On May 6, 2021 CRISPR Therapeutics (NASDAQ: CRSP), a biopharmaceutical company focused on developing transformative gene-based medicines for serious diseases, and Nkarta, Inc. (NASDAQ: NKTX), a biopharmaceutical company developing engineered NK cell therapies to treat cancer, reported a strategic partnership to research, develop, and commercialize CRISPR/Cas9 gene-edited cell therapies for cancer (Press release, Nkarta, MAY 6, 2021, View Source [SID1234579318]).

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Under the agreement, the companies will co-develop and co-commercialize two CAR NK cell product candidates, one targeting the CD70 tumor antigen and the other target to be determined. In addition, the companies will bring together their complementary cell therapy engineering and manufacturing capabilities to advance the development of a novel NK+T product candidate harnessing the synergies of the adaptive and innate immune systems. Finally, Nkarta obtains a license to CRISPR gene editing technology to edit five gene targets in an unlimited number of its own NK cell therapy products.

CRISPR Therapeutics and Nkarta will equally share all research and development costs and profits worldwide related to the collaboration products. For each non-collaboration product candidate incorporating a gene editing target licensed from CRISPR Therapeutics, Nkarta will retain worldwide rights and pay CRISPR Therapeutics milestones and royalties on net sales. The agreement includes a three-year exclusivity period between CRISPR Therapeutics and Nkarta covering the research, development, and commercialization of allogeneic, gene-edited, donor-derived NK cells and NK+T cells.

"By bringing together CRISPR Therapeutics’ and Nkarta’s highly complementary expertise and proprietary platforms we plan to accelerate the development of potentially groundbreaking genome engineered NK cell therapies," said Samarth Kulkarni, Ph.D., Chief Executive Officer at CRISPR Therapeutics. "This collaboration broadens the scope of our efforts in oncology cell therapy, and expands our efforts to discover and develop novel cancer therapies for patients."

"Uniting the best-in-class gene editing solution and allogeneic T cell therapy expertise of CRISPR with Nkarta’s best-in-class CAR NK cell therapy platform will be a major advantage to advancing the next wave of transformative cancer cell therapies," said Paul J. Hastings, President and Chief Executive Officer of Nkarta. "With this partnership, Nkarta can systematically apply world-class gene editing across our entire pre-clinical pipeline going forward. CRISPR’s deep understanding of CD70 biology and experience in allogeneic T cell clinical development can accelerate the development of early-stage Nkarta programs, to deliver innovative treatments to patients that much faster."

Nkarta Conference Call Details

Nkarta management will host a conference call to discuss the collaboration today at 4:30 p.m. Eastern Time (ET). The event will be simultaneously webcast and available for replay from the Nkarta website at www.nkartatx.com, under the Investors section. Investors may also participate in the conference call by calling 877-876-9174 (domestic) or +1-785-424-1669 (international). The conference ID is NKARTA.

On May 6, 2021 Rice Powell, Chief Executive Officer of Fresenius Medical Care, reported: "The COVID-19 pandemic continues to plague our societies and especially our vulnerable patients (Press release, Fresenius, MAY 6, 2021, View Source [SID1234579317]). We are very grateful that we are increasingly allowed to directly vaccinate our dialysis patients in our clinics. By doing so, we can support healthcare systems, contribute to saving lives and overcoming this health crisis as fast as possible. While we have seen significant progress in the roll-out and adoption of vaccinations globally, COVID-19 infection rates in several countries remain high. This will, unfortunately, continue to affect many of our patients. Consequently, this will also continue to impact our organic growth and weigh on our earnings development throughout the year. As the underlying development in the first three months was in line with our expectations, we confirm our guidance for the full year 2021."

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1 Net income attributable to shareholders of Fresenius Medical Care AG & Co. KGaA

COVID-19 impact on organic growth continues to accumulate as expected

The adverse COVID-19 impact on organic growth in the Health Care Services business amounted to around 350 basis points in the first quarter. While monthly excess mortality continuously declined since February, it is expected to further accumulate and peak in the second quarter.

