Press Release: Precision BioSciences Completes Strategic...

Press Release: Precision BioSciences Completes Strategic Transaction with Imugene forAzer-Cel in CancerPrecision BioSciences Completes Strategic Transaction with Imugene for Azer-Cel in Cancer - Precision Eligible to Receive up to $227 Million in Upfront Economics and MilestonePayments for Azer-Cel in Addition to Double-Digit Royalties on Sales - Imugene to Assume Control of Precision's Cell Therapy Infrastructure in Pursuit ofBiologics License Application for Azer-Cel in LBCL Patients who Relapse Following CAR TTreatment - Upfront Cash and Reduced Operating Expenses Extend Precision's Expected Cash Runwaythrough Q3 2025 as the Company Pivots to Focus on In Vivo Gene Editing DURHAM, N.C.--(BUSINESS WIRE)--August 15, 2023-- Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing companydeveloping ARCUS(R)-based in vivo gene editing therapies, today announced completion of astrategic transaction with Imugene Limited (ASX: IMU) for global rights to AzercabtageneZapreleucel (azer-cel), Precision's lead allogeneic CAR T candidate, for cancer. Imugenewill assume ongoing clinical execution for azer-cel in the large B-cell lymphoma (LBCL)population who have relapsed following autologous CAR T treatment. The license alsoincludes an option to develop up to three other cancer research programs in the future. "We are excited to reach this key inflection point for Precision BioSciences with theachievement of three milestones -- first, the completion of a global deal with Imugenefor azer-cel in cancer; second, the extension of our expected cash operating runway togreater than two years; and third, our pivot to focus exclusively on in vivo geneediting, " said Michael Amoroso, Chief Executive Officer at Precision BioSciences. "Weare very pleased to partner with Imugene as they plan to leverage azer-cel's clinicaldata package and recent regulatory feedback to continue its path toward a pivotal trialin LBCL and potentially help patients in dire need. Our commercial and scientificinterests are closely aligned, and we believe Precision's allogeneic CAR T technology cancomplement the novel oncology approaches being pursued by Imugene, especially itsOnCARlytics platform for solid tumors." "After an extensive review of the allogeneic CAR T landscape, we are excited toprogress what we believe is the most advanced allogeneic CAR T program -- azer-cel, whichhas regulatory feedback and a broad data set. This is an important opportunity to developa much-needed treatment for the growing number of lymphoma patients who have relapsedfollowing CAR T treatment and is complementary to our pipeline, which is designed tounleash the immune system to fight cancer, including our OnCARlytics program," saidLeslie Chong, Chief Executive Officer and Managing Director at Imugene Limited. In exchange for global rights to azer-cel for cancer, as well as Precision BioSciences'CAR T infrastructure and its experienced cell therapy teams, Precision will receiveupfront economics valued at $21 million (all figures in USD) consisting of cash andequity. In addition, Precision is eligible for an $8 million near-term payment in cashand equity upon successful completion of the phase 1b dosing in the CAR T relapsed LBCLpatient population. For azer-cel, Precision is eligible to receive up to $198 million inadditional milestone payments and double-digit royalties on net sales. For eachadditional research program selected by Imugene, Precision is eligible for up to $145million in milestone payments and tiered royalties on net sales. Precision's PBCAR19B stealth cell and its CAR T assets targeting multiple myeloma, aswell as all rights to non-oncology indications for azer-cel, remain available fordevelopment through partnership only. Corporate & Financial Update As a result of this transaction, Precision expects to reduce its annual operating spendby approximately $20 million from the current base case and has right-sized the companyto operate as a single platform company focused on in vivo gene editing. Upfront cashfrom this transaction, reduced CAR T operating expenses, and continued fiscal disciplineare expected to extend Precision's cash runway through the third quarter of 2025. "As we pivot our full attention and resources to leveraging the core features of ARCUSfor differentiated in vivo gene editing programs, we are prepared to capitalize on theutility of ARCUS to produce a profound impact on diseases in the liver and beyond,including those that are best suited for gene insertion or excision of large defectivegene sequences. We look forward to providing additional updates about our in vivo geneediting progress at our upcoming R&D event on September 12, 2023," added Mr. Amoroso. About Precision BioSciences, Inc. Precision BioSciences, Inc. is a clinical stage biotechnology company dedicated toimproving life (DTIL) with its novel and proprietary ARCUS(R) genome editing platform.ARCUS is a highly precise and versatile genome editing platform that was designed withtherapeutic safety, delivery, and control in mind. Using ARCUS, the Company's pipelineconsists of several in vivo gene editing candidates designed to cure genetic andinfectious diseases where no adequate treatments exist. For more information aboutPrecision BioSciences, please visit www.precisionbiosciences.