On August 15, 2019 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported its financial results for the second quarter ended June 30, 2019 and provided an update on recent corporate developments (Press release, Bio-Path Holdings, AUG 15, 2019, View Source [SID1234538775]).

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"Throughout the second quarter we continued to execute on our clinical development plans for our innovative RNAi nanoparticle therapeutics. We are excited to begin dosing patients in the amended cohorts of our Phase 2 study of prexigebersen, which will first evaluate the safety of prexigebersen in combination with decitabine in untreated AML and high risk MDS patients and refractory/relapsed AML and high risk MDS patients, and then evaluate the efficacy of the triple combination of prexigebersen + decitabine + venetoclax in those patient groups," said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings.

"We are also looking forward to completing Investigational New Drug (IND) enabling studies of BP1003, a novel liposome-incorporated STAT3 oligodeoxynucleotide inhibitor for the treatment of pancreatic cancer, and to file an IND application for a Phase 1 study of BP1003 for the treatment of pancreatic cancer in 2020. We are particularly excited to launch this program as it will be our first-in-human validation of this cutting-edge therapy in an especially challenging cancer indication that has limited treatment options," added Mr. Nielsen.

Recent Corporate Highlights

Presented Preclinical Data at American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019. In April 2019, Bio-Path presented data from preclinical studies supporting the potential of BP1003, a novel liposome-incorporated STAT3 oligodeoxynucleotide inhibitor, for the treatment of pancreatic cancer, non-small cell lung cancer (NSCLC) and acute myelogenous leukemia (AML). These data were presented in a poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 in Atlanta, GA.
Financial Results for the Second Quarter Ended June 30, 2019

The Company reported a net loss of $2.5 million, or $0.87 per share, for the three months ended June 30, 2019, compared to a net loss of $1.7 million, or $2.96 per share, for the three months ended June 30, 2018.

Research and development expenses for the three months ended June 30, 2019 increased to $1.5 million, compared to $0.8 million for the three months ended June 30, 2018 primarily due to the commencement of activities related to Stage 2 of our Phase 2 clinical trial in AML to include venetoclax combination treatment with prexigebersen and two cohorts of patients.

General and administrative expenses for the three months ended June 30, 2019 increased to $1.0 million, compared to $0.9 million for the three months ended June 30, 2018 primarily due to increased legal fees and insurance costs.

As of June 30, 2019, the Company had cash of $17.1 million, compared to $1.0 million at December 31, 2018. Net cash used in operating activities for the six months ended June 30, 2019 was $4.2 million compared to $3.4 million for the comparable period in 2018. Net cash provided by financing activities for the six months ended June 30, 2019 was $20.3 million.
Conference Call and Webcast Information

Bio-Path Holdings will host a conference call and webcast today at 8:30 a.m. ET to review these second quarter 2019 financial results and to provide a general update on the Company. To access the conference call, please call (844) 815-4963 (domestic) or (210) 229-8838 (international) and refer to conference ID 3792557. A live audio webcast of the call and the archived webcast will be available in the Media section of the Company’s website at www.biopathholdings.com.

On August 15, 2019 Precision Optics Corporation, Inc. (OTCQB: PEYE), a leading designer and manufacturer of advanced optical instruments for the medical and defense industries, reported preliminary revenue for the fourth quarter and fiscal year end 2019, ended June 30, 2019 (Press release, Precision Optics, AUG 15, 2019, View Source [SID1234538792]). Additionally, the Company filed an 8-K/A which includes the pro forma financial results of its acquisition of Ross Optical Industries which was originally announced on July 8, 2019.

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Precision Optics will issue complete fiscal year end 2019 financial results as part of its Form 10-K to be filed during the last week of September 2019.

Preliminary fourth quarter fiscal 2019 highlights include:

Revenue for the quarter (ended June 30, 2019) from historical Precision Optics operations (ie. non-Ross Optical) are expected to be approximately $1.7 million, reflecting an increase of 16% compared to $1.5 million in the previous year’s fourth quarter and growth of 23% compared to the third quarter of fiscal 2019. Growth in revenue was driven primarily by an increase in production revenue to medical devices incorporating the Company’s Microprecision technology, including cardiovascular fiberscopes and an ENT scanning device.
In addition, the results of operations of Ross Optical beginning June 1, 2019 accrue to Precision Optics. Ross Optical’s sales for the month of June 2019 were approximately $650,000, bringing total fourth quarter revenue to approximately $2.4 million.
Preliminary fiscal year 2019 highlights include:

