SELLAS Life Sciences Group, Inc. - Quarter Report: 2009 September (Form 10-Q)
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)
þ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2009
OR
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the transition period from
to
Commission File number 001-33958
RXi Pharmaceuticals Corporation
(Exact name of registrant as specified in its charter)
Delaware | 20-8099512 | |
(State of incorporation) | (I.R.S. Employer Identification No.) |
60 Prescott Street, Worcester, MA 01605
(Address of principal executive office) (Zip code)
(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 þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on it
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 o No o
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 o | Accelerated filer o | Non-accelerated filer o | Smaller reporting company þ | |||
(Do not check if a smaller reporting company) |
Indicate by checkmark whether the Registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act).
Yes o No þ
As of November 13, 2009, RXi Pharmaceuticals Corporation had 16,207,625 shares of common stock,
$0.0001 par value, outstanding.
RXi PHARMACEUTICALS CORPORATION
FORM 10-Q QUARTER ENDED SEPTEMBER 30, 2009
FORM 10-Q QUARTER ENDED SEPTEMBER 30, 2009
INDEX
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PART I
ITEM 1. FINANCIAL STATEMENTS
RXi PHARMACEUTICALS CORPORATION
(A Development Stage Company)
(A Development Stage Company)
CONDENSED BALANCE SHEETS
(Amounts in thousands, except share and per share data)
(Unaudited)
(Amounts in thousands, except share and per share data)
(Unaudited)
September 30, | December 31, | |||||||
2009 | 2008 | |||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 8,988 | $ | 9,856 | ||||
Prepaid expenses and other current assets |
245 | 73 | ||||||
Total current assets |
9,233 | 9,929 | ||||||
Equipment and furnishings, net |
472 | 414 | ||||||
Deposits |
16 | 16 | ||||||
Total assets |
$ | 9,721 | $ | 10,359 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 534 | $ | 394 | ||||
Accrued expenses and other current liabilities |
1,477 | 976 | ||||||
Current maturities of capital lease obligations |
24 | 17 | ||||||
Warrants potentially settled in cash |
1,867 | | ||||||
Total current liabilities |
3,902 | 1,387 | ||||||
Capital lease obligations, net of current maturities |
80 | 4 | ||||||
Total liabilities |
3,982 | 1,391 | ||||||
Commitments and contingencies (Note 4) |
||||||||
Stockholders equity: |
||||||||
Preferred stock, $0.0001 par value; 5,000,000
shares authorized; no shares issued and
outstanding |
| | ||||||
Common stock, $0.0001 par value; 50,000,000
shares authorized; 16,207,625 and 13,763,231
shares issued and outstanding at September 30,
2009 and December 31, 2008, respectively |
2 | 1 | ||||||
Additional paid-in capital |
43,339 | 34,330 | ||||||
Deficit accumulated during the developmental stage |
(37,602 | ) | (25,363 | ) | ||||
Total stockholders equity |
5,739 | 8,968 | ||||||
Total liabilities and stockholders equity |
$ | 9,721 | $ | 10,359 | ||||
The accompanying notes are an integral part of these financial statements.
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RXi PHARMACEUTICALS CORPORATION
(A Development Stage Company)
(A Development Stage Company)
CONDENSED STATEMENTS OF EXPENSES
(Amounts in thousands, except share and per share data)
(Unaudited)
(Amounts in thousands, except share and per share data)
(Unaudited)
Period from | ||||||||||||||||||||
January 1, 2003 | ||||||||||||||||||||
For the Three | For the Three | For the Nine | For the Nine | (Date of | ||||||||||||||||
Months Ended | Months Ended | Months Ended | Months Ended | Inception) to | ||||||||||||||||
September 30, | September 30, | September 30, | September 30, | September 30, | ||||||||||||||||
2009 | 2008 | 2009 | 2008 | 2009 | ||||||||||||||||
Expenses: |
||||||||||||||||||||
Research and development expense |
$ | 1,945 | $ | 1,033 | $ | 4,956 | $ | 3,222 | $ | 18,865 | ||||||||||
Research and development
employee stock-based
compensation expense |
219 | 84 | 631 | 197 | 1,087 | |||||||||||||||
Research and development
non-employee stock-based
compensation expense |
(73 | ) | 83 | 946 | 1,635 | 4,969 | ||||||||||||||
Fair value of common stock in
exchange for licensing rights |
| | | | 3,954 | |||||||||||||||
Total research and development
expenses |
2,091 | 1,200 | 6,533 | 5,054 | 28,875 | |||||||||||||||
General and administrative |
1,385 | 1,124 | 4,113 | 3,488 | 14,247 | |||||||||||||||
General and administrative
employee stock-based
compensation |
506 | 542 | 1,475 | 1,391 | 4,281 | |||||||||||||||
Common stock warrants issued
for general and administrative
expenses |
| 598 | 826 | 598 | 1,576 | |||||||||||||||
Change in fair value of common
stock warrants issued |
(996 | ) | | (996 | ) | | (996 | ) | ||||||||||||
Fair value of common stock
issued in exchange for general
and administrative expenses |
| | 281 | | 281 | |||||||||||||||
Total general and
administrative expenses |
895 | 2,264 | 5,699 | 5,477 | 19,389 | |||||||||||||||
Operating loss |
(2,986 | ) | (3,464 | ) | (12,232 | ) | (10,531 | ) | (48,264 | ) | ||||||||||
Interest income (expense) |
(1 | ) | 56 | (3 | ) | 159 | 625 | |||||||||||||
Other income (expense) |
| | (4 | ) | | (4 | ) | |||||||||||||
Net loss |
$ | (2,987 | ) | $ | (3,408 | ) | $ | (12,239 | ) | $ | (10,372 | ) | $ | (47,643 | ) | |||||
Net loss per common share: |
||||||||||||||||||||
Basic and diluted loss per share |
$ | (0.19 | ) | $ | (0.25 | ) | $ | (0.85 | ) | $ | (0.79 | ) | N/A | |||||||
Weighted average common shares
outstanding: |
||||||||||||||||||||
Basic and diluted |
15,327,482 | 13,757,731 | 14,319,262 | 13,064,396 | N/A | |||||||||||||||
The accompanying notes are an integral part of these financial statements
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RXi PHARMACEUTICALS CORPORATION
(A Development Stage Company)
(A Development Stage Company)
CONDENSED STATEMENTS OF CASH FLOWS
(Amounts in thousands)
(Unaudited)
(Amounts in thousands)
(Unaudited)
