On August 13, 2020 Strata Oncology, Inc., a precision oncology company advancing molecular indications for cancer therapies, reported it has signed an agreement with Mirati Therapeutics, Inc. (NASDAQ:MRTX) to broaden patient identification and enrollment for Mirati’s Phase 1/2 study of MRTX849 in patients with cancer having a KRAS G12C mutation (clinicaltrials.gov identifier: NCT03785249) (Press release, Strata Oncology, AUG 13, 2020, View Source [SID1234563614]). The multiple expansion cohort study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 in patients with advanced solid tumors who have a KRAS G12C mutation.

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Under the terms of the agreement and through the Strata Trial, Strata Oncology will identify patients with advanced solid tumors who have a KRAS G12C mutation and meet other eligibility criteria, to be considered for enrollment into Mirati’s Phase 1/2 study, MRTX849-001 a G12C selective inhibitor. The Strata Trial, an ongoing observational study providing tumor molecular profiling for patients with advanced cancer paired with a portfolio of biomarker-guided clinical trials, is available across a network of 20+ select health systems nationwide. Through the Strata Trial, patients with advanced cancer are profiled using StrataNGSTM, a comprehensive molecular profiling test optimized for performance on tumor tissue samples as small as 0.5mm2 surface area.

"Our partnership with Mirati Therapeutics is reflective of our shared goal to develop new medicines not by tissue type but by molecular profile, producing superior outcomes for patients and potentially faster drug approvals," said Dan Rhodes, Ph.D., CEO of Strata Oncology. "We are confident our network of health systems, standardized on the Strata Trial, will bring additional support to help broaden enrollment of this important clinical trial."

For more information about the trial, please visit View Source

On August 13, 2020 Accuray Incorporated (NASDAQ: ARAY) reported financial results for the fourth quarter and fiscal year ended June 30, 2020 (Press release, Accuray, AUG 13, 2020, View Source [SID1234563613]).

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Q4 Fiscal 2020 and Recent Operating Highlights

Gross orders of $94.3 million, including 8 orders from China
Net revenue of $95.0 million, net loss of $0.8 million, Adjusted EBITDA of $9.3 million
Generated $19.2 million of operating cash flow and ended the quarter with $108.6 million of cash and short-term restricted cash
Shipped nine Synchrony upgrades
Fiscal Year 2020 Highlights

Gross orders increased 10 percent to $377.3 million versus prior fiscal year
Ending backlog of $602.7 million, an increase of 22 percent from June 30, 2019
Robust demand for Synchrony on Radixact: 56 global orders and 16 total shipments since commercial release
Net revenue of $382.9 million, net income of $3.2 million, Adjusted EBITDA grew to $26.8 million from $23.7 million in prior fiscal year
GAAP operating income grew to $11.9 million from $0.6 million in prior fiscal year
"Despite the circumstances and the uncertainties associated with the COVID-19 pandemic, we finished fiscal 2020 with a solid performance and grew our gross orders by 10 percent year over year," said Josh Levine, president and chief executive officer of Accuray. "I am proud of the team’s execution during the quarter, especially given the challenging operating environment created by the pandemic. We saw strong operating cash flow generation during the quarter and exited the quarter with $108.6 million of cash and short-term restricted cash as we continue to focus on operating efficiencies and working capital management. We believe that our operational focus, joint venture strategy in China, and continued investments in our value creating R&D pipeline projects, positions Accuray strongly for the future."

Q4 Fiscal 2020 Financial Highlights

Gross product orders totaled $94.3 million for the fourth quarter of fiscal 2020 compared to $97.2 million for the prior fiscal year fourth quarter. Ending order backlog was $602.7 million, approximately 22 percent higher than at the end of the prior fiscal year.

Total revenue was $95.0 million for the fourth quarter of fiscal 2020 compared to $117.4 million for the prior fiscal year fourth quarter. Product revenue totaled $40.4 million compared to $60.6 million for the prior fiscal year fourth quarter, while service revenue totaled $54.6 million compared to $56.8 million for the prior fiscal year fourth quarter.

Total gross profit for the fourth quarter of fiscal 2020 was $39.9 million or approximately 42.0 percent of sales, comprised of product gross margin of 45.0 percent and service gross margin of 39.8 percent. This compares to total gross profit of $45.9 million or 39.1 percent of sales, comprised of product gross margin of 40.7 percent and service gross margin of 37.4 percent for the prior fiscal year fourth quarter.

Net loss was $0.8 million, or $0.01 per share, for the fourth quarter of fiscal 2020, compared to a net loss of $1.4 million, or $0.02 per share, for the prior fiscal year fourth quarter.

Adjusted EBITDA for the fourth quarter of fiscal 2020 was $9.3 million, compared to $8.9 million for the prior fiscal year fourth quarter.

