The 11th Annual Solar & Storage Symposium at RE+ by Roth Capital Partners will held September 10-11, 2024, at the Anaheim Convention Center in Anaheim, CA. The symposium represents public and private solar and storage companies spanning the industry ecosystem. Roth Capital Partners has been organizing these symposiums since 2005, with a vision to bring industry personnel on a common forum for interaction, networking, education, and business.

The Roth symposium includes presentations, discussions, fireside chats, and small group meetings. The Roth team will conduct 40-minute one-on-one meetings between the investors and management for insights into the workings of each company. Investors can connect with the executives of 25 public and private solar and storage companies to understand their operations and goals. The symposium offers a phenomenal platform for newcomers and aspiring companies to showcase their novel ideas and latest technologies to a crowd of eminent industry investors and giant companies.

On the first day, after the conference registration and morning coffee, attendees can proceed with the small group meetings, keynote presentations, and lunch. The Roth Sustainability Team, along with RE+, is organizing the Oktoberfest Networking Reception. The highlight of day two is the company fireside chats with senior research analyst Phil Sen.

At the symposium, leaders and investors in the solar and storage industry arena will share their invaluable ideas and insights that will shape the future. Startups can learn important strategies and trends by participating in group discussions and chats.

Roth conferences offer companies and investors from different industry verticals the opportunity to connect and develop long-term business relationships. Participants, sponsors, and presenting companies all get maximum exposure. Investors discover new talent while companies can explore growth and business opportunities at the Roth Symposium.

This is an invite-only event. Registration is subject to approval.

To learn more, please visit https://ibn.fm/eZv8e

• SenesTech recently issued new unregistered warrants and closed on an exercise of certain existing warrants, raising approximately $2.3 million in aggregate gross proceeds
• The company plans to use the proceeds of the warrant exercise to continue with its rollout of the Evolve(TM) product line (Evolve Rat and Evolve Mouse), the industry’s only soft bait product line to control rodent populations by restricting fertility
• The company’s Evolve products, controlling rodents through rodent birth control versus poisons, represent safer alternatives to second-generation rodenticides, which threaten numerous species that ingest poisoned rodents, contaminated feces, contaminated soils, and sometimes the poisoned baits themselves
• The U.S. Environmental Protection Agency is expected to come up with tighter regulations on second-generation poisons, positioning SenesTech for continued growth as demand increases

SenesTech (NASDAQ: SNES), the leader in fertility control to manage animal pest populations, recently issued new unregistered warrants to purchase up to an aggregate of 1,011,004 shares of common stock at $4.35 per unit in a private placement. The company also closed on an exercise of certain existing warrants to purchase 505,502 shares of its common stock at a reduced exercise price of $4.60 per unit, raising approximately $2.3 million in aggregate gross proceeds. SenesTech intends to use the net proceeds from this transaction for working capital and general corporate purposes (https://ibn.fm/o12H7).

“In a simple sense, we believe that the proceeds allow us to continue with our rollout of the Evolve(TM) product line. We believe that this financing will enable us to execute these plans,” said Joel Fruendt, SenesTech President and CEO.

Evolve(TM) Product Line

SenesTech introduced Evolve(TM) soft bait for rats in October 2023 as a superior solution for effective rodent control. The product contains cottonseed oil, an active ingredient extracted from cotton plants. The compound, SenesTech says, interferes with the reproductive systems of both male and female rats, restricting their fertility using different approaches.

In male rats, Evolve reduces sperm count, motility, and viability. In female rats, it disrupts estrous cycles (the recurring patterns of ovarian activity during the rats’ reproductive phases), affects follicles (sacs inside the ovaries that house growing eggs), and reduces pregnancy rates. These effects, which are both dose and time-dependent, help control rat populations.

To expand its addressable market, SenesTech introduced in May the Evolve(R) Mouse, a mouse product that uses the company’s breakthrough fertility control solution. “We would expect the market for a mouse product would at least double the addressable market for the Evolve product line,” conveyed Fletcher Cline, President of DIY Pest Control, one of SenesTech’s distributors and online retailers (https://ibn.fm/gZ2N8).

