On February 25, 2021 Acorda Therapeutics, Inc. (NASDAQ: ACOR) reported that it will host a conference call and webcast in conjunction with its fourth quarter and year end 2020 update and financial results on Thursday, March 4 at 4:30 p.m. ET (Press release, Acorda Therapeutics, FEB 25, 2021, View Source [SID1234575671]).

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To participate in the Webcast/Conference Call, please note there is a new pre-registration process.

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Once you have registered, you will receive a confirmation email with Webcast/Conference Call details. For the Webcast you will receive an email 2 hours prior to the start of the call with the link to join. The presentation will be available on the Investors section of www.acorda.com.

A replay of the call will be available from 7:30 p.m. ET on March 4, 2021 until 11:59 p.m. ET on April 3, 2021. To access the replay, please dial (800) 585-8367 (domestic) or (416) 621-4642 (international); reference code 9854802. The archived webcast will be available in the Investor Relations section of the Acorda website at www.acorda.com.

On February 25, 2021 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported fourth quarter and full-year financial results for the period ended December 31, 2020 and provided an update on recent company developments (Press release, SpringWorks Therapeutics, FEB 25, 2021, View Source [SID1234575670]).

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"2020 was a year characterized by strong performance for SpringWorks as we advanced our diversified targeted oncology portfolio, which currently spans 10 development programs across our three core focus areas: late-stage rare oncology, BCMA combinations in multiple myeloma and biomarker-defined metastatic solid tumors," said Saqib Islam, Chief Executive Officer of SpringWorks. "Our clinical execution has set the stage for multiple important data readouts in 2021, including the interim ReNeu data announced this morning and topline data from our Phase 3 DeFi trial later this year, and our business development efforts have allowed us to pursue additional combination therapy programs, continuing to grow our portfolio of opportunities across a broad range of potentially high-value and high-unmet need oncology patient settings. We look forward to reporting on our progress throughout 2021."

Recent Business Highlights and Upcoming Milestones

Late-Stage Rare Oncology

In February 2021, SpringWorks reported interim data from the adult stratum of the ongoing potentially registrational Phase 2b ReNeu trial evaluating mirdametinib in pediatric and adult patients with NF1-associated plexiform neurofibromas. Of the first 20 adult patients enrolled, 50% had achieved an objective response, the primary endpoint of the study, as assessed by blinded independent central review, and 16 of these 20 patients (80%) remained on study as of the January 22, 2021 data cutoff. In addition, mirdametinib was generally well tolerated, with the majority of treatment-related adverse events (TRAE) being Grade 1 or 2 and only one Grade 3 TRAE reported; there have been no Grade 4 or 5 AEs reported. SpringWorks reported that the ReNeu trial has reached approximately 70% of its final enrollment target of 100 patients and the Company expects to complete enrollment of the ReNeu trial in the second half of 2021.
SpringWorks expects to report topline data from the Phase 3 DeFi trial in the second half of 2021.
Recruitment is ongoing in a Phase 2 study sponsored by the Children’s Oncology Group evaluating nirogacestat in pediatric patients with desmoid tumors.
B-cell Maturation Antigen (BCMA) Combinations in Multiple Myeloma

Enrollment is ongoing in a Phase 1b trial sponsored by GSK evaluating nirogacestat in combination with BLENREP (belantamab mafodotin-blmf), GSK’s anti-B-cell maturation antigen (BCMA) antibody-drug conjugate, in adult patients with relapsed or refractory multiple myeloma. Initial clinical data from this study are expected in 2021.
Two collaborator-sponsored Phase 1 studies were initiated evaluating nirogacestat in combination with BCMA therapies: nirogacestat + Allogene’s ALLO-715 and nirogacestat + Janssen’s teclistamab. SpringWorks also expects that two additional collaborator-sponsored trials will initiate in the first half of 2021, as previously disclosed: nirogacestat + Pfizer’s elranatamab (PF‐06863135) and nirogacestat + Precision’s PBCAR269A.
Biomarker-Defined Metastatic Solid Tumors

