On August 9, 2021 Idera Pharmaceuticals, Inc. ("Idera" or the "Company") (Nasdaq: IDRA) reported its financial and operational results for the second quarter ended June 30, 2021 (Press release, Idera Pharmaceuticals, AUG 9, 2021, View Source [SID1234586119]).

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"Our goal is to add new development or commercial-stage assets to Idera’s portfolio, and our team is very encouraged by the high quality and quantity of opportunities we have been presented with," stated Vincent Milano, Idera’s Chief Executive Officer. "Several of these prospects continue to advance, and we remain optimistic in Idera’s future potential."

Added Mr. Milano, "We also maintain our interest in the potential of tilsotolimod. Enrollment is complete and we continue to treat patients in the second stage of ILLUMINATE-206, our Phase 2 study in combination with BMS’s nivolumab and ipilimumab for patients with microsatellite-stable colorectal cancer. We also continue to support AbbVie in the form of study drug in their trial for patients with head and neck squamous cell carcinoma."

Second Quarter Financial Results
Research and development expenses for the three months ended June 30, 2021 totaled $3.9 million, compared to $5.4 million for the same period in 2020. General and administrative expense for the three months ended June 30, 2021 totaled $2.5 million compared to $2.6 million for the same period in 2020. Restructuring costs for the three months ended June 30, 2021 totaled approximately $1.2 million and relate to a reduction in force initiated in April 2021 to better align our workforce to our ongoing operational and business development activities. No such costs were incurred during the three months ended June 30, 2020. Additionally, during the three months ended June 30, 2020, we recorded $0.9 million and $15.3 million non-cash warrant revaluation loss and non-cash future tranche right revaluation loss, respectively, related to securities issued in connection with our December 2019 private placement transaction. No such non-cash losses were recognized in the three months ended June 30, 2021.

As a result of the factors above, net loss applicable to common stockholders for the three months ended June 30, 2021 was $7.6 million or $0.15 per basic and diluted share compared to a net loss applicable to common stockholders of $24.2 million or $0.72 per basic and diluted share for the same period in 2020.
Excluding the non-cash loss of approximately $16.3 million for the three months ended June 30, 2020 related to the securities issued in connection with the December 2019 private placement transaction, net loss applicable to common stockholders was $8.0 million.

On August 9, 2021, Amgen Inc. (the "Company") reported that it issued and sold $1,250,000,000 aggregate principal amount of its 1.650% Senior Notes due 2028 (the "2028 Notes"), $1,250,000,000 aggregate principal amount of its 2.000% Senior Notes due 2032 (the "2032 Notes"), $1,150,000,000 aggregate principal amount of its 2.800% Senior Notes due 2041 (the "2041 Notes") and $1,350,000,000 aggregate principal amount of 3.000% Senior Notes due 2052 (the "2052 Notes" and, together with the 2028 Notes, the 2032 Notes and the 2041 Notes, the "Notes") (Filing, 8-K, Amgen, AUG 9, 2021, View Source [SID1234586118]). The Notes are registered under an effective Registration Statement on Form S-3 (Registration No. 333-236351) (the "Registration Statement"), filed on February 10, 2020, and were issued pursuant to an indenture, dated as of May 22, 2014 (the "Indenture"), between the Company and The Bank of New York Mellon Trust Company, N.A., as trustee, and an officer’s certificate, dated as of August 9, 2021 (the "Officer’s Certificate"), setting forth the terms of the Notes. Net proceeds to the Company from the offering were approximately $4,942,167,000, after deducting underwriters’ discounts and estimated offering expenses payable by the Company.

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The relevant terms of the Notes are set forth in the Indenture, included as Exhibit 4.1 of the Company’s Current Report on Form 8-K, filed on May 22, 2014, and incorporated herein by reference, and the Officer’s Certificate (including the forms of the Notes) attached hereto as Exhibit 4.2 and incorporated herein by reference.

The 2028 Notes will pay interest at the rate of 1.650% per annum, the 2032 Notes will pay interest at the rate of 2.000% per annum, the 2041 Notes will pay interest at the rate of 2.800% per annum and the 2052 Notes will pay interest at the rate of 3.000% per annum, which, in the case of the 2028 notes and the 2041 notes, shall be payable in cash semi-annually in arrears on February 15 and August 15 of each year, beginning on February 15, 2022, and in the case of the 2032 notes and the 2052 notes, shall be payable in cash semi-annually in arrears on January 15 and August 15 of each year, beginning on January 15, 2022. The 2028 Notes will mature on August 15, 2028, the 2032 Notes will mature on January 15, 2032, the 2041 Notes will mature on August 15, 2041 and the 2052 Notes will mature on January 15, 2052.

In the event of a change in control triggering event, as defined in the Officer’s Certificate, the holders of the Notes may require the Company to purchase for cash all or a portion of their Notes at a purchase price equal to 101% of the principal amount of Notes, plus accrued and unpaid interest, if any. The descriptions of the Indenture, the Officer’s Certificate and the Notes in this report are summaries and are qualified in their entirety by the terms of the Indenture, the Officer’s Certificate and the Notes, respectively.