Besides Fresenius Medical Care’s comprehensive measures to reduce infection risks and maintain safe operations in its dialysis centers, vaccinations are crucial for containing the COVID-19 pandemic. In several countries, Fresenius Medical Care has made its dialysis clinics available for the direct vaccination of patients and, where requested, the general public. At the end of March, the U.S. government agreed to directly allocate COVID-19 vaccine to dialysis centers nationwide. At Fresenius Medical Care’s U.S. facilities, more than 64% of patients and 47% of dialysis center staff have been at least partially vaccinated. The Company is making further progress every day. On a global basis, about 51 percent of Fresenius Medical Care’s patients have received at least one vaccination.

Outlook

Fresenius Medical Care confirms its outlook for FY 2021 as outlined on February 23, 2021. The Company expects revenue to grow at a low- to mid-single digit percentage rate and net income to decline at a high-teens to mid-twenties percentage rate against the 2020 base.2

2 These targets are based on the 2020 results excluding the impairment of goodwill and trade names in the Latin America Segment of EUR 195 million. They are inclusive of anticipated COVID-19 effects, in constant currency and exclude special items. Special items include costs related to FME25 and other effects that are unusual in nature and have not been foreseeable or not foreseeable in size or impact at the time of giving guidance.

The Company continues to monitor closely the latest COVID-19-related developments in respect to additional variants of the virus and potential surges in different regions.

Fresenius Medical Care will experience an adverse earnings effect due to the U.S. government delaying the CKCC models (Comprehensive Kidney Care Contracting) by nine months to January 1, 2022. This effect will be offset by the further extension of the U.S. Medicare sequestration relief from April 1, 2021 until the end of 2021.

To support its 2025 strategy, further strengthen profitability and compensate for the negative earnings effects of the COVID-19 pandemic, Fresenius Medical Care has initiated the FME25 program. The Company is currently undergoing a detailed review of its global operating model and will provide an update in the second half of 2021.

Driving value-based care

Fresenius Medical Care aims to build sustainable partnerships with payors to support the transition from a fee-for-service to a pay-for-performance healthcare system. This applies equally to reimbursement models of commercial and public insurers. In the U.S., Fresenius Medical Care recently extended its value-based arrangement with Aetna, Inc., a provider of health insurance and related services and subsidiary of CVS Health Corporation, to include patients enrolled in Medicare Advantage. In late 2020, Fresenius Medical Care expanded its cooperation with health insurer Humana and thereby implemented the existing clinical network contract as a value-based payment model.

Revenue and earnings impacted by COVID-19 and exchange rate effects

Revenue declined by 6% to EUR 4,210 million (+1% at constant currency). Organic growth amounted to 1%.

Health Care Services revenue decreased by 7% to EUR 3,325 million (+1% at constant currency, +1% organic). The decline was mainly due to a negative exchange rate effect, the absence of a prior-year partial reversal of a revenue recognition adjustment, the impact from COVID-19 and lower reimbursement for calcimimetics.

Health Care Products revenue declined by 1% to EUR 885 million (+4% at constant currency, +5% organic). Headwinds from exchange rates and lower sales of acute care products as well as in-center disposables were partially offset by higher sales of machines for chronic treatment, peritoneal dialysis products and home hemodialysis products.

Operating income decreased by 15% to EUR 474 million (-8% at constant currency), resulting in a margin of 11.3% (Q1 2020: 12.4%). The decrease was mainly driven by effects from COVID-19 across all regions, higher personnel expenses and a significant negative exchange rate effect. In addition, operating income was negatively affected by a positive prior-year effect from the divestiture of cardiovascular clinics and a prior-year partial reversal of a revenue recognition adjustment. These negative effects were partially offset by an improved payor mix, mainly driven by Medicare Advantage, and expected lower SG&A expense, which are anticipated to reverse in the remainder of the year.

Net income1 declined by 12% to EUR 249 million (-6% at constant currency). Besides the above-mentioned operating earnings effects, net income was supported by a 27% decrease of net interest expense to EUR 76 million (Q1 2020: EUR 104 million).

The first quarter 2020 included negative COVID-19 effects that reversed in Q2 2020, including the compensation received under the CARES Act, and therewith increase the base for the second quarter 2021. These base effects impact the phasing of net income growth in 2021.

