Precision BioSciences Provides Updates on Azer-Cel FDA Meeting, Potential Partnerships and Timing of In Vivo R&D Day

Precision BioSciences Provides Updates on Azer-Cel FDA Meeting, Potential Partnerships and Timing of In Vivo R&D Day

DURHAM, N.C.–(BUSINESS WIRE)–
Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company developing ARCUS®-based in vivo gene editing and ex vivo allogeneic CAR T therapies, today announced that it has received final meeting minutes from its recent Type B End of Phase 1 meeting with the U.S. Food and Drug Administration (FDA) for its lead investigational allogeneic CAR T therapy azercabtagene zapreleucel (azer-cel).

“The objective of our meeting with the FDA was to gain further clarity on the potential registration path for azer‑cel including study design, endpoints and the recommended phase 2 dose for the CAR T relapsed patient setting – a patient population with dire need for better therapeutic options,” said Alan List, MD, Chief Medical Officer at Precision BioSciences. “We were able to accomplish the meeting objective and are appreciative of the FDA’s clear and thoughtful advice.”

The meeting with the FDA provided clarity and direction on azer-cel development, including a potential pathway toward registration. Based on the advice received from the FDA and clinical data shared during the May 2023 CAR T update, Precision is currently advancing discussions with multiple potential strategic partners for its cell therapy assets, including hematologic and non-hematologic applications.

“The ongoing collaborative discussions are intended to help us meet two key objectives: securing the right partner to build on our clinical-stage CAR T assets and allowing us to focus on core capabilities of in vivo gene editing,” said Michael Amoroso, Chief Executive Officer at Precision BioSciences. “We look forward to providing additional updates on our cell therapy strategic partnering initiatives as they develop.”

In Vivo R&D Day to be Held on September 12, 2023

Precision will host its in vivo gene editing R&D Day on September 12, 2023. This presentation will be focused on providing an update on ARCUS in vivo gene editing candidates and the broad potential and versatility of the platform. Additionally, this timing will allow strategic partnering discussions around the ex vivo allogeneic cell therapies to mature and enable full investor attention on our in vivo gene editing pipeline.

About Precision BioSciences, Inc.

Precision BioSciences, Inc. is a clinical stage biotechnology company dedicated to improving life (DTIL) with its novel and proprietary ARCUS® genome editing platform. ARCUS is a highly precise and versatile genome editing platform that was designed with therapeutic safety, delivery, and control in mind. Using ARCUS, the Company’s pipeline consists of several in vivo gene editing candidates designed to cure genetic and infectious diseases where no adequate treatments exist and multiple ex vivo clinical candidates. For more information about Precision BioSciences, please visit www.precisionbiosciences.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the clinical development, expected efficacy, and benefit of our product candidates, including our ability to progress azer-cel and other product candidates towards potential registration, the expected timing of updates regarding our allogeneic CAR T and in vivo programs, expectations about our operational initiatives and business strategy, expectations around partnership opportunities, and the timing of our in vivo gene editing R&D Day. In some cases, you can identify forward-looking statements by terms such as “aim,” “anticipate,” “approach,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “goal,” “intend,” “look,” “may,” “mission,” “plan,” “possible,” “potential,” “predict,” “project,” “pursue,” “should,” “target,” “will,” “would,” or the negative thereof and similar words and expressions.

Forward-looking statements are based on management’s current expectations, beliefs and assumptions and on information currently available to us. These statements are neither promises nor guarantees, but involve number of known and unknown risks, uncertainties and assumptions, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various important factors, including, but not limited to: our ability to become profitable; our ability to procure sufficient funding and requirements under our current debt instruments and effects of restrictions thereunder; risks associated with raising additional capital; our operating expenses and our ability to predict what those expenses will be; our limited operating history; the success of our programs and product candidates in which we expend our resources; our limited ability or inability to assess the safety and efficacy of our product candidates; the risk that other genome-editing technologies may provide significant advantages over our ARCUS technology; our dependence on our ARCUS technology; the initiation, cost, timing, progress, achievement of milestones and results of research and development activities and preclinical and clinical studies; public perception about genome editing technology and its applications; competition in the genome editing, biopharmaceutical, and biotechnology fields; our or our collaborators’ ability to identify, develop and commercialize product candidates; pending and potential product liability lawsuits and penalties against us or our collaborators related to our technology and our product candidates; the U.S. and foreign regulatory landscape applicable to our and our collaborators’ development of product candidates; our or our collaborators’ ability to advance product candidates into, and successfully design, implement and complete, clinical or field trials; potential manufacturing problems associated with the development or commercialization of any of our product candidates; our ability to obtain an adequate supply of T cells from qualified donors; our ability to achieve our anticipated operating efficiencies at our manufacturing facility; delays or difficulties in our and our collaborators’ ability to enroll patients; changes in interim “top-line” and initial data that we announce or publish; if our product candidates do not work as intended or cause undesirable side effects; risks associated with applicable healthcare, data protection, privacy and security regulations and our compliance therewith; our ability to obtain orphan drug designation or fast track designation for our product candidates or to realize the expected benefits of these designations; our or our collaborators’ ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions, limitations and/or warnings in the label of an approved product candidate; the rate and degree of market acceptance of any of our product candidates; our ability to effectively manage the growth of our operations; our ability to attract, retain, and motivate executives and personnel; effects of system failures and security breaches; insurance expenses and exposure to uninsured liabilities; effects of tax rules; effects of the COVID-19 pandemic and variants thereof, or any pandemic, epidemic, or outbreak of an infectious disease; the success of our existing collaboration agreements, and our ability to enter into new collaboration arrangements; our current and future relationships with and reliance on third parties including suppliers and manufacturers; our ability to obtain and maintain intellectual property protection for our technology and any of our product candidates; potential litigation relating to infringement or misappropriation of intellectual property rights; effects of natural and manmade disasters, public health emergencies and other natural catastrophic events; effects of sustained inflation, supply chain disruptions and major central bank policy actions; market and economic conditions; risks related to ownership of our common stock, including fluctuations in our stock price, and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2023, as any such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov and the Investors page of our website under SEC Filings at investor.precisionbiosciences.com.

All forward-looking statements speak only as of the date of this press release and, except as required by applicable law, we have no obligation to update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Investor and Media Contact:

Mei Burris

Director, Investor Relations and Finance

[email protected]

KEYWORDS: United States North America North Carolina

INDUSTRY KEYWORDS: Research FDA Genetics Clinical Trials Biotechnology General Health Pharmaceutical Health Science Oncology

MEDIA:

Logo
Logo

Intellia Therapeutics to Hold Conference Call to Discuss Second Quarter 2023 Earnings and Company Updates

CAMBRIDGE, Mass., July 27, 2023 (GLOBE NEWSWIRE) — Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage genome editing company focused on developing potentially curative therapeutics leveraging CRISPR-based technologies, will present its second quarter 2023 financial results and operational highlights in a conference call on August 3, 2023, at 8 a.m. ET.

To join the call:

  • U.S. callers should dial 1-833-316-0545 and international callers should dial 1-412-317-5726, approximately five minutes before the call. All participants should ask to be connected to the Intellia Therapeutics conference call.
  • Please visit this link for a simultaneous live webcast of the call.

