On March 24, 2021 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 for the period ended December 31, 2020 (Press release, Navidea Biopharmaceuticals, MAR 24, 2021, View Source [SID1234577074]).

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!

"We are very excited about the progress we have made, completing all the patients in the Phase 2B NAV3-31 trial and submitting our briefing book to the FDA were milestone accomplishments this past year," said Mr. Jed A. Latkin, Chief Executive Officer of Navidea. "We are looking forward to hearing back from the FDA and continuing our due diligence discussions with Jubilant over the near term."

Fourth Quarter 2020 Highlights and Subsequent Events

Announced positive results from continued analysis of subjects who have completed Arm 3 of the Company’s NAV3-31 Phase 2B study. These data further corroborated Navidea’s hypotheses that Tc99m tilmanocept imaging can provide robust, quantitative imaging in patients with active rheumatoid arthritis ("RA") and that this imaging can provide an early indicator of treatment efficacy.
Submitted a formal Type B Meeting Request to the U.S. Food and Drug Administration ("FDA"). The FDA granted the Type B meeting and the Company has submitted the Briefing Book. The FDA is currently reviewing these formal briefing documents containing results from the NAV3-31 Phase 2B study and the proposed Phase 3 design and protocol.
Achieved last patient, last visit in the Company’s NAV3-31 Phase 2B study. Study closeout and data analysis are ongoing.
Opened the first US site, Northwestern University, for enrollment in the Company’s NAV3-32 Phase 2B trial comparing Tc99m tilmanocept imaging to histopathology of joints of patients with active RA.
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.
Received notice of patent grant from the USPTO for US 10,806,803: "Compositions for targeting macrophages and other CD206 high expressing cells and methods of treating and diagnosis."
Received a notice of allowance from the USPTO for the patent application: "Compounds and methods for diagnosis and treatment of viral infections" (US Patent Application 15/729,635).
Performed preclinical studies that demonstrate macrophage phenotype change from an immunosuppressive to a pro-inflammatory state and a synergistic effect on tumor growth reduction using the Company’s doxorubicin-containing construct with an approved checkpoint inhibitor therapy.
Appointed Malcolm G. Witter to the Company’s Board of Directors. Mr. Witter brings decades of financial and corporate governance experience to the board.
Entered into a Stock Purchase Agreement and Letter of Investment Intent with an existing investor, pursuant to which the Company issued to the investor 50,000 shares of newly-designated Series E Redeemable Convertible Preferred Stock (the "Series E Preferred Stock") for an aggregate purchase price of $5.0 million. The Series E Preferred Stock is convertible into a maximum of 2,173,913 shares of Common Stock.
Michael Rosol, Ph.D., Chief Medical Officer for Navidea, said, "The clinical research team is working diligently to advance the technology in key disease areas, with an emphasis on our RA program. We have completed all patients and all visits in our NAV3-31 Phase 2B trial and we are eagerly anticipating feedback from the FDA on our briefing package and design of the Phase 3 trial. We continue to prepare for initiation of this trial and have also opened up enrollment for the NAV3-32 Phase 2B trial comparing tilmanocept imaging to synovial tissue biopsy samples of RA patients. Concurrent with all of this, we have made exciting progress in our therapeutics pipeline and will continue to advance these towards the clinic."

