MCLEAN, Va., June 7, 2023 /PRNewswire/ — V2X, Inc. (NYSE: VVX) was awarded a position on the Training Systems Acquisition IV (TSA IV) program with the United States Air Force. The multiple award, indefinite-delivery/indefinite-quantity contract vehicle is valued up to $32.5 billion over ten-years, including all option periods. The contract aids in the development, installation, and long-term support of cutting-edge training systems designed for aircrew, maintenance personnel, and system-specific training. These systems are instrumental in enhancing global warfighter training efforts.
V2X wins seat on $32.5bn US Air training systems contract
“This partnership enables us to develop, install, and provide long-term support for cutting-edge technologies that shape the future of warfighter training,” said Chuck Prow, V2X President and CEO. “This win provides an opportunity for V2X to leverage its decades of Army training expertise to now deliver innovative training solutions to the Air Force. V2X is well-positioned to modernize system-specific training that enhances the capabilities and readiness of the Air Force and our armed forces.”
Benefiting from the collaboration of V2X and 36 other industry leaders, the Air Force will be able to significantly enhance its training programs and empower its personnel with the skills and knowledge to excel in their missions.
About V2X
V2X builds smart solutions designed to integrate physical and digital infrastructure – from base to battlefield – by aligning people, actions, and outputs. Formed by the merger of Vectrus and Vertex, we bring a combined 120 years of successful mission support. Our lifecycle solutions improve security, streamline logistics, and enhance readiness.
The Company delivers a comprehensive suite of integrated solutions across the operations and logistics, aerospace, training, and technology markets to national security, defense, civilian and international clients. Our global team of approximately 15,000 employees brings innovation to every point in the mission lifecycle, from preparation to operations, to sustainment, as it tackles the most complex challenges with agility, grit, and dedication.
Media Contact Angelica Spanos Deoudes Senior Media Strategist [email protected] 571-338-5195
Investor Contact Mike Smith, CFA Vice President, Treasury, Corporate Development and Investor Relations [email protected] 571-337-3862
TORONTO, ON / ACCESSWIRE / June 7, 2023 / Eskay Mining Corp. (“Eskay” or the “Company”) (TSXV:ESK) (OTCQX:ESKYF) (Frankfurt:KN7)(WKN:A0YDPM) wishes to announcethat, further to its News Release of November 12, 2021, Eskay, Seabridge Gold Inc. (“Seabridge”) and Seabridge’s wholly-owned subsidiary, KSM Mining ULC (“KSM”), have signed an agreement (the “Termination and Mutual Release Agreement”) to terminate the amended agreement (the “Amended Cost Sharing Agreement”) whereby Seabridge and Eskay were to fund the costs of construction of the first 9 kilometres (the “First Segment of the CCAR”) of the Coulter Creek Access Road (“CCAR”), estimated to cost $12.5 million, with a limit on Eskay’s contribution to a maximum of $6,250,000. Seabridge provided Eskay with a $3 million revolving loan facility at an interest rate of 3% per year to give Eskay flexibility with funding its share of the costs of construction.
At the end of 2022, the costs incurred in respect of the construction of the First Segment of the CCAR were approximately $6 million. Seabridge had suspended delivering cash calls before year end and Eskay’s share of cash calls to year end was funded through the drawdown of approximately $2.7 million of the loan facility provided by Seabridge pursuant to the Amended Cost Sharing Agreement. Seabridge completed 3.2 km of the road in 2022 and due to Seabridge concentrating its current road building activities on its Treaty Creek Access Road, it is uncertain when Seabridge will complete the First Segment of the CCAR.
Eskay will not have access to or use of the First Segment of the CCAR for its 2023 exploration program. Therefore, Eskay, Seabridge and KSM agreed to terminate the Amended Cost Sharing Agreement and release each other from all obligations under the Amended Cost Sharing Agreement including any obligations relating to the completion of the First Segment of the CCAR, any obligation of Eskay to contribute to construction costs relating to the First Segment of the CCAR or any obligation of Seabridge to provide further loans or of Eskay to repay loans provided by Seabridge, or interest thereon. In addition, the 500,000 Bonus Warrants issued to Seabridge were cancelled.
Pursuant to the terms of the Termination and Mutual Release Agreement, Eskay will have the right after completion of the First Segment of the CCAR, as long as KSM or its assignee operates the relevant CCAR segment, to request a road use agreement for the use of the First Segment of the CCAR. Pursuant to the terms of the road use agreement, Eskay will be required to pay an industry standard portion of maintenance costs and $100,000 per year for up to eight years (which may be non-consecutive years) for use of the First Segment of the CCAR.
About Eskay Mining Corp:
Eskay Mining Corp (TSX-V:ESK) is a TSX Venture Exchange listed company, headquartered in Toronto, Ontario. Eskay is an exploration company focused on the exploration and development of precious and base metals along the Eskay rift in a highly prolific region of northwest British Columbia known as the “Golden Triangle,” 70km northwest of Stewart, BC. The Company currently holds mineral tenures in this area comprised of 177 claims (52,600 hectares).
All material information on the Company may be found on its website at www.eskaymining.com and on SEDAR at www.sedar.com.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Forward-Looking Statements: This Press Release contains forward-looking statements that involve risks and uncertainties, which may cause actual results to differ materially from the statements made. When used in this document, the words “may”, “would”, “could”, “will”, “intend”, “plan”, “anticipate”, “believe”, “estimate”, “expect” and similar expressions are intended to identify forward-looking statements. Such statements reflect our current views with respect to future events and are subject to risks and uncertainties. Many factors could cause our actual results to differ materially from the statements made, including those factors discussed in filings made by us with the Canadian securities regulatory authorities. Should one or more of these risks and uncertainties, such as actual results of current exploration programs, the general risks associated with the mining industry, the price of gold and other metals, currency and interest rate fluctuations, increased competition and general economic and market factors, occur or should assumptions underlying the forward looking statements prove incorrect, actual results may vary materially from those described herein as intended, planned, anticipated, or expected. We do not intend and do not assume any obligation to update these forward-looking statements, except as required by law. Shareholders are cautioned not to put undue reliance on such forward-looking statements.
IRVING, Texas–(BUSINESS WIRE)– Salem Media Group, Inc. (NASDAQ: SALM) announced today that the “Main Street Matters” podcast, produced by Job Creators Network, will join the Salem Podcast Network, effective June 7, 2023.
Main Street Matters is America’s small business megaphone and will feature inspirational real-life stories of the struggles and successes of small business owners. By highlighting their grit, determination, and passion Main Street Matters will prove the American Dream is still alive. The podcast will be co-hosted by Alfredo Ortiz, President and CEO of Job Creators Network, and Elaine Parker, President of Job Creators Network Foundation. Two episodes of the podcast will be released each week.
“We are so happy to add a podcast to our lineup that talks to small business owners and entrepreneurs — the lifeblood of the economy,” said Salem Senior Vice President of Spoken Word, Phil Boyce. “Alfredo and Elaine are two of the best voices out there in this space and will be able to help so many people grow and succeed.”
“Job Creators Network is proud to partner with Salem to launch this important podcast,” said Alfredo Ortiz. “‘Main Street Matters’ will elevate the concerns of small business job creators and promote the positive American vision of entrepreneurship. This small business message is needed now to counter big government narratives and policies.”
“Small businesses are the backbone of the American economy, yet they are under constant pressure from bad government policy,” said Elaine Parker. “Job Creators Network is excited to tell their stories in the new podcast, ‘Main Street Matters’, to build public support for policies that help them flourish. We are excited to partner with Salem, the premiere audio distribution channel of conservative thought.”
