Company Has Launched New ‘Lived Experience’ Reentry Programs in Past Year
BRENTWOOD, Tenn., April 17, 2023 (GLOBE NEWSWIRE) — CoreCivic, Inc. (NYSE: CXW) (the Company) today released its 2022 Environmental, Social and Governance (ESG) report. The Company’s fifth annual report illustrates CoreCivic’s longstanding commitment to operating safely, ethically and transparently while making a positive impact on the communities it serves together with government partners.
“CoreCivic’s durability over the last 40 years reveals our character, and that shows in our progress toward our ESG goals,” said Damon Hininger, president and CEO, CoreCivic. “I’m proud of the way our first-class staff have continually innovated over the years, and especially in 2022, to serve our government partners dependably, compassionately and with excellence.”
The 2022 report details CoreCivic’s commitments and progress toward goals in safe and secure operations; reentry services; innovative solutions delivery; health services; talent attraction; diversity, equity and inclusion (DE&I); and more.
The Company’s approach to reentry services has grown to include several new programs and others in the pipeline that involve residents learning from the “lived experience” of others who have been incarcerated. CoreCivic staff and leaders are rising to meet the threat posed by dangerous contraband such as opioids. The Company has invested in mental health resources to help keep residents safe and delivered human rights training to 97 percent of continuing employees. By diversifying its supply chain, CoreCivic has created more opportunities than ever for women-and minority-owned businesses to partner with the Company. Wages were also increased for nearly all facility staff not already covered by the wage determination process in federal contracts.
CoreCivic also realigned its internal structure in 2022, combining real estate operations with community corrections operations and naming Executive Vice President Lucibeth Mayberry as Chief Innovation Officer.
Mayberry’s team is already making positive impacts on the wellbeing of residents and staff. For example, thanks to the innovation team, CoreCivic offered alternative housing options for staff to combat the national housing shortage in the U.S. The team helped create a normalization process for easing residents out of a correctional environment by transitioning to more home-like surroundings. And it launched a collaboration with government partners to provide free tablets to residents to promote easier contact with family and loved ones, an essential component of successful reentry.
GI Jobs has recognized CoreCivic as a Military Friendly Employer for the 12th consecutive year, conferring Gold Status on the Company. CoreCivic also received a 30 percent year-over-year increase in employment applications. And it connected more than 600 community volunteers with facility residents and staff to help facilitate successful reentry through partnerships like the Frederick Douglass Project for Justice, the Maverick City Music Initiative and second chance hiring firm Cornbread Hustle.
The Company also advocated for recidivism-reducing policies in nine states, including a successful South Carolina state tax credit for hiring formerly incarcerated individuals. Since launching this public policy initiative in 2017, CoreCivic has sent 2,883 letters to federal and state officials in support of 113 reentry-friendly bills with 20 pieces of legislation signed into law.
“There’s a lot to be proud of in the work CoreCivic did in 2022 and over the last 40 years,” Hininger said. “We’ve succeeded, and expect to keep succeeding, because we’re willing to learn from each other, from our residents, and from the agencies, groups, and institutions who serve as our partners.”
About CoreCivic CoreCivic is a diversified, government-solutions company with the scale and experience needed to solve tough government challenges in flexible, cost-effective ways. We provide a broad range of solutions to government partners that serve the public good through high-quality corrections and detention management, a network of residential and non-residential alternatives to incarceration to help address America’s recidivism crisis, and government real estate solutions. We are the nation’s largest owner of partnership correctional, detention and residential reentry facilities, and believe we are the largest private owner of real estate used by U.S. government agencies. We have been a flexible and dependable partner for government for more than 40 years. Our employees are driven by a deep sense of service, high standards or professionalism and a responsibility to help government better the public good. Learn more at www.corecivic.com.
Research Directed by Faculty of the Center for Transplantation Sciences, Massachusetts General Hospital
CHATHAM, N.J., April 17, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced the on-line publication of two papers1,2 in the American Journal of Transplantation by faculty at the Center for Transplantation Sciences, Massachusetts General Hospital (MGH) in collaboration with Tonix Pharmaceuticals. The data involve studies of Tonix’s TNX-1500 (Fc-modified anti-CD40L humanized monoclonal antibody [mAb]) product candidate 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, T-BAM or 5c8 antigen. The publications 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 and safely prevented pathologic alloimmunity in non-human primate models of cardiac and kidney allograft model without clinical thrombosis.
“There remains a significant need for new treatments with improved activity and tolerability to prevent organ transplant rejection,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “To date, there has not been a humanized anti-CD40L antibody that can effectively prevent transplant rejections with an acceptable level of tolerability. 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. The animal studies found that TNX-1500 retains activity to prevent rejection and preserve graft function. Tonix expects to start a first-in-human Phase 1 study in the second quarter of 2023 of TNX-1500 for prophylaxis of organ rejection in adult patients receiving a kidney transplant.”
Tatsuo Kawai, M.D., Ph.D., A. Benedict Cosimi Chair in Transplant Surgery, MGH and Professor of Surgery, Harvard Medical School (HMS) and senior author of the kidney transplant publication, said, “The blockade of the CD40L-CD40 pathway with anti-CD40L mAbs has been the most promising immunomodulatory approach to prevent allograft rejection. However, long-term graft and patient survival following transplantation of kidneys and other solid organs are constrained by side effects of the existing medications. Our data demonstrate a favorable safety profile associated with TNX-1500, since neither non-human primate nor human platelet activation were observed in-vitro when exposed to TNX-1500-sCD40L immune complexes. The therapeutic effects of TNX-1500 to consistently inhibit rejection of mismatched kidney allografts were not associated with infectious or thromboembolic complications, suggesting that clinical studies are warranted to evaluate TNX-1500 for transplant indications.”
Richard N. Pierson III, M.D., scientific director of the Center for Transplantation Sciences in the Department of Surgery at MGH and Professor of Surgery at HMS and senior author of the heart transplant paper said, “Anti-CD40L therapy has a unique activity in controlling the immune response to organ transplants. There remains a significant need for new treatments with improved activity and tolerability to prevent or treat organ transplant rejection. Anti-CD40L has shown great promise to facilitate transplant tolerance in multiple preclinical transplant models. A safe, effective anti-CD40L also has potential to enable use of genetically modified or humanized pig organs to treat humans with advanced organ failure or diabetes, an emerging field known as xenotransplantation.”
