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Release – Ocugen, Inc. Announces U.S. FDA Clearance of IND Amendment to Initiate OCU400 Phase 3 Clinical Trial — First Gene Therapy to Enter Phase 3 with a Broad Retinitis Pigmentosa Indication

Posted on by cpatches

Research News and Market Data on OCGN

MALVERN, Pa., April 08, 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 U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) amendment to initiate a Phase 3 clinical trial of OCU400, a modifier gene therapy product candidate being developed for retinitis pigmentosa (RP).

“The initiation of the OCU400 Phase 3 clinical trial is a significant milestone for patients with RP and a pivotal event for Ocugen as a company,” said Dr. Shankar Musunuri, Chairman, CEO and Co-Founder of Ocugen. “OCU400 is the first gene therapy program to enter Phase 3 with a broad RP indication. Until now, there has been only one marketed product to treat one of the 100 gene mutations associated with RP. Now there is real hope for all RP patients who haven’t had a treatment option.”

The Phase 3 study 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. 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.

In the Phase 1/2 OCU400 clinical trial, a Multi-Luminance Mobility Testing (MLMT) scale was the primary functional endpoint. For the Phase 3 OCU400 clinical trial, an updated mobility course will be used—Luminance Dependent Navigation Assessment (LDNA)— that includes a wider range of light intensity (0.04-500 Lux) and Lux Levels (0-9) with a uniform correlation between Lux level and Lux intensity.

“A sensitive mobility course, LDNA, was developed by Ocugen in collaboration with FDA for the Phase 3 clinical trial to allow enrollment of patients with early to advanced stages of disease,” said Dr. Arun Upadhyay, Chief Scientific Officer at Ocugen. “We are extremely encouraged that with this Phase 3 study design more than 50% of intent to treat RHO patients would meet the responder criteria, which is demonstrating 2 or greater Lux level of improvement after one year of treatment based on Phase 1/2 study results.”

Currently there are approximately 110,000 patients in the United States with RP and 1.6 million patients globally. Of these patients, more than 10% have the RHO genetic mutation.

“We believe that the gene-agnostic clinical trial design provides an appropriate therapeutic option to include patients who have greater potential of benefiting from treatment,” said Dr. Huma Qamar, Chief Medical Officer at Ocugen. “We are looking forward to working with our selected trial sites and leading retinal surgeons to deliver this novel modifier gene therapy to potentially address unmet medical needs.”

Ocugen previously announced that OCU400 has received orphan drug and RMAT designations from the FDA. With the initiation of the Phase 3 clinical trial, OCU400 remains on track for the 2026 BLA approval target.

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.

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

Janet Yellen Signals Potential Tariffs on Chinese Green Energy Exports

Posted on by slightbourne@noblecapitalmarkets.com

U.S. Treasury Secretary Janet Yellen escalated trade tensions with China over its massive subsidies for green industries like electric vehicles, solar panels and batteries. During her recent four-day visit to Beijing, Yellen bluntly warned that the Biden administration “will not accept” American industries being decimated by a flood of cheap Chinese exports – a repeat of the “China shock” that hollowed out U.S. manufacturing in the early 2000s.

At the heart of the dispute are allegations that China has massively overinvested in renewable energy supply chains, building factory capacity far exceeding domestic demand. This excess output is then exported at artificially low prices due to Beijing’s subsidies, undercutting firms in the U.S., Europe and elsewhere.

“Over a decade ago, massive Chinese government support led to below-cost Chinese steel that flooded the global market and decimated industries across the world and in the United States,” Yellen said. “I’ve made it clear that President Biden and I will not accept that reality again.”

While not threatening immediate tariffs or trade actions, the stark warning shows Washington is seriously considering punitive measures if Beijing does not rein in subsidies and overcapacity. Yellen said U.S. concerns are shared by allies like Europe and Japan fearing a glut of unfairly cheap Chinese green tech imports.

For its part, China is pushing back hard. Officials argue the U.S. is unfairly portraying its renewable energy firms as subsidized, understating their innovation. They claim restricting Chinese electric vehicle imports would violate WTO rules and deprive global markets of key climate solutions.

Escalating tensions over green tech subsidies could disrupt trade flows and supply chains for renewable energy developers, electric automakers, battery manufacturers and more across multiple continents. Some key impacts for investors:

Rising Costs: Potential tariffs on Chinese solar panels, wind turbines, EV batteries and other components could increase costs for green energy projects in the U.S. and allied countries, slowing roll-out.

Shifting Competitive Landscape: Non-Chinese exporters of renewable hardware like solar from countries like South Korea, Vietnam or India may benefit from U.S. trade actions against China, increasing overall competition.

