On August 13, 2020 Seneca Biopharma, Inc. (Nasdaq: SNCA), a biopharmaceutical company focused on developing novel treatments for diseases of high unmet medical need, today reported its financial results for the quarter ended June 30, 2020 (Press release, Seneca Biopharma, AUG 13, 2020, View Source [SID1234563615]).

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Business Highlights for 2020 to date.

During the First Half of 2020, the Company achieved the following business milestones:

Completed offerings resulting in net proceeds of over $14.8 million.
Continued progress on both the Company’s out-licensing effort to partner NSI-566 and NSI-189 programs and initiative to in-license or acquire novel therapeutics.
Appointed of Matthew W. Kalnik, Ph.D. as President and Chief Operating Officer and Dane R. Saglio as Chief Financial Officer.
Affirmed guidance that data readout from the Company’s non-GCP Phase II trial evaluating NSI-566, for the treatment of chronic ischemic stroke, is expected during the second half of 2020.
Announced that as a result of feedback received from the FDA, Seneca believes that the existing Phase 1 and 2 trial results support moving into a Phase 3 clinical study for ALS.
Completion of the Company’s stem cell manufacturing facility in Suzhou, China which will be used to manufacture NSI-566 for clinical trials within China.
Financial Results for the Quarter Ended June 30, 2020

Cash Position and Liquidity: At June 30, 2020, cash was approximately $15.8 million as compared to approximately $10 million at March 31, 2020. The increase in cash is attributed to the May 2020 warrant exercises and registered direct offering.

Operating Loss: Operating loss for the quarter ended June 30, 2020 was $1.9 million compared to a loss of $1.9 million for the comparable 2019 period. For the six-month period ended June 30, 2020, the operating loss was $3.9 million versus $4.4 million for the six months ended June 30, 2019. The decrease in operating loss for 2020 was primarily due to a decrease in R&D expenses as we continue to wind down the clinical programs. This decrease was partially offset by an increase in G&A expenses which reflects an enhanced management structure to support corporate objectives as compared to the same period of 2019.

Net Loss: Net loss for the quarter ended June 30, 2020 was $2.0 million, or $0.15 per share, compared to a loss of $1.4 million, or $1.45 per share on a post-reverse stock-split basis, for the same period in 2019. For the 2020 six-month period the net loss was $9.5 million, or $0.92 per share versus a net loss of $4.6 million, or $4.78 per share for the same period in 2019. The 2020 increase in net loss was primarily attributed to a non-cash expense of $5.6 million related to the January 2020 warrant inducement transaction.

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.