News Hub | News Direct

RedHill's Opaganib Shows Diabetes And Obesity Potential With Positive In Vivo Results

Benzinga

By Meg Flippin, Benzinga A potential, previously unexplored pathway for fighting diabetes and obesity-related disorders may have been unveiled by RedHill Biopharma (NASDAQ: RDHL), a specialty biopharmaceutical company, and its partner Apogee Biotechnology Corp., who are busy developing what may be an interesting new approach in the obesity and diabetes market. The company is testing opaganib in a range of metabolic disease models designed to show its potential to prevent and treat type 2 diabetes and other obesity-related diseases and recently received positive in vivo results. The positive results of early trials are good news for RedHill Biopharma given the global obesity-diabetes drug market opportunity is huge, projected to reach $100 billion by 2030. It’s being driven largely by Glucagon-like peptide-1 (GLP-1) inhibitors like Novo Nordisk’s (NYSE: NVO) Ozempic and Wegovy (semaglutide), Eli Lilly’s (NYSE: LLY) Trulicity (dulaglutide) and Mounjaro (tirzepatide) and sodium glucose cotransporter-2 (SGLT2) inhibitors such as Boehringer Ingelheim’s Jardiance (Empagliflozin), reports RedHill. If RedHill is right about opaganib, it could join those ranks. “Sphingolipid metabolism is implicated in insulin resistance, β-cell disruption, adipocyte function, inflammation and immune regulation, vascular complications and energy metabolism – all significant components of obesity, diabetes and their associated complications,” said Charles D. Smith, Ph.D. Founder and CEO of Apogee Biotechnology Corp., Redhill’s partner who led the testing of opaganib for the treatment and prevention of type 2 diabetes and other obesity-related disorders. “Opaganib’s ability to modulate multiple signaling pathways through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells provides a strong rationale for evaluation of opaganib in obesity-related disorders.” Opaganib Slows Weight Gain Earlier this week RedHill announced that in vivo studies conducted by RedHill’s partner, Apogee, yielded positive results. The studies looked at the impact opaganib had on weight gain and glucose tolerance in a high-fat diet (HFD) model. They demonstrated opaganib suppressed HFD-induced body weight gain, loss of glucose tolerance and fat deposition. Additionally, opaganib reduced weight gain and restored glucose tolerance in an already obese HFD model, suggesting its potential for treating, not just preventing, obesity-related disorders, reports RedHill Biopharma. “Sphingolipid metabolism is a key pathway in many diseases, including obesity, but has not been adequately examined as a therapeutic target for human therapy,” said Dr. Mark Levitt, Chief Scientific Officer at RedHill. “Opaganib, which acts as a sphingosine competitor, is the first clinical drug to target three key enzymes in this pathway.” With multiple U.S. government collaborations ongoing, opaganib, RedHill Biopharma’s first-in-class new chemical entity with anti-inflammatory, anti-cancer and antiviral activity, is a host-directed, potentially broad-acting, orally administered small molecule drug with demonstrated safety & efficacy profiles. It is in development for multiple oncology, viral, inflammatory and diabetes and obesity-related indications, including COVID-19, Ebola, acute respiratory distress syndrome (ARDS) and radio/chemical protection. More Than Fighting Diabetes But it’s not just in fighting diabetes and obesity-related disorders where RedHill is making progress. Adding to its commercialization by RedHill in the U.S., the company just launched Talicia (omeprazole magnesium, amoxicillin and rifabutin) in the United Arab Emirates (UAE) – making it available by prescription to treat adults with Helicobacter pylori ( H. pylori ) infection. Talicia is the first approved low-dose rifabutin-containing all-in-one combination product in the UAE specifically designed to treat H. pylori. The commercial launch of Talicia in the UAE triggers RedHill’s eligibility for additional potential milestone payments, minimum sales payments and tiered royalties up to mid-teens on net sales. Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole). In November 2019, Talicia was approved by the U.S. FDA for the treatment of H. pylori infection in adults. In a pivotal Phase 3 study, Talicia demonstrated 84% eradication of H. pylori infection in the intent-to-treat (ITT) group vs. 58% in the active comparator arm (p<0.0001). “As one of the strongest risk factors for gastric cancer, H. pylori is a major public health concern,” said Rick Scruggs, President & Chief Commercial Officer at RedHill. “With 41% of the UAE population infected by H. pylori and the alarming failure rates of clarithromycin-based therapies, there is a significant medical need for a highly effective first-line H. pylori therapy. Our efforts to make Talicia available to patients in more countries continue as we work to explore additional opportunities with existing and potential partners.” From preventing diabetes and obesity-related diseases to fighting H. pylori, RedHill Biopharma seems to be making strides with its key drug compounds. Early testing shows promise, potentially making this a company worth watching. To learn more about RedHill Biopharma’s pipeline, click here. Featured photo by Diana Polekhina 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 23, 2024 08:30 AM Eastern Daylight Time

Image

News Release

Sector Spotlight: Top 4 Basket of Diagnostic Stocks (EXAS, GH, ILMN, LUDG)

