On March 23, 2022 iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of highly differentiated immuno-oncology therapeutics for patients, reported financial results for the fourth quarter and full year ended December 31, 2021 and provided recent corporate highlights (Press release, iTeos Therapeutics, MAR 23, 2022, View Source [SID1234610910]).

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"In 2021, we laid a strong foundation for both of our differentiated clinical-stage immunotherapy programs EOS-448, our FcγR-engaging anti-TIGIT antibody, and inupadenant, our adenosine A2A receptor antagonist. The data we shared over the course of the year validates our excitement around both candidates as potentially differentiated therapies capable of harnessing the immune system to improve outcomes for patients with several types of advanced cancers," said Michel Detheux, Ph.D., president and chief executive officer of iTeos. "Anticipating the advancement of both EOS-448 and inupadenant from early to late-stage clinical development with novel combinations, we have built a global team to fuel the execution of our robust clinical development plans throughout 2022. This year is expected to be critical in terms of data generation for the TIGIT and adenosine fields, and we’re excited to play a key role in growing the body of evidence that will inform how these targets can be harnessed for patients as safely and quickly as possible."

Program Highlights

EOS-448: IgG1 anti-TIGIT monoclonal antibody designed to engage the Fc gamma receptor (FcγR) and to enhance the anti-tumor response through multifaceted mechanisms.

In collaboration with GSK, iTeos is initiating various combinations to advance this next generation immuno-oncology agent:
Began dosing in a Phase 1b clinical trial in patients with non-small cell lung cancer (NSCLC) assessing the doublet of GSK’s anti-PD-1 (Jemperli) with EOS-448.
Planning three registration-directed trials combining EOS-448 with Jemperli in 1L NSCLC PDL1 high, head and neck squamous cell carcinoma (HNSCC) and a third indication targeting an additional immune-responsive tumor.
Initiating Phase 1b trials with novel triplets, including Jemperli with EOS-448 and inupadenant in patients with advanced solid tumors and EOS-448 with Jemperli and GSK’s investigational anti-CD96 antibody in patients with NSCLC.
iTeos is evaluating the doublets of pembrolizumab with EOS-448 and inupadenant with EOS-448 in patients with solid tumors in an ongoing Phase 1 trial.
In December 2021, favorable preclinical data generated in collaboration with Fred Hutchinson Cancer Research Center were presented at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition. Based on this data, iTeos is advancing an open-label dose-escalation/expansion Phase 1/2 trial of EOS-448 as a monotherapy and in combination with Bristol Myers Squibb’s iberdomide – a novel, potent oral cereblon E3 ligase modulator (CELMoD) with or without dexamethasone, in adults with relapsed or refractory multiple myeloma.
The company will present preclinical and clinical analyses supporting the multifaceted mechanism of action of EOS-448, including data on pharmacodynamics within the tumor microenvironment, as part of a late-breaking poster presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place April 8-13, 2022 in New Orleans, Louisiana.
Inupadenant (EOS-850): Designed as an insurmountable and highly selective small molecule antagonist of the adenosine A2A receptor, the only high-affinity adenosine receptor expressed on different immune cells found in the tumor micro-environment.

iTeos is initiating a randomized Phase 2 trial to evaluate the combination of inupadenant with chemotherapy compared to standard of care in an undisclosed solid tumor indication.
The Company is also evaluating inupadenant in combination with pembrolizumab in PD-1 resistant melanoma in an ongoing Phase 2a trial
iTeos is evaluating patient and indication selection biomarkers in an ongoing Phase 1b/2a trial of inupadenant as a monotherapy in patients with solid tumors.
Preclinical programs: Building on the company’s successful track record of advancing differentiated programs from discovery into the clinic, iTeos continues to progress research programs focused on additional targets that address pathways of immunosuppression. In 2021, iTeos nominated an additional candidate targeting a new mechanism in the adenosine pathway for Investigational New Drug-enabling studies.

