On October 22, 2019 TLC (Nasdaq: TLC, TWO: 4152), a clinical-stage specialty pharmaceutical company developing novel nanomedicines to target areas of unmet medical need in pain management, ophthalmology and oncology, reported financial results for the third quarter ended September 30, 2019, and provided a business update (Press release, Taiwan Liposome Company, OCT 22, 2019, View Source [SID1234542414]).

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!

"The third quarter of 2019 showed continued significant progress for TLC, as we kicked off the Phase III clinical trial of TLC599 for osteoarthritis knee pain," said George Yeh, President of TLC. "We are hopeful that results from this pivotal trial will support a New Drug Application (NDA) submission for TLC599 with the US Food and Drug Administration (FDA). We also continue to advance our broad pipeline, with last patient enrollment of the Phase II clinical trial of TLC590 for the treatment of postsurgical pain expected in the first half of 2020. In addition, the timely addition of Dr. Vincent Chang to our team as Vice President of Manufacturing and Development reflects our investment towards ensuring that we have the best quality supply for our clinical trials and are well-positioned to move forward for potential commercial launches."

Clinical Pipeline Update and Upcoming Milestones

Initiation of Phase III pivotal clinical trial of TLC599 osteoarthritis knee. The multi-center, randomized, double-blind, placebo- and active comparator-controlled study, "EXCELLENCE", will treat about 500 patients at 40-50 sites in the United States and Australia to evaluate the safety and efficacy of single and repeated doses of TLC599 for up to 52 weeks.

Potential cartilage-protecting effects of TLC599 will be presented in a poster at 2019 ACR/ARP Annual Meeting in Atlanta, GA, on November 12, 2019. Magnetic resonance imaging (MRI) evaluation suggests slowing of cartilage damage and potential chondroprotection in osteoarthritis of the knee.

E-poster presentation at ANESTHESIOLOGY 2019 showed TLC590 for the management of postsurgical pain to yield more immediate and longer lasting pain relief than ropivacaine in hernia repair surgery. A publication in the International Journal of Nanomedicine details the ten-fold half-life of TLC590 and its prolonged analgesic effect compared to ropivacaine in preclinical studies. A Phase II, randomized, double-blind, comparator- and placebo-controlled clinical trial to evaluate the safety, pharmacokinetics and efficacy of TLC590 following bunionectomy is ongoing; enrollment of the last patient is expected to take place in the first half of 2020.

Poster presentation at ESMO (Free ESMO Whitepaper) 2019 demonstrated the potential of TLC178 (liposomal vinorelbine) to treat sarcomas with decreased dosing frequency and reduced toxicity. In preclinical studies, TLC178 exhibited more anti-tumor activity than a) doxorubicin in the soft tissue sarcoma model and b) both non-liposomal vinorelbine (VNB) and VNB + cyclophosphamide in the rhabdomyosarcoma model, and showed an improved pharmacokinetic profile and five-fold accumulation at the tumor site compared to VNB. An ongoing Phase I/II dose escalation clinical trial in adults has recruited 33 patients thus far.　
Corporate Highlights

Appointment of new Vice President of Manufacturing Development. Vincent Chang, PhD, has a deep experience in process development, project management and quality assurance attained from over 35 years at Abbott, Roche, GlaxoSmithKline and Bayer. Dr. Chang will guide the Company in affairs related to the chemistry, manufacturing and controls of its product candidates.

Provided updates at Baird Global Healthcare Conference and Janney Healthcare Conference; discussed TLC’s pain programs at BTIG Pain Management Forumamong a panel of experts and key opinion leaders as to the potential benefits of TLC599 and TLC590 as non-opioid treatments for pain.

