The biotech and healthcare sectors have seen a flurry of activity in recent weeks, with companies making strides through drug developments, clinical trials, and corporate milestones. Two firms generating buzz today are Adial Pharmaceuticals (ADIL) and Skye Bioscience (SKYE), both reporting encouraging news that has fueled investor interest.
Adial Pharmaceuticals, a clinical-stage biopharmaceutical company focused on developing addiction therapies, announced the publication of a peer-reviewed article highlighting the promising safety data and high patient compliance observed with its lead investigational drug AD04 in a Phase 3 clinical trial for alcohol use disorder (AUD).
The study, published in the European Journal of Internal Medicine, comprehensively analyzed the liver safety profile of low-dose AD04 compared to a placebo in patients with AUD and a specific genetic profile. Notably, AD04 did not significantly impact biochemical markers of liver injury like ALT, AST, and bilirubin levels, underscoring its potential to address AUD while mitigating liver damage risks.
Moreover, AD04 demonstrated an impressive safety and tolerability profile, with low adverse event occurrence, high medication adherence, and minimal dropout rates – a rarity for AUD treatments. Adial’s CEO, Cary Claiborne, expressed enthusiasm about providing a precision treatment tailored to individuals with AUD, potentially offering a novel approach to managing alcohol consumption and liver harm.
Separately, Skye Bioscience (SKYE), a clinical-stage biotech focused on the endocannabinoid system, achieved a significant milestone by uplisting its common stock to the Nasdaq Global Market. Trading under the ticker “SKYE” is expected to commence on April 11th.
The Nasdaq uplisting is a testament to Skye’s recent accomplishments, including advancing its Phase 2 clinical programs, strengthening its financial position, and broadening its shareholder base. As CFO Kaitlyn Arsenault noted, the move aims to enhance visibility, liquidity, and ultimately drive long-term shareholder value.
Skye’s pipeline includes SBI-100 Ophthalmic Emulsion, a CB1 agonist being studied in a Phase 2 trial for glaucoma and ocular hypertension, with top-line data expected this quarter. Additionally, the company plans to launch a Phase 2 clinical trial in Q3 2024 for nimacimab, a peripheral CB1 inhibitor, targeting obesity through monotherapy and combination arms with a GLP-1R agonist.
With the biotech and healthcare industries consistently evolving, such conferences play a crucial role in fostering collaboration, facilitating knowledge-sharing, and driving progress towards improving patient outcomes and advancing healthcare solutions.
As companies like Adial and Skye continue to make strides, the broader biotech and healthcare sectors remain vibrant and poised for growth, fueled by scientific advancements, regulatory approvals, and investor confidence. The upcoming Noble Capital Markets Virtual Healthcare Conference promises to further catalyze innovation and propel the industry forward.
Inflation picked up speed in March, with consumer prices rising at a faster pace than anticipated. The higher-than-expected inflation data throw cold water on hopes that the Federal Reserve will be able to start cutting interest rates anytime soon.
The Consumer Price Index (CPI), which measures the costs of a broad basket of goods and services across the economy, rose 0.4% in March from the previous month. That pushed the 12-month inflation rate up to 3.5% compared to 3.2% in the year through February.
Economists had forecast the CPI would rise 0.3% on a monthly basis and 3.4% annually.
The acceleration in inflation was driven primarily by two major categories – shelter and energy costs.
Housing costs, which make up about one-third of the CPI’s weighting, climbed 0.4% from February and are now up 5.7% over the past 12 months. Rising rents and home prices get reflected in the shelter component.
Energy prices increased 1.1% in March after already jumping 2.3% in February. Gasoline costs have remained elevated despite recent pullbacks.
Stripping out the volatile food and energy components, core CPI also rose 0.4% for the month and 3.8% annually – both higher than expected.
The stronger-than-expected inflation readings make it more challenging for the Fed to start lowering interest rates in the coming months as financial markets had anticipated. Traders had priced in expectations that the first rate cut would occur by June based on Chairman Jerome Powell’s comments that inflation was headed lower.
However, following the hot March data, markets now project the Fed’s first rate reduction won’t come until September at the earliest. Some economists believe even a July rate cut now looks unlikely.
The acceleration in inflation puts the Fed in a difficult position as it tries to navigate bringing stubbornly high price pressures under control without crashing the economy. Policymakers have emphasized the need to see more concrete evidence that inflation is cooling in a sustained way before easing up on rate hikes.
Fed officials have pointed to an expected deceleration in housing costs, which tend to be sticky, as a key reason inflation should slow in the coming months. But the March data showed rents continuing to increase at an elevated pace.
