Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM10-Q/A

Amendment No. 1FORM 10-Q

 

 

(Mark One)

xQUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 20172018

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)

Registrant’s 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  x    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 ofRegulation 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  x    No  ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, anon-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 Rule12b-2 of the Exchange Act.

 

Large accelerated filer  Accelerated filer 
Non-accelerated filer ☐  (Do not check if a smaller reporting company) Smaller reporting company x
 
 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 inRule 12b-2 of the Exchange Act).    Yes  ¨    No  x

As of March 15,August 10, 2018, RXi Pharmaceuticals Corporation had 2,594,9624,376,322 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 June 30, 2017, as originally filed with the Securities and Exchange Commission on August 10, 2017. (the “Original Form 10-Q”):

 

Part I – Item 1. Financial Statements (unaudited)

 

Part I – Item 2. Management’s 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 Company’s 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 Company’s 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 June 30, 2017 to include the accounting for the tax-related impact of the Company’s 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 Company’s 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 June 30, 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 Company’s balance sheet. We have made necessary conforming changes in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” resulting from the correction of this error.


RXi PHARMACEUTICALS CORPORATION

FORM10-Q — QUARTER ENDED JUNE 30, 20172018

INDEX

 

Part No.

 Item No. Description Page
No.
 
  

Part No.

  Item No.  

Description

  Page
No.
 
I    FINANCIAL INFORMATION     FINANCIAL INFORMATION  
  
  1  Financial Statements (Unaudited)   4  1   Financial Statements (Unaudited) 3 
    Condensed Consolidated Balance Sheets as of June 30, 2017 and December 31, 2016   4    Condensed Consolidated Balance Sheets as of June 30, 2018 and December 31, 2017 3 
    Condensed Consolidated Statements of Operations for the Three and Six Months Ended June 30, 2017 and 2016   5    Condensed Consolidated Statements of Operations for the Three and Six Months Ended June 30, 2018 and 2017 4 
    Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2017 and 2016   6    Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2018 and 2017 5 
    Notes to Condensed Consolidated Financial Statements   7    Notes to Condensed Consolidated Financial Statements 6 
  2  Management’s Discussion and Analysis of Financial Condition and Results of Operations   13  2   Management’s Discussion and Analysis of Financial Condition and Results of Operations 12 
  3  Quantitative and Qualitative Disclosures about Market Risk   18  3   Quantitative and Qualitative Disclosures about Market Risk 18 
  4  Controls and Procedures   18  4   Controls and Procedures 18 
  
II    OTHER INFORMATION   19    OTHER INFORMATION 19 
  
  1  Legal Proceedings   19  1   Legal Proceedings 19 
  1A  Risk Factors   19  1A Risk Factors 19 
  2  Unregistered Sales of Equity Securities and Use of Proceeds   20  2   Unregistered Sales of Equity Securities and Use of Proceeds 19 
  3  Defaults Upon Senior Securities   20  3   Defaults Upon Senior Securities 19 
  4  Mine Safety Disclosures   20  4   Mine Safety Disclosures 19 
  5  Other Information   20  5   Other Information 19 
  6  Exhibits   20  6   Exhibits 20 
 
 
SignaturesSignatures     21 Signatures 21 


PART I — FINANCIAL INFORMATION

 

ITEM 1.
ITEM 1.FINANCIAL STATEMENTS

RXi PHARMACEUTICALS CORPORATION

CONDENSED CONSOLIDATED BALANCE SHEETS

(Amounts in thousands, except share and per share data)

(Unaudited)

 

  June 30,
2017
 December 31,
2016
  

June 30,

2018

  December 31,
2017
 

ASSETS

           

Current assets:

           

Cash and cash equivalents

  $7,702  $12,906  $5,315  $3,581 

Restricted cash

   50  50   50   50 

Prepaid expenses

   337  150 
  

 

  

 

 
Prepaid expenses and other current assets  459   201 

Total current assets

   8,089  13,106   5,824   3,832 

Property and equipment, net

   275  114   207   248 

Notes receivable

   —    150 

Other assets

   27  27      18 
  

 

  

 

 

Total assets

  $8,391  $13,397  $6,031  $4,098 
  

 

  

 

         

LIABILITIES AND STOCKHOLDERS’ EQUITY

           

Current liabilities:

           

Accounts payable

  $741  $917  $542  $511 

Accrued expenses

   1,713  1,625   2,217   1,754 
  

 

  

 

 

Total current liabilities

   2,454  2,542   2,759   2,265 

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; no shares issued or outstanding

   —     —   

Common stock, $0.0001 par value, 100,000,000 shares authorized; 2,324,621 and 1,300,318 shares issued and outstanding at June 30, 2017 and December 31, 2016, respectively

   —     —   
Preferred stock, $0.0001 par value, 10,000,000 shares authorized; no shares issued or outstanding      
Common stock, $0.0001 par value, 100,000,000 shares authorized; 4,360,566 and 2,429,993 shares issued and outstanding at June 30, 2018 and December 31, 2017, respectively      

Additionalpaid-in capital

   80,010  73,429   85,963   80,384 

Accumulated deficit

   (74,073 (66,099  (82,691)  (78,551)
  

 

  

 

 

Total stockholders’ equity

   5,937  10,855   3,272   1,833 
  

 

  

 

 

Total liabilities and stockholders’ equity

  $8,391  $13,397  $6,031  $4,098 
  

 

  

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

3

RXi PHARMACEUTICALS CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Amounts in thousands, except share and per share data)

(Unaudited)

 

   Three Months Ended
June 30,
  Six Months Ended
June 30,
 
   2017  2016  2017  2016 

Net revenues

  $—    $9  $—    $19 

Operating expenses:

     

Research and development

   1,329   1,339   2,676   2,644 

Acquiredin-process research and development

   85   —     4,696   —   

General and administrative

   1,100   885   2,223   1,835 
  

 

 

  

 

 

  

 

 

  

 

 

 

Total operating expenses

   2,514   2,224   9,595   4,479 
  

 

 

  

 

 

  

 

 

  

 

 

 

Operating loss

   (2,514  (2,215  (9,595  (4,460
  

 

 

  

 

 

  

 

 

  

 

 

 

Other income (expense):

     

Interest income, net

   —     4   —     11 

Other income (expense), net

   —     (1  —     6 
  

 

 

  

 

 

  

 

 

  

 

 

 

Total other income

   —     3   —     17 
  

 

 

  

 

 

  

 

 

  

 

 

 

Loss before income taxes

   (2,514  (2,212  (9,595  (4,443

Income tax benefit

   —     —     1,621   —   

Net loss

  $(2,514 $(2,212 $(7,974 $(4,443
  

 

 

  

 

 

  

 

 

  

 

 

 

Net loss per common share:

     

Basic and diluted

  $(1.12 $(3.38 $(3.71 $(6.80
  

 

 

  

 

 

  

 

 

  

 

 

 

Weighted average common shares: basic and diluted

   2,238,836   653,484   2,148,477   653,484 
  

 

 

  

 

 

  

 

 

  

 

 

 

  Three Months Ended
June 30,
  Six Months Ended
June 30,
 
  2018  2017  2018  2017 
Revenues $58  $  $81  $ 
Operating expenses:                
Research and development  1,183   1,329   2,544   2,676 
Acquired in-process research and development     85      4,696 
General and administrative  774   1,100   1,675   2,223 
Total operating expenses  1,957   2,514   4,219   9,595 
Operating loss  (1,899)  (2,514)  (4,138)  (9,595)
Total other expense, net  (2)     (2)   
Loss before income taxes  (1,901)  (2,514)  (4,140)  (9,595)
Income tax benefit           1,621 
Net loss $(1,901) $(2,514) $(4,140) $(7,974)
Net loss per share:                
Basic and diluted $(0.46) $(1.12) $(1.25) $(3.71)
Weighted average shares: basic and diluted  4,102,423   2,238,836   3,302,885   2,148,477 
                 

The accompanying notes are an integral part of these condensed consolidated financial statements.

