COMPANY TO SHARE UPDATED RESULTS FROM ONGOING PHASE 1/2 TRIAL OF OCU400 FOR THE TREATMENT OF RETINITIS PIGMENTOSA AND LEBER CONGENITAL AMAUROSIS
MALVERN, Pa., Sept. 12, 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 September 13, 2023 at 8:30 a.m. ET. During the webcast and conference call, members of the Ocugen leadership team and key opinion leaders will discuss updated 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, Principal investigator of the study
Byron L. Lam, MD, Mark J. Daily Professor, Bascom Palmer Eye Institute, University of Miami, Principal investigator of the study
Lejla Vajzovic, MD, FASRS, Associate Professor of Ophthalmology with Tenure, Director of Duke Vitreoretinal Fellowship Program at Duke Eye Center and Duke University School of Medicine and leader in gene-therapy research
Webcast and Conference Call Details
Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers Conference ID: 7803227
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 presentation 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 include, but are not limited to, statements regarding our clinical development activities and related anticipated timelines. 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 presentation speak only as of the date of this presentation. Except as required by law, we assume no obligation to update forward-looking statements contained in this presentation whether as a result of new information, future events, or otherwise, after the date of this presentation.
Contact: Tiffany Hamilton Head of Communications IR@ocugen.com
Updates Presented for Gedeptin® and GEO-CM04S1 Phase 2 Clinical Trials
ATLANTA, GA, September 12, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that its Chairman and CEO, David Dodd, presented a company overview during the H.C. Wainwright 25th Annual Global Investment Conference on September 11. A webcast replay of Mr. Dodd’s presentation can be viewed here.
During his presentation, Mr. Dodd reviewed the Company’s four ongoing Phase 2 clinical trials:
GEO-CM04S1 (Next-Generation COVID-19 Vaccine)
As a primary vaccine in immunocompromised patients (with hematologic cancers receiving cell transplants or CAR-T therapy). gov Identifier: NCT04977024.
As a booster vaccine in immunocompromised patients with chronic lymphocytic leukemia (CLL), a recognized high-risk group for whom current mRNA vaccines and monoclonal antibody (MAb) therapies appear inadequate relative to providing protective immunity. ClinicalTrials.gov Identifier: NCT05672355.
As a booster vaccine for healthy patients who have previously received the Pfizer or Moderna mRNA vaccine. gov Identifier: NCT04639466.
Gedeptin® (Gene Therapy for Solid Tumors)
Evaluating the safety and efficacy of repeat cycles of Gedeptin therapy in patients with recurrent head and neck cancers whose tumor(s) are accessible for injection and who have no curable treatment options.gov Identifier: NCT03754933.
Commenting on the GEO-CM04S1 clinical program, Mr. Dodd said, “Our next-generation COVID-19 vaccine is designed to provide critically needed protection to those individuals with depleted immune systems, and who are inadequately protected by the currently authorized vaccines and monoclonal antibody therapies. Using our MVA platform as its backbone, our vaccine candidate is “variant-agnostic” and we expect it to provide broader, more durable protection than existing authorized vaccines. We anticipate multiple significant catalyst events during the remainder of 2023. We recently completed patient enrollment in the healthy booster trial, and anticipate completion of enrollment in our CLL trial soon, while also accelerating enrollment in the cell transplant trial through multi-site expansion. We also believe our vaccine to be an excellent example of next-generation vaccines, providing more robust and durable protection, especially for immunocompromised individuals who don’t adequately respond to the currently authorized COVID-19 vaccines or monoclonal antibody therapies.”
Regarding the Gedeptin program, Mr. Dodd stated, “We expect to soon complete the first stage of this study, which is being funded in part by the U.S. Food and Drug Administration (FDA) pursuant to its Orphan Products Clinical Trials Grants Program, and then initiate an expanded Phase 2 trial focused on expedited FDA registration. We are excited about the potential for the Gedeptin “tumor-agnostic” platform, which may include expanded development, both as monotherapy and combination therapy in conjunction with therapies such as immune checkpoint inhibitors. Possible expansion indications include breast, prostate, and pancreatic cancers, among other solid tumors. This program also offers multiple opportunities for global strategic collaborations and partnerships.”
Mr. Dodd’s concluding comments focused on GeoVax’s advancements made in its MVA manufacturing process in transforming to a high-yield, high-capacity continuous cell line system, as well as the Company’s efforts for achieving expedited registration for the first U.S.-sourced vaccine against Mpox and smallpox. Mr. Dodd said, “Our progress in developing a continuous avian cell line system is nothing short of transformative for manufacturing our MVA-based vaccines and immunotherapies, and we recently partnered with Advanced Bioscience Laboratories, Inc. to support the production of our MVA-based products through late-stage development and eventual commercialization. Additionally, the recent expansion of our GEO-CM04S1 rights to include development for Mpox and smallpox adds to other rights we previously secured from the NIH covering preclinical, clinical, and commercial uses of the NIH-MVA. This provides a compelling opportunity to leverage our MVA-based vaccine expertise and help expand the global public health supply options available for the worldwide public health threats posed by SARS-CoV-2, Mpox, and smallpox.”
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
Fall FlavorsGet a Sweet Spinat Original Frozen Slab Concept
LOS ANGELES, Sept. 12, 2023 (GLOBE NEWSWIRE) — Marble Slab Creamery, the imaginative small-batch ice cream franchise that never fails to dream up the ultimate flavor combinations, announces its brand-new flavor offering – Caramel Churro Crunch. Available as an Ice Cream or a Shake, the autumn-inspired flavor is sure to take guests’ tastebuds straight to sweater weather.
Caramel Churro Crunch Ice Cream is made using Marble Slab Creamery’s original frozen slab technique. It starts with creamy Sweet Cream Ice Cream and is then swirled with caramel sauce and mini crunchy churros. The Marble Slab Creamery Caramel Churro Crunch Shake is a blend of Sweet Cream Ice Cream, mini crunchy churros, and a swirl of caramel sauce, all topped with whipped cream and crushed mini churros. The tasty but limited-time treat is available starting today and runs through Oct. 31.
For 40 years, Marble Slab Creamery has been an innovator in the ice cream space, creating the frozen slab technique and offering homemade, small-batch Ice Cream with always free Mix-Ins, Shakes in a variety of flavors, and Ice Cream Cakes. The leading chain boasts over 375 locations and continues to expand across the globe, most notably with its cookie sister brand, Great American Cookies, providing guests with the ultimate destination for sweet treats.
“Churro continues to be a trending flavor profile we couldn’t help but lean into for fall,” said Katie Thoms, Senior Director of Marketing at FAT Brands’ Quick Service Division. “We’re proud of this decadent flavor combination we’ve created and know our fans will love to cozy up with a cup, cone or shake.”
About FAT (Fresh. Authentic. Tasty.) Brands FAT Brands (NASDAQ: FAT) is a leading global franchising company that strategically acquires, markets and develops fast casual, casual and polished casual dining restaurant concepts around the world. The Company currently owns 17 restaurant brands: Round Table Pizza, Fatburger, Marble Slab Creamery, Johnny Rockets, Fazoli’s, Twin Peaks, Great American Cookies, Hot Dog on a Stick, Buffalo’s Cafe & Express, Hurricane Grill & Wings, Native Grill & Wings, Pretzelmaker, Elevation Burger, Yalla Mediterranean and Ponderosa and Bonanza Steakhouses, and franchises and owns over 2,300 units worldwide. For more information on FAT Brands, please visit http://www.fatbrands.com.
