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): August 14, 2014
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 |
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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)
Registrant’s 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 August 14, 2014, RXi Pharmaceuticals Corporation reported its results of operations for the quarter ended June 30, 2014. A copy of the press
release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
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 August 14, 2014. |
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2
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: August 14, 2014 |
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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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Chief Executive Officer |
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Exhibit 99.1
August 14, 2014
RXi Pharmaceuticals Reports Financial Results
for the Second Quarter of 2014
MARLBOROUGH, Mass./PRNewswire/ — RXi Pharmaceuticals Corporation (NASDAQ: RXII), a biotechnology company focused on discovering, developing and
commercializing innovative therapies addressing major unmet medical needs using RNA-targeted technologies, today reported its financial results for the quarter ended June 30, 2014, and provided a business update.
“Despite the general market down-turn in sentiment about biotech values, RXi Pharmaceuticals has continued to grow value in line with its promises to
shareholders,” said Dr. Geert Cauwenbergh, President and CEO of the Company. He added that, “We expect the company to continue to add data in the coming months that should add value to the unique IP position that we have in the RNAi
space.”
Second Quarter 2014 and Recent Corporate Highlights
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Entered into a Purchase Agreement with Lincoln Park Capital, LLC: The Company announced in April 2014 that the Company had entered into a purchase agreement with Lincoln Park Capital Fund, LLC (“LPC”),
a Chicago-based institutional investor, whereby LPC is committed to purchase up to an aggregate of $20 million of shares of the Company’s common stock. Upon execution, LPC purchased 500,000 shares of common stock at $4.00 per share, for an
initial investment of $2 million; the Company also issued 100,000 shares to LPC as a commitment fee for the facility. Upon the filing of the first investigational drug application for an ophthalmologic project with the U.S. Food and Drug
Administration, LPC will make an additional $1 million share purchase at prevailing market prices of the Company’s common stock. In addition, at the sole discretion of the Company, we may sell up to $17 million worth of common stock to LPC over
the 30-month term of the agreement. The funds, in part, will serve to advance research and development activities for the Company’s ophthalmological pre-clinical drug pipeline. |
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Announced the Initiation of a Phase 2 Keloid Study: The Company announced in April 2014 that the first patient in the Company’s Phase 2a study (RXI-109-1401) was enrolled for the prevention of keloid
recurrence. In this study, patients with two keloids of similar size and location are selected for keloidectomy. After this procedure, the lesions are closed and one is treated with RXI-109, and the other is treated with placebo. Patients will be
followed for several months after the end of treatment. |
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Positive Results with RXI-109 in the Eyes of Cynomolgus Monkeys as Part of a Dose-Range Finding Study: The Company announced results from the
assessment of connective tissue growth |
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factor (CTGF) protein levels following intravitreal injection of RXI-109 in the eyes of cynomolgus monkeys as part of a dose-range finding study. Intravitreal administration of RXI-109 resulted
in a reduction of CTGF protein levels in a dose-dependent manner in the retina, as well as in cornea tissue. IND-supporting toxicity testing of RXI-109 in the eye is slated to begin soon. |
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Granted U.S. Notice of Allowance Covering Self-Delivering (sd-rxRNA®) Technology Platform: The Company received a Notice of Allowance from the United
States Patent and Trademark Office in May 2014 on a patent covering our novel, self-delivering RNAi platform (sd-rxRNA). The patent titled “Reduced Size Self-Delivering RNAi Compounds” broadly covers both the composition and methods of use
of our self-delivering platform technology. The patent, once issued, will be scheduled to expire in 2029. |
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Appointment of Peter Campochiaro, M.D. to the Company’s Scientific Advisory Board: Dr. Peter Campochiaro joined the Company’s Scientific Advisory Board in July 2014. Dr. Campochiaro is the
George S. and Dolores Dore Eccles Professor of Ophthalmology and Neuroscience in the Johns Hopkins University School of Medicine. He is a prominent researcher, clinician and educator in the field of ophthalmology and sees patients at the Wilmer Eye
Institute at Johns Hopkins. |
Financial Highlights
Cash and Cash Equivalents
At June 30, 2014,
the Company had cash and cash equivalents of approximately $11.9 million, compared to $14.4 million cash, cash equivalents and short-term investments at December 31, 2013.
