On April 14, 2021 NantHealth, Inc. (NASDAQ-GS: NH), a provider of enterprise solutions that help transform complex data into actionable insights, reported the signing of a new financing that will include the issuance of $137.5 million aggregate principal amount of new senior unsecured convertible notes due 2026 (the "2026 Notes") in a private transaction, with the common stock that may be issued upon a conversion to be registered under the Securities Act of 1933, as amended (the "Securities Act") (Press release, NantHealth, APR 14, 2021, View Source [SID1234578015]). As part of the transaction, the company will enter into an agreement to extend the maturity of its existing subordinated note to October 2026. The company intends to use the proceeds of the 2026 Notes to retire its existing convertible notes due December 2021 (the "2021 Notes") and further invest in initiatives to grow its business.

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The 2026 Notes will be issued to two existing NantHealth investors: certain funds managed by Highbridge Capital Management, LLC ("Highbridge"), a current holder of the company’s 2021 Notes, and Nant Capital, LLC, an affiliated entity owned by the company’s majority equity investor and holder of the company’s subordinated notes. The investors will purchase $137.5 million in aggregate principal amount of the 2026 Notes. The parties expect the 2026 Notes financing transaction to close on or before April 27, 2021.

In addition, each of Highbridge and Cambridge Equities, LP (also an affiliate owned by the company’s majority shareholder), have agreed to convert $5 million ($10 million in total) of their holdings of the 2021 Notes to shares of NantHealth common stock on April 14, 2021.

"This transaction provides several immediate benefits to NantHealth, including enhancing our financial flexibility and funding our growth initiatives," said Ron Louks, NantHealth’s Chief Operating Officer. "Not only does this financing address the upcoming maturity of our 2021 Notes, but importantly provides us with the resources to invest in our established businesses, NaviNet and Eviti, and accelerate the expansion of our recently acquired OpenNMS business. We thank our financing partners, Highbridge and Nant Capital, for their continued support."

Jonathan Segal, Co-Chief Investment Officer of Highbridge, said, "We are very pleased to increase our investment in NantHealth. Last year, NantHealth made a strategic decision to expand beyond healthcare by providing enterprise solutions to help businesses in other industries. We believe this financing will help NantHealth achieve this goal and continue further product expansion."

The 2026 Notes will bear interest of 4.5% that will be payable semiannually, unless earlier converted to the company’s common stock, redeemed or repurchased in accordance with their terms. The final terms of the 2026 Notes, including the interest rate, initial conversion rate, and other terms, will be disclosed in the company’s filings with the U.S. Securities and Exchange Commission (SEC).

A Special Committee of the NantHealth Board of Directors, consisting of the independent directors, undertook a thorough review of the transaction and unanimously recommended that NantHealth proceed with the transaction.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the 2026 Notes, nor shall there be any sale of the notes in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

On April 14, 2021 Vascular Biogenics Ltd. ("VBL Therapeutics" or the "Company") (NASDAQ: VBLT), reported the closing of its underwritten public offering of 6,901,790 ordinary shares, and, to certain investors in lieu thereof, pre-funded warrants to purchase 8,050,000 ordinary shares in an underwritten public offering, at a price to the public of $1.90 per ordinary share and $1.89 per pre-funded warrant (Press release, VBL Therapeutics, APR 14, 2021, View Source [SID1234578014]). The pre-funded warrants allow investors that have restrictions on their ability to own Company stock above a designated ownership threshold (such as 4.99% or 19.99%) to invest additional capital. In practice, the pre-funded warrants are the equivalent to ordinary shares without voting rights. All of the securities in the offering were sold by VBL Therapeutics.

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The gross proceeds to the Company from the public offering, before deducting underwriting discounts and commissions and offering expenses payable by VBL Therapeutics, were approximately $28.3 million. VBL Therapeutics intends to use the net proceeds from the offering for working capital and other general corporate purposes.

Guggenheim Securities, LLC acted as bookrunning manager for the offering. Oppenheimer & Co. Inc. also acted as a joint bookrunner. Roth Capital Partners and JonesTrading Institutional Services LLC acted as co-managers.

The securities described were offered by VBL Therapeutics pursuant to a shelf registration statement on Form F-3 (No. 333-251821), including a base prospectus, previously filed with and declared effective by the Securities and Exchange Commission (the "SEC"). A preliminary prospectus supplement and a final prospectus supplement relating to and describing the terms of the offering has been filed with the SEC. The final prospectus supplement is available on the SEC’s website located at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the securities being offered may also be obtained by contacting Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, New York 10017, by telephone at (212) 518-9544, or by email at [email protected].

