On May 04, 2016 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, reported financial results for the first quarter ended March 31, 2016. Loxo Oncology will not be conducting a conference call in conjunction with this earnings release (Press release, Loxo Oncology, MAY 4, 2016, View Source [SID:1234511891]).

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"With cash runway well into 2018, we are nicely positioned to bring our programs through new and meaningful milestones," said Josh Bilenker, M.D., chief executive officer of Loxo Oncology. "In the first half of 2016, we were able to show continued and durable efficacy for LOXO-101 in TRK fusion cancer patients as part of our Phase 1 update at AACR (Free AACR Whitepaper). For the remainder of the year, we will continue to focus on Phase 2 enrollment, moving our highly selective RET inhibitor into the clinic, and advancing our TRK resistance program towards an IND filing. We look forward to providing an update on our Phase 2 enrollment progress by the end of the year."

Recent Highlights

Presented Data from Phase 1 Study of LOXO-101 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting

In April, Loxo Oncology presented updated data from the Phase 1 trial at the 2016 AACR (Free AACR Whitepaper) Annual Meeting in New Orleans. Key findings from the presentation included:

As of the March 25, 2016 data cutoff date, six patients with TRK fusion cancers had been evaluated for response across five different tumor types; all six had demonstrated significant tumor regressions, with five achieving a confirmed response by standard RECIST criteria.
No TRK fusion patients had progressed, with one patient in cycle 14, two patients in cycle 10, and three patients in cycle 7, as of the data cutoff date (1 cycle = 28 days).
Five of the six patients, all of whom remain on study, are being treated at or below the Phase 2 dose of 100mg BID.
Adverse events reported regardless of attribution to study drug were generally consistent with those previously presented. Adverse events included fatigue (33 percent), constipation (23 percent) and dizziness (23 percent). Grade 3 adverse events included fatigue, constipation, anemia, increased liver enzymes, dyspnea, abdominal pain, hypertension, hyperkalemia, delirium, pleural effusion and syncope.
Published Case Report of First Pediatric Response to LOXO-101 in the Journal Pediatric Blood and Cancer

In April, Loxo Oncology published a case report in the online edition of the peer-reviewed journal Pediatric Blood and Cancer, co-authored with Nemours Children’s Hospital, Northwestern University and St. Jude Children’s Research Hospital, describing a partial response in the first patient with a TRK fusion cancer enrolled in the pediatric Phase 1 dose-escalation trial of LOXO-101. Key highlights include:

The report describes a 16-month old female patient with advanced infantile fibrosarcoma (IFS), a rare pediatric cancer. Genetic testing revealed an ETV6-NTRK3 fusion, which is frequently found in IFS.
At the end of cycle 1 (day 28), imaging of the brain and neck showed tumor regression of more than 90 percent from baseline.
Repeat scans at the end of cycle 2 showed a continued decrease in tumor volume. During the preparation of the manuscript, the patient was in study cycle 5 (~5 months), with a confirmed partial response by standard RECIST criteria
The patient experienced no adverse events related to LOXO-101 and was beginning to achieve normal developmental milestones.
Upcoming Milestones

Loxo Oncology continues to make significant progress across its drug development pipeline. Upcoming milestones are expected to include:

Continued enrollment of the LOXO-101 Phase 2 global, multi-center, single-arm, open-label basket trial in adult patients with solid tumors that harbor a TRK fusion; enrollment update expected in the second half of 2016.
Initiation of a Phase 1 study of a selective RET inhibitor expected in late 2016 or early 2017.
Initiation of a Phase 1 study of next-generation TRK inhibitor LOXO-195, addressing previously treated patients with acquired resistance, in 2017. LOXO-195 is designed to retain potency against a common resistance mutation that has been described in two separate patients who have progressed on a competitor’s TRK inhibitor.
First Quarter 2016 Financial Results

As of March 31, 2016 Loxo Oncology had aggregate cash, cash equivalents and investments of $144.8 million, compared to $153.9 million as of December 31, 2015.

Loxo Oncology continues to expect cash burn of $48 to $52 million in 2016, and based on the current operating plan, the company believes existing capital resources will be sufficient to fund anticipated operations well into 2018.

