On March 11, 2020 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics to treat cancer, reported an expanded research collaboration with Cancer Research UK and the University of Manchester, UK, to develop small molecule inhibitors of Poly(ADP-ribose) glycohydrolase (PARG) (Press release, Ideaya Biosciences, MAR 11, 2020, View Source [SID1234555417]). PARG is a cellular enzyme that hydrolyzes Poly (ADP-ribose) polymerase (PARP), a protein function required for DNA repair.

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Since initiating the Cancer Research UK partnership in 2017, IDEAYA has developed a selective and cell potent PARG small molecule series, that demonstrates robust on-target in vivo pharmacodynamic modulation. In 2019, Dr. Stephen Taylor and Pilay et. al., published a paper in Cancer Cell, entitled "DNA Replication Vulnerabilities Render Ovarian Cancer Cells Sensitive to Poly(ADP-Ribose) Glycohydrolase Inhibitors", which provides a potentially differentiated and complementary treatment approach to PARP inhibitors.

The expanded research collaboration will evaluate IDEAYA’s PARG inhibitors in vitro in multiple ovarian cancer cell lines and in vivo in ovarian cancer xenograft models. Dr. Stephen Taylor, B.Sc., Ph.D., Leech Professor of Pharmacology, University of Manchester, the principal investigator at University of Manchester, will lead the in vitro investigations. Dr. Caroline Springer, Ph.D., Director, Drug Discovery Unit, Cancer Research UK Manchester Institute, the principal investigator at the Cancer Research UK Manchester Institute, will lead the in vivo studies.

"We are excited to expand our partnership with IDEAYA to evaluate key biological hypotheses based on DNA replication vulnerabilities to predict sensitivity of PARG inhibitors in ovarian cancer. A large percentage of ovarian cancer patients still do not respond to PARP inhibitors, and there is an important need to advance other synthetic lethality DDR-based targets," said Dr. Stephen Taylor, B.Sc., Ph.D. "This collaborative research builds on our existing relationship with IDEAYA, and could potentially inform effective patient selection strategies of PARG inhibitors," added Dr. Caroline Springer, Ph.D.

"Cancer Research UK has made important research contributions to the DNA Damage Repair and PARP-BRCA synthetic lethality field, and we are delighted to expand our partnership with this leading cancer research institute to advance our potential first-in-class PARG inhibitor program," said Yujiro S. Hata, Chief Executive Officer and President, IDEAYA Biosciences.

On March 11, 2020 Tiziana Life Sciences plc (NASDAQ: TLSA) (AIM: TILS) (the "Company" or "Tiziana"), a U.S. and U.K. biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology, reported the pricing of its underwritten follow-on public offering (the "Offering") of American Depositary Shares ("ADSs") on the NASDAQ Global Market (Press release, Tiziana Life Sciences, MAR 11, 2020, View Source [SID1234555433]). Tiziana will issue 3,333,333 ADSs (representing 16,666,665 new ordinary shares of nominal value £0.03 each in the capital of the Company ("Ordinary Shares")) at a price to the public of $3.00 per ADS raising gross proceeds of approximately $10 million (before deducting underwriting discount, commissions and offering expenses). Each ADS offered represents five (5) Ordinary Shares. In addition, Tiziana has granted the underwriters a 45-day option to purchase up to an additional 500,000 ADSs on the same terms and conditions (the "Option"). All ADSs to be sold in the Offering will be offered by the Company. The number of Ordinary Shares represented by ADSs comprised in the Offering (including by way of the exercise of the Option) will be within existing shareholder authorities.

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ThinkEquity, a division of Fordham Financial Management, Inc., is acting as the sole book-running manager for the Offering.

The closing of the Offering is expected to occur on March 16, 2020, subject to customary closing conditions.

Tiziana intends to use the net proceeds received from this Offering (i) to advance the clinical development of Foralumab for Crohn’s Disease and progressive multiple sclerosis, (ii) to expedite clinical development of TZLS-501 for coronavirus COVID-19, and (iii) for working capital and other general corporate purposes.

Tiziana’s Ordinary Shares are admitted to trading on AIM, a market of the London Stock Exchange plc ("AIM"), under the symbol "TILS". The ADSs are listed for trading on the Nasdaq Global Market under the symbol "TLSA".