The Job Creators Network (JCN) is the country’s leading organization fighting for economic freedom by advocating for pro-growth policies and pushing back against government overreach. JCN provides business and community leaders with the tools and training to become an effective voice for free enterprise in the media, in Congress, in state capitals, and with their employees. By creating advocates, we can hold politicians accountable and reduce the efforts of big government to over-regulate and overtax America’s small business owners.
As the president and CEO of the Job Creators Network, Alfredo Ortiz has led the defense of small businesses from the onslaught of bad government policies. He has testified before legislative committees about the impact of taxation and regulation on small business growth. He served as a Commissioner to the White House Hispanic Prosperity Initiative. Ortiz was instrumental in helping pass the historic tax cuts bill of 2017. Before joining JCN, Ortiz was a marketing and corporate strategy consultant, working for various Fortune 500 companies. He has been widely published in major media outlets, including The Wall Street Journal, USA Today, CNBC, The Hill, and U.S. News & World Report and is a frequent guest on cable news networks and national radio talk shows, including CNN, Fox News, Hugh Hewitt, Mike Gallagher, and the Dennis Prager Show as well as C-SPAN. Ortiz received his MBA at the University of Michigan and graduated from Pomona College with a bachelor’s degree in economics.
Elaine Parker has more than 20 years of experience in the communications field, beginning her career as a Public Relations Manager for Chrysler. She later became an independent communications consultant specializing in public policy advocacy, media strategies, and crisis communications. In her roles with the Job Creators Network and the Job Creators Network Foundation, she frequently appears as a guest on television and nationally syndicated radio shows and has published op-eds in FoxNews.com, Washington Examiner, Los Angeles Daily News, RealClear Policy, Townhall, The Hill, The Orange County Register, the Orlando Sentinel and other national publications. Parker is a graduate of the University of Central Florida, where she studied Business Administration.
The Salem Podcast network launched in January 2021 and is ranked as the 10th most listened to podcast network on the Triton Digital platform, with 17 million average downloads per month.
ABOUT SALEM MEDIA GROUP:
Salem Media Group is America’s leading multimedia company specializing in Christian and conservative content, with media properties comprising radio, digital media and book and newsletter publishing. Each day Salem serves a loyal and dedicated audience of listeners and readers numbering in the millions nationally. With its unique programming focus, Salem provides compelling content, fresh commentary and relevant information from some of the most respected figures across the Christian and conservative media landscape. Learn more about Salem Media Group, Inc. at www.salemmedia.com, Facebook and Twitter.
Net loss totaled ($4.7) million, or ($0.15) per diluted share; non-GAAP net loss totaled ($2.6) million, or ($0.09) per diluted share
Balance sheet remains strong, with cash and cash equivalents of $25.3 million, no debt, and year-over-year inventories down 11.8%
Management increases guidance for fiscal year
FORT WAYNE, Ind., June 07, 2023 (GLOBE NEWSWIRE) — Vera Bradley, Inc. (Nasdaq: VRA) today announced its financial results for the first quarter ended April 29, 2023.
In this release, Vera Bradley, Inc. or “the Company” refers to the entire enterprise and includes both the Vera Bradley and Pura Vida brands. Vera Bradley on a stand-alone basis refers to the Vera Bradley brand.
First Quarter Comments
Jackie Ardrey, Chief Executive Officer of the Company, noted, “We are pleased that meaningful gross margin expansion and diligent expense control led to significant year-over-year improvement in bottom-line performance for the quarter.
“On the revenue side, Vera Bradley factory stores experienced challenging traffic trends in March and April that led to weaker-than-expected performance for the quarter. This was partially offset, however, by several positive highlights in other areas of our business.
“First, we experienced our first positive quarterly revenue performance in five quarters at Pura Vida, primarily driven by non-comparable retail store sales. We also saw improved year-over-year sales trends in both our Pura Vida wholesale and e-commerce channels. Second, we delivered strong Vera Bradley e-commerce performance and solid Vera Bradley full-line store revenues. Vera Bradley Indirect revenues declined, as expected, due to a non-recurring key account order that took place in last year’s first quarter, but the underlying business remains healthy.”
“We are building a collaborative team with the mindset of generating long-term revenue increases, expanding gross margin, and ensuring strong financial discipline and cost control, which we expect will drive long-term profitable growth,” Ardrey continued. “The team is working hard and taking strategic, proactive steps to steadily grow Pura Vida’s revenues and to reverse the trends in Vera Bradley’s factory channel through the expansion of successfully tested targeted marketing programs designed to drive traffic and average order size.”
Ardrey added, “The hard work on Project Restoration began in the first quarter, which is focused on four key pillars of the business for each brand – Consumer, Brand, Product, and Channel – to drive this long-term profitable growth. To support Project Restoration and lay the foundation for our success, we made additional corporate changes and announced $12 million in incremental annualized cost reductions, including the elimination of approximately 25 corporate positions as part of an overall plan to further right-size the expense structure of the Company.”
Michael Schwindle joined the Company as Chief Financial Officer on May 8, 2023. “His track record of driving profitable growth, along with his passion for retail and operational excellence, will be instrumental as the Company executes Project Restoration and in the years beyond,” Ardrey noted. The Company also made several organizational changes in the Marketing, E-commerce, Product Design, and Product Development areas that flattened and streamlined the organizational structure to improve execution; make faster decisions; and provide support for the four pillars of Project Restoration. These most recent organizational changes and non-payroll expense reductions are expected to produce annualized savings of approximately $12 million, on top of the Company’s Fiscal 2023 cost reductions.
“We are committed to delivering improved value to our shareholders,” Ardrey continued. “These efforts will allow us to simplify our structure, be a more agile organization, and reset our expense base, so we can focus fully on Project Restoration and on delivering both healthy top- and bottom-line growth in the future.”
Summary of Financial Performance for the First Quarter
Consolidated net revenues totaled $94.4 million compared to $98.5 million in the prior year first quarter ended April 30, 2022.
For the current year first quarter, Vera Bradley, Inc.’s consolidated net loss totaled ($4.7) million, or ($0.15) per diluted share. These results included $2.0 million of net after tax charges, comprised of $1.4 million of severance charges, $0.5 million for the amortization of definite-lived intangible assets, and $0.1 million of consulting and professional fees primarily associated with cost saving and strategic initiatives. On a non-GAAP basis, Vera Bradley, Inc.’s consolidated first quarter net loss totaled ($2.6) million, or ($0.09) per diluted share.
For the prior year first quarter, Vera Bradley, Inc.’s consolidated net loss totaled ($7.0) million, or ($0.21) per diluted share. These results included $0.9 million of net after tax charges, comprised of $0.4 million of intangible asset amortization and $0.4 million of impairment charges, and $0.1 million of consulting fees associated with cost savings initiatives. On a non-GAAP basis, Vera Bradley, Inc.’s consolidated first quarter net loss totaled ($6.0) million, or ($0.18) per diluted share.
Non-GAAP Numbers
The current year non-GAAP first quarter income statement numbers referenced below exclude the previously outlined severance charges, intangible asset amortization, and consulting and professional fees. The prior year non-GAAP first quarter income statement numbers referenced below exclude the previously outlined intangible asset amortization, impairment charges, and consulting fees.
First Quarter Details
Current year first quarter Vera Bradley Direct segment revenues totaled $58.9 million, a 4.4% decrease from $61.6 million in the prior year first quarter. Comparable sales declined 3.3% in the first quarter, primarily due to weakness in the factory channel. The Company permanently closed 19 full-line and two factory outlet stores and opened five factory outlet stores over the last twelve months.
