Uncategorized – Page 15334 – 1stOncology™: Cancer Intelligence Service

Geron to Announce Third Quarter 2018 Financial Results on November 1, 2018

On October 25, 2018 Geron Corporation (Nasdaq: GERN) reported that it will release its third quarter 2018 financial results after the market closes on Thursday, November 1, 2018 (Press release, Geron, OCT 25, 2018, View Source [SID1234530148]). The financial press release will be available on the Company’s website at www.geron.com/investors. Geron will host a conference call to discuss the third quarter results and recent events at 4:30 p.m. ET the same day.

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Participants may access the conference call live via telephone by dialing domestically +1 (877) 303-9139 or internationally +1 (760) 536-5195. The passcode is 7133129. Participants are advised to dial in at least 10 minutes prior to minimize any delay in joining the call. A live, listen-only webcast will also be available on the Company’s website at www.geron.com/investors/events. If you are unable to listen to the live call, an archived webcast will be available on the Company’s website for 30 days.

Seattle Genetics Announces Multiple Data Presentations Evaluating ADCETRIS® (Brentuximab Vedotin) in Patients with Hodgkin Lymphoma at ISHL 2018

On October 25, 2018 Seattle Genetics, Inc. (Nasdaq:SGEN) reorted that highlighted multiple presentations evaluating ADCETRIS (brentuximab vedotin) across a broad range of Hodgkin lymphoma (HL) settings at the 11th International Symposium on Hodgkin Lymphoma (ISHL) taking place in Cologne, Germany, October 27-29, 2018 (Press release, Seattle Genetics, OCT 25, 2018, View Source [SID1234530190]). Data include both encore and additional analyses from the phase 3 ECHELON-1 clinical trial evaluating ADCETRIS in combination with chemotherapy in frontline Stage III or IV classical HL adult patients, which formed the basis of U.S. Food and Drug Administration (FDA) approval in this indication in March 2018. Interim results will be presented from two ongoing clinical trials evaluating ADCETRIS in combination with Opdivo (nivolumab), including in newly diagnosed older HL patients. Lastly, five-year follow-up from the phase 3 AETHERA clinical trial will be presented. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL that plays a role in tumor pathogenesis. ADCETRIS is being evaluated globally as the foundation of therapy for HL in more than 50 ongoing clinical trials. ADCETRIS and Opdivo are not approved in combination for the treatment of HL.

"After more than a decade of dedicated clinical research with ADCETRIS, we have made significant progress in improving the treatment outcomes for patients with Hodgkin lymphoma," said Nancy Whiting, Pharm.D., Senior Vice President, Clinical Development and Global Medical Affairs at Seattle Genetics. "At ISHL, we will present additional analyses from the ECHELON-1 trial, which demonstrated that ADCETRIS plus AVD improves upon a frontline standard of care regimen, ABVD, in advanced patients and resulted in the first change in advanced stage HL in over 40 years. In addition, three oral presentations will highlight ADCETRIS plus Opdivo combination data in frontline and relapsed/refractory HL and five-year data from the phase 3 AETHERA trial. We are pleased to share these results from our broad ADCETRIS clinical development program with the Hodgkin lymphoma community."

Multiple corporate presentations will be presented at ISHL. Abstracts will be available at www.hodgkinsymposium.org.

Data from four analyses of the phase 3 ECHELON-1 clinical trial will be presented at ISHL. Importantly, an analysis from the ECHELON-1 study (Abstract #0038) will be presented in an oral presentation and poster showing PFS data per investigator that is consistent with the previously reported modified PFS data per Independent Review Facility (IRF). The ECHELON-1 abstracts include the following:

Frontline brentuximab vedotin plus chemotherapy exhibits superior modified progression-free survival vs chemotherapy alone in patients with stage III or IV Hodgkin lymphoma: phase 3 ECHELON-1 study (Abstract #0038, oral presentation and poster on Monday, October 29 at 07:30-07:50 CEST)
Population pharmacokinetic modeling and exposure-response assessment of brentuximab vedotin efficacy and safety in patients with advanced classical Hodgkin lymphoma from the phase 3 ECHELON-1 study (Abstract #0137, poster presentation)
Serum sCD30 and TARC do not correlate with PET-based response assessment in patients (pts) with stage III or IV classical Hodgkin lymphoma (cHL): phase 3 ECHELON-1 study of brentuximab vedotin plus chemotherapy vs chemotherapy alone (Abstract #0159, poster presentation)
Brentuximab vedotin plus chemotherapy in high risk advanced-stage classical Hodgkin lymphoma (cHL) patients: Results of pre-specified sub-group analyses from the ECHELON-1 study (Abstract #0136, poster presentation)
Additional data presentations at ISHL include the following:

Brentuximab Vedotin in Combination with Nivolumab in Patients with Relapsed or Refractory Hodgkin Lymphoma: Follow-up Results from the Phase 1/2 Study (Abstract #0005, oral presentation on Monday, October 29 at 14:40-14:50 CEST)

Data will be reported from 62 patients with relapsed or refractory HL who received the combination regimen of ADCETRIS plus Opdivo after failure of frontline therapy. Patients were treated once every three weeks, with up to four cycles of combination therapy in the outpatient setting. After completion of the fourth cycle of treatment, patients were eligible to undergo an autologous stem cell transplant (ASCT). The median age of patients was 37 years. The majority of patients (95 percent) were refractory or had relapsed after receiving the standard of care frontline treatment ABVD (Adriamycin, bleomycin, vinblastine and dacarbazine) or some variation of the standard of care (ABVE-PC, R-ABVD). Key findings will be presented in an oral presentation by Alex Herrera, M.D., Assistant Professor at the City of Hope Medical Center, Duarte, CA and include:

Of 61 response-evaluable patients, 49 patients (80 percent) had an objective response, including 37 patients (61 percent) with a complete response and 12 patients (20 percent) with a partial response.
Of the 61 response-evaluable patients, the estimated 21-month overall survival (OS) and PFS were 95 percent and 82 percent, respectively. The median follow-up time was 21.8 months and both median OS and PFS were not yet reached. Of 42 patients who underwent ASCT directly after treatment with ADCETRIS plus Opdivo, estimated PFS at 21-months was 97 percent and median PFS was not yet reached.
PFS was evaluated by response to treatment. The estimated PFS at 21-months for patients with a complete response was 97 percent, for patients with a partial response was 83 percent and patients with stable disease was 50 percent.
As previously reported, the most common adverse events (AEs) of any grade occurring prior to ASCT or subsequent salvage therapy in at least 20 percent of patients were nausea, infusion-related reaction (IRR), fatigue, pruritus, diarrhea, headache, vomiting, cough, pyrexia, dyspnea and nasal congestion.
Phase 2 Study of Frontline Brentuximab Vedotin Plus Nivolumab in Patients with Hodgkin Lymphoma Aged ≥60 Years (Abstract #0153, oral presentation on Monday, October 29 at 15:05-15:15 CEST)

Interim results will be presented from an ongoing phase 2 clinical trial evaluating ADCETRIS in combination with Opdivo as frontline therapy for HL patients age 60 years or older. ADCETRIS combination data were reported from 14 patients. The median age of patients was 71.5 years. The majority of patients (79 percent) had stage III/IV disease at the time of diagnosis. The interim results will be highlighted in an oral presentation by Jonathan Friedberg, M.D., Director of the University of Rochester Medical Center, NY and include:

Of 11 response-evaluable patients with a median follow-up time of eight months, nine patients (82 percent) had an objective response, including six patients (55 percent) with a complete response and three patients (27 percent) with a partial response. In addition, two patients (18 percent) had stable disease which equates to all 11 patients (100 percent) experiencing disease control (complete response + partial response + stable disease) as a result of treatment with ADCETRIS in combination with Opdivo.
The most common AEs of any grade occurring in at least 25 percent of patients were fatigue, diarrhea, constipation, nausea, arthralgia, chills, decreased appetite, pyrexia, IRR, aspartate aminotransferase increased and peripheral sensory neuropathy. Grade 3 or higher adverse events occurred in seven patients (50 percent), and the most common were peripheral neuropathy and lipase increased (three patients each); nausea and alanine aminotransferase increased (two patients each).
Five patients (36 percent) had IRRs, with the majority of symptoms at Grade 1 and there were no Grade 3 or higher symptoms. Four patients (29 percent) were treated with corticosteroid and no patients discontinued treatment due to an IRR.
Five-Year Progression-Free Survival Outcomes from a Pivotal Phase 3 Study of Consolidative Brentuximab Vedotin after Autologous Stem-Cell Transplantation (ASCT) in Patients with Hodgkin Lymphoma at Risk of Relapse or Progression (AETHERA) (Abstract #0110, oral presentation on Monday, October 29 at 17:10-17:20 CEST)