Upcoming Events

AACR Annual Meeting, April 8-13, 2022
Late-Breaking Abstract Title: Pharmacodynamic assessment of a-TIGIT mAb EOS-448 highlights multiple FcγR-mediated mode-of-actions in blood and tumor of patients with advanced solid tumors; Wednesday, April 13 from 9:00am – 12:30pm CDT
Session Title: Late Breaking Research: Experimental and Molecular Therapeutics 2
Abstract Number: LB189 / Section 16
Fourth Quarter and Full Year 2021 Financial Results

Cash Position: The Company’s cash and cash equivalent position was $848.5 million as of December 31, 2021, as compared to $336.3 million as of December 31, 2020. Cash balance provides runway into 2026.
Research and Development (R&D) Expenses: R&D expenses were $17.4 million for the quarter and $59.4 million for the full year ended December 31, 2021, as compared to $9.2 million for the fourth quarter and $29.9 million for the full year of 2020. The increase was primarily due to an increase in activities related to clinical trials for EOS-448 and Inupadenant, as well as preclinical programs.
General and Administrative (G&A) Expenses: G&A expenses were $9.6 million for the quarter and $40.5 million for the full year ended December 31, 2021, as compared to $5.7 million for the fourth quarter and $15.3 million for the full year of 2020. The increase was primarily due to an increase in professional fees related to the Company’s collaboration with GSK, in addition to an increase in professional fees associated with the Company’s status as a publicly traded company.
Net Income/Loss: Net income attributable to common shareholders was $184.9 million, or a net income of $5.24 per basic share and $4.88 per diluted share, for the quarter ended December 31, 2021, as compared to a net loss of $14.9 million, or a net loss of $0.43 per basic and diluted share, for the fourth quarter of 2020. Net income was $214.5 million, or a net income of $6.10 per basic share and $5.68 per diluted share, for the year ended December 31, 2021, as compared to a net loss of $43.4 million, or a net loss of $2.88 per basic and diluted share, for the full year of 2020.

On March 23, 2022 Histogen Inc. (NASDAQ: HSTO), a clinical-stage company focused on developing potential first-in-class restorative therapeutics that ignite the body’s natural process to repair and maintain healthy biological function, reported that it has entered into a securities purchase agreement with certain institutional investors to purchase 2,500 shares of Series A redeemable convertible preferred stock and 2,500 shares of Series B redeemable convertible preferred stock (Press release, Conatus Pharmaceuticals, MAR 23, 2022, View Source [SID1234610984]). Each share of Series A and Series B preferred stock has a purchase price of $952.38, representing an original issue discount of approximately 5% of the $1,000 stated value of each share. Each share of Series A and Series B preferred stock is convertible into shares of Histogen’s common stock at an initial conversion price of $1.00 per share. Shares of the Series A and Series B preferred stock are convertible at the option of the holder at any time following the Company’s receipt of stockholder approval for an amendment to the Company’s certificate of incorporation that allows the Company to effectuate a reverse stock split of the Company’s common stock. Histogen will be permitted to compel conversion of the Series A and Series B preferred stock after the fulfillment of certain conditions and subject to certain limitations. Total net proceeds from the offerings, before deducting the placement agent’s fees and other estimated offering expenses, is approximately $4.75 million.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The Series A and Series B preferred stock permit the holders thereof to vote together with the holders of the Company’s common stock on a proposal to effect a reverse stock split of the Company’s common stock at an annual or special meeting of Company stockholders. The Series A preferred stock permits the holder to vote on such proposal on an as-converted to common stock basis based on the minimum price under Nasdaq rules on the issuance date. The Series B preferred stock permits the holder to cast 30,000 votes per share of Series B preferred stock on such proposal. The Series A and Series B preferred stock will not be permitted to vote on any other matter. The holders of the Series A and B preferred stock agreed not to transfer their shares of preferred stock until after the stockholder meeting. The holders of the Series A preferred stock agreed to vote their shares on the reverse stock split proposal and the holders of the Series B preferred stock agreed to vote their shares on such proposal in the same proportions as the shares of common stock and Series A preferred stock are voted on such proposal. The holders of the Series A and Series B preferred stock have the right to require the Company to redeem their shares of preferred stock for cash at 105% of the stated value of such shares commencing after the earlier of the Company’s stockholders’ approval of the reverse stock split and 90 days after the closing of the issuances of the Series A and Series B preferred stock and until 120 days after such closing.

