On June 18, 2020 CryoLife, Inc. (NYSE: CRY) ("CryoLife" or "the Company"), a leading cardiac and vascular surgery company focused on aortic disease, reported that it intends to offer, subject to market conditions and other factors, $100,000,000 aggregate principal amount of convertible senior notes due 2025 (the "Notes") in a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, CryoLife, JUN 18, 2020, View Source [SID1234561238]). CryoLife also intends to grant the initial purchasers of the Notes an option to purchase, within a 13-day period beginning on, and including, the date on which the Notes are first issued, up to an additional $15,000,000 aggregate principal amount of the Notes.

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!

The Notes will be senior unsecured obligations of the Company. The Notes are expected to pay interest semiannually and will mature on July 1, 2025, unless earlier converted, redeemed or repurchased in accordance with their terms. Conversion of the Notes will be settled in cash, shares of the Company’s common stock, or a combination thereof, at the Company’s election. The final terms of the Notes, including the interest rate, initial conversion rate, and other terms, will be determined by negotiations between the Company and the initial purchasers of the Notes.

The Company expects to use the net proceeds from the offering for general corporate purposes, including the repayment of approximately $30 million outstanding under its revolving credit facility. If the initial purchasers exercise their option to purchase additional Notes, the Company expects to use the net proceeds from the sale of the additional Notes for general corporate purposes.

This press release does not and shall not constitute an offer to sell nor a solicitation of an offer to buy the Notes or shares of the Company’s common stock, nor shall there be any offer, solicitation or sale of the Notes or such common stock in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. The offering may be made only by means of an offering memorandum.

The Notes and any shares of the Company’s common stock issuable upon conversion of the Notes have not been, and will not be, registered under the Securities Act, or the securities laws of any other jurisdiction, and may not be offered or sold in the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and the rules promulgated thereunder and applicable state securities laws. The offering of the Notes is being made only to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act.

On June 18, 2020 Linnaeus Therapeutics, Inc. (Linnaeus), a privately held clinical-stage biopharmaceutical company focused on the development and commercialization of novel small-molecule oncology therapeutics, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for LNS8801 for the treatment of patients with metastatic or unresectable melanoma who have progressed on or after anti–programmed cell death receptor or ligand (anti–PD-1/L1) therapy (Press release, Linnaeus Therapeutics, JUN 18, 2020, View Source [SID1234561237]).

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!

Linnaeus is currently evaluating LNS8801 in a phase 1 clinical trial in patients with advanced cancer. The company expects to identify the recommended phase 2 dose this summer and to begin its phase 2 program evaluating LNS8801 as a monotherapy and in combination with targeted therapies in early fall.

LNS8801 is a first-in-class, orally bioavailable, small-molecule that is a highly specific and potent agonist of the G-protein estrogen receptor (GPER). GPER is widely expressed on cancers. Agonizing GPER both stops cancers from proliferating and makes them more visible to the immune system.

"Receiving Fast Track designation for LNS8801 is an important step in its clinical development as we near the end of our phase 1 dose-escalation study and advance LNS8801 into phase 2 clinical trials," said Patrick Mooney, MD, Chief Executive Officer of Linnaeus. "We are pleased that the FDA recognizes the potential of LNS8801 to help patients with melanoma who have progressed after anti–PD-1/L1 therapy."

About Fast Track Designation
Fast Track designation is a process designed to facilitate the expedited development and review of new drugs that treat serious or life-threatening conditions and that have demonstrated the potential to fill an unmet medical need. The purpose is to advance new drugs earlier for patients who need them.

A company with a drug that receives Fast Track designation is eligible for some or all of the following:

More frequent meetings with the FDA to discuss the drug’s development and ensure collection of the appropriate data needed to support drug approval
More frequent written communication from the FDA about such things as the design of the proposed clinical trials and use of biomarkers
Eligibility for Accelerated Approval and Priority Review if relevant criteria are met
Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by the FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA.
About LNS8801
LNS8801 is an orally bioavailable and highly specific agonist of GPER whose activity is dependent on the expression of GPER. GPER activation suppresses well-known tumor-associated genes, such as c-Myc and PD-L1. In preclinical cancer models, LNS8801 displays potent antitumor activities across a wide range of tumor types, rapidly shrinking tumors and inducing immune memory. LNS8801 monotherapy has shown significant antitumor activity, including inducing complete responses that are immune to rechallenge. LNS8801 also has shown effects when combined with targeted therapies, chemotherapies, and immunotherapies. LNS8801 is currently in a phase 1/2 clinical trial in patients with advanced cancer at six comprehensive cancer centers in the United States.

