SELLAS Life Sciences Group, Inc. - Quarter Report: 2009 June (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 June 30, 2009
OR
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File number 001-33958
RXi Pharmaceuticals Corporation
(Exact name of registrant as specified in its charter)
Delaware | 20-8099512 | |
(State of incorporation) | (I.R.S. Employer Identification No.) |
60 Prescott Street, Worcester, MA 01605
(Address of principal executive office) (Zip code)
(Address of principal executive office) (Zip code)
Registrants telephone number: (508) 767-3861
Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the Registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days.
Yes þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on it
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months
(or for such shorter time that the registrant was required to submit and post such files).
Yes o No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer or a smaller reporting company. See the definitions of large accelerated
filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
(Check one):
Large accelerated filer o | Accelerated filer o | Non-accelerated filer o (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
August 12, 2009, RXi Pharmaceuticals Corporation had 16,207,625 shares of common stock,
$0.0001 par value, outstanding.
RXi PHARMACEUTICALS CORPORATION
FORM 10-Q QUARTER ENDED JUNE 30, 2009
FORM 10-Q QUARTER ENDED JUNE 30, 2009
INDEX
2
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 share and per share data)
(Unaudited)
(Amounts in thousands, except share and per share data)
(Unaudited)
June 30, | December 31, | |||||||
2009 | 2008 | |||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 4,362 | $ | 9,856 | ||||
Prepaid expenses and other current assets |
333 | 73 | ||||||
Total current assets |
4,695 | 9,929 | ||||||
Equipment and furnishings, net |
391 | 414 | ||||||
Deposits |
16 | 16 | ||||||
Total assets |
$ | 5,102 | $ | 10,359 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 580 | $ | 394 | ||||
Accrued expenses and other current liabilities |
1,274 | 976 | ||||||
Current maturities of capital lease obligations |
14 | 17 | ||||||
Total current liabilities |
1,868 | 1,387 | ||||||
Capital lease obligations, net of current maturities |
11 | 4 | ||||||
Total liabilities |
1,879 | 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; 13,821,910 and 13,763,231
shares issued and outstanding at June 30, 2009
and December 31, 2008, respectively |
1 | 1 | ||||||
Additional paid-in capital |
37,837 | 34,330 | ||||||
Deficit accumulated during the developmental stage |
(34,615 | ) | (25,363 | ) | ||||
Total stockholders equity |
3,223 | 8,968 | ||||||
Total liabilities and stockholders equity |
$ | 5,102 | $ | 10,359 | ||||
The accompanying notes are an integral part of these financial statements.
3
Table of Contents
RXi PHARMACEUTICALS CORPORATION
(A Development Stage Company)
(A Development Stage Company)
CONDENSED STATEMENTS OF EXPENSES
(Amounts in thousands, except share and per share data)
(Unaudited)
(Amounts in thousands, except share and per share data)
(Unaudited)
Period from | ||||||||||||||||||||
January 1, 2003 | ||||||||||||||||||||
For the Three | For the Three | For the Six | For the Six | (Date of | ||||||||||||||||
Months Ended | Months Ended | Months Ended | Months Ended | Inception) to | ||||||||||||||||
June 30, | June 30, | June 30, | June 30, | June 30, | ||||||||||||||||
2009 | 2008 | 2009 | 2008 | 2009 | ||||||||||||||||
Expenses: |
||||||||||||||||||||
Research and development expense |
$ | 1,817 | $ | 1,307 | $ | 3,011 | $ | 2,189 | $ | 16,920 | ||||||||||
Research and development
employee stock-based
compensation expense |
212 | 73 | 412 | 113 | 868 | |||||||||||||||
Research and development
non-employee stock-based
compensation expense |
997 | 1,386 | 1,019 | 1,552 | 5,042 | |||||||||||||||
Fair value of common stock in
exchange for licensing rights |
| | | | 3,954 | |||||||||||||||
Total research and development
expenses |
3,026 | 2,766 | 4,442 | 3,854 | 26,784 | |||||||||||||||
General and administrative |
1,425 | 1,154 | 2,728 | 2,364 | 12,862 | |||||||||||||||
General and administrative
employee stock-based
compensation |
532 | 426 | 969 | 849 | 3,775 | |||||||||||||||
Common stock warrants issued
for general and administrative
expenses |
92 | | 826 | | 1,576 | |||||||||||||||
Fair value of common stock
issued in exchange for general
and administrative expenses |
| | 281 | | 281 | |||||||||||||||
Total general and
administrative expenses |
2,049 | 1,580 | 4,804 | 3,213 | 18,494 | |||||||||||||||
Operating loss |
(5,075 | ) | (4,346 | ) | (9,246 | ) | (7,067 | ) | (45,278 | ) | ||||||||||
Interest income (expense) |
(2 | ) | 28 | (2 | ) | 103 | 626 | |||||||||||||
Other income (expense) |
(4 | ) | | (4 | ) | | (4 | ) | ||||||||||||
Net loss |
$ | (5,081 | ) | $ | (4,318 | ) | $ | (9,252 | ) | $ | (6,964 | ) | $ | (44,656 | ) | |||||
Net loss per common share: |
||||||||||||||||||||
Basic and diluted loss per share |
$ | (0.37 | ) | $ | (0.34 | ) | $ | (0.67 | ) | $ | (0.55 | ) | N/A | |||||||
Weighted average common shares
outstanding: |
||||||||||||||||||||
Basic and diluted |
13,821,817 | 12,743,404 | 13,812,367 | 12,713,918 | 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 share and per share data)
(Unaudited)
(Amounts in thousands, except share and per share data)
(Unaudited)
Period from | ||||||||||||
January 1, 2003 | ||||||||||||
(Date of | ||||||||||||
For the Six | For the Six | Inception) | ||||||||||
Months Ended | Months Ended | through | ||||||||||
June 30, | June 30, | June 30, | ||||||||||
2009 | 2008 | 2009 | ||||||||||
Cash flows from operating activities: |
||||||||||||
Net loss |
$ | (9,252 | ) | $ | (6,964 | ) | $ | (44,656 | ) | |||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||||||
Depreciation and amortization expense |
80 | 62 | 247 | |||||||||
Loss on disposal of equipment |
4 | 8 | 12 | |||||||||
Non-cash rent expense |
| 29 | 29 | |||||||||
Accretion and receipt of bond discount |
| 171 | 35 | |||||||||
Non-cash share-based compensation |
2,400 | 2,514 | 9,687 | |||||||||
Fair value of common stock warrants issued in exchange for services |
826 | | 1,576 | |||||||||
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 |
(260 | ) | (336 | ) | (333 | ) | ||||||
Accounts payable |
186 | 416 | 580 | |||||||||
Due to former parent |
| (207 | ) | (207 | ) | |||||||
Accrued expenses and other current liabilities |
298 | (28 | ) | 1,274 | ||||||||
Net cash used in operating activities |
(5,437 | ) | (4,335 | ) | (27,521 | ) | ||||||
Cash flows from investing activities: |
||||||||||||
Purchase of short-term investments |
| (6,054 | ) | (31,542 | ) | |||||||
Maturities of short-term investments |
| 9,780 | 31,507 | |||||||||
Cash paid for purchase of equipment and furnishings |
(46 | ) | (76 | ) | (544 | ) | ||||||
Disposal of equipment and furnishings |
(1 | ) | | (1 | ) | |||||||
Cash paid for lease deposit |
| 21 | (45 | ) | ||||||||
Net cash provided by (used in) investing activities |
(47 | ) | 3,671 | (625 | ) | |||||||
Cash flows from financing activities: |
||||||||||||
Net proceeds from issuance of common stock |
| 7,934 | 23,418 | |||||||||
Net proceeds from exercise of common stock options |
| | 356 | |||||||||
Repayments of capital lease obligations |
(10 | ) | (13 | ) | (32 | ) | ||||||
Cash advances from former parent company, net |
| | 8,766 | |||||||||
Net cash provided by (used in) financing activities |
(10 | ) | 7,921 | 32,508 | ||||||||
Net increase (decrease) in cash and cash equivalents |
(5,494 | ) | 7,257 | 4,362 | ||||||||
Cash and cash equivalents at the beginning of period |
9,856 | 1,763 | | |||||||||
Cash and cash equivalents at end of period |
$ | 4,362 | $ | 9,020 | $ | 4,362 | ||||||
Supplemental disclosure of cash flow information: |
||||||||||||
Cash received during the period for interest |
$ | | $ | 243 | $ | 723 | ||||||
Cash paid during the period for interest |
$ | 2 | $ | | $ | 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 |
$ | | $ | | $ | | ||||||
Equipment and furnishings acquired through capital lease |
$ | 14 | $ | 43 | $ | 43 | ||||||
Non-cash lease deposit |
$ | | $ | | $ | 50 | ||||||
The accompanying notes are an integral part of these financial statements.
5
Table of Contents
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 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.
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
June 30, 2009, the Company is considered a development-stage company for accounting purposes.
The Company expects to incur significant operating losses for the foreseeable future while it
advances its future product candidates from discovery through pre-clinical studies and clinical
trials and seeks regulatory approval and potential commercialization, even if the Company is
collaborating with pharmaceutical and larger biotech companies. The Company also expects general
and administrative costs to increase as it recruits additional management and administrative
personnel. The Company will need to generate significant revenues to achieve profitability and may
never do so.
In the future, the Company will be dependent on obtaining funding from third parties 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 accompanying condensed financial statements have been prepared in accordance with the
rules and regulations of the 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 and six month periods ended June 30,
2009 and 2008, as well as the cumulative financial information for the period from January 1, 2003
(date of inception) through June 30, 2009, is unaudited and has been prepared on the same basis as
the audited financial statements and includes all adjustments, consisting of only normal recurring
adjustments, necessary for the fair presentation of this information in all material respects. The
results of any interim period are not necessarily indicative of the results of operations to be
expected for a full fiscal year. There have been no material changes to the Companys significant
accounting policies as disclosed in the Companys Annual Report on Form 10-K for the year ended
December 31, 2008.
Uses of estimates in preparation of financial statements
The preparation of financial statements in accordance with accounting principles generally
accepted in the United States of America requires management to make estimates and assumptions that
affect the reported amounts of assets and liabilities and disclosure of contingent assets and
liabilities at the date of the financial statements and the reported amounts of revenues and
expenses during the reporting period. Actual results could differ from these estimates.
Reclassifications
Certain prior year amounts have been reclassified to conform with the current years
presentation.
6
Table of Contents
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 six month period ended June 30,
2009 and 2008, the following assumptions were used:
2009 | 2008 | |||||||
Risk-free interest rate |
1.55% - 3.84 | % | 3.29% - 3.99 | % | ||||
Expected volatility |
116.72% - 122.93 | % | 101.80 | % | ||||
Expected lives (years) |
6 10 | 6 10 | ||||||
Expected dividend yield |
0.00 | % | 0.00 | % |
The weighted average fair value of options granted during the six month period ended June 30,
2009 and 2008 was $4.42 and $6.96 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 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.
7
Table of Contents
The following table summarizes stock option activity from January 1, 2009 through June 30,
2009:
Total Number | Weighted Average | |||||||
of Shares | Exercise Price | |||||||
Outstanding at January 1, 2009 |
2,223,452 | $ | 6.11 | |||||
Granted |
1,167,546 | 4.42 | ||||||
Cancelled |
8,375 | 5.34 | ||||||
Outstanding at June 30, 2009 |
3,382,342 | $ | 5.53 | |||||
Options exercisable at June 30, 2009 |
1,787,285 | $ | 5.49 | |||||
The aggregate intrinsic values of outstanding and exercisable options at June 30, 2009 were
calculated based on the closing price of the Companys stock on June 30, 2009 of $4.54 per share
less the exercise price of those shares. The total intrinsic value of outstanding stock options and
exercisable common stock options for the six months ended June 30, 2009 and 2008 was $266,000 and
$55,000 and $4,685,000 and $2,375,000, respectively.
3. 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:
June 30, | ||||||||
2009 | 2008 | |||||||
Options to purchase common stock |
3,382,342 | 1,987,293 | ||||||
Warrants to purchase common stock |
332,500 | | ||||||
Total |
3,714,842 | 1,987,293 | ||||||
4. License Agreements
As part of its business, the Company enters into significant licensing agreements. During the
quarter, the Companys terminated several license agreements previously disclosed in the Companys
Annual Report on Form 10-K for the year ended December 31, 2008.
5. 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 FAS Staff Position (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, 2010. 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.
8
Table of Contents
6. Recent Accounting Pronouncements
In June 2009, the Financial Accounting Standards Board (FASB) issued SFAS No. 168, The FASB
Accounting Standards Codification and the Hierarchy of Generally Accepted Accounting Principles".
This standard replaces SFAS No. 162, The Hierarchy of Generally Accepted Accounting Principles, and
establishes only two levels of U.S. GAAP, authoritative and non-authoritative. The FASB Accounting
Standards Codification (the Codification) will become the source of authoritative,
non-governmental GAAP, except for rules and interpretive releases of the SEC, which are sources of
authoritative GAAP for SEC registrants. All other non-grandfathered, non-SEC accounting literature
not included in the Codification will become non-authoritative. This statement is effective for
financial statements for interim or annual reporting periods ending after September 15, 2009. The
Company will begin to use the new guidelines and numbering system prescribed by the Codification
when referring to U.S. GAAP in the third quarter of fiscal 2009. As the Codification was not
intended to change or alter existing U.S. GAAP, it will not have any impact on the Companys
financial position, results of operations or cash flows.
In June 2009, the FASB issued SFAS No. 167, Amendments to FASB Interpretation No. 46(R).
This statement amends the consolidation guidance applicable to variable interest entities and is
effective as of January 1, 2010. The Company is currently in the process of evaluating the impact
of this pronouncement.
In June 2009, the FASB issued SFAS No. 166, Accounting for Transfers of Financial Assets, an
amendment to SFAS No. 140. This statement eliminates the concept of a qualifying special-purpose
entity, changes the requirements for derecognizing financial assets, and requires additional
disclosures in order to enhance information reported to users of financial statements by providing
greater transparency about transfers of financial assets, including securitization transactions,
and an entitys continuing involvement in and exposure to the risks related to transferred
financial assets. This statement is effective for fiscal years beginning after November 15, 2009.
The Company is currently in the process of evaluating the impact of this pronouncement.
In May 2009, the FASB issued SFAS No. 165, Subsequent Events. This statement sets forth (i)
the period after the balance sheet date during which management of a reporting entity should
evaluate events or transactions that may occur for potential recognition or disclosure in the
financial statements, (ii) the circumstances under which an entity should recognize events or
transactions occurring after the balance sheet date in its financial statements, and (iii) the
disclosures that an entity should make about events or transactions that occurred after the balance
sheet date. SFAS No. 165 is effective for interim and annual periods ending after June 15, 2009.
The Company adopted SFAS No. 165 in the quarter ending June 30, 2009. The adoption of SFAS No. 165
did not have any impact on the Companys financial position, results of operations or cash flows.
The Company evaluated all events or transactions that occurred after June 30, 2009 through August
14, 2009, the date the Company issued these financial statements. During this period the Company
did not have any material recognizable subsequent events other than what is disclosed in footnote
7.
In April 2009, the 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. The Company is currently evaluating
these staff positions and the impact, if any, that adoption will have on its financial position and
results of operation.
9
Table of Contents
In June 2007, the Emerging Issues Task Force issued EITF Issue 07-03, Accounting for Advance
Payments for Goods or Services to Be Used in Future Research and Development, or EITF 07-03. EITF
07-03 addresses the diversity which exists with respect to the accounting for the non-refundable
portion of a payment made by a research and development entity for future research and development
activities. Under EITF 07-03, an entity would defer and capitalize non-refundable advance payments
made for research and development activities until the related goods are delivered or the related
services are performed. EITF 07-03 was effective for fiscal years beginning after December 15, 2007
and interim periods within those years. The adoption of EITF 07-03 did not have a material impact
on the Companys financial statements.
7. The Offering and Subsequent Events
The Company filed a Registration Statement on Form S-3 (File No. 333-158968, the Registration
Statement) on May 4, 2009, which the SEC declared effective on May 22, 2009. Pursuant to the
Registration Statement, the Company may issue, in one or more offerings, shares of common stock,
preferred stock, warrants or debt securities at an aggregate initial offering price not to exceed
$30,000,000.
On March 17, 2009, the Company entered into a placement agency agreement, which was
subsequently amended on May 26, 2009 and July 22, 2009, with Rodman & Renshaw, LLC as the exclusive
placement agent, relating to a proposed offering by the Company of new securities to potential
investors. On July 30, 2009, the Company entered in definitive agreements for the sale and issuance
by the Company to certain investors of 2,385,715 units, with each unit consisting of (i) one share
of the Companys common stock, par value $0.0001 per share and (ii) a warrant to purchase 0.40 of a
share of common stock, at a purchase price of $3.50 per unit, pursuant to the Registration
Statement (the Offering). The Offering closed on August 4, 2009. The warrants will generally be
exercisable for a period beginning six months and ending five years from the closing date, and will
carry a price per share equal to $4.50, or 105% of the closing price of the common stock on July
30, 2009. The Company raised gross proceeds of approximately $8,350,000 in the Offering and net
proceeds, after deducting the placement agents fees and other offering expenses payable by the
Company, were approximately $7,766,500.
As part of the placement agency agreement, the Company issued a warrant to purchase 23,857
shares to the placement agency as part of their fees for the offering of new securities to
investors. The warrants have an exercise price of $4.38 per share and expire five years from the
date of issuance on August 3, 2014. The warrants are immediately vested and are exercisable for a
period of five years.
10
Table of Contents
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 June 30, 2009 and
results of operations for the three and six months ended June 30, 2009 and 2008 should be read in
conjunction with managements discussion and analysis of financial condition and results of
operations included in our Annual Report on Form 10-K for the year ended December 31, 2008.
