On November 5, 2019 DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new cancer therapies, reported it will host a cocktail reception featuring a panel discussion of Delmar’s glioblastoma multiforme (GBM) trial status with highly recognized thought leaders in GBM during the 2019 Society for NeuroOncology Annual Meeting in Phoenix, Ariz (Press release, DelMar Pharmaceuticals, NOV 5, 2019, View Source [SID1234550319]).

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The event will be held on November 22, 2019 at 4:15-5:30 PM MT at the JW Marriott Desert Ridge, 5350 E. Marriott Drive in Phoenix Ariz. in the Grand Sonoran Room (H-I). Panel participants to include:

John de Groot, M.D., professor and chairman ad interim, Department of Neuro-Oncology at The University of Texas M.D. Anderson Cancer Center
David Reardon, M.D., clinical director of the Center for Neuro-Oncology at the Dana Farber Cancer Institute and professor of Medicine at Harvard Medical School
Timothy Cloughesy, M.D., professor of neurology at the David Geffen School of Medicine at the University of California, Los Angeles and member of the UCLA Brain Research Institute and Jonsson Comprehensive Cancer Center.
Nicholas Butowski, M.D., neuro-oncologist practicing at UCSF Medical Center in San Francisco, Calif. and director of translational research in neuro-oncology at the Brain Tumor Center
Zhong-ping Chen, M.D., founder chairman of the Department of Neurosurgery/Neuro-oncology at Sun Yat-sen University Cancer Center, China and lead investigator of the Company’s Phase 2 clinical trial of VAL-083 in first-line treatment of MGMT-unmethylated GBM
Naureen Quibria, Ph.D., Equity Research Associate, Maxim Group – Moderator
For information or to sign up to attend this event, please send an email request to [email protected].

A recording of the event’s proceedings will be available shortly following on the Company’s website, www.delmarpharma.com.

On November 5, 2019 Portola Pharmaceuticals, Inc. (Nasdaq: PTLA) reported financial results for the three months ended September 30, 2019, and provided a corporate update (Press release, Portola Pharmaceuticals, NOV 5, 2019, View Source [SID1234550335]).

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"We delivered another quarter of strong Andexxa revenue in the U.S. and expanded our growth potential with our first sales of Ondexxya in Europe. The use of Factor Xa inhibitors in both markets continues to grow, driving the underlying market opportunity for Andexxa/Ondexxya and long-term value of Portola," said Scott Garland, Portola’s president and chief executive officer. "Looking forward, we will continue to focus on exceptional launch execution, leveraging external support from health authorities and favorable society guidelines, and building the clinical evidence and awareness of Andexxa. In addition, we remain on track to initiate a registration trial for cerdulatinib in early 2020 and will present updated data at the ASH (Free ASH Whitepaper) meeting in December."
Product Sales:

Total global revenues for the third quarter of 2019 were $36.8 million compared with $14.2 million for the third quarter of 2018. This includes $35.7 million in net product revenues from sales of Andexxa/Ondexxya [coagulation factor Xa (recombinant), inactivated-zhzo], $17,000 in revenues from Bevyxxa (betrixaban) sales and $1.1 million in collaboration and license revenues.

Net loss attributable to Portola, according to generally accepted accounting principles in the U.S. (GAAP) was $49.6 million, or $0.68 net loss per share for the third quarter of 2019, compared with a net loss of $71.3 million, or $1.08 net loss per share, for the same period in 2018.
Operating Expenses:
For the third quarter of 2019, compared to the same period in 2018:

Research and development (R&D) expenses decreased by $14.6 million, or 36.3%, primarily due to the manufacturing costs for Andexxa Gen 2 being capitalized and no longer flowing through R&D.

Selling, general and administrative (SG&A) expenses increased by $13.3 million, or 34.2%, due to commercial costs to support the Andexxa launch including the expansion of the field sales teams and launch preparations in Europe.

