10-K: BioSig Technologies Faces Delisting Threat Despite Efforts to Regain Compliance
Sentiment:
Annual Results
BioSig Technologies reports its annual results on Form 10-K, highlighting ongoing efforts to regain Nasdaq compliance amidst financial challenges and a potential delisting.
Capital raiseThe company has engaged in several private placements and an ATM offering to raise capital, generating gross proceeds of $3,000,000 from a recent offering.BioSig entered into an equity subscription agreement with Lind Global Fund III, LP for up to $5.0 million.
Worse than expectedThe company is facing potential delisting from Nasdaq due to non-compliance with minimum bid price requirements.There is substantial doubt about BioSig's ability to continue as a going concern.The company has identified a material weakness in its internal control over financial reporting.
Summary
- BioSig Technologies, a medical device company focused on electrophysiology, filed its annual report on Form 10-K.
- The company is facing challenges related to Nasdaq listing compliance, including maintaining a minimum bid price and stockholders' equity.
- A delisting notice was received, and although the company regained compliance briefly, it is again facing potential delisting due to the bid price requirement.
- The company has implemented workforce reductions and management changes to reduce cash burn.
- BioSig is shifting its focus to research and development of software algorithms for pulsed field ablation.
- The company has engaged in several private placements and an ATM offering to raise capital.
- There is substantial doubt about the company's ability to continue as a going concern.
- The company's financial statements have been prepared assuming it will continue as a going concern, but it has incurred substantial operating losses.
- BioSig is dependent on raising additional capital to fund its operations.
- The company's PURE EP platform has received FDA 510(k) clearance, but further development and commercialization are needed.
- BioSig is collaborating with Mayo Clinic for research and development.
- The company is subject to extensive regulation by the FDA and other healthcare laws.
- The company has identified a material weakness in its internal control over financial reporting.
- As of April 14, 2025, BioSig had 5 full-time employees and 3 key consultants.
- The company's common stock is listed on the Nasdaq Capital Market under the symbol BSGM.
Sentiment
Score: 3
Explanation: The document presents a challenging financial situation for BioSig Technologies, with potential delisting from Nasdaq and concerns about its ability to continue as a going concern. While there are some positive developments, the overall tone is negative due to the significant financial and operational risks.
Positives
- BioSig has shifted its focus to research and development of software algorithms for pulsed field ablation, which may improve long-term outcomes.
- The company has engaged in several private placements and an ATM offering to raise capital.
- BioSig entered into an equity subscription agreement with Lind Global Fund III, LP for up to $5.0 million.
- The company's PURE EP platform has received FDA 510(k) clearance.
- The company has successfully met the qualifications to regain full compliance for continued listing on the Nasdaq Capital Market as of March 24, 2025.
Negatives
- BioSig Technologies is facing potential delisting from Nasdaq due to non-compliance with minimum bid price requirements.
- There is substantial doubt about BioSig's ability to continue as a going concern.
- The company has identified a material weakness in its internal control over financial reporting.
- The company has incurred substantial operating losses and has used cash in its operating activities for the past few years.
- The company has implemented workforce reductions to reduce annual cash burn.
Risks
- The company may be unable to develop its existing or future technology.
- The market for the company's technology and revenue generation avenues for its products may be slow to develop, if at all.
- The EP market is highly competitive.
- The company may fail to attract and retain qualified personnel.
- The company may face risks associated with future litigation and claims.
- The market price for the company's common stock may fluctuate significantly, which could result in substantial losses by investors.
- Future sales of the company's common stock in the public market or other financings could cause the stock price to fall.
- If the company sells additional equity or debt securities to fund its operations, it may impose restrictions on its business.
Future Outlook
The company expects to incur losses from operations for the near future and will require additional financing to fund future operations. The company plans to continue research and development of PURE EP and other applications of its core technology and raise capital through the sale of additional equity securities, debt, or strategic partnerships.
Industry Context
The global electrophysiology laboratory devices market size was estimated at USD 12.9 billion in 2024 and is projected to grow at a CAGR of 15.1% from 2025 to 2030. The company plans to capitalize on PURE EPs novel software modules for incorporation into other systems within the EP lab that display cardiac signals; at this time, we do not believe we have direct competition.
Comparison to Industry Standards
- The EP market is highly competitive with major players like GE Healthcare, Boston Scientific, Abbott Laboratories, and Medtronic.
- These companies offer electrophysiology recording systems with an average selling price of approximately $160,000 (source: DRG Medtech 360 Millennium report on EP Devices, issued in June 2019).
