SELLAS Life Sciences Group, Inc. - Quarter Report: 2009 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, 2009
OR
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File number 001-33958
RXi Pharmaceuticals Corporation
(Exact name of registrant as specified in its charter)
Delaware | 20-8099512 | |
(State of incorporation) | (I.R.S. Employer Identification No.) |
60 Prescott Street, Worcester, MA 01605
(Address of principal executive office) (Zip code)
(Address of principal executive office) (Zip code)
Registrants telephone number: (508) 767-3861
Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the Registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days.
Yes þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and
posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period 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 (Do not check if a smaller reporting company) | Smaller reporting company þ |
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 11, 2009, RXi Pharmaceuticals Corporation had 13,821,629 shares of common stock, $0.0001
par value, outstanding.
RXi PHARMACEUTICALS CORPORATION
FORM 10-Q QUARTER ENDED March 31, 2009
FORM 10-Q QUARTER ENDED March 31, 2009
INDEX
Table of Contents
PART I
ITEM 1. FINANCIAL STATEMENTS
RXi PHARMACEUTICALS CORPORATION
(A Development Stage Company)
(A Development Stage Company)
CONDENSED BALANCE SHEETS
(Amounts in thousands, except per share data)
(Unaudited)
(Amounts in thousands, except per share data)
(Unaudited)
March 31, | December 31, | |||||||
2009 | 2008 | |||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 7,172 | $ | 9,856 | ||||
Prepaid expenses and other current assets |
391 | 73 | ||||||
Total current assets |
7,563 | 9,929 | ||||||
Equipment and furnishings, net |
384 | 414 | ||||||
Deposits |
16 | 16 | ||||||
Total assets |
$ | 7,963 | $ | 10,359 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 409 | $ | 394 | ||||
Accrued expense and other current liabilities |
1,066 | 976 | ||||||
Current maturities of capital lease obligations |
17 | 17 | ||||||
Total current liabilities |
1,492 | 1,387 | ||||||
Capital lease obligations, net of current maturities |
| 4 | ||||||
Total liabilities |
1,492 | 1,391 | ||||||
Commitments and contingencies |
||||||||
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; 13,821,629 and
13,763,231shares issued and outstanding at March
31, 2009 and December 31, 2008, respectively |
1 | 1 | ||||||
Additional paid-in capital |
36,004 | 34,330 | ||||||
Deficit accumulated during the developmental stage |
(29,534 | ) | (25,363 | ) | ||||
Total stockholders equity |
6,471 | 8,968 | ||||||
Total liabilities and stockholders equity |
$ | 7,963 | $ | 10,359 | ||||
The accompanying notes are an integral part of these financial statements.
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RXi PHARMACEUTICALS CORPORATION
(A Development Stage Company)
(A Development Stage Company)
CONDENSED STATEMENTS OF EXPENSES
(Amounts in thousands, except per share data)
(Unaudited)
(Amounts in thousands, except 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, | ||||||||||
2009 | 2008 | 2009 | ||||||||||
Expenses: |
||||||||||||
Research and development expense |
$ | 1,194 | $ | 882 | $ | 15,103 | ||||||
Research and development
employee stock-based
compensation expense |
200 | 40 | 656 | |||||||||
Research and development
non-employee stock-based
compensation expense |
22 | 166 | 4,045 | |||||||||
Fair value of common stock
issued in exchange for
licensing rights |
| | 3,954 | |||||||||
Total research and development
expenses |
1,416 | 1,088 | 23,758 | |||||||||
General and administrative |
1,303 | 1,210 | 11,437 | |||||||||
Common stock warrants issued
for general and administrative
expenses |
734 | | 1,484 | |||||||||
Common stock issued for general
and administrative expenses |
281 | | 281 | |||||||||
General and administrative
employee stock-based
compensation |
437 | 423 | 3,243 | |||||||||
Total general and
administrative expenses |
2,755 | 1,633 | 16,445 | |||||||||
Operating loss |
(4,171 | ) | (2,721 | ) | (40,203 | ) | ||||||
Interest income |
| 75 | 628 | |||||||||
Net loss |
$ | (4,171 | ) | $ | (2,646 | ) | $ | (39,575 | ) | |||
Net loss per common share: |
||||||||||||
Basic and diluted loss per share |
$ | (0.30 | ) | $ | (0.21 | ) | N/A | |||||
Weighted average common shares
outstanding: |
||||||||||||
Basic and diluted |
13,802,812 | 12,684,432 | N/A | |||||||||
The accompanying notes are an integral part of these financial statements.