The services inflation component excluding energy picked up to a 5.4% annual rate. The Fed views services prices as a better indicator of more durable inflationary pressures in the economy.
Some bright spots in the report included lower used vehicle prices, which declined 1.1%. Food costs only increased 0.1% with lower prices for butter, cereal and baked goods offsetting a big 4.6% jump in egg prices.
Overall, the March CPI report suggests the Fed still has more work to do in taming inflation back to its 2% target. Traders are now pricing in higher terminal interest rates and little chance of rate cuts in 2023 following the inflation surprise.
Persistently elevated inflation could ultimately force the Fed to hike rates higher than expected, raising risks of a harder economic slowdown. The central bank will provide more clues on its policy outlook when it releases minutes from its March meeting on Wednesday afternoon.
For consumers feeling the pinch of high prices, the March CPI data means little relief is likely coming anytime soon on the inflation front. The big question is how long stubbornly high inflation will persist and exacerbate the already difficult trade-offs facing the Federal Reserve.
BY THE COMTECH EDITORIAL TEAM – APR 10, 2024 | 2 MIN READ
CHANDLER, Ariz. – April 10, 2024– Comtech (NASDAQ: CMTL) (the “Company”), a global technology leader, in partnership with the Arizona Department of Administrations (“ADOA”), today announced the successful completion of a statewide transition to Comtech’s Next Generation 911 (“NG911”) services. Arizona’s new statewide NG911 infrastructure is designed to significantly enhance the ability of first responders and public safety answering points (“PSAPs”) to respond faster to emergencies and provide more comprehensive and reliable 911 services to Arizona residents.
In less than two years, Comtech and the ADOA successfully migrated the state’s legacy 911 system to the new infrastructure. The Arizona NG911 program modernizes the state’s emergency response capabilities and enhances the efficiency, effectiveness and reliability of 911 services, while enabling new capabilities such as geospatial location routing and improved redundancy, as well as the implementation of a new Emergency Service IP Network (“ESiNET”).
“We are honored to partner with the State of Arizona to deploy one of the nation’s most robust NG911 infrastructures,” said John Ratigan, Interim CEO of Comtech. “With this statewide deployment, Arizona residents benefit from a much higher rate of call reliability and new multi-media and location services, which can save critical time during emergencies. Comtech has worked closely with the ADOA and state leaders to integrate multiple legacy networks to create a new unified NG911 infrastructure, and we are confident this transition helps ensure residents get the help they need when seconds matter most.”
“The efficiency of this deployment can serve as a model for the rest of the United States, and we are pleased to work with Comtech to roll out these lifesaving NG911 services to better protect Arizona residents,” said Travis Jensen, Program Administrator of the ADOA 911 Program. “We look forward to continuing our partnership and bringing new capabilities to residents as they become available.”
The Arizona NG911 statewide transition involved upgrading and integrating a wide range of 911 technologies, including call handling, dispatch, mapping and database systems. It also required implementing new protocols and standards to ensure interoperability and compatibility with other systems and networks.
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 Comtech
Comtech Telecommunications Corp. (“Comtech”) 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. 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.
MALVERN, Pa., April 10, 2024 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, and vaccines, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) reviewed the study design, endpoints and planned statistical analysis of the pivotal OCU400 Phase 3 liMeliGhT clinical trial for retinitis pigmentosa (RP) and provided acceptability of the U.S.-based trial for submission of a Marketing Authorization Application (MAA).
EMA provided this opinion based on safety and tolerability of OCU400 demonstrated in the Phase 1/2 study. The Phase 3 liMeliGhT study will have a sample size of 150 participants primarily in the U.S.—one arm of 75 participants with RHO gene mutations and the other arm with 75 participants that are gene agnostic (representing multiple gene mutations associated with RP). In each arm, participants will be randomized 2:1 to the treatment group (2.5 x 1010 vg/eye of OCU400) and untreated control group, respectively.
The positive scientific advice from EMA is in alignment with U.S. FDA clearance of the IND amendment to initiate the Phase 3 liMeliGhT clinical trial of OCU400. OCU400 is the first gene therapy to enter Phase 3 with a broad RP indication. Previously, OCU400 received broad Orphan Drug Designation for RP and Leber congenital amaurosis in the EU.
“We are very grateful to EMA for their collaborative discussions and support in providing a gene-agnostic therapeutic option to RP patients with severe unmet medical need,” said Dr. Shankar Musunuri, Chairman, CEO and Co-founder of Ocugen. “This positive opinion is a critical step in providing our game-changing modifier gene therapies to patients globally.”
