Month: May 2024

FAT Brands (FAT) – First Step To A Twin Peaks IPO

Posted on by cpereira@noblefcm.com


Wednesday, May 15, 2024

FAT Brands (NASDAQ: FAT) is a leading global franchising company that strategically acquires, markets, and develops fast casual, quick-service, casual dining, and polished casual dining concepts around the world. The Company currently owns 17 restaurant brands: Round Table Pizza, Fatburger, Marble Slab Creamery, Johnny Rockets, Fazoli’s, Twin Peaks, Great American Cookies, Hot Dog on a Stick, Buffalo’s Cafe & Express, Hurricane Grill & Wings, Pretzelmaker, Elevation Burger, Native Grill & Wings, Yalla Mediterranean and Ponderosa and Bonanza Steakhouses, and franchises and owns over 2,300 units worldwide. For more information on FAT Brands, please visit www.fatbrands.com.

Joe Gomes, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Filing. FAT Brands announced the operating unit for Twin Peaks (TP) and Smokey Bones (SB) confidentially submitted a registration statement to the SEC to become a standalone public reporting company. While timing and completion of an IPO of the units is subject to numerous conditions, this is a first step.

Confidential? The SEC permits issuers to submit draft registration statements relating to IPOs for review by the SEC staff on a confidential basis. The confidential submission process is intended to give issuers more flexibility to plan their offerings and reduce the potential for lengthy exposure to market fluctuations that can adversely affect an offering. It is our understanding that a confidential filing allows the issuer to defer the public disclosure of sensitive commercial and financial information.


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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*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. 

Century Lithium Corp. (CYDVF) – On the Path Leading to a Production Decision

Posted on by cpereira@noblefcm.com


Wednesday, May 15, 2024

Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Results of the Clayton Valley feasibility study. Century released the results of a feasibility study (FS) for its Clayton Valley lithium project in Nevada. A phased approach was adopted. Phase I and II mining rates of 7,500 tonnes per day and 15,000 tonnes per day, respectively, are maintained over five years each, while the Phase III mining rate of 22,500 tonnes per day is maintained for 30 years. The production plan reflects a life-of-mine average of 34,000 tonnes per year of battery grade lithium carbonate or 13,000 tonnes and 27,000 tonnes per year during Phase I and II, respectively, and 41,000 tonnes per year during Phase III.

Updating our financial model. We have assumed the mine begins commercial production in 2029. Our mining model is for the years 2029 through 2069. While our financial assumptions are detailed in the body of this report, our valuation is based on the present value of free cash flows, and we have used a discount rate of 8.0%. Our price target for the equity is C$3.25 per share or US$2.35 per share. In our view, the project’s low operating cost after sales of surplus sodium hydroxide is a key differentiator relative to other lithium projects.


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*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. 

Bitcoin Depot (BTM) – Planting the Seeds For Attractive Revenue Growth

Posted on by cpereira@noblefcm.com


Wednesday, May 15, 2024

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

A transitional quarter. The company reported Q1 revenue of $138.5 million, down 15% year over year, but beating our estimate of $134.7 million. Adj. EBITDA in the quarter was $4.9 million, higher than our estimate of $4.0 million. The results reflected redeployment of kiosks and lowered results in California due to unfavorable legislation. 

Favorable kiosk growth. We believe that the company is setting the stage for accelerated revenue and cash flow growth through the deployment of kiosks. In Q1, the company increased the number of deployed kiosks by roughly 700. Post Q1, the company announced the purchase of approximately 2,300 Bitcoin kiosks at a sizeable discount of roughly 50% per-kiosk. The purchase brings the number of kiosks owned by the company to over 10,000, of which 7,061 were deployed, as of the end of Q1. 


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*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. 

Jamie Dimon’s Candid Warning on U.S. Fiscal Deficit

Posted on by slightbourne@noblecapitalmarkets.com

In a recent interview, Jamie Dimon, the CEO of JPMorgan Chase, issued a stark warning to the United States regarding its fiscal deficit. Dimon’s stern warning has significant ramifications, not only for policymakers but also for investors closely monitoring economic trends and government policies that can influence market dynamics and investment strategies.

Dimon’s primary concern revolves around the rapid escalation of the fiscal deficit, which currently stands at a staggering 6% of the nation’s GDP. This surge is largely attributable to the extensive measures implemented during and after the COVID-19 pandemic, including interest rate hikes, tax cuts, and massive stimulus programs. While these actions were intended to buoy the economy during turbulent times, Dimon cautions that their long-term consequences, if not counterbalanced by fiscal discipline, could be detrimental.

A prominent issue highlighted by Dimon is the potential impact on inflation. Unchecked deficit spending can fuel higher inflation rates, eroding the purchasing power of investors and consumers alike. Inflation trends are closely watched by investors, as they can influence interest rates, asset prices, and overall investment strategies. Moreover, a ballooning deficit can signal underlying economic imbalances, potentially necessitating corrective measures in the future that could disrupt investment portfolios.

Moreover, Dimon’s remarks shed light on the broader economic outlook. A ballooning deficit can signal underlying economic imbalances and may necessitate corrective measures in the future. For investors, this underscores the importance of staying informed about macroeconomic indicators and government fiscal policies that can shape investment opportunities and risks.

Dimon’s call for addressing the deficit resonates with the broader theme of fiscal responsibility in investment strategies. Investors often seek opportunities in sectors or assets less vulnerable to fiscal uncertainties or inflationary pressures. Diversification across asset classes and regions can also mitigate risks associated with policy changes. Furthermore, Dimon’s commentary underscores the interplay between government policies and market dynamics, as policy decisions, such as deficit reduction efforts, can shape market sentiment, investor confidence, and long-term economic stability.

Furthermore, Dimon’s commentary touches on the relationship between government policies and market dynamics. Investors are mindful of how policy decisions, such as deficit reduction efforts, can influence market sentiment, investor confidence, and long-term economic stability. Understanding these interconnections is crucial for making informed investment decisions.

Beyond fiscal matters, Dimon’s advocacy for respectful dialogue and understanding across political divides is noteworthy. Political stability and consensus on economic policies can contribute to a favorable investment climate. Investors value predictability and clarity in policy frameworks, as they provide a foundation for long-term planning and investment allocation.

In conclusion, Jamie Dimon’s warning regarding the U.S. fiscal deficit carries significant implications for investors. It underscores the importance of fiscal responsibility, the potential impact on inflation and market dynamics, and the value of informed decision-making in navigating economic uncertainties. As investors evaluate opportunities and risks, staying attuned to developments in fiscal policy and economic trends will remain paramount in shaping investment strategies.

