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Seanergy Maritime (NASDAQ: SHIP) Raises Dividend Following Record-Breaking Q2 And H1 Results, United Maritime (NASDAQ: USEA) Rises Through Strategic Investments

Benzinga

By Gerelyn Terzo, Benzinga Seanergy Maritime Holdings Corp. (NASDAQ: SHIP) reported a record-breaking second quarter, with performance extending through the first half of the year. To reward shareholders, the U.S.-listed, Athens-based company boosted its quarterly dividend and introduced a new payout policy, underscoring its commitment to driving growth and delivering value to investors. Seanergy Maritime, a leading pure-play Capesize ship owner, is sailing at peak performance in 2024. The company’s 18-vessel fleet, including 1 Newcastlemax and 17 Capesize vessels, has driven record results. In Q2 2024, Seanergy posted a net income of $14.1 million, a fresh all-time high which compares with $700,000 in the year-ago period. For the first half of 2024, net income surged to $24.3 million, a major turnaround from the $3.5 million loss in the same period last year. Q2 net revenue soared by 52% year-over-year to $43.1 million, while H1 revenue grew by 75% to $81.4 million. Earnings per share reached $0.68 for Q2 and $1.18 for H1. Seanergy's reported financial fundamentals have led the board to enhance its dividend policy, aiming to deliver even more value to shareholders. With a focus on distributing around 50% of operating cash flow after debt payments, the company boosted its Q2 cash dividend to $0.25 per share – up from $0.15 and $0.10 in the previous two quarters. This move continues their commitment to rewarding investors, having already returned $34.7 million in cash dividends since Q1 2022. Seanergy continues to boost shareholder value by resuming stock buybacks. The company repurchased $1.8 million worth of shares at an average price of $10.56 per share, under its $25 million share repurchase plan launched in December 2023. Chairman and CEO, Stamatis Tsantanis revealed he has been scooping up common shares and call options in the open market, with plans to acquire more SHIP stock in the upcoming quarters. “Based on our strong and visible cash flow generation, we expect to be able to continue returning significant capital to our shareholders in the coming quarters,” he said. Investors who might want to join in can learn more about Seanergy’s stock performance here. Seanergy’s Results Driven by Strategic Moves Seanergy’s CEO, Stamatis Tsantanis, attributed the record performance in Q2 and H1 2024 to the company’s strategic decision to position itself as a leading dry bulk operator with a pure-play Capesize fleet. The company says this move allowed the company to capitalize on the strong performance of the wider Capesize market, outpacing other dry bulk segments, catapulting the company ahead of the broader asset class. Seanergy has agreed to acquire, as previously announced, a modern Capesize vessel, enhancing its current fleet. The company expects to take delivery of a Japanese-built Capesize in Q3. After the latest additions, its fleet will comprise 19 high-quality Capesize vessels, up from 17 in early 2024. The Capesize market has been sailing smoothly since Q1 2024, according to Seanergy, marking its best performance in over a decade. This strong momentum continued into Q2, boosting Seanergy’s fleet to an average daily time charter equivalent (TCE) of $26,636. With a strategic hedging plan in place, Seanergy’s TCE was roughly 18% higher than the Baltic Capesize Index’s average of $22,600. “Seanergy is well positioned to continue performing strongly amidst the favorable Capesize market fundamentals, and we will remain focused on delivering high shareholder returns while opportunistically growing our fleet,” said Tsantanis. Seanergy Spin-Off Makes Strategic Investments United Maritime Corporation (Nasdaq: USEA), which was spun off from Seanergy two years ago, has also made strategic moves, capitalizing on opportunities across various diversified sectors. Following a recent swing to profitability in the second quarter, United Maritime has declared its seventh consecutive quarterly dividend of $0.075 per share. Additionally, the company is making a minority investment in a new offshore Energy Construction Vessel (ECV) project through a partnership with Norwegian counterparts, with expected completion in 2027. The ECV will serve both the oil and gas and renewable energy sectors, where demand is currently outpacing supply. United Maritime also partnered to charter-in an Aframax tanker, which is run by a reputable tanker pool operator, for as long as nine months. United Maritime has also secured $48.3 million year-to-date in financing deals, the proceeds of which will be directed toward refinancing multiple ship leases. Robust Vessel Demand Seanergy and United Maritime remain optimistic about the outlook for the Capesize sector, in which both report being advantageously positioned. Vessel demand remains robust amid a backdrop in which China's iron ore and coal imports are growing while a similar demand story unfolds in the Brazilian export market. Orderbook data suggests a slow-growing fleet size will persist, in response to which dry bulk demand is likely to outpace supply for the foreseeable future, according to the companies. Investors who are interested in diversifying their portfolios with exposure to the maritime industry with a leader in the Capesize space can learn more about Seanergy Maritime Holdings Corp. and United Maritime Corporation by visiting Seanergy’s website here and United’s website here. Featured photo courtesy of Seanergy. Contact Details Seanergy Investor Relations E-mail: ir@seanergy.gr United Investor Relations E-mail: ir@usea.gr Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

September 04, 2024 09:00 AM Eastern Daylight Time

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Mainz Biomed Seeks FDA Approval For Colorectal Cancer Test It Says Is Nearly Twice As Sensitive As Others – A Look At Pipeline And Milestones

