Rtw Biotech Regulatory News (RTW)

LEI: 549300Q7EXQQH6KF7Z84

12 August 2020

RTW Venture Fund Limited

Portfolio Company Update

Strategic Collaboration, Series A Financing and Entry into China

RTW Venture Fund Limited (the "Company"), a London Stock Exchange listed investment company focused on identifying transformative assets with high growth potential across the life sciences sector, is pleased to announce two positive updates in connection with its portfolio company Ji Xing Pharmaceuticals ("Ji Xing").

Firstly, the Company notes the joint announcement by Ji Xing, an affiliate of RTW Investments, LP (the "Investment Manager" of the Company), and Cytokinetics, Incorporated (Nasdaq: "CYTK", "Cytokinetics"), a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors, on 14 July 2020 for an exclusive licensing agreement and collaboration for the development and commercialization of CK-274, a next-generation cardiac myosin inhibitor, in Greater China.

Secondly, the Company, alongside other funds managed by the Investment Manager, confirms that following its seed investment in Ji Xing earlier this year, it has participated in Ji Xing's Series A financing round with an investment of $5 million on 28 July 2020.

Ji Xing is a privately owned, leading Shanghai-based biotechnology company committed to bringing innovative science and medicines to underserved Chinese patients with serious and life-threatening diseases where there is estimated to be a significant unmet need. CK-274 is a novel cardiac myosin inhibitor in clinical development for hypertrophic cardiomyopathies (HCM), the most common inherited cardiovascular disorder with no current medical treatments that directly address the hypercontractility that underlies the condition.

Stephanie Sirota, Chief Business Officer of RTW, the Investment Manager, said:

"We believe it's important to foster scientific development by providing tailormade capital solutions to companies developing exceptional and innovative therapies. Investing globally is a strategic priority for the Company and we are pleased to take part in bringing promising innovative science to Chinese patients. We are excited for Ji Xing's partnership with Cytokinetics for CK-274, and look forward to supporting the collaboration."

The Company's further investment in Ji Xing marks its ninth investment across eight companies since its admission in October 2019.

This announcement and the aforementioned joint announcement dated 14 July 2020 can both be accessed on RTW's website www.rtwfunds.com and the full text of the joint announcement is contained below.

For Further Information

RTW Investments, LP +1 (646) 343 9280Stephanie Sirota, Chief Business OfficerAlexandra Taracanova, PhD, Director of Investor Relations

Julia Enright, Business Development Associate

Buchanan +44 (0)20 7466 5000Charles Ryland

Henry Wilson

About RTW Venture Fund Limited:

RTW Venture Fund Limited (LSE: RTW) is an investment fund focused on identifying transformative assets with high growth potential across the biopharmaceutical and medical technology sectors. Driven by a long-term approach to support innovative businesses, RTW Venture Fund invests in companies developing next-generation therapies and technologies that can significantly improve patients' lives.

RTW Venture Fund Limited is managed by RTW Investments, LP, a leading US healthcare investment firm with deep scientific expertise and a strong track record of supporting companies developing life-changing therapies.

Visit the RTW website at www.rtwfunds.com for more information.

Published July 14, 2020

RTW INVESTMENTS, LP, JI XING PHARMACEUTICALS AND CYTOKINETICS ENTER INTO STRATEGIC FINANCING COLLABORATION TO SUPPORT THE DEVELOPMENT OF CK-274 AND ENTER CHINA

$250 Million in Committed Capital to Cytokinetics

Additional $200 Million in Development and Commercialization Milestone Payments

RTW Investments, a global, full life-cycle investor provides a multi-faceted capital solution to support Cytokinetics' development of CK-274; including direct equity investment, royalty monetization, and royalty-backed development funding

Ji Xing announces licensing agreement to develop and commercialize CK-274 in Greater China

RTW Investments, LP, ("RTW") is pleased to announce Ji Xing Pharmaceuticals ("Ji Xing"), a biotechnology company based in Shanghai and backed by RTW, and Cytokinetics, a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors, have entered into an exclusive licensing agreement for the development and commercialization of CK-274, a next-generation cardiac myosin inhibitor, in Greater China. Ji Xing has committed to making an upfront payment plus $200 million in development and commercial milestones. As part of the agreement, Ji Xing will pay to Cytokinetics royalties on the net sales of the product in the region.

Ji Xing Chief Medical Officer, Jianyong Li, added: "As a cardiologist, I have seen first-hand the unmet need of Chinese HCM patients, and am excited by the potential of an innovative drug like CK-274."

