On May 11, 2020 DURECT Corporation (Nasdaq: DRRX) reported financial results for the three months ended March 31, 2020 and provided a corporate update (Press release, DURECT, MAY 11, 2020, View Source [SID1234557507]).

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Total revenues were $2.8 million and net loss was $9.9 million for the three months ended March 31, 2020 as compared to total revenues of $4.1 million and net loss of $7.1 million for the three months ended March 31, 2019.

At March 31, 2020, cash and investments were $52.5 million, compared to cash and investments of $64.8 million at December 31, 2019. Debt at March 31, 2020 was $20.4 million, compared to $20.3 million at December 31, 2019.

"We are pleased to be working with the FDA on the design of a double-blind, multi-center, placebo-controlled clinical study to evaluate the safety and efficacy of DUR-928 in COVID-19 patients with acute liver or kidney injury," stated James E. Brown, D.V.M., President and CEO of DURECT. "The first quarter was largely about adjusting to the challenges posed by the COVID-19 pandemic and planning our next clinical study of DUR-928 in alcoholic hepatitis, while continuing to make progress on our other key programs. In addition to initiating discussions with the FDA regarding the potential use of DUR-928 in COVID-19 patients, we were fortunate during Q1 to be able to complete enrollment in our NASH trial and respond to several information requests from the FDA as they continue their review of our New Drug Application (NDA) for POSIMIR."

Update on Selected Programs:

Epigenetic Regulator Program. DUR-928, the lead product candidate in the Company’s Epigenetic Regulator Program, is an endogenous, orally bioavailable, first-in-class small molecule, which may have broad applicability in acute organ injuries such as alcoholic hepatitis (AH) and COVID-19 patients with acute liver or kidney injury as well as in chronic liver diseases such as non-alcoholic steatohepatitis (NASH).

Clinical Trials

COVID-19

We are working with the FDA on the design of a double-blind, placebo-controlled, multi-center, proof-of-concept Phase 2 study to evaluate the safety and efficacy of DUR-928 in approximately 80 COVID-19 patients with acute liver or kidney injury.

Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus (SARS-COV-2). The rapid spread of the disease has resulted in a pandemic with more than 4 million confirmed cases and over 280,000 deaths worldwide, over 79,000 of which have occurred in the United States as of this writing. While most cases result in mild symptoms, including fever, cough and shortness of breath, some progress into severe pneumonia and multi-organ failure, potentially as a result of severe immune overreaction (a cytokine storm), or as a result of ischemic injury, or other complications. Several studies reported that up to half of hospitalized patients with COVID-19 had elevated liver enzyme levels that signal liver injury and more than a third of hospitalized patients had kidney damage.

The reasons for potentially testing DUR-928 in this patient population include:

DUR-928 has demonstrated, both in vitro and in vivo, its ability to stabilize mitochondria, modulate inflammatory responses, and promote cell survival and tissue regeneration, which may render it to be effective in preventing or treating acute organ injury.

Patients with severe COVID-19 can develop multi-organ injury, including acute kidney, liver and/or cardiac injury, in addition to lung injury and acute respiratory distress syndrome (ARDS). Therefore, one could potentially save lives of those hospitalized patients with COVID-19 if one could prevent or treat acute organ injury by alleviating acute cell injury, regulating inflammation, promoting cell survival, and stimulating tissue regeneration.

Acute liver or kidney injury is a risk factor for poor outcomes in COVID-19 patients. These patients are being excluded from many ongoing anti-viral COVID-19 trials and are in great need of a new therapy.

Most relevant to COVID-19 patients with acute liver or kidney injury are results from the recently completed Phase 2a study in AH patients (see below). All 19 patients dosed with DUR-928 survived the 28-day study, while the historical 28-day mortality rate in AH patients is 26% on average.

To date, DUR-928 has been dosed in more than 280 subjects, both healthy volunteers and patients, in multiple Phase 1 and 2 studies and has been well tolerated. No serious adverse events have been associated with the drug.