LUDG EXAS GH ILMN

Big diagnostic companies soared during the pandemic thanks in part to mandated government testing, but once the at-home kits arrived and insurance companies were forced to foot the bill, diagnostic companies with COVID-19 revenues collapsed. Many diagnostic companies got caught in the downdraft because they thought the testing gravy train was going to continue and ramped up capacity instead of diversifying. The opportunity in the sector comes from diagnostic companies that chose to reinvent themselves by developing early cancer screening tests. During the pandemic, regular cancer screenings were put off to conserve medical resources toward COVID. Since the pandemic is over, it's worth reexamining beat-up diagnostic companies that were able to adapt and are now on the upswing. The top diagnostic stock to put on your radar is Exact Sciences (NASDAQ: EXAS). Most investors will recognize their at-home cancer screening kit is called cologuard which tests for colon cancer. Those primetime commercials you’ve likely heard mean they’ve established their brand along with a national audience. Testing volume dropped measurably during the pandemic as early cancer screening was pushed aside, but now their testing volumes are ramping back up and helping chew through the testing backlog created by the pandemic. It has taken a couple of years for EXAS testing volumes to return to pre-pandemic levels. In Q2 2024 the company had a record 1.0 million screenings and got back on its growth trajectory, helped by an expansion of cancer indications that include breast, prostate, and colon cancer. It also started its pipeline expansion into precision oncology. EXAS also made a move into a blood-based multi-cancer space when they purchased Thrive Early Detection Corp. for $2.15 billion. This purchase turned into a business vertical that not only does a deeper dive into the hereditary nature of the cancer but also profiles the tumor in such a way that it assists in the optimization of treatment regimens. The company has $2.6 billion in trailing revenues and a current market cap of $10.3 billion and is an overall leader in the diagnostic sector with solid earnings and a balance sheet for risk averse shareholders looking for a solid return from a company that consistently beats expectations. Guardant Health Inc. (NASDAQ: GH) has the first FDA-approved primary screening blood test for colorectal cancer (CRC). The test is called Shield and it is covered under the Medicare reimbursement program. Shield has a sensitivity of 83% and a 90% specificity (false positives) for advanced neoplasia (polyps that could turn cancerous). The company has $600 million in trailing revenues and a current market cap of $4.0 billion. They call it a non-invasive test, but you still have to get pricked. Another way to play the diagnostic market is to look at the top industry suppliers. llumina Inc. (NASDAQ: ILMN) is a medtech company that makes genetic testing equipment that enables the large-scale analysis of genetic variations. The company manufactures next-generation sequencing (NGS) platforms, microarrays, and bioinformatics software. Their machines are used in genomics research, clinical applications, and molecular diagnostics, which means their customers are research centers, pharma companies, academic institutions, and clinical research organizations. The company recently spun off their diagnostics business called Grail Inc. (NASDAQ: GRAL) which is an early cancer screening company for people that are not symptomatic, enabling a proactive approach to diagnosing cancer earlier. ILMN funded GRAL with a one-time cash payment of $923 million. The company's leading product is a multi-cancer early detection blood test called Galleri. The test screens for 50+ types of cancer by reading the DNA sequence. The backbone of the testing technology is from the Illumina platform and over 20,000 participants in large clinical trial studies. The test kits cost around $1100 each, and they are awaiting FDA approval for the test. Investors looking for a little more alpha should look at this diagnostic testing company disruptor and its game changing technology. Ludwig Enterprises Inc. (OTCMKTS: LUDG) is an exceptional OTC company in the diagnostic screening sector, boasting mRNA testing technology that has the potential to revolutionize the multibillion-dollar diagnostic screening industry with its less invasive tests. CEO Marvin S. Hausman MD stated, “mRNA is the language that interprets DNA and is the future of medicine.” Although the company currently has no revenue, it is gearing up for an exciting product launch in October, coinciding with Breast Cancer Awareness Month, which is expected to kickstart its revenue stream. To spearhead its viral marketing campaign, the company has enlisted a seasoned veteran. LUDG’s Lab Developed Test (LDT) will initially target breast cancer screening, but the technology can be easily adapted to other inflammatory-driven cancers. These LDTs are processed at the Genetics Institute of America, a CLIA lab, which allows for quicker product launches as they do not require FDA approval. The company has developed a unique cancer screening approach by measuring mRNA at the nucleotide level. Their test uses AI algorithms to create a personalized inflammatory index, comparing it to a database of over 3,200 mRNA samples collected from 40+ clinical centers over five years. This method, particularly for breast cancer, boasts a 97% test sensitivity, indicating when further evaluation is needed. The LUDG test kits will cost $249 and will follow proven successful direct-to-consumer viral marketing strategies driven by targeted machine learning algorithmic technologies. The CEO of LUDG Hausman has come out of retirement to lead this technology to commercialization. He is a Medical Doctor, Immunologist, and board certified Urological Surgeon. Investors in LUDG will have an experienced CEO at the helm with a proven track record of successful exits. One of his most notable exits was when he sold his NYSE company Medco Research to King Pharmaceuticals, which was ultimately acquired by Pfizer (NYSE: PFE). LUDG’s Revealia breast cancer test is very much like the EXAS Cologuard test. As investors move back into diagnostic stocks, these 4 represent a diversified basket every investor should put on their radar. 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 performance are not statements of historical fact 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 which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements in this action may be identified through 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 investors investment may be lost or impaired due to the speculative nature of the companies profiled. RazorPitch has been retained and compensated to assist in the production and distribution of content related to LUDG. 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 Inc Mark McKelvie +1 585-301-7700 mark@razorpitch.com Company Website http://razorpitch.com

