Digital Asset DirectPoolbeg Pharma wins first non-dilutive grant funding
Poolbeg Pharma PLC
Contact Details Proactive Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com
November 21, 2022 06:35 AM Eastern Standard Time
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Digital Asset Direct
News ReleaseThe Chicago School of Professional Psychology Supports Second-Career Students
The Chicago School of Professional Psychology
After a dozen years working in the wine industry, millennial Joy Makin is shifting her career focus to counseling individuals who are often forgotten by society. As a doctoral candidate in forensic psychology at the Los Angeles campus of The Chicago School of Professional Psychology, she says her goal is to help formerly incarcerated men and women get back on track with their lives. “I was tired of feeling like I was just making more profit for some corporation when I was working for wineries,” she said. “It’s important to me to be able to make a difference and I am hoping I will be able to do that as a forensic psychologist.” A native of a small farming town in California’s Central Valley, Makin said she had a front-row seat to the effects of alcohol and drug addiction. “I want to help people find ways to cope without harming themselves or others,” she said. “We all mess up and deserve a second chance in life.” Makin is just one example of The Chicago School’s second-career students who are poised to become the next generation of psychotherapists, counselors and psychologists with real world experience. She and her fellow graduates will enter a wide-open job market where the need is growing while many mental health professionals are reaching retirement age. A recent Chicago School graduate, Dr. Charles Robinson, was a classroom teacher for years in Illinois urban schools where he saw how his students struggled with mental health challenges. “I felt I could help to address core issues such as anxiety, depression and stress, which adversely affect learning,” he said. “I chose The Chicago School, and earned a doctorate in school psychology so I could more effectively support students in my community.” Another graduate, Dr. Bethany Patterson, had to juggle family, work and school, while seeking a doctoral degree at The Chicago School’s Washington D.C. campus. A military spouse and mother of three, she graduated last month and is already employed as clinical director at Helianthus Positive Behavior Supports, a provider of counseling services to children and families in Virginia and North Carolina. “I needed a school that was supportive and respectful of the military lifestyle because I had unique needs,” she said. “I found a place where the learning environment is optimized by active learners with diverse cultures,” she said. “Today I embody The Chicago School’s values of innovation, service, and community by creating a space for military spouses to encourage each other and further their education.” 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 17, 2022 11:00 AM Pacific Standard Time
News ReleaseThis Kevin Hart-Endorsed Electric Toothbrush Could Be The Perfect Gift For The Holidays
Bruush Oral Care Inc.
Apart from merrymaking, the holiday season is about giving. People shop and buy gifts for their loved ones — family, friends or colleagues. From exciting deals on apparel, TVs and video games to edibles like candies and chocolates, there is an endless list of gift options during the yuletide. With such an impressive and wide array of products offered during holiday shopping, especially on Black Friday, choosing the perfect gift for a loved one can sometimes be challenging. No one wants their gift to be returned. A Perfect Gift? Finding the perfect gift is challenging, but one present that could leave a permanent smile on the recipient is an electric toothbrush. Why an electric toothbrush? For starters, good oral health translates to good health overall, and electric toothbrushes are known to provide superior plaque removal to regular manual toothbrushes. But you wouldn’t just get any electric toothbrush. A good electric toothbrush like one from Brüush Oral Care Inc. (NASDAQ: BRSH) might be a perfect gift for the holiday season. Unlike other electric toothbrushes on the market, Brüush says its top-of-the-line technology blows the competition out of the park. Brüush reports its technology delivers 42,000 brushstrokes per minute, eradicating plaque by 20% more than manual toothbrushes. Based in Vancouver, British Columbia, Canada, Brüush is a leading modern electric toothbrush brand looking to disrupt the oral care market. It delivers on its promises, giving people their healthiest, cleanest teeth. Black Friday SaleThe company has launched its Black Friday sale. They are offering a sitewide discount code for 25% Off: CYBER25. To check out this deal visit https://bruush.com.90% Five-Star Review Rating With Less Than 1% Return Rate? From the more than 90% five-star review rating with less than 1% return rate, Brüush could be a perfect gift choice this holiday season and a personal favorite of many. And the reviews are endless. "Never