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Tooth Decay Can Cost Up To $28,000 When Left Untreated — DentalPlans.com Helps Americans Get The Dental Care They Need At Steep Discounts

DentalPlans.com

By Rachael Green, Benzinga The most common chronic disease in the United States is tooth decay, with nearly 90% of adults between 20 and 64 having some decay in their teeth which can lead to tooth loss and gum disease if left untreated. As a result, an estimated 120 million Americans are missing at least one tooth and 36 million have no remaining teeth at all. However, 77 million Americans don’t have dental insurance, and even those that do still end up paying an average of $874 out of pocket per year for dental care because the coverage they do have is limited. Many dental insurance plans set their total annual maximum at around $1,500. Once a patient exceeds that limit for the year, they have to pay any remaining costs out of pocket. To understand just how easy it is to exceed the annual maximum of most plans, let’s look at the average costs, without insurance or a dental savings plan, of three common procedures: root canals, dental implants, and dentures. A Root Canal Can Cost Between $1,000 to $4,350 on Average Over 15 million root canals are performed every year in the United States. The procedure is used when untreated decay progresses all the way through the tooth and into the nerve, causing inflammation, infection, and a lot of pain. Root canals are essentially the last option for saving a tooth that has been left to decay for too long. In one large-scale study, it was found that teeth that received a root canal can survive an average of 20 more years. But that’s if the patient also received a crown and filling to restore the tooth afterward. For those that just received a root canal with no restorative work, the tooth survived an extra six and a half years on average—better than nothing, but not great. While pricing varies, a single root canal costs between $1,000 and $1,600 without insurance, depending on the location of the tooth. For patients who want restorative work that can extend the tooth’s life as much as possible, they’ll have to add between $50 and $250 for the filling and $900 to $2,500 for the crown. The total cost of a root canal, filling, and crown can vary between $1,950 and $4,350 without insurance. A Single Dental Implant Can Cost Up To $4,500 In the United States, 3 million people already have at least one dental implant and an estimated 500,000 new implants are placed each year nationwide. Each one of those tooth replacements costs about $3,000 to $4,500 on average without insurance, according to the American Dental Association (ADA). A full set can cost as much as $45,000 without insurance. A Full Set of Dentures Can Cost Up To $28,000 Given the high rates of tooth loss in the United States mentioned earlier, about 40 million Americans wear full or partial dentures, with a full set costing anywhere from $1,000 to $28,000 without insurance depending on permanence. Traditional removable dentures range from $1,000 to $3,000 while the more permanent implant-supported dentures average $21,500. Even for partial dentures or bridges for people who have only lost a few teeth, prices range from $450 for a temporary denture up to $3,100 for a permanent, custom-fitted denture without insurance. These costs don’t factor in the added costs of maintaining dentures including tissue conditioning to prepare gums for wearing dentures and periodic denture adjustments or relining to make sure they still fit even as gums change. Savings Plans on DentalPlans.com Can Make Life-Changing Oral Care Affordable To help curb the costs of important dental care, dental savings plans that provide plan members with big discounts on most procedures have emerged as an alternative to or supplement for traditional dental insurance. DentalPlans.com, a leading marketplace for dental savings plans since 1999, is helping Americans find the right plan for their needs so that they can afford the care they need. A dental savings plan is not insurance. That means anyone can join anytime throughout the year, and start saving quickly. Plans activate in just 1-3 business days. People just sign up for the plan that suits their needs, pay the fee to activate their membership, and then receive reduced rates each time they visit the dentist. Both routine preventative care and more expensive procedures like root canals, dental implants, and dentures mentioned above are discounted between 10% and 60% for plan members. Plan members have reported an average savings of 50% off.* All they have to do to get the discount is show their membership card to one of the more than 140,000 participating dentists nationwide. There are also no restrictions or exclusions based on current health conditions and no limits on how much can be saved each year. A dental savings plan can mean the difference between being able to afford the care needed or having to go without. To learn more about dental savings plans visit DentalPlans.com *Discount Health Program consumer & provider surveys indicate average savings of 50%. Savings may vary by provider, location, and plan. This article was originally published on Benzinga here. DentalPlans.com, founded in 1999, is a leading online marketplace for dental savings plans in the U.S., helping more than a million people to affordably access quality healthcare services. Our mission is to empower consumers with the tools, information, and services that they need to live happier, healthier lives. This post contains sponsored advertising content. This content is for informational purposes only and not intended to be investing advice. Contact Details Matthew Wong matthew.wong@wpromote.com Company Website https://www.dentalplans.com/

March 06, 2023 09:00 AM Eastern Standard Time

What is Reverse Factoring for Cannabis Businesses?

Canna Business Resources

Cash flow is an important aspect of business operations, but spending on needed supplies and other overhead doesn’t always align with income from sales. You may find yourself in a situation where you don’t have the cash on hand to pay supplier invoices promptly, even though you anticipate money coming in. This could be a major impediment to carrying on operations, which is why many businesses require an open line of credit to bridge the gap between expenses and income. This type of financing can be hard to come by for cannabis businesses because many major banks won’t serve the cannabis industry. But with the right cannabis lender, you have the opportunity to secure a range of financing options, including reverse factoring. What is reverse factoring, and how can it help your business account for fluctuations in cash flow? Read on to find out. What Exactly is Reverse Factoring? Reverse factoring is a financing solution that involves three parties — you, your lender/financial organization and your suppliers. Also referred to as supply chain financing, this process is initiated by you, the buyer, and involves paying off supplier invoices with financing and then paying the lender back when money comes in. This financing allows you to continue making needed purchases to keep your business going while you await income from sales. You can avoid the stress of unpaid invoices and unsteady business cash flow as well as the potential for harming relationships with suppliers because of late or missed payments. How Does Reverse Factoring Work? The process is relatively simple once you have an arrangement in place with a cannabis lender. It starts when you purchase supplies or products from a vendor. Your supplier then provides you with an invoice for the purchase. Typically, this is approved by your company and given to the lender offering an open line of credit. The supplier can request early payment, which the lender releases on your behalf and bills against your line of credit. The supplier receives payment, and you are responsible for paying the lender on the agreed schedule (perhaps monthly or at a set maturity date). Suppliers may pay a small fee for early payout, and you may be charged interest, depending on the amount of credit and when you pay. Examples of Reverse Factoring for Cannabis Businesses If you run a dispensary, you might cultivate/manufacture some of your own products, but likely, you also sell a range of products supplied by other brands. You must order these products regularly to keep store shelves stocked, but you’re essentially paying out of pocket until you sell the products, recoup your costs and earn revenue. The gap between buying products and selling them could leave you dealing with a dip in your cash flow. You might not have the money to pay for products you need to stimulate sales and income. What can you do? With accounts receivable/invoice financing or a reverse factoring line of credit, you can keep an open line to funding needed to pay supplier invoices in a timely manner, allowing you to continue placing needed orders for supplies while you await sales and revenue to cover the costs. Advantages of Reverse Factoring for Cannabis Businesses You may be hesitant to take on any form of lending as a business owner. It’s natural to worry about repaying not only borrowed funds but accrued interest. That said, having a backup in place to provide coverage between expenditure and income is not only helpful to your ongoing business operation, but there are also benefits for your suppliers as well. How the Supplier Benefits Your suppliers are dealing with some of the same issues you are when it comes to cash flow. They provide you with materials or manufactured goods that cost them money, but they’re waiting on you to pay for them. When you have credit lined up to pay them if your cash flow stalls, you give them the gift of predictability that allows them to keep their operations running smoothly. If they know they can count on timely payments, they’re better able to manage their business and keep supplying yours. How the Buyer Benefits The biggest advantage of receivables factoring for your cannabis company is that it allows you to optimize cash flow, alleviating the risk of supply chain collapse. When you have ready cash to pay for products, you can work with supplier payment terms and build long-lasting relationships that benefit your business long term. Keeping Cash Flowing in Your Marijuana Business Many forms of cannabis financing can help you expand and purchase equipment or real estate. Credit lines that allow you to manage cash flow are arguably the most important for maintaining uninterrupted operations. You might get away with paying suppliers late once or twice, but if you prove consistently unreliable, you’ll find yourself without a supplier. Keeping the cash flowing gives suppliers confidence in your ability to pay and helps you maintain strong relationships and a steady supply of product. Is Reverse Factoring Right for You? Unless you’re lucky enough to have a lot of money sitting in the bank to cover cash flow concerns, having a backup option like reverse factoring in place to cover lean times is essential. With a reliable income stream, you can find a suitable cannabis lender and enjoy favorable terms that give you the best opportunity to keep your business operations on track. Contact Details Canna Business Resources info@cannabusinessresources.com Company Website https://cannabusinessresources.com/

March 03, 2023 11:57 AM Eastern Standard Time

How Does Cannabis Real Estate Impact Local Cannabis Companies?

