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Evogene to Present at Jefferies Virtual Industrials Conference, 2021

On July 29, 2021 Evogene Ltd. (NASDAQ: EVGN) (TASE: EVGN), a leading computational biology company aiming to revolutionize life-science product development across several market segments, reported that Ofer Haviv, Evogene’s President and CEO, will present at the Jefferies Virtual Industrials Conference, 2021 taking place on August 3-4,2021 (Press release, Evogene, JUL 29, 2021, View Source [SID1234585416]). Mr. Haviv’s presentation will focus on Evogene’s disruptive technologies; its tailor-made engines for product discovery and development and its fields of activity through its main subsidiaries and will take place on Tuesday, August 3, 2021, at 09:00 am, EST.

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Investors attending the conference who wish to meet with Mr. Haviv, may contact Evogene’s Investor Relations team at [email protected] or through the conference’s online meeting platform.

Blueprint Medicines Reports Second Quarter 2021 Financial Results

On July 29, 2021 Blueprint Medicines Corporation (NASDAQ:BPMC) reported financial results and provided a business update for the second quarter ended June 30, 2021 (Press release, Blueprint Medicines, JUL 29, 2021, View Source [SID1234585415]).

"In the second quarter, we achieved one of our foundational corporate goals, securing U.S. approval of AYVAKIT for advanced systemic mastocytosis, and the launch of this therapy is off to a great start with broad prescriber demand," said Jeff Albers, Chief Executive Officer of Blueprint Medicines. "In addition, we continued to progress our expanding clinical portfolio with the initiation of the Phase 1/2 trial of BLU-945, the initiation of the Phase 2/3 HARBOR trial of BLU-263 and the announcement of a strategic research collaboration with MD Anderson to accelerate the development of BLU-222, all of which exemplify the potential impact of our next wave of therapeutic candidates. This commercial and clinical progress, combined with our financial strength, provides a robust foundation for future growth as we look to address the needs of many more patients with cancer and hematologic disorders."

Second Quarter 2021 Highlights and Recent Progress

AYVAKIT/AYVAKYT (avapritinib): systemic mastocytosis (SM) and gastrointestinal stromal tumor (GIST)

Recorded $8.5 million in net product revenue during the second quarter of 2021 for AYVAKIT/AYVAKYT, which was approved by the U.S. Food and Drug Administration (FDA) in June 2021 for the treatment of adult patients with advanced systemic mastocytosis (Advanced SM), including aggressive SM (ASM), SM with an associated hematologic neoplasm (SM-AHN) and mast cell leukemia (MCL). Read the press release announcing the expansion of the FDA label for AYVAKIT into advanced SM here. AYVAKIT received its initial approval from the FDA in 2020 for the treatment of adults with unresectable or metastatic GIST harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations. Please click here to see the full Prescribing Information for AYVAKIT and visit www.AYVAKIT.com for more information on AYVAKIT.
GAVRETO (pralsetinib): RET-altered cancers

Recorded $2.9 million in net product revenue during the second quarter of 2021 for GAVRETO, which was approved by the FDA in September 2020 for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test and in December 2020 for the treatment of patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancer. Blueprint Medicines is commercializing GAVRETO in the U.S. together with Genentech, Inc., a member of the Roche Group. Please click here to see the full Prescribing Information for GAVRETO and visit www.GAVRETO.com for more information on GAVRETO.
Reported updated data from the Phase 1/2 ARROW clinical trial of GAVRETO in metastatic RET fusion-positive NSCLC and other advanced solid tumors at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The data showed high response rates to GAVRETO in treatment-naïve patients with RET fusion-positive NSCLC, clinical activity across a number of RET fusion-positive tumor types and a safety profile consistent with previously reported results. Read the press release here.
BLU-263: SM

Initiated the HARBOR trial, a randomized, double-blind, placebo-controlled Phase 2/3 trial in non-advanced SM.
BLU-945: treatment-resistant EGFR-driven NSCLC

Initiated the global Phase 1/2 trial of BLU-945 in patients with treatment-resistant EGFR-driven NSCLC.
BLU-222: Cyclin E-aberrant cancers

Announced a strategic research collaboration with The University of Texas MD Anderson Cancer Center focused on accelerating development of BLU-222, an investigational precision therapy designed to target cyclin-dependent kinase 2 (CDK2). Read the press release here.
Corporate:

Announced the appointment of Percy Carter, MBA, Ph.D., as Chief Scientific Officer. In this role, Dr. Carter oversees all research and preclinical development. Read the press release here.
Key Upcoming Milestones

The company expects to achieve the following near-term milestones:

Present preclinical data supporting combination of BLU-945 and BLU-701 in treatment-naïve EGFR-driven NSCLC in the second half of 2021.
Initiate a Phase 1 trial of BLU-701 in patients with treatment-resistant EGFR-driven NSCLC in the second half of 2021.
Initiate a Phase 1 trial of BLU-222, a CDK2 inhibitor targeting cyclin-E aberrant cancers, in the first half of 2022.
Disclose topline data for the registration-enabling Part 2 of the PIONEER trial of AYVAKIT in non-advanced systemic mastocytosis in mid-2022.
Second Quarter 2021 Financial Results

Revenues: Revenues were $27.3 million for the second quarter of 2021, including $8.5 million of net product revenues from sales of AYVAKIT/AYVAKYT, $2.9 million of net product sales from GAVRETO and $15.9 million in collaboration revenues. Blueprint recorded revenues of $8.3 million in the second quarter of 2020, including $5.7 million of net product revenues from sales of AYVAKIT and $2.7 million in collaboration revenues. The increase in net product revenues was driven by increased sales quantity and the increase in collaboration revenues was primarily driven by the sales of drug substance and drug product to our collaboration partners.
Cost of Sales: Cost of sales was $6.5 million for the second quarter of 2021, as compared to $0.1 million for the second quarter of 2020. Cost of sales includes manufacturing costs associated with our products sales as well as costs associated with the sale of drug product to our collaboration partners. The increase in costs of product sales was primarily driven by the lower margin product sales to our collaboration partners during the second quarter of 2021.
R&D Expenses: Research and development expenses were $80.0 million for the second quarter of 2021, as compared to $91.1 million for the second quarter of 2020. This decrease was primarily due to decreased expenses associated with clinical supply manufacturing activities and reimbursement from the global development cost sharing arrangement under our collaboration with Roche for pralsetinib, partially offset by increased costs related to early discovery activities. Research and development expenses included $10.5 million in stock-based compensation expenses for the second quarter of 2021.
SG&A Expenses: Selling, general and administrative expenses were $49.3 million for the second quarter of 2021, as compared to $42.2 million for the second quarter of 2020. This increase was primarily due to increased costs associated with building our commercial infrastructure for commercialization of AYVAKIT/AYVAKYT and GAVRETO, partially offset by reimbursement under our collaboration with Roche for pralsetinib. General and administrative expenses included $13.8 million in stock-based compensation expenses for the second quarter of 2021.
Net Loss: Net loss was $108.4 million for the second quarter of 2021, or a net loss per share of $1.86, as compared to a net loss of $123.5 million for the second quarter of 2020, or a net loss per share of $2.28.
Cash Position: As of June 30, 2021, cash, cash equivalents and investments were $1,380.1 million, as compared to $1,549.7 million as of December 31, 2020.
Conference Call Information

Blueprint Medicines will host a live conference call and webcast at 8:30 a.m. ET today to discuss second quarter 2021 financial results and recent business activities. The conference call may be accessed by dialing 844-200-6205 (domestic) or +44-208-0682-558 (international) and referring to conference ID 619159. A webcast of the call will be available under "Events and Presentations" in the Investors & Media section of the Blueprint Medicines website at View Source The archived webcast will be available on Blueprint Medicines’ website approximately two hours after the conference call and will be available for 30 days following the call.

Upcoming Investor Conference

Blueprint Medicines will participate in the 2021 Wedbush Pacgrow Healthcare Virtual Conference on Tuesday, August 10, 2021. Christina Rossi, Chief Commercial Officer, will participate in a panel discussion, "Building Back a Better Commercial Infrastructure – Selling in COVID Times," beginning at 8:35 a.m. ET. A live webcast of the panel discussion will be available by visiting the Investors & Media section of Blueprint Medicines’ website at View Source A replay of the webcast will be archived on Blueprint Medicines’ website for 30 days following the presentation.

Centene Corporation Announces Offering of Senior Notes

On July 29, 2021 Centene Corporation (NYSE: CNC) ("Centene" or the "Company") reported that it has commenced an underwritten public offering to sell $1,800,000,000 of senior notes (Press release, Centene , JUL 29, 2021, View Source [SID1234585414]). The $1,800,000,000 offering of senior notes will include an add-on to its 2.450% senior notes due 2028 (the "2028 Notes") and new senior notes due 2031 (together with the 2028 Notes, the "Notes"), subject to market and other conditions. The 2028 Notes will constitute a further issuance of the $1,800,000,000 aggregate principal amount of 2.450% senior notes due 2028 that were issued on July 1, 2021 and will have the same terms as such notes, other than the issue date and the issue price.