4
Table of Contents
RXi PHARMACEUTICALS CORPORATION
(A Development Stage Company)
(A Development Stage Company)
STATEMENTS OF CASH FLOWS
(Amounts in thousands, except per share data)
(Unaudited)
(Amounts in thousands, except per share data)
(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, | ||||||||||
2009 | 2008 | 2009 | ||||||||||
Cash flows from operating activities: |
||||||||||||
Net loss |
$ | (4,171 | ) | $ | (2,646 | ) | $ | (39,575 | ) | |||
Adjustments to reconcile net loss to net cash used in operating
activities: |
||||||||||||
Depreciation and amortization expense |
38 | 29 | 205 | |||||||||
Loss on disposal of equipment |
| 8 | 8 | |||||||||
Non-cash rent expense |
| 29 | 29 | |||||||||
Accretion and receipt of bond discount |
| 172 | 35 | |||||||||
Non -cash share-based compensation |
659 | 629 | 7,946 | |||||||||
Fair value of common stock warrants issued in exchange for
services |
734 | | 1,484 | |||||||||
Fair value of common stock issued in exchange for services |
281 | | 281 | |||||||||
Fair value of common stock issued in exchange for licensing rights |
| | 3,954 | |||||||||
Changes in assets and liabilities: |
||||||||||||
Prepaid expenses |
(318 | ) | (300 | ) | (391 | ) | ||||||
Accounts payable |
15 | 185 | 409 | |||||||||
Due to former parent |
| (140 | ) | (207 | ) | |||||||
Accrued expenses and other current liabilities |
90 | 366 | 1,066 | |||||||||
Net cash used in operating activities |
(2,672 | ) | (1,668 | ) | (24,756 | ) | ||||||
Cash flows from investing activities: |
||||||||||||
Purchase of short-term investments |
| | (31,542 | ) | ||||||||
Maturities of short-term investments |
| 9,780 | 31,507 | |||||||||
Cash paid for purchase of equipment and furnishings |
(8 | ) | (18 | ) | (506 | ) | ||||||
Cash paid for lease deposit |
| | (45 | ) | ||||||||
Net cash provided by (used in) investing activities |
(8 | ) | 9,762 | (586 | ) | |||||||
Cash flows from financing activities: |
||||||||||||
Net proceeds from issuance of common stock |
| | 23,418 | |||||||||
Net proceeds from exercise of common stock options |
| | 356 | |||||||||
Repayments of capital lease obligations |
(4 | ) | | (26 | ) | |||||||
Cash advances from former parent company, net |
| | 8,766 | |||||||||
Net cash provided by (used in) financing activities |
(4 | ) | | 32,514 | ||||||||
Net increase (decrease) in cash and cash equivalents |
(2,684 | ) | 8,094 | 7,172 | ||||||||
Cash and cash equivalents at the beginning of period |
9,856 | 1,763 | | |||||||||
Cash and cash equivalents at end of period |
$ | 7,172 | $ | 9,857 | $ | 7,172 | ||||||
Supplemental disclosure of cash flow information: |
||||||||||||
Cash received during the period for interest |
$ | | $ | 247 | $ | 723 | ||||||
Cash paid during the period for interest |
$ | 1 | $ | | $ | 7 | ||||||
Supplemental disclosure of non-cash investing and financing
activities: |
||||||||||||
Settlement of corporate formation expenses in exchange for common
stock |
$ | | $ | | $ | 978 | ||||||
Allocation of management expenses |
$ | | $ | | $ | 551 | ||||||
Equipment and furnishings exchanged for common stock |
$ | | $ | | $ | 48 | ||||||
Acquisition of equipment and furnishings through accrued
liabilities |
$ | | $ | 39 | $ | | ||||||
Equipment and furnishings acquired through capital lease |
$ | | $ | | $ | 43 | ||||||
Non-cash lease deposit |
$ | | $ | | $ | 50 | ||||||
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)
NOTES TO CONDENSED FINANCIAL STATEMENTS
March 31, 2009
(Unaudited)
(Unaudited)
1. Description of Business and Basis of Presentation
RXi Pharmaceuticals Corporation (RXi or the Company) was formed by CytRx Corporation
(CytRx or the Former Parent) and four prominent RNAi researchers, including Craig C. Mello,
Ph.D., who was awarded the 2006 Nobel Prize in Medicine for his co-discovery of RNA interference
(RNAi). The purpose of forming RXi was to pursue the development of proprietary therapeutics based
on RNAi for the treatment of human diseases. By utilizing the Companys expertise in RNAi and the
RNAi technology 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.