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Inflation Just Dropped a Massive Hint About the Fed’s Next Move

Posted on by slightbourne@noblecapitalmarkets.com

The major U.S. stock indexes inched up on Tuesday as investors digested mixed producer inflation data and turned their focus to the much-anticipated consumer price index report due out on Wednesday.

The producer price index (PPI) for April showed prices paid by businesses for inputs and supplies increased 0.2% from the prior month, slightly above economists’ expectations of 0.1%. On an annual basis, PPI rose 2.3%, decelerating from March’s 2.7% pace but still higher than forecasts.

The “hot” PPI print caused traders to dial back bets on an interest rate cut from the Federal Reserve at its September meeting. Fed funds futures showed only a 48% implied probability of a 25 basis point rate cut in September, down from around 60% before the report.

Speaking at a banking event in Amsterdam, Fed Chair Jerome Powell characterized the PPI report as more “mixed” than concerning since revisions showed prior months’ data was not as hot as initially reported. He reiterated that he does not expect the Fed’s next move to be a rate hike, based on the incoming economic data.

“My confidence [that inflation will fall] is not as high as it was…but it is more likely we hold the policy rate where it is [than raise rates further],” Powell stated.

Investors are now eagerly awaiting Wednesday’s consumer price index data as it will provide critical signals on whether upside inflation surprises in Q1 were just temporary blips or indicative of a more worrying trend.

Consensus estimates project headline CPI cooled to 5.5% year-over-year in April, down from 5.6% in March. Core CPI, which strips out volatile food and energy prices, is expected to moderate slightly to 5.5% from 5.6%.

If CPI comes in hotter than projected, it would solidify expectations that the Fed will likely forego rate cuts for several more months as it prioritizes restoring price stability over promoting further economic growth.

Conversely, cooler-than-forecast inflation could reinforce the narrative of slowing price pressures and clear the path for the Fed to start cutting rates as soon as June or July to provide a buffer against a potential economic downturn.

The benchmark S&P 500 index closed up 0.18% on Tuesday, while the tech-heavy Nasdaq gained 0.43%. Trading was choppy as investors bided their time ahead of the CPI release.

Market focus has intensified around each new inflation report in recent months as investors attempt to gauge when the Fed might pivot from its aggressive rate hike campaign of the past year.

With inflation still running well above the Fed’s 2% target and the labor market remaining resilient, most economists expect the central bank will need to keep rates elevated for some time to restore price stability. But the timing and magnitude of any forthcoming rate cuts is still hotly debated on Wall Street.

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The Shocking New Tech that Reads Your Mind!

Posted on by slightbourne@noblecapitalmarkets.com

As the world’s largest technology companies continually search for new avenues of innovation and growth, an unlikely field is rapidly emerging as the next major opportunity – neuroscience and the ability to interface directly with the human brain.

While the idea of mind-reading may sound like science fiction, recent breakthroughs powered by artificial intelligence have brought brain-computer interfaces into reality. And the tech giants are taking notice, pouring hundreds of millions into developing these neurotechnologies with an eye on future ecosystems and revenue streams.

A $55 Billion Neurotechnology Gold Rush
According to market research firm Precedence, the global neurotechnology market was valued at around $15 billion in 2023. However, it’s projected to skyrocket to over $55 billion by 2032 as medical applications come to market and consumer use cases emerge.

This rapidly expanding opportunity has kicked off a modern-day gold rush as deep-pocketed companies like Meta, Apple, Amazon, Microsoft, and even Elon Musk’s Neuralink race to stake their claims.

In the medical field, brain-computer interface (BCI) devices that translate neural signals into digital commands are already helping patients with conditions like ALS, strokes, and paralysis to communicate and regain mobility.

But for Big Tech, the true prize lies in developing non-invasive consumer neurotechnology that can seamlessly integrate with devices and software – unlocking new frontiers in computing, gaming, virtual reality, and beyond.

Apple is exploring EEG sensors in AirPods that could monitor a user’s brain waves and mental state. Meta has a team working to decode human perception, using AI to reconstruct images just from people’s neural activity. And Amazon’s Alexa team is researching how to interpret brainwaves for voice-less voice control.

Even video game companies like Activision are eyeing the potential of neural interfaces that could immerse players’ minds directly into virtual environments.

Inside the Mind-Reading Moonshot
While the underlying BCI technology has existed for decades, the rise of advanced AI and machine learning capabilities is what’s truly catalyzing the mind-reading revolution.

By applying powerful neural networks to massive troves of brain signal data, companies aim to identify patterns that can then be translated into computer inputs for controls, communication, or even digital representations of sensory experiences like images and sound.

“We’re just scratching the surface of what neurotechnology combined with AI could enable,” said Dr. Lucy Green, a leading neuroscience researcher at Stanford University. “We may eventually be able to beam our thoughts directly into virtual spaces or machines, and create ultra-personalized experiences based on someone’s unique neural fingerprint.”

Naturally, such godlike capabilities raise serious ethical concerns around data privacy and consent. But for now, Green notes most development is still confined to medical use cases explicitly approved by patients.

Investment Opportunities Galore
For investors, the neurotechnology gold rush presents a multitude of intriguing opportunities across sectors. This includes established healthcare companies like Medtronic working on implantable BCIs, cutting-edge startups pioneering new interfaces and AI models, and even Big Tech bets on developing the next paradigm of human-machine interaction.

According to investment firm Ark, the entire “brain-computer interface” category could scale into a multi-trillion dollar annual revenue opportunity by 2030 if the technology meets its potential.

“It’s such a massive emerging space that will encompass hardware, software, AI capabilities, cloud computing, and likely subscription revenue streams,” said Ark analyst Nick Grous. “Any company that can establish an early lead could be looking at platform ownership.”

While the neuro-revolutions is still in its earliest innings, big bets are already being made behind the scenes at the world’s tech titans. For investors willing to grab a golden neural spike, it may represent one of the final frontiers of monetizing the human experience itself.

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Release – Tonix Pharmaceuticals Reports First Quarter 2024 Financial Results and Operational Highlights

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

May 13, 2024 4:30pm EDT

On track to submit NDA in the second half of 2024 for Tonmya™ for fibromyalgia; pre-NDA meeting with FDA scheduled for second quarter 2024

Commercial planning continues for U.S. launch of Tonmya, a potential new first-line, centrally-acting, non-opioid analgesic for the management of fibromyalgia

CHATHAM, N.J., May 13, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced financial results for the first quarter ended March 31, 2024, and provided an overview of recent operational highlights.

