On May 1, 2018 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, reported it has entered into an agreement with Thermo Fisher Scientific to leverage the Oncomine Dx Target Test as a companion diagnostic for Spectrum’s novel pan-HER inhibitor, poziotinib, which is in development for the treatment of non-small lung cancer (NSCLC) patients with EGFR and HER2 exon 20 insertion mutations (Press release, Spectrum Pharmaceuticals, MAY 1, 2018, View Source [SID1234525894]).

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"Spectrum is committed to precision medicine for unmet medical needs in oncology," said Tom Riga, Executive Vice President, Chief Operating and Commercial Officer of Spectrum Pharmaceuticals. "Thermo Fisher pioneered next-generation sequencing as the first multi-drug companion diagnostic for patients with non-small cell lung cancer when Oncomine Dx Target Test received premarket approval by the FDA in June 2017. Therefore, we believe Thermo Fisher will be an outstanding partner to help us advance the development of poziotinib. As promising clinical data continue to emerge with poziotinib for the treatment of patients with EGFR and HER2 exon 20 insertion mutations, the expansion of Oncomine Dx Target Test will aid in faster detection and future treatment of patients who are not well-served by currently available therapies."

Oncomine Dx Target Test is FDA approved to simultaneously report 23 genes clinically associated with NSCLC. Of those 23, three contain markers that are approved for use as companion diagnostics, enabling physicians to match patients to three FDA-approved therapies in days instead of weeks. The test uses Thermo Fisher’s proprietary Ion PGM Dx sequencing platform to interrogate patient samples with high reproducibility and rapid turnaround times, even when limited tumor tissue is available.

Under the terms of the collaboration agreement, the goal of the expanded use of the Oncomine Dx Target Test is to identify NSCLC patients with EGFR or HER2 exon 20 insertion mutations who may be candidates for treatment with poziotinib in Spectrum’s global territories.

"We are pleased to partner with Spectrum Pharmaceuticals to help advance its drug development program and expand the clinical utility of Oncomine Dx Target Test," said Joydeep Goswami, president of Clinical Next-Generation Sequencing and Oncology at Thermo Fisher Scientific. "We remain committed to help drive better health outcomes for patients who can benefit from targeted therapies more quickly."

About Poziotinib

Poziotinib is a novel, Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI) that inhibits the tyrosine kinase activity of EGFR as well as HER2 and HER4. Importantly this, in turn, leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of EGFR family receptors have been associated with a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer, and gastric cancer. Spectrum received exclusive license to develop, manufacture, and commercialize worldwide excluding Korea and China from Hanmi Pharmaceuticals. Poziotinib is currently being investigated by Spectrum and Hanmi in several mid-stage trials in multiple solid tumor indications.

On May 1, 2018 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on the development of curative therapeutics using CRISPR/Cas9 technology, reported financial results and operational progress for the first quarter of 2018 (Press release, Intellia Therapeutics, MAY 1, 2018, View Source [SID1234525914]).

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John Leonard, M.D., was appointed Intellia’s President and Chief Executive Officer in the first quarter of 2018, and one of his first initiatives was to broaden the Company’s strategy. "We are building the premier CRISPR-based genome editing company with leading in vivo and ex vivo capabilities," said Dr. Leonard. "We are very pleased with the scientific data generated from our in vivo non-human primate (NHP) studies, and the progress with our modular, scalable lipid nanoparticle (LNP) delivery system has allowed us to target a timeframe for our first Investigational New Drug (IND) submission. As we continue to execute on our full spectrum of in vivo and ex vivo genome editing platforms, we will share progress on our differentiated, wholly owned ex vivo approach, starting this month at the American Society of Gene and Cell Therapy Annual Meeting."

