Willis Towers Watson expands aviation insurance broking expertise and solutions with acquisition of Aerosure

Acquisition cements WTW’s position as a leading aviation broker in Asia and Australasia

SYDNEY, Australia, Dec. 05, 2021 (GLOBE NEWSWIRE) — Willis Towers Watson (NASDAQ: WLTW), a leading global advisory, broking and solutions company, today announced the acquisition of Aerosure, a leading aviation industry specialist, focused on the Australia, New Zealand and Pacific Island region.

Aerosure, based in Sydney, will become a part of Willis Towers Watson’s (WTW) Global Aerospace business, providing a suite of aviation insurance broking solutions to service the insurance and risk needs of the aviation industry in Australia and New Zealand, as well as the broader Asia Pacific region. Greg Rector, current Managing Director of Aerosure, will move into WTW as Managing Director, Australasia Aviation Division, and will be joined by his colleagues from Aerosure.

Over the last two years, the COVID-19 pandemic has created unprecedented disruption in the global aviation industry. It is expected that domestic and international flights will start to return gradually as countries reopen their borders and move to a new normal. WTW plays a key role in supporting the aviation industry globally with its expertise in understanding the sector’s key risks and concerns, managing complex challenges and advising aviation companies and operators on the optimal insurance coverage needed to meet their long-term risk management needs. This industry support extends to WTW’s Airport Risk Community (ARC), a knowledge sharing network that facilitates global connectivity between groups of professionals to help them understand and take action on emerging risks and industry trends.

Commenting on the acquisition, Head of Corporate Risk & Broking, Asia and Australasia, and Head of Australasia, Simon Weaver, said: “Aerosure is a leading aviation industry specialist with a large book of aviation focused industry clients, including airlines, airports and air traffic control, committed to the long-term position of its clients. Over the years, it has not only grown to become the pre-eminent specialist Aviation broker in the region but has contributed to the growth and development of the aerospace community in Australia and New Zealand.

WTW has worked in close partnership with Aerosure to provide services to local aviation clients for many years. We already know that the Aerosure team shares our values and ethos. Bringing them into WTW reflects our global strategy to work with high-performing and high-potential businesses in our chosen markets and industry sectors. With this acquisition, we see great opportunities in providing additional services and solutions to clients throughout Asia and Australasia, supporting companies and operators as they return to normality.”

John Rooley, CEO, Global Aerospace, WTW, added: “We are very excited by the deal and delighted that the highly talented Aerosure team is joining WTW. By combining the capabilities of Aerosure, this acquisition further expands the footprint of our aerospace business, enhancing our client offering both locally and globally as the teams work together with our aviation specialists in over 35 locations across the WTW network. The combination of our teams will strengthen our value proposition for our clients as a world-leading insurance broker and trusted risk adviser in the aerospace industry, providing them with a wide and deep range of solutions.”

Greg Rector, Managing Director, Aerosure, said: “We are delighted to take our partnership with WTW to the next level to provide added value to all of our aviation focused industry clients. This partnership has proven to be an industry leading proposition for all of our clients and we are extremely excited to be cementing our relationship for the benefit of all our clients across Australia, New Zealand and the Pacific Islands.”

The acquisition is effective immediately.

About Willis Towers Watson

Willis Towers Watson (NASDAQ: WLTW) is a leading global advisory, broking and solutions company that helps clients around the world turn risk into a path for growth. With roots dating to 1828, Willis Towers Watson has 45,000 employees serving more than 140 countries and markets. We design and deliver solutions that manage risk, optimise benefits, cultivate talent, and expand the power of capital to protect and strengthen institutions and individuals. Our unique perspective allows us to see the critical intersections between talent, assets and ideas – the dynamic formula that drives business performance. Together, we unlock potential. Learn more at willistowerswatson.com.

Media contact

Asia Pacific – Clara Goh: +65 6958 2542 | [email protected]
Australia and New Zealand – Claire King: +61 3 8681 9708 | [email protected]



Alibaba Group Announces CFO Succession

Alibaba Group Announces CFO Succession

Toby Xu named as CFO, Maggie Wu to continue as board director in planned transition

HANGZHOU, China–(BUSINESS WIRE)–
Alibaba Group Holding Limited (NYSE: BABA and HKEX: 9988, “Alibaba” or “Alibaba Group”) today announced that Toby Xu, Deputy Chief Financial Officer, will succeed Maggie Wu as the Company’s Chief Financial Officer, effective April 1, 2022. Maggie will continue as a partner in the Alibaba Partnership and serve as an executive director on the Alibaba board.

“Maggie has made exceptional contributions that are instrumental to Alibaba’s achievements to date. Since joining Alibaba almost fifteen years ago, Maggie has helped lead three successful company public listings as CFO: Alibaba.com on the Hong Kong Stock Exchange in 2007, and Alibaba Group Holding on the New York Stock Exchange in 2014 and on the Hong Kong Stock Exchange in 2019. She has built and nurtured a finance team with professional capabilities and accomplishments second to none, and has served as our bedrock in pursuing Alibaba’s strategies and business development. Maggie is forever calm and unflappable, regardless of ups and downs in the global capital markets and macro environment. She is humble and resilient, and has been my irreplaceable and closest partner over the years,” said Daniel Zhang, Chairman and CEO of Alibaba Group. “Going forward, Maggie will leverage her deep experience to support Alibaba in new ways. We will continue to benefit from her guidance and insights in her continued role as an Alibaba board director.”

“We are focused on the long-term, and succession within our management team on every occasion is always in the service of ensuring Alibaba will be stronger and better positioned for the future,” said Zhang. “Toby joined Alibaba from PwC three years ago and was appointed Deputy Group CFO in July 2019. He swiftly demonstrated his solid capabilities and leadership in response to our continually evolving businesses. He took on increasing responsibilities that grew to include our strategic investments, in addition to financial management and operations. We are certain that Toby is the right person to serve as our new Group CFO and, together with the core management team, will help lead our team towards our next success.”

“The announcement of Alibaba’s CFO transition today is the culmination of extensive preparation over many years and a part of Alibaba’s leadership succession planning. The markets will always have ups and downs, but Alibaba has ambitious long-term goals. We are in a relay race and we must have new generations of talent to take the company forward. I trust Toby even more than I trusted myself when I first took up the CFO position years ago. I am confident that Toby – through his professional capabilities and leadership skills, and together with Daniel and the core management team – will successfully lead our team into the future,” said Maggie Wu, Chief Financial Officer of Alibaba Group.

Toby joined Alibaba in July 2018 and was appointed Deputy Chief Financial Officer in July 2019. Before joining Alibaba Group, Toby was a partner at PricewaterhouseCoopers for 11 years, where he joined in 1996. He serves as a director of Sun Art Retail Group, Lianhua Supermarket Holdings and Red Star Macalline Group. Toby graduated from Fudan University in Shanghai, China, with a bachelor’s degree in Physics in 1996. He is a member of the Chinese Institute of Certified Public Accountants.

About Alibaba Group

Alibaba Group’s mission is to make it easy to do business anywhere. The company aims to build the future infrastructure of commerce. It envisions that its customers will meet, work and live at Alibaba, and that it will be a good company that lasts for 102 years.