Expanded global intellectual property protection to 140 patents, with 63 patents granted and 77 applications worldwide as of September 30, 2019.
Third Quarter 2019 Financial Results

Operating revenue for the third quarter of fiscal 2019 was NT$18.8 million (US$0.6 million), a 23.3% increase compared to NT$15.3 million (US$0.5 million) in the third quarter of fiscal 2018. Operating expenses for the third quarter of fiscal 2019 was NT$198.1 million (US$6.4 million), a 9.5% decrease compared to NT$218.9 million (US$7.2 million) in the third quarter of fiscal 2018. Net loss for the third quarter of fiscal 2019 was NT$178.4 million (US$5.7 million), compared to a loss of NT$196.0 million (US$6.4 million) in the third quarter of 2018, or a net loss of NT$2.80(US$0.09) per share for the third quarter of fiscal 2019, compared to a net loss of NT$3.52(US$0.12) per share for the third quarter of fiscal 2018.

The Company’s cash and cash equivalents and time deposits with maturity over three months (which are classified as "current financial assets at amortized cost" in the Company’s consolidated financial statements) were NT$1,007.5 million (US$32.5 million) as of September 30, 2019, compared to NT$1,114.6 million (US$36.4 million) as of December 31, 2018.

On October 22, 2019 Veracyte, Inc. (Nasdaq: VCYT) reported financial results and business progress for the third quarter ended September 30, 2019. For the third quarter of 2019, revenue was $31.0 million, an increase of 32% over the third quarter of 2018 (Press release, Veracyte, OCT 22, 2019, View Source [SID1234542412]). Net cash used in operating activities in the third quarter of 2019 was $1.6 million, an improvement of 13% compared with the third quarter of 2018.

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!

"We had a solid third quarter in which we continued to drive volume and revenue growth across our products and grew biopharmaceutical services revenue through key milestone achievements," said Bonnie H. Anderson, chairman and chief executive officer of Veracyte. "We are particularly excited by the new, preliminary data for our noninvasive nasal swab test for early lung cancer detection, which we believe has significant potential to improve care among the millions of patients with suspicious lung nodules detected each year. Importantly, as we grow our business and advance our pipeline, we remain on track to achieve our goal of reaching cashflow breakeven status before the end of the year."

Third Quarter 2019 Financial Results

For the third quarter of 2019 as compared with the third quarter of 2018:

Revenue was $31.0 million, an increase of 32%; excluding $4.3 million of biopharmaceutical services revenue, revenue was $26.7 million, an increase of 15%.
Gross Margin was 71%, an increase of six percentage points; excluding biopharmaceutical services revenue, gross margin was 66%, an increase of two percentage points.
Operating Expenses, Excluding Cost of Revenue were $23.6 million, an increase of 21%.
Net Loss was $0.7 million, an improvement of 84%.
Net Loss Per Share was $0.02, an improvement of 83%.
Net Cash Used in Operating Activities was $1.6 million, an improvement of 13%.
Cash and Cash Equivalents were $195.7 million at September 30, 2019.
For the nine-month period ended September 30, 2019, as compared with the prior year period of 2018:

Revenue was $90.6 million, an increase of 37%; excluding $11.8 million of biopharmaceutical services revenue, revenue was $78.8 million, an increase of 20%.
Gross Margin was 71%, an increase of eight percentage points; excluding biopharmaceutical services revenue, gross margin was 66%, an increase of three percentage points.
Operating Expenses, Excluding Cost of Revenue were $71.2 million, an increase of 17%.
Net Loss was $5.1 million, an improvement of 74%.
Net Loss Per Share was $0.11, an improvement of 80%.
Net Cash Used in Operating Activities was $5.0 million, an improvement of 59%.
Third Quarter 2019 and Recent Business Highlights

Commercial Growth and Reimbursement Expansion:

Grew total genomic test volume in the third quarter of 2019 to 9,941, an increase of 24% over the third quarter of 2018.
– Increased Percepta Genomic Sequencing Classifier (GSC) volume to 793 tests, an increase of 112% compared to the third quarter of 2018.

– Expanded Envisia Genomic Classifier volume to 223 tests, a Q3 2019 growth sequentially over Q2 2019 of 72%.

– Grew Afirma test volume to 8,925 tests, an increase of 17%, compared to the third quarter of last year.

