Advaxis Reports Third Quarter Ended July 31, 2022 Financial Results and Provides a Business Update
Advaxis Reports Third Quarter Ended July 31, 2022 Financial Results and Provides a Business Update
Announced completion of first dose level and enrollment initiation for second dose level in investigator-sponsored study of ADXS-504 in biochemically recurrent prostate cancer
宣布完成研究人员赞助的ADXS-504在生化复发前列腺癌中的第一剂量水平和第二剂量水平的登记
Cash runway extends into fiscal third quarter of 2024
现金跑道延伸至2024财年第三季度
MONMOUTH JUNCTION, N.J., Sept. 12, 2022 (GLOBE NEWSWIRE) -- Advaxis, Inc. (OTCQX: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, today announces its financial results for the third quarter ended July 31, 2022 and provides a business update.
新泽西州蒙茅斯交界处，9月2022年12月12日(Global Newswire)-专注于免疫疗法产品的开发和商业化的临床阶段生物技术公司Advaxis，Inc.(OTCQX：ADXS)今天宣布了截至2022年7月31日的第三季度财务业绩，并提供了业务最新情况。
Third Quarter Ended July 31, 2022 Financial Results and Recent Key Accomplishments:
截至2022年7月31日的第三季度财务业绩和最近的主要成就：
- Announced completion of first dose level in investigator-sponsored study in biochemically recurrent prostate cancer.
- The preliminary clinical assessment showed that at the first dose level ADXS-504 monotherapy is safe and well tolerated.
- The company plans to present clinical data and PSA values, for patients in both cohorts at a future medical conference.
- Announced enrollment initiation for second dose level cohort of investigator-sponsored clinical trial of ADXS-504 (HOT Prostate) in biochemically recurrent prostate cancer at Columbia University.
- 宣布完成研究人员赞助的生化复发前列腺癌的第一剂量水平研究。
- 初步临床评估表明，在第一剂量水平，ADXS-504单一疗法是安全和耐受性良好的。
- 该公司计划在未来的医学会议上为这两个队列的患者提供临床数据和PSA值。
- 宣布在哥伦比亚大学启动ADXS-504(热前列腺癌)治疗生化复发前列腺癌的研究人员赞助的第二剂量水平临床试验的登记工作。
Management Commentary
管理评论
Kenneth A. Berlin, President and Chief Executive Officer of Advaxis said, "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."
柏林和Advaxis首席执行官肯尼斯·A·柏林和总裁表示：“我们在ADXS-504的开发方面继续取得进展。我们宣布，我们已经完成了研究人员赞助的ADXS-504治疗生化复发前列腺癌的第一剂量水平的试验，数据表明这种新型疗法是安全的，耐受性良好。此外，我们已经开始招募第二剂量队列，并期待在2023年上半年报告安全性和初步临床数据。”伯林补充说，“考虑到我们已经采取的控制开支的措施，我们仍然预计，我们的现金跑道将持续到2024年第三财季。”
Third Quarter Ended July 31, 2022 Financial Results
截至2022年7月31日的第三季度财务业绩
Research and development expenses for the third quarter of fiscal year 2022 were $2.2 million compared with $1.7 million for the third quarter of fiscal year 2021. The increase of $0.5 million was primarily attributable to patient recruitment and manufacturing costs associated with our ADXS-503 clinical trial program. General and administrative expenses for the three months ended July 31, 2022 were approximately $2.1 million, compared to $2.7 million in the same three-month period in 2021. The decrease of $0.6 million primarily relates to legal and consulting fees with a previously proposed merger transaction and proxy solicitation fees in the prior period, partially offset by settlements from stockholder demand letters in the current period.
2022财年第三季度的研发支出为220万美元，而2021财年第三季度的研发支出为170万美元。增加50万美元的主要原因是与我们的ADXS-503临床试验计划相关的患者招募和制造成本。截至2022年7月31日的三个月的一般和行政费用约为210万美元，而2021年同期为270万美元。减少的60万美元主要涉及先前拟议合并交易的法律和咨询费，以及上期的委托书征集费，但被本期股东索要函的和解部分抵消。
As of July 31, 2022, the Company had approximately $28.2 million in cash and cash equivalents.
截至2022年7月31日，该公司拥有约2820万美元的现金和现金等价物。
About Advaxis, Inc.