The Company announced today that it anticipates submitting an IND application for its lead indication, transthyretin amyloidosis (ATTR), by the end of 2019 and confirms plans to initiate IND-enabling studies in mid-2018. Over the past six months, ongoing NHP studies have demonstrated well-tolerated editing to therapeutically relevant levels of transthyretin (TTR) protein reduction (60 to 80 percent) after a single systemic administration via LNP delivery to NHP hepatocytes. Rates of editing were durable over the six-month period without re-dosing the animals. In support of the proposed IND submission, Intellia has narrowed the field of potential guides to its current development candidate for early human trials. The guide-optimization process used high-throughput screening to evaluate the entire TTR gene for those guides with high levels of activity and undetectable off-target cutting. The Company has completed studies to understand potential dosing regimens and is continuing studies on durability of the effect, both of which may expedite Phase I clinical trials. Intellia has also developed an enhanced LNP formulation through optimization campaigns that is currently being tested for multiple follow-on liver indications, and anticipates that this modular approach may minimize development timelines for each additional and subsequent liver-targeted product candidate.

Intellia has also demonstrated continued progression of its modular liver platform capability to knockout various targets of interest in the livers of mice, including SERPINA1 for alpha-1 antitrypsin deficiency (AATD) and HAO1 for primary hyperoxaluria type 1 (PH1), each of which has resulted in protein expression reductions believed to be therapeutically relevant. This initial knockout edit in AATD lays the groundwork for developing an approach that restores production of the missing protein in AATD, required for the amelioration of the disease.

The table below shows editing rates and corresponding protein reductions in the livers of mice for ATTR, AATD and PH1. ATTR and AATD both produce aberrant proteins hence treatment of these conditions requires reductions in the level of the disease-causing proteins. PH1 results from the low level activity of a particular protein for which treatment requires reducing the levels of substrate for that defective protein to metabolize, achieved by knocking out the gene that encodes HAO1. In each of these three cases, Intellia’s modular LNP delivery system achieved high levels of reduction of the targeted protein. These initial editing rates and corresponding protein reductions are evidence of Intellia’s ability to successfully target monogenic liver diseases by knocking out harmful genetic mutations.

Beyond the liver, the Company continues to advance its application of CRISPR/Cas9 technology to the central nervous system (CNS), including through its collaboration with Beverly Davidson, Ph.D., of the Children’s Hospital of Philadelphia, who will share updated LNP delivery data in a presentation at the American Society of Gene and Cell Therapy Annual Meeting later this month.

In ex vivo applications, Intellia seeks to develop allogeneic cellular therapies, which are cells derived from unmatched tissue donors, which are modified outside of the human body to allow them to be administered to an unrelated patient. This endeavor is supported through multiple efforts, including recently acquired access to intellectual property from researchers at the Karolinska Institutet and Intellia’s collaboration with Ospedale San Raffaele, announced in June of 2017.

In February of 2018, Cell Reports published Intellia’s first peer-reviewed paper entitled "A single administration of CRISPR/Cas9 lipid nanoparticles achieves robust and persistent in vivo genome editing." This landmark paper documented Intellia’s delivery of Cas9 mRNA and single guide RNA using its proprietary LNPs to achieve a 97 percent reduction in mouse TTR protein levels in the liver, which was sustained for at least 12 months.

During the course of 2018, Intellia plans to share additional preclinical data on its TTR genome editing program, including the achievement of a near ten-fold reduction in the required dose, derived via improvements in potency, as well as other knockout targets and data on delivery via LNPs to the CNS of NHPs. Additionally, Intellia plans to share preclinical data on both immuno-oncology and autoimmune disease targets in 2018.

First Quarter 2018 Financial Results

Collaboration Revenue

Collaboration revenue was $7.5 million for the first quarter of 2018, compared to $6.2 million during the first quarter of 2017. The increase in collaboration revenue in 2018 was primarily driven by amounts recognized under Intellia’s collaboration agreement with Regeneron.

Since inception through March 31, 2018, the Company has received $112.1 million in funding from the collaborations with Novartis and Regeneron, excluding amounts received for equity investments, and had an accounts receivable balance of $7.5 million at March 31, 2018.

