On May 7, 2020 Ardelyx, Inc. (Nasdaq: ARDX), a specialized biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with kidney and cardiovascular diseases, reported business highlights and financial results for the first quarter ended March 31, 2020 (Press release, Ardelyx, MAY 7, 2020, View Source [SID1234557395]).

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"During these unprecedented times, our priorities are focused on the well-being and safety of our employees, patients, and communities, while continuing on our mission to provide patients with first-in-class, disruptive medicines based on our breakthrough science," said Mike Raab, president and chief executive officer of Ardelyx. "We are fortunate that much of our clinical work has been completed, with minimal impact of the pandemic on our business, and we are on track to submit our NDA for tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis by mid-year. In preparation for potential approval in mid-2021, we are laying the foundation for launch with important pre-commercial activities underway."

Recent Business and Pipeline Updates

Initial data from NORMALIZE released in December 2019 demonstrated that of the 73 patients, treated for more than one month, 42% achieved normal phosphorus levels of less than 4.6 mg/dL and of those, 58% accomplished this with either tenapanor alone or with tenapanor in combination with only one to three sevelamer tablets per day. These early and exciting data represent a 45% improvement over current phosphate binder data from the 2019 Dialysis Outcomes and Practice Patterns Study (DOPPS), an ongoing, national prospective study of hemodialysis practice.
Appointed industry veteran, Onaiza Cadoret-Manier to the company’s board of directors.
Our collaboration partner in Canada, Knight Therapeutics, received approval from Health Canada for IBSRELA for the treatment of IBS-C in adults.
Planned initiation of the OPTIMIZE clinical trial in 2020, a study to inform physicians on the integration of tenapanor into clinical practice.
Expected 2020 Milestones

Preparing NDA Submission for Tenapanor for the Control of Serum Phosphorus in mid-2020: With strong data from its clinical program for tenapanor, Ardelyx is preparing a New Drug Application for tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis, which the company currently intends to submit to the U.S. Food and Drug Administration in mid-2020.
Reporting AMPLIFY and PHREEDOM Phase 3 results and NORMALIZE Phase 4 results at upcoming medical conferences.
First Quarter 2020 Financial Results

Cash Position: As of March 31, 2020, Ardelyx had total cash, cash equivalents and short-term investments of $223.2 million, as compared to total cash, cash equivalents and short-term investments of $247.5 million as of December 31, 2019.
Revenue: The company generated $1.2 million in revenue, which primarily represents collaborative development revenue, for the quarter ended March 31, 2020.
R&D Expenses: Research and development expenses were $15.8 million for the three months ended March 31, 2020, a decrease of $4.6 million, or 22.3 percent, compared to $20.4 million for the three months ended March 31, 2019. The decrease was due primarily to a decrease in external R&D expenses, with a $5.1 million decrease in tenapanor-related expenses, as well as a $0.8 million decrease in RDX013 program-related expenses, partially offset by $0.8 million of higher expenses attributable to research conducted under the Research Collaboration and Option Agreement entered into with Kyowa Kirin Co., Ltd., in November 2019 and general R&D expenses. Of the overall tenapanor-related decrease, approximately $4.1 million relates to lower clinical study costs and approximately $1.4 million relates to lower manufacturing expenses.
G&A Expenses: General and administrative expenses were $7.1 million for the three months ended March 31, 2020, an increase of $2.0 million, or 39.5 percent, compared to $5.1 million for the three months ended March 31, 2019. The increase in general and administrative expenses was primarily due to an increase in headcount and related personnel costs, including stock-based compensation costs related to option vesting and performance-based restricted stock units, severance expenses related to the departure of the company’s former chief financial officer in March 2020, and an increase in professional services.
Net Loss: Net loss for the quarter ended March 31, 2020 was $22.4 million, as compared to $26.1 million for the quarter ended March 31, 2019.

On May 7, 2020 Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, reported financial results for the first quarter ended March 31, 2020 (Press release, Penumbra, MAY 7, 2020, View Source [SID1234557394]).

