ADXS-503

Two biotechs are looking to merge early next year, and as negotiations are ongoing, investors still need to sign off on the deal. Oncology-focused Advaxis is in the early stages of merging with Ayala, a biotech incorporated in Delaware that has its primary operations located in Israel. Advaxis CEO Ken Berlin told investors and analysts in a conference call Wednesday morning that he had reviewed “a number of business development opportunities to determine how best to advance Advaxis to a later stage company,” adding that the biotech believes the merger with Ayala is the best way to go about it. Berlin tells Endpoints News that the plan is to have everything sorted out within 90-120 days, or the end of January — and the merger still depends on whether Ayala’s shareholders sign off on the deal. How it will work with having two companies on Nasdaq, under tickers $ADXS and $AYLA , is that Ayala, a penny stock biotech and down 24% Wednesday morning, would delist. While it will list on the OTCQX once the merger is effective, the final goal is for the combined company to be listed on Nasdaq. However, the companies noted that going onto Nasdaq is not guaranteed. Shares of Advaxis, a penny stock territory biotech with shares over $2 each, shot up 16% Wednesday morning before tempering back down to an 8% increase. Ayala shareholders will get a combined 62.5% of the new company, while Advaxis shareholders get the remaining 37.5%. Berlin says these things are all negotiated. “So they think they’re bringing a great asset — and they are — and they should get value for that,” Berlin noted, adding that part of the negotiation included asking what it would have taken for Ayala to raise the $20 million Advaxis already had on hand. What the combined company will be going after, once everything is all said and done, is AL102, a lead program Ayala is bringing to the table to treat desmoid tumors. It’s also the same type of tumor SpringWorks is targeting, recently raising $225 million via private placement and presenting info at ESMO earlier this year. Ayala CEO Roni Mamluk added on the conference call that Ayala’s drug is currently in a Phase II/III registrational trial called RINGSIDE. And that once the proposed merger is complete, Ayala will keep its operations in Israel. As for how the merger came about, Berlin remained mum, telling Endpoints it was coming in the proxy statement and “that will take time to draft.” Another drug that will be considered an option for the new proposed entity, Berlin told Endpoints, is ADXS-504, an Advaxis vaccine for prostate cancer, which is currently being looked at in a Phase I investigator-sponsored trial, or IST, at Columbia University. Berlin added that the investigator, Mark Stein, has worked with Advaxis programs before, when the biotech had previously partnered with Merck. Berlin added in the meantime that in order to predominantly focus on AL102, Advaxis is winding down ADXS-503, a candidate that was being investigated for NSCLC. Other candidates are options, says Berlin, but AL102 is the primary focus. Advaxis has been in trouble of its own over the years. after securing a $540 million deal with Amgen back in 2016, the FDA put a clinical hold on a Phase I/II trial after a patient death in 2018. Amgen then backed out of the deal later that year. A proposed merger was initially voted on and passed by shareholders with Israeli biotech Biosight, but Advaxis said a second vote for the reverse split portion did not pass with shareholders.