The Notes will rank equal in right of payment to all of the Company’s other existing and future senior unsecured indebtedness, senior in right of payment to all of the Company’s existing and future subordinated indebtedness, effectively subordinated in right of payment to all of the Company’s subsidiaries’ obligations (including secured and unsecured obligations) and subordinated in right of payment to the Company’s secured obligations, to the extent of the assets securing such obligations.

On August 9, 2021 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), an innovative commercial-stage biopharmaceutical company, reported financial results for the second quarter of 2021, along with recent product highlights and corporate updates (Press release, Zai Laboratory, AUG 9, 2021, View Source [SID1234586117]).

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"Consistent with our past track record, Zai Lab continued to execute with speed and quality across the organization during the second quarter," said Dr. Samantha Du, Founder, Chairperson and Chief Executive Officer of Zai Lab. "We successfully launched QINLOCK, the first product in what we hope will become a world-class gastric cancer franchise, in China; generated strong revenue growth from ZEJULA and Optune; and entered into strategic collaborations with Mirati, MacroGenics and Schrödinger to further strengthen our disease strongholds in oncology and our global pipeline.

"We anticipate achieving multiple regulatory milestones across our product pipeline throughout 2021, including the potential approval of NUZYRA for community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) by the NMPA. We also continue to make progress in numerous regulatory activities, and we anticipate a discussion with the NMPA in the near future on the filing strategy for efgartigimod. In addition, we anticipate many important data readouts and updates in the remainder of this year, including for Tumor Treating Fields in ovarian cancer, for QINLOCK in second-line GIST, for margetuximab in gastric cancer, for CLN-081 in non-small cell lung cancer (NSCLC), for TPX-0022 in NSCLC and gastric cancer, for adagrasib in NSCLC and colorectal cancer, and for other product candidates in our global pipeline.

"We are focused more than ever on our mission to build a leading global biopharmaceutical company addressing the unmet medical needs of patients in China and around the world," Dr. Du concluded.

Recent Product Highlights and Anticipated Milestones

Oncology

ZEJULA (niraparib)

ZEJULA is an oral, once-daily small-molecule poly ADP-ribose polymerase (PARP) 1/2 inhibitor. It is the only once-daily PARP inhibitor approved in the United States, the European Union and mainland China (hereinafter, "China") as a monotherapy maintenance treatment for patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy, regardless of their biomarker status.

Recent Product Highlight

Zai Lab has made significant progress in recent months in the number of hospitals that list ZEJULA as an approved medicine. From the date of National Reimbursement Drug List (NRDL) implementation on March 1, 2021 to June 30, 2021, the number of hospitals listing ZEJULA has increased sevenfold to more than 800.
Anticipated 2021 Zai Milestones

Complete enrollment of the Phase 1b study of ZEJULA in combination with tebotelimab in gastric cancer.

Announce topline results of the Phase 3 PRIME study of ZEJULA in Chinese patients with first-line ovarian cancer.

Seek NRDL inclusion for a first-line ovarian cancer indication.

Continue to explore additional indications and combination opportunities.
Tumor Treating Fields

Tumor Treating Fields (TTFields) are electric fields tuned to specific frequencies to disrupt cell division.

Recent Product Highlights

In July 2021, Zai Lab partner Novocure announced the final results from its Phase 2 pilot HEPANOVA trial in liver cancer testing the safety and efficacy of TTFields together with sorafenib for the treatment of advanced hepatocellular cancer. In 21 evaluable patients, HEPANOVA showed a 76% disease control rate , 9.5% objective response rate and 5.8 months of progression free survival in a patient population with poor prognosis and limited exposure to study treatments. In patients who completed at least 12 weeks (n=11) of TTFields treatment, the disease control rate was 91% with an 18% objective response rate. Novocure is actively designing a Phase 3 pivotal trial that contemplates TTFields together with the current standard of care, including immunotherapy.

In May 2021, Zai Lab partner Novocure announced that the U.S. Food and Drug Administration (FDA) approved the Investigational Device Exemption (IDE) supplement incorporating the independent data monitoring committee’s recommended protocol changes for its Phase 3 pivotal LUNAR trial in NSCLC, reducing the enrollment requirement to 276 patients with 12 months follow-up following the enrollment of the last patient. Novocure now anticipates last patient enrollment in the LUNAR trial in the fourth quarter of 2021, with final data available in 2022.

In April 2021, 26 presentations on TTFields at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021 suggested the broad applicability of TTFields.

In April and May 2021, Zai Lab initiated the pivotal Phase 3 LUNAR trial in NSCLC and the pivotal Phase 3 METIS trial in brain metastases from NSCLC, respectively, in Greater China.

Zai Lab held extensive campaigns for Optune in Standardized Multi-Department Treatment programs in hospitals.

Optune has been listed in 14 regional customized commercial health insurance plans offered by provincial or municipal governments (or "supplemental insurance plans") since its commercial launch in China in the third quarter of 2020.
Anticipated 2021 Zai Milestones

Submit a Marketing Authorization Application (MAA) for malignant pleural mesothelioma.

Join the global Phase 3 pivotal PANOVA-3 trial for TTFields in locally advanced pancreatic cancer and the Phase 3 pivotal INNOVATE-3 trial for TTFields in recurrent ovarian cancer.

