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SenesTech Inc. (NASDAQ: SNES) Releases Q1 2024 Financial Results Reflecting ‘Outstanding Growth’

  • SenesTech reported record Q1 2024 revenue of $415,000, an increase of 78% compared to Q1 2023 and a 41% sequential increase from Q4 2023
  • The company attributes this growth to the introduction in January 2024 of Evolve(TM), its soft-bait product featuring breakthrough, next-generation technology that targets rat populations by using non-lethal methods to restrict fertility
  • SenesTech is anticipating additional growth following the completion of an efficacy study providing data requested by certain state and international regulators, as this could open new markets that were previously inaccessible
  • In May, the company also launched Evolve(TM) Mouse, a soft-bait product to control mouse infestations; SenesTech expects Evolve(TM) Mouse, which doubles its addressable market opportunity, to be a key driver of growth throughout the rest of the year

SenesTech (NASDAQ: SNES), the provider of a one-of-a-kind technology for controlling animal pest populations through fertility control and the only manufacturer of commercially available, EPA-registered Rat Birth Control(R), recently announced financial results for the first quarter of 2024, ended March 31, 2024, and released operational highlights (https://ibn.fm/kxzyA). During this reporting period, the company reported record revenue of $415,000, a year-over-year increase of 78% compared to the first quarter of 2023. This was also a 41% increase sequentially from the fourth quarter of 2023.

“The key driver [for this growth] has been the introduction of Evolve(TM), our all-new soft-bait product launched in January of this year, which has quickly become the company’s biggest selling product, contributing more than 50% of the first quarter revenue,” said SenesTech President and CEO Joel Fruendt during a conference call accompanying the release of the results.

But Fruendt noted that this “outstanding growth reflected regulatory approval of Evolve in only 30 states,” pointing to the potential for even more growth in the future. “There were several states, including high potential states such as Florida, that required an efficacy study before approval. That efficacy study is now complete, which bodes well for acceptance by the remaining states and further accelerated growth in Q2,” explained Fruendt.

Completed at an independent research facility in April, the efficacy study yielded positive results, which confirmed a significant reduction in litter size through only one breeding cycle. Describing these results, Fruendt said, “This indicates a 50% reduction in population over six months, compared to leaving the population untreated and 90% plus after one year integrated into an IPM program. We will now start some longer-term field trials at customer locations, and we fully expect the efficacy to increase significantly over multiple litters with increased consumption and real-world conditions.”

The company expects Evolve to be the product of choice for rodent population control, especially now that the efficacy study has provided the data requested by certain state and international regulators. And with the New York City Council introducing a proposal for the deployment of “EPA-approved rat birth control” to address rat infestations, SenesTech appears well poised as the only manufacturer of such product, given the city’s high visibility.

Evolve is the first and only soft bait product featuring breakthrough, next-generation technology that targets rat populations by using non-lethal methods to restrict fertility. The product focuses on the rapid reproduction of rats by reducing or eliminating the fertility of rats, thus addressing the fundamental driver of rodent overpopulation. In addition, it has a shelf life of one year, making it an excellent rodent control product for distribution, and is available at a competitive price compared to traditional rodenticides, according to Fruendt.

“Evolve has proven to be a very versatile product that is perfect for many distribution channels that focus on our target market. To keep focus on each of these areas, we have developed our six-channel strategy for distribution. Our six channels are e-commerce, international, agri-business, pest management, industrial, and retail,” explained Fruendt.

Accordingly, SenesTech has secured distribution, stocking agreements, and initial purchase orders with several grain management and open-field agricultural distributors, and expanded agreements with leading distributors in the pest management industry, including DIY Pest Control and Veseris. SenesTech has also extended its geographic reach, with opportunities in Australia, Hong Kong, Macau, New Zealand, Singapore, The Netherlands, and the United Arab Emirates (“UAE”).

Moreover, SenesTech is launching a dedicated Amazon store in May to expand distribution to the do-it-yourself market. The company has also expanded its sales and marketing efforts through agreements with manufacturers’ rep groups to bring its products to retailers and industrial suppliers, who will, in turn, potentially provide access to the facilities management and food safety markets.

Another key highlight for the company was the launch of Evolve Mouse, a soft-bait product that utilizes the same revolutionary breakthrough fertility solution as Evolve to control mouse infestations. Product shipments began in May 2024, with DIY Pest Control committing to a sizable pre-order. The company expects Evolve Mouse to be a key driver of growth throughout the rest of the year.

