On May 9, 2019 Blaze Bioscience, Inc., the Tumor Paint Company, a biotechnology company dedicated to improving the lives of cancer patients through development and commercialization of products for fluorescence guided surgery, reported the publication of Phase 1 results in the peer-reviewed journal Neurosurgery (Press release, Blaze Bioscience, MAY 9, 2019, View Source [SID1234536085]). The publication entitled "Phase 1 Safety, Pharmacokinetics, and Fluorescence Imaging Study of Tozuleristide (BLZ-100) in Adults with Newly Diagnosed or Recurrent Gliomas" by Patil et al is available online in Neurosurgery Now!.

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The publication reports data from 17 subjects in a single dose, dose-escalation, open-label clinical trial conducted at Cedars-Sinai Medical Center in Los Angeles and the NEWRO Foundation in Brisbane, Australia. The primary objective of the study was to evaluate the safety and tolerability of tozuleristide in adult subjects with glioma undergoing surgery. Tozuleristide was found to be well tolerated at all tested doses with no dose limiting toxicities observed. A maximum tolerated dose was not reached. Exploratory imaging studies were conducted with the FLUOBEAM800 (Fluoptics), Odyssey CLx (LI-COR Biosciences) and SIRIS (Teal Light Surgical) imaging devices. Fluorescence signal was detected in both high- and low-grade tumors and was visible from 3 hours to 27 hours post dosing.

"Tozuleristide fluorescence visualized with a high-resolution imaging system shows great promise as a tool to increase extent of resection for both high- and low-grade gliomas while preserving critical normal brain tissue. Improved resection is the single most important factor for improving survival and quality of life in brain tumor patients. Based on these encouraging results, further clinical trials are definitely warranted," said Dr. Adam Mamelak, MD, neurosurgeon at Cedars-Sinai and senior author on the publication.

"The positive data in adult glioma subjects has paved the way for our broader pediatric brain cancer clinical trials," said Dr. Dennis Miller, Blaze Bioscience SVP of Development. "The study also pointed out the need for improved imaging devices for brain cancer surgery applications which led to the development of the Canvas Imaging System being used in our ongoing pivotal study."

About BLZ-100 (tozuleristide)

BLZ-100 (tozuleristide) is the first product candidate from Blaze’s Tumor Paint platform and consists of a targeting peptide and a fluorescent dye, which emits light in the near-infrared (NIR) range. Tumor Paint products are designed to provide real-time, high-resolution intraoperative visualization of cancer cells throughout surgery, potentially enabling more precise, complete resection of cancer while sparing normal adjacent tissue. BLZ-100 has been tested in four Phase 1 clinical trials and has demonstrated clinical proof of concept in brain, breast and skin cancers. Additional potential applications of BLZ-100 include prostate, lung, colorectal and other solid tumor cancers. BLZ-100, an investigational agent, is being evaluated in a pivotal Phase 2/3 clinical study in pediatric central nervous system tumors. More details about ongoing trials are available at www.clinicaltrials.gov.

About the Canvas Imaging System

The Canvas Imaging System is an investigational medical device designed to provide high-sensitivity detection of NIR light in the operating room under ambient light conditions. The Canvas Imaging System was developed and is manufactured by Teal Light Surgical, Inc. (a wholly owned subsidiary of Blaze Bioscience, Inc.). The first Canvas Imaging System under development is adapted for use with surgical microscopes and detects both BLZ-100 and indocyanine green (ICG).

On May 9, 2019 Blueprint Medicines Corporation (NASDAQ:BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, reported financial results and provided a business update for the quarter ended March 31, 2019 (Press release, Blueprint Medicines, MAY 9, 2019, View Source [SID1234536083]).

