CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--KalVista Pharmaceuticals, Inc. (NASDAQ: KALV) (“KalVista”), today announced the closing of a synthetic royalty financing agreement with DRI Healthcare Trust (“DRI”) for up to $179 million, comprised of a $100 million upfront payment, a one-time $22 million optional payment upon U.S.

马萨诸塞州剑桥市和英国索尔兹伯里市——（商业新闻短讯）——KalVista Pharmaceuticals，Inc.（纳斯达克：KALV）（“KalVista”）今天宣布，与DRI Healthcare Trust（“DRI”）达成了一项合成特许权使用费融资协议，协议金额高达1.79亿美元，其中包括1亿美元的预付款，这是美国。

product approval, and up to $57 million in a sales-based milestone payment. The proceeds of this transaction will be used to fund the commercialization of sebetralstat, which, if approved, is expected to be the first approved oral on-demand therapy to treat hereditary angioedema (“HAE”). KalVista has a New Drug Application for sebetralstat under review by the U.S.

产品批准，以及高达5700万美元的基于销售的里程碑付款。这笔交易的收益将用于资助sebetralstat的商业化，如果获得批准，这将是第一个批准的治疗遗传性血管性水肿（“HAE”）的口服按需治疗。美国正在审查KalVista针对sebetralstat的新药申请。

Food and Drug Administration (the “FDA”) with a Prescription Drug User Free Act (“PDUFA”) target action date of June 17, 2025..

美国食品和药物管理局（FDA）制定了《处方药免费法案》（PDUFA），目标行动日期为2025年6月17日。

DRI has also indicated an interest in investing up to $5 million in KalVista’s common stock in a private placement transaction. However, this indication of interest is not binding agreement or commitment to purchase KalVista’s common stock and DRI may decide to purchase more, less or no shares of KalVista’s common stock and KalVista may decide to not sell shares of its common stock to DRI..

DRI还表示有兴趣在私募交易中投资高达500万美元的KalVista普通股。然而，该意向书不具有购买KalVista普通股的约束性协议或承诺，DRI可能会决定购买更多、更少或不购买KalVista普通股，而KalVista可能会决定不向DRI出售其普通股。

“This financing arrangement is a pivotal step for KalVista, enabling us to continue building a global commercial organization ahead of the potential U.S. launch of sebetralstat in June 2025,” said Ben Palleiko, Chief Executive Officer of KalVista. “Moving forward, we are well-positioned to achieve long-term sustainable growth as we focus on delivering a potentially transformative treatment for people living with HAE.

KalVista首席执行官本·帕莱科（BenPalleiko）表示：“这一融资安排是KalVista迈出的关键一步，使我们能够在2025年6月美国可能推出sebetralstat之前继续建立一个全球商业组织。”。“展望未来，随着我们专注于为HAE患者提供潜在的变革性治疗，我们处于实现长期可持续增长的良好地位。

We appreciate DRI’s confidence in KalVista and sebetralstat to make this their first pre-approval investment.”.

我们感谢DRI对KalVista和sebetralstat的信心，使其成为首次获得批准的投资。”

“Our royalty investment reflects DRI’s research-driven belief that sebetralstat has the potential to be the foundational treatment for all people living with HAE. We are excited to support the KalVista team’s continued transformation toward a commercial organization at this important stage,” said Navin Jacob, Chief Investment Officer of DRI..

DRI首席投资官纳文·雅各布（NavinJacob）表示：“我们的版税投资反映了DRI以研究为导向的信念，即塞贝特拉斯坦（sebetralstat）有潜力成为所有HAE患者的基础治疗方法。我们很高兴在这一重要阶段支持KalVista团队继续向商业组织转型。”

“Acquiring a synthetic royalty on such a high-quality asset like sebetralstat showcases DRI’s willingness to develop partnerships with companies like KalVista who are seeking to meaningfully improve patients’ lives,” said Ali Hedayat, Acting Chief Executive Officer of DRI.