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), a small molecule 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 of tianeptine 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-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 second 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 and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second 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, a class of broad-spectrum small molecule oral antivirals.
*All of Tonix’s product candidates are investigational new drugs or biologics and none has been approved for any indication.
1Lassiter, G., et al. (2023). TNX-1500, a crystallizable fragment–modified anti-CD154 antibody, prolongs nonhuman primate renal allograft survival. American Journal of Transplantation. April 3, 2023. https://doi.org/10.1016/j.ajt.2023.03.022
2Miura, S., et al. (2023) TNX-1500, a crystallizable fragment–modified anti-CD154 antibody, prolongs nonhuman primate cardiac allograft survival. American Journal of Transplantation. April 6, 2023. https://doi.org/10.1016/j.ajt.2023.03.025
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.
Conference Call to be held Tuesday, May 9 at 8:00 a.m. Central Time
HOUSTON, April 17, 2023 (GLOBE NEWSWIRE) — Orion Group Holdings, Inc. (NYSE: ORN) (the “Company”), a leading specialty construction company, today announced that it will issue its financial results for the first quarter ended March 31, 2023 on Monday, May 8, 2023, after the close of the stock market.
A conference call and audio webcast with analysts and investors will be held the next day, May 9, at 8:00 a.m. Central Time to discuss the results and answer questions.
Orion Group Holdings, Inc., a leading specialty construction company serving the infrastructure, industrial and building sectors, provides services both on and off the water in the continental United States, Alaska, Canada and the Caribbean Basin through its marine segment and its concrete segment. The Company’s marine segment provides construction and dredging services relating to marine transportation facility construction, marine pipeline construction, marine environmental structures, dredging of waterways, channels and ports, environmental dredging, design, and specialty services. Its concrete segment provides turnkey concrete construction services including place and finish, site prep, layout, forming, and rebar placement for large commercial, structural and other associated business areas. The Company is headquartered in Houston, Texas with regional offices throughout its operating areas.
Contacts:
Financial Profiles, Inc. Margaret Boyce 310-622-8247 [email protected]
SAN DIEGO, April 13, 2023 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (Nasdaq: KTOS), a leading National Security Solutions provider, announced today that it was awarded a contract by a DoD Prime contractor to provide a concurrency upgrade to multiple ground tactical platform maintenance training systems.
Commenting on the award, Jose Diaz, Sr. Vice President at Kratos Training Solutions, stated: “Over the last 25 years Kratos has supported DoD and allied military customers by designing, developing and delivering advanced maintenance training systems. We are committed to delivering the same high level of quality with these upgrades.”
Due to customer, competitive, security-related and other considerations, no additional information will be provided related to this contract award.
Kratos develops advanced, cost-effective maintenance and operational training solutions for U.S. and allied forces to enhance warfighter readiness and survivability. Kratos is driving innovation in military simulation and training programs through application of immersive technologies within advanced simulation systems for air, ground, maritime and space domains.
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, 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.
Streamlining Phase 3 Fibromyalgia and Phase 2 Chronic Migraine Trials by Eliminating Interim Analyses
Topline Results Expected for Both Programs in Fourth Quarter 2023
CHATHAM, N.J., April 13, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced that it is eliminating the interim analyses in its registration-enabling, confirmatory Phase 3 RESILIENT study of TNX-102 SL for fibromyalgia and its Phase 2 PREVENTION study of TNX-1900 for chronic migraine. The modifications to the RESILIENT and PREVENTION studies are designed to streamline the trials and to provide topline data for both programs in 2023. Target enrollment for the core TNX-102 SL fibromyalgia study remains approximately 470 participants while target enrollment for the TNX-1900 chronic migraine study will be reduced from approximately 300 participants to approximately 150 participants, to accommodate the new topline timing.
“In an effort to expedite and deliver on clinical timelines, we are modifying the designs of our confirmatory, registration-enabling Phase 3 trial in fibromyalgia and our Phase 2 trial in chronic migraine,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “By eliminating the interim analyses, we remove the statistical penalties associated with this type of analysis, conserve resources, and can plan on topline results for each of these studies in the fourth quarter of 2023. Fibromyalgia and migraine each affect millions of people, and we remain committed to aligning our operational and scientific efforts on these core CNS programs. We are excited to progress these programs closer to FDA approval, upon achieving positive topline data.”
Key Anticipated 2023 Milestones
Updated Guidance
Eliminating interim analysis of Phase 3 RESILIENT study of TNX-102 SL (sublingual cyclobenzaprine tablets) for fibromyalgia.
Eliminating interim analysis of Phase 2 PREVENTION study of TNX-1900 (intranasal potentiated oxytocin) for chronic migraine; topline results now expected in the fourth quarter of 2023.
Unchanged Guidance
Topline results of Phase 3 RESILIENT study of TNX-102 SL (sublingual cyclobenzaprine tablets) for fibromyalgia in the fourth quarter of 2023.
Topline results of Phase 2 PREVAIL study of TNX-102 SL for fibromyalgia-type Long COVID in the third quarter of 2023.
Interim analysis results of Phase 2 UPLIFT study of TNX-601 ER (tianeptine hemioxalate extended-release tablets) for major depressive disorder in the fourth quarter of 2023.
Initiate enrollment in a potentially pivotal Phase 2 study of TNX-1300 (recombinant double-mutant cocaine esterase for injection) for the treatment of cocaine intoxication in the second quarter of 2023.
Initiate enrollment in a Phase 1 study of TNX-1500 (anti-CD40L monoclonal antibody) for the prophylaxis of rejection in kidney transplantation in the second quarter of 2023.
Initiate enrollment in a Phase 1 study of TNX-801 (live virus vaccine for percutaneous administration), a potential vaccine to protect against smallpox and mpox (formerly known as monkeypox), in the second half of 2023.
Continue development of TNX-2900 (intranasal potentiated oxytocin), a small peptide for the treatment of hyperphagia in Prader-Willi syndrome (PWS), for which the FDA has granted Orphan Drug designation.
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-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 second 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 and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second 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 (IND) or biologics and have not been approved for any indication. TNX-801, TNX-1500, TNX-2900, TNX-3900 and TNX-4000 are in pre-IND stage of development and have not been approved for any indication.