Operating Expenses

Research and development expenses increased by $9.1 million to $22.5 million during the first quarter of 2018, compared to $13.4 million during the first quarter of 2017. This increase was driven primarily by the advancement of Intellia’s research programs, research personnel growth to support these programs, as well as the expansion of the development organization, and includes laboratory supplies and research materials such as reagents.

General and administrative expenses increased by $1.7 million to $7.4 million during the first quarter of 2018, compared to $5.7 million during the first quarter of 2017. This increase was driven primarily by increased salary and related headcount-based expenses to support Intellia’s larger research and development organization, public company compliance, and administrative obligations.

The Company’s net loss was $21.4 million for the first quarter of 2018, compared to $12.6 million during the first quarter of 2017.

Balance Sheet

Cash and cash equivalents at March 31, 2018, were $327.8 million, compared to $340.7 million at December 31, 2017.

Financial Guidance

The Company’s primary uses of capital will continue to be for research and development programs, laboratory and related supplies, compensation costs for current and future employees, consulting, legal and other regulatory expenses, patent prosecution filing and maintenance costs for Intellia’s licensed intellectual property, and general overhead costs.

As of March 31, 2018, the Company had an accumulated deficit of $137.0 million. The Company expects losses to increase as it continues to incur significant research and development expenses related to the advancement of Intellia’s therapeutic programs and ongoing operations. Based on Intellia’s research and development plans and expectations related to the progress of the Company’s programs, the Company expects that the cash and cash equivalents as of March 31, 2018, as well as technology access and research funding from Novartis and Regeneron, will enable Intellia to fund operating expenses and capital expenditures through mid-2020, excluding any potential milestone payments or extension fees that could be earned and distributed under the collaboration agreements with Novartis and Regeneron or any strategic use of capital not currently in the base-case planning assumptions.

On May 1, 2018 VBI Vaccines Inc. (NASDAQ: VBIV) ("VBI"), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported financial results for the first quarter ending March 31, 2018, and provided a corporate update (Press release, VBI Vaccines, MAY 1, 2018, View Source [SID1234525932]).

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"Following the completion of the $71.9 million financing in October 2017, we have made strong progress across our development programs, highlighted by the recent completion of enrollment of more than 1,600 participants in our Phase 3 PROTECT study of Sci-B-Vac, our Hepatitis B vaccine," said Jeff Baxter, President and CEO of VBI. "With data readouts from both our congenital cytomegalovirus (CMV) and glioblastoma (GBM) programs expected mid-year and in the second half of 2018, respectively, our goal for 2018 is to capitalize on the recent momentum and continue to create value, advancing all three of our lead clinical programs towards significant clinical milestones."

Recent Highlights and Upcoming Milestones
Sci-B-Vac for Hepatitis B
VBI initiated a pivotal Phase 3 clinical program for Sci-B-Vac, the Company’s Hepatitis B vaccine, in December 2017 in the U.S., Europe, and Canada. This program consists of two concurrent Phase 3 studies, the PROTECT study and the CONSTANT study.

The PROTECT study is designed to evaluate the safety and immunogenicity of Sci-B-Vac in more than 1,600 adults. The primary endpoints, which are stratified by age cohort, include assessment of the seroprotection rate after three doses of Sci-B-Vac Engerix-B. The secondary endpoint will evaluate speed to seroprotection, including assessment after two doses of Sci-B-Vac vs. three doses of Engerix-B.
In April 2018, VBI completed enrollment in the PROTECT study.
The CONSTANT study is designed to demonstrate lot-to-lot consistency for immune response in approximately 3,200 adults, as measured by geometric mean concentration (GMC) of antibodies across three independent, consecutively manufactured lots of Sci-B-Vac. The secondary endpoint will evaluate safety of Sci-B-Vac Engerix-B.
Enrollment is ongoing in the CONSTANT study.

