On May 9, 2018 Inovio Pharmaceuticals, Inc. (NASDAQ:INO), a late-stage biotechnology company focused on the discovery, development, and commercialization of DNA immunotherapies targeted against cancers and infectious diseases, reported financial results for the first quarter ended March 31, 2018, along with a general business update (Press release, Inovio, MAY 9, 2018, View Source [SID1234526373]).

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Inovio Highlights

VGX-3100. A total of 60 sites globally are open and recruiting for REVEAL 1 (Phase 3 clinical trial for treating cervical dysplasia (CIN) caused by human papillomavirus (HPV)); recruiting patients in Phase 2 study for treating vulvar dysplasia (VIN) and associated diseases.
MEDI0457 in combination with durvalumab advanced to the Phase 2 efficacy stage of the trial, triggering a milestone payment to Inovio. MedImmune is evaluating MEDI0457 in combination with durvalumab, its PD-L1 checkpoint inhibitor, in patients with recurrent/metastatic HPV-associated HNSCC in a clinical trial with an estimated total enrollment of 50 patients.
INO-5401. Opening sites for Phase 1/2a study to evaluate the safety, immunogenicity and preliminary clinical efficacy of INO-5401 and INO-9012 in combination with Roche/Genentech’s atezolizumab in participants with locally advanced unresectable or metastatic/recurrent urothelial carcinoma (UCa); opening sites for Phase 1/2 study to evaluate safety, immunogenicity and preliminary efficacy of INO-5401 and INO-9012 in combination with Regeneron’s cemiplimab in participants with newly-diagnosed glioblastoma (GBM).
INO-1800. Inovio’s treatment for hepatitis B infection is being evaluated in a Phase 1 clinical study in which it has generated virus-specific T cells with a favorable safety profile to date. Inovio continues its partnering discussions and plans to report additional data from this trial at upcoming scientific conferences and in a publication in 2018.
Executed collaboration and partnering agreement with ApolloBio. Inovio received an upfront payment of $23 million (approximately $19.4 million after payment of required taxes) from ApolloBio, which gained the rights to develop, manufacture and commercialize VGX-3100 to treat precancers caused by HPV, within Greater China.
Entered into a clinical collaboration agreement with the Parker Institute for Cancer Immunotherapy. The agreement provides that Inovio and the Parker Institute will undertake clinical evaluation of novel combination regimens within the field of immuno-oncology. Under the agreement, the Parker Institute will have responsibility for funding and clinical study execution, working in collaboration with its established network. Inovio will provide financial contributions if Inovio’s product(s) studied under the collaboration reaches the initiation of a Phase 3 study.
Established partnership with CEPI (in April). Inovio will develop vaccine candidates against Lassa fever and Middle East Respiratory Syndrome (MERS). The Coalition for Epidemic Preparedness Innovations (CEPI) will directly fund up to $56 million to support Inovio’s pre-clinical and clinical advancement through Phase 2 of INO-4500, its Lassa fever vaccine, and INO-4700, its MERS vaccine, over a five-year period.
GENEOS Therapeutics, Inc. Our wholly-owned subsidiary, GENEOS Therapeutics, Inc., which is developing neoantigen-based personalized cancer therapies, plans to raise capital in 2018 to fund the development of its programs.
Cash Position. As of March 31, 2018, cash and cash equivalents and short-term investments were $112.8 million compared to $127.4 million as of December 31, 2017.
Dr. J. Joseph Kim, Inovio’s President & CEO said, "During the first quarter of 2018, Inovio has made significant progress in its clinical trials, while continuing to secure corporate partnerships and obtain significant non-dilutive funding. These accomplishments further validate our proprietary ASPIRE technology targeting cancer and emerging infectious diseases in addition to positioning us as a global leader for treating a wide spectrum of HPV-related diseases. We look forward to building on our treatment capabilities, while continuing to expand on our partnering successes from the first quarter."

First Quarter 2018 Financial Results

Total revenue was $1.5 million for the three months ended March 31, 2018, compared to $10.4 million for the same period in 2017. Total operating expenses were $34.3 million compared to $32.3 million for the same period in 2017.