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.
MELVILLE, N.Y. – April 12, 2023– Comtech (NASDAQ: CMTL) today announced the appointment of technology and aerospace industry veteran Donald Walther as the company’s new Chief Legal Officer (CLO).
As a trusted advisor, Walther brings nearly three decades of legal expertise to his position as Comtech’s CLO. Walther’s experience spans both private and public companies in the commercial and defense sectors that are well aligned with Comtech’s future growth trajectories in U.S. and International markets. In his most recent position, Walther served as CLO and Corporate Secretary at Robotic Research, a global leader in autonomous driving technology. Previously, Walther served as General Counsel for API Technologies Corp., TopBuildCorp., and Esterline Corporation where he led global organizations like Comtech through transformational change. Earlier, Walther held executive positions at The Heico Companies LLC, ITT Corporation, and The Boeing Company, where he was engaged in the commercial and defense businesses.
“Our One Comtech transformation is working-enabling us to expand into new markets; up-tier our systems, solutions, and services; and introduce new as-a-service business models,” said Ken Peterman, President and CEO, Comtech. “As Comtech continues to scale globally, we are expanding our leadership bench with some of the best and brightest in the industry to create more comprehensive value for our customers and make a lasting, positive impact in the world. As a trusted advisor known across global technology and aerospace markets, Don brings the deep expertise and skillset needed to position Comtech for the future.”
In his position as CLO, Walther will oversee the development and execution of corporate legal strategy, trade compliance, export control, security, contracts, and global leadership growth trajectories across U.S. and international markets. With Walther’s appointment as CLO, Yelena Simonyuk will continue supporting Comtech in a variety of legal matters while focusing her efforts and leadership in matters related to Security and Exchange Commission and other regulatory compliance and expanding her robust role in support of the Comtech Board of Directors as General Counsel.
“Comtech’s technology leadership and unique culture of innovation offer a truly unique opportunity to help connect the unconnected and empower individuals around the world,” said Walther. “I am thrilled to join this talented team as Comtech delivers on the customer-centric vision shared by its employees, shareholders, partners, and customers.”
Walther graduated from Duke University and earned a JD and MBA from the University of Chicago. He is the recipient of multiple industry and leadership awards and is a Six Sigma Green Belt with extensive experience in Strategic Goal Deployment.
About Comtech
Comtech Telecommunications Corp. is a leading global technology company providing terrestrial and wireless network solutions, next-generation 9-1-1 emergency services, satellite and space communications technologies, and cloud native capabilities to commercial and government customers around the world. Our unique culture of innovation and employee empowerment unleashes a relentless passion for customer success. With multiple facilities located in technology corridors throughout the United States and around the world, Comtech leverages our global presence, technology leadership, and decades of experience to create the world’s most innovative communications solutions.For more information, please visit www.comtech.com.
Forward-Looking Statements
Certain information in this press release contains statements that are forward-looking in nature and involve certain significant risks and uncertainties. Actual results and performance could differ materially from such forward-looking information. The Company’s Securities and Exchange Commission filings identify many such risks and uncertainties. Any forward-looking information in this press release is qualified in its entirety by the risks and uncertainties described in such Securities and Exchange Commission filings.
VANCOUVER, BC, April 12, 2023 /CNW/ – Defense Metals Corp. (“Defense Metals” or the “Company“) (TSXV: DEFN) (OTCQB: DFMTF) (FSE: 35D) is pleased to announce that the Phase I of its hydrometallurgical pilot plant at SGS Lakefield has been successfully completed.
John Goode, Consulting Metallurgist to Defense Metals and who attended the pilot plant, commented:
“This first fully integrated pilot plant demonstration of the proposed Wicheeda hydrometallurgical process delivered exactly what was required of it. We have confirmed the general workability of the process, optimized certain design parameters, and identified areas that will be improved ahead of the Phase II pilot plant. The SGS Lakefield team did an excellent job of construction and operation of the circuit, and their efforts are much appreciated.”
The main objective of Phase I of the pilot plant was to test the flowsheet for operability and identify any changes that might be required before a longer test campaign. During the five days of continuous operation, the parameters for the various unit operations were varied slightly to allow optimization of the circuit ahead of the Phase II pilot plant run scheduled for late-April 2023.
Assays are still being received and evaluation of the results has not yet been finalized. However, to date it can be reported that the extraction of Pr (praseodymium) and Nd (neodymium) from the acid bake calcine was in excess of 90%, the impurity removal circuits were very efficient, and reagent regeneration and water recirculation were effective. Minor changes will be made to the circuit ahead of Phase II and an alternative product precipitant will be used.
Methodology
The fully integrated Pilot Plant included sulphuric acid baking, water leaching, three stages of impurity removal, rare earth precipitation, magnesia regeneration and recycling, and process water recycle. The plant ran continuously and without interruption for 24 h/day over a total run time of 110 hours. Operations were handled by a total of ten SGS technicians and metallurgists on each of two shifts managed by senior day-shift staff.
Qualified Person
The scientific and technical information contained in this news release, as it relates to the metallurgical aspects of the Wicheeda Rare-Earth Project, has been reviewed and approved by John Goode, P. Eng., who is a Qualified Person as defined by National Instrument 43-101 and who has provided the technical information relating to metallurgy in this news release.
About the Wicheeda REE Property
Defense Metals 100% owned, 4,262-hectare (~10,532-acre) Wicheeda Light REE property is located approximately 80 km northeast of the city of Prince George, British Columbia; population 77,000. The Wicheeda REE Project is readily accessible by all-weather gravel roads and is near infrastructure, including hydro power transmission lines and gas pipelines. The nearby Canadian National Railway and major highways allow easy access to the port facilities at Prince Rupert, the closest major North American port to Asia.
The 2021 Wicheeda REE Project Preliminary Economic Assessment technical report (“PEA”) outlined a robust after-tax net present value (NPV@8%) of $517 million and an 18% IRR1. This PEA contemplated an open pit mining operation with a 1.75:1 (waste:mill feed) strip ratio providing a 1.8 Mtpa (“million tonnes per year”) mill throughput producing an average of 25,423 tonnes REO annually over a 16 year mine life. A Phase 1 initial pit strip ratio of 0.63:1 (waste:mill feed) would yield rapid access to higher grade surface mineralization in year 1 and payback of $440 million initial capital within 5 years.
