- Completed enrollment in the NeuVax Phase 3 PRESENT
breast cancer immunotherapy clinical trial
- Commercial programs continue on track
- Abstral® (fentanyl) Sublingual Tablets achieve net
revenue of $2.8 million; full year 2015 net revenue guidance
reiterated at $15-$18 million
- Zuplenz® (ondansetron) Oral Soluble Film product launch
targeted for July
- Webcast and conference call scheduled for today at 2:00
p.m. P.T. / 5:00 p.m. E.T.
Galena Biopharma, Inc. (Nasdaq:GALE), a biopharmaceutical company
developing and commercializing innovative, targeted oncology
therapeutics that address major medical needs across the full
spectrum of cancer care, today reported its financial results for
the quarter ended March 31, 2015 and provided a business
update.
"We achieved two critical milestones thus far this year with
completion of enrollment in our Phase 3 PRESENT trial and the
closing of a public offering to solidify our balance sheet," said
Mark W. Schwartz, Ph.D., President and Chief Executive Officer.
"Together, these events demonstrate Galena's near-term and
longer-range value proposition as we continue to advance the
Company's development and commercial operations to capitalize on
significant treatment opportunities within the oncology
setting."
Dr. Schwartz continued, "Completing enrollment and
over-enrolling our PRESENT trial is a major accomplishment for
Galena. We are now focused on treating and monitoring the 758
patients in this Phase 3 trial as we progress towards our
event-driven, interim analysis at the end of this year or in the
first quarter of 2016. The ongoing advancement of our NeuVax and
GALE-301 programs showcase the significant potential of our cancer
immunotherapy programs that are designed to harness the power of
the immune system to prevent a patient's cancer from returning. To
do this effectively, we are treating women in the adjuvant setting
whose immune systems have returned to a healthy status after having
received their cancer treatments, giving NeuVax and GALE-301 the
best opportunity to make a difference."
Dr. Schwartz concluded, "Dovetailing the clinical successes
during the quarter, the financing that we secured in March was an
important achievement for Galena as it provides us the flexibility
to advance our development programs and to strengthen our
commercial efforts. Our immunotherapy platform has multiple
clinical trials ongoing and we look forward to key data readouts
from these trials over the next year. Meanwhile, on the commercial
front, Abstral sales remain on target, our oncology presence
continues to grow, and we reiterate our full year guidance of
$15-$18 million for 2015. Additionally, we are now preparing to
launch Zuplenz in July, adding a second, supportive care commercial
product to our oncology-focused sales portfolio. In total, we have
established a strong foundation with our development programs
supported by our commercial franchise, and we remain committed to
the growth of our company."
Galena will host a webcast and conference call today at 2:00
p.m. P.T./5:00 p.m. E.T. to discuss financial and business results.
The live webcast will include slides that can be accessed on
the Company's website under the Investors section/Events and
Presentations: http://investors.galenabiopharma.com/events.cfm. The
conference call can be accessed by dialing (844) 825-4413 toll-free
in the U.S., or (973) 638-3403 for participants outside the U.S.
The Conference ID number is: 33786642. The archived webcast
replay will be available on the Company's website for 90
days.
FINANCIAL HIGHLIGHTS AND GUIDANCE
We recognize revenue from the sale of Abstral to wholesale
pharmaceutical distributors, net of product-related discounts,
allowances, product returns, rebates, chargebacks, and patient
assistance benefits, as applicable. Net revenue was $2.8
million in the first quarter of 2015, a 28% increase compared to
$2.2 million for the same period a year ago.
Operating loss for the first quarter of 2015 was $11.1 million,
including $0.6 million in stock based compensation, compared to an
operating loss of $11.8 million, including $1.7 million in
stock-based compensation for the same period in 2014. The decrease
in net operating loss year-over-year is primarily the result of the
completion of enrollment in our Phase 3 PRESENT trial for NeuVax,
as well as the decrease in stock based compensation.
Other income or expenses include non-cash charges related to
changes in the fair value estimates of the company's warrant
liabilities and contingent purchase price liability, and the
realized gain from the sale of marketable securities. The
non-cash benefit related to the changes in the value of our warrant
liability for the first quarter of 2015 was $1.2 million for the
three months ended March 31, 2015, versus a non-cash benefit of
$9.8 million for the same period in 2014, respectively.
Net loss for the first quarter of 2015 was $10.5 million,
including $1.2 million in a non-cash benefit described above, or
$0.08 per basic and diluted share. Net loss for the first quarter
of 2014 was $2.5 million, including a $9.8 million non-cash benefit
described above, or $0.02 per basic and diluted share.