Cash, cash equivalents, and short-term restricted cash were $108.6 million as of June 30, 2020, an increase of $17.0 million from March 31, 2020.

Fiscal Year 2020 Highlights

For the fiscal year ended June 30, 2020, gross product orders totaled $377.3 million, representing growth of 10.2 percent compared to the prior fiscal year period.

Total revenue was $382.9 million for the fiscal year ended June 30, 2020 compared to $418.8 million for the prior fiscal year period. Product revenue totaled $167.3 million compared to $196.7 million for the prior fiscal year period, while service revenue totaled $215.6 million compared to $222.1 million for the prior fiscal year period.

Total gross profit for the year ended June 30, 2020 was $149.9 million or 39.1 percent of sales, comprised of product gross margin of 42.7 percent and service gross margin of 36.4 percent. This compares to total gross profit of $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 for the prior fiscal year period.

Operating expenses were $138.0 million, a decrease of 14.9 percent compared to $162.1 million for the prior fiscal year period.

Net income was $3.2 million, or $0.04 per share, basic, for the fiscal year ended June 30, 2020, compared to a net loss of $16.4 million, or $0.19 per share, basic, for the prior fiscal year period. Net income included a non-cash, special gain of $13.0 million related to the value of the company’s capital contribution to its China joint venture in exchange for the company’s 49% equity interest in the joint venture. This gain was recorded as non-operating, other income in the second quarter of fiscal 2020.

Adjusted EBITDA for the fiscal year ended June 30, 2020 was $26.8 million, compared to $23.7 million for the prior fiscal year period.

Financial Guidance

The impact of the COVID-19 pandemic on Accuray’s fiscal 2021 results remains uncertain. Given the continued evolution of the COVID-19 pandemic and the uncertainty surrounding its impact on the global economy and the healthcare industry, Accuray believes it is prudent to refrain from providing revenue and adjusted EBITDA guidance for fiscal year 2021. The company is carefully monitoring the pandemic and the impact on its business; however, given the uncertainty regarding the pandemic’s spread, duration, and impact, the company is currently unable to predict the extent to which the COVID-19 pandemic will impact its future operations and financial results.

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 2020 as well as recent corporate developments. Conference call dial-in information is as follows:

U.S. callers: (877) 270-2148
International callers: (412) 902-6510
Individuals interested in listening to the live conference call via the Internet may do so by logging on to the Investor Relations section of Accuray’s website, www.accuray.com. There will be a slide presentation accompanying today’s event which can also be accessed on the Company’s Investor Relations page at www.accuray.com.

In addition, a taped replay of the conference call will be available beginning approximately one hour after the call’s conclusion and available for seven days. The replay telephone number is (877) 344-7529 (USA) or (412) 317-0088 (International), Conference ID:10146316. An archived webcast will also be available at Accuray’s website until Accuray announces its results for the first quarter of fiscal 2021.

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"). The calculation of adjusted EBITDA also excludes certain non-recurring, irregular and one-time items, including the non-cash, special gain related to Accuray’s capital contribution to the China joint venture, an accounts receivable impairment charge, costs associated with reduction of staff and a non-cash reversal of deferred rent related to a lease termination. 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 income (loss) (the most directly comparable GAAP measure) to non-GAAP adjusted EBITDA is provided in the schedules 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 13, 2020 Palatin Technologies, Inc. (NYSE American: PTN), a specialized biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems, reported that it participated in Canaccord Genuity’s 40th Annual Growth Conference in a Fireside Chat today at 10:30 am ET (Press release, Palatin Technologies, AUG 13, 2020, View Source [SID1234563612]). The conference was held virtually.

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Carl Spana, Ph.D., President and Chief Executive Officer and Stephen T. Wills, Chief Financial Officer and Chief Operating Officer of Palatin Technologies, participated in the Fireside Chat hosted by John Newman of Canaccord Genuity.

The Fireside Chat was webcast. The webcast replay can be accessed by logging on to the "Investor/Webcasts" section of Palatin’s website at View Source or by clicking the following link: View Source The webcast will be available for 90 days.

On August 13, 2020 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 2020, ended June 30, 2020 (Press release, Precision Optics, AUG 13, 2020, View Source [SID1234563611]).

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Precision Optics will issue complete fiscal year end 2020 financial results as part of its Form 10-K to be filed during the last week of September 2020.

Preliminary fourth quarter and fiscal year 2020 (ended June 30, 2020) highlights include:

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.
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.
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.
Precision Optics’ CEO, Joseph Forkey, commented, "Despite the impacts from COVID-19, we completed the fiscal year with good revenue and a strong cash balance as we continue to benefit from the addition of Ross Optical and the strength of some of our pipeline projects. Our three recently commercialized production programs all continue at levels similar to recent months. All of our employees continue to work diligently to limit the impact of COVID-19 on our existing operations and to aggressively pursue new project pipeline opportunities."

