Equillium Announces Pricing of $30 Million Registered Direct Offering

On February 4, 2021 Equillium, Inc. (Nasdaq: EQ) a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders, reported that it has entered into a securities purchase agreement with life science institutional investment funds managed by Decheng Capital, to purchase 4,285,710 units (the "Units") from Equillium, with each Unit consisting of one share of common stock and a warrant to purchase 0.3 of a share of common stock. The purchase price per Unit is $7.00, priced above the market under Nasdaq rules (Press release, Equillium, FEB 4, 2021, View Source [SID1234574610]). The warrants will have an exercise price of $14.00 per share, will be immediately exercisable, and will expire on the earlier of (i) the fifth anniversary of issuance, or (ii) the 15th calendar date following the date on which Equillium closes a financing raising a minimum of $25 million at a price per share of no less than $25.00.

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The gross proceeds from the registered direct offering are expected to be $30.0 million before deducting offering expenses. The Company intends to use the net proceeds to primarily fund the continued development of the itolizumab pipeline, potential acquisitions and development of new products, and for working capital and general corporate purposes. The registered direct offering is expected to close on or about February 5, 2021, subject to the satisfaction of customary closing conditions.

The securities described above are being offered pursuant to a "shelf" registration statement (File No. 333-234683) filed with the Securities and Exchange Commission (the "SEC") on November 13, 2019 and declared effective on November 25, 2019. Such securities may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A prospectus supplement and the accompanying prospectus relating to the offering of the securities will be filed with the SEC. Electronic copies of the prospectus supplement and the accompanying prospectus relating to the offering of the securities may be obtained, when available, on the SEC’s website at View Source

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor there any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

Ultragenyx to Host Conference Call for Fourth Quarter and Full-Year 2020 Financial Results and Corporate Update

On February 4, 2021 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for serious rare and ultra-rare genetic diseases, reported that it will host a conference call on Thursday, February 11, 2021 at 5pm ET to discuss its financial results and corporate update for the fourth quarter and the year ended December 31, 2020 (Press release, Ultragenyx Pharmaceutical, FEB 4, 2021, https://ir.ultragenyx.com/news-releases/news-release-details/ultragenyx-host-conference-call-fourth-quarter-and-full-year-5 [SID1234574628]).

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The live and replayed webcast of the call will be available through the company’s website at View Source To participate in the live call by phone, dial (855) 797-6910 (USA) or (262) 912-6260 (International) and enter the passcode 6391931. The replay of the call will be available for one year.

Mirati Therapeutics To Present At Guggenheim Healthcare Talks 2021 Oncology Days

On February 4, 2021 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical stage targeted oncology company, reported they will participate in a fireside chat at the Guggenheim Healthcare Talks 2021 Oncology Days on Thursday, February 11th at 9:00 a.m. ET/6:00 a.m. PT. Dan Faga, Executive Vice President and Chief Operating Officer, will represent Mirati at the event (Press release, Mirati, FEB 4, 2021, View Source [SID1234574645]).

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The webcast will be available through the "Investors" section of the Mirati website at View Source, and a replay of the webcast will be made available for 90 days following the event.

Theratechnologies’ Lead Peptide Drug Conjugate TH1902 Receives FDA Fast Track Designation For The Treatment Of Sortilin-Expressing Cancers

On February 4, 2021 Theratechnologies Inc. (Theratechnologies) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported that the United States Food and Drug Administration (FDA) has granted fast track designation to TH1902 as a single agent for the treatment of patients with sortilin positive recurrent advanced solid tumors that are refractory to standard therapy (Press release, Theratechnologies, FEB 4, 2021, View Source [SID1234574991]).

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"Receiving fast track designation for TH1902 at this early stage of development is a significant recognition for our SORT1+ Technology and further supports the future development of TH1902. The designation, which applies to all solid tumours expressing sortilin, also highlights the broad applicability and immense medical need for innovative, targeted, and potentially more effective and better-tolerated therapies for cancer," said Dr. Christian Marsolais, Senior Vice President and Chief Medical Officer, Theratechnologies.