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"Based on significant clinical and regulatory progress in the first quarter, we accelerated multiple programs and advanced our ‘2020 Blueprint’ strategy to transform Blueprint Medicines into a fully-integrated precision therapy company," said Jeff Albers, Chief Executive Officer of Blueprint Medicines. "We are especially encouraged that the FDA granted Breakthrough Therapy Designation to BLU-667 for RET-fusion-positive NSCLC, and we look forward to presenting updated data from our Phase 1 ARROW trial at the ASCO (Free ASCO Whitepaper) Annual Meeting next month. In addition, our follow-on public offering in April further strengthened our financial position, enabling us to continue to build the company ahead of multiple planned marketing applications for avapritinib and BLU-667 in the United States and Europe over the next 18 months."

First Quarter 2019 Highlights and Recent Progress:

Avapritinib: Gastrointestinal stromal tumors (GIST):

Announced plans to submit a marketing authorization application (MAA) to the European Medicines Agency (EMA) for avapritinib for the treatment of PDGFRα D842V mutant GIST and fourth-line GIST in the third quarter of 2019.
Avapritinib: Systemic mastocytosis (SM):

Announced plans to accelerate the submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for avapritinib for the treatment of advanced SM in the first quarter of 2020, subject to continuing discussions with the FDA to determine the required clinical data for an NDA submission.
BLU-667: RET-altered solid tumors:

Received FDA Breakthrough Therapy Designation for BLU-667 for the treatment of patients with RET fusion-positive non-small cell lung cancer (NSCLC) that has progressed following platinum-based chemotherapy.
Announced top-line interim data from the Phase 1 ARROW trial of BLU-667 in patients with previously treated RET-fusion NSCLC and previously treated RET-mutant medullary thyroid cancer (MTC). Read the full data here.
Achieved enrollment targets for registration-enabling ARROW trial cohorts for patients with previously treated RET-fusion NSCLC and previously treated RET-mutant MTC. Based on the early achievement of the enrollment target for the RET-fusion NSCLC cohort, Blueprint Medicines plans to submit an NDA to the FDA for BLU-667 for the treatment of patients with NSCLC previously treated with platinum-based chemotherapy in the first quarter of 2020. Blueprint Medicines continues to expect to submit an NDA to the FDA for BLU-667 for the treatment of patients with RET-mutant MTC previously treated with an approved multi-kinase inhibitor in the first half of 2020.
BLU-554: Advanced hepatocellular carcinoma (HCC)

Dosed the first patient in China in the ongoing Phase 1 clinical trial of BLU-554 in patients with advanced HCC, under Blueprint Medicines’ collaboration with CStone Pharmaceuticals.
BLU-782: Fibrodysplasia ossificans progressiva (FOP):

Initiated a Phase 1 clinical trial for BLU-782 in healthy volunteers and, based on the progress of the ongoing trial and input from clinical experts, announced plans to initiate a Phase 2 clinical trial of BLU-782 in patients with FOP in the fourth quarter of 2019.
Corporate:

Closed an underwritten public offering of 4,662,162 shares of common stock at a public offering price of $74.00 per share, including the exercise in full by the underwriters of their option to purchase additional shares of common stock. Blueprint Medicines received estimated net proceeds of approximately $327.2 million, after deducting underwriting discounts and commissions and estimated offering expenses.
Key Upcoming Milestones:

The company expects to achieve the following near-term milestones:

Submit an NDA to the FDA and an MAA to the EMA for avapritinib for the treatment of patients with PDGFRA Exon 18 mutant GIST and fourth-line GIST in the second quarter and third quarter of 2019, respectively.
Present the registration dataset for avapritinib in PDGFRA Exon 18 mutant GIST and fourth-line GIST at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
Present updated data from the Phase 1 EXPLORER trial of avapritinib in advanced SM at the 24th Annual Congress of the European Hematology Society.
Present updated data from the Phase 1 ARROW trial of BLU-667 in RET-altered cancers at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting.
First Quarter 2019 Financial Results:

Cash Position: As of March 31, 2019, cash, cash equivalents and investments were $415.9 million, as compared to $494.0 million as of December 31, 2018. This decrease was primarily related to cash used in operating activities. Cash, cash equivalents and investments as of March 31, 2019 do not include the estimated net proceeds of approximately $327.2 million from the company’s follow-on underwritten public offering of common stock, which closed in April 2019.
Collaboration Revenues: Collaboration revenues were $0.7 million for the first quarter of 2019, as compared to $1.0 million for the first quarter of 2018. This decrease was primarily due to revenue recorded under the Roche collaboration.
R&D Expenses: Research and development expenses were $74.3 million for the first quarter of 2019, as compared to $50.0 million for the first quarter of 2018. This increase was primarily due to increased clinical and manufacturing expenses driven by our lead development candidates and increased personnel-related expenses. Research and development expenses included $5.8 million in stock-based compensation expenses for the first quarter of 2019.
G&A Expenses: General and administrative expenses were $16.6 million for the first quarter of 2019, as compared to $9.9 million for the first quarter of 2018. This increase was primarily due to increased personnel-related expenses, commercial-readiness activities and increased other professional fees. General and administrative expenses included $4.5 million in stock-based compensation expenses for the first quarter of 2019.
Net Loss: Net loss was $87.4 million for the first quarter of 2019, or a net loss per share of $1.98, as compared to a net loss of $56.5 million for the first quarter of 2018, or a net loss per share of $1.29.
Financial Guidance:

Based on its current plans, Blueprint Medicines expects that its existing cash, cash equivalents and investments, including the estimated net proceeds of approximately $327.2 million from its April 2019 follow-on public offering but excluding any potential option fees and milestone payments under its existing collaborations with Roche and CStone Pharmaceuticals, will be sufficient to enable it to fund its operating expenses and capital expenditure requirements into the middle of 2021.

Conference Call Information:

Blueprint Medicines will host a live conference call and webcast at 8:30 a.m. ET today to discuss first quarter 2019 financial results and recent business activities. The conference call may be accessed by dialing (855) 728-4793 (domestic) or (503) 343-6666 (international) and referring to conference ID 9671728. A webcast of the conference call will be available in the Investors section of the Blueprint Medicines’ website at View Source The archived webcast will be available on Blueprint Medicines’ website approximately two hours after the conference call and will be available for 30 days following the call.

On May 9, 2019 Medigene AG (FSE: MDG1, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies, reported that the Company’s strategic partner bluebird bio, Inc. (NASDAQ:BLUE), USA, at its analyst day presentation, will present preclinical data of the first therapeutic T cell receptor (TCR) candidate resulting from the research and development partnership with Medigene (Press release, MediGene, MAY 9, 2019, View Source [SID1234536082]). Furthermore, bluebird bio announced plans to start clinical development in 2020 with this candidate TCR targeting the tumor antigen MAGE-A4, which is expressed on a variety of solid tumor types.

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The presented preclinical data demonstrate a high antigen sensitivity of the MAGE-A4-TCR with strong recognition of tumor cell lines and durable tumor elimination in a subcutaneous in vivo melanoma model. Furthermore, the data show functional responses in both CD8+ and CD4+ T cell populations, suggesting that no co-receptor will be needed for use of the MAGE-A4-TCR in solid tumors. The high functional avidity of this TCR enables it to trigger killing by CD4+ T cells in addition to CD8+ T cells, helping to potentially overcome immune suppression that is often prevalent in solid tumor microenvironments.

bluebird bio revealed its plans to start clinical development for this TCR-T-cell therapy for solid tumors in 2020, and may potentially combine this highly active TCR with other technologies to enhance T cell function in solid tumor microenvironments in next generation programs.

Prof. Dolores Schendel, CEO/CSO of Medigene, comments: "We are excited that already the first TCR discovery project that we performed for our partner bluebird bio yielded a TCR candidate displaying such convincing preclinical data and that it has been selected for clinical development by bluebird bio. This confirms the high quality of Medigene’s TCR discovery platform and supports our confidence in our further projects with bluebird bio"

This is the first collaboration target of Medigene’s partnership with bluebird bio of a potential six TCR products that the companies have agreed to work on together.