About Marble Slab Creamery Since dreaming up the frozen slab technique and serving fresh homemade, small-batch Ice Cream in-store since 1983, Marble Slab Creamery has always known how to dream big. We sprinkle our customers with imagination and promise to inspire with infinite Ice Cream possibilities to feed your curiosity and capture cravings. With our always-free mix-in philosophy, delicious Ice Cream and Shakes in a variety of flavors, hand-rolled waffle cones, and Ice Cream Cakes, imagination has no limits. Today, Marble Slab Creamery is enjoyed by consumers across the globe with locations in Bahrain, Canada, Kuwait, Saudi Arabia, Guam, Puerto Rico, and the United States. For more information, visit www.marbleslab.com.
The “Imagine Success” Podcast Will Help Listeners Gain Insights and Inspiration from Conversations with Industry Leaders and Small Business Owners
BOCA RATON, Fla.–(BUSINESS WIRE)–Sep. 12, 2023– Office Depot, a leading omnichannel retailer dedicated to helping its small business, home office, and education clients live more productive and organized lives through innovative products and services, today announced the launch of a new podcast series called “Imagine Success,” available now at officedepot.com/podcast and on major podcast platforms including Spotify and Apple Podcasts. The series will include thought-provoking conversations to inspire entrepreneurs and help guide them through the various stages of a business’s life cycle, from taking the leap to building a brand to identifying sources of funding, scaling for growth, conquering challenges and more.
Hosted by Kevin Moffitt, executive vice president of The ODP Corporation and president of Office Depot, the podcast series features real-world strategies and stories from industry leaders and small business owners alike. Through these stories, guests will educate and inspire others to achieve their own version of success.
“At Office Depot, we’re always striving to find new, innovative ways to enable success for small business owners,” said Moffitt. “We hope listeners of the podcast will find practical insights, valuable takeaways and actionable tips from each episode that will empower them to pursue their passions and achieve their business goals.”
As the proud son of small business owners who’ve opened four different businesses since the mid-1970s, Moffitt kicks off the podcast’s debut episode in conversation with his parents, Bertha and Victor Moffitt. The first episode of the Imagine Success podcast explores putting a business idea into motion and also features interviews with Brit Morin and Justine Pon. Morin is a venture capitalist, serial entrepreneur and founder and CEO of Brit + Co, a modern lifestyle and education company, plus Selfmade, an educational platform that Office Depot has been a proud sponsor of since 2020, that helps female founders start and grow their own businesses. Pon is the founder of The Ponnery, an arts and crafts product company that celebrates Asian American food and culture.
Visit officedepot.com/podcast to listen to the podcast and discover innovative products and helpful services designed to support small business owners.
About Office Depot
Office Depot, LLC, an operating company of The ODP Corporation, is a leading specialty retailer providing innovative products and services delivered through a fully integrated omnichannel platform of Office Depot and OfficeMax retail stores and an award-winning online presence, OfficeDepot.com, to support the productivity and organization of its small business, home office and education clients. Office Depot is committed to enabling its clients’ success, strengthening local communities and providing equal opportunities for all. For more information, visit officedepot.com, download the Office Depot app on your iPhone or Android and follow @officedepot on Facebook, Twitter, Instagram and TikTok.
Office Depot is a trademark of The Office Club, LLC. OfficeMax is a trademark of OMX, Inc. ODP and ODP Business Solutions are trademarks of ODP Business Solutions, LLC. Veyer is a trademark of Veyer, LLC. Varis is a trademark of Varis, Inc. Any other product or company names mentioned herein are the trademarks of their respective owners.
VANCOUVER, BC, Sept. 12, 2023 /CNW/ – Defense Metals Corp. (“Defense Metals” or the “Company“) (TSXV: DEFN) (OTCQB: DFMTF) (FSE: 35D) is pleased to announce an updated Mineral Resource Estimate (the 2023 MRE) for the development of its Wicheeda Rare Earth Element (REE) deposit located in British Columbia, Canada.
Highlights of the 2023 Wicheeda REE Deposit Mineral Resource Estimate
The 2023 MRE comprises a:
6.4 million tonne Measured Mineral Resource, averaging 2.86% Total Rare Earth Oxide (TREO1);
a 27.8 million tonne Indicated Mineral Resource, averaging 1.84 % TREO;
and an 11.1 million tonne Inferred Mineral Resource, averaging 1.02% TREO,
all reported at a cut-off grade of 0.5% TREO within a conceptual open pit shell;
Total Measured and Indicated (M+I) Mineral Resources of 34.2 million tonnes, averaging 2.02% TREO, is a significant upgrade representing a conversion of 101% of the 2021 MRE comprising some indicated and mostly inferred resources (see Defense Metals’ news release of November 24, 2021) to M+I on a contained metal basis;
Measured and Indicated resources are inclusive of 17.8 million tonnes of dolomite carbonatite, averaging 2.92% TREO;
The 2023 MRE represents a 17% increase in TREO on a contained metal basis, or 31% tonnage increase, in comparison to the prior 2021 MRE.
The 2023 MRE is based on an updated geological model that incorporates an additional 10,350 metres of drillhole data, from 45 holes drilled by Defense Metals during 2021 and 2022.
Craig Taylor, CEO of Defense Metals, stated, “Defense Metals is excited to release our updated mineral resource estimate for the Wicheeda Deposit, one of North Americas most advanced Rare Earth development projects. With over 10,000 metres of additional drilling completed since our 2021 mineral resource we have now converted 100% of the that resource to the measured and indicated categories, in addition to growing the overall resource by 17%. Importantly, we believe the upgrading of resources now demonstrates that we have established the tonnage and grades necessary to carry forward into our ongoing preliminary feasibility study.”
The effective date of the 2023 MRE is August 28, 2023, and a technical report relating to the PEA will be filed on SEDAR within 45 days of this news release. The 2023 MRE was prepared by APEX Geoscience Ltd. (APEX).
2023 Mineral Resource
The Wicheeda REE deposit is a southeast-trending, north to northeast dipping syenite-carbonatite intrusive complex having dimensions of approximately 450 m north-south by 250 m east-west which intrudes a mixed sedimentary host rock package (limestone). Relatively high REE grade dolomite-carbonatite rocks, which outcrop at surface, and form the main body of REE mineralization are surrounded by an envelope of intermediate REE grade hybrid xenolithic-carbonatite rocks that intrude lower REE grade syenite.
The 2023 MRE comprises a 6.4 million tonne Measured Mineral Resource, averaging 2.86% TREO CeO2, La2O3, Nd2O3, Pr6O11, Sm2O3, Eu2O3, Gd2O3, Tb4O7, Dy2O3 and Ho2O3); 27.8 million tonne Indicated Mineral Indicated Resource, averaging 1.84% TREO; and 11.1 million tonne Inferred Mineral Resource, averaging 1.02% TREO, reported at a cut-off grade of 0.5% TREO within a conceptual Pseudoflow algorithm open pit shell; see Table 1 and Figure 1.
The 2023 MRE is based on an updated geological model incorporating an additional 10,350 metres of drilling within 45 holes drilled by Defense Metals during 2021 and 2022.
Notes for Resource Table:
The 2023 MRE is classified according to the CIM “Estimation of Mineral Resources and Mineral Reserves Best Practice Guidelines” dated November 29th, 2019 and CIM “Definition Standards for Mineral Resources and Mineral Reserves” dated May 10th, 2014.
The 2023 MRE was prepared by Warren Black,M.Sc., P.Geo. and Tyler Acorn, M.Sc., of APEX Geoscience Ltd under the supervision of the QP, Michael Dufresne, M.Sc., P.Geo. in accordance with CIM Definition Standards.
Mineral Resources that are not Mineral Reserves do not have demonstrated economic viability. There has been insufficient exploration to allow for the classification of the indicated and inferred resources tabulated as a measured mineral resource; however, it is reasonably expected that the majority of the indicated and inferred mineral resources could be upgraded to measured or indicated mineral resources with continued exploration. There is no guarantee that any part of the mineral resources discussed herein will be converted to a mineral reserve in the future.
