SELLAS Life Sciences Group, Inc. - Quarter Report: 2011 September (Form 10-Q)
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)
þ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2011
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
Galena Biopharma, Inc.
(Exact name of registrant as specified in its charter)
Delaware (State of incorporation) |
20-8099512 (I.R.S. Employer Identification No.) |
310 N. State Street, Suite 208, Lake Oswego, OR 97034
(Address of principal executive office) (Zip code)
(Address of principal executive office) (Zip code)
Registrants telephone number: (855) 855-4253
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 þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer or a smaller reporting company. See the definitions of large accelerated
filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
(Check one):
Large accelerated filer o | Accelerated filer o | Non-accelerated filer o | Smaller reporting company þ | |||
(Do not check if a smaller reporting company) |
Indicate by checkmark whether the Registrant is a shell company (as defined in Rule 12b-2 of
the Exchange Act).
Yes o No þ
As of
November 10, 2011, Galena Biopharma, Inc. had 42,985,453 shares of common stock, $0.0001 par
value, outstanding, exclusive of treasury shares.
Galena Biopharma, Inc.
FORM 10-Q QUARTER ENDED September 30, 2011
FORM 10-Q QUARTER ENDED September 30, 2011
INDEX
Page | ||||||||||||
Part No. | Item No. | Description | No. | |||||||||
I | ||||||||||||
1 | 3 | |||||||||||
3 | ||||||||||||
4 | ||||||||||||
5 | ||||||||||||
8 | ||||||||||||
2 | 20 | |||||||||||
4 | 23 | |||||||||||
II | ||||||||||||
1 | 24 | |||||||||||
1A | 24 | |||||||||||
2 | 25 | |||||||||||
3 | 25 | |||||||||||
4 | 25 | |||||||||||
5 | 25 | |||||||||||
6 | 25 | |||||||||||
Index to Exhibits | 25 | |||||||||||
Signatures | 26 | |||||||||||
EX-10.1 | ||||||||||||
EX-10.2 | ||||||||||||
EX-10.3 | ||||||||||||
EX-31.1 | ||||||||||||
EX-32.1 | ||||||||||||
EX-101 INSTANCE DOCUMENT | ||||||||||||
EX-101 SCHEMA DOCUMENT | ||||||||||||
EX-101 CALCULATION LINKBASE DOCUMENT | ||||||||||||
EX-101 LABELS LINKBASE DOCUMENT | ||||||||||||
EX-101 PRESENTATION LINKBASE DOCUMENT |
2
Table of Contents
PART I
ITEM 1. FINANCIAL STATEMENTS
Galena Biopharma, Inc.
(A Development Stage Company)
(A Development Stage Company)
CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except share and per share data)
(Unaudited)
September 30, | December 31, | |||||||
2011 | 2010 | |||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 15,693 | $ | 6,891 | ||||
Prepaid expenses and other current assets |
494 | 150 | ||||||
Total current assets |
16,187 | 7,041 | ||||||
Equipment and furnishings, net |
430 | 419 | ||||||
In-process research & development |
12,864 | | ||||||
Goodwill |
845 | | ||||||
Deposits |
3 | 16 | ||||||
Total assets |
$ | 30,329 | $ | 7,476 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 1,462 | $ | 724 | ||||
Accrued expenses and other current liabilities |
1,699 | 1,113 | ||||||
Convertible notes payable |
500 | | ||||||
Deferred revenue |
877 | | ||||||
Current maturities of capital lease obligations |
65 | 51 | ||||||
Fair value
of warrants potentially settleable in cash (Note 8) |
15,226 | 3,138 | ||||||
Current contingent purchase price consideration |
1,632 | | ||||||
Total current liabilities |
21,461 | 5,026 | ||||||
Capital lease obligations, net of current maturities |
14 | 20 | ||||||
Contingent purchase price consideration, net of current portion |
4,145 | | ||||||
Total liabilities |
25,620 | 5,046 | ||||||
Commitments
and contingencies (Note 7) |
||||||||
Stockholders equity: |
||||||||
Preferred stock, $0.0001 par value; 5,000,000 shares
authorized; no shares issued and outstanding |
| | ||||||
Common
stock, $0.0001 par value; 125,000,000 shares authorized and
43,660,453 shares issued and 42,985,453 shares outstanding and 50,000,000 shares authorized and
19,047,759 shares issued and 18,372,759 outstanding at
September 30, 2011 and December 31, 2010, respectively |
4 | 2 | ||||||
Additional paid-in capital |
77,371 | 62,020 | ||||||
Deficit accumulated during the developmental stage |
(68,817 | ) | (55,743 | ) | ||||
Less treasury shares at cost, 675,000 shares |
(3,849 | ) | (3,849 | ) | ||||
Total stockholders equity |
4,709 | 2,430 | ||||||
Total liabilities and stockholders equity |
$ | 30,329 | $ | 7,476 | ||||
The accompanying notes are an integral part of these financial statements.
3
Table of Contents
Galena Biopharma, Inc.
(A Development Stage Company)
(A Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF EXPENSES
(Amounts in thousands, except share and per share data)
(Unaudited)
Period from | ||||||||||||||||||||
January 1, | ||||||||||||||||||||
2003 (Date of | ||||||||||||||||||||
For the Three | For the Three | For the Nine | For the Nine | Inception) to | ||||||||||||||||
Months Ended | Months Ended | Months Ended | Months Ended | September | ||||||||||||||||
September 30, | September 30, | September 30, | September 30, | 30, | ||||||||||||||||
2011 | 2010 | 2011 | 2010 | 2011 | ||||||||||||||||
Expenses: |
||||||||||||||||||||
Research and development expense |
$ | 2,618 | $ | 1,606 | $ | 7,069 | $ | 4,589 | $ | 33,748 | ||||||||||
Research and development
employee stock based
compensation expense |
349 | 274 | 807 | 814 | 3,214 | |||||||||||||||
Research and development
non-employee stock based
compensation expense |
35 | 56 | (41 | ) | 723 | 6,022 | ||||||||||||||
Fair value of common stock
issued in exchange for
licensing rights |
| | | | 3,954 | |||||||||||||||
Total research and
development expenses |
3,002 | 1,936 | 7,835 | 6,126 | 46,938 | |||||||||||||||
General and administrative |
1,447 | 1,126 | 4,978 | 4,228 | 26,088 | |||||||||||||||
General and administrative
employee stock based
compensation |
608 | 503 | 2,035 | 1,921 | 9,420 | |||||||||||||||
Common stock warrants issued
for general and administrative
expenses |
19 | 154 | 106 | 654 | 2,400 | |||||||||||||||
Fair value of common stock
issued in exchange for general
and administrative expenses |
| | 23 | | 304 | |||||||||||||||
Total general and
administrative expenses |
2,074 | 1,783 | 7,142 | 6,803 | 38,212 | |||||||||||||||
Operating loss |
(5,076 | ) | (3,719 | ) | (14,977 | ) | (12,929 | ) | (85,150 | ) | ||||||||||
Interest income (expense) |
(2 | ) | 3 | (6 | ) | 5 | 622 | |||||||||||||
Other income (expense) (Note 8) |
(397 | ) | (419 | ) | 1,909 | 2,762 | 5,670 | |||||||||||||
Net loss |
$ | (5,475 | ) | $ | (4,135 | ) | $ | (13,074 | ) | $ | (10,162 | ) | $ | (78,858 | ) | |||||
Net loss per common share: |
||||||||||||||||||||
Basic and diluted loss per share |
$ | (0.13 | ) | $ | (0.23 | ) | $ | (0.39 | ) | $ | (0.57 | ) | N/A | |||||||
Weighted average common shares
outstanding: |
||||||||||||||||||||
Basic and diluted |
41,970,481 | 18,372,759 | 33,697,704 | 17,717,610 | N/A | |||||||||||||||
The accompanying notes are an integral part of these financial statements.
4
Table of Contents
Galena Biopharma, Inc.
