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Advaxis Reports First Quarter Ended January 31, 2021 Financial Results and Provides a Business Update

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Continued enrollment in expanded ADXS-503 HOT program in NSCLC to explore potential to enhance and/or restore sensitivity to checkpoint inhibitors

ADXS-503 Phase 1/2 trial data presented at SITC demonstrated disease control rate of 67% and overall response rate of 17% in first six evaluable patients with immediate prior progression on KEYTRUDA®

$9.2M public offering strengthens balance sheet for continued execution

PRINCETON, N.J., March 16, 2021 (GLOBE NEWSWIRE) -- Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products today announces its financial results for the first quarter ended January 31, 2021 and provides a business update.

First Quarter Ended January 31, 2021 Financial Results and Recent Key Accomplishments:

  • 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 2020 Society for Immunotherapy of Cancer (SITC) Annual Meeting
    ° Disease control rate of 67% and overall response rate of 17% in first six evaluable patients with immediate prior progression on KEYTRUDA®. The first two patients treated in Part B combination arm that had achieved stable disease (SD) and partial response (PR) remain on treatment for 10 and 8 months, respectively
    ° Biomarker data across 9 patients across trial arms confirmed on-mechanism activation of innate and adaptive immune responses to ADXS-503 with transient elevation of immune-modulatory cytokines, activation of cytotoxic -and/or memory CD8+ T cells as well as 100% efficient priming by ADXS-503
    ° Across trial arms, ADXS-503 appeared safe and well tolerated as a monotherapy and in combination with KEYTRUDA® with no added toxicities from combination therapy

  • Announced upcoming presentation at the American Association for Cancer Research (AACR) 2021 Annual meeting, in collaboration with Precision 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 receipt of funding milestone payment under ADXS-HER2 licensing agreement with OS Therapies

  • Announced closing of $9.2 million public offering of common stock and warrants, with proceeds being used to fund continued development and expansion of our product pipeline

Management Commentary

“We are encouraged by the growing body of evidence that suggest ADXS-503 has the potential to synergistically enhance and/or restore sensitivity to checkpoint inhibitors,” said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. “Based on our encouraging data, we are prioritizing the ongoing and recently expanded ADXS-503 trial in diverse treatment settings for NSCLC, and will remain focused on continued clinical execution. We look forward to our presentation at AACR, which will further expand upon the previously reported on-mechanism innate and adaptive immune stimulation which we believe are driving meaningful and durable clinical benefit for patients treated with ADXS-503. Our strengthened balance sheet leaves us well positioned to continue progress with our off-the-shelf neoantigen immunotherapy ADXS-HOT program, including our planned expansion into prostate cancer with ADXS-504, and we look forward to providing study updates in the coming months.”

First Quarter Ended January 31, 2021 Financial Results

Research and development expenses for the first quarter of fiscal year 2021 were $2.6 million, compared with $4.9 million for the first quarter of fiscal year 2020. The reduction of $2.3 million was primarily attributable to the substantial reduction in costs associated with the winding down of clinical studies that have been discontinued.

General and administrative expenses for the three months ended January 31, 2021 were approximately unchanged at $3 million, compared to $3 million in the same three-month period in 2020.

As of January 31, 2021, the Company had approximately $33.3 million in cash and cash equivalents. The Company believes this is sufficient capital to fund its obligations, as they become due, in the ordinary course of business until May 2022.

About Advaxis, Inc.
Advaxis, Inc. is a clinical-stage biotechnology company focused on the development and commercialization of proprietary Lm-based antigen delivery products. These immunotherapies are based on a platform technology that utilizes live attenuated Listeria monocytogenes (Lm) bioengineered to secrete antigen/adjuvant fusion proteins. These Lm-based strains are believed to be a significant advancement in immunotherapy as they integrate multiple functions into a single immunotherapy and are designed to access and direct antigen presenting cells to stimulate anti-tumor T cell immunity, activate the immune system with the equivalent of multiple adjuvants, and simultaneously reduce tumor protection in the tumor microenvironment to enable T cells to eliminate tumors.

To learn more about Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook and YouTube.

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 SEC, including, without limitation, its Annual Report on Form 10-K, filed on January 22, 2021, and its periodic reports on Form 10-Q and Form 8-K. Any statements contained herein that do not describe historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results, performance and achievements to differ materially from those discussed in such forward-looking statements. The Company 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., Kenilworth, N.J., USA.

