- Abstral net revenue was $2.2 million in Q1 2014, with full year
guidance of $11 to $15 million for 2014.
- Progress on clinical milestones for 2014 on track: completing
enrollment in the Phase 3 PRESENT trial, initiating the Phase 2
trial with GALE-401, and presenting Phase 1 data at ASCO and
completing Phase 2 enrollment for GALE-301.
Galena Biopharma (Nasdaq:GALE), a biopharmaceutical company
developing and commercializing innovative, targeted oncology
treatments that address major unmet medical needs to advance cancer
care, today reported its financial results for the quarter ended
March 31, 2014 and provided a business update.
"We are excited about our commercial progress with Abstral,
advancing our cancer immunotherapies NeuVax and GALE-301, and
completing the acquisition of GALE-401," said Mark J. Ahn, Ph.D.,
President and Chief Executive Officer. "2014 should be a
significant year of continued progress for Galena. We expect
Abstral sales to reach our guidance of $11 million to $15 million
in net revenue for the year. In pipeline development, we are
focused on our three major milestones of completing enrollment in
the Phase 3 PRESENT trial, initiating the Phase 2 trial with
GALE-401, and presenting GALE-301 Phase 1 data at ASCO and
completing Phase 2 enrollment."
Galena will host a conference call today at 2:00 p.m. P.T./5:00
pm E.T. to discuss financial and business results. The call can be
accessed by dialing (844) 825-4413 toll-free in the United States,
or (973) 638-3403 for participants outside the U.S. The Conference
ID number is: 33813249. The conference call will also be
webcast live and available under the Investors section/Events and
Presentations on the Company's website at www.galenabiopharma.com.
The archived webcast replay will be available on the Company's
website for 90 days.
First Quarter 2014 Financial Highlights
Galena Biopharma's first commercial product, Abstral® (fentanyl)
Sublingual Tablets, is approved for the treatment of breakthrough
cancer pain. Net revenue from the sale of Abstral for the
three months ended March 31, 2014 was $2.2 million, compared to no
net revenue for the three months ended March 31, 2013, and up from
$1.3 million in the fourth quarter of 2013. Cost of revenue
and gross margins were $0.3 million and $1.9 million, respectively,
for the three months ended March 31, 2014.
Operating loss for the three months ended March 31, 2014 was
$11.8 million, including $1.7 million in stock-based compensation
charges, compared with an operating loss of $6.6 million for the
three months ended March 31, 2013, including $0.4 million in
stock-based compensation charges, and an operating loss of $12.4
million for the fourth quarter of 2013, including $1.6 million in
stock-based compensation charges.
Galena Biopharma also incurs income or expense due to non-cash
charges related to changes in the fair value estimates of the
Company's warrant liabilities. Non-cash income related to the
change in warrant values was $9.8 million for the three months
ended March 31, 2014, compared to a non-cash loss of $5.0 million
for the three months ended March 31, 2013, and a non-cash loss of
$36.9 million for the fourth quarter of 2013.
Net loss for the three months ended March 31, 2014 was $2.5
million, or $0.02 per basic and diluted share, versus a net loss of
$9.3 million, or $0.11 per basic and diluted share, for the three
months ended March 31, 2013, and a net loss of $48.5 million, or
$0.46 per basic and diluted share, for the fourth quarter of
2013.
As of March 31, 2014, Galena had cash and cash equivalents of
$52.4 million, compared with $47.8 million as of December 31,
2013.
2014 Company Milestones
- Launched Galena Patient Services (GPS), a
full-service support program designed to enhance patient access to
commercial products, like Abstral, offered by the Company. A
dedicated GPS team works with healthcare professionals, patients,
and insurance providers to guide the benefits approval process and
make prescribing and receiving Galena Biopharma commercial products
as simple and as accessible as possible. All
GPS services are coordinated by a contracted third party vendor,
and all patient records are kept confidential to maintain HIPAA
(Health Insurance Portability and Accountability Act) privacy
standards.