The appeal of SenesTech’s Evolve Rat and Evolve Mouse products is driven by numerous factors. First, both products are designated as ‘minimum risk’ by the U.S. Environmental Protection Agency (“EPA”), under FIFRA 25(b), meaning they pose little or no risk to human health and the environment. Secondly, according to Fruendt, the Evolve product line is a viable alternative to historical lethal methods for rodent infestations, which are failing and are under increased scrutiny for their impact on food webs.

Negative Impact of Second-Generation Rodenticides

The second-generation poisons are anticoagulants, blocking the blood’s ability to block. They cause death by triggering internal bleeding, with the same fate befalling predators or scavengers that eat the poisoned rodent, especially if the quantity of poison ingested is large enough. The poisons may also indirectly cause death by predisposing predatory birds to collide with a vehicle or fly into a building.

The supporting evidence exists: A 2023 draft evaluation by EPA, for instance, found that rodenticides, including second-generation compounds, threaten numerous species of animals, from predatory birds such as hawks, eagles, and owls to animals like wolves, foxes, skunks, and coyotes. Additionally, rodent poisons have also been detected in cockroaches, beetles, geckos, shellfish, snails, slugs, and dead frogs, which may have eaten poisoned prey, contaminated soil, contaminated rodent feces, and, in some instances, the poisons (https://ibn.fm/pVIqK).

The already devastating consequences of using these rodenticides are compounded by their long half-lives. Some testing suggests that the second-generation poisons can remain in rat livers for almost a year post-ingestion before losing potency. This trait eliminates any time-dependent poisonous attribute, predisposing predators and scavengers to harm regardless of when they actually feed on the poisoned rodents.

These poisons have also been shown to pose a threat to children because of the potential for accidental poisoning of people. In light of this revelation, the EPA in 2008 imposed rules banning the sale of second-generation rodenticides in settings where nonprofessionals could purchase them. They must also be sold in large quantities. The rules, however, had loopholes that still ensure accessibility for many consumers. As concerns continue to mount, the EPA has proposed tighter restrictions and is undertaking an evaluation that will guide the future use of these poisonous compounds.

Better Alternatives

But, as the country awaits EPA’s decisions and potential restrictions, it is increasingly becoming clear that rodents can be controlled without poisons. Edible compounds that reduce fertility are an available and viable alternative approach alongside snap traps and ecologically based rodent management.

For its part, SenesTech holds that its Evolve product line is the industry’s only soft bait product line to control rodent populations by restricting fertility. In this regard, the company is ideally positioned as the rodent control market looks for safer alternatives to poisons. And in recognizing the impact of rodent control products on food chains and webs, SenesTech has engineered the Evolve product line to pose no risk to non-target animals.

According to SenesTech, the low active levels in Evolve are designed for the body mass of rats and mice, “so larger mammals would need to repeatedly ingest a substantial amount over several weeks to see any effects.” Additionally, the company has observed that birds appear more tolerant because they have different intestinal tracks and modes of digestion (https://ibn.fm/OSJWd).

To tap into future and emerging opportunities while catering to its addressable market, SenesTech’s R&D team is continuously working on improving its products. “Future iterations may incorporate different active ingredients or enhanced formulations based on ongoing research and feedback,” the company says.

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

• The company reports the successful production and completion of four workovers, along with increased gas production capacity, at its Black Sea asset
• “This early return on our investment is a clear indicator of the field’s robust production potential,” notes the CEO

Trillion Energy International (CSE: TCF) (OTCQB: TRLEF), a company focused on oil and natural gas production for Europe and Türkiye, is marking a significant milestone in its strategic perforation program. The company reports the successful production and completion of four workovers, along with increased gas production capacity, at its Black Sea asset (https://ibn.fm/GEzxE).

