On May 12, 2021 Recursion Pharmaceuticals, Inc. (Nasdaq : RXRX), a clinical-stage biotechnology company decoding biology by integrating technological innovations across biology, chemistry, automation, data science, and engineering, reported financial results for the first quarter of 2021 and provided business updates (Press release, Recursion Pharmaceuticals, MAY 12, 2021, View Source [SID1234579800]).

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"We are thrilled to have led Recursion through a successful IPO process which garnered support from new and existing healthcare and technology investors and better capitalized the company’s mission of decoding biology to radically improve lives," said Recursion Co-Founder and CEO Chris Gibson Ph.D. He continued, "We are excited about Recursion’s continued foray into inferential search, how that approach has quickly added many new programs to our portfolio in a short time, and how our new supercomputer, BioHive-1, will enable faster training and iteration of our machine learning algorithms and the ability to train on the totality of our nearly 8 petabytes of relatable biological data. And finally, we continue to make strides expanding, advancing, and executing on our pipeline of potential new medicines, including our four clinical stage programs and our first new chemical entity now headed towards clinical development."

Recursion finished the first quarter of 2021 with a portfolio of 4 clinical stage programs, 4 preclinical programs, 4 late discovery programs, and 25 early discovery programs, for a total of 37 research and development programs. Additionally, Recursion continued scaling the total number of executed phenomic experiments to over 67 million, the size of its total dataset to nearly 8 petabytes, and the number of biological inferences to over 92 billion. We accomplished this by utilizing a cellular library of 36 cell types, an in-house chemical library of over 706 thousand compounds, an in silico library of over 12 billion chemical scaffolds, and a growing team of more than 200 Recursionauts that is balanced between life scientists and computational and technical experts.

Summary of Business Highlights

Clinical Programs
Familial adenomatous polyposis (REC-4881) : We plan to initiate a Phase 2, randomized, double-blind, placebo-controlled study to evaluate efficacy and safety of REC-4881 in classical FAP patients within the next 4 to 5 quarters.
GM2 gangliosidosis (REC-3599) : We are generating additional pharmacodynamic data in an animal model of GM2 in anticipation of enrolling the first patient in an open-label Phase 2 trial in the next 4 to 5 quarters.
Neurofibromatosis type 2 (REC-2282) : The protocol has been updated based on scientific advice from the MHRA and FDA feedback from the special protocol assessment (SPA). We expect to enroll the first patient in an adaptive Phase 2/3, randomized, multicenter study within the next 4 to 5 quarters.
Cerebral cavernous malformation (REC-994) : We finalized the Phase 2 protocol and submitted it to the FDA. Subject to completion of all required CMC steps, we expect to enroll the first patient in a Phase 2, double-blind, placebo-controlled, safety, tolerability and exploratory efficacy study within the next 4 to 5 quarters.
Notable Preclinical Programs
Clostridium difficile colitis (REC-163964, REC-164014, REC-164067) : We completed exploratory, non-clinical, safety studies with three lead molecules to enable selection of a development candidate.
Immune checkpoint resistance in STK11-mutant NSCLC : We completed dose-optimization studies of REC-64151 that supported efficacy in rodent models at exposures achievable in humans.
Notable Late Discovery Programs
Neuroinflammation : This program is currently in the lead-optimization phase. The project has made progress in optimization of potency and pharmacokinetics of molecules in our lead series.
Batten disease : The program is currently in the lead-optimization phase. The project has made progress in optimization of potency and pharmacokinetics of molecules in our lead series.
Charcot-Marie-Tooth type 2A : The chemistry strategy has been constructed and relevant biochemical and cellular orthogonal assays are being developed.
Oncology – small molecule MYC Inhibitors : We have now confirmed that several molecules from multiple series exhibit activity in a c-Myc protein turnover assay and made progress in elucidating mechanisms underlying modulation of c-Myc degradation.
Partnership : There has been continued progress in our collaboration with Bayer to discover small molecule drug candidates targeting novel biology for the treatment of fibrotic diseases. Bayer’s library of approximately 500,000 compounds has been onboarded to Recursion and high throughput discovery screens have been initiated for two of the approximately 10 programs.
Inferential Search : In less than 9 months, Recursion’s transition to inferential search, which leverages its massive dataset for drug discovery, has yielded 18 programs in the area of oncology. This work has been led by Ron Alfa M.D., Ph.D., as Senior Vice President of Translational Medicine at Recursion. As a result of this success, Recursion is expanding its inferential search capabilities into neuroscience as well as inflammation and immunology.
Platform
Orthogonomics : We have made meaningful progress in both transcriptomics and proteomics at Recursion. Our transcriptomics team has standardized our protocol for extracting transcriptomic signals from experiments. Our proteomics team has been optimizing its ability to survey thousands of proteins to identify biomarkers with significant changes in level due to perturbation treatments. These technologies are now being applied to over a dozen early and late discovery programs at Recursion to quickly provide target-agnostic orthogonal validation data.
Digital Chemistry : We launched our digital chemistry-based target prediction tool which identifies potential targets for small molecules by comparing their structural fingerprints to well-annotated small molecules. This tool augments our mechanism of action deconvolution by taking chemical structure into account.
BioHive-1 : The company purchased, built, and activated BioHive-1, a purpose-built supercomputer that we believe is the 58th most powerful in the world and the most powerful supercomputer dedicated wholly to drug discovery for a single company.
Facilities : We initiated two facility expansions in Salt Lake City. First, we are expanding our current headquarters to add laboratory space that will support our plans for additional technology and future partnerships. Second, we are establishing a nearby CMC site for work in process chemistry, analytical chemistry, and drug substance production.
First Quarter 2021 Financial Results

