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With Fresh Funding and Strong Phase 3 Data, PolyPid Advances Towards FDA Approval

Global Markets News

PolyPid Ltd. (NASDAQ: PYPD) * announced Tuesday that it has secured $26.7 million through warrant exercises following its successful SHIELD II Phase 3 trial results. This funding milestone extends the company’s runway beyond the anticipated FDA approval of its breakthrough surgical infection prevention technology, D-PLEX₁₀₀. For savvy biotech investors seeking undervalued opportunities with near-term catalysts, PolyPid presents a compelling case study in market inefficiency and potential outsized returns. A David Taking On a $10 Billion Goliath Surgical site infections (SSIs) represent a massive burden on healthcare systems, costing hospitals tens of thousands of dollars per incident while significantly increasing patient mortality. The $10 billion SSI prevention market has long awaited innovation beyond traditional antibiotic approaches. Enter PolyPid’s proprietary PLEX (Polymer-Lipid Encapsulation matriX) platform, which delivers targeted antibiotics directly at surgical sites for a full 30 days—dramatically longer than conventional methods that typically provide only hours of protection. “D-PLEX₁₀₀ demonstrated a statistically significant reduction in surgical site infections and successfully met the study’s primary endpoint and all key secondary endpoints,” the company stated in its announcement of the Phase 3 SHIELD II trial results. Most impressively, in patients with large surgical incisions, earlier SHIELD I data showed a remarkable 54% reduction (p=0.0032) in the composite endpoint of infections, reinterventions, and mortality compared to standard of care alone. The more recent SHIELD II trial demonstrated an even more stunning 58% reduction in surgical site infections, dropping infection rates from 9.5% with standard care to just 3.8% when D-PLEX100 was added. Why This $36M Company Could Soon Command a Valuation in the Hundreds of Millions Despite delivering transformative clinical results, PolyPid currently trades around $3.53 per share (as of June 18, 2025), representing a market cap of approximately $36 million – a significant discount to comparable companies in the surgical and pain management sectors, many of which command valuations in the hundreds of millions to over $1 billion. This valuation disconnect creates a potential opportunity for investors ahead of multiple catalysts: 1. NDA Submission in Early 2026: The company expects to file its New Drug Application in early 2026, leveraging Fast Track and Breakthrough Therapy designations already granted by the FDA. 2. Medicare’s New Technology Add-On Payment Eligibility: D-PLEX₁₀₀ qualifies for this program, potentially providing up to 75% reimbursement during early commercialization years. 3. U.S. Partnership Discussions: Management noted during a recent call that there has been “a change in partnering interest following December’s interim analysis,” with large pharmaceutical and medical device companies representing logical partners. 4. Substantial Market Opportunity: With 12 million eligible surgeries annually in the U.S. alone and another 8 million in Europe, D-PLEX₁₀₀’s market potential is substantial. 5. European Partnership Already Secured: PolyPid has secured a European commercialization partnership with Advanz Pharma worth up to $115 million plus double-digit royalties. The newly secured $26.7 million adds to PolyPid’s existing capital resources. With this additional funding, the company has stated that its runway would be extended beyond anticipated FDA approval of D-PLEX₁₀₀. Beyond D-PLEX₁₀₀: Platform Technology Offers Additional Growth Potential While D-PLEX₁₀₀ drives immediate value creation, PolyPid’s broader PLEX platform provides significant growth opportunities beyond surgical infections. Their OncoPLEX program applies identical technology principles to deliver cancer therapeutics directly to tumor sites, potentially revolutionizing solid tumor treatment approaches. A recent collaboration with ImmunoGenesis validates the platform’s broader applications beyond surgical infections. According to recent analyst reports, Wall Street remains bullish on PolyPid. H.C. Wainwright recently raised their price target to $13 (from $11), while analysts from JMP Securities and Craig-Hallum have maintained Buy ratings. On June 5, 2025, Roth MKM initiated coverage with a Buy rating. The consensus among Wall Street professionals points to price targets ranging from $10-13, suggesting significant upside potential from current levels. The Bottom Line For investors seeking opportunities with clear catalysts, PolyPid represents a compelling combination of transformative clinical results, definitive regulatory pathway, and strong Wall Street support. With clinical risk substantially reduced following successful Phase 3 results and a regulatory submission timeline now established, the focus shifts to commercial execution and partnership value creation—potentially setting the stage for significant share price appreciation as these milestones materialize. The company’s notable discount to peers, extended cash runway, and multiple near-term value drivers make it an intriguing opportunity for biotech investors looking for undervalued assets with clear paths to value creation. Recent News Highlights from PolyPid PolyPid Secures $26.7 Million Through Warrant Exercise Following Successful SHIELD II Phase 3 Trial Results PolyPid Announces Positive Topline Results from Phase 3 SHIELD II Trial: D-PLEX₁₀₀ Demonstrated Significant Reduction in Surgical Site Infections and Successfully Met Primary and All Key Secondary Endpoints This article is syndicated from The Finance Herald. * Paid Advertisement Disclaimer & Disclosure: This article was Published by Wall Street Wire™. Wall Street Wire™ is owned and operated by Arx Advisory Ltd (the “Operator”). The Operator receives an ongoing monthly subscription fee of $5,000 cash via bank transfer (since May 1st, 2025 which is ongoing as of the date of publication) from PolyPid Ltd (PYPD) (IL0011326795) to produce and distribute this content and additional promotional content and news distributions on various media and social channels. The operator receives additional cash fees for non promotional data and consulting subscriptions from PolyPid. This content is not financial or investment advice, and the authors are not licensed brokers, dealers or advisors. Please refer to our full disclosure and disclaimer here: https://redditwire.com/terms. Contact Details Wall Street Wire media.globalmarkets@gmail.com

