On June 1, 2022 Protagonist Therapeutics, Inc. (Nasdaq: PTGX) ("Protagonist" or "the Company") reported that Dinesh V. Patel, Ph.D., President, and Chief Executive Officer, will present at the Jefferies Healthcare Conference in New York on Wednesday, June 8 at 9:30 a.m. ET (Press release, Protagonist, JUN 1, 2022, View Source [SID1234615389]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A webcast of the event will be available for 90 days on the Investors section of the Protagonist Therapeutics website at View Source

On June 1, 2022 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine company pioneering the discovery and development of MasterKey therapies, reported the appointment of Sergey Yurasov, M.D., Ph.D., as Chief Medical Officer (Press release, Black Diamond Therapeutics, JUN 1, 2022, View Source [SID1234615320]). In conjunction with the appointment of Dr. Yurasov, Karsten Witt, M.D., is transitioning from his current role as the Company’s Interim Chief Medical Officer to a clinical advisory role.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are delighted to welcome Sergey to Black Diamond as Chief Medical Officer. His considerable expertise in precision oncology medicine, specifically with epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC) and glioblastoma multiforme (GBM), positions Sergey as an invaluable leader for our drug development team," said David Epstein, Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. "We remain focused on advancing our MasterKey therapies, including our lead clinical program, BDTX-1535, and BDTX-4933, currently in IND-enabling studies, and Sergey’s diverse clinical and regulatory experience in the development of targeted oncology therapies for the treatment of solid tumors will be essential as we further advance our pipeline and utilize our innovative MAP drug discovery engine to develop novel MasterKey therapies."

Dr. Yurasov joins Black Diamond Therapeutics from Nuvation Bio, an oncology therapeutics company. As Chief Medical Officer at Nuvation Bio, Dr. Yurasov was instrumental in the company’s successful public offering in February 2021, and spearheaded the company’s clinical development strategy in multiple oncology indications for a number of small molecule programs. Prior to Nuvation Bio, Dr. Yurasov was the Chief Medical Officer and Senior Vice President of Clinical Development at Immune Design Corp., an immune-oncology company, which was acquired by Merck in March 2019. He was previously Senior Vice President of Clinical Development at Clovis Oncology, where he oversaw clinical development and led clinical teams through regulatory filings for multiple oncology development programs, including rociletinib for epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC) and RUBRACA (rucaparib) for homologous-recombination deficient ovarian cancer. Earlier in Dr. Yurasov’s career, he was a senior physician at ImClone Systems, a subsidiary of Eli Lilly and Company, leading the approval of CYRAMZA (ramucirumab) in NSCLC and a clinical lead on multiple oncology early development programs at Roche. Dr. Yurasov holds an M.D. from the Russian State Medical University and a Ph.D. from the Research Institute for Pediatric Hematology, in Moscow, Russia.

"Black Diamond’s MAP drug discovery engine represents a novel approach to addressing major unmet medical needs for patients within the precision oncology treatment landscape by targeting overlooked mutation families, and I was particularly drawn to this differentiated way of tackling the gaps in genetically defined cancer treatment. I am excited to be joining this team to further execute on the development of Black Diamond’s pipeline programs as the Company prepares for key milestones across its programs in 2023," said Dr. Yurasov. "This is a crucial time for Black Diamond with a newly refined pipeline strategy and clear prioritization of programs in development and I look forward to joining this fantastic group of leaders and scientists as we work together to expand the reach of precision medicines in oncology."

Dr. Yurasov succeeds Dr. Witt, who was Black Diamond’s founding Chief Medical Officer and will continue to support the Company in an advisory capacity.

"On behalf of everyone at Black Diamond, the management team and Board of Directors, we thank Karsten for his significant contributions to our progress and mission of expanding the reach of precision cancer medicines. Karsten has been instrumental in the building of Black Diamond, and we are grateful for the integral role he has played in our growth. I want to thank him for his leadership and continued commitment to the value proposition of MasterKey therapies," said Dr. Epstein.

