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PRECISION BIOSCIENCES INC

For the period ended Mar 26, 2025. Filed Mar 26, 2025.

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A notice of a major event between regular reports, such as results, a deal or a change of executives. It is often the first formal record of the news.

Mar 26, 2025 · Filed Mar 26, 2025

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EX-99.1 · Forward-Looking Statements

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the clinical development and expected safety, efficacy and benefit of our and our partners’ and licensees’ product candidates and gene editing approaches including editing efficiency, and the suitability of ARCUS nucleases for gene insertion, gene elimination and gene excision and differentiation from other gene editing approaches; the expected timing of regulatory processes and clinical operations (including filings, studies, enrollment and clinical data for PBGENE-HBV, PBGENE-3243 and iECURE OTC); the design of PBGENE-HBV to directly eliminate cccDNA and inactivate integrated HBV DNA with high specificity, potentially leading to functional cures; clinical data suggesting that PBGENE-HBV appears to be working by its intended mechanism of eliminating the source of viral replication in cccDNA while inactivating integrated disease; plans to provide ongoing updates on the full low-dose cohort for the PBGENE-HBV study, including multiple dose administrations, and data at higher dose levels throughout 2025; the ability of ARCUS single-component nucleases to penetrate the mitochondrial membranes; the high specificity of ARCUS nucleases enables editing and elimination of mutant mitochondrial DNA while allowing wild-type (normal) mitochondrial DNA to repopulate, thus improving cellular function; plans to present new data for PBGENE-3243 in 2025 while advancing the program toward a CTA and/or IND; the ability of PBGENE-DMD to provide significant functional dystrophin protein production across heart, diaphragm and skeletal muscles at levels expected to provide therapeutic benefit in a humanized DMD-diseased mouse model; the ability of PBGENE to edit satellite muscle stem cells, a potential predictor of durable functional benefit; the translation of results in preclinical studies of ARCUS nucleases to clinical studies in humans; expectations about our and our partners’ operational initiatives, strategies, and further development of our programs; expectations and updates around our partnerships and collaborations and our ability to enter into new collaborations, license agreements or other arrangements; our expected cash runway and available credit; the sufficiency of our cash runway extending into the second half of 2026 and realizing Phase 1 clinical data for multiplein vivo gene editing programs; expectations about achievement of key milestones and receipt of any milestone, royalty, or other payments; expectations regarding our liquidity and capital resources; and anticipated timing of clinical data . In some cases, you can identify forward-looking statements by terms such as “aim,” “anticipate,” “appear,” “approach,” “believe,” “contemplate,” “could,” “designed,” “estimate,” “expect,” “goal,” “intend,” “look,” “may,” “mission,” “plan,” “possible,” “potential,” “predict,” “project,” “pursue,” “should,” “strive,” “suggest,” “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. These 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 important factors, including, but not limited to, our ability to become profitable; our ability to procure sufficient funding to advance our programs; risks associated with our capital requirements, anticipated cash runway, requirements under our current debt instruments and effects of restrictions thereunder, including our ability to raise additional capital due to market conditions and/or our market capitalization; our operating expenses and our ability to predict what those expenses will be; our limited operating history; 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 dependence on our ARCUS technology; the initiation, cost, timing, progress, achievement of milestones and results of research and development activities and preclinical and clinical studies, including clinical trial and investigational new drug applications; public perception about genome editing technology and its applications; competition in the genome editing, biopharmaceutical, and biotechnology fields; our or our collaborators’ or other licensees’ ability to identify, develop and commercialize product candidates; pending and potential product liability lawsuits and penalties against us or our collaborators or other licensees related to our technology and our product candidates; the U.S. and foreign regulatory landscape applicable to our and our collaborators’ or other licensees’ development of product candidates; our or our collaborators’ or other licensees’ ability to advance product candidates into, and successfully design, implement and complete, clinical trials; potential manufacturing problems associated with the development or commercialization of any of our product candidates; delays or difficulties in our and our collaborators’ and other licensees’ ability to enroll patients; changes in interim “top-line” and initial data that we announce or publish; if our product candidates do not work as intended or cause undesirable side effects; risks associated with applicable healthcare, data protection, privacy and security regulations and our compliance therewith; our or our licensees’ ability to obtain orphan drug designation or fast track designation for our product candidates or to realize the expected benefits of these designations; our or our collaborators’ or other licensees’ ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions, limitations and/or warnings in the label of an approved product candidate; the rate and degree of market acceptance of any of our product candidates; our ability to effectively manage the growth of our operations; our ability to attract, retain, and motivate executives and personnel; effects of system failures and security breaches; insurance expenses and exposure to uninsured liabilities; effects of tax rules; effects of any pandemic, epidemic, or outbreak of an infectious disease; the success of our existing collaboration and other license agreements, and our ability to enter into new collaboration arrangements; our current and future relationships with and reliance on third parties including suppliers and manufacturers; our ability to obtain and maintain intellectual property protection for our technology and any of our product candidates; potential litigation relating to infringement or misappropriation of intellectual property rights; effects of natural and manmade disasters, public health emergencies and other natural catastrophic events; effects of sustained inflation, supply chain disruptions and major central bank policy actions; market and economic conditions; risks related to ownership of our common stock, including fluctuations in our stock price; our ability to meet the requirements of and maintain listing of our common stock on Nasdaq or other public stock exchanges; and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 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 atwww.sec.gov and the Investors page of our website under SEC Filings atinvestor.precisionbiosciences.com.