4

RXi PHARMACEUTICALS CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Amounts in thousands)


(Unaudited)

 

  Six Months Ended
June 30,
  

Six Months Ended

June 30,

 
  2017 2016   2018   2017 

Cash flows from operating activities:

           

Net loss

  $(7,974 $(4,443 $(4,140) $(7,974)

Adjustments to reconcile net loss to net cash used in operating activities:

           

Depreciation and amortization

   27  28   41   27 

Non-cash stock-based compensation

   233  521   78   233 

Acquiredin-process research and development

   4,696   —        4,696 

Deferred taxes

   (1,621  —        (1,621)

Value ofnon-marketable equity securities recognized as revenue

   —    (9

Changes in operating assets and liabilities:

           

Prepaid expenses and other assets

   (187 (166  (240)  (187)

Accounts payable

   (378 (866  31   (378)

Accrued expenses

   88  150   463   88 
  

 

  

 

 

Net cash used in operating activities

   (5,116 (4,785  (3,767)  (5,116)

Cash flows from investing activities:

           

Purchase of short-term investments

   —    (2,000

Maturities of short-term investments

   —    5,500 

Cash acquired in MirImmune Inc. acquisition

   100   —        100 

Cash paid for purchase of property and equipment

   (188  —        (188)
  

 

  

 

 

Net cash (used in) provided by investing activities

   (88 3,500 

Net decrease in cash, cash equivalents and restricted cash

   (5,204 (1,285
Net cash used in investing activities     (88)
Cash flows from financing activities:        
Net proceeds from the issuance of common stock and warrants  5,501    
Net cash provided by financing activities  5,501    
Net increase (decrease) in cash, cash equivalents and restricted cash  1,734   (5,204)

Cash, cash equivalents and restricted cash at the beginning of period

   12,956  5,167   3,631   12,956 
  

 

  

 

 

Cash, cash equivalents and restricted cash at the end of period

  $7,752  $3,882  $5,365  $7,752 
  

 

  

 

 

Supplemental disclosure ofnon-cash investing and financing activities:

           

Conversions of Series B convertible preferred stock into common stock

  $3,525  $—    $  $3,525 
  

 

  

 

 
Conversion of Series C convertible preferred stock into common stock $  $816 

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.

  $2,824  $—   
  

 

  

 

 

Conversion of Series C convertible preferred stock into common stock

  $816  $—   
  

 

  

 

 
Cancellation of notes receivable $  $150 
Accounts payable assumed $  $5 
Fair value of securities issued $  $2,824 

The accompanying notes are an integral part of these condensed consolidated financial statements.


5

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-stagebiotechnology company developing innovativethe next generation of immuno-oncology therapeutics based on our proprietaryits self-delivering RNAi( (“sd-rxRNA®) platformtherapeutic platform. The Company’s sd-rxRNA compounds do not require a delivery vehicle to penetrate the cell and Samcyprone™ which address significant unmet medical needs.are designed to “silence,” or down-regulate, the expression of a specific gene that may be over-expressed in a disease condition. We havebelieve that this provides RXi with a pipelinedistinct advantage in adoptive cell transfer therapy, the Company’s initial focus and approach to immuno-oncology.

Prior to RXi’s acquisition of discovery,MirImmune Inc. in January 2017, the Company’s principal activities consisted of the preclinical and clinical product candidatesdevelopment of the Company’s sd-rxRNA compounds and topical immunotherapy agent in the areas of dermatology ophthalmology and cell-based cancer immunotherapy.ophthalmology. In January 2018, after a thorough review of its business operations, development programs and financial resources, the Company made a strategic decision to focus solely on immuno-oncology to accelerate growth and support a potential return on investment for its stockholders. The Company’s clinicalbusiness strategy focuses on the development programs includeRXI-109, anof immuno-oncology therapeutics utilizing our proprietary sd-rxRNA technology. The Company intends to seek a partner and/or out-licensee for the treatmenteach of dermalits dermatology and ocular scarring,ophthalmology franchises, including RXI-109 and Samcyprone™, a topical immunomodulator, forto continue their development. The goal of any such transaction would be to allow the treatment of warts. The Company’s pipeline, coupled withCompany to monetize these preclinical and clinical assets to further fund ongoing and future development work in our extensive patent portfolio, provides for product developmentimmuno-oncology programs and business development opportunities across a broad spectrum of therapeutic areas.extend our financial runway.

On January 3, 2018, the Board of Directors of the Company approved a 1-for-10 reverse stock split of the Company’s 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. Liquidity and Going Concern

The Company has limited cash resources and has expended substantial funds on the research and development of the Company’s product candidates and funding general operations. As a result, the Company has reported recurring losses from operations since inception and expects that the Company will continue to have negative cash flows from its operations for the foreseeable future. Historically, the Company’s primary source of financing has been the sale of its securities. The Company’s ability to continue to fund its operations is dependent on the amount of cash on hand and its ability to raise additional capital through, but not limited to, equity or debt offerings or strategic opportunities. This is dependent on a number of factors, including the market demand or liquidity of the Company’s common stock. There can be no assurance that the Company will be successful in accomplishing these plans.

The funds available under the Company’s purchase agreement with Lincoln Park Capital Fund, LLC (“LPC”) should provide the Company with sufficient cash to fund operations for at least the next twelve months. However, certain ownership limitations under the terms of the purchase agreement preclude the Company from relying on the full available funds for going concern purposes. As a result, the Company has concluded that there is substantial doubt regarding its ability to continue as a going concern for at least the next twelve months. If the Company fails to obtain additional funding when needed, the Company would be forced to scale back or terminate its operations or to seek to merge with or to be acquired by another company. These financial statements do not include any adjustments to, or classification of, recorded asset amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.

6

3. 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 June 30, 2017 have been restated to include the tax-related impact of the Company’s 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 Company’s 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 restatement did not impact our condensed consolidated statement of operations for the three months ended June 30, 2017. The following table summarizes the effects of our restatement on the six months ended June 30, 2017 resulting from the correction of this error.

   Six Months Ended
June 30, 2017
 
   Previously
Reported
   Adjustment   Restated 
   ($ in thousands, except per share data) 

CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS:

      

Operating Expenses:

      

Research and development

  $2,676   $—     $2,676 

Acquired in-process research and development

   3,075    1,621    4,696 

General and administrative

   2,223    —      2,223 
  

 

 

   

 

 

   

 

 

 

Total operating expenses

   7,974    1,621    9,595 
  

 

 

   

 

 

   

 

 

 

Operating loss

   (7,974   (1,621   (9,595
  

 

 

   

 

 

   

 

 

 

Loss before income taxes

   (7,974   (1,621   (9,595

Income tax benefit

   —      1,621    1,621 
  

 

 

   

 

 

   

 

 

 

Net loss

  $(7,974)  $—     $(7,974
  

 

 

   

 

 

   

 

 

 

Net loss per common share: basic and diluted

  $(3.71  $—     $(3.71

CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS:

      

Cash flows from operating activities:

      

Net loss

  $(7,974  $—     $(7,974

Adjustments to reconcile net loss to net cash used in operating activities

      

Depreciation and amortization

   27    —      27 

Non-cash stock-based compensation

   233    —      233 

Acquired in-process research and development

   3,075    1,621    4,696 

Deferred tax

   —      (1,621   (1,621

Changes in operating assets and liabilities:

      

Prepaid expenses and other assets

   (187   —      (187

Accounts payable

   (378   —      (378

Accrued expenses

   88    —      88 
  

 

 

   

 

 

   

 

 

 

Net cash used in operating expenses

  $(5,116  $—     $(5,116
  

 

 

   

 

 

   

 

 

 

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 Company’s annual financial statements have been condensed or omitted. Theyear-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.

Principles of Consolidation

The consolidated financial statements include the accounts of RXi Pharmaceuticals Corporation and its wholly-owned subsidiary, MirImmune, LLC. All material intercompany accounts have been eliminated in consolidation.

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 materially 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 Company’s corporate credit cards.

Fair Value of Financial Instruments

The following table provides a reconciliation of cash, cash equivalents, and restricted cashcarrying amounts reported withinin the balance sheet that sumfor cash equivalents, restricted cash, accounts payable and accrued expenses approximate their fair values due to the total of the same such amounts shown in the statement of cash flows (in thousands):their short-term nature.

 

   June 30,   December 31,   June 30, 
   2017   2016   2016 

Cash and cash equivalents

   7,702    12,906    3,832 

Restricted cash

   50    50    50 
  

 

 

   

 

 

   

 

 

 

Cash, cash equivalents and restricted cash shown in the statement of cash flows

   7,752    12,956    3,882 
  

 

 

   

 

 

   

 

 

 

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 andnon-employees involved in the Company’s research and development, external services, other operating costs and overhead related to ourits research and development departments, costs to acquire technology licenses and expenses associated with preclinical activities and ourits clinical trials. Research and development expenses are charged to expense as incurred. 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.expenses and expensed when the service has been performed or when the goods have been received. Accrued liabilities are recorded related to those expenses for which vendors have not yet billed usthe Company with respect to services provided and/or materials that we haveit has received.

