GRDX US Equity☆

GRIDAI TECHNOLOGIES CORP_December 31, 2025

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 10-K

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☒ ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

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For the fiscal year ended December 31, 2025

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For the transition period from to

Commission file Number 001-37853

GRIDAI TECHNOLOGIES CORP

(Exact name of registrant as specified in its charter)

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433 Plaza Real, Suite 275, ​ ​ ​ ​

Boca Raton, Florida ​ 33432

(Address of principal executive offices) ​ (Zip Code)

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(561) 589-7020

(Registrant’s telephone number, including area code)

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

Common stock, par value $0.0001 per share GRDX The Nasdaq Capital Market

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Securities registered under Section 12(g) of the Act: None

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐No☒

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐No☒

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer ☐ Accelerated filer ☐

Non-accelerated filer ☒ Smaller reporting company ☒

Emerging growth company ☐

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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. ☐

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued statements. ☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to § 240.10D-1(b). ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒

The aggregate market value of common stock held by non-affiliates of the registrant, based on the closing price of a share of the registrant’s common stock on June 30, 2025, which is the last business day of the registrant’s most recently completed second fiscal quarter, as reported by The Nasdaq Capital Market on such date, was approximately $14.9 million.

There were 6,200,051 shares of the registrant’s common stock, par value $0.0001 per share (the “Common Stock”), outstanding as of May 1, 2026.

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GRIDAI TECHNOLOGIES CORP

ANNUAL REPORT ON FORM 10-K

YEAR ENDED DECEMBER 31, 2025

TABLE OF CONTENTS

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PART I 1

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Item 1. Business 1

Item 1A. Risk Factors 20

Item 1B. Unresolved Staff Comments 56

Item 1C. Cybersecurity 56

Item 2. Properties 57

Item 3. Legal Proceedings 57

Item 4. Mine Safety Disclosures 57

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Item 6. Reserved 59

Item 7A. Quantitative and Qualitative Disclosures About Market Risk 69

Item 8. Financial Statements and Supplementary Data 69

Item 9A. Controls and Procedures 71

Item 9B. Other Information 72

Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 72

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PART III 73

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Item 10. Directors, Executive Officers and Corporate Governance 73

Item 11. Executive Compensation 78

Item 14. Principal Accountant Fees and Services 88

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Item 15. Exhibits and Financial Statement Schedules 89

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Signatures 93

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Index to Consolidated Financial Statements F-1

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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Annual Report on Form 10-K, or this Annual Report, contains forward-looking statements that involve substantial risks and uncertainties. All statements contained in this Annual Report other than statements of historical fact are forward-looking statements, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market opportunities or growth. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to differ materially from any future results, performance or achievements expressed or implied by the forward-looking statements.

The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

These forward-looking statements include, among other things, statements regarding:

● the availability of capital to satisfy our working capital requirements

● our ability to continue operating as a going concern

● our ability to operate, develop and expand the Grid AI and AMPX business

● regulatory developments in the United States and foreign jurisdictions

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Factors that may cause actual results to differ materially from current expectations include, among other things, the risks and uncertainties described under Part I, Item 1A, “Risk Factors,” and elsewhere in this Annual Report. Any forward-looking statement in this Annual Report reflects our current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to our operations, results of operations, financial condition, industry and growth strategy. Given these uncertainties, you should not place undue reliance on these forward-looking statements as predictions of future events.

Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Except as required by law, we undertake no obligation to update or revise any forward-looking statements contained in this Annual Report to reflect new information, future events or circumstances, or otherwise.

This Annual Report also contains estimates, projections and other information concerning our industry, our business and the markets for certain products, technologies and product candidates, including data regarding estimated market size, projected growth rates and the prevalence of certain conditions. Information that is based on estimates, forecasts, projections or similar methodologies is inherently subject to uncertainties, and actual events or circumstances may differ materially from those reflected in such information. Unless otherwise expressly stated, we obtained these industry, business, market and other data from reports, research surveys, studies and similar data prepared by third parties, industry, medical and general publications, government data and similar sources. We have not independently verified the data obtained from third-party sources, and in some cases we do not expressly identify the sources from which such data are derived.

In this Annual Report, unless otherwise stated or the context otherwise requires, references to “GridAI,” the “Company,” “we,” “us,” “our” and similar references are to GridAI Technologies Corp. and its subsidiaries on a consolidated basis. References to “FWB” refer to First Wave Bio, Inc., a wholly owned subsidiary of the Company. Reference to “Grid AI Corp.” refer to Grid AI Corp., a Nevada corporation and our wholly owned subsidiary. Reference to “AMPX” refer to AMPX UK Holdings, a Cayman Islands company of which Grid AI holds 75% ownership interest. References to “IMGX” refer to ImmunogenX, LLC (formerly ImmunogenX, Inc.), which was previously a wholly owned subsidiary of the Company and was disposed of on December 31, 2025 in connection with the rescission transaction.

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PART I

ITEM 1.BUSINESS

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Overview

GridAI Technologies Corp., formerly known as Entero Therapeutics, Inc., is a diversified technology and life sciences company operating through two principal areas: (i) energy orchestration and grid optimization software solutions through our subsidiary Grid AI Corp. and (ii) legacy biopharmaceutical development activities centered on Adrulipase for the treatment of exocrine pancreatic insufficiency. Effective December 1, 2025, the Company changed its name from “Entero Therapeutics, Inc.” to “GridAI Technologies Corp.” and changed its Nasdaq trading symbol from “ENTO” to “GRDX.”

On September 30, 2025, the Company completed a share exchange transaction pursuant to which it acquired 100% of the outstanding equity interests of Grid AI Corp., a Nevada corporation. At the time of the acquisition, Grid AI Corp. owned 75% of the issued and outstanding equity interests of AMPX UK Holdings, a Cayman Islands company, which holds the operating subsidiary AMPX Limited. Following the transaction, Grid AI Corp. and its subsidiaries, including AMPX, became consolidated subsidiaries of the Company.

Grid AI Corp. develops software and services designed to accelerate power availability and optimize energy infrastructure for artificial intelligence (AI) data centers and other large energy users. Grid Ai Corp. is currently in the development stage of an AI data center platform. This platform aims to use and optimize distributed energy resources, including battery energy storage systems, on-site generation, and grid interconnections. Currently, there is no revenue generated from this AI data center platform. Grid Ai Corp.’s commercial pipeline has recently been re-established and is continuing to develop through consulting-led engagements and targeted business development initiatives.

For the year ended December 31, 2025, the Company’s consolidated financial statements include the post-acquisition results of Grid AI Corp. and AMPX beginning on September 30, 2025. Prior to the Grid AI Corp. acquisition, the Company operated primarily as a clinical-stage biopharmaceutical company focused on targeted, non-systemic therapies for gastrointestinal diseases. Non-systemic therapies are non-absorbable drugs that act locally, such as in the intestinal lumen, skin or mucosa, without reaching an individual’s systemic circulation. In May 2024, the Company changed its name from First Wave BioPharma, Inc. to Entero Therapeutics, Inc.

The Company’s continuing legacy biopharmaceutical focus is Adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients in patients with exocrine pancreatic insufficiency, including patients with cystic fibrosis and chronic pancreatitis. The Company plans to continue development activities relating to Adrulipase. The Company’s former Latiglutenase and CypCel programs were part of the ImmunogenX business, which was disposed of on December 31, 2025 in connection with the rescission transaction described below. The Company has also discontinued its Capeserod and Niclosamide programs. The Company terminated its license agreement with Sanofi relating to Capeserod on February 26, 2025 and no further payments were due thereunder.

In March 2025, the Company entered into a rescission agreement with ImmunogenX, LLC, formerly a wholly owned subsidiary of the Company, and the former shareholders of ImmunogenX. Under the rescission transaction, the parties agreed to unwind the Company’s prior acquisition of ImmunogenX by rescinding the previously issued Common Stock and Series G Preferred Stock issued in the transaction, conveying the equity interests of ImmunogenX back to the former ImmunogenX shareholders, and canceling the assumed ImmunogenX options and warrants. The Company retained approximately $695,814 of ImmunogenX accounts payable, while ImmunogenX remained responsible for approximately $9.3 million of secured debt and certain other obligations. The rescission transaction closed on December 31, 2025. Following the closing, ImmunogenX ceased to be a subsidiary of the Company, and the Company no longer held any ownership interest in that business.

As a result, as of December 31, 2025, the Company’s operations consist of (i) its newly acquired subsidiary, Grid AI Corp., and (ii) its continuing Adrulipase development program, which is conducted through its wholly owned subsidiary, First Wave Bio, Inc., together with related corporate activities.

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Our Grid Optimization Software Solutions

Grid AI Corp. develops software and services designed to accelerate power availability and optimize energy infrastructure for artificial intelligence (AI) data centers and other large energy users. Grid Ai Corp. is currently in the development stage of an AI data center platform. This platform aims to use and optimize distributed energy resources, including battery energy storage systems, on-site generation, and grid interconnections. Currently, there is no revenue generated from this AI data center platform. Grid Ai Corp.’s commercial pipeline has recently been re-established and is continuing to develop through consulting-led engagements and targeted business development initiatives. Current discussions are primarily with battery energy storage system (BESS) providers and energy infrastructure participants, including companies such as Mango Power and Nomad Transportable Power Systems. While prior trial deployments, including in Australia, have not yet resulted in significant commercial revenue, these efforts have informed management’s strategy to focus on lower-friction, near-term opportunities that can be pursued with limited incremental cost. Market conditions vary significantly by geography, and the Company is prioritizing regions and use cases where its platform can be more readily adopted. Grid Ai Corp. does not have any major customers at the present time and in the future aims to primarily serve AI data center developers, hyperscalers (large-scale cloud service providers that operate extensive computing, storage, and networking infrastructure to support enterprise applications and AI workloads), and energy infrastructure developers in North America and Australia.