All figures are rounded to reflect the relative accuracy of the estimates. Totals may not sum due to rounding.
Median rock densities are supported by 8,075 measurements applied: 2.95 g/cm3 (mineralized dolomite-carbonatite), 2.90 g/cm3 (unmineralized dolomite-carbonatite), 2.85 g/cm3 (mineralized xenolithic-carbonatite), 2.76 g/cm3 (unmineralized xenolithic-carbonatite), 2.73 g/cm3 (syenite), and 2.76 g/cm3 (limestone).
The reasonable prospect for eventual economic extraction is met by reporting the Mineral Resources at a cut-off grade of 0.50% TREO (total rare earth oxide, sum of 10 oxides: CeO2, La2O3, Nd2O3, Pr6O11,Sm2O3,Eu2O3, Gd2O3, Tb4O7, Dy2O3 and Ho2O3), contained within an optimized open pit shell.
The cut-off grade is calculated, and the open pit shell is optimized based on the assumption that the hydrometallurgical processing can produce mixed REE carbonate precipitates. The parameters utilized, as in the 2021 MRE, include the following considerations:
TREO price: $18.66/kg
Exchange rate of 1.30 C$:US$
Precipitate production grades of 81.09% of TREO
Processing costs include $21.47/t of mill feed for flotation plus a variable cost for hydrometallurgical plant that varies based on the feed grade. The average cost of hydrometallurgical plant is assumed to be $1,204/t of concentrate.
Mining cost of C$2.00/t for mill feed and waste
G&A Costs of C$3.33/t for mill feed.
The overall process recoveries: For TREO>=2.3%, recovery is 69.6%; between 2.3% and 1.5% TREO, recovery is 65.3%; and less than 1.5% TREO, recovery is 52.2%. These assume variable flotation recoveries and a constant 87% hydrometallurgical recovery.
Overall pit slope angles vary by zone between 40 and 48 degrees.
Figure 1: Cross Section of the Wicheeda RE Deposits 2023 MRE (CNW Group/Defense Metals Corp.)
The 2023 MRE for the Wicheeda REE Deposit includes inferred mineral resources that are considered too speculative geologically to have the economic considerations applied to them that would enable them to be categorized as mineral reserves. Mineral resources that are not mineral reserves do not have demonstrated economic viability.
Mineral Resource Estimate Methodology
The drillhole database comprised of drilling that intersected the estimation domains consists of 14 exploration diamond drillholes (totalling 2,107 meters) completed in 2008 and 2009 by Spectrum Mining and 58 exploration core drillholes during 2019, 2021 and 2022 by Defense Metals (totalling 12,073 metres), providing a total of 4,903 drill core samples analyzed for REE by multi-element fusion ICP-MS.
The 3D geological modeling integrates assay and geological data collected from diamond core drilling; surface geologic mapping; soil geochemical; and airborne magnetic and radiometric geophysical surveys.
Ordinary kriging is employed to estimate metal concentrations using a three-step pass search strategy guided by domain-specific variography. The estimates utilize capped composites with a 3-meter length.
Measured Resources are categorized within a search ellipse of 35 m by 30 m by 15 m with a minimum of 3 drillholes. Indicated Resources are categorized within a search ellipse of 90 m by 60 m by 30 m with a minimum of 3 drillholes. Inferred Resources are categorized within a search ellipse of 120 m by 120 m by 30 m with a minimum of 2 drillholes.
Table 2 above illustrates the sensitivity of the 2023 MRE to different cut-off grades for a potential open-pit operation scenario with reasonable outlook for economic extraction. The reader is cautioned that the figures provided in these tables should not be interpreted as a statement of mineral resources. Quantities and estimated grades for different cut-off grades are presented for the sole purpose of demonstrating the sensitivity of the resource model to cut-off grade.
Table 3: Wicheeda Mineral Resource by Lithology (cut-off grade of 0.5% TREO)
Table 3 above illustrates the 2023 MRE by lithology which illustrates the relatively high REE grade nature of the dominant dolomite carbonatite unit, intermediate grade xenolithic dolomite carbonate rocks and lower grade syenite and limestone lithologies peripheral to the main body of the Wicheeda REE Deposit.
Qualified Persons
The scientific and technical information contained in this news release as it relates to the Wicheeda REE Project has been reviewed and approved by Kristopher J. Raffle, P.Geo. (BC), Principal and Consultant of APEX Geoscience Ltd. of Edmonton, AB, a director of Defense Metals and a “Qualified Person” as defined in NI 43-101. Mr. Raffle verified the data disclosed which includes a review of the analytical and test data underlying the information and opinions contained therein.
About the Wicheeda REE Property
Defense Metals 100% owned, 6,759-hectare (~16,702-acre) Wicheeda Project is located approximately 80 km northeast of the city of Prince George, British Columbia, Canada; population 77,000. The Wicheeda Project is readily accessible by all-weather gravel roads and is near infrastructure, including hydropower transmission lines and gas pipelines. The nearby Canadian National Railway and major highways allow easy access to the deep-water port facilities at Prince Rupert, the closest major North American port to Asia.
About Defense Metals Corp.
Defense Metals Corp. is a mineral exploration and development company focused on the development of its 100% owned Wicheeda 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/
National Instrument 43-101 Technical Report
A technical report for the Wicheeda Project will be prepared in accordance with National Instrument 43-101 and will be filed on SEDAR at www.sedarplus.ca and on the Defense Metals’ website within 45 days of this news release. Readers are encouraged to read the technical report in its entirety, including all qualifications, assumptions and exclusions that relate to the details summarized in this news release. The technical report is intended to be read as a whole, and sections should not be read or relied upon out of context.
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 completion of the PFS and the expected timelines, the completion of the environmental tests on flotation and hydrometallurgical and the expected timelines, advancing the Wicheeda REE Project, 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.sedarplus.ca. 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.
Activation of multiple inflammasome pathways contributes to pathological inflammation in neurodegenerative (“CNS”) diseases, such as amyotrophic lateral sclerosis (“ALS”)
This study showed that NLRP3 inhibition alone was inadequate to address CNS inflammation in a mouse model of ALS
ZyVersa is developing Inflammasome ASC Inhibitor IC 100, designed to inhibit up to 12 different inflammasomes (including NLRP3 inflammasomes) and their associated ASC specks to control damaging inflammation in CNS and non-CNS inflammatory diseases
WESTON, Fla., Sept. 12, 2023 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, announces publication of a paper in the peer-reviewed journal, Frontiers in Immunology, highlighting potential limitations of NLRP3 inhibition in attenuating CNS Inflammation associated with activation of multiple inflammasome pathways. This paper supports ZyVersa’s rationale for targeting inflammasome ASC with IC 100 to inhibit multiple inflammasome pathways, not just NLRP3, to control inflammation in various inflammatory diseases.
In the paper titled, “Divergent functional outcomes of NLRP3 blockade downstream of multi-inflammasome activation: therapeutic implications for ALS,” the authors conducted studies in various human cell lines and in an animal model of ALS. Data demonstrate that NLRP3 inhibition alone is insufficient to attenuate proinflammatory cytokine release and inflammatory cell death associated with activation of multiple inflammasome pathways. Likewise, NLRP3 inhibition alone did not ameliorate spinal cord inflammation in an ALS model.
The authors stated, “we hypothesize that strategies that impact multiple inflammasome pathways may hold more promise in CNS disorders like ALS where multiple inflammasomes are dysregulated.” To read the article Click Here.
