Annual cash burn will be reduced to
approximately $50 million from approximately $80 million through a
combination of portfolio rationalization and headcount
reduction
Conference call begins today at 11:00 a.m.
Eastern time
Advaxis, Inc. (NASDAQ: ADXS), a late-stage biotechnology
company focused on the discovery, development and commercialization
of immunotherapy products, today announced a new prioritization of
its product portfolio, as well as financial results and business
highlights for the three months ended April 30, 2018.
The product portfolio review was conducted under the leadership
of recently appointed President and CEO Ken Berlin, along with the
full Advaxis executive team including recently named Chief Medical
Officer Andres Gutierrez, M.D., Ph.D. The process reflects a
commitment to allocate capital to programs that meet three
criteria: (i) commercially attractive applications for the
company’s Lm technology platform, (ii) the opportunity for the Lm
platform to meaningfully impact cancer care, and (iii) a rapid and
cost-effective route to generate clinical and immunological
response data to demonstrate proof of concept. Each portfolio
program was reviewed to determine whether Advaxis can create more
value by developing the program internally or externally.
Advaxis has decided to reduce internal investment in axalimogene
filolisbac (AXAL) and will seek partnership opportunities for AXAL
in most human papillomavirus (HPV)-associated cancers, including
cervical cancer. If the company is unable to secure a partner
within a limited period of time, Advaxis will wind down the ongoing
AIM2CERV trial in high-risk locally advanced cervical cancer, and
will not conduct the ADVANCE PD-1 combination trial in metastatic
cervical cancer, which has not yet been initiated. Advaxis has
determined to focus future development efforts for AXAL on
HPV-positive head-and-neck cancer through cost-effective clinical
studies that are currently being explored.
Data were presented on the ADXS-PSA combination trial with
KEYTRUDA® on June 2nd at ASCO 2018. These data, while early, have
proven worthy of further evaluation and the company will continue
to follow patients for the next six to nine months in order to
determine the path forward.
Advaxis has also decided to increase internal investment in the
ADXS-NEO and ADXS-HOT programs, both of which target neoantigens, a
potentially transformational, next-generation approach to treating
cancer.
Both the ADXS-NEO and the ADXS-HOT programs aim to instruct T
cells to selectively attack neoantigens and, in the case of
ADXS-HOT, against other tumor-associated antigens, with the goal of
controlling tumor growth and prolonging life. Advaxis’ proprietary
Lm platform uniquely positions the company in the development of
advanced T cell therapeutics compared with other approaches. This
belief is based on, among other things, data derived from more than
530 patients treated with AXAL and other product candidates,
showing a manageable safety profile, induction of immune responses
and clinical activity.
Clinical Hold Update
In March 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 AXAL
with durvalumab for the treatment of patients with advanced,
recurrent or refractory HPV-associated cervical cancer and
HPV-associated head-and-neck cancer was placed on clinical hold due
to the death of a trial subject that involved pulmonary toxicity
occurring after nine months of therapy.
As announced at the time, Advaxis began working closely with the
site investigator, its partner AstraZeneca and the FDA to review
this event in detail and to resolve this clinical hold. Several
external experts from prominent institutions were also consulted in
the process.
Advaxis plans to submit a response to the FDA shortly, and
expects to receive a response from the Agency within 30 days after
the submission.
Management Commentary
“Everything we are striving to accomplish depends on focus and
optimal allocation of resources, and is designed to maximize
shareholder value. We are dedicating more resources to the HOT
program because these assets scored very high when we conducted our
portfolio review,” said Mr. Berlin. “This program, along with our
NEO program which is partnered with Amgen, hold great potential in
the exciting and fast-developing field of neoantigens and have
application across multiple tumor types in high-value indications.
Therefore, it is important for us to allocate increased resources
to realize the potential of these programs and to allow for more
rapid advancement in this competitive field.”
