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Lexaria Bioscience Corp. (NASDAQ: LEXX) Validates Technology’s Superiority, Moving Closer to a Share in the Global Diabetes Treatment Market

  • Lexaria, a global innovator in drug delivery platforms, just reported positive results from its applied research program conducted in collaboration with the National Research Council of Canada (“NRC”)
  • The study’s objective was to examine the molecular properties of semaglutide, processed with its patented DehydraTECH(TM) technology, comparing it to Rybelsus(R), the commercially available alternative
  • Lexaria’s DehydraTECH demonstrated that semaglutide can be efficiently released in a simulated gastric fluid environment, without the use of salcaprozate sodium (“SNAC”) ingredient chemistry
  • This milestone moves the company closer to the diabetes treatment market, projected to hit $153.98 billion in value by 2032

Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, just released findings from its applied research program that sought to evaluate the mode of action facets of its patented DehydraTECH(TM) technology and the glucagon-like peptide 1 (“GLP-1”) drug, semaglutide. The program was conducted in conjunction with the National Research Council of Canada (“NRC”), with the management terming the findings as “positive” (https://ibn.fm/sVTtW).

This marks a significant milestone for Lexaria, mainly since it builds upon its growing dataset around DehydraTECH amenability to GLP-1 formulation and oral delivery performance. In addition, it demonstrates DehydraTECH’s versatility and superiority, notably since the study achieved the desired outcomes without the proprietary salcaprozate sodium (“SNAC”) ingredient chemistry.

The results are significant, since published literature describing Rybelsus(R) noted that it occurs in simple monomeric form in the human gut. This presence has been attributed to SNAC, and the property has been known to allow the permeation of the gastric epithelium to deliver GLP-1 drugs into the bloodstream. Lexaria’s study clearly showed that semaglutide was efficiently released in the simulated gastric fluid environment. In all the cases, it was likely in monomeric form, a form previously achieved using the SNAC technology.

To realize this objective, Lexaria and the NRC team examined the molecular properties of DehydraTECH-processed semaglutide in comparison to the commercially available semaglutide formation, Rybelsus(R). They further used simulated gastric fluid, mimicking conditions in the human gut. In addition, they leveraged various testing methods such as dynamic light scattering (“DLS”), electrospray ionization mass spectrometry (“ESI-LCMS”), polyacrylamide gel electrophoresis (“PAGE”) and size exclusion chromatography (“SEC”).

The findings from this study offer a glimpse into Lexaria’s future. At the beginning of the year, its management noted its commitment to doubling down on GLP-1 studies for 2024, promising to make the year its biggest one yet. This milestone affirms this commitment while highlighting what is in line for Lexaria and its DehydraTECH technology. More importantly, it demonstrates the technology’s potential and versatility,  in delivering various orally administered bioactive molecules more effectively (https://ibn.fm/bhtjL).

Lexaria is making decent headway as it works toward carving out market share in the diabetes treatment market. In 2023, this market was valued at $79.25 billion. It is set to grow to $153.98 billion by 2032, representing a CAGR of 7% over the forecast period (2024-2032) (https://ibn.fm/xSc7M). Lexaria has several additional R&D studies underway, including both animal and human investigations into semaglutide, liraglutide and tirzepatide. Together, those three drugs represent more than 90% of all revenue in the current global GLP-1 market.  Its management is bullish about its current direction and is confident that its efforts will pay off in due time.

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

SuperCom Ltd. (NASDAQ: SPCB) Reports Q2, H1 Earnings Growth, Record Profit

  • Electronic monitoring solutions company SuperCom Ltd. provides a suite of products and services to justice system officials worldwide, promoting public safety through the secure tracking of individuals who require supervision
  • SuperCom’s PureSecurity technology has the ability to serve a wide variety of tracking purposes but is specifically targeting electronic monitoring of offenders, including domestic violence cases, drug rehabilitation services, and probation orders
  • The company recently reported its second quarter and first half financial results, noting growth across multiple metrics, including record profits following a 65.2 percent surge in gross profit and 20.4 percent growth in gross profit margin
  • SuperCom’s EBITDA grew by 83 percent in the quarter, and by 182 percent for the first half of the year

Electronic monitoring (“EM”) technology innovator SuperCom (NASDAQ: SPCB) is celebrating impressive developments in 2024, reporting “substantial improvements” in its gross profit, operating income, and net income as it secures new orders and contracts from government and judicial system clients.

SuperCom’s technology development and deployment are strategically focused on providing EM tools for tracking offenders supervised by nations’ crime prevention and rehabilitation infrastructures. The company also provides solutions for a variety of e-government identification services, but its advanced safety technology platform can serve private organizations as well.