Period from | ||||||||||||
January 1, 2003 | ||||||||||||
(Date of | ||||||||||||
For the Nine | For the Nine | Inception) | ||||||||||
Months Ended | Months Ended | through | ||||||||||
September 30, | September 30, | September 30, | ||||||||||
2009 | 2008 | 2009 | ||||||||||
Cash flows from operating activities: |
||||||||||||
Net loss |
$ | (12,239 | ) | $ | (10,372 | ) | $ | (47,643 | ) | |||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||||||
Depreciation and amortization expense |
122 | 93 | 289 | |||||||||
Loss on disposal of equipment |
4 | 8 | 12 | |||||||||
Non-cash rent expense |
| 29 | 29 | |||||||||
Accretion and receipt of bond discount |
| 150 | 35 | |||||||||
Non-cash share-based compensation |
3,052 | 3,223 | 10,339 | |||||||||
Fair value of common stock warrants issued in exchange for services |
826 | 598 | 1,576 | |||||||||
Fair value of common stock issued in exchange for services |
281 | | 281 | |||||||||
Change in fair value of common stock warrants issued |
(996 | ) | | (996 | ) | |||||||
Fair value of common stock issued in exchange for licensing rights |
| | 3,954 | |||||||||
Changes in assets and liabilities: |
||||||||||||
Prepaid expenses |
(172 | ) | (262 | ) | (245 | ) | ||||||
Accounts payable |
140 | 209 | 534 | |||||||||
Due to former parent |
| (207 | ) | (207 | ) | |||||||
Accrued expenses and other current liabilities |
501 | (163 | ) | 1,477 | ||||||||
Net cash used in operating activities |
(8,481 | ) | (6,694 | ) | (30,565 | ) | ||||||
Cash flows from investing activities: |
||||||||||||
Purchase of short-term investments |
| (19,785 | ) | (31,542 | ) | |||||||
Maturities of short-term investments |
| 20,530 | 31,507 | |||||||||
Cash paid for purchase of equipment and furnishings |
(82 | ) | (72 | ) | (580 | ) | ||||||
Disposal of equipment and furnishings |
(1 | ) | | (1 | ) | |||||||
Cash paid for lease deposit |
| 21 | (45 | ) | ||||||||
Net cash provided by (used in) investing activities |
(83 | ) | 694 | (661 | ) | |||||||
Cash flows from financing activities: |
||||||||||||
Net proceeds from issuance of common stock |
7,714 | 7,918 | 31,132 | |||||||||
Net proceeds from exercise of common stock options |
| | 356 | |||||||||
Repayments of capital lease obligations |
(18 | ) | (17 | ) | (40 | ) | ||||||
Cash advances from former parent company, net |
| | 8,766 | |||||||||
Net cash provided by (used in) financing activities |
7,696 | 7,901 | 40,214 | |||||||||
Net increase (decrease) in cash and cash equivalents |
(868 | ) | 1,901 | 8,988 | ||||||||
Cash and cash equivalents at the beginning of period |
9,856 | 1,763 | | |||||||||
Cash and cash equivalents at end of period |
$ | 8,988 | $ | 3,664 | $ | 8,988 | ||||||
Supplemental disclosure of cash flow information: |
||||||||||||
Cash received during the period for interest |
$ | 1 | $ | 358 | $ | 724 | ||||||
Cash paid during the period for interest |
$ | | $ | | $ | 7 | ||||||
Supplemental disclosure of non-cash investing and financing activities: |
||||||||||||
Settlement of corporate formation expenses in exchange for common stock |
$ | | $ | | $ | 978 | ||||||
Value of warrants issued in connection with common stock |
$ | 2,863 | $ | | $ | 2,863 | ||||||
Allocation of management expenses |
$ | | $ | | $ | 551 | ||||||
Equipment and furnishings exchanged for common stock |
$ | | $ | | $ | 48 | ||||||
Equipment and furnishings acquired through capital lease |
$ | 101 | $ | 43 | $ | 144 | ||||||
Non-cash lease deposit |
$ | | $ | | $ | 50 | ||||||
The accompanying notes are an integral part of these financial statements.
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1. Description of Business and Basis of Presentation
RXi Pharmaceuticals Corporation (RXi or the Company) began operations in January 2007 as a
biopharmaceutical company pursuing the development of proprietary therapeutics based on RNAi for
the treatment of human diseases. By utilizing the Companys
expertise in RNA interference (RNAi) and the RNAi
therapeutic platform the Company has established, the Company believes it will be able to
efficiently identify lead compounds and advance towards clinical development of commercially
marketable compounds, primarily in partnerships with pharmaceutical and larger biotech companies.
To date, RXis principal activities have consisted of conducting research and pre-clinical
development activities utilizing its RNAi therapeutic platform, acquiring key RNAi technologies and
patent rights through exclusive, co-exclusive and non-exclusive licenses, recruiting a RNAi-focused
management and scientific/clinical advisory team, capital raising activities and conducting
business development activities aimed at establishing development partnerships with pharmaceutical
and larger biotech companies. As the Company has not generated any revenues from inception through
September 30, 2009, the Company is considered a development-stage company for accounting purposes.
The Company expects to incur significant operating losses for the foreseeable future while it
advances its future product candidates from discovery through pre-clinical studies and clinical
trials and seeks regulatory approval and potential commercialization, even if the Company is
collaborating with pharmaceutical and larger biotech companies. The Company also expects general
and administrative costs to increase as it recruits additional management and administrative
personnel. The Company will need to generate significant revenues to achieve profitability and may
never do so.
In the future, the Company will be dependent on obtaining funding from third parties such as
proceeds from the sale of equity, funded research and development payments and payments under
partnership and collaborative agreements, to maintain its operations. There is no guarantee that
debt, additional equity or other funding will be available to the Company on acceptable terms, or
at all. If the Company fails to obtain additional funding when needed, it would be forced to scale
back or terminate its operations, or to seek to merge with or to be acquired by another company.
