On September 26, 2019 Precision Optics Corporation, Inc. (OTCQB: PEYE), a leading designer and manufacturer of advanced optical instruments for the medical and defense industries, reported operating results on an unaudited basis for its fourth quarter and fiscal year ended June 30, 2019 (Press release, Precision Optics, SEP 26, 2019, View Source [SID1234539831]).

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Fourth quarter fiscal 2019 highlights:

Revenue for the quarter (ended June 30, 2019) was $2.4 million compared to $1.5 million in the same quarter of the previous fiscal year, an increase of 63% driven primarily by an increase in production revenue for medical devices that incorporate the Company’s Microprecision technology, as well as one month of contribution from Ross Optical.
Ross Optical contributed $656,000 to Precision Optics’ revenue during the month of June 2019.
Production revenue was $912,000 in the quarter, an increase of 18% compared to $770,000 in the same quarter of the previous fiscal year.
Gross margins of 36% in the quarter continued to improve sequentially for the second consecutive quarter.
Net loss of $109,000 during the quarter included $128,000 of business acquisition expenses and $117,000 of stock-based compensation.
Fiscal year 2019 highlights:

Revenue for the fiscal year (ended June 30, 2019) was $6.8 million compared to $4.0 million in the previous fiscal year, an increase of 69%.
Production revenue during the fiscal year increased 140% to $3.7 million compared to $1.5 million in the previous fiscal year.
Excluding the one-month contribution from Ross Optical, the fiscal year revenue was $6.1 million, an increase of 52% compared to the previous fiscal year.
Pro forma (assuming a full year of Ross Optical) financial highlight:

For the 12 months of fiscal year 2019 (ended June 30, 2019), pro forma financial results show a combined organization (Precision Optics and Ross Optical) with $10.5 million in sales and gross margin of approximately 36%.
Precision Optics’ CEO, Joseph Forkey, commented, "Our financial results from the fourth quarter and from fiscal year 2019 overall, continue to demonstrate the success of our business model. By utilizing our proprietary optical technology to develop and manufacture state-of-the art custom medical imaging products, we enable the world’s leading medical device companies to bring next generation, minimally invasive devices and 3D surgical robotic systems to market. The transition of a number of these Precision Optics enabled projects to commercialization by our customers drove a 140% increase in production revenues during fiscal 2019. Based on order visibility on currently commercialized products, as well as expected near-term commercialization of products currently in our pipeline, we believe fiscal 2020 should be another strong year for Precision Optics."

Dr. Forkey continued, "Fiscal 2019 was a milestone year for us also because of the acquisition of Ross Optical Industries. We completed this acquisition – the first ever for Precision Optics – on July 1st. One of the benefits of the acquisition is that it expands our readily accessible customer base, particularly in the defense industry, where we believe there are opportunities for use of our Microprecision micro optics and imaging systems. The acquisition also extends our product offering to include a wider range of lens and optical system sizes, drives economies of scale within our organization, and allows the combined company to leverage our technical proficiency in offering end-to-end solutions to the expansive Ross Optical customer base. We look forward to the many opportunities we believe are available to drive further growth and efficiencies in 2020 and beyond."

The following table summarizes the fourth quarter (unaudited) and year results for the periods ended June 30, 2019 and 2018:

Conference Call Details
The Company has scheduled a conference call to discuss the fiscal year end and fourth quarter 2019 financial results for Thursday, September 26, 2019 at 5:00 p.m. EDT.

Call-in Information: Interested parties can access the conference call by dialing (877) 317-6789 or (412) 317-6789.

Live Webcast Information: Interested parties can access the conference call via a live Internet webcast, which is available at View Source

Replay: A teleconference replay of the call will be available until October 3, 2019 at (877) 344-7529 or (412) 317-0088, confirmation #10135010. A webcast replay will be available at View Source

On September 26, 2019 Samsung Bioepis Co., Ltd. reported results from the Phase 3 study evaluating the efficacy and safety of SB8, a bevacizumab biosimilar candidate, compared to reference bevacizumab in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC) (Press release, Samsung Bioepis, SEP 26, 2019, View Source [SID1234539830]).ii The study results will be presented for the first time today at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Congress in Barcelona, Spain.