Consumer Prices: Green tech price inflation could be passed through to consumers for products like rooftop solar systems, home batteries and EVs if tariffs increase costs.

Strategic Decoupling: If tensions escalate towards a full “decoupling”, it could accelerate efforts by the U.S., Europe and others to secure their supply chains by bringing more critical green industries in-house through domestic investments and subsidies.

Stock Impacts: Depending on how tensions unfold, stocks of firms exposed to U.S.-China green tech trade flows could face volatility and disruptions in both directions. Tariffs would likely create clear winners and losers.

For now, Yellen says new forums for discussions have been created to potentially resolve overcapacity concerns. However, her blunt warnings suggest the U.S. will not hesitate to take tougher actions to protect America’s fledgling renewable energy and electric vehicle industries from alleged unfair Chinese trade practices.

Discover Emerging Growth Consumer, Communications, Media, and Technology Companies at Noble Capital Markets’ June Virtual Equity Conference

Posted on by cpatches
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View the Conference eBook

  • Emerging Growth Public Consumer, Communications, Media, Technology (and more) Company Executive Presentations
  • Q&A Sessions Moderated by Noble’s Analysts and Bankers
  • Scheduled 1×1 Meetings with Qualified Investors

Noble Capital Markets, a full-service SEC / FINRA registered broker-dealer, dedicated exclusively to serving emerging growth companies, is pleased to present the Consumer, Communications, Media, and Technology Emerging Growth Virtual Equity Conference, taking place June 26th and 27th, 2024. This virtual gathering is set to be an immersive experience, bringing together a unique blend of investors, industry leaders, and experts in the consumer, communications, media, and technology sectors.

Part of Noble’s Robust 2024 Events Calendar

The Consumer, Communications, Media, and Technology Emerging Growth Virtual Equity Conference is part of Noble’s 2024 event programming, featuring a range of c-suite interviews, in-person non-deal roadshows throughout the United States, two other sector-specific virtual equity conferences, and culminating in Noble’s preeminent in-person investor conference, NobleCon20, to be held at Florida Atlantic University in Boca Raton, Florida December 3-4. Keep an eye out for the official press release on NobleCon20 coming soon.

Check out the calendar of upcoming in-person non-deal roadshows here.

Sign up to receive more information on Noble’s other virtual conferences here.

What to Expect

The Consumer, Communications, Media, and Technology Emerging Growth Virtual Equity Conference will feature 2 days of corporate presentations from up to 50 innovative public consumer, communications, media, and technology companies, showcasing their latest advancements and investment opportunities. Each presentation will be followed by a fireside-style Q&A session proctored by one of Noble’s analysts or bankers, with questions taken from the audience during the presentation. Panel presentations are planned, featuring key opinion leaders in these sectors, providing valuable insights on emerging trends. Scheduled one-on-one meetings with public company executives, coordinated by Noble’s dedicated Investor Outreach team, are also available to qualified investors.

Why Your Company Should Present

Looking to increase awareness in your company and increase liquidity? Paid participation in Noble’s investor conferences, both virtual and in-person, provides that opportunity, with a tailored experience aimed at delivering substantial value. After 40 years of serving emerging growth companies, and the investors who follow them, Noble has built an investor base eager to discover where the next success story lies.

Noble’s investor base is relevant and, in many cases, new to your company. Noble’s dedicated Investor Outreach team provides unmatched exposure to investors that can invest in your company, including small money managers, family offices, RIAs, wealth managers, self-directed investors, and institutions. Most of Noble’s investors specifically seek undervalued, overlooked, emerging investment opportunities.

The cost to present includes your corporate presentation with a Q&A session proctored by one of Noble’s analysts or bankers, a webcast recording, scheduled 1×1 meetings with qualified investors, and marketing on Channelchek.

Benefits for Investors

Hear directly from the c-suite of the next innovators in consumer, communications, media, and technology and learn about new investment opportunities. The Q&A portion of each presentation gives you the opportunity to have your questions answered during or after the proctored session. The planned panel presentations are sure to provide expert insight on growing trends in the healthcare space. And, for qualified investors, one-on-one meetings are available with company executives; scheduled by Noble’s dedicated Investor Outreach team. All from the comfort of your own desk, and at no cost.

How to Register

Limited presenting slots are available

Publicly traded companies in these sectors can submit their registration details here.

If you have any questions about presenting, please contact events@noblecapitalmarkets.com

Investor / Guest attendees can register here

Interested in becoming a sponsor of Noble’s virtual and in-person investor conferences?