(A Development Stage Company)
(A Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Amounts in thousands)
(Unaudited)
Period from | ||||||||||||
January 1, | ||||||||||||
2003 | ||||||||||||
(Date of | ||||||||||||
For the Nine | For the Nine | Inception) | ||||||||||
Months Ended | Months Ended | Through | ||||||||||
September 30, | September 30, | September 30, | ||||||||||
2011 | 2010 | 2011 | ||||||||||
Cash flows from operating activities: |
||||||||||||
Net loss |
$ | (13,074 | ) | $ | (10,162 | ) | $ | (78,858 | ) | |||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||||||
Depreciation and amortization expense |
126 | 127 | 627 | |||||||||
Loss on disposal of equipment |
7 | | 19 | |||||||||
Non-cash rent expense |
| | 29 | |||||||||
Accretion and receipt of bond discount |
| (6 | ) | 35 | ||||||||
Non-cash share-based compensation |
2,801 | 3,458 | 18,658 | |||||||||
Loss on exchange of equity instruments |
900 | | 900 | |||||||||
Fair value of shares mandatorily redeemable for cash upon exercise of
warrants |
| | (785 | ) | ||||||||
Fair value of common stock warrants issued in exchange for services |
106 | 654 | 2,400 | |||||||||
Fair value of common stock issued in exchange for services |
23 | | 304 | |||||||||
Change in fair value of common stock warrants issued in connection
with various equity financings |
(1,942 | ) | (2,762 | ) | (4,133 | ) | ||||||
Fair value of common stock issued in exchange for licensing rights |
| | 3,954 | |||||||||
Change in fair value of contingent purchase consideration |
(683 | ) | | (683 | ) | |||||||
Changes in assets and liabilities: |
||||||||||||
Prepaid expenses |
(317 | ) | (214 | ) | (467 | ) | ||||||
Accounts payable |
(193 | ) | 211 | 531 | ||||||||
Due to former parent |
| | (207 | ) | ||||||||
Deferred revenue |
877 | | 877 | |||||||||
Accrued expenses and other current liabilities |
870 | 306 | 2,190 | |||||||||
Net cash used in operating activities |
(10,499 | ) | (8,388 | ) | (54,609 | ) | ||||||
Cash flows from investing activities: |
||||||||||||
Cash received in acquisition |
168 | | 168 | |||||||||
Purchase of short-term investments |
| (5,990 | ) | (37,532 | ) | |||||||
Maturities of short-term investments |
| | 37,497 | |||||||||
Cash paid for purchase of equipment and furnishings |
(53 | ) | (65 | ) | (739 | ) | ||||||
Disposal of equipment and furnishings |
| | (1 | ) | ||||||||
Cash refunded (paid) for lease deposit |
| | (45 | ) | ||||||||
5
Table of Contents
Period from | ||||||||||||
January 1, | ||||||||||||
2003 | ||||||||||||
(Date of | ||||||||||||
For the Nine | For the Nine | Inception) | ||||||||||
Months Ended | Months Ended | Through | ||||||||||
September 30, | September 30, | September 30, | ||||||||||
2011 | 2010 | 2011 | ||||||||||
Net cash provided by (used in) investing activities |
115 | (6,055 | ) | (652 | ) | |||||||
Cash flows from financing activities: |
||||||||||||
Net proceeds from issuance of common stock |
18,609 | 15,235 | 64,976 | |||||||||
Cash paid for repurchase of common stock |
| (3,849 | ) | (3,849 | ) | |||||||
Net proceeds from exercise of common stock options |
| 255 | 610 | |||||||||
Net proceeds from exercise of common stock warrants |
150 | | 150 | |||||||||
Net proceeds
from issuance of convertible notes payable |
500 | | 500 | |||||||||
Repayments of capital lease obligations |
(73 | ) | (46 | ) | (199 | ) | ||||||
Cash advances from former parent company, net |
| | 8,766 | |||||||||
Net cash provided by financing activities |
19,186 | 11,595 | 70,954 | |||||||||
Net increase (decrease) in cash and cash equivalents |
8,802 | (2,848 | ) | 15,693 | ||||||||
Cash and cash equivalents at the beginning of period |
6,891 | 5,684 | | |||||||||
Cash and cash equivalents at end of period |
$ | 15,693 | $ | 2,836 | $ | 15,693 | ||||||
Supplemental disclosure of cash flow information: |
||||||||||||
Cash received during the period for interest |
$ | 2 | $ | 1 | $ | 726 | ||||||
Cash paid during the period for interest |
$ | | $ | | $ | 7 | ||||||
6
Table of Contents
Period From | ||||||||||||
January 1, | ||||||||||||
For the | For the | 2003 | ||||||||||
Nine | Nine | (Date of | ||||||||||
Months | Months | Inception) | ||||||||||
Ended | Ended | through | ||||||||||
September30, | September30, | September 30, | ||||||||||
2011 | 2010 | 2011 | ||||||||||
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 |
$ | 13,232 | $ | 2,466 | $ | 18,561 | ||||||
Fair value of shares mandatorily redeemable for cash upon the exercise of
warrants |
$ | | $ | 785 | $ | 785 | ||||||
Fair value of stock options modified |
$ | | $ | | $ | | ||||||
Allocation of management expenses |
$ | | $ | | $ | 551 | ||||||
Equipment and furnishings exchanged for common stock |
$ | | $ | | $ | 48 | ||||||
Equipment and furnishings acquired through capital lease |
$ | 80 | $ | 53 | $ | 277 | ||||||
Value of restricted stock units and common stock issued in lieu of cash bonuses |
$ | 427 | $ | 254 | $ | 681 | ||||||
Non-cash lease deposit |
$ | | $ | | $ | 50 | ||||||
Apthera Acquisition: |
||||||||||||
Fair value of shares issued to acquire Apthera |
$ | 6,367 | $ | | $ | 6,367 | ||||||
Fair value of contingent purchase price consideration in connection
with Apthera acquisition |
$ | 6,460 | $ | | $ | 6,460 | ||||||
Net assets acquired excluding cash of $168 |
$ | 12,827 | $ | | $ | 12,827 | ||||||
The accompanying notes are an integral part of these financial statements.
7
Table of Contents
Galena Biopharma, Inc.
(A Development Stage Company)
(A Development Stage Company)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
1. Description of Business and Basis of Presentation
Galena Biopharma, Inc. (NASDAQ: GALE) is a biotechnology company focused on discovering,
developing and commercializing innovative therapies addressing major unmet medical needs using
targeted biotherapeutics. Galena is pursuing the development of novel cancer therapeutics using
peptide-based immunotherapy products, including our main product candidate, NeuVax (E75), for the
treatment of various cancers.
On September 26, 2011, the name of the company was changed from RXi Pharmaceuticals Corporation
to Galena Biopharma, Inc. ( Galena ) in connection with our planned separation into two
companies: (i) Galena, which will operate as a late-stage oncology drug development company; and
(ii) RXi Pharmaceuticals Corporation (RXi), which is a newly formed subsidiary of Galena that
will continue to develop novel RNAi-based therapies utilizing our
historical RNAi assets as described in Note 3.
Unless the context otherwise indicates, references in these Notes to the company, we, us or
our prior to the proposed separation, or spin-off, of RXi from Galena collectively refer to
Galena, RXi, and our other wholly owned subsidiary, Apthera, Inc. (Apthera).
Our new RXi subsidiary was formed by Galena in agreement with two institutional investors. As
described in more detail in Note 3, on September 24, 2011, we contributed to RXi
substantially all of our RNAi-related technologies and assets and entered into a number of
agreements relating to RXis ongoing business and operations. RXi will focus on developing and
commercializing therapeutic products based on RNAi technologies for the treatment of human
diseases, including its lead anti-scarring and anti-fibrosis product candidate, RXI-109, with
initial financing provided by us and the institutional investors. In these agreements, we have
committed, among other things, to undertake to distribute to our stockholders a portion of the RXi
common stock held by Galena in order to accomplish the spin-off of RXi.
To date, RXis activities have consisted of completing its organizational activities,
acquiring our RNAi-related assets and entering
into the agreements described in Note 3.
The Company has not generated any revenues since inception nor are any revenues expected for
the foreseeable future. The Company expects to incur significant operating losses for the
foreseeable future while the Company advances its future product candidates from discovery through
pre-clinical studies and clinical trials and seek regulatory approval and potential
commercialization, even if the Company is collaborating with pharmaceutical and larger
biotechnology companies. In addition to these increasing research and development expenses, the
Company expects general and administrative costs to increase as the Company recruits additional
management and administrative personnel. The Company will need to generate significant revenues to
achieve profitability and may never do so.
The Company believes that our existing cash and cash equivalents should be sufficient to fund
our operations for the next twelve months. In the future, the Company will be dependent on
obtaining funding from third parties such as proceeds from the sale of equity, funded research and
development payments and payments under partnership and collaborative agreements, in order to
maintain our operations and meet our obligations to licensors. There is no guarantee that 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, the Companys
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, 2010 included in the Companys Annual Report on Form 10-K filed with the SEC on April
15, 2011 and as amended on May 2, 2011. 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 nine months ended September 30, 2011 and 2010 and three months ended September 30,
2011 and 2010, as well as the cumulative financial information for the period from January 1, 2003
(date of inception) through September 30, 2011 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, 2010. 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.
8
Table of Contents
Uses of estimates in preparation of financial statements
The preparation of financial statements in accordance with U.S. GAAP requires management to
make estimates and assumptions that affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the date of the financial statements and the
reported amounts of revenues and expenses during the reporting period. Actual results could differ
from these estimates.
Derivative Financial Instruments
During the normal course of business, from time to time the Company issues warrants and
options to vendors as consideration to perform services. It may also issue warrants as part of a
debt or equity financing. The Company does not enter into any derivative contracts for speculative
purposes. 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. See Note 10.
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.
Deferred Revenue
Deferred
revenue consists of advance payments received under government
grants. The Company will relieve the deferred revenue when the
obligations under the grants are fulfilled.
Principles of Consolidation
The consolidated financial statements include the accounts of Galena and its
wholly owned subsidiaries. All material intercompany accounts have
been eliminated in consolidation.
2. Apthera Acquisition
On April 13, 2011, the Company completed its acquisition of Apthera, Inc., a Delaware
corporation (Apthera), under an Agreement and Plan of Merger entered into on March 31, 2011.
Subject to the terms and conditions of the merger agreement, the Companys wholly owned subsidiary
formed for this purpose was merged with and into Apthera, with Apthera surviving as a wholly-owned
subsidiary of the Company. Under the merger agreement, the Company issued to Aptheras stockholders
approximately 5.0 million shares of common stock of the Company
(the Aggregate Stock Consideration) and agreed to make future
contingent payments of up to $32 million based on the achievement of certain development and
commercial milestones relating to the Companys NeuVax product candidate. The contingent
consideration is payable, at the election of the Company, in either cash or additional shares of
common stock, provided that the Company may not issue any shares in satisfaction of any contingent
consideration unless it has first obtained approval of its stockholders in accordance with Rule
5635(a) of the NASDAQ Marketplace Rules.
In connection with the merger, the Company deposited with a third-party escrow agent
certificates representing 10% of the Aggregate Stock Consideration, which shares will be available
to compensate the Company and related parties for certain indemnifiable losses as described in the
merger agreement. On October 13, 2011, the escrow agent released
from the escrow 5% of the Aggregate Stock Consideration,
or 248,705 shares.
The Companys acquisition of Apthera was in concert with the decision by the Companys Board
of Directors to diversify its development programs and to become a late stage clinical development
company.
