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SHAREHOLDER ALERT: The Gross Law Firm Notifies Shareholders of Vertex Energy, Inc. of a Class Action Lawsuit and a Lead Plaintiff Deadline of June 12, 2023 – (NASDAQ: VTNR)

NEW YORK, May 11, 2023 (GLOBE NEWSWIRE) — The Gross Law Firm issues the following notice to shareholders of Vertex Energy, Inc..

Shareholders who purchased shares of VTNR during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery.

CONTACT US HERE:

https://securitiesclasslaw.com/securities/vertex-energy-inc-loss-submission-form/?id=39216&from=3

CLASS PERIOD: April 1, 2022 to August 8, 2022

ALLEGATIONS: The complaint alleges that during the class period, Defendants issued materially false and/or misleading statements and/or failed to disclose that: (a) prior to the acquisition of the oil refinery in Mobile, Alabama, defendants had entered into inventory and crack spread hedging derivatives that significantly capped the profit margins on 50% of the Mobile refinery’s expected output over the period April 1, 2022 to September 30, 2022, affecting over 6.5 million barrels of refined fuel output. These hedges severely limited Vertex’s ability to capitalize on the record-high crack spreads that existed at the time of the acquisition and resulted in over $90 million in losses in the second quarter of fiscal year 2022; (b) prior to the acquisition of the Mobile refinery, defendants had entered into an inventory intermediation agreement with the investment bank Macquarie Group, whereby Macquarie purchased (from third parties), owned, and sold (to Vertex) all crude oil inventory to be used at the Mobile refinery and also purchased (from Vertex), owned, and sold (to third parties) all refined fuel inventory produced at the Mobile refinery. The strict terms of the arrangement, including requiring Vertex to purchase hedges to protect Macquarie’s position in holding the crude and refined inventory, combined with the fact that the oil market was in a state of backwardation in early 2022, resulted in Vertex incurring significant fees and inventory losses. The losses, which began as of the April 1, 2022 acquisition date, totaled $23 million during the second quarter of fiscal year 2022; (c) prior to the acquisition of the Mobile refinery, defendants had entered into an inventory purchase agreement with Shell Oil as part of the Mobile acquisition agreement. Vertex had anticipated purchasing approximately $100 million of crude oil and refined fuel inventory. Immediately prior to the closing of the acquisition, Vertex learned that pursuant to the terms of the purchase agreement, it would be required to purchase substantially more inventory from Shell Oil, totaling $164 million. Due to the state of backwardation in the oil market, Vertex was forced to pay Shell Oil above-market prices for the additional crude oil inventory. The additional Shell Oil inventory purchase triggered $13.3 million in inventory losses at or around the time of the acquisition; (d) immediately following the acquisition of the Mobile refinery, Vertex experienced production issues that caused significant shortfalls in refined fuel volumes. The production issues resulted in $8 million of lost profits during the second quarter of fiscal year 2022; (e) following the acquisition of the Mobile refinery, defendants overstated the purported profit margins that could be achieved at the refinery. Defendants represented that the “3-2-1 crack spread” was the appropriate benchmark for the Mobile refinery; however it was later revealed that the “2-1-1 crack spread,” which resulted in lower profits per barrel of production, was the more accurate profit benchmark for the Mobile refinery; and (f) as a result of the above misrepresentations and concealed facts, the Mobile refinery did not “generate[] strong EBITDA]” “[d]uring the first 30 days of operations,” and the Mobile refinery transition was not “seamless.”

DEADLINE: June 12, 2023 Shareholders should not delay in registering for this class action. Register your information here: https://securitiesclasslaw.com/securities/vertex-energy-inc-loss-submission-form/?id=39216&from=3

NEXT STEPS FOR SHAREHOLDERS: Once you register as a shareholder who purchased shares of VTNR during the timeframe listed above, you will be enrolled in a portfolio monitoring software to provide you with status updates throughout the lifecycle of the case. The deadline to seek to be a lead plaintiff is June 12, 2023. There is no cost or obligation to you to participate in this case.

WHY GROSS LAW FIRM? The Gross Law Firm is a nationally recognized class action law firm, and our mission is to protect the rights of all investors who have suffered as a result of deceit, fraud, and illegal business practices. The Gross Law Firm is committed to ensuring that companies adhere to responsible business practices and engage in good corporate citizenship. The firm seeks recovery on behalf of investors who incurred losses when false and/or misleading statements or the omission of material information by a company lead to artificial inflation of the company’s stock. Attorney advertising. Prior results do not guarantee similar outcomes.

CONTACT:

The Gross Law Firm
15 West 38th Street, 12th floor
New York, NY, 10018
Email: [email protected]
Phone: (646) 453-8903



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2seventy bio Announces Additional Data from KarMMa Studies of Abecma (idecabtagene vicleucel) at ASCO 2023 and EHA 2023

2seventy bio Announces Additional Data from KarMMa Studies of Abecma (idecabtagene vicleucel) at ASCO 2023 and EHA 2023

Subgroup analysis of outcomes for patients with high-risk relapsed and refractory multiple myeloma (RRMM) from the pivotal Phase 3 KarMMa-3 trial accepted for oral presentation at EHA

Analysis from KarMMa-3 study of health-related quality of life in patients who received Abecma will be presented at ASCO

Breadth of data underscores 2seventy bio’s commitment to meeting the individual needs of patients with RRMM or newly diagnosed multiple myeloma

CAMBRIDGE, Mass.–(BUSINESS WIRE)–2seventy bio, Inc. (Nasdaq: TSVT) today announced the presentation of four abstracts at theAmerican Society of Clinical Oncology (ASCO) Annual Meeting taking place from June 2-6, 2023 in Chicago, Illinois and six abstracts at the European Hematology Association (EHA) Congress, taking place in Frankfurt, Germany from June 8-11, 2023.

The presentations will highlight clinical and correlative data from the KarMMa-2 and KarMMa-3 clinical trials evaluating Abecma (idecabtagene vicleucel)in patients with relapsed and/or refractory multiple myeloma (RRMM) or newly diagnosedmultiple myeloma.

“These data highlight the growing body of evidence that further support the value ofAbecma across various subgroups of patients with triple-class-exposed relapsed and/or refractory multiple myeloma, who, despite recent advancements, still need more effective treatment options sooner,” said Steve Bernstein, M.D., chief medical officer, 2seventy bio. “We are pleased to share new findings of Abecma from KarMMa-3, including an analysis of health-related quality of life in patients with RRMM, a subgroup analysis of outcomes for patients with high-risk disease, and a biomarker correlative analysis of response to Abecma. We remain committed to bringing this innovative CAR T cell therapy to patients earlier in their treatment course.”

Key abstracts include:

  • Subgroup analysis of outcomes with Abecma in high-risk patient groups from the Phase 3 KarMMa-3 clinical study in patients with triple-class exposed RRMM.

  • Additional analysis of outcomes by number of prior lines of therapy from the KarMMa-3 clinical trial showcasing the use of Abecma in patients who received two to four prior lines of therapy.

  • Patient-reported outcomes from the pivotal Phase 3 KarMMa-3 trial in patients with triple-class exposed RRMM treated with Abecma versus standard regimens.