Dr. Forkey continued, "Although COVID-19 has had a significant impact on the overall economy, the markets we serve remain generally solid. We believe medical devices and defense / aerospace, our primary markets, are among the most economically resilient and vibrant industries to be selling into. The pandemic impacts our business in a few ways: by slowing the sales cycle, slowing production orders of existing clients, and impacting efficiency which adds costs. A few of our prospective partners have slowed development as they adjust to changes in their rollout strategies. For example, one pipeline project for a 3D endoscope for robotic surgery, was recently placed on hold by our customer. However, other pipeline projects are moving along on track, and we are pursuing several ongoing and new opportunities, some with significant revenue potential. I am pleased, in particular, to see opportunities we are pursuing as a combined Precision Optics and Ross Optical team. Recently we began prototype deliveries for a new defense / aerospace customer that we added to our project pipeline through our combined efforts. We do not yet know the long-term potential of this new project but the success of the Ross Optical and Precision Optics teams working together is a strong indicator of future potential to grow our project pipeline."

"I am proud of the accomplishments made by our team in the face of various impacts from COVID-19 on our business. Our recent short-term operations have been negatively impacted by supply chain issues, lower labor efficiency and higher resulting costs, but these impacts are now subsiding. We remain committed to our overall strategic operating plan and believe Precision Optics continues to be well positioned to drive significant long-term value," concluded Dr. Forkey.

On August 13, 2020 VistaGen Therapeutics, Inc. (Nasdaq: VTGN), a biopharmaceutical company developing new generation medicines for anxiety, depression and other central nervous system (CNS) disorders, reported financial results for its fiscal 2021 first quarter ended June 30, 2020 (Press release, VistaGen Therapeutics, AUG 13, 2020, View Source [SID1234563610]).

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"We accomplished several meaningful milestones thus far this fiscal year that positively impact our clinical development programs, including our PH94B Phase 3 program in social anxiety disorder. We reached consensus with the FDA on the key aspects of the design of our pivotal Phase 3 clinical studies of PH94B for acute treatment of anxiety in adults with social anxiety disorder. This design is similar to the design of the highly statistically significant Phase 2 study of PH94B in social anxiety disorder," said Shawn Singh, Chief Executive Officer of VistaGen. "Additionally, we received the $5 million upfront license payment from our partnering arrangement with EverInsight Therapeutics for Phase 3 development and commercialization of PH94B in key markets in Asia. We also completed a successful public offering of our common stock, resulting in gross proceeds to us of $14.29 million. These accomplishments significantly strengthen our go-forward development plans. We believe now more than ever; the global society needs new, safe, fast-acting treatments for anxiety and depression and we remain committed to achieving that goal."

Financial Highlights During and Subsequent to the Fiscal 2021 First Quarter:

VistaGen received a $5 million non-dilutive upfront license payment from EverInsight Therapeutics, the Company’s strategic partner for Phase 3 development and commercialization of PH94B for anxiety-related disorders in multiple key markets in Asia.
VistaGen completed an underwritten public offering of common stock resulting in gross proceeds of $14.29 million to the Company, before underwriting discounts and commissions and offering expenses.
CNS Pipeline Highlights:

VistaGen reached consensus with the FDA on key aspects regarding the Company’s initial pivotal Phase 3 study of PH94B for acute treatment of anxiety in adults with social anxiety disorder (SAD) that, among other details, may provide significant time- and cost-efficiencies for its Phase 3 program.
As in the highly statistically significant (p=0.002) Phase 2 study of PH94B in SAD, VistaGen’s Phase 3 study will involve a single laboratory-simulated anxiety-provoking public speaking challenge.
The Phase 3 study will be a randomized, double-blind, placebo-controlled, parallel comparison study conducted at approximately 12 to 15 sites in North America.
The Subjective Units of Distress Scale (SUDS) will be used to assess the primary efficacy endpoint in the study.
Dr. Michael Liebowitz, Professor of Clinical Psychiatry at Columbia University, director of the Medical Research Network in New York City, and creator of the Liebowitz Social Anxiety Scale (LSAS), will be the Principal Investigator of the study.
Target enrollment (completed patients) will be approximately 182 adult patients with SAD.
Through the FDA’s Coronavirus Treatment Acceleration Program (CTAP), VistaGen submitted its preliminary protocol and development plan for an exploratory, open-label Phase 2A study of PH94B for acute treatment of adjustment disorder with anxiety (AjDA), including, but not limited to, anxiety-provoking stressors related to the diverse impact of the COVID-19 pandemic (e.g., fear and anxiety regarding health and safety, economic loss, unemployment, social isolation, distance-learning, etc.) and civil unrest.
The Company is currently working closely with the FDA on plans for the Phase 2A study in AjDA, which, when study preparations are completed, will be conducted in New York City by Dr. Michael Liebowitz.
Financial Results for the Fiscal Quarter Ended June 30, 2020:

Net loss: Net loss attributable to common stockholders for the fiscal quarter ended June 30, 2020 decreased to approximately $3.5 million compared to $6.5 million for the fiscal quarter ended June 30, 2019.

