On November 12, 2020 BIOLASE, Inc. (NASDAQ: BIOL), the global leader in dental lasers, reported its financial results for the third quarter ended September 30, 2020 (Press release, Biolase Technology, NOV 12, 2020, View Source [SID1234570843]).

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Third Quarter 2020 Financial Highlights:

U.S. laser revenue increased 16% year over year
U.S. consumables and other revenue increased 25% year over year
New customers represented over 90% of U.S. laser sales in the quarter
Total revenue more than doubled sequentially, while down 24% year over year
Operating expenses decreased 24% year over year
Significantly strengthened balance sheet with an $18.0 million equity raise
"Our significantly improved third quarter revenue was driven by several factors, including 95% of dental offices having reopened in the United States, dental procedure levels having reached 70-80% of their pre-Covid-19 levels, and the fact that our product portfolio reduces the risk of infectious pathogens," said Todd Norbe, President and Chief Executive Officer. "Our Epic Hygiene dental laser meets the Centers for Disease Control and Prevention (CDC) guidelines to minimize the risk of COVID-19, while our all-tissue Waterlase dental lasers create 98% less aerosol than traditional dental handpieces, meeting the American Dental Association’s recommendation of reduced aerosol production to limit the spread of infectious pathogens, such as COVID-19. These unique attributes meet the rising needs of both dentists and patients as they look for solutions that allow them to provide and receive dental treatment in the safest way possible."

2020 Third Quarter Financial Results

Net revenue for the third quarter of 2020 was $6.5 million, an increase of 124% sequentially from second quarter revenue of $2.9 million, and a decrease of 24% compared to net revenue of $8.6 million for the third quarter of 2019. U.S. laser revenue was $2.7 million in the third quarter of 2020, up 16% when compared to U.S. laser revenue of $2.3 million for the third quarter of 2019. This increase is due to higher average selling prices in the third quarter of 2020 than in 2019. U.S. consumables and other revenue for the third quarter of 2020, which consists of revenue from consumable products such as disposable tips, increased 25% compared to the third quarter of 2019. Outside the U.S., laser revenue declined 64% to $1.0 million for the third quarter of 2020 compared to $2.8 million for the third quarter of 2019.

Gross margin for the third quarter of 2020 was 35%, compared to 34% for the third quarter of 2019. The higher gross margin reflects higher average U.S. selling prices of our lasers and a higher percentage of U.S. sales, partially offset by a decline in revenues relative to our fixed costs. Total operating expenses were $5.9 million for the third quarter of 2020 compared to $7.9 million for the third quarter of 2019, a decrease of approximately 24%. Operating loss for the third quarter of 2020 was $3.7 million, compared to an operating loss of $4.9 million in the third quarter of 2019, a decrease of 25% year over year. Net income for the third quarter of 2020 was $12,000 and less than $0.01 per share before a deemed dividend on preferred stock of $17.4 million, compared to a net loss of $5.5 million, or $0.25 per share, for the third quarter of 2019. Net loss after the deemed dividend was $17.4 million or $0.21 per share for the three months ended September 30, 2020.

Cash, cash equivalents, and restricted cash totaled $19.2 million as of September 30, 2020, and included proceeds from the rights offering completed in July.

Use of Non-GAAP Measures

The Reconciliation of GAAP Net Loss to Adjusted EBITDA at the end of this news release provides the details of the Company’s non-GAAP disclosures and the reconciliation of GAAP net loss and net loss per share to the Company’s Adjusted EBITDA and Adjusted EBITDA per share.

Adjusted EBITDA loss for the third quarter of 2020 was $2.5 million, or $0.03 per share, compared with Adjusted EBITDA loss of $2.7 million, or $0.12 per share, for the third quarter of 2019.

Conference Call Information

BIOLASE, Inc. will host a conference call today at 4:30 p.m. Eastern Time to discuss its operating results for the third quarter ended September 30, 2020, and to answer questions. For both "listen-only" participants and those participants who wish to take part in the question-and-answer portion of the call, the dial-in number in the U.S./Canada is 800-367-2403. For international participants outside the U.S./Canada, the dial-in number is 334-777-6978. For all callers, refer to the Conference ID 9286776. To access the live webcast, visit the Investor Relations section of the BIOLASE website at www.biolase.com and see "Investor Events".

