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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]).

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.

Evotec expands neuroscience collaboration with Bristol Myers Squibb to include new targeted protein degradation approach

On January 10, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported that the Company has expanded its neurodegeneration collaboration with Bristol Myers Squibb (NYSE:BMY) with the initiation of discovery and development efforts regarding a new strategy to tackle neurodegenerative diseases including Alzheimer’s through a novel approach to targeted protein degradation (Press release, Evotec, JAN 10, 2022, View Source [SID1234598560]). Evotec receives payments totalling US$ 15 m from Bristol Myers Squibb.

Under the expansion, Bristol Myers Squibb increases its access to a novel targeted protein degradation approach. The focus will be on selected targets that are relevant to a range of neurodegenerative conditions.

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: "Our collaboration with Bristol Myers Squibb in the field of neurodegenerative disease continues to be highly productive. Many neurodegenerative diseases are driven by disease-causing proteins which have proven to be elusive to traditional drug discovery approaches. We are committed to continuously explore novel drug targeting mechanisms and modalities and are delighted to have a strong partner with BMS in this endeavour."

The neurodegeneration collaboration between Evotec and Bristol Myers Squibb was initiated in December 2016 with the goal of identifying disease-modifying treatments for a broad range of neurodegenerative diseases. Currently approved drugs only offer short-term management of the patients’ symptoms despite a huge unmet medical need for drugs that have the potential to slow down or reverse disease progression. The collaboration leverages Evotec’s industrialised iPSC platform using patient-derived disease models, which is one of the largest and most sophisticated platforms in the industry.

Celsion Corporation Announces Pricing of $30 Million Registered Direct Offerings of Convertible Redeemable Preferred Stock

On January 10, 2022 Celsion Corporation (NASDAQ: CLSN), a clinical-stage development company focused on DNA-based immunotherapy and next-generation vaccines, reported that it has entered into a securities purchase agreement with certain institutional investors to purchase 50,000 shares of Series A convertible redeemable preferred stock and 50,000 shares of Series B convertible redeemable preferred stock (Press release, Celsion, JAN 10, 2022, View Source [SID1234598559]). Each share of Series A and Series B preferred stock has a purchase price of $285, representing an original issue discount of 5% of the $300 stated value of each share. Each share of Series A preferred stock is convertible into shares of Celsion’s common stock at an initial conversion price of $0.91 per share. Each share of Series B preferred stock is convertible into shares of Celsion’s common stock at an initial conversion price of $1.00 per share. Shares of the Series A and Series B preferred stock are convertible at the option of the holder at any time following the Company’s receipt of stockholder approval for a reverse stock split of the Company’s common stock. Celsion will be permitted to compel conversion of the Series A and Series B preferred stock after the fulfillment of certain conditions and subject to certain limitations. Total net proceeds from the offerings, before deducting the placement agent’s fees and other estimated offering expenses, is approximately $28.5 million.

The Series A and Series B preferred stock permit the holders thereof to vote together with the holders of the Company’s common stock on a proposal to effectuate a reverse stock split of the Company’s common stock at a special meeting of Company stockholders. The Series A preferred stock permits the holder to vote on such proposal on an as-converted to common stock basis. The Series B preferred stock permits the holder to cast 45,000 votes per share of Series B preferred stock on such proposal. The Series A and Series B preferred stock will not be permitted to vote on any other matter. The holders of the Series A and B preferred stock agreed not to transfer their shares of preferred stock until after the special meeting of Company stockholders. The holders of the Series A preferred stock agreed to vote their shares in favor of that proposal and the holders of the Series B preferred stock agreed to vote their shares in the same proportions as the shares of common stock and Series A preferred stock are voted on that proposal. The holders of the Series A and Series B preferred stock have the right to require the Company to redeem their shares of preferred stock for cash at 105% of the stated value of such shares commencing after the earlier of the Company’s stockholders’ approval of the reverse stock split and 90 days after the closing of the issuances of the Series A and Series B preferred stock and until 120 days after such closing.

The closing of the offerings is expected to occur on or about January 13, 2022, subject to the satisfaction of customary closing conditions. Additional information regarding the securities described above and the terms of the offering are included in a Current Report on Form 8-K to be filed with the United States Securities and Exchange Commission ("SEC").

A.G.P. /Alliance Global Partners is acting as the sole placement agent in connection with the offering.

The Series A and Series B preferred stock and shares of common stock into which such preferred stock are convertible are being offered pursuant to a registration statement on Form S-3 (333-254515), which was declared effective by the Securities and Exchange Commission on March 30, 2021. The offerings will be made only by means of prospectus supplements and a prospectus that form a part of the registration statement. Copies of the final prospectus supplements and accompanying prospectus relating to the registered direct offering may be obtained from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022 at (212) 624-2060.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

C4 Therapeutics Announces 2022 Key Milestones to Advance Targeted Protein Degradation Portfolio

On January 10, 2022 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science to develop a new generation of small-molecule medicines and transform how disease is treated, reported strategic priorities and 2022 milestones to advance its targeted protein degradation portfolio (Press release, C4 Therapeutics, JAN 10, 2022, View Source [SID1234598558]).

