1stOncology™: Cancer Intelligence Service – Page 14443 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Prometic Reports Third Quarter 2018 Financial Results and Highlights

On November 14, 2018 Prometic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (Prometic or the Corporation) reported today its unaudited financial results for the third quarter ended September 30, 2018 (Press release, ProMetic Life Sciences, NOV 14, 2018, View Source [SID1234531350]).

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!

"Several initiatives that we have been pursuing during the past quarter should bear fruit in the coming weeks and months," said Pierre Laurin, Prometic’s President and Chief Executive Officer. "We have implemented cost-control measures to reduce our cash use while at the same time have made significant progress to advance our two lead drug candidates, Ryplazim (plasminogen) and PBI-4050. As previously stated, our current business plan calls for a significant reduction in R&D expenditures of up to $30 million in 2019 as compared to this year’s budget. Our primary objective remains to close the gap between the fundamental enterprise value we have built and our current market valuation by strengthening our financial position through the closing of commercial partnerships and equity-related initiatives."

Commenting on the third quarter 2018 financial results, Bruce Pritchard, Prometic’s Chief Operating Officer and Chief Financial Officer, said, "We are ahead of target with the financial guidance provided during the AGM in May 2018 and our last few conference calls. We have effectively implemented cost control measures as evidenced by the trending quarterly decrease in R&D, Administration and Sales & Marketing expenses as well as decreases in net loss and cash flows used in operating activities. Cash used in operations year-to-date was $57 M compared to $95 M for the same period in 2017".

Small Molecule Therapeutics Highlights

PBI-4050 – Received a Rare Pediatric Disease designation from the US Food and Drug Administration for the treatment of Alström syndrome
PBI-4050 – Published a paper further elucidating the mechanism of action of its lead drug candidate, PBI-4050, on liver fibrosis in the Journal of Pharmacology and Experimental Therapeutics. The paper entitled "PBI-4050 reduces stellate cell activation and liver fibrosis through modulation of intracellular ATP levels and LKB1-AMPK-mTOR pathway" details the antifibrotic signaling pathway modulated by PBI-4050.
PBI-4050 – Hosted a Key Opinion Leader meeting in New York on PBI-4050 as a novel treatment for Alström syndrome and non-alcoholic steatohepatitis (NASH).
Plasma-Derived Therapeutics Highlights

RyplazimTM (Plasminogen) – Completed a Type C meeting in which the FDA agreed with the Company’s proposed action plan for the implementation of additional analytical assays and in-process controls related to the RyplazimTM (plasminogen) manufacturing process. As a result of the feedback received during the Type C meeting, Prometic is finalizing the process performance qualification (PPQ) protocols in anticipation of commencing the manufacturing of additional RyplazimTM (plasminogen) conformance lots.

Subsequent Events to Third Quarter 2018

Closed a deal with Structured Alpha LP (SALP), an affiliate of Thomvest Asset Management Inc., to extend the maturity dates of the USD $80 million (CAD $100 million) line of credit and the Original Issue Discount Notes to September 2024.
2018 Third Quarter Financial Results

Revenues
Total revenues for the third quarter ended September 30, 2018 were $12.3 million and $36.8 million for the nine months ended September 30, 2018. Revenues from the sale of goods, representing most of the 2018 revenues to date, were $35.3 million during the first nine months ended September 30, 2018 compared to $11 million during the corresponding 2017 period. The $24.3 million increase for 2018 is mainly due to $19.7 million in sales of normal source plasma which occurred in the second and third quarters of 2018 following a change in the production forecast due to the delay of the BLA approval for RyplazimTM (plasminogen). The remainder of the increase of $4.6 million for the nine month period is due to an increase in third party sales in the bioseparation segment. 2018 bioseparation sales are expected to exceed $21 million, which would represent a 30% increase compared to 2017 bioseparation revenues. A comparable level of revenue growth for 2019 is anticipated and is mainly due to the expansion of manufacturing activities by existing clients who utilize Prometic’s products in their production processes, the adoption of products by new clients, the introduction of new products and the continuing expansion of the market for bioseparation products.

Cost of sales and other production expenses
Cost of sales and other production expenses were $9.2 million for the third quarter ended September 30, 2018 compared to $3.8 million for the corresponding period in 2017, representing an increase of $5.5 million. Cost of sales and other production expenses were $30.4 million during the nine months ended September 30, 2018 compared to $7.7 million for the corresponding period in 2017, representing an increase of $22.7 million. The increase was due primarily to the cost of the plasma inventory sold.