Announced completion of first dose level and enrollment initiation for second dose level in investigator-sponsored study of ADXS-504 in biochemically recurrent prostate cancer Cash runway extends into fiscal third quarter of 2024 MONMOUTH JUNCTION, N.J., Sept. 12, 2022 (GLOBE NEWSWIRE) -- Advaxis, Inc. (OTCQX: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, today announces its financial results for the third quarter ended July 31, 2022 and provides a business update. Third Quarter Ended July 31, 2022 Financial Results and Recent Key Accomplishments: Announced completion of first dose level in investigator-sponsored study in biochemically recurrent prostate cancer. The preliminary clinical assessment showed that at the first dose level ADXS-504 monotherapy is safe and well tolerated.The company plans to present clinical data and PSA values, for patients in both cohorts at a future medical conference. Announced enrollment initiation for second dose level cohort of investigator-sponsored clinical trial of ADXS-504 (HOT Prostate) in biochemically recurrent prostate cancer at Columbia University. Management Commentary Kenneth A. Berlin, President and Chief Executive Officer of Advaxis said, “We continue to make progress in our development of ADXS-504. We announced that we have completed the first dose level in our investigator-sponsored trial of ADXS-504 in biochemically recurrent prostate cancer and the data suggest that this novel therapeutic is safe and well-tolerated. In addition, we have initiated enrollment for the second dose cohort and look forward to reporting safety and initial clinical data in the first half of 2023.” Mr. Berlin added, “Given the measures we have undertaken to control expenses, we continue to expect that our cash runway will reach into the third fiscal quarter of 2024.” Third Quarter Ended July 31, 2022 Financial Results Research and development expenses for the third quarter of fiscal year 2022 were $2.2 million compared with $1.7 million for the third quarter of fiscal year 2021. The increase of $0.5 million was primarily attributable to patient recruitment and manufacturing costs associated with our ADXS-503 clinical trial program. General and administrative expenses for the three months ended July 31, 2022 were approximately $2.1 million, compared to $2.7 million in the same three-month period in 2021. The decrease of $0.6 million primarily relates to legal and consulting fees with a previously proposed merger transaction and proxy solicitation fees in the prior period, partially offset by settlements from stockholder demand letters in the current period. As of July 31, 2022, the Company had approximately $28.2 million in cash and cash equivalents. 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. 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 for the year ended October 31, 2021, filed on February 14, 2022, and its subsequent 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, LLC212.915.2564tim@lifesciadvisors.com ADVAXIS, INC.CONDENSED CONSOLIDATED BALANCE SHEETS(In thousands, except share and per share data) July 31, 2022 October 31, 2021 (Unaudited) ASSETS Current assets: Cash and cash equivalents $28,150 $41,614 Prepaid expenses and other current assets 1,667 1,643 Total current assets 29,817 43,257 Property and equipment (net of accumulated depreciation) 73 118 Intangible assets (net of accumulated amortization) 181 3,354 Operating right-of-use asset (net of accumulated amortization) 19 40 Other assets 11 11 Total assets $30,101 $46,780 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable $90 $87 Accrued expenses 1,510 2,836 Current portion of operating lease liability 19 28 Common stock warrant liability 287 4,929 Total current liabilities 1,906 7,880 Operating lease liability, net of current portion - 12 Total liabilities 1,906 7,892 Contingencies – Note 8 Series D convertible preferred stock- $0.001 par value; 1,000,000 shares authorized, issued and outstanding at July 31, 2022 and October 31, 2021. - - Stockholders’ equity: Preferred stock, $0.001 par value; 5,000,000 shares authorized, 0 shares issued and outstanding at July 31, 2022 and October 31, 2021. - - Common stock - $0.001 par value; 170,000,000 shares authorized, 1,815,951 and 1,820,452 shares issued and outstanding at July 31, 2022 and October 31, 2021. 2 2 Additional paid-in capital 466,561 467,486 Accumulated deficit (438,368) (428,600)Total stockholders’ equity 28,195 38,888 Total liabilities and stockholders’ equity $30,101 $46,780 ADVAXIS, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)(In thousands, except share and per share data) Three Months EndedJuly 31, 2022 2021 Revenue $- $250 Operating expenses: Research and development expenses 2,233 1,703 General and administrative expenses 2,053 2,678 Intangible 3,005 - Total operating expenses 7,291 4,381 Loss from operations (7,291) (4,131) Other income (expense): Interest income, net 50 1 Net changes in fair value of derivative liabilities 276 846 Other (expense) income 2 - Net loss before income taxes (6,963) (3,284) Income tax expense - 50 Net loss $(6,963) $(3,334) Net loss per common share, basic and diluted $(3.83) $(1.83) Weighted average number of common shares, basic and diluted 1,817,761 1,820,452