On November 6, 2019 CStone Pharmaceuticals ("CStone" or the "Company", HKEX: 2616) reported that an abstract on the CS1001-201 trial (Abstract #2833) was accepted by the 2019 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and has been published online yesterday on the meeting’s official website (Press release, CStone Pharmaceauticals, NOV 6, 2019, View Source;cstones-anti-pd-l1-antibody-demonstrates-a-complete-response-rate-of-31-8-in-patients-with-relapsed-or-refractory-extranodal-natural-killert-cell-lymphoma-300953456.html [SID1234550510]). Additionally, the Company will release further updated data from the CS1001-201 trial in a poster presentation at the conference.

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CS1001-201 is a single-arm, multicenter Phase II clinical study designed to evaluate CS1001 monotherapy in relapsed or refractory extranodal natural killer (NK)/T-cell lymphoma (rr-ENKTL). The primary endpoint of the trial is objective response rate (ORR) assessed by an independent radiological review committee (IRRC); the secondary endpoints include investigator-assessed ORR, IRRC-assessed complete and partial response (CR, PR) rates, time to response, duration of response, progression-free survival, overall survival, and safety.

ENKTL is a subtype of mature T cell and NK cell lymphoma, with a higher incidence in Asia than in Europe or North America. ENKTL is an aggressive malignancy characterized by its rapid progression and poor prognosis. Patients with rr-ENKTL lack effective standard treatment after failing an L-asparaginase-based combination chemotherapy regimen. Studies to date have shown that Epstein-Barr virus (EBV) infection is linked to the pathogenic mechanisms of ENKTL, as EBV infection induces immune tolerance by upgrading PD-L1 expression in tumor cells, thus promoting tumor growth.

"In China, ENKTL accounts for approximately 6% of all lymphoma incidences, and those relapsed or refractory patients in particular have urgent unmet clinical needs. CS1001-201 is the first clinical trial worldwide investigating an anti-PD-L1 antibody in ENKTL patients, and promising initial antitumor activity has already been observed in the trial," said Dr. Frank Jiang, Chairman and CEO of CStone. "I am glad that the preliminary results from this trial will be announced for the first time at the 2019 ASH (Free ASH Whitepaper) Annual Meeting. CStone remains committed to addressing treatment gaps in China and around the world. We hope this trial will continue its rapid progress and soon produce more breakthroughs in the treatment of ENKTL."

CStone’s Chief Medical Officer, Dr. Jason Yang, noted: "The close association between ENKTL and the increased PD-L1 expression resulted by EBV infection suggests that blocking the PD-1/PD-L1 pathway could be an effective treatment for ENKTL patients. In the abstract published by ASH (Free ASH Whitepaper), CS1001 demonstrated an ORR of 40.9%, a complete and durable response rate of 31.8% and a benign safety profile. These results represent a major breakthrough in the treatment of rr-ENKTL and support the further development of CS1001 as a treatment for rr-ENKTL. We look forward to sharing encouraging additional data updates in the poster presentation at the 2019 ASH (Free ASH Whitepaper) Annual Meeting."

Results in the abstract published by ASH (Free ASH Whitepaper)

As of June 17, 2019, 29 patients were enrolled into the study. Among them, 22 (75.9%) patients had Stage IV of the disease at screening, 8 patients received 2 lines of prior treatments, and 6 patients received 3 or more lines of prior treatments. All of the patients received 1200 mg CS1001 intravenously every 3 weeks for up to 2 years, until disease progression, intolerance, etc. The median duration of follow-up was 5.55 (range, 0.69-12.19) months.

Demographics and baseline characteristics

15 (51.7%) of the 29 enrolled patients remained on treatment, and 14 (48.3%) had discontinued from the study treatment.
Reasons for discontinuations included disease progression (12 patients) and adverse events (AEs, 2 patients).
No discontinuations or deaths due to treatment-related AEs (TRAEs).
Preliminary efficacy data
CS1001 demonstrated promising antitumor activity in rr-ENKTL patients

Among the 22 efficacy-evaluable patients, the investigator-assessed ORR was 40.9%. 7 (31.8%) patients achieved complete and durable response.
2 (9.1%) patients achieved partial response (PR), and 1 additional patient achieved PR after pseudo-progression.
The duration of response (DoR) ranged from 0.03+ to 8.61+ months, and the median DoR was not reached.
The IRRC assessments were not available at the time of data cut-off.
Safety data