- The document suggests that BioSig's PURE EP system aims to offer superior signal quality compared to existing systems, potentially improving outcomes in complex arrhythmia ablation procedures.
Management Changes
| Role | Previous Person | New Person | Effective Date | Reason |
|---|---|---|---|---|
| Chief Executive Officer | Kenneth L. Londoner | Anthony Amato | 2024-04-30 | Resignation of previous CEO |
| Chief Financial Officer | Steve Buhaly | Ferdinand Groenewald (Interim) | 2024-06-05 | Resignation of previous CFO |
| Director | David Weild IV, Donald E. Foley, Patrick J. Gallagher, James J. Barry, James L. Klein, Frederick D. Hrkac | Christopher A. Baer, Steven E. Abelman, Donald F. Browne | 2024-02-19 | Resignation of previous directors |
Legal Proceedings
- The Company received a threat of litigation for the termination of employment with the Company alleging the termination of employment was in retaliation for bringing to the attention of the Companys board of directors and executives a series of wrongful and questionable practices by members of the Companys board of directors, Chief Executive Officer and Chief Financial Officer.
- The Company received a threat of litigation seeking restitution for losses resulting from unlawful actions taken by the Company and its board of directors.
- The Court filed an Order Granting Motion to Dismiss to the lawsuit filed on March 22, 2024 by plaintiff, Michael Gray Fleming (the Plaintiff), in Hennepin County, Minnesota District Court.
Related Party Transactions
- On March 7, 2024, the Company issued a promissory note to an investor and related party for $500,000.
- On May 1, 2024, the Company converted the promissory note and related accrued interest of $509,165 into 348,624 shares of common stock and warrants to purchase 174,312 shares of common stock at $1.398 per share.
Stakeholder Impact
- Shareholders face the risk of stock price volatility and potential delisting from Nasdaq.
- Employees have experienced workforce reductions.
- Customers may be affected by the company's financial instability and potential impact on product development and support.
- Suppliers and creditors face the risk of non-payment due to the company's financial challenges.
Next Steps
- The company will continue to focus on research and development of software algorithms for pulsed field ablation.
- BioSig will continue to seek additional financing to fund its operations.
- The company will work to regain compliance with Nasdaq listing requirements.
Key Dates
| Date | Description |
|---|---|
| 2009-02 | BioSig Technologies, Inc. was incorporated in Nevada. |
| 2011-04 | BioSig Technologies, Inc. re-incorporated in Delaware. |
| 2012-10-19 | Board of Directors of BioSig Technologies, Inc. approved the 2012 Equity Incentive Plan. |
| 2013-01-09 | Board of Directors authorized the issuance of up to 4,200 shares of 9% Series C Convertible Preferred Stock. |
| 2017-03-15 | BioSig entered into a know-how license agreement with Mayo Foundation for Medical Education and Research. |
| 2018-11-07 | BioSig formed a subsidiary, NeuroClear Technologies, Inc. (later renamed ViralClear Pharmaceuticals, Inc.). |
| 2019-09-24 | ViralClear's Board of Directors approved the 2019 Long-Term Incentive Plan. |
| 2019-11-20 | BioSig entered into a patent and know-how license agreement (the EP Software Agreement) with Mayo Foundation for Medical Education and Research. |
| 2020-07-02 | BioSig formed an additional subsidiary, NeuroClear Technologies, Inc., which was renamed to BioSig AI Sciences, Inc. on May 31, 2023. |
| 2023-12-27 | Board of Directors of BioSig Technologies, Inc. approved the 2023 Long-Term Incentive Plan. |
| 2024-01-28 | Management of the Company commenced a workforce reduction. |
| 2024-02-15 | Steve Buhaly resigned from his position as the Chief Financial Officer of the Company. |
| 2024-02-19 | David Weild IV, Donald E. Foley, Patrick J. Gallagher and James J. Barry, resigned from their positions as directors of the Company. |
| 2024-02-20 | James L. Klein and Frederick D. Hrkac resigned from their positions as directors of the Company. |
| 2024-02-27 | Frederick D. Hrkac was re-appointed as a director and the president and principal executive officer. |
| 2024-02-28 | The Company entered into a Equity Subscription Agreement with Lind Global Fund III, LP. |
| 2024-03-05 | The Company received a letter from the Staff at the Listing Qualifications Department of Nasdaq stating that the Company has not regained compliance with Listing Rule 5550(a)(2). |
| 2024-03-07 | The Company issued a promissory note to an investor and related party for $500,000. |
| 2024-03-11 | The Company submitted a request for a hearing before the Nasdaq Hearings Panel to appeal the Staffs delisting determination. |