The accompanying condensed financial statements have been prepared in accordance with the
rules and regulations of the Securities and Exchange Commission (SEC) and should be read in
conjunction with the Companys financial statements and the notes thereto for the year ended
December 31, 2008 included in the Companys Annual Report on Form 10-K filed with the SEC on March
18, 2009. Certain information and footnote disclosures normally included in financial statements
prepared in accordance with United States generally accepted accounting principles, (U.S. GAAP)
have been condensed or omitted pursuant to such rules and regulations. The information presented as
of and for the three and nine month periods ended September 30, 2009 and 2008, as well as the
cumulative financial information for the period from January 1, 2003 (date of inception) through
September 30, 2009, is unaudited and has been prepared on the same basis as the audited financial
statements and includes all adjustments, consisting of only normal recurring adjustments, necessary
for the fair presentation of this information in all material respects. The results of any interim
period are not necessarily indicative of the results of operations to be expected for a full fiscal
year. There have been no material changes to the Companys significant accounting policies as
disclosed in the Companys Annual Report on Form 10-K for the year ended December 31, 2008.
Uses of estimates in preparation of financial statements
The preparation of financial statements in accordance with accounting principles generally
accepted in the United States of America 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.
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Derivative Financial Instruments
During the normal course of business, from time to time, the Company issues warrants and
options to vendors as consideration to perform services. It may also issue warrants as part of a
debt or equity financing. The Company does not enter into any derivative contracts for speculative
purposes.
The Company recognizes all derivatives as assets or liabilities measured at fair value with
changes in fair value of derivatives reflected as current period income or loss unless the
derivatives qualify for hedge accounting and are accounted for as such. During the nine months
ended September 30, 2009, the Company issued warrants to purchase 978,142 shares of common stock in
connection with an equity transaction. In accordance with Financial Accounting Standards Board
(FASB) Accounting Standards Codification (ASC) Topic 815-40, Derivatives and Hedging
Contracts in Entitys Own Stock (ASC 815-40), the value of these warrants is required to be
recorded as a liability, as the holders have an option to put the warrants back to the Company in
certain events, as defined.
2. Stock Based Compensation
The Company follows the provisions of the FASB ASC Topic 718, Compensation Stock
Compensation (ASC 718), ASC 718 requires the measurement and recognition of compensation expense
for all share-based payment awards made to employees, non-employee directors, and consultants,
including employee 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 vesting 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.
The Company is currently using the Black-Scholes option-pricing model to determine the fair
value of all its option grants. For options grants issued in the nine month period ended September
30, 2009 and 2008, the following assumptions were used:
2009 | 2008 | |||||||
Risk-free interest rate |
1.55% - 3.84% | 2.36% - 3.99 % | ||||||
Expected volatility |
116.72% - 122.93% | 101.8% - 103.24 % | ||||||
Expected lives (years) |
6 - 10 | 6 - 10 | ||||||
Expected dividend yield |
0.00 % | 0.00 % |
The weighted average fair value of options granted during the nine month period ended
September 30, 2009 and 2008 was $3.82 and $5.58 per share, respectively.
RXis expected common stock price volatility assumption is based upon the volatility of a
basket of comparable companies. The expected life assumptions for employee grants were based upon
the simplified method provided for under ASC 718-10, which averages the contractual term of RXis
options of ten years with the average vesting term of four years for an average of six years. The
expected life assumptions for non-employees were based upon the contractual term of the option. The
dividend yield assumption of zero is based upon the fact that RXi has never paid cash dividends and
presently has no intention of paying cash dividends. The risk-free interest rate used for each
grant was also based upon prevailing short-term interest rates. RXi has estimated an annualized
forfeiture rate of 4.0% for options granted to its employees, 2.1% for options granted to senior
management and no forfeiture rate for the directors. RXi will record additional expense if the
actual forfeitures are lower than estimated and will record a recovery of prior expense if the
actual forfeiture rates are higher than estimated.
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The following table summarizes stock option activity from January 1, 2009 through September 30,
2009:
Total Number | Weighted Average | |||||||
of Shares | Exercise Price | |||||||
Outstanding at January 1, 2009 |
2,223,452 | $ | 6.11 | |||||
Granted |
1,272,546 | 4.29 | ||||||
Exercised |
281 | 4.19 | ||||||
Cancelled |
171,057 | 4.90 | ||||||
Outstanding at September 30, 2009 |
3,324,660 | $ | 5.48 | |||||
Options exercisable at September 30, 2009 |
1,985,527 | $ | 5.45 | |||||
The aggregate intrinsic values of outstanding and exercisable options at September 30, 2009
were calculated based on the closing price of the Companys common stock on September 30, 2009 of
$2.45 per share less the exercise price of those shares. The total intrinsic value of outstanding
common stock options and exercisable common stock options for the nine months ended September 30,
2009 was zero for each.
3. Net Loss Per Share
The Company accounts for and discloses net loss per common share in accordance with FASB ASC
Topic 260 Earnings per Share. Basic net loss per common share is computed by dividing net loss
attributable to common stockholders by the weighted average number of common shares outstanding.
Diluted net loss per common share is computed by dividing net loss attributable to common
stockholders by the weighted average number of common shares that would have been outstanding
during the period assuming the issuance of common shares for all potential dilutive common shares
outstanding. Potential common shares consist of shares issuable upon the exercise of stock options
and warrants. Because the inclusion of potential common shares would be anti-dilutive for all
periods presented, diluted net loss per common share is the same as basic net loss per common
share.
The following table sets forth the potential common shares excluded from the calculation of
net loss per common share because their inclusion would be anti-dilutive:
September 30, | ||||||||
2009 | 2008 | |||||||
Options to purchase common stock |
3,324,660 | 2,033,793 | ||||||
Warrants to purchase common stock |
1,310,642 | 190,000 | ||||||
Total |
4,635,302 | 2,223,793 | ||||||
4. License Agreements
In September, 2009, the Company entered into a Patent and Technology Assignment Agreement with
Advirna, LLC (Advirna), a Colorado limited liability company co-founded by Anastasia Khvorova,
Chief Scientific Officer of RXi. Pursuant to the terms of the agreement, Advirna assigned to the
Company certain patent and technology rights related to chemically modified polynucleotides (the
Rights) and the Company granted to Advirna a fully paid-up license to the Rights in a specified
field.