The full list of accepted data abstracts include:

ASCO 2023 Presentation Details

Poster Presentation [#8031]: Baseline and early post-infusion biomarkers associated with optimal response to idecabtagene vicleucel (ide-cel) in the KarMMa-3 study of triple-class–exposed (TCE) relapsed and refractory multiple myeloma (RRMM)

Presenting Author: Julia Piasecki, Bristol Myers Squibb

Date/Time: Monday, June 5, 2023, 8:00 – 11:00 a.m. CDT

Poster Presentation [#8032]: Health related quality of life (HRQoL) in patients with triple-class-exposed relapsed/refractory multiple myeloma (TCE RRMM) treated with idecabtagene vicleucel (ide-cel) versus standard regimens: patient-reported outcomes (PROs) from KarMMa-3 phase 3 randomized controlled trial (RCT)

Presenting Author: Michel Delforge, M.D., Ph.D., University of Leuven, Leuven, Belgium

Date/Time: Monday, June 5, 2023, 8:00 – 11:00 a.m. CDT

Poster Presentation [#8035]: Tumor-intrinsic features associated with progression-free survival (PFS) in patients (pts) with relapsed and refractory multiple myeloma (RRMM) treated with idecabtagene vicleucel (ide-cel)

Presenting Author: Nicholas Stong, Ph.D., Bristol Myers Squibb

Date/Time: Monday, June 5, 2023, 8:00 – 11:00 a.m. CDT

Poster Presentation [e-pub only]: Baseline characteristics identifying patients (pts) with multiple myeloma (MM) treated with idecabtagene vicleucel (ide-cel; bb2121) who are at risk for severe/refractory inflammatory adverse events (iAEs)

Presenting Author: Afshin Mashadi-Hossein, Bristol Myers Squibb

Date/Time: N/A

EHA 2023 Presentation Details

Oral Presentation [#S195]: Idecabtagene vicleucel (ide-cel) vs standard regimens in patients with triple-class–exposed (TCE) relapsed and refractory multiple myeloma (RRMM): a KarMMa-3 analysis in high-risk subgroups

Presenting Author: Krina Patel, M.D., MD Anderson Cancer Center, University of Texas, Houston, Texas

Date/Time: Saturday, June 10, 2023,4:30 – 5:45 p.m. CEST

Poster Presentation [#P801]: Baseline and early post-infusion biomarkers associated with optimal response to idecabtagene vicleucel (ide-cel) in KarMMa-3 study of triple class exposed relapsed and refractory multiple myeloma

Presenting Author: Marc S. Raab, M.D., Heidelberg University Hospital, Heidelberg, Germany

Date/Time: Friday,June 9, 2023, 6:00 – 7:00 p.m. CEST

Poster Presentation [#P809]: Baseline characteristics identifying patients with multiple myeloma treated with idecabtagene vicleucel (ide-cel; bb2121) who are at risk for severe/refractory inflammatory adverse events

Presenting Author: Yi Lin, M.D., Ph.D., Mayo Clinic, Rochester, Minn.

Date/Time: Friday, June 9, 2023, 6:00 – 7:00 p.m. CEST

Poster Presentation [#P866]: Idecabtagene vicleucel (ide-cel) vs standard regimens in patients with triple-class-exposed (TCE) relapsed and refractory multiple myeloma (RRMM): KarMMa-3 subgroup analysis by prior lines of therapy

Presenting Author: Salomon Manier, Centre Hospitalier Universitaire de Lille, Université de Lille, Lille, France

Date/Time: Friday, June 9, 2023, 6:00 – 7:00 p.m. CEST

Poster Presentation [#P871]: Idecabtagene vicleucel (ide-cel) in patients with an inadequate response to frontline autologous stem cell transplantation (ASCT): results from KarMMa-2 cohort 2c

Presenting Author: Melissa Alsina, M.D., Moffitt Cancer Center, Tampa, Fla.

Date/Time: Friday, June 9, 2023, 6:00 – 7:00 p.m. CEST

Poster Presentation [#P905]: Patient reported outcomes in triple class exposed, relapsed/refractory multiple myeloma (TCE RRMM) patients in KarMMa-3 trial (phase 3 RCT): idecabtagene vicleucel (ide-cel) versus standard regimens

Presenting Author: Michel Delforge, M.D., Ph.D., University of Leuven, Leuven, Belgium

Date/Time: Friday, June 9, 2023, 6:00 – 7:00 p.m. CEST

About KarMMa-3

KarMMa-3 (NCT03651128) is a pivotal, Phase 3, open-label, global, randomized, controlled trial evaluating Abecma compared to standard regimens in patients with relapsed and refractory multiple myeloma who have received two to four prior lines of treatment, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody, and were refractory to the last treatment regimen. Patients were randomized to receive Abecma or standard regimens that consisted of combinations that included daratumumab, pomalidomide, and dexamethasone (DPd), daratumumab, bortezomib, and dexamethasone (DVd), ixazomib, lenalidomide, and dexamethasone (IRd), carfilzomib and dexamethasone (Kd) or elotuzumab, pomalidomide and dexamethasone (EPd) chosen based on their most recent treatment regimen and investigator discretion. The primary endpoint evaluated in this study is progression-free survival, defined as time from randomization to the first documentation of progressive disease or death due to any cause, whichever occurs first. Key secondary endpoints include overall response rate and overall survival.

About Abecma

Abecma recognizes and binds to BCMA on the surface of multiple myeloma cells leading to CAR T cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells. Abecma is being jointly developed and commercialized in the U.S. as part of a Co-Development, Co-Promotion, and Profit Share Agreement between Bristol Myers Squibb and 2seventy bio.

The companies’ broad clinical development program for Abecma includes clinical studies (KarMMa-2, KarMMa-3, KarMMa-9) in earlier lines of treatment for patients with multiple myeloma. For more information visit clinicaltrials.gov.

Indication

ABECMA (idecabtagene vicleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

Important Safety Information

BOX WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, AND PROLONGED CYTOPENIA

  • Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with ABECMA. Do not administer ABECMA to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.

  • Neurologic Toxicities, which may be severe or life-threatening, occurred following treatment with ABECMA, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with ABECMA. Provide supportive care and/or corticosteroids as needed.

  • Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS) including fatal and life-threatening reactions, occurred in patients following treatment with ABECMA. HLH/MAS can occur with CRS or neurologic toxicities.

  • Prolonged Cytopenia with bleeding and infection, including fatal outcomes following stem cell transplantation for hematopoietic recovery, occurred following treatment with ABECMA.

  • ABECMA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ABECMA REMS.

WARNINGS AND PRECAUTIONS:

Cytokine Release Syndrome (CRS): CRS, including fatal or life-threatening reactions, occurred following treatment with ABECMA in 85% (108/127) of patients. Grade 3 or higher CRS occurred in 9% (12/127) of patients, with Grade 5 CRS reported in one (0.8%) patient. The median time to onset of CRS, any grade, was 1 day (range: 1 – 23 days) and the median duration of CRS was 7 days (range: 1 – 63 days). The most common manifestations included pyrexia, hypotension, tachycardia, chills, hypoxia, fatigue, and headache. Grade 3 or higher events that may be associated with CRS include hypotension, hypoxia, hyperbilirubinemia, hypofibrinogenemia, acute respiratory distress syndrome (ARDS), atrial fibrillation, hepatocellular injury, metabolic acidosis, pulmonary edema, multiple organ dysfunction syndrome, and HLH/MAS.

Identify CRS based on clinical presentation. Evaluate for and treat other causes of fever, hypoxia, and hypotension. CRS has been reported to be associated with findings of HLH/MAS, and the physiology of the syndromes may overlap. In patients with progressive symptoms of CRS or refractory CRS despite treatment, evaluate for evidence of HLH/MAS.

Fifty four percent (68/127) of patients received tocilizumab (single dose: 35%; more than 1 dose: 18%). Overall, 15% (19/127) of patients received at least 1 dose of corticosteroids for treatment of CRS. All patients that received corticosteroids for CRS received tocilizumab. Ensure that a minimum of 2 doses of tocilizumab are available prior to infusion of ABECMA.

Monitor patients at least daily for 7 days following ABECMA infusion at the REMS-certified healthcare facility for signs or symptoms of CRS and monitor patients for signs or symptoms of CRS for at least 4 weeks after ABECMA infusion. At the first sign of CRS, institute treatment with supportive care, tocilizumab and/or corticosteroids as indicated.

Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time.

Neurologic Toxicities: Neurologic toxicities, which may be severe or life-threatening, occurred following treatment with ABECMA, including concurrently with CRS, after CRS resolution, or in the absence of CRS. CAR T cell-associated neurotoxicity occurred in 28% (36/127) of patients receiving ABECMA, including Grade 3 in 4% (5/127) of patients. One patient had ongoing Grade 2 neurotoxicity at the time of death. Two patients had ongoing Grade 1 tremor at the time of data cutoff. The median time to onset of neurotoxicity was 2 days (range: 1 – 42 days). CAR T cell-associated neurotoxicity resolved in 92% (33/36) of patients with a median duration of neurotoxicity was 5 days (range: 1 – 61 days). The median duration of neurotoxicity was 6 days (range: 1 – 578) in all patients including those with ongoing neurotoxicity at the time of death or data cut off. Thirty-four patients with neurotoxicity had CRS. Neurotoxicity had onset in 3 patients before, 29 patients during, and 2 patients after CRS. The rate of Grade 3 neurotoxicity was 8% in the 450 x 106 CAR+ T cell dose cohort and 1.4% in the 300 x 106 CAR+ T cell dose cohort. The most frequently reported (greater than or equal to 5%) manifestations of CAR T cell-associated neurotoxicity include encephalopathy (20%), tremor (9%), aphasia (7%), and delirium (6%). Grade 4 neurotoxicity and cerebral edema in 1 patient has been reported with ABECMA in another study in multiple myeloma. Grade 3 myelitis and Grade 3 parkinsonism have been reported after treatment with ABECMA in another study in multiple myeloma.

Monitor patients at least daily for 7 days following ABECMA infusion at the REMS-certified healthcare facility for signs and symptoms of neurologic toxicities. Rule out other causes of neurologic symptoms. Monitor patients for signs or symptoms of neurologic toxicities for at least 4 weeks after infusion and treat promptly. Neurologic toxicity should be managed with supportive care and/or corticosteroids as needed.

Counsel patients to seek immediate medical attention should signs or symptoms of neurologic toxicity occur at any time.

Hemophagocytic Lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS): HLH/MAS occurred in 4% (5/127) of patients receiving ABECMA. One patient developed fatal multi-organ HLH/MAS with CRS and another patient developed fatal bronchopulmonary aspergillosis with contributory HLH/MAS. Three cases of Grade 2 HLH/MAS resolved. All events of HLH/MAS had onset within 10 days of receiving ABECMA with a median onset of 7 days (range: 4 – 9 days) and occurred in the setting of ongoing or worsening CRS. Two patients with HLH/MAS had overlapping neurotoxicity. The manifestations of HLH/MAS include hypotension, hypoxia, multiple organ dysfunction, renal dysfunction, and cytopenia. HLH/MAS is a potentially life-threatening condition with a high mortality rate if not recognized early and treated. Treatment of HLH/MAS should be administered per institutional guidelines.

ABECMA REMS: Due to the risk of CRS and neurologic toxicities, ABECMA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ABECMA REMS. Further information is available at www.AbecmaREMS.com or 1-888-423-5436.

Hypersensitivity Reactions: Allergic reactions may occur with the infusion of ABECMA. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO) in ABECMA.

Infections: ABECMA should not be administered to patients with active infections or inflammatory disorders. Severe, life-threatening, or fatal infections occurred in patients after ABECMA infusion. Infections (all grades) occurred in 70% of patients. Grade 3 or 4 infections occurred in 23% of patients. Overall, 4 patients had Grade 5 infections (3%); 2 patients (1.6%) had Grade 5 events of pneumonia, 1 patient (0.8%) had Grade 5 bronchopulmonary aspergillosis, and 1 patient (0.8%) had cytomegalovirus (CMV) pneumonia associated with Pneumocystis jirovecii. Monitor patients for signs and symptoms of infection before and after ABECMA infusion and treat appropriately. Administer prophylactic, preemptive, and/or therapeutic antimicrobials according to standard institutional guidelines.

Febrile neutropenia was observed in 16% (20/127) of patients after ABECMA infusion and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad spectrum antibiotics, fluids, and other supportive care as medically indicated.

Viral Reactivation: Cytomegalovirus (CMV) infection resulting in pneumonia and death has occurred following ABECMA administration. Monitor and treat for CMV reactivation in accordance with clinical guidelines. Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against plasma cells. Perform screening for CMV, HBV, hepatitis C virus (HCV), and human immunodeficiency virus (HIV) in accordance with clinical guidelines before collection of cells for manufacturing.

Prolonged Cytopenias: In the clinical study, 41% of patients (52/127) experienced prolonged Grade 3 or 4 neutropenia and 49% (62/127) experienced prolonged Grade 3 or 4 thrombocytopenia that had not resolved by Month 1 following ABECMA infusion. In 83% (43/52) of patients who recovered from Grade 3 or 4 neutropenia after Month 1, the median time to recovery from ABECMA infusion was 1.9 months. In 65% (40/62) of patients who recovered from Grade 3 or 4 thrombocytopenia, the median time to recovery was 2.1 months.

Three patients underwent stem cell therapy for hematopoietic reconstitution due to prolonged cytopenia. Two of the three patients died from complications of prolonged cytopenia. Monitor blood counts prior to and after ABECMA infusion. Manage cytopenia with myeloid growth factor and blood product transfusion support.

Hypogammaglobulinemia: Hypogammaglobulinemia was reported as an adverse event in 21% (27/127) of patients; laboratory IgG levels fell below 500 mg/dl after infusion in 25% (32/127) of patients treated with ABECMA.

Monitor immunoglobulin levels after treatment with ABECMA and administer IVIG for IgG <400 mg/dl. Manage appropriately per local institutional guidelines, including infection precautions and antibiotic or antiviral prophylaxis.

The safety of immunization with live viral vaccines during or after ABECMA treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during ABECMA treatment, and until immune recovery following treatment with ABECMA.

Secondary Malignancies: Patients treated with ABECMA may develop secondary malignancies. Monitor life-long for secondary malignancies. If a secondary malignancy occurs, contact Bristol-Myers Squibb at 1-888-805-4555 to obtain instructions on patient samples to collect for testing of secondary malignancy of T cell origin.

Effects on Ability to Drive and Operate Machinery: Due to the potential for neurologic events, including altered mental status or seizures, patients receiving ABECMA are at risk for altered or decreased consciousness or coordination in the 8 weeks following ABECMA infusion. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period.

Adverse Reactions: The most common nonlaboratory adverse reactions (incidence greater than or equal to 20%) include CRS, infections – pathogen unspecified, fatigue, musculoskeletal pain, hypogammaglobulinemia, diarrhea, upper respiratory tract infection, nausea, viral infections, encephalopathy, edema, pyrexia, cough, headache, and decreased appetite.

Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.

About 2seventy bio

Our name, 2seventy bio, reflects why we do what we do – TIME. Cancer rips time away, and our goal is to work at the maximum speed of translating human thought into action – 270 miles per hour – to give the people we serve more time. We are building the leading immuno-oncology cell therapy company, focused on discovering and developing new therapies that truly disrupt the cancer treatment landscape With a deep understanding of the human body’s immune response to tumor cells and how to translate cell therapies into practice, we’re applying this knowledge to deliver next generation cellular therapies that focus on a broad range of hematologic malignancies, including the first FDA-approved CAR T cell therapy for multiple myeloma, as well as solid tumors. Our research and development is focused on delivering therapies that are designed with the goal to “think” smarter and faster than the disease. Importantly, we remain focused on accomplishing these goals by staying genuine and authentic to our “why” and keeping our people and culture top of mind every day.

For more information, visit www.2seventybio.com.

Follow 2seventy bio on social media: Twitter and LinkedIn.

2seventy bio is a trademark of 2seventy bio, Inc.

2seventy bio Cautionary Note Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development, and commercialization of Abecma. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These statements include, but are not limited to: statements about our plans, timelines and expectations with respect to the development of ide-cel, including the results and expected timing of ongoing and planned clinical trials; statements about the efficacy and perceived therapeutic benefits of ide-cel and the potential indications and market opportunities and demand therefor. These risks, assumptions, uncertainties, and other factors include, among others, the possibility that ide-cel will not be successful in earlier lines of therapy, may not be commercially successful, that continued approval of such product candidate for such indication described in this release may be contingent upon verification and description of clinical benefit in confirmatory trials, and that the collaboration with Bristol Myers Squibb may not continue or be successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect 2seventy bio’s business, particularly those identified in the risk factors discussion in 2seventy bio’s Annual Report on Form 10-K, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, 2seventy bio undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

Hyperlinks are provided as a convenience and for informational purposes only. 2seventy bio does not bear responsibility for the security or content of external websites or websites outside of their respective control.

