CNS Pharmaceuticals Announces Filing of FDA Orphan Drug Designation for Brain Cancer Drug Berubicin

On April 23, 2020 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biotechnology company specializing in the development of novel treatments for brain tumors, reported it has filed an application with the U.S. Food and Drug Administration (FDA) to receive Orphan Drug Designation (ODD) for its lead product Berubicin (Press release, CNS Pharmaceuticals, APR 23, 2020, View Source [SID1234556563]).

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Under a prior developer, Berubicin, then known as RTA 744, was granted ODD by the FDA for the treatment of malignant gliomas. In the prior developer’s Phase 1 trial of Berubicin, 44% of the patients demonstrated a significant improvement in progression free survival. Additionally, one patient in this study experienced a complete response to his treatment with Berubicin.

"We are excited to announce the Orphan Drug application submission for Berubicin, as it would grant special status and accelerate the development of Berubicin to treat glioblastoma, one of the world’s most aggressive forms of cancer," stated John Climaco, CEO of CNS Pharmaceuticals. "We are pleased to continue to execute upon our strategic initiatives and submit our application within the anticipated timeline outlined within our previous filings. We feel cautiously optimistic about the application, given the past Orphan Drug Designation of the molecule and positive Phase 1 results. We look forward to initiating a Phase II trial evaluating the effect of Berubicin on patients with glioblastoma later this year."

The Orphan Drug Act ("ODA") provides for granting special status to a drug or biological product to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation (or sometimes "orphan status").

The FDA grants Orphan Drug Designation status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States at any given time. Due to small patient numbers, treatment for these rare diseases would not be considered economically feasible without government programs to support their economic viability. Orphan Drug Designation would qualify Berubicin for certain benefits and incentives, including seven years of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain activities, eligibility for orphan drug grants, and the waiver of certain administrative fees. The receipt of Orphan Drug Designation status does not change the regulatory requirements or process for obtaining marketing approval.

About Berubicin
Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata.

Triple-S Management Corporation Schedules First Quarter 2020 Earnings Release and Conference Call

On April 23, 2020 Triple-S Management Corporation (NYSE: GTS) reported that it plans to release financial results for the first quarter ended March 31, 2020 before the market opens on Thursday, May 7, 2020 (Press release, Triple-S Management, APR 23, 2020, https://www.prnewswire.com/news-releases/triple-s-management-corporation-schedules-first-quarter-2020-earnings-release-and-conference-call-301045666.html [SID1234556562]). Roberto García-Rodríguez, President and Chief Executive Officer, and Juan José Román-Jiménez, EVP and Chief Financial Officer, will host a conference call to discuss these results at 8:30 a.m. Eastern Time.

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To participate on the call, please dial 1-888-204-4368 or 1-323-994-2093 at least 5 minutes before start time. The conference call will also be simulcast live on the Internet, and can be accessed by logging onto www.triplesmanagement.com.

In addition, a replay will be available through May 21, 2020 by calling 1-844-512-2921 or 1-412-317-6671 and entering replay pin number 9070409. A replay will also be available at www.triplesmanagement.com for 30 days.

First Patient in Treatment in RhoVac’s Clinical Phase IIb Study in Germany

On April 23, 2020 RhoVac AB ("RhoVac") reported, on 23rd April 2020, that the first patient in Germany is in treatment in the company’s clinical phase IIb study in prostate cancer, a study entitled RhoVac-002 ("BRaVac") (Press release, RhoVac, APR 23, 2020, View Source [SID1234556561]).

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The first patient in Germany is in treatment in the clinical study, called BRaVac. This clinical trial phase IIb-study is a randomized, placebo-controlled and double-blind study, with the primary objective of evaluating if treatment with the drug candidate RV001 can prevent or limit the development of advanced prostate cancer after curative treatment. The clinical phase IIb study is an international, multicenter study, which will recruit over 175 patients in six European countries (Denmark, Finland, Sweden, Belgium, Germany and Great Britain) and the US. RhoVac has, as previously announced, started clinical phase IIb trials in Denmark and Finland.

Anders Månsson, CEO, comments: "We are pleased that the recruitment of patients in our clinical phase IIb trial is progressing and that more and more countries are joining the study, despite the impact of the pandemic."

For further information, please contact:

Anders Månsson – CEO, RhoVac AB
Phone number: +46-73-751 72 78
E-mail: [email protected]

This information is such that RhoVac AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on 23rd April 2020.

Penumbra, Inc. Schedules First Quarter 2020 Earnings Release and Conference Call for May 7, 2020

On April 23, 2020 Penumbra, Inc. (NYSE: PEN) reported that it will host a conference call to discuss financial results for the first quarter 2020 after market close on Thursday, May 7, 2020 at 5:00 PM Eastern Time (Press release, Penumbra, APR 23, 2020, View Source [SID1234556560]). A press release with first quarter 2020 financial results will be issued after market close that day.

