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Sorrento Announces Clinical Research Agreement With Mayo Clinic and FDA Clearance for the First Phase 1b Pilot Study Using Sofusa Lymphatic Drug Delivery Technology to Deliver Ipilimumab in Patients With Melanoma

SAN DIEGO, June 11, 2021 (GLOBE NEWSWIRE) — Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) today announced a research collaboration agreement with Mayo Clinic to conduct human clinical proof of concept studies using the Sofusa Lymphatic Drug Delivery System (S-LDDS) technology across multiple products and indications. Sofusa is a drug delivery platform which delivers biologic therapies through the skin and directly into the lymphatic system with potential to improve the efficacy and safety of immuno-oncology therapies. Targeting delivery to the lymphatics should also enable reduced dosing as compared to traditional systemic infusions or subcutaneous injections.

The first study resulting in this agreement is MC20711, a Phase 1b study of the administration of Ipilimumab Intra-Lymphatically using the Sofusa® DoseConnect™ in Patients with Metastatic Melanoma. This is an investigator-initiated study developed by Svetomir Markovic, MD, PhD, and his team. “Checkpoint therapies have shown good results in some patients; however, response rates are still low, and this may be due to poor exposure to drug targets which reside in lymph nodes. By delivering checkpoint therapies directly to the lymphatics, we expect to see an increase in clinical response and potentially a decrease in systemic side effects” – Mike Royal, MD, CMO for Sorrento Therapeutics.

This agreement builds upon the previously announced exclusive licensing agreement where Sorrento licensed Mayo Clinic’s proprietary Antibody-Drug-Nanoparticle albumin-bound Immune Complex platform technology. “Both of these agreements are part of our strategic focus to combine potent antibodies from our G-MAB library with next-generation therapeutic platform technologies to deliver unparalleled safety and efficacy” – Henry Ji, President and CEO, Sorrento Therapeutics.

Mayo Clinic, Dr. Svetomir Markovic and Dr. James Jakub have financial interests in the technology referenced in this release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education, and research.

About Sorrento Therapeutics, Inc. 

Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to treat cancers and COVID-19. Sorrento’s multimodal, multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies (“G-MAB™ library”), clinical stage immuno-cellular therapies (“CAR-T”, “DAR-T™”), antibody-drug conjugates (“ADC”), and clinical stage oncolytic virus (“Seprehvir™”).  Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including COVIGUARD™, COVI-AMG™, COVISHIELD™, Gene-MAb™, COVI-MSC™ and COVIDROPS™; and diagnostic test solutions, including COVITRACK™, COVISTIX™ and COVITRACE™.

Sorrento’s commitment to life-enhancing therapies for patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule, resiniferatoxin (“RTX”), and SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (SEMDEXA™), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, and to commercialize ZTlido® (lidocaine topical system) 1.8% for the treatment of post-herpetic neuralgia. RTX has completed a Phase IB trial for intractable pain associated with cancer and a Phase 1B trial in osteoarthritis patients. SEMDEXA is in a pivotal Phase 3 trial for the treatment of lumbosacral radicular pain, or sciatica. ZTlido® was approved by the FDA on February 28, 2018.

For more information visit www.sorrentotherapeutics.com

Forward-Looking Statements

This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sorrento Therapeutics, Inc., under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding the safety and potential efficacy of the Sofusa Lymphatic Delivery System, including for the treatment of Rheumatoid Arthritis; the ability of the Sofusa Lymphatic Delivery System to reduce required dosing of a drug; the potential for the Sofusa Lymphatic Delivery System to improve safety and efficacy and to reduce required dosing as compared to traditional systemic or subcutaneous injections or infusions; the clinical testing of a SOFUSA product candidate; the preliminary results of the first patient in the Phase 1b study to date; the continued enrollment and potential commencement of future clinical trials for a SOFUSA product candidate; the potential for pre-clinical study results to be replicated or continue to show improved clinical safety or efficacy in the current clinical trial and future clinical trials; the potential for preliminary data results to be replicated or continue to show improved clinical safety or efficacy as the ongoing trial continues; the potential for the Phase 1b study to provide data regarding lymphatic pumping rates as an exploratory endpoint; the potential for delivery of biologic drugs directly into the lymphatic system to improve lymphatic function and provide direct and sustained exposure to therapeutic targets; and Sorento’s potential position in the therapeutics industry.

Risks and uncertainties that could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: risks related to Sorrento’s and its subsidiaries’, affiliates’ and partners’ technologies and prospects and collaborations with partners, including, but not limited to risks related to conducting clinical studies and seeking regulatory approval for the Sofusa Lymphatic Drug Delivery Device; conducting and receiving results of clinical trials; clinical development risks, including risks in the progress, timing, cost, and results of clinical trials and product development programs; risk of difficulties or delays in obtaining regulatory approvals; risks that clinical study results may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval; risks that prior test, study and trial results may not be replicated in future studies and trials; risks of manufacturing and supplying drug product; risks related to leveraging the expertise of its employees, subsidiaries, affiliates and partners to assist Sorrento in the execution of its therapeutic product candidates strategies; risks related to the global impact of COVID-19; and other risks that are described in Sorrento’s most recent periodic reports filed with the Securities and Exchange Commission, including Sorrento’s Annual Report on Form 10-K for the year ended December 31, 2020, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release except as required by law.


Contact


Alexis Nahama, DVM (SVP Corporate Development)
Email: [email protected]

Sorrento® and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc.