The discussion and analysis below includes certain forward-looking statements related to
future operating losses and our potential for profitability, the sufficiency of our cash resources,
our ability to obtain additional equity or debt financing, possible partnering or other strategic
opportunities for the development of our products, as well as other statements related to the
progress and timing of product development, present or future licensing, collaborative or financing
arrangements or that otherwise relate to future periods, which are all forward-looking statements
as defined by the Private Securities Litigation Reform Act of 1995. These statements represent,
among other things, the expectations, beliefs, plans and objectives of management and/or
assumptions underlying or judgments concerning the future financial performance and other matters
discussed in this document. The words may, will, should, plan, believe, estimate,
intend, anticipate, project, and expect and similar expressions are intended to identify
forward-looking statements. All forward-looking statements involve certain risks, uncertainties and
other factors described elsewhere in 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. 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. 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 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 equivalents and proceeds from the
Registered Direct Offering that we closed on August 4, 2009 should be sufficient to fund our
operations for at least 12 months. In the future, we will be dependent on obtaining financing from
third parties in order to maintain our
11
Table of Contents
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 June 30, 2009, we are
considered a development stage company for accounting purposes.
Results of Operations
For the Three Months ended June 30, 2009 and 2008
For the three months ended June 30, 2009, our net loss was approximately $5,081,000 compared
to a net loss of $4,318,000 for the three months ended June 30, 2008. The loss increased by
$763,000, or approximately 18%. 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, 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 $3,026,000 for the three months
ended June 30, 2009, compared to $2,766,000 for the three months ended June 30, 2008. The increase
of $260,000 or 9% was primarily due to a $139,000 increase in costs associated with employee
compensation, due to a 40% increase in headcount as well as an increase in patent costs related to
patent applications on internal discoveries offset by a $250,000 decrease in stock-based
compensation expense.
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 $2,049,000 for the three months ended
June 30, 2009, compared with $1,580,000 for the three months ended June 30, 2008. The increase of
$469,000 or 30% was primarily due to a $271,000 increase due to the addition of new staff in 2009,
$106,000 increase in non-cash share based compensation and a $92,000 increase due to non-cash
compensation expense related to a warrant issued for business advisory services in the three months
ended June 30, 2009. There was no non-cash warrant compensation expense for the three months ended
June 30, 2008.
Interest income
Interest income was negligible for the three months ended June 30, 2009, compared with
approximately $28,000 for the three months ended June 30, 2008. This decrease was primarily due to
the current interest rates available to us on our cash and cash equivalents during the three months ended June 30, 2009. The key objectives of our
investment policy are to preserve principal and ensure sufficient liquidity, so our invested cash
may not earn as high a level of income as longer-term or lower quality securities, which generally
have less liquidity and more volatility. The interest rates available on higher quality,
shorter-term investments in todays market are lower than rates available in the prior period.
12
Table of Contents
Operating Results
We reported a loss from operations of $5,075,000 in the three month period ended June 30,
2009, compared to a loss from operations of $4,346,000 in the corresponding period in 2008, an
increased loss of $729,000, or 17%. This increase was due to increased operating expenses as noted
above.
We reported a net loss of $5,081,000 in the three month period ended June 30, 2009, compared
to a net loss of $4,318,000 in the corresponding period in 2008, an increase in net loss of
$763,000 or 18%, and a net loss per share of $0.37 and $0.34, respectively.
For the Six Months ended June 30, 2009 and 2008
Research and Development Expense
Research and development expenses were $4,442,000 for the six months ended June 30, 2009,
compared to $3,854,000 for the six months ended June 30, 2008. The increase of $588,000 or 15%, was
due to higher staff cost of $1,063,000 and supplies costs of $594,000, partially offset by combined
employee and non-employee stock based compensation of $1,431,000 in the six months ended June 30,
2009, compared to combined employee and non-employee stock based compensation of $1,665,000 in the
six months ended June 30, 2008. Research and development expense consists primarily of
compensation-related costs for our employees dedicated to research and development activities and
for our SAB members, annual license maintenance fees, and the cost of supplies and reagents used in
our research and development programs. We expect research and development expenses to increase as
we expand our discovery and development activities for RNAi therapeutics.
General and Administrative Expense
General and administrative expenses were $4,804,000 for the six months ended June 30, 2009,
compared to $3,213,000 for the six months ended June 30, 2008. The increase of $1,591,000, or 50%,
was due to higher staff-related costs, including $969,000 in stock-based compensation expense, and
to $826,000 in warrant expense related to a warrant issued for business advisory services and
$281,000 in common stock issued under the SEDA. General and administrative expenses include
compensation-related costs for our employees dedicated to general and administrative activities,
legal fees, audit and tax fees, consultants and professional services and general corporation
expenses.
Interest income
Interest income was approximately $2,000 for the six months ended June 30, 2009, compared to
approximately $103,000 for the six months ended June 30, 2008. This decrease was primarily due to
larger average balances of our cash, cash equivalents or short-term investments during the six
months ended June 30, 2008 as well as lower interest rates during the six months ended June 30,
2009.
