Conference call to be held December 21st at
10:00 a.m. Eastern time
Advaxis, Inc. (NASDAQ:ADXS), a late-stage
biotechnology company focused on the discovery, development and
commercialization of immunotherapy products, today provides a
business update and announces its financial results for the fiscal
year ended October 31, 2017.
Key 2017 Accomplishments
- Re-prioritization of the Company’s
clinical programs to focus on four key areas: HPV-associated
cancers, neoantigen therapy, disease focused hotspot and cancer
antigen therapies and prostate cancer;
- Progress in the HPV-related cancer
franchise, with important milestones including the initiation of
patient dosing in Advaxis’ Phase 3 study, AIM2CERV and presentation
of the ground-breaking GOG-0265 data;
- FDA acceptance of the IND for
ADXS-NEO;
- Presentation of initial immunological
and clinical data from the monotherapy arm of the ongoing Phase 1/2
study in prostate cancer at multiple medical meetings; and
- New clinical partnerships with
Bristol-Myers Squibb and Sellas Life Sciences.
Management Commentary
“2017 was a year of change for Advaxis as we evolved into a more
focused and disciplined enterprise, and we have made significant
progress with our clinical programs,” stated Anthony Lombardo,
interim Chief Executive Officer of Advaxis. “We’re fortunate that
as immuno-oncology continues to evolve, the flexibility of our
proprietary Lm Technology platform allows Advaxis to
continue to adapt and introduce highly innovative programs.”
“We refined our clinical strategy to concentrate on four
distinct franchises and conducted a thorough review of the business
with the entire Advaxis team to implement tactics to enhance value.
We are confident that this diversification strategy holds
significant potential to create shareholder value while developing
much-needed targeted cancer therapies for patients in need.
“As we move into our fiscal 2018, our focus will be on executing
our strategy while driving additional efficiencies throughout the
organization. We expect to achieve a number of value-creating
milestones that will position Advaxis for continued growth and
expansion throughout the year and beyond. Our management team is
committed to delivering for our shareholders and unlocking the full
potential of our Lm Technology platform,” Mr. Lombardo
concluded.
Balance Sheet Highlights
As of October 31, 2017, Advaxis had cash, cash equivalents and
investments of $70.9 million. The Company used approximately $76.9
million in cash to fund operations during fiscal 2017, 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 fiscal year, the Company reported
approval for a $4.8 million tax credit from the NJEDA’s NOL
program. The Company expects to receive $4.5 million in cash by the
end of their fiscal Q1 2018.
In 2017 the Company completed an in-depth review of all spend
and has eliminated programs that were not supportive of its
strategic goals. Due to this increased discipline, the Company has
returned to the historical quarterly burn rate of approximately $20
million in the fourth quarter of 2017, excluding partnership
reimbursement and other cash receivables. Moving into 2018, the
Company will continue to be disciplined and expects its cash burn
to decrease from its 2017 level, as there were several one-time
costs in 2017 related to preparation for the regulatory filing of
axalimogene filolisbac in Europe and related infrastructure costs,
which are not anticipated to recur.
Throughout fiscal 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 fiscal 2019.
Financial Highlights for Fiscal Year 2017
The net loss for the fiscal year ended October 31, 2017 was
$93.4 million or $2.31 per share based on 40.5 million shares
outstanding. This compares with a net loss for fiscal 2016 of $73.6
million or $2.08 per share based on 35.4 million shares
outstanding.
Research and development expenses for fiscal 2017 were $71.9
million, compared with $48.8 million for fiscal 2016. The $23.1
million increase was primarily a result of continued investment in
support of the Company’s preclinical and clinical development
programs. In addition, the Company had higher third-party costs
related to its HPV franchise primarily supporting the AIM2CERV
Phase 3 clinical program, preparations for the planned EU
submission for conditional approval, start-up activities related to
the ADXS-DUAL program and ADXS-PSA Phase 1/2 trial support. The
increase also reflects higher headcount to support the research and
development initiatives.
General and administrative expenses for fiscal 2017 were $38.7
million, compared with $31.7 million for fiscal 2016. The increase
was largely attributable to non-cash stock-based compensation
expense, which increased by $6.7 million year-over-year. The
Company expects G&A expenses in the near term to remain
comparable to current levels, exclusive of the impact of non-cash
stock awards and one-time expenses.
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 at 10:00 a.m.
Eastern time on Thursday, December 21, 2017.
To access the conference call please dial (844) 348-6133
(domestic) or (631) 485-4564 (international) and refer to
conference ID 4682169. A live and archived audio webcast of the
call will be available on the Company’s website at
www.ir.advaxis.com/news-events.
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 4682169.
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
mutation therapy 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, 2016, which is 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20171220006059/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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