Onxeo Enters Clinical Research Agreement with Institut Curie to Conduct a phase 1b/2 Clinical Trial of AsiDNA™ in combination with radiotherapy for Treatment of High-Grade Glioma Relapse in Children

On February 4, 2021 Onxeo S.A. (Euronext Growth: ALONX, Nasdaq First North: ONXEO), ("Onxeo" or "the Company"), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage Response (DDR), in particular against rare or resistant cancers, reported that the Company has entered into a clinical research agreement with Institut Curie, the French leading cancer center, to conduct a phase 1b/2 study designed to evaluate the effect of AsiDNA, Onxeo’s first-in-class DDR inhibitor, in combination with radiotherapy in children with High-Grade Glioma (HGG) relapse and eligible to re-irradiation (Press release, Onxeo, FEB 4, 2021, View Source [SID1234575014]).

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High Grade Gliomas, representing about 20% of all pediatric central nervous system (CNS) tumors, still have a dismal outcome with a 5-year survival of less than 20%. Their standard treatment consists of surgical excision, in those locations where it is feasible, followed by radiotherapy (RT). In the absence of feasibility of surgical removal, a surgical biopsy is carried out to enable diagnosis. Radiotherapy is then performed alone or in association with chemotherapy and/or other medical treatments.

"This collaboration represents another clinical milestone for Onxeo and reflects the Company’s commitment to evaluate its drug candidate in indications with very high medical need, which is the case for this indication with a poor prognosis. The aim is to evaluate the synergy of the combination of AsiDNA with radiotherapy in order to improve treatment outcomes for these children suffering from relapsing High-Grade Glioma," said Olivier de Beaumont, Chief Medical Officer of Onxeo. "We are excited and honored to be collaborating with the teams at Institut Curie, a world-renowned academic institution that we would like to thank, as well as the teams of Fight Kids Cancer for their support in this research aimed at improving the care of these children."

"We look forward to start this original proof-of-concept study of the systemic administration of AsiDNA in combination with radiotherapy in this disease with a poor prognosis: the development of new treatments meets a major need. This first study is supported by a grant from the European Fight Kids Cancer program, which we thank for their support, and is being conducted within the framework of the European ITCC[2] consortium. High-grade gliomas in children are a particularly severe disease and the treatments available are limited in terms of their efficacy but also in terms of their potential toxicity on the brain. Combined with radiotherapy, AsiDNA could represent a real therapeutic breakthrough, bringing together greater efficacy with a very reassuring tolerance profile", said François Doz, MD, PhD, pediatrician oncologist, deputy director of clinical research, innovation and teaching at the SIREDO (Care, Innovation, Research, in oncology of children, adolescents and young adults) of Institut Curie and principal investigator of the study.

He concludes: "We are delighted with this clinical development in pediatric oncology of AsiDNA, an innovative therapy resulting from the work of Marie Dutreix’s research laboratory at Institut Curie. If this study is positive, it could pave the way for further studies in association with radiotherapy, in children with brain tumors".

Surgery, when possible, and radiotherapy, sometimes combined with chemotherapy, often allow control of the disease in high-grade gliomas in children, but this control is inconsistent and most usually transient because the tumors evolve secondarily due to the development of resistant tumor cells. In preclinical and clinical studies[3], the synergistic effect of AsiDNA in combination with "DNA breakers" such as radiotherapy has been demonstrated. Institut Curie and Onxeo collaborated on this multi-center phase 1b/2 trial design. Institut Curie, as study sponsor, will submit the application for authorization of this trial to the health authorities and ethics committees in the coming weeks, with the aim of initiating the study as early as 2021.

[1] Fight Kids Cancer is a European call for projects, a joint initiative of the French association Imagine for Margo, the Belgian KickCancer Foundation and the Luxembourg Kriibskrank Kanner Foundation.

[2] Innovative Therapies for Children with Cancer (ITCC) Consortium : www.itcc-consortium.org

[3] First-in-human phase I study of the DNA repair inhibitor DT01 in combination with radiotherapy in patients with skin metastases from melanoma. Le Tourneau C et al. Br J Cancer. 2016 May 24;114(11):1199-205