“Our near-term priority continues to be the submission of our New Drug Application (NDA) for Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia, while continuing to build out our commercial strategy for the anticipated product launch in the event of FDA approval, which we currently estimate to occur in the second half of 2025,” said Seth Lederman, M.D., Chief Executive Officer of Tonix.

Dr. Lederman added, “The well-known treatment-limiting side effects of the three currently approved drugs have led to widespread patient dissatisfaction, creating what we believe is a significant opportunity for a new therapeutic. Tonmya has a differentiated mechanism of action and is generally free of common side effects associated with the currently approved products, including weight gain, fatigue, insomnia, increased blood pressure, gastrointestinal issues or sexual dysfunction. As such, we believe Tonmya, if approved, could become the treatment of choice for the approximately 10 million people in the U.S. suffering the debilitating effects of fibromyalgia.”

The Company is also advancing other key pipeline programs including those for immunology, obesity, eating disorders, infectious and rare diseases, many through a capital efficient strategy involving partnerships, grants and in-kind contributions.

Recent Highlights – Key Product Candidates*

Central Nervous System (CNS) Pipeline

Tonmya (also known as TNX-102 SL; cyclobenzaprine HCl sublingual tablets): a centrally-acting, non-opioid, small molecule analgesic taken once-daily at bedtime for the management of fibromyalgia (FM).

  • In January 2024, Tonix presented additional safety and tolerability data from the pivotal Phase 3 RESILIENT study that showed Tonmya treatment was not associated with increases in systolic or diastolic blood pressure or body weight, nor were there any reported sexual side effects. The Company had previously announced in December 2023 that the Phase 3 RESILIENT study, a registration-quality, double-blind, placebo-controlled study evaluating Tonyma met its pre-specified primary endpoint in the second of two positive Phase 3 clinical trials, significantly reducing daily pain compared to placebo (p-value=0.00005) in participants with fibromyalgia. Statistically significant and clinically meaningful results were also seen in all pre-specified key secondary endpoints including those related to improving sleep quality, reducing fatigue, and improving patient global ratings and overall fibromyalgia symptoms and function. Tonmya was well tolerated with an adverse event profile comparable to prior studies and no new safety signals observed. In addition, Tonmya therapy showed activity on improving female sexual function relative to placebo with a nominal p-value=0.010 by the Changes in Sexual Functioning Questionnaire short-form, female version.
  • Tonix plans to submit an NDA to the FDA in the second half of 2024 for Tonmya for the management of fibromyalgia. In February 2024, Tonix announced the engagement of Rho, Inc. as our contract research organization (CRO) to support NDA submission.
  • In February 2024, Tonix announced statistically significant results from its clinical pharmacokinetic (PK) bridging study of Tonmya in healthy adult male and female ethnic Japanese and Chinese volunteers. Results indicate that key PK parameters of cyclobenzaprine are comparable in ethnic Japanese and Chinese volunteers to Caucasian volunteers from a prior PK study. Tonmya was generally well tolerated in the ethnic Japanese and Chinese healthy volunteers. The company expects these data to fulfill the requirement for a bridging study, and enables Tonix to rely on Phase 3 studies RESILIENT and RELIEF results to support regulatory filings for clinical studies in Japan and China where cyclobenzaprine is a new chemical entity (NCE). Tonix holds issued patents for market exclusivity rights of Tonmya in Japan, China, Hong Kong and Taiwan.
  • In March 2024, Tonix announced the selection of two contract manufacturing organizations (CMOs), including Almac Pharma Services, as dual supply sources for the potential launch and commercialization of Tonmya in the U.S.
  • In March 2024, Tonix selected EVERSANA, a leading provider of commercialization services to the global life sciences industry, to support the launch strategy and commercial planning of Tonmya in the U.S.
  • Tonix presented additional efficacy data from RESILIENT at the 6th International Congress on Controversies in Fibromyalgia in Brussels, Belgium, March 7-8, 2024. The data showed that Tonmya treatment resulted in an improvement in cognitive dysfunction, or ‘brain fog’, measured by the change in the Fibromyalgia Impact Questionnaire-Revised (FIQ-R) memory item. The FIQ-R cognitive item showed nominal improvement in Tonmya-treated patients vs placebo-treated patients with a nominal p-value=0.001 and effect size of 0.31.

TNX-102 SL for the treatment of acute stress reaction (ASR) and acute stress disorder (ASD), and prophylaxis against development of posttraumatic stress disorder (PTSD)

  • In February 2024, the Company announced the FDA cleared the Investigational New Drug (IND) application for the Phase 2 investigator-initiated OASIS trial to evaluate TNX-102 SL in reducing the severity of ASR and the frequency of ASD and PTSD. The trial is sponsored by the University of North Carolina Institute for Trauma Recovery and supported by a $3 million grant from the U.S. Department of Defense, which was awarded in September 2023. The proposed Phase 2, Optimizing Acute Stress Reaction Interventions with TNX-102 SL (OASIS) study will examine the safety and efficacy of TNX-102 SL to reduce adverse posttraumatic neuropsychiatric sequelae among patients presenting to the emergency department (ED) after a motor vehicle collision. The study will enroll approximately 180 trauma survivors at ED study sites in the U.S. Participants will be randomized in the ED to receive a two-week course of either TNX-102 SL 5.6 mg or placebo.
  • Tonix anticipates the Phase 2 OASIS trial will initiate in the second quarter of 2024.

TNX-102 SL for the treatment of Fibromyalgia-Type Long COVID, also known as Post-Acute Sequelae of COVID-19 (PASC)

  • In January 2024, the Company announced the online publication of a research paper in the Journal Pain. The article titled, “Chronic Overlapping Pain Conditions Increase the Risk of Long COVID Features, Regardless of Acute COVID Status,” by Bergmans, et al.1, found that patients with pre-existing chronic overlapping pain conditions (COPCs) had an increased risk of being diagnosed with symptoms of Long COVID1. Faculty at the University of Michigan directed the research. Commentary on the article titled, “A step towards better understanding chronic overlapping pain conditions” by Fitzcharles, et al,2 is in the same issue of the journal. COPCs include fibromyalgia, chronic fatigue syndrome, migraine headache, irritable bowel syndrome, endometriosis and low back pain. These results contribute to a growing body of evidence that common symptoms of Long COVID in many patients are at least partly driven by central nervous system mechanisms.

TNX-1300 (recombinant double mutant cocaine esterase): biologic for life-threatening cocaine intoxication

  • Tonix expects to initiate a Phase 2 clinical study of TNX-1300 for the treatment of cocaine intoxication in emergency rooms in the second quarter of 2024. In 2022, Tonix was awarded a Cooperative Agreement grant from the National Institutes of Health (NIH)’s National Institute of Drug Abuse (NIDA) to support development of TNX-1300.
  • TNX-1300 has been granted Breakthrough Therapy designation by the FDA.