The phase 3 AETHERA clinical trial was designed to evaluate the potential of single-agent ADCETRIS to extend PFS post-ASCT in patients with classical HL who were at high risk of relapse or progression. ADCETRIS was approved by the FDA in August 2015 for the treatment of adult patients with classical HL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation. The five-year follow-up efficacy and safety data will be highlighted in an oral presentation by Craig Moskowitz, M.D., Physician in Chief, Sylvester Comprehensive Cancer Center, University of Miami and include:

The five-year PFS rate per investigator was 59 percent in the ADCETRIS arm compared to 41 percent in the placebo arm. Median PFS per investigator was not yet reached in the ADCETRIS arm versus 15.8 months in the placebo arm. The hazard ratio was 0.521 indicating a 48 percent reduction in the risk of progression or death with treatment of ADCETRIS compared to placebo.
Fewer patients in the ADCETRIS arm of the study received subsequent anti-cancer therapies versus the placebo arm (32 percent versus 54 percent, respectively). In addition, fewer patients in the ADCETRIS arm received allogeneic stem-cell transplants versus the placebo arm (17 patients versus 31 patients).
A PFS analysis evaluating subgroups included patients in the ADCETRIS arm with either two or more or three or more risk factors, showed patients with a greater number of risk factors for relapse post-ASCT appeared to have the greatest benefit from ADCETRIS consolidation therapy. In both subgroups evaluating either two or more or three or more risk factors, median PFS was not reached in the ADCETRIS arm and was 9.7 months and 6.3 months, respectively, in the placebo arm.
In the ADCETRIS arm, 112 patients (67 percent) reported peripheral neuropathy. To date, 90 percent of these patients had resolution or improvement in symptoms, with 73 percent having complete resolution.
About Classical Hodgkin Lymphoma

Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Classical Hodgkin lymphoma is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell. The Reed-Sternberg cell expresses CD30.

According to the American Cancer Society, approximately 8,500 cases of Hodgkin lymphoma will be diagnosed in the United States during 2018 and more than 1,000 will die from the disease. Approximately half of all newly diagnosed Hodgkin lymphoma patients have Stage III/IV disease. According to the Lymphoma Coalition, over 62,000 people worldwide are diagnosed with Hodgkin lymphoma each year and approximately 25,000 people die each year from this cancer.

About ADCETRIS (brentuximab vedotin)

ADCETRIS is being evaluated broadly in more than 70 clinical trials in CD30-expressing lymphomas. These include the recently completed phase 3 ECHELON-2 trial in frontline peripheral T-cell lymphomas (also known as mature T-cell lymphoma), the completed phase 3 ECHELON-1 trial in previously untreated Hodgkin lymphoma, the completed phase 3 ALCANZA trial in cutaneous T-cell lymphoma, and the ongoing CHECKMATE 812 trial of ADCETRIS in combination with Opdivo (nivolumab) for relapsed/refractory Hodgkin lymphoma.

ADCETRIS is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.

ADCETRIS injection for intravenous infusion has received FDA approval for five indications in adult patients with: (1) previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with chemotherapy, (2) cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation, (3) cHL after failure of auto-HSCT or failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (4) sALCL after failure of at least one prior multi-agent chemotherapy regimen, and (5) primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.

Health Canada granted ADCETRIS approval with conditions for relapsed or refractory Hodgkin lymphoma and sALCL in 2013, and non-conditional approval for post-autologous stem cell transplantation (ASCT) consolidation treatment of Hodgkin lymphoma patients at increased risk of relapse or progression.

ADCETRIS received conditional marketing authorization from the European Commission in October 2012. The approved indications in Europe are: (1) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following ASCT, or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, (2) the treatment of adult patients with relapsed or refractory sALCL, (3) for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT, and (4) for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

ADCETRIS has received marketing authorization by regulatory authorities in 71 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See select important safety information, including Boxed Warning, below.

Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.