To see the full webcast of bluebird bio’s analyst day, please follow this link: View Source

Medigene AG (FSE: MDG1, ISIN DE000A1X3W00, Prime Standard) is a publicly listed biotechnology company headquartered in Martinsried near Munich, Germany. The company is developing highly innovative immunotherapies to target various forms and stages of cancer. Medigene concentrates on the development of personalized T cell-based therapies with the focus on T cell-receptor modified T cells (TCR-Ts) and has associated projects currently in pre-clinical and clinical development. For more information, please visit View Source

This press release contains forward-looking statements representing the opinion of Medigene as of the date of this release. The actual results achieved by Medigene may differ significantly from the forward-looking statements made herein. Medigene is not bound to update any of these forward-looking statements. Medigene is a registered trademark of Medigene AG. This trademark may be owned or licensed in select locations only.

Contact Medigene AG
Julia Hofmann, Dr. Robert Mayer
Tel.: +49 – 89 – 20 00 33 – 33 01,
email: [email protected]

On May 9, 2019 Reata Pharmaceuticals, Inc. (Nasdaq: RETA), a clinical-stage biopharmaceutical company, reported financial results for the first quarter ended March 31, 2019, and provided an update on the Company’s business and product development programs (Press release, Reata Pharmaceuticals, MAY 9, 2019, View Source [SID1234536081]).

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Product Development Updates

Phase 2/3 CARDINAL Trial of Bardoxolone in Alport Syndrome

Enrollment in the pivotal Phase 3 portion of the CARDINAL trial of bardoxolone methyl (bardoxolone) in patients with chronic kidney disease (CKD) caused by Alport syndrome is complete at 157 patients. Alport syndrome is a rare and serious hereditary disease that affects approximately 30,000 to 60,000 patients in the United States. There are no approved therapies for Alport syndrome anywhere in the world. We expect to have one-year top-line results available in the second half of 2019.

Phase 2 PHOENIX Trial of Bardoxolone in Rare Forms of Chronic Kidney Disease

In the first quarter of 2019, we announced final data from the cohort of patients with focal segmental glomerulosclerosis (FSGS) from the Phase 2 PHOENIX study of bardoxolone in rare forms of CKD, as well as aggregate data across all four cohorts of PHOENIX. PHOENIX was an open-label, multi-center Phase 2 trial evaluating the safety and efficacy of bardoxolone in 103 patients, including 31 patients with autosomal dominant polycystic kidney disease (ADPKD), 26 with IgA nephropathy, 28 with CKD caused by type 1 diabetes, and 18 with FSGS. Patients were treated with bardoxolone for 12 weeks, and each cohort showed statistically significant increases in mean estimated glomerular filtration rate (eGFR) at Week 12. The mean change in eGFR from baseline across all four cohorts was 7.8 mL/min/1.73 m2 (n=103; p<0.00001). Of the patients that reached Week 12, 88% experienced increases in eGFR. Bardoxolone significantly reduced mean systolic blood pressure by 3.8 mmHg (n=103; p=0.002) and mean diastolic blood pressure by 2.8 mmHg (n=103; p=0.0009). Urinary albumin excretion was low upon study entry and remained unchanged by bardoxolone treatment (n=103; p=0.6). No severe adverse events were reported related to bardoxolone treatment.

Phase 3 FALCON Trial of Bardoxolone in Autosomal Dominant Polycystic Kidney Disease

Based on the results from the ADPKD cohort of PHOENIX, we announced in January of 2019 that we will initiate a registrational Phase 3 trial called FALCON in patients with ADPKD. ADPKD is the most common single-gene disorder of the kidneys, and there are an estimated 400,000 patients in the United States, with approximately 140,000 diagnosed. The only therapy currently approved for the treatment of ADPKD is tolvaptan, which was approved in the United States in 2018.

