SELLAS Life Sciences Group, Inc. - Quarter Report: 2010 March (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 March 31, 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 May 15, 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 MARCH 31, 2010
FORM 10-Q QUARTER ENDED MARCH 31, 2010
INDEX
Part No. | Item No. | Description | Page No. | |||||
I | ||||||||
1 | 3 | |||||||
3 | ||||||||
4 | ||||||||
5 | ||||||||
7 | ||||||||
2 | 13 | |||||||
4 | 17 | |||||||
II | 18 | |||||||
1 | 18 | |||||||
1A | 18 | |||||||
2 | 18 | |||||||
3 | 18 | |||||||
4 | 18 | |||||||
5 | 18 | |||||||
6 | 18 | |||||||
Index to Exhibits | 18 | |||||||
Signatures | 19 | |||||||
EX-31.1 | ||||||||
EX-31.2 | ||||||||
EX-32.1 |
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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)
March 31, | December 31, | |||||||
2010 | 2009 | |||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 14,854 | $ | 5,684 | ||||
Prepaid expenses and other current assets |
460 | 120 | ||||||
Total current assets |
15,314 | 5,804 | ||||||
Equipment and furnishings, net |
432 | 432 | ||||||
Deposits |
16 | 16 | ||||||
Total assets |
$ | 15,762 | $ | 6,252 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 1,121 | $ | 625 | ||||
Accrued expenses and other current liabilities |
1,226 | 1,077 | ||||||
Current maturities of capital lease obligations |
51 | 52 | ||||||
Fair value
of common stock mandatorily redeemable for cash upon the
exercise of warrants |
785 | | ||||||
Fair value of warrants potentially settleable in cash |
5,616 | 3,721 | ||||||
Total current liabilities |
8,799 | 5,475 | ||||||
Capital lease obligations, net of current maturities |
52 | 36 | ||||||
Total liabilities |
8,851 | 5,511 | ||||||
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;19,033,339 shares issued and 18,358,339 shares
outstanding and 16,207,625 shares issued and outstanding at
March 31, 2010 and December 31, 2009, respectively |
3 | 2 | ||||||
Additional paid-in capital |
58,393 | 44,489 | ||||||
Deficit accumulated during the developmental stage |
(47,636 | ) | (43,750 | ) | ||||
Less treasury shares at cost, 675,000 and 0 shares at March
31, 2010 and December 31, 2009, respectively |
3,849 | | ||||||
Total stockholders equity |
6,911 | 741 | ||||||
Total liabilities and stockholders equity |
$ | 15,762 | $ | 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 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 | (Date of | ||||||||||
Months Ended | Months Ended | Inception) to | ||||||||||
March 31, | March 31, | March 31, | ||||||||||
2010 | 2009 | 2009 | ||||||||||
Expenses: |
||||||||||||
Research and development expense |
$ | 1,499 | $ | 1,194 | $ | 22,136 | ||||||
Research and development employee stock-based compensation
expense |
273 | 200 | 1,596 | |||||||||
Research and development non-employee stock-based
compensation expense |
154 | 22 | 5,474 | |||||||||
Fair value of common stock in exchange for licensing rights |
| | 3,954 | |||||||||
Total research and development expenses |
1,926 | 1,416 | 33,160 | |||||||||
General and administrative |
1,448 | 1,303 | 17,065 | |||||||||
General and administrative employee stock-based compensation |
772 | 437 | 1,886 | |||||||||
Common stock warrants issued for general and administrative
expenses |
310 | 734 | 5,616 | |||||||||
Fair value of common stock issued in exchange for general
and administrative expenses |
| 281 | 281 | |||||||||
Total general and administrative expenses |
2,530 | 2,755 | 24,848 | |||||||||
Operating loss |
(4,456 | ) | (4,171 | ) | (58,008 | ) | ||||||
Interest income (expense) |
(1 | ) | | 622 | ||||||||
Other income (expense) |
571 | | (291 | ) | ||||||||
Net loss |
$ | (3,886 | ) | $ | (4,171 | ) | $ | (57,677 | ) | |||
Net loss per common share: |
||||||||||||
Basic and diluted loss per share |
$ | (0.24 | ) | $ | (0.30 | ) | N/A | |||||
Weighted average common shares outstanding: |
||||||||||||
Basic and diluted |
16,386,435 | 13,802,812 | 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 Three | For the Three | Inception) | ||||||||||
Months Ended | Months Ended | through | ||||||||||
March 31, | March 31, | March 31, | ||||||||||
2010 | 2009 | 2010 | ||||||||||
Cash flows from operating activities: |
||||||||||||
Net loss |
