On August 8, 2018 Nektar Therapeutics (Nasdaq: NKTR) reported its financial results for the second quarter ended June 30, 2018 (Press release, Nektar Therapeutics, AUG 8, 2018, View Source [SID1234528537]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Cash and investments in marketable securities at June 30, 2018 were $2.1 billion as compared to $353.2 million at December 31, 2017. This includes the $1.0 billion upfront payment and $850.0 million share purchase proceeds received on April 3, 2018, as a result of our Bristol-Myers Squibb collaboration for the global development and commercialization of NKTR-214.

"Over the past few months, we have reported significant progress across all areas of our pipeline, with notable milestones for our immuno-oncology, immunology and pain programs," said Howard W. Robin, President and CEO of Nektar. "Together with Bristol-Myers Squibb, we plan to initiate 20 registrational studies in nine tumor settings under our joint development plan with the first wave of studies in melanoma, renal cell carcinoma, and urothelial cancers starting this year. We initiated our first study of NKTR-358 in patients with lupus with our partner Eli Lilly. And importantly, we recently achieved a significant milestone for our pain program, with the FDA’s acceptance of the NDA filing for NKTR-181, a first-in-class opioid analgesic."

Revenue in the second quarter of 2018 was $1.088 billion as compared to $34.6 million in the second quarter of 2017. Year-to-date revenue for 2018 was $1.126 billion as compared to $59.3 million in the first half of 2017. Revenue was higher in the second quarter and first half of 2018 as compared to the same periods in 2017 primarily because of the recognition of $1.06 billion of license revenue from the Bristol-Myers Squibb collaboration agreement.

Total operating costs and expenses in the second quarter of 2018 were $114.1 million as compared to $85.2 million in the second quarter of 2017. Total operating costs and expenses in the first half of 2018 were $238.9 million as compared to $164.4 million in the first half of 2017. Total operating costs and expenses increased primarily as a result of increased research and development (R&D) expense.

R&D expense in the second quarter of 2018 was $88.3 million as compared to $60.3 million in the second quarter of 2017. For the first half of 2018, R&D expense was $187.8 million as compared to $121.3 million in the first half of 2017. R&D expense was higher in the second quarter and first half of 2018 as compared to the same periods in 2017 primarily because of expenses for our pipeline programs, including the continued development of NKTR-214 in Phase 1/2 studies and Phase 3 preparatory activities, costs related to the NKTR-181 New Drug Application and NKTR-181 pre-commercial manufacturing, Phase 1 clinical studies of NKTR-358, initiation of the Phase 1 study of NKTR-262 in combination with NKTR-214 and IND-enabling activities for NKTR-255.

General and administrative (G&A) expense was $20.3 million in the second quarter of 2018 as compared to $16.0 million in the second quarter of 2017. G&A expense in the first half of 2018 was $38.9 million as compared to $28.0 million in the first half of 2017. G&A expense was higher in the second quarter and first half of 2018 as compared to the same periods in 2017 primarily due to an increase in non-cash stock based compensation expense.

Net income in the second quarter of 2018 was $971.5 million or $5.33 diluted earnings per share as compared to a net loss of $59.9 million or $0.39 basic and diluted loss per share in the second quarter of 2017. Net income in the first half of 2018 was $875.7 million or $4.91 diluted earnings per share as compared to a net loss of $123.7 million or $0.80 basic and diluted loss per share in the first half of 2017.

Second Quarter 2018 and Recent Business Highlights

In July, the U.S. Food and Drug Administration filed and accepted a New Drug Application (NDA) for NKTR-181, a first-in-class opioid analgesic, to treat chronic low back pain in adult patients new to opioid therapy. The NDA has been assigned a PDUFA (Prescription Drug User Fee Act) target action date of May 29, 2019 by the FDA.
In June, Nektar presented data for NKTR-181 at the 80th Annual Scientific Meeting of the College on Problems of Drug Dependence. The data show that NKTR-181 consistently demonstrates low abuse potential.
In June, Nektar presented data from the Phase 1 dose escalation and preliminary data from the Phase 2 dose expansion phase of the ongoing PIVOT study for NKTR-214 in combination with Opdivo (nivolumab) at the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting. This data showed that pre-specified efficacy criteria were achieved in three tumor types: first-line melanoma, first-line renal cell carcinoma and first-line urothelial cancer. Nektar and Bristol-Myers Squibb expect to initiate a Phase 3 registrational trial in first-line advanced melanoma patients in Q3 2018, and pivotal studies are also being designed in renal cell carcinoma and urothelial cancer.
In May, Nektar announced a clinical collaboration with Syndax Pharmaceuticals to evaluate NKTR-214 in combination with entinostat, an oral, small molecule Class 1 specific HDAC inhibitor, in patients with metastatic melanoma who have previously progressed on treatment with an anti-PD-1 agent.
In May, Nektar began dosing patients with systemic lupus erythematosus in a Phase 1b multiple ascending dose study of NKTR-358, a first-in-class regulatory T cell stimulator, designed to correct the underlying immune system dysfunction found in patients with immune disorders.
The company also announced the following upcoming presentations during the second half of 2018:

American Chemical Society Annual Meeting, Boston, MA:

Oral Presentation: "Confronting the Opioid Epidemic: Novel Treatments for Chronic Pain"
Presenter: Stephen Doberstein, Ph.D., Nektar Therapeutics
Date: Monday, August, 20, 2018, 1:35 p.m. – 2:05 p.m., Eastern Daylight Time
SMI Immuno-Oncology Conference, London, UK:

Oral Presentation: "Enhanced cancer vaccine effectiveness with NKTR-214, a CD122-biased cytokine"
Presenter: Loui Marakamutil, Ph.D., Nektar Therapeutics
Date: September 26, 2018, 11:00 a.m., British Summer Time
Ninth American Conference on Pharmacometrics, San Diego, CA:

Poster: "NKTR-255 Exhibits Target Mediated Drug Disposition and Stimulates Proliferation of Cytotoxic Immune Cells in Cyonomolgous Monkeys", Bhasi, K., et al.
Date: October 6-12, 2018
ESMO 2018 Congress, Munich, Germany:

Poster 362TiP: "ATTAIN: Phase 3 study of etirinotecan pegol (EP) vs treatment of physician’s choice (TPC) in patients (pts) with metastatic breast cancer (MBC) who have stable brain metastases (BM) previously treated with an anthracycline, a taxane, and capecitabine (ATC).", Tripathy, D., et al.
Date: October 22, 2018, 12:45-13:45 p.m. Central European Summer Time
Poster 446TiP: "REVEAL: A phase 1/2, open-label, multicenter, dose escalation and dose expansion study of NKTR-262 [TLR 7/8 agonist] plus NKTR-214 [CD122-biased agonist] with or without nivolumab (nivo) in patients (pts) with locally advanced or metastatic solid tumor malignancies.", Diab, A., et al.
Date: October 22, 2018, 12:45-13:45 p.m. Central European Summer Time
Conference Call to Discuss Second Quarter 2018 Financial Results

Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time today, Wednesday, August 8, 2018.

This press release and a live audio-only Webcast of the conference call can be accessed through a link that is posted on the home page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through Monday, September 10, 2018.

To access the conference call, follow these instructions:

Dial: (877) 881.2183 (U.S.); (970) 315.0453 (international)

Passcode: 7099844 (Nektar Therapeutics is the host)

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

On August 8, 2018 Quanterix Corporation (NASDAQ:QTRX), a company digitizing biomarker analysis to advance the science of precision health, reported financial results for the three months and six months ended June 30, 2018 (Press release, Quanterix, AUG 8, 2018, View Source [SID1234528553]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are continuing to achieve strong momentum, as made evident by our performance in this second quarter, showing steady growth in terms of both product and company revenue," said Chief Executive Officer, President and Chairman, Kevin Hrusovsky. "We are at a pivotal point in our industry, where biomarkers are being recognized as increasingly representing a critical opportunity for accelerating drug approvals and helping to fuel demand for our technology for pharma services and drug development."

Second Quarter 2018 Financial Highlights
Key financial results for the second quarter are shown below:

Q2 revenue of $8.6M versus prior year Q2 of $5.2M, an increase of 66%.
Q2 product revenue was $5.2M versus prior year Q2 of $3.3M, an increase of 56%.
Q2 Service and Other revenue totaled $3.2M versus prior year Q2 of $1.6M, an increase of 97%.
YTD 2018 Financial Highlights
Key financial results for 2018 YTD are shown below:

YTD revenue of $16.2M versus prior year $10.6M, an increase of 53%.
YTD product revenue of $9.9M versus prior year $6.8M, an increase of 47%.
YTD Service and Other revenue of $5.7M versus prior year $3.3.M, an increase of 75%.
Second Quarter 2018 Business Highlights

SR-X platform momentum continues to build, with 22 assays now available
Cadence of publications continued to increase with 40 new publications featuring Simoa technology in Q2 alone, bringing total to >250
Continued commercial acceleration in Pharma Services, including significant build out of CLIA lab capabilities to handle increased sample volume
Major presence at American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2018 Annual Conference, broadening reach into oncology and liquid tumor biopsy market
Kevin Hrusovsky invited to speak at PULSE: The Atlantic Summit on Healthcare
Attendance at 10 industry tradeshows and conferences in North America and Europe spanning multiple therapeutic areas
Created new integrated marketing and inside sales lead generation team to fuel accelerated pipeline development
Developed and began promoting a major webinar scheduled in September on "Disrupting Drug Development with Digital Biomarkers" featuring Kevin Hrusovsky, CEO and Chairman of Quanterix, Dr. Henrik Zetterberg of the University of Gothenburg, and Dr. Andy Nixon of Duke University
Conference Call
In conjunction with this announcement, Quanterix Corporation will host a conference call on August 8, 2018, at 4:30 p.m. EDT to discuss the Company’s financial results and business outlook. To access this call, dial (833) 686-9351 for domestic callers, or (612) 979-9890 for international callers. Please reference the following conference ID: 4299369.

