CrossFirst Bankshares Announces Passing of Vice Chairman George F. Jones, Jr.

LEAWOOD Kan., May 24, 2021 (GLOBE NEWSWIRE) — CrossFirst Bankshares, Inc. (“CrossFirst” or “Company”) (NASDAQ: CFB), the holding company for CrossFirst Bank (the “Bank”), announced today that George F. Jones, Jr., 77, Vice Chairman of CrossFirst and a member of the Board of Directors, passed away on May 21, 2021.

“We are deeply saddened by the news of George’s passing. George was an outstanding mentor, advisor and an integral member of our Board. With more than four decades of experience in the banking industry, he brought incredible insight and significant experience to our Company,” said CrossFirst Chairman Rod Brenneman. “Working alongside George has been a privilege for me and the other members of the CrossFirst Board and executive leadership team. We will all miss him greatly.”

Mr. Jones joined CrossFirst in 2016 after a 15-year career at Texas Capital Bank. In May 2018, he was named President and Chief Executive Officer of CrossFirst Bankshares and successfully led the Company through a transition to the public markets. In June 2020, Mr. Jones returned to his role as Vice Chairman and transitioned the role of President and Chief Executive Officer to Mike Maddox.

“Over the past five years, George’s leadership and guidance have played a critical role in our Company’s success. We will continue to honor George and his legacy of incredible business acumen and passion for extraordinary service across our entire Company and throughout our industry for years to come,” said CrossFirst President and CEO Mike Maddox. “We offer our deepest condolences to George’s family.”

ABOUT GEORGE JONES

Prior to joining CrossFirst, Mr. Jones, 77, was CEO of Texas Capital Bank and its parent company, Texas Capital Bancshares, Inc. He also was previously president and CEO of NorthPark National Bank, president of NorthPark National Corporation and a member of both Boards. Mr. Jones also served as president and CEO for Texas American Bank, Dallas, and manager of financial institutions with Mercantile National Bank, Dallas. He is a graduate of the University of North Texas with a bachelor’s degree in business administration and the Graduate School of Banking at Southern Methodist University. He served on the board of Caliber Home Loans, Inc., Dallas and was chairman of the Audit and Compensation Committees. Mr. Jones was active with the Salesmanship Club of Dallas and a past chairman of the Salesmanship Club Foundation Board of Trustees. Mr. Jones served on the board of the Federal Reserve Bank of Dallas and was a member of the Audit Committee. He also was a member of the Dallas Citizens Council. Additionally, Mr. Jones was a past chairman of the Cystic Fibrosis Foundation Dallas and formerly served on the Baylor Healthcare System’s Board of Trustees.

ABOUT CROSSFIRST BANKSHARES

CrossFirst Bankshares, Inc. (Nasdaq: CFB) is a Kansas corporation and a registered bank holding company for its wholly owned subsidiary CrossFirst Bank, which is headquartered in Leawood, Kansas. CrossFirst Bank has eight full-service banking offices in Kansas, Missouri, Oklahoma and Texas. For more information on CrossFirst Bankshares, visit https://investors.crossfirstbankshares.com/investor-relations.

Investor Relations

Matt Needham
CrossFirst Bankshares, Inc.
913.312.6822
[email protected]
Media Contact

Meggin Nilssen
CrossFirst Bank
816.895.4604
[email protected]  



Scholar Rock Receives Fast Track Designation from the U.S. FDA for Apitegromab for the Treatment of Patients with Spinal Muscular Atrophy

Scholar Rock Receives Fast Track Designation from the U.S. FDA for Apitegromab for the Treatment of Patients with Spinal Muscular Atrophy

– Builds on Priority Medicines (PRIME) designation recently granted by the European Medicines Agency (EMA) recognizing the unmet medical needs of patients with SMA

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for apitegromab, a selective inhibitor of myostatin activation, for the treatment of patients with Spinal Muscular Atrophy (SMA). Fast Track designation is intended to facilitate the development and expedite the review of drugs to treat serious conditions and get new drugs to patients earlier. Through Fast Track, Scholar Rock is eligible to submit a rolling Biologic License Application (BLA) for apitegromab if relevant criteria are met.

“We are delighted to receive Fast Track designation and look forward to working closely with the FDA towards our aim of establishing apitegromab as the potential first muscle-directed therapy for patients with SMA,” said Tony Kingsley, President and CEO of Scholar Rock. “We believe the recently announced top-line data from the TOPAZ Phase 2 trial showed the transformative potential of apitegromab for patients with SMA.”

Fast Track is intended to fill an unmet medical need defined as providing a therapy where none exists or improving upon available therapies and is based on whether a drug will impact factors such as survival, day-to-day functioning, or if left untreated, progression to a more serious condition. In addition to Fast Track designation, apitegromab had previously received Orphan Drug and Rare Pediatric Disease designations from the FDA and PRIME and Orphan Medicinal Product designations from the EMA for the treatment of SMA.

“Recent Fast Track and PRIME designations granted by the regulatory agencies underscore the continuing unmet medical needs of patients with SMA,” said Yung Chyung, M.D., Chief Medical Officer of Scholar Rock. “The majority of non-ambulatory patients in our TOPAZ trial experienced increases in Hammersmith scores, highlighting the therapeutic potential of apitegromab to address motor function impairments in this patient population.”

About Apitegromab

Apitegromab is a selective inhibitor of the activation of myostatin and is an investigational product candidate for the treatment of patients with spinal muscular atrophy (SMA). Myostatin, a member of the TGFβ superfamily of growth factors, is expressed primarily by skeletal muscle cells, and the absence of its gene is associated with an increase in muscle mass and strength in multiple animal species, including humans. Scholar Rock believes that inhibiting myostatin activation with apitegromab may promote a clinically meaningful improvement in motor function in patients with SMA. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD), Orphan Drug designation (ODD) and Rare Pediatric Disease (RPD) designation, and the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation and Orphan Medicinal Product designation, to apitegromab for the treatment of SMA. The efficacy and safety of apitegromab have not been established and apitegromab has not been approved for any use by the FDA or any other regulatory agency.

About SMA

Spinal muscular atrophy (SMA) is a rare, and often fatal, genetic disorder that typically manifests in young children. An estimated 30,000 to 35,000 patients are afflicted with SMA in the United States and Europe. It is characterized by the loss of motor neurons, atrophy of the voluntary muscles of the limbs and trunk and progressive muscle weakness. The underlying pathology of SMA is caused by insufficient production of the SMN (survival of motor neuron) protein, essential for the survival of motor neurons, and is encoded by two genes, SMN1 and SMN2. While there has been progress in the development of therapeutics that address the underlying SMA genetic defect, via SMN-dependent pathways, there continues to be a high unmet need for therapeutics that directly address muscle atrophy.

About Scholar Rock

Scholar Rock is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative medicines for the treatment of serious diseases in which signaling by protein growth factors plays a fundamental role. Scholar Rock is creating a pipeline of novel product candidates with the potential to transform the lives of patients suffering from a wide range of serious diseases, including neuromuscular disorders, cancer, fibrosis and anemia. Scholar Rock’s newly elucidated understanding of the molecular mechanisms of growth factor activation enabled it to develop a proprietary platform for the discovery and development of monoclonal antibodies that locally and selectively target these signaling proteins at the cellular level. By developing product candidates that act in the disease microenvironment, the Company intends to avoid the historical challenges associated with inhibiting growth factors for therapeutic effect. Scholar Rock believes its focus on biologically validated growth factors may facilitate a more efficient development path. For more information, please visit www.ScholarRock.com or follow Scholar Rock on Twitter (@ScholarRock) and LinkedIn (https://www.linkedin.com/company/scholar-rock/).

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the potential of SRK-181, Scholar Rock’s future expectations, plans and prospects, including without limitation, Scholar Rock’s expectations regarding its growth, strategy, progress and timing of its clinical trials, the potential of its proprietary platform, and its intellectual property protection. The use of words such as “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify such forward-looking statements. All such forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include the possibility that data from the TOPAZ clinical trial will be inconsistent with the data observed in subsequent clinical trials, competition from third parties that are developing products for similar uses, Scholar Rock’s ability to obtain, maintain and protect its intellectual property, Scholar Rock’s dependence on third parties for development and manufacture of product candidates including to supply any clinical trials, Scholar Rock’s ability to manage expenses and to obtain additional funding when needed to support its business activities and establish and maintain strategic business alliances and new business initiatives, and the impacts of public health pandemics such as COVID-19 on business operations including its clinical trials, as well as those risks more fully discussed in the section entitled “Risk Factors” in Scholar Rock’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2021 as well as discussions of potential risks, uncertainties, and other important factors in Scholar Rock’s subsequent filings with the Securities and Exchange Commission. Any forward-looking statements represent Scholar Rock’s views only as of today and should not be relied upon as representing its views as of any subsequent date. All information in this press release is as of the date of the release, and Scholar Rock undertakes no duty to update this information unless required by law.

Investor Contact:

Catherine Hu

[email protected]

Media Contact:

Ariane Lovell

Finn Partners

[email protected]

917-565-2204

KEYWORDS: Massachusetts United States North America

INDUSTRY KEYWORDS: FDA Health Genetics General Health Pharmaceutical Biotechnology

MEDIA:

Logo
Logo

Longitudinal Study Finds One Medical’s Member-Based & Technology-Powered Primary Care Model Delivers Outsized Impact in Controlling Diabetes

Peer-reviewed study demonstrates significant improvement in glucose control and cholesterol levels among One Medical patients with previously uncontrolled diabetes

SAN FRANCISCO, May 24, 2021 (GLOBE NEWSWIRE) — Results of a longitudinal observational study to be published in JMIR Diabetes demonstrates how One Medical (Nasdaq: ONEM) incorporates an embedded diabetes management program within its membered-centered and technology-powered primary care model to deliver better health outcomes for patients, including meaningful reductions in HbA1c (blood glucose) levels.