About Defense Metals Corp.
Defense Metals Corp. is a mineral exploration and development company focused on the acquisition, exploration and development of mineral deposits containing metals and elements commonly used in the electric power markets, defense industry, national security sector and in the production of green energy technologies, such as, rare earths magnets used in wind turbines and in permanent magnet motors for electric vehicles. Defense Metals owns 100% of the Wicheeda Light Rare Earth Element Deposit located near Prince George, British Columbia, Canada. Defense Metals Corp. trades in Canada under the symbol “DEFN” on the TSX Venture Exchange, in the United States, under “DFMTF” on the OTCQB and in Germany on the Frankfurt Exchange under “35D”.
Defense Metals is a proud member of Discovery Group. For more information please visit: http://www.discoverygroup.ca/
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 news release.
Cautionary Statement Regarding “Forward-Looking” Information
This news release contains “forward–looking information or statements” within the meaning of applicable securities laws, which may include, without limitation, statements relating to advancing the Wicheeda REE Project, the expected benefits and outcomes of the hydrometallurgical pilot plant, the expected completion of the hydrometallurgical pilot plant and the expected timelines, the technical, financial and business prospects of the Company, its project and other matters. All statements in this news release, other than statements of historical facts, that address events or developments that the Company expects to occur, are forward-looking statements. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in the forward-looking statements. Such statements and information are based on numerous assumptions regarding present and future business strategies and the environment in which the Company will operate in the future, including the price of rare earth elements, the anticipated costs and expenditures, the ability to achieve its goals, that general business and economic conditions will not change in a material adverse manner, that financing will be available if and when needed and on reasonable terms. Such forward-looking information reflects the Company’s views with respect to future events and is subject to risks, uncertainties and assumptions, including the risks and uncertainties relating to the interpretation of exploration and metallurgical results, risks related to the inherent uncertainty of exploration and development and cost estimates, the potential for unexpected costs and expenses and those other risks filed under the Company’s profile on SEDAR at www.sedar.com. While such estimates and assumptions are considered reasonable by the management of the Company, they are inherently subject to significant business, economic, competitive and regulatory uncertainties and risks. Factors that could cause actual results to differ materially from those in forward looking statements include, but are not limited to, continued availability of capital and financing and general economic, market or business conditions, adverse weather and climate conditions, failure to maintain or obtain all necessary government permits, approvals and authorizations, failure to maintain community acceptance (including First Nations), risks relating to unanticipated operational difficulties (including failure of equipment or processes to operate in accordance with specifications or expectations, cost escalation, unavailability of personnel, materials and equipment, government action or delays in the receipt of government approvals, industrial disturbances or other job action, and unanticipated events related to health, safety and environmental matters), risks relating to inaccurate geological, metallurgical and engineering assumptions, decrease in the price of rare earth elements, the impact of Covid-19 or other viruses and diseases on the Company’s ability to operate, an inability to predict and counteract the effects of COVID-19 on the business of the Company, including but not limited to, the effects of COVID-19 on the price of commodities, capital market conditions, restriction on labour and international travel and supply chains, loss of key employees, consultants, or directors, increase in costs, delayed results, litigation, and failure of counterparties to perform their contractual obligations. The Company does not undertake to update forward–looking statements or forward–looking information, except as required by law.
____________________________
1 Independent Preliminary Economic Assessment for the Wicheeda Rare Earth Element Project, British Columbia, Canada, dated January 6, 2022, with an effective date of November 7, 2021, and prepared by SRK Consulting (Canada) Inc. is filed under Defense Metals Corp.’s Issuer Profile on SEDAR (www.sedar.com).
FLORHAM PARK, N.J., April 12, 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, announced it will host a Key Opinion Leader (KOL) Roundtable on Interleukin-12 (IL-12) for analysts, investors and the scientific community from 8:00 to 9:00 AM, ET on April 21, 2023.
This PDS Biotech-sponsored event will focus on the potential of an IL-12 immunocytokine in oncology and the clinical results and promise demonstrated to date with PDS0301, the company’s novel investigational tumor-targeting IL-12 fusion protein. The novel investigational antibody targeted IL-12 enhances the proliferation, potency and longevity of T cells in the tumor microenvironment while also limiting its presence in the blood, which appears to promote tolerability and safety. The event will be moderated by PDS Biotech’s Chief Medical Officer, Dr. Lauren Wood, and will feature presentations from the following cancer research experts:
James Gulley, M.D., Ph.D., Co-Director of the Center for Immuno-Oncology, Deputy Director of the Center for Cancer Research, and Acting Clinical Director of the National Cancer Institute
Jeffrey Schlom, Ph.D., Co-Director of the Center for Immuno-Oncology at the Center for Cancer Research of the National Cancer Institute
Registration for PDS Biotech’s IL-12 Focused KOL Roundtable is now open, and a live webcast of the event will be available online in the investor relations section of the company’s website at PDS Biotech – Investor Relations. A replay will be available on the company website for 90 days following the webcast.
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 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.
About PDS0301
PDS0301 is a novel investigational fusion protein of a tumor-targeting antibody and Interleukin 12 (IL-12) that enhances the proliferation, potency and longevity of T cells in the tumor microenvironment. Together with Versamune® based immunotherapies PDS0301 may work synergistically to promote a targeted T cell attack against cancers. PDS0301 is given by a simple subcutaneous injection. Clinical data suggest the addition of PDS0301 to Versamune® based immunotherapies, such as PDS0101, can demonstrate significant disease control by shrinking tumors and/or prolonging survival in patients with recurrent/metastatic cancers with poor survival prognosis.
Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune® and Infectimune™ based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune® and Infectimune™ based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; to aid in the development of the Versamune® platform; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual, quarterly and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.
Versamune® is a registered trademark and Infectimune™ is a trademark of PDS Biotechnology.
COMPANY TO SHARE PRELIMINARY SAFETY AND EFFICACY DATA FROM ONGOING PHASE 1/2 TRIAL OF OCU400 FOR THE TREATMENT OF RETINITIS PIGMENTOSA AND LEBER CONGENITAL AMAUROSIS
MALVERN, Pa., April 11, 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 it will host an Investor and Analyst Event on April 14, 2023, at 8 a.m. ET. During the webcast and conference call, members of the Ocugen leadership team and key opinion leaders will review preliminary safety and efficacy results from the Phase 1/2 trial of OCU400 for the treatment of retinitis pigmentosa (RP) and Leber congenital amaurosis (LCA).
