On November 14, 2018 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to the development and delivery of high quality, cost-effective pharmaceutical products and innovative therapeutics to patients in the U.S., China and throughout the world, reported financial results for the third quarter and nine months ended September 30, 2018 and provided a review of recent accomplishments and anticipated upcoming milestones (Press release, CASI Pharmaceuticals, NOV 14, 2018, View Source [SID1234531333]).

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Ken K. Ren, Ph.D., CASI’s Chief Executive Officer, commented, "CASI made substantial progress in the third quarter. We continue working with relevant regulatory authorities and our strategic partners in the U.S. and in China to advance EVOMELA, MARQIBO, and ZEVALIN closer to the finish line in terms of CFDA approval and are making solid progress on all fronts. Our recent appointments of George Chi as Chief Financial Officer and Larry Zhang as President of CASI’s Beijing operations further underscore our commitment to bringing high-quality, cost-effective pharmaceutical products and innovative therapeutics to the market, and enables us to significantly ramp up our commercial preparatory activities. We recently acquired a U.S. FDA-approved ANDA for HBV from Laurus Labs Limited and continue to pursue opportunities to further augment our pipeline in conjunction with our broader mission."

Third Quarter and Recent Business Highlights

September Financing – During September, CASI received gross proceeds of approximately $37.5 million from a private placement of shares of common stock and warrants to purchase common stock to new and existing shareholders. The net proceeds will be used to support commercial activities, ongoing business development and for general working capital purposes.

CASI Pharmaceuticals, Inc. / 9620 Medical Center Drive / Suite 300 / Rockville, MD 20850

Phone 240.864.2600 / Fax 301.315.2437

New Executive Appointments: Chief Financial Officer and President of CASI China – On September 28, CASI announced the appointment of George Chi as Chief Financial Officer to oversee the company’s expanding fiduciary responsibilities as it gears up for commercialization in China and to lead the company’s financial strategy and affairs. On October 2, the company announced the appointment of Larry Zhang as President of CASI (Beijing) Pharmaceuticals Co., Ltd., the China operating subsidiary of CASI Pharmaceuticals, Inc. Mr. Zhang is overseeing operations in China as CASI prepares for commercial activities.

Acquired U.S. FDA-approved abbreviated new drug application (ANDA) from Laurus Labs Limited – On October 23, CASI announced that it had acquired tenofovir disoproxil fumarate (TDF), indicated for the treatment of hepatitis B virus (HBV), from Laurus Labs Limited. The aggregate purchase price for the ANDA was $3 million, with an upfront payment of $700,000 and $2.3 million to be paid upon completion of certain milestones. The acquisition of TDF is consistent with the company’s mission to commercialize U.S. FDA approved drugs in China.

China FDA (CFDA) import drug registration priority review of EVOMELA in progress – CASI has received a series of standard questions from the CFDA related to EVOMELA drug product production, which usually reflect the final stage of CFDA assessment before approval based on the Import Drug Approval registration pathway. CASI is working with Spectrum Pharmaceuticals, and its vendors, from whom EVOMELA is in-licensed to address the questions and submit the requested documents.

Preparation continues for EVOMELA’s commercial launch in China – CASI has established a core in-house marketing and sales team led by Thomas Zhang, who possesses a 20-year track record of commercializing oncology drugs in China for Roche and Johnson & Johnson.

CFDA review in progress for MARQIBO and ZEVALIN – CASI continues to make good progress with the CFDA toward advancing MARQIBO’s and ZEVALIN’s import drug clinical trial applications. The ZEVALIN antibody kit and the radioactive Yttrium-90 component of the application require separate submissions; both are currently under technical review by the Center for Drug Evaluation of the CFDA and the quality confirmatory testing by National Institute for Food and Drug Control (NIFDC) of the CFDA as part of the regulatory review process.

Third Quarter and First Nine Months 2018 Financial Results

Cash Position: As of September 30, CASI had cash and cash equivalents of $98.9 million compared to $66.2 million as of June 30, 2018. This increase primarily reflects the gross proceeds of $37.5 million received in September 2018 related to CASI’s $48.5 million private placement announced in September 2018, partially offset by costs related to operating expenses during the quarter.

R&D Expenses: Research and development (R&D) expenses for the three and nine months ended September 30, 2018, were $1.8 million and $5.2 million, respectively, compared to $1.0 million and $3.7 million for the same periods in 2017. The increase in R&D expenses primarily reflects personnel costs associated with the technology transfer activities and regulatory support services associated with the recently acquired ANDA portfolio, as well as increased costs associated with the Company’s internal preclinical activities in China.

