On August 11, 2021 Genmab reported that antibody expertise and innovation were on display during the second quarter of 2021 with the U.S. FDA’s acceptance for priority review of the BLA for tisotumab vedotin, which we are developing with Seagen, and with the approval of Janssen’s RYBREVANT (amivantamab-vmjw), the first regulatory approval for a product created using Genmab’s proprietary DuoBody technology platform (Press release, Genmab, AUG 11, 2021, View Source [SID1234586311]). The majority of Genmab’s clinical stage products are based on our DuoBody technology, and we hope that the approval of RYBREVANT is just the first validation of many of the potential for this technology to create effective treatments for patients with cancer," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

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Financial Performance First Half of 2021

Net sales of DARZALEX by Janssen Biotech, Inc. (Janssen) were USD 2,798 million in the first half of 2021 compared to USD 1,838 million in the first half of 2020, an increase of USD 960 million, or 52%.
Royalty revenue was DKK 2,595 million in the first half of 2021 compared to DKK 1,738 million in the first half of 2020, an increase of DKK 857 million, or 49%. The increase was driven by higher net sales of DARZALEX, TEPEZZA and Kesimpta resulting in higher royalties.
Total revenue for the first half of 2021 was DKK 3,553 million. In addition to the royalty revenue described above, Genmab also recognized DKK 731 million of milestone revenue during the first half of 2021. Revenue for the first half of 2020 was DKK 6,343 million and included the one-time upfront payment of DKK 4,398 million recognized as license revenue from AbbVie Inc. (AbbVie) pursuant to our collaboration announced in June 2020.
Operating expenses were DKK 2,234 million in the first half of 2021 compared to DKK 1,775 million in the first half of 2020. The increase of DKK 459 million, or 26%, was driven by the continued advancement of multiple pipeline projects, and the increase in new employees to support the expansion of our product pipeline and building our commercialization capabilities and broader organizational infrastructure.
Operating result was DKK 1,319 million in the first half of 2021 compared to DKK 4,568 million in the first half of 2020. The decrease of DKK 3,249 million, or 71%, was driven by lower revenue as a result of the non-recurring license revenue in 2020 and increased operating expenses.

Outlook
Genmab is improving its 2021 financial guidance published on February 23, 2021, driven primarily by increased royalty revenue related to the net sales of DARZALEX.

Genmab will hold a conference call to discuss the results for the first half of 2021 today, Wednesday, August 11, at 6:00 pm CEST, 5:00 pm BST or 12:00 pm EDT. To join the call dial
+1 631 913 1422 (U.S. participants) or +44 3333 000804 (international participants) and provide conference code 78377092.

A live and archived webcast of the call and relevant slides will be available at genmab.com/investors.

On August 11, 2021 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted therapies for rare and difficult to treat cancers, reported it will present data from one planned clinical trial and one completed preclinical study evaluating its lead investigational drug, Rhenium-186 Nanoliposome (186RNL), for the treatment of leptomeningeal metastases (LM) (Press release, Cytori Therapeutics, AUG 11, 2021, View Source [SID1234586310]). The data will be presented at the Third Annual Conference on Brain Metastases hosted by the Society for Neuro-Oncology (SNO), being held virtually August 19-20, 2021.

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Data from both studies will be presented as electronic posters (ePosters) by Andrew J. Brenner, M.D., Ph.D., Associate Professor of Medicine, Neurology, and Neurosurgery at The University of Texas, and principal investigator, and will be viewable to meeting attendees beginning at the start of the conference on Thursday, August 19 at 11:00 am EDT. The accepted abstracts are currently available in the Neuro-Oncology Advances Journal. Details of both are as follows:

LMD-13: "ReSPECT-LM: Maximum tolerated dose, safety, and efficacy of intraventricular Rhenium-186 Nanoliposome ( 186 RNL) for leptomeningeal metastases"
Data from the ongoing U.S. multi-center ReSPECT-GBM Phase 1 dose-finding clinical trial in adults with recurrent glioblastoma (NCT01906385) demonstrate that the mean absorbed dose of 186RNL to the tumor when coverage was 75% or greater (n=10) was 392 Gy (CI 306 – 478). Thus far, the therapy has been well tolerated with one possible treatment-related serious adverse event, cerebral edema, that resolved after steroid treatment.