Advaxis公司简介
Advaxis, Inc. is a clinical-stage biotechnology company focused on the 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，Inc.是一家临床阶段的生物技术公司，专注于基于LM的专有抗原输送产品的开发和商业化。这些免疫疗法基于一种平台技术，该技术利用生物工程减毒的单核细胞增生性李斯特菌(Lm)分泌抗原/佐剂融合蛋白。这些基于LM的菌株被认为是免疫治疗的重大进步，因为它们将多种功能集成到单一免疫疗法中，旨在访问和指导抗原提呈细胞以刺激抗肿瘤T细胞免疫，利用相当于多种佐剂的激活免疫系统，同时减少肿瘤微环境中的肿瘤保护，使T细胞能够清除肿瘤。
To learn more about Advaxis, visit .
要了解有关Advaxis的更多信息，请访问。
Forward-Looking Statements
前瞻性陈述
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 clinical development of the Company's drug product candidates, statements about the Company's balance sheet position, and statements related to the goals, plans and expectations for the Company's ongoing clinical studies. These and other risks are discussed in the Company's filings with the SEC, including, without limitation, its Annual Report on Form 10-K for the year ended October 31, 2021, filed on February 14, 2022, and its subsequent periodic reports on Form 10-Q and Form 8-K. 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.
本新闻稿包含根据修订后的1933年证券法第27A节和修订后的1934年证券交易法第21E节中的安全港条款作出的前瞻性陈述。前瞻性陈述是任何表达管理层当前信念和期望的陈述，包括但不限于与公司候选药物的预期临床发展有关的陈述、关于公司资产负债表状况的陈述以及与公司正在进行的临床研究的目标、计划和期望有关的陈述。公司在提交给美国证券交易委员会的文件中讨论了这些和其他风险，包括但不限于2022年2月14日提交的截至2021年10月31日的Form 10-K年度报告以及随后的Form 10-Q和Form 8-K定期报告。本文中任何没有描述历史事实的陈述都是前瞻性陈述，会受到风险和不确定因素的影响，这些风险和不确定性可能会导致实际结果、业绩和成就与这些前瞻性陈述中讨论的大不相同。该公司告诫读者不要过度依赖任何前瞻性陈述，因为这些陈述只反映了它们发表之日的情况。
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.
公司不承担更新或修改前瞻性陈述的义务，除非法律另有要求，无论是由于新信息、未来事件或其他原因。
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA.
Keytruda®是默克·夏普·多姆公司的注册商标，默克·夏普·多姆公司是默克公司在美国新泽西州凯尼尔沃斯的子公司。
Contact:
Tim McCarthy, LifeSci Advisors, LLC
212.915.2564
tim@lifesciadvisors.com
联系方式：
蒂姆·麦卡锡，LifeSci Advisors，LLC
212.915.2564
邮箱：Tim@lifescivisors.com
|
ADVAXIS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands, except share and per share data) | ||||||||
| July 31, 2022 | October 31, 2021 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 28,150 | $ | 41,614 | ||||
| Prepaid expenses and other current assets | 1,667 | 1,643 | ||||||
| Total current assets | 29,817 | 43,257 | ||||||
| Property and equipment (net of accumulated depreciation) | 73 | 118 | ||||||
| Intangible assets (net of accumulated amortization) | 181 | 3,354 | ||||||
| Operating right-of-use asset (net of accumulated amortization) | 19 | 40 | ||||||
| Other assets | 11 | 11 | ||||||
| Total assets | $ | 30,101 | $ | 46,780 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 90 | $ | 87 | ||||
| Accrued expenses | 1,510 | 2,836 | ||||||
| Current portion of operating lease liability | 19 | 28 | ||||||
| Common stock warrant liability | 287 | 4,929 | ||||||
| Total current liabilities | 1,906 | 7,880 | ||||||
| Operating lease liability, net of current portion | - | 12 | ||||||
| Total liabilities | 1,906 | 7,892 | ||||||
| Contingencies – Note 8 | ||||||||
| Series D convertible preferred stock- $0.001 par value; 1,000,000 shares authorized, issued and outstanding at July 31, 2022 and October 31, 2021. | - | - | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock, $0.001 par value; 5,000,000 shares authorized, 0 shares issued and outstanding at July 31, 2022 and October 31, 2021. | - | - | ||||||
