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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

Video

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

Video

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

Is Market Sentiment Getting Behind This Emerging Small-Cap Specialty Syringe Medical Device Company?

Sharps Technology Inc.

By David Willey, Benzinga The medical device and supply manufacturing industry is focused on the design and production of medical instruments and devices. As innovation and demand for medical devices increase, the market for this industry, which is currently worth approximately $99 billion, is very likely to grow. However, it looks like the rising tide isn’t lifting all boats equally. It has been reported that the market is rallying behind some leaders in the industry, but not others. One of the reported rising companies is Sharps Technology (NASDAQ: STSS). A specialty syringe developer and manufacturer which has a market cap of just $15 million, Sharps is a company in the space that seems to be poised for growth and is receiving positive investor sentiment. The specialty medical device company recently received a bullish sentiment stock reading from investing group InvestorsObserver. At the same time, a number of other medical device companies have seemingly received underperforming commentary or are within the feeling of market uncertainty and hesitancy, such as Becton Dickson and Co. (NYSE: BDX), Cardinal Health (NYSE: CAH), and Terumo Corporation (OTC: TRUMY). Why is it that some medical device companies such as Sharps seem to have the support of market traders, while others don’t? There may be several contributing reasons. Investment Groups are Giving Sharps Technology a Positive Outlook The forum scoreboard on Investing.com shows Sharps Technology as having a 100% bullish sentiment rating from the forum’s users. Some traders on Stocktwits have also labeled Sharps’ stock as bullish. One trader cited the reduced capital needed to manufacture, as well as the reduced liability that comes with Sharps’ products, as reasons the company is well positioned in the market. Sharps has a wholly-owned 40K sq. ft manufacturing facility in Hungary with potential capacity of up to 200 million disposable syringe units in 2024, and through its collaboration with Nephron Pharmaceuticals (private), has potential capacity of up to 50 million units of prefillable syringe systems in South Carolina. Retail investment outlet Simply Wall Street highlighted Sharps as having high growth potential, suggesting that the stock currently trades at 98% below its estimate of fair value. Meanwhile, another investment consultant praised the company for its manufacturing capacity capabilities. Manufacturing scalability potential, along with synergies through the partnership with Nephron, were mentioned as having strong potential to lead to growth in topline revenue. A couple of recent announcements from Sharps may have also contributed to this seemingly bullish market sentiment. Sharps recently announced two significant progress updates with a press release on plans to introduce new specialized prefillable syringe systems in 2023, as well as shipping the first containers of syringes from its Hungary facility for commercialization. Interested in learning more about Sharps Technology? Visit its website. This article was originally published on Benzinga here. Sharps Technology is a medical device and pharmaceutical packaging company specializing in the development and manufacturing of innovative drug delivery systems. The company’s product lines focus on low waste and ultra-low waste syringe technologies that incorporate both passive and active safety features. These features protect front line healthcare workers from life-threatening needle stick injuries and protect the public from needle re-use. Sharps Technology has extensive expertise in specialized prefilled syringe systems and ready to use processing. The company has a manufacturing facility in Hungary and has partnered with Nephron Pharmaceuticals to expand its manufacturing capacity in the US. This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Adam Holdsworth- TraDigital IR adam@tradigitalir.com Company Website http://sharpstechnology.com/

March 01, 2023 09:40 AM Eastern Standard Time

This BioPharma Is Using Machine Learning To De-Risk Drug Discovery - Offering Everyday Investors A Chance To Own Equity