Notwithstanding the early-stage nature of commercialization, Grid AI Corp. continues to prioritize development of its data center energy orchestration platform, which remains its core strategic focus and is expected to serve as the foundation for future revenue generation.

Legacy Technologies

Prior to Grid AI Corp.’s acquisition of AMPX in February 2025, AMPX had developed and operated two principal technology platforms focused on residential and distributed energy management: DLS developed technology and ALICE Home Energy Management Systems (“HEMS”). While Grid Ai Corp. currently supports these technologies, there is very minimal revenue and Grid Ai Corp.’s current focus is on data centers. DLS (Dynamic Load Shaping) is Grid Ai Corp.’s front-of-meter optimization platform designed to manage and optimize large-scale distributed energy resources, such as utility-scale battery energy storage systems and solar arrays, by determining when to charge, hold, or discharge energy based on market and grid conditions. ALICE is Grid AI Corp.’s HEMS platform, which enables residential users to optimize energy usage across devices such as batteries, solar systems, and household appliances through data-driven orchestration.

While historical deployments and trial activity, including in Australia, have not yet resulted in significant commercial revenue, management believes these efforts have provided valuable operational insight and market feedback that inform Grid Ai Corp.’s current strategy. Grid Ai Corp. is actively evaluating lower-friction, near-term commercial opportunities related to these technologies, which may be pursued on a limited, low-cost basis as part of its broader development efforts.

Management has not assumed that all previously contemplated pipeline opportunities related to these legacy platforms will be realized; however, based on current market dynamics and increasing demand for energy optimization solutions, management believes it is reasonable that certain opportunities, including those that may be delayed, could be achieved. Accordingly, management continues to monitor the commercial viability of these platforms and incorporate such assessments into its broader strategic planning and impairment analyses.

Strategic Pivot and Operational Restructuring

Following its acquisition of AMPX, Grid AI Corp. assessed the commercial viability of the above platform offerings, in particular the potential for ALICE. This assessment was informed through discussions with potential customers, investors active in the sector (including venture capital and private equity firms), and executives of adjacent companies and competitors, as well as feedback from trial deployments. Based on this outreach and market feedback, Grid AI Corp.’s management determined that, while customers recognized the technical capabilities of the platform, many were unwilling to replace existing deployed systems that were viewed as sufficiently effective. The Company, together with Grid AI Corp., is currently re-evaluating these opportunities across different geographic markets, including the United States, United Kingdom, and Australia, where market conditions, customer needs, and adoption dynamics may differ from prior deployments.

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Following the above assessment, Grid AI Corp.’s management initiated a strategic pivot in 2025:

●Reduced headcount to lower cash burn

●Scaled back DLS and ALICE to minimum support levels

●Focused on new technology in a fundamentally new market: energy orchestration for hyperscale AI data center campuses

This pivot represents a significant shift in both market focus and technological architecture.

AI Data Center Developed Technology

Following Grid AI Corp’s acquisition of AMPX in February 2025, Grid AI Corp. commenced development of a new technology platform focused on AI-optimized energy orchestration for large-scale data center campuses.

Grid AI Corp. plans to generate revenue from its AI data center platform through:

● Base platform fees for operational visibility and orchestration

● Performance-based fees tied to power cost optimization

The platform is designed to deliver AI-optimized infrastructure by integrating data center operations with advanced energy systems. Core functionality includes data integration across site-level assets (including engines, battery systems, substations, and building systems), real-time monitoring through a centralized “single pane of glass” dashboard, historical data access, and reporting capabilities.

The platform also incorporates a proprietary digital twin model of each site, enabling simulation of energy usage, asset behavior, and grid interactions under various scenarios. This is supported by forecasting models for load, generation, and market conditions, which inform optimization decisions.

Based on Grid AI Corp. management’s experience to date, including discussions with data center operators, energy infrastructure participants, and industry consultants, the Company has not identified a direct competitor offering an equivalent fully integrated solution combining data center orchestration and energy optimization at scale; however, Gris Ai Corp. operates in a broader competitive landscape that includes partial or adjacent solutions.

In addition, the platform includes a co-optimization engine that participates in energy markets (including day-ahead, real-time, and reserve markets, where applicable) while prioritizing uninterrupted data center operations. An orchestration control layer ensures that energy assets operate in accordance with both market commitments and the operational requirements of the data center.

Target customers include enterprise and government entities operating large data center campuses.

Based on current projections:

Gris Ai Corp. markets its legacy technologies and intends to pursue commercial deployment of its AI data center platform through direct sales and strategic partnerships with energy developers, system integrators, engineering firms, and other industry participants. Gris Ai Corp. has commenced early-stage development activities related to its data center orchestration platform in connection with a potential future deployment at a customer site. As of the date of this Current Report on Form 8-K, the platform has not yet been commercially deployed. Initial development and integration activities are ongoing, and any future commercial deployment will depend on the progress of customer projects, including construction and operational readiness milestones, as well as the availability of customer funding.

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Sources and Availability of Raw Materials

Grid AI Corp.’s business is primarily software-based and does not rely on raw materials. Customer deployments may depend on third-party equipment and services, including battery systems, generation assets, and grid infrastructure.

Dependence on Major Customers

Grid AI Corp. is in an early stage of commercialization and expects that a limited number of customers may account for a significant portion of revenue in the near term. Amp Z, which is a related party (see Note 16 within financial statements), is a current customer with whom Grid AI Corp. has been engaged in ongoing collaboration since October 1, 2025; however, as of the date of this report, the parties remain under a letter of intent and have not yet finalized a definitive commercial agreement. Grid AI Corp. has not generated material revenue from Amp Z to date. Accordingly, Grid AI Corp. does not have any major customers at the present time.

Patents, Trademarks, and Agreements

Grid AI Corp. relies on proprietary software, trade secrets, trademarks, and contractual protections. Grid AI Corp. does not currently rely on material labor agreements.

Government Approvals

Grid AI Corp.’s software platform itself generally does not require direct government approvals to operate. However, its solutions are deployed within regulated energy markets and are therefore indirectly subject to a range of federal, state, and local regulatory requirements.

Customer deployments may require regulatory approvals, permits, interconnection agreements, and market participation approvals, which are typically obtained by customers, utilities, or project partners. These approvals may relate to grid interconnection, participation in wholesale electricity markets, local permitting, and compliance with applicable energy regulations.

Grid AI Corp.’s platform is designed to operate within complex and evolving regulatory frameworks, including those governing distributed energy resources, virtual power plants, and wholesale market participation. Changes in laws, regulations, market rules, or regulatory interpretations could impact the ability of customers to deploy Grid AI Corp.’ solutions, participate in energy markets, or realize the expected economic benefits of the platform.

In addition, Grid AI Corp. relies on integrations with third-party systems and market operators, including utilities, grid operators, and energy market platforms, which are themselves subject to regulatory oversight. Delays in obtaining required approvals, changes in regulatory requirements, or limitations imposed by regulators or market operators could adversely affect Grid AI Corp.’s business, operating results, and financial condition.

Effect of Government Regulation

Grid AI Corp. operates in regulated energy markets. Regulatory changes affecting energy storage, distributed energy resources, interconnection, or energy markets could impact its business.

Environmental Compliance

Grid AI Corp.’s operations are primarily software-based and are not expected to incur material environmental compliance costs. Customer projects may be subject to environmental regulations that could affect project timing.

Our Legacy Biopharmaceutical Activities

As of December 31, 2025, our legacy biopharmaceutical activities are centered on Adrulipase, our recombinant lipase enzyme program for the treatment of exocrine pancreatic insufficiency, or EPI. We are no longer developing the Latiglutenase, CypCel, Capeserod or Niclosamide programs. Following the closing of the rescission transaction involving ImmunogenX, LLC on December 31, 2025, the Latiglutenase and CypCel programs are no longer part of our business. We also terminated our license agreement with Sanofi relating to Capeserod in February 2025, and we are no longer actively pursuing Niclosamide.

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Our Adrulipase program is focused on the development of an oral, non-systemic biologic therapy for the treatment of EPI in patients with cystic fibrosis, or CF, and chronic pancreatitis, or CP. Our goal is to provide CF and CP patients with a therapy to control EPI that is non-animal derived and offers the potential to dramatically reduce their daily pill burden. CP, the most common cause of EPI, is a long-standing inflammation of the pancreas that alters its normal structure and functions. In the U.S., its prevalence rate is 42 cases per 100,000 inhabitants, resulting in approximately 132,000 cases. Approximately 60% of patients affected with CP display EPI, resulting in approximately 90,000 patients requiring substitution therapy in the U.S. In Western societies, CP is caused by chronic alcoholic consumption in approximately 55-80% of cases. Other relatively frequent etiologies include the genetic form of the disease that is inherited as an autosomal dominant condition with variable penetrance, pancreatic trauma and idiopathic causes.