Financial Results

Total net revenues for the fourth quarter 2020 were $219,000, compared to $119,000 for the same period in 2019. Total net revenues for the full year of 2020 were $914,000, compared to $651,000 for 2019. The increases were primarily due to increased grant revenue related to Small Business Innovation Research grants from the National Institutes of Health supporting Manocept development coupled with increased license revenue from net transitional sales in Europe.
Research and development ("R&D") expenses for the fourth quarter of 2020 were $1.3 million, compared to $1.7 million in the same period in 2019. R&D expenses for the full year of 2020 were $4.9 million, compared to $5.3 million in the same period in 2019. The decreases were primarily due to net decreases in drug project expenses, including decreased Manocept therapeutic development costs, decreased Manocept diagnostic development costs, and decreased Tc99m development costs, offset by increased NAV4694 development costs. The net decreases also included decreased regulatory consulting and travel expenses offset by increased employee compensation.
Selling, general and administrative ("SG&A") expenses for the fourth quarter of 2020 were $1.7 million, compared to $1.2 million in the same period in 2019. SG&A expenses for the full year of 2020 were $6.7 million, compared to $6.3 million in 2019. The net increases were primarily due to increased legal and professional services, employee compensation, European Medicines Agency annual fees for Lymphoseek, and franchise taxes, offset by decreased travel, depreciation and amortization, losses on disposal of assets, insurance, and investor relations services.
Navidea’s net loss attributable to common stockholders for the fourth quarter of 2020 was $3.0 million, or $0.11 per share, compared to $2.8 million, or $0.15 per share, for the same period in 2019. Navidea’s net loss attributable to common stockholders for the full year of 2020 was $11.4 million, or $0.48 per share, compared to $10.9 million, or $0.76 per share, for 2019.
Navidea ended the fourth quarter of 2020 with $2.7 million in cash and cash equivalents. Since December 31, 2020, the Company has received $7.9 million of cash related to the Series D and Series E Preferred Stock funding transactions. To date, the Company has received over $14 million of proceeds from the issuance of Series C, Series D and Series E Preferred stock.
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.

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 March 24, 2021 Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders, reported financial results for the fourth quarter and full year 2020, and provided an update on its clinical development programs (Press release, Equillium, MAR 24, 2021, View Source [SID1234577073]).

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!

"It was an exciting year of clinical advancement for Equillium and our lead asset, itolizumab, a first-in-class anti-CD6 monoclonal antibody that selectively targets the CD6-ALCAM pathway," said Bruce Steel, chief executive officer at Equillium. "As the pathway plays a central role in a number of immuno-inflammatory diseases, we think of itolizumab as a pipeline in a product and are currently evaluating the therapeutic in acute graft-versus-host disease, lupus and lupus nephritis, and uncontrolled asthma. While the pandemic caused delays in our clinical studies last year, we look forward to our forthcoming data from all three studies in 2021. We anticipate the data this year will be important for all stakeholders, but none more so than the patients with these severe and life-threatening diseases."

2020 and 2021 Year-to-Date Corporate Highlights:

Raised a total of $83.7 million in financing net proceeds in 2020 and through the registered direct offering completed in February 2021, strengthening Equillium’s balance sheet and extending its expected cash runway into the second half of 2023
Announced positive interim data from EQUATE study in acute graft-versus-host disease (aGVHD)
Presented translational data in aGVHD demonstrating the impact of itolizumab on effector T cell function at the:
Transplantation & Cellular Therapy Meetings of ASTCT & CIBMTR
Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper)
2021 Transplantation and Cellular Therapy Meetings Digital Experience
Presented data at the 2020 American College of Rheumatology Meeting, demonstrating that CD6 modulation improves kidney and skin pathology in preclinical models of systemic lupus erythematosus (SLE)
Presented data at the European Respiratory Society International Congress 2020 demonstrating that the CD6-ALCAM pathway may contribute in multiple ways to asthma pathology
Strengthened leadership and positioned Equillium for organizational growth, including the following additions since the beginning of this year:
Dolca Thomas, M.D., appointed as executive vice president of research and development and chief medical officer
Y. Katherine Xu, Ph.D., partner at Decheng Capital, appointed to Equillium’s board of directors
Upcoming Catalysts:

EQUALISE Phase 1b study: topline data from Type A patients (SLE), 1Q 2021
EQUATE Phase 1b study: topline data in first-line aGVHD, 1H 2021
Regulatory feedback on proposed pivotal study in first-line aGVHD, Mid-2021
Initiate pivotal study in first-line aGVHD, 2H 2021*
EQUALISE Phase 1b study: interim data from Type B patients (lupus nephritis), 2H 2021
EQUIP Phase 1b study: topline data in uncontrolled asthma, 2H 2021
*Proposed protocol & timeline for site initiation contingent on regulatory review