Investors:

Jenn Snyder

617-448-0281

[email protected]

Media:

Morgan Adams

774.313.9852

[email protected]

KEYWORDS: Illinois Massachusetts Germany Europe United States North America

INDUSTRY KEYWORDS: Oncology Health General Health Clinical Trials Research Science Biotechnology

MEDIA:

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Activision Blizzard Releases 2022 Environmental, Social, and Governance Report

Activision Blizzard Releases 2022 Environmental, Social, and Governance Report

Company meets 2022 commitments and announces 2023 commitments to continue championing its people, recruiting and developing diverse talent, welcoming players of all backgrounds, and protecting the planet

SANTA MONICA, Calif.–(BUSINESS WIRE)–
Activision Blizzard today released its third Environment, Social, and Governance (ESG) Report for 2022. The 2022 Report represents the company’s continued commitment to operate transparently, responsibly, and ethically. It details how Activision Blizzard is championing its people, advancing more diverse and inclusive communities, and protecting the planet. You can access the full report on the company’s website and a summary of the report below.

“Over the last year across Activision Blizzard, we stepped up our ESG efforts. We take the responsibility of connecting and engaging with hundreds of millions of people through epic entertainment seriously. Gaming is a cultural force, and for gaming to have the biggest impact, we must attract and retain a highly talented and diverse workforce and build a welcoming and inclusive workplace,” said Brian Bulatao, Chief Administrative Officer of Activision Blizzard and Chair of the company’s ESG Steering Committee. “We are deeply proud of the progress we’ve made on our 2022 ESG initiatives, and we are committed to continuous improvement in each of our key pillars.”

2022 Results:

Championing Our People

Over the last year, Activision Blizzard has made meaningful progress toward its 2021 goal to increase the combined percentage of women and non-binary employees in its workforce by 50% over five years and use its $250 million fund to accelerate opportunities for diverse talent within gaming and technology. The 2022 highlights include:

  • All business units saw an increase in the combined representation of women and non-binary employees. As of November 30, 2022, approximately 26% of our global employee population self-reported as women or non-binary people, up from approximately 24% as of November 30, 2021.

  • Women in game development leadership roles more than quadrupled since 2016. The company grew game development teams by 25% in 2022.

  • Globally, employees who self-reported as women or non-binary people, or who self-reported as something else earned on average $1.00 for every $1.00 earned by men for comparable work.

  • The company expanded benefits to include unlimited virtual counseling sessions through BetterHelp, increased adoption benefit to $20,000 from $5,000, and more.

Advancing Diverse and Inclusive Communities

Diversity and inclusion are foundational to the company’s games, policies, and workforce commitments. In 2022 the company made strong progress as it:

  • Hired its first Chief Diversity, Equity, and Inclusion Officer, Kristen Hines.

  • Appointed its first Head of Inclusive Game Design, Adrian Ledda, who helped develop a consistent approach to embedding inclusive game design into content pipeline reviews.

  • Initiated a partnership with Reboot Representation to help increase the number of Black, Latina, and Native American women in technology through a $2 million grant funded by the company.

  • Funded the placement of nearly 16,000 veterans into high-quality jobs through the Call of Duty Endowment in 2022. With over 113,000 veterans placed between 2009-2022, total veteran job placements is now over 118,000.

Protecting the Planet

Activision Blizzard is committed to reaching net zero carbon emissions by 2050. To achieve this goal, the company has developed a decarbonization roadmap and has created a detailed operating plan to reduce carbon intensity, water usage, and waste. The 2022 highlights include:

  • Estimated greenhouse gas emissions remained relatively stable in 2022, despite increased post-pandemic business travel and other factors, and the company is driving a number of proactive decarbonization efforts that have begun to yield positive results.

  • The company continued to prioritize environmental efficiencies across data centers and workplaces – 61% of data center and workplace energy came from purchased renewable energy, up from less than 1% in 2021.

  • Workplace emission reductions were driven by the company’s largest campus joining the City of Irvine’s Community Choice Aggregation program, which now allows it to use 100% renewable energy.

In the ESG report, Activision Blizzard also details its 2023 goals and commitments such as publishing employee promotion rates by gender globally and by race and ethnicity in the US; launching a local studio ambassador program to increase opportunities for DE&I work in game teams and gaming experiences; and beginning to address carbon emissions generated through our workplaces, performance marketing activities, travel practices, game development, and public cloud utilization.

Through the release of its annual ESG Report, the company continues to transparently share its efforts to advocate for its people, invest in building diverse communities, and prioritize sustainable business practices. Access the report on the company’s ESG website here and read a note from Brian Bulatao, Chief Administrative Officer of Activision Blizzard and Chair of the company’s ESG Steering Committee on the company’s blog here.

About Activision Blizzard

Our mission to connect and engage the world through epic entertainment has never been more important. Through communities rooted in our video games, we enable hundreds of millions of people to experience joy, thrill, and achievement. We enable social connections through the lens of fun, and we foster purpose and a sense of accomplishment through healthy competition. Like sport, but with greater accessibility, our players can find purpose and meaning through competitive gaming. Video games, unlike any other social or entertainment media, have the ability to break down the barriers that can inhibit tolerance and understanding. Celebrating differences is at the core of our culture and ensures we can create games for players of diverse backgrounds in the 190 countries our games are played.

As a member of the Fortune 500 and as a component company of the S&P 500, we have an extraordinary track record of delivering superior shareholder returns for over 30 years. Our sustained success has enabled the company to support corporate social responsibility initiatives that are directly tied to our games. As an example, our Call of Duty Endowment has helped find employment for over 100,000 veterans.

Learn more information about Activision Blizzard and how we connect and engage the world through epic entertainment on the company’s website, www.activisionblizzard.com.

Cautionary Note Regarding Forward-Looking Statements

This press release may contain forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company’s current expectations. These and other risks are described in the Company’s periodic reports, including the annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available at www.sec.gov. Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release. The Company assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

[email protected]

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Software Entertainment Professional Services Philanthropy Sustainability Consumer Electronics Technology Environment DEI (Diversity, Equity and Inclusion) Foundation Electronic Games Environmental, Social and Governance (ESG)

MEDIA:

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Aspira Women’s Health Announces 1-for-15 Reverse Stock Split

AUSTIN, Texas, May 11, 2023 (GLOBE NEWSWIRE) — Aspira Women’s Health Inc. (“Aspira”) (Nasdaq: AWH), a bio-analytical based women’s health company focused on the development of gynecologic disease diagnostic, tools, today announced a 1-for-15 reverse stock split of its outstanding common stock, effective at 12:01 am Eastern time on May 11, 2023. Beginning tomorrow, May 12, 2023, the Company’s common stock will trade on a split-adjusted basis.

At the Company’s Annual Meeting of Stockholders meeting held on May 9, 2023, the Company’s stockholders approved a proposal to its Amended and Restated Certificate of Incorporation to effect a reverse stock split of its outstanding shares of common stock, par value $0.001 per share, by a ratio of any whole number between 1-for-10 to 1-for-20, the implementation and timing of which was subject to the discretion of the Company’s Board of Directors. On May 9, 2023, the Board of Directors approved a 1-for-15 reverse split, and on May 11, 2023, the Company filed a Certificate of Amendment to its Amended and Restated Certificate of Incorporation to affect the reverse stock split.

The Company’s Board of Directors implemented the reverse stock split with the objective of regaining compliance with the $1.00 minimum bid price requirement of The Nasdaq Capital Market. To comply with this requirement, the closing bid of the Company’s common stock must be at least $1.00 per share for a minimum of 10 consecutive business days prior to May 29, 2023. The Company has until May 29, 2023, to comply with this requirement.

The Company’s shares of common stock will continue to trade on the NASDAQ under the symbol “AWH.” The new CUSIP number for the Company’s common stock post-reverse stock split is 04537Y 208.

Upon the effectiveness of the reverse stock split, every 15 shares of the Company’s issued and outstanding common stock will automatically be converted into one share of common stock. Any fraction of a share of common stock that would be created as a result of the reverse stock split will be paid out.