Horizon Pharma plc to Participate in Investor Conferences in November

On October 25, 2018 Horizon Pharma plc (Nasdaq: HZNP) reported that the company will participate in the following conferences in November (Press release, Horizon Pharma, OCT 25, 2018, View Source [SID1234530135]):

Stifel 2018 Healthcare Conference

Date: Wednesday, Nov. 14, 2018
Presentation Time: 10:15 a.m. EST
Location: New York, NY
Jefferies 2018 London Healthcare Conference

Date: Thursday, Nov. 15, 2018
Presentation Time: 10 a.m. GMT
Location: London, United Kingdom
The presentations will be webcast live and may be accessed by visiting Horizon’s website at View Source A replay of the webcast will be available for each event.

Sitka Biopharma Announces New Investment from Global Health Sciences Fund

On October 25, 2018 Sitka Biopharma reported that Quark Venture Inc. and GF Securities, through their Global Health Sciences Fund (GHS), has invested $1.9M into Sitka – financing that will enable the company to complete critical GLP toxicology studies and GMP manufacture of clinical drug product (Press release, Sitka Biopharma, OCT 25, 2018, View Source [SID1234530250]). This in turn will allow Sitka and partner Cancer Research UK (CRUK) to complete initial Phase 1 clinical trials of STK-01, Sitka’s lead product for the treatment of bladder cancer.

A spin-off of CDRD and the University of British Columbia (UBC), Sitka Biopharma is a preclinical biotechnology company focused on developing its breakthrough nanoparticle platform technology to increase absorption of drugs in difficult-to-penetrate tissues. While STK-01 is being developed for the treatment of bladder cancer, follow-on indications of the current core formulation include intraperitoneal delivery for ovarian cancer and other indications where localized drug delivery would be advantageous but currently ineffective due to those penetration challenges.

Preclinical studies have established that Sitka’s candidate formulation significantly improved bladder tissue uptake when compared to the commercial docetaxel formulation. Furthermore, the proprietary hyperbranched polyglycerols (HPG)-docetaxel formulation demonstrated superior efficacy over commercial docetaxel – providing a preclinical proof-of-concept.

Dr. Michael Parr, Sitka’s President and Chief Scientific Officer said, "This is an extremely pivotal investment for Sitka as it means we can complete the final IND-enabling studies and take our lead therapeutic for bladder cancer into the clinic via our partnership with CRUK. This investment sets up the company for rapid progression through those initial clinical trials and we can also begin planning to expand STK-01 to additional indications."

Ms. Karimah Es Sabar, Chief Executive Officer of Quark Venture and Director of GHS Fund commented "GHS Fund believes Sitka is poised for an important medical breakthrough in bladder cancer. This initial success will be leveraged for further development of the platform in other indications, including ovarian cancer."

Bladder cancer is the 4th most common cancer in men, and has the highest per patient lifetime cost of all cancers. The challenge in bladder cancer is that because of the nature of the bladder, drugs are not well-absorbed and only stay in the bladder for as long as the patient does not void their bladder – a critical issue addressed by the Sitka technology.

This technology was initially developed through a collaboration between the UBC and CDRD. Additional early funding included grants from the Canadian Institutes of Health Research (CIHR), Genome British Columbia, and the National Research Council of Canada’s IRAP Program. Quark Venture provided the first private financing in March 2016

argenx reports third quarter 2018 financial results and provides business update

On October 25, 2018 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 third quarter ended September 30, 2018 (Press release, argenx, OCT 25, 2018, View Source [SID1234530147]).

"The proof-of-concept data that we have generated in the last year from our Phase 2 clinical trials in generalized myasthenia gravis (gMG), immune thrombocytopenia (ITP) and pemphigus vulgaris (PV) support efgartigimod’s (ARGX-113) potential in severe autoimmune disease, and we are committed to advancing and expanding this clinical program as quickly as possible. We continue to see potential differentiation of our molecule among the anti-FcRn class of therapies in terms of tolerability, improvement in disease scores, and stage of development. We are now evaluating our lead candidate in four indications, two formulations to accommodate tailored therapy, and in one registration trial with another expected to launch next year," commented Tim Van Hauwermeiren, CEO of argenx. "Our second program, cusatuzumab (ARGX-110), will follow quickly as we enroll newly diagnosed, elderly acute myeloid leukemia (AML) patients in a Phase 2 clinical trial. We plan to show the full Phase 1 data in December during our annual American Society of Hematology (ASH) (Free ASH Whitepaper) workshop, along with the full dataset from the Phase 2 clinical trial of efgartigimod in ITP."

"We believe we have differentiated antibody design capabilities and continue to show this through reproducible value creation with the robust clinical datasets from our wholly-owned programs, successes from our collaborations including the in-licensing by AbbVie of ARGX-115, and the pipeline we grow using novel targets from esteemed academic institutions."