Complete enrollment of the Phase 2 pilot trial in first-line gastric adenocarcinoma.
Anticipated 2021 Partner Milestone

Complete the interim analysis of the Phase 3 pivotal INNOVATE-3 trial for TTFields in recurrent ovarian cancer.
QINLOCK (ripretinib)

QINLOCK is a switch-control tyrosine kinase inhibitor engineered to broadly inhibit KIT- and PDGFRα-mutated kinases. It is the only therapeutic approved in the United States and China for advanced gastrointestinal stromal tumors (GIST) patients who have received prior treatment with three or more kinase inhibitors in the all-comer setting.

Recent Product Highlights

In July 2021, QINLOCK was included in the Chinese Society of Clinical Oncology (CSCO) Guidelines for Diagnosis and Treatment of Gastrointestinal Stromal Tumors 2021 for second-line treatments for advanced GIST patients.

In June 2021, Deciphera presented the intra-patient dose escalation data from the INVICTUS Phase 3 study of QINLOCK in GIST patients. The exploratory analysis showed that dose escalation to QINLOCK 150 mg BID after disease progression on QINLOCK 150 mg QD may be able to offer substantial additional clinical benefit with a tolerable safety profile.

In May 2021, Zai Lab launched QINLOCK in China, our third innovative oncology product launch in China in the last 16 months. Zai Lab has held multiple national launch events for QINLOCK across China since its approval. QINLOCK is listed in two supplemental insurance plans.

Anticipated 2021 Partner Milestones

Obtain topline data from the INTRIGUE Phase 3 study of QINLOCK in patients with second-line GIST in the fourth quarter.

Initiate a Phase 1b/2 study in combination with the MEK inhibitor binimetinib in imatinib-refractory or -intolerant GIST patients.
Adagrasib

Adagrasib is a highly selective and potent oral small-molecule inhibitor of KRASG12C for treating KRAS-G12C-mutated NSCLC, colorectal cancer (CRC), pancreatic cancer and other solid tumors.

Recent Product Highlight

In June 2021, Zai Lab partner Mirati announced that the FDA granted Breakthrough Therapy Designation to adagrasib for the potential treatment of NSCLC patients who harbor the KRASG12C mutation following prior systemic therapy.
Anticipated 2021 Partner Milestones

Mirati plans to present updated NSCLC data in the second half of 2021 and submit an NDA in the United States for adagrasib in the fourth quarter of 2021 for the potential treatment of patients with NSCLC who harbor the KRASG12C mutation following prior systemic therapy.

Mirati plans to present new CRC data from the Phase 1/2 KRYSTAL-01 study evaluating adagrasib in combination with cetuximab (ERBITUX) in second-line patients with a KRASG12C mutation and as a monotherapy in patients who have received three or more lines of therapy.
Odronextamab

Odronextamab is a bispecific monoclonal antibody designed to trigger tumor killing by linking and activating a cytotoxic T-cell (binding to CD3) to a lymphoma cell (binding to CD20).

Recent Product Highlight

In May 2021, Zai Lab partner Regeneron resumed the enrollment of patients with follicular lymphoma and diffuse large B-cell lymphoma in the potentially pivotal Phase 2 program.
Anticipated 2021 Zai Milestone

Enroll the first patient in Greater China in the global, potentially pivotal Phase 2 program.
Anticipated 2021 Partner Milestone

Initiate development of a subcutaneous formulation.
Repotrectinib

Repotrectinib is a next-generation tyrosine kinase inhibitor (TKI) designed to effectively target ROS1 and TRK A/B/C, with the potential to treat TKI-naïve or TKI-pretreated patients.

Recent Product Highlight

In May 2021, Zai Lab enrolled the first patient in Greater China in the global registrational Phase 2 TRIDENT-1 study for both the ROS1+ advanced NSCLC and the NTRK+ advanced solid tumor cohorts.
Anticipated 2021 Partner Milestones

Reach enrollment of 50 patients from both the Phase 1 and Phase 2 portions of the TRIDENT-1 study in the ROS1-positive TKI-naïve NSCLC patient cohort. Zai Lab partner Turning Point Therapeutics has announced that they anticipate an FDA meeting during the first quarter of 2022 to discuss topline blinded independent central review (BICR) results for that cohort.

Initiate TRIDENT-2, a Phase 1b/2 combination study in KRAS-mutant solid tumors.
Provide a clinical data update from the ongoing TRIDENT-1 study.

Report initial clinical data from the Phase 1/2 CARE study in pediatric and young adult patients.
MARGENZA (Margetuximab)

MARGENZA is an Fc-optimized monoclonal antibody that targets the human epidermal growth factor receptor 2 (HER2).

Anticipated 2021 Zai Milestone

Submit an NDA for pretreated metastatic HER2-positive breast cancer around year-end.
Anticipated 2021 Partner Milestones

Obtain initial data from Module A of the MAHOGANY study in the third quarter.

Complete the final overall survival analysis of the SOPHIA study, a randomized, open-label Phase 3 study evaluating margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in patients with HER2-positive metastatic breast cancer who have previously been treated with HER2-targeted therapies, in the third quarter.
Bemarituzumab

Bemarituzumab is a first-in-class antibody that is being developed in gastric and gastroesophageal junction cancer as a targeted therapy for tumors that overexpress FGFR2b.