August 23, 2024 06:00 AM Eastern Daylight Time

Navigate your Investment Roadmap with Select Sector SPDR ETFs

Select Sector SPDR

In an era where market dynamics shift as swiftly as the winds, Select Sector SPDR ETFs remain a beacon for investors aiming to harness the potential of sector-specific investments. Tailored to meet the diverse needs of both individual and institutional investors, these ETFs chart a course for strategic portfolio management by distilling the vast S&P 500 into accessible segments. Focused Investment Across Diverse Sectors Select Sector SPDR ETFs stand out by offering a focused approach to investing, breaking down the broad landscape of the S&P 500 into key sectors. This segmentation allows investors to pinpoint their investments according to specific economic areas, aligning their portfolios with their investment goals, risk assessments, and market perspectives. Below is a glimpse into the diverse holdings that form the core of the Select Sector SPDR ETFs: Communication Services Select Sector SPDR Fund (XLC): Zooms in on the telecommunications and media sectors, capturing the pulse of digital communication. Consumer Discretionary Select Sector SPDR Fund (XLY): Targets the vibrant consumer goods and services sector, from retail giants to entertainment behemoths. Consumer Staples Select Sector SPDR Fund (XLP): Focuses on essential consumer goods and services, providing stability in fluctuating markets. Energy Select Sector SPDR Fund (XLE): Powers through with a dedicated look at the energy sector, from fossil fuels to renewable resources. Financials Select Sector SPDR Fund (XLF): Encompasses the robust banking, investment, and insurance industries, the backbone of economic infrastructure. Health Care Select Sector SPDR Fund (XLV): Centers on the pharmaceuticals, healthcare equipment, and services sectors, addressing global health needs. Industrials Select Sector SPDR Fund (XLI): Broadens the horizon with manufacturing, construction, and logistics firms. Materials Select Sector SPDR Fund (XLB): Covers the foundational chemicals, construction materials, and packaging industries. Real Estate Select Sector SPDR Fund (XLRE): Opens doors to commercial real estate services and REITs. Technology Select Sector SPDR Fund (XLK): Accelerates into the information technology and electronics sectors, powering innovation and connectivity. Utilities Select Sector SPDR Fund (XLU): Illuminates the path with utility companies, ensuring the flow of essential services. A Path for Strategic Investment By offering a lens through which to invest in specific sectors, Select Sector SPDR ETFs enable investors to steer their portfolios with confidence and clarity. The ETFs’ commitment to transparency and strategic focus empowers investors to adapt and thrive amidst the ebb and flow of market conditions. In the evolving landscape of the financial markets, Select Sector SPDR ETFs stand as a testament to the power of targeted investment. Through detailed sector analysis and dedicated portfolio exposure, these ETFs offer a distinguished pathway for those seeking to refine their investment strategies with sector-specific allocations. About Select Sector SPDR ETFs Select Sector SPDR ETFs are a series of exchange-traded funds designed to provide investors with an effective way to engage in sector-specific investment strategies. By segmenting the S&P 500 into distinct sectors, Select Sector SPDR ETFs furnish investors with the tools necessary for targeted and strategic investment decisions. DISCLAIMER: This is a work of research and should not be taken as investment or financial advice. Therefore, Select Sector SPDRs or the publisher is not liable for any decision made based on the publication. About the Company: Select Sector SPDR ETFs offer flexibility and customization opportunities. Many investors have similar outlooks, but no two are exactly alike. Select Sector SPDR ETFs let investors select the sectors that best meet their investment goals. DISCLOSURES The S&P 500 Index is an unmanaged index of 500 common stocks that is generally considered representative of the U.S. stock market. The index is heavily weighted toward stocks with large market capitalizations and represents approximately two-thirds of the total market value of all domestic common stocks. The S&P 500 Index figures do not reflect any fees, expenses or taxes. An investor should consider investment objectives, risks, fees and expenses before investing. One may not invest directly in an index. Transparent ETFs provide daily disclosure of portfolio holdings and weightings All ETFs are subject to risk, including loss of principal. Sector ETF products are also subject to sector risk and nondiversification risk, which generally will result in greater price fluctuations than the overall market. Diversification does not eliminate risk. An investor should consider investment objectives, risks, charges and expenses carefully before investing. To obtain a prospectus, which contains this and other information, call 1-866-SECTOR-ETF (732-8673) or visit www.sectorspdrs.com. Read the prospectus carefully before investing. ALPS Portfolio Solutions Distributor, Inc., a registered broker-dealer, is distributor for the Select Sector SPDR Trust. Media Contact: Company: Select Sector SPDRs Contact: Dan Dolan* Address: 1290 Broadway, Suite 1000, Denver, CO 80203 Country: United States Email: dan.dolan@sectorspdrs.com Website: https://www.sectorspdrs.com/ *Dan Dolan is a Registered Representative of ALPS Portfolio Solutions Distributor, Inc. ALPS Portfolio Solutions Distributor, Inc., a registered broker-dealer, is the distributor for the Select Sector SPDR Trust. SEL007734 EXP 10/31/24 Contact Details Dan Dolan +1 203-935-8103 dan.dolan@sectorspdrs.com Company Website https://www.sectorspdrs.com/

August 22, 2024 05:00 AM Eastern Daylight Time

Continuous Blood Glucose Monitoring Can Materially Improve The Quality Of Life For People With Diabetes – Glucotrack Wants To Make It Easier

