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MorphoSys AG: MorphoSys Provides Updates on L-MIND and B-MIND Clinical Trials of MOR208 in Relapsed/Refractory DLBCL

On March 7, 2019 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; Nasdaq: MOR) reported updates on L-MIND and B-MIND, its two ongoing clinical trials of the investigational Fc-enhanced anti-CD19 antibody MOR208 in patients with relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL), who are not eligible for high-dose chemotherapy and autologous stem cell transplantation (Press release, MorphoSys, MAR 7, 2019, View Source [SID1234534128]).

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The L-MIND trial, the Company’s single-arm, open-label study investigating MOR208 in combination with lenalidomide, has completed enrollment and data are currently being analyzed. Topline results are expected to be released at a medical conference in mid-2019. The Company intends to use L-MIND as the basis for a regulatory filing to the FDA, which it expects to complete by the end of this year. In parallel, the Company has initiated discussions with National European Regulatory Authorities to explore the possibility of using the L-MIND study as the basis for the submission of a potential marketing authorization application (MAA) in Europe. If the European Medicines Agency (EMA) were to agree to accept a potential MAA based on L-MIND, submission of such an MAA could occur earlier than originally anticipated based on the B-MIND trial. MorphoSys is seeking scientific advice from EMA in the forthcoming months.

The B-MIND study, which compares MOR208 in combination with bendamustine versus rituximab plus bendamustine, continues as originally designed. Additionally, during the first quarter of 2019 and in agreement with the FDA, MorphoSys implemented an amendment of the B-MIND study. The scientific rationale for the amendment is based on published literature as well as MorphoSys’s own pre-clinical data, which indicate that MOR208 might be particularly active in patients who can be characterized by the presence of a certain biomarker. The amended B-MIND trial may serve, in addition to being potentially pivotal on its own, as a confirmatory study if conditional approval of MOR208 is granted based on L- MIND. Discussions with the FDA regarding the biomarker assay are currently being planned and are expected to take place in the middle of this year. The pre-planned, event-driven interim analysis of B-MIND remains projected to take place in the second half of 2019. Depending on the outcome of the interim analysis, an increase from 330 to 450 patients may be required, in which case an event-driven primary analysis of the study is expected in the first half of 2021.

"Our L-MIND trial continues as planned and we are on track to completing our regulatory submission to the FDA this year", commented Dr. Malte Peters, Chief Development Officer of Morphosys AG. "Further, we are having early conversations with European regulators about the possibility of using L-MIND as the basis for a filing in Europe. We hope to have a clearer picture of the regulatory path in Europe within the next several months. Following discussions with the FDA, we have introduced a co-primary endpoint into the B-MIND trial based on pre-clinical data that suggest the involvement of a certain biomarker. The amended B-MIND trial enables us to test the hypothesis that MOR208 shows enhanced activity in patients who can be identified using the biomarker, while in addition allowing us to test efficacy in the unselected patient population as originally planned."

About CD19 and MOR208
CD19 is broadly and homogeneously expressed across different B cell malignancies including DLBCL and CLL. CD19 has been reported to enhance B cell receptor (BCR) signaling, which is assumed important for B cell survival, making CD19 a potential target in B cell malignancies.
MOR208 is an investigational humanized Fc-engineered monoclonal antibody directed against CD19. Fc-modification of MOR208 is intended to lead to a significant potentiation of antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), thus aiming to improve a key mechanism of tumor cell killing. MOR208 has been observed in preclinical models to induce direct apoptosis by binding to CD19, which is assumed to be involved in B cell receptor (BCR) signaling.
MorphoSys is clinically investigating MOR208 as a therapeutic option in B cell malignancies in a number of ongoing combination trials. An open-label phase 2 combination trial (L-MIND study) is investigating the safety and efficacy of MOR208 in combination with lenalidomide in patients with relapsed/refractory DLBCL who are not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT). Based on interim data from L-MIND, in October 2017 the U.S. FDA granted Breakthrough Therapy Designation for MOR208 plus lenalidomide in this patient population. The pivotal phase 2/3 B-MIND study is designed to investigate MOR208 in combination with the chemotherapeutic agent bendamustine in patients with relapsed/refractory DLBCL who are not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT) in comparison to the combination of the anti-CD20 antibody rituximab plus bendamustine. In addition, MOR208 is currently being investigated in patients with relapsed/refractory CLL/SLL after discontinuation of a prior Bruton tyrosine kinase (BTK) inhibitor therapy (e.g. ibrutinib) in combination with idelalisib or venetoclax.