“[Evolve Mouse] effectively doubles our addressable market opportunity. It has been estimated that U.S. rodent pest management product sales, over half of which target mouse infestations, are more than $1 billion annually and growing,” explained Fruendt. He separately noted in the press release announcing the Q1 2024 results that Evolve Mouse, SenesTech’s first population control solution outside of rats, highlights the first step in the company’s long-term product evolution roadmap to bring fertility control solutions to a wide variety of animal pests.

“We are extremely pleased with the progress the team has made in 2024 and look forward to the positive impact the many recent initiatives we have implemented will produce,” concluded Fruendt in the press release.

To listen to the recorded webcast of the conference call, visit https://nnw.fm/LRBbT https://ibn.fm/ho7Vv (registration required).

For more information, visit the company’s website at www.SenesTech.com.

NOTE TO INVESTORS: The latest news and updates relating to SNES are available in the company’s newsroom at https://ibn.fm/SNES

HealthLynked Corp. (HLYK) Can Add Tens-of-thousands of Members by Improving Care for Students vis-à-vis its Affinity Marketing Efforts to U.S. Universities

  • The HealthLynked platform provides secure and quick access for patient/doctor records communication, supporting all types of health related utilization, including telemedicine and remote student applications
  • University health clinics often face challenges when transferring medical records – and this limits coordinated care for students
  • The HealthLynked platform provides a streamlined approach to medical records access, allowing students to securely share their health information with relevant parties

HealthLynked (OTCQB: HLYK) is a company on a mission to build a superior healthcare system through the efficient integration of patient histories, genetic data, and demographic insights, into a sophisticated AI-driven platform that streamlines patient care and also analyzes trends across large populations to proactively manage health outcomes.

One aspect of this mission is to solve a problem that often plagues the almost 20 million students enrolled in universities and colleges.  Universities often face challenges when transferring medical records – and this limits coordinated care for student patients across the board. HealthLynked’s solution centralizes records and makes them accessible across multiple care settings.

Transferring medical records has always been a tedious task, especially for students with complex health needs. Concerned parents often find themselves navigating through complex and confusing HIPAA regulations to access vital information about their child’s health. Ensuring the smooth transition of medical records upon graduation without overburdening clinic staff has remained a pressing issue, one that HealthLynked solves.

HealthLynked is a game-changer when it comes to student healthcare. The platform provides a streamlined approach to medical records access, allowing students to securely share their health information with relevant parties. This ensures proper coordination between university clinics and home-based specialists, significantly reducing the risk of errors or medication interactions, particularly for students managing multiple prescriptions.

The platform’s innovative co-management feature offers parents peace of mind by granting them access to their child’s health information with consent. This not only fosters better communication with university clinics but also ensures compliance with stringent HIPAA regulations, addressing a longstanding concern among parents.

For students with complex health needs requiring specialized care or mental health services, HealthLynked facilitates seamless sharing of medical history between university and home-based providers. This coordinated approach ensures continuity of treatment and enhances overall care management, irrespective of the student’s location.

In addition to facilitating traditional healthcare services, HealthLynked also empowers students with telemedicine access and mental health services. This feature enables students to consult with their home providers remotely or access mental health support when on-campus options are limited, thereby promoting consistent care and supporting overall well-being.

The benefits of HealthLynked extend beyond individual students to the universities themselves. By embracing this innovative solution, universities can offer students a personalized healthcare experience, earning recognition for prioritizing continuity and convenience in healthcare management. HealthLynked expands its member base and network, catering to thousands of new student users and securing its position as a leading healthcare integration platform.

In addition to student healthcare, the platform bridges the gap between telehealth and telemedicine, offering comprehensive clinical care based on patients’ medical histories. It expands mental health services and addresses gaps in women’s health, empowering patients with tailored care. HealthLynked facilitates at-home testing and routine screenings, enhancing early detection and preventative care.

Through remote monitoring and mobile health integration, patients can manage their health conveniently. The platform enables store-and-forward transmission of patient data and real-time remote consultations, ensuring flexibility and privacy in healthcare delivery. HealthLynked’s advanced network capabilities drive the expansion of telehealth services, providing a holistic and integrated healthcare experience for both patients and providers.

HealthLynked is a comprehensive solution that simplifies healthcare management for students, facilitates family involvement, and ensures continuity of care through telemedicine and coordinated specialist management. By leveraging HealthLynked, patients and healthcare professionals can expand well-being and streamline healthcare delivery across the nation, ushering in a new era of healthcare excellence.