FALCON is an international, multi-center, randomized, double-blind, placebo-controlled trial studying the safety and efficacy of bardoxolone in approximately 300 patients with ADPKD randomized one-to-one to active drug or placebo. The primary efficacy endpoint is the retained eGFR benefit, defined as the change from baseline in eGFR compared to placebo after 48 weeks of treatment and a four-week drug withdrawal period. Based upon guidance from the FDA, the 52-week retained eGFR benefit data may support accelerated approval under subpart H. After Week 52, patients will be restarted on study drug with their original treatment assignments and will continue on study for a second year. The second-year retained eGFR benefit will be measured at Week 104 after withdrawal of drug for four weeks. Based upon guidance from the FDA, the year-two retained eGFR benefit data may support full approval. We plan to enroll the first ADPKD patient in FALCON in May 2019.

Pivotal MOXIe Trial of Omaveloxolone in Friedreich’s Ataxia

We are conducting the pivotal part 2 of the MOXIe Phase 2 trial of omaveloxolone in Friedreich’s ataxia, an inherited, debilitating, and degenerative neuromuscular disorder. Enrollment in part 2 of the MOXIe trial is complete at 103 patients, and top-line data are expected in the second half of 2019.

Phase 3 CATALYST Trial of Bardoxolone in Connective Tissue Disease-Associated Pulmonary Arterial Hypertension

We are conducting the pivotal Phase 3 CATALYST trial of bardoxolone in patients with pulmonary arterial hypertension associated with connective tissue disease (CTD-PAH), an often fatal manifestation of many types of autoimmune disease, including systemic sclerosis (scleroderma) and systemic lupus erythematosus. The trial will enroll approximately 200 patients, with top-line data expected in the first half of 2020.

Selected Clinical Milestones in 2019

Initiation of pivotal FALCON trial in ADPKD in May 2019
Pivotal CARDINAL data in the second half of 2019
Pivotal MOXIe data in the second half of 2019
First Quarter Results

The Company incurred total expenses of $36.3 million for the quarter ended March 31, 2019, with research and development accounting for $26.1 million. This compares to total expenses of $28.1 million for the same period of the year prior, when research and development accounted for $21.4 million. We reported a net loss of $29.2 million or $0.98 per share for the quarter ended March 31, 2019. This compares to net income of $4.1 million or $0.16 per share in the same period of the year prior.

The net loss for the three-month period compared to the prior year is primarily driven by both an increase in expenses and a decrease in revenue. Higher expenses were driven by an increase in research and development expenses due to clinical and manufacturing activities and an increase in personnel expenses to support expanded development activities. Revenue to date has primarily been related to license and collaboration agreements entered into during 2009, 2010, and 2011. The decrease in revenue was primarily due to an increase in revenue in the first quarter of 2018 from the portion of a $30 million milestone from KHK that related to the period of time from execution of the KHK agreement until the three months ended March 31, 2018. There was no such catch-up revenue recognition in the first quarter of 2019.

Our cash-based operating expenses, a non-GAAP measure, were $31.9 million for the three months ended March 31, 2019. This compares to $25.6 million for the same period in 2018. We expect our cash-based operating expenses to continue to increase in the future as we advance bardoxolone and omaveloxolone through ongoing and future clinical trials, scale manufacturing for registrational and validation purposes, advance other product candidates into mid- and later-stage clinical trials, expand our product candidate portfolio, increase both our research and development and administrative personnel, and plan for commercialization of our product candidates.

At March 31, 2019, we had $313.1 million in cash and cash equivalents. We expect our current cash to fund our operations through data readouts for CARDINAL, MOXIe, and CATALYST.

Non-GAAP Financial Measures

In addition to the U.S. generally accepted accounting principles (GAAP) financial highlights, this earnings release includes cash-based operating expenses, a non-GAAP financial measure, which the Company defines as total expenses excluding stock-based compensation expense and depreciation expense. A reconciliation of this non-GAAP financial measure to its most directly comparable GAAP financial measure is presented in the table below in this earnings release.

