Digital Asset DirectOxford Cannabinoid Technologies Holdings PLC
Contact Details Proactive Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com
November 15, 2022 10:22 AM Eastern Standard Time
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News ReleaseAgile Therapeutics, Inc.
Agile Therapeutics Inc. (NASDAQ: AGRX) is on a journey to fulfill the unmet health needs of women with products designed to provide them with contraceptive options. The company’s product and product candidates are designed to provide women with contraceptive options that offer freedom from taking a daily pill without committing to a longer-acting method. Twirla® Agile ’s initial product Twirla® (levonorgestrel and ethinyl estradiol) transdermal system, is a nondaily prescription contraceptive based on the company’s proprietary transdermal patch technology called Skinfusion®, which is designed to allow drug delivery through the skin. The Twirla transdermal system is a once-weekly combined hormonal contraceptive (CHC) patch that contains the active ingredients levonorgestrel (LNG), a type of progestin, and ethinyl estradiol (EE), a type of estrogen. The patch is used as a contraceptive by women with a body mass index (BMI) less than 30 kilograms per meter (kg/m2) for whom a combined hormonal contraceptive is appropriate. It is less effective in women with a BMI of 25 or more. Q3 Financial Results And Corporate Update On Nov. 7, Agile released financial results for the three months that ended Sept. 30 and provided a corporate update. Financial Results Highlights: Net revenue: Twirla delivered $3.0 million in net revenue for the third quarter of 2022. This was an increase of 43% from the second quarter of 2022 – the largest quarter-over-quarter increase the Company has achieved. Cost of product revenue: Cost of product revenue totaled $1.4 million and consisted of direct and indirect costs related to the manufacturing of Twirla® sold, compared to $2.7 million for the third quarter of 2021 – a decrease of 47%. The decrease reflects the elimination of an inventory obsolescence reserve, which the company established in the third quarter of 2021. Total generally accepted accounting principles (GAAP) operating expenses: Total GAAP operating expenses were $20.3 million for the quarter that ended Sept. 30, compared to $14.4 million for the comparable period in 2021 — an increase of 41%. The GAAP operating expenses for the third quarter of 2022 represent an increase of 80% from the $11.3 million of GAAP operating expenses reported for the second quarter of 2022. Total non-GAAP operating expenses: Total non-GAAP operational expenditures were $9.2 million for the quarter that ended Sept. 30, compared to $14.4 million for the comparable period in 2021 — a decrease of 36%. The non-GAAP operating expenses for the third quarter decreased 19% from the $11.3 million non-GAAP operating expenses reported for the second quarter of 2022. The company had a one-time, non-cash charge associated with the transfer of equipment to Corium in the third quarter and believes the non-GAAP operating expense, which excludes this charge from GAAP operating expenses, presents a more useful comparison of the results from its operations because prior periods did not include a similar charge. The company provided a reconciliation of its GAAP operating expenses versus non-GAAP operating expenses in its press release. Cash: As of Sept. 30, the company had $6.1 million of cash, compared to $13 million of cash and cash equivalents as of the end of the second quarter of 2022. Net loss: Net loss was $19.7 million, or 53 cents per share for the quarter that ended Sept. 30, compared to a net loss of $16.8 million, or $7.20 per share, for the comparable period in 2021. The company incurred a one-time, noncash operating expense charge of $11.1 million in the third quarter of 2022 related to the transfer of equipment ownership to Corium Inc., which is reflected in the net loss for the third quarter of 2022. Shares outstanding: As of Sept. 30, Agile had 39,026,823 shares issued and 36,997,836 weighted average shares of common stock outstanding. Key Contributors To Future Growth Although the company reported a net loss for the quarter due to reasons that included extraordinary ones, it says it has an effective business plan in place and is tracking towards its goal of generating positive cash flow. An important contributor to the company’s third-quarter growth was its partnership with Afaxys Inc., which drove volume in the nonretail channel. In the second quarter of 2022, 1,404 nonretail cycles of Twirla®were purchased, and that number surged 361% in the third quarter to 6,479 nonretail cycles. “This growth is the product of the efforts being made by Afaxys to penetrate the Planned Parenthood network. In the third quarter, we began to see the conversion of Planned Parenthood accounts in California, which drove significant sales and growth for the quarter. We believe this represents a sustainable customer base for future periods,” Agile Therapeutics Chief Commercial Officer Amy Welsh said. She added that by focusing on five key states — California, Texas, Florida, Illinois, and New York — “It is estimated that we can reach 