CF, another dominant etiology of EPI, is a severe genetic disease associated with chronic morbidity and life-span decrease of most affected individuals. In most Caucasian populations, CF prevalence is of 7-8 cases per 100,000 inhabitants, but is less common in other populations, resulting in more than 30,000 affected individuals in the U.S. and more than 70,000 affected individuals worldwide. CF is inherited as monogenic autosomal recessive disease due to the defect at a single gene locus that encodes the Cystic Fibrosis Transmembrane Regulator protein, or CFTR, a regulated chloride channel. Mutation of both alleles of this chloride channel gene results in the production of thick mucus, which causes a multisystem disease of the upper and lower respiratory tracts, digestive system, and the reproductive tract. The progressive destruction of the pancreas results in EPI that is responsible for malnutrition and contributes to significant morbidity and mortality. About 80-90% of patients with CF develop EPI, resulting in approximately 25,000-27,000 patients in the U.S. that require substitution therapy.

In July 2023, we announced topline results from our Phase 2b pilot monotherapy bridging study using a new enteric microgranule formulation of Adrulipase. Although the primary efficacy endpoint was not achieved, we believe that this may be on account of issues with quality control and clinical approach related to the study. Data from the study indicated that the enhanced Adrulipase formulation was well tolerated and demonstrated an improvement over prior formulations of Adrulipase, and there was an improvement in the CFA to therapeutic levels in cystic fibrosis patients with exocrine pancreatic insufficiency. We plan to have a meeting with the FDA to discuss the next steps in this regard. We are currently evaluating next steps for the Adrulipase program, including potential future clinical development, subject to available capital.

Adrulipase

Adrulipase is the active pharmaceutical ingredient derived from Yarrowia lipolytica, an aerobic yeast naturally found in various foods such as cheese and olive oil that is widely used as a biocatalyst in several industrial processes. Adrulipase is a secreted lipase naturally produced by Yarrowia lipolytica, known as LIP2, that we are developing through recombinant DNA technology for the treatment of EPI associated with CF and CP. Lipases are enzymes that help with the digestion of lipids and fats.

We previously held the exclusive right to commercialize Adrulipase in the United States, Canada, South America (excluding Brazil), Asia (excluding China, Hong Kong, and Japan), Australia, New Zealand and Israel pursuant to a sublicense from Laboratories Mayoly Spindler SAS, or Mayoly, under the Joint Research and Development Agreement, or JDLA, which also granted us joint commercialization rights for Brazil, Italy, China and Japan. In March 2019, we purchased all rights, title and interest in and to Adrulipase from Mayoly pursuant to the Mayoly Asset Purchase Agreement, or APA, although Mayoly retained exclusive commercial rights in France and Russia.

Background

The pancreas is both an endocrine gland that produces important hormones, including insulin, glucagon and pancreatic polypeptide, and a digestive organ that secretes pancreatic juice containing digestive enzymes that assist with nutrient absorption and digestion in the small intestine.

The targeted indication for Adrulipase is the treatment of EPI, which occurs when the exocrine functions of the pancreas are reduced to below approximately 10% of normal. The symptoms of EPI are driven primarily by pancreatic lipase deficiency, which results in impaired digestion of fats and other nutrients. Lipid maldigestion due to lipase deficiency can lead to weight loss, steatorrhea, greasy diarrhea and fat-soluble vitamin deficiencies.

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CP is one of the principal causes of EPI. CF is another major etiology of EPI and is a severe genetic disease associated with chronic morbidity and reduced life expectancy. A substantial percentage of CF patients develop EPI and require enzyme substitution therapy.

Current treatments for EPI in CP and CF rely primarily on porcine pancreatic enzyme replacement therapies, or PERTs. Although PERTs are a long-established standard of care, they have limitations, including high pill burden, formulation challenges, variability associated with animal-derived sourcing and limited effectiveness in certain patients. Adrulipase is intended to address EPI using a recombinant, non-porcine lipase approach. Management believes that this non-animal derived profile remains a meaningful differentiating feature of the program.

Pre-Clinical Program

The efficacy of Adrulipase has been investigated in normal minipigs, which are generally considered a relevant model for digestive drug development because of physiological similarities to humans and their omnivorous diet. Experimental pancreatitis was induced by pancreatic duct ligation, resulting in severe EPI with baseline coefficient of fat absorption, or CFA, around 60% post-ligature. CFA is a measurement obtained by quantifying the amount of fat ingested orally over a defined time period and subtracting the amount eliminated in stool to estimate the amount absorbed by the body.

At doses ranging from 10.5 mg to 211 mg, Adrulipase increased CFA by approximately 25% to 29% compared to baseline, while lower doses showed more limited activity. Similar efficacy was observed in pigs receiving enteric-coated porcine pancreatic extract. These findings demonstrated in vivo activity of Adrulipase in a relevant model.

Two non-clinical toxicology studies have been conducted to date. Based on those studies, Adrulipase appeared to be well tolerated at clinically relevant dose levels in both rodent and non-rodent species.

Clinical Program

We have historically evaluated Adrulipase for two principal therapeutic settings: (i) children and adults affected by CF and (ii) adult patients with CP. In recent periods, our primary focus has been on the CF-related EPI opportunity.

Chronic Pancreatitis

During 2010 and 2011, a Phase 1/2a clinical trial of Adrulipase was conducted in conjunction with Mayoly at a single center in France. The study was primarily designed to investigate safety in 12 patients with CP or pancreatectomy and severe EPI. Adrulipase was generally well tolerated, with no serious adverse events reported. Although efficacy findings were limited and not statistically significant, the study was not designed to demonstrate statistically significant changes in CFA or steatorrhea.

We later received regulatory approvals in Australia, New Zealand and France to conduct a Phase 2 multi-center dose escalation study of Adrulipase in CP and pancreatectomy patients. In September 2018, we announced that, in pre-planned analyses, both the study’s primary and secondary endpoints were achieved, including a statistically significant improvement in CFA in a per-protocol analysis at the highest evaluated dose.

Cystic Fibrosis Monotherapy

In October 2018, the FDA cleared our IND application for Adrulipase in patients with EPI due to CF. We then initiated the Phase 2 OPTION Bridging Dose Study to investigate the safety, tolerability and efficacy of Adrulipase in CF patients with EPI compared against standard PERT therapy.

In September 2019, we announced positive results from the OPTION Bridging Dose Study. Although the study was not powered for statistical significance, the data showed meaningful signs of activity, including CFAs in a portion of patients that approached levels required for non-inferiority with standard PERTs. The coefficient of nitrogen absorption, or CNA, was also comparable between Adrulipase and PERT arms, which management considered important because it suggested protease supplementation might not be required with Adrulipase treatment.

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The subsequent OPTION 2 Trial was designed to investigate the safety, tolerability and efficacy of Adrulipase in enteric capsules, at two dose levels, compared head-to-head against PERT. In March 2021, we announced topline OPTION 2 data. The trial demonstrated that Adrulipase was safe and well tolerated and that prior clinical work had shown evidence of drug activity. However, OPTION 2 did not consistently meet the primary efficacy endpoint. Some patients achieved CFA levels supportive of non-inferiority to PERT, but the overall efficacy results were uneven. Management believed that the enteric capsule formulation likely contributed to these results because the formulation appeared to dissolve too slowly in the small intestine to release the lipase in time to optimize digestion.

In response, we began development of a new enteric microgranule formulation of Adrulipase, designed to provide improved delivery characteristics. Following FDA review of the applicable IND amendment, we initiated a Phase 2b pilot monotherapy study during 2023 and received topline data in the third quarter of 2023. Although the primary efficacy endpoint was not achieved, the data indicated that the enhanced Adrulipase formulation was safe, well tolerated and improved over prior formulations. Management’s later internal assessment concluded that the program’s scientific rationale remained intact, although the path forward became narrower and more execution-dependent following these results.

As of December 31, 2025, Adrulipase remained our principal retained biopharmaceutical program. No clinical trials were conducted during 2025 as the Company focused on preserving liquidity and restructuring operations. Management has continued to evaluate potential next steps for the program, including future regulatory dialogue and clinical-development options. However, the timing and scope of any further development will depend on available capital, strategic priorities and additional assessment of the clinical and commercial path forward.

Combination Therapy

We also evaluated Adrulipase in combination with PERT in CF patients suffering from severe EPI who continued to experience fat malabsorption symptoms despite taking the maximum daily dose of PERTs. The Combination Trial was designed to investigate escalating doses of Adrulipase used together with a stable dose of PERTs in order to improve CFA and relieve abdominal symptoms.

We previously announced positive interim and topline data from this study indicating clinically meaningful improvements in CFA and other secondary measures, including stool characteristics and weight-related observations. Based on these results and later internal review, management believes that the most credible remaining value proposition for Adrulipase may include an adjunct-therapy or treatment-burden reduction thesis, rather than solely a full monotherapy replacement strategy. While no assurance can be given that this approach will ultimately succeed, management believes the available data support the conclusion that Adrulipase retained a plausible development pathway as of December 31, 2025.