Benzinga

By Anthony Termini, Benzinga In August 2020, popular actor Chadwick Boseman succumbed to colorectal cancer at the age of 43 after a four-year battle with colon cancer. The untimely death of the Black Panther star saw many fans overcome with grief but also brought attention to the danger posed by such cancers. Colorectal cancer is the second leading cause of cancer death in the United States, with more than 100,000 cases diagnosed so far in 2024. Mainz Biomed (NASDAQ: MYNZ), a German company whose U.S. offices are in Berkeley, California, believes the threat can be mitigated by technology and is working on a predictive test that may be more effective than solutions currently on the market. Benzinga recently sat down with the company’s CFO, Bill Caragol, to discuss the challenge and all the work the company is doing to help address it. The Available Options For Detecting Colorectal Cancer The standard of care for detecting colorectal cancer has since 1969 been the colonoscopy. The procedure is invasive and not very pleasant. In 2014, the fecal immunochemical test (FIT) received FDA approval. The test analyzes a person’s DNA to detect advanced adenomas, the pre-cancerous polyps that “may be the most valid…marker for present and future colorectal cancer risk,” according to research published by the National Library of Medicine. Blood-based tests are also available to detect colorectal cancer risk. However, some in the medical community are cautious about their use. According to David Lieberman, MD, chair of the American Gastroenterological Association’s Colorectal Cancer Workshop, “blood tests are neither as effective or cost-effective" as established colorectal cancer screening tests – something that Mainz’s Caragol testifies to, as well, stating that doctors continue to prescribe stool-based tests over blood tests because of the clinical differentiation since stool-based tests are better at detecting early-stage cancer, despite the “yucky factor.” He added,”Remember, [with] colorectal cancer – you detect late-stage, there’s a roughly 10% survival. When you catch it in early-stage, there’s 90% survival.” Mainz’s Breakthrough Device Leads To Next-Generation Screening Test Mainz has developed a molecular diagnostic solution to detect colon cancer risk. In July, Mainz submitted an application to the U.S. Food and Drug Administration (FDA) requesting Breakthrough Device Designation for a non-invasive colorectal cancer product that includes a portfolio of mRNA biomarkers. Studies conducted by Mainz revealed that its mRNA-powered test showed a sensitivity for detecting precancerous polyps that is double that of products currently on the market. In those studies, competitors’ tests “demonstrated efficacy of detecting advanced adenomas in the 40% range,” says Bill Caragol. Caragol added that readouts from the three clinical studies Mainz conducted between 2023 and 2024, “demonstrated consistent accuracy above 80%, a quantum leap...over the other stool-based tests.” Mainz says its flagship product, ColoAlert®, misses far fewer cases than its competitors’ tests. Mainz puts the number at up to 60% fewer cases. Its next-generation FIT test is an enhancement of ColoAlert and was submitted to the FDA in July for Breakthrough Device designation. The next-generation FIT test is complemented by a proprietary algorithm that uses artificial intelligence and machine learning to identify mRNA biomarkers in order to better detect the early warning signals of potential colorectal cancer. Mainz said the test is “a new gold standard for noninvasive detection of advanced adenomas.” The company is scheduled to conduct an FDA pre-market approval study in 2025 for its next-generation test. A focus of the study is to distribute the next-generation test kit through the currently existing network of FDA-approved national reference testing laboratories in the United States. This differs from other products currently on the market in that the companies that make those test kits also control the testing process. As Caragol describes it, “every test [is] manufactured by them, sent out by them, returned to them [for analysis], test results delivered.” As a result, says Caragol, Mainz will have “the only product that will fit into the largest distribution.” Milestones Mainz Is Focused On For The Year Ahead Mainz has a clear strategy for approaching the market. Caragol said that they realize that as a small company targeting a large market, they will have to strategically align themselves with larger companies. The company is looking to partner with a PCR provider as well as one of the national reference labs. PCR labs specialize in blood, urine and other molecular testing to detect pathogens, commonly used for diagnosing infections like COVID-19. National reference labs offer a wide range of high-accuracy diagnostic services, including PCR, serving as centralized hubs for specialized testing across various locations. Having these partnerships in place is necessary for Mainz to conduct its FDA pre-market approval study. Importantly, they will also be important allies if the company receives approval to sell the kits. They will be integral components of Mainz’s commercial go-to-market strategy. At that point, Mainz’s commercial roadmap will focus on creating partnerships and awareness within physician networks and health care professionals about the differentiating benefits of the ColoAlert mRNA powered test. Investment Drivers For Companies Like Mainz Biomed If the company can meet each of its milestones, then it could set a course for future growth. The U.S. market for colorectal screening “is over $30 billion a year,” according to Caragol. He notes that the market is double that worldwide. There are a number of companies competing domestically for colorectal screening, the most notable of which is Exact Sciences Corp. (NASDAQ: EXAS). Caragol says Exact has about a 10% share of U.S. sales. As such, there may be an opportunity for Mainz if its next-generation test receives FDA approval in the next few years. The company says that a successful launch could open the door to other products, including test kits for pancreatic and other gastrointestinal cancers – significantly expanding its addressable market. For more information about Mainz Biomed listen to the conversation Bill Caragol had with Benzinga’s Zunaid Suleman. Featured photo by Furiosa-L from Pixabay. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

September 03, 2024 08:35 AM Eastern Daylight Time

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Palatin Technologies: Utilizing The Melanocortin System As The Basis For Innovation In Drug Development – Targeting Inflammatory & Autoimmune Conditions, Obesity And Sexual Dysfunctions