The event will feature:
Shankar Musunuri, PhD, MBA, Chairman, CEO and Co-founder, Ocugen
Arun Upadhyay, PhD, Chief Scientific Officer, Head of Research, Development & Medical, Ocugen
Huma Qamar, MD, MPH, Head of Clinical Development and Medical Affairs, Ocugen
David Birch, PhD, Scientific Director, Retina Foundation of the Southwest, primary investigator of the study
Neena B. Haider, PhD, Fellow of ARVO and inventor of modifier gene therapy
Webcast and Conference Call Details
Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers Conference ID: 4898155 Webcast: Available on the events section of the Ocugen investor site
A replay of the call and archived webcast will be available for approximately 45 days following the event on the Ocugen investor site.
About Ocugen, Inc. Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies 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.
VIRGINIA CITY, NEVADA,April 11, 2023 – Comstock Inc. (NYSE: LODE) (“Comstock” and the “Company”) today announced the board of directors of Comstock Inc. nominated and appointed Dr. Güez Salinas, as a new independent director to the Company’s Board of Directors and appointed Mr. Walter “Del” Marting as the Chairman of the Company’s Audit and Finance Committee. The Company also announced the resignation of Mr. Judd Merrill as a director of the company, all effective as of April 5, 2023.
Dr. Salinas has over 30 years of professional experience in the areas of engineering, strategy, finance, corporate management, and business development, with a primary focus on cyber-security and artificial intelligence policy and is currently an international cyber security expert at the Pacific Council on International Policy. Dr. Salinas has also been advising Quantum Generative Materials LLC (“GenMat”) on strategy and commercialization.
Dr. Salinas also founded and serves as the Director Emeritus of The Polymathic Academy for the Teaching of the Humanities & Sciences (“The PATH”) where he mentors and develops students’ multidisciplinary entrepreneurial pursuits. He also co-founded and serves as the Executive Director for The Law Enforcement Work Inquiry System (“LEWIS”), where, in partnership with Microsoft Corporation, serves as a touchpoint between peace officers and the community. Dr. Salinas, a U.S. Marine, also held positions in banking and private equity.
“We are honored to welcome Dr. Salinas and his perspective on the commercialization and rapidly growing positive impacts of generative artificial intelligence, and the security thereof, on our markets and society overall,” stated Mr. Corrado De Gasperis, Comstock’s executive chairman and chief executive officer. “His direct work with GenMat has forged an alignment and productivity that complements the current competencies of our Board.”
Mr. Marting was elected to the board of directors of Comstock in April of 2018. He is the Founder and Managing Member of CereCare, LLC, D/B/A Brain Health Restoration since March 2017, a firm focused on providing breakthrough rehabilitation treatment for individuals, including numerous veterans, suffering from brain disease, traumatic brain injury and related substance use disorders, most commonly alcoholism and opioid addictions.
Mr. Marting is also a deeply experienced mining, financial, capital markets, transactional and corporate governance executive. Mr. Marting graduated from Yale University in 1969, with a BA in English and holds an MBA from Harvard Business School. Mr. Marting is a Navy veteran, including service with US Navy SEAL Team Two.
“Del’s experience and counsel has been invaluable over the past five years, including his long tenure as a member of our Audit Committee, which he will now lead,” continued Mr. Corrado De Gasperis, Comstock’s executive chairman and chief executive officer. “We are sorry to see Judd step down and could not be more appreciative of his contributions and leadership on our board. I consider him one of the most reliable, professional, trustworthy and productive professionals I have ever worked with. We wish him nothing but success in his future endeavors.”
About Comstock
Comstock (NYSE: LODE) commercializes innovative technologies that contribute to global decarbonization by efficiently converting under-utilized natural resources, primarily, woody biomass into net zero renewable fuels, end of life metal extraction, and generative AI-enabled advanced materials synthesis and mineral discovery.
This press release and any related calls or discussions may include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, are forward-looking statements. The words “believe,” “expect,” “anticipate,” “estimate,” “project,” “plan,” “should,” “intend,” “may,” “will,” “would,” “potential” and similar expressions identify forward-looking statements but are not the exclusive means of doing so. Forward-looking statements include statements about matters such as: future industry market conditions; future explorations or acquisitions; future changes in our exploration activities; future prices and sales of, and demand for, our products; land entitlements and uses; permits; production capacity and operations; operating and overhead costs; future capital expenditures and their impact on us; operational and management changes (including changes in the Board of Directors); changes in business strategies, planning and tactics; future employment and contributions of personnel, including consultants; future land sales; investments, acquisitions, joint ventures, strategic alliances, business combinations, operational, tax, financial and restructuring initiatives, including the nature, timing and accounting for restructuring charges, derivative assets and liabilities and the impact thereof; contingencies; litigation, administrative or arbitration proceedings; environmental compliance and changes in the regulatory environment; offerings, limitations on sales or offering of equity or debt securities, including asset sales and associated costs; and future working capital, costs, revenues, business opportunities, debt levels, cash flows, margins, taxes, earnings and growth. These statements are based on assumptions and assessments made by our management considering their experience and their perception of historical and current trends, current conditions, possible future developments, and other factors they believe to be appropriate. Forward-looking statements are not guarantees, representations or warranties and are subject to risks and uncertainties, many of which are unforeseeable and beyond our control and could cause actual results, developments, and business decisions to differ materially from those contemplated by such forward-looking statements. Some of those risks and uncertainties include the risk factors set forth in our filings with the SEC and the following: adverse effects of climate changes or natural disasters; adverse effects of global or regional pandemic disease spread or other crises; global economic and capital market uncertainties; the speculative nature of gold or mineral exploration, and lithium, nickel and cobalt recycling, including risks of diminishing quantities or grades of qualified resources; metal recycling, processing or mining activities; costs, hazards and uncertainties associated with precious metal based activities, including environmentally friendly and economically enhancing clean mining and processing technologies, precious metal exploration, resource development, economic feasibility assessment and cash generating mineral production; costs, hazards and uncertainties associated with metal recycling, processing or mining activities; contests over our title to properties; potential dilution to our stockholders from our stock issuances, recapitalization and balance sheet restructuring activities; potential inability to comply with applicable government regulations or law; adoption of or changes in legislation or regulations adversely affecting our businesses; permitting constraints or delays; ability to achieve the benefits of business opportunities that may be presented to, or pursued by, us, including those involving battery technology, quantum computing and advanced materials development, and development of cellulosic technology in bio-fuels and related carbon-based material production; ability to successfully identify, finance, complete and integrate acquisitions, joint ventures, strategic alliances, business combinations, asset sales, and investments that we may be party to in the future; changes in the United States or other monetary or fiscal policies or regulations; interruptions in our production capabilities due to capital constraints; equipment failures; fluctuation of prices for gold or certain other commodities (such as silver, zinc, lithium, nickel, cobalt, cyanide, water, diesel, gasoline and alternative fuels and electricity); changes in generally accepted accounting principles; adverse effects of war, mass shooting, terrorism and geopolitical events; potential inability to implement our business strategies; potential inability to grow revenues; potential inability to attract and retain key personnel; interruptions in delivery of critical supplies, equipment and raw materials due to credit or other limitations imposed by vendors; assertion of claims, lawsuits and proceedings against us; potential inability to satisfy debt and lease obligations; potential inability to maintain an effective system of internal controls over financial reporting; potential inability or failure to timely file periodic reports with the Securities and Exchange Commission; potential inability to list our securities on any securities exchange or market or maintain the listing of our securities; and work stoppages or other labor difficulties. Occurrence of such events or circumstances could have a material adverse effect on our business, financial condition, results of operations or cash flows, or the market price of our securities. All subsequent written and oral forward-looking statements by or attributable to us or persons acting on our behalf are expressly qualified in their entirety by these factors. Except as may be required by securities or other law, we undertake no obligation to publicly update or revise any forward-looking statements, whether because of new information, future events, or otherwise.