Canna Business Resources

Nearly nine out of 10 Americans say marijuana should be legal for medical and recreational use, according to the Pew Research Center. Now that the cannabis industry has grown in acceptance, business owners need to secure cannabis real estate to operate. At the same time, however, the lingering stigma makes it harder for business owners to obtain property. If you’re hoping to open a cannabis business in your area, this guide can orient you to the options and challenges of marijuana real estate. Types of Cannabis Real Estate The cannabis industry is surprisingly diverse. Your real estate needs may vary based on the type of business you’re operating. 1. Retail Space Retail space is needed for those who sell marijuana directly. Like other retail businesses, these properties should be chosen based on traffic, visibility and ease of access to ensure success. You’ll also want to ensure that your store layout is conducive to an enjoyable, frictionless customer experience. 2. Commercial Warehouses Warehouses are storage and linking points in the cannabis supply chain, so they may be operated by retailers directly, as well as producers and distributors. Warehouses should be selected based on proximity to their final destination and the source of their contents. 3. Rural Farmland Producers require sufficient acreage to grow marijuana. Because space is needed, this type of cannabis property will typically be found in rural locations, and buyers will need to ensure that the land offers good runoff, quality soil and favorable weather. Using a greenhouse gives you added security and can be used to cultivate plants in virtually any climate. 4. Commercial Plants Producers and distributors may rely on commercial plants to process marijuana crops and prepare them for final sale. These facilities commonly require sufficient square footage to handle inventory, personnel and equipment. Challenges for Cannabis Businesses Seeking Quality Real Estate Despite widespread acceptance of recreational marijuana, cannabis business owners still face significant hurdles when it comes to securing cannabis real estate. Here are some of the biggest challenges affecting the industry. Local Ordinances Even though cannabis businesses are legal, some local communities prohibit cannabis businesses from operating. For instance, 40% of Connecticut towns ban cannabis businesses, according to CT Insider. This factor forces business owners to pursue marijuana real estate in urban centers, which can raise prices and present stiff competition. Financing Hurdles Currently, most major banks and traditional financial institutions do not work with cannabis businesses. This issue can make it harder to obtain the financing needed to buy or lease a cannabis property in your community and may force you to rent a property until you build enough capital to fund your own real estate purchase. Fortunately, some lenders specialize in cannabis business loans, though entrepreneurs may find themselves facing limited options compared to other types of business. Strong Competition Now that recreational marijuana is legal in at least 21 U.S. states, entrepreneurs are scrambling to get in on the action. But since cannabis businesses are often localized in urban centers because of local ordinances, cannabis business owners may face strong competition, making it harder to gain traction in a crowded marketplace. Advantages of Diverse Real Estate Holdings for Cannabis Businesses Diversification is a sound investment strategy regardless of whether you’re talking about stocks, bonds or tangible assets, such as real estate property. Cannabis business owners can expect the following benefits when they pursue diverse real estate holdings — that is, owning multiple types of property. Mitigates Risk Having access to multiple properties can protect you from sudden economic changes. For instance, if you’re renting a retail space, and the landlord increases the monthly fee, you can shift your business to an alternate location to trim expenses. Presents Opportunity for Growth Operating in multiple locations gives you added business opportunities and room to grow. You may discover that one location offers the physical space you need to introduce a new piece of equipment or product line. Provides a Form of Passive Income Renting out your real estate property gives you a source of passive income. For instance, you might consider renting a portion of your warehouse space to another business to keep costs down. Considerations of Cannabis Real Estate Cannabis business owners have some special considerations relating to their real estate. Security Cannabis properties — including warehouses and fields — require security to protect your money as well as your inventory. When selecting a property, ensure the building and area can be secured to protect your assets and employees. Expansion Opportunities A retail storefront in a crowded location might not provide the physical space you need if you plan on expanding soon. When possible, try to select properties that give you room to grow. Ongoing Costs If you’re renting a property, you may face rising costs as landlords raise the cost of rent, which can put a damper on your cash flow and capacity for expansion. Even if you own the property, you’ll have to plan carefully to manage your tax liability, which will increase as your business grows. Give Yourself Room to Grow Choosing the right cannabis property is important since it affects business now and in the future. That’s why it’s important to select a property that fits your business goals and gives you room to expand your horizons as business improves. Contact Details Canna Business Resources info@cannabusinessresources.com Company Website https://cannabusinessresources.com/

March 03, 2023 11:51 AM Eastern Standard Time

What are Cannabis Lenders and How Do They Support Business Owners?

Canna Business Resources

Business owners are familiar with the ups and downs of cash flow. It’s common for companies to borrow money for supplies, payroll and other business needs. When cash flow is delayed, seasonal slow-downs occur or expansion is underway, businesses may need a boost. Business owners in the cannabis industry face an uphill battle when it comes to securing traditional loans. The good news is that your company can find needed financing through cannabis lenders. What are cannabis lenders, and why are they preferable to traditional lending institutions? What do you need to know before you take out a business loan? What Is a Cannabis Lender? Like traditional banks, cannabis lenders offer a range of financial resources, such as banking options, financing and processing solutions. The difference is that they cater specifically to the cannabis and CBD industries. In the past, cannabis companies have had little option but to run cash businesses and turn to predatory private lenders offering unfavorable terms. With increasing legalization and a growing market for cannabis goods, however, a new breed of lenders is bridging the gap by providing reliable funding and tools to help businesses increase efficiency and profit. What Makes Cannabis Lenders a Better Choice than Banks for Financing? Banks must comply with federal regulations and because cannabis has not been federally legalized, major banks won’t provide services like loans. They don’t want to wade through the risks and complexities, even for established businesses with proven profitability. Cannabis business loans from dedicated lenders, on the other hand, come with a range of benefits. These lenders understand your industry, offer specific types of financing and provide a range of favorable options. They make it much easier for established businesses to secure needed funding. 5 Things Cannabis Business Owners Need to Know About Cannabis Lenders Before you jump into a lending situation with the first company you come across, it’s important that you understand what lenders are looking for and what options are available to you. 1. What Cannabis Lenders Look For Like most lenders, cannabis lenders are looking for a safe and solid investment. At the end of the day, they want to work with reliable companies that pose minimal risks. In short, they want every assurance that they’ll get their money back. For this reason, they typically serve businesses that are already established and can provide a history of revenue. They’ll be interested in your industry experience and how long your current business has been operating. What you should look for is a lender that offers a range of options, including uncollateralized financing. 2. Multiple Lending Options Are Available In addition to typical loans, cannabis financing from a reputable lender should include a number of options to fulfill different business needs. You’ll want to look for institutions that offer lines of credit, working capital, accounts receivable invoice financing, real estate financing and equipment financing, as well as banking and processing solutions. Every business is unique, and the right lender understands this. It will help you find the lending options that suit your particular needs and preferences so that you have the best opportunity to thrive. 3. Deep Understanding of the Marijuana Industry Business owners often wear a lot of hats, but that doesn’t necessarily mean you have the knowledge or experience to excel at every aspect of business management. You will have to rely on a range of other professionals to help you with everything from contracts to tax filings to financing. Ideally, you’ll want to collaborate with professionals who understand your industry and your business. Cannabis lenders necessarily have a deep understanding of the marijuana industry, which gives them the insight to offer products most suited to your operation. This is a major benefit when you’re seeking financial assistance but are unsure of the best type of lending for your needs. 4. Tools and Resources Are Available When traditional banking and lending options are unavailable to you, it can be difficult to see a path forward for your business. Cannabis lenders provide the tools and resources you need to survive, thrive and expand your business. The right banking, processing and financing solutions can help you to better manage your operations, streamline cash flow and grow your company. 5. Flexible Financing Within the Cannabis Industry Working with traditional banks as a cannabis company is a complicated and frustrating process. The cannabis industry operates in a sort of limbo position because of the legal framework surrounding it. Dozens of states have legalized marijuana for medical or recreational purposes and others have decriminalized it. Hemp CBD is federally legal. However, cannabis, in general, remains illegal at the federal level. Banking institutions face high risks and legal complexities in serving the cannabis industry, so by and large, they don’t. To find flexible banking and lending options, cannabis companies must turn to a new class of lenders that focus specifically on cannabis clients. Is Cannabis Lending Right for You? If you are an established cannabis company searching for lending options that help you weather the ups and downs of cash flow or expand your operations, cannabis loans are the way to go. The right lender can provide financing resources designed specifically for your industry and the unique needs of your business. Contact Details Canna Business Resources info@cannabusinessresources.com Company Website https://cannabusinessresources.com/

