On January 7, 2020 Replimune Group Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported that Robert Coffin, Ph.D., Chief Executive Officer and Director of Replimune, will present at the 38th Annual J.P. Morgan Healthcare Conference on Tuesday, January 14, 2020 at 5:00 PM PT at the Westin St. Francis Hotel in San Francisco, CA (Press release, Replimune, JAN 7, 2020, View Source [SID1234552972]).

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A simultaneous webcast will be available in the Investors section of Replimune’s website at www.replimune.com. A replay will be available for 30 days following the conference.

On January 7, 2020 Cellect Biotechnology Ltd. (Nasdaq: APOP), a developer of innovative technology which enables the functional selection of stem cells, reported it received official communication from two jurisdictions, the European Patent Office (EPO) and the Israeli Intellectual Property Office, regarding their intention to grant European Patent Application No. 14851547.1 and Israeli Patent Application No. 244982, respectively (Press release, Cellect Biotechnology, JAN 7, 2020, View Source [SID1234552828]). These patent applications include a cell-based product and a method of manufacturing a stem and progenitor cell population with enhanced activity by short incubation with an apoptotic ligand.

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"Continued recognition from global jurisdictions validates the breadth of Cellect’s technology. These latest acknowledgments are significant as they cover the ability to activate stem cells, therefore improving stem cell products and manufacturing processes," commented Dr. Shai Yarkoni, Chief Executive Officer of Cellect. "Our collaboration efforts with companies in Germany, Korea and Israel have each reported similar data using our process in various tissue sources (including fat derived cells). These added protections continue to create barriers to entry and allows us to advance our business development strategies to monetize our innovation."

The Company has previously published third-party data demonstrating improved "stemness" of stem cells. Specifically, it significantly improves both proliferation and functional capabilities of hematopoietic (HSC) and mesenchymal (MSC) stem cells originating from bone marrow, peripheral blood, umbilical cord and adipose tissue.

"We believe the combination of strong IP protection and validated business collaborations support our business model and will enable us to attract external resources to strengthen and expand our opportunities," concluded Dr. Yarkoni.

The patents applications cover an ex vivo method for obtaining an improved population of stem and progenitor cells (SPC) with enhanced engraftment characteristics by activation of TNF family receptors. The Company’s previous patents covered the negative selection exerted by the ApoGraft process and product translated into clinical safety superiority. The latest patent applications describe and protect the positive effect that the same molecules have on stem cells and translates to the efficacy of the transplanted cells and the yields of the manufacturing processes for clinical use).

Including this latest notification, the Company has 65 patent applications worldwide of which 33 are issued/allowed patents.

On January 7, 2020 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium") reported that Sandesh Seth, Actinium’s Chairman and CEO, will present at the 2020 Biotech Showcase being held on January 13-15 (Press release, Actinium Pharmaceuticals, JAN 7, 2020, View Source [SID1234552827]). The conference will be at the Hilton San Francisco Union Square. Details of Actinium’s presentation are as follows:

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Date: Monday, January 13, 2020
Time: 2:30 pm PT
Track: Yosemite C (Ballroom Level)
Venue: Hilton San Francisco Union Square

Members of Actinium’s Executive and Corporate Development teams will be available for 1-on-1 meetings during the conference. Those interested in scheduling a meeting with Actinium may do so by contacting David Gould, MD, Actinium’s SVP, Corporate Development & Corporate Affairs via email at [email protected].

About Biotech Showcase

Biotech Showcase, produced by Demy-Colton and EBD Group, is an investor and networking conference devoted to providing private and public biotechnology and life sciences company with an opportunity to present to, and meet with, investors and executives in one place during the course of one of the industry’s largest annual healthcare investor conferences, J.P. Morgan Annual Healthcare Conference.

On January 7, 2020 Nuvo Pharmaceuticals Inc. (Nuvo or the Company) (TSX:NRI;OTCQX:NRIFF), a Canadian focused healthcare company with global reach and a diversified portfolio of commercial products, reported the Company will repay its Bridge Loan to Deerfield Management Company, L.P. (Deerfield) during the second week of January and will receive the full US$7.5 million annual minimum royalty payment due from the 2019 sales of Vimovo in the U.S (Press release, Nuvo Pharmaceuticals, JAN 7, 2020, View Source [SID1234552826]). The Company has received US$5.6 million to-date.

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Bridge Loan to Deerfield

The US$6.0 million Bridge Loan was one component of the financing provided by Deerfield in support of the acquisition of Aralez Pharmaceuticals Canada, the U.S. and International rights to Vimovo and other related assets as announced on December 31, 2018. The Company will repay its Bridge Loan (12.5% per annum) during the second week of January, ahead of its June 2020 maturity date. The Company’s remaining loans, US$52.5 million and US$60.0 million carry coupon interest rates of 3.5% per annum.

In June 2019, the Company announced its intention to reduce annual operating expenses by approximately $7.0 million due to identified synergies and the implementation of organizational changes. The Company began to realize these synergies during the second half of 2019.

In June 2019, Deerfield and certain of its affiliated funds, as lenders, and the Company agreed to an amendment to its financing agreement to provide, among other things, for a payment deferral mechanism in the event that Vimovo U.S. market exclusivity is lost. The amendment will allow Nuvo the option to defer a portion of the mandatory minimum quarterly prepayments by the difference between one quarter of the existing US$7.5 million annual minimum royalty due from Vimovo sales in the U.S. and the actual amount of royalties received in the applicable quarter in the event Vimovo U.S. market exclusivity is lost earlier than May 2022. The amount of any deferred prepayment would, until repaid in accordance with the amendment, be subject to an interest rate of 12.5% per annum.