Under the terms of the agreement, the Company will pay to Advirna an annual maintenance fee
beginning on January 1, 2011, certain payments upon the achievement of regulatory milestones and
royalty payments on the sales of certain products. The agreement will terminate upon the earlier of
(x) the expiration of the last to expire of the patent rights included in the agreement and (y) the
abandonment of the last to be abandoned of any patents included in the agreement, but either party
may terminate the agreement upon written notice of a material breach by the other party, subject to
certain cure provisions and restrictions. In addition, the Company may terminate the agreement upon
90 days prior written notice to Advirna and Advirna may terminate upon 90 days prior written
notice to the Company in the event the Company ceases to use reasonable efforts to research,
develop, license or otherwise commercialize the Rights. If the agreement expires in accordance with
its terms or is terminated by a party in the absence of a material breach or for cause in the event
that the Company fails to pay Advirna certain fees, the Company will assign the Rights back to
Advirna.
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As part of its business, the Company enters into significant licensing agreements. During the
second quarter of 2009, the Company terminated several license agreements previously disclosed in
the Companys Annual Report on Form 10-K for the year ended December 31, 2008 upon determining that
such licenses were no longer necessary for the conduct of its business.
These license agreements with third parties often require milestone and royalty payments based
on the progress of the asset through development stages. Milestone payments may be required, for
example, upon approval of the product for marketing by a regulatory agency. In certain agreements,
RXi is required to make royalty payments based upon a percentage of the sales. Because of the
contingent nature of these payments, they are not included in the table of contractual license
obligations shown below.
These arrangements may be material individually, and in the unlikely event that milestones for
multiple products covered by these arrangements were reached in the same period, the aggregate
charge to expense could be material to the results of operations. In addition, these arrangements
often give RXi the discretion to unilaterally terminate development of the product, which would
allow RXi to avoid making the contingent payments; however, RXi is unlikely to cease development if
the compound successfully achieves clinical testing objectives. The Companys contractual
obligations as they relate to these agreement that will require future cash payments relating to
minimum annual maintenance fees and milestone payments of September 30 are as follows (in
thousands):
Years Ending December 31, | ||||
2009 |
$ | 250 | ||
2010 |
2,068 | |||
2011 |
875 | |||
2012 |
930 | |||
2013 |
1,400 | |||
thereafter |
14,215 | |||
Total |
$ | 19,738 |
Of
the total amount due $1,000,000 can be paid in equity provided that the securities are
registered for sale at the time of such payment.
5. Fair Value Measurements
Effective January 1, 2008, the Company implemented FASB ASC Topic 820, Fair Value
Measurements and Disclosures (ASC 820) 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 as 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 cash equivalents as a Level 1 hierarchy. The valuation for Level 1
was determined based on a market approach using quoted prices in active markets for identical
assets. Valuations of these assets do not require a significant degree of judgment. The Company
categorized its warrants potentially settled in cash as a Level 2 hierarchy. The warrants are
measured at market value on a recurring basis and are being marked to market each quarter-end until
they are completely settled. The warrants are valued using the Black-Scholes method, using
assumptions consistent with our application of ASC 718. See footnote 6.
In accordance with the provisions of ASC 820 the Company has elected to defer implementation
of ASC 820, as it relates to its financial assets and liabilities that are recognized and disclosed
at fair value in the financial statements on a nonrecurring basis until January 1, 2010. The
Company is evaluating the impact, if any, this
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standard will have on its financial assets and liabilities. The adoption of ASC 820, as it relates
to the Companys financial assets and liabilities that are re-measured and reported at fair value
at least annually did not have an impact on the Companys financial results.
6. Equity
The Company filed a Registration Statement on Form S-3 (File No. 333-158968, the Registration
Statement) on May 4, 2009, which the SEC declared effective on May 22, 2009. Pursuant to the
Registration Statement, the Company may issue, in one or more offerings, shares of common stock,
preferred stock, warrants or debt securities at an aggregate offering price not to exceed
$30,000,000.
On March 17, 2009, the Company entered into a placement agency agreement, which was
subsequently amended on May 26, 2009 and July 22, 2009, with Rodman & Renshaw, LLC as the exclusive
placement agent, relating to a proposed offering by the Company of new securities to potential
investors. On July 30, 2009, the Company entered into definitive agreements for the sale and
issuance by the Company to certain investors of 2,385,715 units, with each unit consisting of (i)
one share of the Companys common stock, par value $0.0001 per share and (ii) a warrant to purchase
0.40 of a share of common stock, at a purchase price of $3.50 per unit (the Offering). The
Offering closed on August 4, 2009. The warrants will generally be exercisable for a period
beginning on February 3, 2010 and ending on August 3, 2014, and will carry a price per share equal
to $4.50, or 105% of the closing price of the common stock on July 30, 2009. The Company raised
gross proceeds of approximately $8,350,000 in the Offering and net cash proceeds, after deducting
the placement agents fees and other offering expenses payable by the Company, of approximately
$7.7 million. Total warrants issued in connection with the transaction were 954,285.
As part of the placement agency agreement, the Company issued a warrant to purchase 23,857
shares to the Rodman and Renshaw, LLC. The warrant has an exercise price of $4.38 per share. The
warrants are immediately vested and are exercisable until their expiration on August 3, 2014.
The Company follows the guidance of FASB ASC Topic 815-40, Derivatives and Hedging
Contracts in Entitys Own Stock (ASC 815-40), which establishes a framework for determining
whether certain freestanding and embedded instruments are indexed to a companys own stock for
purposes of evaluation of the accounting for such instruments under existing accounting literature.
Certain warrants issued in connection with the stock offering on August 3, 2009 were determined
not to be indexed to the Companys common stock as it is potentially settleable in cash. The fair
value of the warrants at the dates of issuance totaling $2,862,640 was recorded as a liability and
a cost of equity and was determined by the Black-Scholes option pricing model. Due to the fact
that we have limited trading history, our expected stock volatility assumption is based on a
combination of implied volatilities of similar entities whose share or option prices are publically
traded. The Company used a weighted average expected stock volatility
of 122.69%. The expected life
assumption is based on the contract term of five years. The dividend yield of zero is based on the
fact that we have no present intention to pay cash dividends. The
risk free rate of 1.72% used for
the warrant is equal to the zero coupon rate in effect at the time of the grant. The decrease in
the fair value of the warrants from the date of issuance to September 30, 2009 of $996,000 has been
included as an offset to general and administrative expenses in the accompanying condensed
statements of operations for the respective period. The fair value of the warrants at September
30, 2009 of $1,867,000 is included as a current liability in the accompanying balance sheet as of
that date and was determined by the Black-Scholes option pricing model. Due to the fact that we
have limited trading history, our expected stock volatility assumption is based on a combination of
implied volatilities of similar entities whose share or option prices are publically traded. The
Company used a weighted average expected stock volatility of 121.41%. The expected life assumption is
based on the contract term of five years. The dividend yield of zero is based on the fact that we
have no present intention to pay cash dividends. The risk free rate
of 2.31% used for the warrant is
equal to the zero coupon rate in effect at the end of the measurement
period.
