On May 17, 2021 Clovis Oncology, Inc. (NASDAQ:CLVS) reported that it has filed a prospectus supplement with the U.S. Securities and Exchange Commission ("SEC"), under which it may offer and sell, from time to time, shares of its common stock having an aggregate offering price of up to $75,000,000 million through an "at-the-market" equity offering program (the "ATM Program") (Press release, Clovis Oncology, MAY 17, 2021, View Source [SID1234580117]). The timing and amount of any sales will be determined by a variety of factors considered by Clovis Oncology.

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Shares of Clovis Oncology common stock will be offered through J.P. Morgan Securities LLC ("JPM") and BofA Securities, Inc. ("BofA Securities"), who are serving as the distribution agents. JPM and BofA Securities may sell the shares of our common stock by any method deemed to be an "at-the-market offering" defined by Rule 415(a)(4) of the Securities Act of 1933, as amended, including without limitation, sales in ordinary brokers’ transactions, including directly on the Nasdaq Global Select Market or into any other existing trading market for the shares, or to or through a market maker, in block transactions or by any other method permitted by law, including negotiated transactions and to JPM and BofA Securities as principals for their own account. Sales may be made at market prices prevailing at the time of a sale or at prices related to prevailing market prices or at negotiated prices. As a result, sales prices may vary.

Clovis Oncology intends to use the net proceeds from any sales of its common stock under the ATM Program for general corporate purposes, including funding of its development programs, sales and marketing expenses associated with Rubraca (rucaparib), repayment, repurchase or refinance of its debt obligations, payment of milestones pursuant to its license agreements, general and administrative expenses, acquisition or licensing of additional product candidates or businesses and working capital.

Clovis Oncology’s prospectus supplement filed today with the SEC supplements information contained in the accompanying prospectus contained in the shelf registration statement on Form S-3 (File No. 333-253485), as amended for the offering. Prospective investors should read the prospectus in that registration statement, the prospectus supplement and all other documents that Clovis Oncology has filed with the SEC for more complete information about Clovis Oncology, including information pertaining to the ATM Program and the risks associated with investing in Clovis Oncology. Copies of the prospectus supplement and related prospectus may be obtained from J. P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email to [email protected], or from BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte NC 28255-0001, Attn: Prospectus Department or by email to [email protected]. You may also obtain these documents free of charge when they are available by visiting EDGAR on the SEC’s website at www.sec.gov.

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

On May 17, 2021 Cernostics (View Source) a pioneer in delivering spatialomics to the clinic, reported that new results from clinical studies on the TissueCypher Barrett’s Esophagus Assay will be presented at Digestive Disease Week (DDW) 2021 taking place May 21-23 (Press release, Cernostics, MAY 17, 2021, View Source;utm_medium=rss&utm_campaign=digestive-disease-week-2021-to-showcase-the-tissuecypher-barretts-esophagus-assay [SID1234580116]).

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Clinical studies by Mayo Clinic, and Academic Medical Center in The Netherlands, two of the world’s leading academic institutions in the area of diagnosis and treatment of Barrett’s esophagus (BE) and esophageal cancer prevention, will be presented during the oral lecture session focused on predicting progression to esophageal cancer in patients with BE.

"New data accepted for presentation at this year’s DDW point to the value of TissueCypher for improving prevention of esophageal cancer, particularly to help physicians and patients make more informed management decisions based on the unique biology of individual patients’ esophageal biopsies," said Mike Hoerres, Cernostics’ chief executive officer. "We believe such data demonstrate the value of precision medicine testing with the TissueCypher Barrett’s Esophagus Assay, and greatly appreciate the Barrett’s esophagus clinical experts who led and participated in these studies."

Below are the details of the presentations on TissueCypher at DDW 2021:

TissueCypher Objectively Risk Stratifies Barrett’s Esophagus Patients with Low Grade Dysplasia (lecture presentation)

Presenter: Nicola Frei, MD (AMC, Amsterdam, Netherlands)

Session Title: Prediction of Progression in Barrett’s Esophagus

Session Date/Time: May 21, 2021, 10:00 AM to 11:30 AM EDT (UTC –4)

Prediction of Progression in Barrett’s Esophagus Using a Tissue Systems Pathology Test: A Pooled Analysis of International Multicenter Studies (lecture presentation)

Presenter: Prasad Iyer, MD (Mayo Clinic)

Session Title: Prediction of Progression in Barrett’s Esophagus

Session Date/Time: May 21, 2021, 10:00 AM to 11:30 AM EDT (UTC –4)

The AMC study, led by Professor Jacques Bergman, MD, PhD, evaluated the performance of the TissueCypher Barrett’s Esophagus Assay versus the independent scoring of expert and generalist pathologists in the USA and Europe in a cohort of 155 patients previously diagnosed with Low-Grade Dysplasia (LGD) in the community practice setting. TissueCypher demonstrated higher sensitivity and provided more objective risk stratification than the 12 participating pathologists, as well as identified a subset of progressor patients who had been down-staged to Non-dysplastic BE (ND BE) upon expert review.

