Phio Pharmaceuticals Corp. - Quarter Report: 2015 June (Form 10-Q)
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)
x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2015
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: 000-54910
RXi Pharmaceuticals Corporation
(Exact name of registrant as specified in its charter)
Delaware | 45-3215903 | |
(State of incorporation) | (I.R.S. Employer Identification No.) |
257 Simarano Drive, Suite 101, Marlborough, MA 01752
(Address of principal executive office) (Zip code)
Registrants telephone number: (508) 767-3861
Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes 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 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter time that the registrant was required to submit and post such files). Yes x No ¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See the definitions of large accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer | ¨ | Accelerated filer | ¨ | |||
Non-accelerated filer | ¨ (Do not check if a smaller reporting company) | Smaller reporting company | x |
Indicate by checkmark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No x
As of August 7, 2015, RXi Pharmaceuticals Corporation had 64,949,121 shares of common stock, $0.0001 par value, outstanding.
Table of Contents
RXi PHARMACEUTICALS CORPORATION
FORM 10-Q QUARTER ENDED JUNE 30, 2015
Part No. |
Item No. |
Description |
Page No. |
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I |
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1 |
3 | |||||||
Condensed Balance Sheets as of June 30, 2015 and December 31, 2014 |
3 | |||||||
Condensed Statements of Operations for the three and six months ended June 30, 2015 and 2014 |
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Condensed Statements of Cash Flows for the six months ended June 30, 2015 and 2014 |
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6 | ||||||||
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Managements Discussion and Analysis of Financial Condition and Results of Operations |
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3 |
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II |
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1A |
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PART I FINANCIAL INFORMATION
ITEM 1. | FINANCIAL STATEMENTS |
RXi PHARMACEUTICALS CORPORATION
CONDENSED BALANCE SHEETS
(Amounts in thousands, except share and per share data)
(Unaudited)
June 30, 2015 |
December 31, 2014 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
$ | 5,986 | $ | 8,496 | ||||
Restricted cash |
50 | 50 | ||||||
Short-term investments |
8,000 | | ||||||
Prepaid expenses and other current assets |
718 | 442 | ||||||
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Total current assets |
14,754 | 8,988 | ||||||
Property and equipment, net |
181 | 183 | ||||||
Other assets |
18 | 18 | ||||||
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Total assets |
$ | 14,953 | $ | 9,189 | ||||
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LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
$ | 635 | $ | 285 | ||||
Accrued expenses and other current liabilities |
1,187 | 1,002 | ||||||
Deferred revenue |
| 47 | ||||||
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Total current liabilities |
1,822 | 1,334 | ||||||
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Commitments and contingencies |
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Convertible preferred stock: |
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Series A convertible preferred stock, $0.0001 par value, 15,000 shares authorized; 0 and 5,110 shares issued and outstanding at June 30, 2015 and December 31, 2014, respectively (at liquidation value) |
| 5,110 | ||||||
Stockholders equity: |
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Preferred stock, $0.0001 par value; 10,000,000 authorized |
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Series A-1 convertible preferred stock, $0.0001 par value, 10,000 shares authorized; 0 and 1,578 issued and outstanding at June 30, 2015 and December 31, 2014, respectively (at liquidation value) |
| 1,578 | ||||||
Common stock, $0.0001 par value, 100,000,000 shares authorized; 64,949,121 and 21,984,272 shares issued and outstanding at June 30, 2015 and December 31, 2014, respectively |
6 | 2 | ||||||
Additional paid-in capital |
65,118 | 48,047 | ||||||
Accumulated deficit |
(51,993 | ) | (46,882 | ) | ||||
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Total stockholders equity |
13,131 | 2,745 | ||||||
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Total liabilities, convertible preferred stock and stockholders equity |
$ | 14,953 | $ | 9,189 | ||||
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The accompanying notes are an integral part of these financial statements.
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RXi PHARMACEUTICALS CORPORATION
CONDENSED STATEMENTS OF OPERATIONS
(Amounts in thousands, except share and per share data)
(Unaudited)
Three Months Ended June 30, |
Six Months Ended June 30, |
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2015 | 2014 | 2015 | 2014 | |||||||||||||
Net revenue |
$ | | $ | 12 | $ | 34 | $ | 41 | ||||||||
Operating expenses: |
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Research and development expenses (1) |
1,361 | 1,183 | 3,468 | 2,659 | ||||||||||||
General and administrative expenses (1) |
804 | 850 | 1,677 | 1,693 | ||||||||||||
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Total operating expenses |
2,165 | 2,033 | 5,145 | 4,352 | ||||||||||||
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Operating loss |
(2,165 | ) | (2,021 | ) | (5,111 | ) | (4,311 | ) | ||||||||
Other income (expense) |
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Interest income, net |
1 | 5 | 2 | 11 | ||||||||||||
Other income (expense), net |
(2 | ) | 10 | (2 | ) | 10 | ||||||||||
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Total other income (expense) |
(1 | ) | 15 | | 21 | |||||||||||
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Net loss |
(2,166 | ) | (2,006 | ) | (5,111 | ) | (4,290 | ) | ||||||||
Series A and Series A-1 convertible preferred stock dividends |
(24 | ) | (1,213 | ) | (209 | ) | (2,968 | ) | ||||||||
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Net loss applicable to common stockholders |
$ | (2,190 | ) | $ | (3,219 | ) | $ | (5,320 | ) | $ | (7,258 | ) | ||||
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Net loss per common share applicable to common stockholders: |
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Basic and diluted |
$ | (0.05 | ) | $ | (0.23 | ) | $ | (0.16 | ) | $ | (0.54 | ) | ||||
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Weighted average common shares: basic and diluted |
44,190,583 | 14,015,451 | 34,033,463 | 13,319,634 | ||||||||||||
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(1) Non-cash stock-based compensation expenses included in operating expenses are as follows: |
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Research and development |
$ | 203 | $ | 206 | $ | 378 | $ | 416 | ||||||||
General and administrative |
244 | 251 | 480 | 532 |
The accompanying notes are an integral part of these financial statements.