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Webcast & Conference Call Information
The conference call can be accessed live over the phone by dialing (866) 393-4306 for domestic callers or (734) 385-2616 for international callers (conference id: 9896847), 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.

eHealth, Inc. Announces First Quarter 2020 Results

On April 23, 2020 eHealth, Inc. (NASDAQ: EHTH), a leading private online health insurance marketplace, reported its financial results for the first quarter ended March 31, 2020 (Press release, eHealth Insurance, APR 23, 2020, View Source [SID1234556559]).

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Scott Flanders, chief executive officer of eHealth stated, "In this challenging environment shaped by the COVID-19 pandemic, our company mission to connect every person with the highest quality, most affordable health insurance for their life circumstances is more relevant and important than ever. As social distancing measures remain in place around the country, we are glad to be able to continue to meet consumers wherever it is easiest, most convenient, and safest for them to engage – online and by speaking to a licensed insurance agent over the phone."

Mr. Flanders continued, "Building on our strong momentum of the past two years, and our record performance in 2019, we are pleased to deliver another quarter of outperformance. The fundamentals of our business are strong and we are achieving strong operating metrics across the business by executing on a clear strategy and making targeted investments to drive growth. Our updated 2020 annual guidance reflects our outperformance to-date, but does not include the additional investments we are contemplating and planning for this year’s Annual Enrollment Period. These will be provided in conjunction with our second quarter results."

GAAP — First Quarter of 2020 Results

Revenue — Revenue for the first quarter of 2020 totaled $106.4 million, a 55% increase compared to $68.8 million for the first quarter of 2019. Commission revenue for the first quarter of 2020 totaled $99.7 million, a 55% increase compared to $64.2 million for the first quarter of 2019. Other revenue for the first quarter of 2020 was $6.7 million, a 48% increase compared to $4.5 million for the first quarter of 2019.

Revenue from our Medicare segment was $96.2 million for the first quarter of 2020, a 75% increase compared to $54.9 million for the first quarter of 2019. Revenue from our Individual, Family and Small Business segment was $10.3 million for the first quarter of 2020, a 26% decrease compared to $13.9 million for the first quarter of 2019.

Income (Loss) from Operations — Income from operations for the first quarter of 2020 was $1.0 million compared to loss from operations of $9.2 million for the first quarter of 2019.

Pre-Tax Income (Loss) — Pre-tax income for the first quarter of 2020 was $1.4 million compared to pre-tax loss of $8.6 million for the first quarter of 2019.

Benefit from Income Taxes — Benefit from income taxes for the first quarter of 2020 was $2.0 million compared to $3.5 million for the first quarter of 2019.

Net Income (Loss) — Net income for the first quarter of 2020 was $3.5 million, or $0.13 net income per diluted share, compared to net loss of $5.2 million, or $0.24 net loss per diluted share, for the first quarter of 2019.

Segment Profit — Medicare segment profit was $22.0 million for the first quarter of 2020, a 103% increase compared to $10.8 million for the first quarter of 2019. Profit from our Individual, Family and Small Business segment was $2.6 million for the first quarter of 2020, a 57% decrease, compared to $6.0 million for the first quarter of 2019.

Non-GAAP — First Quarter of 2020 Results

Non-GAAP Net Income — Non-GAAP net income for the first quarter of 2020 was $10.3 million, or $0.39 non-GAAP net income per diluted share, compared to non-GAAP net income of $7.2 million, or $0.33 non-GAAP net income per diluted share, for the first quarter of 2019.

Non-GAAP net income and non-GAAP net income per diluted share for the first quarter of 2020 are calculated by excluding $8.7 million of stock-based compensation expense, $0.5 million of amortization of intangible assets and $2.4 million of the income tax effect of these non-GAAP adjustments from GAAP net income and GAAP net income per diluted share.

Non-GAAP net income and non-GAAP net income per diluted share for the first quarter of 2019 are calculated by excluding $3.2 million of stock-based compensation expense, $13.3 million of expense for the change in fair value of earnout liability related to our acquisition of GoMedigap, $0.5 million of amortization of intangible assets, and $4.7 million of the income tax effect of these non-GAAP adjustments from GAAP net loss and GAAP net loss per diluted share.

Adjusted EBITDA — Adjusted EBITDA was $11.1 million for the first quarter of 2020 compared to $8.6 million for the first quarter of 2019. Adjusted EBITDA is calculated by adding stock-based compensation, change in fair value of earnout liability related to our acquisition of GoMedigap, depreciation and amortization expense, amortization of intangible assets, other income, net, and benefit from income taxes to GAAP net income (loss).

Approved Members, New Paying Members and Estimated Membership

Approved Members — The number of approved members for all Medicare products, which includes Medicare Advantage, Medicare Supplement and Medicare Part D Prescription Drug Plans, was 84,702 in the first quarter of 2020, a 46% increase compared to 57,899 in the first quarter of 2019. The number of approved members for major medical individual and family plan products declined by 19% in the first quarter of 2020 to 9,365 compared to 11,598 in the first quarter of 2019.

