On May 10, 2018 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, reported its financial results for the first quarter ended March 31, 2018 (Press release, Calithera Biosciences, MAY 10, 2018, View Source [SID1234526468]). As of March 31, 2018, cash, cash equivalents and investments totaled $171.2 million.

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"In the first quarter we continued to work towards our goal of developing CB-839 as a potential new treatment option for advanced renal cell carcinoma," said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera. "We are currently enrolling a registration-enabling randomized double-blind placebo controlled trial of CB-839 with cabozantinib for the treatment of renal cell carcinoma and have received Fast Track designation from the FDA for this trial."

First Quarter 2018 and Recent Highlights

CB-839

Preclinical Combination Data Demonstrate Synergy of CB-839 with CDK4/6 and PARP inhibitors. In April 2018, we presented results at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting demonstrating that CB-839 has synergistic anti-proliferative activity when combined with a CDK4/6 inhibitor in colorectal carcinoma (CRC), triple negative breast cancer (TNBC), and ER+ breast cancer cell lines. CB-839 treatment in combination with PARP inhibitors has synergistic anti-proliferative activity in TNBC, CRC, non-small cell lung carcinoma, ovarian and prostate cancer cells. In vivo, the combination of CB-839 with PARP inhibitors or the CDK4/6 inhibitor each enhanced anti-tumor activity in animal models.

Initiated Randomized Phase 2 of CB-839 in Combination with Cabozantinib in Renal Cell Carcinoma. At the 2018 Genitourinary Cancer Symposium in February, we presented preliminary results of the Phase Ib trial of CB-839 in combination with cabozantinib, an oral tyrosine kinase inhibitor, showing that the combination demonstrated a 40% overall response rate in advanced clear cell RCC patients and a 100% disease control rate, with the safety profile of CB-839 plus cabozantinib generally consistent with that of cabozantinib monotherapy. On the basis of this efficacy and safety data, we initiated a randomized double-blind placebo controlled trial, known as CANTATA, comparing patients treated with cabozantinib and CB-839 to patients treated with cabozantinib alone. This trial will enroll approximately 300 clear cell renal cell carcinoma patients who have previously received one or two prior lines of therapy. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for CB-839 in combination with cabozantinib for the treatment of this patient population. In parallel, the ENTRATA trial, a randomized double-blind placebo-controlled study of later line patients, is enrolling approximately 66 patients to receive either everolimus and CB-839 or everolimus alone.

Abstracts Accepted for Presentation at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper). A phase 1 Investigator sponsored clinical trial of CB-839 plus capecitabine has been accepted for poster presentation at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper).1 In addition, Calithera and clinical collaborators will present two trials-in-progress abstracts, which describe the design of ongoing studies.
INCB001158

Enrolling INCB001158 Clinical Trials. INCB001158 is being evaluated in multiple clinical trials for the treatment of patients with solid tumors both as a monotherapy, and in combination with immunotherapies and chemotherapy. INCB001158 is being developed as part of a collaboration and license agreement with Incyte.
Selected First Quarter 2018 Financial Results

Cash, cash equivalents and investments totaled $171.2 million at March 31, 2018.

Collaboration revenue for the first quarter of 2018 was $5.2 million, compared with $4.2 million for the same period in the prior year, and represents the portion of deferred revenue recognized from our collaboration and license agreement with Incyte. The increase of $1.0 million was primarily due to a full quarter of activity in 2018 verses a partial quarter in 2017, partially offset by differences in accounting due to our adoption of the accounting standard related to revenue from contracts with customers, or ASC 606, on January 1, 2018.

Research and development expenses were $15.4 million for the three months ended March 31, 2018, compared with $6.6 million for the same period in the prior year. The increase of $8.8 million was primarily due to a $7.6 million increase in our CB-839 program to support our new and ongoing clinical trials, including our three Phase 2 trials, as well as an increase of $1.0 million from investment in our early stage research programs, and an increase of $0.2 million from our INCB001158 program.

