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Announced completion of first dose stage and enrollment initiation for second dose stage in investigator-sponsored research of ADXS-504 in biochemically recurrent prostate most cancers
Cash runway extends into fiscal third quarter of 2024
MONMOUTH JUNCTION, N.J., Sept. 12, 2022 (GLOBE NEWSWIRE) — Advaxis, Inc. (OTCQX: ADXS), a clinical-stage biotechnology firm centered on the event and commercialization of immunotherapy merchandise, right now broadcasts its monetary outcomes for the third quarter ended July 31, 2022 and offers a business replace.
Third Quarter Ended July 31, 2022 Financial Results and Recent Key Accomplishments:
- Announced completion of first dose stage in investigator-sponsored research in biochemically recurrent prostate most cancers.
- The preliminary medical evaluation confirmed that on the first dose stage ADXS-504 monotherapy is protected and effectively tolerated.
- The firm plans to current medical knowledge and PSA values, for sufferers in each cohorts at a future medical convention.
- Announced enrollment initiation for second dose stage cohort of investigator-sponsored medical trial of ADXS-504 (HOT Prostate) in biochemically recurrent prostate most cancers at Columbia University.
Management Commentary
Kenneth A. Berlin, President and Chief Executive Officer of Advaxis stated, “We continue to make progress in our development of ADXS-504. We announced that we have completed the first dose level in our investigator-sponsored trial of ADXS-504 in biochemically recurrent prostate cancer and the data suggest that this novel therapeutic is safe and well-tolerated. In addition, we have initiated enrollment for the second dose cohort and look forward to reporting safety and initial clinical data in the first half of 2023.” Mr. Berlin added, “Given the measures we have undertaken to control expenses, we continue to expect that our cash runway will reach into the third fiscal quarter of 2024.”
Third Quarter Ended July 31, 2022 Financial Results
Research and improvement bills for the third quarter of fiscal yr 2022 had been $2.2 million in contrast with $1.7 million for the third quarter of fiscal yr 2021. The enhance of $0.5 million was primarily attributable to affected person recruitment and manufacturing prices related to our ADXS-503 medical trial program. General and administrative bills for the three months ended July 31, 2022 had been roughly $2.1 million, in comparison with $2.7 million in the identical three-month interval in 2021. The lower of $0.6 million primarily pertains to authorized and consulting charges with a beforehand proposed merger transaction and proxy solicitation charges within the prior interval, partially offset by settlements from stockholder demand letters within the present interval.
As of July 31, 2022, the Company had roughly $28.2 million in money and money equivalents.
About Advaxis, Inc.
Advaxis, Inc. is a clinical-stage biotechnology firm centered on the event and commercialization of proprietary Lm-based antigen supply merchandise. These immunotherapies are based mostly on a platform expertise that makes use of dwell attenuated Listeria monocytogenes (Lm) bioengineered to secrete antigen/adjuvant fusion proteins. These Lm-based strains are believed to be a big development in immunotherapy as they combine a number of features right into a single immunotherapy and are designed to entry and direct antigen presenting cells to stimulate anti-tumor T cell immunity, activate the immune system with the equal of a number of adjuvants, and concurrently scale back tumor safety within the tumor microenvironment to allow T cells to get rid of tumors.
To study extra about Advaxis, go to www.advaxis.com.
Forward-Looking Statements
This press launch incorporates forward-looking statements which are made pursuant to the protected harbor provisions throughout the that means 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 categorical the present beliefs and expectations of administration, together with however not restricted to statements associated to the anticipated medical improvement of the Company’s drug product candidates, statements concerning the Company’s stability sheet place, and statements associated to the targets, plans and expectations for the Company’s ongoing medical research. These and different dangers are mentioned within the Company’s filings with the SEC, together with, with out limitation, its Annual Report on Form 10-Okay for the yr ended October 31, 2021, filed on February 14, 2022, and its subsequent periodic studies on Form 10-Q and Form 8-Okay. Any statements contained herein that don’t describe historic info are forward-looking statements which are topic to dangers and uncertainties that might trigger precise outcomes, efficiency and achievements to vary materially from these mentioned in such forward-looking statements. The Company cautions readers to not place undue reliance on any forward-looking statements, which converse solely as of the date they had been made.
