On April 22, 2021 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) (the "Company" or "Jazz") reported the pricing of the previously announced offering (the "Offering") of $1.5 billion in an aggregate principal amount of 4.375% senior secured notes due 2029 (the "Notes") by Jazz Securities Designated Activity Company, a direct wholly owned subsidiary of the Company (the "Issuer") (Press release, Jazz Pharmaceuticals, APR 22, 2021, View Source [SID1234578382]). The Notes will mature on January 15, 2029 and will bear an interest rate of 4.375%. The Notes will be guaranteed by the Company and certain of its subsidiaries. The Offering is expected to close on April 29, 2021 subject to customary closing conditions.

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The aggregate principal amount of the Notes to be issued in the Offering decreased to $1.5 billion from the anticipated $2.7 billion announced on April 20, 2021, a decrease of $1.2 billion. This reduction corresponds to the equivalent anticipated increase in term loan borrowings under our new senior secured credit facilities (the "New Senior Secured Credit Facilities") in connection with the previously announced proposed acquisition of GW Pharmaceuticals plc ("GW") (the "Acquisition") from $2.65 billion to approximately $3.85 billion.

The Company expects to use the net proceeds from the Notes and Acquisition date borrowings under the new senior secured credit facilities, together with cash on hand to fund the cash consideration payable in connection with the Acquisition of GW, the refinancing of certain of the Company’s indebtedness (including the Company’s existing senior secured credit facility) and fees and expenses in connection with the foregoing. The Offering is not conditioned on the closing of the Acquisition. If (1) the Acquisition is consummated without the Company entering into the New Senior Secured Credit Facilities, (2) the Acquisition has not been consummated on or before August 3, 2021 (or such later date to which such date may be extended pursuant to the terms of the Transaction Agreement, dated February 3, 2021, among the Company, GW and Jazz Pharmaceuticals UK Holdings Limited (the "Transaction Agreement") or (3) the Transaction Agreement is terminated in accordance with its terms, the Issuer will be required to redeem all of the Notes at a redemption price equal to 100% of their principal amount plus accrued and unpaid interest to, but excluding, the redemption date.

The Notes will be offered and sold only to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the U.S. Securities Act of 1933, as amended (the "Securities Act") that are located in the United States, Canada, France, Ireland, Luxembourg, the United Kingdom, and Bermuda and to certain non-U.S. persons outside the United States pursuant to Regulation S under the Securities Act that are located in Canada, France, Ireland, Luxembourg, the United Kingdom, and Bermuda. The Notes have not been registered under the Securities Act or any state securities law and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state laws.

This press release does not constitute an offer to sell or a solicitation of an offer to purchase the Notes or any other securities and does not constitute an offer, solicitation or sale in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful.

On April 22, 2021 Vyant Bio, Inc. ("Vyant" or the "Company") (Nasdaq: VYNT), an emerging leader in novel drug discovery techniques, reported a collaboration that will seek to de-risk the development of small protein therapeutics (Press release, Cellaria, APR 22, 2021, View Source [SID1234578443]). In partnership with Ordaōs Bio ("Ordaōs") and Cellaria, Inc. ("Cellaria"), the Company is unveiling a model for rapid iteration of therapeutic design using artificial intelligence and in vitro ‘avatar clinical trials’ that will enable the design, development, and testing of potential therapeutics on specific patient populations, during preclinical development. The goal is to provide an early detection system of a drug’s efficacy in different patient cohorts, prior to clinical trials.

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The collaboration capitalizes on the unique capabilities of each company to design, manufacture, and test small-protein therapeutics that target multiple biomarkers derived from whole genome sequencing of patient populations. Using proprietary AI, Ordaōs will generate in silico protein sequences, designed to bind specific disease targets, and will serve as a blueprint for the collaborative team’s experts in in vitro and in vivo preclinical drug discovery, to produce the protein and rapidly iterate the structure using a highly efficient expression system. Using Cellaria’s Patient Specific Cell Model Cohorts, the purified protein will be critically evaluated for target binding and further optimized to improve performance across an array of disease-specific genetic biomarker expressing cells. Once fully optimized by the team, Vyant Bio’s objective will be to deliver regulatory readiness and a maximally de-risked drug candidate. The combined solution will provide data and human-based insights not usually available until after a costly clinical trial.

"Vyant Bio is committed to transforming the way that drugs are discovered by quickly adapting to exciting new technologies and combining capabilities in ways that leverage their strengths," stated Jay Roberts, CEO of Vyant Bio. "Our collaboration with Ordaōs and Cellaria allows us all to work together to design and develop superior therapeutics and position them to be as successful as possible before they get into the clinic."

Cellaria Inc. uses cell biology in novel ways to provide insights into how a therapeutic may perform in specific patient populations, prior to clinical trials. In this collaboration, Cellaria provides the means for scientists to test how a drug will perform in a range of patient cohorts. The Cellaria in vitro and 3-D Models of tumor and metastatic niches are directly linked to a patient’s disease state and enable multiple parametric deep data sets in genomics, proteomics, and combinatorial analysis.