The company’s efforts have resulted in a Q2 surge in gross profit (65.2 percent) for a new company record, with net income growth of 183 percent over the previous quarter, according to a news release issued in conjunction with an investor conference call conducted by SuperCom’s executive team August 15.

“Our strategic focus on cost optimization and capital management, combined with our innovative approach to technology deployment, has driven a significant turnaround in our bottom line,” CEO Ordan Trabelsi stated (https://ibn.fm/kjQ4W). “Our ability to reach gross profit margins of nearly 50% as we advance through various stages of our projects is a testament to the efficiency of our operations and the high-margin nature of our offerings.”

The financial report notes that the sales moved SuperCom’s cash flow, net income, and EPS into positive territory, accompanied by 83 percent growth in EBITDA from $0.9 million to $1.6 million.

For the first half of the year, EBITDA improved by 182 percent to $3.6 million, with the gross profit margin nearly doubling to 52.3 percent, operating income improving by $2.8 million, and the net income margin improving to 20.6 percent.

“The recent business wins, including over $11 million in new orders from European governments and several significant new contracts in North America, highlight our leadership in the public safety sector and our ability to penetrate new markets with our cutting-edge solutions,” Trabelsi stated. “Particularly noteworthy is our successful displacement of long-time incumbents in the judicial sector, showcasing the superiority of our PureOne technology. … We are excited about the opportunities ahead and believe in our ability to maintain our momentum.”

The PureSecurity GPS-based suite of hardware, connectivity, and software components is adapted for secured communication. It supports discreet wearing so that monitored individuals can move about the community freely without concerns about the social stigma that might be attached to more obvious ankle monitor devices.

Electronic monitoring doesn’t just improve the community’s safety. It also helps offenders’ function within society in a gainful manner, retaining employment and maintaining a presence within their families while reducing criminal recidivism.

“EM improves the educational attainment and early-life earnings of the children whose parents were exposed to the reform,” a research analysis published by the Journal of Public Economics stated earlier this year (https://ibn.fm/StiyW). “Our calculations suggest that the social benefits stemming from EM are about seven times larger than the fiscal savings associated with reduced prison expenditures, implying that the welfare gains from EM could be much greater than previously acknowledged.”

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

ECGI Holdings Inc. (ECGI) Following Proven Path from High-End Equestrian Market to Full-Scope Luxury Market

  • Many renowned luxury brands – fashion houses and watchmakers – honor their equestrian roots and the strong relationship with horses, from Rolex and Longines to Burberry, Gucci, Hermès, and Ralph Lauren
  • The companies, which have successfully remained in operation for decades and continue to be influenced by equestrian elements, underscore the proven potential of the luxury equestrian market to build large-scale luxury players
  • Beyond an equestrian influence, leading fashion houses emphasize and embody quality, unmatched craftsmanship, and innovation, qualities that ECGI Holdings and its subsidiary Pacific Saddlery have adopted
  • A diversified holding company, ECGI Holdings intends to cater to the growing demand for high-quality equestrian apparel through its new collection under the Allon brand, building to broader luxury sectors

In 1901, the then-45-year-old Burberry, now a renowned British luxury fashion house, ran a public competition seeking a winning entry that would become the new logo for the company. The winning entry was the equestrian knight design (“EKD”), a testimony to the company’s relationship with its communities. The EKD depicted an armor-clad knight riding a horse while wielding on one hand a shield emblazoned “B” and on the other, a banner that reads ‘Prorsum’ (Latin for ‘Forward’) (https://ibn.fm/ogj1n).

Since then, the EKD symbol underwent several transformations, with Burberry recently reviving it under the auspices of Daniel Lee, its new creative director, as part of the company’s rebranding efforts. Burberry’s equestrian-inspired logo is one of a few prominent logos that feature a horse and its rider – the others being Hermès and Ralph Lauren.

Founded in 1837 as an artisanal atelier, Hermès (OTC: HESAF) initially made harnesses before expanding its products to include saddles. Today, the company is multifaceted, producing and selling a wide range of luxury goods, apparel, equestrian accessories, and more. Even so, the company has remained true to its roots, retaining its logo depicting a man standing before a carriage-pulling horse (https://ibn.fm/oT69S).

For its part, Ralph Lauren (NYSE: RL) has used its now iconic logo, which depicts a Polo player riding a horse, since the 1970s. The logo tells a larger but perhaps obvious story: equestrianism has been one of the company’s foremost influences. The influence, according to Ralph Lauren, started during the early life of its founder and now permeates to the products the company designs, produces, and sells (https://ibn.fm/DEWju).

