On September 24, 2020 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, 2020 (Press release, Precision Optics, SEP 24, 2020, View Source [SID1234565617]).

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The Company previously announced preliminary fourth quarter and fiscal year 2020 revenue on August 13, 2020.

Fourth quarter fiscal 2020 highlights:

Revenue for the quarter ended June 30, 2020 was $2.24 million compared to $2.38 million in the same quarter of the previous fiscal year, a decrease of 6%. Revenue for the quarter was down year over year on an actual and pro forma basis due to impacts of the COVID-19 pandemic.
Gross margins for the quarter were 29% compared with 31% in the same quarter of the previous fiscal year. This decline in margin was primarily driven by lower revenue and impacts of COVID-19.
Operating expenses decreased more than $300,000 during the fourth quarter of fiscal 2020 compared to the third quarter of fiscal 2020.
Net loss of $323,085 during the quarter included $75,567 of stock-based compensation.
The Company’s cash balance at June 30, 2020 was $1.1 million reflecting the Company’s aggressive cash management initiatives, coupled with proceeds from an equity financing in April 2020 and receipt of funding under the PPP.
Fiscal year 2020 highlights:

Revenue for the fiscal year ended June 30, 2020 was $9.9 million compared to $6.8 million in the previous fiscal year, an increase of 46% driven primarily by Ross Optical operating as a division of Precision Optics for the entire year. Revenue for the year was down year over year on a pro forma basis due to impacts of the COVID-19 pandemic.
Gross margins for the fiscal year ended June 30, 2020 were 34% compared to 31% for the previous fiscal year.
Net loss of $1,426,150 during the fiscal year included $547,345 of stock-based compensation.
On April 14, 2020 the Company raised $250,000 from existing accredited investors with the sale of 200,000 shares at a purchase price of $1.25 per share. On May 7, 2020 the Company received an $809,000 loan from the Small Business Administration (SBA) Paycheck Protection Program.
Precision Optics’ CEO, Joseph Forkey, commented, "Our financial results for the fourth quarter and fiscal year were consistent with our preliminary results announced in mid-August, reflecting the positive contributions from our Ross Optical acquisition offset by impacts to certain aspects of our operations due to COVID-19. We believe the near-term disruptions that we experienced in the third and fourth quarters of fiscal 2020 due to COVID-19 have begun to subside with an expectation that we will see improvements in first quarter fiscal 2021 revenue and gross margins, as compared to the fourth quarter of fiscal 2020."

Dr. Forkey continued, "Our three recently commercialized production programs all continue at levels similar to recent months and we are advancing other programs in development toward production. There are also a number of new opportunities we are pursuing with combined significant revenue potential. One program including prototype deliveries for a new defense / aerospace customer is a great example of the successful integration of Ross Optical. There are clearly macro challenges in the economy but we believe continued execution in our core business plus investment in high opportunity products and markets will lead to strong growth in our business going forward."

The following table summarizes the fourth quarter and fiscal year (unaudited) results for the periods ended June 30, 2020 and 2019:

Conference Call Detailsp0o
The Company has scheduled a conference call to discuss the fourth quarter and fiscal year 2020 financial results for Thursday, September 24, 2020 at 5:00 p.m. EDT.

Call-in Information: Interested parties can access the conference call by dialing (844) 735-3662 or (412) 317-5705.

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 1, 2020 at (877) 344-7529 or (412) 317-0088 confirmation # 10147933. A webcast replay will be available at View Source

On September 24, 2020 XiangXue Life Sciences reported that it received US permission to start a Phase I trial of its high affinity specific T-cell receptor candidate, TCRT-ESO-A2 (Press release, Xiangxue Life Sciences, SEP 24, 2020, View Source [SID1234565602]). The molecule is China’s first TCR-T candidate to target solid tumors, aiming at tumors that are NY-ESO-1 positive in HLA-A*02:01 positive patients. XLifeSc is a subsidiary of Guangzhou XiangXue Pharma that focuses on TCR therapies for cancer. TCRT-ESO-A2 is being developed globally (ex-China) by Axis Therapeutics, a JV formed by XLifeSc and Athenex, a US-China biopharma.

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On September 24, 2020 KYAN Therapeutics, Inc. ("KYAN"), a frontier biotech company with a novel drug-dose combination optimizing platform, Optim.AI,reported that it has entered into an exclusive license agreement with Georgetown University for novel selective Class II HDAC inhibitors (Press release, KYAN Therapeutics, SEP 24, 2020, View Source [SID1234565597]). KYAN has already commenced preclinical development of the lead candidate, which has been designated as KYAN-001, with early positive results.

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In vitro and in vivo studies of KYAN-001 have shown high efficacy for Multiple Myeloma and Prostate Cancer. The low toxicity and metabolic stability of KYAN-001 indicates a better safety and tolerability profile than FDA approved pan-HDAC inhibitors which suffer from toxicity issues and side effects. KYAN-001 also uniquely inhibits HDAC4 nucleoshuttling to further drive its anti-cancer effects.

"We’re very excited to proceed with KYAN-001 because of its promising features and we are confident that we can identify optimal combination therapies across multiple cancer indications with Optim.AI," said Lisa Chow, COO and General Counsel of KYAN.