Alcoholic Hepatitis (AH)

During 2019, we completed a Phase 2a clinical trial of DUR-928 in patients with AH. All 19 patients treated with DUR-928 in the AH trial survived the 28-day follow-up period and there were no drug-related serious adverse events. The study results were presented as a late-breaking oral presentation at The Liver Meeting 2019 by Dr. Tarek Hassanein, one of the trial’s principal investigators. In a separate poster presentation, Dr. Craig McClain presented additional comparative data from the Phase 2a clinical trial of DUR-928 and a control group of severe AH patients treated with corticosteroids in a contemporaneous AH trial conducted at University of Louisville. Additionally, the DUR-928 results were selected for inclusion in the "Best of The Liver Meeting" summary slide deck in the Alcohol-related Liver Disease category. Inclusion in this slide deck is considered a singular honor and indicates the high level with which the AASLD review committee regarded this study.

AH is an acute form of alcoholic liver disease (ALD) associated with long-term heavy intake of alcohol, and often occurs after a recent period of increased alcohol consumption. AH is typically characterized by recent onset jaundice and hepatic failure. An analysis of 77 studies published between 1971 and 2016, which included data from a total of 8,184 patients, showed the overall mortality from AH was 26% at 28 days. According to the most recent data provided by the Agency for Healthcare Research and Quality (AHRQ), a part of the US Department of Health and Human Services (HHS), there were over 117,000 hospitalizations for patients with AH in 2016. From a recent publication analyzing the mortality and costs associated with AH, the cost per patient is estimated at over $50,000 in the first year. ALD is one of the leading causes of liver transplants in the U.S., costing over $800,000 per patient.

We are working with the FDA and our advisors to finalize the design of a multi-center, international, randomized, double blind, placebo-controlled Phase 2b clinical trial of DUR-928 in severe AH patients. Patients in the trial will be randomized to receive 30 mg of DUR-928, 90 mg of DUR-928 or placebo. The primary goal of the trial will be to demonstrate a superior survival rate for patients treated with DUR-928 compared to those treated with placebo. Further details of the trial design, including the size of the trial and details on the endpoints will be provided at a future date. Due to the COVID-19 pandemic, we are updating our guidance for initiation of this trial and now expect the trial to begin enrolling patients in the second half of 2020.

Non-Alcoholic Steatohepatitis (NASH)

We have completed enrollment in the ongoing NASH trial. 62 patients have completed dosing and their final visits. Clinical data from the last few patients are being collected, while only a few were unable to complete final visits due to COVID-19 related office closings and travel restrictions. The Company remains on track to announce top-line study results mid-year.

The trial is a Phase 1b randomized and open-label clinical study conducted in the U.S. to evaluate safety, pharmacokinetics and signals of biological activity (including clinical chemistry and biomarkers as well as liver fat content and liver stiffness by imaging) of DUR-928 in NASH patients with stage 1-3 fibrosis. DUR-928 (at doses of 50 mg QD, 150 mg QD or 300 mg BID) is administered orally for 28 consecutive days and patients are followed up for an additional 28 days.

Non-alcoholic fatty liver disease (NAFLD) is the most common form of chronic liver disease in both children and adults. It is estimated that NAFLD affects approximately 30% to 40% of adults and 10% of children in the United States. NASH, a more severe and progressive form of NAFLD, is one of the most common chronic liver diseases worldwide, with an estimated prevalence of 3-5% globally. No drug is currently approved for NAFLD or NASH.

POSIMIR (bupivacaine extended-release solution) Post-Operative Pain Relief Depot. POSIMIR is the Company’s investigational post-operative pain relief depot that uses the Company’s patented SABER technology and is designed to deliver bupivacaine to provide up to 3 days of pain relief after surgery.

Since the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) meeting on January 16, 2020, we have continued to interact with the FDA as they continue their review of the POSIMIR NDA.