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Revenue of $137.3 million in the first quarter of 2020, an increase of 6.9%, or 7.6% in constant currency1, over the first quarter of 2019. Excluding Japan, total revenue in the first quarter of 2020 increased 13.6%, or 14.3% in constant currency1, over the first quarter of 2019.
First Quarter 2020 Financial Results

Total revenue grew to $137.3 million for the first quarter of 2020 compared to $128.4 million for the first quarter of 2019, an increase of 6.9%, or 7.6% on a constant currency basis. The United States represented 70% of total revenue and international represented 30% of total revenue for the first quarter of 2020. Revenue from sales of vascular products grew to $59.3 million for the first quarter of 2020, an increase of 26.2%, or 26.5% on a constant currency basis. Revenue from sales of neuro products declined to $78.1 million for the first quarter of 2020, a decrease of 4.2%, or 3.3% on a constant currency basis.

Gross profit was $88.0 million, or 64.1% of total revenue, for the first quarter of 2020, compared to $83.9 million, or 65.3% of total revenue, for the first quarter of 2019.

Total operating expenses for the first quarter of 2020 were $87.4 million, or 63.6% of total revenue. This compares to total operating expenses of $72.8 million, or 56.6% of total revenue, for the first quarter of 2019. R&D expenses were $12.9 million for the first quarter of 2020, compared to $11.7 million for the first quarter of 2019. SG&A expenses were $74.5 million for the first quarter of 2020, compared to $61.1 million for the first quarter of 2019.

Operating income for the first quarter of 2020 was $0.6 million, compared to an operating income of $11.2 million for the first quarter of 2019.

As of March 31, 2020, cash, cash equivalents and marketable investments totaled $168.2 million. In addition, on April 24, 2020, the Company entered into a secured credit agreement with JPMorgan Chase Bank, N.A., Bank of America, N.A. and Citibank, N.A., that provides for up to $100 million in available revolving borrowing capacity.

Impact of COVID-19 Pandemic

As noted in the Company’s April 6, 2020 press release, the Company began to observe more notable negative impact on business trends in March due to COVID-19. The Company has experienced and believes that the impact of the COVID-19 pandemic on the Company’s business differs by geography and procedure type. Due to the uncertain scope and duration of the pandemic, and uncertain timing of global recovery and economic normalization, we cannot, at this time, reliably estimate the future impact on our operations and financial results.

Webcast and Conference Call Information

Penumbra, Inc. will host a conference call to discuss the first quarter 2020 financial results after market close on Thursday, May 7, 2020 at 5:00 PM Eastern Time. The conference call can be accessed live over the phone by dialing (833) 227-5837 for domestic callers or (647) 689-4064 for international callers (conference id: 3899277), or the webcast can be accessed on the "Events" section under the "Investors" tab of the Company’s website at: www.penumbrainc.com. The webcast will be available on the Company’s website for at least two weeks following the completion of the call.

On May 7, 2020 Eiger BioPharmaceuticals, Inc. (NASDAQ: EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, reported financial results for first quarter 2020 and provided a business update (Press release, Eiger Biopharmaceuticals, MAY 7, 2020, View Source [SID1234557393]).

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"We achieved key milestones this quarter across programs, including Eiger’s first NDA and MAA submissions. Lonafarnib would be the first approved treatment for patients with Progeria and Progeroid Laminopathies," said David Cory, President and CEO of Eiger. "As previously announced, due to the impact of COVID-19, we anticipate full enrollment of our global Phase 3 HDV D-LIVR study in 2021, and we continue to enroll and dose patients. Peginterferon lambda in HDV is now Phase 3-ready, after harmonizing a single pivotal study with FDA and EMA. In addition, we look forward to future results from ongoing investigator sponsored studies of peginterferon lambda in COVID-19 patients."