“The wells on the Akcakoca Platform have been completed successfully with gas production and well head pressure (‘WHP’) continuing to increase,” stated Trillion Energy CEO Arthur Halleran. “This early return on our investment is a clear indicator of the field’s robust production potential. The results are very positive, giving us good indications that decreasing the production tubing size from 4-1/2 inches to 2-3/8 inches, using velocity strings, should stabilize gas production at the targeted rates.”

In the production update for the SASB gas field, the company noted that the SASB revitalization program was “off to a great start, having realized the complete payback of recent perforation costs in just 35 days of production.” The report noted that, in the first phase of the workover, all remaining gas pay on the Akcakoca platform was perforated, including three long-reach deviated gas wells (Guluc-2, South Akcakoca-2 and West Akcakoca-1) and a complete legacy well, Akcakoca-3.

“The wells started production over a staggered period from July 9 to July 28 and have already produced 140 million cubic feet (‘MMcf’) representing a 35-day payoff of the recent perforation CAPEX,” the report observed. “South Akcakoca-2 has been producing for 36 days, stabilizing at approximately 2.75 MMcf per day. Guluc-2 has produced an average production of 2.0 MMcf/d for over three weeks and now produces at a stable rate of about 1.25 MMcf/d. West Akcakoca-1 has produced an average of 0.60 MMcf/d for over two weeks with some irregularities and has not yet stabilized.”

The company noted that Akcakoca-3 was perforated, and while gas flow did not initially occur, the WHP has steadily increased from 100 psi to 478 psi. The company anticipates that the well will start producing soon. The company also reported that gas production from the Akcakoca Platform has averaged 4.6 MMcf/d since the perforation program ended.

In addition, Trillion announced that its board of directors authorized the granting of stock options under its Stock Option Plan to specified company directors, officers, employees and consultants. The approval is for the purchase of 8,800,000 common company shares at $0.14 per share for a five-year term, set to expire on Aug. 12, 2029.

Trillion Energy International is focused on oil and natural gas production for Europe and Türkiye with natural gas assets in Türkiye. The company holds a 49% interest in the SASB natural gas field, a Black Sea natural gas development, and a 19.6% (except three wells with 9.8%) interest in the Cendere oil field. Trillion Energy is also pursuing oil exploration in southeast Türkiye and beyond.

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

• INM-901 oral formulation shows encouraging results in preclinical studies
• High bioavailability of INM-901 oral formulation was shown to provide similar drug concentration levels in the brain as intraperitoneal injection
• Oral delivery method offers advantages such as lower treatment costs, in comparison with intravenous delivery of large molecule antibody therapies
• The company is conducting further research including drug metabolism studies, dose ranging studies and pharmacokinetic studies

InMed Pharmaceuticals (NASDAQ: INM), a clinical stage pharmaceutical company focused on developing a pipeline of proprietary small molecule drug candidates targeting the CB1/CB2 receptors, announced that its drug candidate INM-901 as an oral formulation will be used in its development programs for Alzheimer’s disease following encouraging results obtained in preclinical trials (https://ibn.fm/D99wp).

INM-901 is a small molecule drug candidate that demonstrated multiple pharmacological effects in preclinical studies including neuroprotective effects, extending the length of neurites which is important for brain cell-to-cell communication, as well as reducing neuroinflammation. These preclinical studies were conducted in well-characterized study models of Alzheimer’s disease.

Recent preclinical studies further showed that INM-901 can be administered orally, with the same therapeutic effects in the brain as intraperitoneal injections. INM-901 oral formulation was shown to maintain similar drug exposure levels as intraperitoneal injections over a 24-hour period. Oral delivery offers multiple advantages, including an overall reduction in treatment delivery costs compared to intravenous delivery of large molecule antibody therapies currently administered in such cases.

Large molecule antibody therapies are difficult to formulate orally and also present significant challenges to gastrointestinal tract absorption and further blood stream delivery, which is why IV or subcutaneous delivery methods need to be used instead. Additionally, large molecule therapies come with significant side effects, such as brain inflammation and bleeding, which requires constant monitoring and regular brain scans.