Basic earnings per share (EPS) decreased by 10% to EUR 0.85 (-4% at constant currency). The decline as a result of the above-mentioned earnings effects was partially offset by a decrease in the average weighted number of shares outstanding due to the redemption of shares following the completed share buyback program.

Cash flow development

Fresenius Medical Care generated EUR 208 million of operating cash flow (Q1 2020: EUR 584 million), resulting in a margin of 4.9% (Q1 2020: 13.0%). The decline was driven by the seasonality in invoicing and periodic delays in payment of public health care organizations.

Free cash flow3 amounted to EUR 29 million (Q1 2020: EUR 304 million), resulting in a margin of 0.7% (Q1 2020: 6.8%).

3 Net cash used in operating activities, after capital expenditures, before acquisitions, investments and dividends

Regional developments

In North America, revenue declined by 9% to EUR 2,899 million (-1% at constant currency, -1% organic). Besides a sizable negative exchange rate effect, this was mainly due to a substantial negative impact of COVID-19 on the Services business and lower reimbursement for calcimimetics.

Operating income in North America declined by 14% to EUR 399 million (-6% at constant currency), resulting in a margin of 13.7% (Q1 2020: 14.5%). The decrease was mainly due to the effects of COVID-19, higher personnel expense, headwinds from exchange rates, a positive prior-year effect from the divestiture of cardiovascular clinics, a prior-year partial reversal of a revenue recognition adjustment and a lower contribution from calcimimetics. This was mitigated by an improved payor mix, mainly driven by an increased Medicare Advantage share, contributions from acquisitions and lower SG&A expense due to favorable phasing.

Revenue in EMEA decreased by 1% and amounted to EUR 670 million (+1% at constant currency, +1% organic). This was mainly driven by the unfavorable effects of COVID-19 and negative exchange rate effects.

Operating income in the EMEA region declined by 21% to EUR 80 million (-21% at constant currency), resulting in a margin of 11.9% (Q1 2020: 14.9%). The prior-year base benefitted from the revaluation of an investment. In addition, the decline was mainly driven by an unfavorable country mix in the Products business, a decrease in dialysis days as well as higher cost for personnel and supplies in certain countries. This was partially offset by lower bad debt expense.

In Asia-Pacific, revenue increased by 6% to EUR 471 million (+10% at constant currency, +11% organic), mainly due to organic growth in the Services and Product businesses as well as contributions from acquisitions. This was partially offset by the effect of clinics closed or sold in the prior year.

Operating income grew by 11% to EUR 85 million (+14% at constant currency), resulting in a margin of 18.1% (Q1 2020: 17.3%). The prior-year base benefited from a gain from the deconsolidation of clinics. The increase was mainly driven by business growth and a favorable impact from manufacturing.

Including a very significant headwind from exchange rates and a negative effect from COVID-19, Latin America revenue decreased by 5% to EUR 159 million (+17% at constant currency, +15% organic). Operating income in Latin America declined by 3% to EUR 7 million (+3% at constant currency), resulting in a margin of 4.2% (Q1: 2020: 4.1%).

Patients, Clinics and Employees

As of March 31, 2021, Fresenius Medical Care treated 344,476 patients in 4,110 dialysis clinics worldwide. At the end of the first quarter, the Company had 124,995 employees (full-time equivalents) worldwide, compared to 121,403 employees as of March 31, 2020.

Conference call

Fresenius Medical Care will host a conference call to discuss the results of the first quarter of 2021 on May 6, 2021 at 3:30 p.m. CET / 9:30 a.m. ET. Details will be available on the company’s website www.freseniusmedicalcare.com in the "Investors" section. A replay will be available shortly after the call.

Please refer to our statement of earnings included in the PDF-file for a complete overview of the results of the first quarter of 2021. Our 6-K disclosure provides more details.

On May 6, 2021 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that the research collaboration by Chugai (Forerunner Pharma Research), Department of Allergy and Rheumatology at the University of Tokyo Hospital, and RIKEN on a functional genome database was published online in the U.S. scientific journal Cell on April 29, 2021 (Press release, Chugai, MAY 6, 2021, View Source [SID1234579314]).

