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Navidea Reports First Quarter 2016 Financial Results

On May 17, 2016 Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), reported financial results for the first quarter of 2016 (Press release, Navidea Biopharmaceuticals, MAY 17, 2016, View Source;p=RssLanding&cat=news&id=2168843 [SID:1234512458]). Navidea reported total revenue for the first quarter of 2016 of $4.7 million, including Lymphoseek (technetium Tc 99m tilmanocept) injection sales revenue to Navidea of $3.8 million. The net loss attributable to common stockholders was $3.7 million.

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"Since the start of the year there have been numerous changes at Navidea as we position the company for the best return on the commercialization of our Lymphoseek immunodiagnostic product and our exciting Manocept therapeutic platform," said Jed Latkin, interim Chief Operating Officer. "Lymphoseek Q1 2016 revenue grew 8% quarter-on-quarter and 106% versus the same quarter last year and we expect much stronger revenue growth in future quarters reflective of the addition of four key regional sales reps and positive utilization trends observed in some major medical accounts. Of note, our operating expenses continue to decline and are significantly reduced from 2015 as we seek to gain operational cash flow breakeven in 2016."

Mr. Latkin continued, "Additionally we are making progress in expanding the clinical application of Lymphoseek into new solid tumors in the U.S. and an expected Q4 2016 launch in Europe, as well as immunodiagnostic indications such as Rheumatoid Arthritis and cardiovascular diseases. We are also obtaining baseline proof of concept data for technology in therapeutic applications. These therapeutic pre-clinical studies will allow us to seek a foundational partnership in each key therapeutic area to help fund development while maximizing return and minimizing the dilution to our shareholders. We look forward to a strong, eventful 2016."

PRODUCT, PIPELINE & BUSINESS UPDATES

Lymphoseek

Grew Lymphoseek revenue 106% in Q1 2016 versus same quarter last year, maintained gross margins on sales of Lymphoseek in excess of 85%, maintained high reorder rates in excess of 80% and continued to accelerate trial and adoption in major cancer centers;
Added and trained four new regional sales reps, expanding our sales team from 12 to 16 sales professionals supported by four Medical Science Liaisons (MSLs);
Broadened access to Lymphoseek though the voucher program and vial consignment program within major multi-hospital chains who have high potential to adopt Lymphoseek and who are influential in the practices of other institutions. These large multi-hospital accounts have the potential to rapidly increase volume growth; and
Continued market development clinical activities with Navidea and investigator-initiated studies in cervical cancer, pediatric solid tumors, anal-rectal cancer, endometrial cancer, and for further confirmation of workflow efficiency compared to sulfur colloid, which are supported in part by National Institutes of Health (NIH) grant funding.
Manocept Immunodiagnostic Pipeline

Advanced development efforts for intravenous (IV) and subcutaneous delivery supported by NIH grant funds in order to expand the label of tilmanocept;
Submitted non-clinical data package and held successful Food and Drug Administration (FDA) meeting in March with agreed submission of an Investigational New Drug (IND) amendment to the FDA that will allow initiation of IV clinical studies of Lymphoseek;
Awaiting Institutional Review Board (IRB) approval to begin sub-cutaneous Phase 1 study in Rheumatoid Arthritis (RA). Expect to begin Phase 1/2 IV study in RA later in the year;
Completed enrollment in a pilot cardiovascular imaging study evaluating detection of vulnerable plaque at Massachusetts General Hospital. Preliminary results are very promising and are being prepared for publication in medical journals; and
Expect to begin grant-funded Phase 1/2 evaluation of Lymphoseek – IV in Kaposi’s Sarcoma patients in the second half of 2016.
Manocept Immunotherapeutic Development Pipeline (Macrophage Therapeutics)