The Mayo Study, led by Dr Prasad Iyer, MD, analyzed four independent clinical validation studies (475 patients, including 152 progressors) to assess the performance of TissueCypher in independently predicting incident progression. The results demonstrated TissueCypher outperformed the expert pathologist as well as commonly-used clinical variables in risk stratifying patients for progression. Importantly, this study also demonstrated that TissueCypher can identify high-risk progressor patients diagnosed with ND BE, and therefore can be missed by the standard of care.

Due to the dangers of esophageal cancer and the challenges in identifying those patients who will likely progress to it, the management of Barrett’s esophagus and predicting progression are two of the major Education Tracks in DDW 2021. Objectively and accurately predicting progression from ND BE to High-Grade Dysplasia (HGD) or esophageal adenocarcinoma (EAC) is critical as the incidence of esophageal cancers is growing at one of the fastest rates of all cancers, and once diagnosed, has extremely low survivability.

About Cernostics and TissueCypher Barrett’s Esophagus Assay

Cernostics applies spatial biology and biologically aware AI to tissue diagnostics, delivering precision diagnostic testing to patients and gastroenterologists. This technology was used to develop the TissueCypher Barrett’s Esophagus Assay, the world’s first precision medicine test that predicts future development of esophageal cancer in patients with Barrett’s esophagus. TissueCypher is a proprietary Laboratory Developed Test (LDT) with its own unique CPT PLA code (0108U), available only from Cernostics’ CLIA-certified pathology laboratory. TissueCypher has been on the Medicare Clinical Laboratory Fee Schedule since January 2021.

On May 17, 2021 Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company focused on becoming a leader in the development and commercialization of treatments for rare and orphan diseases, reported that members of its senior management team will participate in three upcoming virtual investor conferences (Press release, Cerecor, MAY 17, 2021, View Source [SID1234580115]).

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2021 RBC Capital Markets Global Healthcare Virtual Conference
Date: Tuesday, May 18, 2021
Time: 8:35 AM ET

Oppenheimer Rare & Orphan Disease Summit
Date: Friday, May 21, 2021
1×1 meetings only

Jefferies Virtual Healthcare Conference
Date: Wednesday, June 2, 2021
Time: 1:00 PM ET

A live webcast of the presentation at the 2021 RBC Capital Markets Global Healthcare Virtual Conference and the Jefferies Virtual Healthcare Conference can be accessed under the "News/Events" page in the Investors section of the Company’s website at www.cerecor.com.

On May 17, 2021 Vyant Bio, Inc. (the "Company") (Nasdaq: VYNT), is an innovative biotechnology company reported that focused on partnering with pharmaceutical and other biotechnology companies to identify novel and repurposed therapeutics through the integration of human-derived biology with data science technologies and IND-enabling expertise (Press release, Cancer Genetics, MAY 17, 2021, View Source [SID1234580114]).

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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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RECENT STRATEGIC AND OPERATIONAL HIGHLIGHTS IN Q-1 2021

■Rebranded the Company from Cancer Genetics to Vyant Bio (Nasdaq: VYNT)
■Completed merger with StemoniX, Inc.
■Completed two equity financing rounds to raise $27.5 million in cash, entered into Q2 with $33.1 million of cash on the balance sheet
■Investing in research and development to optimize drug discovery capabilities
■Launched commercial stage, novel disease models in Rett Syndrome and CDKL5
■Initially focusing on novel and repurposed drugs to treat Rett Syndrome and CDKL5

Jay Roberts, Chief Executive Officer of Vyant Bio stated, "in Q1 2021, we reached an important milestone with the closing of the merger with StemoniX, uniquely positioning the combined company to focus our business on discovering applications for novel and repurposed therapeutics. We believe that drug discovery needs to progressively evolve as we know the traditional methods and models for predicting safe and effective drugs have under-performed, as evidenced by the billions of dollars and years of time it takes to bring novel drugs to market. With this as a backdrop, we are focusing our business on converging an impactful approach to drug discovery with data science and biology-driven technologies at the core with engineering disciplines and regulatory expertise."

"Vyant Bio has commercialized the development, engineering and manufacturing of disease models, built on its induced pluripotent stem cell ("iPSC") technology, and has developed neural and cardiac screening platforms, which are used to screen novel and repurposed compound targets", stated Ping Yeh, Vyant Bio’s Chief Innovation Officer. "The most mature disease models are being used to find therapeutic candidates in the central nervous system with its microBrain, driven by a focus on Rett Syndrome and CDKL5 neurological disorders. With the addition of the vivoPharm cancer cell-line assets and scientific expertise in oncology, the Company believes it can also advance models targeting Glioblastoma and Parkinson’s disease. The team has also made progress with our microHeart platform, so we believe there will be continued interest from partners with an interest in Cardiac Fibrosis and Rett Syndrome", Mr. Yeh continued.

"Our human-derived models, combined with the latest data science and software techniques, can identify and rank order repurposed and novel compounds by target. In our current drug discovery efforts, we aim to leverage our iPSC technology to identify drug candidates for licensure or clinical development. We are in active discussions with prospective pharma partners to offer exclusive licenses to certain disease models, and expect to enter into similar license agreements for access to both novel and repurposed therapies. The Company is striving to receive a mix of upfront payments, licensing fees, milestone-based fees and ongoing royalty payments", Mr. Yeh concluded.