Topline data are expected mid-year 2019.
The results from this pivotal Phase 3 program are intended to support future regulatory filings in the U.S., Europe, and Canada.
VBI-1501 for Congenital Cytomegalovirus (CMV)
VBI-1501 is currently being evaluated in a Phase 1 randomized, observer-blind, placebo-controlled study designed to evaluate the safety, tolerability, and immunogenicity of VBI-1501 in 128 CMV-negative, healthy adults.
In July 2017, VBI announced positive interim immunogenicity data from this Phase I study. After two of the three planned vaccinations, antibody responses against the CMV gB antigen were observed with clear evidence of dose-dependent boosting, seroconversion in 100% of subjects who received the highest dose, and clear benefit of the adjuvant alum.
VBI plans to report final safety and immunogenicity data from the study mid-year 2018, which will inform next steps for the clinical development of VBI-1501.
VBI-1901 for Glioblastoma (GBM)
In January 2018, VBI commenced patient dosing in a Phase 1/2a clinical study of VBI-1901 for the treatment of recurrent glioblastoma (rGBM).
The multi-center, open-label, two-part study will enroll up to 28 patients and is designed to evaluate safety, tolerability, and the optimal therapeutic dose level of VBI-1901.
In April 2018, VBI announced that the independent Data and Safety Monitoring Board (DSMB) unanimously recommended continuation of the Phase 1/2a clinical study without modification after review of all safety data from the fully enrolled, low-dose patient cohort.
Following this recommendation, VBI initiated patient enrollment in the intermediate-dose arm of the dose-escalation phase of the study.
Two additional, pre-specified DSMB reviews are planned to occur following the completion of enrollment in the intermediate-dose study arm and the high-dose study arm, respectively.
Extensive biomarker testing and tumor imaging is built into this clinical protocol, such that VBI expects to generate immunologic data that will show whether VBI-1901 is inducing an immune response as expected.
In the second half of 2018, VBI hopes to be able to correlate this immunologic and biomarker data with initial clinical outcomes, and in early 2019, 6-month overall survival (OS) and progression-free survival (PFS) data are expected.
First Quarter 2018 Financial Results
VBI ended the first quarter of 2018 with $58.1 million in cash and cash equivalents compared with $67.7 million as of December 31, 2017. Net cash used in operations for the three months ended March 31, 2018 was $8.6 million.
Revenue for the first quarter of 2018 was $0.2 million, compared with $0.1 million for the same period in 2017. The increase was primarily due to named-patient sales of Sci-B-Vac in Europe.
Research and development expenses were $7.0 million for the first quarter of 2018, as compared to $4.7 million for the same period in 2017. The increase was primarily due to the initiation of the Phase 3 program for Sci-B-Vac and the Phase 1/2a clinical study for VBI-1901 in recurrent GBM patients, but was partially offset by the reduction in research expenses as VBI-1901 moved from pre-clinical activity to clinical activity.
General and administrative expenses were $3.4 million for the first quarter of 2018, as compared to $3.0 million for the same period in 2017. The increase was primarily due to expanded headcount and facilities.
Net loss and net loss per share for the first quarter of 2018 were $12.3 million and $0.19, respectively, compared to a net loss of $8.6 million and a net loss per share of $0.22 for the first quarter of 2017.

On May 1, 2018 Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD), a commercial biotechnology company, reported on its first quarter 2018 results and recent business activities (Press release, Ironwood Pharmaceuticals, MAY 1, 2018, View Source;p=irol-newsArticle&ID=2345875 [SID1234525897]).

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"Ironwood’s first quarter results reflect year-over-year topline growth of 33%, significant commercial and pipeline progress, and continued financial discipline," said Peter Hecht, chief executive officer of Ironwood. "LINZESS continued to demonstrate strong demand, with 15% year-over-year prescription volume growth. We believe we have alignment on Phase III design for IW-3718 following a productive end of Phase II meeting with the FDA and expect to initiate the IW-3718 trials in the third quarter of 2018. In addition, we continue to make good progress advancing our four Phase II trials with praliciguat and olinciguat, our lead clinical sGC stimulators."