“The research published in Frontiers in Immunology reinforces the need to inhibit more than the NLRP3 inflammasome pathway to control inflammation associated with activation of multiple inflammasomes,” commented Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO and President. “ZyVersa’s Inflammasome ASC inhibitor IC 100 is designed to inhibit formation of multiple types of inflammasomes to attenuate initiation of the inflammatory cascade, and to inhibit ASC specks to attenuate perpetuation of damaging inflammation.” To review a white paper summarizing the mechanism of action and preclinical data for IC 100, Click Here.
About Inflammasome ASC Inhibitor IC 100
IC 100 is a novel humanized IgG4 monoclonal antibody that inhibits the inflammasome adaptor protein ASC. IC 100 was designed to attenuate both initiation and perpetuation of the inflammatory response. It does so by binding to a specific region of the ASC component of multiple types of inflammasomes, including NLRP1, NLRP2, NLRP3, NLRC4, AIM2, Pyrin. Intracellularly, IC 100 binds to ASC monomers, inhibiting inflammasome formation, thereby blocking activation of IL-1β early in the inflammatory cascade. IC 100 also binds to ASC in ASC Specks, both intracellularly and extracellularly, further blocking activation of IL-1β and the perpetuation of the inflammatory response that is pathogenic in inflammatory diseases. Because active cytokines amplify adaptive immunity through various mechanisms, IC 100, by attenuating cytokine activation, also attenuates the adaptive immune response.
About ZyVersa Therapeutics, Inc.
ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs for patients with renal and inflammatory diseases who have significant unmet medical needs. The Company is currently advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 for treatment of kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and other inflammatory diseases. For more information, please visit www.zyversa.com.
Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management’s intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc (“ZyVersa”) uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa’s plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa’s planned preclinical and clinical trials; the timing of the availability of data from ZyVersa’s preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa’s plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa’s product candidates; ZyVersa’s commercialization, marketing and manufacturing capabilities and strategy; ZyVersa’s ability to protect its intellectual property position; and ZyVersa’s estimates regarding future revenue, expenses, capital requirements and need for additional financing.
New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.
This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities.
Corporate and IR Contact: Karen Cashmere Chief Commercial Officer kcashmere@zyversa.com 786-251-9641
BY THE COMTECH EDITORIAL TEAM – SEP 12, 2023 | 3 MIN READ
Solutions uniquely designed to BRIDGE the digital divide and complement existing networks
MELVILLE, N.Y. – Sept. 12, 2023–Comtech (NASDAQ: CMTL) today launched its new blended, resilient, integrated, digital, global, end-to-end (BRIDGE) connectivity solutions. Comtech’s BRIDGE solutions provide portable, adaptable, full-service communications networks that can be established in a matter of hours and help “bridge the gap” for traditional satellite and terrestrial infrastructures.
Comtech’s BRIDGE solutions are designed to be infrastructure, cloud, and application agnostic-enabling new options for interoperable connectivity services and applications in the world’s most challenging geographies. (Photo: Business Wire)
Comtech’s BRIDGE solutions are designed to overcome geographical and environmental challenges to deliver robust and resilient connectivity to places where it was previously unavailable or overlooked. The company’s BRIDGE solutions are tailored to meet urgent needs of initial customer sets including emergency service providers, remote communities, military operators, and maritime customers.
“Our new BRIDGE connectivity solutions align with our mission to democratize access to communications technologies and empower a truly connected planet,” said Ken Peterman, President and CEO, Comtech. “As the name implies, Comtech’s BRIDGE solutions will play a significant role in bridging the digital divide and delivering connectivity to commercial and government customers when and where it matters most. BRIDGE provides a brand-new layer of connectivity that complements existing satellite and terrestrial services to keep people connected and help usher in a new era of unified hybrid network architectures that will enable always-on, ubiquitous global connectivity.”
Comtech’s BRIDGE solutions are designed to be infrastructure, cloud, and application agnostic-enabling new options for interoperable connectivity services and applications in the world’s most challenging geographies. With Comtech’s software-defined technology embedded at the core, BRIDGE solutions can continuously evolve over time to meet emerging government and commercial use cases as well as support future smart-enabled networks across a variety of global markets and geographies.
The company’s BRIDGE solutions deliver vital information both line of sight (LOS) as well as hundreds of miles over the horizon, or beyond-line-of-sight (BLOS). Inclement weather, which can interfere with satellite and terrestrial networks, enhances the performance of Comtech’s BRIDGE solutions-allowing this new technology to bridge the gap when other communications networks are unavailable.
Over the summer, Comtech began introducing BRIDGE to select customers. In August, the company successfully completed multiple proof of concept demonstrations for its BRIDGE solutions for maritime users. During the customer demonstrations, the BRIDGE solutions showcased unique, robust, and resilient ship-to-shore connectivity-delivering reliable on the move communications capabilities nearly 70 miles from shore.
BRIDGE solutions are now available for U.S. and international customers including:
Emergency Response: Following broad scale natural disasters such as hurricanes, communications infrastructure is often heavily impacted. BRIDGE offer a new mechanism to rapidly restore connectivity infrastructures, which can help keep communities connected and enhance disaster relief efforts.
Maritime: BRIDGE solutions provide maritime customers with unique BLOS ship-to-ship and ship-to-shore long distance, high throughput communications capabilities on the move. BRIDGE provides a new alternative to maritime satellite and cellular communications capabilities.
Military Operations: BRIDGE deliver new network agnostic, resilient and secure BLOS communications capabilities designed significantly improve situational awareness for U.S. and coalition forces. Comtech’s BRIDGE solutions also create new interoperable connectivity layers needed to enhance Combined Joint All Domain Command and Control (CJADC2) operations.
Remote Communities: BRIDGE serves as a cost-effective and reliable solution to provide high-speed internet access to remote areas and isolated towns where access to satellite and cellular service remains unavailable.
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.
IRVING, Texas–(BUSINESS WIRE)– Salem Media Group, Inc. (NASDAQ: SALM) announced today the launch of the podcast show Hearing Jesus for Kids on Salem-owned LifeAudio Podcast Network. The Hearing Jesus for Kids podcast is a daily audio program designed to help kids explore the fascinating stories of the Bible and apply the lessons they learn to their everyday lives. Following the success of the Hearing Jesus podcast, which consistently ranks in the top 200 charts on Apple Podcasts for Religion & Spirituality, host Rachael Groll has expanded her creativity and knowledge to reach the next generation of Christians with this new companion show.
“Sometimes people think that the Bible is just for adults, but God actually really wants kids to know about Him,” Rachael Groll said. “On this podcast, we are going to learn all about God’s big story and how he shows Himself to us through the Bible.”
The pilot episode, available on all podcast platforms, uncovers hidden stories of brave heroes, epic battles, and amazing miracles that set the stage for the arrival of Jesus.
ABOUT RACHAEL GROLL:
Rachael Groll is the host of the Hearing Jesus podcast, one of Apple Podcasts’ most successful shows. As a pastor, missionary and author, her greatest calling in life is to help women learn how to hear the Lord more clearly in their lives. Rachael has served both locally and globally, focusing on evangelism and discipleship, and counts it a privilege to share God’s Word on the podcast every week. Rachael has her undergraduate degree in Ministerial Leadership from Southeastern University and received her MA in Bible Exposition at Biola University in May. Rachael is the author of She Hears: Learning to Listen to Jesus as well as numerous other titles. She and her husband, Tim, live in rural Pennsylvania and have three beautiful daughters. Find more from Rachael at her website, shehears.org.