Contact events@noblecapitalmarkets.com for sponsorship information.

The GEO Group (GEO) – New Debt Priced; Raising PT to $17

Posted on by cpereira@noblefcm.com


Monday, April 08, 2024

The GEO Group, Inc. (NYSE: GEO) is a leading diversified government service provider, specializing in design, financing, development, and support services for secure facilities, processing centers, and community reentry centers in the United States, Australia, South Africa, and the United Kingdom. GEO’s diversified services include enhanced in-custody rehabilitation and post-release support through the award-winning GEO Continuum of Care®, secure transportation, electronic monitoring, community-based programs, and correctional health and mental health care. GEO’s worldwide operations include the ownership and/or delivery of support services for 103 facilities totaling approximately 83,000 beds, including idle facilities and projects under development, with a workforce of up to approximately 18,000 employees.

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.

Upsized and Pricing. The GEO Group announced a private offering of $1.275 billion of senior notes, comprised of $650 million 8.625% notes due 2029 and $650 million 10.25% notes due 2031. GEO had originally sought to raise $1.2 billion. The Company also announced a new $450 million Term Loan B bearing interest at SOFR plus 5.25%. Net proceeds are anticipated to be $1.67 billion.

6.50% Convertible Notes. The Company also announced it is exchanging $177 million principal amount of its 6.50% Exchangeable Senior Notes due 2026, representing about 77% of the outstanding principal amount. GEO will pay cash and common stock for the estimated $305 million market value of the Notes, with the cash portion expected to be $177 million. At the current stock price, the remaining $128 million of principal amount would be exchanged for approximately 9.1 million GEO shares.


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. 

Comstock Inc. (LODE) – Accelerating Commercialization Across Multiple Business Lines

Posted on by cpereira@noblefcm.com


Monday, April 08, 2024

Comstock (NYSE: LODE) innovates technologies that contribute to global decarbonization and circularity by efficiently converting under-utilized natural resources into renewable fuels and electrification products that contribute to balancing global uses and emissions of carbon. The Company intends to achieve exponential growth and extraordinary financial, natural, and social gains by building, owning, and operating a fleet of advanced carbon neutral extraction and refining facilities, by selling an array of complimentary process solutions and related services, and by licensing selected technologies to qualified strategic partners. To learn more, please visit www.comstock.inc.

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.

First quarter 2024 perception report. RB Milestone, Comstock’s investor relations firm, released its first quarter 2024 stakeholder perception report which provides insight into Comstock’s operational milestones and strengths and weaknesses as perceived by stakeholders. The accompanying presentation highlighted the achievement of significant company milestones, notably in its Metals and Fuels segments. An underreported point made during the presentation is that Comstock has approximately $225 million of net operating loss tax carry-forward that may be used to offset gains from sales of non-core assets and future profits.

Growing customer commitments. During the first quarter, Comstock Metals received all permits for its solar panel recycling facility and began commissioning the plant. Comstock Metals has received over 60 tons of end-of-life solar panels for which it has received cash and expects to begin recognizing revenue in the second quarter as the panels are processed. Supplier commitments have exceeded expectations and Comstock is preparing permits for its first industry-scale facility.


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. 

Bitcoin Depot (BTM) – Expansion Ahead of Schedule

Posted on by cpereira@noblefcm.com


Monday, April 08, 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.

International expansion. The company recently announced its plans to ship 125 kiosks to Australia’s largest cities, Sydney, Melbourne and Brisbane, in Q2 2024. Notably, we believe there is a sizeable opportunity for growth in Australia, which has a population of approximately 27 million people, and less than 1000 Bitcoin ATM’s in the entire county. In addition to Australia, the company expanded to Puerto Rico in March, adding 87 kiosks.

Franchise opportunities. In our view, the company should benefit from franchising, which offers the company a capital efficient method to expand operations. Notably, the company captures roughly 30%-50% of profits from franchise locations with virtually no capital committed. We view the relatively new franchise program favorably.


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. 

Release – Maia Biotechnology To Present At Two Investor Conferences In April 2024

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

April 05, 2024 8:01am EDTDownload as PDF

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that Chairman and Chief Executive Officer Vlad Vitoc, M.D. will present at two investor conferences during the month of April: the 14th Annual LD Micro Invitational taking place April 8-9, 2024, in New York City; and the Noble Capital Markets Emerging Growth Virtual Healthcare Equity Conference taking place April 17-18, 2024.

