SELLAS Life Sciences Group, Inc. - Quarter Report: 2010 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, 2010
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 8, 2010, RXi Pharmaceuticals Corporation had 18,372,759 shares of common stock,
$0.0001 par value, outstanding.
RXi PHARMACEUTICALS CORPORATION
FORM 10-Q QUARTER ENDED SEPTEMBER 30, 2010
`
FORM 10-Q QUARTER ENDED SEPTEMBER 30, 2010
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 data)
(Unaudited)
(Amounts in thousands, except share data)
(Unaudited)
September 30, | December 31, | |||||||
2010 | 2009 | |||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 2,836 | $ | 5,684 | ||||
Short-term investments |
5,996 | | ||||||
Prepaid expenses and other current assets |
334 | 120 | ||||||
Total current assets |
9,166 | 5,804 | ||||||
Equipment and furnishings, net |
423 | 432 | ||||||
Deposits |
16 | 16 | ||||||
Total assets |
$ | 9,605 | $ | 6,252 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 836 | $ | 625 | ||||
Accrued expenses and other current liabilities |
1,176 | 1,077 | ||||||
Current maturities of capital lease obligations |
52 | 52 | ||||||
Fair value of common stock mandatorily redeemable for cash upon
the exercise of warrants |
785 | | ||||||
Fair value of common stock warrants potentially settleable in cash |
3,425 | 3,721 | ||||||
Total current liabilities |
6,274 | 5,475 | ||||||
Capital lease obligations, net of current maturities |
43 | 36 | ||||||
Total liabilities |
6,317 | 5,511 | ||||||
Commitments and contingencies (Note 6) |
||||||||
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;
19,047,759 shares issued and 18,372,759 shares outstanding and
16,207,625 shares issued and outstanding at September 30, 2010
and December 31, 2009, respectively |
3 | 2 | ||||||
Additional paid-in capital |
61,046 | 44,489 | ||||||
Deficit accumulated during the development stage |
(53,912 | ) | (43,750 | ) | ||||
Less treasury shares at cost, 675,000 and 0 shares at September
30, 2010 and December 31, 2009, respectively |
(3,849 | ) | | |||||
Total stockholders equity |
3,288 | 741 | ||||||
Total liabilities and stockholders equity |
$ | 9,605 | $ | 6,252 | ||||
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 per share data)
(Unaudited)
(Amounts in thousands, except 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, | ||||||||||||||||
2010 | 2009 | 2010 | 2009 | 2010 | ||||||||||||||||
Expenses: |
||||||||||||||||||||
Research and development expense |
$ | 1,606 | $ | 1,945 | $ | 4,589 | $ | 4,956 | $ | 25,226 | ||||||||||
Research and development
employee stock based
compensation expense |
274 | 219 | 814 | 631 | 2,137 | |||||||||||||||
Research and development
non-employee stock based
compensation expense |
56 | (73 | ) | 723 | 946 | 6,043 | ||||||||||||||
Fair value of common stock in
exchange for licensing rights |
| | | | 3,954 | |||||||||||||||
Total research and development
expenses |
1,936 | 2,091 | 6,126 | 6,533 | 37,360 | |||||||||||||||
General and administrative |
1,126 | 1,385 | 4,228 | 4,113 | 19,845 | |||||||||||||||
General and administrative
employee stock based
compensation |
503 | 506 | 1,921 | 1,475 | 6,765 | |||||||||||||||
Common stock warrants issued
for general and administrative
expenses |
154 | | 654 | 826 | 2,230 | |||||||||||||||
Fair value of common stock
issued in exchange for general
and administrative expenses |
| | | 281 | 281 | |||||||||||||||
Total general and
administrative expenses |
1,783 | 1,891 | 6,803 | 6,695 | 29,121 | |||||||||||||||
Operating loss |
(3,719 | ) | (3,982 | ) | (12,929 | ) | (13,228 | ) | (66,481 | ) | ||||||||||
Interest income (expense) |
3 | (1 | ) | 5 | (3 | ) | 628 | |||||||||||||
Other income (expense) |
(419 | ) | 996 | 2,762 | 992 | 1,900 | ||||||||||||||
Net loss |
$ | (4,135 | ) | $ | (2,987 | ) | $ | (10,162 | ) | $ | (12,239 | ) | $ | (63,953 | ) | |||||
Net loss per common share: |
||||||||||||||||||||
Basic and diluted loss per share |
$ | (0.23 | ) | $ | (0.19 | ) | $ | (0.57 | ) | $ | (0.85 | ) | N/A | |||||||
Weighted average common shares
outstanding: |
||||||||||||||||||||
Basic and diluted |
18,372,759 | 15,327,482 | 17,717,610 | 14,319,262 | 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, | ||||||||||
2010 | 2009 | 2010 | ||||||||||
Cash flows from operating activities: |
||||||||||||
Net loss |
$ | (10,162 | ) | $ | (12,239 | ) | $ | (63,953 | ) | |||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||||||
Depreciation and amortization expense |
