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Advaxis Announces Licensing Agreement with Knight Therapeutics and Raises $25 Million Through Direct Investments from Knight and Sectoral Asset Management

Licensing agreement provides Knight commercial rights in Canada to Advaxis’s product portfolio including axalimogene filolisbac (ADXS-HPV), ADXS-PSA and ADXS-HER2

Advaxis is eligible to receive up to $30 million in milestone payments from Knight

PRINCETON, N.J. and MONTREAL, QC, August 26, 2015 — Advaxis, Inc. (NASDAQ:ADXS) (“Advaxis” or the “Company”), a clinical-stage biotechnology company developing cancer immunotherapies, today announced that the Company has entered into a licensing agreement with Knight Therapeutics Inc. (TSX: GUD) (“Knight”), a Canadian-based specialty pharmaceutical company focused on acquiring, in-licensing, selling and marketing innovative prescription and over-the-counter pharmaceutical products, to commercialize in Canada Advaxis’s product portfolio including its three lead drug candidates: axalimogene filolisbac (ADXS-HPV) for human papilloma virus (HPV)-associated cancers, ADXS-PSA for prostate cancer and ADXS-HER2 for HER2 expressing solid tumors.  

In connection with the licensing agreement, Knight is purchasing directly from Advaxis 359,454 shares at $13.91 per share, which represents a 7 percent premium to the price of Advaxis’s common stock at market close on August 25, 2015. In addition, Sectoral Asset Management, a leading Canadian-based global healthcare investment advisor, is purchasing 1,437,815 shares at $13.91 per share directly from Advaxis on behalf of its clients. The combined gross proceeds to Advaxis from these direct investments is $25 million.

“We are extremely gratified to, in one transaction, monetize a non-core market with a well-established local partner, while simultaneously increasing our cash balance under very favorable terms,” said Daniel J. O’Connor, President and Chief Executive Officer of Advaxis. “We have added both a key strategic partner in Knight and a top-tier healthcare institutional investor in Sectoral Asset Management. The license agreement with Knight is consistent with our strategy of focusing our resources in our core geographies.”

Under the terms of the licensing agreement, Knight will be responsible for all commercial activities related to Advaxis current and future products, including axalimogene filolisbac, ADXS-PSA and ADXS-HER2, in Canada. Advaxis is eligible to receive double digit royalty as well as sales milestones.

“We believe Advaxis’s technology has significant potential to treat a multitude of cancers,” said Jonathan Ross Goodman, President and Chief Executive Officer of Knight. “This agreement, as well as our investment in the Company, are representative of our confidence in Advaxis’s future prospects. Upon approval, Knight looks forward to leveraging our local market expertise to maximize the commercial value of axalimogene filolisbac, ADXS-PSA and ADXS-HER2 in Canada.” 

“Sectoral Asset Management is pleased to make this significant investment in Advaxis on behalf of our clients,” said Stephan Patten, Deputy Chief Investment Officer of Sectoral Asset Management. “We believe the Company’s promising Lm Technology™ cancer immunotherapy platform, robust clinical pipeline and strong management team with a track record of execution combine to establish a compelling value proposition for Advaxis, and look forward to tracking the Company’s progress going forward.”    


About Axalimogene Filolisbac

Axalimogene filolisbac (ADXS-HPV) is Advaxis's lead Lm Technology™ immunotherapy candidate for the treatment of HPV-associated cancers and is in clinical trials for three potential indications: invasive cervical cancer, head and neck cancer, and anal cancer. In a completed randomized Phase 2 study in recurrent/refractory cervical cancer, axalimogene filolisbac showed apparent prolonged survival, objective tumor responses, and a manageable safety profile alone or in combination with chemotherapy, supporting further development of the Company's Lm Technology™.

About ADXS-PSA

ADXS-PSA is an Lm Technology™ immunotherapy designed to target the prostate-specific antigen (PSA) associated with prostate cancer. ADXS-PSA is in clinical development both as a monotherapy and in combination with immune checkpoint inhibitors for the treatment of metastatic castration-resistant prostate cancer (mCRPC).

