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Tocagen Closes Previously Announced License Agreement with ApolloBio to Develop and Commercialize Toca 511 & Toca FC in Greater China

SAN DIEGO and BEIJING, July 9, 2018 /PRNewswire/ -- Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, and Beijing Apollo Venus Biomedical Technology Limited, an affiliate of ApolloBio Corp., a biopharmaceutical company focused on oncology (collectively, "ApolloBio"), today announced the closing of an agreement providing ApolloBio with the exclusive right to develop and commercialize Toca 511 & Toca FC within the greater China region. ApolloBio has garnered all regulatory approvals for the agreement and paid Tocagen the upfront payment of $16 million.

Tocagen Inc. (PRNewsfoto/Tocagen Inc.)

Under the terms of the agreement signed with ApolloBio in April 2018, Tocagen is also eligible to receive potential payments of $4 million in near-term development milestones, including a milestone for the completion of enrollment in the ongoing Phase 3 Toca 5 study. Tocagen will be eligible for additional future payments totaling up to $111 million upon meeting certain development and commercial milestones. In addition, the agreement provides for low double-digit tiered royalty payments based on net sales. ApolloBio will be responsible for all development and commercialization costs in the licensed territory.

"We're pleased to have completed our strategic partnership agreement with ApolloBio, allowing us to expand the global commercial opportunity for Toca 511 & Toca FC amidst important recent developments in China to facilitate patient access to medical innovations," said Marty Duvall, chief executive officer of Tocagen. "This partnership also strengthens Tocagen's cash position to fuel our pivotal Phase 3 Toca 5 trial and our pipeline-expanding R&D efforts."

"We are eager to collaborate closely with Tocagen and advance the development of Toca 511 & Toca FC in greater China," said Dr. Weiping Yang, chief executive officer of ApolloBio. "This partnership is an example of our commitment to bringing novel immuno-oncology treatments to the large patient population in China as soon as possible."

About Toca 511 & Toca FC

Tocagen's lead product candidate is a two-part cancer-selective immunotherapy comprised of an investigational biologic, Toca 511 and an investigational small molecule, Toca FC. Toca 511 (vocimagene amiretrorepvec) is a retroviral replicating vector (RRV) that selectively infects cancer cells and delivers a gene for the enzyme, cytosine deaminase (CD). Through this targeted delivery, infected cancer cells carry the CD gene and produce CD. Toca FC is an orally administered, extended-release formulation of the prodrug, 5-fluorocytosine (5-FC), which is converted into an anti-cancer drug, 5-fluorouracil (5-FU), when it encounters CD. 5-FU kills cancer cells and immune-suppressive myeloid cells in the tumor microenvironment resulting in anti-cancer immune activation and subsequent tumor killing.

About ApolloBio Corp.

ApolloBio Corp. is an innovative Chinese biomedical company committed to research, development and commercialization of innovative new medicines, accessing such new medicines through in-licensing and in-house development. ApolloBio is focused on pharmaceutical products with significant market potential in China in the field of oncology; providing efficient access for American biomedical companies to enter into the Chinese market; and aiming to bring the newest and best medicines across the globe to the Chinese patients. For more information, visit www.apollobio.com.

About Tocagen Inc.

Tocagen is a clinical-stage, cancer-selective gene therapy company developing first-in-class, broadly applicable product candidates designed to activate a patient's immune system against their own cancer. Tocagen's lead investigational product candidate, Toca 511 & Toca FC, is under evaluation in a pivotal Phase 3 trial for recurrent high grade glioma (HGG), a disease with significant unmet medical need. The U.S. Food and Drug Administration (FDA) has granted Toca 511 & Toca FC Breakthrough Therapy Designation for the treatment of recurrent HGG and the European Medicines Agency (EMA) has granted Toca 511 PRIME (PRIority MEdicines) designation for the treatment of glioma. For more information about Tocagen, visit www.tocagen.com.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the payments we expect to receive from ApolloBio under the license agreement, including the timing and amounts of such payments, ApolloBio's development and regulatory capabilities and resources, the development and regulatory environment for oncology candidates and gene therapy candidates in the greater China region, and the market potential for oncology products and gene therapy products in the greater China region. Risks that contribute to the uncertain nature of the forward-looking statements include: ApolloBio's ability to obtain required currency exchange and other approvals from PRC authorities for payments under the agreement; the uncertain timing of obtaining such approvals; regulatory developments in the greater China region, the United States and other countries; ApolloBio's ability to execute on its strategy, including the availability to ApolloBio of sufficient capital for such purpose; the success, cost and timing of ApolloBio obtaining approval to import Toca 511 and Toca FC manufactured outside of the greater China region for use in clinical trials or for commercial distribution; tariffs or restrictions that People's Republic of China (PRC) authorities may impose on the import of pharmaceutical products manufactured outside of the greater China region; the amount of PRC withholding tax and value added tax that ApolloBio will be required to deduct from any payments to us under the agreement; the extent, if any, to which we are able to recover any such withheld amounts; ApolloBio's diligence obligations and resource commitments with respect to the development and commercialization of other products in-licensed by ApolloBio from third parties and ApolloBio's own internally-developed products; timing, cost and success of our clinical trials and planned clinical trials of Toca 511 & Toca FC, including the ongoing Phase 3 clinical trial; timing and success of obtaining FDA approval of Toca 511 & Toca FC; and the ability of our R&D efforts to expand our pipeline and the costs of such efforts. These and other risks and uncertainties are described more fully under the caption "Risk Factors" and elsewhere in Tocagen's filings and reports with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Tocagen undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Media Contact:
Pam Lord
Canale Communications
pam@canalecomm.com

Investor Contact:
Elizabeth Broder
Endurance Advisors
ebroder@enduranceadvisors.com

 

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SOURCE Tocagen Inc.