CS1001 was well tolerated in patients with rr-ENKTL

The median duration of treatment was 11.7 (range, 2.9 – 53.0) weeks.
25 (86.2%) patients reported treatment-emergent AEs (TEAEs).
21 (72.4%) patients reported treatment-related AEs (TRAEs), of which 3 (10.3%) had Grade ≥3 TRAEs.
Grade 5 AEs were reported in 2 patients, and none was assessed as related to CS1001.
Serious AEs were observed in 5 (17.2%) patients, and 1 of them (sinus node dysfunction) was assessed as related to CS1001 by the investigator.
Immune-related AEs (irAEs) were reported in 5 patients (17.2%). Except 1 Grade 3 rash, all irAEs were Grade 1 in severity.
TEAEs that led to permanent treatment discontinuation occurred in 2 (6.9%) patients; but no permanent discontinuation or death due to AEs were assessed as related to CS1001.
After data cut-off date, 3 additional patients reached the response assessment time point, of which 2 patients achieved CR, elevating the ORR to 44.0% (11/25) and CR rate to 36.0% (9/25). More details of the updated data will be reported at the 2019 ASH (Free ASH Whitepaper) Annual Meeting.

About CS1001

CS1001 is an investigational monoclonal antibody directed against PD-L1 being developed by CStone. Authorized by the U.S. based Ligand Corporation, CS1001 is developed by the OMT transgenic animal platform, which can generate fully human antibodies in one step. As a fully human, full-length anti-PD-L1 monoclonal antibody, CS1001 mirrors natural G-type immune globulin 4 (IgG4) human antibody, which can reduce the risk of immunogenicity and potential toxicities in patients, potentially representing a unique advantage over similar drugs.

CS1001 has completed a Phase I dose-escalation study in China, in which CS1001 showed good tolerability and produced sustained clinical benefits during Phase Ia and Ib stages of the study in multiple indications.

CS1001 is being investigated in a number of ongoing clinical trials, including one Phase I bridging study in the U.S. In China, its clinical program includes one multi-arm Phase Ib study, two pivotal Phase II studies, and three Phase III studies for several tumor types.

On November 6, 2019 Artios Pharma Limited (Artios), The University of Texas MD Anderson Cancer Center (MD Anderson) and ShangPharma Innovation (ShangPharma) reported the in-licensing by Artios of a small-molecule ATR inhibitor programme, developed jointly by MD Anderson and ShangPharma (Press release, Artios Pharma, NOV 6, 2019, View Source [SID1234550506]).

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Under the agreement, Artios has exclusive rights to research, develop, manufacture and commercialize products globally. The lead candidate is expected to be ready for Investigational New Drug (IND) application by the second half of 2020.

"This programme has the potential to be a highly effective DNA damage response (DDR) targeted treatment in cancer. We look forward to advancing the work done by MD Anderson and ShangPharma for the benefit of cancer patients," said Dr. Niall Martin, Chief Executive Officer at Artios Pharma. "The addition of the ATR programme further supports our position as a leader in the DDR space and strengthens our growing portfolio of assets, which includes a leading Polθ programme, currently in candidate IND evaluation, and a large discovery stage platform of novel DNA repair nuclease inhibitors."

The ATR inhibitor programme is the result of an extensive collaboration between MD Anderson’s Therapeutics Discovery team and ShangPharma. Therapeutics Discovery is a multidisciplinary team created within MD Anderson to advance the next generation of cancer therapies to answer unmet oncology needs.

"Targeting DNA damage repair has the potential to provide an important therapeutic option for many patients in need of new treatments," said Philip Jones, Ph.D., vice president of Therapeutics Discovery at MD Anderson. "We are pleased Artios will leverage its unique expertise in this field to advance this novel therapy toward the clinic to improve outcomes for cancer patients."

ATR[1] is an important signalling protein in DNA double strand break repair and replication stress. Through inhibition of ATR, tumours bearing an ATM[2] deficiency can be selectively killed through a concept known as synthetic lethality. High levels of ATM mutations and protein loss have been characterised across many different tumour types, creating a significant opportunity for ATR inhibitors clinically. Based on clinical observations at MD Anderson, Therapeutics Discovery engaged with ShangPharma and its affiliate, ChemPartner, to develop small-molecule inhibitors of the DDR that could benefit patients across multiple cancer types.

"We are proud of the entire collaboration team, including ChemPartner, led by Sarah Lively, Ph.D., vice president of Innovation and New Technologies, for advancing the programme from early-stage research to formal drug discovery and development," said Walter Moos, Ph.D., CEO of ShangPharma Innovation. "We are pleased to transition this important programme to the capable development team at Artios, and we hope this ultimately provides an impactful therapy for those afflicted with cancer."