Recent Product Highlight

In April 2021, Zai Lab partner Amgen was granted Breakthrough Therapy Designation by the FDA for bemarituzumab as first-line treatment for patients with FGFR2b overexpression in HER2-negative metastatic and locally advanced gastric and gastroesophageal adenocarcinoma in combination with modified FOLFOX6 (fluoropyrimidine, leucovorin, and oxaliplatin).
Anticipated 2021 Partner Milestone

Initiate a registrational Phase 3 study in gastric cancer in the fourth quarter.

Plan for clinical development in other FGFR2b+ solid tumors, including squamous cell NSCLC.
CLN-081

CLN-081 is an orally available, small-molecule, next-generation, irreversible epidermal growth factor receptor (EGFR) inhibitor designed to selectively target cells expressing mutant EGFR variants, including EGFR exon 20 insertions.

Recent Product Highlight

In June 2021, Zai Lab partner Cullinan announced Phase 1/2a interim data of CLN-081 in NSCLC EGFR exon 20 patients. CLN-081 continued to demonstrate acceptable overall safety and tolerability, with an encouraging GI toxicity profile.
Anticipated 2021 Partner Milestone

Initiate a potentially registrational Phase 2b clinical trial.
TPX-0022

TPX-0022 is an orally bioavailable, multi-targeted kinase inhibitor with a novel three-dimensional macrocyclic structure that inhibits the MET, CSF1R (colony stimulating factor 1 receptor) and SRC kinases.

Recent Product Highlight

In August and June 2021, Zai Lab partner Turning Point Therapeutics was granted Fast Track Designation and Orphan Drug Designation, respectively, by the FDA for TPX-0022 in gastric cancer.
Anticipated 2021 Partner Milestones

Provide a clinical data update from the dose-finding portion of the Phase 1 SHIELD-1 study and initiate the Phase 2 portion of the SHIELD-1 study, pending FDA feedback.

Initiate SHIELD-2, a Phase 1b/2 combination study with an epidermal growth factor receptor- (EGFR-) targeted therapy.
Tebotelimab

Tebotelimab is an investigational, first-in-class, bispecific, tetravalent DART molecule targeting PD-1 and LAG-3.

Recent Product Highlight

Zai Lab expanded the Phase 1b/2 study of tebotelimab in combination with ZEJULA into new indications in Greater China. In June and July 2021, Zai Lab enrolled the first patients in the biliary tract cancer and triple negative breast cancer cohorts, respectively.
Anticipated 2021 Zai and Partner Milestone

Provide a clinical update, including future development plans.
Autoimmune Diseases

Efgartigimod

Efgartigimod is an antibody fragment designed to reduce disease-causing immunoglobulin G (IgG) antibodies and block the IgG recycling process. Efgartigimod binds to the neonatal Fc receptor (FcRn), which is widely expressed throughout the body and plays a central role in rescuing IgG antibodies from degradation.

Recent Product Highlights

In July 2021, Zai Lab partner argenx announced plans to develop two new indications for efgartigimod: myositis and bullous pemphigoid.

In June 2021, Zai Lab partner argenx announced that The Lancet Neurology published pivotal trial results from the Phase 3 ADAPT trial of efgartigimod for the treatment of adults with generalized myasthenia gravis (gMG).

To date, five Clinical Trial Applications (CTAs) have been approved by the NMPA.
Anticipated 2021 Zai Milestones

Discuss with the NMPA a potential accelerated regulatory pathway for efgartigimod in gMG.

Continue to explore and advance additional indications in coordination with argenx.
Enroll the first patients in Greater China in the global pivotal Phase 3 trials of the subcutaneous formulation in primary immune thrombocytopenia (ITP) and pemphigus vulgaris (PV).

Expect CTA submissions for additional indications.
Anticipated 2021 Partner Milestones

Potential FDA approval, with a Prescription Drug User Fee Act (PDUFA) target action date of December 17, 2021, and global commercial launch of efgartigimod for the treatment of patients with gMG.

Initiate clinical trials in myositis and bullous pemphigoid.
Infectious Disease

NUZYRA (omadacycline)

NUZYRA is a once-daily oral and intravenous antibiotic for the treatment of adults with CABP and ABSSSI.

Recent Product Highlight

In June 2021, Zai Lab partner Paratek Pharmaceuticals announced the sNDA approval from the FDA of the NUZYRA oral-only dosing regimen for the treatment of CABP.
Anticipated 2021 Zai Milestone

Potential NMPA approval and commercial launch of NUZYRA for the treatment of CABP and ABSSSI.
Sulbactam-Durlobactam (SUL-DUR)

Sulbactam-Durlobactam is a beta-lactam/beta-lactamase inhibitor combination that provides unique activity against Acinetobacter organisms, including carbapenem-resistant strains.

Recent Product Highlight

In July 2021, Zai Lab and its partner Entasis Therapeutics completed patient enrollment in the global registrational Phase 3 ATTACK clinical trial.
Anticipated 2021 Zai and Partner Milestone

Announce the top-line data readout of the global registrational Phase 3 ATTACK clinical trial early in the fourth quarter.
Clinical Programs with Global Rights

ZL-1102 (IL-17 Nanobody)

ZL-1102 is a novel human nanobody targeting IL-17 with high affinity and avidity. Unlike other anti-IL-17 products, ZL-1102 is being developed as a topical treatment for chronic plaque psoriasis (CPP).

Anticipated 2021 Zai Milestone

Announce the top-line data readout of the global Phase 1 study.
ZL-1201 (CD47)

ZL-1201 is a humanized, IgG4 monoclonal antibody, engineered to reduce effector function, that specifically targets CD47. Its therapeutic potential will be assessed in both solid tumors and hematological malignancies and in both monotherapy and combination opportunities.

Anticipated 2021 Zai Milestone

Determine a recommended Phase 2 dose in the ongoing Phase 1 trial.
Simurosertib, ZL-2309 (CDC7)

Simurosertib, or ZL-2309, is a potential first-in-class oral selective inhibitor of CDC7, a protein kinase with key roles in DNA replication and in bypassing DNA damage response.

Anticipated 2021 Zai Milestone

Initiate a Phase 2 proof-of-concept study by year-end.
Business Development Updates

In July 2021, Zai Lab and Schrödinger, Inc., announced a global discovery, development and commercialization collaboration focused on a novel DNA damage repair target in oncology. Schrödinger is a recognized leader in providing physics-based computational software platforms used in drug discovery. The research program will be conducted jointly by the scientific teams of the two companies. Following the selection of a development candidate, Zai Lab will assume primary responsibility for global development, manufacturing and commercialization in the program. This initiative will complement Zai’s existing discovery efforts in the DNA damage response pathway in addition to potential combinations with existing Zai Lab products such as the PARP inhibitor ZEJULA and ZL-2309.

In June 2021, Zai Lab and Mirati announced that the companies entered into a collaboration and license agreement for adagrasib, a small-molecule KRASG12C inhibitor, in Greater China. Under the terms of the agreement, Zai Lab obtains the right to research, develop, manufacture and exclusively commercialize adagrasib in Greater China. Zai Lab will support accelerated enrollment in key global, registration-enabling clinical trials of adagrasib in patients with cancer who have a KRASG12C mutation.

In June 2021, Zai Lab and MacroGenics announced that the companies entered into an exclusive collaboration and license agreement involving up to four immuno-oncology molecules. The first collaboration program covers a lead research molecule that incorporates MacroGenics’ DART platform and binds CD3 and an undisclosed target that is expressed in multiple solid tumors. The second collaboration program covers a target to be designated by MacroGenics. For both molecules, Zai receives commercial rights in Greater China, Japan, and Korea, and MacroGenics receives commercial rights in all other territories. For the lead molecule, Zai Lab receives an option to convert the regional arrangement into a global 50/50 profit share upon reaching a predefined clinical milestone. Zai Lab also obtains exclusive, global licenses from MacroGenics to develop, manufacture and commercialize two additional molecules.
Corporate Updates

Zai Lab plans to host a virtual R&D Day on September 22, 2021, to provide a comprehensive update on our business and expanding pipeline across oncology, autoimmune and infectious diseases. Additional details will be announced at a later date.

Zai Lab continues to strengthen and expand its team. New hires include Danielle Halstrom, Senior Vice President, Global Head of Communications, and Jean Wang, PhD, Senior Vice President, Small Molecule CMC.

As of June 30, 2021, Zai Lab employed 1,600 full-time employees, including 594 and 832 employees engaged in research & development (R&D) and commercial activities, respectively.

We continue to invest in our global organization and facilities. During September, we plan to expand our presence in the United States by opening a clinical development and business facility in Cambridge, MA, to tap into the Boston area biopharmaceutical ecosystem. This facility complements our growing R&D and business center in the San Francisco Bay area.
Second-Quarter 2021 Financial Results

For the three months ended June 30, 2021, net product revenues were $36.9 million, compared to $11.0 million for the same period in 2020. Revenues for the period were comprised of $23.4 million for ZEJULA, compared to $7.5 million for the same period in 2020; $9.5 million for Optune, compared to $3.5 million for the same period in 2020; and $4.0 million for QINLOCK, compared to nil for the same period in 2020.

R&D expenses were $142.2 million for the three months ended June 30, 2021, compared to $68.3 million for the same period in 2020. The increase in R&D expenses was primarily attributable to a $65 million upfront payment to Mirati and a $25 million upfront payment to MacroGenics; expenses related to ongoing and newly initiated late-stage clinical trials; and payroll and payroll-related expenses from increased R&D headcount.

Selling, General and Administrative expenses (SG&A) were $54.4 million for three months ended June 30, 2021, compared to $23.8 million for the same period in 2020. The increase was primarily due to payroll and payroll-related expenses from increased commercial headcount and expanded commercial activities in China.

For the three months ended June 30, 2021, Zai Lab reported a net loss of $163.3 million, or a loss per share attributable to common stockholders of $1.76, compared to a net loss of $80.6 million, or a loss per share attributable to common stockholders of $1.08, for the same period in 2020. The increase in the net loss was primarily attributable to payments related to new business development activities with Mirati and MacroGenics recorded in R&D expenses.
As of June 30, 2021, cash and cash equivalents, short-term investments and restricted cash totaled $1,767.3 million compared to $1,187.5 million as of December 31, 2020.
Conference Call and Webcast Information

Zai Lab will host a live conference call and webcast today, August 10, 2021, at 8:00 a.m. EDT. Listeners can access the live webcast by visiting the Company’s website at View Source Participants must register in advance of the conference call. Details are as follows:

Registration Link: View Source

Conference ID: 7290113
All participants must use the link provided above to complete the online registration process in advance of the conference call. Upon registering, each participant will receive a dial-in number, Direct Event passcode and a unique access PIN, which can be used to join the conference call.