LD Micro:

Presentation:04:30PM ET on April 09, 2024*
Format:In-person and virtual
Location:Sofitel New York, New York City
Conference registration:Visit the conference website
Livestream registration:Visit Sequire Events
1×1 meetings:Upon request by registered investors

Noble Capital Markets:

Presentation:11:00AM ET on April 17, 2024*
Format:Virtual
Conference registration:Visit the conference website
1×1 meetings:Upon request by registered investors

*Please note that the presentation date and time are subject to change. Participants should refer to the final program agendas for up-to-date information.

MAIA’s lead candidate is THIO, a small molecule telomere-targeting anticancer agent that acts by producing direct telomeric DNA damage and inducing cancer-specific immune responses. THIO’s efficacy in non-small cell lung cancer (NSCLC) is being evaluated in THIO-101, a Phase 2 go-to-market clinical trial nearing completion, which is expected to be the first completed clinical study of a telomere-targeting agent in the field of cancer drug discovery and treatment. MAIA plans to pursue the FDA’s accelerated approval program for THIO.

Recent news from MAIA’s THIO-101 trial includes:

About MAIA Biotechnology, Inc.

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240405374193/en/

Investor Relations Contact
+1 (872) 270-3518
ir@maiabiotech.com

Source: MAIA Biotechnology, Inc.

Released April 5, 2024

Release – Ocugen Announces Positive Data And Safety Monitoring Board Review And Initiation Of Enrollment In Medium Dose For OCU410—A Modifier Gene Therapy—In Phase 1/2 Armada Study For Geographic Atrophy

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

April 5, 2024

  • Established Low Dose as Safe and Tolerable Dose in Current OCU410 Clinical Trial
  • DSMB Approval to Proceed with Medium Dose Cohort Dosing

Malvern, Pa., April 05, 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 Data and Safety Monitoring Board (DSMB) for the Phase 1/2 ArMaDa clinical trial for OCU410 recently convened and approved to proceed dosing with the medium dose of OCU410 in the dose-escalation phase of the study.

Three subjects with geographic atrophy (GA) were dosed in the Phase 1/2 clinical trial to date. An additional three subjects will be dosed with the medium dose (Cohort 2) and three patients with the high dose (Cohort 3) of OCU410 in the dose-escalation phase.

“The DSMB has recommended moving forward to medium dose for dosing subjects with GA,” said Dr. Peter Chang, MD, FACS, DSMB Chair for the OCU410 clinical trial. “No serious adverse events (SAEs) related to OCU410 have been reported to date. I believe that this marks a critical next step towards determining the optimal dosing regimen and an important milestone for the clinical development of OCU410.”

“The positive DSMB review for the first modifier gene therapy for GA significantly builds on the favorable safety and tolerability profile exhibited by OCU410,” said Huma Qamar, M.D., MPH, Chief Medical Officer of Ocugen. “We are very enthusiastic about the potential of OCU410 as a one-time treatment for life with a single sub-retinal injection.”

Currently approved products to treat GA have significant limitations, as they require multiple injections per year and only target one pathway contributing to GA. OCU410 regulates multiple pathways involved with the disease including: lipid metabolism, inflammation, oxidative stress, and membrane attack complex (complement).

The ArMaDa clinical trial will assess the safety of unilateral subretinal administration of OCU410 in subjects with GA and will be conducted in two phases. Phase 1 is a multicenter, open-label, dose-ranging study consisting of three dose levels [low dose (2.5×1010 vg/mL), medium dose (5×1010 vg/mL), and high dose (1.5 ×1011 vg/mL)]. Phase 2 is a randomized, outcome accessor-blinded, dose-expansion study in which subjects will be randomized in a 1:1:1 ratio to either one of two OCU410 treatment groups or to an untreated control group.

Ocugen is committed to finding solutions for inherited retinal diseases as well as blindness diseases affecting millions. GA is an advanced form of dry age-related macular degeneration (dAMD) and affects approximately 1 million people in the United States.

About dAMD
dAMD affects approximately 10 million Americans and more than 266 million people worldwide. It is characterized by the thinning of the macula. The macula is the part of the retina responsible for clear vision in one’s direct line of sight. dAMD involves the slow deterioration of the retina with submacular drusen (small white or yellow dots on the retina), atrophy, loss of macular function and central vision impairment. dAMD accounts for 85-90% of the total AMD population.

About OCU410
OCU410 utilizes an AAV delivery platform for the retinal delivery of the RORA (ROR Related Orphan Receptor A) gene. The RORA protein plays an important role in lipid metabolism, reducing lipofuscin deposits and oxidative stress, and demonstrates an anti-inflammatory role as well as inhibiting the complement system in in-vitro and in-vivo (animal model) studies. These results demonstrate the ability for OCU410 to target multiple pathways linked with dAMD pathophysiology. Ocugen is developing AAV-RORA as a one-time gene therapy for the treatment of GA.