General and administrative expenses were $3.5 million for the three months ended March 31, 2018, compared with $3.3 million for the same period in the prior year. The increase of $0.2 million was primarily due to $1.0 million in higher personnel-related costs, partially offset by $0.4 million of lower costs associated with entering into the Incyte agreement and $0.4 million lower expenses due to the execution of a sublease agreement for office and laboratory space, both in the first quarter of 2017.

Net loss for the three months ended March 31, 2018 was $13.2 million, or $0.37 per share.

On May 10, 2018 Intrexon Corporation (NYSE: XON), a leader in the engineering and industrialization of biology to improve the quality of life and health of the planet, reported its first quarter financial results for 2018 (Press release, Intrexon, MAY 10, 2018, View Source [SID1234526485]).

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Intrexon Corporation logo. (PRNewsFoto/Intrexon Corporation)

First Quarter 2018 Business HighlightsPrecigen, Inc., and ActoBio Therapeutics, Inc., began operating as standalone entities effective January 1, 2018 and are now wholly owned subsidiaries of Intrexon;
Intrexon’s Energy team demonstrated successful third party catalytic conversion of 2,3 BDO to 1,3 butadiene. The conversion efficiency exceeded both the Company’s financial model and synthetic rubber industry product quality expectations;
ActoBio Therapeutics and collaborator Intrexon T1D Partners, LLC, have been granted allowance by the U.S. Food & Drug Administration (FDA) for their Investigational New Drug (IND) application to initiate a Phase Ib/IIa study for the treatment of early onset type 1 diabetes with AG019, an innovative disease-modifying approach to induce immune tolerance;
Exemplar Genetics, a wholly owned subsidiary of Intrexon, announced the FDA exercised enforcement discretion clearing for commercial use as a research model the ExeGen ATM MiniSwine, which is genetically engineered to model ataxia telangiectasia (AT), a rare, inherited, predominantly neurological human disease. Following Exemplar’s previous approval of its ExeGen LDLR MiniSwine model for use in cardiovascular disease research, the ExeGen ATM model is the second engineered MiniSwine model reviewed and cleared by the FDA;
Okanagan Specialty Fruits (OSF), a wholly owned subsidiary of Intrexon, launched the sales of dried Arctic Goldens – Arctic ApBitz apple snacks – via Amazon;
Intrexon’s Industrial Products Division has demonstrated microbial production of cannabinoids that has potential to provide >20-fold reduction in Cost Of Goods with reduced environmental impacts for THC and CBD versus current synthetic and extraction-based routes;
Collaborator Fibrocell Science, Inc. (NASDAQ: FCSC) obtained allowance from the FDA to begin clinical trials for FCX-013, its gene therapy candidate for the treatment of moderate to severe localized scleroderma; and
In January, Intrexon sold 6,900,000 shares of its common stock in an underwritten public offering at a public offering price of $12.50 per share, including the exercise in full by the underwriters of their option to purchase an additional 900,000 shares of common stock. Gross proceeds to Intrexon from the offering were approximately $86.3 million before deducting the underwriting discount and other offering expenses payable by Intrexon.
Recent Developments:

2,3 BDO yields are up 25% since last reported and the rate of yield improvement is in line with Intrexon’s expectations and supports the Company’s plans to break ground on a 40,000 ton/year facility by year end;
Isobutanol yields are again improving and are up about 40% since last reported. This return to yield improvements for isobutanol was the result of the re-design of a promiscuous enzyme that was degrading product and making further optimization of the production pathway challenging;
Partnering activity concerning Intrexon’s methane bioconversion platform is robust with multiple parties engaged. Potential partners include both strategic and financial companies;
Xogenex, a majority-owned subsidiary of Precigen, has opened and is actively recruiting patients its Phase 1 trial of the gene therapy INXN-4001, which the company believes is the world’s first multigene cardiac therapeutic candidate expressing proteins from three effector genes for the treatment of heart disease;
OSF has completed the planting of 520,000 of the 600,000 Arctic apple trees planned for the year; and
AquaBounty Technologies, Inc. (NASDAQ: AQB), a majority-owned subsidiary of Intrexon, received FDA approval of its recirculating aquaculture system (RAS) salmon production facility in Indiana and is ready to commence U.S. production, pending final adoption of the recently released labeling standards issued by the United States Department of Agriculture.
First Quarter 2018 Financial Highlights:

Total revenues of $43.8 million, a decrease of 18% from the first quarter of 2017;
Net loss of $42.0 million attributable to Intrexon, or $(0.33) per basic share, including non-cash charges of $26.3 million;
Adjusted EBITDA of $(19.7) million, or $(0.15) per basic share;
The net change in deferred revenue related to upfront and milestone payments, which represents the cash and stock received from collaborators less the amount of revenue recognized during the period, was a decrease of $13.6 million compared to a decrease of $10.2 million in the first quarter of 2017; and
Cash, cash equivalents, and short-term investments totaled $120.2 million, the value of preferred shares totaled $166.1 million, and the value of common equity securities totaled $14.0 million at March 31, 2018.
"It was a solid quarter of execution throughout our company," commented Randal J. Kirk, Chairman and Chief Executive Officer of Intrexon. "Our partnering activities, now focusing on larger transactions with major players on our more mature programs and platforms, are gaining traction and momentum so the balance of the year is coming into focus for us in a satisfying way. Simultaneously, we saw that the Arctic ApBitz snacks of Okanagan Specialty Fruits genuinely delight customers as we had hoped, while the future availability of AquaBounty’s AquAdvantage salmon in U.S. markets took a major step forward."

Mr. Kirk concluded, "While getting products from our mature programs and platforms into commerce remains a great focus of our senior team, I must say that my gratitude and respect goes out especially to our scientific teams, several of which recently have been responsible for a number of ‘world first instance’ matters of true significance. This is especially so for our Energy team who seem to have solved a tremendously baffling technical issue that had been impeding further progress on isobutanol for several months."

First Quarter 2018 Financial Results Compared to Prior Year Period

Total revenues decreased $9.9 million, or 18%, from the quarter ended March 31, 2017. Collaboration and licensing revenues decreased $9.0 million from the quarter ended March 31, 2017 primarily due to the decrease in research and development services for certain of the Company’s exclusive channel collaborations, or ECCs, as the Company redeployed certain resources towards supporting prospective new platforms and partnering opportunities and began to focus more on the further development of relationships and structures that provide the Company with more control and ownership over the development process and commercialization path. This decrease was partially offset by the accelerated recognition of the remaining balance of previously deferred revenue related to the Company’s ECC with OvaScience, Inc., or OvaScience, which was mutually terminated in March 2018. Product revenues decreased $1.0 million, or 12%, primarily due to lower customer demand for cows and live calves combined with lower sales prices on cows. Gross margin on products declined in the current period as a result of increased operating costs associated with new product offerings.

Research and development expenses increased $3.1 million, or 9%, due primarily to increases in (i) salaries, benefits and other personnel costs for research and development employees and (ii) depreciation and amortization. Salaries, benefits and other personnel costs increased $1.5 million due to an increase in research and development headcount necessary to invest in current or expanding platforms and increased compensation expenses related to performance and retention incentives for research and development employees. Depreciation and amortization increased $1.2 million primarily as a result of (i) the amortization of developed technology acquired from GenVec, Inc., in June 2017, and (ii) additional research and development assets placed in service in 2017 at Oxitec. Selling, general and administrative (SG&A) expenses increased $4.6 million, or 13%. Salaries, benefits and other personnel costs increased $6.2 million primarily due to (i) increased headcount to support the Company’s expanding operations, (ii) increased compensation expenses related to performance and retention incentives for SG&A employees, and (iii) higher stock-based compensation expense due to the inclusion in the quarter ended March 31, 2017, of the reversal of previously recognized stock-based compensation expense for stock options granted to the Company’s former President who resigned in March 2017 as well as incremental stock-based compensation expenses associated with new equity grants issued in 2018. Legal and professional fees decreased $2.3 million primarily due to (i) decreased legal fees associated with ongoing litigation and (ii) decreased fees incurred for regulatory and other consultants.

The decrease in equity in net loss of affiliates of $2.5 million, or 50%, was directly related to the decrease in collaboration revenues from collaborators in which Intrexon owns an equity-method interest.