For the 2019 fiscal year (ended June 30, 2019), revenue from historical Precision Optics operations (ie. non-Ross Optical) are expected to be approximately $6.1 million, reflecting an increase of 52% compared to $4.0 million during fiscal year 2018.
Including the one month of contributions from Ross Optical, revenue for fiscal year 2019 is expected to be approximately $6.8 million, an increase of 68%.
Pro forma financial highlights include:

For the first 9 months of fiscal 2019 (ended March 31, 2019), pro forma financial results show a combined organization (Precision Optics and Ross Optical) with $7.4 million in sales, gross margin of approximately 35% and a net loss of $15,000. Non-cash stock-based compensation expenses of $356,000 during the nine months ended March 31, 2019 contributed to the loss for this period.
Precision Optics’ CEO, Joseph Forkey, commented, "I am extremely pleased with the preliminary revenue numbers for the fourth quarter and fiscal year 2019 which show a continuation of the strong growth trends we experienced throughout the year. Our work with key medical device and defense companies to help them develop the next generation of technology through Precision Optics’ proprietary micro optics and 3D imaging capabilities has created a growing portfolio of products. Many of these products should have long product life cycles, providing us with a strong and expanding backlog of business. Additionally, we have maintained strong engineering revenue levels, particularly for projects we expect to go into production during the next twelve to eighteen months."

Dr. Forkey continued, "To build on the growth in our micro optics and 3D imaging operations, we are excited about our recent acquisition of Ross Optical. Strategically, Ross Optical helps to broaden our markets and product offerings, enhances our supply chain, accelerates our efforts to gain economies of scale, and diversifies our customer concentration. Financially, we acquired a growing and profitable operation at what we believe is an attractive price with potential operational cost savings as well as key synergies available to us that further enhance the value to Precision Optics shareholders."

Preliminary Fourth Quarter 2019 Results and Ross Optical Acquisition Call Details
The Company has scheduled a conference call to discuss preliminary fourth quarter and fiscal 2019 revenues as well as its recent acquisition of Ross Optical Industries today, Thursday, August 15, 2019 at 5:00pm ET.

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 August 22, 2019 at (877) 344-7529 or (412) 317-0088, confirmation #10134182. A webcast replay will be at View Source

On August 15, 2019 Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (sd-rxRNA) therapeutic platform, reported that is has entered into a research collaboration with the Helmholtz Zentrum München (Press release, Phio Pharmaceuticals, AUG 15, 2019, View Source [SID1234538776]). The agreement covers the design and development of new targets based on Phio Pharmaceuticals’ proprietary self-delivering RNAi platform for use in cancer immunotherapies. This work will be performed at the Immunoanalytics Core Facility & research group under leadership of Prof. Dr. Elfriede Nößner and will complement Phio Pharmaceuticals’ internal research and development activities and collaborations with various other academic and industry partners.

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Dr. John A. Barrett, Chief Development Officer of Phio Pharmaceuticals, stated: "We are excited to be working with Dr. Nößner and her team who are experts in the study of lymphoid and myeloid effector cells and how to improve their contribution in overcoming tumor immunosuppression. In addition, the group has a successful track record of industry collaborations, thus the work will be of direct relevance for the development of the next generation therapeutics based on our self-delivering RNAi platform."

Prof. Dr. Elfriede Nößner, Head of Immunoanalytics at the Helmholtz Zentrum München, said: "Available data shows that Phio Pharmaceuticals’ self-delivering RNAi technology is ideally suited to inhibit checkpoints in immune effector cells such as T cells and NK cells in the microenvironment of solid tumors or inflammatory diseases. I look forward to working with the Phio team on targets beyond their interesting checkpoint-inhibiting self-delivering RNAi pipeline."

On August 15, 2019 Accuray Incorporated (NASDAQ: ARAY) reported financial results for the fourth quarter and fiscal year ended June 30, 2019 (Press release, Accuray, AUG 15, 2019, View Source [SID1234538793]).