- NeuVax™ (nelipepimut-S) clinical trials advance to seek
to prevent recurrence in breast cancer patients rendered
disease-free after completing standard of care therapy.
- Phase 3 PRESENT (Prevention of Recurrence in Early-Stage,
Node-Positive Breast Cancer with Low to Intermediate HER2
Expression with NeuVax™ Treatment) trial continues to enroll at
approximately 130 sites globally under an FDA-approved Special
Protocol Assessment with enrollment expected to complete in 2014.
- Phase 2b combination trial with Herceptin® (trastuzumab), in
collaboration with Genentech/Roche and the Henry M. Jackson
Foundation, is currently enrolling at 16 sites in the U.S. The
Phase 2b is a randomized, 300 patient trial enrolling node positive
and high-risk node negative HER2 1+/2+ patients seeking to prevent
breast cancer recurrence.
- Received Department of Defense (DoD) funding for a new clinical
trial with NeuVax in combination with Herceptin to prevent breast
cancer recurrence in neoadjuvant, high-risk HER2 3+ patients who
fail to obtain a pathological complete response (pCR). The
multi-center, prospective, randomized, single-blinded Phase 2 trial
is expected to begin in 2014.
- Announced a strategic development and commercialization
partnership for NeuVax with Dr. Reddy's Laboratories, Ltd. in
India. Under terms of the agreement, Galena licensed commercial
rights to Dr. Reddy's for NeuVax in breast and gastric cancers in
India, and Dr. Reddy's will lead the Phase 2 clinical trial of
NeuVax in gastric cancer, significantly expanding the potential
addressable patient population.
- Expanded Intellectual Property for NeuVax with a Notice of
Acceptance from the Australian Patent Office. The patent
affords protection for NeuVax, a HER2/neu peptide vaccine, for
inducing protective or therapeutic immunity to breast cancer
recurrence in patients having low-to-intermediate HER2 IHC ratings
of 1+ or 2+ and a FISH rating of less than 2.0 ± 20% for CYP17 to
HER2/neu gene expression ratio. The patent provides NeuVax the
exclusivity for this indication until 2028, not including any
patent term extensions.
- GALE-301 (Folate Binding Protein (FBP) vaccine)
advances into Phase 2 to prevent recurrences in high-risk ovarian
cancer patients after completing standard of care
therapy. Full Phase 1 results to be presented at the
American Society of Clinical Oncology (ASCO) 50th Annual Meeting,
May 30 - June 3, 2014.
- Acquired worldwide rights to anagrelide controlled
release, renamed GALE-401, to expand Galena's clinical development
pipeline into hematology. Galena expects to pursue the
expedited 505(b)(2) regulatory pathway to seek approval of GALE-401
for the treatment of essential thrombocythemia, or ET. GALE-401 is
expected to enter a Phase 2 trial in mid-year 2014.
- Strengthened corporate governance with the addition
of Irving M. Einhorn to serve as a member of the
Board of Directors and as a member of a special committee of
independent directors. Mr. Einhorn is the former
Regional Administrator of the Los Angeles Regional Office of the
Securities and Exchange Commission (SEC). Since leaving the
SEC, Mr. Einhorn has engaged in the private practice of law focused
exclusively on federal, state and self-regulatory organization
securities enforcement and securities compliance matters. Mr.
Einhorn has unique experience in SEC enforcement, SEC regulation,
SEC compliance, and SEC disclosure requirements based on 17 years
of service as an SEC attorney and more than 40 years of experience
as an attorney whose practice has been devoted exclusively to
securities related compliance and enforcement matters.
