On November 7, 2019 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 third quarter ended September 30, 2019 (Press release, Navidea Biopharmaceuticals, NOV 7, 2019, View Source [SID1234550637]).

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"During the third quarter, Navidea continued to deliver on the Company’s initiatives to complete the NAV 3-31 Phase 2B trial in patients with Rheumatoid Arthritis ("RA")," said Mr. Jed A. Latkin, Chief Executive Officer of Navidea. "The Company furthered its partnership discussions around the globe, and most importantly, met its internal enrollment goals for the ongoing RA trials. We also achieved several key milestones in Navidea’s clinical pipeline, and continue to advance programs in the therapeutics division. Navidea remains focused on potentially bringing its RA diagnostic to market within the next 18 to 24 months."

Third Quarter 2019 Highlights and Subsequent Events

Continued with double-digit subject enrollment in the Company’s NAV3-31 Phase 2b study in rheumatoid arthritis ("RA").

Announced positive results of the first interim analysis of the NAV3-31 Phase 2b study, demonstrating that Tc99m tilmanocept imaging can provide robust, quantitative imaging in healthy controls and in patients with active RA, and that this imaging is stable, reproducible, and can define joints with and without RA-involved inflammation.

Entered into a collaboration agreement with IMV Inc., a clinical-stage immuno-oncology company, to explore the combinatory effect of Navidea’s and IMV’s proprietary immuno-oncology platforms.

Received the Notice of Award from the National Heart, Lung and Blood Institute for the Small Business Technology Transfer Phase 1 grant application that will support a collaboration with the University of Alabama at Birmingham titled "Gallium 68 Tilmanocept for PET Imaging of Atherosclerosis Plaques", with studies set to begin shortly.

Completed patient enrollment in NAV3-24, the NIH-funded imaging trial in Kaposi Sarcoma patients titled, "An Evaluation of the Safety of Escalating Doses of Tc 99m Tilmanocept by Intravenous (IV) Injection and a Comparison to Subcutaneous (SC) Injection in Human Immunodeficiency Virus (HIV) Subjects Diagnosed with Kaposi Sarcoma (KS)".

Continued enrollment in the Investigator Initiated Phase 2 trial being run at the Massachusetts General Hospital evaluating Tc 99m tilmanocept uptake in atherosclerotic plaques of HIV-infected individuals.

Michael Rosol, Chief Medical Officer for Navidea, said, "The clinical research team has been working diligently to advance the technology in key disease areas, with an emphasis on our ongoing RA trials. We continue to advance our Phase 2B trial in RA, building upon the recently announced interim analysis results, and are planning ahead for the Phase 3 trial."

Financial Results

Navidea’s consolidated balance sheets, statements of operations, and statements of stockholders’ equity have been restated, as required, for all periods presented to reflect the April 2019 reverse stock split as if it had occurred on January 1, 2018. The consolidated statements of cash flows were not impacted by the reverse stock split.

Total revenues for the third quarter of 2019 were $237,000, compared to $231,000 in the same period of 2018. Total revenues for the first nine months of 2019 were $539,000, compared to $1.1 million in the same period of 2018. The year-to-date decrease was primarily due to a decrease in license revenue related to the sublicense of the Company’s NAV4694 technology, which included a non-refundable upfront payment in 2018, coupled with a reduction in grant revenue related to Small Business Innovation Research grants from the National Institutes of Health supporting Manocept development.

Research and development ("R&D") expenses for the third quarter of 2019 were $1.8 million, compared to $1.2 million in the same period of 2018. R&D expenses for the first nine months of 2019 were $3.6 million, compared to $3.4 million in the same period of 2018. The year-to-date increase was primarily due to net increases in drug project expenses, which includes Manocept diagnostic and Tc99m tilmanocept development costs, offset by decreased Manocept therapeutic and NAV4694 development costs. The net increase in R&D expenses also included decreased compensation costs resulting from net decreased salaries and headcount.

Selling, general and administrative ("SG&A") expenses for the third quarter of 2019 were $1.5 million, compared to $2.7 million in the same period of 2018. SG&A expenses for the first nine months of 2019 were $5.1 million, compared to $6.2 million in the same period of 2018. Decreased compensation, primarily related to the resignation of the former CEO in 2018, coupled with net decreased related support costs such as director compensation, general office expenses and taxes, were offset by increased legal and professional services, primarily related to the Goldberg litigation.

Navidea’s net loss attributable to common stockholders for the third quarter of 2019 was $3.1 million, or $0.17 per share, compared to a net loss attributable to common stockholders of $3.8 million, or $0.46 per share, for the same period in 2018. Navidea’s net loss attributable to common stockholders for the first nine months of 2019 was $8.2 million, or $0.62 per share, compared to a net loss attributable to common stockholders of $13.0 million, or $1.58 per share, for the same period in 2018.

Navidea ended the third quarter of 2019 with $2.8 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:

Q3 2019 Earnings and Business Update Conference Call

Date:

Thursday, November 7, 2019

Time:

5:00 p.m. (EST)

U.S. & Canada Dial-in:

877-407-0312

International Dial-in:

+1 201-389-0899

Conference ID:

13696379

Webcast Link: View Source

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.

On November 7, 2019 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer and other indications, reported that the Company will host an R&D event in New York on Tuesday, November 19, 2019 from 12:00 – 3:30 PM EST (Press release, Pieris Pharmaceuticals, NOV 7, 2019, View Source [SID1234550653]).

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The R&D event will feature presentations from management and thought leaders in immuno-oncology and respiratory diseases, including:

Michael A. Curran, PhD, Associate Professor, Department of Immunology and Scientific Director, ORBIT Platform, The UT MD Anderson Cancer Center
Geoffrey Y. Ku, MD, Assistant Attending Physician and Head, Esophagogastric Section, Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering
Anuradha Ray, PhD, Professor of Medicine, Department of Immunology and UPMC Endowed Chair in Lung Immunology Medicine, University of Pittsburgh
Sally E. Wenzel, MD, Professor of Medicine, Department of Medicine; Chair, Department of Occupational & Environmental Health; Acting Director, Asthma Environmental Lung Health Institute and UPMC Endowed Chair of Translational Airway Biology, University of Pittsburgh
Presentations will include expert discussant perspectives on recently presented data for PRS-343 and PRS-060, emerging data from the ongoing PRS-343 combination trial with atezolizumab, and perspectives on how these drug candidates could best fit into the emerging landscapes of asthma and immuno-oncology.

The event will be accessible via a live webcast through this link beginning at 12:30 PM EST on November 19, 2019.

In-person attendance is by invitation only. For more information, please contact [email protected].

On November 7, 2019 Renowned South Korean healthcare company, Yuhan Pharmaceuticals (Yuhan) and Cyclica Inc. (Cyclica), a leading neo biotechnology company reported a collaboration to apply Cyclica’s proprietary AI-integrated drug discovery platform in two separate R&D programs (Press release, YuHan, NOV 7, 2019, View Source [SID1234550669]). Yuhan is keen on implementing innovative technologies to enhance drug development efforts and will utilize Cyclica’s unique end-to-end AI-integrated drug discovery platform across diverse therapeutic areas to develop novel advanced lead-like molecules with desired chemical properties against the targets of interest determined by Yuhan’s R&D priorities.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Yuhan will leverage Cyclica’s integrated drug discovery platform, Ligand DesignTM and Ligand Express to generate novel chemical entities with desired polypharmacological, physicochemical, and ADMET properties while providing insights into systems biology and structural pharmacogenomics.

Cyclica will receive an upfront payment as well as receive milestone payments upon the completion of specific objectives. Through this collaboration, Yuhan and Cyclica envision a long-term relationship to enhance future R&D and drug discovery efforts to identify novel solutions for unaddressed therapeutic needs.

Yuhan CEO and President Jung Hee Lee said, "We are very pleased to be collaborating with Cyclica to apply its proprietary AI-integrated drug discovery platform in our R&D programs, and hope to expand our partnership upon the success of the collaboration. Yuhan is dedicated to offering first-in-class to the patients within a short time by applying new computational methods, including AI and Big Data that can shorten the time and the cost required for drug development."