Benzinga

By Meg Flippin, Benzinga You can’t wing it when it comes to diabetes. Everything you eat and drink, the amount of physical activity you engage in and the medicines you take must be monitored closely. Keeping your blood glucose level within its target range is vital in preventing other medical issues. But managing diabetes can be cumbersome and intrusive. The main way of tracking glucose in your blood is via a glucose meter which requires you to prick your finger several times a day to get a sample of your blood. These meters provide blood glucose readings – which is considered the most accurate form of glucose monitoring – however testing must be done often and even then users can miss highs and lows in their glucose and the direction in which their glucose is changing. This type of monitoring is also a constant reminder of the disease. A More Modern Approach Continuous glucose monitoring (CGM) offers a better alternative. With it, your glucose level is monitored automatically through a device worn on the body 24 hours a day. It enables you to review your glucose levels to make well-informed decisions and adjust your behavior on a continual basis. These devices also enable people with diabetes to review how their glucose levels change over hours, days, weeks and months. Using a CGM device can help patients better manage glucose levels, reduce the number of low glucose events and decrease or eliminate the number of finger pricks. If your glucose rises or drops beyond a certain threshold, you’ll be alerted. The convenience is a big reason why the market for CGM devices is large and growing. In 2024 it is forecast to hit $16.2 billion and reach $44.6 billion by 2034, growing at a CAGR of 10.3%. Driving the demand is a need among patients to find a more convenient way to manage this chronic disease. After all, life doesn’t have to stop just because you have been diagnosed with diabetes. Diabetes is a disease that's growing in the U.S. and around the globe, impacting people of all ages. The total number of people around the globe who suffer from diabetes is projected to reach 643 million by 2030 and soar to 783 million by 2045. While adults are the most likely to be diagnosed with diabetes, it impacts children as well at a growing rate. Not Every CGM Device Is The Same But when it comes to CGM, not all devices are created equally. The duration that the monitoring lasts, the placement of the device, the type of glucose being tested and how often data is received differ from one manufacturer to the next. Take DexCom Inc. (NASDAQ: DXCM) for starters. Its CGM device consists of sensors worn under the skin that must be reapplied every 10 to 15 days, depending on the system, and which monitor glucose data every five minutes. The results are accurate but they measure interstitial glucose, which can lag 10 to 15 minutes behind blood glucose, so there is a delay versus blood glucose readings. Meanwhile, FreeStyle Libre by Abbott Laboratories (NYSE: ABT) is a CGM device that also monitors glucose from interstitial fluids just underneath the skin rather than glucose in the blood. It uses a sensor that is worn on the back of the arm and measures glucose every minute versus every five minutes. The sensor has to be reapplied every 14 or 15 days, depending on the system. Eversense, a CGM device made by Senseonics Holdings Inc. (NYSE: SENS), is another type that works by implanting a small sensor under your skin, along with a transmitter worn on top of the skin. It measures the glucose in interstitial fluids every five minutes and the sensor works for up to 180 days before it needs to be swapped out. While all these devices are much easier to use than multiple finger pricks a day, they do require some intervention after a period of time and don’t measure glucose in the blood. And, they each require an on-body wearable, so there is the possibility of skin irritation and sensors falling off early or during physical activities like swimming or hot yoga. Additionally, having a wearable on the body reduces the amount of discretion that some people with diabetes desire. A Potentially Better Way Glucotrack, Inc. (NASDAQ: GCTK) is different. The Rutherford, New Jersey, medical technology company focused on the design, development and commercialization of novel technologies for people with diabetes has developed a Continuous Blood Glucose Monitor (CBGM) that aims to overcome the challenges of today’s CGM, including delays due to the interstitial lag, the need for frequent sensor changes and concerns regarding comfort and wearability. Unlike the others on the market, Glucotrack's device measures glucose in the blood. Because Glucotrack’s implantable CBGM measures glucose in the blood, it doesn’t have the lag time associated with subcutaneous sensors that measure glucose in interstitial fluid. The ability to directly measure blood glucose in real-time and on a continuous basis enables a less burdensome approach to glucose monitoring for extended periods of time. Additionally, with no on body wearable, the CBGM offers increased discretion to the user, making it potentially less intrusive to daily living. What’s more, Glucotrack’s implant can last up to three years, compared to months for the other CGM devices on the market. Patients don’t have to worry about sticking an adhesive to their body or be concerned about it falling off during physical activity. And, with minimal calibration required, the CBGM eliminates the hassle and discomfort of a wearable that requires frequent replacement. Monitoring glucose and thus living with diabetes can become easier with Glucotrack. Proof Through Studies Glucotrack has data to back up its claim. It recently completed a second long-term preclinical study for its CBGM device, which showed a Mean Absolute Relative Difference (MARD) of 4.7% at day 90, which is considered highly accurate for a continuous glucose monitor, the company reports. MARD is a key metric used to assess the accuracy of glucose monitoring devices, measuring the average difference between the CBGM device’s measurement and a reference measurement, most often obtained via capillary blood glucose. Lower values indicate better performance, said Glucotrack. The company said the 90-day preclinical study, which included a larger number of animal subjects and a longer duration than the initial 60-day study announced earlier this year, further validates the CBGM sustained accuracy and performance. “We are again very pleased with the performance of our sensor during a long-term preclinical study and look forward to moving into human clinical trials” stated Paul Goode, Ph.D., president and CEO of Glucotrack. “Our CBGM’s ability to continuously measure blood glucose for three years with accuracy, minimal calibration and without a wearable represents a significant advancement in glucose monitoring. We believe this technology has the potential to greatly improve the quality of life for people with diabetes by providing a more convenient and discreet monitoring solution.” The company presented preclinical animal data and longevity data at the 84th Scientific Sessions of the American Diabetes Association (ADA) held Jun. 21-24, 2024 in Orlando, Florida. The company also provided market research data showing acceptability of the CBGM with a large number of people with diabetes at the Association of Diabetes Care and Education Specialists (ADCES) 2024 Annual Conference held Aug. 9-12, 2024, in New Orleans, Louisiana. Diabetes is a chronic disease that’s poised to impact hundreds of millions of people around the globe. Managing the disease today is cumbersome and intrusive, even with the technological advances that the current generation of CGM devices have brought. Glucotrack wants to change that and believes its device is the answer. If preclinical test results are any indication, the company may be on to something that could be life-transforming for people with diabetes. Featured photo by Sweet Life 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 21, 2024 08:30 AM Eastern Daylight Time

