DURHAM, N.C.--(BUSINESS WIRE)--Precision BioSciences, Inc. (Nasdaq: DTIL), an advanced gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for sophisticated gene edits, including gene elimination, insertion, and excision, today announced completion of a strategic transaction with TG Therapeutics, Inc.

北卡罗来纳州达勒姆（商业新闻短讯）--Precision BioSciences，Inc.（纳斯达克：DTIL），一家先进的基因编辑公司，利用其新型专有ARCUS®平台开发体内基因编辑疗法，用于复杂的基因编辑，包括基因消除，插入和切除，今天宣布完成与TG Therapeutics，Inc.的战略交易。

(Nasdaq: TGTX) for an exclusive license to develop Azercabtagene Zapreleucel (azer-cel) for autoimmune diseases, and other indications outside of cancer..

（纳斯达克：TGTX）获得独家许可证，开发用于自身免疫性疾病和癌症以外的其他适应症的azercabatagene Zapreleucel（azer-cel）。。

“We are excited to extend the utility of our allogeneic CAR T assets into immunology by collaborating with TG Therapeutics as they advance novel treatments for B-cell diseases. Key factors in our decision to partner with the TG team include their recent development, regulatory and commercial successes in the multiple sclerosis space, which we believe are strong indicators of the commitment and expertise they will bring to the development of azer-cel in autoimmune diseases,” said Michael Amoroso, President and Chief Executive Officer at Precision BioSciences.

“我们很高兴通过与TG Therapeutics合作，将我们的同种异体CAR T资产的效用扩展到免疫学领域，因为他们正在推进B细胞疾病的新疗法。我们决定与TG团队合作的关键因素包括他们在多发性硬化症领域的最新发展，监管和商业成功，我们认为这是承诺和Precision BioSciences总裁兼首席执行官迈克尔·阿莫罗索（MichaelAmoroso）表示：“他们将为azer-cel在自身免疫性疾病方面的发展带来专业知识。”。

“As TG Therapeutics assumes development of azer-cel for immunology, Precision will remain focused on capitalizing on the utility of ARCUS for gene elimination and gene insertion, beginning with our wholly owned PBGENE-HBV program for chronic hepatitis B and PBGENE-PMM for primary mitochondrial myopathy.”.

“随着TG Therapeutics假定azer cel用于免疫学的发展，Precision将继续专注于利用ARCUS用于基因消除和基因插入，从我们全资拥有的用于慢性乙型肝炎的PBGENE-HBV计划和用于原发性线粒体肌病的PBGENE-PMM开始。”。

“After an extensive review of the CAR T products available for development in immunology, we are excited to bring azer-cel into our portfolio as we look to expand our offerings for patients suffering from autoimmune diseases,” said Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics.

TG Therapeutics董事长兼首席执行官迈克尔·韦斯（Michael S.Weiss）表示：“在对可用于免疫学开发的CAR T产品进行了广泛审查后，我们很高兴将azer cel纳入我们的产品组合，因为我们希望扩大为患有自身免疫性疾病的患者提供的产品。”。

“We are pleased to partner with Precision BioSciences for azer-cel, and the equity investment we are making is indicative of our optimism in the near- and long-term opportunities for ARCUS for in vivo gene editing.”.

“我们很高兴与Precision BioSciences为azer cel合作，我们正在进行的股权投资表明我们对ARCUS进行体内基因编辑的近期和长期机会感到乐观。”。

In exchange for global rights to azer-cel for autoimmune diseases and indications outside of cancer, Precision will receive upfront and potential near-term economics valued at $17.5 million. The upfront payment of $7.5 million will consist of cash and the purchase of 2,920,816 shares of Precision common stock by TG Therapeutics at a price of $0.77 per share, a 100% premium to the 30-day volume-weighted average price (VWAP) prior to purchase.

