Precision BioSciences Inc. filed SEC Form 8-K: Regulation FD Disclosure, Other Events, Financial Statements and Exhibits
$DTIL
Biotechnology: Biological Products (No Diagnostic Substances)
Health Care
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 8-K
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CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 6, 2025
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Item 7.01 Regulation FD Disclosure
On August 6, 2025, Precision BioSciences, Inc. (the “Company”) issued a press release to provide an update on its ELIMINATE-B clinical trial evaluating PBGENE-HBV for hepatitis B. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
Pursuant to General Instruction B.2 of Current Report on Form 8-K, the information contained in, or incorporated into, this Item 7.01 (including the Press Release attached hereto as Exhibit 99.1) of this Form 8-K is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed to be incorporated by reference into any registration statement or other filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 8.01 Other Events
On August 6, 2025, the Company announced Phase 1 safety and efficacy for Cohort 1, the lowest dose level in the ELIMINATE-B clinical trial.
Cohort 1 of the Phase 1 ELIMINATE-B study consisted of three patients each of whom received three planned administrations of 0.2 mg/kg of PBGENE-HBV dosed approximately eight weeks apart.
The primary objective of the ELIMINATE-B study is to characterize the safety of PBGENE-HBV, and the dose in Cohort 1 was selected to maximize the safety margin for first-in-human investigation. PBGENE-HBV was well-tolerated in all three patients in Cohort 1. Across the three patients dosed, none experienced above a Grade 2 treatment-related adverse event, serious adverse event, or dose-limiting toxicity. No clinically significant lab abnormalities were observed.
PBGENE-HBV demonstrated a substantial HBsAg reduction in all three patients in Cohort 1 with best response reductions of 56%, 69% and 47% compared to baseline HBsAg levels (ranging between 562-11,813 IU/mL) in patients one, two and three, respectively. One of three patients (33%) in Cohort 1 achieved a durable HBsAg reduction of approximately 50% from baseline that was maintained as of the data cutoff-date (July 28, 2025), which was seven months after the initial dose of PBGENE-HBV providing evidence of the ability of PBGENE-HBV to drive a durable antiviral response by editing the viral DNA at the source of chronic hepatitis B infection. The other two patients in Cohort 1 demonstrated antiviral response after each dose administration and eventually returned to baseline levels of HBsAg.
Cohort 2 in the ELIMINATE-B study is evaluating PBGENE-HBV at 0.4 mg/kg. As of the data cut off, 1 patient received three dose administrations with two weeks of follow-up, and two patients received one dose administration with four weeks of follow-up. In these patients, no adverse events above Grade 2, no serious adverse events, nor dose-limiting toxicities were observed. There were no clinically significant liver transaminase elevations noted. One additional patient did not complete their dose due to a transient infusion-related serious adverse event that led to dose interruption at minute two. This event quickly resolved within minutes of ceasing the infusion, and the patient is doing well. The Data Monitoring Committee (“DMC”) deemed the event not dose-related or dose-limiting.
The Company is on track to complete dosing of all three patients with all three planned dose administrations in Cohort 2 and commence dosing Cohort 3 and expects to provide a data update later in 2025. In parallel, the DMC recently recommended initiation of Cohort 3 given the favorable safety profile of Cohorts 1 and 2.
Forward-Looking Statements
Statements in this Current Report on Form 8-K regarding management’s future expectations, beliefs, intentions, goals, strategies, plans or prospects are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements regarding the ELIMINATE-B clinical trial and PBGENE-HBV program, expectations about operational initiatives, strategies, further development, or timing of additional updates or data releases of PBGENE-HBV, including timing of dose administrations and subsequent cohorts in the ELIMINATE-B trial. Forward-looking statements may be identified by words such as “anticipates,” “believe,” “continue,” “expect,” “intend,” “may,” “plan to,” “potential,” “projects,” “will,” and other similar words or expressions, or the negative of these words or similar words or expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors, including, without limitation, the risks referred to under the section “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2025, as such factors may be updated from time to time in the Company’s other filings with the Securities and Exchange Commission (“SEC”), which filings are accessible on the SEC’s website at www.sec.gov and the Investors & Media page of the Company’s website at https://
investor.precisionbiosciences.com. All forward-looking statements speak only as of the date of this Current Report on Form 8-K and, except as required by applicable law, we have no obligation to update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
Item 9.01 Financial Statements and Exhibits.
(d)Exhibits
| Exhibit No. | Description | |||||||
| 99.1 | ||||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |||||||
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.
| PRECISION BIOSCIENCES, INC. | |||||||||||
| Date: | August 6, 2025 | By: | /s/ John Alexander Kelly | ||||||||
John Alexander Kelly Chief Financial Officer | |||||||||||