Image

News Release

The Future of Medicine: Key Biotech Stocks to Watch

OSTX ATNM PBYI CRBP

In today's rapidly advancing healthcare landscape, biotech companies are playing a crucial role in addressing some of the most challenging medical conditions. With a focus on innovation and precision, these companies are developing next-generation treatments and therapies that offer new hope for patients and present compelling opportunities for investors. Unlike many traditional sectors, biotech operates at the cutting edge of science and technology, often driving significant progress in areas such as targeted therapies, immunotherapies, and genetic research. As these companies push forward with their groundbreaking work, they not only stand to revolutionize patient care but also present promising prospects for those looking to invest in the future of medicine. Let’s take a closer look at four biotech companies making waves in the industry. OS Therapies, Inc. (NYSE-A: OSTX) OS Therapies, Inc. (NYSE-A: OSTX) is carving out a unique position in the oncology landscape with its innovative approaches to treating cancer. The company, still in its clinical stage, focuses on developing therapies for osteosarcoma and other solid tumors. Their flagship product, OST-HER2, utilizes a novel immunotherapy platform that leverages the immune-boosting properties of Listeria bacteria to target the HER2 protein—a key player in several cancers. The company's pipeline includes OST-HER2, an immunotherapy currently in a Phase 2b trial targeting resected, recurrent osteosarcoma. With the trial fully enrolled and results expected in the fourth quarter of 2024, investors are keenly awaiting data that could significantly impact the stock’s trajectory. OST-HER2 has already garnered notable designations such as Fast-Track, Orphan Drug, and Rare Pediatric Disease from the FDA, underscoring its potential to address unmet medical needs. In addition to OST-HER2, OSTX is advancing its tunable Antibody Drug Conjugate (tADC) platform. This next-generation technology employs pH-sensitive silicon-based linkers, known as SiLinkers, designed to deliver multiple therapeutic agents directly to tumors, minimizing harm to healthy cells. Early preclinical data from this platform shows promise, positioning OS Therapies as a company with innovative solutions that could transform cancer treatment. Recent milestones further highlight the company’s growth potential. OSTX successfully raised $6.4 million in its initial public offering (IPO) on July 31, 2024. This funding not only bolsters their financial position but also supports ongoing and upcoming clinical trials. Additionally, the company has entered into Johnson & Johnson Innovation – JLABS, which could enhance its development capabilities and expand its research network. Financially, OSTX has made significant strides. The conversion of outstanding preferred shares and debt into equity, alongside the successful IPO, positions OS Therapies with a solid cash runway extending into mid-2025. This financial stability is critical as they approach key clinical milestones and seek further regulatory approvals. On August 2, 2024, OS Therapies announced the formation of a Patient Advocacy Advisory Board (PAAB) dedicated to its osteosarcoma program. The PAAB, composed of key figures from the osteosarcoma community, including Miriam Cohen (Osteosarcoma Collaborative) and Mac Tichenor (Osteosarcoma Institute), will provide valuable insights and feedback as the company seeks regulatory approvals for OST-HER2. This board will meet quarterly to review clinical progress and guide discussions with the FDA regarding a potential Biologics License Authorization (BLA). Additionally, on August 6, 2024, OS Therapies introduced its Scientific and Medical Advisory Board (SMAB). This board includes leading experts in osteosarcoma from institutions such as Texas Children’s Hospital and the Cleveland Clinic. The SMAB will support the company in evaluating OST-HER2’s safety and efficacy compared to current standards of care, playing a crucial role in the company’s regulatory strategy and potential BLA submission. OS Therapies’ approach to addressing significant cancer challenges through its innovative platforms presents an intriguing opportunity for investors. With strong initial results, a promising pipeline, and a strategic partnership with JLABS, the company is well-positioned for future growth. For those looking to invest in a company at the forefront of cancer immunotherapy and antibody drug conjugates, OSTX offers a compelling proposition. Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) CRBP is making notable strides in oncology with its innovative approach to addressing serious diseases. The company's diversified pipeline includes CRB-701, CRB-601, and CRB-913, each with unique mechanisms and promising potential. Corbus’ lead asset, CRB-701, is a next-generation antibody drug conjugate (ADC) targeting Nectin-4. Recently presented at the American Society of Clinical Oncology (ASCO) Annual Conference, the Phase 1 trial results have been promising. The study, conducted with CSPC Pharmaceuticals Group, is assessing CRB-701's safety and efficacy across multiple doses. Data through April 2024 reveals a 44% overall response rate and a 78% disease control rate in metastatic urothelial cancer, and a 43% ORR and 86% DCR in cervical cancer. The drug has been well tolerated, with manageable side effects including a few cases of skin rash and peripheral neuropathy, and no dose-limiting toxicities observed up to 4.5 mg/kg.. For the quarter ending June 30, 2024, Corbus reported a net loss of approximately $10.0 million, an increase from the previous year. This rise in loss is attributed to increased clinical trial costs for CRB-701 and drug manufacturing costs for CRB-913. The company ended the quarter with $147 million in cash, which, combined with recent fundraising, is expected to sustain operations through Q3 2027. Corbus also appointed Winston Kung to its Board of Directors as of August 16, 2024. Kung’s extensive experience in both the pharmaceutical industry and investment banking is anticipated to provide valuable insights and guidance as Corbus advances its pipeline. The company also announced the resignation of Avery “Chip” Catlin from the Board, after over ten years of service. Corbus Pharmaceuticals is advancing through significant clinical and corporate milestones. The encouraging data for CRB-701 and the progress in other pipeline assets position the company for potential growth. Continued development and forthcoming data releases will be crucial in determining the long-term impact of these promising therapies. Puma Biotechnology, Inc. (NASDAQ: PBYI) Puma Biotechnology is dedicated to advancing cancer treatment, with a focus on its lead drug, NERLYNX. Approved for HER2-positive breast cancer, NERLYNX has faced fluctuating sales performance. In Q2 2024, the drug generated $44.4 million in revenue, a 14% decrease from the previous year, but still managed to beat analyst expectations despite a sequential decline of 24.2%. The product’s total prescriptions rose by 3% sequentially but fell 14% year-over-year. In addition to NERLYNX, Puma is developing alisertib, an aurora kinase A inhibitor. This drug, licensed from Takeda in 2022, is being evaluated in several trials. The Phase I/Ib study presented at the 2024 ASCO Annual Meeting demonstrated alisertib’s potential when combined with osimertinib for treating osimertinib-resistant EGFR-mutant non-small cell lung cancer (NSCLC). The study showed an 81% disease control rate and a median progression-free survival of 5.5 months. Notably, alisertib was more effective in patients with TP53 wild-type mutations, prompting Puma to adjust the trial focus accordingly. PBYI reported a net loss of $4.53 million for Q2 2024, a stark contrast to the profit of the same quarter last year. The drop in revenue and increased operating costs have been concerns, though the company’s revenues from NERLYNX and royalties met expectations. Looking ahead, Puma’s pipeline, particularly the alisertib studies, could be pivotal in shaping its future performance. With trials like ALISCA-Lung1 for small cell lung cancer and the upcoming ALISCA-Breast1 study, Puma aims to address significant gaps in cancer treatment. While current financials reflect challenges, the potential breakthroughs in its pipeline offer a promising outlook for long-term growth. Actinium Pharmaceuticals Inc. (NYSE-A: ATNM) ATNM focuses on targeted radiotherapies for oncology patients who have not responded to conventional treatments. Its primary products, Iomab-B and Actimab-A, are aimed at treating relapsed and refractory acute myeloid leukemia (AML), offering substantial growth potential if the company’s clinical trials continue to yield positive results. The company's most advanced candidate, Iomab-B, is in a Phase 3 SIERRA trial for AML patients undergoing bone marrow transplants. Despite a setback regarding its Biologics License Application (BLA), where the FDA requested an additional randomized trial, Iomab-B has shown promising results. The SIERRA trial met its primary endpoint of durable complete remission (dCR) with a p-value of less than 0.0001. This success places Actinium in a strong position, though further validation through additional trials will be key to unlocking its full market potential. Actimab-A, another late-stage candidate, is being tested as a targeted radiotherapy both as a single agent and in combination with other therapies for AML. These ongoing trials could drive stock performance, especially as the company expands its reach into various cancer therapies. Additionally, Iomab-ACT, a newer agent, shows promise in the growing gene and cell therapy space. The targeted radiotherapy conditioning approach of Iomab-ACT could revolutionize how treatments like CAR-T and gene therapies are delivered. The CAR-T market, currently valued at over $3.5 billion in annual revenue, is projected to grow at a compound annual growth rate of 11%. If Iomab-ACT proves successful, it could capture a significant portion of this expanding market, potentially contributing blockbuster-level revenue by 2030. Actinium’s intellectual property portfolio supports this potential, with patent protection for Iomab-B and Iomab-ACT extending until 2040. The company’s ability to further develop these products, particularly in collaboration with institutions like Columbia University, presents a compelling investment case as it seeks to expand into high-demand areas like sickle cell disease and stem cell therapies. 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 performance are not statements of historical fact 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 which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements in this action may be identified through 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 investors investment may be lost or impaired due to the speculative nature of the companies profiled. RazorPitch has been retained and compensated by OS Therapies Inc. to assist in the production and distribution of content related to OSTX. 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