For more information, visit the company’s website at www.HealthLynked.com.

NOTE TO INVESTORS: The latest news and updates relating to HLYK are available in the company’s newsroom at https://ibn.fm/HLYK

DGE 4th PRC Performance Optimization Summit To Unite The Best Minds In The Business

Life science professionals responsible for promotional review, marketing, labelling, communications, and compliance are invited to attend DGE’s 4th PRC Performance Optimization Summit being held in Philadelphia June 5-6, 2024. The most detailed industry event available on this subject, participants will focus in-depth on ways to ensure the best regulatory outcomes. DGE (Dynamic Global Events), a life science leader in organizing B2B events, strives to meet the dynamic informational and networking needs of the pharmaceutical, biotechnology, healthcare, medical devices, and allied industries. DGE events specialize in offering a robust platform where professionals can network, connect, and explore business opportunities in a dynamic environment.

It is difficult to gather PRC input and maintain compliance when turnovers are high, when new technologies like AI come into play, and when team members meet virtually and regulatory decisions seem inconsistent. Industry experts will share breakthrough strategies on all these challenges, and more!

Topics of discussion:

  • Raising company awareness of the PRC brand
  • Maintaining CFL compliance
  • Planning modular content updates
  • Including AI-driven tasks into promotional review
  • Training all team members to be high performers
  • Incorporating strategies for new technologies like VR, mobile websites, and apps
  • Integrating and managing a claims matrix

Attendees can learn and network with industry leaders and gain exclusive access to the event presentation information and contacts. The DGE summit provides all the strategies and tools that PRCs require to maintain compliance for the best regulatory results.

To learn more, please visit https://ibn.fm/98ZsO.

SuperCom Ltd. (NASDAQ: SPCB) Reports Record Profit, 400% YoY EBITDA Growth in Q1 2024

  • SuperCom Ltd. is dedicated to serving government security needs for electronic tracking and monitoring of offenders
  • The company recently reported its quarterly financial results, noting significant growth in revenues, profits, EBITDA, and operating income
  • While SuperCom has focused on acquiring clients in California and other U.S. states, the company also has an international presence, European clients comprising significant part of its business

SuperCom (NASDAQ: SPCB) is widening its competitive edge in the electronic monitoring sector, resulting in revenue growth and a record profit for the company, reflected in the company’s recently released Q1 financial report (https://ibn.fm/rHLua).

“The substantial growth in our gross profit reflects the inherent quality and high-margin potential of our key projects and our successful progression through different stages of these projects,” SuperCom President and CEO Ordan Trabelsi stated in a news release announcing the company’s first quarter financial results.

“Typically, the initial stages of these projects involve higher expenses, which subsequently give way to higher gross margins as the projects advance, as demonstrated by this quarter’s results,” Ordan added. “Additionally, our EBITDA year-over-year has seen a remarkable 400% increase. This improvement is a testament to our rigorous management practices and dedication to effectively leveraging our core business infrastructure.”

SuperCom’s PureSecurity Suite of products provide an end-to-end electronic monitoring solution with state-of-the-art GPS tracking in real time, secured communication, and other monitoring technologies.

The company has applied its tracking and monitoring solutions to various needs. Still, its recent orientation has largely been on providing tracking for domestic violence (“DV”) offenders, helping court-administered house arrest monitoring.

The quarterly financial report notes that revenues increased by 8 percent to $6.9 million, gross profit increased 139 percent to $3.8 million, operating income entered positive territory with a $1.8 million increase, and EBITDA increased by 400% to $2 million.

The technological advances that define SuperCom’s PureSecurity Suite include its support network for programs that include smartphone integration, secure communication, advanced security, anti-tamper mechanisms, fingerprint biometrics, voice communication, unique touch screens, and extended battery life.

For more information, visit the company’s website at www.SuperCom.com.

NOTE TO INVESTORS: The latest news and updates relating to SPCB are available in the company’s newsroom at http://ibn.fm/SPCB

Mountain Top Properties Inc. (MTPP) Poised to Capitalize on Booming Tri-State Real Estate Market

  • Hamptons and Tri-State real estate prices keep rising due to high demand and declining property inventory
  • MTPP positioned to capitalize on current market conditions via strategy that fuses traditional real estate and PropTech investments
  • MTPP recently initiated a Regulation D offering to raise up to $7.5 million for expansion of development projects in the Hamptons and PropTech investments

The Hamptons and broader Tri-State real estate markets continue their unprecedented upward trajectory, driven by the growing demand for properties amid a declining inventory. Mountain Top Properties (OTC: MTPP), a diversified real estate holding company, is strongly positioned to leverage current conditions by fusing traditional real estate development activities and innovative PropTech investments.