Aurinia Pharmaceuticals to Release Fourth Quarter and Full Year 2018 Financial Results on March 19, 2019

On March 7, 2019 Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) (the "Company") reported that it will release its fourth quarter and full year 2018 financial results on Tuesday, March 19, 2019, after the market closes (Press release, Aurinia Pharmaceuticals, MAR 7, 2019, View Source [SID1234534124]). Aurinia’s management team will host a conference call to discuss the company’s financial results for the fourth quarter and full year 2018 and to provide a general business update.

The conference call and webcast is scheduled for March 19, 2019 at 4:30pm ET. In order to participate in the conference call, please dial +1-877-407-9170 (Toll-free U.S. & Canada). An audio webcast can be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia’s website.

Navidea Biopharmaceuticals Reports Fourth Quarter and Full Year 2018 Financial Results

On March 7, 20019 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported its financial results for the fourth quarter and full year of 2018 (Press release, Navidea Biopharmaceuticals, MAR 7, 2019, View Source [SID1234534123]). Navidea reported total revenues for the quarter of $119,000. Net loss attributable to common stockholders was $3.2 million.

"Navidea had a productive quarter as we advanced the business and our novel imaging pipeline," said Mr. Jed A. Latkin, Chief Executive Officer of Navidea. "While we had many successes this past quarter, we will continue to work hard to advance the science and seek the go ahead from the FDA to commence our pivotal RA diagnostic trials. Our newly reconstituted board and the addition of our new Chief Medical Officer have reinvigorated our efforts to make this company a success."

Fourth Quarter 2018 Highlights and Subsequent Events

Filed a comprehensive three-part clinical trial proposal for imaging of rheumatoid arthritis with the U.S. Food and Drug Administration ("FDA"), following end-of-Phase 2 discussions

Presented corporate overviews at the 2018 BIO Investor Forum and the 2018 LD Micro Annual Event

Presented data on the Manocept platform at the 2018 ACR Annual Meeting and at the 2018 Radiological Society of North American Scientific Assembly and Annual Meeting

Received notification of acceptance by the NYSE American of the Company’s plan to regain compliance with continued listing standards; also received an extension of the deadline to remedy the low stock price to March 31, 2019

Won dismissal of Platinum litigation

Announced release of a letter by the FDA to the U.S. Patent and Trademark Office ("USPTO") indicating that the USPTO is allowed to extend the patent for Lymphoseek through May 2025

Appointed Adam D. Cutler and S. Kathryn Rouan, Ph.D. to the Navidea Board of Directors

Hired Michael S. Rosol, Ph.D. as Navidea’s Chief Medical Officer

Financial Results

Our consolidated balance sheets and statements of operations have been reclassified, as required by current accounting standards, for all periods presented to reflect the line of business sold to Cardinal Health 414, LLC in March 2017 as a discontinued operation. Accordingly, this discussion focuses on describing results of our operations as if we had not operated the discontinued operation during the periods being disclosed.

Total revenues for the fourth quarter of 2018 were $119,000, compared to $395,000 in the same period of 2017. The decrease was primarily due to a reduction in grant revenue related to SBIR grants from the NIH supporting Manocept development. Total revenues for the full year of 2018 were $1.2 million, compared to $1.8 million in 2017. The decrease was primarily due to a reduction in grant revenue, offset by increased license revenue related to the sublicense of NAV4694 to Meilleur. Revenue in both years included other revenue from our marketing partners in Europe and China related to development work performed at their request.

Research and development ("R&D") expenses for the fourth quarter of 2018 were $854,000, compared to $1.7 million in the same period of 2017. R&D expenses for the full year of 2018 were $4.2 million, compared to $4.5 million in 2017. The decrease in both periods was primarily due to net decreases in Manocept development costs for clinical trials, coupled with decreased compensation costs resulting from headcount reduction.