Enrollment is ongoing in a Phase 1b/2 trial evaluating mirdametinib with BeiGene’s RAF dimer inhibitor, lifirafenib, in adult patients with RAS/RAF mutant and other MAPK pathway aberrant solid tumors. BeiGene is sponsoring this trial and SpringWorks and BeiGene expect to report initial clinical data in 2021.
Enrollment is ongoing in a Phase 1 trial of BGB-3245 in adult patients with RAF mutant solid tumors. BGB-3245 is a selective RAF dimer inhibitor being developed by MapKure, LLC, a joint venture between SpringWorks and BeiGene. Initial clinical data from the MapKure-sponsored Phase 1 trial are expected in 2021.
In December 2020, SpringWorks entered into a research collaboration agreement with Dr. Tatu Pantsar and Dr. Antti Poso at the University of Eastern Finland to conduct novel computational biology research to characterize the effector protein dynamics of different RAS mutations. The objective of the collaboration is to understand the biological consequences of KRAS-effector protein interactions and downstream oncogenic signaling with the goal of guiding patient selection strategies and exploring novel targets for future targeted therapy development.
General Corporate

In February 2021, a Notice of Allowance was received from the United States Patent and Trademark Office for Patent Application No. 16/886,622 (the ‘622 application) with composition of matter claims covering several polymorphic forms of nirogacestat, including the polymorphic form that is currently in clinical development, which is also covered by U.S. Patent 10,590,087 (the ‘087 patent, issued in March 2020). Pursuant to an existing worldwide license agreement with Pfizer, SpringWorks has exclusive rights to the patent issuing from the ‘622 application. The patent granting from the ‘622 application, as well as the ‘087 patent, will both expire in August 2039.
In October 2020, SpringWorks completed a follow-on public offering that raised $269.5 million in net proceeds, which included the underwriters’ full exercise of their option to purchase additional shares of common stock.
In October 2020, SpringWorks and Jazz Pharmaceuticals entered into an asset purchase and exclusive license agreement under which Jazz acquired SpringWorks’ fatty acid amide hydrolase (FAAH) inhibitor program. Under the terms of the agreement, Jazz made an upfront payment of $35 million to SpringWorks, with potential future milestone payments of up to $375 million payable to SpringWorks based upon the achievement of certain clinical development, regulatory and commercial milestones. In addition, SpringWorks will receive incremental tiered royalties on future net sales of JZP-150 (formerly PF-04457845) in the mid- to high-single digit percentages.
Fourth Quarter and Full Year 2020 Financial Results

Revenue: Revenue of $35.0 million for the fourth quarter and year ended December 31, 2020 was attributable to the nonrefundable upfront payment from Jazz in October 2020, related to the asset purchase and exclusive license agreement between SpringWorks and Jazz.
Research and Development (R&D) Expenses: R&D expenses were $15.3 million and $51.9 million for the fourth quarter and year-to-date periods, respectively, compared to $12.2 million and $42.5 million for the comparable periods of 2019. The increases in R&D expenses in 2020 were primarily attributable to growth in employee costs associated with increases in the number of R&D personnel, including non-cash share-based compensation expenses, and increases in external costs related to drug manufacturing and clinical trial costs.
General and Administrative (G&A) Expenses: G&A expenses were $8.5 million and $29.5 million for the fourth quarter and year-to-date periods, respectively, compared to $5.2 million and $16.7 million for the comparable periods of 2019. The increases in G&A expenses in 2020 were primarily attributable to growth in employee costs associated with increases in the number of G&A personnel supporting the growth of the organization, including non-cash share-based compensation expenses, as well as increases in expenses related to the expansion of business activities.
Net Loss Attributable to Common Stockholders: SpringWorks reported net income of $11.3 million, or $0.24 per share, for the fourth quarter, and a net loss of $45.6 million, or $1.05 loss per share, for the year ended December 31, 2020. This compares to net losses of $16.2 million, or $0.39 loss per share, and $50.6 million, or $3.81 loss per share, for the comparable periods of 2019, respectively.
Cash Position: Cash, cash equivalents and marketable securities were $561.8 million as of December 31, 2020. This includes the net proceeds of $269.5 million from the Company’s follow-on public offering completed in October 2020, and the $35.0 million upfront payment from Jazz Pharmaceuticals in October 2020, related to the asset purchase and exclusive license agreement between SpringWorks and Jazz.
COVID-19 Update

To date, the COVID-19 pandemic has had a relatively modest impact on SpringWorks’ business operations, in particular on SpringWorks’ clinical trial programs, and SpringWorks is undertaking considerable efforts to mitigate the various challenges presented by this crisis. For further details and descriptions of the risks associated with the COVID-19 pandemic, please see the Risk Factors in SpringWorks’ periodic filings with the Securities and Exchange Commission and refer to the Forward-Looking Statements section in this press release.