This Offering is being made pursuant to a registration statement on Form F-3, as amended (File No. 333-236013), previously filed with the U.S. Securities and Exchange Commission (the "SEC"), which became effective on February 6, 2020.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. A preliminary prospectus supplement and accompanying base prospectus relating to this offering have been filed with the SEC and are available at the SEC’s website at View Source Before investing in Tiziana’s securities, you should read the preliminary prospectus supplement and the accompanying base prospectus and the documents incorporated by reference therein for information about Tiziana and this Offering. A final prospectus supplement related to the Offering will also be filed with the SEC.

Copies of the final prospectus supplement and accompanying prospectus relating to the offering, when available, may be obtained from ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673, by email at [email protected]. Electronic copies of the final prospectus supplement and accompanying prospectus will also be available on the SEC’s website at View Source

In conformity with DTR 5.6.1, the Company notifies that as at the date of this announcement, it has a single class of shares in issue being Ordinary Shares and that following the issue of the Ordinary Shares to be issued in the Offering (excluding any to be issued pursuant to the Option), the total number of Ordinary Shares in issue will be 153,321,181. There are no Ordinary Shares held in treasury. Each Ordinary Share entitles the holder to a single vote at general meetings of the Company.

Application will be made to the London Stock Exchange for the Ordinary Shares to be admitted to trading on AIM ("Admission"). Admission is expected to occur on or around 17 March 2020.

The figure of 153,321,181 Ordinary Shares may be used by shareholders (and others with notification obligations) as the denominator for the calculations by which they will determine whether they are required to notify their interest in, or a change to their interest in, the Company under the Financial Conduct Authority’s Disclosure Guidance and Transparency Rules.

Following admission of the Ordinary Shares to be issued in the Offering (excluding any to be issued pursuant to the Option), the fully diluted issued share capital of the Company will consist of 179,148,059 Ordinary Shares.

The person who arranged for the release of this announcement on behalf of the Company was Tiziano Lazzaretti, Chief Financial Officer of Tiziana.

On March 11, 2020 LifeArc has reported that leading UK venture capital firm UK Innovation & Science Seed Fund (UKI2S) in investing into GyreOx Therapeutics (GyreOx) (Press release, LifeArc, MAR 11, 2020, View Source [SID1234555418]). The funding will support a two-year programme to develop and automate GyreOx’s proprietary drug discovery platform, MACRO.

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The MACRO platform generates a range of highly modified macrocyclic peptide molecules, known as gyrocycles, which can penetrate cells and be targeted to tackle the protein-protein interactions (PPI) within. These intracellular processes are potentially implicated in many health conditions including cancer, inflammation and autoimmune diseases and are difficult to reach with currently available medicine classes. Automation of the MACRO platform will enhance the generation process further to allow a greater number of novel macrocycles to be generated more quickly and more cheaply.

Dr Bill Primrose, Founder and CEO of GyreOx said: "It’s a strong endorsement of our technology that we have been able to attract support from such quality investors. We have an ambitious plan to develop the platform and to deploy it on a number of internal programmes, including one targeting an epigenetic cancer target. It is our ambition to make GyreOx into a clinical stage company with a strong drug pipeline and a number of discovery alliances with major players in the pharmaceutical industry."

Common medicines classes include small molecules and biologics. While small molecules can enter cells to modulate intracellular process, they have difficulty in addressing complex targets, including PPIs. Biologics, such as humanised antibodies, are unable to enter the cell and are therefore only suitable for addressing drug targets on the cell surface. GyreOx’s Gyrocycle highly modified macrocyclic peptides combine the targeting ability of biologics with the cell-entry ability of small molecules; these molecules present an attractive, novel therapeutic modality as they can also be engineered to further improve their pharmacokinetic profile and ability to penetrate cells to reach previously "undruggable" targets.

Dr David Holbrook, Head of Seed Fund, LifeArc said: "The LifeArc Seed Fund is delighted to be supporting GyreOx on its work on the macrocycles platform and helping translate the science on the next step towards the patient. GyreOx is a great example of the type of company we are trying to support—great science, great scientists, strong start up management all addressing a significant unmet health need."

GyreOx Ltd. was founded in May 2019 as a result of the ground-breaking science carried out by Professor James Naismith (University of Oxford, previously at the University of St Andrews) and Professor Marcel Jaspars (University of Aberdeen). This seed investment has been led by UKI2S with LifeArc as the major investor and a contribution from Oxford University’s University Challenge Seed Fund. Part of the investment will also provide match funding for an Innovate UK grant to GyreOx.

