8-K: Current report
Published on
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 11, 2026
(Exact name of registrant as specified in its charter)
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(State or other jurisdiction of incorporation)
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(Commission File Number)
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(IRS Employer Identification No.)
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(Address of principal executive offices)
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(Zip Code)
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(984 ) 884-6030
(Registrant’s telephone number, including area code)
N/A
(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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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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 7.01 |
Regulation FD Disclosure.
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On September 11, 2026, Opus Genetics, Inc. (the “Company”) issued a revised version of the Company’s data presentation, which
was initially used in connection with its investor conference on September 9, 2026, announcing clinical data from Cohort 1 of the Company’s ongoing Phase 1/2 clinical trial of OPGx-BEST1 in patients with BEST1-related retinal diseases. The
original data presentation was furnished by the Company on a Current Report on Form 8-K on September 9, 2026.
The revised version of the data presentation, which is furnished as Exhibit 99.1 to this Current Report on Form 8-K, corrects
an immaterial error in the translation of logMAR visual acuity into ETDRS letters, which impacted the depiction of mean best-corrected visual acuity from baseline through 3 months in Cohort 1 on Slide 15. The correct three month change from
baseline for each participant is as follows: 101-101 had a 12 letter improvement in the treated eye and a 4 letter improvement in fellow eye, 101-104 had a 1 letter improvement in the treated eye and a 7 letter loss in the fellow eye, 102-101
had a 10 letter loss in the treated eye and an 8 letter loss in the fellow eye, 102-102 had a 2 letter gain in the treated eye and a 5 letter loss in the fellow eye, and 101-106 had a 6 letter gain in the treated eye and a 2 letter gain in the
fellow eye. In addition to the update on Slide 15, high-resolution images of the microperimetry grids for baseline and 3 months were added to the Appendix of the revised presentation for each participant. Individual loci data is available for the
three participants in these images.
| Item 9.01 |
Financial Statements and Exhibits.
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(d) Exhibits
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Exhibit No.
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Description
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99.1
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104
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Cover page from this Current Report on Form 8-K, formatted in Inline XBRL
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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.
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OPUS GENETICS, INC.
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Date:
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September 11, 2026
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By:
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/s/ Dr. George Magrath
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Dr. George Magrath
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| Chief Executive Officer |