9
Table of Contents
The purchase price consideration and allocation of purchase price of Apthera were as follows:
(in 000s) | ||||
Calculation of allocable purchase price: |
||||
Fair value of shares issued at closing including escrowed shares expected to be released |
$ | 6,367 | (i) | |
Estimated value of earn-out |
6,460 | |||
Total allocable purchase price |
$ | 12,827 | ||
Allocation of purchase price: |
||||
Cash |
$ | 168 | ||
Prepaid expenses and other current assets |
14 | |||
Equipment and furnishings |
11 | |||
Goodwill |
845 | |||
In-process research and development |
12,864 | |||
Accounts payable |
(931 | ) | ||
Accrued expenses and other current liabilities |
(143 | ) | ||
Notes payable |
(1 | ) | ||
$ | 12,827 | |||
(i) | The value of the Companys common stock was based upon a per share value of $1.28, the closing price of the Companys common stock as of the close of business on April 13, 2011. |
The
estimated value of earn-out of $6.5 million originally recorded was based on the
expected probability of achievement in the future of certain development and commercial
milestones relating to the Companys
NeuVaxTM product candidate and then applying a
discount rate, based on a corporate debt interest rate index publicly issued, to the
expected future payments. The expected timing of the milestones, the probability of
success for each milestone and the discount rates applied are updated quarterly using the
most current information to measure the contingent liability as of the reporting date.
The decrease in the fair value of the contingent liability from date of issuance to
September 30, 2011 is $683,000, which was included in other income and expense in the
accompanying condensed statements of expenses for the nine months ended September
30, 2011. The fair value of the contingent liability at September 30, 2011 was
$5,777,000. Of this amount $1,632,000 was recorded as a current liability.
The
following presents the pro forma net loss and pro forma net loss per common share for the three and nine
months ended September 30, 2011 and 2010 of the Companys acquisition of Apthera assuming the
acquisition occurred as of January 1, 2010:
For the Three Months Ended September 30, | ||||||||
2011 | 2010 | |||||||
Net loss |
$ | (5,835 | ) | $ | (4,947 | ) | ||
Net loss per common share |
$ | (0.14 | ) | $ | (0.21 | ) | ||
Weighted average shares outstanding |
41,970,481 | 23,346,849 | ||||||
For the Nine months Ended September 30, | ||||||||
2011 | 2010 | |||||||
Net loss |
$ | (14,431 | ) | $ | (12,051 | ) | ||
Net loss per common share |
$ | (0.41 | ) | $ | (0.53 | ) | ||
Weighted average shares outstanding |
35,556,155 | 22,691,700 | ||||||
10
Table of Contents
3. RXi Pharmaceuticals Corporation
Contribution Agreement
On September 24, 2011, we entered into a contribution agreement with RXi pursuant to which we
assigned and contributed to RXi substantially all of our RNAi-related technologies and assets. The
contributed assets consist primarily of our novel RNAi compounds and licenses relating to our RNAi
technologies, as well as the lease of our Worcester, Massachusetts laboratory facility, fixed
assets and other equipment located at the facility and our employment arrangements with certain
scientific, corporate and administrative personnel who have become employees of RXi. We also
have contributed $1.5 million of cash to the capital of RXi.
Pursuant to the contribution agreement, RXi has agreed to assume certain recent accrued
expenses of our RXi-109 development program and all future obligations under the contributed
licenses, employment arrangements and other agreements. RXi has also agreed to make future
milestone payments to us of up to $45 million, consisting of two one-time payments of $15 million
and $30 million, respectively, if RXi achieves annual net sales equal to or greater than $500
million and $1 billion, respectively, of any covered products that may be developed with the
contributed RNAi technologies.
In the contribution agreement, we have made customary representations and warranties to RXi
regarding the contributed assets and other matters, and the parties have agreed to customary
covenants regarding the conduct of RXis business pending the spin-off of RXi. The parties
also have agreed to indemnify each other against losses arising from a breach of their respective
representations, warranties and covenants set forth in the contribution agreement.
Securities Purchase Agreement
On September 24, 2011, we also entered into a securities purchase agreement with RXi and two
institutional investors (the investors), pursuant to which the investors agreed to purchase a
total of $9,500,000 of Series A Preferred Stock of RXi (RXi Preferred Stock) at the closing of
the spin-off of RXi, and to lend up to $1,500,000 to RXi to fund its operations between signing and
closing (the Bridge Loan). The outstanding principal and accrued interest from the Bridge Loan
will, except under certain circumstances described below, be converted into RXi Preferred Stock at
the closing of the spin-off of RXi and will represent a portion of the $9,500,000 total investment,
which is referred to herein as the RXi financing. The RXi financing and the spin-off of
RXi are subject to customary closing conditions, including the registration under the Securities
Act of 1933, as amended (the Securities Act), of the distribution by us of the spin-off shares.
There is no assurance that the RXi financing and the spin-off of RXi will be completed.
The RXi Preferred Stock will be convertible by a holder at any time into shares of RXi common
stock, except to the extent that the holder would own more than 9.999% of the shares of RXi common
stock outstanding immediately after giving effect to such conversion. Without regard to this
conversion limitation, the shares of the Preferred Stock to be held by the investors upon
completion of the RXi financing and the spin-off of RXi will be convertible into shares of RXi
common stock representing approximately 83% of the shares of RXi common stock that would be
outstanding, assuming the conversion in full of the Preferred Stock, which we refer to as the
as-converted common stock. We will own approximately 12% of the as-converted common stock
immediately prior to the
spin-off of RXi, and Advirna, LLC, a key licensor of RXi, will be issued the remaining 5% of
the as-converted common stock pursuant to the agreement with Advirna, LLC as described below.
Spin-Off
We have agreed in the securities purchase agreement to undertake to distribute to our
stockholders on a share-for-share basis approximately 8% of the
as-converted common stock of RXi, subject
to the registration of the distribution of such shares under the
Securities Act of 1933, as amended (the Securities Act) and other
conditions. Assuming the spin-off of RXi is completed, we will initially retain 4% of the
as-converted common stock, and we have agreed, in the securities purchase agreement, not to sell or
dispose of our shares of RXi common stock for a one-year period following completion of the
spin-off of RXi. The securities purchase agreement provides that the spin-off will be on a
share-for-share basis, so that one share of RXi will be distributed as a dividend on each share of
Galena that is issued and outstanding as of a record date to be determined prior to the spin-off.
Accordingly, the capitalization of RXi has not yet been established and the actual number of
spin-off shares, as well as the actual shares of common stock of RXi to be outstanding upon
completion of the spin-off of RXi, are not yet known and will be determined at a subsequent
time closer to the completion of the spin-off.
Purchase Agreement Terms and Conditions
In the securities purchase agreement, the parties have made customary representations and
warranties to the other parties and have agreed to customary covenants regarding the parties
actions in connection with the spin-off of RXi and other matters, including
11
Table of Contents
the filing of a
resale registration statement registering a portion of the common stock underlying the conversion
of the Preferred Stock. The parties also have agreed to indemnify each other against losses arising
from a breach of their respective representations, warranties and covenants set forth in the
securities purchase agreement. RXi has agreed, upon completion of the spin-off of RXi, to
reimburse Galena and the investors for up to a total of $250,000 and $100,000, respectively, of
transaction costs relating to the contribution agreement, the securities purchase agreement and the
transactions contemplated by the agreements.
The securities purchase agreement may be terminated in certain circumstances, including by the
investors or us if the spin-off of RXi has not occurred by February 22, 2012. If the
securities purchase agreement is terminated without cause due to the fact that the spin-off has not
occurred by such date, then a portion of the Bridge Loan will be converted into common stock of
RXi, as described below.
Bridge Loan
Pursuant to the securities purchase agreement, the investors have agreed to provide the Bridge
Loan by purchasing $500,000 of secured convertible promissory notes of RXi (RXi convertible
notes) and agreeing to purchase up to an additional $1 million of RXi convertible notes prior to
the closing of the spin-off or RXi. The RXi convertible notes will, except as described below, be
convertible into shares of RXi Preferred Stock at a conversion price of $1,000 per share. The
proceeds from the Bridge Loan will be used by RXi in accordance with an operating budget approved
by the investors to fund RXis business and operations pending completion of the spin-off of RXi.
The RXi convertible notes accrue interest at a rate of 7% per annum (or 18% per annum in the
case of an event of default) and mature on February 22, 2012, or earlier in the case of an event of
default. The obligations due under the RXi convertible notes are secured by a first-priority
blanket lien on the assets of RXi and are guaranteed by Galena. Additionally, Galena has pledged
all of the shares of RXi common stock that it holds to further guaranty the timely repayment of the
amounts due under the RXi convertible notes, if not converted into RXi Preferred Stock at the closing under the
securities purchase agreement.
The RXi convertible notes will be issued, and the Bridge Loan will be funded, in three
tranches of $500,000 each, with the initial tranche issued and funded on September 24, 2011 and the second and
third tranches to be issued and funded following the approval by the investors, in their discretion, of
operating budgets for RXi during the period between September 24, 2011 and closing under the
securities purchase agreement.
If the closing under the securities purchase agreement has not occurred by
the February 22, 2012 maturity date of the RXi convertible notes, then 50% of the outstanding
Bridge Loan balance will be converted into a number of shares of RXi common stock equal to 51% of
the post-conversion shares outstanding. RXi will remain obligated to repay the remaining balance of
the principal and accrued interest under the Bridge Loan, and Galena has agreed to guarantee RXis
repayment of the RXi convertible notes to the extent they are not converted. In this event, Galena
and Advirna, LLC will beneficially own 44% and 5%, respectively, of the
outstanding shares of RXi common stock, and RXi will carry on as a stand-alone private company
under the investors control. Neither the investors nor Galena will be obliged to provide any
funding to RXi in this event.