G-MAB™, DAR-T™, SOFUSA®, COVIGUARD™, COVI-AMG™, COVISHIELD™, Gene-MAb™, COVIDROPS™, COVI-MSC™, COVITRACK™, COVITRACE™ and COVISTIX™ are trademarks of Sorrento Therapeutics, Inc.

SEMDEXA™ is a trademark of Semnur Pharmaceuticals, Inc.

ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc.

All other trademarks are the property of their respective owners.

©2021 Sorrento Therapeutics, Inc. All Rights Reserved.



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Brit + Co Launches Selfmade Season Four in Collaboration with Office Depot

Brit + Co Launches Selfmade Season Four in Collaboration with Office Depot

Virtual Startup School That Has Helped Female Entrepreneurs Launch Hundreds of Mission-Driven Companies Kicks Off Summer Session on Monday, June 28

SAN FRANCISCO & BOCA RATON, Fla.–(BUSINESS WIRE)–
Brit + Co and Office Depot today announced that Office Depot will continue to provide opportunities for female entrepreneurs with the company’s sponsorship of the fourth cohort of Selfmade,Brit + Co’s 10-week virtual startup school for women. The course is hosted by Brit + Co founder Brit Morin, with over a dozen other notable female founders, experts and investors signed on to help teach, including Katrina Lake (founder and CEO of Stich Fix), Toni Ko (founder of NYX), and Arlan Hamilton (founder and managing partner of Backstage Capital) and includes highly personalized skill development to enable each student to start or grow her own business.

To help drive educational change, Office Depot’s sponsorship will enable the course to be made free for up to 200 women, focusing on women of color, women from underserved and underrepresented communities, and women in need of support to help them trailblaze.

The spring Selfmade session saw a number of mission-driven companies, with 17.7% of the students’ brands dedicated to women’s empowerment, 10.2% focused on mental health-related issues, and 5% addressing environmental issues.

“We’re happy to continue our collaboration with Brit + Co to help provide women an opportunity to turn their passion projects into businesses and take their existing businesses to new heights,” said Wesley Brinkhurst, vice president of marketing for Office Depot. “We’re so inspired by the participants’ desires to change their own lives, as well as the lives of others, and encourage female entrepreneurs to register for the next Selfmade program session to help make their dreams a reality.”

“The women of the last cohort were incredibly dedicated to facilitating positive change, founding and growing companies that are both improving the world and improving their lives–from helping to treat mental health, to making the world safer for women, to supporting working moms,” said Morin. “After the difficulty of the past year and a half, they still took a leap of faith and signed up for Selfmade, and with the support of our group and one-on-one coaching, inspiration and advice from our guest teachers, they have hustled their way to finding their passions, launching companies, and earning revenue. I have been so impressed by the drive and ambition of our alumni.”

Office Depot-sponsored student Jhanelle Elissa founded Jiive, a new type of events platform for real-life community & live experiences born out of the isolation she felt during the pandemic as someone living on her own. She recognized that others were also struggling with their mental health during this challenging time, and Jiive was born out of this, as a way to connect people through live events.

“My hope in signing up for this course was to gain a sense of community with fellow entrepreneurs who were also in the early stages of founding their companies and also to learn about new funding resources to explore,” said Elissa. “The ladies running Selfmade were not only so generous with their time and supportive, but also transparent and provided a realistic view of the entrepreneurship journey. I’m excited to continue building my company and bringing these newfound connections and relationships into this next phase of getting my ‘big vision venture’ off the ground.”

Features and benefits of Selfmade include:

  • 15+ hours of live instruction in all facets of how to start a company
  • 1:1 coaching and group chats with like-minded entrepreneurs
  • Customizable templates for financial statement presentations, proposal decks, marketing assets and more
  • Access to world class experts in tech, finance, marketing, sales, and investing

Selfmade registration is currently open and class will kick off on Monday, June 28. For more information on Selfmade visit, TrySelfmade.com and click here to hear from past program participants.

About Brit + Co

Founded by Brit Morin, Brit + Co is on a mission to give women the courage and creativity to live life at their fullest potential. Through our inspirational content, educational online classes and useful products, she is enabled to shape her future. Over the past nine years, Brit + Co has become one of the largest digital brands for women, now reaching an engaged community of over 115 million monthly users across its website and platforms. It is a top 5 global publisher on Pinterest, has garnered over a billion video views and has produced more than 60,000 pieces of content. The brand extends offline as well, with permanent retail experiences, classes, events, and physical products sold at mass retail stores nationwide. Visit Brit.co for more information.

About Office Depot

Office Depot, LLC is a wholly owned subsidiary of The ODP Corporation (NASDAQ:ODP), a leading provider of business services and supplies, products and digital workplace technology solutions to small, medium and enterprise businesses, through an integrated business-to-business (B2B) distribution platform, which includes world-class supply chain and distribution operations, dedicated sales professionals and technicians, online presence, and approximately 1,100 stores. Through its banner brands Office Depot® and OfficeMax®, as well as others, the company offers its customers the tools and resources they need to focus on their passion of starting, growing and running their business. For more information, visit news.theodpcorp.com and follow @officedepot on Facebook, Twitter and Instagram.

The ODP Corporation and Office Depot are trademarks of The Office Club, Inc. OfficeMax is a trademark of OMX, Inc. CompuCom is a trademark of CompuCom Systems, Inc. Grand&Toy is a trademark of Grand & Toy, LLC in Canada. ©2021 Office Depot, LLC. All rights reserved. Any other product or company names mentioned herein are the trademarks of their respective owners.

