On March 02, 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 fourth quarter ended December 31, 2015, and provided a clinical update (Press release, Endocyte, MAR 2, 2016, View Source [SID:1234509345]).

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"2015 laid the groundwork for what we expect to be an important year for Endocyte in 2016. After establishing strong proof of concept data with our first generation SMDC vintafolide, the advancements we’ve made with our second generation agents will be tested this year in patients selected by our companion imaging agents," said Ron Ellis, Endocyte’s president and chief executive officer. "These advancements include enhanced potency, higher dosing, extended drug circulation, and improved patient selection criteria enabled by more advanced imaging equipment now widely available. We look forward to providing updates on the efficacy and safety of these agents in targeted patients before the end of the year, as well as on exciting progress on the earlier-stage pipeline, including two new clinical development candidates."

"Having treated more than 60 patients with EC1456 and EC1169, we have been very pleased with the safety profile for both agents. Considering the potency of the warhead we are delivering, this speaks to the stability of the SMDCs and their specificity in targeting diseased cells," commented Alison Armour M.D., Endocyte’s Chief Medical Officer. "We are of course looking forward to reaching optimal dosing and begin evaluation of these agents in patients selected by our companion imaging agents. In the meantime, the imaging team has done some great work advancing the criteria for selecting patients."

EC1456 (Folate-targeted tubulysin) Development

Endocyte outlined the next phase of development for EC1456.

Dose escalation is underway, currently evaluating 2 schedules
Once maximum tolerated dose is determined, these schedules will be evaluated in up to 40 second-line non-small cell lung cancer (NSCLC) patients selected with EC20 imaging with all FR-positive disease
Response rates will be assessed after 15 patients enroll on each schedule to trigger the potential expansion of each cohort to 40
As the optimal schedule becomes evident, cohorts with new indications and combinations with other drugs may be initiated in preparation for randomized trials
In addition to NSCLC, triple-negative breast and ovarian cancers are priority target indications based on sensitivity to the drug payload and prominence of the FR
In NSCLC, the combination of EC1456 with approved PD1 inhibitors is among the most promising paths forward as pre-clinical models demonstrate the most compelling synergy observed by the company to date
EC1169 (PSMA-targeted tubulysin) Development

Endocyte also outlined the next phase of development for EC1169, which is currently in dose escalation with a once a week schedule. Once the maximum tolerated dose is determined, the drug will be evaluated as a single agent therapy in advanced prostate cancer patients previously treated with hormone therapy. The companion imaging agent, EC0652, has provided superior images of prostate-specific membrane antigen (PSMA) positive disease during dose escalation and will provide a valuable tool for patient selection.

Pipeline Programs Leverage SMDC Capability to Create Multiple New Opportunities

"We have been prudent to ensure our two lead programs have remained the priority for the company and that we have fully invested in the clinical activity required to optimize their success," commented Mike Sherman, Endocyte’s chief operating officer and chief financial officer. "With those programs well underway, we also want to make sure we take advantage of our unique SMDC capability and flexibility to extend this platform to include new mechanisms of action and new indications."

Upcoming Expected Milestones

Phase 1 dose escalation updates at ASCO (Free ASCO Whitepaper) (American Society of Clinical Oncology) Annual meeting
EC1456 single agent efficacy data (tumor response) in NSCLC before year-end 2016
EC1169 single agent efficacy data in prostate cancer in late 2016 or 2017
Updates on plans for earlier stage programs
Fourth Quarter 2015 Financial Results

Endocyte reported a net loss of $9.8 million, or $0.23 per basic and diluted share, for the fourth quarter of 2015, compared to a net loss of $8.1 million, or $0.19 per basic and diluted share, for the same period in 2014.

Research and development expenses were $6.4 million for the fourth quarter of 2015, compared to $4.0 million for the same period in 2014. In the fourth quarter of 2014 there was a reduction in the PROCEED termination accrual. With no comparable adjustment in the fourth quarter of 2015, this led to an increase in expense. The increase was also driven by an increase in the expenses related to the EC1456 and EC1169 dose escalation trials which now have more active patients.

General and administrative expenses were $3.5 million for the fourth quarter of 2015, compared to $4.2 million for the same period in 2014. The decrease in expenses was primarily attributable to a reduction in legal and professional fees in the fourth quarter of 2015 as compared to the same period in 2014.

Cash, cash equivalents and investments were $173.6 million at December 31, 2015, compared to $180.3 million at September 30, 2015, and $206.8 million at December 31, 2014.

Financial Expectations

The Company expects that its cash balance at the end of 2016 will be between $125 and $130 million. Spending is expected to increase from the first half of 2016 to the second half as the trials for EC1456 and EC1169 are expanded once the maximum tolerated doses are determined. The advancement of the pre-clinical programs is not expected to materially impact current levels of spending and are reflected in the 2016 cash guidance.