Grace Shao

Alibaba Group

+852 9857 2779

[email protected]

Liyan Chen

Alibaba Group

+1 515 864 1116

[email protected]

KEYWORDS: China Asia Pacific

INDUSTRY KEYWORDS: Online Retail Data Management Retail Technology Software Internet

MEDIA:

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HUTCHMED Completes Planned Enrollment of FRESCO-2, a Global Phase III Trial of Fruquintinib in Metastatic Colorectal Cancer

— Recruitment of 687 patients globally completed in fifteen months, ahead of schedule —

— FRESCO-2 primary objective is to confirm overall clinical benefit seen in the China FRESCO pivotal study

1

, and to support global registrations —

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Dec. 06, 2021 (GLOBE NEWSWIRE) — HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; HKEX: 13) today announces that it has completed patient enrollment of FRESCO-2, a Phase III registration study of fruquintinib, an investigational treatment for the treatment of patients with metastatic colorectal cancer (“CRC”) in the U.S., Europe, Japan and Australia. The enrollment goal was reached on December 2, 2021.

FRESCO-2 is a randomized, double-blind, placebo-controlled, multicenter trial being conducted in patients with metastatic CRC. The primary endpoint of the study is overall survival (“OS”). This large Phase III trial enrolled patients in over 150 sites in 14 countries. Additional details of the study may be found at clinicaltrials.gov, using identifier NCT04322539.

Dr. Marek Kania, EVP, Managing Director and Chief Medical Officer of HUTCHMED International Corporation, said, “HUTCHMED continues to execute on developing novel oncology medicines for patients worldwide despite the backdrop of the global pandemic. We would like to thank investigators, patients and their families for taking part in this study and we look forward to seeing the results of this study in patients with metastatic CRC, where there is a high unmet need for new treatment options.”

Topline results from the FRESCO-2 trial are expected to be reported in the second half of 2022 when the event-driven primary endpoint, OS, is mature. If positive, HUTCHMED would initiate plans to apply for marketing authorization of fruquintinib by the U.S. Food and Drug Administration (“FDA”), the European Medicines Agency (“EMA”) and the Japanese Pharmaceuticals and Medical Devices Agency (“PMDA”). The U.S. FDA granted Fast Track Designation for the development of fruquintinib for the treatment of patients with metastatic CRC in June 2020. Clinical data from the completed Phase III FRESCO study in Chinese patients, additional supporting studies in CRC and this FRESCO-2 global study, if positive, could support a future U.S. FDA New Drug Application (“NDA”) for the treatment of patients with advanced metastatic CRC (third-line and later). The FRESCO-2 study design was also reviewed and endorsed by the EMA and PMDA.

HUTCHMED retains all commercial rights to fruquintinib outside of China. In China, where fruquintinib is marketed under the brand name ELUNATE®, HUTCHMED is partnered with Eli Lilly and Company and is responsible for development and execution of all on-the-ground medical detailing, promotion and local and regional marketing. Fruquintinib is not approved for use outside of China.

About CRC

CRC is a cancer that starts in either the colon or rectum. CRC is the third most common cancer worldwide, estimated to have caused more than 915,000 deaths in 2020.2 In the U.S., an estimated 150,000 people will have been diagnosed with CRC and 53,000 people will have died from CRC in 2021.3 In Europe, CRC is the second most common cancer, with an estimated 507,000 new cases and 240,000 deaths in 2020.2 In Japan, CRC is the most common cancer, with an estimated 147,000 new cases and 59,000 deaths in 2020.2

About Fruquintinib

Fruquintinib is a highly selective and potent oral inhibitor of VEGFR-1, -2 and -3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability and provide more consistent target coverage. The generally good tolerability in patients to date, along with fruquintinib’s low potential for drug-drug interaction based on preclinical assessment, suggests that it may also be highly suitable for combinations with other anti-cancer therapies.

About Fruquintinib Approval in China

Metastatic colorectal cancer in China: Fruquintinib was approved for marketing by the China National Medical Products Administration (NMPA) in September 2018 and commercially launched in China in late November 2018 under the brand name ELUNATE®. It was included in the China National Reimbursement Drug List (NRDL) in January 2020. ELUNATE® is indicated for the treatment of patients with metastatic CRC who have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan, including those who have previously received anti-VEGF therapy and/or anti-EGFR therapy (RAS wild type). Results of the FRESCO study1, a Phase III pivotal registration trial of fruquintinib in 416 patients with metastatic CRC in China, were published in The Journal of the American Medical Association, JAMA, in June 2018 (clinicaltrials.gov identifier: NCT02314819).

About Fruquintinib Development Beyond CRC Monotherapy

The safety and efficacy of fruquintinib for the following investigational uses have not been established and there is no guarantee that it will receive health authority approval or become commercially available in any country for the uses being investigated:

Gastric Cancer (“GC”) in China: In October 2017, HUTCHMED initiated the FRUTIGA study, a randomized, double-blind, Phase III trial evaluating the efficacy and safety of fruquintinib combined with paclitaxel for second-line treatment of advanced gastric or esophagogastric junction (“GEJ”) adenocarcinoma. The trial is designed to enroll patients who did not respond to first-line standard chemotherapy. Subjects receive either fruquintinib combined with paclitaxel or placebo combined with paclitaxel. Patients are randomized at a 1:1 ratio and stratified according to factors such as stomach vs. GEJ tumor type and performance status. The primary efficacy endpoint is OS. Secondary efficacy endpoints include progression-free survival (as defined by RECIST 1.1), objective response rate, disease control rate, duration of response, and quality-of-life score (EORTC QLQ-C30, version 3.0). Biomarkers related to the antitumor activity of fruquintinib will also be explored (clinicaltrials.gov identifier: NCT03223376). In June 2020, HUTCHMED completed a planned interim data review. Based on the preset criteria, the Independent Data Monitoring Committee (IDMC) recommended that the trial continue.

Immunotherapy combinations: HUTCHMED has entered into collaboration agreements to evaluate the safety, tolerability and efficacy of fruquintinib in combination with PD-1 monoclonal antibodies, including with tislelizumab (BGB-A317, developed by BeiGene, Ltd) and sintilimab (IBI308, developed by Innovent Biologics, Inc. and marketed as TYVYT® in China).

  • Metastatic breast and endometrial cancers in the U.S.: HUTCHMED initiated this open-label, multi-center, non-randomized, Phase Ib/II study in the U.S. to assess the safety and efficacy of fruquintinib in combination with tislelizumab in patients with advanced, refractory triple negative breast cancer (“TNBC”) and endometrial cancer (“EMC”). This study is being conducted to investigate if the addition of fruquintinib can potentially induce activity to immune checkpoint inhibitor therapy in TNBC and EMC. Additional details of the study may be found at clinicaltrials.gov, using identifier NCT04577963. Safety and preliminary efficacy of fruquintinib were demonstrated in advanced solid tumors, including TNBC, in a Phase I study conducted in China (NCT01645215) and a Phase I/Ib study is ongoing in the United States (NCT03251378).

  • Gastric, colorectal and non-small cell lung cancers in China & Korea: BeiGene, Ltd. initiated this open-label, multi-center, Phase II study to assess the safety and efficacy of fruquintinib in combination with tislelizumab in patients with advanced or metastatic, unresectable GC, CRC or non-small cell lung cancer (“NSCLC”). Additional details of the study may be found at clinicaltrials.gov, using identifier NCT04716634.