Research and development (R&D) expense: R&D expense decreased to approximately $1.7 million from $4.3 million for the quarters ended June 30, 2020 and 2019, respectively, primarily due to the completion of our Phase 2 study of AV-101 in major depressive disorder in the fourth calendar quarter of 2019. Expenses related to that study and other AV-101 related nonclinical activities decreased by $2.5 million in the quarter ended June 30, 2020 compared to expense in the quarter ended June 30, 2019. Noncash research and development expenses, primarily stock-based compensation, and depreciation in both periods, accounted for approximately $249,000 and $416,000 in the quarters ended June 30, 2020 and 2019, respectively.

General and administrative (G&A) expense: G&A expense decreased to approximately $1.4 million from approximately $1.9 million for the quarters ended June 30, 2020 and 2019, respectively. Noncash G&A expense, $466,000 in the quarter ended June 30, 2020, decreased from $772,000 in the quarter ended June 30, 2019, primarily due to decreases in stock-based compensation and the noncash components of investor and public relations expense attributable to the amortization of the fair value of common stock or warrants granted to service providers.

Cash Position: At June 30, 2020, VistaGen had cash and cash equivalents of $1.5 million, compared to $1.4 million at March 31, 2020. After June 30, 2020, the Company received net proceeds totaling approximately $17.5 million from (i) the $5.0 million gross non-dilutive upfront license fee payment from EverInsight Therapeutics, Inc. pursuant our PH94B strategic collaboration agreement for development and commercialization of PH94B in key markets in Asia, and (ii) the gross proceeds of approximately $14.29 million from the sale of shares of common stock in the underwritten public offering.

As of August 13, 2020, there were 77,998,057 shares of common stock outstanding.

About PH94B
PH94B is a rapid-onset (within approximately 15 minutes) synthetic neurosteroid nasal spray with therapeutic potential across a broad range of anxiety-related disorders. Easily self-administered in microgram-level doses, PH94B does not require systemic uptake and distribution to produce its rapid-onset anti-anxiety effects.

VistaGen is preparing for Phase 3 clinical development of PH94B as a potential new generation fast-acting, non-sedating, non-addictive acute treatment of anxiety in adults with social anxiety disorder (SAD). The FDA has granted Fast Track designation for development of PH94B for this indication, believed to be the first such designation by the FDA for a drug candidate for SAD.

With its rapid-onset pharmacology, lack of systemic exposure and excellent safety profile in earlier studies, PH94B has potential as a novel treatment for multiple additional anxiety-related disorders. VistaGen is also preparing for exploratory Phase 2A development of PH94B for acute treatment of adjustment disorder. View more background information on SAD and a video on PH94B’s mechanism of action.

About PH10
PH10 is an investigational synthetic neurosteroid with therapeutic potential in a wide range of neuropsychiatric indications involving depression and suicidal ideation. VistaGen is initially developing PH10 as a potential fast-acting, non-sedating, non-addictive new generation stand-alone treatment of major depressive disorder (MDD). Following successfully completed Phase 2A development for MDD, VistaGen is now preparing for Phase 2B clinical development of PH10 for MDD.

About AV-101
AV-101 (4-Cl-KYN) targets the NMDAR (N-methyl-D-aspartate receptor), an ionotropic glutamate receptor in the brain. Abnormal NMDAR function is associated with numerous CNS diseases and disorders. AV-101 is an oral prodrug of 7-chlorokynurenic acid (7-Cl-KYNA), which is a potent and selective full antagonist of the glycine co-agonist site of the NMDAR that inhibits the function of the NMDAR. Unlike ketamine and other NMDAR antagonists, 7-Cl-KYNA is not an ion channel blocker. In all studies to date, AV-101 has exhibited no dissociative or hallucinogenic psychological side effects or safety concerns similar to those that may be caused by amantadine, esketamine and ketamine. With its exceptionally few side effects and excellent safety profile, AV-101 has potential to be an oral new generation treatment for multiple CNS indications. The FDA has granted Fast Track designation for development of AV-101 as both a potential adjunctive treatment for MDD and as a non-opioid treatment for neuropathic pain.