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of thePrivate Securities Litigation Reform Act of 1995. The Company intends suchforward-looking statements to be covered by the safe harbor provisions forforward-looking statements contained in Section 27A of the Securities Act of 1933, asamended, and Section 21E of the Securities Exchange Act of 1934, as amended. Allstatements contained in this press release that do not relate to matters of historicalfact should be considered forward-looking statements, including, without limitation,statements regarding the clinical development and expected safety, efficacy and benefitof our product candidates (including azer-cel) and gene editing approaches includingediting efficiency and differentiating aspects; the suitability of ARCUS nucleases forgene insertion, large gene deletion, and other complex gene editing approaches; theexpected timing of regulatory processes; expectations about our operational initiativesand business strategy; expectations around partnership opportunities; our expected cashrunway; expectations about achievement of key milestones and receipt of any milestone,royalty, or other payments; expected cash savings from the transaction with Imugene;expectations regarding our liquidity and capital resources; and the timing of ourupcoming R&D event. The words "aim," "anticipate," "approach," "believe," "contemplate,""could," "estimate," "expect," "goal," "intend," "look," "may," "mission," "plan, ""possible," "potential," "predict," "project," "promise," "pursue," "should," "target,""will," "would," and other similar words or expressions, or the negative of these wordsor similar words or expressions, are intended to identify forward-looking statements,though not all forward-looking statements use these words or expressions. Forward-looking statements are based on management's current expectations, beliefs andassumptions and on information currently available to us. These statements are neitherpromises nor guarantees, but involve number of known and unknown risks, uncertainties andassumptions, and actual results may differ materially from those expressed or implied inthe forward-looking statements due to various important factors, including, but notlimited to: our ability to become profitable; our ability to procure sufficient fundingto advance our programs; risks associated with raising additional capital andrequirements under our current debt instruments and effects of restrictions thereunder;our operating expenses and our ability to predict what those expenses will be; ourlimited operating history; the success of our programs and product candidates in which weexpend our resources; our limited ability or inability to assess the safety and efficacyof our product candidates; the risk that other genome-editing technologies may providesignificant advantages over our ARCUS technology; our dependence on our ARCUS technology;the initiation, cost, timing, progress, achievement of milestones and results of researchand development activities and preclinical and clinical studies; public perception aboutgenome editing technology and its applications; competition in the genome editing,biopharmaceutical, and biotechnology fields; our or our collaborators' ability toidentify, develop and commercialize product candidates; pending and potential productliability lawsuits and penalties against us or our collaborators related to ourtechnology and our product candidates; the U.S. and foreign regulatory landscapeapplicable to our and our collaborators' development of product candidates; our or ourcollaborators' ability to advance product candidates into, and successfully design,implement and complete, clinical or field trials; potential manufacturing problemsassociated with the development or commercialization of any of our product candidates;our ability to obtain an adequate supply of T cells from qualified donors; our ability toachieve our anticipated operating efficiencies at our manufacturing facility; delays ordifficulties in our and our collaborators' ability to enroll patients; changes in interim"top-line" and initial data that we announce or publish; if our product candidates do notwork as intended or cause undesirable side effects; risks associated with applicablehealthcare, data protection, privacy and security regulations and our compliancetherewith; our ability to obtain orphan drug designation or fast track designation forour product candidates or to realize the expected benefits of these designations; our orour collaborators' ability to obtain and maintain regulatory approval of our productcandidates, and any related restrictions, limitations and/or warnings in the label of anapproved product candidate; the rate and degree of (MORE TO FOLLOW) Dow Jones Newswires August 15, 2023 19:04 ET (23:04 GMT)Press Release: Precision BioSciences Completes -2-market acceptance of any of our product candidates; our ability to effectively manage thegrowth of our operations; our ability to attract, retain, and motivate executives andpersonnel; effects of system failures and security breaches; insurance expenses andexposure to uninsured liabilities; effects of tax rules; effects of any pandemic,epidemic, or outbreak of an infectious disease; the success of our existing collaborationagreements, and our ability to enter into new collaboration arrangements; our current andfuture relationships with and reliance on third parties including suppliers andmanufacturers; our ability to obtain and maintain intellectual property protection forour technology and any of our product candidates; potential litigation relating toinfringement or misappropriation of intellectual property rights; effects of natural andmanmade disasters, public health emergencies and other natural catastrophic events;effects of sustained inflation, supply chain disruptions and major central bank policyactions; market and economic conditions; risks related to ownership of our common stock,including fluctuations in our stock price, and other important factors discussed underthe caption "Risk Factors" in our Quarterly Report on Form 10-Q for the quarterly periodended June 30, 2023, as any such factors may be updated from time to time in our otherfilings with the Securities and Exchange Commission ("SEC"), which are accessible on theSEC's website at www.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 anyforward-looking statements contained herein, whether as a result of any new information,future events, changed circumstances or otherwise. View source version on businesswire.com:https://www.businesswire.com/news/home/20230815091930/en/ CONTACT: Investor and Media Contact: Mei Burris Director, Investor Relations and Finance [email protected] (END) Dow Jones Newswires August 15, 2023 19:04 ET (23:04 GMT)Wednesday 16 August 2023 09:04:00.000 AEST