In addition, this abstract details a proposed two-part clinical trial for patients with leptomeningeal metastases (LM). Part 1 will enroll up to 21 subjects to characterize the safety and tolerability of a single dose of 186RNL administered intraventricularly via an Ommaya reservoir and identify a maximum tolerated dose (MTD) / maximum feasible dose (MFD) for future studies, and Part 2 will independently evaluate 186RNL in two different cohorts. Cohort A will enroll up to 20 subjects with a diagnosis of LM from primary breast cancer. Cohort B will enroll up to 20 subjects with a diagnosis of LM from primary non-small cell lung cancer. The primary endpoint is to estimate the anti-tumor activity of 186RNL as a single agent. The full abstract can be found here: View Source

LMD-14: "Preclinical safety and activity of intraventricular Rhenium-186 Nanoliposome ( 186 RNL) for leptomeningeal metastases"
As part of this preclinical safety and activity study, researchers concluded that the intraventricular delivery of 186RNL is well tolerated and improves animal survival at two weeks in a rat model of LM. The full abstract can be found here: View Source

Copies of each poster will be made available under the Presentations tab of the Investors section of the Company’s website when presentations go live at www.plustherapeutics.com.

LM are a rare but typically fatal complication of advanced cancer that affects the fluid-lined structures of the central nervous system and are diagnosed in approximately five percent of patients with metastatic cancer. With survival measured in weeks to months, novel approaches are needed that can both improve quality and quantity of life. 186RNL permits the selective delivery of beta-emitting radiation of high specific activity directly to the tumor.

On August 11, 2021 Sorrento Therapeutics, Inc. (NASDAQ: SRNE; "Sorrento"), a clinical stage biopharmaceutical company developing new therapies to treat cancer, pain and COVID-19, and Dyadic International, Inc. (NASDAQ: DYAI; "Dyadic"), a global biotechnology company focused on further improving, applying and deploying its proprietary C1-cell protein production platform to accelerate development, lower production costs and improve access to biologic vaccines and drugs at flexible commercial scales, reported the signing of a binding term sheet to enter into an exclusive license agreement to develop and commercialize vaccines, therapeutics, and diagnostics for coronaviruses, including Dyadic’s lead COVID-19 vaccine candidate, DYAI-100, produced using Dyadic’s proprietary and patented C1-cell protein production platform (Press release, Sorrento Therapeutics, AUG 11, 2021, View Source [SID1234586308]). The final terms of the license will be set forth in a definitive agreement to be entered into between the parties.

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Sorrento Chairman and CEO, Dr. Henry Ji, commented, "We look forward to continuing our collaboration with Dyadic, which began last year, initially with a goal of developing and commercializing a protein-based COVID-19 vaccine that can be rapidly manufactured in large quantities in our existing cGMP facilities, and stored and transported at room temperature, in order to increase access and affordability to underserved populations globally." Dr Ji. continued, "Over the past six months we have carried out several promising preclinical animal studies using the C1-produced RBD antigen in Dyadic’s lead COVID-19 vaccine candidate, DYAI-100. Our goal is to manufacture a COVID-19 vaccine that will provide protection across the variants of concern, including Delta, and in addition, apply the C1 protein production platform broadly across our current and future coronavirus programs."

Mark Emalfarb, Dyadic’s President and Chief Executive Officer noted, "We are delighted to have executed a binding term sheet with Sorrento Therapeutics to license the C1 technology for the development and commercialization of coronavirus vaccines, therapeutics, and diagnostics, including COVID-19. This marks a significant milestone in our corporate development efforts as we expect the license agreement we will enter into to enable us to monetize our internal COVID-19 development efforts with a partner that has the resources and expertise to advance vaccines, therapeutics, and diagnostics both clinically and commercially."

