, except per share data) | ||||||||||||
CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS: |
||||||||||||
Operating Expenses: |
||||||||||||
Research and development |
$ | 1,347 | $ | | $ | 1,347 | ||||||
Acquired in-process research and development |
2,990 | 1,621 | 4,611 | |||||||||
General and administrative |
1,123 | | 1,123 | |||||||||
|
|
|
|
|
|
|||||||
Total operating expenses |
5,460 | 1,621 | 7,081 | |||||||||
|
|
|
|
|
|
|||||||
Operating loss |
(5,460 | ) | (1,621 | ) | (7,081 | ) | ||||||
|
|
|
|
|
|
|||||||
Loss before income taxes |
(5,460 | ) | (1,621 | ) | (7,081 | ) | ||||||
Income tax benefit |
| 1,621 | 1,621 | |||||||||
|
|
|
|
|
|
|||||||
Net loss |
$ | (5,460 | ) | $ | | $ | (5,460 | ) | ||||
|
|
|
|
|
|
|||||||
Net loss per common share: basic and diluted |
$ | (2.65 | ) | $ | | $ | (2.65 | ) | ||||
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS: |
||||||||||||
Cash flows from operating activities: |
||||||||||||
Net loss |
$ | (5,460 | ) | $ | | $ | (5,460 | ) | ||||
Adjustments to reconcile net loss to net cash used in operating activities |
||||||||||||
Depreciation and amortization |
11 | | 11 | |||||||||
Non-cash stock-based compensation |
114 | | 114 | |||||||||
Acquired in-process research and development |
2,990 | 1,621 | 4,611 | |||||||||
Deferred tax |
| (1,621 | ) | (1,621 | ) | |||||||
Changes in operating assets and liabilities: |
||||||||||||
Prepaid expenses and other assets |
25 | | 25 | |||||||||
Accounts payable |
(447 | ) | | (447 | ) | |||||||
Accrued expenses |
(32 | ) | | (32 | ) | |||||||
|
|
|
|
|
|
|||||||
Net cash used in operating expenses |
$ | (2,799 | ) | $ | | $ | (2,799 | ) | ||||
|
|
|
|
|
|
Basis of Presentation
The accompanying condensed consolidated financial statements are unaudited and have been prepared in accordance with accounting principles generally accepted in the United States of America ( GAAP ). Certain information and footnote disclosures included in the Companys annual financial statements have been condensed or omitted. The year-end condensed balance sheet data was derived from audited financial statements, but does not include all disclosures required by GAAP. In the opinion of management, all adjustments (including normal recurring accruals) considered necessary for a fair presentation of the condensed consolidated financial statements have been included. Interim results are not necessarily indicative of results for a full year.
Uses of Estimates in Preparation of Financial Statements
The preparation of financial statements in accordance 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 financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from these estimates.
Cash, Cash Equivalents and Restricted Cash
The Company considers all highly liquid instruments with an original maturity of three months or less to be cash equivalents. Cash equivalents consist primarily of amounts invested in certificates of deposit.
Restricted cash consists of certificates of deposit held by financial institutions as collateral for the Companys corporate credit cards.
The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the balance sheet that sum to the total of the same such amounts shown in the statement of cash flows (in thousands):
March 31, | December 31, | March 31, | ||||||||||
|
|
|||||||||||
2017 | 2016 | 2016 | ||||||||||
Cash and cash equivalents |
10,205 | 12,906 | 4,192 | |||||||||
Restricted cash |
50 | 50 | 50 | |||||||||
|
|
|
|
|
|
|||||||
Cash, cash equivalents and restricted cash shown in the statement of cash flows |
10,255 | 12,956 | 4,242 | |||||||||
|
|
|
|
|
|
Research and Development Expenses
Research and development costs are charged to expense as incurred and relate to salaries, employee benefits, facility-related expenses, supplies, stock-based compensation related to employees and non-employees involved in the Companys research and development, external services, other operating costs and overhead related to our research and development departments, costs to acquire technology licenses and expenses associated with preclinical activities and our clinical trials. Payments made by the Company in advance for research and development services not yet provided and/or for materials not yet received are recorded as prepaid expenses. Accrued liabilities are recorded related to those expenses for which vendors have not yet billed us with respect to services provided and/or materials that we have received.
7
Preclinical and clinical trial expenses relate to third-party services, subject-related fees at the sites where our clinical trials are being conducted, laboratory costs, analysis costs, toxicology studies and investigator fees. Costs associated with these expenses are generally payable on the passage of time or when certain milestones are achieved. Expense is recorded during the period incurred or in the period in which a milestone is achieved. In order to ensure that we have adequately provided for preclinical and clinical expenses during the proper period, we maintain an accrual to cover these expenses. These accruals are assessed on a quarterly basis and are based on such assumptions as expected total cost, the number of subjects and clinical trial sites and length of the study. Actual results may differ from these estimates and could have a material impact on our reported results. Our historical accrual estimates have not been materially different from our actual costs.
Stock-based Compensation
The Company follows the provisions of the Financial Accounting Standards Board ( FASB ) Accounting Standards Codification ( ASC ) Topic 718, Compensation Stock Compensation ( ASC 718 ), which requires the measurement and recognition of compensation expense for all stock-based payment awards made to employees, officers and non-employee directors, including stock options. Stock compensation expense based on the grant date fair value estimated in accordance with the provisions of ASC 718 is recognized as an expense over the requisite service period.
For stock options granted as consideration for services rendered by non-employees, the Company recognizes compensation expense in accordance with the requirements of FASB ASC Topic 505-50, Equity Based Payments to Non-Employees . Non-employee option grants that do not vest immediately upon grant are recorded as an expense over the requisite service period of the underlying stock options. At the end of each financial reporting period prior to vesting, the value of these options, as calculated using the Black-Scholes option-pricing model, will be re-measured using the fair value of the Companys common stock and the non-cash compensation recognized during the period will be adjusted accordingly. Since the fair market value of options granted to non-employees is subject to change in the future, the amount of the future compensation expense will include fair value re-measurements until the stock options are fully vested.