Neither this press release nor any related calls or discussions constitutes an offer to sell, the solicitation of an offer to buy or a recommendation with respect to any securities of the Company, the fund, or any other issuer.
Contact information:
Comstock Inc. P.O. Box 1118 Virginia City, NV 89440 www.comstock.inc
Investor Relations RB Milestone Group Tel (203) 487-2759 [email protected]
Zach Spencer Director of External Relations Tel (775) 847-5272 Ext.151 [email protected]
NEWTOWN, Pa., April 06, 2023 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova” or “the Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that its Chief Medical Officer (CMO) Mark Gelder, M.D., recently passed away unexpectedly. Michael Saunders, M.D., has been appointed the interim Chief Medical Officer of the Company.
“The entire Onconova family is deeply saddened by the loss of our beloved friend and colleague,” said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. “Dr. Gelder dedicated his career to caring for and improving the treatment options available to patients with cancer and his thought leadership and scientific passion will be sorely missed by the oncology community. Mark trained and worked as a gyn oncologist. Because of that experience, he was dedicated to advancing the care of women with reproductive tract cancers. Our goal is to complete the mission Mark started by advancing our trial in endometrial cancer and other cancers as well. We are immensely grateful for his many contributions to Onconova and express our deepest condolences to his family, friends, and colleagues during this difficult time. May he rest in peace.”
Dr. Gelder served as Onconova’s CMO since June 2021. He was an accomplished industry leader with more than 35 years of experience in clinical development, medical affairs, and medical marketing. His previously held the role of CMO at Elevar Therapeutics, Pierian Biosciences (formerly DiaTech Oncology), Accelovance, Inc., and Heron Therapeutics, Inc. Dr. Gelder also had extensive experience at large pharmaceutical companies including Pfizer, Wyeth, and Bayer. He earned his M.D. from the University of Virginia School of Medicine, completed a fellowship in gynecologic oncology, and was a Fellow of the American College of Physicians and the American College of Obstetrics and Gynecology.
Onconova’s Board of Directors will convene at an appropriate time to appoint a new CMO. A search is currently underway by the Company. Onconova does not expect any material impact to the stated timelines associated with its ongoing or planned clinical trials due to this sad news. The Company notes that Dr. Michael Saunders, a noted drug developer and colleague, has been working with Onconova as a consultant and is thus well acquainted with the Company’s compounds in development.
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 two separate and complementary Phase 1 dose escalation and expansion studies. These trials are currently underway in the United States and China. Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova is also planning a combination trial of narazaciclib with estrogen blockade in advanced endometrial cancer, as well as its clinical study in additional indications.
Onconova’s product candidate rigosertib is being studied in multiple investigator-sponsored studies, including 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, and a Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC).
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.
STAMFORD, Conn.–(BUSINESS WIRE)– Information Services Group (ISG) (Nasdaq: III), a leading global technology research and advisory firm, said today it will release its first-quarter financial results on Monday, May 8, 2023, at approximately 4:15 p.m., U.S. Eastern Time.
The firm will host a conference call with investors and industry analysts at 9 a.m., U.S. Eastern Time, the following day, Tuesday, May 9. Dial-in details are as follows:
The dial-in number for U.S. participants is +1 833-470-1428.
International participants should call +1 404-975-4839.
The security code to access the call is 417295.
Participants are requested to dial in at least five minutes before the scheduled start time.
A recording of the conference call will be accessible on ISG’s website (www.isg-one.com) for approximately four weeks following the call.
About ISG
ISG (Information Services Group) (Nasdaq: III) is a leading global technology research and advisory firm. A trusted business partner to more than 900 clients, including more than 75 of the world’s top 100 enterprises, ISG is committed to helping corporations, public sector organizations, and service and technology providers achieve operational excellence and faster growth. The firm specializes in digital transformation services, including automation, cloud and data analytics; sourcing advisory; managed governance and risk services; network carrier services; strategy and operations design; change management; market intelligence and technology research and analysis. Founded in 2006, and based in Stamford, Conn., ISG employs more than 1,600 digital-ready professionals operating in more than 20 countries—a global team known for its innovative thinking, market influence, deep industry and technology expertise, and world-class research and analytical capabilities based on the industry’s most comprehensive marketplace data. For more information, visit www.isg-one.com.