ABOUT LIFEAUDIO PODCAST NETWORK:
For more than 20 years, Salem Web Network has delivered inspirational Christian content all over the world through some of the most recognizable brands in Christian media. Now, with LifeAudio Podcast Network, we are proud to offer a suite of captivating and original new audio content from trusted pastors, authors, and ministry leaders. Home to top-charting shows like Your Daily Prayer, Abide Bible Sleep Meditation and The Becket Cook Show, LifeAudio is proud to bring entertaining, life-changing, and family-friendly podcasts for the engaged, evangelical Christian audience. Learn more about us on Facebook, Twitter/X, Instagram and TikTok.
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.
NEW ALBANY, Ohio, Sept. 11, 2023 (GLOBE NEWSWIRE) — CVG (NASDAQ: CVGI) announced today that Andy Cheung, Chief Financial Officer, will meet with investors at the D.A. Davidson Annual Diversified Industrials & Services Conference on September 21-22, 2023.
At CVG, we deliver real solutions to complex design, engineering and manufacturing problems while creating positive change for our customers, industries, and communities we serve. Information about the Company and its products is available on the internet at www.cvgrp.com.
Investor Relations Contact: Ross Collins or Stephen Poe Alpha IR Group CVGI@alpha-ir.com
Multi-antigen Vaccine Designed to Protect Against Evolving SARS-CoV-2 Variants
ATLANTA, GA, September 11, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that it has met the enrollment target for its Phase 2 clinical trial evaluating GEO-CM04S1 as a booster for healthy patients who have previously received the Pfizer or Moderna mRNA vaccine (ClinicalTrials.gov Identifier: NCT04639466).
The study is designed to evaluate the safety profile and immunogenicity of two GEO-CM04S1 dose levels administered as a COVID-19 vaccine booster among healthy individuals previously vaccinated with one of the FDA approved SARS-CoV-2 mRNA vaccines. The immunological responses measured throughout the study will include both the level of neutralizing antibodies against SARS-CoV-2 variants of concern and specific T cell responses.
GEO-CM04S1 is a next-generation COVID-19 vaccine based on GeoVax’s MVA viral vector platform, which supports the presentation of multiple vaccine antigens to the immune system in a single dose. GEO-CM04S1 encodes for both the spike (S) and nucleocapsid (N) antigens of SARS-CoV-2 and is specifically designed to induce both antibody and T cell responses to those parts of the virus less likely to mutate over time. The more broadly functional engagement of the immune system is designed to protect against severe disease caused by continually emerging variants of COVID-19. Vaccines of this format should not require frequent and repeated modification or updating.
“We would like to thank everyone who partnered with us to complete this important clinical trial enrollment milestone, especially the study volunteers and research staff at our clinical sites in the United States,” said David Dodd, GeoVax Chairman and CEO. “We believe the unique properties of GEO-CM04S1 potentially offer a more robust, durable degree of protection than the current authorized COVID-19 vaccines, not only as a booster vaccine to the currently authorized mRNA vaccines, but as a primary vaccine for highly vulnerable immunocompromised patients.”
Additional Ongoing Trials of GEO-CM04S1
In addition to the booster vaccine trial for which patient enrollment was just completed, GEO-CM04S1 is being evaluated in two other Phase 2 clinical trials:
As a primary vaccine in immunocompromised patients (with hematologic cancers receiving cell transplants or CAR-T therapy). ClinicalTrials.gov Identifier: NCT04977024. A recent presentation of unpublished data from the open-label portion of the trial indicates that GEO-CM04S1 is highly immunogenic in these patients, inducing both antibody responses, including neutralizing antibodies, and T cell responses. These data support the progression of the Phase 2 clinical study, which includes a direct comparison to currently approved mRNA vaccines.
As a booster vaccine in immunocompromised patients with chronic lymphocytic leukemia (CLL), a recognized high-risk group for whom current mRNA vaccines and monoclonal antibody (MAb) therapies appear inadequate relative to providing protective immunity. ClinicalTrials.gov Identifier: NCT05672355.
Further underscoring the need for next-generation COVID-19 vaccines such as GEO-CM04S1, GeoVax scientists co-authored an article titled, “MVA-Vectored Universal Beta-Coronavirus Vaccine Design & Development”, published in the June 2023 issue of the online journal Vaccine Insights. The article, accessible here, provides expert insight into the emergence of SARS-CoV-2 (COVID-19), the risk of new “spillover events” from animal hosts, and how this risk can be addressed proactively. Regarding COVID-19 and its continually evolving variants, the authors describe the limitations of first-generation vaccines and the potential for MVA-vectored vaccines such as GEO-CM04S1 to overcome these limitations.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
Record Full Year 2023 with $1,059 million of Revenue. 16.1% Revenue Growth over FY22 and 57.5% Revenue Growth over FY19
RICHMOND, Va.–(BUSINESS WIRE)– Bowlero Corp. (NYSE: BOWL) (“Bowlero” or the “Company”), the world’s largest owner and operator of bowling centers, today provided financial results for the fourth quarter and the full 2023 Fiscal Year, which ended on July 2, 2023. Fourth quarter 2022 and Fiscal Year 2022 had an extra week of results compared to Fourth quarter 2023 and Fiscal Year 2023.
Fourth Quarter Highlights:
Revenue was $239.4 million, down $28.3 million or (10.6)% from $267.7 million in the prior year, in which out-of-period Service Revenue and the 53rd week & related calendar shift totaled $29.7 million. Revenue was up 54.0% versus Fourth quarter Fiscal Year 2019
Total Bowling Center Revenue grew $5.4 million or 2.4% versus prior year and 54.1% versus Fourth quarter Fiscal Year 2019
Normalized Calendar Same Store Revenue decline of (2.6)% versus prior year and growth of 29.3% versus Fourth quarter Fiscal Year 2019
Net income of $146.2 million
Adjusted EBITDA of $64.5 million
Total centers in operation as of July 2, 2023 were 328
Fiscal Year 2023 Highlights:
Revenue was $1,058.8 million, up $147.1 million or 16.1% versus $911.7 million in the prior year, which included revenue from the 53rd week & related calendar shift totaling $20.7 million. Revenue was up 57.5% versus Fiscal Year 2019
Total Bowling Center Revenue grew $165.2 million or 19.4% versus prior year and 57.8% versus Fiscal Year 2019
Normalized Calendar Same Store Revenue growth of 12.8% versus prior year and 31.9% versus Fiscal Year 2019
Net income of $82.0 million
Adjusted EBITDA of $354.3 million
16 new centers added to the portfolio
“We finished Fiscal Year 2023 with 16% growth over Fiscal Year 2022 and 58% over Fiscal Year 2019. The same-store comp against a strong fourth quarter in Fiscal 2022 was down low-single digits in one of our seasonally smallest quarters. While April began with a decline versus the prior year, we saw an improving trend over the course of the quarter in conjunction with innovating our offerings to encourage more retail spend in our centers. We are in the early stages of pioneering new ways to increase wallet share from our vast customer base, and these changes are resonating with our guests,” said Tom Shannon, Founder, Chief Executive Officer and President. “The capital deployment opportunities are significant. Fiscal Year 2024 will be an investment year to drive top and bottom line growth. We remain confident in the upcoming fiscal year in which we have several exciting initiatives underway, including the acquisition of Lucky Strike, a robust M&A pipeline, new build activity in marquee markets, accelerated center conversions, and the continued rollout of initiatives to enhance the customer experience and increase wallet share. Additionally, as we anniversary the second year of our go-public transaction and 27th since our first center acquisition, we are excited to provide Fiscal Year 2024 guidance.”
Remediation of Material Weaknesses
In our Fiscal Year 2022 Form 10-K, material weaknesses were identified in controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, related to certain financial reporting processes. Throughout fiscal year 2023, management implemented measures designed to remediate the identified material weaknesses. Management has determined that the material weaknesses identified in the prior year have been remediated as of July 2, 2023.
