UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT
TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): May 13, 2015
RXi PHARMACEUTICALS CORPORATION
(Exact name of registrant as specified in its charter)
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Delaware |
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000-54910 |
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45-3215903 |
(State or other jurisdiction of
incorporation or organization) |
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(Commission
File Number) |
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(I.R.S. Employer
Identification No.) |
257 Simarano Drive, Suite 101
Marlborough, Massachusetts 01752
(Address of Principal Executive Offices) (Zip Code)
Registrants telephone number, including area code: (508) 767-3861
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any
of the following provisions (see General Instruction A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 2.02 |
Results of Operations and Financial Condition. |
On May 13, 2015, RXi Pharmaceuticals Corporation
reported its results of operations for the quarter ended March 31, 2015. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K (the Report).
The information in this Item 2.02 and attached as Exhibit 99.1 to this Report will not be treated as filed for the purposes of
Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or otherwise subject to the liabilities of that section. This information will not be incorporated by reference into any filing under the
Securities Act of 1933, as amended, or into another filing under the Exchange Act, unless that filing expressly incorporates this information by reference.
Item 9.01 |
Financial Statements and Exhibits. |
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99.1 |
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Press Release dated May 13, 2015. |
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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 hereunto duly authorized.
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RXi PHARMACEUTICALS CORPORATION |
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Date: May 13, 2015 |
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By: |
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/s/ Geert Cauwenbergh |
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Geert Cauwenbergh, Dr. Med. Sc. |
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President, Chief Executive Officer and acting Chief Financial Officer |
Exhibit 99.1
May 13, 2015
RXi Pharmaceuticals Reports First Quarter
2015 Financial Results and Business Highlights
MARLBOROUGH, Mass./PRNewswire/May 13, 2015 RXi Pharmaceuticals Corporation (NASDAQ: RXII), a biotechnology company focused on discovering and
developing innovative therapeutics primarily in the areas of dermatology and ophthalmology, today reported its financial results for the quarter ended March 31, 2015, and provided a business update.
RXi has continued its efforts to increase shareholder value with key developments during this first quarter, said Dr. Geert Cauwenbergh,
President and CEO of RXi Pharmaceuticals. The exclusive license of our sd-rxRNA® technology to MirImmune for ex vivo cell-based cancer immunotherapies not only provides the
potential for long-term financial return, it also highlights the potential therapeutic development opportunities for our propriety platform. Furthermore, the completion of the global license agreement for Samcyprone now allows us to drive this
program forward and further broadens our clinical pipeline. Lastly, as communicated in our year-end earnings call, top-line results from our first Phase 2a trial three months after scar revision surgery have provided clear guidance for our ongoing
and future clinical development and strategy with RXI-109. We anticipate sharing additional updates later this year for both our dermal and ocular programs.
The Company will host a conference call today at 4:30 p.m. EDT to discuss financial results and provide an update on the Company. The webcast link will be
available under the Investors section of the Companys website, www.rxipharma.com. The event may also be accessed by dialing toll-free in the United States and Canada: +1 888-669-0684. International participants may access
the event by dialing: +1 862-225-5361. An archive of the webcast will be available on the Companys website approximately two hours after the presentation.
Financial Highlights
Preferred Shares
At March 31, 2015, there were 3,085 and 21 shares of Series A Preferred Stock and Series A-1 Preferred Stock outstanding, respectively, or
approximately 19% ownership on a fully-diluted basis. Subsequent to the quarter ended March 31, 2015, 2,026 shares of Series A Preferred Stock were converted into shares of the Companys common stock. As a result of these conversions, as of May
13, 2015 the Company had 1,059 and 21 shares of Series A Preferred Stock and Series A-1 Preferred Stock outstanding, respectively, or approximately 7% ownership on a fully-diluted basis.
The Company had 36,160,133 shares of common stock outstanding as of May 13, 2015 and the number of common stock underlying the Series A Preferred Stock and
Series A-1 Preferred Stock, as of the same date, totaled approximately 2.6 million shares.
Cash Position
At March 31, 2015, the Company had cash and cash equivalents of approximately $6.6 million, compared with cash and cash equivalents of $8.5 million
at December 31, 2014. We believe that our existing cash and cash equivalents and the potential proceeds available under our equity facility with Lincoln Park Capital should be sufficient to fund our operations for at least one year.
Research and Development Expenses
Research and
development expenses for the quarter ended March 31, 2015 were $2.1 million, compared with $1.5 million for the quarter ended March 31, 2014. Research and development expenses increased from the prior quarter primarily due to toxicology
studies required for the Companys ophthalmology IND, subject-related fees for the Companys three ongoing Phase 2a clinical trials and expenses related to the close of the Samcyprone license agreement in February 2015.