June 18, 2025 11:22 AM Eastern Daylight Time

BiomX Stock Could Soar 3000% As This $10M Biotech Cracks The 'Superbug' Code, Wall Street Says

Global Markets News

BiomX Inc. (NYSE: PHGE)* has achieved what Big Pharma couldn't accomplish in over 20 years — successful clinical trials using viruses to treat life-threatening infections that no longer respond to antibiotics. The $10 million biotech has reported positive Phase 2 results in diabetic foot bone infections, a condition so challenging that no new drugs have been approved for it in two decades. Meanwhile, their cystic fibrosis program showed 14% of patients completely cleared chronic lung infections after just 10 days of treatment. Approximately 160,000 lower limb amputations occur annually in diabetic patients in the U.S., with 85% caused by diabetic foot infections or diabetic foot osteomyelitis — creating an $8 billion annual healthcare burden according to company data. Current treatments rely on antibiotics that increasingly fail due to resistance, often leaving amputation as the only option. Clinical Breakthroughs Across Two Major Programs BiomX's March 2025 Phase 2 results in diabetic foot osteomyelitis from 41 patients delivered notable outcomes. The company achieved statistically significant percent area reduction of ulcer size, with p-values of 0.046 at week 12 and 0.052 at week 13. The treatment showed separation from placebo starting at week 7, with differences greater than 40% by week 10. BiomX also demonstrated statistically significant improvements in ulcer depth and reducing ulcer area expansion, while BX211 was safe and well-tolerated throughout the study. The company's cystic fibrosis program has been equally impressive. In their Phase 1b/2a study, 14.3% of patients converted to sputum culture negative for P. aeruginosa after 10 days of treatment, compared to 0% in the placebo group. One patient had been infected for 35 years before achieving complete clearance. The FDA has granted this program both Fast Track designation and Orphan Drug Designation, potentially accelerating the approval pathway. BiomX's approach uses bacteriophages — viruses that naturally target and kill specific bacteria — instead of traditional antibiotics that bacteria can develop resistance against. The company has overseen more than 50 compassionate use cases with no significant side effects to date. Military Validation and Wall Street's Bullish Take The U.S. Defense Health Agency has provided $40 million in non-dilutive funding to BiomX's diabetic foot program, representing significant validation of the technology. "They're seeing soldiers coming out of the Ukraine war with extremely antibiotic-resistant infections," CEO Jonathan Solomon said during the company's May 2025 earnings call. Despite the clinical progress and military backing, BiomX trades at approximately $10 million market cap — a disconnect0 that has caught Wall Street's attention. H.C. Wainwright maintains a Buy rating with a $15 price target, representing potential upside of over 3000% from recent levels around $0.4 Laidlaw & Company rates the stock Buy with a $16 price target, suggesting almost 4000% upside potential. Laidlaw analyst Yale Jen called the recent data "an absolutely positive surprise" and characterized BX211 as "a high value and clinically de-risked asset." The analysts' optimism stems from the clinical validation across both programs, massive addressable markets, and limited competition in the phage therapy space. Major Catalysts on the Horizon BiomX estimates addressable markets exceeding $2.5 billion globally for their diabetic foot program and $1.6 billion for cystic fibrosis based on patient populations and potential pricing benchmarks. The company expects to have sufficient funding through Q1 2026, aligning with anticipated BX004 Phase 2b results in cystic fibrosis. Key upcoming catalysts include the Phase 2b readout for their cystic fibrosis program expected in Q1 2026, ongoing Phase 2/3 trial discussions with the FDA for their diabetic foot program, and potential regulatory meetings in the second half of 2025. The company is also exploring partnership opportunities as the phage therapy space attracts increasing attention from large pharmaceutical companies. With validated clinical data, military funding, and Wall Street price targets suggesting potential returns exceeding 3000%, BiomX could offer investors exposure to phage therapy as a potential new approach to treating antibiotic-resistant infections. As the global antibiotic resistance crisis intensifies, the company's nature-based approach to killing bacteria positions it at an interesting inflection point in infectious disease treatment. BiomX shares were trading at ~$0.4 at last check Recent News Highlights from BiomX BiomX Reports First Quarter 2025 Financial Results and Provides Business and Program Updates BiomX Announces Positive Topline Results from Phase 2 Trial Evaluating BX211 for the Treatment of Diabetic Foot Osteomyelitis (DFO) * Legal Disclaimer & Disclosure: Nothing in this report constitutes financial or investment advice, nor does it represent an offer to buy or sell securities. This report is published by Wall Street Wire™. The operators of Wall Street Wire, arx advisory, are not registered brokers, dealers, or investment advisers. This report contains and is a form of paid promotional content or advertisement for BiomX Inc and was produced as part of their paid subscription to Wall Street Wire. This report has not been reviewed or approved by BiomX Inc prior to publication. The operators of wall street wire have received or are expected to receive a monthly recurring fee of five thousand united states dollars via wire transfer from BiomX as part of an ongoing agreement starting June 1st, 2025 in return for social media distribution and promotional coverage services, and receive additional compensation for non promotional unrelated data and advisory services on top of that. They do not hold any shares in BiomX. Please review the full disclaimers and compensation disclosures here for further details: redditwire.com/terms. We are not responsible for the price targets mentioned in this article nor do we endorse them, they are quoted based on publicly available news reports believed to be reliable and additional or price targets may exist that may not have been quoted. Readers are advised to refer to the full reports mentioned on various systems and the disclaimers/disclosures they may be subject to. Contact Details News Coverage ronald@futuremarketsresearch.com