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, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

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

Blowout U.S. Jobs Report Keeps Fed on Hawkish Path, For Now

Posted on by slightbourne@noblecapitalmarkets.com

The red-hot U.S. labor market showed no signs of cooling in March, with employers adding a whopping 303,000 new jobs last month while the unemployment rate fell to 3.8%. The much stronger-than-expected employment gains provide further evidence of the economy’s resilience even in the face of the Federal Reserve’s aggressive interest rate hikes over the past year.

The blockbuster jobs number reported by the Bureau of Labor Statistics on Friday handily exceeded economists’ consensus estimate of 214,000. It marked a sizeable acceleration from February’s solid 207,000 job additions and landed squarely above the 203,000 average over the past year.

Details within the report were equally impressive. The labor force participation rate ticked up to 62.7% as more Americans entered the workforce, while average hourly earnings rose a healthy 0.3% over the previous month. On an annualized basis, wage growth cooled slightly to 4.1% but remains elevated compared to pre-pandemic norms.

Investors closely watch employment costs for signs that stubbornly high inflation may be becoming entrenched. If wage pressures remain too hot, it could force the Fed to keep interest rates restrictive for longer as inflation proves difficult to tame.

“The March employment report definitively shows inflation remains a threat, and the Fed’s work is not done yet,” said EconomicGrizzly chief economist Jeremy Hill. “Cooler wage gains are a step in the right direction, but the central bank remains well behind the curve when it comes to getting inflation under control.”

From a markets perspective, the report prompted traders to dial back expectations for an imminent Fed rate cut. Prior to the data, traders were pricing in around a 60% chance of the first rate reduction coming as soon as June. However, those odds fell to 55% following the jobs numbers, signaling many now see cuts being pushed back to late 2024.

Fed chair Jerome Powell sounded relatively hawkish in comments earlier this week, referring to the labor market as “strong but rebalancing” and indicating more progress is needed on inflation before contemplating rate cuts. While the central bank welcomes a gradual softening of labor conditions, an outright collapse is viewed as unnecessarily painful for the economy.

If job gains stay heated but wage growth continues moderating, the Fed may feel emboldened to start cutting rates in the second half of 2024. A resilient labor market accompanied by cooler inflation pressures is the so-called “soft landing” scenario policymakers are aiming for as they attempt to tame inflation without tipping the economy into recession.

Sector details showed broad-based strength in March’s employment figures. Healthcare led the way by adding 72,000 positions, followed by 71,000 new government jobs. The construction industry saw an encouraging 39,000 hires, double its average monthly pace over the past year. Leisure & hospitality and retail also posted healthy employment increases.

The labor market’s persistent strength comes even as overall economic growth appears to be downshifting. GDP rose just 0.9% on an annualized basis in the final quarter of 2023 after expanding 2.6% in Q3, indicating deceleration amid the Fed’s rate hiking campaign.

While consumers have remained largely resilient thanks to a robust labor market, business investment has taken a hit from higher borrowing costs. This divergence could ultimately lead to payroll reductions in corporate America should profits come under further pressure.

For now, however, the U.S. labor force is flexing its muscles even as economic storm clouds gather. How long employment can defy the Fed’s rate hikes remains to be seen, but March’s outsized jobs report should keep policymakers on a hawkish path over the next few months.

Release – The GEO Group Enters Into Private Exchange Agreements With Certain 6.50% Convertible Senior Noteholders

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GEO

April 5, 2024

PDF Version

BOCA RATON, Fla.–(BUSINESS WIRE)–Apr. 5, 2024– The GEO Group (NYSE: GEO) (“GEO” or the “Company”), announced that it has entered into private exchange agreements with certain holders (the “Noteholders”) of GEO Corrections Holdings, Inc.’s 6.50% Exchangeable Senior Notes due 2026 (the “6.50% Exchangeable Senior Notes”).

The Noteholders have agreed to exchange $177 million in aggregate principal amount of the outstanding 6.50% Exchangeable Senior Notes for a current estimated valuation of $305 million. The consideration will consist of cash and shares of GEO’s common stock issued at closing. The final exchange value and number of shares of common stock to be issued by GEO to the Noteholders will be determined based upon a volume-weighted average price per share of common stock during an averaging period commencing today and lasting 20 trading days.

GEO expects to fund the cash portion for the exchanges, which totals $177 million, with the net proceeds from its previously announced offering of senior secured notes due 2029 and senior unsecured notes due 2031 or, if necessary, cash on hand.