Research and development expenses were $8.4 million for the first quarter of 2016 compared to $3.8 million for the first quarter of 2015. This increase was primarily due to expanded clinical development activities for LOXO-101 and additional full-time equivalents and other support dedicated to discovery, preclinical, and manufacturing activities at Array BioPharma. Loxo Oncology also recognized research and development-related stock-based compensation expense of $0.3 million during the first quarter of 2016 compared to $0.5 million for the first quarter of 2015.

General and administrative expenses were $3.4 million for the first quarter of 2016 compared to $2.4 million for the first quarter of 2015. The increase was due to increases in employment costs and professional fees. Loxo Oncology also recognized general and administrative-related stock-based compensation expense of $1.0 million during the first quarter 2016 compared to $0.6 million for the first quarter 2015.

Net loss was $11.6 million and $6.2 million for the first quarters 2016 and 2015, respectively.

About LOXO-101
LOXO-101 is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities involving the tropomyosin receptor kinases (TRKs). Growing research suggests that the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body. In an ongoing Phase 1 clinical trial, LOXO-101 has demonstrated encouraging preliminary efficacy. LOXO-101 is also being evaluated in a global Phase 2 multi-center basket trial in patients with solid tumors that harbor TRK gene fusions and a Phase 1 trial in pediatric patients. For additional information about the LOXO-101 clinical trials, please refer to www.clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology Physician and Patient Clinical Trial Hotline at 1-855-NTRK-123.

About Loxo Oncology

Multiple testing refers to situations where a dataset is subjected to statistical testing multiple times – either at multiple time-points or through multiple subgroups or for multiple end-points. This amplifies the probability of a false-positive finding. In this article, we look at the consequences of multiple testing and explore various methods to deal with this issue.

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On May 4, 2016 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported financial results for the three months ended March 31, 2016, and provided an operating forecast and program updates (Press release, Ligand, MAY 4, 2016, View Source [SID:1234511889]).

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Financial highlights for the first quarter of 2016 include:

First quarter total revenues were $29.6 million, including royalty revenues of $14.4 million.
First quarter adjusted EPS was $0.97 and GAAP EPS was $0.30.
A description of adjusted calculations and reconciliation to comparable GAAP financial measures is provided in the accompanying table titled "Adjusted Financial Measures."

"The year is off to a strong start with product approvals and launches from our partners, positive data from multiple programs and robust quarterly growth in revenues. We closed two acquisitions recently, including a major acquisition in the first quarter that will contribute significantly to our portfolio of fully funded programs and financial performance. In addition, we completed multiple new licensing agreements, including those with our recently acquired OmniAb technology," said John Higgins, Chief Executive Officer of Ligand. "We look forward to total revenues growing by approximately 60% in 2016, and to the approval and launch of up to five of our partnered products during the year."

First Quarter 2016 Financial Results

Total revenues for the first quarter of 2016 were $29.6 million, compared with $14.6 million for the same period in 2015. Royalty revenues were $14.4 million, compared with $10.3 million for the same period in 2015 primarily due to higher royalties from Promacta and Kyprolis. Material sales were $5.3 million, compared with $3.7 million for the same period in 2015 due to timing of Captisol purchases for use in clinical trials and commercial products. License and milestone revenues were $9.9 million, compared with $0.6 million for the same period in 2015 due primarily to the timing of milestones and upfront license fees earned, and the acquisition of Open Monoclonal Technology, Inc. ("OMT").

Cost of goods sold was $1.0 million for the first quarter of 2016, compared with $1.1 million for the same period in 2015 due to the timing and mix of Captisol sales. Amortization of intangibles was $2.5 million for the first quarter of 2016, compared with $0.6 million for the same period in 2015 due to additional amortization of intangibles related to the acquisition of OMT. Research and development expense was $4.0 million, compared with $3.4 million for the same period of 2015 as a result of timing of spending on internal development programs. General and administrative expense for the first quarter of 2016 was $6.8 million, compared with $6.0 million for the same period in 2015 due to costs associated with the OMT acquisition and non-cash stock-based compensation expense.