THIRD QUARTER 2018 AND RECENT HIGHLIGHTS:

Pipeline Updates:

Efgartigimod (ARGX-113):

Reported positive topline results from Phase 2 proof-of-concept trial of intravenous (IV) efgartigimod in primary ITP:

Well-tolerated, consistent with efgartigimod clinical trials to-date.

Clinically meaningful platelet count improvements seen across doses and ITP patient classifications, correlating with consistent reduction in Immunoglobulin G levels.

Showed separation from placebo at increasing response thresholds, with response rates of 46% and 58% in primary trial and first dosing of open-label extension study, respectively.

Announced plans to advance IV efgartigimod into Phase 3 development in ITP in second half of 2019 and subcutaneous efgartigimod into Phase 2 trial in ITP in first half of 2019.

Dosed first patient in global Phase 3 registration trial of efgartigimod in patients with gMG.

Phase 3 trial, if results are positive, expected to serve as basis to submit Biologics License Application (BLA) in U.S. and for marketing authorization in Japan, based on feedback from U.S. Food and Drug Administration (FDA) and Pharmaceuticals and Medical Devices Agency (PMDA) in Japan.

Data from Phase 2 proof-of-concept trial of efgartigimod in PV on track to read out in first half of 2019.

Announced chronic inflammatory demyelinating polyneuropathy (CIDP) as fourth indication for efgartigimod with Phase 2 proof-of-concept trial expected to start in first half of 2019.

Cusatuzumab (ARGX-110):

Enrollment ongoing of initial 21 patients in Phase 2 part of Phase 1/2 proof-of-concept trial of 10 mg/kg cusatuzumab in combination with standard of care azacytidine in newly diagnosed, elderly AML and myelodysplastic syndromes patients who are unfit for chemotherapy.

Corporate Updates:

AbbVie exercised its exclusive option to license ARGX-115, a novel immuno-oncology antibody targeting glycoprotein A repetitions predominant (GARP).

argenx received preclinical milestone in its strategic collaboration with Shire plc. The milestone, for which an undisclosed payment has been received, was triggered by Shire exercising its exclusive option to in-license an antibody discovered and developed using argenx’s proprietary SIMPLE Antibody platform and Fc engineering technologies.

FINANCIAL HIGHLIGHTS (as of September 30, 2018) (compared to financial highlights as of September 30, 2017)

Raised approximately $300.6 million in gross proceeds in U.S. public offering from sale of 3,475,000 American Depositary Shares (ADSs) at a price to the public of $86.50 per ADS; proceeds to be used to advance efgartigimod program in ITP, launch efgartigimod program in CIDP, further scale up manufacturing in advance of potential commercial operations, and expand argenx organization.

Operating income of €24.5 million (September 30, 2017: €30.5 million).

Total comprehensive loss of €36.5 million (September 30, 2017: €16.5 million).

Cash position of €582.3 million (cash, cash-equivalents and current financial assets) allowing argenx to pursue development of its pipeline in severe autoimmune diseases and cancer (September 30, 2017: €161.7 million).

UPCOMING CLINICAL MILESTONES

Present full dataset from Phase 2 proof-of-concept trial of efgartigimod in ITP at workshop around ASH (Free ASH Whitepaper) Annual Meeting (San Diego, December 3, 2018).

Report full data from Phase 1 dose-escalation trial of cusatuzumab in AML at workshop around ASH (Free ASH Whitepaper).

Report full data from Phase 2 proof-of-concept trial of efgartigimod in PV in first half of 2019.

Launch Phase 2 clinical trial in ITP using subcutaneous formulation of efgartigimod in first half of 2019.

Launch Phase 2 clinical trial of efgartigimod in CIDP in first half of 2019.