On March 2, 2016 OPKO Health, Inc. reported that its GeneDx subsidiary and business unit has been selected to give 11 platform talks and 18 poster presentations on a range of genetics-related topics at the 2016 American College of Medical Genetics and Genomics (ACMG) Annual Meeting (Press release, Opko Health, MAR 2, 2016, View Source [SID:1234509330]). These presentations support GeneDx’s position as an industry leader in the wider genomics industry.

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Marc Grodman MD, CEO of BioReference/GeneDX states, "We are honored to have such a large number of presentations accepted at this year’s ACMG meeting and believe the depth and scope of our contributions demonstrate not only our commitment in expanding the scope of our genomic testing but also a meaningful contribution to enrich the scientific community at large."

This year’s presentations cover a range of topics ranging from inherited cancer testing to whole exome sequencing. Some of GeneDx’s featured presentations at the meeting include:

GeneDx’s experience from the first 100 XomeDxXpress cases performed for patients in critical care including diagnostic yield and how the results impacted medical management;
The potential use of Whole Exome Sequencing for fetal anomalies and fetal demise;
The detection of mosaic variants in genes causing germline neurodevelopmental disorders, such as epilepsy;
Multiple talks describing genes that have recently been associated with neurodevelopmental delay, either as a new gene-disease association or as an expansion of a previously described clinical phenotype.

For a complete list of GeneDx’s platform presentations and posters, please visit the GeneDx website View Source or stop by and visit booth #413 at the 2016 ACMG conference to learn more.

Over the last several years, GeneDx has been striving to better understand the genetic causes of autism and intellectual disability through research and its robust Whole Exome Sequencing program, perhaps best demonstrated by several of the company’s presentations at this year’s ACMG annual meeting. Based on this increased understanding and knowledge, GeneDx is proud to announce the launch of its Autism/Intellectual Disability (ID) Xpanded Panel. This is a dynamic testing panel analyzing approximately 2,000 genes that have been associated with autism, intellectual disability and/or developmental delay.

On March 2, 2016 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) reported financial results for the year ending December 31, 2015, as well as a financial and operational outlook on 2016.

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Financial Year 2015 results and key operational achievements 2015:

FY2015 revenues of EUR 106.2 million (2014: EUR 64.0 million) and EBIT of EUR 17.2 million (2014: EUR -5.9 million) exceed latest financial guidance.

2015 revenues and EBIT have been significantly impacted by a non-recurring effect attributable to the ending of the collaboration with Celgene.

Strong cash position of EUR 298.4 million at end of 2015 (EUR 352.8 million end of 2014).

Product pipeline further expanded in 2015 to 103 programs (89 partnered, 14 proprietary) up from 94 programs (84 partnered, 10 proprietary) at year-end 2014.

Main cancer programs MOR208 and MOR202 with encouraging phase 2 clinical data in hematological indications non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL) (MOR208) and multiple myeloma (MOR202).

In EUR million* FY 2015 FY 2014 Q4 2015 Q4 2014

Group Revenues 106.2 64.0 12.3 17.0
Total Operating Expenses 93.7 70.1 30.1 19.0
Earnings Before Interest and Taxes (EBIT) 17.2 (5.9) (17.5) (2.2)
Consolidated Net Profit/(Loss) 14.9 (3.0) (13.3) (1.0)
Diluted Net Profit/(Loss) per Share 0.57 (0.12) (0.51) (0.04)
* Differences due to rounding

Operational and financial outlook 2016:

Partnered discovery: Phase 3 readouts and potential filings for approval for antibodies bimagrumab in sporadic inclusion body myositis (sIBM, Novartis) and guselkumab in psoriasis (Janssen) expected.

Proprietary development: Increase in R&D activities planned to advance existing clinical programs and to begin clinical development of MOR106 and MOR107 in 2016.

R&D budget for proprietary drug development expected to increase to EUR 76 to 83 million in 2016 (2015: EUR 56.6 million). The bulk of these expenses will flow into the clinical development of MorphoSys’s most advanced proprietary drug candidates.

Revenues 2016 expected in the amount of EUR 47 to 52 million. EBIT 2016 expected in a range from EUR -58 to -68 million.

Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG, stated: "The progress made in 2015 has contributed to MorphoSys now having a product pipeline that is broader and more mature than ever before. The first therapeutic antibodies are nearing market approval, bringing us closer to a product-based revenue stream that we expect will grow significantly in the years ahead. Meanwhile, our proprietary development portfolio is expanding and the two most advanced programs are approaching the decisive stage of clinical development. Across our entire pipeline, we see many programs which have the potential to transform the treatment of the diseases they address, to the benefit of all of our stakeholders, not least, the patients who they will help."