  • Solid tumors in China: HUTCHMED initiated this open-label, multi-center, non-randomized, Phase II study to assess the safety and efficacy of fruquintinib in combination with sintilimab in patients with advanced cervical cancer, EMC, GC, hepatocellular carcinoma (HCC), NSCLC or renal cell carcinoma (RCC). Additional details of the study may be found at clinicaltrials.gov, using identifier NCT03903705. Preliminary results of certain cohorts were presented at the 2021 American Society of Clinical Oncology Annual Meeting (ASCO) and the Chinese Society of Clinical Oncology Annual Meeting (CSCO).

About HUTCHMED

HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery, global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has more than 4,500 personnel across all its companies, at the center of which is a team of over 1,400 in oncology/immunology. Since inception it has advanced eleven cancer drug candidates from in-house discovery into clinical studies around the world, with its first three oncology drugs now approved and marketed in China. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.


Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including its expectations regarding the therapeutic potential of fruquintinib for the treatment of patients with advanced CRC and the further clinical development of fruquintinib in this and other indications. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the sufficiency of clinical data to support NDA approval of fruquintinib for the treatment of patients with advanced CRC in the U.S., Europe, Japan, Australia or other jurisdictions, its potential to gain expeditious approvals from regulatory authorities, the safety profile of fruquintinib, HUTCHMED’s ability to fund, implement and complete its further clinical development and commercialization plans for fruquintinib, the timing of these events, and the impact of the COVID-19 pandemic on general economic, regulatory and political conditions. In addition, as certain studies rely on the use of other drug products such as paclitaxel, tislelizumab and sintilimab as combination therapeutics with fruquintinib, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of these therapeutics. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the U.S. Securities and Exchange Commission, on AIM and on The Stock Exchange of Hong Kong Limited. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

CONTACTS

Investor Enquiries  
Mark Lee, Senior Vice President +852 2121 8200
Annie Cheng, Vice President +1 (973) 567 3786
   
Media Enquiries  
Americas – Brad Miles,
Solebury Trout
+1 (917) 570 7340 (Mobile)
[email protected]
Europe – Ben Atwell / Alex Shaw,
FTI Consulting
+44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile)
[email protected]
Asia – Zhou Yi,
Brunswick
+852 9783 6894 (Mobile)
[email protected]
   
Nominated Advisor  
Atholl Tweedie / Freddy Crossley,
Panmure Gordon (UK) Limited
+44 (20) 7886 2500

_________________________________________

1 Li J, Qin S, Xu RH, et al. Effect of Fruquintinib vs Placebo on Overall Survival in Patients With Previously Treated Metastatic Colorectal Cancer: The FRESCO Randomized Clinical Trial. JAMA. 2018;319(24):2486-2496. doi:10.1001/jama.2018.7855.
2The Global Cancer Observatory. Accessed September 21, 2021.
3 SEER. Cancer Stat Facts: Colorectal Cancer. National Cancer Institute. https://seer.cancer.gov/statfacts/html/colorect.html. Accessed September 21, 2021.



Rexlemestrocel-L Shows Greatest Treatment Benefit on Major Adverse Cardiovascular Events in High-Risk Heart Failure Patients With Diabetes and/or Myocardial Ischemia

Endpoint in Line with FDA Guidance on Key Outcomes in High-Risk Patients and with Pharma Industry Drugs Approved for Cardiovascular Risk Reduction in Diabetes

Key points:

  • Analysis of pre-specified high-risk groups in the DREAM-HF Phase 3 trial of rexlemestrocel-L in patients with chronic heart failure and low ejection fraction (HFrEF) showed greatest treatment benefit in major adverse cardiovascular events (MACE) of cardiovascular mortality or irreversible morbidity (non-fatal heart attack or stroke) in patients with diabetes and/or myocardial ischemia (72% of total treated population)  
  • This target population is at very high risk for mortality and irreversible morbidity due to micro- and macro-vascular disease despite receiving optimal standard of care therapies 1
  • Rexlemestrocel-L, added to optimal standard of care therapies, reduced the 3-point MACE composite of cardiovascular death or heart attack or stroke by 37% across all HFrEF patients with diabetes and/or ischemia and by 54% in HFrEF patients with systemic inflammation (elevated baseline hs-CRP)
  • United States Food & Drug Administration (FDA) has previously accepted 3-point MACE reductions of 12-14% for approval of multiple pharmaceutical industry drugs to reduce cardiovascular risk in diabetic patients 2,3
  • FDA confirmed that reduction in cardiovascular mortality or irreversible morbidity (non-fatal heart attack or stroke) is an acceptable clinically meaningful endpoint for determining the treatment benefit of rexlemestrocel-L for patients with HFrEF
  • Mesoblast to formally submit to FDA its new analyses of outcomes in high-risk HFrEF patients with diabetes and/or myocardial ischemia to agree on a potential pathway to approval.

NEW YORK, Dec. 05, 2021 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided new analyses from the landmark DREAM-HF Phase 3 trial showing that the greatest treatment benefit from rexlemestrocel-L is in HFrEF patients with diabetes and/or ischemia, who are at high-risk of cardiovascular mortality, heart attacks or strokes.

In recent guidance to Mesoblast, FDA confirmed that reduction in incidence of cardiovascular mortality or irreversible morbidity (non-fatal heart attack or stroke) is a clinically meaningful acceptable endpoint in patients with chronic HFrEF and encouraged Mesoblast to identify the highest-risk group with greatest likelihood of beneficial response to intervention with rexlemestrocel-L in the DREAM-HF Phase 3 trial.

In line with this guidance, Mesoblast performed additional analyses of MACE outcomes in pre-specified high-risk patient groups from the landmark DREAM-HF trial, and the results were presented December 3 by Chief Executive Dr Silviu Itescu at the 18th Global CardioVascular Clinical Trialists Forum (CVCT) in Washington DC.

The data showed that:

  • While a single rexlemestrocel-L dose on top of maximal standard of care therapies reduced the composite 3-point MACE in all 537 patients by 33% (p=0.02) over a mean follow-up of 30 months, a hierarchical analysis across pre-specified high-risk subgroups showed greatest benefit in patients with diabetes and/or myocardial ischemia (hazard ratio 0.63, p=0.019)
  • Among control patients with HFrEF (n=276) all of whom were treated with maximal available standard of care therapies, risk of 3-point MACE was 1.9-fold higher in controls with diabetes and/or myocardial ischemia (n=192) than controls with neither diabetes nor myocardial ischemia (n=84), p=0.02. This confirmed the ongoing high-risk of 3-point MACE in control patients with diabetes and/or myocardial ischemia due to micro- and macro-vascular disease despite receiving optimal standard of care therapies
  • Compared to control patients, rexlemestrocel-L reduced the incidence of 3-point MACE by 37% overall in NYHA class II or III HFrEF patients with diabetes and/or myocardial ischemia (n=385, p=0.02) and by 54% in those with diabetes and/or myocardial ischemia who had evidence of systemic inflammation, as defined by elevated baseline levels of hs-CRP >2mg/L (n=212, p=0.003).