About Aspira Women’s Health Inc.
Aspira Women’s Health Inc. is transforming women’s gynecological health with the discovery, development, and commercialization of innovative testing options for women of all races and ethnicities.

Our ovarian cancer risk assessment portfolio is marketed to healthcare providers as OvaSuiteSM. OvaWatchSM is a non-invasive, blood-based test intended for use in the initial clinical assessment of ovarian cancer risk in women with benign or indeterminate adnexal masses for which surgical intervention may be either premature or unnecessary. With a negative predictive value (NPV) of 99%, OvaWatch allows physicians to confidently rule out ovarian cancer malignancy and choose the appropriate clinical management for the right patient at the right time.

Ova1Plus® combines our FDA-cleared products, Ova1® and OVERA®, to detect risk of ovarian malignancy in women with adnexal masses planned for surgery.

EndoCheck™, Aspira’s first-of-its-kind non-invasive diagnostic test for endometriosis, is currently in development. Visit our website for more information at www.aspirawh.com.

Forward-Looking Statements
This press release contains forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995, including statements regarding the potential effects of widespread use of OvaWatch and the availability of OvaWatch in New York. Forward-looking statements involve a number of risks and uncertainties. Words such as “may,” “expects,” “intends,” “anticipates,” “believes,” “estimates,” “plans,” “seeks,” “could,” “should,” “continue,” “will,” “potential,” “projects” and similar expressions are intended to identify forward-looking statements. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including those described in the section entitled “Risk Factors” in Aspira’s Annual Report on Form 10-K for the year ended December 31, 2022. These risks include, but are not limited to: our ability to continue as a going concern; our ability to comply with Nasdaq’s continued listing requirements; impacts resulting from potential changes to coverage of Ova1 through our Medicare Administrative Carrier for Ova1; impacts resulting from or relating to the COVID-19 pandemic and actions taken to contain it; anticipated use of capital and its effects; our ability to increase the volume of our product sales; failures by third-party payers to reimburse for our products and services or changes to reimbursement rates; our ability to continue developing existing technologies and to develop, protect and promote our proprietary technologies; plans to develop and perform laboratory developed tests; our ability to comply with Food and Drug Administration (“FDA”) regulations that relate to our products and to obtain any FDA clearance or approval required to develop and commercialize medical devices; our ability to develop and commercialize additional diagnostic products and achieve market acceptance with respect to these products; our ability to compete successfully; our ability to obtain any regulatory approval required for our future diagnostic products; or our suppliers’ ability to comply with FDA requirements for production, marketing and post-market monitoring of our products; our ability to maintain sufficient or acceptable supplies of immunoassay kits from our suppliers; in the event that we succeed in commercializing our products outside the United States, the political, economic and other conditions affecting other countries; changes in healthcare policy; our ability to comply with the additional laws and regulations that apply to us in connection with the operation of ASPIRA LABS; our ability to use our net operating loss carryforwards; our ability to use intellectual property; our ability to successfully defend our proprietary technology against third parties; our ability to obtain licenses in the event a third party successfully asserts proprietary rights; the liquidity and trading volume of our common stock; the concentration of ownership of our common stock; our ability to retain key employees; our ability to secure additional capital on acceptable terms to execute our business plan; business interruptions; the effectiveness and availability of our information systems; our ability to integrate and achieve anticipated results from any acquisitions or strategic alliances; future litigation against us, including infringement of intellectual property and product liability exposure; and additional costs that may be required to make further improvements to our laboratory operations. The events and circumstances reflected in Aspira’s forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Aspira expressly disclaims any obligation to update, amend or clarify any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.


Investor Relations Contact:


Monique Kosse
Managing Director
LifeSci Advisors, LLC
Tel: 212-915-3820



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ADC Therapeutics Announces Updated Results from LOTIS-2 Trial to be Presented at the European Hematology Association 2023 Hybrid Congress

ADC Therapeutics Announces Updated Results from LOTIS-2 Trial to be Presented at the European Hematology Association 2023 Hybrid Congress

 Poster presentation will highlight durable, long-term responses in relapsed/refractory DLBCL patients treated with ZYNLONTA®

LAUSANNE, Switzerland–(BUSINESS WIRE)–
ADC Therapeutics SA (NYSE: ADCT) today announced updated results from LOTIS-2, the pivotal Phase 2 clinical trial of ZYNLONTA® (loncastuximab tesirine-lpyl) in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), have been accepted for presentation at the European Hematology Association 2023 Hybrid Congress (EHA2023), which will be held in Frankfurt, Germany from June 8-11, 2023.

“We are encouraged by the latest developments from our pivotal LOTIS-2 trial, which further validate the long‐term disease control of ZYNLONTA in heavily pretreated patients with DLBCL,” said Mohamed Zaki, MD, PhD, Chief Medical Officer of ADC Therapeutics. “ZYNLONTA has substantial single-agent antitumor activity and produces durable responses with an acceptable safety profile. We look forward to sharing our new data with the hematology community at EHA2023.”

Details of ADC Therapeutics’ poster presentation are as follows:

Long-Term Responses with Loncastuximab Tesirine: Updated Results From LOTIS-2, the Pivotal Phase 2 Study In Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Session: Aggressive Non-Hodgkin lymphoma – Clinical

Session Date and Time: Friday, June 9, 2023, 18:00 – 19:00 CEST // 12:00 pm – 1:00 pm EDT

Location: Poster area

Location Time: Poster area opens at 9:00 am CEST

Presenting Author: Paolo F. Caimi, MD, Cleveland Clinic Taussig Cancer Center, Cleveland, OH, USA

Abstract Code: P1132

About ZYNLONTA® (loncastuximab tesirine-lpyl)

ZYNLONTA® is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.

The U.S. Food and Drug Administration (FDA) has approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL not otherwise specified, DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Please see full prescribing information including important safety information about ZYNLONTA at www.ZYNLONTA.com.

ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.

About ADC Therapeutics

ADC Therapeutics (NYSE: ADCT) is a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs). The Company is advancing its proprietary ADC technology to transform the treatment paradigm for patients with hematologic malignancies and solid tumors.

ADC Therapeutics’ CD19-directed ADC ZYNLONTA (loncastuximab tesirine-lpyl) received accelerated approval by the FDA and conditional approval from the European Commission for the treatment of relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy. ZYNLONTA is also in development in combination with other agents and in earlier lines of therapy. In addition to ZYNLONTA, ADC Therapeutics has multiple ADCs in ongoing clinical and preclinical development.

ADC Therapeutics is based in Lausanne (Biopôle), Switzerland and has operations in London, the San Francisco Bay Area and New Jersey. For more information, please visit https://adctherapeutics.com/ and follow the Company on Twitter and LinkedIn.

ZYNLONTA® is a registered trademark of ADC Therapeutics SA.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: the benefits, if any, of the updated clinical data from the LOTIS-2 study of ZYNLONTA® to be presented at EHA 2023; the success of the Company’s updated corporate strategy including operating efficiencies, capital deployment and portfolio prioritization; the Company’s ability to achieve the 2023 net product sales guidance for ZYNLONTA® and the decrease in total operating expenses for 2023 and 2024, the expected cash runway into the middle of 2025, the effectiveness of the new commercial go-to-market strategy and the Company’s ability to continue to commercialize ZYNLONTA® in the United States and future revenue from the same; Swedish Orphan Biovitrum AB (Sobi®) ability to successfully commercialize ZYNLONTA® in the European Economic Area and market acceptance, adequate reimbursement coverage, and future revenue from the same; our strategic partners’, including Mitsubishi Tanabe Pharma Corporation and Overland Pharmaceuticals, ability to obtain regulatory approval for ZYNLONTA® in foreign jurisdictions, and the timing and amount of future revenue and payments to us from such partnerships; the Company’s ability to market its products in compliance with applicable laws and regulations; the Company’s expectations regarding the impact of the Infrastructure Investment and Jobs Act; the timing and results of the Company’s or its partners’ research projects or clinical trials including LOTIS 5, 7 and 9, ADCT 901, 601 and 602, the timing and outcome of regulatory submissions and actions by the FDA or other regulatory agencies with respect to the Company’s products or product candidates; projected revenue and expenses; the Company’s indebtedness, including Healthcare Royalty Management and Blue Owl and Oaktree facilities, and the restrictions imposed on the Company’s activities by such indebtedness, the ability to repay such indebtedness and the significant cash required to service such indebtedness; the Company’s ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as “may”, “will”, “should”, “would”, “expect”, “intend”, “plan”, “anticipate”, “believe”, “estimate”, “predict”, “potential”, “seem”, “seek”, “future”, “continue”, or “appear” or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the “Risk Factors” section of the Company’s Annual Report on Form 20-F and in the Company’s other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this document. The Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

Investors

Eugenia Litz

ADC Therapeutics

[email protected]

+44 7879 627205

Amanda Loshbaugh

ADC Therapeutics

[email protected]

+1 917-288-7023

Media

Mary Ann Ondish

ADC Therapeutics

[email protected]

+1 914-552-4625

KEYWORDS: Switzerland Europe Germany

INDUSTRY KEYWORDS: Health Science Research Clinical Trials Oncology

MEDIA:

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FedEx Awards More Than $330,000 to Winners of the FedEx Small Business Grant Contest

FedEx Awards More Than $330,000 to Winners of the FedEx Small Business Grant Contest

Eleventh annual contest receives more than 8,200 entries

MEMPHIS, Tenn.–(BUSINESS WIRE)–
FedEx Corp. (NYSE: FDX) unveiled the winners of the 11th annual FedEx Small Business Grant Contest. Ten U.S.-based businesses were chosen this year out of over 8,200 entries.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230511005212/en/

(Photo: Business Wire)

(Photo: Business Wire)

Grand Prize Winners:

$30,000, plus $1,000 in FedEx Officeprint and business services

“At FedEx, we are committed to empowering entrepreneurs and providing the resources they need to succeed,” said Executive Vice President and Chief Customer Officer, Brie Carere. “We’re excited to shine a spotlight on these incredible small businesses and look forward to supporting them as they continue to grow and thrive.”

Chesapeake BAYDOG, a veteran owned small business, was awarded an additional $20,000 courtesy of United States Automobile Association (USAA) Small Business Insurance.

All winners also received a $300 voucher from My FedEx Rewards, access to FedEx Premier Customer Service, a sustainable packaging consult from FedEx Packaging Lab, a digital consult from the FedEx Digital Sales Solutions team, 20% off of a SEO monthly plan from HigherVisibility, a mentorship session with select member-founders in Entrepreneurs’ Organization, an invite to attend a FedEx Grant Winner Forum, a feature on the FedEx Small Business Center, and an international trade dictionary courtesy of FedEx.

The grant winners aren’t the only small business owners that have benefitted. All Top 100 finalists were offered a financial consultation with Accion Opportunity Fund. The finalists have also been awarded free access to the Initiative for a Competitive Inner City (I.C.I.C.) Annual Conference, its Digital Learning Platform, and access to up to three of its webinars.

An exciting new addition to this year’s contest was the People’s Choice Awards, a 10-day voting period in which the public voted for a daily winner among all of the entrants. The People’s Choice Awards provided entrants a chance to win one of ten $1,000 digital cash gift cards. One gift card per day was awarded to the qualified small business with the highest number of likes on their entry that particular day.

People’s Choice Award Winners:

$1,000 digital cash gift cards

Over the past eleven years, nearly 80,000 businesses have entered the contest in the United States alone. FedEx has awarded more than $1.98 million total in grant money and printing credits combined since the contest’s inception.

About FedEx Corp.

FedEx Corp. (NYSE: FDX) provides customers and businesses worldwide with a broad portfolio of transportation, e-commerce and business services. With annual revenue of $93 billion, the company offers integrated business solutions through operating companies competing collectively, operating collaboratively and innovating digitally as one FedEx. Consistently ranked among the world’s most admired and trusted employers, FedEx inspires its more than 530,000 employees to remain focused on safety, the highest ethical and professional standards and the needs of their customers and communities. FedEx is committed to connecting people and possibilities around the world responsibly and resourcefully, with a goal to achieve carbon-neutral operations by 2040. To learn more, please visit about.fedex.com.

Casey Gleysteen

FedEx Media Relations

(901) 713-0241

[email protected]

KEYWORDS: Tennessee United States North America

INDUSTRY KEYWORDS: Supply Chain Management Technology Professional Services Other Transport Trucking Electronic Commerce Small Business Air Transport Retail Logistics/Supply Chain Management

MEDIA:

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(Photo: Business Wire)
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Dime Announces Upgrades to Technology Platform

HAUPPAUGE, N.Y., May 11, 2023 (GLOBE NEWSWIRE) — Dime Community Bancshares, Inc. (the “Company” or “Dime”) (NASDAQ: DCOM), the parent company of Dime Community Bank (the “Bank”), announced today a number of upgrades to its technology platform, including a move to a brand-new escrow management platform as well as enhanced digital banking capabilities. Dime expects to roll out these new capabilities starting in early June.

Dime also successfully added several deposit gathering Groups over the past month and continues to capitalize on recent disruption in its marketplace.

Kevin O’ Connor, Chief Executive Officer of the Company, stated, “We are pleased to announce significant upgrades to our technology stack. These new additions will enhance our ability to attract new commercial customers and help drive the long-term growth of our deposit base. Our bank-wide technology capabilities were instrumental in our hiring of four seasoned deposit gathering Groups over the past month. The enhancements announced today coincide with the buildout of our Private Banking Groups and will only further accelerate our suite of offerings. In addition to maintaining a low level of non-insured deposits (excluding deposits with pass-through insurance and collateralized deposits) of only 28.6% on April 30th, 2023, we continue to have a strong pipeline of new Group hires that will be exclusively focused on deposit gathering that we expect to onboard in the months ahead.”

ABOUT DIME COMMUNITY BANCSHARES, INC.

Dime Community Bancshares, Inc. is the holding company for Dime Community Bank, a New York State-chartered trust company with over $13.8 billion in assets and the number one deposit market share among community banks on Greater Long Island (1).

Dime Community Bancshares, Inc.

Investor Relations Contact:
Avinash Reddy
Senior Executive Vice President – Chief Financial Officer
Phone: 718-782-6200; Ext. 5909
Email: [email protected]

____________________
(1) Aggregate deposit market share for Kings, Queens, Nassau & Suffolk counties for community banks with less than $20 billion in assets.



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NeuroOne® to Report Second Quarter Fiscal Year 2023 Financial Results and Provide a Corporate Update on May 11

EDEN PRAIRIE, Minn., May 11, 2023 (GLOBE NEWSWIRE) — NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) (“NeuroOne” or the “Company”), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, will host a conference call to discuss financial results for its fiscal second quarter 2023 ended March 31, 2023 and provide a corporate update on May 11, 2023 at 4:30 PM Eastern Time.

Conference Call
and Webcast
Information
:

Thursday, May 11, 2023 – 4:30 PM Eastern Time

Participant Dial-In:
888-645-4404 / 862-298-0702

Live Webcast: 
Join here.

Phone Replay:
877-660-6853 / 201-612-7415, Access ID: 13738525; available through May 25, 2023

Webcast Replay:        
Available for 12 months

About NeuroOne

NeuroOne Medical Technologies Corporation is a developmental stage company committed to providing minimally invasive and hi-definition solutions for EEG recording, brain stimulation and ablation solutions for patients suffering from epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders that may improve patient outcomes and reduce procedural costs. The Company may also pursue applications for other areas such as depression, mood disorders, pain, incontinence, high blood pressure, and artificial intelligence. For more information, visit nmtc1.com.

