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Longeveron Inc. (NASDAQ: LGVN) Validates Safety and Therapeutic Potential of its Lomecel-B(TM) Lead Investigational Product in its CLEAR MIND Phase 2a Clinical Trial

  • Longeveron, a clinical-stage biotechnology company developing cellular therapies for aging-related and life-threatening conditions, reported positive top-line results from its CLEAR MIND Phase 2a human clinical trial
  • The study, which explored Lomecel-B(TM)’s effects on mild Alzheimer’s disease, met the primary endpoint of safety on statistical and medical assessment

Longeveron (NASDAQ: LGVN), a clinical-stage biotechnology company developing cellular therapies for aging-related and life-threatening conditions, just announced positive top-line results from its CLEAR MIND Phase 2a clinical trial for treating mild Alzheimer’s disease. Most notably, the primary endpoint of safety was met based on statistical and medical assessment, with only one Serious Adverse Event (“SAE”) reported on each Lomecel-B(TM) group in what Dr. Jeffrey Cummings, MD, Vice Chair of Research, UNLV Department of Brain Health, described as “Encouraging results” (https://ibn.fm/BNOjU).

This study was designed to explore Lomecel-B(TM)’s effects on mild Alzheimer’s disease. Dubbed the CLEAR MIND trial, this randomized, double-blinded, placebo-controlled Phase 2a trial included 50 patients aged between 60 and 85 years diagnosed with mild Alzheimer’s disease. The study was conducted at ten centers in the United States, testing three different dosing regimens of Lomecel-BT(TM) vs. placebo, with patients randomized in a 1:1:1:1 ratio.

Wa’el Hashad, Longeveron’s CEO, was pleased with the results, noting how they validated the safety and therapeutic potential of Lomecel-B(TM) for treating Alzheimer’s disease.

“We believe these results provide important validation of both the safety and therapeutic potential of Lomecel-B(TM) in the treatment of Alzheimer’s disease and provide a robust foundation for additional clinical trials in this and other indications,” he noted.

Lomecel-B(TM) is Longeveron’s lead investigational product and has shown potential in anti-inflammatory and pro-vascular regenerative responses. This potential has prompted Longeveron to explore its application in aging-related chronic diseases and other life-threatening conditions under the U.S. FDA-approved Investigational New Drug applications. So far, the product has demonstrated multiple potential mechanisms of action that cover pro-regenerative, pro-vascular, anti-inflammatory, and tissue repair and healing effects, ultimately expanding its potential application across multiple disease areas.

With its success in the CLEAR MIND Phase 2a clinical trial, Longeveron hopes to continue the momentum, including announcing plans to announce additional biomarker data from the trial in November.

“We look forward to announcing additional biomarker data from this trial, anticipated in November 2024, which may further characterize the clinical effects of Lomecel-B(TM) in this study population,” noted Mr. Hashad.

In addition, Mr. Hashad shared the company’s plans for the Phase 2b ELPIS II clinical trial in Hypoplastic Left Heart Syndrome (“HLHS”), which is anticipated to be completed in 2024, and the company’s Aging-related Frailty Phase 2 program, which is currently ongoing in Japan. Combined, all these studies reflect Longeveron’s commitment to try to create shareholder value and establish its position as a leader in its segment.