A replay of the call will be available through the Events and Presentations page of the Investors & Media section on Intellia’s website at www.intelliatx.com, beginning on August 3, 2023, at 12 p.m. ET.

About Intellia Therapeutics

Intellia Therapeutics, a leading clinical-stage genome editing company, is developing novel, potentially curative therapeutics leveraging CRISPR-based technologies. To fully realize the transformative potential of CRISPR-based technologies, Intellia is pursuing two primary approaches. The company’s in vivo programs use intravenously administered CRISPR as the therapy, in which proprietary delivery technology enables highly precise editing of disease-causing genes directly within specific target tissues. Intellia’s ex vivo programs use CRISPR to create the therapy by using engineered human cells to treat cancer and autoimmune diseases. Intellia’s deep scientific, technical and clinical development experience, along with its robust intellectual property portfolio, have enabled the company to take a leadership role in harnessing the full potential of genome editing to create new classes of genetic medicine. Learn more at intelliatx.com. Follow us on Twitter @intelliatx.


Intellia Contacts:

Investors:

Ian Karp
Senior Vice President, Investor Relations and Corporate Communications
+1-857-449-4175
[email protected]

Lina Li
Senior Director, Investor Relations and Corporate Communications
+1-857-706-1612
[email protected]



Cybin to Participate in the Canaccord Genuity 43rd Annual Growth Conference

Cybin to Participate in the Canaccord Genuity 43rd Annual Growth Conference

TORONTO–(BUSINESS WIRE)–Cybin Inc. (NYSE American:CYBN) (NEO:CYBN) (“Cybin” or the “Company”), a clinical-stage biopharmaceutical company committed to revolutionizing mental healthcare by developing new and innovative psychedelic-based treatment options, is pleased to announce that Doug Drysdale, Cybin’s Chief Executive Officer, will participate in a fireside chat at the Canaccord Genuity 43rd Annual Growth Conference, taking place August 7-10, 2023 in Boston, MA.

Mr. Drysdale’s fireside chat will be webcast live on Thursday, August 10, 2023 at 11:00 a.m. ET. To listen to the event, please click here to access the webcast. The archived webcast will also be available on the Company’s investor relations website on the Events & Presentations page.

About Cybin

Cybin is a clinical-stage biopharmaceutical company on a mission to create safe and effective psychedelic-based therapeutics to address the large unmet need for new and innovative treatment options for people who suffer from mental health conditions.

Cybin’s goal of revolutionizing mental healthcare is supported by a network of world-class partners and internationally recognized scientists aimed at progressing proprietary drug discovery platforms, innovative drug delivery systems, and novel formulation approaches and treatment regimens. The Company is currently developing CYB003, a proprietary deuterated psilocybin analog for the treatment of major depressive disorder and CYB004, a proprietary deuterated DMT molecule for generalized anxiety disorder and has a research pipeline of investigational psychedelic-based compounds.

Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. For company updates and to learn more about Cybin, visit www.cybin.com or follow the team on Twitter, LinkedIn, YouTube and Instagram.

Investor & Media:

Gabriel Fahel

Chief Legal Officer

Cybin Inc.

1-866-292-4601

[email protected] – or – [email protected]

KEYWORDS: Massachusetts United States North America Canada

INDUSTRY KEYWORDS: Alternative Medicine Mental Health Health Clinical Trials Pharmaceutical Biotechnology

MEDIA:

Logo
Logo

Titan Pharmaceuticals Announces Sale of Certain ProNeura Assets

Company to receive $2 million in upfront payments, with the potential to receive up to $50 million in milestone payments and single digit royalty payments on future net sales

SAN FRANCISCO, July 27, 2023 (GLOBE NEWSWIRE) — Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) (“Titan” or the “Company”) today announced that it has entered into an Asset Purchase Agreement (the “Agreement”) with Fedson, Inc., a Delaware Corporation (“Fedson”), for the sale of certain ProNeura assets including Titan’s portfolio of drug addiction products, in addition to other early development programs based on the ProNeura drug delivery technology. The Company’s addiction portfolio consists of the Probuphine and Nalmefene implant programs. 

Under the terms of the Agreement, Fedson will purchase the ProNeura assets from Titan for an upfront purchase price of $2 million ($1 million at closing, $1 million to be held in escrow pending completion of certain conditions) with potential milestone payments to Titan of up to $50 million on future net sales of the products. Titan would also receive single digit royalties on future net sales of the products. Additionally, Fedson will assume all liabilities related to a pending employment claim against Titan. The transaction is expected to close 10 days following signing of the Agreement.

“This transaction provides the opportunity for two much-needed products for the treatment of Opioid Use Disorder to continue, with the potential return of Probuphine as an available treatment option and the possible continuation of the development of the Nalmefene product, and allows Titan to renew our focus on extracting value from our principal asset, TP-2021 for the treatment of pruritus,” commented Kate Beebe DeVarney, Ph.D., President and Chief Operating Officer of Titan Pharmaceuticals.

“We are pleased to announce the sale of these potentially lifesaving assets to Fedson,” stated David E. Lazar, Chief Executive Officer of Titan Pharmaceuticals. “The injection of this upfront non-dilutive capital, with the potential for future milestone and royalty payments not only strengthens our current balance sheet but provides future upside potential. This transaction is in line with our focus to evaluate all options to enhance shareholder value.”    

About Titan Pharmaceuticals

Titan Pharmaceuticals, Inc. (NASDAQ: TTNP), based in South San Francisco, CA, is a development stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology. The ProNeura technology has the potential to be used in developing products for treating a number of chronic conditions, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. In December 2021, Titan commenced a process to explore and evaluate strategic alternatives to enhance shareholder value.

Forward-Looking Statements

This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management’s current expectations include those risks and uncertainties relating to our ability to raise capital, the regulatory approval process, the development, testing, production and marketing of our drug candidates, patent and intellectual property matters and strategic agreements and relationships. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law. A complete discussion of the risks and uncertainties that may affect Schmitt’s business, including the business of its subsidiary, is included in “Risk Factors” in the Company’s most recent Annual Report on Form 10-K as filed by the Company with the Securities and Exchange Commission.


Media & Investor Contacts:

Kate Beebe DeVarney, Ph.D.

President and Chief Operating Officer
(650) 989-2268



Camping World Acquires the Assets of Breeden RV, Opens Its 200th RV Dealership

Camping World Acquires the Assets of Breeden RV, Opens Its 200th RV Dealership

LINCOLNSHIRE, Ill.–(BUSINESS WIRE)–
Camping World Holdings, Inc. (NYSE: CWH) (“Camping World”), the World’s Largest Recreational Vehicle Dealer, today announced the opening of 200th RV dealership in Van Buren, Arkansas, coinciding with the closing of its previously announced Breeden RV acquisition.

Camping World Chairman and CEO Marcus Lemonis commented, “The opening of our 200th RV dealership is a testament to the hard work and dedication of our over 14,000 employees and their passion for the customers they serve. It’s our goal to increase our store count by 50% over the next five years, through a combination of acquisitions, new store openings, and manufacturer exclusive locations.”

The Van Buren, Arkansas dealership is located at 5603 Alma Hwy, Van Buren, AR 72956. The SuperCenter offers a wide range of new and used RVs from top manufacturers in addition to a full assortment of RV and outdoor products and accessories and the entire portfolio of Good Sam products and services.