"MorphoSys’s portfolio is one of the broadest in the industry. This is supported by financial resources of close to EUR 300 million at the end of 2015 that allows us to operate from a position of strength. Our solid financial position enables us to increase R&D expenses to grow the Company’s value without losing sight of our prudent and efficient use of resources," commented Jens Holstein, Chief Financial Officer of MorphoSys AG.

Update on MorphoSys’s Proprietary Antibody Portfolio

At the end of 2015, MorphoSys’s proprietary portfolio comprised 14 (2014: 10) innovative development programs, of which 4 (2014: 3) are in clinical development.

MOR208 – An anti-CD19 antibody for the treatment of B cell malignancies.

At the 2015 ASCO (Free ASCO Whitepaper) and ASH (Free ASH Whitepaper) meetings, positive data from a phase 2a study with MOR208 in 92 patients with relapsed or refractory non-Hodgkin’s lymphoma (NHL) were presented.

At the 2015 ASH (Free ASH Whitepaper) meeting, investigators at The Ohio State University reported on an investigator-initiated trial (IIT) of a combination of MOR208 with lenalidomide in relapsed/refractory or treatment-naive CLL patients. This study has recently been amended to add MOR208 on top of ongoing therapy with ibrutinib in patients suffering a relapse.

In 2016, MorphoSys will start two clinical combination trials for MOR208 in DLBCL and one in CLL. One of the DLBCL trials is intended to transition into a pivotal study in 2017.

MOR202 – A HuCAL antibody against CD38 for treatment of multiple myeloma (MM).

Encouraging clinical data from the ongoing dose-escalation trial of MOR202 alone and/or in combination with lenalidomide or pomalidomide (IMiDs – immunomodulatory drugs) were presented at ASCO (Free ASCO Whitepaper) and ASH (Free ASH Whitepaper) 2015.

The 16 mg/kg MOR202 confirmation cohort is enrolling and the 16 mg/kg IMiDs combination cohorts will be initiated soon.
Patients receiving MOR202 plus pomalidomide have shown very encouraging responses, which have deepened considerably since first data was reported at ASH (Free ASH Whitepaper) in December 2015.

Updated clinical data will be presented at an upcoming medical conference.
MOR209/ES414 – An anti-PSMA/anti-CD3 bi-specific antibody targeting prostate cancer. The compound is part of a co-development and co-commercialization agreement between MorphoSys and Emergent BioSolutions.

After examination of the initial clinical data, it was decided to adjust the dosing regimen and administration of MOR209/ES414. Clinical development will continue in 2016 using an amended clinical development plan, with recruitment to start around mid-2016.
Under the terms of the updated collaboration agreement, MorphoSys’s cost sharing in the years 2016 to 2018 and future milestone payments payable to Emergent BioSolutions by MorphoSys were reduced.
MOR103 – A HuCAL antibody directed against GM-CSF, out-licensed to GlaxoSmithKline (GSK) in 2013, is being developed by GSK in inflammatory diseases.

In the third quarter of 2015, GSK announced the commencement of a phase 2b study with MOR103 (re-named GSK3196165) in rheumatoid arthritis.
GSK plans to initiate a phase 1b/2a study in osteoarthritis of the hand in 2016.
Progress within MorphoSys’s Partnered Pipeline

During 2015, the number of therapeutic antibodies in MorphoSys’s partner pipeline grew to a total of 89 (December 31, 2014: 84). Of those, 21 antibodies were in clinical development, 25 in preclinical development and 43 in the discovery phase at year-end.
Two new antibodies entered phase 1 clinical development in 2015.
Financial Review for the Fiscal Year 2015 (IFRS)

Group revenues for the full year 2015 increased by 66 % to EUR 106.2 million (2014: EUR 64.0 million). This increase is mainly due to a contribution of approximately EUR 59 million from the recognition of deferred revenues and a one-time payment attributable to the early termination of a collaboration with Celgene. The Proprietary Development segment achieved revenues of EUR 59.9 million (2014: EUR 15.0 million), resulting from the non-recurring effect attributable to the above event. Revenues in the Partnered Discovery segment of EUR 46.3 million included EUR 42.3 million in funded research and licensing fees (2014: EUR 43.6 million) and EUR 4.0 million in success-based payments (2014: EUR 5.4 million).