Net Loss
Net loss for the three months ended
June 30, 2014 was $2.0 million, including $0.5 million in non-cash share-based compensation expense, compared with a net loss of $2.0 million, including $0.4 million in non-cash share-based compensation expense, for the three months ended
June 30, 2013.
Net loss for the six months ended June 30, 2014 was $4.3 million, including $0.9 million in non-cash share-based compensation
expense, compared to a net loss of $16.4 million, including $1.1 million in non-cash share-based compensation expense, for the six months ended June 30, 2013. The decrease in net loss of $12.1 million was primarily attributable to a one-time
charge of $12.3 million in the first quarter of 2013 related to the fair value of common shares issued to OPKO Health, Inc. (“OPKO”) for the purchase of substantially all of OPKO’s RNAi-related assets.
Net Loss Applicable to Common Stockholders
Net
loss applicable to common stockholders for the three months ended June 30, 2014 was $3.2 million compared to a net loss applicable to common stockholders of $4.4 million for the comparable period in 2013. The decrease in net loss applicable to
common stockholders of $1.2 million was primarily attributable to a decrease of $1.2 million in the fair value of dividends paid in additional preferred stock to the Company’s preferred shareholders.
Net loss applicable to common stockholders for the six months ended June 30, 2014 was $7.3 million compared to a net loss applicable to common
stockholders of $22.3 million for the comparable period in 2013. The decrease in net loss applicable to common stockholders of $15.0 million was primarily attributable to the aforementioned decrease in net loss as compared to prior year and a
decrease of $2.9 million in the fair value of dividends paid in additional preferred stock to the Company’s preferred shareholders.
Research and Development Expenses
Research and development expenses for the three months ended June 30, 2014 were $1.2 million, compared to $1.2 million for the three months ended
June 30, 2013 and were consistent year over year.
Research and development expenses for the six months ended June 30, 2014 were $2.7 million,
compared to $15.0 million for the six months ended June 30, 2013. The decrease of $12.3 million is primarily related to the one-time charge in the first quarter of 2013 related to the fair value of common shares issued to OPKO for the purchase
of substantially all of OPKO’s RNAi-related assets.
General and Administrative Expenses
General and administrative expenses for the three months ended June 30, 2014 were $0.9 million, compared to $1.0 million for the three months ended
June 30, 2013. The decrease of $0.1 million was due was primarily due to a decrease in printing fees related to our public filings and a decrease in legal fees in connection with the Company’s reverse split which was completed in July
2013.
General and administrative expenses for the six months ended June 30, 2014 were $1.7 million, compared to $1.7 million for the six months
ended June 30, 2013. General and administrative expenses were consistent year over year.
Preferred Stock Dividends
Preferred stock dividends were $1.2 million for the three months ended June 30, 2014, compared to $2.4 million for the comparable period in 2013. The
decrease of $1.2 million is due to due changes in the Company’s closing common stock price on the dividend payment dates and the number of preferred shares earning dividends each quarter.
Preferred stock dividends were $3.0 million for the six months ended June 30, 2014, compared to $5.9 million for the comparable period in 2013. The
decrease of $2.9 million is due to due changes in the Company’s closing common stock price on the dividend payment dates and the number of preferred shares earning dividends each quarter.
About RXi Pharmaceuticals Corporation
RXi
Pharmaceuticals Corporation (NASDAQ: RXII) is a biotechnology company focused on discovering, developing and commercializing innovative therapies based on its proprietary, self-delivering RNAi
(sd-rxRNA®) platform. Therapeutics that use RNA interference, or “RNAi,” have great promise because of their ability to down-regulate the expression of specific genes that may be
over-expressed in disease conditions. Building on the pioneering work of scientific founder and Nobel Laureate Dr. Craig Mello, a member of the Company’s Scientific Advisory Board, RXi’s first RNAi product candidate, RXI-109, entered
into human clinical trials in June 2012 and is currently being evaluated in Phase 2 clinical trials to reduce dermal scarring (fibrosis). RXI-109 is also being evaluated in pre-clinical studies for retinal scarring. RXI-109 targets connective tissue
growth factor (CTGF), a key
player in development of dermal scarring, retinal scarring and fibrosis. RXi’s sd-rxRNA oligonucleotides are designed for therapeutic use and have
drug-like properties, such as high potency, target specificity, serum stability, reduced immune response activation, and efficient cellular uptake. These hybrid oligonucleotide molecules combine the beneficial properties of conventional RNAi and
antisense technologies. This allows sd-rxRNAs to achieve efficient cellular uptake and potent, long-lasting intracellular activity. For more information, please visit 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. Forward-looking statements can be identified by words such as: “intend,” “believe,” “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 and our other product candidates;
the timing and future success of our clinical trials with RXI-109; our expectation that we will complete our Phase 2 clinical trials for RXI-109 within anticipated time periods and budgets; and statements about other future expectations.