For other luxury brands, however, the equestrian influence is not captured in their respective logos but in their products. These include Gucci, which is now part of Kering Group (OTC: PPRUF), and luxury watchmakers Longines, a part of The Swatch Group AG (OTC: SWGAF), and Rolex. Emblematic of their love for equestrianism, the latter two have long partnered with organizers of equine sports competitions around the world to ensure accuracy in sports timekeeping.

The long-standing equestrian histories of these luxury fashion houses and watchmakers point to the lucrativeness of their strong relationships with horses. It is this success, which transcends decades and centuries, that captured the attention and interest of ECGI Holdings (OTC: ECGI), a diversified holding company with a portfolio encompassing viticulture and luxury fashion.

This interest is supported by market research by analysts at Global Market Insights, who forecast that the global equestrian apparel market will reach $9.7 billion by 2032 from $6.5 billion in 2023, representing a 4% CAGR (https://ibn.fm/OmNeU). They also predict that the global equestrian equipment and tack market, valued at $11 billion in 2023, will grow at a 4.3% CAGR to $17 billion in 2032 (https://ibn.fm/1Jj10). Combined, the global equestrian market is expected to be valued at $23.5 billion in 2032 from $17.5 billion in 2023.

To tap into this expected growth while simultaneously acquiescing to its new-found interest, ECGI Holdings strategically invested in Pacific Saddlery Inc., a company that manufactures and sells luxury equestrian tack, apparel, and accessories. The investment is captured in a binding Letter of Intent (“LOI”) announced in June 2024 (https://ibn.fm/bCZvg).

Together, ECGI Holdings and Pacific Saddlery have launched a ready-to-wear equestrian apparel collection under the Allon brand. This collection is intended to cater to the growing demand for high-quality equestrian apparel, aligning with ECGI Holding’s strategy to expand its presence into the luxury equestrian sector (https://ibn.fm/Htnls).

With luxury houses continuously demonstrating that the key to longevity and success, besides the relationship with equestrianism, is innovation, unmatched craftsmanship, and quality, ECGI Holdings and Pacific Saddlery are committed to walking down this proven path, all while cherishing and honoring the influence of horses on fashion.

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

Annovis Bio Inc. (NYSE: ANVS) Announces Encouraging Clinical Trial Results, IP Portfolio Enhancement

  • The company has released key corporate and business updates and Q2 2024 financial results
  • Clinical trials for both Alzheimer’s and Parkinson’s studies yielded encouraging data for lead compound buntanetap
  • Buntanetap in combination with GLP-1 agonist dulaglutide Trulicity(R) showed increased potential to synergistically enhance cognition
  • The company has obtained a patent and begun manufacturing of a new crystalline form of buntanetap, with improved properties

Annovis Bio (NYSE: ANVS), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer’s disease (“AD”) and Parkinson’s disease (“PD”), offered key business updates and announced financial results for the second quarter ended June 30, 2024. The company reported productive recent months, with encouraging data on lead compound buntanetap’s performance in two pivotal studies, according to Maria Maccecchini, Ph.D., Founder, President, and CEO (https://ibn.fm/hc6L4).

“We’ve completed pivotal Phase 2/3 Alzheimer’s and Phase 3 Parkinson’s studies, both of which revealed very encouraging data for buntanetap,” Maccecchini said. Buntanetap works by targeting multiple pathways involved in neurodegenerative diseases. It inhibits the production of neurotoxic proteins that lead to the death of neurons, thereby slowing or stopping disease progression.

Alzheimer’s Disease Clinical Trial:

Data from a Phase 2/3 AD study was released on April 29, showing that buntanetap significantly improved cognition in patients with early AD, with a 3.3-point improvement on the ADAS-Cog11 test after three months of treatment, compared to a 0.3-point improvement in the placebo group.

A later analysis on June 11 demonstrated that buntanetap was effective in improving cognition among high-risk APOE4 carriers, showing a 3.15-point improvement. It also showed that buntanetap was as safe in APOE4 carriers as non-carriers, a huge advantage over existing disease-modifying therapies.

Parkinson’s Disease Clinical Trial:

Data from a Phase 3 PD clinical trial was released on July 2, indicating that buntanetap led to significant improvements in both the Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) and cognition across several PD subpopulations.

Buntanetap showed a strong response in individuals diagnosed with PD for more than three years as well as in those with postural instability and gait disorder (“PIGD”). The lead compound was also found to halt cognitive decline in all enrolled patients and improved cognition in those with mild dementia.