Comprehensive Loss
The Companys comprehensive loss is equal to its net loss for all periods presented.
Net Loss per Share
The Company accounts for and discloses net loss per share in accordance with FASB ASC Topic 260, Earnings per Share. Basic and diluted net loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding. Diluted earnings per share is computed by dividing the Companys net earnings by the weighted average number of common shares outstanding and the impact of all dilutive potential common shares.
3. Recent Accounting Pronouncements
In August 2016, the FASB issued Accounting Standards Update ( ASU ) 2016-15, Statement of Cash Flows (Topic 230) Classification of Certain Cash Receipts and Cash Payments , which clarifies how certain cash receipts and payments are presented and classified in the statement of cash flows. This standard will be effective for annual reporting periods beginning after December 15, 2017, including interim periods within that reporting period. Early adoption is permitted. The amendments in ASU 2016-15 should be applied using a retrospective transition method to each period presented. The Company adopted ASU 2016-15 and the implementation of this standard had no impact on the Companys financial statements.
In November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows (Topic 230) Restricted Cash, which requires that a statement of cash flows explain the change during the period in the total of cash, cash equivalents, and amounts generally described as restricted cash and restricted cash equivalents. With this standard, amounts generally described as restricted cash or restricted cash equivalents should be included with cash and cash equivalents when reconciling the beginning of period and end of period total amounts shown on the statement of cash flows. This standard will be effective for annual reporting periods beginning after December 15, 2017, including interim periods within that reporting period. Early adoption is permitted. The Company adopted ASU 2016-18, and the guidance has been retrospectively applied to all periods presented. The total of cash, cash equivalents and restricted cash is described in Note 2. The adoption of the guidance did not have an impact on the Companys balance sheet or statement of operations.
In January 2017, the FASB issued ASU 2017-01, Business Combinations (Topic 805) Clarifying the Definition of a Business , which provides a screen to determine when an integrated set of assets and activities are not a business. The screen requires that when substantially all of the fair value of the gross assets acquired (or disposed of) is concentrated in a single identifiable asset or a group of similar identifiable assets, the set is not a business. This screen reduces the number of transactions that need to be further
8
evaluated. This standard will be effective for annual reporting periods beginning after December 15, 2017, including interim periods within that reporting period. The Company adopted ASU 2017-01 effective January 1, 2017. The implementation of this standard did not have an impact on the Companys financial statements as the acquisition of MirImmune Inc., ( MirImmune ), the Companys transaction that this ASU would have affected, did not meet the definition of a business under both the prior and the new guidance.
4. MirImmune Inc. Acquisition
On January 6, 2017, the Company entered into a Stock Purchase Agreement (the Stock Purchase Agreement ) and completed its acquisition of MirImmune. Subject to the terms of the Stock Purchase Agreement, the Companys wholly owned subsidiary formed for this purpose was merged with and into MirImmune, with MirImmune surviving as a wholly-owned subsidiary of the Company. Pursuant to the Stock Purchase Agreement, the Company acquired all of the issued and outstanding shares of capital stock of MirImmune for an aggregate of 275,036 shares of common stock of the Company and an aggregate of 1,118,224 shares of Series C Convertible Preferred Stock (the Series C Preferred Stock ). The common stock and Series C Preferred Stock were subject to a holdback of 3%, included in the shares listed above, of the aggregate closing consideration for any purchase price adjustments. Upon approval by the Companys stockholders in accordance with the stockholder approval requirements of NASDAQ Marketplace Rule 5635, each ten shares of Series C Preferred Stock share will automatically be converted into one share of the Companys common stock. The Company shall not convert any of the Series C Preferred Stock into common stock to the extent that such conversion has not been approved by the Companys stockholders in accordance with the above.
Upon the closing of the acquisition, the notes receivable outstanding on the Companys balance sheet as of December 31, 2016 were canceled.
Under the terms of the Stock Purchase Agreement, if certain development or commercial milestones are achieved within two years, the Company will be required to either (i) issue a number of shares of common stock (the Milestone Shares ) equal to the sum of 251,909 shares of common stock, plus an additional number of shares of common stock equal to 13% of the common stock issued upon exercise of any warrants issued under the Companys underwritten public offering in December 2016, but only to the extent that such warrants have been exercised prior to the milestone being achieved or (ii) pay the equivalent value of the Milestone Shares in cash. The Company may not issue any shares in satisfaction of the achievement of milestones unless it has first obtained approval of its stockholders in accordance with Rule 5635 of the NASDAQ Marketplace Rules.
The Company assessed the MirImmune acquisition under FASB ASC Topic 805, Business Combinations ( ASC 805 ). Under ASC 805, the Company determined that the acquired assets did not constitute a business and that the transaction would be accounted for as an asset acquisition. The assets and development programs acquired from MirImmune are at an early stage of development and will require a significant investment of time and capital if we are to be successful in developing them. There is no assurance that we will be successful in developing such assets, and a failure to successfully develop such assets could diminish our prospects. Under ASC 805, the assets acquired are considered to have no alternative future uses as determining the future economic benefit of the acquired assets at the date of acquisition is highly uncertain. The fair value of the assets was determined using the quoted market price of the Companys common stock on January 6, 2017.
Additionally, the Company assessed the MirImmune acquisition under ASC Topic 740, Income Taxes ( ASC 740 ). The acquisition resulted in an income tax benefit of $1,621,000 and a corresponding increase to acquired in-process research and development expense resulting from the reduction in the Companys valuation allowance due to the deferred tax liability created as a result of the book and tax basis difference.