August 21, 2024 05:00 AM Eastern Daylight Time

Andrew Klein, M.D. named UNOS Chief Medical Officer

United Network for Organ Sharing

The United Network for Organ Sharing (UNOS) announced today that it selected Andrew S. Klein M.D., M.B.A., F.A.C.S. as Chief Medical Officer. “Dr. Klein has long been one of the most respected transplant surgeons and clinical researchers in the country,” said UNOS CEO Maureen McBride. As Chief Medical Officer, Dr. Klein will serve as an expert medical and clinical resource to other UNOS staff, the organ donation and transplant community, and the public. He will assist UNOS staff with research projects and publications and provide medical and clinical perspectives in UNOS corporate initiatives. “During his 35 years in clinical transplantation, Dr. Klein led transformational culture change and leads with an emphasis on inclusivity, engagement, transparency, and communication – the type of leadership the organ donation and transplant community needs during this time of modernization of the nation’s transplant system. Dr. Klein’s expertise will support UNOS’ continued growth as a global leader in donation, transplant, and health.” Dr. Klein was the founding Director of the Johns Hopkins Comprehensive Transplant Center from 1996 – 2003 and of Cedars-Sinai Comprehensive Transplant Center from 2004 to 2022. Honors include Clinician Scientist and Distinguished Alumnus awards from The Johns Hopkins University, Healthcare Visionary Award from the American Liver Foundation, and most recently, induction into the Johns Hopkins Society of Scholars. Dr. Klein has a long history of volunteer leadership with the Organ Procurement and Transplantation Network and many professional societies including the American Society of Transplant Surgeons, American Association for the Study of Liver Diseases, and the International College of Surgeons. Dr. Klein received his undergraduate degree from Duke University and his M.D. and M.B.A. degrees from The Johns Hopkins University and completed fellowships at Harvard University and the David Geffen School of Medicine at UCLA. About UNOS The United Network for Organ Sharing (UNOS) is a nonprofit organization that serves the organ donation and transplant system and broader public health community through its work developing new technologies and initiatives, conducting data-driven research and analysis, providing expert consulting services, advocating for patients, and being a leader in bringing communities together to save lives. Contact Details Anne Paschke +1 804-782-4730 anne.paschke@unos.org Company Website https://unos.org

