Advaxis Reports Fiscal Year 2021 Financial Results and Provides a Business Update
Fiscal Year 2021 and Recent Key Accomplishments:
- Presented updated clinical data from ongoing Phase 1/2 Trial of ADXS-503 in NSCLC
- In Part B combination arm
- a second partial response was observed
- overall response rate was 15% and disease control rate was 46%
- In Part C combination arm in newly diagnosed subjects
- disease control rate of 67% was observed
- In Part B combination arm
- Initiated Phase 1 trial of ADXS-504 for the treatment of early prostate cancer
Management Commentary
“Fiscal year 2021 was a busy year for Advaxis, with important clinical and biomarker data from the ongoing Phase 1/2 study of ADXS-503 in NSCLC which now consistently show the potential of ADXS-503 to synergistically enhance and/or restore sensitivity to checkpoint inhibitors,” said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. “We are executing on the expansion of Part B to further evaluate the promising signals of sustained clinical benefit observed in Part B in NSCLC patients with immediate prior progression on KEYTRUDA®, as well as Part C, which will evaluate ADXS-503 in combination with KEYTRUDA® in the first line setting. Major milestones for the ADXS-503 trial in the second half of 2022 include updated clinical and immunogenicity data for all patients in Stage 1 in Part B and from up to 10 patients in Part C. Also, initial clinical and immunogenicity data from the ADXS-504 trial in early prostate cancer are expected to be reported in the second half of this year.”
Balance Sheet Highlights
As of October 31, 2021, Advaxis had cash and cash equivalents of $41.6 million. The Company used $15.4 million in cash to fund operations during fiscal year 2021, mainly attributed to funding research and development and general and administrative activities. Throughout fiscal year 2021, the Company continued to prioritize its main ADXS-503 product candidate while winding down its legacy studies and reducing its annual operating expenses by approximately $4.7 million, or nearly 18%.
Fiscal Year 2021 Financial Information
Research and development expenses for fiscal year 2021 were $10.6 million, compared with $15.6 million for fiscal year 2020. The $5.0 million decrease was primarily attributable to decreases in clinical, laboratory and personnel costs as a result of the winding down of several legacy studies.
General and administrative expenses for fiscal year 2021 were $11.5 million, compared to $11.1 million for fiscal year 2020.
The net loss for the fiscal year ended October 31, 2021 was $17.9 million or $0.14 per share based on approximately 129 million weighted average shares outstanding. This compares with a net loss for fiscal year 2020 of $26.5 million or $0.43 per share based on approximately 61 million weighted average shares outstanding.
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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 risks associated with being listed on the OTCQX; the outcome of any legal proceedings that may be instituted against the Company; the Company’s history of net operating losses and uncertainty regarding its ability to achieve profitability; 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
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CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share data)
| 2021 | 2020 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 41,614 | $ | 25,178 | ||||
| Deferred expenses | - | 1,808 | ||||||
| Prepaid expenses and other current assets | 1,643 | 865 | ||||||
| Total current assets | 43,257 | 27,851 | ||||||
| Property and equipment (net of accumulated depreciation) | 118 | 2,393 | ||||||
| Intangible assets (net of accumulated amortization) | 3,354 | 3,261 | ||||||
| Operating right-of-use asset (net of accumulated amortization) | 40 | 4,839 | ||||||
| Other assets | 11 | 182 | ||||||
| Total assets | $ | 46,780 | $ | 38,526 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 87 | $ | 410 | ||||
| Accrued expenses | 2,836 | 1,737 | ||||||
| Current portion of operating lease liability | 28 | 962 | ||||||
| Deferred revenue | - | 165 | ||||||
| Common stock warrant liability | 4,929 | 17 | ||||||
| Total current liabilities | 7,880 | 3,291 | ||||||
| Operating lease liability, net of current portion | 12 | 5,055 | ||||||
| Total liabilities | 7,892 | 8,346 | ||||||
| Contingencies – Note 10 | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, |
- | - | ||||||
| Common stock - |
146 | 78 | ||||||
| Additional paid-in capital | 467,342 | 440,840 | ||||||
| Accumulated deficit | (428,600 | ) | (410,738 | ) | ||||
| Total stockholders’ equity | 38,888 | 30,180 | ||||||
| Total liabilities and stockholders’ equity | $ | 46,780 | $ | 38,526 | ||||
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share data)
| Year Ended |
||||||||
| 2021 | 2020 | |||||||
| Revenue | $ | 3,240 | $ | 253 | ||||
| Operating expenses: | ||||||||
| Research and development expenses | 10,562 | 15,612 | ||||||
| General and administrative expenses | 11,464 | 11,090 | ||||||
| Total operating expenses | 22,026 | 26,702 | ||||||
| Loss from operations | (18,786 | ) | (26,449 | ) | ||||
| Other income (expense): | ||||||||
| Interest income | 5 | 110 | ||||||
| Net changes in fair value of derivative liabilities | 970 | - | ||||||
| Loss on shares issued in settlement of warrants | - | (77 | ) | |||||
| Other expense | (1 | ) | (3 | ) | ||||
| Net loss before income tax benefit | (17,812 | ) | (26,419 | ) | ||||
| Income tax expense | 50 | 50 | ||||||
| Net loss | $ | (17,862 | ) | $ | (26,469 | ) | ||
| Net loss per common share, basic and diluted | $ | (0.14 | ) | $ | (0.43 | ) | ||
| Weighted average number of common shares outstanding, basic and diluted | 129,090,709 | 61,003,839 | ||||||