Conference Call and Webcast

The Company will host a conference call today Thursday, May 10th, at 5:30 PM ET to discuss the first quarter 2018 financial results and provide a general business update. The conference call may be accessed by dialing 1‑888-317-6003 (Domestic US), 1-866-284-3684 (Canada), and 1-412-317-6061 (International) and providing the number 3130312 to join the Intrexon Corporation Call. Participants may also access the live webcast through Intrexon’s website in the Investors section at View Source

On May 10, 2018 Synergy Pharmaceuticals Inc. (NASDAQ:SGYP), a biopharmaceutical company focused on the development and commercialization of novel gastrointestinal (GI) therapies, reported its financial results and business update for the three months ended March 31, 2018 (Press release, Synergy Pharmaceuticals, MAY 10, 2018, View Source [SID1234526501]).

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"The first quarter of 2018 was all about executing on our three key business priorities of optimizing the value of TRULANCE, ensuring a strong financial foundation, and continuing to explore all strategic business development opportunities," said Troy Hamilton, Chief Executive Officer of Synergy Pharmaceuticals Inc. "With TRULANCE, we saw continued growth in prescriptions, market share and its prescriber base and with the IBS-C launch in late February, we have the opportunity to continue to drive further sales growth. In addition, we continued to efficiently manage our operating expenses by prioritizing key investments in areas of high return, such as expanding market access. Finally, we amended our debt agreement to allow for more flexible access to capital as we are pursuing strategic options that align with our core mission to deliver exceptional value to our patients, customers and shareholders. Overall, our progress against our key business priorities during the first quarter reflect our commitment to maximizing shareholder value while also maintaining our focus on providing safe and effective treatment options for patients living with chronic GI conditions."

First Quarter 2018 and Recent Highlights

Optimizing the Value of TRULANCE

44,177 TRULANCE 30-count packs were dispensed in the first quarter of 2018, resulting in a total of 132,628 TRULANCE 30-count packs dispensed since the product’s launch on March 20, 2017, per IQVIA.
TRULANCE was the only prescription brand for CIC and IBS-C to show positive total and new prescription volume growth in the first quarter over the prior quarter, per IQVIA.
In the nine weeks since the launch of the IBS-C indication in late February, TRULANCE prescription volume grew 24% versus the prior nine weeks or nearly five times the branded CIC and IBS-C prescription market growth rate, per IQVIA.
The total number of unique healthcare practitioners prescribing TRULANCE since launch reached nearly 12,000 in the first quarter of 2018, increasing more than 20% over the prior quarter, per IQVIA.
TRULANCE currently has over 70% payer coverage across all segments including commercial, Medicare Part D and Managed Medicaid.
Ensuring a Strong Financial Foundation

Financial Results

Reported TRULANCE net sales were $8.6 million in the first quarter of 2018 compared to net sales of $9.4 million during the fourth quarter of 2017. TRULANCE first quarter net sales of $8.6 million increased by 18% compared to fourth quarter of 2017 adjusted net sales (non-GAAP) of $7.3 million.
Reported total operating expenses were $43.5 million in the first quarter of 2018 compared to total operating expenses of $43.8 million during the fourth quarter of 2017.
Total adjusted operating expenses (non-GAAP) were $40.6 million in the first quarter of 2018 compared to $41.1 million in total adjusted operating expenses (non-GAAP) in the fourth quarter of 2017.
In February 2018, Synergy amended its Term Loan agreement with CRG to provide more financial flexibility while the company continues to evaluate various strategic options. Synergy has the ability to access up to an additional $100 million in 2018 in three tranches.
Synergy received $5.0 million in non-refundable upfront payments related to the TRULANCE Canadian licensing agreement with Cipher Pharmaceuticals completed in February 2018. This payment was recorded as deferred revenue for the quarter and will be recognized as revenue upon meeting future contractual obligations. Under the terms of the licensing agreement, Synergy is eligible for an additional milestone payment upon regulatory approval in Canada, as well as royalties from Trulance product sales in Canada.
Synergy reported a net loss of $36.1 million, or $0.15 per share, for the first quarter of 2018.
Cash and cash equivalents were approximately $98.7 million at the end of the first quarter.
2018 Financial Guidance