Recent Highlights and Upcoming Milestones

Lonafarnib in Progeria and Progeroid Laminopathies

Marketing Authorization Application (MAA) validated by EMA
Accelerated Assessment for MAA granted by EMA
New Drug Application (NDA) submitted to FDA in March 2020
Lonafarnib in Hepatitis Delta Virus (HDV)

Phase 3 D-LIVR study (N=400) continues to enroll and dose patients
Full enrollment expected in 2021 due to previously announced impact of COVID-19
Prioritizing the safety of D-LIVR patients, study continuity, and study integrity
Peginterferon Lambda in HDV

Single pivotal Phase 3 study harmonized with FDA and EMA
Phase 2 LIFT (combo with lonafarnib) end-of-treatment data planned for EASL 2020
Peginterferon Lambda in COVID-19

First patients dosed at Stanford University
Six International Investigator Sponsored Studies initiating and enrolling
First Quarter 2020 Financial Results

Cash, cash equivalents, and short-term investments as of March 31, 2020 totaled $77.6 million compared to $95.0 million at December 31, 2019, a decrease of $17 million.

The Company reported net loss of $15.2 million, or $0.62 per share, for first quarter 2020, as compared to $17.2 million, or $0.90 per share, for first quarter 2019.

Research and Development expenses were $9.5 million for first quarter 2020, as compared to $12.9 million for first quarter 2019. The decrease was primarily due to lower clinical trial related expenses, including clinical material costs.

General and Administrative expenses were $5.2 million for first quarter 2020, as compared to $4.1 million for first quarter 2019. The increase was primarily due to increases in employee-related costs, including stock-based compensation, from increased headcount.

Total operating expenses include total non-cash expenses of $2.0 million for first quarter 2020, as compared to $1.4 million for the same period in 2019. As of March 31, 2020 the Company had 24.6 million of common shares outstanding.

On May 7, 2020 BIOLASE, Inc. (NASDAQ: BIOL), the global leader in dental lasers, reported its financial results for the first quarter ended March 31, 2020 (Press release, Biolase Technology, MAY 7, 2020, View Source [SID1234557392]).

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"Our go-to-market strategy was demonstrating meaningful progress prior to the COVID-19 pandemic, reflecting the changes we made throughout 2019 to better align our business and operating infrastructure," said Todd Norbe, President and Chief Executive Officer. "However, we had to adjust our operations in response to the closure of most dental offices during the second half of the quarter, and this business disruption had a significant negative impact on our financial results, as we sold a limited number of lasers in March, which is historically our strongest month of the quarter. In an effort to maintain our presence with key constituencies to preserve these revenue opportunities, we quickly pivoted to increasing the number of online educational forums to showcase our industry-leading products, which have been extremely well attended. Based on the enthusiasm and positive feedback received, we are hopeful that these educational events will result in additional sales leads that we can capitalize on once dentists resume their normal business practices.

"Additionally, we recently announced a partnership with an intensive care unit (ICU) equipment manufacturer to supply ICU-grade portable ventilators through BIOLASE’s FDA-registered manufacturing facility. We have experienced a steady rate of activity and to date we have received over $14 million in orders."

2020 First Quarter Financial Results

Net revenue for the first quarter of 2020 was $4.7 million, a decrease of 54%, compared to net revenue of $10.3 million for first quarter of 2019. U.S. laser revenue was $1.0 million for the first quarter of 2020, a 62% decrease compared to U.S. laser revenue of $2.6 million for the first quarter of 2019. U.S. consumables and other revenue for the first quarter of 2020, which consists of revenue from consumable products such as disposable tips, decreased 28% compared to the first quarter of 2019. Outside the U.S., laser revenue declined 68% to $1.1 million for the first quarter of 2020 compared to $3.4 million for the first quarter of 2019 and consumables and other revenue decreased 28% year over year.

Gross margin for the first quarter of 2020 was 28%, compared to 34% for first quarter of 2019. The lower gross margin reflects the impact of the decline in revenues relative to our fixed costs. Total operating expenses were $6.7 million for the first quarter of 2020 compared to $7.9 million for the first quarter of 2019, a decrease of over 15%. Operating loss for the first quarter of 2020, was $5.4 million, compared to an operating loss of $4.4 million in the first quarter of 2019, an increase of 23% year over year. Net loss for the first quarter of 2020 was $6.0 million, or $0.19 per share, compared to a net loss of $4.9 million, or $0.23 per share, for the first quarter of 2019.

Cash, cash equivalents, and restricted cash totaled $1.8 million as of March 31, 2020.

