On November 7, 2019 Accelerate Diagnostics, Inc. (Nasdaq: AXDX) reported financial results for the third quarter ended September 30, 2019 (Press release, ACCELERATED MEDICAL DIAGNOSTICS, NOV 7, 2019, View Source [SID1234550781]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"Our placement and revenue results for the third quarter came in below our expectations due to an elongated sales cycle and the timing of commercial go-lives during the quarter," said Larry Mehren, president and chief executive officer of Accelerate Diagnostics, Inc. "However, we saw several encouraging signs of improvement during the quarter, including a record number of go-lives in September, an increasingly robust sales funnel and continued progress with our respiratory trial and in China. As momentum in placements and go-lives continues to improve, we remain on pace to achieve the low end of our 300-400 placement target. Looking ahead, we acknowledge the need for greater consistency and predictability in our results, and we are focused on improving our commercial execution under Jack Phillip’s leadership, as we continue our pursuit of bringing Accelerate’s life-saving technology to as many patients as possible worldwide."

Third Quarter 2019 Highlights

Added 37 net new commercially contracted instruments, compared to 29 in the third quarter of 2018.
Net sales of $2.3 million, compared to $1.4 million in the third quarter of 2018. Instrument revenue decreased year-over-year, reflecting the Company’s introduction of a reagent rental business model in September of 2018. Consumable revenue grew by over 175% as compared to the third quarter of 2018 and by approximately 15% over the prior quarter.
Gross margin was 51% for the quarter, compared to 50% in the third quarter of 2018. This small increase was the result of lower consumable production costs per unit as production volumes increase.
Selling, general, and administrative expenses for the quarter were $12.7 million, compared to $12.2 million in the third quarter of 2018. This increase was driven by higher non-cash equity-based compensation expense.
Research and development (R&D) costs for the quarter were $6.1 million, compared to $7.9 million in the third quarter of 2018. This decrease was the result of lower employee non-cash equity-based compensation expense.
Net loss was $20.4 million in the third quarter, or $0.37 per share, which included $3.1 million in non-cash stock-based compensation expense.
Net cash used in the quarter was $15.9 million, and the company ended the quarter with total cash, investments, and cash equivalents of $122.0 million.
Year-to-Date 2019 Highlights

Added 167 net new commercially contracted instruments year to date, compared to 69 for the same period from 2018.
Net sales of $5.8 million, compared to $3.8 million for the same period from 2018. Consumable revenue grew by over 150% through the first three quarters of 2019, compared to the same period in the prior year.
Gross margin was 50%, compared to 51% for the same period from 2018. This small decrease was the result of inventory timing items that did not repeat in the current year. After normalizing for the effect of these pre-FDA instrument inventory previously written off to R&D, gross margin improved by 500 basis points year-to-date due to higher consumable production levels.
Selling, general, and administrative expenses were $38.3 million year to date, compared to $41.8 million for the same period from 2018. This decrease was driven by lower stock-based compensation expense in the current year.
Research and development (R&D) costs were $19.1 million year to date, compared to $20.7 million for the same period from 2018. This decrease was the result of lower employee non-cash equity-based compensation expense.
Net loss was $63.0 million year to date, or $1.16 per share, which included $9.4 million in non-cash stock-based compensation expense.
Net cash used year to date was $44.5 million, and the company ended the quarter with total cash, investments, and cash equivalents of $122.0 million.
Full financial results for the quarter ending September 30, 2019 will be filed on Form 10-Q through the Securities and Exchange Commission’s (SEC) website at View Source

Audio Webcast and Conference Call

The company will host a conference call at 4:30PM ET today to review its first quarter results. To participate in the conference call, dial +1.877.883.0383 and enter the conference ID: 2508360. International participants may dial +1.412.902.6506. Please dial in 10 to 15 minutes prior to the start of the conference call. A replay of the call will be available by telephone at +1.877.344.7529 (U.S.) or +1.412.317.0088 (international) using replay code 10136055 until November 28, 2019.

This conference call will also be webcast and can be accessed from the "Investors" section of the company’s website at axdx.com/investors. A replay of the audio webcast will be available until November 28, 2019.

On November 7, 2019 LIDDS AB (publ) Jiangxi Puheng Pharma reported that it has after reviewing the preliminary results in LPC-004 decided to move ahead and has initiated discussions with Chinese medical authority, CFDA (Press release, Lidds, NOV 7, 2019, View Source [SID1234555902]). The phase III study protocol will be developed in close collaboration with LIDDS.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

LIDDS signed in 2018 an exclusive license agreement for Liproca Depot for Mainland China with Jiangxi Puheng Pharma, a company focusing on oncology and immuno-oncology. Liproca Depot, is an injectable cancer drug candidate for local treatment of prostate cancer. LIDDS is with Liproca Depot targeting patients under Active Surveillance with intermediate risk of progression, a patient group that are not getting surgery or radiation.

Jiangxi Puheng Pharma is a Chinese pharmaceutical company specializing in global collaborations and in-licensing. LIDDS received a signing fee exceeding USD 1 million in 2018 which will be followed by milestone payments and royalty on sales as long as NanoZolid patents are valid, currently until 2037. The phase III clinical trial will be conducted in urology clinics in China and will be fully financed by the Jiangxi Puheng Pharma. LIDDS and Jiangxi Puheng will work closely together to optimize time to market for launching Liproca Depot in China.

The prostate cancer market is growing in China with around 500 000 patients being diagnosed annually. Puheng expects that the sales of Liproca Depot will reach yearly sales of 50 000 to 70 000 treatments five years after launch.

Jiangxi Puheng views NanoZolid technology and specifically the Liproca Depot product as a very promising treatment for prostate cancer.

We are very pleased to receive the positive Phase IIb results and we have already started preparations for conducting the Liproca Depot clinical trial in China. We hope to extend the partnership with LIDDS and get other products based on the NanoZolid technology into our pipeline, says Mr. Dai Dai, CEO of Jiangxi Puheng.
Liproca Depot will benefit prostate cancer patients both in terms of efficacy and maintained quality of life. Prostate cancer is a fast-growing cancer disease in China, why research and development in this field is of great importance. We are pleased that Jiangxi Puheng already has decided to progress with the phase III trial in China, says Monica Wallter, CEO, LIDDS.
Jiangxi Puheng has its own regulatory and clinical departments and a highly recognized marketing and sales organization. Being deeply connected with the Chinese regulatory authorities and key clinical opinion leaders, their sales network covers 1,130 large scale public hospitals and an additional 4,592 hospitals in China. The sales team has launched four different drug products with an annual revenue of more than RMB 1.5 billion each and three drug products with revenues of RMB 1 billion respectively.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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.