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
宣佈完成研究人員贊助的ADXS-504在生化復發前列腺癌中的第一劑量水平和第二劑量水平的登記
Cash runway extends into fiscal third quarter of 2024
現金跑道延伸至2024財年第三季度
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.
新澤西州蒙茅斯交界處，9月2022年12月12日(Global Newswire)-專注於免疫療法產品的開發和商業化的臨牀階段生物技術公司Advaxis，Inc.(OTCQX：ADXS)今天宣佈了截至2022年7月31日的第三季度財務業績，並提供了業務最新情況。
Third Quarter Ended July 31, 2022 Financial Results and Recent Key Accomplishments:
截至2022年7月31日的第三季度財務業績和最近的主要成就：
- 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.
- 宣佈完成研究人員贊助的生化復發前列腺癌的第一劑量水平研究。
- 初步臨牀評估表明，在第一劑量水平，ADXS-504單一療法是安全和耐受性良好的。
- 該公司計劃在未來的醫學會議上為這兩個隊列的患者提供臨牀數據和PSA值。
- 宣佈在哥倫比亞大學啟動ADXS-504(熱前列腺癌)治療生化復發前列腺癌的研究人員贊助的第二劑量水平臨牀試驗的登記工作。
Management Commentary
管理評論
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首席執行官肯尼斯·A·柏林和總裁表示：“我們在ADXS-504的開發方面繼續取得進展。我們宣佈，我們已經完成了研究人員贊助的ADXS-504治療生化復發前列腺癌的第一劑量水平的試驗，數據表明這種新型療法是安全的，耐受性良好。此外，我們已經開始招募第二劑量隊列，並期待在2023年上半年報告安全性和初步臨牀數據。”伯林補充説，“考慮到我們已經採取的控制開支的措施，我們仍然預計，我們的現金跑道將持續到2024年第三財季。”
Third Quarter Ended July 31, 2022 Financial Results
截至2022年7月31日的第三季度財務業績
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財年第三季度的研發支出為220萬美元，而2021財年第三季度的研發支出為170萬美元。增加50萬美元的主要原因是與我們的ADXS-503臨牀試驗計劃相關的患者招募和製造成本。截至2022年7月31日的三個月的一般和行政費用約為210萬美元，而2021年同期為270萬美元。減少的60萬美元主要涉及先前擬議合併交易的法律和諮詢費，以及上期的委託書徵集費，但被本期股東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，該公司擁有約2820萬美元的現金和現金等價物。
About Advaxis, Inc.
Advaxis公司簡介
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.是一家臨牀階段的生物技術公司，專注於基於LM的專有抗原輸送產品的開發和商業化。這些免疫療法基於一種平臺技術，該技術利用生物工程減毒的單核細胞增生性李斯特菌(Lm)分泌抗原/佐劑融合蛋白。這些基於LM的菌株被認為是免疫治療的重大進步，因為它們將多種功能集成到單一免疫療法中，旨在訪問和指導抗原提呈細胞以刺激抗腫瘤T細胞免疫，利用相當於多種佐劑的激活免疫系統，同時減少腫瘤微環境中的腫瘤保護，使T細胞能夠清除腫瘤。
To learn more about Advaxis, visit .
要了解有關Advaxis的更多信息，請訪問。
Forward-Looking Statements
前瞻性陳述
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.
本新聞稿包含根據修訂後的1933年證券法第27A節和修訂後的1934年證券交易法第21E節中的安全港條款作出的前瞻性陳述。前瞻性陳述是任何表達管理層當前信念和期望的陳述，包括但不限於與公司候選藥物的預期臨牀發展有關的陳述、關於公司資產負債表狀況的陳述以及與公司正在進行的臨牀研究的目標、計劃和期望有關的陳述。公司在提交給美國證券交易委員會的文件中討論了這些和其他風險，包括但不限於2022年2月14日提交的截至2021年10月31日的Form 10-K年度報告以及隨後的Form 10-Q和Form 8-K定期報告。本文中任何沒有描述歷史事實的陳述都是前瞻性陳述，會受到風險和不確定因素的影響，這些風險和不確定性可能會導致實際結果、業績和成就與這些前瞻性陳述中討論的大不相同。該公司告誡讀者不要過度依賴任何前瞻性陳述，因為這些陳述只反映了它們發表之日的情況。
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.