In 2003, CytRx entered into several technology license agreements with the University of
Massachusetts Medical School (UMMS), related to RNAi technologies. CytRx subsequently entered
into other RNAi-related technology agreements. These assets were contributed to RXi in the first
quarter of 2007. From April 3, 2006 (date of incorporation) until January 8, 2007, no business was
conducted at the RXi level. On January 8, 2007, RXi entered into a contribution agreement with
CytRx under which CytRx assigned and contributed to RXi substantially all of its RNAi-related
technologies and assets and commenced operations; these contributed assets were recorded by RXi at
the historical cost basis of $48,000.
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 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, 2009, the
Company is considered a development-stage company for accounting purposes. On January 30, 2009, the
Company entered into Standby Equity Distribution Agreement (the SEDA) with YA Global Master SPV
Ltd. (YA Global) pursuant to which the Company may, at its sole and exclusive option,
periodically sell to YA Global shares of RXi common stock, for a total purchase price of up to
$25,000,000. The Company believes that its existing cash, cash equivalents and potential proceeds
from the SEDA are sufficient to fund operations through at least the first half of 2010. In the
future, the Company will be dependent on obtaining funding from third parties in order to maintain
its operations. There is no guarantee that additional debt, 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 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. In addition to these increasing
research and development expenses, the Company 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.
The accompanying condensed financial statements have been prepared in accordance with the
rules and regulations of the Securities and Exchange Commission (SEC) and should be read in
conjunction with the Companys financial statements and the notes thereto for the year ended
December 31, 2008 included in the Companys Annual Report on Form 10-K filed with the SEC on March
18, 2009. Certain information and footnote disclosures normally included in financial statements
prepared in accordance with United States generally accepted accounting principles 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, 2009 and 2008, as well as the cumulative financial
information for the period from January 1, 2003 (date of inception) through March 31, 2009, is
unaudited and has
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RXi PHARMACEUTICALS CORPORATION
(A Development Stage Company)
(A Development Stage Company)
NOTES TO CONDENSED FINANCIAL STATEMENTS
March 31, 2009
been prepared on the same basis as the audited financial statements and includes all
adjustments, consisting of only normal recurring adjustments, necessary for the fair presentation
of this information in all material respects. The results of any interim period are not necessarily
indicative of the results of operations to be expected for a full fiscal year. There have been no
material changes to the Companys significant accounting policies as disclosed in the Companys
Annual Report on Form 10-K for the year ended December 31, 2008.
Uses of estimates in preparation of financial statements
The preparation of financial statements in accordance with accounting principles generally
accepted in the United States of America requires management to make estimates and assumptions that
affect the reported amounts of assets and liabilities and disclosure of contingent assets and
liabilities at the date of the financial statements and the reported amounts of revenues and
expenses during the reporting period. Actual results could differ from these estimates.
Reclassifications
Certain prior year amounts have been reclassified to conform with the current years
presentation.