March 03, 2023 11:45 AM Eastern Standard Time

Arizona Cannabis Loans and Financing Options

Canna Business Resources

In November 2020, Proposition 207, officially known as the Smart and Safe Act, passed into law in Arizona, making it the 15th state to legalize marijuana for adult use. Although recreational marijuana is legal in the state, it's still a challenge for cannabis business owners in Arizona to get financing. You likely won't get a business loan from a traditional bank because of federal regulations, but there are some options available if you need access to capital to expand your business. Because there's no one-size-fits-all approach for financing, it's important to understand all available options before you decide on financing. Is Cannabis legal in Arizona? Cannabis is legal in Arizona. Anyone over the age of 21 can possess up to an ounce of marijuana. They can legally walk into a dispensary with their ID and cash to purchase it — no prescription or referral is needed. Do Arizona Banks Lend Money to Cannabis Companies? Traditional banks don’t approve the majority of business loans to begin with, but the odds of financing for cannabis businesses are even lower. Despite many states approving cannabis use, it’s still illegal federally in the United States. Banks and financial institutions must abide by federal law, which makes it difficult for them to lend money to marijuana businesses. Because banks are regulated by the federal government, they are not allowed to engage in these types of transactions and can be subject to fines or even criminal charges if they do. What Are Some of the Key Factors to Consider When Looking for Cannabis Business Financing in Arizona? When it comes to securing financing for cannabis businesses in Arizona, there are several key factors that must be taken into consideration. An individual or business seeking cannabis business financing should research all potential lenders and investigate each lender’s requirements for loan qualification. Knowing the qualifications necessary before beginning the process can save time and money in the long run. Understanding what kind of financial documents will be required to properly apply for a loan is crucial. The most common documents requested include tax returns, bank statements, proof of income, a business plan and financial projections. Another important factor to consider when looking for cannabis business financing in Arizona is the cost of borrowing. Because the cannabis industry is relatively new, interest rates and repayment terms can vary widely among lenders. Researching available options and comparing rates is essential to determine which lender offers the lowest cost of borrowing. Investigate possible fees associated with obtaining a loan such as origination fees or application fees because these can significantly affect total costs over time. When exploring cannabis business financing opportunities in Arizona it is important to understand local regulations and restrictions. Depending on the specific type of cannabis product being produced or sold, certain licenses may be required from local governments or agencies to legally do business within the state. While some banks may offer loans for businesses operating within Arizona’s regulatory boundaries, some may not provide funds because of their own internal risk-management policies or because they do not wish to violate federal laws regulating marijuana use across state lines. 5 Types of Cannabis Loans for Arizona Business Owners Specialized lenders offer five basic types of cannabis loans in Arizona. Working Capital Working capital loans are ideal for businesses that need to secure additional capital for day-to-day operations. These types of loans can help businesses cover the cost of purchasing inventory, pay bills or manage cash flow. Working capital loans have flexible terms and repayment plans, making them an attractive option for businesses in the cannabis industry. When it comes to working capital loans, there are two main components: the principal loan amount and the interest rate. The amount of money available will depend on the size of your business and the repayment plan you agree to with your lender. AR Lines of Credit Another type of cannabis loan is an accounts receivable (AR) line of credit (LOC), which is best suited for businesses that are seeking financial assistance during slow periods in sales or when faced with unexpected expenses. An AR LOC acts like a revolving line of credit where businesses can draw upon their eligible receivables, such as invoices they have sent to customers, whenever they need additional funds. When customers pay those invoices, those amounts get credited back against their LOC balance, allowing them to draw down new funds if needed. As with any other type of business loan, borrowers should carefully read through all terms and conditions with lenders before entering into an agreement. Equipment Financing Cannabis equipment financing loans are specifically designed to help businesses in the cannabis industry acquire the necessary equipment for their operations. This type of loan typically has a shorter repayment term than traditional bank loans and is ideal for businesses that need short-term financing. The funds from a cannabis equipment financing loan can be used to purchase anything from computer systems and point-of-sale systems to grow lights and cultivation supplies. Commercial Real Estate Investing Commercial real estate investing for cannabis financing is another way for cannabis companies to obtain needed capital. Through this investment model, investors purchase properties or provide capital in exchange for either equity or debt in the cannabis company. Investors may also provide funding directly to the commercial real estate owner as a bridge loan or hard money loan. This investment option allows businesses to access funds without having to take on additional debt or give up ownership in their business. Real estate investments offer investors more security than other forms of investing because they are secured by physical assets such as land, buildings and other physical property. For example, if the tenant defaults on their lease payments, the investor will still receive rental income from other tenants until the matter is resolved. Cannabis companies may also use commercial real estate investments as a source of long-term capital to fund expansion projects and acquisitions. By investing in an undervalued building or property with the potential for higher value appreciation, businesses can leverage these assets for greater returns over time. Cannabis Dispensary Loans Cannabis dispensary loans are a type of financing specifically designed to help cannabis businesses fund their operations. This type of loan is becoming increasingly popular as the marijuana industry continues to grow and evolve. This specialty loan is available to marijuana-related businesses, such as dispensaries, cultivators, processors and manufacturers who are in need of funds for various business activities, including purchasing supplies, hiring employees or expanding operations. Generally, cannabis dispensary loans are short-term options that can range from $50,000 to $1 million. Depending on the lender’s qualifications and criteria for approval, the amount of money lent can be higher than this range. The majority of cannabis dispensary loans have repayment periods ranging from two months up to 36 months. Benefits of Expanding Your Arizona Cannabis Business Marijuana sales soared in 2021, just one year after it became legal for recreational use. Arizona is second in sales only to California. Demand for the product is huge, making it the prime time to scale your cannabis business. As an established business, you’re already a trusted name in the industry. Expanding into new markets can help you tap into new customer bases and increase your overall revenue. A Specialized Lender for Reliable Business Growth A business loan from a specialized cannabis lender gives you the opportunity to obtain the financing you need to expand your business and the assurance they know the industry inside and out. You won’t have to worry about being taken advantage of or navigating the legal red tape. These experts can guide you through the entire process and explore the various options to help you grow. Contact Details Canna Business Resources info@cannabusinessresources.com Company Website https://cannabusinessresources.com/

March 03, 2023 11:37 AM Eastern Standard Time

News Release

Nextleaf Solutions results reveal Glacial Gold as #1 CBD vape in British Columbia

Nextleaf Solutions Ltd

Nextleaf Solutions CEO Paul Pedersen joined Steve Darling from Proactive to share news the company has released its first-quarter financial statements showing revenue increasing of 24% from 1Q last year. Pedersen told Proactive this was helped by the success of Glacial Gold which is the #1 selling brand of CBD vapes in British Columbia with a market share of over 39%. The company was also able to generated positive cashflow from operations. Contact Details Proactive Canada +1 604-688-8158 na-editorial@proactiveinvestors.com

March 03, 2023 11:33 AM Eastern Standard Time

Video

RespireRx Pharmaceuticals subsidiary ResolutionRX signs on iNGENu as CRO for dronabinol development

RespireRx Pharmaceuticals

RespireRX Pharmaceuticals chief financial officer Jeff Margolis joins Proactive's Natalie Stoberman with the news that subsidiary ResolutionRX has announced a services agreement with Australian contract research organization (CRO) iNGENu. Margolis said iNGENu will act as a full-service CRO in support of ResolutionRx’s research and development program, which is developing a proprietary formulation of dronabinol for the treatment of obstructive sleep apnea and anorexia. Contact Details Proactive United States +1 347-449-0879 action@proactiveinvestors.com

March 03, 2023 11:14 AM Eastern Standard Time

Video

RenovoRX's Latest Innovative Technology Creates New Hope For Chemotherapy Patients

TalkMarkets

Introduction Wouldn’t it be nice if there was a way to increase the doses of chemotherapy to the tumor whilst at the same time reducing the dose for the rest of the body? This would be an ideal way to reduce its horrible side effects? Well, RenovoRx ( RNXT ) has actually developed such a technology that it plans to use for solid tumors that are difficult to treat because they have no veins feeding them. Their patented innovative drug delivery system called RenovoCath uses pressure to deliver chemotherapy agents to reach difficult-to-reach tumors by pressuring them through the walls of a nearby vein. Doing so enables concentrating chemotherapy in otherwise difficult-to-reach tumors, increasing both the efficacy and lessening the side effects of chemotherapeutic agents. The company has two clinical trials ongoing, a phase 3 trial for pancreatic cancer and a phase 2 / 3 trial for duct bile cancer. Company Overview: Phase 3 Lead Drig Product Candidate: RenovoGem Intra-arterial gemcitabine (chemotherapy) delivered through FDA cleared RenovoCath delivery system Phase 1, 2 and observational registry trial data demonstrated efficacy signals Phase 3 interim analysis based on patient deaths – estimated Q4 ’22 / Q1 ‘23 Targeted Approach: designed to decrease side effects and increase penetration Reduced systemic drug exposure compared to systemic chemotherapy) Higher local drug concentration Novel Therapy Platform: RenovoTAMP Trans-Arterial Micro-Perfusion compatible with multiple small molecule chemotherapy drugs Broadly applicable to locally advanced solid tumors Initial indications: pancreatic cancer ($1B addressable market) and cholangiocarcinoma) Potential future indications include non-small cell lung cancer, uterine tumors, glioblastoma RenovoTAMP Platform: layers of market exclusivity (regulatory and IP) Orphan Drug Designation provides 7 years of market exclusivity for RenovoGem upon NDA approval 7 US patents issued on RenovoTAMP, delivery system, and drug/device combination RenovoTAMP Most solid tumors are easily reachable for chemotherapeutic agents as they have plenty of feeding blood vessels going directly into them: However, there are solid tumors (like pancreatic cancer, duct bile cancer, locally advanced lung cancer, locally advanced uterine tumors, and glioblastoma) that often lack such a direct connection to blood vessels. This makes these tumors difficult to reach with chemotherapy agents, the alternative is ( S-1 registration ): "Trans-arterial chemoembolization (TACE) is an established first-line therapy for certain solid tumors. A key component of this approach is to identify and isolate vessels feeding the tumor, known as tumor feeders. However, in patients with pancreatic cancer, no tumor feeder vessels are visible during angiography. In the absence of visible tumor feeders, we can introduce drugs directly across the arterial wall into the surrounding tissue via pressurized diffusion." Enter RenovoTAMP, their patented drug delivery system, which isolates nearby vessels and uses pressure in these to force the drug into the tumor. How does that work? Here are the mechanics, from the S-1 registration: "Our RenovoTAMP platform therapy utilizes pressure-mediated delivery of gemcitabine across the arterial wall to bathe the pancreatic tumor tissue in 120mL of saline with 1,000mg/m2 of the drug over a 20-minute delivery time (approximately a total of 1,500-2,000mg of drug dependent upon patient Body Surface Area). RenovoCath is an adjustable double balloon catheter designed to isolate the proximal and distal vessel and adjust the distance between the balloons to exclude any branching blood vessel offshoots." The platform has a number of advantages, from the S-1 registration: Application of Approved Small Molecule Chemotherapeutic Agents: We use approved small molecule chemotherapeutic agents such as gemcitabine. Targeted Approach: With our approach, we have demonstrated in our clinical studies up to 100 times higher local drug concentration compared to systemic chemotherapy. We believe our approach decreases systemic exposure and improves patient outcomes. Delivery Method Independent of Tumor Vascularity: We invented a novel combination platform and delivery system to deliver small molecule chemotherapeutic agents in solid tumors resistant to systemic chemotherapy due to a lack of tumor blood vessels or tumor feeders. Broad Application for Solid Tumor Indications: Our platform is not restricted to a single small molecule chemotherapeutic agent or solid tumor type. As such, our platform and delivery system may be applied for use in additional solid tumor indications, including in solid tumors without identifiable tumor feeders. Pipeline The company has five conditions in its pipeline, two of which are in the clinical phase: Pancreatic Cancer: Phase 3 TIGer Study (Q4 ’22 / Q1 ’23 Interim, Analysis, ’23 Enrollment Completion, 2H ’25 Data Read Out) Bile Duct Cancer (Cholangiocarcinoma): Phase 2 CouGAr Study Lunch Cancer: Pilot Animal Study Completed Uterine Tumors Glioblastoma First and Second Indications: Locally Advanced Pancreatic Cancer and Hilar Cholangiocarcinoma First Indication: Pancreatic Cancer (Orhpan Designation) One of the deadliest cancers, with poor outcomes Pancreatic cancer is expected to quickly become the second leading cause of cancer related deaths 5-year overall survival rate of 5-10% (Stages I-IV) In 2021 it was estimated that 60,000+ Americans were diagnosed with pancreatic cancer More than 48,000 died of the disease Approximately 30% of patients have locally advanced pancreatic cancer (LAPC) and are not candidates for Surgery Current Standard of Care Gemcitabine with Abraxane was approved in 2013 based on an 8-week survival benefit LAPC has approximately 12-15 month median survival Second Indication: Hilar Cholangiocarcinoma (HCCA), Bile Duct Cancer (Orphan Designation) Cholangiocarcinoma (CCA) is a disease with an exceptionally poor prognosis CCA is the second most common primary malignant tumor of the liver with over 7,000 new cases diagnosed annually in the US. Based on the tumor location, CCA is defined as either intra-hepatic (within the liver) or extra hepatic (hilar cholangiocarcinoma, or HCCA) Current Standard of Care Due to toxicity of the standard of care, a practice standard of care has not been established for HCCA Gemcitabine wiith cisplatin used in ABC-2 clinical trial LAPC; Pancreatic cancer with RenovoGem The most advanced is the company’s treatment for LAPC or locally advanced pancreatic cancer, with RenovoGem, which is a combination of an existing chemotherapy agent gemcitabine delivered via RenovoCath, the company’s patented delivery system. RenovoRX Employs De-Risked Small Molecule Chemotherapy Drugs First Drug Candidate: Intra-Arterial Gemcitabine IV (systemic) gemcitabine marketed in the US since 1996 Established as part of a current standard of case for pancreatic cancer and other solid tumors Potent anti-tumor agent: cell phase specificity primarily killing cells undergoing DNA synthesis (S-phase) Pre-clinical studies: inhibits 80-100% of tumor growth with subsequent increases in lifespan Limitations of IV/systemic delivery include poor tumor tissue penetration and high systemic toxicity RenovoGem (Intra-arterial Gemcitabine + RenovoCath) Intra-arterial gemcitabine for treatment of solid tumors FDA Orphan Drug Designation (7 years marketing exclusivity post-approval) for pancreatic cancer and CCA) Phase 1 / 2 and observational registry trial data demonstrated an increase in overall survival time in patients with LAPC Median survival of 27.9 months) including radiation pre-treatment) vs. 12-15 months historical control Phase 3 interim analysis expected in Q3 ‘23 Mid-previous decade, the company held two clinical trials for RenovoGem: Results: Phase 1 and II Clinical Trials To date, 