New Paying Members — The number of new paying members for all Medicare products was 161,564 in the first quarter of 2020, a 61% increase compared to 100,113 in the first quarter of 2019. The number of new paying members for major medical individual and family plan products was 15,510, a 28% decrease compared to 21,402 in the first quarter of 2019. New Paying Members consist of approved members from the period presented and any periods prior to the period presented from whom we have received an initial commission payment during the period presented.

Estimated Membership — Total estimated membership as of March 31, 2020 was 1,136,954, a 19% increase compared to 952,239 estimated members we reported as of March 31, 2019. Estimated Medicare membership as of March 31, 2020 was 725,943, a 44% increase compared to 503,877 estimated members reported as of March 31, 2019. Estimated major medical individual and family plan membership as of March 31, 2020 was 113,483, a 13% decrease compared to 130,297 estimated members reported as of March 31, 2019.

Cash — First Quarter of 2020

Cash Flows — Net cash provided by operating activities was $8.9 million for the first quarter of 2019, compared to net cash provided by operating activities of $12.7 million for the first quarter of 2019.

2020 Guidance

Based on information available as of April 23, 2020, eHealth is updating its guidance for the full year ending December 31, 2020 previously provided on February 20, 2020. These expectations are forward-looking statements and eHealth assumes no obligation to update these statements. Actual results may be materially different and are affected by the risk factors and uncertainties identified in this press release and in eHealth’s annual and quarterly filings with the Securities and Exchange Commission.

The following is the updated guidance for the full year ending December 31, 2020:

Total revenue is expected to be in the range of $600.0 million to $640.0 million, compared to the previous guidance of $580.0 million to $620.0 million. Revenue from the Medicare segment is expected to be in the range of $553.0 million to $589.0 million, compared to the previous guidance of $533.0 million to $569.0 million. Revenue from the Individual, Family and Small Business segment is expected to be in the range of $47.0 million to $51.0 million, consistent with the previous guidance.
GAAP net income is expected to be in the range of $70.0 million to $85.0 million, compared to the previous guidance of $68.0 million to $83.0 million.
Adjusted EBITDA(a) is expected to be in the range of $125.0 million to $140.0 million, compared to the previous guidance of $120.0 million to $135.0 million.
Medicare segment profit(b) is expected to be in the range of $157.0 million to $174.0 million, compared to the previous guidance of $152.0 million to $169.0 million. Individual, Family and Small Business segment profit is expected to be in the range of $17.0 million to $18.0 million, consistent with the previous guidance.
Corporate(c) shared service expenses, excluding stock-based compensation and depreciation and amortization expense, is expected to be in range of $49.0 million to $52.0 million, consistent with the previous guidance.
Cash used in operations is expected to be in the range of $61.0 million to $64.0 million, compared to the previous guidance of $52.0 million to $55.0 million, and cash used for capital expenditures is expected to be $18.0 million to $20.0 million, consistent with the previous guidance.
GAAP net income per diluted share is expected to be in the range of $2.55 to $3.10, compared to the previous guidance of $2.64 to $3.23 per share.
Non-GAAP net income per diluted share(d) is expected to be in the range of $3.41 to $3.90, compared to the previous guidance of $3.56 to $4.09 per share.

Adjusted EBITDA is calculated by adding stock-based compensation, change in fair value of earnout liability, depreciation and amortization expense, amortization of intangible assets, other income, net, and provision (benefit) for income taxes to GAAP net income (loss).

Segment profit is calculated as revenue for the applicable segment less Marketing and Advertising, Customer Care and Enrollment, Technology and Content and General and Administrative operating expenses, excluding stock-based compensation, change in fair value of earnout liability, depreciation and amortization expense and amortization of intangible assets, that are directly attributable to the applicable segment and other indirect Marketing and Advertising, Customer Care and Enrollment and Technology and Content operating expenses, excluding stock-based compensation, depreciation and amortization expense and amortization of intangible assets, allocated to the applicable segment based on usage.

Corporate consists of other indirect General and Administrative operating expenses, excluding stock-based compensation and depreciation and amortization expense, which are managed in a corporate shared services environment and, since they are not the responsibility of segment operating management, are not allocated to the reportable segments.

Non-GAAP net income per diluted share is calculated by adding stock-based compensation expense per diluted share, change in fair value of earnout liability per diluted share, intangible asset amortization expense per diluted share and the income tax effect of these non-GAAP adjustments to GAAP net income per diluted share.

Webcast and Conference Call Information

A Webcast and conference call will be held today, Thursday, April 23, 2020 at 5:00 p.m. Eastern / 2:00 p.m. Pacific Time. The live Webcast and supporting presentation slides will be available on the Investor Relations section of eHealth’s website at View Source Individuals interested in listening to the conference call may do so by dialing (877) 930-8066 for domestic callers and (253) 336-8042 for international callers. The participant passcode is 8091632. A telephone replay will be available two hours following the conclusion of the call for a period of seven days and can be accessed by dialing (855) 859-2056 for domestic callers and (404) 537-3406 for international callers. The call ID for the replay is 8091632. The live and archived webcast of the call will also be available on eHealth’s website at View Source under the Investor Relations section.