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 5, 2018
ARCH THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
| Nevada | 000-54986 | 46-0524102 |
| (State or other jurisdiction | (Commission | (I.R.S. Employer |
| of incorporation) | File Number) | Identification No.) |
| 235 Walnut Street, Suite 6 | |
| Framingham, Massachusetts | 01702 |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code: (617) 431-2313
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 (see General Instruction A.2. below):
| ¨ | 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)) |
|
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. ¨ | |
| Item 7.01 | Regulation FD Disclosure. |
On September 5, 2018, Arch Therapeutics, Inc. (the “Company”) issued a press release to provide the Topline results for its human skin sensitization study. The text of the press release is attached hereto as Exhibit 99.1 and is incorporated by reference herein.
| Item 8.01 | Other Events. |
The disclosure under Item 7.01 (Regulation FD Disclosure) is incorporated herein by reference.
| Item 9.01 | Financial Statements and Exhibits |
(d) The following exhibits are being filed herewith:
| Exhibit | Description | |
| 99.1 | Press Release issued by Arch Therapeutics, Inc. on September 5, 2018 |
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.
| ARCH THERAPEUTICS, INC. | |||
| Dated: September 5, 2018 | By: | /s/ Terrence W. Norchi, M.D. | |
| Name: Terrence W. Norchi, M.D. | |||
| Title: President, Chief Executive Officer | |||
Exhibit 99.1
Arch Therapeutics Reports Topline Results from Skin Sensitization Study of AC5
Study finds no evidence of irritation or allergic reaction in any enrolled subject
FRAMINGHAM, Mass., September 5, 2018 (GLOBE NEWSWIRE) -- Arch Therapeutics, Inc. (OTCQB: ARTH) ("Arch" or the "Company"), developer of liquid, gel and solid hemostatic and wound care devices, today announced topline data for its irritation/sensitization patch test study of AC5ä Topical Gel (AC5)1. The study was designed to address a request by the Food and Drug Administration (FDA or “the Agency”).
These topline results indicate that AC5 is neither an irritant nor a sensitizer. Additionally, no immunogenic response and no serious or other adverse events attributable to the device were reported in any of the enrolled subjects.
The objective of this Study (“Cumulative Irritancy Assay with Delayed Challenge for Allergic Contact Dermatitis Potential of AC5™ Topical Gel (AC5) in Healthy Volunteers”) was to assess irritation and sensitization potential (development of allergic contact dermatitis) of AC5 after repeat applications and then a delayed challenge application of the product to the skin. Products can be studied in this way to determine if a reaction develops immediately upon initial exposure to the skin, in the case of irritation, or when the skin is ‘challenged’ or exposed again at a point in the future, in the case of allergic contact dermatitis.
Terrence W. Norchi, MD, President and CEO of Arch, said, “We are pleased that these topline results provide favorable support for the safety profile of AC5, and we are eager to provide the full report to the FDA. As previously indicated, this study is intended to strengthen and enhance the Company’s 510(k) notification for AC5 Topical Gel, which we expect to file during this third quarter of calendar 2018, as previously disclosed.”
About Arch Therapeutics, Inc.
Arch Therapeutics, Inc. is a biotechnology company developing a novel approach to stop bleeding (hemostasis), control leaking (sealant)
and manage wounds during surgery, trauma and interventional care. Arch is developing products based on an innovative self-assembling
barrier technology platform with the goal of making care faster and safer for patients. Arch's development stage product candidates
include AC5™ Topical Gel and AC5™ Surgical Hemostatic Device.
Notice Regarding Forward-Looking Statements
This news release contains "forward-looking statements" as that term is defined in Section 27A of the Securities Act
of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Statements in this press release that
are not purely historical are forward-looking statements and include any statements regarding beliefs, plans, expectations or intentions
regarding the future. Such forward-looking statements include, among other things, references to novel technologies and methods,
our business and product development plans and projections, or market information. Actual results could differ from those projected
in any forward-looking statements due to numerous factors. Such factors include, among others, the inherent uncertainties associated
with developing new products or technologies and operating as a development stage company, our ability to retain important members
of our management team and attract other qualified personnel, our ability to raise the additional funding we will need to continue
to pursue our business and product development plans, our ability to obtain required regulatory approvals, our ability to produce
commercial quantities of our products within projected timeframes, our ability to develop and commercialize products based on our
technology platform, and market conditions. These forward-looking statements are made as of the date of this news release, and
we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from
those projected in the forward-looking statements. Although we believe that any beliefs, plans, expectations and intentions contained
in this press release are reasonable, there can be no assurance that any such beliefs, plans, expectations or intentions will prove
to be accurate. Investors should consult all of the information set forth herein and should also refer to the risk factors disclosure
outlined in the reports and other documents we file with the SEC, available at www.sec.gov.
Source: Arch Therapeutics, Inc.
Contact
ARTH Investor Relations
Toll Free: +1-855-340-ARTH (2784) (US and Canada)
Email: investors@archtherapeutics.com
Website: www.archtherapeutics.com
or
Richard Davis
Chief Financial Officer
Arch Therapeutics, Inc.
Phone: 617-431-2308
Email: rdavis@archtherapeutics.com
Website: www.archtherapeutics.com
| 1. | AC5 is currently an investigational device and is limited by federal law to investigational use. |