Operating Results
We reported a loss from operations of $9,246,000 in the six month period ended June 30, 2009
compared to a loss from operations of $7,067,000 in the corresponding period in 2008, an increase
in loss of $2,179,000, or 31%. This increase was due primarily to increased expenses related to
non-cash equity compensation, as noted above.
We reported a net loss of $9,252,000 in the six month period ended June 30, 2009, compared to
a net loss of $6,964,000 in the corresponding period in 2008, an increase in net loss of $2,288,000
or 33%, and a net loss per share of $0.67 and $0.55, 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
13
Table of Contents
1,073,299 shares of our common stock to institutional investors at $8.12 per share resulting
in aggregate gross proceeds of approximately $8.7 million. On January 30, 2009, we entered into
the SEDA with YA Global, pursuant to which we may, at our option over a two-year period,
periodically sell to YA Global shares of our common stock, for a total purchase price of up to
$25,000,000. On August 4, 2009, we closed a registered direct offering (the Offering) in which
we sold 2,385,715 units at $3.50 per unit, each unit consisting of a share of our common stock and
a warrant to purchase .40 of a share of our common stock. Warrants to purchase up to a total of
954,286 shares of our common stock at an exercise price of $4.50 per share. We received net
proceeds of $7.8 million.
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 proceeds from the Offering we closed on August 4, 2009 should
be sufficient to fund our operations for at least 12 months. 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 $5,437,000 for the six month period
ended June 30, 2009, compared with $4,335,000 net cash used in operating activities for the six
month period ended June 30, 2008. The increase of approximately $1,102,000 resulted primarily from
a net loss of $9,252,000, less the add back of non-cash items of $3,591,000, of which $2,400,000
related to stock-based compensation, $826,000 related to stock warrant expense in exchange for
services, $80,000 related to depreciation and $224,000 related to changes in current assets and
liabilities.
Net Cash Flow from Investing Activities
Net cash used in investing activities was approximately $47,000 for the six month period ended
June 30, 2009, compared to net cash provided by investing activities of $3,671, 000 for the six
month period ended June 30, 2008. The decrease of approximately $3,718,000 in cash provided by
investing activities was primarily due to net redemption of short-term investments in 2008.
Net Cash Flow from Financing Activities
Net cash used in financing activities was $10,000 for the six month period ended June 30,
2009, compared with $7,921,000 cash provided by financing activities for the six month period ended
June 30, 2008. This decrease was primarily due to the issuance of common stock in the amount of
$7,934,000 to institutional investors in the second quarter of 2008.
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.
14
Table of Contents
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 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 June 30, 2009 that has materially affected, or is reasonably
likely to materially affect, our internal control over financial reporting.
15
Table of Contents
RXi PHARMACEUTICALS CORPORATION
PART II OTHER INFORMATION
PART II OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
None
ITEM 1.A RISK FACTORS
You should consider the Risk Factors included under Item 1A. of our annual report on Form 10-K
for the year ended December 31, 2008, filed on March 18, 2009 with the SEC.
We will be subject to competition and may not be able to compete successfully.
A number of medical institutions and pharmaceutical companies are seeking to develop
therapeutic products. Companies working in this area include: Alnylam Pharmaceuticals, MDRNA Inc.,
Tekmira Pharmaceuticals, Dicerna Pharmaceuticals, Cequent Pharmaceuticals, Tacere Therapeutics,
Benitec Ltd., OPKO Health, Silence Therapeutics, Quark Pharmaceuticals, Rosetta Genomics, Lorus
Therapeutics and Calando Pharmaceuticals, as well as a number of the multinational pharmaceutical
companies. In addition, a number of companies are developing therapeutics for the same diseases we
are targeting using technologies other than RNA interference. Most of these competitors have
substantially greater research and development capabilities and financial, scientific, technical,
manufacturing, marketing, distribution, and other resources than us, and we may not be able to
successfully compete with them. In addition, even if we are successful in developing our product
candidates, in order to compete successfully we may need to be first to market or to demonstrate
that our RNAi based products are superior to therapies based on different technologies. If we are
not first to market or are unable to demonstrate such superiority, any products for which we are
able to obtain approval may not be successful.
We will rely upon third parties for the manufacture of our clinical product candidates.
We do not have the facilities or expertise to manufacture supplies of any of our potential
product candidates. Accordingly, we will be dependent upon contract manufacturers for these
supplies. We have no manufacturing supply arrangements for any of our product candidates, and there
can be no assurance that we will be able to secure needed supply arrangements on attractive terms,
or at all. Our failure to secure these arrangements as needed could have a materially adverse
effect on our ability to complete the development of our product candidates or, if we obtain
regulatory approval for our product candidates, to commercialize them.
Our current plans call for the manufacture of our rxRNA compounds and, as necessary, any
delivery vehicles that may be used to deliver our rxRNA compounds in vivo, such as the particles
used to deliver our rxRNA compounds to macrophages by contract manufacturers offering research
grade, Good Laboratory Practices grade and Good Manufacturing Practices grade materials for
preclinical studies (e.g. toxicology studies) and for clinical use. The chemistry, manufacturing
and controls for RNAi active pharmaceutical ingredient will be addressed by our clinical
development team in close collaboration with a contract manufacturer with extensive experience in
RNA drug synthesis. RNA is a complex molecule requiring many synthesis steps, which may lead to
challenges with purification and scale-up. These challenges could result in increased costs and
delays in manufacturing. Additionally, although we are not currently aware of any such litigation
or threatened litigation or challenge, if we have litigation or threatened litigation for or
challenge to the composition of our products candidates in the future, manufacturers may refuse to
manufacture such compounds.
We may be unable to protect our intellectual property rights licensed from UMMS or others, our
intellectual property rights may be inadequate to prevent third parties from using our technologies
or developing competing products, and we may need to license additional intellectual property from
others.
We have a non-exclusive license to the Mello and Fire foundational RNAi patent owned by UMMS
and the Carnegie Institution of Washington, which claims various aspects of RNAi or genetic
inhibition by double stranded RNA. This license continues to be available to third parties, and as
such it does not provide us with the ability to exclude others from its use or protect us from
competition. Therapeutic applications of gene silencing technologies, delivery methods, and other
technologies that we license from UMMS are also claimed in a number of UMMS
16
Table of Contents
pending patent applications, but there can be no assurance that these applications will result
in any issued patents or that those patents would withstand possible legal challenges or protect
our technologies from competition. United States Patent and Trademark Office and patent granting
authorities in other countries have upheld stringent standards for the RNAi patents that have been
prosecuted so far. Consequently, pending patents that we have licensed may continue to experience
long and difficult prosecution challenges and may ultimately issue with much narrower claims than
those in the pending applications. We are aware of a number of issued patents covering various
particular forms and compositions of RNAi-mediating molecules and therapeutic methods that we do
not currently expect to use. Third parties may, however, hold or seek to obtain additional patents
that could make it more difficult or impossible for us to develop products based on the gene
silencing technology that we have licensed.
In addition, others may challenge the patent owned by UMMS and the Carnegie Institution of
Washington or other patents that we currently license or may license in the future and, as a
result, these patents could be narrowed, invalidated or rendered unenforceable, which would
negatively affect our ability to exclude others from use of RNAi technologies described in these
patents. There can be no assurance that these patent or other pending applications or issued
patents we licensed in will withstand possible legal challenges. Moreover, the laws of some foreign
countries may not protect our proprietary rights to the same extent as do the laws of the United
States. Any patents issued to us or our licensors may not provide us with any competitive
advantages, and there can be no assurance that the patents of others will not have an adverse
effect on our ability to do business or to continue to use our technologies freely. Our efforts to
enforce and maintain our intellectual property rights may not be successful and may result in
substantial costs and diversion of management time. Even if our rights are valid, enforceable and
broad in scope, competitors may develop products based on technology that is not covered by our
licenses.
We may need to license additional intellectual property rights from third parties in order to
be able to complete the development or enhance the efficacy of our product candidates or avoid
possible infringement of the rights of others. Additionally, many of our UMMS licenses are limited
to ALS, obesity, diabetes and cancer, and in order to pursue other diseases against proprietary
gene targets, we may need licenses from third parties that may be unavailable. To the extent that
we are required to obtain multiple licenses from third parties to develop or commercialize a
product candidate, the aggregate licensing fees and milestones and royalty payments made to these
parties may materially reduce our economic returns or even cause us to abandon development or
commercialization of a product candidate. Accordingly, there is no assurance that we will be able
to acquire any additional intellectual property rights on satisfactory terms, or at all.
In addition to our licenses, we also rely on copyright and trademark protection, trade
secrets, know-how, continuing technological innovation and licensing opportunities. In an effort to
maintain the confidentiality and ownership of our trade secrets and proprietary information, we
require our employees, consultants, advisors and others to whom we disclose confidential
information to execute confidentiality and proprietary information agreements. However, it is
possible that these agreements may be breached, invalidated or rendered unenforceable, and if so,
there may not be an adequate corrective remedy available. Furthermore, like many companies in our
industry, we may from time to time hire scientific personnel formerly employed by other companies
involved in one or more areas similar to the activities we conduct. In some situations, our
confidentiality and proprietary information agreements may conflict with, or be subject to, the
rights of third parties with whom our employees, consultants or advisors have prior employment or
consulting relationships. Although we require our employees and consultants to maintain the
confidentiality of all confidential information of previous employers, we or these individuals may
be subject to allegations of trade secret misappropriation or other similar claims as a result of
their prior affiliations. Finally, others may independently develop substantially equivalent
proprietary information and techniques, or otherwise gain access to our trade secrets. Our failure
to protect our proprietary information and techniques may inhibit or limit our ability to exclude
certain competitors from the market and execute our business strategies.