127 | 122 | 456 | |||||||||
Loss on disposal of equipment |
| 4 | 12 | |||||||||
Non-cash rent expense |
| | 29 | |||||||||
Accretion and receipt of discount on short-term investments |
(6 | ) | | 29 | ||||||||
Non-cash stock based compensation |
3,458 | 3,052 | 14,947 | |||||||||
Fair value of common stock warrants issued in exchange for services |
654 | 826 | 2,230 | |||||||||
Fair value of common stock issued as a commitment fee in connection
with the SEDA |
| 281 | 281 | |||||||||
Change in fair value of common stock warrants issued in connection with
various equity financings potentially settleable in cash |
(2,762 | ) | (996 | ) | (1,904 | ) | ||||||
Fair value of common stock issued in exchange for licensing rights |
| | 3,954 | |||||||||
Changes in assets and liabilities: |
||||||||||||
Prepaid expenses |
(214 | ) | (172 | ) | (334 | ) | ||||||
Accounts payable |
211 | 140 | 836 | |||||||||
Due to former parent |
| | (207 | ) | ||||||||
Accrued expenses and other current liabilities |
306 | 501 | 1,383 | |||||||||
Net cash used in operating activities |
(8,388 | ) | (8,481 | ) | (42,241 | ) | ||||||
Cash flows from investing activities: |
||||||||||||
Purchase of short-term investments |
(5,990 | ) | | (37,532 | ) | |||||||
Maturities of short-term investments |
| | 31,507 | |||||||||
Cash paid for purchase of equipment and furnishings |
(65 | ) | (82 | ) | (646 | ) | ||||||
Disposal of equipment and furnishings |
| (1 | ) | | ||||||||
Cash paid for lease deposit |
| | (45 | ) | ||||||||
Net cash used in investing activities |
(6,055 | ) | (83 | ) | (6,716 | ) | ||||||
Cash flows from financing activities: |
||||||||||||
Net proceeds from issuance of common stock |
15,235 | 7,714 | 46,637 | |||||||||
Cash paid for repurchase of common stock |
(3,849 | ) | | (3,849 | ) | |||||||
Net proceeds from exercise of common stock options |
255 | | 611 | |||||||||
Repayments of capital lease obligations |
(46 | ) | (18 | ) | (102 | ) | ||||||
Cash advances from former parent company, net |
| | 8,766 | |||||||||
Net cash provided by financing activities |
11,595 | 7,696 | 51,793 | |||||||||
Net increase (decrease) in cash and cash equivalents |
(2,848 | ) | (868 | ) | 2,836 | |||||||
Cash and cash equivalents at the beginning of period |
5,684 | 9,856 | | |||||||||
Cash and cash equivalents at end of period |
$ | 2,836 | $ | 8,988 | $ | 2,836 | ||||||
Supplemental disclosure of cash flow information: |
||||||||||||
Cash received during the period for interest |
$ | 1 | $ | 1 | $ | 725 | ||||||
Cash paid during the period for interest |
$ | | $ | | $ | 7 | ||||||
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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, | ||||||||||
2010 | 2009 | 2010 | ||||||||||
Supplemental disclosure of non-cash investing and financing
activities: |
||||||||||||
Settlement of corporate formation expenses in exchange for
common stock |
$ | | $ | | $ | 978 | ||||||
Fair value of warrants issued in connection with common stock
recorded as a cost of equity |
$ | 2,466 | $ | 2,863 | $ | 5,329 | ||||||
Fair value of shares mandatorily redeemable for cash upon the
exercise of warrants |
$ | 785 | $ | | $ | 785 | ||||||
Allocation of management expenses |
$ | | $ | | $ | 551 | ||||||
Equipment and furnishings exchanged for common stock |
$ | | $ | | $ | 48 | ||||||
Equipment and furnishings acquired through capital lease |
$ | 53 | $ | 101 | $ | 197 | ||||||
Value of restricted stock units issued in lieu of cash bonuses |
$ | 207 | $ | | $ | 207 | ||||||
Value of restricted stock units issued in lieu of bonuses
included in accrued expenses |
$ | 47 | $ | | $ | 47 | ||||||
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 RNA
Interference (RNAi) for the treatment of human diseases. By utilizing the Companys expertise in
RNAi and the RNAi therapeutic platform the Company has established, the Company believes it will be
able to develop a pipeline of therapeutics for the treatment of a number of diseases. The Company
is currently focusing its internal therapeutic development efforts in two main core areas, dermal
anti-scarring and retinal disorders, and plans to advance product candidates within these core
areas into early development and through clinical proof-of-concept. RXi may also pursue the
development of product candidates and explore additional indications and proceed through
preclinical development, itself and with potential partners, in areas that are of strategic
interest to the Company.