Selling, general and administrative ("SG&A") expenses for the fourth quarter of 2018 were $1.4 million, compared to $2.2 million in the same period of 2017. SG&A expenses for the full year of 2018 were $7.7 million, compared to $11.2 million during 2017. The net decrease in both periods was primarily due to decreased legal and professional services, as well as decreased general office, insurance, depreciation, rent, and travel expenses, offset by termination costs associated with the resignation of our former CEO in 2018.

Navidea’s net loss attributable to common stockholders for the fourth quarter of 2018 was $3.2 million, or $0.02 per share (basic), compared to a net loss attributable to common stockholders of $4.1 million, or $0.03 per share, for the same period in 2017. Navidea’s net loss attributable to common stockholders for the full year of 2018 was $16.1 million, or $0.09 per share (basic), compared to net income attributable to common stockholders of $74.9 million, or $0.47 per share, in 2017.

Navidea ended the fourth quarter of 2018 with $4.3 million in cash and investments.

Conference Call Details

Investors and the public are invited to dial into the earnings call through the information listed below, or participate via the audio webcast on the company website. Participants who would like to ask questions during the question and answer session will be prompted by the moderator, who will provide instructions.

Event:

Fourth Quarter 2018 Earnings and Business Update Conference Call

Date:

Thursday, March 7, 2019

Time:

5:00 pm (Eastern Time)

U.S. & Canada Dial-in:

877-407-0312

Conference ID:

13687788

Webcast Link:

View Source

The recorded conference call can be replayed and will be available for 90 days following the call, available on the investor relations page of Navidea’s corporate website at www.navidea.com.

Corvus Pharmaceuticals Reports Fourth Quarter and Full Year 2018 Financial Results and Provides Business Update

On March 7, 2019 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies, reported financial results for the fourth quarter and year ended December 31, 2018, and provided a business update (Press release, Corvus Pharmaceuticals, MAR 7, 2019, View Source [SID1234534121]).

"We continue to make significant progress in the clinic both with CPI-444 and with CPI-006, both as monotherapies and in combination with other agents and each other, positioning Corvus as a leader in the development of medicines that modulate the adenosine pathway," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "In addition, we recently discovered an adenosine gene signature that we believe sheds important insight on the mechanisms of action for CPI-444 and CPI-006, and provides a biomarker that could be vital in future clinical trials. The FDA also recently cleared our IND for CPI-818, an ITK inhibitor that represents a novel approach for the treatment of T-cell lymphomas and that will mark our third product candidate in the clinic."

Recent Achievements

CPI-444: A2A Receptor Antagonist of Adenosine

Continued enrollment of up to 50 patients with renal cell cancer (RCC) in an amended Phase 1b/2 clinical trial evaluating CPI-444 administered alone and in combination with Genentech’s Tecentriq (atezolizumab), an anti-PD-L1 antibody.
Continued enrollment of up to 60 patients with non-small cell lung cancer (NSCLC) in a Phase 1b/2 trial being conducted by Genentech as part of their MORPHEUS platform. The study is evaluating CPI-444 and Tecentriq in patients who have failed no more than two prior regimens.
CPI-444 preclinical study results were published in and featured on the cover of the October issue of the journal Cancer Immunology Research, which is an official journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper). The results demonstrated that CPI-444 induces dose dependent anti-tumor responses as a monotherapy and in combination with anti-PD-1, anti-PD-L1 and anti-CTLA-4 therapies.
Presented updated results from the original Phase 1/1b trial of CPI-444 at the SITC (Free SITC Whitepaper) 33rd Annual Meeting covering 33 patients receiving CPI-444 as a monotherapy and 35 patients receiving CPI-444 in combination with Tecentriq. The results showed disease control for more than 6 months was achieved in 17 percent and 35 percent of patients receiving monotherapy and combination therapy, respectively. In addition, for patients receiving combination therapy, 11 percent experienced a confirmed partial response (PR; as determined by RECIST criteria). For patients receiving monotherapy, one patient experienced a confirmed PR and one experienced an unconfirmed PR. Several patients in both groups experienced tumor regression not meeting the PR criteria.
Presented new data on the "adenosine gene signature" (AdenoSig), a biomarker associated with patient response to therapy with CPI-444, in a poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress. Presented updated AdenoSig data at the Immuno-Oncology 360° Conference that showed a relationship between this biomarker and angiogenesis gene expression data (or angiogenesis signature). These data suggest that patients with a high AdenoSig are potentially more likely to respond to treatment with CPI-444 and less likely to respond to VEGFR inhibitors.
CPI-006: Anti-CD73 Antibody