Recent Developments

Nasdaq Listing and Compliance Matters

On April 22, 2026, the Company received a notice (the “Notice”) from The Nasdaq Stock Market LLC (“Nasdaq”) indicating that the Company is not in compliance with Nasdaq Listing Rule 5250(c)(1) as a result of its failure to timely file its Annual Report on Form 10-K for the period ended December 31, 2025. The Notice provides that the Company has 60 calendar days to submit a plan to regain compliance. If Nasdaq accepts the Company’s plan, Nasdaq may grant an exception of up to 180 calendar days from the filing’s due date, or until October 12, 2026, for the Company to regain compliance.

The Company intends to submit a plan to regain compliance within the required timeframe; however, there can be no assurance that Nasdaq will accept the Company’s plan or that the Company will be able to regain compliance within any extension period that may be granted.

During 2025, we were subject to multiple Nasdaq compliance matters.

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Annual Meeting Requirement

On January 7, 2025, we received notice from Nasdaq that we were not in compliance with Nasdaq Listing Rule 5620(a) because we had not held an annual meeting of stockholders in 2024 within the required time period. We submitted a compliance plan, and Nasdaq granted us an extension until June 30, 2025 to regain compliance. Following the filing of our proxy statement on June 4, 2025 and the holding of our annual meeting of stockholders on June 30, 2025, Nasdaq notified us on July 3, 2025 that this matter was closed.

Minimum Bid Price Requirement

On September 6, 2024, we received notice from Nasdaq that we were not in compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2). On March 6, 2025, Nasdaq granted us an additional 180-day compliance period, or until September 1, 2025, to regain compliance. During 2025, we effected a 1-for-3 reverse stock split, which became effective on August 18, 2025. On September 3, 2025, Nasdaq notified us that, because the closing bid price of our Common Stock had been at least $1.00 per share for 10 consecutive business days from August 18, 2025 through September 2, 2025, we had regained compliance with Listing Rule 5550(a)(2), and this matter was closed.

Minimum Stockholders’ Equity Requirement

On April 11, 2025, Nasdaq notified us that we were not in compliance with the minimum stockholders’ equity requirement under Nasdaq Listing Rule 5550(b)(1), based on stockholders’ deficit of $(3,876,738) as reported in our Annual Report on Form 10-K for the year ended December 31, 2024. Nasdaq also noted that, as of April 10, 2025, we did not satisfy the alternative continued-listing standards based on market value of listed securities or net income from continuing operations. We submitted a compliance plan, and on June 25, 2025 Nasdaq granted us an extension until October 8, 2025 to regain compliance, subject to specified terms. On October 28, 2025, Nasdaq notified us that, based on our Form 8-K dated October 6, 2025, it had determined that we complied with Listing Rule 5550(b)(1). Nasdaq also stated that if we failed to evidence compliance upon filing our next periodic report, we could again be subject to delisting.

GridAI Transaction and Nasdaq Change of Control Determination

On November 5, 2025, Nasdaq notified us that our proposed transaction with GridAI Corp. constituted a business combination resulting in a “Change of Control” under Nasdaq Listing Rule 5110(a). Nasdaq stated that the post-transaction entity would be required to satisfy all of Nasdaq’s initial listing criteria and complete Nasdaq’s initial listing process, including payment of applicable fees, prior to shareholder approval for the second step of the transaction. Nasdaq further stated that if shareholder approval were obtained for the second step and the post-transaction company failed to qualify for listing or timely complete the initial listing process, Nasdaq would issue a Staff Delisting Determination and commence delisting proceedings. As of the date of this Annual Report, the Company has not received a Staff Delisting Determination from Nasdaq in connection with the transaction and continues to be listed on the Nasdaq Capital Market.

Acquisition of GridAI Corp. and Corporate Rebranding

On September 30, 2025, we completed a share exchange transaction pursuant to which we acquired 100% of the outstanding equity interests of Grid AI Corp. In the transaction, we issued 424,348 shares of our Common Stock and 38,801.546 shares of our Series H Non-Voting Convertible Preferred Stock to the sellers of Grid AI Corp. At the time of closing, Grid AI Corp. owned 75% of the outstanding equity interests of AMPX, which holds the operating subsidiary AMPX Limited. Following the acquisition, Grid AI Corp. and its subsidiaries became consolidated subsidiaries of the Company.

Effective December 1, 2025, we changed our corporate name from Entero Therapeutics, Inc. to GridAI Technologies Corp. and changed our Nasdaq trading symbol from “ENTO” to “GRDX.”

Management and Governance Changes

During the fourth quarter of 2025, we experienced significant management and board changes in connection with the transition of the Company following the Grid AI Corp. acquisition. Effective in December 2025, Jason Sawyer became our Chief Executive Officer.

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Also during December 2025, certain directors resigned, including one resignation accompanied by stated disagreements regarding governance, diligence and disclosure matters, as disclosed in our Current Report on Form 8-K filed with the SEC on December 4, 2025.

Corporate History

We were incorporated on January 30, 2014 in the State of Delaware under the name AzurRx BioPharma, Inc. In May 2014, we entered into a stock purchase agreement with Protea Biosciences Group, Inc. and its wholly owned subsidiary, Protea Biosciences, Inc., to acquire 100% of the outstanding capital stock of AzurRx SAS, formerly ProteaBio Europe SAS, a wholly owned subsidiary of Protea Biosciences, Inc. The acquisition was completed in June 2014. In October 2016, we completed our initial public offering and listed our Common Stock on the Nasdaq Capital Market.

On September 13, 2021, we completed the acquisition of First Wave Bio, Inc., which became our wholly owned subsidiary. In connection with that acquisition, AzurRx BioPharma, Inc. changed its name to First Wave BioPharma, Inc.

Effective October 26, 2022, our AzurRx SAS subsidiary was dissolved.

On March 13, 2024, we completed our merger with ImmunogenX, Inc. Following the merger, ImmunogenX became part of our corporate structure through ImmunogenX, LLC, a Delaware limited liability company and wholly owned subsidiary of the Company. In May 2024, we changed our name from First Wave BioPharma, Inc. to Entero Therapeutics, Inc.

On March 24, 2025, we entered into a Rescission Agreement with ImmunogenX, LLC and the former shareholders of ImmunogenX, Inc. The rescission transaction was completed on December 31, 2025. Following the closing of that transaction, ImmunogenX, LLC ceased to be a subsidiary of the Company, and we no longer held any ownership interest in that business.

On September 30, 2025, we completed a share exchange transaction pursuant to which we acquired 100% of the outstanding equity interests of Grid AI Corp., a Nevada corporation. At the time of the acquisition, Grid AI Corp. owned 75% of the issued and outstanding equity interests of AMPX, which holds the operating subsidiary AMPX Limited. Following the transaction, GridAI Corp. and its subsidiaries became consolidated subsidiaries of the Company.

Effective December 1, 2025, we changed our corporate name from Entero Therapeutics, Inc. to GridAI Technologies Corp. In connection with this name change, our Nasdaq trading symbol changed from “ENTO” to “GRDX.”

Intellectual Property

Our goal is to obtain, maintain and enforce intellectual property protection for our technologies, product candidates, formulations, processes, methods, software, trade names and other proprietary assets, preserve our trade secrets, and operate without infringing the proprietary rights of third parties in the United States and foreign jurisdictions. Our policy is to seek, where appropriate, the broadest intellectual property protection reasonably available for our current and future technologies through a combination of patents, trade secrets, know-how protection, confidentiality and invention-assignment agreements, trademarks, copyrights and contractual arrangements. However, patent protection may not provide complete protection against competitors that seek to design around or otherwise circumvent our patents, and our proprietary rights may not always provide us with meaningful competitive advantages.

We also depend on the skills, knowledge, experience and know-how of our management, engineering, research and development personnel, as well as our advisors, consultants and contractors. To help protect proprietary know-how that may not be patentable, or for inventions that may be difficult to enforce through patents alone, we rely on trade secret protection and confidentiality arrangements. We require our employees, consultants, advisors and other contractors to enter into confidentiality agreements that prohibit the unauthorized disclosure of confidential information and, where applicable, require disclosure and assignment to us of ideas, developments, discoveries and inventions important to our business.

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As of December 31, 2025, our principal retained legacy life sciences intellectual property relates to Adrulipase. We are no longer actively developing the Latiglutenase, CypCel, Capeserod or Niclosamide programs, and following the completion of the rescission transaction involving ImmunogenX, LLC on December 31, 2025, the Latiglutenase and CypCel intellectual property is no longer part of our business. We also terminated the Sanofi license relating to Capeserod in 2025 and are no longer actively pursuing the Niclosamide program.

Adrulipase

The Adrulipase program is protected by a patent portfolio that we originally licensed under the Mayoly arrangements and subsequently acquired.

This portfolio includes the PCT/FR2006/001352 patent family, including European Patent EP2035556 and U.S. Patents 8,334,130 and 8,834,867, entitled “Method for producing lipase, transformed Yarrowia lipolytica cell capable of producing said lipase and their uses.” These patents describe a method for producing Yarrowia lipolytica acid-resistant recombinant lipase using a culture medium without products of animal origin or non-characterized mixtures such as tryptone, peptone or lactoserum, as well as related uses. The European patents expire on June 15, 2026, U.S. Patent 8,334,130 expires on September 11, 2028, and U.S. Patent 8,834,867 expires on July 17, 2026.

In addition, an international PCT application directed to our proprietary Adrulipase formulation was filed in 2021 and was subsequently filed in the United States and certain foreign jurisdictions. Any patents issuing from these filings are expected to expire in 2041.