"It’s an honour to collaborate with Yuhan, a visionary company that is thinking deeply about the future of the discovery of better medicines, and the application of new computational methods, including machine and deep learning. I am confident that this collaboration, and the future relationship with Yuhan and Cyclica will benefit patients waiting for new and better medicines." said Naheed Kurji, President and CEO of Cyclica.

On November 7, 2019 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, is reported it has been accepted for a poster presentation at the 61st Annual American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting, which takes place from 7-10 December 2019 in Orlando, Florida (Press release, BerGenBio, NOV 7, 2019, View Source [SID1234550702]).

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The poster will provide an update on its phase II study of bemcentinib (BGB324) in combination with Low-dose Cytarabine in elderly AML patients.

Abstract titles have been announced online. Details of the presentation are below.

Title: Durable responses observed in elderly AML patients unfit for intensive chemotherapy with first-in class selective AXL inhibitor bemcentinib (BGB324) in combination with LDAC: Phase II open-label study

Date: Monday 9th December 2019

Session Name: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster III

Time, Location: 6:00 PM – 8:00 PM, Orange County Convention Center, Hall B

About AXL

AXL kinase is a cell membrane receptor and an essential mediator of the biological mechanisms underlying life-threatening diseases. In cancer, AXL suppresses the body’s immune response to tumours and drives cancer treatment failure across many indications. AXL inhibitors, therefore, have potential high value at the centre of cancer combination therapy, addressing significant unmet medical needs and multiple high-value market opportunities. Research has also shown that AXL mediates other aggressive diseases.

About bemcentinib

Bemcentinib (formerly known as BGB324), is a potentially first-in-class selective AXL inhibitor in a broad phase II clinical development programme. Ongoing clinical trials are investigating bemcentinib in multiple solid and haematological tumours, in combination with current and emerging therapies (including immunotherapies, targeted therapies and chemotherapy), and as a single agent. Bemcentinib targets and binds to the intracellular catalytic kinase domain of AXL receptor tyrosine kinase and inhibits its activity. Increase in AXL function has been linked to key mechanisms of drug resistance and immune escape by tumour cells, leading to aggressive metastatic cancers.

On November 7, 2019 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported financial results for the third quarter ended September 30, 2019 and provided a corporate update (Press release, Jounce Therapeutics, NOV 7, 2019, View Source [SID1234550718]).

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"We have continued to work diligently on advancing our pipeline and further executing on our clinical development plans through our Translational Science Platform and reverse translational analysis. Both of our clinical-stage programs, vopratelimab and JTX-4014, continue to progress well. We are pleased to be presenting both new data from JTX-4014, as well as the dosing and sequencing strategy for vopratelimab in our ongoing EMERGE Phase 2 trial, at the SITC (Free SITC Whitepaper) 2019 Annual Meeting this weekend," said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. "We continue to focus on the underlying mechanistic science of our immunotherapies as we work towards bringing meaningful and long-lasting benefits to cancer patients. We look forward to executing on several key milestones in 2020 across our robust pipeline."

Clinical Programs:
Vopratelimab

Two development paths established for vopratelimab program: The reverse translational analysis from the ICONIC trial established the correlation between ICOS hi CD4 T cells, which emerged due to vopratelimab, and clinical benefit. The first development path focuses on the biology of optimizing the induction of ICOS hi CD4 T cells prior to vopratelimab administration. The second path focuses on the use of a predictive biomarker to identify and select patients who may be more likely to benefit from a combination of vopratelimab and a PD-1 inhibitor. The first of the induction studies, EMERGE, is underway.
Dosing and sequencing strategy for EMERGE Phase 2 trial to be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper): On November 9, 2019, Jounce will present a Trials in Progress poster on the EMERGE trial, which will include the combination dosing and sequencing strategy based on its understanding of the kinetics of induction of ICOS hi CD4 T effector cells by ipilimumab and their expansion and sustained activation by vopratelimab. The EMERGE Phase 2 clinical trial began enrollment in mid-June 2019. Jounce expects to report EMERGE data including preliminary efficacy and biomarker relationships to clinical outcomes for up to 80 patients in 2020.
Predictive biomarker approach: In the second development path, Jounce will focus on the use of a predictive biomarker. In the analysis of ICONIC patients, Jounce was able to identify a biomarker from baseline samples that correlated with the emergence of ICOS hi CD4 T cells, ORR, PFS and OS, in patients treated with vopratelimab alone or in combination with nivolumab. Jounce plans to use this potential predictive biomarker to select patients in a new trial with vopratelimab and JTX-4014. Jounce will provide more details in the next few months on this clinical trial.
JTX-4014

