Reata Pharmaceuticals Announces Participation in the Citi 17th Annual BioPharma Conference

On September 6, 2022 Reata Pharmaceuticals, Inc. (Nasdaq: RETA) ("Reata," the "Company," or "we"), a clinical-stage biopharmaceutical company, reported that management will participate in investor meetings at the Citi 17th Annual BioPharma Conference on September 7 – 8, 2022 in Boston, Massachusetts (Press release, Reata Pharmaceuticals, SEP 6, 2022, View Source [SID1234619175]).

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Cytokinetics to Participate in Upcoming Investor Conferences

On September 6, 2022 Cytokinetics, Incorporated (Nasdaq: CYTK) reported that the company is scheduled to participate in the following investor conferences (Press release, Cytokinetics, SEP 6, 2022, View Source [SID1234619173]):

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Morgan Stanley 20th Annual Global Healthcare Conference on Monday, September 12, 2022 at 8:10 AM ET in a fireside chat with Fady I. Malik, M.D., Ph.D., Executive Vice President of Research and Development, and Andrew Callos, Chief Commercial Officer, at the Sheraton New York.
H.C. Wainwright 24th Annual Global Investment Conference on Tuesday, September 13, 2022 at 12:30 PM ET in a presentation with Fady I. Malik, M.D., Ph.D., Executive Vice President of Research and Development, at the Lotte New York Palace Hotel.
Interested parties may access the live webcast of these presentations by visiting the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. The webcast replay will be archived on the Presentations page within the Investors & Media section of Cytokinetics’ website for 90 days following the conclusion of the event.

Equillium to Acquire Metacrine in All-Stock Transaction

On September 6, 2022 Equillium, Inc. (Nasdaq: EQ) and Metacrine Inc. (Nasdaq: MTCR), reported that the two companies have entered into a definitive merger agreement pursuant to which Equillium will acquire Metacrine in an all-stock transaction (Press release, Equillium, SEP 6, 2022, View Source [SID1234619165]). The transaction is anticipated to add $33 million in cash to Equillium’s balance sheet at closing, which is expected to extend the company’s cash runway into 2024. The transaction has been approved by the boards of directors of both companies.

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"The acquisition of Metacrine meaningfully strengthens Equillium’s cash position," said Bruce Steel, chief executive officer at Equillium. "As we continue to execute on our ongoing clinical development programs this cash runway extension is expected to see us through multiple data catalysts and operational milestones, including our interim data readout from the Type B portion of the EQUALISE study in lupus nephritis patients in the coming weeks followed by topline data in 2023; the initiation of a Phase 2 clinical study of EQ101 in alopecia areata; initiation of a Phase 1 SAD/MAD study of EQ102 in normal healthy volunteers and celiac patients; and interim data from both EQ101 and EQ102. While prioritizing our ongoing studies, we will carefully evaluate strategic partnership options to advance the acquired MET642 program, an orally delivered Phase 2 ready FXR agonist program in ulcerative colitis. Dr. Preston Klassen, president and CEO of Metacrine, is ideally suited to help us in this endeavor and we are pleased to announce his appointment to Equillium’s Board of Directors in conjunction with the closing of the transaction."

"I’m honored to be joining this experienced and talented team," said Preston Klassen, M.D., MHS, president and chief executive officer of Metacrine. "I look forward to working with the Equillium team to advance their exciting pipeline of clinical programs and explore strategic opportunities for MET642. I strongly believe that Metacrine shareholders will benefit from long-term value created by the combination of our companies."

Through the acquisition, Equillium adds Metacrine’s farnesoid X receptor (FXR) platform, including lead molecule MET642, an orally delivered FXR agonist that is a potential first-in-class, non-immunosuppressive treatment for inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn’s disease. MET642 is expected to address multiple aspects of IBD pathogenesis including maintenance of epithelial barrier function and reduction of bacterial translocation. Equillium will be seeking a strategic partner with which to advance this program.