Cost of Sales (COS) were $2.7 million for the third quarter of 2019, compared to $4.3 million for the same period in 2018. This decrease was primarily due to transition from our Gen 1 to our Gen 2 Andexxa product.

These amounts on a GAAP and non-GAAP basis are reflected in the table below. A table reflecting the reconciliation of GAAP to non-GAAP amounts is included at the end of this release.

Cash, Cash Equivalents and Investments:

Cash, cash equivalents and investments at September 30, 2019, totaled $476.8 million, compared with $317.0 million as of December 31, 2018. During the third quarter, the Company added net proceeds of $245 million in connection with the follow on offering of the Company’s common stock.
Recent Achievements and Events

Ondexxya launched with $2.7 million of European net sales in the third quarter of 2019.

Andexxa added to the Veteran’s Health Administration national formulary, making access to 170 VA hospitals across the U.S. possible.

Andexxa recommended as first line therapy by The American Academy of Family Physicians (AAFP).

Centers for Medicare and Medicaid Services (CMS) New Technology Add-on Payment (NTAP) reimbursement for Andexxa increased from 50% to 65% effective on October 1, 2019.

Presented sub-analysis of ANNEXA-4 study at the American College of Gastroenterology annual meeting, highlighting the efficacy and safety of Andexxa in Factor Xa patients with acute gastrointestinal bleeding, which demonstrated excellent or good hemostasis achieved in 82% of evaluable patients.

Presented in vitro data at International Society of Thrombosis and Hemostasis annual meeting, demonstrating that four-factor prothrombin complex concentrate (4F-PCC) does not appear to have an effect on the inhibition of thrombin generation by apixaban or rivaroxaban unless the Factor Xa inhibitor concentration was less than 75 ng/mL. In contrast, data from the same thrombin generation assay demonstrated that Andexxa fully corrected the inhibition of thrombin generation by apixaban and rivaroxaban across a broad range of inhibitor concentrations.

Net proceeds of $245 million raised in a public offering of the Company’s common stock.
Planned Upcoming Milestones

Continue launch of Ondexxya in a select group of high-potential European countries with significant usage of Factor Xa inhibitors and supportive access and reimbursement.

Plan to initiate an urgent surgery study for Andexxa by year end or in early 2020.

Plan to launch a cerdulatinib registration study in peripheral T-cell lymphoma (PTCL) in early 2020.

Multiple abstracts related to Andexxa and cerdulatinib accepted for presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December.
Analyst and Investor Meeting
Portola will host an analyst and investor meeting focused on Andexxa on Thursday, November 14, 2019, from 8:00 to 10:30 a.m. ET in New York. Seating is limited to those who RSVP. Please contact [email protected] for an invitation. The event will also be webcast live and can be accessed live on the Investor Relations section of the Company’s website at View Source It will be archived for one year following the date of the event.

Conference Call Details
Portola will host a conference call today, Tuesday, November 5, 2019, at 4:30 p.m. ET, during which time management will discuss the third quarter 2019 financial results, updates on the U.S. and European launch of Andexxa/Ondexxya, and its operations. The live call can be accessed by phone by calling (844) 452-6828 from the United States and Canada or 1 (765) 507-2588 internationally and using the passcode 2980632. The webcast can be accessed live on the Investor Relations section of the Company’s website at View Source It will be archived for 30 days following the call.
Use of Non-GAAP Financial Measures
This press release and the reconciliation table included herein include non-GAAP R&D expenses. The Company believes the presentation of non-GAAP financial measures provides useful information to management and investors regarding the Company’s financial condition and results of operations. When viewed in conjunction with GAAP financial measures, investors are provided with a more meaningful understanding of the Company’s ongoing operating performance and are better able to compare the Company’s performance between periods. In addition, these non-GAAP financial measures are among those that the Company uses as a basis for evaluating performance, allocating resources and planning and forecasting future periods. Non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP financial measures. A reconciliation of GAAP to non-GAAP financial measures is provided in the accompanying table entitled "Reconciliation of GAAP to Non-GAAP Financial Informati

On November 5, 2019 Reata Pharmaceuticals, Inc. (Nasdaq: RETA), a clinical-stage biopharmaceutical company, reported that it will report financial results and provide an update on recent progress on its development programs on November 12, 2019, before the market opens (Press release, Reata Pharmaceuticals, NOV 5, 2019, View Source [SID1234550351]).

