SELLAS Life Sciences Group, Inc. - Quarter Report: 2010 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, 2010
OR
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File number 001-33958
RXi Pharmaceuticals Corporation
(Exact name of registrant as specified in its charter)
Delaware (State of incorporation) |
20-8099512 (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 9, 2010, RXi Pharmaceuticals Corporation had 18,372,759 shares of common stock,
$0.0001 par value, outstanding.
RXi PHARMACEUTICALS CORPORATION
FORM 10-Q QUARTER ENDED JUNE 30, 2010
FORM 10-Q QUARTER ENDED JUNE 30, 2010
INDEX
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PART I
ITEM 1. FINANCIAL STATEMENTS
RXi PHARMACEUTICALS CORPORATION
(A Development Stage Company)
(A Development Stage Company)
CONDENSED BALANCE SHEETS
(Amounts in thousands, except share data)
(Unaudited)
(Amounts in thousands, except share data)
(Unaudited)
June 30, | December 31, | |||||||
2010 | 2009 | |||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 5,093 | $ | 5,684 | ||||
Short term investments |
5,996 | | ||||||
Prepaid expenses and other current assets |
310 | 120 | ||||||
Total current assets |
11,399 | 5,804 | ||||||
Equipment and furnishings, net |
429 | 432 | ||||||
Deposits |
16 | 16 | ||||||
Total assets |
$ | 11,844 | $ | 6,252 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 329 | $ | 625 | ||||
Accrued expenses and other current liabilities |
1,203 | 1,077 | ||||||
Current maturities of capital lease obligations |
50 | 52 | ||||||
Fair value of common stock mandatorily redeemable for cash upon
the exercise of warrants |
785 | | ||||||
Fair value of common stock warrants potentially settleable in cash |
3,006 | 3,721 | ||||||
Total current liabilities |
5,373 | 5,475 | ||||||
Capital lease obligations, net of current maturities |
35 | 36 | ||||||
Total liabilities |
5,408 | 5,511 | ||||||
Commitments and contingencies (Note 6) |
||||||||
Stockholders equity: |
||||||||
Preferred stock, $0.0001 par value; 5,000,000 shares authorized;
no shares issued and outstanding |
| | ||||||
Common stock, $0.0001 par value; 50,000,000 shares
authorized;19,047,759 shares issued and 18,372,759 shares
outstanding and 16,207,625 shares issued and outstanding at June
30, 2010 and December 31, 2009, respectively |
3 | 2 | ||||||
Additional paid-in capital |
60,059 | 44,489 | ||||||
Deficit accumulated during the developmental stage |
(49,777 | ) | (43,750 | ) | ||||
Less treasury shares at cost, 675,000 and 0 shares at June 30,
2010 and December 31, 2009, respectively |
(3,849 | ) | | |||||
Total stockholders equity |
6,436 | 741 | ||||||
Total liabilities and stockholders equity |
$ | 11,844 | $ | 6,252 | ||||
The accompanying notes are an integral part of these financial statements.
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RXi PHARMACEUTICALS CORPORATION
(A Development Stage Company)
(A Development Stage Company)
CONDENSED STATEMENTS OF EXPENSES
(Amounts in thousands, except per share data)
(Unaudited)
(Amounts in thousands, except per share data)
(Unaudited)
Period from | ||||||||||||||||||||
January 1, 2003 | ||||||||||||||||||||
For the Three | For the Three | For the 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, | ||||||||||||||||
2010 | 2009 | 2010 | 2009 | 2010 | ||||||||||||||||
Expenses: |
||||||||||||||||||||
Research and development expense |
$ | 1,484 | $ | 1,817 | $ | 2,983 | $ | 3,011 | $ | 23,620 | ||||||||||
Research and development
employee stock based
compensation expense |
267 | 212 | 540 | 412 | 1,863 | |||||||||||||||
Research and development
non-employee stock based
compensation expense |
513 | 997 | 667 | 1,019 | 5,987 | |||||||||||||||
Fair value of common stock in
exchange for licensing rights |
| | | | 3,954 | |||||||||||||||
Total research and development
expenses |
2,264 | 3,026 | 4,190 | 4,442 | 35,424 | |||||||||||||||
General and administrative |
1,654 | 1,425 | 3,102 | 2,728 | 18,719 | |||||||||||||||
General and administrative
employee stock based
compensation |
646 | 532 | 1,418 | 969 | 6,262 | |||||||||||||||
Common stock warrants issued
for general and administrative
expenses |
190 | 92 | 500 | 826 | 2,076 | |||||||||||||||
Fair value of common stock
issued in exchange for general
and administrative expenses |
| | | 281 | 281 | |||||||||||||||
Total general and
administrative expenses |
2,490 | 2,049 | 5,020 | 4,804 | 27,338 | |||||||||||||||
Operating loss |
(4,754 | ) | (5,075 | ) | (9,210 | ) | (9,246 | ) | (62,762 | ) | ||||||||||
Interest income (expense) |
3 | (2 | ) | 2 | (2 | ) | 625 | |||||||||||||
Other income (expense) |
2,610 | (4 | ) | 3,181 | (4 | ) | 2,319 | |||||||||||||
Net loss |
$ | (2,141 | ) | $ | (5,081 | ) | $ | (6,027 | ) | $ | (9,252 | ) | $ | (59,818 | ) | |||||
Net loss per common share: |
||||||||||||||||||||
Basic and diluted loss per share |
$ | (0.12 | ) | $ | (0.37 | ) | $ | (0.35 | ) | $ | (0.67 | ) | N/A | |||||||
Weighted average common shares
outstanding: |
||||||||||||||||||||
Basic and diluted |
18,371,808 | 13,821,817 | 17,384,606 | 13,812,367 | N/A | |||||||||||||||
The accompanying notes are an integral part of these financial statements.
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RXi PHARMACEUTICALS CORPORATION
(A Development Stage Company)
(A Development Stage Company)
CONDENSED STATEMENTS OF CASH FLOWS
(Amounts in thousands)
(Unaudited)
(Amounts in thousands)
(Unaudited)
Period from | ||||||||||||
January 1, 2003 | ||||||||||||
(Date of | ||||||||||||
For the Six | For the Six | Inception) | ||||||||||
Months Ended | Months Ended | through | ||||||||||
June 30, | June 30, | June 30, | ||||||||||
2010 | 2009 | 2010 | ||||||||||
Cash flows from operating activities: |
||||||||||||
Net loss |
$ | (6,027 | ) | $ | (9,252 | ) | $ | (59,818 | ) | |||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||||||
Depreciation and amortization expense |
85 | 80 | 414 | |||||||||
Loss on disposal of equipment |
| 4 | 12 | |||||||||
Non-cash rent expense |
| | 29 | |||||||||
Accretion and receipt of bond discount |
| | 35 | |||||||||
Non-cash stock based compensation |
2,625 | 2,400 | 14,114 | |||||||||
Fair value of common stock warrants issued in exchange for services |
500 | 826 | 2,076 | |||||||||
Fair value of common stock issued as a commitment fee in connection
with the SEDA |
| 281 | 281 | |||||||||
Change in fair value of common stock warrants issued in connection with
various equity financings potentially settleable in cash |
(3,181 | ) | | (2,323 | ) | |||||||
Fair value of common stock issued in exchange for licensing rights |
| | 3,954 | |||||||||
Changes in assets and liabilities: |
||||||||||||
Prepaid expenses |
(190 | ) | (260 | ) | (310 | ) | ||||||
Accounts payable |
296 | 186 | 329 | |||||||||
Due to former parent |
| | (207 | ) | ||||||||
Accrued expenses and other current liabilities |
333 | 298 | 1,410 | |||||||||
Net cash used in operating activities |
(6,151 | ) | (5,437 | ) | (40,004 | ) | ||||||
Cash flows from investing activities: |
||||||||||||
Purchase of short-term investments |
(5,996 | ) | | (37,538 | ) | |||||||
Maturities of short-term investments |
| | 31,507 | |||||||||
Cash paid for purchase of equipment and furnishings |
(54 | ) | (46 | ) | (635 | ) | ||||||
Disposal of equipment and furnishings |
| (1 | ) | | ||||||||
Cash paid for lease deposit |
| | (45 | ) | ||||||||
Net cash used in investing activities |
(6,050 | ) | (47 | ) | (6,711 | ) | ||||||
Cash flows from financing activities: |
||||||||||||
Net proceeds from issuance of common stock |
15,235 | | 46,367 | |||||||||
Cash paid for repurchase of common stock |
(3,849 | ) | | (3,849 | ) | |||||||
Net proceeds from exercise of common stock options |
255 | | 611 | |||||||||
Repayments of capital lease obligations |
(31 | ) | (10 | ) | (87 | ) | ||||||
Cash advances from former parent company, net |
| | 8,766 | |||||||||
Net cash provided by (used in) financing activities |
11,610 | (10 | ) | 51,808 | ||||||||
Net increase (decrease) in cash and cash equivalents |
(591 | ) | (5,494 | ) | 5,093 | |||||||
Cash and cash equivalents at the beginning of period |
5,684 | 9,856 | | |||||||||
Cash and cash equivalents at end of period |
$ | 5,093 | $ | 4,362 | $ | 5,093 | ||||||
Supplemental disclosure of cash flow information: |
||||||||||||
Cash received during the period for interest |
$ | 2 | $ | | $ | 725 | ||||||
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 | ||||||
Fair value of warrants issued in connection with common stock
recorded as a cost of equity |
$ | 2,466 | $ | | $ | 5,329 | ||||||
Fair value of shares mandatorily redeemable for cash upon the
exercise of warrants |
$ | 785 | $ | | $ | 785 | ||||||
Allocation of management expenses |
$ | | $ | | $ | 551 | ||||||
Equipment and furnishings exchanged for common stock |
$ | | $ | | $ | 48 | ||||||
Equipment and furnishings acquired through capital lease |
$ | 28 | $ | | $ | 172 | ||||||
Value of restricted stock units issued in lieu of cash bonuses |
$ | 207 | $ | | $ | 207 | ||||||
Value of restricted stock units issued in lieu of bonuses
included in accrued expenses |
$ | 47 | $ | | $ | 47 | ||||||
Non-cash lease deposit |
$ | | $ | | $ | 50 | ||||||
The accompanying notes are an integral part of these financial statements.
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1. Description of Business and Basis of Presentation
RXi Pharmaceuticals Corporation (RXi or the Company) began operations in January 2007 as a
biopharmaceutical company pursuing the development of proprietary therapeutics based on RNA
Interference (RNAi) for the treatment of human diseases. By utilizing the Companys expertise in
RNAi and the RNAi therapeutic platform the Company has established, the Company believes it will be
able build a pipeline of therapeutics for the treatment of a number of diseases. The Company is
currently focusing its internal therapeutic development efforts in two main core areas, dermal
anti-scarring and retinal disorders, and is prepared to advance product candidates from these core
areas into early development and through clinical proof-of-concept. RXi may explore additional indications and proceed through
preclinical development, itself and with potential partners, in areas that are of strategic
interest to the company.
To date, RXis principal activities have consisted of conducting research and pre-clinical
development activities, acquiring key RNAi technologies and patent rights through exclusive,
co-exclusive and non-exclusive licenses, recruiting an RNAi-focused management and
scientific/clinical advisory team, capital raising activities and conducting business development
activities aimed at establishing development partnerships with pharmaceutical and larger
biotechnology companies. As the Company has not generated any revenues from inception through June
30, 2010, the Company is considered a development-stage company for financial reporting purposes.