Contact:
Tim McCarthy, LifeSci Advisors, LLC
212.915.2564
tim@lifesciadvisors.com

ADVAXIS, INC.
CONDENSED BALANCE SHEETS
(In thousands, except share and per share data)


January 31,
2021
(Unaudited)



October 31,
2020

ASSETS

Current Assets:

Cash and cash equivalents

$

33,318

$

25,178

Deferred expenses

1,602

1,808

Prepaid expenses and other current assets

608

865

Total current assets

35,528

27,851

Property and equipment (net of accumulated depreciation)

2,189

2,393

Intangible assets (net of accumulated amortization)

3,404

3,261

Operating right-of-use asset (net of accumulated amortization)

4,644

4,839

Other assets

182

182

Total assets

$

45,947

$

38,526

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities:

Accounts payable

$

399

$

410

Accrued expenses

2,142

1,737

Common stock warrant liability

44

17

Current portion of operating lease liability

992

962

Deferred revenue

-

165

Total current liabilities

3,577

3,291

Operating lease liability, net of current portion

4,795

5,055

Total liabilities

8,372

8,346

Commitments and contingencies – Note 9

Stockholders’ equity:

Preferred stock, $0.001 par value; 5,000,000 shares
authorized; Series B Preferred Stock; 0 shares issued and
outstanding at January 31, 2021 and October 31, 2020;
Liquidation preference of $0 at January 31, 2021 and
October 31, 2020

-

-

Common stock - $0.001 par value; 170,000,000 shares
authorized, 116,130,688 and 78,074,023 shares issued and
outstanding at January 31, 2021 and October 31, 2020,
respectively

116

78

Additional paid-in capital

452,174

440,840

Accumulated deficit

(414,715

)

(410,738

)

Total stockholders’ equity

37,575

30,180

Total liabilities and stockholders’ equity

$

45,947

$

38,526

The accompanying notes should be read in conjunction with the financial statements.


ADVAXIS, INC.

CONDENSED STATEMENTS OF OPERATIONS (Unaudited)
(In thousands, except share and per share data)

Three Months Ended
January 31,

2021

2020

Revenue

$

1,615

$

3

Operating expenses:

Research and development expenses

2,570

4,859

General and administrative expenses

3,008

3,030

Total operating expenses

5,578

7,889

Loss from operations

(3,963

)

(7,886

)

Other income (expense):

Interest income, net

1

66

Net changes in fair value of derivative liabilities

(27

)

(37

)

Other income

12

-

Net loss before benefit for income taxes

(3,977

)

(7,857

)

Income tax expense

-

-

Net loss

$

(3,977

)

$

(7,857

)

Net loss per common share, basic and diluted

$

(0.05

)

$

(0.15

)

Weighted average number of common shares outstanding,
basic and diluted

83,943,982

51,747,246

The accompanying notes should be read in conjunction with the financial statements.


ADVAXIS, INC.

CONDENSED STATEMENTS OF CASH FLOWS (Unaudited)
(In thousands)

Three Months Ended
January 31,

2021

2020

OPERATING ACTIVITIES

Net loss

$

(3,977

)

$

(7,857

)

Adjustments to reconcile net loss to net cash used in operating activities:

Stock compensation

236

242

Loss on change in value of warrants

27

37

Loss on disposal of property and equipment

12

-

Abandonment of intangible assets

-

232

Depreciation expense

192

229

Amortization expense of intangible assets

67

91

Amortization of right-of-use asset

195

181

Change in operating assets and liabilities:

Prepaid expenses and other current assets

463

789

Other assets

-

1

Accounts payable and accrued expenses

394

(1,462

)

Deferred revenue

(165

)

-

Operating lease liabilities

(230

)

(191

)

Net cash used in operating activities

(2,786

)

(7,708

)

INVESTING ACTIVITIES

Cost of intangible assets

(210

)

(238

)

Net cash used in investing activities

(210

)

(238

)

FINANCING ACTIVITIES

Net proceeds of issuance of common stock

8,550

9,737

Warrant exercise

2,586

-

Proceeds from employee stock purchase plan

-

2

Net cash provided by financing activities

11,136

9,739

Net increase in cash and cash equivalents

8,140

1,793

Cash and cash equivalents at beginning of period

25,178

32,363

Cash and cash equivalents at end of period

$

33,318

$

34,156

SUPPLEMENTAL CASH FLOW INFORMATION

Cash paid for taxes

$

-

$

-

SUPPLEMENTAL DISCLOSURE OF NON-CASH AND
FINANCING ACTIVITIES

Warrant liability reclassified into equity

-

2

Amounts accrued for offering costs

-

109

The accompanying notes should be read in conjunction with the financial statements.