Accordingly, during the three months ended March 31, 2017, the Company recorded $4,611,000 in in-process research and development expense related to the fair value of consideration given, which includes transaction costs, liabilities assumed and cancellation of notes receivable, and the deferred tax impact of the MirImmune acquisition.
The shares of common stock and Series C Preferred Stock subject to the holdback, as discussed above, were released and issued on April 12, 2017. The fair value of the securities held-back will be recorded as in-process research and development expense on the date of the release and issuance.
The Company assessed the Milestone Shares under ASC Topic 480, Distinguishing Liabilities from Equity ( ASC 480 ). The Company determined that liability accounting would be required for the Milestone Shares under ASC 480. The Company will record a liability related to the Milestone Shares if and when the milestones are achieved and the consideration becomes payable. At that time, the Company will record the cost of the Milestone Shares as in-process research and development expense.
5. Fair Value Measurements
The Company follows the provisions of FASB ASC Topic 820, Fair Value Measurements and Disclosures, for the Companys financial assets and liabilities that are re-measured and reported at fair value at each reporting period and are re-measured and reported at fair value at least annually using a fair value hierarchy that is broken down into three levels. Level inputs are defined as follows:
Level 1 quoted prices in active markets for identical assets or liabilities.
9
Level 2 other significant observable inputs for the assets or liabilities through corroboration with market data at the measurement date.
Level 3 significant unobservable inputs that reflect managements best estimate of what market participants would use to price the assets or liabilities at the measurement date.
The Company categorized its restricted cash as Level 2 hierarchy. The assets classified as Level 2 have initially been valued at the applicable transaction price and subsequently valued, at the end of each reporting period, using other market observable data. Observable market data points include quoted prices, interest rates, reportable trades and other industry and economic events.
The warrant issued to the Company by Thera Neuropharma, Inc. ( Thera ) is categorized as Level 3 hierarchy. The estimated fair value inputs utilizing the asset-based approach for the warrant issued to the Company by Thera include the stage of enterprise development, terms of existing contractual arrangements of the entitys equity securities, the achievement of milestones and other unobservable inputs.
Financial assets measured at fair value on a recurring basis are summarized as follows, in thousands:
Description |
At March 31, 2017 |
Quoted Prices in
Active Markets (Level 1) |
Other Significant
Observable Inputs (Level 2) |
Significant
Unobservable Inputs (Level 3) |
||||||||||||
Assets: |
||||||||||||||||
Restricted cash |
$ | 50 | $ | | $ | 50 | $ | | ||||||||
Warrant in Thera |
5 | | | 5 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
$ | 55 | $ | | $ | 50 | $ | 5 | ||||||||
|
|
|
|
|
|
|
|
Description |
At December 31, 2016 |
Quoted Prices in
Active Markets (Level 1) |
Other Significant
Observable Inputs (Level 2) |
Significant
Unobservable Inputs (Level 3) |
||||||||||||
Assets: |
||||||||||||||||
Restricted cash |
$ | 50 | $ | | $ | 50 | $ | | ||||||||
Warrant in Thera |
5 | | | 5 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
$ | 55 | $ | | $ | 50 | $ | 5 | ||||||||
|
|
|
|
|
|
|
|
A reconciliation of the beginning and ending Level 3 assets for the three months ended March 31, 2017 is as follows (in thousands):
Fair Value
Measurements Using Significant Unobservable Inputs (Level 3) |
||||
Balance, beginning of period |
$ | 5 | ||
Change in the warrant in Thera |
| |||
|
|
|||
Balance, end of period |
$ | 5 | ||
|
|
Fair Value of Financial Instruments
The carrying amounts reported in the balance sheet for cash equivalents, restricted cash, accounts payable and accrued expenses approximate their fair values due to their short-term nature.
6. Stockholders Equity
Series B Convertible Preferred Stock During the three months ended March 31, 2017, 5,737 shares of the Companys Series B Convertible Preferred Stock ( Series B Preferred Stock ) were converted into 637,445 shares of common stock of the Company.
At March 31, 2017, there was no Series B Preferred Stock issued or outstanding.
10
Series C Convertible Preferred Stock In connection with the Stock Purchase Agreement, on January 5, 2017, the Company filed a Certificate of Designation of Preferences, Rights and Limitations of Series C Convertible Preferred Stock (the Series C Convertible Preferred Stock Certificate of Designation ) with the Secretary of State of the State of Delaware. The Series C Convertible Preferred Stock Certificate of Designation provides for the issuance of up to 1,800,000 shares of Series C Preferred Stock. The Series C Preferred Stock have no voting rights, with certain exceptions as described in the Series C Convertible Preferred Stock Certificate of Designations, and shall receive dividends on an as-converted basis at the same time and in the same form as any dividends paid out on shares of the Companys common stock. Other than as set forth in the previous sentence, no other dividends shall be paid on the Series C Preferred Stock. The Company has never paid dividends on its common stock and presently has no intention of paying dividends.
Upon its issuance, the Series C Preferred Stock was assessed under ASC 480. The Company determined that the Series C Preferred Stock was not within the scope of ASC 480 and therefore, the Series C Preferred Stock was not considered a liability. The Series C Preferred Stock was recorded in permanent equity on the Companys balance sheet.
The Series C Preferred Stock was then assessed under FASB ASC 815, Derivatives and Hedging ( ASC 815 ). The Company believes that the Series C Preferred Stock is an equity host for the purposes of assessing the embedded conversion option for potential bifurcation. The Company concluded that the conversion option feature is clearly and closely related to the preferred stock host. As such, the conversion feature did not require bifurcation under ASC 815.
Refer to Note 4 for further details on the shares issued in connection with the MirImmune acquisition.