Benzinga

By Kyle Anthony, Benzinga Palatin Technologies (AMEX: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, received the first FDA approval for a melanocortin agent, for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women, with its product, Vyleesi ® (bremelanotide injection) – and it has big plans for the treatment of erectile dysfunction (ED) in patients that do not respond to PDE5i (viagra ®, cialis ® ) monotherapy The melanocortin system is a group of hormones, receptors and other molecules in the body that regulate various physiological processes, including skin pigmentation, appetite, energy balance and inflammation. For Palatin Technologies, the melanocortin system has been a source of innovation. The firm leverages its knowledge of the melanocortin system to design therapeutics that directly engage one of the body’s natural pathways to resolve harmful inflammation, providing a novel approach that allows affected tissue time to heal. The Mission Of Palatin Technologies Founded in 1986 by Dr. Carl Spana and other scientists with the initial aim of developing proprietary technologies and drug candidates for large markets with unmet needs, including cardiovascular disease and cancer, the firm has undergone a series of changes over the years. In the early 2000s, Palatin began focusing on the melanocortin system, particularly developing drugs that target melanocortin receptors. The company’s mission is to leverage its unique insight and expertise in the industry and the melanocortin system to develop groundbreaking therapeutics for inflammatory and autoimmune diseases, focusing on ocular conditions, plus obesity and sexual dysfunctions. Maximizing The Capabilities Of The Melanocortin System The melanocortin system is mediated by a family of five related receptors that are essential to the body’s control of inflammation, immune response, metabolism, steroid hormone production and sexual function. As mentioned previously, Palatin Technologies’ current focus is on the design and development of receptor-selective melanocortin agonists for inflammation and autoimmune conditions, with an emphasis on ocular diseases, plus obesity and sexual dysfunctions. Palatin Technologies’ therapeutics work by activating endogenous melanocortin pathways to resolve damaging inflammation and allow affected tissues time to heal. Research has shown melanocortin agonists can prevent and reverse intestinal and ocular inflammation in animal models. Current ocular drugs can be limited by drawbacks such as inadequate efficacy, high discontinuation rates and delayed onset of action. These challenges result in a less-than-ideal treatment experience, causing frustration and driving the need for more effective solutions. Melanocortin receptors, which are found on the surface of various cells in the eye and within immune cells in ocular tissue, represent a promising target for melanocortin agonists to offer relief and healing for individuals suffering from ocular diseases. For inflammation and autoimmune diseases, current treatments – including steroids, immune modulators and biologics – largely work by broadly suppressing the immune response. However, these methods can weaken the body's overall immune function, leading to unwanted side effects and raising safety concerns. Melanocortin agonists offer the potential to resolve inflammation without these adverse effects and safety issues associated with immunosuppressants. Palatin Technologies: Success And Product Pipeline Though Vyleesi was Palatin Technologies' first commercial product, the company recently announced several program advancements: Patient dosing has started for the clinical study entitled: BMT-801: A Phase II, Randomized, Double-Blind, Placebo-Controlled, Clinical Study Investigating the Safety, Tolerability, and Effectiveness of the Co-Administration of Bremelanotide with Tirzepatide (GLP-1/GIP) for the Treatment of Obesity Topline Results Expected Q1 Calendar Year 2025 FDA Confirms Acceptability of Palatin’s Remaining Phase 3 Pivotal Clinical Trials for PL9643 in Dry Eye Disease (DED) MELODY-2 & MELODY-3 Phase 3 Clinical Trials Targeted To Start Later This Calendar Year Topline Results Expected Q4 Calendar Year 2025 Treating Eye Related Diseases As referenced previously, Palatin is exploring using melanocortin agonists for age-related eye diseases. As detailed in the company’s corporate presentation, diseases such as dry eye disease, glaucoma and retinopathies are sizable target markets. Dry eye disease (DED) or keratoconjunctivitis is a multifactorial disorder of the tears and ocular surface. Symptoms include dryness, irritation, redness, discharge and blurred vision. Inflammation plays a prominent role in the development and amplification of the signs and symptoms of DED. According to research compiled by the company, the global market size for DED is estimated to be worth $7.0 billion in 2024, growing to $12.3 billion by 2032. Earlier this year, Palatin announced the phase 3 clinical results for its PL9643 melanocortin agonist treatment of DED. Regarding the findings, Carl Spana, Ph.D., President and CEO of Palatin, stated, “We are pleased that PL9643 treatment demonstrated excellent safety and tolerability data, including superior efficacy results compared to vehicle across multiple sign and symptom endpoints.” PL9643 represents an opportunity to bring relief to dry eye disease sufferers. According to Palatin, while DED is one of the most common ocular disorders, affecting an estimated 38 million people in the U.S., only about 18 million are diagnosed, and less than 10% of those diagnosed are treated with a prescription product. This shows the significant unmet medical need for an effective treatment with an excellent safety and tolerability profile. There is a sizable market opportunity for the other previously mentioned eye diseases: Palatin’s research states that the 2030 global market estimate for glaucoma is $11.52 billion, and the 2027 global market estimate for retinopathies is $27 billion. Palatin has ongoing melanocortin receptor programs for each disease to explore treatment methods. Treating Autoimmune Diseases There is also a growing opportunity to treat the underlying inflammation in autoimmune diseases that physicians commonly treat with broad immunosuppressants that potentially increase the risk of complications. Palatin Technologies, with an ongoing phase 2 clinical trial, is exploring how its treatments can tackle ulcerative colitis (UC), which the company says could benefit nearly 1 million people in the U.S. who suffer from an autoimmune disease that manifests as chronic inflammation of the colon. Palatin’s research states that the global ulcerative colitis market was estimated to be worth $5.5 billion in 2021 and is projected to be worth $8 billion by 2026. Palatin’s oral MCR1 agonist (PL8177) was developed to resolve inflammation directly in the colon, avoiding broad immunosuppression and adverse effects with its potent, selective compound. Palatin reports that two phase 1 studies have produced promising results – the first demonstrated the significant safety and tolerability of PL8177, while the second highlighted the value of an oral, delayed-release polymer formulation that can achieve local release without systemic absorption. PL8177 has advanced and is now being investigated in a phase 2 clinical trial. Treating Obesity Obesity represents a rising worldwide public health concern. Obesity is associated with an increased risk of overall mortality and serious health conditions, including high blood pressure, high cholesterol, type 2 diabetes, coronary heart disease, stroke and certain cancers. Obesity is associated with increased healthcare resource use and high economic burden. Safe and effective obesity treatments therefore remain a critical unmet need. In the United States, about 42% of adults live with obesity, and one out of five teens between the ages of 12-19 live with obesity, according to data compiled by Palatin. “The growth of GLP-1 agonists to treat obesity has been incredible and highly effective in the short run, but data shows that 67% of patients discontinue use due to side effects and a plateau effect in the first year, said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. “This often results in a rebound effect with patients gaining back significant weight. Our research coupled with emerging clinical data indicates that combining an MCR4 agonist with incretin therapeutics like tirzepatide may result in synergistic effects on weight loss allowing for increased weight loss at lower and better-tolerated doses.” Sexual Dysfunction Product Expansion And Product Development Milestones The success of Vyleesi, which was sold to Cosette Pharmaceuticals in December 2023 for $12 million upfront and up to $159 million in sales milestones, has established a precedent for success in the sexual dysfunction category for Palatin Technologies. Presently, the firm is looking to build on this success and is exploring a product for the treatment of erectile dysfunction (ED) in patients that do not respond to PDE5i (viagra ®, cialis ® ) monotherapy. According to Palatin, over 30 million men in the U.S. suffer from ED, with approximately 35% of them being inadequately served by existing treatment options. Palatin believes that their MCR4 agonists can be a safe and effective treatment therapy for ED. Across Palatin’s product roadmap, several milestones are slated to occur in the latter half of 2024 or the first half of 2025. Regarding the second half of calendar year 2024, the company’s phase 2 obesity trial of an MCR4 agonist + GLP-1 will initiate enrollment (patient dosing has commenced), Melody-2 and Melody-3 phase 3 clinical trials for the treatment of DED will begin, and the phase 2 proof-of-concept interim data for PL8177 for ulcerative colitis is expected to readout. Regarding the first half of calendar year 2025, the company’s phase 2 obesity trial of an MCR4 agonist + GLP-1 topline results are expected, and the pharmacokinetics study for the clinical program with bremelanotide co-formulated with a PDE5i for the treatment of erectile dysfunction (ED) in patients that do not respond to PDE5i monotherapy will start. A Vision For The Future For Millions Of Patients Overall, Palatin Technologies is actively expanding its clinical programs and progressing toward potential new therapies for patients with limited or ineffective treatment options. Melanocortin pathway therapies represent a promising and versatile approach to treating various conditions, with ongoing research and development expanding their potential applications. Palatin Technologies is at the forefront of this treatment approach, potentially helping reshape the medical landscape. For more information about Palatin Technologies, visit its website. Featured photo by Louis Reed on Unsplash. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