DRI代理首席执行官阿里·赫达亚特（AliHedayat）表示：“以sebetralstat等优质资产获得合成版税，表明DRI愿意与KalVista等公司建立合作伙伴关系，这些公司正在寻求有意义地改善患者的生活。”

Synthetic Royalty Financing Terms

综合特许权使用费融资条款

Under the terms of the synthetic royalty financing agreement, KalVista will immediately receive $100 million and be obligated to pay DRI a tiered royalty of 5.00% of annual global net sales up to and including $500 million, 1.10% of annual global net sales above $500 million and up to and including $750 million, and 0.25% of annual global net sales above $750 million.

。

KalVista is entitled to a potential one-time sales-based milestone payment of $50 million if annual global net sales of sebetralstat meet or exceed $550 million in any calendar year before January 1, 2031..

如果在2031年1月1日之前的任何日历年中，塞贝特拉尔斯塔的年度全球净销售额达到或超过5.5亿美元，则KalVista有权获得潜在的一次性销售里程碑付款5000万美元。。

If sebetralstat is approved prior to October 1, 2025, KalVista will have the option to receive a one-time payment of $22 million. If KalVista chooses to receive this optional payment, the royalty rate on net sales up to and including $500 million will increase from 5.00% to 6.00%, and the sales-based milestone amount will increase from $50 million to $57 million..

。如果KalVista选择接受这一可选付款，净销售额不超过5亿美元的特许权使用费将从5.00%增加到6.00%，基于销售额的里程碑金额将从5000万美元增加到5700万美元。

Jefferies LLC acted as exclusive financial advisor to KalVista on the synthetic royalty financing.

Jefferies LLC担任KalVista合成特许权使用费融资的独家财务顾问。

About Sebetralstat

关于Sebetralstat

Discovered and developed entirely by the scientific team at KalVista, sebetralstat is a novel, investigational oral plasma kallikrein inhibitor for the on-demand treatment of HAE. Sebetralstat received Fast Track and Orphan Drug Designations from the FDA, as well as Orphan Drug Designation and an approved Pediatric Investigational Plan from the European Medicines Agency (“EMA”)..

sebetralstat完全由KalVista的科学团队发现和开发，是一种新型的研究性口服血浆激肽释放酶抑制剂，用于按需治疗HAE。

About Hereditary Angioedema

关于遗传性血管性水肿

HAE is a rare genetic disease resulting in deficiency or dysfunction in the C1 esterase inhibitor (“C1INH”) protein and subsequent uncontrolled activation of the kallikrein-kinin system. People living with HAE experience painful and debilitating attacks of tissue swelling in various locations of the body that can be life-threatening depending on the location affected.

HAE是一种罕见的遗传疾病，导致C1酯酶抑制剂（“C1INH”）蛋白缺乏或功能障碍，并随后导致激肽释放酶-激肽系统的不受控制的激活。患有HAE的人会在身体的不同部位经历痛苦和衰弱的组织肿胀发作，根据受影响的部位，这些组织肿胀可能危及生命。

About KalVista Pharmaceuticals, Inc.

关于KalVista Pharmaceuticals，Inc。

KalVista Pharmaceuticals, Inc. is a global pharmaceutical company whose mission is to develop and deliver life-changing oral medicines for people affected by rare diseases with significant unmet need. Sebetralstat, KalVista’s novel, investigational candidate for the oral, on-demand treatment of hereditary angioedema, is under regulatory review by the FDA with a PDUFA goal date of June 17, 2025.

KalVista Pharmaceuticals，Inc.是一家全球性制药公司，其使命是为受罕见疾病影响且需求严重未得到满足的人群开发和提供改变生命的口服药物。卡维斯塔（KalVista）的小说《按需口服治疗遗传性血管性水肿的研究候选人》Sebetralstat正在接受FDA的监管审查，PDUFA的目标日期为2025年6月17日。

In addition, KalVista has completed marketing authorization application (“MAA”) submissions for sebetralstat to the EMA as well as regulatory authorities in the United Kingdom, Switzerland, Australia, and Singapore, and KalVista anticipates filing a MAA in Japan in late 2024..