On February 25, 2021 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a late-stage targeted oncology company,reported financial results for the fourth quarter and full year of 2020, which reflect the company’s progress across its clinical and discovery pipeline and strength as it expands its operational structure and capabilities in preparation for potential commercialization in the United States (Press release, Mirati, FEB 25, 2021, View Source [SID1234575669]).

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"Our commitment to patients with cancer has enabled us to advance our two clinical programs, adagrasib and sitravatinib, as well as our preclinical pipeline. These preclinical programs include MRTX1133, a potentially first-in-class KRAS G12D selective inhibitor and a first-in-class synthetic lethal PRMT5 inhibitor," said Charles M. Baum, M.D., Ph.D., president and chief executive officer, Mirati Therapeutics, Inc. "We have added significant new talent and capabilities across the organization which combined with our financial resources will allow us to accelerate and expand development across our pipeline."

Corporate Updates:

Announced a strategic research and development collaboration with MD Anderson Cancer Center to expand the clinical and preclinical evaluation of Mirati’s two investigational small molecule, potent and selective KRAS inhibitors, adagrasib, a G12C inhibitor, and MRTX1133, a G12D inhibitor, each as monotherapy and in combination with other agents. (View Release)
Entered into McKesson’s MYLUNG consortium ("Molecularly Informed Lung Cancer Treatment in a Community Cancer Network: A Pragmatic Consortium"), a collaborative research endeavor to deepen understanding of molecular testing barriers, improve care for patients with lung cancer, and expand the opportunity for patients to participate in clinical trials. (View Release)
Ended the fourth quarter with approximately $1.4 billion in cash, cash equivalents, and short-term investments.
Adagrasib:

Initiated KRYSTAL-7 (849-007), a Phase 2 clinical trial of adagrasib in combination with pembrolizumab (KEYTRUDA)1 in 1st line non-small cell lung cancer (NSCLC).
Initiated an additional Phase 2 cohort of the KRYSTAL-1 (849-001) in patients with KRAS G12C and the STK11 co-mutation in 1st line NSCLC.
Initiated KRYSTAL-12 (849-012), a Phase 3 clinical trial of monotherapy adagrasib versus docetaxel in 2nd line NSCLC.
Plan to initiate by Q2 2021 KRYSTAL-10 (849-010), a Phase 3 clinical trial of adagrasib in combination with cetuximab (ERBITUX)2 in 2nd line colorectal cancer.
1KEYTRUDA is a registered trademark of Merck
2ERBITUX is a registered trademark of Eli Lilly and Company in the U.S. and Merck KGaA outside the U.S.

Preclinical Updates:

Advanced a first-in-class PRMT5 inhibitor, leveraging a synthetic lethal strategy in MTAP-deleted cancers. This agent specifically inhibits the PRMT5 enzyme in the presence of methylthioadenosine (MTA), a nucleoside cofactor, which is uniquely elevated in cancers exhibiting the most commonly observed gene deletion event (MTAP/CDKN2A) across human cancers. Because PRMT5 is critical to the survival of normal human cells, the ability to specifically target the PRMT5/MTA complex in MTAP-deleted cancer cells while sparing normal human cells is expected to offer a wide therapeutic index compared with conventional first generation PRMT5 or MAT2A inhibitors.
Financial Results for the Fourth Quarter 2020

