On March 10, 2021 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, reported the planned presentation of two posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting I, taking place April 10-15, 2021 (Press release, Alpine Immune Sciences, MAR 10, 2021, View Source [SID1234576394]). Dr. Mark Voskoboynik of Nucleus Network and The Alfred Hospital in Melbourne, Australia, will be presenting a poster in the Phase 1 Clinical Trials in Progress session on NEON-1, a Phase I study of ALPN-202 in advanced malignancies. Separately, Alpine researchers will present a preclinical poster describing the application of Alpine’s directed evolution platform to the development of fusion proteins capable of tumor antigen-dependent CD28 costimulation, as a distinctive immuno-oncology approach.

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Details of the presentations are as follows:

Presentation Title: NEON-1: A first-in-human phase I open-label study of ALPN-202, a conditional CD28 costimulator and dual checkpoint inhibitor, in advanced malignancies

Session Category: Phase I Clinical Trials in Progress
Session Title: Phase I Clinical Trials in Progress
Date Poster Available: Saturday, April 10th
Session Type: E-Poster Session
Poster Number: CT213
Presentation Title: Engineered variant domain fusion proteins provide checkpoint inhibition and tumor antigen dependent CD28 costimulation resulting in potent anti-tumor immunity

Session Category: Immunology
Session Title: Immunomodulatory Agents and Interventions
Date Poster Available: Saturday, April 10th
Session Type: E-Poster Session
Poster Number: 1740
Titles and/or full abstracts are available on the AACR (Free AACR Whitepaper) Virtual Annual Meeting website. Posters for both presentations will be available on the Scientific Publications page of Alpine’s website on April 10th.

About ALPN-202

ALPN-202 is a first-in-class, conditional CD28 costimulator and dual checkpoint inhibitor designed to improve upon the efficacy of combined checkpoint inhibition while limiting significant toxicities. Preclinical studies of ALPN-202 demonstrated superior efficacy in tumor models compared to checkpoint inhibition alone. NEON-1 (NCT04186637), a Phase 1 study of ALPN-202 in patients with advanced malignancies, is currently enrolling.

On March 10, 2021 GlycoMimetics, Inc. (Nasdaq: GLYC) reported that an abstract presenting the interim analysis of a Phase 1b proof-of-concept study of GMI-1359, the Company’s dual antagonist of E-selectin and CXCR4, has been accepted for presentation at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) 2021 Annual Meeting, to be held virtually on April 10-15 and May 17-21 (Press release, GlycoMimetics, MAR 10, 2021, View Source [SID1234576393]). Preclinical studies indicate that targeting both E-selectin and CXCR4, a chemokine receptor, with a single compound could improve efficacy in the treatment of cancers that affect the bone and bone marrow, such as breast and prostate cancer. A second abstract also accepted for presentation highlights, for the first time, preclinical data in pancreatic cancer for the Company’s novel dual antagonist of galectin-3 and E-selectin, GMI-1757. The latter is featured as a late-breaking abstract on the compound’s impact on fibrosis, mononuclear cell infiltration, and anti-PD-L1 therapeutic activity in a pancreatic adenocarcinoma model.

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GlycoMimetics Chief Executive Officer Rachel King said, "We look forward to sharing results from two programs in our advancing portfolio at the upcoming AACR (Free AACR Whitepaper) meeting, including the interim analysis of Phase 1b clinical data supporting further advancement of the GMI-1359 program. We are extremely proud to be collaborating with the Duke Cancer Institute on this important work, which we believe holds great promise in delivering a novel approach to treating cancers with bone involvement."

Details on GlycoMimetics e-presentations at the AACR (Free AACR Whitepaper) Meeting are as follows:

Title: "Development of GMI-1359, a Novel Agent Targeting Tumor-microenvironment Cross-talk in Bone Metastatic Breast Cancer"
Presenter: Dorothy Sipkins, M.D., Ph.D., Duke Cancer Institute
Session: e-Presentation
Date and Time: Saturday, April 10, 2021 (available online through Monday, June 21)

Title: A novel glycomimetic compound (GMI-1757) with dual functional antagonism to E-selectin and galectin-3 attenuates fibrosis, facilitates mononuclear cell infiltration and optimizes anti-PD-L1 therapeutic activity in a pancreatic adenocarcinoma model
Presenter: William E. Fogler, M.D., GlycoMimetics
Session: e-Presentation
Date and Time: Saturday, April 10, 2021 (available online through Monday, June 21)

About GMI-1757

An innovative dual antagonist of E-selectin and galectin-3, GMI-1757 was described in a poster presented at the 2018 annual meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper). The poster showcased the anti-thrombotic activity of the dual antagonist and suggested the compound may be able to play a role in the treatment of a variety of cancers and fibrotic conditions.

About GMI-1359

GMI-1359 is designed to simultaneously inhibit both E-selectin and CXCR4. E-selectin and CXCR4 are both adhesion molecules involved in tumor trafficking and metastatic spread. Preclinical studies indicate that targeting both E-selectin and CXCR4 with a single compound could improve efficacy in the treatment of cancers that involve the bone marrow, such as AML and multiple myeloma, or in solid tumors that metastasize to the bone, such as prostate cancer and breast cancer, as well as in osteosarcoma, a rare pediatric tumor affecting about 900 adolescents a year in the United States. GMI-1359 has completed a Phase 1 clinical trial in healthy volunteers. A Phase 1b clinical study is underway in breast cancer patients and is designed to enable investigators to identify an effective dose of the drug candidate and to generate initial biomarker data around the drug’s activity. GMI-1359 has received Orphan Drug designation and Rare Pediatric Disease designation from the FDA for the treatment of osteosarcoma.

On March 10, 2021 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, reported that the first patient has been dosed in a Phase 1 clinical trial of BGB-15025, its investigational hematopoietic progenitor kinase 1 (HPK1) inhibitor (Press release, BeiGene, MAR 10, 2021, View Source [SID1234576392]). BGB-15025 is designed to be a potent and highly selective small molecule oral inhibitor of HPK1, a kinase downstream of the T cell receptor (TCR) signaling pathway that is believed to play a key role in T cell activation.

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"We are incredibly proud of BeiGene’s research organization, which now has over 450 people, and its ability to discover not only potentially best-in-class cancer treatments but also investigational agents like BGB-15025, which we believe to be among the first HPK1 inhibitors to enter the clinic and represent a novel immuno-oncology approach targeting T cell activation to fight cancer growth," commented Lai Wang, Ph.D., Senior Vice President, Head of Global Research, Clinical Operations & Biometrics and APAC Clinical Development at BeiGene. "We believe that the unique nature of BGB-15025 and the HPK1 pathway provides us with a compelling scientific rationale for investigating it as a monotherapy and in combination with our anti-PD-1 antibody, tislelizumab. We are excited to advance its clinical development globally."

This first-in-human Phase 1 trial (NCT04649385) will assess the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of BGB-15025 alone and in combination with tislelizumab in patients with advanced solid tumors. This trial will be conducted in multiple countries globally.

About BGB-15025

BGB-15025 is an investigational hematopoietic progenitor kinase 1 (HPK1) inhibitor discovered and being developed by BeiGene. HPK1 is a key negative feedback regulator of T-cell receptor signaling, which is believed to play a key role in antitumor immune response. In preclinical studies, the inhibition of HPK1 enhanced T-cell activation, which is expected to enhance the anti-tumor activity of anti-PD-1 inhibitors such as BeiGene’s tislelizumab.

About Tislelizumab

Tislelizumab (BGB-A317) is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first approved medicine from BeiGene’s immuno-oncology biologics program and is being developed globally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

Tislelizumab is approved in China for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy. Tislelizumab has also received conditional approval in China for the treatment of patients with classical Hodgkin’s lymphoma (cHL) who received at least two prior therapies, and for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Full approval for these indications is contingent upon results from ongoing randomized, controlled confirmatory clinical trials.

In addition, three supplemental Biologics License Applications for tislelizumab have been accepted and are under review in China for first-line treatment of patients with advanced non-squamous NSCLC in combination with

chemotherapy, for the second- or third-line treatment of patients with locally advanced or metastatic NSCLC who progressed on prior platinum-based chemotherapy, and for previously treated unresectable hepatocellular carcinoma.

Currently, 15 potentially registration-enabling clinical trials are being conducted in China and globally, including 12 Phase 3 trials and two pivotal Phase 2 trials.

In January 2021, BeiGene and Novartis entered into a collaboration and license agreement to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.
Tislelizumab is not approved for use outside of China.

On March 10, 2021 Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, reported financial results for the fourth quarter and full year ended December 31, 2020 and provided a corporate update (Press release, Harpoon Therapeutics, MAR 10, 2021, View Source [SID1234576391]).

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"This past year was transformative for Harpoon, culminating in the pipeline update we provided in December last year that detailed the strong progress we have made across all our clinical programs," said Jerry McMahon, Ph.D., President and Chief Executive Officer of Harpoon Therapeutics. "We are encouraged by what we have observed in our dose escalation trials including a confirmed partial response for HPN424, our most advanced program. With our successful follow-on equity offering in January 2021, we are in a strong financial position and we expect to generate and present data on all four of our clinical TriTAC programs throughout the course of 2021, including advancement of the portfolio into multiple dose expansion studies."

Fourth Quarter 2020 Business Highlights and Other Recent Developments

In January 2021, Harpoon announced that the the first patient had been dosed in a Phase 1/2 clinical trial for HPN328, the company’s fourth TriTAC in clinical development. HPN328 targets delta-like ligand 3 (DLL3) for the treatment of small cell lung cancer (SCLC) and other DLL3-expressing tumors.

In January 2021, Harpoon completed a successful follow-on public offering of its common stock resulting in net proceeds of approximately $108.1 million, after deducting underwriting discounts and commissions and other offering costs.

In December, Harpoon provided a corporate pipeline update and reported a confirmed partial response based on RECIST v1.1 criteria for its most advanced program, HPN424 for the treatment of metastatic castration-resistant prostate cancer (mCRPC). As of December 1, 2020, the the highest fixed dose cohort at 160ng/kg, demonstrated that one patient has achieved a confirmed partial response in the ongoing study. In addition, 3 of the 7 patients enrolled in this cohort, had serum PSA reductions, including one with a reduction of 50% (PSA50). Presentation of Phase 1 data and initiation of an expansion cohort is planned for the first half of 2021 with interim data from this expansion cohort anticipated by the end of 2021.

In December, Harpoon also provided an update on dose escalation trials for HPN536 and HPN217. For the HPN536 Phase 1/2a clinical trial for the treatment of ovarian and pancreatic cancers and other mesothelin-expressing solid tumors, dosing has occurred across 9 fixed-dose cohorts of 6 to 280ng/kg and 1 step dose cohort up to 600ng/kg. Initiation of an expansion cohort is anticipated in the second half of 2021, with a presentation of Phase 1 clinical data expected by year-end 2021. Additionally, the Phase 1 dose escalation for HPN217 (a BCMA-targeting TriTAC) is progressing well, and as of December 1, 2020, 6 relapsed/refractory multiple myeloma patients had been treated in fixed dose cohorts ranging from 5 to 810µg, reflecting a more than 100-fold increase in dose in 8 months. A presentation of interim data is anticipated in 2021, and initiation of a dose expansion cohort is expected in the second half of 2021.

In January 2021, Harpoon was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for HPN217 for the treatment of multiple myeloma. HPN217 targets B-cell maturation antigen (BCMA).

Harpoon nominated its first ProTriTAC product candidate, HPN601, which is currently in preclinical development and targets epithelial cell adhesion molecule (EpCAM), and is applicable to a wide array of solid tumors. ProTriTACs have the potential for additional tumor specificity and enhanced safety profiles due to limited interaction with their molecular targets in healthy tissue, which enables targeting tumor-associated antigens that may be more broadly expressed. Harpoon presented encouraging preclinical data for HPN601 at the 35th Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting on November 12, 2020.
Fourth Quarter and Full Year 2020 Financial Results

Harpoon ended the fourth quarter of 2020 with $150.0 million in cash, cash equivalents, and marketable securities compared to $155.1 million as of December 31, 2019. The cash balance at the end of the year does not include the follow-on financing that closed on January 11, 2021 resulting in net proceeds of approximately $108.1 million.

Revenue for the quarter ended December 31, 2020 was $7.5 million compared to $2.2 million for the quarter ended December 31, 2020. Revenue for the year ended December 31, 2020 was $17.4 million, compared to $5.8 million for the prior year. During both the three month and full year periods, the increase in revenue was primarily due to revenue recognized from the development and option agreement with AbbVie, signed in November 2019.

Research and development (R&D) expense for the quarter ended December 31, 2020 was $15.1 million compared to $12.7 million for the quarter ended December 31, 2019. R&D expense for the year ended December 31, 2020 was $52.6 million, compared to $41.6 million for the prior year. The increase for both periods primarily arose from higher clinical development and personnel-related expense, which included conducting preclinical studies and the continuation and preparation of the clinical trials for HPN424, HPN536, HPN217 and HPN328. These higher expenses were offset by a decrease in manufacturing costs due to a scale up of manufacturing activities in 2019 compared to 2020 to support our four TriTAC product candidates in various stages of development.

General and administrative (G&A) expense for the quarter ended December 31, 2020 was $3.9 million compared to $4.3 million for the quarter ended December 31, 2019. General and administrative expenses for the year ended December 31, 2020 were $16.2 million, compared to $22.4 million for the prior year. The decrease was primarily attributable to lower legal fees associated with the Maverick litigation incurred in 2020, partially offset by an increase in personnel expenses related to an increase in headcount and other professional services to support our operations as a public company.

Net loss for the quarter ended December 31, 2020 was $11.4 million compared to $14.3 million for the quarter ended December 31, 2019. Net loss for the year ended December 31, 2020 was $49.9 million, compared to $55.6 million for the prior year.
Anticipated 2021 Milestones

HPN424 – in the first half of 2021, present interim data from the dose escalation phase of our Phase 1/2a trial and initiate the dose expansion cohort
HPN536 – in the second half of 2021, initiate the dose expansion cohort of our Phase 1/2a trial and, by year end 2021, present interim Phase 1 data from the dose escalation phase of the trial
HPN217 – in the second half of 2021, initiate the dose expansion cohort of our Phase 1/2 trial, and, in 2021, present interim data from the dose escalation phase of the trial
HPN328 – in the second half of 2021, present interim data from the dose escalation phase of our Phase 1/2 trial
2021 Financial Guidance

For 2021, management estimates cash used in operating activities of approximately $85 to $95 million.

COVID-19 Business Update

In response to the ongoing COVID-19 pandemic, Harpoon has established testing and other protocols for personnel access to its headquarter offices and laboratory although the majority of the company’s employees continue to telecommute. Harpoon is currently continuing its clinical trials, and has not yet experienced any material delays or impacts as a result of the COVID-19 pandemic. In addition, Harpoon’s third-party contract manufacturers continue to operate at or near normal levels. Harpoon continues to assess the potential impact of the COVID-19 pandemic on its business and operations, including its programs, expected timelines, expenses, manufacturing activities and preclinical and clinical trials. The full extent to which the COVID-19 pandemic may have a negative impact on Harpoon’s business, assets, results of operations and financial condition will depend on future developments that are highly uncertain and cannot be accurately predicted.

Conference Call and Webcast

Harpoon’s management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT today, March 10, 2021, to discuss the financial results for the fourth quarter and full year 2020 and provide a corporate update. The live call may be accessed by dialing 866-951-6894 for domestic callers and 409-216-0624 for international callers and entering the conference code: 4785099. A live webcast and archive of the call will be available online from the investor relations section of the company website at View Source

On March 10, 2021 Protagonist Therapeutics, Inc. ("Protagonist" or the "Company") (Nasdaq: PTGX) reported financial results and provided a corporate update for the fourth quarter and full year ended December 31, 2020 (Press release, Protagonist, MAR 10, 2021, View Source [SID1234576390]).

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"The year 2020 marked a significant period of growth for Protagonist as we focused on expanding the scope of our pipeline and advancing different development molecules in multiple clinical programs and indications," commented Dinesh V. Patel, Ph.D., Protagonist President and Chief Executive Officer. "In December, we released compelling interim data from our ongoing Phase 2 trial with our most advanced candidate, rusfertide, which has received orphan drug designation and Fast Track designation for the treatment of polycythemia vera, a rare disease that affects about 100,000 treated patients in the U.S. alone. In the first half of 2021, we expect to complete our planned regulatory interactions and finalize the registrational clinical development plan, which represents an important turning point for the Company as rusfertide has the potential to become a new therapeutic treatment option for polycythemia vera patients. Continuing with the momentum of building our rusfertide portfolio, we expect to announce initial results of the hereditary hemochromatosis proof-of-concept trial in the second half of 2021 and select an additional indication for this candidate in 2021."

Dr. Patel added, "This past year, we continued to make progress with our ongoing 150-patient, Phase 2 IDEAL trial in ulcerative colitis with the gut-restricted alpha-4-beta-7 integrin blocker PN-943 and expect to complete this study in 2022. During the year, we also added two new clinical development stage assets to the ongoing oral IL-23 receptor antagonist program with our partner, Janssen. With a strong cash position through mid-2024, we look forward to focusing our capital to continue building value across our portfolio."

PRODUCT DEVELOPMENT AND CORPORATE UPDATE

Disorders of Red Blood Cells and Iron Regulation

Rusfertide (PTG-300)
Investigational, injectable, hepcidin mimetic discovered through our peptide technology platform. Hepcidin regulates iron homeostasis and controls the absorption, storage, and distribution of iron in the body. Rusfertide is currently being evaluated for disorders associated with iron overload and excessive erythrocytosis (red blood cell production).

At the American Society of Hematology (ASH) (Free ASH Whitepaper) conference this past December, Protagonist presented updated data for 18 patients with polycythemia vera ("PV") treated with rusfertide in the ongoing Phase 2 study, which demonstrated dramatic decreases in the need for therapeutic phlebotomy by maintaining control over blood hematocrit levels.
By mid-2021, Protagonist expects to complete enrollment of 50 patients for the ongoing Phase 2 study of rusfertide in low-risk and high-risk PV patients requiring frequent phlebotomy treatment.
The Company is consulting with regulatory authorities on the registrational clinical development plan for rusfertide in PV in the first half of 2021.
In December 2020, Protagonist released findings from a large-scale independent analysis of real-world data, which demonstrated that hematocrit levels are not adequately managed for a majority of PV patients on currently available treatment options, across broad categories, including both high-risk and low-risk patient groups.
In December 2020, the U.S. Food and Drug Administration ("FDA") granted Fast Track designation to rusfertide for PV. In October 2020, the European Medicines Agency ("EMA") granted orphan drug designation to this candidate in the same indication. The FDA previously awarded rusfertide orphan drug designation in the U.S.
Protagonist is expecting to announce preliminary results in the second half of 2021 from the ongoing Phase 2 open-label proof-of-concept study of rusfertide in patients with hereditary hemochromatosis ("HH"); a disease affecting over a million people in the U.S. and with no approved therapies.
Beyond PV and HH, the Company expects to select a third indication for rusfertide in 2021.
During the first quarter of 2021, Protagonist initiated a new open-label Phase 2 study for rusfertide in PV patients with routinely elevated hematocrit levels (>48%).
Inflammatory Bowel Diseases

PN-943
Investigational, orally delivered, gut-restricted alpha-4-beta-7 specific integrin antagonist for inflammatory bowel diseases.