As a result of the adoption of Accounting Standards Update No. 2014-09, Revenue from Contracts with Customers, beginning on January 1, 2018, all contributions received from current grant agreements have been recorded as a contra-expense as opposed to revenue on the consolidated statement of operations. For the three months ended March 31, 2018, $2.2 million was recorded as contra-research and development expense which would have been classified as grant revenue in the prior year. Had this change in presentation not occurred, total revenue would have been $3.7 million for the three months ended March 31, 2018, compared to $10.4 million for the same period in 2017. Total operating expenses would have been $36.5 million compared to $32.3 million for the prior year period.

Inovio’s net loss for the quarter ended March 31, 2018 was $32.4 million, or $0.36 per basic and diluted share, compared to $23.1 million, or $0.31 per basic and diluted share, for the quarter ended March 31, 2017.

Revenue

The decrease in comparable revenue and grant agreement recognition for the first quarter 2018 compared to 2017 was primarily due to the prior year revenue recognized from the termination payment received from Roche during the first quarter of 2017 of $4.0 million. The decrease was also due to a decrease in grant funding recognized from our Defense Advanced Research Projects Agency (DARPA) Ebola grant of $4.7 million, partially offset by an increase in grant funding recognized from our Zika virus sub-grant of $1.2 million.

Operating Expenses

Research and development (R&D) expenses for the three months ended March 31, 2018 were $24.6 million compared to $24.5 million for the same period in 2017. The increase in R&D expenses was primarily related to our VGX-3100 clinical trials, activities under our collaboration with MedImmune and an increase in employee headcount to support our clinical trial activities and partnerships. These increases were offset by the $2.2 million contra-research and development expense recorded from grant agreements as discussed above, as well as a decrease in expenses related to the DARPA Ebola grant as it nears completion.

General and administrative (G&A) expenses were $9.7 million for the three months ended March 31, 2018 versus $7.8 million for the same period in 2017. The increase in G&A expenses was primarily related to the Chinese taxes and advisory fees incurred in connection with the ApolloBio upfront payment we received, offset by a decrease in non-cash stock based compensation.

Capital Resources

As of March 31, 2018, cash and cash equivalents and short-term investments were $112.8 million compared to $127.4 million as of December 31, 2017. As of March 31, 2018, the Company had 90.7 million common shares outstanding and 102.3 million common shares outstanding on a fully diluted basis, after giving effect to outstanding options, warrants, restricted stock units and convertible preferred stock.

Inovio’s balance sheet and statement of operations are provided below. Form 10-Q providing the complete 2018 first quarter financial report can be found at: View Source

Conference Call / Webcast Information

Inovio’s management will host a live conference call and webcast at 4:30 p.m. Eastern Time today to discuss Inovio’s financial results and provide a general business update.

The live webcast and a replay may be accessed by visiting the Company’s website at View Source Please connect to the Company’s website at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Telephone replay will be available approximately two hours after the call at 877-481-4010 (domestic) or 919-882-2331 (international) using replay ID 29009.

On May 9, 2018 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported financial results for the first quarter ended March 31, 2018 (Press release, Puma Biotechnology, MAY 9, 2018, View Source [SID1234526389]).

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Unless otherwise stated, all comparisons are for the first quarter 2018 compared to the first quarter 2017.

On July 17, 2017, Puma Biotechnology received approval from the U.S. Food and Drug Administration (FDA) for NERLYNX (neratinib) for the treatment of early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy, and the Company began shipment to wholesalers at the end of July 2017. Prior to the launch of NERLYNX the Company had no product revenue. Net product revenue from sales of NERLYNX in the first quarter of 2018 amounted to $36.0 million, compared to net product revenue of $6.1 million and $20.1 million in the third and fourth quarters of 2017, respectively.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported a net loss applicable to common stock of $24.3 million, or $0.65 per share, for the first quarter of 2018, compared to a net loss applicable to common stock of $72.9 million, or $1.97 per share, for the first quarter of 2017.

Non-GAAP adjusted net income was $1.1 million, or $0.03 per basic share and $0.02 per diluted share, for the first quarter of 2018, compared to non-GAAP adjusted net loss of $43.1 million, or $1.16 per basic and diluted share, for the first quarter of 2017. Non-GAAP adjusted net income (loss) excludes stock-based compensation expense, which represents a significant portion of overall expense and has no impact on the cash position of the Company. For a reconciliation of GAAP net loss to non-GAAP adjusted net income (loss) and GAAP net loss per share to non-GAAP adjusted net income (loss) per share, please see the financial tables at the end of this news release.