August 29, 2024 08:45 AM Eastern Daylight Time

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Pasofino Gold: Unlocking Liberia’s Untapped Gold Potential

Benzinga

By James Blacker, Benzinga Liberia is rich in mineral resources. With gold, diamonds, and iron ore found in many parts of the country, the mining sector makes up a large part of its economy; revenues from iron ore accounted for almost half of Liberia’s earnings before 1990. Gold mining has historically been dominated by small-scale artisanal miners, but the last two decades have seen billions of dollars of investment pouring in from players such as ArcelorMittal (OTC:AMSYF), Liberty Gold (OTC:LGDTF) and Hummingbird Resources (OTC:HUMRF). These big players have paved the way for others like Pasofino Gold (OTC: EFRGF) to explore Liberia’s potential. The company sees Liberia as a strong candidate for gold mining due to its many unique characteristics, the extensive exploration performed by the company to date, their completed feasibility study and the positive economics resulting from that. Liberia, with a population of 5.3 million, stands as Africa's oldest modern republic. The government of Liberia has consistently shown a pro-mining stance, creating a favorable environment for mining activities. Since 2011, Liberia has been compliant with the Extractive Industries Transparency Initiative (EITI), becoming the first African country to adhere to its regulations. The country's mining laws are designed based on Australian mining regulations, providing stability and clarity for the industry. With a high level of Foreign Direct Investment (FDI) compared to GDP, Liberia stands as a potentially attractive investment destination in West Africa. With FDI surpassing $18 billion, Pasofino Gold considers Liberia an important gold exploration frontier. The Dugbe Gold Project The Dugbe Gold Project, which is owned by Pasofino, covers an area of 2,078 square kilometers (802 square miles) in southern Liberia, an area known for rich gold deposits. Bukon Jedeh is just one of 15 or more targets within the license. Only five of these targets have been drilled so far. Two of these became the Tuzon and Dugbe F deposits, which were initially discovered by Hummingbird in 2009 and 2011 respectively. Additionally, a number of opportunities have been identified to optimize the feasibility study, which was completed during the COVID-19 pandemic with challenges incurred during that time. Pasofino operates the project under a 25-year agreement with the government of Liberia, which includes a 3% royalty rate on gold production and a 25% income tax rate. The government holds a 10% interest in the project. Although less than 20% of the project has been explored so far, Pasofino Gold reports that the known discoveries are already promising. This includes the Dugbe F and Tuzon areas, which hold a combined Measured and Indicated Resource of approximately 3.3 million ounces of gold. Multiple drill-ready targets also display abundant gold mineralization at the surface, the company says. With such substantial resources, the Dugbe Gold Project is a key asset and holds great potential for future growth, Pasofino Gold argues, suggesting it may be on the verge of unlocking a significant gold resource in Liberia. The company has developed strong relationships with the people and community in the region, it says, and is excited about contributing to developing Liberia as a strong contender in the gold market. Featured photo by Shutterstock. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains advertising content. This content is for informational purposes only and not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

August 28, 2024 08:55 AM Eastern Daylight Time

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InMed Demonstrates Encouraging Data For Its Cannabinoid INM-089 In Treating Dry AMD, An Ocular Disease With Rising Patient Numbers As National Population Ages

Benzinga

By Meg Flippin, Benzinga When it comes to diseases of the eyes, age-related macular degeneration or AMD is a big one, afflicting 19.8 million people or 12.6% of Americans aged 40 and older. In adults 50+ it is the most common cause of severe loss of eyesight. People suffering from AMD, which affects central vision, lose the ability to see fine details. As the disease progresses, sufferers may not be able to see faces, read small print and even drive. What makes this incurable disease even worse is that in the early stages, there can often be no initial signs or symptoms. Left unchecked, patients may lose central field vision in the affected eye within 24 months of disease onset. While treatments are available, most focus on controlling the symptoms rather than addressing the underlying causes. Moreover, the treatments often rely on patients making changes to their lifestyles such as eating healthy and quitting smoking, which isn’t always easy to do. Cannabinoids May Be Part Of The Answer InMed Pharmaceuticals Inc. (NASDAQ: INM), a leader in cannabinoids and cannabinoid analogs pharmaceutical research, development, manufacturing and commercialization, may have a solution with INM-089, the company’s ocular program for AMD, which it launched in November. With scientific research continually pointing to the neuroprotective effects of cannabinoids, InMed set out to develop a cannabinoid analog that could treat ocular diseases such as AMD. For those with AMD, neuroprotection is essential to preserve the nerve cells in the eyes and potentially slow or reverse eye damage, which InMed says it is in the process of proving INM-089 can do. Studies of InMed’s INM-089 cannabinoid analog, which is a small molecule compound, demonstrated its ability to proactively protect the nerve cells in the back of the eye in the retinal area, exhibiting its therapeutic potential for AMD. Small molecules can cross the blood-brain barrier and are typically better suited for multiple drug delivery options because they can be efficiently absorbed, making INM-089 a promising drug candidate for pharmaceutical use, reports InMed. Studies Demonstrate INM-089’s Benefits The company has data to back up its assessment. Results from several in vitro and in vivo studies showed INM-089 provides neuroprotection of photoreceptors and improves photoreceptor function, enhances the integrity of the retinal pigment epithelium (RPE), preserves retinal function in the back of the eye and improves the thickness of the outer nuclear layer of the retina where photoreceptors are located. Neuroprotection in AMD remains an unmet medical need and a new treatment option addressing neuroprotection may help to eliminate or reduce the effects of the condition, InMed says. More recently, InMed found in a proof of concept study that INM-089 may be more effective in treating dry AMD than wet AMD and may be an “important” candidate for Geographic Atrophy (GA) which is common in more advanced cases of dry AMD, affecting the center of the macula. In vivo preclinical studies in AMD disease models demonstrated all of the previous benefits, as well as a reduction in extracellular autofluorescent deposits, a hallmark of dry AMD, the company reports. The latter wasn’t demonstrated in previous trials, leading InMed to believe INM-089 is ideally suited for dry AMD. Dry AMD Needs Immediate Attention Among forms of AMD, dry AMD is the most common, accounting for 85% to 90% of all cases. In 2023, the U.S. had the highest prevalence of dry AMD. With dry AMD, waste proteins and lipids begin to accumulate due to poor circulation and poor waste flushing in the eye. The advanced stage of dry AMD is referred to as Geographic Atrophy, with approximately five million patients globally suffering from it. The prevalence of GA is projected to continue to rise in the coming years, with an estimated 18.5 million cases globally by 2040 as the population ages. “We are very excited with the data from recent preclinical studies demonstrating both significant functional and pathological improvements from INM-089 in the AMD model,” Dr. Eric Hsu, SVP of preclinical research and development at InMed said. “While a few treatment options are currently available, their efficacy is limited and may be associated with several undesirable side effects. We see an opportunity for INM-089 to slow the progression and to fill a significant gap in the treatment of this chronic disease.” Taking It To The Next Level Given all the positive results of its studies, InMed said it recently engaged a Contract Development and Manufacturing Organization (CDMO) to assist in scale-up manufacturing process development of the active pharmaceutical ingredient. Meanwhile, the company is internally developing drug product formulation to support the next stages of development activities. What’s more, additional preclinical activities are ongoing to further understand the mechanism of action including receptor interactions and drug metabolism and pharmacokinetics studies, InMed said. All of these are being conducted with the goal of eventual commercialization of INM-089. The global population is aging, which means cases of AMD are poised to increase. That’s bad news given there is no cure, and the effects of this disease can be debilitating and life-altering. InMed doesn’t want that to be the case, and is betting its cannabinoid can play an important role in finding better treatments for AMD. With positive results from several studies under its belt, InMed is one step closer to bringing INM-089 to the millions of older adults who suffer from this disease. Featured photo by Jeremy Wong on Unsplash. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