Affiliates of RTW have simultaneously entered into a broad strategic funding agreement and equity purchase agreement with Cytokinetics. In addition to a direct equity investment in Cytokinetics of $50 million at $25.00 per share of common stock, RTW has committed to providing development funding of up to $90M for CK-274, for one or both indications of obstructive and non-obstructive hypertrophic cardiomyopathy, subject to commencement of each pivotal trial by specified dates. In exchange for providing this development funding, RTW will receive a royalty in the low single digits on net sales of CK-274 in the United States, European Union, United Kingdom, Switzerland and certain other European countries. In addition, RTW has agreed to purchase from Cytokinetics its royalty rights on future sales of mavacamten, for a cash purchase price of $85 million, subject to certain closing conditions.

Roderick Wong, MD, Managing Partner and Chief Investment Officer of RTW Investments, said: "We believe molecularly targeted therapies hold great promise to treat cardiovascular disease, and are excited to have the opportunity to partner with Cytokinetics to support CK-274. RTW is also proud to be unique in its ability to provide a mix of equity, non-dilutive capital, and geographic partnership to assist Cytokinetics in reaching its strategic goals." 

Cytokinetics President and CEO, Robert I. Blum, said: "We are pleased to enter into these transactions with RTW and Ji Xing to both accelerate and expand the development of CK-274 in cardiovascular diseases associated with hypercontractility," said Robert I. Blum, Cytokinetics' President and Chief Executive Officer. "Our organizations share a common conviction for the promise of this potential next-in-class therapy."

The broad-based transaction underscores the complexity of funding innovative scientific assets and the value add that comes from a partner, such as RTW, who both understands the scientific challenges of developing innovative new medicines and has the ability to enter into creative financial solutions on a global scale.

Peter Fong, CEO of Ji Xing and Head of Company Creation at RTW, said: "CK-274 has a promising clinical profile and fits perfectly into Ji Xing's strategic focus to bring innovative medicines to patients in China with underserved diseases. We look forward to a long partnership with Cytokinetics."

About CK-274

CK-274 is a novel, oral, small molecule cardiac myosin inhibitor that company scientists discovered independent of its collaborations. CK-274 arose from an extensive chemical optimization program conducted with careful attention to therapeutic index and pharmacokinetic properties that may translate into next-in-class potential in clinical development. CK-274 was designed to reduce the hypercontractility that is associated with hypertrophic cardiomyopathy (HCM). In preclinical models, CK-274 reduces myocardial contractility by binding directly to cardiac myosin at a distinct and selective allosteric binding site, thereby preventing myosin from entering a force producing state. CK-274 reduces the number of active actin-myosin cross bridges during each cardiac cycle and consequently reduces myocardial contractility. This mechanism of action may be therapeutically effective in conditions characterized by excessive hypercontractility, such as HCM.

In preclinical models of cardiac function, both in normal models of cardiac function and mouse models of HCM, CK-274 reduced cardiac contractility in a predictable dose and exposure dependent fashion. The preclinical pharmacokinetics of CK-274 were characterized, evaluated and optimized for potential ease of dose titration in the clinical setting. A Phase 1 study demonstrated that CK-274 was safe and well tolerated in healthy participants. The pharmacokinetics of CK-274 were generally dose linear, and steady-state appeared evident within 14 days of dosing. Left ventricular ejection fraction decreased in an exposure dependent manner and the pharmacokinetic/pharmacodynamic relationship for CK-274 observed in humans was similar to that observed preclinically when adjusted for differences in protein binding. Specifically, the shallow exposure-response relationship observed preclinically appears to translate to humans and may enable flexible dose optimization in humans.

The overall development program will assess the potential of CK‑274 to improve exercise capacity and relieve symptoms in patients with hyperdynamic ventricular contraction due to HCM.

For Further Information

RTW Investments, LP +1 (646) 343 9280Stephanie Sirota, Chief Business Officer

Ji Xing Pharmaceuticals +86 (021) 8031-1802

Ying Wang, VP Strategy and Corporate Development

About RTW Investments, LP:

RTW Investments, LP ("RTW") is a New York-based, global, full life-cycle investment firm that focuses on identifying transformational and disruptive innovations in biopharmaceutical and medical technologies. As a leading partner of industry and academia, RTW combines deep scientific expertise with a solution-oriented investment approach to support emerging medical therapies and the companies and/or academics developing them. For further information about RTW, please visit www.rtwfunds.com.

About Ji Xing Pharmaceuticals:

Backed by RTW Investments, Ji Xing is a privately held, leading Shanghai-based biotechnology company committed to bringing innovative science and medicines to underserved Chinese patients with serious and life-threatening diseases.