Individuals interested in applying for a position may visit http://www.campingworldjobs.com/.

About Camping World Holdings, Inc.

Camping World Holdings, Inc., headquartered in Lincolnshire, IL, (together with its subsidiaries) is the World’s largest retailer of RVs and related products and services. Our vision is to build a long-term legacy business that makes RVing fun and easy. Our Camping World and Good Sam brands have been serving RV consumers since 1966. We strive to build long-term value for our customers, employees, and shareholders by combining a unique and comprehensive assortment of RV products and services with a national network of RV dealerships, service centers and customer support centers along with the industry’s most extensive online presence and a highly trained and knowledgeable team of employees serving our customers, the RV lifestyle, and the communities in which we operate. We also believe that our Good Sam organization and family of programs and services uniquely enable us to connect with our customers as stewards of the RV enthusiast community and the RV lifestyle. With RV sales and service locations in 43 states, Camping World has grown to become the prime destination for everything RV. For more information, visit www.CampingWorld.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 concerning Camping World and other matters. All statements other than statements of historical facts contained in this press release may be forward-looking statements, including statements about our future goals, plans and objectives of management, anticipated store growth, the expected benefits from acquisitions and new stores, and offerings of future locations. In some cases, you can identify forward-looking statements by terms such as ‘‘may,’’ ‘‘will,’’ ‘‘should,’’ ‘‘expects,’’ ‘‘plans,’’ ‘‘anticipates,’’ ‘‘could,’’ ‘‘intends,’’ ‘‘targets,’’ ‘‘projects,’’ ‘‘contemplates,’’ ‘‘believes,’’ ‘‘estimates,’’ ‘‘predicts,’’ ‘‘potential’’ or ‘‘continue’’ or the negative of these terms or other similar expressions. The forward-looking statements in this press release are only predictions. 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 business, financial condition, and results of operations. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. You should carefully consider the risks and uncertainties that affect our business, including the risk that store growth may not occur on the timelines expected or at all, as well as the other important risks described in our filings with the Securities and Exchange Commission (“SEC”), including under the caption “Risk Factors” in our Annual Report on Form 10-K filed for the year ended December 31, 2022. These forward-looking statements speak only as of the date of this communication. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements, whether as a result of any new information, future events or otherwise. You are advised, however, to consult any further disclosures we make on related subjects in our public announcements and filings with the SEC.

Brett Andress

[email protected]

Media Outlets:

[email protected]

KEYWORDS: United States North America Illinois

INDUSTRY KEYWORDS: Retail Alternative Vehicles/Fuels Other Travel Transportation Other Automotive EV/Electric Vehicles Recreational Vehicles Travel Fleet Management General Automotive Specialty Family Vacation Automotive Consumer

MEDIA:

Logo
Logo

Thryv Ranks in Top Ten on Selling Power’s Annual 50 Best Companies to Sell for List

Thryv Ranks in Top Ten on Selling Power’s Annual 50 Best Companies to Sell for List

DALLAS–(BUSINESS WIRE)–Thryv Holdings, Inc. (NASDAQ:THRY) (“Thryv” or the “Company”), the provider of the leading small and medium sized business (“SMB”) software platform, announced today that it has been ranked #8 on Selling Power’s 50 Best Companies to Sell For 2023 list. Thryv’s appearance on the list is its sixth in as many years. Since its debut on the list in 2018, Thryv has continued to improve its ranking annually.

“Our Local Business Advisors partner every day with SMBs to help them adopt, embrace and leverage our software platform,” said Thryv Chief Revenue Officer Jim McCusker. “We know we can provide the service to make that happen. In the end, both the SMBs and Thryv win.”

Selling Power’s 50 Best list is chosen based on four main categories:

  • Compensation and benefits

  • Sales culture

  • Onboarding and sales enablement strategies

  • Sales training and coaching

“As companies are facing economic headwinds, sales organizations are sharpening their focus on sales talent. What attracts salespeople to work for these leading organizations is their great culture, their commitment to diversity, and their steady support of the sales team by servant leadership that focuses on creating customer value and a meaningful work environment that offers unlimited opportunities to win,” says Gerhard Gschwandtner, founder and CEO of Selling Power. “These companies aim at a higher level of professionalism and trust, which in turn leads to increased sales and a lower turnover of the sales force,” Gschwandtner continued.

Companies were ranked in each of the four above categories to determine the final list. The methodology is the product of years of research, and Selling Power continues to revise and refine the approach each year. The companies included are a mix of sizes ranging from medium to enterprise.

You can view the full list of the 50 Best Companies to Sell For in 2023 here.

About Thryv Holdings, Inc.

Thryv Holdings, Inc. (NASDAQ: THRY) is a global leader in small business management software. More than 50,000 small- to medium-sized businesses (SMBs) utilize our award-winning SaaS platform, Thryv®, to grow and modernize their operations, empowering them to win in today’s economy. Thryv also manages the digital and print presence of over 400,000 SMBs, connecting them to local consumers via proprietary local online and print directories and popular social media and search engines, helping them gain new customers and grow their bottom line. For more information about Thryv Holdings, Inc, visit thryv.com.

Media Contact:

Paige Blankenship

Thryv, Inc.

214.392.9609

[email protected]

Investor Contact:

Cameron Lessard

Thryv, Inc.

214.773.7022

[email protected]

KEYWORDS: United States North America Texas

INDUSTRY KEYWORDS: Software Marketing Consulting Data Management Communications Small Business Professional Services Technology

MEDIA:

Logo
Logo

NETSCOUT Reports First Quarter Fiscal Year 2024 Financial Results

NETSCOUT Reports First Quarter Fiscal Year 2024 Financial Results

Delivered Solid Q1 Financial Performance

Released Next-Generation Technologies to Support 2H FY2024 Revenue Ramp

WESTFORD, Mass.–(BUSINESS WIRE)–NETSCOUT SYSTEMS, INC. (NASDAQ: NTCT), a leading provider of enterprise performance management, carrier service assurance, cybersecurity, and DDoS protection, today announced financial results for its first quarter ended June 30, 2023.

Remarks by Anil Singhal, NETSCOUT’s President and Chief Executive Officer:

“We delivered a solid financial performance in the first quarter of our fiscal year with total revenue in-line with our expectations and double-digit percentage improvement in diluted earnings per share year over year. At the same time, we released several new product offerings, including our ‘Visibility Without Borders’ platform, our next-generation Omnis Cyber Intelligence solution, Adaptive DDoS, and Mobile Security, all of which we expect to begin contributing to revenue in the second half of the current fiscal year. Looking ahead, we are reiterating our fiscal year 2024 outlook and remain focused on delivering long-term stakeholder value.”

Q1 FY24 Financial Results

Total revenue (GAAP and non-GAAP) for the first quarter of fiscal year 2024 was $211.1 million, compared with $208.8 million (GAAP and non-GAAP) in the first quarter of fiscal year 2023. A reconciliation of all GAAP and non-GAAP results are included in the financial tables below.