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Reata’s management with host a conference call at at 8:00 a.m. ET. The conference call will be accessible by dialing (844) 348-3946 (toll-free domestic) or (213) 358-0892 (international) using the access code: 4159656. The webcast link is View Source

Third quarter financial results to be discussed during the call will be included in an earnings press release that will be available on the company’s website shortly before the call at View Source and will be available for 12 months after the call. The audio recording and webcast will be accessible for at least 90 days after the event at View Source.

On November 5, 2019 OncoNano Medicine, Inc., a biotechnology company developing ultra pH-sensitive micelles for the detection, staging and treatment of cancer, reported two poster presentations – including a late-breaking abstract – for the Society for the Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting to be held in National Harbor, Maryland, November 6-10 (Press release, OncoNano Medicine, NOV 5, 2019, View Source [SID1234550367]). OncoNano’s core technology is a library of tunable, ultra pH-sensitive micelles that exist intact under baseline physiological pH conditions but dissociate to release their payload under different, predesignated pH levels.

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"We are very pleased to share data for two of our lead products at the SITC (Free SITC Whitepaper) Annual Meeting this year," commented Ravi Srinivasan, CEO of OncoNano Medicine. "Our proprietary micelle technology is designed to enable us to deliver high-value and challenging payloads to target tissues with high specificity in ways that have not been possible before."

The first poster, which is a late-breaking abstract, will feature ONM-500 [Mi-Vax] – an injectable micelle composed of STING (Stimulator of Interferon Genes)-activating polymers and packaged with a human papilloma virus tumor specific antigen. These micelles are subcutaneously injected where they accumulate in the lymph nodes and are endocytosed by dendritic cells. The lower pH of intracellular endosomes causes micelle dissociation, releasing both the antigen and STING-activating polymer to coordinate a targeted attack on cancer cells. OncoNano was awarded a grant from the Cancer Prevention and Research Institute of Texas (CPRIT) to continue the advancement of ONM-500 through pre-clinical and clinical development.

The second poster features ONM-400 [ON-BOARD], OncoNano’s injectable pH-sensitive therapeutic delivery platform that exploits a universal feature of cancer, the relatively acidic tumor microenvironment. ONM-400 can be loaded or conjugated with a variety of cancer therapeutics including cytokines, small molecules and engineered antibody fragments to focus therapeutic delivery specifically at the site of the tumor, minimizing off-target delivery to potentially improve the efficacy and safety profile. OncoNano plans to continue advancing the ONM-400 program through preclinical development and toward the clinical stage where there is substantial unmet need for more effective strategies to target cancer.

Late-breaking Poster Presentation
Abstract title: ONM-500 – A Novel STING-Activating Therapeutic Nanovaccine Platform for Cancer Immunotherapy
Presenting Author: Jason B. Miller, Ph.D., OncoNano Medicine, Inc.
Poster Number: P857
Date: November 8, 2019, 12:30-2:00 PM and 6:30-8:00 PM

Poster Presentation
Abstract title: Delivery of Interleukin-2 to the Acidic Tumor Microenvironment by Ultra-pH Sensitive Nanoparticles for Immunotherapy
Presenting Author: Xinliang Ding, Ph.D., OncoNano Medicine, Inc.
Poster Number: P617
Date: November 8, 2019, 12:30-2:00 PM and 6:30-8:00 PM