A replay will be available shortly after the call and can be accessed by visiting the Company’s website at View Source

On August 9, 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 cancer and autoimmune diseases, reported financial results for the second quarter 2021, recent business highlights and key catalysts over the next several months (Press release, Atara Biotherapeutics, AUG 9, 2021, View Source [SID1234586116]).

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"We are very pleased with the progress achieved across all of our programs and important clinical updates across our full pipeline, which will enable us to deliver on key value drivers through the rest of this year and into 2022," said Pascal Touchon, President and Chief Executive Officer of Atara. "Recent tab-cel regulatory progress and alignment with both FDA and EMA allow us to continue anticipating approvals in 2022, while exciting new ATA188 imaging data reinforces our belief in this potentially transformative therapy for patients with multiple sclerosis."

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

Atara conducted productive meetings with the U.S. Food and Drug Administration (FDA), gaining clarity on specific next steps required for submission of the Biologics License Application (BLA)
Alignment on key methodologies for evaluating comparability between Atara product used in the pivotal ALLELE study and the intended commercial product. Atara will provide data on substantially all lots made to date through a Type B CMC meeting to enable FDA to make a final determination on the data package to support comparability
FDA decided it cannot make a determination of comparability between material used in non-pivotal and pivotal studies because analytical data is not available and cannot be generated for all lots manufactured at Memorial Sloan Kettering Cancer Center (MSK) and used in non-pivotal studies. Consequently, Atara plans to submit clinical data from the pivotal ALLELE study and the non-pivotal studies as separate, non-pooled analyses in the anticipated BLA submission
FDA has not requested additional assays or manufacturing lots
Atara completed a new data analysis from its Phase 3 ALLELE study, as previously discussed with FDA. Top-line data with additional patients confirm a strong objective response rate (ORR) in line with prior results while demonstrating durability. There were no new safety signals, consistent with previously published findings
These data will be discussed with the FDA through a Type B meeting and are planned to be presented at an appropriate congress in Q4 2021
Based on the outcome of the recent and anticipated interactions with the FDA, Atara expects to complete the BLA submission for tab-cel in Q1 2022. Atara is adapting investment in U.S. commercial readiness toward anticipated approval in H2 2022
Following recent successful Rapporteur/Co-Rapporteur and pre-submission meetings with the European Medicines Agency (EMA), Atara has completed the necessary regulatory and compliance steps needed to submit an EU Marketing Authorization Application (MAA) for tab-cel in patients with EBV+ PTLD, which is on track for November 2021. The Company anticipates a decision regarding approval in H2 2022
Discussions with potential partners for the commercialization of tab-cel in Europe are advancing well and are in line with our expectation to secure a partner by Q4 2021
Atara presented data at the American Transplant Congress (ATC) in June 2021 from a combined long-term overall survival (OS) analysis from three clinical studies of tab-cel demonstrating that patients with EBV+ PTLD following solid organ transplant (SOT) that is relapsed or refractory to initial treatment, derived similar OS benefit of greater than 80 percent at two years whether they achieved complete or partial response with tab-cel
Tab-cel for Potential Additional Indications

Atara continues to pursue development of tab-cel in additional patient populations with an initial focus on immunodeficiency-associated lymphoproliferative diseases (IA-LPDs), given the commonality of their EBV-driven mechanism of disease in immunocompromised patients, high unmet medical need, and positive clinical data to date with tab-cel
Actively enrolling at sites in the Phase 2 multi-cohort study, which is evaluating six patient populations, including four within IA-PLDs and two in other EBV-driven diseases, in the U.S. and EU
Atara joined the Rare Disease Company Coalition, an alliance of innovative life sciences companies engaging policymakers on the unique needs of the rare disease community, the urgency of and support for innovation to address significant unmet patient need and dialogue around policies that advocate for timely and appropriate access to safe and transformational treatments, including tab-cel
ATA188 for Progressive Forms of Multiple Sclerosis (PMS)

Long-term, two-year clinical data from the Phase 1 open-label extension (OLE) and translational data from the Phase 1 study of ATA188 in PMS has been accepted for presentation at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in October
The presentation, titled "Updated open-label extension clinical data and new magnetization transfer ratio imaging data from a Phase I study of ATA188, an off-the-shelf, allogeneic Epstein-Barr virus-targeted T-cell immunotherapy for progressive multiple sclerosis" will feature updated clinical and new imaging biomarker data considered to reflect the state of myelination in the central nervous system, known as magnetization transfer ratio (MTR)
MTR may provide important insights into the mechanism of expanded disability status scale (EDSS) improvement in our clinical assessment of ATA188
Atara is making progress on enrolling the ATA188 Phase 2 randomized, double-blind, placebo-controlled trial (EMBOLD study) evaluating the efficacy and safety of ATA188 in patients with PMS
Planned interim analysis in H1 2022 to assess efficacy and safety
Based on current target, Atara expects to complete enrollment in H1 2022
The Company will present a poster on PMS fatigue and an oral presentation on the ongoing EMBOLD study at the upcoming 2021 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC) in October
There is growing awareness of the transformative potential of ATA188 in MS among neurologists
CAR T Programs

ATA2271/ATA3271 (Solid Tumors Over-Expressing Mesothelin)

The global strategic collaboration for ATA2271 and ATA3271 with Bayer continues to progress well with advancement of the mesothelin-partnered CAR T immunotherapy programs
The Company anticipates presentation of the first update on clinical data from the open-label, single-arm Phase 1 clinical study of ATA2271, an autologous CAR T therapy targeting mesothelin, designed to improve efficacy, persistence, and durability of response for patients with advanced mesothelioma, in an appropriate forum in Q4 2021. Enrollment has been completed for the first cohort and is nearly complete for the second cohort of this study
Atara is continuing to make progress on IND-enabling studies for ATA3271, an off-the-shelf, allogeneic CAR T therapy targeting mesothelin using next-generation PD-1 dominant negative receptor (DNR) and 1XX CAR co-stimulatory signaling domain technologies and expects an IND filing in H2 2022
The Company plans to present preclinical data for ATA3271 at an appropriate forum in Q4 2021
ATA3219 (B-cell Malignancies)

Atara expects to submit an IND for ATA3219, an off-the-shelf, allogeneic CD19 CAR T immunotherapy targeting B-cell malignancies, as a potential best-in-class therapy without the need for T-cell receptor (TCR) gene editing, using our next-generation 1XX CAR co-stimulatory signaling domain and EBV T-cell platform in Q1 2022
Executive and Board Appointments

Cell therapy and oncology expert, Cokey Nguyen, Ph.D., recently joined Atara as Chief Scientific Officer to further our mission of developing transformative therapies for patients with severe diseases. Dr. Nguyen joined Atara from Fate Therapeutics, where, as Vice President, Innovation, Research and Development, he directed strategy for discovery and innovation efforts, and spearheaded the corporate collaboration program with ONO Pharma
Cell therapy and oncology commercialization veteran, Ameet Mallik, was appointed to the Board of Directors. Mr. Mallik is CEO of Rafael Holdings, a late-stage cancer metabolism therapeutic company and has held several leadership roles at Novartis, most recently as EVP & Head of U.S. Oncology. He brings to Atara’s Board a wealth of experience with U.S. payer, access and reimbursement strategies and launches of innovative oncology therapies, including CAR T
Second Quarter 2021 Financial Results

Cash, cash equivalents and short-term investments as of June 30, 2021 totaled $373.4 million, as compared to $435.2 million as of March 31, 2021
Atara believes that its cash as of June 30, 2021 is sufficient to fund planned operations into 2023
License and collaboration revenue was $3.9 million for the second quarter 2021 and consisted of revenue from activities performed under the Bayer Collaboration Agreements. Atara did not recognize any license and collaboration revenue for the same period in 2020
Net cash used in operating activities was $61.6 million for the second quarter 2021, as compared to $56.6 million for the same period in 2020
Atara reported net losses of $83.8 million, or $0.91 per share, for the second quarter 2021, as compared to $77.5 million, or $1.14 per share, for the same period in 2020
Total operating expenses include non-cash expenses of $16.1 million for the second quarter 2021, as compared to $15.9 million for the same period in 2020
Research and development expenses were $68.5 million for the second quarter 2021, as compared to $61.6 million for the same period in 2020
The increase in the second quarter 2021 was primarily due to higher employee-related costs from increased headcount, increased spending on the Company’s ATA188 and CAR T programs and increased facilities and information technology expenses allocated to research and development
Research and development expenses include $8.3 million of non-cash stock-based compensation expenses for the second quarter 2021, as compared to $8.5 million for the same period in 2020
General and administrative expenses were $19.4 million for the second quarter 2021, as compared to $16.4 million for the same period in 2020
General and administrative expenses include $5.5 million of non-cash stock-based compensation expenses for the second quarter 2021, as compared to $5.4 million for the same period in 2020
Conference Call and Webcast Details

Atara will host a live conference call and webcast today, Monday, August 9, 2021, at 4:30 p.m. EDT to discuss the Company’s financial results and recent operational highlights. Analysts and investors can participate in the conference call by dialing 877-407-8291 for domestic callers and 201-689-8345 for international callers, using the conference ID 13720150. A live audio webcast can be accessed by visiting the Investors & Media – News & Events section of atarabio.com. An archived replay will be available on the Company’s website for 30 days.

On August 9, 2021 FibroGen, Inc. (NASDAQ: FGEN) reported financial results for the second quarter 2021 and provided an update on the Company’s recent developments (Press release, FibroGen, AUG 9, 2021, View Source [SID1234586115]).

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"We continue to be energized by the performance of roxadustat in China, where we are seeing impressive adoption of roxadustat in a rapidly expanding anemia of CKD market. In addition, the positive CHMP opinion in Europe brings roxadustat one step closer to patients in this important region," said Enrique Conterno, Chief Executive Officer, FibroGen. "We look forward to the European Commission decision following the positive CHMP opinion. On the other hand, we are disappointed with the FDA Cardiovascular and Renal Drugs Advisory Committee negative vote, and we will continue to work with our partner AstraZeneca and the FDA on a path forward."