"Working with the Ordaōs and Vyant Bio teams has been incredibly important for us. Seeing the wealth of patient data and cells used so seamlessly to inform and guide the design of a therapeutic is highly rewarding," stated David Deems, President and Founder of Cellaria Inc. "We are developing a repeatable process that leverages well defined patient cohorts to learn as much as possible prior to embarking on a clinical trial."

Ordaōs uses generative AI technology to accelerate the mini protein drug discovery and development process. In this collaboration, Ordaōs provides a pipeline of digitally optimized therapeutics for further development. The company was founded by David Longo, a Stanford and Harvard-trained AI and biotech scientist, and Ulo Palm, MD, PhD, a 30-year veteran of clinical drug discovery and development at Allergan, Novartis, and Schering Plough.

"We are very excited about working with Vyant Bio and Cellaria to further our vision for transforming the way we bring therapeutics to patients. At Ordaōs, we believe that designing, rather than discovering, drugs is now possible with AI and will allow us to think bigger when we envision the impact we can have on people’s lives." said David Longo, CEO of Ordaōs.

Ülo Palm, Ordaōs’ Chief Medical Officer, added that "the ultimate goal is to use modern AI to design the next generation of highly effective and safe biologics for treating cancer and inflammatory diseases thereby creating transformative treatment options for potentially millions of patients worldwide. We expect that this new approach will significantly accelerate drug R&D overall and get the new drugs to patients much faster than with the traditional drug development approach. Patients who suffer from chronic and life-threatening diseases cannot wait. That is why this new collaboration is so important."

The three companies will continue to refine their strategies for drug design and development through a series of projects targeting cancer, pancreatic, and autoimmune disorders. As the project evolves, the therapeutic de-risking strategy will further incorporate the human-based biology and analytical software of StemoniX, a wholly owned subsidiary of Vyant Bio.

On April 22, 2021 Roche (SIX: RO, ROG; OTCQX: RHHBY) and GenMark Diagnostics, Inc. reported that Roche’s wholly owned subsidiary Geronimo Acquisition Corp. has accepted for payment all shares validly tendered and not validly withdrawn pursuant to its tender offer for all outstanding shares of common stock of GenMark Diagnostics, Inc. (NASDAQ: GNMK) at a price of USD 24.05 per share in cash (Press release, Hoffmann-La Roche, APR 22, 2021, View Source [SID1234578333]). The tender offer expired at 12:00 midnight, Eastern Time, at the end of the day on 21 April 2021 and was not extended.

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Roche has been advised by Citibank, N.A., the depositary for the tender offer, that a total of approximately 61,201,761 shares of GenMark’s common stock were validly tendered and not validly withdrawn in the tender offer (excluding shares tendered by notice of guaranteed delivery for which certificates have not yet been "received"), which represent approximately 82.89% of the total number of shares of GenMark’s common stock outstanding.

Later today, Roche intends to complete the acquisition of GenMark through a merger of Geronimo Acquisition Corp. with and into GenMark without a vote or meeting of GenMark’s stockholders. In the merger, all shares of GenMark not owned by GenMark, Roche or Roche’s wholly owned subsidiaries (other than shares as to which appraisal rights have been validly exercised under Delaware law) will be converted into the right to receive the same cash consideration per share, less any applicable withholding taxes, as was paid in the tender offer. Following completion of the merger, GenMark will become a wholly owned subsidiary of Roche, and GenMark’s shares will cease to be traded on the NASDAQ Stock Market.

"We are excited about this important milestone, as this acquisition will support our long-lasting commitment to help control antibiotic resistance and infectious diseases, which are a leading cause of death globally," said Thomas Schinecker, CEO Roche Diagnostics. "The addition of GenMark Diagnostics’ proprietary multiplex technology, which is designed to detect multiple pathogens from a single patient sample, will broaden our best-in-class molecular diagnostics portfolio to help make lifesaving information available to healthcare providers quickly to improve patient outcomes."

On April 22, 2021 ASLAN Pharmaceuticals (Nasdaq:ASLN), a clinical-stage immunology focused biopharmaceutical company developing innovative treatments to transform the lives of patients, reported financial results for the fourth quarter and full year ended December 31, 2020 and provided an update on its clinical development activities (Press release, ASLAN Pharmaceuticals, APR 22, 2021, View Source [SID1234578351]).

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Dr Carl Firth, Chief Executive Officer, ASLAN Pharmaceuticals, said: "ASLAN made significant progress in the fourth quarter of 2020 and that momentum has carried over into 2021. After completing recruitment of the third cohort in our multiple ascending dose trial for ASLAN004 in the fourth quarter, we announced positive interim data supportive of its potential as a novel, first-in-class antibody targeting IL-13R with a differentiated efficacy and safety profile in atopic dermatitis. We are on track to complete enrolment of the expansion cohort with an additional 27 patients by mid-2021 and anticipate reporting topline data in the third quarter of 2021. At the same time, we are continuing to prepare for our Phase 2b study, which we expect to initiate in the second half of 2021. ASLAN is in a strong financial position with the necessary resources to fund its development activities to achieve important value creating milestones for shareholders."