About ADXS-HER2

ADXS-HER2 is an Lm Technology™ immunotherapy being developed for the targeted treatment of HER2 expressing cancers. ADXS-HER2 has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of osteosarcoma. Advaxis is developing ADXS-HER2 for both human and animal-health, and has seen encouraging data in canine osteosarcoma, which is considered a model for human osteosarcoma. Advaxis licensed ADXS-HER2 and three other immunotherapy constructs to Aratana Therapeutics, Inc. for the development of pet therapeutics.


About Advaxis, Inc.

Located in Princeton, N.J., Advaxis, Inc. is a clinical-stage biotechnology company developing multiple cancer immunotherapies based on its proprietary Lm Technology™. The Lm Technology™, using bioengineered live attenuated Listeria monocytogenes bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T-cells directed against a cancer antigen and neutralize Tregs and myeloid-derived suppressor cells (MDSCs), that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis's lead Lm Technology™ immunotherapy, axalimogene filolisbac, targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three potential indications: Phase II in invasive cervical cancer, Phase I/II in head and neck cancer, and Phase I/II in anal cancer. The U.S. Food and Drug Administration (FDA) has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings. For additional information on Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook, YouTube and Google+.

About Knight Therapeutics Inc.

Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian and select international markets. Knight's shares trade on TSX under the symbol GUD. For more information about Knight Therapeutics Inc., please visit the company's web site at www.gud-knight.com or www.sedar.com.

About Sectoral Asset Management

Sectoral Asset Management is an SEC-registered investment advisor based in Montreal whose focus is managing global healthcare equity portfolios. Sectoral has one of the world’s longest track records in managing biotech equities and is a sub-advisor of numerous healthcare and biotech funds offered by partners in Europe, North America, and Asia.


Advaxis Forward-Looking Statements

This news release contains forward-looking statements, including, but not limited to: statements regarding Advaxis's ability to develop the next generation of cancer immunotherapies; and the safety and efficacy of Advaxis's proprietary immunotherapy, axalimogene filolisbac, ADXS-PSA and ADXS-HER2. These forward-looking statements are subject to a number of risks, including the risk factors set forth from time to time in Advaxis's SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2014, which is available at http://www.sec.gov. Advaxis undertakes no obligation to publicly release the result of any revision to these forward-looking statements, which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements.

Knight Forward-Looking Statement

This document contains forward-looking statements for Knight and its subsidiaries. These forward looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Knight considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared, but cautions the reader that these assumptions regarding future events, many of which are beyond the control of Knight and its subsidiaries, may ultimately prove to be incorrect. Factors and risks, which could cause actual results to differ materially from current expectations are discussed in Knight’s Annual Report and in Knight’s Annual Information Form for the year ended December 31, 2014. Knight disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information or future events, except as required by law.

Sectoral Forward Looking Statement 

This news release contains certain statements that may be deemed forward-looking statements. Statements in this presentation are based on certain assumptions, analyses of historical trends, current conditions, expected future developments and other factors. These forward looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Views as expressed herein are made only as at the date of this press release and are subject to change without notice.


CONTACTS: 

Advaxis, Inc. Contact: 
Advaxis, Inc. 
Greg Mayes, Executive Vice President and COO 
This email address is being protected from spambots. You need JavaScript enabled to view it.  
609.452.9813 ext. 102

Advaxis, Inc. Media Contact: 
JPA Health Communications 
Carolyn Sobczyk 
This email address is being protected from spambots. You need JavaScript enabled to view it.  
402.718.3974

Knight Therapeutics Inc. Contact: 
Knight Therapeutics Inc.
Jeffrey Kadanoff, P.Eng., MBA, Chief Financial Officer
This email address is being protected from spambots. You need JavaScript enabled to view it.  
514-484-4831

 

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