InMed Pharmaceuticals is confident INM-901 oral formulation can address these issues by achieving better absorption in the GI tract and in the blood stream, effectively penetrating the blood-brain barrier, in addition to ease of administration and higher accessibility to patients.

“We are excited by the recent data confirming that INM-901 can be delivered across the blood brain barrier to the brain tissue as an oral formulation which provides significant advantages for further development of this compound in the treatment of Alzheimer’s,” said Michael Woudenberg, InMed’s Chief Operating Officer and SVP of Chemistry, Manufacturing and Controls. “Similar drug levels in the target tissue are not usually seen between oral versus IP delivery. The supporting data generated by the oral formulation provides an attractive therapeutic approach given the many challenges associated with delivery of drug(s) to the brain.”

The company is already conducting further research for the drug candidate substance and the product formulation, including dose ranging, drug metabolism and pharmacokinetic studies in view of submitting INM-901 for investigational new drug status with the Food and Drug Administration.

The Alzheimer’s therapeutics market is projected to grow significantly in the coming years, driven by an aging global population and increasing prevalence of the disease. In 2022, the market was valued at $4.05 billion, and is expected to grow at a compound annual growth rate of 19.99% from 2023 to 2030, with a growing demand for effective therapies that can halt or slow the progression of the disease (https://ibn.fm/NeIBV).

Given the current landscape, the positive preclinical results of INM-901 position InMed Pharmaceuticals as a potential leader in the development of promising, innovative treatments for Alzheimer’s. The formulation’s success could mark a significant advancement in Alzheimer’s care, offering hope to millions of patients worldwide.

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

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

• Platinum group metals (“PGMs”) are a special selection of six critical metals—platinum, palladium, rhodium, osmium, iridium and ruthenium—that are essential for a sustainable future
• Most PGMs are being mined from a single area in South Africa
• The Waterberg Project, operated by Platinum Group Metals, is projected to be one of the largest and lowest-cost PGM mines globally

Platinum Group Metals (NYSE American: PLG) (TSX: PTM), a company that operates the Waterberg PGM Project in South Africa, is strengthening its foothold in a niche sector of mining: platinum group metals (“PGMs”). The company’s primary business objective is to advance the Waterberg Project to a development and construction decision.

“Platinum group metals, or PGMs, are a very special selection of six metals [platinum, palladium, rhodium, iridium, osmium and ruthenium] that we find in the periodic table,” reported Sarah Gordon, cofounder of Critical Productions, a company that believes raw materials are essential for a sustainable future (https://ibn.fm/RVXBI). “They’re special because we find them in catalytic converters — so, in the exhausts of our vehicles — and they’re there because they help take out some of the nastier emissions generated by our combustion engine, so they don’t go into the atmosphere.

“We can also use PGMs in things like medicine,” Gordon continued. “They are great at forming different component parts of different medical implements within our bodies. They’re also a key component part of hydrogen power, so by pumping them through these membranes, you get hydrogen and you get oxygen, and then we use the fuel cells that also require the PGMs to be able to combine them back together again. So that’s where we get the power in hydrogen power.”

The report noted that the supply of PGMs is limited, with most PGMs being mined from a single area in South Africa, with smaller producers in Russia and the United States. The Waterberg Project, operated by Platinum Group Metals and projected to be one of the largest and lowest-cost PGM mines globally, is located on the Northern Limb of the Bushveld Complex in South Africa. The project was discovered by Platinum Group in 2011 and is planned as a fully mechanized platinum, palladium, rhodium and gold mine, including byproduct copper and nickel production.

“PGMs are critical for pollution control in the automotive sector, including traditional internal combustion engines (‘ICE’) and the growing gasoline hybrid and plug-in hybrid (‘PHEV’) segments,” states Platinum Group. “PGMs also play a critical role in fuel cell technology and the production of hydrogen.”

The Waterberg Project is a joint venture between Platinum Group, integrated PGM producer Impala Platinum Holdings Ltd. (OTCQX: IMPUY), Japanese consortium HJ Platinum (which includes trading house Hanwa Co. and the government-backed Japan Organization for Metals and Energy Security) and empowerment partner Mnombo Wethu Consultants (Pty) Ltd. Platinum Group has an effective 50.22% interest in the Waterberg Project.