G&A Expenses: General and administrative (G&A) expenses for the three and nine months ended September 30, 2018, were $6.9 million and $12.3 million, respectively, compared to $0.6 million and $2.0 million for the same periods in 2017. The increase in G&A over the prior year is primarily attributed to non-cash stock-based compensation expense for the stock options issued to the Company’s Executive Chairman and an increase in salary, benefits and recruitment expense in China, largely related to sales and marketing efforts to prepare for the anticipated launch of the Company’s first commercial product in China, as well as other G&A functions. There were also increased costs associated with business development related to exploratory acquisition activities, investor and public relations activities, and an increase in legal and other professional services fees during the 2018 period. G&A expenses include non-cash stock-based compensation of $1.6 million and $3.3 million for the three and nine months ended September 30, 2018, respectively, compared to $0.1 million and $0.3 million in the respective periods in 2017.

Net Loss: The Company reported a net loss attributable to common shareholders for the three and nine months ended September 30, 2018 of ($8.8) million, or ($0.10) per share, and ($18.2) million, or ($0.22) per share, respectively, compared to ($1.6) million, or ($0.03) per share, and ($5.7) million, or ($0.10) per share for the same periods in 2017. The larger net loss for both periods is primarily due to the non-cash stock-based compensation expense for stock options issued to the Company’s Executive Chairman, costs associated with the technology transfer activities and regulatory support for our ANDA portfolio, the write-off of approximately $0.7 million in January 2018 due to acquired in-process R&D primarily related to ANDAs not approved by the FDA, and increased costs associated with G&A functions, including employment costs for sales and marketing efforts, increased business development related to exploratory acquisition efforts and investor relations activities, higher professional service fees, and administrative fees associated with the Company’s September 2018 financing.

Further information regarding the Company, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2018, can be found at www.casipharmaceuticals.com.

On November 14, 2018 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation oncology therapeutics, reported its financial results for the third quarter ended September 30, 2018 (Press release, Sutro Biopharma, NOV 14, 2018, View Source [SID1234531319]).

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"This has been an outstanding third quarter for Sutro. We have completed our initial public offering and achieved multiple milestones in the development of our own clinical programs for treatment of multiple myeloma and ovarian cancer," said Bill Newell, Sutro’s Chief Executive Officer. "We look forward to working with our newest partners and collaborators as the Sutro team continues to execute at a high level to advance our vision of transforming the lives of patients."

Business Highlights and Recent Developments

STRO-001 Clinical Program

STRO-001 granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of multiple myeloma.
The Leukemia & Lymphoma Society (LLS) agreed to contribute clinical development funding for STRO-001 through its Therapy Acceleration Program, which forges collaborations with biotechnology companies to help bring innovative therapies to patients faster.
Potential first-in-class antibody-drug conjugate (ADC) directed against CD74 is currently being studied in a Phase 1 clinical trial enrolling separate dose escalation cohorts for myeloma and B-cell lymphoma.
STRO-002 Clinical Program

The FDA has concluded their 30-day review of Sutro’s Investigational New Drug (IND) application for STRO-002, a targeted antibody-drug conjugate directed against folate receptor-alpha. Sutro expects to commence a Phase 1 clinical trial focused on ovarian and endometrial cancers in early 2019.
Corporate Highlights

Collaboration and licensing agreement signed with Merck to discover and develop novel immune-modulating therapies for cancer and autoimmune disorders.
Sutro is primarily responsible for preclinical research and Merck will obtain exclusive worldwide rights to therapeutic candidates derived from the collaboration.
Sutro received from Merck an upfront payment of $60 million, a $20 million investment in its Series E preferred stock, and $10 million investment in a private placement of common stock concurrent with the IPO.
Sutro is eligible for milestone payments totaling up to $1.6 billion, assuming the development and sale of all therapeutic candidates and all possible indications identified under the collaboration, as well as tiered royalties ranging from mid-single digit to low teen percentages on worldwide sales of commercial products that may result from the collaboration.
The initial public offering (IPO) that closed on October 1, 2018, provided Sutro with gross proceeds of $85.0 million, before deducting underwriting discounts and commissions and offering expenses. Additionally, Sutro received proceeds of $10.0 million from Merck in a private placement of common stock concurrent with the IPO.
Appointment of Stephen Worsley as Chief Business Officer and Linda Fitzpatrick as Chief People and Communications Officer.
Third Quarter 2018 Financial Highlights

Cash, Cash Equivalents and Marketable Securities

As of September 30, 2018, Sutro had cash, cash equivalents and marketable securities of $123.0 million.