作为对azer cel自身免疫性疾病和癌症以外适应症的全球权利的交换，Precision将获得价值1750万美元的前期和潜在的近期经济效益。750万美元的预付款将包括现金和TG Therapeutics以每股0.77美元的价格购买2920816股Precision普通股，比购买前30天的成交量加权平均价格（VWAP）溢价100%。

Precision will also receive $2.5 million within 12 months, as an equity investment in Precision’s common stock at 100% premium to the then 30-day VWAP prior to purchase. Upon the achievement of certain near-term clinical milestones, Precision will receive an additional $7.5 million payment in cash and the purchase of Precision common stock by TG Therapeutics at a 100% premium to the then current 30-day VWAP.

Precision还将在12个月内获得250万美元，作为对Precision普通股的股权投资，比收购前30天的VWAP溢价100%。在实现某些近期临床里程碑后，Precision将获得750万美元的额外现金支付，以及TG Therapeutics以当时30天VWAP的100%溢价购买Precision普通股。

Precision is eligible to receive up to $288 million in additional milestone payments based on the achievement of certain clinical, regulatory, and commercial milestones, in addition to high-single-digit to low-double-digit royalties on net sales..

Precision有资格获得高达2.88亿美元的额外里程碑付款，这是基于某些临床，监管和商业里程碑的实现，以及净销售额的高个位数到低个位数的版税。。

“With this deal and the Imugene oncology collaboration for azer-cel announced in August 2023, Precision has now completed two cell therapy collaborations to realize value from our allogeneic CAR T platform while enabling development of azer-cel for patients in diseases with high unmet need. These transactions are expected to extend our runway and will fund continued development of our wholly owned in vivo gene editing programs.

“通过这笔交易以及2023年8月宣布的azer cel的Imugene肿瘤学合作，Precision现已完成了两项细胞治疗合作，以实现我们同种异体CAR T平台的价值，同时为未满足需求的疾病患者开发azer cel。这些交易有望延长我们的跑道，并将为我们的整体发展提供资金ned体内基因编辑程序。

As a result of these two accretive partnerships, Precision has received or is eligible to receive $47 million in upfront and potential near-term payments and has the potential to receive more than $900 million in development, regulatory and commercial milestone payments,” added Mr. Amoroso..

由于这两个增值合作关系，Precision已收到或有资格收到4700万美元的预付款和潜在的短期付款，并有可能收到超过9亿美元的开发、监管和商业里程碑付款，”阿莫罗佐先生补充道。。

Although it has not finalized its full financial results for the year ended December 31, 2023, Precision expects to report that it had approximately $116 million in cash and cash equivalents as of December 31, 2023. Upfront and potential near-term cash from azer-cel transactions, along with existing cash and cash equivalents, expected operational receipts, continued fiscal and operating discipline, availability of Precision’s at-the-market (ATM) facility, and available credit are expected to extend Precision’s cash runway into the first half of 2026 and through clinical phase 1 readouts for its wholly owned HBV and PMM programs..

尽管Precision尚未最终确定截至2023年12月31日止之年度的全部财务业绩，但预计截至2023年12月31日，其拥有约1.16亿美元的现金和现金等价物。azer cel交易产生的前期和潜在短期现金，以及现有现金和现金等价物、预期运营收入、持续的财务和运营纪律、市场精准（ATM）设施的可用性，预计可用信贷将使Precision的现金跑道延长至2026年上半年，并通过其全资拥有的HBV和PMM项目的临床第一阶段读数。。

Precision will continue to evaluate potential partners for other assets from its allogeneic CAR T platform that are no longer being developed internally, including PBCAR19B stealth cell and BCMA targeting CAR T assets for multiple myeloma.

Precision将继续评估其同种异体CAR T平台中不再在内部开发的其他资产的潜在合作伙伴，包括PBCAR19B隐形细胞和针对多发性骨髓瘤的BCMA靶向CAR T资产。

About Precision BioSciences, Inc.

关于Precision BioSciences，Inc。

Precision BioSciences, Inc. is an advanced gene editing company dedicated to improving life (DTIL) with its novel and proprietary ARCUS® genome editing platform that differs from other technologies in the way it cuts, its smaller size, and its simpler structure. Key capabilities and differentiating characteristics may enable ARCUS nucleases to drive more intended, defined therapeutic outcomes.