Vera Bradley Indirect segment revenues totaled $15.4 million, a 9.4% decrease from $17.0 million in the prior year first quarter. Prior year revenues reflected a large one-time key account order that was not repeated in the current year.
Pura Vida segment revenues totaled $20.1 million, a 1.2% increase over $19.8 million in the prior year first quarter, primarily driven by new store growth resulting in non-comparable retail store sales.
First quarter consolidated gross profit totaled $51.7 million, or 54.8% of net revenues, compared to $52.5 million, or 53.3% of net revenues, in the prior year first quarter. The current year gross profit rate was favorably impacted by lower year-over-year inbound and outbound freight expense and the sell-through of previously-reserved inventory, partially offset by an increase in promotional activity.
Consolidated SG&A expense totaled $58.5 million, or 62.0% of net revenues, for the quarter, compared to $60.9 million, or 61.9% of net revenues, for the prior year first quarter. On a non-GAAP basis, consolidated SG&A expense totaled $55.6 million, or 58.9% of net revenues, for the current quarter, compared to $59.4 million, or 60.3% of net revenues, for the prior year first quarter. Vera Bradley’s current year non-GAAP SG&A expenses were lower than the prior year primarily due to cost reduction initiatives and a reduction in variable-related expenses related to lower sales volume.
The Company’s first quarter consolidated operating loss totaled ($6.4) million, or (6.8%) of net revenues, compared to an operating loss of ($8.2) million, or (8.4%) of net revenues, in the prior year first quarter. On a non-GAAP basis, the consolidated operating loss totaled ($3.5) million, or (3.7%) of net revenues, compared to ($6.7) million, or (6.8%) of net revenues, in the prior year.
By segment:
Vera Bradley Direct’s first quarter operating income was $7.3 million, or 12.5% of Direct net revenues, compared to operating income of $5.5 million, or 8.9% of Direct net revenues, in the prior year. On a non-GAAP basis, Vera Bradley Direct’s current year first quarter operating income was $7.7 million, or 13.0% of Direct net revenues, compared to $5.5 million, or 8.9% of Direct net revenues, in the prior year.
Vera Bradley Indirect’s first quarter operating income was $4.7 million, or 30.6% of Indirect net revenues, compared to $5.5 million, or 32.3% of Indirect net revenues, in the prior year.
Pura Vida’s first quarter operating income was $1.6 million, or 7.8% of Pura Vida net revenues, compared to $1.1 million, or 5.3% of Pura Vida net revenues, in the prior year. On a non-GAAP basis, Pura Vida’s current year first quarter operating income was $2.3 million, or 11.4% of Pura Vida net revenues, compared to $1.8 million, or 9.2% of Pura Vida net revenues, in the prior year.
Balance Sheet
Net capital spending for the first quarter totaled $0.8 million compared to $1.7 million in the prior year.
Cash and cash equivalents as of April 29, 2023 totaled $25.3 million compared to $46.6 million at fiscal year end. The Company had no borrowings on its $75 million ABL credit facility at quarter end.
Total quarter-end inventory was $142.7 million, compared to $161.8 million at the end of the first quarter last year.
During the first quarter, the Company repurchased approximately $0.7 million of its common stock (approximately 0.1 million shares at an average price of $5.71). $27.0 million remains under the Company’s $50.0 million repurchase authorization that expires in December 2024.
Forward Outlook
Management is updating guidance for the fiscal year ending February 3, 2024 (“Fiscal 2024”) based on first quarter performance, Company initiatives underway, and current macroeconomic trends and expectations.
Excluding net revenues, all forward-looking guidance numbers referenced below are non-GAAP. The prior year income statement numbers exclude the previously disclosed charges for goodwill and intangible asset impairment; net inventory and purchase order-related adjustments; severance, retention, and stock-based retirement compensation; consulting and professional fees primarily associated with cost savings initiatives, the CEO search, and strategic initiatives; amortization of definite-lived intangible assets; store and right-of-use asset impairment charges; new CEO sign-on bonus and relocation; and goodMRKT exit costs. Current year guidance excludes any similar charges.
For Fiscal 2024, the Company’s expectations are as follows:
Consolidated net revenues of $490 to $510 million. Net revenues totaled $500.0 million in Fiscal 2023. Both Vera Bradley and Pura Vida revenues are expected to be approximately flat on a year-over-year basis.
A consolidated gross profit percentage of 52.8% to 53.8% compared to 51.4% in Fiscal 2023. The Fiscal 2024 gross margin rate is expected to be favorably impacted by lower year-over-year freight expense, cost reduction initiatives, and the sell-through of previously-reserved inventory, partially offset by an increase in promotional activity.
Consolidated SG&A expense of $237 to $247 million compared to $245.3 million in Fiscal 2023. An expected decline in SG&A expense is being driven by Company-wide cost reduction initiatives, partially offset by restoring short-term and long-term incentive compensation to more normalized levels and incremental marketing investment intended to accelerate customer file growth.
Consolidated operating income of $24 to $28 million compared to $12.3 million in Fiscal 2023.
Free cash flow of between $35 and $40 million compared to a cash usage of $21.7 million in Fiscal 2023.
Consolidated diluted EPS of $0.57 to $0.67 based on diluted weighted-average shares outstanding of 30.7 million and an effective tax rate of approximately 28%. Diluted EPS totaled $0.24 last year.
Net capital spending of approximately $5 million compared to $8.2 million in the prior year, reflecting investments associated with new Vera Bradley Factory stores and technology and logistics enhancements.
Disclosure Regarding Non-GAAP Measures
The Company’s management does not, nor does it suggest that investors should, consider the supplemental non-GAAP financial measures in isolation from, or as a substitute for, financial information prepared in accordance with accounting principles generally accepted in the United States (“GAAP”). Further, the non-GAAP measures utilized by the Company may be unique to the Company, as they may be different from non-GAAP measures used by other companies.
The Company believes that the non-GAAP measures presented in this earnings release, including (cash usage) free cash flow; gross profit; selling, general, and administrative expenses; operating loss; net loss; net loss attributable and available to Vera Bradley, Inc.; and diluted net loss per share available to Vera Bradley, Inc. common shareholders, along with the associated percentages of net revenues, are helpful to investors because they allow for a more direct comparison of the Company’s year-over-year performance and are consistent with management’s evaluation of business performance. A reconciliation of the non-GAAP measures to the most directly comparable GAAP measures can be found in the Company’s supplemental schedules included in this earnings release.
Call Information
A conference call to discuss results for the first quarter is scheduled for today, Wednesday, June 7, 2023, at 9:30 a.m. Eastern Time. A broadcast of the call will be available via Vera Bradley’s Investor Relations section of its website, www.verabradley.com. Alternatively, interested parties may dial into the call at (888) 394-8218, and enter the access code 9903988. A replay will be available shortly after the conclusion of the call and remain available through June 21, 2023. To access the recording, listeners should dial (844) 512-2921, and enter the access code 9903988.
About Vera Bradley, Inc.
Vera Bradley, Inc. operates two unique lifestyle brands – Vera Bradley and Pura Vida. Vera Bradley and Pura Vida are complementary businesses, both with devoted, emotionally-connected, and multi-generational female customer bases; alignment as casual, comfortable, affordable, and fun brands; positioning as “gifting” and socially-connected brands; strong, entrepreneurial cultures; a keen focus on community, charity, and social consciousness; multi-channel distribution strategies; and talented leadership teams aligned and committed to the long-term success of their brands.