The 6.50% Exchangeable Senior Notes to be exchanged represent approximately 77% of the outstanding principal amount, with $53 million in aggregate principal amount remaining outstanding following the exchange.

This press release does not constitute an offer to sell or a solicitation to buy any of the securities described herein, nor shall there be any offer, solicitation, or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.

About The GEO Group

The GEO Group, Inc. (NYSE: GEO) is a leading diversified government service provider, specializing in design, financing, development, and support services for secure facilities, processing centers, and community reentry centers in the United States, Australia, South Africa, and the United Kingdom. GEO’s diversified services include enhanced in-custody rehabilitation and post-release support through the award-winning GEO Continuum of Care®, secure transportation, electronic monitoring, community-based programs, and correctional health and mental health care. GEO’s worldwide operations include the ownership and/or delivery of support services for 100 facilities totaling approximately 81,000 beds, including idle facilities and projects under development, with a workforce of up to approximately 18,000 employees.

Use of forward-looking statements

This press release includes forward-looking statements regarding the closing of the private exchange transactions and expected reduction in the total outstanding 6.50% Exchangeable Senior Notes. These forward-looking statements may be affected by risks and uncertainties in GEO’s business and market conditions. This information is qualified in its entirety by cautionary statements and risk factor disclosure contained in GEO’s Securities and Exchange Commission filings, including GEO’s report on Form 10-K for the year ended December 31, 2023, and GEO’s reports on Form 10-Q and Form 8-K filed with the Commission. GEO wishes to caution readers that certain important factors may have affected and could in the future affect GEO’s actual results and could cause GEO’s actual results for subsequent periods to differ materially from those expressed in any forward-looking statement made by or on behalf of GEO, including the risks that the private exchanges cannot successfully be completed. GEO undertakes no obligation to update forward-looking statements to reflect events or circumstances after the date hereof, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240404523690/en/

Pablo E. Paez, (866) 301 4436
Executive Vice President, Corporate Relations

Source: The GEO Group, Inc.

Johnson & Johnson Flexes Its M&A Muscle with $12.5 Billion Shockwave Medical Buy

Posted on by slightbourne@noblecapitalmarkets.com

Healthcare giant Johnson & Johnson announced on Friday that it is acquiring Shockwave Medical for a whopping $12.5 billion in cash, in a move that further bolsters its cardiovascular device portfolio. The deal allows J&J to add Shockwave’s innovative intravascular lithotripsy (IVL) system to its offerings.

IVL is a minimally invasive technique that uses sonic pressure waves to crack calcified plaque in arteries prior to inserting stents – similar in concept to how shockwaves are used to break up kidney stones. This novel approach helps improve outcomes for certain challenging arterial calcification cases that traditional treatment can struggle with.

Under the terms of the agreement, J&J will pay $335 per share for Shockwave, representing a 17% premium over the company’s stock price in late March when acquisition rumors first surfaced. The total enterprise value of the transaction is approximately $13.1 billion when including the cash on Shockwave’s balance sheet.

The acquisition comes hot on the heels of J&J’s $16.6 billion purchase of heart pump maker Abiomed last year, as the company doubles down on expanding its cardiovascular capabilities. Analysts see significant opportunity in this space, with RBC estimating the total addressable market for IVL and similar calcified plaque treatments at around $10 billion annually.

For Shockwave, being acquired by the deep-pocketed J&J provides the resources to ramp up commercialization of its breakthrough IVL system, which generated $730 million in sales last year. Meanwhile, the deal aligns with J&J’s strategic efforts to augment its medical device segment amid increasing competitive pressures in its pharmaceutical arm.

The Shockwave acquisition exemplifies a broader trend of large healthcare conglomerates snapping up promising smaller companies and technologies to drive future growth. With organic drug pipelines drying up and patent expirations looming, “big pharma” players are turning to M&A to inject innovation into their product portfolios.

Just last week, pharma giant AbbieVie announced multi-million dollar buyouts of smaller biotech firm Landos. Earlier this year, AstraZeneca shelled out $2.4 billion for oncology innovator Fusion Pharmaceuticals.

For investors interested in identifying the next potential M&A targets in healthcare’s hot growth areas, one upcoming event to mark on the calendar is the Noble Capital Markets Emerging Growth Virtual Healthcare Conference on April 17-18. This two-day virtual investor conference will feature presentations from emerging public and private healthcare companies spanning biotech, medical devices, healthcare IT and services. You can register at no cost for this event here.