As a result of ongoing efforts to improve cost efficiency measures, Synergy is lowering projected total adjusted operating expense (non-GAAP) guidance for 2018 to be in the range of $165 million – $175 million versus previously guided $175 million – $185 million.
Exploring All Strategic and Business Development Opportunities

Collaborations & Partnerships

Synergy initiated a partnership with the National Cancer Institute (NCI) to collaborate on a NCI-funded and managed clinical biomarker study to evaluate dolcanatide’s potential to prevent colorectal cancer. The study will assess the colorectal bioactivity of dolcanatide in healthy volunteers and will inform the feasibility and design of a larger study. This is the first clinical biomarker study evaluating the potential benefit of using a uroguanylin analog in colorectal cancer prevention. The advancement of Synergy’s proprietary uroguanylin analog, dolcanatide, into this clinical trial builds on Synergy and NCI scientists’ pioneering work showing the important role of uroguanylin in the complex biology of colorectal cancer.
Synergy’s Canadian partner, Cipher Pharmaceuticals, is currently in discussions with Health Canada and plans to file a New Drug Submission for TRULANCE in IBS-C in the second half of 2018. The regulatory review period is approximately one-year from the submission date.
Ongoing Strategic Review

Synergy continues to engage in an ongoing review of strategic business opportunities focused on maximizing shareholder value. This review process includes, but is not limited to, potential US and ex-US partnerships, licensing, and merger and acquisition transactions. Synergy expects to provide further updates on or before it reports second quarter 2018 results.
First-Quarter Conference Call & Webcast

Synergy will host a conference call and webcast today at 4:30 p.m. Eastern Time to discuss first quarter 2018 results. Participants may access the conference call by dialing 877-407-3978 (US and Canada) or 412-902-0039 (International). Please let the operator know you would like to join the Synergy Pharmaceuticals call. To access the webcast as well as a PDF copy of the presentation, please visit the Investors section of Synergy’s website at www.synergypharma.com.

An audio replay of the conference call will also be available beginning approximately two hours after the call’s conclusion, and will remain available through May 24, 2018. The replay may be accessed by dialing 877-660-6853 (U.S. and Canada) or 201-612-7415 (International) and entering conference ID number 13668774. A replay of the webcast will also be available on the Investors section of Synergy’s website at www.synergypharma.com.

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

On May 9, 2018 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage biopharmaceutical company focused on creating innovative cancer immunotherapies, reported financial results and recent corporate updates for the first quarter ended March 31, 2018 (Press release, Arcus Biosciences, MAY 9, 2018, View Source [SID1234526344]).

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"The first quarter of 2018 was another exciting period for the Company, as our immuno-oncology pipeline continues to advance," said Terry Rosen, Ph.D., Chief Executive Officer at Arcus. "We have submitted regulatory filings to initiate our first combination trials of AB928, our internally discovered dual adenosine receptor antagonist, with other anti-cancer agents, including our anti-PD-1 antibody, AB122, and expect to initiate dosing in patients in mid-2018. We are also on track to submit regulatory filings for our next two product candidates, AB154 and AB680, in the third quarter, and to end the year with four product candidates in clinical development."

Pipeline Updates and Upcoming Milestones

AB928 (dual A 2 R receptor antagonist)