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Q4 Fiscal 2019 and Recent Operating Highlights

Revenue increased 3 percent to $117.4 million, the highest ever quarterly revenue reported; Gross orders increased to $97.2 million
$3.3 million of operating profit, which grew 5 percent
Signed first multi-system order bundling Accuray and RaySearch Laboratories product and software offerings
Signed first upgrade order for Synchrony motion tracking and correction technology for Radixact
Fiscal Year 2019 Highlights

Gross orders increased 12 percent year-over-year to $342.3 million
Revenue increased 3 percent over the prior fiscal year to $418.8 million
Recorded first full year of operating profit since 2011
"From all perspectives, fiscal 2019 was a very successful year," said Joshua H. Levine, president and chief executive officer. "We generated 12 percent gross order growth for the year while our efforts to increase efficiencies led to the Company’s first operating profit since 2011. Additionally, we set a new quarterly revenue record during the fourth quarter. From a strategic growth perspective, we advanced our opportunities in China which is the world’s fastest growing radiotherapy market. It should be noted that our progress during fiscal 2019 came without significant revenue contribution from the China market as the process for awarding and issuing Class A and B user licenses for radiotherapy systems is still in an early phase."

Q4 Fiscal 2019 Financial Highlights

Gross product orders totaled $97.2 million for the fourth quarter of fiscal 2019 compared to $96.4 million for the prior fiscal year fourth quarter. Ending order backlog was $495.6 million, approximately 4 percent higher than at the end of the prior fiscal year.

Total revenue was $117.4 million, an increase of 3 percent compared to $113.8 million in the prior fiscal year fourth quarter. Product revenue totaled $60.6 million compared to $54.6 million in the prior fiscal year fourth quarter, while service revenue totaled $56.8 million compared to $59.2 million in the prior fiscal year fourth quarter.

Total gross profit for the fourth quarter of fiscal 2019 was $45.9 million or approximately 39.1 percent of sales, comprised of product gross margin of 40.7 percent and service gross margin of 37.4 percent. This compares to total gross profit of $48.0 million or 42.2 percent of sales, comprised of product gross margin of 47.4 percent and service gross margin of 37.4 percent for the prior fiscal year fourth quarter.

Net loss was $1.4 million, or $0.02 per share, for the fourth quarter of fiscal 2019, compared to a net loss of $0.9 million, or $0.01 per share, for the fourth quarter of fiscal 2018.

Adjusted EBITDA for the fourth quarter of fiscal 2019 was $8.9 million, compared to $7.8 million in the prior fiscal year fourth quarter.

Cash, cash equivalents, investments and short-term restricted cash were $87.0 million as of June 30, 2019, an increase of $22.4 million from March 31, 2019.

Fiscal Year 2019 Highlights

For the fiscal year ended June 30, 2019, gross product orders totaled $342.3 million, representing growth of 12 percent compared to the prior fiscal year period.

Total revenue was $418.8 million compared to $404.9 million in the prior fiscal year period. Product revenue totaled $196.7 million compared to $183.9 million in the prior fiscal year period, while service revenue totaled $222.1 million compared to $221.0 million from the prior fiscal year period.

Total gross profit for the year ended June 30, 2019 was $162.7 million or 38.8 percent of sales, comprised of product gross margin of 40.7 percent and service gross margin of 37.2 percent. This compares to total gross profit of $161.7 million or 39.9 percent of sales, comprised of product gross margin of 44.0 percent and service gross margin of 36.6 percent for the same prior fiscal year period.

Operating expenses were $162.1 million, a decrease of 2 percent compared to $165.5 million in the prior fiscal year period.

Net loss was $16.4 million, or $0.19 per share, for the fiscal year ended June 30, 2019, compared to a net loss of $23.9 million, or $0.28 per share, for the prior fiscal year period.

Adjusted EBITDA for the fiscal year ended June 30, 2019 was $23.7 million, compared to $17.1 million in the prior fiscal year period.

2020 Financial Guidance

The Company is introducing guidance for fiscal year 2020 as follows:

Total revenue is expected to range between $410.0 million to $420.0 million due to the expected delay in timing of Class A system revenue with total revenue during the first half of the year expected to be slightly below fiscal 2019 levels. The total revenue range includes the impact of 25% Chinese tariffs currently in place
Adjusted EBITDA is expected to range between $19.0 million to $24.0 million, including a loss of approximately $2 million from our China joint venture equity interest
Guidance for non-GAAP financial measures excludes depreciation and amortization, stock-based compensation expense, interest expense, net and provision for income taxes. For more information regarding the non-GAAP financial measures discussed in this press release, please see "Use of Non-GAAP Financial Measures" below.