公司不承擔更新或修改前瞻性陳述的義務，除非法律另有要求，無論是由於新信息、未來事件或其他原因。
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·多姆公司的註冊商標，默克·夏普·多姆公司是默克公司在美國新澤西州凱尼爾沃斯的子公司。
Contact:
Tim McCarthy, LifeSci Advisors, LLC
212.915.2564
tim@lifesciadvisors.com
聯繫方式：
蒂姆·麥卡錫，LifeSci Advisors，LLC
212.915.2564
郵箱：Tim@lifescivisors.com
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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 | ||||
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Advax，Inc. 簡明合併資產負債表 (以千為單位，不包括每股和每股數據) | ||||||||
| 2022年7月31日 | 2021年10月31日 | |||||||
| (未經審計) | ||||||||
| 資產 | ||||||||
| 流動資產： | ||||||||
| 現金和現金等價物 | $ | 28,150 | $ | 41,614 | ||||
| 預付費用和其他流動資產 | 1,667 | 1,643 | ||||||
| 流動資產總額 | 29,817 | 43,257 | ||||||
| 財產和設備(扣除累計折舊) | 73 | 118 | ||||||
| 無形資產(累計攤銷淨額) | 181 | 3,354 | ||||||
| 經營性使用權資產(累計攤銷淨額) | 19 | 40 | ||||||
| 其他資產 | 11 | 11 | ||||||
| 總資產 | $ | 30,101 | $ | 46,780 | ||||
| 負債和股東權益 | ||||||||
| 流動負債： | ||||||||
| 應付帳款 | $ | 90 | $ | 87 | ||||
| 應計費用 | 1,510 | 2,836 | ||||||
| 經營租賃負債的當期部分 | 19 | 28 | ||||||
| 普通股認股權證責任 | 287 | 4,929 | ||||||
| 流動負債總額 | 1,906 | 7,880 | ||||||
| 經營租賃負債，扣除當期部分 | - | 12 | ||||||
| 總負債 | 1,906 | 7,892 | ||||||
| 或有事項--附註8 | ||||||||
| D系列可轉換優先股-面值0.001美元；授權、發行和流通股100萬股，分別於2022年7月31日和2021年10月31日發行。 | - | - | ||||||
| 股東權益： | ||||||||
| 優先股，面值0.001美元；授權5,000,000股，於2022年7月31日和2021年10月31日發行和發行0股。 | - | - | ||||||
| 普通股-面值0.001美元；授權170,000,000股，2022年7月31日和2021年10月31日發行和發行的1,815,951股和1,820,452股。 | 2 | 2 | ||||||
| 額外實收資本 | 466,561 | 467,486 | ||||||
| 累計赤字 | (438,368 | ) | (428,600 | ) | ||||
| 股東權益總額 | 28,195 | 38,888 | ||||||
| 總負債和股東權益 | $ | 30,101 | $ | 46,780 | ||||
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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 | ||||||
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Advax，Inc. 簡明合併業務報表(未經審計) (以千為單位，不包括每股和每股數據) | ||||||||
| 截至三個月 7月31日， |
||||||||
| 2022 | 2021 | |||||||
| 收入 | $ | - | $ | 250 | ||||
| 運營費用： | ||||||||
| 研發費用 | 2,233 | 1,703 | ||||||
| 一般和行政費用 | 2,053 | 2,678 | ||||||
| 無形的 | 3,005 | - | ||||||
| 總運營費用 | 7,291 | 4,381 | ||||||
| 運營虧損 | (7,291 | ) | (4,131 | ) | ||||
| 其他收入(支出)： | ||||||||
| 利息收入，淨額 | 50 | 1 | ||||||
| 衍生負債公允價值淨變動 | 276 | 846 | ||||||
| 其他(費用)收入 | 2 | - | ||||||
| 所得税前淨虧損 | (6,963 | ) | (3,284 | ) | ||||
| 所得税費用 | - | 50 | ||||||
| 淨虧損 | $ | (6,963 | ) | $ | (3,334 | ) | ||
| 每股普通股基本虧損和攤薄後淨虧損 | $ | (3.83 | ) | $ | (1.83 | ) | ||
| 基本普通股和稀釋普通股的加權平均數 | 1,817,761 | 1,820,452 | ||||||