The Company expects to incur significant operating losses for the foreseeable future while it
advances its future product candidates from discovery through pre-clinical studies and clinical
trials and seeks regulatory approval and potential commercialization, even if the Company is
collaborating with pharmaceutical and larger biotechnology companies. The Company also expects
general and administrative costs to increase as it recruits additional management and
administrative personnel. The Company will need to generate significant revenues to achieve
profitability and may never do so.
In the future, the Company will be dependent on obtaining funding from third parties such as
proceeds from the sale of equity, funded research and development payments, both government and
private grants and payments under partnership and collaborative agreements, to maintain its
operations. There is no guarantee that debt, additional equity or other funding will be available
to the Company on acceptable terms, or at all. If the Company fails to obtain additional funding
when needed, it would be forced to scale back or terminate its operations, or to seek to merge with
or to be acquired by another company.
The accompanying condensed financial statements have been prepared in accordance with the
rules and regulations of the Securities and Exchange Commission (SEC) and should be read in
conjunction with the Companys financial statements and the notes thereto for the year ended
December 31, 2009 included in the Companys Annual Report on Form 10-K filed with the SEC on March
31, 2010. Certain information and footnote disclosures normally included in financial statements
prepared in accordance with United States generally accepted accounting principles (U.S. GAAP)
have been condensed or omitted pursuant to such rules and regulations. The information presented as
of and for the three and six month periods ended June 30, 2010 and 2009, as well as the cumulative
financial information for the period from January 1, 2003 (date of inception) through June 30,
2010, is unaudited and has been prepared on the same basis as the audited financial statements and
includes all adjustments, consisting of only normal recurring adjustments, necessary for the fair
presentation of this information in all material respects. The results of any interim period are
not necessarily indicative of the results of operations to be expected for a full fiscal year.
There have been no material changes to the Companys significant accounting policies as disclosed
in the Companys Annual Report on Form 10-K for the year ended December 31, 2009. The Companys
operating results will fluctuate for the foreseeable future. Therefore, period-to-period
comparisons should not be relied upon as predictive of the results in future periods.
Uses of estimates in preparation of financial statements
The preparation of financial statements in accordance with U.S. GAAP requires management to
make estimates and assumptions that affect the reported amounts of assets and liabilities and
disclosure of contingent assets and
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liabilities at the date of the financial statements and the
reported amounts of revenues and expenses during the reporting period. Actual results could differ
from these estimates.
Derivative Financial Instruments
During the normal course of business, from time to time, the Company issues warrants and
options to vendors as consideration to perform services. It may also issue warrants as part of a
debt or equity financing. The Company does not enter into any derivative contracts for speculative
purposes.
The Company recognizes all derivatives as assets or liabilities measured at fair value with
changes in fair value of derivatives reflected as current period income or loss unless the
derivatives qualify for hedge accounting and are accounted for as such. In accordance with
Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) Topic
815-40, Derivatives and Hedging Contracts in Entitys Own Stock, the value of these warrants
is required to be recorded as a liability, as the holders have an option to put the warrants back
to the Company in certain events, as defined.
Obligations to Repurchase Shares of the Companys Equity Securities
In accordance with FASB ASC Topic 480-10, Distinguishing Liabilities from Equity, the
Company recognizes all obligations to repurchase shares of its equity securities that require or
may require the Company to settle the obligation by transferring assets, as liabilities or assets
in some circumstances measured at fair value with changes in fair value reflected as current period
income or loss and are accounted for as such.
2. Fair Value Measurements
In January, 2010, the FASB issued Accounting Standards Update (ASU) 2010-06, Improving
Disclosures about Fair Value Measurements, (ASU 2010-06). The standard amends FASB ASC Topic
820 Fair Value Measurements and Disclosures, (ASC 820) to require additional disclosures
related to transfers in and out of Levels 1 and 2 and for activity in Level 3 and clarifies other
existing disclosure requirements. The Company adopted ASU 2010-06 beginning January 1, 2010. This
update had no impact on the Companys financial statements.
Effective January 1, 2008, the Company implemented ASC 820 for the Companys financial assets
and liabilities that are re-measured and reported at fair value at each reporting period, and are
re-measured and reported at fair value at least annually using a fair value hierarchy that is
broken down into three levels. Level inputs are as defined as follows:
Level 1 quoted prices in active markets for identical assets or liabilities.
Level 2 other significant observable inputs for the assets or liabilities through
corroboration with market data at the measurement date.
Level 3 significant unobservable inputs that reflect managements best estimate of what
market participants would use to price the assets or liabilities at the measurement date.
The Company categorized its cash equivalents and short term investments as Level 1 hierarchy.
The valuation for Level 1 was determined based on a market approach using quoted prices in active
markets for identical assets. Valuations of these assets do not require a significant degree of
judgment. The Company categorized its warrants potentially settleable in cash and its common stock
mandatorily redeemable for cash upon the exercise of warrants as Level 2 hierarchies. The warrants
potentially settleable in cash are valued using the Black-Scholes method, using assumptions
consistent with our application of ASC 718 and are being marked to market each quarter-end until
they are completely settled. The common stock mandatorily redeemable for cash upon the exercise of
warrants is measured on a recurring basis and is determined by using the fixed monetary amount of
each warrant multiplied by assumptions regarding the expected number and timing of warrants to be exercised
under the conditions specified in the stock redemption agreement and discounted to present value
each quarter until they are completely settled. See footnote 7.
In accordance with the provisions of ASC 820 the Company has elected to defer implementation
of ASC 820, as it relates to its non-financial assets and liabilities that are recognized and
disclosed at fair value in the financial statements on a nonrecurring basis until the first quarter
of 2011. The adoption of ASC 820, as it relates to the Companys financial assets and liabilities
that are re-measured and reported at fair value at least annually did not
have an impact on the
Companys financial results.
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3. Short Term Investments
The Company purchased zero coupon U.S. Treasury Bills at a discount during the second quarter
of 2010. The securities mature in November 2010. The investments were classified as
held-to-maturity and are valued at amortized cost, which approximates fair value. The Company did
not have any short-term investments as of December 31, 2009.
4. Stock Based Compensation
The Company follows the provisions of the FASB ASC Topic 718, Compensation Stock
Compensation (ASC 718), which requires the measurement and recognition of compensation expense
for all stock based payment awards made to employees, non-employee directors, and consultants,
including employee stock options. Stock compensation expense based on the grant date fair value
estimated in accordance with the provisions of ASC 718 is recognized as an expense over the
requisite service period.
For stock options granted as consideration for services rendered by non-employees, the Company
recognizes compensation expense in accordance with the requirements of FASB ASC Topic 505-50,
Equity Based Payments to Non- Employees.
Non-employee option grants that do not vest immediately upon grant are recorded as an expense
over the vesting period of the underlying stock options. At the end of each financial reporting
period prior to vesting, the value of these options, as calculated using the Black-Scholes
option-pricing model, will be re-measured using the fair value of the Companys common stock and
the non-cash compensation recognized during the period will be adjusted accordingly. Since the fair
market value of options granted to non-employees is subject to change in the future, the amount of
the future compensation expense will include fair value re-measurements until the stock options are
fully vested.
The Company is currently using the Black-Scholes option-pricing model to determine the fair
value of all its option grants. For options grants issued in the three and six month period ended
June 30, 2010 and 2009, the following assumptions were used:
For the Three Months Ended June 30, | For the Six Months Ended June 30, | |||||||||||||||
2010 | 2009 | 2010 | 2009 | |||||||||||||
Weighted average risk-free interest rate |
3.21 | % | 3.49 | % | 3.06 | % | 2.25 | % | ||||||||
Weighted average expected volatility |
124.03 | % | 121.90 | % | 120.84 | % | 119.05 | % | ||||||||
Weighted average expected lives (years) |
9.29 | 8.98 | 7.26 | 7.4 | ||||||||||||
Weighted average expected dividend yield |
0.00 | % | 0.00 | % | 0.00 | % | 0.00 | % |
The weighted average fair value of options granted during the six month period ended June 30,
2010 and 2009 was $4.34 and $4.42 per share, respectively.
The weighted average fair value of options granted during the three month period ended June
30, 2010 and 2009 was $4.87 and $4.42 per share, respectively.
RXis expected common stock price volatility assumption is based upon the volatility of a
basket of comparable companies. The expected life assumptions for employee grants were based upon
the simplified method provided for under ASC 718-10, which averages the contractual term of RXis
options of ten years with the average vesting term of four years for an average of six years. The
expected life assumptions for non-employees were based upon the contractual term of the option. The dividend yield assumption of zero is based upon the fact
that RXi has never paid cash dividends and presently has no intention of paying cash dividends. The
risk-free interest rate used for each grant was also based upon prevailing short-term interest
rates. RXi has estimated an annualized forfeiture rate of 4.0% for options granted to its
employees, 2.1% for options granted to senior management and no forfeiture rate for the directors.
RXi will record additional expense if the actual forfeitures are lower than estimated and will
record a recovery of prior expense if the actual forfeiture rates are higher than estimated.
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The following table summarizes stock option activity from January 1, 2010 through June 30,
2010:
Total Number | Weighted Average | Aggregate | ||||||||||
of Shares | Exercise Price | Intrinsic Value | ||||||||||
Outstanding at January 1, 2010 |
3,582,339 | $ | 5.16 | $ | 143,500 | |||||||
Granted |
898,768 | 4.87 | | |||||||||
Exercised |
53,500 | 4.75 | 163,889 | |||||||||
Cancelled |
100,644 | 4.56 | | |||||||||
Outstanding at June 30, 2010 |
4,326,963 | $ | 5.12 | $ | 143,500 | |||||||
Options exercisable at June 30, 2010 |
2,755,201 | $ | 5.21 | $ | 17,938 | |||||||
The weighted average remaining contractual life of options outstanding and exercisable at June
30, 2010 was 7.85 years and 7.45 years, respectively.
The aggregate intrinsic values of outstanding and exercisable options at June 30, 2010 were
calculated based on the closing price of the Companys common stock on June 30, 2010 of $2.60 per
share less the exercise price of those shares. The aggregate intrinsic values of options exercised
was calculated based on the difference between the exercise price of the underlying awards and the
quoted price of the Companys common stock on the date of exercise.
5. Net Loss per Share
The Company accounts for and discloses net loss per common share in accordance with FASB ASC
Topic 260, Earnings per Share. Basic net loss per common share is computed by dividing net loss
attributable to common stockholders by the weighted average number of common shares outstanding.
Diluted net loss per common share is computed by dividing net loss attributable to common
stockholders by the weighted average number of common shares that would have been outstanding
during the period assuming the issuance of common shares for all potential dilutive common shares
outstanding. Potential common shares consist of shares issuable upon the exercise of stock options
and warrants. Because the inclusion of potential common shares would be anti-dilutive for all
periods presented diluted net loss per common share is the same as basic net loss per common share.
The following table sets forth the potential common shares excluded from the calculation of
net loss per common share because their inclusion would be anti-dilutive:
June 30, | ||||||||
2010 | 2009 | |||||||
Options to purchase common stock |
4,326,963 | 3,382,342 | ||||||
Warrants to purchase common stock |
2,100,642 | 332,500 | ||||||
Total |
6,427,605 | 3,714,842 | ||||||
6. License Agreements
As part of its business, the Company enters into numerous licensing agreements. These license
agreements with third parties often require milestone and royalty payments based on the progress of
the asset through development stages. Milestone payments may be required, for example, upon
approval of the product for marketing by a regulatory agency. In certain agreements, RXi is
required to make royalty payments based upon a percentage of sales.