| 2024-03-12 | The Company received a letter from the Staff stating that based upon the Staffs review of the Company and pursuant to Listing Rule 5101, the Staff believes that the Company no longer has an operating business and is a public shell. |
| 2024-04-30 | The board of directors appointed former advisory board member and consultant, Anthony Amato as a director, president, chief executive officer and principal executive officer. |
| 2024-05-01 | The Company converted the promissory note and related accrued interest of $509,165 into 348,624 shares of common stock and warrants to purchase 174,312 shares of common stock at $1.398 per share. |
| 2024-05-01 | The Company entered into a securities purchase agreement with certain accredited investors, pursuant to which the Company sold to the Investors an aggregate of 783,406 shares of the Common Stock at a purchase price of $1.4605 per share. |
| 2024-05-02 | The board of directors appointed Mr. Chris Baer as a director on the Board. |
| 2024-05-03 | The board of directors appointed Messrs. Steven E. Abelman and Donald F. Browne as directors on the board. |
| 2024-05-07 | The requested hearing before the Hearings Panel was held. |
| 2024-05-29 | The Company entered into a securities purchase agreement with certain institutional investors, pursuant to which the Company agreed to sell and issue to the investors (i) in a registered direct offering, 1,570,683 shares of Common Stock at a price of $1.91 per share and (ii) in a concurrent private placement, warrants to purchase up to an aggregate of 1,570,683 shares of Common Stock, at an exercise price of $1.78 per share. |
| 2024-06-05 | Frederick D. Hrkac resigned as acting chief financial officer and principal accounting officer of the Company. |
| 2024-06-05 | The Company and Ferdinand Groenewald entered into the Agreement effective June 5, 2024, pursuant to which Mr. Groenewald agreed to lead accounting and financial reporting activities of the Company. |
| 2024-06-10 | The Company received formal notice that the Nasdaq Hearings Panel had determined to delist the Companys common stock from Nasdaq. |
| 2024-06-12 | Trading in the Companys common stock was suspended on the Nasdaq Capital Market effective with the open of business. |
| 2024-06-24 | The Company was notified by Nasdaq that the Hearings Panel had declined to reconsider its decision dated June 10, 2024, to delist the Companys common stock from Nasdaq. |
| 2024-07-01 | The Company announced the intent to acquire the assets of Neuro-Kinesis Corporation (NKC). |
| 2024-07-10 | The Company filed a submission in support of an appeal to the Delisting Decision to the Nasdaq Listing and Hearing Review Council. |
| 2024-07-23 | The Company commenced trading of its common stock on the OTCQB, operated by OTC Markets Group, Inc. |
| 2024-10-18 | The Company was notified by the Staff that the Listing Council had granted the Company an exception through March 7, 2025, to evidence compliance with Nasdaq Listing Rule 5550(b). |
| 2024-10-23 | The Companys common stock resumed trading on the Nasdaq Capital Market. |
| 2024-10-24 | The Company received a letter from the Staff notifying the Company that based upon the closing bid price of the Companys common stock from the period of June 11, 2024 through the reinstatement date, October 23, 2024, the Company did not meet the minimum bid price of $1.00 per share required by the Rules. |
| 2024-12-18 | The Company entered into an At The Market Offering Agreement (the Sales Agreement) with H.C. Wainwright & Co., LLC. |
| 2025-02-03 | The Company terminated the LOI with Neuro-Kinesis Corporation. |
| 2025-03-05 | The Company entered into a securities purchase agreement with certain accredited investors pursuant to which the Company sold to the Investors an aggregate of 758,514 shares Common Stock at a purchase price of $1.07974 per share. |
| 2025-03-06 | The Company submitted supporting documents to the Listing Council evidencing compliance with the Equity Rule. |
| 2025-03-24 | The Company was notified by the Office of General Counsel of Nasdaq that the Company had successfully met the qualifications to regain full compliance for continued listing on the Nasdaq Capital Market. |
| 2025-04-11 | The Company received a letter from the Staff indicating that, based upon the closing bid price of the Companys common stock for the 30 consecutive business day period between February 27, 2025, through April 10, 2025, the Company did not meet the minimum bid price of $1.00 per share required for continued listing on Nasdaq pursuant to Nasdaq Listing Rule 5550(a)(2). |
| 2025-04-14 | As of April 14, 2025, there were 24,252,482 shares of the registrants common stock outstanding. |
Keywords
BioSig Technologies, PURE EP, Nasdaq, delisting, compliance, financial results, stock, warrants, equity, capital, funding, electrophysiology, ablation, medical device, research and development
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