FORT WAYNE, Ind., Feb. 08, 2024 (GLOBE NEWSWIRE) — Vera Bradley, Inc. (Nasdaq: VRA) (the “Company”) today announced that it plans to report results for the fourth quarter and fiscal year ended February 3, 2024 at 8:00 a.m. Eastern Time on Wednesday, March 13, 2024.
The Company will host a conference call to discuss its financial results at 9:30 a.m. Eastern Time that same day. A live webcast of the conference call will be available on the Investor Relations section of the Company’s website, www.verabradley.com. Alternatively, interested parties may dial into the call at (877) 407-0779, and enter the access code 13742953. A replay will be available shortly after the conclusion of the call and remain available through March 27, 2024. To access the recording, listeners should dial (844) 512-2921, and enter the access code 13742953.
ABOUT VERA BRADLEY, INC.
Vera Bradley, Inc. operates two unique lifestyle brands – Vera Bradley and Pura Vida. Vera Bradley and Pura Vida are complementary businesses, both with devoted, emotionally connected, and multi-generational female customer bases; alignment as causal, comfortable, affordable, and fun brands; positioning as “gifting” and socially-connected brands; strong, entrepreneurial cultures; a keen focus on community, charity, and social consciousness; multi-channel distribution strategies; and talented leadership teams aligned and committed to the long-term success of their brands.
Vera Bradley, based in Fort Wayne, Indiana, is a leading designer of women’s handbags, luggage and other travel items, fashion and home accessories, and unique gifts. Founded in 1982 by friends Barbara Bradley Baekgaard and Patricia R. Miller, the brand is known for its innovative designs, iconic patterns, and brilliant colors that inspire and connect women unlike any other brand in the global marketplace.
In July 2019, Vera Bradley, Inc. acquired a 75% interest in Creative Genius, Inc., which also operates under the name Pura Vida Bracelets (“Pura Vida”). Pura Vida, based in La Jolla, California, is a digitally native, highly engaging lifestyle brand founded in 2010 by friends Paul Goodman and Griffin Thall. Pura Vida has a differentiated and expanding offering of bracelets, jewelry, and other lifestyle accessories. The Company acquired the remaining 25% of Pura Vida in January 2023.
PONTE VEDRA, Fla., Feb. 8, 2024 — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin, a novel Vitamin K Antagonist (VKA) for unmet needs in anticoagulation (blood thinning) therapy, today announced the appointment of Jeff Cole to the newly created position of Chief Operating Officer. In this role, Mr. Cole will be responsible for the Company’s manufacturing and supply chain operations, intellectual property, commercialization strategies, and supporting partnering activities for tecarfarin.
Mr. Cole brings over 25 years of experience in global pharmaceutical manufacturing and commercial operations, finance, and corporate development to the Company. This includes senior executive roles at both private and publicly-traded companies such as Espero BioPharma, Valeant Pharmaceuticals International (now Bausch Health Companies), and Legacy Pharmaceuticals. Mr. Cole co-founded Espero, a biopharmaceutical company focusing on the late-stage development and commercialization of medicines to treat cardiovascular diseases, and served as Board Director, President, and Chief Financial Officer where he was responsible for the company’s supply chain, commercialization, and multiple licensing and M&A transactions.
“Jeff is an extremely accomplished pharmaceutical operations executive with a deep understanding of product development, manufacturing, and commercialization. His experience will serve Cadrenal well as we advance our tecarfarin clinical program and evaluate partnering opportunities,” commented Quang Pham, Founder, Chairman and Chief Executive Officer of Cadrenal Therapeutics.
While at Valeant, Mr. Cole held roles of increasing responsibility, including as General Manager, Vice President of Corporate Development, and Chief Financial Officer of North America, where revenue more than tripled during his tenure. As General Manager at Valeant, Mr. Cole managed a division of U.S. prescription and OTC products across multiple therapeutic areas with responsibility for product development, supply, and commercial operations. Prior to the pharmaceutical industry, Mr. Cole served as Principal in the Financial Management Consulting practice at PricewaterhouseCoopers.
“I am excited to be joining the team at Cadrenal at a pivotal time when demand is increasing for a new anticoagulation therapy to address the unmet needs for patients with left ventricular assist devices (LVADs), antiphospholipid syndrome (APS), and those with end-stage kidney disease (ESKD) and atrial fibrillation (AFib),” added Jeff Cole. “I look forward to leveraging my experience to advance tecarfarin to the market and help those underserved patient groups.”
Mr. Cole holds an MBA with honors from the University of Michigan and a BS in accounting from the University of Southern California.
ABOUT CADRENAL THERAPEUTICS, INC.
Cadrenal Therapeutics is developing tecarfarin for unmet needs in anticoagulation therapy. Tecarfarin is a late-stage novel oral and reversible anticoagulant (blood thinner) to prevent heart attacks, strokes, and deaths due to blood clots in patients with certain medical conditions. Tecarfarin has orphan drug and fast track designations from the FDA for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib). Cadrenal is also pursuing additional regulatory strategies for unmet needs in anticoagulation therapy for patients with left ventricular assist devices (LVADs) and those with thrombotic antiphospholipid syndrome (APS). Tecarfarin is specifically designed to leverage a different metabolism pathway than the oldest and most commonly prescribed Vitamin K Antagonist (warfarin). Tecarfarin has been evaluated in eleven (11) human clinical trials and more than 1,000 individuals. In Phase 1, Phase 2, and Phase 2/3 clinical trials, tecarfarin has generally been well-tolerated in both healthy adult subjects and patients with chronic kidney disease. For more information, please visit: www.cadrenal.com.
Safe Harbor Statement
Any statements contained in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include statements regarding the Mr. Cole’s experience serving the Company well as it advances its tecarfarin clinical program and evaluates partnering opportunities and leveraging Mr. Cole’s experience to advance tecarfarin to the market and help underserved patient groups. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the expected contribution from Mr. Cole and the ability to advance tecarfarin with patients with left ventricular assist devices (LVADs), thrombotic APS, and those with AFib and ESKD and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, and the Company’s subsequent filings with the SEC, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.
For more information, please contact:
Cadrenal Therapeutics: Matthew Szot, CFO 858-337-0766 press@cadrenal.com
Investors: Lytham Partners, LLC Robert Blum, Managing Partner 602-889-9700 CVKD@lythampartners.com
CULVER CITY, Calif., Feb. 08, 2024 (GLOBE NEWSWIRE) — Snail, Inc. (Nasdaq: SNAL) (“Snail” or “the Company”), a leading, global independent developer and publisher of interactive digital entertainment today announced the introduction of game-changing updates to ARK: Survival Ascended’s dev kit, setting the stage for an influx of creativity and customization within the ARK universe.
ARK Survival Ascended’s “Custom Cosmetic” system is a feature that takes player expression to new levels. This innovative update empowers players to apply user-generated costumes to characters and dinosaurs, while also enabling the creation of skins for armor, weapons and all the game’s structures. Beyond the aesthetic appeal, this system introduces new functionalities, including network messaging and limited persistent replicated data storage. The introduction of this system allows for visual variety and functional enhancement through player-created cosmetics, all achieved seamlessly without the need for server updates or loading onto a server. In early February 2024, phase 1 of the system will be activated, allowing players to manually install Custom Cosmetic Mods, unlocking a realm of creative expression on Official Servers. Ultimately, Custom Cosmetic Mods will be automatically downloaded in the background when encountered during gameplay; this automatic download feature is set to go live Q2 2024.