Cash Position : Cash, cash equivalents and marketable securities were $214.1 million as of March 31, 2021 and do not include net proceeds from the company’s April 2021 IPO of $462.6 million.
Revenue : Total revenue, consisting primarily of revenue from collaborative agreements, was $2.6 million for the first quarter of 2021, compared to $60 thousand for the first quarter of 2020. The increase was primarily due to progress in our collaboration agreement with Bayer.
Research and Development Expenses : Research and development expenses were $24.1 million for the first quarter of 2021, compared to $12.8 million for the first quarter of 2020. The increase in research and development expenses over this period was primarily due to an increased number of experiments screened on the platform, an increased number of preclinical assets being validated, and the development of clinical-stage assets.
General and Administrative Expenses : General and administrative expenses were $8.9 million for the first quarter of 2021, compared to $5.6 million for the first quarter of 2020. The increase in general and administrative expenses was due to growth in size of the company’s operations including an increase in salaries and wages of $1.2 million, human resources costs, facilities costs, finance costs and other administrative costs associated with operating a growth-stage company.
Net Loss : Net loss was $30.7 million for the first quarter of 2021, compared to a net loss of $18.4 million for the first quarter of 2020.
Other Corporate Updates

IPO : Recursion upsized and completed its initial public offering in April 2021, raising gross and net proceeds of $501.8 million and $462.6 million, respectively.
Company Management : Since the end of 2020, Recursion has made several executive and board appointments aimed at further supporting the advancement of its pipeline and expanding its business operations. These appointments include naming R. Martin Chavez, Ph.D. as Chairman of our Board of Directors, Ramona Doyle, M.D. as Chief Medical Officer, and Louisa Daniels, J.D. as Chief Legal Officer and General Counsel. Additionally, Ron Alfa M.D., Ph.D. has been promoted to Senior Vice President of Research to lead the rapid creation and advancement of new early discovery programs based on our inferential search platform, and Sharath Hegde Ph.D. has resigned from his role as the company’s Chief Scientific Officer. Dr. Alfa will assume the responsibilities of Dr. Hegde. We thank Dr. Hegde for his substantial contributions to Recursion, which include accelerating our work with new chemical entities and curating our rapid repurposing library.

