On November 7, 2018 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, reported that an overview of the company’s business strategy and commercial and development-stage programs will be given at the Jefferies 2018 London Healthcare Conference being held in London (Press release, Spectrum Pharmaceuticals, NOV 7, 2018, http://investor.sppirx.com/news-releases/news-release-details/spectrum-pharmaceuticals-present-corporate-update-jefferies-2 [SID1234530969]). The company presentation is on Wednesday, November 14, 2018, at 3:20 PM GMT.

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A live webcast of Spectrum’s presentation will be available at www.sppirx.com.

On November 7, 2018 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported financial results for the third quarter ended September 30, 2018 (Press release, Compugen, NOV 7, 2018, View Source [SID1234530995]).

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"The last few months have been highly productive for Compugen, with strong execution marked by multiple key accomplishments. In September, we dosed the first patient in our Phase 1 COM701 study, which continues to progress as planned. Shortly thereafter, we signed a clinical collaboration agreement with Bristol-Myers Squibb, providing for the supply of Opdivo for the combination arms of the trial, as well as establishing the opportunity to accelerate the clinical evaluation of COM701 through other combination studies," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "With Bayer’s first patient dosing in their Phase 1 study of BAY 1905254 this quarter, there are now two ongoing clinical trials addressing novel targets we discovered through computer prediction; further evidence of the power and value of our computational discovery platform."

"Our preclinical data demonstrate that PVRIG and TIGIT are the primary inhibitory components of the foundational immuno-oncology DNAM axis, and that PVRIG is a key missing piece for cancer immunotherapy approaches that involve solely targeting the TIGIT pathway in this axis. Our research demonstrates that targeting PVRIG will be necessary to maximize the anti-tumor activity of TIGIT inhibitors, with or without PD-1 inhibitors, in various cancer types and patient populations. This is supported by initial clinical data released by others that show encouraging but modest effects of anti-TIGIT antibodies in Phase 1 clinical trials."

"As the only anti-PVRIG drug candidate currently available for clinical testing, COM701 stands out in the crowded field of immuno-oncology and offers a compelling opportunity to counteract the inhibition of the DNAM axis and potentially address the significant unmet medical need of cancer patients who are relapsed or refractory to other immunotherapies. Moreover, this program illustrates our differentiated approach to drug discovery and development; one that is guided by three principals – a focus on new pathways aimed at addressing a significant unmet need, a science-driven approach to select optimal drug combinations; and a robust rationale and strategy for patient selection based on a deep scientific understanding of the new pathways."

"We are confident that this differentiated approach will continue to produce high-potential, first-in-class therapeutic candidates in our earlier stage immuno-oncology programs," Dr. Cohen-Dayag concluded.

Recent highlights:
·
Entered into a clinical trial collaboration with Bristol-Myers Squibb. The collaboration includes the supply of Opdivo for the Phase 1 dual combination arm of COM701 and Opdivo and a framework for expansion to additional combination studies, such as PVRIG and TIGIT blockers. In addition, Bristol-Myers Squibb made a $12 million equity investment in Compugen.
·
First patient dosed in the Phase 1 study for COM701.
·
First patient dosed in the Phase 1 study for BAY 1905254 which triggered a milestone payment of $7.8 million from Bayer.

Financial Results
Revenues for the third quarter of 2018 were $7.8 million, compared with $0 in the comparable period of 2017. The revenues for the quarter reflect the milestone achieved from Bayer AG in connection with the dosing of the first patient in the Phase 1 study of BAY 1905254.

R&D expenses for the third quarter ended September 30, 2018, were $7.8 million, compared with $7.6 million for the comparable period in 2017. R&D expenses continue to reflect pre-clinical expenses associated with COM902 in preparation of the IND application filing anticipated in 2019 and clinical expenses associated with the COM701 Phase 1 trial which was initiated in September 2018.

Net loss for the third quarter of 2018 was $3.1 million, or $0.05 per diluted share, compared with a net loss of $9.9 million, or $0.19 per diluted share, in the comparable period of 2017.

As of September 30, 2018, cash, cash related accounts, short-term and long-term bank deposits totaled $34.9 million, compared with $30.4 million at December 31, 2017. The quarter-end cash balance does not include the $12 million equity investment by Bristol-Myers Squibb or the $7.8 million for the milestone from Bayer AG. The Company has no debt.

Conference Call and Webcast Information
Compugen will hold a conference call to discuss its third quarter 2018 results today, November 7, 2018, at 8:30 a.m. ET. To access the live conference call by telephone, please dial 1-888-407-2553 from the U.S., or +972-3-918-0644 internationally. The conference call will also be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website www.cgen.com.

On November 7, 2018 Protalix BioTherapeutics, Inc. (NYSE American:PLX, TASE:PLX), a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx, reported its financial results for the three months and nine months ended September 30, 2018, and provided a corporate update (Press release, Protalix, NOV 7, 2018, View Source [SID1234531160]).