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"Data from this study showed that there were no clinically meaningful differences between SB8 and reference bevacizumab in terms of efficacy, safety, pharmacokinetics and immunogenicity," said Chul Kim, Senior Vice President and Head of Clinical Sciences Division, Samsung Bioepis. "We are committed to increasing access to high-quality, life-changing oncology medicines through the development of biosimilars to address some of oncology’s most pressing challenges."

The primary endpoint of the study was the overall response rate (ORR) by 24 weeks; risk ratio was analyzed in the full analysis set (FAS) with pre-defined equivalence margin of 0.737 to 1.357 and the risk difference was analyzed in the per-protocol set (PPS) with pre-defined equivalence margin of ±12.5%. The ORR in FAS was 47.6% for SB8 and 42.8% for reference bevacizumab; the risk ratio was 1.11 (90% CI: 0.975, 1.269). The ORR in PPS was 50.1% for SB8 and 44.8% for reference bevacizumab; the risk difference was 5.3% (95% CI: −2.2%, 12.9%). The median progression-free survival (8.5 months vs 7.9 months) and overall survival (14.9 months vs. 15.8 months) were comparable between SB8 and reference bevacizumab. The overall incidence of treatment-emergent adverse events (92.1% vs 91.1%) and the incidence of overall anti-drug antibodies (16.1% vs 11.0%) were also comparable between SB8 and reference bevacizumab.

Marketing Authorization Application (MAA) for SB8 was accepted for review by the European Medicines Agency (EMA) in July 2019.

The results of the SB8 Phase 3 study will be presented as a poster during ESMO (Free ESMO Whitepaper) as follows: [1565P] 12:00-13:00, September 28, Hall 4. Samsung Bioepis will also host a satellite symposium, titled ‘Quality Assurance to Optimize HER2+ Breast Cancer Treatment’, which will discuss the importance of quality maintenance in oncology biologics. The symposium will take place between 13:00-14:30 on September 30, 2019 in Toledo Auditorium, Hall 5, Fira Gran Via, Barcelona. Topics include:

Building confidence in biosimilars
Acknowledging importance of biologics quality in clinical practice
Reassuring biosimilarity based on clinical evidence
Interactive discussion: perspective on biosimilars in oncology
SB8 Phase 3 Study

The SB8 Phase 3 study is a randomized, double-blind, multicenter study evaluating the efficacy, safety, pharmacokinetics (PK), and immunogenicity of SB8 compared to reference bevacizumab in combination with paclitaxel and carboplatin in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC). 763 patients were randomized (1:1) to receive SB8 or reference bevacizumab with paclitaxel and carboplatin Q3W followed by SB8 or reference bevacizumab maintenance therapy until disease progression, unacceptable toxicity, death, or 1 year from the randomization of the last patient. The primary endpoint is the overall response rate (ORR) which is defined as the proportion of patients whose best overall response by 24 weeks is either complete response or partial response. Secondary endpoints were progression free survival (PFS), overall survival (OS), duration of response (DOR), safety, PK, and immunogenicity.

On September 26, 2019 ITM Isotopen Technologien München AG (ITM), a biotechnology and radiopharmaceutical group of companies, reported the appointment of Mona M Wahba, MD, MSM to the position of Deputy Chief Medical Officer (Press release, ITM Isotopen Technologien Munchen, SEP 26, 2019, View Source [SID1234539829]). Dr Wahba joined ITM on September 15, 2019 and will primarily be responsible for the development and implementation of ITM’s clinical strategy and presence in the United States (US), where Dr Wahba will be based. In this capacity Dr Wahba will also oversee the clinical conduct of the COMPETE phase III clinical trial in North America. This pivotal study is central to ITM’s global strategy of providing cutting edge radiotheranostic care to patients with neuroendocrine tumors.