August 20, 2024 03:30 PM Eastern Daylight Time

Image

AmeriLife Wealth Distribution and Peak Financial Freedom Group Announce Strategic National Partnership

AmeriLife

AmeriLife Group, LLC (“AmeriLife”), a national leader in developing, marketing, and distributing life and health insurance, annuities, and retirement planning solutions, announced today that it has partnered with the Peak group of companies, which include a comprehensive retirement income planning company, Peak Financial Freedom Group; an insurance distribution company, PFFG Insurance Agency; and a registered investment advisor (RIA), Fiduciary Solutions. Per the agreement, the terms of the deal were not disclosed. Based in Roseville, California, Peak Financial is renowned for its comprehensive written retirement income plans, wealth management services, and unwavering dedication to customer care and success. In addition, they have worked with TruChoice Financial, an AmeriLife subsidiary, helping other financial professionals across the US increase their production by 40%. Peak Financial Freedom Group CEO Jim Files and President Dan Ahmad are enthusiastic about the partnership, stating, "Joining forces with AmeriLife represents a pivotal step forward in our mission to empower clients with holistic financial strategies. We are committed to this partnership and its remarkable benefits for our customers, AmeriLife’s Wealth Distribution platform, and its growing affiliate-partner program." As Peak Financial Freedom Group brings a strong focus on marketing through seminars, client events, a radio talk show, and a multi-episode TV show to AmeriLife’s growing Wealth Distribution organization, the group is committed to fostering an environment of continuous learning and professional development programming, emphasizing a shared commitment to excellence in financial and wealth advisory services. With unfettered access to AmeriLife’s leading distribution platform, services, and resources, the company is poised to accelerate its impressive growth while serving more clients. “What Jim and Dan have created and nurtured with the Peak Group serves as an exemplary partnership model, offering world-class levels of customer service and relationship-building philosophies that have uniquely positioned the company above and beyond market competitors,” said Mike Vietri, Chief Distribution Officer of AmeriLife Wealth Group. “This partnership will allow us to expand our service offerings while elevating our commitment to offer superior consumer satisfaction to deliver even more value to our clients.” ### About Peak Financial Freedom Group Peak Financial Freedom Group, based in Roseville, CA, is committed to empowering individuals to achieve financial independence through tailored retirement income strategies. Specializing in conservative, risk-reducing investment approaches, the firm safeguards assets against market volatility, focusing on growth and creating dependable lifetime income. Offering comprehensive financial planning and investment management services, Peak Financial Freedom Group caters predominantly to retirees and those nearing retirement. The company’s affiliates, Fiduciary Solutions, LLC and PFFG Insurance Agency, LLC, enhance its capability to offer financial solutions under a unified brand. Dedicated to client education and satisfaction, Peak Financial Freedom Group endeavors to simplify the retirement planning process, ensuring its clients a seamless and secure financial future. For more information, visit the Peak Financial Freedom Group website. About AmeriLife AmeriLife’s strength is its mission: to provide insurance and retirement solutions to help people live longer, healthier lives. In doing so, AmeriLife has become recognized as a leader in developing, marketing, and distributing life and health insurance, annuities, and retirement planning solutions to enhance the lives of pre-retirees and retirees across the United States. For over 50 years, AmeriLife has partnered with top insurance carriers to provide value and quality to customers through a distribution network of over 300,000 insurance agents and advisors and 120 marketing organizations and insurance agency locations nationwide. For more information, visit AmeriLife.com and follow AmeriLife on Facebook and LinkedIn. Contact Details AmeriLife Jeff Maldonado media@amerilife.com Partnership Inquiries Patrick Nichols corporatedevelopment@amerilife.com Company Website https://amerilife.com/

August 20, 2024 09:00 AM Eastern Daylight Time

MCC Brokerage Named One of America’s Fastest-Growing Private Companies by Inc. 5000