Transaction Details

The transaction consideration will be comprised entirely of stock, where Equillium will issue stock valued at a 25% premium over the net cash delivered at closing, which is estimated to be approximately $26 million. Net cash is total cash, cash equivalents, and short-term investments, adjusted by certain factors including debt, which includes term debt with an outstanding principal of $15 million, and other liabilities, as defined in the merger agreement. The stock value will be based on Equillium’s 10-day volume weighted average closing price calculated ten trading days prior to closing, subject to a share price collar ranging from $2.70 to $4.50. In addition, Equillium has agreed to terms on an amended debt facility with Metacrine’s current lender, K2 HealthVentures LLC, whereby Equillium would assume Metacrine’s existing loan with an outstanding principal balance of $15 million, along with potential access to an additional $10 million of committed debt capital. Concurrent with the transaction closing, Equillium intends to retire its existing debt facility with Oxford Finance LLC and SVB, which currently has an outstanding principal balance of $10 million. After paying off its existing debt facility, Equillium expects to add an estimated $33 million of cash to its balance sheet at closing. Equillium is not planning to retain any current Metacrine employees and expects to assume minimal operating expenses while maintaining sole discretion over the timing and extent of advancing development of the Metacrine programs. The acquisition is anticipated to close late 2022 pending approval from both Equillium and Metacrine shareholders, Metacrine having minimum net cash of $23 million, and other customary closing conditions. Preston Klassen, M.D., MHS, has served as president and chief executive officer and as a member of the board of directors of Metacrine since June 2020. From March 2017 to June 2020, Dr. Klassen served as executive vice president, head of research and development and chief medical officer of Arena Pharmaceuticals, Inc. From June 2016 to March 2017, he was chief medical officer of Laboratoris Sanifit S.L., and from November 2009 to May 2016, was executive vice president, head of global development at Orexigen Therapeutics, Inc. Dr. Klassen also held several positions of increasing responsibility at Amgen Inc., including therapeutic area head for nephrology. Before joining Amgen, he was a faculty member in the Division of Nephrology at Duke University Medical Center. Dr. Klassen received his medical degree from the University of Nebraska College of Medicine, completed his residency in internal medicine, fellowship in nephrology, and Master of Health Sciences degree at Duke University and holds a B.S. in Chemistry from Central University of Iowa.

Webcast and Conference Call

Management will host a conference call accompanied by a slide presentation to discuss the acquisition of Metacrine for analysts and institutional investors, at 8:30 am ET tomorrow, September 7, 2022. To access the call, please dial (888) 350-3846 or (646) 960-0251 and, if needed, provide confirmation number 8770084. A live webcast of the call will also be available on the company’s Investor Relations page at View Source The webcast will be archived for 180 days.

MTS Securities LLC is serving as Metacrine’s financial advisor for the transaction.

Additional Information and Where to Find it

This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval with respect to the proposed merger or otherwise. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended. In connection with Metacrine, Inc.’s pending acquisition by Equillium, Inc., Equillium will file a registration statement on Form S-4 containing a joint proxy statement/prospectus of Equillium and Metacrine and other documents concerning the proposed merger with the Securities and Exchange Commission (the "SEC"). EQUILLIUM URGES INVESTORS TO READ THE JOINT PROXY STATEMENT/PROSPECTUS AND THESE OTHER MATERIALS CAREFULLY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT EQUILLIUM, METACRINE AND THE PROPOSED MERGER. Investors may obtain free copies of the joint proxy statement/prospectus (when available) and other documents filed by Equillium and Metacrine with the SEC at the SEC’s website at www.sec.gov. Free copies of the joint proxy statement/prospectus (when available) and Equillium’s other SEC filings are also available on Equillium’s website at View Source
Equillium, Metacrine and their respective directors, executive officers, certain members of management and certain employees may be deemed, under SEC rules, to be participants in the solicitation of proxies with respect to the proposed merger. Information regarding Equillium’s officers and directors is included in Equillium’s Definitive Proxy Statement on Schedule 14A filed with the SEC on April 13, 2022 with respect to its 2022 Annual Meeting of Stockholders. This document is available free of charge at the SEC’s website at www.sec.gov or by going to Equillium’s Investors page on its corporate website at View Source Information regarding Metacrine’s officers and directors is included in Metacrine’s Definitive Proxy Statement on Schedule 14A filed with the SEC on April 7, 2022 with respect to its 2022 Annual Meeting of Stockholders. This document is available free of charge at the SEC’s website at www.sec.gov or by going to Metacrine’s Investors page on its corporate website at www.Metacrine.com. Additional information regarding the persons who may, under the rules of the SEC, be deemed participants in the solicitation of proxies in connection with the proposed Merger, and a description of their direct and indirect interests in the proposed Merger, which may differ from the interests of Equillium’s stockholders or Metacrine’s stockholders generally, will be set forth in the joint proxy statement/prospectus when it is filed with the SEC.

About Itolizumab

Itolizumab is a clinical-stage, first-in-class anti-CD6 monoclonal antibody that selectively targets the CD6-ALCAM pathway. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited.

About Multi-Cytokine Platform: EQ101 & EQ102

Our proprietary multi-cytokine platform (MCP) generates rationally designed composite peptides that selectively block key cytokines at the shared receptor level targeting pathogenic cytokine redundancies and synergies while preserving non-pathogenic signaling. This approach provides multi-cytokine inhibition at the receptor level and is expected to avoid the broad immuno-suppression and off-target safety liabilities that may be associated with other therapeutic classes, such as JAK inhibitors. Many immune-mediated diseases are driven by the same combination of dysregulated cytokines, and we believe identifying the key cytokines for these diseases will allow us to target and develop customized treatment strategies for multiple autoimmune and inflammatory diseases. Current MCP assets include EQ101, a first-in-class, tri-specific inhibitor of IL-2, IL-9 and IL-15, and EQ102, a first-in-class, selective inhibitor of IL-15 and IL-21.

Cancer Research Institute to Host Second Annual Spanish-Language Virtual Immunotherapy Patient Summit

On September 6, 2022 The Cancer Research Institute (CRI), a nonprofit organization spearheading transformative research to harness the immune system’s power to control and potentially cure all cancers, reported that it will offer its second annual CRI Virtual Immunotherapy Patient Summit in Spanish on September 22, 2022, 2-5 p.m. ET (Press release, Cancer Research Institute, SEP 6, 2022, View Source [SID1234619134]). This free virtual event, moderated by TV Host and Entrepreneur Ana Patricia Gámez, and presented completely in Spanish, will connect Hispanic cancer patients and caregivers with groundbreaking research updates from leading immunotherapy experts driving scientific breakthroughs and advancements that impact patient care.

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According to the Center for Disease Control (CDC), cancer is the leading cause of death among Hispanic people, with current cancer research and statistics indicating a higher incidence of liver cancer, stomach cancer, and cervical cancers in the Hispanic population. With harrowing statistics like, 1 in 3 Hispanic men and women will be diagnosed with cancer in their lifetime, and 1 in 5 men and 1 in 7 women will die from the disease, CRI continues its commitment to empower the U.S. Hispanic cancer community and help create a world immune to cancer.

Cancer immunotherapy is a form of cancer treatment that uses the body’s own immune system to control and eliminate cancer. CRI is bringing the promise of immunotherapy to the underserved Spanish-speaking U.S. Hispanic community with in-language research, information, and direct access to clinical trials, to ultimately improve treatment outcomes for this patient group. CRI offers free clinical trial consultations where a professional will walk patients and their families through their immunotherapy clinical trial options. In addition, CRI will be developing content and news bites in Spanish from leading members of the CRI scientist community, sharing Hispanic-relevant information and patient stories.

"Understanding a cancer diagnosis and treatment options are a vital part of a patient success story, said Dr. Kurt Schalper, associate professor of pathology and medicine (medical oncology), Yale School of Medicine, director of the Translational Immuno-Oncology Laboratory, Yale Cancer Center, and CRI Virtual Immunotherapy Patient Summit keynote speaker. "There is an undeniable need to make information available in-language for Spanish-speaking cancer patients and caregivers. Knowledge and access to data are key components for patients to advocate for themselves and make informed choices. I am honored to be a part of CRI’s second annual Cancer Immunotherapy Summit to help benefit the U.S. Hispanic cancer community."

An early diagnosis can make the difference between life and death, and overall Hispanic men and women are generally less likely to be diagnosed at an early stage, when treatment is usually less intensive and more successful. Over the past two years, the Cancer Research Institute has launched several initiatives to engage Spanish-speaking Hispanic patient and caregiver communities including the development of an immunotherapy patient information hub in Spanish we well as the first all-Spanish language CRI Virtual Immunotherapy Patient Summit, which included an informative session devoted to overcoming racial and ethnic inequalities in access to health information and care.

"Here at the Cancer Research Institute, we continue to work to address barriers that hinder scientific progress and access to Spanish-language health information and care by creating a platform for scientists and patients to share their firsthand experiences at the forefront of cancer immunotherapy research and connect with clinical trials," said Jill O’Donnell-Tormey, Ph.D., CEO and director of scientific affairs at CRI. "We hope to reach and positively impact the U.S. Hispanic cancer community via our in-language CRI Virtual Immunotherapy Patient Summit, and with the integral participation of our media sponsor TelevisaUnivision and host Ana Patricia Gámez.

"I am so very honored to be asked back to moderate the second annual CRI Virtual Immunotherapy Patient Summit in Spanish," said Ana Patricia Gámez, TV host and entrepreneur. "It is a privilege to support Hispanic cancer patients and caregivers in their healthcare journey once again, connecting the community with potentially lifesaving information and access to clinical trials. I do this in loving memory of my father, and I know he would be proud to be a part of such an important program."

"As a journalist, it is my duty to serve my community, and I am deeply grateful for the opportunity to moderate a panel and be a part of the CRI mission to better serve U.S. Hispanic cancer patients and caregivers," said Teresa Rodríguez, host of Univisionarios (Univision News).

"There is a need to engage and help our community overcome barriers to better care and treatments."