Net cash used in operating activities for the first quarter of 2018 was $6.3 million. At March 31, 2018, Puma had cash and cash equivalents of $78.6 million, compared to cash and cash equivalents of $81.7 million at December 31, 2017.

"We made substantial progress in the commercialization of our lead product, NERLYNX (neratinib), during the first quarter of 2018," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "We quickly built momentum in the U.S. market, with net sales steadily rising since our launch. Our exclusive licensing agreements to date, with Pint Pharma in Latin America, CANbridge in mainland China and Taiwan, Medison Pharma in Israel, and Specialised Therapeutics Asia in South East Asia, demonstrate our commitment to also make NERLYNX accessible to patients globally while we continue to grow the U.S. market.

"We are also pleased with the updated National Comprehensive Cancer Network (NCCN) guidelines, which designate NERLYNX as a recommended combination treatment option for breast cancer patients with brain metastases. In addition, data on neratinib were published in the journal Nature, which included initial results from Puma’s ongoing SUMMIT Phase II ‘basket’ clinical trial in patients with tumors harboring HER2 or HER3 mutations. SUMMIT is designed to evaluate the contributions of both genetic mutation and cancer type on individual patient response to neratinib. Information generated from the trial will help guide neratinib-based targeted therapy across a broad spectrum of tumor types with HER2 or HER3 mutations, including patients with rare tumors who may not otherwise have access to investigational therapies. We believe the publication of the initial SUMMIT data in this prestigious journal reflects the novelty and quality of this precision-medicine trial design, as well as the growing understanding that both tumor type and gene mutations play an important role in individual patients’ response to cancer therapies such as neratinib."

Mr. Auerbach added, "During 2018, we anticipate the following key milestones: (i) reporting updated Phase I/II data from neratinib plus Kadcyla (T-DM1) in the HER2-positive metastatic breast cancer trial in the second quarter of 2018; (ii) re-assessment of the Marketing Authorisation Application for neratinib by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in mid-2018; (iii) reporting data from the Phase III trial in third-line metastatic breast cancer patients in the second half of 2018; (iv) submitting for regulatory approval for the extended adjuvant HER2-positive early stage breast cancer indication in select countries in the second half of 2018; and (v) reporting additional data from the Phase II CONTROL trial in the fourth quarter of 2018."

Revenue

Total revenue consists of net product revenue from sales of NERLYNX, Puma’s first and only commercial product to date, and license revenue. The FDA approved NERLYNX for commercial sale in the United States in July 2017 and the Company commenced shipment to wholesalers in late July. For the first quarter of 2018, total revenue was $66.5 million, of which $36.0 million was net product revenue and $30.5 million was license revenue received from Puma’s sub-licensees.

Operating Expenses

Operating expenses were $89.9 million for the first quarter of 2018, compared to $73.2 million for the first quarter of 2017.

Cost of Sales:

Cost of sales was $6.4 million for the first quarter of 2018. The Company had no product sales prior to the third quarter of 2017.

Selling, General and Administrative Expenses:

Selling, general and administrative expenses were $36.6 million for the first quarter of 2018, compared to $18.4 million for the first quarter of 2017. The $18.2 million increase resulted primarily from increases of approximately $7.8 million in payroll and related costs, $6.6 million in marketing, market access, and legal expenses, $1.7 million in travel and related costs, and $1.7 million in stock-based compensation. These increases reflect the commercial launch of NERLYNX and overall corporate growth.

Research and Development Expenses:

Research and development (R&D) expenses were $46.9 million for the first quarter of 2018, compared to $54.8 million for the first quarter of 2017. The $7.9 million decrease resulted primarily from decreases of approximately $6.1 million for stock-based compensation and $4.0 million for clinical trial expenses, partially offset by an increase of $2.2 million for payroll and related costs in medical affairs and commercial quality assurance. For our existing clinical trials, we expect R&D expenses to decrease in subsequent quarters as clinical trials continue to wind down.