AmeriLife

MCC Brokerage, an innovative field marketing organization in the life and health insurance industry and affiliate partner of AmeriLife Group, LLC, today announced its first inclusion on Inc. 5000’s annual list of the fastest-growing private companies in America. With over 25 years of agency management experience, MCC Brokerage has built a robust network of resources designed to support licensed agents with top-flight resources, marketing and lead programming, compliance training and guidance, and its flagship professional development program, MCC Academy. “I am deeply honored and humbled that our company has been recognized in the Inc. 5000 list for the first time in our history,” said Darren Houck, CEO of MCC Brokerage. “This achievement is a testament to our team's hard work and dedication. As we celebrate this milestone, I am reminded that accolades do not measure our success. Instead, it's the service and value we provide to our agents and agency principals daily. I am grateful to our team for their commitment to excellence, our clients for trusting us with their needs, and AmeriLife for its unwavering partnership and servant leadership.” “I am thrilled to congratulate Darren and the MCC Brokerage team on being recognized as one of America's Fastest Growing Companies by Inc. 5000,” added Scotty Elliott, Chief Distribution Office of Health for AmeriLife. “This prestigious accolade is a testament to their relentless dedication, innovative spirit, and exceptional leadership. We are proud to partner with such a forward-thinking organization and are excited to see what heights their continued growth will lead to in the future.” The prestigious ranking provides a data-driven look at the most successful companies within the economy’s most dynamic segment—its independent, entrepreneurial businesses. In addition to Microsoft, Meta, Chobani, Under Armour, Timberland, Oracle, Patagonia, and many other household-name brands, MCC Brokerage gains its first national exposure as an honoree on this year’s Inc. 5000 list of the fastest-growing private companies in the country. The Inc. 5000 class of 2024 represents companies that have driven rapid revenue growth while navigating inflationary pressure, the rising costs of capital, and seemingly intractable hiring challenges. Among this year’s top 5000 companies, the average median three-year revenue growth rate is 1,637 percent. This year’s Inc. 5000 companies have added 874,458 jobs to the economy over the past three years. “One of the greatest joys of my job is going through the Inc. 5000 list,” says Mike Hofman, who recently joined Inc. as editor-in-chief. “To see all the intriguing and surprising ways companies are transforming sectors, from health care and AI to apparel and pet food, is fascinating as a journalist and storyteller. Congratulations to this year’s honorees, as well, for growing their businesses fast despite the economic disruption we all faced over the past three years, from supply chain woes to inflation to changes in the workforce.” The 2024 Inc. 5000 companies are ranked according to percentage revenue growth from 2020 to 2023. Companies must have been founded and have generated revenue by March 31, 2020, to qualify. They must be U.S.-based, privately held, for-profit, and independent—not subsidiaries or divisions of other companies—as of December 31, 2023. ### About MCC Brokerage As an award-winning, highly reputable, and innovative field marketing organization in the life and health insurance industry, MCC Brokerage works to empower thousands of active, licensed independent insurance agents nationally. MCC has created an exclusive marketing catalog for agents to choose customizable collateral with consistent looks across all pieces to build their brand in the community. For more information, visit www.mccbrokerage.com. About Inc. Inc. Business Media is the leading multimedia brand for entrepreneurs. Through its journalism, Inc. aims to inform, educate, and elevate the profile of our community: the risk-takers, the innovators, and the ultra-driven go-getters who are creating our future. Inc. ’s award-winning work achieves a monthly brand footprint of over 40 million across various channels, including events, print, digital, video, podcasts, newsletters, and social media. Its proprietary Inc. 5000 list, produced yearly since its launch as the Inc. 100 in 1982, analyzes company data to rank the fastest-growing privately held businesses in the United States. The recognition that comes with inclusion on this and other prestigious Inc. lists, such as Female Founders and Power Partners, allows the founders of top businesses to engage with an exclusive community of their peers and credibility that helps them drive sales and recruit talent. For more information, visit www.inc.com. About AmeriLife AmeriLife’s strength is its mission: to provide insurance and retirement solutions to help people live longer, healthier lives. In doing so, AmeriLife has become recognized as a leader in developing, marketing, and distributing life and health insurance, annuities, and retirement planning solutions to enhance the lives of pre-retirees and retirees across the United States. For over 50 years, AmeriLife has partnered with top insurance carriers to provide value and quality to customers through a distribution network of over 300,000 insurance agents and advisors and 120 marketing organizations and insurance agency locations nationwide. For more information, visit AmeriLife.com and follow AmeriLife on Facebook and LinkedIn. Contact Details Jeff Maldonado media@amerilife.com Partnership Inquiries Patrick Nichols corporatedevelopment@amerilife.com Company Website https://amerilife.com/

August 19, 2024 12:37 PM Eastern Daylight Time

Minerva Surgical Appoints Darin Hammers as Chief Executive Officer and Member of the Board of Directors

Minerva Surgical, Inc.

Today, Minerva Surgical announced the appointment of Darin Hammers as the new President and Chief Executive Officer and Member of the Board. With a 30-year proven track record of success and excellence, Mr. Hammers brings a wealth of expertise and leadership to the company as it continues to develop and commercialize minimally invasive gynecologic technologies that improve patient outcomes. Most recently, Mr. Hammers served as President and Chief Executive Officer of EndoGastric Solutions (EGS), which was acquired by Merit Medical in July. Prior to EGS, he served as Chief Executive Officer of DYSIS Medical and President and Chief Executive Officer of Cogentix Medical, a company that was acquired by Laborie in 2018. Mr. Hammers was formerly Vice President of Sales for the Bard Medical Division of C.R. Bard, and he spent over twelve years in leadership positions with the Urology and Gynecology division at Boston Scientific Corporation. During his tenure in the medical device industry, Mr. Hammers consistently demonstrated the ability to build high-performing organizations and teams that deliver exceptional results. Minerva Surgical Chairman Dr. Uri Geiger said: “We are delighted to welcome Darin as our new President and Chief Executive Officer. Mr. Hammers is a dynamic business leader with exceptional strategic capabilities, proven operational effectiveness and strong experience in women’s health. The Board looks forward to working with Darin as we grow Minerva’s platform of exceptional products for women’s care.” Mr. Hammers stated: “I am delighted to join Minerva Surgical and build a company that will develop new and innovative technologies to improve the quality of life for women. The core portfolio of products is as effective as any on the market when it comes to treating uterine cavity conditions, and the goal is to expand our footprint in the gynecology space and become a market leader.” Darin Hammers holds an MBA from Emory University’s Goizueta School of Business and a Bachelor of Science degree in marketing from the University of Southern Indiana. About Minerva Surgical, Inc. Minerva Surgical is a commercial-stage medical technology company focused on developing, manufacturing, distributing, and commercializing minimally invasive solutions to meet the distinct uterine healthcare needs of women. The Company has established a broad product line of commercially available, minimally invasive alternatives to hysterectomy, which are designed to address the most common causes of Abnormal Uterine Bleeding (AUB) in most uterine anatomies. The Minerva Surgical solutions can be used in a variety of medical treatment settings and aim to address the drawbacks associated with alternative treatment methods and to preserve the uterus by avoiding unnecessary hysterectomies. For more information about the innovative medical devices of Minerva Surgical, please visit www.MinervaSurgical.com. Contact Details Minerva Surgical Kevin Tracey +1 855-646-7874 media@minervasurgical.com Company Website https://minervasurgical.com/

August 19, 2024 10:00 AM Eastern Daylight Time