An audio archive of the webcast will be available for 30 days on the Investor Relations section of the BIOLASE website.

On November 12, 2020 ThermoGenesis Holdings, Inc. (Nasdaq: THMO), a market leader in automated cell processing tools and services in the cell and gene therapy field, reported financial and operating results for the third quarter ended September 30, 2020 and provided a corporate update (Press release, Thermogenesis, NOV 12, 2020, View Source [SID1234570842]).

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Financial Results for the Quarter Ended September 30, 2020

Net Revenues. Consolidated net revenues for the three months ended September 30, 2020 were $2.4 million compared to $4.1 million for the three months ended September 30, 2019, a decrease of $1.7 million or 42%. The decrease was driven by lower AXP disposable and CAR-TXpress sales. The COVID-19 pandemic appears to be the main driver of the decline as fewer cord blood units are being stored globally during the pandemic. The Company expects sales to increase after the pandemic is over.

Gross Profit. The Company’s gross profit was $1.5 million or 64% of net revenues for the three months ended September 30, 2020, compared to $1.9 million or 47% of net revenues for the quarter ended September 30, 2019, a decrease of $0.4 million. The decrease was driven by the decline in AXP disposable and CAR-TXpress sales, partially offset by a refund of approximately $0.8 million from ImmuneCyte for its mark-up on sales of the testing kits which were previously reserved by the Company.

Sales and Marketing Expenses. Consolidated sales and marketing expenses were $539,000 for the three months ended September 30, 2020, as compared to $502,000 for the three months ended September 30, 2019, an increase of 7%. The increase was driven by accrued expenses related to the Company’s employee short-term incentive program and for consulting expenses. These increases were partially offset by lower stock compensation expense in the quarter ended September 30, 2020.

Research and Development Expenses. Consolidated research and development expenses were $750,000 for the three months ended September 30, 2020, compared to $584,000 for the three months ended September 30, 2019, an increase of $166,000 or 28%. The increase was driven by development expenses for the Company’s COVID-19 cartridge reader.

General and Administrative Expenses. Consolidated general and administrative expenses for the three months ended September 30, 2020 were $1.3 million, compared to $1.1 million for the three months ended September 30, 2019, an increase of $0.2 million or 15%. The primary driver of the increase was accrued expenses related to the Company’s employee short-term incentive program and severance expense.

Interest Expense. Interest expense for the three months ended September 30, 2020 was $1.5 million, compared to $1.2 million for the three months ended September 30, 2019, an increase of $0.3 million. The increase was driven by additional interest expense and amortization of the debt discount related to the Revolving Credit Agreement with Boyalife Asset Holding II, Inc.

Net Loss. For the quarter ended September 30, 2020, the Company reported a comprehensive loss attributable to common stockholders of $2.5 million, or $(0.37) per share, based on 6,711,664 weighted average basic and diluted common shares outstanding. This compares to a comprehensive net loss of $2.3 million, or $(0.78) per share, based on 2,913,198 weighted average basic and diluted common shares outstanding for the quarter ended September 30, 2019.

Adjusted EBITDA. In addition to the results reported under U.S. GAAP, the Company also uses a non-GAAP measure, adjusted EBITDA, to evaluate operating performance and to facilitate the comparison of its historical results and trends. The Company uses the metric to determine operational cash flow. Adjusted EBITDA for the three months ended September 30, 2020 was a loss of $672,000, compared to income of $125,000 for the three months ended September 30, 2019, a decrease of $797,000. The adjusted EBITDA decrease was driven by a reduction in gross profit as the result of lower sales, inventory reserves, accrued expenses related to the Company’s employee short-term incentive program, increased research and development expenses and severance expense. These decreases were partially offset by an $0.8 million refund received from ImmuneCyte for its mark-up portion of the testing kits previously reserved by the Company. A reconciliation of adjusted EBITDA to net loss is set forth below.