The Company filed its quarterly report for Q1 2021 on Form 10-Q today with the Securities and Exchange Commission. The Company formerly known as Cancer Genetics, Inc., StemoniX and CGI Acquisition, Inc. ("Merger Sub") entered into a merger agreement on August 21, 2020, which was amended on February 8, 2021 and February 26, 2021(as amended, the "Merger Agreement"). Pursuant to the terms of the Merger Agreement, Merger Sub was merged ("the Merger") with and into StemoniX on March 30, 2021, with StemoniX surviving the Merger as a wholly owned subsidiary of the Company. The Merger was accounted for as a reverse acquisition with StemoniX being the accounting acquirer of CGI using the acquisition method of accounting.

FIRST QUARTER 2021 FINANCIAL RESULTS

As StemoniX was deemed to have acquired CGI for accounting purposes and the Merger closed on March 30, 2021, the Company’s first quarter financial results are primarily the StemoniX operations.

Cash and cash equivalents totaled approximately $33.1 million as of March 31, 2021.

Total revenues increased 32%, or $54 thousand, to $222 thousand for the three months ended March 31, 2021, as compared with $168 thousand for the three months ended March 31, 2020.

Cost of goods sold – service aggregated $89 thousand and $132 thousand, respectively, for the three months ended March 31, 2021 and 2020, resulting in a cost of goods sold of 77% and 97%, respectively, of service revenues.

Cost of goods sold – product aggregated $396 thousand and $166 thousand for the three months ended March 31, 2021 and 2020, respectively, resulting in a cost of goods sold gross margin deficit of $290 thousand and $134 thousand. Our product manufacturing capabilities currently have excess capacity to support future growth.

Research and development expenses decreased by 19%, or $189 thousand to $820 thousand for the three months ended March 31, 2021 from $1.0 million for the three months ended March 31, 2020.

Selling, general and administrative expenses increased by 46%, or $383 thousand, to $1.2 million for the three months ended March 31, 2021, as compared with $833 thousand for the three months ended March 31, 2020.

Merger related costs for the three-month period ended March 31, 2021 were $2.1 million.

Total other expense for the three months ended March 31, 2021 was $2.9 million, which consisted of a number of non-recurring non-cash items related to the conversion of the StemoniX’s capital structure to StemoniX common stock and exchange for Company common stock.

On May 17, 2021 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage biotechnology company focused on discovering and developing novel small molecule drugs for the treatment of cancer and other life-threatening diseases, and Antengene Corporation, Ltd. (SEHK: 6996.HK), a leading clinical-stage R&D driven biopharmaceutical company focused on innovative medicines for oncology and other life-threatening diseases, reported an exclusive, worldwide license agreement for the development and commercialization of CB-708, Calithera’s small molecule inhibitor of CD73 (Press release, Calithera Biosciences, MAY 17, 2021, View Source [SID1234580113]).

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"This agreement validates the capabilities of our drug discovery engine and represents a significant milestone for our CD73 program," said Susan Molineaux, PhD, president and chief executive officer of Calithera. "Antengene brings significant enthusiasm and proven global capabilities to the development and future commercialization of CB-708, a potential best-in-class oral small molecule CD73 inhibitor. This licensing agreement enables the continued advancement of this promising program, while allowing Calithera to focus our resources on our more advanced clinical programs evaluating telaglenastat in non-small cell lung cancer and CB-280 in cystic fibrosis."

CB-708 is a highly potent, selective, orally-bioavailable small molecule inhibitor of CD73. Preclinical data presented at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting and the 2019 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting demonstrated that CB-708 has immune-mediated, single agent activity in syngeneic mouse tumor models. In preclinical studies, CB-708 was well-tolerated and showed enhanced anti-tumor activity when combined with either an anti-PD-L1 immunotherapy or with chemotherapeutic agents, such as oxaliplatin or doxorubicin. CB-708 has completed GLP toxicology studies and is poised to advance into clinical development.

"We are excited to continue the advancement of CB-708 through our deep experience in global clinical development and extensive track record in commercialization in major markets around the world," said Dr. Jay Mei, Founder and Chief Executive Officer of Antengene. "CB-708 is a highly differentiated oral small molecule CD73 inhibitor with best-in-class potential. Antengene will continue to complete the GMP manufacturing of CB-708 and advance it into clinical trials for the treatment of multiple cancers including solid tumors and hematologic malignancies. This agreement brings a great addition to our synergistic portfolio of 12 assets with combinatory potential, is a testament to our abilities in accelerating global development, and represents another step in realizing our mission of treating patients beyond borders."

Under the terms of the license agreement, Calithera will receive an upfront payment and potential development, regulatory and sales milestones of up to $255.0 million. Additionally, Calithera is eligible to receive tiered royalties on sales of the licensed product up to low double-digits. Antengene Investment Ltd, a wholly owned subsidiary of Antengene Corporation, will receive exclusive, worldwide rights to develop and commercialize CB-708.