Advaxis Reports First Quarter Ended January 31, 2020 Financial Results and Provides a Pipeline Update
Key recent corporate and clinical pipeline updates:
- Presented updated clinical data from the ongoing Phase 1/2 ADXS-503 trial at the I/O 360° Conference. Data presented showed that the first two patients treated in the combination arm, who previously progressed on KEYTRUDA®, achieved a partial response with substantial tumor shrinkage of nearly 60% and the other patient achieving stable disease with a 25% reduction in a target lesion.
- Presented updated survival data from the Phase 1/2 ADXS-PSA trial at the ASCO Genitourinary Cancers Symposium. Data highlights include reported median overall survival (95% CI) of 16.4 months (4.0-NR) (n=11) for advanced prostate cancer patients with visceral metastases treated with ADXS-PSA in combination with KEYTRUDA® compared to an estimated 11 months with current standard of care. In addition, median overall survival (95% CI) was 33.7 months (15.4-33.7) in all patients treated with ADXS-PSA in combination with KEYTRUDA® (n=37).
- Data presented in 2020 suggest that both ADXS-503 and ADXS-PSA may have the potential to enhance or restore sensitivity to checkpoint inhibitors such as KEYTRUDA®.
- Announced FDA allowance of its Investigational New Drug Application (IND) for ADXS-504 for the treatment of prostate cancer. ADXS-504 is the Company’s second drug product candidate from its HOT off-the-shelf neoantigen clinical program targeting hotspot mutations and other tumor-associated antigens.
- Closing of a
$10.5 millionequity financing with two investors.
- Announced a research agreement with Personalis to deploy ImmunoID NeXT Platform in the ADXS-503 clinical program. Personalis will conduct comprehensive tumor immunogenic profiling to enable the identification of predictive composite biomarkers and/or signatures of response, as well as the broad evaluation of potential mechanisms of therapy resistance.
“We have started our fiscal year with encouraging positive data presented in our ADXS-PSA and ADXS-503 clinical programs,” said
First Quarter Ended
During the quarter ended
Research and development expenses for the first quarter of fiscal year 2020 were
General and administrative expenses for the three months ended
To learn more about
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are any statements that express the current beliefs and expectations of management, including but not limited to statements related to the expected clinical development of the Company’s drug product candidates. These and other risks are discussed in the Company’s filings with the
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.,
|Selected Balance Sheet Data|
|Cash and cash equivalents||$||34,156||$||32,363|
|Total stockholders’ equity||$||41,548||$||39,531|
|STATEMENTS OF OPERATIONS
|(in thousands, except share and per share data)
|Three Months Ended
|Research and development expenses||4,859||6,707|
|General and administrative expenses||3,030||2,666|
|Total operating expenses||7,889||9,373|
|(Loss) income from operations||(7,886||)||10,316|
|Net changes in fair value of derivative liabilities||(37||)||2,409|
|Other income and taxes||66||92|
|Net (loss) income||$||(7,857||)||$||12,817|
|Net (loss) income per common share, basic and diluted||$||(0.15||)||$||2.76|
|Weighted average number of common shares outstanding, basic||51,412,408||4,642,718|
|Weighted average number of common shares outstanding, diluted||51,412,408||4,642,817|
|* Includes stock-based compensation as follows:|
|Research and development||$||91||$||323|
|General and administrative||151||299|
Source: Advaxis, Inc.