To date, RXis principal activities have consisted of conducting research and pre-clinical
development activities, acquiring key RNAi technologies and patent rights through exclusive,
co-exclusive and non-exclusive licenses, recruiting an RNAi-focused management team and scientific
advisory board, capital raising activities and conducting business development activities aimed at
establishing development partnerships with pharmaceutical and larger biotechnology companies. As
the Company has not generated any revenues from inception through September 30, 2010, the Company
is considered a development stage company for financial reporting 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 biotechnology 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, both government and
private grants 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, 2009 included in the Companys Annual Report on Form 10-K filed with the SEC on March
31, 2010. 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, 2010 and 2009, as well as the
cumulative financial information for the period from January 1, 2003 (date of inception) through
September 30, 2010, 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, 2009. The
Companys operating results will fluctuate for the foreseeable future. Therefore, period-to-period
comparisons should not be relied upon as predictive of the results in future periods.
Uses
of Estimates in Preparation of Financial Statements
The preparation of financial statements in accordance with U.S. GAAP requires management to
make estimates and assumptions that affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the date of the financial statements and the
reported amounts of revenues and expenses during the reporting period. Actual results could differ
from these estimates.
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Reclassifications
Certain prior year amounts have been reclassified to conform with the current years
presentation.
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. In accordance with
Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) Topic
815-40, Derivatives and Hedging Contracts in Entitys Own Stock, 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 upon the occurrence of certain events set forth in the warrant agreement.
Obligations to Repurchase Shares of the Companys Equity Securities
In accordance with FASB ASC Topic 480-10, Distinguishing Liabilities from Equity, the
Company recognizes all obligations to repurchase shares of its equity securities that require or
may require the Company to settle the obligation by transferring assets, as liabilities or assets
in some circumstances measured at fair value with changes in fair value reflected as current period
income or loss and are accounted for as such.
2. Fair Value Measurements
In January 2010, the FASB issued Accounting Standards Update (ASU) 2010-06, Improving
Disclosures about Fair Value Measurements, (ASU 2010-06). The standard amends FASB ASC Topic
820, Fair Value Measurements and Disclosures, (ASC 820) to require additional disclosures
related to transfers in and out of Levels 1 and 2 and for activity in Level 3 and clarifies other
existing disclosure requirements. The Company adopted ASU 2010-06 beginning January 1, 2010. This
update had no impact on the Companys financial statements.
Effective January 1, 2008, the Company implemented 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 and short-term investments as 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 settleable in cash and its common stock
mandatorily redeemable for cash upon the exercise of warrants as a Level 2 hierarchy. The warrants
are measured at market value on a recurring basis using the fixed monetary amount of each warrant that would be received by the Company under the conditions specified in
the stock redemption agreement 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. The common stock is measured at fair value based on
the repurchase price. See footnote 7.
In accordance with the provisions of ASC 820, the Company elected to defer implementation of
ASC 820, as it relates to its non-financial assets and liabilities that are recognized and
disclosed at fair value in the financial statements on a nonrecurring basis until the first quarter
of 2010. 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.
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3. Short-term Investments
The Company purchased zero coupon U.S. Treasury Bills at a discount during the second quarter
of 2010. The securities mature in November 2010. The investments were classified as
held-to-maturity and are valued at amortized cost, which approximates fair value. The Company did
not have any short-term investments as of December 31, 2009.
4. Stock Based Compensation
The Company follows the provisions of the FASB ASC Topic 718, Compensation Stock
Compensation (ASC 718), which requires the measurement and recognition of compensation expense
for all stock based payment awards made to employees, 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 three and nine month period ended
September 30, 2010 and 2009, the following assumptions were used:
For the Three Months Ended | For the Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2010 | 2009 | 2010 | 2009 | |||||||||||||
Weighted average risk-free interest rate |
N/A | 3.10 | % | 3.02 | % | 2.32 | % | |||||||||
Weighted average expected volatility |
N/A | 121.74 | % | 121.19 | % | 120.46 | % | |||||||||
Weighted average expected lives (years)` |
N/A | 7.00 | 7.37 | 7.40 | ||||||||||||
Weighted average expected dividend yield |
N/A | 0.00 | % | 0.00 | % | 0.00 | % |
The weighted average fair value of options granted during the nine month period ended
September 30, 2010 and 2009 was $4.34 and $3.71 per share, respectively.
The weighted average fair value of options granted during the three month period ended
September 30, 2009 was $2.57 per share. There were no options granted during the three month
period ended September 30, 2010.
RXis expected common stock price volatility assumption is based upon the volatility of a
combination of similar entities whose share or option prices are publically trade. 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, 2010 through September
30, 2010:
Total Number | Weighted Average | Aggregate | ||||||||||
of Shares | Exercise Price | Intrinsic Value | ||||||||||
Outstanding at January 1, 2010 |
3,582,339 | $ | 5.16 | $ | 231,000 | |||||||
Granted |
898,768 | 4.87 | 10,816 | |||||||||
Exercised |
53,500 | 4.75 | 163,890 | |||||||||
Cancelled |
108,295 | 4.72 | | |||||||||
Outstanding at September 30, 2010 |
4,319,312 | $ | 5.12 | $ | 241,816 | |||||||
Options exercisable at September 30, 2010 |
2,956,377 | $ | 5.21 | $ | 53,895 | |||||||
The weighted average remaining contractual life of options outstanding and exercisable at
September 30, 2010 was 7.59 years and 7.27 years, respectively.