MTTP CEO Beau Kelley leads the company’s strategic direction and oversees its operations, leveraging his extensive experience in real estate acquisition and management across the Tri-State area and beyond. Through a partnership with his father Joseph Kelley – manager of On-Site Builder Construction – MTPP is favorably poised to identify emerging trends, secure opportunities, and deliver exceptional value to clients and investors.

Under the management of Joseph Kelley, On Site Builder Construction remains at the forefront of craftsmanship and excellence in the coveted Hamptons market. With over four decades of experience, Mr. Kelley has earned widespread acclaim for his meticulous attention to detail and unwavering commitment to delivering architecturally stunning custom homes – often featured in mainstream print and television media.

MTPP additionally incorporates PropTech investments as a cornerstone of its strategy, reflecting its commitment to innovation in the real estate industry.

PropTech, short for property technology, encompasses a wide range of digital innovations and solutions aimed at enhancing various aspects of real estate operations, from property management to construction to leasing. These investments may include technologies such as AI-driven analytics, virtual reality tours, smart home automation systems, and blockchain-powered property transactions. By harnessing the power of PropTech, MTPP aims to stay at the forefront of industry trends to unlock new opportunities for growth and innovation in the ever-evolving real estate landscape.

MTPP recently initiated a Regulation D offering to raise up to $7.5 million in capital to advance its strategic vision. This offering allows investors to participate in MTPP’s growth trajectory and capitalize on the lucrative opportunities in the Tri-State and prestigious Hamptons regions.

“Mountain Top Properties Inc. is pleased to announce it has filed a 506 Regulation D offering to add up to $7.5 million for the company’s real estate development plans,” said MTPP management in recent statements.

“The funds will be used to expand the company’s partnerships with On Site Builder Construction Co. Inc for the development of projects in the exclusive beachfront community known as the Hamptons; acquire additional projects; expand the marketing effort for the master lease of the 250,000 square foot facility in Pennsylvania; to acquire cutting edge property management operations; and to identify additional partners in the real estate and property technology space. The company expects to add proprietary technologies and best-in-class expertise to its growing list of assets.”

Mountain Top Properties is headquartered in Liverpool, New York with a satellite office in Sag Harbor, New York. Specializing in traditional real estate development and property management throughout the Tri-State area, the company enhances its core operations with strategic PropTech investments to provide investors with a diversified portfolio and consistent returns.

For more information, visit the company’s website at www.Mountain-Top-Properties.com.

NOTE TO INVESTORS: The latest news and updates relating to MTPP are available in the company’s newsroom at https://ibn.fm/MTPP

Torr Metals Inc. (TSX.V: TMET): Shaping the Future of Precious Metals with Gold and Copper

  • Central banks bought 290 metric tons of gold during Q1 2024, while copper prices continue to climb as part of the green energy transition
  • Torr Metals has three highly prospective Canadian gold and copper projects including Kolos, a major intrusive complex considered the last remaining to be tested in the southern Quesnel Trough with similarities to the Copper Mountain porphyry deposit; and Filion, an underexplored gold-bearing greenstone belt adjacent to the Trans-Canada Highway in northern Ontario 
  • TMET insiders are holding tight, controlling about 40% of the company’s outstanding shares as the stock enters a new uptrend

The global market is experiencing a surge in demand for two key commodities: gold and copper. This trend presents a significant opportunity for Torr Metals (TSX.V: TMET), a mineral exploration company focused on developing its highly prospective district-scale gold and copper projects; where significant potential exists for major new discoveries located in highway-accessible, prolific mining jurisdictions of British Columbia and Ontario, Canada.

Gold: A Haven in Times of Uncertainty

Geopolitical tensions and lingering inflation are driving investors towards safe-haven assets like gold.  Prices are near all-time highs, and central banks are increasingly adding gold to their reserves, highlighting its enduring appeal during market volatility.

In 2023, gold demand from central banks equaled 1,037.4 metric tons, narrowly below the record 1,081.9 metric tons set in 2022, according to data from the World Gold Council. There wasn’t a letdown in the first quarter of 2024, with 290 metric tons bought by central banks.

