Conference call to be held Tuesday, January 15,
2019 at 11am ET
Advaxis, Inc. (NASDAQ: ADXS) (the Company), a late-stage
biotechnology company focused on the discovery, development and
commercialization of immunotherapy products, today announces its
financial results for the fiscal year ended October 31, 2018 and
provides a business update.
Fiscal Year 2018 and Recent Key Accomplishments
- Received U.S. Food and Drug
Administration allowance of the Investigational New Drug
application for the Company’s first ADXS-HOT off-the-shelf
neoantigen drug candidate, ADXS-503, for the treatment of all types
of non-small cell lung cancer;
- Dosed the first patients in the
ADXS-NEO Phase 1 dose-escalation study in patients with several
solid tumor types;
- Raised gross proceeds totaling
approximately $40 million from an underwritten public offering of
common stock and an underwritten public offering of common stock
and warrants;
- Appointed a permanent chief executive
officer, Kenneth A. Berlin, a new chief medical officer, Andres
Gutierrez, M.D., and a new chief financial officer, Molly
Henderson;
- Licensed ADXS-HER2 to OS Therapies for
evaluation in the treatment of pediatric osteosarcoma;
- Significantly reduced annual net cash
usage through a prioritization of programs and assets; and
- Presented and published data from
several preclinical and clinical trials with the Company’s drug
candidates.
Management Commentary
“Fiscal 2018 was an eventful year for Advaxis as we worked to
reorganize the company, prioritize our pipeline and define a
strategic direction that supports our mission to improve the lives
of people suffering from cancer and their loved ones,” said Kenneth
A. Berlin, president and chief executive officer of Advaxis. “Our
diverse pipeline of drug candidates and constructs at various
stages of development is based on our proprietary Lm platform,
which has a significant safety database from first-generation
constructs already tested in humans.”
Mr. Berlin added, “We are dosing patients under our ADXS-NEO
program and anticipate the first patient to be enrolled in our
ADXS-503 study within the next several weeks. These are significant
accomplishments for the Company and we’re excited to start to see
early correlative and safety data from these neoantigen programs
during the first half of 2019.”
Mr. Berlin continued, “During the second half of fiscal year
2018 we took steps to significantly reduce our cash burn and align
our spending in keeping with a company our size. We are committed
to advancing our various clinical programs as rapidly and cost
effectively as possible throughout fiscal year 2019. We also
continue to evaluate opportunities for partnerships and
collaborations across all of our programs, and anticipate several
catalysts for the Company in 2019. We remain committed to
demonstrating that the drug candidates emanating from our Lm
platform have the potential to positively impact people with
cancer,” Mr. Berlin concluded.
Balance Sheet Highlights
As of October 31, 2018, Advaxis had cash and cash equivalents of
$44.1 million. The Company used $62.1 million in cash to fund
operations during fiscal 2018, mainly attributed to funding
research and development and general and administrative activities.
Throughout fiscal 2018, the Company completed an in-depth review of
all programs and cash expenditures, and reduced its net annual cash
usage to approximately $50 million.
Fiscal Year 2018 Financial Information
Research and development expenses for fiscal 2018 were $57.0
million, compared with $70.5 million for fiscal 2017. The
$13.5 million decrease was primarily attributable to a decrease in
laboratory costs, drug manufacturing process validation and drug
stability studies.
General and administrative expenses for fiscal 2018 were $19.5
million, compared with $40.0 million for fiscal 2017. The $20.5
million decrease was primarily attributable to an $18.0 million
decrease in stock-based compensation expense.
The net loss for the fiscal year ended October 31, 2018 was
$66.5 million or $1.29 per share based on 51.5 million weighted
average shares outstanding. This compares with a net loss for
fiscal 2017 of $93.4 million or $2.31 per share based on 40.5
million weighted average shares outstanding.
Conference Call and Webcast Information
Advaxis’ senior management will host a conference call to review
financial results, provide a business update and answer questions
at 11:00 a.m. Eastern time on Tuesday, January 15, 2019.
To access the conference call please dial (844) 348-6133 for
domestic callers or (631) 485-4564 for international
callers. A live and archived audio webcast of the call will
be available on the Company’s website at
www.ir.advaxis.com/news-events.
A recording will be available beginning two hours after the call
ends by dialing (855) 859-2056 for domestic callers or (404)
537-3406 for international callers and providing conference ID
4862946.
About Advaxis, Inc.