"The license agreement, when executed, contemplates an up-front payment of $10 million in cash and stock, up to $4 million in reimbursements for preclinical and clinical development costs incurred by Dyadic for the development and advancement of our proprietary DYAI-100 vaccine, up to $33 million in milestone payments and ongoing royalties following commercialization. All future development costs related to this license will be incurred by Sorrento," concluded Mr. Emalfarb.

Mr. Michael Tarnok, Dyadic’s Board Chairman noted, "This is a significant event for Dyadic and humankind globally, having achieved our goal of creating a pathway that potentially addresses the COVID-19 vaccine production gap for mass scale immunizations and treatments across the globe, quickly and efficiently. The Sorrento license will cover all other territories not already covered by Dyadic’s existing COVID-19 agreements with Medytox, Syngene and the Rubic Consortium."

On August 11, 2021 RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in oncology and inflammatory diseases, reported financial results for the second quarter and six months ended June 30, 2021 (Press release, RAPT Therapeutics, AUG 11, 2021, https://investors.rapt.com/news-releases/news-release-details/rapt-therapeutics-reports-second-quarter-2021-financial-results [SID1234586288]).

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"The second quarter was filled with a number of important milestones," said Brian Wong, M.D., Ph.D., President and Chief Executive Officer of RAPT Therapeutics. "We were thrilled to announce positive topline results from our Phase 1b clinical trial of RPT193 in atopic dermatitis in June. Shortly thereafter, we closed an underwritten public offering with net proceeds to RAPT of $134.6 million, significantly bolstering our cash position. Having demonstrated early proof-of-concept of our two lead drug candidates, RPT193 and FLX475, in atopic dermatitis and cancer, respectively, we are well positioned to advance our product development efforts and look forward to reporting additional data as these programs progress."

Financial Results for the Second Quarter Ended June 30, 2021

Second Quarter ended June 30, 2021

Net loss for the second quarter of 2021 was $16.1 million, compared to $12.4 million for the second quarter of 2020.

Research and development expenses for the second quarter of 2021 were $13.2 million, compared to $11.0 million for the same period in 2020. This increase was primarily due to increased clinical trial costs for FLX475 and increases in expenses for preclinical programs, laboratory supplies, stock-based compensation and facilities, offset by a decrease in clinical trial costs for RPT193.

General and administrative expenses for the second quarter of 2021 were $3.8 million, compared to $2.8 million for the same period of 2020. The increase was primarily due to increases in stock-based compensation expense, insurance expense and personnel costs.

Six Months Ended June 30, 2021

Net loss for the six months ended June 30, 2021 was $32.6 million, compared to $25.5 million for the same period in 2020.

Research and development expenses for the six months ended June 30, 2021 were $27.0 million, compared to $21.7 million for the same period in 2020. The increase was primarily due to increases in costs relating to the clinical trials of FLX475 and RPT193, as well as increases in stock-based compensation, personnel expenses, facilities costs and laboratory supplies spend.

General and administrative expenses for the six months ended June 30, 2021 were $7.8 million, compared to $6.1 million for the same period of 2020. The increase in general and administrative expenses was primarily due to increased stock-based compensation expense and personnel costs.

As of June 30, 2021, the Company had cash and cash equivalents and marketable securities of $223.3 million, which includes net proceeds of approximately $134.6 million from our recent public offering of 4,356,060 shares of common stock.

On August 11, 2021 Cytocom, Inc. (NASDAQ: CBLI), a leading biopharmaceutical company creating next-generation immune therapies that focus on immune restoration and homeostasis, reported that the company will participate at the Empowering the Kingdom through Business Conference hosted by the Liberty University School of Business on August 10-12, 2021 (Press release, Cytocom, AUG 11, 2021, https://www.cytocom.com/2021/08/11/cytocom-inc-announces-participation-at-liberty-universitys-empowering-the-kingdom-through-business-conference/?utm_source=rss&utm_medium=rss&utm_campaign=cytocom-inc-announces-participation-at-liberty-universitys-empowering-the-kingdom-through-business-conference [SID1234586287]). Cytocom President and CEO, Mike K. Handley, will participate live as a featured panelist in the Healthcare Breakout session moderated by Dean Joseph Johnson on August 11, 2021.

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