UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C.  20549

 


 

FORM 8-K

 


 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): April 23, 2020

 

BioSig Technologies, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware

001-38659

26-4333375

(State or other jurisdiction

(Commission File Number)

(IRS Employer

of incorporation)

  

Identification No.)

 

54 Wilton Road, 2nd Floor

Westport, Connecticut

  

06880

(Address of principal executive offices)

  

(Zip Code)

 

(203) 409-5444

(Registrant’s telephone number, including area code)

 

                                       N/A                                        

(Former name or former address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

☐ Pre-commencement communications pursuant to Rule 13e-4 (c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading Symbol(s)

 

Name of exchange on which registered

Common Stock, par value $0.001 per share

 

BSGM

 

The NASDAQ Capital Market  

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company ☐

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

 

Item 5.08            Shareholder Director Nominations

 

On April 24, 2020, the board of directors (the “Board”) of BioSig Technologies, Inc. (the “Company”) established June 26, 2020, as the date for the Company’s 2020 Annual Meeting of Stockholders (the “Annual Meeting”) and set April 28, 2020, as the record date for the Annual Meeting. Due to the fact that the date of the Annual Meeting has been changed by more than 30 days from the anniversary date of the 2019 Annual Meeting of Stockholders, the Company is providing the due date for submission of any qualified stockholder proposal or qualified stockholder nominations.

 

In accordance with Rule 14a-5(f) and Rule 14a-8(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and the Company’s amended and restated bylaws, the deadline for receipt of stockholder proposals or nominations for inclusion in the Company’s proxy statement for the Annual Meeting pursuant to Rule 14a-8 will be no later than 5:00 p.m., Eastern Time, May 4, 2020. Stockholder proposals must comply with all of the applicable requirements set forth in the rules and regulations of the Securities and Exchange Commission, including Rule 14a-8 under the Exchange Act and the Company’s amended and restated bylaws.

 

Item 8.01            Other Events.

 

On April 23, 2020, the Company issued a press release announcing that the Company’s subsidiary, ViralClear Pharmaceuticals, Inc. (“ViralClear”), published comparative in vitro data on merimepodib and remdesivir activity against COVID-19 in F1000 Research. A copy of this press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.

 

On April 24, 2020, the Company issued a press release announcing that ViralClear submitted an Investigational New Drug Application to the Food and Drug Administration for its Phase II clinical trial with merimepodib as a treatment for COVID-19. A copy of this press release is filed as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated by reference herein.

 

On April 24, 2020, the Company also issued a press release announcing that it will be hosting a conference call on recent developments of ViralClear and its product candidate merimepodib. A copy of this press release is filed as Exhibit 99.3 to this Current Report on Form 8-K and is incorporated by reference herein.

 

Item 9.01             Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit Number

 

Description

99.1

 

Press Release, dated April 23, 2020

99.2

 

Press Release, dated April 24, 2020

99.3

 

Press Release, dated April 24, 2020

 

 

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

 

 

 

 

 

Date: April 24, 2020    

By:

/s/ Kenneth L. Londoner 

 

 

 

Name: Kenneth L. Londoner

 

 

 

Title: Executive Chairman

 

 

 

 

 

 

 

Exhibit 99.1

 

 

ViralClear Publishes Comparative In Vitro Data on Merimepodib and Remdesivir Activity Against the COVID-19 Novel Coronavirus in F1000 Research

 

 

Merimepodib is shown to decrease viral production of COVID-19 coronavirus more than remdesivir at clinically meaningful drug concentrations in pre-clinical testing.

 

 

Article highlights recent work done in laboratory studies of COVID-19 with merimepodib at the Galveston National Laboratory at The University of Texas Medical Branch

 

Westport, CT, April 23, 2020 (GLOBE NEWSWIRE) -- BioSig Technologies, Inc. (Nasdaq: BSGM) today announced that an article titled, The IMPDH inhibitor merimepodib has similar antiviral activity against SARS-CoV-2 replication in vitro to the adenosine analogue remdesivir” was accepted by F1000 Research, an  online peer-reviewed life sciences journal publishing program in biology and medicine.