General and Administrative Expenses
General and administrative expenses for the quarter ended March 31, 2015 were $0.9 million, compared with $0.8 million for the quarter ended
March 31, 2014. General and administrative expenses increased primarily due to legal fees required during the quarter as compared with the same period in the prior year.
Net Loss Applicable to Common Stockholders
Net
loss attributable to common stockholders for the quarter ended March 31, 2015 was $3.1 million, compared with $4.0 million for the same period in 2014. The decrease in net loss applicable to common stockholders for the quarter was primarily
attributable 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.
First Quarter 2015 and Recent Corporate Highlights
Reported Positive Advancements within our Dermatology Franchise
Early top line results from our first Phase 2a study, RXI-109-1301, have shaped the Companys ongoing and future clinical development strategy. Based on
three month data, the Company has shown that treatment with RXI-109 has a clinical effect in the target population. In addition, initiating treatment with RXI-109 two weeks after scar revision surgery, during the proliferation phase of the wound
healing process, is beneficial as compared to initiating treatment immediately after surgery (during the inflammation phase). Based on these observations, the Company is implementing an optimized dosing regimen in study RXI-109-1402. In study
RXI-109-1402, RXI-109 is being evaluated to reduce recurrence of hypertrophic scars after scar revision surgery. In this study, enrollment is more than 50% complete.
Enrollment is complete and data collection is ongoing for the Companys Phase 2a clinical trial, RXI-109-1401, which is evaluating RXI-109 to reduce
recurrence of keloids after scar revision surgery.
The Company completed the global license agreement for Samcyprone. This propriety topical
formulation of diphenylcyclopropenone (DPCP) is being evaluated for the treatment of warts, alopecia areata and cutaneous metastases of malignant melanoma. DPCP is an immunomodulating agent that works by eliciting a T-cell response. While the
drug DPCP has been used for decades, it is expected that Samcyprone will result in a better safety profile, a more consistent drug product and equivalent efficacy at lower doses. In April of this year, the U.S. Food and Drug Administration
(FDA) granted Orphan Drug Designation to RXi for Samcyprone for the treatment of Malignant Melanoma Stage IIb to IV. A number of patients with Stage IIb to IV malignant melanoma develop cutaneous metastases. Samcyprone is being developed
for treatment of these metastases.
The Company entered into collaborations with Dr. James Krueger of The Rockefeller University for the study of the
effects of Samcyprone on the changes in gene expression profiles influenced by DPCP in patients with cutaneous metastases of solid tumors and with Dr. Maria Hordinsky of the University of Minnesota and the National Alopecia Areata
Foundation for the study of Samcyprone in the treatment of alopecia areata.
The Company presented new data at the 74th Annual Meeting of the Society for Investigative Dermatology on the Companys proprietary self-delivering RNAi (sd-rxRNA®) compounds
developed to target tyrosinase (TYR) and collagenase (MMP1). sd-rxRNA compounds developed to target TYR, lead to a visible reduction of pigmentation in melanocytes in a 3-dimensional tissue culture model of human epidermis. Results from experiments
in this model show that sd-rxRNA compounds targeting TYR are at least one hundred times more potent than kojic acid, a well-characterized skin lightening agent. sd-rxRNA compounds developed to target MMP1 resulted in a reduction in MMP1 mRNA levels
that correspond to a similar reduction in MMP1 enzyme activity in cell culture in vitro. In addition, silencing of MMP1 expression in an in vitro scratch assay resulted in reduced migration of A549 cells, a clinically relevant
non-small cell lung cancer cell line. Reduced migration in a scratch assay may indicate a reduction in the invasive nature of the cancer cell due to MMP1 reduction as a result of sd-rxRNA treatment.
Exclusive Licensing Agreement
The Company entered into an exclusive license agreement with MirImmune LLC for use of the Companys novel and proprietary sd-rxRNA technology in
developing innovative ex vivo cell-based cancer immunotherapies. MirImmune will develop ex vivo cell-based therapeutics utilizing RXis sd-rxRNA technology to target immune inhibitory pathways, which are in part responsible for
limiting the efficacy of cancer immunotherapeutics. As consideration for the license, RXi will receive an annual licensing fee, clinical milestone payments, sublicensing income and single digit royalties. Pending MirImmunes achievement of a
few gating milestones, RXi will also have the right to acquire a double-digit equity stake in MirImmune.