The Noble virtual conference provides an ideal opportunity for institutional investors, financial advisors and independent investors alike to gain insights into cutting-edge healthcare innovations that could be tomorrow’s M&A prizes for industry titans like J&J. Presenting companies will span an array of therapeutic areas including oncology, neurology, xenotransplantation and more.

As the Shockwave deal demonstrates, big pharma isn’t shying away from spending big to stay ahead of the healthcare innovation curve. For investors, uncovering the next game-changing therapies and technologies could uncover lucrative future buyout candidates.

Release – The GEO Group Prices Senior Notes Offering and New Term Loan

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GEO

April 4, 2024

PDF Version

BOCA RATON, Fla.–(BUSINESS WIRE)–Apr. 4, 2024– The GEO Group (NYSE: GEO) (“GEO” or the “Company”) announced today that it has priced a private offering of $1.275 billion aggregate principal amount of senior notes, comprised of $650.0 million aggregate principal amount of 8.625% senior secured notes due 2029 (the “Secured Notes”) and $625.0 million aggregate principal amount of 10.25% senior unsecured notes due 2031 (the “Unsecured Notes” and together with the Secured Notes, the “Notes”), exempt from registration requirements of the Securities Act of 1933, as amended (the “Securities Act”). The Notes will be guaranteed by GEO’s domestic subsidiaries that are guarantors under a new senior secured credit facility and outstanding senior notes. The offering of the Notes is expected to close on April 18, 2024, subject to customary closing conditions. GEO also announced today that it has priced a new $450.0 million Term Loan B (the “Term Loan”), bearing interest at SOFR plus 5.25%, under a new senior secured credit facility, which is expected to close on April 18, 2024. The offering of the Notes and the new Term Loan are expected to result in net proceeds of approximately $1.67 billion, after deducting the initial purchasers’ discount and estimated expenses payable by GEO.

The net proceeds of the offering of the Notes, borrowings under the new Term Loan, and cash on hand will be used to refinance approximately $1.5 billion of existing indebtedness, including to fund the refinance, repurchase, redemption or other discharge of the Company’s existing Tranche 1 Term Loan and Tranche 2 Term Loan under its existing senior credit facility, the 9.50% senior second lien secured notes, the 10.50% senior second lien secured notes, and the 6.00% senior notes due 2026, to pay related premiums, transaction fees and expenses. GEO also intends to retire or settle a portion of the 6.50% exchangeable senior notes due 2026 issued by GEO Corrections Holdings, Inc., using shares of GEO common stock and cash. GEO expects to fund the cash portion for the retirement or settlement, which is expected to total up to $180.0 million, with a portion of the net proceeds from the offering of the Notes or, if necessary, cash on hand. Nothing in this press release should be construed as an offer to purchase, notice of redemption or a solicitation of an offer to purchase any of the existing term loans or notes, and the closing of the offering of the Notes is not conditioned on the consummation of such repurchase, redemption or other discharge; however, the repurchase, redemption or other discharge of the existing term loans and notes are conditioned on the consummation of the offering of Notes and the closing of the new Term Loan and certain other financing transactions.

The Notes were offered and will be sold in the United States only to persons reasonably believed to be “qualified institutional buyers” pursuant to Rule 144A under the Securities Act, and outside the United States only to non-U.S. persons pursuant to Regulation S under the Securities Act. The Notes have not been, and will not be, registered under the Securities Act or any state securities laws and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements under the Securities Act and applicable state laws. This news release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the Notes in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

About The GEO Group

The GEO Group, Inc. (NYSE: GEO) is a leading diversified government service provider, specializing in design, financing, development, and support services for secure facilities, processing centers, and community reentry centers in the United States, Australia, South Africa, and the United Kingdom. GEO’s diversified services include enhanced in-custody rehabilitation and post-release support through the award-winning GEO Continuum of Care®, secure transportation, electronic monitoring, community-based programs, and correctional health and mental health care. GEO’s worldwide operations include the ownership and/or delivery of support services for 100 facilities totaling approximately 81,000 beds, including idle facilities and projects under development, with a workforce of up to approximately 18,000 employees.