On May 12, 2021 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that interim data from the ongoing Phase 1/2 clinical trial investigating the safety and efficacy of MB-106 CD20-targeted CAR T for high-risk B-cell non-Hodgkin lymphomas ("B-NHL") and chronic lymphocytic leukemia ("CLL") has been selected for an e-poster presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) 2021 Virtual Congress ("EHA2021") (Press release, Mustang Bio, MAY 12, 2021, View Source [SID1234579818]). MB-106 is being developed in a collaboration between Mustang and Fred Hutchinson Cancer Research Center ("Fred Hutch").

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In the abstract posted today on the EHA (Free EHA Whitepaper)2021 website, Fred Hutch reported on 12 patients treated with MB-106, which underwent a major cell manufacturing modification after treating the first 7 patients as previously reported at the 62nd Annual American Society of Hematology (ASH) (Free ASH Whitepaper) meeting in 2020. The 12 patients treated under the new manufacturing process were treated at dose levels ("DL") ranging from 3.3×105 to 1×107 CAR T cells/kg, and clinical responses were observed at all DLs with no dose-limiting toxicities. Cytokine release syndrome occurred in 3 patients (25%): 2 patients with grade 1 and 1 patient with grade 2. Only 1 patient required tocilizumab and dexamethasone, and no immune effector cell-associated neurotoxicity syndrome of any grade was observed. Overall response rate ("ORR") was 92% (11/12) with a complete response ("CR") rate of 58% (7/12). In 9 patients with follicular lymphoma, ORR and CR were 89% (8/9) and 67% (6/9), respectively. The patient with CLL had a PET-negative CR and undetectable measurable residual disease in peripheral blood and bone marrow by flow cytometry (10-4) (uMRD4) on day 28. Among patients who received the highest two dose levels, DL3 (3.3×106 CAR T cells/kg; n=4) and DL4 (1×107 CAR T cells/kg; n=1), CR rate was 100% (5/5). All 7 patients who achieved a CR remain in remission at a median follow-up of 4 months. CAR T expansion was robust, with median peak blood levels of CAR+ T cells of 122 CAR+ cells/μl (range 0.27-2024), corresponding to 19% (range 0.15 – 65%) of all CD3+ cells. Updated data will be presented at EHA (Free EHA Whitepaper)2021.

Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "We are pleased that Fred Hutch will present interim data from the ongoing Phase 1/2 trial of MB-106 at EHA (Free EHA Whitepaper)2021. The data thus far indicate that MB-106 has a highly favorable safety profile at all dose levels when compared to commercially available CAR T cell therapies targeting CD19. We look forward to the continued progression of this CD20-targeted CAR T cell therapy program for patients with relapsed or refractory B-cell non-Hodgkin lymphomas and CLL."

Details of the MB-106 e-poster presentation are as follows:

Topic: 25. Gene therapy, cellular immunotherapy and vaccination – Clinical
Abstract Code: EP731
Title: Immunotherapy Using a 3rd Generation CD20 Targeted CAR T-Cell (MB-106) for Treatment of B-Cell Non-Hodgkin Lymphoma (B-NHL) and Chronic Lymphocytic Leukemia (CLL)
Presenter: Mazyar Shadman, M.D., M.P.H., Fred Hutchinson Cancer Research Center, Seattle, WA, USA
Date and Time: All e-posters will be available for viewing on June 11, 2021 at 09:00 Central European Summer Time (CEST) / 3 a.m. ET

A copy of the abstract can be viewed online through the EHA (Free EHA Whitepaper)2021 website at View Source

On May 12, 2021 Viracta Therapeutics, Inc. (Nasdaq: VIRX) (Viracta or the Company), a precision oncology company targeting virus-associated malignancies, reported financial results for the first quarter of 2021 and provided a clinical and corporate update (Press release, Sunesis, MAY 12, 2021, View Source [SID1234579881]).

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"Viracta has emerged from our first quarter as a publicly traded company well-positioned to make a significant impact on patients and create meaningful value for our shareholders. We are on track to initiate our pivotal NAVAL-1 trial as planned this quarter for the treatment of EBV-associated lymphoma, and we look forward to expanding into our second global clinical program in EBV-associated solid tumors in the second half of 2021," said Ivor Royston, M.D., President and Chief Executive Officer of Viracta.