Conference Call

Puma Biotechnology will host a conference call to report its first quarter 2018 financial results and provide an update on the company’s business and outlook at 1:30 p.m. PDT/4:30 p.m. EDT on Wednesday, May 9, 2018. The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international) at least 10 minutes prior to the start of the call and referencing the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available approximately one hour after completion of the call and will be archived on the company’s website for 90 days.

On May 9, 2018 Lodo Therapeutics Corporation, a drug discovery and development company focused on identifying and producing unique, bioactive natural products directly from the microbial DNA sequence information contained in soil, reported that it has formed a strategic drug discovery collaboration with Genentech, a member of the Roche Group (Press release, Lodo Therapeutics, MAY 9, 2018, View Source [SID1234526409]).

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Under the terms of the agreement, Genentech will utilize Lodo Therapeutics’ proprietary genome mining and biosynthetic cluster assembly platform to identify novel molecules with therapeutic potential against multiple disease-related targets of interest to Genentech. Lodo will receive an undisclosed upfront payment and is eligible to receive research, development and commercialization milestone payments up to $969 million based on achievement of certain predetermined milestones. In addition, Lodo is eligible to receive tiered-royalties on sales of certain products resulting from the collaboration.

"Lodo Therapeutics’ proprietary drug discovery platform is a powerful engine for identifying novel compounds with important therapeutic potential," said Thong Q. Le, chief executive officer at Lodo Therapeutics and Accelerator Life Science Partners. "We are incredibly excited to work with Genentech, and we look forward to demonstrating the power and utility of Lodo’s unique technology for the benefit of global human health."

Compounds derived from natural products comprise a significant proportion of the small molecule drugs used to treat cancer, infections and chronic illnesses such as Type 2 diabetes. Rather than relying on culturing known strains of bacteria, Lodo Therapeutics’ genome-based approach leverages the power of microbial evolution to identify novel, naturally occurring compounds that have therapeutic potential in the treatment of cancer and drug-resistant bacterial infections. This approach is expected to reduce the time and cost of drug discovery.

"Our ability to enter into a strategic collaboration with one of the leaders in innovating wholly new classes of drugs just two years after Lodo Therapeutics was founded reflects the potential of our proprietary platform to be a valuable resource to advance their drug discovery initiatives," said David Pompliano, Ph.D., co-founder and chief scientific officer of Lodo Therapeutics.

"We are excited to work with Genentech in their quest to discover novel, next-generation natural products derived from the microbiome of the soil using this innovative platform developed by Lodo," said Sean Brady, Ph.D., co-founder of Lodo Therapeutics and Associate Professor at The Rockefeller University. James Sabry, M.D., Ph.D., senior vice president and global head of Genentech Partnering, commented,

"Genentech is committed to accessing innovative technologies and we are excited to collaborate with Lodo Therapeutics to apply their Metagenomics Technology Platform to potentially discover therapeutics for difficult drug targets.

Acorda Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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On May 9, 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 first quarter ended March 31, 2018 (Press release, argenx, MAY 9, 2018, View Source;p=RssLanding&cat=news&id=2347969 [SID1234526297]).

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"We made excellent progress this quarter in executing on our pipeline strategy and are well-prepared for another milestone-rich year ahead in 2018. To start with our lead program efgartigimod (ARGX-113), we presented the full data set from the Phase 2 clinical trial in myasthenia gravis at the American Academy of Neurology (AAN) Annual Meeting showing a reduction in disease scores that correlated with our understanding of the drug candidate’s mechanism. We also made headway in Europe, having received an orphan drug designation in this first indication. We remain on track to report data from two additional indications for efgartigimod, including immune thrombocytopenia and pemphigus vulgaris, in the second half of the year," commented Tim Van Hauwermeiren, CEO of argenx. "The rest of our pipeline is also progressing, including ARGX-110, where we transitioned into the Phase 2 portion of the clinical trial in newly diagnosed AML patients unfit for chemotherapy and expect to report new response data by the end of the year. We continue to look for exciting targets across our research institution partners, and showcased this in the first quarter with the addition of ARGX-117 to our pipeline, offering a new target pathway for argenx and potentially a way to add synergistic value to our efgartigimod pipeline-in-a-product approach."