$ | (3,886 | ) | $ | (4,171 | ) | $ | (57,677 | ) | |||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||||||
Depreciation and amortization expense |
42 | 38 | 371 | |||||||||
Loss on disposal of equipment |
| | 12 | |||||||||
Non-cash rent expense |
| | 29 | |||||||||
Accretion and receipt of bond discount |
| | 35 | |||||||||
Non-cash share-based compensation |
1,199 | 659 | 12,688 | |||||||||
Fair value of common stock warrants issued in exchange for services |
310 | 734 | 1,886 | |||||||||
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 |
(571 | ) | | 287 | ||||||||
Fair value of common stock issued in exchange for licensing rights |
| | 3,954 | |||||||||
Changes in assets and liabilities: |
||||||||||||
Prepaid expenses |
(340 | ) | (318 | ) | (460 | ) | ||||||
Accounts payable |
496 | 15 | 1,121 | |||||||||
Due to former parent |
| | (207 | ) | ||||||||
Accrued expenses and other current liabilities |
306 | 90 | 1,383 | |||||||||
Net cash used in operating activities |
(2,444 | ) | (2,672 | ) | (36,297 | ) | ||||||
Cash flows from investing activities: |
||||||||||||
Purchase of short-term investments |
| | (31,542 | ) | ||||||||
Maturities of short-term investments |
| | 31,507 | |||||||||
Cash paid for purchase of equipment and furnishings |
(14 | ) | (8 | ) | (595 | ) | ||||||
Cash paid for lease deposit |
| | (45 | ) | ||||||||
Net cash used in investing activities |
(14 | ) | (8 | ) | (675 | ) | ||||||
Cash flows from financing activities: |
||||||||||||
Net proceeds from issuance of common stock |
15,235 | | 46,367 | |||||||||
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 |
(13 | ) | (4 | ) | (69 | ) | ||||||
Cash advances from former parent company, net |
| | 8,766 | |||||||||
Net cash provided by (used in) financing activities |
11,628 | (4 | ) | 51,826 | ||||||||
Net increase (decrease) in cash and cash equivalents |
9,170 | (2,684 | ) | 14,854 | ||||||||
Cash and cash equivalents at the beginning of period |
5,684 | 9,856 | | |||||||||
Cash and cash equivalents at end of period |
$ | 14,854 | $ | 7,172 | $ | 14,854 | ||||||
Supplemental disclosure of cash flow information: |
||||||||||||
Cash received during the period for interest |
$ | 1 | $ | | $ | 725 | ||||||
Cash paid during the period for interest |
$ | | $ | 1 | $ | 7 | ||||||
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Period from | ||||||||||||
January 1, 2003 | ||||||||||||
(Date of | ||||||||||||
For the Three | For the Three | Inception) | ||||||||||
Months Ended | Months Ended | through | ||||||||||
March 31, | March 31, | March 31, | ||||||||||
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 | $ | | $ | 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 |
$ | 28 | $ | | $ | 172 | ||||||
Value of restricted stock units issued in lieu of
bonuses included in accrued expenses |
$ | 157 | $ | | $ | 157 | ||||||
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 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
March 31, 2010, 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, 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 month periods ended March 31, 2010 and 2009, as well as the cumulative
financial information for the period from January 1, 2003 (date of inception) through March 31,
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.
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.
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.
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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 in certain events, as defined.
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. 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 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 three month period ended March 31,
2010 and 2009, the following assumptions were used:
2010 | 2009 | |||||||
Weighted average risk-free interest rate |
2.79 | % | 1.88 | % | ||||
Weighted average expected volatility |
111.61 | % | 117.85 | % | ||||
Weighted average expected lives (years) |
5.94 | 6.86 | ||||||
Weighted average expected dividend yield |
0.00 | % | 0.00 | % |
The weighted average fair value of options granted during the three month period ended March
31, 2010 and 2009 was $4.95 and $3.74 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
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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.