After the end of the first quarter, BIOLASE applied for and received a $3.0 million loan from the Paycheck Protection Program ("PPP"). The PPP was initiated to help small businesses defined as those businesses in the US with under 500 employees. BIOLASE has approximately 150 employees and is well under the 500 employee defined maximum. In addition, BIOLASE believes the PPP was intended to help small businesses like BIOLASE mitigate the impact of significant lost business during the COVID-19 economic shutdown and to help keep as many people employed as possible. Given the existing market environment, BIOLASE did not believe that it could access public equity markets to raise cash to help make up for the significant lost revenue BIOLASE experienced during the first quarter of 2020 and likely to continue into the second quarter of 2020.

Additionally, both BIOLASE’s President and Chief Executive Office and Chief Financial Officer took temporary 40% salary cuts in connection with COVID-19 cost reduction measures.

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 for the first quarter of 2020 was $3.6 million, or $0.11 per share, compared with Adjusted EBITDA of $3.2 million, or $0.15 per share, for the first 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 first quarter ended March 31, 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 800-353-6461. For international participants outside the U.S./Canada, the dial-in number is 334-323-0501. For all callers, refer to the Conference ID 6799229. 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 May 7, 2020 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") reported financial results and a business update for the first quarter ended March 31, 2020 (Press release, VolitionRX, MAY 7, 2020, View Source [SID1234557391]). Volition management will host a conference call tomorrow, May 8 at 8:30 a.m. U.S. Eastern Time to discuss these results. Conference call details may be found below .

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Cameron Reynolds, President and Chief Executive Officer of Volition, upon releasing these results commented, "During the first quarter, we, together with our collaborators, have made very strong progress, particularly in assay and platform development, with our Nu.QTM Capture program and epigenetic toolkit, Nu.QTM Vet in collaboration with Texas A&M University and, at the start of the year with the acquisition of the epigenetics reagents company, Octamer GmbH. Our team has done an amazing job completing all these milestones in these difficult times."

View Source
An interview with Cameron Reynolds, President and Chief Executive Officer.

Mr. Reynolds added, "We have responded quickly to the COVID-19 pandemic and have a number of clinical trials underway to investigate how Nu.QTM might be clinically useful as either a diagnostic or prognostic tool for COVID-19. I am delighted to announce exciting preliminary results from our first study today and look forward to providing more details throughout this quarter. This work yet again shows the diverse potential of our Nu.QTM platform."

Company Highlights

Clinical – COVID-19

A proof of concept study involving 34 polymerase chain reaction (PCR) COVID-19 positive subjects and 50 control subjects revealed that nucleosomes were highly elevated in the PCR positive subjects.
Preliminary study results demonstrated an Area Under the Curve (AUC) for a single Nu.QTM assay of 98.7% for PCR positive COVID versus control subjects with a sensitivity of 100% at 94% specificity.
A second Nu.QTM assay also showed promising results with an AUC of 86.2%.
Volition plans to utilise results of this trial and other ongoing studies to further its aim of developing a clinically useful product to help in the battle against the COVID-19 global pandemic and potentially other diseases.
Clinical- Veterinary

In a proof of concept study conducted by Texas A&M University, a single Nu.QTM Vet assay detected almost 70% of both Canine Hemangiosarcoma and Canine Lymphoma with AUCs of 84.5% and 83.1% cancer versus healthy, respectively, at a specificity of 90%. These two cancers alone represent almost a third of all canine cancers.
Based on the results of this study, Volition plans to move forward with other Nu.QTM Vet assays in its pipeline, and with the larger range of cohorts and trials that it has collected and planned.
Abstract Publications

Three of Volition’s abstracts have been accepted for publication by ASCO (Free ASCO Whitepaper) (American Society of Clinical Oncology) and are expected to be publicly released on Wednesday, May 13.
Assay Development