Warrants The following table summarizes the Companys outstanding warrants at March 31, 2017:
Exercise prices |
Number of Shares
Underlying Warrants |
Expiration | ||||||
$390.00 |
46 | April 27, 2017 | ||||||
$52.00 |
130,007 | June 2, 2020 | ||||||
$9.00 |
1,277,993 | December 21, 2021 | ||||||
|
|
|||||||
Total warrants outstanding |
1,408,046 | |||||||
|
|
There were no warrants exercised during the three months ended March 31, 2017 or 2016.
7. Stock-based Compensation
The Company uses the Black-Scholes option-pricing model to determine the fair value of all its option grants. For valuing options granted during the three months ended March 31, 2017 and 2016, the following assumptions were used:
For the Three Months Ended
March 31, |
||||||||
2017 | 2016 | |||||||
Risk-free interest rate |
1.96 2.49 | % | 1.18 2.02 | % | ||||
Expected volatility |
83.32 123.01 | % | 79.42 116.70 | % | ||||
Weighted average expected volatility |
84.23 | % | 88.64 | % | ||||
Expected lives (in years) |
5.20 10.00 | 5.20 10.0 | ||||||
Expected dividend yield |
0.00 | % | 0.00 | % |
The weighted average fair value of options granted during the three months ended March 31, 2017 and 2016 was $5.10 and $22.00 respectively.
The risk-free interest rate used for each grant was based upon the yield on zero-coupon U.S. Treasury securities with a term similar to the expected life of the related option. The Companys expected stock price volatility assumption is based upon the volatility of a composition of comparable companies. The expected life assumption for employee grants was based upon the simplified method provided for under ASC 718, and the expected life assumption for non-employees was based upon the contractual term of the option. The dividend yield assumption of zero is based upon the fact that the Company has never paid cash dividends and presently has no intention of paying cash dividends.
The following table summarizes the activity of Companys stock option plan for the three months ended March 31, 2017:
11
Total Number
of Shares |
Weighted-
Average Exercise Price Per Share |
Aggregate
Intrinsic Value |
||||||||||
Balance at December 31, 2016 |
37,444 | $ | 272.90 | |||||||||
Granted |
22,638 | 7.10 | ||||||||||
Exercised |
| | ||||||||||
Cancelled |
(2,004 | ) | 257.50 | |||||||||
|
|
|
|
|
|
|||||||
Balance at March 31, 2017 |
58,078 | $ | 169.80 | $ | 23,100 | |||||||
|
|
|
|
|
|
|||||||
Exercisable at March 31, 2017 |
30,805 | $ | 295.90 | $ | | |||||||
|
|
|
|
|
|
Stock-based compensation expense for the three months ended March 31, 2017 and 2016 was $114,000 and $294,000, respectively.
8. Net Loss per Share
The following table sets forth the potential common shares excluded from the calculation of net loss per common share because their inclusion would be anti-dilutive:
March 31, | ||||||||
2017 | 2016 | |||||||
Options to purchase common stock |
58,078 | 38,994 | ||||||
Common stock underlying Series C Preferred Stock |
108,211 | | ||||||
Warrants to purchase common stock |
1,408,046 | 255,697 | ||||||
|
|
|
|
|||||
Total |
1,574,335 | 294,691 | ||||||
|
|
|
|
ITEM 2. | MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
In this document, we, our, ours, us, RXi and the Company refers to RXi Pharmaceuticals Corporation and our subsidiary, MirImmune LLC and the ongoing business operations of RXi Pharmaceuticals Corporation and MirImmune LLC, whether conducted through RXi Pharmaceuticals Corporation or MirImmune LLC.
This managements discussion and analysis of financial condition as of March 31, 2017 and results of operations for the three months ended March 31, 2017 and 2016 should be read in conjunction with the financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2016 which was filed with the SEC on March 30, 2017.
This report contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as intends, believes, anticipates, indicates, plans, expects, suggests, may, should, potential, designed to, will and similar references. Such statements include, but are not limited to, statements about: our ability to successfully develop RXI-109, Samcyprone and our other product candidates (collectively our product candidates); the future success of our clinical trials with our product candidates; the timing for the commencement and completion of clinical trials; the future success of our strategic partnerships; and our ability to implement cost-saving measures. Forward-looking statements are neither historical facts nor assurances of future performance. These statements are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others: the risk that our clinical trials with our product candidates may not be successful in evaluating the safety and tolerability of these candidates or providing evidence of increased surgical scar reduction compared to placebo; the successful and timely completion of clinical trials; uncertainties regarding the regulatory process; the availability of funds and resources to pursue our research and development projects, including our clinical trials with our product candidates; general economic conditions; and those identified in our Annual Report on Form 10-K for the year ended December 31, 2016 under the heading Risk Factors and in other filings the Company periodically makes with the Securities and Exchange Commission. Forward-looking statements contained in this Quarterly Report on Form 10-Q speak as of the date hereof and the Company does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this report.
12
Overview
RXi Pharmaceuticals Corporation ( RXi , we , our or the Company ) is a clinical-stage company developing innovative therapeutics based on our proprietary self-delivering RNAi (sd-rxRNA ® ) platform and Samcyprone which address significant unmet medical needs. We have a pipeline of discovery, preclinical and clinical product candidates in the areas of dermatology, ophthalmology and cell-based cancer immunotherapy. The Companys clinical development programs include RXI-109, an sd-rxRNA for the treatment of dermal and ocular scarring, and Samcyprone, a topical immunomodulator, for the treatment of warts. The Companys pipeline, coupled with our extensive patent portfolio, provides for product development and business development opportunities across a broad spectrum of therapeutic areas.