Fourth Quarter and Full Year 2020 Financial Results

Research and development (R&D) expenses for the fourth quarter of 2020 were $6.6 million, compared with $5.4 million for the same period in 2019. The increase in the fourth quarter of 2020 compared to the same period in 2019 was due to greater headcount expenses, greater research and translational science expenses, and an increase in clinical development expenses driven by approximately $0.9 million in expenses incurred in the fourth quarter of 2020 associated with preparing to launch a registrational study in COVID-19 patients, which was discontinued. Those increases were partially offset by a reduction in overhead costs, especially travel, and lower consulting expenses. For the full year of 2020, R&D expenses were $19.4 million, compared with $17.6 million for the same period in 2019. The year-over-year increase in R&D expenses was primarily driven by greater headcount expenses and research expenses, offset by lower overhead costs, especially related to travel and recruiting, and lower total clinical development expenses related to the EQUIP study and the Australian R&D tax incentive credit, partially offset by increases in expenses associated with the EQUALISE study and preparing to initiate a study in COVID-19 patients.

General and administrative (G&A) expenses for the fourth quarter of 2020 were $2.4 million, compared with $2.2 million for the same period in 2019. The increase in the fourth quarter of 2020 compared to the same period in 2019 was due to greater headcount expenses, driven by higher stock-based compensation, and greater consulting expenses, partially offset by a reduction in overhead expenses driven by lower insurance costs. For the full year of 2020, G&A expenses were $10.2 million, compared with $9.1 million for the same period in 2019. The year-over-year increase was primarily due to increased headcount expenses, driven by greater stock-based-compensation but partially offset by lower salary expense, and greater consulting expenses, offset by lower legal costs and overhead expenses, especially related to travel.

Net loss for the fourth quarter of 2020 was $8.9 million, or $(0.36) per basic and diluted share, compared with a net loss of $7.6 million, or $(0.44) per basic and diluted share for the same period in 2019. Net loss for the full year of 2020 was $29.8 million, or $(1.46) per basic and diluted share, compared with a net loss of $25.6 million, or $(1.47) per basic and diluted share for the same period in 2019. The increase in net loss for the full year of 2020 compared to the same period in 2019 was driven primarily by greater operating expenses and to a lesser extent by lower interest income and higher interest expense.

Cash used in operations for the fourth quarter of 2020 was $8.3 million compared to $4.9 million in the third quarter of 2020. Key drivers of the quarter-over-quarter increase in cash used in operations include the resumption in enrollment in the EQUIP and EQUALISE studies following a pause earlier in the year due to COVID-19, payment of directors and officers annual insurance premiums in the fourth quarter, spending in the fourth quarter associated with preparing to launch a registrational study in COVID-19 patients that was discontinued, and a reimbursement from the Australian Taxation Office associated with our 2019 R&D tax incentive claim that was received in the third quarter.

Cash, cash equivalents and short-term investments totaled $82.2 million as of December 31, 2020, compared to $53.1 million as of December 31, 2019. Subsequent to 2020, Equillium further strengthened its balance sheet through the completion of a registered direct offering with Decheng Capital, which raised $29.9 million in net proceeds. Equillium believes that its cash and investments will be sufficient to fund its currently planned operations into the second half of 2023.

About Itolizumab
Itolizumab is a clinical-stage, first-in-class anti-CD6 monoclonal antibody that selectively targets the CD6-ALCAM pathway. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited.

On March 24, 2021 Onxeo S.A. (Euronext Growth: ALONX; Nasdaq First North: ONXEO), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage Response (DDR), in particular against rare or resistant cancers, reported its new dates for the publication of its 2020 annual results and the holding of its annual general meeting (Press release, Onxeo, MAR 24, 2021, View Source [SID1234577072]).