June 16, 2025 07:04 PM Eastern Daylight Time

Sheon Karol Joins West Lane Partners as Senior Advisor

West Lane Partners

West Lane Partners, a private equity firm focused on special situations in middle market companies spanning healthcare, tech, financial services and industrials, is pleased to announce that Sheon Karol, a nationally recognized investment banker and restructuring advisor, has joined the firm as a Senior Advisor. Mr. Karol brings over three decades of experience in investment banking, restructuring, and senior corporate leadership, with deep expertise in complex M&A, capital raises, and operational turnarounds. Skilled in de-risking situations, he brings a flexible yet disciplined approach that favors iterative decision-making over rigid or binary choices. His ability to surface a range of strategic options, often under pressure, has made him a trusted advisor to owners navigating both opportunity and uncertainty. His contributions to the field have earned national recognition, including the “Boutique Investment Banker of the Year” award from the Atlas Awards. “Sheon and I have been in the trenches together on complex deals. He’s masterful at aligning stakeholders, cutting through noise, and adapting in real time to keep transactions on course. Where others see roadblocks, he sees possibility—and responds with clarity and flexibility,” said Deryck Palmer, Founder and Managing Partner at West Lane Partners. “His dynamic approach, experience, and deep market insight into the industries on which we’re focused, and an instinct for what owners value most, makes him an exceptional addition to our firm.” “I think of the middle market as the river less fished” said Mr. Karol. “Middle market companies are often overlooked, undercapitalized, and underserved by institutional talent. At West Lane Partners, our focus on investments between $25 million and $75 million is about more than deal size—it’s about bringing high-caliber insight to businesses at pivotal moments and tailoring strategic options to match the evolving goals of owners and the realities of the market. The result is not just getting deals done, but generating long-term value others might miss.” Mr. Palmer added, “I’ve always been impressed by Sheon’s expertise, creativity, positivity and determination to get the best for his clients. These qualities enable him to inexorably bring difficult situations to their best possible conclusion and there are few who bring such capabilities to the middle market.” About Sheon Karol Mr. Karol has advised on high-stakes transactions across a myriad of industries in the middle market, including manufacturing, biotech, pharma, for-profit education, medical research, agriculture, consumer goods, food & grocery, sports, and technology. Mr. Karol has successfully executed a wide range of strategic transactions, including M&A advisory, capital raises, and restructurings, for both healthy and distressed businesses and their stakeholders. He has also served in executive capacities, including as Chief Restructuring Officer of a $1 billion company, for which he renegotiated the company's debt and avoided a bankruptcy filing. Many of Mr. Karol’s transactions, including Violin Memory and Peekay Boutiques, have won awards. He served as SVP of Winn-Dixie and managed the company's sale of assets in excess of $200 million and the disposition of 326 stores (in a 90-day period); guided the auction and sale of Farmland’s nitrogen fertilizer business that exceeded the “stalking horse” bid by $25 million; advised the CRO in the sale of the Texas Rangers baseball team; and advised foreign buyers in their U.S. expansion. Trustee positions include the Violin Memory and Lily Robotics Trusts. A middle market M&A thought leader, he writes and lectures widely, including on entrepreneurship, auction theory, sale processes, the middle market and foreign buyers. He holds FINRA SIE, Series 63 and Series 79 certifications. Mr. Karol received a J.D. from Yale Law School and a B.A. from Yeshiva College. About West Lane Partners West Lane Partners is a private equity firm whose senior leadership has over 150 years of collective restructuring and private equity experience working with underperforming, stressed and distressed companies across a range of industries in both large cap and middle market companies. In addition to providing capital, the firm combines decades of restructuring, private equity, legal and financial expertise to collaborate with management in developing and executing bespoke solutions that deliver mutually beneficial outcomes. Contact Details Curtis Johnson, Investor Relations +1 973-404-0999 cjohnson@westlanepartners.com Meir Kahtan Public Relations, LLC Meir Kahtan +1 917-864-0800 mkahtan@rcn.com Company Website https://www.westlanepartners.com