For more information, visit the company’s website at www.PlatinumGroupMetals.net.

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

• Nightfood Holdings Inc. has expanded beyond its core business of healthier late-night snacks by acquiring Future Hospitality Ventures, specializing in game-changing technologies for the hospitality industry
• The acquisition aligns with Nightfood’s mission to identify and exploit explosive market trends within the hospitality, foodservice, and consumer goods sectors
• Nightfood’s aggressive approach positions it at the intersection of food and technology, driving growth opportunities in both its traditional and newly ventured markets

Nightfood Holdings (OTCQB: NGTF) is the pioneer in providing sleep-friendly nighttime snacks.

The company’s recent acquisition of Future Hospitality Ventures marks a strategic pivot, as it aggressively expands beyond the food sector and into the broader service industry, specifically the Robot-as-a-Service (“RaaS”) market. According to Grand View Research, the global RaaS market size was estimated at $1.05 billion in 2022 and is expected to grow at a compound annual growth rate of an impressive 17.5% from 2023 to 2030.

Now, Nightfood is close to finalizing an acquisition of CarryOutSupplies, a reemerging provider of innovative packaging solutions to foodservice and hospitality providers with millions in annual revenue and an aggressive growth plan.

Let’s explore the opportunities and upside of these recent transactions.

Addressing Industry Challenges with Robotic Automation

The acquisition of Future Hospitality Ventures is a significant step for Nightfood as it broadens its operational scope. This strategic alignment allows Nightfood to tap into new revenue streams and diversify its business portfolio. Most importantly, the company is set to be a first mover in the massive foodservice and hospitality industries, which are both experiencing radical tectonic transformation due to unstoppable outside forces.

Future Hospitality Ventures specializes in innovative technologies like robotic automation to solve existential challenges in the foodservice and hospitality industries. These include a decimated workforce, skyrocketing labor costs, and vanishing margins. By integrating automation solutions, Future Hospitality helps their hospitality and foodservice clients survive and thrive through streamlining operations, enhancing efficiency, and ultimately, improving the overall customer experience.

Robotic automation can handle complex tasks such as increasing food production, enhancing order processing, food preparation and delivery. This frees up valuable human staff to focus on higher-level tasks such as planning and customer interactions, ensuring more efficiency and improved customer experience.

Daily headlines show us that operators in foodservice and hospitality are currently being forced to adapt or go extinct.

Nightfood’s Future Hospitality delivers the technological solutions shaping the future of these massive industries.

Synergy with Existing Products

While NGTF hasn’t mentioned cross-selling opportunities, there’s a potential connection between its existing product line and its new service ventures. The company’s focus on healthy snack options and pending wholesale business align with the hospitality industry’s trend towards offering better-for-you food choices. Nightfood could leverage its brand recognition to propose integrated solutions for restaurants and hotels, offering both tech-driven operational improvements and healthier snack options to cater to health-conscious consumers.

A Trend Towards Service-Tech Integration

Nightfood’s expansion into hospitality technology reflects the new harsh realities in the service industry. Companies either adapt to the new tech, or they die. There is no third option.

Nightfood’s acquisitions of Future Hospitality and CarryOutSupplies reflect the company’s overarching value proposition to shareholders: To identify and exploit explosive market trends within the hospitality, foodservice, and consumer goods sectors. By leading newly emerging categories and by identifying opportunities in existing markets undergoing transformational upheaval, Nightfood’s goal is to create upside potential unmatched in more mature markets.

For more information, visit the company’s website at https://nightfood.com.

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

The MoneyShow Powerful Investing & Trading Strategies Virtual Expo was successfully conducted from Aug. 20 to Aug. 22, 2024. Traders, investors, and market leaders from across the globe were invited to share the online conference space, providing and receiving actionable financial advice. Proven market leaders shared insights on how traders and investors can adapt to changing market conditions to generate maximum profits.