FIRST QUARTER 2018 AND RECENT HIGHLIGHTS

Presented complete data from Phase 2 clinical trial of efgartigimod (ARGX-113) in generalized myasthenia gravis (MG) at the AAN Annual Meeting.
Announced orphan drug designation for efgartigimod for treatment of MG in Europe.
Initiated Phase 2 part of Phase 1/2 proof-of-concept trial of ARGX-110 (10mg/kg) in combination with azacytidine in newly diagnosed acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS) patients who are unfit for chemotherapy.
Expanded pipeline with the addition of complement-targeted ARGX-117 for the treatment of severe autoimmune diseases. ARGX-117 has potential synergistic effects with our lead autoimmune compound, efgartigimod.
Received third preclinical milestone payment from collaboration with LEO Pharma following approval of a clinical trial application (CTA) filing for ARGX-112.
Announced €2.5 million grant from Flanders Innovation and Entrepreneurship (VLAIO), which will be used to examine the role and therapeutic potential of proteins involved in regulating the localized release of transforming growth factor-beta (TGF-beta).
Appointed R. Keith Woods as Chief Operating Officer.
FINANCIAL HIGHLIGHTS (as of March 31, 2018) (compared to financial highlights as of March 31, 2017)

Operating income of €6.9 million (March 31, 2017: €7.2 million).
Total comprehensive loss of €17.7 million (March 31, 2017: €8.4 million).
Cash position of €346.6 million (cash, cash-equivalents and current financial assets) (March 31, 2017: €85.0 million), allowing us to pursue development of our product candidate portfolio in line with our communicated business plan.
DETAILS OF OPERATIONAL RESULTS

Products in Clinical Development:

Efgartigimod (ARGX-113)

Presented full efficacy data from Phase 2 clinical trial of efgartigimod in generalized MG at the AAN Annual Meeting (April 24, 2018; Los Angeles). The eight-week follow-up phase shows that the administration of efgartigimod resulted in clinical improvement over placebo through the entire duration of the trial (11 weeks). Clinical benefit in the efgartigimod treatment group maximized as of one week after administration of the last dose, achieving statistical significance over the placebo group (p = 0.0356) on the Myasthenia Gravis Activity-of-Daily-Living (MG-ADL) score.
All patients in the treatment arm showed a reduction of total IgG levels. Clinically meaningful disease improvement was found to correlate with a reduction in pathogenic IgG levels.
Total IgG reduction in patients was consistent with the Phase 1 healthy volunteer trial.
Reduction of IgG levels was consistent across IgG subtypes, including AChR autoantibodies (IgG1 and IgG3).
Updated results show mean maximum IgG reduction of up to 70.7% among treated patients.
Completed enrollment in the Phase 2 clinical trial of efgartigimod in immune thrombocytopenia (ITP). Topline data are expected in the second half of 2018.
Received orphan drug designation for the use of efgartigimod for the treatment of MG, from the European Commission (EC), based on the positive opinion of the European Medicines Agency (EMA) adding to the orphan drug designation already granted in the United States.

ARGX-110

Initiated the Phase 2 part of the Phase 1/2 proof-of-concept trial of ARGX-110 in combination with standard of care azacytidine in newly diagnosed, elderly acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS) patients who are unfit for chemotherapy. The Phase 2 part expects to enroll an initial 21 patients and use the selected ARGX-110 dose of 10 m/kg as determined from the dose-escalation part of the study.
Given the potential of ARGX-110 in newly diagnosed AML patients based on early data from the Phase 1/2 proof-of-concept trial, we intend to prioritize the development of ARGX-110 in AML and MDS. We will complete the ongoing Phase 2 trial of ARGX-110 in cutaneous T-cell lymphoma (CTCL), but do not expect to devote resources to its further development in this indication.
Products in Preclinical Development:

ARGX-117

Launched new pipeline candidate, ARGX-117, targeting complement cascade with therapeutic potential in autoantibody-mediated indications. ARGX-117 is a highly differentiated therapeutic antibody product candidate, equipped with the proprietary Fc engineering technology NHance, that addresses a novel target in the complement cascade. With a potentially differentiated mechanism of action, ARGX-117 represents a broad pipeline opportunity across several autoantibody-mediated indications and may have a synergistic effect with lead autoimmune compound, efgartigimod.