Additional international PCT applications were filed in 2022 and nationalized in certain jurisdictions outside the United States relating to stable lipase formulations and methods of treatment. Any patents issuing from these filings are expected to expire in 2042. These applications are not pending in the United States.

An additional PCT international application directed to Adrulipase formulations was filed in 2023. Any patents issuing from this filing are expected to expire in 2043.

We also believe Adrulipase may be eligible, if approved and if the applicable statutory requirements are met, for regulatory exclusivity, including potential biologic exclusivity in the United States and data exclusivity in certain foreign jurisdictions. The availability, scope and duration of any such exclusivity would depend on the final regulatory pathway, product classification, approved indication and applicable law at the time of approval.

Grid AI and AMPX

Following our acquisition of Grid AI Corp. on September 30, 2025, our intellectual property portfolio also includes proprietary software, trade secrets, trademarks, and contractual protections associated with the Grid AI Corp. and AMPX energy orchestration platform. In our acquisition accounting, we recognized identifiable intangible assets that included developed technology and trade name rights associated with the acquired business. We believe the principal protectable value of this business resides in developed software, algorithms, platform architecture, implementation know-how, copyrights, trade secrets, brands and contractual rights.

We seek to protect the Grid AI Corp. and AMPX business through a combination of proprietary software ownership, trade secret protection, confidentiality and invention-assignment agreements, copyrights, trade names and contractual arrangements with employees, contractors, customers and partners.

Grid AI Corp. and AMPX offerings depend in part on integration with third-party systems, data feeds, devices, utilities, market operators and software interfaces. As a result, the practical protection and commercial utility of this part of our intellectual property portfolio depends not only on code ownership and trade secret protection, but also on maintaining contractual rights, technical interoperability and commercially reasonable access to relevant third-party ecosystems. If those relationships are disrupted, modified on unfavorable terms or replaced by proprietary ecosystems we cannot access, portions of our services, functionality or market position could be adversely affected.

We may also use open-source software components in portions of our technology stack. Use of open-source software can impose obligations that could require us to make source code available, limit certain licensing strategies, or expose us to cybersecurity

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and compliance risks. We maintain policies and procedures intended to manage such use, but we cannot assure compliance under all circumstances.

Discontinued and Divested Legacy Programs

Prior to the completion of the rescission transaction involving ImmunogenX, our business included the Latiglutenase and CypCel programs, and prior to 2025 we also held intellectual property relating to Niclosamide-based development programs and licensed rights relating to Capeserod. As of December 31, 2025, those programs are no longer part of our active development portfolio, and, in the case of ImmunogenX, are no longer part of our business. Accordingly, we do not view those intellectual property assets as part of our principal continuing operating platform.

Manufacturing

We do not currently operate our own manufacturing facilities. Instead, we rely on a combination of contract development and manufacturing organizations (“CDMOs”), third-party component suppliers and technology partners to support our product development and platform deployment activities. We expect to continue to rely on third-party manufacturers, software infrastructure providers and integration partners for the foreseeable future.

Adrulipase

Historically, the Adrulipase active pharmaceutical ingredient (“API”), including both drug substance and drug product, has been manufactured by Asymchem, Inc. at a contract manufacturing facility located in Tianjin, China. Charles River Laboratories, based in Malvern, Pennsylvania, has been responsible for maintaining our master and working cell banks used in the Adrulipase manufacturing process.

As of December 31, 2025, no active clinical trials of Adrulipase were being conducted. We believe that multiple contract manufacturers may be capable of producing Adrulipase drug substance and drug product for future clinical development if the program is advanced. We anticipate that, if the program is advanced, manufacturing activities would not commence until later in 2026. However, biopharmaceutical manufacturing processes can be complex, and there can be no assurance that manufacturing processes can be readily reproduced or transferred to alternative manufacturers without additional development work, validation activities or regulatory review.

Grid AI Corp. and AMPX Platform

Following our acquisition of Grid AI Corp., our manufacturing and deployment activities also include the production, integration and installation of energy orchestration systems associated with the AMPX platform.

The AMPX platform is primarily a software-driven energy orchestration and control system that integrates with third-party energy infrastructure, including distributed energy resources, electric vehicle charging systems, batteries, HVAC systems, water heaters, solar systems and other connected devices. As a result, our business model relies significantly on software deployment, system integration and third-party hardware ecosystems rather than traditional manufacturing.

Where hardware components are required for deployment, including control devices, gateways, communications modules or integration hardware, these components are generally sourced from third-party suppliers and integrated into our platform environment. Our operations depend on the availability, quality and performance of these third-party hardware and software components, as well as the reliability of communications networks and cloud infrastructure used to operate the platform.

Because our energy orchestration services depend on integration with devices, utilities, aggregators and market operators, we rely on a network of integration partners, installers, device manufacturers and software providers to support the deployment and operation of the AMPX platform. Disruptions in the supply of compatible devices, integration partners or cloud infrastructure could adversely affect the deployment, scalability or performance of our platform.

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Competition

Grid AI Corp. operates in a competitive and rapidly evolving market that includes energy management software providers, virtual power plant (“VPP”) platforms, battery system integrators, utilities, engineering firms, and in-house customer-developed solutions. Grid AI Corp. also competes with emerging technology providers focused on distributed energy resource optimization and artificial intelligence-driven grid management.

Competition is driven by several factors, including software functionality, scalability, interoperability with third-party hardware and market platforms, speed of deployment, regulatory expertise, customer relationships, and pricing. The Company’s solutions must integrate with a wide range of third-party systems, including batteries, control systems, and energy market infrastructure, which are often not standardized and may change over time.

The markets in which Grid AI Corp. operates are highly competitive and include both established industry participants with significant financial, technical, and commercial resources, as well as new entrants seeking to capitalize on the growth of distributed energy and AI-driven energy optimization. Some competitors offer vertically integrated solutions, including hardware, software, and energy services, while others provide point solutions that compete with specific components of Grid AI Corp.’s platform.

Grid AI Corp.’s ability to compete successfully depends on its ability to continue to innovate, expand its platform capabilities, maintain reliable system performance, and effectively execute its go-to-market strategy. Grid AI Corp. also competes based on its ability to convert pilot programs and non-binding arrangements into long-term commercial contracts, scale deployments across multiple jurisdictions, and adapt to evolving regulatory frameworks and market rules.

In addition, customers may elect to develop in-house energy management systems or partner with alternative providers, which may reduce demand for the Company’s solutions. As a result, Grid AI Corp. may face pricing pressure, longer sales cycles, and increased customer acquisition costs. If Grid AI Corp. is unable to compete effectively, it may lose market share, which could adversely affect its business, operating results, and financial condition.

Adrulipase

With respect to Adrulipase, if approved, we would compete with pancreatic enzyme replacement therapies (“PERTs”), which represent the current standard of care for the treatment of exocrine pancreatic insufficiency (“EPI”). The PERT market is dominated by a small number of established pharmaceutical products marketed by larger companies, including:

● CREON® marketed by AbbVie Inc.

● ZENPEP® marketed by Nestlé Health Science

● PANCREAZE® marketed by VIVUS, Inc.

● PERTZYE® marketed by Chiesi Farmaceutici S.p.A.

Several PERT products have been approved by the U.S. Food and Drug Administration for sale in the United States and have been used in clinical practice for many years.

If Adrulipase were successfully developed and approved, we believe competition in this market would depend on several factors, including the ability to demonstrate clinical efficacy and safety relative to existing therapies, regulatory approval, pricing and reimbursement considerations and acceptance by physicians, patients and healthcare payors.

Adrulipase differs from currently available PERT therapies in that it is designed as a recombinant, non-animal derived enzyme. As a result, the product may potentially address certain limitations associated with porcine-derived pancreatic enzyme therapies, including pill burden and sourcing considerations. However, we cannot assure that Adrulipase will ultimately demonstrate advantages over existing therapies or achieve regulatory approval or commercial adoption.

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Government Regulation and Product Approval

Our businesses are subject to extensive regulation in the United States and in foreign jurisdictions. Following our acquisition of Grid AI Corp. on September 30, 2025, our regulatory environment now includes both (i) pharmaceutical and biotechnology regulation applicable to our legacy Adrulipase program and related life sciences activities and (ii) regulatory, compliance, privacy, cybersecurity, contractual and market-participation requirements applicable to our Grid AI Corp. and AMPX energy orchestration platform. Failure to comply with applicable laws and regulations could result in delays, penalties, contractual claims, restrictions on operations, loss of market access or other adverse consequences.

Energy Technology, Software and Grid Services Regulation

Our GridAI business operates in a regulatory environment that includes federal, state and local energy market rules, data privacy and cybersecurity requirements, and contractual and interconnection standards applicable to distributed energy resources and grid-connected systems. Our legacy AmpX energy orchestration platform enables participation in wholesale and retail electricity markets and is subject to oversight by entities such as the Federal Energy Regulatory Commission, regional transmission organizations and independent system operators, as well as applicable state public utility commissions.

Participation in these markets requires compliance with market rules governing bidding, dispatch, settlement, telemetry, and performance obligations. In addition, our platform and operations are subject to interconnection requirements, utility tariffs, and, where applicable, certification or registration requirements for market participants or service providers.

Our business is also subject to evolving data privacy, cybersecurity and critical infrastructure protection standards, including requirements related to the protection of customer data and grid reliability. These may include compliance with applicable standards established by NERC (the North American Electric Reliability Corporation), as well as federal and state data protection laws.