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RXi PHARMACEUTICALS CORPORATION
CONDENSED STATEMENTS OF CASH FLOWS
(Amounts in thousands)
(Unaudited)
For the Six Months Ended June 30, 2015 |
For the Six Months Ended June 30, 2014 |
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Cash flows from operating activities: |
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Net loss |
$ | (5,111 | ) | $ | (4,290 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
41 | 42 | ||||||
Gain on disposal of equipment |
| (10 | ) | |||||
Non-cash stock-based compensation |
858 | 948 | ||||||
Fair value of common stock issued in exchange for patent and technology rights |
228 | | ||||||
Changes in operating assets and liabilities: |
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Prepaid expenses and other assets |
(276 | ) | (64 | ) | ||||
Accounts payable |
350 | 130 | ||||||
Accrued expenses and other current liabilities |
185 | (1,113 | ) | |||||
Deferred revenue |
(47 | ) | (40 | ) | ||||
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Net cash used in operating activities |
(3,772 | ) | (4,397 | ) | ||||
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Cash flows from investing activities: |
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Purchase of short-term investments |
(8,000 | ) | | |||||
Maturities of short-term investments |
| 3,000 | ||||||
Cash paid for purchase of property and equipment |
(39 | ) | (71 | ) | ||||
Proceeds from disposal of property and equipment |
| 12 | ||||||
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Net cash (used in) provided by investing activities |
(8,039 | ) | 2,941 | |||||
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Cash flows from financing activities: |
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Net proceeds from the issuance of common stock |
9,254 | 1,947 | ||||||
Proceeds from the issuance of common stock upon the exercise of warrants |
16 | | ||||||
Proceeds from the issuance of common stock in connection with the employee stock purchase plan |
31 | 30 | ||||||
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Net cash provided by financing activities |
9,301 | 1,977 | ||||||
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Net increase (decrease) in cash and cash equivalents |
(2,510 | ) | 521 | |||||
Cash and cash equivalents at the beginning of period |
8,496 | 11,390 | ||||||
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Cash and cash equivalents at the end of period |
$ | 5,986 | $ | 11,911 | ||||
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Supplemental disclosure of non-cash investing and financing activities: |
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Exchange of Series A convertible preferred stock into Series A-1 convertible preferred stock |
$ | 2,000 | $ | 3,000 | ||||
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Conversion of Series A and Series A-1 convertible preferred stock into common stock |
$ | 6,814 | $ | 1,025 | ||||
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Fair value of Series A and Series A-1 convertible preferred stock dividends |
$ | 209 | $ | 2,968 | ||||
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Series A and Series A-1 convertible preferred stock dividends |
$ | 127 | $ | 333 | ||||
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The accompanying notes are an integral part of these financial statements.
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RXi PHARMACEUTICALS CORPORATION
NOTES TO CONDENSED FINANCIAL STATEMENTS
(Unaudited)
1. Nature of Business and Basis of Presentation
RXi Pharmaceuticals Corporation (RXi, we, our or the Company) is a biotechnology company focused on discovering and developing innovative therapies, primarily in the areas of dermatology and ophthalmology, addressing high unmet medical needs. Our development programs are based on our siRNA technology and immunotherapy agents. Our clinical development programs include, but are not limited to, our proprietary, self-delivering RNAi (sd-rxRNA®) compounds for the treatment of dermal and ocular scarring and an immunomodulating agent, Samcyprone, for the treatment of such disorders as alopecia areata, warts and cutaneous metastases of melanoma. In addition to these clinical programs, we have a pipeline of discovery and preclinical product candidates in our core therapeutic areas, as well as in other areas of interest. The Companys pipeline, coupled with our extensive patent portfolio, provides support to further discover and develop innovative therapies either on our own or in collaboration with strategic partners.
Basis of Presentation
The accompanying condensed financial statements are unaudited and have been prepared in accordance with accounting principles generally accepted in the United States of America (GAAP). Certain information and footnote disclosures included in the Companys annual financial statements have been condensed or omitted. The year-end condensed balance sheet data was derived from audited financial statements, but does not include all disclosures required by GAAP. In the opinion of management, all adjustments (including normal recurring accruals) considered necessary for a fair presentation of the condensed financial statements have been included. Interim results are not necessarily indicative of results for a full year.
Uses of Estimates in Preparation of Financial Statements
The preparation of financial statements in accordance with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from these estimates.
Cash and Cash Equivalents
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
Restricted cash consists of certificates of deposit held by financial institutions as collateral for the Companys corporate credit cards.
Short-term Investments
Short-term investments consist of certificates of deposit with original maturities ranging from 3 months to 1 year.
Revenue Recognition
The principal source of revenue consists of government research grants. Revenue is recognized provided there is persuasive evidence of an arrangement, the fee is fixed or determinable and collection of the related receivable is reasonably assured, and no contingencies remain outstanding. Payments received prior to the recognition of revenue are recorded as deferred revenue.
Research and Development Expenses
Research and development costs are charged to expense as incurred and relate to salaries, employee benefits, facility-related expenses, supplies, stock-based compensation related to employees and non-employees involved in the Companys research and development, external services, other operating costs and overhead related to our research and development departments, costs to acquire technology licenses and expenses associated with preclinical activities and our clinical trials. Payments made by the Company in advance for research and development services not yet provided and/or for materials not yet received are recorded as prepaid expenses. Accrued liabilities are recorded related to those expenses for which vendors have not yet billed us with respect to services provided and/or materials that we have received.
Preclinical and clinical trial expenses relate to third-party services, subject-related fees at the sites where our clinical trials are being conducted, laboratory costs, analysis costs, toxicology studies and investigator fees. Costs associated with these expenses are generally payable on the passage of time or when certain milestones are achieved. Expense is recorded during the period incurred or in
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the period in which a milestone is achieved. In order to ensure that we have adequately provided for preclinical and clinical expenses during the proper period, we maintain an accrual to cover these expenses. These accruals are assessed on a quarterly basis and are based on such assumptions as expected total cost, the number of subjects and clinical trial sites and length of the study. Actual results may differ from these estimates and could have a material impact on our reported results. Our historical accrual estimates have not been materially different from our actual costs.
Stock-based Compensation
The Company follows the provisions of the Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) Topic 718, Compensation Stock Compensation (ASC 718), which requires the measurement and recognition of compensation expense for all stock-based payment awards made to employees, officers and non-employee directors, including stock options. Stock compensation expense based on the grant date fair value estimated in accordance with the provisions of ASC 718 is recognized as an expense over the requisite service period.
For stock options granted as consideration for services rendered by non-employees, the Company recognizes compensation expense in accordance with the requirements of FASB ASC Topic 505-50, Equity Based Payments to Non-Employees. Non-employee option grants that do not vest immediately upon grant are recorded as an expense over the requisite service period of the underlying stock options. At the end of each financial reporting period prior to vesting, the value of these options, as calculated using the Black-Scholes option-pricing model, will be re-measured using the fair value of the Companys common stock and the non-cash compensation recognized during the period will be adjusted accordingly. Since the fair market value of options granted to non-employees is subject to change in the future, the amount of the future compensation expense will include fair value re-measurements until the stock options are fully vested.
Net Loss per Share
The Company accounts for and discloses net loss per share attributable to common stockholders in accordance with FASB ASC Topic 260, Earnings per Share. Basic and diluted net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted average number of common shares outstanding. When the effects are not anti-dilutive, diluted earnings per share is computed by dividing the Companys net earnings by the weighted average number of common shares outstanding and the impact of all dilutive potential common shares.
Comprehensive Loss
The Companys net loss is equal to its comprehensive loss for all periods presented.