 

This manuscript is authored by Natalya Bukreyeva, Rachel A. Sattler, Emily K. Mantlo, John T. Manning, Cheng Huang and Slobodan Paessler of the UTMB Galveston National Laboratory and Dr. Jerome Zeldis of ViralClear Pharmaceuticals, Inc. (“ViralClear”) as a corresponding author.

 

The article highlights emerging pre-clinical data generated under contract with Galveston National Laboratory at The University of Texas Medical Branch. The work was started with Trek Therapeutics and after merimepodib was acquired by ViralClear has been continued by ViralClear.

 

“The concentrations of merimepodib used in the cell culture studies described in this article are achievable in humans by our oral solution formulation,” said Dr. Zeldis, Executive Chair and Founder of ViralClear Pharmaceuticals, Inc. “We are now exploring whether remdesivir and merimepodib are synergistic in this in vitro model. We look forward to starting our first clinical trial in COVID-19 patients upon receiving FDA clearance to commence with the proposed phase 2 trial.”

 

Vero cells in tissue culture were pre-treated with two concentrations (2.5 and 5 µM) of either merimepodib or remdesivir for 4 hours before the SARS-CoV-2 coronavirus was added. The amount of virus released to the media was measured at baseline and 16 hours and 24 hours after infection. At 16 hours, a significant reduction in viral production was observed for both concentrations of merimepodib (1.9 log decrease in titer, p = 0.003 and 2.1 log decrease in titer, p = 0.001) but only at the higher concentration of remdesivir (1 log decrease in titer, p = 0.103 and 2.1-log decrease in titer, p = 0.001). At 24 hours both concentrations of both drugs significantly reduced viral production; however, 2.5 µM remdesivir reduced viral titer by 1.5 logs (p = 0.002) as compared to a decrease of 3.9 logs for 5 µM remdesivir (p < 0.001), whereas 2.5 and 2.7 log reductions (p = 0.001 and p < 0.001, respectively) were observed for the 2.5 and 5 µM concentrations of merimepodib.

 

 

 

 

Merimepodib, a broad-spectrum anti-viral candidate, demonstrated strong activity against COVID-19 in cell cultures in laboratory testing and additional antiviral studies are underway. Merimepodib was previously in development as a treatment for chronic hepatitis C and psoriasis by Vertex Pharmaceuticals Incorporated (Vertex), with a 12 clinical trials conducted (including 315 chronic hepatitis C patients, 24 psoriasis patients, and 98 healthy volunteers) and an extensive preclinical safety package completed . ViralClear intends to pursue development of this agent for the treatment of COVID-19 through FDA-approved clinical trials in Q2 2020.

 

About BioSig Technologies
BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com).

 

The Company’s first product, PURE EP(tm) System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.

 

About ViralClear

BioSig’s subsidiary ViralClear Pharmaceuticals, Inc., is seeking to develop a novel pharmaceutical to treat advanced COVID-19. Merimepodib is a broad-spectrum anti-viral agent that has demonstrated strong activity against the COVID-19 virus in cell cultures in laboratory testing. ViralClear plans to initiate a multi-center, phase 2, randomized, double-blind, placebo-controlled study of the efficacy and safety of merimepodib administered orally every eight hours for 10 days in adult patients with advanced COVID-19 upon FDA clearance to proceed. Merimepodib has been studied in twelve clinical trials prior to this study, including five trials in patients with hepatitis C (one phase 1b, one phase 2, two phase 2a, and one phase 2b), one trial in patients with psoriasis (phase 2), and six trials in healthy volunteers (all phase 1). 

