Fusion Pharmaceuticals Announces Nomination of First Targeted Alpha Therapy Candidate in Collaboration with AstraZeneca to Advance into IND-Enabling Studies for Phase 1 Development

On January 10, 2022 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported nomination of the first targeted alpha therapy (TAT) candidate under the Company’s collaboration agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) (Press release, Fusion Pharmaceuticals, JAN 10, 2022, View Source [SID1234598589]). Both companies will jointly develop through a Phase 1 study the novel TAT which utilizes Fusion’s Fast-Clear linker technology to radiolabel an AstraZeneca-owned bispecific antibody with the alpha-emitting isotope, actinium-225.

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"Fusion is at the forefront developing a new wave of cancer therapies using alpha-emitting medical isotopes and various targeting vehicles," said John Valliant, Ph.D. "One of the pillars of our platform is to create next-generation immunoconjugates, and we are excited to be working with AstraZeneca to pursue a novel radioimmunoconjugate for oncology. We had strong alignment among our joint development committee to move this novel TAT forward into a planned Phase 1 study and we look forward to sharing more information as we approach the investigational new drug application (IND) filing."

Under the terms of the previously announced collaboration agreement, Fusion will be operationally responsible for preclinical development through first-in-human studies, while AstraZeneca will be responsible for subsequent clinical development. The companies will share costs equally through clinical development. IND enabling studies are ongoing.

Corporate Presentation

On January 10, 2022, Sutro Biopharma, Inc. (the "Company") Presented the corporate presentation (Presentation, Sutro Biopharma, JAN 10, 2022, View Source [SID1234598567]).

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ROYALTY PHARMA HIGHLIGHTS ACCOMPLISHMENTS AND PROVIDES BUSINESS UPDATE AT 40TH ANNUAL J.P. MORGAN HEALTHCARE CONFERENCE

On January 10, 2022 Royalty Pharma plc (Nasdaq: RPRX) reported an update on its business performance, including recent key accomplishments and the full-year 2021 outlook for Net cash provided by operating activities (a GAAP financial measure) and Adjusted Cash Receipts (a non- GAAP financial measure). Pablo Legorreta, Royalty Pharma’s founder and Chief Executive Officer, will discuss these updates today as part of a webcast presentation at the 40th Annual J.P. Morgan Healthcare Conference to be held virtually at 8:15 a.m. Eastern Time (Press release, Royalty Pharma , JAN 10, 2022, View Source [SID1234598566]).

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"I am very pleased with the performance of Royalty Pharma in 2021," said Pablo Legorreta. "We strengthened our longstanding leadership position, delivered impressive financial results and deployed substantial capital on new royalty transactions which will help drive future growth. Given the extraordinary pace of medical advances and our unique role at the heart of funding life science innovation, I am confident that we will deliver attractive, compounding growth in the coming years."

Strong 2021 Financial Performance

Based on preliminary unaudited fourth quarter 2021 results, Royalty Pharma expects Net cash provided by operating activities (GAAP) to be in the range of $2,010 to $2,030 million for full-year 2021. Additionally, Royalty Pharma now expects to deliver Adjusted Cash Receipts(1) (non-GAAP financial measure) for full-year 2021 at the high end of its guidance range of $2,110 to $2,130 million, which represents growth of 18% year-over-year. This strong double-digit growth in Adjusted Cash Receipts was achieved despite a significant decline in royalties from the HIV franchise, which was the company’s fourth largest royalty in 2020.

Royalty Pharma also enhanced its balance sheet in 2021 through an innovative $1.3 billion debt financing, which included its first-ever social bond.

Royalty Pharma’s preliminary unaudited fourth quarter 2021 results provided in this press release are subject to change in connection with the completion of the company’s final closing procedures, final adjustments and other developments that may arise in the course of the preparation or audit of its financial statements. Royalty Pharma’s management will host a conference call to discuss the company’s fourth quarter and full year 2021 results in the coming weeks.

Strong Capital Deployment Added Innovative Therapies, Enhancing Long-term Growth

Royalty Pharma has previously disclosed that it expects to deploy approximately $7 billion in capital on new royalty transactions over the period 2020 to 2025. Given the rapid pace of life science innovation – and the accompanying demands for capital from the biopharma industry – the company is tracking well ahead of its plan. From 2020 to 2021, Royalty Pharma has announced transactions of $5.5 billion, including $3.0 billion in 2021.

In total, through these transactions, 20 therapies have been added to Royalty Pharma’s portfolio (of which nine are either currently or projected to be blockbusters that generate annual sales of $1 billion or more based on consensus estimates). These new medicines are expected to make a significant contribution to the company’s financial performance in the coming years. In aggregate, based on consensus sales forecasts, these investments are estimated to add more than $750 million to Royalty Pharma’s annual Adjusted Cash Receipts in 2025 with potential upside from development-stage therapies.

Webcast of J.P. Morgan Healthcare Conference

Royalty Pharma will present at the 40th Annual J.P. Morgan Healthcare Conference at 8:15 a.m. ET today. The webcast will be accessible from Royalty Pharma’s "Events" page at View Source The webcast will also be archived for a minimum of thirty days.