7

Preclinical and clinical trial expenses relate to estimates of costs incurred and fees connected with clinical trial sites, third-party services,clinical research organizations and other preclinical and clinical related activities and include such items as subject-related fees, at the sites where our clinical trials are being conducted, laboratory costs,work, investigator fees and analysis costs, toxicology studies and investigator fees.costs. 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 havethe Company has adequately provided for preclinical and clinical expenses during the proper period, we maintainthe Company maintains 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.study, timing of certain milestones and other information available to us. Actual results may differ from these estimates and could have a material impact on ourthe Company’s reported results. OurThe Company’s historical accrual estimates have not been materially different from ourits 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, non-employee directors, andnon-employee directors, non-employees, 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

Income Taxes

non-employees, theThe Company recognizes compensation expenseassets or liabilities for the deferred tax consequences of temporary differences between the tax basis of assets or liabilities and their reported amounts in the financial statements in accordance with the requirements of FASB ASC Topic505-50, 740, Equity Based Payments toNon-EmployeesAccounting for Income Taxes”..”Non-employee option grants that do not vest immediately upon grant are recorded as an expense over On December 22, 2017, the requisite service periodPresident of the underlying stock options. AtUnited States signed into law the end of each financial reporting period priorTax Cuts and Jobs Act tax reform legislation. This legislation makes significant changes in U.S. tax law including a reduction in the corporate tax rates, changes to vesting, the value of these options, as calculated using the Black-Scholes option-pricing model, will bere-measured using the fair valuenet operating loss carryforwards and carrybacks, and a repeal of the corporate alternative minimum tax. There has been no impact to the Company’s common stock and thenon-cash compensation recognized during the period will be adjusted accordingly. Since the fair market value of options granted tonon-employees is subject to change in the future, the amountincome tax expense as a result of the future compensation expense will include fair valuere-measurements untilTax Cuts and Jobs Act. The Company is still assessing the stock options are fully vested.impact of the Tax Cuts and Jobs Act and does not expect the other provisions to have a material impact on the Company’s financial statements.

Comprehensive Loss

The Company’s 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 the FASB ASC Topic 260, “Earnings per Share.”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 Company’s net earnings by the weighted average number of common shares outstanding and the impact of all dilutive potential common shares.

3.4. Recent Accounting Pronouncements

In August 2016,May 2014, the FASB issued Accounting Standards Update (“ASU”)2016-15, 2014-09, “StatementRevenue from Contracts with Customers (Topic 606)”. ASU 2014-09 states that an entity should recognize revenue to depict the transfer of Cash Flowspromised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. On July 9, 2015, the FASB voted to delay the effective date of the new revenue standard by one year but to permit entities to choose to adopt the standard as of the original effective date. In March 2016, the FASB issued ASU 2016-08, “Revenue from Contracts with Customers (Topic 230)606)ClassificationPrincipal Versus Agent Considerations,” which improves the operability and understandability of Certain Cash Receiptsthe implementation guidance on principal versus agent considerations. In April 2016, the FASB issued ASU 2016-10, “Revenue from Contracts with Customers (Topic 606) – Identifying Performance Obligations and Cash PaymentsLicensing,” which clarifies how certain cash receiptstwo aspects of the guidance on accounting for revenue contracts with customers: identifying performance obligations and payments are presentedthe licensing implementation guidance. In May 2016, the FASB issued ASU 2016-12, “Revenue from Contracts with Customers (Topic 606) – Narrow Scope Improvements and classifiedPractical Expedients,” which addresses collectability assessment, presentation of sales taxes, noncash consideration and completed contracts and contract modifications at transition. The amendments in these ASUs do not change the statement of cash flows.core principles for those areas. This standard will bebecame effective for annual reporting periods beginning after December 15, 2017, including interim periods within that reporting period. Early adoption is not permitted. The amendments in ASU2016-15 should be applied using a retrospective transition method to each period presented. The Company adopted this ASU2016-15 in the first quarter of 2017 and2018. Since the implementation ofCompany has no significant revenue, this standardASU had no immediate impact on the Company’sits consolidated financial statements.

8

In NovemberFebruary 2016, the FASB issued ASU2016-18, 2016-02, “Statement of Cash FlowsLeases (Topic 230) – Restricted Cash,842),which requires companies that are lessees to recognize right-of-use asset and lease liability for most leases that do not meet the definition of a short-term lease. For income statement of cash flows explain the change during the periodpurposes, leases will continue to be classified as either operating or financing. Classification will be based on criteria that are largely similar to those applied in the total of cash, cash equivalents,current lease accounting. This standard will result in extensive qualitative 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.quantitative disclosure changes. This standard will be effective for annual reporting periods beginning after December 15, 2017,2018, including interim periods within that reporting period. Early adoption is permitted. The Company adoptedis currently evaluating the impact of this ASU2016-18 in the first quarter of 2017, 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 Company’s balance sheet or statement of operations.its consolidated financial statements.

In January 2017,June 2018, the FASB issued ASU2017-01, 2018-07,Business CombinationsCompensation – Stock Compensation (Topic 805)718)Clarifying the Definition of a BusinessImprovements to Nonemployee Share-Based Payment Accounting,” which providesexpands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from non-employees. The amendment specifies that Topic 718 applies to all share-based payment transactions in which a screengrantor acquires goods or services 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 concentratedbe used or consumed 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 evaluated.grantor’s own operations by issuing share-based payment awards. This standard will be effective for annual reporting periods beginning after December 15, 2017, including interim periods within that reporting period. The Company adopted ASU2017-01 effective January 1, 2017. The implementation of this standard did not have an impact on the Company’s financial statements as the acquisition of MirImmune Inc., (“MirImmune”), the Company’s transaction that this ASU would have affected, did not meet the definition of a business under both the prior and the new guidance.

In May 2017, the FASB issued ASU2017-09,Compensation – Stock Compensation (Topic 718) – Scope of Modification Accounting,” which provides guidance about which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting. This standard will be effective for annual reporting periods beginning after December 15, 2017,2018, including interim periods within that reporting period. Early adoption is permitted.permitted, but no earlier than an entity’s adoption date of Topic 606. The Company early adopted this ASU2017-09 in the second quarter ended June 30, 2017 and the implementation of this standard2018. The ASU had no material impact on the Company’s consolidated financial statements.

4. MirImmune Inc. Acquisition

5. Stockholders’ Equity

Lincoln Park Capital Fund, LLC –On January 6,August 8, 2017, the Company entered into a Stock Purchase Agreementpurchase agreement (the “StockLPC Purchase Agreement”) and completed its acquisition of MirImmune. Subjecta registration rights agreement with LPC, pursuant to the terms of the Stock Purchase Agreement, the Company’s 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,which the Company acquired all ofhas the issued and outstandingright to sell to LPC 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 Convertible Preferred Stock”). The shares of common stock and Series C Convertible Preferred Stock were subject to a holdback of 3% of the aggregate closing consideration for any purchase price adjustments. The shares subject to the holdback were released and issued on April 12, 2017.

Upon the closing of the acquisition, the notes receivable outstanding on the Company’s balance sheet as of December 31, 2016 were cancelled.

The Company assessed the acquisition of MirImmune 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 Company’s common stock, on January 6, 2017, the date of the acquisition,subject to certain limitations and fully expensed asin-process research and development.

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 reductionconditions set forth in the Company’s valuation allowance due to the deferred tax liability created as a result of the book and tax basis difference.LPC Purchase Agreement.

During the three months ended June 30, 2017,2018, the Company recorded $85,000 in in-process research and development expense relatedsold 150,000 shares of common stock to the fair valueLPC for net proceeds of consideration for the holdback shares released.approximately $359,000. During the six months ended June 30, 2017,2018, the Company recorded $4,696,000 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 was restricted from converting any of the Series C Convertible Preferred Stock into common stock to the extent that such conversion was not approved by the Company’s stockholders in accordance with the stockholder approval requirements of NASDAQ Marketplace Rule 5635. On June 9, 2017, with the approval of the Company’s stockholders in accordance with the NASDAQ stockholder approval requirements, every ten shares of the Series C Convertible Preferred Stock outstanding were automatically converted into one share of common stock, such that there were no shares of Series C Convertible Preferred Stock issued or outstanding at June 30, 2017.

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 ofsold 420,000 shares of common stock to LPC for net proceeds of approximately $1,291,000.

April 2018 Registered Direct Offering and Private Placement – On April 11, 2018, the Company closed a registered direct offering of 1,510,604 shares of the Company’s common stock at a purchase price of $3.15 per share (the “Milestone SharesOffering”) equalpursuant to the sumSecurities Purchase Agreement dated as of 251,909April 9, 2018, by and among the Company and each purchaser identified on the signature pages thereto. In a concurrent private placement, the Company sold warrants (the “Warrants”) to purchase a total of 1,132,953 shares of common stock plusat a purchase price of $0.125 per underlying warrant share and with an additional numberexercise price of $3.15 per share (the “Private Placement”). In connection with the Offering and Private Placement, the Company issued warrants to purchase a total of 75,530 shares of common stock equal to 13%with an exercise price of the common stock issued upon exercise of any warrants issued under the Company’s underwritten public offering in December 2016, but only$4.0546 per share to the extent that such warrants have beenplacement agent, H.C. Wainwright & Co., LLC (the “Placement Agent Warrants”). Assuming the Warrants and Placement Agent Warrants are not exercised, priornet proceeds to the milestone being achieved or (ii) payCompany from the equivalent value ofOffering and Private Placement were $4,210,000 after deducting placement agent fees and offering expenses paid by the Milestone Shares in cash. The Company received shareholder approval in accordance with Rule 5635 of the NASDAQ Marketplace Rules at its 2017 Annual Meeting of Stockholders to issue any shares in satisfaction of the achievement of the milestones.Company.

