Advaxis Reports Second Quarter Ended April 30, 2020 Financial Results and Provides a Business Update
Expanding Phase 1/2 Study of ADXS-503 in NSCLC based on sustained and durable clinical responses in first two patients from Part B combination arm with KEYTRUDA®
Increasing patient enrollment in Part B and initiating Part C to move into first-line regimen with KEYTRUDA® in patients ineligible for standard of care platinum-based chemotherapy
Conference call scheduled for
Key recent corporate and clinical pipeline updates:
- Presented updated clinical and preliminary biomarker data from the ongoing Phase 1/2 trial of ADXS-503 in non-small cell lung cancer (NSCLC) demonstrating clinical benefit in two patients with immediate prior progression on KEYTRUDA® including one durable response out to 25 weeks and another sustained response out to out least 16 weeks with both patients remaining on treatment in Part B, the combination arm with KEYTRUDA®
- One sustained partial response with 60% reduction in site lesions at 16 weeks and one durable response of stable disease with 25% reduction in target lesion at 25 weeks confirmed by radiographic scans
- Clinical benefit achieved after immediate prior progression on KEYTRUDA® with previous best responses of stable disease suggest ADXS-503 may re-sensitize or enhance response to KEYTRUDA®
- Part A monotherapy has been completed with three of six evaluable patients achieving responses of stable disease
- As monotherapy, as well as in combination with KEYTRUDA®, ADXS-503 appeared safe and well tolerated with no dose-limiting toxicities
- Preliminary biomarker data from seven patients in Part A monotherapy demonstrated activation of cytotoxic and memory CD8+ and CD4+ T cells in 100% of patients and antigen spreading in five of seven evaluable patients, including the first patient in combination therapy
- Presented updated survival data from the Phase 1/2 trial with ADXS-PSA in combination with KEYTRUDA® 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 prior docetaxel therapy and 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)
- Announced a research agreement with Personalis to deploy ImmunoID NeXT Platform in the ADXS-503 clinical program. Personalis will conduct comprehensive tumor genomic 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
Management Commentary
“We have continued our momentum throughout the second quarter with updated clinical data which support the prioritization of our off-the-shelf neoantigen HOT program,” said
Second Quarter Ended
Research and development expenses for the second quarter of fiscal year 2020 were
General and administrative expenses for the three months ended
As of
The company will host a conference call today at
Webcast: http://public.viavid.com/index.php?id=140132
Domestic: 877-407-0789
International: 201-689-8562
Conference ID: 13704683
About
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Forward-Looking Statements
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.,
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Selected Balance Sheet Data | |||||||
(In thousands) | |||||||
2020 | |||||||
(Unaudited) | 2019 | ||||||
Cash and cash equivalents | $ | 28,217 | $ | 32,363 | |||
Total assets | $ | 45,210 | $ | 45,257 | |||
Total stockholders’ equity | $ | 35,437 | $ | 39,531 |
STATEMENTS OF OPERATIONS
(unaudited, in thousands, except share and per share data)
Three Months Ended |
Six Months Ended |
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2020 | 2019 | 2020 | 2019 | ||||||||||||||
Revenue | $ | 250 | $ | 1,188 | $ | 253 | $ | 20,877 | |||||||||
Operating expenses * | |||||||||||||||||
Research and development expenses | 3,922 | 5,969 | 8,781 | 12,675 | |||||||||||||
General and administrative expenses | 2,649 | 3,092 | 5,679 | 5,759 | |||||||||||||
Total operating expenses | 6,571 | 9,061 | 14,460 | 18,434 | |||||||||||||
(Loss) income from operations | (6,321) | (7,873) | (14,207) | 2,443 | |||||||||||||
Other income (expense) | 48 | (1,510) | 97 | 1,041 | |||||||||||||
Net (loss) income before benefit for income taxes | (6,273) | (9,383) | (14,130) | 3,484 | |||||||||||||
Income tax expense | 50 | - | 50 | 50 | |||||||||||||
Net (loss) income | $ | (6,323) | $ | (9,383) | $ | (14,180) | $ | 3,434 | |||||||||
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Net (loss) income per common share, diluted | |||||||||||||||||
Basic | $ | (0.10) | $ | (1.59) | $ | (0.25) | $ | 0.65 | |||||||||
Diluted | $ | (0.10) | $ | (1.59) | $ | (0.25) | $ | 0.20 | |||||||||
Weighted average number of common shares outstanding | |||||||||||||||||
Basic | 60,572,632 | 5,900,449 | 56,107,657 | 5,259,677 | |||||||||||||
Diluted | 60,572,632 | 5,900,449 | 56,107,657 | 5,282,772 | |||||||||||||
* Includes stock-based compensation as follows: | |||||||||||||||||
Research and development | $ | 62 | $ | 258 | $ | 153 | $ | 581 | |||||||||
General and administrative | 148 | 221 | 299 | 520 | |||||||||||||
$ | 210 | $ | 479 | $ | 452 | $ | 1,101 |
Contact:
212.915.2564
tim@lifesciadvisors.com
Source: Advaxis, Inc.