Forward-Looking Statements

Certain statements in this article that are not historical facts are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which reflect management’s current expectations, assumptions, and estimates of future operations, performance and economic conditions, and involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as “believe,” “expects,” “may,” “looks to,” “will,” “should,” “plan,” “intend,” “on condition,” “target,” “see,” “potential,” “estimates,” “preliminary,” or “anticipates” or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects. Factors that could cause actual results to differ materially from those expressed or implied in any forward-looking statements in this release include, but are not limited to, statements regarding the offer and sale of securities, the terms of the offering, about the ability of Longeveron’s clinical trials to demonstrate safety and efficacy of the company’s product candidates, and other positive results; the timing and focus of the company’s ongoing and future preclinical studies and clinical trials and the reporting of data from those studies and trials; the size of the market opportunity for the company’s product candidates, including its estimates of the number of patients who suffer from the diseases being targeted; the success of competing therapies that are or may become available; the beneficial characteristics, safety, efficacy and therapeutic effects of the company’s product candidates; the company’s ability to obtain and maintain regulatory approval of its product candidates in the U.S., Japan and other jurisdictions; the company’s plans relating to the further development of its product candidates, including additional disease states or indications it may pursue; the company’s plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and its ability to avoid infringing the intellectual property rights of others; the need to hire additional personnel and the company’s ability to attract and retain such personnel; the company’s estimates regarding expenses, future revenue, capital requirements and needs for additional financing; the company’s need to raise additional capital, and the difficulties it may face in obtaining access to capital, and the dilutive impact it may have on its investors; the company’s financial performance and ability to continue as a going concern, and the period over which it estimates its existing cash and cash equivalents will be sufficient to fund its future operating expenses and capital expenditure requirements. Additionally, Longeveron makes no assurance that any public offering of its securities as described herein will occur on the timelines, in the manner or on the terms anticipated due to numerous factors. Further information relating to factors that may impact the company’s results and forward-looking statements are disclosed in the company’s filings with the Securities and Exchange Commission, including Longeveron’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the Securities and Exchange Commission on March 14, 2023 and its Quarterly Report on Form 10-Q for the second quarter of 2023 filed with the SEC on August 11, 2023. The forward-looking statements contained in this article are made as of the date of this article, and the company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

Investor Contact
Mike Moyer
LifeSci Advisors
Tel: 617-308-4306
Email: mmoyer@lifesciadvisors.com

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

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

PaxMedica Inc.’s (NASDAQ: PXMD) CEO and Corporate Communications Chief Discuss Regulatory Strategy for Lead Drug Candidate and Future Plans in Recent Bell2Bell Podcast Interview

  • PaxMedica Chairman and CEO Howard Weisman participated in a recent Bell2Bell Podcast interview and was joined by Buzz Woods from Corporate Communications
  • Weisman discussed the company’s strategy to seek FDA approval for Suramin as a treatment for Human African Trypanosomiasis (“HAT”) and plans for 2024
  • If PaxMedica is successful in getting approval in HAT, the company believes that could lead to the receipt of a Priority Review Voucher (“PRV”)
  • The company hopes to monetize the PRV to raise funds that will support research and future trials investigating Suramin as a treatment for Autism Spectrum Disorder
  • PaxMedica hopes to file an investigational new drug application to use Suramin in a large-scale trial in the U.S. in 2024

PaxMedica (NASDAQ: PXMD), a clinical-stage biopharmaceutical company specializing in innovative treatments for unmet needs in neurodevelopmental disorders, has recently introduced a groundbreaking regulatory strategy that could potentially pave the way for the approval of its lead product candidate, Suramin, in the United States. During a recent episode of the Bell2Bell (“B2B”) Podcast, Chairman and CEO Howard Weisman, along with Buzz Woods from Corporate Communications, delved into this strategy.

To hear the interview, please visit https://ibn.fm/4yGe6.

Suramin, a longstanding treatment for early-stage East African sleeping sickness (Human African Trypanosomiasis or “HAT”), has yet to receive approval for use in the United States for any indication, a gap that PaxMedica aims to bridge. Weisman underscored the crucial link between their regulatory approach for HAT and their overarching mission of addressing Autism Spectrum Disorder (“ASD”), with a specific emphasis on the role of the Investigational New Drug application (“IND”) in facilitating a large-scale study in ASD.

As PaxMedica continues to navigate the complex regulatory landscape, the company remains resolute in its commitment to drive pioneering advancements in neurology and biopharmaceutical research, particularly directed towards addressing the pressing unmet needs in the treatment of neurodevelopmental disorders.

To hear the interview, please visit https://ibn.fm/4yGe6.