Combination Trial with GLP-1 Agonist Dulaglutide:

On August 6, Annovis Bio released preclinical data demonstrating that its lead compound, buntanetap, synergistically enhances  cognition beyond normal levels, when used in combination with the glucagon-like peptide 1 (GLP-1) agonist dulaglutide (Trulicity(R)) in a mouse model of AD.

New Patents:

The company introduced a new crystalline form of buntanetap with improved properties, further strengthening its IP portfolio. The new crystalline form offers significant advantages over the less structured, old semi-crystalline form, including better solubility and stability as well as an additional 20 years of patent life.

Annovis Bio filed a provisional patent for the manufacturing of this crystalline form.

The company was also granted a patent from the US patent office for using buntanetap for acute traumatic brain injury treatment. The company now has worldwide rights for buntanetap in acute neurodegeneration.

The company received approval from the Food and Drug Administration to continue the development of this new form of buntanetap.

“These milestones position us strongly as we move closer to providing much-needed treatments to patients,” Dr. Maccecchini said, commenting on the business updates.

These encouraging results will enable the company to capture a significant share of the neurodegenerative disease treatment market, an expanding sector driven by an aging population and increasing incidence of conditions like AD. Alzheimer’s care costs are expected to reach $360 billion in 2024 and grow to nearly $1 trillion annually by 2050 (https://ibn.fm/3EpPm).

For more information, visit the company’s website at www.AnnovisBio.com, and social channels
LinkedIn, X and YouTube.

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

InMed Pharmaceuticals Inc. (NASDAQ: INM) Reports Promising Long-Term Results for Alzheimer’s Drug INM-901

  • A long-term preclinical study of Alzheimer’s Disease (“AD”) drug candidate INM-901 included four groups: untreated disease-free, INM-901-treated disease-free, placebo-treated Alzheimer’s Disease, and INM-901-treated Alzheimer’s Disease at two dosing levels
  • The results showed that INM-901-treated AD groups displayed behavior trends similar to the untreated disease-free group, with a clear dose response observed in most assessments
  • The drug has also shown a reduction in neuroinflammation and enhancement of neuronal function, with molecular data supporting behavioral study observations

InMed Pharmaceuticals (NASDAQ: INM), a biopharmaceutical company focused on developing proprietary small molecule drug candidates for diseases with high unmet needs, has announced promising outcomes from a long-term preclinical study of its Alzheimer’s Disease (“AD”) drug candidate, INM-901. These new findings confirm and expand upon results from a previous short-term pilot study (https://ibn.fm/eASUI).

The long-term study, conducted over seven months, utilized the 5xFAD amyloidosis model, extending the dosing duration and increasing the sample size compared to the earlier three-month study. The study included four groups: untreated disease-free, INM-901-treated disease-free, placebo-treated Alzheimer’s Disease, and INM-901-treated Alzheimer’s Disease at two dosing levels. Given the progressive nature of the disease in this model, the groups in the long-term study exhibited more advanced AD than those in the short-term pilot.

The study assessed several behavioral criteria across the four groups. Cognitive function and memory were evaluated using the Novel Object Recognition Test, while general locomotor activity was measured through the Open Field Test. Anxiety-related behavior was gauged using the Elevated and Zero Maze Tests, spatial learning and memory were assessed with the Barnes Maze Test, and sound awareness was tested with the Acoustic Startle Test.

The results showed that INM-901-treated AD groups displayed behavior trends similar to the untreated disease-free group, with a clear dose response observed in most assessments. Significant improvements in specific behavioral criteria were noted compared to the placebo-treated AD groups, reinforcing and in some cases exceeding the outcomes of the short-term study.

Dr. Eric Hsu, Senior Vice President of Preclinical Research and Development at InMed, expressed optimism about the findings. “We are highly encouraged by the initial data from this long-term study, which supports the improvements in behavioral outcomes observed in our initial short-term preclinical Alzheimer’s proof-of-concept study. INM-901 continues to show potential by targeting multiple biological pathways associated with Alzheimer’s Disease, addressing the critical need for effective treatments,” Dr. Hsu added.

To better understand the mechanisms of action and the potential role of INM-901 in AD treatment, InMed is conducting further molecular analyses. These analyses will focus on receptor engagement (CB1/CB2 and PPAR), neuroinflammation (levels of various cytokines and inflammatory marker proteins), neurogenesis (markers for neuronal differentiation and function), and neuroprotection (evaluating stress responses and cellular growth/survival).