The EMA opinion is an extremely favorable outcome, as it will potentially reduce the time and cost to gain marketing authorization in the EU. With this milestone, OCU400 remains on track for 2026 BLA and MAA approval targets.
About OCU400 OCU400 is the Company’s gene-agnostic modifier gene therapy product based on NHR gene, NR2E3. NR2E3 regulates diverse physiological functions within the retina—such as photoreceptor development and maintenance, metabolism, phototransduction, inflammation and cell survival networks. Through its drive functionality, OCU400 resets altered/affected cellular gene-networks and establishes homeostasis—a state of balance, which has the potential to improve retinal health and function in patients with inherited retinal diseases.
About RP RP is a group of rare, genetic disorders that involve a breakdown and loss of cells in the retina, leading to vision loss and blindness. Currently, RP is associated with mutations in more than 100 genes.
There are no approved treatment options that slow or stop the progression of multiple forms of RP. Proposed treatments for RP include gene-replacement therapy, retinal implant devices, retinal transplantation, stem cells, vitamin therapy, and other pharmacological treatments. Current gene-replacement therapies are promising but are limited to treating just a single mutation. In addition, while gene therapies may provide a new functional gene, they do not necessarily eliminate the underlying genetic defect, which may still cause stress and toxic effects leading to retina degeneration. Therefore, the development of gene-specific replacement therapy is highly challenging, especially when multiple and unknown genes are involved. Thus, novel therapeutic approaches targeting broader RP disease in a gene agnostic manner offer greater hope for patients.
About Ocugen, Inc. Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on X and LinkedIn.
Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.
LOS ALTOS, Calif., April 10, 2024 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company or “Unicycive”), today announced that Shalabh Gupta, M.D., Chief Executive Officer will present a company update at the Noble Capital Markets Emerging Growth Virtual Healthcare Equity Conference on Thursday April 18, 2024 at 11:00 a.m. ET.
A link to the live and archived webcast may be accessed on the Unicycive website under the Investors section: Events and Presentations. An archive of the webcast will be available for three months.
About Unicycive Therapeutics
Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. UNI-494 is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury. For more information, please visit Unicycive.com and follow us on LinkedIn and YouTube.
Conference Call to be held Thursday, April 25 at 8:00 a.m. Central Time
HOUSTON, April 09, 2024 (GLOBE NEWSWIRE) — Orion Group Holdings, Inc. (NYSE: ORN) (the “Company”), a leading specialty construction company, today announced that it will issue its first quarter 2024 financial results after the close of the stock market on Wednesday, April 24, 2024.
A conference call and audio webcast with analysts and investors will be held the next day, Thursday April 25, at 9:00 a.m. Eastern Time/8:00 a.m. Central Time to discuss the results and answer questions.
Orion Group Holdings, Inc., a leading specialty construction company serving the infrastructure, industrial and building sectors, provides services both on and off the water in the continental United States, Alaska, 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)
QuoteMedia is a leading software developer and cloud-based syndicator of financial market information and streaming financial data solutions to media, corporations, online brokerages, and financial services companies. The Company licenses interactive stock research tools such as streaming real-time quotes, market research, news, charting, option chains, filings, corporate financials, insider reports, market indices, portfolio management systems, and data feeds. QuoteMedia provides industry leading market data solutions and financial services for companies such as the Nasdaq Stock Exchange, TMX Group (TSX Stock Exchange), Canadian Securities Exchange (CSE), London Stock Exchange Group, FIS, U.S. Bank, Broadridge Financial Systems, JPMorgan Chase, CI Financial, Canaccord Genuity Corp., Hilltop Securities, HD Vest, Stockhouse, Zacks Investment Research, General Electric, Boeing, Bombardier, Telus International, Business Wire, PR Newswire, FolioFN, Regal Securities, ChoiceTrade, Cetera Financial Group, Dynamic Trend, Inc., Qtrade Financial, CNW Group, IA Private Wealth, Ally Invest, Inc., Suncor, Virtual Brokers, Leede Jones Gable, Firstrade Securities, Charles Schwab, First Financial, Cirano, Equisolve, Stock-Trak, Mergent, Cision, Day Trade Dash and others. Quotestream®, QModTM and Quotestream ConnectTM are trademarks of QuoteMedia. For more information, please visit www.quotemedia.com.
Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.
Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Q4 results. The company reported softer than expected results in Q4. Revenue and adj. EBITDA were $4.7 million and $0.7 million in the quarter, modestly below our estimates of $5.0 million and $0.9 million, respectively. Q4 revenue growth was 3.1%, a deceleration from 8.5% growth in Q3. We believe that revenue was impacted by lower customer data usage.
Pipeline appears favorable. Management highlighted the shift to first party data as a significant development that should improve the company’s value proposition to clients. Notably, the company has roughly $1.0 million in deferred revenue in the quarter, which will be booked as the business comes on line.
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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
The red hot U.S. economy has financial markets caught between fears of overheating versus overtightening, leading to a tense environment of volatility and angst. U.S. stocks fell sharply on Tuesday, reversing early gains, as investors grew nervous ahead of this week’s critical inflation report that could help shape the Federal Reserve’s policy path.
All eyes are on Wednesday’s March Consumer Price Index (CPI) data, with economists forecasting headline inflation accelerated to 3.4% year-over-year, up from 3.2% in February. The more closely watched core measure excluding food and energy is expected to ease slightly to 3.7% from 3.8%.
The CPI print takes on heightened importance after a slate of robust economic data has traders quickly recalibrating expectations for Fed rate cuts this year. At the start of 2024, markets were pricing in up to 150 basis points of easing as worries about a potential recession peaked. But those easing bets have been dramatically pared back to just around 60 basis points currently.
The shift highlights how perspicacious the “no landing” scenario of stubbornly high inflation forcing the Fed to remain restrictive has become. Traders now only see a 57% chance of at least a 25 basis point cut at the June FOMC meeting, down from 64% just last week.
“Given the strength of the economic data, it’s getting easier and easier to defend the notion that we might be closer to an overheating economy than one nearing recession,” said Dave Grecsek at Aspiriant. “At the moment, three rate cuts this year seems a little demanding.”
Tuesday’s market turmoil underscored this increased skittishness around the inflation trajectory and its policy implications. Major U.S. indices fell, with the Dow Jones Industrial Average dropping 0.38%, the S&P 500 off 0.32%, and the Nasdaq Composite declining 0.17%.
The sell-off was broad-based, impacting many of the high-growth tech leaders that have powered the market’s gains so far in 2024. Megacap growth stocks including Nvidia, Meta Platforms, and Microsoft fell between 0.2% and 2.9%. Financial stocks, among the most rate-sensitive sectors, were the worst performers on the day with the S&P 500 Financials index down 0.8%.
The heightened volatility and economic uncertainty has been particularly punishing for the small and micro-cap segments of the market. These smaller, higher-risk companies tend to underperform during turbulent periods as investor appetite for risk diminishes. The Russell 2000 index of small-cap stocks fell 1.2% on Tuesday and is down over 5% from its highs just two weeks ago.
Cryptocurrency and blockchain-related stocks also got caught up in the downdraft, with Coinbase Global and MicroStrategy dropping sharply as bitcoin prices tumbled. Moderna bucked the bearish trend with a 6.9% surge after positive data for its cancer vaccine developed with Merck.
Geopolitical tensions around Iran’s threat to potentially close the critical Strait of Hormuz shipping lane added another layer of anxiety.
While some might view the market jitters as a buying opportunity, the unease is unlikely to dissipate soon given the Fed uncertainty. Investors will be closely scrutinizing the minutes from the March FOMC meeting due out on Wednesday as well for additional clues on policymakers’ latest thinking.
With inflation proving stickier than expected, the Fed has increasingly pushed back against market pricing for rate cuts this year. Several Fed officials have emphasized that any cuts in 2024 are far from assured if inflation does not moderate substantially. That will keep all eyes laser-focused on each CPI print going forward.
Markets have been whipsawed by conflicting economic signals and rampant volatility as investors try to game the unpredictable path ahead. With high stakes riding on the inflation trajectory and its policy implications, intense swings are likely to persist as markets grapple with this high-wire act between overheating and overtightening.
AdTheorent Also Wins Four Campaign-Based MMA SMARTIES™ X Global Awards with Valued Partners The Wine Group, TRG, and Choctaw Casinos & Resorts
NEW YORK, April 9, 2024 /PRNewswire/ — AdTheorent Holding Company, Inc. (Nasdaq: ADTH), a machine learning pioneer using privacy-forward solutions to deliver measurable value for programmatic advertisers, today announced that it was named “Enabling Technology Company of the Year” as part of the MMA SMARTIES™ X Global awards. In addition, AdTheorent won four campaign-specific MMA SMARTIES™ X Global awards with valued partners The Wine Group, TRG, and Choctaw Casinos & Resorts. The prestigious MMA SMARTIES™ X Global awards program recognizes the most innovative and impactful marketing campaigns across the globe, showcasing the brilliance of marketing professionals who push boundaries and redefine industry standards to shape the future of creativity and innovation in marketing.