Dr. Royston continued, "Today, we are excited to provide additional details of the NAVAL-1 trial design, which has been reviewed by the United States Food and Drug Administration. We believe the innovative and adaptive design of this registration-enabling pivotal trial will allow us to simultaneously progress towards potential NDA filings in multiple lymphoma subtypes."

First Quarter 2021 and Recent Highlights

Clinical

Announced design of NAVAL-1, a global pivotal trial in Epstein-Barr virus (EBV)-positive relapsed/refractory (R/R) lymphoma. NAVAL-1 (Nanatinostat in Combination with Valganciclovir) is a multinational, multicenter, open-label Phase 2 basket trial. The trial, which will include multiple subtype-specific cohorts of R/R EBV-positive lymphoma patients, is designed to evaluate the anti-tumor activity of the combination treatment of nanatinostat with valganciclovir and is anticipated to enroll up to 140 patients. The primary endpoint of the trial is objective tumor response rate as assessed by an independent review committee. If successful, Viracta believes this trial could support multiple NDA filings across various EBV-positive lymphoma subtypes. Viracta remains on track to initiate NAVAL-1 in Q2 2021.
Completed enrollment in Phase 2 expansion cohort of its Phase 1b/2 R/R EBV-positive lymphoma trial, with updated data expected in H2 2021. VT3996-201, Viracta’s Phase 1b/2 open-label, dose escalation/expansion trial of nanatinostat-valganciclovir combination treatment in R/R EBV-positive lymphoma has generated promising efficacy and safety data to date, as presented at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2020, including preliminary objective response and complete response rates (ORR/CR) of 80%/40% (n=10) and 67%/33% (n=6) in T/NK cell non-Hodgkin’s lymphoma and diffuse large B-cell lymphoma, respectively. The median duration of response was 10.4 months.
Corporate

Closed merger with Sunesis Pharmaceuticals, Inc. Shares of the combined company, Viracta Therapeutics, Inc., commenced trading on the Nasdaq Global Select Market under the ticker symbol "VIRX" on February 25, 2021.
Completed a $65 million private placement. On February 24, 2021, Viracta closed a private financing featuring a premier investor syndicate of biotechnology-focused and institutional accredited investors.
Strengthened balance sheet through a multi-license milestone and royalty monetization transaction with XOMA. In March 2021, Viracta announced that XOMA had purchased the potential future milestones and royalties associated with existing licenses relating to two clinical-stage drug candidates that Viracta obtained in the merger in exchange for an upfront payment of $13.5 million and up to $20 million in a pre-commercialization, event-based milestone. In the merger, Viracta also obtained exclusive and global rights to assets previously held by Sunesis including SNS-510, a PDK-1 inhibitor, and vecabrutinib, a BTK inhibitor. Viracta is evaluating future development and collaboration opportunities for SNS-510 and potential partnering opportunities for vecabrutinib.
Extended intellectual property protection around lead lymphoma program. In March 2021, the U.S. Patent and Trademark Office (USPTO) granted patent 10,953,011, which covers the anticipated dose regimen to be advanced in the NAVAL-1 trial. The patent provides Viracta with intellectual property protection into at least 2040.
Strengthened company leadership with new appointments to the Board of Directors and management team. Throughout the first quarter, Viracta appointed the following life sciences industry veterans to the Board of Directors: Stephen Rubino, Ph.D., MBA, and Barry J. Simon, M.D., who were each appointed following the closing of the merger, Thomas Darcy, who was appointed in connection with the closing of the merger, and Nicole Onetto, M.D., who remained on the combined company’s Board of Directors following the merger. The Company also appointed Cheryl A. Madsen, RAC as Senior Vice President, Regulatory Affairs.
Anticipated 2021 Milestones

Initiation of NAVAL-1, a global Phase 2 pivotal trial for R/R EBV-positive lymphoma: Q2 2021
Clearance of IND for a Phase 1b/2 clinical trial in EBV-positive solid tumors: mid-2021
Initiation of a global Phase 1b/2 clinical trial in EBV-positive solid tumors: H2 2021
Updated data from Phase 1b/2 trial in R/R EBV-positive lymphoma (VT3996-201): H2 2021
First Quarter 2021 Financial Results