In addition to these analyses, the development of the chemistry, manufacturing, and controls (“CMC”) for both the drug substance and product formulation is ongoing. GLP studies are in the planning stages to support an IND submission.

Research and development activities to date have demonstrated that INM-901 targets several biological pathways associated with AD, exhibiting positive pharmacological characteristics. These include preferential signaling agonism for CB1/CB2 and impacts on PPAR signaling pathways, blood/brain barrier penetration with potential for oral administration, neuroprotective effects against amyloid-beta-induced cytotoxicity, and promotion of neurite outgrowth, indicating potential improvement in neuronal function.

The drug has also shown a reduction in neuroinflammation and enhancement of neuronal function, with molecular data supporting behavioral study observations. InMed Pharmaceuticals continues to advance its research on INM-901, aiming to address the urgent need for effective Alzheimer’s treatments.

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

SenesTech Inc. (NASDAQ: SNES) Building Quickly Across Multiple Channels

  • SenesTech recently released Q2 2024 financial results and hosted a conference call, confirming 50% revenue growth in the just-ended quarter, and year-to-date growth 62%
  • During the call, Joel Fruendt, President and CEO, discussed the company’s progress and accomplishments, including the successful efficacy trial of Evolve to support the product’s approval in certain states and international jurisdictions
  • Fruendt also discussed the company’s commercialization plans, centered around the pivot from the reliance on direct sales to the use of distributors
  • So far, SenesTech has onboarded three of the top five national multi-location distributors and is in the process of bringing the fourth on board
  • The company has active international agreements, is pursuing the agribusiness industry, is keen on penetrating the retail market through sales agencies, and has ramped up efforts to ensure the availability of its products on various e-commerce platforms

SenesTech (NASDAQ: SNES), the inventor of ContraPest(R), the only U.S. EPA-registered contraceptive for male and female rats, as well as Evolve(R) and Evolve Mouse(R), EPA-designated minimum risk contraceptives for rodents, recently reported financial results for its second quarter of fiscal 2024, ended June 30, 2024. In addition, Joel Fruendt, President and CEO of SenesTech, and Tom Chesterman, CFO of SenesTech, hosted a conference call (https://ibn.fm/1MQaT).

During the conference call, Fruendt discussed SenesTech’s progress and accomplishments. He highlighted that Evolve, the revolutionary fertility control product formulated to control rat pests, has now been approved for sale in 44 states. Additionally, Evolve Mouse, which uses the same active ingredient as Evolve but is specifically made for mice, is currently available for sale in 32 states. According to Fruendt, the Evolve Mouse product effectively doubles the company’s obtainable market.

Additionally, during the past quarter, the company completed an efficacy trial of Evolve at an Arizona university, demonstrating the efficacy and sustainability of the product. Required by some states and international jurisdictions, the study generated results that, according to Fruendt, were better than expected.

The results showed a 61% reduction in litter size after one breeding round and a 90% reduction over the course of 12 months. Fruendt highlighted that this “represents a substantial reduction in population,” considering that two rats or mice can grow to 15,000 in just one year. As with Evolve, SenesTech intends to conduct a trial to evaluate the efficacy of Evolve Mouse, conforming with the requirements of some states.

“Moving from product development to commercialization, we have pivoted our selling efforts [from a reliance on a direct sales model] to a distribution model, where we target larger orders and a lower cost of sales. The Evolve product line allows the shift in a way that ContraPest could not – through a substantial shelf-life, ease of use, and lower installed costs. We are continuing to expand into the international market, which is also only possible with the Evolve product line,” continued Fruendt.

The shift from the direct sales model has seen the company onboard three of the top five national multi-location distributors and is onboarding the fourth. In addition, SenesTech has active international agreements in 11 countries so far, with these agreements requiring an upfront purchase and increasing annual sales to maintain exclusivity. In four of the 11 countries, SenesTech is either conducting pivotal trials to gain full registration, with distributors working extensively with government agencies, or already in the market.

In addition to international markets, SenesTech is pursuing the agri-business industry. The company is engaging in direct discussions with “very large agricultural operations” and agricultural distributors, which signal increasing interest from companies in this space. “We currently have 4 stocking national distributors in this area and are onboarding two more,” Fruendt continued.

SenesTech is also keen on penetrating the retail market and is working with five sales agencies that have over 50 reps in the field and sell to 23 retail co-ops and big box chains representing over 50,000 locations. These accounts, Fruendt noted, include the largest of the big box operators and retail warehouses.

