On May 12, 2021 Chinook Therapeutics, Inc. (Nasdaq: KDNY), a biopharmaceutical company focused on the discovery, development and commercialization of precision medicines for kidney diseases, reported financial results for the first quarter ended March 31, 2021 (Press release, Aduro Biotech, MAY 12, 2021, View Source [SID1234579763]).

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"During the first quarter of 2021, Chinook made strong progress with its pipeline of programs for kidney diseases, including initiating the phase 3 ALIGN and phase 2 AFFINITY trials of atrasentan, presenting encouraging clinical data from the BION-1301 program and entering into a strategic collaboration with Evotec," said Eric Dobmeier, president and chief executive officer of Chinook Therapeutics. "We are well-capitalized and resourced to execute across our programs to generate additional data catalysts and continue building Chinook into a leading kidney disease company."

Recent Highlights

Presented Gd-IgA1 biomarker data in healthy volunteers from Part 1 (single ascending dose) and Part 2 (multiple ascending dose) of the ongoing phase 1b study of BION-1301 at the ISN World Congress of Nephrology 2021, showing dose-dependent and durable reductions in Gd-IgA1 levels following administration of BION-1301.

Presented data from the BION-1301 phase 1 intravenous to subcutaneous bioavailability study in healthy volunteers at the ISN World Congress of Nephrology 2021, demonstrating our ability to transition to subcutaneous administration of BION-1301 in cohort 2 of the ongoing phase 1b and future studies.

Enrolled the first patient in the phase 2 AFFINITY basket trial of atrasentan, a highly potent and selective endothelin A receptor (ETA) antagonist (see www.clinicaltrials.gov, identifier NCT04573920). Chinook expects to report data from initial patient cohorts of this study in 2022.

Enrolled the first patient with IgA nephropathy (IgAN) in the phase 3 ALIGN trial of atrasentan, (see www.clinicaltrials.gov, identifier NCT04573478). Chinook expects to report top-line proteinuria data from this study in 2023 to support potential accelerated approval from the FDA.

Entered into a strategic collaboration with Evotec to discover and develop novel precision medicine therapies for lupus nephritis, IgAN, polycystic kidney disease (PKD) and other primary glomerular diseases by leveraging the National Unified Renal Translational Research Enterprise (NURTuRE) patient biobank and Evotec’s proprietary PanHunter multi-omics platform.

Received rare pediatric disease designation from the U.S. Food and Drug Administration (FDA) for CHK-336, an investigational oral small molecule inhibitor of lactate dehydrogenase A (LDHA), for primary hyperoxaluria (PH).
Anticipated Upcoming Catalysts

Part 3 of Chinook’s phase 1b study of BION-1301 is currently enrolling IgAN patients in an open-label setting, and Chinook expects to present a small subset of interim patient data in an oral presentation at the 58th ERA-EDTA Congress in June, as well as additional patient data at the ASN Kidney Week 2021 in November.

CHK-336 is currently in IND-enabling studies and advancing towards an expected IND submission in late 2021 or early 2022 for the treatment of primary hyperoxaluria.
First Quarter 2021 Financial Results

Cash Position – Cash, cash equivalents and marketable securities totaled $222.6 million at March 31, 2021, compared to $250.4 million at December 31, 2020.

Revenue – Total revenue increased by $0.4 million for the first quarter of 2021 compared to the same period in 2020 due to revenue recognized related to research and development services provided under the collaboration agreement with Lilly, which was acquired under the merger with Aduro.

Expenses –

Research and development expenses were $25.7 million for the first quarter of 2021 compared to $2.8 million for the same period in 2020. The increase was primarily due to external clinical and manufacturing expenses related to the atrasentan and BION-1301 clinical programs; higher employee-related costs, including salaries, benefits and stock-based compensation expense associated with hiring staff to build out our clinical and development capabilities; increased spending for consulting and outside services; and higher facilities and other costs. The three months ended March 31, 2021 also includes an upfront fee of $3.3 million due to Evotech International GmbH under a research collaboration and license agreement entered into in February 2021.

General and administrative expenses were $9.5 million for the first quarter of 2021 compared to $1.3 million for the same period in 2020. The increase was primarily due to higher employee-related costs, including salaries, benefits and stock-based compensation expense associated with the addition of administrative staff to buildout our public-company infrastructure; higher legal, consulting and outside services costs; and an increase in facilities and other costs.

Expenses due to change in fair value of contingent consideration and amortization of intangibles were $2.3 million for the first quarter of 2021 compared to nil for the same period in 2020. These non-cash expenses are due to the quarterly revaluation of assets and liabilities related to the merger with Aduro.

Net Loss – Net loss for the first quarter of 2021 was $37.2 million or $0.88 per share compared to net loss of $5.1 million or $1.25 per share for the same period in 2020.

Cash Used in Operations – For the first quarter ended March 31, 2021, cash used in operations totaled $28.1 million.

On May 12, 2021 Exicure, Inc. (NASDAQ: XCUR), a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) technology, reported financial results for the quarter ended March 31, 2021 and provided an update on corporate progress (Press release, Exicure, MAY 12, 2021, View Source [SID1234579780]).