7. Recent Accounting Pronouncements
In June 2009, the FASB issued Accounting Standard Update (ASU) No. 2009-01, Topic 105
Generally Accepted Accounting Principles, amendments based on Statement of Financial Accounting
Standards (SFAS) No. 168 The FASB Accounting Standards Codification and the Hierarchy of
Generally Accepted Accounting Principles. and establishes only two levels of U.S. GAAP,
authoritative and non-authoritative. The amendments established the FASB Accounting Standards
Codification (the Codification) as the source of authoritative accounting principles recognized
by the FASB to be applied by nongovernmental entities in the preparation of financial statements in
conformity with U.S. GAAP. Rules and interpretive releases of the SEC under authority of
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federal securities laws are also sources of authoritative U.S. GAAP for SEC registrants. On
the effective date of this statement, the Codification superseded all then-existing non-SEC
accounting and reporting standards. All other non-grandfathered non-SEC accounting literature not
included in the Codification has become non-authoritative. This statement is effective for
financial statements for interim or annual reporting periods ending after September 15, 2009. The
Company adopted this update during the three-month period ended September 30, 2009. As the
Codification was not intended to change or alter existing U.S. GAAP, the adoption of this update
did not have any impact on the Companys financial position, results of operations or cash flows.
In June 2009, the FASB issued SFAS No. 167, Amendments to FASB Interpretation No. 46(R) (has
not yet been updated via ASU). This statement amends the consolidation guidance applicable to
variable interest entities and is effective as of January 1, 2010. The Company is currently in the
process of evaluating the impact of this pronouncement.
In June 2009, the FASB issued SFAS No. 166, Accounting for Transfers of Financial Assets, an
amendment to SFAS No. 140 (has not yet been updated via ASU). This statement eliminates the
concept of a qualifying special-purpose entity, changes the requirements for derecognizing
financial assets, and requires additional disclosures in order to enhance information reported to
users of financial statements by providing greater transparency about transfers of financial
assets, including securitization transactions, and an entitys continuing involvement in and
exposure to the risks related to transferred financial assets. This statement is effective for
fiscal years beginning after November 15, 2009. The Company is currently in the process of
evaluating the impact of this pronouncement.
In May 2009, FASB ASC Topic 855, Subsequent Events (ASC 855) was issued. This statement
sets forth (i) the period after the balance sheet date during which management of a reporting
entity should evaluate events or transactions that may occur for potential recognition or
disclosure in the financial statements, (ii) the circumstances under which an entity should
recognize events or transactions occurring after the balance sheet date in its financial
statements, and (iii) the disclosures that an entity should make about events or transactions that
occurred after the balance sheet date. ASC 855 is effective for interim and annual periods ending
after June 15, 2009. The Company adopted ASC 855 in the quarter ending June 30, 2009. The
adoption of ASC 855 did not have any impact on the Companys financial position, results of
operations or cash flows. The Company evaluated all events or transactions that occurred after
September 30, 2009 through November 16, 2009, the date the Company issued these financial
statements. During this period the Company did not have any material recognizable subsequent
events other than what is disclosed in footnote 8.
In April 2009, the FASB issued the following: (i) FASB ASC Topic 820-10-65, Determining Fair
Value When the Volume and Level of Activity for the Asset or Liability have Significantly Decreased
and Identifying Transactions That Are Not Orderly (ASC 820-10-65), (ii) FASB ASC Topic
320-10-65, Recognition and Presentation of Other-Than-Temporary Impairment (ASC 320-10-65), and
(iii) FASB ASC Topic 825-10-65, Interim Disclosures about Fair Value of Financial Instruments
(ASC 825-10-65), which will be effective for interim and annual periods ending after June 15,
2009. ASC 820-10-65 provides guidance on how to determine the fair value of assets and liabilities
under ASC 820-10 in the current economic environment and reemphasizes that the objective of a fair
value measurement remains an exit price. If we were to conclude that there has been a significant
decrease in the volume and level of activity of the asset or liability in relation to normal market
activities, quoted market values may not be representative of fair value and we may conclude that a
change in valuation technique or the use of multiple valuation techniques may be appropriate. ASC
820-10-65 modify the requirements for recognizing other-than-temporarily impaired debt securities
and revise the existing impairment model for such securities, by modifying the current intent and
ability indicator in determining whether a debt security is other-than-temporarily impaired. ASC
825-10-65 enhance the disclosure of instruments under the scope of ASC 820 for both interim and
annual periods. The Company is currently evaluating these staff positions and the impact, if any,
that adoption will have on its financial position and results of operation.
Effective January 1, 2009, the Company adopted FASB ASC Topic 815-40-15, Derivatives and
Hedging Evaluating Whether an Instrument is Indexed to an Entitys Own Stock (ASC 815-40-15),
which addresses the accounting for certain instruments as derivatives. Under ASC 815-40-15
specific guidance is provided regarding requirements for an entity to consider embedded features as
indexed to the entitys own stock. See footnote 6 for the impact the adoption of ASC 815-40-15
hadon the Companys financial position, results of operations and cash flows.
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In June 2007, the Emerging Issues Task Force issued ASC Topic 730-20 Research and Development
Arrangements (ASC 730-20). ASC 730-20 addresses the diversity which exists with respect to the
accounting for the non-refundable portion of a payment made by a research and development entity
for future research and development activities. Under ASC 730-20, an entity would defer and
capitalize non-refundable advance payments made for research and development activities until the
related goods are delivered or the related services are performed. ASC 730-20 was effective for
fiscal years beginning after December 15, 2007 and interim periods within those years. The adoption
of ASC 730-20 did not have a material impact on the Companys financial statements.
8. Subsequent Events
On October 16, 2009, the Company granted 48,000 restricted stock units (RSUs) with a
contingent right to receive one share of Company common stock for each restricted stock unit to
certain directors. The RSUs will vest on January 2, 2010.