Cash Position – Cash and cash equivalents totaled approximately $129.2 million as of March 31, 2021. Viracta expects to end 2021 with greater than $100 million in cash and cash equivalents, which it expects will be sufficient to fund its operations into 2024.
Research and Development Expenses – Research and development expenses were $4.0 million for the quarter ending March 31, 2021, compared to $3.4 million for the same period in 2020. This increase was primarily due to costs incurred to support study initiation activities for NAVAL–1, in addition to an increase in headcount and non-cash share-based compensation.
General and Administrative Expenses – General and administrative expenses were $3.8 million for the quarter ending March 31, 2021, compared to $1.0 million for the same period in 2020. This increase was primarily due to non-recurring, merger-related costs of approximately $2.0 million incurred in the period, in addition to incremental costs associated with being a publicly traded company and non-cash share-based compensation.
Acquired in-process research and development – Non-recurring, non-cash operating expenses of $84.5 million associated with the write-off of in-process research and development acquired in the merger were recorded for the quarter ending March 31, 2021.
Gain on Royalty Purchase Agreement – Gain on Royalty Purchase Agreement for the quarter ended March 31, 2021 was associated with upfront proceeds of $13.5 million received in connection with the multi-license milestone and royalty monetization transaction with XOMA Corporation in March 2021.
Adjusted income or loss from operations – Adjusted income from operations for the quarter ended March 31, 2021, excluding the non-recurring and non-cash operating expenses associated with the write-off of in-process research and development acquired in the merger (a non-GAAP measure) was $5.6 million, compared to an unadjusted loss from operations of $78.8 million. There is not a comparative adjustment to loss from operations for the same period in 2020.
Net loss – Net loss was $79.2 million, or $5.22 per share (basic and diluted) for quarter ended March 31, 2021, compared to $4.4 million, or $1.86 per share (basic and diluted), for the same period in 2020.
Key Opinion Leader Webinar

The design of NAVAL-1, a global pivotal trial in EBV-positive R/R lymphoma, will be discussed during a Key Opinion Leader webinar on May 20, 2021 at 2pm EST. The webinar will feature presentations by Pierluigi Porcu, M.D. (Thomas Jefferson University) and Kristen Cunanan, Ph.D. (Stanford University School of Medicine), who will discuss the current treatment landscape, unmet medical need in EBV-associated lymphoma and the trial design of NAVAL-1. The formal presentations will then be followed by a Q&A session with Drs. Porcu and Cunanan, accompanied by Company management. A link to register for the webcast is here: View Source

About NAVAL-1

NAVAL-1 (Nanatinostat in Combination with Valganciclovir) is a registration-enabling multinational, multicenter, open-label Phase 2 basket trial. The trial will include multiple subtype-specific with various EBV-positive relapsed/refractory lymphoma and is anticipated to enroll up to 140 patients. The primary endpoint of the trial is objective tumor response rate, while secondary endpoints include duration of response, survival outcomes, and the safety profile of the combined treatment. Trial eligibility includes patients with EBV-positive R/R lymphoma following two or more prior systemic therapies with no available standard therapies. For ENKTL patients only, eligibility includes patients with R/R disease following one or more prior systemic therapies with no available standard therapies who have failed an asparaginase-containing regimen.

On May 12, 2021 The Bayer Group reported that had a successful start to 2021 (Press release, Bayer, MAY 12, 2021, View Source [SID1234579768]). "We’re seeing a good operational performance overall, but we were impacted by negative currency effects as expected," said CEO Werner Baumann when the quarterly statement for the first quarter of 2021 was published on Wednesday . "Our Crop Science Division achieved encouraging sales growth in an improved market environment. Sales at Pharmaceuticals were steady, and in the Consumer Health Division we performed better than the competition." The company confirmed the full-year outlook it issued in February 2021.