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"Exicure is off to a strong start in 2021, as we continue to advance our clinical and pre-clinical programs and add depth to our Board of Directors and management team," commented Dr. David Giljohann, Exicure’s Chief Executive Officer. "In the first quarter, cavrotolimod (AST-008) was granted two Fast Track designations and an Orphan Drug designation from the U.S. Food and Drug Administration. We also strengthened our Board of Directors with the appointments of Mr. James Sulat, Dr. Elizabeth Garofalo, and Mr. Andrew Sassine, and added expertise to our management team with the additions of Ms. Rebecca Peterson, VP, Investor Relations & Corporate Communications and Ms. Sarah Longoria, VP, Human Resources. We believe we are well positioned to execute on upcoming clinical milestones and operational goals for the remainder of 2021."

Pipeline Highlights

Immuno-Oncology – Cavrotolimod (AST-008)

The U.S. Food and Drug Administration (FDA) granted two Fast Track designations for cavrotolimod in January 2021:
Cavrotolimod in combination with anti-programmed death (PD)-1 or anti-PD ligand 1 (PD-L1) therapy for the treatment of patients with locally advanced or metastatic Merkel cell carcinoma (MCC), refractory to prior anti-PD-(L)1 blockade.
Cavrotolimod in combination with anti-PD-1 therapy for the treatment of patients with locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC), refractory to prior anti-PD-1 blockade.
The FDA granted Orphan Drug designation for cavrotolimod for the treatment of patients with MCC in March 2021.
The Phase 1b/2 clinical trial of intra-tumoral cavrotolimod in combination with approved checkpoint inhibitors pembrolizumab or cemiplimab, for the treatment of patients with advanced or metastatic MCC or CSCC, is open and actively enrolling patients:
In the first quarter of 2021, the Company continued enrolling patients in the Phase 2 dose expansion stage of the Phase 1b/2 clinical trial.
As of April 22, 2021, 20 clinical trial sites are open for enrollment and seven additional sites are pending activation. The Company plans to open up to 30 sites for the Phase 2 stage of the clinical trial.
The Company expects to provide interim results from the Phase 2 portion of the clinical trial in mid-2021, and we expect to report overall response rate (ORR) results in the first half of 2022.
Neurology – XCUR-FXN

The Company hosted a virtual R&D Day in January 2021 to discuss progress within its neurology pipeline, which included an overview of the Company’s XCUR-FXN path to clinical validation for the treatment of Friedreich’s Ataxia (FA).
During the first quarter of 2021, the Company continued to advance preclinical and IND-enabling studies of XCUR-FXN in FA and disclosed encouraging preclinical mouse data, demonstrating significant upregulation of XCUR-FXN components in the brain and spinal cord. The Company believes these data support the potential for XCUR-FXN as a disease-modifying treatment for the disease.
The Company is on track with prior guidance to submit an IND for XCUR-FXN in FA by year-end 2021 and expects to initiate a first-in-patient Phase 1b clinical trial of XCUR-FXN in FA in the first half of 2022.
First Quarter Financial Results and Financial Guidance

Cash Position: Cash, cash equivalents and short-term investments were $67.4 million as of March 31, 2021 compared to $82.1 million as of December 31, 2020.

Research and Development (R&D) Expenses: R&D expenses were $10.3 million for the quarter ended March 31, 2021, compared to $6.1 million for the quarter ended March 31, 2020. The Company has increased full-time headcount in R&D from 36 at March 31, 2020 to 54 at March 31, 2021. The increase in R&D expense reflects this increased headcount and the related increase in R&D activities, in addition to increased clinical trial activities.

General and Administrative Expenses: General and administrative expenses were $2.9 million for the quarter ended March 31, 2021, compared to $2.6 million for the quarter ended March 31, 2020. This increase is primarily due to costs related to new hires needed to grow the Company as it evolves.

Net Loss: Exicure had a net loss of $12.5 million for the quarter ended March 31, 2021 compared to net income of $1.2 million for the quarter ended March 31, 2020. The increase in net loss was primarily driven by lower revenue associated with Exicure’s collaboration with AbbVie as well as higher R&D costs to advance our pipeline.

Cash Runway Guidance: The Company believes that, based on its current operating plans and estimates of future expenses, as of the date of this press release, its existing cash, cash equivalents and short-term investments will be sufficient to fund its operations for at least the next 12 months.

About Friedreich’s Ataxia (FA)

FA is a rare, degenerative, life-shortening neuro-muscular disorder that affects children and adults, and involves the loss of strength and coordination usually leading to wheelchair use, diminished vision, hearing and speech, scoliosis, increased risk of diabetes, and a life-threatening heart condition. There are currently no FDA-approved treatments. The Company estimates that approximately 13,000 patients across the United States, Europe, Canada and Australia are affected by FA.

On May 12, 2021 NEC Corporation (NEC; TSE: 6701) reported differences between the consolidated financial forecasts announced on January 29, 2021 and results for the fiscal year ended March 31, 2021 (Press release, NEC, MAY 12, 2021, View Source [SID1234579796]).