Oliver Sexton, Investment Director UKI2S said: "GyreOx can design truly novel compounds with the ability to target intracellularly. This opens up a whole new drug space. UKI2S is excited to back such groundbreaking and medically important research."

On March 11, 2020 BioLife Solutions, Inc. (NASDAQ: BLFS) ("BioLife" or the "Company"), a leading developer and supplier of a portfolio of best-in-class bioproduction tools for cell and gene therapies, reported financial results and operational highlights for the fourth quarter and full year ended December 31, 2019 (Press release, BioLife Solutions, MAR 11, 2020, View Source [SID1234555434]).

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Mike Rice, BioLife CEO, commented, "2019 saw a remarkable transition for BioLife, as we transformed the business from a single product company to a multi-solution provider of class-defining bioproduction tools to the cell and gene therapy industry.

We posted record revenue of $27.4 million and record adjusted EBITDA of $5.7 million, driven by our 2019 acquisitions, which we believe confirms that our strategy to innovate and consolidate in this highly-fragmented industry is bearing fruit. In 2019, we gained nearly 200 new customers and confirmed our biopreservation media products were spec’d into 69 additional clinical trials. Our customer base includes most of the leading and late stage cell and gene therapy companies and with our 2019 acquisitions, we are currently serving a majority of the companies in the space with at least one product in our bioproduction tools portfolio. In addition to our products being embedded in the commercial shipments of YESCARTA and ZOLGENSMA, at least one of our portfolio products is spec’d into seven additional cell or gene therapies that could gain approval in 2020.

We believe that we have a tremendous opportunity to expand our product offering and grow revenue organically and from additional acquisitions of other innovative tools providers."

2019 M&A Recap

April: Astero Bio; automated, water-free thawing products for biologic source material and manufactured cell and gene therapy products
August: SAVSU Technologies; class-defining cloud-connected, evo shipping containers and a SaaS for cold chain management of biologic source material and manufactured cell and gene therapy products
November: Custom Biogenic Systems (CBS); high capacity controlled rate freezers, liquid nitrogen storage tanks and related accessories
Revenue Highlights for the Fourth Quarter and Full Year 2019

Total revenue for the fourth quarter of 2019 increased to $8.3 million compared with $5.5 million for the fourth quarter of 2018, a year-over-year gain of 52%.
Total revenue for the year 2019 increased to $27.4 million compared with $19.7 million for the year 2018, a year-over-year gain of 39%.
Biopreservation media revenue was $5.2 million for the fourth quarter of 2019, a decrease of 5% compared with the fourth quarter of 2018. Two customers ordered $1 million less than their Q4 forecasts; the first was a direct cell therapy customer whose production demand was lower, so they consumed existing media inventory. The other was a large distributor. Despite this shortfall, revenue from this distributor was up 76% vs. 2018, and they shipped our media products to more than 1,700 customers in 2019. For the full year 2019, media revenue was $23.4 million, an increase of 18% over 2018. Two direct clinical stage customers were down $2.5 million vs. 2018. Excluding these two customers, our remaining biopreservation media customer revenue grew 44% over 2018.
Automated thaw revenue was $480,000 and $1.2 million for the fourth quarter and full year of 2019, respectively. Over 300 units of the ThawSTAR vial products have been shipped since the acquisition in April 2019.
evo revenue was $481,000 and $692,000 for the fourth quarter and full year of 2019, based on 4.5 months of BioLife’s ownership. For 2019, over 1,000 worldwide shipments were made and tracked utilizing the evo liquid nitrogen dewar and evo SaaS application.
Freezer revenue resulting from the November acquisition of CBS, totaled $2.1 million for the fourth quarter.
Additional Financial Highlights for the Fourth Quarter and Full Year 2019

GROSS MARGIN

Gross margin (GAAP) for the fourth quarter of 2019 was 62% compared with 69% in the fourth quarter of 2018. Adjusted gross margin (non-GAAP) for the fourth quarter was 65%.
Gross margin (GAAP) for the year 2019 was 68% compared with 69% for the year 2018. Adjusted gross margin (non-GAAP) for the year 2019 was 69%.
OPERATING EXPENSES