The efforts to evaluate the program, develop a strategy for filing the response to the Complete Response Letter (CRL), and preparing the response, have been under the direction of Dr. Lee Simon, who was formerly the FDA’s Division Director of Analgesic, Anti-inflammatory and Ophthalmologic Drug Products. Dr. Simon also led our preparation efforts for the Advisory Committee meeting.

POSIMIR has not been approved by the FDA for marketing in the U.S. or elsewhere for any indication and there can be no assurance that the FDA will approve the submission described above.

Conference Call

We will host a conference call today at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time to discuss first quarter 2020 results and provide a corporate update:

Monday May 11th @ 4:30pm Eastern Time / 1:30 p.m. Pacific Time

Toll Free:877-407-0784

International:201-689-8560

Conference ID:13703442

Webcast:View Source

A live audio webcast of the presentation will also be available by accessing DURECT’s homepage at www.durect.com and clicking "Investors." If you are unable to participate during the live webcast, the call will be archived on DURECT’s website under "Event Calendar" in the "Investors" section.

On May 11, 2020 SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug resistant infections, reported financial results for the quarter ended on March 31, 2020 and provided an update on recent clinical and corporate developments (Press release, Scynexis, MAY 11, 2020, View Source [SID1234557524]).

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"The past several months have seen major accomplishments by SCYNEXIS, as we continued to generate positive clinical data from both our vaginal yeast infection and hospital-based programs, while also enhancing both our current cash position and our financial flexibility going forward," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "With the successful completion of our Phase 3 VANISH program, we remain on track to submit an NDA for ibrexafungerp as a treatment for vaginal yeast infections in the second half of this year, as we continue SCYNEXIS’s transition to a fully-integrated research and commercial entity. If approved, ibrexafungerp could represent the first new class of antifungals in over 20 years – a particularly significant achievement at a time when the need for novel anti-infectives has become devastatingly clear."

Ibrexafungerp Update

Completed the Phase 3 VANISH program with announcement of positive top-line results for the VANISH-306 study investigating the safety and efficacy of oral ibrexafungerp as a treatment for women with VVC (vaginal yeast infections). In the VANISH-306 study, ibrexafungerp achieved superiority over placebo with high statistical significance (p≤0.01) for the key endpoints required to support the New Drug Application (NDA) filing for this indication. The VANISH-306 study results were consistent with the prior positive efficacy findings observed in the VANISH-303 and the Phase 2b DOVE studies. Additionally, ibrexafungerp had a favorable tolerability profile throughout its Phase 3 program in VVC.

Enrollment is ongoing in the Phase 3 CANDLE study, investigating the safety and efficacy of oral ibrexafungerp for the prevention of recurrent VVC, for which there is no approved therapies in the U.S.. Pending successful completion of this trial, SCYNEXIS anticipates top-line results and the submission of a supplemental NDA for this indication in the second half of 2021.

Announced positive results from the second interim analysis of the ongoing Phase 3 open-label FURI study, evaluating oral ibrexafungerp as a salvage treatment in patients with difficult-to-treat mucocutaneous and invasive fungal infections. In the 41 patients analyzed to date, oral ibrexafungerp showed clinical benefits in 83% of patients, with 56% of patients achieving a complete or partial response and 27% a stable disease response. Of the 41 treated patients, only six did not respond to ibrexafungerp treatment and one patient was considered indeterminate. The protocol was amended to include a larger group of patients with diverse complex fungal infections and to extend the treatment duration beyond 90 days.

Enrollment is ongoing in the Phase 2 SCYNERGIA study for patients with invasive aspergillosis and activities are also ongoing in the development of a liposomal intravenous formulation for ibrexafungerp.