Failure to comply with applicable regulatory, market or contractual requirements could result in financial penalties, limitations on market participation, termination of customer or utility agreements, or other adverse operational impacts. The regulatory framework governing distributed energy resources, virtual power plants and grid orchestration technologies is rapidly evolving, and changes in laws, regulations or market rules could impact our business model, costs and growth opportunities.

Biopharmaceutical Regulation

Government authorities in the United States, at the federal, state and local levels, and in other countries, extensively regulate, among other things, the research, development, testing, manufacture, quality control, approval, labeling, packaging, storage, recordkeeping, promotion, advertising, distribution, post-approval monitoring and reporting, marketing and import and export of pharmaceutical and biologic products such as Adrulipase. To date, our internal legacy research and development efforts have historically involved activities in Europe and North America, and we expect that any future clinical development of Adrulipase, if pursued, would likely involve the United States and potentially Europe, subject to available capital, strategic priorities and regulatory alignment.

In the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, or FDCA, and its implementing regulations, and regulates biologics under the FDCA, the Public Health Service Act, or PHSA, and their implementing regulations. FDA approval is required before any new unapproved drug or biologic may be marketed in the United States. Pharmaceutical and biologic products are also subject to other federal, state and local statutes and regulations. If we fail to comply with applicable FDA or other requirements at any point during development, testing, review, approval or after approval, we may become subject to administrative or judicial sanctions, including warning letters, license suspension or revocation, product recalls, seizures, injunctions, fines, civil penalties or criminal prosecution.

The process required by the FDA before a product candidate may be marketed in the United States generally involves:

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● FDA acceptance of the NDA or BLA for filing and substantive review

An IND is a request for authorization from the FDA to administer an investigational product to humans. It includes, among other things, the proposed clinical protocol or protocols, toxicology and pharmacology data, chemistry, manufacturing and controls information and any available prior human data. Unless the FDA raises concerns within 30 days after receipt, the IND becomes effective and clinical trials may begin. However, the FDA may impose a clinical hold at any time if it identifies safety, scientific, manufacturing or other concerns.

Clinical Trials

Clinical trials involve the administration of an investigational product to human subjects under the supervision of qualified investigators in accordance with good clinical practice, or GCP, requirements. These include the requirement that all subjects provide informed consent before participating in a study. Clinical trials must be conducted under protocols that describe the study objectives, design, methodology, statistical considerations and other requirements. Protocols and protocol amendments are submitted to the FDA as part of the IND, and IRB approval must be obtained for each site before enrollment begins.

Clinical development generally proceeds through Phase 1, Phase 2 and Phase 3 studies, although these phases may overlap or be combined in some cases. The FDA may also require or request post-approval, or Phase 4, studies.

As of December 31, 2025, we were not conducting active clinical trials for Adrulipase. Any future advancement of Adrulipase would require additional funding, updated clinical and regulatory planning and continued compliance with applicable FDA and other regulatory requirements. There can be no assurance that we will resume development of Adrulipase on any particular timetable or at all.

Chemistry, Manufacturing and Controls

Companies seeking FDA approval must also provide information regarding the composition, manufacture, stability and quality controls of a product candidate. The manufacturing process must be capable of consistently producing product in accordance with current good manufacturing practice, or cGMP, requirements. Sponsors must develop and validate methods for testing identity, strength, quality, potency and purity and must demonstrate acceptable stability over the proposed shelf life.

Before approving an NDA or BLA, the FDA typically inspects the facility or facilities where the product is manufactured. FDA approval may be withheld if the manufacturing processes or facilities are not in compliance with cGMP or are otherwise deemed inadequate.

FDA Review of NDA or BLA

Once an NDA or BLA is submitted, the FDA conducts a preliminary review to determine whether the application is sufficiently complete for substantive review. The FDA may issue an approval letter or a complete response letter. A complete response letter indicates that the review is complete but the application is not ready for approval in its present form. Such a letter may require additional clinical data, manufacturing information, inspections, analyses or other information, and it can result in significant delays and added

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expense. Even if additional information is submitted, the FDA may still determine that the application does not satisfy the standards for approval.

The FDA may also require a risk evaluation and mitigation strategy, or REMS, post-marketing studies, labeling changes, additional controls or other conditions of approval. If compliance with regulatory requirements is not maintained after approval, the FDA may impose restrictions, require recalls, suspend or withdraw approval or pursue other enforcement action.

Expedited Programs and Exclusivity

The FDA maintains programs designed to facilitate or expedite the development and review of products intended to treat serious or life-threatening diseases or conditions and to address unmet medical needs. These include fast track designation, breakthrough therapy designation, accelerated approval, priority review and, for qualifying products, regenerative medicine advanced therapy, or RMAT, designation.

Even if a product is eligible for one or more expedited programs, the FDA may later determine that the product no longer qualifies for such program or that expedited review does not shorten the development or review process in practice.

Adrulipase may also, if approved and if applicable legal requirements are satisfied, potentially benefit from regulatory exclusivity, including orphan drug exclusivity or biologic exclusivity. However, the scope, availability and duration of any such exclusivity would depend on the approved product, indication, application pathway and applicable law at the time of approval.

Post-Approval Requirements

Any approved pharmaceutical or biologic product would remain subject to continuing FDA and other regulatory oversight, including requirements for adverse event reporting, manufacturing controls, labeling, advertising and promotion, recordkeeping, periodic reporting, sampling and distribution. Manufacturing establishments are also subject to periodic inspections. Later discovery of previously unknown problems, adverse events, manufacturing deficiencies or other regulatory noncompliance could result in restrictions on the product or the manufacturer, labeling changes, additional post-marketing requirements, recalls, fines, warning letters, withdrawal of approval or other enforcement action.

The FDA also strictly regulates promotion. Promotional claims may generally be made only for approved indications and in a manner consistent with approved labeling. Improper promotion of off-label uses may subject a company to significant liability.

Other Healthcare Laws and Compliance Requirements

Our legacy life sciences business is also subject to healthcare fraud and abuse laws, false claims laws, privacy and security laws, physician payment transparency laws and similar requirements in the United States and abroad. These may include, among others, the federal Anti-Kickback Statute, the federal False Claims Act, HIPAA, state data privacy laws and state or federal sunshine laws. Violations may result in civil or criminal penalties, damages, fines, exclusion from government healthcare programs, integrity obligations and reputational harm.

Coverage and Reimbursement

Sales of any pharmaceutical or biologic product, if approved, depend in part on the extent to which such product is covered by third-party payors, including federal and state healthcare programs, private insurers and managed care organizations, and the level of reimbursement available for the product. Coverage and reimbursement decisions are made on a payor-by-payor basis, and many payors are seeking to control costs by reducing reimbursement levels, narrowing formularies or imposing other utilization controls. Legislative and regulatory changes affecting pricing, rebates and reimbursement may also adversely affect the commercial opportunity for any approved product.

Healthcare Reform and Other Legislative Changes

The healthcare industry is subject to continuing legislative and regulatory change. U.S. federal and state governments and foreign governments continue to adopt and consider measures intended to reduce healthcare costs, increase pricing transparency, expand the use of generics and biosimilars and otherwise affect the pricing, reimbursement and commercialization of pharmaceuticals. Such

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changes could reduce the commercial potential of any pharmaceutical product we may successfully develop and obtain approval for in the future.

Foreign Corrupt Practices Act and Similar Laws

Our business activities may be subject to the U.S. Foreign Corrupt Practices Act, or FCPA, and similar anti-bribery and anti-corruption laws in other jurisdictions. The FCPA generally prohibits offering, promising, giving or authorizing anything of value, directly or indirectly, to a foreign official for the purpose of obtaining or retaining business or securing an improper advantage. It also requires public companies to maintain accurate books and records and adequate internal accounting controls. Because our operations may involve interactions with foreign officials, public utilities, public healthcare systems, customs authorities and other governmental actors, any failure by us or our agents, contractors, suppliers, collaborators or business partners to comply with these laws could result in substantial penalties and other adverse consequences.

Energy Technology, Grid Services and Data Regulation

Following our acquisition of Grid AI Corp., our business is also subject to legal and regulatory requirements applicable to software-enabled energy orchestration, distributed energy resources, virtual power plant participation, demand response activity, data handling, cybersecurity and interactions with utilities, market operators, aggregators and device ecosystems.

Our Grid AI and AMPX operations may be affected by, among other things:

● utility rules and tariffs

● grid interconnection and market participation requirements

● electrical, communications, device integration and installation standards

● software, cloud, cybersecurity and critical infrastructure requirements

● data privacy, data security and consumer protection laws

In addition, because our platform may integrate with third-party devices, data feeds, utility systems, cloud infrastructure and market systems, our ability to deploy and scale offerings may depend on continued access to such systems and compliance with contractual and technical requirements imposed by third parties. Regulatory changes affecting demand response, virtual power plants, distributed energy resources, energy market participation, data access, interoperability or cybersecurity may materially affect our business model, implementation costs and growth prospects.

We may also be subject to laws and regulations relating to the collection, processing, use, storage, sharing and protection of customer, consumer, employee, device and operational data. These may include U.S. state privacy laws, international privacy laws and industry cybersecurity expectations. Any failure to comply with these requirements, or any data breach, cybersecurity incident or service disruption, could result in liability, contractual claims, reputational damage, loss of customers, increased compliance costs or regulatory scrutiny.