Operational for the last 43 years, MoneyShow brings traders and investors to common forums in-person and online for interaction, networking, and collaboration. MoneyShow hosts conferences and expos where financial experts give critical advice that helps investors safeguard and strengthen their portfolios. Participants get access to robust financial tools, the latest news, and a massive content library on investing and trading.

Each MoneyShow Virtual Expo offers an interactive experience for traders and investors from all across the world. The events feature LIVE presentations from influential experts where attendees can directly chat with them.

The August expo also offered an interactive educational platform for investors and traders, one where they could connect in one-on-one meetings to get an in-depth understanding of each other’s vision and operations.

Attendees learned the best strategies to adapt to a volatile environment and smartly expand their portfolio. Industry experts gave insightful strategies on which stocks, ETFs, and other asset classes to invest in for potential capital appreciation. Industry leaders, investors, traders, and colleagues connected to discuss the best ways to maximize profits and boost their investment value.

In addition, the MoneyShow online conference featured virtual booths that housed message boards, findings of the latest research, educational content, prize offers, and more. Participants could access the downloadable educational material and store all data in one place.

To learn more, please visit https://ibn.fm/pbi4d

• Company has resumed exploration on the project, including surface soil sampling and a prospecting campaign
• The exploration program is “designed to lay the groundwork for a future stripping program at Parbec”
• Current MRE is outdated; any future MRE calculated at Parbec will benefit from the inclusion of the new and historic drilling

Renforth Resources (CSE: RFR) (OTCQB: RFHRF), a mineral exploration company engaged in the acquisition, exploration and development of mineral properties in Canada, is reporting on the status of its wholly owned Parbec gold deposit (https://ibn.fm/WFiVB). According to the company, exploration has resumed on the project, including surface soil sampling and a prospecting campaign targeting the southwest portion of the property.

The exploration program is “designed to lay the groundwork for a future stripping program at Parbec, while also investigating previously unexplored areas in the Pontiac sediments, helping to identify additional potential areas for stripping and sampling,” the report stated. “Based on prior surface sampling and drill results, there are two identified target areas for future stripping: the northwest section of the property and the central ‘turning point’ area east of the ramp collar, where the gold-bearing felsites are exposed at surface. Both areas have been previously worked and have yielded surface gold numbers.”

In addition, the company noted that it will sample waste rock generated during the development of the decline. The development, which targeted the hanging wall of the Cadillac Break, was advanced in the early 1980s. “Currently, the decline, which did not reach its goal, is inaccessible and flooded,” the company observed. “However, it did intersect gold-bearing lithologies that were not sampled at the time. Renforth believes it is worthwhile to analyze the untested waste rock that has been stored on-site.”

Parbec is located on the Cadillac Break, Canada’s most productive gold-bearing structure. This very deep structure runs between Kirkland Lake in Ontario and Val d’Or in Quebec, a length of more than 250 km. Next door to Parbec is the Canadian Malartic mine, Canada’s largest open-pit gold mine, located on a proven structure near many gold mines, with road access, power and all the services required to develop the property. This location is very advantageous and cost effective for Renforth.

According to the report, Parbec Gold Deposit hosts a mineral resource estimation (“MRE”) that is not up to date. Since the last calculated MRE, dated May 2020 but effective in December 2019, Renforth has drilled 15,000 meters of new holes, which extended the mineralization within the MRE further down and on an infill basis within the resource model.

“In addition to this, the 2020/21 drilling is considered to have validated an additional 13,000 meters of historic drilling, which Renforth does not have the witness core for, so it was excluded from the 2020 MRE,” the company reported. “The validation of the historic results occurs as 10% of the historic holes were redrilled, with results comparable to the historic hole in terms of geology and gold values in the new holes compared to the old. Any future MRE calculated at Parbec will benefit from the inclusion of the new and historic drilling.”

In addition to its Parbec Gold Deposit Project, Renforth Resources is developing its wholly owned, approximately 330 square kilometer Malartic Metals Package. This project’s surface mineralization includes nickel, cobalt, copper, zinc, silver, gold and lithium in several locations.