The 150-patient Phase 2 study (the "IDEAL" study) evaluating the safety, tolerability and efficacy of PN-943 in patients with moderate to severe ulcerative colitis is underway and completion is expected in 2022.
Oral IL-23 Receptor Antagonists

PTG-200; PN-235; PN-232
Investigational, orally delivered, IL-23 receptor antagonists.

In October 2020, Protagonist and Janssen announced two new, second-generation oral candidates, PN-235 and PN-232, to be developed as part of our joint oral IL-23 pathway blocker portfolio strategy. A Phase 1 study of PN-235 and a Phase 1 study of PN-232 are expected to be completed in the second half of 2021.
The Phase 2A proof-of-concept study (the "PRISM" study) with the first-generation candidate PTG-200 for patients with moderate to severe Crohn’s disease is continuing to enroll in 2021.
Financial Update

During the fourth quarter of 2020, the Company raised approximately $115.0 million through an underwritten public offering of common stock where 5,476,189 shares were sold at a price to the public of $21.00 per share.
The Company sold an additional 918,000 shares through its At-the-Market ("ATM") program during October 2020, raising $18.9 million at an average net price of $20.56 per share.
Throughout 2020, Protagonist raised $255 million in capital, net expenses, through two public offerings and its ATM program.
Financial Results

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of December 31, 2020 were $307.8 million. The Company expects current cash, cash equivalents and marketable securities and access to its debt facility to be sufficient to fund its planned operating and capital expenditures through first half of 2024.
License and Collaboration Revenue: License and collaboration revenue was $5.7 million for the fourth quarter of 2020 compared to $2.7 million for the same period of 2019. The increase was primarily due to the additional services provided to Janssen under the collaboration agreement during 2020 related to PN-232 and PN-235. License and collaboration revenue for the full year 2020 was $28.6 million compared to $0.2 million for 2019. The increase that occurred in Protagonist’s year over year revenue under the Janssen collaboration included: completion of additional services during 2020, primarily related to PN-232 and PN-235; an update to the forecast for remaining services to be completed under the collaboration, accelerating our overall percentage completion under the accounting performance obligation; and the previously reported 2019 one-time cumulative adjustment related to the application of revenue recognition principles following the May 2019 amendment of the Janssen collaboration agreement, which previously reduced revenue by $9.4 million during 2019.
Research and Development ("R&D") Expenses: R&D expenses for the fourth quarter and full year 2020 were $19.5 million and $74.5 million respectively, as compared to $15.9 million and $65.0 million, respectively, for the same periods of 2019. The increases were primarily due to advancing our clinical trials with our pipeline assets rusfertide and PN-943, as well as all three of our IL-23 receptor antagonist assets under the Janssen collaboration (PTG-200, PN-235 and PN-232).
General and Administrative ("G&A") Expenses: G&A expenses for the fourth quarter and full year 2020 were $5.0 million and $18.6 million, respectively, as compared to $4.1 million and $15.7 million for the same periods of 2019. The increases were primarily related to professional fees, insurance costs and employee compensation related expenses supporting the growth in our operations.
Net Loss: The fourth quarter net loss was $18.9 million, or a net loss of $0.48 per share, and the full year 2020 net loss was $66.2 million, or a net loss of $1.92 per share, compared to the fourth quarter of 2019 net loss of $17.5 million, or a net loss of $0.63 per share, and the full year 2019 net loss was $77.2 million, or a net loss of $2.98 per share.
Conference Call and Webcast Information

To access the live call, dial 1-844-515-9178 (U.S./Canada) or 1-614-999-9313 (International) and refer to conference ID #: 7756175. A live webcast of the call will also be accessible on the Investors section of the Company’s website at www.protagonist-inc.com. The replay will be available on the company’s website approximately two hours after the call and will remain available for 60 days.