We believe that this non-GAAP financial measure, in addition to GAAP financial measures, provides a meaningful measure of our ongoing business and operating performance by allowing investors to analyze our financial results similarly to how management analyzes our financial results by viewing period expense totals more indicative of effort directly expended to advance the business and our product candidates. Non-GAAP financial measures should be considered in addition to, not in isolation or as a substitute for, GAAP financial measures. In addition, our non-GAAP financial measure may differ from similarly named measures used by other companies.

CONFERENCE CALL INFORMATION

Date: Thursday, May 9, 2019
Time: 8:00 a.m. ET
Audience Dial-in (toll-free): 844-348-3946
Audience Dial-in (international): 213-358-0892
Conference ID: 5177169
Webcast Link: View Source

On May 9, 2019 argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, reported financial results and provided a business update for the first quarter ended March 31, 2019 (Press release, argenx, MAY 9, 2019, View Source [SID1234536080]).

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"During the first quarter, we advanced our broad clinical development plan of efgartigimod across four autoimmune indications in both our IV and subcutaneous formulations. Enrollment of our Phase 3 ADAPT clinical trial in generalized myasthenia gravis is on track, and we intend to launch a second Phase 3 program in primary immune thrombocytopenia in the second half of 2019 that will encompass both formulations. There remains a gap in autoimmune disease innovation for therapies that are specific and well-tolerated, and it is this need that drives us in our goal to deliver our FcRn antagonist to patients quickly," commented Tim Van Hauwermeiren, chief executive officer of argenx. "We also closed on our global collaboration with Janssen this quarter, receiving $500 million in upfront payments, to evaluate cusatuzumab for acute myeloid leukemia, myelodysplastic syndromes and other potential hematological indications."

"We look forward to our upcoming R&D Day where we will showcase our formula for translating immunology breakthroughs into first-in-class medicines and unveil two new antibody assets in our wholly-owned pipeline."

FIRST QUARTER 2019 AND RECENT HIGHLIGHTS

Pipeline Updates:

Efgartigimod (ARGX-113) Program

Phase 3 ADAPT clinical trial, including one-year open-label extension study, is ongoing for treatment of generalized myasthenia gravis with topline data expected in 2020.

argenx on track to launch global development program in primary immune thrombocytopenia (ITP) in second half 2019; update expected to be provided in third quarter 2019 on development strategy and regulatory feedback, including planned registration path and plan to bridge between intravenous (IV) and subcutaneous (SC) formulations.

Orphan drug designation granted in February 2019 by U.S. Food and Drug Administration (FDA) for treatment of primary ITP.

Ongoing open-label extension study from completed Phase 2 proof-of-concept clinical trial in ITP expected to close in mid-2019 in preparation for start of Phase 3 development program.

Phase 2 proof-of-concept clinical trial ongoing for treatment of pemphigus vulgaris; data expected in 2020.

Phase 2 clinical trial for treatment of chronic inflammatory demyelinating polyneuropathy expected to start in second half of 2019.

Phase 1 clinical trial in healthy volunteers planned with ENHANZE SC formulation of efgartigimod as part of collaboration with Halozyme announced in February 2019; data expected before end of 2019.

Collaboration provides argenx access to ENHANZE subcutaneous delivery technology for up to three targets, including exclusive rights to develop therapeutic products targeting human neonatal Fc receptor FcRn.

Upfront payment of $30 million paid to Halozyme with potential future payments up to $160 million per selected target subject to achievement of specified development, regulatory and sales-based milestones.

Cusatuzumab (ARGX-110) Program

Announced closing of exclusive global collaboration and license agreement with Janssen for cusatuzumab.

Received $300 million upfront cash payment, and Johnson & Johnson Innovation made equity investment of €176.7 million ($200.0 million based on exchange rate on date of signing) in argenx.

argenx retains right to co-promote cusatuzumab in United States and share such royalties with Janssen on 50-50 basis.

Orphan drug designation granted by FDA in January 2019 for treatment of acute myeloid leukemia.
Received first clinical milestone payment of $30 million for initiation of first-in-human clinical trial with antibody product candidate ABBV-151 (ARGX-115) as part of option agreement with AbbVie.