The SMARTIES X Global 2023 presented 35 Gold, 35 Silver, and 30 Bronze category awards, along with 10 Industry Awards recognizing outstanding achievements across various categories.
“On behalf of the AdTheorent team, we are honored to be recognized as ‘Enabling Technology Company of the Year’ in the prestigious MMA SMARTIES™ X Global Awards, which is the result of our 12-year commitment to machine-learning based innovation and technological advancement,” said Jim Lawson, CEO of AdTheorent. “We are also honored to win four campaign-based awards with our innovative partners at The Wine Group and TRG,” said Jim Lawson, CEO of AdTheorent. “AdTheorent’s mission is to make programmatic advertising more valuable and efficient for marketers – and we sincerely thank the esteemed MMA SMARTIES™ GLOBAL X judges for this prestigious recognition.”
Specifics on AdTheorent’s MMA SMARTIES™ X Global awards include:
INDUSTRY AWARD: This recognition is given to 10 companies that represent inspiring examples of excellence, setting a high standard for the marketing industry:
View the complete MMA SMARTIES™ X Global 2023 Winner Gallery here, and the judges’ roster here.
The SMARTIES™ X Global awards continue to be a beacon of recognition for outstanding marketing achievements, celebrating the individuals and organizations driving meaningful change across the world.
About AdTheorent AdTheorent (Nasdaq: ADTH) uses advanced machine learning technology and privacy-forward solutions to deliver impactful advertising campaigns for marketers. AdTheorent’s machine learning-powered media buying platform powers its predictive targeting, predictive audiences, geo-intelligence, audience extension solutions and in-house creative capability, Studio A\T. Leveraging only non-sensitive data and focused on the predictive value of machine learning models, AdTheorent’s product suite and flexible transaction models allow advertisers to identify the most qualified potential consumers coupled with the optimal creative experience to deliver superior results, measured by each advertiser’s real-world business goals.
AdTheorent is consistently recognized with numerous technology, product, growth and workplace awards. AdTheorent was named “Best Buy-Side Programmatic Platform” in the 2023 Digiday Technology Awards and was honored with an AI Breakthrough Award and “Most Innovative Product” (B.I.G. Innovation Awards) for five consecutive years. Additionally, AdTheorent is the only seven-time recipient of Frost & Sullivan’s “Digital Advertising Leadership Award.” AdTheorent is headquartered in New York, with fourteen locations across the United States and Canada. For more information, visit adtheorent.com.
About MMA Global: MMA Global is the leading global trade association for marketers, providing essential resources and expertise to empower marketers to navigate the complex world of Marketing. With a commitment to driving innovation and effectiveness, MMA Global plays a pivotal role in shaping the future of marketing. Find out more about MMA Global at https://www.mmaglobal.com/
About the SMARTIES: SMARTIES is the prestigious marketing awards program hosted by MMA Global, recognizing excellence in Marketing. The SMARTIES Awards celebrate the most innovative and impactful campaigns that push the boundaries of creativity and effectiveness in the dynamic world of mobile marketing.
FDA designation provides potentially seven years of market exclusivity after approval and expanded partnering opportunities for tecarfarin
PONTE VEDRA, Fla., April 9, 2024 — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin, a late-stage novel oral and reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients with rare cardiovascular conditions, announced today that the United States Food and Drug Administration (FDA) has granted tecarfarin Orphan Drug Designation (ODD) for the prevention of thromboembolism and thrombosis in patients with an implanted mechanical circulatory support device (left ventricular assist device (LVAD), right ventricular assist device (RVAD), collectively known as ventricular assist devices (VADs), biventricular assist device, and total artificial heart).
“This second orphan drug designation highlights the expanded need for tecarfarin where existing anticoagulation therapies are inadequate,” said Quang Pham, Founder, Chairman and Chief Executive Officer of Cadrenal Therapeutics. “We are dedicated to advancing tecarfarin through clinical development options as swiftly as possible.”
The FDA’s ODD program provides incentives to sponsor organizations for the development of innovative treatments for rare diseases that affect fewer than 200,000 people in the U.S. Since its adoption in 1983, the Orphan Drug Act has helped countless individuals living with these conditions gain access to life-enhancing and life-saving therapies. ODD also provides certain benefits to drug developers, including assistance in the drug development process, tax credits for certain clinical research, and a waiver of the New Drug Application user fee. The designation is made to promote safe and efficacious products for the treatment of rare conditions.