2. Stock Based Compensation
RXi follows the provisions of Statement of Financial Accounting Standards (SFAS) SFAS 123(R)
Share-Based Payments. SFAS No. 123(R) 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 SFAS No. 123(R) 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 SFAS No. 123(R), Emerging
Issues Task Force (EITF) Issue No. 96-18, Accounting for Equity Instruments that are Issued to
Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services and EITF
Issue No. 00-18 Accounting Recognition for Certain Transactions involving Equity Instruments
Granted to Other Than Employees, as amended.
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,
2009 and 2008, the following assumptions were used:
2009 | 2008 | |||||||
Risk-free interest rate |
1.55% - 2.71 | % | 2.567 | % | ||||
Expected volatility |
116.72% - 120.58 | % | 106 | % | ||||
Expected lives (years) |
6 - 10 | 6 | ||||||
Expected dividend yield |
0.00 | % | 0.00 | % |
The weighted average fair value of options granted during the three month period ended March
31, 2009 and 2008 was $3.74 and $5.00 per share, respectively.
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RXi PHARMACEUTICALS CORPORATION
(A Development Stage Company)
(A Development Stage Company)
NOTES TO CONDENSED FINANCIAL STATEMENTS
March 31, 2009
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 Staff Accounting Bulletin 107 (SAB 107), 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.
The following table summarizes stock option activity from January 1, 2009 through March 31,
2009:
Total Number | Weighted Average | |||||||
of Shares | Exercise Price | |||||||
Outstanding at January 1, 2009 |
2,223,452 | $ | 6.11 | |||||
Granted |
872,718 | 4.29 | ||||||
Cancelled |
1,562 | 5.00 | ||||||
Outstanding at March 31, 2009 |
3,094,608 | $ | 5.60 | |||||
Options exercisable at March 31, 2009 |
1,392,035 | $ | 5.63 | |||||
The aggregate intrinsic values of outstanding and exercisable options at March 31, 2009 were
calculated based on the closing price of the Companys stock on March 31, 2009 of $5.09 per share
less the exercise price of those shares. The total intrinsic value of outstanding stock options and
exercisable common stock options for the three months ended March 31, 2009 and 2008 was $828,000
and $143,000, and $6,458,000 and $2,833,000, respectively.
3. Stockholders Equity
On January 29, 2009, the Company issued 142,500 warrants to an investment bank as
consideration for investment and business advisory services. The warrants have an exercise price
of $4.273 per share and expire five years from the date of issuance on January 29, 2014. The
warrants vested as to 71,250 shares upon issuance, and then will vest at a rate of 23,750 shares
per month starting on the 90 day anniversary of issuance, and are exercisable for a period of five
years. The Company has also agreed to give the holder of the warrants unlimited piggy back
registration rights with respect to the shares of Common Stock underlying the Warrants in any
registration statement the Company files in connection with an underwritten offering of the common
stock. The fair value of these warrants has been estimated based on the Black-Scholes options
pricing model and changes in the fair value are recorded in the condensed statement of expenses in
accordance with the requirements of SFAS No. 123(R), EITF Issue No. 96-18, and EITF Issue No.
00-18. Total expense related to these warrants was approximately $416,000 during the three months
ended March 31, 2009.
On January 30, 2009, the Company entered into the SEDA with YA Global pursuant to which the
Company may, at its sole and exclusive option, periodically sell to YA Global shares of its common
stock for a total purchase price of up to $25,000,000. Advance notices may be given to YA Global
once every five trading days, and advances shall not be more than $500,000. The purchase price for
shares of common stock shall be 95% of the lowest volume weighted average price of the Common Stock
during the five consecutive trading days after the advance notice date. YA Global is not obligated
to fund any advance from the Company until such time as a registration statement which registers the resale of the shares of its common stock to be issued to YA Global is declared
effective by the SEC. The term of the SEDA is two years.