The Company assessed the Milestone SharesWarrants and Placement Agent Warrants under the FASB ASC Topic 480, “Distinguishing Liabilities from Equity” (“ASC 480”). The Company and determined that liability accounting would be required for the Milestone Shares underWarrants and Placement Agent Warrants were outside the scope of ASC 480. The Company will record a liability related tonext assessed the Milestone Shares ifWarrants and whenPlacement Agent Warrants under the milestones are achieved and the consideration becomes payable. At that time, the Company will record the cost of the Milestone Shares asin-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 Company’s financial assets and liabilities that arere-measured and reported at fair value at each reporting period and arere-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.

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 management’s best estimate of what market participants would use to price the assets or liabilities at the measurement date.

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 entity’s 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 June 30, 2017   Quoted Prices in
Active Markets
(Level 1)
   Other Significant
Observable Inputs
(Level 2)
   Significant
Unobservable Inputs
(Level 3)
 

Assets:

        

Warrant in Thera

  $5   $—     $—     $5 
  

 

 

   

 

 

   

 

 

   

 

 

 

Total

  $5   $—     $—     $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:

        

Warrant in Thera

  $5   $—     $—     $5 
  

 

 

   

 

 

   

 

 

   

 

 

 

Total

  $5   $—     $—     $5 
  

 

 

   

 

 

   

 

 

   

 

 

 

A reconciliation of the beginning and ending Level 3 assets for the six months ended June 30, 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 and accounts payable approximate their fair values due to their short-term nature.

6. Stockholders’ Equity

Series B Convertible Preferred Stock The Company’s remaining shares of Series B Convertible Preferred Stock (“Series B Convertible Preferred Stock”) outstanding at December 31, 2016 were fully converted into 637,445 shares of common stock of the Company during the first quarter of 2017, such that there are no shares of Series B Convertible Preferred Stock issued or outstanding at June 30, 2017.

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 Convertible Preferred Stock. The Series C Convertible 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 anas-converted basis at the same time and in the same form as any dividends paid out on shares of the Company’s common stock. Other than as set forth in the previous sentence, no other dividends shall be paid on the Series C Convertible 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 Convertible Preferred Stock was assessed under ASC 480. The Company determined that the Series C Convertible Preferred Stock was not within the scope of ASC 480 and therefore, the Series C Convertible Preferred Stock was not considered a liability. The Series C Convertible Preferred Stock was recorded in permanent equity on the Company’s balance sheet.

The Series C Convertible Preferred Stock was then assessed under FASB ASC 815, “Derivatives and Hedging” (“ASC 815”). Under the related guidance, a reporting entity shall not consider a contract to be a derivative instrument if the contract is both (1) indexed to the entity’s own stock and (2) classified in stockholders’ equity. The Company believesdetermined that the Series C Convertible Preferred Stock is an equity host forWarrants and Placement Agent Warrants were indexed to the purposesCompany’s stock, as the agreements do not contain any exercise contingencies and the settlement amount equals the difference between the fair value of assessing the embedded conversion option for potential bifurcation.Company’s common stock price and the strike price. The Company concluded thatalso assessed the conversion option feature is clearlyclassification in stockholders’ equity and closely related todetermined the preferred stock host. As such,Warrants and Placement Agent Warrants met all of the conversion feature did not require bifurcationcriteria for classification as equity under ASC 815.

Pursuant to the Stock Purchase Agreement, Based on this analysis, the Company acquired all ofdetermined that the issuedWarrants 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 Company was restricted from converting any of the Series C Convertible Preferred Stock into common stock to the extent that such conversion was not approved by the Company’s stockholdersPlacement Agent Warrants would be classified in accordance with the stockholder approval requirements of NASDAQ Marketplace Rule 5635. On June 9, 2017, with the approval of the Company’s stockholders in accordance with the NASDAQ stockholder approval requirements, every ten shares of the Series C Convertible Preferred Stock outstanding were automatically converted into one share of common stock, such that there were no shares of Series C Convertible Preferred Stock issued or outstanding at June 30, 2017. Please refer to Note 4 for further details on the shares issued in connection with the acquisition of MirImmune.

stockholders’ equity.

9

Warrants —The following table summarizes the Company’s outstanding equity-classified warrants at June 30, 2017:2018:

 

Exercise prices

  Number of Shares
Underlying Warrants
   Expiration 

$52.00

   130,007    June 2, 2020 

$9.00

   1,277,993    December 21, 2021 
  

 

 

   

Total warrants outstanding

   1,408,000   
  

 

 

   
        
Exercise price  Number of Shares
Underlying Warrants
  Expiration 
$52.00   130,007   June 2, 2020 
$9.00   1,277,793   December 21, 2021 
$3.15   1,132,953   May 31, 2023 
$4.0546   75,530   April 9, 2023 
 Total warrants outstanding   2,616,283     

During

6. Net Loss per Share

The following table sets forth the three months ended June 30, 2017, 46potential common shares excluded from the calculation of the Company’s outstanding warrants with an exercise price of $390.00 expired.net loss per share because their inclusion would be anti-dilutive:

No warrants were exercised during the three or six months ended June 30, 2017 or 2016.

  June 30, 
  2018  2017 
Options to purchase common stock  53,180   67,745 
Warrants to purchase common stock  2,616,283   1,407,800 
Total  2,669,463   1,475,545 

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 and six months ended June 30, 20172018 and 2016,2017, the following assumptions were used:

 

  For the Three Months Ended
June 30,
   For the Six Months Ended
June 30,
  For the Three Months Ended
June 30,
 For the Six Months Ended
June 30,
 
  2017 2016   2017 2016  2018 2017 2018 2017 

Risk-free interest rate

   1.73 – 2.25% N/A    1.73 – 2.49 1.18 – 2.02 2.93% 1.73 – 2.25% 2.70 – 2.93% 1.73 – 2.49%

Expected volatility

   82.99 – 115.18 N/A    82.99 – 123.01 79.42 – 116.70 95.77% 82.99 – 115.18% 91.28 – 95.77% 82.99 – 123.01%

Weighted average expected volatility

   85.51 N/A    84.63 88.64 95.77 85.51 92.84 84.63%  

Expected lives (in years)

   5.20 – 10.00  N/A    5.20 – 10.00  5.20 – 10.0  5.50  5.20 – 10.00  5.50 – 10.00  5.20 – 10.00

Expected dividend yield

   0.00 N/A    0.00 0.00 0.00% 0.00% 0.00% 0.00%

10

The weighted average fair value of options granted during the three months ended June 30, 2018 and 2017 was $4.70. There were no options granted during the three months ended June 30, 2016.$1.72 and $4.70, respectively. The weighted average fair value of options granted during the six months ended June 30, 2018 and 2017 was $2.80 and 2016 was $4.90, and $21.50, respectively.

The risk-free interest rate used for each grant wasis based upon the yield onzero-coupon U.S. Treasury securities with a term similar to the expected life of the related option. The Company’s expected stock price volatility assumption is based upon the volatility of a composition of comparable companies.Company’s own implied volatility. The expected life assumption for employeeoption grants wasis based upon the simplified method provided for under ASC 718, and the expected life assumption fornon-employees was based upon the contractual term of the option.718. 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 Company’s stock option plan for the six months ended June 30, 2017:2018:

 

   Total Number
of Shares
   Weighted-
Average
Exercise
Price
Per Share
   Aggregate
Intrinsic
Value
 

Balance at December 31, 2016

   37,444   $272.90   

Granted

   32,838    6.90   

Exercised

   —      —     

Cancelled

   (2,537   262.80   
  

 

 

   

 

 

   

 

 

 

Balance at June 30, 2017

   67,745   $144.30   $—   
  

 

 

   

 

 

   

 

 

 

Exercisable at June 30, 2017

   32,831   $281.50   $—   
  

 

 

   

 

 

   

 

 

 
   Total Number
of Shares
  Weighted-
Average
Exercise
Price
Per Share
  Aggregate
Intrinsic
Value
 
 Balance at December 31, 2017   50,180  $192.30     
 Granted   3,000   3.32     
 Exercised           
 Cancelled           
 Balance at June 30, 2018   53,180  $181.63  $ 
 Exercisable at June 30, 2018   37,881  $250.86  $ 

The Company recorded stock-based compensation expense in the condensed consolidated statement of operations for the three and six months ended June 30, 20172018 and 20162017 as follows, in thousands:

 

   Three Months Ended   Six Months Ended 
   June 30,   June 30, 
   2017   2016   2017   2016 

Research and development

  $40   $88   $73   $160 

General and administrative

   79    139    160    361 
  

 

 

   

 

 

   

 

 

   

 

 

 

Total stock-based compensation

  $119   $227   $233   $521 
  

 

 

   

 

 

   

 

 

   

 

 

 

  Three Months Ended  Six Months Ended 
  June 30,  June 30, 
  2018  2017  2018  2017 
Research and development $11  $40  $20  $73 
General and administrative  26   79   58   160 
Total stock-based compensation $37  $119  $78  $233 

Stock-based compensation expense for the three and six months ended June 30, 2017 includes $22,000, recorded in research and development expense, related to stock option modifications in connection with the retirement of the Company’s former Chief Development Officer.