Product revenue (GAAP and non-GAAP) for the first quarter of fiscal year 2024 was $94.7 million, or approximately 45% of total revenue in the period. This compares with product revenue (GAAP and non-GAAP) of $98.3 million in the first quarter of fiscal year 2023, which was approximately 47% of total revenue in the period. As of June 30, 2023, NETSCOUT had a product backlog consisting of fulfillable orders of approximately $12 million, which excludes radio frequency propagation modeling orders of approximately $4 million. This compares with approximately $39 million of fulfillable orders and $45 million of radio frequency propagation modeling orders as of June 30, 2022.

Service revenue (GAAP and non-GAAP) for the first quarter of fiscal year 2024 was $116.5 million, or approximately 55% of total revenue in the period. This compares with service revenue (GAAP and non-GAAP) of $110.6 million in the first quarter of fiscal year 2023, which was approximately 53% of total revenue for the period.

NETSCOUT’s loss from operations (GAAP) was $4.7 million in the first quarter of fiscal year 2024, compared with a loss from operations (GAAP) of $9.1 million in the first quarter of fiscal year 2023. The Company’s operating margin (GAAP) was negative 2.2% in the first quarter of fiscal year 2024, versus negative 4.4% in the same period of fiscal year 2023. Non-GAAP income from operations was $29.6 million with a non-GAAP operating margin of 14.0% in the first quarter of fiscal year 2024. This compares to non-GAAP income from operations of $24.5 million and a non-GAAP operating margin of 11.7% in the first quarter of fiscal year 2023. Non-GAAP EBITDA from operations in the first quarter of fiscal year 2024 was $34.6 million, or 16.4% of non-GAAP quarterly revenue for the period. This compares to non-GAAP EBITDA from operations of $29.8 million in the first quarter of fiscal year 2023, or 14.3% of non-GAAP quarterly revenue for the period.

Net loss (GAAP) for the first quarter of fiscal year 2024 was $4.2 million, or a net loss of $0.06 per share (diluted), versus a net loss of $7.1 million, or a net loss of $0.10 per share (diluted), for the first quarter of fiscal year 2023. On a non-GAAP basis, net income for the first quarter of fiscal year 2024 was $22.7 million, or $0.31 per share (diluted), compared with $18.1 million, or $0.24 per share (diluted), for the first quarter of fiscal year 2023.

As of June 30, 2023, cash, cash equivalents, short-term and long-term marketable securities, and investments, were $390.5 million, compared with $427.9 million as of March 31, 2023, and $374.6 million as of June 30, 2022. The Company’s outstanding debt balance under its revolving credit facility was $100 million as of June 30, 2023. The $800 million revolving credit facility will expire in July 2026.

Financial Outlook

NETSCOUT is reiterating its revenue and diluted net income per share outlook (GAAP and non-GAAP) for fiscal year 2024, all of which were previously issued by the Company on May 4, 2023, in its fourth quarter and full fiscal year 2023 earnings press release. The Company’s financial outlook for fiscal year 2024 remains as follows:

  • Revenue (GAAP and non-GAAP) in the range of $915 million to $945 million.

  • GAAP net income per share (diluted) in the range of $0.86 to $0.98. Non-GAAP net income per share (diluted) in the range of $2.20 to $2.32.

A reconciliation between GAAP and non-GAAP numbers for NETSCOUT’s fiscal year 2024 outlook is included in the financial tables below.

Recent Developments and Highlights

  • In late July 2023, NETSCOUT announced its next-generation Omnis Cyber Intelligence (OCI) solution, an advanced network detection and response (NDR) solution. OCI uses highly scalable deep packet inspection (DPI) and multiple threat detection methods at the source of packet capture to detect threats in real time and via historical investigation of high-fidelity network metadata and packets. OCI helps identify threats earlier in the attack life cycle and quickens investigations by gathering network-based forensic evidence to reduce the Mean Time to Response (MTTR). OCI is also a valuable tool for verifying the effectiveness and improving the existing cybersecurity ecosystem, ensuring compliance, and lowering the risk of successful cyberattacks.

  • In mid-July 2023, NETSCOUT released its latest version of Arbor Edge Defense (AED) which includes new ML-based Adaptive DDoS Protection. This solution combines leading global threat intelligence with machine learning to protect enterprises from rapidly spreading dynamic DDoS attacks.

  • In June 2023, NETSCOUT introduced its Visibility Without Borders® (VWB) platform to help essential organizations keep goods and services flowing by uniting performance, security, and availability under one common data framework. By proactively identifying areas of complexity, fragility, and risk, the platform unlocks insights at unparalleled scale to deliver the intelligence needed to increase visibility, improve agility, and keep data and applications secure.

  • In May 2023, NETSCOUT introduced Mobile Security using Arbor® Sightline Mobile and MobileStream to answer mobile network operators’ (MNO) need for scalable, real-time visibility, detection, and mitigation of threats that can impact the performance and availability of 4G/5G mobile consumer services and network infrastructure.

Conference Call Instructions:

NETSCOUT will host a conference call to discuss its first quarter fiscal year 2024 financial results and financial outlook today at 8:30 a.m. ET. This call will be webcast live through NETSCOUT’s website at https://ir.netscout.com/investors/overview/default.aspx. Alternatively, investors can listen to the call by dialing (203) 518-9708. The conference call ID is NTCTQ124. A replay of the call will be available after 12:00 p.m. ET today, for approximately one week. The number for the replay is (800) 839-2417 for U.S./Canada callers and (402) 220-7209 for international callers.

Use of Non-GAAP Financial Information:

To supplement the financial measures presented in NETSCOUT’s press release in accordance with accounting principles generally accepted in the United States (GAAP), NETSCOUT also reports the following non-GAAP measures: non-GAAP gross profit, non-GAAP income from operations, non-GAAP net income, non-GAAP diluted net income per share and non-GAAP earnings before interest and other expense, income taxes, depreciation, and amortization (EBITDA) from operations. Non-GAAP gross profit removes expenses related to the amortization of acquired intangible assets, share based compensation, and acquisition-related depreciation. Non-GAAP income from operations includes the aforementioned adjustments and also removes restructuring charges and legal expenses related to civil judgements. Non-GAAP net income includes the foregoing adjustments related to non-GAAP income from operations, and also removes change in fair value of derivative instrument, net of related income tax effects. Non-GAAP diluted net income per share includes the foregoing adjustments related to non-GAAP net income. Non-GAAP EBITDA from operations includes the aforementioned items related to non-GAAP income from operations and also removes non-acquisition related depreciation expense. Investors are encouraged to review the related GAAP financial measures and the reconciliation of these non-GAAP financial measures to their most directly comparable GAAP financial measures included in the attached tables within this press release.

These non-GAAP measures are not in accordance with GAAP, should not be considered an alternative for measures prepared in accordance with GAAP (gross profit, operating margin, net income, and diluted net income per share), and may have limitations because they do not reflect all of NETSCOUT’s results of operations as determined in accordance with GAAP. These non-GAAP measures should only be used to evaluate NETSCOUT’s results of operations in conjunction with the corresponding GAAP measures. The presentation of non-GAAP information is not meant to be considered superior to, in isolation from, or as a substitute for results prepared in accordance with GAAP. NETSCOUT believes these non-GAAP financial measures will enhance the reader’s overall understanding of NETSCOUT’s current financial performance and NETSCOUT’s prospects for the future by providing a higher degree of transparency for certain financial measures and providing a level of disclosure that helps investors understand how the Company plans and measures its own business. NETSCOUT believes that providing these non-GAAP measures affords investors a view of NETSCOUT’s operating results that may be more easily compared to peer companies and also enables investors to consider NETSCOUT’s operating results on both a GAAP and non-GAAP basis during and following the integration period of NETSCOUT’s acquisitions. Presenting the GAAP measures on their own, without the supplemental non-GAAP disclosures, might not be indicative of NETSCOUT’s core operating results. Furthermore, NETSCOUT believes that the presentation of non-GAAP measures when shown in conjunction with the corresponding GAAP measures provides useful information to management and investors regarding present and future business trends relating to its financial condition and results of operations.