Copper: Fueling the Green Energy Transition

Copper, widely recognized as a barometer of economic trends, is experiencing a price increase due to strong global economic activity and surging demand from green energy technologies like electric vehicles and renewable energy.

Copper is a key component in everything from wind turbines and solar panels to EVs and EV charging stations, making it a vital part of the clean energy infrastructure. With supply struggling to keep pace with this exploding demand, copper prices are expected to climb even higher.

According to research commissioned by the Intentional Copper Association, copper demand is forecast to grow 1.85% annually from 28.3 million tonnes in 2020 to 40.9 million tonnes in 2040.

The simultaneous surge in demand for gold and copper is a fortunate coincidence for miners. While exploring for gold, they often discover copper deposits as well, allowing them to capitalize on the booming market for both metals.

A Strategic Investment

Torr Metals sits at the heart of this booming market. The company is focused on defining and developing the substantial exploration potential of the 140-square-kilometer Kolos Copper-Gold Project, located within the prolific Quesnel Terrane in Central British Columbia. Year-round access is provided by Highway 5, with the project being favorably located 23 kilometers north of the city of Merritt and 286 kilometers by highway from Vancouver. This region is particularly exciting as it is regarded as the last major remaining untested intrusive complex with a comparable geological setting to the Copper Mountain Cu-Au porphyry deposit, located 106 kilometers to the south.

Copper Mountain is legendary for its copper mining that has been going on for 75 years. Last year, Hudbay Minerals (TSX: HBM) (NYSE: HBM) paid $439 million to buy Copper Mountain Mining Corp. to boost its copper portfolio.

Historical samples from Kolos have yielded values of up to 4.24 g/t Au, 0.52% Cu, and 11.3 g/t Ag within a 7-kilometer trend of multiple untested >200 ppm Cu soil anomalies. Results are eagerly anticipated from rock samples after a ZTEM survey confirmed five significant coincident geophysical anomalies typically associated with robust hydrothermal alteration and mineralization, suggestive of deep-rooted porphyry centers, extending up to 1.5 kilometers depth.

Also in BC, Torr has its 689-square-kilometer Latham Cu-Au Project in the vaunted Golden Triangle region. Here, select 2022 rock grab samples yielded up to 14.15 g/t Au, 4.31% Cu, and 63.1 g/t silver (“Ag”) from outcrop on untested exploration targets in addition to the Gnat Pass Cu-Au porphyry deposit that remains open to expansion beyond 200 meters depth.

That is not to discount Torr’s Filion gold project in Ontario where management has already identified at least six untested exploration targets as high priority, with road-accessibility 4 kilometers north of the Trans-Canada Highway 11. Historical rock grab sampling recorded up to 9.1 g/t gold (“Au”) with channel sampling reaching 91.4 g/t Au over 0.3m, showcasing high-grade potential within a larger multi-kilometer footprint of anomalous gold in soil (up to 1.32 g/t Au) defined by the company in early 2024.

Skin in the Game

Against this backdrop, it should not come as a huge surprise that insiders are holding tight to shares of TMET. Management and associates own about 40 percent of the 35.9 million outstanding shares. They’re being rewarded as evidenced by shares of TMET going into an uptrend recently, rising from an April low of CDN$0.045 to as high as CDN$0.19 on May 15.

The bottom line here is that in the face of declining production and exhausted historical plays, new district-scale greenfield discoveries – such as those TMET is pursuing – are crucial for rejuvenating the mining industry.

The bullish outlook for gold and copper presents an exciting opportunity for investors seeking exposure to these essential commodities. For Torr Metals, this market trend translates to a strategic advantage.  By successfully developing any or all its projects, Torr Metals intends to become a new significant player in this growing market while contributing to a sustainable energy future.

For more information, visit the company’s website at www.TorrMetals.com.

NOTE TO INVESTORS: The latest news and updates relating to TMET are available in the company’s newsroom at https://ibn.fm/TMET

GEMXX Corp. (GEMZ) Expands to Oil and Gas Exploration Ventures, Creating New Strategic Partnerships in Industry

  • In an expansion of operations, GEMXX plans to finance the exploration of extensive oil reserves, specifically targeting giant fields with reserves of 500 million barrels and super-giant fields with over 3 billion barrels located primarily in Latin America
  • By leveraging a comprehensive network in the oil and gas sector, GEMXX plans to develop strong strategic partnerships and secure funding to propel exploration efforts quickly
  • GEMXX has also announced Richard Clowater as the new Chief Executive Officer and Chairman of the Board, and the appointment of Deane Preston to its Board of Directors, effective May 15, 2024

GEMXX (OTC: GEMZ), an established mine-to-market gem enterprise, has announced that the company is actively broadening its business framework to incorporate private equity funding for oil and gas (“O&G”) exploration ventures. With a large network of global relationships and several strategic alliances recently established, GEMXX is setting the stage to finance the exploration of extensive oil reserves, specifically targeting giant fields with reserves of 500 million barrels and super-giant fields with over 3 billion barrels located primarily in Latin America (https://ibn.fm/gi2e3).