As part of a plan succession in leadership, Tod Woolf, Ph.D., resigned as President, Chief
Executive Officer and a member of the Board of Directors (the Board) of RXi Pharmaceuticals
Corporation, effective November 5, 2009. Dr. Woolfs decision to resign was not a result of any
disagreement with the Company or its management. As part of his severance agreement Dr. Woolf will
receive a lump sum payment of six months of salary in the amount of $187,500 and six months
accelerated vesting on all outstanding unvested options. Dr. Woolf will remain with the Company
as a member of its Scientific Advisory Board.
On
November 5, 2009, the Company's Board appointed Mr. Noah D. Beerman as
its President and Chief Executitve Officer. Under the terms of
Mr. Beermans employment agreement (the Agreement), the Company
appointed him to the Board on November 13, 2009. Mr.
Beerman is also entitled to a sign-on bonus of $25,000, options to purchase 350,000 shares of
common stock of the Company and an
annual base salary of $375,000. Mr. Beerman will be eligible to receive an annual performance bonus
of up to 50% of his salary based on the achievement of goals established by the Company and
determined by the Company to have been achieved. The Agreement expires on December 31, 2011, but
may be terminated under certain circumstance (as defined in the agreement). If the Company
terminates Mr. Beermans employment without cause (as defined in the Agreement), or if Mr. Beerman
terminates his employment for good reason (as defined in the Agreement), Mr. Beerman will be
entitled to (a) salary, option vesting and continued participation in the Company-sponsored group
benefit plan during the Severance Period (as defined in the Agreement) and (b) a bonus incentive
for targets achieved in full prior to the date of termination.
On
November 5, 2009, the Company granted Mr. Beerman options to
purchase 350,000 shares of common stock at an exercise
price of $2.19 per share, which represents the Companys closing stock price on that date. Each of
these options vest quarterly over a four year period and expire no later than 10 years from the
grant date.
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ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
In this document, we, our, ours and us refer to RXi Pharmaceuticals Corporation
This managements discussion and analysis of financial condition as of September 30, 2009 and
results of operations for the three and nine months ended September 30, 2009 and 2008 should be
read in conjunction with managements discussion and analysis of financial condition and results of
operations included in our Annual Report on Form 10-K for the year ended December 31, 2008.
The discussion and analysis below includes certain forward-looking statements related to
future operating losses and our potential for profitability, the sufficiency of our cash resources,
our ability to obtain additional equity or debt financing, possible partnering or other strategic
opportunities for the development of our products, as well as other statements related to the
progress and timing of product development, present or future licensing, collaborative or financing
arrangements or that otherwise relate to future periods, which are all forward-looking statements
as defined by the Private Securities Litigation Reform Act of 1995. These statements represent,
among other things, the expectations, beliefs, plans and objectives of management and/or
assumptions underlying or judgments concerning the future financial performance and other matters
discussed in this document. The words may, will, should, plan, believe, estimate,
intend, anticipate, project, and expect and similar expressions are intended to identify
forward-looking statements. All forward-looking statements involve certain risks, uncertainties and
other factors described elsewhere in our Annual Report on Form 10-K for the year ended December 31,
2008, that could cause our actual results of operations, performance, financial position and
business prospects and opportunities for this quarter and the periods that follow to differ
materially from those expressed in, or implied by, those forward-looking statements. We caution
investors not to place significant reliance on the forward-looking statements contained in this
report. These statements, like all statements in this report, speak only as of the date of this
report (unless another date is indicated) and we undertake no obligation to update or revise
forward-looking statements.
Overview
We are a discovery-stage biopharmaceutical company pursuing proprietary therapeutics based on
RNA interference, (RNAi), a naturally occurring cellular mechanism that has the potential to
effectively and selectively interfere with, or silence, expression of targeted disease-associated
genes. By utilizing our expertise in RNAi and the RNAi therapeutic platform that we have
established, we believe we will be able to discover and develop lead compounds and move them into
and through development for potential commercialization more efficiently than traditional drug
development approaches.
We were formed in 2006 by CytRx Corporation (CytRx) and four prominent RNAi researchers,
including Dr. Craig Mello, who was awarded the 2006 Nobel Prize in Medicine for his co-discovery of
RNAi. From 2003 through 2006, CytRx sponsored therapeutic RNAi research at the University of
Massachusetts Medical School (UMMS) and Massachusetts General Hospital. We commenced operations
in January 2007 after CytRx contributed to us its portfolio of RNAi therapeutic assets in exchange
for approximately 7.04 million shares of our common stock. These assets consisted primarily of
RNAi licenses and related intellectual property, and a nominal amount of equipment. The cost of the
licenses had previously been expensed by CytRx as in-process research and development and was
recorded in the predecessor financial statements at cost.
To date, RXis principal activities have consisted of conducting research and pre-clinical
development activities utilizing its RNAi therapeutic platform, acquiring key RNAi technologies and
patent rights through exclusive, co-exclusive and non-exclusive licenses, recruiting a RNAi-focused management
and scientific/clinical advisory team, capital raising activities and conducting business
development activities aimed at establishing development partnerships with pharmaceutical and
larger biotech companies.
We have not generated revenue to date and may not generate revenue in the foreseeable future,
if ever. We expect to incur significant operating losses as we advance our product candidates
through the drug development and regulatory process. In addition to increasing research and
development expenses, we expect general and administrative costs to increase as we add personnel.
We will need to generate significant revenues to achieve profitability and might never do so. In
the absence of product revenues, our potential sources of operational funding are expected to be
the proceeds from the sale of equity, funded research and development payments and payments under
partnership and collaborative agreements. We believe that our existing cash and potential proceeds
from the
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Standby
Equity Distribution Agreement (SEDA), we entered into on
January 30, 2008 with YA Global Master SPV Ltd. (YA Global), if any, should be sufficient to fund our
operations through the next 12 months. In the coming year, we will be dependent on obtaining
financing from third parties such as proceeds from the sale of equity, funded research and
development payments and payments under partnership and collaborative agreements, in order to
maintain our operations. We cannot assure that debt or additional equity or other funding will be
available to us on acceptable terms, or at all. If we fail to obtain additional funding when
needed, we would be forced to scale back or terminate our operations, or to seek to merge with or
to be acquired by another company.
As the Company has not generated any revenues since inception through September 30, 2009, we
are considered a development stage company for accounting purposes.
