CASI PHARMACEUTICALS ENTERS INTO SUBLICENSE AGREEMENT WITH TIANSHI PHARMACEUTICALS FOR ANTI-CD38 MONOCLONAL ANTIBODY (MAB) CID-103 IN AUTOIMMUNE FIELD

On May 24, 2022 CASI Pharmaceuticals, Inc. (NASDAQ: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported the signing of a Sublicense Agreement with Beijing Tianshi Tongda Pharmaceuticals Technology Co., Ltd., ("TIANSHI") a clinical stage pharmaceutical company organized and existing under the laws of the People’s Republic of China ("PRC") (Press release, CASI Pharmaceuticals, MAY 24, 2022, View Source [SID1234615009]). The Sublicense Agreement grants TIANSHI an exclusive, perpetual, worldwide license for the investigational anti-CD38 monoclonal antibody (Mab), CID-103, in the treatment, prevention, and diagnosis of autoimmune diseases, conditions, and disorders in humans.

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Under the terms of the agreement, CASI shall maintain the exclusive commercialization and co-marketing rights of CID-103 in autoimmune indications and book all revenue in the United States. CASI has the co-commercial rights in autoimmune-derived hematology and oncology indications of CID-103 in China, but not obligated to co-commercialize those programs.

As part of the agreement, TIANSHI agreed to pay CASI a $10 million upfront payment in two instalments, as well as certain future milestone and royalty payments. Following the execution of this agreement, TIANSHI will complete its first equity financing. Upon completion of such equity financing, CASI, through its wholly-owned PRC subsidiary, will hold 15% equity of TIANSHI, which is expected to receive 120 million RMB from two venture capital investors and 20 million RMB from CASI Pharmaceuticals (China) Co., Ltd.

Wei-Wu He, Ph.D., CASI’s Chairman and Chief Executive Officer, commented, "Recent research reveals that anti-CD38 antibodies can play a role in the treatment of diseases beyond hematological malignancies, which include pathologic antibody-mediated autoimmune diseases. We are excited by this development and potential opportunity to maximize the clinical usefulness of CID-103. We are pleased to have entered this agreement with TIANSHI, which may benefit more patients and allow CASI to maintain its focus on the hematology-oncology space."

Dr. He continued, "CASI is a company with a high entrepreneurial spirit. We have a unique business model and equity investment philosophy. This transaction demonstrates our commitment to our business partners and patients. In addition to sublicense agreement, CASI entered into an investment agreement with TIANSHI. CASI will subscribe to 15% of TIANSHI’s equity at the price of 20 million RMB (approx. $3 million) because we firmly believe that with the implementation of precision diagnostics, treatment of autoimmune disorders with innovative medicines has a bright prospect. The sublicense agreement and equity investment in TIANSHI are mutually beneficial for both parties, and we anticipate the positive clinical results of CID-103 in both multiple myeloma and autoimmune disease fields."

About CID-103 (Anti-CD38 Mab)

CID-103 is a fully human IgG1 anti-CD38 monoclonal antibody that recognizes a unique epitope on CD38. It was engineered to have strong activity against CD38 malignant cells and to reduce certain safety issues observed with existing treatments. Preclinical data of CID-103 demonstrates enhanced activity against a broad array of malignancies which express CD38 and demonstrates a better preclinical safety profile when compared to other CD38 mAbs. These attributes offer the potential for accelerated development and regulatory review, including rapid advancement into earlier lines of therapy.

PreludeDx™ to Present DCIS Study Results Assessing Benefit of Adjuvant Endocrine Therapy Using DCISionRT® During Oral Presentation at ASCO 2022 Annual Meeting

On May 24, 2022 Prelude Corporation (PreludeDx), a leader in molecular diagnostics and precision medicine for early-stage breast cancer, reported that its study in 926 DCIS patients demonstrating the clinical utility of DCISionRT was selected for an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Prelude Therapeutics, MAY 24, 2022, View Source [SID1234615008]). The results evaluating the association of DCISionRT, a predictive DCIS Biosignature to assess the impact of Endocrine Therapy (ET) on 10-year ipsilateral breast recurrence (IBR) risk after breast conserving surgery alone or with radiation therapy (RT), will be presented on June 7, 2022 at McCormick Place, Chicago, IL.

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"We continue to expand the clinical evidence and utility of DCISionRT and are excited to have been selected for oral presentation at the prestigious ASCO (Free ASCO Whitepaper) Annual Meeting," said Dan Forche, President and CEO of PreludeDx. "These results amplify the extensive body of clinical evidence empowering physicians and patients to make personalized early-stage breast cancer treatment decisions and enhance patient outcomes."