NETSCOUT management regularly uses supplemental non-GAAP financial measures internally to understand, manage and evaluate its business and to make operating decisions. These non-GAAP measures are among the primary factors that management uses in planning and forecasting.

About NETSCOUT SYSTEMS, INC.

NETSCOUT SYSTEMS, INC. (NASDAQ: NTCT) protects the connected world from cyberattacks and performance and availability disruptions through the company’s unique visibility platform and solutions powered by its pioneering deep packet inspection at scale technology. NETSCOUT serves the world’s largest enterprises, service providers, and public sector organizations. Learn more at www.netscout.com or follow @NETSCOUT on LinkedIn, Twitter, or Facebook.

Safe Harbor

Certain information provided in this press release includes forward-looking statements within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Examples of forward-looking statements include statements regarding our future financial performance or position, results of operations, business strategy, plans and objectives of management for future operations, and other statements that are not historical fact. You can identify forward-looking statements by their use of forward-looking words such as “may,” “will,” “anticipate,” “expect,” “believe,” “estimate,” “intend,” “plan,” “should,” “seek,” or other comparable terms. Investors are cautioned that such forward-looking statements in this press release including, without limitation, statements regarding NETSCOUT’s financial outlook for fiscal year 2024, that it expects that its new product releases to contribute to revenue in the second half of the current fiscal year, that it remains focused on delivering long-term stakeholder value, as well as statements relating to the potential benefit of a market for the Company’s products and regarding product releases, updates, and functionality all constitute forward looking statements that involve risks and uncertainties. Actual results could differ materially from the forward-looking statements due to known and unknown risks, uncertainties, assumptions, and other factors. Such factors include, but are not limited to, macroeconomic factors and slowdowns or downturns in economic conditions generally and in the market for advanced network, service assurance and cybersecurity solutions specifically; the volatile foreign exchange environment; liquidity concerns at, and failures of, banks and other financial institutions; the Company’s relationships with strategic partners and resellers; dependence upon broad-based acceptance of the Company’s network performance management solutions; the presence of competitors with greater financial resources than the Company has, and their strategic response to the Company’s products; the Company’s ability to retain key executives and employees; the Company’s ability to realize the anticipated savings from recent restructuring actions and other expense management programs; lower than expected demand for the Company’s products and services; the impacts of epidemics or pandemics such as COVID-19; and the timing and magnitude of stock buyback activity based on market conditions, corporate considerations, debt agreements, and regulatory requirements. The risks included above are not exhaustive. We caution readers not to place undue reliance on any forward-looking statements included in this press release which speak only as to the date of this press release. We undertake no responsibility to update or revise any forward-looking statements, except as required by law. For a more detailed description of the risk factors associated with the Company, please refer to the Company’s Annual Report on Form 10-K for the fiscal year ended March 31, 2023, filed with the Securities and Exchange Commission. NETSCOUT assumes no obligation to update any forward-looking information contained in this press release or with respect to the announcements described herein.

©2023 NETSCOUT SYSTEMS, INC. All rights reserved. NETSCOUT and the NETSCOUT logo are registered trademarks or trademarks of NETSCOUT SYSTEMS, INC. and/or its subsidiaries and/or affiliates in the USA and/or other countries.

NETSCOUT SYSTEMS, INC.
Condensed Consolidated Statements of Operations
(In thousands, except per share data)
(Unaudited)
 
Three Months Ended
June 30,

 

2023

 

 

2022

 

Revenue:
Product

$

94,661

 

$

98,251

 

Service

 

116,477

 

 

110,561

 

Total revenue

 

211,138

 

 

208,812

 

 
Cost of revenue:
Product

 

16,662

 

 

26,805

 

Service

 

33,734

 

 

30,909

 

Total cost of revenue

 

50,396

 

 

57,714

 

 
Gross profit

 

160,742

 

 

151,098

 

 
Operating expenses:
Research and development

 

45,520

 

 

43,457

 

Sales and marketing

 

78,996

 

 

76,323

 

General and administrative

 

28,214

 

 

24,790

 

Amortization of acquired intangible assets

 

12,707

 

 

13,881

 

Restructuring charges

 

 

 

1,774

 

 
Total operating expenses

 

165,437

 

 

160,225

 

 
Loss from operations

 

(4,695

)

 

(9,127

)

Interest and other expense, net

 

(639

)

 

(1,358

)

 
Loss before income tax benefit

 

(5,334

)

 

(10,485

)

Income tax benefit

 

(1,134

)

 

(3,353

)

Net loss

$

(4,200

)

$

(7,132

)

 
 
Basic net loss per share

$

(0.06

)

$

(0.10

)

Diluted net loss per share

$

(0.06

)

$

(0.10

)

Weighted average common shares outstanding used in computing:
Net loss per share – basic

 

71,540

 

 

72,452

 

Net loss per share – diluted

 

71,540

 

 

72,452

 

 
 
NETSCOUT SYSTEMS, INC.
Consolidated Balance Sheets
(In thousands)
(Unaudited)
 
June 30, March 31,

 

2023

 

 

2023

 

 
Assets
Current assets:
Cash, cash equivalents, marketable securities and investments

$

384,603

 

$

418,998

 

Accounts receivable and unbilled costs, net

 

108,292

 

 

143,855

 

Inventories and deferred costs

 

18,449

 

 

17,956

 

Prepaid expenses and other current assets

 

38,327

 

 

36,551

 

 
Total current assets

 

549,671

 

 

617,360

 

 
Fixed assets, net

 

33,207

 

 

34,735

 

Operating lease right-of-use assets

 

49,432

 

 

51,456

 

Goodwill and intangible assets, net

 

2,076,033

 

 

2,090,995

 

Long-term marketable securities

 

5,881

 

 

8,940

 

Other assets

 

16,373

 

 

17,074

 

 
Total assets

$

2,730,597

 

$

2,820,560

 

 
 
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable

$

14,400

 

$

16,473

 

Accrued compensation

 

53,627

 

 

83,279

 

Accrued other

 

20,659

 

 

30,674

 

Deferred revenue and customer deposits

 

282,773

 

 

311,531

 

Current portion of operating lease liabilities

 

11,727

 

 

11,650

 

 
Total current liabilities

 

383,186

 

 

453,607

 

 
Other long-term liabilities

 

7,534

 

 

7,683

 

Deferred tax liability

 

13,625

 

 

24,939

 

Accrued long-term retirement benefits

 

26,257

 

 

26,049

 

Long-term deferred revenue and customer deposits

 

122,381

 

 

129,814

 

Operating lease liabilities, net of current portion

 

46,404

 

 

48,819

 

Long-term debt

 

100,000

 

 

100,000

 

 
Total liabilities

 

699,387

 

 