On March 18, 2015, we announced the closing of our underwritten
public offering of 24,358,974 shares of common stock and 12,179,487
warrants to purchase our common stock at an exercise price of
$2.08. The underwriters also exercised their over-allotment option
to purchase warrants to purchase an aggregate of 1,826,923 shares
of our common stock. On April 10, 2015 the underwriters exercised
their option to purchase an additional 3,653,846 shares of common
stock for additional net proceeds of $5.4 million. The total net
proceeds to us from the March 2015 offering were approximately
$40.8 million. Also, during January and February of 2015 we
raised $6.6 million under the Lincoln Park and ATM agreements,
resulting in a total cash raise of $47.4 million during the first
quarter of 2015 and through today.
As of March 31, 2015, Galena had cash and cash equivalents of
$52.9 million, compared with $23.7 million as of December 31,
2014. The $29.2 million increase in cash during the first
quarter represents the aforementioned cash raised from issuance of
common stock (excluding the April overallotment exercise),
partially offset by $11.6 million used in operating activities,
$0.5 million milestone payment for Zuplenz, and $0.9 million in
debt service payments.
FIRST QUARTER AND RECENT HIGHLIGHTS
NeuVax™ (nelipepimut-S) achieves critical milestone with
completion of over-enrollment in its Phase 3 PRESENT (Prevention of
Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to
Intermediate HER2 Expression with NeuVax Treatment)
clinical trial. NeuVax is a first-in-class,
HER2-directed cancer immunotherapy under evaluation to prevent
cancer recurrence after standard of care treatment in the adjuvant
setting in breast and gastric cancers. Galena over-enrolled
the trial by 7.7% with a total of 758 patients now in the
intent-to-treat (ITT) population. The protocol for the PRESENT
trial, being conducted under an FDA approved Special Protocol
Assessment (SPA), called for 700 patients; and, the Company expects
this higher number of ITT patients will increase the confidence in
the timing, the statistics and the final outcome of the trial. The
primary endpoint is currently expected to be reached in 2018, after
the last patient dosed reaches her 36th month of follow-up, or a
total of 141 events (recurrence or death) occur, whichever comes
later. PRESENT is a randomized, double blind, placebo
controlled, international, Phase 3 trial and is being conducted in
13 countries at more than 140 sites.
Expanded the patient population in the Phase 2 clinical
trial with NeuVax in combination with trastuzumab in HER2 1+/2+
patients to include Human Leukocyte Antigen (HLA) A24 or A26
Positive Patients. The trial evaluates node
positive, triple negative, and high-risk node negative breast
cancer patients with immunohistochemistry (IHC) HER2 1+/2+
expressing tumors who are disease-free after standard of care
therapy. To date, NeuVax has been tested in trials with
patients who are HLA-A2+ or A3+, representing more
than 60% of the North American, European and Chinese
populations. NeuVax has also been shown to bind to HLA-A24 and
A26, which represents an additional 10-15% of the population in the
U.S., but more importantly, represents up to approximately 70% of
the population in Japan.
CORPORATE HIGHLIGHTS
Hired Joseph Lasaga as Vice President, Business
Development and Alliance Management. Mr. Lasaga
brings more than 17 years of experience in the biotechnology and
pharmaceutical industry in the areas of research and development,
business development, alliance management and
product strategy. Prior to joining Galena, Mr. Lasaga
spent four years at Nektar Therapeutics, most recently as Senior
Director, Business Development where he led the successful
execution of several transactions for the company and managed
several key partnerships. Between 1998-2010, Mr. Lasaga
worked at Rigel Pharmaceuticals where he led and participated
in many buy-side and sell-side asset transactions
adding significant value to the organization during his
tenure there. Mr. Lasaga received his Masters of
Business Administration in Marketing from San Francisco State
University and his Bachelor of Science in Molecular Biology with a
minor in Chemistry from San Jose State University.
Enhanced the balance sheet with the closing of a public
offering of common stock, receiving gross proceeds of $43.7
million. With the closing of the over-allotment,
total net proceeds to Galena from the offering were approximately
$40.8 million, after deducting underwriting discounts and
commissions and estimated offering expenses payable by
Galena. Galena intends to use the net
proceeds from the offering to fund its operations, including the
ongoing commercialization of Abstral® (fentanyl) Sublingual Tablets
and Zuplenz® (ondansetron) Oral Soluble Film, its ongoing Phase 3
PRESENT study and other clinical trials of its product candidates,
and for other working capital and general corporate purposes.