Completed an 8-week, preclinical mouse study in an arthritis mouse model with a Manocept anti-inflammatory targeted therapeutic product, MT2002, with initial results reporting clear anti-inflammatory activity with no apparent significant side effects;
Completed an animal study in an asthma model that measured the ability of MT2002 to decrease all three markers of pro-inflammatory markers secreted by disease-causing macrophages that successfully demonstrates an anti-inflammatory effect;
Completed dosing in two studies using a neuro-inflammation model and an animal model for NASH, nonalcoholic steatohepatitis, with results expected in coming weeks; and
Initiated a number of studies evaluating the performance of compounds from the MT1000 class of compounds designed to deplete tumor associated macrophages (TAMs) in a number of different cancer models.
Business

Named Jed Latkin as interim Chief Operating Officer to direct the Company’s day-to-day operations and act as principal executive officer and principal financial and accounting officer until replacements are hired following the departure of Rick Gonzalez as President and CEO and a medical leave by Brent Larson, EVP and CFO;
Named Marcum LLP as corporate independent registered public accounting firm following resignation of BDO USA, L.L.P.;
Announced appointment of Mark I. Greene, M.D., Ph.D. FRCP, Tony Fiorino, M.D., Ph.D. and Michael Rice to the Board of Directors and the departure of Brendan Ford, Anton Gueth, Rick Gonzalez and Gordon Troup; and
Capital Royalty Partners II L.P. (CRG) commenced a lawsuit alleging that events of default have occurred under the Company’s loan agreement with CRG. The Company intends to vigorously defend against these claims. The Company is evaluating its options, including the possible assertion of counterclaims.
FINANCIALS

Total revenues for the quarter ended March 31, 2016 were $4.7 million compared to $2.1 million in the first quarter of last year. First quarter 2016 product revenues recognized from the sale of Lymphoseek were $3.8 million, compared to $3.5 million in the fourth quarter of last year and $1.8 million in the first quarter of last year. This represents a sequential quarter-on-quarter growth of 8% and year-over-year growth of approximately 106%. Q1 2016 revenue for licensing milestones, various federal grants and other revenue were $940,000 compared to $791,000 in the fourth quarter of last year and $273,000 in the first quarter of last year.

Gross margins on Lymphoseek product sales remain strong at 86% for the first quarter of 2016 compared to 76% for the first quarter of 2015.

Total operating expenses were $6.8 million, compared to $9.5 million in the first quarter of last year. Research and development expenses for the first quarter of 2016 were $2.7 million, compared to $4.0 million in the first quarter of last year. The net decrease from 2015 to 2016 was primarily a result of reductions in NAV4694, NAV5001 and Lymphoseek product development costs coupled with reduced headcount and related support costs, offset by increased therapeutics product development costs. Selling, general and administrative expenses for the first quarter of 2016 were $4.1 million, compared to $5.5 million in the first quarter of last year. The net decrease was primarily due to decreased general and administrative headcount following the first quarter 2015 reduction in force coupled with decreased costs for contracted medical science liaisons, business development consulting services, market development expenses related to Lymphoseek, and license fees, offset by increased commercial and medical headcount coupled with increased legal and professional services.

Navidea’s net loss attributable to common stockholders for the quarter ended March 31, 2016 was $3.7 million, or $0.02 per share, compared to $7.3 million, or $0.05 per share, for the same period in 2015.

Based on CRG’s claims that the Company is in default under the terms of the CRG Loan Agreement, and in accordance with current accounting guidance, the Company has classified the net balance of the CRG Term Loan as a current liability on the consolidated balance sheet as of March 31, 2016.

Navidea ended the quarter with $5.5 million in cash.

The Company reiterates its 2016 total revenue estimate of $23 million to $25 million. Margins on Lymphoseek product sales are expected to continue to exceed 80% in the coming quarters. The Company also expects, following completion of the partnering activities for NAV4694, that cash operating expenses on a quarterly basis will continue to decrease to the point necessary for the Company to achieve its goals of cash flow breakeven from operations. This guidance excludes therapeutic-related research and development costs for the Manocept platform which are expected to be funded separately by Macrophage Therapeutics, Inc.