Chronic disease burdens continue to rise, with diabetes and other chronic illnesses among the leading causes of death and disability in America. The CDC estimates that as of 2020, approximately 34 million Americans, just over 10% of the population, had diabetes. Through it’s human-centered and technology-powered model, One Medical seeks to address this public health concern by leveraging its multi-modal care strategy.

Study Findings

The peer-reviewed study is a retrospective observational analysis of a subset of One Medical patients with previously uncontrolled diabetes, and found that a cohort of 621 patients participating in One Medical’s diabetes management program saw significant improvements in glucose control and cholesterol levels. Using One Medical’s longitudinal primary care model, these patients saw their average HbA1c levels decrease by 19%, from 10.7% to 8.7%. This two point reduction is a significant improvement when compared to similar studies highlighting virtual-only solutions that did not include primary care to manage chronic care, and reported relatively modest improvements of up to 1 point. For context, previous studies have found that a one point reduction in HbA1c is linked to a reduction in risk of death by 21%, heart attacks by 14%, and microvascular complications by 37%.

One Medical incorporates chronic care management as an essential part of its member-based and technology-powered primary care services, with key features including the following:

  • Enhanced access to care through same and next-day in-office appointments with primary care providers, as well as 24/7 on-demand video chat and messaging, allowing issues and questions to be addressed as they arise
  • Self-management tools through the One Medical app, which provides care reminders and enables tracking of diabetes labs and blood pressure
  • A proprietary, built-for-purpose technology platform that allows One Medical providers to efficiently develop, document, and track a disease management plan
  • Population health analytics and outreach functions within its technology that remind both providers and patients to book follow-up visits, obtain labs, and seek disease-specific screenings

“Through One Medical’s modernized care model, which integrates 24/7 telehealth services with in-person care, we’re removing access barriers and making it easier for providers and patients to engage in managing chronic illnesses like diabetes,” said Lenny Lesser, MD, MSHS, Medical Director of Population Health at One Medical. “While some may think they need specialty services to properly manage their chronic health issues, chronic care management is actually a core component of One Medical’s modernized primary care model. Primary care providers are trained to manage chronic diseases through a whole person approach, by addressing behavioral health needs and lifestyle factors in addition to managing medications. If they are supported through a membership-oriented and technology-powered model, they can also drive significant improvements in outcomes.”

About One Medical:

One Medical is a membership-based and technology-powered primary care platform with seamless digital health and inviting in-office care, convenient to where people work, shop, live, and click. Our vision is to delight millions of members with better health and better care while reducing costs. Our mission is to transform health care for all through our human-centered, technology-powered model.

Headquartered in San Francisco, 1Life Healthcare, Inc. is the administrative and managerial services company for the affiliated One Medical physician-owned professional corporations that deliver medical services in-office and virtually. 1Life and the One Medical entities do business under the “One Medical” brand.

Media Contact:

Breanna Shirk
Senior PR Manager, One Medical
[email protected]        



Ziopharm Oncology to Participate in Upcoming Conferences

BOSTON, May 24, 2021 (GLOBE NEWSWIRE) — Ziopharm Oncology, Inc. (“Ziopharm” or the “Company”) (Nasdaq: ZIOP), a clinical-stage cellular therapy company focused on hematologic and solid tumor cancers, today announced that Company management will participate in two upcoming investor conferences:

The Jefferies Virtual Healthcare Conference, taking place June 1-4, 2021: Interim Chief Executive Officer Heidi Hagen and Chief Medical Officer Raffaele Baffa will participate in a fireside chat on June 4 at 1pm ET.

The Virtual Raymond James Human Health Innovations Conference, taking place June 21-23, 2021: Interim Chief Executive Officer Heidi Hagen will participate in a fireside chat on June 22 at 2:40pm ET.

Webcasts of the conference presentations will be available using links that will be posted on the Ziopharm website, www.ziopharm.com, in the Investor section.

About Ziopharm Oncology, Inc.

Ziopharm is a clinical stage biotech, developing non-viral and cytokine-driven cell and gene therapies that weaponize the body’s immune system to treat the millions of people globally diagnosed with cancer each year. Ziopharm’s pipeline is built for commercially scalable, cost effective T-cell receptor T-cell therapies based on its non-viral Sleeping Beauty gene transfer platform, and a rapidly manufactured Sleeping Beauty-enabled CD19-specific CAR-T program. The Company has clinical and strategic collaborations with leading public and private institutions including the National Cancer Institute and the University of Texas MD Anderson Cancer Center. For more information, please visit www.ziopharm.com.

Investor Relations Contact:

Adam D. Levy, Ph.D., MBA
EVP, Investor Relations and Corporate Communications
T: 508.552.9255
E: [email protected]



Exelixis Announces Phase 1b Results from Cohort 6 of COSMIC-021 Trial in Patients with Metastatic Castration-Resistant Prostate Cancer

Exelixis Announces Phase 1b Results from Cohort 6 of COSMIC-021 Trial in Patients with Metastatic Castration-Resistant Prostate Cancer

– The combination of cabozantinib and atezolizumab evaluated in cohort 6 of the COSMIC-021 phase 1b trial resulted in objective response rates of 27% and 18% per investigator assessment and Blinded Independent Radiology Committee, respectively –

– Exelixis intends to discuss the results with the U.S. FDA to determine next steps toward a regulatory submission for the combination regimen for patients with high-risk metastatic CRPC –

– Phase 3 CONTACT-02 trial underway for metastatic CRPC –

ALAMEDA, Calif.–(BUSINESS WIRE)–Exelixis, Inc. (NASDAQ: EXEL) today announced results from the metastatic castration-resistant prostate cancer (CRPC) cohort 6 of COSMIC-021, the phase 1b trial of cabozantinib (CABOMETYX®) in combination with atezolizumab in patients with locally advanced or metastatic solid tumors. Cohort 6 included patients with metastatic CRPC who had been previously treated with enzalutamide and/or abiraterone acetate.

Upon enrollment, patients had to have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v. 1.1) per investigator assessment, had progressed on prior novel hormonal therapy, and could have received prior docetaxel for hormone-sensitive disease. The analysis included 132 patients, 101 of whom had high-risk disease, defined as measurable visceral and/or extra-pelvic lymph node metastases. The group with high-risk disease is the patient population for which Exelixis would pursue a U.S. regulatory filing. The median follow-up for the high-risk patients was 15.8 months. The primary endpoint was investigator-assessed objective response rate (ORR) per RECIST v. 1.1.

In the high-risk population, the investigator-assessed ORR was 27%, including 2% complete responses (CR) and 25% partial responses (PR). The Blinded Independent Radiology Committee (BIRC)-assessed ORR was 18%, all of which were partial responses. The disease control rate (CR + PR + stable disease) was 88% and 84% per investigator and BIRC assessment, respectively. Other radiographic endpoints, namely progression-free survival and duration of response, were similar between the investigator and BIRC assessment. Detailed results of the trial will be presented at a medical meeting in the second half of 2021.

An interim analysis of the initial 44 patients enrolled in the cohort was previously presented at the 2020 American Society of Clinical Oncology Virtual Scientific Program.

“These results from cohort 6 of COSMIC-021 suggest cabozantinib in combination with atezolizumab holds promise as a potential new treatment option in metastatic castration-resistant prostate cancer, a difficult-to-treat tumor type that typically has a poor prognosis,” said Neeraj Agarwal, M.D., Professor of Medicine, Huntsman Cancer Institute, University of Utah and an investigator of the trial. “There is a significant need for more options beyond chemotherapy once patients progress on androgen-deprivation therapy, so it is encouraging to see the response rates, disease control and tolerable safety profile associated with cabozantinib in combination with atezolizumab in this trial.”

The adverse event profile observed in the study was reflective of the known safety profile for each single agent. No new safety signals were identified in this expanded combination cohort. Discontinuation of treatment due to adverse events unrelated to disease progression was 12%.

In continuation of prior regulatory interaction and feedback from the U.S. Food & Drug Administration (FDA), Exelixis intends to discuss the results with the FDA to determine next steps toward a regulatory submission for the combination regimen for patients with high-risk metastatic CRPC. The global phase 3 trial, CONTACT-02, initiated enrollment in June 2020 and is evaluating cabozantinib in combination with atezolizumab versus a second novel hormonal therapy in patients with metastatic CRPC who have been previously treated with one novel hormonal therapy.

“Many patients with metastatic castration-resistant prostate cancer who have progressed on a novel hormonal therapy wish to avoid or delay chemotherapy. These results of the COSMIC-021 cohort 6 suggest the combination of cabozantinib and atezolizumab may offer this patient population a new treatment option,” said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. “We look forward to building on these results with the phase 3 CONTACT-02 trial in our continued effort to bring cabozantinib to many more patients in need.”

More information about this trial (NCT03170960) is available at ClinicalTrials.gov.