Vera Bradley, based in Fort Wayne, Indiana, is a leading designer of women’s handbags, luggage and other travel items, fashion and home accessories, and unique gifts. Founded in 1982 by friends Barbara Bradley Baekgaard and Patricia R. Miller, the brand is known for its innovative designs, iconic patterns, and brilliant colors that inspire and connect women unlike any other brand in the global marketplace.
In July 2019, Vera Bradley, Inc. acquired a 75% interest in Creative Genius, Inc., which also operates under the name Pura Vida Bracelets (“Pura Vida”). Pura Vida, based in La Jolla, California, is a digitally native, highly-engaging lifestyle brand founded in 2010 by friends Paul Goodman and Griffin Thall. Pura Vida has a differentiated and expanding offering of bracelets, jewelry, and other lifestyle accessories. The Company acquired the remaining 25% of Pura Vida in January 2023.
The Company has three reportable segments: Vera Bradley Direct (“VB Direct”), Vera Bradley Indirect (“VB Indirect”), and Pura Vida. The VB Direct business consists of sales of Vera Bradley products through Vera Bradley Full-Line and Factory stores in the United States, www.verabradley.com, www.verabradley.ca, Vera Bradley’s online outlet site, and the Vera Bradley annual outlet sale in Fort Wayne, Indiana. The VB Indirect business consists of sales of Vera Bradley products to approximately 1,700 specialty retail locations throughout the United States, as well as select department stores, national accounts, third party e-commerce sites, and third-party inventory liquidators, and royalties recognized through licensing agreements related to the Vera Bradley brand. The Pura Vida segment consists of sales of Pura Vida products through the Pura Vida websites, www.puravidabracelets.com, www.puravidabracelets.eu, and www.puravidabracelets.ca; through the distribution of its products to wholesale retailers and department stores; and through its Pura Vida retail stores.
Website Information
We routinely post important information for investors on our website www.verabradley.com in the “Investor Relations” section. We intend to use this webpage as a means of disclosing material, non-public information and for complying with our disclosure obligations under Regulation FD. Accordingly, investors should monitor the Investor Relations section of our website, in addition to following our press releases, SEC filings, public conference calls, presentations and webcasts. The information contained on, or that may be accessed through, our webpage is not incorporated by reference into, and is not a part of, this document.
Investors and other interested parties may also access the Company’s most recent Corporate Responsibility and Sustainability Report outlining its ESG (Environmental, Social, and Governance) initiatives at https://verabradley.com/pages/corporate-responsibility.
Vera Bradley Safe Harbor Statement
Certain statements in this release are “forward-looking statements” made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements reflect the Company’s current expectations or beliefs concerning future events and are subject to various risks and uncertainties that may cause actual results to differ materially from those that we expected, including: possible adverse changes in general economic conditions and their impact on consumer confidence and spending; possible inability to predict and respond in a timely manner to changes in consumer demand; possible loss of key management or design associates or inability to attract and retain the talent required for our business; possible inability to maintain and enhance our brands; possible inability to successfully implement the Company’s long-term strategic plans; possible inability to successfully open new stores, close targeted stores, and/or operate current stores as planned; incremental tariffs or adverse changes in the cost of raw materials and labor used to manufacture our products; possible adverse effects resulting from a significant disruption in our distribution facilities; or business disruption caused by pandemics. Risks, uncertainties, and assumptions also include the possibility that Pura Vida acquisition benefits may not materialize as expected and that Pura Vida’s business may not perform as expected. More information on potential factors that could affect the Company’s financial results is included from time to time in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of the Company’s public reports filed with the SEC, including the Company’s Form 10-K for the fiscal year ended January 28, 2023. We undertake no obligation to publicly update or revise any forward-looking statement. Financial schedules are attached to this release.
Research Directed by Faculty of the Center for Transplantation Sciences, Massachusetts General Hospital
TNX-1500 is Expected to Enter Phase 1 Clinical Development in Third Quarter 2023
CHATHAM, N.J, June 07, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced data from two oral presentations and one poster presentation at the 2023 American Transplant Congress (ATC) by faculty at the Center for Transplantation Sciences, Massachusetts General Hospital. The data involve studies of Tonix’s TNX-1500 (Fc-modified anti-CD40L monoclonal antibody) in development for the prevention of organ transplant rejection. The molecular target of TNX-1500 is CD40-ligand (CD40L), which is also known as CD154. Copies of the presentations are available on the Tonix Pharmaceuticals website at www.tonixpharma.com.
The oral presentations titled, “Fc-Modified anti-CD154 Mab Induced Long Term Renal Allograft Survival without Thromboembolic Complications” by Dr. Ryo Otsuka et al. and “Efficacy of CD154 Blockade with TNX-1500 to prevent heart allograft immune injury” by Dr. Ikechukwu Ileka et al., and the poster presentation titled “anti-CD154 mAb (TNX-1500) Alone, or in Combination with Rapamycin, MMF, or anti-CD28 mAb (VEL-101) Prolongs Cynomolgus Cardiac Allograft Survival” by Dr. Kohei Kinoshita et al. include data demonstrating that TNX-1500 showed activity in preventing organ rejection and was well tolerated in non-human primates. Blockade of CD40L with TNX-1500 monotherapy consistently prevented pathologic alloimmunity in non-human primate kidney and cardiac allograft models without clinical thrombosis. Dr. Kinoshita was recognized with “Poster of Distinction” for his poster presentation.
“The animal studies found that TNX-1500 retains activity to prevent rejection and preserve graft function, which we believe provides strong rationale for us to pursue development of TNX-1500 to prevent rejection in human transplant,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “We expect to begin a Phase 1 trial with TNX-1500 in the third quarter of 2023. There remains a significant need for new treatments with improved activity and tolerability to prevent organ transplant rejection. TNX-1500 is a third generation anti-CD40L mAb that has been designed by protein engineering to decrease FcγRII binding and to reduce the potential for thrombosis. We believe TNX-1500 has the potential for treating and preventing organ transplant rejection. Beyond transplantation, we believe TNX-1500 has potential for treating autoimmune conditions including systemic lupus erythematosus, Sjögren’s syndrome and multiple sclerosis.”
Tonix Pharmaceuticals Holding Corp.*
Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with topline data expected in the fourth quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 study has been completed, and topline results are expected in the third quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), in development for chronic migraine, is currently enrolling with topline data expected in the fourth quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets), a once-daily formulation being developed as a treatment for major depressive disorder (MDD), is also currently enrolling with interim data expected in the fourth quarter of 2023. TNX-4300 (estianeptine) is a small molecule oral therapeutic in preclinical development to treat MDD, Alzheimer’s disease and Parkinson’s disease. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the third quarter of 2023. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox, for which a Phase 1 study is expected to be initiated in the first quarter of 2024. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. The infectious disease portfolio also includes TNX-3900 and TNX-4000, classes of broad-spectrum small molecule oral antivirals.
*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.
This press release and further information about Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
Toronto, Ontario, June 6, 2023 – Aurania Resources Ltd. (TSXV: ARU; OTCQB: AUIAF; Frankfurt: 20Q) (“Aurania” or the “Company”) announces that its Annual and Special Meeting of Shareholders (the “Meeting”) will be held at 2:30pm EST on Wednesday, June 14, 2023 at the Company’s offices at 8 King Street East, Suite 1800, Toronto, ON M5C 1B5. The formal part of the Meeting will be followed by a brief presentation. Shareholders are invited to follow along the proceedings of the Meeting via Zoom Events. Questions may be posed in person at the Meeting or sent online during the Zoom Event.
Zoom Event Details
Event Date and Time: June 14, 2023, 2:30 PM America/New York
Event Name: Aurania Resources Ltd. Annual and Special Meeting of Shareholders
Aurania shareholders can click this link to register and join the event on June 14th.
