Advaxis Reports Second Quarter Ended April 30, 2021 Financial Results and Provides a Business Update
ADXS-503 Phase 1/2 trial data presented at ASCO demonstrate disease control rate of 44% with durable clinical benefit observed beyond one year in patients with disease progression on KEYTRUDA®
Expansion of off-the-shelf ADXS-HOT program with planned Phase 1 study in early prostate cancer with biochemical recurrence
Cash runway anticipated into fiscal 3rd quarter of 2023
Second Quarter Ended
- Presented updated clinical data from the ongoing Phase 1/2 trial of ADXS-503 as a monotherapy and in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in non-small cell lung cancer (NSCLC) at the
American Society of Clinical Oncology (ASCO) 2021 Annual Meeting- 10 patients have been treated with ADXS-503 as an add on therapy in patients failing pembrolizumab as last therapy with 10 patients evaluable for safety and 9 patients evaluable for efficacy
- Combination therapy was well tolerated with no dose-limiting toxicities (DLTs) or added toxicity of the two drugs
- The disease control rate (DCR) was 44% (4/9) with durable clinical benefit observed including a partial response (PR) and stable disease (SD) sustained for over a year, and another observed SD lasting over 6 months. An additional PR was maintained for approximately 4 months
- Biomarker data demonstrate that patients who seem to achieve clinical benefit include those with PD-L1 expression ≥50%, secondary resistance disease to pembrolizumab and those who show proliferation and/or activation of NK and CD8+ T cells within the first weeks of therapy
- Translational studies show antitumoral T-cell responses elicited against hot-spot mutation antigens and/or tumor associated antigens (TAAs), induction of proliferation and/or activation of pre-existing CD8+ T-cell clones, emergence of naive CD8+ T cell clones, and PD-1 and CD38 upregulation
- Continuing to enroll patients for treatment with ADXS-503 in combination with KEYTRUDA® (pembrolizumab) as first line therapy as well
- Presented data at the
American Association for Cancer Research (AACR) 2021 Annual meeting, in collaboration withPrecision for Medicine , on the development of a novel immunophenotyping assay to accurately evaluate PD-1 expression as a pharmacodynamic marker during PD-1 blockade treatment with pembrolizumab, and the correlation of changes in T cell populations with observed clinical activity in the ongoing ADXS-503 clinical trial - Announced agreement with
Columbia University Irving Medical Center to fund Phase 1 Study of ADXS-504 for the treatment of early prostate cancer with biochemical recurrence - Achieved second milestone under ADXS-HER2 licensing agreement with OS Therapies
- Announced
$20 million registered direct offering and concurrent private placement priced at-the-market with two healthcare-focused institutional investors to fund continued development and expansion of the Company’s product pipeline - Cash balance at
April 30, 2021 of$48.1 million providing the Company with an anticipated cash runaway into fiscal 3rd quarter of 2023.
Management Commentary
“Our recent presentation at ASCO adds to the strong foundation of data which suggest treatment with ADXS-503 has the potential provide durable clinical benefit in patients with certain clinical characteristics and early T cell responses,” said
Second Quarter Ended
Research and development expenses for the second quarter of fiscal year 2021 were $4.34 million, compared with $3.92 for the second quarter of fiscal year 2020. The increase of
General and administrative expenses for the three months ended
As of
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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, statements about the Company’s balance sheet position, including the sufficiency of the Company’s cash and cash equivalents to fund its obligations into the future, 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
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.,
Contact:
Tim McCarthy, LifeSci Advisors, LLC
212.915.2564
tim@lifesciadvisors.com
CONDENSED BALANCE SHEETS | |||||||
(In thousands, except share and per share data) | |||||||
(Unaudited) | 2020 | ||||||
ASSETS | |||||||
Current Assets: | |||||||
Cash and cash equivalents | $ | 48,110 | $ | 25,178 | |||
Deferred expenses | 1,333 | 1,808 | |||||
Accounts receivable | 1,375 | - | |||||
Prepaid expenses and other current assets | 1,295 | 865 | |||||
Total current assets | 52,113 | 27,851 | |||||
Property and equipment (net of accumulated depreciation) | 333 | 2,393 | |||||