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

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

Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) to Showcase Its Boutique End-to-End CDMO Services at the Premier CPHI Barcelona Event

  • Scinai will exhibit at the upcoming CPHI Barcelona event, showcasing its CDMO services
  • The company expanded into the CDMO business earlier this year, operating under the banner Scinai Bioservices
  • Scinai’s boutique end-to-end CDMO business division serves pharmaceutical, biotech, and alternative protein food tech companies with pilot and clinical process development and cGMP manufacturing
  • Scinai intends to serve small biotech companies who require CDMO services with superior value compared to large, multinational CDMO companies
  • Scinai will also exhibit at the upcoming BIO-Europe conference in Munich

Scinai Immunotherapeutics (NASDAQ: SCNI), a biotechnology company focused on developing, manufacturing, and commercializing innovative immunotherapeutic products, will be showcasing its Contract Development and Manufacturing Organization (“CDMO”) services at CPHI Barcelona, a premier three-day event that brings together pharmaceutical professionals, industry leaders, and businesses to advance human health. The event is scheduled for October 24 to 26, 2023, at Fira Barcelona Gran Via, Spain (https://ibn.fm/veEp4).

The company has been allocated Booth 81HA11, where potential partners and clients of the company’s CDMO service will get to meet several members of Scinai’s executive leadership team. Registered attendees may also request one-on-one meetings through the CPHI partnering platform.

Earlier this year, Scinai announced its expansion into the CDMO business, now operating under the banner Scinai Bioservices (https://ibn.fm/uqyUC). A boutique end-to-end CDMO service, Scinai Bioservices serves pharmaceutical, biotech, and alternative protein food tech companies with pilot and clinical process development and manufacturing.

“We decided to leverage our state-of-the-art biologics pilot manufacturing plant by commencing a new CDMO services business unit. The need for CDMO services by small biotech companies is high and growing, and the current offerings by large, multinational CDMO companies are expensive and with limited available capacity,” Amir Reichman, Scinai’s CEO, said in an August 1 news release (https://ibn.fm/UQBJ6).

According to PwC’s 2022 Global CDMO Study of Pharmaceutical Operations, only 37% of the CDMOs studied offer end-to-end services, spanning development, drug substance manufacturing, and drug product manufacturing through to packaging (https://ibn.fm/RXEWW). This statistic suggests an unsaturated market and a massive opportunity for CDMOs, such as Scinai Bioservices, that can provide end-to-end services. In fact, in the report, PwC observes that “becoming one-stop-shop solution providers can strengthen [CDMOs’] market position.”

To thrive today, PwC believes CDMOs must become full-service providers for pharmaceutical companies to differentiate themselves from competitors. This is a consideration Scinai implemented when it expanded into the CDMO business.

Scinai Bioservices provides cGMP manufacturing services with manufacturing suites that include clean rooms for upstream fermentation, downstream purification, media and buffer preparations, automatic aseptic filling to vials and prefilled syringes (“PFSs”), and labeling and visual inspection. Moreover, the manufacturing site is designed to meet the U.S. Food and Drug Administration (“FDA”) and European Medicines Agency (“EMA”) GMP standards and has previously passed audits conducted by EMA and the Israeli Ministry of Health, according to Scinai’s website (https://ibn.fm/hNKul).

The division also offers technical research and development (“R&D”) and quality control (“QC”) laboratories, which support manufacturing process development and scale-up, analytical methods development, and in-process controls and product release testing. Client companies will also benefit from Scinai’s in-house expertise and deep pharma experience.

“Our site is a perfect match for a small biotech in that it is well equipped, staffed with highly trained personnel, and its business and quality processes are in place. We see quite a lot of demand for our services and are aggressively pursuing clients. If successful, this business unit could generate meaningful income in the relatively short term,” Reichman concluded.

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

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

GolfLync Inc. Unveils Exciting Updates to Enhance Your Golfing Experience

GolfLync, the leading social networking platform for golfers, is thrilled to announce a major update to its app, bringing a host of new features members will enjoy!