TNX-1900 (intranasal potentiated oxytocin): small peptide in development through investigator-initiated studies for adolescent obesity, binge eating disorder, bone health in autism and social anxiety disorder (SAD).

  • TNX-1900 continues to be studied in four ongoing investigator-initiated Phase 2 studies as follows: Massachusetts General Hospital (MGH): (1) Phase 2 study for binge-eating disorder (BED); (2) Phase 2 study for adolescent obesity; (3) Phase 2 study for improving bone health in children with autism spectrum disorder (BOX); and at University of Washington, (4) Phase 2 study for social anxiety disorder (SAD). The BED study and the adolescent obesity study will investigate whether TNX-1900 has effects on eating behaviors in specialized populations.

Rare Disease Pipeline

TNX-2900 (intranasal potentiated oxytocin): small peptide for the treatment of Prader-Willi syndrome (PWS)

  • In March 2024, Tonix announced that it received Rare Pediatric Disease designation from the FDA for TNX-2900 for the treatment of PWS. Tonix has an IND to support clinical development of TNX-2900 to treat PWS in children and adolescents. The planned Phase 2 study is a dose-finding study involving approximately 36 PWS patients divided into four groups with approximately nine per group. One group will receive placebo and three groups will receive different dosage regimens of TNX-2900. TNX-2900 for the treatment of PWS was granted Orphan Drug designation by the FDA in 2022. PWS is a genetic disorder that affects several body systems, with cognitive and behavioral symptoms including pathological over-eating beginning in childhood and leading to severe metabolic sequelae.

Immunology Pipeline

TNX-1500 (anti-CD40L Fc-modified humanized monoclonal antibody): third generation anti-CD40L monoclonal antibody for prophylaxis of organ transplant rejection and treatment of autoimmune disorders.

  • The first proposed indication for TNX-1500 is prophylaxis of organ rejection in adult patients receiving a kidney transplant; but multiple additional indications are possible, including autoimmune diseases. Two peer reviewed publications described the work with TNX-1500 at the Massachusetts General Hospital (MGH) on allogeneic transplants in animals.3,4
  • Preclinical studies have shown that TNX-1500 maintains the activity of first-generation monoclonal antibodies (mAbs), yet with reduced risk of thrombotic complications.3-5 Modeling studies from animal pharmacokinetic data3 predict a half-life of greater than three weeks for TNX-1500 in humans, which supports a monthly i.v. dosing regimen. This analysis together with TNX-1500’s activity and tolerability in animals, suggests that the protein engineering of TNX-1500’s Fc region has achieved its design goals.
  • In February 2024, Tonix announced the completion of the clinical stage of its Phase 1 single ascending dose study of TNX-1500 in healthy volunteers. The primary objectives of the study are to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of intravenous TNX-1500. This first-in-human study is intended to support dosing in a planned Phase 2 trial in kidney transplant recipients.
  • In March of 2024, the MGH announced the first transplant of a genetically modified pig kidney into a living patient in collaboration with eGenesis, which produced the pig donors and used an anti-CD40L mAb from another company.5 Some of the pre-clinical work that supported the living human transplant was performed in collaboration with Tonix and used TNX-1500.6 The patient was able to return home after the transplant, but died after approximately two months.7

Marketed Products – Recent Highlights

  • As of April 1, 2024, Tonix completed the transition to becoming a fully integrated pharmaceutical company. Tonix Pharmaceuticals has implemented personnel, systems and contracts required to support a commercial organization and has assumed responsibility for distribution, selling and marketing of Zembrace SymTouch and Tosymra, as well as supply chain, regulatory and quality control of the two products.

Facilities – Recent Highlights

  • In the fourth quarter of 2023, Tonix engaged CBRE, an international real estate brokerage firm, to potentially find a strategic partner for, or buyer of, its Advanced Development Center (ADC) to align with the Company’s current business objectives and priorities. At this time, the Company does not have a commitment in place to sell the building. ADC, located in the New Bedford business park in Dartmouth, Massachusetts, is an approximately 45,000 square foot BSL-2 facility intended for clinical scale manufacturing of live-virus vaccines and biologics.

*All of Tonix’s product candidates are investigational new drugs or biologics and none have been approved for any indication.

Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.

1 Bergmans RS, et al. PAIN. 2023. DOI: 10.1097/j.pain.0000000000003110.

2 Fitzcharles M-A, et al. PAIN. 2023. DOI: 10.1097/j.pain.0000000000003129.

3 Lassiter G., et al. Am J Transplantation. 2023. https://doi.org/10.1016/j.ajt.2023.03.022

4 Miura S., et al. Am J Transplantation. 2023. https://doi.org/10.1016/j.ajt.2023.03.025

5 Massachusetts General Hospital press release. March 21, 2024. “World’s First Genetically Edited Pig Kidney Transplant into Living Recipient Performed at Massachusetts General Hospital.” www.massgeneral.org/news/press-release/worlds-first-genetically-edited-pig-kidney-transplant-into-living-recipient (accessed March 29, 2024)

6 Anand, R.P., et al Nature. 622, 393–401 (2023). https://doi.org/10.1038/s41586-023-06594-4

7 Stoico, N. Boston Globe. May 11, 2023. “Mass Man who received first kidney transplant from genetically engineered pig has died, family says”.

Recent Highlights – Financial

As of March 31, 2024, Tonix had $7.0 million of cash and cash equivalents, compared to $24.9 million as of December 31, 2023. Net cash used in operations was approximately $17.6 million for first quarter 2024, compared to net cash used in operations of $32.9 million for the same period in 2023.

On April 1, 2024, the Company closed a financing with existing healthcare-focused institutional investors for upfront gross proceeds of approximately $4.4 million through a registered direct offering. 

First Quarter 2024 Financial Results

Net product revenue for the first quarter 2024 was approximately $2.5 million. Net product revenue consisted of combined net sales of Zembrace® SymTouch® and Tosymra®, which were acquired from Upsher-Smith Laboratories, LLC on June 30, 2023. Cost of Sales for the first quarter 2024 was approximately $1.7 million.

Research and development expenses for the first quarter 2024 were $12.9 million, compared to $26.5 million for the same period in 2023. This decrease is predominantly due to decreased clinical, non-clinical and manufacturing expenses.