As a glimpse into the creative potential of the dev kit update, Snail Games, Studio Wild Card, and OverWolf offered a sneak peek into “Super ARK Bros,” a two-player side-scroller example mod set to be released early February. This work-in-progress showcases a simple game framework, independent of ARK: Survival Ascended’s gameplay code. This serves as an example of how creators will be able to utilize Unreal Engine 5 to craft their own unique games, with the freedom to make as many or as few changes as they desire, all of which can be released on ARK Survival Ascended.
But that’s not all. In celebration of love, Snail Games is delighted to announce that this year’s “Love Evolved” Valentine’s Day event, will become a permanent fixture as a mod within ARK: Survival Ascended. Survivors can feel the love in the air whenever they desire!
“These updates mark a pivotal moment in the evolution of ARK: Survival Ascended,” says Jim Tsai, Chief Executive Officer of Snail, Inc. “The introduction of the Custom Cosmetic system and the simple game framework on the ARK SDK represent our unwavering commitment to providing continuous support to our modding community. We can’t wait to witness the incredible creations our community will bring to life.”
Snail Games invites players to embrace these transformative changes and anticipates a dynamic and vibrant future for user generated content in ARK: Survival Ascended.
About Snail, Inc.
Snail is a leading, global independent developer and publisher of interactive digital entertainment for consumers around the world, with a premier portfolio of premium games designed for use on a variety of platforms, including consoles, PCs and mobile devices.
Forward-Looking Statements
This press release contains statements that constitute forward-looking statements. Many of the forward-looking statements contained in this press release can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “may,” “predict,” “continue,” “estimate” and “potential,” or the negative of these terms or other similar expressions. Forward-looking statements appear in a number of places in this press release and include, but are not limited to, statements regarding Snail’s intent, belief or current expectations. These forward-looking statements include information about possible or assumed future results of Snail’s business, financial condition, results of operations, liquidity, plans and objectives. The statements Snail makes regarding the following matters are forward-looking by their nature: growth prospects and strategies; launching new games and additional functionality to games that are commercially successful, including the launch of ARK: Survival Ascended, ARK: The Animated Series and ARK 2; expectations regarding significant drivers of future growth; its ability to retain and increase its player base and develop new video games and enhance existing games; competition from companies in a number of industries, including other game developers and publishers and both large and small, public and private Internet companies; its relationships with third-party platforms such as Xbox Live and Game Pass, PlayStation Network, Steam, Epic Games Store, the Apple App Store, the Google Play Store, My Nintendo Store and the Amazon Appstore; expectations for future growth and performance; and assumptions underlying any of the foregoing.
TORONTO, Feb. 08, 2024 (GLOBE NEWSWIRE) — Labrador Gold Corp. (TSX.V:LAB | OTCQX:NKOSF | FNR: 2N6) (“LabGold” or the “Company”) is pleased to announce the results of the 2023 exploration program at its 100% owned Hopedale Project in Labrador. The district scale Hopedale property covers a 43km strike length of the Florence Lake greenstone belt which has characteristics typical of greenstone belts around the world but has been underexplored by comparison.
Highlights
Fire Ant gold occurrence
high-grade gold up to 106g/t with 20.4g/t Ag in rock grab samples
mineralization traced over approximately 200 metres strike length
Rusty Ridge and Last Resort nickel occurrences
anomalous Ni area at Rusty Ridge extended to 550m
rock samples up to 0.28% Ni and soil samples up to 0.23% Ni
Identified a new anomalous nickel area (Last Resort) over a strike length of 1.6km coincident with a significant magnetic high
Jasmine zinc occurrence
anomalous zinc zone identified over 400m at Jasmine with values up to 0.97% Zn in rock and 0.22% in soil
Jasmine also shows high copper and gold values indicating potential for volcanogenic style mineralization
Thurber Boundary copper occurrence
highest copper in soil value (3,493 ppm) found on the property to date identified in a 400m anomalous trend
Eight occurrences identified on the Hopedale project to date reflecting multiple mineralization styles including orogenic gold, magmatic Ni sulphide, copper-silver vein and Zn-rich volcanogenic massive sulphide
Significant gold and silver in rock grab samples was found in the Rusty Ridge area with a high of 106g/t Au and 20.4 g/t Ag, 3.7g/t Au and 4.9g/t Ag and 2.9g/t Au and 4.7g/t Ag. This newly discovered mineralization named the Fire Ant occurrence, is hosted in gossanous felsic volcanic rocks close to the contact with ultramafic volcanic rocks and has been traced over a strike length of approximately 200 metres.
Work during 2022 found significant nickel anomalies in soil and rock at an area named Rusty Ridge. The anomalies occur in ultramafic rocks indicating potential for magmatic nickel style mineralization. One of the goals of the 2023 exploration program was to follow up and extend these anomalies. A total of 14 grab samples of rock assayed over 0.1% Ni and included values up to 0.28% Ni while nickel values in soil up to 2,271ppm (0.23%) show a significant northeast-southwest trend extending the anomalous area over 550m. Approximately 1.2km south of Rusty Ridge, anomalous nickel in soil samples was outlined over a 1.6km strike length and is coincident with a significant magnetic high. Six of the samples assayed over 1,000ppm (0.1%) Ni with a high of 2,271ppm (0.23%) Ni. Limited rock sampling showed assays of 0.28%, 0.17% and 0.16% Ni in grab samples in this area named Last Resort.
The highest copper value in soil (3,493ppm) on the property to date was recorded at Thurber Boundary, where it forms a northeast-southwest trend over approximately 500 metres. The location of the soil anomaly is in a similar stratigraphic location, close to the contact of mafic and ultramafic volcanic rocks, as the high grade (3.31% Cu over 0.76m and 1.55% Cu over 1m in channel samples) Kaapak copper occurrence approximately 3 kilometres to the south.
In addition to the copper, nickel and gold found during the exploration program, anomalous zinc was found in soil samples (up to 0.22%) and rock (up to 0.97%) in the Jasmine area. The anomalous zone extends over approximately 400 metres and is coincident with a contact highlighted by a change from magnetic high to magnetic low. The Jasmine area is also known to have high copper and gold values indicating potential for volcanogenic massive sulphide deposits.
“Our 2023 exploration program over the district scale Hopedale property confirmed the significant prospectivity of the Rusty Ridge area for nickel associated with ultramafic rocks and identified a new area, Last Resort, with similar potential for magmatic sulphide type mineralization,” said Roger Moss, President and CEO of Labrador Gold. “The highest grade gold found on the property to date, 106g/t Au and 20.4g/t Ag, was sampled at a new occurrence, Fire Ant, in the Rusty Ridge area and brings the number of significant gold occurrences on the property to five. Potential for zinc-rich volcanogenic massive sulphide was identified at Jasmine as well as a significant copper in soil anomaly at Thurber Boundary. Work conducted by LabGold at Hopedale demonstrates that the Florence Lake greenstone belt contains many of the same mineralization styles seen in some of the most productive greenstone belts elsewhere in the world.”