In addition, Fruendt touched on the company’s efforts to leverage e-commerce to grow its revenue. Accordingly, SenesTech is selling its products on its own website, Amazon.com, and DIYpestcontrol.com. The company also has entered agreements to onboard two of the largest third-party e-commerce platforms in the current quarter, including tractorsupply.com and Walmart.com, and has targeted six more.

The company believes the efforts of the past quarter will turn into revenue this quarter and the next, continuing a growth trend – SenesTech’s revenue in the just-ended quarter grew 50%, while the year-to-date growth stood at 62%. In addition, revenues for the first six months of 2024 were $874,000 compared to $538,000 for the same period in 2023. This growth, Chesterman explained, was driven by the Evolve product line, which was launched at the beginning of the year and is already 59% of total sales.

In his concluding remarks, Fruendt expressed his excitement at the progress the company has made thus far, noting, “We’re just starting to hit the point where a lot of the work we’ve done over the past nine months is really going to start taking hold across these different channels that we talked about, and we should have more really good news to report going into the balance of this year.”

To listen to the webcast replay, visit https://ibn.fm/rhZOa (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

Clene Inc.’s (NASDAQ: CLNN) CNM-Au8(R) Affects Key Biomarkers and Long-term Survival in ALS Trials

  • Two Phase 2 independently conducted clinical trials showed significant improvement in key biomarkers among ALS patients who were administered CNM-Au8
  • Biomarker and efficacy data was submitted to the Food and Drug Administration for a granted Type C meeting request, with the company targeting an accelerated approval pathway
  • CEO Rob Etherington expressed optimism about CNM-Au8’s potential as a new ALS treatment, and voiced hope that ALS patients will benefit sooner rather than later
  • Clene recently presented its latest updates and findings at the Canaccord Genuity 44th Annual Growth Conference

Clene (NASDAQ: CLNN), a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, announced positive results of two independently conducted Phase 2 clinical trials, RESCUE-ALS and HEALEY ALS Platform Trials, of CNM-Au8 for the treatment of amyotrophic lateral sclerosis (“ALS”) (https://ibn.fm/ktu4u).

The new CNM-Au8 biomarker and clinical efficacy data was submitted to the FDA to supplement original data submitted in late 2023 and is intended to guide the granted FDA Type C interaction expected in the third quarter of 2024 to discuss an accelerated approval regulatory pathway, according to a company press release.

One of the key biomarkers of ALS disease progression and mortality risk is the level of neurofilament light (“NfL”) in plasma. Participants in the HEALEY ALS Platform Trial with substantial NfL declines saw significant improvement in survival rates, functional status, and combined assessment of function and survival, compared to NfL non-responders.

Independent of NFL responder status, participants who underwent long-term treatment with CNM-Au8 at a dose of 30 mg were found to have improved survival rates, both in the RESCUE-ALS and the HEALEY ALS Platform Trials, using updated long-term follow-up of survival status, the CLENE announcement said.

The two clinical trials also revealed consistent nicotinamide adenine dinucleotide (“NAD”) and glutathione improvements with CNM-Au8 treatment, associated with participants who were NfL responders, supporting a dual mechanism of action of neuronal metabolic support and decreased oxidative stress, and indicating target engagement in ALS patients.

The strong safety profile of CNM-Au8, with NfL biomarker response now linked to survival evidence, and new information on mechanisms of action, support proceeding to a confirmatory Phase 3 clinical trial and regulatory discussions on approval pathways, according to Merit Cudkowicz, M.D., Chair, Neurology Department, Massachusetts General Hospital, Director, Sean M Healey & AMG Center for ALS, and the Principal Investigator of the HEALEY ALS Platform Trial.

With more than 650 patient years of safety data, CNM-Au8 continued to show a robust safety profile without any observed safety signals or any significant safety concerns or adverse effects identified by any investigators to date. “The risk-benefit assessment evidence of CNM-Au8 is strong. Our next step is discussing this new CNM-Au8 biomarker and efficacy data with the FDA, with the hope that ALS patients will benefit from this drug, sooner rather than later,” said CEO and President of Clene, Rob Etherington.

Clene also shared its latest findings and positive developments at the Canaccord Genuity 44th Annual Growth Conference & Private Company Showcase, on August 13. During the conference, the company presented its latest data and discussed its strategic plans with investors and also hosted one-on-one investor meetings. The conference provided Clene with an opportunity to engage with stakeholders and showcase its innovative approach to treating neurological disorders. The company emphasized its commitment to advancing CNM-Au8 through the clinical development pipeline and ultimately bringing it to market.