此外，KalVista已向EMA以及英国、瑞士、澳大利亚和新加坡的监管机构提交了sebetralstat的营销授权申请（“MAA”），KalVista预计将于2024年底在日本提交MAA。

For more information about KalVista, please visit www.kalvista.com or follow on social media at @KalVista and LinkedIn.

有关KalVista的更多信息，请访问www.KalVista.com或关注社交媒体@KalVista和LinkedIn。

About DRI Healthcare Trust

关于DRI Healthcare Trust

DRI is managed by DRI Capital Inc. (“DRI Healthcare”), a pioneer in global pharmaceutical royalty monetization. Since its initial public offering in 2021, the Trust has deployed more than US$1.0 billion, acquiring more than 25 royalties on 20-plus drugs, including Eylea, Orserdu, Omidria, Spinraza, Stelara, Vonjo, Zejula and Zytiga.

DRI由DRI Capital Inc.（“DRI Healthcare”）管理，DRI Healthcare是全球制药特许权使用费货币化的先驱。自2021年首次公开募股以来，该信托基金已投入10多亿美元，收购了20多种药物的25多种特许权使用费，其中包括Eylea、Orserdu、Omidria、Spinraza、Stelara、Vonjo、Zejula和Zytiga。

DRI’s units are listed and trade on the Toronto Stock Exchange in Canadian dollars under the symbol “DHT.UN” and in U.S. dollars under the symbol “DHT.U”. To learn more, visit drihealthcare.com or follow DRI on LinkedIn..

DRI的股票在多伦多证券交易所上市交易，以加元计价，代码为“DHT.UN”，以美元计价，代码为“DHT.U”。要了解更多信息，请访问drihealthcare.com或在LinkedIn上关注DRI。

Forward-Looking Statements

前瞻性声明

This press release contains 'forward-looking' statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: 'anticipate,' 'intend,' 'plan,' 'goal,' 'seek,' 'believe,' 'project,' 'estimate,' 'expect,' 'strategy,' 'future,' 'likely,' 'may,' 'should,' 'will' and similar references to future periods.

本新闻稿包含1995年《美国私人证券诉讼改革法案》安全港条款所指的“前瞻性”声明。前瞻性陈述可以用“预期”、“打算”、“计划”、“目标”、“寻求”、“相信”、“项目”、“估计”、“预期”、“战略”、“未来”、“可能”、“可能”、“应该”、“将会”等词来识别，以及类似的未来时期的引用。

These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what KalVista expects. Examples of forward-looking statements include, among others, the potential and timing of royalty payments, the potential timing of an equity investment in KalVista’s common stock, expectations regarding KalVista’s regulatory submissions, the anticipated royalty income and anticipated sales of products underlying such royalties, timing or outcomes of communications with the FDA, the success of any efforts to commercialize sebetralstat, and the ability of sebetralstat and other candidates in development to treat HAE or other diseases.

这些声明受到许多风险和不确定性的影响，可能导致实际结果与KalVista的预期存在重大差异。前瞻性陈述的例子包括，特许权使用费支付的潜力和时间安排，对KalVista普通股股权投资的潜在时间安排，对KalVista监管提交的预期，预期特许权使用费收入和此类特许权使用费产品的预期销售额，与FDA沟通的时间安排或结果，任何商业化sebetralstat的努力的成功，以及sebetralstat和其他正在开发的候选人治疗HAE或其他疾病的能力。

Further information on potential risk factors that could affect KalVista’s business and financial results are detailed in its filings with the Securities and Exchange Commission, including in its annual report on Form 10-K for the year ended April 30, 2024, its quarterly reports on Form 10-Q, and its other reports that KalVista may make from time to time with the Securities and Exchange Commission.

有关可能影响KalVista业务和财务业绩的潜在风险因素的更多信息，请参见其向证券交易委员会提交的文件，包括截至2024年4月30日的10-K表格年度报告、10-Q表格季度报告以及KalVista可能不时向证券交易委员会提交的其他报告。

KalVista undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise..

KalVista没有义务公开更新任何前瞻性声明，无论是书面的还是口头的，无论是由于新信息、未来发展还是其他原因。