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

On April 14, 2021 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported the publication of a second poster for the GP2 Phase III clinical trial design for recurring breast cancer at the 2021 AACR (Free AACR Whitepaper) Annual Meeting (Press release, Greenwich LifeSciences, APR 14, 2021, View Source [SID1234578013]). The Global Principal Investigator of the GP2 Phase III clinical trial, Dr. Mothaffar F. Rimawi of the Dan L Duncan Comprehensive Cancer Center at Baylor College of Medicine, is the lead author of the poster and has recorded an audio track providing an overview.

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Poster Presentation CT256 from 2021 AACR (Free AACR Whitepaper) Annual Meeting Showing GP2 Phase III Clinical Trial Design for Recurring Breast Cancer (Graphic: Business Wire)

Poster Presentation CT256 from 2021 AACR (Free AACR Whitepaper) Annual Meeting Showing GP2 Phase III Clinical Trial Design for Recurring Breast Cancer (Graphic: Business Wire)

The AACR (Free AACR Whitepaper) published the Phase III trial design abstract on April 9, 2021 and the poster on April 10, 2021. The abstract can be viewed at the bottom of this press release and the full poster with audio can be accessed or downloaded on the Company website at View Source

Snehal Patel, CEO of Greenwich LifeSciences, commented, "At present, the Phase III trial is designed to treat up to 500 patients. The data read out for the interim analysis will be event driven and could be completed approximately halfway through the planned 5 year follow-up. The recently reported robust immune response data, which peaked after 6 months in the Phase IIb trial, will help to finalize the Phase III trial design, including the immune response monitoring strategy. We will also assess immune response in an open-label third arm across multiple HLA types to potentially expand the market for GP2. This immune response data could be reported before the interim analysis."

Updated Phase III Clinical Trial Design: The Company and the Baylor College of Medicine presented the updated design of the planned Phase III clinical trial to breast cancer key opinion leaders. The Phase III clinical trial is a prospective, randomized, double-blinded, multi-center trial. The primary efficacy endpoints for the three arms of the Phase III trial are invasive Disease Free Survival (iDFS). The objective is to conservatively reproduce the Phase IIb trial results which demonstrated 100% iDFS with 5 years of follow-up in the HER2/neu 3+ population.

In addition to the trial design updates in the bullet points above, patients meeting all entry criteria will be randomized to receive either GP2 + GM-CSF or placebo. The Phase III trial design includes the use of saline in the placebo arm, instead of GM-CSF, which was used in the placebo arm of the Phase IIb trial. GM-CSF is not the standard of care and may cause immune responses in placebo patients.

Dr. Jaye Thompson, VP of Clinical and Regulatory Affairs, added, "It is critical that the study population and design in the protocol are carefully crafted so that the resulting data provides convincing evidence of safety and efficacy for the BLA submission. We have already engaged a statistician to design the interim analysis and have begun recruiting clinicians and clinical sites for participation in the Phase III trial."

AACR Abstract CT256

Title: A prospective, randomized, multicenter, double-blinded, placebo-controlled phase III trial of the HER2/neu peptide GP2 + GM-CSF versus bacteriostatic saline/WFI placebo as adjuvant therapy after any trastuzumab-based therapy in HER2-positive women with operable breast cancer

Snehal S Patel1, David B McWilliams1, Christine T Fischette1, Jaye Thompson1, F Joseph Daugherty1, C Kent Osborne2 and Mothaffar F Rimawi2.

1Greenwich LifeSciences, Stafford, TX; 2Baylor College of Medicine, Houston, TX

Background: GP2 is a biologic nine amino acid peptide of the HER2/neu protein delivered in combination with an FDA-approved immunoadjuvant Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF, Sargramostim, Leukine) that stimulates an immune response targeting HER2/neu expressing cancers. In a prospective, randomized, single-blinded, placebo-controlled, multicenter Phase IIb clinical trial completed in 2018, no recurrences were observed in the HER2/neu positive adjuvant setting after median 5 years of follow-up, if the HLA 2+ patient received the 6 primary intradermal injections over the first 6 months (p = 0.0338) in a pre-specified subgroup analysis. Furthermore, the GP2 immunotherapy elicited a potent immune response measured by local skin tests and immunological assays. Of the 138 patients that have been treated with GP2 to date over 4 clinical trials, GP2 treatment was well tolerated and no serious adverse events were observed related to the GP2 immunotherapy. This Phase III trial aims to reproduce the Phase IIb study and will explore the use of GP2 + GM-CSF as adjuvant therapy to prevent the recurrence of breast cancer in HER2/neu positive and HLA 2+ patients, post-surgery and following the first year treatment with any trastuzumab-based therapy.