790,911

 

 
Stockholders’ equity:
Common stock

 

130

 

 

128

 

Additional paid-in capital

 

3,118,798

 

 

3,099,698

 

Accumulated other comprehensive income

 

5,803

 

 

5,738

 

Treasury stock, at cost

 

(1,559,534

)

 

(1,546,128

)

Retained earnings

 

466,013

 

 

470,213

 

 
Total stockholders’ equity

 

2,031,210

 

 

2,029,649

 

 
Total liabilities and stockholders’ equity

$

2,730,597

 

$

2,820,560

 

 
NETSCOUT SYSTEMS, INC.
Reconciliation of Current GAAP to Current and Historical Non-GAAP Financial Measures
(In thousands, except per share data)
(Unaudited)
     
Three Months Ended   Three Months Ended
June 30,   March 31,

 

2023

 

 

 

2022

 

 

 

2023

 

     
GAAP and Non-GAAP Revenue

$

211,138

 

 

$

208,812

 

 

$

208,093

 

     
Gross Profit (GAAP)

$

160,742

 

 

$

151,098

 

 

$

157,152

 

Share-based compensation expense (1)

 

2,911

 

 

 

2,037

 

 

 

1,940

 

Amortization of acquired intangible assets (2)

 

1,638

 

 

 

2,328

 

 

 

2,329

 

Acquisition related depreciation expense (3)

 

5

 

 

 

7

 

 

 

6

 

Non-GAAP Gross Profit

$

165,296

 

 

$

155,470

 

 

$

161,427

 

     
Income (Loss) from Operations (GAAP)

$

(4,695

)

 

$

(9,127

)

 

$

1,638

 

GAAP Operating Margin

 

-2.2

%

 

 

-4.4

%

 

 

0.8

%

Share-based compensation expense (1)

 

19,844

 

 

 

15,581

 

 

 

14,761

 

Amortization of acquired intangible assets (2)

 

14,345

 

 

 

16,209

 

 

 

16,219

 

Restructuring charges

 

 

 

 

1,774

 

 

 

(21

)

Acquisition related depreciation expense (3)

 

59

 

 

 

65

 

 

 

58

 

Legal expenses related to civil judgments (4)

 

41

 

 

 

 

 

 

50

 

Non-GAAP Income from Operations

$

29,594

 

 

$

24,502

 

 

$

32,705

 

Non-GAAP Operating Margin

 

14.0

%

 

 

11.7

%

 

 

15.7

%

     
Net Loss (GAAP)

$

(4,200

)

 

$

(7,132

)

 

$

(3,221

)

Share-based compensation expense (1)

 

19,844

 

 

 

15,581

 

 

 

14,761

 

Amortization of acquired intangible assets (2)

 

14,345

 

 

 

16,209

 

 

 

16,219

 

Restructuring charges

 

 

 

 

1,774

 

 

 

(21

)

Acquisition related depreciation expense (3)

 

59

 

 

 

65

 

 

 

58

 

Legal expenses related to civil judgments (4)

 

41

 

 

 

 

 

 

50

 

Change in fair value of derivative instrument (5)

 

(206

)

 

 

 

 

 

1,380

 

Income tax adjustments (6)

 

(7,171

)

 

 

(8,445

)

 

 

(2,041

)

Non-GAAP Net Income

$

22,712

 

 

$

18,052

 

 

$

27,185

 

     
Diluted Net Loss Per Share (GAAP)

$

(0.06

)

 

$

(0.10

)

 

$

(0.05

)

Share impact of non-GAAP adjustments identified above

 

0.37

 

 

 

0.34

 

 

 

0.43

 

Non-GAAP Diluted Net Income Per Share

$

0.31

 

 

$

0.24

 

 

$

0.38

 

     
Shares used in computing non-GAAP diluted net income per share

 

72,995

 

 

 

74,187

 

 

 

72,491

 

NETSCOUT SYSTEMS, INC.
Reconciliation of Current GAAP to Current and Historical Non-GAAP Financial Measures – Continued
(In thousands)
(Unaudited)
     
Three Months Ended   Three Months Ended
June 30,   March 31,

 

2023

 

 

 

2022

 

 

 

2023

 

     

(1)

Share-based compensation expense included in these amounts    
is as follows:    
Cost of product revenue

$

372

 

 

$

292

 

 

$

260

 

Cost of service revenue

 

2,539

 

 

 

1,745

 

 

 

1,680

 

Research and development

 

5,386

 

 

 

4,431

 

 

 

3,870

 

Sales and marketing

 

7,284

 

 

 

5,750

 

 

 

5,374

 

General and administrative

 

4,263

 

 

 

3,363

 

 

 

3,577

 

Total share-based compensation expense

$

19,844

 

 

$

15,581

 

 

$

14,761

 

     

(2)

Amortization expense related to acquired software and product    
technology, tradenames, customer relationships included in these    
amounts is as follows:    
Cost of product revenue

$

1,638

 

 

$

2,328

 

 

$

2,329

 

Operating expenses

 

12,707

 

 

 

13,881

 

 

 

13,890

 

Total amortization expense

$

14,345

 

 

$

16,209

 

 

$

16,219

 

     

(3)

Acquisition related depreciation expense included in these    
amounts is as follows:    
Cost of product revenue

$

3

 

 

$

4

 

 

$

3

 

Cost of service revenue

 

2

 

 

 

3

 

 

 

3

 

Research and development

 

42

 

 

 

45

 

 

 

41

 

Sales and marketing

 

8

 

 

 

9

 

 

 

7

 

General and administrative

 

4

 

 

 

4

 

 

 

4

 

Total acquisition related depreciation expense

$

59

 

 

$

65

 

 

$

58

 

     

(4)

Legal expenses related to civil judgments included in this    
amount is as follows:    
General and administrative

$

41

 

 

$

 

 

$

50

 

Total legal judgments expense

$

41

 

 

$

 

 

$

50

 

     

(5)

Change in fair value of derivative instrument included in    
this amount is as follows:    
Interest and other (income) expense, net

$

(206

)

 

$

 

 

$

1,380

 

Total change in fair value of derivative instrument

$

(206

)

 

$

 

 

$

1,380

 

     

(6)

Total income tax adjustment included in this    
amount is as follows:    
Tax effect of non-GAAP adjustments above

$

(7,171

)

 

$

(8,445

)

 

$

(2,041

)

Total income tax adjustments

$

(7,171

)

 

$

(8,445

)

 

$

(2,041

)

NETSCOUT SYSTEMS, INC.
Reconciliation of Current GAAP to Current and Historical Non-GAAP Financial Measures –
Non-GAAP EBITDA from Operations
(In thousands)
(Unaudited)
   
   

Three Months Ended

 

Three Months Ended

June 30,   March 31,

 

2023

 

 

 

2022

 

 

 

2023

 

   
Income (loss) from operations (GAAP)

$

(4,695

)

 

$

(9,127

)

 

$

1,638

 

Previous adjustments to determine non-GAAP income from operations

 

34,289

 

 

 

33,629

 

 

 

31,067

 

Non-GAAP Income from operations

 

29,594

 

 

 

24,502

 

 

 

32,705

 

   
Depreciation excluding acquisition related-depreciation expense

 

5,032

 

 

 

5,311

 

 

 

5,339

 