Recent Key Events and Other Developments

Regulatory:

In June, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion relating to the use of roxadustat for the treatment of adult patients with symptomatic anemia associated with chronic kidney disease (CKD). A European Commission decision is expected in August 2021.
In July, the U.S. Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted to recommend not approving roxadustat for the treatment of anemia due to CKD. An FDA action on the new drug application is expected in the near future.
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1 Total roxadustat net sales in China includes sales made by the distribution entity as well as FibroGen China’s direct sales, each to its own distributors. The distribution entity jointly owned by AstraZeneca and FibroGen is not consolidated into FibroGen’s financial statements.

Clinical:

Pamrevlumab included in the Pancreatic Cancer Action Network’s (PanCAN) Precision PromiseSM adaptive trial platform evaluating pamrevlumab for patients with metastatic pancreatic cancer.
China:

Roxadustat net product revenue in China of $13.4 million, on a US GAAP basis, including revenue generated from our sales to the distribution entity and FibroGen China’s direct sales, compared to $15.4 million last quarter.
Total roxadustat net sales in China of $52.8 million by FibroGen and the distribution entity jointly owned by FibroGen and AstraZeneca, compared to $43.5 million last quarter.
Hospital listings at the end of the second quarter represented approximately 81% of the CKD anemia market opportunity in China versus 74% last quarter.
Clinical Presentations / Publications:

FibroGen and its partners presented three roxadustat oral presentations and ten mini-oral presentations at the recent 58th European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Virtual Congress.
Two additional roxadustat Phase 3 manuscripts on the treatment of anemia of CKD were published in a peer-reviewed medical journal, bringing the total to 7:
Roxadustat for the treatment of anaemia in chronic kidney disease patients not on dialysis: a phase 3, randomised, open-label, active-controlled study (DOLOMITES) Nephrology Dialysis Transplantation.
Efficacy and Cardiovascular Safety of Roxadustat for Treatment of Anemia in Patients with Non–Dialysis-Dependent CKD (NDD Pooled) Clinical Journal of the American Society of Nephrology.
FibroGen presented one oral presentation and one poster presentation of two-year data from a Phase 2 trial of pamrevlumab in non-ambulatory DMD patients at the recent Parent Project Muscular Dystrophy (PPMD) Annual Conference.
Upcoming Data Milestones:

Data from the Phase 2 WHITNEY study of roxadustat in chemotherapy-induced anemia (CIA) expected 3Q 2021 versus prior 2H 2021.
Topline data from the Phase 3 MATTERHORN study of roxadustat in anemia of myelodysplastic syndromes (MDS) now expected 2H 2022 / 1H 2023 versus prior 1H 2022.
Interim analysis of event free survival for potential accelerated approval of Phase 3 LAPIS study of pamrevlumab in locally advanced pancreatic cancer (LAPC) will be completed in 2H 2022.
Topline data from the Phase 3 LELANTOS-1 study of pamrevlumab in Duchenne muscular dystrophy (DMD) now expected 1H 2023 versus prior 2H 2022.
Topline data from the Phase 3 ZEPHYRUS-1 study of pamrevlumab in idiopathic pulmonary fibrosis (IPF) expected mid-2023.
Corporate

Appointed John Hunter, Ph.D. as Chief Scientific Officer.
FibroGen and HiFiBiO announced partnership to advance next-generation therapies for patients with cancer and autoimmune disease. FibroGen exclusively licensed HiFiBiO’s Galectin-9 program, and obtained an exclusive option to their CXCR5 and CCR8 programs.
Eluminex Biosciences exclusively licensed worldwide rights to develop and commercialize FibroGen’s investigational biosynthetic cornea program and the underlying recombinant human collagen Type III technology.
The Company has completed its internal review of the events leading to our April 6, 2021 disclosures in which we clarified that certain cardiovascular safety analyses from the roxadustat Phase 3 program for the treatment of anemia of chronic kidney disease included post-hoc changes to the stratification factors.
Financial:

Total revenue for the second quarter of 2021 was $24.4 million, as compared to $42.9 million for the second quarter of 2020. The current quarter revenue includes $13.4 million net product revenue for roxadustat sales in China, and $19.6 million in development revenue. The current quarter also includes $(8.6) million drug product revenue as a result of the recent unfavorable CRDAC vote.
Operating costs and expenses for the second quarter of 2021 included a one-time charge of $25 million related to our partnership with HiFiBio, and an increase of approximately $20 million driven primarily by pamrevlumab development expenses compared to one year ago.
Net loss for the second quarter of 2021 was $134.0 million, or $1.45 net loss per basic and diluted share, compared to a net loss of $85.3 million, or $0.95 net loss per basic and diluted share one year ago.
Conference Call and Webcast Details
FibroGen will host a conference call and webcast today, Monday, August 9, 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 second quarter 2021 financial results conference call, and use confirmation number 4951789. 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 4951789.

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, Chile, and South Korea for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). In Europe, the Marketing Authorisation Application is under review by the European Medicines Agency (EMA). In the U.S., the New Drug Application is under review by the U.S. Food and Drug Administration. 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.