At
September 30, 2011, the first tranche of $500,000 was received and
recorded to convertible notes payable as a current liability. There
are additional features of the Series A Convertible Preferred Stock
which represent contingent beneficial conversion features, to be
reevaluated in the future. In the event that the facts and
circumstances indicate that a contingency is removed, at that point
the beneficial conversion feature, if any, will be recorded.
Advirna Agreement
As part of the transactions contemplated by the contribution and securities purchase
agreements, RXi has entered into an agreement with Advirna, LLC, which we refer to as Advirna, a
company affiliated with Anastasia Khvorova, Ph.D., RXis Senior Vice President and Chief Scientific
Officer. In the agreement, Advirna has agreed to amend its existing patent and technology
assignment agreement with RXi to eliminate all clinical milestone and royalty payments to Advirna
under the amended agreement; obligations remain to make an annual $100,000 maintenance fee and a
one-time milestone payment of $350,000 to Advirna upon the issuance of a patent with valid claims
covering the assigned technology. Additionally, RXi will be required to pay a 1% royalty to Advirna
for any licensing revenue received by RXi on the license of the assigned Advirna technology. In
exchange, RXi has agreed to issue to Advirna upon the earlier of the closing under the securities
purchase agreement or the partial conversion of the RXi convertible notes, a number of shares of
RXi common stock equal to 5% of the as-converted common stock of RXi.
4. Fair Value Measurements
Effective January 1, 2008, the Company implemented FASB ASC Topic 820, Fair Value
Measurements and Disclosures (ASC 820), for the Companys financial assets and liabilities that
are re-measured and reported at fair value at each reporting period, and are
12
Table of Contents
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 defined as follows:
Level 1 quoted prices in active markets for identical assets or liabilities.
Level 2 other significant observable inputs for the assets or liabilities through corroboration
with market data at the measurement date.
Level 3 significant unobservable inputs that reflect managements best estimate of what market
participants would use to price the assets or liabilities at the measurement date.
The Company categorized its cash equivalents as a Level 1 hierarchy. The valuation for Level 1
was determined based on a market approach using quoted prices in active markets for identical
assets. Valuations of these assets do not require a significant degree of judgment. The Company
categorized its warrants potentially settleable in cash as a Level 2 hierarchy. The warrants are measured at market value on a recurring basis and are
being marked to market each quarter-end until they are completely settled. The warrants are valued
using the Black-Scholes method, using assumptions consistent with our application of ASC 718.
The contingent purchase price consideration is categorized as a Level
3 hierarchy and is measured at its estimated fair value on a recurring basis and is adjusted at each quarter-end until
it is completely settled. The contingent price consideration is valued based on the expected timing of milestones, the expected probability of success for each milestone and the
updated discount rates based on a corporate
debt interest rate index publicly issued.
Quoted | ||||||||||||||||
Prices | Significant | |||||||||||||||
in | Other | Observable | Unobservable | |||||||||||||
September 30, | Active Markets | Inputs | Inputs | |||||||||||||
Description | 2011 | (Level 1) | (Level 2) | (Level 3) | ||||||||||||
Assets: |
||||||||||||||||
Cash equivalents |
$ | 15,693 | $ | 15,693 | $ | | $ | | ||||||||
Total assets |
$ | 15,693 | $ | 15,693 | $ | | $ | | ||||||||
Liabilities: |
||||||||||||||||
Warrants potentially settleable in cash |
$ | 15,226 | $ | | $ | 15,226 | $ | | ||||||||
Contingent purchase price consideration |
5,777 | | | 5,777 | ||||||||||||
Total liabilities |
$ | 21,003 | $ | | $ | 15,226 | $ | 5,777 | ||||||||
Quoted | ||||||||||||||||
Prices | Significant | |||||||||||||||
in | Other | |||||||||||||||
Active | Observable | Unobservable | ||||||||||||||
December 31, | Markets | Inputs | Inputs | |||||||||||||
Description | 2010 | (Level 1) | (Level 2) | (Level 3) | ||||||||||||
Assets: |
||||||||||||||||
Cash equivalents |
$ | 6,891 | $ | 6,891 | $ | | $ | | ||||||||
Total assets |
$ | 6,891 | $ | 6,891 | $ | | $ | | ||||||||
Liabilities: |
||||||||||||||||
Warrants potentially settleable in cash |
$ | 3,138 | $ | | $ | 3,138 | $ | | ||||||||
Total liabilities |
$ | 3,138 | $ | | $ | 3,138 | $ | | ||||||||
13
Table of Contents
Fair Value of Financial Instruments
The carrying amounts reported in the balance sheet for cash equivalents, accounts payable,
capital leases, and convertible notes approximate their fair values due to their short-term nature
and market rates of interest.
5. Stock Based Compensation
The Company follows the provisions of the FASB ASC Topic 718, Compensation Stock
Compensation (ASC 718), which requires the measurement and recognition of compensation expense
for all share-based payment awards made to employees and non-employee directors,
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 option grants issued in the three and nine month periods ended
September 30, 2011 and 2010, the following assumptions were used:
For the Three Months Ended September 30, | For the Nine months Ended September 30, | |||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
Weighted average risk-free interest rate |
1.03% | N/A | 1.59% | 3.02% | ||||||||||||
Weighted average expected volatility |
98.94% | N/A | 103.27% | 121.19% | ||||||||||||
Weighted average expected lives (years) |
5.34 | N/A | 5.49 | 7.37 | ||||||||||||
Weighted average expected dividend yield |
0.00% | N/A | 0.00% | 0.00% |
The
weighted average fair value of options granted during the nine-month period ended September
30, 2011 and 2010 was $0.91 and $4.34 per share, respectively.
The weighted average fair value of options granted during the three-month period ended September
30, 2011 and 2010 was $0.66 and $4.87 per share, respectively.
Galenas 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. 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 Galena 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. Galena has estimated an annualized forfeiture rate of
15.0% for options granted to its employees, 8.0% for options granted to senior management and no
forfeiture rate for the directors. Galena 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.
14
Table of Contents
The following table summarizes stock option activity from January 1, 2011 through September 30,
2011:
Weighted | ||||||||||||
Average | Aggregate | |||||||||||
Total Number | Exercise | Intrinsic | ||||||||||
of Shares | Price | Value | ||||||||||
Outstanding at January 1, 2011 |
4,333,136 | $ | 5.10 | $ | 137,000 | |||||||
Granted |
3,262,500 | 0.87 | 167,250 | |||||||||
Exercised |
| | | |||||||||
Cancelled |
1,144,067 | 4.22 | | |||||||||
Outstanding at September 30, 2011 |
6,451,569 | $ | 3.29 | $ | 167,250 | |||||||
Options exercisable at September 30, 2011 |
4,652,517 | $ | 3.71 | $ | 94,500 | |||||||
The aggregate intrinsic values of outstanding and exercisable options at September
30, 2011 were calculated based on the closing price of the Companys common stock on September 30,
2011 of $1.01 per share less the exercise price of those shares. The aggregate intrinsic values of
options exercised were calculated based on the difference, if any, between the exercise price of the
underlying awards and the quoted price of the Companys common stock on the date of exercise.
6. Net Loss Per Share
The Company accounts for and discloses net loss per common share in accordance with FASB ASC
Topic 260 Earnings per Share. Basic net loss per common share is computed by dividing net loss
attributable to common stockholders by the weighted average number of common shares outstanding.
Diluted net loss per common share is computed by dividing net loss attributable to common
stockholders by the weighted average number of common shares that would have been outstanding
during the period assuming the issuance of common shares for all potential dilutive common shares
outstanding. Potential common shares consist of shares issuable upon the exercise of stock options
and warrants. Because the inclusion of potential common shares would be anti-dilutive for all
periods presented, diluted net loss per common share is the same as basic net loss per common
share.
The following table sets forth the potential common shares excluded from the calculation of
net loss per common share because their inclusion would be anti-dilutive:
September 30, | ||||||||
2011 | 2010 | |||||||
Options to purchase common stock |
6,451,569 | 4,319,312 | ||||||
Warrants to purchase common stock |
20,050,642 | 2,100,642 | ||||||
Total |
26,502,211 | 6,419,954 | ||||||
7. License Agreements
As part of its business, the Company enters into licensing agreements that 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, Galena is required to make royalty payments based upon a
percentage of product sales.
An individual milestone payment required under the licensing arrangements may be material, and
in the event that multiple milestones are reached in the same period, the aggregate payments
associated with the milestones could adversely affect the results of operations or affect the
comparability of our period-to-period results. In addition, these licensing arrangements often give
the Company the discretion to unilaterally terminate development of the product, which would allow
the Company to avoid making the contingent payments; however, the Company is unlikely to cease
development if the compound successfully achieves clinical testing objectives.
15
Table of Contents
In conjunction with the acquisition of Apthera, the Company assumed
the rights and obligations of a certain license agreement, as
amended, from The University of Texas M. D. Anderson Cancer Center
(MDACC) and The Henry M. Jackson Foundation for the
Advancement of Military Medicine, Inc. (HJF) which grants
exclusive worldwide rights to the use of composition for one patent
and one patent applications involving the use of the E75 peptide.
Under the terms of this license, we are required to make future
annual maintenance fee payments, as well as clinical milestone
payments and royalty payments based on sales of therapeutic products
developed from the licensed technologies. As part of the expected
payments under the terms of the license, the Company must pay an
annual maintenance fee of $175,000 in 2011 and $200,000 in 2012. In
addition, upon commencing the Phase 3 trial, we will pay a milestone
payment of $200,000. We expect commencement of the Phase 3 trial to
occur by the first half of 2012. In July 2011, the Company entered into a
subsequent non-exclusive license agreement with HJF which grants two
patent rights and two patent applications relating to the use of the
E75 peptide. As part of the expected payments under the terms of the
license, the Company paid an issue royalty fee of $100,000. In
addition, the Company must pay an annual maintenance fee of $50,000
($25,000 for each patent) and royalties based on net sales upon
commercialization.
8. Stockholders Equity and Warrant Liabilities
2011 Financings
On September 26, 2011, the Company completed a direct offering of 700,000 shares of common
stock for gross proceeds of $455,000.
On April 20, 2011, the Company completed an underwritten public offering of 11,950,000 units
at a price to the public of $1.00 per unit for gross proceeds of approximately $12 million (the
April 2011 Offering). Each unit consisted of one share of common stock and a warrant to purchase
one share of common stock at an exercise price of $1.00 per share (subject to anti-dilution adjustment). The shares of common stock and
warrants were immediately separable and no separate units were issued. The warrants are exercisable
beginning one year and one day from the date of issuance, and expire on the sixth anniversary of
the date of issuance. Net proceeds, after underwriting discounts and commissions and other offering
expenses, were approximately $10.9 million. As a result of the subsequent offering that was
completed on September 26, 2011, the exercise price of the 11,950,000 outstanding
warrants sold in the April 2011 Offering was reduced to $0.65 per share as a result of the
anti-dilution adjustment.
On March 4, 2011, the Company closed an underwritten public offering of 6,000,000 units at a
price to the public of $1.35 per unit for gross proceeds of $8.1 million (the March 2011
Offering). The offering provided approximately $7.3 million to the Company after deducting the
underwriting discounts and commissions and offering expenses. Each unit consists of (i) one share
of common stock, (ii) a thirteen-month warrant to purchase 0.50 of a share of common stock at an
exercise price of $1.70 per share (subject to anti-dilution adjustment) and (iii) a five-year
warrant to purchase 0.50 of a share of common stock at an exercise price of $1.87 per share
(subject to anti-dilution adjustment). On April 15, 2011, the holders of outstanding warrants
issued in the March 2011 Offering to purchase an aggregate of 3,450,000 shares of common stock
agreed to exchange such warrants for warrants exercisable for the same number of shares as those
being exchanged, but otherwise on the same terms of the warrants sold in the Companys April 2011
financing. Prior to the exchange, the Company recorded a decrease in fair value of $1,000,000
related to the exchanged warrants. Upon the exchange, the Company recorded a loss of $900,000,
which represented the difference between the adjusted fair value of the March 2011 warrants as
compared to the fair value of the April 2011 warrants received in the exchange. As a result of a
subsequent offering that was completed on April 15, 2011, the exercise price of the remaining
2,550,000 outstanding warrants sold in the March 2011 Offering was reduced to $1.00 per share as a
result of the anti-dilution adjustment. At September 30, 2011, 150,000 warrants from the March 2011
Offering had been exercised with a remaining outstanding balance of 5,850,000. As a result of the
subsequent offering on September 26, 2011, the exercise price of the remaining 5,850,000
warrants sold in the March 4, 2011 Offering were reduced to $0.65 per share as a result of the
anti-dilution adjustment.
Warrants Potentially Settleable in Cash
Certain warrants issued in connection with a registered direct stock offering on August 3,
2009 (the 2009 Offering) were determined not to be indexed to the Companys common stock as they
are potentially settleable in cash. The fair value of the warrants at the dates of issuance
totaling $2,863,000 was recorded as a liability and a cost of equity and was determined by the
Black-Scholes option pricing model. Due to the fact that the Company has limited trading history,
the Companys expected stock volatility assumption is based on a combination of implied
volatilities of similar entities whose shares or options are publicly 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 the Company has
no present intention to pay cash dividends. The risk free rate of 1.72% used for the warrants is
equal to the zero coupon rate in effect at the time of the grant. The decrease in the fair value of
the warrants from the date of issuance to September 30, 2011 is $2,576,000, of which $1,656,000 has
been included in other income and expense in the accompanying condensed statements of expenses for
the nine months ended September 30, 2011. The fair value of the warrants at September 30, 2011 of
$286,000 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 the Company has limited trading
history, the Companys expected stock volatility assumption is based on a combination of implied
volatilities of similar entities whose shares or options are publicly traded. The Company used a
weighted average expected stock volatility of 98.93%. The expected life assumption is based on the
remaining contract term of 2.8 years. The dividend yield of zero
is based on the fact that we have no present intention to pay
16
Table of Contents
cash dividends. The risk free rate of 0.42% used for the warrants is
equal to the zero coupon rate in effect on the date of the re-measurement.
Certain warrants issued in connection with the March 22, 2010 stock offering (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 using the Black-Scholes option
pricing model. Due to the fact that the Company has limited trading history, our expected stock
volatility assumption is based on a combination of implied volatilities of similar entities whose
shares or options are publicly 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 warrants 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 date of
issuance to September 30, 2011 is $2,142,000, of which $871,000 has been included in other income
and expense in the accompanying condensed statements of expenses for the nine months ended
September 30, 2011. The fair value of the warrants at September 30, 2011 of $324,000 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 the Company has limited trading history, the Companys
expected stock volatility assumption is based on a combination of implied
volatilities of similar entities whose shares or options are publicly traded. The Company used a
weighted average expected stock volatility of 98.93%. The expected life assumption is based on the
remaining contract term of 5.0 years. The dividend yield of zero is based on the fact that the
Company has no present intention to pay cash dividends. The risk free rate of 0.96% used for the
warrants is equal to the zero coupon rate in effect on the date of the re-measurement.
The thirteen-month and five-year warrants issued in connection with the March 2011 Offering
were determined not to be indexed to the Companys common stock as they are potentially settleable
in cash. The fair value of the remaining 2,550,000 warrants at the date of issuance totaling
$1,790,000 was recorded as a liability and a cost of equity and was determined using the
Black-Scholes option pricing model. Due to the fact that the Company has limited trading history,
the Company expected stock volatility assumption is based on a combination of implied volatilities
of similar entities whose shares or options are publicly traded. The Company used a weighted
average expected stock volatility of 113.25%. The expected life assumption is based on the contract
term of 1.08 years used for the thirteen-month warrants and 5 years used for the five-year
warrants. 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 0.26% used for the thirteen-month warrants and 2.17% used for
the five-year warrants is equal to the zero coupon rate in effect at the time of the
grant.
In July 2011, 75,000 of the thirteen-month warrants were exercised at
$1.00 per common share which resulted in a $34,000 reduction of warrant liability. In July 2011, 75,000 of the
five-year warrants were exercised at $1.00 per common share
which resulted in a $68,000 reduction of warrant liability.
The decrease in the fair value of the warrants from date of issuance to September 30, 2011
of $318,000 has been included in other income and expense in the accompanying condensed statements
of expenses for the nine months ended September 30, 2011. The fair value of the warrants at
September 30, 2011 of $1,473,000 is included as a current liability in the accompanying balance
sheets and was determined using the Black-Scholes option pricing model. Due to the fact that the
Company has limited trading history, the Companys expected stock volatility assumption is based on
a combination of implied volatilities of similar entities whose shares or options are publicly
traded. The Company used a weighted average expected stock volatility of 98.93%. The expected life
assumption is based on the remaining contract term of one year used for the thirteen-month warrants
and 4.4 years used for the five- year warrants. The dividend yield of zero is based on the fact
that the Company has no present intention to pay cash dividends. The risk free rate of 0.06% used
for the thirteen-month warrants and 0.96% used for the five-year warrants is equal to the zero
coupon rate in effect on the date of the re-measurement.
The warrants issued in connection with the April 2011 Offering, including the warrants issued
in exchanged for the March 2011 warrants, 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 $11,442,000 was recorded as a liability and a cost of equity and was determined
using the Black-Scholes option pricing model. Due to the fact that the Company has limited trading
history, the Companys expected stock volatility assumption is based on a combination of implied
volatilities of similar entities whose shares or options are publicly traded. The Company used a
weighted average expected stock volatility of 99.04%. The expected life assumption is based on the
contract term of 7.0 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 2.81% used for the warrants is equal to the
zero coupon rate in effect at the time of the grant. The increase in the fair value of the warrants
from date of issuance to September 30, 2011 is $1,701,000, of which all has been included in other
income and expense in the accompanying condensed statements of expenses for the nine months ended
September 30, 2011. The fair value of the warrants at September 30, 2011 of $13,143,000 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 the Company has limited trading history, the Companys
expected stock volatility assumption is based on a combination of implied volatilities of similar
entities whose shares or options are publicly traded. The Company used a weighted average expected
stock volatility of 98.93%. The expected life assumption is based on the remaining contract term of
6.6 years. The dividend yield of zero is based on the fact that the Company has no present
intention to pay cash dividends. The risk free rate of 1.43% used for the warrants is equal to the
zero coupon rate in effect on the date of the re-measurement.
17
Table of Contents
Stock Options Modified
On April 14, 2011, all of the Companys directors and certain of the Companys executive
officers executed agreements with the Company under which they agreed that none of their
outstanding stock options will be exercisable unless and until the Company increases the number of
authorized shares of common stock to a number that is sufficient to permit the exercise or
conversion in full of all then outstanding options of the Company (including their stock options),
warrants and other securities of the Company that are convertible into shares of common stock. An
aggregate of 3,489,256 option shares are covered by these agreements. For accounting purposes, the
agreement of all of the Companys directors and certain executive officers to place restrictions of
the exercisability of their options is treated as a modification of their options resulting in the
reclassification of the options from equity to a liability. In connection with the modification,
the Company will recognize compensation cost equal to the greater of (a) the grant date fair value
of the original equity award plus an incremental cost associated with the modification or (b) the
fair value of the modified award when it is settled. On July 15, 2011, the Board of Directors of
the Company adopted an amendment to increase the authorized shares of common stock to 125,000,000,
which was presented to and approved by the stockholders of the Company at the 2011 Annual Meeting
of Stockholders. This increase in the authorized shares was sufficient to permit the exercise or
conversion in full of all then outstanding options of the Company (including their stock options),
warrants and other securities of the Company that are convertible into shares of common stock, as a
result, the liability was marked to market through July 15, 2011 and, upon settlement, the value of
$1,036,000 was reclassified to additional paid in capital.