|
|
|
GALENA BIOPHARMA,
INC. |
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS |
(unaudited) |
(Amounts in thousands,
except share and per share data) |
|
|
|
|
Three Months
Ended March 31, |
|
2015 |
2014 |
Net revenue |
$ 2,750 |
$ 2,173 |
Costs and expenses: |
|
|
Cost of revenue (excluding
amortization of certain acquired intangible assets) |
393 |
331 |
Research and development |
5,910 |
6,770 |
Selling, general, and
administrative |
7,427 |
6,830 |
Amortization of certain
acquired intangible assets |
146 |
91 |
Total costs and expenses |
13,876 |
14,022 |
Operating loss |
(11,126) |
(11,849) |
Non-operating income (expense): |
|
|
Change in fair value of
warrants potentially settleable in cash |
1,152 |
9,792 |
Interest expense, net |
(242) |
(314) |
Other expense |
(321) |
(165) |
Total non-operating income,
net |
589 |
9,313 |
Net loss |
$ (10,537) |
$ (2,536) |
Net loss per common share: |
|
|
Basic and diluted net loss per
share |
$ (0.08) |
$ (0.02) |
Weighted average common shares outstanding:
basic and diluted |
136,054,864 |
116,244,209 |
|
|
|
|
|
|
GALENA BIOPHARMA,
INC. |
CONDENSED CONSOLIDATED
BALANCE SHEETS |
(unaudited) |
(Amounts in
thousands) |
|
|
|
|
March 31, 2015 |
December 31, 2014
(1) |
ASSETS |
|
|
Current assets: |
|
|
Cash and cash equivalents |
$ 52,860 |
$ 23,650 |
Restricted cash |
200 |
200 |
Accounts receivable |
1,060 |
1,839 |
Inventory |
637 |
655 |
Prepaid expenses and other
current assets |
2,564 |
2,680 |
Total current assets |
57,321 |
29,024 |
Equipment and furnishings, net |
528 |
555 |
In-process research and development |
12,864 |
12,864 |
Abstral rights |
14,387 |
14,533 |
Zuplenz Rights |
8,101 |
8,101 |
GALE-401 rights |
9,255 |
9,255 |
Goodwill |
6,069 |
6,069 |
Deposits |
82 |
87 |
Total assets |
$ 108,607 |
$ 80,488 |
LIABILITIES AND STOCKHOLDERS'
EQUITY |
|
|
Current liabilities: |
|
|
Accounts payable |
$ 3,293 |
$ 2,271 |
Accrued expense and other
current liabilities |
12,149 |
15,669 |
Fair value of warrants
potentially settleable in cash |
14,528 |
5,383 |
Current portion of long-term
debt |
3,994 |
3,910 |
Total current liabilities |
33,964 |
27,233 |
Deferred tax liability, non-current |
5,053 |
5,053 |
Contingent purchase price consideration, net
of current portion |
6,972 |
6,651 |
Long-term debt, net of current portion |
3,534 |
4,492 |
Total liabilities |
49,523 |
43,429 |
Stockholders' equity: |
59,084 |
37,059 |
Total liabilities and
stockholders' equity |
108,607 |
80,488 |
|
|
|
(1) Derived from the audited
consolidated financial statements as of December 31, 2014. |
|
|
|
About Galena Biopharma
Galena Biopharma, Inc. (Nasdaq:GALE) is a biopharmaceutical
company developing and commercializing innovative, targeted
oncology therapeutics that address major medical needs across the
full spectrum of cancer care. Galena's development
portfolio ranges from mid- to late-stage clinical assets, including
a robust immunotherapy program led by NeuVax™ (nelipepimut-S)
currently in an international, Phase 3 clinical trial. The
Company's commercial drugs include Abstral® (fentanyl) Sublingual
Tablets and Zuplenz® (ondansetron) Oral Soluble Film. Collectively,
Galena's clinical and commercial strategy focuses on identifying
and advancing therapeutic opportunities to improve cancer
care, from direct treatment of the disease to the reduction of
its debilitating side-effects. For more information visit
www.galenabiopharma.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Such statements include, but are not limited to,
statements about our 2014 revenue from the sale of Abstral®, our
planned launch of Zuplenz®, the issuance of patents, and the
progress of development of Galena's product candidates, including
patient enrollment in our clinical trials. These forward-looking
statements are subject to a number of risks, uncertainties and
assumptions, including those identified under "Risk Factors" in
Galena's Annual Report on Form 10-K for the year ended December 31,
2014 and most recent Quarterly Reports on Form 10-Q filed with the
SEC. Actual results may differ materially from those
contemplated by these forward-looking statements. Galena does not
undertake to update any of these forward-looking statements to
reflect a change in its views or events or circumstances that occur
after the date of this press release.
NeuVax™ and Abstral® are trademarks of Galena Biopharma, Inc.
All other trademarks are the property of their respective
owners.
CONTACT: Remy Bernarda
SVP, Investor Relations & Corporate Communications
(503) 405-8258
rbernarda@galenabiopharma.com
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