Travel Mode: Play Golf Anywhere, Anytime
Golf and travel often go hand in hand, and GolfLync recognizes this synergy. The new Travel Mode allows members to change their location and seamlessly plan games, discover clubs, and connect with players in the area they are traveling to. Whether you’re on a business trip, vacation, or simply exploring new golf courses, GolfLync makes it easy to find games and like-minded golfers across the country. With Travel Mode, your golfing network knows no bounds.

My Dashboard: Golf Networking Made Easy
We’ve made it easy for members to manage all their friends, chats, games, clubs and preferences in one place. For members with hundreds of friends and followers on the APP, this makes it easy to scale your network and followers.

Verification Badges: Identify Influencers, Celebrities, and Club Hosts
We’ve taken a step further in ensuring a trustworthy and enjoyable golfing experience. Verification badges are now prominently displayed to help you identify club hosts, influencers, and even celebrities within the GolfLync community.

Virtual Golf Clubs(TM) (“VGCs”) Thrive
Virtual Golf Clubs(TM) continue to be a resounding success on GolfLync. In fact, 1 in 3 new members join a club and make connections on their very first visit. These specialized clubs cater to a wide range of interests, from specific golf courses to regional groups and more. If you haven’t explored the world of VGCs yet, now is the perfect time to discover and join clubs that align with your golfing passions. You may even want to create your own and invite your friends to join you on the APP!

Get Creative and Win Customized GolfLync Titleist Pro V1 Balls
To celebrate the GolfLync community’s creativity and love for golf, we’re giving away customized GolfLync Titleist Pro V1 balls throughout the month of November. Share your most creative video and photo posts on the APP feed, showcasing your golfing adventures, memorable moments, and unique experiences. Stay tuned for announcements and details on how to participate, and let your golfing creativity shine!

At GolfLync, our mission is to connect golfers, make your golfing experiences more enjoyable, and foster a sense of community within the golfing world. We believe these new updates will help you do just that. Whether you’re an avid golfer, a club host, or someone looking to enhance their golfing network, GolfLync is your ultimate destination.

Update your APP Today
Don’t miss out on these exciting new features. Update your GolfLync app today and experience golfing like never before. Thank you for being a part of the GolfLync community, and here’s to countless rounds of unforgettable golf!

GolfLync APPs are available for free from both the Apple Store GolfLync and Google Play GolfLync – Apps on Google Play.

For more information, visit the company’s website at GolfLync.

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

DGE 4th Next Generation MSL Excellence Summit 2023: Navigating Thought Leader Engagement in the Digital Age

DGE’S 4th Next Generation MSL Excellence Summit will be held on November 13-14, 2023 in Philadelphia, along with a live streaming option. The event revolves around offering lucrative thought leader engagement strategies to MSLs and field executives along with data, tools, and tips to engage with their audiences. As remote meetings have become the preferred means of connection and communication post-covid, strategies need to be reshaped to meet the present challenges.

The event is hosted by Dynamic Global Events (“DGE”), a Life Science leader in organizing b2b events. The global event company caters to the dynamic informational and networking needs of the Pharmaceutical, Biotechnology, Healthcare, Medical Devices, and allied industries.

Executives must join the event to strengthen technological skills and gain insights into team management. Medical affairs officers, executives & professionals from the health and pharma realm, and regulatory, research and compliance experts can attend the event to explore and learn the evolving skills that help improve team cooperation and relationship management.

Points to discuss at the summit:

  • Determine ways to engage with thought leaders to attain the best performance metrics
  • Find the best strategies for partnerships between MSLs and commercial parties
  • Leverage emotional intelligence to manage KOLs, who prefer to work remotely to gather insights
  • Best ways to achieve success as an MSL
  • Focusing on self-care and the mental health of MSLs
  • Keeping the team engaged in periods of no/little new drug information
  • Designing winning strategies for success during conferences

To know more, please visit https://ibn.fm/jiAlj

Lexaria Bioscience Corp. (NASDAQ: LEXX) Receives Two New Canadian Patents Amid Continued Efforts to Safeguard the Applicability of Its DehydraTECH(TM) Technology in Multiple Jurisdictions and Sectors