 

Forward-looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

 

Contact:                    

                                   
Andrew Ballou                         
BioSig Technologies, Inc.                     
Vice President, Investor Relations                

54 Wilton Road, 2nd floor                    

Westport, CT 06880                         

aballou@biosigtech.com                    

203-409-5444, x133          

 

 

 

 

Exhibit 99.2

 

 

 

BioSig Subsidiary ViralClear Submits Investigational New Drug Application to the FDA for Phase II Clinical Trials for Merimepodib, an Orally Administered Treatment for Patients with COVID-19   

 

 

In vitro studies demonstrated decrease of viral production by over 98%

 

 

Upon approval, clinical trial to be conducted at Mayo Clinic under the leadership of Andrew D. Badley, M.D., Professor and Chair of Department of Molecular Medicine and the Enterprise Chair of COVID-19 Task Force

 

Westport, CT, April 24, 2020 /GLOBE NEWSWIRE/ — BioSig Technologies, Inc. (Nasdaq: BSGM) (“BioSig” or the “Company”) today announced that its subsidiary ViralClear Pharmaceuticals, Inc. submitted an Investigational New Drug (IND) Application to the Food and Drug Administration (FDA) for its Phase II clinical trial with Merimepodib as a treatment for COVID-19.

 

The study will be a randomized, placebo-controlled trial to evaluate the efficacy and safety of Merimepodib in patients with COVID-19. The placebo-controlled Phase II clinical trial calls for 20 planned patients from three Mayo Clinic sites: Rochester, MN; Scottsdale, AZ; and Jacksonville, FL. Data from the Phase II trial is expected within three months of the commencement of the trial. Upon approval from the FDA to commence, the Phase II clinical trial will be conducted at Mayo Clinic under the leadership of Andrew D. Badley, M.D., Professor and Chair of Department of Molecular Medicine and the Enterprise Chair of COVID-19 Task Force.

 

“We are very pleased that the Mayo Clinic IRB Committee has approved our protocol,” commented Jerome Zeldis, M.D., Ph.D., Executive Chairman of ViralClear Pharmaceuticals, Inc. “We are now waiting for the submitted IND to be filed before we can commence the trial”.

 

“Our internal team and our colleagues at Mayo Clinic have moved with focus and speed over the past few weeks. We have been gratified by the professionalism and commitment that has been brought to this critical work,“ commented Nick Spring, CEO of ViralClear Pharmaceuticals, Inc.

 

About BioSig Technologies
BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com).

 

The Company’s first product, PURE EP(tm) System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.

 

 

 

 

About ViralClear

BioSig’s subsidiary ViralClear Pharmaceuticals, Inc., is seeking to develop a novel pharmaceutical to treat advanced COVID-19. Merimepodib is a broad-spectrum anti-viral agent that has demonstrated strong activity against the COVID-19 virus in cell cultures in laboratory testing. ViralClear plans to initiate a multi-center, phase 2, randomized, double-blind, placebo-controlled study of the efficacy and safety of merimepodib administered orally every eight hours for 10 days in adult patients with advanced COVID-19 upon FDA clearance to proceed. Merimepodib has been studied in twelve clinical trials prior to this study, including five trials in patients with hepatitis C (one phase 1b, one phase 2, two phase 2a, and one phase 2b), one trial in patients with psoriasis (phase 2), and six trials in healthy volunteers (all phase 1). 

 

Forward-looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

 

Contact:                    

                                   
Andrew Ballou                         
BioSig Technologies, Inc.                     
Vice President, Investor Relations                

54 Wilton Road, 2nd floor                    

Westport, CT 06880                         

aballou@biosigtech.com                    

203-409-5444, x133          

 

 

 

 

Exhibit 99.3

 

 

BioSig to Host Conference Call on Recent Developments of Subsidiary ViralClear and its Broad-Spectrum Oral Anti-Viral Candidate Merimepodib for the Treatment of COVID-19

 

Company’s subsidiary ViralClear recently submitted an Investigational New Drug application to the FDA for its Phase II clinical trial with Merimepodib as a treatment for COVID-19

 

Westport, CT, April 24, 2020 /GLOBE NEWSWIRE/ — BioSig Technologies, Inc. (Nasdaq: BSGM) (“BioSig” or the “Company”) today announced that it will be hosting an investor briefing to provide an update on the progress of its subsidiary ViralClear Pharmaceuticals, Inc, and recent developments of merimepodib (MMPD).