General and administrative expenses for the first quarter 2024 were $9.3 million, compared to $7.4 million for the same period in 2023. The increase was primarily due to sales and marketing and the transition services expenses associated with the Company’s recently acquired marketed products offset by a decrease in financial reporting expenses.

Net loss was $(14.9) million, or $(0.18) per share, basic and diluted, for the first quarter 2024, compared to net loss of $(33.0) million, or $(3.21) per share, basic and diluted, for the same period in 2023. The basic and diluted weighted average common shares outstanding for the first quarter 2024 was 80,879,108 compared to 10,268,500 shares for the same period in 2023.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya1, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.

1Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

View full release here.

Investor Contact

Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Media Contact

Katie Dodge
LaVoieHealthScience
kdodge@lavoiehealthscience.com
(978) 360-3151

Release – QuoteMedia Announces Financial Results for Q1 2024

Posted on by aweinsoff@channelchek.com

Research News and Market Data on QMCI

PHOENIX, May 13, 2024 (GLOBE NEWSWIRE) — QuoteMedia, Inc. (OTCQB: QMCI), a leading provider of market data and financial applications, announced financial results for the quarter ended March 31, 2024.

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 Q1 2024 include the following:

  • Quarterly revenue decreased by $70,848 (1%) to $4,679,200 in Q1 2024 from $4,750,048 in 2023.
  • Adjusted EBITDA for Q1 2024 was $676,886 compared to $829,585 in Q1 2023, a reduction of $152,699.
  • Our net loss for Q1 2024 was $28,176 compared to net income of $113,290 in Q1 2023, a decrease in profitability of $141,466.

“This was a challenging quarter for QuoteMedia,” said Robert J. Thompson, Chairman of the Board. “Economic conditions forced a few clients to reduce or discontinue their spending with QuoteMedia, offsetting the revenue from new clients added during the quarter. There are, however, several exciting prospective clients in the pipeline. While the sales cycles for these large-scale deployments can be quite long, we expect to see improved revenue growth as the year progresses.”

QuoteMedia will host a conference call Tuesday, May 14, 2024, at 2:00 PM Eastern Time to discuss the Q1 2024 financial results and provide a business update.

Conference Call Details:

Date: May 14, 2024

Time: 2:00 PM Eastern Time

Dial-in number: 888-632-3384; 785-424-1794

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. QuoteMediaprovides 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, IEX Data Services LLC, U.S. Bank, Bank of Montreal (BMO), Broadridge Financial Systems, JPMorgan Chase, Scotiabank, CI Financial, Canaccord Genuity Corp., Hilltop Securities, Avantax, Zacks Investment Research, S&P Global Market Intelligence Inc., Business Wire, Cision (PR Newswire, CNW Group), The Goldman Sachs Group, TheStreet.com, Motley Fool, Regal Securities, ChoiceTrade, Cetera Financial Group, Dynamic Trend, Inc., Aviso Financial Inc., iA Private Wealth, Leede Jones Gable, Firstrade Securities, Charles Schwab, Lightspeed Financial Services Group LLC, Equisolve, Stock-Trak and others. Quotestream®, QMod TM and Quotestream Connect TM 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:

  • There are, however, several exciting prospective clients in the pipeline. While the sales cycles for these large-scale deployments can be quite long, we expect to see improved revenue growth as the year progresses.

QuoteMedia Investor Relations

Brendan Hopkins
Email: investors@quotemedia.com
Call: (407) 645-5295

Note 1 on Non-GAAP Financial Measures

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:

Three-months ended March 31,20242023
Net (loss) income$(28,176)$113,290
Depreciation and amortization728,678627,987
Stock-based compensation–78,125
Interest expense9531,452
Foreign exchange (loss) gain(25,307)8,001
Income tax expense738730
Adjusted EBITDA$676,886$829,585

News Provided by GlobeNewswire via QuoteMedia

Release – Ocugen Provides Business Update With First Quarter 2024 Financial Results

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

May 14, 2024

PDF Version

CONFERENCE CALL AND WEBCAST TODAY AT 8:30 A.M. ET

  • All three first-in-class modifier gene therapy product candidates currently in the clinic with OCU400 Phase 3 in progress
  • OCU400 on track to meet 2026 Biologics License Application (BLA) and Market Authorization Application (MAA) approval targets

MALVERN, Pa., May 14, 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 reported first quarter 2024 financial results along with a general business update.

“We’ve experienced several important clinical and regulatory milestones since the beginning of 2024 that we believe are leading the way to a new treatment paradigm for patients with blindness diseases,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen. “It’s very encouraging to have FDA clearance and EMA support for the Phase 3 clinical trial of our lead modifier gene therapy candidate that offers a potential one-time treatment for life.”

With FDA clearance to begin the Phase 3 liMeliGhT clinical trial, OCU400 becomes the first gene therapy to progress to late-stage trials with a broad retinitis pigmentosa (RP) indication. Until now, there has been only one marketed product to treat one of the 100 gene mutations associated with RP. The gene-agnostic mechanism of action for OCU400 provides hope for a much larger RP patient population. In the U.S. and Europe combined, RP affects nearly 300,000 people.

Ocugen expects to begin dosing patients in the Phase 3 liMeliGhT clinical trial in the second quarter of 2024. The Phase 3 trial will have a sample size of 150 participants—one arm of 75 participants with the RHO gene mutation and the other arm with 75 participants that are gene-agnostic. Luminance Dependent Navigation Assessment (LDNA) is the primary endpoint for the study and focuses on the proportion of responders, in treated and untreated groups, achieving an improvement of at least 2 Lux levels from baseline in the study eyes.

Leveraging a dual-track strategy, the Company plans to expand the Phase 3 OCU400 clinical trial in the second half of 2024 to include patients with Leber congenital amaurosis (LCA), contingent on favorable results from the Phase 1/2 study.

Modifier gene therapy has the potential to treat inherited retinal diseases as well as multifactorial blindness diseases affecting millions of patients. Leveraging the nuclear receptor gene RAR-related orphan receptor A (RORA), OCU410 is designed to regulate all four pathways involved with dry age-related macular degeneration (dAMD)—including lipid metabolism, inflammation, oxidative stress, and membrane attack complex (complement). Ocugen is developing OCU410 as a one-time gene therapy for the treatment of geographic atrophy (GA), an advanced stage of dAMD, affecting 2-3 million people in the U.S. and Europe combined. OCU410ST is being developed as a one-time gene therapy for the treatment of Stargardt disease, affecting approximately 100,000 people in the U.S. and Europe combined.