  • Lexaria has continuously taken steps to protect its intellectual property internationally to safeguard the applicability of its patented DehydraTECH(TM) technology across the globe
  • The company recently announced that it had received two new Canadian patents, increasing to 37 the number of granted patents in its intellectual property (“IP”) portfolio
  • Lexaria has filed tens of patent applications in multiple jurisdictions that are considered to have the highest commercial potential
  • The company continues to investigate opportunities that could culminate in expansions of and additions to its intellectual property portfolio and is also filing new patent applications for discoveries that arise from its R&D programs

Lexaria Bioscience (NASDAQ: LEXX) is a global innovator and biotechnology company focused on developing technology that enhances the bioavailability of multiple fat-soluble active molecules and active pharmaceutical ingredients (“APIs”). The company’s flagship technology is the patented DehydraTECH(TM) drug delivery technology, which combines fat-soluble (lipophilic) molecules or APIs with specific fatty acids and carrier compounds, improving properties such as the speed of onset, brain absorption, and bioavailability.

The company has continuously worked on DehydraTECH since 2014, with these efforts expanding the technology’s potential area of impact, both geographically and by sector. For instance, thanks to its extensive research and development (“R&D”), the company has identified viable commercial applications of DehydraTECH across several segments, including, but not limited to, cannabidiol (“CBD”) for hypertension and heart disease, treatments for dementia, hormone treatments, reduced risk non-combusted nicotine, and more (https://ibn.fm/WEejV).

“Because of the applicability of DehydraTECH to many market sectors across the globe, we have taken the necessary steps to protect that intellectual property internationally,” the company says in its 2022 Form 10-K annual report (https://ibn.fm/eE5hR). Accordingly, Lexaria has filed tens of patent applications in multiple jurisdictions with the highest commercial potential.

Lexaria believes that the successful granting of more of those applications could lead to material increases in shareholder value. The company also holds that its ability to generate meaningful license revenue from its intellectual property may increase should the remaining patent applications become granted patents.

Since 2014, Lexaria’s efforts to protect its intellectual property internationally have been paying off, with the company receiving granted patents in multiple jurisdictions. Recently, the company announced the receipt of two new patents granted by the Canadian Intellectual Property Office (“CIPO”), increasing to 37 the number of granted patents in its intellectual property (“IP”) portfolio (https://ibn.fm/IkcMG).

More specifically, the company received a new Canadian patent under its Patent Family #3: “Stable Ready-to-drink Beverage Compositions Comprising Lipophilic Active Agents.” Registered as patent #2,984,917 on CIPO’s Canadian Patent Database, the new patent recognizes Lexaria’s innovations in delivering fat-based (lipophilic) active molecules and active drugs suspended in water-based formats.

Lexaria also received Canadian patent #3,111,082 under its Patent Family #14. Titled “Lipophilic Active Agent Infused Tobacco Leaves and/or Tobacco Materials and Methods of Use Thereof,” the patent covers the company’s innovations that infuse tobacco leaves directly with active drugs or active molecules like nicotine with or without cannabinoids for such potential applications as treating nicotine addictions.

The two new patents increase Lexaria’s Canadian patent portfolio to five granted patents, following the staggered receipts of three Canadian patents over a span of less than a year. Last December, the company announced the receipt of the first granted patent in Canada, registered as patent #3,093,414 on CIPO’s database. The patent, which falls in the company’s Patent Family #6, is entitled “Transdermal and/or Dermal Delivery Of Lipophilic Active Agents.” It recognizes and protects Lexaria’s improved compositions and methods for transdermal and dermal delivery of cannabinoids such as tetrahydrocannabinol (“THC”) and CBD (https://ibn.fm/AKc5a).

In June, Lexaria announced that it had received two additional Canadian patents. The first patent is under Patent Family #1: “Food and Beverage Compositions Infused with Lipophilic Active Agents and Methods of Use Thereof,” while the second is under Patent Family #8: “Compositions Infused with Nicotine Compounds and Methods of Use Thereof” (https://ibn.fm/aUlIH).