 

The Company recently submitted an Investigational New Drug (IND) Application to the Food and Drug Administration (FDA) to commence a Phase II clinical trial with merimepodib as a treatment for COVID-19. The conference call is being held on Wednesday, April 29, 2020 at 11:00 AM ET.

 

Kenneth L. Londoner, MBA, Chairman and CEO of BioSig Technologies, Inc. will be joined by Nick Spring, CEO of ViralClear Pharmaceuticals, Inc., Steven King, COO of ViralClear Pharmaceuticals, Inc., and Jerome Zeldis, M.D., Ph.D., Executive Chairman of ViralClear Pharmaceuticals, Inc.

 

Conference Call Details:
Date: Wednesday, April 29, 2020
Time: 11:00 AM Eastern Time (ET)
Dial in Number for U.S. Callers: 1-877-407-4177
Dial in Number for International Callers: 1-201-689-8325

Participant Entry Passcode: 13702950 (followed by #)

 

A replay will be available for two weeks starting on April 29, 2020 at approximately 2:00 PM ET. To access the replay, please dial 1-877-660-6853 in the U.S. and 1-201-612-7415 for international callers. The conference ID# is 13702950.

 

On April 24, 2020 the Company announced that ViralClear submitted an Investigational New Drug (IND) Application to the Food and Drug Administration (FDA) to commence a Phase II clinical trial with merimepodib as a treatment for COVID-19. On April 23, 2019, ViralClear published comparative in vitro data on merimepodib and remdesivir activity against the COVID-19 novel coronavirus in F1000 Research. Merimepodib was shown to decrease viral production of COVID-19 coronavirus more than remdesivir at clinically meaningful drug concentrations in pre-clinical testing.

 

 

 

 

Upon approval from the FDA to commence, the Phase II clinical trial will be conducted at Mayo Clinic under the leadership of Andrew D. Badley, M.D., Professor and Chair of Department of Molecular Medicine and the Enterprise Chair of COVID-19 Task Force. The study will be a randomized, placebo-controlled trial to evaluate the efficacy and safety of Merimepodib in patients with COVID-19. The placebo-controlled Phase II clinical trial calls for 20 planned patients from three Mayo Clinic sites: Rochester, MN; Scottsdale, AZ; and Jacksonville, FL. Data from the Phase II trial is expected within three months of the commencement of the trial.

 

About BioSig Technologies
BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com).

 

The Company’s first product, PURE EP(tm) System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.

 

About ViralClear

BioSig’s subsidiary ViralClear Pharmaceuticals, Inc., is seeking to develop a novel pharmaceutical to treat advanced COVID-19. Merimepodib is a broad-spectrum anti-viral agent that has demonstrated strong activity against the COVID-19 virus in cell cultures in laboratory testing. ViralClear plans to initiate a multi-center, phase 2, randomized, double-blind, placebo-controlled study of the efficacy and safety of merimepodib administered orally every eight hours for 10 days in adult patients with advanced COVID-19 upon FDA clearance to proceed. Merimepodib has been studied in twelve clinical trials prior to this study, including five trials in patients with hepatitis C (one phase 1b, one phase 2, two phase 2a, and one phase 2b), one trial in patients with psoriasis (phase 2), and six trials in healthy volunteers (all phase 1). 

 

Forward-looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

 

Shareholder contact:                    

                                   
Andrew Ballou                         
BioSig Technologies, Inc.                     
Vice President, Investor Relations                

54 Wilton Road, 2nd floor                    

Westport, CT 06880                         

aballou@biosigtech.com                    

203-409-5444, x133