Net income for the first quarter of 2016 was $6.6 million, or $0.30 per diluted share, compared with net income for the first quarter of 2015 of $0.8 million, or $0.04 per diluted share. Adjusted net income for the first quarter of 2016 was $21.0 million, or $0.97 per diluted share, compared with adjusted net income for the first quarter of 2015 of $6.9 million, or $0.33 per diluted share.

As of March 31, 2016, Ligand had cash, cash equivalents and short-term investments of $113.2 million.

2016 Financial Forecast

Including the effects of the synthetic royalty acquisition from CorMatrix, Ligand now expects 2016 total revenues to be between $115 million and $119 million. This guidance assumes approximately $1 million of revenue from the CorMatrix assets in 2016. Ligand’s cash operating expenses are not expected to change due to this transaction. In 2016, adjusted EPS is projected to be in the range of $3.41 to $3.46, which includes approximately $0.04 of incremental EPS contribution from the acquisition.

For 2017, Ligand expects total revenues to exceed $160 million with adjusted EPS of more than $5.03. This guidance assumes approximately $2 million of revenue from the CorMatrix assets in 2017, and approximately $0.08 of incremental EPS contribution from the acquisition.

The adjusted earnings per diluted share guidance does not include changes in contingent liabilities, mark-to-market adjustment for amounts owed to licensors, non-cash stock-based compensation expense, non-cash debt-related costs, pro-rata non-cash net losses of Viking Therapeutics, non-cash amortization of acquired intangibles, non-cash tax expense and unissued shares relating to the Senior Convertible Note.

First Quarter 2016 and Recent Business Highlights

Recent Acquisitions

Today Ligand announced the acquisition of economic rights to multiple programs owned by CorMatrix. Ligand will pay $17.5 million and in return will receive a portion of revenue (synthetic royalty) from CorMatrix’s existing marketed products and will have the right to receive future synthetic royalties from potential future products. CorMatrix’s products are medical devices that are designed to permit the development and regrowth of human tissue. This transaction will be immediately accretive to Ligand and represents Ligand’s entry into the field of medical devices.
In January 2016, Ligand acquired OMT, Inc. and its OmniAb platform for consideration valued at the time of the acquisition at approximately $178 million. OmniAb license agreements existing at the time of acquisition initially added 16 shots on goal, with the potential for additional compounds to be generated from these partnerships. Partners at the time of acquisition included Amgen, Celgene, Genmab, Janssen, Merck KGaA, Pfizer, Seattle Genetics, Five Prime, Symphogen and various other biotechnology and pharmaceutical companies.
Portfolio Program Progress

Promacta/ Revolade

The European Commission approved Revolade (eltrombopag), a Novartis product, for the treatment of pediatric (age 1 and above) chronic immune (idiopathic) thrombocytopenic purpura (ITP) patients who are refractory to other treatments (e.g., corticosteroids, immunoglobulins). The approval includes the use of tablets as well as a new oral suspension formulation of Revolade, which is designed for younger children who may not be able to swallow tablets.
Kyprolis (carfilzomib), an Amgen Product Utilizing Captisol

On January 21, 2016, Amgen announced that FDA approved Kyprolis (carfilzomib) in combination with dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy. The FDA also approved Kyprolis as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy, converting to full approval the initial accelerated approval Kyprolis received in July 2012 as a single agent.
On January 28, 2016, Amgen announced Health Canada approval of Kyprolis (carfilzomib) in combination with lenalidomide and dexamethasone for the treatment of patients with relapsed multiple myeloma who have received one to three lines of therapy.
Additional Pipeline and Partner Developments

