Current Report Filing (8-k)
February 23 2022 - 9:31AM
Edgar (US Regulatory)
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0001353406
2022-02-21
2022-02-21
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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): February 21, 2022
REDHAWK
HOLDINGS CORP.
(Exact
name of registrant as specified in its charter)
Nevada |
000-54323 |
20-3866475 |
(State or other jurisdiction
of incorporation) |
(Commission File Number) |
(Employer Identification
No.) |
|
|
|
100 Petroleum Drive, Suite 200,
Lafayette,
Louisiana 70508 |
(Address
of principal executive offices) (Zip Code) |
Registrant’s
telephone number, including area code: (337)
269-5933
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: None.
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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
1.01 |
Entry
into Material Definitive Agreement. |
The
Registrant announced today that it now offers for sale certain real time SARS-CoV2-RT-PCR clinical tests (“Clinical Test Kits”)
and SARS-CoV-2 Antigen Rapid Self Tests (“Home Test Kits”). The Clinical Test Kits and Home Test Kits offered for sale have
received Emergency Use Authorization from the United States Food and Drug Administration (“FDA EUA”).
COVID-19
is a respiratory disease caused by infection with SARS-CoV-2 virus. Common signs of infection include respiratory symptoms, fever, cough,
breathing difficulties. In severe cases, infection can cause pneumonia, severe acute respiratory syndrome, kidney failure and death.
The
Clinical Test Kits, manufactured in the United States, are intended for the qualitative detection of nucleic acid from the SARS-CoV-2
in nasopharyngeal swabs, oropharyngeal swabs and sputum from patients suspected of COVID-19
by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988
(CLIA), 42 U.S.C. §263a, to perform high complexity tests.
The
Clinical Test Kits are a real-time reverse transcription polymerase chain reaction test that includes the assays and controls for a real
time RT-PCR test for the qualitative detection of RNA from SARS-CoV-2 in nasopharyngeal swab, oropharyngeal swab and sputum specimens
from patients who are suspected of COVID-19.
Results
are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in sputum and upper respiratory specimens during
the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history
and other diagnostic information is necessary to determine patient infective status.
The
Clinical Test Kits are intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in
the techniques of real-time PCR and in vitro diagnostic procedures.
The
Home Test Kits are one-step lateral flow chromatographic immunoassay. The test strip in the device includes: (i) a conjugate pad containing
anti-SARS-CoV-2’s Nucleocapsid protein antibody, Mouse IgG antibody, all of which are conjugated to colloidal gold, and (ii) nitrocellulose
membrane containing a test line (“T-line”) and a control line (“C-line”).
The
T-line is coated with anti-SARS-CoV-2’s Nucleocapsid protein antibody, when the specimen is added, it migrates by capillary diffusion
rehydrating the gold conjugate, if present in the specimen, SARS-CoV-2’s Nucleocapsid protein and its antibody labeled with colloidal
gold formed antigen-antibody complexes. These complexes will continue to migrate along the strip until the T-line, where they are captured
by the SARS-CoV-2’s Nucleocapsid protein antibody generating a red violet line in T-line. If the specimen does not contain SARS-CoV-2
or the SARS-CoV-2 is below the lower level, the T-line will not appear.
The
C-line is coated with Goat anti-Mouse IgG which should bind to the gold-Mouse IgG antibodies conjugate and form a red violet line regardless
of the presence of SARS-CoV-2’s Nucleocapsid protein.
The
purchase of the Clinical Test Kits and the Home Test Kits is subject to certain terms and conditions including, but not limited to, product
inspection, product testing, and acceptance. The agreement to purchase the Clinical Test Kits and the Home Test Kits is cancelable, among
other things, upon the occurrence of material adverse changes in market conditions or the manufacturer’s loss of its FDA EUA.
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.
|
REDHAWK HOLDINGS CORP. |
|
|
Date: February 23, 2022 |
By: |
/s/
G. Darcy Klug |
|
|
G. Darcy Klug |
|
|
Chief Financial Officer |
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