Get Cash Back and $0 Commissions
+ The Power of TradeStation
Business Wire 9-Sep-2019 8:00 AM
Advaxis, Inc. (NASDAQ:ADXS), a clinical-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 third quarter ended July 31, 2019.
Key corporate and clinical pipeline updates include:
Management Commentary
"We believe the data generated from our ADXS-NEO program has provided valuable immunological insight that will be applicable across our neoantigen programs," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "Specifically, we are increasingly excited by the potential of our investigational ADXS-HOT program to provide a rapidly available, off-the-shelf immunotherapy to patients and believe that the generation of CD8+ T cells against hotspot mutations in the NEO program serves as an important proof-of-mechanism for this approach. In addition, we are thrilled to see consistent antigen spreading across our programs which is an important driver of clinical response."
Mr. Berlin continued, "We have continued our efforts to reduce cash burn and increase efficiencies, and with our improved cash position we will continue to focus our efforts on those programs most likely to improve patient outcomes and create shareholder value. We look forward to providing a more detailed pipeline update next month with important details relevant to the advancement of our innovative immunotherapy clinical programs."
Fiscal Third Quarter Ended July 31, 2019 Financial Results
Research and development expenses for the third quarter of fiscal year 2019 were $7.1 million, compared with $10.6 million for the third quarter of fiscal year 2018. The decrease is largely attributable to the wind down of its Phase 3 clinical trial in high-risk, locally advanced cervical cancer, as announced in June 2019.
General and administrative expenses for the three months ended July 31, 2019 decreased approximately $1.7 million, or 35%, compared to the same three-month period in 2018. In June 2018, the Company began instituting measures to control costs for non-essential items in areas that do not support the strategic direction of the company. The decrease in expenses in these areas is a direct result of these cost control measures.
As of July 31, 2019, the Company had approximately $41.8 million in cash and cash equivalents. The Company believes this is sufficient capital to fund its obligations, as they become due, in the ordinary course of business until at least September 2020.
About Advaxis, Inc.
Advaxis, Inc. is a clinical-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 three programs in various stages of clinical development: ADXS-NEO, a personalized neoantigen-directed therapy designed, in principle, for any solid tumor; ADXS-503 for non-small cell lung cancer, from its ADXS-HOT off-the-shelf neoantigen-directed program and ADXS-PSA for prostate cancer.
To learn more about Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook and YouTube.
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are any statements that express the current beliefs and expectations of management, including but not limited to statements related to the expected use of proceeds from the proposed offering. These and other risks are discussed in the Company's filings with the SEC, including, without limitation, its Annual Report on Form 10-K, filed on January 11, 2019, and its periodic reports on Form 10-Q and Form 8-K, as well as the risks identified in the registration statement and the preliminary prospectus supplement relating to the offering. Any statements contained herein that do not describe historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results, performance and achievements to differ materially from those discussed in such forward-looking statements. The Company cautions readers not to place undue reliance on any forward-looking statements, which speak only as of the date they were made. The Company undertakes no obligation to update or revise forward-looking statements, except as otherwise required by law, whether as a result of new information, future events or otherwise.
Advaxis, Inc. |
||||||||
Selected Balance Sheet Data |
||||||||
(In thousands) |
||||||||
|
||||||||
July 31, |
|
|
|
|||||
2019 |
|
|
October 31, |
|||||
(Unaudited) |
|
|
2018 |
|||||
Cash and cash equivalents |
$ |
41,755 |
|
$ |
44,141 |
|||
Restricted cash |
$ |
- |
|
$ |
977 |
|||
Total assets |
$ |
56,133 |
|
$ |
62,267 |
|||
Total stockholders' equity |
$ |
49,269 |
|
$ |
24,051 |
|||
STATEMENTS OF OPERATIONS |
|||||||||||||||||
(unaudited, in thousands, except share and per share data) |
|||||||||||||||||
|
|
Three Months Ended July 31, |
|
|
Nine Months Ended July 31, |
|
|||||||||||
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
|||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Revenue |
|
$ |
6 |
|
|
$ |
1,131 |
|
|
$ |
20,883 |
|
|
$ |
4,934 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses* |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses |
|
|
7,060 |
|
|
|
10,560 |
|
|
|
19,735 |
|
|
|
37,679 |
|
|
General and administrative expenses |
|
|
3,076 |
|
|
|
4,735 |
|
|
|
8,834 |
|
|
|
15,519 |
|
|
Total operating expenses |
|
|
10,136 |
|
|
|
15,295 |
|
|
|
28,569 |
|
|
|
53,198 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(10,130 |
) |
|
|
(14,164 |
) |
|
|
(7,686 |
) |
|
|
(48,264 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income, net |
|
|
95 |
|
|
|
149 |
|
|
|
354 |
|
|
|
439 |
|
|
Net changes in fair value of derivative liabilities |
|
|
177 |
|
|
|
- |
|
|
|
2,572 |
|
|
|
- |
|
|
Loss on shares issued in settlement of warrants |
|
|
- |
|
|
|
- |
|
|
|
(1,607 |
) |
|
|
- |
|
|
Income tax expense and other expense |
|
|
- |
|
|
|
(2 |
) |
|
|
(57 |
) |
|
|
(92 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(9,858 |
) |
|
$ |
(14,017 |
) |
|
$ |
(6,424 |
) |
|
$ |
(47,917 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share, basic and diluted |
|
$ |
(1.00 |
) |
|
$ |
(3.99 |
) |
|
$ |
(0.94 |
) |
|
$ |
(14.98 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares outstanding, basic and diluted |
|
|
9,870,461 |
|
|
|
3,511,261 |
|
|
|
6,813,494 |
|
|
|
3,197,778 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* Includes stock-based compensation as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
241 |
|
|
$ |
543 |
|
|
$ |
822 |
|
|
$ |
2,342 |
|
|
General and administrative |
|
|
223 |
|
|
|
1,409 |
|
|
|
743 |
|
|
|
3,645 |
|
|
|
|
$ |
464 |
|
|
$ |
1,952 |
|
|
$ |
1,565 |
|
|
$ |
5,987 |
|
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20190909005275/en/