The aggregate intrinsic values of outstanding and exercisable options at September 30, 2010
were calculated based on the closing price of the Companys common stock on September 30, 2010 of
$2.85 per share less the exercise price of those shares. The aggregate intrinsic values of options
exercised was calculated based on the difference between the exercise price of the underlying
awards and the quoted price of the Companys common stock on the date of exercise.
5. 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, | ||||||||
2010 | 2009 | |||||||
Options to purchase common stock |
4,319,312 | 3,324,600 | ||||||
Warrants to purchase common stock |
2,100,642 | 1,310,642 | ||||||
Total |
6,419,954 | 4,635,302 | ||||||
6. License Agreements
As part of its business, the Company enters into numerous licensing agreements. 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 net sales.
The expenditures required under these arrangements may be material individually in the event
that the Company develops product candidates covered by the intellectual property licensed under
any such arrangement, and in the unlikely event that milestones for multiple products covered by
these arrangements were reached in the same period,
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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 agreements that will require future cash payments relating to minimum annual
maintenance fees and milestone payments have not changed significantly from December 31, 2009.
7. Equity
On March 22, 2010, the Company entered into a placement agency agreement relating to a
proposed offering by the Company of new securities to potential investors. On March 23, 2010, the
Company entered into definitive agreements for the sale and issuance by the Company to certain
investors of 2,700,000 units, with each unit consisting of one share of the Companys common stock
and a warrant to purchase 0.20 of a share of the Companys common stock, at a purchase price of
$6.00 per unit (the 2010 Offering). The 2010 Offering closed on March 26, 2010. The Company
issued 540,000 warrants with an exercise price of $6.00 per share that are exercisable beginning on
September 26, 2010 until their expiration on March 26, 2016. The Company raised gross proceeds of
approximately $16.2 million in the 2010 Offering and net cash proceeds, after deducting the
placement agent fees and other offering expenses payable by the Company, of approximately $15.2
million.
As part of the 2010 Offering, RXi entered in a stock redemption agreement whereby the
Company was required to use 25% of the net proceeds from the 2010 Offering to repurchase from CytRx
Corporation (CytRx) 675,000 shares of the Companys common stock held by CytRx (CytRx shares).
The Company repurchased such shares on March 29, 2010. The values of the shares at the date of
repurchase totaling $3,849,000 were recorded at cost and have been included in treasury stock in
the accompanying balance sheet at September 30, 2010. The Company is also required to use 25% of
the proceeds from the exercise of warrants issued in the 2010 Offering to repurchase from CytRx a
number of CytRx Shares equal to 25% of shares issued upon the exercise of such warrants. To date,
no such warrants have been exercised.
Shares of common stock that are mandatorily redeemable under the stock redemption agreement
upon the exercise of warrants issued in the 2010 Offering were determined to embody an obligation
that may require the Company to settle the obligation by transferring assets, and as such, have
been classified as a liability. The fair value of the common stock potentially redeemable under
the stock redemption agreement totaling $785,000 was recorded as a liability and a cost of equity
and was determined using the fixed monetary amount of each warrant multiplied by assumptions
regarding the number and timing of warrants to be exercised. The Company believes that, assuming
its stock price increases above the $6.00 exercise price of the warrants issued in the 2010
Offering, the warrants will be exercised within the twelve months after they became exercisable in
September 2010. Consequently the fair value of the obligation is $810,000 which is the maximum
amount of cash that would be paid by the Company under the conditions specified in the stock
redemption agreement, if all of the shares required to be redeemed were repurchased discounted over
one year at a rate of 3.18%.
Certain warrants issued in connection with the 2010 Offering were determined not to be indexed
to the Companys common stock as they are potentially settleable in cash. The fair value of the
warrants at the dates of issuance totaling $2,466,000 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 119.49%. The expected life assumption
is based on the contract term of 6.5 years. The dividend yield of zero is based on the fact that
the Company has no present intention to pay cash dividends. The risk free rate of 3.22% 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, 2010 is $1,164,000 and has been included in
other income and expense in the accompanying condensed statements of expenses for the nine months
ended September 30, 2010. The fair value of the warrants at September 30, 2010 of $1,303,000 is
included as a current liability in the accompanying balance sheets and was determined by the
Black-Scholes option pricing model. In the model, the Company used a weighted average expected
stock volatility of 129.55%. The expected life assumption is based on the contract term of 6.0
years. The dividend yield of zero is based on the fact that the Company has no present intention
to pay cash dividends. The risk free rate of 1.58% used for the warrant is equal to the zero
coupon rate in effect on the date of the re-measurement.