Julia Allison

Brit + Co

[email protected]

Danny Jovic

Office Depot

[email protected]

KEYWORDS: United States North America California Florida

INDUSTRY KEYWORDS: Consulting Office Products Education Professional Services Philanthropy Women Small Business Other Philanthropy Training Retail Consumer

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Northern Trust Appoints Managing Director in New York

Northern Trust Appoints Managing Director in New York

Tom Dempsey brings deep experience in the private equity space specifically within the financial services industry

NEW YORK–(BUSINESS WIRE)–
Northern Trust has appointed Thomas F. Dempsey as Managing Director responsible for growing and deepening relationships with principals in the private equity and hedge fund segments, as well as working with ultra-high net worth families and the advisors who serve them. Dempsey’s primary focus will be on connecting Northern Trust with firms and their principals, and introducing new relationships to the breadth of investment management and advisory resources available at Northern Trust. Dempsey will work closely with Northern Trust’s Global Family Office (GFO) team of professionals for relationships with family offices and private investment companies.

“The needs of our clients are ever evolving,” said Henry P. Johnson, President of Northern Trust Wealth Management in the Eastern U.S. “Tom is a trusted advisor, highly-skilled director, and proven leader. His addition reinforces our firm’s commitment to serving the robust and growing entrepreneurial community, particularly in the alternative investment space, and bolsters the vast capabilities of our team. Tom’s commitment to cultivating authentic relationships grounded in advice and integrity aligns perfectly with Northern Trust’s advice-based approach. We are pleased to have him take this role and bring his expertise and innovative approach to our business.”

Dempsey has extensive experience in business development and strategy at several companies in the financial services industry. In his most recent position, he was a partner at Corsair Capital in New York. There, he was responsible for global investor relations, fundraising and marketing. He has also worked at Fulcrum Asset Management, Tremblant Capital Group, and Goldman Sachs Asset Management. Tom began his financial services career at Fiduciary Trust Company International. Dempsey possesses a B.A. from Georgetown University where he currently serves as a Member of their Board of Regents. He is also a member of the Investment Committee at Sacred Heart Greenwich.

“Northern Trust shares my passion for delivering personalized advice to help drive successful results not only for businesses and their investors, but also the individuals and families behind those companies,” said Dempsey. “I am excited to join the team of a firm with such a strong legacy of acting in the best interest of clients, as well as an entrepreneurial spirit and culture that promotes innovation.”

Northern Trust Wealth Management offers holistic wealth management services for affluent individuals and families, family offices, foundations and endowments, and privately held businesses. It is recognized for its innovative technology, service excellence and depth of expertise and ranks among the top 10 U.S. wealth managers, with $355.4 billion in assets under management as of March 31, 2021. The Northern Trust Company is an Equal Housing Lender. Member FDIC.

About Northern Trust

Northern Trust Corporation (Nasdaq: NTRS) is a leading provider of wealth management, asset servicing, asset management and banking to corporations, institutions, affluent families and individuals. Founded in Chicago in 1889, Northern Trust has a global presence with offices in 22 U.S. states and Washington, D.C., and across 22 locations in Canada, Europe, the Middle East and the Asia-Pacific region. As of March 31, 2021, Northern Trust had assets under custody/administration of $14.8 trillion, and assets under management of $1.4 trillion. For more than 130 years, Northern Trust has earned distinction as an industry leader for exceptional service, financial expertise, integrity and innovation. Please visit our website or follow us on Twitter.

Northern Trust Corporation, Head Office: 50 South La Salle Street, Chicago, Illinois 60603 U.S.A., incorporated with limited liability in the U.S. Please read our global and regulatory information.

Media Contact:

Doug Holt

312-557-1571

[email protected]

http://www.northerntrust.com

KEYWORDS: United States North America New York

INDUSTRY KEYWORDS: Banking Professional Services Finance

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Constellation Pharmaceuticals Provides an Update from the Ongoing MANIFEST Study of Pelabresib

  • Translational data support the disease-modifying potential of pelabresib
  • Central pathology review confirmed bone marrow fibrosis improvements observed with pelabresib treatment
  • Impact of pelabresib treatment observed across a wide range of myelofibrosis patient subgroups

CAMBRIDGE, Mass., June 11, 2021 (GLOBE NEWSWIRE) — Constellation Pharmaceuticals, Inc. (Nasdaq: CNST), a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, today announced that three posters relating to the MANIFEST clinical trial of pelabresib (CPI-0610) in myelofibrosis (MF) were published online in association with the European Hematology Association (EHA) annual meeting. The data in these posters are based on a data cutoff of September 29, 2020 from the MANIFEST Phase 2 clinical trial and reflect an analysis of pelabresib clinical and translational activity.  

“We are particularly enthusiastic about the publication of centrally reviewed translational data, which describe early improvements in bone marrow fibrosis in patients treated with pelabresib, and we believe these results support our thesis of disease-modifying treatment effects that go beyond symptom management,” said Patrick Trojer, chief scientific officer of Constellation Pharmaceuticals. “We are currently enrolling patients in the Phase 3 pivotal study of MANIFEST-2 and our goal is to transform the standard of care for the treatment of myelofibrosis.”