All patients with VADs require chronic anticoagulation to prevent the formation of thrombus (clot) which can cause the device to fail or can result in a clot breaking off (embolizing), resulting in a stroke or other vascular catastrophe.
The current market-leading direct oral anticoagulants (DOACs), such as Eliquis, are not indicated for patients with VADs due to a lack of evidence of benefit. Moreover, a recent study revealed that the level of anticoagulation achieved with warfarin, the only currently available Vitamin K Antagonist (VKA), is maintained in the target range only 56% of the time which has been shown to increase the risk of clotting and bleeding complications.
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 rare cardiovascular 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) and just received orphan drug designation for the prevention of thrombosis and thromboembolism in patients with ventricular assist devices (VADs). Cadrenal is also pursuing additional regulatory strategies for unmet needs in anticoagulation therapy for patients 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 tecarfarin addressing unmet needs in anticoagulation therapy and the ability to derive the anticipated and potential benefits from the recent Orphan Drug Designation for tecarfarin, including seven years of market exclusivity, and the expanded development and commercial partnering for tecarfarin as a result of the Orphan Drug Designation. 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 Company’s ability to derive the anticipated benefits from the recent Orphan Drug Designation for tecarfarin and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, and the Company’s filings with the Securities and Exchange Commission, including 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
BRENTWOOD, Tenn., April 08, 2024 (GLOBE NEWSWIRE) — CoreCivic, Inc. (NYSE: CXW) (the Company) announced today that it will release its 2024 first quarter financial results after the market closes on Wednesday, May 8, 2024. A live broadcast of CoreCivic’s conference call will begin at 10:00 a.m. central time (11:00 a.m. eastern time) on Thursday, May 9, 2024.
To participate via telephone and join the call live, please register in advance here https://register.vevent.com/register/BIa41ba53918294659afa34f33febf12cc. Upon registration, telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number and a unique passcode.
Participants may access the audio-only webcast of the conference call from the Company’s website at www.corecivic.com under the “Events & Presentations” section of the “Investors” page. A replay of the webcast will be available for seven days.
About CoreCivic CoreCivic is a diversified, government-solutions company with the scale and experience needed to solve tough government challenges in flexible, cost-effective ways. We provide a broad range of solutions to government partners that serve the public good through high-quality corrections and detention management, a network of residential and non-residential alternatives to incarceration to help address America’s recidivism crisis, and government real estate solutions. We are the nation’s largest owner of partnership correctional, detention and residential reentry facilities, and one of the largest prison operators in the United States. We have been a flexible and dependable partner for government for 40 years. Our employees are driven by a deep sense of service, high standards of professionalism and a responsibility to help government better the public good. Learn more at www.corecivic.com.
Contact:
Investors: Michael Grant – Managing Director, Investor Relations – (615) 263-6957 Media: Steve Owen – Vice President, Communications – (615) 263-3107
PHOENIX, April 08, 2024 (GLOBE NEWSWIRE) — QuoteMedia, Inc. (OTCQB: QMCI), a leading provider of market data and financial applications, announced financial results for the fiscal year ended December 31, 2023.
QuoteMedia provides banks, brokerage firms, private equity firms, financial planners and sophisticated investors with a more economical, higher quality alternative source of stock market data and related research information. We compete with several larger legacy organizations and a modest community of other smaller companies. QuoteMedia provides comprehensive market data services, including streaming data feeds, on-demand request-based data (XML/JSON), web content solutions (financial content for website integration) and applications such as Quotestream Professional desktop and mobile.
Highlights for fiscal 2023 include the following:
Annual revenue increased to $18,907,725 in 2023 from $17,527,605 in 2022, an increase of $1,380,120 (8%).
Net income for 2023 was $361,584 compared to $444,470 in 2022, a decrease in profitability of $82,886.
Adjusted EBITDA for 2023 was $3,039,507 compared to $2,727,411 in 2022, an improvement of $312,096.
“This was an important year for QuoteMedia,” said Robert J. Thompson, Chairman of the Board. “We invested in a major data consolidation initiative that allows us to significantly reduce our dependence on 3 rd party data providers and reduce our data sourcing costs. This has been a long, difficult and costly process, but we are already beginning to enjoy the benefits, as we have much greater flexibility and control in servicing our clients, at lower costs.