Results of Operations
For the Three Months ended September 30, 2009 and September 30, 2008
For the three months ended September 30, 2009, our net loss was approximately $2,987,000
compared with a net loss of $3,408,000 for the three months ended September 30, 2008. The loss
decreased by $421,000, or approximately 12%. Reasons for the variations in the losses between the
quarters are discussed below.
Research and Development Expense
Research and development expense consists primarily of compensation-related costs for our
employees dedicated to research and development activities and for our Scientific Advisory Board
(SAB) members as well as licensing fees, patent prosecution costs, and the cost of lab supplies
used in our research and development programs. We expect research and development expenses to
increase as we expand our discovery and development activities for RNAi therapeutics.
Total research and development expenses were approximately $2,091,000 for the three months
ended September 30, 2009, compared with $1,200,000 for the three months ended September 30, 2008.
The increase of $891,000 or 74% was primarily due to increases in costs associated with employee
compensation, due to an increase in headcount as well as an increase in patent costs related to
patent applications on internal discoveries.
General and Administrative Expense
General and administrative expenses include compensation-related costs for our employees
dedicated to general and administrative activities, legal fees, audit and tax fees, consultants and
professional services, and general corporate expenses.
General and administrative expenses were approximately $895,000 for the three months ended
September 30, 2009, compared with $2,264,000 for the three months ended September 30, 2008. The
decrease of $1,369,000, or 60% was primarily due to a $996,000 gain on the change in fair value of
warrants issued in conjunction with our registered direct offering, a $36,000 decrease in non-cash
share based compensation and a $598,000 decrease due to non-cash compensation expense related to a
warrant issued for business advisory services in the three months ended September 30, 2008. There
was no non-cash warrant compensation expense for the three months ended September 30, 2009.
Excluding these non-cash items general and administration expense were approximately $1,385,000 for
the three months ended September 30, 2009, compared with $1,124,000 for the three months ended
September 30, 2008, this increase was primarily due to an increase in headcount as well as an
increase in the use of investment advisory services.
Interest income
Interest income was negligible for the three months ended September 30, 2009, compared with
approximately $56,000 for the three months ended September 30, 2008. This decrease was primarily
due to the current interest rates available to us on our cash and cash equivalents during the three
months ended September 30, 2009. The key objectives of our investment policy are to preserve
principal and ensure sufficient liquidity, so our invested cash may not earn as high a level of
income as longer-term or higher risk securities, which generally have less liquidity
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and more volatility. The interest rates available on lower risk, shorter-term investments in
todays market are lower than rates available in the prior period.
Operating Results
We reported a loss from operations of $2,986,000 for the three months ended September 30,
2009, compared with a loss from operations of $3,464,000 in 2008. This decrease in loss of
$478,000, or 14% was due to increased operating expenses offset by a gain on the change in fair
value of warrants issued as noted above.
We reported a net loss of $2,987,000 for the three months ended September 30, 2009, compared
with a net loss of $3,408,000 in 2008. This decrease in net loss of $421,000 or 12%, equaled a
net loss per share of $0.19 and $0.25, respectively.
For the Nine Months ended September 30, 2009 and September 30, 2008
Research and Development Expense
Research and development expenses were $6,533,000 for the nine months ended September 30,
2009, compared with $5,054,000 for the nine months ended September 30, 2008. The increase of
$1,479,000 or 29% was due to higher staff and supplies costs, partially offset by combined employee
and non-employee stock based compensation of $1,577,000 in the nine months ended September 30,
2009, compared with $1,832,000 in the nine months ended September 30, 2008. Research and
development expense consists primarily of compensation-related costs for our employees dedicated to
research and development activities and for our SAB members, annual license maintenance fees, and
the cost of supplies and reagents used in our research and development programs. We expect research
and development expenses to increase as we expand our discovery and development activities for RNAi
therapeutics.
General and Administrative Expense
General and administrative expenses were $5,699,000 for the nine months ended September 30,
2009, compared with $5,477,000 for the nine months ended September 30, 2008. The increase of
$222,000, or 4%, was due to higher staff-related costs, including $1,475,000 in stock-based
compensation expense, and to $826,000 in warrant expense related to a warrant issued for business
advisory services and $281,000 in common stock issued under the SEDA offset by $996,000 in regards
to the change in fair value of common stock warrants issued with our registered direct offering.
General and administrative expenses include compensation-related costs for our employees dedicated
to general and administrative activities, legal fees, audit and tax fees, consultants and
professional services and general corporation expenses. Excluding these non-cash items general and
administration expense were approximately $4,113,000 for the nine months ended September 30, 2009,
compared with $3,488,000 for the nine months ended September 30, 2008, the increase of 625,000 was
primarily due to an increase in headcount as well as an increase in the use of investment advisory
services.
Interest income
Interest income was approximately $3,000 for the nine months ended September 30, 2009,
compared with approximately $159,000 for the nine months ended September 30, 2008. This decrease
was primarily due to larger average balances of our cash, cash equivalents or short-term
investments during the nine months ended September 30, 2008 as well as lower interest rates during
the nine months ended September 30, 2009.
Operating Results
We reported a loss from operations of $12,232,000 for the nine months ended September 30,
2009 compared with a loss from operations of $10,531,000 in 2008. The increase in loss of
$1,701,000, or 16%, was due primarily to increased expenses related to non-cash equity
compensation, as noted above.
We reported a net loss of $12,239,000 for the nine months ended September 30, 2009, compared
with a net loss of $10,372,000 in 2008. The increase in net loss of $1,859,000 or 18%, equaled a
net loss per share of $0.85 and $0.79, respectively.
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Liquidity and Capital Resources
In April 2007, we issued 3,273,292 shares of common stock (valued at approximately $5.00 per
share, based in part, upon the advice of the third-party valuation advisor and assuming the
issuance of 462,112 shares to UMMS pursuant to our license agreements with them) in exchange for
$15.0 million in cash from CytRx and the settlement of our inter-company account payable due to
CytRx of approximately $2.0 million. On June 24, 2008, we issued 1,073,299 shares of our common
stock to institutional investors at $8.12 per share resulting in aggregate gross proceeds of
approximately $8.7 million. On January 30, 2009, we entered into the SEDA with YA Global, pursuant
to which we may, at our option over a two-year period, periodically sell to YA Global shares of our
common stock, for a total purchase price of up to $25,000,000. On August 4, 2009, we closed the
Offering in which we sold 2,385,715 units at $3.50 per unit, each unit consisting of a share of our
common stock and a warrant to purchase .40 of a share of our common stock at an exercise price of
$4.50 per share resulting in aggregate gross proceeds of $8.4 million.