Meeting ID: VwX2aCzERRe17va7iquBMg
Proxy Voting Deadline
The Zoom Event is for listening to the proceedings of the Meeting only. To ensure your vote is counted, please cast your vote prior to Monday, June 12th, 2022, at 2:30pm EST as per the details in your form of proxy. Meeting materials can be found on Aurania’s website under the Annual General Meeting tab.
Financial Statements and MD&A (Management’s Discussion & Analysis)
Aurania’s annual financial statements for the year-ended December 31, 2022, and the interim financial statements and MD&A for three months ended March 31, 2022, are available on SEDAR and the Company’s website.
About Aurania
Aurania is a mineral exploration company engaged in the identification, evaluation, acquisition, and exploration of mineral property interests, with a focus on precious metals and copper in South America. Its flagship asset, The Lost Cities – Cutucu Project, is located in the Jurassic Metallogenic Belt in the eastern foothills of the Andes mountain range of southeastern Ecuador.
For further information, please contact:
Carolyn Muir
VP Corporate Development & Investor Relations
Aurania Resources Ltd.
(416) 367-3200
[email protected]Neither the TSX-V nor its Regulation Services Provider (as that term is defined in the policies of the TSX-V) accepts responsibility for the adequacy or accuracy of this release.
FLORHAM PARK, N.J., June 05, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced that the Company will be hosting a conference call and webcast tomorrow, June 6, 2023, to discuss the promising interim data from the VERSATILE-002 (NCT04260126) Phase 2 clinical trial investigating PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), presented at the 2023 American Society for Clinical Oncology (ASCO) meeting.
During the call, management will provide an in-depth review of the 2023 ASCO interim data.
Conference Call Information: PDS Biotech will host a conference call on Tuesday, June 6, at 8:00 a.m. ET to discuss the interim data being presented at the ASCO 2023 Annual Meeting. A live webcast of the event will be available online at PDS Biotech Post-ASCO Webcast. The event will be archived in the investor relations section of PDS Biotech’s website for six months.
Additionally, interested participants and investors may access the conference call by dialing either 877-407-3088 (US) or 201-389-0927 (International).
About PDS Biotechnology PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune®, Versamune® plus PDS0301, and Infectimune™ T cell-activating platforms. We believe our targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the ability to reduce and shrink tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials and will be advancing into a Phase 3 clinical trial in combination with KEYTRUDA® for the treatment of recurrent/metastatic HPV16-positive head and neck cancer in 2023. Our Infectimune™ based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.
Acquisition Increases Schwazze’s New Mexico Retail Store Count to 32 and Provides Expanded Coverage Throughout State
DENVER, June 5, 2023 /CNW/ – Medicine Man Technologies, Inc., operating as Schwazze, (OTCQX: SHWZ) (NEO: SHWZ) (“Schwazze” or the “Company”), announced it has acquired certain assets of Sucellus, LLC, pursuant to which the Company will manage Everest Apothecary, Inc. (“Everest“), a New Mexico not-for-profit corporation. The transaction includes retail dispensaries, cultivation, and manufacturing facilities.
The acquisition of Everest increases the Company’s retail consumer base and furthers Schwazze’s growth strategy in the New Mexico market. Upon closing, Schwazze’s New Mexico operations will include 32 dispensaries, four cultivations, two manufacturing facilities and over 400 employees statewide.
The Everest brand complements Schwazze’s existing retail brand in New Mexico, R. Greenleaf. Each serves a unique demographic, and both retail banners will continue to operate in the state.
“This acquisition fits well within our growing portfolio of retail brands alongside R.Greenleaf, and firmly positions us as a top operator in the New Mexico market,” said Nirup Krishnamurthy, President of Schwazze.
“Collaborating on Schwazze’s operating playbook, we look forward to working with the Everest team members to continue to support the Everest customers with outstanding service and an even wider selection of quality products throughout the entire state. These really are two great teams coming together as one,” said Ken Diehl, New Mexico Division President of Schwazze.
Established in 2016, Everest is a New-Mexico-based licensed medical and recreational cannabis provider that consists of 14 dispensaries, one cultivation facility and one manufacturing plant. The dispensaries are in Albuquerque, Santa Fe, Las Cruces, Los Lunas, Sunland Park, Belen, and Texico. Everest’s cultivation and manufacturing facilities are both located in Albuquerque.
Since April 2020, Schwazze has acquired, opened, or announced the planned acquisition of 60 cannabis retail dispensaries (bannered as Star Buds, Emerald Fields, R. Greenleaf, Standing Akimbo, and Everest) as well as six operating cultivation facilities and three manufacturing plants across Colorado and New Mexico. In May 2021, Schwazze announced its Biosciences division, and in August 2021, it commenced home delivery services in Colorado.
ABOUT SCHWAZZE
Schwazze (OTCQX: SHWZ) (NEO: SHWZ) is building a premier vertically integrated regional cannabis company with assets in Colorado and New Mexico and will continue to take its operating system to other states where it can develop a differentiated regional leadership position. Schwazze is the parent company of a portfolio of leading cannabis businesses and brands spanning seed to sale. The Company is committed to unlocking the full potential of the cannabis plant to improve the human condition.
Schwazze is anchored by a high-performance culture that combines customer-centric thinking and data science to test, measure, and drive decisions and outcomes. The Company’s leadership team has deep expertise in retailing, wholesaling, and building consumer brands at Fortune 500 companies as well as in the cannabis sector. Schwazze is passionate about making a difference in our communities, promoting diversity and inclusion, and doing our part to incorporate climate-conscious best practices.
Medicine Man Technologies, Inc. was Schwazze’s former operating trade name. The corporate entity continues to be named Medicine Man Technologies, Inc. Schwazze derives its name from the pruning technique of a cannabis plant to enhance plant structure and promote healthy growth. To learn more about Schwazze, visit www.Schwazze.com.
Forward-Looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “may,” “will,” “could,” “would,” “should,” “expect,” “intends,” “plans,” “strategy,” “prospects,” “anticipate,” “believe,” “approximately,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing,” or the negative of these terms or other words of similar meaning in connection with a discussion of future events or future operating or financial performance, although the absence of these words does not necessarily mean that a statement is not forward-looking. Forward-looking statements are not guarantees of future events or performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control and cannot be predicted or quantified. Consequently, actual events and results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) regulatory limitations on our products and services and the uncertainty in the application of federal, state, and local laws to our business, and any changes in such laws; (ii) our ability to manufacture our products and product candidates on a commercial scale on our own or in collaboration with third parties; (iii) our ability to identify, consummate, and integrate anticipated acquisitions; (iv) general industry and economic conditions; (v) our ability to access adequate capital upon terms and conditions that are acceptable to us; (vi) our ability to pay interest and principal on outstanding debt when due; (vii) volatility in credit and market conditions; (viii) the loss of one or more key executives or other key employees; and (ix) other risks and uncertainties related to the cannabis market and our business strategy. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements because of new information, future events or otherwise except as required by law.
Inclusion in the Russell Microcap Index reflects significant growth in market cap over the past 12 months
FRISCO, TX / ACCESSWIRE / June 5, 2023 / GameSquare Holdings, Inc. (“GameSquare”, or the “Company”) (NASDAQ:GAME)(TSXV:GAME) announced today that it is set to join the Russell Microcap® Index at the conclusion of the 2023 Russell indexes annual reconstitution, effective after the U.S. market opens on June 26, according to a preliminary list of additions posted June 2.