“2023 resulted in the completion of some major client deployments, and the startup of new client deployments that are currently in progress. Discussions and negotiations on several other large-scale projects expected to be closed in 2024, were also commenced.
“While we experienced strong revenue growth, our profitability was somewhat dampened due to some large one-time expenses incurred in relation to completing the data consolidation initiative and in changing public accounting firms. Moving forward, we expect to see an improvement in profitability as our professional fees normalize, and our revenue and gross margin percentages increase.
“Our teams have put in a tremendous amount of very productive hard work this year. We are very pleased with what we have accomplished, and we look forward to enhanced success in the years to come.”
QuoteMedia will host a conference call Tuesday, April 9, 2024, at 2:00 PM Eastern Time to discuss the 2023 financial results and provide a business update.
Conference Call Details:
Date: April 9, 2024
Time: 2:00 PM Eastern
Dial-in number: 800-901-2707
Conference ID: QUOTEMEDIA
An audio rebroadcast of the call will be available later at: www.quotemedia.com
About QuoteMedia
QuoteMedia is a leading software developer and cloud-based syndicator of financial market information and streaming financial data solutions to media, corporations, online brokerages, and financial services companies. The Company licenses interactive stock research tools such as streaming real-time quotes, market research, news, charting, option chains, filings, corporate financials, insider reports, market indices, portfolio management systems, and data feeds. QuoteMedia provides industry leading market data solutions and financial services for companies such as the Nasdaq Stock Exchange, TMX Group (TSX Stock Exchange), Canadian Securities Exchange (CSE), London Stock Exchange Group, FIS, U.S. Bank, Bank of Montreal (BMO), Broadridge Financial Systems, JPMorgan Chase, Scotiabank, CI Financial, Canaccord Genuity Corp., Hilltop Securities, Avantax, Stockhouse, Zacks Investment Research, General Electric, Boeing, Bombardier, Telus International, Business Wire, PR Newswire, The Goldman Sachs Group, Regal Securities, ChoiceTrade, Cetera Financial Group, Dynamic Trend, Inc., Credential Qtrade Securities, CNW Group, iA Private Wealth, Ally Invest, Inc., Suncor, Leede Jones Gable, Firstrade Securities, Charles Schwab, First Financial, Equisolve, Stock-Trak, Mergent, Cision and others. Quotestream®, QMod™ and Quotestream Connect™ are trademarks of QuoteMedia. For more information, please visit www.quotemedia.com .
Statements about QuoteMedia’s future expectations, including future revenue, earnings, and transactions, as well as all other statements in this press release other than historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. QuoteMedia intends that such forward-looking statements be subject to the safe harbors created thereby. These statements involve risks and uncertainties that are identified from time to time in the Company’s SEC reports and filings and are subject to change at any time. QuoteMedia’s actual results and other corporate developments could differ materially from that which has been anticipated in such statements.
Below are the specific forward-looking statements included in this press release:
Moving forward, we expect to see an improvement in profitability as our professional fees normalize, and our revenue and gross margin percentages increase.
We believe that Adjusted EBITDA, as a non-GAAP pro forma financial measure, provides meaningful information to investors in terms of enhancing their understanding of our operating performance and results, as it allows investors to more easily compare our financial performance on a consistent basis compared to the prior year periods. This non-GAAP financial measure also corresponds with the way we expect investment analysts to evaluate and compare our results. Any non-GAAP pro forma financial measures should be considered only as supplements to, and not as substitutes for or in isolation from, or superior to, our other measures of financial information prepared in accordance with GAAP, such as net income attributable to QuoteMedia, Inc.
We define and calculate Adjusted EBITDA as net income attributable to QuoteMedia, Inc., plus: 1) depreciation and amortization, 2) stock compensation expense, 3) interest expense, 4) foreign exchange loss (or minus a foreign exchange gain), and 5) income tax expense. We disclose Adjusted EBITDA because we believe it is a useful metric by which to compare the performance of our business from period to period. We understand that measures similar to Adjusted EBITDA are broadly used by analysts, rating agencies, investors and financial institutions in assessing our performance. Accordingly, we believe that the presentation of Adjusted EBITDA provides useful information to investors. The table below provides a reconciliation of Adjusted EBITDA to net income attributable to QuoteMedia, Inc., the most directly comparable GAAP financial measure.