August 28, 2024 08:40 AM Eastern Daylight Time

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45% of Canadians confess that rising prices impact their day-to-day lives

Money Canada

by Nicholas Sokic According to Statistics Canada data, 45% of Canadians reported that rising prices were greatly affecting their ability to meet day-to-day expenses in the first few months of 2024. Turns out the percentage of Canadians feeling the pinch rose in the last few years, from 33% of Canadians feeling the pinch in 2022 to 45% in 2024. “This extended period of financial strain can also negatively impact mental health," explain the report authors. For instance, when asked about financial-related stress in spring 2024, more than a third (35%) of Canadians described most days as "quite a bit" or "extremely stressful due to financial issues." Age cohort most impacted by rising prices? Canada’s rising prices did not affect all age cohorts equally. Nearly 6 in 10 of those in the lowest income quintile and about half of those in the second and third income quintiles report that rising prices greatly affected their ability to meet day-to-day expenses. When compared to those in the highest income quintile, only 27% reported experiencing financial stress. Stress of paying bills has mental health impact While paying bills was impacted, so was mental health. Almost half those in the lowest income quintile reported that on most days there were a bit or very stressed due to financial concerns. Compare this to only 25% of people in the highest income quintile who report stress over paying bills. Age isn't the only factor Other groups facing tougher financial situations include include younger people, households with children and disabled family members. More than half (55%) of Canadians between the ages of 25 to 44 reported that rising prices were greatly affecting their ability to meet day-to-day expenses. By comparison, only 28% of seniors reported having this difficulty. The figures were similar for individuals with a disability, with 57% reporting that rising prices were greatly affecting their ability to meet day-to-day expenses, compared with 43% otherwise. Financial difficulties and lower quality of life When you’re not worrying about the next bill or where your paycheck is going to come from, it makes perfect sense that you’d be more hopeful for the future. Of those who didn’t report having daily financial stress, 73% had a hopeful view of the future compared with 35% of those who found most days quite a bit or extremely stressful due to financial concerns. To put a fine point on the impact of finances on mental health, only 17% of Canadians who describe most days as stressful due to financial issues report a high satisfaction in life; compare this to 70% of Canadians who report that on most days they are not stressed about finances. Younger generation is most pessimistic about becoming a homeowner The biggest concern for many Canadians is the ongoing housing crisis. About 38% of Canadians report being "very concerned" with their ability to afford housing or rent because of rising home prices, compared with only 30% in the spring of 2022. Over half (56%) of those aged 15 to 34 reported being very concerned about housing affordability due to rising housing prices. Concern with housing affordability decreased with age, with only 19% of Canadians aged 65 years and older having the same concern. How to meet basic needs Despite the increase in the number of Canadians feeling the stress of increased costs, the decision to rely on external help hasn't changed much. When asked whether or not the rise in living costs would prompt a reliance on community organizations for food or meals, almost 1 in 4 Canadians (23%) confessed that this would be their go-to solution throughout 2024. Of these, 8% said is was a "very" likely option while 15% said it was somewhat likely. In 2022, only 1 in 5 Canadians (20%) reported relying on food banks and community groups for food and meals. Survey methodology The data was part of the Statistics Canada recent Canadian Social Survey with respondent input collected between April 19 to June 3, 2024. — with files from Romana King Contact Details Aaron Young +1 310-500-8744 aaron.young@wisepublishing.com Company Website https://money.ca/

August 28, 2024 07:00 AM Eastern Daylight Time

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Citi Remains Tactically Bullish on Uranium; Forecasts Price Rebound in 2024