Vimovo U.S. Royalty

As of December 31, 2019, no generic version of Vimovo had been launched in the U.S. during 2019 and, as of the end of business on January 6, 2020, the U.S. Food and Drug Administration (FDA) had not granted final approval for a generic version of Vimovo. As a result, the Company is entitled to the US$7.5 million annual minimum royalty due from the 2019 sales of Vimovo in the U.S., as per the agreement with its U.S. commercial partner.

The Company had previously disclosed its assumption that a generic version of Vimovo would be launched in the U.S. during the second half of 2019. The Company anticipates a generic version of Vimovo will launch in the U.S. during 2020. Upon launch of a generic version of Vimovo in the U.S., Nuvo Pharmaceuticals (Ireland) DAC’s (Nuvo Ireland) US$7.5 million annual minimum royalty from its partner ceases. The royalty rate for 2020 would be calculated as 10% of net sales of Vimovo in the U.S., subject to certain step-down provisions upon achievement of generic market share thresholds. A launch of a generic version of Vimovo in the U.S. does not impact Nuvo Ireland’s global Vimovo business in markets outside of the U.S. Nuvo Ireland will continue to receive royalty payments from its global partner, Grunenthal GmbH on global net sales of Vimovo.

Any launch of a generic version of Vimovo in the U.S. is considered "at risk" as Nuvo Ireland continues to hold U.S. Patent Nos. 8,858,996 and 9,161,920 (the ‘996 and ‘920 patents) covering Vimovo in the U.S. The ‘996 and ‘920 patents are currently the subject of patent infringement litigation against Dr. Reddy’s Laboratories Inc. The parties have mutually agreed on a pretrial litigation schedule with the U.S. District Court of New Jersey through to mid-2021. The term of the ‘996 and ‘920 patents extends to May 31, 2022. Nuvo Ireland, with its commercial partner, continue to work together to vigorously defend these patents.

On January 7, 2020 Revolution Medicines, Inc., a clinical-stage oncology company focused on developing targeted therapies to inhibit elusive frontier targets within notorious cancer pathways, reported that preliminary data from the company’s Phase 1 clinical trial (RMC-4630-01) of RMC-4630 will be presented at the 6th AACR (Free AACR Whitepaper)-IASLC International Joint Conference: Lung Cancer Translational Science from the Bench to the Clinic being held January 11-14, 2020 in San Diego, CA (Press release, Revolution Medicines, JAN 7, 2020, https://www.prnewswire.com/news-releases/revolution-medicines-to-present-preliminary-data-from-phase-1-clinical-trial-of-rmc-4630-at-6th-aacr-iaslc-international-joint-conference-300982012.html [SID1234552825]).

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RMC-4630, the company’s investigational SHP2 inhibitor, is a potent and orally bioavailable small molecule that is designed to selectively inhibit the activity of SHP2, an upstream cellular protein that plays a key role in modulating cell growth by transmitting signals from receptor tyrosine kinases to RAS. The ongoing Phase 1 monotherapy study is evaluating RMC-4630 for a range of tumor types featuring specific, molecularly-defined oncogenic mutations.

Data from the study will be reported in podium and poster presentations entitled, "The SHP2 inhibitor RMC-4630 in patients with KRAS-mutant non-small cell lung cancer: Preliminary evaluation of a first-in-man phase 1 clinical trial."

Details of the presentations are as follows:

Podium Presentation:

Session: Plenary Session 1: Therapeutic Targeting and Vulnerabilities of Ras-Driven Lung Cancer
Presenting Author: Sai-Hong Ignatius Ou, M.D., Ph.D., Chao Family Comprehensive Cancer Center, University of California, Irvine
Session Date/Time: Saturday, January 11, 2020, 4:30 – 6:15 p.m. Pacific
Poster Presentation:

Poster Number: A12
Session: Poster Session A
Presenting Author: Sai-Hong Ignatius Ou, M.D., Ph.D., Chao Family Comprehensive Cancer Center, University of California, Irvine
Session Date/Time: Sunday, January 12, 2020, 12:00 – 2:00 p.m. Pacific
In addition to the presentations on RMC-4630, Revolution Medicines will also report preclinical data on its mutant RAS(ON) inhibitors in a poster presentation at the conference. Details of that presentation are as follows:

Poster Presentation:

Poster Number: A06
Title: Tri-complex inhibitors of the oncogenic, GTP-bound form of KRASG12C overcome RTK-mediated escape mechanisms and drive tumor regressions in preclinical models of NSCLC
Session: Poster Session A
Presenting Author: Robert Nichols, Ph.D., associate director, systems biology at Revolution Medicines
Session Date/Time: Sunday, January 12, 2020, 12:00 – 2:00 p.m. Pacific
About RMC-4630 and Sanofi Collaboration

The RMC-4630 program is the focus of an exclusive global research, development and commercialization agreement with Sanofi, under which Revolution Medicines received a $50 million upfront payment, and Sanofi agreed to reimburse Revolution Medicines for substantially all research and all development costs for the joint SHP2 program. Sanofi received an exclusive worldwide license for global commercialization of any approved products targeting SHP2, subject to a U.S. co-promote right for Revolution Medicines. The companies have agreed to enter into a 50/50 profit and loss share arrangement in the U.S., and Revolution Medicines is entitled to receive tiered royalties on annual net sales ranging from high single digit to mid-teen percentages on sales in other markets. Revolution Medicines could also receive more than $500 million in development and regulatory milestone payments.