News Release

Tevard Biosciences and Zogenix Announce Collaboration to Advance Novel Gene Therapies for Dravet Syndrome and Other Genetic Epilepsies

12.03.20

CAMBRIDGE, Mass. and EMERYVILLE, Calif., Dec. 3, 2020 /PRNewswire/ -- Tevard Biosciences, a privately-held biotechnology company pioneering tRNA-based gene therapies, and Zogenix (Nasdaq: ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, today announced that the companies have entered into a collaboration to identify and develop novel tRNA-based gene therapies for Dravet syndrome and other genetic epilepsies.

Under the collaboration, Tevard will utilize its two unique tRNA-based discovery platforms focused on mRNA Stabilization and Nonsense Codon Suppression to discover and advance novel drug candidates for the treatment of Dravet syndrome and other genetic epilepsies. Zogenix will further develop the candidates through advanced preclinical studies and clinical development, and be responsible for worldwide commercialization.

Zogenix is responsible for funding the collaboration and, under the terms of the agreement, Tevard will receive an initial collaboration payment of $10 million, of which approximately $5 million has previously been paid by Zogenix. Tevard will also receive $5 million in the form of a convertible note. Tevard is also eligible to receive additional development, regulatory and commercial-related milestone payments ranging from $70 million to $100 million for each program, as well as tiered royalties on future net global sales on any commercial products that result from the collaboration.

Tevard's unique tRNA technology platforms are designed to address underlying genetic mutations in a precise and regulated manner through the correction of nonsense mutations and the enhanced production of functional proteins. Together, these approaches hold promise to treat genetic disorders that are not well-suited to conventional gene replacement approaches.

"We are pleased to announce our collaboration with Zogenix, whose commitment to developing new treatments for Dravet syndrome and other genetic epilepsies is unparalleled," said Daniel E. Fischer, Co-founder, President, and Chief Executive Officer at Tevard Biosciences. "Tevard has assembled a team of leading experts focused on developing our breakthrough tRNA-based gene therapy platforms. Our collaboration with Zogenix will advance our mission to bring transformative gene therapy products to those living with Dravet and other rare and severe genetic disorders.

"We are thrilled to be working with an innovative company like Tevard to develop promising next-generation therapies," said Stephen J. Farr, Ph.D., President and Chief Executive Officer of Zogenix. "Through this important new collaboration, we have reinforced our long-term commitment to transforming the lives of rare epilepsy patients and their families, and look forward to sharing updates as our work together progresses."

About Dravet Syndrome
Dravet syndrome is a rare childhood-onset epilepsy marked by frequent debilitating seizures, lifelong developmental and motor impairments, and an increased risk of death (SUDEP). In addition to the catastrophic impact on the patient, the severity and unpredictability of the seizures, coupled with around-the-clock concern for the diagnosed child's safety and well-being, can present significant emotional and logistical challenges for parents and all members of the family.

About Tevard Biosciences
Tevard Biosciences is a privately held biotechnology company pioneering tRNA-based gene therapies to cure rare and severe genetic diseases with limited or no approved treatment options. Tevard was founded by MIT Professor and Whitehead Institute Founding Member Harvey Lodish, Ph.D., with life science entrepreneurs and executives Daniel Fischer and Warren Lammert, fathers of children with Dravet syndrome. The company is developing and applying two novel tRNA-based gene therapy platforms, co-invented by Professor Lodish with Johns Hopkins School of Medicine Professor Jeff Coller, Ph.D. and University of Iowa Professor Chris Ahern, Ph.D., for Dravet syndrome and other rare diseases caused by haploinsufficiency and/or nonsense mutations that are not amenable to traditional approaches to gene therapy. For more information, please visit www.tevard.com.

About Zogenix
Zogenix is a global biopharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company's first rare disease therapy, FINTEPLA® (fenfluramine) oral solution has been approved by the U.S. FDA and received a positive CHMP opinion in Europe for the treatment of seizures associated with Dravet syndrome, a rare, severe childhood onset epilepsy. The company has two additional late-stage development programs underway: one for FINTEPLA for the treatment of seizures associated with Lennox-Gastaut syndrome, a different rare childhood-onset epilepsy and another for MT1621, an investigational novel substrate enhancement therapy for the treatment of TK2 deficiency, a rare genetic disorder. MT1621 is being developed through Modis Therapeutics, a Zogenix company.

Forward Looking Statements
Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed," and similar expressions are intended to identify forward-looking statements. These statements include the potential that the use tRNA-based discovery platforms will result in the discovery and advancement novel drug candidates for the treatment of genetic epilepsies; and Zogenix's intention to develop any drug candidates discovered through tRNA-based discovery platforms. These statements are based on Zogenix's current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in Zogenix's business, including, uncertainties related to pharmaceutical product development, including whether any drug candidate will be discovered; results from preclinical or clinical studies may not support the continued development or commercialization of any discovered drug candidate; delays or disruptions in Zogenix's or Tevard's business operations due to the COVID-19 pandemic and other risks described in Zogenix's prior press releases as well as in public periodic filings with the U.S. Securities & Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

CONTACTS:

Tevard Biosciences 
Investors and Media 
Karen L. Bergman for Tevard
+1 (650) 575-1509
karen@tevard.com

Zogenix
Melinda Baker
Senior Director, Corporate Communications
+1 (510) 788-8732
corpcomms@zogenix.com

Investors
Brian Ritchie
Managing Director, LifeSci Advisors LLC
+1 (212) 915-2578
britchie@lifesciadvisors.com

Media
Stefanie Tuck
Vice President, Porter Novelli
+1 (978) 390-1394
stefanie.tuck@porternovelli.com

SOURCE Tevard Biosciences