Diabetes Mellitus is not only a significant risk factor in the onset of heart failure, it also increases the risk of mortality and morbidity in patients who have existing heart failure.1-3 Type 2 diabetes causes structural heart disease and heart failure through myocardial ischemia involving small and large vessels. Importantly, inflammation which is a critical component of the pathophysiology of the disease is also known to accelerate large vessel atherosclerosis.1

The 3-point composite MACE is an endpoint the FDA has previously accepted for approval of multiple drugs to reduce cardiovascular risk in diabetic patients. FDA guidance states that reliance on a single study to provide the substantial evidence of effectiveness necessary to support a Biologic License Application (BLA) is generally limited to situations in which a trial has demonstrated a clinically meaningful effect on mortality, irreversible morbidity, or prevention of a disease with potentially serious outcome for which confirmation of the result with a second trial would be practically or ethically impossible. Mesoblast will submit for formal FDA review the new data analyses showing the reduction in mortality and irreversible morbidity by rexlemestrocel-L in HFrEF patients with diabetes and/or myocardial ischemia, to agree on a potential pathway to approval.

About Mesoblast

Mesoblast is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of late-stage product candidates which respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process.

Mesoblast has a strong and extensive global intellectual property portfolio with protection extending through to at least 2041 in all major markets. The Company’s proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.

Mesoblast is developing product candidates for distinct indications based on its remestemcel-L and rexlemestrocel-L stromal cell technology platforms. Remestemcel-L is being developed for inflammatory diseases in children and adults including steroid refractory acute graft versus host disease and moderate to severe acute respiratory distress syndrome. Rexlemestrocel-L is in development for advanced chronic heart failure and chronic low back pain. Two products have been commercialized in Japan and Europe by Mesoblast’s licensees, and the Company has established commercial partnerships in Europe and China for certain Phase 3 assets.

Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast

Footnotes

  1. Dunlay SM., et al. Circulation. 2019;140:e294–e324
  2. Wang CCL et al. Circulation 2019; 139: 1741-1743.
  3. McGuire DK et al. JAMA Cardiol. 2021; 6:148-158.

Forward-Looking Statements

This announcement includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. All statements other than statements of historical fact, including our intention to agree with FDA on a potential pathway to approval, are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “likely,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions and variations thereof. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. The risks, uncertainties and other factors that may impact our forward-looking statements include, but are not limited to: the timing, progress and results of Mesoblast’s preclinical and clinical studies; Mesoblast’s ability to advance product candidates into, enroll and successfully complete, clinical studies; the timing or likelihood of regulatory filings and approvals; whether the FDA agrees to a regulatory pathway; and the pricing and reimbursement of Mesoblast’s product candidates, if approved; Mesoblast’s ability to establish and maintain intellectual property on its product candidates and Mesoblast’s ability to successfully defend these in cases of alleged infringement. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast’s actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. Unless required by law, we do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.

Release authorized by the Chief Executive.

For more information, please contact:


Corporate Communications / Investors

Media
Paul Hughes Sumit Media
T: +61 3 9639 6036 Grant Titmus
E: [email protected] T: +61 419 388 161
  E: [email protected]
   
  Rubenstein
  Nadine Woloshin
  T: +1 917-699-9456
  E: [email protected]



Aeglea BioTherapeutics to Host Conference Call to Report Phase 3 Topline Results of Pegzilarginase in Patients with Arginase 1 Deficiency

Event Scheduled for 8:00 a.m. ET Monday, December 6, 2021

PR Newswire

AUSTIN, Texas, Dec. 5, 2021 /PRNewswire/ — Aeglea BioTherapeutics, Inc. (NASDAQ: AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics as innovative solutions for rare metabolic diseases, today announced that it will host an investor conference call and webcast tomorrow morning to discuss the topline results from the PEACE Phase 3 clinical trial of pegzilarginase in patients with Arginase 1 Deficiency (ARG1-D).

Investors and the public are invited to listen to a live audio webcast of the conference call on December 6, 2021, at 8:00am ET, which can be accessed prior to the start of the call by dialing 1-877-425-9470 (U.S.) or 1-201-389-0878 (International) Conference ID 13725511 or through the Events & Presentations section of the Company’s website.

About Aeglea BioTherapeutics 
Aeglea BioTherapeutics is a clinical-stage biotechnology company redefining the potential of human enzyme therapeutics to benefit people with rare metabolic diseases with limited treatment options. Aeglea’s lead product candidate, pegzilarginase, is in an ongoing Phase 3 pivotal trial in patients with Arginase 1 Deficiency and has received both Rare Pediatric Disease and Breakthrough Therapy Designations. Aeglea has an ongoing Phase 1/2 clinical trial of AGLE-177 for the treatment of Homocystinuria. AGLE-177 has been granted Rare Pediatric Disease Designation. Aeglea has an active discovery platform focused on engineering small changes in human enzymes to have a big impact on the lives of patients and their families. For more information, please visit http://aeglea.com.

 

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/aeglea-biotherapeutics-to-host-conference-call-to-report-phase-3-topline-results-of-pegzilarginase-in-patients-with-arginase-1-deficiency-301437580.html

SOURCE Aeglea BioTherapeutics, Inc.

Johnson & Johnson COVID-19 Booster, Administered Six Months After Two-Dose Regimen of BNT162b2, Shows Substantial Increase in Antibody and T-cell Responses

Preliminary Phase 2 study and a sub-study demonstrate value of mix-and-match approach; Johnson & Johnson booster increased neutralizing and binding antibodies, similar to boosting with BNT162b2, and showed strong increase in T-cell responses

PR Newswire

NEW BRUNSWICK, N.J., Dec. 5, 2021 /PRNewswire/ — Johnson & Johnson (NYSE: JNJ) (the Company) today announced preliminary results from an independent study, including a subset of participants from the Janssen-sponsored COV2008 study, conducted by Dan Barouch, M.D., Ph.D., et al. of Beth Israel Deaconess Medical Center (BIDMC), which showed that a booster shot of the Johnson & Johnson COVID-19 vaccine (Ad26.COV2.S), administered at six months after a two-dose primary regimen of BNT162b2, increased both antibody and T-cell responses. These results demonstrate the potential benefits of heterologous boosting (mix-and-match). The article describing these results have been posted on medRxiv.

“There is early evidence to suggest that a mix-and-match boosting approach may provide individuals with different immune responses against COVID-19 than a homologous boosting approach,” said Dan Barouch, M.D., Ph.D., Director of the Center for Virology and Vaccine Research at BIDMC. “In this preliminary study, when a booster dose of Ad26.COV2.S was given to individuals six months after a primary regimen with the BNT162b2 vaccine, there was a comparable increase of antibody responses at week four following the boost and a greater increase of CD8+ T-cell responses with Ad26.COV2.S compared with BNT162b2.”

“These results provide valuable scientific insights for our vaccine when used as a mix-and-match booster and can help inform boosting strategies with the goal to curb the pandemic,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. “These data add to the growing body of evidence demonstrating that a mix-and-match booster dose of the Johnson & Johnson COVID-19 vaccine successfully increases humoral responses and cellular responses against the original strain of SARS-CoV-2, as well as the Beta and Delta variants.”

These Phase 2 data are reinforced by preliminary results from the UK COV-BOOST clinical study published in The Lancet, which demonstrated that following primary vaccination with two doses of either BNT162b2 (n=106) or ChAdOx1 nCov-19 (n=108), a booster dose of the Johnson & Johnson COVID-19 vaccine increased both antibody and T-cell responses.