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Certain warrants issued in connection with a registered direct stock offering on August 3,
2009 (the 2009 Offering) were determined not to be indexed to the Companys common stock as they
are potentially settleable in cash. The fair value of the warrants at the dates of issuance
totaling $2,863,000 was recorded as a liability and a cost of equity and was determined by the
Black-Scholes option pricing model. In the model, 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 the Company has 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, 2010 is $740,000 of which $1,599,000 has been included in
other income and expense in the accompanying condensed statements of expenses for the nine months
ended September 30, 2010. The fair value of the warrants at September 30, 2010 of $2,122,000 is
included as a current liability in the accompanying balance sheets and was determined by the
Black-Scholes option pricing model. RXis 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 129.55%. The expected
life assumption is based on the contract term of 4 years. The dividend yield of zero is based on
the fact that the Company has no present intention to pay cash dividends. The risk free rate of
0.93% used for the warrant is equal to the zero coupon rate in effect on the date of the
re-measurement. The most significant factor causing the decline in fair value is the decline in
the Companys stock price.
8. Recent Accounting Pronouncements
In April 2010, the FASB issued ASU 2010-17 which provides guidance in applying the milestone
method of revenue recognition to research or development arrangements. Under this guidance,
management may recognize revenue contingent upon the achievement of a milestone in the period in
which the milestone is achieved only if the milestone meets all the criteria within the guidance to
be considered substantive. This standard is effective on a prospective basis for research and
development milestones achieved in fiscal years beginning on or after June 15, 2010. The Company
does not expect the adoption of ASU 2010-17 to have a material impact on the Companys financial
statements.
In June 2009, the FASB issued FASB ASC Topic 810-10, Consolidations, (ASC 810-10), which
amends the consolidation guidance applicable to variable interest entities and was effective as of
January 1, 2010. The adoption of ASC Topic 810-10 did not have a material impact on the Companys
financial statements.
In June 2009, the FASB issued FASB ASC Topic 860-10, Transfers and Servicing of Financial
Assets, (ASC 860-10), which 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
adoption of ASC Topic 860-10 did not have a material impact on the Companys financial statements.
9. Subsequent Events
The Company evaluated all events or transactions that occurred after September 30, 2010 up
through the date these condensed financial statements were issued. Other than what is disclosed
below, during this period, the Company did not have any material recognizable or unrecognizable subsequent events.
On October 15, 2010, the Company granted options to purchase 28,000 shares of common stock to
employees. These options had an exercise price of $3.13 per share, which represented the Companys
closing stock price on that date. These options vest quarterly over a four year period and expire
no later than 10 years from the grant date.
In November 2010, the United States Internal Revenue Service (IRS) awarded four Therapeutic
Discovery Project (TDP) grants to the Company as part of the Patient Protection and Affordable Care
Act of 2010. The grants will help fund the pre-clinical development of RNAi therapeutics using the
Companys novel, proprietary therapeutic platform, which includes both novel RNAi compounds and
advanced delivery technologies. The allocation of the TDP grants took into consideration which
projects show the greatest potential to create and sustain
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high-quality, high-paying U.S. jobs and to advance U.S. competitiveness in life, biological, and medical sciences. RXis TDPs will focus on the following areas:
1. Development of self-delivering RNA Interference (RNAi) therapeutic for fibrotic disease;
2. Self-Delivering RNA Interference Therapeutic for Age-Related Macular Degeneration (AMD);
3. Self-Delivering RNA Interference Therapeutic for ALS (Lou Gehrigs Disease); and
4. Oral Delivery of Glucose Encapsulated siRNAs for Rheumatoid Arthritis (RA).
Each of the four TDP grants were approved for $244,000, for a total of $978,000. Of this
amount, approximately $792,000 of the tax free grant is expected to be received by the end of
fiscal year 2010. The remaining grant of approximately $186,000 is expected to be received in
January 2011.
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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, 2010 and
results of operations for three and nine months ended September 30, 2010 and 2009 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, 2009 which
was filed with the SEC on March 31, 2010.
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,
2009, 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 comprehensive RNAi therapeutic platform that we
have established, we believe we will be able to discover and develop lead compounds and progress
them into and through clinical development for potential commercialization.
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.
Our proprietary therapeutic platform is comprised of two main components:
| Novel RNAi Compounds, referred to as rxRNA compounds, that are distinct from, and we believe convey significant advantages over, classic siRNA (conventionally-designed small interfering RNA compounds), and offer many of the properties that we believe are important to the clinical development of RNAi-based drugs. We have developed a number of unique forms of rxRNA compounds, all of which have been shown to be highly potent both in vitro and in vivo. These RNAi compounds include rxRNAoriTM, rxRNAsoloTM and sd-rxRNATM, or self delivering RNA. Based on our research we believe that these different, novel siRNA configurations have various advantages for therapeutic use. These advantages include high potency, increased resistance to nucleases and off-target effects, and, in the case of the sd-rxRNA compounds, access to cells and tissues with no additional formulation required. | ||
| Advanced Delivery Technologies, may enable the delivery of our rxRNA compounds to treat a variety of acute and chronic diseases using both local and systemic approaches, potentially providing a competitive |
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advantage in the development of many RNAi therapeutic compounds. Our suite of delivery technologies is comprised of delivery vehicles, which can be combined with various rxRNA compounds, as well as sd-rxRNA compounds, which are chemically modified and have the unique property of entering cells and tissues to effect silencing without the need for any additional delivery vehicle. This suite of delivery technologies has broad potential applications for multiple therapeutic areas targeting both local and systemic applications. |
Therapeutic Programs
Our therapeutic platform has the potential to be broadly applicable to multiple therapeutic
areas. We intend to focus our internal therapeutic development efforts in two main core areas,
dermal anti-scarring and retinal disorders. By utilizing our expertise in RNAi and the RNAi
technology platform we have built, we believe we will be able to discover and develop lead
compounds and progress them into clinical development more efficiently than traditional drug
discovery approaches. We are planning to advance product candidates from these core areas into
early development and through clinical proof-of-concept. We will also explore additional
indications and proceed through preclinical development, ourselves and with potential partners, in
areas that are of strategic interest to us.