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Group sales in the first quarter rose by 2.8 percent on a currency- and portfolio-adjusted basis (Fx & portfolio adj.) to 12.328 billion euros. EBITDA before special items fell by 6.2 percent to 4.118 billion euros. Negative currency effects impacted sales by 938 million euros and EBITDA before special items by 337 million euros. EBIT increased by 23.4 percent to 3.083 billion euros. This included net special gains of 15 million euros (Q1 2020: net special charges of 639 million euros), with income from a patent dispute related to the blood-clotting medicine Jivi more than offsetting the expenses for the ongoing restructuring program. Net income rose by 40.3 percent to 2.089 billion euros. Core earnings per share from continuing operations fell by 3.0 percent to 2.59 euros.

Free cash flow came in at minus 3.226 billion euros (Q1 2020: minus 793 million euros), the decline being mainly due to the settlement payments for litigations in the United States. This was also partly the reason for the 13.0 percent increase in net financial debt against the end of 2020, to 33.933 billion euros as of March 31, 2021.

Growth at Crop Science, especially in Latin America and Asia/Pacific

Bayer lifted sales in its agricultural business (Crop Science) by 6.4 percent (Fx & portfolio adj.) to 6.646 billion euros, with particularly strong growth in the Latin America and Asia/Pacific regions. Sales at Herbicides advanced by a significant 13.3 percent – mainly as a result of volume gains in all regions and higher prices, especially for Roundup. Business also improved substantially at Fungicides (plus 22.0 percent) and Vegetable Seeds (plus 13.9 percent). The Fungicides business benefited from volume and price increases in the Latin America region, particularly for the product Fox Xpro. This business also expanded in Asia/Pacific as the market situation normalized following the previous year’s restrictions related to the COVID-19 pandemic. Sales at Vegetable Seeds rose in all regions. The 3.4 percent (Fx & portfolio adj.) increase in sales at Soybean Seed & Traits was driven by volume gains in North America. Sales at Corn Seed & Traits remained at the level of the prior-year quarter (Fx & portfolio adj. minus 0.4 percent). This business developed positively in the Europe/Middle East/Africa region and in Latin America, partly as a result of higher prices, whereas it shrank in North America, in part due to a license expiration.

EBITDA before special items at Crop Science decreased by 6.2 percent to 2.448 billion euros, giving a margin of 36.8 percent. Positive effects from price and volume increases and the contributions from the ongoing efficiency programs did not fully offset the negative currency effects of 252 million euros.

As regards the litigation involving glyphosate-based Roundup products in the United States, approximately 96,000 current claims overall are covered by settlement agreements, or did not meet the settlement program eligibility criteria. The company continues to negotiate with plaintiffs’ counsel to reach agreements in the remainder of current cases. A new proposal for the management of future cases agreed upon with and supported by plaintiffs’ class counsel has been submitted to the responsible judge in California for preliminary approval. For the revised proposal, both parties worked diligently to address the points mentioned by the court.

Pharmaceuticals: significant advances for Xarelto and Eylea

Sales of prescription-only medicines (Pharmaceuticals) came in at 4.365 billion euros and were thus level with the prior-year period on a currency- and portfolio-adjusted basis (Fx & portfolio adj. minus 0.4 percent). In China, sales declines for Glucobay and Avelox as a result of the tender procedures implemented in 2020 were offset by growth in other products, especially the oral anticoagulant Xarelto. In the United States, the division benefited particularly from the launch of the cancer drug Nubeqa.

Bayer raised sales of Xarelto by 6.5 percent (Fx & portfolio adj.). This was mainly due to expanded volumes in China and Russia, while business in Germany declined substantially. A considerable increase of 15.8 percent (Fx & portfolio adj.) in sales of the ophthalmology drug Eylea was driven by positive development in Japan and markedly higher volumes in Europe, China and Canada. The business with the oral contraceptives YAZ/Yasmin/Yasminelle grew by 12.3 percent (Fx & portfolio adj.), with increases especially in China, Japan and the Middle East. However, there was a distinct drop in sales of the Kogenate/Kovaltry/Jivi blood-clotting medicines (Fx & portfolio adj. minus 17.9 percent) and the cancer drug Nexavar (Fx & portfolio adj. minus 21.7 percent) due to competition.

