S-1: Predictive Oncology Files S-1 for $10M Equity Line Amidst Nasdaq Delisting Threats and Going Concern Doubts

Sentiment:

Shelf Registration Statement 18 July 2025 5:10 PM

📋All filings for Predictive Oncology INC

Predictive Oncology Inc. has filed an S-1 registration statement to allow for the resale of up to 1.92 million shares by an institutional investor, potentially raising up to $10 million for the company, as it faces Nasdaq delisting for failing to meet listing standards and grapples with substantial doubt about its ability to continue as a going concern.

Delay expectedThe company was unable to complete its previously submitted plan of compliance for the Nasdaq stockholders' equity requirement within the 180-day extension period, leading to a delisting notice.The proposed merger with Renovaro, Inc. was extended once but ultimately terminated without a definitive agreement, indicating a delay or failure in a significant strategic transaction.

Capital raiseThe company has entered into a Standby Equity Purchase Agreement (SEPA) with Yorkville, providing the right to sell up to $10,000,000 of Common Stock to Yorkville over a 36-month period.Since May 2024, the company has raised approximately $3.9 million in net proceeds through at-the-market offerings of its Common Stock.Over the last 12 months, the company raised approximately $2.8 million in aggregate through cash exercises of outstanding warrants, a registered direct offering, and the sale of its STREAMWAY business.On February 19, 2025, the company completed a registered direct offering, selling 363,336 shares of Common Stock at $1.50 per share for gross proceeds of approximately $545,004.On March 17, 2025, the company sold 467,290 unregistered shares of Common Stock to Renovaro for $500,000.On June 3, 2025, the company sold 280,374 unregistered shares of Common Stock to an institutional investor for $300,000.The company explicitly states it requires significant additional funding to maintain operations and implement its business plan, and is evaluating alternatives including equity financing, issuing debt, or other financing arrangements.

Worse than expectedThe company has incurred significant and recurring losses from operations for several years, with an accumulated deficit of $182,869,144 as of March 31, 2025.It reported negative cash flows from continuing operating activities of $10,974,568 for the year ended December 31, 2024, and $985,840 for the three months ended March 31, 2025.The company's auditors have expressed substantial doubt about its ability to continue as a going concern.The company is facing multiple Nasdaq delisting threats due to non-compliance with both the minimum stockholders' equity requirement ($1,966,969 vs. $2.5 million required) and the minimum bid price requirement ($0.78 vs. $1.00 required).A previously planned merger with Renovaro, Inc. terminated, and the company is now facing a lawsuit from Renovaro seeking to compel the merger.

Summary

Predictive Oncology Inc. filed an S-1 registration statement to register for resale up to 1,921,706 shares of Common Stock by YA II PN, LTD. (Yorkville).
The shares include 120,482 commitment shares issued to Yorkville for entering the Standby Equity Purchase Agreement (SEPA) and up to 1,801,224 shares that may be issued to Yorkville under the SEPA.
The company will not receive any proceeds from the resale of shares by Yorkville, but may receive up to $10,000,000 in aggregate gross proceeds from sales of Common Stock it elects to make to Yorkville under the SEPA.
The per share purchase price for sales to Yorkville will be the volume weighted average price (VWAP) less a 4.0% discount.
The company is facing Nasdaq delisting due to non-compliance with the minimum $2,500,000 stockholders' equity requirement and the minimum $1.00 bid price requirement.
An oral hearing with Nasdaq's Hearings Panel was held on July 17, 2025, where the company presented plans to regain compliance, including continued at-the-market offerings, SEPA sales, expanding its ChemoFx assay, business collaborations, and a potential reverse stock split.
The company had an accumulated deficit of $182,869,144 and cash and cash equivalents of $3,087,588 as of March 31, 2025.
Negative cash flows from continuing operating activities were $10,974,568 for the year ended December 31, 2024, and $985,840 for the three months ended March 31, 2025.
There is substantial doubt about the company's ability to continue as a going concern, as stated by its auditors.
The company's proposed merger with Renovaro, Inc. terminated on March 31, 2025, and Renovaro filed a lawsuit on May 8, 2025, seeking to compel the merger, which the company plans to contest.
The company's business focuses on applying artificial intelligence (AI) to oncology drug discovery, utilizing a proprietary biobank of 150,000 tumor samples and 3D cell culture models, and offering clinical testing services through its Helomics subsidiary.
The SEPA limits share issuance to Yorkville to 1,921,706 shares (19.99% of outstanding shares) unless stockholder approval is obtained or the average sale price equals or exceeds $0.83 per share.
Yorkville's beneficial ownership is capped at 4.99% of outstanding voting power or shares.
The company has 10,222,221 shares of Common Stock outstanding as of July 17, 2025.
The estimated expenses for this registration statement are $145,233.

