BICX: Pivotal trial underway
OTC:BICX
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After several years of research and preparation, subject enrollment and dosing is underway in the clinical trial of BioCorRx’s (OTC:BICX) subcutaneous naltrexone pellet (BICX104) for the treatment of opioid use (OUD) and alcohol use (AUD) disorders under the US FDA 505(b)(2) pathway. The phase 1, six-month open label trial is enrolling 24 healthy volunteers. The study will measure local safety and pharmacokinetics. The first subject was dosed at the end of June 2022. As a precaution, the patients are being enrolled and dosed in a staggered manner to better assess safety.
Patients in the experimental arm are receiving a one time dose of the BICX104, subcutaneous naltrexone implant and monitored for 84 days. Patients in the active comparator arm will receive Vivitrol intramuscular injection containing 380 mg of naltrexone. Three consecutive doses will be administered once every 28 days for 84 days. The trial will compare patients in both arms on pharmacokinetic parameters (drug and plasma levels of naltrexone over time) and safety (primarily incidence and severity of adverse events related to implantation). BioCorRx expects a full readout in early 2023, with regulatory filing possible the same year. Interim readouts are possible.
BioCorRx will devote the next few years to seeking approval for BICX104, working to gain payer reimbursement for its addiction treatment program and building out sales of UnCraveRx, for weight management. During the next two years, we expect catalysts to come from several areas:
• Clinical milestones for BICX104 and progress towards filing for FDA approval.
• Public health and policymaker actions to educate the public and providers on the benefits of MAT
• Expanded access to MAT in office-based settings
• Fewer hurdles to insurance reimbursement for MAT in both private and public payer programs
We are lowering our near-term expectations for BioCorRx based on management’s focus towards completing its clinical trial and filing for regulatory approval of the BICX104.
For 2022, our revenue assumption is now $39,600, down from $66,000. Our new earnings estimate is $(0.19) from $(0.57) driven entirely by lower revenues, higher grant revenues ($5 million vs. our previous estimate of $3.5 million) on largely stable expenses. We expect largely similar results for 2023. Our 2023 revenue estimate is now $51,800, down from $403,000, and we look for earnings of $(0.07), compared with our previous estimate of $(0.76). The change in earnings is based higher expectations for the UnCraveRx weight management program 2022, and the resulting step-up in related royalty fees, partially offset by a $2 million increase in grant revenues compared to our previous estimate.
Our valuation model is based on the BICX104 implant, addiction recovery program, and UnCraveRx weight management program in the US market. For 2024, we forecast product sales of $1.7 million, growing to $4.8 million by 2025. We’ve modeled BICX104 product sales at $34 million and UnCraveRx sales of $1.2 million by 2031.
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