Precision BioSciences，Inc.是一家致力于改善生命（DTIL）的先进基因编辑公司，其新颖专有的ARCUS®基因组编辑平台在切割方式，尺寸较小和结构更简单方面与其他技术不同。关键能力和差异化特征可能使ARCUS核酸酶能够驱动更预期的，明确的治疗结果。

Using ARCUS, the Company’s pipeline is comprised of in vivo gene editing candidates designed to deliver lasting cures for the broadest range of genetic and infectious diseases where no adequate treatments exist. For more information about Precision BioSciences, please visit www.precisionbiosciences.com..

使用ARCUS，该公司的管道由体内基因编辑候选人组成，旨在为没有足够治疗方法的最广泛的遗传和传染病提供持久的治疗。有关精密生物科学的更多信息，请访问www.precisionbiosciences.com。。

Forward-Looking Statements

前瞻性声明

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 product candidates (including azer-cel) and gene editing approaches including editing efficiency and differentiating aspects; the suitability of azer-cel for oncology indications and non-oncology indications including immunological diseases; the suitability of ARCUS nucleases for gene insertion, large gene deletion, and other gene editing approaches; the expected timing of regulatory processes; expectations about our operational initiatives and business strategy; expectations around partnership opportunities; our expected cash runway; 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 initial clinical data.

本新闻稿包含1995年《私人证券诉讼改革法案》所指的前瞻性声明。本新闻稿中包含的所有与历史事实无关的声明均应视为前瞻性声明，包括但不限于关于我们候选产品（包括azer cel）的临床开发和预期安全性，有效性和益处的声明以及基因编辑方法，包括编辑效率和差异化方面；azer cel对肿瘤适应症和非肿瘤适应症（包括免疫性疾病）的适用性；ARCUS核酸酶对基因插入，大基因缺失和其他基因编辑方法的适用性；监管过程的预期时间；对我们的运营计划和业务战略的期望；对合作机会的期望；我们预期的现金跑道；对实现关键里程碑和收到任何里程碑、版税或其他付款的期望；对我们流动性和资本资源的期望；以及初始临床数据的预期时间。

In some cases, you can identify forward-looking statements by terms such as “aim,” “anticipate,” “approach,” “believe,” “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..

在某些情况下，您可以通过“目标”、“预期”、“方法”、“相信”、“沉思”、“可能”、“估计”、“预期”、“目标”、“打算”、“看起来”、“可能”、“任务”、“计划”、“可能”、“潜力”、“预测”、“项目”、“追求”、“应该”、“目标”、“将会”、“将会”或否定词及类似词语。。

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 liabi.

前瞻性陈述基于管理层当前的期望、信念和假设以及我们目前可获得的信息。这些陈述既不是承诺也不是保证，涉及许多已知和未知的风险、不确定性和假设，由于各种重要因素，包括但不限于我们的盈利能力，实际结果可能与前瞻性陈述中明示或暗示的结果存在重大差异；我们有能力获得足够的资金来推进我们的计划；与我们的资本要求、预期现金周转、我们当前债务工具的要求和限制的影响相关的风险，包括我们由于市场条件和/或我们的市值而筹集额外资本的能力；我们的运营费用和预测这些费用的能力；我们有限的经营历史；我们花费资源的计划和候选产品的进展和成功；我们的能力有限或无法评估候选产品的安全性和有效性；其他基因组编辑技术可能比我们的ARCUS技术具有显着优势的风险；我们对ARCUS技术的依赖；研究和开发活动以及临床前和临床研究（包括临床试验和研究性新药应用）的启动，成本，时间，进度，里程碑的实现和结果；公众对基因组编辑技术及其应用的看法；基因组编辑，生物制药和生物技术领域的竞争；我们或我们的合作者或其他被许可方识别、开发和商业化候选产品的能力；未决和潜在产品责任。

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..

所有前瞻性声明仅在本新闻稿发布之日有效，除适用法律要求外，我们没有义务更新或修订本新闻稿中包含的任何前瞻性声明，无论是由于任何新信息、未来事件、情况变化或其他原因。。