On November 6, 2019 AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the use in medically supervised settings, reported that management will be presenting at the Credit Suisse 28th Annual Healthcare Conference to be held November 11 – 13 (Press release, AcelRx Pharmaceuticals, NOV 6, 2019, View Source [SID1234550499]). AcelRx management will provide an overview of the business and company updates during the live presentation and will be available for one-on-one meetings with investors.

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Details of the event are as follows:

Credit Suisse 28th Annual Healthcare Conference
Date: Wednesday, November 13, 2019
Location: The Phoenician, Scottsdale, AZ
Presentation Time: 9:10 am local time (11:10 a.m. ET)

The conference will be webcast live and can be accessed through the Investors page at www.acelrx.com. For those not available to listen to the live broadcast, a replay will be archived for 90 days and available through the Investors page on www.acelrx.com.

On November 6, 2019 Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis to advance the science of precision health, reported financial results for the three and nine months ended September 30, 2019 (Press release, Quanterix, NOV 6, 2019, View Source [SID1234550488]).

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"We are pleased with our execution and yet another record quarter with strong revenue growth, successful early launch of our new HD-X Analyzer and material progress accelerating global adoption of our ultra-sensitive Simoa technology," said Kevin Hrusovsky, Chief Executive Officer, President and Chairman, Quanterix. "We are excited to have accelerated the HD-X Analyzer shipments a quarter early and also to have strengthened our balance sheet with a successful follow-on offering. We believe our growth trajectory and financial performance speak for themselves. We remain confident in our impressive opportunity for value creation as we pioneer disruption in healthcare. Our next major opportunity to advance our commercial momentum is by participating in the upcoming Powering Precision Health Summit in Barcelona, Spain on November 19, 2019 where over 40 top researchers are lined up to present on the disruptive potential of biomarker technology to transform drug development and enable a sea change advance in precision health."

Third Quarter 2019 Financial Highlights

Key financial results for the third quarter of 2019 are shown below:

·Q3 revenue was $14.9M versus prior year Q3 of $10.6M, an increase of 41%; Excluding $1.3M in revenue recognized in Q3 2018 in connection with the termination of a license agreement, non-GAAP year-over-year revenue growth was 62%;

·Q3 product revenue was $10.7M versus prior year Q3 of $6.0M, an increase of 80%;

·Q3 service and other revenue was $4.2M versus prior year Q3 of $3.0M, an increase of 39%; and

·Q3 GAAP gross margin was 47.1% versus prior year Q3 of 52.8%; Q3 non-GAAP gross margin was 51.8% versus prior year Q3 of 46.2%, an increase of 560 bps.

YTD 2019 Financial Highlights

Key financial results for 2019 YTD are shown below:

· YTD revenue was $40.8M versus prior year YTD of $26.8M, an increase of 53%. On a non-GAAP basis, year-over-year revenue growth was 61%;

· YTD product revenue was $29.1M versus prior year YTD of $15.9M, an increase of 83%;

·YTD service and other revenue was $11.8M versus prior year YTD of $8.7M, an increase of 35%; and

·YTD gross margin was 48.9% versus prior year YTD of 47.6%, YTD non-GAAP gross margin was 50.7% versus prior year YTD of 45.0%, an increase of 570 bps.

For additional information on the non-GAAP financial measures included in this press release, please see "Use Non-GAAP Financial Measures" and "Reconciliation of GAAP to Non-GAAP Financial Measures" below.

Third Quarter 2019 Business Highlights

·We began shipments of the HD-X Analyzer ahead of our Q4 expectation, following a successful Early Access Program. Trade-ins for the HD-1 instrument are outpacing expectations.

·Our Nf-L assay was highlighted in a record 50 publications at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Stockholm, Sweden, continuing to demonstrate the growing momentum for clinical validity of this marker. Serum based Nf-L measurements were reported in major trials such as Novartis’ Phase III ASCLEPIOS trial, Roche’s results for Phase III OPERA I, II and ORATORIO trials, and Biogen’s data generated in collaboration with Siemens Healthineers using Quanterix/UmanDiagnostics Nf-L antibodies to adapt the Simoa assay onto a routine analyzer platform. We also hosted an extremely well-attended networking reception convening many leading opinion leaders in the field.

· We successfully raised $69M in gross proceeds through our follow-on offering, further strengthening our balance sheet with growth capital. Nearly $120M before expenses have been added to our balance sheet this year.

