On July 27, 2021 Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) reported that it will report its second quarter 2021 financial results after market close on Tuesday, August 3, 2021 (Press release, Rigel, JUL 27, 2021, View Source [SID1234585233]). Rigel senior management will follow the announcement with a live conference call and webcast at 4:30pm Eastern Time (1:30pm Pacific Time) to discuss the financial results and give an update on the business.

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Participants can access the live conference call by dialing 877-407-3088 (domestic) or 201-389-0927 (international). The conference call and accompanying slides will also be webcast live and can be accessed from the Investor Relations section of the company’s website at www.rigel.com. The webcast will be archived and available for replay for 90 days after the call via the Rigel website.

On July 27, 2021 Samsung Biologics (KRX: 207940.KS), the world’s leading contract development and manufacturing organization, reported strong financial results for the second quarter of fiscal 2021 (Press release, Samsung BioLogics, JUL 27, 2021, View Source [SID1234585249]).

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John Rim, CEO of Samsung Biologics, stated, "The second-quarter financial performance demonstrates our ability to maintain steady operations despite the global supply disruptions brought on by the pandemic and our commitment to deliver life-saving treatments to patients at an expedited timeline. Recently, we announced our expansion plans in mRNA vaccine manufacturing, in line with our three-dimensional growth plans laid out earlier on in the year. Construction and presales of our Plant 4 are on track, and we will take on new initiatives as we continue our strong momentum across our business portfolio and growth plans."

SECOND QUARTER 2021 RESULTS

Second quarter 2021 revenue was KRW 412.2 billion, an increase of 34% from KRW 307.7 billion reported for the second quarter in the previous year, attributable to increased utilization of Plant 3 and sales activities bringing in new contracts, including COVID-19 products.

Second quarter 2021 operating profit was KRW 166.8 billion, 105.7% higher than the prior-year period leveraging strong top-line growth.

Second quarter 2021 net profit reached KRW 121.5 billion, an increase of KRW 69.5 billion from KRW 52 billion in the second quarter a year ago, and second quarter 2021 operating margin was at a record-high 40.5% due to increased utilization across all plants and product mix, including fast-turnaround COVID-19 treatments.

FISCAL YEAR 2021 OUTLOOK

The annual revenue is expected to remain steady at the mid-20% range amid full operations at Plants 1 and 2, and near-full operations at Plant 3. The high utilization rate is also expected to drive an increase in the annual operating profit.

The company signed a contract with Moderna in May this year to provide fill-finish manufacturing of its COVID-19 vaccine and announced a plan to add an mRNA vaccine drug substance manufacturing facility to expand its portfolio of services.

Plant 4 construction remains on track with active presales discussions, commencing its partial operations by the end of 2022 and expected to be fully GMP-ready in 2023. The San Francisco R&D Center is also fully equipped for high-quality cell line development in support of client pipelines in close proximity to the U.S. market.

Samsung Biologics has maintained stable business operations with no disruption caused by the pandemic and is currently able to continue as planned with key strategic growth projects and long-term investments.

On July 27, 2021 Kineta, Inc., a clinical stage biotechnology company focused on the development of novel immunotherapies in oncology, reported that it successfully completed a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding the manufacturing, preclinical and clinical development plan for KVA12.1 (Press release, Kineta, JUL 27, 2021, View Source;utm_medium=rss&utm_campaign=kineta-announces-pre-ind-meeting-for-kva12-1 [SID1234585217]). Kineta has gained alignment with FDA on the initial Phase 1/2 clinical trial of the safety and efficacy of Kineta’s KVA12.1 as a single agent and in combination with pembrolizumab in patients with unresectable or metastatic solid tumors.

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"We greatly appreciate the FDA’s guidance as we prepare to advance our novel anti-VISTA immunotherapy into the clinic next year", said Shawn Iadonato, PhD, Chief Executive Officer of Kineta. "The successful completion of this engagement with the FDA is an important milestone that provides regulatory clarity for KVA12.1 and confidence with the planned development program for this novel anti-cancer immunotherapy.

A pre-IND meeting provides an opportunity for an open communication between a drug development company and the FDA to discuss the IND development plan and to obtain the agency’s guidance for clinical studies of the company’s new drug candidate. The FDA reviewed the IND enabling preclinical data, manufacturing plan and phase 1/2 clinical study protocol synopsis for KVA12.1, provided guidance and addressed Kineta’s questions on the development plan. Kineta plans to initiate the Phase 1/2 first-in-human clinical studies in mid-2022.

On July 27, 2021 Prokarium, a biopharmaceutical company pioneering the oncology field of microbial immunotherapy, reported the appointment of Kristen Albright, PharmD, as Chief Executive Officer (Press release, Prokarium, JUL 27, 2021, View Source [SID1234585234]).

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Dr. Albright is an accomplished industry leader with broad experience in finance, business development and operations. She joined Prokarium in 2018, most recently serving as Chief Operating Officer, and has led Prokarium’s expanding development efforts in oncology while also securing an investment from The Wellcome Trust to fund the company’s lead vaccine program into clinical development. She follows Ted Fjällman, PhD, who will continue to support the company as a member of the Board of Directors.

"As Prokarium accelerates its drug development efforts within oncology, Kristen brings extensive financing and strategic leadership experience that will propel the company forward at this key moment," said Steve Chatfield, PhD, Chairman of Prokarium’s Board of Directors. "Kristen will be an invaluable asset to Prokarium, and I look forward to working closely with her to bring the next generation of immunotherapies to cancer patients."

"I am delighted to have the opportunity to lead Prokarium at such an exciting time as we advance into our next phase of growth," said Dr. Albright. "I look forward to working with our Board members and the leadership and scientific teams to progress our lead oncology candidate into the clinic and leverage the full potential of our pipeline’s unique therapeutic approach."

Prior to Prokarium, Dr. Albright was an investor at Osage University Partners, where she led several investments into life sciences companies. Earlier in her career, she worked within business development at Emergent BioSolutions and Cangene Corporation, where she specialized in asset licensing and mergers and acquisitions. She started her industry career as a Post-Doctoral Fellow at Centocor. Dr. Albright holds an MBA from Saint Joseph’s University and earned her Doctor of Pharmacy from the Philadelphia College of Pharmacy at the University of the Sciences in Philadelphia.

On July 27, 2021 Nektar Therapeutics (Nasdaq: NKTR) reported that it will announce its financial results for the second quarter 2021 on Thursday, August 5, 2021, after the close of U.S.-based financial markets. Howard Robin, President and Chief Executive Officer, will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time (Press release, Nektar Therapeutics, JUL 27, 2021, View Source [SID1234585250]).

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The press release and live audio-only webcast of the conference call can be accessed through a link that is posted on the Home Page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through September 5, 2021.