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!

Due to the rights issue that is ongoing until March 31, 2021, the publication of the 2020 annual results will take place on April 21, 2021 after market close and the annual general meeting will be held on June 10, 2021. The date for the publication of the 2021 half-year results, scheduled for July 28 after market close, remains unchanged.

On March 24, 2021 Enveric Biosciences reported that it is one of the sponsors for the Benzinga Biotech Global Small Cap Conference taking place on March 24-25, 2021 (Press release, Enveric Biosciences, MAR 24, 2021, View Source [SID1234577071]). The information contained in this article in no way represents investment advice or opinion on the part of Benzinga or its writers and is intended for informational purposes only.

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!

Chemotherapy is considered one of the most effective ways to battle cancer. However, it comes with side effects that can significantly affect the quality of life of a patient. Although there have been developments to tackle these side effects, today, the many needs of these patients remain unmet.

Enveric Biosciences is targeting these unmet medical needs by using naturally occurring compounds to provide supportive care for cancer patients suffering from the side effects of treatment, such as radiation dermatitis.

Enveric is also developing a product that can target indications such as chemotherapy-induced peripheral neuropathy, with future areas of focus targeting CNS indications such as depression, pain and anxiety.

The company also seeks to advance novel combinations of cannabidiol (CBD) with chemotherapeutic agents. Its preclinical data suggests combination therapies may improve the activity of certain chemotherapies, potentially enabling more potent or longer-lasting therapeutic effects in diseases such as Glioblastoma. These combination therapies may allow greater therapeutic effect with a lower dose of the chemotherapeutic agent, which could minimize the severity of side effects.

Adoption of a Patient-Centric Model
In the world of biotech, most companies have a molecule or a drug delivery platform that they find promising. After they observe the potential of the molecule, they look for a patient population where it can be used.

At Enveric, the model is reversed.

The company looks at patients first and then both internally and through targeted business development look for the most efficacious therapeutics solutions to deal with these challenging indications.

Enveric’s mission is to enhance the quality of life of patients who live with the side effects of cancer treatment using novel therapeutic drugs to create a new standard of care.

Recent News
Raise in Capital

Enveric raised $22.8 million in gross proceeds during the first quarter of 2021. This growth capital — along with zero debt and strong liquidity — creates a well-rounded balance sheet and capitalization structure that allows the company to accelerate its business plans and opportunistically evaluate M&A opportunities such as PureForm and Diverse.

Supply Agreement

On Feb 25, 2021, Enveric announced an exclusive agreement with PureForm Global, a biosciences company focused on the discovery and production of pure cannabinoids for use in treating diseases and promoting wellness. With this agreement, PureForm will supply Enveric with synthetic cannabidiol (CBD) and cannabigerol (CBG) in current good manufacturing practice (cGMP) facilities in the U.S. to look after its supply needs for its clinical trial as well as the potential to collaborate on development opportunities.

License Agreement

Earlier in March, the company acquired an exclusive perpetual license from Diverse Biotech for five molecules, four of which are dermatology-focused and one focuses on pain. The agreement will allow Enveric to expand its development candidates pipeline through CBD conjugation with existing standard-of-care drugs through Diverse Biotech’s advanced chemistry drug delivery platform.

Upcoming Global Small Cap Conference
At Benzinga’s Biotech Small Cap Conference on March 25, David Johnson, Enveric Chairman and CEO will participate on the panel, "The Natural Solutions: Cannabis & Cannabinoids" at 11:40 a.m. EST followed by a corporate presentation at 12:30 p.m. EST.

"Enveric Biosciences is poised for growth with a strong financial base," said Mr. Johnson. "Its key clinical programs are already making progress, aiming to be in the clinic for two indications by the end of 2021. Enveric is focused on advancing its robust pipeline of new-generation, naturally occurring and synthetic compounds that will provide the company with an opportunity to change the standard of care for cancer patients by extending and enhancing patient quality of life."