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"Dynamic landscape of immune cell-specific gene regulation in immune-mediated diseases"

"Chugai’s innovation is generated by its own scientific and technological capabilities. For the maintenance and improvement of state-of-the-art sciences, open innovation including collaboration with academia is essential. I am very proud that one of these efforts to understand disease biology has obtained the world’s highest level of scientific appraisal through the publication in Cell," said Dr. Osamu Okuda, Chugai’s President and CEO. "TOP I 2030, our growth strategy announced in February, places open innovation as one of its key drivers. We will continue expanding our collaboration with external networks to create innovative new drugs."

This study constructed a large-scale functional genome database "ImmuNexUT" (Immune cell gene expression atlas from the University of Tokyo) that significantly outperforms previous reports in the number of cases of immune-mediated diseases, the variety of clinical cases, and the types of immune cells, and clarified the relationship between gene polymorphisms and gene expression levels in each cell type involved in the onset of various immune-mediated diseases. A total of 9,852 samples of 28 immune cells were obtained from 416 peripheral blood samples from 10 representative patients with immunological diseases and healthy individuals, and these samples were used to quantify gene expression and to analyze the association between gene expression and gene polymorphisms. As valuable data showing the genomic functions of Asians, this database is expected to be applied to genomic studies of various disease states involving immunity, leading to the elucidation of disease states and the identification of therapeutic target molecules and biomarkers for pharmaceuticals.

Chugai participated in this collaborative study with the purpose of elucidating the disease state of autoimmune and autoinflammatory diseases and creating therapies through an integrated understanding of immunology and functional genomics. In promoting research, Chugai’s research subsidiary Forerunner Pharma Research which terminated its operation in March 2021 made significant contributions to building ImmuNexUT through acquisition by utilizing its strong immunology research infrastructure with clinical samples.

Chugai, which aims at becoming a top innovator in the healthcare industry, will promote open innovation including collaboration with academia to contribute to patients around the world through innovative drugs.

On May 6, 2021 Genprex, Inc. ("Genprex" or the "Company") (Nasdaq: GNPX), a clinical-stage gene therapy company focused on developing life-changing technologies for patients with cancer and diabetes, reported that the Company and a major cancer research center in Houston, Texas, in March 2021, entered into an amendment (the "Amendment") to their May 2020 License Agreement (the "License Agreement") to grant to Genprex an exclusive worldwide license to an additional portfolio of six patents and one patent application and related technology ("Newly Licensed IP") (Press release, Genprex, MAY 6, 2021, View Source [SID1234579313]). The Newly Licensed IP includes methods for treating non-small cell lung cancer (NSCLC) by administration of a TUSC2 therapeutic in conjunction with EGFR inhibitors or other anti-cancer therapies, in patients who are predicted to be responsive to TUSC2 therapy. A TUSC2 gene-expressing plasmid is the active agent in REQORSA immunogene therapy, Genprex’s lead drug candidate.

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"We are pleased to continue optimizing and expanding our world-class intellectual property portfolio with the addition of these technologies," said Rodney Varner, President and Chief Executive Officer of Genprex. "These new technologies further add to our arsenal of combination therapies for REQORSA, and may enable us to improve patient outcomes through the advancement of multiple therapeutic approaches."

On May 6, 2021 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on developing curative therapeutics using CRISPR/Cas9 technology both in vivo and ex vivo, reported operational highlights and financial results for the first quarter ended March 31, 2021 (Press release, Intellia Therapeutics, MAY 6, 2021, View Source [SID1234579269]).

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"Intellia continues to build momentum as we progress our full-spectrum pipeline towards key upcoming milestones this year. In mid-2021, we anticipate reporting initial clinical data for NTLA-2001 for ATTR, the first-ever systemically delivered CRISPR-based therapy. The company also plans on submitting first-in-human regulatory filings for NTLA-5001 for AML and NTLA-2002 for HAE, and remains on track to nominate at least one additional development candidate from our research efforts," said Intellia President and Chief Executive Officer John Leonard, M.D. "During the first quarter, we shared important advancements that expanded the breadth of our modular platform, such as introducing our proprietary base editor and establishing preclinical proof-of-concept for systemic in vivo editing in bone marrow. We believe our platform innovations will drive future pipeline growth and expand our ability to develop potentially curative treatments for patients with a range of severe diseases."