The expenditures required under these arrangements may be material individually in the event
that the Company develops product candidates covered by the intellectual property licensed under
any such arrangement, and in the unlikely event that milestones for multiple products covered by
these arrangements were reached in the same period, the aggregate charge to expense could be
material to the results of operations. In addition, these arrangements often give RXi the
discretion to unilaterally terminate development of the product, which would allow RXi to avoid
making the contingent payments; however, RXi is unlikely to cease development if the compound
successfully achieves clinical testing objectives. The Companys contractual obligations as they
relate to these agreements that
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will require future cash payments relating to minimum annual
maintenance fees and milestone payments have not changed significantly from December 31, 2009.
7. Capital Transactions
On March 22, 2010, the Company entered into a placement agency agreement relating to a
proposed offering by the Company of new securities to potential investors. On March 23, 2010, the
Company entered into definitive agreements for the sale and issuance by the Company to certain
investors of 2,700,000 units, with each unit consisting of one share of the Companys common stock
and a warrant to purchase 0.20 of a share of the Companys common stock, at a purchase price of
$6.00 per unit (the 2010 Offering). The 2010 Offering closed on March 26, 2010. The Company
issued 540,000 warrants with an exercise price of $6.00 per share and that are exercisable
beginning on September 26, 2010 until their expiration on March 26, 2016. The Company raised gross
proceeds of approximately $16.2 million in the 2010 Offering and net cash proceeds, after deducting
the placement agent fees and other offering expenses payable by the Company, of approximately $15.2
million.
As part of the 2010 Offering, RXi entered in a stock redemption agreement whereby the
Company was required to use 25% of the net proceeds from the 2010 Offering to repurchase from CytRx
Corporation (CytRx) 675,000 shares of the Companys common stock held by CytRx (CytRx shares).
The Company repurchased such shares on March 29, 2010. The values of the shares at the date of
repurchase totaling $3,849,000 were recorded at cost and have been included in treasury stock in
the accompanying balance sheet at June 30, 2010. The Company is also required to use 25% of the
proceeds from the exercise of warrants issued in the 2010 Offering to repurchase from CytRx a
number of CytRx Shares equal to 25% of shares issued upon the exercise of such warrants. Subject to
the satisfaction of certain closing conditions, if any warrant issued in the 2010 Offering is
exercised, on the first business day after the exercise of such warrant.
Shares of common stock that are mandatorily redeemable under the stock redemption agreement
upon the exercise of warrants issued in the 2010 Offering, were determined to embody an obligation
that may require the Company to settle the obligation by transferring assets, and as such, shall be
classified as a liability. The fair value of the common stock potentially redeemable under the
stock redemption agreement totaling $785,000 was recorded as a liability and a cost of equity and
was determined using the fixed monetary amount of each warrant multiplied by assumptions regarding
the number and timing of warrants to be exercised. Consistent with the Companys assumptions upon
issuance, we currently believe that the warrant shares will be exercised within the twelve months
after they become exercisable in September 2010. Consequently the fair value of the obligation is
$810,000 which is the maximum amount of cash that would be received by the Company under the
conditions specified in the stock redemption agreement, if all of the shares required to be
redeemed were repurchased discounted over one year at a rate of 3.18%.
Certain warrants issued in connection with the 2010 Offering were determined not to be indexed
to the Companys common stock as they are potentially settleable in cash. The fair value of the
warrants at the dates of issuance totaling $2,466,000 was recorded as a liability and a cost of
equity and was determined by the Black-Scholes option pricing model. Due to the fact that we have
limited trading history, our expected stock volatility assumption is based on a combination of
implied volatilities of similar entities whose share or option prices are publically traded. The
Company used a weighted average expected stock volatility of 119.49%. The expected life assumption
is based on the contract term of 6.5 years. The dividend yield of zero is based on the fact that
we have no present intention to pay cash dividends. The risk free rate of 3.22% used for the
warrant is equal to the zero coupon rate in effect at the time of the grant. The decrease in the
fair value of the warrants from the date of issuance to June 30, 2010 is $1,302,000 and has been
included in other income and expense in the accompanying condensed statements of expenses for the
six months ended June 30, 2010. The fair value of the warrants at June 30, 2010 of $1,164,000 is
included as a current liability in the accompanying balance sheets and was determined by the
Black-Scholes option pricing model. Due to the fact that we have limited trading history, our
expected stock volatility assumption is based on a combination of implied volatilities of similar entities whose share
or option prices are publically traded. The Company used a weighted average expected stock
volatility of 123.45%. The expected life assumption is based on the contract term of 6.25 years.
The dividend yield of zero is based on the fact that we have no present intention to pay cash
dividends. The risk free rate of 2.29% used for the warrant is equal to the zero coupon rate in
effect on the date of the re-measurement.
Certain warrants issued in connection with a registered direct stock offering on August 3,
2009 (the 2009 Offering) were determined not to be indexed to the Companys common stock as they
are potentially settleable in
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cash. The fair value of the warrants at the dates of issuance
totaling $2,863,000 was recorded as a liability and a cost of equity and was determined by the
Black-Scholes option pricing model. Due to the fact that we have limited trading history, our
expected stock volatility assumption is based on a combination of implied volatilities of similar
entities whose share or option prices are publically traded. The Company used a weighted average
expected stock volatility of 122.69%. The expected life assumption is based on the contract term
of five years. The dividend yield of zero is based on the fact that we have no present intention
to pay cash dividends. The risk free rate of 1.72% used for the warrant is equal to the zero
coupon rate in effect at the time of the grant. The decrease in the fair value of the warrants from
the date of issuance to June 30, 2010 is $1,021,000 of which $1,879,000 has been included in other
income and expense in the accompanying condensed statements of expenses for the six months ended
June 30, 2010. The fair value of the warrants at June 30, 2010 of $1,842,000 is included as a
current liability in the accompanying balance sheets and was determined by the Black-Scholes option
pricing model. Due to the fact that we have limited trading history, our expected stock volatility
assumption is based on a combination of implied volatilities of similar entities whose share or
option prices are publically traded. The Company used a weighted average expected stock volatility
of 123.45%. The expected life assumption is based on the contract term of 4 years. The dividend
yield of zero is based on the fact that we have no present intention to pay cash dividends. The
risk free rate of 1.11% used for the warrant is equal to the zero coupon rate in effect on the date
of the re-measurement. The most significant factor causing the decline in fair value is the
decline in the Companys stock price.
8. Recent Accounting Pronouncements
In April 2010, the FASB issued ASU 2010-17 which provides guidance in applying the milestone
method of revenue recognition to research or development arrangements. Under this guidance,
management may recognize revenue contingent upon the achievement of a milestone in the period in
which the milestone is achieved only if the milestone meets all the criteria within the guidance to
be considered substantive. This standard is effective on a prospective basis for research and
development milestones achieved in fiscal years beginning on or after June 15, 2010. The adoption
of ASU 2010-17 did not have a material impact on the Companys financial statements.
In June 2009, the FASB issued FASB ASC Topic 810-10,
Consolidations (ASC 810-10), which
amends the consolidation guidance applicable to variable interest entities and was effective as of
January 1, 2010. The adoption of ASC Topic 810-10 did not have a material impact on the Companys
financial statements.
In June 2009, the FASB
issued FASB ASC Topic 860-10, Transfers and Servicing of Financial
Assets (ASC 860-10), which eliminates the concept of a qualifying special-purpose entity,
changes the requirements for derecognizing financial assets, and requires additional disclosures in
order to enhance information reported to users of financial statements by providing greater
transparency about transfers of financial assets, including securitization transactions, and an
entitys continuing involvement in and exposure to the risks related to transferred financial
assets. This statement is effective for fiscal years beginning after November 15, 2009. The
adoption of ASC Topic 860-10 did not have a material impact on the Companys financial statements.
9. Subsequent Events
The Company evaluated all events or transactions that occurred after June 30, 2010 up through the
date these condensed financial statements were issued. Other than what is disclosed below, during
this period, the Company did not have any material recognizable or unrecognizable subsequent
events.
In July 2010, the National Institute of Allergy and Infectious Diseases (NIAID), part of the
National Institutes of Health (NIH), awarded the Company an Advanced Technology Small Business
Innovation Research (SBIR) grant to fund the pre-clinical development of RNAi therapeutics using
the Companys novel, proprietary therapeutic platform, which includes both novel RNAi compounds and
advanced delivery technologies. The NIAID SBIR grants are for advanced technology projects that
require a longer award period and greater award amount than those routinely allowed under the SBIR
program. Advanced Technology is defined by NIAID as a clearly identified product or service
that requires approval of the Food and Drug Administration and is within the mission of NIAID.
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The Company was awarded approximately $300,000 per year for this 2 year Phase I grant with the
first year being awarded for 2010, and the second year for 2011 subject to customary conditions.
Additional funding of up to $1 million per year over a time period of up to 3 years may be
requested for Phase II. The award number is R43AI091045. The Company will recognize
revenue under government cost reimbursement contracts as it performs the underlying research and
development activities.
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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 June 30, 2010 and
results of operations for three and six months ended June 30, 2010 and 2009 should be read in
conjunction with managements discussion and analysis of financial condition and results of
operations included in our Annual Report on Form 10-K for the year ended December 31, 2009 which
was filed with the SEC on March 31, 2010.
The discussion and analysis below includes certain forward-looking statements related to
future operating losses and our potential for profitability, the sufficiency of our cash resources,
our ability to obtain additional equity or debt financing, possible partnering or other strategic opportunities for the development of
our products, as well as other statements related to the progress and timing of product
development, present or future licensing, collaborative or financing arrangements or that otherwise
relate to future periods, which are all forward-looking statements as defined by the Private
Securities Litigation Reform Act of 1995. These statements represent, among other things, the
expectations, beliefs, plans and objectives of management and/or assumptions underlying or
judgments concerning the future financial performance and other matters discussed in this document.
The words may, will, should, plan, believe, estimate, intend, anticipate,
project, and expect and similar expressions are intended to identify forward-looking
statements. All forward-looking statements involve certain risks, uncertainties and other factors
described elsewhere in our Annual Report on Form 10-K for the year
ended December 31, 2009, that
could cause our actual results of operations, performance, financial position and business
prospects and opportunities for this quarter and the periods that follow to differ materially from
those expressed in, or implied by, those forward-looking statements. We caution investors not to
place significant reliance on the forward-looking statements contained in this report. These
statements, like all statements in this report, speak only as of the date of this report (unless
another date is indicated) and we undertake no obligation to update or revise forward-looking
statements.
Overview
We are a discovery-stage biopharmaceutical company pursuing proprietary therapeutics based on
RNA interference (RNAi), a naturally occurring cellular mechanism that has the potential to
effectively and selectively interfere with, or silence, expression of targeted disease-associated
genes. By utilizing our expertise in RNAi and the comprehensive RNAi therapeutic platform that we
have established, we believe we will be able to discover and develop lead compounds and progress
them into and through clinical development for potential commercialization more efficiently than
traditional drug development approaches.