| Common stock - $0.001 par value; 170,000,000 shares authorized, 1,815,951 and 1,820,452 shares issued and outstanding 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' equity | 28,195 | 38,888 | ||||||
| Total liabilities and stockholders' equity | $ | 30,101 | $ | 46,780 | ||||
|
Advax，Inc. 简明合并资产负债表 (以千为单位，不包括每股和每股数据) | ||||||||
| 2022年7月31日 | 2021年10月31日 | |||||||
| (未经审计) | ||||||||
| 资产 | ||||||||
| 流动资产： | ||||||||
| 现金和现金等价物 | $ | 28,150 | $ | 41,614 | ||||
| 预付费用和其他流动资产 | 1,667 | 1,643 | ||||||
| 流动资产总额 | 29,817 | 43,257 | ||||||
| 财产和设备(扣除累计折旧) | 73 | 118 | ||||||
| 无形资产(累计摊销净额) | 181 | 3,354 | ||||||
| 经营性使用权资产(累计摊销净额) | 19 | 40 | ||||||
| 其他资产 | 11 | 11 | ||||||
| 总资产 | $ | 30,101 | $ | 46,780 | ||||
| 负债和股东权益 | ||||||||
| 流动负债： | ||||||||
| 应付帐款 | $ | 90 | $ | 87 | ||||
| 应计费用 | 1,510 | 2,836 | ||||||
| 经营租赁负债的当期部分 | 19 | 28 | ||||||
| 普通股认股权证责任 | 287 | 4,929 | ||||||
| 流动负债总额 | 1,906 | 7,880 | ||||||
| 经营租赁负债，扣除当期部分 | - | 12 | ||||||
| 总负债 | 1,906 | 7,892 | ||||||
| 或有事项--附注8 | ||||||||
| D系列可转换优先股-面值0.001美元；授权、发行和流通股100万股，分别于2022年7月31日和2021年10月31日发行。 | - | - | ||||||
| 股东权益： | ||||||||
| 优先股，面值0.001美元；授权5,000,000股，于2022年7月31日和2021年10月31日发行和发行0股。 | - | - | ||||||
| 普通股-面值0.001美元；授权170,000,000股，2022年7月31日和2021年10月31日发行和发行的1,815,951股和1,820,452股。 | 2 | 2 | ||||||
| 额外实收资本 | 466,561 | 467,486 | ||||||
| 累计赤字 | (438,368 | ) | (428,600 | ) | ||||
| 股东权益总额 | 28,195 | 38,888 | ||||||
| 总负债和股东权益 | $ | 30,101 | $ | 46,780 | ||||
|
ADVAXIS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) (In thousands, except share and per share data) | ||||||||
| Three Months Ended July 31, |
||||||||
| 2022 | 2021 | |||||||
| Revenue | $ | - | $ | 250 | ||||
| Operating expenses: | ||||||||
| Research and development expenses | 2,233 | 1,703 | ||||||
| General and administrative expenses | 2,053 | 2,678 | ||||||
| Intangible | 3,005 | - | ||||||
| Total operating expenses | 7,291 | 4,381 | ||||||
| Loss from operations | (7,291 | ) | (4,131 | ) | ||||
| Other income (expense): | ||||||||
| Interest income, net | 50 | 1 | ||||||
| Net changes in fair value of derivative liabilities | 276 | 846 | ||||||
| Other (expense) income | 2 | - | ||||||
| Net loss before income taxes | (6,963 | ) | (3,284 | ) | ||||
| Income tax expense | - | 50 | ||||||
| Net loss | $ | (6,963 | ) | $ | (3,334 | ) | ||
| Net loss per common share, basic and diluted | $ | (3.83 | ) | $ | (1.83 | ) | ||
| Weighted average number of common shares, basic and diluted | 1,817,761 | 1,820,452 | ||||||
|
Advax，Inc. 简明合并业务报表(未经审计) (以千为单位，不包括每股和每股数据) | ||||||||
| 截至三个月 7月31日， |
||||||||
| 2022 | 2021 | |||||||
| 收入 | $ | - | $ | 250 | ||||
| 运营费用： | ||||||||
| 研发费用 | 2,233 | 1,703 | ||||||
| 一般和行政费用 | 2,053 | 2,678 | ||||||
| 无形的 | 3,005 | - | ||||||
| 总运营费用 | 7,291 | 4,381 | ||||||
| 运营亏损 | (7,291 | ) | (4,131 | ) | ||||
| 其他收入(支出)： | ||||||||
| 利息收入，净额 | 50 | 1 | ||||||
| 衍生负债公允价值净变动 | 276 | 846 | ||||||
| 其他(费用)收入 | 2 | - | ||||||
| 所得税前净亏损 | (6,963 | ) | (3,284 | ) | ||||
| 所得税费用 | - | 50 | ||||||
| 净亏损 | $ | (6,963 | ) | $ | (3,334 | ) | ||
| 每股普通股基本亏损和摊薄后净亏损 | $ | (3.83 | ) | $ | (1.83 | ) | ||
| 基本普通股和稀释普通股的加权平均数 | 1,817,761 | 1,820,452 | ||||||