Figure 1. Location of the nickel, copper, gold and zinc occurrences on the Hopedale Property.
Figure 2. Highlights of nickel in soil and rock samples over Rusty Ridge and Last Resort Occurrences.
Figure 3. Location of high-grade gold mineralization at Fire Ant occurrence.
Table 1. Highlights of rock samples assays from 2023 exploration program. Note that grab samples are selective samples and may not be representative of the mineralization found on the property. n/a = not assayed.
QA/QC
Rock samples comprise grab samples, which are selective samples and not necessarily representative of mineralization found on the property. Samples were securely stored prior to shipping to analytical labs for assay. Rock samples were assayed at Eastern Analytical Laboratory in Springdale, an ISO/IEC17025 accredited laboratory for gold by standard 30g fire assay with atomic absorption finish as well as by ICP-OES for an additional 34 elements. Additional samples were sent to SGS Canada for whole rock assays by borate fusion XRF and ICP-MS/AES. Soil samples were submitted to SGS for gold by standard 30g fire assay with atomic absorption finish as well as ICP-MS for an additional 48 elements. The company submits blanks and certified reference standards amounting to 5% of each sample batch.
Qualified Person
Roger Moss, PhD., P.Geo., President and CEO of LabGold, a Qualified Person in accordance with Canadian regulatory requirements as set out in NI 43-101, has read and approved the scientific and technical information that forms the basis for the disclosure contained in this release.
The Company gratefully acknowledges the Newfoundland and Labrador Ministry of Natural Resources’ 2023 Junior Exploration Assistance (JEA) Program and the Atlantic Canada Opportunities Agency’s Critical Minerals Assistance for its financial support for exploration of the Hopedale property.
About Labrador Gold Labrador Gold is a Canadian based mineral exploration company focused on the acquisition and exploration of prospective gold projects in Eastern Canada.
Labrador Gold’s flagship property is the 100% owned Kingsway project in the Gander area of Newfoundland. The four licenses comprising the Kingsway project cover approximately 12km of the Appleton Fault Zone which is associated with numerous gold occurrences in the region. Infrastructure in the area is excellent located just 18km from the town of Gander with road access to the project, nearby electricity and abundant local water. LabGold is drilling a projected 100,000 metres targeting high-grade epizonal gold mineralization along the Appleton Fault Zone with encouraging results.
The Hopedale property covers much of the Florence Lake greenstone belt that stretches over 60 km. The belt is typical of greenstone belts around the world but has been underexplored by comparison. Work to date by Labrador Gold show gold anomalies in rocks, soils and lake sediments over a 3 kilometre section of the northern portion of the Florence Lake greenstone belt. Four gold occurrences lie along this trend, three of which Thurber North, TD500 and Thurber South were discovered by LabGold. Anomalous gold in soil and lake sediment samples also occur over approximately 40 km along the southern section of the greenstone belt. LabGold’s recent exploration has also demonstrated the potential for the critical metals copper, nickel and cobalt in the belt.
The Company has 170,009,979 common shares issued and outstanding and trades on the TSX Venture Exchange under the symbol LAB.
For more information please contact: Roger Moss, President and CEO Tel: 416-704-8291
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release .
Forward-Looking Statements: This news release contains forward-looking statements that involve risks and uncertainties, which may cause actual results to differ materially from the statements made. When used in this document, the words “may”, “would”, “could”, “will”, “intend”, “plan”, “anticipate”, “believe”, “estimate”, “expect” and similar expressions are intended to identify forward-looking statements. Such statements reflect our current views with respect to future events and are subject to risks and uncertainties. Many factors could cause our actual results to differ materially from the statements made, including those factors discussed in filings made by us with the Canadian securities regulatory authorities. Should one or more of these risks and uncertainties, such as actual results of current exploration programs, the general risks associated with the mining industry, the price of gold and other metals, currency and interest rate fluctuations, increased competition and general economic and market factors, occur or should assumptions underlying the forward looking statements prove incorrect, actual results may vary materially from those described herein as intended, planned, anticipated, or expected. We do not intend and do not assume any obligation to update these forward-looking statements, except as required by law. Shareholders are cautioned not to put undue reliance on such forward-looking statements .
Conference Call to be held Thursday, February 29 at 8:00 a.m. Central Time
HOUSTON, Feb. 08, 2024 (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 fourth quarter and full year ended December 31, 2023, on Wednesday, February 28, 2024, after the close of the stock market.
A conference call and audio webcast with analysts and investors will be held the next day, February 29, at 8:00 a.m. Central Time/9:00 a.m Eastern 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, Hawaii, 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 strategically located across its operating areas. (oriongroupholdingsinc.com)
Bitcoin Depot Plans to Install Bitcoin ATMs in Locations Across the US South
ATLANTA, Feb. 07, 2024 (GLOBE NEWSWIRE) — Bitcoin Depot Inc. (“Bitcoin Depot” or the “Company”) (NASDAQ: BTM), a U.S.-based Bitcoin ATM operator and leading fintech company, today announced a retail partnership with a leading operator of convenience stores in the U.S.
Bitcoin Depot plans to install its BTMs in an additional 63 stores across multiple metropolitan areas, strengthening Bitcoin Depot’s retail footprint. This partnership augments Bitcoin Depot’s comprehensive growth plan, which focuses on increasing its BTM network and continuing to build a robust pipeline of major regional and national retail partners. Last month, the Company announced an additional partnership that includes a deployment of nearly 1,000 BTMs nationally.
“This expansion aligns with our commitment to bringing Bitcoin to the masses,” said Bitcoin Depot CEO Brandon Mintz. “Our goal is to bring easy and convenient crypto access to a plethora of communities while creating unmatched value for our retail partners and welcoming new customers.”
This expansion allows Bitcoin Depot customers to purchase Bitcoin in easy and accessible c-store locations across the South where a variety of additional amenities are available. As part of the partnership, additional Bitcoin Depot’s kiosks will now be available in the following states including Alabama, Arkansas, Arizona, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Maine, Michigan, North Carolina, Mississippi, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, and West Virginia.
Bitcoin Depot’s products and services provide an intuitive, quick, and convenient process for converting cash into Bitcoin, giving users the ability to access the broader digital financial system by conveniently purchasing Bitcoin at Bitcoin ATMs in 48 states. In addition to Bitcoin ATMs, Bitcoin Depot also has BDCheckout enabled for customers to fund their wallets with cash at participating retail locations in 28 states nationwide.