45% of U.S. women between the ages of 18 and 24. In the future, we expect the retail channel to continue to grow.” Additionally, Agile plans to launch its collaboration with female telehealth leader Nurx in the fourth quarter of 2022 and expects the collaboration to begin to contribute to retail channel growth in 2023. Nurx is a leader in female-focused digital healthcare amongst the Twirla target audience and offers patients access to its telehealth platform and expert medical providers that have prescribed contraception to more than 1 million patients Generating Positive Cash Flow In an industry with players like Dare Bioscience Inc. (NASDAQ: DARE) and Hologic Inc. (NASDAQ: HOLX), Agile is exploring business development opportunities that could potentially accelerate the timeline for generating positive cash flow. “Our stated plan has been to effectively manage expenses while continuing to grow Twirla® sales and demand. This is the third consecutive quarter we have increased Twirla® sales and demand while simultaneously decreasing company operating expenses, excluding the noncash, one-time charge incurred this quarter,” Chairman and CEO and Director of Agile Therapeutics Chairman and CEO Alfred Altomari said. “We are working — and have been working — to identify and implement strategies and exploit opportunities that will contribute to further growth,” he added. If Agile maintains its quarterly revenue growth rate and operating expenses consistent with the past two quarters, the company could potentially begin to generate positive cash flow at the end of 2023. The addition of a business development opportunity or partnership could potentially accelerate that timeline. Agile Therapeutics is a women's healthcare company dedicated to fulfilling the unmet health needs of today’s women. Our product and product candidates are designed to provide women with contraceptive options that offer freedom from taking a daily pill, without committing to a longer-acting method. Our initial product, Twirla®, (levonorgestrel and ethinyl estradiol), a transdermal system, is a non-daily prescription contraceptive. Twirla is based on our proprietary transdermal patch technology, called Skinfusion®, which is designed to allow drug delivery through the skin. This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Matt Riley - Head of Investor Relations & Corporate Communications mriley@agiletherapeutics.com Company Website https://agiletherapeutics.com/
November 15, 2022 08:15 AM Eastern Standard Time
Digital Asset DirectArecor Therapeutics PLC
Contact Details Proactive Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com
November 15, 2022 07:43 AM Eastern Standard Time
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News ReleaseThe Chicago School of Professional Psychology
The Chicago School of Professional Psychology recently named three outstanding business, professional, and community leaders to its Board of Trustees. They join the existing 12-member board of the 43-year-old non-profit educational institution, which serves 6,000 students on seven campuses nationwide. “We are pleased to have such distinguished leaders join our board” said Dr. Michele Nealon, Psy.D., President of The Chicago School of Professional Psychology. “These individuals have the skills and background to help us meet the challenges of preparing future mental health professionals, especially those interested in working in underserved communities.” Sian Seligman of Los Angeles is the Chief Marketing Officer for Resonate Blends, a cannabis holding company and innovation lab that develops cannabis wellness products under the brand Koan. She worked for two decades as a brand marketing and consumer strategist for Fortune 500 companies, gaining a deep understanding of the buying habits and psycho-social motivations of the American consumer. In 2020, Seligman became the youngest person and first Asian American female to head the Board of Governors at the City Club Los Angeles, where she managed a major reorganization while retaining 85 percent of club membership in the midst of forced closure due to the pandemic. Seligman holds an MS in Herbal Medicine from the American College of Healthcare Sciences and a BS in Business Administration from Cal Poly Pomona. ______________________________________________________________________________ Eloisa Perard of Los Angeles is CEO & President of QueensCare Health Centers (QHC), a non-profit, Federally Qualified Community Health Center organization, with five health centers in underserved neighborhoods of Los Angeles. “I look forward to adding my expertise to the board in generational trends and insights,” she said. “My goal is to bring diverse and innovative thinking about the future of higher learning, particularly mental wellness education.” Perard has also held executive positions in education and manufacturing since earning an MS in Organizational Psychology and a BS in Organizational Management from the University of La Verne. Perard serves as Treasurer on the Board of Directors of Community Clinics Association of Los Angeles County (CCALAC), a non-profit network that advocates for expanding access to health care for the medically underserved people in