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

National Investment Banking Association 150th Investment Conference Comes to Ft. Lauderdale, Florida

The National Investment Banking Association (“NIBA”) invites the micro-cap and small-cap investment community to its 150th investment conference. The event will be held on September 4-5, 2024, at the Westin Fort Lauderdale Beach Resort, Ft. Lauderdale, Florida.

Since 1982, The National Investment Banking Association has been a not-for-profit association for the micro-cap and small-cap investment community and has hosted 149 investment conferences featuring public and private micro-cap and small-cap companies seeking access to the financial industry.

NIBA’s member firms have a 40 year track record of successfully completing thousands of transactions totaling over $80 billion in new capital for emerging growth companies and are responsible for 90% of all IPOs under $20 million.

The investment conference will be held at the beautiful Westin Fort Lauderdale Beach Resort, offering top-notch hospitality with splendid ocean views. The beach resort is well-connected to the cruise port and the airport, offering the best business and recreational experiences.

The NIBA investment conference features global leaders and executives gracing the event floor. They will share their knowledge and offer insights into the latest trends, cutting-edge technologies, and regulations that shape the finance industry. The main agenda of the event is to showcase small-cap and micro-cap industries to the investment community for growth and funding opportunities. Investors can leverage the platform to discover fresh talent with promising business prospects.

Companies will hold presentations to gain exposure among a wide audience of potential investors and investment bankers. Investors can connect with relevant company heads in one-on-one personal meetings to understand the company’s vision and goals. Small-cap companies can pitch their business ideas and develop networking connections at these meetings. The NIBA investment conference brings CEOs, company executives, and investors on a forum that fosters networking, education, friendships, and partnerships.

To learn more, please visit https://ibn.fm/PlN2Q

D-Wave Quantum Inc. (NYSE: QBTS) Reports Strong Q2 2024 Results

  • The company reported a 28% increase in revenue, a 6% rise in bookings, a 97% improvement in GAAP gross profit and a 444% increase in cash, for the second quarter of 2024, on a year over year basis
  • D-Wave’s CEO, Dr. Alan Baratz, summarized the company’s ongoing strategic direction and provided an expansive list of achievements
  • Highlights mentioned include a quantum AI product development roadmap extending D-Wave’s Leap(TM) quantum cloud service, an expanded partnership with Zapata AI, new customer hybrid quantum applications, and more

D-Wave Quantum (NYSE: QBTS), a leader in quantum computing systems, software, and services, and the first commercial provider of quantum computers, released its second quarter 2024 financial results along with recent business and technical updates. The company reported growth in key areas, reflecting its continued momentum in the quantum computing market (https://ibn.fm/DNZ11).

D-Wave has made notable progress in advancing its quantum computing offerings and expanding its market presence during this period. The company announced an updated product development roadmap designed to enhance its Leap quantum cloud service to address artificial intelligence (“AI”) and machine learning (“ML”) applications. In addition, D-Wave has focused on developing strategic partnerships to further strengthen its market position, including with Zapata AI.

Key business highlights of Q2 2024 include:

  • Quantum AI product development roadmap that extends the Leap quantum cloud service for AI and ML.
  • Expansion of commercial partnership with Zapata AI, designed to accelerate the development and delivery of integrated quantum and generative AI solutions, as part of the roadmap.
  • Announcement of the forthcoming placement of a second U.S.-based Advantage(TM) quantum computer, which will be D-Wave’s fourth production quantum computer and accessible via the Leap quantum cloud service.
  • Launch of a new hybrid quantum solver for nonlinear programs, enabling customers to solve real-world problems with support for up to two million variables and constraints.
  • Successful production of the company’s tenth Qubits quantum computing user conference in June 2024, with more than 600 attendees representing 452 organizations from 50 countries.
  • Development with customers on a variety of hybrid quantum applications including Ford Otosan (vehicle production optimization application) and Hermes Germany (vehicle routing quantum optimization application).
  • Double-digit enrollment growth for quantum training courses in the first six months of 2024.
  • Joining the broad-market Russell 3000 Index, which captures the 3,000 largest stocks as of April 30, 2024, ranked by total market capitalization.