About Bitcoin Depot Bitcoin Depot Inc. (Nasdaq: BTM) was founded in 2016 with the mission to connect those who prefer to use cash to the broader, digital financial system. Bitcoin Depot provides its users with simple, efficient and intuitive means of converting cash into Bitcoin, which users can deploy in the payments, spending and investing space. Users can convert cash to bitcoin at Bitcoin Depot kiosks in 48 states and at thousands of name-brand retail locations in 29 states through its BDCheckout product. The Company has the largest market share in North America with approximately 6,400 kiosk locations as of September 30, 2023. Learn more at www.bitcoindepot.com
Contacts:
Investors Cody Slach, Alex Kovtun Gateway Group 949-574-3860 btm@gateway-grp.com
Media Christina Lockwood, Brenlyn Motlagh, Ryan Deloney Gateway Group 949-574-3860 btm@gateway-grp.com
THIO treatment leads to profound activation of innate and adaptive anti-tumor responses
THIO depletes cancer initiating cells (CICs) and thus diminishes tumor initiation and metastasis-forming potential in various in vivo models
THIO previously awarded orphan drug designation (ODD) by FDA for small cell lung cancer (SCLC) treatment
CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced the publication of extensive work describing preclinical studies for lead candidate THIO in small cell lung cancer (SCLC) in the peer-reviewed scientific journal Nature Communications. The reported findings from the research, conducted in collaboration with the University of Texas Southwestern (UTSW) scientists, led by corresponding author Dr. Esra Akbay, demonstrate the immune-enhancing, metastasis-reducing effects of MAIA’s telomere-targeting agent THIO (6TdG) in several well-characterized in vitro and in vivo models of SCLC.
“This publication highlights a rather unique dual mechanism of action for THIO as a first-in-clinic telomere-targeted anticancer agent for potential treatment of SCLC,” said Sergei M. Gryaznov, PhD., MAIA’s Chief Scientific Officer. “In addition to the direct and potent cancer cell depletion activity, the observed specific interferons stimulation, immune responses-enhancement, and metastasis-reducing effects of THIO provide solid scientific foundation for further advancement of this compound in clinical development.”
A prominent characteristic of lung cancer small cells is their reliance on telomerase activity, a key enzyme essential for the continuous proliferation of SCLC. While 85-90% of all human cancers are telomerase positive, SCLCs are nearly all telomerase positive1, suggesting that telomerase targeting may be an effective strategy in the treatment of SCLC.
Key findings in the published paper include:
Human and mouse SCLC lines are sensitive to THIO (6TdG) treatment in vitro and in vivo
THIO decreases cancer initiating cells and diminishes tumor initiation potential in vitro and in vivo
Low doses of THIO are effective in treating metastatic mouse SCLC tumors
THIO activates type-I interferon pathway through cGAS-STING signaling
THIO is highly effective in combination with ionizing radiation treatment regiments
“With few, if any, effective treatments for small cell lung cancer, there is a widespread need for innovative therapeutic strategies. The positive outcomes reported in our publication show THIO’s potential as a new therapeutic approach,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “THIO already holds Orphan Drug Designation for SCLC, underscoring the FDA’s recognition of THIO’s potential to improve outcomes for this highly lethal disease. With the positive preclinical and clinical data we have obtained to date for THIO, we have entered the Phase 2 planning stage for a clinical trial of THIO in SCLC along with two other cancers.”
Orphan Products Development grants orphan designation status to drugs and biologics that are intended for the treatment, diagnosis or prevention of rare diseases, or conditions that affect fewer than 200,000 people in the U.S. Orphan Drug Designation provides certain benefits, including financial incentives, to support clinical development and the potential for up to seven years of market exclusivity for the drug for the designated orphan indication in the U.S. if the drug is ultimately approved for its designated indication.
About the Publication
Nature Communications, volume 15, article number: 672 (2024), “A telomere-targeting drug depletes cancer initiating cells and promotes anti-tumor immunity in small cell lung cancer,” published 22 January 2024. Co-author disclosures included in manuscript.
About Small Cell Lung Cancer
Small cell lung cancer (SCLC) accounts for 13% of lung cancers. As the deadliest of all lung cancers, SCLC is one of the leading causes of cancer-related mortality in United States with 30,000 deaths annually. It is less common than non-small cell lung cancer (NSCLC), but is more aggressive and rapidly spreads (metastasizes) throughout the body.
About THIO
THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleoside 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei activating both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.
About MAIA Biotechnology, Inc.
MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.
Forward Looking Statements
MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.
_________________________________ 1 Hiyama, K. et al. Telomerase activity in small-cell and non-small-cell lung cancers. J Natl Cancer Inst 87, 895-902, doi:10.1093/jnci/87.12.895 (1995).
Second Quarter of Fiscal Year 2024 – Consolidated Earnings Highlights
Revenue of $405.4 million
Net income of $19.4 million
Adjusted EBITDA* of $67.4 million
Raising Fiscal Year 2024 Guidance Ranges:
Revenue expected in a range of $1.23 billion to $1.3 billion vs prior range of $1.05 billion to $1.2 billion
Net loss expected in a range of $45 million to $22 million vs prior range of $50 million to $22 million
Adjusted EBITDA* expected in a range of $90 million to $105 million vs prior range of $80 million to $105 million
Second Quarter of Fiscal Year 2024 – Segment Highlights
Senior
Revenue of $247.5 million
Adjusted EBITDA* of $78.7 million
Approved Medicare Advantage policies of 234,576
Healthcare Services
Revenue of $111.7 million
Adjusted EBITDA* of $3.0 million
Over 62,000 SelectRx members
Life
Revenue of $37.4 million
Adjusted EBITDA* of $4.6 million
Auto & Home
Revenue of $10.5 million
Adjusted EBITDA* of $4.7 million
OVERLAND PARK, Kan.–(BUSINESS WIRE)– SelectQuote, Inc. (NYSE: SLQT) reported consolidated revenue for the second quarter of fiscal year 2024 of $405.4 million, compared to consolidated revenue for the second quarter of fiscal year 2023 of $319.2 million. Consolidated net income for the second quarter of fiscal year 2024 was $19.4 million, compared to consolidated net income for the second quarter of fiscal year 2023 of $22.5 million. Finally, consolidated Adjusted EBITDA* for the second quarter of fiscal year 2024 was $67.4 million, compared to consolidated Adjusted EBITDA* for the second quarter of fiscal year 2023 of $63.6 million.
Chief Executive Officer Tim Danker stated, “The second quarter marked SelectQuote’s eighth consecutive quarter of performance ahead of expectations, and we remain confident that our strategy to prioritize predictable and cash efficient growth will continue to generate value for both our customers and shareholders. We are also pleased with our progress on operating cash flow and now anticipate that SelectQuote will approach positive free cash flow in fiscal 2024.”
“SelectQuote drove strong results throughout the annual enrollment period for Medicare Advantage where our Senior business grew revenues by double digits, and our second quarter Adjusted EBITDA margin of 32% remains attractive. These strong Senior operating results were a function of higher tenured agent productivity and solid policyholder persistency, which we expect to benefit SelectQuote in the open enrollment period as well.”
“Additionally, Healthcare Services, and our SelectRx business specifically, drove substantial growth in excess of our original forecast. As of the end of the second quarter, SelectRx members have surpassed 62,000, which is in excess of our original expectation for the full year. More importantly, the business was again Adjusted EBITDA profitable.”
Mr. Danker continued, “We are pleased to increase our fiscal year 2024 outlook based on the strength of both businesses year-to-date.”