“Our current patent portfolio includes patent family applications or grants pertaining to our method of improving bioavailability and taste, and the use of DehydraTECH as a delivery platform for a wide variety of APIs including, but not limited to, fat-soluble vitamins; anti-viral drugs; phosphodiesterase inhibitors; human hormones; regulated cannabinoids; and nicotine and its analogs,” Lexaria explains in its most recent Form 10-Q quarterly report (https://ibn.fm/gzcor). “The company has patents issued in the United States, Australia, Europe, India, Mexico, Canada, and Japan.”

Still, the company continues to investigate opportunities that could culminate in expansions of and additions to its intellectual property portfolio. Lexaria is also filing new patent applications for discoveries that arise from its R&D programs.

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

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

DGE 3rd Investigator Initiated Trials Summit 2023: Unlocking Innovations in Pharma Research and Collaboration

The 3rd Investigator Initiated Trials Summit will be held on November 13-14, 2023 in Philadelphia. The DGE event is focused on exploring the most lucrative ways for reviewing, selecting, and funding research investigators. Researchers, medical officers, health and pharma executives and companies can harness the reach and network of the DGE platform to connect with industry stalwarts and discuss vital issues on how they effectively manage IITs.

The speakers will offer important insights on ways to leverage the new methods for new indications, label expansion and potential publications. The conference aims to create a bridge between pharma suppliers and sponsors who are providing vital data and real-world evidence while remaining compliant.

The event is organized by Dynamic Global Events (“DGE”), the leading life science B2B event organizer. This event can be accessed in person and will be streamed live on a trusted interactive platform. Thought leaders, pharma professionals, researchers and leading pharma from across the spectrum will attend to discuss informative topics and form networking connections.

Key Topics Of Discussion:

  • Ways to manage costs, design contracts, and budgetary negotiations
  • Gear up resources to reach out to remote and small-population segments
  • Training and maintaining the best team to improve compliance and communications for the research trials
  • Discussing the role of MSLs in IITs
  • Discussing Collaborative Studies vs. Traditional IITs/IIRs
  • Securing operational support and valuing the well-trained admins

To know more, please visit https://ibn.fm/AOeXP

Clene Inc. (NASDAQ: CLNN) Announces Four-Year Grant to Support Expanded Access Protocol for CNM-Au8 From NINDS

  • Clene’s wholly-owned subsidiary, Clene Nanomedicine Inc., in collaboration with Columbia University and Synapticure, has been awarded a four-year grant totaling $45.1 million from the National Institute of Neurological Disorders and Stroke (“NINDS”)
  • The study will monitor safety, survival, clinical worsening, and key disease progression-related biomarkers while using CNM-Au8
  • Research conducted by Clene estimates that ALS is the most prevalent adult-onset progressive motor neuron disease, affecting approximately 30,000 people in the US and an estimated 500,000 people worldwide, with a life expectancy of diagnosed patients typically ranging from three to five years

Clene (NASDAQ: CLNN), a late clinical-stage biopharmaceutical company on a mission to transform the treatment of neurodegenerative diseases, recently announced that its wholly-owned subsidiary Clene Nanomedicine Inc., in collaboration with Columbia University and Synapticure, has been awarded a four-year grant totaling $45.1 million from the National Institute of Neurological Disorders and Stroke (“NINDS”). The grant will support an Expanded Access Protocol (“EAP”) for Clene’s investigational drug, CNM-Au8(R), for amyotrophic lateral sclerosis (“ALS”). The grant is supported by the National Institute of Health (“NIH”) grant U01NS136023 (https://ibn.fm/03fnZ).

An EAP, also called “Compassionate Use,” is an FDA-regulated pathway that allows people with serious and life-threatening diseases to access investigational drugs that have not yet been approved by the US Food and Drug Administration (“FDA”). In addition to the EAP, Clene plans to continue its current ongoing ALS EAP programs, which have enrolled more than 200 participants since 2019.

