Audentes Therapeutics to Participate in Upcoming Investor Conferences

On October 1, 2019 Audentes Therapeutics, Inc. (Nasdaq: BOLD), a leading AAV-based genetic medicines company focused on developing and commercializing innovative products for serious rare neuromuscular diseases, reported that Natalie Holles, President and Chief Operating Officer, will participate in the following investor conferences in October (Press release, Audentes Therapeutics, OCT 1, 2019, View Source [SID1234539986]):

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Chardan 3rd Annual Genetic Medicines Conference
Fireside Chat: Monday, October 7, 2019, at 10:30am ET
New York, New York

Jefferies Gene Therapy/Editing Summit
Fireside Chat: Tuesday, October 8, 2019, at 9:10am ET
Panel: "Manufacturing, Dose, and Durability in Gene Therapy," Tuesday, October 8, 2019, at 10:20am ET
New York, New York

To access live webcasts of the fireside chats, please visit the Events & Presentations page within the Investors + Media section of the Audentes website. Following each conference, a replay of the live webcast will be available on the Audentes website for approximately 30 days. There is no webcast available for the Manufacturing, Dose, and Durability in Gene Therapy panel at the Jefferies Gene Therapy/Editing Summit.

Vertex Appoints Carmen Bozic, M.D., as New Chief Medical Officer and Nia Tatsis, Ph.D., as New Chief Regulatory Officer

On October 1, 2019 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) reported that Carmen Bozic, M.D., has been appointed as the company’s Executive Vice President, Global Medicines Development and Medical Affairs. Dr. Bozic will assume the additional role of Chief Medical Officer on April 1, 2020 when Reshma Kewalramani, M.D., the company’s current Chief Medical Officer, becomes President and Chief Executive Officer of Vertex (Press release, Vertex Pharmaceuticals, OCT 1, 2019, View Source [SID1234539985]). Dr. Bozic has served as Senior Vice President and Head of Global Clinical Development since May of this year.

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Vertex also announced the appointment of Nia Tatsis, Ph.D., currently Vertex’s Senior Vice President, Global Regulatory Affairs, as Senior Vice President, Chief Regulatory Officer, effective immediately.

"The addition of Carmen and Nia to Vertex’s executive team further strengthens our leadership ranks as we work towards completing our CF journey and bringing new therapies into the clinic in a variety of new disease areas," said Jeffrey Leiden, M.D., Ph.D., Chairman, President and Chief Executive Officer of Vertex.

Dr. Bozic received her M.D. and completed her residency in Internal medicine at McGill University in Montreal, Canada, and then completed a fellowship in Pulmonary and Critical Care Medicine at Brigham and Women’s Hospital in Boston. Since joining Vertex, she has been leading Clinical Development of the company’s cystic fibrosis and alpha-1 antitrypsin deficiency programs, as well as leading Clinical Operations across the pipeline, among other areas. Prior to joining Vertex, Dr. Bozic spent more than 20 years at Biogen, including as Senior Vice President, Global Development. During her tenure at Biogen, she led multiple functions, including Global Clinical Development, Safety, Preclinical Safety, Regulatory, Clinical Operations and Biometrics.

"I am thrilled to take on the leadership of Vertex’s talented Global Medicines Development and Medical Affairs team at such an exciting time for the company," said Dr. Bozic. "Vertex advanced its cystic fibrosis portfolio through the clinic with unprecedented speed and purpose, and now has seven potential therapies in the clinic with the opportunity to transform the treatment of patients with other serious diseases."

Dr. Tatsis received her Ph.D. in Cell and Molecular Biology from the University of Vermont and holds a B.S. in Biology from Temple University. She was a Post-Doctoral Fellow at the Wistar Institute and has held positions of increasing responsibility at pharmaceutical companies including Sanofi, Pfizer, and Wyeth prior to joining Vertex in 2017. Most recently, she was Vice President, Head of Global Regulatory Affairs of the Sanofi Genzyme Business Unit focused on Immunology, Rare Diseases, Multiple Sclerosis and Oncology.