About the COSMIC-021 Study

COSMIC-021 is a multicenter, phase 1b, open-label study that is divided into two parts: a dose-escalation phase and an expansion cohort phase. The dose-escalation phase was designed to enroll patients either with advanced renal cell carcinoma (RCC) with or without prior systemic therapy or with inoperable, locally advanced, metastatic or recurrent urothelial carcinoma (UC), (including renal, pelvis, ureter, urinary bladder and urethra) after prior platinum-based therapy. Ultimately, all 12 patients enrolled in this stage of the trial were patients with advanced RCC. The dose-escalation phase of the study determined the optimal dose of cabozantinib to be 40 mg daily when given in combination with atezolizumab (1200 mg infusion once every 3 weeks).

In the expansion phase, the trial is enrolling 24 cohorts in 12 tumor types: RCC, UC, non-small cell lung cancer (NSCLC), CRPC, hepatocellular carcinoma (HCC), triple-negative breast cancer, epithelial ovarian cancer, endometrial cancer, gastric or gastroesophageal junction adenocarcinoma, colorectal adenocarcinoma, head and neck cancer, and differentiated thyroid cancer.

Four of the cohorts are exploratory: three are enrolling approximately 30 patients each with advanced UC, CRPC or NSCLC to be treated with cabozantinib as a single-agent, and one is enrolling approximately 10 patients with advanced CRPC to be treated with single-agent atezolizumab. Exploratory cohorts have the option to be expanded up to 80 patients (cabozantinib) and 30 patients (atezolizumab) total.

Exelixis is the study sponsor of COSMIC-021. Both Ipsen Pharma SAS (Ipsen) and Takeda Pharmaceutical Company Limited (Takeda) have opted in to participate in the trial and are contributing to the funding for this study under the terms of the companies’ respective collaboration agreements with Exelixis. Roche is providing atezolizumab for the trial.

About CRPC

According to the American Cancer Society, in 2021, approximately 250,000 new cases of prostate cancer will be diagnosed, and 34,000 people will die from the disease.1 Prostate cancer that has spread beyond the prostate and does not respond to androgen-suppression therapies — a common treatment for prostate cancer — is known as metastatic CRPC.2 Researchers estimate that in 2020, 43,000 people were diagnosed with metastatic CRPC, which has a median survival of less than two years.3,4,5

About CABOMETYX® (cabozantinib)

In the U.S., CABOMETYX tablets are approved for the treatment of patients with advanced RCC; for the treatment of patients with HCC who have been previously treated with sorafenib; and for patients with advanced RCC as a first-line treatment in combination with nivolumab. CABOMETYX tablets have also received regulatory approvals in the European Union and additional countries and regions worldwide. In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the United States and Japan. In 2017, Exelixis granted exclusive rights to Takeda Pharmaceutical Company Limited for the commercialization and further clinical development of cabozantinib for all future indications in Japan. Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the United States.

CABOMETYX is not indicated as a treatment for metastatic CRPC.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hemorrhage: Severe and fatal hemorrhages occurred with CABOMETYX. The incidence of Grade 3 to 5 hemorrhagic events was 5% in CABOMETYX patients in RCC and HCC studies. Discontinue CABOMETYX for Grade 3 or 4 hemorrhage. Do not administer CABOMETYX to patients who have a recent history of hemorrhage, including hemoptysis, hematemesis, or melena.

Perforations and Fistulas: Fistulas, including fatal cases, occurred in 1% of CABOMETYX patients. Gastrointestinal (GI) perforations, including fatal cases, occurred in 1% of CABOMETYX patients. Monitor patients for signs and symptoms of fistulas and perforations, including abscess and sepsis. Discontinue CABOMETYX in patients who experience a Grade 4 fistula or a GI perforation.

Thrombotic Events: CABOMETYX increased the risk of thrombotic events. Venous thromboembolism occurred in 7% (including 4% pulmonary embolism) and arterial thromboembolism in 2% of CABOMETYX patients. Fatal thrombotic events occurred in CABOMETYX patients. Discontinue CABOMETYX in patients who develop an acute myocardial infarction or serious arterial or venous thromboembolic events that require medical intervention.

Hypertension and Hypertensive Crisis: CABOMETYX can cause hypertension, including hypertensive crisis. Hypertension was reported in 36% (17% Grade 3 and <1% Grade 4) of CABOMETYX patients. Do not initiate CABOMETYX in patients with uncontrolled hypertension. Monitor blood pressure regularly during CABOMETYX treatment. Withhold CABOMETYX for hypertension that is not adequately controlled with medical management; when controlled, resume at a reduced dose. Discontinue CABOMETYX for severe hypertension that cannot be controlled with anti-hypertensive therapy or for hypertensive crisis.

Diarrhea: Diarrhea occurred in 63% of CABOMETYX patients. Grade 3 diarrhea occurred in 11% of CABOMETYX patients. Withhold CABOMETYX until improvement to Grade 1 and resume at a reduced dose for intolerable Grade 2 diarrhea, Grade 3 diarrhea that cannot be managed with standard antidiarrheal treatments, or Grade 4 diarrhea.

Palmar-Plantar Erythrodysesthesia (PPE): PPE occurred in 44% of CABOMETYX patients. Grade 3 PPE occurred in 13% of CABOMETYX patients. Withhold CABOMETYX until improvement to Grade 1 and resume at a reduced dose for intolerable Grade 2 PPE or Grade 3 PPE.

Hepatotoxicity: CABOMETYX in combination with nivolumab can cause hepatic toxicity with higher frequencies of Grades 3 and 4 ALT and AST elevations compared to CABOMETYX alone.

Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes than when the drugs are administered as single agents. For elevated liver enzymes, interrupt CABOMETYX and nivolumab and consider administering corticosteroids.

With the combination of CABOMETYX and nivolumab, Grades 3 and 4 increased ALT or AST were seen in 11% of patients. ALT or AST >3 times ULN (Grade ≥2) was reported in 83 patients, of whom 23 (28%) received systemic corticosteroids; ALT or AST resolved to Grades 0-1 in 74 (89%). Among the 44 patients with Grade ≥2 increased ALT or AST who were rechallenged with either CABOMETYX (n=9) or nivolumab (n=11) as a single agent or with both (n=24), recurrence of Grade ≥2 increased ALT or AST was observed in 2 patients receiving CABOMETYX, 2 patients receiving nivolumab, and 7 patients receiving both CABOMETYX and nivolumab.

Adrenal Insufficiency: CABOMETYX in combination with nivolumab can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold CABOMETYX and/or nivolumab depending on severity.

Adrenal insufficiency occurred in 4.7% (15/320) of patients with RCC who received CABOMETYX with nivolumab, including Grade 3 (2.2%), and Grade 2 (1.9%) adverse reactions. Adrenal insufficiency led to permanent discontinuation of CABOMETYX and nivolumab in 0.9% and withholding of CABOMETYX and nivolumab in 2.8% of patients with RCC.

Approximately 80% (12/15) of patients with adrenal insufficiency received hormone replacement therapy, including systemic corticosteroids. Adrenal insufficiency resolved in 27% (n=4) of the 15 patients. Of the 9 patients in whom CABOMETYX with nivolumab was withheld for adrenal insufficiency, 6 reinstated treatment after symptom improvement; of these, all (n=6) received hormone replacement therapy and 2 had recurrence of adrenal insufficiency.

Proteinuria: Proteinuria was observed in 7% of CABOMETYX patients. Monitor urine protein regularly during CABOMETYX treatment. Discontinue CABOMETYX in patients who develop nephrotic syndrome.

Osteonecrosis of the Jaw (ONJ): ONJ occurred in <1% of CABOMETYX patients. ONJ can manifest as jaw pain, osteomyelitis, osteitis, bone erosion, tooth or periodontal infection, toothache, gingival ulceration or erosion, persistent jaw pain, or slow healing of the mouth or jaw after dental surgery. Perform an oral examination prior to CABOMETYX initiation and periodically during treatment. Advise patients regarding good oral hygiene practices. Withhold CABOMETYX for at least 3 weeks prior to scheduled dental surgery or invasive dental procedures, if possible. Withhold CABOMETYX for development of ONJ until complete resolution.

Impaired Wound Healing: Wound complications occurred with CABOMETYX. Withhold CABOMETYX for at least 3 weeks prior to elective surgery. Do not administer CABOMETYX for at least 2 weeks after major surgery and until adequate wound healing is observed. The safety of resumption of CABOMETYX after resolution of wound healing complications has not been established.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): RPLS, a syndrome of subcortical vasogenic edema diagnosed by characteristic findings on MRI, can occur with CABOMETYX. Evaluate for RPLS in patients presenting with seizures, headache, visual disturbances, confusion, or altered mental function. Discontinue CABOMETYX in patients who develop RPLS.

Embryo-Fetal Toxicity: CABOMETYX can cause fetal harm. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Verify the pregnancy status of females of reproductive potential prior to initiating CABOMETYX and advise them to use effective contraception during treatment and for 4 months after the last dose.

ADVERSE REACTIONS

The most common (≥20%) adverse reactions are:

CABOMETYX as a single agent: diarrhea, fatigue, decreased appetite, PPE, nausea, hypertension, vomiting, weight decreased, constipation, and dysphonia.

CABOMETYX in combination with nivolumab: diarrhea, fatigue, hepatotoxicity, PPE, stomatitis, rash, hypertension, hypothyroidism, musculoskeletal pain, decreased appetite, nausea, dysgeusia, abdominal pain, cough, and upper respiratory tract infection.