Forward-looking statements are neither historical facts nor assurances of future performance. Instead they 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 RXI-109 may not be successful in
evaluating the continued safety and tolerability of RXI-109 or providing preliminary evidence of the reduction of formation of surgical scars; the successful and timely completion of clinical studies; uncertainties regarding the regulatory process;
the availability of funds and resources to pursue our research and development projects, including our clinical trials with RXI-109; and those identified under “Risk Factors” in the Company’s most recently filed Annual Report on Form
10-K, Quarterly Report on Form 10-Q and in other filings the Company periodically makes with the SEC. 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 press release.
Contact
RXi Pharmaceuticals Corporation
Tamara McGrillen
508-929-3646
tmcgrillen@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
June 30,
2014 |
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For the Three
Months
Ended
June 30,
2013 |
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For the Six
Months
Ended
June 30,
2014 |
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For the Six
Months
Ended
June 30,
2013 |
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| Total revenues |
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$ |
12 |
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$ |
225 |
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$ |
41 |
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$ |
278 |
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| Research and development expenses |
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1,183 |
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1,213 |
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2,659 |
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14,985 |
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| General and administrative expenses |
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850 |
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977 |
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1,693 |
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1,652 |
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| Operating loss |
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(2,021 |
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(1,965 |
) |
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(4,311 |
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(16,359 |
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| Interest income, net |
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5 |
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4 |
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11 |
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4 |
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| Other income (expense), net |
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10 |
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— |
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10 |
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(3 |
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| Net loss |
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(2,006 |
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(1,961 |
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(4,290 |
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(16,358 |
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| Series A and Series A-1 convertible preferred stock dividends |
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(1,213 |
) |
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(2,399 |
) |
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(2,968 |
) |
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(5,946 |
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| Net loss applicable to common stockholders |
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$ |
(3,219 |
) |
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$ |
(4,360 |
) |
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$ |
(7,258 |
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$ |
(22,304 |
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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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$ |
(0.23 |
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$ |
(0.39 |
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$ |
(0.54 |
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$ |
(2.52 |
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| Weighted average common shares outstanding: |
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| Basic and diluted |
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14,015,451 |
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11,168,144 |
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13,319,634 |
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8,845,026 |
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RXi PHARMACEUTICALS CORPORATION
CONDENSED BALANCE SHEETS
(Amounts in thousands)
(Unaudited)
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June 30,
2014 |
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December 31,
2013 |
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| ASSETS |
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| Current assets: |
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| Cash and cash equivalents |
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$ |
11,911 |
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$ |
11,390 |
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| Restricted cash |
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50 |
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50 |
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| Short-term investments |
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— |
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3,000 |
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| Prepaid expenses and other current assets |
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367 |
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303 |
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| Total current assets |
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12,328 |
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14,743 |
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| Equipment and furnishings, net |
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204 |
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177 |
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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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$ |
12,550 |
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$ |
14,938 |
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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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$ |
293 |
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$ |
163 |
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| Accrued expenses and other current liabilities |
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682 |
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1,795 |
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| Deferred revenue |
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78 |
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118 |
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| Total current liabilities |
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1,053 |
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2,076 |
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| Total Series A convertible preferred stock |
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4,935 |
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7,920 |
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| Total stockholders’ equity |
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6,562 |
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4,942 |
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| Total liabilities, Series A convertible preferred stock and stockholders’ equity |
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$ |
12,550 |
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$ |
14,938 |
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