On March 1, 2021 Viela Bio (Nasdaq:VIE), a biotechnology company dedicated to the discovery, development and commercialization of novel treatments for patients suffering from autoimmune and severe inflammatory diseases, reported financial results and provided program and business highlights for the fourth quarter and full year ended December 31, 2020 (Press release, Viela Bio, MAR 1, 2021, View Source [SID1234575846]).

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"2020 was a year of great progress for Viela, despite the many external challenges resulting from the COVID-19 global pandemic," said Bing Yao, Ph.D., Chief Executive Officer at Viela Bio. "Most significantly, we received FDA approval for UPLIZNA to treat adult patients with AQP4+ NMOSD and achieved solid product uptake, closed a successful public offering and continued to advance our full pipeline with the initiation of several clinical trials, including pivotal studies."

PROGRAM HIGHLIGHTS

UPLIZNA (inebilizumab-cdon)
UPLIZNA is a CD19-directed cytolytic antibody indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

UPLIZNA in NMOSD

In June 2020, UPLIZNA became the first and only FDA-approved B-cell-depleting humanized monoclonal antibody for the treatment of NMOSD, in adults who are anti-aquaporin-4 (AQP4) antibody positive.

Recently, Viela presented four scientific abstracts at the American Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) 2021 forum, reporting positive interim data from the open-label extension period (OLE) of the pivotal N-MOmentum trial in patients with NMOSD. Among the highlights, a reduction of attacks was sustained for the duration of the four-year observation period and no new safety signals were observed, regardless of the patient’s prior exposure to off-label therapy.

Regulatory applications have been filed for inebilizumab in several Asian countries based on results from the N-MOmentum study. If approved, Mitsubishi Tanabe Pharma Corporation (MTPC) and Hansoh Pharma—Viela’s partners in Asia—will be responsible for commercializing inebilizumab in their respective territories.
UPLIZNA in Additional Indications

Viela continues to enroll patients in two of its recently initiated Phase 3 trials for patients with myasthenia gravis (a chronic, rare autoimmune neuromuscular disease) and in IgG4-related disease (a group of disorders marked by tumor-like swelling and fibrosis of affected organs).

The Phase 2 trial for kidney transplant desensitization remains voluntarily paused due to the COVID-19 pandemic.
VIB4920
VIB4920 is an investigational fusion protein designed to bind to CD40L on activated T cells, blocking their interaction with CD40-expressing B cells.

Viela continues to advance its Phase 2b trial of VIB4920 in Sjögren’s syndrome and Phase 2 trials in patients with kidney transplant rejection and rheumatoid arthritis.
VIB7734
VIB7734 is an investigational monoclonal antibody designed to target and bind to ILT7, a cell surface molecule specific to pDCs, leading to their depletion. This depletion may also decrease other inflammatory cytokines such as TNF-alpha and IL-6, which are critical to the pathogenesis of a number of autoimmune diseases.

Viela reported final data at the virtual American College of Rheumatology (ACR) Convergence 2020 from its Phase 1b trial of VIB7734 confirming previously reported results. Data demonstrated that VIB7734 effectively reduced blood and skin plasmacytoid dendritic cells, leading to reduced type I Interferon levels in the blood and inflamed skin of patients with cutaneous lupus erythematosus (CLE). Based on these results, Viela selected systemic lupus erythematosus (SLE) as its lead indication. The Phase 2 trial for patients with SLE is anticipated to initiate in the H1 2021.

Viela anticipates results from its Phase 1 study of VIB7734 for the treatment of COVID-19 related acute injury in H1 2021.
BUSINESS UPDATES

On February 1, 2021, Viela Bio and Horizon Therapeutics announced that the companies entered into a definitive agreement for Horizon Therapeutics to acquire Viela Bio. The acquisition is structured as a two-step cash tender offer for all the issued and outstanding shares of Viela Bio, Inc. common stock at a price of $53.00 per share. Following successful completion of the tender offer, Horizon will acquire all remaining shares not tendered in the offer through a second step merger at the same price per share as in the tender offer. The transaction has been unanimously approved by Horizon’s and Viela’s boards of directors and is subject to the satisfaction of customary closing conditions.
Financial Results

Total net product revenue for the fourth quarter of 2020 was $9.4 million, resulting from sales of UPLIZNA. For the full year of 2020, total net product revenue was $11.7 million from sales of UPLIZNA. The Company did not generate product revenue in 2019.
For the fourth quarter of 2020, Viela reported a net loss of $33.4 million, compared to a net loss of $11.6 million for the fourth quarter of 2019. For the full year of 2020, Viela reported a net loss of $150.7 million, compared to a net loss of $86.4 million for the full year of 2019.
As of December 31, 2020, Viela had $378.5 million in cash, cash equivalents, and marketable securities and no outstanding debt.
Research and development expenses were $25.2 million for the fourth quarter of 2020, which include $1.4 million of non-cash stock-based compensation expenses. For the full year of 2020, research and development expenses were $103.3 million, which include $5.8 million of non-cash stock-based compensation expenses.
Selling, general and administrative expenses were $16.5 million for the fourth quarter of 2020, which include $1.7 million of non-cash stock-based compensation expenses. For the full year of 2020, selling, general and administrative expenses were $60.2 million, which include $6.5 million of non-cash stock-based compensation expenses.
Total operating expenses for the fourth quarter of 2020 totaled $43.1 million, compared to $43.0 million for the fourth quarter of 2019. Non-cash share-based compensation expenses totaled $3.1 million for the fourth quarter of 2020, compared to $1.4 million for the fourth quarter of 2019.
Total operating expenses for the full-year 2020 totaled $165.5 million, compared to $139.7 million for the full-year 2019. Non-cash share-based compensation expenses totaled $12.2 million for the full-year 2020, compared to $3.6 million for the full-year 2019.
Additional Information and Where to Find It

The tender offer described in this press release (the "Offer") has commenced, and this press release is neither a recommendation, nor an offer to purchase nor a solicitation of an offer to sell any shares of the common stock of Viela or any other securities. A tender offer statement on Schedule TO, including an offer to purchase, a letter of transmittal and related documents, was filed on February 12, 2020 with the SEC by Horizon, Horizon Therapeutics USA, Inc. and Teiripic Merger Sub, Inc., and a Solicitation/Recommendation Statement on Schedule 14D-9 was filed on the same day with the SEC by Viela. The offer to purchase shares of Viela common stock will only be made pursuant to the offer to purchase, the letter of transmittal and related documents filed as a part of the Schedule TO. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ BOTH THE TENDER OFFER STATEMENT AND THE SOLICITATION/RECOMMENDATION STATEMENT REGARDING THE OFFER, AS THEY MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME BECAUSE THEY CONTAIN IMPORTANT INFORMATION THAT INVESTORS AND SECURITY HOLDERS SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING TENDERING THEIR COMMON STOCK, INCLUDING THE TERMS AND CONDITIONS OF THE TENDER OFFER. Investors and security holders may obtain a free copy of these statements and other documents filed with the SEC at the website maintained by the SEC at www.sec.gov or by directing such requests to the Information Agent for the Offer, which will be named in the tender offer statement. Investors may also obtain, at no charge, the documents filed or furnished to the SEC by Viela under the "Investors/Media" section of Viela’s website at www.vielabio.com.

On March 1, 2021 Omeros Corporation (Nasdaq: OMER), a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers, reported recent highlights and developments as well as financial results for the fourth quarter and year ended December 31, 2020, which include (Press release, Omeros, MAR 1, 2021, View Source [SID1234575845]):

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Revenues for the fourth quarter of 2020 were $10.6 million compared to $26.1 million in the third quarter of 2020. The decrease from the prior period is primarily due to the expiration, on October 1, 2020, of pass-through reimbursement for OMIDRIA (phenylephrine and ketorolac intraocular solution) 1%/0.3%. In December, the Centers for Medicare and Medicaid Services (CMS) confirmed that OMIDRIA qualifies for separate payment, effective retroactively as of October 1, 2020, when used in the ASC setting under its policy for non-opioid pain management surgical drugs.
Full year 2020 OMIDRIA revenues were $73.8 million, compared to $111.8 million in the prior year. The decrease was due to the reduction in cataract surgeries performed as a result of the COVID-19 pandemic and uncertainty regarding Medicare Part B reimbursement for OMIDRIA after its pass-through status expired on October 1, 2020.
At December 31, 2020, the company had cash, cash equivalents and short-term investments available for operations of $135.0 million.
Omeros’ Biologics License Application (BLA) for narsoplimab was accepted and granted priority review by the U.S. Food and Drug Administration (FDA) for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA or TA-TMA). The Prescription Drug User Fee Act (PDUFA) date is July 17, 2021.
Narsoplimab entered the I-SPY COVID-19 platform trial sponsored by Quantum Leap Healthcare Collaborative, which is evaluating drugs and investigational products for the treatment of critically ill COVID-19 patients. Narsoplimab is the only complement inhibitor invited to participate in this trial.
Initial data are expected next quarter from the Phase 1 clinical trial evaluating the pharmacokinetics, pharmacodynamics, safety and tolerability of OMS906, the company’s inhibitor of MASP-3, the key activator of the alternative pathway of complement.
"2020 was a challenging year for everyone, but our team’s list of accomplishments is impressive – submission of the BLA for transplant-associated TMA and life-saving treatment of critically ill COVID-19 patients with narsoplimab, reinstatement of separate payment for our ophthalmic product OMIDRIA, entry into the clinic for our MASP-3 inhibitor OMS906, and the addition of substantial working capital to our balance sheet," said Gregory A. Demopulos, M.D., Omeros’ chairman and chief executive officer. "As we entered the new year, the team maintained its momentum, continuing to build on these achievements. The BLA was granted priority review and our commercial launch plan is on track to bring narsoplimab to patients as soon as we receive approval. The only complement inhibitor in the I-SPY COVID-19 trial, narsoplimab is the focus of growing attention from international government agencies and global organizations in the fight against COVID, and we are advancing the drug across IgA nephropathy, aHUS and an expanding set of indications. Once again secured, OMIDRIA revenues are increasing and will continue to provide working capital to fund our pipeline, including OMS906, which remains on schedule to read out initial data next quarter, and the rest of our programs. 2021 has started strong, and we expect that it will finish even stronger."

Fourth Quarter and Recent Developments

Narsoplimab is Omeros’ lead antibody targeting MASP-2 to inhibit activation of the lectin pathway of complement and is under review by FDA for the treatment of TA-TMA and is in Phase 3 clinical programs in immunoglobulin A (IgA) nephropathy, atypical hemolytic uremic syndrome (aHUS) and critically ill COVID-19 patients. Recent narsoplimab-related developments include the following:
FDA accepted and granted priority review to the BLA for narsoplimab for the treatment of TA-TMA and set a PDUFA date of July 17, 2021. FDA also indicated in its filing letter that FDA is not currently planning to hold an advisory committee meeting to discuss the BLA. Priority review is granted to applications for therapies that, if approved, would be significant improvements in the safety or effectiveness of the treatment, prevention or diagnosis of serious conditions.
Omeros completed the application for a New Technology Add-On Payment (NTAP) for narsoplimab, which, if granted, would provide for special payment to hospitals for narsoplimab when administered in the hospital inpatient setting. The NTAP interim rule is expected in the second quarter of 2021. As part of our reimbursement efforts, we applied, and received preliminary support from CMS, for ICD-10 procedural and diagnostic codes in connection with the use of narsoplimab in the treatment of TA-TMA.
At the 2020 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, Omeros made a presentation directed to the pharmacodynamics of narsoplimab in humans and primates, which subsequently was published in the peer-reviewed journal Blood.
Omeros also had a significant presence at the 2021 Annual Meeting of the American Society of Transplantation and Cellular Therapy in February, including a podium presentation by Dr. Samer Khaled of City of Hope on the pivotal clinical trial results with narsoplimab in TA-TMA.
Narsoplimab entered the I-SPY COVID-19 platform trial, which is evaluating drugs and investigational products for the treatment of critically ill COVID-19 patients. Narsoplimab is the only complement inhibitor invited to participate in this trial. The trial utilizes Quantum Leap Healthcare Collaborative’s adaptive platform trial design, which is intended to increase trial efficiency by minimizing the number of participants and time required to evaluate potential treatments.
Omeros has continued treating COVID-19 patients with narsoplimab under compassionate use – to date, nine more in Bergamo, Italy and four in the U.S. All of these patients prior to receiving narsoplimab were severely ill, intubated, had multiple comorbidities, and had failed other therapies, including anti-virals, targeted anti-inflammatory therapeutics, convalescent plasma and steroids. Following treatment with narsoplimab, the laboratory improvements and clinical outcomes of these patients are consistent with those seen in the initial cohort of Bergamo patients and published in Immunobiology. A manuscript detailing the findings and clinical outcomes of the second cohort of patients is in preparation.
Recent developments regarding Omeros’ ophthalmic drug OMIDRIA include the following:
In December 2020, CMS confirmed that OMIDRIA qualifies for separate payment in the ASC setting under its policy for non-opioid pain management surgical drugs, effective retroactively from October 1, 2020, when pass-through reimbursement for OMIDRIA expired.
A new study showing that OMIDRIA significantly decreases retinal thickness and macular edema caused by cataract surgery has been selected for a podium presentation at the 2021 Congress of American Society of Cataract and Refractive Surgery in August. This study further confirms previously published clinical data showing that OMIDRIA significantly reduces the incidence of sight-threatening cystoid macular edema while precluding the need for perioperative steroids.
Updates regarding Omeros’ other development programs and platforms include the following:
Initial data are expected next quarter from the Phase 1 clinical trial evaluating OMS906, the company’s inhibitor of MASP-3, the key activator of the alternative pathway of complement. The placebo-controlled, double-blind, single-ascending-dose and multiple-ascending-dose trial is assessing the pharmacokinetics, pharmacodynamics, safety and tolerability of OMS906. Omeros has completed all of the intravenous dosing cohorts in the single ascending dose study and expects to begin subcutaneous dosing this month.
Financial Results

Fourth Quarter 2020

For the fourth quarter of 2020, OMIDRIA revenues were $10.6 million. This compares to OMIDRIA revenues of $26.1 million for the third quarter of 2020. The decrease was primarily due to the expiration of pass-through reimbursement for OMIDRIA on October 1, 2020 and the uncertainty around separate payment for OMIDRIA until CMS confirmed in December that OMIDRIA qualifies for separate payment when used in the ASC setting under CMS’ policy for non-opioid pain management surgical drugs.

Total costs and expenses for the fourth quarter of 2020 were $44.4 million, compared to $51.5 million in the preceding quarter. The decrease was primarily due to a technology license payment related to the OMS906 program in that earlier quarter.

For the three months ended December 31, 2020, Omeros reported a net loss of $37.3 million, or $0.60 per share, which included non-cash expenses of $3.5 million, or $0.06 per share. This compares to the prior year fourth quarter, when Omeros reported a net loss of $29.2 million or $0.58 per share, which included non-cash expenses of $6.3 million, or $0.12 per share.

As of December 31, 2020, Omeros had $135.0 million of cash, cash equivalents and short-term investments available for operations.

Full Year 2020

Revenues for 2020 were $73.8 million compared to $111.8 million for 2019. The decrease was due to the reduction in cataract surgeries performed due to the COVID-19 pandemic and the uncertainty regarding Medicare Part B reimbursement for OMIDRIA after its pass-through status expired on October 1, 2020. In December 2020, CMS confirmed separate payment for OMIDRIA in the ASC setting effective retroactively as of October 1.

For the year ending December 31, 2020, total costs and expenses were $184.4 million, compared to $175.2 million in the prior year.

Conference Call Details

Omeros’ management will host a conference call to discuss the financial results and to provide an update on business activities. The call will be held today at 4:30 p.m. Pacific Time; 1:30 p.m. Eastern Time. To access the live conference call via phone, please dial (844) 831-4029 from the United States and Canada or (920) 663-6278 internationally. The participant passcode is 3399452. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available for one week following the call and may be accessed by dialing (855) 859-2056 from the United States and Canada or (404) 537-3406 internationally. The replay passcode is 3399452.

To access the live or subsequently archived webcast of the conference call on the internet, go to the company’s website at www.omeros.com and select "Events" under the Investors section of the website. To access the live webcast, please connect to the website at least 15 minutes prior to the call to allow for any software download that may be necessary.

On March 1, 2021, Halozyme Therapeutics, Inc. (the "Company," "we," "us" or "our") reported that it completed its previously announced sale of $805.0 million in aggregate principal amount of 0.25% Convertible Senior Notes due 2027 (the " Convertible Notes"), including $105.0 million in aggregate principal amount of 0.25% Convertible Senior Notes due 2027 to be purchased pursuant to the exercise by the initial purchasers of the Convertible Notes (the "Initial Purchasers") of the option to purchase additional Securities in a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Filing, 8-K, Halozyme, MAR 1, 2021, View Source [SID1234575844]). The Convertible Notes were issued under an indenture, dated as of March 1, 2021, (the "Indenture") between the Company and The Bank of New York Mellon Trust Company, N.A., as trustee (the "Trustee"). The Company offered and sold the Convertible Notes in reliance on the exemption from registration provided by Section 4(a)(2) of the Securities Act. The Initial Purchasers offered and sold the Convertible Notes to "qualified institutional buyers" pursuant to the exemption from registration provided by Rule 144A under the Securities Act. The offer and sale of the Convertible Notes and the shares of common stock issuable upon conversion of the Convertible Notes have not been registered under the Securities Act, or the securities laws of any other jurisdiction, and the Convertible Notes and such shares may not be offered or sold absent registration or an applicable exemption from registration requirements, or in a transaction not subject to, such registration requirements.

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The Company received net proceeds from the offering of approximately $784.3 million. The Company used a portion of the net proceeds of the offering to enter into privately negotiated agreements with certain holders of its outstanding 1.25% convertible senior notes due 2024 (the "Existing Convertible Notes") to exchange their Existing Convertible Notes for a combination of cash and shares of its common stock through privately negotiated transactions entered into concurrently with or shortly after the offering (the "Note Repurchases"). In connection with the Note Repurchases, the Company paid approximately $370.2 million in cash, which includes accrued interest, and issued approximately 9.08 million shares of its common stock, to settle such exchanges. In addition, the Company plans to use up to $75.0 million of the net proceeds from the offering to repurchase shares of its common stock under its existing stock repurchase program (the "Share Repurchases").

The Company intends to use the remainder of the net proceeds from the offering for general corporate purposes, including other repurchases of the Company’s common stock from time to time under its existing stock repurchase program, working capital, capital expenditures, potential acquisitions and strategic transactions.

The Convertible Notes will pay interest semi-annually in arrears on March 1st and September 1st of each year at an annual rate of 0.25% and will be convertible into cash, and, if applicable, shares of the Company’s common stock, at the Company’s election, based on the applicable conversion rate at such time. The Convertible Notes are general unsecured obligations of the Company and will rank senior in right of payment to all of the Company’s indebtedness that is expressly subordinated in right of payment to the Convertible Notes, will rank equally in right of payment with all of the Company’s existing and future liabilities that are not so subordinated, will be effectively junior to any of the Company’s secured indebtedness to the extent of the value of the assets securing such indebtedness and will be structurally subordinated to all indebtedness and other liabilities (including trade payables) of the Company’s current or future subsidiaries.

Holders may convert their Convertible Notes at their option only in the following circumstances: (1) during any calendar quarter commencing after the calendar quarter ending on June 30, 2021, if the last reported sale price per share of the Company’s common stock exceeds 130% of the conversion price for each of at least 20 trading days during the 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding calendar quarter; (2) during the five consecutive business days immediately after any five consecutive trading day period (such five consecutive trading day period, the "measurement period") in which the trading price per $1,000 principal amount of notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price per share of Company’s common stock on such trading day and the conversion rate on such trading day; (3) upon the occurrence of certain corporate events or distributions on Company’s common stock, as described in the offering memorandum; (4) if we call such notes for redemption; and (5) at any time from, and including, September 1, 2026 until the close of business on the scheduled trading day immediately before the maturity date. The Notes will be convertible, regardless of the foregoing circumstances, at any time from, and including, September 1, 2026 until the close of business on the scheduled trading day immediately preceding the maturity date.

Upon conversion the Company will pay cash or deliver, as the case may be, cash, shares of the Company’s common stock or a combination of cash and shares of the Company’s common stock, at the Company’s election. The initial conversion rate for the Convertible Notes will be 12.9576 shares of common stock per $1,000 in principal amount of Convertible Notes, equivalent to a conversion price of approximately $77.17 per share of common stock. The conversion rate will be subject to adjustment in some events but will not be adjusted for any accrued or unpaid interest.

Subject to certain exceptions, holders may require the Company to repurchase, for cash, all or part of their Convertible Notes upon a "Fundamental Change" (as defined in the Indenture) at a price equal to 100% of the principal amount of the Convertible Notes being repurchased plus any accrued and unpaid interest, if any, up to, but excluding, the "Fundamental Change Repurchase Date" (as defined in the Indenture). In addition, upon a "Make-Whole Fundamental Change" (as defined in the Indenture) prior to the maturity date of the Convertible Notes, the Company will, in some cases, increase the conversion rate for a holder that elects to convert its Convertible Notes in connection with such Make-Whole Fundamental Change. The Company may not redeem the Convertible Notes prior to March 1, 2024 and on or before the 30th scheduled trading day immediately before the maturity date.

The Indenture contains certain events of default after which the Convertible Notes may be due and payable immediately. Such events of default include, without limitation, the following: (1) a default in the payment when due (whether at maturity, upon redemption or repurchase upon fundamental change or otherwise) of the principal of, or the redemption price or fundamental change repurchase price for, any Convertible Note; (2) a default for 30 days in the payment when due of interest on any Convertible Note; (3) the Company’s failure to deliver, when required by the Indenture, a fundamental change notice or other notices pursuant to the Indenture; (4) a default in the Company’s obligation to convert a Convertible Note in accordance with the Indenture upon the exercise of the conversion right with respect thereto, if such default is not cured within two business days after its occurrence; (5) a default in the Company’s obligations described in the Indenture with respect to consolidation, merger and sale of assets of the Company; (6) a default in any of the Company’s obligations or agreements under the Indenture or the Convertible Notes (other than a default set forth in the preceding (1), (2), (3), (4) or (5)) where such default is not cured or waived within 60 days after notice to the Company by the Trustee, or to the Company and the Trustee by holders of at least 25% of the aggregate principal amount of Convertible Notes then outstanding, which notice must specify such default, demand that it be remedied and state that such notice is a "notice of default"; (7) a default by the Company or any of the Company’s subsidiaries with respect to any one or more mortgages, agreements or other instruments under which there is outstanding, or by which there is secured or evidenced, any indebtedness for money borrowed of at least $30.0 million (or its foreign currency equivalent) in the aggregate of the Company or any of the Company’s subsidiaries, whether such indebtedness exists as of the date the Company first issues the Convertible Notes or is thereafter created, where such default: (x) constitutes a failure to pay the principal of, or premium or interest on, any of such indebtedness when due and payable at its stated maturity, upon required repurchase, upon declaration of acceleration or otherwise, in each case after the expiration of any applicable grace period; or (y) results in such indebtedness becoming or being declared due and payable before its stated maturity, in each case where such default is not cured or waived within 30 days after notice to the Company by the Trustee or to the Company and the Trustee by holders of at least 25% of the aggregate principal amount of Convertible Notes then outstanding; (8) one or more final judgments being rendered against the Company or any of the Company’s subsidiaries for the payment of at least $30.0 million (or its foreign currency equivalent) in the aggregate (excluding any amounts covered by insurance), where such judgment is not discharged or stayed within 60 days after (i) the date on which the right to appeal the same has expired, if no such appeal has commenced; or (ii) the date on which all rights to appeal have been extinguished; and (9) certain events of bankruptcy, insolvency and reorganization with respect to the Company or any of the Company’s "significant subsidiaries", as defined in the Indenture.

The foregoing description of the Indenture and Convertible Notes is qualified in its entirety by reference to the text of the Indenture and the Form of Convertible Note, copies of which are attached as Exhibits 4.1 and 4.2, respectively, to this Current Report on Form 8-K and are incorporated herein by reference.

On March 1, 2021 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a pioneer in T-cell immunotherapy, leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with serious diseases including solid tumors, hematologic cancers and autoimmune diseases, reported financial results for the fourth quarter and full year 2020, recent business highlights and key catalysts over the next 18 months (Press release, Atara Biotherapeutics, MAR 1, 2021, View Source [SID1234575843]).

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"Atara had a very strong year in 2020, delivering on key milestones across the Company’s three strategic priorities," said Pascal Touchon, President and Chief Executive Officer of Atara. "We anticipate several additional key catalysts over the next 18 months, especially the completion of the tab-cel BLA filing in Q3 2021, significant advancement on the ATA188 program – including long-term clinical data update from the Phase 1 study as well as enrollment progress in the Phase 2 RCT enabling an interim analysis, and preclinical and clinical progress on both the mesothelin and CD19 CAR T programs."

Tabelecleucel (tab-cel) for Post-transplant Lymphoproliferative Disease (PTLD)

The Company has completed the preclinical module 4 and is ready to initiate a rolling BLA with this module once the FDA decides on a procedural question related to how the historical non-pivotal data should be presented in the BLA submission
Atara is making progress through active and productive discussions with FDA on the final content of the CMC module 3
Atara is on track to complete a rolling BLA submission for patients with EBV+ PTLD with the clinical module in Q3 2021
Atara plans to submit an EU Marketing Authorization Application (MAA) for patients with EBV+ PTLD in Q4 2021
Data from the Phase 3 ALLELE study will be presented at an appropriate congress in Q4 2021
The Company recently presented transcriptional data for tab-cel demonstrating consistency of the product’s activation profile irrespective of donor and consistent enrichment of receptors targeting EBV-driven diseases, at the 2021 Transplantation & Cellular Therapy (TCT) Meeting
The Company has confirmed an HLA match for 89 percent of patients eligible for screening in the Phase 3 ALLELE study over the last 12 months and continues to build a robust inventory for clinical studies and commercialization
The Company is investing further in U.S. commercial readiness activities in anticipation of planned tab-cel approval and launch in H1 2022
In addition, Atara is seeking a partner for the commercialization of tab-cel outside the U.S.
Tabelecleucel (tab-cel) for Potential Additional Indications

Atara is actively opening sites in the Phase 2 multi-cohort study including patients with other EBV-driven cancers
ATA188 for Progressive Forms of Multiple Sclerosis (MS)

Atara continues to make progress with enrollment in the ATA188 Phase 2 randomized, double-blind, placebo-controlled trial (RCT) following enrollment of its first patient in June 2020
The Company discussed updates to the design of the RCT with the FDA and gained alignment on the following for this RCT, as well as potential registrational studies:
A disability improvement endpoint is appropriate, with the FDA articulating a preference for EDSS improvement
The criteria used to enroll the study population of non-active secondary progressive MS (SPMS) and non-active primary progressive MS (PPMS) are appropriate
This Phase 2 RCT should run for at least 12 months, and a properly conducted interim analysis is appropriate
Based on this alignment, the Company has amended the study protocol, changing the primary endpoint of the study to EDSS disability improvement and increasing the number of patients to 80 to account for this change, while maintaining the biological and functional endpoints
Atara will conduct an interim analysis (IA) in H1 2022 including efficacy and safety from the Phase 2 RCT in patients with progressive forms of MS, and following the IA, expects to complete enrollment of the study in H1 2022
The Company plans to present translational data from the Phase 1a study and long-term two-year clinical data from the Phase 1a open-label extension (OLE) in H2 2021
Atara presented a poster on an innovative testing solution that enables detection and quantification of non-engineered allogeneic T-cell therapies for use in ATA188 clinical development, at the recent 2021 TCT Meeting
CAR T Programs

ATA2271/ATA3271 (Solid Tumors Over-Expressing Mesothelin)

Atara announced and has initiated a strategic collaboration with Bayer through an exclusive worldwide license agreement and research, development and manufacturing collaboration for its mesothelin-directed CAR T-cell therapies (ATA2271 and ATA3271) for the treatment of solid tumors
In collaboration with Atara, Memorial Sloan Kettering Cancer Center (MSK) has enrolled several patients into the open-label, single-arm Phase 1 clinical study of ATA2271, the Company’s second-generation autologous CAR T therapy targeting mesothelin (MSLN) that incorporates for the first time both a novel 1XX co-stimulatory domain for improving functional persistence and a PD-1 DNR (dominant-negative programmed death-1 receptor) for intrinsic check-point inhibition for the treatment of advanced mesothelioma
Atara and MSK expect to present first Phase 1 data for ATA2271 in Q4 2021
The Company presented preclinical findings that demonstrate potent antitumor activity, functional persistence, and low toxicity profile of ATA3271 supporting further clinical investigation, at the November 2020 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting (SITC) (Free SITC Whitepaper)
ATA3219 (B-cell Malignancies)

Atara plans to submit an IND for ATA3219, its allogeneic CAR T for patients with B-cell malignancies, in Q4 2021 or Q1 2022
The Company presented promising preclinical data showing potent antitumor activity both in vitro and in vivo, with long-term functional persistence and no evidence of allocytoxicity in vivo, at the December 2020 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting
Fourth Quarter and Full Year 2020 Financial Results

Cash, cash equivalents and short-term investments as of December 31, 2020 totaled $500.7 million, as compared to $259.1 million as of December 31, 2019
The December 31, 2020 cash balance included $164.5 million of net proceeds from the sale of 5,102,041 shares of common stock and pre-funded warrants to purchase 2,040,816 shares of common stock in an underwritten public offering in December 2020, $52.9 million in payments from the Bayer collaboration (excluding $7.1 million of refundable withholding taxes), and $10.9 million from the sale of 675,530 shares of common stock through the Company’s ATM facility, partially offset by other operating cash burn
Atara believes that its cash as of December 31, 2020 together with projected revenue from U.S. tab-cel sales is sufficient to fund its operations into 2023, including expenses related to the BLA filing and commercial launch of tab-cel in the U.S.
Net cash used in operating activities was $4.1 million and $180.8 million for the fourth quarter and fiscal year 2020, respectively, as compared to $58.7 million and $235.6 million for the same periods in 2019; the reduction in operating cash usage in the fourth quarter of 2020 was primarily due to $52.9 million of payments received from Bayer
Atara reported net losses of $81.3 million, or $0.95 per share, and $306.6 million, or $4.15 per share, for the fourth quarter and fiscal year 2020, respectively, as compared to $78.5 million, or $1.36 per share, and $291.0 million, or $5.67 per share, for the same periods in 2019
Total operating expenses include non-cash expenses of $13.6 million and $59.4 million for the fourth quarter and fiscal year 2020, respectively, as compared to $14.0 million and $58.8 million for the same periods in 2019
Research and development expenses were $65.6 million and $244.7 million for the fourth quarter and fiscal year 2020, respectively, as compared to $61.6 million and $216.1 million for the same periods in 2019
The increase in the fourth quarter 2020 was primarily due to sublicense fees related to the Bayer license agreement and higher employee-related and overhead costs from increased headcount
The increase in fiscal year 2020 was primarily due to higher employee-related and overhead costs from increased headcount, sublicense fees related to the Bayer license agreement and increased spending on tab-cel clinical trials, process performance qualification activities and preparations for our tab-cel BLA filing
Research and development expenses include $7.2 million and $31.5 million of non-cash stock-based compensation expenses for the fourth quarter and fiscal year 2020, respectively, as compared to $7.0 million and $26.8 million for the same periods in 2019
General and administrative expenses were $16.1 million and $64.4 million for the fourth quarter and fiscal year 2020, respectively, as compared to $18.1 million and $79.6 million for the same periods in 2019; the decreases in the fourth quarter and fiscal year 2020 were primarily due decreases in outside services costs and lower non-cash stock-based compensation expenses
General and administrative expenses include $4.3 million and $19.8 million of non-cash stock-based compensation expenses for the fourth quarter and fiscal year 2020, respectively, as compared to $5.0 million and $24.9 million for the same periods in 2019

On March 1, 2021 FibroGen, Inc. (NASDAQ: FGEN) reported financial results for the fourth quarter and full year 2020 and provided an update on the company’s recent developments (Press release, FibroGen, MAR 1, 2021, View Source [SID1234575842]).

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"While disappointed with the news today, FibroGen and AstraZeneca remain confident in the efficacy and safety profile of roxadustat based on positive results from a global Phase 3 program encompassing more than 8,000 patients," said Enrique Conterno, Chief Executive Officer, FibroGen. "With strong roxadustat commercial results in China, we continue to drive forward in our three main areas of focus: ensuring the regulatory and commercial success of roxadustat; accelerating the development of pamrevlumab in the three high-value indications of locally advanced unresectable pancreatic cancer (LAPC), Duchenne muscular dystrophy (DMD), and idiopathic pulmonary fibrosis (IPF); and building our research capabilities in both hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology while adding to our clinical development pipeline."

Key Events in 2020 and Other Developments

Roxadustat

Regulatory:
The Cardiovascular and Renal Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) will hold an advisory committee (AdCom) meeting to review the new drug application (NDA) for roxadustat in the U.S. The companies have not received a confirmed AdCom meeting date from the FDA.
In November 2020, Japan’s Ministry of Health, Labour and Welfare (MHLW) approved EVRENZO (roxadustat) for the treatment of anemia of CKD in adult patients not on dialysis.
The Marketing Authorization Application (MAA) for roxadustat for the treatment of anemia in adult patients with CKD was accepted for regulatory review by the European Medicines Agency (EMA) in May 2020, with an expected decision by mid-2021.
Clinical:
Enrollment was completed in the WHITNEY US Phase 2 roxadustat clinical trial in chemotherapy-induced anemia (CIA) in 4Q 2020.
Enrollment continued in the MATTERHORN Phase 3 roxadustat clinical trial in anemia associated with myelodysplastic syndromes (MDS).
Enrollment was completed in the ASPEN and DENALI Phase 3b roxadustat clinical trials in dialysis patients with anemia of CKD.
Publications / Presentations:
Roxadustat data was presented at the following scientific meetings in 2020:
The National Kidney Foundation Spring Clinical Meeting
The 57th European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Virtual Congress
The American Society of Nephrology (ASN) Kidney Week 2020 Reimagined
The 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition
Roxadustat Phase 3 manuscripts on the treatment of anemia of CKD were published in peer-reviewed medical journals:
Pooled Analysis of Roxadustat for Anemia in Patients with Kidney Failure Incident to Dialysis Kidney International Reports
Roxadustat for Chronic Kidney Disease-related Anemia in Non-dialysis Patients Kidney International Reports
Roxadustat for Treating Anemia in Patients with CKD Not on Dialysis: Results from a Randomized Phase 3 Study Journal of the American Society of Nephrology
Roxadustat for the Treatment of Anemia in Chronic Kidney Disease (CKD) Patients Not on Dialysis: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study (ALPS) Nephrology Dialysis Transplantation
Roxadustat for anemia in patients with end-stage renal disease incident to dialysis Nephrology Dialysis Transplantation
Pamrevlumab

Enrollment continued in the LAPIS Phase 3 clinical trial of pamrevlumab in patients with locally advanced unresectable pancreatic cancer (LAPC).
Enrollment continued in the LELANTOS Phase 3 clinical trial of pamrevlumab in non-ambulatory patients with Duchenne muscular dystrophy (DMD).
Enrollment continued in the ZEPHYRUS Phase 3 clinical trial of pamrevlumab in patients with idiopathic pulmonary fibrosis (IPF).
In December, we initiated a second Phase 3 clinical trial of pamrevlumab, ZEPHYRUS-2, in patients with idiopathic pulmonary fibrosis (IPF).
Upcoming Data Catalysts

Data from the Phase 2 WHITNEY study of roxadustat in chemotherapy-induced anemia (CIA) expected 2H 2021.
Data from the Phase 3 MATTERHORN study of roxadustat in anemia of myelodysplastic syndromes (MDS) expected 1H 2022.
Resection data from the Phase 3 LAPIS study of pamrevlumab in locally advanced pancreatic cancer (LAPC) expected 2H 2022.
Data from the Phase 3 LELANTOS study of pamrevlumab in Duchenne muscular dystrophy (DMD) expected 2H 2022.
2020 Key Executive Additions

Percy Carter, Ph.D., was appointed to the newly created position of Chief Scientific Officer.
Mark Eisner, M.D., M.P.H., was appointed as Chief Medical Officer.
Thane Wettig was appointed to the newly created position of Chief Commercial Officer.
Financial

Total revenue for the fourth quarter of 2020 was $65.0 million, as compared to $8.0 million for the fourth quarter of 2019. The current quarter revenue consists of net product revenues of $29.2 million for roxadustat sales in China, $21.5 million in development revenue, and $14.3 million in license revenue related to NDD approval in Japan. Total net roxadustat sales in China for 2020 were $72.5 million.
Net loss for the fourth quarter of 2020 was $58.6 million, or $0.64 net loss per basic and diluted share, compared to a net loss of $98.1 million, or $1.12 net loss per basic and diluted share one year ago.
Net loss for the year was $189.3 million, or $2.11 net loss per basic and diluted share, compared to a net loss of $77.0 million, or $0.89 net loss per basic and diluted share one year ago.
At December 31, 2020, FibroGen had $732.1 million in cash, restricted time deposits, cash equivalents, investments, and receivables.
Based on our latest forecast, we estimate our 2021 ending cash to be in the range of $660 to $670 million.
The China Agreement with AstraZeneca was amended in July 2020 to maximize the economic value of the roxadustat franchise for both parties with more predictable economics and profitability for FibroGen.
Conference Call and Webcast Details
FibroGen will host a conference call and webcast today, Monday, March 1, 2021, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss financial results and provide a business update. A live audio webcast of the call may be accessed in the investor section of the company’s website, www.fibrogen.com. To participate in the conference call by telephone, please dial 1 (877) 658-9081 (U.S. and Canada) or 1 (602) 563-8732 (international), reference the FibroGen fourth quarter and full year 2020 financial results conference call, and use confirmation number 3055327. A replay of the webcast will be available shortly after the call for a period of four weeks. To access the replay, please dial 1 (855) 859-2056 (domestic) or 1 (404) 537-3406 (international), and use passcode 3055327.

About Roxadustat
Roxadustat, an oral medicine, is the first in a new class of medicines, HIF-PH inhibitors that promote erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin; improved iron absorption and mobilization; and downregulation of hepcidin. Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia (CIA).

Roxadustat is approved in China, Japan, and Chile for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). In Europe, the Marketing Authorization Application for roxadustat for the treatment of anemia in with chronic kidney disease (CKD) in NDD and DD patients was filed by Astellas Pharma Inc. (Astellas) and accepted by the European Medicines Agency for review in May 2020. Several other licensing applications for roxadustat have been submitted by Astellas and AstraZeneca to regulatory authorities across the globe, and are currently in review.

Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in territories including Japan, Europe, Turkey, Russia and the Commonwealth of Independent States, the Middle East, and South Africa. FibroGen and AstraZeneca are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in the U.S., China, other markets in the Americas, in Australia/New Zealand, and Southeast Asia.

About Pamrevlumab
Pamrevlumab is a first-in-class antibody developed by FibroGen that inhibits the activity of connective tissue growth factor (CTGF), an important biological mediator in fibrotic and proliferative disorders. Pamrevlumab is in Phase 3 clinical development for the treatment of locally advanced unresectable pancreatic cancer (LAPC), Duchenne muscular dystrophy (DMD), and idiopathic pulmonary fibrosis (IPF). For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.