Segment Results
We currently report on four segments: 1) Senior, 2) Healthcare Services, 3) Life, and 4) Auto & Home. The performance measures of the segments include total revenue, Adjusted EBITDA,* and Adjusted EBITDA Margin.* Costs of revenue, cost of goods sold-pharmacy revenue, marketing and advertising, selling, general, and administrative, and technical development operating expenses that are directly attributable to a segment are reported within the applicable segment. Indirect costs of revenue, marketing and advertising, selling, general, and administrative, and technical development operating expenses are allocated to each segment based on varying metrics such as headcount. Adjusted EBITDA is calculated as total revenue for the applicable segment less direct and allocated costs of revenue, cost of goods sold, marketing and advertising, technical development, and selling, general, and administrative operating costs and expenses, excluding depreciation and amortization expense; gain or loss on disposal of property, equipment, and software; share-based compensation expense; and non-recurring expenses such as severance payments and transaction costs.
Combined Senior and Healthcare Services – Consumer Per Unit Economics
The opportunity to leverage our existing database and distribution model to improve access to healthcare services for our consumers has created a need for us to review our key metrics related to our per unit economics. As we think about the revenue and expenses for Healthcare Services, we note that they are derived from the marketing acquisition costs associated with the sale of an MA or MS policy, some of which costs are allocated directly to Healthcare Services, and therefore determined that our per unit economics measure should include components from both Senior and Healthcare Services. See details of revenue and expense items included in the calculation below.
Combined Senior and Healthcare Services consumer per unit economics represents total MA and MS commissions; other product commissions; other revenues, including revenues from Healthcare Services; and operating expenses associated with Senior and Healthcare Services, each shown per number of approved MA and MS policies over a given time period. Management assesses the business on a per-unit basis to help ensure that the revenue opportunity associated with a successful policy sale is attractive relative to the marketing acquisition cost. Because not all acquired leads result in a successful policy sale, all per-policy metrics are based on approved policies, which is the measure that triggers revenue recognition.
The MA and MS commission per MA/MS policy represents the LTV for policies sold in the period. Other commission per MA/MS policy represents the LTV for other products sold in the period, including DVH prescription drug plan, and other products, which management views as additional commission revenue on our agents’ core function of MA/MS policy sales. Pharmacy revenue per MA/MS policy represents revenue from SelectRx, and other revenue per MA/MS policy represents revenue from Population Health, production bonuses, marketing development funds, lead generation revenue, and adjustments from the Company’s reassessment of its cohorts’ transaction prices. Total operating expenses per MA/MS policy represents all of the operating expenses within Senior and Healthcare Services. The revenue to customer acquisition cost (“CAC”) multiple represents total revenue as a multiple of total marketing acquisition costs, which represents the direct costs of acquiring leads. These costs are included in marketing and advertising expense within the total operating expenses per MA/MS policy.
The following table shows combined Senior and Healthcare Services consumer per unit economics for the periods presented. Based on the seasonality of Senior and the fluctuations between quarters, we believe that the most relevant view of per unit economics is on a rolling 12-month basis. All per MA/MS policy metrics below are based on the sum of approved MA/MS policies, as both products have similar commission profiles.
Total revenue per MA/MS policy increased 37% for the twelve months ended December 31, 2023, compared to the twelve months ended December 31, 2022, primarily due to the increase in pharmacy revenue. Total operating expenses per MA/MS policy increased 23% for the twelve months ended December 31, 2023, compared to the twelve months ended December 31, 2022, driven by a 100% increase in operating expenses related to SelectRx due to the growth of the business, offset by a 3% decrease in other operating expenses driven by a decrease in marketing and advertising costs for the second half of fiscal year 2023 compared to the second half of fiscal year 2022.
*See “Non-GAAP Financial Measures” below.
Earnings Conference Call
SelectQuote, Inc. will host a conference call with the investment community today, Wednesday, February 7, 2024, beginning at 8:30 a.m. ET. To register for this conference call, please use this link: https://www.netroadshow.com/events/login?show=3bad4d79&confId=59966. After registering, a confirmation will be sent via email, including dial-in details and unique conference call codes for entry. Registration is open through the live call, but to ensure you are connected for the full call we suggest registering at least 10 minutes before the start of the call. The event will also be webcasted live via our investor relations website https://ir.selectquote.com/investor-home/default.aspx.
Non-GAAP Financial Measures
This release includes certain non-GAAP financial measures intended to supplement, not substitute for, comparable GAAP measures. To supplement our financial statements presented in accordance with GAAP and to provide investors with additional information regarding our GAAP financial results, we have presented in this release Adjusted EBITDA and Adjusted EBITDA Margin, which are non-GAAP financial measures. These non-GAAP financial measures are not based on any standardized methodology prescribed by GAAP and are not necessarily comparable to similarly titled measures presented by other companies. We define Adjusted EBITDA as income (loss) before interest expense, income tax expense (benefit), depreciation and amortization, and certain add-backs for non-cash or non-recurring expenses, including restructuring and share-based compensation expenses. The most directly comparable GAAP measure is net income (loss). We define Adjusted EBITDA Margin as Adjusted EBITDA divided by revenue. The most directly comparable GAAP measure is net income margin. We monitor and have presented in this release Adjusted EBITDA and Adjusted EBITDA Margin because they are key measures used by our management and Board of Directors to understand and evaluate our operating performance, to establish budgets and to develop operational goals for managing our business. In particular, we believe that excluding the impact of these expenses in calculating Adjusted EBITDA can provide a useful measure for period-to-period comparisons of our core operating performance.
We believe that these non-GAAP financial measures help identify underlying trends in our business that could otherwise be masked by the effect of the expenses that we exclude in the calculations of these non-GAAP financial measures. Accordingly, we believe these financial measures provide useful information to investors and others in understanding and evaluating our operating results, enhancing the overall understanding of our past performance and future prospects. Reconciliations of the differences between the non-GAAP financial measures included herein and their most directly comparable GAAP financial measures are set forth below beginning on page 12.
Forward Looking Statements
This release contains forward-looking statements. These forward-looking statements reflect our current views with respect to, among other things, future events and our financial performance. These statements are often, but not always, made through the use of words or phrases such as “may,” “should,” “could,” “predict,” “potential,” “believe,” “will likely result,” “expect,” “continue,” “will,” “anticipate,” “seek,” “estimate,” “intend,” “plan,” “projection,” “would” and “outlook,” or the negative version of those words or other comparable words or phrases of a future or forward-looking nature. These forward-looking statements are not historical facts, and are based on current expectations, estimates and projections about our industry, management’s beliefs and certain assumptions made by management, many of which, by their nature, are inherently uncertain and beyond our control. Accordingly, we caution you that any such forward-looking statements are not guarantees of future performance and are subject to risks, assumptions and uncertainties that are difficult to predict. Although we believe that the expectations reflected in these forward-looking statements are reasonable as of the date made, actual results may prove to be materially different from the results expressed or implied by the forward-looking statements.