Continued enrollment of up to 350 patients with advanced cancer in a Phase 1/1b clinical trial evaluating CPI-006 as a single agent and in combination with either CPI-444 or an anti-PD-1. Enrollment is now in the dose escalation phase for CPI-006 administered as a single agent and in combination with CPI-444.
Presented updated biomarker data at the Immuno-Oncology 360° Conference that showed CPI-006 given as a monotherapy activated B cells, led to a redistribution of these cells and led to changes in other immune cells (e.g., changes in T helper to T suppressor ratios). These data are consistent with immune stimulation induced by CPI-006. It was also reported that CPI-006 reacted with an epitope on CD73 that led to blockade of adenosine production and expression of lymphocyte activation antigens that are independent of adenosine.
CPI-818: A small molecule ITK inhibitor

Preclinical data on CPI-818 was presented at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium, in November 2018. Such preclinical data demonstrated that orally-administered CPI-818 produced tumor regression in companion dogs with spontaneous, naturally occurring T-cell lymphomas, without significant toxicity.
The Company plans to evaluate CPI-818, an interleukin-2-inducible kinase (ITK) inhibitor, in a Phase 1/1b study in patients with several types of T-cell lymphomas, including peripheral T-cell lymphoma (PTCL), cutaneous T-cell lymphoma (CTCL) and others, with patient enrollment planned in March 2019.
Corporate Updates

Appointed Linda S. Grais, M.D., J.D., to the Company’s Board of Directors, replacing Peter Moldt, Ph.D., who served as a director since January 2015 and resigned his position.
Appointed Mehrdad Mobasher, M.D., M.P.H., as Vice President and Chief Medical Officer to oversee the Company’s pipeline of precisely-targeted investigational oncology therapies.
Financial Results

As of December 31, 2018, Corvus had cash, cash equivalents and marketable securities totaling $114.6 million. This compared to cash, cash equivalents and marketable securities of $90.1 million at December 31, 2017. The Company expects net cash utilization of $43 million to $47 million in 2019.

Research and development expenses for the three months and full year ended December 31, 2018 totaled $8.4 million and $38.6 million, respectively, compared to $9.7 million and $46.3 million for the same periods in 2017. In the fourth quarter of 2018, the decrease of $1.3 million was primarily due to a $2.8 million decrease in CPI-444 costs, partially offset by an increase of $1.2 million in CPI-818 costs. For the full year 2018, the decrease of $7.7 million was primarily due to a $12.8 million decrease in CPI-444 costs, partially offset by an increase of $2.9 million in CPI-818 costs and a $1.8 million increase in personnel and outside research costs.

The net loss for the three months and year ended December 31, 2018 was $10.5 million and $46.9 million, respectively, compared to $11.9 million and $55.7 million for the same periods in 2017. Total stock compensation expense for the three months and year ended December 31, 2018 was $1.8 million and $7.1 million, compared to $1.7 million and $6.2 million for the same periods in 2017.

Sunesis Pharmaceuticals Reports Fourth Quarter and Full-Year 2018 Financial Results and Recent Highlights

On March 7, 2019 Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) reported financial results for the fourth quarter and year ended December 31, 2018 (Press release, Sunesis, MAR 7, 2019, View Source [SID1234534114]). Loss from operations for the three months and year ended December 31, 2018 was $5.8 million and $25.7 million. As of December 31, 2018, cash and cash equivalents totaled $13.7 million. Subsequent to the end of the quarter, the company raised $20 million in gross proceeds from concurrent underwritten public offerings in January.

"We began 2019 by announcing the move into the 100 mg cohort for our Phase 1b/2 trial of vecabrutinib, an important milestone as we continue to believe that 100 – 300 mg will be the potentially therapeutic dose levels," said Dayton Misfeldt, Interim Chief Executive Officer of Sunesis. "To date, we have seen an encouraging safety profile, evidence of pharmacodynamic activity and some improvements in clinical symptoms in CLL and other B cell cancer patients both with and without BTK C481 mutations. We are targeting an update on our ongoing vecabrutinib trial at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress (EHA) (Free EHA Whitepaper) in June 2019. In addition, in January, we completed an equity offering with leading biotechnology investors that extends our runway through important clinical milestones."