2. Recent Accounting Pronouncements
In August 2014, the FASB issued Accounting Standards Update (ASU) 2014-15, Presentation of Financial Statements Going Concern (Topic 915): Disclosure of Uncertainties about an Entitys Ability to Continue as a Going Concern. ASU 2014-15 states that in connection with preparing financial statements for each annual and interim reporting period, an entitys management should evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the entitys ability to continue as a going concern within one year after the date that the financial statements are issued (or within one year after the date that the financial statements are available to be issued when applicable). ASU 2014-15 will be effective for annual and interim periods beginning on or after December 15, 2016, and will be effective for the Company beginning on January 1, 2017. Early adoption is permitted. The Company is currently evaluating the impact, if any, of the adoption of this update.
In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606). ASU 2014-09 states that an entity should recognize revenue to depict the transfer of promised 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. The new standard will be effective for the Company on January 1, 2018. The Company is currently evaluating the method of adoption and the potential impact the update may have on its financial position and results of operations.
3. Net Loss per Share Attributable to Common Stockholders
The following table sets forth the potential common shares excluded from the calculation of net loss per common share attributable to common stockholders because their inclusion would be anti-dilutive:
June 30, | ||||||||
2015 | 2014 | |||||||
Options to purchase common stock |
3,333,678 | 2,928,932 | ||||||
Common stock underlying Series A and Series A-1 convertible preferred stock |
| 22,626,163 | ||||||
Warrants to purchase common stock |
25,969,615 | 4,615 | ||||||
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Total |
29,303,293 | 25,559,710 | ||||||
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4. Fair Value Measurements
The Company follows the provisions of FASB ASC Topic 820, Fair Value Measurements and Disclosures, for the Companys financial assets and liabilities that are re-measured and reported at fair value at each reporting period and are re-measured and reported at fair value at least annually using a fair value hierarchy that is broken down into three levels. Level inputs are defined as follows:
Level 1 quoted prices in active markets for identical assets or liabilities.
Level 2 other significant observable inputs for the assets or liabilities through corroboration with market data at the measurement date.
Level 3 significant unobservable inputs that reflect managements best estimate of what market participants would use to price the assets or liabilities at the measurement date.
The Company categorized its restricted cash, cash equivalents and short-term investments as Level 2 hierarchy. The assets classified as Level 2 have initially been valued at the applicable transaction price and subsequently valued, at the end of each reporting period, using other market observable data. Observable market data points include quoted prices, interest rates, reportable trades and other industry and economic events. Financial assets measured at fair value on a recurring basis are summarized as follows, in thousands:
Description |
June 30, 2015 | Quoted Prices in Active Markets (Level 1) |
Other Significant Observable Inputs (Level 2) |
Unobservable Inputs (Level 3) |
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Assets: |
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Restricted cash |
$ | 50 | $ | | $ | 50 | $ | | ||||||||
Cash equivalents |
3,000 | | 3,000 | | ||||||||||||
Short-term investments |
8,000 | | 8,000 | | ||||||||||||
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Total |
$ | 11,050 | $ | | $ | 11,050 | $ | | ||||||||
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Description |
December 31, 2014 | Quoted Prices in Active Markets (Level 1) |
Other Significant Observable Inputs (Level 2) |
Unobservable Inputs (Level 3) |
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Assets: |
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Restricted cash |
$ | 50 | $ | | $ | 50 | $ | | ||||||||
Cash equivalents |
4,000 | | 4,000 | | ||||||||||||
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Total |
$ | 4,050 | $ | | $ | 4,050 | $ | | ||||||||
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Fair Value of Financial Instruments
The carrying amounts reported in the balance sheet for restricted cash, cash equivalents, short-term investments and accounts payable approximate their fair values due to their short-term nature.
5. Convertible Preferred Stock
The Company currently has authorized for issuance a total of 15,000 shares of Series A convertible preferred stock (Series A Preferred Stock), $0.0001 par value per share. There were no shares of Series A Preferred Stock outstanding at June 30, 2015.
Dividends
Holders of Series A Preferred Stock are entitled to receive cumulative mandatory dividends at the rate per share of seven percent (7%) of the face amount ($1,000 per share) per annum, payable quarterly on each March 31, June 30, September 30 and December 31. Dividends shall be payable in additional shares of Series A Preferred Stock valued for this purpose at the face amount. The fair value of the Series A Preferred Stock dividend, which is included in the Companys net loss applicable to common shareholders, is calculated by multiplying the number of common shares that a preferred holder would receive upon conversion by the closing price of the Companys common stock on the dividend payment date.
On May 22, 2015, the Company entered into an agreement (the Acceleration and Conversion Agreement) with Tang Capital Partners, L.P. (TCP) pursuant to which the Company and TCP agreed to accelerate the next dividend payment date from June 30, 2015 to no later than May 29, 2015, and upon payment of such dividend immediately convert the dividend shares into common stock. In connection therewith, the dividend payment date was accelerated to May 27, 2015.
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The Company paid dividends in additional shares of Series A Preferred Stock of 21 and 85 shares for the three months ended June 30, 2015 and 2014, respectively. Included in the Companys net loss applicable to common shareholders related to the fair value of the Series A Preferred Stock dividends was $24,000 and $625,000 for the three months ended June 30, 2015 and 2014, respectively.
The Company paid dividends in additional shares of Series A Preferred Stock of 105 and 181 shares for the six months ended June 30, 2015 and 2014, respectively. Included in the Companys net loss applicable to common shareholders related to the fair value of the Series A Preferred Stock dividends was $172,000 and $1,635,000 for the six months ended June 30, 2015 and 2014, respectively.
Conversion
Each holder of shares of Series A Preferred Stock may, at any time and from time to time, convert each of its shares into a number of fully paid and non-assessable shares of common stock at the defined conversion rate. Each share of Series A Preferred Stock is convertible into 2,437.57 shares of common stock. In no event shall any holder of shares of Series A Preferred Stock have the right to convert shares of Series A Preferred Stock into shares of common stock to the extent that, after giving effect to such conversion, the holder, together with any of its affiliates, would beneficially own more than 9.999% of the then-issued and outstanding shares of common stock.
During the three months ended June 30, 2015, 3,106 shares of Series A Preferred Stock were converted into 7,571,218 shares of common stock and during the three months ended June 30, 2014, there were no shares of Series A Preferred Stock converted into shares of common stock.
During the six months ended June 30, 2015, 3,215 shares of Series A Preferred Stock were converted into 7,837,400 shares of common stock and during the six months ended June 30, 2014, 166 shares of Series A Preferred Stock were converted into 405,720 shares of common stock.
Exchange Transaction
On March 20, 2015, the Company entered into an exchange agreement (the Exchange Agreement) with TCP pursuant to which TCP exchanged a total of 2,000 shares of Series A Preferred Stock for a like number of shares of Series A-1 convertible preferred stock (Series A-1 Preferred Stock). The exchange transaction resulted in a decrease in the face value of the Series A Preferred Stock and a corresponding increase in the face value of the Series A-1 Preferred Stock.
6. Stockholders Equity
The Company currently has authorized for issuance 100,000,000 shares of common stock, par value $0.0001 per share, and 10,000,000 shares of preferred stock, par value $0.0001 per share.