Data Highlights


Translational data, across all three arms of the Phase 2 MANIFEST study, support the disease-modifying potential of pelabresib

  • Centrally reviewed bone marrow fibrosis (BMF) pathology conducted in 63 patients showed similar improvements as reported previously for local review of BMF grade. 23 out of 63 patients (37%) achieved at least a 1 grade improvement in BMF. Of these patients, 83% achieved improvements in BMF by 24 weeks.
  • 17% of the patients with BMF improvement (4 out of 23), improved by at least 2 grades.
  • 31 out of 63 patients (49%) were stabilized or had no change, and only 4 out of 63 patients (6%) worsened.
  • An increase in BM erythroid progenitor cells and reduction of the number and cluster formation of megakaryocytes in the BM was observed in 59% and 65%, respectively, of 37 samples from patients treated with pelabresib either as a monotherapy or in combination with ruxolitinib.
  • Pelabresib durably reduced inflammatory cytokines such as tumor necrosis factor alpha (TNF alpha) and interleukin 18 (IL18) as early as 2 weeks and maintained through 24 weeks of treatment, based on an analysis of patient samples.


Arm 3 (1L) – CPI-0610 + ruxolitinib interim efficacy subgroup analysis in JAK-inhibitor-naïve patients

  • As previously reported at ASH 2020, 42 of 63 evaluable patients (67%) achieved a ≥35% reduction in spleen volume (SVR35) at 24 weeks (the primary endpoint for Arm 3). 34 of 60 evaluable patients (57%) achieved a ≥50% reduction in Total Symptom Scores (TSS50) at 24 weeks.
  • Strong response was observed with pelabresib, irrespective of baseline risk status or demographic and disease characteristics.
  • Central pathology review of 27 1L patient bone marrow samples showed at least a one-grade improvement in bone marrow fibrosis in 9 out of 27 patients (33%); in all of these patients, improvement was observed within 6 months of starting treatment. 16 out of 27 patients (59%) showed stabilization of bone marrow fibrosis, while only 1 out of 27 patients (4%) showed worsening.


Arm 1 and 2 (2L) – Interim analysis demonstrating that pelabresib monotherapy in JAK-inhibitor-experienced or -ineligible patients, and with pelabresib + ruxolitinib in ruxolitinib-experienced patients, resulted in improvements in anemia

  • As previously reported at ASH 2020, 3 of 14 evaluable Transfusion Dependent (TD) patients (21%) in Arm 1A achieved transfusion independence (the primary endpoint for arms 1A and 2A) and 13 of 36 evaluable TD patients (36%) in Arm 2A achieved transfusion independence.  
  • 9 out of 15 evaluable TD patients (60%) in Arm 1A, and 25 out of 47 of evaluable TD patients (53%) in Arm 2A achieved a ≥50% reduction in red blood cell transfusions.

Safety

As of the September 29, 2020 data cutoff, pelabresib was generally well tolerated in MANIFEST, both as monotherapy and in combination with ruxolitinib, and in both JAK-inhibitor-naïve and -ineligible as well as JAK-inhibitor-experienced patients.

Among the most common treatment-emergent adverse events (TEAEs) for CPI-0610 monotherapy in 46 safety-evaluable patients in Arm 1, those that were Grade 3 were thrombocytopenia (15%), anemia (13%), diarrhea (4%), constipation (2%), respiratory tract infection (2%), and weight decrease (2%). Amongst the most common TEAEs, there were no Grade 4. Other Grade 3/4 TEAEs (≥5%) include hyperuricemia (9%), hyperkalemia (7%) and dyspnea (7%). Nine patients discontinued treatment because of TEAEs. No Grade 5 events were observed.

Among the most common TEAEs in 78 safety-evaluable patients in Arm 2, those that were Grade 3 were thrombocytopenia (23%), anemia (10%), respiratory tract infections (5%), diarrhea (4%), asthenic conditions (4%), and nausea (3%). Amongst the most common TEAEs, Grade 4 events included thrombocytopenia (3%) and anemia (1%). Nine patients discontinued treatment due to TEAEs, including six Grade 5 TEAEs, which were acute kidney injury, traumatic subdural hematoma, brain stem hemorrhage (no concomitant thrombocytopenia), disease progression, congestive heart failure, and transformation to AML.

Among the most common TEAEs in 78 safety-evaluable patients in Arm 3, those that were Grade 3 were anemia (28%) and thrombocytopenia (5%). Amongst the most common TEAEs, Grade 4 events included thrombocytopenia (3%), anemia (1%), and respiratory tract infection (1%). Two patients discontinued treatment due to TEAEs. In addition, there were two Grade 5 TEAEs, each resulting from multi-organ failure due to sepsis.

EHA Poster Presentations

TITLE: Pelabresib (CPI-0610) improved anemia associated with myelofibrosis: interim results from MANIFEST Phase 2 study (Abstract Code: EP1077) 

TITLE: Clinical benefit of pelabresib (CPI-0610) in combination with ruxolitinib in JAK-inhibitor treatment naïve myelofibrosis patients: Interim efficacy subgroup analysis from Arm 3 of MANIFEST Phase 2 study (Abstract Code: EP1085) 

TITLE: BET inhibitor pelabresib decreases inflammatory cytokines, improves bone marrow fibrosis and function, and demonstrates clinical response irrespective of mutation status in myelofibrosis patients (Abstract Code: EP1080) 

