On April 16, 2020, Aeglea BioTherapeutics, Inc. (the "Company") reported that entered into a Capital on DemandTM Sales Agreement (the "Offering Agreement") with JonesTrading Institutional Services LLC, as agent ("JonesTrading"), pursuant to which the Company may offer and sell, from time to time through JonesTrading shares of the Company’s common stock, par value $0.0001 per share (the "Common Stock"), having an aggregate offering price of up to $60.0 million (the "Shares") (Filing, 8-K, Aeglea BioTherapeutics, APR 16, 2020, View Source [SID1234556381]).

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The offer and sale of the Shares will be made pursuant to a shelf registration statement on Form S-3 (File No. 333-228967) and the related base prospectus filed by the Company with the Securities and Exchange Commission (the "SEC") on December 21, 2018 as subsequently amended, and declared effective by the SEC on February 13, 2019, as supplemented by a prospectus supplement (the "Prospectus Supplement") dated April 16, 2020 and filed with the SEC pursuant to Rule 424(b) under the Securities Act of 1933, as amended (the "Securities Act").

Pursuant to the Offering Agreement, JonesTrading may sell the Shares by any method permitted by law deemed to be an "at the market offering" as defined in Rule 415 of the Securities Act (the "Offering"). JonesTrading will use commercially reasonable efforts consistent with its normal trading and sales practices to sell the Shares from time to time, based upon instructions from the Company, including any price or size limits or other customary parameters or conditions the Company may impose.

The Company is not obligated to make any sales of the Shares under the Offering Agreement. The offering of Shares pursuant to the Offering Agreement will terminate upon the earliest of (a) the sale of all the Shares subject to the Offering Agreement or (b) the termination of the Offering Agreement by JonesTrading or the Company, as permitted therein.

The Company will pay JonesTrading a commission rate up to 3.0% of the aggregate gross proceeds from each sale of Shares and have agreed to provide JonesTrading with customary indemnification and contribution rights. The Company will also reimburse JonesTrading for certain specified expenses in connection with entering into the Offering Agreement. The Offering Agreement contains customary representations and warranties and conditions to the placements of the Shares pursuant thereto.

The foregoing description of the Offering Agreement is not complete and is qualified in its entirety by reference to the full text of such agreement, a copy of which is filed herewith as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference. The opinion of the Company’s counsel regarding the validity of the Shares that will be issued pursuant to the Offering Agreement is also filed herewith as Exhibit 5.1.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the Common Stock discussed herein, nor shall there be any offer, solicitation, or sale of common stock in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

On April 16, 2020 Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, reported that it will report first quarter 2020 earnings results for the period ended March 27, 2020 on Tuesday, May 5, 2020 (Press release, Mallinckrodt, APR 16, 2020, View Source [SID1234556397]).

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A conference call for investors will begin at 8:30 a.m. Eastern Time. The call can be accessed in three ways:

At the Mallinckrodt website: http://mallinckrodt.com/investors/events-calendar/.
By telephone: For both listen-only participants and those who wish to take part in the question-and-answer portion of the call, the telephone dial-in number in the U.S. is (877) 359-9508. For participants outside the U.S., the dial-in number is (224) 357-2393. Callers will need to provide the Conference ID of 1572379.
Through an audio replay: A replay of the call will be available beginning at 11:30 a.m. Eastern Time on Tuesday, May 5, 2020, and ending at 11:59 p.m. Eastern Time on Tuesday, May 19, 2020. Dial-in numbers for U.S.-based participants are (855) 859-2056 or (800) 585-8367. Participants outside the U.S. should use the replay dial-in number of (404) 537-3406. All callers will be required to provide the Conference ID of 1572379.

On April 16, 2020 Foundation Medicine, Inc. reported that the U.S. Food and Drug Administration (FDA) approved FoundationOneCDx as the registrational companion diagnostic for Incyte’s Pemazyre (pemigatinib), a selective fibroblast growth factor receptor (FGFR) inhibitor approved for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test (Press release, Foundation Medicine, APR 16, 2020, View Source [SID1234556420]). FoundationOne CDx is the first and only FDA-approved companion diagnostic test for this indication.

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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

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Cholangiocarcinoma is a rare cancer, diagnosed in approximately 8,000 patients annually, according to the American Cancer Society. It is classified based on its origin: intrahepatic cholangiocarcinoma (iCCA) occurs in the bile duct inside the liver and extrahepatic cholangiocarcinoma occurs in the bile duct outside the liver. FGFR2 fusions or select rearrangements occur in 10-16 percent of iCCA patients.1, 2, 3 Because this cancer is difficult to detect, patients with cholangiocarcinoma are often diagnosed at a late or advanced stage when the prognosis is poor and treatment options are limited.4 The approval of this novel therapy and companion diagnostic means healthcare professionals will be able to use Foundation Medicine’s comprehensive genomic profiling (CGP) assay, FoundationOne CDx, to identify patients with FGFR2 fusions and select rearrangements who may benefit from treatment with Pemazyre in accordance with the approved therapeutic product labeling.