Series A-1 Preferred Stock
The Company currently has authorized for issuance a total of 10,000 shares of Series A-1 Preferred Stock, $0.0001 par value per share. There were no shares of Series A-1 Preferred Stock outstanding at June 30, 2015.
Dividends
Holders of Series A-1 Preferred Stock are entitled to receive cumulative mandatory dividends at the rate per share of seven percent (7%) of the face amount ($1,000 per share) per annum, payable quarterly on each March 31, June 30, September 30 and December 31. Dividends shall be payable in additional shares of Series A-1 Preferred Stock valued for this purpose at the face amount. The fair value of the Series A-1 Preferred Stock dividend, which is included in the Companys net loss applicable to common shareholders, is calculated by multiplying the number of common shares that a preferred holder would receive upon conversion by the closing price of the Companys common stock on the dividend payment date.
On May 22, 2015, the Company entered into the Acceleration and Conversion Agreement with TCP pursuant to which the Company and TCP agreed to accelerate the next dividend payment date from June 30, 2015 to no later than May 29, 2015, and upon payment of such dividend immediately convert the dividend shares into common stock. In connection therewith, the dividend payment date was accelerated to May 27, 2015.
The Company paid an immaterial amount of dividends in additional shares of Series A-1 Preferred Stock for the three months ended June 30, 2015. The Company paid dividends in additional shares of Series A-1 Preferred Stock of 80 shares for the three months ended June 30, 2014, respectively. Included in the Companys net loss applicable to common shareholders related to the fair value of the Series A-1 Preferred Stock dividends was $588,000 for the three months ended June 30, 2014.
The Company paid dividends in additional shares of Series A-1 Preferred Stock of 21 and 152 shares for the six months ended June 30, 2015 and 2014, respectively. Included in the Companys net loss applicable to common shareholders related to the fair value of the Series A-1 Preferred Stock dividends was $37,000 and $1,333,000 for the six months ended June 30, 2015 and 2014, respectively.
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Conversion
Each holder of shares of Series A-1 Preferred Stock may, at any time and from time to time, convert each of its shares into a number of fully paid and non-assessable shares of common stock at the defined conversion rate. Each share of Series A-1 Preferred Stock is convertible into 2,437.57 shares of common stock. In no event shall any holder of shares of Series A-1 Preferred Stock have the right to convert shares of Series A-1 Preferred Stock into shares of common stock to the extent that, after giving effect to such conversion, the holder, together with any of its affiliates, would beneficially own more than 9.999% of the then-issued and outstanding shares of common stock.
During the three months ended June 30, 2015, 21 shares of Series A-1 Preferred Stock were converted into 51,759 shares of common stock and during the three months ended June 30, 2014, 353 shares of Series A-1 Preferred Stock were converted into 860,457 shares of common stock.
During the six months ended June 30, 2015, 3,599 shares of Series A-1 Preferred Stock were converted into 8,772,903 shares of common stock and during the six months ended June 30, 2014, 859 shares of Series A-1 Preferred Stock were converted into 2,093,859 shares of common stock.
Exchange Transaction
On March 20, 2015, the Company entered into the Exchange Agreement with TCP pursuant to which TCP exchanged a total of 2,000 shares of Series A Preferred Stock for a like number of shares of Series A-1 Preferred Stock. The terms of the Series A-1 Preferred Stock are identical in all respects to the Series A Preferred Stock, other than the elimination of cash penalties that would potentially be due and payable upon the failure of the Company to have enough shares of common stock available to permit the conversion of Series A Preferred Stock into common stock. The exchange transaction resulted in a decrease in the face value of the Series A Preferred Stock and a corresponding increase in the face value of the Series A-1 Preferred Stock.
Common Stock
Hapten License Agreement
On December 17, 2014, the Company entered into an assignment and exclusive license agreement, (the Hapten Assignment and License Agreement) with Hapten Pharmaceuticals, LLC (Hapten) under which Hapten agreed, effective at a closing that occurred on February 4, 2015, to sell and assign to us certain patent rights and related assets and rights, including an investigational new drug application and clinical data, for Haptens Samcyprone products for therapeutic and prophylactic use. Upon the closing of the Hapten Assignment and License Agreement on February 4, 2015, the Company paid to Hapten a one-time upfront cash payment of $100,000 and issued 200,000 shares of common stock, the fair value of which was determined using the quoted market price of the Companys common stock on the date of issuance. Accordingly, the cash payment of $100,000 and the fair value of the common stock of $228,000 was recorded as research and development expense during the quarter ended March 31, 2015.
Lincoln Park Capital Equity Line
During the six months ended June 30, 2015, the Company sold a total of 50,000 shares of common stock for net proceeds of approximately $64,000 to Lincoln Park Capital Fund, LLC (LPC) pursuant to and subject to the limitations and conditions set forth in that certain purchase agreement (the LPC Purchase Agreement) between the Company and LPC dated December 18, 2014. There were no sales made under the LPC Purchase Agreement during the three months ended June 30, 2015. Per the terms of the public offering (see below), the Company cannot access the equity line until the expiration of the 13-month overallotment purchase rights.
June 2015 Public Offering
On June 2, 2015, the Company sold a total of 26,000,000 units at a price of $0.40 per unit in a public offering (the Offering). Each unit consists of one share of common stock, a 13-month overallotment purchase right to purchase one-half of one share of common stock at a price of $0.455 per full share of common stock (the Overallotment Purchase Rights) and a five-year warrant to purchase one-half of one share of common stock at a price of $0.52 per full share of common stock (the Warrants). As a result of the Offering, the Company received gross proceeds of approximately $10,400,000 and net proceeds of approximately $9,200,000 after placement agent fees and estimated Offering expenses, and assuming the Overallotment Purchase Rights and Warrants are not exercised.
The Company first assessed the Overallotment Purchase Rights and the Warrants under FASB ASC Topic 480 (ASC 480), Distinguishing Liabilities and Equity and determined that the Overallotment Purchase Rights and the Warrants were outside the scope of ASC 480. The Company next assessed the Overallotment Purchase Rights and Warrant under FASB ASC Topic 815 (ASC
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815), Derivatives and Hedging. 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 entitys own stock and (2) classified in stockholders equity. The Company determined that the warrant contracts are indexed to the Companys stock, as the agreements do not contain any exercise contingencies and the warrants settlement amount equals the difference between the fair value of the Companys common stock price and the warrant contract strike price, and the only variables which could affect the settlement amount would be inputs to the fair value for a fixed-for-fixed option on equity shares. The Company also assessed the classification in stockholders equity and determined the warrant contracts meet all of the criteria for classification as equity under ASC 815. Based on this analysis, the Company determined that the Overallotment Purchase Rights and the Warrants should be classified as equity.
During the three months ended June 30, 2015, 35,000 warrants had been exercised for gross proceeds of $16,000. There have been no other warrant exercises to date.