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1. Differences between the consolidated financial forecasts and results for the fiscal year ended March 31, 2021 (April 1, 2020 to March 31, 2021)

2. Reasons for differences in forecasts and results
In terms of consolidated revenue, the Network Services business and Public Infrastructure business exceeded expectations due to the full-scale provision of 5G base stations and demand related to GIGA schools. However, due to worsening market conditions caused by the spread of the new coronavirus, the Enterprise businesses and Public Solutions business fell short of expectations, resulting in a decrease in consolidated revenue from the previous forecast.

Regarding consolidated operating profit and consolidated adjusted operating profit, in addition to improvement in the Network Services business from an increase in sales, gains were also recorded from the sale of land and the sale of subsidiary shares, resulting in an improvement over the previous forecast.

Net profit attributable to owners of the parent and adjusted net profit attributable to owners of the parent improved compared to previous forecasts due to improved consolidated operating profit and reduced tax expenses.

Cautionary Statement with Respect to Forward-Looking Statements
This material contains forward-looking statements regarding estimations, forecasts, targets and plans in relation to the results of operations, financial conditions and other overall management of the NEC Group (the "forward-looking statements"). The forward-looking statements are made based on information currently available to NEC and certain assumptions considered reasonable as of the date of this material. These determinations and assumptions are inherently subjective and uncertain. These forward-looking statements are not guarantees of future performance, and actual operating results may differ substantially due to a number of factors.

The factors that may influence the operating results include, but are not limited to, the following:

adverse economic conditions in Japan or internationally;
foreign currency exchange and interest rate risks;
changes in the markets in which we operate;
the recent outbreak of the novel coronavirus;
potential inability to achieve the goals in our medium-term management plan;
fluctuations in our revenue and profitability from period to period;
difficulty achieving the benefits expected from acquisitions, business combinations and reorganizations;
potential deterioration in our relationships with strategic partners or problems relating to their products or services;
difficulty achieving our growth strategies outside Japan;
potential inability to keep pace with rapid technological advancements in our industry and to commercialize new technologies;
intense competition in the markets in which we operate;
risks relating to our concentrated customer base;
difficulties with respect to new businesses;
potential failures in the products and services we provide;
potential failure to procure components, equipment or other supplies;
difficulties protecting our intellectual property rights;
potential inability to obtain certain intellectual property licenses;
our customers may encounter financial difficulties;
difficulty attracting, hiring and retaining skilled personnel;
difficulty obtaining additional financing to meet our funding needs;
potential failure of internal controls;
potentially costly and time-consuming legal proceedings;
risks related to regulatory change and uncertainty;
risks related to environmental laws and regulations;
information security and data protection concerns and restrictions;
potential changes in effective tax rates or deferred tax assets, or adverse tax examinations;
risks related to corporate governance and social responsibility requirements;
risks related to natural disasters, public health issues, armed hostilities and terrorism;
risks related to our pension assets and defined benefit obligations; and
risks related to impairment losses with regard to goodwill.

On May 12, 2021 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), a biopharmaceutical company developing and commercializing specialty products for respiratory disease, allergy and opioid overdose, reported that it will host an investor conference call on Monday, May 17, 2021 at 2 p.m. Pacific Time to discuss its financial and operating results for the first quarter of 2021 as well as provide a business update (Press release, Adamis Pharmaceuticals, MAY 12, 2021, View Source [SID1234579814]). The company’s press release concerning its first quarter 2021 financial results will be available after 1 p.m. Pacific Time on May 17, 2021 and on its website at www.adamispharmaceuticals.com, and the company also expects to file its quarterly report on Form 10-Q for the quarter ended March 31, 2021 on that date.

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Dennis J. Carlo, Ph.D., President and CEO of Adamis, will host the call along with other members of the management team. The call is open to the public and will provide an update on recent developments, events that have taken place during the quarter, and certain target milestones and goals for future periods. Forward-looking statements concerning expectations regarding future company performance may be made during the conference call.

A live audio webcast of the conference call will also be available via this link – View Source, with a replay available shortly after the live event.

On May 12, 2021 Evogene Ltd. (NASDAQ: EVGN) (TASE: EVGN), a leading computational biology company aiming to revolutionize life-science product development across several market segments, reported that it will release its financial results for the first quarter of 2021 on Wednesday, May 26th, 2021 (Press release, Evogene, MAY 12, 2021, View Source [SID1234579831]). Mr. Ido Dor, Chief Executive Officer of Evogene’s subsidiary, Lavie Bio Ltd., will join the conference call to discuss Lavie Bio’s recent activity.

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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

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On the day of the announcement, the Company’s management will host a conference call to discuss the results at 09:00 AM Eastern time, 16:00 Israel time. To access the conference call, please dial +1-888-281-1167 toll free from the United States, or +972-3-918-0609 internationally. Access to the call will also be available via live webcast through the Company’s website at www.evogene.com.

A replay of the conference call will be available approximately two hours following the completion of the call. To access the replay, please dial 1-888-326-9310 toll free from the United States, or +972-3-925-5901 internationally. The replay will be accessible through May 28th, and an archive of the webcast will be available on the webcast link for the following twelve months.