Volition has completely re-engineered its Nu.QTM assays to now use a magnetic particle-based assay format leading to a step-change improvement in analytical performance which Volition expects to translate into improved clinical performance.
Volition reached its target of eight assays being finalized by the end of the first quarter with respect to its fully-automated magnetic bead-based chemiluminescent format. Studies are now ongoing for colorectal cancer, lung cancer and blood cancer with data read outs expected by the end of the second quarter.
Volition signed a contract with Shanghai Fosun Long March Medical Science Co., Ltd ("Fosun Long March"), China, to further develop our Nu.QTM magnetic particle-based assays for use on Fosun’s open-access platform LUMIART-II Automated Chemiluminescence Immunoassay System. The agreement also allows for the parties to negotiate an exclusive licensing agreement for Fosun Long March to distribute Volition’s Nu.QTM tests for the LUMIART System in China.
Epigenetic Toolbox

Volition has developed and is seeking patents on its novel Nu.QTM Capture-based epigenetic tools. Volition is using these tools to expand diagnostic developments that focus on circulating DNA fragment analysis, leading to a broader and potentially more powerful investigation of the epigenetic status of a patient’s circulating chromosome fragments, in addition to its ongoing work with its assay-based format in a range of cancers. Volition expects additional data on this in the coming months.
Organization

Volition completed the acquisition of its epigenetics reagents subsidiary, Octamer GmbH (renamed Volition Germany GmbH), in the first quarter of 2020.
In connection with the acquisition of Octamer, Volition expanded its Scientific Advisory Board to include Dr. Adrian Schomburg, one of the world’s leading experts on nucleosomes and founder and CEO of Octamer.
Financial

Cash and cash equivalents as of March 31, 2020 totalled approximately $12 million.
Upcoming Milestones

Volition expects to achieve the following milestones during 2020 and beyond:

Release a range of clinical data from COVID-19 studies currently underway.
Release a range of clinical data with its new optimised bead-based assays in colorectal, lung and other cancers.
Advance its previously announced large-scale colorectal and lung cancer trials in Europe, Asia and the U.S.
Advance the development of Nu.QTM Capture by determining the level of discrimination of tumor associated nucleosomes using mass spectrometry and/or sequencing.
Announce patient data demonstrating the wide utility of its epigenetic toolbox.
Complete further clinical studies for Nu.QTM Vet with the aim of launching its first product in 2020.
Publish several abstracts and peer reviewed scientific papers with clinical results as well as showing the robustness and utility of its Nu.QTM platform.
Mr. Reynolds concluded, "We are extremely proud of the accomplishments we have achieved thus far. I thank the dedicated Volition team for their tireless efforts especially given the challenging circumstances we all face during the COVID-19 pandemic. I, along with the rest of the Board and indeed the whole company, look forward to sharing the results of key studies over the coming year."

As a result of the COVID-19 pandemic during the first quarter of 2020, Volition implemented contingency planning to protect the health and well-being of its employees, with most employees working remotely where possible. Its laboratory in Belgium has remained open with the attendance of its dedicated laboratory technicians who have kept its research and development work on track with Volition’s expectations. Many of its small and medium sized studies have already been collected and their samples stored at its onsite biobank so the trial work underway and planned for the first half of 2020 is still tracking expectations. Regarding its large-scale studies, both the colorectal cancer and lung cancer studies underway in Taiwan are still ongoing with collection, however the study collection in the U.S. with the EDRN has been paused during the pandemic. The overall timing impact of the EDRN collection pause on the study is unknown at this stage, however, Volition will provide an update once the study re-commences.

For further details please contact [email protected]

VolitionRx Limited First Quarter 2020 Earnings
and Business Update Conference Call

Date: Friday, May 8, 2020
Time: 8:30 a.m. Eastern time
U.S. & Canada Dial-in: 1-877-407-9716 (toll free)
U.K. Dial-in: 0 800 756 3429 (toll free)
Toll/International: 1-201-493-6779
Conference ID: 13703451

Cameron Reynolds, President and Chief Executive Officer of Volition, will host the call along with David Vanston, Chief Financial Officer and Scott Powell, Executive Vice President, Investor Relations.

A live audio webcast of the conference call will also be available on the investor relations page of Volition’s corporate website at View Source In addition, a telephone replay of the call will be available until May 22, 2020. The replay dial-in numbers are 1-844-512-2921 (toll-free) in the U.S. and Canada and 1-412-317-6671 (toll) internationally. Please use replay pin number 13703451.