Refer to the Series A Preferred Stock and Series A-1 Preferred Stock conversions described above in this Note and Note 5 for shares issued as a result of the conversions of Series A and Series A-1 Preferred Stock during the three and six months ended June 30, 2015 and 2014, respectively.
7. Stock-Based Compensation
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, 2015 and 2014, the following assumptions were used:
For the Three Months Ended June 30, |
For the Six Months Ended June 30, |
|||||||||||||||
2015 | 2014 | 2015 | 2014 | |||||||||||||
Risk-free interest rate |
1.55 1.83 | % | 1.60 1.95 | % | 1.47 1.83 | % | 1.60 2.73 | % | ||||||||
Expected volatility |
85.63 87.91 | % | 97.91 101.64 | % | 85.63 91.16 | % | 97.91 107.01 | % | ||||||||
Weighted average expected volatility |
86.85 | % | 100.77 | % | 87.62 | % | 101.19 | % | ||||||||
Expected lives (in years) |
5.20 6.25 | 5.20 6.25 | 5.20 6.25 | 5.20 10.0 | ||||||||||||
Expected dividend yield |
0.00 | % | 0.00 | % | 0.00 | % | 0.00 | % |
The weighted average fair value of options granted during the three month periods ended June 30, 2015 and 2014 was $0.28 and $2.26, respectively. The weighted average fair value of options granted during the six month periods ended June 30, 2015 and 2014 was $0.41 and $2.42, respectively.
The risk-free interest rate used for each grant was based upon the yield on zero-coupon U.S. Treasury securities with a term similar to the expected life of the related option. The Companys expected stock price volatility assumption is based upon the volatility of a composition of comparable companies. The expected life assumption for employee grants was based upon the simplified method provided for under ASC 718 and the expected life assumption for non-employees was based upon the contractual term of the option. The dividend yield assumption of zero is based upon the fact that the Company has never paid cash dividends and presently has no intention of paying cash dividends.
The following table summarizes the activity of Companys stock option plan for the period from January 1, 2015 to June 30, 2015:
Total Number of Shares |
Weighted- Average Exercise Price Per Share |
Weighted- Average Remaining Contractual Term |
Aggregate Intrinsic Value |
|||||||||||||
Balance at January 1, 2015 |
3,000,264 | $ | 3.39 | |||||||||||||
Granted |
354,664 | 0.56 | ||||||||||||||
Exercised |
| | ||||||||||||||
Cancelled |
(21,250 | ) | 2.86 | |||||||||||||
|
|
|||||||||||||||
Balance at June 30, 2015 |
3,333,678 | $ | 3.09 | 7.61 years | $ | 30,323 | ||||||||||
|
|
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Exercisable at June 30, 2015 |
2,218,862 | $ | 3.38 | 7.19 years | $ | | ||||||||||
|
|
Stock-based compensation expense for the three months ended June 30, 2015 and 2014 was approximately $447,000 and $457,000, respectively. Of this, the Company recognized approximately $5,300 of income and $9,600 of expense related to non-employee stock options for the same respective periods.
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Stock-based compensation expense for the six months ended June 30, 2015 and 2014 was approximately $858,000 and $948,000, respectively. Of this, the Company recognized approximately $21,800 of income and $46,600 of expense related to non-employee stock options for the same respective periods.
Employee Stock Purchase Plan
The Companys Employee Stock Purchase Plan (ESPP) allows employees to contribute a percentage of their cash earnings, subject to certain maximum amounts, to be used to purchase shares of the Companys common stock on each of two semi-annual purchase dates. The purchase price is equal to 90% of the market value per share on either (a) the date of grant of a purchase right under the ESPP or (b) the date on which such purchase right is deemed exercised, whichever is lower. The maximum number of shares available for issuance pursuant to the ESPP is equal to 113,333 shares.
The Company uses the Black-Scholes option-pricing model to determine the fair value of the ESPP stock rights. There were no stock rights issued during the three months ended June 30, 2015 and 2014. For valuing stock rights issued during the six months ended June 30, 2015 and 2014, the following assumptions were used:
For the Three Months Ended June 30, |
For the Six Months Ended June 30, |
|||||||||||||||
2015 | 2014 | 2015 | 2014 | |||||||||||||
Risk-free interest rate |
N/A | N/A | 0.11 | % | 0.09 | % | ||||||||||
Expected volatility |
N/A | N/A | 82.72 | % | 94.99 | % | ||||||||||
Expected lives (in years) |
N/A | N/A | 0.50 | 0.50 | ||||||||||||
Expected dividend yield |
N/A | N/A | 0.00 | % | 0.00 | % |
The weighted average fair value of stock rights issued during the six months ended June 30, 2015 and 2014 was $0.58 and $1.14, respectively.
The risk-free interest rate used was based upon the yield on zero-coupon U.S. Treasury securities with a term similar to the expected life of the related option. The Companys expected volatility is based upon the volatility of a composition of comparable companies for the expected term. The expected life assumption was based upon the purchase period and 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.
Of the total stock-based compensation expense recorded for the three months ended June 30, 2015 and 2014, the Company recognized $6,500 and $6,600 of expense related to the ESPP for the same respective periods. Of the total stock-based compensation expense recorded for the six months ended June 30, 2015 and 2014, the Company recognized $13,000 and $13,200 of expense related to the ESPP for the same respective periods.
ITEM 2. | MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
In this document, we, our, ours, us, RXi and the Company refer to RXi Pharmaceuticals Corporation.
This managements discussion and analysis of financial condition as of June 30, 2015 and results of operations for the three and six months ended June 30, 2015 and 2014 should be read in conjunction with the financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2014 which was filed with the SEC on March 30, 2015.
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 intend, believe, indicate, plan, expect, may, should, designed to, will and similar references. Such statements include, but are not limited to, statements about: our ability to successfully develop RXI-109, Samcyprone and our other product candidates (collectively our product candidates); the future success of our clinical trials with our product candidates; the timing for the commencement and completion of clinical trials; and the future success of our strategic partnerships. Forward-looking statements are neither historical facts nor assurances of future performance. These statements are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others: the risk that our clinical trials with our product candidates may not be successful in evaluating the safety and tolerability of these candidates or providing evidence of increased surgical scar reduction compared to placebo; the successful and timely completion of clinical trials; uncertainties regarding the regulatory process; the availability of funds and resources to pursue our research and development projects, including our clinical trials with our product candidates; general economic conditions; and those identified in our Annual Report on Form 10-K for the year ended December 31, 2014 under the heading Risk Factors and in other filings the Company periodically makes with the Securities and Exchange Commission.
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Forward-looking statements contained in this Quarterly Report on Form 10-Q speak as of the date hereof and the Company does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this report.
Overview
RXi Pharmaceuticals Corporation (RXi, we, our or the Company) is a biotechnology company focused on discovering and developing innovative therapies, primarily in the areas of dermatology and ophthalmology, addressing high unmet medical needs. Our development programs are based on our siRNA technology and immunotherapy agents. Our clinical development programs include, but are not limited to, our proprietary, self-delivering RNAi (sd-rxRNA®) compounds for the treatment of dermal and ocular scarring and an immunomodulating agent, Samcyprone, for the treatment of such disorders as alopecia areata, warts and cutaneous metastases of melanoma. In addition to these clinical programs, we have a pipeline of discovery and preclinical product candidates in our core therapeutic areas, as well as in other areas of interest. The Companys pipeline, coupled with our extensive patent portfolio, provides support to further discover and develop innovative therapies either on our own or in collaboration with strategic partners.
Our RNAi therapies are designed to silence, or down-regulate, the expression of a specific gene that may be over-expressed in a disease condition. The Companys first RNAi clinical product candidate, RXI-109 is a self-delivering RNAi compound (sd-rxRNA) that commenced human clinical trials in 2012. RXI-109 is designed to reduce the expression of connective tissue growth factor (CTGF), a critical regulator of several biological pathways involved in fibrosis, including scar formation in the skin. RXI-109 is currently being evaluated in Phase 2a clinical trials to prevent or reduce dermal scarring following surgery or trauma, as well as for the management of hypertrophic scars and keloids.
The Company is also directing its development efforts toward advancing RXI-109 forward for the treatment of an ophthalmic indication, of which our current areas of focus include retinal and corneal scarring. To date, we have shown that CTGF protein levels are reduced in a dose-dependent manner in both the retina and cornea following an intravitreal injection of RXI-109 in monkeys. The Company recently filed an investigational new drug application (IND) for RXI-109 as a potential therapeutic for the scarring component of retinal diseases in the eye, such as wet age-related macular degeneration, and following the U.S. Food and Drug Administration 30-day review period, plans to begin a clinical trial in this indication before the end of 2015.
In December 2014, the Company broadened its clinical pipeline with an exclusive, global license to Samcyprone, our second clinical candidate. Samcyprone is a proprietary topical formulation of diphenylcyclopropenone (DPCP), an immunomodulator that works by initiating a T-cell response, and is currently being developed for the treatment of such disorders as warts, alopecia areata and cutaneous metastases of melanoma. The use of Samcyprone allows sensitization using much lower concentrations of DPCP than possible with existing DPCP solutions, avoiding hyper-sensitization to subsequent challenge doses. In March 2015, the Company was granted Orphan Drug Designation for Samcyprone by the U.S. Food and Drug Administration for the treatment of malignant melanoma stage IIb to IV. In addition to an investigator-sponsored clinical trial evaluating the use of Samcyprone in patients with cutaneous metastases of solid tumors, the Company also expects to initiate a Phase 2a clinical trial for the treatment of cutaneous warts with Samcyprone by the end of 2015.
The Company continues to advance additional preclinical and discovery programs using our sd-rxRNA technology. In particular, within our dermatology program, the Company has selected collagenase and tyrosinase as new discovery stage targets for our self-delivering RNAi platform. Collagenase, or MMP1, is a matrix metalloproteinase involved in the breakdown of extracellular matrix. Selected reduction of MMP1 may be beneficial in the treatment of skin aging disorders, arthritis, acne scarring, blistering skin disorders, corneal erosions, endometriosis and possible cancer metastasis. Tyrosinase is the key enzyme in the synthesis of melanin. Melanin is produced by melanocytes and is the pigment that gives human skin, hair and eyes their color. The inhibition of tyrosinase can play a key role in the management of diseases such as cutaneous hyperpigmentation disorders such as lentigines (freckles, age spots and liver spots), and possibly melanoma.
These two discovery targets were selected because they have great potential as clinically relevant pharmaceutical gene targets, however, they also have great potential as cosmeceutical targets. The term cosmeceuticals refers to compounds that can affect the appearance of the skin. For example, by targeting tyrosinase, the superficial reduction of melanin could potentially reduce the darkened skin spots known as age spots and freckles or lighten the skin overall. Cosmeceuticals can be developed more rapidly than pharmaceutical drugs, and the path to market could be much shorter. The Companys next steps include plans to develop a method for skin penetration that would be compatible with our compounds.
Since inception, we have incurred significant losses. Substantially all of our losses to date have resulted from research and development expenses in connection with our clinical and research programs and from general administrative costs. At June 30, 2015, we had an accumulated deficit of $52.0 million. We expect to continue to incur significant losses for the foreseeable future, particularly as we advance our development program for RXI-109 in dermatology and ophthalmology and commence human clinical trials with Samcyprone.
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Research and Development
To date, our research programs have focused on developing technology necessary to make RNAi compounds available by local administration for diseases for which we intend to develop an RNAi therapeutic, identifying and testing RNAi compounds against therapeutically relevant targets in the fields of dermatology and ophthalmology, and identifying lead product candidates and moving those product candidates into the clinic. Since we commenced operations, research and development has comprised a significant proportion of our total operating expenses and is expected to comprise the majority of our spending for the foreseeable future.
There are risks in any new field of drug discovery that preclude certainty regarding the successful development of a product. We cannot reasonably estimate or know the nature, timing and costs of the efforts necessary to complete the development of, or the period in which material net cash inflows are expected to commence from, any product candidate. Our inability to make these estimates results from the uncertainty of numerous factors, including but not limited to:
| Our ability to advance product candidates into preclinical research and clinical trials; |
| The scope and rate of progress of our preclinical program and other research and development activities; |
| The scope, rate of progress and cost of any clinical trials we commence; |
| The cost of filing, prosecuting, defending and enforcing patent claims and other intellectual property rights; |
| Clinical trial results; |
| The terms and timing of any collaborative, licensing and other arrangements that we may establish; |
| The cost and timing of regulatory approvals; |
| The cost of establishing clinical and commercial supplies of our product candidates and any products that we may develop; |
| The cost and timing of establishing sales, marketing and distribution capabilities; |
| The effect of competing technological and market developments; and |
| The effect of government regulation and insurance industry efforts to control healthcare costs through reimbursement policy and other cost management strategies. |
Failure to complete any stage of the development of our product candidates in a timely manner could have a material adverse effect on our operations, financial position and liquidity.
Critical Accounting Policies and Estimates
There have been no significant changes to our critical accounting policies since the beginning of this fiscal year. Our critical accounting policies are described in the Managements Discussion and Analysis of Financial Condition and Results of Operations section of our Annual Report on Form 10-K for the year ended December 31, 2014, which we filed with the SEC on March 30, 2015.