"The approval of this therapy and companion diagnostic is an important step forward in advancing care for patients with cholangiocarcinoma for whom there are limited treatment options," said Brian Alexander, M.D., M.P.H., chief medical officer at Foundation Medicine. "The breadth and depth of our sequencing allows for identification of patients with this rare fusion who may benefit from Pemazyre, underscoring the importance of comprehensive genomic profiling in cholangiocarcinoma. We continue to work toward broadening patient access to biomarker-driven therapies, illustrated by this recent milestone. We are proud to add another important FDA-approved companion diagnostic to FoundationOne CDx."

FoundationOne CDx is the first FDA-approved broad companion diagnostic that is clinically and analytically validated for solid tumors. It is currently approved as the companion diagnostic test for 20 unique therapies across multiple cancer types.

"Patients with rare cancers like cholangiocarcinoma often face additional challenges when it comes to available research and treatment options for their condition," said Jim Palma, Executive Director at Target Cancer Foundation. "The approval of this therapy and companion diagnostic is a turning point for these patients and the rare cancer community as a whole. Not only could it be lifechanging for cholangiocarcinoma patients with FGFR2 fusions and select rearrangements, but it reinforces the critical need for comprehensive genomic profiling and the power of collaboration among scientists, clinicians, patients and advocacy organizations."

Incyte announced earlier today the U.S. FDA approval of Pemazyre as the first selective FGFR inhibitor for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement as detected by an FDA-approved test. Pemazyre is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations. More information about Pemazyre can be found at www.pemazyre.com.

About FoundationOne CDx

FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens. FoundationOne CDx is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit View Source

About FGFR

Fibroblast growth factor receptors (FGFRs) play an important role in tumor cell proliferation and survival, migration and angiogenesis (the formation of new blood vessels). Activating fusions, rearrangements, translocations and gene amplifications in FGFRs are closely correlated with the development of various cancers.

On April 16, 2020 LegoChem Biosciences, Inc. ("LCB") (KOSDAQ:141080), based in Daejeon, South Korea, reported that it has entered a research collaboration and license agreement with Iksuda Therapeutics ("Iksuda") for the development of antibody-drug conjugates in oncology (Press release, LegoChem Biosciences, APR 16, 2020, View Source [SID1234556382]).

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Iksuda gains certain rights to LCB’s antibody-drug conjugate (ADC) technology, ConjuALL, including LCB’s cancer-selectively activated payloads as well as its proprietary linker and conjugation platform, to research, develop and commercialize targeted anti-cancer therapeutics. Under the terms of the agreement, Iksuda has the rights to use the LCB technology to develop therapeutics directed to up to three undisclosed targets.

LCB will receive development, regulatory and commercial milestone payments of up to $407.25 million as well as royalties on the sales of any resulting ADC products. In addition, LCB is eligible to receive a prearranged percentage of sublicense revenue if Iksuda enters into a license agreement with third party companies.

Iksuda, a UK-based biotech company established in 2012, is focusing on the development of novel ADC therapeutics. Iksuda has built up a world-class R&D team including Dr. Robert Lutz, CSO of Iksuda, who is a global ADC expert and has significantly contributed to the successful development and commercialization of a blockbuster drug, Kadcyla as well as several other ADC therapeutics when he was at Immunogen.

"We plan to advance ADC products from this partnership to clinical stage as quickly as possible," said Dr. David Simpson, the CEO of Iksuda. "This collaboration will allow us to leverage LCB’s next-generation linker and payload platform and combining it with our expertise and capabilities in ADC development will enable success."

"We are pleased to collaborate with Iksuda given its experience and expertise in ADC research and development. This agreement highlights that not only is LCB delivering unique, differentiated linker technology, but great potential and wide applicability of our proprietary payload, is also now endorsed by global experts from Iksuda," said Dr. Yong-Zu Kim, the CEO & President of LCB. "Our goal is to demonstrate the competitiveness of LegoChem Bio in human trials in a most efficient way by applying our ADC platform to Iksuda’s pipelines."

On April 16, 2020 4SC AG (4SC, FSE Prime Standard: VSC) reported that it will publish its Q1 report 2020 on 21 April 2020 (Press release, 4SC, APR 16, 2020, View Source [SID1234556398]). On this day, the Management of 4SC AG will host a conference call at 3 pm CEDT (9 am EDT) to inform about important developments in the reporting period and beyond.

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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

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Investors, financial analysts, and journalists interested in participating in the conference call can access via the telephone numbers stated below. Please join the event conference 5-10 minutes prior to the start time. You will be asked to provide the confirmation code.

Date: 21 April 2020
Time: 3 pm CEDT (9 am EDT)
Phone Numbers: +49 (0)32 22109 8334 (Germany)
+44 (0)20 3936 2999 (United Kingdom)
+1 646 664 1960 (USA)
Confirmation Code: 754006
A presentation document supporting the conference call will be available on 21 April 2020, at 4SC’s website. After the event, a replay can be accessed from there as well.