Liquidity and Capital Resources. At September 30, 2020, the Company had cash and cash equivalents totaling $4.4 million, compared with $3.2 million at December 31, 2019. Working capital improved to $7.1 million at September 30, 2020 as compared to $3.2 million at December 31, 2019.

Conference Call and Webcast Information
ThermoGenesis will host a conference call today at 1:30 p.m. PT/4:30 p.m. ET. To participate in the conference call, please dial 1-844-889-4331 (domestic), 1-412-380-7406 (international) or 1-866-605-3852 (Canada). To access a live webcast of the call, please visit: View Source

A webcast replay will also be available on ThermoGenesis’ website for three months, please visit: View Source

On November 12, 2020 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported that the Company will participate in a "fireside chat" presentation at the Jefferies Virtual London Healthcare Conference on Thursday, November 19, 2020 at 8:30am EST / 1:30pm GMT (Press release, Fusion Pharmaceuticals, NOV 12, 2020, View Source [SID1234570841]). Presenting on behalf of Fusion will be Chief Executive Officer John Valliant, Ph.D., Chief Financial Officer John Crowley, and Chief Medical Officer James O’Leary, M.D.

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A live webcast of the event will be available on the "Events and Presentations" page in the "Investors and Media" section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.

On November 12, 2020 Precision Optics Corporation, Inc. (OTCQB: PEYE), a leading designer and manufacturer of advanced optical instruments for the medical and defense industries, reported that operating results on an unaudited basis for its first quarter fiscal year ended September 30, 2020 (Press release, Precision Optics, NOV 12, 2020, View Source [SID1234570840]).

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First quarter fiscal 2021 highlights:

Revenue for the quarter ended September 30, 2020 was $2.76 million compared to $2.51 million in the same quarter of the previous fiscal year, an increase of 10%; and up 23% sequentially compared to $2.24 million in the fourth quarter of the previous fiscal year.
Gross margins for the quarter ended September 30, 2020 of 35% compared to 39% in the same quarter of the prior year; and compared to 29% for the quarter ended June 30, 2020.
Net income of $763 during the quarter included $71,146 of stock-based compensation. This compared to a loss of $86,110 in the same quarter a year ago and loss of $323,085 in the fourth quarter of fiscal 2020.
The Company’s cash position remains strong with an ending balance for the first quarter of $900,510.
Precision Optics’ CEO, Joseph Forkey, commented, "I am pleased with the operating performance during the first quarter which included a return to revenue growth. Our revenues grew sequentially by 23%, and by 10% year over year, as we saw a recovery in shipments on orders that had been delayed due to issues surrounding COVID-19 over the past few quarters. This growth in revenue, coupled with sequential improvement in gross margins and continued efficient management of expenses, lead to slight net income profitability and positive adjusted EBITDA. Importantly, our balance sheet remained strong with more than $900,000 in cash."

Dr. Forkey concluded, "Our team continues to maintain a safe overall workplace for our employees while meeting the expectations and demands of our customers. Production disruptions resulting from COVID-19 related precautions created a slightly elevated backlog going into the quarter, which we have largely now delivered. Importantly, COVID-19 did not materially alter end-market programs and we are seeing the progression of numerous pipeline projects that have the ability to be significant contributors to revenue over the next few quarters and years. We are still not out of the woods as it relates to the near term impacts from COVID-19 as customers work through excess inventory and evaluate the velocity of sell through of their end products in the market. However, the increase we have seen in pipeline projects as well as requests for quotation gives me optimism. We continue to have confidence that our existing production programs will ultimately return to pre-pandemic levels and combined with new programs that are building today, we expect to have a larger base of revenue. Our business today is inherently growing nicely."

The following table summarizes the first quarter (unaudited) results for the periods ended September 30, 2020 and 2019:

Conference Call Details
The Company has scheduled a conference call to discuss the first quarter 2021 financial results for Thursday, November 12, 2020 at 5:00 p.m. ET.

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 November 19, 2020 at (877) 344-7529 or (412) 317-0088, confirmation # 10149688. A webcast replay will be available at View Source

On November 12, 2020 VistaGen Therapeutics (NASDAQ: VTGN), a biopharmaceutical company developing new generation medicines for anxiety, depression and other central nervous system (CNS) disorders, reported its financial results for the fiscal 2021 second quarter ended September 30, 2020 and provided an update on its CNS pipeline and business progress (Press release, VistaGen Therapeutics, NOV 12, 2020, View Source [SID1234570839]).

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"We see a significant rise in mental health concerns as the global COVID-19 pandemic continues to impact the daily lives of millions of individuals. We are committed to developing innovative therapies that provide relief to those suffering from anxiety and depression, and we are working diligently towards that goal. We are making significant progress in preparing PH94B for launch of a pivotal Phase 3 study for acute treatment of anxiety in adults with social anxiety disorder in the second quarter of 2021. After reaching consensus with the FDA on the key components of the study design, it will be very similar to the statistically significant Phase 2 study of PH94B in social anxiety disorder. We are also working with the FDA to finalize details for our Phase 2A study of PH94B in adjustment disorder, which we are planning to initiate in early 2021," said Shawn Singh, Chief Executive Officer of VistaGen.

"Millions of people rely on benzodiazepines and other prescription drugs to manage symptoms of stress and anxiety. While some medications are safe and effective treatments, many in the current treatment paradigm have limited therapeutic benefits and potentially serious side effects and safety concerns. In Phase 2 clinical studies, PH94B produced rapid onset anti-anxiety effects without requiring systemic uptake and distribution. With its rapid-onset pharmacology, lack of systemic exposure and sedation, and its excellent safety profile in all studies to date, we believe PH94B has the potential to displace benzodiazepines in the drug treatment paradigm for anxiety disorders. In addition to social anxiety disorder, we believe PH94B also has potential as a novel treatment for adjustment disorder, postpartum anxiety, post-traumatic stress disorder, preprocedural anxiety, panic, and other anxiety-related disorders, and we look forward to assessing its potential in various controlled Phase 2 clinical studies in parallel with our Phase 3 program to assess its potential as an acute treatment of anxiety in adults with social anxiety disorder," concluded Mr. Singh.

CNS Pipeline Highlights and Updates:

PH94B

VistaGen reached consensus with the FDA on key study design and execution aspects of the Company’s initial pivotal Phase 3 study of PH94B for acute treatment of anxiety in adults with social anxiety disorder (SAD):
As in the statistically significant (p=0.002) Phase 2 public speaking study of PH94B in SAD, VistaGen’s Phase 3 study will involve a 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 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 subjects) will be approximately 182 adults with SAD.
Study expected to initiate recruitment in 2Q 2021.
VistaGen is currently preparing for an exploratory Phase 2A clinical study of PH94B for acute treatment of adjustment disorder (AjD), an emotional or behavioral reaction considered excessive or out of proportion to a stressful event or significant life change, occurring within three months of the stressor, and/or significantly impairing a person’s social, occupational and/or other important areas of functioning. Given the diverse impact of the COVID-19 pandemic, including, among other things, fear and anxiety about health and safety, economic loss, unemployment, social isolation, disruption of established education and work practices, VistaGen submitted its preliminary protocol for the study to the FDA through the FDA’s Coronavirus Treatment Acceleration Program (CTAP). Following that submission, the Company has continued its discussions with the FDA’s Division of Psychiatric Products to determine the study’s appropriate next steps, including the final study protocol.
The Company is planning to conduct the proposed Phase 2A study in New York City and enroll approximately 25 to 30 subjects suffering from adjustment disorder-provoking stressors, including, but not limited to, stressors related to the diverse impact of the COVID-19 pandemic and recent civil unrest in the U.S.
The AjD study is expected to initiate patient recruitment in 1Q 2021.
The Company is also planning for additional exploratory Phase 2A studies in postpartum anxiety, post-traumatic stress disorder, and pre-procedural anxiety (pre-MRI).
VistaGen reported new in vitro electrophysiology data demonstrating that the mechanism of action of PH94B, does not involve direct activation of GABA-A receptors, in distinct contrast to the mechanism of action of benzodiazepines, which act as direct positive modulators of GABA-A receptors.
These studies are significant because they indicate that PH94B has no relevant benzodiazepine-like activity, confirming PH94B’s potential to produce rapid-onset benzo-like, anti-anxiety effects, without the risky side effects and safety concerns of benzos.
AV-101