GALENA BIOPHARMA,
INC. |
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS |
(Amounts in thousands,
except share and per share data) |
(Unaudited) |
|
|
|
|
Three
Months Ended March 31, |
|
2014 |
2013 |
Net revenue |
$ 2,173 |
$ — |
Costs and expenses: |
|
|
Cost of revenue (excluding
amortization of certain acquired intangible assets) |
331 |
— |
Research and development |
6,770 |
5,081 |
Selling, general, and
administrative |
6,830 |
1,530 |
Amortization of certain
acquired intangible assets |
91 |
— |
Total costs and expenses |
14,022 |
6,611 |
Operating loss |
(11,849) |
(6,611) |
Non-operating income (expense): |
|
|
Change in fair value of
warrants potentially settleable in cash |
9,792 |
(5,003) |
Interest income (expense),
net |
(314) |
5 |
Other income (expense) |
(165) |
(446) |
Total non-operating income
(expense), net |
9,313 |
(5,444) |
Loss before income taxes |
(2,536) |
(12,055) |
Income tax benefit |
— |
2,762 |
Net loss |
$ (2,536) |
$ (9,293) |
Net loss per common share: |
|
|
Basic and diluted net loss per
share |
$ (0.02) |
$ (0.11) |
Weighted-average common shares outstanding:
basic and diluted |
116,244,209 |
83,002,323 |
|
|
|
GALENA BIOPHARMA,
INC. |
CONDENSED CONSOLIDATED
BALANCE SHEETS |
(Amounts in
thousands) |
|
|
|
|
March 31, 2014 |
|
|
(Unaudited) |
December 31,
2013 |
ASSETS |
|
|
Current assets: |
|
|
Cash and cash equivalents |
$ 52,427 |
$ 47,787 |
Restricted cash |
200 |
200 |
Accounts receivable |
1,466 |
3,683 |
Inventories |
358 |
386 |
Prepaid expenses |
1,328 |
1,399 |
Total current assets |
55,779 |
53,455 |
Equipment and furnishings, net |
653 |
665 |
In-process research and development |
12,864 |
12,864 |
Abstral rights, net |
14,882 |
14,979 |
GALE-401 rights |
2,110 |
— |
Goodwill |
5,898 |
5,898 |
Deposits and other assets |
104 |
115 |
Total assets |
$ 92,290 |
$ 87,976 |
LIABILITIES AND STOCKHOLDERS'
EQUITY |
|
|
Current liabilities: |
|
|
Accounts payable |
$ 1,574 |
$ 2,660 |
Accrued expenses and other
current liabilities |
9,793 |
8,667 |
Current maturities of capital
lease obligations |
6 |
6 |
Fair value of warrants
potentially settleable in cash |
12,365 |
48,965 |
Current portion of long-term
debt |
3,102 |
2,149 |
Total current liabilities |
26,840 |
62,447 |
Capital lease obligations, net of current
maturities |
23 |
26 |
Deferred tax liability |
5,053 |
5,053 |
Contingent purchase price consideration, net
of current portion |
6,987 |
6,821 |
Long-term debt, net of current portion |
6,883 |
7,743 |
Total liabilities |
45,786 |
82,090 |
Total stockholders' equity |
46,504 |
5,886 |
Total liabilities and
stockholders' equity |
$ 92,290 |
$ 87,976 |
|
|
|
About Abstral® (fentanyl) Sublingual
Tablets
Abstral® (fentanyl) Sublingual Tablets are an important
treatment option for inadequately controlled breakthrough cancer
pain which impacts 40%-80% of cancer patients. Abstral is approved
by the U.S. Food and Drug Administration, and is a sublingual
(under the tongue) fentanyl tablet indicated only for the
management of breakthrough pain in patients with cancer, 18 years
of age and older, who are already receiving, and who are tolerant
to, opioid therapy for their persistent baseline cancer pain. The
innovative Abstral formulation delivers the analgesic power and
increased bioavailability of micronized fentanyl in a convenient
sublingual tablet which is designed to dissolve under the tongue in
seconds, provide relief of breakthrough pain within minutes, and
match the duration of the pain episode. See full prescribing
information at www.abstral.com.