June 11, 2025 10:00 AM Eastern Daylight Time

Inspira Technologies Receives $2 Price Target and Buy Rating: Everything You Need to Know

Global Markets News

Litchfield Hills Research has initiated coverage of Inspira Technologies OXY B.H.N. Ltd. (NASDAQ: IINN)* with a Buy rating and a $2 price target, representing potential upside of over 225% from current trading levels of around $0.61 per share. This bullish outlook comes as the medical technology company continues to critical care technology addressing what the analyst describes as "a medical need without good options." The analyst notes that mechanical ventilators are "WWII technology in desperate need of an upgrade" with reports showing that 30% to 50% of ICU patients don't survive. Unlike mechanical ventilation, Inspira's ART500 technology would enable patients to remain awake during treatment while stabilizing oxygen levels without intubation and coma. What distinguishes Inspira from typical early-stage medical device companies is its proven regulatory execution and early commercial success. The company's first generation technology, the INSPIRA ART100 system, received FDA clearance in May 2024 and is already deployed in leading U.S. hospitals. The excitement around this technology reached a new high in April 2025 when the first successful patient treatment was completed at Westchester Medical Center. The commercial momentum seems to be accelerating. Inspira announced it received payment in the "low hundreds of thousands of dollars" from its U.S. distributor for delivered systems, marking the company's first revenues. CEO Dagi Ben-Noon called this "a transformative milestone for Inspira as we establish our presence in the U.S. medical landscape." The company has now initiated global commercial rollout discussions and expects additional deliveries in the second half of 2025. Central to Inspira's technology platform is the AI-powered HYLA blood sensor, which recently achieved 96% accuracy in clinical studies at Sheba Medical Center, one of the world's top hospitals. The system provides continuous monitoring without requiring blood draws, targeting the blood gas analyzer market projected to reach $5.7 billion by 2030. The analyst identifies massive market opportunities, with the global mechanical ventilators market expected to reach $20.69 billion by 2034. Inspira's flagship INSPIRA ART500 system in development aims to disrupt this market by providing respiratory support through direct blood oxygenation rather than forcing air into damaged lungs. Inspira has established strong intellectual property protection with multiple U.S. patents and novel patent claims protecting its core technologies. The company is executing a strategic approach of securing FDA clearance for individual components before integrating them into comprehensive systems. When comparing Inspira to similar medical device companies, the analyst found the stock trades at significant discounts despite having FDA-cleared technology already treating patients. The $2 price target reflects confidence in the company's ability to capitalize on its early commercial success and expand into the massive mechanical ventilation market. The analyst concludes that Inspira may represents a unique opportunity, combining proven FDA-cleared technology with substantial market opportunity and attractive valuation metrics in the high-growth medical device sector. Recent News from Inspira: Inspira Technologies Initiates Global Commercial Rollout of FDA-Cleared ART100 System INSPIRA ART100 System Approved by Israel's Largest Healthcare Provider for Use in Organ Transplant Patients Inspira Achieves above 99% Gas Exchange Efficiency in VORTX™ Technology In-Vivo Animal Testing * Legal Disclaimer & Disclosure: Nothing in this article constitutes financial or investment advice, nor does it represent an offer to buy or sell securities. This report is published by the Wall Street Wire platform & media network. The operators of Wall Street Wire are not registered brokers, dealers, or investment advisers. This article contains paid promotional content related to Inspira Technologies and was produced as part of their paid subscription to Wall Street Wire, which includes a monthly fee of five thousand US dollars paid in cash via bank transfer in return for promotional content and distribution services. The operators also receive additional fees for non promotional advisory and data services. Inspira Technologies did not necessarily review or approve this content prior to publication. Please review the full disclaimers and compensation disclosures here which include further details: redditwire.com/terms. We are not responsible for third party analyst price targets or market estimates are refer to them based on publicly availble reports. Additional or competing price target may exist and readers are advised to refer to the full report and its respective disclaimers and disclosures. Contact Details Wall Street Wire Editorial Desk media.globalmarkets@gmail.com

June 02, 2025 09:19 AM Eastern Daylight Time

Market Alert: DarioHealth Receives $3 Price Target and Buy Rating: Everything You Need to Know

