On July 29, 2021 Centene Corporation (NYSE: CNC) ("Centene" or the "Company") reported that it has priced its previously announced underwritten public offering of $1,800,000,000 aggregate principal amount of senior notes (Press release, Centene , JUL 29, 2021, View Source [SID1234585408]). The $1,800,000,000 offering of senior notes will include $500,000,000 aggregate principal amount of additional 2.450% senior notes due 2028 (the "Additional 2028 Notes") at a premium to yield 2.31% and $1,300,000,000 aggregate principal amount of new 2.625% senior notes due 2031 (together with the Additional 2028 Notes, the "Notes"). The Additional 2028 Notes will have the same terms as the Company’s existing 2.450% senior notes due 2028 (the "Existing 2028 Notes"), other than the issue date and the issue price. The offering is expected to close on or about August 12, 2021, subject to customary closing conditions.

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Centene intends to use the net proceeds from the offering of the Notes, together with a portion of the proceeds of certain term loans under the Company’s proposed amended and restated credit agreement and cash on hand to redeem all of its outstanding 5.375% senior notes due 2026 and all of WellCare Health Plans, Inc.’s, a Delaware corporation and a wholly-owned subsidiary of the Company, outstanding 5.375% senior notes due 2026 (together, the "Note Redemptions"), including all premiums, accrued interest and costs and expenses related to the Note Redemptions. Pending the application of the net proceeds of the offering for the foregoing purposes, net proceeds may be temporarily used for general corporate purposes. The foregoing does not constitute a notice of redemption or an obligation to issue a notice of redemption for the outstanding notes of any series.

The Notes will be senior unsecured obligations of the Company and will be equal in right of payment with all of the Company’s existing and future senior indebtedness and will be senior in right of payment to all of the Company’s existing and future subordinated debt. The Notes will not be guaranteed by any of the Company’s subsidiaries.

J.P. Morgan, Barclays, BofA Securities, Truist Securities and Wells Fargo Securities are acting as joint book-running managers for the offering of the Notes.

This offering is being made pursuant to an effective shelf registration statement and prospectus and a related preliminary prospectus supplement filed by the Company with the Securities and Exchange Commission (the "SEC"). Before you invest, you should read the prospectus and the related preliminary prospectus supplement, the registration statement and other documents that Centene has filed with the SEC for more complete information about Centene and this offering.

Copies of the prospectus supplement and related prospectuses for this offering can be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by calling +1 (866) 803-9204; from Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by email at [email protected], or by calling (888) 603-5847; from BofA Securities, Inc., NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department or by email at [email protected]; from Truist Securities by email at [email protected]; and from Wells Fargo Securities, LLC, 550 S. Tryon Street, 5th Floor, Charlotte, North Carolina 28202, Attention: Leveraged Syndicate.

This press release is neither an offer to purchase nor a solicitation of an offer to buy any securities, including the Notes. There shall not be any sale of the securities described herein in any state or other 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 other jurisdiction.

On July 29, 2021 Omega Therapeutics, Inc. (Nasdaq: OMGA) ("Omega"), a development-stage biotechnology company leveraging its OMEGA Epigenomic Programming platform to harness the power of epigenetics to develop a new class of DNA-sequence-targeting, mRNA-encoded programmable epigenetic medicines, reported the pricing of its initial public offering of 7,400,000 shares of its common stock at a price to the public of $17.00 per share (Press release, Omega Therapeutics, JUL 29, 2021, View Source [SID1234585407]). All of the shares of common stock are being offered by Omega. The gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses payable by Omega, are expected to be approximately $125.8 million, excluding any exercise of the underwriters’ option to purchase additional shares. Omega’s common stock is expected to begin trading on the Nasdaq Global Select Market under the ticker symbol "OMGA" on July 30, 2021. The offering is expected to close on August 3, 2021, subject to satisfaction of customary closing conditions. In addition, Omega has granted the underwriters a 30-day option to purchase up to an additional 1,110,000 shares of common stock at the initial public offering price less underwriting discounts and commissions.