QuoteMedia, Inc. Adjusted EBITDA Reconciliation to Net Income:
$65+ million per year pace for new business awards continues
CHARLOTTE, N.C., April 08, 2024 (GLOBE NEWSWIRE) — NN, Inc. (NASDAQ: NNBR), a global diversified industrial company that engineers and manufactures high-precision components and assemblies, today announced another strong quarter of new business wins, with $17.2 million in new business awards in the first quarter of 2024. NN continued its momentum from the second half of 2023, consistent with the company’s 2024 target of $55-$70 million of new business awards. Additionally, over 70% of the Q1 2024 awards have an immediate startup in 2024.
“We are becoming a force to be reckoned with in our targeted market and product segments. We are very focused and have a progressive plan to learn fast and react fast to great opportunities that fit our strengths,” said Verlin Bush, Chief Commercial Officer of NN, Inc. “We have deep technical expertise in precision metal solutions, open capacity for many products and are moving quickly on new capabilities that fit our future direction. We intend to lead in our product categories and add additional avenues for growth. It’s an extremely exciting time to be in our industries as a value-added partner. This strong performance requires multi-functional teamwork amongst sales, engineering, operations and procurement. We are making it happen.”
NN secured 23 new business wins in the first quarter, averaging $700,000 each across its strategic regions in North America, South America, Europe and China. NN has formulated stronger programs in certain regions and is improving its sales mix by creating options for swap-outs and trade ups at certain plants. 72% of the awards startup in 2024; 3% in 2025 and 25% in 2026.
“Securing above-market profitable sales growth is a key pillar of our multi-year transformation plan. Our end markets are healthy with plenty of opportunities to participate at a higher rate,” said Harold Bevis, President and CEO of NN, Inc. “We are still optimizing some dilutive business at certain plants with certain customers, while at the same time adding new accretive business, and have been successful over the last three quarters. Already we are launching many new programs in parallel, while at the same time, rationalizing business at certain plants. Our operational performance is improving and giving us additional growth opportunities at certain plants where new business development had been constrained. We have a focused plan that is on track.”
NN’s notable wins were secured in target areas, including vehicle electrification and charging systems, fuel efficiency and greenhouse gas reduction solutions, electrical grid expansion and control, and orthopedic medical products. The company’s forward pipeline remains focused and robust, with $610 million of potential new business.
About NN, Inc. NN, Inc., a global diversified industrial company, combines advanced engineering and production capabilities with in-depth materials science expertise to design and manufacture high-precision components and assemblies for a variety of markets on a global basis. Headquartered in Charlotte, North Carolina, NN has facilities in North America, Europe, South America, and Asia. For more information about the company and its products, please visit www.nninc.com.
FORWARD-LOOKING STATEMENTS
Except for specific historical information, many of the matters discussed in this press release may express or imply projections of revenues or expenditures, statements of plans and objectives or future operations or statements of future economic performance. These statements may discuss goals, intentions and expectations as to future trends, plans, events, results of operations or financial condition, or state other information relating to NN, Inc. based on current beliefs of management as well as assumptions made by, and information currently available to, management. Forward-looking statements generally will be accompanied by words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “guidance,” “intend,” “may,” “possible,” “potential,” “predict,” “project” or other similar words, phrases or expressions. Forward-looking statements involve a number of risks and uncertainties that are outside of management’s control and that may cause actual results to be materially different from such forward-looking statements. Such factors include, among others, general economic conditions and economic conditions in the industrial sector; the impacts of pandemics, epidemics, disease outbreaks and other public health crises, including the COVID-19 pandemic, on our financial condition, business operations and liquidity; competitive influences; risks that current customers will commence or increase captive production; risks of capacity underutilization; quality issues; material changes in the costs and availability of raw materials; economic, social, political and geopolitical instability, currency fluctuation, and other risks of doing business outside of the United States; inflationary pressures and changes in the cost or availability of materials, supply chain shortages and disruptions, and the availability of labor; our dependence on certain major customers, some of whom are not parties to long-term agreements (and/or are terminable on short notice); the impact of acquisitions and divestitures; our ability to hire or retain key personnel; the level of our indebtedness; the restrictions contained in our debt agreements; our ability to obtain financing at favorable rates, if at all, and to refinance existing debt as it matures; unanticipated difficulties integrating acquisitions; new laws and governmental regulations; the impact of climate change on our operations; and cyber liability or potential liability for breaches of our or our service providers’ information technology systems or business operations disruptions. The foregoing factors should not be construed as exhaustive and should be read in conjunction with the sections entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in the Company’s filings made with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date of this press release, and the Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law. New risks and uncertainties may emerge from time to time, and it is not possible for the Company to predict their occurrence or how they will affect the Company. The Company qualifies all forward-looking statements by these cautionary statements.