Vancouver, British Columbia–(Newsfile Corp. – April 6, 2023) – Maple Gold Mines Ltd. (TSXV: MGM) (OTCQB: MGMLF) (FSE: M3G) (“Maple Gold” or the “Company“) is pleased to report results from the final 20% of assays that were received from the previously completed 14,720 metres (“m”) of drilling at the 100%-controlled Eagle Mine Property (“Eagle”). The Company is also pleased to report that more than 7,000 m have now been completed (6,000 m planned) at the Telbel Mine area of the Joutel Project, which is held by a 50/50 joint venture (the “JV”) between the Company and Agnico Eagle Gold Mines Limited.
The final batch of assays received from completed drilling at Eagle correspond to approximately 3,000 m of the 14,720 m drilled to-date. The results continue to demonstrate continuity of mineralization and the potential significance of the multiple horizons/splays to the northwest of the former Eagle mine. Highlights include (see Table 1 and Figure 1 for highlighted results from all Maple Gold drilling at Eagle to-date):
EM-22-008W intersected 6.2 grams per tonne (“g/t”) gold (“Au”) over 2.0 m in the South Mine Horizon (“SMH”) and 4.2 g/t Au over 3.9 m in sediments further downhole.
EM-22-006W1 intersected multiple intercepts including 6.5 g/t Au over 1.2 m and 2.0 g/t Au over 3.0 m in the SMH and 2.3 g/t Au over 3.0 m at the microgabbro/Harricana sediment contact further downhole.
EM-22-006W4 intersected 4.0 g/t Au over 0.7 m within a broader 1.1 g/t Au over 14.2 m intercept within the SMH.
EM-22-017A intersected 2.9 g/t Au over 2.0 m and additional lower grade over broader near-surface intervals (1.0 g/t Au over 15.5 m from 93 m downhole).
“We have come along way since first consolidating the Joutel ground into our JV property package,” stated Matthew Hornor, CEO of Maple Gold. “All of our exploration and drilling work along the past-producing Eagle-Telbel mine trend is designed with the aim of defining high-grade zones of gold mineralization and additional mineral resources to complement the established potentially bulk-mineable resource present at Douay. Our first year of drilling at Eagle has more than covered our exploration spending commitments to earn a 100% interest and we are now in position to finalize our compilation and model updates to support focused follow-up drilling in areas we believe have the most promise to deliver additional high-quality ounces.”
Overview Summary and Key Takeaways from Drilling at Eagle
The Eagle-Telbel Mine trend produced 1.1 Moz at 6.5 g/t Au from 1974 – 1993, during a period when the price of gold averaged approximately $350 per ounce. During the first year of the JV (2021), all historical mining, stope and drilling data was digitized to underpin a new 3D geological model. The Company signed an option agreement to acquire a 100% interest in the Eagle Mine Property (see press release July 19, 2021) and has since completed more than 21,500 m of drilling across the 4 km long Eagle-Telbel Mine trend, with 14,720 m at Eagle (see Figure 1) and more than 7,000 m (assays pending) of JV drilling at Telbel.
The Company’s drilling to-date at Eagle has served to confirm that gold mineralization is not limited to a narrow stratigraphic interval (Eagle-Telbel Mine Horizon) but instead covers a significantly broader stratigraphic interval of over 100 m straddling the Harricana Deformation Zone. Drill core observations also support the Company’s concept of a significant structural component to gold mineralization in the form of an orogenic gold overprint.
Figure 1: Plan view map showing drilling to-date at Eagle with highlighted intercepts.
Several highlights from the Company’s first year of drilling at Eagle are summarized below (see Figure 1 above for locations):
EM-22-005: 4.0 g/t Au over 7.5 m, including 6.4 g/t Au over 3.0 m
EM-22-009: 11.4 g/t Au over 3 m, including 24.4 g/t Au over 1 m
EM-22-013: 2.3 g/t Au over 10.4 m, including 5.0 g/t Au over 3.2 m
EM-22-015: 10.3 g/t Au over 7.8 m, including 41.1 g/t Au over 1.0 m
EM-22-015: 4.3 g/t Au over 3.9 m, including 7.4 g/t Au over 1.5 m
EM-22-016: 3.1 g/t Au over 7.3 m, including 4.0 g/t Au over 3.6 m
When combining the Company’s drilling results and observations with notable historical results and new geophysical data, several priority target areas emerge along the SMH and North Mine Horizon (“NMH”); including multiple cross-plunging target concepts that will form part of the focus for the Company’s next phase of drilling (~5,000 m). The Company has initiated target definition and permitting work for a planned summer 2023 follow-up program at Eagle (see press release March 16, 2023) and priority follow-up targets will also be defined at Telbel once assay results have been received and interpreted from the first phase of deep drilling.
Figure 2: Oblique view showing SMH and NMH trends with grade contouring and highlighted pierce points with corresponding intercepts and target areas.