Initiated the submission of regulatory filings for three Phase 1/1b trials to evaluate AB928 in combination with AB122 or chemotherapy. Each trial will evaluate AB928 in combination with AB122 and/or chemotherapy in selected tumor types and will be conducted in both Australia and the U.S. The trial protocols were designed to allow for the addition of other AB928 combinations over time, including triple combinations. There will be a dose-escalation portion which will be followed by dose-expansion cohorts once the recommended dose of AB928 for each combination has been selected. In both the dose-escalation portion and expansion cohorts, the Company will conduct significant biomarker analysis, designed to inform patient selection in future trials. Data from the dose-escalation portion of these trials will be presented in the first half of 2019. The three trials will evaluate AB928 combinations in the following tumor types:
— Gastrointestinal malignancies (initially colorectal and gastroesophageal cancers)
— Breast and gynecological (initially ovarian) malignancies
— Non-small cell lung cancer and renal cell carcinoma
Completed dosing in the ongoing Phase 1 double-blinded, placebo-controlled trial in healthy volunteers in April. Final results from this trial, including pharmacodynamic data for the 200 mg QD dosing cohort, are expected to be released in mid-2018.
Presented initial data from the Phase 1 trial in a poster presentation at the AACR (Free AACR Whitepaper) Annual Meeting in April. Data showed AB928 is safe and well tolerated at all doses evaluated (up to 200 mg QD) and achieves near complete inhibition of adenosine 2a receptor (A2aR) activation.
Presented preclinical data in a poster presentation at the AACR (Free AACR Whitepaper) Annual Meeting in April. Data demonstrated that AB928 in combination with doxorubicin or oxaliplatin results in greater immune activation and tumor control than that of chemotherapy alone in two different tumor models.
AB122 (anti-PD-1 antibody)

Initiated dosing of a third cohort in the ongoing Phase 1 dose-escalation trial in cancer patients in Australia. The Company plans to present safety, pharmacokinetic, receptor occupancy and clinical activity data from this trial in the second half of 2018.
Presented preclinical data in a poster presentation at the AACR (Free AACR Whitepaper) Annual Meeting in April. Data demonstrated that AB122 is similar to nivolumab in terms of binding affinity, selectivity and anti-tumor activity in an animal model.
AB154 (anti-TIGIT antibody)

Continued to advance CMC activities and GLP toxicology studies. These studies are being conducted in preparation for the first regulatory submission for AB154 expected in mid-2018.
AB680 (small molecule CD73 inhibitor)

Presented preclinical discovery and characterization data in a poster presentation at the AACR (Free AACR Whitepaper) Annual Meeting in April. Data demonstrated that AB680 significantly enhanced the activity of anti-PD-1 and anti-TIGIT antibodies (AB122 and AB154, respectively) in immune function assays demonstrating the potential of triple combination therapy. This drug has a predicted half-life in humans of several days, which should allow for a dosing regimen of every two or three weeks.
Preparing to submit the first regulatory filing to initiate a Phase 1 trial to evaluate AB680 in healthy volunteers. This trial, which is expected to start in the third quarter of 2018, is designed to evaluate the safety, pharmacokinetic and pharmacodynamic profile of AB680 in healthy volunteers. Clinical testing of AB680 in cancer patients is expected to begin in the first half of 2019.
Corporate Updates

The Company completed an initial public offering in March, raising approximately $124.7 million in net proceeds after deducting underwriter discounts and other offering-related costs through the sale of 9,200,000 shares of common stock at a public offering price of $15.00 per share. Proceeds from this offering are currently expected to fund the company into at least 2020.
First Quarter Financial Results:

At March 31, 2018, cash, cash equivalents and investments were $290.8 million, compared to $175.7 million at December 31, 2017. The increase was primarily due to the receipt of $124.7 million in net proceeds from the Company’s initial public offering, which was completed in March.
Collaboration and license revenue for the first quarter ended March 31, 2018 was $1.3 million, compared to no revenue for the same period in 2017. The increase in revenue was entirely due to revenue recognized from the Option and License Agreement the Company entered into with Taiho Pharmaceutical Co., Ltd. in September 2017.
Research and development expenses for the first quarter ended March 31, 2018 were $11.7 million, compared to $5.8 million for the same period in 2017. The increase of $5.9 million was primarily due to an increase in manufacturing and clinical costs to support our ongoing AB928 and AB122 clinical trials and an increase in R&D headcount to support the Company’s other programs.
General and administrative expenses for the first quarter ended March 31, 2018 were $2.9 million, compared to $1.5 million for the same period in 2017. The increase of $1.4 million was primarily due to higher legal and accounting fees and additional staff in key areas required to support a public company infrastructure, as well as increased facilities and office expenses related to our expanded facility in Hayward.
Net loss for the first quarter ended March 31, 2018 was $13.0 million, compared to $7.2 million for the same period in 2017. The increase in net loss was primarily attributable to the increase in operating expenses noted above.