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

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

• Clene is pioneering a very unique approach to the treatment of neurodegenerative diseases such as ALS and MS with the use of an oral nanotherapeutic that can be easily administered
• The company has submitted CNM-Au8 biomarker and efficacy data to the Food and Drug Administration in a Type C meeting request, seeking approval to file a new drug application using the accelerated approval pathway for ALS
• CNM-Au8 has the potential to impact the ALS therapeutic market, as CNM-Au8 can help increase and improve survival rates and delay clinical worsening in ALS patients
• In MS, CNM-Au8 can work in conjunction with current treatments to improve vision, cognition, and global neural function in MS patients, potentially capturing a significant portion of the MS market as well

Clene (NASDAQ: CLNN), a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, was recently featured on The BioMedWire Podcast, highlighting the important results of CNM-Au8 trials for both amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”), and plans for the future (https://ibn.fm/6OOO1).

During the podcast, CEO Rob Etherington explained that Clene is focused entirely on improving mitochondrial health and protecting neuron function, which is “the most important thing we can do to treat neurodegenerative diseases such as ALS, MS, and Parkinson’s.”

Etherington added that having safe and effective therapies to improve function in neurodegenerative disease patients is essential and topical, as the World Health Organization is predicting that neurodegenerative diseases will become the second-most prevalent cause of death within the next two decades. “We’re pioneering a very unique approach: the use of an oral suspension that patients can drink to treat the deficits that they might have if afflicted with one of these devastating neurodegenerative diseases,” he said.

In fact, this approach is one of the key things that set Clene apart from the competition, Etherington said. “Nobody else has theorized that you can drink an oral nanotherapeutic, and that it would do two specific things: improve the mitochondrial dysfunction that is endemic with these diseases, and improve or increase the nicotinamide adenine dinucleotide pathway which is compromised in neurodegenerative diseases.”

Etherington also explained that there is an exigent need for effective therapies for ALS and MS that can improve function, which is something CNM-Au8 has been shown to do in several clinical trials.

“ALS is historically known as Lou Gehrig’s disease, famously named after the baseball player who contracted it in the 1930s. From there, it took 60 years for the first ALS drug to be approved by the FDA, approved in 1995 and still remains today, nearly three decades later, the standard of care. There’s obviously a tremendous need for new drugs in ALS. In the case of multiple sclerosis, there are a lot of drugs that can treat MS, but they all do effectively the same thing: they tamp down the body’s immune response, so the body stops attacking itself. What they don’t do is improve function – the way patients move and walk and talk and think cognitively with MS,” he said.

CNM-Au8 hopes to capture a significant share of the $26 billion therapeutic market for MS, by working in conjunction with existing treatments to enable the energetic capacity that patients’ neurons require to function. In the case of ALS, where the therapeutic market is considerably smaller, CNM-Au8 can help increase and improve survival rates and delay disease progression.

Clene recently announced results of two independently conducted Phase 2 clinical trials, RESCUE-ALS and HEALEY ALS Platform Trials, where participants saw improvement in survival rates and delays in clinical worsening, defined as first occurrence of death (or death and permanent assisted ventilation), tracheostomy, need for invasive ventilatory support, or feeding tube placement. Previous studies investigating CNM-Au8 for MS (Repair-MS and Visionary-MS) also showed significant improvement in global neurological function and vision in stable MS patients, Etherington said.

The company has submitted CNM-Au8 biomarker and clinical efficacy data to the Food and Drug Administration in a Type C meeting request, seeking approval to file a New Drug Application (“NDA”) using the accelerated approval regulatory pathway for ALS. A response is expected in the third quarter of 2024. If this accelerated pathway is approved, the next steps will be to file an NDA by the end of the year and to launch a confirmatory global Phase 3 study in ALS.