Recent Highlights

Announced Advancement into 100mg Cohort. In January 2019, the Company announced that it had opened the 100 mg cohort in the Phase 1b/2 trial of its non-covalent BTK inhibitor vecabrutinib in adults with relapsed/refractory chronic lymphocytic leukemia (CLL) and other B-cell malignancies.

The latest protocol amendment, approved by most sites in February 2019, allows for upfront enrollment of up to 6 evaluable patients into a cohort, and we have taken advantage of this to allocate additional slots for the 100mg cohort. By studying more patients and collecting more data, we can better characterize vecabrutinib’s profile at this dose level.

Completion of $20 million Financing. In January, Sunesis announced the completion of an equity financing with net proceeds of approximately $18.4 million. The financing attracted participation from leading biotechnology investors and will allow Sunesis to advance vecabrutinib through important clinical milestones as we explore the potentially active dose levels.

Presentation of Preliminary Data at the ASH (Free ASH Whitepaper) Annual Meeting. In December 2018, Sunesis presented preliminary data from the Phase 1b/2 clinical trial of its non-covalent BTK inhibitor vecabrutinib in adults with relapsed/refractory chronic lymphocytic leukemia (CLL) and other B-cell malignancies.

Financial Highlights

Cash and cash equivalents totaled $13.7 million as of December 31, 2018, as compared to $31.8 million as of December 31, 2017. The decrease of $18.1 million was primarily due to $24.4 million of net cash used in operating activities, partially offset by $6.3 million in net proceeds from issuance of common stock.

Revenue was $0.2 million in 2018 as compared to $0.7 million in 2017, primarily due to deferred revenue related to the Royalty Agreement with RPI Finance Trust, which was fully amortized to revenue in March 2017.

Research and development expense was $3.3 million and $14.6 million for the three months and year ended December 31, 2018, as compared to $3.7 million and $21.5 million for the same periods in 2017. The decreases in 2018 were primarily due to the 2017 $2.5 million Biogen payment, a $2.8 million decrease in professional services related to the 2017 vosaroxin regulatory filing with the European Medicines Agency, and a $1.8 million decrease in salary and related expenses, partially offset by an increase in clinical expenses of $0.5 million for work related to the development of vecabrutinib.

General and administrative expense was $2.5 million and $11.3 million for the three months and year ended December 31, 2018, as compared to $2.8 million and $13.5 million for the same periods in 2017. The decreases in 2018 were primarily due to a $1.4 million decrease in professional services, a $0.5 million decrease in salary and related expenses, and a $0.3 million decrease in vosaroxin commercial expenses.

Interest expense was $0.3 million and $1.2 million for the three months and year ended December 31, 2018, as compared to $0.3 million and $1.4 million for the same periods in 2017. The decrease in 2018 was primarily due to the decrease in the outstanding notes payable.

Cash used in operating activities was $24.4 million for the year ended December 31, 2018, as compared to $36.1 million for the same period in 2017. Net cash used in operating activities in 2018 resulted primarily from the net loss of $26.6 million and changes in operating assets and liabilities of $0.6 million, offset by net adjustments for non-cash items of $2.8 million.

Loss from operations was $5.8 million and $25.7 million for the three months and year ended December 31, 2018, as compared to $6.4 million and $34.4 million for the same periods in 2017. Net loss was $6.0 million and $26.6 million for the three months and year ended December 31, 2018, as compared to $6.6 million and $35.5 million for the same periods in 2017.

Conference Call Information

Sunesis will host a conference today at 4:30 p.m. Eastern Time. The call can be accessed by dialing (844) 296-7720 (U.S. and Canada) or (574) 990-1148 (international) and entering passcode 6225859. To access the live audio webcast, or the subsequent archived recording, visit the "Investors and Media – Calendar of Events" section of the Sunesis website at www.sunesis.com. The webcast will be recorded and available for replay on the company’s website for two weeks.