We were formed in 2006 by CytRx Corporation (CytRx) and four prominent RNAi researchers,
including Dr. Craig Mello, who was awarded the 2006 Nobel Prize in Medicine for his co-discovery of
RNAi. From 2003 through 2006, CytRx sponsored therapeutic RNAi research at the University of
Massachusetts Medical School (UMMS) and Massachusetts General Hospital. We commenced operations
in January 2007 after CytRx contributed to us its portfolio of RNAi therapeutic assets in exchange
for approximately 7.04 million shares of our common stock. These assets consisted primarily of
RNAi licenses and related intellectual property, and a nominal amount of equipment. The cost of the
licenses had previously been expensed by CytRx as in-process research and development and was
recorded in the predecessor financial statements at cost.
Our proprietary therapeutic platform is comprised of two main components:
| Novel RNAi Compounds, referred to as rxRNA compounds, that are distinct from, and we believe convey significant advantages over classic siRNA (conventionally-designed small interfering RNA compounds), and offer many of the properties that we believe are important to the clinical development of RNAi-based drugs. We have developed a number of unique forms of rxRNA compounds, all of which have been shown to be highly potent both in vitro and in vivo. These RNAi compounds include rxRNAoriTM, rxRNAsoloTM and sd-rxRNATM, or self delivering RNA. Based on our research we believe that these different, novel siRNA configurations have various advantages for therapeutic use. These advantages include high potency, increased resistance to nucleases and off-target effects, and, in the case of the sd-rxRNA compounds, access to cells and tissues with no additional formulation required. | ||
| Advanced Delivery Technologies, may enable the delivery of our rxRNA compounds to treat a variety of acute and chronic diseases using both local and systemic approaches, potentially providing a competitive advantage in the development of many RNAi therapeutic compounds. Our suite of delivery technologies is comprised of delivery vehicles, which can be combined with various rxRNA compounds, as well as sd-rxRNA compounds, which are chemically modified and have the unique property of entering cells and tissues to effect silencing without the need for any additional delivery vehicle. This suite of delivery technologies has broad applications for multiple therapeutic areas targeting both local and systemic applications. |
Therapeutic Programs
Our therapeutic platform has the potential to be broadly applicable to multiple therapeutic
areas. We intend to focus our internal therapeutic development efforts in two main core areas,
dermal anti-scarring and retinal disorders. By utilizing our expertise in RNAi and the RNAi
technology platform we have built, we believe we will be able to discover and develop lead
compounds and progress them into clinical development more efficiently than traditional drug
discovery approaches. We are prepared to advance product candidates from these core areas into
early development and through clinical proof-of-concept. We will may also explore additional
indications and proceed through preclinical development, ourselves and with potential partners, in
areas that are of strategic interest to us, including in the areas of neurological disorders and oncology as discussed below.
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Core Areas
Dermatology Anti-Scarring
Our sd-rxRNA compounds in preliminary pre-clinical models using local administration to the
skin have shown robust delivery and effective target silencing. Anti-scarring is an attractive therapeutic indication with clear development precedent, limited competition for effective therapies, and substantial market potential. We intend to select an
anti-scarring development candidate in 2010 and file an IND in 2011. Our success with RNAi
therapeutics in anti-scarring may provide additional opportunities in other dermatology
applications as well as in anti-fibrotic indications including pulmonary fibrosis, liver fibrosis,
acute spinal cord injury, ocular scarring and restenosis.
Ophthalmology Retinal Disorders
We have shown data demonstrating unprecedented delivery and effective target silencing in the
retina with sd-rxRNA compounds. By applying our unique technology with existing and novel targets,
and potentially multiple targets, we believe we have the potential to develop next generation
treatments for retinal disorders. Further, we believes that there is opportunity to potentially
improve on existing therapies, extend the time required between doses and utilize new modes of
administration for delivery to the eye. We intend to select a retinal disorder development
candidate in 2011.
Strategic Interest
Neurology Spinal Cord
We are exploring indications accessible by spinal cord delivery of sd-rxRNA. Direct dosing to
the spinal cord could be used for severe central nervous system or spinal cord diseases in both
orphan and non-orphan indications. We may also be able to `leverage early proof-of-concept studies
and collaborations to advance programs in this area. We intend to advance potential candidates
through preclinical studies as well as seek potential partners to help support further development.
Oncology Liver Metastases and Hepatocellular Carcinoma
In the area of oncology, we will be concentrating initially on liver metastases and
hepatocellular carcinoma using systemic delivery of sd-rxRNA or other rxRNA compounds in
combination with delivery vehicles. Given the emerging emphasis on multi-targeted therapies for
cancer, we have the ability to develop RNAi compounds against multiple gene targets to generate
effective combination treatments. The unique features of sd-rxRNA may offer a new alternative to
treating cancers and could lead to attractive product candidates to further advance in conjunction
with partners.
Financial Overview
To date, our principal our activities have consisted of conducting discovery research and
pre-clinical development activities utilizing our RNAi therapeutic platform, acquiring RNAi
technologies and patent rights through exclusive, co-exclusive and non-exclusive licenses,
recruiting an RNAi-focused management and scientific/clinical advisory team, capital raising
activities and conducting business development activities aimed at establishing research and
development partnerships with pharmaceutical and larger biotechnology companies.
We have not generated revenue to date and may not generate revenue in the foreseeable future,
if ever. We expect to incur significant operating losses as we advance our product candidates
through the drug development and regulatory process. In addition to increasing research and
development expenses, we expect general and
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administrative costs to increase as we add personnel.
We will need to generate significant revenues to achieve profitability and might never do so. In
the absence of product revenues, our potential sources of operational funding are expected to be
the proceeds from the sale of equity, funded research and development payments, both government and
private grants and payments under partnership and collaborative agreements. As we have not
generated any revenues since inception through June 30, 2010, we are considered a development stage
company for financial reporting purposes.
We believe that our existing cash and short term investments should be sufficient to fund our
operations through at least the first half of fiscal 2011. In addition, we also have funds
available to us upon the issuance of shares of our common stock under the Standby Equity
Distribution Agreement (the SEDA) that we entered into on January 30, 2009 with YA Global Master
SPV Ltd. (YA Global) which expires on January 30, 2011. In the future, we will be dependent on
obtaining funding from third parties such as proceeds from the sale of equity, funded research and
development payments, both government and private grants and payments under partnership and
collaborative agreements, in order to maintain our operations and meet our obligations to
licensors. There is no guarantee that debt, additional equity or other funding will be available to
us on acceptable terms, or at all. If we fail to obtain additional funding when needed, we would be
forced to scale back, or terminate, our operations or to seek to merge with or to be acquired by
another company
Results of Operations
For the Three and Six Months Ended June 30, 2010, and June 30, 2009
Operating Results
We reported a loss from operations of $4,754,000 which includes $1,616,000 of non-cash equity
based compensation for the three months ended June 30, 2010 compared with a loss from operations of
$5,075,000 which includes $1,833,000 of non-cash equity compensation in 2009. The decrease in loss
of $321,000, or 6%, was due primarily to $217,000 decrease in non-cash equity compensation and a
$333,000 decrease in research and development expenses offset by an increase of $229,000 in general
and administrative expenses, as noted below.
We reported a loss from operations of $9,210,000 which includes $3,125,000 of non-cash equity
based compensation for the six months ended June 30, 2010 compared with a loss from operations of
$9,246,000 which includes $3,507,000 of non-cash equity based compensation in 2009. The decrease
in loss of $36,000, or 0.4%, was due primarily to $382,000 decrease in non-cash equity compensation
and a $28,000 decrease in research and development expenses offset by an increase of $374,000 in
general and administrative expenses, as noted below.
For the three months ended June 30, 2010, our net loss was approximately $2,141,000 compared
with a net loss of $5,081,000 for the three months ended June 30, 2009. The decrease in net loss
of $2,940,000, or 58%, includes the decrease in the loss from operations of $321,000 and a
decrease of $2,619,000 in non-cash other income related to the change in fair value of common stock
warrants issued with several financing transactions. The result is a net loss per share of $0.12
and $0.37, for the three months ended June 30, 2010 and 2009, respectively. Reasons for the
variations in the losses between the two periods are discussed below.
For the six months ended June 30, 2010, our net loss was approximately $6,027,000 compared
with a net loss of $9,252,000 for the six months ended June 30, 2009. The decrease in net loss of
$3,225,000, or 35%, includes the decrease in loss from operations of $36,000 offset by the increase
in other income of $3,189,000 in non-cash other income related to the change in fair value of
warrants issued with several financing transactions. The result is a net
loss per share of $0.35 and $0.67, for the six months ended June 30, 2010 and 2009,
respectively. Reasons for the variations in the losses between the two periods are discussed
below.
Research and Development Expense
Research and development expense consists primarily of compensation-related costs for our
employees dedicated to research and development activities and for our Scientific Advisory Board
(SAB) members as well as licensing fees, patent prosecution costs, and the cost of lab supplies
used in our research and development programs. We expect research and development expenses to
increase as we expand our discovery and development activities for RNAi therapeutics.
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Total research and development expenses were approximately $2,264,000 for the three months
ended June 30, 2010, compared with $3,026,000 for the three months ended June 30, 2009. The
decrease of $762,000 or 25%, was primarily due to an decrease of $484,000 in non-employee non-cash
stock based compensation and $333,000 decrease in research and development cash expenses related to
the timing of patent application and prosecution on internal discoveries offset by an increase in
costs associated with employee non-cash stock based compensation of $55,000 due to an increase in
headcount.
Total research and development expenses were approximately $4,190,000 for the six months ended
June 30. 2010, compared with $4,442,000 for the six months ended June 30, 2009. The decrease of
$252,000 or 6% was primarily due to a decrease of $352,000 in non-employee non-cash stock based
compensation and $28,000 decrease in research and development cash expenses related to the timing
of patent application and prosecution on internal discoveries offset by an increase of $128,000 in
costs associated with employee non-cash stock based compensation.
General and Administrative Expense
General and administrative expenses include compensation-related costs for our employees
dedicated to general and administrative activities, legal fees, audit and tax fees, consultants and
professional services, and general corporate expenses.
General and administrative expenses were approximately $2,490,000 for the three months ended
June 30, 2010, compared with $2,049,000 for the three months ended June 30, 2009. The increase of
$441,000, or 22%, was primarily due to a $114,000 increase in non-cash employee stock based
compensation and a $98,000 increase due to non-cash stock based compensation expense related to a
warrant issued for business advisory services. Excluding these non-cash items general and
administration expense were approximately $1,654,000 for the three months ended June 30, 2010,
compared with $1,425,000 for the three months ended June 30, 2009, the increase of $229,000 was
primarily due to an increase in headcount.
General and administrative expenses were approximately $5,020,000 for the six months ended
June 30, 2010, compared with $4,804,000 for the six months ended June 30, 2009. The increase of
$216,000, or 4%, was primarily due to a $449,000 increase in non-cash stock based compensation offset by
a $607,000 decrease due to non-cash stock based compensation expense related to a warrant issued
for business advisory services as well as the fair value of common stock issued as a commitment fee
for the SEDA for the six months ended June 30, 2009. Excluding these non-cash items, general and
administration expense were approximately $3,102,000 for the six months ended June 30, 2010,
compared with $2,728,000 for the six months ended June 30, 2009, the increase of $374,000 was
primarily due to an increase in headcount.
Interest Income
Interest income was negligible for the three and six months ended June 30, 2010 and 2009. The
key objectives of our investment policy are to preserve principal and ensure sufficient liquidity,
so our invested cash may not earn as high a level of income as longer-term or higher risk
securities, which generally have less liquidity and more volatility. The interest rates available
on lower risk, shorter-term investments in todays market are lower than rates available in the
prior period.
Other Income/Expense
Other income and expense for the three months ended June 30, 2010 includes $2,610,000 in
non-cash income related to a gain on the change in the fair value of common stock warrants issued
in connection with several financing transactions in 2009 and 2010.
Other income and expense for the six months ended June 30, 2010 includes $3,181,000 in
non-cash income related to a gain on the change in the fair value of common stock warrants issued
in connection with equity financings in 2009 and 2010. The fair value of the warrants
at June 30, 2010 of $3,006,000 is included as a current liability in the accompanying balance
sheets and was determined by the Black-Scholes option pricing model.
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Liquidity and Capital Resources
During 2009 and to date in 2010, we have entered into the following significant financing
transactions:
On January 30, 2009, we entered into the SEDA, pursuant to which we may, at our option
over a two-year period, ending on January 30, 2011, periodically sell to YA Global shares of our
common stock, for a total purchase price of up to $25.0 million. To date we have not sold any
shares under the SEDA.
On August 4, 2009, we closed the 2009 Offering in which we sold 2,385,715 shares of our
common stock and warrants to purchase 954,286 shares of our common stock at an exercise price of
$4.50 per share resulting in approximately $7.8 million in net proceeds after deducting the
placement agent fee and offering expenses.
On March 26, 2010,
we closed the 2010 Offering pursuant to which we sold to certain
investors 2,700,000 units for $6.00, which consisted of one share of common stock and a warrant to
purchase 0.20 shares of common stock with an exercise price of $6.00 per share. The financing
provided approximately $15.2 million in net proceeds to us after deducting the placement agent fee
and offering expenses. Pursuant to a stock redemption agreement between us and CytRx dated March
22, 2010, we were required to use 25% of the net proceeds from the 2010 Offering to repurchase from
CytRx a number of shares of our common stock held by CytRx equal to 25% of the shares sold by us in
the 2010 Offering. We are also required to use 25% of the proceeds from the exercise of warrants
issued in the 2010 Offering to repurchase from CytRx a number of shares of our common stock held by
CytRx equal to 25% of the shares issued upon the exercise of such warrants. As required by the
agreement with CytRx, on March 29, 2010, we repurchased 675,000 shares of our common stock from
CytRx for an aggregate price of approximately $3.8 million. We estimate that we will repurchase an
additional 135,000 shares of our common stock from CytRx for an aggregate price of $0.8 million if
all of the warrants issued in the offering are exercised.
We have not generated any revenues since inception nor are any revenues expected for the
foreseeable future. We expect to incur significant operating losses for the foreseeable future
while we advance our future product candidates from discovery through pre-clinical studies and
clinical trials and seek regulatory approval and potential commercialization, even if we are
collaborating with pharmaceutical and larger biotechnology companies. In addition to these
increasing research and development expenses, we expect general and administrative costs to
increase as we recruit additional management and administrative personnel.
We believe that our existing cash and short term investments should be sufficient to fund
our operations through at least the first half of 2011. In addition, we also have funds available
to us upon the issuance of shares of our common stock under the SEDA which expires on January 30,
2011. In the future, we will be dependent on obtaining funding from third parties such as proceeds
from the sale of equity, funded research and development payments, both government and private
grants and payments under partnership and collaborative agreements, in order to maintain our
operations and meet our obligations to licensors. There is no guarantee that debt, additional
equity or other funding will be available to us on acceptable terms, or at all. If we fail to
obtain additional funding when needed, we would be forced to scale back, or terminate, our
operations or to seek to merge with or to be acquired by another company.
Net Cash Flow from Operating Activities
Cash used in operating activities is adjusted for non-cash items to reconcile net loss to net
cash used in or provided by operating activities. These non-cash adjustments consist primarily of
stock-based compensation, change in fair value of common stock warrants issued in connection
with various equity financings potentially settleable in cash, and depreciation and
amortization. Net cash used in operating activities was approximately $6,151,000 for the six
months ended June 30, 2010, compared with $5,437,000 for the six months ended June 30, 2009.
Cash used in operations in 2010 consisted primarily of a net loss of $6,027,000, less the add
back of non-cash items of $29,000, of which $3,181,000 related to the change in fair value of
common stock warrants issued in connection with various equity financings, $2,625,000
related to non-cash stock based compensation, $500,000 related to common stock warrant expense in
exchange for services, $85,000 related to depreciation and amortization expense and $153,000
related to changes in current assets and liabilities.
We expect that we will require significant amounts of cash to fund our operating activities
for the foreseeable future as we continue to develop and advance our research and development
initiatives. The actual amount of overall
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expenditures will depend on numerous factors, including
the timing of expenses, the timing and terms of collaboration agreements or other strategic
transactions, if any, and the timing and progress of our research and development efforts.
Net Cash Flow from Investing Activities
Net cash used in
investing activities was $6,050,000 for the six months ended
June 30, 2010, compared with net cash used in investing activities of $47,000 for the six months
ended June 30, 2009. The increase of $6,003,000 in cash used in investing activities
was primarily due to the purchase of new equipment in the first quarter of 2010, combined with the
purchase of United States Treasury notes in the second quarter of 2010.
Net Cash Flow from Financing Activities
Net cash provided by financing activities was $11,610,000 for the six months ended June 30,
2010, compared with net cash used in financing of $10,000 for the six months ended June 30, 2009.
Cash provided in 2010 was primarily due to net proceeds from the issuance of common stock to
institutional investors in the first quarter of 2010. There were no such financing activities in
the first two quarters of 2009.
Off-Balance Sheet Arrangements
We have not entered into off-balance sheet financing, other than operating leases, license
agreements and the SEDA.
Critical Accounting Policies and Estimates
In our Annual Report on Form 10-K for the year ended December 31, 2009, we disclosed our
critical accounting policies and estimates upon which our financial statements are derived. There
have been no changes to these policies since December 31, 2009. Readers are encouraged to review
these disclosures in conjunction with the review of this quarterly report on Form 10-Q.
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ITEM 4. CONTROLS AND PROCEDURES
Disclosure Controls and Procedures
As of the end of the period covered by this quarterly report on Form 10-Q, our Chief Executive
Officer and Principal Accounting Officer (the Certifying Officers), evaluated the effectiveness
of our disclosure controls and procedures. Disclosure controls and procedures are controls and
procedures designed to reasonably assure that information required to be disclosed in our reports
filed under the Securities Exchange Act of 1934 (the Exchange Act), such as this Form 10-Q, is
recorded, processed, summarized and reported within the time periods specified in the SEC rules and
forms. Disclosure controls and procedures are also designed to reasonably assure that such
information is accumulated and communicated to our management, including the Certifying Officers,
as appropriate to allow timely decisions regarding required disclosure. Based on these evaluations,
the Certifying Officers have concluded, that, as of the end of the period covered by this quarterly
report on Form 10-Q:
(a) | our disclosure controls and procedures were effective to provide reasonable assurance that information required to be disclosed by us in the reports we file or submit under the Exchange Act was recorded, processed, summarized and reported within the time periods specified in the SECs rules and forms; and |
(b) | our disclosure controls and procedures were effective to provide reasonable assurance that material information required to be disclosed by us in the reports we file or submit under the Exchange Act was accumulated and communicated to our management, including the Certifying Officers, as appropriate to allow timely decisions regarding required disclosure. |
Changes in Internal Control over Financial Reporting
There has not been any change in our internal control over financial reporting that occurred
during the quarterly period ended June 30, 2010 that has materially affected, or is reasonably
likely to materially affect, our internal control over financial reporting.
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RXi PHARMACEUTICALS CORPORATION
PART II OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
None
ITEM 1.A RISK FACTORS
Our business is subject to numerous risks. We caution you that the following important
factors, among others, could cause our actual results to differ materially from those expressed in
forward- looking statements made by us or on our behalf in filings with the SEC, press releases,
communications with investors and oral statements. Any or all of our forward-looking statements in
this quarterly report on Form 10-Q and in any other public statements we make may turn out to be
wrong. They can be affected by inaccurate assumptions or by known or unknown risks and
uncertainties. Many factors mentioned in the discussion below will be important in determining
future results. Consequently, no forward-looking statement can be guaranteed. Actual future results
may vary materially from those anticipated in forward-looking statements. When used in this Form
10-Q, the words believe, anticipate, expect, estimate, intend, plan, project, will
be, will continue, will result, seek, could, may, might and similar expressions are
intended to identify forward-looking statements. We explicitly disclaim any obligation to update
any forward-looking statements to reflect events or circumstances that arise after the date hereof.
You are advised, however, to consult any further disclosure we make in our reports filed with the
SEC.
Risks Relating to RXis Business and Industry
The approach we are taking to discover and develop novel therapeutics using RNAi is unproven
and may never lead to marketable products.
The scientific discoveries
that form the basis for our efforts to discover and develop new
drugs are relatively new. The RNAi technologies that we have licensed or have created internally
and that we intend to develop have not yet been clinically tested by us, nor are we aware of any
clinical trials for efficacy having been completed by third parties involving these technologies. To
date, neither we nor any other company has received regulatory approval to market therapeutics
utilizing RNAi and a number of clinical trials of third parties RNAi technology has been
unsuccessful. The scientific evidence to support the feasibility of developing drugs based on these
discoveries is both preliminary and limited. Successful development of RNAi-based products by us
will require solving a number of issues, including providing suitable methods of stabilizing the
RNAi material and delivering it into target cells in the human body. We may spend large amounts of
money trying to solve these issues and never succeed in doing so. In addition, any compounds that
we develop may not demonstrate in patients the chemical and pharmacological properties ascribed to
them in laboratory studies, and they may interact with human biological systems in unforeseen,
ineffective or even harmful ways.
Further, our exclusive focus on RNAi technology for developing products as opposed to
multiple, more proven technologies for drug development increases the risk associated with our
business. If we are not successful in developing a product candidate using RNAi technology, we may
not be able to identify and successfully implement an alternative product development strategy.
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 using RNAi technologies, including for at least some of the disease
indications we have been focusing our efforts on to date. Companies working in the RNAi area
include: Alnylam Pharmaceuticals, Marina Biotech, Tacere Therapeutics, Benitec, OPKO Health,
Silence Therapeutics, Quark Pharmaceuticals, Rosetta Genomics, Lorus Therapeutics, Tekmira
Pharmaceuticals Corporation, Calando Pharmaceuticals, Regulus Therapeutics, and Santaris
Pharmaceuticals, as well as a number of the large pharmaceutical companies. In addition, a number
of companies are developing therapeutics for the same diseases we are targeting using technologies
other than RNA interference, and, for some of these diseases, there are existing therapeutics being
marketed currently. Most of these competitors
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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.
A number of our competitors have already commenced clinical testing of RNAi product candidates and
may be more advanced than are we in the process of developing products. 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 may not be able to establish or maintain the third party relationships that are necessary to
develop or potentially commercialize some or all of our product candidates.
We expect to depend on collaborators, partners, licensees, clinical research organizations and
other third parties to support our discovery efforts, to formulate product candidates, to
manufacture our product candidates, and to conduct clinical trials for some or all of our product
candidates. We cannot guarantee that we will be able to successfully negotiate agreements for or
maintain relationships with collaborators, partners, licensees, clinical investigators and other
third parties on favorable terms, if at all. Our ability to successfully negotiate such agreements
will depend on, among other things, potential partners evaluation of the superiority of our
technology over competing technologies and the quality of the pre-clinical data that we have
generated, the perceived risks in developing RNAi therapeutics as a new form of therapeutic. In
addition, we and other companies operating in the RNAi field receive notices from third parties
from time to time that our or such other companies technology or product candidates infringe or
may infringe the intellectual property rights of those third parties. The assertion by third
parties that our activities or product candidates infringe upon their intellectual property rights
may adversely affect our ability to secure strategic partners or licensees for our technology or
product candidates or our ability to secure or maintain manufacturers for our compounds. If we are
unable to obtain or maintain these agreements, we may not be able to clinically develop, formulate,
manufacture, obtain regulatory approvals for or commercialize our product candidates. Under certain
license agreements that we have already entered into, we have minimum dollar amounts per year that
we are obligated to spend on the development of the technology we have licensed from our contract
partners. If we fail to meet this requirement under any of our licenses that contain such
requirements or any other obligations under these licenses, we may be in breach of our obligations
under such agreement, which may result in the loss of the technology licensed. We cannot
necessarily control the amount or timing of resources that our contract partners will devote to our
research and development programs, product candidates or potential product candidates, and we
cannot guarantee that these parties will fulfill their obligations to us under these arrangements
in a timely fashion. We may not be able to readily terminate any such agreements with contract
partners even if such contract partners do not fulfill their obligations to us.
We are dependent on technologies we license, and if we lose the right to license such technologies
or we fail to license new technologies in the future, our ability to develop new products would be
harmed.
We currently are dependent on licenses from third parties for our key technologies relating to
fundamental RNAi technologies. Our current licenses impose, and any future licenses we enter into
are likely to impose, various development, funding, royalty, diligence, sublicensing, insurance and
other obligations on us. If our license with respect to any of these technologies is terminated for
any reason, the development of the products contemplated by the licenses would be delayed, or
suspended altogether, while we seek to license similar technology or develop new non-infringing
technology. The costs of obtaining new licenses are high, and many patents in the RNAi field have
already been exclusively licensed to third parties, including our competitors. If any of our
existing licenses are terminated, the development of the products contemplated by the licenses
could be delayed or terminated and we may not be able to negotiate additional licenses on
acceptable terms, if at all, which would have a material adverse effect on our business.
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 currently manufacture limited quantities of our product candidates for our research
activities at our facility, and we have no manufacturing supply arrangements for any of our product
candidates. 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
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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 by contract manufacturers
offering research grade, Good Laboratory grade and Good Manufacturing Practices grade materials for
preclinical studies (e.g. toxicology studies) and for clinical use. We anticipate the chemistry,
manufacturing and controls for each 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.
Any drug candidates we develop may fail in development or be delayed or may not be commercially
viable.
Before obtaining regulatory approval for the sale of any drug candidate, we must conduct, at
our own expense, extensive pre-clinical tests and clinical trials to demonstrate the safety and
efficacy in humans of our drug candidates. However, we are required to do extensive testing in
animal models with our product candidates before we can be approved by the FDA to initiate clinical
trials in humans. Furthermore, we cannot be sure that our product candidates will be safely
tolerated by humans or be efficacious. All of our products in development must be approved by the
FDA or similar foreign governmental agencies before they can be marketed. The process for obtaining
FDA approval is both time-consuming and costly, with no certainty of a successful outcome. This
process typically includes the conduct of extensive preclinical and clinical testing, which may
take longer or cost more than we anticipate, and may prove unsuccessful due to numerous factors. A
failure of one or more of our pre-clinical studies or clinical trials can occur at any stage of
testing. Product candidates that may appear to be promising at early stages of development may not
successfully reach the market for a number of reasons. The results of pre-clinical and initial
clinical testing of these products may not necessarily indicate the results that will be obtained
from later or more extensive testing. Companies in the pharmaceutical and biotechnology industries
have suffered significant setbacks in advanced clinical trials, even after obtaining promising
results in earlier trials.
We, the FDA or other applicable regulatory authorities, or an institutional review board
(IRB), an independent committee under the oversight of the United States Department of Health and
Human Services (HHS), which has been formally registered with HHS and functions to approve,
monitor and review biomedical and behavioral research involving humans, may suspend clinical trials
of a drug candidate at any time for various reasons, including if we or they believe the subjects
or patients participating in such trials are being exposed to unacceptable health risks. Among
other reasons, adverse side effects of a drug candidate on subjects or patients in a clinical trial
could result in the FDA or other regulatory authorities suspending or terminating the trial and
refusing to approve a particular drug candidate for any or all indications of use.
Clinical trials of a new drug candidate require the enrollment of a sufficient number of
patients, including patients who are suffering from the disease the drug candidate is intended to
treat and who meet other eligibility criteria. Rates of patient enrollment are affected by many
factors, and delays in patient enrollment can result in increased costs and longer development
times.
Clinical trials also require the review and oversight of IRBs, which approve and continually
review clinical investigations and protect the rights and welfare of human subjects. An inability
or delay in obtaining IRB approval could prevent or delay the initiation and completion of clinical
trials, and the FDA may decide not to consider any data or information derived from a clinical
investigation not subject to initial and continuing IRB review and approval.
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Numerous factors could affect the timing, cost or outcome of our drug development efforts,
including the following:
| Delays in filing initial drug applications, | ||
| Difficulty in securing centers to conduct trials, | ||
| Conditions imposed on us by the FDA or comparable foreign authorities regarding the scope or design of our clinical trials, | ||
| Problems in engaging IRBs to oversee trials or problems in obtaining or maintaining IRB approval of studies, | ||
| Difficulty in enrolling patients in conformity with required protocols or projected timelines, | ||
| Third party contractors failing to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, | ||
| Our drug candidates having very different chemical and pharmacological properties in humans than in laboratory testing and interacting with human biological systems in unforeseen, ineffective or harmful ways, | ||
| The need to suspend or terminate our clinical trials if the participants are being exposed to unacceptable health risks, | ||
| Insufficient or inadequate supply or quality of our drug candidates or other necessary materials necessary to conduct our clinical trials, | ||
| Effects of our drug candidates not being the desired effects or including undesirable side effects or the drug candidates having other unexpected characteristics, | ||
| The cost of our clinical trials may be greater than we anticipate, | ||
| Negative or inconclusive results from our clinical trials or the clinical trials of others for drug candidates similar to our own or inability to generate statistically significant data confirming the efficacy of the product being tested, | ||
| Changes in the FDAs requirements for our testing during the course of that testing, | ||
| Modification of the drug during testing, | ||
| Reallocation of our limited financial and other resources to other clinical programs, and | ||
| Adverse results obtained by other companies developing RNAi drugs. |
The substances we are intending to develop may represent a new class of drug, and the FDA has
not yet established any definitive policies, practices or guidelines in relation to these drugs.
While we expect any product candidates that we develop will be regulated as a new drug under the
Federal Food, Drug, and Cosmetic Act, the FDA could decide to regulate them or other products we
may develop as biologics under the Public Health Service Act. The lack of policies, practices or
guidelines may hinder or slow review by the FDA of any regulatory filings that we may submit.
Moreover, the FDA may respond to these submissions by defining requirements that we may not have
anticipated.
It is possible that none of the product candidates that we develop will obtain the appropriate
regulatory approvals necessary for us to begin selling them or that any regulatory approval to
market a product may be subject to limitations on the indicated uses for which we may market the
product. The time required to obtain FDA and other approvals is unpredictable but often can take
years following the commencement of clinical trials, depending upon the complexity of the drug
candidate. Any analysis we perform of data from clinical activities is subject to confirmation and
interpretation by regulatory authorities, which could delay, limit or prevent regulatory approval.
Any delay or failure in obtaining required approvals could have a material adverse effect on our
ability to generate revenue from the particular drug candidate.
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We are also subject to numerous foreign regulatory requirements governing the conduct of
clinical trials, manufacturing and marketing authorization, pricing and third-party reimbursement.
The foreign regulatory approval process includes all of the risks associated with FDA approval
described above as well as risks attributable to the satisfaction of local regulations in foreign
jurisdictions. Approval by the FDA does not assure approval by regulatory authorities outside of
the United States.
The FDA approval process may be delayed for any drugs we develop that require the use of
specialized drug delivery devices or vehicles.
Some drug candidates that we develop may need to be administered using specialized vehicles
that deliver RNAi therapeutics directly to diseased parts of the body. For example, we may use an
implantable pump to deliver certain potential drug candidates to the nervous system. The drug
delivery vehicles that we expect to deliver our drug candidates have not been approved by the FDA
or other regulatory agencies. In addition, the FDA may regulate the product as a combination
product of a drug and a device or require additional approvals or clearances for the modified
delivery.
Further, to the extent the specialized delivery vehicle is owned by another company, we would
need that companys cooperation to implement the necessary changes to the vehicle, or its labeling,
and to obtain any additional approvals or clearances. Any delays in finding suitable drug delivery
vehicles to administer RNAi therapeutics directly to diseased parts of the body could negatively
affect our ability to successfully develop our RNAi therapeutics.
If we are not successful in developing pre-clinical product candidates, we will not be able to
commence clinical trials in humans or obtain approval for our product candidates.
We are in the new drug discovery phase and we have not yet identified any lead compounds for
therapeutic development. RNA interference is a relatively new scientific field, and the
technologies are still in the early stage of development. We have no compounds in pre-clinical
toxicology studies, and we may not be able to advance any product candidate through the
pre-clinical stage into clinical trials. Additionally, our development efforts may never result in
the identification of a pre-clinical candidate which we are able to successfully develop into a
drug. Even if we are able to designate a lead candidate, we may not be able to identify data that
would support entering such a candidate into clinical trials. Furthermore, even if we successfully
enter into clinical studies, the results from pre- clinical testing of a drug candidate may not
predict the results that will be obtained on human clinical trials.
Even if we obtain regulatory approvals, our marketed drugs will be subject to ongoing regulatory
review. If we fail to comply with continuing U.S. and foreign regulations, we could lose our
approvals to market drugs and our business would be materially adversely affected.
Following any initial regulatory approval of any drugs we may develop, we will also be subject
to continuing regulatory review, including the review of adverse drug experiences and clinical
results that are reported after our drug products are made available to patients. This would
include results from any post marketing tests or vigilance required as a condition of approval. The
manufacturer and manufacturing facilities we use to make any of our drug candidates will also be
subject to periodic review and inspection by the FDA. The discovery of any new or previously
unknown problems with the product, manufacturer or facility may result in restrictions on the drug
or manufacturer or facility, including withdrawal of the drug from the market. Our product
promotion and advertising also will be subject to regulatory requirements and continuing regulatory
review. If we fail to comply with applicable continuing regulatory requirements, we may be subject
to fines, suspension or withdrawal of regulatory approval, product recalls and seizures, operating
restrictions and other adverse consequences.
Even if we receive regulatory approval to market our product candidates, our product candidates may
not be accepted commercially, which may prevent us from becoming profitable.
The product candidates that we are developing are based on new technologies and therapeutic
approaches. RNAi products may be more expensive to manufacture than traditional small molecule
drugs, which may make them more costly than competing small molecule drugs. Additionally, for
various applications, RNAi products are likely to require injection or implantation, and do not
readily cross the so-called blood brain barrier, which will make them
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less convenient to administer than drugs administered orally. Key participants in the
pharmaceutical marketplace, such as physicians, medical professionals working in large reference
laboratories, public health laboratories and hospitals, third- party payors and consumers, may not
accept products intended to improve therapeutic results based on RNAi technology. As a result, it
may be more difficult for us to convince the medical community and third-party payors to accept and
use our product, or to provide favorable reimbursement. And if medical professionals working with
large reference laboratories, public health laboratories and hospitals choose not to adopt and use
our RNAi technology, our products may not achieve broader market acceptance.
Other factors that we believe will materially affect market acceptance of our product candidates
include:
| The timing of our receipt of any marketing approvals, the terms of any approvals and the countries in which approvals are obtained, | ||
| The safety, efficacy and ease of administration of our product candidates, | ||
| The advantages of our product candidates over those of our competitors, | ||
| The willingness of patients to accept relatively new therapies, | ||
| The success of our physician education programs, | ||
| The availability of government and third-party payor reimbursement, | ||
| The pricing of our products, particularly as compared to alternative treatments, and | ||
| The availability of effective alternative treatments and the relative risks and/or benefits of the treatments. |
We may be unable to protect our intellectual property rights licensed from others parties, 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 Fire-Mello 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 third parties are claimed in a number of 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 and those that we own 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. Third parties may hold
or seek to obtain additional patents that could make it more difficult or impossible for us to
develop products based on RNAi technology without obtaining a license to such patents, which
licenses may not be available on attractive terms or at all.
In addition, others may challenge the patents or patent applications that we currently license
or may license in the future or that we own 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 license or that we own 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
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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 or patents
or patent application that we own.
We may need to license additional intellectual property rights from this third party or other
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 other third parties that may
be unavailable. There is no assurance that we will be able to acquire any additional intellectual
property rights on satisfactory terms, or at all. To the extent that we are required and are able
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.
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 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. These applications claim many different methods, compositions and
processes relating to the discovery, development, delivery and commercialization of RNAi
therapeutics. Because the field is so new, very few of these patent applications have been fully
processed by government patent offices around the world, and there is a great deal of uncertainty
about which patents will issue, when, to whom, and with what claims. It is likely that there will
be significant litigation and other proceedings, such as interference and opposition proceedings in
various patent offices, relating to patent rights in the RNAi field and that we may be a party to
such proceedings.
There may be patent or other intellectual property rights belonging to others that require us
to alter our products, pay licensing fees or cease certain activities.. If our products infringe
patent or other intellectual property rights of others, the owners of those rights could bring
legal actions against us claiming damages and seeking to enjoin manufacturing and marketing of the
affected products. If these legal actions are successful, in addition to any potential liability
for damages, we could be required to obtain a license in order to continue to manufacture or market
the affected products. We may not prevail in any action brought against us, and any license
required under any rights that we infringe may not be available on acceptable terms or at all.
Others may attempt to invalidate our intellectual property rights or those of our licensors. Even
if our rights, or those of our licensors, are not directly challenged, disputes among third parties
could lead to the weakening or invalidation of our intellectual property
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rights. Any attempt by third parties to circumvent or invalidate our intellectual property
rights could be costly to defend, require significant time and attention of our management and have
a material adverse effect on our business.
We are subject to potential liabilities from clinical testing and future product liability claims.
If any of our future products are alleged to be defective, they may expose us to claims for
personal injury by patients in clinical trials of our products or by patients using our
commercially marketed products. Even if the marketing of one or more of our products is approved by
the FDA, users may claim that such products caused unintended adverse effects. We will seek to
obtain clinical trial insurance for clinical trials that we conduct, as well as liability insurance
for any products that we market. There can be no assurance that we will be able to obtain insurance
in the amounts we seek, or at all. We anticipate that licensees who develop our products will carry
liability insurance covering the clinical testing and marketing of those products. There is no
assurance, however, that any insurance maintained by us or our licensees will prove adequate in the
event of a claim against us. Even if claims asserted against us are unsuccessful, they may divert
managements attention from our operations and we may have to incur substantial costs to defend
such claims.
Any drugs we develop may become subject to unfavorable pricing regulations, third-party
reimbursement practices or healthcare reform initiatives, which could have a material adverse
effect on our business.
We intend to sell our products primarily to hospitals which receive reimbursement for the
health care services they provide to their patients from third-party payors, such as Medicare,
Medicaid and other domestic and international government programs, private insurance plans and
managed care programs. Most third-party payors may deny reimbursement if they determine that a
medical product was not used in accordance with cost-effective treatment methods, as determined by
the third-party payor, or was used for an unapproved indication. Third-party payors also may refuse
to reimburse for experimental procedures and devices. Furthermore, because our programs are in the
early stages of development, we are unable at this time to determine their cost-effectiveness and
the level or method of reimbursement for them. Increasingly, the third-party payors who reimburse
patients are requiring that drug companies provide them with predetermined discounts from list
prices, and are challenging the prices charged for medical products. If the price we are able to
charge for any products we develop is inadequate in light of our development and other costs, our
profitability could be adversely effected.
We currently expect that any drugs we develop may need to be administered under the
supervision of a physician. Under currently applicable law, drugs that are not usually
self-administered may be eligible for coverage by the Medicare program if:
| They are incidental to a physicians services, | ||
| They are reasonable and necessary for the diagnosis or treatment of the illness or injury for which they are administered according to accepted standard of medical practice, | ||
| They are not excluded as immunizations, and | ||
| They have been approved by the FDA. |
There may be significant delays in obtaining insurance coverage for newly-approved drugs, and
insurance coverage may be more limited than the purpose for which the drug is approved by the FDA.
Moreover, eligibility for insurance coverage does not imply that any drug will be reimbursed in all
cases or at a rate that covers our costs, including research, development, manufacture, sale and
distribution. Interim payments for new drugs, if applicable, may also not be sufficient to cover
our costs and may not be made permanent. Reimbursement may be based on payments for other services
and may reflect budgetary constraints or imperfections in Medicare data. Net prices for drugs may
be reduced by mandatory discounts or rebates required by government health care programs or private
payors and by any future relaxation of laws that presently restrict imports of drugs from countries
where they may be sold at lower prices than in the United States. Third-party payors often rely
upon Medicare coverage policy and payment limitations in setting their own reimbursement rates. Our
inability to promptly obtain coverage and profitable reimbursement rates from both government-
funded and private payors for new drugs that we develop
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could have a material adverse effect on our operating results, our ability to raise capital
needed to develop products, and our overall financial condition.
Additionally, third-party payors are increasingly attempting to contain health care costs by
limiting both coverage and the level of reimbursement for medical products and services. Levels of
reimbursement may decrease in the future, and future legislation, regulation or reimbursement
policies of third-party payors may adversely affect the demand for and price levels of our
products. If our customers are not reimbursed for our products, they may reduce or discontinue
purchases of our products, which could have a material adverse effect on our business, financial
condition and results of operations.
Comprehensive health care reform legislation, which was recently adopted by Congress and was
subsequently signed into law, could adversely affect our business and financial condition. Among
other provisions, the legislation provides that a biosimilar product may be approved by the FDA
on the basis of analytical tests and certain clinical studies demonstrating that such product is
highly similar to an existing, approved product and that switching between an existing product and
the biosimilar product will not result in diminished safety or efficacy. This abbreviated
regulatory approval process may result in increased competition if we are able to bring a product
to market. The legislation also includes more stringent compliance programs for companies in
various sectors of the life sciences industry with which we may need to comply and enhanced
penalties for non-compliance with the new health care regulations. Complying with new regulations
may divert management resources, and inadvertent failure to comply with new regulations may result
in penalties being imposed on us.
Some states and localities have established drug importation programs for their citizens, and
federal drug import legislation has been introduced in Congress. The Medicare Prescription Drug
Plan legislation, which became law in December 2003, required the Secretary of Health and Human
Services to promulgate regulations for drug reimportation from Canada into the United States under
some circumstances, including when the drugs are sold at a lower price than in the United States.
The Secretary, however, retained the discretion not to implement a drug reimportation plan if he
finds that the benefits do not outweigh the costs, and has so far declined to approve a
reimportation plan. Proponents of drug reimportation may attempt to pass legislation that would
directly allow reimportation under certain circumstances. Legislation or regulations allowing the
reimportation of drugs, if enacted, could decrease the price we receive for any products that we
may develop and adversely affect our future revenues and prospects for profitability.
If we fail to attract, hire and retain qualified personnel, we may not be able to design, develop,
market or sell our products or successfully manage our business.
We are highly dependent on our named executive officers and Scientific Advisory Board (SAB)
members. The continued service of our named executive officers and SAB members is critical to our
success. We have entered into employment agreements with our named executive officers, all of which
can be terminated by such persons on short notice. The loss of any of our named executive officers
or SAB members, or our inability to identify, attract, retain and integrate additional qualified
key personnel, could make it difficult for us to manage our business successfully and achieve our
business objectives.
Competition for skilled research, product development, regulatory and technical personnel also
is intense, and we may not be able to recruit and retain the personnel we need. The loss of the
services of any key research, product development, regulatory, and technical personnel, or our
inability to hire new personnel with the requisite skills, could restrict our ability to develop
our product candidates.
We use biological and hazardous materials and if we do not comply with laws regulating the
protection of the environment and health and human safety, our business could be adversely
affected.
Our research and development activities involve the controlled use of potentially harmful
biological materials as well as hazardous materials, chemicals and various radioactive compounds.
We cannot completely eliminate the risk of accidental contamination or injury; we could be held
liable for any damages that result, and any liability could exceed our resources. We are subject to
federal, state and local laws and regulations governing the use, storage, handling and disposal of
these materials and specific waste products. We are also subject to numerous environmental, health
and workplace safety laws and regulations, including those governing laboratory procedures,
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exposure to blood-borne pathogens and the handling of biohazardous materials. The cost of
compliance with these laws and regulations could be significant and may adversely affect capital
expenditures to the extent we are required to procure expensive capital equipment to meet
regulatory requirements.
We are also subject to numerous environmental, health and workplace safety laws and
regulations, including those governing laboratory procedures, exposure to blood-borne pathogens and
the handling of biohazardous materials. We maintain workers compensation insurance to cover us
for costs and expenses we may incur due to injuries to our employees resulting from the use of
these materials. The limits of our workers compensation insurance are mandated by state law, and
our workers compensation liability is capped at these state-mandated limits. We do not maintain
insurance for environmental liability or toxic tort claims that may be asserted against us in
connection with our storage or disposal of biological, hazardous or radioactive materials.
Additional federal, state and local laws and regulations affecting our operations may be adopted in
the future. We may incur substantial costs to comply with, and substantial fines or penalties if we
violate any of these laws or regulations.
Risks Relating Our Financial Position and Capital Requirements
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 and cash equivalent should be sufficient to fund our
operations through at least the first half of 2011. 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. In addition, until its expiration on January 30, 2011, we also have
available to us the SEDA that we entered into on January 30, 2009. However, 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. 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 product candidates, | ||
| 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.
We expect to continue to incur significant research and development expenses, which may make it
difficult for us to attain profitability, and may lead to uncertainty about or as to our ability to
continue as a going concern.
Substantial funds were expended to develop our RNAi technologies, and additional substantial
funds will be required for further research and development, including pre-clinical testing and
clinical trials of any product
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candidates, and to manufacture and market any products that are approved for commercial sale.
Because the successful development of our products is uncertain, we are unable to precisely
estimate the actual funds we will require to develop and potentially commercialize them. In
addition, we may not be able to generate enough revenue, even if we are able to commercialize any
of our product candidates, to become profitable.