Data presentations. SCYNEXIS continues to educate the scientific community about ibrexafungerp’s clinical potential against a number of pathogens. In February 2020, SCYNEXIS presented in vitro data of ibrexafungerp that showed synergistic activity against Aspergillus isolates from lung transplant recipients at the Advances Against Aspergillosis and Mucormycosis Conference. SCYNEXIS also presented on the Candida auris landscape at the Superbugs and Superdrugs conference in March. Finally, in May 2020, SCYNEXIS announced the publication of six abstracts highlighting the potential clinical utility of ibrexafungerp in the 30th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) abstract book, now available online.
Corporate Developments Subsequent to March 31, 2020

On April 9, 2020, SCYNEXIS entered into a Senior Convertible Note Purchase Agreement with Puissance Life Science Opportunities Fund VI and issued and sold to Puissance $10 million of 6.0% Senior Convertible Notes due 2026.

On April 10, 2020, SCYNEXIS entered into a Common Stock Purchase Agreement with Aspire Capital Fund, LLC, pursuant to which it may sell to Aspire Capital up to $20.0 million in shares of its common stock over the next 30 months.

In April 2020, SCYNEXIS received a cash receipt of $3.1 million from the sale of a portion of its unused Net Operating Losses (NOLs) and R&D credits.
First Quarter Financial Results

Cash, cash equivalents and short-term investments totaled $34.5 million as of March 31, 2020, compared to $48.4 million in cash, cash equivalents, and short-term investments at December 31, 2019.

Research and development expenses for the quarter ended March 31, 2020 increased to $9.9 million from $9.7 million for the quarter ended March 31, 2019. The increase of $0.2 million, or 2%, was primarily driven by an increase of $2.1 million in clinical development costs, an increase of $1.6 million in chemistry, manufacturing, and controls (CMC) costs, and a net increase in other research and development expenses of $0.5 million, mostly offset by a milestone payment made to Merck during the three months ended March 31, 2019.

Selling, general and administrative expenses for the quarter ended March 31, 2020 increased to $2.6 million from $2.2 million for the quarter ended March 31, 2019. The increase of $0.4 million, or 17%, was primarily driven by a $0.3 million increase in professional fees and commercial related expenses.

Total other income increased to $5.5 million for the quarter ended March 31, 2020, compared to total other expense of $11.0 million for the quarter ended March 31, 2019. The increase in other income is primarily attributable to a $4.8 million non-cash gain recorded on the fair value adjustment of the warrant liabilities during the quarter ended March 31, 2020 in comparison to $6.5 million and $3.4 million non-cash losses recognized during the quarter ended March 31, 2019 on the fair value adjustments of the warrants liabilities and derivative liability, respectively.

Net loss for the quarter ended March 31, 2020 was $7.0 million, or ($0.07) net loss per basic and diluted share, compared to a net loss of $22.9 million, or ($0.46) net loss per basic and diluted share, for the quarter ended March 31, 2019.

COVID-19 Update

COVID-19, a novel strain of coronavirus, was first identified in December 2019, and subsequently declared a global pandemic by the World Health Organization on March 11, 2020. SCYNEXIS has been monitoring the COVID-19 pandemic closely and has not identified any significant adverse impacts of COVID-19 to SCYNEXIS’s operations or estimated timelines for the development efforts of ibrexafungerp, including the expected NDA submission for the treatment of vaginal yeast infection in the second half of 2020. The ultimate impact of the COVID-19 health pandemic is highly uncertain and subject to change and SCYNEXIS will continue to monitor the COVID-19 situation closely.

About Ibrexafungerp

Ibrexafungerp [pronounced eye-BREX-ah-FUN-jerp] is an investigational antifungal agent and the first representative of a novel class of structurally-distinct glucan synthase inhibitors, the ‘fungerps’. This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and IV formulations. Ibrexafungerp is currently in development for the treatment of fungal infections caused primarily by Candida (including C. auris) and Aspergillus species. It has demonstrated broad spectrum antifungal activity, in vitro and in vivo, against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains. The FDA has granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for the formulations of ibrexafungerp for the indications of invasive candidiasis (IC) (including candidemia), invasive aspergillosis (IA) and vulvovaginal candidiasis (VVC) and has granted Orphan Drug Designation for the IC and IA indications. Ibrexafungerp is formerly known as SCY-078.