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"In the third quarter we achieved two important milestone events for pegunigalsidase alfa, or PRX-102, our differentiated enzyme replacement therapy in development for the treatment of Fabry disease. First, we expanded our partnership with Chiesi Farmaceutici S.p.A. to include exclusive rights to commercialize and develop PRX-102 in the United States, which significantly strengthened our financial position. Second, we reported positive preliminary results from our BRIDGE study on key kidney function," commented Moshe Manor, Protalix’s President and Chief Executive Officer. "Based on the promising preliminary BRIDGE study results, and taking into account the newly issued guidance from the U.S. Food and Drug Administration (FDA), we plan to engage with the FDA during the first half of 2019 to discuss the most optimal regulatory path forward for PRX-102. While we continue to enroll patients in all of our currently ongoing Fabry disease studies, we believe that with over 110 Fabry patients enrolled across the studies included in our PRX-102 clinical program to date, we have a sufficient number of patients for expedited review, including filing an application for accelerated approval," continued Mr. Manor.

2018 Third Quarter Highlights

·Presented preliminary positive data from the BRIDGE study showing Improvement in kidney function in patients switched from agalsidase alfa (Replagal) to pegunigalsidase alfa and further showing the reversal of a deterioration trend in kidney function to an improvement trend when switched.

·Expanded partnership with Chiesi Farmaceutici S.p.A., or Chiesi, to include U.S. rights for the development and commercialization of PRX-102. Terms of the agreement included an up-front payment of $25 million, up to $20 million in development costs and tiered royalties ranging from 15-40% of net sales.

·Expanded our Board of Directors with the addition of Mr. David Granot as an independent director.

·Continued exploring the potential for partnership opportunities mainly for OPRX-106, and for PRX-110. In parallel, the Company is exploring the option of conducting a controlled phase IIb study of OPRX-106 for the treatment of ulcerative colitis in order to maximize the value of this asset in a manner that will best serve the stockholders’ interest.

Financial Results for the Nine Months ended September 30, 2018

·The Company reported a net loss of $36.2 million, or $0.25 per share, basic and diluted for the nine-month period ended September 30, 2018 compared to a net loss of $32.1 million, or $0.25 per share, basic and diluted for the same period of 2017 excluding remeasurement of a derivative.

The Company recorded total revenues of $7.2 million for the nine-month period ended September 30, 2018, compared to $16.8 million for the same period of 2017. The decrease resulted primarily from decreased shipments of alfataliglicerase to Brazil despite the increase in the number of patients treated with alfataliglicerase, and decreased sales of drug substance to Pfizer.

The $25.0 million in proceeds received from Chiesi during the three-month period ended September 30, 2018 as an upfront payment were not recorded as revenues, and were deferred according to the revenue recognition rules of U.S. generally accepted accounting principles. Such proceeds should be recorded upon the commencement of commercial manufacturing. The same accounting treatment was applied to the $25.0 million upfront payment received by the Company in the fourth quarter of 2017, and the $11.8 million of research and development reimbursement payments the Company has received from Chiesi to date.

·Research and development expenses were $23.8 million for the nine-month period ended September 30, 2018, compared to $19.8 million for the same period of 2017.

Selling, general and administrative expenses were $7.3 million for the nine-month period ended September 30, 2018 compared to $8.2 million for the same period of 2017.

As of September 30, 2018, the Company had $41.9 million of cash and cash equivalents. With the expected decrease in cash consumption resulting primarily from the Company’s U.S. license transaction with Chiesi, the Company expects the cash balance to fund the Company through significant regulatory achievements of PRX-102.

Conference Call and Webcast Information

The Company will host a conference call on Wednesday, November 7, 2018 at 8:30 am ET to review the clinical, corporate and financial highlights.

To participate in the conference call, please dial the following numbers prior to the start of the call: United States: +1-844-358-6760; International: +1-478-219-0004. Conference ID number 8567317.

The conference call will also be broadcast live and available for replay for two weeks on the Company’s website, www.protalix.com, in the Events Calendar of the Investors section. Please access the Company’s website at least 15 minutes ahead of the conference to register, download, and install any necessary audio software.

On November 7, 2018 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported financial results for the quarter ended September 30, 2018 (Press release, MacroGenics, NOV 7, 2018, View Source [SID1234531176]).

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"During the third quarter, MacroGenics made tremendous progress in advancing its portfolio of immuno-oncology product candidates towards multiple near-term data read-outs," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "Given the Company’s substantial pipeline progress over the past several months, we believe that the next twelve months are poised to be transformative for MacroGenics, during which we expect to continue to advance our core mission of developing breakthrough biologics that may become life-changing medicines for patients."