In April, dosing was completed in the second cohort (medium dose) of the Phase 1/2 ArMaDa clinical trial for OCU410. Dosing in the first cohort (low dose) of the Phase 1/2 GARDian trial for OCU410ST was completed earlier in the first quarter and in April 2024, the Data Safety and Monitoring Board approved the continuation to cohort 2 (medium dose).

“Our efforts in the first quarter of the year evidence the importance of our gene therapy programs and the need to operate the business to ensure their success,” said Dr. Musunuri. “We are opportunistic about Ocugen’s cell therapy and vaccine platforms, knowing that these technologies have great therapeutic and financial potential and are pursuing partnerships to support our entire pipeline.”

Ophthalmic Gene Therapies —First-in-class

  • OCU400—Received FDA clearance of IND amendment to initiate OCU400 Phase 3 liMeliGhT clinical trial in RP. EMA provided acceptability of the U.S.-based trial for submission of Marketing Authorization Application (MAA). Currently, the multi-center Phase 3 clinical trial is in progress.
  • OCU410 – Currently in Phase 1/2 stage of clinical development with active patient enrollment. Dosing is complete in the second cohort (medium dose) in the dose-escalation phase of the study. Once the third cohort (high dose) is complete, the Company will move into the Phase 2 clinical trial—the expansion phase—in the third quarter of 2024.
  • OCU410ST – Currently in Phase 1/2 stage of clinical development with active patient enrollment. Dosing is complete for cohort 1 (low dose). Initiated enrollment in cohort 2 (medium dose) in the dose-escalation phase of the trial.

Regenerative Cell Therapies—First-in-class

  • NeoCart® – Completed renovating an existing facility into a current Good Manufacturing Practice (“GMP”) facility in accordance with the FDA’s regulations. Intend to initiate the Phase 3 trial, contingent on adequate availability of funding.

Vaccines Portfolio—First-in-class

  • Mucosal Vaccine Platform – NIAID is collaborating with Ocugen on clinical development of OCU500. Planning to submit IND by mid-2024 to initiate Phase 1 clinical trial.

Biologics

  • OCU200—Continue to work with FDA to address comments to lift the clinical hold.

First Quarter 2024 Financial Results

  • The Company’s cash and cash equivalents totaled $26.4 million as of March 31, 2024, compared to $39.5 million as of December 31, 2023. The Company had 257.3 million shares of common stock outstanding as of March 31, 2024.
  • Total operating expenses for the three months ended March 31, 2024 were $13.2 million and included research and development expenses of $6.8 million and general and administrative expenses of $6.4 million. This compares to total operating expenses for the three months ended March 31, 2023 of $18.5 million that included research and development expenses of $10.2 million and general and administrative expenses of $8.3 million.
  • Ocugen reported a $0.05 net loss per common share for the three months ended March 31, 2024 compared to a $0.08 net loss per common share for the three months ended March 31, 2023.

Conference Call and Webcast Details

Ocugen has scheduled a conference call and webcast for 8:30 a.m. ET today to discuss the financial results and recent business highlights. Ocugen’s senior management team will host the call, which will be open to all listeners. There will also be a question-and-answer session following the prepared remarks.

Attendees are invited to participate on the call or webcast using the following details:

Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers
Conference ID: 8699924
Webcast: Available on the events section of the Ocugen investor site

A replay of the call and archived webcast will be available for approximately 45 days following the event on the Ocugen investor site.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on X and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, strategy, business plans and objectives for Ocugen’s clinical programs, plans and timelines for the preclinical and clinical development of Ocugen’s product candidates, including the therapeutic potential, clinical benefits and safety thereof, expectations regarding timing, success and data announcements of current ongoing preclinical and clinical trials, the ability to initiate new clinical programs; Ocugen’s financial condition, 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 annual and periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
Head of Communications
IR@ocugen.com

View full release here.

Release – Lifeway Foods® Announces Record Results for the First Quarter Ended March 31, 2024

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on LWAY

Net sales of $44.6 million; up 17.8% year-over-year driven by volume growth of Lifeway Kefir

18th consecutive quarter of year-over-year growth

Delivers 410 basis points of gross profit margin expansion

MORTON GROVE, Ill., May 14, 2024 /PRNewswire/ — Lifeway Foods, Inc. (Nasdaq: LWAY) (“Lifeway” or “the Company”), a leading U.S. supplier of kefir and fermented probiotic products to support the microbiome, today reported financial results for the first quarter ended March 31, 2024.

“Following our tremendous results in 2023, I am thrilled to report yet another record-breaking quarter on the topline to kick off 2024,” commented Julie Smolyansky, President and Chief Executive Officer of Lifeway Foods. “Driven by volume growth in our flagship Lifeway drinkable kefir, we delivered our highest ever quarterly net sales of $44.6 million in the first quarter, up nearly 18% year-over-year, as our strategic sales and marketing investments continue to accelerate our sales velocities, grow awareness and win new consumers seeking better-for-you, premium products at a great value. This marked our 18th consecutive quarter of growth and 4th consecutive quarter reporting record net sales, which demonstrates the loyalty of our core customer base. Through our strong operational execution, accompanied by favorable transportation cost tailwinds, we also continued to improve on our key profitability metrics in the quarter, highlighted by our gross margin expansion and net income growth. We are pleased with this strong start to the year, and are consistently evaluating additional brand marketing and incremental distribution opportunities in an effort to build on this high bar of success throughout 2024.”

First Quarter 2024 Results

Net sales were $44.6 million for the first quarter ended March 31, 2024, an increase of $6.7 million or 17.8% from the same period in 2023. The net sales increase was primarily driven by higher volumes of our branded drinkable kefir.

Gross profit as a percentage of net sales increased to 25.8% for the first quarter ended March 31, 2024 from 21.7% during the same period in 2023. The 410-basis point increase versus the prior year was primarily due to the higher volumes of Lifeway branded products, and to a lesser extent a favorable impact of transportation costs.

Selling, general and administrative expenses as a percentage of net sales were 17.6% for the first quarter ended March 31, 2024 and 2023, respectively.

The Company reported net income of $2.4 million or $0.17 per basic and $0.16 per diluted common share for the first quarter ended March 31, 2024 compared to net income of $0.8 million or $0.06 per basic and diluted common share during the same period in 2023.

Conference Call and Webcast
A pre-recorded conference call and webcast with Julie Smolyansky discussing these results with additional comments and details is available through the “Investor Relations” section of the Company’s website at https://lifewaykefir.com/webinars-reports/  and will also be available for replay.