There are or will be important factors that could cause our actual results to differ materially from those indicated in these forward-looking statements, including, but not limited to, the following: the impacts of the COVID-19 pandemic and any other public health events, our reliance on a limited number of insurance carrier partners and any potential termination of those relationships or failure to develop new relationships; existing and future laws and regulations affecting the health insurance market; changes in health insurance products offered by our insurance carrier partners and the health insurance market generally; insurance carriers offering products and services directly to consumers; changes to commissions paid by insurance carriers and underwriting practices; competition with brokers, including exclusively online brokers and carriers who opt to sell policies directly to consumers; competition from government-run health insurance exchanges; developments in the U.S. health insurance system; our dependence on revenue from carriers in our senior segment and downturns in the senior health as well as life, automotive and home insurance industries; our ability to develop new offerings and penetrate new vertical markets; risks from third-party products; failure to enroll individuals during the Medicare annual enrollment period; our ability to attract, integrate and retain qualified personnel; our dependence on lead providers and ability to compete for leads; failure to obtain and/or convert sales leads to actual sales of insurance policies; access to data from consumers and insurance carriers; accuracy of information provided from and to consumers during the insurance shopping process; cost-effective advertisement through internet search engines; ability to contact consumers and market products by telephone; global economic conditions, including inflation; disruption to operations as a result of future acquisitions; significant estimates and assumptions in the preparation of our financial statements; impairment of goodwill; potential litigation and other legal proceedings or inquiries; our existing and future indebtedness; our ability to maintain compliance with our debt covenants and meet our scheduled repayment obligations under out debt arrangement; our ability to access to additional capital on acceptable terms; failure to protect our intellectual property and our brand; fluctuations in our financial results caused by seasonality; accuracy and timeliness of commissions reports from insurance carriers; timing of insurance carriers’ approval and payment practices; factors that impact our estimate of the constrained lifetime value of commissions per policyholder; changes in accounting rules, tax legislation and other legislation; disruptions or failures of our technological infrastructure and platform; failure to maintain relationships with third-party service providers; cybersecurity breaches or other attacks involving our systems or those of our insurance carrier partners or third-party service providers; our ability to protect consumer information and other data; failure to market and sell Medicare plans effectively or in compliance with laws; and other factors related to our pharmacy business, including manufacturing or supply chain disruptions, access to and demand for prescription drugs, and regulatory changes or other industry developments that may affect our pharmacy operations. For a further discussion of these and other risk factors that could impact our future results and performance, see the section entitled “Risk Factors” in the most recent Annual Report on Form 10-K and subsequent periodic reports filed by us with the Securities and Exchange Commission. Accordingly, you should not place undue reliance on any such forward-looking statements. Any forward-looking statement speaks only as of the date on which it is made, and, except as otherwise required by law, we do not undertake any obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise.
About SelectQuote:
Founded in 1985, SelectQuote (NYSE: SLQT) provides solutions that help consumers protect their most valuable assets: their families, health, and property. The company pioneered the model of providing unbiased comparisons from multiple, highly-rated insurance companies allowing consumers to choose the policy and terms that best meet their unique needs. Two foundational pillars underpin SelectQuote’s success: a strong force of highly-trained and skilled agents who provide a consultative needs analysis for every consumer, and proprietary technology that sources and routes high-quality leads.
With an ecosystem offering high touchpoints for consumers across insurance, medicare, pharmacy, and value-based care, the company now has four core business lines: SelectQuote Senior, SelectQuote Healthcare Services, SelectQuote Life, and SelectQuote Auto and Home. SelectQuote Senior serves the needs of a demographic that sees around 10,000 people turn 65 each day with a range of Medicare Advantage and Medicare Supplement plans. SelectQuote Healthcare Services is comprised of the SelectRx Pharmacy, a Patient-Centered Pharmacy Home™ (PCPH) accredited pharmacy, and Population Health which proactively connects consumers with a wide breadth of healthcare services supporting their needs.
Atlanta, GA, February 6, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced positive initial safety and immune response findings from its Phase 2 clinical trial at one month following administration of its Covid-19 vaccine, GEO-CM04S1. The trial, evaluating GEO-CM04S1 as a heterologous booster in 63 healthy adults who had previously received the Pfizer or Moderna mRNA vaccine (ClinicalTrials.gov Identifier: NCT04639466), was fully enrolled at the end of Sept 2023.
The study is designed to evaluate the safety and immunogenicity of two GEO-CM04S1 dose levels. The trial remains blinded to dose of vaccine received, with study subjects being followed for a total of one year. To date, there have been no serious adverse events, and adverse events were in line with other routine vaccinations. The immunological responses measured throughout the study period include both neutralizing antibodies against SARS-CoV-2 variants and specific T-cell responses. Consolidated data from all subjects tested one-month post-vaccination, documented statistically significant increases in neutralizing antibody responses against multiple SARS-CoV-2 variants, ranging from the original Wuhan strain through Delta and Omicron XBB 1.5; additional testing against the JN.1 variant is underway.
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. These latest findings lend support to previously published findings in cell transplant patients of the ability of GEO-CM04S1 to stimulate functional antibody responses against a broad array of evolving SARS-CoV-2 virus variants (Chiuppesi et al, Vaccines, Sept 2023).
Kelly McKee, Jr., MD, MPH, GeoVax Chief Medical Officer, stated, “There is a critical need to address the recognized shortcomings of currently approved SARS-CoV-2 vaccines. Annual (or even more frequent) vaccination in a seemingly never-ending race to keep pace with this rapidly evolving virus is an unsustainable strategy. GEO-CM04S1 continues to demonstrate the ability to elicit broadly reactive functional antibodies in conjunction with robust and durable T-cell responses, offering the prospect of a next-generation solution to address these shortcomings.”
“We are thrilled by these data and our investigational vaccine designed to protect against severe disease caused by emerging variants of Covid-19,” said David Dodd, GeoVax Chairman and CEO. “These interim data reinforce our resolve to bring our expertise in the development of innovative vaccines to address critical public health needs using new approaches and technologies. We look forward to providing further updates regarding the successful progress of the clinical development of GEO-CM04S1.”
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.
SAN DIEGO, Feb. 06, 2024 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS), a Technology Company in the Defense, National Security and Global Markets and an industry-leading provider of high-performance, jet-powered unmanned aerial systems, recently welcomed U.S. Senator Gary Peters (D-MI) and U.S. Representative Lisa McClain (R-MI-9) to Technical Directions Inc. (TDI) headquartered in Oxford, Michigan, to showcase Kratos’ family of affordable turbine engines and turbogenerators.
Steve Fendley, President of Kratos Unmanned Systems Division, said, “TDI’s engines are a key enabler for producing small cruise missile and loitering munitions in mass, thanks to our laser-focus on manufacturability for scale with an incredibly high performance-to-cost ratio. These characteristics mirror the Kratos’ corporate strategy, but more importantly, provide a U.S. designed, manufactured, integrated, and tested affordable small-thrust-class turbine engine solution which has effectively been unachievable from U.S. manufacturers in recent years. We’re very proud of the products we’ve developed and proud to be growing in Michigan where we are able to leverage the deep experience of the automotive industry. We appreciate the opportunity to show them firsthand to Sen. Peters and Rep. McClain.”