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RXi PHARMACEUTICALS CORPORATION
(A Development Stage Company)
(A Development Stage Company)
NOTES TO CONDENSED FINANCIAL STATEMENTS
March 31, 2009
The Company issued YA Global an aggregate of 58,398 shares of its common stock as a commitment
fee in connection with the transaction. RXi also paid to Yorkville Advisors, LLC, YA Globals
general partner (Yorkville), a due diligence and structuring fee of $25,000. In addition, we are
obligated to pay Yorkville a $500 structuring fee taken directly out of the gross proceeds of each
advance. Total expense related to the SEDA was approximately $306,000 of which $25,000 and $281,000
was expensed as general and administrative expense during the twelve months ended December 31, 2008
and the three months ended March 31, 2009, respectively.
4. Net Loss Per Share
The Company accounts for and discloses net loss per common share in accordance with SFAS No.
128, 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, | ||||||||
2009 | 2008 | |||||||
Options to purchase common stock |
3,094,608 | 1,435,184 | ||||||
Warrants to purchase common stock |
332,500 | | ||||||
Total |
3,427,108 | 1,435,184 | ||||||
5. License Agreements
As part of its business, the Company enters into significant licensing agreements. There have
been no material changes to the Companys license agreements as disclosed in the Companys Annual
Report on Form 10-K for the year ended December 31, 2008.
6. Fair Value Measurements
Effective January 1, 2008, the Company implemented SFAS No. 157, Fair Value Measurement, or
SFAS 157, 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. 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.
In accordance with the provisions of FSP No. FAS 157-2, Effective Date of FASB Statement No.
157,the Company has elected to defer implementation of SFAS 157 as it relates to its financial
assets and liabilities that are recognized and disclosed at fair value in the financial statements
on a nonrecurring basis until January 1, 2009. The Company is evaluating the impact, if any, this standard will have on its financial assets and
liabilities. The adoption of SFAS 157 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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RXi PHARMACEUTICALS CORPORATION
(A Development Stage Company)
(A Development Stage Company)
NOTES TO CONDENSED FINANCIAL STATEMENTS
March 31, 2009
7. Recent Accounting Pronouncements
In April 2009, the Financial Accounting Standards Board (FASB) issued three related Staff
Positions: (i) FSP 157-4, 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
or FSP 157-4, (ii) SFAS 115-2 and SFAS 124-2, Recognition and Presentation of Other-Than-Temporary
Impairment or FSP 115-2 and FSP 124-2, and (iii) SFAS 107-1 and APB 28-1, Interim Disclosures
about Fair Value of Financial Instruments or FSP 107 and APB 28-1, which will be effective for
interim and annual periods ending after June 15, 2009. FSP 157-4 provides guidance on how to
determine the fair value of assets and liabilities under SFAS 157 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. FSP 115-2 and FSP 124-2 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. FSP 107 and
APB 28-1 enhance the disclosure of instruments under the scope of SFAS 157 for both interim and
annual periods. We are currently evaluating these staff positions and the impact, if any, that
adoption will have on our financial position and results of operation.
8. Subsequent Events
On April 23, 2009, the Company granted options to purchase 60,500 shares of common stock to
employees and members of the board of directors. These options had an exercise price of $4.60 per
share, which is equal to the Companys closing stock price on that date. These options vest either
quarterly over a one to four year period and expire no later than 10 years from the grant date.
On May 4, 2009 the Company filed a Form S-3 registration statement. The registration
statement was filed to register the offer and sale by the Company from time to time of shares of
RXis common stock, shares of RXis preferred stock in one or more series, warrants to purchase
RXis common stock, preferred stock or debt securities, and the Companys debt securities which may
consist of notes, debentures or other types of debt. In addition, the registration statement was
filed to register the offer and sale by a selling stockholder from time to time of 500,000 shares
of the Companys common stock.
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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, 2009 and
results of operations for the three months ended March 31, 2009 and 2008 should be read in
conjunction with managements discussion and analysis of financial condition and results of
operations included in our Annual Report on Form 10-K for the year ended December 31, 2008.