Collaborations

Achieved third preclinical milestone from collaboration with LEO Pharma, following approval of clinical trial application (CTA) filing for ARGX-112.
Corporate

Appointed R. Keith Woods as Chief Operating Officer. In this role, Mr. Woods will be responsible for all aspects of early commercial planning for efgartigimod, if approved, including marketing, market access, program management and supply chain operations.
UPCOMING EXPECTED MILESTONES

Report the full data of the Phase 1 healthy volunteer trial with the subcutaneous formulation of ARGX-113 during the second quarter of the year.
Report interim data of the Phase 2 proof-of-concept trial in pemphigus vulgaris and topline data of the Phase 2 proof-of-concept trial for ARGX-113 in ITP in the second half of 2018.
Report the full data of the Phase 2 proof-of-concept trial for ARGX-113 in ITP at the American Society of Haematology (ASH) (Free ASH Whitepaper) Annual Meeting.
Progress ARGX-113 into Phase 3 clinical development in generalized MG before the end of the year.
Report the full data of the AML Phase 1/2 and CTCL Phase 2 clinical trials of ARGX-110 at the ASH (Free ASH Whitepaper) Annual Meeting. (Press release, argenx, MAY 9, 2018, View Source;p=RssLanding&cat=news&id=2347969 [SID1234526297])

The Company has adopted IFRS 15 on January 1, 2018 using a modified retrospective approach. The impact of adopting IFRS 15 amounts to €0.9 million for the three months ended March 31, 2018.

DETAILS OF THE FINANCIAL RESULTS

Operating income reached €6.9 million for the three months ended March 31, 2018, compared to €7.2 million for the three months ended March 31, 2017. The decrease of €1.1 million in revenue resulted primarily from a decrease in revenue recognition linked to the forthcoming completion of the preclinical activities under our ongoing collaboration with LEO Pharma. Other operating income increased by €0.8 million, resulting mainly from (i) an increase in payroll tax rebates for employing certain research and development personnel and (ii) an increase in government grant income following the approval in March 2018 of a €2.5 million VLAIO grant to identify novel therapeutic antibodies.
For the three months ended March 31, 2018, research and development expenses totaled €15.1 million, compared to €12.2 million for the three months ended March 31, 2017. The increase of €2.9 million in research and development expenses in 2018 was principally related to (i) costs associated with a planned increase in research and development headcount and (ii) increased share-based compensation expense linked to the grant of stock options to our research and development employees (including an increase of €1.1 million of social security costs on stock options granted to certain Belgian and non-Belgian resident employees).

Selling, general and administrative expenses amounted to €5.9 million for the three months ended March 31, 2018, compared to €3.4 million for the three months ended March 31, 2017 (which included €1.3 million of expenses related to our U.S. initial public offering in May 2017). The increase in selling, general and administrative expenses in 2018 was principally due to an increase of €3.7 million of personnel expenses resulting from (i) an increase of €3.3 million in share-based compensation expense linked to the grant of stock options to our selling, general and administrative employees (including an increase of €1.5 million of social security costs on stock options granted to certain Belgian and non-Belgian resident employees) and (ii) an increase of €0.4 million for additional employees recruited to strengthen our selling, general and administrative activities.
For the three months ended March 31, 2018, financial income amounted to €0.5 million and related primarily to interest received on our cash, cash equivalents and current financial assets.
Exchange losses totaled €4.0 million on March 31, 2018, compared to €0.01 million on March 31, 2017. This increase is mainly attributable to unrealized exchange rate losses on our cash, cash equivalents and current financial assets position in U.S. dollars due to the unfavorable fluctuation of the EUR/USD exchange rate during the three months ended March 31, 2018.
For the three months ended March 31, 2018, we generated a total comprehensive loss of €17.7 million, compared to a total comprehensive loss of €8.4 million for the three months ended March 31, 2017.
On March 31, 2018, our cash, cash equivalents and current financial assets amounted to €346.6 million, compared to €359.8 million on December 31, 2017 and €85.0 million on March 31, 2017.

EXPECTED 2018 FINANCIAL CALENDAR:

August 2, 2018: Half-year 2018 business update and financial results
October 25, 2018: Q3 2017 business update and financial results