DRUG INTERACTIONS

Strong CYP3A4 Inhibitors: If coadministration with strong CYP3A4 inhibitors cannot be avoided, reduce the CABOMETYX dosage. Avoid grapefruit or grapefruit juice.

Strong CYP3A4 Inducers: If coadministration with strong CYP3A4 inducers cannot be avoided, increase the CABOMETYX dosage. Avoid St. John’s wort.

USE IN SPECIFIC POPULATIONS

Lactation: Advise women not to breastfeed during CABOMETYX treatment and for 4 months after the final dose.

Hepatic Impairment: In patients with moderate hepatic impairment, reduce the CABOMETYX dosage. Avoid CABOMETYX in patients with severe hepatic impairment.

Please see accompanying full Prescribing Information https://www.cabometyx.com/downloads/CABOMETYXUSPI.pdf.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

About Exelixis

Founded in 1994, Exelixis, Inc. (Nasdaq: EXEL) is a commercially successful, oncology-focused biotechnology company that strives to accelerate the discovery, development and commercialization of new medicines for difficult-to-treat cancers. Following early work in model system genetics, we established a broad drug discovery and development platform that has served as the foundation for our continued efforts to bring new cancer therapies to patients in need. Our discovery efforts have resulted in four commercially available products, CABOMETYX® (cabozantinib), COMETRIQ® (cabozantinib), COTELLIC® (cobimetinib) and MINNEBRO® (esaxerenone), and we have entered into partnerships with leading pharmaceutical companies to bring these important medicines to patients worldwide. Supported by revenues from our marketed products and collaborations, we are committed to prudently reinvesting in our business to maximize the potential of our pipeline. We are supplementing our existing therapeutic assets with targeted business development activities and internal drug discovery – all to deliver the next generation of Exelixis medicines and help patients recover stronger and live longer. Exelixis is a member of the Standard & Poor’s (S&P) MidCap 400 index, which measures the performance of profitable mid-sized companies. In November 2020, the company was named to Fortune’s 100 Fastest-Growing Companies list for the first time, ranking 17th overall and the third-highest biopharmaceutical company. For more information about Exelixis, please visit www.exelixis.com, follow @ExelixisInc on Twitter or like Exelixis, Inc. on Facebook.

Forward-Looking Statements

This press release contains forward-looking statements, including, without limitation, statements related to: the clinical and therapeutic potential of the combination of cabozantinib and atezolizumab as a treatment for patients with metastatic CRPC and the potential for the combination to be a new treatment option in the metastatic CRPC setting; Exelixis’ intention to discuss the results of Cohort 6 of COSMIC-021 with the FDA to determine next steps toward a regulatory submission for the combination of cabozantinib and atezolizumab for patients with high-risk metastatic CRPC; Exelixis’ plan to build on the results of Cohort 6 of COSMIC-021 with CONTACT-02 in an effort to bring cabozantinib to more patients in need; and Exelixis’ plans to reinvest in its business to maximize the potential of the company’s pipeline, including through targeted business development activities and internal drug discovery. Any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements and are based upon Exelixis’ current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation: complexities and the unpredictability of the regulatory review and approval processes in the U.S. and elsewhere; Exelixis’ and Roche’s continuing compliance with applicable legal and regulatory requirements; the potential failure of cabozantinib in combination with atezolizumab to demonstrate continued safety and efficacy in clinical testing; uncertainties inherent in the product development process; the costs of conducting clinical trials, including the ability or willingness of Exelixis’ collaboration partners to invest in the resources necessary to complete the trials; the continuing COVID-19 pandemic and its impact on Exelixis’ research and development operations; Exelixis’ dependence on third-party vendors for the development, manufacture and supply of cabozantinib; Exelixis’ ability to protect its intellectual property rights; market competition, including the potential for competitors to obtain approval for generic versions of CABOMETYX; changes in economic and business conditions; and other factors affecting Exelixis and its development programs discussed under the caption “Risk Factors” in Exelixis’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 6, 2021, and in Exelixis’ future filings with the SEC. All forward-looking statements in this press release are based on information available to Exelixis as of the date of this press release, and Exelixis undertakes no obligation to update or revise any forward-looking statements contained herein, except as required by law.

Exelixis, the Exelixis logo, CABOMETYX, COMETRIQ and COTELLIC are registered U.S. trademarks. MINNEBRO is a Japanese trademark.


1 American Cancer Society: Cancer Facts & Figures 2021. Available at: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2021/cancer-facts-and-figures-2021.pdf. Accessed May 2021.

2 American Society of Clinical Oncology. Cancer.Net. Treatment of Metastatic Castration-Resistant Prostate Cancer. September 8, 2014. Available at: https://www.cancer.net/research-and-advocacy/asco-care-and-treatment-recommendations-patients/treatment-metastatic-castration-resistant-prostate-cancer. Accessed May 2021.

3 Scher, H.I., Solo, K., Valant, J., Todd, M.B., Mehra, M. Prevalence of Prostate Cancer Clinical States and Mortality in the United States: Estimates Using a Dynamic Progression Model. PLOS ONE. 2015; 10: e0139440.

4 American Urological Association. Prostate Cancer: Castration Resistant Guideline. 2018. Available at: https://www.auanet.org/guidelines/prostate-cancer-castration-resistant-guideline. Accessed May 2021.

5 Moreira, D. M., Howard, L. E., Sourbeer, K. N., et al. Predicting Time From Metastasis to Overall Survival in Castration-Resistant Prostate Cancer: Results From SEARCH. Clin Genitourin Cancer. 2017; 15: 60–66.e2.

Investors Contact:

Susan Hubbard

EVP, Public Affairs and

Investor Relations

Exelixis, Inc.

(650) 837-8194

[email protected]

Media Contact:

Lindsay Treadway

Executive Director, Public Affairs

and Advocacy Relations

Exelixis, Inc.

(650) 837-7522

[email protected]

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Oncology Health General Health Radiology Clinical Trials Pharmaceutical Biotechnology

MEDIA:

Logo
Logo

Liquidia Announces Generic Treprostinil Injection Now Also Available for Subcutaneous Route of Administration

Sandoz Generic Treprostinil Injection now available for both routes of administration, subcutaneous and intravenous

MORRISVILLE, N.C., May 24, 2021 (GLOBE NEWSWIRE) — Liquidia Corporation (NASDAQ: LQDA) (“Liquidia” or the “Company”) today announced that Sandoz Treprostinil Injection, a generic form of Remodulin®, is now also available for subcutaneous (“SC”) administration to treat patients diagnosed with pulmonary arterial hypertension (“PAH”).

Sandoz Treprostinil Injection was the first fully-substitutable AP rated generic version of Remodulin. Both options for intravenous and SC administration of Sandoz generic Treprostinil Injection are now available at the same specialty pharmacy that dispenses the brand name medicine.

On May 21, 2021, Liquidia PAH’s manufacturing partner, Chengdu Shifeng Medical Technologies LTD (“Chengdu”) began selling the RG 3ml Medication Cartridge, which may be used to supply medications to PAH patients. Liquidia had previously announced the FDA’s clearance of Chengdu’s 510(k) supporting the use of the cartridge with the CADD-MS 3 pump manufactured by Smiths Medical, which has been used for the SC administration of Remodulin for more than 10 years.

Scott Moomaw, Liquidia’s Senior Vice President of Commercial, said: “We are excited to provide a new option in the parenteral use of Treprostinil Injection. Patients who need and depend on subcutaneously administered treprostinil will now, for the first time, have access to a lower cost generic treprostinil. Through our agreement with Sandoz, we will continue to provide the same level of high-touch support and services to our patients, but at a lower cost compared to the branded product.”

Since commercial launch two years ago, Sandoz Treprostinil Injection has only been used for intravenous administration. The cartridges required to operate the CADD-MS 3 pump were not available to patients using generic Treprostinil Injection due to restrictions imposed by other companies. The introduction of the RG 3ml Medication Cartridge has enabled the use of SC administration of Sandoz Treprostinil Injection for the first time.

Keren Haruvi, President, Sandoz Inc. said: “The FDA clearance of a path to bring additional new cartridges required for subcutaneous administration of this medicine means another option for patients who need access to this life-enhancing pulmonary arterial hypertension medicine. Sandoz has a strong track record for manufacturing high-quality generic medicines and supplying them reliably to the patients who need them.”

Remodulin® (treprostinil) is a registered trademark of United Therapeutics Corporation.
CADD-MS® 3 is a registered trademark of Smiths Medical ASD, Inc.

About Treprostinil Injection

Treprostinil Injection is the first-to-file, fully substitutable generic treprostinil for parenteral administration. Treprostinil Injection contains the same active ingredient, same strengths, same dosage form and same inactive ingredients as Remodulin® (treprostinil), and is offered to patients and physicians with the same level of service and support, but at a lower price than the branded drug. Liquidia PAH promotes the appropriate use of Treprostinil Injection for the treatment of PAH in the United States in partnership with Sandoz, Inc., who holds the Abbreviated New Drug Application (ANDA) with the FDA.

About Liquidia Corporation

Liquidia Corporation is a biopharmaceutical company focused on the development and commercialization of products in pulmonary hypertension and other applications of its PRINT technology. The Company operates through its two wholly owned subsidiaries, Liquidia Technologies, Inc. and Liquidia PAH, LLC. Liquidia Technologies is developing LIQ861, an inhaled dry powder formulation of treprostinil for the treatment of PAH. Liquidia PAH provides the commercialization for rare disease pharmaceutical products, such as Sandoz Treprostinil Injection.