Date and Time: June 11, 9:00 AM CEST/ 3:00 AM EDT

About MANIFEST

MANIFEST is an open-label Phase 2 clinical trial of pelabresib (CPI-0610) in patients with myelofibrosis (MF), a rare cancer of the bone marrow that disrupts the body’s normal production of blood cells. Constellation is evaluating pelabresib in combination with ruxolitinib in JAK-inhibitor-naïve MF patients (Arm 3), with a primary endpoint of the proportion of patients with a ≥35% spleen volume reduction from baseline (SVR35) after 24 weeks of treatment. Constellation Pharmaceuticals is also evaluating pelabresib either as a monotherapy in patients who are resistant to, intolerant of, or ineligible for ruxolitinib and no longer on the drug (Arm 1), or as add-on therapy in combination with ruxolitinib in patients with a sub-optimal response to ruxolitinib or MF progression (Arm 2). Patients in Arms 1 and 2 are being stratified based on TD status. The primary endpoint for the patients in cohorts 1A and 2A, who were TD at baseline, is conversion to transfusion independence for 12 consecutive weeks. The primary endpoint for patients in cohorts 1B and 2B, who were not TD at baseline, is the proportion of patients with a ≥35% spleen volume reduction from baseline after 24 weeks of treatment. 

About Constellation Pharmaceuticals 

Constellation Pharmaceuticals is a clinical-stage biopharmaceutical company developing novel therapeutics that selectively modulate gene expression to address serious unmet medical needs in patients with cancer. The Company has a deep understanding of how epigenetic and chromatin modifications in cancer cells and in the tumor and immune microenvironment play a fundamental role in driving disease progression and drug resistance. Constellation is driving development of the BET inhibitor pelabresib for the treatment of myelofibrosis as well as the EZH2 inhibitor CPI-0209 for the treatment of advanced malignancies. The Company is also applying its broad research and development capabilities to explore other novel targets that directly and indirectly impact gene expression to fuel a sustainable pipeline of innovative small-molecule product candidates.

Forward-Looking Statements 

This press release contains forward-looking statements within the meaning of Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including statements regarding the Company’s plans, strategies and prospects for its business and statements regarding the development status of the Company’s product candidates, the timing of availability of clinical trial data and the Company’s ability to fund its operations until mid-2023. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with: the Company’s ability to obtain and maintain necessary approvals from the FDA and other regulatory authorities; the Company’s ability to continue to advance its product candidates in clinical trials; whether preliminary or interim data from a clinical trial will be predictive of the final results of the trial; replication in later clinical trials positive results found in preclinical studies and early-stage clinical trials of pelabresib (CPI-0610), CPI-1205 and CPI-0209; the Company’s ability to advance the development of its product candidates under the timelines it anticipates, or at all, in current and future clinical trials; the Company’s ability to obtain, maintain, or protect intellectual property rights related to its product candidates; manage expenses; the Company’s ability to raise the substantial additional capital needed to achieve its business objectives; the COVID-19 pandemic and general economic and market conditions; and whether the previously announced acquisition of the Company by MorphoSys AG will be consummated on a timely basis. CPI-0610, CPI-1205 and CPI-0209 are investigational therapies and have not been approved by the FDA (or any other regulatory authority). For a discussion of other risks and uncertainties, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, see the “Risk Factors” section, as well as discussions of potential risks, uncertainties, and other important factors, in the Company’s most recent filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date hereof and should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. 

Contacts 

Kia Khaleghpour, Ph.D. 
Vice President, Investor Relations and Communications 
Constellation Pharmaceuticals 
+1 617-844-6859 
[email protected] 
  
Helen O’Gorman  
FTI Consulting  
+1 718-408-0800   
Helen.O’[email protected]  



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World’s Leading Proxy Advisory Firms ISS and Glass Lewis Recommend T2 Biosystems Stockholders Vote “FOR” the Charter Amendment Proposal – To Increase the Number of Authorized Shares of Common Stock

LEXINGTON, Mass., June 11, 2021 (GLOBE NEWSWIRE) — T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens, today announced that leading proxy advisory firms Institutional Shareholder Services Inc. (ISS) and Glass Lewis and Co., LLC (Glass Lewis), in addition to the Company’s Board of Directors, have recommended that T2 Biosystems stockholders vote in favor of the proposal to amend the Company’s Certification of Incorporation to increase the number of authorized shares of common stock (the “Charter Amendment Proposal”) at the upcoming annual stockholder meeting to be held on June 25, 2021.

T2 Biosystems’ President and CEO, John Sperzel, has previously released a statement communicating to stockholders the importance of this year’s proposals and their potential impact on the Company. The video statement can be found on the Investor Relations section of the Company’s website at investors.t2biosystems.com.

T2 Biosystems, Inc. will be holding its Annual Meeting virtually on June 25, 2021 at 9:00 a.m. Eastern Time at www.virtualshareholdermeeting.com/TTOO2021. T2 Biosystems’ stockholders of record as of April 28, 2021 are entitled to vote at the Annual Meeting. However, all stockholders are encouraged to vote ahead of the meeting, even if you are planning to attend.

T2 Biosystems’ definitive proxy materials, 2020 Annual Report to Stockholders and other relevant information can be found at www.sec.gov.

If you have any questions about how to vote your shares, or need additional assistance, please contact our proxy solicitor, MacKenzie Partners, toll-free at 1-800-322-2885.