RNAi therapies are designed to silence, or down-regulate, the expression of a specific gene that may be over-expressed in a disease condition. The Companys first RNAi clinical product candidate, RXI-109, is a self-delivering RNAi compound (sd-rxRNA) that commenced human clinical trials in 2012. RXI-109 is designed to reduce the expression of connective tissue growth factor ( CTGF ), a critical regulator of several biological pathways involved in fibrosis, including scar formation in the skin and eye. RXI-109 is currently being evaluated in a Phase 2 clinical trial, Study 1402, to prevent or reduce dermal scarring following scar revision surgery of an existing hypertrophic scar and a Phase 1/2 clinical trial, Study 1501, to evaluate the safety and clinical activity of RXI-109 to prevent the progression of retinal scarring in subjects with wet age-related macular degeneration ( AMD ).
Study 1402, the Companys Phase 2 clinical trial in hypertrophic scars, commenced in July 2014. In October 2015, we reported that preliminary data from Study 1402 demonstrated that scars at revision sites were judged to be better at three months after a treatment regimen with five mg/cm intradermal administration of RXI-109 than scars at untreated revision sites in those same subjects. Based in part on this new information, two more cohorts (Cohorts 3 and 4) were added to Study 1402 in November 2015. For these two cohorts, the number of doses was increased to either eight or nine doses of RXI-109 over a six-month period to better cover the extended wound healing/scarring profile of hypertrophic scars. Enrollment of subjects into these two new cohorts completed ahead of schedule during the third quarter of 2016.
In December 2016, the Company announced that preliminary data from the first two cohorts from Study 1402 at nine months confirmed the positive differentiation by a blinded panel of observers from untreated surgery incisions in hypertrophic scars from the previously presented data for a subset of subjects treated with five mg/cm of RXI-109 at three months. In addition, these data extend this observation to all time points, including the post-treatment follow-up period through nine months post-surgery. RXI-109 was safe and well tolerated. Additionally, as expected, the limited three-month data available from Cohort 3 appeared to align with that of the first two cohorts as these subjects all had the same dosing schedule through the third month. A complete read-out of the whole study, including all four cohorts with follow-up until nine months post-surgery, is expected in the second half of 2017.
Study 1501, the Companys Phase 1/2 clinical trial in retinal scars, commenced in November 2015, and is a multi-dose, dose escalation study conducted in subjects with AMD with evidence of subretinal fibrosis. Each subject receives four doses of RXI-109 by intraocular injection at one month intervals for a total dosing period of three months. The safety and tolerability of RXI-109, as well as the potential for clinical activity, is evaluated over the course of the study using numerous assessments to monitor the health of the retina and to assess visual acuity. The first two cohorts in Study 1501 have been completely enrolled and dosing in the third cohort at the highest planned dose level is ongoing. To date there have been no safety issues that preclude continuation of dosing. Complete enrollment is anticipated in the first half of 2017, ahead of our original plan, with complete subject participation anticipated in the second half of 2017.
Samcyprone, the Companys second clinical candidate, is a proprietary topical formulation of the small molecule diphenylcyclopropenone ( DPCP ), an immunomodulator that works by initiating a T-cell response. The use of Samcyprone allows sensitization using much lower concentrations of DPCP than are used with existing compounded DPCP solutions, avoiding hyper-sensitization to subsequent challenge doses. Samcyprone is currently being evaluated in a Phase 2a clinical trial, Study 1502, for the clearance of common warts.
Study 1502 was initiated in December 2015. Study 1502 includes a sensitization phase in which a spot on the subjects upper arm and one or more warts are treated with Samcyprone. After being sensitized in this way, the subjects enter into the treatment phase where up to four warts are treated on a once weekly basis for ten weeks with a ten-fold lower concentration of Samcyprone than in the sensitization phase. During the trial, the warts are scored, photographed and measured to monitor the level of clearance. The Company has added a second cohort and is currently enrolling subjects to explore the opportunity to reduce the sensitization dose level, which will be more convenient to physicians and subjects. With this second cohort, enrollment is expected to be completed in the second half of 2017.
In December 2016, the Company announced the results from a preliminary review of sensitization and wart clearance data from a subset of subjects that have completed the ten-week treatment phase of Study 1502. Results showed that greater than 90% of the subjects demonstrated a sensitization response, a prerequisite to be able to develop a therapeutic response. Additionally, more than
13
60% of the subjects responded to the treatment by exhibiting either complete or greater than 50% clearance of all treated warts with up to ten weekly treatments. Samcyprone treatment has been generally safe and well tolerated and has had drug-related adverse events relating to local reactions, which are typically expected for this type of treatment due to the sensitization and challenge responses in the skin. The complete readout of the final study is anticipated in the second half of 2017.
In addition to our clinical programs, we continue to advance our preclinical and discovery programs with our sd-rxRNA technology. In October 2015, we announced the selection of lead compounds targeting tyrosinase ( TYR ) and collagenase ( MMP1 ) as targets for our self-delivering platform because they are relevant for both consumer health and therapeutic development. Cosmetics are compounds that affect the appearance of the skin and make no preventative or therapeutic claims. These compounds may be developed more rapidly than therapeutics, therefore the path to market may be much shorter and less expensive. RXI-231, an sd-rxRNA compound targeting TYR, is in development as a cosmetic ingredient that may improve the appearance of uneven skin tone and pigmentation. RXI-185, an sd-rxRNA compound targeting MMP1, is in development as a cosmetic ingredient that may improve the appearance of wrinkles or skin laxity. Efficacy and toxicity testing in cell culture and skin equivalents for RXI-231 was successfully completed in December 2016. The Company is currently coordinating with a U.S. clinical testing site to initiate human testing of RXI-231 in the second quarter of 2017. RXI-231 has been manufactured in sufficient quantities to support this activity. In addition to evaluating safety, the effect of RXI-231 on the appearance of skin pigmentation will be assessed in a follow-on study.