Foundation Medicine Receives Patent Covering Fundamental Methods in Comprehensive Genomic Analysis in Cancer

On May 17, 2016 Foundation Medicine, Inc. (NASDAQ:FMI) reported that the U.S. Patent and Trademark Office has issued U.S. patent number 9,340,830, entitled, "Optimization of Multigene Analysis of Tumor Samples (Press release, Foundation Medicine, MAY 17, 2016, View Source [SID:1234512446])." The patent, which is assigned to Foundation Medicine, includes fundamental claims describing methods of analyzing a cancer patient’s tissue or blood specimen to detect multiple classes of genomic alterations. The patent carries a term extending to 2032. The company is also pursuing patent applications covering aspects of its genomic analysis platform with the European Patent Office and in other jurisdictions outside the United States.

"Foundation Medicine has been at the leading edge of innovation in genomic analysis of cancer since our inception six years ago," said Michael Pellini, M.D, chief executive officer for Foundation Medicine. "We believe this patent both acknowledges our pioneering efforts in research and development, and, importantly, it demonstrates our expertise in translating innovation into clinically validated, best-in-class assays that benefit cancer patients around the world. We are gratified that our contributions to the clinical and scientific communities are enabling new genomic analysis products in the fight against cancer."

Dr. Pellini continued, "We believe patients and their physicians should have access to the full complement of test offerings that, when used appropriately, can meaningfully guide and inform treatment plans. We plan to evaluate strategies to maximize the value of this patent and our other intellectual property. That said, in leveraging this asset, we do not intend to block the use of methods covered by the patent in patient testing that may be offered by others. We are pleased with the issuance of this patent to strengthen Foundation Medicine’s intellectual property position and reinforce our overall leadership in transforming cancer care."

Ofatumumab in Combination with Fludarabine and Cyclophosphamide for Relapsed CLL accepted for priority review by FDA

On May 17, 2016 Genmab A/S (Nasdaq Copenhagen: GEN) reported that the U.S. Food and Drug Administration (FDA) granted Priority Review to the supplemental Biologics License Application (sBLA) for the use of ofatumumab (Arzerra) in combination with fludarabine and cyclophosphamide (FC) for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL) (Press release, Genmab, MAY 17, 2016, View Source [SID:1234512506]).

The application was submitted to the FDA by Novartis in March 2016 under the ofatumumab collaboration between Novartis and Genmab.

Priority Review is an FDA designation for drugs that treat serious conditions and which may provide a significant improvement in safety or efficacy compared to existing standard therapies. The FDA aims to complete its review of the ofatumumab sBLA within six months and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 10, 2016
"With the FDA’s acceptance of this sBLA, ofatumumab is one step closer to potentially benefiting an even wider population of patients than it is currently," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "We look forward to the FDA’s feedback on this application."

The application was based on results from a Phase III study, COMPLEMENT 2, which evaluated ofatumumab in combination with FC versus FC alone in patients with relapsed CLL. Top-line results from this trial were reported in April 2015.

About CLL
CLL is the most common form of leukemia in the western world, accounting for 30% of adult leukemias.1 Most CLL patients experience disease progression despite initial response to therapy and may require additional treatment.2

About COMPLEMENT 2
COMPLEMENT 2 (NCT00824265) is an open-label, two-arm, randomized, Phase III study, which included 365 patients in 18 countries with relapsed CLL. Patients in the study were randomized 1:1 to treatment with up to six cycles of ofatumumab in combination with fludarabine and cyclophosphamide or up to six cycles with fludarabine and cyclophosphamide alone.

The primary endpoint of the study was PFS, which was assessed by an Independent Review Committee (IRC) according to the International Workshop for Chronic Lymphocytic Leukaemia (iwCLL) updated 2008 National Cancer Institute-sponsored Working Group (NCIWG) guidelines.3 The study met the primary endpoint with a median progression free survival in patients receiving ofatumumab in combination with FC of 28.9 months, compared to 18.8 months in patients receiving FC alone (HR =0.67, p=0.0032). Secondary endpoints included overall response rate, overall survival, patient reported outcomes, time to response, duration of response, time to progression, time to next therapy, safety assessments and quality of life.