Global Markets News

Litchfield Hills Research has initiated coverage of DarioHealth Corp. (NASDAQ: DRIO)* with a Buy rating and a $3 price target, representing potential upside of over 350% from current trading levels of around $0.66 per share. This bullish outlook comes as the digital health company continues to transform its business model and expand its comprehensive chronic care platform. DarioHealth has successfully pivoted from a direct-to-consumer model to a B2B2C (business-to-business-to-consumer) approach since 2020. This strategic shift has allowed the company to leverage its consumer platform strengths while expanding sales to health plans and employers. The company's B2B2C recurring revenue grew by an impressive 398% year-over-year in Q4 2024, demonstrating strong market adoption. The analyst highlights Dario's proven track record of both organic growth and strategic acquisitions, including the recent Twill acquisition which has strengthened its multi-condition platform. This expansion has positioned Dario to address five of the most common, expensive chronic conditions through a single, integrated solution. The $3 price target is based on a discounted future earnings model with a 9% discount rate. The analysis assumes Dario will reach GAAP breakeven in the second half of 2026, continue strong revenue growth to reach $66.1 million in 2026, achieve non-GAAP operating income of $17.4 million in 2026, and show improving gross margins, exceeding 80% in its core B2B2C business. Importantly, the report demonstrates that even at the $3 target price, Dario would trade at approximately 2.2x projected 2026 sales, which is still below the peer average of 2.28x. The analyst suggests Dario should command a premium multiple given its high growth profile and comprehensive platform. The report highlights Dario's unique competitive advantages relative to peers in the digital health space. Unlike competitors who focus on single conditions, Dario offers a comprehensive platform addressing diabetes, hypertension, weight management, musculoskeletal pain, and behavioral health. When comparing current market cap to sales and enterprise value to sales multiples, Dario trades at substantial discounts – 81% below peers on market cap to sales ratio and 54% below peers on enterprise value to sales ratio. This valuation gap, combined with Dario's proven clinical outcomes and expanding market presence, forms the core of the analyst's bull case. A significant growth driver highlighted in the report is Dario's expansion into the GLP-1 weight management space. The company's research has shown that members using GLP-1 experienced significant reductions in blood glucose levels in the first five months with changes sustained throughout the year. With the GLP-1 market projected to reach $100 billion by 2030, Dario's comprehensive solution combining medication management with behavioral support positions it to capture market share in this rapidly growing segment. Strategic partnerships, including its recent collaboration with Rula Health, further strengthen Dario's offering by providing access to over 15,000 behavioral health providers nationwide. The company is also leveraging AI technology to reduce operating expenses, with projections suggesting a 20% reduction in expenses between Q4 2024 and Q4 2025 through AI-driven process optimization. Litchfield Hills projects Dario's revenue will grow to $35.9 million in 2025 and $66.1 million in 2026, with gross margins improving to nearly 70% by 2026. The company is expected to achieve operational cash flow breakeven by late 2025, with full profitability in the second half of 2026. The recent $25.6 million private placement has strengthened Dario's balance sheet, providing sufficient runway to execute its strategic plan. With a blue-chip client list that includes major employers like Amazon, Microsoft, and Google, as well as top insurers and pharmaceutical companies, Dario appears well-positioned to capitalize on the growing demand for integrated digital health solutions that deliver measurable clinical outcomes and positive ROI. Recent News from Dario: DarioHealth Reports First Quarter 2025 Financial and Operating Results Dario's Digital Health Solution Demonstrates Effectiveness in New Research Examining Flu Vaccination Awareness in High-Risk Populations DarioHealth Closes Strategic Refinancing of Existing Debt Facility of up to $50 Million to Provide Additional Operational Flexibility and Support Growth Initiatives * Legal Disclaimer & Disclosure: Nothing in this article constitutes financial or investment advice, nor does it represent an offer to buy or sell securities. This report is published by the Wall Street Wire platform & media network. The operators of Wall Street Wire are not registered brokers, dealers, or investment advisers. This article contains paid promotional content related to DarioHealth and was produced as part of their paid subscription to Wall Street Wire, which includes a monthly fee of five thousand US dollars paid in cash in return for promotional content and distribution services. The operators also receive additional fees for non promotional advisory and data services. DarioHealth did not necessarily review or approve this content prior to publication. Please review the full disclaimers and compensation disclosures here: redditwire.com/terms. We are not responsible for third party analyst price targets are refer to them based on publicly availble reports. Additional or competing price target may exist and readers are advised to refer to the full report and its respective disclaimers and disclosures. Contact Details Wall Street Wire Network media.globalmarkets@gmail.com

May 19, 2025 07:51 AM Eastern Daylight Time

Roberts & Ryan Inc. Welcomes Rear Admiral Matthew Ott (Ret.) to its Advisory Board

Roberts & Ryan, Inc.