All forward-looking statements speak only as of the date of this press release 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.

Precision Biosciences, Inc.
Statements of Operations
(In thousands, except share and per share amounts)
For the Three Months Ended December 31,
20242023
Revenue$638$7,038
Operating expenses
Research and development15,90713,389
General and administrative9,5778,539
Total operating expenses25,48421,928
Operating loss(24,846)(14,890)
Other income (expense):
Loss from equity method investment(972)(871)
(Loss) gain on changes in fair value(659)1,603
Gain on change in fair value of warrant liability7,812—
Interest expense(392)(579)
Interest income1,4941,827
Loss on disposal of assets(182)(524)
Total other income7,1011,456
Loss from continuing operations$(17,745)$(13,434)
Loss from discontinued operations—(2,855)
Net loss$(17,745)$(16,289)
Net loss per share-basic and diluted$(2.22)$(4.06)
Weighted average shares of common stock outstanding-basic and diluted7,999,2884,010,067
Precision Biosciences, Inc.
Statements of Operations
(In thousands, except share and per share amounts)
For the Years Ended December 31,
20242023
Revenue$68,696$48,727
Operating expenses
Research and development59,55953,375
General and administrative35,29939,088
Total operating expenses94,85892,463
Operating loss(26,162)(43,736)
Other income (expense):
Loss from equity method investment(1,084)(4,931)
Gain on changes in fair value2581,145
Gain on change in fair value of warrant liability29,610—
Interest expense(1,782)(2,230)
Interest income6,7637,686
Loss on disposal of assets(436)(461)
Total other income33,3291,209
Income (loss) from continuing operations$7,167$(42,527)
Loss from discontinued operations (including gain on disposal of $8,446 during the year ended December 31, 2023)—(18,792)
Net income (loss)$7,167$(61,319)
Net income (loss) per share
Basic$1.05$(15.96)
Diluted$1.04$(15.96)
Weighted-average shares of common stock outstanding
Basic6,832,9823,841,405
Diluted6,883,9113,841,405
Precision Biosciences, Inc.
Balance Sheets Data
(In thousands, except share amounts)
December 31, 2024December 31, 2023
Cash, cash equivalents, and restricted cash$108,468$116,678
Working capital80,00986,372
Total assets136,388159,781
Total liabilities79,995140,920
Total stockholders' equity$56,393$18,861
Common stock outstanding8,202,7154,164,038
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