8-K
BioCorRx Inc. (BICX)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): September 1, 2021
| BioCorRx Inc. | ||
|---|---|---|
| (Exact name of registrant as specified in its charter) | ||
| Nevada | 000-54208 | 90-0967447 |
| --- | --- | --- |
| (State or other jurisdiction<br>of incorporation) | (Commission<br>File Number) | (IRS Employer <br>Identification No.) |
| 2390 East Orangewood Avenue, Suite 500<br><br>Anaheim, CA 92806 | ||
| --- | ||
| (Address of principal executive offices) | ||
| (714) 462-4880 | ||
| --- | ||
| (Registrant's telephone number, including area code) | ||
| Not Applicable | ||
| --- | ||
| (Former name or former address, if changed since last report.) |
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| --- | --- |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| N/A | N/A | N/A |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
When used in this Current Report on Form 8-K, unless otherwise indicated, the terms the “Company,” “our,” or “we” refer to BioCorRx Inc. and its subsidiaries.
Item 8.01 Other Items.
On September 1, 2021, the Company announced it had received a Notice of Award from the United States Department of Health and Human Services for the second phase of a grant in the amount of approximately $3,500,000 from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (“NIH”). This phase will include a first-in-human clinical trial of BICX104, an implantable biodegradable naltrexone pellet for the treatment of opioid use disorder, being developed under BioCorRx Pharmaceuticals, Inc., the Company’s controlled research and development subsidiary. The Company has received a total of approximately $5.7 million from NIDA.
On September 1, 2021, the Company issued a press release announcing the events described in this Item 8.01. A copy of the press release is filed as Exhibit 99.1 hereto and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
| Exhibit No. | Description of Exhibit |
|---|---|
| 99.1 | Press Release dated September 1, 2021 |
| 104 | Cover Page Interactive Data File (formatted as inline XBRL). |
| 2 | |
| --- |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| BioCorRx Inc. | |
|---|---|
| Date: September 2, 2021 | /s/ Lourdes Felix |
| Name: Lourdes Felix | |
| Title: Chief Executive Officer | |
| 3 | |
| --- |
bicx_ex991.htm EXHIBIT 99.1
News & Media
BioCorRx Announces Award of Approximately $3.5 Million NIDA Grant for the Clinical Trial of BICX104, its Implantable Naltrexone Pellet for the Treatment of Opioid Use Disorder
On track to commence the first-in-human clinical trial for BICX104
ANAHEIM, CA, Sept. 01, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire --
BioCorRx Inc. (OTCQB: BICX) (the “Company”), a developer and provider of advanced solutions in the treatment of substance use disorders, announced today that it has been awarded approximately $3.5 million for the second phase of a grant which was awarded by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), under award number UG3DA047925. This phase (UH3) will include a first-in-human clinical trial of BICX104, an implantable biodegradable naltrexone pellet for the treatment of opioid use disorder (OUD), being developed under BioCorRx Pharmaceuticals, Inc., the Company’s controlled R&D subsidiary. This notice of award is the result of the Company’s application under RFA DA-19-002, “Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional).” The Company has received a total of approximately $5.7 million for the UG3 phase, announced last year. In May, the Company received clearance from the U.S. Food and Drug Administration (FDA) to proceed to human trials for BICX104. The Company had a previous pre-IND meeting with the FDA, at which time the FDA deemed the abbreviated 505(b)(2) pathway acceptable, as well the opportunity to seek eventual dual indication on the product for OUD and Alcohol Use Disorder (AUD).
| 1 |
|---|
Lourdes Felix, CEO, CFO and Director of BioCorRx Inc., stated, “We have achieved another major milestone for BICX104, a gradual release implantable pellet for opioid use disorder. This award of non-dilutive NIDA grant funding not only builds on the progress we have achieved to date with BICX104, it also substantially covers our financial costs towards FDA approval. We are looking forward to beginning the first-in human clinical trial of BICX104 which will assess longevity, safety, and tolerability of BICX104. We are very excited to move another step closer to bringing BICX104 to market to help people suffering from opioid use disorder. We are striving to begin clinical trials this calendar year if scheduling with our valued partners permits.”
About BioCorRx
BioCorRx Inc. (OTCQB: BICX) is an addiction treatment solutions company offering a unique approach to the treatment of substance use and other related disorders. Beat Addiction Recovery is a substance use disorder recovery program that typically includes BioCorRx’s proprietary Cognitive Behavioral Therapy (CBT) modules along with peer support via mobile app along with medication prescribed by an independent treating physician under their discretion. The UnCraveRx™ Weight Loss Program is also a medication assisted weight loss program; please visit www.uncraverx.com for more information on UnCraveRx™. The Company also conducts R&D under its controlled subsidiary, BioCorRx Pharmaceuticals. For more information on BICX and product pipeline, please visit www.BioCorRx.com.
| 2 |
|---|
Safe Harbor Statement
The information in this release includes forward-looking statements. These forward-looking statements generally are identified by the words "believe," "project," "estimate," "become," "plan," "will," and similar expressions. These forward-looking statements involve known and unknown risks as well as uncertainties. Although the Company believes that its expectations are based on reasonable assumptions, the actual results that the Company may achieve may dijfer materially from any forward-looking statements, which reflect the opinions of the management of the Company only as of the date hereof.
The content presented in this release is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
BioCorRx Inc.
investors@BioCorRx.com
714-462-4880
Investor Relations:
Crescendo Communications, LLC
(212) 671-1020 x304
bicx@crescendo-ir.com
Source: BioCorRx Inc
Released September 1, 2021
Get email alerts
| 3 |
|---|