The discussion and analysis below includes certain forward-looking statements related to
future operating losses and our potential for profitability, the sufficiency of our cash resources,
our ability to obtain additional equity or debt financing, possible partnering or other strategic
opportunities for the development of our products, as well as other statements related to the
progress and timing of product development, present or future licensing, collaborative or financing
arrangements or that otherwise relate to future periods, which are all forward-looking statements
as defined by the Private Securities Litigation Reform Act of 1995. These statements represent,
among other things, the expectations, beliefs, plans and objectives of management and/or
assumptions underlying or judgments concerning the future financial performance and other matters
discussed in this document. The words may, will, should, plan, believe, estimate,
intend, anticipate, project, and expect and similar expressions are intended to identify
forward-looking statements. All forward-looking statements involve certain risks, uncertainties and
other factors described elsewhere in this quarterly report, 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. We intend to focus on certain metabolic and inflammatory diseases. By utilizing our
expertise in RNAi and the RNAi technology platform that we have established, we believe we will be
able to discover and develop lead compounds and move them into and through development for
potential commercialization more efficiently than traditional drug development approaches.
We were formed in 2006 by CytRx 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 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 on January
8, 2007. These assets consisted primarily of RNAi licenses and related intellectual property, and a
nominal amount of equipment. The cost of the licenses had previously been expensed by CytRx as
in-process research and development and was recorded in the predecessor financial statements at
cost.
To date, RXis principal activities have consisted of conducting research and pre-clinical
development activities utilizing its RNAi therapeutic platform, acquiring key RNAi technologies and
patent rights through exclusive and non-exclusive licenses, recruiting a RNAi-focused management
and scientific/clinical advisory team, capital raising activities and conducting business
development activities aimed at establishing development partnerships with pharmaceutical and
larger biotech companies.
We have not generated revenue to date and may not generate revenue in the foreseeable future,
if ever. We expect to incur significant operating losses as we advance our product candidates
through the drug development and regulatory process. In addition to increasing research and
development expenses, we expect general and administrative costs to increase related to operation
as a public company and as we add personnel. We will need to generate significant revenues to
achieve profitability and might never do so. In the absence of product revenues, our potential
sources of operational funding are expected to be the proceeds from the sale of equity, funded
research and development payments and payments under collaborative agreements. We believe that our
existing cash, cash
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equivalents, and potential proceeds from the SEDA should be sufficient to fund our operations
through at least the first half of 2010. In the future, we will be dependent on obtaining
financing from third parties in order to maintain our operations. We cannot assure that additional
debt or equity or other funding will be available to us on acceptable terms, or at all. If we fail
to obtain additional funding when needed, we would be forced to scale back, or terminate, our
operations, or to seek to merge with or to be acquired by another company.
As the Company has not generated any revenues since inception through March 31, 2009, we are
considered a development stage company for accounting purposes.
Results of Operations
For the Three Months ended March 31, 2009 and 2008
For the three months ended March 31, 2009, our net loss was approximately $4,171,000 compared
to a net loss of $2,646,000 for the three months ended March 31, 2008. The loss increased by
$1,525,000, or approximately 57%. Reasons for the variations in the losses between the years 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 or
SAB members, patent prosecution costs, and the cost of supplies and reagents used in our research
and development programs. We expect research and development expenses to increase as we expand our
discovery and development activities for RNAi therapeutics.
Total research and development expenses were approximately $1,416,000 for the three months
ended March 31, 2009, compared to $1,088,000 for the three months ended March 31, 2008. The
increase of $328,000 or 30% was primarily due to a $221,000 increase in costs associated with
employee compensation, due to a 50% 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 including accounting, investor relations,
business and technology development, in house legal and patent personnel and human resources, as
well as legal fees, audit and tax fees, consultants and professional services and general corporate
expenses.
General and administrative expenses were approximately $2,755,000 for the three months ended
March 31, 2009, compared with $1,633,000 for the three months ended March 31, 2008. The increase of
$1,122,000 or 69% was primarily due to non-cash stock warrant compensation cost issued for a
warrant for business advisory services under an investment banking agreement and common stock
issued in exchange for general and administrative services, which were $734,000 and $281,000
respectively in the three months ended March 31, 2009 and were $0 in the three months ended March
31, 2008.