Etherington also discussed CNM-Au8’s potential as a treatment for other neurodegenerative diseases, including Parkinson’s, Rett syndrome, frontal temporal dementia and Huntington’s, explaining that the drug’s mechanism of action could benefit patients with these conditions as well. The company is also looking at potentially expanding into other disease areas with other therapies once it begins commercializing CNM-Au8, the Clene CEO added.

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

• Transdermal alcohol detection solutions provider SOBRsafe is implementing strategies to further strengthen its financial position
• During Q2 2024, the company eliminated $2.6 million in debt and improved its balance sheet with a capital infusion from the exercise of warrants
• SOBRsafe has increased its revenue by 44% from Q2 2023 as it continues to onboard new customers in 2024

SOBRsafe (NASDAQ: SOBR), the provider of next-generation transdermal alcohol detection solutions, has continued to implement plans and strategies to strengthen its financial position and restructure shareholder equity throughout the second quarter of its 2024 financial year, according to its recent Q2 2024 quarterly update (https://ibn.fm/ZWPa8).

In June the company entered into a Warrant Inducement agreement. The execution of the agreement provided the company with gross proceeds of approximately $2.8 million and net cash proceeds of approximately $2.4 million in exchange for the exercise of 10,319,163 applicable warrants to common shares and issuance of 20,638,326 new plain vanilla warrants to subscribe for and purchase from the company a similar number of shares (https://ibn.fm/63YRz).

The company also settled its remaining debt balances by converting outstanding notes payable into 4,358,957 shares of common stock. Terming these efforts as “very positive developments for the future of SOBRsafe,” Dave Gandini, CEO and Chairman, noted that the company had “significantly strengthened” its balance sheet with the infusion of capital and elimination of $2.6 million in debt.

“With the execution of the company’s strategy to strengthen the balance sheet through the acquisition of liquidity and reduction in future debt obligations, exchange of equity units with unfavorable terms to those conducive to our growth, and in retaining the company’s public market listing, we continue to fortify our financial position and improve our ability to raise capital in the future,” said SOBRsafe CFO Christopher Whitaker in the Q2 2024 update.

In addition to providing a comprehensive update on the status of its financial positioning, SOBRsafe shared its sales progress. In the second quarter of 2024, the company secured 17 customer accounts and, as a result, grew its 2024 new customer count to 33 new accounts, compared to three accounts booked in 2023. The new customers have driven SOBRsafe’s revenue up 44% compared to Q2 2023 figures, to $54,191.

Among the 17 new Q2 customer accounts are two new behavioral health customers, a Texas-based integrative care provider and a Colorado-based recovery services provider, who signed a hardware/software agreement with SOBRsafe (https://ibn.fm/NtsSF). Others include LightHouse Recovery Resources and Mountain House Recovery (https://ibn.fm/Rn44l) as well as a three-facility behavioral health provider (https://ibn.fm/fs4fG), all of whom signed hardware/software agreements.

The recent agreements exemplify the company’s focus on the growing behavioral health market and the progress made since entering this market late last year. “We first entered our core market of behavioral health in Q4 2023, where our technology is re-inventing the continuum of care by reducing redundancy, eliminating paper trails, creating digital records, improving billing processes, and most importantly, creating more time and focus for clinical practice,” said Gandini in the Q2 2024 quarterly update. “Consistent with our sales strategy, we are earning validation in the behavioral health market.”

Gandini noted that the validation it is progressively earning is the “first and most important step” in building its industry brand. Additionally, he went on, it “empowers the range of continued customer adoption – from single location providers with fewer than 25 patients to providers with multiple facilities and larger patient populations.”

SOBRsafe’s growing list of customers relies on its eponymous transdermal technology, which detects and instantaneously reports the presence of alcohol as emitted through a person’s skin. Unlike traditional alcohol monitoring and screening solutions, SOBRsafe’s technology does not require breath, blood, or urine samples.

The company’s alcohol detection technology is fitted into SOBRcheck, its point-of-care alcohol screening device, and SOBRsure, its continuous alcohol monitoring wristband. The technology is also supported by a powerful backend data platform that enables real-time reporting and, depending on the device, GPS tracking.

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

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