8-K
Streamex Corp. (STEX)
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): July 30, 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<br><br> <br>Westport, Connecticut | 06880 | |
| --- | --- | |
| (Address of principal executive offices) | (Zip Code) |
(203) 409-5444
(Registrant’s telephone number, including area code)
| N/A<br><br> <br>(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 7 .01 Regulation FD Disclosure.
On July 30, 2020, BioSig Technologies, Inc. (the “Company”) issued a press release, attached hereto as Exhibit 99.1, announcing that Kenneth L. Londoner, Chairman and Chief Executive Officer of the Company, will present at the Proactive Investors One2One Virtual Event on August 4, 2020. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.1.
On August 3, 2020, the Company issued a press release, attached hereto as Exhibit 99.2, announcing that that the Company has been awarded its Commercial and Government Entity (CAGE) code by the Systems for Award Management (SAM). The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.2.
On August 4, 2020, the Company issued a press release, attached hereto as Exhibit 99.3, announcing that that the Company installed its PURE EP(tm) System at Massachusetts General Hospital (MGH) as part of an expanding clinical study. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.3.
In accordance with General Instruction B.2 of Form 8-K, the information in this Item 7.01 of this Current Report on Form 8-K, including Exhibits 99.1, 99.2 and 99.3, shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set forth by reference in such a filing. Furthermore, the furnishing of information under Item 7.01 of this Current Report on Form 8-K is not intended to constitute a determination by the Company that the information contained herein, including the exhibits hereto, is material or that the dissemination of such information is required by Regulation FD.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit Number | Description |
|---|---|
| 99.1 | Press Release, dated July 30, 2020 |
| 99.2 | Press Release, dated August 3, 2020 |
| 99.3 | Press Release, dated August 4, 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: August 5, 2020 | By: | /s/ Kenneth L. Londoner |
|---|---|---|
| Name: Kenneth L. Londoner | ||
| Title: Executive Chairman |
ex_197349.htm
EXHIBIT 99.1
BioSig Technologies to Present at the Proactive Investors One2One Virtual Event on August 4, 2020
Westport, CT, July 30, 2020 (GLOBE NEWSWIRE) --
| ● | Update on the PURE EP(tm) System installations and commercial progress |
|---|---|
| ● | Update on Phase 2 clinical study of merimepodib in combination with remdesivir in adult patients with advanced COVID-19 |
| --- | --- |
BioSig Technologies, Inc. (Nasdaq: BSGM) (“BioSig” or the “Company”), 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, today announced that Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc. will present at the Proactive Investors One2One Virtual Event on August 4, 2020.
Event: Proactive Investors One2One Virtual Event
Date: Tuesday, August 4, 2020
Time: 1 PM ET
Registration link: https://www.proactiveinvestors.com/register/event_details/269
For more information on the presentation please contact Andrew Ballou, Vice President, Investor Relations at [email protected].
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 Pharmaceuticals, Inc. and Merimepodib (MMPD)
BioSig’s Technologies, Inc (Nasdaq: BSGM) subsidiary, ViralClear Pharmaceuticals, Inc. (ViralClear), is seeking to develop a novel pharmaceutical called merimepodib to treat patients with COVID-19. Merimepodib is intended to be orally administered, and has demonstrated broad-spectrum in vitro antiviral activity, including strong activity against SARS-CoV-2 in cell cultures. Merimepodib was previously in development as a treatment for chronic hepatitis C and psoriasis by Vertex Pharmaceuticals Incorporated (Vertex), with 12 clinical trials (7 in phase 1 and 5 in phase 2) with over 400 subjects and patients and an extensive preclinical safety package was completed.
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.
Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
54 Wilton Road, 2nd floor
Westport, CT 06880
203-409-5444, x133
ex_197350.htm
EXHIBIT 99.2
BioSig Awarded CAGE Code by the Systems for Award Management (SAM)
Company moves forward with the qualification to bid for contracts, grants and to do business with the U.S. government
Westport, CT, Aug. 03, 2020 (GLOBE NEWSWIRE) -- BioSig Technologies, Inc. (BSGM) (“BioSig” or the “Company”), 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, today announced that the Company has been awarded its Commercial and Government Entity (CAGE) code by the Systems for Award Management (SAM). The CAGE code is required to do business operations with the federal government.
BioSig, along with its subsidiary ViralClear, are now registered to conduct business with the U.S. government and can be sought out by government agencies for contracts that fit the Company. The CAGE code also includes the ability to apply and be awarded government contracts, assistance and grant programs.
About SAM
The System for Award Management (SAM) is a federal government owned and operated free website that consolidates the capabilities in Central Contractor Registration (CCR)/FedReg, Online Representations and Certifications Applications (ORCA) and the Excluded Parties List System (EPLS). Both current and potential government vendors are required to register in SAM in order to be awarded contracts by the government. SAM allows government agencies and contractors to search for companies based on ability, size, location, experience, ownership, and more. SAM allows users to search for firms certified by the SBA under the 8(a) Development and Hubzone Programs. SAM validates the vendor's information and electronically shares the secure and encrypted data with the federal agencies' finance offices to facilitate paperless payments through electronic funds transfer (EFT). Additionally, SAM shares the data with government procurement and electronic business systems.
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 Pharmaceuticals, Inc. and Merimepodib (MMPD)
BioSig’s Technologies, Inc (Nasdaq: BSGM) subsidiary, ViralClear Pharmaceuticals, Inc. (ViralClear), is seeking to develop a novel pharmaceutical called merimepodib to treat patients with COVID-19. Merimepodib is intended to be orally administered, and has demonstrated broad-spectrum in vitro antiviral activity, including strong activity against SARS-CoV-2 in cell cultures. Merimepodib was previously in development as a treatment for chronic hepatitis C and psoriasis by Vertex Pharmaceuticals Incorporated (Vertex), with 12 clinical trials (7 in phase 1 and 5 in phase 2) with over 400 subjects and patients and an extensive preclinical safety package was completed.
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.
Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
54 Wilton Road, 2nd floor
Westport, CT 06880
203-409-5444, x133
ex_197351.htm
EXHIBIT 99.3
BioSig Installs PURE EP(tm) System at Massachusetts General Hospital
Patient cases are set to commence in August
Westport, CT, Aug. 04, 2020 (GLOBE NEWSWIRE) -- BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company developing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced that the Company installed its PURE EP(tm) System at Massachusetts General Hospital (MGH) as part of an expanding clinical study.
The PURE EP(tm) System evaluation and data collection at MGH will commence under the leadership of investigator Moussa Mansour M.D., Director of MGH’s Cardiac Electrophysiology Laboratory and Atrial Fibrillation Program.
“Bringing our technology to a major EP institution on the east coast is a definite milestone in our clinical development. We look forward to working with Dr. Mansour and the entire MGH team as we pursue our mission of bringing advanced signal processing solutions to the field of electrophysiology,” commented Kenneth L. Londoner, Chairman, and CEO of BioSig Technologies, Inc.
BioSig is currently conducting patient cases under the clinical study titled, “Novel Cardiac Signal Processing System for Electrophysiology Procedures (PURE EP 2.0 Study)” at Texas Cardiac Arrhythmia Research Foundation (TCARF) in Austin, Texas and Mayo Clinic in Jacksonville, Florida.
The Shareholder Letter issued by the Company on April 17, 2020, announced that it received Institutional Review Board approvals to install its PURE EP(tm) System at several medical centers across the country for evaluation. All of these centers are high-volume clinical sites regarded for their work with new technologies.
“The market for atrial fibrillation is starting to open up again as patient cases are crucial for healthcare outcomes”, said Londoner.
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.
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.
Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
54 Wilton Road, 2nd floor
Westport, CT 06880
203-409-5444, x133