About Ofatumumab (Arzerra)
Ofatumumab is a human monoclonal antibody that is designed to target the CD20 molecule found on the surface of chronic lymphocytic leukemia (CLL) cells and normal B lymphocytes.

In the United States, Arzerra is approved for use in combination with chlorambucil for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate. Arzerra is also approved as extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL in the U.S. In the European Union, Arzerra is approved for use in combination with chlorambucil or bendamustine for the treatment of patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy. In more than 50 countries worldwide, Arzerra is also indicated as monotherapy for the treatment of patients with CLL who are refractory after prior treatment with fludarabine and alemtuzumab.

Arzerra is not approved anywhere in the world in combination with fludarabine and cyclophosphamide as treatment for relapsed CLL.

Please see full Prescribing Information, including Boxed WARNING for Arzerra (ofatumumab).
Arzerra is marketed under a collaboration agreement between Genmab and Novartis. Novartis also has rights to develop ofatumumab in autoimmune indications, including multiple sclerosis.

Opdivo® (nivolumab) Granted First Approval of a PD-1 Inhibitor in Hematology for the Treatment of Classical Hodgkin Lymphoma Patients Who Have Relapsed or Progressed After Auto-HSCT and Post-transplantation Brentuximab Vedotin by the FDA1

On May 17, 2016 Bristol-Myers Squibb Company (NYSE:BMY) reported that the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) for the treatment of patients with classical Hodgkin lymphoma (cHL) who have relapsed or progressed after autologous hematopoietic stem cell transplantation (auto-HSCT) and post-transplantation brentuximab vedotin (Press release, Bristol-Myers Squibb Company, MAY 17, 2016, View Source [SID:1234512497]).1

This accelerated approval is based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. This first approval of a PD-1 inhibitor for cHL patients who have relapsed or progressed after auto-HSCT and post-transplantation brentuximab vedotin is based on a combined analysis of data from the Phase 2 CheckMate -205 and the Phase 1 CheckMate -039 trials.1 Based on this analysis (n=95), Opdivo delivered a high response rate, with an objective response rate (ORR) of 65% (CI 95%: 55-75; 62/95 patients).1 The percentage of patients with a complete response was 7% (CI 95%: 3-15; 7/95 patients), and the percentage of patients with a partial response was 58% (CI 95%: 47-68; 55/95 patients).1 Among responders, the duration of response was maintained over time for a median of 8.7 months (CI 95%: 6.8-NE; range 0.0+, 23.1+).1

Opdivo is associated with the following Warnings and Precautions including immune-mediated: pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, rash, encephalitis, other adverse reactions; infusion reactions; complications of allogeneic HSCT after Opdivo; and embryo-fetal toxicity.1 Please see the Important Safety Information section below.

"As a classical Hodgkin lymphoma patient who has tried multiple therapies, I know firsthand what it’s like to not have a clear next step," said Matt Kludt, a patient enrolled in a nivolumab clinical trial. "When I started on Opdivo, I was hopeful about the potential for this new treatment. Now, I’m proud to be able to say I was one of several patients who have helped contribute to the approval of a new therapy that may offer other patients like me the possibility of a high response rate."

"Today’s approval of Opdivo delivers a transformational and exciting new option for these patients and the hematologists who treat them. By expanding this Immuno-Oncology therapy into a hematologic malignancy, we continue to deliver upon our unwavering commitment to provide treatments that work directly with the body’s immune system for patients who are in need of new options," said Chris Boerner, Head of U.S. Commercial, Bristol-Myers Squibb. "This is our second Immuno-Oncology agent in blood cancer in less than a year for patients impacted by diseases with a deep unmet need. This approval of Opdivo represents how we are continually working towards the goal of helping patients, like Matt, by offering them a new chance in their fight against this disease."