Los Angeles County. She also serves on the Board of Directors of Health Care L.A. (HCLA), an Independent Physician Association (IPA). Dina Torrisi Martin of Chicago is General Counsel of the Illinois Department of Financial and Professional Regulation, where she heads the Office of Legal Affairs. As counsel to the Secretary, Division Directors, and executive staff of this agency, she oversees litigation and administrative hearing decisions, and formulates policy decisions. “As the pandemic surely highlighted, mental well-being is an imperative,” said Martin. “I am honored to become a trustee and look forward to working with the growing Chicago School community.” She is a former partner and head of medical malpractice at Hughes Socol Piers Resnick & Dym, Ltd., where she represented hospitals and health professionals before regulatory agencies. Torrisi Martin is an elected member of the American Board of Trial Advocates, the Society of Trial Lawyers, and other professional organizations. She earned a JD from the University of Illinois Chicago School of Law and a BA in Political Science from the University of Illinois Urbana-Champaign. # About The Chicago School of Professional Psychology: Integrating theory with hands-on experience, The Chicago School of Professional Psychology provides education rooted in a commitment to innovation, service, and community for thousands of diverse students across the United States and globally. Founded in 1979, the nonprofit, regionally accredited university now features campuses in iconic locations across the country (Chicago, Southern California, Washington, D.C., New Orleans, Dallas) and online. To spark positive change in the world where it matters most, The Chicago School has continued to expand its educational offerings beyond the field of psychology to offer more than 30 degrees and certificates in the professional fields of health services, education, counseling, business, and more. Through its engaged professional model of education, commitment to diversity and inclusion, and an extensive network of domestic and international professional partnerships, The Chicago School’s students receive real-world training opportunities that reflect their future careers. The Chicago School is proud to be a part of TCS Education System, a nonprofit, integrated system of colleges and universities that works collaboratively to advance student success and community impact. To learn more, visit www.thechicagoschool.edu. Contact Details Vivien Hao +1 323-893-4743 vhao@thechicagoschool.edu
November 14, 2022 11:00 AM Pacific Standard Time
News ReleaseAccelmed PR and SKNV
Accelmed Partners (“Accelmed”), a private equity firm focused on acquiring and investing in U.S. commercial stage, lower middle market HealthTech companies, today announced that it concluded a $35 million investment in SKNV Inc. a full continuum-of-care dermatology digital health company for in-practice dispensing and ecommerce of customized prescriptions and skincare. Lake Street Capital served as sole financial advisor on the transaction Founded in 2016 by Dr. Spencer Malkin, SKNV is the market leader and FDA-Registered 503B Outsourcing Facility for customized medications dispensed directly from dermatology practices. With customized medicines making a clinical difference across the 12 most common dermatological diagnoses, SKNV enables doctors to determine the prescription potency and active ingredient customization needed for targeted results to their individual patients. By offering dermatology practices a complete system that includes customized medications and the proprietary technology platform required for compliant dispensing and patient management, SKNV is uniquely positioned to meet the needs of both modern practice operations and precision patient care. The Company’s digital health platform allows local practices to focus on optimized daily care, while providing 24/7 tools to improve drug adherence, refill automation, and telehealth options for patients. Dr. Uri Geiger, Managing Partner of Accelmed, said, “SKNV has developed a best-in-class customized digitally driven medication system that puts the power of prescriptions back in the hands of doctors and patients. For too long, middlemen players have driven up the cost and complexity of prescription medicine, often inserting their power to deny or change the prescription that doctors order for patients in their care. SKNV is changing that power dynamic by giving dermatology practices and their patients the autonomy to make the right decisions for their unique prescription needs. With their unmatched level of targeted Rx care and digital health convenience combined with a wallet-friendly price, SKNV's customized medications are the affordable, best choice for dermatology patients. What makes this even more impressive is how SKNV is helping reaffirm and redefine the lead role of the local practice and prescribing doctor in the future of digital-enabled healthcare. We are excited to partner with Spencer and the entire SKNV team to further expand the Company’s geographic footprint, operational capabilities, and digital health technologies to serve more customers across the United States.” Proceeds from the