Celularity Enters Strategic Collaboration Agreement with Clinical Stage Cell Therapy Company

On February 24, 2025 Celularity Inc. (Nasdaq: CELU) ("Celularity" or the "Company"), a cellular and regenerative medicine company, reported that it has entered into a Master Services Collaboration Agreement with BlueSphere Bio, Inc. (BSB) covering manufacturing activities for certain BSB cell therapy products (Press release, Celularity, FEB 24, 2025, View Source [SID1234650467]). This collaboration is the second of its kind for Celularity and demonstrates the Company’s ability to leverage its world class cGMP manufacturing infrastructure and deep expertise to attract clients like BSB, who are seeking differentiated alternatives to manufacture their therapeutic products in an ever-changing landscape. This collaboration further evidences the revenue generating potential of Celularity’s assets.

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The Collaboration Agreement will initially focus on the production of BSB’s novel T cell receptor (TCR) T cell therapies using the technical and manufacturing capabilities at Celularity’s Florham Park, NJ, cGMP-ready facility. This collaboration will extend to all aspects of cell therapy manufacturing including Chemistry, Manufacturing and Controls (CMC), Quality Assurance and Quality Control. As part of this Collaboration, Celularity will dedicate staff and a small portion of its 37,000 square foot commercial manufacturing footprint. In coordination with Celularity management, BSB and its team will have oversight over production of its second cell therapy product for the treatment of Acute Myelogenous Leukemia (AML) both in the U.S. and abroad.

Robert J. Hariri, M.D., Ph.D., Celularity CEO and Chair, said, "We are delighted to announce this important collaboration, which will bring together our core strengths in cell manufacturing, process development and BSB’s development of novel cell therapies to treat high risk leukemias. Celularity has invested significant capital in its manufacturing and development infrastructure, with a vision to not only support its own programs, but to create a collaborative business model for companies like BSB, to leverage Celularity’s technical capabilities. This new relationship with BSB further realizes that objective and helps set the stage for future clients seeking transformative alternatives for any GMP manufacturing needs."

Keir Loiacono, CEO of BlueSphere noted, "Reliable and flexible manufacturing are critical to a successful cell therapy program. The quality of Celularity’s business model and facility will provide BlueSphere with the necessary tools to advance our assets to the clinic in an affordable fashion, without relinquishing control over our processes. The team at Celularity has been welcoming and open to addressing all our needs, and we look forward to working with them."

argenx to Present at TD Cowen 45th Annual Healthcare Conference

On February 24, 2025 argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, reported that Tim Van Hauwermeiren, Chief Executive Officer, will present at the TD Cowen 45th Annual Healthcare Conference on Monday, March 3, 2025 at 11:50 a.m. ET (Press release, argenx, FEB 24, 2025, View Source [SID1234650484]).

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A live webcast of the presentation may be accessed on the Investors section of the argenx website at argenx.com/investors. A replay of the webcast will be available on the argenx website for approximately 30 days following the presentation.

Coherus Management to Participate at the 45th Annual TD Cowen Health Care Conference

On February 24, 2025 Coherus BioSciences, Inc. ("Coherus," NASDAQ: CHRS) reported that senior management will participate in a fireside chat presentation at the 45th Annual TD Cowen Health Care Conference on Tuesday, March 4, 2025, at 11:50 a.m., Eastern time (Press release, Coherus Biosciences, FEB 24, 2025, View Source [SID1234650468]). A live audio webcast will be accessible through a link posted on the "Events and Presentations" section of the Coherus’ investor website: View Source A replay of the presentation will be available on this same website for approximately 90 days.