MarketJar

On behalf of Generation Uranium Inc. Uranium has been a major investment theme over the past 18 months, with prices rising from below US$60/lb to over US$107/lb in February. Although the market has declined steadily since, leading many investors to question whether to hold or exit, Citi maintains a "tactically bullish" outlook for the market’s potential in 2024 and beyond. 1 Citi's latest research attributes the recent price stagnation to low trading volume and liquidity but expects a rebound as investor focus shifts. Citi forecasts uranium prices could rise to US$98/lb later this year, with an average of US$94/lb. By 2025, prices could reach US$110/lb, implying a potential upside of 36%. Citi points to increased uranium production as a factor in the recent price dip, with Kazakhstan's output expected to reach 59 million lbs this year. However, production growth is expected to slow sharply later in the decade. Meanwhile, inventories are projected to fall by 20 million lbs by 2030, putting uranium production back at the center of price determination. On the demand side, Citi notes the growing need for low-carbon energy and rising global power consumption. While no new nuclear plants are currently planned, Citi expects utilities to focus on extending plant life and restarting shuttered facilities, potentially boosting uranium demand, especially in the US. As the broader uranium market shows signs of a potential recovery, companies like Generation Uranium (TSXV:GEN) (OTCQB:GENRF) are well-positioned to capitalize on this trend through strategic projects and exploration initiatives. Generation Uranium is making significant strides with its Yath Uranium Project in Nunavut, Canada. 2 The company holds a 100% interest in this project, which is located in the prolific and under-explored Thelon Basin. Yath is strategically positioned along the trend of the Lac 50 uranium deposit, which contains 43 million lbs of uranium and is currently being developed by Latitude Uranium, a company recently acquired by ATHA Energy for $64.7 million in an all-share deal. 3 Historical exploration at Yath has consistently indicated uranium concentrations between 1% and 10% U3O8, underscoring its potential. In June, Generation Uranium acquired the Yellow Frog and Pink Toad Uranium Projects along the Angilak Trend in Nunavut, Canada. These acquisitions expand the Company's Yath Uranium Project by over 45%, bringing its total coverage to 123.45 km². Yath now extends northward, coming within 3 kilometers of Atha Energy Corp’s Angilak Project. Generation Uranium Partners With APEX Geoscience and ATHA Energy to Advance Yath Uranium Project In a further move to advance the Yath Project, Generation Uranium (TSXV:GEN) (OTCQB:GENRF) has partnered with APEX Geoscience. APEX will provide geological consulting services and assist in preparing and submitting exploration authorization applications for a planned diamond drilling campaign. This collaboration includes coordination with key regulatory bodies such as the Nunavut Planning Commission, Nunavut Impact Review Board, and Kivalliq Inuit Association to ensure compliance with all regulations. This partnership builds on historical data pointing to significant uranium potential at Yath, with past explorations and recent surveys by Kivalliq Energy affirming the high-grade uranium deposits. The collaboration with APEX Geoscience emphasizes Generation Uranium ’s commitment to utilizing expert insights and advanced technology to maximize the Yath Uranium Project’s potential, setting the stage for future development and regional economic growth. To accelerate exploration, Generation Uranium (TSXV:GEN) (OTCQB:GENRF) has launched an advanced airborne electromagnetic survey at the Yath Project, in partnership with ATHA Energy Corp. The survey is being conducted by Expert Geophysics Ltd., a leader in geophysical survey technology, using its cutting-edge Mobile MagnetoTellurics (MMT) system. This system, known for its precision, will employ the latest airborne AFMAG (Audio-frequency Magnetic) technology to identify electromagnetic (EM) anomalies across the 123.45 km² property. The survey will cover 890 line-kilometers with a 150-meter line spacing, gathering high-resolution magnetic and VLF data. The collaboration with ATHA Energy allows Generation Uranium to leverage economies of scale, reducing costs and speeding up the exploration process. CEO Anthony Zelen expressed confidence in the project, highlighting the strategic partnership and advanced technology as key factors in advancing Yath towards drilling. Click here for more information about Generation Uranium (TSXV:GEN) (OTCQB:GENRF). [1] https://www.marketindex.com.au/news/uranium-prices-will-rise-again-remain-tactically-bullish-citi [2] https://generationuranium.com/yath-project [3] https://generationuranium.com/news/b/guexploration Disclaimer 1) The author of the Article, or members of the author’s immediate household or family, do not own any securities of the companies set forth in this Article. The author determined which companies would be included in this article based on research and understanding of the sector. 2) The Article was issued on behalf of and sponsored by, Generation Uranium Inc. Market Jar Media Inc. was paid $1,500 for the production and publishing of this article by Generation Uranium Inc.’s Digital Marketing Agency of Record (Native Ads Inc.). Additional details relating to Market Jar Media Inc.’s engagement by Generation Uranium Inc.’s Digital Marketing Agency of Record (Native Ads Inc.) are set out in https://pressreach.com/disclaimer-gen. 3) Statements and opinions expressed are the opinions of the author and not Market Jar Media Inc., its directors or officers. The author is wholly responsible for the validity of the statements. The author was not paid by Market Jar Media Inc. for this Article. Market Jar Media Inc. was not paid by the author to publish or syndicate this Article. Market Jar has not independently verified or otherwise investigated all such information. None of Market Jar or any of their respective affiliates, guarantee the accuracy or completeness of any such information. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security. Market Jar Media Inc. requires contributing authors to disclose any shareholdings in, or economic relationships with, companies that they write about. Market Jar Media Inc. relies upon the authors to accurately provide this information and Market Jar Media Inc. has no means of verifying its accuracy. 