   
Non-GAAP EBITDA from operations

$

34,626

 

 

$

29,813

 

 

$

38,044

 

Non-GAAP EBITDA from operations as a % of revenue

 

16.4

%

 

 

14.3

%

 

 

18.3

%

NETSCOUT SYSTEMS, INC.
Reconciliation of GAAP Financial Outlook to Non-GAAP Financial Outlook
(Unaudited)
(In millions, except net income per share – diluted)
 
FY’23 FY’24
GAAP & Non-GAAP revenue

$

914.5

 

~$915 million to ~$945 million
 
FY’23 FY’24
GAAP net income

$

59.6

 

~$64 million to ~$73 million
Amortization of intangible assets

$

64.7

 

~$57 million
Share-based compensation expenses

$

62.0

 

~$69 million
Business development & integration expenses*

$

0.2

 

~Less than $1 million
Change in fair value of derivative instrument

$

1.4

 

Legal expenses related to civil judgments

$

0.5

 

Restructuring charges

$

1.8

 

Total adjustments

$

130.6

 

~$127 million
Related impact of adjustments on income tax

$

(30.7

)

(~$27 million)
Non-GAAP net income

$

159.6

 

~$164 million to ~$173 million
 
GAAP net income per share (diluted)

$

0.82

 

~$0.86 to ~$0.98
Non-GAAP net income per share (diluted)

$

2.18

 

~$2.20 to ~$2.32
 
Average weighted shares outstanding (diluted GAAP)

 

73.0

 

~74 million to ~75 million
Average weighted shares outstanding (diluted Non-GAAP)

 

73.0

 

~74 million to ~75 million
*Business development & integration expenses include acquisition-related depreciation expense
**Figures in table may not total due to rounding

 

Investors

Anthony Piazza

Senior Vice President, Corporate Finance

978-614-4286

[email protected]

Media

Maribel Lopez

Manager, Marketing & Corporate Communications

781-362-4330

[email protected]

KEYWORDS: Massachusetts United States North America

INDUSTRY KEYWORDS: Technology VoIP Telecommunications Software Networks Internet

MEDIA:

SIGA Technologies to Host Business Update Call on Tuesday, August 8th, 2023 Following Release of Second Quarter 2023 Financial Results

NEW YORK, July 27, 2023 (GLOBE NEWSWIRE) — SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage pharmaceutical company, today announced that management will host a webcast and conference call to provide a business update at 4:30 P.M. ET on Tuesday, August 8th, 2023. Participating on the call will be Dr. Phil Gomez, Chief Executive Officer, Dr. Dennis Hruby, Chief Scientific Officer, and Daniel Luckshire, Chief Financial Officer.

A live webcast of the call will also be available on the Company’s website at www.siga.com under the ‘Events & Presentations’ tab in the Investor Relations section, or by clicking here. Please log in approximately 5-10 minutes prior to the scheduled start time.

Participants may access the call by dialing 1-888-304-1803 for domestic callers or 1-848-488-9277 for international callers.

A replay of the call will be available for two weeks by dialing 1-844-512-2921 for domestic callers or 1-412-317-6671 for international callers and using Conference ID: 153003. The archived webcast will be available in the Events and Presentations section of the Company’s website.

ABOUT SIGA TECHNOLOGIES, INC. and TPOXX®

SIGA Technologies, Inc. is a commercial-stage pharmaceutical company focused on the health security market. Health security comprises countermeasures for biological, chemical, radiological and nuclear attacks (biodefense market), vaccines and therapies for emerging infectious diseases, and health preparedness. Our lead product is TPOXX®, also known as tecovirimat and ST-246®, an orally administered and IV formulation antiviral drug for the treatment of human smallpox disease caused by variola virus. TPOXX is a novel small-molecule drug and the US maintains a supply of TPOXX under Project BioShield. The oral formulation of TPOXX was approved by the FDA for the treatment of smallpox in 2018, and the IV formulation was approved for the same indication in 2022. The full label is available by clicking here. Oral tecovirimat received approval from the European Medicines Agency (EMA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom in 2022. The EMA and UK approvals include labeling for oral tecovirimat indicating its use for the treatment of smallpox, monkeypox, cowpox, and vaccinia complications following vaccination against smallpox. The full label is available by clicking here. In September 2018, SIGA signed a contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, for additional procurement and development related to both oral and intravenous formulations of TPOXX. For more information about SIGA, please visit www.siga.com.

About Smallpox

Smallpox is a contagious, disfiguring and often deadly disease that has affected humans for thousands of years. Naturally-occurring smallpox was eradicated worldwide by 1980, the result of an unprecedented global immunization campaign. Samples of smallpox virus have been kept for research purposes. This has led to concerns that smallpox could someday be used as a biological warfare agent. A vaccine can prevent smallpox, but the risk of the current vaccine’s side effects is too high to justify routine vaccination for people at low risk of exposure to the smallpox virus.

FORWARD-LOOKING STATEMENTS

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements relating to the progress of SIGA’s development programs and timelines for bringing products to market, delivering products to the Strategic Stockpile, the enforceability of our procurement contracts, such as the 19C BARDA Contract (the “BARDA Contract”), with BARDA, the impact of the COVID pandemic and responding to the global outbreak of monkeypox. The words or phrases “can be,” “expects,” “may affect,” “may depend,” “believes,” “estimate,” “project” and similar words and phrases are intended to identify such forward-looking statements. Such forward-looking statements are subject to various known and unknown risks and uncertainties, and SIGA cautions you that any forward-looking information provided by or on behalf of SIGA is not a guarantee of future performance. SIGA’s actual results could differ materially from those anticipated by such forward-looking statements due to a number of factors, some of which are beyond SIGA’s control, including, but not limited to, (i) the risk that BARDA elects, in its sole discretion as permitted under the BARDA Contract, not to exercise all, or any, of the remaining unexercised options under those contracts, (ii) the risk that SIGA may not complete performance under the BARDA Contract on schedule or in accordance with contractual terms, (iii) the risk that the BARDA Contract, the current Department of Defense procurement contract or PEP Label Expansion R&D Contract (as defined in the Form 10-Q) are modified or canceled at the request or requirement of the U.S. Government, (iv) the risk that the nascent international biodefense market does not develop to a degree that allows SIGA to continue to successfully market TPOXX® internationally, (v) the risk that potential products, including potential alternative uses or formulations of TPOXX® that appear promising to SIGA or its collaborators, cannot be shown to be efficacious or safe in subsequent pre-clinical or clinical trials, (vi) the risk that SIGA or its collaborators will not obtain appropriate or necessary governmental approvals to market these or other potential products or uses, (vii) the risk that SIGA may not be able to secure or enforce sufficient legal rights in its products, including intellectual property protection, (viii) the risk that any challenge to SIGA’s patent and other property rights, if adversely determined, could affect SIGA’s business and, even if determined favorably, could be costly, (ix) the risk that regulatory requirements applicable to SIGA’s products may result in the need for further or additional testing or documentation that will delay or prevent SIGA from seeking or obtaining needed approvals to market these products, (x) the risk that the volatile and competitive nature of the biotechnology industry may hamper SIGA’s efforts to develop or market its products, (xi) the risk that changes in domestic or foreign economic and market conditions may affect SIGA’s ability to advance its research or may affect its products adversely, (xii) the effect of federal, state, and foreign regulation, including drug regulation and international trade regulation, on SIGA’s businesses, (xiii) the risk of disruptions to SIGA’s supply chain for the manufacture of TPOXX®, causing delays in SIGA’s research and development activities, causing delays or the re-allocation of funding in connection with SIGA’s government contracts, or diverting the attention of government staff overseeing SIGA’s government contracts, (xiv) the risk that the U.S. or foreign governments’ responses (including inaction) to national or global economic conditions or infectious diseases, such as COVID-19, are ineffective and may adversely affect SIGA’s business, and (xv) risks associated with responding to the current monkeypox outbreak, as well as the risks and uncertainties included in Item 1A “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2022 and SIGA’s subsequent filings with the Securities and Exchange Commission. SIGA urges investors and security holders to read those documents free of charge at the SEC’s website at http://www.sec.gov. All such forward-looking statements are current only as of the date on which such statements were made. SIGA does not undertake any obligation to update publicly any forward-looking statement to reflect events or circumstances after the date on which any such statement is made or to reflect the occurrence of unanticipated events.