About T2 Biosystems

T2 Biosystems, a leader in the rapid detection of sepsis-causing pathogens, is dedicated to improving patient care and reducing the cost of care by helping clinicians effectively treat patients faster than ever before. T2 Biosystems’ products include the T2Dx® Instrument, T2Candida® Panel, the T2Bacteria® Panel, the T2Resistance® Panel, and the T2SARS-CoV-2™ Panel and are powered by the proprietary T2 Magnetic Resonance (T2MR®) technology. T2 Biosystems has an active pipeline of future products, including the T2Cauris™ Panel, and T2Lyme™ Panel, as well as additional products for the detection of bacterial and fungal pathogens and associated antimicrobial resistance markers, and biothreat pathogens.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the stockholder proposals and their potential impact, as well as statements that include the words “expect,” “intend,” “plan”, “believe”, “project”, “forecast”, “estimate,” “may,” “should,” “anticipate,” and similar statements of a future or forward looking nature. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, (i) any inability to (a) realize anticipated benefits from commitments, contracts or products; (b) successfully execute strategic priorities; (c) bring products to market; (d) expand product usage or adoption; (e) obtain customer testimonials; (f) accurately predict growth assumptions; (g) realize anticipated revenues; (h) incur expected levels of operating expenses; or (i) increase the number of high-risk patients at customer facilities; (ii) failure of early data to predict eventual outcomes; (iii) failure to make or obtain anticipated FDA filings or clearances within expected time frames or at all; or (iv) the factors discussed under Item 1A. “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, filed with the U.S. Securities and Exchange Commission, or SEC, on March 31, 2021, and other filings the Company makes with the SEC from time to time. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, unless required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. Thus, no one should assume that the Company’s silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release.

Important Information

The Company, its directors, director nominees and certain of its executive officers are participants in the solicitation of proxies from stockholders in respect of the Annual Meeting. The Company has filed a definitive proxy statement and associated proxy card in connection with the solicitation of proxies for the Annual Meeting with the SEC. Details concerning the nominees of the Company’s board of directors for election at the Annual Meeting are set forth in the definitive proxy statement. BEFORE MAKING ANY VOTING DECISION, STOCKHOLDERS OF THE COMPANY ARE URGED TO READ ALL RELEVANT DOCUMENTS FILED WITH OR FURNISHED TO THE SEC, INCLUDING THE COMPANY’S DEFINITIVE PROXY STATEMENT AND ANY SUPPLEMENTS THERETO, AS THEY CONTAIN IMPORTANT INFORMATION. Information regarding the identity of the Company’s participants and their respective interests in the matters to be voted on at the Annual Meeting, by security holdings or otherwise, are set forth in the definitive proxy statement and other documents filed with the SEC in connection with the Annual Meeting. Investors and stockholders can obtain a copy of the definitive proxy statement and other documents filed by the Company free of charge from the SEC’s website at www.sec.gov. The Company’s stockholders can also obtain, without charge, a copy of the definitive proxy statement and other relevant filed documents from the “SEC Filings” section of the Company’s website at www.t2biosystems.com

Media Contact:

Gina Kent, Vault Communications
[email protected]
610-455-2763

Investor Contact:

Philip Trip Taylor, Gilmartin Group
[email protected]
415-937-5406



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Marchex to Participate in the Northland Customer Engagement SaaS Conference

Marchex to Participate in the Northland Customer Engagement SaaS Conference

SEATTLE–(BUSINESS WIRE)–Marchex, Inc. (NASDAQ: MCHX), a leading provider of conversational analytics and solutions that connects the voice of the customer to your business, announced today that members of the Marchex management team will participate in the following conference:

2021 Northland Capital Markets Customer Engagement SaaSConference

Date: Wednesday, June 16th

Presentation Time: 10:30am PT, Fireside Chat

The live audio webcast of the Marchex presentation will be available by visiting the Event Calendar in the Investor Relations section of the Marchex website (http://investors.marchex.com/event-calendar). An archived version of the webcast will be available four hours after the completion of the presentation.

About Marchex

Marchex understands the best customers are those who call your company – they convert faster, buy more, and churn less. Marchex provides solutions that help companies drive more calls, understand what happens on those calls, and convert more of those callers into customers. Our actionable intelligence strengthens the connection between companies and their customers, bridging the physical and digital world, to help brands maximize their marketing investments and operating efficiencies to acquire the best customers.

Please visit www.marchex.com, www.marchex.com/blog or @marchex on Twitter (Twitter.com/Marchex), where Marchex discloses material information from time to time about the company, its financial information, and its business.

Marchex, Inc.

Investor Relations

Trevor Caldwell, 206-331-3600

[email protected]

KEYWORDS: Washington United States North America

INDUSTRY KEYWORDS: Marketing Data Management Communications Technology Search Engine Marketing Software

MEDIA:

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Atossa Therapeutics Receives Approval from Swedish Regulators to Initiate Phase 2 Clinical Study of Oral Endoxifen to Reduce Mammographic Breast Density

SEATTLE, June 11, 2021 (GLOBE NEWSWIRE) — Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in oncology and infectious disease with a current focus on breast cancer and COVID-19, announces that it has received approval from the Swedish Medical Product Agency (MPA) to initiate a Phase 2 clinical study of its oral Endoxifen for the reduction of mammographic breast density (MBD). MBD is an emerging public health issue affecting more than 10 million women in the United States and many more worldwide. Studies conducted by others have shown that MBD reduces the ability of mammograms to detect cancer (sensitivity) and increases the risk of developing breast cancer. Additional studies show a correlation between reducing MBD and a reduction in the incidence of breast cancer.