On June 1, 2022 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for serious rare and ultra-rare genetic diseases, reported that Emil D. Kakkis, M.D., Ph.D., the company’s Chief Executive Officer and President, will present at the Jefferies Global Healthcare Conference on Wednesday, June 8, 2022, at 2:30 PM ET in New York (Press release, Ultragenyx Pharmaceutical, JUN 1, 2022, View Source [SID1234615336]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The live and archived webcast of the presentation will be accessible from the company’s website at View Source The replay of the webcast will be available for 90 days.

On June 1, 2022 Pfizer Inc. (NYSE: PFE) reported an update on its ownership interest in Haleon plc (Haleon), the newly independent company which will hold the joint Consumer Healthcare business of GSK plc (NYSE: GSK) and Pfizer following the demerger of approximately 80% of GSK’s ownership interest in the business to GSK’s shareholders (Press release, Pfizer, JUN 1, 2022, View Source [SID1234615354]). Following the demerger and listing of Haleon on the London Stock Exchange (LSE), which is expected to occur in July 2022, Pfizer will continue to hold a 32% ownership interest in Haleon. However, in keeping with Pfizer’s transformation into a more focused, global leader in science-based innovative medicines and vaccines, the company intends to exit its 32% ownership interest in Haleon in a disciplined manner, with the objective of maximizing value for Pfizer shareholders.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On July 31, 2019, Pfizer and GSK completed a transaction to form a joint venture (JV) that combined their respective Consumer Healthcare businesses. Under the terms of the transaction, Pfizer and GSK received 32% and 68% ownership interests in the JV, respectively. On June 1, 2022, Haleon published a Prospectus in connection with the demerger and LSE listing. GSK and certain related entities will retain, in the aggregate, an approximately 13.6% ownership interest in Haleon following the transaction. In addition, Haleon will soon apply to list American Depositary Shares (ADSs) representing Haleon ordinary shares on the New York Stock Exchange (NYSE). Completion of the demerger and the LSE and NYSE listings are subject to customary conditions, including GSK shareholder approval.

As previously announced, John Young, former Group President and Chief Business Officer – Pfizer, and Bryan Supran, Senior Vice President and Deputy General Counsel – Pfizer, will be appointed to the Haleon Board of Directors upon completion of the demerger.

Morgan Stanley & Co. LLC and Guggenheim Securities, LLC are acting as Pfizer’s financial advisors for this transaction. Wachtell, Lipton, Rosen & Katz and Clifford Chance LLP are serving as Pfizer’s legal advisors, and Skadden, Arps, Slate, Meagher & Flom LLP is serving as its tax advisor for the transaction.

On June 1, 2022 Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, reported its first quarter 2022 unaudited financial results (Press release, Legend Biotech, JUN 1, 2022, View Source [SID1234615373]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The year began with an exciting start as we received the company’s first-ever U.S. FDA approval for CARVYKTI," said Ying Huang, Ph.D., CEO of Legend Biotech. "This is the first of many cell therapies we hope to bring to patients, and we look forward to advancing the CARTITUDE clinical development program and our cell therapy pipeline over the rest of the year."