Cellular (T-Cell) Responses
In this preliminary study, boosting with the Johnson & Johnson COVID-19 vaccine after a primary vaccine regimen of BNT162b2 appears to lead to a greater increase in CD8+ T-cell responses than boosting with BNT162b2. These T-cell response data suggest differences between immune responses following homologous boosting with BNT162b2, and mix-and-match boosting with the Johnson & Johnson COVID-19 vaccine following a primary regimen of BNT162b2.

The Johnson & Johnson COVID-19 vaccine leverages Janssen’s AdVac® technology and cell-mediated immunity, including CD4+ and CD8+ responses. T-cells can target and destroy cells infected by the virus that causes COVID-19. Specifically, CD8+ T-cells can directly destroy infected cells and are aided by CD4+ T-cells.

Humoral (Antibody) Responses
Both the Johnson & Johnson COVID-19 vaccine and BNT162b2 as boosters led to similar neutralizing and binding antibody levels against the original SARS-CoV-2 strain, as well as the Delta and Beta variants, four weeks following the boost. However, after a mix-and-match booster dose of the Johnson & Johnson COVID-19 vaccine, antibodies continued to increase for at least four weeks whereas in individuals who received a homologous boost with the BNT162b2 vaccine, antibodies declined from week two to week four post-boost.

Neutralizing antibodies are capable of binding to the virus in a way that blocks infection and confines the virus to the upper respiratory tract. Binding antibodies can bind to the virus’ spike protein and inactivate the virus through non-neutralizing antiviral functionalities.

Study Design
For this study, a specimen biorepository at Beth Israel Deaconess Medical Center (BIDMC) obtained samples from individuals who received the BNT162b2 vaccine. Participants either continued follow-up in the biorepository and were boosted with 30 ug BNT162b2 (n=24) or were enrolled in the COV2008 study (NCT04999111) and were boosted with 5, 2.5, or 1×1010 vp of the Johnson & Johnson COVID-19 vaccine (n=41). The COV2008 study is a Johnson & Johnson sponsored, ongoing, blinded Phase 2 clinical trial (VAC31518COV2008) to evaluate its COVID-19 vaccine as a booster in adults 18 years of age and older.

The U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) has recommended the Johnson & Johnson COVID-19 vaccine as a booster for all eligible individuals aged 18 years and older who receive an authorized COVID-19 vaccine.

Johnson & Johnson continues to submit relevant data to other regulators, the World Health Organization (WHO) and National Immunization Technical Advisory Groups (NITAGs) worldwide to inform decision-making on local vaccine administration strategies, as needed.

In collaboration with academic groups in South Africa and around the world, the Company has been evaluating the effectiveness of its COVID-19 vaccine across variants, now including the new and rapidly spreading Omicron variant. In addition, the Company is pursuing an Omicron-specific variant vaccine and will progress it as needed.

For more information on the Company’s multi-pronged approach to helping combat the pandemic, visit: www.jnj.com/covid-19.

Authorized Use
The Johnson & Johnson COVID-19 vaccine, also referred to as the Janssen COVID-19 Vaccine, is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

  • Primary vaccination regimen for the Janssen COVID-19 Vaccine is a single-dose (0.5 mL) administered to individuals 18 years of age and older.
  • A single Janssen COVID-19 Vaccine booster dose (0.5 mL) may be administered at least 2 months after the primary vaccination to individuals 18 years of age and older.
  • A single booster dose of the Janssen COVID-19 Vaccine (0.5 mL) may be administered to individuals 18 years of age and older as a heterologous booster dose following completion of primary vaccination with another authorized or approved COVID-19 vaccine. The dosing interval for the heterologous booster dose is the same as that authorized for a booster dose of the vaccine used for primary vaccination.

IMPORTANT SAFETY INFORMATION

WHAT SHOULD YOU MENTION TO YOUR VACCINATION PROVIDER BEFORE YOU GET THE JANSSEN COVID-19 VACCINE?
Tell the vaccination provider about all of your medical conditions, including if you:

  • have any allergies
  • have a fever
  • have a bleeding disorder or are on a blood thinner
  • are immunocompromised or are on a medicine that affects your immune system
  • are pregnant or plan to become pregnant
  • are breastfeeding
  • have received another COVID-19 vaccine
  • have ever fainted in association with an injection

WHO SHOULD NOT GET THE JANSSEN COVID-19 VACCINE?
You should not get the Janssen COVID-19 Vaccine if you:

  • had a severe allergic reaction after a previous dose of this vaccine
  • had a severe allergic reaction to any ingredient of this vaccine.

HOW IS THE JANSSEN COVID-19 VACCINE GIVEN?
The Janssen COVID-19 Vaccine will be given to you as an injection into the muscle.

Primary Vaccination: The Janssen COVID-19 Vaccine is administered as a single dose.

Booster Dose:

  • A single booster dose of the Janssen COVID-19 Vaccine may be administered at least two months after primary vaccination with the Janssen COVID-19 Vaccine.
  • A single booster dose of the Janssen COVID-19 Vaccine may be administered to individuals 18 years of age and older who have completed primary vaccination with a different authorized or approved COVID-19 vaccine. Please check with your health care provider regarding timing of the booster dose.

WHAT ARE THE RISKS OF THE JANSSEN COVID-19 VACCINE?
Side effects that have been reported with the Janssen COVID-19 Vaccine include:

  • Injection site reactions: pain, redness of the skin, and swelling.
  • General side effects: headache, feeling very tired, muscle aches, nausea, fever.
  • Swollen lymph nodes.
  • Blood clots.
  • Unusual feeling in the skin (such as tingling or a crawling feeling) (paresthesia), decreased feeling or sensitivity, especially in the skin (hypoesthesia).
  • Persistent ringing in the ears (tinnitus).
  • Diarrhea, vomiting.

Severe Allergic Reactions
There is a remote chance that the Janssen COVID-19 Vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the Janssen COVID-19 Vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination. Signs of a severe allergic reaction can include:

  • Difficulty breathing
  • Swelling of your face and throat
  • A fast heartbeat
  • A bad rash all over your body
  • Dizziness and weakness

Blood Clots with Low Levels of Platelets
Blood clots involving blood vessels in the brain, lungs, abdomen, and legs along with low levels of platelets (blood cells that help your body stop bleeding), have occurred in some people who have received the Janssen COVID-19 Vaccine. In people who developed these blood clots and low levels of platelets, symptoms began approximately one to two-weeks after vaccination. Reporting of these blood clots and low levels of platelets has been highest in females ages 18 through 49 years. The chance of having this occur is remote. You should seek medical attention right away if you have any of the following symptoms after receiving Janssen COVID-19 Vaccine:

  • Shortness of breath,
  • Chest pain,
  • Leg swelling,
  • Persistent abdominal pain,
  • Severe or persistent headaches or blurred vision,
  • Easy bruising or tiny blood spots under the skin beyond the site of the injection.

These may not be all the possible side effects of the Janssen COVID-19 Vaccine. Serious and unexpected effects may occur. The Janssen COVID-19 Vaccine is still being studied in clinical trials.