Interest income
Interest income was negligible for the three months ended March 31, 2009, compared with
approximately $75,000 for the three months ended March 31, 2008. This decrease was primarily due to
the current rates available to us on our excess cash and cash equivalents. Our investment policies
main objective requires us to invest in securities that preserve principle and liquidity is
sufficient to meet our operating cash flow needs. Invested assets may therefore not earn as high a
level of income as long-term or lower quality securities, which generally have less liquidity and
more volatility. The rates on these types of investments are very low in todays market.
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Operating Results
We reported a loss from operations of $4,171,000 in the three month period ended March 31,
2009, compared to a loss from operations of $2,721,000 in the corresponding period in 2008, an
increase in loss of $1,450,000, or 53%. This increase was due to increased operating expenses as
noted above.
We reported a net loss of $4,171,000 in the three month period ended March 31, 2009, compared
to a net loss of $2,646,000 in the corresponding period in 2008, an increase in net loss of
$1,525,000 or 58%, and a net loss per share of $0.30 and $0.21, respectively.
Liquidity and Capital Resources
In April 2007, we issued 3,273,292 shares of common stock (valued at approximately $5.00 per
share, based in part, upon the advice of the third-party valuation advisor and assuming the
issuance of 462,112 shares to UMMS pursuant to our license agreements with them) in exchange for
$15.0 million in cash from CytRx and the settlement of our inter-company account payable due to
CytRx of approximately $2.0 million. On June 24, 2008, we issued 1,073,299 shares of our common
stock to institutional investors at $8.12 per share resulting in aggregate gross proceeds of
approximately $8.7 million. On January 30, 2009, we entered into a SEDA with YA Global, pursuant
to which we may, at our option over a two-year period, periodically sell to YA Global shares of our
common stock, for a total purchase price of up to $25,000,000.
We have not had any revenue since inception nor are any revenues expected for the foreseeable
future; however, it will be necessary for us to fund our operations, including general and
administrative expenses as well as expenditures for research and development. We believe that our
existing cash, cash equivalents, and potential proceeds from the SEDA should be sufficient to fund
our operations through at least the first half of 2010. In the future, we will be dependent on
obtaining financing from third parties in order to maintain our operations. We cannot assure that
additional debt or 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
Net cash used in operating activities was approximately $2,672,000 for the three month period
ended March 31, 2009, compared with $1,668,000 net cash used in operating activities for the three
month period ended March 31, 2008. The increase of approximately $1,004,000 in the use of cash
resulted primarily from a net loss of $4,171,000, relating to increase costs associated with a 50%
increase in headcount as well as an increase in patent costs related to patent applications on
internal discoveries, less the add back of non-cash items of $1,431,000, of which $659,000 related
to stock-based compensation, $1,015,000 in stock warrant expense in exchange for services, $38,000
related to depreciation and $213,000 related to changes in current assets and liabilities.
Net Cash Flow from Investing Activities
Net cash used in investing activities was approximately $8,000 for the three month period
ended March 31, 2009, compared to net cash provided by investing activities of $9,762,000 for the
three month period ended March 31, 2008. The decrease of approximately $9,770,000 in cash provided
by investing activities was primarily due to the redemption of short-term investments in 2008. We
continue to invest in capital expenditures as needed. We do not anticipate any significant
expenditure requirements in the foreseeable future.
Net Cash Flow from Financing Activities
Net cash used in financing activities was $4,000 for the three month period ended March 31,
2009, compared with no cash provided by financing activities for the three month period ended March
31, 2008. The $4,000 related to repayments of capital lease obligations, which did not exist in
the same period last year.
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Off-Balance Sheet Arrangements
We have not entered into off-balance sheet financing, other than operating leases.