Masturah Rashid, Ph.D., Principal Scientist at KYAN, added: "It is scientifically recognized that epigenetic drugs, including HDACis, have significant cancer therapy potential but are limited in effectiveness as monotherapies. Utilizing Optim.AI, we have already pinpointed KYAN-001-based 2-drug or 3-drug combinations that outperform relapsed/refractory multiple myeloma standard of care therapies in in vitro efficacy. We also plan to interrogate combinations with drugs that are approved for other indications to identify even more optimal combinations that are nonobvious when relying on scientific rationale."

Lisa Chow further stated: "The beauty of applying Optim.AI to the development of KYAN-001 is that we will be able to cut costs and development time while also tackling unmet needs. Many programs are focused on biomarker discovery or subgrouping, which while important, tend to reduce the potential market size and leave many patients unaddressed. Optim.AI’s unique suite of proprietary analytics allows us to efficiently and accurately evaluate a vast number of combinations, an endeavor that would be prohibitively expensive and labor intensive via other methods. Therefore, we can find effective therapies for broader populations."

KYAN plans to explore at least four cancer indications for KYAN-001 and anticipates advancing KYAN-001 through to Phase I clinical trials by 2022.

On September 24, 2020 Innova Therapeutics Inc., a biopharmaceutical company committed to developing innovative cancer therapies for patients who have inadequate treatment options, reported that the FDA has granted Rare Pediatric Disease (RPD) Designation for IVT-8086 for the treatment of Osteosarcoma (OS) (Press release, Innova Therapeutics, SEP 24, 2020, View Source [SID1234565596]). IVT-8086 is a humanized monoclonal antibody (mAb) with high affinity to a novel anticancer target, secreted frizzled-related protein 2 (SFRP2).

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"The FDA’s Rare Pediatric Disease Designation of IVT-8086 for the treatment of osteosarcoma highlights the significant unmet medical needs for patients with this devastating and life-threatening disease. IVT-8086 has the potential to become the first FDA-approved therapy for individuals with osteosarcoma in over 30 years," said Robert Ryan, Ph.D., Chief Executive Officer of Innova Therapeutics.

This research was conducted in the laboratory at the Hollings Cancer Center at the Medical University of South Carolina (MUSC) by Nancy Klauber-DeMore, MD, who is a co-founder and Professor of Surgery and BMW Endowed Chair of Cancer Research.

Hollings Cancer Center Director Raymond N. DuBois, M.D., Ph.D. said, "This is very exciting for the cancer center. This is a new designation approved by the FDA for a terrible disease in children, osteosarcoma," DuBois said. "Hollings values these kinds of partnerships that help advance the great science happening here in our laboratories. Also, translating our basic science into the clinic is a major goal of Hollings, especially when there is such a great unmet need."

The FDA grants Rare Pediatric Disease Designation for serious and life-threatening diseases that primarily affect children ages 18 years or younger and fewer than 200,000 people in the U.S. If Innova’s new drug application ("NDA") for osteosarcoma is approved, Innova may receive a priority review voucher from the FDA, which can be redeemed to obtain priority review for any subsequent marketing application or may be sold to another company for their programs.

About Osteosarcoma

Osteosarcoma is a malignant bone tumor with histological findings of osteoid or bone production. OS is a highly metastatic cancer that predominantly affects children, teenagers, and young adults. In the last 20 years, OS patients have not seen improvement in prognosis even with available treatments. The prevalence of OS is approximately 40,000 individuals in the US.

About IVT-8086

IVT-8086 has high affinity to SFRP2, which is a novel anticancer therapeutic target that is highly expressed in OS tumor cells. IVT-8086 has been shown to antagonize SFRP2 thereby blocking the non-canonical Wnt/Ca2+ pathway, resulting in decreasing tumor cell angiogenesis and cell migration, increasing tumor cell apoptosis, and rescuing T cell exhaustion.

On September 24, 2020 IncellDx, Inc., a global leader in single-cell diagnostics, reported the USPTO has issued patent US10,782,298 to IncellDx. This patent covers a number of detection platforms including flow cytometry, single-cell imaging, and circulating tumor cell (CTC) instruments (Press release, IncellDx, SEP 24, 2020, View Source [SID1234565595]). Therapies directed at the PD-L1/PD-1 axis have revolutionized cancer immunotherapy and have contributed significantly to the reduction in deaths from cancer in the US over the past few years. The methods contained in this patent allow for PD-L1 quantification on a cell-by-cell basis based on simultaneous cell typing and even DNA content.

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"This is a major milestone for IncellDx as reflected by our development and commercialization of several immuno-oncology assays. These include our launch of the OncoTect iO Lung Cancer CE-IVD kit; our new RUO OncoTect iO Bladder Cancer Assay; and the impending submission of our OncoTect iO Bladder Cancer CE-IVD kit," said Dr. Bruce Patterson, CEO of IncellDx. "We look forward to launching more diagnostics in the immuno-oncology space in support of the ongoing research efforts and the rapidly expanding pipeline of drugs aimed at promoting immune responsiveness against cancer."