Jazz Pharmaceuticals Announces Vision 2025 to Deliver Sustainable Growth and Enhanced Value to Drive Transformation to Innovative, Global Biopharmaceutical Leader

On January 10, 2022 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported its Vision 2025 to deliver sustainable growth and enhanced value. Vision 2025 includes the following expectations: 1) generating $5 billion in revenue in 2025; 2) approval of at least five additional novel products by the end of the decade; and 3) realizing a 5% adjusted operating margin1 improvement from 2021 to 2025, driven by operational excellence (Press release, Jazz Pharmaceuticals, JAN 10, 2022, View Source [SID1234598565]). The Company also confirmed that it expects to meet its previously announced 2021 revenue guidance range of $3.02 to $3.1 billion and its net product sales guidance for neuroscience and oncology.2

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Jazz ended 2021 demonstrating executional excellence across its business, including launching five key products in 2020 and 2021, integrating the GW Pharmaceuticals business, making progress towards its deleveraging target and initiating multiple potentially registrational clinical trials. The Company remains on track to deliver revenue diversification, with at least 65% of 2022 net product revenue from newly launched or acquired products,3 driving sustainable growth and enhanced shareholder value.

"Building on our track record of strong execution and guided by our patient-centric approach, Jazz is setting forth its Vision 2025 to deliver meaningful treatment options to patients, a great place to work for employees and significant value to shareholders," said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals. "Jazz’s leadership in sleep and rare epilepsy with Xywav and Epidiolex, respectively, coupled with promising new oncology products like Zepzelca and Rylaze, have led to the rapid transformation of our revenue base. We are further poised to enter new disease areas with serious unmet patient need and substantial market potential, including movement disorders and PTSD, with our mid-to late-stage assets nabiximols, suvecaltamide (JZP385) and JZP150. We expect our continued operational excellence to drive a five-percentage point improvement in our adjusted operating margin from 2021 to 2025, and we are confident in our ability to continue to leverage strategic capital allocation to grow our business."

Vision 2025 includes the following expectations:

Commercial: Generating $5 billion in revenue in 2025

Approximately $2.0 billion from oxybate franchise, which includes Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution in narcolepsy and idiopathic hypersomnia, Xyrem (sodium oxybate) oral solution and royalties from Xyrem authorized generics.

Approximately $2.5 billion from Epidiolex/Epidyolex (cannabidiol) and oncology franchise, including new products Zepzelca (lurbinectedin) and Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn).

Approximately $0.5 billion from additional growth opportunities, internal clinical development pipeline and future corporate development.

Pipeline: Approval of at least five additional novel products by the end of the decade

The Company’s pipeline has expanded four-fold since 2015 with 18 novel candidates currently in development. Jazz completed 11 licensing and M&A deals since 2019 alone, including five programs in clinical-stage development.

Jazz believes its pipeline is positioned to deliver at least five additional novel product approvals in areas of critical unmet patient need and significant market opportunity by the end of the decade.

Operational excellence: Driving a 5% adjusted operating margin1 improvement from 2021 to 2025

The Company is focused on disciplined investment to drive both top- and bottom-line growth and an improvement of five percentage points to its adjusted operating margin from 2021 to 2025, leveraging its global neuroscience and oncology businesses.

Strategic capital allocation will continue to be an important driver of the Company’s growth. Jazz is on track to achieve its net leverage ratio4 target of being below 3.5x by the end of 2022, which provides flexibility to continue smaller-scale corporate development as the Company delevers. In addition, Jazz will contemplate larger scale corporate development in the coming years to accelerate growth and diversification.

Presentation and Webcast

Bruce Cozadd will provide a corporate overview and discuss the Company’s Vision 2025 during the virtual presentation at the 40th Annual J.P. Morgan Healthcare Conference from 2:15 – 2:55 p.m. ET / 7:15 – 7:55 p.m. GMT on Monday, January 10, 2022.

A live audio webcast of the presentation may be accessed from the Investors section of the Jazz Pharmaceuticals website at www.jazzpharma.com. Please connect to the website prior to the start of the presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast. A replay of the webcast will be available on the website for 30 days.

BigHat Biosciences Completes First Stage of Research Collaboration with Amgen

On January 10, 2022 BigHat Biosciences, Inc., a biotechnology company with an artificial intelligence/machine learning-guided antibody discovery and development platform, reported the successful completion of the first stage of a previously undisclosed research collaboration and licensing agreement with Amgen applying BigHat’s platform for multi-objective optimization of a next-generation antibody (Press release, Amgen, JAN 10, 2022, View Source [SID1234598561]).

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BigHat’s antibody design platform integrates a high-speed characterization with AI/ML technologies to engineer antibodies with more complex functions and better biophysical properties. This approach reduces the difficulty of designing antibodies and other therapeutic proteins to tackle conditions ranging from chronic illness to life-threatening disease. BigHat’s experimental platform massively speeds up candidate discovery and validation.

"This is an important milestone for BigHat, and the AI/ML biologics drug discovery field more broadly, as it demonstrates the ability of their platform to quickly and significantly optimize next-generation antibodies," said Steve Doberstein, BigHat Independent Board Member and former Chief R&D Officer at Nektar Therapeutics, Inc.

Achievement of this first milestone shows that BigHat’s platform has the potential to design high-quality therapeutic antibodies effectively and efficiently. Its platform can synthesize, express, purify, and characterize antibodies in a fraction of the time compared to traditional labs to guide the search for better molecules.

"BigHat’s platform for data-driven antibody design generated several antibodies significantly better than the starter molecules found using traditional technologies," added Vineeta Agarwala, MD, PhD, General Partner at Andreessen Horowitz and BigHat Board Director. "Now that Amgen has validated the capabilities of BigHat’s unique approach to antibody development, we’re excited to continue working with them towards a lead antibody for their discovery research."

This successful milestone triggers the initiation of work to create a lead panel of VHH antibodies for patients in need. "We are excited to show the power of our platform to rapidly improve biophysical characteristics and function by directing and learning from each cycle of our AI/ML-enabled experimental platform. We are looking forward to continuing our productive collaboration," said Peyton Greenside, BigHat’s CSO and Co-Founder.