First Quarter 2021 and Recent Operational Highlights

NTLA-2001 for ATTR: NTLA-2001 is the first systemically delivered CRISPR-based therapy dosed in a patient and could potentially be a curative treatment for ATTR. By applying the Company’s in vivo lipid nanoparticle (LNP) delivery technology, NTLA-2001 offers the possibility of halting and reversing the disease with potent, lifelong transthyretin (TTR) protein reduction after a single administration. NTLA-2001 is part of a co-development/co-promotion agreement between Intellia, the lead party, and Regeneron Pharmaceuticals, Inc. (Regeneron).

The Company anticipates reporting interim clinical data from the ongoing single ascending dose portion of the Phase 1 study evaluating NTLA-2001 in adults with hereditary ATTR with polyneuropathy (hATTR-PN) at a scientific or medical meeting in mid-2021. The data are expected to characterize the emerging safety and activity profile of NTLA-2001 at the initial dose levels.
In March, Intellia announced that the European Commission (EC) granted NTLA-2001 orphan drug designation. Orphan drug designation is granted to therapies that are intended for the treatment, prevention, or diagnosis of life threatening or chronically debilitating rare diseases where there are either no treatments or no satisfactory therapeutic options in the European Union.
Intellia intends to evaluate NTLA-2001 in a broader ATTR population of both polyneuropathy and cardiomyopathy patients following its Phase 1 safety assessment and dose optimization.
NTLA-5001 for AML: NTLA-5001 is a potential best-in-class engineered T cell therapy designed to treat all genetic subtypes of AML. This investigational candidate is an autologous T cell receptor (TCR)-T cell therapy targeting the Wilms’ Tumor 1 (WT1) antigen utilizing Intellia’s proprietary cell engineering process.

Intellia expects to submit an Investigational New Drug (IND) application or equivalent regulatory application for NTLA-5001 in mid-2021. This first-in-human trial is expected to evaluate the safety and activity of NTLA-5001 in patients with persistent or recurrent AML who have previously received first-line therapies.
The Company is evaluating the potential of NTLA-5001 to treat WT1-positive solid tumors in preclinical studies.
NTLA-2002 for HAE: NTLA-2002 aims to prevent attacks for people living with HAE after treatment consisting of a single administration. Intellia is applying its modular LNP delivery system to develop NTLA-2002 to knock out the KLKB1 gene in the liver to permanently reduce plasma kallikrein activity. This approach is expected to provide continuous suppression of kallikrein activity and eliminate the significant treatment burden associated with currently available therapies for HAE patients.

The Company expects to submit an IND or equivalent regulatory application for NTLA-2002 in the second half of 2021. Intellia is leveraging insights gained from the development of NTLA-2001 to expedite clinical development of NTLA-2002. The first-in-human trial is expected to evaluate safety, tolerability and activity in patients with HAE.
In March, Intellia presented preclinical results confirming greater reductions in serum kallikrein protein levels and activity versus the current standard of care for HAE, sustained over 17 months following a single dose in an ongoing non-human primate study of its cyno-specific LNP formulation for NTLA-2002. Additionally, the Company presented data from a humanized KLKB1 mouse model of bradykinin-mediated vascular permeability, establishing that a single administration of NTLA-2002 prevented captopril-induced vascular leakage. These results, which affirm NTLA-2002’s therapeutic hypothesis of preventing HAE attacks, were presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2021 Annual Meeting.
Modular Platform and Pipeline Expansion: Intellia is advancing its modular platform technologies to broaden the in vivo and ex vivo applications of genome editing. This includes progressing capabilities for innovative CRISPR/Cas9-mediated targeted transgene insertion, in vivo editing in multiple tissue types and an allogeneic approach for the development of "off-the-shelf" T cell therapies. These efforts will support new therapeutic candidates for genetic diseases, requiring removal and/or restoration of a protein, and next-generation engineered cell therapies for cancers and autoimmune diseases.