Sentiment

Score: 2

Explanation: The company faces severe financial distress, including recurring losses, negative cash flow, and an accumulated deficit. It is under immediate threat of Nasdaq delisting on multiple fronts and its auditors have expressed substantial doubt about its ability to continue as a going concern. While the SEPA offers a potential funding source, it comes with significant dilution risk, and the company's strategic merger attempt failed, leading to litigation. The underlying business in AI-driven oncology is promising, but the current financial and operational challenges are critical.

Positives

The company has secured a Standby Equity Purchase Agreement (SEPA) with Yorkville, providing access to up to $10,000,000 in gross proceeds, which can be used for working capital and general corporate purposes.
The company's core business leverages artificial intelligence (AI) and a large proprietary biobank of 150,000 tumor samples to improve oncology drug discovery, which is a growing market driven by demand for AI-empowered solutions.
The PEDAL platform aims to increase the probability of clinical success, decrease development time and cost, and enable patient diversity early in the drug discovery process.
The FDA Modernization Act 2.0, allowing alternatives to animal testing, is expected to increase the market for the company's non-animal testing methods like cell-based assays and computer models.
The company continues to explore various alternatives to regain and maintain Nasdaq listing compliance, including business collaborations and expanding its ChemoFx drug response assay.

Negatives

The company has incurred significant and recurring losses from operations for several years and had an accumulated deficit of $182,869,144 as of March 31, 2025.
There is substantial doubt about the company's ability to continue as a going concern, as highlighted by its auditors.
The company received a delisting notice from Nasdaq on June 9, 2025, for failing to meet the minimum $2,500,000 stockholders' equity requirement.
On July 8, 2025, the company received another Nasdaq notice for non-compliance with the minimum $1.00 bid price requirement, as its stock closed below $1.00 for 30 consecutive business days.
The previously proposed merger with Renovaro, Inc. terminated, and Renovaro subsequently filed a lawsuit against the company seeking to compel the merger, which the company plans to contest.
The company does not expect to generate sufficient operating revenue to sustain its operations in the near term and requires significant additional capital.
Any future financing, including sales under the SEPA, may be highly dilutive to existing stockholders.
The company's inability to access the full amount available under the SEPA, or a delisting from Nasdaq, could materially adversely affect its liquidity.
The sale of shares by Yorkville under the SEPA, or the perception of such sales, could cause the company's stock price to fall and result in substantial dilution to existing stockholders.
The company has short-term obligations of $4,609,043 as of March 31, 2025, exceeding its cash and cash equivalents of $3,087,588.