Table 2: Highlighted Assay Results from Maple Gold Drilling at Eagle to-date
Hole
UTME
UTMN
Azimuth
Plunge
Length (m)
From
To
Interval
Au g/t
EM-22-001
690565
5486334
40.6
-66.8
356.6
132.0
134.6
2.6
1.7
including
133.7
134.6
0.9
4.4
EM-22-002
690565
5486334
22.0
-52.4
243
183.2
185.0
1.8
2.1
EM-22-002
200.4
205.0
4.7
2.4
including
200.4
202.4
2.1
3.8
EM-22-003
690642
5486322
59.1
-70.5
288
Narrow intercepts <1 g/t Au
EM-22-004
690673
5486120
49.9
-56.0
288
139.0
141.0
2.0
1.2
EM-22-005
690758
5486043
22.6
-75.7
714
346.0
360.0
14.0
2.2
including
346.0
353.5
7.5
4.0
including
350.0
353.0
3.0
6.4
EM-22-006
690737
5485828
25.9
-63.2
777.75
539.3
543.0
3.7
1.3
EM-22-007
690736
5485826
23.9
-73.2
985
877.0
878.0
1.0
2.0
EM-22-009
690921
5485639
17.5
71.4
1009
920.4
921.0
0.6
10.8
EM-22-009
951.0
956.0
5.0
1.6
EM-22-009
984.0
993.0
9.0
4.0
EM-22-009
990.0
993.0
3.0
11.4
EM-22-009
991.0
993.0
2.0
15.5
including
992.0
993.0
1.0
24.4
EM-22-010
690841
5485795
32.5
-71.4
570
539.5
540.0
0.5
14.0
EM-22-010
543.0
544.0
1.0
8.3
EM-22-010W
690841
5485795
34.1
-61.2
932
921.0
922.0
1.0
3.7
EM-22-011
690547
5485859
56.7
-62
924
858.3
859.0
0.7
3.2
EM-22-012
691098.7
5485413
35.3
-78.6
1284
1232.2
1234.3
2.1
2.0
EM-22-013
690757.5
5486043
63.8
-69.8
327
257.0
267.4
10.4
2.3
including
257.0
260.2
3.2
5.0
EM-22-014
690565
5486334
64.5
-67.9
646
231.0
231.7
0.7
4.6
EM-22-015
690757.5
5486043
45
-50.1
408
142.5
148.6
6.1
1.6
EM-22-015
164.9
165.5
0.7
4.8
EM-22-015
217.1
221.0
3.9
4.3
including
218.5
220.0
1.5
7.4
EM-22-015
228.0
235.8
7.8
10.3
including
228.5
232.8
4.3
15.9
including
230.0
231.0
1.0
41.1
EM-22-015
246.7
248.4
1.7
4.3
including
247.5
248.4
0.9
7.1
EM-22-015
252.2
255.0
2.8
1.8
EM-22-016
690757.8
5486043
45.1
-62.6
297
193.0
206.2
13.2
2.2
including
193.0
200.3
7.3
3.1
including
196.0
199.6
3.6
4.0
EM-22-016
202.0
206.2
4.2
1.7
EM-22-017A
690643
5486322
41.3
-55.76
201
93.5
109.0
15.5
1.0
including
97.0
103.0
6.0
1.4
EM-22-017A
137.0
144.0
7.0
1.4
including
141.0
143.0
2.0
2.9
EM-22-005W
690795
5486136
2.2
-65.5
364
364.3
365.8
1.5
1.3
624.0
625.0
1.0
1.2
EM-22-006W1
690736.7
5485828
29.5
-57
435.2
476.0
479.0
3.0
2.0
EM-22-006W1
482.8
484.0
1.2
6.5
EM-22-006W1
652.0
655.0
3.0
2.3
including
653.5
654.1
0.6
6.6
EM-22-009W2A
690921
5485639
21.4
-65.9
634
828.0
830.0
2.0
1.4
EM-22-010W1
690841
5485795
30.8
-62
361
583.5
584.0
0.5
1.5
EM-22-008W
690737
5485828
45.6
-58.1
377
527.0
529.0
2.0
6.2
EM-22-008W
630.1
634.0
3.9
4.2
including
631.0
632.5
1.5
6.8
EM-23-006W4
690737
5485828
24.5
-39.4
236
472.0
486.2
14.2
1.1
including
472.0
477.4
5.4
1.4
including
481.6
482.3
0.7
4.0
EM-23-006W4
521.0
523.6
2.6
1.9
EM-22-012W
691098.7
5485413
20
-45.6
524.7
1095.3
1097.4
2.1
1.2
Notes: Drill holes EM-22-006W, EM-22-006X, EM-22-008 and EM-22-009W1 returned no significant assays. Drill hole EM-22-017 was lost at 51 m. True widths estimated at 40% to 70% of downhole width depending on the hole inclination.
Qualified Person
The scientific and technical data contained in this press release was reviewed and prepared under the supervision of Fred Speidel, M. Sc., P. Geo., Vice-President Exploration of Maple Gold. Mr. Speidel is a Qualified Person under National Instrument 43-101 Standards of Disclosure for Mineral Projects. Mr. Speidel has verified the data related to the exploration information disclosed in this press release through his direct participation in the work.
Quality Assurance (QA) and Quality Control (QC)
The Company implements strict Quality Assurance (“QA”) and Quality Control (“QC”) protocols at Eagle covering the planning and placing of drill holes in the field; drilling and retrieving the NQ-sized drill core; drill hole surveying; core transport; core logging by qualified personnel; sampling and bagging of core for analysis; transport of core from site to the Val d’Or, Québec AGAT laboratory; sample preparation for assaying; and analysis, recording and final statistical vetting of results. Check assays for gold are being done on a sample subset at ALS’ laboratory in Val d’Or. For a complete description of protocols, please visit the Company’s QA/QC webpage at www.maplegoldmines.com.
About Maple Gold
Maple Gold Mines Ltd. is a Canadian advanced exploration company in a 50/50 joint venture with Agnico Eagle Mines Limited to jointly advance the district-scale Douay and Joutel gold projects located in Québec’s prolific Abitibi Greenstone Gold Belt. The projects benefit from exceptional infrastructure access and boast ~400 km2 of highly prospective ground including an established gold resource at Douay (SLR 2022) that holds significant expansion potential as well as the past-producing Eagle, Telbel and Eagle West mines at Joutel. In addition, the Company holds an exclusive option to acquire 100% of the Eagle Mine Property.
The district-scale property package also hosts a significant number of regional exploration targets along a 55 km strike length of the Casa Berardi Deformation Zone that have yet to be tested through drilling, making the project ripe for new gold and polymetallic discoveries. The Company is well capitalized and is currently focused on carrying out exploration and drill programs to grow resources and make new discoveries to establish an exciting new gold district in the heart of the Abitibi. For more information, please visit www.maplegoldmines.com.
ON BEHALF OF MAPLE GOLD MINES LTD.
“Matthew Hornor”
B. Matthew Hornor, President & CEO
For Further Information Please Contact:
Mr. Joness Lang Executive Vice-President Cell: 778.686.6836 Email: [email protected]
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 PRESS RELEASE.
Forward Looking Statements:
This press release contains “forward-looking information” and “forward-looking statements” (collectively referred to as “forward-looking statements”) within the meaning of applicable Canadian securities legislation in Canada, including statements about exploration work and results from current and future work programs. Forward-looking statements are based on assumptions, uncertainties and management’s best estimate of future events. Actual events or results could differ materially from the Company’s expectations and projections. Investors are cautioned that forward-looking statements involve risks and uncertainties. Accordingly, readers should not place undue reliance on forward-looking statements. For a more detailed discussion of such risks and other factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements, refer to Maple Gold Mines Ltd.’s filings with Canadian securities regulators available on www.sedar.com or the Company’s website at www.maplegoldmines.com. The Company does not intend, and expressly disclaims any intention or obligation to, update or revise any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.
