Advaxis Reports First Quarter Ended January 31, 2022 Financial Results and Provides a Business Update
Presented Updated Clinical Data from Ongoing Phase 1/2 Trial of ADXS-503 in NSCLC and Upcoming Milestones
Priced Offering of
First Quarter Ended
- Announced that the Company’s common stock would begin trading on the OTCQX® Best Market (“OTCQX”) on
December 23, 2021 , under the symbol ADXS - Announced updated clinical data from the Company’s ongoing Phase 1/2 study evaluating ADXS-503 in combination with KEYTRUDA® (pembrolizumab)
- In Part B of the study, with ADXS-503 as an add on therapy for patients failing KEYTRUDA®, a second patient showed partial response (PR), bringing the overall response rate to 15.4% (2/13) and the disease control rate to 46% (6/13). Clinical benefit was durable, with two patients sustaining PR for 23 and 6 months, respectively, while three maintained stable disease (SD) for 15, 6 and 4 months, respectively. Another patient with SD is still under evaluation
- Combination therapy was well tolerated with no dose-limiting-toxicity (DLT) or added toxicity of the two drugs
- Patients achieving clinical benefit include those with PD-L1 expression ≥50%, secondary resistance disease to KEYTRUDA® and those with proliferation and/or activation of NK cells and CD8+ T cells within the initial weeks of therapy
- In Part C, with ADXS-503 being dosed in combination with KEYTRUDA®, preliminary data show disease control rate of 67% (2/3). The two patients sustained SD for 3 and 11 months, respectively
- Announced offering pricing of
$5 million of convertible redeemable Series D preferred stock through a private placement- Each share has a purchase price of
$4.75 , representing an original issue discount (“OID”) of 5% of the stated value. The shares of Series D preferred stock are convertible into shares of the Company’s common stock, upon the occurrence of certain events, determined by dividing the$5.00 stated value of a share of preferred stock by the conversion price of$0.25 , subject to adjustment - The Series D preferred stockholders may exercise the option to convert the shares at any time following the receipt of the stockholder approval for a reverse stock split
- Each share has a purchase price of
- Upcoming milestones
- The results of translational studies, including flow cytometry, ELISPOT, cytokine/chemokine levels, mutational analysis, MSI TMB and cfDNA and their clinical correlates, will be presented at an upcoming medical meeting
- The results of translational studies, including flow cytometry, ELISPOT, cytokine/chemokine levels, mutational analysis, MSI TMB and cfDNA and their clinical correlates, will be presented at an upcoming medical meeting
Management Commentary
“The impressive initial results from our on-going phase 1/2 study suggest that ADXS-503 has the capacity to restore responsiveness to check point inhibitors in patients who were no longer benefiting from these medications,” said
First Quarter Ended
Research and development expenses for the first quarter of fiscal year 2022 were
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, 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
cautions readers not to place undue reliance on any forward-looking statements, which speak only as of the date they were made.
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.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.,
Contact:
212.915.2564
tim@lifesciadvisors.com
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share data)
| (Unaudited) | ||||||||||
| ASSETS | ||||||||||
| Current assets: | ||||||||||
| Cash and cash equivalents | $ | 36,480 | $ | 41,614 | ||||||
| Restricted cash | 5,250 | - | ||||||||
| Prepaid expenses and other current assets | 1,386 | 1,643 | ||||||||
| Total current assets | 43,116 | 43,257 | ||||||||
| Property and equipment (net of accumulated depreciation) | 100 | 118 | ||||||||
| Intangible assets (net of accumulated amortization) | 3,238 | 3,354 | ||||||||
| Operating right-of-use asset (net of accumulated amortization) | 33 | 40 | ||||||||
| Other assets | 11 | 11 | ||||||||
| Total assets | $ | 46,498 | $ | 46,780 | ||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||||
| Current liabilities: | ||||||||||
| Accounts payable | $ | 345 | $ | 87 | ||||||
| Accrued expenses | 2,131 | 2,836 | ||||||||
| Current portion of operating lease liability | 29 | 28 | ||||||||
| Preferred stock redemption liability | 87 | - | ||||||||
| Common stock warrant liability | 1,127 | 4,929 | ||||||||
| Total current liabilities | 3,719 | 7,880 | ||||||||
| Operating lease liability, net of current portion | 5 | 12 | ||||||||
| Total liabilities | 3,724 | 7,892 | ||||||||
| Contingencies – Note 10 | ||||||||||
| Series D convertible preferred stock- |
4,225 | - | ||||||||
| Stockholders’ equity: | ||||||||||
| Preferred stock, |
- | - | ||||||||
| Common stock - |
146 | 146 | ||||||||
| Additional paid-in capital | 467,368 | 467,342 | ||||||||
| Accumulated deficit | (428,965 | ) | (428,600 | ) | ||||||
| Total stockholders’ equity | 38,549 | 38,888 | ||||||||
| Total liabilities and stockholders’ equity | $ | 46,498 | $ | 46,780 | ||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
(In thousands, except share and per share data)
| Three Months Ended |
||||||||||
| 2022 | 2021 | |||||||||
| Revenue | $ | - | $ | 1,615 | ||||||
| Operating expenses: | ||||||||||
| Research and development expenses | 1,654 | 2,570 | ||||||||
| General and administrative expenses | 2,510 | 3,008 | ||||||||
| Total operating expenses | 4,164 | 5,578 | ||||||||
| Loss from operations | (4,164 | ) | (3,963 | ) | ||||||
| Other income (expense): | ||||||||||
| Interest income, net | 1 | 1 | ||||||||
| Net changes in fair value of derivative liabilities | 3,802 | (27 | ) | |||||||
| Other (expense) income | (4 | ) | 12 | |||||||
| Net loss before income taxes | (365 | ) | (3,977 | ) | ||||||
| Income tax expense | - | - | ||||||||
| Net loss | $ | (365 | ) | $ | (3,977 | ) | ||||
| Net loss per common share, basic and diluted | $ | (0.00 | ) | $ | (0.05 | ) | ||||
| Weighted average number of common shares, basic and diluted | 145,638,459 | 83,943,982 | ||||||||
Source: Advaxis, Inc.