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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Cellular Biomedicine Group to Present at the 2019 Cantor Global Healthcare Conference

On October 1, 2019 Cellular Biomedicine Group Inc. (NASDAQ: CBMG) ("CBMG" or the "Company"), a biopharmaceutical firm engaged in the drug development of immunotherapies for cancer and stem cell therapies for degenerative diseases, reported that Derrick Li, Head of Strategy for the Company, will present at Cantor Fitzgerald’s 2019 Global Healthcare Conference to be held at the InterContinental New York Barclay Hotel in New York, NY on Thursday, October 3, 2019 at 3:00pm ET (Press release, Cellular Biomedicine Group, OCT 1, 2019, View Source [SID1234539997]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

For more information about the conference, or to schedule a one-on-one meeting with CBMG management, please contact KCSA Strategic Communications at [email protected], your Cantor representative directly, or send an email to [email protected].

LineaRx’s iCTC Platform for Isolation of Circulating Tumor Cells Shows Superior Correlation over PSA as a Biomarker in Prostate Cancer Trial

On October 1, 2019 LineaRx, Inc., the majority-owned subsidiary of Applied DNA Sciences, Inc. (NASDAQ: APDN) focused on next-generation biotherapeutics, reported that its invasive Circulating Tumor Cells (iCTCs) platform demonstrated superior correlation over Prostate Specific Antigen (PSA) in an ongoing Phase II trial in recurrent prostate cancer (Press release, Applied DNA Sciences, OCT 1, 2019, View Source [SID1234539966]). Most notably, the concentration of rare iCTCs identified per milliliter of whole blood correlated more directly with disease status than did the levels of PSA. These iCTCs were captured and identified utilizing LineaRx’s technology platform recently acquired from Vitatex Inc.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

LineaRx’s collaborator Tyme Technologies, Inc. (NASDAQ: TYME), reported yesterday results of this recently completed Phase II trial using SM-88 to treat recurrent prostate cancer at the Congress of the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper), one of the preeminent meetings for highlighting new cancer therapies and diagnostics. The study updated the safety and antitumor effects of SM-88 in men with non-castrate non-metastatic prostate cancer. Antitumor effects were assessed by post-therapy changes in PSA and the number of iCTCs. Results showed that patients treated with this oral non-hormonal therapy maintained metastases-free survival without testosterone deprivation or typical hormonal therapy side effects.

Dr. Wen-Tien Chen, Principal Investigator of CTC Programs at LineaRx stated: "This use of iCTC quantification for providing earlier and more accurate identification of prostate cancer shows the importance of running trials using the iCTC functional capture and identification system from LineaRx. Published studies have shown that the concentration of iCTCs in blood correlates with disease status across other hard tumors, including metastatic sarcoma, pancreatic, ovarian, breast, lung and colorectal cancers. We believe our proprietary platform can help diagnose these difficult cancers earlier and with superior predictive capability."

The current reported SM-88 Phase II study examines iCTCs in prostate cancer for what we believe is the first time in a clinical trial. While PSA has historically been the recognized biomarker for prostate cancer, many studies over the last 20 years have shown it is an inadequate biomarker, since it may become elevated in patients with no apparent disease, or less serious pathology than cancer. Intensive efforts have been directed towards alternative prostate cancer biomarkers, particularly those that can predict disease aggressiveness and help to drive better treatment decisions. However, biomarker research has centered on disease diagnostics, rather than prognosis and prediction, which could work toward disease prevention—an important focus moving forward.

The authors concluded: "Reductions in iCTC number may be a more informative indicator of benefit than changes in PSA." Dr. Chen added, "New prostate cancer biomarkers should be targeted to addressing unmet clinical needs in prostate cancer management, including indicators for disease with low PSA values (<10ng/mL), prognostic markers to distinguish indolent from aggressive disease, and biomarkers for metastatic cancer."

LineaRx’s iCTC technology is unique in that it isolates iCTCs on a functional basis (the invasion of a model tissue for the extracellular matrix, or the tissue between cells in an organ) and allows the cells to be cultured for deeper genomic analysis. iCTCs are a model for metastasis, since the tumor cells have left the primary tumor and entered the circulation. The LineaRx platform may serve as a standalone device or as a front-end to increase the sensitivity of approved diagnostics.

"iCTCs have the potential for metastasis, and may be very useful in the diagnosis of cancer, even before tumors may be imaged," said Dr. James Hayward, CEO of LineaRx. "The present study is exciting because we believe it shows that iCTCs may be used to accurately follow therapy success in this very prevalent cancer while also providing new tools for cell and gene therapy design and production."

Boston Scientific Announces Conference Call Discussing Third Quarter 2019 Financial Results

On October 1, 2019 Boston Scientific Corporation (NYSE: BSX) reported that it will webcast its conference call discussing financial results and business highlights for the third quarter ended September 30, 2019 on Wednesday, October 23, 2019 at 8:00 a.m. EDT (Press release, Boston Scientific, OCT 1, 2019, View Source [SID1234539998]). The call will be hosted by Mike Mahoney, chairman and chief executive officer, and Dan Brennan, executive vice president and chief financial officer. The company will issue a news release announcing financial results for the third quarter on Wednesday, October 23, 2019, prior to the conference call.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of the conference call will be available on the Investor Relations section of the website at investors.bostonscientific.com.

A replay of the webcast will be archived and available at investors.bostonscientific.com beginning approximately one hour following the completion of the meeting.

Avidity Biosciences Appoints Sarah Boyce as Chief Executive Officer

On October 1, 2019 Avidity Biosciences, a privately-held biotechnology company pioneering Antibody Oligonucleotide Conjugates (AOCs), reported the appointment of global business leader Sarah Boyce as President and Chief Executive Officer and a member of the Avidity Board of Directors (Press release, Avidity Biosciences, OCT 1, 2019, View Source [SID1234539967]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are delighted to welcome Sarah as the new CEO of Avidity Biosciences," said Troy Wilson, Ph.D., J.D., Executive Chairman of the Board of Directors, co-founder and founding CEO of Avidity. "Sarah’s broad experience in the healthcare industry, combined with her strategic expertise and track record of leading high-performance teams, position her to be a great partner to both the board and management as we continue to advance our pipeline, optimize our AOC platform and prepare to initiate our first clinical study."

Ms. Boyce brings to Avidity extensive experience in the life sciences industry, where she has built global organizations and brought to patients a number of innovative therapies, including Tegsedi, Waylivra, Soliris, Gleevec and Tasigna. She most recently served as President and a member of the board of directors of Akcea Therapeutics, where she led commercialization of the company’s rare disease products. Prior to joining Akcea in April 2018, Ms. Boyce held multiple executive-level roles at leading pharma and biotech companies including Ionis Pharmaceuticals, Forest Laboratories, Alexion Pharmaceuticals, Novartis Oncology and Roche.

"I am honored by the opportunity the board has extended and am excited to lead Avidity through its next phase of growth," said Sarah Boyce, President and CEO of Avidity Biosciences. "I look forward to working with the leadership team and the board to continue to expand the proprietary AOC technology which combines the benefits of two innovative therapeutic approaches into a pioneering platform and to usher the first wave of potential therapeutics into the clinic."