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Advaxis Reports Fiscal 2018 Third Quarter Business Highlights and Financial Results

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Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company
focused on the discovery, development and commercialization of
immunotherapy products, today announced business highlights and
financial results for the fiscal year 2018 third quarter, ended July 31,
2018.

Recent key accomplishments include:

  • Dosing of the first patient in the Company's Phase 1 trial with
    ADXS-NEO, a personalized immunotherapy approach targeting neoantigens
    identified by sequencing a patient's own cancer cells, partnered with
    Amgen.
  • U.S. Food and Drug Administration (FDA) allowance of the Company's
    Investigational New Drug (IND) application for its first ADXS-HOT drug
    candidate, ADXS-503, for non-small cell lung cancer. ADXS-HOT is an
    off-the-shelf cancer-type specific immunotherapy approach that
    leverages the Company's proprietary Lm technology platform to
    target hotspot mutations and other tumor-associated antigens that
    commonly occur in specific cancer types.
  • Selecting prostate and bladder cancers as the second and third
    ADXS-HOT drug candidates to take into the clinic.
  • Granting of a license to OS Therapies for the use of ADXS31-164, also
    known as ADXS-HER2, for evaluation in the treatment of osteosarcoma, a
    rare and aggressive tumor that forms in the bone.
  • Pricing of its public offering of common stock and warrants. The
    planned underwritten public offering is expected to result in gross
    proceeds of approximately $20 million and close on or around September
    11, 2018.

Management Commentary

"We are encouraged by the momentum achieved with both of our
neoantigen-focused programs during our third fiscal quarter and continue
on our path of achieving our goal of having five neoantigen-based
product candidates in clinical evaluation by the end of 2019," said
Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "We
believe in the powerful impact neoantigens may have on the cancer
treatment paradigm. Several of the unique attributes of our Lm platform
including the capacity of our vector to contain a large number of
neoantigens in each single drug construct, as well as the vector's
ability to generate strong T-cell responses to neoantigens as
demonstrated in previously reported studies, provide us with an
opportunity to lead in this potentially revolutionary field of cancer
treatment.

"ADXS-NEO, partnered with Amgen, takes a personalized approach to
therapy and has the potential to make an important contribution among
underserved cancer patient populations with few or no treatment
options," he added. "Similarly, the IND allowance by the FDA of our
ADXS-HOT drug candidate for non-small cell lung cancer enables us to
finalize our Phase 1 trial design and dose our first patient by the end
of the year. The ADXS-HOT program, in general, is focused on shared
hotspot mutations and other cancer antigens commonly found in cancers
with large patient populations such as non-small cell lung cancer and
prostate cancer."

"We are also excited about the licensing transaction executed with OS
Therapies to evaluate our HER-2 therapy for the treatment of human
osteosarcoma. This is a product candidate we believe in, although it
falls outside our neoantigen focus. The transaction supports continued
clinical development by a team of experts exclusively focused on finding
new treatments for osteosarcoma and allows us to remain dedicated to our
corporate strategy," he added.

Financial Results for Third Quarter Fiscal Year 2018

The net loss for the third quarter ended July 31, 2018 was $14.0 million
or $0.27 per share. This compares with a net loss for the third quarter
of fiscal year 2017 of $32.6 million or $0.80 per share. The $18.6
million reduction in the net loss compared to prior year was primarily a
result of the significant reduction in spending in research, development
and administrative areas.

Research and development expenses for the third quarter of fiscal year
2018 were $10.8 million, compared with $17.8 million for the third
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 we withdrew in July
2018.

General and administrative expenses for the third quarter of fiscal year
2018 were $4.5 million, compared with $18.0 million for the third
quarter of fiscal year 2017. The decrease is primarily attributable to a
decrease in stock-based compensation of approximately $11.4 million
related to the resignation of the Company's Chief Financial Officer and
Chief Executive Officer in April 2018 and July 2017, respectively, two
Board members who did not seek re-election in March 2018, a reduction in
headcount and the elimination of stock-based compensation paid to
consultants.

Balance Sheet Highlights

As of July 31, 2018, the Company had approximately $40.4 million in
cash, restricted cash and cash equivalents on its balance sheet. The
Company is anticipating closing on an underwritten public offering of
its common stock and warrants on or around September 11, 2018 which is
expected to result in gross proceeds of approximately $20 million to the
Company.

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 Statements

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
resolve any clinical holds 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.

 
Advaxis, Inc.
Selected Consolidated Balance Sheet Data
(Unaudited, in thousands)
 
 

July 31,
2018

   

October 31,
2017

Cash and cash equivalents $ 39,434 $ 23,900
Restricted cash $ 977 $ 587
Short-term investment securities $ - $ 46,398
Total assets $ 61,059 $ 93,642
Total stockholders' equity $ 33,331 $ 54,260
 
 
Advaxis, Inc.
Condensed Statements of Operations
(unaudited, in thousands, except per share information)
 
  Three Months Ended
July 31,
  Nine Months Ended
July 31,
2018   2017 2018   2017
 
Revenue $ 1,131 $ 3,052 $ 4,934 $ 10,268
 
Operating expenses *
Research and development expenses 10,800 17,794 38,703 47,750
General and administrative expenses   4,495   17,995   14,495 33,101
Total operating expenses   15,295   35,789   53,198 80,851
 
Loss from operations (14,164 ) (32,737 ) (48,264 ) (70,583 )
 
Other expense   147   112   397   459
Net loss before benefit for income taxes (14,017 ) (32,625 ) (47,867 ) (70,124 )
 
Income tax expense   -   -   50   50
 
Net loss $ (14,017 ) $ (32,625 ) $ (47,917 ) $ (70,174 )
 
Net loss per common share, basic and diluted $ (0.27 ) $ (0.80 ) $ (1.00 ) $ (1.74 )
 
Weighted average number of common shares outstanding, basic and
diluted
  52,668,919   40,609,794 47,966,672   40,315,356
 
* Includes stock-based compensation as follows
Research and development $ 543 $ 1,517 $ 2,342 $ 4,271
General and administrative   1,409   12,853   3,645   20,423
 
$ 1,952 $ 14,370 $ 5,987 $ 24,694
 

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