Guillain Barré Syndrome
Guillain Barré syndrome (a neurological disorder in which the body’s immune system damages nerve cells, causing muscle weakness and sometimes paralysis) has occurred in some people who have received the Janssen COVID-19 Vaccine. In most of these people, symptoms began within 42 days following receipt of the Janssen COVID-19 Vaccine. The chance of having this occur is very low. You should seek medical attention right away if you develop any of the following symptoms after receiving the Janssen COVID-19 Vaccine:

  • Weakness or tingling sensations, especially in the legs or arms, that’s worsening and spreading to other parts of the body.
  • Difficulty walking.
  • Difficulty with facial movements, including speaking, chewing, or swallowing.
  • Double vision or inability to move eyes.
  • Difficulty with bladder control or bowel function.

WHAT SHOULD I DO ABOUT SIDE EFFECTS?
If you experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital.

Call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away.

Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html. Please include “Janssen COVID-19 Vaccine EUA” in the first line of box #18 of the report form. In addition, you can report side effects to Janssen Biotech Inc. at 1-800-565-4008.

CAN I RECEIVE THE JANSSEN COVID-19 VACCINE AT THE SAME TIME AS OTHER VACCINES?
Data have not yet been submitted to FDA on administration of the Janssen COVID-19 Vaccine at the same time as other vaccines. If you are considering receiving the Janssen COVID-19 Vaccine with other vaccines, discuss your options with your healthcare provider.

Please read Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including full EUA Prescribing Information available at: www.JanssenCOVID19Vaccine.com/EUA-factsheet.

About Johnson & Johnson
At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity. Learn more at www.jnj.com. Follow us at @JNJNews.

About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension. Learn more at www.janssen.com. Follow us at @JanssenGlobal.



Cautions Concerning Forward-Looking Statements


This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding development, manufacture and distribution of the Johnson & Johnson COVID-19 vaccine. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Janssen Pharmaceutical Companies, and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 3, 2021, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.govwww.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

 

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SOURCE Johnson & Johnson

Sorrento Announces Publication of a Series of Novel SARS-CoV-2 Main Protease (MPRO) Inhibitors for Potential Treatment of COVID-19 Patients Infected With SARS-CoV-2 Variants Of Concern, Including Omicron

  • A representative of novel MPro inhibitor series, MPI8, dually inhibits MPro and cathepsin L, a key viral entry enzyme, with high potency and selectivity.
  • Other analogs of the series have been evaluated by Sorrento to develop an oral antiviral drug for treatment of patients infected with existing and emerging SARS-CoV-2 variants of concern, including Omicron.
  • A promising candidate of the series with unique features distinguished from SARS-CoV-2 MPro inhibitors published by others has been systematically evaluated and advanced to late stage of pre-clinical phase.

SAN DIEGO, Dec. 05, 2021 (GLOBE NEWSWIRE) — Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) today announced the peer-reviewed publication of a series of novel SARS-CoV-2 MPro inhibitors with potent activities for both MPro and cathepsin L, a key host enzyme for SARS-CoV-2 entry into host cells, authored by Dr. Wenshe Ray Liu, professor at Texas A&M University.

The full manuscript is available at: https://pubmed.ncbi.nlm.nih.gov/34242492/

SARS-CoV-2 main protease (MPro) is a key enzyme for the viral life cycle including virus entry, replication and packaging. MPro is highly conserved in all discovered SARS CoV-2 variants and is identified as a critical target for developing broad-spectrum antiviral drugs. In addition, experimental evidence has shown that certain host proteases prime the SARS-CoV-2 spike protein for viral packaging, interactions with ACE2, and viral entry into the host. These include two serine proteases, furin and transmembrane protease serine 2 (TMPRSS2) and a cysteine protease cathepsin L. Small molecule medications that inhibit furin, TMPRSS2 and cathepsin L have shown efficacy in inhibiting SARS-CoV-2 replication. In the publication, a representative analog of the series, MPI8, demonstrated dual inhibition of MPro and cathepsin L with high potency and selectivity (IC50 values for MPro and cathepsin L are 105 nM and 1.2 nM, respectively). Sorrento has collaborated with Professor Liu’s lab at Texas A&M University to evaluate analogs in the series to develop an oral anti-COVID drug. A promising analog with features distinguished from current reported SARS-CoV-2 MPro inhibitors has been systematically evaluated and advanced to a late stage of pre-clinical phase. “We are pleased to work with Prof. Liu’s group at Texas A&M University to develop a more effective oral MPro inhibitor to meet the urgent need for treatment of COVID-19 patients infected with existing and emerging variants. The oral MPro inhibitor together with Sorrento’s other ongoing therapeutic intervention approaches reflect our efforts to create a ‘mutation-agnostic’ global anti-COVID strategy to combat COVID-19 variants of concern, including the emerging Omicron variant,” stated Dr. Henry Ji, Chairman and CEO of Sorrento.

“As a selective inhibitor to both SARS-CoV-2 MPro and cathepsin L that is key to SARS-CoV-2 entry into the human host cell, MPI8 exerts improved potency to inhibit SARS-CoV-2. So far it is potentially one of the most potent antivirals that have been developed to treat COVID-19,” stated Dr. Wenshe Ray Liu, Gradipore Chair in the Department of Chemistry at Texas A&M University.

About Sorrento Therapeutics, Inc.

Sorrento is a clinical and commercial stage biopharmaceutical company developing new therapies to treat cancer, pain (non-opioid treatments), autoimmune disease 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”), immuno-cellular therapies (“DAR-T™”), antibody-drug conjugates (“ADCs”), and oncolytic virus (“Seprehvec™”). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including Abivertinib, COVIGUARD™, COVI-AMG™, COVISHIELD™, 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 Sorrento’s plans with respect to its preclinical MPro inhibitor product candidates, including MPI8; the antiviral properties of Sorrento’s MPro inhibitor product candidates, including MPI8, and the potential advantage the MPro inhibitors offer against SARS-CoV-2 and its variants of concern, including the Omicron variant; Sorrento’s plans to develop the MPro inhibitors to address COVID-19; and Sorrento’s plans to address COVID-19 variants of concern with a combination of therapeutic intervention approaches, including MPro inhibitors. 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 technologies and prospects, including, but not limited to risks related to seeking regulatory approval for MPro inhibitors, including MPI8, against SARS-CoV-2 and its variants of concern; 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 antibody product candidate 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.


Media and Investor Relations Contact


Dorman Followwill
Email: [email protected]

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

G-MAB™, DAR-T™, SOFUSA™, COVIGUARD™, COVI-AMG™, COVISHIELD™, 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.



AVANGRID Files Defamation and Tortious Interference Lawsuit Against Security Limits for Using False Allegations to Seek to Extort the Company

AVANGRID Files Defamation and Tortious Interference Lawsuit Against Security Limits for Using False Allegations to Seek to Extort the Company

ORANGE, Conn.–(BUSINESS WIRE)–
Today, AVANGRID, Inc. (NYSE:AGR), a leading sustainable energy company, filed suit in New Mexico against Security Limits, Inc. and its owner and CEO Paulo Silva for defamation and tortious interference. In the suit, AVANGRID lays out how Silva, a disgruntled former AVANGRID Networks sub-contractor, interjected himself into the merger review process between AVANGRID and PNM Resources in New Mexico after AVANGRID rebuked his threats to do so if AVANGRID would not agree to enter into a new contract with him.

Security Limits’ Silva is using the New Mexico Public Regulation Commission (PRC) merger review process as part of an effort to extort AVANGRID. His claims are being echoed by the lone opponent to the merger, New Energy Economy (NEE), in efforts to have the merger be denied by the PRC.

Despite his criticisms of AVANGRID, Silva has touted and continues to tout his affiliation with AVANGRID on his LinkedIn page https://www.linkedin.com/in/paulosilva-cybersecurity/.

Under New Mexico Statutes Section 30-16-9 (2020), Extortion is defined, in relevant part, as follows:

Extortion consists of the communication or transmission of any threat to another by any means whatsoever with intent thereby to wrongfully obtain anything of value or to wrongfully compel the person threatened to do or refrain from doing any act against his will. Any of the following acts shall be sufficient to constitute a threat under this section:

  • a threat to do an unlawful injury to the person or property of the person threatened or of another;
  • a threat to accuse the person threatened, or another, of any crime;
  • a threat to expose, or impute to the person threatened, or another, any deformity or disgrace;

Whoever commits extortion is guilty of a third-degree felony.

“At the PRC public comment in August, while decrying the purported corruption within Iberdrola and AVANGRID and making false, outrageous statements, Silva was just five days earlier desperately trying to secure additional contracts with AVANGRID and its companies,” said Robert Kump, AVANGRID President and Deputy CEO.

According to AVANGRID’s Senior Vice President and General Counsel R. Scott Mahoney, “AVANGRID will vigorously defend itself against the meritless allegations and claims made by Security Limits and echoed by NEE.” Mahoney added, “In fact, AVANGRID has previously reviewed unsubstantiated allegations made by Silva’s company Security Limits and sent it a cease-and-desist letter.”

AVANGRID is pursuing all legal remedies against Security Limits, Silva and anyone that has aided him.

About AVANGRID: AVANGRID, Inc. (NYSE: AGR) aspires to be the leading sustainable energy company in the United States. Headquartered in Orange, CT, with approximately $39 billion in assets and operations in 24 U.S. states, AVANGRID has two primary lines of business: Avangrid Networks and Avangrid Renewables. Avangrid Networks owns and operates eight electric and natural gas utilities, serving more than 3.3 million customers in New York and New England. Avangrid Renewables owns and operates a portfolio of renewable energy generation facilities across the United States. AVANGRID employs approximately 7,000 people and has been recognized by Forbes and Just Capital as one of the 2021 JUST 100 companies – a list of America’s best corporate citizens – and was ranked number one within the utility sector for its commitment to the environment and the communities it serves. The company supports the U.N.’s Sustainable Development Goals and was named among the World’s Most Ethical Companies in 2021 for the third consecutive year by the Ethisphere Institute. For more information, visit www.avangrid.com.

Zsoka McDonald (203) 997-6892

or [email protected]

Joanie Griffin (505) 261-4444 or

[email protected]

KEYWORDS: United States North America New Mexico Connecticut

INDUSTRY KEYWORDS: Alternative Energy Energy Utilities

MEDIA:

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UPDATE: Lightspeed Commerce Inc. Investors with Substantial Losses Have Opportunity to Lead Class Action Lawsuit – LSPD

PR Newswire

SAN DIEGO, Dec. 4, 2021 /PRNewswire/ — Robbins Geller Rudman & Dowd LLP announces that purchasers or acquirers of Lightspeed Commerce Inc. (NYSE: LSPD) securities between September 11, 2020 and November 3, 2021, inclusive (the “Class Period”) have until January 18, 2022 to seek appointment as lead plaintiff in the Lightspeed Commerce class action lawsuit.  The first-filed complaint – captioned Nath v. Lightspeed Commerce Inc., No. 21-cv-06365 (E.D.N.Y.) – was commenced on November 16, 2021 and charges Lightspeed Commerce along with certain of its top executives with violations of the Securities Exchange Act of 1934.  A similar lawsuit – Pappas v. Lightspeed Commerce Inc., No. 21-cv-10304 (S.D.N.Y.) – is also pending in the Southern District of New York.

If you wish to serve as lead plaintiff of the

Lightspeed Commerce class action lawsuit, please provide your information by clicking here.  You can also contact attorney Mary K. Blasy

of Robbins Geller by calling 800/449-4900 or via e-mail at [email protected].  Lead plaintiff motions for the

Lightspeed
Commerce class action lawsuit must be filed with the court no later than January 18, 2022.

CASE ALLEGATIONS: Lightspeed Commerce provides commerce enabling software as a service platform for small and midsize businesses, retailers, restaurants, and golf course operators in Canada, the United States, Germany, Australia, and internationally.  On September 15, 2020, Lightspeed Commerce completed its U.S. initial public offering (“IPO”) and listing on the New York Stock Exchange of nearly 11 million shares of its common stock, receiving proceeds of more than $332 million.  A secondary sale of more than 2 million shares by certain selling shareholders was also completed that same day for gross proceeds of more than $65 million

The Lightspeed Commerce class action lawsuit alleges that, throughout the Class Period, defendants made false and misleading statements and failed to disclose that: (i) Lightspeed Commerce had overstated its pre-IPO business metrics and financial prospects by overstating its true customer count by 85%; (ii) Lightspeed Commerce had overstated its pre-IPO business metrics and financial prospects by overstating its true gross transaction volume (“GTV”) – a payment volume metric that a former employee describes as “smoke and mirrors” – by 10%; (iii) Lightspeed Commerce was then overstating its business metrics and financial prospects by concealing declining organic growth and business deterioration; (iv) Lightspeed Commerce was also overstating its business metrics and financial prospects by claiming that its Average Revenue Per User (“ARPU”) was increasing; (v) Lightspeed Commerce had undertaken an acquisition spree at escalating costs with no clear path to profitability, while its management pursued aggressive revenue reporting practices; and (vi) defendants had been operating Lightspeed Commerce with defective internal controls and ineffective oversight of its accounting practices by its outside audit firm.

On September 29, 2021, Spruce Point Capital Management published a report regarding Lightspeed Commerce and also issued a press release summarizing its findings.  The release stated, among other things, that “[e]vidence shows that Lightspeed massively inflated its business pre-IPO, overstating its customer count by 85% and [GTV] by 10%” – a payment volume metric that a former employee described as “‘smoke and mirrors'”; that there was “[e]vidence of declining organic growth and business deterioration through Lightspeed’s IPO, despite management’s claims that [ARPU] is increasing; and that Lightspeed Commerce’s [r]ecent acquisition spree has come at escalating costs with no clear path to profitability, while management pursues aggressive revenue reporting practices.”  On this news, Lightspeed Commerce’s stock price fell by more than 12%.

Then, on November 4, 2021, Lightspeed Commerce issued a press release announcing its second quarter 2022 financial results for the interim period ended September 30, 2021.  While Lightspeed Commerce’s second quarter 2022 revenue grew 193% on a year-over-year basis to $133.2 million, a full half of that revenue came from new business acquisitions, while organic revenue in its core segments – subscriptions and transcriptions – grew a mere 58% – well below the 78% growth Lightspeed Commerce had just touted on November 3rd in disputing the Spruce Point Capital report findings.  More critically, Lightspeed Commerce’s guidance for the rest of its fiscal year 2022 (“FY22”) demonstrated that its earlier revenue growth had indeed been driven primarily by the acquisitions as the Spruce Point Capital report had charged, and that those tailwinds were now rapidly fading.  For its third quarter 2022, Lightspeed Commerce was now only forecasting revenues in the range of $140 million to $145 million – or a paltry 7% sequential revenue growth.  And for FY22, Lightspeed Commerce was now only guiding for revenues of $520 million to $535 million, implying no sequential growth whatsoever in Lightspeed Commerce’s fourth quarter of 2022.  On this news, Lightspeed Commerce’s stock price further fell by nearly 28%, further damaging investors.

THE LEAD PLAINTIFF PROCESS: The Private Securities Litigation Reform Act of 1995 permits any investor who purchased Lightspeed Commerce securities during the Class Period to seek appointment as lead plaintiff in the Lightspeed Commerce class action lawsuit.  A lead plaintiff is generally the movant with the greatest financial interest in the relief sought by the putative class who is also typical and adequate of the putative class.  A lead plaintiff acts on behalf of all other class members in directing the Lightspeed Commerce class action lawsuit.  The lead plaintiff can select a law firm of its choice to litigate the Lightspeed Commerce class action lawsuit.  An investor’s ability to share in any potential future recovery of the Lightspeed Commerce class action lawsuit is not dependent upon serving as lead plaintiff. 

ABOUT ROBBINS GELLER RUDMAN & DOWD LLP: With 200 lawyers in 9 offices nationwide, Robbins Geller Rudman & Dowd LLP is the largest U.S. law firm representing investors in securities class actions.  Robbins Geller attorneys have obtained many of the largest shareholder recoveries in history, including the largest securities class action recovery ever – $7.2 billion – in In re Enron Corp. Sec. Litig.  The 2020 ISS Securities Class Action Services Top 50 Report ranked Robbins Geller first for recovering $1.6 billion for investors last year, more than double the amount recovered by any other securities plaintiffs’ firm.  Please visit http://www.rgrdlaw.com for more information. 

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Contact:

Robbins Geller Rudman & Dowd LLP

655 W. Broadway, San Diego, CA  92101

Mary K. Blasy, 800-449-4900


[email protected] 

https://www.linkedin.com/company/rgrdlaw 
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https://www.facebook.com/rgrdlaw

Cision View original content:https://www.prnewswire.com/news-releases/update-lightspeed-commerce-inc-investors-with-substantial-losses-have-opportunity-to-lead-class-action-lawsuit–lspd-301437441.html

SOURCE Robbins Geller Rudman & Dowd LLP

DEADLINE APPROACHING: StoneCo Ltd. Investors with Substantial Losses Have Opportunity to Lead Class Action Lawsuit – STNE

PR Newswire

SAN DIEGO, Dec. 4, 2021 /PRNewswire/ — Robbins Geller Rudman & Dowd LLP announces that purchasers of StoneCo Ltd. (NASDAQ: STNE) securities between March 11, 2021 and November 16, 2021, both dates inclusive (the “Class Period”) have until January 18, 2022 to seek appointment in Ray v. StoneCo Ltd., No. 21-cv-09620 (S.D.N.Y.).  Commenced on November 19, 2021, the StoneCo class action lawsuit charges StoneCo and certain of its top executives with violations of the Securities Exchange Act of 1934. 

If you wish to serve as lead plaintiff of the StoneCo class action lawsuit, please provide your information by clicking here.  You can also contact attorney J.C. Sanchez of Robbins Geller by calling 800/449-4900 or via e-mail at [email protected].  Lead plaintiff motions for the StoneCo class action lawsuit must be filed with the court no later than January 18, 2022.

CASE ALLEGATIONS: StoneCo is a provider of financial technology solutions that allows merchants and other vendors to conduct electronic commerce across in-store, online, and mobile channels, primarily in Brazil.

The StoneCo class action lawsuit alleges that, throughout the Class Period, defendants made false and misleading statements and failed to disclose that: (i) StoneCo was experiencing difficulties in implementing its credit product; (ii) StoneCo faced significant risks via its point-of-sale vendor, PAX Global Technology Ltd.; (iii) as a result, StoneCo’s financial results would be adversely impacted; and (iv) consequently, defendants’ positive statements about StoneCo’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

On August 30, 2021, StoneCo reported an 8.1% year-over-year decrease in revenue “mainly due to adjustments in credit fair value and significantly lower credit disbursements.”  StoneCo further reported that it had “implemented some prudent actions, like temporarily stopping the disbursement of credit and increasing coverage for potential future losses, which impacted [StoneCo’s] reported results for the quarter.”  On this news, StoneCo’s share price fell.

Then, on October 26, 2021, PAX Global Technology Ltd.’s Florida offices were raided by the U.S. Federal Bureau of Investigation, the Department of Homeland Security, and several other agencies as part of a federal investigation.  As a Viceroy Research report on October 27, 2021 pointed out, StoneCo states that PAX “is no longer [its] sole provider of POS services, [but StoneCo is] still substantially dependent on it to manufacture and assemble a substantial amount of [its] POS devices.”  Moreover, another company replaced its PAX terminals “because it did not receive satisfactory answers from PAX regarding its POS devices connecting to websites not listed in their supplied documentation.”  On this news, StoneCo’s share price fell an additional 7%.

Finally, on November 16, 2021, StoneCo announced that it would “start retesting our original [credit] product, which is short-term loans, between the fourth quarter of ’21 and the first quarter of ’22.”  StoneCo could not provide specific guidance about when credit volumes would return to levels before StoneCo had halted origination of credit.  On this news, StoneCo’s share price fell another 34%, further damaging investors.

THE LEAD PLAINTIFF PROCESS: The Private Securities Litigation Reform Act of 1995 permits any investor who purchased StoneCo securities during the Class Period to seek appointment as lead plaintiff in the StoneCo class action lawsuit.  A lead plaintiff is generally the movant with the greatest financial interest in the relief sought by the putative class who is also typical and adequate of the putative class.  A lead plaintiff acts on behalf of all other class members in directing the StoneCo class action lawsuit.  The lead plaintiff can select a law firm of its choice to litigate the StoneCo class action lawsuit.  An investor’s ability to share in any potential future recovery of the StoneCo class action lawsuit is not dependent upon serving as lead plaintiff. 

ABOUT ROBBINS GELLER RUDMAN & DOWD LLP: With 200 lawyers in 9 offices nationwide, Robbins Geller Rudman & Dowd LLP is the largest U.S. law firm representing investors in securities class actions.  Robbins Geller attorneys have obtained many of the largest shareholder recoveries in history, including the largest securities class action recovery ever – $7.2 billion – in In re Enron Corp. Sec. Litig.  The 2020 ISS Securities Class Action Services Top 50 Report ranked Robbins Geller first for recovering $1.6 billion for investors last year, more than double the amount recovered by any other securities plaintiffs’ firm.  Please visit http://www.rgrdlaw.com for more information. 

Attorney advertising.
Past results do not guarantee future outcomes.
Services may be performed by attorneys in any of our offices.

Contact:

Robbins Geller Rudman & Dowd LLP
655 W. Broadway, San Diego, CA  92101
J.C. Sanchez, 800-449-4900
[email protected]

https://www.linkedin.com/company/rgrdlaw

https://twitter.com/rgrdlaw

https://www.facebook.com/rgrdlaw

Cision View original content:https://www.prnewswire.com/news-releases/deadline-approaching-stoneco-ltd-investors-with-substantial-losses-have-opportunity-to-lead-class-action-lawsuit–stne-301437424.html

SOURCE Robbins Geller Rudman & Dowd LLP