Risks

Inability to continue operating without additional financing.
Continued negative operating cash flows.
Capital needs to accomplish goals, including further financing, which may be highly dilutive and include onerous terms.
Risks and uncertainties related to the ability to regain compliance with Nasdaq continued listing standards in the required timeframe.
Risks related to recent and future acquisitions, including benefits and costs.
Risks related to partnerships with other companies, including the need to negotiate definitive agreements, possible failure to realize anticipated benefits, and costs of providing funding to partner companies.
Risks related to the initiation, formation, or success of collaboration arrangements, commercialization activities, product sales levels by collaboration partners, and future payments due.
Inability to protect intellectual property or claims of infringing on others' intellectual property.
Impact of competition.
Acquisition and maintenance of any necessary regulatory clearances applicable to technology applications.
Inability to attract or retain qualified senior management personnel, including sales and marketing personnel.
Risk of never becoming profitable if products and services are not accepted by potential customers.
Possible impact of government regulation and scrutiny.
Unexpected costs and operating deficits, and lower than expected sales and revenues.
Adverse results of any legal proceedings.
Volatility of operating results and financial condition.
Challenges in managing growth.
Material adverse effects on business and operations due to disruptions caused by economic and geopolitical uncertainties, epidemics, or pandemics.
Inability to predict the actual number of shares sold under the SEPA or the actual gross proceeds.
Inability to access the full amount available under the SEPA if Nasdaq delisting occurs.
Investors buying shares at different times may pay different prices and experience different investment outcomes.
Future sales made by the company to Yorkville at lower prices could cause a decline in the value of shares purchased by investors.
Management's broad discretion over the use of net proceeds from SEPA sales, which may not be invested successfully.
Pursuit of alternatives to obtain additional funding or avoid delisting could change the nature of the business or investment, or cause SEPA termination.
Uncertain impact of a reverse stock split on future market price and Nasdaq listing maintenance.
Future equity offerings may cause additional and potentially substantial dilution.
No anticipated cash dividends; capital appreciation is the sole source of gain.
Shares eligible for future sale may adversely affect the market price.
Board of directors' ability to issue undesignated preferred stock and existence of anti-takeover provisions may depress Common Stock value.
Stock price volatility, leading to potential loss of investment.

Future Outlook

The company aims to leverage and expand its portfolio of proprietary AI-driven solutions to advance drug discovery and enable oncology drug development for biopharma partners. It believes its PEDAL platform can significantly increase the probability of clinical success, decrease time and cost in oncology drug discovery, and prioritize drug candidates while accounting for patient tumor diversity. The company expects the market for AI-powered drug discovery to continue to grow, partly due to the FDA Modernization Act 2.0, which allows for alternatives to animal testing. The company continues to evaluate alternatives to obtain additional funding and regain Nasdaq listing compliance, which may include further equity financing, debt, or strategic transactions like mergers or acquisitions.

Management Comments

We do not believe the lawsuit filed by Renovaro has merit and plan to contest it vigorously.
We intend to continue actively monitoring the bid price for our Common Stock and will consider available options to resolve the deficiency and regain compliance with the Minimum Bid Price Requirement, which may include effecting a reverse stock split.
We are awaiting the Panel's decision related to the Company's request and continue to evaluate other alternatives to regain and maintain compliance with the continued listing standards.
There can be no assurance that the Company's request to continue listing will be accepted or that if it is, the Company will be able to maintain compliance with requirements for its continued listing on The Nasdaq Capital Market.
The decision to pursue and enter into any such transaction will be made by management and our Board of Directors based on determinations of what is in the best interest of the Company and its stockholders.

Industry Context

The company operates in the rapidly evolving oncology drug discovery and development sector, which is increasingly adopting AI-empowered solutions to enhance efficiency, reduce cycle times, and improve accuracy. The growing demand for novel drug therapies and the shift towards more efficient, accurate, and predictive models, partly driven by legislative changes like the FDA Modernization Act 2.0 (allowing non-animal testing methods), are fueling market growth. Predictive Oncology aims to position its PEDAL platform as a unique solution for early insights, drug prioritization, and repurposing, addressing a key unmet need for actionable multi-omic insights in the pharmaceutical, diagnostic, and biotech industries.

Comparison to Industry Standards

The document does not provide specific comparable companies, projects, or results to assess the company's performance against global benchmarks or industry standards. It highlights the company's unique position with its proprietary biobank and AI platform but lacks direct comparative financial or operational data against competitors in the AI-driven drug discovery or clinical testing space.

