Advaxis Reports Second Quarter Fiscal 2019 Financial Results and Provides Pipeline Update

Conference call to be held June 11 at 11:00 a.m. ET

PRINCETON, N.J.–(BUSINESS WIRE)–Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company
focused on the discovery, development and commercialization of
immunotherapy products, today announced an update on its clinical
pipeline and financial results for the fiscal second quarter ended April
30, 2019.

Key updates on the progress of the company’s clinical pipeline include
the following:

• ADXS-NEO: Personalized,
  Neoantigen-Directed Therapy – The company is currently
  enrolling patients in its Phase 1 dose-escalation study to evaluate
  ADXS-NEO, a personalized neoantigen-directed immunotherapy designed to
  activate a patient’s immune system in a range of cancers. The company
  presented safety, tolerability and immune correlative data from this
  study at the American Association of Cancer Research (“AACR”) Annual
  Meeting in March, and updated findings were presented at the Frontiers
  in Cancer Immunotherapy Conference at the New York Academy of Sciences
  (“NYAS”) in May. The study’s preliminary data demonstrated anti-tumor
  immune activation, including T-cell responses to neoantigens and
  antigen spreading, within one week after the first dose. In addition,
  data from two microsatellite-stable (“MSS”) colorectal cancer patients
  dosed with ADXS-NEO at 1×10⁸ CFU demonstrated
  increased CD8+ T-cell infiltration in the tumor microenvironment after
  three doses of ADXS-NEO. Metastatic MSS colorectal cancer is
  considered to be a “cold” tumor type and typically exhibits little
  CD8+ T-cell infiltration and resistance to immunotherapy, yet both MSS
  patients had their “cold” tumors successfully transition into “hot”
  tumors with ADXS-NEO therapy. Further, two patients (one treated at
  1×10⁹ and one at 1×10⁸ CFU) achieved stable
  disease in the study per RECIST 1.1 criteria.
• ADXS-HOT: Cancer Type-Focused
  Hotspot/Off-the-Shelf Neoantigen-Directed Therapies –
  ADXS-HOT is a program consisting of over 10 different cancer-type
  specific immunotherapy constructs, which target hotspot mutations,
  cancer testis antigens and oncofetal antigens. The first drug
  candidate from this program, ADXS-503, is designed to treat most types
  of non-small cell lung cancer and is in a Phase 1/2 clinical trial.
  One site is currently activated and enrolling patients with a second
  site anticipated to be activated by the end of June. The study will
  determine the recommended dose, safety, tolerability and immune and
  clinical activity of ADXS-503 administered alone and in combination
  with a checkpoint inhibitor. Preliminary data from this Phase 1/2
  study are anticipated in the second half of 2019. The company plans to
  file INDs on two additional HOT constructs within the next nine months.
• ADXS-PSA: Prostate Cancer –
  The company presented updated clinical and biomarker data at the AACR
  Annual Meeting in April on its Phase 1/2 KEYNOTE-046 study of
  ADXS-PSA, alone and in combination with KEYTRUDA^®, Merck’s
  anti-PD-1 therapy, for patients with metastatic castration-resistant
  prostate cancer (“mCRPC”). In addition, updated findings presented at
  the Frontiers in Cancer Immunotherapy Conference at the NYAS in May
  demonstrated clinical activity and prolonged overall survival in MSS
  mCRPC patients, who typically are not expected to respond to treatment
  of a checkpoint inhibitor.
• ADXS-HPV: Cervical Cancer –
  In May, the U.S. Food and Drug Administration (“FDA”) lifted its
  partial clinical hold on the Phase 3 AIM2CERV study evaluating
  ADXS-HPV (“AXAL”) for the treatment of patients with high-risk,
  locally advanced cervical cancer. The company is in discussions with
  the FDA to allow for an earlier interim analysis for efficacy under
  proposed revisions to the AIM2CERV protocol.

Management Commentary

“We are very encouraged by the early and promising data from our first
neoantigen-directed immunotherapy, ADXS-NEO,” said Kenneth A. Berlin,
President and Chief Executive Officer of Advaxis. “Based on these
results, we continue to believe neoantigen-directed immunotherapies can
become an important addition to the cancer treatment paradigm due to the
unique presentation of neoantigens in cancer cells. The results from our
ADXS-NEO program have shown the ability to have an impact within the
tumor microenvironment in metastatic colorectal cancer, which
historically has been a tumor type that is refractory to immunotherapy.
We look forward to starting Part B of the study with ADXS-NEO in
combination with a checkpoint inhibitor in the third quarter of this
year.”

“We have used the valuable insight we have gained from our ADXS-NEO
platform to further advance our ADXS-HOT drug constructs. We are in
discussions with a leading academic institution to finalize an
investigator-sponsored trial evaluating ADXS-HOT in patients with
prostate cancer, and anticipate the IND for this construct will be filed
later this year.” He added, “In order to ensure we have the appropriate
resources to fund our programs, we have taken cost-control measures over
the past year. These efforts have resulted in a reduction to our cash
burn of more than 50% for the first six months of fiscal year 2019
versus the comparable period last year.” He concluded, “We are actively
reviewing our plans to finance the areas of the business where we feel
there is a strong likelihood of us achieving our mission of improving
the lives of people with cancer and their loved ones.”