iMetabolic Biopharma Corporation

By Rachael Green, Benzinga Interested in investing in iMetabolic BioPharma’s campaign? Click here to get started! iMetabolic BioPharma (iMBP) has launched a StartEngine campaign to raise capital and give individual investors a chance to help fund the company’s mission to make more effective, more affordable treatments available to the communities that need them. The early-stage drug discovery company is working on cutting-edge treatments for diseases like cardiometabolic, cardiovascular and Alzheimer’s Disease that desperately need better options. By leveraging a unique tech-driven drug discovery process that uses machine learning and computational engineering, iMBP aims to cut the cost and time it takes to bring a drug to market so those important therapies can reach people faster and be provided at a fraction of the current new therapeutic cost. The StartEngine campaign is meant to raise additional capital to fund further development of its proprietary technology as well as further developmental research of the drug programs already in progress. The campaign also provides a mechanism for everyday people to invest in the exclusive world of early-stage biotech and participate in iMBP’s success The Classical Biopharma Drug Discovery Process Is Slow, Expensive, And Complex The traditional biopharma discovery process begins with identifying a molecular target that causes a disease. Then, researchers generate a library of protein-based drug candidates (biologics) through complex immunization and phage display campaigns. This generated library is then laboriously screened to find the candidates that act on that target. Once a shortlist is identified, researchers intensively refine, optimize and characterize these molecules to select the best lead for the intended purpose of beginning preclinical and clinical trials to test for safety and efficacy. Approximately 90% of drug programs fail to make it to market, meaning they never generate a return on the millions invested in that clinical research. About half of these failures are because the candidate wasn’t able to produce the intended effect and another 30% will fail due to toxicity or side effects. Meanwhile, the average cost of bringing a single drug to market is about $350 million. But that’s just for the drug that makes it to market – when you factor in failed drug programs, large pharmaceutical companies spend an average of $5 billion per new medicine. For patients, that means the price tag on their treatments has to cover not just the cost of developing that specific medicine but also make up for the sunk cost of all those failed drug programs. Life-saving therapies now end up costing tens to hundreds of thousands of dollars per year, per patient. In addition to being expensive, the current system can pressure drug developers to push a therapy forward without fully understanding or considering whether its benefits outweigh the potential risks. That doesn’t mean they’re manipulating data, per se, but systematic reviews do show that industry-funded clinical trials, those needed to gain regulatory approval, are more likely to report positive results than publicly-funded post-approval trials. This is, in part, because regulatory approval trials are designed to have primary endpoints, and provide patient support for protocol compliance and stringent patient selection criteria so that the drug candidate has the highest probability to show positive results. This is irrespective even if the endpoints and dosing protocols cannot truly demonstrate a reasonable clinical benefit, cost and/or treatment regimen that can benefit the full spectrum of patients who need the treatment. These industry-funded trials are also more likely to use placebos as their control rather than existing treatments for the disease in question. While there’s nothing wrong with that methodology, that means the drug candidate is effectively only being compared to receiving no treatment at all. But just because it’s better than getting no treatment doesn’t mean it’s better than the current best available treatment. iMBP’s Proprietary Technology Revolutionizes The Classic Discovery Process One reason for the high failure rate of clinical drug programs is that it’s hard to truly control the site of molecular targeting in classical biotechnology approaches. This leaves in question the optimal therapeutic effect or whether the design of this therapeutic candidate is really the best or safest to use. While existing scientific knowledge helps provide a foundation, the actual generation and selection process is really just trial and error, sometimes resulting in significant time delays that could result in a “good enough” selection criteria. By the time researchers realize that a therapeutic candidate is either ineffective or unsafe, the developer may have already sunk millions into preclinical or clinical trials. With the iPlatform ™, iMBP is essentially aiming to fail and iterate faster, meaning it can rule out unlikely therapeutics candidates early on in the process before it’s invested significant time, money, and resources into it. This tech-driven biotechnology approach is the next stage of drug discovery evolution and is now becoming generally referred to as “TechBio”. The approach at iMBP to improve the therapeutic discovery process uses machine learning to analyze molecular interactions allowing for strategic protein engineering to enhance both potential therapeutic action and safety. This very quickly creates a narrow list of the highest value candidates that are most likely to succeed. The patent-pending platform leads to significant savings of both time and money for iMBP, but it provides an innovative approach to design and test therapeutic candidates that could also lead to more effective and more affordable treatments for patients. Instead of drugs that barely meet endpoints, don’t really improve on the existing treatments out there, or do so only alongside a host of harmful side effects, the precision iPlatform ™ provides to the discovery phase enables the company to create therapeutic solutions that are most likely to offer significant clinical benefits. Using TechBio, iMBP is pioneering the field as it has already developed five therapeutic programs targeting a range of cardiometabolic and cardiovascular diseases, as well as Diabetes and Alzheimer’s disease. These diseases currently affect over 100 million Americans alone. The biopharma also has four more programs in preparation. Now, everyday investors have a chance to invest in iMBP’s innovative approach to drug discovery and the lifesaving treatments it’s aiming to deliver to communities. iMBP is raising capital via a StartEngine campaign where investors can join a community of action and directly support this early-stage innovation and participate in its growth and success. Learn more about the technology and vision as well as the investment terms here. This article was originally published on Benzinga here. iMetabolic Biopharma Corporation (iMBP) is an early-stage drug discovery company innovating at the intersection of technology and biotechnology to develop new, life-saving drugs to fight against some of today's most devastating chronic diseases affecting our loved ones. Currently, we are pre-market, advancing five different disease asset programs, and in the process of developing a proprietary technological platform for the discovery of more effective and less expensive drugs. This will allow us to continuously expand our drug pipeline while increasing company value. This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investing advice. The preceding post was written and/or published as a collaboration between Benzinga’s in-house sponsored content team and a financial partner of Benzinga. Although the piece is not and should not be construed as editorial content, the sponsored content team works to ensure that any and all information contained within is true and accurate to the best of their knowledge and research. Benzinga may receive monetary compensation from the issuer, or its agency, for publicizing the offering of the issuer’s securities. This content is for informational purposes only and is not intended to be investing advice. This is a paid ad. Please see 17b disclosure linked in the campaign page for more information. Contact Details Nathan Hyland Info@imbiopharma.com Company Website https://imbiopharma.com/

March 01, 2023 09:25 AM Eastern Standard Time

Right On Brands Inc. announces Chief Marketing Officer

Right On Brands, Inc.