In October 2018, Sutro announced the closing of its IPO of 5,667,000 shares of its common stock at a price of $15.00 per share. The gross proceeds to Sutro from the IPO, before deducting underwriting discounts and commissions and offering expenses, were $85.0 million. In addition to the IPO, Sutro concurrently sold in a private placement to Merck Sharp & Dohme Corp. (Merck) additional shares of common stock at the IPO offering price for gross proceeds of $10.0 million. Proceeds from the IPO and the concurrent private placement are not reflected in Sutro’s September 30, 2018 balance sheet.

Revenue

Revenue was $7.8 million for the third quarter of 2018, which included collaboration revenue of $6.9 million recognized primarily from Merck, Celgene and EMD Serono, in addition to other revenue of $0.9 million. During the third quarter of 2018, Sutro began recording revenue from Merck primarily from the $60.0 million upfront payment received by Sutro under the July 2018 collaboration and licensing agreement, for which revenue is being recognized ratably over an approximate four-year period. Future collaboration revenue from Merck, Celgene and EMD Serono, and from any future collaboration partners, will fluctuate as a result of the timing and amount of upfront, milestones and other collaboration agreement payments.

Operating Expenses

Total operating expenses for the third quarter of 2018 were $18.0 million, comprised of research and development expenses of $12.6 million and general and administrative expenses of $5.4 million. Total operating expenses for the quarter included non-cash stock-based compensation expense of $0.3 million and depreciation and amortization expense of $1.1 million. In future quarters, Sutro expects to incur additional general and administrative expenses as it operates as a public company following its IPO that closed on October 1, 2018.

Net Loss Per Share Calculation

The financial statements as of September 30, 2018, including share and per share amounts, do not give effect to the IPO, or the conversion of the redeemable convertible preferred stock, as the IPO and such conversions were completed on October 1, 2018. Relatedly, the weighted-average shares used in calculating net loss per share for the third quarter of 2018 include only common stock outstanding prior to the IPO.

On November 14, 2018 Agendia, Inc., a world leader in precision oncology, reported new data from the I-SPY 2 study, presented at the European Organization for Research and Treatment of Cancer (EORTC), the National Cancer Institute (NCI) and the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Symposium (Press release, Agendia, NOV 14, 2018, View Source [SID1234531318]). The two presentations demonstrate both the prognostic, and the predictive role of the MammaPrint 70-Gene Breast Cancer Risk of Recurrence and BluePrint 80-Gene Molecular Subtyping tests in determining which patients are likely to respond to therapies. Dr. Laura van’t Veer, chief research officer and co-founder at Agendia, and Professor of Laboratory Medicine at the University California San Francisco, will present the results at the 30th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium at 15:00 GMT on Wednesday, Nov. 14, 2018.

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MammaPrint High1/High2 risk class as a pre-specified biomarker of response to nine different targeted agents plus standard neoadjuvant therapy for ~1000 breast cancer patients in the I-SPY 2 TRIAL (Abstract 2)1

A new analysis from the I-SPY 2 trial showed that a subgroup of "Ultra-High Risk" patients identified by MammaPrint respond better to certain targeted therapies and treatment combinations. Patients were classified as either MammaPrint High Risk (MP1), indicating less aggressive disease, or MammaPrint Ultra-High Risk (MP2), indicating more aggressive disease. Nearly 50 percent of patients were classified as MP2 and had higher rates of pathological complete response (pCR) compared to MP1 patients.

In addition, MP2 patients had a higher chance of achieving pCR if they received veliparib/carboplatin, neratinib, ganitumab, TDM1/pertuzumab or pembrolizumab in addition to the standard paclitaxel treatment alone or in combination with trastuzumab. Together, these findings support the use of the MammaPrint High Risk or Ultra-High Risk result as a predictive biomarker of treatment response.

BluePrint basal subtype predicts neoadjuvant therapy response in ~400 HR+HER2- patients across 8 arms in the I-SPY 2 TRIAL (Abstract 3)2

A second analysis of the I-SPY 2 trial evaluated neoadjuvant chemotherapy response in different subgroups of patients with HR+/HER2- disease. Using the BluePrint Molecular Subtyping test, patients were classified as having either basal, luminal or HER2 subtypes. Patients with the basal subtype were four times more likely to achieve pCR with neoadjuvant therapy than patients with the luminal subtype, and this association was independent of the type of treatment they received. Additionally, more than three-quarters of patients with the HR+/HER2- basal subtype of cancer were classified as having MP2 Ultra-High Risk disease, suggesting that genetic and molecular risk signatures can be used to predict treatment response in similar subgroups of patients.