Intellectual Property
The Company was granted a patent by the United States Patent and Trademark Office for the delivery of double stranded siRNAs (21 to 23 nucleotides in length)
across the blood-retina barrier (e.g., topical or systemic delivery) for the treatment of wet age-related macular degeneration or diabetic retinopathy. The patent, which was part of the RNAi assets acquired from OPKO Health, Inc., is scheduled to
expire in 2023.
About RXi Pharmaceuticals Corporation
RXi Pharmaceuticals Corporation (NASDAQ: RXII) is a biotechnology company focused on discovering and developing innovative therapeutics primarily in the areas
of dermatology and ophthalmology that address high-unmet medical needs. Our discovery and clinical development programs are based on siRNA technology as well as immunotherapy agents. These compounds include, but are not limited to, our
proprietary, self-delivering RNAi (sd-rxRNA®) compounds for the treatment of dermal and retinal scarring. It also includes an immunomodulator, Samcyprone, a proprietary topical
formulation of diphenylcyclopropenone (DPCP), for the treatment of such disorders as alopecia areata, warts, and cutaneous metastases of melanoma.
RXis robust pipeline, coupled with an extensive patent portfolio, provides for product and business development opportunities across a broad spectrum.
We are committed to being a partner of choice for academia, small companies, and large multinationals. We welcome ideas and proposals for strategic alliances, including in- and out-licensing opportunities, to advance and further develop strategic
areas of interest. Additional information may be found on the Companys website, www.rxipharma.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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 about expectations and development plans of RXis product candidates and
partnerships involve significant risks and uncertainties, including the following: risks that we may not be able to successfully develop and commercialize our product candidates; risks that product development and clinical studies may be delayed,
not proceed as planned and/or be subject to significant cost over-runs; risks related to the development and commercialization of products by competitors; risks related to our ability to control the timing and terms of collaborations with third
parties; and risks that other companies or organizations may assert patent rights preventing us from developing or commercializing our product candidates. Additional risks are detailed in our most recent Annual Report on Form 10-K and
subsequent Quarterly Reports on Form 10-Q under the caption Risk Factors. Readers are urged to review these risk factors and to not act in reliance on any forward-looking statements, as actual results may differ from those
contemplated by our forward-looking statements. RXi does not undertake to update forward-looking statements to reflect a change in its views, events or circumstances that occur after the date of this release.
Contact
RXi
Pharmaceuticals Corporation
Tamara McGrillen
508-929-3646
tmgrillen@rxipharma.com
RXi PHARMACEUTICALS CORPORATION
CONDENSED STATEMENTS OF OPERATIONS
(Amounts in
thousands, except share and per share data)
(Unaudited)
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For the Three Months Ended March 31, 2015 |
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For the Three Months Ended March 31, 2014 |
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Total revenues |
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$ |
34 |
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$ |
29 |
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Research and development expenses |
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2,107 |
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1,476 |
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General and administrative expenses |
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873 |
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843 |
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Loss from operations |
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(2,946 |
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(2,290 |
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Interest income, net |
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1 |
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6 |
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Net loss |
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(2,945 |
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(2,284 |
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Series A and Series A-1 convertible preferred stock dividends |
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(185 |
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(1,755 |
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Net loss applicable to common stockholders |
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$ |
(3,130 |
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$ |
(4,039 |
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Net loss per common share applicable to common stockholders: |
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Basic and diluted loss per share |
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$ |
(0.13 |
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$ |
(0.32 |
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Weighted average common shares outstanding: |
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Basic and diluted |
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23,763,486 |
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12,616,086 |
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RXi PHARMACEUTICALS CORPORATION
CONDENSED BALANCE SHEETS
(Amounts in thousands)
(Unaudited)
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March 31, 2015 |
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December 31, 2014 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
6,580 |
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$ |
8,496 |
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Restricted cash |
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50 |
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50 |
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Prepaid expenses and other current assets |
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351 |
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442 |
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Total current assets |
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6,981 |
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8,988 |
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Equipment and furnishings, net |
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170 |
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183 |
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Other assets |
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18 |
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18 |
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Total assets |
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$ |
7,169 |
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$ |
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 |
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$ |
459 |
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$ |
285 |
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Accrued expenses and other current liabilities |
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1,097 |
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1,002 |
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Deferred revenue |
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47 |
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Total current liabilities |
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1,556 |
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1,334 |
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Total convertible preferred stock |
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3,085 |
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5,110 |
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Total stockholders equity |
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2,528 |
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2,745 |
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Total liabilities, convertible preferred stock and stockholders equity |
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$ |
7,169 |
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$ |
9,189 |
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