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, |
|||||||||||||||
2015 | 2014 | 2015 | 2014 | |||||||||||||
Net revenue |
$ | | $ | 12 | $ | 34 | $ | 41 | ||||||||
Research and development expenses |
(1,361 | ) | (1,183 | ) | (3,468 | ) | (2,659 | ) | ||||||||
General and administrative expenses |
(804 | ) | (850 | ) | (1,677 | ) | (1,693 | ) | ||||||||
Operating loss |
(2,165 | ) | (2,021 | ) | (5,111 | ) | (4,311 | ) | ||||||||
Net loss |
(2,166 | ) | (2,006 | ) | (5,111 | ) | (4,290 | ) | ||||||||
Net loss applicable to common stockholders |
$ | (2,190 | ) | $ | (3,219 | ) | $ | (5,320 | ) | $ | (7,258 | ) |
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Comparison of the Three and Six Months Ended June 30, 2015 and 2014
Revenue
To date, we have generated revenue through government grants. The following table summarizes our total net revenue for the periods indicated, in thousands:
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||||
2015 | 2014 | 2015 | 2014 | |||||||||||||
Net revenue |
$ | | $ | 12 | $ | 34 | $ | 41 | ||||||||
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|
|
|
|
|
|
No revenue was recognized for the three months ended June 30, 2015, compared with $12,000 for the three months ended June 30, 2014. The decrease of $12,000, or 100%, was due to the completion of work on the Companys outstanding government grant during the three months ended March 31, 2015.
Total net revenue was approximately $34,000 for the six months ended June 30, 2015, compared with $41,000 for the six months ended June 30, 2014. The decrease of $7,000, or 17%, was due to the completion of work on the Companys outstanding government grant during the three months ended March 31, 2015 as compared with the same period in the prior year.
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, |
|||||||||||||||
2015 | 2014 | 2015 | 2014 | |||||||||||||
Research and development expenses |
$ | 1,361 | $ | 1,183 | $ | 3,468 | $ | 2,659 | ||||||||
General and administrative expenses |
804 | 850 | 1,677 | 1,693 | ||||||||||||
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Total operating expenses |
$ | 2,165 | $ | 2,033 | $ | 5,145 | $ | 4,352 | ||||||||
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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. We expect research and development expenses to increase as we expand our discovery, preclinical and clinical activities.
Total research and development expenses were approximately $1,361,000 for the three months ended June 30, 2015, compared with $1,183,000 for the three months ended June 30, 2014. The increase of $178,000, or 15%, was primarily due to an increase of $181,000 in research and development expenses related to subject-related and trial-related fees for the Companys ongoing three clinical trials and an increase of $12,000 in employee stock-based compensation offset by a decrease of $15,000 in non-employee stock-based compensation related to the change in the fair value of options quarter over quarter.
Total research and development expenses were approximately $3,468,000 for the six months ended June 30, 2015, compared with $2,659,000 for the six months ended June 30, 2014. The increase of $809,000, or 30%, was primarily due to an increase of $847,000 in research and development expenses related to the ramp up in preclinical ocular toxicology studies, subject-related fees for the Companys ongoing three clinical trials, primarily Study 1402, and the one-time expense related to the fair value of common stock issued to Hapten in connection with the close of the Samcyprone license acquisition in February 2015 and an increase of $32,000 in employee stock-based compensation offset by a decrease of $70,000 in non-employee stock-based compensation related to the change in the fair value of options quarter over quarter.
General and Administrative Expenses
General and administrative expenses consist primarily of compensation-related costs for our employees dedicated to general and administrative activities, legal fees, audit and tax fees, consultants, professional services and general corporate expenses.
General and administrative expenses were approximately $804,000 for the three months ended June 30, 2015, compared with $850,000 for the three months ended June 30, 2014. The decrease of $46,000, or 5%, was primarily due to a decrease of $39,000 in general and administrative expenses due to a reduction in legal fees during the quarter and a decrease of $7,000 in employee stock-based compensation.
General and administrative expenses were approximately $1,677,000 for the six months ended June 30, 2015, compared with $1,693,000 for the six months ended June 30, 2014. The decrease of $16,000, or 1%, was primarily due to a decrease of $52,000 in employee stock-based compensation as compared with the prior year offset by an increase of $36,000 in general and administrative expenses related to the use of outside professional services as compared with prior year.
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Series A and Series A-1 Preferred Stock Dividends
The following table summarizes our Series A and Series A-1 Preferred Stock dividends for the periods indicated, in thousands:
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||||
2015 | 2014 | 2015 | 2014 | |||||||||||||
Series A and Series A-1 Preferred Stock dividends |
$ | 24 | $ | 1,213 | $ | 209 | $ | 2,968 | ||||||||
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Total Series A and Series A-1 Preferred Stock dividends were approximately $24,000 for the three months ended June 30, 2015, compared with $1,213,000 for the three months ended June 30, 2014. The decrease of $1,189,000, or 98%, was primarily due to a decrease in the Companys closing common stock price on the dividend payment dates and the number of preferred shares earning dividends each quarter.
Total Series A and Series A-1 Preferred Stock dividends were approximately $209,000 for the six months ended June 30, 2015, compared with $2,968,000 for the six months ended June 30, 2014. The decrease of $2,759,000, or 93%, was primarily due to a decrease in the Companys closing common stock price on the dividend payment dates and the number of preferred shares earning dividends each quarter.
No shares of the Series A and Series A-1 Preferred Stock were outstanding at June 30, 2015. The rights and preferences of the Series A and Series A-1 Preferred Stock and the calculation of the dividend payable, are described further in Notes 5 and 6 to the financial statements.
Liquidity and Capital Resources
We had cash, cash equivalents and short-term investments of approximately $14.0 million as of June 30, 2015, compared with approximately $8.5 million in cash and cash equivalents as of December 31, 2014.
On June 2, 2015, the Company sold a total of 26,000,000 units at a price of $0.40 per unit in a public offering (the Offering). Each unit consists of one share of common stock, a 13-month overallotment purchase right to purchase one-half of one share of common stock at a price of $0.455 per full share of common stock (the Overallotment Purchase Rights) and a five-year warrant to purchase one-half of one share of common stock at a price of $0.52 per full share of common stock (the Warrants). As a result of the Offering, the Company received gross proceeds of approximately $10,400,000 and net proceeds of approximately $9,200,000 after placement agent fees and estimated Offering expenses, and assuming the Overallotment Purchase Rights and Warrants are not exercised.
During the six months ended June 30, 2015 the Company sold a total of 50,000 shares of common stock for net proceeds of approximately $64,000 to LPC subject to certain limitations and conditions set forth in the LPC Purchase Agreement. There were no sales made under the LPC Purchase Agreement during the three months ended June 30, 2015 and there have been no other sales under the LPC Purchase Agreement to date. Per the terms of the Offering, the Company cannot access the equity line until the expiration of the Overallotment Purchase Rights.
We believe that our existing cash, cash equivalents and short-term investments should be sufficient to fund our operations for at least the next twelve months. We have generated significant losses to date, have not generated any product revenue to date and may not generate product revenue in the foreseeable future, or ever. 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 agreements, in order to maintain our operations and meet our obligations to licensors. There is no guarantee that debt, additional equity or other funding will be available to the Company on acceptable terms, or at all. If we fail to obtain additional funding when needed, we may be forced to scale back or terminate operations or to seek to merge with or to be acquired by another company.