Cautionary Statements Regarding Forward-Looking Statements

This press release may include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical facts, including statements regarding our future results of operations and financial position, our strategic and financial initiatives, our business strategy and plans and our objectives for future operations, are forward-looking statements. Such forward-looking statements, including statements regarding clinical trials, clinical studies and other clinical work (including the funding therefor, anticipated patient enrollment, safety data, study data, trial outcomes, timing or associated costs), regulatory applications and related submission contents and timelines, including our response to the Complete Response Letter received in November 2020, the potential for eventual FDA approval of the NDA for LIQ861, the timeline or outcome related to our patent litigation pending in the U.S. District Court for the District of Delaware or our inter partes review with the PTAB, the issuance of patents by the USPTO and our ability to execute on our strategic or financial initiatives, involve significant risks and uncertainties and actual results could differ materially from those expressed or implied herein. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives and financial needs. These forward-looking statements are subject to a number of risks discussed in our filings with the SEC, including the impact of the coronavirus (COVID-19) outbreak on our Company and our financial condition and results of operations, as well as a number of uncertainties and assumptions. Moreover, we operate in a very competitive and rapidly changing environment and our industry has inherent risks. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the future events discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Nothing in this press release should be regarded as a representation by any person that these goals will be achieved, and we undertake no duty to update our goals or to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact Information

Media & Investors:

Jason Adair
Vice President, Corporate Development and Strategy
919.328.4400
[email protected]



Electromed, Inc. Named 2021 Quality Plant of the Year

Electromed, Inc. Named 2021 Quality Plant of the Year

NEW PRAGUE, Minn.–(BUSINESS WIRE)–
Electromed, Inc. (NYSE American: ELMD) was named Quality Magazine’s 2021 Plant of the Year.

Electromed was selected for the honor from the 2021 Quality Leadership Top 100 Company survey published annually by the magazine. The metrics measure and showcase quality leadership such as: continuous improvement and internal quality programs; contribution of quality to profitability and shareholder value; average number of hours that employees receive quality training; scrap and rework as a percentage of sales; warranty costs as a percentage of sales; and registration to various standards such as ISO 9001. Electromed is certified to ISO 13485, used by organizations involved in the design, production, installation and servicing of medical devices. The Company has qualified as a top 10 company in the Quality Leadership Top 100 survey three of the last four years.

“We are so excited to be named as Quality Magazine’s 2021 Plant of the Year as this is a great honor for all of our team members and highlights their unwavering passion for patients, one of our core values,” said Kathleen Skarvan, President and Chief Executive Officer. “When you talk to our team members throughout the organization, you will hear a recurring theme: it feels good knowing that what we do makes a difference in a person’s life. With that engagement comes a recognition of the importance of delivering high quality services and a high-quality product.”

The full article, and a podcast can be found at https://bit.ly/2QpamO0.

About Electromed, Inc.

Electromed manufactures, markets, and sells products that provide airway clearance therapy, including the SmartVest® Airway Clearance System, to patients with compromised pulmonary function. The Company is headquartered in New Prague, Minnesota and was founded in 1992. Further information about Electromed can be found at www.smartvest.com.

Kathleen Skarvan

President and Chief Executive Officer

[email protected]

952-758-9299

KEYWORDS: United States North America Minnesota

INDUSTRY KEYWORDS: Public Policy/Government Health Healthcare Reform Medical Devices Consumer Seniors General Health

MEDIA:

Logo
Logo

Allied Esports Entertainment Announces First Quarter 2021 Financial Results

Allied Esports Entertainment Announces First Quarter 2021 Financial Results

IRVINE, Calif.–(BUSINESS WIRE)–Allied Esports Entertainment, Inc. (NASDAQ: AESE) (the “Company” or “AESE”), a global esports entertainment company, today announced financial results for the first quarter ended March 31, 2021, as well as an update on several key business initiatives. This release refers to “continuing” and “discontinued” operations due to the pending sale of the Company’s subsidiaries owning and operating its poker-related business, the World Poker Tour® (“World Poker Tour,” or “WPT®”), which is expected to close in the second or third quarter of 2021. Therefore, unless otherwise noted, results presented in this release relate to the continuing operations of the Company and Allied Esports, and excludes the World Poker Tour, which is classified as discontinued operations.

Commenting on the first quarter 2021 results, the Company’s CEO, Frank Ng, said, “Overall, I am pleased with the first quarter performance of our Esports business despite the headwinds and operational constraints we continue to face within the In-person pillar of our business as we slowly emerge from the COVID-19 pandemic. While In-person events were the primary growth drivers of our Esports revenue prior to the pandemic, I have been impressed with our team’s ability to pivot towards remote content creation and online events and adapt to the challenges posed by the pandemic. In doing so, we have made good progress over the last several quarters building out capabilities for the Multiplatform Content pillar of our Esports business, which has culminated in announcements this month of a new nine-month esports tournament program with Tencent’s streaming platform, as well as our first distribution partnership with MuxIP, which will result in the airing of hundreds of hours of our content library on OTT platforms. In addition, we further reduced our debt burden by paying off our convertible debt balance and in turn, significantly enhanced our capital structure while improving our financial flexibility and liquidity position. Looking forward, we believe that the strategic pivot we made accelerates our ability to further monetize aspects of the Esports ecosystem and take advantage of significant growth opportunities as the economy continues to improve and the environment normalizes.”

First Quarter 2021 Financial Results

Revenues: Total revenues of $0.5 million decreased 53% in the first quarter of 2021 compared to the first quarter of 2020. This was due to decreased In-person revenue as a result of the pandemic.

Costs and expenses: Total costs and expenses for the first quarter of 2021 were $5.4 million, a decrease of 43% compared to the first quarter of 2020. Costs and expenses decreased primarily due to lower expenses in the In-person pillar, and lower general and administrative, selling and marketing and stock-based compensation expenses.

Loss from continuing operations for the quarter was $5.0 million, compared to a loss of $9.1 million in the prior year period. The improvement was driven by lower costs and expenses for the current quarter.

Adjusted EBITDA loss was $3.3 million for the 2021 first quarter, as compared to $3.5 million in the first quarter of 2020. A reconciliation of the GAAP-basis net loss to adjusted EBITDA is provided in the table at the end of this press release.

Balance Sheet

As of March 31, 2021, the Company had a cash position of $18.5 million, including $5.0 million of restricted cash and $2.9 million of cash in connection with the WPT business that is included in current assets of discontinued operations, but is available to fund the Allied Esports business until the close of the WPT sale transaction. The Company had a cash position of $9.4 million at March 31, 2020, which included $5.0 million of restricted cash and $3.5 million held at WPT. The total gross principal amount of bridge and convertible debt as of March 31, 2021 was $3.4 million, as compared to $4.0 million as of December 31, 2020. As of March 31, 2021, the Company’s common shares outstanding totaled approximately 39.2 million shares.

Operational Update

Allied Esports

During the first quarter, the Company announced the renewal of its naming rights partnership with HyperX for the global flagship property at the Luxor Hotel and Casino in Las Vegas. As part of the renewal agreement, HyperX will continue to receive prominent branding and signage inside and outside of the venue, as well as across all arena promotions, content and social media platforms. HyperX and Allied Esports will continue to partner on a variety of co-branded experiences and events at the arena focused on growing their respective gaming and esports communities.

In the first quarter of 2021, Allied Esports produced 36 events, including 33 proprietary events and three third-party productions, across its North American and European business units.

During the current quarter, Allied Esports continued to see strong demand in both its in-arena and online proprietary offerings. Over 1,700 players competed in Allied Esports tournaments during the quarter, with events taking place online, in-arena and on the Allied Esports Truck.

Allied Esports continued to leverage its infrastructure for production services for several clients, including FaceIT, who has leveraged the HyperX Esports Arena as a COVID-19-safe bubble environment for participating teams in consecutive seasons of the Rainbow Six Siege North American League.

The Company also hosted its 2021 debut event on its Allied Esports Truck in the first quarter. The three-day event took place at Brookfield Properties’ First Colony Mall in Sugarland, Texas and served as an attraction for mall-goers and esports enthusiasts alike.

Allied Esports continued to gain traction with its 24-hour content strategy, which generated approximately 4.7 million live views on live streaming platforms in the first quarter, an increase of 59% compared to the fourth quarter of 2020, as well as a 21% sequential increase in followers across its Twitch and YouTube channels. At the end of the current quarter, Allied Esports ranked in the top 0.03% of all Twitch channels according to TwitchTracker.com, which ranks channels based on average viewers, followers, views and stream time during the most recent 30-day period.

Subsequent to the end of the first quarter 2021, Allied Esports announced that the Company has been selected by Trovo, an interactive live streaming platform, to create and produce a new community esports tournament series for gamers in North America, Latin America and Europe that will run throughout 2021. The Trovo Titans program, featuring over 100 events and 280 days of competition through weekly matches and monthly tournaments, will distribute $250,000 in prize pools for participants, plus additional incentives and rewards for viewers.

Corporate Developments

On March 22, 2021, the Company announced an amended definitive agreement to sell its subsidiaries operating the World Poker Tour, to Element Partners, LLC, subject to closing conditions, with a total transaction value of approximately $90.5 million.

In response to an unsolicited proposal from Bally’s Corporation to acquire the World Poker Tour for $105 million, and as announced on March 29, 2021, Element and the Company further amended their definitive agreement to increase the purchase price to $105 million, which the Company has accepted, and the parties amended their existing purchase agreement to reflect the updated terms. A preliminary proxy statement detailing the transaction and seeking the approval of the transaction by the Company’s stockholders was filed with the SEC on May 14, 2021. Subject to customary closing conditions, the Company anticipates closing the transaction in late second quarter or early third quarter of 2021.