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:

 

   June 30, 
   2017   2016 

Options to purchase common stock

   67,745    38,996 

Warrants to purchase common stock

   1,408,000    255,697 
  

 

 

   

 

 

 

Total

   1,475,745    294,693 
  

 

 

   

 

 

 

9. Subsequent Events

On August 8, 2017, the Company entered into a purchase agreement (the “Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“LPC”), pursuant to which the Company has the right to sell to LPC up to $15,000,000 in shares of the Company’s common stock, subject to certain limitations and conditions set forth therein, over the30-month term of the Purchase Agreement. Pursuant to the Purchase Agreement, the Company issued 45,000 shares of common stock to LPC as a commitment fee.

 

11

ITEM 2.

ITEM 2.

MANAGEMENT’S 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 management’s discussion and analysis of financial condition as of June 30, 20172018 and results of operations for the three and six months ended June 30, 20172018 and 20162017 should be read in conjunction with the financial statements included in our Annual Report onForm 10-K for the year ended December 31, 20162017, which was filed with the SECSecurities and Exchange Commission on March 30, 2017.26, 2018.

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. Suchreferences, although not all forward-looking statements include, but are not limited to, statements about: our ability to successfully developRXI-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.contain these words. 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 anystatements as a result of these forward-looking statements. Importanta number of 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 or clearance of common warts; 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 Form10-K for the year ended December 31, 20162017 under the heading “Risk Factors” and in other filings the Company periodically makes with the Securities and Exchange Commission. Therefore, you should not rely on any of these forward-looking statements. Forward-looking statements contained in this Quarterly Report on Form10-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.

Overview

RXi Pharmaceuticals Corporation (“RXi,” “we,” “our” or the “Company”) is a clinical-stagebiotechnology company developing innovativethe next generation of immuno-oncology therapeutics based on our proprietaryits self-delivering RNAi( (“sd-rxRNA®) platformtherapeutic platform. Our sd-rxRNA compounds do not require a delivery vehicle to penetrate the cell 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 Company’s clinical development programs includeRXI-109, ansd-rxRNA for the treatment of dermal and ocular scarring, and Samcyprone™, a topical immunomodulator, for the treatment of warts. The Company’s 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 Company’s first RNAi clinical product candidate,RXI-109, isWe believe that this provides the Company with a self-delivering RNAi compound(sd-rxRNA) that commenced human clinical trialsdistinct advantage in 2012.RXI-109 is designed to reduce the expression of connective tissue growth factoradoptive cell transfer (“CTGFACT”), 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 ofRXI-109 to prevent the progression of retinal scarring in subjects with wetage-related macular degeneration (“AMD”).

Study 1402, therapy, the Company’s 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 judgedinitial focus and approach to be better at three months after a treatment regimen with five mg/cm intradermal administration ofRXI-109immuno-oncology. 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 ofRXI-109 over asix-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 ofRXI-109 at three months. In addition, these data extend this observation to all time points, including the post-treatmentfollow-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 completeread-out of the whole study, including all four cohorts withfollow-up until nine months post-surgery, is expected in the second half of 2017.

Study 1501,Prior to the Company’s 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 evidenceacquisition of subretinal fibrosis. Each subject receives four doses ofRXI-109 by intraocular injection at one month intervals for a total dosing period of three months. The safety and tolerability ofRXI-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. To date, there have been no safety issues that have precluded continuation of dosing. Study 1501 has been completely enrolled and dosing in the third cohort at the highest planned dose level is ongoing. The Company expects to complete subject participation in the study by the end of 2017 and to share top-line data in early 2018.

Samcyprone™, the Company’s second clinical candidate, is a proprietary topical formulation of the small molecule diphenylcyclopropenone (“DPCP”), an immunomodulator that works by initiating aT-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 subject’s 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 aten-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 theten-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 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. Early read-outs of the study are anticipated in the second half of 2017.

In addition to our clinical programs, we continue to advance our preclinical and discovery programs with oursd-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, ansd-rxRNA compound targeting TYR, is in development as a cosmetic ingredient that may improve the appearance of uneven skin tone and pigmentation.RXI-185, ansd-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 forRXI-231 was successfully completed in December 2016. The Company initiated human testing ofRXI-231 in June 2017 with a U.S. clinical testing site. In addition to evaluating safety, the Company will assess the effect ofRXI-231 on the appearance of skin pigmentation in afollow-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”), in January 2017, the stockholdersCompany’s principal activities consisted of MirImmune set forththe preclinical and clinical development of our sd-rxRNA compounds and topical immunotherapy agent in the areas of dermatology and ophthalmology. In January 2018, after a thorough review of our business operations, development programs and financial resources, the Company made a strategic decision to focus solely on immuno-oncology to accelerate growth and support a potential return on investment for its stockholders. The Company’s business strategy focuses on the signature pages thereto (eachdevelopment of immuno-oncology therapeutics utilizing our proprietary sd-rxRNA technology. The Company intends to seek a Sellerpartner and/or out-licensee for both its dermatology and collectively, the “Sellers”)ophthalmology franchises, including RXI-109 and Samcyprone™, and Alexey Wolfson, Ph.D., in his capacity as the Sellers’ Representative. Pursuant to the Stock Purchase Agreement,continue their development. The goal of any such transaction would be to allow the Company acquiredto monetize these preclinical and clinical assets to further fund ongoing and future development work in our immuno-oncology programs and extend our financial runway.

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In ACT, immune cells are isolated from specific patients or retrieved from allogeneic immune cell banks, which are banks of cells donated from healthy volunteers. The immune cells are then expanded and modified before being returned and used to treat the Sellers allsame patient. We believe our sd-rxRNA compounds are ideally suited to be used in combination with ACT, in order to make these immune cells more effective. Our approach involves the treatment of the issuedimmune cells with our sd-rxRNA compounds during the expansion and outstanding shares of capital stock of MirImmune for an aggregate of 275,036 shares of common stock ofmodification phase. Because our sd-rxRNA compounds do not require a delivery vehicle to penetrate into the Company and an aggregate of 1,118,224 shares of Series C Convertible Preferred Stock (the “Series C Convertible Preferred Stock”). On June 9, 2017, withcells, we are able to enhance these cells (for example by inhibiting the approval of the Company’s stockholders in accordance with the stockholder approval requirements of Nasdaq Marketplace Rule 5635, every ten shares of the Company’s Series C Convertible Preferred Stock outstanding were automatically converted into one share of common stock, such that no shares of Series C Convertible Preferred Stock remained issued or outstanding.

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.

Building on the work completed by MirImmune prior to its acquisition by the Company, our cell-based cancer immunotherapy program with sd-rxRNA includes lead compounds for a numberexpression of immune checkpoint targets that provide long lasting immune checkpoint silencing, individually and in combination, in adoptively transferred cells. An improved efficacy upongenes) by merely adding our sd-rxRNA compounds during the silencing of checkpoints has been demonstrated inexpansion process. After enhancing these cells ex-vivo, they are returned to the patient for treatment. In various types of adoptively transferredimmune cells relevanttested to date, the sd-rxRNA treatment results in cancer immunotherapy, such as CAR T-cellspotent silencing while maintaining close to 100% transfection efficiency and tumor infiltrating lymphocytes (TILs). The Company’s ongoingnearly full cell viability.

We believe that our sd-rxRNA therapeutics are uniquely positioned in the immuno-oncology field for the following reasons:

·Our sd-rxRNA compounds do not need facilitated delivery (mechanical or formulation);
·Can target multiple genes (i.e. multiple immunosuppression pathways) in a single therapeutic entity;
·Demonstrated efficient uptake of sd-rxRNA to immune cells;
·Silencing by sd-rxRNA has been shown to have a sustained (long-term) effectin vivo;
·Favorable clinical safety profile of sd-rxRNA with local administration; and
·Can be readily manufactured under current good manufacturing practices.

We currently have discovery and preclinical programs include, butto develop our sd-rxRNA targeting PD-1, TIGIT and other undisclosed checkpoints in ACT for the treatment of solid tumors. We are not limitedalso developing sd-rxRNA against multiple undisclosed targets that influence cell differentiation and metabolism for use in ACT to the evaluation oftreat hematologic cancers and solid tumors.