EBITDA before special items at Pharmaceuticals declined by 6.0 percent to 1.498 billion euros, yielding a margin of 34.3 percent. Earnings were diminished by price declines in sales along with negative currency effects of 57 million euros, which were offset to some extent by volume gains and cost reductions. There was also a positive effect on research and development expenses that came partly from the proportionate recognition of proceeds from the sale of a priority review voucher in the United States.
 
Consumer Health: performance ahead of competition cycling over exceptionally strong prior-year quarter

Following an exceptionally strong prior-year quarter with double-digit percentage growth, sales of self-care products (Consumer Health) registered a 4.4 percent decrease (Fx & portfolio adj.) to 1.252 billion euros in a declining market. The performance remained ahead of competition with growth momentum in the Dermatology and Nutritionals categories, with business up by 6.6 percent and 4.7 percent, respectively (Fx & portfolio adj.). However, the continuing high level of protective and hygiene measures and the ongoing lockdowns had a negative impact on sales, particularly on cough and cold products. This led to a decline of 30.1 percent (Fx & portfolio adj.) in the Allergy & Cold category. While sales in Asia/Pacific and Latin America showed continued positive growth, sales in North America and Europe/Middle East/Africa were markedly affected by the extraordinarily mild cough and cold season.

EBITDA before special items at Consumer Health moved back 3.0 percent to 292 million euros. Earnings were diminished by negative currency effects of 26 million euros. At the same time, the EBITDA margin before special items improved by 1.8 percentage points to 23.3 percent, largely on account of lower marketing expenses in the currently volatile market environment as well as one-time gains from the divestment of three non-core brands.

Sustainability efforts further enhanced

Bayer also made good progress in the area of sustainability in the first quarter. As already announced in February, the company is stepping up its efforts to achieve an even more inclusive and diverse workforce and corporate culture, targeting gender parity on all management levels for the year 2030. Also in February, the Consumer Health Division, for example, launched its Nutrient Gap Initiative to help close the gap in the supply of vitamins and minerals to people in underserved regions. The program aims to reach 50 million people annually in these regions by 2030 through direct action and in partnership with major NGOs. The Nutrient Gap Initiative will contribute to the attainment of the Consumer Health Division’s sustainability goal of providing 100 million people in underserved communities with access to everyday health care by 2030.

On May 12, 2021 Incyte (Nasdaq:INCY) reported that multiple abstracts highlighting data from its oncology portfolio will be presented during the upcoming European Hematology Association (EHA) (Free EHA Whitepaper) 2021 Virtual Congress, held virtually from June 9-17, 2021 (Press release, Incyte, MAY 12, 2021, View Source [SID1234579785]).

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"We are pleased that data highlighting the strength of Incyte’s oncology portfolio and partner-sponsored programs will be presented at this year’s EHA (Free EHA Whitepaper) Virtual Congress," said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapeutics, Incyte. "In particular, data being presented at the congress – including the first presentation of data from our Phase 2 study of parsaclisib, our PI3kδ inhibitor, in autoimmune hemolytic anemia; an oral presentation on real-world data for ruxolitinib, our JAK1/JAK2 inhibitor; and an ePoster from our Phase 2 combination study of ruxolitinib and parsaclisib in patients with myelofibrosis – reinforce our commitment to finding solutions for patients with significant unmet medical needs."

Key abstracts accepted by EHA (Free EHA Whitepaper) include:

Oral Presentations

Ponatinib

OPTIC Primary Analysis: A Dose-Optimization Study of 3 Starting Doses of Ponatinib (PON)1(Abstract #S153. Session: Response, Resistance and Treatment-Free Remission in CML.)

Ruxolitinib

Efficacy and Safety of Ruxolitinib in Patients with Steroid-Refractory Acute Graft-Vs-Host Disease After Crossover in the Phase 3 REACH2 Study2(Abstract #S236. Session: Stem cell transplantation – GvHD.)

Impact of Ruxolitinib on Survival of Patients with Myelofibrosis in Real World – Update of ERNEST (European Registry for Myeloproliferative Neoplasms) Study2(Abstract #S158. Session: Population based studies in myeloid disorders.)

ePosters

Parsaclisib

Efficacy and Safety Results from an Open-Label Phase 2 Study of Parsaclisib for the Treatment of Autoimmune Hemolytic Anemia (AIHA) (Abstract #EP685. Session: Enzymopathies, Membranopathies and Other Anemias.)