Using a Different Brush! This is the greatest toothbrush I've ever used and I have tried Sonicare, Quip, and other electric brushes… I gave my boyfriend a Brüush for Christmas and he also loves it, these are great gifts to give someone!" a reviewer said. Another user, who seems to be attesting to the functionality of the Brüush, also said, "Unbeatable value and power. The power and battery life is a game changer! Gentle enough on sensitive gums and teeth but strong enough to make you FEEL the deep clean." "Using the Brüush has made my teeth feel cleaner than any toothbrush I've ever used! Brüush is like Michael Jordan and my old toothbrush is like Isaiah Thomas," a user controversially said. The reviews show that people are turning to more convenient and efficient ways of keeping up a healthy lifestyle. The convenience means Brüush does all the hard work, like keeping the gums, tongue and teeth cleaner and healthier. Brüush believes that it disrupting the global oral care market, which was valued at $33.7 billion in 2021 and is expected to expand at a compound annual growth rate (CAGR) of 6.4% from 2022 to 2030. The global electric toothbrush market is projected to grow from $3.05 billion in 2021 to $3.99 billion in 2028 at a CAGR of 3.9%. Companies like Brüush, Koninklijke Philips NV (AMS: PHIA) and Procter & Gamble Co. (NYSE: PG) are expected to play a vital role in the sector’s growth. For customers who may pick up a Brüush for personal use or as a gift this holiday season, the company says its brush features six cleaning modes and extra-soft bristles, a superior option to what the competition may offer. Brüush reports that its brand story is best told through smiles, and comedian and actor Kevin Hart knows how to make people smile. After trying the company’s toothbrush himself — and loving it — an authentic partnership was formed in 2020. As a strategic investor and partner, Kevin is on board with Brüush’s mission to elevate self-confidence through cleaner, whiter teeth — making people laugh along the way. Besides providing what the company reports as a top-of-line device, Brüush also offers a subscription plan, making them a go-to for many users. Every six months, Brüush ships three new brush heads for $18 with free shipping. Learn more about Brüush by downloading the latest research report here Featured photo by bruush.com About Bruush Oral Care Inc. Bruush Oral Care Inc. is on a mission to inspire confidence through brighter smiles and better oral health. Founded in 2018, Brüush is an oral care company that is disrupting the space by reducing the barriers between consumers and access to premium oral care products. The Company is an e-commerce business with a product portfolio that currently consists of a sonic-powered electric toothbrush kit and brush head refills. Brüush has developed a product to make upgrading to an electric brush appealing with three core priorities in mind: (i) a high-quality electric toothbrush at a more affordable price than a comparable electric toothbrush from the competition; (ii) a sleek, countertop-friendly design; and (iii) a convenient brush head refill subscription program that eliminates the frustrating experience of purchasing replacement brush heads at the grocery/drug store. The Company is rooted in building a brand that creates relevant experiences and content, with the goal of becoming the go-to oral care brand for millennials and Generation Z.For more information on Bruush Oral Care Inc visit https://bruush.com. This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investing advice. Contact Details TraDigital IR - Colette Eymontt colette@tradigitalir.com Company Website http://www.tradigitalir.com
November 17, 2022 09:15 AM Eastern Standard Time
Digital Asset DirectOTCMKTS : $OCEL 📋 Organicell Activates COPD Trial at Mayo Clinic!
Organicell Regenerative Medicine, Inc.
Contact Details Organicell Investor Relations IR@organicell.com Company Website https://organicell.com/
November 16, 2022 01:20 PM Eastern Standard Time
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News ReleaseIBM and Algorithmiq join forces to pave the way toward useful quantum advantage for quantum chemistry
Algorithmiq
Algorithmiq, a Helsinki-based quantum computing startup, has entered into an engagement with IBM to progress in its exploration of quantum algorithms that attempt to solve complex issues in life sciences. This collaboration brings together IBM's world-leading hardware, software and quantum applications expertise with Algorithmiq's cutting-edge algorithm developers, to explore ways to dramatically cut the time and cost of drug discovery and development. The work will also contribute any work produced to Qiskit, an open-source SDK for quantum computers, with the aim of promoting and developing this nascent ecosystem. As part of the engagement, Algorithmiq will become part of the IBM Quantum Network. IBM’s researchers are collaborating with Algorithmiq to address how to overcome the main bottlenecks in today’s noisy quantum hardware, such as limited speed, accuracy, and scale, for large quantum chemistry