Dr. Laura van ‘t Veer, Chief Research Officer and Co-founder at Agendia said:

"The results presented at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium demonstrate that MammaPrint is not just a prognostic test, it is also a predictive test. When used in conjunction with BluePrint, it can stratify patients into different subgroups to help identify which are more likely to respond to new treatments or to neoadjuvant chemotherapy and which are not likely to respond and should be given an alternative treatment. We need to further investigate the clinical implications, but this is an important milestone with significant value for women with breast cancer."

Dr. William Audeh, Chief Medical Officer at Agendia said:

"The new studies stemming from the I-SPY 2 trial are very encouraging and highlight the continuing and constantly expanding utility of MammaPrint and BluePrint to identify which patients will respond to specific treatments based on the genomic signatures of their tumors. In discovering the MammaPrint signature with her colleague Dr. Rene Bernards, Dr. van ‘t Veer harnessed the power of genomics to provide a platform capable of yielding continuous new discoveries to further understand and personalize the treatment of breast cancer. As the landmark I-SPY 2 trial further evolves, we anticipate future findings that will continue to bolster the value of precision oncology."

MammaPrint High1/High2 risk class as a pre-specified biomarker of response to nine different targeted agents plus standard neoadjuvant therapy for ~ 1000 breast cancer patients in the I-SPY 2 TRIAL. Poster presented at EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper). November 2018; Dublin, Ireland.
BluePrint basal subtype predicts neoadjuvant therapy response in ~400 HR+HER2- patients across 8 arms in the I-SPY 2 TRIAL. Poster presented at EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper). November 2018; Dublin, Ireland.
About MammaPrint

MammaPrint is an in vitro diagnostic medical device, performed as a testing service in a central laboratory, using the 70-gene expression profile of breast cancer tissue samples to assess a patient’s risk for distant metastasis. The device is FDA-cleared and CE-marked, enabling use in the European Union. MammaPrint is indicated for use by physicians as a prognostic marker only, along with other clinical-pathological factors. It is not intended to determine the outcome of disease, nor to suggest or infer an individual patient’s response to therapy. MammaPrint is the only test of its kind recommended for lymph node-negative and lymph node-positive patients by both the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and National Comprehensive Cancer Network (NCCN). The test is also recommended by many other national and international clinical practice guidelines.

About BluePrint

BluePrint is an 80-gene complementary test provided with MammaPrint which allows functional molecular subtyping of a breast cancer sample into three distinct subtypes: Luminal-type, HER2-type and Basal-type, each with marked differences in long-term outcome and response to neoadjuvant chemotherapy.

About I-SPY 2

I-SPY 2 is an interventional, randomized neoadjuvant Phase II clinical trial that is evaluating the efficacy of new targeted drug agents in combination with standard chemotherapy compared to standard therapy alone. The goal of the trial is to identify more treatment regimens for different subsets of breast cancer patients based on the molecular characteristics of their tumors and by learning about which early indicators of response are predictors of treatment success. A MammaPrint High Risk result is a prerequisite for patients included in the trial.

On November 14, 2018 Personalis, Inc., a leader in advanced genomics for precision oncology, reported that they are scheduled to present at the upcoming NeoAG Summit in Boston, MA on Thursday, November 15, 2018 at 4 PM ET (Press release, Personalis, NOV 14, 2018, View Source [SID1234531317]).

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The presentation, entitled "ImmunoID NeXT Platform: Improving Neoantigen Prediction, TME Assessment, and ctDNA Detection for Vaccine Development," will introduce Personalis’ new ImmunoID NeXT Platform and discuss how it facilitates highly accurate neoantigen identification, optimal MHC-binding prediction and ranking, and the assessment of the tumor microenvironment and tumor escape mechanisms that may impact response to personalized therapeutics.

ImmunoID NeXT is the first and only platform to provide comprehensive analysis of both a tumor and its microenvironment from a single sample. The platform can be used to investigate the key tumor- and immune-related areas of cancer biology; consolidating multiple oncology biomarker assays into one. This maximizes the biological information that can be generated from a precious tumor specimen.

The presentation will be delivered by Sean Boyle, PhD; Director, Bioinformatics Applications.