Research and Development (R&D)
Total R&D expenses were $24.1 million for the third quarter ended September 30, 2018 compared to $23.3 million for the third quarter ended September 30, 2017. Total R&D expenses were $70.5 million for the nine months ended September 30, 2018 compared to $72.2 million for the corresponding period in 2017, representing a decrease of $1.7 million. The completion of the pivotal phase 3 clinical programs for IVIG and for Ryplazim (plasminogen) and termination of non core preclinical and clinical programs will translate into a significant R&D cost reduction in 2019 compared to 2018.

Administration, Sales & Marketing
Administration, selling and marketing expenses were $6.2 million for the third quarter ended September 30, 2018 compared to $7.7 million for the third quarter ended September 30, 2017. The $1.4 million decrease was due to a reduction in consulting fees and employee compensation expenses. Administration, selling and marketing expenses declined slightly at $20.9 million during the nine months ended September 30, 2018 compared to $22.7 million for the corresponding period in 2017.

Finance Costs
Finance costs were $5.9 million for the third quarter ended September 30, 2018 compared to $2.1 million during the corresponding period of 2017, representing an increase of $3.8 million. Finance costs were $15.5 million for the nine months ended September 30, 2018 compared to $5.3 million during the corresponding period of 2017, representing an increase of $10.2 million. This increase reflects higher debt levels during the nine months ended September 30, 2018 compared to the same period of 2017.

Net Loss
Prometic incurred a net loss of $28.9 million for the third quarter ended September 30, 2018 compared to a net loss of $17.8 million for the third quarter ended September 30, 2017. Prometic incurred a net loss of $96.6 million for the nine months ended September 30, 2018 compared to a net loss of $78.4 million for the corresponding period of 2017. The main reason for the increase in the net loss is that the results for the quarter and the nine months ending September 30, 2017 included $19.7 million in milestone and licensing revenues related to the licensing agreement signed with Jiangsu Renshou Pharmaceutical Co, Ltd.

With the delay of the anticipated launch of its most advanced product, RyplazimTM (plasminogen), the Corporation had to finance its R&D activities via various sources. To date, the Corporation has financed its activities through the sale of products in the bioseparations segment, collaboration arrangements and licensing arrangements, the issuance of debt and equity, operational restructuring as well as investment tax credits. Prometic is currently actively involved in negotiating both equity and equity-linked financing initiatives and continues to be in dialogue with potential licensing partners. Although the Corporation believes that it will be able to obtain the necessary funding as in the past, there can be no assurance of the success of these plans.

Conference Call Information

Prometic will host a conference call at 11:00 am (ET) on Thursday November 15, 2018. The telephone numbers to access the conference call are (647) 427-7450 and 1-888-231-8191 (toll-free). A replay of the call will be available as of Thursday November 15, 2018 at 2:00 pm. The numbers to access the replay are 1-416-849-0833 and 1-855-859-2056 (passcode: 1190238). A live audio webcast of the conference call, with slides, will be available through the following: View Source

Additional Information in Respect to the Third Quarter Ended September 30, 2018

Prometic’s MD&A and condensed interim consolidated financial statements for the quarter ended September 30, 2018 will be filed on SEDAR (View Source) and will be available on the Company’s website at www.prometic.com.

Replimune Reports Financial Results for the Second Fiscal Quarter, Ended September 30, and Provides Development and Corporate Update

On November 14, 2018 Replimune Group Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immunotherapies derived from its Immulytic platform, reported financial results for its second fiscal quarter ended September 30, 2018, and provided an update on its business (Press release, Replimune, NOV 14, 2018, View Source [SID1234531348]).

"All of our programs are progressing to track within the timelines outlined to investors during our July 2018 initial public offering" said Robert Coffin, Ph.D., co-founder and CEO of Replimune. "We were pleased to receive FDA acceptance of our IND for RP1 this past quarter which allows us to expand enrollment of our Phase 1/2 trial beyond the U.K. and into the U.S. by year-end 2018. In addition, we continue to make progress developing both RP2 and RP3 which will expand the potential utility of our platform beyond the current indications and into most solid tumors."