Corporate Governance

Change Type	Description	Effective Date	Impact Assessment
Bylaws Advance Notice Provisions	Sections 2.09 and 2.10 of the Bylaws contain advance-notice provisions for shareholders to raise business or nominate directors at meetings, requiring submission within a specified period prior to a meeting.	Not specified, but effective as of September 9, 2022 (date of Second Amended and Restated Bylaws).	Intended to enhance continuity and stability of corporate policies and ensure the Board has sufficient time to act, but could delay or frustrate removal of incumbent directors or takeover attempts.
Bylaws Number of Directors and Vacancies	Bylaws state the exact number of directors is determined by Board resolution, divided into three classes. Vacancies and newly created directorships can be filled solely by a majority of directors then in office.	Not specified, but effective as of September 9, 2022 (date of Second Amended and Restated Bylaws).	Could delay or frustrate the removal of incumbent directors or the assumption of control by a large block holder, and discourage mergers or proxy contests.
Delaware Law Section 203	The company is subject to Section 203 of the Delaware General Corporation Law, which prohibits business combinations with interested stockholders (beneficially owning 15% or more of voting stock) for three years, unless certain conditions are met.	Ongoing, as a Delaware corporation.	Could delay or frustrate the removal of incumbent directors or a change in control, and discourage, impede, or prevent a merger, tender offer, or proxy contest, even if favorable to stockholders.
Authorized Capital Preferred Stock	The Board of Directors has the authority to designate and issue up to 20,000,000 shares of preferred stock in one or more series, and to fix their rights, preferences, and privileges without stockholder approval.	Ongoing.	Could make it more difficult for a third party to acquire control of the company and discourage such attempts, potentially depressing the value of Common Stock.

Legal Proceedings

On May 8, 2025, Renovaro, Inc. filed a lawsuit in Delaware Chancery Court claiming breaches by Predictive Oncology Inc. of the Letter of Intent and Extension Agreement related to the proposed merger, and seeking to compel the company to enter into a merger agreement with Renovaro. The company does not believe the lawsuit has merit and plans to contest it vigorously.

Related Party Transactions

On March 13, 2025, the company executed a share subscription agreement with Renovaro, Inc. (NASDAQ: RENB), a party with whom it had a binding letter of intent for a proposed merger, and sold 467,290 unregistered shares of Common Stock to Renovaro at a price of $1.07 per share for a total purchase price of $500,000.

Stakeholder Impact

**Shareholders**: Face significant dilution risk from potential future equity offerings, including sales under the SEPA. May experience a decline in stock price due to sales by Yorkville or the perception of such sales. Risk of losing all or part of their investment due to substantial doubt about the company's going concern ability and potential Nasdaq delisting. Economic and voting interests will be diluted.
**Employees**: The company's financial instability and going concern issues could impact job security, compensation, and morale. Inability to attract or retain qualified senior management personnel, including sales and marketing personnel, is a stated risk.
**Customers/Partners (Biopharma clients)**: The company's financial health and Nasdaq listing status could affect its perceived stability and ability to deliver on long-term collaborations and services, potentially impacting trust and future business relationships.
**Creditors**: The company's significant accumulated deficit, negative cash flows, and substantial doubt about its going concern ability increase the risk for creditors regarding repayment of short-term and long-term obligations.
**Regulatory Authorities (SEC, Nasdaq)**: The company is under scrutiny from Nasdaq for non-compliance with listing rules, requiring ongoing efforts and potential actions (like reverse stock split) to maintain listing. Non-compliance could lead to delisting, impacting market integrity.

Next Steps

Await Nasdaq Hearings Panel's decision regarding the appeal for continued listing and requested exception through December 8, 2025.
Continue to evaluate alternatives to regain and maintain compliance with Nasdaq listing standards, including a potential reverse stock split.
Potentially elect to sell shares of Common Stock to Yorkville under the SEPA to raise up to $10,000,000 in gross proceeds.
Contest the lawsuit filed by Renovaro, Inc. in Delaware Chancery Court.
File additional registration statements with the SEC if more than 1,921,706 shares need to be sold under the SEPA to reach the $10,000,000 aggregate gross proceeds.
Potentially seek stockholder approval to issue shares in excess of the Nasdaq Exchange Cap (19.99% of outstanding shares) under the SEPA, if the average sale price is below $0.83 per share.
Continue to seek ways to generate revenue through business development activities and improve operating margin.
Management will have broad discretion over the use of net proceeds from SEPA sales for general corporate purposes and working capital, potentially including capital expenditures, licensing/acquiring intellectual property, or investments/acquisitions.