Use of forward-looking statements

This press release includes forward-looking statements regarding GEO’s intention to issue the Notes, borrow the term loan and its intended use of the net proceeds. These forward-looking statements may be affected by risks and uncertainties in GEO’s business and market conditions. This information is qualified in its entirety by cautionary statements and risk factor disclosure contained in GEO’s Securities and Exchange Commission filings, including GEO’s report on Form 10-K for the year ended December 31, 2023, and GEO’s reports on Form 10-Q and Form 8-K filed with the Commission. GEO wishes to caution readers that certain important factors may have affected and could in the future affect GEO’s actual results and could cause GEO’s actual results for subsequent periods to differ materially from those expressed in any forward-looking statement made by or on behalf of GEO, including the risks that the offering of the Notes and/or the closing of the new Term Loan cannot be successfully completed, that the refinance, repurchase, redemption or other discharge of its Tranche 1 Term Loan and Tranche 2 Term Loan under its existing senior credit facility, the 9.50% senior second lien secured notes, the 10.50% senior second lien secured notes, and the 6.00% senior notes due 2026 cannot be successfully completed, and that the retirement or settlement of a portion of the 6.50% exchangeable senior notes due 2026 issued by GEO Corrections Holdings, Inc. cannot be successfully completed. GEO undertakes no obligation to update forward-looking statements to reflect events or circumstances after the date hereof, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240404983014/en/

Pablo E. Paez (866) 301 4436
Executive Vice President, Corporate Relations

Source: The GEO Group, Inc.

Release – Bitcoin Depot Announces Expansion into Australia with 125 Bitcoin ATMs

Posted on by aweinsoff@channelchek.com

Research News and Market Data on BTM

April 04, 2024 8:00 AM EDT

Bitcoin Depot plans to install BTMs in Retail Locations Across Sydney, Melbourne, and Brisbane

ATLANTA, April 04, 2024 (GLOBE NEWSWIRE) — Bitcoin Depot (NASDAQ: BTM), a U.S.-based Bitcoin ATM (“BTM”) operator and leading fintech company, today announced that it plans to expand its footprint internationally into Australia and ship 125 kiosks to the country in Q2 2024. The Company eagerly anticipates further expanding its global presence by offering its cash-to-Bitcoin services to individuals across the biggest metropolitan cities in the country, such as Sydney, Melbourne, and Brisbane. This announcement follows closely on the heels of the Company’s expansion into Puerto Rico in March.

“This strategic expansion into Australia marks a significant step for us, bringing our Bitcoin ATMs to more of an untapped market with significant growth potential and lower competition,” said Brandon Mintz, CEO of Bitcoin Depot. “Our goal is to offer a simple, quick, and convenient process for converting cash into Bitcoin. We see immense opportunity for growth in Australia and are excited to work with new retail partners, serve a broader customer base, and introduce Bitcoin to new users across the country. With this announcement, Bitcoin Depot will be operating in at least three countries in 2024, and we believe there is potential for further international expansion.”

Bitcoin Depot sees immense potential for Australia due to the country’s roughly 27 million-person population and its current BTM kiosk count of roughly 950 BTMs amongst only 10 operators, according to data from Coin ATM Radar. This presents a unique opportunity for the Company to capitalize on this gap in the market and the growing demand for accessible Bitcoin services in the country.

Bitcoin Depot’s products and services provide an intuitive, quick, and convenient process for converting cash into Bitcoin. This allows users to access the broader digital financial system, including using Bitcoin to make payments, transfers, remittances, online purchases, and investments.

“When I founded Bitcoin Depot seven years ago, my vision was to make cryptocurrency accessible to all. Today, I’m thrilled to see the significant strides we’ve made, particularly with our geographic expansion into Australia. This move not only enhances accessibility but also underscores our commitment to providing exceptional convenience and service in as many retail locations as possible,” said Mintz.

This news adds to the Company’s momentum, following recent expansion announcements and surpassing its goal of deploying 8,000 Bitcoin ATMs. Bitcoin Depot now boasts the largest installed fleet of BTMs in its history, solidifying its position as the leading BTM operator in North America. Despite market turbulence, the Company went public on a major U.S. stock exchange in 2023, earning recognition in Forbes 30 Under 30 and Deloitte’s 2023 Technology Fast 500.

About Bitcoin Depot 
Bitcoin Depot Inc. (Nasdaq: BTM) was founded in 2016 with the mission to connect those who prefer to use cash to the broader, digital financial system. Bitcoin Depot provides its users with simple, efficient and intuitive means of converting cash into Bitcoin, which users can deploy in the payments, spending and investing space. Users can convert cash to bitcoin at Bitcoin Depot kiosks in 48 states and at thousands of name-brand retail locations in 29 states through its BDCheckout product. The Company has the largest market share in North America with approximately 7,400 kiosk locations as of April 1, 2024. Learn more at www.bitcoindepot.com.   

Cautionary Note 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. 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, the anticipated effects of the Amendment, and the closing of the Preferred Sale. 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; 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.

Contacts: 

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

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

Source: Bitcoin Depot Inc.

Released April 4, 2024