Conference call to be held June 11 at 11:00
a.m. ET
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 1x108 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
1x109 and one at 1x108 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. ETDOMESTIC DIAL-IN:
(844) 348-6133INTERNATIONAL DIAL-IN: (631) 485-4564CONFERENCE ID:
6199489WEBCAST: 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 EndedApril
30, Six Months EndedApril 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
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version on businesswire.com: https://www.businesswire.com/news/home/20190610005704/en/
Investors:LHA Investor RelationsYvonne Briggs, (310)
691-7100ybriggs@lhai.com
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