Exact Sciences to Participate in March Investor Conferences

On February 24, 2025 Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, reported that company management will participate in the following conferences and invited investors to participate by webcast (Press release, Exact Sciences, FEB 24, 2025, View Source [SID1234650471]).

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TD Cowen Health Care Conference, Boston
Fireside chat on Monday, March 3, 2025 at 10:30 a.m. ET
Raymond James Institutional Investors Conference, Orlando
Presentation on Tuesday, March 4, 2025 at 1:05 p.m. ET
The webcasts can be accessed in the investor relations section of Exact Sciences’ website at www.exactsciences.com.

CytoDyn Announces Promising Survival Observations in mTNBC Patients Treated with Leronlimab

On February 24, 2025 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, reported encouraging survival outcomes among a group of patients with metastatic triple-negative breast cancer ("mTNBC") treated with leronlimab (Press release, CytoDyn, FEB 24, 2025, View Source [SID1234650470]). Although mTNBC typically has a poor prognosis, observed survival rates at 12, 24, and 36 months after treatment with leronlimab compare favorably with reported life expectancy after treatment with currently approved therapies. In addition, the Company confirmed that a small group of patients who failed treatment after developing metastatic disease survived more than 36 months after receiving leronlimab, are alive today, and currently identify as having no evidence of ongoing disease.

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Following the resolution of the Company’s dispute with its former CRO, CytoDyn obtained follow-up records from patients treated with leronlimab during the Company’s prior clinical trials in oncology. After confirming these patient outcomes, CytoDyn worked with consultants and key opinion leaders to summarize the findings and submit an abstract to the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Breast Cancer meeting taking place in Munich, Germany, from May 14 to 17, 2025.

"We are encouraged by the longer-term survival data to pursue this potentially paradigm-shifting therapeutic pathway for patients suffering from metastatic triple-negative breast cancer," said Richard Pestell, MD, PhD, AO, the Company’s Lead Consultant in Preclinical and Clinical Oncology. "As a cancer therapeutic, leronlimab was well tolerated with remarkably infrequent treatment-related adverse events. These promising results suggest further studies with leronlimab are warranted to expand oncology treatment options and improve patient care."

Dr. Jacob Lalezari, CEO of CytoDyn, added: "These provocative observations of improved survival in patients with mTNBC and prior treatment failure in the metastatic setting, including reported clearance of disease in a group of long-term survivors, provides early clinical evidence of leronlimab’s potential impact in the treatment of TNBC and other solid tumors. I expect the Company’s oncology efforts to accelerate in the coming months, with further announcements in both mTNBC and colorectal cancer."

Based on these survival observations, the Company has initiated two pre-clinical studies in mTNBC that will evaluate possible treatment synergies between leronlimab, an antibody-drug complex treatment (sacituzumab govitecan), and an immune checkpoint inhibitor (pembrolizumab). The Company will also continue to perform follow-up testing on the group of mTNBC survivors who currently identify as having no evidence of ongoing disease.

Crinetics Pharmaceuticals Appoints Tobin Schilke as Chief Financial Officer

On February 24, 2025 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), reported the appointment of Tobin "Toby" Schilke as chief financial officer, effective February 28, 2025 (Press release, Crinetics Pharmaceuticals, FEB 24, 2025, View Source [SID1234650469]). Mr. Schilke is a seasoned biopharma executive with over 25 years of global pharmaceutical experience. In prior roles, his leadership was instrumental in transforming several biotech companies from R&D-focused entities into fully integrated commercial organizations.

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"I am excited to welcome Toby to our senior leadership team during this transformational stage of our evolution into a global pharmaceutical company," said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. "Toby’s deep finance experience in commercial-stage global pharmaceutical companies and emerging biotech is essential as we prepare for our first commercial launch and advance numerous promising candidates through development. I would also like to thank Marc Wilson for his invaluable leadership and financial stewardship during his tenure, guiding the company through critical phases of growth."

"I am honored to join Crinetics at such a pivotal time in the company’s journey and am deeply inspired by its mission to improve the lives of people living with endocrine-related conditions," said Mr. Schilke. "I look forward to collaborating with the Crinetics team and stakeholders to accelerate our growth objectives and create long-term value."

Prior to joining Crinetics, Mr. Schilke served as chief financial officer at Revance Therapeutics, where he oversaw finance, investor relations, IT, and technical operations for a public company with 650 employees, supporting the transformation to a commercial company with two product launches and over $700 million in cumulative revenue. Previously, Mr. Schilke served as Chief Financial Officer at Achaogen, where he built out the financial planning and analysis, accounting, procurement, information technology, and facilities management functions to support the approval and launch of the company’s first product. In these roles, Mr. Schilke successfully executed over $1.5 billion in equity, convertible debt, and structured debt financing, while also leading numerous partnerships and M&A deals. Earlier in his career, he spent more than a decade in increasing roles of responsibility at Roche/Genentech in corporate development, commercial finance, marketing and global operations. Mr. Schilke holds a bachelor’s degree in chemical engineering from Lafayette College, a master’s degree in chemical engineering from the University of California, Berkeley, and a master’s degree in business administration from Cornell University.

On March 10, 2025, the Company expects to grant Mr. Schilke 52,000 restricted stock units (RSUs) and a stock option to purchase 80,000 shares of common stock under the Crinetics Pharmaceuticals, Inc. 2021 Employment Inducement Incentive Award Plan (the "2021 Inducement Plan"). The shares subject to the stock options will vest over four years, with 25% of the shares vesting on the one-year anniversary of the applicable vesting commencement date and the balance of the shares vesting in a series of 36 successive equal monthly installments thereafter, subject to each employee’s continued employment with Crinetics on such vesting dates. The RSUs will vest over four years in equal annual installments beginning on the one-year anniversary of the applicable vesting commencement date, also subject to each employee’s continued employment with Crinetics on such vesting dates. The stock option and RSU awards are subject to the terms and conditions of the 2021 Inducement Plan and the terms and conditions of an applicable stock option award agreement or RSU award agreement covering the respective grant. The RSUs and stock option will be granted as an inducement material to Mr. Schilke entering into employment with Crinetics in accordance with Nasdaq Listing Rule 5635(c)(4).

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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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."