Critical Accounting Policies and Estimates
In our Annual Report on Form 10-K for the year ended December 31, 2008, we disclosed our
critical accounting policies and estimates upon which our financial statements are derived. There
have been no changes to these policies since December 31, 2008. Readers are encouraged to review
these disclosures in conjunction with the review of this quarterly report on Form 10-Q.
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ITEM 4. CONTROLS AND PROCEDURES
Disclosure Controls and Procedures
As of the end of the period covered by this quarterly report on Form 10-Q, our Chief Executive
Officer and Chief Financial 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 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, our 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 Securities Exchange Act of 1934 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, 2009 that has materially affected, or is reasonably
likely to materially affect, our internal control over financial reporting.
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RXi PHARMACEUTICALS CORPORATION
PART II OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
None
ITEM 1.A RISK FACTORS
Future sales of our shares by CytRx, or the possibility of such sales, could adversely affect our
stock price.
CytRx owns 6,268,881 shares of our common stock, or approximately 46% of our outstanding
shares. We have agreed that, upon request by CytRx, we will use our best efforts to cause all of
our shares issued to CytRx pursuant to the two contribution agreements we entered into in relation
to our initial capitalization to be registered under the Securities Act, with certain exceptions,
with all expenses incurred in connection with any such registration will be borne by us.
We also have granted CytRx what are commonly known as piggyback registration rights to
include our shares currently owned by CytRx, or owned by CytRx in the future as a result of a
dividend or distribution with respect to shares currently owned by CytRx, in other registration
statements that we may file with the SEC on behalf of our company or our security holders. CytRx
exercised this piggyback registration right in relation to our recent registration statement on
Form S-3, in which 500,000 shares owned by CytRx were registered for resale on an on-going basis.
The availability of our shares held by CytRx for resale publicly, as well as any actual sales of
these shares, could adversely affect the market price of our shares.
If the value of our shares owned by CytRx from time to time were to exceed 40% of the value of
CytRxs total assets, CytRx may be deemed an investment company within the meaning of the
Investment Company Act of 1940 and become subject to the stringent regulations applicable to
investment companies. In this event, CytRx would likely seek to promptly sell or otherwise dispose
of shares of our common stock in order to avoid becoming an inadvertent investment company. Any
such sales or other disposition by CytRx of our shares, or the possibility of such sales or
disposition, could adversely affect the market price of our shares.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
On January 29, 2009, we entered into an Investment Banking Agreement with Legend Securities,
Inc. or Legend, pursuant to which Legend agreed to provide business advisory services to us for a
period of up to six months in exchange for (i) a monthly advisory fee equal to $19,000 per month,
and (ii) the issuance by us of a warrant to purchase 142,500 shares of our common stock at an
exercise price per share equal to the average closing bid price of our common stock for the ten
trading days ending three days prior to January 29, 2009, or $4.273 per share. The Warrant vested
as to 71,250 shares upon issuance, and then will vest at a rate of 23,750 shares per month starting
on the 90 day anniversary of issuance and is exercisable for a period of five years. We also agreed
to give Legend unlimited piggy back registration rights with respect to the shares of our common
stock underlying the Warrant in any registration statement we file in connection with an
underwritten offering of our common stock.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
None
ITEM 5. OTHER INFORMATION
None
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ITEM 6. EXHIBITS
EXHIBIT INDEX
Exhibit | ||
Number | Description | |
10.1
|
Lease Amendment dated March 5, 2009 | |
31.1
|
Sarbanes-Oxley Act Section 302 Certification of Tod Woolf | |
31.2
|
Sarbanes-Oxley Act Section 302 Certification of Stephen J. DiPalma | |
32.1
|
Sarbanes-Oxley Act Section 906 Certification of Tod Woolf and Stephen J. DiPalma |
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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/ Tod Woolf | |||
Tod Woolf, Ph.D. | ||||
President and Chief Executive Officer (Principal Executive Officer) |
||||
By: | /s/ Stephen J. DiPalma | |||
Stephen J. DiPalma | ||||
Chief Financial Officer (Principal Financial and Accounting Officer) |
||||
Date: May 15, 2009 |
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