Fiscal Second Quarter Financial Results

Research and development expenses for the second quarter of fiscal year
2019 were $6.0 million, compared with $10.4 million for the second
quarter of fiscal year 2018. The $4.4 million decrease was primarily
attributable to cost controls initiated in the second half of fiscal
year 2018. In addition, there was a decrease in clinical trial expenses
resulting from the partial clinical hold on AIM2CERV and the winding
down of several older studies, partially offset by an increase in
expenses related to the startup costs associated with the commencement
of the Phase 1/2 ADXS-HOT clinical trial.

General and administrative expenses for the second quarter of fiscal
year 2019 decreased 37% to $3.1 million from $4.9 million for the second
quarter of fiscal year 2018. The $1.8 million decrease was primarily
attributable to a reduction in headcount and in professional and
consulting fees related to external strategy and program assessment work
performed in fiscal 2018.

Revenue decreased approximately $0.5 million to $1.2 million for the
second quarter of fiscal 2019 from $1.7 million for the second quarter
of 2018 due to the termination of the collaboration agreement with Amgen
effective February 2019. Net loss for the second quarter of fiscal year
2019 was $9.4 million or $1.59 per share, compared with a net loss for
the second quarter of fiscal year 2018 of $13.4 million or $4.03 per
share.

Net cash used during the six months ended April 30, 2019 was $11.4
million. As of April 30, 2019, Advaxis had cash and cash equivalents of
$33.7 million, which includes $9.0 million in net proceeds from a public
offering completed in April.

Conference Call

The company will host a business update call on Tuesday, June 11, 2019
at 11:00 a.m. ET. During the call, Advaxis’ senior management will
review the company’s clinical development programs and fiscal second
quarter financial results, and provide a general business update.

The conference call and live audio webcast information is as follows:

WHEN: Tuesday, June 11, 2019 at 11:00 a.m. ET
DOMESTIC DIAL-IN:
(844) 348-6133
INTERNATIONAL DIAL-IN: (631) 485-4564
CONFERENCE
ID: 6199489
WEBCAST: ir.advaxis.com/events-presentations

For those unable to participate in the live conference call or webcast,
a digital recording will be available beginning June 11, 2019 two hours
after the completion of the call. To access the recording, please dial
(855) 859-2056 (domestic) or (404) 537-3406 (international) and provide
the operator with the conference ID: 6199489. In addition, an audio
webcast will be archived on the Company’s website for a period of time
at www.advaxis.com.

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 T cells to eliminate
tumors. Advaxis has four programs in various stages of clinical
development: ADXS-NEO, a personalized neoantigen-directed therapy in
principle for any solid tumor; ADXS-503 for non-small cell lung cancer,
from its ADXS-HOT off-the-shelf neoantigen-directed program, ADXS-PSA
for prostate cancer and ADXS-HPV for cervical 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, including to support current and planned clinical
activities; 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; our 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.

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a
subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA.

[Financial tables follow]

Advaxis, Inc.
Selected Balance Sheet Data
(In thousands)
				April 30,
				2019					October 31,
				(Unaudited)					2018
Cash and cash equivalents				$	33,706				$	44,141
Restricted cash				$	–				$	977
Total assets				$	49,771				$	62,267
Total stockholders’ equity				$	43,170				$	24,051

STATEMENTS OF OPERATIONS
(unaudited, in thousands, except share and per share data)
				Three Months Ended April 30,								Six Months Ended April 30,
				2019				2018				2019				2018
Revenue				$	1,188			$	1,747			$	20,877			$	3,803
Operating expenses *
Research and development expenses					5,969				10,368				12,675				27,119
General and administrative expenses					3,092				4,932				5,759				10,785
Total operating expenses					9,061				15,300				18,434				37,904
(Loss) income from operations					(7,873	)			(13,553	)			2,443				(34,101	)
Interest income, net					113				151				259				291
Net changes in fair value of derivative liabilities					(14	)			–				2,395				–
Loss on shares issued in settlement of warrants					(1,607	)			–				(1,607	)			–
Other expense					(2	)			(6	)			(56	)			(90	)
Net (loss) income				$	(9,383	)		$	(13,408	)		$	3,434			$	(33,900	)
Net (loss) income per common share
Basic				$	(1.59	)		$	(4.03	)		$	0.65			$	(11.16	)
Diluted				$	(1.59	)		$	(4.03	)		$	0.20			$	(11.16	)
Weighted average number of common shares outstanding
Basic					5,900,449				3,324,320				5,259,677				3,038,439
Diluted					5,900,449				3,324,320				5,282,772				3,038,439
* Includes stock-based compensation as follows:
Research and development				$	258			$	526			$	581			$	1,799
General and administrative					221				699				520				2,235
				$	479			$	1,225			$	1,101			$	4,034

Contacts

Investors:
LHA Investor Relations
Yvonne Briggs, (310) 691-7100
[email protected]