D-Wave’s Q2 2024 results also underscore its robust performance across several financial metrics:

  • Number of customers increased to a total of 130 for the four fiscal quarters ended in Q2 compared to 114 customers in the immediately prior four quarter period, including 77 commercial customers and 26 Forbes Global 2000 customers.
  • Revenue was $2.2 million, an increase of $0.5 million, or 28%, from the fiscal 2023 second quarter revenue of $1.7 million. Revenue from commercial customers increased by 35%, or $1.8 million. Revenue from Forbes Global 2000 customers increased by $0.9 million, or 50%, and comprised 26% of total revenue.
  • Bookings for the second quarter of fiscal 2024 were $2.7 million, an increase of $0.2 million, or 6% from the fiscal 2023 second quarter bookings of $2.5 million. This is the company’s ninth consecutive quarter of YoY growth in quarterly bookings.
  • GAAP gross profit was $1.4 million, an increase of $0.7 million, or 97%, from the fiscal 2023 second quarter gross profit of $0.7 million, an increase primarily driven by the growth in revenue and improved operating efficiencies.
  • Ended the second quarter with $40.9 million in cash, one of the company’s highest quarter-end cash balances in history.

Dr. Alan Baratz, CEO of D-Wave, expressed optimism about the company’s growth trajectory and future prospects in light of the Q2 results, indicating continued traction on all fronts – revenue, bookings, customer acquisition, liquidity and technical advancements. “There is rapidly growing awareness of annealing quantum computing and its ability to deliver business benefits today, and the market is responding. This is further strengthened by our product development activities in hardware (Advantage2(TM) prototype), software (new nonlinear hybrid solver and fast anneal feature), and Quantum Artificial Intelligence,” Dr. Baratz added. “Our momentum as one of the few companies in the world leading the quantum transformation is evident.”

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

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

Forward Looking Statements

Certain statements in this press release are forward-looking, as defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks, uncertainties, and other factors that may cause actual results to differ materially from the information expressed or implied by these forward-looking statements and may not be indicative of future results. These forward-looking statements are subject to a number of risks and uncertainties, including, among others, various factors beyond management’s control, including the risks set forth under the heading “Risk Factors” discussed under the caption “Item 1A. Risk Factors” in Part I of the company’s most recent Annual Report on Form 10-K or any updates discussed under the caption “Item 1A. Risk Factors” in Part II of the company’s Quarterly Reports on Form 10-Q and in the company’s other filings with the SEC. Undue reliance should not be placed on the forward-looking statements in this press release in making an investment decision, which are based on information available to us on the date hereof. The company undertakes no duty to update this information unless required by law.

Sprout Social Inc. (NASDAQ: SPT) Appoints New Chief Revenue Officer to Accelerate Global Growth

Sprout Social (NASDAQ: SPT), a frontrunner in cloud-based social media management software, recently made headlines with the appointment of Mike Wolff as its new Chief Revenue Officer. This strategic move is aimed at bolstering Sprout Social’s global sales, success, and partnerships organization, with a keen focus on accelerating the company’s worldwide growth and expansion. Wolff’s extensive background, notably his transformative tenure at Salesforce, underscores his proficiency in scaling sales operations and driving substantial revenue growth. His transition to Sprout Social is poised to leverage his two decades of experience in steering global sales and technology teams towards achieving ambitious growth targets.

Sprout Social’s commitment to expanding its global footprint and enhancing its software offerings is further emphasized by Wolff’s enthusiasm for the role social media plays in connecting consumers with brands. His ambition to contribute to Sprout Social’s growth and deliver unparalleled value to its customers aligns with the company’s mission to provide top-tier social media management tools. This synergy between Wolff’s vision and Sprout Social’s objectives sets a promising trajectory for the company’s future endeavors.

The financial metrics of Sprout Social reveal a company in a unique position within the market. Despite a negative price-to-earnings (P/E) ratio of approximately -26, indicating current unprofitability, the company’s price-to-sales (P/S) and enterprise value to sales (EV/Sales) ratios suggest a market willing to invest in its growth potential. These figures, coupled with a significantly high enterprise value to operating cash flow (EV/OCF) ratio, reflect investor confidence in Sprout Social’s capacity to generate value through its operations over time.

Moreover, the company’s moderate debt-to-equity (D/E) ratio of about 0.29 signals a balanced approach to leveraging debt for growth, while the current ratio of approximately 0.89 points to a slight challenge in managing short-term liabilities with its assets. These financial indicators provide a nuanced understanding of Sprout Social’s operational and financial health, offering insights into the challenges and opportunities that lie ahead as it embarks on its next phase of growth under Mike Wolff’s leadership.

In summary, Sprout Social’s strategic appointment of Mike Wolff as Chief Revenue Officer marks a significant step towards achieving its global expansion and growth objectives. His proven track record in scaling sales and technology organizations, combined with Sprout Social’s robust platform serving over 30,000 brands, positions the company for continued success in the dynamic social media management sector. The financial metrics underscore the market’s optimism about Sprout Social’s future, despite the challenges of achieving profitability, highlighting the company’s potential for long-term value creation.

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

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