Spectrum Pharmaceuticals received FDA approval of EVOMELA (melphalan) for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma, and for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.
Spectrum Pharmaceuticals announced that the FDA granted seven years of Orphan Drug Exclusivity for EVOMELA for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma.
Duavive received EU pricing and was launched in Italy by Merck Sharp & Dohme, under license from Pfizer.
Alvogen Inc. received approval from the FDA for Captisol-enabled IV voriconazole.
Zydus Cadila announced the launch of Vivitra, a biosimilar of trastuzumab, in India. Ligand gained rights to royalties on sales of Vivitra in the March 2013 Selexis royalty acquisition.
Lundbeck announced the FDA accepted the resubmission of the NDA for IV carbamazepine. An action letter is anticipated before the end of 2016.
Retrophin announced completion of enrollment in the Phase 2 DUET study of Sparsentan for the treatment of focal segmental glomerulosclerosis (FSGS). The DUET study exceeded its enrollment target of 100 patients, and top-line results are expected in the third quarter of 2016.
Sage Therapeutics presented data that expanded scientific, clinical and burden-of-illness data for SAGE-547 at the 68th American Academy of Neurology Annual Meeting.
Coherus BioSciences and Baxalta announced that CHS-0214, a proposed biosimilar of Enbrel (etanercept) to which Ligand gained royalty rights in the March 2013 Selexis royalty acquisition, met its primary endpoint in a confirmatory, double-blind, randomized, controlled, two-part clinical study. This ongoing study is evaluating the efficacy and safety of CHS-0214 compared with Enbrel in patients with moderate-to-severe rheumatoid arthritis that is inadequately controlled with methotrexate.
Viking Therapeutics highlighted positive data from a Phase 1b trial of VK2809 (TR Beta) in subjects with mild hypercholesterolemia at the 65th Annual Scientific Session and Expo of the American College of Cardiology.
Merrimack Pharmaceuticals presented data on MM-302, MM-141 and MM-151 at the 2016 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.
Opthea Limited announced that the primary objective of safety in the dose-escalation phase of its ongoing first-in-human clinical trial of OPT-302, a novel VEGF-C/D ‘Trap’ therapy for wet age-related macular degeneration, had been met.
Marinus Pharmaceuticals announced that the FDA granted Orphan Drug designation for ganaxolone IV for the treatment of status epilepticus. A Phase 1 clinical trial evaluating the safety, tolerability and pharmacokinetics of ganaxolone IV is expected to initiate in the first half of 2016.
Marinus Pharmaceuticals presented preclinical data of ganaxolone IV, which showed robust activity in the model. The data were presented during an oral and poster presentations at the 68th American Academy of Neurology Annual Meeting.
AVEO Oncology announced granting CANbridge Life Sciences worldwide rights, excluding the United States, Canada and Mexico, to AV-203, AVEO’s clinical-stage ErbB3 (HER3) inhibitory antibody candidate.
The journal Nature published an article highlighting the efficacy of Gilead’s GS-5734 against the Ebola virus in rhesus monkeys.
New Licensing Deals

Ligand announced a worldwide license agreement with Emergent BioSolutions that allows Emergent to use the OmniAb platform to discover fully human mono- and bispecific antibodies. Ligand is eligible to receive annual access payments, fees on patent filings, milestone payments and royalties on future net sales of any antibodies discovered under the license.
Ligand announced a worldwide license agreement with Tizona Therapeutics that allows Tizona to use the OmniAb platform to discover fully human mono- and bispecific antibodies. Ligand is eligible to receive annual access payments, fees on patent filings, milestone payments and royalties on future net sales of any antibodies discovered under the license.
Ligand announced a worldwide license agreement with ABBA Therapeutics that allows ABBA to use the OmniAb platform to discover fully human mono- and bispecific antibodies. Ligand is eligible to receive milestone payments and royalties on future net sales of any antibodies discovered under the license.
Ligand entered into a Clinical Use Agreement with XTL Biopharmaceuticals to supply Captisol for use in the formulation of its lead drug, hCDR1, for the treatment of systemic lupus erythematosus. Under the terms of the agreement, Ligand is eligible to receive milestones and revenue from clinical Captisol sales.
Internal Glucagon Receptor Antagonist (GRA) Program

Ligand scientists gave an oral presentation on GRA at ENDO 2016 and presented a poster at the Levine-Riggs Diabetes Research Symposium, which highlighted data from the Phase 1b trial demonstrating that GRA significantly reduced fasting and post-prandial glucose in subjects with type 2 diabetes.
Adjusted Financial Measures

The adjusted financial measures discussed above and in the tables below for the three months ended March 31, 2016 and 2015 exclude stock-based compensation expense, non-cash debt-related costs, non-cash tax expense, changes in contingent liabilities, non-cash amortization of acquired intangibles, non-cash pro-rata net losses of Viking Therapeutics, fair value adjustments to Viking Therapeutics convertible note receivable, mark-to-market adjustment for amounts owed to licensors and unissued shares relating to the Senior Convertible Note.