TDI has developed and refined turbine engine technologies for military applications in Michigan since 1983—providing unique features in support of low-cost, high-production, expendable turbojet engine applications, such as small cruise missiles and other Unmanned Aerial Vehicles (UAVs). With the engineering, manufacturing, and system integration employees in the Oxford, Michigan facility, TDI’s subject matter experts leverage Michigan’s deep automotive expertise and apply it to the defense sector and have experience that encompasses all aspects of this turbine engine class, from clean-sheet design, through performance testing, vehicle integration, flight testing, and production manufacturing. By making its own internally funded investments that are not tied to any specific customer or budget process, TDI is able to rapidly develop and be first to market with its engines.
In 2023, Kratos received a $9 million contract award from the Department of Defense that, in addition to current and near-term program plans, is expected to rapidly increase TDI’s job, capability, and capacity growth trajectories, and advance TDI’s work bringing small engine turbine manufacturing back to the U.S. with the production rate and cost levels to support the DoD’s affordable mass needs of today and tomorrow.
Senator Peters, a member of the Senate Armed Services and Appropriations Committees, said, “Michigan defense manufacturers excel at producing innovative solutions to our most pressing national security challenges, and Kratos and the TDI team here in Oxford are a key partner in that success. It was great to see firsthand the important work they are doing to build the next-generation of defense technologies that protect our men and women in uniform, and to celebrate this new contract that will support Michigan-made products and jobs.”
“Touring the Kratos TDI facility this morning was a terrific experience that gave me a first-hand perspective of the work that goes into creating turbine engines and turbogenerators,” said Representative McClain. “I am proud that Kratos continues to call Oxford home, and I am excited to see their impact in the community grow throughout this year and beyond.”
About Kratos Defense & Security Solutions, Inc. Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS) is a technology, products, system and software company addressing the defense, national security, and commercial markets. Kratos makes true internally funded research, development, capital and other investments, to rapidly develop, produce and field solutions that address our customers’ mission critical needs and requirements. At Kratos, affordability is a technology, and we seek to utilize proven, leading-edge approaches and technology, not unproven bleeding edge approaches or technology, with Kratos’ approach designed to reduce cost, schedule and risk, enabling us to be first to market with cost effective solutions. We believe that Kratos is known as an innovative disruptive change agent in the industry, a company that is an expert in designing products and systems up front for successful rapid, large quantity, low-cost future manufacturing which is a value add competitive differentiator for our large traditional prime system integrator partners and also to our government and commercial customers. Kratos intends to pursue program and contract opportunities as the prime or lead contractor when we believe that our probability of win (PWin) is high and any investment required by Kratos is within our capital resource comfort level. We intend to partner and team with a large, traditional system integrator when our assessment of PWin is greater or required investment is beyond Kratos’ comfort level. Kratos’ primary business areas include virtualized ground systems for satellites and space vehicles including software for command & control (C2) and telemetry, tracking and control (TT&C), jet powered unmanned aerial drone systems, hypersonic vehicles and rocket systems, propulsion systems for drones, missiles, loitering munitions, supersonic systems, space craft and launch systems, C5ISR and microwave electronic products for missile, radar, missile defense, space, satellite, counter UAS, directed energy, communication and other systems, and virtual & augmented reality training systems for the warfighter. 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.
SAN DIEGO, Feb. 06, 2024 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS), a Technology Company in the Defense, National Security and Global Markets, announced today that it will publish financial results for the fourth quarter and fiscal year 2023 after the close of market on Tuesday, February 13th. Management will discuss the Company’s operations and financial results in a conference call beginning at 2:00 p.m. Pacific (5:00 p.m. Eastern).
The call will be available at www.kratosdefense.com. Participants may register for the call using this Online Form. Upon registration, all telephone participants will receive the dial-in number along with a unique PIN that can be used to access the call. For those who cannot access the live broadcast, a replay will be available on Kratos’ website.
About Kratos Defense & Security Solutions Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS) is a technology, products, system and software company addressing the defense, national security, and commercial markets. Kratos makes true internally funded research, development, capital and other investments, to rapidly develop, produce and field solutions that address our customers’ mission critical needs and requirements. At Kratos, affordability is a technology, and we seek to utilize proven, leading edge approaches and technology, not unproven bleeding edge approaches or technology, with Kratos’ approach designed to reduce cost, schedule and risk, enabling us to be first to market with cost effective solutions. We believe that Kratos is known as an innovative disruptive change agent in the industry, a company that is an expert in designing products and systems up front for successful rapid, large quantity, low cost future manufacturing which is a value add competitive differentiator for our large traditional prime system integrator partners and also to our government and commercial customers. Kratos intends to pursue program and contract opportunities as the prime or lead contractor when we believe that our probability of win (PWin) is high and any investment required by Kratos is within our capital resource comfort level. We intend to partner and team with a large, traditional system integrator when our assessment of PWin is greater or required investment is beyond Kratos’ comfort level. Kratos’ primary business areas include virtualized ground systems for satellites and space vehicles including software for command & control (C2) and telemetry, tracking and control (TT&C), jet powered unmanned aerial drone systems, hypersonic vehicles and rocket systems, propulsion systems for drones, missiles, loitering munitions, supersonic systems, space craft and launch systems, C5ISR and microwave electronic products for missile, radar, missile defense, space, satellite, counter UAS, directed energy, communication and other systems, and virtual & augmented reality training systems for the warfighter. For more information, visit www.KratosDefense.com
MustGrow has received The State of Oregon Agriculture approval to commence sales of TerraSanteTM, an organic biofertility product, in Oregon State.
MustGrow’s recently-awarded organic compliance certification from the USDA National Organic Program (OMRI Listed®) will apply to this Registration.
Mustard-derived TerraSanteTMfocuses on soil microbiome health, nutrient/water use efficiencies, and plant yields.
SASKATOON, Saskatchewan, Canada, February 6, 2024 – MustGrow Biologics Corp. (TSXV:MGRO) (OTC:MGROF) (FRA:0C0) (the “Company” or “MustGrow”) is pleased to announce receipt of The State of Oregon Agriculture Fertilizer Registration Certificate for its mustard plant-based TerraSanteTM, an organic biofertility product. TerraSanteTM’s recently-awarded organic compliance certification from the USDA National Organic Program (OMRI Listed®) will apply to TerraSanteTM product sales in Oregon State.
TerraSanteTM product sales may now commence in Oregon State, with a sales and marketing commercialization strategy already underway with BioAg Product Strategies for the 2024 planting season. In addition to Oregon State and recently-awarded Washington State, further state-level registrations are progressing in other key U.S. states.
In 2021, Oregon State recorded $5.0 billion USD in agriculture production on 16 million acres of farmland and contributed $2.6 billion USD in agriculture exports.(1) Agriculture plays a critical role in the state’s economy, generating 13% of the state’s gross product and $30 billion USD in wages.(1) Oregon farmers grow a wide variety of fruits and vegetables, including potatoes, tomatoes, strawberries, wine-making grapes, cherries, pears, and apples. Oregon farmers are regarded for their innovative commitment to sustainable agriculture with a rising trend toward organic and sustainable farming practices.(2) MustGrow believes its organic TerraSanteTM product will position Oregon farmers to meet increasing demand for organic, local, and healthy produce.