Share Repurchase Program
During the quarter, the Company repurchased 6.4 million shares of Class A common stock at an average price of $12.64, bringing the total shares acquired under the program to 11.3 million and the average purchase price to $11.90. Pro forma for additional Class A common stock repurchased subsequent to quarter end, the total Class A and Class B shares outstanding as of August 30, 2023 are 160.2 million. On September 6, 2023, the Board authorized an increase to the share repurchase program to $200 million.
Fiscal Year 2024 Guidance
Today, the Company provided financial guidance for fiscal year 2024. We expect Revenue to be up 10% to 15% excluding the $21 million of Service Revenue, which equates to $1.14 billion to $1.19 billion of Revenue. Adjusted EBITDA margin is expected to be 32% to 34%, which equates to Adjusted EBITDA of $365 million to $405 million. We expect to heavily reinvest in the business in fiscal year 2024, with more than $160 million allocated to acquisitions, $40 million to new builds, and $75 million to conversions.
Investor Webcast Information
Listeners may access an investor webcast hosted by Bowlero. The webcast and results presentation will be accessible at 10:00 AM ET on September 11, 2023 in the Events & Presentations section of the Bowlero Investor Relations website at https://ir.bowlerocorp.com/overview/default.aspx.
About Bowlero Corp.
Bowlero Corp. is the worldwide leader in bowling entertainment. With 328 bowling centers across North America, Bowlero Corp. serves nearly 30 million guests each year through a family of brands that includes Bowlero and AMF. Bowlero Corp. is also home to the Professional Bowlers Association, which boasts thousands of members and millions of fans across the globe. For more information on Bowlero Corp., please visit BowleroCorp.com.
Forward Looking Statements
Some of the statements contained in this press release are 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, that involve risk, assumptions and uncertainties, such as statements of our plans, objectives, expectations, intentions and forecasts. These forward-looking statements are generally identified by the use of forward-looking terminology, including the terms “anticipate,” “believe,” “confident,” “continue,” “could,” “estimate,” “expect,” “intend,” “likely,” “may,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and, in each case, their negative or other various or comparable terminology. These forward-looking statements reflect our views with respect to future events as of the date of this release and are based on our management’s current expectations, estimates, forecasts, projections, assumptions, beliefs and information. Although management believes that the expectations reflected in these forward-looking statements are reasonable, it can give no assurance that these expectations will prove to have been correct. All such forward-looking statements are subject to risks and uncertainties, many of which are outside of our control, and could cause future events or results to be materially different from those stated or implied in this document. It is not possible to predict or identify all such risks. These risks include, but are not limited to: our ability to design and execute our business strategy; changes in consumer preferences and buying patterns; our ability to compete in our markets; the occurrence of unfavorable publicity; risks associated with long-term non-cancellable leases for our centers; our ability to retain key managers; risks associated with our substantial indebtedness and limitations on future sources of liquidity; our ability to carry out our expansion plans; our ability to successfully defend litigation brought against us; our ability to adequately obtain, maintain, protect and enforce our intellectual property and proprietary rights and claims of intellectual property and proprietary right infringement, misappropriation or other violation by competitors and third parties; failure to hire and retain qualified employees and personnel; the cost and availability of commodities and other products we need to operate our business; cybersecurity breaches, cyber-attacks and other interruptions to our and our third-party service providers’ technological and physical infrastructures; catastrophic events, including war, terrorism and other conflicts; public health emergencies and pandemics, such as COVID-19 pandemic, or natural catastrophes and accidents; changes in the regulatory atmosphere and related private sector initiatives; fluctuations in our operating results; economic conditions, including the impact of increasing interest rates, inflation and recession; and other factors described under the section titled “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (the “SEC”) by the Company on September 11, 2023, as well as other filings that the Company will make, or has made, with the SEC, such as Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this press release and in other filings. We expressly disclaim any obligation to publicly update or review any forward-looking statements, whether as a result of new information, future developments or otherwise, except as required by applicable law.
Non-GAAP Financial Measures
To provide investors with information in addition to our results as determined under Generally Accepted Accounting Principles (“GAAP”), we disclose Total Bowling Center Revenue, Normalized Calendar Same Store Revenue and Adjusted EBITDA as “non-GAAP measures”, which management believes provide useful information to investors because each measure assists both investors and management in analyzing and benchmarking the performance and value of our business. Accordingly, management believes that these measurements are useful for comparing general operating performance from period to period, and management relies on these measures for planning and forecasting of future periods. Additionally, these measures allow management to compare our results with those of other companies that have different financing and capital structures. These measures are not financial measures calculated in accordance with GAAP and should not be considered as a substitute for revenue, net income, or any other operating performance or liquidity measure calculated in accordance with GAAP, and may not be comparable to a similarly titled measure reported by other companies.
Total Bowling Center Revenue represents Total Revenue less Non-Center Related Revenue, Revenue from Closed Centers (as defined below), Service Revenue, and Revenue from the 53rd Week and associated Calendar Shift, if applicable. Normalized Calendar Same Store Revenue represents Total Revenue less Non-Center Related Revenue, Revenue from Closed Centers, Service Revenue, Revenue from the 53rd Week and associated Calendar Shift, if applicable, and Acquired Revenue. Adjusted EBITDA represents Net Income (Loss) before Interest, Income Taxes, Depreciation and Amortization, Share-based Compensation, EBITDA from Closed Centers, Foreign Currency Exchange Loss (Gain), Asset Disposition Loss (Gain), Transactional and other advisory costs, changes in the value of earnouts and warrants and settlement costs, and other.
The Company considers Total Bowling Center Revenue as an important financial measure because it provides a financial measure of revenue directly associated with bowling center operations. The Company also considers Normalized Calendar Same Store Revenue as an important financial measure because it provides comparable revenue for centers open for the entire duration of both the current and comparable measurement periods, and removes the impact of the 53rd week and associated calendar shift that are non-recurring in nature.
The Company considers Adjusted EBITDA as an important financial measure because it provides a financial measure of the quality of the Company’s earnings. Other companies may calculate Adjusted EBITDA differently than we do, which might limit its usefulness as a comparative measure. Adjusted EBITDA is used by management in addition to and in conjunction with the results presented in accordance with GAAP. We have presented Adjusted EBITDA solely as a supplemental disclosure because we believe it allows for a more complete analysis of results of operations and assists investors and analysts in comparing our operating performance across reporting periods on a consistent basis by excluding items that we do not believe are indicative of our core operating performance. Adjusted EBITDA has limitations as an analytical tool, and you should not consider it in isolation or as a substitute for analysis of our results as reported under GAAP. Some of these limitations are that Adjusted EBITDA:
do not reflect every expenditure, future requirements for capital expenditures or contractual commitments;
do not reflect changes in our working capital needs;
do not reflect the interest expense, or the amounts necessary to service interest or principal payments, on our outstanding debt;
do not reflect income tax (benefit) expense, and because the payment of taxes is part of our operations, tax expense is a necessary element of our costs and ability to operate;
do not reflect non-cash equity compensation, which will remain a key element of our overall equity based compensation package; and
do not reflect the impact of earnings or charges resulting from matters we consider not to be indicative of our ongoing operations.
GAAP Financial Information
Bowlero Corp.