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Goldman Sachs & Co. LLC, Jefferies LLC and Piper Sandler are acting as joint book-running managers of the offering. Wedbush PacGrow is acting as lead manager.

A registration statement on Form S-1 (File No. 333-257794) relating to the offering has been filed with the Securities and Exchange Commission and became effective on July 29, 2021. The offering is being made only by means of a prospectus. Copies of the final prospectus relating to the offering may be obtained from: Goldman Sachs & Co. LLC, Attn: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526 or by email at [email protected]; Jefferies LLC, Attn: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by phone at (877) 821-7388, or by email at [email protected]; or Piper Sandler & Co., Attn: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924 or by email at [email protected].

This press release does 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 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 July 29, 2021 MaxCyte, Inc., (LSE: MXCT, MXCN), a leading provider of cell-engineering platform technologies, reported the pricing of its upsized offering of 13,500,000 shares of common stock at an initial offering price of US$13.00 per share (the "Offering") (Press release, MaxCyte, JUL 29, 2021, View Source [SID1234585406]).

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Highlights

Anticipated gross proceeds of approximately US$175,500,000 (or US$201,825,000 if the underwriters exercise their option to purchase additional shares of common stock in full), before deducting underwriting discounts and commissions and estimated offering expenses payable by MaxCyte
MaxCyte intends to use the net proceeds from the Offering for research and development initiatives, to expand its manufacturing capabilities and invest in manufacturing automation, to expand its sales and marketing, business development and field application scientist teams, and for working capital and general corporate purposes
Shares of common stock are expected to commence trading on the Nasdaq Global Select Market ("Nasdaq") on July 30, 2021 under the symbol "MXCT"
MaxCyte has granted the underwriters a 30-day option to purchase up to 2,025,000 additional shares of common stock at the initial offering price per share of common stock less underwriting discounts and commissions.

The closing of the Offering is expected to occur on August 3, 2021, subject to customary closing conditions.

MaxCyte’s common stock will continue to be admitted to trading on the AIM market of the London Stock Exchange (the "AIM") under the symbols "MXCT" and "MXCN." Application is being made for the shares of common stock to be issued at the closing of the Offering to be admitted to trading on AIM under the symbol "MXCT" and it is expected that admission will become effective and dealings in the shares of common stock will commence at 8:00 a.m. (BST) on August 4, 2021.

Cowen, Stifel and William Blair are acting as joint book-running managers for the Offering and as representatives of the underwriters for the Offering. BTIG and Stephens Inc. are also acting as co-managers of the Offering.

A registration statement, including a prospectus, relating to these securities has been filed by MaxCyte and was declared effective by the Securities and Exchange Commission on July 29, 2021. Copies of the registration statement can be accessed through the SEC’s website at www.sec.gov. The Offering is being made only by means of a prospectus. When available, copies of the final prospectus relating to and describing the terms of the Offering may be obtained from the offices of Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, USA, Attn: Prospectus Department, by telephone at +1 (833) 297-2926 or by email at [email protected]; Stifel, Nicolaus & Company, Incorporated, Attention: Prospectus Department, One Montgomery Street, Suite 3700, San Francisco, CA 94104, USA, by telephone at +1 (415) 364-2720 or by email at [email protected]; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, USA, by telephone at +1 (800) 621-0687 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 state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities law of any such state or jurisdiction.

Related party transaction

Casdin Partners Master Fund, L.P. ("Casdin") has indicated an interest in purchasing 1,800,000 shares of common stock at the same price and on the same terms as all other participants in the Offering. Immediately following issuance, Casdin would hold a total of 13,971,334 shares of common stock representing, in aggregate, approximately 14% of MaxCyte’s outstanding shares following closing of the Offering.