Justin Kenna, Chief Executive Officer of GameSquare, stated, “Joining the Russell Microcap® Index is an important milestone for GameSquare. Our market cap has increased over 120% over the past 12 months, reflecting the successful execution of our growth strategies and record pipeline, as well as our recent merger with Engine Gaming and Nasdaq listing. We believe our awareness and exposure within the investment community will further increase as a member of the Russell Microcap® Index, and we are excited by the growing momentum underway across our business.”
Membership in the Russell Microcap® Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.
Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $12.1 trillion in assets are benchmarked against Russell’s US indexes. Russell indexes are part of FTSE Russell, a leading global index provider.
For more information on the Russell Microcap® Index and the Russell indexes reconstitution, go to the “Russell Reconstitution” section on the FTSE Russell website.
About GameSquare Holdings, Inc.
GameSquare Holdings, Inc. (NASDAQ:GAME | TSXV:GAME) is a vertically integrated, digital media, entertainment and technology company that connects global brands with gaming and youth culture audiences. GameSquare’s end-to-end platform includes GCN, a digital media company focused on gaming and esports audiences, Cut+Sew (Zoned), a gaming and lifestyle marketing agency, USA, Code Red Esports Ltd., a UK based esports talent agency, Complexity Gaming, a leading esports organization, Fourth Frame Studios, a creative production studio, Mission Supply, a merchandise and consumer products business, Frankly Media, programmatic advertising, Stream Hatchet, live streaming analytics, and Sideqik a social influencer marketing platform. www.gamesquare.com
About FTSE Russell:
FTSE Russell is a global index leader that provides innovative benchmarking, analytics and data solutions for investors worldwide. FTSE Russell calculates thousands of indexes that measure and benchmark markets and asset classes in more than 70 countries, covering 98% of the investable market globally.
FTSE Russell index expertise and products are used extensively by institutional and retail investors globally. Approximately $20.1 trillion is currently benchmarked to FTSE Russell indexes. For over 30 years, leading asset owners, asset managers, ETF providers and investment banks have chosen FTSE Russell indexes to benchmark their investment performance and create ETFs, structured products and index-based derivatives.
A core set of universal principles guides FTSE Russell index design and management: a transparent rules-based methodology is informed by independent committees of leading market participants. FTSE Russell is focused on applying the highest industry standards in index design and governance and embraces the IOSCO Principles. FTSE Russell is also focused on index innovation and customer partnerships as it seeks to enhance the breadth, depth and reach of its offering.
FTSE Russell is wholly owned by London Stock Exchange Group.
This news release contains “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements”) within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking statements and are based on expectations, estimates and projections as at the date of this news release. Any statement that involves discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking statements. In this news release, forward-looking statements relate, among other things, to: the Company’s future performance and revenue; continued growth and profitability; the Company’s ability to execute its business plan; and the proposed use of net proceeds of the Offering. These forward-looking statements are provided only to provide information currently available to us and are not intended to serve as and must not be relied on by any investor as, a guarantee, assurance or definitive statement of fact or probability. Forward-looking statements are necessarily based upon a number of estimates and assumptions which include, but are not limited to: the Company being able to grow its business and being able to execute on its business plan, the Company being able to complete and successfully integrate acquisitions, the Company being able to recognize and capitalize on opportunities and the Company continuing to attract qualified personnel to supports its development requirements. These assumptions, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such factors include, but are not limited to: the Company’s ability to achieve its objectives, the Company successfully executing its growth strategy, the ability of the Company to obtain future financings or complete offerings on acceptable terms, failure to leverage the Company’s portfolio across entertainment and media platforms, dependence on the Company’s key personnel and general business, economic, competitive, political and social uncertainties including impact of the COVID-19 pandemic and any variants. These risk factors are not intended to represent a complete list of the factors that could affect the Company which are discussed in the Company’s most recent MD&A. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on the forward-looking statements and information contained in this news release. GameSquare assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Trial in Progress poster detailed design of Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa
NEWTOWN, Pa., June 05, 2023 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced the presentation of a Trials in Progress poster at the American Society of Clinical Oncology (ASCO) Annual Meeting, which is taking place June 2 – 6, 2023 in Chicago, Illinois and online.
The poster, which was presented on Saturday, June 3, 2023, during the “Melanoma/Skin Cancers” session, detailed the design of an investigator-sponsored Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC). A copy of the poster, titled “A pilot, open study to assess efficacy and safety of ON-01910 (rigosertib) in patients with recessive dystrophic epidermolysis bullosa associated locally advanced/metastatic squamous cell carcinoma,” is available on the “Scientific Presentations” section of the Onconova website.
About RDEB-associated SCC
RDEB is caused by insufficient expression of normal type VII collagen protein, which is responsible for anchoring the skin’s inner layer to its outer layer. This leads to extreme skin fragility as well as chronic blistering and wound formation with recurrent infections in RDEB patients, many of whom go on to develop metastatic squamous cell carcinoma driven by overexpression of polo like kinase 1 (PLK-1). RDEB-associated SCC tumors show a highly aggressive and early metastasizing course that makes them the primary cause of death for these patients, with a cumulative risk of death of 70% and 78.7% by ages 45 and 55, respectively1,2. RDEB-associated SCC can appear in pediatric patients or in young adults. Currently available treatments such as targeted therapies and conventional chemo- and/or radiotherapy have demonstrated limited response rates and poor durability in RDEB-associated SCC1,3.
About Onconova Therapeutics, Inc.
Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.
Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in a combination trial with estrogen blockade in advanced endometrial cancer. Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova is also evaluating opportunities for combination studies with narazaciclib in additional indications.
Onconova’s product candidate rigosertib is being studied in multiple investigator-sponsored studies. These studies include a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer, a Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC), and a Phase 2 trial evaluating rigosertib in combination with pembrolizumab metastatic melanoma.
Fine et al. J Am Acad Dermatol. 2009 Feb; 60(2):203-11. doi: 10.1016/j.jaad.2008.09.035.
Stratigos et al. Eur J Cancer. 2020 Mar;128:83-102. doi: 10.1016/j.ejca.2020.01.008.
Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding its clinical development and trials, its product candidates, its business and financial position. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “preliminary,” “encouraging,” “approximately” or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova’s clinical trials, investigator-initiated trials and regulatory agency and institutional review board approvals of protocols, Onconova’s collaborations, market conditions and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
SAN DIEGO, June 05, 2023 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS), a Technology Company in the Defense, National Security and Global Markets, has been awarded a contract by the Naval Surface Warfare Center Dahlgren Division (NSWCDD) for thermo-mechanical and aerothermal ground testing of thermal protection system materials in ballistic reentry and reentry-like environments in its Kratos SRE business unit in Birmingham, Alabama. The five-year contract includes options with a total value up to $46.7 million, with an initial award of $8.6 million under a cost-plus-fixed-fee contract.
The effort will test materials supporting technical efforts for the U.S. and the U.K. with direct oversight from the NSWCDD Reentry Systems Office. The support includes sample preparation, instrumentation, testing and gathering thermo-mechanical data on materials at extremely high temperatures and in high heat flux/shear environments. The contract enables Kratos SRE to conduct ground testing of thermal protection materials at external ground test facilities and produce flight hardware for the Navy. It requires the unique ability to test and collect data at maximum temperatures of 5,500 degrees Fahrenheit to properly test materials in reentry-like environments.
Michael Johns, Senior Vice President of Kratos SRE, said, “We are honored to support NSWCDD for this important program and are proud that we have been able to do so for decades. We bring a unique capability to this program and through the hard work of our expert team, we look forward to helping our nation as part of the larger Navy team.”