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BridgeBio Initiates Long Term Debt Management Strategy and Announces Proposed Offering of Convertible Senior Notes to Refinance Senior Secured Debt

On February 24, 2025 BridgeBio Pharma, Inc. (Nasdaq: BBIO) (the "Company," "we" or "BridgeBio") reported that it intends to offer, subject to market conditions and other factors, $500 million aggregate principal amount of convertible senior notes due 2031 (the "notes") in a private offering (the "offering") to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, BridgeBio, FEB 24, 2025, View Source [SID1234650485]). In connection with the offering, the Company expects to grant the initial purchasers an option to purchase up to an additional $75 million aggregate principal amount of notes.

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The Company intends to use a portion of the net proceeds from the offering to repay all outstanding borrowings under and terminate its Financing Agreement, dated as of January 17, 2024, with the lenders party thereto and Blue Owl Corporation, as administrative agent, as amended (the "Financing Agreement"), and pay any fees related thereto. The termination of the Financing Agreement, which accounted for approximately $51.5 million of cash paid for interest in 2024 and contains various restrictive covenants, will provide the Company with reduced pro forma interest expense and greater operational flexibility. The Company intends to use up to $50 million of any remaining net proceeds from the offering to repurchase shares of its common stock from certain purchasers of the notes in privately negotiated transactions effected through one or more of the initial purchasers or an affiliate thereof concurrently with the pricing of the notes (such transactions, the "share repurchases"), together, if necessary, with cash on hand. The Company expects to use any remaining net proceeds from the offering for general corporate purposes.

The Company expects the purchase price per share of its common stock in the share repurchases to equal the last reported sale price per share of its common stock on the Nasdaq Global Select Market as of the date of the pricing of the notes. The share repurchases could increase (or reduce the size of any decrease in) the market price of the Company’s common stock prior to, concurrently with or shortly after the pricing of the notes, and could result in a higher effective conversion price for the notes. The Company cannot predict the magnitude of such market activity or the overall effect it will have on the market price of the notes and/or the market price of the Company’s common stock.

The final terms of the notes, including the initial conversion rate, interest rate and certain other terms, will be determined at the time of pricing. The notes will bear interest semi-annually and will mature on March 1, 2031, unless earlier converted, redeemed or repurchased. Prior to December 2, 2030, the notes will be convertible only upon satisfaction of certain conditions and during certain periods. Thereafter, the notes will be convertible at any time until the close of business on the second scheduled trading day immediately preceding the maturity date. The notes will be convertible at the option of the holders, subject to certain conditions and during certain periods, into cash, shares of the Company’s common stock or a combination of cash and shares of the Company’s common stock, with the form of consideration determined at the Company’s election.

The Company may not redeem the notes prior to March 6, 2028. On or after March 6, 2028 and on or before the 41st scheduled trading day immediately before the maturity date of the notes, the Company may redeem for cash all or any portion of the notes, at its option at any time, and from time to time, if the last reported sale price per share of the Company’s common stock exceeds 130% of the conversion price for a specified period of time and certain other conditions are satisfied. The redemption price will be equal to 100% of the principal amount of the notes being redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. Holders of the notes will have the right to require the Company to repurchase all or a portion of their notes at 100% of their principal amount, plus any accrued and unpaid interest, upon the occurrence of certain events.

When issued, the notes will be the Company’s senior unsecured obligations and will rank senior in right of payment to any of the Company’s unsecured indebtedness that is expressly subordinated in right of payment to the notes; equal in right of payment to any of the Company’s unsecured indebtedness that is not so subordinated; effectively junior in right of payment to any of the Company’s secured indebtedness and obligations, to the extent of the value of the assets securing such indebtedness; and structurally junior to all indebtedness and other liabilities (including trade payables) of the Company’s subsidiaries.

The notes and the shares of common stock issuable upon conversion of the notes, if any, are not being registered under the Securities Act, or the securities laws of any other jurisdiction. The notes and the shares of common stock issuable upon conversion of the notes, if any, may not be offered or sold in the United States except in transactions exempt from, or not subject to, the registration requirements of the Securities Act and any applicable state securities laws.