First Quarter 2021 Conference Call

The Company will host a conference call today at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss its first quarter 2021 financial results. Participants may join the conference call by dialing 1-855-327-6837 (United States) or 1-631-891-4304 (International).

A live webcast of the conference call will also be available on the Company’s Investor Relations site at http://ir.alliedesportsent.com. Additionally, financial information presented on the call will be available on Allied Esports’ Investor Relations site. For those unable to participate in the conference call, a telephonic replay of the call will also be available shortly after the completion of the call, until 11:59 p.m. ET on Monday, June 7, 2021, by dialing 1-844-512-2921 (United States) or 1-412-317-6671 (International) and entering the replay pin number: 10014718.

About Allied Esports Entertainment

Allied Esports Entertainment (NASDAQ: AESE) is a global esports entertainment venture dedicated to providing transformative live experiences, multiplatform content and interactive services to audiences worldwide through its strategic fusion of two powerful entertainment brands: Allied Esports and the World Poker Tour (WPT). On January 19, 2021, AESE entered into a Stock Purchase Agreement (the “Original Agreement”) to sell the equity interests that own WPT to Element Partners, LLC once all applicable shareholder and regulatory consents have been obtained, and the other conditions to closing have been satisfied. The Original Agreement was amended and restated on March 22, 2021, and further amended on March 30, 2021 (the “Amended Agreement”). The foregoing transaction is referred to as the “Sale Transaction.”

Non-GAAP Financial Measures

As a supplement to our financial measures presented in accordance with U.S. Generally Accepted Accounting Principles (“GAAP”), the Company presents certain non-GAAP measures of financial performance. These non-GAAP financial measures are not intended to be considered in isolation from, as a substitute for, or as more important than, the financial information prepared and presented in accordance with GAAP. In addition, these non-GAAP measures have limitations in that they do not reflect all of the items associated with the company’s results of operations as determined in accordance with GAAP.

The Company provides net income (loss) and earnings (loss) per share in accordance with GAAP. In addition, the Company provides EBITDA (defined as GAAP net income (loss) from continuing operations before interest (income) expense, income taxes, depreciation, and amortization). The Company defines “Adjusted EBITDA” as EBITDA excluding certain non-cash charges, including extinguishment losses, stock-based compensation, inducement expense and impairment losses.

In the future, the Company may also consider whether other items should also be excluded in calculating the non-GAAP financial measures used by the Company. Management believes that the presentation of these non-GAAP financial measures provides investors with additional useful information to measure the Company’s financial and operating performance. In particular, the measures facilitate comparison of operating performance between periods and help investors to better understand the operating results of the Company by excluding certain items that may not be indicative of the Company’s core business, operating results, or future outlook. Additionally, we consider quantitative and qualitative factors in assessing whether to adjust for the impact of items that may be significant or that could affect an understanding of our ongoing financial and business performance or trends. Internally, management uses these non-GAAP financial measures, along with others, in assessing the Company’s operating results, and measuring compliance with the requirements of the Company’s debt financing agreements, as well as in planning and forecasting.

The Company’s non-GAAP financial measures are not based on a comprehensive set of accounting rules or principles, and our non-GAAP definitions of the “EBITDA” and “adjusted EBITDA” do not have a standardized meaning. Therefore, other companies may use the same or similarly named measures, but include or exclude different items, which may not provide investors a comparable view of the Company’s performance in relation to other companies.

Management compensates for the limitations resulting from the exclusion of these items by considering the impact of the items separately and by considering the Company’s GAAP, as well as non-GAAP, results and outlook, and by presenting the most comparable GAAP measures directly ahead of non-GAAP measures, and by providing a reconciliation that indicates and describes the adjustments made.

Forward Looking Statements

This communication contains certain forward-looking statements under federal securities laws. Forward-looking statements may include our statements regarding our goals, beliefs, strategies, objectives, plans, including product and service developments, future financial conditions, results or projections or current expectations. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential” or “continue,” the negative of such terms, or other comparable terminology. For example, when we discuss the impacts of the Sale Transaction, the satisfaction of the closing conditions to the Sale Transaction, the timing of the completion of the Sale Transaction; and our plans following the Sale Transaction, we are using forward-looking statements. These statements are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause actual results to be materially different from those contemplated by the forward-looking statements. These factors include, but are not limited to, the occurrence of any event, change or other circumstances that could give rise to the termination of the Amended Agreement or could otherwise cause the Sale Transaction to fail to close; the outcome of any legal proceedings that may be instituted against us following the announcement of the Sale Transaction; the inability to complete the Sale Transaction, including due to failure to obtain approval of our stockholders or other conditions to closing; the receipt of an unsolicited offer from another party for an alternative business transaction that could interfere with the Sale Transaction; a change in our plans to retain the net cash proceeds from the Sale Transaction; our inability to enter into one or more future acquisition or strategic transactions using the net proceeds from the Sale Transaction; and a decision not to pursue strategic options for the esports business. Most of these factors are difficult to predict accurately and are generally beyond our control. You should consider the areas of risk described in connection with any forward-looking statements that may be made herein. The business and operations of AESE are subject to substantial risks, which increase the uncertainty inherent in the forward-looking statements contained in this communication. Except as required by law, we undertake no obligation to release publicly the result of any revision to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Further information on potential factors that could affect our business is described under “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the SEC on April 13, 2021. Readers are also urged to carefully review and consider the various disclosures we made in such amended Annual Report on Form 10-K and the preliminary Proxy Statement with respect to the proposed Sale Transaction that we have filed with the SEC, and the Proxy Statement that we will mail to our stockholders.

Important Additional Information and Where You Can Find It

AESE has filed with the SEC a preliminary Proxy Statement in connection with the transactions contemplated by the Amended Agreement, and will file and mail to its stockholders a definitive Proxy Statement with regards to the Amended Agreement and Sale Transaction. The Proxy Statement contains important information about AESE, Club Services, Inc., the Sale Transaction and the Amended Agreement. Investors and stockholders are urged to read the Proxy Statement and the supplemental materials carefully before making any decision to invest or approve of the Sale Transaction. Investors and stockholders will be able to obtain free copies of the Proxy Statement, supplemental materials and other documents filed by AESE with the SEC through the website maintained by the SEC at www.sec.gov or may contact AESE’s solicitor, Regan & Associates, Inc., by telephone (toll-free within North America) at 1-800-737-3426.

Participants in the Solicitation

In addition to Regan & Associates, Inc., AESE, its directors and executive officers may be deemed to be participants in the solicitation of consents with respect to the Sale Transaction. Information regarding AESE’s directors and executive officers and their ownership of AESE shares is contained in AESE’s Annual Report on Form 10-K for the year ended December 31, 2020 and its Proxy Statement for the Sale Transaction which was filed with the SEC on May 14, 2021, and is supplemented by other public filings made, and to be made, with the SEC. AESE’s directors and executive officers beneficially own approximately 42.3% of AESE’s common stock. Investors and stockholders may obtain additional information regarding the direct and indirect interests of AESE and its directors and executive officers with respect to the Sale Transaction by reading the Proxy Statement and other filings referred to above.

Allied Esports Entertainment, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
 
March 31, December 31,

 

2021

 

 

2020

 

(unaudited)
Assets
Current Assets
Cash

$

10,543,015

 

$

424,223

 

Restricted cash

 

5,000,000

 

 

5,000,000

 

Accounts receivable

 

62,297

 

 

271,142

 

Prepaid expenses and other current assets

 

618,876

 

 

909,766

 

Current assets held for sale

 

47,286,263

 

 

45,363,817

 

Total Current Assets

 

63,510,451

 

 

51,968,948

 

Property and equipment, net

 

8,386,189

 

 

9,275,729

 

Intangible assets, net

 

29,820

 

 

30,818

 

Deposits

 

625,000

 

 

625,000

 

Total Assets

$

72,551,460

 

$

61,900,495

 

Liabilities and Stockholders’ Equity
Current Liabilities
Accounts payable

$

1,090,025

 

$

901,353

 

Deposit for sale of WPT

 

10,000,000

 

 

 

Accrued expenses and other current liabilities

 

2,254,191

 

 

1,987,017

 

Accrued interest, current portion

 

256,249

 

 

152,899

 

Due to affiliates

 

11,968,377

 

 

9,433,975

 

Deferred revenue

 

98,903

 

 

57,018

 

Bridge note payable

 

1,421,096

 

 

1,421,096

 

Convertible debt, net of discount, current portion

 

1,000,000

 

 

1,000,000

 

Convertible debt, related party, net of discount, current portion

 

1,000,000

 

 

1,000,000

 

Loans payable, current portion

 

814,960

 

 

539,055

 

Current liabilities held for sale

 

9,248,465

 

 

9,169,247

 

Total Current Liabilities

 

39,152,266

 

 

25,661,660

 

Deferred rent

 

1,827,909

 

 

1,693,066

 

Accrued interest, non-current portion

 

 

 

193,939

 

Convertible debt, net of discount, non-current portion

 

 

 

578,172

 

Loans payable, non-current portion

 

92,169

 

 

368,074

 

Total Liabilities

 

41,072,344

 

 

28,494,911

 