First Quarter 2018 and Recent Highlights

Irritable Bowel Syndrome with Constipation (IBS-C) / Chronic Idiopathic Constipation (CIC)

U.S. LINZESS. U.S. net sales, as reported by Ironwood’s U.S. collaboration partner Allergan plc, were $159.3 million in the first quarter of 2018, an 8% increase compared to the first quarter of 2017. Ironwood and Allergan share equally in brand collaboration profits.
LINZESS commercial margin was 63% in the first quarter of 2018 compared to 52% in the first quarter of 2017.
Net profit for the LINZESS U.S. brand collaboration, net of commercial and research and development (R&D) expenses, was $88.8 million in the first quarter of 2018, a 43% increase compared to the first quarter of 2017.
Total LINZESS prescription volume in the first quarter of 2018 included approximately 30 million LINZESS capsules, an 15% increase in capsules compared to the first quarter of 2017, per IQVIA.
More than 764,000 total LINZESS prescriptions were filled in the first quarter of 2018, an approximately 9% increase compared to the first quarter of 2017, per IQVIA.
Since the launch of LINZESS in December 2012, greater than 2 million unique patients have filled approximately 10.6 million prescriptions, per IQVIA.
In January 2018, Ironwood and Allergan reached an agreement with wholly-owned subsidiaries of Sun Pharmaceutical Industries Ltd. (Sun Pharma, including its subsidiaries and/or associated companies), resolving patent litigation brought in response to Sun Pharma’s abbreviated new drug application (ANDA) seeking approval to market a generic version of LINZESS prior to the expiration of the companies’ patents. Pursuant to the terms of the settlement, Ironwood and Allergan will grant the wholly-owned subsidiaries of Sun Pharma a license to market a generic version of LINZESS in the U.S. beginning on February 1, 2031 (subject to U.S. FDA approval), unless certain limited circumstances, customary for settlement agreements of this nature, occur. As a result of the settlement, all Hatch-Waxman litigation between the companies and Sun Pharma regarding LINZESS patents has been dismissed.
Additional Abdominal Symptom Claims. Ironwood and Allergan expect to initiate a single Phase III trial with LINZESS in mid-2018 to evaluate its efficacy for relief of additional abdominal symptoms, including bloating and discomfort, two highly bothersome symptoms associated with IBS-C.
Linaclotide Delayed Release. An estimated 20 to 25 million patients suffer from IBS-mixed and IBS with diarrhea in the U.S. Ironwood and Allergan plan to advance into a Phase IIb clinical trial a linaclotide delayed release formulation as a potential visceral, non-opioid, pain-relieving agent for patients suffering from all subtypes of IBS. The companies are in active discussions with the U.S. FDA about this program.
LINZESS-Japan. Ironwood reported $5.4 million in sales of linaclotide active pharmaceutical ingredient (API) to its Japanese partner, Astellas Pharma Inc. in the first quarter of 2018.
Uncontrolled Gout

DUZALLO (lesinurad and allopurinol) and ZURAMPIC (lesinurad). Ironwood is systematically exploring a more comprehensive marketing mix for its lesinurad franchise, including DUZALLO and ZURAMPIC, in select test markets (with paired controls), while continuing to expand affordable access across the country. The data received from these test markets in 2018 are expected to inform our lesinurad franchise investment decisions. Combined U.S. net sales were $0.6 million in the first quarter of 2018.
Persistent Gastroesophageal Reflux Disease (GERD)

IW-3718. Ironwood is actively working to advance IW-3718, its gastric retentive formulation of a bile acid sequestrant for the potential treatment of persistent GERD, into Phase III trials. There are an estimated 10 million Americans who suffer regularly from symptoms of persistent GERD, such as heartburn and regurgitation, despite receiving treatment with the current standard of care, proton pump inhibitors.
Following a series of productive meetings with the U.S. FDA, Ironwood expects to initiate two randomized, placebo-controlled Phase III trials for IW-3718 in the third quarter of 2018. These trials are expected to evaluate the safety and efficacy of IW-3718 1500mg in patients with persistent GERD. The two trials are expected to enroll less than 800 patients each, with heartburn severity response as the primary endpoint. Further details on study design and endpoints will be provided upon the initiation of the trials.
Diabetic Nephropathy and Heart Failure with Preserved Ejection Fraction (HFpEF)