investment round will be used to help SKNV advance its new, state-of-the-art manufacturing facility in Florida, scale its proprietary digital health platform, increase its sales team footprint across the U.S., and expand its management team with strategic hires. Dr. Spencer Malkin, Founder and CEO of SKNV, added, “We are partnering with Accelmed because they share in our vision for a dermatology ecosystem that connects local practices and customized medicine with the latest in digital health technologies to drive patient care compliance and prescription drug adherence. The real future of healthcare combines digital and local care to improve patient outcomes. As others continue their pursuits to displace dermatology practices, SKNV empowers community doctors with the advanced, customized solutions that modern patients seek without losing the personal care from local providers they trust. Accelmed’s operational expertise and industry-wide connections are key to expediting our growth from an innovative market leader in customized medicine to the new pharma standard for dermatology.” About Accelmed Partners Accelmed is a U.S.-based private equity firm focused on acquiring and investing in U.S. commercial stage, lower middle market HealthTech companies. Since 2009, Accelmed has deployed over half a billion dollars into companies spanning medical devices, diagnostics, digital health and technology-enabled healthcare services. Accelmed seeks to accelerate value and scale innovation across the HealthTech field by bringing to bear the team’s industry experience, operational and financial expertise, and strong global relationships. For more information, please visit www.accelmed.com. About SKNV Inc. SKNV is a pioneer in customized medications and skincare solutions for leading dermatology practices across the United States. Combining a fully integrated, in-office dispensing solution for local doctors with a digital health ecommerce platform for monthly patient refills, SKNV places the power to determine and fully manage customized prescription care paths back in the hands of local providers. The SKNV Customized Dermatology System delivers targeted results and repeat purchases through tailored regimens in preventative, curative, and maintenance skin care. More information is available at www.sknv.com. Contact Details Amanda Klein/Alex Jeffrey Gasthalter & Co. +1 212-257-4170 Accelmed@gasthalter.com Company Website https://www.accelmed.com
November 14, 2022 12:58 PM Eastern Standard Time
Digital Asset DirectNews Media Group, Inc.
Contact Details Karl Wayne +1 334-440-6397 karl@newsmg.com Company Website https://newsmg.com/
November 14, 2022 11:30 AM Eastern Standard Time
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News ReleaseInspirant Group
Inspirant Group, the award-winning disruptive management Consulting firm, has appointed Ryan VanDePutte as Sales Director. With a multi disciplinary background, VanDePutte has deep experience in project delivery, enterprise, and mid-market sales, assisting companies in simplifying their unique business and technology challenges. In his new role, VanDePutte will drive transformation initiatives and business development for the fast-growing Chicagoland company. “We’re thrilled to welcome Ryan to our team of Unconsultants. It is the exact right time to have his leadership and expertise at this stage of Inspirant Group ’s growth as we continue to expand our service offerings,” said Meighan Newhouse, Co Founder and CEO, Inspirant Group. “I’m delighted to join Inspirant Group and the talented team of Unconsultants in developing the Appian practice area,” VanDePutte shared. “This will allow us to draw upon the team’s collective knowledge base and experience in delivering best in class transformation initiatives to our clients.” VanDePutte holds a Bachelor of Science degree in operations management and information systems from Ball State University - Miller School of Business. He resides in the Chicagoland area with his wife and three children. Founded in 2017, Inspirant Group is the award-winning, remote-first management “UNconsulting” firm that takes companies from inspiration to transformation. By stripping away the bureaucracy and complexity associated with the traditional “big 4” and mid-tier consulting firms, Inspirant ’s team of UNconsultants delivers high touch service and advises clients in three service lines: strategy & operational agility, talent & organization, and technology & data. This mirrors the company’s approach to any engagement: optimize processes, ensure the right people are in the right seats, and make the tech and data work for the client (and not the other way around). Headquartered in Chicago, Illinois, Inspirant is Certified™ by Great Place to Work ®, the employee experience award, and was honored with two 2022 Built In awards including Best Remote-First Places to Work in the US and 22 StartUps to Watch in Chicago. For more information, visit: Inspirantgrp.com and follow us on LinkedIn. Contact Details Julie Livingston +1 347-239-0249 julie@wantleverage.com Company Website https://inspirantgrp.com
November 14, 2022 09:30 AM Central Standard Time
News ReleaseOrganicell Regenerative Medicine, Inc.