Our most advanced immuno-oncology programs are RXI-762 and RXI-804, sd-rxRNA compounds that are designed to silence targets related to cytokine release syndrome. The Company has also initiated in vivo evaluations of multiple checkpoint inhibiting sd-rxRNA compounds co-transfected in CAR T-cells in mouse models for solid tumors, with data from this study expected in the second half of 2017.

Additionally, the Company recently selected two sd-rxRNA compounds from its immunotherapy pipeline for preclinical development. For oncology treatments based on adoptive cell transfer (ACT), compounds RXI-762 and RXI-804 suppress the expression of immune checkpoint proteins PD-1 and TIGIT, respectively, which, canwhen used in ACT, are expected to result in an improved efficacy to the targeted tumors. This decision triggeredIn August 2017, the Company announced the selection of a manufacturing facility to initiate production of cGMP grade material, initially for the first of these two sd-rxRNA compounds (RXI-762). This also supports moving RXI-762 intofor preclinical development in ACT for solid tumors. We expect to enter clinical development as early as 2018with RXI-762 as part of an ACT therapy.therapy for solid tumors within the next 12 – 18 months.

On August 8, 2017,

We are advancing these compounds and our other discovery and preclinical ACT compounds towards clinical development, both independently and with our strategic collaborations. We plan to focus our internal resources on therapeutic areas where research and development is appropriate for the size and financial resources of the Company entered into a purchase agreement (the “Purchase Agreement”)and to seek partners in therapeutic areas with Lincoln Park Capital Fund, LLC (“LPC”), pursuantthe requisite expertise and resources to whichadvance our product and research candidates through clinical development. To that end, we have established research collaborations with the Center for Cancer Immune Therapy at Herlev Hospital (a leading European cancer center); Gustave Roussy (a leading comprehensive cancer center in Europe); Medigene AG (a German biotechnology company); PCI Biotech (a private biotechnology firm); the University of Minnesota (a highly ranked public research university) and Iovance Biotherapeutics, Inc. (a biotechnology company developing novel cancer immunotherapies).

One aspect of our ongoing strategy is to build upon these current collaborations to add additional partnerships to our immuno-oncology pipeline. If results from these collaborations and others are positive, the synergies between the Company’s technology and its partner’s technology and expertise may provide multiple avenues for human clinical testing of the Company’s sd-rxRNA compounds in ACT within the next 12 – 18 months.

13

While the Company announced in January 2018 that its current business strategy is to focus solely on its immuno-oncology pipeline development, the Company has completed its clinical trials in dermatology and ophthalmology with RXI-109, our first sd-rxRNA clinical candidate, and Samcyprone™. In parallel, the rightCompany intends to sellpartner and/or out-license each of its dermatology and ophthalmology franchises, including RXI-109 and Samcyprone™, to LPC up to $15,000,000 in sharescontinue their development. The status of the Company’s common stock, subject to certain limitations and conditions set forth therein, over the30-month term of the Purchase Agreement.

Since inception, we have incurred significant losses. Substantially all of our losses to date have resulted from research and development expenses in connectionclinical trials with our clinical and research programs and from general and administrative costs. At June 30, 2017, we had an accumulated deficit of $74.1 million. We expect to continue to incur significant losses for the foreseeable future, particularly as we advance our development programs forRXI-109 and Samcyprone™ and expand our program in cell-based cancer immunotherapy.is as follows:

·In December 2017, the Company announced positive results with RXI-109 in a Phase 2 open-label, multi-center, prospective, within-subject controlled study evaluating the effectiveness and safety of RXI-109 on the outcome of scar revision surgery for hypertrophic scars in healthy adults. The primary effectiveness objective was met as shown by a statistically significant improved visual appearance of revised scars after scar revision surgery and treatment with RXI-109 versus control, as assessed by the investigator. The full study results showed that the product was safe and well tolerated for all dosage groups. Exploratory endpoint analysis furthermore showed that the cosmetic outcomes of RXI-109 treated scars were highly preferred over the untreated revised scars, by both investigators and patients.

·In May 2018, the Company announced results from our Phase 2 clinical trial with Samcyprone™ in cutaneous warts. The primary effectiveness objectives were met as shown by high levels of immunotherapeutic response and therapeutic response. The immunotherapeutic response rate – a prerequisite for therapeutic response – was 97.7% across all 88 subjects enrolled in the study. From a therapeutic response viewpoint, with once weekly dosing for up to 10 weeks, more than 70% of all warts showed a positive wart response rate, i.e. reduction of wart size of more than 50%. Complete wart clearance throughout the study was 54% for all warts, and up to 71.4% for certain wart types (non-plantar warts). The study results show furthermore that Samcyprone™ was safe and well tolerated.

·In August 2018, the Company announced positive results from our Phase 1/2 clinical trial to evaluate the safety and clinical activity of RXI-109 in reducing the progression of retinal scarring. The trial was a multi-dose, dose escalation study conducted in subjects with wet age-related macular degeneration with evidence of subretinal fibrosis. Each subject in the study received four doses of RXI-109 by intraocular injection at one-month intervals for a total dosing period of three months. The primary objective was met as shown by the absence of dose-limiting and serious toxicities, and only mild to moderate procedure related adverse events. None of the adverse events were drug related. In addition, comprehensive ocular examinations showed no indications of inflammation nor any other tolerability issues related to the treatment. The secondary objective of the study was also met with improved or stable disease in the study eyes of several subjects.

On January 3, 2018, the Board of Directors of the Company approved a 1-for-10 reverse stock split of the Company’s 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.capital in the financial statements.

On April 11, 2018, the Company closed a registered direct offering of 1,510,604 shares of the Company’s common stock at a purchase price of $3.15 per share (the “Offering”) pursuant to the Securities Purchase Agreement dated as of April 9, 2018, by and among the Company and each purchaser identified on the signature pages thereto. In a concurrent private placement, the Company sold warrants (the “Warrants”) to purchase a total of 1,132,953 shares of common stock at a purchase price of $0.125 per underlying warrant share and with an exercise price of $3.15 per share (the “Private Placement”). In connection with the Offering and Private Placement, the Company issued warrants to purchase a total of 75,530 shares of common stock with an exercise price of $4.0546 per share to the placement agent, H.C. Wainwright & Co., LLC (the “Placement Agent Warrants”). Assuming the Warrants and Placement Agent Warrants are not exercised, net proceeds to the Company from the Offering and Private Placement were $4,210,000 after deducting placement agent fees and offering expenses paid by the Company.

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 “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section of our Annual Report on Form10-K for the year ended December 31, 2016,2017, which we filed with the SEC on March 30, 2017.

26, 2018.

Results of Operations

The following data summarizes the results of our operations for the periods indicated, in thousands:

 

 Three Months Ended June 30,     Six Months Ended June 30,    
  Three Months Ended
June 30,
   Six Months Ended
June 30,
 
  2017   2016   2017   2016 

Net revenues

  $—     $9   $—     $19 
Description 2018  2017  

Dollar

Change

  2018  2017  Dollar Change 
Revenues $58  $  $58  $81  $  $81 

Operating expenses

   (2,514   (2,224   (9,595   (4,479  (1,957)  (2,514)  557   (4,219)  (9,595)  5,376 

Operating loss

   (2,514   (2,215   (9,595   (4,460  (1,899)  (2,514)  615   (4,138)  (9,595)  5,457 

Income tax benefit

   —      —      1,621    —                 1,621   (1,621)

Net loss

   (2,514   (2,212   (7,974   (4,443  (1,901)  (2,514)  613   (4,140)  (7,974)  3,834 

14

Comparison of the Three and Six Months Ended June 30, 20172018 and 20162017

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
June 30,
   Six Months Ended
June 30,
 
   2017   2016   2017   2016 

Net revenues

  $—     $9   $—     $19 
  

 

 

   

 

 

   

 

 

   

 

 

 
   Three Months Ended June 30,     Six Months Ended June 30,    
Description  2018  2017  

Dollar

Change

  2018  2017  Dollar Change 
 Revenues  $58  $  $58  $81  $  $81 

Net revenues were approximately $9,000

Revenues for the three months ended June 30, 2016 and related to the value of the common stock and warrant issued by Thera Neuropharma, Inc. (“Thera”) to the Company per the terms of the exclusive licensing agreement with Thera.

Net revenues were approximately $19,000 for the six months ended June 30, 2016 and2018 related to the Company’s exclusive license agreements with Thera and MirImmune, Inc. (“MirImmune”), prior to its acquisitionwork performed by the Company.Company as a sub-awardee under the government grant issued to our collaborator BioAxone Biosciences, Inc. from the National Institute of Neurological Disorders and Stroke. The grant provides funding for the development of a novel sd-rxRNA compound, BA-434, that targets PTEN for the treatment of spinal cord injury. There were no revenues for the three and six months ended June 30, 2017.