The closing of the offering is expected to occur on or about March 25, 2022, subject to the satisfaction of customary closing conditions. Additional information regarding the securities described above and the terms of the offering are included in a Current Report on Form 8-K to be filed with the United States Securities and Exchange Commission ("SEC").

To the extent Series A or B preferred stock is converted or otherwise not redeemed after 120 days from closing, the Company will use such net proceeds from this offering for working capital and general corporate purposes.

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and the securities have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. Under an agreement with the investors, the Company agreed to file an initial registration statement with the Securities and Exchange Commission (the "SEC") covering the resale of the shares of common stock issuable upon conversion of the preferred stock no later than July 20, 2022, and to use commercially reasonable efforts to have the registration statement declared effective as promptly as practical thereafter, and in any event no later than September 18, 2022 (or October 18, 2022, in the event of a "full review" of the registration statement by the SEC).

This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state.

On March 23, 2022 Applied DNA Sciences, Inc. (NASDAQ: APDN), a leader in cell-free, enzymatic DNA production, reported that CEO Dr. James A. Hayward is invited to present at the 2022 Virtual Growth Conference presented by Maxim Group LLC and hosted by M-Vest, on March 28th – 30th from 9:00 a.m. – 5:00 p.m. EDT (Press release, Applied DNA Sciences, MAR 23, 2022, View Source [SID1234610708]). Dr. Hayward’s presentation will be available on-demand for the duration of the conference via the sign-up link: Sign up here to access the presentation

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During the virtual conference, investors will hear from executives from a wide range of sectors, including Biotech, Clean Energy, Electric Vehicles, Financial Services, Fintech & REITS, Gaming & Entertainment, Healthcare, Healthcare IT, Infrastructure, Shipping and Technology/ Media/Telecom. The conference will feature company presentations, fireside chats, roundtable discussions, and live Q&A with CEOs moderated by Maxim Research Analysts.

This conference will be live on M-Vest. To attend, sign up to become an M-Vest member: Click Here to Reserve your seat

On March 23, 2022 Recursion (Nasdaq: RXRX), the clinical-stage biotechnology company industrializing drug discovery by decoding biology, reported business updates and financial results for its fourth quarter and fiscal year ending December 31, 2021 (Press release, Recursion Pharmaceuticals, MAR 23, 2022, View Source [SID1234610767]).

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Recursion Pipeline Programs
"2021 was an exciting year for Recursion, in which we closed one of the largest biotechnology initial public offerings in history; expanded our partnership with Bayer; entered into a transformational partnership with Roche and Genentech; received Fast Track and Orphan Drug Designations from the FDA for our NF2 and FAP programs, respectively; readied several programs to initiate clinical trials; expanded our therapeutics pipeline with numerous programs in oncology; and built and began to utilize our supercomputer, BioHive1," said Recursion Co-Founder & CEO Chris Gibson, Ph.D. "As we applied our mapping and navigating capabilities to explore complex biology, we discovered and advanced many new scientific and business opportunities. We are excited for 2022 as we work to transition more biology and chemistry from maps to medicines."

Summary of Business Highlights

Clinical Programs
Cerebral cavernous malformation (CCM) (REC-994): In March 2022, we enrolled the first patient in our Phase 2 SYCAMORE clinical trial, which is a double-blind, placebo-controlled safety, tolerability and exploratory efficacy study of this drug candidate in 60 subjects with CCM.
Neurofibromatosis type 2 (NF2) (REC-2282): We plan to initiate our Phase 2/3 POPLAR-NF2 clinical trial, which is a parallel group, two stage, randomized, multicenter study of this drug candidate in the second quarter of 2022.
Familial adenomatous polyposis (FAP) (REC-4881): We plan to initiate a Phase 2, randomized, double-blind, placebo-controlled study to evaluate safety, pharmacokinetics and efficacy of this drug candidate in the third quarter of 2022.
Preclinical and Discovery Programs
Clostridium difficile colitis (REC-3964): We made progress in IND-enabling studies for REC-3964 and plan to initiate a Phase 1 study in the second half of 2022.
Small molecule inhibitor of a target with a novel link to CDK12 biology: A small molecule inhibitor of a novel target not otherwise known to be related to CDK12, discovered using our next generation mapping and navigating technology, has demonstrated robust single-agent and combination activity with olaparib in an HRD-negative ovarian cancer PDX model, achieving 100% complete and durable response.
Cancer immunotherapy target ‘alpha’: We expanded the in vivo dataset of target alpha, where a small molecule inhibitor of target alpha, discovered using our next generation mapping and navigating technology, demonstrated robust combination activity with an anti-PD1 therapy in an EMT6 mouse model and achieved 80% complete response.
Oncology pipeline: We continued to make progress expanding and advancing numerous oncology programs, discovered using our next generation mapping and navigating technology, through scientific milestones including the programs mentioned above as well as programs related to immune checkpoint resistance in STK11-mutant non-small cell lung cancer, small molecule MYC inhibition, cancer immunotherapy target ‘beta,’ hepatocellular carcinoma, ovarian cancer, and other indications.
Roche-Genentech Collaboration: In early December 2021, we announced a transformational collaboration with Roche and Genentech to advance novel potential medicines in neuroscience and an indication in gastrointestinal oncology by mapping complex biology using the Recursion OS. In this collaboration, Recursion received an upfront payment of $150 million in January 2022, is eligible for milestones for map-building and data-sharing that could exceed $500M, as well as research and development, commercialization and net sales milestones on up to 40 programs that could exceed $300M per program and mid- to high-single digit tiered royalties on net sales for products commercialized from this work together.
Bayer AG Collaboration: In early December 2021, we announced the expansion of our collaboration with Bayer to include the use of Recursion’s biological mapping and navigating capabilities to discover small molecule drug candidates with the potential to treat fibrotic diseases. In this expanded collaboration, Recursion and Bayer may now work on more than a dozen programs of relevance to fibrotic diseases.
Recursion OS
Closed Loop Automated Synthesis Suite (CLASS): We began designing CLASS, our automated chemical microsynthesis system, which will further enable novel chemical formulation and profiling across our maps of biology and chemistry.
Total Observations: In the fourth quarter of 2021, we surpassed the milestone of executing 100 million total phenotypic experiments and producing 1 billion proprietary biological images.
Fourth Quarter and Fiscal Year 2021 Financial Results