The efficacy of Opdivo in patients (n=95) with cHL after failure of auto-HSCT and post-transplantation brentuximab vedotin was evaluated in the combined analysis from two studies.1 CheckMate -205 is a Phase 2, single-arm, open-label, multicenter, multicohort study.1 The results of this trial will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2016. CheckMate -039 is a Phase 1, open-label, multicenter, dose escalation study.1 In the combined analysis, efficacy was evaluated by ORR, and an additional outcome measure was duration of response. Objective response rate was assessed by an independent radiographic review committee.1

Both studies excluded patients with an Eastern Cooperative Oncology Group (ECOG) performance status of two or higher, autoimmune disease, symptomatic interstitial lung disease, hepatic transaminases more than three times the upper limit of normal (ULN), creatinine clearance less than 40 mL/min, prior allogeneic HSCT or chest irradiation within 24 weeks.1 In addition, both studies required an adjusted diffusion capacity of the lungs for carbon monoxide (DLCO) of more than 60% in patients with prior pulmonary toxicity.1 Patients received 3 mg/kg of single-agent Opdivo administered as an intravenous infusion over 60 minutes every two weeks until disease progression, maximal clinical benefit or unacceptable toxicity.1

The median age was 37 years (range: 18-72), and the majority were male (64%) and white (87%).1 Patients had received a median of five prior systemic regimens (range: 3-15) and received a median of 17 doses of Opdivo (range: 3-48), with a median duration of therapy of 8.3 months (range: 1.9-24 months).1 In adults with cHL who have relapsed or progressed after auto-HSCT and post-transplantation brentuximab vedotin (n=95), Opdivo demonstrated impressive response rates: ORR was 65% (CI 95%: 55-75; 62/95 patients), including a 7% complete response rate (CI 95%: 3-15; 7/95 patients) and a 58% partial response rate (CI 95%: 47-68; 55/95 patients).1 The median time to response was 2.1 months (range: 0.7-5.7).1 Among responders, Opdivo demonstrated an 8.7 month median duration of response (95% CI: 6.8-NE; range 0.0+, 23.1+).1

The safety of Opdivo in cHL was evaluated in 263 adult patients from the CheckMate -205 (n=240) and -039 (n=23) trials.1 Among these patients (safety population: n=263) serious adverse reactions occurred in 21% of patients.1 The most frequent serious adverse reactions reported in ≥1% of patients were infusion-related reaction, pneumonia, pleural effusion, pyrexia, rash and pneumonitis.1 Ten patients died from causes other than disease progression, including 6 who died from complications of allogeneic HSCT.1 In the safety population, 4.2% discontinued treatment due to adverse reactions, and 23% of patients had a dose delay for an adverse reaction.1 In the subset of patients in the efficacy population (n=95), serious adverse reactions occurred in 27% of the patients.1 In CheckMate -205 and -039, among all patients (safety population: n=263) and the subset of patients in the efficacy population (n=95), respectively, the most common adverse reactions (reported in at least 20%) were fatigue (32% and 43%), upper respiratory tract infection (28% and 48%), pyrexia (24% and 35%), diarrhea (23% and 30%), and cough (22% and 35%).1 In the subset of patients in the efficacy population (n=95), the most common adverse reactions also included rash (31%), musculoskeletal pain (27%), pruritus (25%), nausea (23%), arthralgia (21%), and peripheral neuropathy (21%).1

"It is important to have new treatment options for patients with difficult-to-treat diseases who have exhausted the current available options. Because of the unique pathology and biology of classical Hodgkin lymphoma,2 it makes sense from a scientific standpoint to investigate a PD-1 inhibitor," said Anas Younes, M.D., medical oncologist and chief of Lymphoma Service, Memorial Sloan Kettering Cancer Center. "The recent clinical data with Opdivo in patients with classical Hodgkin lymphoma who have relapsed or progressed after auto-HSCT and post-transplantation brentuximab vedotin is encouraging and has the potential to impact our approach to treating these individuals in the future."