Core Areas
The Company is currently focusing its internal therapeutic development efforts in the
following two core areas:
Fibrosis Dermal Anti-Scarring
Data with our sd-rxRNA compounds in preliminary pre-clinical models using local administration
to the skin have shown robust delivery and effective target gene silencing. We intend to select an
anti-scarring development candidate in 2010 and have targeted filing an IND for the product
candidate in 2011. Our success with RNAi therapeutics in anti-scarring may provide additional
opportunities in other dermatology applications as well as in anti-fibrotic indications including
pulmonary fibrosis, liver fibrosis, acute spinal cord injury, ocular scarring and restenosis.
Ophthalmology Retinal Disorders
We have shown data demonstrating unprecedented delivery and effective target gene silencing in
animal models in the retina with sd-rxRNA compounds. By applying our unique technology with
existing and novel targets, and potentially multiple targets, we believe we have the potential to
develop next generation treatments for retinal disorders. Further, we believe that there is
opportunity to potentially improve on existing therapies, extend the time required between doses
and utilize new modes of administration for delivery to the eye. We intend to select a retinal
disorder development candidate in 2011.
Strategic Areas
Our team has experience targeting genes in virtually every major therapeutic area, and we
believe we will discover many more drug candidates than we can develop with our own resources. We
will explore additional indications and proceed through preclinical development ourselves and with
potential partners, in areas that are of strategic interest to us, including the areas of
neurological disorders and oncology as discussed below.
Neurology Spinal Cord
We are exploring indications accessible by spinal cord delivery of sd-rxRNA. Direct dosing to
the spinal cord could be used for severe central nervous system or spinal cord diseases in both
orphan and non-orphan indications. We may also be able to leverage early proof-of-concept studies
and collaborations to advance programs in this area. We intend to advance potential candidates
through preclinical studies and seek potential partners to help support further development.
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Oncology Liver Metastases and Hepatocellular Carcinoma
In the area of oncology, we will be concentrating initially on liver metastases and
hepatocellular carcinoma using systemic delivery of sd-rxRNA or other rxRNA compounds in
combination with delivery vehicles. Given the emerging emphasis on multi-targeted therapies for
cancer, we believe we have the ability to develop RNAi compounds against multiple gene targets to
generate effective combination treatments. The unique features of sd-rxRNA may offer a new
alternative to treating cancers and could lead to attractive product candidates to further advance
in conjunction with partners.
Financial Overview
To date, our principal activities have consisted of conducting discovery research and
pre-clinical development activities utilizing our RNAi therapeutic platform, acquiring RNAi
technologies and patent rights through exclusive, co-exclusive and non-exclusive licenses,
recruiting an RNAi-focused management team and scientific advisory board, capital raising
activities and conducting business development activities aimed at establishing research and
development partnerships with pharmaceutical and larger biotechnology 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, both government and
private grants and payments under partnership and collaborative agreements. As we have not
generated any revenues since inception through September 30, 2010, we are considered a development
stage company for financial reporting purposes.
We believe that our existing cash and short-term investments should be sufficient to fund our
operations through at least the first half of fiscal 2011. In addition, we also have funds
available to us upon the issuance of shares of our common stock under the Standby Equity
Distribution Agreement (the SEDA) that we entered into on January 30, 2009 with YA Global Master
SPV Ltd. (YA Global) which expires on January 30, 2011. In the future, we will be dependent on
obtaining funding from third parties such as proceeds from the sale of equity, funded research and
development payments, both government and private grants and payments under partnership and
collaborative agreements, in order to maintain our operations and meet our obligations to
licensors. There is no guarantee that debt, additional equity or other funding will be available to
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.
Results of Operations
For the Three and Nine Months Ended September 30, 2010, and September 30, 2009
Operating Results
We reported a loss from operations of $3,719,000, which includes $987,000 of non-cash stock
based compensation, for the three months ended September 30, 2010 compared with a loss from
operations of $3,982,000, which includes $652,000 of non-cash stock based compensation, in the same
period of 2009. The decrease in loss of $263,000, or 7%, was due primarily to a $259,000 decrease
in general and administrative expenses and a $339,000 decrease in research and development expenses offset by a $335,000 increase in non-cash stock
compensation, as noted below.