Conference Call Information

Accuray will host a conference call beginning at 1:30 p.m. PT/4:30 p.m. ET today to discuss results for the fourth quarter and fiscal 2019 as well as recent corporate developments. Conference call dial-in information is as follows:

U.S. callers: (855) 867-4103
International callers: (262) 912-4764
Conference ID Number (U.S. and international): 3297842
Individuals interested in listening to the live conference call via the Internet may do so by logging on to Accuray’s website, www.accuray.com. In addition, a taped replay of the conference call will be available beginning approximately two hours after the call’s conclusion and available for seven days. The replay telephone number is (855) 859-2056 (USA) or (404) 537-3406 (International), Conference ID: 3297842. An archived webcast will also be available at Accuray’s website until Accuray announces its results for the first quarter of fiscal 2020.

Use of Non-GAAP Financial Measures

Accuray has supplemented its GAAP net loss with a non-GAAP measure of adjusted earnings before interest, taxes, depreciation, amortization and stock-based compensation ("adjusted EBITDA"). Management believes that this non-GAAP financial measure provides useful supplemental information to management and investors regarding the performance of the company and facilitates a meaningful comparison of results for current periods with previous operating results. A reconciliation of GAAP net loss (the most directly comparable GAAP measure) to non-GAAP adjusted EBITDA is provided in the schedule below.

There are limitations in using these non-GAAP financial measures because they are not prepared in accordance with GAAP and may be different from non-GAAP financial measures used by other companies. These non-GAAP financial measures should not be considered in isolation or as a substitute for GAAP financial measures. Investors and potential investors should consider non-GAAP financial measures only in conjunction with the company’s consolidated financial statements prepared in accordance with GAAP.

On August 15, 2019 Xynomic Pharmaceuticals Holdings, Inc. ("Xynomic", stock ticker: XYNO), a clinical stage U.S.-China oncology drug development company, reported that it has filed an application with the U.S. Food and Drug Administration ("U.S. FDA") seeking Fast-Track designation for its drug candidate abexinostat as a monotherapy for the treatment of relapsed or refractory follicular lymphoma ("r/r FL") (Press release, Xynomic Pharmaceuticals, AUG 15, 2019, View Source [SID1234538777]).

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Fast-Track designation is designed to aid in the development and expedite the review of drug candidates, which show promise in treating a serious or life-threatening disease, and address an unmet medical need. A drug candidate that receives Fast-Track designation is eligible for more frequent meetings and correspondences with the U.S. FDA and potential accelerated or priority review and more. The U.S. FDA will review the request and attempt to make a decision within 60 days.

According to Cancer.net, follicular lymphoma is the second most common form of lymphoma in the U.S. and Europe. Xynomic is conducting a Phase 2 trial to test abexinostat as a single agent in patients with r/r FL. Designed as a single arm trial, this trial will enroll approximately 120 patients in the U.S. and Europe who have undergone at least three lines of therapy to test abexinostat as a fourth line monotherapy.

The U.S. FDA has already granted Fast-Track designation to abexinostat, in combination with pazopanib, as a first- or second-line treatment of renal cell carcinoma ("RCC"). A global, randomized pivotal Phase 3 trial is underway to test abexinostat combined with pazopanib as a first- or second-line therapy in patients with locally advanced or metastatic RCC.

About Xynomic Pharmaceuticals Holdings, Inc.
Xynomic Pharmaceuticals Holdings, Inc. is a clinical stage oncology-focused biopharmaceutical company. Its current pipeline mainly consists of 3 drug candidates; Xynomic owns global exclusive development, manufacturing and commercialization rights to each of these. Its lead drug candidate abexinostat is in global potentially pivotal clinical trials against renal cell carcinoma (in combination with pazopanib) and non-Hodgkin’s lymphoma (as a single agent). Xynomic’s XP-105 (BI 860585) is a Phase 2 ready, ATP-competitive mTORC1/2 inhibitor against solid tumors. Xynomic’s XP-102 (BI 882370) is a Phase 1 ready pan-RAF inhibitor.

Use of Forward-Looking Statements

This press release contains "forward-looking" statements made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "should," "expects," "plans," "anticipates," "could," "intends," "target," "projects," "contemplates," "believes," "estimates," "predicts," "potential," or "continue," or the negative of these terms or other similar expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause