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This Company Is Focused on Treg-Enhancing Therapies - Could This Be Medicine’s Next Frontier?

Coya Therapeutics Inc.

By David Willey, Benzinga Texas-based biotech company, Coya Therapeutics (NASDAQ: COYA), is positioning itself as a leader in a promising area of the medical field. When the father of company CEO and founder Howard Berman was diagnosed with dementia, Berman became inspired to turn his expertise in neuroscience towards developing a treatment that could help his father and others like him. Now the company has conducted trials that show the promise of a new therapy to slow or stop neurodegenerative diseases like Parkinsons, Alzehimers, and Amyotrophic Lateral Sclerosis (ALS), as well as other autoimmune and metabolic diseases. Cell and gene therapy (CGT) is a growing biomed market. It is currently worth over $18 billion and was forecasted to grow at a compound annual growth rate (CAGR) of 22.41% by Precedence Research, bringing its value to over $93 billion by 2030. Regulatory T cell (Treg) therapy is a developing field in the cell therapy market. It has been inspired by the successes of Chimeric antigen receptor (CAR)-T cell therapies for treating cancer. CAR-T treatments, which engineer the immune system to respond to the cancerous cells, have seen high complete remission rates in cancer patients suffering from cancers like B-cell acute lymphoblastic leukemia (B-ALL). Treg-based therapies look to apply the innovations of CAR-T therapy to other diseases. It's an exciting field, with around $3 billion raised by investors over the past decade. More than 180 trials for Treg therapy have been registered in the past twenty years, however the majority of these trials are still pre-clinical. While many companies involved in Treg-based therapy remain in the pre-clinical stage, one is already bringing data to the table. Coya Therapeutics is advancing multiple Treg-based therapy modalities and is one of the most clinically advanced companies in the Treg field. Coya Is Tackling Inflammation At Its Source Many neurodegenerative diseases, including ALS and Parkinson's Disease, are often driven by widespread inflammation, resulting from a malfunction of Treg cells. Coya Therapeutics is investigating Treg’s potential for reducing inflammation by modifying the Treg cell to make it functional again and down-regulate the cytokine inflammation. The company believes that restoring Treg cells’ functionality could either slow or stop the spread of these diseases. Unlike some others in the market, Coya has been able to bring its therapies to the clinic. With its Coya-101 therapy, it has validated this approach for cell therapy, with two trials that either slowed or stopped the disease’s progression. With its Coya 302 therapy, it is also looking to add biologics to its portfolio. In two proof of concept studies, the company has identified two biologics which treat Alzheimers and ALS, and biomarkers indicate patients seeing some recovery for the disease. Also biologic treatments, which are derived from living organisms as opposed to synthetic chemicals, have the advantage of being both cheaper and more scalable than traditional treatments. Biologics can be developed as “off the shelf” therapies, as opposed to the more time-consuming autologous treatments that are specific to each patient. Other companies working in the TREG space include Sonoma Biotherapeutics, which has received investment from the venture arm of Eli Lilly and Company (NYSE: LLY), GentiBio, which has seen investment from the venture arm of Novartis (NYSE: NVS), and Abata Therapeutics. Treg-based therapies are a unique way to target inflammation and potentially reverse the spread of the disease at the cellular level. Currently there are only two FDA-approved drugs on the market to treat ALS and Frontotemporal dementia (FTD), and they don’t seem to halt the disease. While studies have sought to reduce inflammation in ALS patients using drugs like cyclooxygenase–2, or through experimental therapies that use intracerebral and intrathecal delivery, these approaches are either too invasive or don’t appear to reduce inflammation. Coya believes its novel cell therapy could see positive results, just as CAR-T treatment saw cancer remission rates without the negative side effects of treatments like chemotherapy. Want to learn more about Coya Therapeutics and its Treg therapies? Visit its website. This article was originally published on Benzinga here. About Coya Therapeutics, Inc.Headquartered in Houston, TX, Coya Therapeutics, Inc. (Nasdaq: COYA) is a clinical-stage biotechnology company developing proprietary treatments focused on the biology and potential therapeutic advantages of regulatory T cells (“Tregs”) to target systemic inflammation and neuroinflammation. Dysfunctional Tregs underlie numerous conditions including neurodegenerative, metabolic, and autoimmune diseases, and this cellular dysfunction may lead to a sustained inflammation and oxidative stress resulting in lack of homeostasis of the immune system. Coya’s investigational product candidate pipeline leverages multiple therapeutic modalities aimed at restoring the anti-inflammatory and immunomodulatory functions of Tregs. Coya’s therapeutic platforms include Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy. Coya’s 300 Series product candidates, COYA 301 and COYA 302, are biologic therapies intended to enhance Treg function and expand Treg numbers. COYA 301 is a cytokine biologic for subcutaneous administration intended to enhance Treg function and expand Treg numbers in vivo, and COYA 302 is a biologic combination for subcutaneous and/or intravenous administration intended to enhance Treg function while depleting T effector function and activated macrophages. These two mechanisms may be additive or synergistic in suppressing inflammation. This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investing advice Contact Details David S. Snyder David@coyatherapeutics.com Company Website https://coyatherapeutics.com/

March 06, 2023 09:00 AM Eastern Standard Time

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

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

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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

Branded Legacy, Inc.'s Subsidiary Alpha Growers Adds 4 Acres to its Farm, Expands Product Line and Gains New Wholesale Partners

BRANDED LEGACY INC.

McapMediaWire -- Branded Legacy, Inc. (OTC: BLEG ), a holding company that specializes in growth through acquisitions with a focus in the CBD industry is pleased to announce its subsidiary Alpha Growers, LLC has moved its farm to a new location, adding an additional 4 acres to its capacity. The move and expansion will allow Alpha Growers to increase its production of boutique flower and add wholesale pre rolls to its product line. "We're excited to be expanding our capacity and product line," said Jermain Strong, CEO of Branded Legacy, Inc. "Our new location will allow us to better serve our customers and meet the growing demand for high-quality hemp products." In addition to its expanded capacity and product line, Alpha Growers will continue its tradition of offering a hemp beer on 4/20. Details about the event will be announced soon. "We're looking forward to celebrating 4/20 with our customers again this year," said Strong. "It's always a great opportunity to showcase our products and connect with our community." Alpha Growers also announced that it has added three new wholesale customers to its roster, further expanding its reach and distribution capabilities. "We're thrilled to be partnering with these new wholesale customers and look forward to building long-term relationships with them," concluded Strong. "It's an exciting time for Alpha Growers, and we're grateful for the support of our customers and partners." About Spikes CBDX: Spikes CBDX is a line of CBD products designed to assist athletes perform better and recover faster. The Company believes that post workout recovery, with Spikes CBDX products, can lower inflammation, aid in making your body stronger, and help recover from injuries naturally. The CBD line also targets individuals who are looking for pain relief, better sleep, faster recovery and lowering inflammation. Spikes CBDX provides tinctures, lotions, moisturizer, and cryo-gel roll-ons. To view all the Spikes CBDX products please visit: spikescbdx.com. About Elev8 Hemp: Elev8 Hemp's mission is simple: craft the highest-quality, organic hemp products for consumers in search of a healthier, happier lifestyle. Everyone needs to get the proper amount of healthy proteins to keep them feeling better and more energetic. We source only the best organic hemp protein powders—naturally full of powerhouse amino acids and Omegas-3, 6, and 9—so we can infuse your daily coffee and tea with an abundance of minerals, vitamins, antioxidants and fiber. Mother Nature creates this pure hemp with a rare, perfect balance for optimal nutrition and exceptional taste. Elev8 Hemp takes these raw, natural products and transforms them into delicious CBD-infused beverages that will become your new favorite daily drink. CBD-infused coffees and teas are our specialty, and we take our mission very seriously. Let us do what we do best and let achieving a healthier lifestyle be as simple as remembering your morning cup. About Versatile Industries: Versatile Industries, LLC is an acquisition company used to incubate companies to eventually spin off into their own public vehicles. About Alpha Growers, LLC: Alpha Growers, LLC is a hemp farm in Newberry, FL. They grow and sell hemp flower, providing some of the highest quality plants in the industry. Its current operations are under Kamino Propagation and Research, LLC. Currently Alpha Growers has $320,000 in assets and is in contract to purchase the remaining assets of Kamino over the next few years. About Total Refinement Solutions, LLC: Total Refinement Solutions, LLC has developed no less than four potential standard operating procedures for extraction, refinement and synthesis of any given target alkaloid. It has secured inputs of raw plant material, crude extracts for refinement and a demand for the output. The Company currently has operational labware as assets. Safe Harbor Statement: The information posted in this release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify these statements by the use of the words "may," "will," "should," "plans," "expects," "anticipates," "continue," "estimate," "project," "intend," and similar expressions. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected or anticipated. These risks and uncertainties include, but are not limited to, general economic and business conditions, effects of continued geopolitical unrest and regional conflicts, competition, changes in technology and methods of marketing, delays in completing various engineering and manufacturing programs, changes in customer order patterns, changes in product mix, continued success in technological advances and delivering technological innovations, shortages in components, production delays due to performance quality issues with outsourced components, and various other factors beyond the Company's control. www.brandedlegacy.com (407) 337-0642 info@brandedlegacy.com Contact Details Branded Legacy, Inc. info@brandedlegacy.com

March 02, 2023 09:09 AM Eastern Standard Time

Poolbeg Pharma "couldn't be happier" with POLB 001 human challenge trial data

Poolbeg Pharma PLC

Poolbeg Pharma PLC (AIM:POLB, OTCQB:POLBF) CEO Jeremy Skillington speaks to Proactive's Thomas Warner after announcing the data readout from an LPS human challenge trial for POLB 001, the infectious disease focused biopharma company's lead molecule. Skillington says that he "couldn't be happier" with the results, that he says will help "ramp up the discussions" with potential partners. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

March 02, 2023 05:59 AM Eastern Standard Time

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Oncimmune investment "will continue to pay dividends"

Oncimmune Holdings PLC

Oncimmune Holdings PLC (AIM:ONC) CEO Adam Hill talks to Proactive's Thomas Warner after publishing full year results for the fifteen months to the end of August 2022. Hill gives his take on how the business performed during and after the reporting period, saying that investment undertaken "will continue to pay dividends." He also reveals his objectives for the rest of this calendar year. Contact Details Proactive UK Ltd Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

March 02, 2023 05:53 AM Eastern Standard Time

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Chronic Cluster Headaches No More: The Promise Of Lobe Sciences' At-Home Psychedelic Treatments Without The Trip!

Lobe Sciences

By Richard Dal Monte As early as the 1950s, scientists were researching the possible therapeutic benefits of psychedelics such as LSD and psilocybin mushrooms. But by the late 1960s, when the counterculture looked to psychedelics to turn on, tune in and drop out, those substances had earned a bad name, and that set back scientific exploration into their possible constructive uses for decades. More recently, however, scientists affiliated with universities and biotechnology companies have been examining anew the healing potential of psychedelics with an eye to treating everything from mental illnesses to strokes. One such company is Lobe Sciences Ltd. (CSE: LOBE | OTC QB: LOBEF), which is working on new compounds that could be used at sub-hallucinogenic levels to address severe anxiety in children as well as provide relief for sufferers of chronic cluster headaches — so devastating they’re also known as “suicide headaches” — and treat them at home with a prescription. A clinical-stage drug development biotechnology company focused on transforming psychedelic medicine to benefit neurological health in patients of all ages. Lobe Sciences is looking to take a bite out of a psychedelic drug market that is estimated to reach USD$10.35 billion by 2028. Lobe’s current focus is on two of its proprietary, patent-pending psilocin compounds, known as L-130 and L-131, which are slated for multiple Phase 1 and 2 human trials in 2023. Psilocin is the key for Lobe Sciences Dr. Fred Sancilio of Clearway Global, which is conducting clinical trials of L-130, says “there have been studies of much higher doses of psilocybin, which converts to psilocin in the body, that have showed success in treatment. But those hallucinogenic doses require a patient to remain in a sedate environment under a doctor’s supervision and can have a prolonged effect on the recipient.” Additionally, he notes that “the conversion of psilocybin to psilocin varies from patient to patient depending on each individual’s metabolism and even what they ate on the day they received treatment.” By developing psilocin as a stable single entity, says Sancilio, who’s also a Research Professor in the Department of Chemistry and Biotechnology at Florida Atlantic University, “we’ve bypassed both the enzymatic conversion in the GI tract and we’ve enhanced the bioavailability. So, psilocin would be the ideal drug to treat the neurological diseases.” “We are the only company that has psilocin as a single entity,” says Lobe’s Chief Scientific Officer, Maghsoud Dariani. “We believe the medication by itself is going to be effective and we are pursuing a sub-psychedelic dose, which would be much like any other drug: The doctor prescribes the medication and the patient takes it at home because there is no psychedelic trip involved.” Dariani says “the company believes this will not only be successful medically but, also, that the product will be viable commercially.” He also notes that “Lobe Sciences is seeking orphan drug designations for L-130 and L-131.” The U.S. National Cancer Institute defines an orphan drug as one that’s used to treat or prevent an orphan disease and explains an orphan disease is a rare, serious and often life-threatening disease that affects fewer than 200,000 people in the U.S. (For instance, fewer than 100,000 people suffer from chronic cluster headaches and there is no approved therapeutic approach). The Orphan Drug Act gives drug companies financial benefits for developing orphan drugs and grants seven-year market exclusivity to drugs that treat rare diseases. Regulatory Hurdles are Falling Sancilio points out that “products derived from mushrooms are already legal in a number of U.S. states” and Phil Young, Chairman and CEO of Lobe Sciences says “while psilocin and related substances may be designated a Schedule 1 drug for now — and lumped in that category with heroin and ecstasy — a bill has been introduced in Congress to move them down to Schedule 3 because they’re non-addictive and non-toxic, and have medical potential.” “Such a regulatory change would be a huge positive for Lobe’s business, as will the indications that L-130 and L-131 are being developed for and which can be prescribed for at-home use like all other prescription drugs,” Young says. “Phase 1 human testing will kick off early this year, with Phase 2 to follow later in 2023,” Young says. The company in January announced it has partnered with Dr. Lauren Natbony and Integrative Headache Medicine of New York to study the tolerability and efficacy of L-130 in patients suffering from chronic cluster headaches and is also working with researchers in Australia on further trials. Sancilio added that “ Lobe Sciences has several human clinical trials contracted with a global network of contract research organizations. The company intends to report data on these trials in the coming months.” With Lobe Sciences poised to make big strides in research — and having recently built a partnership with an API manufacturer — CEO Young says “he expects the company to be attractive to investors, especially as share prices have recently been in the single digits.” “For an investor, it’s a very straightforward story,” he says. “We have good science, we have good indications with unmet medical needs, we have every indication that the drugs are going to work. And now, for us, it’s an execution play. We just have to go out and do it, and that’s what we’re doing.” Learn more about Lobe Sciences Ltd. on its website as well as: Facebook Instagram Twitter LinkedIn This article originally appeared on Benzinga here. Lobe Sciences is a biopharmaceutical company focused on developing patient-friendly, practical psychedelic medicines. The Company, through collaborations with industry-leading partners, is engaged in drug research and development using sub-hallucinatory doses of our proprietary compounds for multiple Orphan Diseases. Each of our New Chemical Entities, L-130 and L-131, are being developed to address unmet medical needs in patients suffering from Chronic Cluster Headaches and a Confidential pediatric This news release contains forward-looking statements relating to the future operations of the Company and other statements that are not historical facts. Forward-looking statements are often identified by terms such as "will", "may", "should", "anticipate", "expects" and similar expressions. All statements other than statements of historical fact included in this news release (including, without limitation, statements regarding the future plans and objectives of the Company, research and development using psychedelic compounds, and the development of innovative devices and delivery mechanisms to improve mental health and wellness) are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those anticipated in such statements. Readers are cautioned that assumptions used in the preparation of the forward-looking statements may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company, including changes to the regulatory environment; that the Company's drug research and development activities may be unsuccessful; that drugs and medical devices produced by, or on behalf of, the Company, may not work in the manner intended or at all, and may subject the Company to product liability or other liability claims; that the Company may not be able to attain the Company's corporate goals and objectives; and other risk factors detailed in the Company's continuous disclosure filings from time to time, as available under the Company's profile at www.sedar.com. As a result, the Company cannot guarantee that any forward-looking statement will materialize and the reader is cautioned not to place undue reliance on any forward-looking information. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made only as of the date of this news release and the Company does not intend to update any of the included forward-looking statements except as expressly required by applicable Canadian securities laws. Drug development involves long lead times, is very expensive and involves many variables of uncertainty. Anticipated timelines regarding drug development are based on reasonable assumptions informed by current knowledge and information available to the Company. Every patient treated on future studies can change those assumptions either positively (to indicate a faster timeline to new drug applications and other approvals) or negatively (to indicate a slower timeline to new drug applications and other approvals). This news release may contain certain forward-looking statements regarding anticipated or possible drug development timelines. Such statements are informed by, among other things, regulatory guidelines for developing a drug with safety studies, proof of concept studies, and pivotal studies for new drug application submission and approval, and assumes the success of implementation and results of such studies on timelines indicated as possible by such guidelines, other industry examples, and the Company’s development efforts to date. In addition to the risk factors set out above and those detailed in the Company's continuous disclosure filings from time to time, as available under the Company's profile at www.sedar.com, other factors not currently viewed as material could cause actual results to differ materially from those described in the forward-looking statements. Although Lobe has attempted to identify important risks and factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors and risks that cause actions, events or results not to be anticipated, estimated or intended. Accordingly, readers should not place any undue reliance on forward-looking statements. Contact Details Philip Young info@lobesciences.com Company Website https://www.lobesciences.com

March 01, 2023 10:15 AM Eastern Standard Time

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Chronic Cluster Headaches No More: The Promise Of Lobe Sciences' At-Home Psychedelic Treatments Without The Trip!