Other
Equity Transactions
On March 30, 2011, the Company entered into a severance agreement with its former President
and Chief Executive Officer whereby, among other things, it agreed to issue shares to the former
officer such that the number of shares issued times the market price of the shares on the day
immediately following the separation date equal a value of $300,000. The agreement further provides
that the Company will, at its option, provide a cash payment or additional shares to the former
officer if necessary such that the value of 1/3 of the shares issued and 2/3 of the shares issued,
respectively, at the separation date equal a guaranteed value of $100,000 as of the
90th day following the separation date and $200,000 as of the
180th day following the separation date based on the closing price of the Companys
common stock for the five days preceding each measurement date. As of September 30, 2011, all
payments and shares due under this severance agreement have been issued and recorded to stock compensation expense.
9. Recent Accounting Pronouncements
Effective January 1, 2010, the Company adopted Accounting Standards Update (ASU) No. 2010-06,
Fair Value Measurements and Disclosures (Topic 820): Improving Disclosures about Fair Value
Measurements, or ASU 2010-06. A reporting entity should provide additional disclosures about the
different classes of assets and liabilities measured at fair value, the valuation techniques and
inputs used, the activity in Level 3 fair value measurements, and the transfers between Levels 1,
2, and 3 fair value measurements. The adoption of the additional disclosures for Level 1 and Level
2 fair value measurements did not have an impact on the Companys financial position, results of
operations or cash flows. The disclosures regarding Level 3 fair value measurements were adopted by
the Company January 1, 2011 and did not have an impact on the Companys financial position, results
of operations or cash flows or require additional disclosures.
In December 2010, the FASB issued ASU No. 2010-28, Intangibles Goodwill and Other (Topic
350): When to Perform Step 2 of the Goodwill Impairment Test for Reporting Units with Zero or
Negative Carrying Amounts. ASU 2010-28 is effective for fiscal years beginning after December 15,
2010 and amends the criteria for performing Step 2 of the goodwill impairment test for reporting
units with zero or negative carrying amounts and requires performing Step 2 if qualitative factors
indicate that it is more likely than not that a goodwill impairment exists. We do not believe that this will have a material
impact on our consolidated financial statements.
18
Table of Contents
In December 2010,
the FASB issued ASC Update 2010-29, Business Combinations (Topic
805):
Disclosure of Supplementary Pro Forma Information for Business
Combinations (Update No. 2010-29).
This Update requires a public entity to disclose pro forma information for business combinations
that occurred in the current reporting period. The disclosures include pro forma revenue and
earnings of the combined entity for the current reporting period as though the acquisition date for
all business combinations that occurred during the year had been as of the beginning of the annual
reporting period. If comparative financial statements are presented, the pro forma revenue and
earnings of the combined entity for the comparable prior reporting period should be reported as
though the acquisition date for all business combinations that occurred during the current year had
been as of the beginning of the comparable prior annual reporting period. This Update affects any
public entity that enters into business combinations that are material on an individual or
aggregate basis and is effective prospectively for business combinations for which the acquisition
date is on or after the beginning of the first annual reporting period beginning on or after
December 15, 2010. The Company adopted updated No. 2010-29 beginning January 1, 2011. The financial
statements have been updated to reflect the adoption of this pronouncement.
In
May 2011, the FASB issued Accounting Standards Updated
(ASU) 2011-04, Fair Value Measurement (Topic
820): Amendments to Achieve Common Fair Value Measurement and
Disclosure Requirements in U.S. GAAP and IFRSs, a new accounting standard that clarifies the application of
certain existing fair value measurement guidance and expands the disclosures for fair value
measurements that are estimated using significant unobservable (Level 3) inputs. This new standard
is effective on a prospective basis for annual and interim reporting periods beginning on or after
December 15, 2011. The Company does not expect that adoption of this new standard will have a
material impact on its condensed consolidated financial statements.
In
June 2011, the FASB issued ASU 2011-05, Comprehensive Income
(Topic 220): Presentation of
Comprehensive Income, a new accounting standard that eliminates the option to present
the components of other comprehensive income as part of the statement of changes in stockholders
equity, requires the consecutive presentation of the statement of net income and other
comprehensive income and requires an entity to present reclassification adjustments on the face of
the financial statements from other comprehensive income to net income. The amendments in this new
standard do not change the items that must be reported in other comprehensive income or when an
item of other comprehensive income must be reclassified to net income nor do the amendments affect
how earnings per share is calculated or presented. This new standard is required to be applied
retrospectively and is effective for fiscal years and interim periods within those years beginning
after December 15, 2011. As this new standard only requires enhanced disclosure, the adoption of
this standard will not impact the Companys condensed consolidated financial statements.
10. Subsequent Events
The Company evaluated all events or transactions that occurred after September 30, 2011 up
through the date these financial statements were issued. Other than what is disclosed below, during
this period or in Note 2 regarding the release of the escrow shares, the Company did not have any material recognizable or unrecognizable subsequent
events.
RXi Registration Statement
On October 25, 2011, RXi filed a registration statement with the Securities and Exchange
Commission to register the shares of RXi common stock that Galena proposes to distribute to its
stockholders in the spin-off of RXi from Galena. The distribution will be made to Galena
stockholders as of the record date for the distribution, which is expected to be ten days after the
registration statement is declared effective by the Securities and Exchange Commission.
The spin-off, itself, and the permanent financing of RXi described in Note 3, are
subject to certain conditions, including the completion of the registration of the spin-off with
the SEC. It is anticipated that the RXi common shares will be listed
for trading on an appropriate stock exchange or quotation service following the spin-off.
Warrant Purchase Demand
On October 28, 2011, we received a letter from Hudson Bay Master Fund, Ltd. (Hudson Bay) in
which Hudson Bay alleges that the filing by us on September 26, 2011 of a Certificate of Ownership
and Merger with the Delaware Secretary of State constituted a Fundamental Transaction within the meaning of a warrant to purchase up to 1,930,000 shares
of our common stock held by Hudson Bay and elects to exercise a purported option under its warrant
to require us to purchase the warrant for cash in the amount of $1,371,651. According to Hudsons
Bays letter, this is the value of Hudson Bays warrant as determined based on the Black-Scholes
valuation method using the valuation criteria specified in the warrant.
The Certificate of Ownership was filed to cover our merger with a
wholly owned subsidiary for the sole purpose of changing our name
from RXi Pharmaceuticals Corporation to Galena Biopharma, Inc.
We believe that no Fundamental Transaction within the meaning of our outstanding warrants
has occurred and that we are not obliged to purchase Hudson Bays warrant, and have so notified
Hudson Bay. We cannot predict the outcome of this matter.
19
Table of Contents
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
In this document, we, our, ours, us, Galena and the Company refer to Galena Biopharma,
Inc., together with RXi Pharmaceuticals Corporation and Apthera, Inc., Galenas wholly owned
subsidiaries.
This managements discussion and analysis of financial condition as of September 30, 2011 and
results of operations for the three months and nine months ended September 30, 2011 and 2010 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, 2010 which
was filed with the SEC on April 15, 2011.
The discussion and analysis below includes certain forward-looking statements related to future
operating losses and our potential for profitability, the sufficiency of our cash resources, our
ability to obtain additional equity or debt financing, possible partnering or other strategic
opportunities for the development of our products, as well as other statements related to the
progress and timing of product development, present or future licensing, collaborative or financing
arrangements or that otherwise relate to future periods, which are all forward-looking statements
as defined by the Private Securities Litigation Reform Act of 1995. These statements represent,
among other things, the expectations, beliefs, plans and objectives of management and/or
assumptions underlying or judgments concerning the future financial performance and other matters
discussed in this document. The words may, will, should, plan, believe, estimate,
intend, anticipate, project, and expect and similar expressions are intended to identify
forward-looking statements. All forward-looking statements involve certain risks, uncertainties and
other factors described elsewhere in this report and in our Annual Report on Form 10-K for the year ended December 31,
2010, 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
Galena Biopharma, Inc. (NASDAQ: GALE) is a biotechnology company focused on discovering,
developing and commercializing innovative therapies addressing major unmet medical needs using
targeted biotherapeutics. Galena is pursuing the development of novel cancer therapeutics using
peptide-based immunotherapy products, including our main product candidate, NeuVax (E75), for the
treatment of various cancers.
On September 26, 2011, we changed the name of our company from RXi Pharmaceuticals Corporation
to Galena Biopharma, Inc. in connection with our planned separation into two companies: (i) Galena,
which will operate as a late-stage oncology drug development company; and (ii) RXi Pharmaceuticals
Corporation (RXi), which is a newly formed subsidiary of Galena that will continue to develop
novel RNAi-based therapies utilizing our historical RNAi assets
described in Note 3. RXi
was initially incorporated as RNCS, Inc. and assumed the name RXi Pharmaceuticals Corporation in
conjunction with the change in our name to Galena. Unless the context otherwise indicates,
references in these Notes to the company, we, us or our prior to the proposed separation,
or spin-off, of RXi from Galena collectively refer to Galena, RXi, and our other wholly owned
subsidiary, Apthera, Inc. (Apthera).
