Conference call to be held today at 4:30 p.m.
Eastern time
Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology
company focused on the discovery, development and commercialization
of immunotherapy products, today announces financial results for
the three months ended January 31, 2018 and provides a business
update.
Recent Key Accomplishments Include:
- Conditional Marketing Authorization
Application (MAA) submission to the European Medicines Agency (EMA)
for the company’s lead Lm Technology product candidate,
axalimogene filolisbac, for the treatment of adult women who
progress beyond first-line therapy of persistent, recurrent or
metastatic carcinoma of the cervix (PRmCC);
- Acceptance of data for publication from
a Phase 2 clinical study of axalimogene filolisbac as a treatment
for PRmCC in the peer-reviewed International Journal of
Gynecological Cancer;
- Three abstracts highlighting the
company’s Listeria-based immunotherapy in combination with
antibody-based immunotherapies have been accepted for poster
presentation at the upcoming 2018 Keystone Symposia on Cancer
Immunotherapies: Combinations (C5);
- Publication of data from an
investigator-initiated study of axalimogene filolisbac in
combination with chemoradiation as a treatment for high-risk,
locally advanced anal cancer in the International Journal of
Radiation Oncology; and
- $20.0 million in gross proceeds raised
in a public offering of common stock.
Clinical Hold
In the evening of March 9, 2018, the company received
notification from the U.S. Food and Drug Administration (FDA) that
its Investigational New Drug (IND) application for its Phase 1/2
combination study of axalimogene filolisbac with IMFINZI
(durvalumab) for the treatment of patients with advanced, recurrent
or refractory human papillomavirus (HPV)-associated cervical cancer
and HPV-associated head and neck cancer was placed on clinical
hold. The clinical hold pertains to a recent submission of a safety
report to the FDA regarding a Grade 5 Serious Adverse Event
(patient death) on February 27, 2018 involving respiratory failure
which occurred following the sixth combination cycle in the trial.
Enrollment and further dosing are on hold in this trial while the
company, its partner and the FDA work closely with the site
investigator to review this event in detail and to resolve this
clinical hold.
Enrollment and dosing in all other Advaxis clinical programs are
unaffected at this time.
“We care deeply for our patients and for their safety as we work
to research and develop new treatment options for advanced cancers.
We believe in the potential of our Lm Technology to provide new
advancements in the area of cancer care,” stated Anthony Lombardo,
interim Chief Executive Officer of Advaxis. “We are confident in
the safety and efficacy profile of axalimogene filolisbac, to date,
based on our experience in over 250 patients and over 700 doses
across multiple trials in HPV-associated cancers.”
Management Commentary
“We are pleased with the progress we made during the quarter
across a number of important areas. In particular, we were
delighted to file the MAA with the EMA for conditional approval of
axalimogene filolisbac for the treatment of metastatic cervical
cancer, a condition that causes approximately 24,000 deaths
annually in Europe,” stated Mr. Lombardo. “This is a significant
milestone for Advaxis as it is our first marketing application for
an Lm Technology product.”
“Throughout the first quarter, we continued to advance our
clinical programs and were pleased to announce the publication and
presentation of data in support of the potential of our Lm-based
antigen delivery platform to treat a variety of cancers in
peer-reviewed journals and at premier medical and scientific
meetings.
“Our goals for 2018 remain steadfast as we execute our plans to
advance our robust clinical development programs across our four
franchises: HPV-associated cancers, neoantigen therapy, hotspot/
cancer antigens and prostate cancer. Over the coming months, we
expect to make meaningful progress with these programs and to
achieve a number of important value-creating milestones,” Mr.
Lombardo concluded.
Balance Sheet Highlights
As of January 31, 2018, Advaxis had cash, cash equivalents and
investments of $59.4 million, which included $4.5 million related
to its previously announced participation in the New Jersey NOL
program and the receipt of $2.7 million in connection with its
controlled equity offering sales agreement. The company used
approximately $12.7 million in cash to fund operations during the
first quarter of fiscal year 2018, mainly attributed to funding
strategic development programs and related personnel and
infrastructure to support the company’s progress and growth.
Following the close of the first quarter, Advaxis completed an
underwritten public offering of 10,000,000 shares of common stock
at $2.00 per share for gross proceeds of $20.0 million before
deducting the underwriting discounts and commissions and other
estimated offering expenses.
Throughout fiscal year 2018, Advaxis plans to continue to invest
in its core clinical programs and expects its current cash position
will be sufficient to fund its business plan into the second
calendar quarter of 2019.
Financial Highlights for First Quarter Fiscal Year
2018
The net loss for the first quarter ended January 31, 2018 was
$20.5 million or $0.49 per share based on 41.4 million shares
outstanding. This compares with a net loss for the first quarter of
fiscal year 2017 of $17.1 million or $0.43 per share based on 40.1
million shares outstanding.
Research and development expenses for the first quarter of
fiscal year 2018 were $17.1 million, compared with $13.6 million
for the first quarter of fiscal year 2016. The increase was
primarily due to continued investment in support of the company’s
preclinical and clinical development programs, including support of
the AIM2CERV Phase 3 clinical trial and costs associated with the
MAA filing, which are now expected to wind down, post-submission.
The increase also reflects higher headcount versus the first
quarter of fiscal 2017, to support research and development
initiatives primarily for the neoantigen franchises.
General and administrative expenses for the first quarter of
fiscal year 2018 were $5.5 million, compared with $7.3 million for
the fiscal year 2017 first quarter. The decrease was largely
attributable to non-cash stock-based compensation expense in the
prior-year quarter.
Conference Call and Webcast Information
Advaxis’ senior management will host a conference call to review
financial results, provide a business update and answer questions.
The conference call and live audio webcast will begin today at 4:30
p.m. Eastern time.
To access the conference call please dial (844) 348-6133
(domestic) or (631) 485-4564 (international) and refer to
conference ID 2588455. A live and archived audio webcast of the
call will be available on the company’s website at
ir.advaxis.com/events-presentations.
For those unable to participate in the live conference call or
webcast, a recording will be available beginning two hours after
the call ends. To access the recording, dial (855) 859-2056 or
(404) 537-3406 and provide conference ID 2588455.
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
This press release contains forward-looking statements,
including, but not limited to, statements regarding Advaxis’
ability to develop and commercialize the next generation of cancer
immunotherapies, and the safety and efficacy of Advaxis’
proprietary immunotherapies. These forward-looking statements are
subject to a number of risks including the risk factors set forth
from time to time in Advaxis’ SEC filings including, but not
limited to, its report on Form 10-K for the fiscal year ended
October 31, 2017, and on Form 10-Q for the quarter ended January
31, 2018, which are available at www.sec.gov.
Any forward-looking statements set forth in this presentation
speak only as of the date of this presentation. We do not intend to
update any of these forward-looking statements to reflect events or
circumstances that occur after the date hereof other than as
required by law. You are cautioned not to place undue reliance on
any forward-looking statements.
IMFINZI is a registered trademark of AstraZeneca AB
Corporation.
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version on businesswire.com: http://www.businesswire.com/news/home/20180312006137/en/
Company:Advaxis, Inc.Noelle Heber, 609-250-7575Sr.
Director Corporate Communications and Government
AffairsHeber@advaxis.comorMedia:Stern Strategy GroupBrian
Hyland, 908-325-3891Bhyland@sternstrategy.comorRachel Auerbach,
908-325-3898Rauerbach@sternstrategy.comorInvestors:LHA
Investor RelationsAnne Marie Fields,
212-838-3777afields@lhai.com
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