This initiative represents the company’s strategy for onshore O&G exploration opportunities that balance moderate risk and high potential returns. GEMXX is focusing on basins that have been historically neglected and are significantly underexplored yet are believed, based on thorough company research, to contain substantial untapped oil reserves. By leveraging its comprehensive network in the O&G sector, which includes major global industry players, GEMXX plans to develop strong strategic partnerships and secure the necessary funding to propel these exploration efforts forward rapidly.

GEMXX is nearing the completion of negotiations to obtain financing for a bold four-well, wildcat drilling program designed to uncover significant O&G reserves. This move towards private equity funding marks a strategic expansion for the company, aiming to establish GEMXX’s footprint in the global energy landscape and maximize shareholder value through potentially high returns on investment.

According to McKinsey & Company, investments in the energy sector are estimated at $1.5 trillion in 2024. These investments are projected to grow, reaching between $2.0 and $3.2 trillion by 2040 – representing a growth of between 35% and 120%. Accelerators in the energy sector include a renewed focus on affordability, reliability, industrial competitiveness, emission reduction, and the variability across countries and regions on energy system modernization (https://ibn.fm/SbO7b).

GEMXX also recently announced that, with the retirement of Founder Jay Maull, Richard Clowater becomes the new Chief Executive Officer (“CEO”) and Chairman of the Board. In addition, the company is pleased to announce the appointment of Deane Preston to its Board of Directors, effective May 15, 2024. Preston, who has an illustrious career characterized by his deep expertise in electrical infrastructure planning, installation, and management, is set to bring invaluable perspective and leadership to the GEMXX team.

Richard Clowater expressed his enthusiasm about the appointment, stating, “Mr. Preston’s wealth of experience and proven track record in the energy infrastructure sector align perfectly with our strategic goals. We look forward to leveraging his expertise as we continue to drive innovation and excellence.”

For more information, visit the company’s website at www.GEMXX.com.

NOTE TO INVESTORS: The latest news and updates relating to GEMZ are available in the company’s newsroom at https://ibn.fm/GEMZ

Clene Inc. (NASDAQ: CLNN) Announces Key Operational Highlights as part of First Quarter 2024 Financial Results

  • Clene presented clinical data at the 2024 American Academy of Neurology (“AAN”) Annual Meeting, demonstrating that long-term CNM-Au8® treatment resulted in significant evidence of repair and remyelination across multiple paraclinical endpoints
  • Clene entered into a sub-award grant agreement with Columbia University under the previously announced National Institute of Health (“NIH”) Grant
  • Clene announced the publication of “Protein Corona Composition of Gold Nanocatalysts” in the ACS Pharmacology & Translational Science journal

Clene (NASDAQ: CLNN), a late-stage clinical biopharmaceutical company dedicated to revolutionizing the treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”), along with its wholly-owned subsidiary Clene Nanomedicine, Inc., recently announced its first quarter 2024 financial results and provided an important update on the CNM-Au8 clinical program for MS (https://ibn.fm/hfocz).

In April, Clene presented clinical data at the 2024 AAN Annual Meeting, demonstrating that long-term CNM-Au8 treatment resulted in significant evidence of repair and remyelination across multiple paraclinical endpoints. Those participants initially randomized to CNM-Au8 treatment showed continued significant improvement in vision, as measured by low-contrast letter acuity.

More than half of the participants improved by ten or more letters on a low-contrast Sloan eye chart, with increases of up to 38 letters (vs. original baseline, measured by mixed model repeat measures analysis, or MMRM; p < 0.001). Additionally, participants treated with CNM-Au8 experienced up to 29 points (max score = 110) of significant improvement in cognition and working memory, as measured by the Symbol Digit Modality Test (“SDMT”) (vs. original baseline by MMRM analysis, p < 0.001). The study also demonstrated functional and structural evidence of repair and remyelination. The results of the Visionary-MS long-term extension study, presented at the 2024 AAN Annual Meeting, are available for review.