Praliciguat (IW-1973). Ironwood is enrolling patients in Phase II tirals to evaluate praliciguat, its lead soluble guanylate cyclase (sGC) stimulator, for the potential treatment of serious diseases, including diabetic nephropathy and HFpEF. Both diseases affect millions of patients around the world, including an estimated eight million Americans suffering from diabetic nephropathy and an estimated three million Americans suffering from HFpEF. Diabetic nephropathy is the leading cause of end-stage renal disease. There are few treatment options available to delay the steady decline of renal function leading to dialysis or kidney transplant. HFpEF is a highly symptomatic condition with high rates of morbidity and mortality, with no approved treatments available.
Diabetic nephropathy. Ironwood expects to enroll approximately 150 patients into a randomized, double-blind, placebo-controlled, dose-ranging Phase II trial designed to evaluate the safety and efficacy of praliciguat in patients with diabetic nephropathy.
HFpEF. Ironwood expects to enroll approximately 325 patients into a randomized, double-blind, placebo-controlled, dose-ranging Phase II trial designed to evaluate the safety and efficacy of praliciguat in patients with HFpEF.
Sickle Cell Disease and Achalasia

Olinciguat (IW-1701). Ironwood is enrolling patients in Phase II trials to evaluate olinciguat, its second clinical sGC stimulator, for the potential treatment of sickle cell disease and of achalasia. Sickle cell disease is a rare, debilitating genetic disorder that affects approximately 100,000 Americans and causes red blood cells to become sickle-shaped, reducing normal red blood cell number. Achalasia is a rare disease with a prevalence rate of 10/100,000 Americans in which the lower esophagus does not relax normally, causing dysphagia (swallowing problems), regurgitation, and chest pain.
Sickle Cell Disease. Ironwood expects to enroll approximately 80 patients into a multicenter, randomized, double-blind, placebo-controlled, dose-ranging Phase II trial of olinciguat in patients with sickle cell disease. The Phase II trial is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of olinciguat in these patients.
Achalasia. Ironwood continues to enroll patients into a randomized, double-blind, placebo-controlled, single-dose Phase IIa study of olinciguat in patients with achalasia. This study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of olinciguat in these patients. Data from this study are expected in 2018.
Corporate and Financials