On June 18, 2020 Almac Discovery reported that it will present significant new data on their lead Oncology programmes – the next generation protein drug conjugate programme targeting ROR1 and its lead small molecule inhibitor programme targeting USP7 in poster sessions at this year’s American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II, which is being held June 22-24, 2020 (Press release, Almac, JUN 18, 2020, View Source [SID1234561236]). Both programmes are advancing towards the nomination of candidate drugs, and the new data highlight significant progress that has been made in the last year towards this goal.

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 have developed ADP-c165, a potent and selective ROR1-targeting protein drug conjugate that exploits the properties of small VNAR protein domains. This agent shows excellent efficacy in patient-derived xenograft models with complete and durable regressions observed. We are excited to share this data at the 2020 AACR (Free AACR Whitepaper) Virtual Annual Meeting and the potential of this novel PDC for the treatment of solid tumour indications, particularly triple-negative breast cancer," commented Graham Cotton, Head of Protein Therapeutics, Almac Discovery.

Xavier Jacq, VP Biology at Almac Discovery, said, "Using our potent and highly selective USP7 inhibitors, we have uncovered a completely novel mode of action for USP7 in modulating and reprograming the tumour microenvironment by directly impacting VEGF secretion from fibroblasts. In addition to the established modulation of the p53/MDM2 pathway in cancer cells, this important finding supports new opportunities for combining USP7 inhibitors with immune modulators. We are delighted to share our recent discovery differentiating USP7 inhibition from MDM2 antagonists at the upcoming AACR (Free AACR Whitepaper) Virtual Annual Meeting."

Details are as follows:

Title: Discovery of a novel function for USP7 inhibitors: Reprogramming the tumour microenvironment
Authors: Anamarija Jurisic, Julien Daubriac, Mark Wappett, Ian T. Lobb, Aaron Cranston, Stephanie Burton, Peggy Sung, Gerald Gavory, Colin R. O’Dowd, Tim Harrison, Xavier Jacq. Almac Discovery, Belfast, UK
Abstract Number: 8303
Session: Drug Targets in the Microenvironment
Poster Number: #6057
Type: E-poster
Date & Time: 22 June (9:00 a.m. – 6:00 p.m. EDT)

Title: Exploiting the properties of VNAR domains for the development of novel efficacious protein drug conjugates targeting the oncofetal protein ROR1
Authors: Graham Cotton, Jennifer Thom, Paul Trumper, Andrei Kamenski, Stacey Bell, Mark Wappett, Caroline Barelle, Marina Kovaleva, Alicia Campion, Elisa Persiani, Andrew Porter, Estelle McLean, Aidan McCann, Chiara Saladino, Aaron Cranston, Tim Harrison. Almac Discovery, Edinburgh, United Kingdom, Elasmogen Ltd, Aberdeen, United Kingdom, Almac Discovery, Belfast, UK
Abstract Number:2785
Session: Antibody Technologies
Poster Number: 538
Type: E-poster
Date & Time: 22 June (9:00 a.m. – 6:00 p.m. EDT)

On June 18, 2020 Amgen (NASDAQ: AMGN) reported that it will present at the BMO Capital Markets 2020 Prescriptions for Success Healthcare Conference at 4:00 p.m. ET on Tuesday, June 23, 2020 (Press release, Amgen, JUN 18, 2020, View Source [SID1234561235]). Elliott Levy, senior vice president of R&D Strategy and Operations at Amgen, will present at the conference. Live audio of the presentation can be accessed from the Events Calendar on Amgen’s website, www.amgen.com, under Investors. A replay of the webcast will also be available on Amgen’s website for 90 days following the event.

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!

On June 18, 2020 Personalis, Inc., (Nasdaq: PSNL) a leader in advanced genomics for cancer, reported the company’s participation in the European Association for Cancer Research (EACR) 2020 Virtual Congress, which will be held online, June 18-19, 2020 (Press release, Personalis, JUN 18, 2020, View Source [SID1234561234]).

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!

Personalis will present "Enabling Composite Biomarker Discovery for Precision Cancer Therapy with an Enhanced Exome and Transcriptome Platform" in an industry-sponsored symposium, featuring the Personalis universal cancer immunogenomics platform, ImmunoID NeXT. Erin Newburn, MS, PhD, will present for Personalis.

Dr. Newburn will provide an overview of how the platform can be used to explore critical immunotherapy-related resistance mechanisms and novel composite biomarkers of response utilizing analytics including human leukocyte antigen (HLA) typing and HLA loss of heterozygosity (LOH), neoantigen prediction and load, immune repertoire characterization, and oncoviral detection, as well as the evaluation of tumor mutational burden (TMB) and microsatellite instability (MSI) status. In addition, Dr. Newburn will present a recent case study from a cohort of metastatic melanoma patients who were treated with an immune checkpoint blockade, where we integrated several different molecular features from the ImmunoID NeXT Platform to help better define the responder and non-responder patients.