Because portions of the Grid AI and AMPX business may involve participation in regulated utility or grid-adjacent environments, future growth may depend on evolving regulatory frameworks, market rules, incentive programs and utility procurement models. We cannot predict the extent to which changes in these frameworks will create opportunities or impose burdens on our operations.

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European Union Drug Development

In the European Union and the wider European Economic Area, or EEA, medicinal products may be marketed only after obtaining a marketing authorisation from the competent authorities. The EEA currently consists of the 27 European Union Member States plus Iceland, Liechtenstein and Norway. A centralised marketing authorisation granted by the European Commission is valid throughout the European Union and the EEA.

As in the United States, the preclinical, clinical, manufacturing and post-approval phases of medicinal product development in Europe are subject to extensive regulation. Clinical trials in the European Union are governed by Regulation (EU) No 536/2014, commonly referred to as the Clinical Trials Regulation, or CTR, which entered into application on January 31, 2022. The CTR replaced the prior Clinical Trials Directive regime and was intended to harmonise and streamline the submission, review, supervision and transparency of clinical trials across the European Union through a common portal and database known as the Clinical Trials Information System, or CTIS.

Clinical trials in the European Union must be conducted in accordance with the CTR, applicable national requirements and international standards for good clinical practice, or GCP. Sponsors must submit clinical trial applications through CTIS, and the regulatory and ethics review process is coordinated under the CTR framework. Trial sponsors are also subject to obligations relating to safety reporting, protocol amendments, trial transparency and public disclosure of results.

European Union Drug Review and Approval

In the EEA, medicinal products may be authorised through either the centralised procedure or national and multi-country procedures, depending on the product and applicable eligibility rules. Under the centralised procedure, a single marketing authorisation application is submitted to the European Medicines Agency, or EMA, and, if approved, the European Commission grants a single marketing authorisation valid across the European Union and the EEA.

The centralised procedure is mandatory for certain categories of medicines, including orphan medicinal products and certain biotechnology-derived medicines, and is optional for certain other innovative products that satisfy the relevant eligibility criteria. Because Adrulipase is a recombinant biologic candidate and may also potentially qualify for orphan designation depending on indication and development strategy, any future European regulatory pathway for Adrulipase would likely require or strongly favor evaluation under the centralised procedure. However, the ultimate pathway would depend on the product profile, indication, legal classification and regulatory advice at the time of any application.

Before granting a marketing authorisation, the EMA and the competent authorities evaluate the quality, safety and efficacy of the medicinal product and assess whether the benefit-risk balance is favorable.

Paediatric Requirements

Under the EU Paediatric Regulation, applications for marketing authorisation for new medicines generally must include either the results of studies performed in accordance with an agreed paediatric investigation plan, or PIP, or a decision granting a waiver or deferral. The EMA reviews compliance with the agreed PIP as part of the validation and review process. For patented products, successful completion of an agreed PIP may make the product eligible for a six-month extension of the supplementary protection certificate, if any. For orphan medicinal products, compliance with the paediatric requirements may result in a two-year extension of orphan market exclusivity. The EU also provides for a paediatric-use marketing authorisation, or PUMA, for certain products developed exclusively for use in children.

Orphan Drugs

In the European Union, a product may be designated as an orphan medicinal product if it is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition, the prevalence of the condition is not more than five in 10,000 persons in the European Union or the expected return would be insufficient to justify the investment, and no satisfactory method exists or the product would provide significant benefit over existing methods. Applications for orphan designation must be submitted before filing the marketing authorisation application.

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The European Union offers incentives to encourage the development of orphan medicines, including fee reductions, protocol assistance and market exclusivity. Once an orphan medicinal product is authorised, it is generally entitled to ten years of market exclusivity in the European Union for the approved orphan indication. This exclusivity may be extended by two additional years if the applicable paediatric requirements are satisfied. Under certain circumstances, however, a similar product may still be authorised, including with the consent of the original holder, if the original holder cannot supply sufficient quantities, or if the later product is shown to be clinically superior.

Post-Approval Controls

The holder of a European marketing authorisation must comply with ongoing requirements relating to manufacturing, pharmacovigilance, labeling, promotion, quality systems and post-authorisation commitments. The marketing authorisation holder must maintain an appropriate pharmacovigilance system and appoint a qualified person for pharmacovigilance, or QPPV, in the European Union. Marketing authorisations for new products generally must also include a risk management plan, or RMP, and regulators may impose post-authorisation safety studies, periodic safety reporting and other risk-minimisation measures.

Advertising and promotion of medicinal products in Europe must be consistent with the approved product information. Off-label promotion is prohibited, and direct-to-consumer advertising of prescription medicines is generally prohibited in the European Union. Specific advertising and promotional rules are also implemented at the Member State level and may differ by country.

Reimbursement

In the European Union, pricing and reimbursement are determined at the national level, not centrally by the EMA or the European Commission. Member States may restrict the products for which their healthcare systems provide reimbursement and may impose price controls or other cost-containment measures. As a result, even if a medicinal product receives a marketing authorisation, there can be no assurance that it will receive favorable pricing or reimbursement in any particular country. Historically, prices for medicinal products in Europe have often been lower than in the United States, and reimbursement negotiations can be lengthy and uncertain.

Other European Regulatory Matters

French Regulatory Framework for Clinical Development

In France, clinical development activities involving medicinal products are governed by the applicable provisions of Regulation (EU) No. 536/2014 on clinical trials on medicinal products for human use, together with the French Public Health Code and related national implementing measures. France also maintains national rules applicable to other categories of research involving human participants that fall outside the scope of Regulation (EU) No. 536/2014.

For clinical trials of medicinal products conducted in France under the European Union Clinical Trials Regulation, sponsors are generally required to submit applications through the Clinical Trials Information System, or CTIS, with regulatory review coordinated under the European framework and with French participation by the Agence nationale de sécurité du médicament et des produits de santé, or ANSM, and the applicable ethics committee, known as a Comité de protection des personnes, or CPP. Clinical trials must be conducted in accordance with applicable European Union law, French law and good clinical practice requirements.

Where a commercially sponsored interventional study is conducted at a French hospital, health center or similar site, the sponsor and the institution are generally required to enter into the applicable form of clinical trial agreement, commonly referred to as a convention unique, using the model required under French law. France has updated the model form over time, including more recent ministerial orders replacing earlier templates.

The processing of personal data in connection with clinical research in France is subject to the General Data Protection Regulation, or GDPR, together with French data protection law and guidance of the Commission Nationale de l’Informatique et des Libertés, or CNIL. Depending on the nature of the study and the data processing involved, sponsors and investigators may rely on CNIL reference methodologies, including MR-001 for certain health research involving consent, or may need to complete other formalities where the project falls outside the scope of an applicable reference methodology.

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France also imposes transparency, anti-benefit and anti-corruption requirements on companies operating in the health products sector. Companies manufacturing or marketing health products in France are subject to disclosure obligations regarding certain agreements, fees and benefits provided to healthcare professionals and certain other stakeholders, as well as restrictions on prohibited advantages and gifts. Violations may result in significant financial and other penalties under French law. These requirements are sometimes referred to as the French transparency or French sunshine rules and the anti-gift regime.

As a result, any future clinical development activities we may conduct in France, including any future development activity relating to Adrulipase, would be subject not only to European Union clinical trial regulation, but also to French requirements relating to site agreements, investigator and institution interactions, personal data protection, transparency reporting and anti-benefit restrictions.

Environmental Matters

Our operations, properties, technologies and services are subject to a variety of U.S. and foreign environmental, health and safety laws and regulations. These may include laws and regulations governing, among other things, air emissions, wastewater discharges, storage, handling, transport and disposal of hazardous and non-hazardous materials and waste, electronic equipment, batteries, workplace health and safety, site contamination and remediation of releases of hazardous substances.

Historically, our legacy life sciences activities have involved limited direct manufacturing operations, and we have relied on third-party manufacturers, laboratories and contractors for most research, development and manufacturing-related activities. Following our acquisition of Grid AI Corp., our business also includes software-enabled energy orchestration and related deployment activities involving distributed energy resource systems and integration with third-party energy infrastructure, including batteries, electric vehicle charging systems, HVAC systems, water heaters, solar systems and other connected devices. Although we generally do not own or operate large-scale industrial manufacturing facilities, our activities may involve environmental, permitting, storage, transportation, installation, e-waste and site-management considerations through our partners, contractors, suppliers, installers, customers and project environments.

We believe, based on information currently available to us, that we are in material compliance with environmental laws and regulations applicable to our business. However, our failure, or the failure of our contractors, suppliers, installation partners, manufacturers or site operators, to comply with existing or future environmental, health and safety requirements could result in substantial costs or liabilities. These may include cleanup costs, fines, penalties, property damage claims, personal injury claims, costs to redesign products or deployment configurations, costs to replace suppliers or contractors, business interruption, legal expenses or restrictions on operations. In addition, contamination, releases of hazardous materials, improper disposal of waste, battery-related incidents, electrical faults or other environmental events at third-party facilities, customer sites or project locations could adversely affect our business, financial condition and results of operations.