Management has presented net income, net income per share, income from continuing operations and income from continuing operations per share in accordance with GAAP and on an adjusted basis. Ligand believes the presentation of adjusted financial measures provides useful supplementary information to investors and reflects amounts that are more closely aligned with the cash profits for the period as the items that are excluded from adjusted net income are all non-cash items. Ligand uses these adjusted financial measures in connection with its own budgeting and financial planning. These adjusted financial measures are in addition to, and not a substitute for, or superior to, measures of financial performance prepared in conformity with GAAP.

On May 04, 2016 Endocyte, Inc. (NASDAQ:ECYT), a leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy, reported financial results for the first quarter ending March 31, 2016, and provided a clinical update (Press release, Endocyte, MAY 4, 2016, View Source [SID:1234511887]).

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"We continue to be pleased with the progress of our two lead, clinical-stage assets, EC1456 and EC1169, in Phase 1 dose escalation studies. Both drugs are very well-tolerated and show evidence of anti-tumor activity. Maximum tolerated dose has not yet been reached with either drug," said Ron Ellis, Endocyte’s president and chief executive officer. "We look forward to providing more detailed updates on both of these dose escalation trials at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in June."

Endocyte recently announced promising data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, highlighting its preclinical work in the area of immuno-oncology. In collaboration with Purdue University, the company announced a novel approach that makes possible the engineering of a single universal chimeric antigen receptor (CAR) T cell that can be targeted to multiple receptors on cancer cells through the use of unique, small molecule, bispecific adaptors. This approach has the potential to address major challenges faced by other CAR T cell technologies, by improving the management of safety, having a mechanism to address tumor heterogeneity, and lowering the cost of therapy.

Also at AACR (Free AACR Whitepaper), Endocyte announced data reflecting the promise of synergistic activity of its SMDCs in combination with immune modulating therapies. The combination of EC1456 with an anti-PD1 antibody demonstrated curative activity in models expressing PD-L1. It was further demonstrated that treated animals developed an immune response when tumors were re-introduced months after the cessation of therapy.

"These new developments, along with our new lead development candidate in oncology, which deploys a dual mechanism of cytotoxic tumor cell killing plus activity against tumor associated macrophages, demonstrates the range of applications of our SMDC platform," added Ron Ellis. "The ability to target receptors with high specificity and deeply penetrate the tumor microenvironment uniquely positions SMDCs to be effective not only as targeted cytotoxic agents, but also by engaging the immune system to participate in the fight against disease. We look forward to a deeper discussion of the data and the science behind these approaches at a research event later this year."

Upcoming Expected Milestones

Phase 1 dose escalation updates on EC1456 and EC1169 at ASCO (Free ASCO Whitepaper) annual meeting in June 2016
EC1456 single agent efficacy data (tumor response) in non-small cell lung cancer before year-end 2016
EC1169 single agent efficacy data in prostate cancer in late 2016 or 2017
Updates on plans for earlier stage programs

First Quarter 2016 Financial Results

Endocyte reported a net loss of $10.2 million, or $0.24 per basic and diluted share, for the first quarter of 2016, compared to a net loss of $10.9 million, or $0.26 per basic and diluted share, for the same period in 2015.

Research and development expenses were $6.5 million for the first quarter of 2016, compared to $6.6 million for the same period in 2015. The slight decrease was primarily attributable to a decrease in expenses related to the TARGET trial which is now complete and a decrease in discovery research expenses, which were partially offset by an increase in expenses relating to the EC1169 dose escalation trial as well as an increase in compensation expenses, primarily for noncash stock compensation.

General and administrative expenses were $3.8 million for the first quarter of 2016, compared to $4.4 million for the same period in 2015. The decrease in expenses was primarily attributable to a reduction in legal and professional fees in the first quarter of 2016 as compared to the same period in 2015, which was partially offset by an increase in compensation expenses, primarily for noncash stock compensation.