Q3 2018 FINANCIAL RESULTS:

Nine months ended

September 30,

Adjustments

September 30,

2018

Adoption

2018

2017

(in thousands of €)

IAS 18

IFRS 15 (*)

IFRS 15

IAS 18

Variance

Revenue

17,892

2,031

19,924

28,422

(8,498)

Other operating income

4,594

2,090

2,504

Total operating income

22,487

2,031

24,518

30,512

(5,994)

Research and development expenses

(53,352)

(198)

(53,550)

(36,655)

(16,895)

Selling, general and administrative expenses

(18,245)

(7,339)

(10,906)

Operating loss

(49,111)

1,833

(47,278)

(13,482)

(33,796)

Financial income

1,983

1,895

Exchange gains/(losses)

8,826

(2,476)

11,302

Loss before taxes

(38,301)

1,833

(36,468)

(15,870)

(20,598)

Income tax benefit/(expense)

(597)

629

Loss for the period and total comprehensive loss

(38,269)

1,833

(36,436)

(16,467)

(19,969)

Net increase in cash, cash-equivalents and current financial assets compared to year-end 2017 and 2016

222,506

64,989

Cash, cash-equivalents and current financial assets at the end of the period

582,281

161,717

(*) The company has adopted IFRS 15 on January 1, 2018 using a modified retrospective approach. The impact of adopting IFRS 15 amounts to €1.8 million for the nine months ended September 30, 2018.

Total operating income was €24.5 million for the nine months ended September 30, 2018, compared to €30.5 million for the nine months ended September 30, 2017. The decrease in operating income in 2018 was due to a decrease of €8.5 million in revenue primarily related to the completion of the preclinical activities under the ongoing collaborations with LEO Pharma and AbbVie. The decrease in revenue was partially offset by an increase of €2.5 million in other operating income, mainly driven by an increase in payroll tax rebates for employing certain research and development personnel and higher grant income following the approval of two VLAIO grants in 2018.

Research and development expenses were €53.6 million for the nine months ended September 30, 2018, compared to €36.7 million for the nine months ended September 30, 2017. The increase in research and development expenses in 2018 was principally due to (i) an increase of €11.2 million in costs related to the advancement of the clinical development and manufacturing activities of argenx’s product candidates efgartigimod (notably with the start of a Phase 3 registration trial in efgartigimod), cusatuzumab and ARGX-117 and (ii) an increase of €6.2 million in share-based compensation expenses linked to the grant of stock options to the Company’s research and development employees (including an increase of €1.0 million in social security costs on stock options granted to certain Belgian and non-Belgian resident employees). argenx employed 89 employees and consultants in its research and development functions on September 30, 2018, compared to 71 employees and consultants on September 30, 2017.

Selling, general and administrative expenses were €18.2 million for the nine months ended September 30, 2018, compared to €7.3 million for the nine months ended September 30, 2017. The increase in selling, general and administrative expenses in 2018 is mainly explained by an increase of €9.6 million of personnel expenses resulting primarily from an increase of €7.5 million in share-based compensation expenses linked to the grant of stock options to argenx’s selling, general and administrative employees (including an increase of €1.3 million in social security costs on stock options granted to certain Belgian and non-Belgian resident employees). argenx employed 31 employees and consultants in its selling, general and administration functions on September 30, 2018, compared to 19 employees and consultants on September 30, 2017.

Financial income and exchange gains amounted to €10.8 million for the nine months ended September 30, 2018, compared to financial income and exchange losses of €2.4 million for the nine months ended September 30, 2017, which was primarily attributable to €8.8 million of unrealized exchange rate gains on the Company’s cash, cash equivalents and current financial assets position in USD linked to the favorable fluctuation of the USD exchange rate in the nine months ended September 30, 2018.

argenx generated a loss for the period and total comprehensive loss of €36.5 million for the nine months ended September 30, 2018, compared to a loss for the period and total comprehensive loss of €16.5 million for the nine months ended September 30, 2017.

On September 30, 2018, argenx’s cash, cash equivalents and current financial assets amounted to €582.3 million, compared to €359.8 million on December 31, 2017. The significant increase in its cash balance on September 30, 2018 resulted from the follow-on U.S. public offering of ADSs on the Nasdaq Global Select Market completed in September 2018.

EXPECTED 2019 FINANCIAL CALENDAR:

February 28, 2019: FY 2018 business update and financial results

May 9, 2019: Q1 2019 business update and financial results

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

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

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Category: Uncategorized

Geron to Announce Third Quarter 2018 Financial Results on November 1, 2018

Seattle Genetics Announces Multiple Data Presentations Evaluating ADCETRIS® (Brentuximab Vedotin) in Patients with Hodgkin Lymphoma at ISHL 2018

Horizon Pharma plc to Participate in Investor Conferences in November

Sitka Biopharma Announces New Investment from Global Health Sciences Fund

argenx reports third quarter 2018 financial results and provides business update