43 patients treated with Intra-Arterial Gemcitabine using RenovoCath between the 2 studies from May 2015 to Dec 2018 Average age of patient enrolled was 69.9 years Median gemcitabine dose was 1000mg/m 2 Full 1000mg/m 2 dose administered to 33 of the 43 patient cohort On average, each patient received four intra-arterial treatments, ranging from 1-14 treatments 13 of 43 patients completed the planned 8 treatments of IA therapy Reasons for early discontinuation of IA therapy: Tumor progression (n=12) Patient/Physician preference (n=8) Serious adverse events (n=6) Others (n=4) RR1 a phase 1 / 2 safety trial with 20 patients establishing a maximum dose of 1000mg/m 2 of intra-arterial gemcitabine delivered via RenovoCath RR2 Observational study produced a 29% survival (versus 12% for chemo) after 2 years. It has to be said that these were not double-blind studies; the comparison in RR2 is made with an average based on historical data. TIGeR-PaC Randomized Clinical Trial - Phase 3 Multicenter Trial Trans (Intra-arterial Gemcitabine vs. Continuation of IV Gemcitabine and Nab-Paclitaxel following Radiotherapy for Locally Advanced Pancreatic Cancer (TIGeR-PaC) Randomized Clinical trial) Prospective multicenter randomized clinical Trial evaluating systemic therapy versus intra-arterial gemcitabine for pancreatic cancer Primary Objective: Overall Survival from time of randomization Secondary Objectives: PFS, objective response rate, duration of response, HR-QOL, degree of peripheral neuropathy, incidence of neutropenia, tolerability, and safety Inclusion Criteria: Histologically confirmed pancreatic adenocarcinoma with initial diagnosis within 6 weeks of consent Locally advanced, unresectable disease, as defined by NCCN Guidelines ECOG 0-1 These were encouraging results so they are now continuing with a phase 3 trial called TIGeR-PaC. The phase 3 TIGeR-PaC trial has run into some delays though after the company modified its SAP (statistical analysis plan) which it submitted to the FDA in June 2022. The main changes (from the 10-Q ): (i) analyze only patients receiving SBRT, consistent with the protocol change made in December 2021, (ii) include a second interim analysis, (iii) change the total number of SBRT patients randomized in the study to 114 (a reduction from the original 200 patients) with a total of 86 deaths from SBRT patients, including all deaths from SBRT patients enrolled in the study before the submission of the Modified SAP, and (iv) repower the study from 90% to 80%, which is commonly used in clinical trials. Originally they were also including IMRT patients but these had a higher dropout rate during the induction phase. In my discussions with RenovoRX CEO Shaun Bagai, he shared that management believes this will shorten the timeframe and significantly reduce costs. The FDA has not yet signed off on the revised SAP though, in fact, they have not yet submitted the revised SAP, which will occur in Q1/23. The first interim results will occur when 30% (26 of 86) of the total number of deaths have occurred and the second interim analysis will be at 60% (52 of 86). On November 14 they had 37 SBRT patients with 114 in total needed, at this rate they expect all patients to be enrolled and randomized in 2025 with the final results out in 2025. But before that happens we get the interim results. eCCA or extrahepatic cholangiocarcinoma The company’s second condition for treatment with RenovoGem is eCCA or extrahepatic (or outside the liver) cholangiocarcinoma, cancer that occurs in the bile ducts. There is already a significant amount of pre-clinical data supporting its effectiveness against this condition. The company is putting together a phase 2/3 trial treating eCCA with RenovoGem and has already submitted the protocol to the FDA. Without any objection from the FDA, patients can start enrolling in Q1/23. Market Opportunity There is a $1 billion locally advanced pancreatic cancer market opportunity. $500 million in the US, and $500 million internationally, with an average new oncology drug pricing of $150,000 per year. (Source: Fletcher Spaght, 2019). There will be a prospective/formal pricing analysis conducted with Phase 3 data prior to commercial launch of RenovoGem. This is for pancreatic cancer alone RenovoGem gained an ODD or orphan drug designation from the FDA in 2018 for pancreatic cancer and for HCCA (bile duct cancer) in April 2021. ODD provides the company with seven years of exclusivity to market intra-arterial use of gemcitabine for LAPC and ACCA upon New Drug Application, or NDA, approval. Finances The company is not generating revenues and won’t be for quite some time so cash burn is a prime indicator to assess. There is not a lot of room here as they had $8.1M at the end of Q3 after they pocketed a net $14.6M with their IPO in August 2021. Their GAAP OpEx was $2.1M in Q3 and they lost $7.1M in operational cash flow YTD. Management expects expenses to increase substantially as a result of the clinical trials, hiring additional research, development, engineering people and SG&A expenses, and defending their IP. There are also 1.2M outstanding performance options, and 2.8M warrants (although with an exercise price of $10.8, they are far out of the money), so that’s 13M shares at $2.7 for a market cap of $35.1M or an EV of $27M. We’re pretty sure that if the company becomes successful with at least one FDA-approved application for RenovoGem, but keep in mind this is a platform technology with potentially multiple use cases (not to mention it’s not necessarily limited to gemcitabine, the chemical therapy agent they’re using so far). But we’re not there yet and won’t be for some time, 2025 at the earliest. Before that, they will have to go back to the financial markets and/or find a partner to help them with the clinical trial cost. Conclusion RenovoRx takes existing chemotherapies and makes them more effective and less invasive at the same time, by being able to concentrate most of the chemotherapy agent on the tumor itself, rather than letting it loose in the whole body. All this with the help of its patented RenovoTAMP platform. This is especially useful for tumors that don’t have feeders, and veins that go directly into the tumor, which is often the case with pancreatic cancer and bile duct cancer, the first two conditions the company is targeting with clinical trials. Early results are promising, and the company received orphan drug designations for both conditions. But as always this isn’t guaranteed until phase 3 trials are concluded successfully and RenovoGem gets final regulatory approval. This isn’t imminent, it will be 2025 at the earliest and until then the company will need additional financing and/or a partner with deeper pockets. However, there are two things that make the situation interesting for investors: The company’s core technology can be used in multiple conditions, greatly enhancing its potential commercial value. The market cap is a fraction of what the company could be worth when they get final FDA approval. Originally published on TalkMarkets. More By This Author: 7 Reasons Why SurgePays Is Going To Surge Protalix BioTherapeutics Well Placed to Advance in 2023 SOBRSafe: A Very Favorable Risk/Reward Play Disclosure: The author has no position in any stocks mentioned. Additional Disclosure: This article is part of a new “UnderCovered” series of exclusive articles featuring companies with limited coverage. Authors are compensated by TalkMarkets for their time, and otherwise represent their own assessments and opinions. Authors are not compensated by the subject companies in any way. This article is also part of our IR Insights Initiative in which articles about participating companies can receive greater visibility. To learn more click here. Contact Details TalkMarkets www.TalkMarkets.com ir@talkmarkets.com