The Company undertakes no obligation to replace or revise forward-looking statements, besides as in any other case required by regulation, whether or not because of new data, future occasions or in any other case.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA.
Contact:
Tim McCarthy, LifeSci Advisors, LLC
212.915.2564
[email protected]
| ADVAXIS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (In hundreds, besides share and per share knowledge) |
||||||||
| July 31, 2022 | October 31, 2021 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current property: | ||||||||
| Cash and money equivalents | $ | 28,150 | $ | 41,614 | ||||
| Prepaid bills and different present property | 1,667 | 1,643 | ||||||
| Total present property | 29,817 | 43,257 | ||||||
| Property and gear (internet of accrued depreciation) | 73 | 118 | ||||||
| Intangible property (internet of accrued amortization) | 181 | 3,354 | ||||||
| Operating right-of-use asset (internet of accrued amortization) | 19 | 40 | ||||||
| Other property | 11 | 11 | ||||||
| Total property | $ | 30,101 | $ | 46,780 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 90 | $ | 87 | ||||
| Accrued bills | 1,510 | 2,836 | ||||||
| Current portion of working lease legal responsibility | 19 | 28 | ||||||
| Common inventory warrant legal responsibility | 287 | 4,929 | ||||||
| Total present liabilities | 1,906 | 7,880 | ||||||
| Operating lease legal responsibility, internet of present portion | – | 12 | ||||||
| Total liabilities | 1,906 | 7,892 | ||||||
| Contingencies – Note 8 | ||||||||
| Series D convertible most well-liked stock- $0.001 par worth; 1,000,000 shares licensed, issued and excellent at July 31, 2022 and October 31, 2021. | – | – | ||||||
| Stockholders’ fairness: | ||||||||
| Preferred inventory, $0.001 par worth; 5,000,000 shares licensed, 0 shares issued and excellent at July 31, 2022 and October 31, 2021. | – | – | ||||||
| Common inventory – $0.001 par worth; 170,000,000 shares licensed, 1,815,951 and 1,820,452 shares issued and excellent at July 31, 2022 and October 31, 2021. | 2 | 2 | ||||||
| Additional paid-in capital | 466,561 | 467,486 | ||||||
| Accumulated deficit | (438,368 | ) | (428,600 | ) | ||||
| Total stockholders’ fairness | 28,195 | 38,888 | ||||||
| Total liabilities and stockholders’ fairness | $ | 30,101 | $ | 46,780 | ||||
| ADVAXIS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) (In hundreds, besides share and per share knowledge) |
||||||||
| Three Months Ended July 31, |
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| 2022 | 2021 | |||||||
| Revenue | $ | – | $ | 250 | ||||
| Operating bills: | ||||||||
| Research and improvement bills | 2,233 | 1,703 | ||||||
| General and administrative bills | 2,053 | 2,678 | ||||||
| Intangible | 3,005 | – | ||||||
| Total working bills | 7,291 | 4,381 | ||||||
| Loss from operations | (7,291 | ) | (4,131 | ) | ||||
| Other revenue (expense): | ||||||||
| Interest revenue, internet | 50 | 1 | ||||||
| Net adjustments in truthful worth of spinoff liabilities | 276 | 846 | ||||||
| Other (expense) revenue | 2 | – | ||||||
| Net loss earlier than revenue taxes | (6,963 | ) | (3,284 | ) | ||||
| Income tax expense | – | 50 | ||||||
| Net loss | $ | (6,963 | ) | $ | (3,334 | ) | ||
| Net loss per frequent share, primary and diluted | $ | (3.83 | ) | $ | (1.83 | ) | ||
| Weighted common variety of frequent shares, primary and diluted | 1,817,761 | 1,820,452 | ||||||