Our success depends upon our ability to obtain and maintain intellectual property protection for
our products and technologies.
Our success will depend on our ability to obtain and maintain adequate protection of our
intellectual property covering our product candidates and technologies. The ultimate degree of
patent protection that will be afforded to biotechnology products and processes, including ours, in
the United States and in other important markets remains uncertain and is dependent upon the scope
of protection decided upon by the patent offices, courts and lawmakers in these countries. There is
no certainty that our existing patents, or patent applications if obtained, will afford us
substantial protection or commercial benefit. Similarly, there is no assurance that our pending
patent applications or
17
Table of Contents
patent applications licensed from third parties will ultimately be granted as patents or that
those patents that have been issued or are issued in the future will stand if they are challenged
in court.
We may not be able to obtain sufficient financing, and may not be able to develop our product
candidates.
We believe that our existing cash, cash equivalents, and potential proceeds from this offering
and the Standby Equity Distribution Agreement, or SEDA, we entered into on January 30, 2009 with YA
Global Master SPV Ltd., or YA Global, should be sufficient to fund our operations through 2010. In
the future, we will be dependent on obtaining further financing from third parties in order to
maintain our operations and to meet our financial obligations. Before we are able to access
additional capital from the SEDA, we must satisfy certain conditions, including the requirement
that shares of our stock to be sold to YA Global be registered with the U.S. Securities and
Exchange Commission (SEC), and there is risk of delays in our satisfying these conditions. In
addition, pursuant to the terms of the securities purchase agreements related to this offering, we
are prohibited from issuing shares under the SEDA for a period of 30 days. We cannot assure that
additional debt or equity or other funding to maintain our operations and to meet our obligations
to our licensors will be available to us in the future 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.
We anticipate that we will need to raise substantial amounts of money to fund a variety of
future activities integral to the development of our business, which may include but are not
limited to the following:
| to conduct research and development to successfully develop our RNAi technologies, | ||
| to obtain regulatory approval for our products, | ||
| to file and prosecute patent applications and to defend and assess patents to protect our technologies, | ||
| to retain qualified employees, particularly in light of intense competition for qualified scientists, | ||
| to manufacture products ourselves or through third parties, | ||
| to market our products, either through building our own sales and distribution capabilities or relying on third parties, and | ||
| to acquire new technologies, licenses, products or companies. |
We cannot assure you that any financing needed for the development of our business will be
available to us on acceptable terms or at all. If we cannot obtain additional financing in the
future, our operations may be restricted and we may ultimately be unable to continue to develop and
potentially commercialize our product candidates.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None
18
Table of Contents
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
Our annual meeting of shareholders was held on June 5, 2009. At the meeting, our shareholders
took the following actions:
(i) | To elect two directors to serve until the 2012 Annual Meeting of Stockholders |
For | Withheld | |||||||
Stephen S. Galliker |
[X] | [ ] | ||||||
Mark J. Ahn |
[X] | [ ] |
(ii) | To ratify the selection of BDO Seidman, LLP as our independent registered public accounting firm for the fiscal year ending December 31, 2009 |
For | Against | Abstain | ||
[X]
|
[ ] | [ ] |
(iii) | To approve an amendment to the 2007 Incentive Plan to increase the number of shares of common stock, par value $0.0001 per share, available for issuance under the plan by 1,000,000 shares. |
For | Against | Abstain | ||
[X] | [ ] | [ ] |
ITEM 5. OTHER INFORMATION
None
ITEM 6. EXHIBITS
19
Table of Contents
EXHIBIT INDEX
Exhibit | ||
Number | Description | |
3.1
|
Form of Amended and Restated Certificate of Incorporation of RXi Pharmaceuticals Corporation(1) | |
3.2
|
Form of Amended and Restated By-laws of RXi Pharmaceuticals Corporation(1) | |
10.1
|
Amendment to Employment Agreement between RXi Pharmaceuticals Corporation and Stephen J. DiPalma, dated May 29, 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 |
(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 | |
* | Indicates a management contract or compensatory plan or arrangement. |
20
Table of Contents
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: August 14, 2009 |
||||
21