We have not had any revenue since inception nor are any revenues expected for the foreseeable
future. To maintain our business, it will be necessary for us to fund our operations, including
general and administrative expenses as well as expenditures for research and development. We
believe that our existing cash and proceeds from the SEDA, if any, should be sufficient to fund our
operations through the next 12 months. In the coming year, we will be dependent on obtaining
financing from third parties in order to maintain our operations. We cannot assure that debt or
additional equity or other funding such as proceeds from the sale of equity, funded research and
development payments and payments under partnership and collaborative agreements, will be available
to us on acceptable terms, or at all. If we fail to obtain additional funding when needed, we would
be forced to scale back or terminate our operations, or to seek to merge with or to be acquired by
another company.
Net Cash Flow from Operating Activities
Net cash used in operating activities was approximately $8,481,000 for the nine months ended
September 30, 2009, compared with $6,694,000 for the nine months ended September 30, 2008. The
increase of approximately $1,787,000 resulted primarily from a net loss of $12,239,000, less the
add back of non-cash items of $3,289,000, of which $3,052,000 related to stock-based compensation,
$826,000 related to stock warrant expense in exchange for services, $122,000 related to
depreciation and $469,000 related to changes in current assets and liabilities offset by $996,000
that reflects the fair value of warrants issued with the Offering.
Net Cash Flow from Investing Activities
Net cash used in investing activities was approximately $83,000 for the nine months ended
September 30, 2009, compared with net cash provided by investing activities of $694, 000 for the
nine months ended September 30, 2008. The decrease of approximately $777,000 in cash provided by
investing activities was primarily due to net redemption of short-term investments in 2008.
Net Cash Flow from Financing Activities
Net cash used in financing activities was $7,696,000 for the nine months ended September 30,
2009, compared with $7,901,000 for the nine months ended September 30, 2008. This decrease was
primarily due to net proceeds from the issuance of common stock in
the amount of $7,918,000 to institutional
investors in the second quarter of 2008 compared with net proceeds from the issuance of common stock in the amount of
$7,714,000 to institutional investors in the third quarter of 2009.
Off-Balance Sheet Arrangements
We have not entered into off-balance sheet financing, other than operating leases.
Critical Accounting Policies and Estimates
In our Annual Report on Form 10-K for the year ended December 31, 2008, we disclosed our
critical accounting policies and estimates upon which our financial statements are derived. There
have been no changes to these policies since December 31, 2008. Readers are encouraged to review
these disclosures in conjunction with the review of this quarterly report on Form 10-Q.
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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, our Chief Executive
Officer and Principal Accounting Officer (the Certifying Officers), 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 Officers,
as appropriate to allow timely decisions regarding required disclosure. Based on these evaluations,
the Certifying Officers have 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 Officers, 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 September 30, 2009 that has materially affected, or is reasonably
likely to materially affect, our internal control over financial reporting.
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RXi PHARMACEUTICALS CORPORATION
PART II OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
None
ITEM 1.A RISK FACTORS
You should consider the Risk Factors included under Item 1A. of our quarterly report on Form 10-Q
for the six months ended June 30, 2009, filed on August 14, 2009 with the SEC in addition to our
annual report on Form 10-K for the year ended December 31, 2008, filed on March 18, 2009 with the
SEC.
The FDA approval process may be delayed for any drugs we develop that require the use of
specialized drug delivery devices or vehicles.
Some drug candidates that we develop may need to be administered using specialized
vehicles that deliver RNAi therapeutics directly to diseased parts of the body. For example, we
anticipate using an implantable pump to deliver drug candidates to
the nervous system. The drug delivery vehicles that we expect to
deliver our drug candidates have not been approved by the FDA or other regulatory
agencies. In addition, the FDA may regulate the
product as a combination product of a drug and a device or require additional approvals or
clearances for the modified delivery.
Further, to the extent the specialized delivery vehicle is owned by another company, we
would need that companys cooperation to implement the necessary changes to the vehicle, or its
labeling, and to obtain any additional approvals or clearances. Any delays in finding suitable drug
delivery vehicles to administer RNAi therapeutics directly to diseased parts of the body could
negatively affect our ability to successfully develop our RNAi therapeutics.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
None
ITEM 5. OTHER INFORMATION
None
ITEM 6. EXHIBITS
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EXHIBIT INDEX
Exhibit | ||||
Number | Description | |||
3.1 | Form of Amended and Restated Certificate of Incorporation of RXi
Pharmaceuticals Corporation(1) |
|||
3.2 | Form of Amended and Restated By-laws of RXi Pharmaceuticals Corporation(1) |
|||
10.1 | Form of Securities Purchase Agreement(2) |
|||
10.2 | Patent and Technology Assignment Agreement between RXi Pharmaceuticals
Corporation and Advirna, LLC, dated September 21, 2009 + |
|||
31.1 | Sarbanes-Oxley Act Section 302 Certification of Noah D. Beerman |
|||
31.2 | Sarbanes-Oxley Act Section 302 Certification of Amy B. Tata |
|||
32.1 | Sarbanes-Oxley Act Section 906 Certification of Noah D. Beerman and Amy B. Tata |
(1) | Previously filed as an Exhibit to the Companys Registration Statement on Form S-1 filed on October 30, 2007 (File No. 333-147009) and incorporated by reference herein | |
(2) | Previously filed as an Exhibit to the Companys Current Report on Form 8-K filed on July 31, 2009. | |
+ | Confidential treatment has been requested for certain portions which have been blanked out in the copy filed with the Securities and Exchange Commission. The omitted information has been filed separately with the Securities and Exchange Commission. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly
caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
RXi PHARMACEUTICALS CORPORATION (Registrant) |
||||
By: | /s/Noah D. Beerman | |||
Noah D. Beerman | ||||
President and Chief Executive Officer (Principal Executive Officer) |
||||
By: | /s/ Amy B. Tata | |||
Amy B. Tata | ||||
Principal Accounting Officer and Controller (Principal Accounting Officer) Date: November 16, 2009 |
||||
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