The MustGrow organic biofertility product will complement the Company’s existing biocontrol programs in preplant soil fumigation, postharvest food preservation, and bioherbicide, which are currently under development with four global partners: Bayer, Sumitomo Corporation, Janssen PMP, and NexusBioAg. These four partnered programs continue to achieve performance milestones and expand globally in scope and investment.
TerraSanteTM for Soil and Ecological Health
MustGrow’s soil amendment and biofertility development programs focus on soil microbiome health, nutrient and water use efficiencies, and plant yields. Soil is a farmer’s most valuable asset, and MustGrow’s mustard plant-based technologies are being developed with the intention to improve not only the health of the soil, but also the surrounding ecological environment.
As an organic biofertilizer in soluble mixable form, TerraSanteTM contains nutritious plant proteins and carbohydrates that feed soil microbes, potentially improving beneficial microbial activity and ensuring long-term sustainable soil health. These targeted micro-communities have been shown to work to improve nutrient availability, which can potentially increase plant vigor and yields, while reducing plant stress. TerraSanteTM has the potential to improve crop nutrient uptake and, hence, overall crop performance. There are no artificial additives or preservatives used during its manufacturing.
MustGrow is an agriculture biotech company developing organic biocontrol and biofertility products by harnessing the natural defense mechanism and organic materials of the mustard plant to sustainably protect the global food supply and help farmers feed the world. MustGrow and its leading global partners — Bayer, Janssen PMP (pharmaceutical division of Johnson & Johnson), Sumitomo Corporation, and Univar Solutions’ NexusBioAg — are developing mustard-based organic solutions for applications in biocontrol to potentially replace harmful synthetic chemicals in preplant soil treatment and weed control, to postharvest disease control and food preservation. Bayer has a commercial agreement to develop and commercialize MustGrow’s biocontrol soil applications in Europe, Africa, and the Middle East. Concurrently, with new formulations derived from food-grade mustard, the Company is pursuing the adoption and use of its first registered and OMRI Listed® product, TerraSanteTM, in key U.S. states. Over 150 independent tests have been completed, validating MustGrow’s safe and effective approach to crop and food protection and yield enhancements. Pending regulatory approval, MustGrow’s patented liquid technologies could be applied through injection, standard drip or spray equipment, improving functionality and performance features. MustGrow has approximately 51.5 million basic common shares issued and outstanding and 54.2 million shares fully diluted. For further details, please visit www.mustgrow.ca.
Contact Information
Corey Giasson Director & CEO Phone: +1-306-668-2652 info@mustgrow.ca
MustGrow Forward-Looking Statements
Certain statements included in this news release constitute “forward-looking statements” which involve known and unknown risks, uncertainties and other factors that may affect the results, performance or achievements of MustGrow.
Generally, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “expects”, “is expected”, “budget”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might”, “occur” or “be achieved”. Examples of forward-looking statements in this news release include, among others, statements MustGrow makes regarding: the commencement of TerraSanteTM product sales in Oregon State; the progress of state-level registrations of TerraSanteTM products in other states; whether the TerraSanteTM product will position Oregon farmers to meet increasing demand for organic, local, and healthy produce; whether MustGrow’s organic biofertility product will complement the Company’s existing biocontrol programs in preplant soil fumigation, postharvest food preservation, and bioherbicide; whether MustGrow’s four partnered programs will continue to achieve performance milestones and expand globally in scope and investment; whether targeted micro-communities can increase plant vigor and yields, while reducing plant stress; and the potential for TerraSanteTM to improve crop nutrient uptake and, hence, overall crop performance. Forward-looking statements are subject to a number of risks and uncertainties that may cause the actual results of MustGrow to differ materially from those discussed in such forward-looking statements, and even if such actual results are realized or substantially realized, there can be no assurance that they will have the expected consequences to, or effects on, MustGrow. Important factors that could cause MustGrow’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include market receptivity to investor relations activities as well as those risks described in more detail in MustGrow’s Annual Information Form for the year ended December 31, 2022 and other continuous disclosure documents filed by MustGrow with the applicable securities regulatory authorities which are available at www.sedar.com. Readers are referred to such documents for more detailed information about MustGrow, which is subject to the qualifications, assumptions and notes set forth therein.
This release does not constitute an offer for sale of, nor a solicitation for offers to buy, any securities in the United States.
Neither the TSXV, nor their Regulation Services Provider (as that term is defined in the policies of the TSXV), nor the OTC Markets has approved the contents of this release or accepts responsibility for the adequacy or accuracy of this release.
BY THE COMTECH EDITORIAL TEAM – FEB 5, 2024 | 3 MIN READ
MELVILLE, N.Y. – February 5, 2024– Comtech (NASDAQ: CMTL) announced today that Washington State recently awarded the company a $48 million contract extension to continue providing Next Generation 911 (NG911) services over the next five years, with the option to extend through 2034.
Washington State initially contracted Comtech to design, deploy and operate next generation public safety technologies and secure and reliable communications capabilities in 2016, making Washington a national leader in the application of NG911 services.
“We value our continued partnership with Washington State and have worked collaboratively over the past eight years to deploy one of the most robust and advanced NG911 systems in the United States,” said Ken Peterman, President and CEO, Comtech. “This contract extension award further demonstrates the state of Washington’s trust of our NG911 capabilities to support the state’s public safety mission. As we continue to support the state of Washington, we look forward to exploring emerging capabilities like artificial intelligence to equip first responders with life-saving insights at the speed of relevance.”
“The Washington State NG911 enterprise system provides people in crisis with a more effective 911 service and has saved countless lives in the eight years since we initially partnered with Comtech,” said Adam Wasserman, Assistant Director for Emergency Communications, Washington State Emergency Management Division. “Our NG911 system keeps pace with the ever-evolving communications technologies used by the citizens in our state. In addition, due to the increased reliability, resilience and security, as well as the designed interoperability with other 911 centers – intrastate, interstate, and international (Canada) – the Washington State NG911 enterprise system is more effective at collecting and disseminating initial situational awareness during major emergencies and disasters.”
As one of the most trusted providers of public safety technologies, Comtech is continuing to expand its NG911 offerings for governments and emergency response providers around the world. The company’s NG911 systems are designed to adapt and continuously evolve over time to meet the needs of emerging use cases as well as future applications.
About the State of Washington 911 Coordination Office
The 911 Unit of the Emergency Management Division works to ensure the seamless operation of the statewide 911 communications system, ensuring uniform, prompt, and efficient access to public safety services for the citizens and visitors to the state of Washington.
Washington has 86 Public Safety Answering Points (911 centers) that cover all 39 counties within the state. The PSAPs are connected to the statewide Emergency Services IP Network (ESInet), which delivers location information of the 911 caller as well as other data needed.
In addition to contracting for the statewide 911 network, the 911 Unit provides fiscal and technical assistance to counties and PSAPs to support 911 operations. The 911 Unit continues to drive the evolution of the 911 network to accommodate the advances in communication technologies such as wireless, VoIP-based communications and the myriad of upcoming non-traditional technologies.
About Comtech
Comtech Telecommunications Corp. is a leading global technology company providing terrestrial and wireless network solutions, next-generation 911 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.