Jinsy A. Andrews, MD, MSc, FAAN, an associate professor of neurology in the Division of Neuromuscular Medicine and director of Neuromuscular Clinical Trials at Columbia University, said this EAP study will give ALS patients who don’t meet the criteria to enroll in a clinical trial an opportunity to try CNM-Au8 as a novel investigational therapy through this EAP program. “Programs like this help to advance research and much-needed innovation in ALS,” he added.

In addition to Andrews, the EAP study will be led by Eric Anderson, MD, PhD, MBA, FAAN, of Synapticure, and Benjamin Greenberg, MD, MHS, FAAN, Head of Medical of Clene. The EAP will provide eligible people living with ALS to work with clinicians to access CNM-Au8 – with access available across all 50 states, including remote and rural areas, through Synapticure’s telemedicine neurology clinic and nationwide clinics. The study will monitor safety, survival, clinical worsening, and key disease progression-related biomarkers while using CNM-Au8.

“Clene has demonstrated evidence of consistent safety and improved survival for CNM-Au8 across a broad ALS population in two independent Phase 2 trials and an ongoing EAP with up to 3.8 years of follow-up,” Greenberg stated. “This new EAP provides access to CNM-Au8 for more people living with ALS and enables the collection of survival, safety, and biomarker data in a population not studied in clinical trials. These data can help provide confirmatory support for the existing trial data Clene has gathered in its clinical trials.”

According to research conducted by Clene, ALS is the most prevalent adult-onset progressive motor neuron disease, affecting approximately 30,000 people in the US and an estimated 500,000 people worldwide. The life expectancy of diagnosed patients typically ranges from three to five years – with a high market need for treatments that affect daily function and survival. Coupled with a critical unmet need for therapeutic interventions, the EAP will provide additional support to people with ALS who did not have access to these types of drugs in the past.

“We are truly excited to be a part of this grant with Clene and Columbia and to support people living with ALS by providing access to treatments that could meaningfully impact the course of their disease,” Anderson said. “We are grateful to NINDS for recognizing how a virtual platform like Synapticure can provide expanded access programs in a remote capacity. It will allow us to reach people living with ALS across the US who have not previously had access to investigational medicines, like CNM-Au8.”

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

Electronic Servitor Publication Network Inc.’s (XESP) Focused Approach to Creating Profitable Customer Interactions

  • XESP, a market disruptor for B2B companies, is offering businesses a way to create digital customer interactions that pay off
  • Powered by its Digital Engagement Engine(TM), XESP is helping businesses avoid wastefulness while also achieving growth through its four-pronged approach
  • With its proprietary smart tools and technologies, the company offers value to its clients, allowing them to reach their customers at the right moment- when they need the client’s product or service
  • XESP is completely focused on the global customer engagement solutions market, projected to hit $32.2 billion in revenue by 2027, while also asserting itself as a leader in its segment

Electronic Servitor Publication Network (OTCQB: XESP), a market disruptor for B2B companies using cutting-edge data analysis and smart technology, is staying ahead of the curve, leveraging new and more efficient ways for businesses to drive engagement, reach bigger audiences, and build authority and credibility in their spaces. Its approach has earned it recognition from growth-focused companies and from investors.

XESP has been quick to identify inefficiencies and then provide viable and effective solutions. By focusing on eliminating wastefulness, driving growth, and helping modern businesses thrive in the evolving digital space, the company is asserting its position as a technology leader. Its revolutionary Digital Engagement Engine(TM) has been integral in achieving this objective and XESP management expects that technology will be the primary driver for the company’s continued growth.

“With our Digital Engagement Engine(TM), it’s not just about throwing everything you’ve got against the wall and hoping something sticks,” notes the company’s official communication (https://ibn.fm/X0eFT).

Instead, XESP adopts a four-pronged approach to solving the problem – data analysis, identification tech stack, tailored content, and precision delivery. With its proprietary smart tools and technologies, the company can flawlessly acquire data, allowing it to identify even the narrowest of niches for businesses’ target markets. With this information, the Digital Engagement Engine(TM) helps clients create content that meets the customers’ exact needs at the right moment when they need the client’s product or service.