“Our new approach is based on a simple reality: While we are
fortunate to have a robust product pipeline, we cannot continue to
pursue all programs with our current level of resources. We
continue to believe in HPV as a target, and are evaluating
cost-effective studies for AXAL in head-and-neck cancer. We hope to
secure a partner to continue the development of AXAL in cervical
cancer,” he added.
“In addition, we are pleased to have completed the buildout of
our executive leadership team with yesterday’s announcement that
Molly Henderson has joined Advaxis as Executive Vice President and
Chief Financial Officer,” he continued. “Coupled with the addition
of Executive Vice President and Chief Medical Officer Dr. Andres
Gutierrez, we now have the team in place to drive the company
forward.”
Corporate Restructuring and Impact on Operating
Expenses
As part of the change in strategic direction, Advaxis will
implement a reduction in force, effective today, to align staffing
levels with development priorities. The workforce reduction
involves the elimination of approximately 24% of the company’s
workforce. Advaxis will take a one-time charge in the fiscal third
quarter related to this restructuring of approximately $905,000.
The elimination of these positions in conjunction with reductions
in clinical expenditures will significantly lower operating
expenses, allowing the company to focus on priority programs.
Reflecting the product portfolio prioritization and workforce
reduction, Advaxis expects that its annual cash burn will be
approximately $50 million, down 38% from its prior annual cash burn
of approximately $80 million.
Financial Highlights for Second Quarter Fiscal Year
2018
The net loss for the second quarter ended April 30, 2018 was
$13.4 million or $0.27 per share based on 49.9 million shares
outstanding. This compares with a net loss for the second quarter
of fiscal year 2017 of $20.5 million or $0.51 per share based on
40.3 million shares outstanding.
Research and development expenses for the second quarter of
fiscal year 2018 were $10.8 million, compared with $16.3 million
for the second quarter of fiscal year 2017. The decrease is
primarily attributable to a decrease in laboratory costs, drug
manufacturing process validation and drug stability studies
supporting the MAA, which was filed in February 2018.
General and administrative expenses for the second quarter of
fiscal year 2018 were $4.5 million, compared with $7.8 million for
the second quarter of fiscal year 2017. The decrease was largely
attributable to the elimination of non-cash stock-based
compensation paid to consultants.
Balance Sheet Highlights
As of April 30, 2018, the company had $58.8 million in cash,
restricted cash, cash equivalents and short-term investment
securities on its balance sheet. The company has completed a
thorough analysis of operating expenses and its research and
development programs. As a result, the company has announced a
workforce reduction effective June 7, 2018, and is in the process
of making further cost-reduction decisions regarding select ongoing
clinical trials. Based upon these actions, the company believes its
cash position as of today is sufficient to fund operations for at
least one year.
Conference Call and Webcast Information
Advaxis’ senior management will host a conference call to review
the content of this news release and answer questions. The
conference call and live audio webcast will begin today at 11:00
a.m. Eastern time.
To access the conference call please dial (domestic) (844)
348-6133 or (631) 485-4564 (international) and refer to conference
ID 8975538. 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 digital recording will be available beginning two hours
after the conference call ends. To access the recording, dial (855)
859-2056 or (404) 537-3406 and provide the operator with the
conference ID: 8975538. In addition, the audio webcast will be
archived on the Company’s website for a period of time at
ir.advaxis.com/events-presentations.
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 patient accrual; our
ability to release the clinical hold and reduce the impact to our
trials; 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 ability of our product
candidates to successfully perform in clinical trials; our ability
to initiate trials, enroll our trials, obtain and maintain approval
of our product candidates; 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.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J.,
USA.
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version on businesswire.com: https://www.businesswire.com/news/home/20180607005281/en/
Investors:LHA Investor RelationsMiriam Weber Miller,
212-838-3777mmiller@lhai.comorAdvaxis,
Inc.Ranya Dajani, 609-250-7559dajani@advaxis.com
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