Pharmacologic Inhibition of PI3kδ Reduces Autoantibody Formation and is Efficacious in a Preclinical Model of Autoimmune Hemolytic Anemia (Abstract #EP693. Session: Enzymopathies, Membranopathies and Other Anemias.)

FACIT-Fatigue Subscale Outcomes from an Ongoing Phase 2, Open-Label Study of the Phosphatidylinositol 3-Kinase Delta (PI3Kδ) Inhibitor Parsaclisib in Patients with Autoimmune Hemolytic Anemia (AIHA) (Abstract #EP706. Session: Enzymopathies, Membranopathies and Other Anemias.)

Ponatinib

French Real-Life Observational Study "TOPASE" Evaluating Safety and Efficacy of Ponatinib Confirms Induction of Deep Molecular Responses in 110 Resistant or Intolerant CML Patients (Abstract #EP679. Session: Chronic Myeloid Leukemia – Clinical.)

Ruxolitinib

An Epidemiological Study of the Cardiovascular Health and Thrombotic Risk Profiles of Patients with Myeloproliferative Neoplasms in Primary Care Across the United Kingdom2 (Abstract #EP1090. Session: Myeloproliferative Neoplasms – Clinical.)

Impact of Bone Marrow Fibrosis Grade on Response and Outcome in Patients with Primary Myelofibrosis Treated with Ruxolitinib: A Post-Hoc Analysis of the JUMP Study2 (Abstract #EP1092. Session: Myeloproliferative Neoplasms – Clinical.)

Healthcare Resource Utilization in Patients with Myeloproliferative Neoplasms: A Nationwide Matched Cohort Study2 (Abstract #EP1107. Session: Myeloproliferative Neoplasms – Clinical.)

Ruxolitinib-Parsaclisib Combination Studies

Add-On Parsaclisib (a PI3kδ inhibitor) in Patients with Myelofibrosis and Suboptimal Response to Ruxolitinib: Interim Analysis from a Phase 2 Study (Abstract #EP1075. Session: Myeloproliferative Neoplasms – Clinical.)

Tafasitamab

Estimation of Long-Term Survival with Tafasitamab + Lenalidomide in Relapsed/Refractory Diffuse Large B-Cell Lymphoma3(Abstract #EP553. Session: Aggressive Non-Hodgkin Lymphoma – Clinical.)

First-MIND: A Phase 1b, Open-Label, Randomized Study to Assess Safety of Tafasitamab or Tafasitamab + Lenalidomide in Addition to R-CHOP in Patients with Newly Diagnosed DLBCL3(Abstract #EP496. Session: Aggressive Non-Hodgkin Lymphoma – Clinical.)

Lenalidomide-Induced Effects on Cell Surface Expression of CD19 and CD20 in DLBCL Cell Lines and Functional Impact on Antibody-Mediated Cytotoxicity3(Abstract #EP879 . Session: Lymphoma Biology & Translational Research.)

In addition to the presentations noted above, more than 10 publications highlighting data from Incyte’s portfolio will be made available by EHA (Free EHA Whitepaper) as publications. Notably, these publications include bioequivalence and bioavailability data for ruxolitinib’s once-daily extended release (XR) formulation – Bioequivalence of 50 mg Once-Daily Ruxolitinib Extended Release (XR) Tablets Compared to 25 mg Twice-Daily Ruxolitinib Immediate Release (IR) Tablets (Abstract #PB1706) and Relative Bioavailability and Dose Linearity of Five Strengths of Ruxolitinib Extended Release (XR) Tablets (Abstract #PB1717).

Full listings for oral presentations and ePoster sessions are available on the EHA (Free EHA Whitepaper) website: View Source Oral, poster discussion and poster sessions, as well as track-based clinical science symposia, accepted for presentation at EHA (Free EHA Whitepaper) will be available on demand for registered attendees beginning Friday, June 11, 2021, through Sunday, August 15, 2021.