Advaxis, Inc. is a late-stage biotechnology company focused on
the discovery, development and commercialization of
proprietary Lm-based antigen delivery products. These
immunotherapies are based on a platform technology that utilizes
live attenuated Listeria monocytogenes (Lm) bioengineered to
secrete antigen/adjuvant fusion proteins. These Lm-based
strains are believed to be a significant advancement in
immunotherapy as they integrate multiple functions into a single
immunotherapy and are designed to access and direct antigen
presenting cells to stimulate anti-tumor T cell immunity, activate
the immune system with the equivalent of multiple adjuvants, and
simultaneously reduce tumor protection in the tumor
microenvironment to enable the T cells to eliminate tumors. Advaxis
has four franchises in various stages of clinical and preclinical
development: HPV-associated cancers, neoantigen therapy,
hotspot/cancer antigens and prostate cancer.
To learn more about Advaxis, visit www.advaxis.com and connect
on Twitter, LinkedIn, Facebook and YouTube.
Advaxis Forward-Looking Statement
Some of the statements included in this press release may be
forward-looking statements that involve a number of risks and
uncertainties. For those statements, we claim the protection of the
safe harbor for forward-looking statements contained in the Private
Securities Litigation Reform Act of 1995. The factors that could
cause our actual results to differ materially include: the success
and timing of our clinical trials, including subject accrual; our
ability to avoid any clinical holds; our ability to obtain and
maintain regulatory approval and/or reimbursement of our product
candidates for marketing; our ability to obtain the appropriate
labeling of our products under any regulatory approval; our plans
to develop and commercialize our products; the successful
development and implementation of our sales and marketing
campaigns; the size and growth of the potential markets for our
product candidates and our ability to serve those markets; our
ability to successfully compete in the potential markets for our
product candidates, if commercialized; regulatory developments in
the United States and other countries; the rate and degree of
market acceptance of any of our product candidates; new products,
product candidates or new uses for existing products or
technologies introduced or announced by our competitors and the
timing of these introductions or announcements; market conditions
in the pharmaceutical and biotechnology sectors; our available
cash; the accuracy of our estimates regarding expenses, future
revenues, capital requirements and needs for additional financing;
our ability to obtain additional funding; our ability to obtain and
maintain intellectual property protection for our product
candidates; the success and timing of our preclinical studies
including IND-enabling studies; the timing of our IND submissions,
the ability to get FDA approval for study amendments, the timing of
data read-outs, the ability of our product candidates to
successfully perform in clinical trials; our ability to initiate,
enroll, and execute pilots and clinical trials; our ability to
maintain collaborations; our ability to manufacture and the
performance of third-party manufacturers; the performance of our
clinical research organizations, clinical trial sponsors and
clinical trial investigators; our ability to successfully implement
our strategy; and other risk factors identified from time to time
in our reports filed with the SEC. Any forward-looking
statements set forth in this press release speak only as of the
date of this press release. We do not intend to update any of these
forward-looking statements to reflect events or circumstances that
occur after the date hereof.
Advaxis, Inc. Selected Balance Sheet Data
(In thousands) October 31, 2018
October 31, (Unaudited) 2017 Cash and cash equivalents $ 44,141 $
23,900 Restricted cash $ 977 $ 587 Short-term investment securities
$ - $ 46,398 Total assets $ 62,267 $ 93,642 Total stockholders’
equity $ 24,051 $ 54,260
Advaxis, Inc.
Statements of Operations (In thousands, except per share
information) Years Ended October 31, 2018
2017 (Unaudited) Revenue $ 6,063 $ 12,031
Operating expenses * Research and development expenses 56,970
70,508 General and administrative expenses 19,472 39,969
Total operating expenses 76,442 110,477 Loss from
operations (70,379 ) (98,446 ) Net changes in fair value of
derivative liabilities 3,400 20 Other expense 514 588
Net loss before benefit for income taxes (66,465 ) (97,838 )
Income tax expense (benefit) 50 (4,403 ) Net
loss $ (66,515 ) $ (93.435 ) Net loss per common share,
basic and diluted $ (1.29 ) $ (2.31 ) Weighted average
number of common shares outstanding, basic and diluted 51,522,361
40,527,844 * Includes stock-based compensation as
follows Research and development $ 2,836 $ 5,648 General and
administrative 4,147 22,188 $ 6,983 $ 27,836
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190110005709/en/
Investors:LHA Investor RelationsMiriam Weber Miller,
(212) 838-3777mmiller@lhai.com
Ayala Pharmaceuticals (QX) (USOTC:ADXS)
Historical Stock Chart
From Mar 2024 to Apr 2024
Ayala Pharmaceuticals (QX) (USOTC:ADXS)
Historical Stock Chart
From Apr 2023 to Apr 2024