On January 6, 2017, the Company entered into a Stock Purchase Agreement (the Stock Purchase Agreement ) by and among the Company, RXi Merger Sub, LLC, a Delaware limited liability company and wholly owned subsidiary of the Company ( RXi Merger Sub ), MirImmune Inc. ( MirImmune ), the stockholders of MirImmune set forth on the signature pages thereto (each a Seller and collectively, the Sellers ), and Alexey Wolfson, Ph.D., in his capacity as the Sellers Representative. Pursuant to the Stock Purchase Agreement, the Company acquired from the Sellers all of the issued and outstanding shares of capital stock of MirImmune for an aggregate of 275,036 shares of common stock of the Company and an aggregate of 1,118,224 shares of Series C Convertible Preferred Stock (the Series C Preferred Stock ). The common stock and Series C Preferred Stock were subject to a holdback of 3%, which was released on April 12, 2017 and included in the shares listed above, of the aggregate closing consideration for any purchase price adjustments.
In connection with and promptly following the closing of the Stock Purchase Agreement, MirImmune was merged with and into RXi Merger Sub (the Merger ), with RXi Merger Sub continuing as the surviving entity and changing its name to MirImmune, LLC. As a result of the Merger, MirImmune, LLC remains and will operate as a wholly-owned subsidiary of the Company.
The Company plans to build on the work completed by MirImmune prior to its acquisition by the Company to advance the potential of our sd-rxRNA platform for use in cell-based cancer immunotherapy. In 2017, the Company plans to release data on multiple checkpoint inhibiting sd-rxRNA compounds co-transfected in CAR T-cells in mouse models for solid tumors and share preclinical results on our use of sd-rxRNA with tumor infiltrating lymphocytes (TILs) in melanoma. Since the acquisition, the Company has initiated an internal program to evaluate the reduction of cytokines involved in cytokine release syndrome, and work on this and our other planned immunotherapy programs is currently underway.
Since inception, we have incurred significant losses. Substantially all of our losses to date have resulted from research and development expenses in connection with our clinical and research programs and from general and administrative costs. At March 31, 2017, we had an accumulated deficit of $71.6 million. We expect to continue to incur significant losses for the foreseeable future, particularly as we advance our development programs for RXI-109 and Samcyprone and expand our program in cell-based cancer immunotherapy.
On January 3, 2018, the Board of Directors of the Company approved a 1-for-10 reverse stock split of the Companys outstanding common stock, which was effected on January 8, 2018. All share and per share amounts in the financial statements have been retroactively adjusted for all periods presented to give effect to the reverse stock split, including reclassifying an amount equal to the reduction in par value to additional paid-in capital.
Critical Accounting Policies and Estimates
There have been no significant changes to our critical accounting policies since the beginning of this fiscal year. Our critical accounting policies are described in the Managements Discussion and Analysis of Financial Condition and Results of Operations section of our Annual Report on Form 10-K for the year ended December 31, 2016, which we filed with the SEC on March 30, 2017.
Results of Operations
The following data summarizes the results of our operations for the periods indicated, in thousands:
Three Months Ended
March 31, |
||||||||
2017 | 2016 | |||||||
Net revenues |
$ | | $ | 10 | ||||
Operating expenses |
(7,081 | ) | (2,255 | ) | ||||
Operating loss |
(7,081 | ) | (2,245 | ) | ||||
Income tax benefit |
1,621 | | ||||||
Net loss |
(5,460 | ) | (2,231 | ) |
14
Comparison of the Three Months Ended March 31, 2017 and 2016
Net Revenues
To date, we have primarily generated revenues through government grants. The following table summarizes our total net revenues, for the periods indicated, in thousands:
Three Months Ended
March 31, |
||||||||
2017 | 2016 | |||||||
Net revenues |
$ | | $ | 10 | ||||
|
|
|
|
There were no net revenues for the three months ended March 31, 2017. Net revenues were approximately $10,000 for the three months ended March 31, 2016 and were due to the Companys exclusive license agreement with MirImmune prior to its acquisition by the Company in January 2017.
Operating Expenses
The following table summarizes our total operating expenses, for the periods indicated, in thousands:
Three Months Ended
March 31, |
||||||||
2017 | 2016 | |||||||
Research and development |
$ | 1,347 | $ | 1,305 | ||||
Acquired in-process research and development |
4,611 | | ||||||
General and administrative |
1,123 | 950 | ||||||
|
|
|
|
|||||
Total operating expenses |
$ | 7,081 | $ | 2,255 | ||||
|
|
|
|
Research and Development Expenses
Research and development expense consists of compensation-related costs for our employees dedicated to research and development activities, fees related to our Scientific Advisory Board members, expenses related to our ongoing research and development efforts primarily related to our clinical trials, drug manufacturing, outside contract services, licensing and patent fees and laboratory supplies and services for our research programs.
Research and development expenses were $1,347,000 for the three months ended March 31, 2017, compared with $1,305,000 for the three months ended March 31, 2016. The increase of $42,000, or 3%, was due to an increase of $81,000 in research and development expenses primarily related to the commencement of work under the Companys new cell-based cancer immunotherapy programs with the acquisition of MirImmune, offset by a decrease of $39,000 in stock-based compensation expense.
Acquired In-process Research and Development Expense
In January 2017, the Company acquired all of the issued and outstanding capital stock of MirImmune, a privately-held biotechnology company that was engaged in the development of cancer immunotherapies, for shares of the Companys common stock and Series C Convertible Preferred Stock. During the three months ended March 31, 2017, the Company recorded $4,611,000 in in-process research and development expense related to the fair value of consideration given, which includes transaction costs, liabilities assumed and cancellation of notes receivable, and the deferred tax impact of the MirImmune acquisition. The Company did not have acquired in-process research and development expense for the three months ended March 31, 2016.
General and Administrative Expenses
General and administrative expense consists primarily of compensation-related costs for our employees dedicated to general and administrative activities, legal fees, audit and tax fees, consultants, professional services and general corporate expenses.