simulations. Algorithmiq’s novel measurement techniques have shown to greatly reduce runtime in hybrid quantum-classical algorithms. In addition, Algorithmiq’s post-processing strategies for error mitigation have shown to significantly improve the accuracy of quantum chemistry simulations. Therefore, this collaboration looks to yield promising results to boost the performance of quantum algorithms on near-term quantum technology. Founded by a team of world-leading academics in the field, Algorithmiq is focused on leveraging the power of quantum computing so that new drugs can be explored and eventually brought to market, and cost-effectively, leading to precise medical treatments. On average, it currently takes around a decade and $1 billion for a new drug to get to market. Algorithmiq's advances are estimated to reduce the time-to-market of new, more efficient and less harmful drugs, significantly. Algorithmiq's mission is to prevent and cure diseases by exploiting the power of quantum computing combined with a complex systems approach to drug discovery and development. Sabrina Maniscalco, CEO and co-founder of Algorithmiq: “We are delighted to collaborate with IBM as we look to combine our world-leading quantum algorithms with IBM’s best-in-class hardware and quantum chemistry expertise toward realising the full potential of the technology for quantum chemistry simulations. Quantum computing holds the key to revolutionising the process of drug discovery and development. We couldn’t be more thrilled to be collaborating with a giant of the technology industry in our pursuit of this mission, placing ourselves at the forefront of innovation and the race to prove useful quantum advantage in the space.” Guillermo Garcia Perez, CSO and co-founder of Algorithmiq: “ Whilst unleashing the full power of quantum simulations will likely require fault-tolerant quantum computers, near-term devices like those developed by IBM, combined with our novel algorithms based on informationally complete data, are today already showing progress toward the demonstration of a quantum advantage for chemistry. This is a steppingstone for any application of quantum computers to Life Sciences.” Ivano Tavernelli, Global Leader for Advanced Algorithms for Quantum Simulations, IBM Research: “IBM believes the demonstration of quantum advantage in areas such as quantum chemistry is possible this decade. So, we are excited to collaborate with Algorithmiq in our efforts to push the industry forward, and we are glad to see the promising results they have achieved to date in improving the performance of near-term quantum algorithms. We are glad to support Algorithmiq’s ambition through the IBM Quantum Network, and believe that the company’s work could be pivotal in carving a path towards demonstrating quantum advantage with near-term quantum algorithms.” About Algorithmiq Algorithmiq develops software and quantum algorithms to solve complex issues in life sciences, with the mission to significantly reduce the time and cost it takes for pharma companies to bring new drugs for diseases to market. Based in Helsinki, the company is led by a team of ambitious, world-leading academics in quantum computing and is one of the only software companies specifically focused on optimising algorithms for NISQ to impact the drug discovery pipeline. In February 2022, the startup announced a $4m seed round backed by investment from Tiger Global, K5 Global and numerous angel investors. Alongside Co-Founder and CEO Professor Sabrina Maniscalco on Algorithmiq’s Board are:- Co-Founder and DeepMind advisor Dr Jussi Westergren; Jorma Ollila, former CEO and Chairman of Nokia; and Haakon Overli, founding General Partner at Dawn Capital, who sit on the board. About IBM For more information, visit https://www.ibm.com/quantum Contact Details Algorithmiq Bilal Mahmood +44 7714 007257 b.mahmood@stockwoodstrategy.com Company Website https://algorithmiq.fi/
November 16, 2022 06:00 AM Eastern Standard Time
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News ReleaseAiViva Reports That Their Promising New Treatment For Wet AMD Is Soon To Be Ready For Clinical Trials
AiViva BioPharma
If you would like to learn more about AiViva, check out its website. Visit https://www.startengine.com/aiviva to invest in AiViva’s StartEngine Campaign. Wet age-related macular degeneration, also known as wet AMD, is a chronic eye disorder that causes blurred vision or blind spots in the visual field of the eye. It’s caused by abnormal blood vessels that leak fluid or blood into the eye’s macula and scar it (the macula is the area of the eye that provides the sharp, central vision needed for reading, driving and seeing fine detail). Wet AMD can progressively lead to vision loss resulting in permanent blindness if left untreated, according to report s. Over 45% of patients on current therapies do not achieve meaningful vision gain. Currently there is no cure for wet AMD. Currently available treatment for wet AMD involves frequent injections in the eye. It can be a drawn-out process that takes anywhere from four to 12 weeks so new product