The participation by Casdin in the Offering constitutes a related party transaction for the purposes of the AIM Rules for Companies. The independent directors for the purposes of the Offering (being the all of the members of MaxCyte’s board of directors), having consulted with MaxCyte’s nominated adviser, Panmure Gordon, consider that the terms of the related party transaction are fair and reasonable insofar as MaxCyte’s shareholders are concerned.

Amendments to the Bylaws

In connection with the Offering, MaxCyte has adopted amended and restated Bylaws (the "Bylaws"), which will take effect immediately before the closing of the Offering. As before, certain rights have been incorporated into the Bylaws which the Company believes stockholders would expect to see in a company whose shares are admitted to trading on a U.S. listed exchange. A copy of the Bylaws will be publicly filed and made available to both Nasdaq and AIM shareholders upon closing of the Offering.

On July 29, 2021 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global, science-driven biotechnology company, reported positive topline results from an interim analysis of the Phase 3 SEQUOIA trial comparing BRUKINSA (zanubrutinib) to bendamustine and rituximab (B+R) in patients with treatment-naïve (TN) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) whose tumor did not exhibit the deletion of chromosome 17p13.1 (del[17p]) (Press release, BeiGene, JUL 29, 2021, View Source [SID1234585405]).

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"The combined clinical evidence from SEQUOIA, ALPINE1, the 205 trial2, and the AU-003 trial3 validates our confidence in BRUKINSA as a regimen which can offer improvements in treatment outcomes for hundreds of thousands of patients living with CLL"

With a median follow-up of 25.8 months, the SEQUOIA trial met the primary endpoint of progression-free survival (PFS) as assessed by independent review committee (IRC), as BRUKINSA achieved a highly statistically significant improvement in PFS compared to B+R.

In addition, the trial demonstrated a statistically significant improvement in PFS per investigator assessment, a secondary endpoint. BRUKINSA was also generally well-tolerated, consistent with its known safety profile.

"The combined clinical evidence from SEQUOIA, ALPINE1, the 205 trial2, and the AU-003 trial3 validates our confidence in BRUKINSA as a regimen which can offer improvements in treatment outcomes for hundreds of thousands of patients living with CLL," said Jane Huang, M.D., Chief Medical Officer, Hematology at BeiGene. "We are pleased to see that at the interim analysis of the SEQUOIA trial, BRUKINSA significantly prolonged progression-free survival for treatment-naïve CLL patients, and that the demonstrated safety profile was consistent with what we have observed in its global development program with more than 2,300 patients treated with BRUKINSA to date."

1. Results from the interim analysis of ALPINE with a median follow-up time of 15.3 months were reported at the 2021 European Hematology Association (EHA) (Free EHA Whitepaper) (EHA2021) Congress in June 2021. Available at EHA (Free EHA Whitepaper) Open Access Library.
2. Long-term results from BGB-3111-205 with a median follow-up time of 34 months were reported at the EHA (Free EHA Whitepaper)2021 Congress in June 2021. Available at EHA (Free EHA Whitepaper) Open Access Library.
3. Long-term results from BGB-3111-AU-003 in relapsed or refractory CLL with a median follow-up time of 39.4 months were shared at the BeiGene Investor Conference Call in June 2021. Available ir.beigene.com.

About SEQUOIA

SEQUOIA is a randomized, multicenter, global Phase 3 trial (NCT03336333) designed to evaluate the efficacy and safety of BRUKINSA compared to B+R in patients with TN CLL or SLL. The trial consists of three cohorts:

Cohort 1 (n=479): randomized 1:1 to receive BRUKINSA (n=241) or B+R (n=238) until disease progression or unacceptable toxicity, in patients not harboring del(17p); data from this group comprise the primary endpoint;
Cohort 2 (n=110): patients with del(17p) receiving BRUKINSA as a monotherapy; and
Cohort 3 (enrollment ongoing): patients with del(17p) or pathogenic TP53 variant receiving BRUKINSA in combination with venetoclax.
Patients with del(17p) were not randomized to B+R, as they experience poor clinical outcomes and poor response to chemoimmunotherapy. The primary endpoint of the trial is IRC-assessed PFS. Secondary endpoints include investigator-assessed PFS, IRC- and investigator-assessed overall response rate (ORR), overall survival (OS), PFS and ORR in patients with del(17p), and safety.