Fourth quarter 2020 and recent business highlights

Clinical development

ASLAN004

In March 2021, ASLAN announced positive interim unblinded data from the three dose cohorts of the ongoing Phase 1 randomised, double-blind placebo controlled multiple ascending dose (MAD) study of ASLAN004 for the treatment of moderate to severe atopic dermatitis (AD). ASLAN004, a novel, first-in-class antibody, was well tolerated across all doses and showed improvements compared to placebo in all efficacy endpoints, supporting its potential as a differentiated treatment for AD.
ASLAN003

New data from a study conducted by the University of Liverpool, UK, published in the Toxicology in Vitro Journal, demonstrated that, out of a panel of six dihydroorotate dehydrogenase (DHODH) inhibitors tested, ASLAN003 has the lowest potential for hepatotoxicity despite being one of the most potent inhibitors of DHODH.
Corporate updates

In March 2021, raised gross proceeds of approximately US$69 million, including the full exercise of an over-allotment option, through an underwritten public offering of 17,250,000 American Depositary Shares (ADSs) representing 86,250,000 ordinary shares at a price to the public of US$4.00 per ADS.
In February 2021, raised gross proceeds of approximately US$18 million resulting from the sale of its ordinary shares through a private placement to new institutional investors, Vivo Capital and Surveyor Capital (a Citadel company).
Between October 2020 and February 2021, raised gross proceeds of approximately US$21.5 million through at-the-market offerings.
Appointed Neil Graham, MBBS, MD, MPH and Kathleen M. Metters, PhD as independent directors. Dr Graham is an expert in immunology and inflammation with more than 30 years’ experience in global drug development and commercialisation, including 10 years at Regeneron Pharmaceuticals, Inc., where he was instrumental in the development of dupilumab. Dr Metters has more than 30 years’ experience in the discovery and development of novel therapies for the treatment of chronic diseases, including autoimmune diseases. She held a number of senior positions at Merck & Co., previously leading work on External Discovery and Preclinical Sciences and was Senior Vice President and Head of Worldwide Basic Research.
Anticipated upcoming milestones

Completion of MAD clinical study of ASLAN004 in moderate-to-severe AD patients and topline clinical results expected in the third quarter of 2021.
Initiation of Phase 2b study of ASLAN004 for AD expected in the second half of 2021.
Fourth quarter 2020 financial highlights

Cash used in operations for the fourth quarter of 2020 was US$5.1 million compared to US$5.1 million in the same period in 2019.
Research and development expenses were US$2.9 million in the fourth quarter of 2020 compared to US$2.7 million in the fourth quarter of 2019.
General and administrative expenses were US$3.0 million in the fourth quarter of 2020 compared to US$3.3 million in the fourth quarter of 2019.
Net loss for the fourth quarter of 2020 was US$5.7 million compared to a net loss of US$29.6 million for the fourth quarter of 2019, which included a one-time impairment charge of US$23 million related to the write-down of varlitinib in the fourth quarter of 2019.
Full year 2020 financial highlights

Cash used in operations for the year ended 31 December 2020 was US$15.1 million compared to US$25.8 million in 2019.
Research and development expenses were US$9.3 million for the full year 2020 compared to US$16.6 million in 2019. The decrease was driven by the completion of clinical studies related to varlitinib.
General and administrative expenses were US$7.2 million for the full year 2020 compared to US$8.5 million in 2019.
Net loss attributable to stockholders for the full year 2020 was US$16.2 million compared to a loss of US$47.0 million in 2019, which included a one-time impairment charge of US$23 million related to the write-down of varlitinib in the fourth quarter of 2019. Excluding the non-cash impairment charge, net loss for the full year 2019 was US$23.9 million.
Cash and cash equivalents totaled US$14.3 million as of 31 December 2020, including US$7.4 million raised from at-the-market offerings in 2020, compared to US$22.2 million as of 31 December 2019. The cash balance as of year-end 2020 excludes proceeds from the additional financing activities completed in the first quarter of 2021 which raised combined gross proceeds of approximately US$101 million. With the additional financing activities in the first quarter of 2021, management believes that its cash and cash equivalents will be sufficient to fund operations into 2023.The weighted average number of ADSs outstanding for the year 2020 was 38.4 million compared to 32.5 million for 2019. One ADS is the equivalent of five ordinary shares.

On April 22, 2021 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in cell therapy to treat cancer, reported that it will report financial results and provide a business update for the first quarter ended March 31, 2021, before the US markets open on Thursday, May 6, 2021 (Press release, Adaptimmune, APR 22, 2021, View Source [SID1234578367]). Following the announcement, the Company will host a live teleconference and webcast at 9:00 a.m. EDT (2:00 p.m. BST) that same day (details below).

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The press release will be available in the investor section of Adaptimmune’s corporate website at www.adaptimmune.com. A live webcast of the conference call and replay can be accessed at https://bit.ly/2Ry9DdR.

To participate in the live conference call, please dial (833) 652-5917 (U.S. or Canada) or
+1 (430) 775-1624 (International). After placing the call, please ask to be joined into the Adaptimmune conference call and provide the confirmation code (9271335).