On May 11, 2020 Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH) reported financial results for the quarter ended March 31, 2020 (Press release, Zimmer Holdings, MAY 11, 2020, View Source [SID1234557544]). The Company reported first quarter net sales of $1.784 billion, a decrease of 9.7% from the prior year period, and a decrease of 8.9% on a constant currency basis – both consistent with the preliminary results disclosed in the Company’s press release on April 6, 2020. Net loss for the first quarter was $509 million, including goodwill impairment. Net earnings on an adjusted basis were $354 million.

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Diluted loss per share was $2.46 for the first quarter. Adjusted diluted earnings per share were $1.70 for the first quarter, a decrease of 9.1% from the prior year period.

"While our full first quarter results have been impacted by the global spread of COVID-19 and the deferral of elective procedures, our operational performance prior to the COVID-19 disruption was trending ahead of our expectations," said Bryan Hanson, President and CEO of Zimmer Biomet. "Over the past two years, we have made significant strides in reshaping and evolving Zimmer Biomet. This progress has better positioned us to address the COVID-19 challenge. We have an innovative and mobilized team, operational scale and increased financial flexibility – all of which we are using to support healthcare professionals and patients. I continue to be so proud of our global team and our collective, unyielding commitment to the ZB mission to better the lives of people around the world."

First quarter performance was negatively impacted by COVID-19, which reached a pandemic level in March and resulted in a significant and sudden global decline in elective procedure volumes.

Please see the attached schedules accompanying this press release for additional details on performance in the quarter, including sales by Zimmer Biomet’s three geographies and five product categories.

Geographic and Product Category Sales

The following sales table provides results by geography and product category for the three-month period ended March 31, 2020, as well as the percentage change compared to the prior year period, on both a reported basis and a constant currency basis.

Cash Flow and Balance Sheet

Operating cash flow for the first quarter was $451 million and free cash flow was $325 million. In the first quarter, the Company paid $50 million in dividends and declared a dividend of $0.24 per share. The Company also recently refinanced $1.5 billion in debt that came due April 1, 2020, renegotiated the terms of its $1.5 billion revolver and secured an additional $1.0 billion credit facility.

Financial Guidance

Zimmer Biomet expects the decline in elective procedure volumes observed in the final weeks of the first quarter to continue to have a significant negative impact in the second quarter of 2020. Given the uncertainty around the scope and duration of COVID-19 and its ongoing impact on the deferral of elective procedures, the Company is currently unable to quantify the expected impact on its results of operations, financial condition and cash flows, which could be material, for 2020 and is therefore not providing full-year financial guidance.

Conference Call

The Company will conduct its first quarter 2020 investor conference call today, May 11, 2020, at 8:30 a.m. Eastern Time. The audio webcast can be accessed via Zimmer Biomet’s Investor Relations website at https://investor.zimmerbiomet.com. It will be archived for replay following the conference call.

On May 11, 2020 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported that the Company has regained the commercialization and distribution rights in Europe for LYMPHOSEEK (technetium Tc99m tilmanocept) injection from Norgine B.V. ("Norgine") (Press release, Navidea Biopharmaceuticals, MAY 11, 2020, View Source [SID1234557481]). Navidea and Norgine have decided, by mutual agreement, to end the existing license agreement ("Agreement") between the two companies.

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The Agreement was originally entered in March 2015, and provided Norgine with the exclusive rights in Europe for LYMPHOSEEK. As a result of today’s transaction, Navidea has regained all the rights, economics, and intellectual property of LYMPHOSEEK in Europe.

Per this new agreement, both companies will cooperate to complete a seamless transfer of regulatory marketing authorizations back to Navidea. Through the transition, Norgine will remain responsible for the continued commercialization and distribution of LYMPHOSEEK in Europe for a period of six months.

Jed Latkin, CEO of Navidea, commented, "We would like to thank Norgine for our legacy partnership and initiating the commercialization and distribution in Europe. I am delighted that LYMPHOSEEK’s European rights and economics are now fully in the hands of Navidea. We are excited about the potential for this asset in Europe and will work to mirror the product’s successful and broad-based commercial adoption in the United States."

Management plans to address the new agreement during the Company’s First Quarter 2020 Earnings Conference Call, scheduled for Thursday, May 14, 2020 at 5:00 p.m. (EDT). Conference call and webcast details can be found below.

Additionally, the Company has finalized the previously announced $4.2 million financing related to the judgement by the Ohio Court of Common Pleas (the "Judgement"). Navidea has agreed to issue Keystone Capital Partners, LLC, an existing shareholder, up to $4.2 million of mandatory redeemable preferred shares. These preferred shares are guaranteed by a portion of the proceeds of the Judgement.

Conference Call Details

Event: Q1 2020 Earnings and Business Update Conference Call

About LYMPHOSEEK

LYMPHOSEEK (technetium Tc 99m tilmanocept) is approved in Europe for imaging and intraoperative detection of sentinel lymph nodes draining a primary tumor in adult patients with breast cancer, melanoma, or localized squamous cell carcinoma of the oral cavity. LYMPHOSEEK is designed to locate the sentinel lymph nodes and map lymph node drainage from these cancers.

On May 11, 2020 Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company, reported financial results for the first quarter ended March 31, 2020 (Press release, Pulse Biosciences, MAY 11, 2020, View Source [SID1234557508]).

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Recent Highlights

Completed Pre-Submission meeting with the U.S. Food and Drug Administration (FDA) to establish the criteria for the studies required for a 510(k) submission for the CellFX System for a general indication in aesthetic dermatology

Obtained ISO-13485:2016 Quality System Management Certification to begin preparations for CE Mark filing and subsequent international commercialization of the CellFX System

Initiated a rights offering seeking to raise gross proceeds of approximately $30 million through the sale of units consisting of common stock and warrants to existing stockholders, excluding proceeds of up to $4.5 million from the exercise of warrants issued in the rights offering

"Amid the difficult current circumstances created by the COVID-19 pandemic, Pulse Biosciences has prioritized mitigating infection risks to ensure the health of our team and community while continuing progress towards our goal of commercializing the CellFX System. We are thankful to all the members of the healthcare system and our thoughts are with those impacted by COVID-19," said Darrin Uecker, President and CEO of Pulse Biosciences. "We are very pleased to have recently completed our Pre-Submission meeting with FDA regarding our upcoming 510(k) submission for our CellFX System for a general indication in aesthetic dermatology. We now have greater clarity and confirmation around the requirements to achieve clearance for this indication. We remain extremely confident in the long-term value of our Nano-Pulse Stimulation technology and the value it can provide to patients and physicians in treating a broad range of dermatologic conditions and through additional clinical applications in the future."

Financial Update

Cash, cash equivalents and investments totaled $15.9 million as of March 31, 2020, compared to $25.4 million as of December 31, 2019. Cash used in the first quarter totaled $9.5 million.

Operating expenses for the three months ended March 31, 2020 were $12.0 million, compared to $10.4 million for the prior year period. The increase in operating expenses was driven by the expansion of operational infrastructure including marketing and sales functions as well as the expansion of the research and development teams and clinical trial costs.

Net loss for the first quarter ended March 31, 2020 was $11.9 million compared to $10.1 million for the first quarter ended March 31, 2019.

Impact of COVID-19

Our operations in the first quarter of 2020 experienced minimal impacts as a result of the COVID-19 pandemic. Product development and regulatory timelines have not been materially affected at this point but due to the uncertain scope and duration of the pandemic, we cannot reasonably estimate the future impact to our operations and financial results.

Webcast and Conference Call Information

Pulse Biosciences’ management will host a conference call today, May 11, 2020 beginning at 1:30pm PT. Investors interested in listening to the conference call may do so by dialing 877-705-6003 for domestic callers or 201-493-6725 for international callers. A live and recorded webcast of the event will be available at View Source