March 03, 2023 10:00 AM Eastern Standard Time

The Silent Killer: The Impact Of Kidney Disease On Patients And Their Caregivers

Unicycive Therapeutics, Inc.

By Julian Richard, Benzinga Unicycive Therapeutics Inc (NASDAQ: UNCY) is a biopharmaceutical company committed to developing effective and safe treatments for kidney (renal) disease to reduce death rates and improve patients and their caregivers' quality of life by combining cutting-edge research with innovative products and services, Unicycive Therapeutics Inc. works toward providing transformative treatments to fight acute and chronic diseases. Through its groundbreaking research and innovative treatments, Unicycive Therapeutics is spearheading the charge to bring renewed hope to countless patients worldwide. Two lead compounds are the subject of clinical development: Renazorb™. an investigational treatment for increased phosphorus in the blood (hyperphosphatemia) in those with chronic kidney disease (CKD) on dialysis, and UNI-494, for the treatment of acute kidney injury. Silent And Insidious Chronic kidney disease is a serious, life-threatening condition that affects countless people worldwide. It has emerged as one of the leading causes of death globally and is one of only a handful of non-communicable diseases to have i ncreased mortality over the past two decades. Unfortunately, kidney disease often goes undetected until there is significant kidney damage, resulting in end-stage renal disease and death. This makes it all the more important for patients and their carers to understand this silent killer's signs, symptoms and consequences. The disease can be debilitating and have devastating effects on those affected. Consequently, CDK causes a profound decrease in the quality of life of patients. Patients suffering from advanced CKD may experience fatigue, nausea, swelling in the hands and feet, high blood pressure, changes in urine color or amount and a build-up of toxins in the blood (uremia). In severe cases, these symptoms can lead to an inability to work or function normally, which can cause further physical and emotional stress. In addition to the physical, emotional and financial impact of kidney disease, there is also a social impact. Those suffering from kidney disease may be unable to participate in activities they once enjoyed due to fatigue or other symptoms. They may also find it challenging to interact socially with friends and family because of their condition and low self-esteem. For caregivers of those suffering from kidney disease, the impact can profoundly affect their physical and emotional well-being. They may be required to manage physical and emotional symptoms that are difficult to understand or predict and manage treatments ranging from dialysis to dietary changes. Caregivers must also understand medication regimens and any potential side effects to ensure their loved one's safety while managing the condition. Those affected by CKD and their caregivers must understand the seriousness of this condition to take steps towards preventing it, managing it effectively, and finding support if needed. Awareness of the signs and symptoms of kidney disease can help patients identify the issue before damage occurs, while access to treatments can ensure that complications are prevented or managed appropriately. Visit https://unicycive.com for more information on the company and its product candidates. This article was originally published on Benzinga here. Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug, Renazorb, is a novel phosphate binding agent being developed for the treatment of hyperphosphatemia. UNI-494 is a patent-protected new chemical entity in late preclinical development for the treatment of acute kidney injury. This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Anne Marie Fields - Stern Investor Relations +1 212-362-1200 annemarie.fields@sternir.com Company Website https://unicycive.com/

March 03, 2023 09:15 AM Eastern Standard Time

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The Silent Killer: The Impact Of Kidney Disease On Patients And Their Caregivers