Condensed Consolidated Balance Sheets
(Amounts in thousands, except share and per share amounts)
(Unaudited)
July 2, 2023
July 3, 2022
Assets
Current assets:
Cash and cash equivalents
$
195,633
$
132,236
Accounts and notes receivable, net of allowance for doubtful accounts of $551 and $504, respectively
3,092
5,227
Inventories, net
11,470
10,310
Prepaid expenses and other current assets
18,395
12,732
Assets held-for-sale
2,069
8,789
Total current assets
230,659
169,294
Property and equipment, net
697,850
534,721
Internal use software, net
17,914
11,423
Property and equipment under capital leases, net
—
262,703
Operating lease right of use assets, net
449,085
—
Finance lease right of use assets, net
515,339
—
Intangible assets, net
90,986
92,593
Goodwill
753,538
742,669
Deferred income tax asset
73,807
—
Other assets
12,096
41,022
Total assets
$
2,841,274
$
1,854,425
Liabilities, Temporary Equity and Stockholders’ Equity (Deficit)
Current liabilities:
Accounts payable and accrued expenses
$
121,226
$
101,071
Current maturities of long-term debt
9,338
4,966
Current obligations of operating lease liabilities
23,866
—
Other current liabilities
14,281
13,123
Total current liabilities
168,711
119,160
Long-term debt, net
1,138,687
865,090
Long-term obligations under capital leases
—
397,603
Long-term obligations of operating lease liabilities
431,295
—
Long-term obligations of financing lease liabilities
652,450
—
Earnout liability
112,041
210,952
Other long-term liabilities
34,380
54,418
Deferred income tax liabilities
4,160
14,882
Total liabilities
2,541,724
1,662,105
Commitments and Contingencies
Temporary Equity
Series A preferred stock
$
144,329
$
206,002
Stockholders’ Equity (Deficit)
Class A common stock
11
11
Class B common stock
6
6
Additional paid-in capital
506,112
335,015
Treasury stock, at cost
(135,401
)
(34,557
)
Accumulated deficit
(219,659
)
(312,851
)
Accumulated other comprehensive income (loss)
4,152
(1,306
)
Total stockholders’ equity (deficit)
155,221
(13,682
)
Total liabilities, temporary equity and stockholders’ equity (deficit)
$
2,841,274
$
1,854,425
Bowlero Corp.
Condensed Consolidated Statements of Operations
(Amounts in thousands)
(Unaudited)
Three Months Ended
Twelve Months Ended
July 2,2023
July 3,2022
July 2,2023
July 3,2022
Revenues
$
239,420
$
267,717
$
1,058,790
$
911,705
Costs of revenues
182,172
185,229
716,384
609,971
Gross profit
57,248
82,488
342,406
301,734
Operating (income) expenses:
Selling, general and administrative expenses
35,082
35,689
137,919
180,702
Asset impairment
1,028
1,548
1,601
1,548
Gain on sale of assets
(70
)
(2,354
)
(2,240
)
(4,109
)
Other operating expense
1,701
1,260
4,326
6,968
Total operating expense
37,741
36,143
141,606
185,109
Operating profit
19,507
46,345
200,800
116,625
Other expenses (income):
Interest expense, net
30,785
25,359
110,851
94,460
Change in fair value of earnout liability
(73,406
)
2,564
85,352
25,800
Change in fair value of warrant liability
—
6,092
—
26,840
Other expense
1,436
(12
)
6,792
149
Total other (income) expense
(41,185
)
34,003
202,995
147,249
Income (loss) before income tax benefit
60,692
12,342
(2,195
)
(30,624
)
Income tax (benefit) Expense
(85,528
)
5,399
(84,243
)
(690
)
Net income (loss)
146,220
6,943
82,048
(29,934
)
Bowlero Corp.
Condensed Consolidated Statements of Cash Flows
(Amounts in thousands)
(Unaudited)
Three Months Ended
Twelve Months Ended
July 2,2023
July 3,2022
July 2,2023
July 3,2022
Net cash provided by operating activities
$
8,985
$
34,809
$
217,787
$
177,670
Net cash used in investing activities
(65,269
)
(41,601
)
(253,218
)
(220,345
)
Net cash provided by (used in) financing activities
90,993
(33,888
)
98,957
(12,136
)
Effect of exchange rate changes on cash
(120
)
(61
)
(129
)
(46
)
Net increase (decrease) in cash, cash equivalents and restricted cash
34,589
(40,741
)
63,397
(54,857
)
Cash, cash equivalents and restricted cash at beginning of period
161,044
172,977
132,236
187,093
Cash, cash equivalents and restricted cash at end of period
$
195,633
$
132,236
$
195,633
$
132,236
GAAP to non-GAAP Reconciliations
Same Store Reconciliation – FY23 vs. FY19
Same Store Reconciliation – FY23 vs. FY22
(in thousands)
4Q FY19
4Q FY23
FY19
FY23
4Q FY22
4Q FY23
FY22
FY23
Total Revenue – Reported
$
155,494
$
239,420
$
672,175
$
1,058,790
$
267,717
$
239,420
$
911,705
$
1,058,790
less: Non-Center Related
(including Closed Centers)
(6,344
)
(5,545
)
(28,387
)
(21,613
)
(7,868
)
(5,545
)
(25,287
)
(21,613
)
less: Service Revenue
—
(4,088
)
—
(21,019
)
(14,796
)
(4,088
)
(14,796
)
(21,019
)
less: 53rd Week / Calendar Shift
—
—
—
—
(20,663
)
—
(20,663
)
—
Total Bowling Center Revenue
$
149,150
$
229,787
$
643,788
$
1,016,158
$
224,390
$
229,787
$
850,959
$
1,016,158
less: Acquired Revenue
(1,382
)
(38,729
)
(17,419
)
(189,715
)
(168
)
(11,406
)
(47,168
)
(109,737
)
Normalized Calendar Same Store Revenue
$
147,768
$
191,058
$
626,369
$
826,443
$
224,222
$
218,381
$
803,791
$
906,421
% Year-over-Year Change
Total Revenue – Reported
54.0
%
57.5
%
(10.6
)%
16.1
%
Total Bowling Center Revenue
54.1
%
57.8
%
2.4
%
19.4
%
Normalized Calendar Same Store Revenue
29.3
%
31.9
%
(2.6
)%
12.8
%
Adjusted EBITDA Reconciliation
Three Months Ended
Twelve Months Ended
(in thousands)
July 2, 2023
July 3, 2022
July 2, 2023
July 3, 2022
Consolidated
Revenue
$239,420
$267,717
$1,058,790
$911,705
Net income (loss) – GAAP
$146,220
$6,943
$82,048
$(29,934)
Net income (loss) margin
61.1%
2.6%
7.7%
(3.3)%
Adjustments:
Interest expense
32,095
25,359
112,160
94,460
Income tax (benefit) expense
(85,528)
5,399
(84,243)
(690)
Depreciation, amortization and impairment charges
31,693
30,018
117,281
108,505
Share-based compensation
3,851
3,860
15,742
50,236
Closed center EBITDA (1)
1,692
51
3,319
1,480
Foreign currency exchange (gain) loss
(128)
(26)
(53)
5
Asset disposition gain
(70)
(2,355)
(2,240)
(4,109)
Transactional and other advisory costs (2)
6,804
2,762
23,635
43,512
Changes in the value of earnouts and warrants (3)
(73,406)
8,644
85,352
52,789
Other, net (4)
1,270
1,737
1,343
121
Adjusted EBITDA
$64,493
$82,392
$354,344
$316,375
Adjusted EBITDA Margin
26.9%
30.8%
33.5%
34.7%
(1)
The closed center adjustment is to remove EBITDA for closed centers. Closed centers are those centers that are closed for a variety of reasons, including permanent closure, newly acquired or built centers prior to opening, centers closed for renovation or rebranding and conversion. If a center is not open on the last day of the reporting period, it will be considered closed for that reporting period. If the center is closed on the first day of the reporting period for permanent closure, the center will be considered closed for that reporting period.
(2)
The adjustment for transaction costs and other advisory costs is to remove charges incurred in connection with any transaction, including mergers, acquisitions, refinancing, amendment or modification to indebtedness, dispositions and costs in connection with an initial public offering, in each case, regardless of whether consummated.