Our new RXi subsidiary was formed by us in agreement with two institutional investors. On
September 24, 2011, we contributed to RXi substantially all of our RNAi-related technologies and
assets and entered into a number of agreements relating to RXis ongoing business and operations.
RXi will focus on developing and commercializing therapeutic products based on RNAi
technologies for the treatment of human diseases, including its lead anti-scarring and
anti-fibrosis product candidate, RXI-109, with initial financing to be provided by us and the
institutional investors. In these agreements, we have committed, among other things, to undertake
to distribute to our stockholders a portion of the RXi common stock held by Galena in order to
accomplish the spin-off of RXi.
To date, RXis activities have consisted of completing its organizational activities,
acquiring our RNAi-related assets and entering into the agreements described in Note 3 of the
accompanying Notes to Financial Statements.
20
Table of Contents
The Company has not generated any revenues since inception nor are any revenues expected for
the foreseeable future. The Company expects to incur significant operating losses for the
foreseeable future while the Company advances its future product candidates from discovery through
pre-clinical studies and clinical trials and seek regulatory approval and potential
commercialization, even if the Company is collaborating with pharmaceutical and larger
biotechnology companies. In addition to these increasing research and development expenses, the
Company expects general and administrative costs to increase as the Company recruits additional
management and administrative personnel. The Company will need to generate significant revenues to
achieve profitability and may never do so.
Results of Operations
For the Three and Nine Months Ended September 30, 2011 and September 30, 2010
We reported a loss from operations of $5,076,000, which includes $1,011,000 of non-cash equity
based compensation, for the three months ended September 30, 2011 compared with a loss from
operations of $3,719,000, which includes $987,000 of non-cash equity compensation, in 2010. The
increase in loss of $1,357,000, or 36%, was due primarily to a $1,012,000 increase in research and
development expenses, an increase of $321,000 in general and
administrative expenses due to the focus on oncology related to the
Apthera acquisition, and an increase of $24,000 in non-cash equity compensation, as noted below.
We reported a loss from operations of $14,977,000, which includes $2,930,000 of non-cash
equity based compensation, for the nine months ended September 30, 2011 compared with a loss from
operations of $12,929,000, which includes $4,112,000 of non-cash equity based compensation, in
2010. The increase in loss of $2,048,000, or 16%, was due primarily to a $2,480,000 increase in
research and development expenses and an increase of $750,000 in general and administrative
expenses due to the focus on oncology related to the
Apthera acquisition, offset by
a decrease of $1,182,000 in non-cash equity based compensation, as noted below.
For the three months ended September 30, 2011, our net loss was approximately $5,475,000
compared with a net loss of $4,135,000 for the three months ended September 30, 2010. The increase
in net loss of $1,340,000 or 32% includes the loss from operations of $5,076,000 and $1,074,000 in
non-cash other expense related to the change in fair value of common stock warrants issued in
several financing transactions offset by $655,000 in non-cash other income related to the change in
fair value of our contingent purchase price consideration liability. The result was a net loss per
share of $0.13 and $0.23 for the three months ended September 30, 2011 and 2010, respectively.
Variations in the losses between the two periods are discussed below.
For the nine months ended September 30, 2011, our net loss was approximately $13,074,000
compared with a net loss of $10,162,000 for the nine months ended September 30, 2010. The increase
in net loss of $2,912,000, or 29%, includes the loss from operations of $14,977,000 offset by other
income of $1,042,000 related to the change in fair value of warrants issued in several financing
transactions, $683,000 in non-cash other income related to the change in fair value of our
contingent purchase price consideration liability, and government grant monies received. The result
was a net loss per share of $0.39 and $0.57 for the nine months ended September 30, 2011 and 2010,
respectively. 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 clinical trial preparation
costs, 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, development and clinical
activities.
Total research and development expenses were approximately $3,002,000 for the three months
ended September 30, 2011, compared with $1,936,000 for the three months ended September 30, 2010.
The increase of $1,066,000, or 55%, was primarily due to an increase of $1,012,000 in research and
development expenses due to a ramp up in NeuVax-related fees and
activities and an increase of $75,000 in employee non-cash stock based compensation offset by a
decrease of $21,000 in non-employee non-cash stock based compensation.
Total research and development expenses were approximately $7,835,000 for the nine months
ended September 30, 2011, compared with $6,126,000 for the nine months ended September 30, 2010.
The increase of $1,709,000, or 28%, was primarily due to an increase of $2,480,000 in research and
development expenses due to a ramp up in NeuVax-related fees and
activities, which was partially offset by a decrease of $764,000 in non-employee non-cash stock
based compensation and a $7,000 decrease in employee non-cash stock based compensation.
21
Table of Contents
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 $2,074,000 for the three months ended
September 30, 2011, compared with $1,783,000 for the three months ended September 30, 2010. The
increase of $291,000, or 16%, was primarily due to an increase of $321,000 in general and
administrative expenses and an increase of $105,000 in non-cash employee stock based
compensation offset by a decrease of $135,000 of non-cash non-employee stock based compensation
expense. Excluding these non-cash items, general and administrative expenses were approximately
$1,447,000 for the three months ended September 30, 2011, compared with $1,126,000 for the three
months ended September 30, 2010. The increase of $321,000 was primarily due to an increase in
expenses for professional services.
General and administrative expenses were approximately $7,142,000 for the nine months ended
September 30, 2011, compared with $6,803,000 for the nine months ended September 30, 2010. The
increase of $339,000, or 5%, was primarily due to an increase of $750,000 in general and
administrative expenses, an increase of $114,000 in employee non-cash stock based compensation
and a $23,000 increase due to non-cash stock based compensation expense offset by a decrease of
$548,000 in non-cash compensation related to a warrant issued for business advisory services.
Excluding these non-cash items, general and administration expense were approximately $4,978,000
for the nine months ended September 30, 2011, compared with $4,228,000 for the nine months ended
September 30, 2010. The increase of $750,000 was primarily due to severance payments in connection
with a reduction in force and an increase in expenses for professional services.
Interest Income
Interest income was negligible for the three and nine months ended September 30, 2011 and
2010. 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.
Other Income/Expense
Other income and expense for the three months ended September 30, 2011 was approximately expense of
$397,000, which includes $1,074,000 in non-cash expense related to a loss on the change in the fair
value of common stock warrants issued in connection with several financing transactions in 2009,
2010 and 2011 offset by $655,000 in non-cash income related to a gain on the change in the fair
value of our contingent purchase price consideration liability.
Other income and expense for the nine months ended September 30, 2011 was approximately income of
$1,909,000, which includes $1,042,000 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,
2010 and 2011, $683,000 in non-cash income related to a gain on the change in the fair value of our
contingent purchase price consideration liability and $186,000 of government grant monies received.
The fair value of the 2009, 2010 and 2011 warrants of $15,226,000 at September 30, 2011 is included
as a current liability in the accompanying balance sheets and were determined using the
Black-Scholes option pricing model.
Liquidity and Capital Resources
We had cash and cash equivalents of approximately $15.7 million as of September 30, 2011,
compared with $2.8 million as of September 30, 2010. We have not generated revenue to date and may
not generate product 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. We will need to generate significant revenues to achieve profitability and might never do
so. In the absence of product revenues, our potential sources of operational funding are
expected to be the proceeds from the sale of equity, funded research and development payments and
payments received under partnership and collaborative agreements.
As a result of our acquisition of Apthera and the expenses expected to be incurred in
connection with the Phase 3 clinical trial for NeuVax, we expect that our expenses will
increase from historic levels for the foreseeable future. We believe that our existing cash and
cash equivalents should be sufficient to fund our operations for the next twelve months. In the
future, we will be dependent on obtaining funding from third parties, such as proceeds from the
sale of equity, funded research and development payments and payments under partnership and
collaborative agreements, in order to maintain our operations and meet our obligations to
licensors. There is no guarantee that 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.
22
Table of Contents
Net Cash Flow from Operating Activities
Net
cash used in operating activities was approximately $10,499,000
for the nine months ended
September 30, 2011, compared with $8,388,000 for the nine months ended September 30, 2010. The
increase of approximately $2,111,000 resulted primarily from a net loss of $13,074,000, of which
$2,801,000 related to stock-based compensation, $23,000 related to common stock issued in exchange
for services, $106,000 related to stock warrant expense in exchange
for services, $126,000 related
to depreciation, a $7,000 loss on disposal of equipment, $900,000 related to the loss on exchange
of equity instruments, $1,942,000 that reflects the fair value of warrants and mandatorily
redeemable stock obligations issued in financings completed by the
Company in 2009, 2010 and 2011, $683,000 that reflects the fair value of
contingent purchase consideration
and $1,237,000 related to changes in current assets and liabilities.
Net Cash Flow from Investing Activities
Net cash used in investing activities was approximately $115,000 for the nine months ended
September 30, 2011, compared with $6,055,000 for the nine months ended September 30, 2010. The
decrease was primarily due to $168,000 in cash received from the Apthera acquisition offset by
$53,000 in purchases of equipment and furnishings in 2011 compared with $5,990,000 in the purchase
of short term investments and $65,000 in purchases of equipment and furnishing for the same period
in 2010.
Net Cash Flow from Financing Activities
Net
cash provided by financing activities was $19,186,000 for the nine months ended September
30, 2011, compared with $11,595,000 for the nine months ended September 30, 2010. The increase was
primarily due to net proceeds from the issuance of common stock in
the amount of $18,609,000 from
the March, April and September 2011 financings and the issuance of $500,000 in convertible notes payable, compared with net proceeds from the issuance of
common stock in the amount of $15,235,000 from the financing completed in the first half of 2010.
Off-Balance Sheet Arrangements
We have not entered into off-balance sheet financing, other than operating leases.