We reported a loss from operations of $12,929,000, which includes $4,112,000 of non-cash stock
based compensation, for the nine months ended September 30, 2010 compared with a loss from
operations of $13,228,000, which includes $4,159,000 of non-cash stock based compensation, in the
same period of 2009. The decrease in loss of $299,000, or 2%, was due primarily to a decrease of
$367,000 in research and development expenses and a $47,000 decrease in non-cash stock compensation
offset by a $115,00 increase in general and administrative expenses, as noted below.
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For the three months ended September 30, 2010, our net loss was approximately $4,135,000
compared with a net loss of $2,987,000 for the three months ended September 30, 2009. The increase
in net loss of $1,148,000, or 38%, includes the decrease in the loss from operations of $263,000
and an increase of $1,415,000 of other expenses related to $996,000 of non-cash other income
related to the change in fair value of common stock warrants from general and administrative
expenses to other income. The result is a net loss per share of $0.23 and $0.19, for the three
months ended September 30, 2010 and 2009, respectively. Reasons for the variations in the losses
between the two periods are discussed below.
For the nine months ended September 30, 2010, our net loss was approximately $10,162,000
compared with a net loss of $12,239,000 for the nine months ended September 30, 2009. The decrease
in net loss of $2,077,000, or 17%, includes the decrease in loss from operations of $299,000 and an
increase in other income of $1,770,000 in non-cash other income related to the change in fair value
of warrants issued with several financing transactions. The result is a net loss per share of
$0.57 and $0.85, for the nine months ended September 30, 2010 and 2009, respectively. Reasons for
the variations in the losses between the two periods 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.
Total research and development expenses were approximately $1,936,000 for the three months
ended September 30, 2010, compared with $2,091,000 for the three months ended September 30, 2009.
The decrease of $155,000 or 7%, was primarily due to a decrease of
$339,000 in research and
development cash expenses related to the timing of patent application and prosecution on internal
discoveries offset by an increase in costs associated with non-employee non-cash stock based
compensation of $129,000 and employee non-cash stock based compensation of $55,000 due to an
increase in fair value and additional option grants in 2010.
Total research and development expenses were approximately $6,126,000 for the nine months
ended September 30, 2010, compared with $6,533,000 for the nine months ended September 30, 2009.
The decrease of $407,000 or 6% was primarily due to a decrease of $223,000 in non-employee non-cash
stock based compensation and $367,000 decrease in research and development cash expenses related to
the timing of patent application and prosecution on internal discoveries offset by an increase of
$183,000 in costs associated with employee non-cash stock based compensation.
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 $1,783,000 for the three months ended
September 30, 2010, compared with $1,891,000 for the three months ended September 30, 2009. The
decrease of $108,000, or 5.7%, was primarily due to a $151,000 increase due to non-cash stock based
compensation expense. Excluding these non-cash items, general and administrative expenses were
approximately $1,126,000 for the three months ended September 30, 2010, compared with $1,385,000
for the three months ended September 30, 2009. The decrease of $259,000 was primarily due to a
reduction in professional fees.
General and administrative expenses were approximately $6,803,000 for the nine months ended
September 30, 2010, compared with $6,695,000 for the nine months ended September 30, 2009. The
increase of $108,000, or 2%, was primarily due to a decrease of $115,000 in general and
administrative expenses offset by a $7,000 decrease in non-cash stock based compensation due to a
decrease in warrants issued during 2010 as well as to the expensing of shares related to the SEDA.
Excluding these non-cash items, general and administrative expenses were approximately $4,228,000
for the nine months ended September 30, 2010, compared with $4,113,000 for the nine
months ended September 30, 2009. The increase of $115,000 was primarily due to an increase in
headcount and professional services fees.
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Interest Income
Interest income was negligible for the three and nine months ended September 30, 2010 and
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 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.
Other Income/Expense
Other income and expense for the three months ended September 30, 2010 includes $419,000 in
non-cash expense related to a loss on the change in the fair value of common stock warrants issued
in connection with several financing transactions in 2009 and 2010.
Other income and expense for the nine months ended September 30, 2010 includes $2,762,000 in
non-cash income related to a gain on the change in the fair value of common stock warrants issued
in connection with several financing transactions in 2009 and 2010. The fair value of the warrants
at September 30, 2010 of $3,425,000 is included as a current liability in the accompanying balance
sheets and was determined by the Black-Scholes option pricing model.
Liquidity and Capital Resources
During 2009 and to date in 2010, we have entered into the following significant financing
transactions:
On January 30, 2009, we entered into the SEDA, pursuant to which we may, at our option
over a two-year period, ending on January 30, 2011, periodically sell to YA Global shares of our
common stock, for a total purchase price of up to $25.0 million. To date we have not sold any
shares under the SEDA.
On August 4, 2009, we closed the 2009 Offering in which we sold 2,385,715 shares of our
common stock and warrants to purchase 954,286 shares of our common stock at an exercise price of
$4.50 per share resulting in approximately $7.8 million in net proceeds after deducting the
placement agent fee and offering expenses.
On March 26, 2010, we closed the 2010 Offering pursuant to which we sold to certain
investors 2,700,000 units for $6.00, which consisted of one share of common stock and a warrant to
purchase .20 shares of common stock with an exercise price of $6.00 per share. The financing
provided approximately $15.2 million in net proceeds to us after deducting the placement agent fee
and offering expenses. Pursuant to a stock redemption agreement between us and CytRx dated March
22, 2010, we were required to use 25% of the net proceeds from the 2010 Offering to repurchase from
CytRx a number of shares of our common stock held by CytRx equal to 25% of the shares sold by us in
the 2010 Offering. We are also required to use 25% of the proceeds from the exercise of warrants
issued in the 2010 Offering to repurchase from CytRx a number of shares of our common stock held by
CytRx equal to 25% of the shares issued upon the exercise of such warrants. As required by the
agreement with CytRx, on March 29, 2010, we repurchased 675,000 shares of our common stock from
CytRx for an aggregate price of approximately $3.8 million. We estimate that we will repurchase an
additional 135,000 shares of our common stock from CytRx for an aggregate price of $0.8 million if
all of the warrants issued in the offering are exercised.
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 for the foreseeable future while
we advance our future product candidates from discovery through pre-clinical studies and clinical
trials and seek regulatory approval and potential commercialization, even if we are collaborating
with pharmaceutical and larger biotechnology companies. In addition to these increasing research
and development expenses, we expect general and administrative costs to increase as we recruit
additional management and administrative personnel.
We believe that our existing cash and short-term investments should be sufficient to fund
our operations through at least the first half of 2011. In addition, we also have funds available
to us upon the issuance of shares of our common stock under the SEDA which expires on January 30,
2011. In the future, we will be dependent on obtaining
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funding from third parties such as proceeds from the sale of equity, funded research and
development payments, government and private grants and payments under partnership and
collaborative agreements, in order to maintain our operations and meet our obligations to
licensors. There is no guarantee that debt, additional equity or other funding will be available to
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
Cash used in operating activities is adjusted for non-cash items to reconcile net loss to net
cash used in or provided by operating activities. These non-cash adjustments consist primarily of
stock based compensation, change in fair value of common stock warrants issued in connection with
various equity financings potentially settleable in cash, and depreciation and amortization. Net
cash used in operating activities was approximately $8,388,000 for the nine months ended September
30, 2010, compared with $8,481,000 for the nine months ended September 30, 2009. Cash used in
operations in 2010 consisted primarily from a net loss of $10,162,000, less the add back of
non-cash items of $1,471,000, of which $2,762,000 related to the change in fair value of common
stock warrants issued in connection with various equity financings, $3,458,000 related to non-cash
stock based compensation, $654,000 related to common stock warrant expense in exchange for
services, $127,000 related to depreciation and amortization expense, $6,000 related to accretion
and receipt of bond and $303,000 related to changes in current assets and liabilities.
We expect that we will require significant amounts of cash to fund our operating activities
for the foreseeable future as we continue to develop and advance our research and development
initiatives. The actual amount of overall expenditures will depend on numerous factors, including
the timing of expenses, the timing and terms of collaboration and or agreements or other strategic
transactions, if any, and the timing and progress of our research and development efforts.
Net Cash Flow from Investing Activities
Net cash used in investing activities was approximately $6,055,000 for the nine months ended
September 30, 2010, compared with net cash used in investing activities of $83,000 for the nine
months ended September 30, 2009. The increase of approximately $5,972,000 in cash used in investing
activities was primarily due to the purchase of United States Treasury notes in the second quarter
of 2010, combined with the purchase of new equipment in the second and third quarters of 2010.
Net Cash Flow from Financing Activities
Net cash provided by financing activities was $11,595,000 for the nine months ended September
30, 2010, compared with net cash provided by financing of $7,696,000 for the nine months ended
September 30, 2009. Cash provided in 2010 and 2009 was primarily due to net proceeds from the
issuance of common stock to institutional investors in the first quarter of 2010 and the third
quarter of 2009, respectively.
We have not entered into off-balance sheet financing, other than operating leases, license
agreements and the SEDA.
Critical Accounting Policies and Estimates
In our Annual Report on Form 10-K for the year ended December 31, 2009, 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, 2009. 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, 2010 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, 2010, filed on August 16, 2010 with the SEC.
ITEM 2. | UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS |
None
ITEM 3. | DEFAULTS UPON SENIOR SECURITIES |
None
ITEM 4. | RESERVED |
ITEM 5. | OTHER INFORMATION |
None
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ITEM 6. | EXHIBIT |
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) | |
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 |
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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
|
|||||
President and Chief Executive Officer |
||||||
(Principal Executive Officer) | ||||||
By: | /s/ Amy B. Tata
|
|||||
Principal Accounting Officer and Controller | ||||||
(Principal Accounting Officer) |
||||||
Date: November 15, 2010 |
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