Advaxis Reports Fiscal Year 2018 Financial Results and Provides a Business Update

Conference call to be held Tuesday, January 15, 2019 at 11am ET

PRINCETON, N.J.–(BUSINESS WIRE)–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
 

Contacts

Investors:
LHA Investor Relations
Miriam Weber Miller,
(212) 838-3777
mmiller@lhai.com