Intangible assets (net of accumulated amortization) | 3,325 | 3,261 | |||||
Operating right-of-use asset (net of accumulated amortization) | - | 4,839 | |||||
Other assets | - | 182 | |||||
Total assets | $ | 55,771 | $ | 38,526 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 1,156 | $ | 410 | |||
Accrued expenses | 2,133 | 1,737 | |||||
Common stock warrant liability | 4,931 | 17 | |||||
Current portion of operating lease liability | - | 962 | |||||
Deferred revenue | - | 165 | |||||
Total current liabilities | 8,220 | 3,291 | |||||
Operating lease liability, net of current portion | - | 5,055 | |||||
Total liabilities | 8,220 | 8,346 | |||||
Commitments and contingencies – Note 9 | |||||||
Stockholders’ equity: | |||||||
Preferred stock, |
- | - | |||||
Common stock - |
146 | 78 | |||||
Additional paid-in capital | 467,227 | 440,840 | |||||
Accumulated deficit | (419,822 | ) | (410,738 | ) | |||
Total stockholders’ equity | 47,551 | 30,180 | |||||
Total liabilities and stockholders’ equity | $ | 55,771 | $ | 38,526 |
CONDENSED STATEMENTS OF OPERATIONS (Unaudited) | |||||||||||||||
(In thousands, except share and per share data) | |||||||||||||||
Three Months Ended | Six Months Ended | ||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||
Revenue | $ | 1,375 | $ | 250 | $ | 2,990 | $ | 253 | |||||||
Operating expenses: | |||||||||||||||
Research and development expenses | 4,344 | 3,922 | 6,914 | 8,781 | |||||||||||
General and administrative expenses | 3,352 | 2,649 | 6,360 | 5,679 | |||||||||||
Total operating expenses | 7,696 | 6,571 | 13,274 | 14,460 | |||||||||||
Loss from operations | (6,321 | ) | (6,321 | ) | (10,284 | ) | (14,207 | ) | |||||||
Other income (expense): | |||||||||||||||
Interest income, net | 2 | 35 | 3 | 101 | |||||||||||
Net changes in fair value of derivative liabilities | 995 | 14 | 968 | (23 | ) | ||||||||||
Other income (expense) | 217 | (1 | ) | 229 | (1 | ) | |||||||||
Net loss before income taxes | (5,107 | ) | (6,273 | ) | (9,084 | ) | (14,130 | ) | |||||||
Income tax expense | - | 50 | - | 50 | |||||||||||
Net loss | $ | (5,107 | ) | $ | (6,323 | ) | $ | (9,084 | ) | $ | (14,180 | ) | |||
Net loss per common share, basic and diluted | $ | (0.04 | ) | $ | (0.10 | ) | $ | (0.08 | ) | $ | (0.25 | ) | |||
Weighted average number of common shares, basic and diluted | 123,145,051 | 60,572,632 | 111,895,403 | 56,107,657 |
CONDENSED STATEMENTS OF CASH FLOWS (Unaudited) | |||||||
(In thousands) | |||||||
Six Months Ended | |||||||
2021 | 2020 | ||||||
OPERATING ACTIVITIES | |||||||
Net loss | $ | (9,084 | ) | $ | (14,180 | ) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
Stock compensation | 451 | 452 | |||||
Employee stock purchase plan expense | - | 1 | |||||
Loss (gain) on change in value of warrants | (968 | ) | 23 | ||||
Loss on disposal of property and equipment | 1,530 | - | |||||
Loss on write-down of intangible assets | 69 | - | |||||
Abandonment of intangible assets | - | 603 | |||||
Depreciation expense | 316 | 457 | |||||
Amortization expense of intangible assets | 135 | 181 | |||||
Amortization of right-of-use asset | 327 | 365 | |||||
Net gain on write off of right-of-use asset and lease liability | (1,116 | ) | - | ||||
Change in operating assets and liabilities: | |||||||
Accounts receivable | (1,375 | ) | - | ||||
Prepaid expenses, other current assets and deferred expenses | 45 | 235 | |||||
Other assets | 182 | 1 | |||||
Accounts payable and accrued expenses | 1,142 | (1,161 | ) | ||||
Deferred revenue | (165 | ) | - | ||||
Operating lease liabilities | (389 | ) | (397 | ) | |||
Net cash used in operating activities | (8,900 | ) | (13,420 | ) | |||
INVESTING ACTIVITIES | |||||||
Proceeds from disposal of property and equipment | 214 | - | |||||
Cost of intangible assets | (268 | ) | (358 | ) | |||
Net cash used in investing activities | (54 | ) | (358 | ) | |||
FINANCING ACTIVITIES | |||||||
Net proceeds of issuance of common stock and warrants | 28,115 | 9,628 | |||||
Warrant exercises | 3,771 | - | |||||
Proceeds from employee stock purchase plan | - | 4 | |||||
Net cash provided by financing activities | 31,886 | 9,632 | |||||
Net increase in cash and cash equivalents | 22,932 | (4,146 | ) | ||||
Cash and cash equivalents at beginning of period | 25,178 | 32,363 | |||||
Cash and cash equivalents at end of period | $ | 48,110 | $ | 28,217 | |||
SUPPLEMENTAL CASH FLOW INFORMATION | |||||||
Cash paid for taxes | $ | - | $ | 50 | |||
SUPPLEMENTAL DISCLOSURE OF NON-CASH AND FINANCING ACTIVITIES | |||||||
Warrant liability reclassified into equity | - | 2 |
Source: Advaxis, Inc.