About Lifeway Foods, Inc.
Lifeway Foods, Inc., which has been recognized as one of Forbes’ Best Small Companies, is America’s leading supplier of the probiotic, fermented beverage known as kefir. In addition to its line of drinkable kefir, the company also produces a variety of cheeses and a ProBugs line for kids. Lifeway’s tart and tangy fermented dairy products are now sold across the United States, Mexico, Ireland and France. Learn how Lifeway is good for more than just you at lifewayfoods.com.

Forward-Looking Statements

This release (and oral statements made regarding the subjects of this release) contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, future operating and financial performance, product development, market position, business strategy and objectives. These statements use words, and variations of words, such as “continue,” “build,” “future,” “increase,” “drive,” “believe,” “look,” “ahead,” “confident,” “deliver,” “outlook,” “expect,” and “predict.” Other examples of forward-looking statements may include, but are not limited to, (i) statements of Company plans and objectives, including the introduction of new products, or estimates or predictions of actions by customers or suppliers, (ii) statements of future economic performance, and (III) statements of assumptions underlying other statements and statements about Lifeway or its business. You are cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events and thus are inherently subject to uncertainty. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from Lifeway’s expectations and projections. These risks, uncertainties, and other factors include: price competition; the decisions of customers or consumers; the actions of competitors; changes in the pricing of commodities; the effects of government regulation; possible delays in the introduction of new products; and customer acceptance of products and services. A further list and description of these risks, uncertainties, and other factors can be found in Lifeway’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and the Company’s subsequent filings with the SEC. Copies of these filings are available online at https://www.sec.gov, http://lifewaykefir.com/investor-relations/, or on request from Lifeway. Information in this release is as of the dates and time periods indicated herein, and Lifeway does not undertake to update any of the information contained in these materials, except as required by law. Accordingly, YOU SHOULD NOT RELY ON THE ACCURACY OF ANY OF THE STATEMENTS OR OTHER INFORMATION CONTAINED IN ANY ARCHIVED PRESS RELEASE.

Media:
Derek Miller 
Vice President of Communications, Lifeway Foods
Email: derekm@lifeway.net 

General inquiries:
Lifeway Foods, Inc.
Phone: 847-967-1010
Email: info@lifeway.net

Click Here for Full Report

Release – Bitcoin Depot Reports First Quarter 2024 Financial Results

Posted on by aweinsoff@channelchek.com

Research News and Market Data on BTM

May 14, 2024 8:05 AM EDT

Related Documents

Earnings Webcast

AUDIO

Strengthens Footprint with Over 2,000 New Retail Locations Signed in the First Quarter of 2024

Committed to Acquire Approximately 3,200 Additional Kiosks Year-to-Date to Support Expansion Strategy

Remains on Track to Deploy 8,000 Kiosks by the End of 2024

ATLANTA, May 14, 2024 (GLOBE NEWSWIRE) — Bitcoin Depot Inc. (“Bitcoin Depot” or the “Company”), a U.S.-based Bitcoin ATM operator and leading fintech company, today reported financial results for the first quarter ended March 31, 2024. Bitcoin Depot will host a conference call and webcast at 10:00 a.m. ET today. An earnings presentation and link to the webcast will be made available at ir.bitcoindepot.com.

“Bitcoin Depot’s momentum continued in the first quarter as we fortified our industry-leading market share, expanded our footprint to new geographies, and purchased thousands of kiosks for our future growth plans,” said Brandon Mintz, CEO and Founder of Bitcoin Depot. “We plan to continue our expansion of our total operating fleet size and are on track to reach our goal of 8,000 Bitcoin ATMs installed by the end of 2024 ahead of schedule after signing over 2,000 new retail locations during the first quarter. Our strategic expansion into Puerto Rico and Australia marks a significant step toward our goal of bringing Bitcoin to the masses and establishing a market-leading presence outside of North America. Looking ahead, we remain well-positioned to execute our strategic goals this year as the world’s leading Bitcoin ATM network while continuing to optimize the business for maximum profitability ahead.”

First Quarter 2024 Financial Results

Revenue in the first quarter of 2024 was $138.5 million, down 15% from $163.6 million in the first quarter of 2023.

Gross Profit in the first quarter of 2024 was $14.4 million, down 26% from $19.5 million for the first quarter of 2023. Gross Profit margin in the first quarter of 2024 was 10.4% compared to 11.9% in the first quarter of 2023.

Total operating expenses were $16.6 million for the first quarter of 2024, compared to $13.6 million for the first quarter of 2023. 

Net loss for the first quarter of 2024 was $4.2 million, compared to net income of $6.1 million for the first quarter of 2023.

Adjusted EBITDA, a non-GAAP measure, in the first quarter of 2024 was $4.9 million, compared to Adjusted EBITDA of $13.6 million for the first quarter of 2023. Please see “Explanation and Reconciliation of Non-GAAP Financial Measures” below.

Trailing Twelve Months Ended March 31, 2024

Revenue during the trailing twelve months ended March 31, 2024 was $663.9 million, up 1% from $655.9 million compared to the twelve months ended March 31, 2023.

Gross Profit in the twelve months ended March 31, 2024 was $83.4 million, up 29% from $64.6 million compared to the twelve months ended March 31, 2023. Gross Profit margin in the twelve months ended March 31, 2024 was 12.6% compared to 9.8% in the twelve months ended March 31, 2023.

Total operating expenses were $73.5 million for the twelve months ended March 31, 2024, compared to $56.9 million for the twelve months ended March 31, 2023. 

Net loss for the twelve months ended March 31, 2024 was $8.8 million, compared to net income of $13.0 million for the twelve months ended March 31, 2023.

Adjusted EBITDA, a non-GAAP measure, in the twelve months ended March 31, 2024 was $47.6 million, compared to Adjusted EBITDA of $49.5 million for the twelve months ended March 31, 2023. Please see “Explanation and Reconciliation of Non-GAAP Financial Measures” below.

Cash and cash equivalents were $42.2 million as of the end of the first quarter of 2024.

Recent Business Highlights

  • Bitcoin Depot continued to strengthen its industry-leading market share with 7,061 kiosk locations and 6,734 BDCheckout locations at the end of 1Q24
  • Announced sales team expansion and ordered approximately 3,200 kiosks year-to-date to meet the growing demand from retailers and to support bold expansion strategy
  • Announced over 2,000 new retail locations signed in 1Q24 spanning across several states to increase Bitcoin Depot’s fleet of deployed kiosks and support ambitious goal of deploying 8,000 Bitcoin ATMs by year-end
  • Strengthened profit share program through signed partnerships with Sopris Capital and an investment fund. Through the profit share program, Bitcoin Depot has already added more than 300 additional BTM kiosk locations in 2024
  • Expanded footprint internationally into Puerto Rico and Australia
  • Signed first major grocery store partnership with Fareway across 66 locations

Conference Call

Bitcoin Depot will hold a conference call at 10:00 a.m., Eastern time (7:00 a.m. Pacific time), today to discuss its financial results for the first quarter ended March 31, 2024.