To catch the latest information from Enveric Biosciences at the upcoming Biotech Small Cap Conference, sign up to participate here.

On March 24, 2021 Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported its financial results for the year ended December 31, 2020 and provided a business update (Press release, Moleculin, MAR 24, 2021, View Source [SID1234577065]).

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!

Recent Milestones and Accomplishments:

Corporate Strategy and Events

Raised gross proceeds of approximately $81 million through registered equity offering and ATM program in 1Q21 providing runway into 2025 based on the Company’s current R&D spending levels. The Company may expand its R&D expenditures to take advantage of new opportunities within its broad pipeline and/or increase the speed of its clinical trials. At a minimum however, the Company intends for current cash levels to support an operating runway through at least 2023.

Next Generation Anthracycline – Annamycin

Received $1.5 million grant to fund a Phase 1b/2 clinical trial for the treatment of soft tissue sarcoma ("STS") lung metastases in Europe

Received FDA IND and ODD for Annamycin against STS; plan to begin a Phase 1b/2 clinical trial in the US for patients after receiving first-line therapy for STS that has metastasized to the lungs

Reached a 2nd dose limiting toxicity (DLT) in March 2021 and plan to establish a maximum tolerable dose (MTD) in our European trial for Annamycin against acute myeloid leukemia (AML); plan to pursue Phase 2 once the recommended Phase 2 dose (RP2D) is established

Presented animal data at American Society for Hematology showing Annamycin’s synergistic activity against AML when used in combination with the Ara-C; based on this data we plan a potential Phase 1/2 trial with Annamycin in combination with Ara-C on AML in 2021
Immune/Transcription Modulators – WP1066 Portfolio

Reported positive interim results in Emory University pediatric brain tumor Phase 1 clinical trial; DIPG patient showed an apparent response in first cohort

Advanced WP1066 for GBM in adults to fourth and final cohort in dose escalation trial at MD Anderson; notified physician sponsoring trial is leaving MD Anderson; pursuing IND transfer and continuation of research

Received "Rare Pediatric Disease" designation from FDA for WP1066; entitles Moleculin to receive a transferrable Priority Review Voucher upon New Drug Approval for any one of three different brain tumor indications
Infectious Disease and Metabolism/Glycosylation Inhibitors- WP1122, WP1096 and WP1097 Portfolio

Multiple positive pre-clinical in-vitro studies on WP122 in its potential ability to address COVID-19

Positive in vitro results demonstrating the antiviral activity of WP1096 and WP1097 in a range of infectious diseases including: SARS-CoV-2, HIV, Zika and Dengue Fever

Working to initiate a Phase 1a/1b clinical trial in COVID-19 or a physician-sponsored clinical trial for a cancer indication, or both in 2021
Anticipated 2021 Milestones

Potential for 8 clinical trials in 2021, including 3 to be conducted by Moleculin and 5 primarily externally funded and conducted trials; External funding will be relied upon to the extent it is available
Management Discussion

"We are extremely pleased by the progress we made over the past year despite headwinds from the global COVID-19 pandemic. 2020 proved to be a pivotal year for the Company as we progressed our clinical trials and expanded our product pipeline. Although we are still in the early months of 2021, we are excited to see this momentum build, as we have raised approximately $81 million in the first quarter, which will enable us to further pursue our pipeline with expanded pre-clinical and clinical activities, through at least 2023," commented Walter Klemp, Chairman and CEO of Moleculin.

"We continue to see tremendous progress and promise across our three primary drug candidates, which have accounted for five Phase 1 clinical trials either completed or under way to date. Our lead candidate Annamycin, our "Next Generation Anthracycline" designed to avoid multidrug resistance mechanisms, received an independent assessment last year, which confirmed the absence of cardiotoxicity in patients treated in both our US and European open label and single arm Phase 1/2 clinical trials for acute myeloid leukemia. We were pleased to conclude our US Phase 1/2 clinical trial of Annamycin in AML, and following discussions with the FDA, will focus on establishing a recommended Phase 2 Dose and generating requested safety and efficacy data within our European trial in Poland. In our European trial, we are currently treating patients in the 5th cohort at 240 mg/m2. Dose limiting toxicities relating to liver function have now been noted at this level sufficient to establish an upper limit of dosing. We are planning to amend the protocol for this trial to allow exploration of an intermediate dose level between the 210 mg/m2 dose in the fourth cohort and the current 240 mg/m2 dose level, in order to establish the maximum tolerated dosage (MTD) and Recommended Phase 2 dose (RP2D), which may be the same. As soon as the RP2D is established, we intend to begin a Phase 2 expansion phase to assess the efficacy of Annamycin as a single agent. In addition, as a result of our preclinical research showing potential synergistic effect from combining Annamycin with Ara-C (a drug commonly used as a single agent and in combination chemotherapy for AML), we also intend to begin the Phase 1 portion of an AML trial using Annamycin in combination with Ara-C.

While we are pleased by our continued development of Annamycin in AML, we are also excited by the encouraging results observed in Annamycin’s ability to treat lung metastases. Sponsored research has demonstrated that Annamycin is capable of accumulating in the lungs in animal models at concentration levels up to 34-fold higher than doxorubicin, the current standard of care chemotherapy for a range of lung metastases. This research has also shown that Annamycin has activity in several different lung metastases, including sarcoma, colorectal cancer and triple negative breast cancer. Most recently, we announced that Annamycin demonstrated a potentially significant therapeutic benefit against metastatic osteosarcoma in a preclinical animal study. In this preclinical study, computerized tomography scans showed that animals treated with Annamycin exhibited significant suppression of tumor growth. Further, not a single death was observed in the treated animals, whereas significant tumor burden contributed to the rapid death of 90% of untreated animals. As of day 130 in the trial, the survival rate for animals treated with Annamycin was 100%, compared with only 10% for untreated animals. We have received both Investigational New Drug ("IND") status, and Orphan Drug Designation ("ODD") for Annamycin, allowing us to begin a Phase 1b/2 clinical trial in the US for patients with soft tissue sarcoma (STS) that has metastasized to the lungs after first-line therapy for their disease. To manage the upcoming Phase 1/2 Study in the US, we selected Catalyst Clinical Research as our contract research organization. Our efforts in progressing Annamycin in lung metastasis have also paved the way for a second European trial in 2021, as our license partner recently received a $1.5 million grant from Agencja Badań Medycznych in Poland to fund a Phase 1b/2 clinical trial of Annamycin for the treatment of soft tissue sarcoma lung metastases in Europe.

We also continued to drive the clinical development of WP1066, the lead molecule in Moleculin’s portfolio of immune stimulators and modulators of transcription. WP1066 is currently in two US physician-sponsored Phase 1/2 clinical trials, one at MD Anderson for the treatment of glioblastoma ("GBM") in adults and the second at Emory University for the treatment of pediatric brain tumors. In our Phase 1 clinical trial of WP1066 for the treatment of brain tumors in children being at conducted at the Aflac Cancer & Blood Disorders Center at Children’s Healthcare of Atlanta, the first cohort of patients was treated with no adverse events related to treatment and the trial has progressed full enrollment of the second cohort at a dose level of 6mg/kg. Notably, within the first cohort, one patient with diffuse intrinsic pontine glioma ("DIPG") showed an apparent response to the treatment with both clinical improvement and radiologic reduction of tumor size; we are particularly encouraged by this apparent response as approximately 200 clinical trials have been conducted in DIPG, and no drug to date has been able to show significant activity in this disease.

In our trial at MD Anderson, WP1066 is in the fourth and final cohort in the dose escalation phase. We were notified during the first quarter of 2021 that the physician sponsoring this trial is leaving MD Anderson. Although we cannot be assured that this trial will continue at MD Anderson after her departure, we have requested that MD Anderson have the IND for this trial transferred into our name to help ensure the potential continuation of this important research. While we are making arrangements to pursue this research in additional physician-sponsored trials, we expect that continued research on WP1066 in adult GBM will be temporarily delayed in 2021.

In addition to WP1066, we see meaningful opportunity in WP1220, which is an analog of WP1066, in treating cutaneous T-cell lymphoma ("CTCL"). The US market for CTCL had estimated sales of $40 million in 2020 and consisted of technologies that are as much as 40 years old. The data from our WP1220 Proof of Concept Trial for the treatment of CTCL, while limited in patient size, was promising; WP1220 demonstrated an objective response rate of 45%, with no adverse events and 55% stable disease, resulting in 100% clinical benefit. Given the tremendous market opportunity and these strong early indications of efficacy, we plan to seek a collaborative partner to support a Phase 2 clinical study of WP1220 in CTCL in 2021.

While we continue to drive the further development of our drugs that are showing meaningful activity in cancer indications, we believe our WP1122 portfolio holds tremendous opportunity for creating long-term shareholder value in the area of infectious disease. In 2020, WP1122 demonstrated its unique mechanism of action and in-vitro activity in numerous preclinical studies and independent research. We believe the preclinical work conducted and under way for WP1122 will support an IND application or its equivalent in other countries for either cancer-related or virus-related clinical trials (or both) during the first half of 2021. Although our initial preclinical focus for the WP1122 program was to help provide a treatment for the growing COVID-19 pandemic, we discovered that two other molecules within our portfolio of antimetabolites displayed significant in vitro antiviral activity against SARS-CoV-2 and other hard to treat viruses. Independent laboratory testing of our drug candidates, WP1096 and WP1097, not only showed significant antiviral activity against SARS-CoV-2, but also showed greater potential against HIV, Zika, and Dengue Fever. We caution that the above data is preclinical and there is no assurance that we will see similar results in our planned clinical trials."

Mr. Klemp concluded, "Our strategy since founding Moleculin has been to deliver long term shareholder value through our ‘multiple shots on goal strategy’. Following our recent capital raise in the first quarter of 2021, we are now optimally positioned to deliver on this strategy, with cash runway through at least 2023, and the potential to see 8 clinical trials this year on our drug candidates."

Financial Results for the Year Ended December 31, 2020

Research and development ("R&D") expense was $12.8 million and $11.0 million for the years ended December 31, 2020 and 2019, respectively. The increase in R&D of $1.8 million was primarily driven by increased clinical trial activity (3 drugs in 4 clinical trials in 2019, versus 3 drugs in 5 clinical trials in 2020), increased costs related to sponsored research agreements, costs related to manufacturing of additional drug product, and two additional employees in R&D headcount.

General and administrative ("G&A") expense was $6.8 million and $6.3 million for the years ended December 31, 2020 and 2019, respectively. The increase in G&A of $0.5 million was mainly attributable to increased payroll related costs for an additional finance staff, increased stock-based compensation expense, and increased costs for officer’s liability insurance being partially offset by reduced travel expenses due to the COVID-19 pandemic.

Net loss for the year ended December 31, 2020 was $17.4 million, which included non-cash gains of $2.3 million on warrants in 2020 as compared to $4.1 million in the prior year and approximately $1.7 million of stock-based compensation expense in 2020 as compared to $1.5 million in 2019.

Liquidity and Capital Resources

We believe that our cash resources as of December 31, 2020, along with the additional funding received subsequent to year-end, will be sufficient to meet our projected operating requirements, based on our current use of cash, through at least the year 2023. Such projections are subject to changes in our internally funded preclinical and clinical activities, including unplanned preclinical and clinical activity.