Key Pipeline Updates
Margetuximab. Recent highlights related to the Company’s Fc-optimized monoclonal antibody (mAb) that targets the human epidermal growth factor receptor 2, or HER2, include:
• Fully Enrolled Phase 3 Metastatic Breast Cancer Study. The Company has completed enrollment of 530 relapsed/refractory HER2-positive metastatic breast cancer patients in its pivotal SOPHIA study. MacroGenics anticipates disclosure of topline PFS data in the first quarter of 2019. In anticipation of a potential future product launch, MacroGenics is progressing its U.S. commercial planning and actively exploring ex-U.S. development and commercialization partnership opportunities.
• Phase 2 Gastric Cancer Study Demonstrated Antitumor Activity. At the 2018 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in October, MacroGenics presented updated interim clinical data from a Phase 2 study of margetuximab plus an anti-PD-1 agent in patients with HER2-positive gastroesophageal adenocarcinoma. This chemotherapy-free combination, designed to coordinately engage innate and adaptive immunity, demonstrated antitumor activity in patients with advanced gastric cancer. The Company recently completed enrollment of 25 additional gastric cancer patients and expects to present data from this ongoing portion of the study in the first quarter of 2019.

PD-1 Franchise. MacroGenics is advancing multiple PD-1-directed programs to provide further differentiation from existing PD-1-based treatment options and enable a broad set of combination opportunities across the Company’s portfolio. Recent program highlights include:

Exhibit 99.1
• MGA012 Achieves Development Milestones. This anti-PD-1 mAb, also known as INCMGA0012, was licensed to Incyte Corporation in 2017 under a global collaboration and license agreement. MacroGenics retains the rights to develop MGA012 in combination with its pipeline assets. MGA012 met certain clinical proof-of-concept criteria, triggering a total of $15 million in milestones from Incyte, $10 million of which has been recognized in the third quarter and $5 million of which is expected to be recognized in the fourth quarter. Incyte plans to present updated data from the cohort expansion portion of the Phase 1 study of MGA012 in a poster session at the upcoming Society for Immunotherapy for Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. Incyte has announced its intention to pursue monotherapy development of MGA012 in MSI-high endometrial cancer, Merkel cell carcinoma and anal cancer through registration-directed studies with initial data anticipated in 2020. In addition, across both Incyte and MacroGenics, multiple studies have been initiated which will feature various combination regimens with MGA012.
• MGD013 Dose Expansion Initiated. This first-in-class DART molecule provides co-blockade of two immune checkpoint molecules expressed on T cells, PD-1 and LAG-3, for the potential treatment of a range of solid tumors and hematological malignancies. MacroGenics recently established the dose and schedule for MGD013 administration and has initiated dose expansion in up to nine tumor types in a Phase 1 study.
• MGD019 IND Cleared. This DART molecule is designed to provide co-blockade of both PD-1 and CTLA-4, two immune checkpoint inhibitors, on T cells. MacroGenics’ Investigational New Drug (IND) application for MGD019 was cleared by the FDA and the Company is currently engaged in Phase 1 study startup.
B7-H3 Franchise. MacroGenics is developing a portfolio of therapeutics that target B7-H3, a member of the B7 family of molecules involved in immune regulation. The Company is advancing multiple programs that target B7-H3 through complementary mechanisms of action that take advantage of this antigen’s broad expression across multiple solid tumor types. Recent program highlights include:
• Enoblituzumab Oral Presentation at SITC (Free SITC Whitepaper): Clinical data from MacroGenics’ study of this Fc-optimized mAb that targets B7-H3 combined with an anti-PD-1 mAb was selected for oral presentation at the upcoming SITC (Free SITC Whitepaper) Annual Meeting. Like the combination of margetuximab and anti-PD-1, enoblituzumab and anti-PD-1 is designed to leverage Fc-optimization and checkpoint blockade to coordinately engage innate and adaptive immunity, the two major components of the immune response. As an update of the recently released abstract, the combination of enoblituzumab and anti-PD-1 demonstrated antitumor activity in checkpoint inhibitor-naïve patients who had squamous cell carcinoma of the head and neck (SCCHN) and in checkpoint inhibitor-naïve patients with non-small cell lung cancer (NSCLC) with tumor PD-L1 expression of <1%. In these two cohorts, objective responses occurred in 6/18 (33%) response-evaluable SCCHN patients and in 5/14 (36%) response-evaluable NSCLC patients. Additional details will be provided at SITC (Free SITC Whitepaper).
• Orlotamab Studies Ongoing: This DART molecule targeting B7-H3 and CD3 is being evaluated in a Phase 1 monotherapy study in multiple tumor types. In addition, a combination study of orlotamab and MGA012 is ongoing.
• MGC018 Phase 1 Startup Initiated: MacroGenics’ IND submission for this anti-B7-H3 antibody-drug conjugate (ADC) was cleared by the FDA and the Company is initiating a Phase 1 study. This first-in-man study is designed to study MGC018 both as monotherapy and in combination with MGA012 in patients with solid tumors.
Flotetuzumab. Recent highlights of the Company’s bispecific, humanized DART molecule that recognizes both CD123 and CD3, include:
• Oral Presentations at ASH (Free ASH Whitepaper). MacroGenics plans to present both updated clinical data as well as gene signature data from its completed acute myeloid leukemia (AML) dose expansion cohort in two oral presentations at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting next month. The Company’s collaborator, Servier, has development and commercialization rights outside North America, Japan, Korea and India for flotetuzumab, also known as S80880.