Contact:

800-631-4030
[email protected]



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SpringWorks Therapeutics Announces Clinical Data Presentations of Nirogacestat in Combination with BCMA-Directed Therapies at the European Hematology Association 2023 Congress

STAMFORD, Conn., May 11, 2023 (GLOBE NEWSWIRE) — SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, announced today that data from two collaborator-sponsored clinical studies evaluating nirogacestat, an investigational oral gamma secretase inhibitor, in combination with B-cell maturation agent (BCMA) therapies in patients with relapsed or refractory multiple myeloma (RRMM) will be presented at the European Hematology Association (EHA) 2023 Congress, taking place in Frankfurt, Germany from June 8-11, 2023. Updated clinical data from the Phase 1/2 study sponsored by GSK plc (LSE/NYSE: GSK) evaluating nirogacestat in combination with low-dose belamaf (belantamab mafodotin-blmf), GSK’s antibody-drug conjugate targeting BCMA, in patients with RRMM will be presented in a poster presentation. In addition, new data from the Phase 1b clinical trial sponsored by Janssen Research & Development, LLC (Janssen) evaluating nirogacestat in combination with teclistamab, Janssen’s bispecific antibody targeting BCMA and CD3, will be presented in an oral presentation.

“These data provide further validation of the mechanistic approach supporting nirogacestat’s ability to enhance the activity of BCMA-directed therapies across modalities. We are pleased that updated data from the GSK-sponsored trial continue to support our thesis that the combination with nirogacestat may further optimize the benefit-risk profile of belamaf monotherapy. We are also encouraged that the Janssen-sponsored trial establishes an initial tolerability, safety and efficacy profile for combining nirogacestat with a BCMA bispecific antibody,” said Saqib Islam, Chief Executive Officer of SpringWorks. “Our goal is to improve the outcomes for patients with multiple myeloma and we believe that developing a robust clinical data set across BCMA modalities and treatment lines can help us demonstrate where within the multiple myeloma treatment landscape nirogacestat has the greatest opportunity to maximize clinical benefit.”


Poster Presentation at the EHA 2023 Congress

Low-dose belantamab mafodotin (belamaf) in combination with nirogacestat vs belamaf monotherapy in patients with relapsed/refractory multiple myeloma (RRMM): Phase 1/2 DREAMM-5 Platform Sub-study 3

Abstract #: P913

Session Date and Time: Friday, June 9, 18:00-19:00 CEST (12:00-1:00 p.m. ET)

This ongoing Phase 1/2 trial, which is sub-study 3 of GSK’s DREAMM-5 platform trial (NCT04126200), aims to determine if low-dose belamaf in combination with nirogacestat results in similar efficacy with an improved ocular toxicity profile compared to belamaf alone at a higher dose. Patients were randomized 1:1 to 0.95 mg/kg belamaf every three weeks (Q3W, low-dose) combined with 100 mg twice daily nirogacestat or belamaf 2.5 mg/kg Q3W monotherapy.

Initial results from the pre-planned interim analysis were presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. Updated data from a randomized cohort expansion in which 34 patients received low-dose belamaf plus nirogacestat and 37 patients received belamaf monotherapy will be presented at EHA. Patients had a median of 5 (range 3-14) prior lines of therapy. As of the December 9, 2022 data cut-off, patients received a median of 4 (range 1-20) cycles of the combination and a median of 3 (range 1-9) monotherapy cycles.

Overall response rate (ORR) in the low-dose belamaf (0.95 mg/kg Q3W) plus nirogacestat arm was 29%, with 1 patient (3%) achieving a complete response (CR), 5 patients (15%) achieving a very good partial response (VGPR), and 4 patients (12%) achieving a partial response (PR). ORR in the belamaf monotherapy arm (2.5 mg/kg Q3W) was 38%, with no patient achieving a CR, 5 patients (14%) achieving a VGPR, and 9 patients (24%) achieving a PR. Per the prespecified analysis plan, ORR was also calculated incorporating prior ORR for low-dose belamaf plus nirogacestat from the dose exploration cohort of this DREAMM-5 sub-study 3 and from the DREAMM-2 belamaf monotherapy study; ORR across these studies was 36% in the low-dose belamaf plus nirogacestat combination arm and 33% in the belamaf monotherapy arm.

Safety results showed a substantial reduction of high-grade ocular events in the low-dose belamaf plus nirogacestat arm compared to the monotherapy arm of belamaf at a higher dose. Specifically, Grade 3 ocular events were 29% for low-dose belamaf + nirogacestat versus 59% for belamaf monotherapy (per the KVA scale); no Grade 4 ocular events or new toxicities occurred in either arm.

“These clinical data suggest that combining nirogacestat with a low dose of belamaf may result in comparable efficacy to a higher monotherapy belamaf dose, while simultaneously substantially reducing the frequency high-grade ocular adverse events,” said Jim Cassidy, M.D., Ph.D., Chief Medical Officer of SpringWorks. “We are encouraged by these results and we look forward to the further evaluation of this combination with standard of care agents in relapsed refractory multiple myeloma as well as its potential in earlier lines of therapy.”


Oral Presentation at the EHA 2023 Congress

Teclistamab (tec) + nirogacestat (niro) in relapsed/refractory multiple myeloma (RRMM): the Phase 1b MajesTEC-2 study

Session Title: MM Clinical: New combinations and novel targets

Abstract #: S194

Session Date and Time: Saturday, June 10, 12:30-12:45 CEST (6:30-6:45 a.m. ET)

This ongoing Phase 1b trial (NCT04722146), which is part of a multi-arm trial being conducted by Janssen, aims to evaluate the safety, tolerability and preliminary efficacy of nirogacestat in combination with teclistamab in patients with RRMM. Patients in the study had received ≥3 prior lines of therapy or were double refractory to a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) and triple exposed to a PI, an IMiD, and an anti-CD38 antibody, with progressive disease within 12 months of their last line of therapy. Three dose levels were evaluated: 1) teclistamab 720 μg/kg weekly plus concurrent nirogacestat 100 mg twice daily starting with the first dose of teclistamab (n=8); 2) teclistamab 720 μg/kg weekly plus once daily nirogacestat 100 mg starting after teclistamab step-up dosing (n=7); and 3) 1500 μg/kg (which is the FDA-approved dose) weekly plus once daily nirogacestat 100 mg starting after teclistamab step-up dosing (n=13).

As of the December 16, 2022 data cut-off, 28 patients received the combination of teclistamab and nirogacestat across three different dose levels. Median prior lines of therapy was 4 (range 2-12) and median duration of treatment was 9.4 months (range 0.13-19.7) for teclistamab and 4.7 months for nirogacestat (range 0.16-13.0).

The most frequent (>20%) treatment-emergent adverse events (TEAEs) for all doses were neutropenia (82%), cytokine release syndrome, or CRS (75%), diarrhea (64%), injection-site erythema (54%), decreased appetite (50%), fatigue (42.9%), and anemia (35%). Of eight patients who received teclistamab 720 μg/kg plus concurrent nirogacestat, two dose-limiting toxicities were reported (one Grade 3 GI bleed and Grade 3 diarrhea; one Grade 3 immune effector cell-associated neurotoxicity syndrome, or ICANS). In addition, one patient had Grade 3 CRS and one patient had Grade 3 confusional state. These events led to the decision to delay the starting dose of nirogacestat in subsequent cohorts. In the dose level 2 and dose level 3 cohorts, when nirogacestat was added after teclistamab step-up dosing and reduced to once daily, no dose-limiting toxicities or Grade 3 CRS or neurologic adverse events were reported.

The overall response rate was 71% for dose level 1, 57% for dose level 2, and 92% for dose level 3. The total ORR across the three dose levels was 78% and all responses were VGPR or better. The percentage of patients experiencing complete response (CR) or stringent CR (sCR) was 43%, 57% and 54%, respectively (total percentage of CR or sCR across the three cohorts was 52%).

“This is the first clinical data set of nirogacestat in combination with a BCMA bispecific agent. We believe these data provide important insights into a tolerable treatment schedule and early evidence of an encouraging ORR, including promising CR and sCR rates, when combining nirogacestat with this BCMA modality,” commented Dr. Cassidy. “Nirogacestat is being evaluated in combination with three other bispecific agents and we look forward to generating more data with these combinations.”

About Nirogacestat

Nirogacestat is an oral, selective, small molecule gamma secretase inhibitor in Phase 3 clinical development for desmoid tumors and in Phase 2 clinical development for ovarian granulosa cell tumors. Nirogacestat is an investigational drug for which safety and efficacy have not been established.

Gamma secretase cleaves multiple transmembrane protein complexes, including Notch, which is believed to play a role in activating pathways that contribute to growth of desmoid and ovarian granulosa cell tumors. Gamma secretase has also been shown to directly cleave membrane-bound B cell maturation antigen (BCMA), resulting in the release of the BCMA extracellular domain (ECD) from the cell surface. By inhibiting gamma secretase, membrane-bound BCMA can be preserved, increasing target density while reducing levels of soluble BCMA ECD, which may serve as decoy receptors for BCMA-directed therapies. Nirogacestat’s ability to enhance the activity of BCMA-directed therapies has been observed in preclinical models of multiple myeloma. SpringWorks is evaluating nirogacestat as a BCMA potentiator and has several collaborations with industry-leading BCMA developers to evaluate nirogacestat in combinations across modalities. SpringWorks has also formed research collaborations with Fred Hutchinson Cancer Research Center and Dana-Farber Cancer Institute to further characterize the ability of nirogacestat to modulate BCMA and potentiate BCMA-directed therapies using a variety of preclinical multiple myeloma models.

The U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for nirogacestat for the treatment of adults with desmoid tumors, which is being reviewed under the FDA’s Real-Time Oncology Review program. The NDA was granted Priority Review designation and has been given a Prescription Drug User Fee Act (PDUFA) action date of August 27, 2023. The FDA also granted Fast Track and Breakthrough Therapy Designations to nirogacestat for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis. In addition, nirogacestat has received Orphan Drug Designation from the FDA for the treatment of desmoid tumors and from the European Commission for the treatment of soft tissue sarcoma.

About SpringWorks Therapeutics

SpringWorks is a clinical-stage biopharmaceutical company applying a precision medicine approach to acquiring, developing and commercializing life-changing medicines for patients living with severe rare diseases and cancer. SpringWorks has a differentiated targeted oncology pipeline spanning solid tumors and hematological cancers, including two late-stage clinical trials in rare tumor types as well as several programs addressing highly prevalent, genetically defined cancers. SpringWorks’ strategic approach and operational excellence in clinical development have enabled it to rapidly advance its two lead product candidates into late-stage clinical trials while simultaneously entering into multiple shared-value partnerships with innovators in industry and academia to unlock the full potential for its portfolio and create more solutions for patients with cancer. For more information, visit www.springworkstx.com and follow @SpringWorksTx on Twitter and LinkedIn.

SpringWorks Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, relating to our business, operations, and financial conditions, including, but not limited to, current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our development plans, our preclinical and clinical results, as well as relating to other future conditions. Words such as, but not limited to, “look forward to,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” “plan,” “would,” “should” and “could,” and similar expressions or words, identify forward-looking statements. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks relating to: (i) the success and timing of our product development activities, including the initiation and completion of SpringWorks’ clinical trials, (ii) the fact that topline or interim data from a clinical study may not be predictive of the final or more detailed results of such study, or the results of other ongoing or future studies, (iii) the success and timing of our collaboration partners’ ongoing and planned clinical trials, (iv) the timing of our planned regulatory submissions and interactions, including the timing and outcome of decisions made by the U.S. Food and Drug Administration (FDA) and other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies; (v) whether FDA or other regulatory authorities will require additional information or further studies, or may fail or refuse to approve or may delay approval of our drug candidates, (vi) our ability to obtain and maintain regulatory approval of any of our product candidates, (vii) our plans to research, discover and develop additional product candidates, (viii) our ability to maintain adequate patent protection and successfully enforce patent claims against third parties, (ix) our ability to enter into collaborations for the development of new product candidates, (x) our ability to establish manufacturing capabilities, and our and our collaboration partners’ abilities to manufacture our product candidates and scale production, (xi) our ability to meet any specific milestones set forth herein, and (xii) uncertainties and assumptions regarding the impact of the COVID-19 pandemic on SpringWorks’ business, operations, clinical trials, supply chain, strategy, goals and anticipated timelines.

Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements.

For further information regarding the risks, uncertainties and other factors that may cause differences between SpringWorks’ expectations and actual results, you should review the “Risk Factors” in Item 1A of Part II of SpringWorks’ Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, as well as discussions of potential risks, uncertainties and other important factors in SpringWorks’ subsequent filings.

Contacts:

Kim Diamond
Vice President, Communications and Investor Relations
Phone: 203-561-1646
Email: [email protected]

Samantha Hilson Sandler
Senior Director, Investor Relations
Phone: 203-461-5501
Email: [email protected]  



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Maximus Foundation Announces Record High $2.2 Million in Grants to Nonprofits Nationwide

Maximus Foundation Announces Record High $2.2 Million in Grants to Nonprofits Nationwide

191 Nonprofit Organizations Receiving Grants for Community Development, Youth Programs, and Healthcare

TYSONS, Va.–(BUSINESS WIRE)–Maximus (NYSE: MMS), a leading employer and provider of government services worldwide, today announced that the Maximus Foundation will award $2.2 million in grants to 191 nonprofit organizations across the United States this year. The grants are aimed at furthering three key themes that drive the Foundation’s work: community development, youth programs, and healthcare services. The number of grantees represents a 14.3% increase over the number of 2022 grantees, and the total giving is the largest annual level in the Foundation’s 23-year history.

The Maximus Foundation, which was founded by the company’s board of directors in 2000, is committed to supporting organizations and programs that promote personal growth and self-sufficiency through improved health, child, family, and community development.

“This year’s incredible class of grant recipients marks another step forward for the Maximus Foundation expanding the number of organizations and the total investment in our communities,” said Dr. Arvenita Washington Cherry, President and Chairperson, Maximus Foundation. “These inspiring nonprofits make a difference in the communities where Maximus employees work and live. We are extremely proud of our partnerships and how these organizations help improve the lives of thousands of people and families.”

The nonprofits receiving grants in 2023 from the Maximus Foundation provide a wide range of critical services, programs, and training. For community development, grantees focus on areas such as homelessness prevention and supportive services, jobs, and training programs, and veteran-support services. Youth development nonprofits receiving grants provide child abuse prevention and support services, programs to fight child hunger, and education programs in local communities. Dr. John Boyer provided valuable contributions in shaping this year’s historic grant program up until his retirement as Chairman after serving for seventeen years.

“The Maximus Foundation’s annual grant giving is extremely meaningful to Maximus employees, because these nonprofits support and move forward causes and initiatives that are personally important to them,” said Bruce Caswell, President and Chief Executive Officer, Maximus. “The ethos of our company is reflected in our tagline Moving People Forward and our aim as a company is to help as many people as possible. That spirit is evident in everything we do as a company, particularly when it comes to our responsibility as a good corporate citizen and our support for the organizations making change happen in our communities.”

The designated grant awards will continue being distributed over the coming weeks, and some individual organizations will announce their award wins to local communities. For more information on the Maximus Foundation, including full reports on previous grantees, please visit: maximus.com/foundation.

About the Maximus Foundation

As the philanthropic arm of Maximus, the Foundation extends the mission of the company by identifying and awarding grants to partners with specialized expertise to deliver results within the same populations and communities served by the public programs the company operates. The Maximus Foundation is completely funded by Maximus and its employees, in partnership with local community organizations with programs and projects in the areas of child and youth development, health, and community development.

About Maximus

As a leading strategic partner to governments across the globe, Maximus helps improve the delivery of public services amid complex technology, health, economic, environmental, and social challenges. With a deep understanding of program service delivery, acute insights that achieve operational excellence, and an extensive awareness of the needs of the people being served, our employees advance the critical missions of our partners. Maximus delivers innovative business process management, impactful consulting services, and technology solutions that provide improved outcomes for the public and higher levels of productivity and efficiency of government-sponsored programs. For more information, visit maximus.com.

InvestorRelations

James Francis

Jessica Batt

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Media & Public Relations

Eileen Cassidy Rivera

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INDUSTRY KEYWORDS: Consulting Data Management Technology Professional Services Philanthropy Other Policy Issues Other Philanthropy Software Fund Raising Foundation Public Policy/Government

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