UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
(Exact name of registrant as specified in its charter)
| | |
(State or other jurisdiction | (Commission File Number) | (IRS Employer |
of incorporation) |
| Identification No.) |
|
| |
(Address of principal executive offices) |
| (Zip Code) |
(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:
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
| Trading Symbol(s) |
| Name of exchange on which registered |
|
| |
|
|
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 October 26, 2020, BioSig Technologies, Inc. (the “Company”) issued a press release, attached hereto as Exhibit 99.1, announcing that ViralClear Pharmaceuticals, Inc., the Company’s majority-owned subsidiary, has halted its signal finding Phase 2 trial, “A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Oral Merimepodib in Combination with Intravenous Remdesivir in Adult Patients with Advanced Coronavirus Disease 2019 (COVID-19).” The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.1.
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 Exhibit 99.1, 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 |
|
|
104 |
|
Cover Page Interactive Data File (formatted as Inline XBRL) |
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: October 26, 2020 |
By: |
/s/ Kenneth L. Londoner |
|
|
|
Name: Kenneth L. Londoner |
|
|
|
Title: Executive Chairman |
|
Exhibit 99.1
ViralClear halts its Phase 2 Hospitalized COVID-19 Trial
Westport, CT, Oct. 26, 2020 (GLOBE NEWSWIRE) -- BioSig Technologies, Inc. (Nasdaq: BSGM) (“BioSig” or the “Company”) and its majority owned subsidiary, ViralClear Pharmaceuticals, Inc. (ViralClear), announced the halting of its signal finding Phase 2 trial, “A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Oral Merimepodib in Combination with Intravenous Remdesivir in Adult Patients with Advanced Coronavirus Disease 2019 (COVID-19)”.
After the implementation of a protocol amendment that expanded the size of the trial from 40 to 80 hospitalized COVID-19 patients, and that limited enrollment to seriously ill patients, (NIAID Grade 3, who required high flow, high concentration oxygen to maintain adequate oxygenation) the Safety Monitoring Committee (SMC) was unblinded for safety reasons since these patients are at higher risk for dying from their disease. At the time of the most recent review of the data by the SMC, 44 patients had been enrolled in the trial of whom 42 had received study drug (either merimepodib solution or matching placebo). This most recent review of the data documented all 22 Grade 4 patients were discharged from the hospital and did not relapse during the 37 day follow-up period. However, patients who were NIAID Grade 3 patients (n = 20) at the time of enrollment had markedly different outcomes. Specifically, the unblinded SMC detected an imbalance in survival rates in these NIAID Grade 3 patients between the placebo and merimepodib making it unlikely that the trial would meet its primary safety endpoints. The company has therefore elected to stop enrollment into the clinical trial. Patients will be followed as per the protocol for safety monitoring; however, no further study drug treatments will be administered.
At this time, the Company does not intend to further develop merimepodib. However, the Company will see if other parties are interested in acquiring or licensing merimepodib.
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
aballou@biosigtech.com
203-409-5444, x133
Document And Entity Information |
Oct. 26, 2020 |
---|---|
Document Information Line Items | |
Entity Registrant Name | BioSig Technologies, Inc. |
Trading Symbol | BSGM |
Document Type | 8-K |
Amendment Flag | false |
Entity Central Index Key | 0001530766 |
Document Period End Date | Oct. 26, 2020 |
Entity Emerging Growth Company | false |
Entity Incorporation, State or Country Code | DE |
Entity File Number | 001-38659 |
Entity Tax Identification Number | 26-4333375 |
Entity Address, Address Line One | 54 Wilton Road, 2nd Floor |
Entity Address, City or Town | Westport |
Entity Address, State or Province | CT |
Entity Address, Postal Zip Code | 06880 |
City Area Code | (203) |
Local Phone Number | 409-5444 |
Written Communications | false |
Soliciting Material | false |
Pre-commencement Tender Offer | false |
Pre-commencement Issuer Tender Offer | false |
Title of 12(b) Security | Common Stock, par value $0.001 per share |
Security Exchange Name | NASDAQ |
N^V*$OE=5_\.2(>:GWO"!3)H\X^&W/+["$[_![1S!1"J1!S7
M80=D0$6/.SBD3_14]BG(QH^'K,/_A="]A?3]X_=\X6".QNJ[6 >)3O=K[Z[I_OAGZUS[[LO__8N_K2L[MW-SOO
MO2]^?M3?O6XSO3%T_LJ.AY5S4PQ=KUI]5VF:K?;HK!Q<>=FT\%63=."OS<
M/A.W7ZLW\KSY5K^5K=OBN[W>T=%_2+75U#0E;%N$1-1BBO5E]=7D2Q[=YHLU
MBTA^MO"5B=7&V:R,S'>>@,K.P4K #VL=YN!+GPH?X]6R>M^>H6NYR?#39R0:
M/C$7ZX%.\9,D-A/(*,PSHA-+VD2PLDD; >UCJY+%%]3!+WRG7?G_ 5!+ P04
M " "E=5I1M5(YR$@$ "E#0 $0 &)S9VTM,C R,#$P,C8N>'-DO5=;
M<]HZ$'[OK]#Q4\]TC&T(Y, $.A3:A!22AEM(.IV.+ H\N
MP)\IT]>F&J))?]YSD.]^@\!Q^)Z9_ (-;D.>Z[]!4R.F[BBZ>S&7A,UT'"
M2S&3/KQZ#4[I#+8L9&DRE1 R-G22*"VX;*"5\@M(Y:U82LCAZ$(6F71JJ2QO
M/5-B[S-9AB*L6IM)*$A8?"X][3LYR3K;",KEU
M[IFTL8@B/,YF]L,SJ].=C>53EQECK;G+I=%;ENI&IKA6J@NJ4DJM\:#CVMN8
M*EZ=YB^;XKG,WCHI?AF=@6/QH@ &;MCG(/-3*SC/A%5/!:Q3
YTG=1(C4O3=F4@
M6&;=988;X$%=J3MF9BKZTN3!0C.RC8803ZWD](-JO.+")^/@#;A7,@ [2L&D
MXB$U 0:=2I8FU/
KZES5AN.]S9P>>-G\>ZL-77MC9'Y
MF+=_D/)P=.K^:%T>P ,XWI]^+W__>;?>6!^T1V9M>_M H,^E_4$L#!!0
M ( *5U6E$[^>21H 4 /$K 5 8G-G;2TR,#(P,3 R-E]P