On November 5, 2019 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported preliminary results from its ongoing Phase 1 dose escalation study of COM701, a first-in-class anti-PVRIG antibody, in patients with advanced solid tumors (Press release, Compugen, NOV 5, 2019, View Source [SID1234550384]). COM701 was well-tolerated with no dose-limiting toxicities observed. Furthermore, COM701 demonstrated initial signals of anti-tumor activity in the heavily pretreated patient population enrolled on the study. The clinical data will be presented in a poster titled "Phase 1 Study of the Safety, Tolerability and Preliminary Anti-Tumor Activity of COM701 Monotherapy in Patients with Advanced Solid Tumors" at the 34th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2019) on Friday, November 8, 2019.

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"We are encouraged by the emerging safety profile and initial signals of anti-tumor activity of COM701. While the primary objective of this portion of the trial was to test the safety and tolerability of COM701, we were excited to observe early signals of anti-tumor activity in the all-comer, extensively pretreated patient population enrolled, including patients with microsatellite stable colorectal cancer (MSS-CRC), which we may choose to further evaluate in future studies," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "We believe COM701 has the potential to broaden the checkpoint inhibitor landscape with a biology driven prioritization rationale that addresses indications most relevant to the PVRIG pathway. We look forward to initiating our biomarker driven COM701 monotherapy expansion cohorts in these four prioritized indications – ovarian, endometrial, breast and lung cancers."

Ecaterina Ileana Dumbrava, M.D., Assistant Professor, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center and presenting author, said "Expanding the reach of cancer immunotherapy drugs to broader patient populations is an urgent need given the number of patients with advanced cancer who are non-responsive or refractory to currently available therapies. The initial signals of anti-tumor activity of COM701 are encouraging, particularly given the heavily pretreated all-comer patient population, with the majority of patients refractory to previous therapy. We observed a trend in dose-response relationship in this hard-to-treat patient population and furthermore, encouraging signals of anti-tumor activity in five out of six treated patients with MSS colorectal, a challenging indication, typically not responsive to current immune checkpoint blockers."

The reported data are from the monotherapy arm of the ongoing, Phase 1, open-label, dose escalation study and include the first seven (7) cohorts (n=13) at dose levels of 0.01, 0.03, 0.1, 0.3, 1, 3, and 10 mg/kg IV every three (3) weeks.

Key findings presented at the poster in SITC (Free SITC Whitepaper) include data updated as of October 15, 2019:

COM701 was well-tolerated through 10 mg/kg with no dose-limiting toxicities observed.
The best timepoint response of stable disease (SD)/disease control rate reported in 9 of 13 patients (69%) with a median of seven prior anticancer therapies (range of 2-15).
All the patients with CRC (N=6) had microsatellite stable status, and 5 of 6 patients (83%) had best timepoint response of stable disease.
Pharmacokinetic profile supports IV Q3 weekly dosing.
Peripheral PVRIG receptor occupancy greater than or equal to 90% was demonstrated at COM701 ≥1 mg/kg.
There are two patients remaining on study treatment with COM701 monotherapy.
Enrollment to COM701 monotherapy dose at 20 mg/kg Q4 weekly is on-going.

The poster will be available on Compugen’s website following the poster presentation.

About the COM701 Phase 1 Study

The Phase 1 open-label clinical trial of COM701 (anti-PVRIG antibody) is designed to assess the safety and tolerability of administering escalating doses of COM701 monotherapy as well as of combination administration with Bristol-Myers Squibb’s Opdivo (nivolumab) in patients with advanced solid tumors. Additionally, secondary endpoints include preliminary anti-tumor activity, pharmacokinetics and pharmacodynamics of COM701 monotherapy as well as COM701 in combination with Opdivo in patients with selected tumor types, including non-small cell lung cancer, ovarian cancer, breast cancer and endometrial cancer. The Phase 1 study, which is expected to enroll approximately 140 patients, is currently recruiting in the United States. Additional information is available at www.clinicaltrials.gov (NTC03667716).