VistaGen reported positive new data from the Company’s second preclinical study of its oral investigational drug, AV-101, combined with probenecid, an FDA-approved drug for treatment of gout used adjunctively to increase the therapeutic benefit of numerous antibacterial, anticancer and antiviral drugs.
The results of this new study complement previous preclinical data demonstrating the combination’s potential to substantially increase the brain concentration of AV-101’s active metabolite, 7-Cl-KYN, a potent and selective full antagonist of the NMDA receptor glycine co-agonist site, thereby reducing, rather than blocking, NMDA receptor signaling.
Partnering Activity

VistaGen received a $5 million non-dilutive upfront license payment from EverInsight Therapeutics (now AffaMed Therapeutics), the Company’s strategic partner for Phase 3 development and commercialization of PH94B for anxiety-related disorders in key markets in Asia.
Upon successful development and commercialization of PH94B in the licensed territory, VistaGen is eligible to receive up to $172 million in additional development and commercial milestone payments, plus royalties on commercial sales of PH94B.
Capital Resources

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.
Financial Results for the Fiscal Quarter Ended September 30, 2020:

Net loss: Net loss attributable to common stockholders for the fiscal quarter ended September 30, 2020 decreased to approximately $3.7 million compared to $5.7 million for the fiscal quarter ended September 30, 2019. For the six-month period ending September 30, 2020, the net loss attributable to common stockholders was approximately $7.1 million, a decrease from approximately $12.2 million reported in the same period last year.

Revenue: Total revenue for the fiscal quarter ended September 30, 2020 was $334,000, representing the revenue recognition related to its agreement with EverInsight Therapeutics (now AffaMed Therapeutics), pursuant to which the Company received a non-dilutive upfront license fee payment of $5.0 million on August 3, 2020. VistaGen recognized $334,000 in sublicense revenue pursuant to this agreement in the six months ended September 30, 2020 compared to no revenue in the six months ended September 30, 2019. The Company expects to continue recognizing revenue pursuant to this payment in future periods during our fiscal year ending March 31, 2021 and thereafter.

Research and development (R&D) expense: Research and development expense decreased from $4.2 million in the quarter ended September 30, 2019 to $2.4 million for the quarter ended September 30, 2020. Research and development expense also decreased from $8.5 million to $4.1 million for the six months ended September 30, 2019 and 2020, respectively, in both cases, primarily due to the completion of the Company’s Phase 2 study of AV-101 as a potential adjunctive treatment of major depressive disorder in the fourth calendar quarter of 2019. Expenses related to that study and other nonclinical activities related to AV-101 decreased by $4.8 million for the six months ended September 30, 2020 compared to similar expense in the six months ended September 30, 2019. Noncash research and development expenses, primarily stock-based compensation and depreciation in both periods, accounted for approximately $391,000 and $607,000 in the six months ended September 30, 2020 and 2019, respectively.

General and administrative (G&A) expense: General and administrative expense totaled $1.3 million for the three months ended September 30, 2020 as compared to $1.2 million for the same period in the year prior. General and administrative expense decreased to approximately $2.7 million from approximately $3.1 million for the six months ended September 30, 2020 and 2019, respectively. Noncash general and administrative expense, $804,000 in the six months ended September 30, 2020, decreased from $1,044,000 in the six months ended September 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 equity securities granted to service providers.

Cash Position: At September 30, 2020, the Company had cash and cash equivalents of approximately $15.4 million. During the quarter ended September 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 (now AffaMed Therapeutics), and (ii) the gross proceeds of approximately $14.29 million from the sale of shares of its common stock in an underwritten public offering.

As of November 12, 2020, the Company had 73,998,057 shares of common stock outstanding.