About Classical Hodgkin Lymphoma

Hodgkin lymphoma (HL), also known as Hodgkin disease, is a cancer that starts in white blood cells called lymphocytes, which are part of the body’s immune system.3 Approximately 8,500 new cases of HL are estimated to be diagnosed in 2016.3 More than 1,100 deaths from HL are expected this year. According to the Lymphoma Research Foundation, cHL is the most common type of HL, accounting for 95% of cases.4 In this type of HL, cancer cells are called Reed-Sternberg cells, an abnormal type of B lymphocyte.3

South Korea is first to approve next generation lung cancer treatment olmutinib (BI 1482694 / HM61713)

On May 17, 2016 Boehringer Ingelheim reported that Olmutinib* (BI 1482694 / HM61713) has been approved in South Korea for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer, who had been previously treated with an EGFR tyrosine kinase inhibitor (TKI) (Press release, Boehringer Ingelheim, MAY 17, 2016, View Source [SID:1234512496]).

The approval represents a first for regulatory authorities in South Korea and is a major breakthrough for patients. The compound will be distributed in South Korea by Hanmi Pharmaceutical Co. Ltd under the name olmutinib.

This approval is based on the results of the Phase I/II HM-EMSI-101 [NCT01588145 (link is external)] clinical trial which showed promising clinical activity for olmutinib (BI 1482694 / HM61713):1

Among 69 patients evaluable for response, objective response was observed by independent assessment in 62% of patients, including 32 (46%) whose tumour response had been confirmed at the time of data cut-off, 30 June 2015
Disease control rate was 91% by independent assessment
Majority of treatment-related adverse events (AEs) were mild-to-moderate and the most common included diarrhoea, nausea, rash and skin itching
Professor Keunchil Park, Director of Innovative Cancer Medicine Institute (ICMI) at Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea commented, "The approval of olmutinib is a great step forward for lung cancer patients in South Korea. This is an exciting and much needed new treatment option for the majority of EGFR mutation-positive lung cancer patients whose disease has become resistant to first-line TKI therapy, which can be a devastating development."

Olmutinib (BI 1482694 / HM61713) is a novel third-generation, oral, EGFR mutation-specific TKI. It is currently in accelerated development through the ambitious ELUXA clinical trial programme with the aim to submit data and evidence to the US FDA and EU EMA in 2016. The pivotal Phase II trial ELUXA 1 (HM-EMSI-202 [NCT02485652 (link is external)]) is ongoing, enrolling EGFR T790M mutation-positive lung cancer patients who have become resistant to previous TKI treatment.

Dr Jörg Barth, Corporate Senior Vice President, Therapy Area Head Oncology, Boehringer Ingelheim said, "This first approval of olmutinib is an exciting milestone for the compound and we are working diligently to make this novel treatment option globally available to patients and physicians as quickly as possible."

Boehringer Ingelheim and Hanmi Pharmaceutical Co. Ltd signed an exclusive license agreement in 2015 providing the German pharmaceutical company with worldwide exclusive rights except in South Korea, China and Hong Kong. ZAI Lab has secured exclusive rights in China (including Hong Kong and Macau).

Intended audiences
This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

Notes to editors
About olmutinib (BI 1482694)
Olmutinib (BI 1482694) is a novel third-generation, orally active, irreversible EGFR mutant-specific TKI. It is currently being investigated for the treatment of patients with advanced and metastatic EGFR mutation-positive NSCLC, whose tumours acquired T790M-mediated resistance to initial EGFR TKI treatment. The compound will be further investigated in the ELUXA pivotal trial programme which will include the initiation of Phase III studies in 2016. The trial programme will research the potential of the compound as a monotherapy and in combination with other potent treatments. Olmutinib (BI 1482694) has demonstrated promising clinical activity, combined with a favourable safety profile in a Phase I/II clinical trial (HM-EMSI-101).1

About lung cancer
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About Boehringer Ingelheim in Oncology
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