License and collaboration revenues for the three months ended December 31, 2020, were $1.7 million, and relate to the manufacturing supply services agreement with BeiGene. License and collaboration revenues for the twelve months ended December 31, 2020 were $13.4 million, of which $11.4 million related to a license agreement with ORIC Pharmaceuticals, Inc. and $2.0 million related to the manufacturing supply services agreement with BeiGene. License and collaboration revenues for the three and twelve months ended December 31, 2019 were $0.5 million and $3.3 million, respectively, and relate to the manufacturing supply services agreement with BeiGene.
Research and development expenses for the fourth quarter of 2020 were $82.7 million, compared to $62.9 million for the same period in 2019. Research and development expenses for the year ended December 31, 2020 were $299.3 million, compared to $182.9 million for the same period in 2019. The increase in research and development expenses is due to an increase in expense associated with the development of adagrasib, MRTX1133, and other preclinical and early discovery activities, as well as an increase in salaries and related expense, including an increase in share-based compensation expense. The Company recognized research and development-related share-based compensation expenses of $12.2 million during the fourth quarter of 2020, compared to $10.6 million for the same period in 2019, and $48.0 million during the year ended December 31, 2020, compared to $31.0 million for the same period in 2019.
General and administrative expenses for the fourth quarter of 2020 were $25.3 million, compared to $12.2 million for the same period in 2019. General and administrative expenses for the year ended December 31, 2020 were $83.4 million, compared to $42.6 million for the same period in 2019. The increase is due primarily to an increase in share-based compensation expense and an increase in employee-related expenses and professional service expense. The Company recognized general and administrative-related share-based compensation expenses of $9.6 million during the fourth quarter of 2020, compared to $6.1 million for the same period in 2019, and $37.8 million during the year ended December 31, 2020, compared to $24.5 million for the same period in 2019.
Net loss for the fourth quarter of 2020 was $101.1 million, or $2.08 per share basic and diluted, compared to net loss of $72.4 million, or $1.83 per share basic and diluted for the same period in 2019. Net loss for the year ended December 31, 2020 was $357.9 million, or $7.96 per share basic and diluted, compared to net loss of $213.3 million, or $5.69 per share basic and diluted for the same period in 2019.
Cash, cash equivalents, and short-term investments were $1.4 billion at December 31, 2020.

On February 25, 2021 Nektar Therapeutics (Nasdaq: NKTR) reported financial results for the fourth quarter and full year ended December 31, 2020 (Press release, Nektar Therapeutics, FEB 25, 2021, View Source [SID1234575668]).

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Cash and investments in marketable securities at December 31, 2020 were approximately $1.2 billion as compared to $1.6 billion at December 31, 2019.

"This past year, Nektar made significant progress advancing our clinical pipeline of novel cytokine therapeutics," said Howard W. Robin, President and CEO of Nektar. "Our broad registrational program evaluating bempegaldesleukin (BEMPEG) plus nivolumab is progressing well with five registrational studies underway in melanoma, renal cell carcinoma and bladder cancer. We also recently added a sixth study to the registrational program to evaluate BEMPEG in combination with pembrolizumab in head and neck cancer and are pleased to be collaborating with Merck on the study. For our PROPEL study, we look forward to reporting the first data for BEMPEG plus pembrolizumab in patients with metastatic non-small cell lung cancer in the second half of 2021."

"For our second cytokine program, NKTR-255, we were very encouraged by the early signs of clinical activity that we recently reported at the SITC (Free SITC Whitepaper) 2020 meeting, and are now advancing two Phase 1 clinical studies in combination with ADCC antibodies, one in hematological malignancies and one in solid tumors," continued Mr. Robin. "Finally, our partner Eli Lilly is conducting a broad Phase 2 program for NKTR-358, our T regulatory cell IL-2 agent, with Phase 2 studies in both lupus and ulcerative colitis and plans to initiate additional Phase 2 studies in immune-mediated diseases over the next 12-18 months."

Summary of Financial Results

Revenue in the fourth quarter of 2020 was $23.5 million as compared to $33.9 million in the fourth quarter of 2019. Revenue for the year ended December 31, 2020 was $152.9 million as compared to $114.6 million in 2019 and was higher primarily due to the recognition of $50.0 million in total milestones from Bristol-Myers Squibb related to the start of two new registrational trials of bempegaldesleukin plus Opdivo (nivolumab) in adjuvant melanoma and muscle-invasive bladder cancer.

Total operating costs and expenses in the fourth quarter of 2020 were $134.2 million as compared to $143.5 million in the fourth quarter of 2019. Total operating costs and expenses for 2020 were $578.0 million as compared to $554.7 million in 2019. Total operating costs and expenses for full year 2020 increased as compared to 2019 primarily as a result of $45.2 million in impairment charges in the first quarter of 2020 resulting from the discontinuation of the NKTR-181 program, partially offset by a decrease in R&D expense.

R&D expense in the fourth quarter of 2020 was $102.7 million as compared to $110.4 million for the fourth quarter of 2019. R&D expense for the year ended December 31, 2020 was $408.7 million as compared to $434.6 million in 2019. Excluding pre-commercial manufacturing costs for NKTR-181 incurred during 2019, research and development expense increased for the full year 2020 primarily due to the clinical development of bempegaldesleukin in five registrational trials.

G&A expense was $27.1 million in the fourth quarter of 2020 and $27.1 million in the fourth quarter of 2019. G&A expense for 2020 was $104.7 million as compared to $98.7 million in 2019.

Net loss for the fourth quarter of 2020 was $117.2 million or $0.65 basic and diluted loss per share as compared to a net loss of $112.2 million or $0.64 basic and diluted loss per share in the fourth quarter of 2019. Net loss for the year ended December 31, 2020 was $444.4 million or $2.49 basic and diluted loss per share as compared to net loss of $440.7 million or $2.52 basic and diluted loss per share in 2019.

2020 and Year-to-Date 2021 Business Highlights:

In February 2021, Nektar announced a clinical trial collaboration and supply agreement with Merck for a Phase 2/3 study of bempegaldesleukin, Nektar’s investigational IL-2 pathway agent, in combination with Merck’s KEYTRUDA (pembrolizumab) for first-line treatment of patients with metastatic or unresectable recurrent squamous cell carcinoma of the head and neck (SCCHN) whose tumors express PD-L1. The study is planned to start in the second half of 2021.
In February 2021, Nektar announced a financing and co-development collaboration with SFJ Pharmaceuticals for the development of bempegaldesleukin plus pembrolizumab in SCCHN. SFJ has agreed to fund up to $150 million to support the planned Phase 2/3 study and manage clinical trial operations for the study. In return, Nektar agrees to pay SFJ success-based annual milestone payments over a period of seven to eight years which are contingent upon receipt of certain U.S. regulatory approvals for specified indications for bempegaldesleukin, and will begin following completion of the SCCHN study, which is projected to be completed in 2024.
In December 2020, Nektar sold its royalties on future sales of ADYNOVATE and MOVANTIK to Healthcare Royalty Management, LLC in exchange for $150 million.
In December 2020, Nektar announced dosing of the first patient in its Phase 1/2 study of its IL-15 agonist, NKTR-255, in combination with cetuximab in patients with relapsed or refractory head and neck squamous cell carcinoma or colorectal cancer. The study may enroll up to 80 patients at approximately 15 investigator sites in the United States and European Union.
In December 2020, Nektar presented preclinical data for NKTR-255 at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2020 Annual Meeting, underscoring the potential for NKTR-255 as an innovative immunotherapeutic agent in the treatment of multiple myeloma.
In November 2020, Nektar presented new data from its immuno-oncology pipeline at the virtual 2020 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. Updated clinical data from the PIVOT-02 study metastatic melanoma cohort showed that bempegaldesleukin with nivolumab resulted in a durable clinical benefit with median progression-free survival of 30.9 months. NKTR-255 showed biological activity in the first patients treated in the monotherapy dose-escalation phase of the ongoing Phase 1 study in multiple myeloma and non-Hodgkin’s lymphoma. In addition, new data showed that the combination of TLR agonist candidate, NKTR-262, plus bempegaldesleukin alters the tumor micro-environment through activation of both the innate and adaptive arms of the immune system.
In November 2020, Nektar presented new data from its NKTR-358 program at the American College of Rheumatology (ACR) virtual meeting. Data from the Phase 1b study in patients with mild to moderate systemic lupus erythematosus (SLE) showed that NKTR-358 produced a dose-dependent increase in expression of regulatory T cell (Treg) activation markers, providing a rationale for continued development in SLE and other inflammatory indications.
In October 2020, Nektar initiated a Phase 1b clinical study of bempegaldesleukin in adult patients with mild COVID-19 infection. The randomized, double-blind, placebo-controlled trial is designed to assess the safety, tolerability, and pharmacokinetic and pharmacodynamic profile of bempegaldesleukin in adult patients with mild COVD-19.
In August 2020, Vaccibody AS and Nektar announced that the first patient had been dosed in the Phase 1/2a study evaluating bempegaldesleukin with VB10.NEO, Vaccibody’s personalized neoantigen cancer vaccine, in patients with advanced squamous cell carcinoma of the head and neck.
In June 2020, Nektar announced the presentation of results from the Phase 1b study evaluating multiple ascending doses of NKTR-358 at the Annual European Congress of Rheumatology (EULAR 2020) virtual meeting. The data showed that treatment with NKTR-358 was safe and well tolerated in patients with mild-to-moderate SLE and led to a marked and selective, dose-dependent expansion of regulatory T cells (Tregs) that was maintained over multiple administrations.
In May 2020, Nektar announced the publication of clinical data from its PIVOT-02 study evaluating bempegaldesleukin in combination with nivolumab in immunotherapy-naïve patients with advanced solid tumors, including melanoma, renal cell carcinoma (RCC) and non-small cell lung cancer. The data, published in Cancer Discovery, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), showed that bempegaldesleukin plus nivolumab resulted in encouraging overall response rates across multiple tumor types, independent of baseline PD-L1 expression, with responses continuing to deepen over time.
In April 2020, Nektar repaid the principal and accrued interest of its senior notes totaling $254.8 million.
In February 2020, Nektar announced the publication of preclinical bempegaldesleukin data in two manuscripts in Nature Communications showing how bempegaldesleukin works synergistically with multiple immune-based therapies to enhance T-cell-mediated tumor control.
In January 2020, Nektar and Bristol-Myers Squibb announced a new joint development plan that expanded the ongoing registrational program for bempegaldesleukin plus Opdivo from three ongoing registrational trials in first-line metastatic melanoma, first-line cisplatin-ineligible metastatic urothelial cancer and first-line metastatic RCC to include two additional registrational trials in adjuvant melanoma and muscle-invasive bladder cancer. In addition, the expanded development plan includes a Phase 1/2 study to evaluate bempegaldesleukin plus nivolumab in combination with a tyrosine-kinase inhibitor in first-line RCC in order to support a future registrational trial.
In January 2020, Nektar made the strategic business decision to withdraw its New Drug Application (NDA) for NKTR-181, an investigational opioid medicine in development for chronic pain and make no further investment into the program.
Conference Call to Discuss Fourth Quarter and Year-End 2020 Financial Results
Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time, Thursday, February 25, 2021.

This press release and a live audio-only Webcast of the conference call can be accessed through a link that is posted on the home page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through March 25, 2021.

In the event that any non-GAAP financial measure is discussed on the conference call that is not described in the press release, or explained on the conference call, related information will be made available on the Investors page at the Nektar website as soon as practical after the conclusion of the conference call.

On February 25, 2021 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a development-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported financial results for 2020 (Press release, Y-mAbs Therapeutics, FEB 25, 2021, View Source [SID1234575667]).

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"We are pleased with our 2020 financial results, especially seen in conjunction with the approval of DANYELZA, and the sale of our Priority Review Voucher for $105 million. For omburtamab, we are working closely with the FDA to address the Agency’s request for additional data, and we believe we have made progress and continue to work very hard on resubmitting the BLA. We also entered into a licensing agreement for Greater China for DANYELZA and omburtamab including milestones of up to $120 million and distribution agreements for DANYELZA and omburtamab for Eastern Europe, Russia and Israel, and thereby secured expanded access for children around the world to this important immunotherapy," stated Thomas Gad, founder, Chairman and President.

Dr. Claus Moller, Chief Executive Officer, continued, "We successfully completed a follow-on offering with gross proceeds of approximately $115.0 million earlier this week, and in parallel, we are making good progress in the clinic and have continued to advance the earlier stage programs in our pipeline. Nivatrotamab, our leading bispecific antibody, recently received ODD and RPDD from the FDA and our INDs for nivatrotamab in Small Cell Lung Cancer (Phase 2) and 177Lu-omburtamab-DTPA for medulloblastoma (Phase 1/2) and B7-H3 positive CNS/leptomeningeal metastasis in adults (Phase 1/2) were recently cleared by the FDA."

Fourth Quarter 2020 and Recent Corporate Developments

Subsequent to the end of the fourth quarter, on February 17, 2021, Y-mAbs announced the pricing of a follow-on shelf public offering, resulting in gross proceeds to the Company of approximately $115.0 million.

On December 28, 2020 Y-mAbs announced that it entered into a definitive agreement to sell its DANYELZA Priority Review Voucher to United Therapeutics Corporation for $105 million. Under the terms of the license agreement with Memorial Sloan Kettering, Y-mAbs will retain 60% of the net proceeds received from the sale. The transaction closed in January 2021.