·We continued to strengthen our leadership team with a number of key hires. Dr. Tatiana Plavina joined us as vice president of Clinical BioMarker Strategy where she will focus on further advancing our industry by leading efforts on Nf-L and other biomarkers as clinically-meaningful tools for drug development and clinical care. Tatiana joins Quanterix after a successful 18-year career at Biogen, where she has been a biomarker leader, advancing clinical trials, developing a companion diagnostic test for Tysabri, and furthering the clinical relevance of serum Nf-L assay for drug development as a measure of neuronal health.

·Earlier this week, we entered into a licensing and supply arrangement with Siemens Healthineers for access to Quanterix’ proprietary Nf-L antibodies. We are pleased to have the opportunity to work with as formidable a partner as Siemens Healthineers to accelerate the availability of an Nf-L test for patients around the world.

·Quanterix was invited to present its disruptive approach to using minimally invasive biomarkers at a number of high-profile venues, including the SVB Leerink Healthcare CEO Summit, the Laguna Biotech CEO Forum, and the Healthcare CEO Summit in partnership with the Cleveland Clinic. We were also featured on "Nasdaq Spotlight" where we discussed our biomarker potential to enable precision health and participated in an interview with the author of the new book, "The First Cell: And the Human Cost of Pursuing Cancer to the Last," where we highlighted the potential of our newly released Simoa SP-X oncology technology in the battle against cancer. View Source

·Quanterix will be an exclusive Platinum Sponsor of the 2019 Powering Precision Health (PPH) Summit scheduled for November 19 in Barcelona, Spain, which continues to receive solid interest from opinion leaders and researchers from around the world. More than 40 speakers will be presenting their research across two full concurrent tracks in neurology and oncology.

Conference Call

In conjunction with this announcement, Quanterix Corporation will host a conference call on November 6 at 4:30 p.m. EST. Individuals interested in listening to the conference call may do so by dialing (833) 686-9351 for domestic callers, or (612) 979-9890 for international callers. Please reference the following conference ID: 5798993. A live webcast will also be available at: View Source and through the Investors section of the Company’s website,

On November 6, 2019 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported financial results for the third quarter ended September 30, 2019 (Press release, Puma Biotechnology, NOV 6, 2019, View Source [SID1234550487]). Unless otherwise stated, all comparisons are for the third quarter 2019 compared to the third quarter 2018.

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Product revenue, net consists entirely of sales revenue from NERLYNX, Puma’s first commercial product. Net NERLYNX revenue in the third quarter of 2019 was $53.5 million, compared to net NERLYNX revenue of $52.6 million in the third quarter of 2018. Net NERLYNX revenue in the first nine months of 2019 was $152.9 million, compared to net NERLYNX revenue of $139.4 million in the first nine months of 2018.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported a net loss of $16.9 million, or $0.44 per share, for the third quarter of 2019, compared to a net loss of $14.2 million, or $0.37 per share, for the third quarter of 2018. Net loss for the first nine months of 2019 was $64.4 million, or $1.67 per share, compared to $82.9 million, or $2.19 per share, for the first nine months of 2018.

Non-GAAP adjusted net loss was $4.7 million, or $0.12 per share, for the third quarter of 2019, compared to non-GAAP adjusted net income of $6.6 million, or $0.17 per basic share and $0.16 per diluted share, for the third quarter of 2018. Non-GAAP adjusted net loss for the first nine months of 2019 was $18.6 million, or $0.48 per share, compared to non-GAAP adjusted net loss of $14.5 million, or $0.38 per share, for the first nine months of 2018. Non-GAAP adjusted net loss excludes stock-based compensation expense. For a reconciliation of GAAP net loss to non-GAAP adjusted net loss and GAAP net loss per share to non-GAAP adjusted net loss per share, please see the financial tables at the end of this news release.

Net cash used in operating activities for the third quarter of 2019 was $7.3 million, compared to $7.3 million in the third quarter of 2018. Net cash provided by operating activities for the first nine months of 2019 was $20.8 million, compared to net cash used in operating activities of $31.2 million for the first nine months of 2018. At September 30, 2019, Puma had cash, cash equivalents and marketable securities of $110.4 million, compared to $165.4 million at December 31, 2018.

"In the third quarter of 2019 we were pleased to report that our supplemental New Drug Application for neratinib for the treatment of third-line HER2-positive metastatic breast cancer was accepted by the U.S. Food and Drug Administration," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "The FDA also granted Orphan Drug Designation for neratinib for the treatment of breast cancer patients with brain metastases during the quarter. In addition, we were pleased to report that NERLYNX was approved by Health Canada and ANMAT in Canada and Argentina, respectively, during the quarter."