General and administrative expenses were $1,123,000 for the three months ended March 31, 2017, compared with $950,000 for the three months ended March 31, 2016. The increase of $173,000, or 18%, was due to an increase of $314,000 in general and administrative expenses due to an increase in employee headcount in connection with the acquisition of MirImmune and an increase in legal fees during the quarter, offset by a decrease of $141,000 in stock-based compensation expense.
Income Tax
The following table summarizes the Companys income tax for the periods indicated, in thousands:
Three Months Ended
March 31, |
||||||||
2017 | 2016 | |||||||
Income tax benefit |
$ | 1,621 | $ | | ||||
|
|
|
|
For the three months ended March 31, 2017, we recognized an income tax benefit of $1,621,000 for the tax-related impact of the Companys acquisition of MirImmune Inc. on January 6, 2017. There was no income tax expense or benefit during the three months ended March 31, 2016.
15
Liquidity and Capital Resources
On December 18, 2014, the Company entered into a purchase agreement (the LPC Purchase Agreement ) with Lincoln Park Capital Fund, LLC ( LPC ), pursuant to which the Company has the right to sell to LPC up to $10.8 million in shares of the Companys common stock, subject to certain limitations and conditions set forth in the LPC Purchase Agreement. Under the LPC Purchase Agreement, the Company sold a total of 7,000 shares of common stock to LPC for net proceeds of approximately $216,000. The LPC Purchase Agreement expired on April 17, 2017.
On December 21, 2016, the Company closed an underwritten public offering (the Offering ) of (i) 379,777 Class A Units, at a public offering price of $9.00 per unit, consisting of one share of the Companys common stock and a five-year warrant to purchase one share of common stock at an exercise price of $9.00 per share (the Warrants ) and (ii) 8,082 Class B Units, at a public offering price of $1,000 per unit, consisting of one share of Series B Convertible Preferred Stock (the Series B Preferred Stock ), which was convertible into 111.11 shares of common stock, and 111.11 Warrants. The Class A Units include an additional 166,667 Class A Units pursuant to the exercise by the underwriters of their over-allotment option. The total net proceeds of the Offering, including the exercise of the over-allotment option, were $10,051,000 after deducting underwriting discounts and commissions and offering expenses paid by the Company.
We had cash of $10.2 million as of March 31, 2017, compared with cash of $12.9 million as of December 31, 2016. We believe that our existing cash should be sufficient to fund our operations for at least the next twelve months. We have generated significant losses to date, have not generated any product revenue to date and may not generate product revenue in the foreseeable future, or ever. We expect to incur significant operating losses as we advance our product candidates through the drug development and regulatory process. In the future, we will be dependent on obtaining funding from third parties, such as proceeds from the issuance of debt, sale of equity, funded research and development programs and payments under partnership and collaborative research and business development agreements, in order to maintain our operations and meet our obligations to licensors. There is no guarantee that debt, additional equity or other funding will be available to us on acceptable terms, or at all. If we fail to obtain additional funding when needed, we would be forced to scale back or terminate our operations or to seek to merge with or to be acquired by another company.
The following table summarizes our cash flows for the periods indicated, in thousands:
Three Months Ended
March 31, |
||||||||
2017 | 2016 | |||||||
Net cash used in operating activities |
$ | (2,799 | ) | $ | (2,925 | ) | ||
Net cash provided by investing activities |
98 | 2,000 | ||||||
Net cash used in financing activities |
| | ||||||
|
|
|
|
|||||
Net decrease in cash, cash equivalents and restricted cash |
$ | (2,701 | ) | $ | (925 | ) |
Net Cash Flow from Operating Activities
Net cash used in operating activities was $2,799,000 for the three months ended March 31, 2017 compared with $2,925,000 for the three months ended March 31, 2016. The decrease in cash used in operating activities was primarily due to an increase in net loss of $3,229,000 offset by changes in non-cash expenses of $2,807,000 primarily driven by acquired in-process research and development expense related to the fair value of consideration given and the tax-related impact resulting from the acquisition of MirImmune in January 2017.
Net Cash Flow from Investing Activities
Net cash provided by investing activities was $98,000 for the three months ended March 31, 2017 compared with $2,000,000 for the three months ended March 31, 2016. The decrease in the net cash flow from investing activities was primarily related to maturities of short-term investments.
Net Cash Flow from Financing Activities
There were no cash flows related to financing activities for the three months ended March 31, 2017 or 2016.
16
Off-Balance Sheet Arrangements
In connection with certain license agreements, we are required to indemnify the licensor for certain damages arising in connection with the intellectual property rights licensed under the agreement. In addition, we are a party to a number of agreements entered into in the ordinary course of business that contain typical provisions that obligate us to indemnify the other parties to such agreements upon the occurrence of certain events. These indemnification obligations are considered off-balance sheet arrangements in accordance with ASC Topic 460, Guarantor s Accounting and Disclosure Requirements for Guarantees, Including Indirect Guarantees of Indebtedness of Others . To date, we have not encountered material costs as a result of such obligations and have not accrued any liabilities related to such obligations in our financial statements. See Note 8 to our financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2016, which was filed with the SEC on March 30, 2017, for further discussion of these indemnification agreements.
ITEM 3. | QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
Not applicable.
ITEM 4. | CONTROLS AND PROCEDURES |
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and acting Chief Financial Officer, evaluated the effectiveness of disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of March 31, 2017, the end of the period covered by our Original Form 10-Q. Based on that evaluation, our Chief Executive Officer and acting Chief Financial Officer concluded that our disclosure controls and procedures were effective to ensure that information that we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms.
Subsequently, in connection with the preparation of our Annual Report on Form 10-K, our management, with the participation of our Chief Executive Officer and acting Chief Financial Officer, reassessed the effectiveness of the Companys internal control over financial reporting. In connection with this assessment, we identified a material weakness, as described below, in our internal control over financial reporting as of March 31, 2017. A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the annual or interim financial statements will not be prevented or detected on a timely basis. Because of the material weakness, identified below, management concluded that, as of March 31, 2017, our disclosure controls and procedures were not effective.