Corporate Updates

Torsten Dreier will resign from his function as chief development officer of argenx to focus on new role as chief development officer of AgomAb, a company founded through collaboration with argenx to advance ARGX-114, an HFG-mimetic SIMPLE Antibody directed against the MET receptor. Mr. Dreier will continue to serve as a consultant to argenx.

argenx Japan KK is being established as a wholly-owned subsidiary, and Hermann Strenger was appointed as General Manager of argenx Japan. In this role, Mr. Strenger will be responsible for all aspects of early commercial planning for efgartigimod in Japan. He has served in executive positions in the pharmaceutical industry in Japan for the last 23 years.

argenx R&D Day

argenx to host its second R&D Day on Thursday, May 22, 2019, to present new pipeline programs
ARGX-117 and ARGX-118.

Details of Financial Results

Cash, cash equivalents and current financial assets totaled €961.6 million on March 31, 2019, compared to €564.6 million on December 31, 2018 and €346.6 million on March 31, 2018. The increase in the cash balance on March 31, 2019 resulted primarily from the closing of the exclusive global collaboration and license agreement for cusatuzumab with Janssen triggering a $300 million upfront payment and a $200 million equity investment in January 2019.

Operating income increased by €33.1 million for the three months ended March 31, 2019 to reach €40.0 million, compared to €6.9 million for the three months ended March 31, 2018. The increase of €30.9 million in revenue was primarily related to the recognition of a $30.0 million development milestone under the AbbVie collaboration agreement and the partial recognition of the upfront payment received under the Janssen collaboration agreement. Other operating income increased by €2.2 million, resulting mainly from an increase in payroll tax rebates for employing certain research and development personnel.

Research and development expenses increased by €19.6 million for the three months ended March 31, 2019 to €34.8 million, compared to €15.1 million for the three months ended March 31, 2018. The increase in 2019 resulted primarily from (i) an increase of €11.1 million in external research and development expenses, reflecting higher clinical trials costs and manufacturing expenses related to the development of the late-stage argenx product candidate portfolio, (ii) an increase of €4.3 million in license fee costs payable to one of argenx’ licensors following the achievement of a development milestone under the AbbVie collaboration agreement and (iii) a €2.6 million increase in share-based compensation expenses linked to the grant of stock options to its research and development employees.

Selling, general and administrative expenses totaled €11.3 million and €5.9 million for the three months ended March 31, 2019 and 2018, respectively. The increase of €5.4 million in selling, general and administrative expenses for the three months ended March 31, 2019 primarily resulted from (i) an increase of €2.1 million in share-based compensation expenses linked to the grant of stock options to its selling, general and administrative employees and board members and (ii) higher personnel expenses and consulting fees related to the preparation of potential future commercialization of the lead product candidate efgartigimod.

For the three months ended March 31, 2019, financial income amounted to €3.5 million, compared to €0.5 million for the three months ended March 31, 2018. The increase of €3.0 million in 2019 related primarily to an increase in the interest received on cash, cash equivalents and current financial assets.

Exchange gains totaled €9.5 million for the three months ended March 31, 2019, compared to the €4.0 million exchange losses incurred for the three months ended March 31, 2018. The increase was mainly attributable to unrealized exchange rate gains on the cash, cash equivalents and current financial assets position in U.S. dollars due to the favorable fluctuation of the EUR/USD exchange rate in the first three months of 2019.

The company generated a total comprehensive profit of €6.7 million for the three months ended March 31, 2019, compared to a total comprehensive loss of €17.7 million for the three months ended March 31, 2018. The total comprehensive profit in the first quarter of 2019 mainly resulted from the recognition of a $30.0 million development milestone under the AbbVie collaboration agreement and the unrealized exchange rate gains accounted during the period.

EXPECTED 2019 FINANCIAL CALENDAR:

August 1, 2019: HY 2019 business update and financial results

October 24, 2019: Q3 2019 business update and financial results