development for wet AMD is focused on developing longer-acting effective drugs, which could result in better vision preservation and less frequent trips to the doctor. AiViva BioPharma AiViva BioPharma, a clinical-stage biotech company headquartered in Newport Beach, California, is developing AIV007 in combination with its JEL™ technology – a drug the company says has the potential to address the underlying root cause of vision loss from wet AMD and treat the disease with good clinical outcomes that preserve and enhance vision in patients while reducing visits to the doctor. How Is AiViva’s Drug Different? AiViva’s proprietary JEL™ technology allows for the placement of the drug directly at the site of disease, where it forms a depot for prolonged drug release. A unique feature of AiViva’s JEL™ is that its delivery medium is a liquid at room temperature, which upon injection into the diseased eye tissue at a warmer body temperature quickly hardens into a gelatin-like mass. This drug-infused mass (a drug depot) then serves as a storehouse to release the drug over time to the disease site, effectively preventing blood from leaking into the macula. In addition to stemming fluid or blood leaking, the company reports demonstrating proof of concept of AIV007’s potential to remove scarring within the macula which accounts for long-term vision loss and no current treatment addresses. AIV007 has a unique mechanism of action by targeting multiple key receptors VEGFR, PDGFR, and FGFR, and TGFβ1. These actions collectively and effectively address abnormal growth of leaky blood vessels, underlying inflammation and scarring. Other companies offering maintenance treatment for wet AMD include Ocular Therapeutix Inc. (NASDAQ: OCUL), Eyepoint Pharmaceuticals Inc. (NASDAQ: EYPT), Clearside Biomedical Inc. (NASDAQ: CLSD), Aerie Pharmaceuticals Inc. (NASDAQ: AERI) and Graybug Vision Inc. (NASDAQ: GRAY). The company says that its distinct edge over the competition is its ability of specific drug delivery which currently available treatments do not offer - its precision medicine is advantageous to achieve long local drug action and no systemic toxicity. The characteristics of the JEL™ Technology also allow for the customization of drug-release profiles, easy administration by physicians, optimal drug exposure in target tissues and the development of indication-specific formulations. Owing to these advantageous properties of the drug, AiViva plans to adapt its JEL™ Technology for new treatments in urology, ophthalmology, and oncology. AiViva has a diverse pipeline focused on wet AMD, prostate disorders, scarring, and nonmelanoma skin cancer. It believes AiViva’s JEL™, formulated with suitable active compounds, could potentially be developed for the treatment of many other diseases, including solid tumors. The clinical trial for AIV007 intended for the treatment of wet AMD is expected to commence in 2023. AiViva believes that as far as the treatment of retinal diseases goes, AIV007 in its JEL™ form also could potentially be developed for the treatment of diabetic macular edema, retinal vein occlusion and diabetic retinopathy. An Experienced Team And Patent-Backed Products The company’s web profile highlights a leadership team of seasoned industry experts with a track record in successful drug development and commercialization, who, under the leadership of company President and CEO Diane Tang-Liu, have reportedly brought multiple successful products to the market through Food and Drug Administration (FDA) approval. AiViva boasts a diverse product pipeline it says is expected to address a large, combined market, potentially delivering a combined multibillion-dollar revenue. Its delivery technology and medical uses are protected by strong intellectual property positions with 23 issued product patents and over 40 patents pending worldwide. The company's founders have made multiple initial public offerings (IPOs) on the New York Stock Exchange and the Nasdaq Stock Exchange and a successful reverse merger. AiViva has raised over $30 million, including $10 million raised during 2022. AiViva was rated as a top 20 clinical-stage biopharma company by Life Sciences Review in 2022 and could be one to watch in the transformative treatments in ophthalmology space. Interested in investing in AiViva? Go here. AiViva is a clinical stage biotech company which has created proprietary technology and new treatments to address significant, unmet medical needs in ophthalmology, dermatology, urology, and oncology. The company is led by a team of seasoned industry experts who have an outstanding track record in successful drug development, commercialization, and multiple IPOs on the NYSE and NASDAQ. 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 17(b) disclosure linked in the campaign page for more information. Contact Details Shane Cerrato michael@aiviva.com Company Website https://aiviva.com/
November 15, 2022 03:41 PM Eastern Standard Time
News ReleaseCan This Company’s Positive Results For Psychedelic Combination Treatment Provide Hope For Alcohol And Cocaine Addiction Problems?
SciSparc Ltd.