Cash, cash equivalents and investments were $163.3 million at March 31, 2016, compared to $196.8 million at March 31, 2015, and $173.6 million at December 31, 2015.

Financial Expectations

The Company reiterated guidance that it expects its cash balance at the end of 2016 to be between $125 and $130 million.

On May 4, 2016 Delcath Systems, Inc. (NASDAQ: DCTH), a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers, reported financial results for the three months ended March 31, 2016 (Press release, Delcath Systems, MAY 4, 2016, View Source;p=RssLanding&cat=news&id=2164855 [SID:1234511886]).

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Highlights for the first quarter of 2016 and recent weeks include:

Initiation of patient enrollment in the global Phase 3 FOCUS Clinical Trial for Patients with Hepatic Dominant Ocular Melanoma (the FOCUS trial), which is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) to support marketing approval in the U.S.
Addition of two prestigious U.S. cancer centers as FOCUS trial clinical sites
Activation of Hacettepe University Clinic in Ankara, Turkey as the first CHEMOSAT commercial treatment center outside of the European Union
Initiation of hospital negotiations for definition of ZE reimbursement levels in Germany
Completion of more than 300 treatments with CHEMOSAT since the second generation of the system was launched
"We began 2016 with strong momentum in our clinical development program, kicking off the year with the acceptance of a SPA agreement with the FDA for initiation of our FOCUS Phase 3 trial," said Jennifer K. Simpson, Ph.D., MSN, CRNP, President and Chief Executive Office of Delcath. "We are delighted that three leading U.S. cancer centers are now open and several others have committed to participate in the FOCUS trial and we look forward to opening additional trial sites in both the U.S. and Europe over the course of 2016. We made further progress with our Phase 2 trial for hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC) and expect to report interim data on the ICC cohort mid-year.

"We also continued to make steady progress commercializing CHEMOSAT in Europe. In February hospitals in Germany began negotiations to determine coverage levels for CHEMOSAT under the ZE national reimbursement mechanism. We anticipate coverage levels to be defined in mid-to-late 2016, which we believe will enhance growth in procedure volumes in Germany beginning late this year and provide important validation for reimbursement appeals in other markets in Europe.

"In April we announced our first expansion into markets outside of the European Union with the activation of Hacettepe University Clinic in Ankara, Turkey. Hacettepe is a well-regarded cancer treatment center in Turkey, and we believe it will serve as an excellent hub for CHEMOSAT treatments in the entire region.

"We look forward to executing our strategic plan throughout the remainder of the year, which includes multiple presentations and publications of data in support of CHEMOSAT as a treatment for metastatic liver cancers," concluded Dr. Simpson.

First Quarter Financial Results

Total revenue for the first quarter of 2016 was $0.4 million. Selling, general and administrative expenses for the first quarter of 2016 were $2.4 million, an improvement of $0.6 million or 20% from $3.0 million reported for the same period in 2016, primarily attributable to a reduction in severance accruals related to workforce and lease restructurings. Research and development expenses increased to $1.3 million for the 2016 first quarter from $1.0 million for the same period in 2015, primarily due to increased investment in clinical development initiatives.

Total operating expenses for the first quarter of 2016 decreased to $3.7 million from $4.0 million for the same period in 2015. This reflects an increase in clinical development initiatives, partially offset by a reduction in severance and compensation-related expenses following significant workforce and lease restructurings, as well as a reduction in facility expenses.

The Company recorded a net loss for the three months ended March 31, 2016 of $1.8 million, a decrease of $1.7 million or 49% from a net loss of $3.5 million for the same period in 2015. This decrease in net loss is primarily due to a $1.3 million change in the fair value of the warrant liability, a non-cash item and a $0.3 million reduction in operating expenses.

Balance Sheet Highlights

As of March 31, 2016, Delcath had cash and cash equivalents of $9.5 million, compared with $12.6 million as of December 31, 2015. During the first quarter of 2016, the Company used $3.8 million in cash to fund its operating activities. Delcath believes it has sufficient capital to fund its operating activities through the third quarter of 2016.