Advaxis Reports Fiscal Year 2019 Financial Results and Provides a Business Update
Fiscal Year 2019 and Recent Key Accomplishments
- Completed enrollment in the first and second dose levels in Part A of the ongoing Phase 1/2 trial evaluating ADXS-503, the Company’s ADXS-HOT drug candidate in non-small cell lung cancer, with immune response data anticipated in early 2020.
- Completed manufacturing of ADXS-506, the Company’s ADXS-HOT drug candidate for bladder cancer, enabling future potential clinical development.
- Reported early immune response data from the Phase 1 ADXS-NEO study demonstrating the generation of CD8+ T cells against hotspot neoantigen mutations. These results serve as an important proof-of-mechanism for the Company’s off-the-shelf ADXS-HOT program which targets common hotspot mutations found in tumors.
- Announced updated overall survival from the KEYNOTE-046 Phase 1/2 trial evaluating ADXS-PSA in combination with KEYTRUDA® in metastatic castrate resistant prostate cancer. Median overall survival increased to 33.6 months from the previously reported 21.1 months.
- Entered collaborative research agreement with
University of California, Los Angeles to investigate anti-tumor immunity and responses generated by Lm vaccines targeting glioblastoma neoantigens. - Continued pipeline prioritization efforts enabling the reduction of operating expenses and extension of cash runway into early 2021.
Management Commentary
“Fiscal year 2019 has been marked with continued progress in the strategic advancement of our most promising clinical programs,” said
Balance Sheet Highlights
As of
Fiscal Year 2019 Financial Information
Research and development expenses for fiscal year 2019 were
General and administrative expenses for fiscal year 2019 were
The net loss for the fiscal year ended
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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 impact of the discontinuation on relationships related to the AIM2CERV Study; the success and timing of our clinical trials, including subject accrual; our ability to avoid and quickly resolve 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
KEYTRUDA® is a registered trademark of
Advaxis, Inc. |
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Selected Balance Sheet Data |
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(In thousands) |
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|
|||||
October 31, |
October 31, |
||||
2019 |
2018 |
||||
Cash and cash equivalents |
$ |
32,363 |
$ |
44,141 |
|
Restricted cash |
$ |
- |
$ |
977 |
|
Total assets |
$ |
45,257 |
$ |
62,267 |
|
Total stockholders’ equity |
$ |
39,531 |
$ |
24,051 |
STATEMENTS OF OPERATIONS |
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(in thousands, except share and per share data) |
|||||||
|
Year Ended |
|
|||||
|
2019 |
|
2018 |
|
|||
|
|
|
|
|
|||
Revenue |
$ |
20,884 |
|
$ |
6,063 |
|
|
|
|
|
|
|
|
|
|
Operating expenses* |
|
|
|
|
|
|
|
Research and development expenses |
|
26,677 |
|
|
56,970 |
|
|
General and administrative expenses |
|
12,179 |
|
|
19,472 |
|
|
Total operating expenses |
|
38,856 |
|
|
76,442 |
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
(17,972) |
|
|
(70,379) |
|
|
|
|
|
|
|
|
|
|
Other income |
|
1,410 |
|
|
3,914 |
|
|
Net loss |
$ |
(16,562) |
|
$ |
(66,465) |
|
|
|
|
|
|
|
|
||
Net loss per common share, basic and diluted |
$ |
(1.09) |
|
$ |
(19.36) |
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares outstanding, basic and diluted |
|
15,207,637 |
|
|
3,434,824 |
|
|
|
|
|
|
|
|
|
|
* Includes stock-based compensation as follows: |
|
|
|
|
|
|
|
Research and development |
$ |
1,036 |
|
$ |
2,836 |
|
|
General and administrative |
|
966 |
|
|
4,147 |
|
|
|
$ |
2,002 |
|
$ |
6,983 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20191220005089/en/
Source:
Tim McCarthy, LifeSci Advisors, LLC
212.915.2564
tim@lifesciadvisors.com