Roberts & Ryan Inc., America’s first Service-Disabled Veteran-Owned Broker Dealer, is pleased to announce that Rear Admiral Matthew Ott (Ret.) has joined the firm’s Advisory Board. Mr. Ott is the founder and CEO of Ott and Associates and the firm On Target Together. He is a retired U.S. Navy Rear Admiral, where he served on amphibious assault ships, destroyers, and aircraft carriers and served across all levels of tactical, operational, and strategic warfare. Accomplished in command overseas and in the U.S., his service ranged from Secretary of Defense Staff, Defense Logistics Agency, U.S. Fleet Forces Command, Naval Supply Systems Command, and culminated in his third return to NAVSUP Weapon Systems Support, leading 2,500 team members across three sites, providing global supply chain management functions for 3,900+ aircraft and 300 ships, submarines, and nuclear reactors for the Navy, Marine Corps, and 80 global partners. A decorated 32-year career officer, Ott is a recognized authority on Supply Chain Management, Complex Systems Architecture, bridging Industry and Government, executing Humanitarian and Disaster Response, and creating tough, winning teams. Ott is best known for enhancing the Navy Sustainment System Supply Architecture as its key material director in the 41B strategic scale design of Navy-wide supply chains to run more effectively and affordably. The complex launches covered aviation, maritime, shipyard, maintenance repair and overhaul, nuclear, ordnance and subsistence markets. A Human Centered Design expert, he creates value using real-time visualization and horizontally integrates complex systems. His leadership, coaching, process discipline and refinement allow stakeholders to win in high stakes environments. His teams are creative, action-oriented, accountable, and focused on leveraging untapped potential to unlock value. Ott received a B.A. in Economics and Business from the Virginia Military Institute. He holds an MBA from the University of North Carolina at Chapel Hill with concentrations in Supply Chain Management and E-business and Digital Commerce. He is a distinguished graduate of the National Defense University’s Industrial College of the Armed Forces (ICAF), where he earned an M.S. in National Security and Resource Strategy. Ott is also Vice President, Partnerships and Alliances for Throughline, an Enterprise Strategy and Design firm where he will continue to bring his military ethos to the commercial world. He speaks about lessons learned, applicability of cross-functional approaches, and applies frameworks to complex problems in the defense, commercial, start-up, small business, and NGO spaces. He is available to serve C-Suite advisory level and teams to be On Target Together. For more on his U.S. Navy Background, please visit the U.S. Navy Website. About Roberts and Ryan, Inc. Roberts & Ryan, Inc. is a Service-Disabled Veteran Owned (SDVO) broker-dealer with execution capabilities in the capital markets, equities, and fixed-income trading. The firm was founded in 1987 by a United States Marine Corps Vietnam combat veteran and Purple Heart recipient. With over $2.38 million in committed donations, Roberts & Ryan is active in donating to charitable foundations that make significant positive impacts in the lives of Veterans and their families, focusing primarily on general wellness, mental health, and career transition. To learn more about Roberts & Ryan, please visit www.roberts-ryan.com. Securities are offered by Roberts & Ryan Inc., member FINRA | SIPC | MSRB | NYSE | NASDAQ. Contact Details Michael C. Del Priore +1 646-859-4061 mdelpriore@roberts-ryan.com Company Website https://www.roberts-ryan.com

May 12, 2025 09:00 AM Eastern Daylight Time

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Nuvectis Pharma's NXP900: Could This Revolutionary Cancer "Inactivator" Transform Oncology Treatment?

Global Markets News

Investors seeking the next breakthrough in precision oncology may want to take note of Nuvectis Pharma (NASDAQ: NVCT)*, a clinical-stage biopharmaceutical company developing, among other candidates, NXP900 - which a a new analysis is describing not merely as a cancer inhibitor, but a complete cancer pathway "inactivator." The new analysis, published on notable investment newsletter “ Truffle Pigs ”, provided a comprehensive review of Nuvectis Pharma’s NXP900. Beyond Traditional Inhibition According to the Truffle Pigs blog, NXP900 represents something entirely new in cancer treatment. Unlike traditional kinase inhibitors that merely slow cancer signaling, NXP900 is characterized as the "first SRC kinase inactivator" - a distinction that could prove crucial in the fight against resistant cancers. The analysis highlights that NXP900 functions as a "type 1.5 inhibitor" that locks the SRC kinase in its inactive state, effectively shutting down all cancer signaling pathways and keeping them disabled between doses. This complete inactivation mechanism potentially offers a significant leap beyond current therapies. Promising Clinical Data Recent data presented at the 2025 American Association for Cancer Research (AACR) meeting appears to support this thesis. According to the analysis, NXP900 demonstrated: Perhaps most intriguing were results showing that when combined with AstraZeneca's blockbuster drug osimertinib (Tagrisso), NXP900 demonstrated significant tumor regression and extended tumor control even after treatment ended - suggesting potential for durable responses or even complete responses in certain patients. Dual Market Opportunity The analysis notes two major market opportunities for NXP900: Single-agent therapy for SRC/YES1-driven tumors, potentially addressing approximately 20,000 lung cancer patients annually Combination therapy for overcoming acquired resistance to targeted drugs like osimertinib (EGFR) or lorlatinib (ALK), potentially addressing up to 70,000 non-small cell lung cancer patients annually While established companies like AstraZeneca generate nearly $7 billion annually from Tagrisso targeting approximately 20,000 new EGFR-mutated patients each year, Truffle Pigs' analysis suggests NXP900's broader applicability could potentially drive peak sales of $12-15 billion across various cancer indications. Investor Perspective With only 23 million shares outstanding and a current market cap of 219 million, Nuvectis represents a high-risk, high-reward opportunity typical of early-stage biotech. The company recently raised capital through a public offering of common stock, extending its cash runway into 2027 on what many would consider impressive terms given the market backdrop. Phase 1b trials targeting biomarker-selected cancers are expected to commence shortly, with potential clinical response data anticipated later this year.Notably, the original blog highlighted that that while the author held a position in Nuvectis Pharma (NASDAQ: NVCT), he was not compensated to write or publish the content. In other words, one might say that the author has “skin in the game”. As with all development-stage biotechnology companies, significant risks remain. analysis appropriately notes that as with all companies in the field - regulatory approval hurdles, high clinical failure rates, capital intensity, potential market competition, uncertain revenue streams, and broader economic factors all present considerable risks that investors should take into account when conducting their due dilligence. The full Truffle Pigs Blog post is available here: https://trufflepigs.substack.com/p/nuvectis-pharmas-nxp900-the-first Recent News From Nuvectis Pharma Nuvectis Pharma Provides Poster Presentation Highlights for NXP900 from the 2025 AACR Meeting Nuvectis Pharma Announces Upcoming Presentations for NXP900 at the 2025 American Association for Cancer Research Meeting Nuvectis Pharma Announces a New Publication of a Research Study Demonstrating that the Combination of NXP900 and EGFR Inhibitors Improves the Efficacy of the EGFR Inhibitors in Preclinical Models of EGFR Mutated NSCLC Legal Disclaimer & Disclosure: Nothing in this report constitutes financial or investment advice, nor does it represent an offer to buy or sell securities. This alert is published by Wall Street Wire™, a promotional content network and platform serving issuers around the globa. The operators of Wall Street Wire are not registered brokers, dealers, or investment advisers. This distribution is paid promotional content related to Nuvectis Pharma and was produced as part of their paid subscription to Wall Street Wire. This report has not been reviewed or approved by Nuvectis Pharma prior to publication. Please review the full disclaimers and compensation disclosures here: redditwire.com/terms. Readers are advised to refer to the full original blog post mentioned in the report and the disclosures it may be subject to. Contact Details WALL STREET WIRE Editorial Desk media.globalmarkets@gmail.com