"We are extremely proud of our achievements over the past year as we have advanced a new generation of orally bioavailable medicines that have the potential to transform how diseases are treated, notably bringing our lead program CFT7455 into the clinic," said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. "In the year ahead, we look forward to sharing initial clinical data on CFT7455, which we are investigating for the treatment of relapsed or refractory multiple myeloma and non-Hodgkin’s lymphomas, while also advancing additional oncology programs into the clinic. In parallel, we will demonstrate the productivity of our TORPEDO platform and leverage our strong cash position to further invest in discovery research and expand our capabilities to deliver the next wave of degrader medicines to patients."

STRATEGIC PRIORITIES AND ANTICIPATED 2022 MILESTONES

Advance multiple small molecule oncology degrader programs in the clinic to deliver a new generation of medicines that transforms patients’ lives

CFT7455: CFT7455 is a novel degrader targeting IKZF1/3 for the treatment of multiple myeloma (MM) and non-Hodgkin’s lymphomas (NHL), including peripheral T cell lymphoma and mantle cell lymphoma.

Present initial clinical data from Cohort A of the ongoing Phase 1/2 trial in relapsed or refractory MM and NHL at a medical meeting in 1H 2022.
Progress the CFT7455 Phase 1/2 trial toward identifying a recommended Phase 2 dose for MM and NHL.
CFT8634: CFT8634 is a degrader targeting BRD9 for the treatment of synovial sarcoma and SMARCB1-null solid tumors.

Initiate a Phase 1 trial in synovial sarcoma and SMARCB1-null solid tumors in 1H 2022.
CFT1946: CFT1946 is a mutant-selective degrader of BRAF V600X for the treatment of V600 mutant solid tumors.

Submit an investigational new drug (IND) application and begin a Phase 1 trial in BRAF V600X driven cancers including melanoma, colorectal and non-small cell lung (NSCLC) in 2H 2022.
CFT8919: CFT8919 is a potent and selective degrader of EGFR L858R for the treatment of NSCLC.

Complete IND-enabling activities by year-end 2022.
Demonstrate the productivity of TORPEDO platform to advance targeted protein degradation science

At a medical meeting in 1H 2022, C4T plans to present new pre-clinical data across multiple oncology programs:

CFT7455: Pre-clinical data characterizing the chemical structure of CFT7455 and the resulting improvements in potency and optimized pharmacokinetic properties.
CFT8634: Pre-clinical data on the discovery and characterization of CFT8634, a potent and selective degrader of BRD9 for the treatment of SMARCB1-perturbed cancers.
CFT1946: Pre-clinical data on the discovery and evaluation of CFT1946 as a selective degrader of mutant BRAF for the treatment of BRAF V600X driven cancers.
Continue to invest in C4T’s research engine to create the next wave of degrader medicines for difficult-to-drug oncology targets

Utilizing its proprietary TORPEDO platform, C4T will develop the next wave of targets that have the potential to transform patient care. In 2022, C4T will focus on leveraging its established MonoDAC library and BiDAC capabilities to pursue targets that are difficult to drug and not adequately addressed by other existing modalities.

RECENT HIGHLIGHTS

In addition, the Company also provided an update on recent progress:

Strengthened Leadership Team with Appointment of Chief Business Officer: Scott Boyle, Ph.D., MBA, has joined the Company as chief business officer. Dr. Boyle was previously vice president of business and corporate development at Forma Therapeutics, where he led business and corporate development initiatives, including portfolio prioritization strategy, program leadership for olutasidenib, and support for the company’s initial public offering. He joins C4T with over a decade of strategic planning and deal execution experience in the life science industry.
Received FDA Clearance of IND Application for CFT8634: In December 2021, the U.S. Food and Drug Administration (FDA) cleared the IND application for CFT8634. The FDA has completed its 30-day safety review and granted approval for C4T to proceed with the proposed Phase 1/2 clinical trial for CFT8634.
Presented at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition: Jesus G. Berdeja, M.D., director, multiple myeloma research at Sarah Cannon Research Institute, presented a trial-in-progress poster for the Phase 1/2 trial of CFT7455.
Added to the Nasdaq Biotechnology Index (NBI) and ICE Biotechnology Index (ICEBIO): Inclusion in these indices reflects C4T meeting eligibility criteria, including market capitalization standards and minimum average daily trading volume, as well as being engaged in research and development of therapeutic treatments.
CASH GUIDANCE
Unaudited cash, cash equivalents, and marketable securities as of December 31, 2021 were approximately $450 million. C4T expects its cash, cash equivalents, and marketable securities, including payments anticipated to be received under existing collaboration agreements, will be sufficient to fund its operating plan to the end of 2024.

UPCOMING INVESTOR EVENTS

January 10-13 – C4T will participate in the 40th Annual J.P. Morgan Healthcare Conference
February 16-18 – C4T will participate in the SVB Leerink Healthcare Conference
March 7-9 – C4T will participate in the Cowen & Co Healthcare Conference