The flexibility and overall potential of the Digital Engagement Engine(TM) have given XESP a significant upper hand in the digital activation and engagement space. It has allowed the company to effectively promote meaningful communication between clients and their audiences, allowing for a “laser-focused approach that makes every customer feel like you’re talking directly to them.”

Given the effectiveness of XESP’s Digital Engagement Engine(TM), businesses can now easily build new customer relationships. More importantly, they can develop real connections with their target markets, allowing for higher conversions, sales, customer retention, and overall business growth. The global customer engagement solutions market is projected to hit $32.2 billion in revenue by 2027, posting a CAGR of 10.8% from 2022. XESP looks to tap into this growth while also asserting itself as a leader in its segment.

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

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

Prospera Energy Inc. (TSX.V: PEI) (OTC: GXRFF) (FRA: OF6B) Provides Update on Drill Program; Announces Low-Dilutive Capital Raise

  • Prospera Energy recently provided an update on the second phase of the company’s restructuring plan
  • With its initial five horizontal wells and incremental crude production tracking ahead of expectations, Prospera have announced plans to continue their second phase beyond its initially mooted ten well program
  • The company has now announced that it will proceed with a low dilutive capital raise of $3 million, with proceeds destined to fund the exploration company’s ongoing capex

Prospera Energy (TSX.V: PEI) (OTC: GXRFF) (FRA: OF6B), a public oil and gas exploration, exploitation and development company focusing on conventional oil and gas reservoirs in Western Canada, recently provided the market with an update on the second phase of its restructuring program. Boasting a business model centered around optimizing hydrocarbon recovery from legacy fields through innovative production practices and seeking to exploit the over 42,000 cumulative acres of territory across the company’s core assets, Prospera designed its second phase around drilling 10 horizontal well locations at its Cuthbert and Hearty Hills properties.

The second phase of Prospera Energy’s program has quickly advanced beyond initial expectations, with the company having already successfully drilled five horizontal wells of its multi-well infill horizontal development program (https://ibn.fm/Najtv). Prospera further revealed that with two of its horizontal wells having already commenced production and the three additional horizontal wells set to commence production in subsequent weeks – the latter due to the firm’s desire to bring the wells on in a gentle way to accommodate the steady flow of the heavier viscous oil, Prospera’s gross production levels should touch 1,500 bpd by October (from 800 bpd the previous month).

With the company’s crude production tracking well ahead of initial projections and in a bid to capitalize on the current high Western Canadian Select price of $90 plus per barrel, Prospera have recently announced their intention to continue beyond their initially mooted ten well program, with the horizontal infill drilling program set to resume over the next few weeks. To finance their ongoing endeavors and upcoming capital expenditure plans, Prospera have announced a low dilutive capital raise with the company seeking to unveil a significant boost to their production capacity in the near future.

As such, Prospera Energy have announced that they will be undertaking a non-brokered private debt placement, seeking to raise gross proceeds of up to $3,000,000. Investors will be offered an interest rate of 14% per annum, with interest payments to be made quarterly for a term duration of 2 years. Separately and in addition to a quarterly coupon, debt holders will be in line to receive one common share per dollar of principal advanced at the time of investment – a measure designed to align debt holders’ interests with Prospera Energy’s significant growth ambitions. Nonetheless and in a nod to the company’s conservative capital structure program, Prospera have continued to focus on minimal dilution financing options, with the mooted capital raise plan ultimately leading to less than 1% equity dilution to the company.

Going forward and in 2023, Prospera’s corporate redevelopment strategy will continue its full-scale enhanced oil recovery (“EOR”) strategy, forecast to enhance recovery rates achieved in the ongoing second phase of the program by upwards of 10%. Additionally, the company intends to continue its acquisition strategy to diversify its product mix – with a goal of attaining a production profile comprised of 50% light oil, 40% heavy oil and 10% gas. With record growth in 2023 driving Prospera Energy’s net present value to new historical highs, the company’s designs on achieving an incremental production rate of 2,253 BPD in 2024 coupled with rapidly rising crude prices have set the stage for the company to achieve new highs in the months ahead.

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

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

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