May 05, 2025 01:59 PM Eastern Daylight Time

Nutriband Inc (NASDAQ: NTRB) Solution To Fentanyl Abuse Could Translate To $200 Million In Peak Revenue

NTRB

Nutriband Inc. (NASDAQ:NTRB) is a pharmaceutical company with a specific focus on developing a portfolio of transdermal pharmaceutical products. The company’s lead product under development is AVERSA™ Fentanyl, which is on track to becoming the first-ever abuse-deterrent transdermal fentanyl patch. AVERSA Fentanyl is currently pursuing a 505(b)(2) registration pathway, which should make it eligible for a more expedited review. For context, AVERSA is Nutriband’s proprietary technology that can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with the potential for abuse, like opioids. What makes AVERSA unique is its aversive agent coating, which leverages taste aversion to deter oral abuse and accidental exposure to transdermal opioid patch products. More than 70% of fentanyl patch abusers choose oral routes to abuse, so taste aversion addresses primary routes of abuse. That means AVERSA technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, such as fentanyl, while making sure that these drugs remain accessible to those patients who really need them. In one of the company’s recent major corporate milestones, Nutriband announced that it had received notification that its patent had been granted in Macao, which protects its AVERSA abuse-deterrent transdermal technology. The technology is now covered by a broad international intellectual property portfolio with patents issued in 46 countries, including the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia, as well as two regions of China: Hong Kong and Macao. Interestingly, the company hasn't been structured to follow the typical biotech standard when it comes to time and cost. The company already has two revenue-generating subsidiaries, 4P Therapeutics and Pocono Pharmaceutical, along with Active Intelligence, which specializes in sports recovery products. Nutriband’s revenues keep its development burn at a minimum. The company also owns its manufacturing and clinical development capabilities, which significantly reduces its costs for AVERSA and other technologies. Most notably, Nutriband partnered with Kindeva Drug Delivery to develop AVERSA Fentanyl, which combines Nutriband’s AVERSA abuse-deterrent technology with Kindeva’s FDA-approved fentanyl patch. Kindeva Drug Delivery is a leading global contract development and manufacturing organization (CDMO) that has a rich history in pharmaceutical innovation and manufactures millions of transdermal patches distributed worldwide. This strong partnership for AVERSA Fentanyl’s commercial development has led to significant progress in the abuse-deterrent patch’s development and manufacturing. Recently the two companies revised their agreement to formalize their exclusive product development partnership and long-term commitment based on shared development costs in exchange for milestone payments. At the same time, Nutriband revealed that it had signed an Associate Partnership agreement with Charlotte FC, which would be instrumental in helping build visibility for its brands, such as AI Tape. Management noted, “We are very excited to partner with an organization such as Charlotte FC as an Associate Partner. Manufacturing many of our products locally in the Charlotte region through our Pocono subsidiary makes this relationship special.’’ AVERSA’s addressable market is huge, depending on how you look at it. For instance, accidental fentanyl misuse is a growing problem, as illustrated by a recent report that revealed there had been 32 cases of accidental fentanyl exposure, which occurred, resulting in 12 deaths and dozens of hospitalizations, mostly involving young children. This is where the technology comes into play, as it significantly reduces the likelihood of accidental exposure to fentanyl for children. Furthermore, AVERSA Fentanyl is well aligned with the FDA’s Opioids Action Plan mission to expand access to abuse-deterrent formulations (ADFs) and to reduce the risks of misuse not just by the patient but also by other persons who obtain opioids. Upon approval of AVERSA fentanyl, the company expects that the FDA will consider requiring all fentanyl patches to be abuse deterrent, as was required for all oxycontin generics, which could potentially translate to more market share. To put the opportunity here into better context, consider this. According to Health Advances’ assessment, once approved by the FDA, AVERSA Fentanyl is expected to reach peak annual sales of about $200 million. The company believes that conservative pricing will be a key component of capturing and maintaining market share in addition to real-world data and marketing. According to the Health Advances’ report on AVERSA Fentanyl, Nutriband can expect to comfortably charge a 20% premium versus generics while maintaining insurance coverage and support, ideally capturing the market as the safest fentanyl patch in its class. Disclaimers: RazorPitch Inc. "RazorPitch" is not operated by a licensed broker, a dealer, or a registered investment adviser. This content is for informational purposes only and is not intended to be investment advice. The Private Securities Litigation Reform Act of 1995 provides investors a safe harbor in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions, or future events or performances are not statements of historical fact and may be forward-looking statements. Forward-looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties that could cause actual results or events to differ materially from those presently anticipated. Forward-looking statements in this action may be identified through the use of words such as projects, foresee, expects, will, anticipates, estimates, believes, understands, or that by statements indicating certain actions & quote; may, could, or might occur. Understand there is no guarantee past performance will be indicative of future results. Investing in micro-cap and growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investor's investment may be lost or impaired due to the speculative nature of the companies profiled. RazorPitch has been retained and compensated by Awareness Consulting LLC to assist in the production and distribution of this content. RazorPitch is responsible for the production and distribution of this content. It should be expressly understood that under no circumstances does any information published herein represent a recommendation to buy or sell a security. This content is for informational purposes only; you should not construe any such information or other material as legal, tax, investment, financial, or other advice. Nothing contained in this article constitutes a solicitation, recommendation, endorsement, or offer by RazorPitch or any third-party service provider to buy or sell any securities or other financial instruments. All content in this article is information of a general nature and does not address the circumstances of any particular individual or entity. Nothing in this article constitutes professional and/or financial advice, nor does any information in the article constitute a comprehensive or complete statement of the matters discussed or the law relating thereto. RazorPitch is not a fiduciary by virtue of any persons use of or access to this content. Contact Details RazorPitch Mark McKelvie +1 585-301-7700 mark@razorpitch.com Company Website http://razorpitch.com