Key Dates

Date	Description
2002-04-23	Company originally incorporated in Minnesota.
2013	Company reincorporated in Delaware.
2015-08-31	Closing date of an offering of units where Series B Convertible Preferred Stock was issued.
2016-02-29	Series B Convertible Preferred Stock separated from other securities included within the units and became convertible.
2018-02-01	Company changed its name from Skyline Medical Inc. to Precision Therapeutics Inc.
2019-06-13	Company changed its name from Precision Therapeutics Inc. to Predictive Oncology Inc.
2022-05-13	Received Nasdaq letter for non-compliance with minimum $1.00 bid price requirement.
2022-11-09	Original deadline to regain Nasdaq bid price compliance.
2023-04-23	Effected a 20-for-1 reverse stock split to cure Nasdaq bid price deficiency.
2023-12-31	Fiscal year end for which BDO USA, P.C. audited consolidated financial statements.
2024-05-01	Approximate start date for at-the-market offerings that raised $3.9 million net proceeds.
2024-07-25	Entered into definitive agreements with warrant holders for exercise of warrants.
2024-07-26	Closing date for warrant exercise transactions.
2024-08-13	Date as of which 79,246 shares of Series B Convertible Preferred Stock remained outstanding.
2024-09-19	Received another Nasdaq letter for not meeting the Minimum Bid Price Requirement.
2024-11-20	Received Nasdaq letter for non-compliance with minimum stockholders' equity requirement ($1,966,969 as of Sep 30, 2024, below $2.5 million).
2024-12-31	Fiscal year end for which KPMG LLP audited consolidated financial statements.
2025-01-01	Entered into a binding letter of intent (LOI) with Renovaro, Inc. for acquisition.
2025-01-05	Deadline to regain compliance with Minimum Bid Price Requirement (180 days from July 8, 2025 notice).
2025-01-06	Submitted plan to Nasdaq to regain stockholders' equity compliance, citing Renovaro merger.
2025-02-18	Entered into a Securities Purchase Agreement for a registered direct offering.
2025-02-19	Closing date for the registered direct offering.
2025-02-28	Entered into an extension agreement with Renovaro, extending LOI termination to March 31, 2025.
2025-03-13	Executed a share subscription agreement with Renovaro.
2025-03-17	Closing date for share issuance to Renovaro.
2025-03-18	Deadline to regain Nasdaq bid price compliance (180 days from Sep 19, 2024 notice).
2025-03-31	LOI with Renovaro terminated; fiscal quarter end for which financial statements are reported.
2025-04-03	Board of Directors notified Renovaro of decision to discontinue merger discussions.
2025-05-08	Renovaro filed a lawsuit in Delaware Chancery Court against the company.
2025-05-13	Executed a share subscription agreement with an institutional and accredited investor.
2025-06-03	Closing date for share issuance to institutional investor.
2025-06-09	Received Nasdaq delisting letter for not regaining stockholders' equity compliance.
2025-06-11	Submitted hearing request to Nasdaq's Hearings Panel, staying delisting.
2025-06-12	Notified that Nasdaq Panel agreed to consider appeal at oral hearing.
2025-07-01	Entered into the Standby Equity Purchase Agreement (SEPA) with Yorkville.
2025-07-03	Issued 120,482 shares of Common Stock to Yorkville upon SEPA execution.
2025-07-08	Received Nasdaq letter for non-compliance with minimum $1.00 bid price requirement.
2025-07-11	Date used for calculating the registration fee based on average high and low stock prices ($0.8074).
2025-07-17	Last reported sale price of Common Stock on Nasdaq was $0.78 per share; attended oral hearing with Nasdaq Panel.
2025-07-18	Date of S-1 filing and prospectus.
2025-12-08	Requested exception period from Nasdaq for continued listing standards.

Recommendation

strong sell

Keywords

Oncology, Artificial Intelligence, Drug Discovery, Cancer Therapies, Biobank, 3D Cell Culture Models, Clinical Testing, ChemoFx, BioSpeciFx, Nasdaq Listing, SEC Filing, S-1, Equity Financing, Dilution, Going Concern, Biopharma, Medical Technology, Predictive Oncology

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