Total Revenues
Total revenues were $69.2 million in the first quarter of 2018 compared to $52.2 million in the first quarter of 2017. Included in total revenues was $61.2 million associated with Ironwood’s share of the net profits from the sales of LINZESS in the U.S., $5.4 million in sales of linaclotide API to Astellas, $0.6 million in ZURAMPIC and DUZALLO product revenue, and $2.0 million in linaclotide royalties, co-promotion and other revenue.
Operating Expenses
Operating expenses were $105.0 million in the first quarter of 2018, compared to $91.8 million in the first quarter of 2017. Operating expenses in the first quarter of 2018 included $2.6 million in cost of revenues, $36.5 million in R&D expenses, $61.9 million in selling, general and administrative (SG&A) expenses, of which $2.4 million related to Ironwood’s field-based workforce reduction in January 2018, $3.5 million in acquired intangible assets amortization expenses, and a $0.5 million loss on fair value remeasurement of contingent consideration.
Contingent consideration and amortization of acquired intangible assets relate to Ironwood’s license agreement with AstraZeneca for the exclusive U.S. rights to all products containing lesinurad.
Other Expense
Interest Expense. Net interest expense was $8.6 million in the first quarter of 2018, primarily in connection with the $150 million 8.375% Notes funded in January 2017 and the approximately $336 million convertible debt financing funded in June 2015. Interest expense recorded in the first quarter of 2018 includes $5.0 million in cash expense and $4.2 million in non-cash expense.
Gain on Derivatives. Ironwood recorded a gain on derivatives related to the change in fair value of the convertible note hedges and note hedge warrants issued in connection with the convertible debt financing funded in June 2015. A gain on derivatives of $1.3 million was recorded in the first quarter of 2018.
Net Loss
GAAP net loss was $43.1 million, or $0.29 per share, in the first quarter of 2018, compared to a net loss of $52.5 million, or $0.36 per share, in the first quarter of 2017.
Non-GAAP net loss was $40.5 million, or $0.27 per share, in the first quarter of 2018, compared to $48.3 million, or $0.33 per share, in the first quarter of 2017. Non-GAAP net loss excludes the impact of mark-to-market adjustments on the derivatives related to Ironwood’s convertible debt, as well as the amortization of acquired intangible assets and the fair value remeasurement of contingent consideration related to Ironwood’s U.S. lesinurad license. See Non-GAAP Financial Measures below.
Cash Position
Ironwood ended the first quarter of 2018 with approximately $194.4 million of cash, cash equivalents and available-for-sale securities. Ironwood used approximately $30.9 million of cash for operations during the first quarter of 2018.
Non-GAAP Financial Measures
The company presents non-GAAP net loss and non-GAAP net loss per share to exclude the impact of net gains and losses on the derivatives related to our convertible notes that are required to be marked-to-market, as well as the amortization of acquired intangible assets and the fair value remeasurement of contingent consideration associated with Ironwood’s U.S. license agreement with AstraZeneca for the exclusive rights to all products containing lesinurad. The derivative gains and losses may be highly variable, difficult to predict and of a size that could have a substantial impact on the company’s reported results of operations in any given period. The acquired intangible assets are valued as of the date of acquisition and are amortized over their estimated economic useful life, and management believes excluding the amortization of acquired intangible assets provides more consistency with the treatment of internally developed intangible assets for which research and development costs were previously expensed. The contingent consideration balance is remeasured each reporting period, and the resulting change in fair value impacts the company’s reported results of operations. The changes in the fair value remeasurement of contingent consideration do not correlate to the company’s actual cash payment obligations in the relevant period. Management believes this non-GAAP information is useful for investors, taken in conjunction with Ironwood’s GAAP financial statements, because it provides greater transparency and period-over-period comparability with respect to Ironwood’s operating performance. These measures are also used by management to assess the performance of the business. Investors should consider these non-GAAP measures only as a supplement to, not as a substitute for or as superior to, measures of financial performance prepared in accordance with GAAP. In addition, these non-GAAP financial measures are unlikely to be comparable with non-GAAP information provided by other companies. For a reconciliation of these non-GAAP financial measures to the most comparable GAAP measures, please refer to the table at the end of this press release.

Conference Call Information
Ironwood will host a conference call and webcast at 8:30 a.m. Eastern Time on Tuesday, May 1, 2018 to discuss its first quarter 2018 results and recent business activities. Individuals interested in participating in the call should dial (877) 643-7155 (U.S. and Canada) or (914) 495-8552 (international) using conference ID number 9859406. To access the webcast, please visit the Investors section of Ironwood’s website at www.ironwoodpharma.com at least 15 minutes prior to the start of the call to ensure adequate time for any software downloads that may be required. The call will be available for replay via telephone starting at approximately 11:30 a.m. Eastern Time, on May 1, 2018 running through 11:59 p.m. Eastern Time on May 8, 2018. To listen to the replay, dial (855) 859-2056 (U.S. and Canada) or (404) 537-3406 (international) using conference ID number 9859406. The archived webcast will be available on Ironwood’s website for 14 days beginning approximately one hour after the call has completed.

On May 1, 2018 Kura Oncology, Inc. (Nasdaq:KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for oncology, reported that it will report first quarter 2018 financial results after the close of U.S. financial markets on Tuesday, May 8, 2018 (Press release, Kura Oncology, MAY 1, 2018, View Source [SID1234525915]). Kura’s management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT that day to discuss the financial results and provide a corporate update.

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The live call may be accessed by dialing 877-516-3514 for domestic callers and 281-973-6129 for international callers and entering the conference code: 7199738. A live webcast and archive of the call will be available online from the investor relations section of the company website at www.kuraoncology.com.