Operating expenses (GAAP) for the fourth quarter of 2019 were $6.3 million compared with operating expenses of $2.7 million for the fourth quarter of 2018. Adjusted operating expenses (non-GAAP) were $5.5 million for the fourth quarter of 2019.
Operating expenses (GAAP) for the year 2019 were $18.8 million compared with operating expenses of $9.9 million for the year 2018. Adjusted operating expenses (non-GAAP) were $17.1 million for 2019.
OPERATING INCOME/(LOSS)

Operating loss (GAAP) for the fourth quarter of 2019 was $1.2 million compared with operating income of $1.0 million for the fourth quarter of 2018. Adjusted operating loss (non-GAAP) was $163,000 for the fourth quarter.
Operating loss (GAAP) for the year 2019 was $336,000 compared with operating income of $3.7 million for the year 2018. Adjusted operating income (non-GAAP) for the year 2019 was $1.8 million.
NET INCOME/LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS

Net income attributable to common stockholders (GAAP) for the fourth quarter of 2019 was $481,000 compared with net income of $833,000 for the fourth quarter of 2018. Adjusted net loss (non-GAAP) was $74,000 for the fourth quarter of 2019 compared with $1.1 million in the fourth quarter of 2018.
Net income attributable to common stockholders (GAAP) for the year 2019 was $11.1 million, compared with a net income of $2.9 million for the year 2018. Adjusted net income (non-GAAP) for the year 2019 was $2.3 million compared with $3.6 million.
EARNINGS/(LOSS) PER SHARE

Earnings per share (GAAP) for the fourth quarter of 2019 were $0.02 on a fully diluted basis compared to earnings of $0.03 on a fully diluted basis for the fourth quarter of 2018. Adjusted EPS (non-GAAP) was zero on a fully diluted basis for the fourth quarter of 2019 compared with $0.04 in the fourth quarter of 2018.
Earnings per share (GAAP) for the year 2019 were $0.42 on a fully diluted basis compared to earnings of $0.12 on a fully diluted basis for the year 2018. Adjusted EPS (non-GAAP) was $0.08 on a fully diluted basis for 2019 compared with $0.15 in 2018.
EBITDA

EBITDA, a non-GAAP financial measure, for the fourth quarter of 2019 was negative $191,000 compared with positive $768,000 for the fourth quarter of 2018. Adjusted EBITDA (non-GAAP) for the fourth quarter of 2019 was $1.4 million compared with $1.5 million for the fourth quarter of 2018.
EBITDA, a non-GAAP financial measure, for the year 2019 was $10.8 million compared with $3.0 million for the year 2018. Adjusted EBITDA (non-GAAP) for the year 2019 was $5.7 million compared to $5.5 million in 2018.
2020 Financial Guidance

Our financial guidance for the full year 2020 is based on expectations for our existing business, and does not include any additional M&A activity, or any potential impact of COVID-19.

Revenue for 2020 is expected to be in the range of $48 million to $53 million, reflecting year-over-year revenue growth of 75% to 94%. Media revenue is expected to grow between 20% to 30% over 2019, and account for approximately 55% of total revenue. Freezer sales are expected to account for approximately 35% of total revenue, with automated thaw and evo product lines each accounting for approximately 5% of total revenue. We expect revenue in the first half of the year to represent 40% of the years total, with the remaining 60% realized in the second half of the year.
Gross margin for 2020 is expected to be in the range of 58% to 62%.
Operating expenses for 2020 are expected to be in the range of $28 to $30 million, which includes $2.8 million of intangible asset amortization expense.
We expect positive 2020 operating profit, net income and EBITDA, on a GAAP and non-GAAP basis. We expect to exit 2020 with an adjusted EBITDA (non-GAAP) margin of 20% to 25%.
Potential Impact of COVID-19 Coronavirus

The Seattle area, including the location of our corporate headquarters and our media production facility and warehouse, is currently the epicenter of the coronavirus outbreak in the US. We are following the recommendations of local health authorities to minimize exposure risk for our team members and visitors. We believe we have sufficient inventory to meet previously forecasted biopreservation media demand for the next six to nine months, and we are implementing various business continuity plans to reduce the potential impact of COVID-19. However, this is a dynamic situation, with an unknowable magnitude and duration. Our focus is on the health of our team members in all locations, and our ability to meet customer demand for our products.

