On August 8, 2019 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported recent business highlights, anticipated upcoming milestones, and financial results for the second quarter and first half of 2019 (Press release, BeiGene, AUG 8, 2019, View Source [SID1234538413]).

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"This quarter, our team continued to deliver across all functions, with the completion of enrollment in five Phase 3 or pivotal trials and the initiation of three new Phase 3 trials in oncology indications where we expect to have a profound impact on people fighting both hematologic and solid tumors. We believe that we are well-positioned to continue running our late-stage trials, including those for tislelizumab, for which we re-acquired full global rights from Celgene in advance of the closing of its pending acquisition by Bristol-Myers Squibb," said John V. Oyler, Co-Founder, Chief Executive Officer, and Chairman of BeiGene. "We are progressing well with our U.S. and China product launch preparations, including our commercial and manufacturing build-outs, and we expect the remainder of 2019 and 2020 to be transformative for BeiGene, with readouts from up to 10 ongoing Phase 3 or potentially registration-enabling studies in addition to planned commercial launches of two of our internally developed products."
Recent Business Highlights and Upcoming Milestones
Clinical Programs
Zanubrutinib, an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to maximize BTK occupancy and minimize off-target effects

Completed enrollment in the global Phase 3 SEQUOIA trial (NCT03336333) comparing zanubrutinib with bendamustine plus rituximab in patients with treatment-naive (TN) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL);

Achieved first patient dosing in a Phase 1b trial (NCT02914938) conducted by MEI Pharma of zanubrutinib in combination with ME-401, an investigational selective oral phosphatidylinositol 3-kinase (PI3K) delta inhibitor;

Presented data at the 15th International Conference on Malignant Lymphoma (ICML), including:
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Clinical data from the pivotal Phase 2 trial (NCT03206918) in China in patients with relapsed/refractory (R/R) CLL or SLL;
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Updated data from the pivotal Phase 2 trial (NCT03206970) in China in patients with R/R mantle cell lymphoma (MCL);
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Updated data from the global Phase 1/2 trial (NCT02343120) in patients with different subtypes of B-cell malignancies, including MCL;
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Updated data from the Phase 1b combination trial (NCT02569476) with GAZYVA (obinutuzumab) in patients with R/R or TN CLL or SLL, and patients with R/R follicular lymphoma (FL).

Presented data at the 24th Congress of European Hematology Association (EHA) (Free EHA Whitepaper), including:
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Clinical data from the nonrandomized cohort in patients with MYD88wt Waldenström’s Macroglobulinemia (WM) from the Phase 3 ASPEN trial (NCT03053440). The randomized cohort of the study, in patients with MYD88mut WM, is ongoing;
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Updated results from the ongoing Phase 1 trial (NCT02343120) of patients with WM;
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Pooled safety data from six ongoing monotherapy studies in patients with B-cell malignancies; and

Published in Blood, the Journal of the American Society of Hematology (ASH) (Free ASH Whitepaper), an article on the Phase 1 trial of zanubrutinib in R/R B-cell malignancies, including CLL/SLL.
Expected Milestones for Zanubrutinib

Receive approvals in China for the treatment of patients with R/R MCL and R/R CLL/SLL in the first half of 2020. The Company expects manufacturing inspections to occur after the completion of the technical reviews. In addition, non-clinical and chemistry, manufacturing and controls (CMC) supplemental information was requested and has been provided;

File an initial New Drug Application (NDA) in the U.S. in 2019 or early 2020;

File a supplemental new drug application (sNDA) in China for WM in 2019;

Announce top-line results from the Phase 3 ASPEN trial comparing zanubrutinib to ibrutinib in patients with WM in 2019;

Announce top-line interim analysis from the SEQUOIA trial comparing zanubrutinib with bendamustine plus rituximab in patients with TN CLL or SLL as early as 2020; and

Initiate a global Phase 3 clinical trial (NCT04002297) comparing zanubrutinib plus rituximab versus bendamustine plus rituximab in patients with previously untreated MCL who are ineligible for stem cell transplant in 2019.
Tislelizumab, an investigational humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages

Filed an sNDA in China for patients with previously treated locally-advanced or metastatic urothelial carcinoma (UC); the sNDA has been granted priority review status from the China National Medical Products Administration (NMPA);

Regained full global rights from Celgene in advance of its pending acquisition by Bristol-Myers Squibb, and received a payment of $150 million in connection with the termination;

Completed enrollment in the Phase 3 trials in China of tislelizumab combined with chemotherapy in the front-line setting for patients with advanced squamous (NCT03594747) and non-squamous (NCT03663205) non-small cell lung cancer (NSCLC);

Initiated the following trials:
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A Phase 3 randomized trial (NCT04005716) in China of platinum plus etoposide with or without tislelizumab in patients with untreated extensive-stage small cell lung cancer (SCLC);
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A Phase 3 randomized trial (NCT03967977) in China of tislelizumab in combination with chemotherapy versus chemotherapy alone in patients with previously untreated locally advanced or metastatic UC; and
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A Phase 3 randomized trial (NCT03957590) in China of tislelizumab versus placebo in combination with chemoradiotherapy in patients with localized esophageal squamous cell carcinoma (ESCC).