The following table summarizes stock option activity from January 1, 2010 through March 31,
2010:
Total Number | Weighted Average | Aggregate | ||||||||||
of Shares | Exercise Price | Intrinsic Value | ||||||||||
Outstanding at January 1, 2010 |
3,582,339 | $ | 5.16 | $ | 1,240,110 | |||||||
Granted |
622,440 | 5.63 | | |||||||||
Exercised |
53,500 | 4.75 | 163,889 | |||||||||
Cancelled |
| | | |||||||||
Outstanding at March 31, 2010 |
4,151,279 | $ | 5.24 | $ | 1,234,005 | |||||||
Options exercisable at March 31, 2010 |
2,322,928 | $ | 5.42 | $ | 196,999 | |||||||
The aggregate intrinsic values of outstanding and exercisable options at March 31, 2010 were
calculated based on the closing price of the Companys common stock on March 31, 2010 of $4.56 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.
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:
March 31, | ||||||||
2010 | 2009 | |||||||
Options to purchase common stock |
4,151,279 | 3,094,608 | ||||||
Warrants to purchase common stock |
2,100,642 | 332,500 | ||||||
Total |
6,251,921 | 3,427,108 | ||||||
4. 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 the sales.
The expenditures
required under the licensing 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
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same period, the aggregate charge to expense could be material to the results of operations.
In addition, these licensing 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
licensing agreements that will require future
cash payments relating to minimum annual maintenance fees and
milestone payments have not changed
significantly from December 31, 2009
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 and its common stock potentially redeemable 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. The common stock is measured at market value and discounted to present value on a recurring
basis each quarter until they are completely settled. 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 the first quarter of 2011.
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
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 and 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 31, 2010. The value of the shares at the date of
repurchase totaling $3,849,000 were recorded at cost and has been included in treasury stock in the
accompanying balance sheets at March 31, 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. Subject to
the satisfaction of certain closing conditions, if any warrant issued in the 2010 Offering is
exercised, on the first business day after the exercise of such warrant.
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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, shall be
classified as a liability. The fair value of the common stock
potentially redeemed under the stock
redemption agreement totaling $785,000 was recorded as a liability and a cost of equity and was
determined by the present value of the amount of cash that would be paid under the conditions
specified in the stock redemption agreement, if all of the shares required to be redeemed were
repurchased immediately as we currently believe that the warrant
shares will be exercised when they become exerciseable in
September 2010.
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
we have 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 increase in the
fair value of the warrants from the date of issuance to March 31, 2010 is $328,000 and has been
included in other income and expense in the accompanying condensed statements of expenses for the
three months ended March 31, 2010. The fair value of the warrants at March 31, 2010 of $2,138,000
is included as a current liability in the accompanying balance sheets 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 119.66%. 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 we have no present intention to
pay cash dividends. The risk free rate of 3.18% used for the warrant is equal to the zero coupon
rate in effect on the date of the re-measurement.
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. 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 increase in the fair value of the warrants from
the date of issuance to March 31, 2010 is $615,000 of which $244,000 has been included in other
income and expense in the accompanying condensed statements of expenses for the three months ended
March 31, 2010. The fair value of the warrants at March 31, 2010 of $3,478,000 is included as a
current liability in the accompanying balance sheets 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 119.66%. The expected life assumption is based on the contract term of 4 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 2.09% used for the warrant is equal to the zero coupon rate in effect on the date
of the re-measurement.
7. Recent Accounting Pronouncements
In June 2009, the FASB issued FASB ASC Topic 810-10, Consolidations, (ASC 860-10), which
amends the consolidation guidance applicable to variable interest entities and is 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
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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.
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 adoption of ASC 820-10-65, ASC 320-10-65, and 825-10-65 did not have a material
impact on the Companys financial statements.
8. Subsequent Events
On April
15, 2010, the Company granted options to purchase 60,000 shares
of common stock to certain employees. These options had an exercise
price of $4.41 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.
Management has evaluated subsequent events and the impact on the reported results and
disclosures.
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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 March 31, 2010 and
results of operations for the three months ended March 31, 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, or 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 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 discovery research and
pre-clinical development activities utilizing the Companys RNAi therapeutic platform, acquiring
RNAi technologies and patent rights through exclusive, co-exclusive and non-exclusive licenses,
recruiting an RNAi-focused management and scientific/clinical advisory team, 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 and payments
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under partnership and collaborative agreements. As the Company has not generated any revenues
since inception through March 31, 2010, we are considered a development stage company for
accounting purposes.
We believe that our existing cash 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 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 Months ended March 31, 2010, and March 31, 2009
For the three months ended March 31, 2010, our net loss was approximately $3,886,000 compared
with a net loss of $4,171,000 for the three months ended March 31, 2009. The loss decreased by
$285,000, or approximately 7%. 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 $1,926,000 for the three months
ended March 31, 2010, compared with $1,416,000 for the three months ended March 31, 2009. The
increase of $510,000 or 36% was primarily due to an increase of $132,000 in non-employee, non-cash
share based compensation , as well as, increases in costs associated with employee compensation,
including an increase in employee non-cash share based compensation of $73,000, 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 $2,530,000 for the three months ended
March 31, 2010, compared with $2,755,000 for the three months ended March 31, 2009. The decrease of
$225,000, or 8% was primarily due to a $335,000 increase in non-cash share based compensation and a
$705,000 decrease due to non-cash compensation expense related to a warrant issued for business
advisory services as well as the fair value of common stock issued as a commitment fee for the SEDA
for the three months ended March 31, 2009. Excluding these non-cash items general and
administration expense were approximately $1,448,000 for the three months ended March 31, 2010,
compared with $1,303,000 for the three months ended March 31, 2009, 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 March 31, 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.
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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 includes $571,000 related to a gain on the change in the fair value
of warrants issued in connection with financing activities.
Operating Results
We reported a loss from operations of $4,456,000 for the three months ended March 31, 2010
compared with a loss from operations of $4,171,000 in 2009. The increase in loss of $285,000, or
7%, was due primarily to increased expenses related to non-cash equity compensation, as noted
above.
We reported a net loss of $3,886,000 for the three months ended March 31, 2010, compared with
a net loss of $4,171,000 in 2009. The decrease in net loss of
$285,000, or 7%, equaled a net loss
per share of $0.24 and $0.30, for the three months ended March 31, 2010 and 2009, respectively.
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 0.20 shares of common stock with an exercise price of $6.00 per share. The financing
provided approximately $15.2 million in net proceeds to the Company 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 had not generated any revenues since inception nor are any revenues expected
for the foreseeable future. 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 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 funding 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 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.
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Net Cash Flow from Operating Activities
Net cash used in operating
activities was approximately $2,444,000 for the three months ended
March 31, 2010, compared with $2,672,000 for the three months ended March 31, 2009. The decrease of
approximately $228,000 resulted primarily from a net loss of $3,886,000, less the add back of
non-cash items of $980,000, of which $1,199,000 related to stock-based compensation, $310,000
related to stock warrant expense in exchange for services, $42,000 related to depreciation and
amortization expense and $462,000 related to changes in current assets and liabilities.
Net Cash Flow from Investing Activities
Net cash used in investing activities was approximately $14,000 for the three months ended
March 31, 2010, compared with net cash used in investing activities of $8,000 for the three months
ended March 31, 2009. The increase of approximately $6,000 in cash used in investing activities was
primarily due to the purchase of new equipment in the first quarter of 2010.
Net Cash Flow from Financing Activities
Net cash provided by financing activities was $11,628,000 for the three months ended March 31,
2010, compared with net cash used in financing of $4,000 for the three months ended March 31, 2009.
This increase was primarily due to net proceeds from the issuance of common stock to institutional
investors in the first quarter of 2010. There were no such financing activities in the first
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, 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 March 31, 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 carefully review and consider the Risk Factors included under Item 1A. of our annual
report on Form 10-K for the year ended December 31, 2009, filed on March 31, 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
ITEM 6. EXHIBITS
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 | |||
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: May 17, 2010 |
||||
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