Cash Position: Cash, cash equivalents, and investments were $516.6 million as of December 31, 2021, compared to $262.1 million as of December 31, 2020. This cash balance does not include the upfront payment of $150 million from entering into the Roche-Genentech collaboration in December 2021, which was received in January 2022.
Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $2.5 million for the fourth quarter of 2021, compared to $2.7 million for the fourth quarter of 2020. Total revenue, consisting primarily of revenue from collaboration agreements, was $10.2 million for the year ended December 31, 2021, compared to $4.0 million for the year ended December 31, 2020. The increase in 2021 was due to revenue recognized from our collaboration with Bayer.
Research and Development Expenses: Research and development expenses were $48.3 million for the fourth quarter of 2021, compared to $20.7 million for the fourth quarter of 2020. Research and development expenses were $135.3 million for the year ended December 31, 2021, compared to $63.3 million for the year ended December 31, 2020. The increases in both periods in 2021 were primarily due to an increased number of experiments run on the Recursion OS, an increased number of assets being validated, and increased clinical costs of studies to progress our drug candidates.
General and Administrative Expenses: General and administrative expenses were $19.2 million for the fourth quarter of 2021, compared to $7.6 million for the fourth quarter of 2020. General and administrative expenses were $57.7 million for the year ended December 31, 2021, compared to $25.3 million for the year ended December 31, 2020. The increases in both periods in 2021 were due to the growth in size of the company’s operations, including an increase in salaries and wages of $16.4 million during the year ended December 31, 2021, equipment costs, human resources-related costs, facilities costs, and other administrative costs associated with operating as a high-growth company.
Net Loss: Net loss was $64.9 million for the fourth quarter of 2021, compared to a net loss of $25.8 million for the fourth quarter of 2020. Net loss was $186.5 million for the year ended December 31, 2021, compared to a net loss of $87.0 million for the year ended December 31, 2020.
Additional Corporate Updates

Letter to Shareholders: Recursion Co-Founder & CEO Chris Gibson, Ph.D. wrote an annual letter to shareholders which may be found in our 10-K report filed with the SEC.
Environmental, Social, and Governance (ESG) Report: Recursion has prepared a report which describes our operations in relation to a number of ESG metrics. A copy of this report may be found on the Recursion website at www.Recursion.com.
Neuroscience: Tim Ahfeldt, Ph.D. joined Recursion as Fellow, Neuroscience; Irit Rappley, Ph.D. joined Recursion as Vice President, Neuroscience and Translational Research; and Glenn Morrison, Ph.D. joined Recursion as Vice President, Clinical Development.
Clinical Development: Rogelio Mosqueda-Garcia, M.D., Ph.D. joined Recursion as Vice President, Clinical Development & Head of Human Pharmacology and Translational Medicine and Lisa Boyette, M.D., Ph.D. was promoted to Vice President, Medical Affairs.
Chemical Technology & Manufacturing: David Northrup joined Recursion as Vice President, Manufacturing & Supply Chain and Thierry Masquelin, Ph.D. joined Recursion as Senior Director, Chemical Technology.
Intellectual Property: Rich Person, J.D. joined Recursion as Vice President, Intellectual Property.
Annual Shareholder Meeting: The Recursion Annual Meeting of Shareholders will be held on June 14, 2022.

On March 23, 2022 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 year-to-date for the period ended December 31, 2021 (Press release, Navidea Biopharmaceuticals, MAR 23, 2022, View Source [SID1234610840]).

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Alexander L. Cappello, Chair of Navidea’s Board of Directors, said, "We remain focused on our mission of developing precision immunodiagnostic agents and immunotherapeutics to enhance patient care. We are confident that our strong management team, supported by our experienced and active Board of Directors, can continue to execute on our business plan and fulfill the vision we have for Navidea."

Fourth Quarter 2021 Highlights and Subsequent Events

●Continued to work on financing for the Company. We have engaged with an investment bank and options are being pursued.

●Initiated and enrolled into the Company’s NAV3-33 Phase 3 trial in rheumatoid arthritis ("RA") titled "Evaluation of Tc 99m Tilmanocept Imaging for the Early Prediction of Anti-TNFα Therapy Response in Patients with Moderate to Severe Active Rheumatoid Arthritis."

●Continued enrollment into the Company’s NAV3-32 Phase 2b trial comparing Tc99m tilmanocept imaging to histopathology of joints of patients with active RA. Eleven patients out of an originally estimated maximum of 24 based on subject pathotype are now enrolled with both imaging and biopsy performed.

●Completed enrollment in the Company’s NAV3-35 Phase 2b study, "Development of a Normative Database for Rheumatoid Arthritis (RA) Imaging with Tc99m Tilmanocept."