Net Cash Flow from Operating Activities
Net cash used in operating activities was $3,772,000 and $4,397,000 for the six months ended June 30, 2015 and 2014, respectively. The decrease in cash used in operating activities of $625,000 was primarily due to changes in working capital of $1,299,000 partially offset by an increase in net loss of $821,000 and an increase in non-cash items of $147,000.
Net Cash Flow from Investing Activities
Net cash used in investing activities for the six months ended June 30, 2015 was $8,039,000, of which $8,000,000 was attributable to the purchase of short-term investments and the remainder to fixed asset purchases. Net cash provided by investing activities for the six months ended June 30, 2014 was $2,941,000 and primarily related to the maturities of short-term investments, fixed asset purchases and proceeds from the disposal of fixed assets.
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Net Cash Flow from Financing Activities
Net cash provided by financing activities was $9,301,000 for the six months ended June 30, 2015 and was primarily due to net proceeds of $9,254,000 received from the issuance of shares of our common stock in connection with the Offering completed in June 2015 and from the issuance of shares of our common stock to LPC in connection with the equity facility. Net cash provided by financing activities was $1,977,000 for the six months ended June 30, 2014 and was primarily due to net proceeds of $1,947,000 for the issuance of shares of our common stock to LPC during the prior year period.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements or relationships.
ITEM 3. | QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
Not applicable.
ITEM 4. | CONTROLS AND PROCEDURES |
Disclosure Controls and Procedures
As of the end of the period covered by this quarterly report on Form 10-Q, Dr. Geert Cauwenbergh, our Chief Executive Officer and acting Chief Financial Officer (the Certifying Officer), evaluated the effectiveness of our disclosure controls and procedures. Disclosure controls and procedures are controls and procedures designed to reasonably assure that information required to be disclosed in our reports filed under the Securities Exchange Act of 1934 (the Exchange Act), such as this Form 10-Q, is recorded, processed, summarized and reported within the time periods specified in the SEC rules and forms. Disclosure controls and procedures are also designed to reasonably assure that such information is accumulated and communicated to our management, including the Certifying Officer, as appropriate to allow timely decisions regarding required disclosure. Based on these evaluations, the Certifying Officer has concluded, that, as of the end of the period covered by this quarterly report on Form 10-Q:
(a) | Our disclosure controls and procedures were effective to provide reasonable assurance that information required to be disclosed by us in the reports we file or submit under the Exchange Act was recorded, processed, summarized and reported within the time periods specified in the SECs rules and forms; and |
(b) | Our disclosure controls and procedures were effective to provide reasonable assurance that material information required to be disclosed by us in the reports we file or submit under the Exchange Act was accumulated and communicated to our management, including the Certifying Officer, as appropriate to allow timely decisions regarding required disclosure. |
Changes in Internal Control over Financial Reporting
There has not been any change in our internal control over financial reporting that occurred during the quarterly period ended June 30, 2015 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
ITEM 1. | LEGAL PROCEEDINGS |
None.
ITEM 1A. | RISK FACTORS |
You should consider the Risk Factors included under Item 1A. of our Annual Report on Form 10-K for the year ended December 31, 2014 filed with the SEC on March 30, 2015.
We may not be able to regain compliance with the continued listing requirements of The Nasdaq Capital Market.
On May 7, 2015, we received written notice (the Notification Letter) from the Nasdaq Stock Market (Nasdaq) notifying us that we are not in compliance with the minimum bid price requirements set forth in Nasdaq Listing Rule 5550(a)(2) for 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, we no longer meet the minimum bid price requirement.
The Notification Letter does not impact our listing on The Nasdaq Capital Market at this time. The Notification Letter states that we have 180 calendar days, or until November 3, 2015, to regain compliance with Nasdaq Listing Rule 5550(a)(2). To regain compliance, the bid price of our common stock must have a closing bid price of at least $1.00 per share for a minimum of 10 consecutive business days at any time prior to November 3, 2015. In the event that we do not regain compliance by November 3, 2015, we may be eligible for additional time to reach compliance with the minimum bid price requirement. However, if we fail to regain compliance with the minimum bid price listing requirement or fail to maintain compliance with all other applicable continued listing requirements and Nasdaq determines to delist our common stock, the delisting could adversely impact us by, among other things, reducing the liquidity and market price of our common stock; reducing the number of investors willing to hold or acquire our common stock; limiting our ability to issue additional securities in the future; and limiting our ability to fund our operations.
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ITEM 2. | UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS |
None.
ITEM 3. | DEFAULTS UPON SENIOR SECURITIES |
None.
ITEM 4. | MINE SAFETY DISCLOSURES |
Not applicable.
ITEM 5. | OTHER INFORMATION |
None.
ITEM 6. | EXHIBITS |
EXHIBIT INDEX
Incorporated by Reference Herein | ||||||
Exhibit |
Description | Form | Date | |||
4.1 | Form of Overallotment Common Stock Purchase Right | Registration Statement on Form S-1/A (File No. 333-203389) | May 21, 2015 | |||
4.2 | Form of Common Stock Purchase Warrant | Registration Statement on Form S-1/A (File No. 333-203389) | May 21, 2015 | |||
10.1 | Letter engagement agreement between the Company and H.C. Wainwright & Co., LLC, dated February 25, 2015 | Registration Statement on Form S-1/A (File No. 333-203389) | May 21, 2015 | |||
10.2 | Amendment to February 25, 2015 letter engagement agreement between the Company and H.C. Wainwright & Co., LLC, dated April 20, 2015 | Registration Statement on Form S-1/A (File No. 333-203389) | May 21, 2015 | |||
10.3 | Amendment to February 25, 2015 letter engagement agreement between the Company and H.C. Wainwright & Co., LLC, dated May 19, 2015 | Registration Statement on Form S-1/A (File No. 333-203389) | May 21, 2015 | |||
10.4 | Form of RXi Pharmaceuticals Corporation Securities Purchase Agreement | Registration Statement on Form S-1/A (File No. 333-203389) | May 21, 2015 | |||
31.1 | Sarbanes-Oxley Act Section 302 Certification of Chief Executive Officer and Chief Financial Officer.* | |||||
32.1 | Sarbanes-Oxley Act Section 906 Certification of Chief Executive Officer and Chief Financial Officer.* | |||||
101 | The following financial information from the Quarterly Report on Form 10-Q of RXi Pharmaceuticals Corporation for the quarter ended June 30, 2015, formatted in XBRL (eXtensible Business Reporting Language): (1) Condensed Balance Sheets as of June 30, 2015 and December 31, 2014; (2) Condensed Statements of Operations for the three and six months ended June 30, 2015 and 2014; (3) Condensed Statements of Cash Flows for the six months ended June 30, 2015 and 2014; and (4) Notes to Condensed Financial Statements (Unaudited).* |
* | Filed herewith. |
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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 (Registrant) | ||
By: | /s/ Geert Cauwenbergh | |
Geert Cauwenbergh, Dr. Med. Sc. | ||
President, Chief Executive Officer and acting Chief Financial Officer | ||
Date: August 12, 2015 |
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