Strengthened Library of Clinical Evidence:

Published a clinical and analytical validation paper in Frontiers in Endocrinology demonstrating the Afirma Xpression Atlas’s ability to help inform surgery and treatment decisions in patients with thyroid nodules deemed suspicious for cancer by the Afirma Genomic Sequencing Classifier. A separate paper published in Thyroid reinforced the test’s potential value in clinical practice.
Five studies are being presented at the annual meeting of the American College of Chest Physicians (CHEST 2019), including:
– Three abstracts showing that the Envisia classifier enhances physicians’ ability to confidently distinguish idiopathic pulmonary fibrosis from other interstitial lung diseases when used with high-resolution CT imaging.

– Two abstracts demonstrating the clinical validity and utility, respectively, of the Percepta classifier in lung cancer diagnosis when bronchoscopy findings are inconclusive.

Advanced Pipeline:

Presented data at CHEST 2019 demonstrating the ability of the company’s preliminary nasal swab test to enable early lung cancer detection and diagnosis. The findings show that the test can accurately classify lung cancer risk in patients with lung nodules so that they may be directed to prompt diagnosis and treatment or may be monitored noninvasively.
Updated 2019 Financial Outlook

Veracyte is re-affirming its 2019 annual revenue guidance of $119 million to $122 million and net cash used in operating activities of $2 million to $4 million.

Conference Call and Webcast Details

Veracyte will host a conference call and webcast to discuss its financial results and provide a general business update at 5:00 p.m. Eastern time today.

The conference call will be webcast live from the company’s website and will be available via the following link: View Source webcast should be accessed 10 minutes prior to the conference call start time.

A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at View Source

The conference call can be accessed as follows:

U.S./Canada participant dial-in number (toll-free):

(855) 541-0980

International participant dial-in number:

(970) 315-0440

Conference I.D.:

8767084

On October 22, 2019 Trillium Therapeutics Inc. (Trillium, ‘the company") (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported corporate restructuring to extend the company’s cash runway and to focus on critical value-creating activities (Press release, Trillium Therapeutics, OCT 22, 2019, View Source [SID1234542411]). The company also provided an update on its clinical development and research programs.

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!

"Since assuming the CEO role a month ago, my immediate focus has been on conducting an in-depth review of our strategic priorities and ongoing programs, as well as our available resources", said Jan Skvarka, President and Chief Executive Officer of the company. "Building on our strong scientific foundation, the goal of this restructuring is to create a leaner, more clinical development-centric organization and extend our cash runway. The near-term focus will be on the clinical development of intravenously administered TTI-621, our anti-CD47 product candidate that has shown promising preliminary evidence of activity in a number of hematologic malignancies. Unfortunately the restructuring will impact many highly talented and dedicated employees. Trillium would not exist without their contributions, for which we will always be deeply grateful."

Corporate Restructuring

Under the restructuring program, staff will be reduced by 40%, from 43 to 26 active employees, with immediate effect. The company will discontinue its discovery research activities to focus on clinical development and seek a partner for further development of its preclinical STING agonist program. Further cost savings will be achieved through operational efficiencies.

These savings are expected to reduce cash outlay from approximately CDN$10 million per quarter in the first half of 2019 to approximately CDN$4-7 million per quarter in 2020. The company currently expects to have cash and cash equivalents of approximately CDN$36 million at the end of the third quarter of 2019.

CD47 Program Update

The ongoing dose escalation trial of intravenously administered TTI-621 is on track and remains the key strategic priority going forward. The 0.7 mg/kg dose cohort in this study has been completed and no dose-limiting toxicities have been identified. Enrollment in the 1.0 mg/kg cohort is beginning. The goal of this trial is to identify a recommended phase 2 dose to enable additional studies in both cutaneous T-cell lymphoma (CTCL) and other hematologic malignancy indications with high unmet medical need.

In September, the company met with the U.S. Food and Drug Administration (FDA) which provided guidance on the intratumoral use of TTI-621 for the treatment of early-stage CTCL, including aspects of a potential registration study. The company is evaluating this guidance and considering options going forward, given current resource constraints. The ongoing phase 1b intratumoral trial, which provided the data set for the FDA interaction and informed the guidance, will now be closed.