Call Date: Tuesday, May 14, 2024 
Time: 10:00 a.m. Eastern time (7:00 a.m. Pacific time)
U.S. dial-in: 646-968-2525
International dial-in: 888-596-4144
Conference ID: 1037410

The conference call will broadcast live and be available for replay here following the call.

Please call the conference telephone number approximately 10 minutes before the start time. An operator will register your name and organization. If you have any difficulty connecting with the conference call, please contact Bitcoin Depot’s investor relations team at 1-949-574-3860.

A replay of the call will be available beginning after 2:00 p.m. Eastern time on May 14, 2024 through May 21, 2024.

U.S. replay number: 609-800-9909
International replay number: 800-770-2030
Conference ID: 1037410

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 49 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 7,100 kiosk locations as of April 1, 2024. Learn more at www.bitcoindepot.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release and any oral statements made in connection herewith include “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Exchange Act of 1934, as amended. Forward-looking statements are any statements other than statements of historical fact, and include, but are not limited to, statements regarding the expectations of plans, business strategies, objectives and growth and anticipated financial and operational performance, including our growth strategy and ability to increase deployment of our products and services, our ability to strengthen our financial profile, and worldwide growth in the adoption and use of cryptocurrencies,. These forward-looking statements are based on management’s current beliefs, based on currently available information, as to the outcome and timing of future events. Forward-looking statements are often identified by words such as “anticipate,” “appears,” “approximately,” “believe,” “continue,” “could,” “designed,” “effect,” “estimate,” “evaluate,” “expect,” “forecast,” “goal,” “initiative,” “intend,” “may,” “objective,” “outlook,“ ”plan,“ ”potential,“ ”priorities,“ ”project,“ ”pursue,“ ”seek,“ ”should,“ ”target,“ ”when,“ ”will,“ ”would,” or the negative of any of those words or similar expressions that predict or indicate future events or trends or that are not statements of historical matters, although not all forward-looking statements contain such identifying words. In making these statements, we rely upon assumptions and analysis based on our experience and perception of historical trends, current conditions, and expected future developments, as well as other factors we consider appropriate under the circumstances. We believe these judgments are reasonable, but these statements are not guarantees of any future events or financial results. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by any investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond our control.

These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political and legal conditions; failure to realize the anticipated benefits of the business combination; risks relating to the uncertainty of our projected financial information; future global, regional or local economic and market conditions; the development, effects and enforcement of laws and regulations; our ability to manage future growth; our ability to develop new products and services, bring them to market in a timely manner and make enhancements to our platform; the effects of competition on our future business; our ability to issue equity or equity-linked securities; the outcome of any potential litigation, government and regulatory proceedings, investigations and inquiries; and those factors described or referenced in filings with the Securities and Exchange Commission. If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that we do not presently know or that we currently believe are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect our expectations, plans or forecasts of future events and views as of the date of this press release. We anticipate that subsequent events and developments will cause our assessments to change.

We caution readers not to place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date they are made, and we undertake no obligation to update publicly or otherwise revise any forward-looking statements, whether as a result of new information, future events, or other factors that affect the subject of these statements, except where we are expressly required to do so by law. All written and oral forward-looking statements attributable to us are expressly qualified in their entirety by this cautionary statement.

View full release here.

Contacts:

Investors 
Cody Slach, Alex Kovtun 
Gateway Group, Inc. 
949-574-3860 
BTM@gateway-grp.com

Media 
Zach Kadletz, Brenlyn Motlagh, Ryan Deloney 
Gateway Group, Inc.
949-574-3860 
BTM@gateway-grp.com

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Source: Bitcoin Depot Inc.

Released May 14, 2024

V2X (VVX) – A Leadership Transition

Posted on by cpereira@noblefcm.com


Tuesday, May 14, 2024

For more than 70 years, Vectrus has provided critical mission support for our customers’ toughest operational challenges. As a high-performing organization with exceptional talent, deep domain knowledge, a history of long-term customer relationships, and groundbreaking technical expertise, we deliver innovative, mission-matched solutions for our military and government customers worldwide. Whether it’s base operations support, supply chain and logistics, IT mission support, engineering and digital integration, security, or maintenance, repair and overhaul, our customers count on us for on-target solutions that increase efficiency, reduce costs, improve readiness, and strengthen national security. Vectrus is headquartered in Colorado Springs, Colo., and includes about 8,100 employees spanning 205 locations in 28 countries. In 2021, Vectrus generated sales of $1.8 billion. For more information, visit the company’s website at www.vectrus.com or connect with Vectrus on Facebook, Twitter, and LinkedIn.

Joe Gomes, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

A New CEO. Yesterday, V2X announced Jeremy Wensinger has been appointed President, Chief Executive Officer, and a member of the Company’s Board of Directors, succeeding Chuck Prow effective June 17, 2024. According to the Company, this leadership change is the result of a thorough Board-led succession planning process designed to ensure a smooth transition and continue V2X’s positive business momentum.

Board Statement. V2X’s Board noted, “Following a thorough process to identify our next CEO, the Board is confident that Jeremy is a strong, experienced leader for V2X’s next chapter of growth. He has a proven track record of delivering best-in-class financial and operational performance within the broad defense services and aerospace industry, as well as a strategic approach to managing businesses, building strong stakeholder relationships, and creating value.”


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

Unicycive Therapeutics (UNCY) – 1Q24 Reported With Pivotal OLC Data Coming In 2Q24

Posted on by cpereira@noblefcm.com


Tuesday, May 14, 2024

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Pivotal Trial Data Expected During 2Q24. Unicycive reported an Operating Loss of $9.2 million, with a Net Loss of $21.2 million or $(0.61) per share. Importantly, the pivotal trial for OLC, its phosphate binder in development to treat hyperphosphatemia in kidney dialysis patients, is on schedule to report topline data in 2Q24. We anticipate an FDA filing for approval in 2H24. Cash on March 31, 2024, was $48.9 million.

OLC Data in 2Q24 With NDA Expected Later In 2024. The pivotal trial is an open-label single arm study. Its primary endpoint is tolerability, with secondary endpoints of safety and pharmacokinetics. Statistical analysis is not required. The trial has a target enrollment of 60 patients. Once the study is completed, a new drug application (NDA) is expected shortly afterward. We anticipate standard FDA review time, with approval in mid-2025.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*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.