Recent Business Highlights and Upcoming Events
Investigational New Drug (IND) application for RP1 accepted by the U.S. Food and Drug Administration (FDA). RP1 is Replimune’s first Immulytic product candidate to enter the clinic and is based on a proprietary new strain of herpes simplex virus engineered to maximize tumor killing potency intended to result in highly immunogenic cell death and activation of a systemic anti-tumor immune response. The accepted IND allows Replimune to start enrolling patients in the Company’s ongoing Phase 1/2 clinical trial in the U.S., which is expected to occur by year-end 2018.
Continued progress with the Phase 1/2 study of RP1 in multiple solid tumors. Replimune’s Phase 1/2 clinical trial with RP1 is currently ongoing in the U.K. In the first part of the clinical trial Replimune is initially testing RP1 alone and then in combination with nivolumab for safety and biological activity in patients with advanced, heavily pre-treated solid tumors. The combination phase of the first part of the clinical trial is expected to be underway in the U.S. and the U.K. by the year end. The second part of the Phase 1/2 clinical trial is on track to begin in the first half of 2019, and will study the safety and efficacy of RP1 in combination with nivolumab in approximately 120 patients with metastatic melanoma, metastatic bladder cancer, microsatellite instability high cancer, and non-melanoma skin cancers under Replimune’s collaboration agreement with Bristol-Myers Squibb.
Phase 2 clinical trial of RP1 in combination with cemiplimab remains on track to initiate in the first half of 2019. This Phase 2 trial is intended to be a randomized, controlled clinical trial of RP1 in combination with the anti-PD-1 antibody cemiplimab compared to cemiplimab alone, in approximately 240 patients with cutaneous squamous cell carcinoma (CSCC). CSCC is the highest mortality skin cancer after melanoma and accounts for 4,000 to 9,000 annual deaths in the U.S. The primary objective of the Phase 2

clinical trial is intended to assess the response rate of the combination therapy compared to treatment with anti-PD-1 therapy alone, with key secondary endpoints expected to include the rate of complete response and the duration of response. This clinical trial is the first to be conducted under our collaboration with Regeneron, and has been designed as a potentially registration-directed clinical trial.

Build out of Replimune’s own manufacturing facility to support late-stage development and commercialization is on track and expected to be operational first half of 2020. In July 2018, Replimune signed a lease for a 63,000-square-foot facility in Framingham, MA where the Company intends to establish world-class multi-product manufacturing capabilities for its Immulytic product candidates. The facility is currently being built out and expected to be operational in the first half of 2020.

IND filing for RP2 remains on track for the first half of 2019. The Company expects to file an IND during the first half of 2019 with the FDA in the U.S., and/or a Clinical Trial Authorisation (CTA) with the Medicine and Healthcare Products Regulatory Agency (MHRA) in the U.K., in order to initiate a Phase 1 trial of RP2 and RP2 in combination with anti-PD1 therapy in mixed solid tumors. RP2 is a version of RP1 that, in addition to expressing a fusogenic protein and GM-CSF, also expresses a genetically encoded anti-CTLA-4 antibody intended to block the inhibition of the immune response otherwise caused by CTLA-4.

·RP3 product candidate to be finalized by year-end 2018. RP3 is the Company’s third oncolytic immunotherapy and includes the properties of both RP1 and RP2 while also expressing ligands for the various immune co-stimulatory pathways responsible for T-cell proliferation and/or activation. The precise payload of immune-activating ligands for RP3 is expected to be finalized by the end of 2018, and initiation of the Phase 1 clinical trial with RP3 remains on track for the first half of 2020.

Financial Highlights

Replimune reported a net loss of $6.5 million for the quarter ended September 30, 2018 compared with $4.7 million for same period in the prior year. The increase in net loss for the year was due to increased research and development expenses as well as expenses related to Replimune’s initial public offering (IPO).

Research and development expenses for the quarter ended September 30, 2018 were $5.0 million compared with $3.1 million for same period in the prior year. The increase in research and development expenses was primarily driven by additional costs related to Replimune’s preclinical and clinical development activities for its pipeline, as well as increased salary and related benefits costs due to the increase in employee headcount from 28 on September 30, 2017 to 43 on September 30, 2018.

General and administrative expenses were $2.1 million for the quarter ended September 30, 2018 compared with $1.1 million for same period in the prior year. The increase in general and administrative expenses was primarily due to an increase in legal and accounting fees related to the Company’s IPO, the increase in employee headcount and the impact of stock-based compensation in 2018.

Replimune ended the quarter with $147.9 million in cash, cash equivalents and short-term investments, compared with $61.6 million as of March 31, 2018. The increase reflects net proceeds received of $103.3 million in connection with its IPO.

Based on its current operating plan, Replimune expects that its current cash, cash equivalents and short-term investments will enable it to fund its operating expenses and capital expenditure requirements into the second half of 2021.

CASI PHARMACEUTICALS ANNOUNCES THIRD QUARTER AND FIRST NINE MONTHS 2018 FINANCIAL AND BUSINESS RESULTS

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]).

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.

Sutro Biopharma Reports Third Quarter 2018 Financial Results

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]).

"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.

Latest Results from the I-SPY 2 Trial at the EORTC-NCI-AACR Symposium Demonstrate Ability of MammaPrint® and BluePrint® to Predict Treatment Response in Breast Cancer Patients

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.

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.