Total operating expenses for the full year 2015 increased by 34 % to EUR 93.7 million (2014: EUR 70.1 million). Total research and development expenses (R&D) increased by EUR 22.7 million to EUR 78.7 million in 2015 (2014: EUR 56.0 million) mainly due to higher costs for external laboratory services and personnel. R&D expenses for proprietary research and development amounted to EUR 56.6 million (2014: EUR 36.4 million). General and administrative expenses (G&A) amounted to EUR 15.1 million (2014: EUR 14.1 million). Personnel expenses from share-based payments are included in G&A expenses and R&D expenses. These expenses amounted to EUR 3.6 million in 2015 (2014: EUR 4.0 million). Other income and expenses amounted to EUR 4.7 million (2014: income of EUR 0.2 million).

Earnings before interest and taxes (EBIT) amounted to EUR 17.2 million (2014: EUR -5.9 million). The increase is driven by one-off effects in the context of the ending of the MOR202 collaboration with Celgene in the first quarter of 2015. Proprietary Development showed a segment EBIT of EUR 10.7 million (2014: EUR -18.4 million), while the Partnered Discovery segment reported an EBIT of EUR 20.4 million (2014: EUR 25.9 million).

Finance income for 2015 amounted to EUR 3.4 million (2014: EUR 1.6 million). The Group reported income tax expenses of EUR 5.7 million (2014: tax benefit of EUR 1.3 million). Due to the positive one-off effects realized in 2015, MorphoSys generated a consolidated net profit of EUR 14.9 million compared to a net loss of EUR -3.0 million in 2014. The diluted net result per share amounted to EUR 0.57 (2014: EUR -0.12).

On 31 December 2015, the Company had a cash position of EUR 298.4 million, compared to EUR 352.8 million on December 31, 2014. In the balance sheet this cash position is reported under the positions: cash and cash equivalents; available-for-sale financial assets; bonds, available-for-sale; financial assets classified as loans & receivables; and financial assets classified as loans & receivables, net of current portion.

Net cash outflow from operating activities in 2015 totaled EUR 23.5 million (2014: cash outflow EUR 14.2 million). Resulting from the exercise of 80,848 convertible bonds in 2015, the number of shares issued rose to 26,537,682 by December 31, 2015 (December 31, 2014: 26,456,834).

Fourth Quarter of 2015 (IFRS)

In the fourth quarter of 2015, the Company generated revenues in the amount of EUR 12.3 million, compared to EUR 17.0 million in the same quarter of 2014. Total operating expenses amounted to EUR 30.1 million in Q4, compared to EUR 19.0 million in the same quarter of 2014. The increase in operating expenses was mainly due to higher expenses for third party services. The EBIT amounted to EUR -17.5 million (Q4 2014: EUR -2.2 million). Group net loss for the fourth quarter 2015 was EUR -13.3 million, compared to a net loss of EUR -1.0 million in the fourth quarter of 2014.

Outlook for 2016

In line with its intention to advance and broaden its proprietary pipeline, MorphoSys will increase its spending on proprietary drug development in comparison to the previous year. The majority of the expenses will flow into the clinical development of MorphoSys’s most advanced drug candidates.

MOR208: MorphoSys plans to initiate two phase 2 trials, the first of which will combine MOR208 and lenalidomide in DLBCL, the second of which will combine MOR208 and idelalisib in ibrutinib-refractory CLL. In the second half of 2016, the Company will start a further study in DLBCL, combining MOR208 and bendamustine. This trial is intended to lead into a pivotal study in 2017.

MOR202: MorphoSys plans to generate additional clinical data from an ongoing phase 1/2a trial in multiple myeloma (MM) evaluating the confirmation cohort of 16 mg/kg MOR202 alone as well as the cohorts and confirmation cohorts of 16 mg/kg MOR202 in combination with lenalidomide or pomalidomide.

With MOR209, MorphoSys expects to continue the phase 1 trial in metastatic castration-resistant prostate cancer (mCRPC) using an amended dosing scheme.

MorphoSys expects to start clinical development of MOR106 (jointly developed with Galapagos) and of MOR107, the first drug candidate from the Company’s acquisition of Lanthio Pharma.

In the Partnered Discovery segment, MorphoSys expects two phase 3 readouts and potential filings for approval for the antibodies bimagrumab in sIBM (Novartis) and guselkumab in psoriasis (Janssen). This would mark the first approvals of HuCAL antibodies.
MorphoSys expects Group revenues for the 2016 financial year in the range of EUR 47 to 52 million. R&D expenses for proprietary drug development are expected to rise to EUR 76 to 83 million. The Company expects earnings before interest and taxes (EBIT) in a range of between EUR -58 to -68 million. This guidance does not include any potential in-licensing or co-development of further development candidates.

MorphoSys will hold its conference call and webcast today to present the Annual Financial Results 2015 and the Outlook 2016.