April 30, 2025 07:00 AM Eastern Daylight Time

Roberts & Ryan Earns Prestigious VETS Indexes 5-Star Employer Award for 2025

Roberts & Ryan, Inc.

Roberts & Ryan, Inc., a Service-Disabled Veteran-Owned broker-dealer, is honored to receive the 2025 VETS Indexes 5-Star Employer Award — one of the program’s highest distinctions. This award celebrates the firm’s strong and ongoing dedication to hiring, developing, and supporting veterans, military spouses, and members of the National Guard and Reserves. The VETS Indexes 5-Star Employer distinction is reserved for organizations that demonstrate a sustained and comprehensive approach to veteran employment, retention, and support. Roberts & Ryan joins a select group of top-performing employers nationwide that serve as role models for veteran-focused workforce development. “Roberts & Ryan has demonstrated exceptional support for veterans and the military-connected community, earning the organization one of the most prestigious awards possible in the VETS Indexes Employer Awards program,” said George Altman, president of VETS Indexes. “Roberts & Ryan is among the very best veteran employers, and its program can serve as a model for others.” Roberts & Ryan’s recognition highlights the firm’s ongoing efforts to support service members transitioning to civilian careers. As a veteran-founded company, Roberts & Ryan understands the unique strengths and experiences veterans bring to the workforce and actively integrates that perspective into its hiring practices, workplace culture, and community outreach. “As a Service-Disabled Veteran-Owned Business, supporting the military-connected community is part of our DNA,” said Edward D’Alessandro, CEO at Roberts & Ryan. “This award reflects our deep commitment to honoring those who serve and not just through employment, but through opportunity, growth, and lasting impact.” The VETS Indexes 5-star Employer award was granted on April 11, 2025 Recipients of the VETS Indexes Employer Awards are selected based on their responses to VETS Indexes’ groundbreaking survey, which examines the most important veteran employment metrics via a granular, objective, and data-focused questionnaire. There was no compensation paid or received for consideration of the award. To view the full list of 2025 VETS Indexes Employer Awards recipients, visit: https://vetsindexes.com/award-results-2025 About Roberts and Ryan, Inc. Roberts & Ryan, Inc. is a Service-Disabled Veteran Owned (SDVO) broker-dealer with execution capabilities in the capital markets, equities, and fixed-income trading. The firm was founded in 1987 by a United States Marine Corps Vietnam combat veteran and Purple Heart recipient. With over $2.38 million in committed donations, Roberts & Ryan is active in donating to charitable foundations that make significant positive impacts in the lives of Veterans and their families, focusing primarily on general wellness, mental health, and career transition. To learn more about Roberts & Ryan, please visit www.roberts-ryan.com. Securities are offered by Roberts & Ryan Inc., member FINRA | SIPC | MSRB | NYSE | NASDAQ. Contact Details Michael C. Del Priore +1 646-859-4061 mdelpriore@roberts-ryan.com Company Website https://www.roberts-ryan.com

April 29, 2025 09:10 AM Eastern Daylight Time

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