Intellia remains on track to nominate at least one additional development candidate in 2021.
The Company plans to present preclinical data at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 24th Annual Meeting, taking place virtually May 11 – 14, 2021, highlighting research advancements and platform innovations.
In March, the Company presented preclinical data introducing Intellia’s novel, proprietary cytosine deaminase base editing technology. The data demonstrated the technology’s potential for enhanced cell engineering, with multiple simultaneous gene knockouts achieving >90% T cell editing efficiency and no detectable increase in translocation above background levels. These results, which expand Intellia’s modular ex vivo capabilities, were presented at the seventh Cold Spring Harbor Laboratory (CSHL) virtual scientific meeting on Nucleic Acid Therapies.
In March, the Company presented preclinical data establishing proof-of-concept for systemic, in vivo genome editing in a tissue outside the liver. Intellia’s non-viral delivery platform achieved dose-dependent, therapeutically meaningful editing of bone marrow and hematopoietic stem cells (HSCs), lasting one year following a single dose in mice. These results, which extend Intellia’s modular in vivo capabilities to treat inherited blood disorders such as sickle cell disease, were presented at the Keystone eSymposium: Precision Engineering of the Genome, Epigenome and Transcriptome.
Board of Directors:

In April, Intellia appointed Georgia Keresty, Ph.D., M.P.H., to the Company’s Board of Directors. Dr. Keresty has held key global roles in pharmaceutical research and development, operations, manufacturing and distribution, quality, compliance and regulatory affairs. Most recently, Dr. Keresty served as chief operating officer and global head, medical sciences and development operations for Takeda Research and Development, a division of Takeda Pharmaceuticals USA, Inc.
Upcoming Events

The Company will participate in the following events during the second quarter of 2021:

ASGCT 24th Annual Meeting, May 11–14, Virtual
Jefferies Healthcare Conference, June 2, Virtual
Upcoming Milestones

The Company has set forth the following for pipeline progression:

ATTR: Report initial clinical data from Phase 1 study of NTLA-2001 in mid-2021
AML: Submit an IND or IND-equivalent for NTLA-5001 in mid-2021
HAE: Submit an IND or IND-equivalent for NTLA-2002 in 2H 2021
Nominate at least one new development candidate in 2021
First Quarter 2021 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $600.8 million as of March 31, 2021, compared to $597.4 million as of December 31, 2020. The increase was driven by $45.3 million of net equity proceeds raised from the Company’s "At the Market" (ATM) agreement, $13.3 million in proceeds from employee-based stock plans and $2.4 million from the Regeneron collaboration. These increases were offset in part by cash used to fund operations of approximately $57.6 million.
Collaboration Revenue: Collaboration revenue decreased by $6.5 million to $6.4 million during the first quarter of 2021, compared to $12.9 million during the first quarter of 2020. The decrease was primarily driven by the $5.0 million milestone payment earned from Novartis Institutes for BioMedical Research, Inc. (Novartis) for the IND submission of OTQ923 in 2020.
R&D Expenses: Research and development expenses increased by $4.6 million to $39.3 million during the first quarter of 2021, compared to $34.7 million during the first quarter of 2020. This increase was primarily driven by the advancement of our lead programs, research personnel growth to support these programs, and expansion of the development organization.
G&A Expenses: General and administrative expenses increased by $2.3 million to $13.6 million during the first quarter of 2021, compared to $11.3 million during the first quarter of 2020. This increase was primarily related to employee related expenses, including stock-based compensation of $0.9 million.
Net Loss: The Company’s net loss was $46.2 million for the first quarter of 2021, compared to $31.8 million during the first quarter of 2020.
Financial Guidance

Intellia expects that its cash, cash equivalents and marketable securities as of March 31, 2021 will enable the Company to fund its robust R&D plans, anticipated operating expenses and capital expenditure requirements at least through the next 24 months. This expectation excludes any strategic use of capital not currently in the Company’s base-case planning assumptions.

Conference Call to Discuss First Quarter Earnings

The Company will discuss these results on a conference call today, May 6, 2021, at 8 a.m. E.T.

To join the call:

U.S. callers should dial 1-833-316-0545 and international callers should dial 1-412-317-5726, approximately five minutes before the call.
All participants should ask to be connected to the Intellia Therapeutics conference call.
A replay of the call will be available through the Events and Presentations page of the Investors & Media section on Intellia’s website at www.intelliatx.com beginning on May 6, 2021 at 12 p.m. E.T.