New safety and preliminary efficacy data from JTX-4014 Phase 1 trial to be presented at SITC (Free SITC Whitepaper): On November 8, 2019, Jounce will present new safety and preliminary efficacy data from the Phase 1 trial of JTX-4014 during a poster session at the SITC (Free SITC Whitepaper) 2019 Annual Meeting.
JTX-4014 identified as combination agent: Based on the encouraging safety and preliminary efficacy data, Jounce plans to use JTX-4014 as the PD-1 inhibitor in combination with its other product candidates, including in the new predictive biomarker trial with vopratelimab.
Discovery Pipeline:

On track to announce next development candidate: Jounce continues to advance and develop its broad discovery pipeline, which includes multiple programs targeting T-regulatory cells, macrophages and stromal cells. Jounce expects to move its next novel program into IND-enabling studies by the end of the year.
Corporate Highlights:

Senior appointments: During the third quarter of 2019, Jounce announced the addition of Jacqui Fahey Sandell to its management team as Chief Legal Officer and Corporate Secretary. In October, Haley Laken, Ph.D., VP of Program and Portfolio Strategy, who has been with Jounce since early 2018, also joined the management team.
Third Quarter 2019 Financial Results:

Cash position: As of September 30, 2019, cash, cash equivalents and investments were $185.1 million, compared to $195.9 million as of December 31, 2018. The decrease in cash, cash equivalents and investments was primarily due to operating costs incurred during the period, offset by the $50.0 million license fee received in July 2019 pursuant to Jounce’s new license agreement with Celgene.
License and collaboration revenue: License and collaboration revenue was $119.4 million for the third quarter of 2019, compared to $14.5 million for the same period in 2018. License and collaboration revenue recognized during the third quarter of 2019 was comprised of $50.0 million of cash revenue related to Jounce’s new license agreement with Celgene and $69.4 million of non-cash revenue recognition relating to the $225.0 million upfront payment received in July 2016 upon the execution of Jounce’s original strategic collaboration with Celgene. In connection with the termination of the original strategic collaboration, Jounce recognized the remaining deferred revenue relating to this agreement in the third quarter of 2019. License and collaboration revenue recognized during the third quarter of 2018 was comprised solely of non-cash revenue recognition related to the $225.0 million upfront payment.
Research and development expenses: Research and development expenses were $15.1 million for the third quarter of 2019, compared to $16.8 million for the same period in 2018. The decrease in research and development expenses was primarily due to $2.2 million of decreased external research and development costs attributable to vopratelimab manufacturing expenses and JTX-4014 IND-enabling expenses incurred during the third quarter of 2018. This decrease was partially offset by $0.9 million of increased employee compensation costs.
General and administrative expenses: General and administrative expenses were $6.5 million for both the third quarter of 2019 and the same period in 2018.
Net income (loss): Net income was $98.9 million for the third quarter of 2019, resulting in basic net income per share of $2.99 and diluted net income per share of $2.90. This increase in net income was primarily attributable to $119.4 million of license and collaboration revenue recognized under Jounce’s agreements with Celgene. Net loss was $7.6 million for the same period in 2018, or a basic and diluted net loss per share of $0.23.
Financial Guidance:

Based on its operating and development plans for the remainder of 2019, Jounce now expects gross cash burn on operating expenses and capital expenditures for the full year 2019 to be approximately $75.0 million to $85.0 million, a decrease from its previously announced guidance of approximately $80.0 million to $95.0 million for the full year 2019.

Conference Call and Webcast Information:

Jounce Therapeutics will host a live conference call and webcast today at 8:00 a.m. ET. To access the conference call, please dial (866) 916-3380 (domestic) or (210) 874-7772 (international) and refer to conference ID 3379867. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of Jounce’s website at www.jouncetx.com. The webcast will be archived and made available for replay on Jounce’s website approximately two hours after the call and will be available for 30 days.