Learn More about Organicell Regenerative Medicine, Inc. by gaining access to the latest research report In the medical community, the popularity of regenerative medicine is reportedly soaring primarily because research around these therapies shows promise in treating a wide range of musculoskeletal pain conditions. Armed with the belief that the human body can heal itself, regenerative medicine treatments like exosome therapy and stem cell therapy are advancing. But regenerative medicine has sometimes been embroiled in controversy beginning in 1981 when scientists discovered ways to derive embryonic stem cells from early mouse embryos. That discovery was followed by a method to derive stem cells from human embryos and grow the cells in the laboratory in 1998. Massive players like Amgen Inc. (NASDAQ: AMGN), Sanofi SA (NASDAQ: SNY), and Gilead Sciences Inc. (NASDAQ: GILD) have advanced stem cell research and therapies. Is Exosome Therapy Different? Unlike stem cell therapy, Organicell’s (OTCMKTS: OCEL) exosome therapy doesn't involve using donor cells or umbilical cords. Instead, the exosomes are extracted from full term, planned C Section, Amniotic fluid. The extracted exosome solution is derived from amniotic fluid and contains over 300 soluble proteins as growth factors, cytokines and chemokines, extracellular matrix proteins as fibronectin and collagen, structural molecules as hyaluronic acid, Nanoparticles as extracellular vesicles, exosomes and surfactants proteins, valuable lipids, micro-RNA, messenger-RNA, and cytokines. Exosome therapy, according to experts, is a highly targeted, flexible treatment believed to help inflammatory conditions like COPD, Long Covid, musculoskeletal injuries, osteoarthritis, and chronic pain. What’s the difference between Exosomes and Stem Cells? Try to think of Stem Cells as microchips in a computer. Exosomes are like the software. South Florida-based Organicell Regenerative Medicine Inc. (OTCMKTS: OCEL) is a company that is a pioneer in the exosome space. Their products are designed to operate like software for the computers of our body known as cells. However, the software Organicell uses is naturally occurring and unaltered. Organicell extracts its exosomes from what is believed to be one of the most naturally healing fluids on the planet, amniotic fluid. The software/exosomes in this fluid reminds the body what it used to do when it was young. To put things plainly, the “software” (exosomes) is a set of instructions, data or programs used to operate the “computers” (cells) and execute specific tasks, while a computer-chip (stem cells) are used more as building blocks in regenerative medicine. Potential Benefits The potential benefits of Organicell’s products could be enormous. For example, the company's investigational product Zofin™ is an acellular, non-HCT/P biologic, currently being studied in clinical trials. The company accomplished the difficult task of an approved investigational new drug (IND) from the U.S. Food and Drug Administration (FDA) which lead to approved clinical trials.. Zofin™ is derived from perinatal sources and is manufactured to retain the naturally occurring nanoparticles and microRNAs without manipulation or adding or combining any other substance. Zofin™ is currently being studied in FDA Phase I/II clinical trials for COVID-19, Long Covid, Chronic Obstructive Pulmonary Disease (COPD), and ready to begin a trial for Osteoarthritis of the knee. Below are the results that were published on the COVID patients treated with Zofin under eIND approval. The important items in the chart are the key biomarkers that measure inflammation: IL-6 and CRP as well as the chest X Rays that show the structural difference in the lungs over time. A Better Approach? Organicell reports that its mission is to be the first company to prove the efficacy of extracellular vesicles (EV's) — a.k.a exosomes — on inflammatory ailments. Organicell has two active FDA approved clinical trials for Long Covid and COPD. The company says through its ground-breaking research in the field of nanotechnology, specifically perinatal-derived EVs, it has created the drug candidate, Zofin, that could be the next frontier of regenerative biologic therapeutics. Organicell’s proprietary product’s biological representation is allogenic amniotic fluid (secreted body fluid, non-HCT/Ps), which is an acellular product derived from human amniotic fluid (HAF). The product contains no addition or combination of any other substance or diluent during production. Moreover, the