“This is a critical milestone in the development of our oral Endoxifen,” commented Steven Quay, M.D., Ph.D., Atossa’s Chairman and CEO. “We now plan to commence the study as soon as restrictions for COVID-19 in Stockholm allow and we are encouraged that daily and weekly average COVID-19 cases have been steadily declining in Sweden over the past six weeks. If this trend continues, we expect to initiate the study in the next quarter. We have also received useful input from the MPA about the development path for Endoxifen. Based in part on that input we will consider conducting future studies to measure the treatment effect of Endoxifen not only on MBD reduction but also on the reduction of the incidence of breast cancer. In addition to clinical data, regulators will require that we also develop preclinical information including toxicology studies and information about manufacturing oral Endoxifen prior to regulatory approval. We have now established two manufacturing sources of Endoxifen for clinical and potential future commercial use and we have initiated a significant portion of the preclinical studies needed for a New Drug Application.”

The primary objective of the MBD study is to determine the dose-response relationship of daily oral Endoxifen on mammographic breast density reduction, with secondary endpoints assessing safety and tolerability. The Phase 2 study will be randomized, double-blinded and placebo-controlled. It will be conducted in Stockholm and will include approximately 240 pre-menopausal women with measurable MBD who will receive daily doses of oral Endoxifen or placebo for six months. South General Hospital in Stockholm will be conducting the study. The study is being led by principal investigator Per Hall, M.D., Ph.D., Head of the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet. The study is also subject to approval by the institutional ethics committees and enrollment will not begin unless and until all approvals are obtained and COVID restrictions are lifted in Sweden.

About Atossa Therapeutics

Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in oncology and infectious diseases with a current focus on breast cancer and COVID-19. For more information, please visit www.atossatherapeutics.com.

Forward-Looking Statements

Forward-looking statements in this press release, which Atossa undertakes no obligation to update, are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with any variation between interim and final clinical results, actions and inactions by the FDA, the outcome or timing of regulatory approvals needed by Atossa including those needed to commence studies of AT-H201, AT-301 and Endoxifen, lower than anticipated rate of patient enrollment, estimated market size of drugs under development, the safety and efficacy of Atossa’s products, performance of clinical research organizations and investigators, obstacles resulting from proprietary rights held by others such as patent rights, whether reduction in Ki-67 or any other result from a neoadjuvant study is an approvable endpoint for oral Endoxifen, and other risks detailed from time to time in Atossa’s filings with the Securities and Exchange Commission, including without limitation its periodic reports on Form 10-K and 10-Q, each as amended and supplemented from time to time.

Company Contact:
Atossa Therapeutics, Inc.
Kyle Guse CFO and General Counsel
Office: (866) 893-4927
[email protected] 

Investor Relations Contact:
Core IR
Office: (516) 222-2560
[email protected] 

Source: Atossa Therapeutics, Inc.



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T-Mobile US, Inc. to Present at the Credit Suisse 23rd Annual Communications Conference

T-Mobile US, Inc. to Present at the Credit Suisse 23rd Annual Communications Conference

BELLEVUE, Wash.–(BUSINESS WIRE)–
Peter Osvaldik, executive vice president & chief financial officer of T-Mobile US, Inc. (NASDAQ: TMUS), will present and provide a business update on Tuesday, June 15, 2021 at 4:35 p.m. Eastern Daylight Time (EDT) at the Credit Suisse 23rd Annual Communications Conference.

A live webcast of the virtual event will be available on the Company’s Investor Relations website at http://investor.t-mobile.com. An on-demand replay will be available shortly after the conclusion of the presentation.

To automatically receive T-Mobile financial news by e-mail, please visit the T-Mobile Investor Relations website, http://investor.t-mobile.com, and subscribe to E-mail Alerts.

About T-Mobile US, Inc.

T-Mobile U.S. Inc. (NASDAQ: TMUS) is America’s supercharged Un-carrier, delivering an advanced 4G LTE and transformative nationwide 5G network that will offer reliable connectivity for all. T-Mobile’s customers benefit from its unmatched combination of value and quality, unwavering obsession with offering them the best possible service experience and undisputable drive for disruption that creates competition and innovation in wireless and beyond. Based in Bellevue, Wash., T-Mobile provides services through its subsidiaries and operates its flagship brands, T-Mobile and Metro by T-Mobile. For more information please visit: http://www.t-mobile.com.

Investor Contact:

[email protected]

 

KEYWORDS: Washington United States North America

INDUSTRY KEYWORDS: Mobile/Wireless Technology Telecommunications

MEDIA:

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KANZHUN LIMITED Announces Pricing of Initial Public Offering

BEIJING, June 11, 2021 (GLOBE NEWSWIRE) — KANZHUN LIMITED (“BOSS Zhipin” or the “Company”) (Nasdaq: BZ), a leading online recruitment platform in China, today announced the pricing of its initial public offering of 48,000,000 American Depositary Shares (“ADSs”), at US$19.00 per ADS, for a total offering size of US$912.0 million, assuming the underwriters do not exercise their option to purchase additional ADSs. Each ADS represents two Class A ordinary shares of the Company. The ADSs have been approved for listing and are expected to begin trading on the Nasdaq Global Select Market today under the symbol “BZ”. The offering is expected to close on June 15, 2021, subject to customary closing conditions.

The Company has granted the underwriters an option, exercisable within 30 days from the date of the final prospectus, to purchase up to an aggregate of 7,200,000 additional ADSs at US$ 19.00 per ADS.