On October 22, 2019 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, and PrECOG LLC, a leading cancer research network, reported their collaboration in which PrECOG will run the BRACELET-1 (PrE0113) study (Press release, Oncolytics Biotech, OCT 22, 2019, View Source [SID1234542410]). The principal investigator will be Kathy Miller, MD, Ballve-Lantero Professor of Oncology at Indiana University School of Medicine and Associate Director of Clinical Research at Indiana University Melvin and Bren Simon Cancer Center, and PrECOG member. The study will take place in 15 centers in the United States and will evaluate the ability of pelareorep to make tumors immunologically visible to checkpoint inhibitors.

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!

"We’re very excited to be working with PrECOG on the BRACELET-1 study focused on hormone receptor-positive metastatic breast cancer patients, our target patient population," said Rita Laeufle, Chief Medical Officer at Oncolytics Biotech. "Our goal in this study is to confirm our biomarker of T cell clonality in order to predictively and prognostically select patients for the phase three study, as well as to demonstrate that pelareorep sensitizes the tumor to immunotherapy and improves clinical outcomes. By creating an immunogenic tumor environment with pelareorep, we can potentially increase the efficacy of checkpoint blockade and treat more patients with this novel treatment combination. This important study, along with our ongoing AWARE-1 trial, will help determine the design of the phase three registrational program for pelareorep in metastatic breast cancer, which we expect may involve combination therapy with a checkpoint inhibitor."

"We in PrECOG are excited to be investigating this novel approach to breast cancer treatment, and to bring cutting edge options to our patients," said Peter O’ Dwyer, MD, Chief Executive Officer, PrECOG, and Co-Chair, ECOG-ACRIN Cancer Research Group. "Approaches to increase the activity of these immunologically active agents are a focus of our research and studies like this have the potential to be relevant to these mechanisms across many tumor types."

PrECOG has multiple trials in the immuno-oncology space. "Immunotherapy remains in its infancy in the treatment of breast cancer. The potential for pelareorep to extend the benefits of immunotherapy to patients with hormone-sensitive disease could be a real advantage for patients," said Dr. Miller.

The BRACELET-1 (PrE0113) study seeks to replicate a previous trial that supported an advantage in overall survival through the use of pelareorep in patients with hormone receptor-positive (HR+) metastatic breast cancer. It is being designed as a phase 2, three-arm, 48-patient open-label study for second-line treatment in these patients. The first arm will be paclitaxel alone, the second arm will be paclitaxel plus pelareorep, and the third arm will be paclitaxel plus pelareorep, plus the PD-L1 checkpoint inhibitor, avelumab.

The design is expected to be finalized in the coming weeks with input from Oncolytics’ co-development partners Pfizer and Merck KGaA. It will then go to the FDA for review. The study is anticipated to begin enrollment in Q1 2020.

About Pelareorep
Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

About PrECOG
PrECOG, LLC is a cancer research group formed as a not-for-profit limited liability company in 2006 by the ECOG Research and Education Foundation, Inc. A central focus of PrECOG is to support the overall purpose of the ECOG-ACRIN Cancer Research Group. Its goal is to achieve research advances in all aspects of cancer care, reduce the burden of cancer, and improve the quality of life and survival in patients with cancer. PrECOG’s current portfolio includes exploratory phase 1 and 2 studies as well as phase 3 registration studies conducted in the US and the EU. For further information, please visit www.precogllc.org and www.ecog-acrin.org.

On October 22, 2019 Nurix Therapeutics, Inc., a company developing therapies that control disease-causing proteins, reported that it will present data on its wholly-owned, CBL-B small molecule drug development program at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting (SITC 2019) (Press release, Nurix Therapeutics, OCT 22, 2019, View Source [SID1234542409]). SITC (Free SITC Whitepaper) is being held on November 6-10, 2019 at the Gaylord National Hotel and Convention Center in National Harbor, Maryland.

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!

Presentation Details:
Title: Pharmacological evaluation of the ubiquitin ligase CBL-B as a small molecule, tumor immunotherapy target
Poster #: P669
Date: Friday, November 8, 2019
Time: 7:00 a.m. – 8:00 p.m. EST