First Quarter 2022 Highlights and Recent Events

On February 28, 2022, the U.S. Food and Drug Administration (FDA) approved CARVYKTI for the treatment of adults with relapsed or refractory multiple myeloma who have received four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, marking the company’s first product approved by a health authority.
On May 26, 2022, the European Commission (EC) granted conditional marketing authorization of CARVYKTI for the treatment of adults with relapsed and refractory multiple myeloma who have received at least three prior therapies, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD) and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy.
On April 21, 2022, Legend announced the achievement of a $50 million milestone under its collaboration agreement with Janssen Biotech, Inc. (Janssen) for CARVYKTI. Legend Biotech entered into an exclusive worldwide license and collaboration agreement with Janssen to develop and commercialize CARVYKTI in December 2017.
Legend Biotech engaged Ernst & Young LLP, located in the United States, as the company’s independent, registered public accounting firm for the audits of the Company’s financial statements and internal control over financial reporting for the fiscal year ending December 31, 2022.
CARTITUDE-6 (not yet recruiting; sponsored by the European Myeloma Network), a second Phase 3 trial in frontline multiple myeloma, was posted on clinicaltrials.gov. This Phase 3, randomized, open-label study compares daratumumab, bortezomib, lenalidomide and dexamethasone (DVRd) followed by cilta-cel vs. DVRd followed by autologous stem cell transplant (ASCT) in newly diagnosed, transplant-eligible patients with multiple myeloma.
On May 25, 2022, The FDA lifted its clinical hold of Legend Biotech’s Phase 1 clinical trial of LB1901, the company’s investigational autologous chimeric antigen receptor T-cell (CAR-T) therapy targeting malignant CD4+ T-cells for the treatment of adults with relapsed or refractory T-cell lymphoma (TCL).
On March 23, 2022, Legend Biotech was awarded Newcomer of the Year at the tenth annual Foreign Investment Trophy ceremony hosted by Flanders Investment & Trade (FIT) for its joint investment in a state-of-the-art manufacturing facility in Flanders with Janssen Pharmaceutica N.V.
Legend Biotech made the following management appointments: Lori Macomber, CPA, as Chief Financial Officer; Guowei Fang, Ph.D., as Senior Vice President, Global Head of Research and Early Development; and Marc L. Harrison, as Vice President and General Counsel.
Financial Results for First Quarter Ended March 31, 2022

Cash and Cash Equivalents, Time Deposits, and Short-Term Investments

As of March 31, 2022, Legend Biotech had approximately $796.0 million of cash and cash equivalents, deposits and short-term investments.

Revenue

Revenue for the three months ended March 31, 2022 was $40.8 million compared to $13.7 million for the three months ended March 31, 2021. The increase of $27.1 million was primarily due to revenue recognition from additional milestones achieved. Legend Biotech has not generated any revenue from product sales to date.

Research and Development Expenses

Research and development expenses for the three months ended March 31, 2022 were $81.3 million compared to $71.1 million for the three months ended March 31, 2021. This increase of $10.2 million was primarily due to a higher number of clinical trials with more patients enrolled and a higher number of research and development activities in cilta-cel and for other pipelines in the first quarter of 2022.

Administrative Expenses

Administrative expenses for the three months ended March 31, 2022 were $12.7 million compared to $8.7 million for the three months ended March 31, 2021. The increase of $4.0 million was primarily due to Legend Biotech’s expansion of supporting administrative functions to facilitate continuous research and development activities as well as activities to establish elements of a commercialization infrastructure.

Selling and Distribution Expenses

Selling and distribution expenses for the three months ended March 31, 2022 were $21.3 million compared to $13.4 million for the three months ended March 31, 2021. This increase of $7.9 million was primarily due to increased costs associated with commercial preparation activities for cilta-cel.

Other Income and Gains

Other income and gains for the three months ended March 31, 2022 were $1.0 million compared to $0.7 million for the three months ended March 31, 2021. The increase of $0.3 million was primarily due to more interest income earned in first quarter of 2022.

Other Expenses

Other expenses for the three months ended March 31, 2022 were $1.5 million compared to $2.0 million for the three months ended March 31, 2021. The decrease was primarily due to less foreign currency exchange loss in first quarter of 2022.

Finance Costs

Finance costs for the three months ended March 31, 2022 were $1.0 million compared to $0.04 million for the three months ended March 31, 2021. The increase was primarily due to interest for advance funding, which is comprised of interest on interest-bearing borrowings funded by Janssen under the parties’ collaboration agreement.

Fair Value Gain of Warrant Liability

Fair value gain of warrant liability for the year ended March 31, 2022 was $34.9 million caused by changes in the fair value of a warrant that Legend Biotech issued to an institutional investor through a private placement transaction in May 2021 with an initial fair value of $81.7 million at the issuance date. The warrant was assessed as a financial liability with a fair value of $87.9 million as of December 31, 2021 and a fair value of $53.0 million as of March 31, 2022.

Loss for the Period

For the three months ended March 31, 2022, net loss was $41.1 million, or $0.13 per share, compared to a net loss of $80.9 million, or $0.30 per share, for the three months ended March 31, 2021.