McapMediaWire -- Right on Brands, Inc. (OTC: RTON ), a leader and innovator of HEMP DERIVED and WELLNESS products is pleased to announce today that Brock Ellison will join us as our new Chief Marketing Officer and PR officer, “Brock brings an impressive wealth of experience and knowledge to our company, having worked extensively in both digital marketing and small startups positions for over ten years say Jerry Grisaffi CEO.” In Brock's opinion, customer-centric strategies and his expertise lies in product development, digital marketing, and brand Based on his innovative and tailored thinking, companies have become more successful month-over-month after he developed his strategy. Some of those brands include AT&T, Under Armor, MAC Cosmetics, MD Anderson Cancer Center and his own digital agency, The Loyal SEO. Right On Brands Inc. and our subsidiaries truly believe the key to great marketing is understanding customers' needs and building relationships that leave a positive impact on our community. Brock is ready to show us the creativity he will bring to your favorite brand, through improving different marketing initiatives. With his leadership and knowledge, we will achieve even more by driving growth and making a positive impact on our community. On a personal note, Brock is here to help us make a real difference to improve the life of those suffering from chronic pain and illnesses. Prior to Endo Brands, he was a full-time caregiver to his mom, who passed in April 2020 from Stage 4 breast cancer. Furthermore, he has had success in digital marketing for dispensaries as he lived in Colorado from 2016 to 2018. Brock graduated from the University of Houston in 2011 with a degree in Public Relations and Marketing. “We're excited to put his skills to work for our team and the community, so we can build meaningful relationships and promote positive change”, says Grisaffi. Welcome aboard, Brock! Forward-Looking Statements This press release contains information that constitutes forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of All such forward-looking statements involve risk and uncertainties that could cause actual results to differ materially from any future results described by the forward-looking statements. Risk factors that could contribute to such differences include those matters more fully disclosed in the Company's reports filed with the SEC. The forward-looking information provided herein represents the Company's estimates as of the date of this press release, and subsequent events and developments may cause the Company's estimates to change. The Company specifically disclaims any obligation to update the forward-looking information in the future. Therefore, this forward-looking information should not be relied upon as representing the Company's estimates of its future financial performance as of any date after the date of this press release. If you know anyone that would like to know more about becoming an Endo Dispensary store, please contact us at: jerry@rightonbrands.com About Right on Brands: Right on Brands, Inc., (OTC: RTON) is a Dallas based, consumer goods company specializing in the brand development and distribution of hemp-based foods, beverages, smokables, oils and topical products. Right on Brands, Inc. is a developer of a broad line of hemp-based smokables, beverages, tinctures, and topical products including products infused with CBD, Delta-8, Delta-10, THCV, CBDV, and Delta-9 (below the federal limit) and the all new HHC vapes, gummies and tinctures. About ENDO Brands: ENDO Brands™, Humbly Hemp®, and ENDO Dispensary & Wellness™ Endo Franchise Group Inc, all share the same goal of providing our customers with the best products in the health and wellness space. As the field of health and wellness products expand, Right on Brands will be there with industry leading Food and Beverage and wellness Products. To learn more, please visit: https://rightonbrands.com/ www.endobrands.com www.ENDOdispensaryrowlett.com email: jerry@rightonbrands.com or mike@rightonbrands.com or call Mike Brown (214) 299-9528 ENDO Brands Corporate Store: ENDO Brands at Lakeview Plaza 6501 Dalrock Road Suite 100 Rowlett, Texas 75089 214-299-9528 AUSTIN LOCATION 12412 Limerick Avenue, Austin, Texas 78758 www.endoofaustin.com 512-621-0649 LAREDO LOCATION ENDO Laredo 2413 Jacaman Rd Laredo, Texas www.endolaredo.com 956-568-2300 HOUSTON LOCATION 3301 Louetta Rd Ste 109 Spring, Texas 77388 832-583-5383 (Website coming soon) MIAMI FLORIDA LOCATION 10850 SW 104 th St, Miami, Florida 33156 www.endo-miami.com PLANO LOCATION 601 W. Parker Road, Plano, Texas 75023 469-366-9694 NOW OPEN DALLAS LOCATION 9585 Scyene Road, Dallas. Texas NOW OPEN (Website coming soon) Contact Details Mike Brown mike@rightonbrands.com Company Website https://rightonbrands.com/

March 01, 2023 09:00 AM Eastern Standard Time

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Healthcare