Critical Accounting Policies and Estimates
In our Annual Report on Form 10-K for the year ended December 31, 2010, 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, 2010. Readers are encouraged to review
these disclosures in conjunction with the review of this quarterly report on Form 10-Q.
ITEM 4. CONTROLS AND PROCEDURES
Disclosure Controls and Procedures
Our management, with the participation of our President, Chief Executive Officer and Chief
Financial Officer, performed an evaluation of the effectiveness of the design and operation of our
disclosure controls and procedures (as defined in Securities Exchange Act Rule 13a-15(e)) as of the
end of the quarterly period covered by this Quarterly Report and identified a deficiency, discussed
below, that it considered to be material weaknesses in the effectiveness of our internal controls
over financial reporting related to accounting for certain outstanding stock options and warrants.
Pursuant to standards established by the Public Company Accounting Oversight Board, a material
weakness is a deficiency, or combination of deficiencies, in internal control over financial
reporting, such that there is a reasonable possibility that a material misstatement of the
companys annual or interim financial statements will not be prevented or detected on a timely
basis.
For the period ended June 30, 2011, we originally reported as current liabilities the fair
value of stock options modified and of warrants potentially settleable in cash of $682,000 and
$11,882,000, respectively, as determined using the Black-Scholes option-pricing model based on
erroneous weighted-average stock volatility of 74.52%. The correct weighted-average stock
volatility for this purpose was 98.63%. The non-cash charge associated with the warrant liability
contributed to our originally reported net loss of $1,382,000 and $5,227,000 for the three and six
months ended June 30, 2011, respectively. We recently restated our condensed consolidated financial
statements as of June 30, 2011 by means of an amended Quarterly Report for the period ended June
30, 2011 to reflect corrected current liabilities of $1,036,000 and $14,254,000 attributable to the
fair value of options modified and of warrants potentially settleable in cash, respectively. Our
restated condensed consolidated financial statements also reflect associated other income of
$871,000 and $2,306,000 and a net loss of $3,754,000 and $7,599,000 for the three months and six
months ended June 30, 2011, respectively. The adjustment to the fair value of the stock options
modified liability
23
Table of Contents
is accounted for as a reclassification of additional paid-in capital and had no
impact on the Companys other income and net loss.
The deficiency that management considered to be material weaknesses in the effectiveness of
our internal controls over our accounting for stock options modified and our warrants potentially
settleable in cash related to the miscalculation of the weighted-average volatility used in the
application of the Black-Scholes option-pricing model. In populating the spreadsheet for the
weighted-average volatilities of the four companies in the peer group identified by management,
management inadvertently omitted the volatility of one peer company. As a result, the
weighted-average volatility (computed by dividing by four the sum of the volatilities of the peer
companies) omitted one of the four volatilities, which led to the lower reported weighted-average
volatility. Having completed our review and evaluation of the calculation of the weighted-average
volatility and the application of the Black-Scholes option-pricing model, we believe that this
weakness has been remedied. We intend to closely monitor the peer group of companies utilized for
this purpose on an ongoing basis and additionally intend to enhance our internal review of the fair
values of our stock options and warrants to ensure the effectiveness of all aspects of our controls
related to stock options and warrants.
Based on his evaluation of the effectiveness of the design and operation of our disclosure
controls and procedures, because of the error described above, our President, Chief Executive
Officer and Chief Financial Officer has concluded that our disclosure controls and procedures over
our accounting for stock options modified and for warrants potentially settleable in cash were not
effective as of the end of the quarter ended September 30, 2011.
We continuously seek to improve and strengthen our control processes to ensure that all of our
controls and procedures are adequate and effective. Any failure to implement and maintain
improvements in the controls over our financial reporting could cause us to fail to meet our
reporting obligations under the Securities and Exchange Commissions rules and regulations. Any
failure to improve our internal controls to address the weakness we have identified could also
cause investors to lose confidence in our reported financial information, which could have a
negative impact on the trading price of our common stock.
Galena Biopharma, Inc.
PART II OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
None.
ITEM 1.A RISK FACTORS
You should consider the following risks associated with the spin-off of RXi, as well
as the Risk Factors included under Item 1A. of our annual report on Form 10-K for the year ended
December 31, 2010.
We Have Agreed to Undertake the Spin-Off of RXi, but May Not Be Able To Do So
We have agreed in the securities purchase with RXi and the investors in RXi to undertake to
distribute to our stockholders, on a share-for-share basis, shares of RXi common stock constituting
approximately 8% of the fully-diluted shares of RXi common stock at the time of the spin-off. The
spin-off of RXi is subject to SEC rules and the requirements of the Delaware General Corporation
Law, and we may be unable to comply with these rules and requirements, or may experience delays in
complying. The distribution of the spin-off shares also is expected to be taxable to our
stockholders.
We Retain Little Discretion Over RXis Use of its Funds
Although RXi currently is a wholly-owned subsidiary of ours, our $1.5 million capital
contribution to RXi and all funds received by RXi from the investors in RXi must be used for RXis
own working capital and general corporate purposes, including the payment of salaries and employee
expenses of its officers and other employees, and for other costs and expenses of its RNAi research
and development activities, by RXi in accordance with an operating budget approved by the
investors. We will have little discretion over RXis use of its funds, and will not be able to use
such funds in Galenas activities.
24
Table of Contents
We Have Agreed to Guarantee the Bridge Loan to RXi, and if the Spin-Off of RXi is Not Complete We
Will Lose Control of RXi
Pursuant to the securities purchase agreement, the investors have agreed to provide a Bridge
Loan to RXi by purchasing $500,000 of RXi convertible notes and agreeing to purchase up to an
additional $1 million of RXi convertible notes prior to closing. The RXi convertible notes accrue
interest at a rate of 7% per annum (or 18% per annum in the case of an event of default) and mature
on February 22, 2012, or earlier in the case of an event of default. The obligations due under the
RXi convertible notes are secured by a first-priority blanket lien on the assets of RXi and are
guaranteed by Galena. Additionally, Galena has pledged all of the shares of RXi common stock that
it holds to further guaranty the timely repayment of the amounts due under the RXi convertible
notes, if not converted into RXi Preferred Stock at closing.
If the closing of the transactions under the securities purchase agreement has not occurred by
the February 22, 2012 maturity date of the RXi convertible notes, then 50% of the outstanding
Bridge Loan balance will be converted into a number of shares of RXi common stock equal to 51% of
the post-conversion shares outstanding. RXi will remain obligated to repay the remaining balance of
the principal and accrued interest under the Bridge Loan, and Galena has agreed to guarantee RXis
repayment of the RXi convertible notes to the extent they are not converted. In this event, Galena
and Advirna will beneficially own 44% and 5%, respectively, of the outstanding shares of RXi common
stock, and RXi will carry on as a stand-alone private company under the investors control. Neither
the investors nor Galena will be obliged to provide any funding to RXi in this event.
Risks Associated With Our Ownership of RXi
If the spin-off is completed, or if it is not completed and we become a minority stockholder
in RXi, the value of our ownership interest in RXi will depend upon RXis success in developing and
commercializing products based upon its RNAi technologies, which is subject to significant risks
and uncertainties, including the risks and uncertainties described in RXis Registration Statement
on Form S-1 filed on October 25, 2011 with the SEC.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. REMOVED AND RESERVED
ITEM 5. OTHER INFORMATION
None.
6. EXHIBITS
EXHIBIT INDEX
Exhibit | ||
Number | Description | |
10.1
|
Separation and Transition Agreement entered into as of September 24, 2011 between Galena Biopharma, Inc. (formerly RXi Pharmaceuticals Corporation) and Pamela Pavco, Ph.D.* | |
10.2
|
Amendment No. 1 to Employment Agreement made as of September 23, 2011 between Galena Biopharma, Inc. (formerly RXi Pharmaceuticals Corporation) and Mark W. Schwartz, Ph.D.* |
25
Table of Contents
10.3
|
Employment letter dated 21 September 2011 between Galena Biopharma, Inc. (formerly RXi Pharmaceuticals Corporation) and Kwang Lee.* | |
31.1
|
Sarbanes-Oxley Act Section 302 Certification of Chief Executive Officer and Chief Financial Officer. | |
32.1
|
Sarbanes-Oxley Act Section 906 Certification of Chief Executive Officer and Chief Financial Officer. | |
101
|
The following financial information from the Quarterly Report on Form 10-Q of Galena Biopharma, Inc. for the quarter ended September 30, 2011, formatted in XBRL (eXtensible Business Reporting Language): (1) Condensed Consolidated Balance Sheets as of September 30, 2011 and December 31, 2010; (2) Condensed Consolidated Statements of Expenses for the three months and Nine months ended September 30, 2011 and 2010 and for the period from January 1, 2003 (inception) to September 30, 2011; (3) Condensed Consolidated Statements of Cash Flows for the Nine months ended September 30, 2011 and 2010 and for the cumulative period from January 1, 2003 (inception) to September 30, 2011; and (4) Notes to Condensed Consolidated Financial Statements (Unaudited).** |
* | Indicates a management contract or compensatory plan or arrangement. | |
** | In accordance with Rule 406T of Regulation S-T, the XBRL-related information in Exhibit 101 to this Quarterly Report on Form 10-Q is deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 and 12 of the Securities Act, is deemed not filed for purposes of Section 18 of the Exchange Act, and otherwise is not subject to liability under these sections, is not part of any registration statement or prospectus to which it relates and is not incorporated by reference into any registration statement, prospectus or other document. |
26
Table of Contents
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly
caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
Galena Biopharma, Inc. (Registrant) |
||||
By: | /s/ Mark J. Ahn | |||
Mark J. Ahn | ||||
President, Chief Executive Officer and Chief Financial Officer Date: November 14, 2011 |
||||
27