Mr. Auerbach added, "We anticipate the following key milestones over the next 12 to 18 months: (i) reporting additional data from the Phase II CONTROL trial in the fourth quarter of 2019; (ii) reporting Phase II data from the SUMMIT basket trial of neratinib in HER2 nonamplified (HER2 negative) breast cancer patients with a HER2 mutation in the fourth quarter of 2019; (iii) receiving regulatory decisions for the extended adjuvant HER2-positive early stage breast cancer indication in additional countries; (iv) receiving a U.S. regulatory decision on neratinib in third-line HER2-positive metastatic breast cancer in the second quarter of 2020; and (v) conducting a pre-NDA meeting with the FDA to discuss accelerated approval of neratinib in HER2 mutated hormone receptor positive breast cancer and HER2 mutated cervical cancer in either the fourth quarter of 2020 or the first half of 2021."

Revenue

Total revenue consists of product revenue, net from sales of NERLYNX, Puma’s first commercial product, license revenue and royalty revenue. For the third quarter of 2019, total revenue was $56.4 million, of which $53.5 million was net product revenue, $2.8 million was license revenue received from Puma’s sub-licensees and $0.1 million was royalty revenue. This compares to total revenue of $62.6 million in the third quarter of 2018, of which $52.6 million was net product revenue and $10.0 million was license revenue received from one of Puma’s sub-licensees. For the first nine months of 2019, total revenue was $209.3 million, of which $152.9 million was net product revenue, $56.2 million was license revenue received from Puma’s sub-licensees and $0.2 million was royalty revenue. This compares to total revenue for the first nine months of 2018 of $179.9 million, of which $139.4 million was net product revenue and $40.5 million was license revenue.

Operating Costs and Expenses

Operating costs and expenses were $70.8 million for the third quarter of 2019, compared to $73.9 million for the third quarter of 2018. Operating costs and expenses for the first nine months of 2019 were $239.7 million, compared to $256.0 million for the first nine months of 2018.

Cost of Sales

Cost of sales was $9.4 million for the third quarter of 2019 and $26.7 million for the first nine months of 2019, compared to $9.0 million for the third quarter and $24.3 million for the first nine months of 2018.

Selling, General and Administrative Expenses

Selling, general and administrative expenses (SG&A) were $31.4 million for the third quarter of 2019, compared to $28.5 million for the third quarter of 2018. SG&A expenses for the first nine months of 2019 were $110.4 million, compared to $105.2 million for the first nine months of 2018. The $5.2 million year-to-date increase resulted primarily from increases of approximately $10.4 million for professional fees, such as legal fees and marketing and commercial support, and $0.6 million for office and banking expenses. These were partially offset by decreases of approximately $4.0 million in employee stock-based compensation expense, $0.9 million in payroll and payroll-related expenses, and $0.9 million in travel and meeting-related expenses.

Research and Development Expenses

Research and development (R&D) expenses were $30.0 million for the third quarter of 2019, compared to $36.4 million for the third quarter of 2018. R&D expenses for the first nine months of 2019 were $102.6 million, compared to $126.5 million for the first nine months of 2018. The $23.9 million year-to-date decrease resulted primarily from decreases of approximately $18.5 million in stock-based compensation expense, $4.4 million for internal R&D, primarily related to payroll and payroll-related expenses, $0.8 million in clinical trial expenses, and $0.2 million in consulting and contractor expenses related to clinical research and regulatory activities.

Total Other Income (Expenses)

Total other expenses were $2.5 million for the third quarter and $34.0 million for the first nine months of 2019, compared to total other expenses of $2.9 million for the third quarter and $6.8 million for the first nine months of 2018. The $27.2 million year-to-date increase includes approximately $16.4 million related to a March 2019 jury verdict against Puma, $8.1 million in loss on debt extinguishment related to fees paid in connection with our debt refinancing in the second quarter of 2019 and a $3.5 million increase in net interest expense. These amounts were offset by other immaterial fluctuations.

Conference Call

Puma Biotechnology will host a conference call to report its third quarter 2019 financial results and provide an update on the Company’s business and outlook at 1:30 p.m. PST/4:30 p.m. EST on Wednesday, Nov. 6, 2019. The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international) at least 10 minutes prior to the start of the call and referencing the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at www.pumabiotechnology.com. A replay of the call will be available approximately one hour after completion of the call and will be archived on the company’s website for 90 days.