About NeuVax™ (nelipepimut-S)
NeuVax™ (nelipepimut-S) is the immunodominant nonapeptide
derived from the extracellular domain of the HER2 protein, a
well-established target for therapeutic intervention in breast
carcinoma. The nelipepimut-S sequence stimulates specific CD8+
cytotoxic T lymphocytes (CTLs) following binding to HLA-A2/A3
molecules on antigen presenting cells (APC). These activated
specific CTLs recognize, neutralize and destroy, through cell
lysis, HER2 expressing cancer cells, including occult cancer cells
and micrometastatic foci. The nelipepimut immune response can also
generate CTLs to other immunogenic peptides through inter- and
intra-antigenic epitope spreading. Based on a successful Phase 2
trial, which achieved its primary endpoint of disease-free survival
(DFS), the U.S. Food and Drug Administration (FDA) granted NeuVax a
Special Protocol Assessment (SPA) for its Phase 3 PRESENT
(Prevention of Recurrence in Early-Stage, Node-Positive Breast
Cancer with Low to Intermediate HER2 Expression with NeuVax
Treatment) study. The PRESENT trial is ongoing and additional
information on the study can be found at www.neuvax.com. A
randomized, multicenter investigator sponsored, 300 patient Phase
2b clinical trial is also enrolling patients to study NeuVax in
combination with Herceptin® (trastuzumab; Genentech/Roche).
About GALE-301 (Folate Binding Protein (FBP)
vaccine)
GALE-301 (Folate Binding Protein (FBP)) cancer immunotherapy
targets FBP, a well-validated therapeutic target, whichis highly
over-expressed in breast, ovarian and endometrial cancers. FBP is
the source of immunogenic peptides that can stimulate cytotoxic T
lymphocytes (CTLs) to recognize and destroy presenting
FBP-expressing cancer cells. The FBP vaccine consists of the
FBP peptide(s) combined with the immune adjuvant, granulocyte
macrophage-colony stimulating factor (GM-CSF). GALE-301 is
currently in a Phase 2 trial in ovarian cancer.
About GALE-401 (Anagrelide CR)
GALE-401 (Anagrelide CR) contains the active ingredient
anagrelide, an FDA-approved product, which has been in use since
the late 1990s for the treatment of Essential Thrombocythemia (ET).
GALE-401 is a reformulated, controlled release version of
anagrelide that is currently only given as an immediate release
(IR) version. Phase 1 studies have shown the drug to be effective
at lowering platelet levels while reducing side effects that
prevent patients from taking their therapy regularly. Adverse
events such as nausea, diarrhea, abdominal pain, palpitations,
tachycardia, and headache with anagrelide IR are dose and plasma
concentration dependent. Therefore, reducing the maximum
concentration (Cmax) is expected to reduce the side effects, but
preserve efficacy. GALE-401 has been shown to significantly
reduce the Cmax while preserving nearly 100% of the Area Under the
Curve (AUC), or the total amount of drug absorbed by the
body. Thus, GALE-401 is expected to reduce the peak plasma
exposure to lessen the adverse events while maintaining effective
therapeutic levels for platelet inhibition.
About Galena Biopharma
Galena Biopharma, Inc. (Nasdaq:GALE) is a Portland, Oregon-based
biopharmaceutical company developing and commercializing
innovative, targeted oncology treatments that address major unmet
medical needs to advance cancer care. 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 target revenue from the sale of Abstral®
and the progress of development of Galena's product candidates,
including patient enrollment in our clinical trials, as well as
statements about recent litigation and company and regulatory
investigations described in detail in Galena's Annual Report on
Form 10-K for the year ended December 31, 2013, the workings of the
recently formed special board committee and other expectations,
plans and prospects. 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, 2013 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.
CONTACT: Remy Bernarda
VP, Marketing & Communications
(503) 405-8258
rbernarda@galenabiopharma.com
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