Corporate updates provided by the company included:

  • Sub-Award Grant Agreement with Columbia University: In April, Clene entered into a sub-award grant agreement with Columbia University under the previously announced NIH Grant. The sub-award includes reimbursement of company expenses for the NIH Expanded Access Program for CNM-Au8 in ALS (ACT-EAP) of up to $7.3 million from September 25, 2023, to August 31, 2024.
  • NIH Grant Collaboration: In October 2023, Clene announced a four-year, $45.1 million grant from the NIH in collaboration with Columbia University and Synapticure, a neurology specialty health clinic. This grant is intended to support a ACT-EAP for CNM-Au8 treatment of ALS, with funds disbursed to Clene based on invoice submissions for reimbursement on a monthly or quarterly basis.
  • Research Publication: In March, Clene announced the publication of “Protein Corona Composition of Gold Nanocatalysts” in the ACS Pharmacology & Translational Science journal. This publication, in the American Chemical Society journal, highlights innovative and impactful research with translational relevance across a broad spectrum of biological sciences. The protein corona is a feature of CNM-Au8’s neuroprotective mechanism of action, enabling the drug’s longevity in circulation without provoking an inflammatory response and aiding in the drug’s transport across the blood brain barrier.

The full publication can be found at https://ibn.fm/p5pPn.

Rob Etherington, President and CEO of Clene, underscored that the company is working diligently to advance FDA discussions in ALS while continuing to generate more data supporting the neurological benefits and mechanism of action of CNM-Au8. “We look forward to a productive and collaborative FDA meeting by mid-2024 and laying the groundwork towards filing of a New Drug Application in the second half of the year,” Etherington said. “Additionally, we are very pleased to see the recent data from our long-term extension of the VISIONARY-MS study. These data represent significant evidence of repair and remyelination across multiple paraclinical endpoints and provide us with greater support for the continued clinical evaluation of CNM-Au8 for this important indication.”

For more information, visit the company’s website at www.Clene.com.

NOTE TO INVESTORS: The latest news and updates relating to CLNN are available in the company’s newsroom at https://ibn.fm/CLNN

ECGI Holdings Inc. (ECGI) Is ‘One to Watch’

  • ECGI Holdings is a diversified holding company with a distinctive portfolio comprising viticulture and luxury brands
  • The company in 2023 made a strategic investment in Pacific Saddlery, a premier manufacturer and retailer of luxury equestrian tack, apparel and accessories
  • In 2024, ECGI Holdings’ 40-acre Lake County, California, property was approved by Evolve vacation rental management as Vintner’s Caldera Ranch, a luxurious short-term rental destination
  • In 2024, the company introduced Pacific Saddlery’s new mobile retail boutique at specific equestrian events as a highlight of its future outlook

ECGI Holdings (OTC: ECGI) is a diversified holding company with a distinctive portfolio encompassing viticulture and luxury fashion. The company owns and manages a five-acre vineyard in Lake County, California, specializing in cultivating the Petite Sirah varietal, known for its bold and rich character, aligning with the growing demand for unique and high-quality wine experiences.

In the fashion sector, ECGI has strategically invested in Pacific Saddlery, a premier manufacturer and retailer of luxury equestrian tack, apparel and accessories. This unique blend of wine and fashion investments reflects ECGI Holdings’ commitment to delivering sophistication and innovation across diverse markets, positioning the company as a distinctive player in the intersection of technology, viticulture and luxury lifestyle.

Moving forward, ECGI Holdings is focused on identifying and capitalizing on growth opportunities that align with the company’s business objectives and continuing to improve its financial structure. In 2024, ECGI Holdings was approved by Evolve — a distinguished name in vacation rental management. This partnership will transform the company’s 40-acre Lake County property into a luxurious short-term rental destination aptly named Vintner’s Caldera Ranch.

ECGI Holdings is excited about the possibilities that Vintner’s Caldera Ranch creates for shareholders and looks forward to further developments poised to unlock the value of other underutilized assets. The company believes that it is laying a solid foundation for sustained success and profitability in the years to come.

ECGI Holdings is headquartered in Irvine, California.

Operational Philosophy

ECGI Holdings has embarked on an ambitious new vision and strategic direction to build and nurture luxury brands that resonate with its core values and market aspirations. Its joint venture with Pacific Saddlery epitomizes ECGI Holdings’ strategic shift toward luxury branding, leveraging Pacific Saddlery’s tangible and established market presence in equestrian products.