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Prior to joining ITM, Dr Wahba has held several senior executive positions with major pharmaceutical companies including Pfizer, Bristol-Myers Squibb, Novartis, and Bayer. With more than 20 years of experience in senior management roles in the industry, she has extensive knowledge in medical affairs, drug safety and clinical development. Dr Wahba was instrumental in leading US and global medical plans and launch readiness of Xofigo, a radiopharmaceutical drug designed to treat bone metastases in patients with castration-resistant prostate cancer (CRPC). At Ipsen Bioscience Dr Wahba served as Clinical Development Lead, advancing the vision and strategy for clinical development of radiotheranostics in various tumor types.

"We are delighted to welcome Mona at ITM. Given her extensive experience in the industry and her strong medical background in oncology, radiotheranostics and immunology, she will be a key member of the developing medical team and a key asset to our US presence," said Dr Philip E Harris, CMO of ITM. "She will provide important clinical and medical input to our developing pipeline and commercial operations particularly in the United States, where our Phase III clinical trial is in an accelerated phase of actively recruiting patients."

"I am excited to join ITM at this pivotal moment in the company’s history, in which many interesting projects are underway," commented Dr Mona M Wahba, newly appointed Deputy CMO of ITM. "I am looking forward to helping patients with new treatment options as appropriate, to growing the company’s US footprint and to furthering the success of our phase III clinical trial COMPETE, which is currently investigating our lead candidate Solucin for the treatment of gastroentero-pancreatic neuroendocrine tumors. Targeted Radionuclide Therapy is an extremely precise and promising field that has the potential to improve the lives of countless cancer patients worldwide. I am looking forward to participating in developing and executing ITM’s promising pipeline to address unmet medical needs."

On September 26, 2019 ZielBio, Inc., an early-stage biotechnology company that identifies novel high value disease targets and develops therapeutic interventions to improve patient outcomes, reported that it has closed a $25.1 million Series A financing round (Press release, ZielBio, SEP 26, 2019, View Source [SID1234539828]). The round is led by Morningside Venture Investments and Partners Innovation Fund (PIF). ZielBio’s lead candidate ZB131 is a proprietary humanized monoclonal antibody against cell surface plectin (CSP), a target that is highly expressed on the plasma membrane of multiple types of cancer cells, including ovarian, pancreatic, lung and colorectal. The funding will enable the company to conduct further research to prioritize potential cancer applications, validate additional targets and initiate a planned phase 1 clinical trial with ZB131. "We are excited to partner with Morningside and PIF whose resources and drug development experience will greatly accelerate ZB131 development," noted Kimberly Kelly, PhD, President and Chief Science Officer at ZielBio.

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"Since its first discovery by ZielBio founder Dr. Kimberly Kelly at Massachusetts General Hospital, we have been encouraged by the unique role that cell surface plectin plays in proliferation, migration and cell survival and its potential as a drug target for a range of difficult to treat cancers," said PIF Partner Meredith Fisher, PhD. "Extensive pre-clinical laboratory and animal research has demonstrated that ZB131 has a high affinity to bind to CSP, inducing growth arrest and necrosis of targeted tumor cells."

"Despite the incredible progress being made in immuno-oncology, current therapies have limits and there remains a profound need for new targets and options for many deadly cancers," said Jason Dinges, JD, PhD, Investment Advisor at Morningside Technology Advisory. "ZB131 has shown potentially superior immune activation to current checkpoint inhibitors and greater direct tumor cell killing than EGFR inhibitors."

In connection with the financing, Drs. Dinges and Fisher have joined Dr. Kelly on the ZielBio Board of Directors.

On September 26, 2019 Flatiron Health reported 13 abstracts accepted for presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2019, which will be held September 27 – October 1, 2019, in Barcelona, Spain (Press release, Flatiron Health, SEP 26, 2019, View Source [SID1234539827]). The research, spanning multiple tumor types and areas of study, utilized Flatiron’s high-quality, real-world oncology datasets. Collectively, these research presentations highlight the various applications of real-world evidence, enabling deep clinical insights to better understand the use of biomarkers, comparative effectiveness of therapies and outcomes in routine clinical care.