product quality assurance is seemingly unmatched in the regenerative medicine space. the donor from whom this product was derived has been tested and found negative for the following: HBsAg (Hepatitis B Surface Antigen), HBcAb (hepatitis B core antibody), HCV (hepatitis C antibody), HIV I/II-Ab (Antibody to Human Immunodeficiency Virus Types 1 and 2), Syphilis detection test, HIV NAT (HIV Nucleic Acid Test), and HCV NAT (HCV Nucleic Acid Test). Additional donor screening tests may have been performed on the donor. If additional tests for Human Immunodeficiency Virus, Hepatitis B, Hepatitis C or Syphilis were performed, the results were reviewed and found to be NEGATIVE. Additional tests for other communicable diseases, such as West Nile Virus, T. Cruzi, Cytomegalovirus and Epstein Barr Virus may have been performed. The results of all additional communicable disease tests have been evaluated by the Medical Director and have been found acceptable according to regulations, standards and Standard Operating Procedures (SOPs). Donor screening tests are performed by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and American Association of Blood Banks (AABB) using FDA licensed tests when available performed by VRL Laboratories. The donor is selected based on medical and social history which meets the Standards of the American Association of Tissue Banks (AATB) United States Public Health Service (USPHS), and the Federal Food and Drug Administration (FDA). Donor suitability was determined by the Manufacturing Facilities’ Medical Directors (Organicell Regenerative Medicine, 1951 NW 7th Ave, Suite 300, Miami, FL 33136). Organicell Factor X is manufactured for clinical use under cGMP-compliant manufacturing facility, to control potency and purity of the product. Organicell Regenerative Medicine, Inc. (OTCQB:OCEL) is a clinical-stage biopharmaceutical company principally focusing on the development of innovative biological therapeutics for the treatment of degenerative diseases and the provision of other related services. The Company's proprietary products are derived from perinatal sources and manufactured to retain the naturally occurring exosomes, hyaluronic acid, and proteins without the addition or combination of any other substance or diluent. Certain of the statements contained in this press release should be considered forward-looking statements within the meaning of the Securities Act of 1933, as amended (the "Securities Act"), the Securities Exchange Act of 1934, as amended (the "Exchange Act"), and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are often identified by the use of forward-looking terminology such as "will", "believes", "expects", "potential", or similar expressions, involving known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, they do involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect. We remind you that actual results could vary dramatically as a result of known and unknown risks and uncertainties, including but not limited to: potential issues related to our financial condition, competition, the ability to retain key personnel, product safety, efficacy and acceptance, the commercial success of any new products or technologies, success of clinical programs, ability to retain key customers, our inability to expand sales and distribution channels, legislation or regulations affecting our operations including product pricing, reimbursement or access, the ability to protect our patents and other intellectual property both domestically and internationally, and other known and unknown risks and uncertainties, including the risk factors discussed in the Company's periodic reports that are filed with the SEC and available on the SEC's website (http://www.sec.gov). You are cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these risk factors. Specific information included in this press release may change over time and may or may not be accurate after the date of the release. Organicell has no intention and specifically disclaims any duty to update the information in this press release. This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Organicell Investor Relations IR@organicell.com Company Website https://organicell.com/
November 14, 2022 09:17 AM Eastern Standard Time
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Digital Asset DirecthVIVO PLC
Contact Details Proactive Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com
November 14, 2022 06:14 AM Eastern Standard Time
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