BioCorRx on growth fast track with robust pipeline, programs for substance use disorders, and weight loss

Working to create a naltrexone implant, BICX102, to help people kick their addiction to opioids and alcohol Licenses its BioCorRx Recovery Program, a MAT program for substance use disorders to healthcare providers and clinics UnCraveRx combines an app that provides fitness and group support with anti-craving medication from independent medical practices  What BioCorRx does: BioCorRx Inc (OTCMKTS:BICX), the Anaheim, California-based healthcare company develops advanced treatment solutions for addiction, weight loss, and other related disorders. It is led by Brady Granier, CEO and president of BioCorRx, who was born in the heart of Cajun Country in Louisiana where he started working at the age of 11 to support his single mother and younger brother. It's personal for Granier, who has family members with addiction in their past. He has worked as a nurse in the emergency room at White Memorial Hospital in Los Angeles. Granier has sharpened BioCorRx’s focus on providing alcohol and opioid addiction treatment programs to rehab centers in the US. Through its subsidiaries, the company licenses the BioCorRx Recovery Program, a medication-assisted treatment (MAT) program for substance use to healthcare providers and clinics. The first component of the program consists of an outpatient implant procedure prescribed and performed by a physician. The implant delivers naltrexone which reduces cravings for alcohol and opioids. It can also be used by those receiving other forms of MAT, such as injectable naltrexone or buprenorphine. Secondly, the program relies on behavioral therapy modules and peer-support built around the use of medications for treating substance use disorder. Similarly, the 12-week UnCraveRx Weight Loss Program combines a sustained-release anti-craving medication with a virtual concierge app that provides access to on demand virtual fitness, nutrition and lifestyle group support. The company conducts R&D under its subsidiary BioCorRx Pharmaceuticals. It is developing BICX101, an extended-release injectable naltrexone product, and an implant, named BICX102 that will help people fight their addiction to both opioids and alcohol. The BICX102 implant uses naltrexone, a drug already approved by the FDA, as an every-day pill or a once-per-month shot. Naltrexone blocks receptors in the brain so that opioids or alcohol become less appealing. BICX102 will be surgically implanted in a person's stomach fat and dissolve slowly over three months, not needing to be removed as it’s completely adsorbed by the body. How is it doing: In December, BioCorRx touted early preclinical data for drug candidate VDM-001, that suggests it may prevent overdose from fentanyl. The drug, developed in partnership with VDM Biochemicals, could represent an alternative to naloxone in the overdose reversal market. In 2017 alone, 28,400 people died of overdoses from synthetic opioids such as fentanyl in the US. Experts say America is in the throes of an opioid epidemic. Nearly 23.5 million Americans are addicted to drugs, alcohol and misuse opioids, according to the Substance Abuse and Mental Health Services Administration. As a result, the over $40 billion addiction treatment market is seeking radical transformation in the shape of effective new treatments. BioCorRX is leading the change by offering a two-pronged approach to the treatment of substance abuse addiction. Medication-assisted treatment (MAT) — the use of medication combined with counselling and behavioral therapies — which is the BioCorRx method, is one of the major pillars of the federal response to the opioid epidemic in America. In a positive sign, BioCorRx received a $5.7 million grant from the National Institute on Drug Abuse (NIDA) for the development of BICX102. It will last two years, which the company says will fund the research through the development of the implant and some early testing. The grant validates the clinical potential of BICX102 which has several potential advantages over other medications used for treatment of substance use disorder. One, is that it fully biodegrades, eliminating the need to remove and replace it as seen with other implants. It also should maintain therapeutic plasma levels for up to three months, said the company, while future versions are expected to last longer. The company’s goal is to give a person a longer time period to address the underlying reasons for their disorder without the intrusive cravings interfering. BioCorRx is seeking a more rapid and cost-effective 505(b)(2) regulatory pathway for its naltrexone implant. Towards that end, it has partnered with IRISYS to manufacture and develop BICX102. The company has a master services agreement with Charles River Laboratories which is conducting preclinical studies of BICX102. If things go according to plan, the company aims to start human studies later this year. In April last year, the company raised $6 million at a premium to its market price from two investors. The company has also been backed by Alpine Creek Capital which first invested $2.5 million when BioCorRx had a market cap of just $3 million. Alpine Creek Capital followed up their initial investment with an additional tranche in the first quarter of 2017. BioCorRx said a senior secured convertible promissory note of $4.16 million with BICX Holding, an entity controlled by Alpine Creek Capital, was recently converted into 2.22 million shares of common stock in order to simplify the company's capital structure and boost its balance sheet. Significantly, the timely conversion eliminated $4.16 million of liabilities from the company’s balance sheet.  Inflection points: BioCorRX’s goal is to get Investigational New Drug approval from the FDA to go into human trials of BICX102, it's lead pipeline candidate in 2020 The UnCraveRx Weight Loss Program is likely to be a key revenue driver as it expands its provider network  New studies are being done to gain insight into the mechanism of action of VDM-001 which holds significant potential to become a major lifesaving drug and impact the lives of many people affected by the opioid epidemic BioCorRx is eying a Nasdaq listing and has enhanced its capital structure and improved its balance sheet to prepare for the planned up-listing which will give the company access to a wider investor base What the boss says: In an interview with Proactive, BioCorRx Inc CEO Brady Granier said: “We have a clean balance sheet, no toxic loans, strong management, independent board, strategic investors, products/programs that do work, government funding for R&D. We operate lean and are poised for growth.” He added: “We feel undervalued based on the accomplishments of this year alone with raising funds at a premium to market plus the NIDA grant award. We raised about $6-$7 million in the last year alone at a premium.” Contact the author Uttara Choudhury at uttara@proactiveinvestors.com Follow her on Twitter: @UttaraProactive