Precision BioSciences Inc. filed SEC Form 8-K: Results of Operations and Financial Condition, Regulation FD Disclosure, Other Events, Financial Statements and Exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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FORM
CURRENT REPORT
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Item 2.02 Results of Operations and Financial Condition.
Although it has not finalized its full financial results for the quarter ended September 30, 2024, Precision BioSciences, Inc. (the “Company”) expects to report that it had approximately $121 million in cash, cash equivalents, and restricted cash as of September 30, 2024. This estimate is unaudited and preliminary and does not present all information necessary for an understanding of the Company’s financial condition as of September 30, 2024, and its results of operations for the quarter ended September 30, 2024. The review of the Company’s financial statements for the quarter ended September 30, 2024 by the Company’s independent registered public accounting firm is ongoing and could result in changes to the information set forth above.
Item 7.01 Regulation FD Disclosure.
On October 24, 2024, the Company issued a press release announcing it has received clinical trial application (“CTA”) clearance in Moldova for its lead candidate, PBGENE-HBV for the treatment of chronic hepatitis B. A copy of the press release, which is attached to this Current Report on Form 8-K as Exhibit 99.1, is furnished pursuant to this Item 7.01.
The information under this Item 7.01 (including Exhibit 99.1 hereto) and Item 2.02 of this Current Report on Form 8-K is not deemed “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section. Registration statements or other documents filed with the SEC shall not incorporate this information by reference, except as otherwise expressly stated in any such filing.
Item 8.01 Other Events.
On October 24, 2024, the Company announced its CTA for its wholly owned in vivo gene editing program PBGENE-HBV was accepted in Moldova.
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this Current Report on Form 8-K that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding our expected cash, cash equivalents and restricted cash balances, the clinical development and expected efficacy and benefit of our product candidates, the expected timing and updates of regulatory processes, expectations about our operational initiatives and business strategy, and expectations about achievement of key milestones. In some cases, you can identify forward-looking statements by terms such as “aim,” “anticipate,” “approach,” “believe,” “designed to”, “contemplate,” “could,” “estimate,” “expect,” “goal,” “intend,” “look,” “may,” “mission,” “plan,” “possible,” “potential,” “predict,” “project,” “pursue,” “should,” “target,” “will,” “would,” or the negative thereof and similar words and expressions. Forward-looking statements are based on management’s current expectations, beliefs and assumptions and on information currently available to us. Such statements are neither promises nor guarantees, and involve a number of known and unknown risks, uncertainties and assumptions, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, without limitation, our ability to procure sufficient funding or other partnership opportunities to advance our programs on terms that are acceptable to us, or at all, the progression and success of our programs and product candidates in which we expend our resources; our limited ability or inability to assess the safety and efficacy of our product candidates; the risk that other genome-editing technologies may provide significant advantages over our ARCUS technology; our or our collaborators’ or other licensees’ ability to advance product candidates into, and successfully design, implement and complete, clinical trials; the success of our existing collaboration agreements, and our ability to enter into new collaboration arrangements; and the other risks referred to under the section “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, as any such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov and the Investors page of our website under SEC Filings at 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.
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Exhibits |
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Exhibit |
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Description |
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99.1 |
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Press release of Precision BioSciences, Inc. dated October 24, 2024. |
104 |
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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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PRECISION BIOSCIENCES, INC. |
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Date: |
October 24, 2024 |
By: |
/s/ John Alexander Kelly |
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John Alexander Kelly Chief Financial Officer |