A live webcast will be accessible on the Investors section of Quanterix’ website: View Source The webcast will be available on the Company’s website for one year following completion of the call.

On August 8, 2018 Context Therapeutics, a clinical stage biopharmaceutical company dedicated to the treatment of hormone driven cancers, reported it has signed multiple research collaborations to further understand the role of progesterone receptor (PR) signaling and its blockade to overcome resistance mechanisms underlying metastatic breast cancer (mBCa) (Press release, Context Therapeutics, AUG 8, 2018, View Source [SID1234528579]). These collaborations are with key leaders in the progesterone and breast cancer fields and include Dr. Carol Lange, PhD at University of Minnesota and Dr. Suzanne Fuqua, PhD at Baylor College of Medicine, both of whom also serve as Scientific Advisory Board members at Context. Additional academic collaborations include the laboratories of Dr. Sarat Chandarlapaty, MD, PhD at Memorial Sloan Kettering Cancer Center, Dr. Geoffrey Greene, PhD at University of Chicago and Dr. Seema Khan, MD at Northwestern University.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Breast cancer is the most commonly diagnosed cancer and the second leading cause of cancer related death in women. Approximately 155,0002 women in the United States have mBCa and the median overall survival in this setting is three years. Three primary mBCa subtypes exist: hormone receptor positive (HR+) that express estrogen receptor (ER) and/or progesterone receptor (70-80% of patients); human epidermal growth factor receptor 2 (HER2)-positive (10-15%); and triple negative (10-17%). For patients with HR+ mBCa, antiestrogen blockade is the backbone therapy across first (1L) and second (2L) treatment lines. Unfortunately, current treatments in 1L and 2L are not curative and only delay progression to chemotherapy. Therefore, there is a critical need for targeting additional mechanisms alone or in combination with antiestrogens to enhance therapeutic response and provide these patients with better outcomes.

Progesterone, a major mitogen in the adult human mammary epithelium, is also a key driver of breast cancer cell proliferation. Context Therapeutics is pursuing an innovative approach to the treatment of advanced breast cancer by blocking both ER and PR, the primary drivers of HR+ mBCa disease progression, through the combination of Apristor, a unique PR full antagonist, with the antiestrogen Falsodex (fulvestrant). Apristor has established efficacy as an antitumor agent in this setting, as well as in multiple preclinical breast cancer models and exhibits additive/synergistic effects with antiestrogens, providing a strong rationale for this combination.

A Phase 2 clinical trial in advanced breast cancer patients with Apristor in combination with Fulvestrant in 2L therapy is planned for early 2019. The randomized, double-blind, placebo-controlled study will be powered to show efficacy with Apristor added to the standard of care (Fulvestrant) versus the standard of care alone.

The research at the above academic centers will focus on expanding the understanding of mechanisms underlying resistance in breast cancer and novel therapeutic combinations that could be useful in treating advanced breast cancer with Apristor.

Under the terms of the collaborations, Context will provide Apristor and collaborate with the research groups. While it is well known that Apristor is a unique PR antagonist8 that inhibits both ligand-dependent and growth factor induced PR activities, access to the drug for basic research purposes has been historically limited. Context is providing the compound to key interested academic partners with the aim of advancing breast cancer research and understanding the role of PR signaling in mammary tumors and other indications.

About Progesterone Receptor Antagonism

Context is developing Apristor, a first-in-class orally-bioavailable progesterone receptor (PR) antagonist for PR+ breast cancer. Up to 60% of breast cancer patients are believed to be PR+. Apristor is an investigational medicine that has completed Phase 1 development and will be further evaluated in an upcoming randomized, placebo-controlled Phase 2 trial in second-line metastatic breast cancer patients who are PR+ and have failed prior antiestrogen therapeutic with or without the addition of a Cdk4/6 inhibitor.

On August 8, 2018 BeiGene, Ltd. (NASDAQ:BGNE), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported the closing of its previously announced Hong Kong initial public offering and global offering (the "Offering") of 65,600,000 ordinary shares, par value $0.0001 per share (the "Shares"), at a public offering price of HK$108.00 per Share (Press release, BeiGene, AUG 8, 2018, View Source;p=RssLanding&cat=news&id=2362884 [SID1234528621]). Based on an assumed exchange rate of HK$7.8478 to US$1.00, the public offering price equates to US$13.76 per Share, or US$178.90 per American Depositary Share ("ADS"). BeiGene’s ADSs are currently listed on the Nasdaq Global Select Market under the symbol "BGNE" and each ADS represents 13 ordinary shares. The Shares began trading today on the Main Board of the Stock Exchange of Hong Kong Limited under the stock code "06160".

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The gross proceeds to BeiGene from the Offering, before deducting underwriting discounts and commissions and other offering expenses, are approximately HK$7.08 billion, or approximately US$903 million. In addition, BeiGene has granted the joint global coordinators a 30-day option to purchase up to an additional 9,840,000 Shares at the public offering price, less underwriting discounts and commissions.

BeiGene intends to use net proceeds from the Offering for clinical trials, preparation for registration filings, and for the launch and commercialization of its core product candidates (zanubrutinib, tislelizumab, and pamiparib), as well as to fund continued expansion of its product portfolio in cancer and potentially other therapeutic areas, and for working capital, expanding internal capabilities, and general corporate purposes.

Morgan Stanley & Co. International plc, Goldman Sachs (Asia) L.L.C., Credit Suisse (Hong Kong) Limited and CLSA Limited acted as joint global coordinators, joint bookrunners and joint lead managers for the Global Offering. China International Capital Corporation Hong Kong Securities Limited, Deutsche Bank AG, Hong Kong Branch, UBS AG Hong Kong Branch acted as joint bookrunners and joint lead managers. China Renaissance Securities (Hong Kong) Limited acted as joint lead manager.

Sales of Shares outside of Hong Kong, initially offered in the United States and sold outside the United States that may be resold from time to time in the United States, are being offered pursuant to an automatically effective shelf registration statement that was previously filed with the U.S. Securities and Exchange Commission (the "SEC"). The final prospectus supplement relating to and describing the terms of the Offering was filed with the SEC on August 3, 2018 and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to these securities may be obtained for free from the offices of Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, or email:[email protected]; and Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, One Madison Avenue, New York, New York 10010, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

On August 8, 2018 German biopharma company MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; NASDAQ: MOR) and I-Mab Biopharma ("I-Mab"), a Shanghai-based biotech company focused on innovative biologics in oncology and autoimmune diseases, reported that I-Mab has submitted an investigational new drug (IND) application to China National Drug Administration (CNDA) for TJ202/MOR202, a human monoclonal antibody directed against CD38 for the treatment of multiple myeloma (Press release, MorphoSys, AUG 8, 2018, View Source [SID1234528538]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Multiple myeloma is the second most common blood cancer worldwide. The patient number has gradually increased in China in recent years due to an increasingly aging population. Yet there are no effective biologics approved in China for this indication and current therapies have been associated with serious side effects and limited treatment efficacy.

TJ202/MOR202 is a monoclonal antibody derived from MorphoSys’s HuCAL antibody technology. The antibody is directed against CD38 on the surface of multiple myeloma cells, and, according to its suggested mode of action, recruits cells of the body’s immune system to kill the tumor. Scientific research suggest that an anti-CD38 antibody may have therapeutic potential also in other cancers, as well as autoimmune diseases.

China recently issued a new round of reform initiatives to accelerate clinical trial approval for new drugs, especially in oncology. "The IND submission was done after a successful pre-submission consultation meeting with Center for Drug Evaluation (CDE) of CNDA, which is required under China’s new drug regulation, unless waived," said Dr. Joan Shen, Head of R&D at I-Mab.

"CNDA has endorsed the overall clinical and regulatory strategy, as well as the study designs, which should lead to the biologics license application (BLA)," said Dr. Joan Shen.

Through a licensing agreement with MorphoSys AG in November 2017, I-Mab gained exclusive rights to develop and commercialize TJ202/MOR202 in Greater China territory, including mainland China, Hong Kong, Macau and Taiwan.

After observing patient responses in an interim analysis from an ongoing Phase 1/2a trial in patients with relapsed/refractory multiple myeloma in Germany and Austria, MorphoSys decided to support I-Mab to lead clinical development of TJ202/MOR202 in Greater China. MorphoSys will continue to evaluate additional other suitable indications for further global development of TJ202/MOR202.

Dr. Malte Peters, Chief Development Officer of MorphoSys AG commented: "We are delighted that our partner I-Mab has taken this important step in advancing TJ202/MOR202 into clinical development in China. We look forward to supporting I-Mab in developing this investigational compound with the goal of helping Chinese patients in multiple myeloma, an indication with a high unmet medical need."

"With a fast-to-market strategy under the new drug regulation, we hope to bring this innovative treatment to patients as soon as possible," Dr. Shen commented. "MorphoSys and I-Mab plan to continuously evaluate the potential and further development of TJ202 in other indications."