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Presentations include collaborator research by the U.S. Food & Drug Administration’s Oncology Center of Excellence, Huntsman Cancer Institute, Yale Cancer Center, Bayer, Bristol-Myers Squibb, Celgene, Merck, Pfizer, Roche/Genentech and Foundation Medicine.

The presentation schedule and links to abstracts can be found below.

Poster Discussion
Prevalence and prognostic effect of high tumor mutation burden (TMB-H) across multiple less common solid cancers using a real-world dataset
● First Author: Daniel Backenroth (Flatiron Health)
● Date/Time: September 29 — 08:45 – 09:45
● Presentation: #1877PD

Poster Sessions
Second-line (2L) real-world treatment (tx) patterns and outcomes in patients (pts) with advanced/metastatic non-small cell lung cancer (NSCLC) treated with first-line (1L) immuno-oncology (IO) monotherapy (mono tx)
● First Author: Denis Talbot (University of Oxford)
● Date/Time: September 28 — 12:00 – 13:00
● Presentation: #1497P

Real-world effectiveness of nivolumab monotherapy after prior systemic therapy in advanced non-small cell lung cancer (NSCLC) in the United States
● First Author: David D. Stenehjem (University of Minnesota)
● Date/Time: September 28 — 12:00 – 13:00
● Presentation: #1498P

Treatment patterns and outcomes for patients (pts) with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) in US clinical practice
● First Author: Matthew G. Krebs (The Christie NHS Foundation Trust)
● Date/Time: September 28 — 12:00 – 13:00
● Presentation: #1546P

Brain metastases, treatment patterns and outcomes in ROS1-positive NSCLC patients from US oncology community centers
● First Author: Matthew G. Krebs (The Christie NHS Foundation Trust)
● Date/Time: September 28 — 12:00 – 13:00
● Presentation: #1551P

Biomarker status as a mediator of age-related overall survival (OS) in advanced non-small cell lung cancer (aNSCLC)
● First Author: Aaron B. Cohen (Flatiron Health)
● Date/Time: September 28 — 12:00 – 13:00
● Presentation: #1558P

Comparison of real-world response rate (rwRR) to RECIST-based response rate in patients with advanced non-small cell lung cancer (aNSCLC)
● First Author: Xinran Ma (Flatiron Health)
● Date/Time: September 28 — 12:00 – 13:00
● Presentation: #1581P

Palbociclib plus an aromatase inhibitor as first-line therapy for metastatic breast cancer in US clinical practices: Real-world progression-free survival analysis
● First Author: Mylin Torres (Winship Cancer Institute, Emory University School of Medicine)
● Date/Time: September 28 — 12:00 – 13:00
● Presentation: #327P

Comparative effectiveness of palbociclib plus letrozole vs letrozole for metastatic breast cancer in US real-world clinical practices
● First Author: Rachel M. Layman (Pfizer)
● Date/Time: September 30 — 12:00 – 13:00
● Presentation: #329P

Use of trastuzumab emtansine (T-DM1; K) after pertuzumab + trastuzumab (PH) in patients with HER2-positive metastatic breast cancer (mBC): Challenges in assessing effectiveness of treatment sequencing in the real world (RW)
● First Author: Thibaut Sanglier (Roche)
● Date/Time: September 30 — 12:00 – 13:00
● Presentation: #356P

Co-occurrence of NTRK fusions with other genomic biomarkers in cancer patients
● First Author: Xiaolong Jiao (Bayer)
● Date/Time: September 30 — 12:00 – 13:00
● Presentation: #102P

Association of programmed cell death 1 (PD-1) inhibitor therapy with overall survival (OS) in stage IV melanoma treated with targeted therapies
● First Author: Aracelis Z. Torres (Flatiron Health)
● Date/Time: September 30 — 12:00 – 13:00
● Presentation: #1290P

Comparative-effectiveness of pembrolizumab vs nivolumab for patients with metastatic melanoma
● First Author: Justin Moser (Huntsman Cancer Institute)
● Date/Time: September 30 — 12:00 – 13:00
● Presentation: #1346P