Commitments and Contingencies
Stockholders’ Equity
Preferred stock, $0.0001 par value, 1,000,000 shares authorized,
none issued and outstanding

 

 

 

 

Common stock, $0.0001 par value; 100,000,000 shares authorized,
39,162,811 and 38,506,844 shares issued and outstanding
at March 31, 2021 and December 31, 2020, respectively

 

3,917

 

 

3,851

 

Additional paid in capital

 

196,872,987

 

 

195,488,181

 

Accumulated deficit

 

(165,614,090

)

 

(162,277,414

)

Accumulated other comprehensive income

 

216,302

 

 

190,966

 

Total Stockholders’ Equity

 

31,479,116

 

 

33,405,584

 

Total Liabilities and Stockholders’ Equity

$

72,551,460

 

$

61,900,495

 

Allied Esports Entertainment, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations and Comprehensive Loss
(unaudited)
 
For the Three Months Ended
March 31,

 

2021

 

 

2020

 

 
Revenues:
In-person

$

501,028

 

$

1,057,741

 

Total Revenues

 

501,028

 

 

1,057,741

 

Costs and Expenses:
In-person (exclusive of depreciation and amortization)

 

537,867

 

 

987,443

 

Online operating expenses

 

40,319

 

 

61,707

 

Selling and marketing expenses

 

43,934

 

 

75,727

 

General and administrative expenses

 

3,229,555

 

 

3,453,097

 

Stock-based compensation

 

643,148

 

 

3,946,786

 

Depreciation and amortization

 

881,959

 

 

899,097

 

Total Costs and Expenses

 

5,376,782

 

 

9,423,857

 

Loss From Operations

 

(4,875,754

)

 

(8,366,116

)

Other Income (Expense):
Other income (expense), net

 

55,142

 

 

(2,202

)

Interest expense

 

(153,106

)

 

(682,940

)

Total Other Expense

 

(97,964

)

 

(685,142

)

Loss from continuing operations

 

(4,973,718

)

 

(9,051,258

)

Income from discontinued operations, net of tax provision

 

1,637,042

 

 

274,789

 

Net loss

$

(3,336,676

)

$

(8,776,469

)

 
Basic and Diluted Net (Loss) Income per Common Share
Continuing operations

$

(0.13

)

$

(0.38

)

Discontinued operations, net of tax

$

0.04

 

$

0.01

 

 
Weighted Average Number of Common Shares Outstanding:
Basic and Diluted

 

38,522,107

 

 

23,818,144

 

 
Comprehensive Loss
Net Loss

 

(3,336,676

)

 

(8,776,469

)

Other comprehensive income:
Foreign currency translation adjustments

 

25,336

 

 

 

Total Comprehensive Loss

$

(3,311,340

)

$

(8,776,469

)

World Poker Tour
Assets and Liabilities of Discontinued Operations
(Unaudited)
 
March 31, December 31,

 

2021

 

2020

Assets
Cash

$

2,917,217

$

3,633,292

Accounts receivable

 

2,009,129

 

1,804,627

Prepaid expenses and other assets

 

255,843

 

289,968

Property and equipment, net

 

1,554,769

 

1,674,355

Goodwill

 

4,083,621

 

4,083,621

Intangible assets, net

 

11,690,264

 

12,305,887

Deposits

 

79,500

 

79,500

Deferred production costs

 

12,727,543

 

12,058,592

Due from affiliates

 

11,968,377

 

9,433,975

Current assets held for sale

$

47,286,263

$

45,363,817

 
Liabilities
Accounts payable

$

504,801

$

211,228

Accrued expenses and other liabilities

 

3,858,076

 

3,804,301

Accrued interest

 

 

4,224

Deferred revenue

 

2,278,172

 

1,970,668

Deferred rent

 

2,607,416

 

2,493,526

Loans payable

 

 

685,300

Current liabilities held for sale

$

9,248,465

$

9,169,247

 
World Poker Tour
Results of Discontinued Operations
(Unaudited)
 
For the Three Months Ended
March 31,

 

2021

 

2020

 
Revenues

$

5,334,010

$

4,987,312

Operating costs and expenses

 

4,386,493

 

4,715,266

Income from operations

 

947,517

 

272,046

Other income

 

689,525

 

2,743

Net income from discontinued operations, before tax

 

1,637,042

 

274,789

Income tax

 

 

Income (loss) from discontinued operations, net of tax provision

$

1,637,042

$

274,789

RECONCILIATION OF GAAP NET LOSS TO ADJUSTED EBITDA

(Unaudited)

EBITDA and Adjusted EBITDA are non-GAAP financial measures and should not be considered as a substitute for net income (loss), operating income (loss) or any other performance measure derived in accordance with United States generally accepted accounting principles (“GAAP”) or as an alternative to net cash provided by operating activities as a measure of AESE’s profitability or liquidity. AESE’s management believes EBITDA and Adjusted EBITDA are useful because they allow external users of its financial statements, such as industry analysts, investors, lenders and rating agencies, to more effectively evaluate its operating performance, compare the results of its operations from period to period and against AESE’s peers without regard to AESE’s financing methods, hedging positions or capital structure and because it highlights trends in AESE’s business that may not otherwise be apparent when relying solely on GAAP measures. AESE presents EBITDA and Adjusted EBITDA because it believes EBITDA and Adjusted EBITDA are important supplemental measures of its performance that are frequently used by others in evaluating companies in its industry. Because EBITDA and Adjusted EBITDA exclude some, but not all, items that affect net income (loss) and may vary among companies, the EBITDA and Adjusted EBITDA AESE presents may not be comparable to similarly titled measures of other companies. AESE defines “EBITDA” as loss from continuing operations before interest, income taxes, depreciation and amortization of intangibles. AESE defines “Adjusted EBITDA” as EBITDA excluding certain non-cash charges, including extinguishment losses, stock-based compensation, inducement expense and impairment losses.

The following table presents a reconciliation of EBITDA and Adjusted EBITDA from net loss from continuing operations, AESE’s most directly comparable financial measure calculated and presented in accordance with GAAP.

Three Months Ended
March 31,
 

 

2021

 

 

2020

 

Continuing operations
Net loss from continuing operations

$

(4,973,718

)

$

(9,051,258

)

Interest expense, net

 

153,106

 

 

682,940

 

Federal, state, and foreign taxes

 

 

 

43

 

Depreciation and amortization

 

881,959

 

 

899,097

 

EBITDA

 

(3,938,653

)

 

(7,469,178

)

Stock compensation

 

643,148

 

 

3,946,786

 

Adjusted EBITDA

$

(3,295,505

)

$

(3,522,392

)

 

Investor Contact:

Lasse Glassen

Addo Investor Relations

[email protected]

424-238-6249

Media Contact:

Brian Fisher

Allied Esports Entertainment

[email protected]

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Entertainment Sports Other Entertainment Other Sports General Entertainment Casino/Gaming

MEDIA:

Logo
Logo

Beam Global Reports Fiscal Q1 2021 Financial Results

Conference Call Today at 4:30 PM ET

SAN DIEGO, May 24, 2021 (GLOBE NEWSWIRE) — Beam Global, (Nasdaq: BEEM, BEEMW) (“Beam” or “the Company”), the leading provider of innovative sustainable technology for electric vehicle (EV) charging, outdoor media and energy security, today announced financial results for the fiscal first quarter ended March 31, 2021.

First Quarter and Recent Company Highlights

  • Current Contracted Backlog exceeds $5M.
  • Operating capital of $30M – historic high. No debt.
  • California places largest order in the Company’s history. The California Department of General Services (DGS) placed an order for 52 EV ARC™ solar-powered EV charging systems that will expand access to sustainable EV charging and emergency power for 12 state government agencies. This is the largest order in the Company’s history.
  • Electrify America deploys Jeep branded EV ARC™ in support of the Jeep 4xe off-grid, renewably energized charging network for off-road environments.
  • Orders received from Federal agencies through recently awarded GSA contract.
  • EV ARC™ systems deployed for municipalities, education, enterprise and utility customers.
  • The City of San Diego deployed EV ARCTM solar-powered charging systems to fuel the city’s growing fleet of electric vehicles and provide emergency preparedness assets. Press event/ribbon cutting with Mayor Gloria and two EV ARC™ systems charging 10 Chevy Bolts simultaneously.
  • Press event/ribbon cutting with Mayor of Olathe, Kansas announcing the deployment of 6 EV ARC™ systems for public and city vehicle use. First EV ARC™ deployment in Kansas.
  • A global entertainment brand deployed the first EV ARC™ system to power on-location film production equipment and electric vehicles.
  • Solar Tree® delivery for full size electric buses in California.

“Our current contracted backlog, combined with YTD revenue already exceeds our 2020 revenues, our pipeline is near historic highs and we still have seven months of selling left in 2021,” said Beam CEO Desmond Wheatley. “We believe that a combination of federal, state and local spending on EV charging infrastructure, combined with an increase in workplace charging with a return to the office, post vaccine in the second half, will create a level of demand for our products we have not previously experienced. An increased awareness of the importance of rapidly deployed, construction-free EV charging infrastructure, which is renewably energized and immune to blackouts, favors our differentiators and we are seeing this both from Government and enterprise. 2021 is shaping up to be an excellent year for Beam Global.”