"Vertex is a company that is relentlessly focused on scientific innovation and bringing transformative advances in medicine to patients with serious diseases," said Dr. Tatsis. "We have an outstanding regulatory team and I am honored to lead them in this role as we work to deliver on our mission and strategy."

CRISPR Therapeutics to Present at Upcoming Investor Conferences

On October 1, 2019 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported that members of its senior management team are scheduled to make the following presentations in October (Press release, CRISPR Therapeutics, OCT 1, 2019, View Source [SID1234539984]):

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Chardan’s 3rd Annual Genetic Medicines Conference
Date: Tuesday, October 8, 2019
Presentation: 10:30 a.m. ET
Location: New York, NY

Jefferies Gene Therapy/Editing Summit
Date: Tuesday, October 8, 2019
Panel Discussion: 1:10 p.m. ET
Location: New York, NY

A live webcast of the events will be available on the "Events & Presentations" page in the Investors section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 14 days following the presentation.

Entry into a Material Definitive Agreement

On October 1, 2019, Scilex Pharmaceuticals Inc. ("Scilex"), an indirect subsidiary of Sorrento Therapeutics, Inc. (the "Company"), the Company, U.S. Bank National Association, as trustee (the "Trustee") and collateral agent (the "Agent"), and the beneficial owners of the senior secured notes due 2026 (the "Securities") and the holders of such Securities listed on the signature pages thereto (the "Holders") entered into an omnibus amendment (the "Amendment") to: (i) that certain Indenture, dated September 7, 2018, by and among Scilex, the Company, the Trustee and the Agent (the "Indenture"), and (ii) that certain Irrevocable Standby Letter of Credit issued by the Company to Scilex in the maximum aggregate amount of $35,000,000, with a date of issuance of September 7, 2018 (the "Letter of Credit") (Filing, 8-K, Sorrento Therapeutics, OCT 1, 2019, View Source [SID1234539981]).

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Pursuant to the Indenture, the Company agreed to irrevocably and unconditionally guarantee, on a senior unsecured basis, the punctual performance and payment when due of all obligations of Scilex under the Indenture. A portion of the proceeds from the offering of the Securities were used to fund a segregated reserve account pursuant to the terms of the Indenture. Pursuant to the Indenture, funds in the reserve account were to be released to Scilex upon receipt by the Trustee of an officer’s certificate under the Indenture from Scilex confirming receipt of a marketing approval letter from the United States Food and Drug Administration with respect to ZTlido (lidocaine topical system) 5.4% or a similar product with a concentration of not less than 5% on or prior to July 1, 2023.

Under the terms of the Amendment, among other things, the defined term "Change of Control" was revised to include, in addition to certain events described in the Indenture, (i) prior to the consummation of an initial public offering by Scilex Holding Company, the parent company of Scilex ("Scilex Holding") (the "Scilex Holding IPO"), the Company ceasing to own, directly or indirectly, a majority of the total voting and economic power of the issued and outstanding capital stock that is entitled to vote in the election of the Board of Directors (the "Voting Stock") of Scilex, (ii) at any time following the consummation of the Scilex Holding IPO, Scilex becoming aware of the acquisition by any person or group acquiring, in a single or in a related series of transactions, by way of merger, amalgamation, consolidation or other business combination or purchase of beneficial ownership of a majority of the total voting power of the issued and outstanding Voting Stock of Scilex or Scilex Holding, and (iii) Scilex Holding failing at any time to own 100% of the capital stock of Scilex. The Amendment also provides that Scilex will agree not to engage in or enter into any business other than the research, development, manufacture, sale, distribution, marketing, detailing, promotion, selling and securing of reimbursement of ZTlido (lidocaine topical system) 1.8% and any future iterations, improvements or modifications thereof (the "Product"), on a worldwide basis (exclusive of Japan), and activities that are necessary for, or otherwise relevant to, the same, subject to certain exceptions. The Amendment further provides that, if Scilex Holding fails to contribute $25.0 million of the proceeds of any Scilex Holding IPO to Scilex within three business days following the closing of the issuance and sale of Scilex Holding’s capital stock in the Scilex Holding IPO, such failure shall constitute an "Event of Default" under the Indenture.