Goldman Sachs (Asia) LLC, Morgan Stanley & Co. LLC and UBS Securities LLC (names in alphabetical order) are acting as the lead joint book-running managers and representatives of the underwriters for the offering. China Renaissance Securities (Hong Kong) Limited and Haitong International Securities Company Limited are acting as the joint book-running managers for the offering. Futu Inc. and Tiger Brokers (NZ) Limited are acting as the co-managers for the offering.

A registration statement related to the ADSs
being sold in this offering has been filed with, and declared effective by, the United States Securities and Exchange Commission. This press release shall not constitute an offer to sell or a 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 an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

This offering is being made only by means of a prospectus forming a part of the effective registration statement.
A copy of the final prospectus relating to the offering may be obtained, when available, by contacting the following underwriters: (1) Goldman Sachs (Asia) L.L.C. Attention: Prospectus Department, 200 West Street, New York, NY 10282-2198, U.S.A., by calling +1 (212) 902-1171, or by email at

[email protected]

; (2)
Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, U.S.A.,
by calling +1 (212) 761-6006, or by email at

[email protected]

; (3) UBS Securities LLC, Attention: Prospectus Department,
1285 Avenue of the Americas, New York, NY 10019, U.S.A., by calling +1 (888) 827-7275 or by email at

[email protected]

;
(4) China Renaissance Securities (Hong Kong) Limited, Attention: ECM, Units 8107-08, Level 81, International Commerce Centre, 1 Austin Road West, Kowloon, Hong Kong, by calling +852 2287-1600, or by email at

[email protected]

; (5) Haitong International Securities Company Limited, Attention: Equity Capital Markets, 22/F Li Po Chun Chambers, 189 Des Voeux Road Central, Hong Kong, or by calling +852 2848-4373; (6) Futu Inc., Attention: ECM, 720 University Avenue, Suite 100, Palo Alto, CA 94301, U.S.A., by calling +1 (650) 798-5700, or by email at

[email protected]

; (7) Tiger Brokers (NZ) Limited, Attention: Vincent Cheung, Level 16, 191 Queen Street, Auckland Central, New Zealand, 1010, by calling +64 93-938-128, or by email at [email protected]
.

About BOSS Zhipin

BOSS Zhipin (Nasdaq: BZ) is the largest online recruitment platform in China, in terms of average MAU in 2020. Established seven years ago, the Company connects job seekers and enterprise users in an efficient and seamless manner through its highly interactive mobile app, a transformative product that promotes two-way communication, focuses on intelligent recommendations, and creates new scenarios in the online recruiting process.

BOSS Zhipin has achieved full coverage of users and served a full spectrum of employers. As of March 31, 2021, it had 85.8MM verified job seekers and 13.0MM verified enterprise users, generating an MAU of 30.6MM in March 2021. Benefiting from its large and diverse user base, BOSS Zhipin has developed powerful network effects to deliver higher recruitment efficiency and drive rapid expansion.

BOSS Zhipin has a vision to redefine every individual’s career development with technology and a passion towards delivering user satisfaction, by optimizing efficiency, equality and choice. For more information, please visit http://ir.zhipin.com/.

Safe Harbor Statement

This press release contains statements that may constitute “forward-looking” statements which are made pursuant to the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “aims,” “future,” “intends,” “plans,” “believes,” “estimates,” “likely to,” and similar statements. Statements that are not historical facts, including statements about the Company’s beliefs, plans, and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. Further information regarding these and other risks is included in the Company’s filings with the SEC. All information provided in this press release is as of the date of this press release, and the Company does not undertake any obligation to update any forward-looking statement, except as required under applicable law.

For investor and media inquiries, please contact:

Email: [email protected]

SOURCE KANZHUN LIMITED



Posted on

Intrusion, Inc. Limited Investors: Last Days to Participate Actively in the Class Action Lawsuit; Portnoy Law Firm

Investors with losses are encouraged to contact the firm before
June 15, 2021
; click


here


to submit trade information

LOS ANGELES, June 11, 2021 (GLOBE NEWSWIRE) — The Portnoy Law Firm advises investors that a class action lawsuit has been filed on behalf of Intrusion, Inc. (NASDAQ: INTZ) investors that acquired shares between January 13, 2021 and April 13, 2021. Investors have until June 15, 2021 to seek an active role in this litigation.

Investors are encouraged to contact attorney Lesley F. Portnoy, to determine eligibility to participate in this action, by phone 310-692-8883 or email, or click here to join the case.

White Diamond Research published a report on April 14, 2021 alleging, among other things, that Intrusion’s product, Shield, “has no patents, certifications, or insurance, which are all essential for selling cybersecurity products” and that “Shield is based on open-source data already available to the public.” It was stated in this report that “Shield is a repackaging of pre-existing technology rather than an innovative offering.” This report also alleged that the claims that Shield “stopp[ed] a total of 77,539,801 cyberthreats from 805,110 uniquely malicious entities . . . in the 90-day beta program” were “outlandish,” which led White Diamond to question “[h]ow have these companies been able to function so far, as they’ve been attacked many times per minute by ransomware, malware, data theft, phishing and DDoS attacks?”. During intraday trading on April 14, 2021, Intrusion’s share price fell as much as 11%, based on this news.

A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than June 15, 2021.

Please visit our website to review more information and submit your transaction information.

The Portnoy Law Firm represents investors in pursuing arising from corporate wrongdoing. The Firm’s founding partner has recovered over $5.5 billion for aggrieved investors. Attorney advertising. Prior results do not guarantee similar outcomes.

Lesley F. Portnoy, Esq.
Admitted CA and NY Bar
[email protected]
310-692-8883
www.portnoylaw.com

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