Learn More about SciSparc Ltd. by gaining access to the latest research report There is a high probability that you may know someone battling some form of addiction. Whether it’s a problem with opioids, alcohol, cocaine, or even using pain meds, an unchecked addiction can be fatal. Addiction, or substance use disorder (SUD), can be a chronic mental health condition that demands urgent attention before it gets out of hand. Take alcohol abuse, for example; the World Health Organization (WHO) estimates that three million deaths yearly result from the harmful use of alcohol. This represents 5.3% of all deaths. Overall, 5.1% of the global burden of disease and injury is attributable to alcohol, as measured in disability-adjusted life years (DALYs). Looking at the overall drug abuse and addiction globally, around 275 million people used drugs worldwide in 2020, while over 36 million people suffered from drug use disorders, according to the 2021 World Drug Report by the United Nations Office on Drugs and Crime (UNODC). Zooming into the U.S., the National Center for Drug Abuse Statistics (NCDAS) estimates that nearly half of all people 12 and older in the U.S. have used an illicit substance at least once. Since 2000, almost one million people have died of a drug overdose. These staggering statistics call for effective therapies and treatment centers to help curb the trend, especially as there are indications that the number of drug users worldwide is likely to climb up to 11% by 2030. Rising awareness about the adverse effects of alcohol and substance abuse, the introduction of new therapies, and increasing rehabilitation centers are expected to fuel the growth of the global substance abuse treatment market. The global substance abuse treatment market was valued at $10.2 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of 8.5% from 2022 to 2031. The market is anticipated to cross $23.1 billion by 2031. Pharmaceutical companies like Amphastar Pharmaceuticals Inc. (NASDAQ: AMPH), Viatris Inc. (NASDAQ: VTRS), SciSparc Ltd. (NASDAQ: SPRC), and BioCorRx Inc. (OTCMKTS: BICX) are advancing research and therapies aimed at serving the needs of the market. SciSparc is a specialty clinical-stage pharmaceutical company focused on developing therapies to treat CNS disorders from a portfolio of technologies and assets based on cannabinoid pharmaceuticals. The company is engaged in drug development programs based on tetrahydrocannabinol (THC) and nonpsychoactive cannabidiol (CBD). The company’s pipeline of product candidates includes SCI-110 for treating Tourette syndrome, Alzheimer’s disease and agitation; SCI-160 for treating pain; and SCI-210 for treating autism spectrum disorder and status epilepticus. It also has CannAmide™, an immediate unique palmitoylethanolamide (PEA) oral formulation for reducing chronic pain and inflammation. Positive Results For Psychedelic Combination Treatment In May this year, SciSparc announced positive efficacy and safety profile results from its joint preclinical trial with Clearmind Medicine Inc. (NASDAQ:CMND,CSE: CMND)), a psychedelic pharmaceutical company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and underserved health problems. The trial tested the proprietary combination of SciSparc’s CannAmide™ with Clearmind’s psychedelic molecule5-Methoxy-2aminoindane ( MEAI ) for suppressing alcohol use disorder. A histopathology assessment was conducted on several organs (heart, lungs, liver, kidneys, brain, pancreas, spleen and thyroid gland) from all experiment groups to determine the safety of the proprietary combination of MEAI and CannAmide™ versus control mice that were not exposed to alcohol. Previously announced successful results showed a significant dose-dependent effect for the MEAI treatment in reducing alcohol consumption in treated animals, with substantial additional effect when combining CannAmide™ with the lower sub-effective MEAI dose. On Aug. 24, the company announced additional positive preclinical results of its psychedelic-based pharma collaboration for treating cocaine addiction using MEAI. These preclinical study results add to the company’s collaboration with Clearmind for its combination treatment for various addictions, including preclinical studies results and filing two provisional patent applications related to compositions comprising MEAI and n-acylethanolamines, their use and treating cocaine addiction. Gal Yadid and his team from the Gonda Multidisciplinary Brain Research Center at Bar Ilan University in Israel led a preclinical trial designed to evaluate the possible reward-like effects of MEAI in connection to cocaine and its ability to abolish cocaine- induced conditioned place preference. The self-administration paradigm, the gold-standard model for examining drug addiction, was used in the preclinical trial. Rats were catheterized and trained to self-administer cocaine. The results identified a statistically significant sub-group that responded dramatically to the treatment, significantly decreasing the craving for cocaine compared to a nontreated control group. Follow the story at SciSparc’s website here. SciSparc Ltd. is a specialty clinical-stage pharmaceutical company led by an experienced team of senior executives and scientists. SciSparc's focus is on creating and enhancing a portfolio of technologies and assets based on cannabinoid pharmaceuticals. With this focus, the Company is currently engaged in the following drug development programs based on THC and/or non-psychoactive cannabidiol (CBD): SCI-110 for the treatment of Tourette Syndrome, for the treatment of Alzheimer's disease and agitation; SCI-160 for the treatment of pain; and SCI-210 for the treatment of autism spectrum disorder and status epilepticus. This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investing advice. Contact Details TraDigital IR- Christine Petraglia christine@tradigitalir.com Company Website https://scisparc.com/
November 15, 2022 10:25 AM Eastern Standard Time
Digital Asset DirectOxford Cannabinoid Technologies nearly ready for new phase 1 trial
Oxford 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 ReleaseWomen’s Healthcare Company Agile Therapeutics Says It Believes It Has An Effective Business Plan In Place For Growth And Generating Positive Cash Flow
Agile 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