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

Myriad Genetics Partners with PATHOMIQ to add Artificial Intelligence Technology Platform to its Oncology Portfolio

On February 24, 2025 Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostic testing and precision medicine, and PATHOMIQ, Inc., a developer of artificial intelligence (AI)-enabled prognostic and predictive tests for advancing access to personalized medicine and empowering treatment decisions, reported that they have entered into a strategic collaboration for Myriad to exclusively license PATHOMIQ_PRAD, PATHOMIQ’s AI technology platform for prostate cancer, in the United States (Press release, Myriad Genetics, FEB 24, 2025, View Source [SID1234650509]).

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Machine learning and AI-enabled diagnostics are transforming the way clinicians approach cancer patient care. Adding PATHOMIQ_PRAD to Myriad’s Oncology Solutions allows Myriad to provide urologist and radiation oncologists with molecular and AI-powered testing solutions to inform decisions both before treatment at the time of biopsy for active surveillance and following surgery or radiation treatment. This complements Myriad’s existing offerings of combined germline and comprehensive tumor profiling as recommended by NCCN guidelines for prostate cancer care.

"Along with our Prolaris Prostate Cancer Prognostic Test, we are pleased to leverage PATHOMIQ’s prognostic and predictive capabilities across different phases of the patient journey in prostate cancer," said George Daneker, Jr., MD, President and Chief Clinical Officer, Oncology, Myriad Genetics. "Having both genetic and morphologic insights at the time of biopsy combined with the enhanced ability to predict disease recurrence after initial therapy can lead to more informed treatment decisions and enhance the potential for better patient outcomes. This partnership is the latest step in the strategic expansion of Myriad’s oncology portfolio. Our molecular science expertise, combined with the latest in machine learning and AI, will uniquely position Myriad to deliver higher-quality insights for patients and clinicians in the fight against cancer."

PATHOMIQ’s AI-technology platform decodes hidden information from complex morphological structures across all landscapes of cancer pathology to quickly and efficiently deploy new use cases to predict patient outcome, treatment response, and genotype mutations. This image-based technology can deliver results in one to two days after receiving the digital images from the patient’s sample.

"I am excited to have co-developed, with the PATHOMIQ team, the PATHOMIQ-PRAD AI model for prostate cancer treatment response prediction and identification of high-risk prostate cancer patients who will experience early metastasis post Radical Prostatectomy," said Ashutosh K. Tewari, Chairman, Milton and Carroll Petrie Department of Urology at the Icahn School of Medicine at Mt Sinai. "The AI model has achieved high prediction accuracy and outperformed some of the currently used markers in both Caucasian and African American patient cohorts for a much-improved patient outcome."

In addition to expanding Myriad’s prostate cancer testing portfolio to include post-surgical treatment testing solutions, the collaboration with PATHOMIQ is also envisioned to accelerate the timelines for meeting Simon level 1 evidence for both Prolaris and PATHOMIQ_PRAD. While the current PATHOMIQ_PRAD model is specific for use in patients with prostate cancer after surgery, the underlying foundational model provides opportunities for applications in virtually all solid tumor cancers that are diagnosed through a biopsy with H&E staining.

"Our collaboration with Myriad, a leader in cancer diagnostic tests, will help to advance precision medicine and improve prostate cancer disease outcomes," said Rajat Roy, CEO and co-founder of PATHOMIQ. "Our AI-powered model has been successfully validated across multiple medical institutions and pharmaceutical partners. Combining Myriad’s extensive clinical expertise and broad customer reach with PATHOMIQ’s AI technology platform will allow more personalized treatment options for clinicians and their patients."

Paul J. Diaz, President and CEO of Myriad, adds "PATHOMIQ’s technology platform, together with Myriad’s infrastructure and commercial capabilities allows for an accelerated pace of innovation to bring advanced diagnostic products to market that are clinically validated with faster turnaround times and at a lower cost."

Myriad intends to commercially launch its first AI-driven prostate cancer clinical test later this year.