Trial Design: This Phase III trial is a prospective, randomized, double-blinded, multi-center study. After 1 year of trastuzumab-based therapy or an approved biosimilar, treatment with GP2 + GM-CSF or placebo (Bacteriostatic Saline/WFI) will be administered intradermally for the 6 primary immunization series over the first 6 months and 5 subsequent boosters over the next 2.5 years for a total of 11 injections over 3 years of treatment. The participant duration of the trial will be 3 years treatment plus 2 years follow-up for a total of 5 years following the first year treatment with trastuzumab-based therapy or approved biosimilar. An interim analysis is planned and patients will be stratified based on prior and current treatments, among other factors.

Eligibility Criteria: The majority of breast cancer patients will be HER2/neu positive and HLA 2+, disease-free, conventionally treated node-positive, post breast tumor removal surgery and following the first year treatment with trastuzumab-based therapy.

Trial Objectives:

To determine if GP2 therapy reduces recurrence in HER2/neu positive breast cancer patients.
To monitor the in vitro and in vivo immunologic responses to GP2 therapy and correlate these responses with the clinical outcomes.
To monitor for any unexpected adverse events and toxicities related to GP2 therapy.
Accrual: The target enrollment is up to approximately 500 patients.

Funding: This trial is supported by Greenwich LifeSciences.

About the AACR (Free AACR Whitepaper) Annual Meeting 2021

The AACR (Free AACR Whitepaper) is the first and largest cancer research organization dedicated to accelerating the conquest of cancer and has more than 48,000 members residing in 127 countries and territories. The AACR (Free AACR Whitepaper) Annual Meeting program covers the latest discoveries across the spectrum of cancer research — from population science and prevention; to cancer biology, translational, and clinical studies; to survivorship and advocacy — and highlights the work of the best minds in research and medicine from institutions all over the world.

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 266,000 new breast cancer patients and 3.1 million breast cancer survivors in 2018. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

On April 14, 2021 Hutchison China MediTech Limited ("HUTCHMED") (Nasdaq/AIM: HCM) reported that it was notified that CK Hutchison Holdings Limited ("CK Hutchison") shareholding[1] in HUTCHMED remains unchanged, at 332,478,770 ordinary shares of par value US$0.10 each in the capital of HUTCHMED ("Shares") (Press release, Hutchison China MediTech, APR 14, 2021, View Source [SID1234578012]).

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Each American Depositary Share ("ADS") represents five Shares. As announced on April 8, 2021, HUTCHMED issued a total of 16,393,445 Shares (equivalent to 3,278,689 ADSs) to funds affiliated with Baring Private Equity Asia. HUTCHMED was notified on April 14, 2021 that this issuance diluted CK Hutchison’s holding[1] to 44.66 per cent of the total number of voting rights of HUTCHMED. The date on which the notification threshold was crossed was April 14, 2021.

[1] Held through CK Hutchison’s indirect wholly-owned subsidiary Hutchison Healthcare Holdings Limited.

On April 14, 2021 AstraZeneca reported that Tagrisso (osimertinib) has been approved in China for the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after tumour resection with curative intent, with or without adjuvant chemotherapy as recommended by the patient’s physician (Press release, AstraZeneca, APR 14, 2021, View Source [SID1234578011]). Tagrisso is indicated for EGFRm patients whose tumours have exon 19 deletions or exon 21 (L858R) mutations.

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The approval by China’s National Medical Products Administration (NMPA) was based on positive results from the ADAURA Phase III trial. In the trial, Tagrisso demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS) in the primary analysis population of patients with Stage II and IIIA EGFRm NSCLC. The ADAURA trial also showed a statistically significant and clinically meaningful improvement in DFS in the overall trial population of patients with Stage IB-IIIA disease, a key secondary endpoint.