From the comfort and safety of home, attendees of the free CRI Virtual Immunotherapy Patient Summit in Spanish can expect to:

Learn the basics of cancer immunotherapy and how it may help them or their loved one.
Hear from and interact with leading physician-scientists with expertise in cancer immunotherapy.
Gain valuable insight into how clinical trials work and to understand whether they are a good option for patients to explore with their healthcare team.
Learn more about the latest research on cancers most affecting the U.S. Hispanic community.
Discover issues specific to U.S. Hispanic communities regarding overall health care and how doctors, organizations, advocates, and individuals are addressing these challenges.
Hear real patients who have undergone immunotherapy treatment tell their story.
Support for the Spanish-language 2022 CRI Virtual Immunotherapy Patient Summit is generously provided by the following sponsors:

Official Media Sponsor: TelevisaUnivision

The Cancer Research Institute has pledged to help close the information and research gap and better serve the Spanish-speaking U.S. Hispanic community. Visit cancerresearch.org/es to see the robust and helpful offering of information now available in Spanish. Visit cancerresearch.org/es/conferencia to register for the free Spanish-language 2022 CRI Virtual Immunotherapy Patient Summit.

Immutep Announces Investigator-Initiated Phase II Trial Evaluating LAG3 Candidate Eftilagimod Alpha (Efti) in Soft Tissue Sarcoma

On September 6, 2022 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), reported it has signed a Material Transfer Agreement ("Agreement") with the Maria Skłodowska-Curie National Research Institute of Oncology in Warsaw, Poland to enable an investigator-initiated open label Phase II clinical trial (Press release, Immutep, SEP 6, 2022, View Source [SID1234619129]). The trial will evaluate Immutep’s lead product candidate efti in combination with pembrolizumab and radiotherapy in the neoadjuvant setting (prior to surgery) in up to 40 patients with select soft tissue sarcoma (STS).

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Subject to the necessary approvals from the Polish State Institute for Drug Control and ethics committee, the dosing of the first patient is anticipated in the first half of calendar year 2023, with initial interim data expected in the fourth quarter of CY 2024.

Under the Agreement, the Maria Skłodowska-Curie National Research Institute of Oncology will primarily fund the study with an approved grant from the Polish government of €1.5M (~A$2.2M) awarded by the Polish Medical Research Agency program. Immutep will provide efti at no cost to the Maria Skłodowska-Curie National Research Institute of Oncology and will technically support the trial. The trial will be led by Principal Investigators, Dr. Katarzyna Kozak, M.D. PhD., and Paweł Sobczuk, M.D., medical oncologists at the Department of Soft Tissue/Bone Sarcoma and Melanoma at the Maria Skłodowska-Curie National Research Institute of Oncology.

Immutep CEO, Marc Voigt, said: "We were delighted to be approached by Dr Paweł Sobczuk and Dr. Katarzyna Kozak to form this collaboration with the Maria Skłodowska-Curie National Research Institute of Oncology to explore the potential of efti in combination with pembrolizumab and radiotherapy in soft tissue sarcoma. We thank the Polish government for granting €1.5M in non-dilutive cash funding for this trial. Recurrence and lack of deep and durable responses are challenges with the limited standards of care available for this rare and difficult-to-treat disease. Efti’s novel mechanism of action offers potential to enhance anti-tumour responses for these patients. This latest expansion of the efti pipeline is further evidence of the increased interest from a variety of interested parties to investigate the broad potential of efti to improve patient outcomes in yet another cancer indication and treatment regimen."

Immutep CSO and CMO, Dr Frederic Triebel said: "Efti stimulates the immune system through a differentiated mechanism that targets LAG-3-driven activation of antigen-presenting cells. By working upstream of T cells, efti has potential to generate a broad and robust anti-tumour immune response even in the immunosuppressed tumour microenvironment of soft tissue sarcomas. Therefore, we are very pleased to be collaborating with our colleagues at the Maria Skłodowska-Curie National Research Institute of Oncology."

Maria Skłodowska-Curie National Research Institute of Oncology, Medical Oncology Fellow and Co-Principal Investigator, Dr. Paweł Sobczuk said: "The need for new approaches in this rare and aggressive disease is evident by the still dismal responses with current standards of care including surgery, radiotherapy and chemotherapy. Clinical data in other solid tumours suggest that efti can synergize with radiotherapy and pembrolizumab for robust responses across PD-L1 status, supporting the potential of this combination to mount effective immunity against aggressive malignancies like soft tissue sarcoma and replace the need for chemotherapy."

Efti’s Mechanism of Action

Efti is a first-in-class antigen presenting cell (APC) activator currently being developed by Immutep for the treatment of cancer. Efti binds to antigen presenting cells such as dendritic cells, monocytes and macrophages via MHC II molecules. This activates the APCs causing them to become professional antigen presenting cells, thereby presenting antigen to the adaptive immune system. This leads to activation and proliferation of CD4+ (helper) and CD8+ (cytotoxic) T cells. Thus, the aim of efti is to "push the gas" on the body’s innate and adaptive immune systems making it a suitable candidate to evaluate not only for the treatment of cancer, but also for the treatment of infectious diseases.