Contacts:

Investor Contact

Laine Yonker, Edison Group
[email protected]

Public Relations

Holly Stevens, Berry & Company
[email protected]



Accel Entertainment, Inc. to Announce Second Quarter 2023 Financial Results

Accel Entertainment, Inc. to Announce Second Quarter 2023 Financial Results

CHICAGO–(BUSINESS WIRE)–
Accel Entertainment, Inc. (NYSE: ACEL) today announced it will release its financial and operating results for the second quarter ended June 30, 2023, after market close on August 3, 2023. The company will host a conference call at 5:30 PM ET / 4:30 PM CT that same day to discuss these results.

Interested parties may join the live webcast by registering at https://www.netroadshow.com/events/login?show=b22ebdaa&confId=52872. Registering in advance of the call will provide listeners with a personalized link to view the webcast and an individual dial-in for the call. This registration link to the live webcast, as well as a replay following the call, will also be available on Accel’s investor relations website: https://ir.accelentertainment.com.

About Accel

Accel believes it is the leading distributed gaming operator in the United States on an Adjusted EBITDA basis, and a preferred partner for local business owners in the markets Accel serves. Accel’s business primarily consists of the installation, maintenance and operation of gaming terminals, redemption devices that disburse winnings and contain automated teller machine (ATM) functionality, and other amusement devices in authorized non-casino locations such as restaurants, bars, taverns, convenience stores, liquor stores, truck stops, and grocery stores.

Media:

Eric Bonach

H/Advisors Abernathy

212-371-5999

[email protected]

KEYWORDS: United States North America Illinois

INDUSTRY KEYWORDS: Casino/Gaming Other Entertainment Entertainment

MEDIA:

Logo
Logo

Vision Marine Technologies Sets Industry Precedence Through Pioneering Partnership with 4ocean

MONTREAL, July 27, 2023 (GLOBE NEWSWIRE) — Vision Marine Technologies Inc. (NASDAQ: VMAR) (“Vision Marine” or the “Company”), a global leader and innovator within the performance electric recreational boating industry, is once again taking the lead by blazing a trail for the entire industry. The Company proudly announces its groundbreaking collaboration with 4ocean, a global cleanup operation actively removing plastic and trash from the ocean and coastlines. Through this visionary partnership, Vision Marine is spearheading the way forward for the entire industry, demonstrating a profound commitment to environmental stewardship.

As a Certified Cleanup Partner, Vision Marine cements its position as a trailblazer, forging an alliance that not only showcases its dedication to sustainable boating solutions but also illuminates the path for the entire industry to follow. By joining forces with 4ocean (https://www.4ocean.com/), the vanguard of the clean ocean movement, Vision Marine is driving a transformative initiative to eliminate plastic waste from our oceans, rivers, and coastlines on a global scale.

Alex Mongeon, co-founder and CEO of Vision Marine, emphasized the Company’s purposeful leadership, stating, “Vision Marine is determined to lead the way towards a greener future for the boating industry. Our partnership with 4ocean exemplifies our commitment to environmental preservation and signifies a new era of collaboration, where companies unite to tackle the critical issue of ocean pollution. We are proud to set a precedent for the industry and showcase how businesses can drive positive change for the planet.”

As the visionary force behind the clean ocean movement, Alex Schulze, co-founder and CEO of 4ocean, expressed his admiration for Vision Marine’s pioneering approach, stating, “It takes true leadership and dedication to ignite change on a global scale. We are thrilled to have Vision Marine as a Certified Cleanup Partner, demonstrating their passion for the oceans and inspiring others in the industry to follow suit. Together, we are charting a course towards a cleaner and healthier marine ecosystem.”

This revolutionary partnership solidifies Vision Marines’ long-term commitment to sustainable business practices and environmental conservation, setting a powerful example for the industry at large. By embarking on this transformative journey with 4ocean, Vision Marine aims to spark a profound impact, encouraging other companies and individuals to unite in safeguarding the future of our oceans.

About 4ocean

4ocean is an ocean cleanup company in Boca Raton, FL, which is dedicated to ending the ocean plastic crisis. As a Public Benefit Corporation and Certified B Corp., they harness the power of business to fund global cleanup operation that recovers millions of pounds of plastic and other debris from the world’s oceans, rivers, and coastlines each year. Contact: Jonathan Marshall, PR Specialist ([email protected])

Learn More

Website: 4ocean.com
Twitter: @4ocean
Facebook: @4oceanBracelets
Instagram: @4ocean
TikTok: @4ocean

About Vision Marine Technologies Inc.

Vision Marine Technologies Inc. (Nasdaq: VMAR), strives to be a guiding force for change and an ongoing driving factor in fighting the problems associated with waterway pollution by disrupting the traditional boating industry with electric power, in turn directly contributing to zero pollution, zero emission and a noiseless environment. Our Flagship E-Motion™ 180E electric marine powertrain is the first fully electric purpose-built outboard powertrain system that combines an advanced battery pack, inverter, and high efficiency motor with proprietary union assembly between the transmission and the electric motor design utilizing extensive control software. Our E-Motion™ and related technologies used in this powertrain system are uniquely designed to improve the efficiency of the outboard powertrain and, as a result, enhance both range and performance. Vision Marine continues to design, innovate, manufacture, and sell handcrafted, environmentally friendly, electric recreational boats to customers. The design and technology applied to our boats results in far greater enhanced performance in general, higher speeds, and longer range. Simply stated, a smoother ride than a traditional internal combustion engine (ICE) motorboat.

Forward-Looking Statements 

Certain statements made in this press release are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “expect,” “estimate,” “plan,” “outlook,” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, actual results may differ materially from these expectations due to changes in global, regional, or local economic, business, competitive, market, regulatory and other factors, many of which are outside of Vision Marine’s control. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in Vision Marine’s Annual Report on Form 20-F, filed with the U.S. Securities and Exchange Commission (SEC) for the year ended August 31, 2022, as such factors may be updated from time to time in Vision Marine’s periodic filings with the SEC. Any forward-looking statement in this press release speaks only as of the date of this release. Vision Marine undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. https://visionmarinetechnologies.com.

Investor and Company Contact: Bruce Nurse

303-919-2913 or

[email protected]