While up to 30% of all patients with NSCLC may be diagnosed early enough to have surgery with curative intent, recurrence is still common in early-stage disease. Historically, nearly half of patients diagnosed in Stage IB, and over three quarters of patients diagnosed in Stage IIIA, have experienced recurrence within five years.1-3 More than a third of the world’s lung cancer patients are in China and among those with NSCLC, approximately 40% have tumours with an EGFR mutation.4-6

Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: "The expedited approval of Tagrisso in China as part of a curative-intent regimen for early-stage EGFR-mutated lung cancer underscores the high unmet need in this setting and our commitment to improving outcomes in a country with one of the highest rates of EGFR mutations in the world. This approval reinforces the importance of EGFR testing across all stages of lung cancer, prior to treatment decisions, to ensure as many patients as possible can benefit from targeted therapies like Tagrisso and live cancer-free longer."

In the ADAURA trial, adjuvant treatment with Tagrisso reduced the risk of disease recurrence or death by 83% in patients with Stage II and IIIA disease (hazard ratio [HR] 0.17; 99.06% confidence interval [CI] 0.11-0.26; p<0.001) and by 80% in the overall trial population of patients with Stage IB-IIIA disease (HR 0.20; 99.12% CI 0.14-0.30; p<0.001).

Consistent DFS results were seen regardless of prior adjuvant chemotherapy use and across all prespecified subgroups, including in Asian and non-Asian patients. The safety and tolerability of Tagrisso in this trial was consistent with previous trials in the metastatic setting. The ADAURA results were published in The New England Journal of Medicine.

Tagrisso is approved to treat early-stage lung cancer in more than a dozen countries, including the US, and additional global regulatory reviews are ongoing. Tagrisso is also approved for the 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC and for the treatment of locally advanced or metastatic EGFR T790M mutation-positive NSCLC in China, and in the US, Japan, the EU and many other countries.

This approval follows a priority review designation by the NMPA’s Center for Drug Evaluation. It marks the third approved indication for Tagrisso in China following previous approvals in 2nd-line T790M and 1st-line EGFRm NSCLC, which are both included on the National Reimbursement Drug List.

Lung cancer
Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths.4 Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% classified as NSCLC.7 The majority of NSCLC patients are diagnosed with advanced disease while approximately 25-30% present with resectable disease at diagnosis.1-2 Early-stage lung cancer diagnoses are often only made when the cancer is found on imaging for an unrelated condition.8-9

For patients with resectable tumours, the majority of patients eventually develop recurrence despite complete tumour resection and adjuvant chemotherapy.3

Approximately 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFRm NSCLC.10-12 These patients are particularly sensitive to treatment with an EGFR-tyrosine kinase inhibitor (TKI) which blocks the cell-signalling pathways that drive the growth of tumour cells.13

ADAURA
ADAURA is a randomised, double-blind, global, placebo-controlled Phase III trial in the adjuvant treatment of 682 patients with Stage IB, II and IIIA EGFRm NSCLC following complete tumour resection and adjuvant chemotherapy as indicated. Patients were treated with Tagrisso 80mg once-daily oral tablets or placebo for three years or until disease recurrence.

The trial enrolled patients in more than 200 centres across more than 20 countries, including the US, in Europe, South America, Asia and the Middle East. The primary endpoint was DFS in Stage II and IIIA patients and a key secondary endpoint was DFS in Stage IB, II and IIIA patients.

The data readout was originally anticipated in 2022. In April 2020, an Independent Data Monitoring Committee recommended for the trial to be unblinded two years early based on a determination of overwhelming efficacy. Investigators and patients continue to participate and remain blinded to treatment. The trial will continue to assess overall survival.

Tagrisso
Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI with clinical activity against central nervous system metastases. Tagrisso (40mg and 80mg once-daily oral tablets) has been used to treat approximately 250,000 patients across indications worldwide and AstraZeneca continues to explore Tagrisso as a treatment for patients across multiple stages of EGFRm NSCLC.

In Phase III trials, Tagrisso is being tested in the Stage III locally advanced unresectable setting (LAURA), in the neoadjuvant resectable setting (NeoADAURA) and in combination with chemotherapy (FLAURA2). AstraZeneca is also researching ways to address tumour mechanisms of resistance through the SAVANNAH and ORCHARD Phase II trials, which test Tagrisso given concomitantly with savolitinib, an oral, potent and highly selective MET TKI, as well as other potential new medicines.

AstraZeneca in lung cancer
AstraZeneca has a comprehensive portfolio of approved and potential new medicines in late-stage development for the treatment of different forms of lung cancer spanning different histologies, stages of disease, lines of therapy and modes of action. These medicines include Tagrisso, Imfinzi (durvalumab), Enhertu (trastuzumab deruxtecan), datopotamab deruxtecan and savolitinib.

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.