Cohort 2, representing high-risk patients treated with BRUKINSA monotherapy, was previously presented at the American Society for Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2020. This cohort of patients with del(17p) achieved significant efficacy with an 18-month PFS of 90.6%, as assessed by investigator.

BeiGene plans to consult with global regulatory authorities on next steps and present these data at an upcoming major medical conference.

About Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

Chronic lymphocytic leukemia (CLL) is the most common form of leukemia in adults, with a global incidence of approximately 114,000 new cases in 2017.1,2 CLL affects white blood cells or lymphocytes in the bone marrow.1 Proliferation of cancer cells (leukemia) in the marrow result in reduced ability to fight infection and spread into the blood, which affects other parts of the body including the lymph nodes, liver and spleen.1,3 The BTK pathway is a known route that signals malignant B cells and contributes to the onset of CLL.4 Small lymphocytic lymphoma (SLL) is a non-Hodgkin’s lymphoma affecting the B-lymphocytes of the immune system, which shares many similarities to CLL but with cancer cells found mostly in lymph nodes.5

About BRUKINSA

BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.

BRUKINSA is approved in the following indications and regions:

For the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy (United States, November 2019)*;
For the treatment of MCL in adult patients who have received at least one prior therapy (China, June 2020)**;
For the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adult patients who have received at least one prior therapy (China, June 2020)**;
For the treatment of relapsed or refractory MCL (United Arab Emirates, February 2021);
For the treatment of Waldenström’s macroglobulinemia (WM) in adult patients (Canada, March 2021);
Registered and reimbursed for the treatment of MCL in patients who have received at least one prior therapy (Israel, April 2021);
For the treatment of adult patients with WM who have received at least one prior therapy (China, June 2021)**; and
For the treatment of MCL in adult patients who have received at least one prior therapy (Canada, July 2021).
To date, more than 30 marketing authorization applications in multiple indications have been submitted covering the United States, the European Union, and more than 20 other countries or regions.

* This indication was approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
** This indication was approved under conditional approval. Complete approval for this indication may be contingent upon results from ongoing randomized, controlled confirmatory clinical trials.

BeiGene Oncology

BeiGene is committed to advancing best and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. We have a growing R&D team of approximately 2,300 colleagues dedicated to advancing more than 90 clinical trials involving more than 13,000 patients and healthy volunteers. Our expansive portfolio is directed by a predominantly internalized clinical development team supporting trials in more than 40 countries and regions. Hematology-oncology and solid tumor targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development. We currently market three medicines discovered and developed in our labs: BTK inhibitor BRUKINSA in the United States, China, Canada, and additional international markets; and non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab and PARP inhibitor pamiparib in China.

BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen and Bristol Myers Squibb. We also plan to address greater areas of unmet need globally through our collaborations including with Amgen, Bio-Thera, EUSA Pharma, Mirati Therapeutics, Seagen, and Zymeworks. BeiGene has also entered into a collaboration with Novartis Pharma AG granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.

On July 29, 2021 Lantheus Holdings, Inc. (NASDAQ: LNTH) (Lantheus) reported that its subsidiary, EXINI Diagnostics AB, was granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its digital application, aPROMISE (automated PROstate Cancer Molecular Imaging Standardized Evaluation) (Press release, Lantheus Medical Imaging, JUL 29, 2021, View Source [SID1234585404]). Clinicians will have the option to utilize aPROMISE with PYLARIFY (piflufolastat F 18) to increase the efficiency and reproducibility of their PSMA PET/CT assessments. PYLARIFY was recently approved by the FDA and is the first and only commercially available PSMA-targeted PET imaging agent for prostate cancer.