Fiscal Q1 2021 Financial Summary

Revenues

Our revenues for the first fiscal quarter ended March 31, 2021 were $1,372,392, compared to $1,317,052 for the same period in the prior year, a 4% increase. As in the past, our shipments to municipalities continued strong, and we also shipped systems into federal, academic, utility and enterprise segments. This included the sale of a unit to Jeep, a Stellantis brand, and one to their partner Electrify America, both for use in the Moab, UT launch of their Jeep 4xe Charging Network to provide EV charging at Jeep Badge of Honor off-road trailheads throughout the U.S. By comparison, revenues in the first quarter of 2020 were heavily concentrated on state and local municipalities in several cities across the U.S.

Gross Loss

The gross loss for the three months ended March 31, 2021 was $149,120 compared to a gross loss of $39,641 for the same period in 2020. Our gross loss increased primarily due to an increase in costs for the new EV ARC™ 2020 unit that was launched at the end of 2019 and rolled out in 2020, compared to the original EV ARC™. As we’ve previously experienced, the initial costs of a new product start out high and then improve over time as a result of improvements to the production process and the reduction of material costs. We expect our margins to improve as we increase our production levels, which will reduce our overhead costs per unit and improve our labor efficiency.

Operating Expenses

Total operating expenses were $1,102,675 for the three months ended March 31, 2021, compared to $902,000 for the same period in 2020, a 22% increase. The increase was primarily due to $85,875 for non-cash compensation expense for stock option expense and vesting of director restricted shares, $51,605 for increased sales headcount to support revenue growth, $29,241 for R&D increased headcount to support development projects and other net increases.

Net Loss

The net loss for the first quarter of 2021 was $1,250,809, compared to $942,521 for the first quarter of 2020. This is primarily attributable to the increase in gross loss and increased operating expenses.

Cash and Working Capital

At March 31, 2021, we had cash of $28,214,029, compared to $26,702,804 at December 31, 2020. The increase resulted from the exercise of warrants, partially offset by cash used in operations. Our working capital increased from $28,063,320 to $29,507,478 from December 31, 2020 to March 31, 2021.

Conference Call Today at 4:30 PM ET

Management will host a conference call today at 4:30 PM ET to review financial results and provide an update on corporate developments. Following management’s formal remarks, there will be a question-and-answer session.

Participants can register for the conference through the following link:  
https://dpregister.com/sreg/10156949/e8d906c5f6
Please note that registered participants will receive their dial in number upon registration.

Those without internet access or unable to pre-register may dial in by calling:
PARTICIPANT DIAL IN (TOLL FREE):         1-844-739-3880
PARTICIPANT INTERNATIONAL DIAL IN:         1-412-317-5716
Please ask to be joined into the Beam Global call.

A webcast archive is available for 3 months following the call at the following URL:
https://services.choruscall.com/mediaframe/webcast.html?webcastid=dmWfd6VU

About Beam Global

Beam Global is a Cleantech leader that produces innovative, sustainable technology for electric vehicle (EV) charging, outdoor media, and energy security, without the construction, disruption, risks and costs of grid-tied solutions. Products include the patented EV ARC™ and Solar Tree® lines with BeamTrak™ patented solar tracking, and ARC Technology™ energy storage, along with EV charging, outdoor media and disaster preparedness packages.

The company develops, patents, designs, engineers and manufactures unique and advanced renewably energized products that save customers time and money, help the environment, empower communities and keep people moving. Based in San Diego, the company produces Made in America products. Beam Global is listed on Nasdaq under the symbols BEEM and BEEMW (formerly Envision Solar, EVSI, EVSIW). For more information visit https://BeamForAll.com/LinkedInYouTube and Twitter.

Forward-Looking Statements 

This Beam Global Press Release may contain forward-looking statements. All statements in this Press Release other than statements of historical facts are forward-looking statements.
Forward-looking statements are generally accompanied by terms or phrases such as “estimate,” “project,” “predict,” “believe,” “expect,” “anticipate,” “target,” “plan,” “intend,” “seek,” “goal,” “will,” “should,” “may,” or other words and similar expressions that convey the uncertainty of future events or results.  

Media Contact:

Next PR
[email protected]
+1 813-526-1195

Investor Relations:

Kathy McDermott
[email protected]
+1 858-295-7661

Beam Global  
Condensed Balance Sheets  
(000’s omitted)  
           
           
    March 31,   December 31,  
    2021   2020  
    (Unaudited)      
ASSETS        
Current assets          
Cash   $ 28,214   $ 26,703  
Accounts receivable   1,584   1,786  
Prepaid and other current assets   141   321  
Inventory, net   1,553   1,093  
Total current assets   31,492   29,903  
           
Property and equipment, net   250   235  
Operating lease right of use asset   2,362   2,419  
Patents, net   308   294  
Deposits   52   52  
Total assets   $ 34,464   $ 32,903  
           
LIABILITIES AND STOCKHOLDERS’ EQUITY          
Current liabilities          
Accounts payable   $ 895   $ 728  
Accrued expenses   531   392  
Sales tax payable   41   92  
Deferred revenue   98   107  
Operating lease liabilities, current   420   521  
Total current liabilities   1,985   1,840  
           
Operating lease liabilities, noncurrent   1,964   1,911  
Total liabilities   3,949   3,751  
           
Total stockholders’ equity   30,515   29,152  
Total liabilities and stockholders’ equity   $ 34,464   $ 32,903  
           

Beam Global  
Condensed Statements of Operations  
(000’s omitted except share and per share amounts)  
(Unaudited)  
                     
                     
              For the Three Months Ended March 31,  
              2021   2020  
                     
Revenues           $ 1,372   $ 1,317  
Cost of revenues         1,521   1,357  
Gross loss           (149)   (40)  
                     
Operating expenses         1,103   902  
Loss from operations         (1,252)   (942)  
                     
Other income (expense)              
     Interest income         1   9  
     Interest expense           (10)  
Total other income (expense), net       1   (1)  
                     
Net loss           $ (1,251)   $ (943)  
                     
Net loss per share – basic and diluted     $ (0.14)   $ (0.17)  
Weighted average shares outstanding – basic and diluted             8,764,959   5,523,174  
                     

 



Brookfield Infrastructure Completes Offering of $250 Million of 60-Year Subordinated Notes

All amounts in U.S. dollars

BROOKFIELD, News, May 24, 2021 (GLOBE NEWSWIRE) — Brookfield Infrastructure Partners L.P. (TSX: BIP.UN; NYSE: BIP) (“Brookfield Infrastructure”) today announced the closing of a public offering of $250 million of fixed rate subordinated notes due May 24, 2081 (the “notes”).     

The notes, which have a coupon of 5.00%, will be listed on the New York Stock Exchange under the symbol “BIPH”. Brookfield Infrastructure intends to use the net proceeds of the offering for the redemption of its Class A Preferred Units, Series 5, which are redeemable by Brookfield Infrastructure on September 30, 2021, with the remainder to be used for general corporate purposes.

The notes were issued by Brookfield Infrastructure Finance ULC, an indirect wholly-owned subsidiary of Brookfield Infrastructure, and are guaranteed on a subordinated basis by Brookfield Infrastructure and certain of its other subsidiaries.

BofA Securities, Inc., Citigroup Global Markets Inc., Morgan Stanley & Co. LLC, RBC Capital Markets, LLC and Wells Fargo Securities, LLC acted as joint book-running managers for the offering.

This news release does not constitute an offer to sell or the solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

The securities were not offered or sold, directly or indirectly, in Canada or to any resident of Canada.

Brookfield Infrastructure is a leading global infrastructure company that owns and operates high-quality, long-life assets in the utilities, transport, midstream and data sectors across North and South America, Asia Pacific and Europe. We are focused on assets that have contracted and regulated revenues that generate predictable and stable cash flows. Investors can access its portfolio either through Brookfield Infrastructure Partners L.P. (NYSE: BIP; TSX: BIP.UN), a Bermuda-based limited partnership, or Brookfield Infrastructure Corporation (NYSE, TSX: BIPC), a Canadian corporation. Further information is available at www.brookfield.com/infrastructure.

Brookfield Infrastructure is the flagship listed infrastructure company of Brookfield Asset Management, a global alternative asset manager with over $600 billion of assets under management. For more information, go to www.brookfield.com.

Contact information:  
Media: Investors:
Claire Holland Kate White
Senior Vice President – Communications Manager, Investor Relations
(416) 369-8236 (416) 956-5183

[email protected]

[email protected]


Cautionary Statement Regarding Forward-looking Statements

Note: This news release may contain forward-looking statements and information within the meaning of applicable securities laws. The words “will” and “intends”, derivatives thereof and other expressions which are predictions of or indicate future events, trends or prospects and which do not relate to historical matters, identify forward-looking statements. Forward-looking statements in this news release include statements regarding the offering and the use of proceeds therefrom, including the redemption of Brookfield Infrastructure’s Class A Preferred Units, Series 5. Although Brookfield Infrastructure believes that these forward-looking statements and information are based upon reasonable assumptions and expectations, the reader should not place undue reliance on them, or any other forward-looking statements or information in this news release. The future performance and prospects of Brookfield Infrastructure are subject to a number of known and unknown risks and uncertainties. Factors that could cause actual results of Brookfield Infrastructure to differ materially from those contemplated or implied by the statements in this news release are described in the documents filed by Brookfield Infrastructure with the securities regulators in Canada and the United States including under “Risk Factors” in Brookfield Infrastructure’s most recent Annual Report on Form 20-F and other risks and factors that are described therein. Except as required by law, Brookfield Infrastructure undertakes no obligation to publicly update or revise any forward-looking statements or information, whether as a result of new information, future events or otherwise.