On November 14, 2018 The Janssen Pharmaceutical Companies of Johnson & Johnson reported the submission of two Type II variation applications to the European Medicines Agency (EMA) seeking approval for the expanded use of IMBRUVICA (ibrutinib) (Press release, Johnson & Johnson, NOV 14, 2018, View Source [SID1234531316]). One application seeks to include use of ibrutinib in combination with obinutuzumab in previously untreated adults with chronic lymphocytic leukaemia (CLL) and to add long-term follow-up data from the existing label studies RESONATETM (PCYC-1112) and RESONATETM-2 (PCYC-1115). The second is for use of ibrutinib plus rituximab for the treatment of previously untreated and relapsed/refractory adults with Waldenström’s macroglobulinemia (WM).

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"Today’s news brings us one step closer to potentially offering ibrutinib in new combinations for patients where unmet needs still persist," said Dr. Catherine Taylor, Haematology Therapy Area Lead, Europe, Middle East and Africa (EMEA), Janssen-Cilag Limited. "Ibrutinib continues to demonstrate clinical benefit over the long term for a broad group of patients living with blood cancer, and we look forward to working with relevant authorities to secure approval of these new combinations."

Ibrutinib, a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, is jointly developed and commercialised by Janssen Biotech, Inc., and Pharmacyclics LLC, an AbbVie company.

The CLL submission is supported by positive results from the Phase 3 iLLUMINATE (PCYC-1130) study which investigated ibrutinib in combination with obinutuzumab versus chlorambucil plus obinutuzumab in patients with newly diagnosed CLL.1 Study findings from iLLUMINATE will also be featured as an oral presentation (abstract #691), whilst further analysis of RESONATETM and RESONATETM-2 results in comparison with real-world evidence databases (abstract #4427) will be included at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place in San Diego next month.1,2 A supplemental New Drug Application (sNDA) which was also recently submitted to the U.S. Food and Drug Administration (FDA) received Priority Review.

In WM, the submission is supported by data from the Phase 3 iNNOVATE (PCYC-1127) study evaluating ibrutinib in combination with rituximab, versus rituximab with placebo, in patients with previously untreated and relapsed/refractory WM.3 Follow-up efficacy and safety findings from the iNNOVATE study will also be presented at ASH (Free ASH Whitepaper) 2018 (abstract #149).4 In August 2018, the FDA approved ibrutinib in combination with rituximab for the treatment of WM based on the data from iNNOVATE.5

Additional information about both studies can be found at www.ClinicalTrials.gov (NCT02264574 and NCT02165397).6,7

#ENDS#

About ibrutinib

Ibrutinib is a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, which works by forming a strong covalent bond with BTK to block the transmission of cell survival signals within the malignant B-cells.8 By blocking this BTK protein, ibrutinib helps kill and reduce the number of cancer cells, thereby delaying progression of the cancer.9

Ibrutinib is currently approved in Europe for the following uses:10

Chronic lymphocytic leukaemia (CLL): As a single agent for the treatment of adult patients with previously untreated CLL, and as a single agent or in combination with bendamustine and rituximab (BR) for the treatment of adult patients with CLL who have received at least one prior therapy.
Mantle cell lymphoma (MCL): Adult patients with relapsed or refractory mantle cell MCL.
Waldenström’s macroglobulinemia (WM): Adult patients who have received at least one prior therapy or in first-line treatment for patients unsuitable for chemo-immunotherapy.
The most common adverse reactions seen with ibrutinib include diarrhoea, neutropenia, haemorrhage (e.g., bruising), musculoskeletal pain, nausea, rash, and pyrexia.10

For a full list of side effects and information on dosage and administration, contraindications and other precautions when using ibrutinib please refer to the Summary of Product Characteristics for further information.

About CLL

CLL is typically a slow-growing blood cancer of the white blood cells.11 The overall incidence of CLL in Europe is approximately 4.92 cases per 100,000 persons per year with rates amongst men and women approximately 5.87 and 4.01 cases per 100,000 persons per year, respectively.12 CLL is predominantly a disease of the elderly, with a median age of 72 years at diagnosis.13

CLL is a chronic disease; median overall survival ranges between 18 months and more than 10 years, according to the stage of disease.14 The disease eventually progresses in the majority of patients, and patients are faced with fewer treatment options with each relapse. Patients are often prescribed multiple lines of therapy as they relapse or become resistant to treatments.

About Waldenström’s macroglobulinemia

Waldenström’s macroglobulinemia (WM) is a rare form of non-Hodgkin’s lymphoma (NHL).15 It causes overproduction of a protein called monoclonal immunoglobulin M (IgM) antibody, which causes a thickening of the blood.16 Incidence rates among men and women in Europe are approximately 7.3 and 4.2 per million persons, respectively.17 The causes of WM are unknown, with it typically affecting older adults and being slightly more common in men than women.15,17