4) The Article does not constitute investment advice. All investments carry risk and each reader is encouraged to consult with his or her individual financial professional. Any action a reader takes as a result of the information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Market Jar Media Inc.'s terms of use and full legal disclaimer as set forth here. This Article is not a solicitation for investment. Market Jar Media Inc. does not render general or specific investment advice and the information on pressreach.com should not be considered a recommendation to buy or sell any security. Market Jar Media Inc. does not endorse or recommend the business, products, services or securities of any company mentioned on pressreach.com. 5) Market Jar Media Inc. and its respective directors, officers and employees hold no shares for any company mentioned in the Article. 6) This document contains forward-looking information and forward-looking statements, within the meaning of applicable Canadian securities legislation, (collectively, “forward-looking statements”), which reflect management's expectations regarding Generation Uranium Inc.’s future growth, future business plans and opportunities, expected activities, and other statements about future events, results or performance. 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These forward-looking statements include, among other things, statements relating to: (a) revenue generating potential with respect to Generation Uranium Inc.’s industry; (b) market opportunity; (c) Generation Uranium Inc.’s business plans and strategies; (d) services that Generation Uranium Inc. intends to offer; (e) Generation Uranium Inc.’s milestone projections and targets; (f) Generation Uranium Inc.’s expectations regarding receipt of approval for regulatory applications; (g) Generation Uranium Inc.’s intentions to expand into other jurisdictions including the timeline expectations relating to those expansion plans; and (h) Generation Uranium Inc.’s expectations with regarding its ability to deliver shareholder value. Forward-looking statements are not a guarantee of future performance and are based upon a number of estimates and assumptions of management in light of management’s experience and perception of trends, current conditions and expected developments, as well as other factors that management believes to be relevant and reasonable in the circumstances, as of the date of this document including, without limitation, assumptions about: (a) the ability to raise any necessary additional capital on reasonable terms to execute Generation Uranium Inc.’s business plan; (b) that general business and economic conditions will not change in a material adverse manner; (c) Generation Uranium Inc.’s ability to procure equipment and operating supplies in sufficient quantities and on a timely basis; (d) Generation Uranium Inc.’s ability to enter into contractual arrangements with additional parties; (e) the accuracy of budgeted costs and expenditures; (f) Generation Uranium Inc.’s ability to attract and retain skilled personnel; (g) political and regulatory stability; (h) the receipt of governmental, regulatory and third-party approvals, licenses and permits on favorable terms; (i) changes in applicable legislation; (j) stability in financial and capital markets; and (k) expectations regarding the level of disruption to as a result of CV-19. Such forward-looking information involves a variety of known and unknown risks, uncertainties and other factors which may cause the actual plans, intentions, activities, results, performance or achievements of Generation Uranium Inc. to be materially different from any future plans, intentions, activities, results, performance or achievements expressed or implied by such forward-looking statements. Such risks include, without limitation: (a) Generation Uranium Inc.’s operations could be adversely affected by possible future government legislation, policies and controls or by changes in applicable laws and regulations; (b) public health crises such as CV-19 may adversely impact Generation Uranium Inc.’s business; (c) the volatility of global capital markets; (d) political instability and changes to the regulations governing Generation Uranium Inc.’s business operations (e) Generation Uranium Inc. may be unable to implement its growth strategy; and (f) increased competition. Except as required by law, Generation Uranium Inc. undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future event or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. Neither does Generation Uranium Inc. nor any of its representatives make any representation or warranty, express or implied, as to the accuracy, sufficiency or completeness of the information in this document. Neither Generation Uranium Inc. nor any of its representatives shall have any liability whatsoever, under contract, tort, trust or otherwise, to you or any person resulting from the use of the information in this document by you or any of your representatives or for omissions from the information in this document. 7) Any graphs, tables or other information demonstrating the historical performance or current or historical attributes of Generation Uranium Inc. or any other entity contained in this document are intended only to illustrate historical performance or current or historical attributes of Generation Uranium Inc. or such entities and are not necessarily indicative of future performance of Generation Uranium Inc. or such entities. 8) The technical information contained in articles and videos produced for this campaign has been reviewed and approved by Mr. Derrick Strickland, P. Geo, (L5569) at Generation Uranium as the Qualified Person for the Company as defined in National Instrument 43-101. 9) Investing is risky. The information provided in this article should not be considered as a substitute for professional financial consultation. Users should be aware that investing in any form carries inherent risks, and as such, there is a possibility of losing some or all of their investment. The value of investments can fluctuate significantly within a short period, and investors must understand that past performance is not indicative of future results. Additionally, users should exercise caution as transactions involving investments may be irreversible, even in cases of fraud or accidental actions. It is crucial to acknowledge that rapidly evolving laws and technical issues can have adverse effects on the usability, transferability, exchangeability, and value of investments. Furthermore, users must be cognizant of potential security risks associated with their investment activities. Individuals are strongly encouraged to conduct thorough research, seek professional advice, and carefully evaluate their risk tolerance before engaging in any investment endeavors. Market Jar Media Inc. is neither an investment adviser nor a broker-dealer. The information presented on the website is provided for informative purposes only and is not to be treated as a recommendation to make any specific investment. No such information on PressReach.com constitutes advice or a recommendation. Contact Details James Young +1 800-340-9767 campaigns@pressreach.com Company Website https://pressreach.com

August 27, 2024 09:24 AM Eastern Daylight Time

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The Potential Of Ketamir-2: A Safer Treatment For Mental Health Disorders And Neuropathic Pain, IND Filing Expected By Year-End

Benzinga

By Meg Flippin, Benzinga Treating mental health is constantly evolving, bringing new therapies and hope to people battling depression, treatment-resistant depression (TRD), post-traumatic stress disorder (PTSD) and other neuropsychiatric conditions. Not all therapies work for everyone, but sometimes an exciting treatment emerges. Ketamine, originally developed as an anesthetic, falls into that category. In recent years, it has been repurposed as a rapid-acting antidepressant, particularly for patients who have not responded to conventional treatments. While often effective, ketamine’s widespread use has been limited by its side effects and low oral bioavailability. Traditional ketamine requires intravenous or intranasal administration, which can be inconvenient and impractical for at-home treatment. Additionally, ketamine’s interaction with multiple receptor sites in the brain can lead to unwanted side effects such as dissociation, hallucinations and, in some cases, psychotic symptoms. Tweaking Ketamine But that doesn’t mean ketamine has to be written off as a new treatment for mental health. It just needs to be tweaked. That’s where MIRA Pharmaceuticals (NASDAQ: MIRA) and Ketamir-2 come in. A pre-clinical-stage pharmaceutical company, MIRA is refining this treatment with its oral ketamine analog, Ketamir-2. MIRA Pharmaceuticals says Ketamir-2 is a groundbreaking compound that has the potential to revolutionize the way mental health disorders and neuropathic pain are treated, offering a safer and more effective alternative to traditional therapies. The company is on track to file an Investigational New Drug (IND) application by the end of the year, marking what it says is a significant milestone in bringing Ketamir-2 closer to clinical trials. Ketamir-2 is designed to overcome the challenges of existing ketamine treatments by creating an agent that is more targeted. Ketamir-2 selectively inhibits the NMDA receptor at the PCP-binding site with 30 to 50 times lower affinity than traditional ketamine. This selective inhibition can reduce the risk of dissociation and hallucinations, providing a cleaner, safer therapeutic experience for patients. Preclinical studies have so far found that Ketamir-2 offers a superior safety profile compared to traditional ketamine. MIRA Pharmaceuticals said one of the most significant findings is that Ketamir-2 does not induce hyper-locomotor activity – a behavior associated with psychotic symptoms – making it a potentially safer option for patients. Better Oral Absorption Could Be Game-changing Another discovery MIRA Pharmaceuticals reports, is Ketamir-2’s non-substrate status for P-glycoprotein (P-gp), a membrane protein that typically limits drug entry into the brain. This means that Ketamir-2 can more effectively cross the blood-brain barrier, leading to better oral absorption and higher efficacy at lower doses. This feature is particularly important for patients seeking convenient, at-home treatment options. On top of all that, MIRA Pharmaceuticals says Ketamir-2’s principal metabolite, Nor-Ketamir, boasts nearly 100% oral bioavailability and sustained plasma residence. This means that once Ketamir-2 is administered orally, it is efficiently metabolized into Nor-Ketamir, which remains in the bloodstream longer, providing extended therapeutic effects. The development of Ketamir-2 Pamoate, a new salt form, further enhances these benefits by ensuring higher plasma and brain levels with a longer half-life, reports the company. Treating Chronic Pain Too Beyond depression and mental health issues, MIRA Pharmaceuticals said studies are ongoing to assess Ketamir-2’s effectiveness in treating neuropathic pain, a chronic and debilitating condition that has an estimated prevalence of 6.9% to 10% worldwide. The dual potential of Ketamir-2 to address both mental health disorders and neuropathic pain could represent a significant advancement in patient care, offering a versatile and effective treatment option. The potential of Ketamir-2 and Nor-Ketamir to offer effective, at-home treatment options for mental health disorders and neuropathic pain could prove to be a game-changer. The convenience of oral administration, combined with the drug’s safety and efficacy, could significantly improve patient adherence to treatment and overall outcomes. Further, the company says toxicology studies have validated Ketamir-2’s safety profile, with no observed toxicity at very high doses in animal models. Ketamine holds a lot of promise in treating mental health but the side effects are limiting adoption. Ketamir-2 could change that by addressing the limitations of traditional ketamine and offering a safer, more effective alternative. If the preclinical trials are any indication, Ketamir-2 could provide hope for many sufferers. For more information about MIRA Pharmaceuticals and its novel compounds, visit MIRA Pharmaceuticals. Featured photo by nikko macaspac on Unsplash Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

August 27, 2024 08:50 AM Eastern Daylight Time

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Theriva Biologics Receives Rare Pediatric Drug Designation From FDA For Treatment Of Retinoblastoma

Benzinga

By Kyle Anthony, Benzinga The growing prevalence of cancer is not limited to adults; it is also afflicting children. An estimated 15,780 children between birth and 19 years of age are diagnosed with cancer each year in the U.S., according to the American Childhood Cancer Organization. Approximately 1 in 285 children in the U.S. will be diagnosed with cancer before their 20th birthday. Globally, there are more than 300,000 children diagnosed with cancer each year, and the rate of childhood cancer is slowly rising; cancer cases increased to 177 per million in 2019 from 165 per million in 2003. Recently, Theriva Biologics (AMEX: TOVX), the clinical-stage immuno-oncology company developing therapies for difficult-to-treat cancers, was granted Rare Pediatric Drug Designation (RPDD) by the U.S. Food and Drug Administration (FDA) for VCN-01 for the treatment of retinoblastoma; the most common type of eye cancer in children. Retinoblastoma Presents Significant Treatment Challenges Retinoblastoma is a tumor that originates in the retina and accounts for approximately 2% of all childhood cancers. Some 200 to 300 children are diagnosed each year in the U.S., and the cancer is most common among infants and young children. The average age of a child when diagnosed is two years of age. Approximately three out of four children with retinoblastoma have a tumor in only one eye (known as unilateral retinoblastoma). When both eyes are affected it is known as bilateral retinoblastoma. Although the chances of developing retinoblastoma are statistically low, the challenge of preserving life while preventing the loss of an eye, blindness, and other severe consequences that diminish both lifespan and quality of life remains significant. Furthermore, in low-resource countries, children with retinoblastoma face a higher risk of losing their eyes and succumbing to metastatic disease. Recently, market research and industry consulting firm Spherical Insights assessed the global retinoblastoma treatment market size to be $2.5 billion in 2023; and it is expected to grow to $3.8 billion by 2033. Rare Pediatric Drug Designation For VCN-01 As the name suggests, the Rare Pediatric Drug Designation is a special status given to drugs explicitly developed for treating rare diseases that affect children. This designation is part of a broader effort to encourage the development of medications for conditions not commonly addressed due to the small number of patients, particularly in the pediatric population. For Theriva Biologics, this designation comes with a key incentive: if a Biologics License Application for VCN-01 for the treatment of retinoblastoma is approved by the FDA, Theriva says it may be eligible to receive a Priority Review Voucher (PRV) that can be redeemed to receive a priority review for any subsequent marketing application or may be transferred or sold. PRVs have previously been sold by different companies for around $100M. “The FDA’s decision to grant rare pediatric drug designation to VCN-01 highlights the urgent need for new treatment options for pediatric patients with retinoblastoma. We are encouraged by this important step forward and, in parallel, continue to work closely with leading physicians and regulatory agencies to refine our clinical strategy for VCN-01 as an adjunct to chemotherapy in pediatric patients with advanced retinoblastoma,” said Steven A. Shallcross, CEO of Theriva Biologics. “Most recently, results from the investigator-sponsored Phase 1 trial evaluating the safety and activity of intravitreal VCN-01 in pediatric patients with refractory retinoblastoma were determined to be positive by the study Monitoring Committee. Data from this study will further inform our clinical development pathway in this area of high unmet need,” he said. With VCN-01 receiving RPDD from the U.S. FDA, this milestone speaks to the drug's efficacy and long-run potential. As such, the social benefit that Theriva Biologics provides could continue to grow and have increased industry resonance. Featured photo by Ani Kolleshi on Unsplash. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

August 26, 2024 08:45 AM Eastern Daylight Time

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45% of Canadians confess that rising prices impact their day-to-day lives

Citi Remains Tactically Bullish on Uranium; Forecasts Price Rebound in 2024

The Potential Of Ketamir-2: A Safer Treatment For Mental Health Disorders And Neuropathic Pain, IND Filing Expected By Year-End

Theriva Biologics Receives Rare Pediatric Drug Designation From FDA For Treatment Of Retinoblastoma