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.

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.

Cytocom, Inc. Receives Commitments for $90 Million in Equity and Debt Financing

On July 29, 2021 Cytocom, Inc., (NASDAQ: CBLI), a leading biopharmaceutical company developing next generation therapies that focus on immune homeostasis, reported that it has secured agreements for $90 million in committed capital (Press release, Cytocom, JUL 29, 2021, https://www.prnewswire.com/news-releases/cytocom-inc-receives-commitments-for-90-million-in-equity-and-debt-financing-301343878.html [SID1234585413]). The financing is led by a $75 million equity commitment from GEM Global Yield LLC SCS in the form of a Share Subscription Facility. Cytocom intends to draw down the first $15 million within 30 days of the closing of the recently completed merger between Cleveland BioLabs and Cytocom. A combination of debt and equity financing from Avenue Capital and Adit Ventures, totaling $17 million, will also be made available on a draw schedule. Cytocom will use the proceeds to fund operations, advance growth initiatives, and further clinical development of the company’s internal pipeline. Bridgeway Capital Partners and its affiliates served as the exclusive financial advisor and placement agent on the transaction with Covington & Burling LLP providing legal counsel.

With access to $90 million in operating capital, subject to customary closing conditions for each draw, Cytocom will continue development of an internal pipeline that includes the company’s platform of toll-like immune receptors. Cytocom’s current clinical programs for COVID-19, Crohn’s Disease, pancreatic cancer and a growing portfolio of immune-modulating therapies under development using Cytocom’s proprietary technology platform are designed to rebalance the body’s immune system and restore homeostasis.

"Having now completed the merger between Cleveland BioLabs and Cytocom, this financing is an essential component to our growth strategy as a public company and should ensure that we have access to capital to continue advancing a cutting-edge clinical pipeline of immune-modulating therapies," stated Michael K. Handley, President and CEO of Cytocom. "Our goal as a company is to become a recognized leader in immune-modulating treatments targeting emerging viruses, including COVID-19, cancer, inflammation and autoimmune diseases. The successful merger, coupled with the acquisition of ImQuest Life Sciences and the previously announced Nasdaq listing, should set the stage for multiple catalysts that we believe will serve to showcase the power of our drug development technologies, generate shareholder value, and raise our visibility within the investor community."

"Avenue Capital is pleased to make this investment as we believe Cytocom could play an important role in developing the next generation of immune-modulating therapies," said Chad Norman, Senior Portfolio Manager for Avenue Venture Opportunities Fund. "There are few companies in the immunology space with such an advanced and differentiated pipeline as Cytocom. Furthermore, we believe the successful merger between Cleveland BioLabs and Cytocom and the acquisition of ImQuest Life Sciences will position the combined company for substantial growth in the years to come."

I-Mab Announces Authorization of a Renewed Stock Repurchase Program by the Company up to US$40 Million

On July 29, 2021 I-Mab (the "Company") (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, reported that its Board of Directors (the "Board") has authorized a new stock repurchase program. With the Board’s authorization, the Company may repurchase up to US$40 million of its ordinary shares in the form of American depositary shares ("ADS") over the next 12 months (Press release, I-Mab Biopharma, JUL 29, 2021, View Source [SID1234585412]).

In July 2020, the Board first authorized a stock repurchase program under which the Company may repurchase up to US$20 million of its ordinary shares in the form of ADS over a 12-month period. The renewed stock repurchase program now has an increased cap of US$40 million.

"We are pleased that the Board has authorized this new stock repurchase program by the Company." said Dr. Jingwu Zang, Founder and Chairman of I-Mab, "The Company’s fundamentals remain very strong and the authorization demonstrates the confidence we have in our globally competitive innovative pipeline and our journey to becoming a fully integrated global biopharma."

Repurchases, if any, under the program will be made at the discretion of management, and will depend upon market pricing and conditions, business, legal, accounting and other considerations. Any such share purchases will be made by the Company from time to time in open market transactions, or otherwise in compliance with Rule 10b-18 under the Securities Exchange Act of 1934, or pursuant to a trading plan adopted in accordance with Rule 10b5–1 of the Securities Exchange Act of 1934.

The repurchase program is effective upon and from the date on which a formal stock repurchase plan engagement agreement is signed with a qualified broker-dealer(s), and terminates over a twelve-month period depending upon market and economic conditions, and other factors including price, legal and regulatory requirements and capital availability. The program does not obligate I-Mab to acquire any particular number of its ADSs, and the program may be modified or suspended at any time at the management’s discretion.