Presented updated clinical results from the pivotal Phase 2 trial (NCT03209973) in China in patients with R/R classical Hodgkin lymphoma (cHL) at EHA (Free EHA Whitepaper); and

Presented preliminary Phase 2 results from the Phase 1/2 trial (NCT03924986) in China in patients with nasopharyngeal cancer (NPC) at ASCO (Free ASCO Whitepaper).
Expected Milestones for Tislelizumab

Receive NDA approval in China for treatment of patients with R/R cHL in 2019;

Announce top-line results from the global Phase 2 trial (NCT03419897) in second- or third-line patients with hepatocellular carcinoma (HCC) in 2019 or early 2020 and have regulatory discussions;

Announce top-line results from the Phase 3 trial (NCT03594747) in first-line squamous NSCLC in China in 2019 or 2020;

Announce top-line results from the Phase 3 trial (NCT03663205) in first-line non-squamous NSCLC in China in 2020; and

Complete enrollment in the global first-line Phase 3 trial (NCT03412773) in HCC in 2019 and the global portion of the second-line Phase 3 trial (NCT03358875) in NSCLC in 2019 or early 2020.
Pamiparib, an investigational small molecule PARP inhibitor

Completed enrollment in the Phase 3 randomized trial in China (NCT03519230) of pamiparib versus placebo as a potential maintenance treatment in patients with platinum-sensitive recurrent ovarian cancer;

Completed enrollment in the pivotal Phase 2 trial in China (NCT03333915) in third-line and above patients with ovarian cancer with germ-line BRCA mutation; and

Published in The Lancet Oncology an article on the Phase 1A/B trial of pamiparib in combination with tislelizumab in patients with advanced solid tumors.
Expected Milestones for Pamiparib

Announce top-line results from the pivotal Phase 2 trial in Chinese patients with previously treated ovarian cancer in 2020; and

Announce top-line results from the Phase 3 trial in China of pamiparib versus placebo as a potential maintenance treatment in patients with platinum-sensitive recurrent ovarian cancer in 2020.
Sitravatinib, an investigational tyrosine kinase inhibitor of receptor tyrosine kinases (RTKs), including TAM family receptors (TYRO3, Axl, MER), split family receptors (VEGFR2, KIT) and RET, licensed from Mirati Therapeutics in Asia (excluding Japan), Australia, and New Zealand

Initiated a Phase 1/2 trial (NCT03941873) in China of sitravatinib in combination with tislelizumab in patients with unresectable locally advanced or metastatic HCC or gastroesophageal junction cancer.
BGB-A1217, an investigational TIGIT monoclonal antibody discovered by BeiGene scientists
Expected Milestones for BGB-A1217

Initiate patient enrollment in a Phase 1a/1b trial in China and Australia investigating the safety, tolerability, pharmacokinetics and preliminary antitumor activity of BGB-A1217 in combination with tislelizumab in patients with advanced solid tumors in 2019.
Manufacturing Facilities

Completed equipment installation and systems qualification of the Company’s biologics manufacturing facility in Guangzhou, China. We expect manufacturing and validation of tislelizumab drug substance to begin later this year.
Commercial Product Portfolio

Generated $58.14 million in product revenue in the three months ended June 30, 2019, from sales in China of ABRAXANE, REVLIMID and VIDAZA, which represents an 85.0% increase compared to the same period in 2018; and

Announced that the China National Medical Products Administration (NMPA, formerly known as CFDA) accepted the supplemental import drug application for ABRAXANE (paclitaxel protein-bound particles for injectable suspension) (albumin-bound), in combination with gemcitabine, as a potential first-line treatment of patients with metastatic adenocarcinoma of the pancreas (mPC).
Corporate Developments

Received approval from the Stock Exchange of Hong Kong Limited (HKEX) to transition into a general listing under Rule 8.05(3) by meeting its specified revenue and market capitalization thresholds. As a result of the approval, the "B" marker was removed from the Company’s stock symbol in the HKEX, and the Company’s ordinary shares may become eligible for listing in the Hang Seng indices;

Along with SpringWorks Therapeutics, announced the formation of MapKure, LLC to develop BGB-3245, an investigational, selective next-generation RAF kinase inhibitor discovered by BeiGene scientists;

Appointed Qingyi "Anita" Wu as Chief Commercial Officer, Greater China. Prior to joining BeiGene, Anita served as General Manager of the Specialty Care business unit at Sanofi China; and

Appointed Yan "Lily" Liu as Vice President, Head of Marketing, Greater China. Lily was most recently Vice President, Head of the Specialty Care business unit at Takeda China.

Second Quarter 2019 Financial Results
Cash, Cash Equivalents, Restricted Cash and Short-Term Investments were $1.56 billion as of June 30, 2019, compared to $1.64 billion as of March 31, 2019 and $1.81 billion as of December 31, 2018.

The decrease of $76.07 million in the second quarter of 2019 was primarily due to $46.10 million of cash used in operating activities, $21.45 million for investments in property, plant and equipment, and $20 million for an upfront payment related to the BioAtla collaboration agreement.
Revenue for the quarter ended June 30, 2019 was $243.35 million, compared to $52.80 million in the same period in 2018. The increase is primarily attributable to the $150 million payment received in connection with the termination of the tislelizumab collaboration agreement with Celgene, the recognition of previously deferred revenue from the collaboration as well as increased product revenue from sales of the in-licensed products from Celgene in China.

Product revenue from sales of ABRAXANE, REVLIMID and VIDAZA in China totaled $58.14 million for the second quarter ended June 30, 2019, compared to $31.43 million for the same period in 2018.

Collaboration revenue totaled $185.20 million for the second quarter ended June 30, 2019, compared to $21.38 million for the same period in 2018. The increase is due primarily to the $150 million payment in connection with the termination of our tislelizumab collaboration agreement with Celgene, as well as the recognition of previously deferred revenue from the collaboration.
Expenses for the second quarter ended June 30, 2016 were $329.18 million, compared to $215.85 million in the same period in 2018.

Cost of sales for the second quarter ended June 30, 2019 were $17.84 million, compared to $6.26 million in the same period in 2018. Cost of sales related to the cost of acquiring ABRAXANE, REVLIMID and VIDAZA for distribution in China.

R&D Expenses for the second quarter ended June 30, 2019 were $228.76 million, compared to $164.25 million in the same period in 2018. The increase in R&D expenses was primarily attributable to increased spending on our ongoing and newly initiated late-stage pivotal clinical trials, preparation for regulatory submissions and commercial launch of our late-stage drug candidates, and manufacturing costs related to pre-commercial activities and supply. Additionally, we expensed $20.0 million for the upfront payment related to the BioAtla collaboration agreement. Employee share-based compensation expense also contributed to the overall increase in R&D expenses, and was $18.15 million for the second quarter ended June 30, 2019, compared to $10.72 million for the same period in 2018, due to increased headcount.

SG&A Expenses for the second quarter ended June 30, 2019 were $82.25 million, compared to $45.16 million in the same period in 2018. The increase in SG&A expenses was primarily attributable to increased headcount, including the expansion of our commercial team to support the distribution of our commercial products in China and the potential launches of our late-stage drug candidates, as well as higher professional service fees and costs to support our growing operations. The overall increase in SG&A expenses was also attributable to higher SG&A-related share-based compensation expense, which was $14.45 million for the second quarter ended June 30, 2019, compared to $7.92 million for the same period in 2018, due to increased headcount.

Net Loss for the second quarter ended June 30, 2019 was $85.57 million, or $0.11 per share, or $1.43 per American Depositary Share (ADS), compared to $156.89 million, or $0.22 per share, or $2.92 per ADS in the same period in 2018.

[1] The bank loan is attributable to BeiGene Biologics, a joint venture that is 95% owned by BeiGene, Ltd., which totaled $84.49 million as of June 30, 2019, and the current portion of long-term debt for a term note secured by our Suzhou manufacturing facility.
[2] The shareholder loan is attributable to a RMB900 million convertible note obtained in 2017 from our joint venture partner for the construction and operation of our manufacturing facilities in Guangzhou.

On August 8, 2019 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, reported financial results for the second quarter of 2019 and recent operational highlights (Press release, Atara Biotherapeutics, AUG 8, 2019, View Source [SID1234538412]).

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"I am confident we are now in a strong position to execute and create value across our tab-cel, multiple sclerosis and next-generation CAR T programs," said Pascal Touchon, President and Chief Executive Officer of Atara Biotherapeutics. "We believe our updated tab-cel development strategy, focusing on initiating an EBV+ PTLD regulatory submission first in the United States, prioritizes the most attractive market for such an ultra-rare disease and advances our mission to bring transformative T-cell immunotherapies to patients in critical need. In addition, we are encouraged by the initial safety results from our ongoing ATA188 Phase 1 study for patients with progressive MS and look forward to presenting the initial efficacy results from this study in September. We also strengthened our financial position, funding planned operations into 2021 and through key milestones next year including initiating the tab-cel BLA submission and next-generation mesothelin CAR T IND."

Recent Highlights and Anticipated Upcoming Milestones

Tab-cel (tabelecleucel)

Atara continues to progress tab-cel Phase 3 development for patients with Epstein-Barr virus associated post-transplant lymphoproliferative disease (EBV+ PTLD).
Based on discussions with the U.S. Food & Drug Administration (FDA), Atara plans to initiate a tab-cel biologics license application (BLA) submission for patients with EBV+ PTLD in the second half of 2020.
In the United States and Australia, 34 sites are available for enrollment and the company is preparing to open additional sites in the United States, Europe and Canada.

We continue to see strong tab-cel investigator, physician and patient interest and, in cases where we are not able to enroll patients in our EBV+ PTLD Phase 3 clinical studies, we are providing tab-cel to patients in need under our early access and single patient use programs.

Atara is in discussions with the European Medicines Agency (EMA) and the outcome of these discussions will determine the timing of the tab-cel EU conditional marketing authorization (CMA) application for patients with EBV+ PTLD.

Studies supporting potential additional tab-cel indications are also advancing.
A Phase 1/2 clinical study of tab-cel in combination with Merck’s anti-PD-1 (programmed death receptor-1) therapy, KEYTRUDA (pembrolizumab), in patients with platinum-resistant or recurrent EBV-associated nasopharyngeal carcinoma (NPC) is currently enrolling.
Atara expects to initiate a Phase 2 multi-cohort study including patients with other EBV+ cancers in the second half of 2020.

ATA188 & ATA190 for Multiple Sclerosis (MS)

A Phase 1 clinical study of off-the-shelf, allogeneic ATA188 in patients with progressive MS is ongoing across clinical sites in the United States and Australia.
Initial ATA188 Phase 1 safety results for patients with progressive MS were presented at the 5th Congress of the European Academy of Neurology (EAN). The first three ATA188 dose cohorts were well tolerated with no dose-limiting toxicities and no ≥3 grade treatment-related, treatment-emergent adverse events.
Atara plans to present initial efficacy and additional safety results from this study at the 35thCongress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) to be held September 11-13 in Stockholm, Sweden.
A randomized, double-blind, placebo-controlled Phase 1b part of this study using the recommended Phase 2 dose (RP2D) is now planned following completion of the open-label, dose-escalation period.

Atara expects to initiate a randomized study of autologous ATA190 in progressive MS patients during the second half of 2019.

Next-Generation CAR T

Positive Phase 1 clinical results for a mesothelin-targeted CAR T immunotherapy in patients with advanced mesothelioma were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2019.
Memorial Sloan Kettering Cancer Center (MSK) collaborators presented results demonstrating that their regionally delivered mesothelin-targeted, autologous CAR T cells were well tolerated and showed encouraging anti-tumor activity in combination with pembrolizumab, a PD-1 checkpoint inhibitor.
In a subset of 16 malignant pleural mesothelioma patients with minimum follow-up time of 3 months who also received pembrolizumab and lymphodepleting chemotherapy, 12-month overall survival was 80% and best overall response rate was 63%, including 3 investigator-assessed complete responses.

Atara prioritized the mesothelin-targeted next-generation CAR T program, with an IND planned for autologous ATA2271 in advanced mesothelioma in 2020.

Corporate

Pascal Touchon was appointed President, Chief Executive Officer and member of the Board of Directors. Prior to joining Atara in June, Dr. Touchon served as Novartis Oncology Global Head, Cell & Gene and member of the Oncology Executive Committee.

Atara completed facility commissioning and qualification activities to support clinical operations at ATOM (Atara T-cell Operations and Manufacturing).
Commercial production qualification activities are nearing completion and, together with our contracted manufacturing partner, are aligned with our planned commercial strategy.

Second Quarter 2019 Financial Results

Cash, cash equivalents and short-term investments as of June 30, 2019 totaled $190.1 million. In July 2019 we sold approximately 6.9 million shares of common stock and pre-funded warrants to purchase approximately 2.9 million shares of common stock for net proceeds of $140.6 million in an underwritten public offering.
The Company believes the net proceeds from the offering, together with existing cash, cash equivalents and short-term investments, are sufficient to fund planned operations into 2021.
The Company reported net losses of $74.3 million, or $1.60 per share, for the second quarter of 2019 as compared to $50.9 million, or $1.15 per share, for the same period in 2018.
Total operating expenses include total non-cash expenses of $16.9 million for the second quarter of 2019 as compared to $8.7 million for the same period in 2018.
Research and development expenses were $52.3 million for the second quarter of 2019 as compared to $33.4 million for the same period in 2018. The increase in the second quarter of 2019 was due to costs associated with the Company’s continuing expansion of research and development activities, including:
° clinical study, manufacturing and outside service costs related to our tab-cel, ATA188 and ATA190 programs, including strategic spending to build inventory for clinical studies and potential commercialization;
° higher employee-related and overhead costs from increased headcount and operations, and
° an increase in facilities and information technology expenses that are attributed to our research and development function.
Research and development expenses include $6.7 million of non-cash stock-based compensation expense for the second quarter of 2019 as compared to $3.4 million for the same period in 2018.
General and administrative expenses were $23.3 million for the second quarter of 2019 as compared to $19.2 million for the same period in 2018. The increase in the second quarter of 2019 was primarily due to increases in professional services costs and employee-related costs driven by increased headcount to support the Company’s expanding operations.
General and administrative expenses include $8.5 million of non-cash stock-based compensation expense for the second quarter of 2019 as compared to $4.6 million for the same period in 2018.
Conference Call and Webcast Information

Atara will host a live conference call and webcast today at 8:00 a.m. EDT to discuss the Company’s financial results and recent operational highlights. Analysts and investors can participate in the conference call by dialing (888) 540-6216 for domestic callers and (734) 385-2715 for international callers, using the conference ID 4179789. A live audio webcast can be accessed by visiting the Investor Events and Presentations section of atarabio.com. An archived replay will be available on the Company’s website for approximately 14 days following the live webcast.

On August 8, 2019 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation, reported operating results for the second quarter ended June 30, 2019 and provided pipeline updates (Press release, AnaptysBio, AUG 8, 2019, View Source [SID1234538411]).

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"In the first half of 2019, we’ve made significant progress across our entire clinical and preclinical pipeline toward achieving our mission of bringing novel treatments to patients with severe inflammatory diseases," said Hamza Suria, president and chief executive officer of AnapytsBio. "With multiple data readouts from our etokimab and ANB019 clinical trials, and an IND planned for ANB030, the remainder of 2019 is set to be an important period for AnaptysBio."

Etokimab (ANB020 Anti-IL-33) Program

In June 2019, AnaptysBio presented full data from its Phase 2a proof-of-concept clinical trial of etokimab in adult patients with severe eosinophilic asthma at the 2019 European Academy of Allergy and Clinical Immunology (EAACI) Congress. Data showed that a single dose of etokimab resulted in rapid and sustained lung function improvement as measured using Forced Expiratory Volume in One Second, or FEV1, patient reported outcomes associated with asthma symptoms, as measured using the Asthma Control Questionnaire 5, and biomarker levels as measured using blood eosinophils. The Company believes these data support continued development of etokimab in eosinophilic asthma and plans to initiate a multi-dose Phase 2b randomized, double-blinded, placebo-controlled trial in 300-400 eosinophilic asthma patients in the fourth quarter of 2019.

The Company is also conducting its ATLAS trial, a Phase 2b randomized, double-blinded, placebo-controlled, multi-dose study in approximately 300 adult patients with moderate-to-severe atopic dermatitis. The study is designed to assess different dose levels and dosing frequencies of subcutaneously-administered etokimab, with top-line data expected in the fourth quarter of 2019.

AnaptysBio is conducting a randomized, placebo-controlled Phase 2 trial in approximately 100 adult patients with chronic rhinosinusitis with nasal polyps, also referred to as the ECLIPSE trial. Patients are being treated with two multi-dosing frequencies of subcutaneously-administered etokimab or placebo, each in combination with mometasone furoate nasal spray as background therapy. The Company anticipates interim top-line data from the ECLIPSE trial in the fourth quarter of 2019.

ANB019 (Anti-IL-36 Receptor) Program

The Company is conducting a single arm, open-label Phase 2 trial of ANB019 in up to 10 patients with generalized pustular psoriasis, or GPP, also known as the GALLOP trial, with interim top-line data expected in mid-2019.

The Company is conducting a randomized, placebo-controlled, multi-dose Phase 2 trial in 50 patients with palmoplantar pustulosis, or PPP, also known as the POPLAR trial, with top-line data anticipated in the first half of 2020.

ANB030 (Anti-PD-1 Agonist) Program

ANB030 is a wholly-owned antibody that binds PD-1 in an agonistic manner, leading to reduced T cell activity and anti-inflammatory effects in vivo. Genetic mutations in the PD-1 pathway are associated with increased susceptibility to various inflammatory conditions and we believe ANB030 has the potential to suppress inflammatory diseases by restoring insufficient PD-1-mediated negative signaling on activated T cells. The Company plans to focus future clinical development of ANB030 on certain autoimmune diseases where PD-1 checkpoint receptor function may be under-represented and anticipates filing an Investigational New Drug Application (IND) in the fourth quarter of 2019. Preclinical data from the ANB030 was presented in June at the 2019 FOCIS Annual Meeting.
Second Quarter Financial Results

Cash, cash equivalents and investments totaled $467.9 million as of June 30, 2019 compared to $500.2 million as of December 31, 2018, for a decrease of $32.3 million. The decrease relates primarily to cash used for operating activities.

Collaboration revenue was $5.0 million for the three and six months ended June 30, 2019, which related to a milestone for initiation of a Phase 3 trial in a second indication for dostarlimab, the anti-PD-1 antagonist antibody partnered with TESARO, a GlaxoSmithKline (GSK) company, compared to no revenue for the three and six months ended June 30, 2018.

Research and development expenses were $27.4 million and $48.0 million for the three and six months ended June 30, 2019, compared to $10.6 million and $22.4 million for the three and six months ended June 30, 2018. The increase was due primarily to continued advancement of the Company’s etokimab and ANB019 clinical programs and additional personnel-related expenses, including share-based compensation.

General and administrative expenses were $4.3 million and $8.4 million for the three and six months ended June 30, 2019, compared to $3.8 million and $7.8 million for the three and six months ended June 30, 2018. The increase was due primarily to additional personnel-related expenses, including share-based compensation.

Net loss was $24.0 million and $46.0 million for the three and six months ended June 30, 2019, or a net loss per share of $0.89 and $1.70, compared to a net loss of $13.6 million and $28.7 million for the three and six months ended June 30, 2018, or a net loss per share of $0.57 and $1.20.
Financial Guidance
AnaptysBio expects that its cash, cash equivalents and investments will fund its current operating plan at least through the end of 2020.
About Etokimab
Etokimab, previously referred to as ANB020, is an antibody that potently binds and inhibits the activity of interleukin-33, or IL-33, a pro-inflammatory cytokine that multiple studies have indicated is a central mediator of atopic diseases, which AnaptysBio believes is broadly applicable to the treatment of atopic inflammatory disorders, such as atopic dermatitis, eosinophilic asthma, chronic rhinosinusitis with nasal polyps, or CRSwNP, and potentially other allergic conditions. Following completion of a healthy volunteer Phase 1 trial of etokimab, AnaptysBio continued clinical development of etokimab into a Phase 2a trial for moderate-to-severe adult atopic dermatitis and a placebo-controlled Phase 2a trial in severe adult eosinophilic asthma patients. AnaptysBio is conducting its ATLAS trial, a randomized, double-blinded, placebo-controlled multi-dose Phase 2b clinical trial of etokimab in approximately 300 moderate-to-severe adult atopic dermatitis patients where top-line data is anticipated in the fourth quarter of 2019. The Company is conducting its ECLIPSE trial, a randomized, double-blinded, placebo-controlled Phase 2 trial of etokimab in approximately 100 adult patients with CRSwNP with interim top-line data anticipated in the fourth quarter of 2019. AnaptysBio also plans to initiate a randomized, double-blinded, placebo-controlled, multi-dose Phase 2b trial of etokimab in patients with eosinophilic asthma in the fourth quarter of 2019.

About ANB019
ANB019 is an antibody that inhibits the function of the interleukin-36-receptor, or IL-36R, which AnaptysBio plans to initially develop as a potential first-in-class therapy for patients suffering from generalized pustular psoriasis, or GPP, and palmoplantar pustulosis, or PPP. AnaptysBio has previously presented data from a Phase 1 clinical trial, which demonstrated favorable safety, pharmacokinetics and pharmacodynamic properties that supported advancement of ANB019 into Phase 2 studies. AnaptysBio is conducting its GALLOP trial, a Phase 2 study of ANB019 in GPP where interim top-line data is anticipated in mid-2019, and its POPLAR trial, a Phase 2 study in PPP where top-line data is anticipated in the first half of 2020.
About AnaptysBio
AnaptysBio is a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation. The Company’s proprietary anti-inflammatory pipeline includes its anti-IL-33 antibody etokimab, previously referred to as ANB020, for the treatment of moderate-to-severe atopic dermatitis, eosinophilic asthma, and adult chronic rhinosinusitis with nasal polyps, or CRSwNP; its anti-IL-36R antibody ANB019 for the treatment of rare inflammatory diseases, including generalized pustular psoriasis, or GPP, and palmoplantar pustulosis, or PPP; and its PD-1 agonist program, ANB030, and other novel anti-inflammatory checkpoint receptor modulator antibodies for treatment of certain autoimmune diseases where immune checkpoint receptors are insufficiently activated. AnaptysBio’s antibody pipeline has been developed using its proprietary somatic hypermutation, or SHM platform, which uses in vitro SHM for antibody discovery and is designed to replicate key features of the human immune system to overcome the limitations of competing antibody discovery technologies. AnaptysBio has also developed multiple therapeutic antibodies in an immuno-oncology partnership with TESARO, a GSK company, including an anti-PD-1 antagonist antibody (dostarlimab (TSR-042)), an anti-TIM-3 antagonist antibody (TSR-022) and

On August 8, 2019 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company focused on the development and commercialization of therapeutics for people living with kidney disease, reported financial results for the second quarter ended June 30, 2019 (Press release, Akebia, AUG 8, 2019, View Source [SID1234538410]). The Company will host a conference call today, Thursday, August 8, 2019, at 9:00 a.m. Eastern Time to discuss its second quarter 2019 financial results and recent business highlights.

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"Akebia continues to make great progress advancing our strategy. Fueled by strong operational execution, we increased Auryxia revenue by 21 percent compared to the same period last year and reinforced the strength of our Auryxia intellectual property with an important ANDA settlement. We also achieved significant milestones with our development program for vadadustat, including a JNDA submission that we believe may establish vadadustat as the first oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) to file for regulatory approval for the treatment of anemia due to chronic kidney disease (CKD) in both dialysis dependent and non-dialysis dependent adult patients in a major market," stated John P. Butler, President and Chief Executive Officer of Akebia. "While there is still much work ahead of us, we remain confident and believe we have tremendous opportunities to advance our mission to better the lives of people with kidney disease and deliver significant value to all our stakeholders. We’ve been very purposeful in developing our strategy, and it’s great to see the benefits of our work coming to light as the team continues to systematically execute on our priorities."

Butler continued, "We’re excited by the opportunities to continue advancing Auryxia’s long-term growth story. The 26 percent sequential revenue growth we achieved over the first quarter demonstrates that the team is successfully executing against our near-term growth initiatives. The prescription demand that

we’ve seen in the first four weeks of the third quarter is the highest of any quarter since Auryxia was launched, affirming our confidence that Auryxia is on a solid growth trajectory. We believe continued progress on our growth initiatives and underlying market demand will drive increased revenue for Auryxia across the second half of the year."

Auryxia Highlights

Auryxia (ferric citrate) net product revenue increased 20.7 percent year-over-year to $29.1 million for the second quarter of 2019, and increased 26 percent when compared with the first quarter of 2019. Total Auryxia prescriptions increased 22 percent year-over-year to 49,200 in the second quarter of 2019.

In August, Akebia settled Auryxia patent litigation with Par Pharmaceutical, Inc. (Par), resolving patent litigation brought in response to an Abbreviated New Drug Application (ANDA) filing by Par. The settlement allows Par to market its generic version of Auryxia in the United States beginning on March 20, 2025 (subject to U.S. FDA approval), or earlier under certain circumstances customary for settlement agreements of this nature.

In July, Akebia’s collaboration partner, Japan Tobacco, Inc. and its subsidiary Torii Pharmaceutical Co., Ltd., reported positive top-line results from their pivotal Phase 3 comparative study evaluating Riona Tablets (generic name in Japan: ferric citrate hydrate) for the treatment of iron deficiency anemia (IDA) in adult patients in Japan. They have stated that they expect to file an application for approval of IDA as an additional indication for Riona in Japan upon successful completion of their Phase 3 program.

Vadadustat Highlights

In July, Mitsubishi Tanabe Pharma Corporation (MTPC), Akebia’s development and commercialization collaboration partner in Japan for vadadustat, submitted a Japanese New Drug Application (JNDA) to the Ministry of Health, Labor and Welfare in Japan for manufacturing and marketing approval of vadadustat as a treatment for anemia due to CKD. The JNDA is the first regulatory submission for marketing approval of vadadustat and, if approved, is expected to lead to the first launch of vadadustat worldwide. This JNDA submission triggered a $10 million milestone payment from MTPC to Akebia, which was received in August.

In April, Akebia completed enrollment in its global Phase 3 INNO2VATE studies evaluating the safety and efficacy of vadadustat in dialysis-dependent CKD subjects with anemia due to CKD. The Company continues to expect to report top-line data from both INNO2VATE studies in the second quarter of 2020, subject to the accrual of major adverse cardiovascular events (MACE).

Akebia expects enrollment in its global Phase 3 PRO2TECT studies evaluating the safety and efficacy of vadadustat in non-dialysis dependent CKD subjects with anemia due to CKD to be completed in 2019. The Company continues to expect to report top-line results in mid-2020, subject to the accrual of MACE.

Financial Results

Total revenue for the second quarter of 2019 was $100.8 million, compared to $48.8 million in the second quarter of 2018.

Auryxia net product revenue for the second quarter of 2019 was $29.1 million, compared to $24.1 million, as reported by Keryx Biopharmaceuticals, Inc. (Keryx) prior to its merger with the Company, during the same period in 2018. This represents a 20.7 percent increase in net product revenue from the second quarter of 2018 and a 26 percent increase compared to the first quarter of 2019. Auryxia is the Company’s FDA approved oral iron tablet to treat non-dialysis dependent adult CKD patients for IDA and dialysis-dependent adult CKD patients for hyperphosphatemia.

Collaboration revenue for the second quarter of 2019 was $71.7 million, compared with $48.8 million in the second quarter of 2018. The increase was primarily due to increased collaboration revenue of $11.4 million from Otsuka Pharmaceutical Co. Ltd (Otsuka), and $10.0 million from MTPC in accordance with the Company’s collaboration agreements. Otsuka began funding 80 percent of the development costs for vadadustat in the second quarter of 2019.

Cost of goods sold was $37.7 million for the second quarter of 2019, consisting of $9.6 million of costs associated with the manufacture of Auryxia and non-cash charges of $28.1 million related to the application of purchase accounting as a result of the merger with Keryx. These non-cash, merger-related charges include a $19.0 million inventory step-up charge and $9.1 million of amortization of intangibles.

Research and development expenses were $85.7 million for the second quarter of 2019 compared to $71.9 million for the second quarter of 2018. The increase was primarily attributable to an increase in external costs related to the continued advancement of the PRO2TECT and INNO2VATE Phase 3 studies of vadadustat as well as increases in headcount to support our research and development programs.

Selling, general and administrative expenses were $36.1 million for the second quarter of 2019 compared to $12.5 million for the second quarter of 2018. The increase in selling, general and administrative expenses was primarily attributable to commercialization costs associated with Auryxia, as there were no comparable commercialization costs in the second quarter of 2018.

The Company reported a net loss for the second quarter of 2019 of $58.2 million, or ($0.49) per share, as compared to a net loss of $34.1 million, or ($0.60) per share, for the second quarter of 2018. The Company’s net loss for the second quarter of 2019 includes the impact of non-cash charges of $28.1 million related to the application of purchase accounting as a result of the merger with Keryx.

The Company ended the quarter with cash, cash equivalents and available-for-sale securities of $136.8 million. "As we continue to effectively manage and leverage our operations, we expect our cash resources, including committed research and development funding from collaborators, to fund our current operating plan beyond the next twelve months, into the third quarter of 2020," stated Jason A. Amello, Chief Financial Officer of Akebia.

Conference Call

Akebia will host a conference call today, Thursday, August 8, 2019, at 9:00 a.m. Eastern Time to discuss its second quarter 2019 financial results and recent business updates. To listen to the conference call, please dial (877) 458-0977 (domestic) or (484) 653-6724 (international) using conference ID number 7274126. The call will also be webcast LIVE and can be accessed via the Investors section of the Company’s website at View Source

A replay of the conference call will be available two hours after the completion of the call through August 14, 2019. To access the replay, dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and reference conference ID number 7274126. An online archive of the conference call can be accessed via the Investors section of the Company’s website at View Source

On August 8, 2019 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) reported financial results for the second quarter ended June 30, 2019 and provided a business update(Press release, Adamis Pharmaceuticals, AUG 8, 2019, View Source [SID1234538409]).

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Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, stated, "I believe the most significant event in the second quarter was Sandoz’s full launch of our SYMJEPITM epinephrine injection product in the U.S. The retail launch in July, made both doses of SYMJEPI available for patients and caregivers. With shortages in the market over the last year, we hope SYMJEPI can help meet the demand for this potentially lifesaving drug. We also are looking forward to a potential FDA approval for our ZIMHITM naloxone injection product candidate. If approved, we hope to be in position to assist in the effort to combat the ongoing public health crisis of opioid overdose."

"Also noteworthy was the recent resolution of all the outstanding patent litigation relating SYMJEPI and ZIMHI. In addition, by closing the public offering that we announced last week, we added additional cash to our balance sheet to provide the necessary runway to give the company the best chance to achieve some of our near-term goals and the potential for revenue growth from SYMJEPI and our U.S. Compounding division to reach levels that could bring us to our goal of profitability."

Product Updates

SYMJEPI (epinephrine) Injection

On July 9, 2019, Sandoz announced the full launch of our SYMJEPI epinephrine injection product in the U.S., making both the 0.3mg and 0.15mg doses available in local pharmacies across the nation. The company is hopeful that Sandoz’s marketing efforts, combined with the ongoing shortage of epinephrine injection products in the market will begin to increase sales of SYMJEPI and cash to Adamis by the end of 2019.

ZIMHI (naloxone) Injection

On March 14, 2019, Adamis announced that the FDA had accepted the company’s New Drug Application (NDA) for review and provided a target agency action date (PDUFA) of October 31, 2019. The company believes that if approved, ZIMHI could be an important part of the solution to this growing health crisis of opioid overdose. The company is in discussions with several potential partners for ZIMHI with the goal of finalizing a commercial distribution agreement for the U.S. prior to a potential approval.

Drug Outsourcing Facility

During the second quarter of 2019, the company’s wholly owned drug outsourcing facility, US Compounding (USC), continued to grow revenues and margins. USC continued to improve in the second quarter and the company expects the division to be net positive for Adamis in the second half of 2019.

Other Developments

On July 18, 2019, Adamis announced it had settled all pending litigation with kaléo Inc. As part of the settlement the parties agreed to voluntarily dismiss both the pending patent and trademark cases. Furthermore, kaléo agreed not to bring future action against Adamis relating to ZIMHI so long as Adamis does not reference kaléo’s product in a future filing with the FDA. In turn, Adamis agreed not to bring future action against kaléo for acts that occurred prior to the settlement.

On July 24, 2019, the company announced it had settled all pending litigation with Belcher Pharmaceuticals regarding certain Belcher patents relating to methods of preparing epinephrine. As part of the settlement Belcher provided Adamis a worldwide, non-exclusive, fully paid-up, royalty-free license for certain patent claims relating to SYMJEPI and agreed not to bring future action against Adamis relating to ZIMHI. In exchange Adamis agreed to voluntarily withdraw both the patent case in Florida and the IPR filed with the United States Patent and Trademark Office.

Second Quarter 2019 Financial Results

Revenues for the second quarter grew 17.5% over the first quarter of 2019 (approximately $5.8 million and $4.9 million, respectively), and increased 47.0% over the $3.9 million for the comparable period of 2018. The increase was primarily attributable to continued growth in sales of USC’s sterile pharmaceutical products and manufacturing revenue relating to the non-retail launch of SYMJEPI.

Selling, general and administrative expenses during the second quarter of 2019 decreased 12.7% from the first quarter of 2019 (approximately $7.0 million and $8.0 million, respectively). This decrease was mostly the result of restructuring, including reductions of personnel, at USC.

Research and development ("R&D") expenses were approximately $2.8 million for the second quarter of 2019 compared to approximately $2.2 million in the first quarter of 2019; however, R&D expenses decreased 41.2% from the same quarter in 2018. We anticipate that R&D expenses will decrease in the second half of 2019.

Cash and equivalents at the end of the second quarter was approximately $4.1 million, and net proceeds from last week’s firm commitment underwritten public offering transaction were approximately $12.7 million. Our goal for the second half of 2019 is to keep cash expenditures, that is, cash used in operating and investing activities, in the range of $7 – 8 million. If we meet our spending goals for the remainder of 2019, it should represent a reduction of approximately 37% from the Net Cash used in Operating and Investing Activities for the comparable period of 2018.

Targeted Milestones for Remainder of 2019

● Growth in sales of the SYMJEPI in the U.S.
● FDA approval for ZIMHI
● Commercial partner for ZIMHI
● Commercial partner(s) for SYMJEPI for territories outside of the U.S.
● US Compounding begins to contribute cash to Adamis

Conference Call

Adamis will host a conference call and live webcast today, August 8, 2019 at 2:00 pm PDT (5:00 pm EDT) to discuss its financial and operating results for the second quarter 2019, as well as provide an update on business developments and activities.

US Dial-in (Toll Free): 1-866-288-0540

TOLL/International Dial-In: 1-323-994-2131

Conference ID: 4399286

Webcast: View Source

If you are unable to participate in the call live, a telephone playback will be available after approximately 5:00 pm PDT on August 8, 2019. To listen to the replay, call toll free 1-844-512-2921 within the U.S. or 1-412-317-6671 internationally (toll) and enter PIN number 4399286.