Dave Carter, President of Kratos’ Defense & Rocket Support Services Division, said, “Our division has a long and valued relationship with the Navy supporting research rocket and ballistic missile target programs. The addition of the NSWCDD RSO work by adding KSRE to our division team is exciting, and we look forward to continuing our role as a trusted provider for the Navy.”
Kratos SRE, formerly part of Southern Research and acquired by Kratos in May 2022, is an advanced concept group within Kratos’ Defense & Rocket Support Services (KDRSS) Division. SRE currently employs about 175 engineers, technicians and program support professionals conducting work in support of the space community, the Department of Defense and other national security customers.
About Kratos Defense & Security Solutions Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS) is a Technology Company that develops and fields transformative, affordable systems, products and solutions for United States National Security, our allies and global commercial enterprises. At Kratos, Affordability is a Technology, and Kratos is changing the way breakthrough technology is rapidly brought to market – at a low cost – with actual products, systems and technologies rather than slide decks or renderings. Through proven commercial and venture capital backed approaches, including proactive, internally funded research and streamlined development processes, Kratos is focused on being First to Market with our solutions, well in advance of competition. Kratos is the recognized Technology Disruptor in our core market areas, including Space and Satellite Communications, Cyber Security and Warfare, Unmanned Systems, Rocket and Hypersonic Systems, Next-Generation Jet Engines and Propulsion Systems, Microwave Electronics, C5ISR and Virtual and Augmented Reality Training Systems. For more information, please visit www.KratosDefense.com.
Notice Regarding Forward-Looking Statements Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations, and assumptions of the management of Kratos and are subject to significant risks and uncertainty. Investors are cautioned not to place undue reliance on any such forward-looking statements. All such forward-looking statements speak only as of the date they are made, and Kratos undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise. Although Kratos believes that the expectations reflected in these forward-looking statements are reasonable, these statements involve many risks and uncertainties that may cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Kratos in general, see the risk disclosures in the Annual Report on Form 10-K of Kratos for the year ended December 25, 2022, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Kratos.
Tianeptine’s Mechanism of Restoring Neuroplasticity and Neurogenesis by Dual PPAR-β/δ and PPAR-γAgonismSupports Development as a First-in-Class Oral Therapy for Psychiatric and Neurodegenerative Diseases
Racemic Tianeptine, or TNX-601 ER, is Enrolling in a Potentially Pivotal Phase 2 Study for the Treatment of Major Depressive Disorder; Results from Interim Analysis Expected Fourth Quarter 2023
Single (S)-Isomer of Tianeptine, or TNX-4300, is Free from µ-Opioid Receptor Activity Associated with the (R)-Isomer
TNX-4300 is in Preclinical Development for Depression, Bipolar Disorder, Alzheimer’s Disease and Parkinson’s Disease
CHATHAM, N.J., June 05, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the presentation of data detailing the mechanism of action and pharmacokinetics of TNX-601 ER (tianeptine hemioxalate extended release) and TNX-4300 (estianeptine) at the American Society of Clinical Psychopharmacology (ASCP) meeting in Miami, Fla. TNX-601 ER is being tested in a potentially pivotal Phase 2 trial for the treatment of major depressive disorder (MDD) for which results of a preplanned interim analysis are expected in the fourth quarter of 2023. TNX-4300 is in preclinical development for mood disorders, Alzheimer’s disease and Parkinson’s disease. The active ingredient of both products is the (S)-isomer of tianeptine.1 The (S)-isomer of tianeptine activates PPAR-β/δ, restores neuroplasticity in neuronal tissue culture and lacks µ-opioid liability. In contrast, the (R)-isomer of tianeptine lacks PPAR-β/δ activity and is an agonist at the µ-opioid receptor. The poster presentation is available on Tonix’s website: www.tonixpharma.com.
Tonix recently announced that the plastogen anti-depressant tianeptine, a drug marketed outside the U.S. for more than 30 years, acts on nuclear PPAR-β/δ and PPAR-γ in neurons and glia to restore neuronal connectivity in depression.2 The understanding that tianeptine bypasses the synapse and acts on the nucleus to exert its effects on restoring neuroplasticity and neurogenesis has direct applicability in a number of neurodegenerative diseases in which neuronal connections are atrophying.2 The newly reported mechanism also provides clarity on why tianeptine is not associated with sexual dysfunction, weight gain or several other treatment-limiting toxicities, which are associated with the antidepressants currently marketed in the U.S. for long-term use.
“Restoring atrophied neuronal connections in psychiatric and neurodegenerative diseases has the potential to achieve better and more durable outcomes,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “The tianeptine marketed outside the U.S. for treating depression is a 1:1 racemic mixture of two mirror image isomers. Our team of scientists isolated and characterized the (S)-isomer of tianeptine, which is free from µ-opioid receptor activity and is now under development as TNX-4300 for treating psychiatric and neurodegenerative diseases. The (S)-isomer of tianeptine is responsible for tianeptine’s activity on PPAR-β/δ and restoring neuroplasticity and neurogenesis, while the (R)-isomer is responsible for any off-target activity on the µ-opioid receptor.”
The findings reported at the meeting show how the pharmacokinetics of oral TNX-601 ER in humans differ from intraperitoneal (i.p.) tianeptine in mice. In humans, after an oral dose of TNX-601 ER the half-life of tianeptine in the blood is approximately 5-7 hours. In contrast, in mice after an i.p. dose of tianeptine the half-life of tianeptine in the blood has been reported to be less than approximately 30 minutes and the behavioral effects appear dominated by the longer-lasting MC5 metabolite, which maintains µ-opioid receptor activity.3 The data Tonix presented also show that the (R)-isomer of tianeptine is responsible for the decrease in immobility in the mouse forced swim test after i.p. administration, which is consistent with previous reports that the effect of tianeptine on the forced swim test is a µ-opioid receptor-dependent phenomenon.3
Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals, said, “From our clinical studies on volunteers, after oral dosing with TNX-601 ER, the extended pharmacokinetics of parent tianeptine is consistent with tianeptine exerting activity on PPAR-β/δ and resulting in neurorestorative effects. In contrast, after i.p. dosing of tianeptine in mice, the exposure of tianeptine is brief and the behavioral effects appear dominated by the MC5 metabolite.3 While tianeptine’s MC5 metabolite has been reported to maintain µ-opioid receptor activity3, we found that MC5 metabolite lacks activity on either PPAR-β/δ or PPAR-γ in culture. Together, we believe these findings support the interpretation that the parent tianeptine and specifically, the (S)-isomer of tianeptine exert antidepressant effects in humans by interacting with PPAR-β/δ and PPAR-γ.”
Dr. Sullivan continued, “Our ongoing work on racemic tianeptine in depression is expected to inform and potentially accelerate the development of TNX-4300. The dose of tianeptine for treating depression is well-established from racemic studies, so we plan to test single isomer TNX-4300 at a dose equivalent to 50% of the racemic dose, which is expected to provide equivalent exposure of (S)-tianeptine as racemic tianeptine. Subsequently, we plan to test higher doses of (S)-tianeptine, because TNX-4300 lacks µ-opioid receptor activity, but such studies will require additional non-clinical studies.”
Key experiments were performed by scientists at Tonix’s Research and Development Center (RDC) in Frederick, Maryland.