Exhibit 99.1
• Combination Study with MGA012 Planned. MacroGenics has previously presented data supporting the rationale for using checkpoint blockade as an approach to potentially enhance the anti-leukemic activity of flotetuzumab and plans to commence a combination study with MGA012.

Third Quarter 2018 Financial Results
• Cash Position: Cash, cash equivalents and marketable securities as of September 30, 2018, were $260.1 million, compared to $305.1 million as of December 31, 2017.
• Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $20.8 million for the quarter ended September 30, 2018, compared to $1.7 million for the quarter ended September 30, 2017. This increase was primarily due to revenue recognized under the Incyte MGA012 collaboration. Revenue from collaborative agreements includes the recognition of deferred revenue from payments received in previous periods as well as payments received during the year.
• R&D Expenses: Research and development expenses were $46.2 million for the quarter ended September 30, 2018, compared to $41.0 million for the quarter ended September 30, 2017. This increase was primarily due to the initiation of combination studies of MGA012, continued enrollment in multiple ongoing studies, increased development/manufacturing costs related to MGA012, which were partially reimbursed by Incyte, and increased headcount to support expanded manufacturing and development activities.
• G&A Expenses: General and administrative expenses were $9.6 million for the quarter ended September 30, 2018, compared to $8.4 million for the quarter ended September 30, 2017. This increase was primarily due to increased patent-related expenses and consulting and other costs incurred related to the implementation of the Company’s new enterprise resource planning (ERP) system.
• Net Loss: Net loss was $34.0 million for the quarter ended September 30, 2018, compared to net loss of $47.0 million for the quarter ended September 30, 2017.
• Shares Outstanding: Shares outstanding as of September 30, 2018 were 42,248,075.

Conference Call Information

MacroGenics will host a conference call today at 4:30 pm (ET) to discuss financial results for the quarter ended September 30, 2018 and provide a corporate update. To participate in the conference call, please dial (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and provide the Conference ID: 6548008.

The recorded, listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company’s website at View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.

On November 6, 2018 CytomX Therapeutics, Inc. (Nasdaq: CTMX) a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, reported that clinical translational data from PROCLAIM-CX-072, an ongoing Phase 1/2 trial evaluating CX-072, a Probody therapeutic targeting PD-L1, will be presented as a poster and in a rapid fire oral presentation at the 33rd Annual Meeting of The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (Press release, CytomX Therapeutics, NOV 6, 2018, View Source [SID1234530788]). The conference will take place from November 7-11, 2018 in Washington, DC.

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Poster P87: Preliminary Evidence of Intratumoral Activation and Immunomodulatory Effect of CX-072, a Probody Therapeutic Antibody Prodrug Targeting PD-L1, in a Phase 1/2a Trial

Presenter: Luc Desnoyers, Ph.D., Senior Director of Translational Sciences, CytomX Therapeutics

Date/Time: November 9, 2018; 8:00 – 9:00 a.m. /12:45 – 2:45 p.m. /6:30 – 8:00 p.m. EST

Location: Poster Hall E, Walter E. Washington Convention Center

Preliminary Evidence of Intratumoral Activation and Immunomodulatory Effect of CX-072, a Probody Therapeutic Antibody Prodrug Targeting PD-L1, in a Phase 1/2a Trial

Presenter: Luc Desnoyers, Ph.D., Senior Director of Translational Sciences, CytomX Therapeutics

Session: Rapid Oral Abstracts

Date/ Time: November 10, 2018; 1:05 – 1:10 p.m. EST

Location: Poster Hall E, Walter E. Washington Convention Center
Analyst and Investor Event and Webcast

CytomX will host an Analyst and Investor event on Saturday, November 10, 2018 from 12:30 to 2:00 p.m. EST to review the SITC (Free SITC Whitepaper) clinical data presentation. Participants are invited to listen to a live audio webcast of the presentation at View Source or by dialing 1-877-809-6037 or 1-615-247-0221 and using code 4597498. The event will also be available for replay for 30 days on the company’s website, www.CytomX.com.

For analysts and investors interested in attending the event in person, please contact [email protected] as space is limited.