Operating Expenses

The following table summarizes our total operating expenses, for the periods indicated, in thousands:

 

 Three Months Ended June 30,     Six Months Ended June 30,    
  Three Months Ended
June 30,
   Six Months Ended
June 30,
 
  2017   2016   2017   2016 
Description 2018  2017  

Dollar

Change

  2018  2017  

Dollar

Change

 

Research and development

  $1,329   $1,339   $2,676   $2,644  $1,183  $1,329  $(146) $2,544  $2,676  $(132)

Acquiredin-process research and development

   85    —      4,696    —        85   (85)     4,696   (4,696)

General and administrative

   1,100    885    2,223    1,835   774   1,100   (326)  1,675   2,223   (548)
  

 

   

 

   

 

   

 

 

Total operating expenses

  $2,514   $2,224   $9,595   $4,479  $1,957  $2,514  $(557) $4,219  $9,595  $(5,376)
  

 

   

 

   

 

   

 

 

Research and Development Expenses

Research and development expenses consist 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 $1,329,000relate to salaries, employee benefits, facility-related expenses, supplies, stock-based compensation related to employees and non-employees involved in the Company’s 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.

Research and development expenses for the three months ended June 30, 2017,2018 decreased 11% compared with $1,339,000 for the three months ended June 30, 2016. The decrease of $10,000, or less than 1%, was2017, primarily due to a decrease in clinical-trial related expenses as subject participation is now complete for all of $48,000 in stock-based compensation expense, offset by an increase of $38,000 in research and development expenses primarily driven by subject visits as the Company ramps up enrollment in the second cohort of our Phase 2Company’s clinical trial with Samcyprone™.

trials.

Research and development expenses were $2,676,000 for the six months ended June 30, 2017,2018 decreased 5% compared with $2,644,000 for the six months ended June 30, 2016. The increase of $32,000, or 1%, was2017, primarily due to an increase of $119,000decreases in researchclinical-trial and developmentmanufacturing related expenses primarily related to the completion of subject visitsfor RXI-109 and new enrollmentsSamcyprone™, offset by increases in lab supplies and manufacturing fees for the Company’s Phase 2 clinical trial with Samcyprone™ and the commencement of work in the Company’s cell-based cancer immunotherapy program with the acquisition of MirImmune, offset by a decrease of $87,000 in stock-based compensation expense.immuno-oncology program.

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AcquiredIn-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, in exchange for securities of the Company. The Company determined that the acquired assets did not constitute a business and that the transaction would be accounted for as an asset acquisition. As the assets and development programs acquired from MirImmune were at an early stage of development and determining the future economic benefit of the acquired assets at the date of acquisition was highly uncertain, the fair value of the assets was fully expensed as in-process research and development expense.

During the three months ended June 30, 2017, the Company recorded $85,000 in

There was no acquired in-process research and development expense related toduring the fair value of consideration forthree and six months ended June 30, 2018. During the holdback shares released. During thethree and six months ended June 30, 2017, the Company recorded $4,696,000 inacquired in-process research and development expense related to the fair value of consideration given, which includesincluded transaction costs, liabilities assumed and cancellation of notes receivable, and the deferred tax impact of the MirImmune acquisition.acquisition of MirImmune.

General and Administrative Expenses

General and administrative expenses consist primarily of compensation-related costs for ourrelate to salaries, employee benefits, facility-related expenses, stock-based compensation expense related to employees dedicated to general and administrative activities,activities. Other general and administrative expenses include professional fees for legal, fees, audit, tax and tax fees, consulting fees, professional service fees andservices, as well as other general corporate expenses.

General and administrative expenses were $1,100,000 for the three and six months ended June 30, 2017,2018 compared with $885,000 for the three months ended June 30, 2016. The increase of $215,000, or 24%, was due to an increase of $275,000 in general and administrative expenses due to an increase in employee headcount in connection with the acquisition of MirImmune and increases in legal and accounting fees, offset by a decrease of $60,000 in stock-based compensation expense.

General and administrative expenses were $2,223,000 for the six months ended June 30, 2017 compared with $1,835,000 for the six months ended June 30, 2016. The increase of $388,000, or 21%decreased 30% and 25%, wasrespectively, primarily due to an increasedecreases in professional fees for legal-related services and payroll-related expenses as a result of $589,000 in general and administrative expenses related to an increase in employee headcount in connection with the acquisition of MirImmune and an increase in legal fees, offset by a decrease of $201,000 in stock-based compensation expense.headcount.

Income Tax

The following table summarizes the Company’s income tax for the periods indicated, in thousands:

 

   Three Months Ended
June 30,
   Six Months Ended
June 30,
 
   2017   2016   2017   2016 

Income tax benefit

  $—     $—     $1,621  $—   
  

 

 

   

 

 

   

 

 

   

 

 

 
  Three Months Ended June 30,     Six Months Ended June 30,    
Description 2018  2017  

Dollar

Change

  2018  2017  Dollar Change 
Income tax benefit $  $  $  $  $1,621  $(1,621)

There was no income tax for the three months ended June 30, 2018 or 2017 or for the six months ended June 30, 2018. For the six months ended June 30, 2017, we recognized an income tax benefit of $1,621,000 for the tax-related impact of the Company’s acquisition of MirImmune Inc. onin January 6, 2017. There was no income tax expense or benefit during the three months ended June 30, 2017 and the three months and six months ended June 30, 2016.

Liquidity and Capital Resources

On December 18, 2014, the Company entered into a purchase agreement (the “2014Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“LPC”), pursuant to which the Company had the right to sell to LPC up to $10.8 million in shares of the Company’s common stock, subject to certain limitations and conditions set forth in the 2014 Purchase Agreement. The 2014 Purchase Agreement expired on April 17, 2017. Under the 2014 Purchase Agreement, the Company sold a total of 7,000 shares of common stock to LPC for net proceeds of approximately $216,000.

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 Company’s 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 Convertible 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.

On August 8, 2017, the Company entered into a purchase agreement (the “2017LPC Purchase Agreement”) and a registration rights agreement with Lincoln Park Capital Fund, LLC (“LPC”), pursuant to which the Company has the right to sell to LPC up to $15,000,000 in shares of the Company’s common stock, subject to certain limitations and conditions set forth therein, over the30-month term of the 2017LPC Purchase Agreement. During the six months ended June 30, 2018, the Company sold 420,000 shares of common stock to LPC for net proceeds of approximately $1,291,000. In total, the Company has sold 480,000 shares of common stock to LPC for net proceeds of approximately $1,581,000.

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On April 11, 2018, the Company closed on the Offering and Private Placement of its common stock and the Warrants. Assuming the Warrants and Placement Agent Warrants are not exercised, net proceeds to the Company from the Offering and Private Placement were $4,210,000 after deducting placement agent fees and offering expenses paid by the Company.

We had cash and cash equivalents of $7.7 million$5,315,000 as of June 30, 2017,2018, compared with cash of $12.9 million$3,581,000 as of December 31, 2016. The Company believes2017. We have reported recurring losses from operations since inception and expect that its existingwe will continue to have negative cash andflows from our operations for the potential proceeds available under our equity facility with LPC, should be sufficient to fundforeseeable future. Historically, the Company’s operations for at leastprimary source of funding has been 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 insale of its securities.In the foreseeable future, or ever. We expect to incur significant operating losses as we advance our product candidates through drug development and the 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,or strategic opportunities, in order to maintain our operations and meet our obligations to licensors.operations. There is no guarantee that debt, additional equity or other funding will be available to us on acceptable terms, or at all. The LPC Purchase Agreement should provide us with sufficient funding for our operations for at least the next twelve months. However, certain ownership limitations under the LPC Purchase Agreement preclude us from relying on the full available funds for going concern purposes. As a result of this ownership limitation and based on the Company’s cash, operational spending rate and other available financial resources, the Company has concluded that there is substantial doubt regarding its ability to fund operations for at least the next twelve months. 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:

 

   Six Months Ended
June 30,
 
   2017   2016 

Net cash used in operating activities

  $(5,116  $(4,785

Net cash (used in) provided by investing activities

   (88   3,500 

Net cash provided by (used in) financing activities

   —      —   
  

 

 

   

 

 

 

Net decrease in cash, cash equivalents and restricted cash

  $(5,204  $(1,285
  Six Months Ended
June 30,
 
  2018  2017 
Net cash used in operating activities $(3,767) $(5,116)
Net cash used in investing activities     (88)
Net cash provided by financing activities  5,501    
Net increase (decrease) in cash, cash equivalents and restricted cash $1,734  $(5,204)

Net Cash Flow from Operating Activities

Net cash used in operating activities was $3,767,000 for the six months ended June 30, 2018 compared with $5,116,000 for the six months ended June 30, 2017, compared with $4,785,000 for the six months ended June 30, 2016.2017. The increasedecrease in cash used in operating activities of $1,349,000 was primarily attributable to changes in working capital of $731,000 due to an increase in net loss of $3,531,000, offset by changes innon-cashpayments made for financing-related expenses of $2,795,000 primarily driven by in-process research and development expense related to the fair value of consideration given and the tax-related impact resulting from theCompany’s acquisition of MirImmune in January 2017.the first quarter of the prior year.