Conference Call & Webcast

The Company will host a conference call and live webcast at 4:30 p.m. Eastern time today. To access the live webcast, please go to www.biolifesolutions.com/earnings/. Alternatively, you may access the live conference call by dialing (844) 825-0512 (U.S. & Canada) or (315) 625-6880 (International) with the following Conference ID: 9098230. A webcast replay will be available approximately two hours after the call and will be archived on www.biolifesolutions.com for 90 days.

On March 11, 2020 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 ended December 31, 2019 (Press release, Navidea Biopharmaceuticals, MAR 11, 2020, View Source [SID1234555419]).

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"During the fourth quarter, Navidea made great strides in its enrollment of the NAV 3-31 Phase 2B trial in patients with rheumatoid arthritis," said Mr. Jed A. Latkin, Chief Executive Officer of Navidea. "The Company continued its dialogue with several key potential partners and we anticipate providing updates on those initiatives in the very near future. Furthermore, with the most recent financing, the Company put in place the steps necessary to launch the next critical trials."

Fourth 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") and completed enrollment of subjects in Arms 1 and 2.

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.

Completed enrollment in NAV3-24, a Phase 1 Kaposi’s Sarcoma trial; All imaging has been completed and the Company is currently compiling results.

Continued enrollment in the Investigator Initiated Phase 2 trial being run at the Massachusetts General Hospital evaluating Tc99m tilmanocept uptake in atherosclerotic plaques of HIV-infected individuals.

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.

Converted the Tilmanocept Uptake Value quantitative imaging analysis provisional patent to an A1 patent application, and filed an additional provisional patent relevant to both imaging and therapeutic applications.

Executed agreements with five investors, including an existing investor, to purchase approximately 2.1 million shares of the Company’s common stock in a private placement for aggregate gross proceeds to Navidea of approximately $1.9 million.

Won summary judgment in the Court of Common Pleas for Franklin County, Ohio (the "Ohio Court") related to the Company’s ongoing litigation with Capital Royalty Partners II, L.P., et al ("CRG"), in the amount of $4.3 million plus interest (the "Judgment"). The Ohio Court also found that there was no unjust enrichment or conversion by CRG. The decision is a final appealable order and terminated the case.

Executed a binding term sheet to sell the Judgment for $4.2 million of proceeds to Navidea.

Executed agreements with two existing investors to purchase approximately 4.0 million shares of the Company’s common stock for aggregate gross proceeds to Navidea of approximately $3.4 million.

Following the funding transactions described above, the Company regained compliance with the NYSE American’s continued listing standards with stockholders’ equity of $6.0 million.

Michael Rosol, Ph.D., 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 last quarter’s announced interim analysis results, and with an eye towards the second interim analysis. We are also planning for the start of our second Phase 2B trial comparing tilmanocept imaging to synovial tissue biopsy samples of RA patients as well as 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 fourth quarters of both 2018 and 2019 were $119,000. Total revenues for fiscal 2019 were $658,000, compared to $1.2 million in 2018. The year-to-year 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 fourth quarter of 2019 were $1.7 million, compared to $854,000 in the same period of 2018. R&D expenses in 2019 were $5.3 million, compared to $4.2 million in 2018. The 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.

Selling, general and administrative ("SG&A") expenses for the fourth quarter of 2019 were $1.2 million, compared to $1.4 million in the same period of 2018. SG&A expenses for 2019 were $6.3 million, compared to $7.7 million in 2018. The decrease was primarily related to the resignation of the Company’s former CEO in 2018, coupled with net decreases in salaries and bonuses, investor relations, general office expenses and taxes, offset by increased legal and professional services, primarily related to litigation with the Company’s former CEO.

Navidea’s net loss attributable to common stockholders for the fourth quarter of 2019 was $2.8 million, or $0.15 per share, compared to a net loss attributable to common stockholders of $3.2 million, or $0.33 per share, for the same period in 2018. Navidea’s net loss attributable to common stockholders for 2019 was $10.9 million, or $0.76 per share, compared to a net loss attributable to common stockholders of $16.1 million, or $1.89 per share, for 2018.

Navidea ended the fourth quarter of 2019 with $1.0 million in cash and investments. Per Navidea’s recent filings with the SEC, the Company executed funding transactions totaling $7.6 million in proceeds during the first quarter of 2020.

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:

Q4 2019 Earnings and Business Update Conference Call

Date:

Wednesday, March 11, 2020

Time:

5:00 p.m. (EDT)

U.S. & Canada Dial-in:

877-407-0312

International Dial-in:

+1 201-389-0899

Conference ID:

13699935

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