Oral Abstract Presentation
Title: Assessing the benefit of adjuvant endocrine therapy in patients following breast conserving surgery with or without radiation stratified by a 7-gene predictive DCIS biosignature
Presenter: Pat Whitworth, MD, FACS, FSSO, Nashville Breast Center, and Associate Professor, University of Tennessee
Location: Hall D1
Date: Tuesday, June 7, 9:57 am CDT

About DCISionRT for Breast DCIS
DCISionRT is the only risk assessment test for patients with ductal carcinoma in situ (DCIS) that predicts radiation therapy benefit. Patients with DCIS have cancerous cells lining the milk ducts of the breast, but they have not spread into surrounding breast tissue. In the US, over 60,000 women are newly diagnosed with DCIS each year. DCISionRT, developed by PreludeDx on technology licensed from the University of California San Francisco, and built on research that began with funding from the National Cancer Institute, enables physicians to better understand the biology of DCIS. DCISionRT combines the latest innovations in molecular biology with risk-based assessment scores to assess a woman’s individual tumor biology along with other pathologic risk factors and provide a personalized recurrence risk. The test provides a Decision Score that identifies a woman’s risk as low or elevated. Unlike other risk assessment tools, the DCISionRT test combines protein expression from seven biomarkers and four clinicopathologic factors, using a non-linear algorithm to account for multiple interactions between individual factors in order to better interpret complex biological information. DCISionRT’s intelligent reporting provides a woman’s recurrence risk after breast conserving surgery alone and with the addition of radiation therapy. In turn, this new information may help patients and their physicians to make more informed treatment decisions.

CNS Pharmaceuticals Announces Presentation at the H.C. Wainwright Global Investment Conference

On May 24, 2022 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, reported that John Climaco, Chief Executive Officer of CNS Pharmaceuticals, will be participating at the H.C. Wainwright Global Investment Conference being held May 23-26, 2022 in Miami, FL and virtually (Press release, CNS Pharmaceuticals, MAY 24, 2022, https://www.prnewswire.com/news-releases/cns-pharmaceuticals-announces-presentation-at-the-hc-wainwright-global-investment-conference-301553649.html [SID1234615007]).

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A video webcast of Mr. Climaco’s presentation is now accessible for viewing on-demand for those registered for the event and will be available on the Events page in the Investors section of the Company’s website (www.cnspharma.com). The webcast replay will be archived for 90 days following the event.

In addition to the presentation, management will be available to participate in virtual one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information, please visit the conference website.

Myeloid Therapeutics to Participate at Investor Conferences in June 2022

On May 24, 2022 Myeloid Therapeutics, Inc. ("Myeloid"), a clinical stage mRNA-immunotherapy company developing novel therapies for cancer and autoimmune diseases, reported that it will participate in the following investor conferences during June 2022 (Press release, Myeloid Therapeutics, MAY 24, 2022, View Source [SID1234615006]):

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Wells Fargo Private Biotech Symposium, taking place virtually on June 1, 2022
Jefferies Healthcare Conference, taking place in New York, NY, June 8-10th, 2022. Daniel Getts, Ph.D., CEO of Myeloid, will present a company overview on Friday, June 10th, at 12:15 pm ET.

Neurocrine Biosciences Announces Repurchase of Convertible Notes

On May 24, 2022 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) (the "Company" or "Neurocrine Biosciences") reported that it has entered into separate, privately negotiated transactions (the "Agreements") with certain holders of its existing 2.25% Convertible Senior Notes due 2024 (the "2024 Notes") to repurchase approximately $179.4 million aggregate principal amount of the 2024 Notes for an aggregate repurchase price of an amount of cash estimated to be the sum of (i) approximately $224.0 million, (ii) an amount based in part on the trading price of the Company’s common stock and (iii) accrued and unpaid interest (Press release, Neurocrine Biosciences, MAY 24, 2022, View Source [SID1234615004]). The 2024 Notes repurchases are expected to close over a period ending on June 14, 2022, subject to customary closing conditions. Such repurchases of the 2024 Notes could affect the market price of the Company’s common stock.

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Following these repurchases, approximately $201.8 million aggregate principal of the Company’s 2024 Notes will remain outstanding, from an initial principal balance of $517.5 million. "Given our balance sheet flexibility, we have now reduced our convertible debt levels by approximately 60% over the past two years in an effort to minimize dilution for our shareholders," said Matt Abernethy, Chief Financial Officer of Neurocrine Biosciences. "Our capital allocation priorities remain focused on growing INGREZZA and advancing our mid-to-late-stage clinical programs."

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