Net Cash Flow from Investing Activities

There were no net cash flows related to investing activities for the six months ended June 30, 2018. Net cash used in investing activities was $88,000 for the six months ended June 30, 2017, compared with net cash provided by investing activities of $3,500,000 for the six months ended June 30, 2016.2017. The decrease in net cash flow from investing activities was primarily related to the purchase of laboratory equipment in the current year as compared with maturities of short-term investments in the prior year.

Net Cash Flow from Financing Activities

Net cash provided by financing activities was $5,501,000 for the six months ended June 30, 2018 and was due to proceeds received by the Company from the Offering, Private Placement and the issuance of common stock to LPC. There were no cash flows related to financing activities for the six months ended June 30, 2017 or 2016.2017.

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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 consideredoff-balance sheet arrangements in accordance with ASCAccounting Standards Codification 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 87 to our consolidated financial statements included in our Annual Report on Form10-K for the year ended December 31, 2016,2017, which was filed with the SECSecurities and Exchange Commission on March 30, 2017,26, 2018, for further discussion of these indemnification agreements.

 

ITEM 3.ITEM 3.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Not applicable.

 

ITEM 4.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 our disclosure controls and procedures (asas of the end of the period covered by this report. Disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act)Act of 1934, as of June 30, 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 effectiveamended (the “Exchange Act”), are designed to ensurereasonably assure that information that we are required to disclosebe disclosed in our reports that we file or submitfiled under the Exchange Act isare recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission (the “SEC”) rules and forms.

Subsequently, in connection with the preparation of our Annual Report on Form 10-K, Disclosure controls and procedures are also designed to reasonably assure that such information is accumulated and communicated to our management, withincluding the participation of our Chief Executive Officer and acting Chief Financial Officer, reassessedas appropriate to allow timely decisions regarding required disclosure. We believe that a control system, no matter how well designed and operated, cannot provide absolute assurance that the effectivenessobjectives of the Company’s internal control over financial reporting. In connection with this assessment, we identifiedsystem are met, and no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within a material weakness, as described below, incompany have been detected. Based on the evaluation of our internal control over financial reportingdisclosure controls and procedures as of June 30, 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 misstatementthe end of the annual or interim financial statements will not be prevented or detected on a timely basis. Because of the material weakness, identified below,period covered by this report, management has concluded that as of June 30, 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 operationeffective as of controls that provide reasonable assurance on a timely 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 taxessuch date 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 Company’s 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 June 30, 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 Company’s 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 relatingthat was disclosed in Part II, Item 9A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2017.

Remediation Plan

As previously disclosed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2017, management has implemented a remediation plan to address the control deficiency that led to the material weakness in internal control over financial reporting related to our controls over accounting for income taxes. Management’s planned actions to addressThe remediation plan includes (i) the material weakness include:

Increasedimplementation of increased involvement on a quarterly basis ofwith our third-party tax accountants dedicated to determining the appropriate accounting for material and complex tax transactions in a timely manner;

Reviewmanner, (ii) the review of our tax accounting processprocesses to identify and implement enhanced tax accounting processes and related internal control procedures;procedures and

Establishing (iii) 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 Company’s internal control environment, as well as policies and procedures to improve the overall effectiveness of internal control over financial reporting.

Management believes the implementation of the measures described above that will be implemented will remediate the control deficiencies identified and will strengthen our internal control over financial reporting. The material weakness cannot be considered remediated until the control has operated for a sufficient period of time and until management has concluded, through testing, that the control is operating effectively. We continuously seekexpect these remedial actions to improve and strengthen our control processesbe effectively implemented in order to ensure that allsuccessfully remediate the material weakness by the end 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.2018.

Changes in Internal Control overOver Financial Reporting

There

Other than the changes noted in the Remediation Plan section above, which were implemented during the quarterly period ended March 31, 2018, there has not been any change in our internal control over financial reporting that occurred during the quarterly periodsix months ended June 30, 20172018 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

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PART II — OTHER INFORMATION

 

ITEM 1.ITEM 1.LEGAL PROCEEDINGS

None.

 

ITEM 1A.ITEM 1A.RISK FACTORS

You should

Please carefully consider the “Riskinformation set forth in this Quarterly Report on Form 10-Q and the risk factors discussed in Part I, “Item 1A. Risk Factors” included under Item 1A. ofin our Annual Report on Form10-K for the year ended December 31, 20162017 filed with the SECSecurities and Exchange Commission on March 30, 2017.26, 2018. Our business, financial condition or results of operations could be materially adversely affected by any of these risks. This Quarterly Report on Form 10-Q also contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of certain factors, including these risks.

We mayare not be ablein compliance with the Nasdaq continued listing requirements. If we are unable to regain compliancecomply with the continued listing requirements of Thethe Nasdaq Capital Market.Market, our common stock could be delisted, which could affect our common stock’s market price and liquidity and reduce our ability to raise capital.

On February 2, 2017, we received written notice (the “Notification Letter”) from

Our common stock is listed on the Nasdaq StockCapital Market (“Nasdaq”). The listing rules of the Nasdaq Capital Market require the Company to meet certain minimum requirements, including at least $2.5 million of stockholders’ equity. As of December 31, 2017, we failed to meet this required level of stockholders’ equity and, on March 29, 2018, we received a notice from Nasdaq regarding our non-compliance. On May 31, 2018, the Company received written notice from Nasdaq in response to the Company’s submissions notifying usNasdaq that we are notthe Company had approximately $4.7 million in stockholders’ equity as of March 31, 2018, on a proforma basis. In response to the Company’s submissions explaining its current financial position, Nasdaq is requiring that the Company evidence that it is in compliance by no later than September 25, 2018.

If we fail to comply with the minimum bid price requirements set forth in Nasdaq Listing Rule 5550(a)(2) forCapital Market’s continued listing on The Nasdaq Capital Market. Nasdaq Listing Rule 5550(a)(2) requires listed securities to maintain a minimum bid price of $1.00 per share, and Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum bid price requirement exists if the deficiency continues for a period of 30 consecutive business days. Based on the closing bid price of our common stock for the 30 consecutive business days prior to the date of the Notification Letter,standards, we no longer meet the minimum bid price requirement. The Notification Letter provided an initial180-day period to regain compliance, which was extended for a second180-day period on August 2, 2017. As a result of the extension, we have until January 29, 2018 to regain compliance by maintaining a closing bid price of at least $1.00 per share for a minimum of 10 consecutive business days. In the event that we do not regain compliance by that date, Nasdaq may commence delisting proceedingsbe delisted and our common stock will trade, if at all, only on theover-the counter over-the-counter market, such as the OTC Bulletin Board or OTCQX market, which could adversely impact us by, among other things, reducing the liquidity and then only if one or more registered broker-dealer market pricemakers comply with quotation requirements. In addition, delisting of our common stock; reducing the numberstock could depress our stock price, substantially limit liquidity of investors willing to hold or acquire our common stock; limitingstock and materially adversely affect our ability to issue additional securities in the future; and limiting our abilityraise capitalon terms acceptable to fund our operations.

us, or at all.

ITEM 2.ITEM 2.UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

None.

 

ITEM 3.ITEM 3.DEFAULTS UPON SENIOR SECURITIES

None.

 

ITEM 4.ITEM 4.MINE SAFETY DISCLOSURES

Not applicable.

 

ITEM 5.ITEM 5.OTHER INFORMATION

None.

 

19

ITEM 6.ITEM 6.EXHIBITSEXHIBITS

EXHIBIT INDEX

 

Incorporated by Reference Herein

Exhibit
Number

Description

Form

Date

4.1Form of WarrantCurrent Report on Form 8-K (File No. 001-36304)April 11, 2018
    

Incorporated by Reference Herein

Exhibit
Number

DescriptionFormDate
  3.14.2 Amended and Restated BylawsForm of RXi Pharmaceuticals Corporation, as of June 6, 2017.Placement Agent Warrant

Current Report on Form

8-K (FileNo. 001-36304)

April 11, 2018
 June 9, 2017
10.1Securities Purchase Agreement, dated April 9, 2018, by and between the Company and the Purchasers listed therein.Current Report on Form 8-K (File No. 001-36304)April 11, 2018
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 onForm 10-Q of RXi Pharmaceuticals Corporation for the quarter ended June 30, 2017,2018, formatted in XBRL (eXtensible Business Reporting Language): (1) Condensed Consolidated Balance Sheets as of June 30, 20172018 and December 31, 2016;2017; (2) Condensed Consolidated Statements of Operations for the Three and Six Months Ended June 30, 20172018 and 2016;2017; (3) Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 20172018 and 2016;2017; and (4) Notes to Condensed Consolidated Financial Statements (Unaudited).* 

*Filed herewith.

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SIGNATURES

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,August 14, 2018

 

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