Racemic tianeptine sodium (amorphous) immediate release (dosed 3 times daily) was first marketed for depression in France in 1989 and has been available for decades in Europe, Russia, Asia, and Latin America for the treatment of depression. Tianeptine sodium has an established safety profile from decades of use in these jurisdictions. Currently no tianeptine-containing product is approved in the U.S. and no extended-release tianeptine product is approved in any jurisdiction. In animal models, tianeptine restores dendritic arborization of pyramidal neurons in the CA3 region of hippocampus and in the dentate gyrus region promotes new neuron formation and integration into hippocampal networks.1 Tianeptine’s enhancement of neuroplasticity in animal models of stress is believed to be mediated by activation of PPAR isoforms PPAR-β/δ and PPAR-γ, which makes its properties distinct from traditional monoaminergic antidepressants in the U.S. and contributes to its potential for clinical indications beyond MDD and stress disorders. Tianeptine and its MC5 metabolite are also weak mu-opioid receptor (MOR) agonists that present a potential abuse liability if illicitly misused in large quantities (typically abused at 8-80 times the therapeutic dose on a daily basis).2 In patients who were prescribed tianeptine for depression, the French Transparency Committee found an incidence of misuse of approximately 1 case per 1,000 patients treated3 suggesting low abuse liability when used at the antidepressant dose in patients prescribed tianeptine for depression. Clinical trials have shown that cessation of a therapeutic course of tianeptine does not appear to result in dependence or withdrawal symptoms following 6-weeks4-8, 3-months9, or 12-months10 of treatment. (S)-tianeptine mimics naturally occurring polyunsaturated fatty acid ligands in binding PPAR-β/δ and PPAR-γ. (S)-tianeptine’s activation of nuclear PPAR-β/δ and PPAR-γ receptors appears to be a more direct mechanism to achieve the goal of restoring neuronal connectivity than current therapies. Its proposed mechanism as a plastogen is consistent with its clinical effects in promoting cognition in Alzheimer’s disease and bipolar disorder11,12 in addition to posttraumatic stress disorder (PTSD) and corticosteroid-induced cognitive dysfunction. The PPAR-β/δ target is validated by prior work on agonists treating animal models of neurodegenerative and autoimmune diseases of the central nervous system13 and the concept that Alzheimer’s can be considered a form of diabetes that affects the CNS, or type-III diabetes.”14 Tianeptine’s reported pro-cognitive and anxiolytic effects as well as its ability to attenuate the neuropathological effects of excessive stress responses suggest that it may also be used to treat posttraumatic stress disorder (PTSD), and neurocognitive dysfunction associated with corticosteroid use.
1 McEwen, B. S., et al. Mol. Psychiatry 2010, 15 (3), 237–249. 2 Lauhan, R., et al. Psychosomatics 2018, 59 (6), 547–53. 3 Haute Authorite de Sante; Transparency Committee Opinion. Stablon 12.5 Mg, Coated Tablet, Re- Assessment of Actual Benefit at the Request of the Transparency Committee. December 5, 2012. 4 Emsley, R., et al. J. Clin. Psychiatry 2018, 79 (4) 5 Bonierbale M, et al. Curr Med Res Opin 2003, 19(2):114-124. 6 Guelfi, J. D., et al. Neuropsychobiology 1989, 22 (1), 41–48. 7 Invernizzi, G. et al., Neuropsychobiology 1994, 30 (2–3), 85–93. 8 Lepine, J. P., et al. Hum. Psychopharmacol. 2001, 16 (3), 219–227. 9 Guelfi, J. D. et al., Neuropsychobiology 1992, 25 (3), 140–148. 10 Lôo, H. et al., Br. J. Psychiatry. Suppl. 1992, 15, 61–65. 11 García-Alberca JM, et al. J Alzheimer’sDis 2022, 88 (2), 707-720. 12 Kauer-Sant’Anna M, et al. J Psychopharmacol 2019, 33 (4), 502-510. 13 Kahremany S et al. Br J Pharmacol 2015, 172(3):754-70 14 Nguyen et al., Int J Mol Sci. 2010, 21(9):3165
Tonix Pharmaceuticals Holding Corp.*
Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with topline data expected in the fourth quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 study has been completed, and topline results are expected in the third quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), in development for chronic migraine, is currently enrolling with topline data expected in the fourth quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets), a once-daily formulation being developed as a treatment for major depressive disorder (MDD), is also currently enrolling with interim data expected in the fourth quarter of 2023. TNX-4300 (estianeptine) is a small molecule oral therapeutic in preclinical development to treat MDD, Alzheimer’s disease and Parkinson’s disease. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the third quarter of 2023. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox, for which a Phase 1 study is expected to be initiated in the second half of 2023. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. The infectious disease portfolio also includes TNX-3900 and TNX-4000, classes of broad-spectrum small molecule oral antivirals.
*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.
This press release and further information about Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
MALVERN, Pa., June 05, 2023 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that the Company has established a Business Advisory Board to assist in driving public/private partnerships with governments around the world; pursuing business collaborations, partnerships, and licensing opportunities; creating awareness of the Company’s differentiated capabilities; and promoting access to the Company’s therapies around the world.
“I am delighted to welcome this notable group of advisors to Ocugen,” said Dr. Shankar Musunuri, Chairman, CEO and Co-founder of Ocugen. “At this stage in the Company’s growth, it is critical to foster collaborations—among industry and with government agencies—to continue driving our clinical programs and maximizing value for our shareholders and patients. The Business Advisory Board will provide new insight to our business strategy, while expanding our reach to execute the strategy.”
Ocugen’s Business Advisory Board members have been selected based on their extensive professional backgrounds and proven track record of creating partnerships among the public and private sector. Members include:
Ambassador Joseph W. Westphal, PhD, Global Senior Fellow at the Joseph H. Lauder Institute of Management and International Studies at The Wharton School of The University of Pennsylvania. Dr. Westphal was the U.S. Ambassador to the Kingdom of Saudi Arabia from March 2014 to January 2017. He also held the positions of Assistant Secretary of the Army (Head of the Army Corps of Engineers) from 1998 to 2000 and Acting Secretary of the Army in 2001.
Pat Toomey, U.S. Senator who represented Pennsylvania from 2011 to 2023. As a senior member of the Senate Finance Committee, Senator Toomey helped to develop and pass the 2017 tax reform—the most sweeping reform in over 30 years. He previously served in the U.S. House of Representatives from 1999-2005. In addition to his public service, the senator has also worked in the financial services industry, trading and managing a portfolio of fixed income derivatives first for Chemical Bank and later for Morgan Grenfell.
Dennis Carey, PhD, Vice Chairman of Korn Ferry, where he recruits Board Directors, CEOs, and their direct reports. He has placed and assessed some of the most successful CEOs and directors for over 75 leading companies in the Fortune 500. Dr. Carey founded several forums for Chairmen, CEOs, and C-Suite executives. He has published seven books, his three most recent being, Talent Strategy Risk, Boards that Lead, and Talent Wins. In addition to his books, he has published over 50 refereed journal articles. Dr. Carey also teaches Corporate Governance at The Wharton School of The University of Pennsylvania.
“As the world faces critical challenges to public health from viruses and diseases, the research and development by Ocugen through cell and gene therapies and vaccines is an important effort to address these growing and impactful contributions to world health,” said Ambassador Westphal.
“I look forward to helping advance Ocugen—a leading Pennsylvania Biotech,” said Senator Toomey. “I will always be committed to driving economic growth in the state and this role is an extension of my many years in public office.”
“I’ve watched Ocugen evolve over the last few years as a business consultant and am now honored to join the Business Advisory Board,” said Dr. Carey. “Now is the right time to bring this group together, as there are several transformative milestones ahead in the near term.”
The Business Advisory Board will work alongside the Executive Leadership Team to offer guidance, perspective, and insight to enable the Company to fulfill its mission and achieve its short- and long-term strategy.
About Ocugen, Inc. Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.
Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.
Contact: Tiffany Hamilton Head of Corporate Communications [email protected]