This transition will also allow ECGI Holdings to explore new pathways to monetize its underutilized assets, including the company’s vineyard. A key highlight of the company’s future outlook is the debut of Pacific Saddlery’s new mobile retail boutique at specific equestrian events in 2024. This innovative venture represents a significant step in ECGI Holdings’ strategy to enhance brand visibility and engage directly with the company’s target market.

In addition, the Vintner’s Caldera Ranch development marks a significant step in advancing the company’s strategy to revitalize and leverage underutilized assets. Vintner’s Caldera Ranch is set against the backdrop of Lake County’s breathtaking scenery, offering an exclusive getaway experience that blends natural beauty with luxury. Choosing Evolve is a strategic move to ensure that Vintner’s Caldera Ranch not only meets but exceeds the high standards of service that luxury guests expect.

Evolve’s expertise in maximizing rental potential and delivering exceptional guest experiences is crucial to the company’s vision of making Vintner’s Caldera Ranch a preferred choice for discerning travelers. With this venture, ECGI Holdings is not only expanding its footprint within the luxury rental marketplace, but also contributing to the local economy and enhancing the appeal of Lake County as a tourist destination.

The company’s focus remains steadfast on strategic growth, operational excellence and customer satisfaction.

Market Outlook

A report from Grand View Research, a global market research and consulting company, estimated the value of the worldwide luxury brands market at $366.23 billion in 2023 and projects the market to grow to a value of $580.43 billion by 2030, achieving a CAGR of 6.8% over the forecast period.

Rising disposable income and wealth in various regions of the world, particularly in emerging markets such as China and India, have propelled the growth of the market, according to the report.

Younger consumers, such as millennials and Generation Z, are increasingly entering the luxury market, driving demand for more contemporary and experiential luxury offerings. The rise of social media and influencer marketing has greatly impacted the visibility and desirability of luxury products, the report states.

Management Team

Jamie Steigerwald is CEO of ECGI Holdings, Inc. He is a successful entrepreneur with over 30 years of experience. Most recently, he was COO of Sugarmade Inc. (OTC: SGMD), a California cannabis real estate, cultivation, manufacturing and services company. He is the owner of SwiftLead, an Orange County web marketing, design and development company. He previously was COO for First USA Home Loans, a retail mortgage lender, and co-founder and President of SwiftLead Software, a mortgage lead tracking system.

Nick Collins is CEO at Pacific Saddlery. He brings over 25 years of expertise in equestrian luxury goods. He previously founded Rolling Meadows and created the Allon Equestrian and Renard et Cheval apparel brands. He was instrumental in creating and launching Kaval.com, an online equestrian apparel and accessories site.

For more information, visit the company’s website at www.ECGIHoldings.com.

NOTE TO INVESTORS: The latest news and updates relating to ECGI are available in the company’s newsroom at https://ibn.fm/ECGI

DGE’s 3rd Transparency & Aggregate Spend Summit to Discuss Ways to Improve Compliance and Efficiency of HCP Spend Reporting

DGE invites professionals and executives from pharma, biotech, and medical device companies, to attend the 3rd Transparency & Aggregate Spend Conference being held on June 3-4, 2024. The event is being organized by DGE in Philadelphia. With the growing need of transparency in compliance programs, the 3rd Transparency and Aggregate Spend Summit addresses the complex issues of the state, Open Payments, and global transparency reporting systems.

DGE (Dynamic Global Events), a life science leader in organizing B2B events, strives to meet the dynamic informational and networking needs of the pharmaceutical, biotechnology, healthcare, medical devices, and allied industries.

Topics of discussion:

  • CMS Keynote Address
  • Prepare for a CMS Audit
  • Improve documentation of decisions and reasoning
  • Enhance knowledge of state transparency reporting requirements
  • Navigate global compliance reporting arena
  • Ensure compliance for speaker program reporting
  • Optimize compliance monitoring
  • Uncover valuable transparency data analytics

The summit holds a discussion-based meeting format where attendees learn the latest trends for the collection, analysis, and reporting of HCP Spend data compliantly. Experts will also discuss ways of adapting to data capture, preparing audits, risk monitoring, and catering to the growing internal demand for analytics.

The event will feature the very popular interactive breakout groups dedicated to medical devices, global reporting, and collecting HCP identifying information for better acceptance submissions. (This meeting shares the same venue as AI for Life Sciences Compliance summit.)

To learn more, please visit https://ibn.fm/g6dhl.

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