(3)
The adjustment for changes in the value of earnouts and warrants is to remove of the impact of the revaluation of the earnouts and warrants. As a result of the Business Combination, the Company recorded liabilities for earnouts and warrants. Changes in the fair value of the earnout and warrant liabilities are recognized in the statement of operations. Decreases in the liability will have a favorable impact on the statement of operations and increases in the liability will have an unfavorable impact. The adjustment also includes realized costs associated with the settlement of warrants during past reporting periods.
(4)
Other includes the following related to transactions that do not represent ongoing or frequently recurring activities as part of the Company’s operations: (i) non-routine expenses, net of recoveries for matters outside the normal course of business and (ii) other individually de minimis expenses. Certain prior year amounts have been reclassified to conform to current year presentation.
Leaders with Johnson Controls, Kaiser Permanente, LTIMindtree, McKesson and the National Renewable Energy Laboratory named winners in five award categories
STAMFORD, Conn.–(BUSINESS WIRE)– Information Services Group (ISG) (Nasdaq: III), a leading global technology research and advisory firm, today announced the winners of the second annual ISG Women in Digital Awards program for the Americas, recognizing women and their achievements in the digital world.
At a live, virtual award ceremony the evening of September 7, leaders with Johnson Controls, Kaiser Permanente, LTIMindtree, McKesson and the National Renewable Energy Laboratory were honored as winners in five categories, as selected by a panel of industry judges.
“The ISG Women in Digital Awards program received an overwhelming response in our second year, reflecting the large and growing pool of talented women in digital roles,” said Lois Coatney, ISG partner and president, and executive sponsor of the ISG Women in Digital program. “The women chosen as winners have made impressive, impactful and important contributions to the digital industry as a whole. We celebrate their accomplishments.”
An independent panel of judges, comprised of Nidhi Alexander, chief marketing officer, Hexaware; Shannon Bjerregaard, senior vice president and CIO of medical surgical at McKesson; Chris Putur, retired CIO of REI and member of the board of directors of ISG and RealTruck; Sarah Urbanowicz, senior vice president and CIO, AECOM, and Mary Rivard, partner, ISG technology modernization, evaluated the nominations and selected the following winners:
Rising Star: for demonstrating exceptional and continuous growth, with increasing levels of leadership, responsibility and sphere of impact: Gold Winner: Melissa Rojo Salazar, U.S. senior director of consulting, co-lead of product services and innovation, LTIMindtree Silver Winner: Bernice Wong, senior design manager, Albertsons Bronze Winner: Devon Reilly, senior business process lead, PVH Corp.
Women’s Advocate: for playing an active role guiding women to succeed in the digital world: Gold Winner: Diane Schwarz, vice president and CIO, Johnson Controls Silver Winner: Shatabdi Sharma, vice president, Global Application Services, PVH Corp. Bronze Winner: Heather Bunyard, customer success officer, Birlasoft
Digital Innovator: for making a significant impact on an organization, business or client through creative use of digital solutions: Gold Winner: Bridget Karlin, senior vice president of IT, Kaiser Permanente Silver Winner: Richa Agarwal, senior director of digital go-to-market, PVH Corp. Bronze Winner: Ellen Trager, chief digital and information officer, Carrier
Rock Star Leader: for leading a major transformation with significant business impact and demonstrating exceptional leadership skills: Gold Winner: Nancy Avila, executive vice president, chief information officer and chief technology officer, McKesson Silver Winner: Sruti Patnaik, chief information officer, Camping World Bronze Winner: Giao Carrico, senior partner, consulting practice leader for data technology and AI, Genpact
Dr. Annabelle Pratt, principal engineer, National Renewable Energy Laboratory, was chosen by the judges as the Digital Titan of the Year for the Americas from the entire pool of regional nominees, recognizing her as the most outstanding woman in digital for 2023.
The awards program, launched in the Americas in 2022, was expanded for 2023 to the Europe, Middle East and Africa (EMEA) and Asia Pacific regions, including India. The global program received a total of 327 nominees, who are listed in an online ISG Women in Digital eBook. Awards for Asia Pacific and India will be presented October 11, at 6 p.m., AEDT, and awards for EMEA will be presented October 26, at 6 p.m., GMT.
“Women are breaking barriers and making lasting, positive changes in digital and technology leadership roles,” said Kimberly Tobias, ISG director and head of the ISG Women in Digital program. “We are delighted to recognize the success of each person nominated and to offer our sincere congratulations to our 2023 winners.”
Created in 2018, the ISG Women in Digital community provides a platform to exchange practical advice and innovative ideas on diversity and advancement in the workplace. The community hosts a LinkedIn page, an ongoing ISG Digital Dish podcast series, and regular events for ISG employees and the greater IT and business services industry.
For more information about the ISG Women in Digital Awards, contact ISG.
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.
MALVERN, Pa., Sept. 07, 2023 (GLOBE NEWSWIRE) — Baudax Bio, Inc. (the “Company” or “Baudax Bio”) (NASDAQ: BXRX), a biotechnology company focused on developing T cell receptor (“TCR”) therapies utilizing human regulatory T cells (“Tregs”), as well as a portfolio of clinical stage Neuromuscular Blocking Agents (“NMBs”) and an associated reversal agent, today announced that that the Company’s management will be participating in the 25th Annual H.C. Wainwright Global Investment Conference, to be held September 11-13, 2023 in New York, NY.
Gerri Henwood, President & Chief Executive Officer of Baudax Bio, will give a pre-recorded presentation highlighting the Company’s cellular therapy programs, which will be available on-demand by clicking here for the duration of the conference. Ms. Henwood will also be available for one-on-one meetings.
About Baudax Bio
Baudax Bio/TeraImmune is a biotech company focused on innovative products for certain auto-immune conditions, of which many but not all, are orphan drug conditions as well as acute care and related settings. The combined company will further the development of Treg therapy specific to HA (pipeline candidate TI-168). TI-168 is a next-generation, FVIII specific Treg therapy designed to reliably and effectively address Hemophilia A patients with FVIII inhibitor. By combining the patented Treg culture method and TeraImmune designed FVIII-specific TCR, the Company has successfully demonstrated the therapeutic concept of FVIII TCR-Treg therapy in controlling of FVIII ADA in a hemophilic animal model. The lead program TI-168 has shown encouraging pre-clinical data and the FDA has cleared an IND to commence a Phase 1/2a clinical trial for the treatment of Hemophilia A with inhibition.
In addition, over time, the combined company will advance the development of TeraImmune’s innovative immune-cell therapies, leveraging a dual Treg manufacturing platform consisting of both natural regulatory Tregs isolated from patients and induced Tregs converted from a patient’s T-effector (“Teff”) cells. This Treg platform technology is designed for conditions that suppress unwanted immune reactions and includes the allogenic, or off-the-shelf, Tregs obtained from Umbilical Cord Blood for the treatment of skin diseases such as Atopic Dermatitis. For more information, please visit www.baudaxbio.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements reflect Baudax Bio’s expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words “anticipate,” “believe,” “estimate,” “may,” “upcoming,” “plan,” “target,” “goal,” “intend,” and “expect,” and similar expressions, as they relate to Baudax Bio, are intended to identify such forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Baudax Bio’s current beliefs, expectations and assumptions regarding the future of its business, future plans and strategies, clinical results and other future conditions. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption “Risk Factors” in Baudax Bio’s most recent Annual Report on Form 10-K filed with the SEC and its subsequent filings with the SEC. Any forward looking statement speaks only as of the date on which it was made. Neither Baudax Bio, nor any of its affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing Baudax Bio’s views as of any date subsequent to the date hereof.