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aPROMISE is an artificial intelligence-based, medical device software that uses a deep learning algorithm trained and validated across over 3,000 PSMA images to date, to allow healthcare professionals and researchers to perform quantitative assessment of PSMA PET/CT images in prostate cancer. The PROMISE criteria were developed by leading experts in prostate cancer imaging to standardize quantitative evaluation of prostate cancer lesions by location using prostate-specific membrane antigen (PSMA) PET/CT.1 aPROMISE facilitates rapid and robust quantification of prostate cancer lesions in anatomical context, enabling clinicians to make routine use in the clinic of a comprehensive, automated approach to patient evaluation. aPROMISE includes a solution for automated body segmentation and marking, quantifying and reporting suspicious lesions in their anatomical context. aPROMISE provides enhanced consistency in quantitative analysis and standardized reports and has demonstrated increased efficiency and reproducibility of clinicians’ PSMA PET/CT image assessments.2,3

"Lantheus is pleased with the FDA clearance of aPROMISE, our AI-enabled digital application that expands our PSMA platform," said Etienne Montagut, Chief Business Officer for Lantheus. "We are excited to provide such an innovative tool for PSMA quantification and reporting that can empower clinicians to make more informed treatment decisions for their prostate cancer patients."

aPROMISE Indications for Use

aPROMISE is intended to be used by healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images. The system is intended to be used with images acquired using nuclear medicine (NM) imaging using PSMA PET/CT. The device provides general Picture Archiving and Communications System (PACS) tools as well as a clinical application for oncology including marking of regions of interest and quantitative analysis.

About Prostate Cancer

Prostate cancer is the second most common form of cancer affecting men in the United States — an estimated one in eight men will be diagnosed with prostate cancer in their lifetimes. The American Cancer Society estimates that in 2021, almost 250,000 new cases of prostate cancer will be diagnosed, and more than 30,000 men will die of the disease. Approximately 3.1 million men in the United States currently count themselves as prostate cancer survivors.4

About PYLARIFY (piflufolastat F 18) Injection

PYLARIFY (piflufolastat F 18) injection (also known as 18F-DCFPyL or PyL) is a fluorinated small molecule PSMA-targeted PET imaging agent that enables visualization of lymph nodes, bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer. For men with prostate cancer, PYLARIFY PET combines the accuracy of PET imaging, the precision of PSMA targeting and the clarity of an F 18 radioisotope5 for superior diagnostic performance. The recommended PYLARIFY dose is 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi), administered as a bolus intravenous injection.6-10

PYLARIFY (piflufolastat F 18) Injection

Indication

PYLARIFY (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

with suspected metastasis who are candidates for initial definitive therapy.
with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
Important Safety Information
Contraindications

None.

Warnings and Precautions

Risk of Image Misinterpretation

Imaging interpretation errors can occur with PYLARIFY imaging. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of PYLARIFY for imaging of patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. The performance of PYLARIFY for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by risk factors such as Gleason score and tumor stage. PYLARIFY uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes and in normal tissues. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

Hypersensitivity Reactions

Monitor patients for hypersensitivity reactions, particularly patients with a history of allergy to other drugs and foods. Reactions may be delayed. Always have trained staff and resuscitation equipment available.

Radiation Risks

Diagnostic radiopharmaceuticals, including PYLARIFY, expose patients to radiation. Radiation exposure is associated with a dose-dependent increased risk of cancer. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration.

Adverse Reactions

The most frequently reported adverse reactions were headaches, dysgeusia and fatigue, occurring at rate of ≤2% during clinical studies with PYLARIFY. In addition, a delayed hypersensitivity reaction was reported in one patient (0.2%) with a history of allergic reactions.

Drug interactions

Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of PYLARIFY in prostate cancer. The effect of these therapies on performance of PYLARIFY PET has not been established.

To report suspected adverse reactions for PYLARIFY, call 1-800-362-2668 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For important risk and use information about PYLARIFY Injection, please see Full Prescribing information.