Inadequate and ineffective controls over accounting for income taxes
We did not have adequate design or operation of controls that provide reasonable assurance on a timely basis that the accounting for income taxes, including the related financial statement disclosures, were in accordance with U.S. generally accepted accounting principles. On an annual basis, we engage and rely upon third-party tax accountants to provide technical expertise with respect to complex tax accounting matters to assist us in maintaining adequate controls that provide reasonable assurance as to the complete and accurate recording and disclosure of deferred taxes due to differences in accounting treatment for book and tax purposes and other tax-related matters in our financial statements.
Our previously reported results prior to this amendment did not include the contemplation of deferred taxes based on the different book basis and tax basis for the acquisition of MirImmune. The acquisition resulted in an increase of $1.6 million to acquired in-process research and development expense and a corresponding $1.6 million income tax benefit resulting from the reduction in the Companys valuation allowance due to the deferred tax liability created as a result of the book and tax basis difference, which were not accounted for properly. Our condensed consolidated financial statements for the quarter ended March 31, 2017 included in this Form 10-Q/A have been restated to include this adjustment to reflect the tax-related impact of the acquisition of MirImmune. This adjustment did not affect previously reported net loss or operating cash flows and had no impact on the Companys balance sheet.
Remediation Plans
Management is committed to remediating the material weakness in a timely fashion. We have begun the process of executing remediation plans that address the material weakness in internal control over financial reporting relating to accounting for income taxes. Managements planned actions to address the material weakness include:
| Increased involvement on a quarterly basis of our third-party tax accountants dedicated to determining the appropriate accounting for material and complex tax transactions in a timely manner; |
| Review of tax accounting process to identify and implement enhanced tax accounting processes and related internal control procedures; and |
| Establishing additional training and education programs for financial personnel responsible for income tax accounting. |
Under the direction of the Audit Committee, management will continue to review and make necessary changes to the overall design of the Companys internal control environment, as well as policies and procedures to improve the overall effectiveness of internal control over financial reporting.
Management believes the measures described above that will be implemented will remediate the control deficiencies identified and will strengthen our internal control over financial reporting. We continuously seek to improve and strengthen our control processes to ensure that all of our controls and procedures are adequate and effective. As management continues to evaluate and work to improve internal control over financial reporting, we may take additional measures to address control deficiencies or determine to modify, or in appropriate circumstances not to complete, certain of the remediation measures described above.
Changes in Internal Control over Financial Reporting
There has not been any change in our internal control over financial reporting that occurred during the quarterly period ended March 31, 2017 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
ITEM 1. | LEGAL PROCEEDINGS |
None.
ITEM 1A. | RISK FACTORS |
You should consider the Risk Factors included under Item 1A. of our Annual Report on Form 10-K for the year ended December 31, 2016 filed with the SEC on March 30, 2017.
ITEM 2. | UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS |
None.
ITEM 3. | DEFAULTS UPON SENIOR SECURITIES |
None.
ITEM 4. | MINE SAFETY DISCLOSURES |
Not applicable.
17
ITEM 5. | OTHER INFORMATION |
None.
ITEM 6. | EXHIBITS |
EXHIBIT INDEX
Incorporated by Reference Herein |
||||||
Exhibit
|
Description |
Form |
Date |
|||
31.1 | Sarbanes-Oxley Act Section 302 Certification of Chief Executive Officer and Chief Financial Officer.* | |||||
32.1 | Sarbanes-Oxley Act Section 906 Certification of Chief Executive Officer and Chief Financial Officer.* | |||||
101 | The following financial information from the Quarterly Report on Form 10-Q of RXi Pharmaceuticals Corporation for the quarter ended March 31, 2017, formatted in XBRL (eXtensible Business Reporting Language): (1) Condensed Consolidated Balance Sheets as of March 31, 2017 and December 31, 2016; (2) Condensed Consolidated Statements of Operations for the Three Months Ended March 31, 2017 and 2016; (3) Condensed Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2017 and 2016; and (4) Notes to Condensed Consolidated Financial Statements (Unaudited).* |
* | Filed herewith. |
18
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
RXi Pharmaceuticals Corporation | ||
By: |
/s/ Geert Cauwenbergh |
|
Geert Cauwenbergh, Dr. Med. Sc. | ||
President, Chief Executive Officer and acting Chief Financial Officer | ||
Date: March 26, 2018 |
19
Exhibit 31.1
CERTIFICATION OF CHIEF EXECUTIVE OFFICER AND CHIEF FINANCIAL OFFICER
PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Geert Cauwenbergh, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q/A of RXi Pharmaceuticals Corporation;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. I am responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have:
a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c) Evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this report my conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) Disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and
5. I have disclosed, based on my most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of registrants board of directors (or persons performing the equivalent functions):
a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrants ability to record, process, summarize and report financial information; and
b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal controls over financial reporting.
Dated: March 26, 2018
/s/ Geert Cauwenbergh |
Geert Cauwenbergh, Dr. Med. Sc. |
President, Chief Executive Officer and acting Chief
Financial Officer |
(as Principal Executive and Financial Officer) |
Exhibit 32.1
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of RXi Pharmaceuticals Corporation (the Company) on Form 10-Q/A for the period ended March 31, 2017 as filed with the Securities and Exchange Commission on the date hereof (the Report), the undersigned officer of the Company certifies, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that to his knowledge:
1. The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
2. The information contained in the Report fairly presents, in all material respects, the Companys financial condition and result of operations.
/s/ Geert Cauwenbergh |
Geert Cauwenbergh, Dr. Med. Sc. |
President, Chief Executive Officer and acting Chief Financial Officer |
(as Principal Executive and Financial Officer) |
March 26, 2018 |