On December 18, 2020, Y-mAbs announced that it had entered into a license agreement with SciClone Pharmaceuticals International Ltd to be the exclusive development and commercialization partner of DANYELZA and omburtamab for the treatment of pediatric patients in China, including upfront, approval and sales milestones of up to $120 million.

On December 18, 2020, Y-mAbs announced that it had entered into a distribution agreement with Swixx BioPharma AG to be the exclusive distributor of DANYELZA and omburtamab for the treatment of pediatric patients in Eastern Europe and Russia.

On December 9, 2020, Y-mAbs announced an update on DANYELZA data from the Company’s Study 201, which was presented at the ESMO (Free ESMO Whitepaper) Immunocology-Oncology Virtual Congress 2020.

On December 4, 2020, Y-mAbs announced that it had entered into a license and distribution agreement with Takeda Israel for the registration and commercialization of DANYELZA and omburtamab for the treatment of pediatric patients in the State of Israel.

On November 25, 2020, Y-mAbs announced that the FDA had approved DANYELZA for the treatment relapsed or primary refractory high-risk neuroblastoma.

On November 19, 2020, Y-mAbs announced that a clinical update of omburtamab for the treatment of diffuse intrinsic pontine glioma was presented at the SNO Virtual Annual Meeting.

On October 26, 2020, Y-mAbs announced that the FDA had cleared the Company’s IND for 177Lu-omburtamab-DTPA for the treatment of B7-H3 positive CNS and Leptomeningeal Metastasis from tumors in adult patients.

On October 14, 2020, Y-mAbs announced that the FDA had cleared the Company’s Investigational New Drug application for 177Lu-omburtamab-DTPA for the treatment of medulloblastoma, which is the most common type of primary brain cancer in children.

On October 7, 2020, Y-mAbs announced that the FDA has granted Orphan Drug Designation and Rare Pediatric Disease Designation for its leading bispecific antibody product candidate, nivatrotamab, for the treatment of neuroblastoma.

On October 5, 2020, Y-mAbs announced that it had received a Refusal to File letter from the FDA for the omburtamab BLA for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma. Subsequently, Y-mAbs has been in close dialog with the Agency to amend the BLA with the goal of resubmitting by the end of the second quarter or in the third quarter 2021.
Financial Results

Y-mAbs reported a net loss of $119.3 million, or ($2.97) per basic and diluted share, for the year ended December 31, 2020, compared to a net loss of $81.0 million, or ($2.30) per basic and diluted share, reported for the year ended December 31, 2019.

Revenues and Related Royalties Expense

Y-mAbs reported net revenues of $20.8 million for the year ended December 31, 2020 related to its licensing agreements in China and Israel. No revenues were reported for the year ended December 31, 2019.

Additionally, there were $2.2 million in royalties expense associated with the license revenue reported for the year ended December 31, 2020. No royalties expense was reported for the year ended December 31, 2019.

Operating Expenses

Research and Development
Research and development expenses were $93.7 million for the twelve months ended December 31, 2020, compared to $63.5 million for the twelve months ended December 31, 2019, an increase of $30.2 million. The increase in research and development expenses primarily reflects the following:

$13.4 million increase in personnel costs;
$13.2 million increase in milestones and license acquisition cost;
$1.1 million increase in professional and consulting fees; and
$1.6 million increase in outsourced services and supplies costs.
General and Administration
General and administrative expenses were $44.8 million for the twelve months ended December 31, 2020, compared to $19.5 million for the twelve months ended December 31, 2019, an increase of $25.3 million. The increase in general and administrative expenses primarily reflects the following:

$12.7 million increase in commercial infrastructure costs;
$8.9 million increase in personnel costs;
$2.1 million increase in business insurance; and
$2.1 million in professional fees.
Cash and Cash Equivalents

The Company had approximately $114.6 million in cash and cash equivalents as of December 31, 2020.

Webcast and Conference Call

The Company will host a conference call on Friday, February 26, 2021 at 9 a.m. Eastern Time. To participate in the call, please dial 877-407-0792 (domestic) or 201-689-8263 (international) and reference the access code 13716724. A webcast will be available at: View Source