In connection with the Amendment, Scilex agreed to repurchase, from each holder of Securities, Securities in a principal amount equal to (i) $20.0 million multiplied by (ii) a fraction the numerator of which will be the then outstanding principal amount of the Securities held by such holder and the denominator of which will be the then outstanding principal amount of all of the outstanding Securities, at a purchase price in cash equal to 100% of the principal amount thereof (such repurchase, the "Effective Date Repurchase"). Pursuant to the Amendment, the Holders agreed to release the funds in the reserve account for the purpose of consummating the Effective Date Repurchase and the remaining funds in the reserve account after the consummation of the Effective Date Repurchase will be released to Scilex by the Trustee and Agent.

The Amendment also modifies the Letter of Credit to provide that one of the conditions that will terminate the Letter of Credit will be the consummation of a Scilex Holding IPO that satisfies certain valuation thresholds.

The Amendment will be effective upon the satisfaction of certain terms and conditions, including the consummation of the Effective Date Repurchase. The Amendment will terminate if the Amendment does not become effective on or prior to October 1, 2020.

The Amendment includes representations and warranties of the parties, indemnification obligations and other terms and conditions customary in agreements of this type. The representations, warranties and covenants contained in the Amendment were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to the Amendment, and may be subject to limitations agreed upon by the contracting parties. Accordingly, the Amendment is incorporated herein by reference only to provide investors with information regarding the terms of the Amendment, and not to provide investors with any other factual information regarding the Company or its business, and should be read in conjunction with the disclosures in the Company’s periodic reports and other filings with the Securities and Exchange Commission.

The foregoing description of the Amendment does not purport to be complete and is qualified in its entirety by reference to the copy of the Amendment filed herewith as Exhibit 10.1. Certain terms of the Amendment have been omitted from this Current Report on Form 8-K and have been omitted from the version of the Amendment filed as Exhibit 10.1 to this Current Report on Form 8-K pursuant to Item 601(b)(10) of Regulation S-K because such terms are both (i) not material and (ii) would likely cause competitive harm to the Company if publicly disclosed.

NAVROGEN ENTERS INTO CRADA WITH THE U.S. NATIONAL CANCER INSTITUTE TO DEVELOP AGENTS TO OVERCOME TUMOR-MEDIATED IMMUNO-SUPPRESSION

On October 1, 2019 Navrogen, Inc. reported that it has entered into a Cooperative Research and Development Agreement (CRADA) with researchers at the U.S. National Cancer Institute (NCI) (Press release, Navrogen, OCT 1, 2019, View Source [SID1234539980]). The CRADA is focused on advancing antibody-based experimental medicines to targets associated with tumor-mediated immuno-suppression. Researchers at the NCI, led by Dr. Ira Pastan, NIH Distinguished Investigator and co-chief of NCI Center for Cancer Research’s Laboratory of Molecular Biology, have developed compounds that can uniquely target molecules on inflammatory cells and unlock their immuno-suppressed state within the tumor microenvironment. Under this CRADA, Navrogen is responsible for validating and advancing the preclinical development of these compounds towards clinical trials.

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"We have been fortunate to work with some of the leading researchers focused on immune-mediated anti-cancer therapies" stated Luigi Grasso, Ph.D., Chief Scientific Officer of Navrogen. The agents focused within this program have been previously shown in early clinical studies to unlock the immune response within tumors, and we hope to leverage their use with new approaches in tumors that exhibit immune suppression of this pathway."

The CRADA program complements Navrogen’s focus on developing novel agents that can overcome humoral immune suppression which is mediated by tumor-produced humoral immuno-oncology (HIO) factors.