In the event that we are unable to achieve or sustain profitability or to secure additional
financing, we may not be able to meet our obligations as they come due, raising substantial doubts
as to our ability to continue as a going concern. Any such inability to continue as a going concern
may result in our common stock holders losing their entire investment. There is no guaranty that we
will become profitable or secure additional financing. Our financial statements contemplate that we
will continue as a going concern and do not contain any adjustments that might result if we were
unable to continue as a going concern. Changes in our operating plans, our existing and anticipated
working capital needs, the acceleration or modification of our expansion plans, increased expenses,
potential acquisitions or other events will all affect our ability to continue as a going concern.
Future financing may be obtained through, and future development efforts may be paid for by, the
issuance of debt or equity, which may have an adverse effect on our stockholders or may otherwise
adversely affect our business.
If we raise funds through the issuance of debt or equity, any debt securities or preferred
stock issued will have rights, preferences and privileges senior to those of holders of our common
stock in the event of a liquidation. In such event, there is a possibility that once all senior
claims are settled, there may be no assets remaining to pay out to the holders of common stock. In
addition, if we raise funds through the issuance of additional equity, whether through private
placements or additional public offerings, such an issuance would dilute your ownership in us.
The terms of debt securities may also impose restrictions on our operations, which may include
limiting our ability to incur additional indebtedness, to pay dividends on or repurchase our
capital stock, or to make certain acquisitions or investments. In addition, we may be subject to
covenants requiring us to satisfy certain financial tests and ratios, and our ability to satisfy
such covenants may be affected by events outside of our control.
You may have difficulty evaluating our business, because we have limited history and our historical
financial information may not be representative of our future results.
The historical financial information included in our annual report on Form 10-K for the year
ended December 31, 2009 does not necessarily reflect the financial condition, results of operations
or cash flows that we would have achieved as a separate company during the periods presented or
those that we will achieve in the future. Prior to the contribution of our RNAi assets from CytRx,
our RNAi research and development activities were conducted by CytRx as part of its broader
operations, rather than as an independent division or subsidiary, and were primarily conducted
through sponsored research arrangements rather than through internal activities. CytRx also
performed various corporate functions relating to our business, as discussed above. Our historical
financial information reflects allocations of indirect expenses from CytRx for these and similar
functions. We believe that these allocations are comparable to the expenses we would have incurred
had we operated as a separate company, although we may incur higher expenses as a separate company.
We have limited operating experience and may not be able to effectively operate.
We are a discovery-stage company with limited operating history. We will focus solely on
developing and, if we obtain regulatory approval for our product candidates, commercializing
therapeutic products based upon RNAi technologies, and there is no assurance that we will be able
to successfully implement our business plan. While our management collectively possesses
substantial business experience, there is no assurance that we will be able to manage our business
effectively, or that we will be able to identify, hire and retain any needed additional management
or scientific personnel to develop and implement our product development plans, obtain third-party
contracts or any needed financing, or achieve the other components of our business plan.
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The obligations associated with being an independent public company require significant resources
and management attention.
As a publicly traded company, we are subject to the reporting requirements of the U.S.
Securities Exchange Act of 1934, as amended (the Exchange Act), and the Sarbanes-Oxley Act of
2002. In addition, the Exchange Act requires that we file annual, quarterly and current reports.
Our failure to prepare and disclose this information in a timely manner could subject us to
penalties under federal securities laws, expose us to lawsuits and restrict our ability to access
financing. The Sarbanes-Oxley Act requires that we, among other things, establish and maintain
effective internal controls and procedures for financial reporting. From time to time we evaluate
our existing internal controls in light of the standards adopted by the Public Company Accounting
Oversight Board. It is possible that we or our independent registered public accounting firm may
identify significant deficiencies or material weaknesses in our internal control over financial
reporting in the future. Any failure or difficulties in implementing and maintaining these controls
could cause us to fail to meet the periodic reporting obligations or result in material
misstatements in our financial statements.
Section 404 of the Sarbanes-Oxley Act requires annual management assessments of the
effectiveness of our internal control over financial reporting. Our failure to satisfy the
requirements of Section 404 on a timely basis could result in the loss of investor confidence in
the reliability of our financial statements, which in turn could have a material adverse effect on
our business and our common stock.
Risks Related to Ownership of Our Common Stock
The market price and trading volume of our common stock may be volatile
The market price of our common stock could fluctuate significantly for many reasons, including
the following factors:
| Announcements of regulatory developments or technological innovations by us or our competitors, | ||
| Changes in our relationship with our licensors and other strategic partners, | ||
| Changes in our ownership or other relationships with CytRx, | ||
| Our quarterly operating results, | ||
| Developments in patent or other technology ownership rights, | ||
| Public concern regarding the safety of our products, | ||
| Additional funds may not be available on terms that are favorable to us and, in the case of equity financings, may result in dilution to our stock holders, | ||
| Government regulation of drug pricing, and | ||
| General changes in the economy, the financial markets or the pharmaceutical or biotechnology industries. |
In addition, factors beyond our control may also have an impact on the price of our stock. For
example, to the extent that other large companies within our industry experience declines in their
stock price, our stock price may decline as well. In addition, when the market price of a companys
common stock drops significantly, stockholders often institute securities class action lawsuits
against the company. A lawsuit against us could cause us to incur substantial costs and could
divert the time and attention of our management and other resources.
Sales of our shares by CytRx could adversely affect our stock price.
As of August 9, 2010, CytRx owned 3,093,881 shares of our common stock, or approximately 16.8%
of our outstanding shares. The availability of our shares held by CytRx for public resale on the
open market, as well as any actual sales of these shares, could adversely affect the market price
of our shares.
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We have granted CytRx preemptive rights to acquire shares that we may sell in the future, which may
impair our ability to raise funds.
Under an agreement between us, CytRx and our founding stockholders, with some exceptions,
CytRx has preemptive rights to acquire a portion of any new securities sold or issued by us so as
to maintain its percentage ownership of us at the time of any such sale and issuance, which is
currently approximately 16.8% of our outstanding shares. The exercise by CytRx of its preemptive
rights may impair our ability to raise funds, or adversely affect the terms on which we are able to
raise funds, as we may not be able to offer to new investors the quantity of our stock that they
may desire to purchase.
CytRxs ownership of our common stock could delay or prevent a change in corporate control.
CytRx owns approximately 16.8% of our common stock, and has preemptive rights, as described
above, to maintain its percentage ownership. CytRx has agreed with UMMS, us and our other founding
stockholders to vote its shares of our common stock so that a majority of the members of our board
of directors are not affiliated with CytRx. However, by virtue of its stock ownership, CytRx may be
able to significantly influence the outcome of matters required to be submitted to a vote of our
stockholders, including any proposed amendments to our certificate of incorporation and approval of
mergers and other significant corporate transactions. This concentration of ownership may adversely
affect the market price of our common stock by:
| Delaying, deferring or preventing a change in control of our company, | ||
| Impeding a merger, consolidation, takeover or other business combination involving our company, or | ||
| Discouraging a potential acquirer from making a tender offer or otherwise attempting to obtain control of our company. |
CytRx could unilaterally effect a change of control of our company by selling or disposing of our
shares owned by it.
If CytRx were to sell or otherwise dispose of all or a significant portion of our shares owned
by it to a single buyer or group of affiliated buyers, it could effect a potential change of
control of our company without the advice or participation by our board of directors or other
stockholders, since transferees of the shares owned by CytRx will not be bound by CytRxs
agreements with UMMS, us and our other founding stockholders with respect to voting such shares.
Anti-takeover provisions of our certificate of incorporation and by-laws and provisions of Delaware
law could delay or prevent a change of control that you may favor.
Anti-takeover provisions of our certificate of incorporation and by-laws and provisions of
Delaware law may discourage, delay or prevent a merger or other change of control that stockholders
may consider favorable, or may impede the ability of the holders of our common stock to change our
management. These provisions of our certificate of incorporation and by-laws, among other things:
| Divide our board of directors into three classes, with members of each class to be elected for staggered three-year terms, | ||
| Limit the right of stockholders to remove directors, | ||
| Regulate how stockholders may present proposals or nominate directors for election at annual meetings of stockholders, and | ||
| Authorize our board of directors to issue preferred stock in one or more series, without stockholder approval. |
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In addition, Section 203 of the Delaware General Corporation Law provides that, subject to
limited exceptions, persons that acquire, or are affiliated with a person that acquires, more than
15% of the outstanding voting stock of a Delaware corporation such as our company shall not engage
in any business combination with that corporation, including by merger, consolidation or
acquisitions of additional shares for a three-year period following the date on which that person
or its affiliate crosses the 15% stock ownership threshold. Section 203 could operate to delay or
prevent a change of control of our company.
We may acquire other businesses or form joint ventures that may be unsuccessful and could adversely
dilute your ownership of our company.
As part of our business strategy, we may pursue future acquisitions of other complementary
businesses and technology licensing arrangements. We also may pursue strategic alliances. We have
no experience with respect to acquiring other companies and limited experience with respect to the
formation of collaborations, strategic alliances and joint ventures. If we were to make any
acquisitions, we may not be able to integrate these acquisitions successfully into our existing
business and we could assume unknown or contingent liabilities. We also could experience adverse
effects on our reported results of operations from acquisition related charges, amortization of
acquired technology and other intangibles and impairment charges relating to write-offs of goodwill
and other intangible assets from time to time following the acquisition. Integration of an acquired
company also may require management resources that otherwise would be available for ongoing
development of our existing business. We may not identify or complete these transactions in a
timely manner, on a cost-effective basis, or at all, and we may not realize the anticipated
benefits of any acquisition, technology license or strategic alliance.
To finance acquisitions, we may choose to issue shares of our common stock as consideration,
which would dilute your ownership interest in us. Alternatively, it may be necessary for us to
raise additional funds through public or private financings. Additional funds may not be available
on terms that are favorable to us and, in the case of equity financings, may result in dilution to
our stockholders. Any future acquisitions by us also could result in large and immediate
write-offs, the incurrence of contingent liabilities or amortization of expenses related to
acquired intangible assets, any of which could harm our operating results.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None
ITEM 4. RESERVED
ITEM 5. OTHER INFORMATION
None
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ITEM 6. EXHIBIT
EXHIBIT INDEX
Exhibit | ||
Number | Description | |
3.1
|
Form of Amended and Restated Certificate of Incorporation of RXi Pharmaceuticals Corporation(1) | |
3.2
|
Form of Amended and Restated By-laws of RXi Pharmaceuticals Corporation(1) | |
31.1
|
Sarbanes-Oxley Act Section 302 Certification of Noah D. Beerman | |
31.2
|
Sarbanes-Oxley Act Section 302 Certification of Amy B. Tata | |
32.1
|
Sarbanes-Oxley Act Section 906 Certification of Noah D. Beerman and Amy B. Tata |
(1) | Previously filed as an Exhibit to the Companys Registration Statement on Form S-1 filed on October 30, 2007 (File No. 333-147009) and incorporated by reference herein |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly
caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
RXi PHARMACEUTICALS CORPORATION (Registrant) |
||||
By: | /s/ Noah D. Beerman | |||
Noah D. Beerman | ||||
President and Chief Executive Officer (Principal Executive Officer) |
||||
By: | /s/ Amy B. Tata | |||
Amy B. Tata | ||||
Principal Accounting Officer and Controller (Principal Accounting Officer) Date: August 16, 2010 |
||||
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