●Completed the investigator-initiated Phase 2 trial being run at the Massachusetts General Hospital evaluating Tc99m tilmanocept uptake in atherosclerotic plaques of HIV-infected individuals. An abstract was presented at the Conference on Retroviruses and Opportunistic Infections in February 2022.

●Signed research agreement with the University of Pennsylvania evaluating Tc99m tilmanocept as a prognostic marker for glioblastoma.

●Signed a Letter of Intent with the image analysis company MIM Software, Inc., to be the Company’s commercial partner for image quantification of Tc99m tilmanocept imaging in RA.

●Filed two new provisional patent applications. The first is related to new methods of attaching chemotherapeutics to the Manocept platform, and the second relates to maximizing target-tissue uptake and off-target competitive blocking. These have important implications for pipeline applications.

Michael Rosol, Ph.D., Chief Medical Officer for Navidea, said, "The clinical research team continues to work diligently to advance the technology in key disease areas, with an emphasis on our RA program. The NAV3-33 Phase 3 trial is enrolling, we continue to enroll into the NAV3-32 Phase 2b trial comparing tilmanocept imaging to synovial tissue biopsy samples of RA patients, and we have completed our normative database trial enrollment. Concurrent with all of this, we continue to make progress in our therapeutics pipeline, and we expect to keep advancing these towards the clinic."

Financial Results

●Total net revenues for the fourth quarter of 2021 were $50,000, compared to $219,000 for the same period in 2020. Total net revenues for the full year of 2021 were $532,000, compared to $914,000 in 2020. The decrease was primarily due to decreased grant revenue related to Small Business Innovation Research grants from the National Institutes of Health supporting Manocept development and decreased royalty and license revenue from sales of Tc99m tilmanocept in Europe, offset by the partial recovery of debts previously written off in 2015 and receipt of reimbursement from Cardinal Health 414, LLC of certain R&D costs.

●Research and development ("R&D") expenses for the fourth quarter of 2021 were $1.4 million, compared to $1.3 million in the same period in 2020. R&D expenses for the full year of 2021 were $5.1 million, compared to $4.9 million in 2020. The net increase during the year to date was primarily due to increased regulatory consulting, employee compensation, travel, recruiting and general office expenses, coupled with net increases in drug project expenses, including increased Manocept therapeutic and Tc99m tilmanocept development costs, offset by decreased Manocept diagnostic development costs.

●Selling, general and administrative ("SG&A") expenses for the fourth quarter of 2021 were $2.3 million, compared to $1.7 million in the same period in 2020. SG&A expenses for the full year of 2021 were $7.5 million, compared to $6.7 million in 2020. The net increase during the year to date was primarily due to separation expenses related to the resignation of our former Chief Executive Officer, coupled with increased consulting services related to European distribution of Tc99m tilmanocept, director compensation related to additional board members and increased board compensation rates, insurance costs, losses on the abandonment of certain intellectual property, recruiting fees, travel and general office expenses, offset by decreases in legal and professional services, employee compensation, investor relations costs, European annual registration fees, facilities costs and franchise taxes.

●Navidea’s net loss attributable to common stockholders for the fourth quarter of 2021 was $3.7 million, or $0.12 per share, compared to $3.0 million, or $0.11 per share, for the same period in 2020. Navidea’s net loss attributable to common stockholders for the full year of 2021 was $11.7 million, or $0.40 per share, compared to $11.4 million, or $0.48 per share, in 2020.

●Navidea ended the fourth quarter of 2021 with $4.2 million in cash and cash equivalents.

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. Dr. Michael Rosol, Chief Medical Officer, and Erika Eves, Vice President of Finance and Administration, will host the call and webcast to discuss the financial results and provide an update on recent developments and clinical progress. Management will be available to answer questions live immediately following the earnings announcement and prepared remarks portion of the call.

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.