Employees

As of December 31, 2025, we had 2 full-time employees at the parent company level. In addition, we rely on consultants, contractors and employees of our subsidiaries and affiliated entities to support our operations, including software development, engineering, finance, regulatory, administrative and other functions. None of our employees are represented by a labor union, and we consider our employee relations to be good.

Available Information

As a public company, we are required to file annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, proxy statements on Schedule 14A and other information, including amendments to those reports, with the Securities and Exchange Commission, or SEC. The SEC maintains an Internet website that contains reports, proxy and information statements and other information regarding issuers that file electronically with the SEC. Our SEC filings are available to the public at the SEC’s website at www.sec.gov.

Our Internet address is https://grid-ai.com. Information contained on our website is not incorporated by reference into and does not constitute part of this Annual Report. Our SEC filings, including any amendments, will be made available free of charge on our website as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC.

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ITEM 1A.RISK FACTORS

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We are subject to numerous risks and uncertainties that could materially adversely affect our business, financial condition, results of operations and the value of our securities. The risks described below are not the only risks we face. Additional risks and uncertainties not presently known to us, or that we currently consider immaterial, may also materially adversely affect us. If any of the following risks occur, our business, financial condition, results of operations and prospects could be materially harmed, and the trading price of our Common Stock could decline, potentially causing investors to lose all or part of their investment.

Summary of Risk Factors

An investment in our securities involves a high degree of risk. The principal risks relating to our business and securities include the following:

● We will face intense competition and may not be able to compete successfully.

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Risks Related to Our Business, Financial Position and Capital Requirements

Our current dependency on external funding for our operations raises a substantial doubt about our ability to continue as a going concern. If we do not continue as a going concern, investors could lose their entire investment.

The accompanying consolidated financial statements have been prepared as if we will continue as a going concern. We have incurred significant operating losses and negative cash flows from operations since inception. On December 31, 2025, we had cash and cash equivalents of approximately $0.9 million, and an accumulated deficit of approximately $208.8 million. We have incurred recurring losses, have experienced recurring negative operating cash flows, and require significant cash resources to execute our business plans. Based on cash on hand at December 31, 2025 and the available loan proceeds and assuming successful financing efforts, which we cannot guarantee, we anticipate having sufficient cash to fund planned operations for the next several months. Historically, our major sources of cash have been comprised of proceeds from various public and private offerings of its capital stock. Although our business changed significantly during 2025 through the acquisition of Grid AI Corp. and the completion of the ImmunogenX rescission transaction, we are dependent on obtaining additional working capital funding from the sale of equity and/or debt securities in order to continue to execute our development plans and continue operations.

We have been, and are expected to continue, exploring various potential strategies available including but not limited to raising capital, restructuring our indebtedness and identifying and evaluating potential strategic alternatives but there can be no assurance that these efforts will be successful, that the Company will be able to raise necessary capital on acceptable terms, reach agreement with lenders, or that the strategic review process will result in the Company pursuing any transaction or that any transaction, if pursued, will be completed on attractive terms or at all. We are evaluating all potential strategic options, including a merger, reverse merger, sale, wind-down, liquidation and dissolution or other strategic transaction. Additionally, there can be no assurances that any particular course of action, business arrangement or transaction, or series of transactions, will be pursued, successfully consummated or lead to increased stakeholder value or that it will make any cash distributions to stockholders. Any failure in these efforts could force us to delay, limit or terminate operations, make reductions in our workforce, discontinue research and development programs, liquidate all or a portion of assets or pursue other strategic alternatives, and/or seek protection under the provisions of the U.S. Bankruptcy Code.

Without adequate working capital, we may not be able to meet our obligations and continue as a going concern. These conditions raise substantial doubt about our ability to continue as a going concern one year from the date these financial statements are issued. If the Company is not able to obtain necessary capital, we may be required to terminate operations, liquidate all or a portion of assets and/or seek bankruptcy protection. As a result, we have concluded that our plans at this stage do not alleviate substantial doubt about the ability to continue as a going concern. Our financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Our level of indebtedness and our ability to make payments on or service our indebtedness could adversely affect our business, financial condition, results of operations, cash flow and liquidity.

Effective January 31, 2025, we entered into the Revolving Loan Agreement. Pursuant to and under the terms of the Revolving Loan Agreement, we issued to the Lender a revolving note dated January 27, 2025 in the principal amount of $2,000,000. Out of the principal amount, the Lender disbursed an initial loan amount of $550,000 to the Company on January 31, 2025.

The Revolving Note bears interest at the rate of 18% per annum calculated on the basis of a 360-day year, consisting of twelve 30 calendar day periods, and shall accrue daily commencing on January 31, 2025 until paid in full. The outstanding principal balance, all accrued and unpaid interest and all other amounts, costs, expenses and/or liquidated damages are due in full on January 31, 2026. The Revolving Loan Agreement contains customary events of default. As of April 1, 2026, the Company was in default under the

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Revolving Loan Agreement as a result of its failure to repay amounts due at maturity, and the lender has issued a demand for repayment of the outstanding amounts.

If we are not able to repay or refinance our debt as it becomes due, we may be required to adopt one or more alternatives, such as selling assets, restructuring debt or obtaining additional debt or equity on terms that may be onerous or highly dilutive, if we can obtain it at all. If we raise equity through the issuance of preferred stock, the terms of the preferred stock may give the holders rights, preferences and privileges senior to those of holders of our Common Stock, particularly in the event of liquidation. Our ability to arrange financing or refinancing will depend on, among other factors, our financial position and performance, as well as prevailing market conditions and other factors beyond our control. We cannot assure you that we will be able to obtain financing or refinancing on terms acceptable to us or at all.

If funds are not available when needed, or available on acceptable terms, we may be required to delay, scale back or eliminate some of our obligations. In addition, we may not be able to grow market share, take advantage of future opportunities or respond to competitive pressures or unanticipated requirements, which could negatively impact our business, operating results and financial condition.

We will require substantial additional financing to achieve our goals, and a failure to obtain this necessary capital when needed and on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product candidate development programs, testing efforts or other operations, including.

We expect our expenses to increase in connection with our ongoing activities, including with connection to the operating of Grid AI Corp. and AMPX. We also expect to incur significant expenses related to the development, testing, and manufacturing of our product candidates. We cannot reasonably estimate the actual amounts necessary to successfully complete the development and commercialization of our products. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. If we are unable to raise capital when needed or on attractive terms, we could be forced to delay, reduce or eliminate our research and development programs or any potential future commercialization efforts.

We have based our estimates on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently expect. Our operating plans and other demands on our cash resources may change as a result of many factors, including costs required to advance Adrulipase, the pace of commercialization and development of the Grid AI Corp. and AMPX platform, as well as factors currently unknown to us, and we may need to seek additional funds sooner than planned, through public or private equity or debt financings or other capital sources, including potentially government funding, collaborations, licenses and other similar arrangements. In addition, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. Attempting to secure additional financing may divert our management from its day-to-day activities, which may adversely affect our ability to develop our product candidates.

Our future capital requirements will depend on many factors, including:

● the costs and timing of manufacturing for our product candidates;

● operating and integrating the Grid AI Corp. and AMPX business and

Additional offerings in the future may dilute then existing stockholders’ percentage ownership of our Company.

Given our plans and expectations that we will need additional capital, in the near future we may need to issue additional Common Stock or securities convertible or exercisable for Common Stock, including convertible preferred shares, convertible notes, stock options or warrants.

In particular, the September 30, 2025 Grid AI Corp. transaction included the issuance of Series H Non-Voting Convertible Preferred Stock that is convertible, subject to conditions, into a substantial number of shares of Common Stock. We also have outstanding warrants and other equity-linked instruments, and we granted equity awards to management and directors in late 2025 and early 2026.

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These instruments may significantly dilute existing stockholders, both economically and voting-wise, if converted, exercised or settled in shares.

The issuance of additional securities in the future will dilute the percentage ownership of then existing stockholders. Additionally, sales by existing stockholders of a large number of our Common Stock in the public market could also affect the market price of our Common Stock.

We experienced significant board and management turnover during the fourth quarter of 2025, and instability in governance and leadership could adversely affect our business.

In late 2025, we underwent significant governance and leadership changes, including board resignations, changes in board composition, a new Chief Executive Officer arrangement, a new Interim Chief Financial Officer and new equity awards to management and directors. One director resignation was accompanied by stated disagreements regarding governance, diligence and disclosure matters.

These events could adversely affect us by:

● disrupting strategic execution

● weakening internal controls or disclosure controls

● diverting management attention

● increasing legal, accounting and administrative burden

● impairing our ability to recruit, retain and motivate qualified personnel

If we are unable to maintain stable and effective leadership, our business and reporting quality may be adversely affected.

Disruptions in the global economy and supply chains may have a material adverse effect on our business, financial condition and results of operations.

Our operations are subject to risks arising from global economic conditions, supply chain disruptions and volatility in energy markets. These risks may affect the availability, cost and timing of components, infrastructure and third-party services required to support the development and deployment of our energy orchestration platform and related technologies.

Global supply chains have experienced significant disruption in recent years, and ongoing geopolitical conflicts, trade tensions, inflationary pressures and macroeconomic uncertainty continue to impact market conditions. In particular, disruptions affecting the energy sector, data center infrastructure and related equipment could adversely affect our ability to scale our platform, deliver services to customers and execute our business strategy.

In addition, inflationary pressures and volatility in labor, technology and infrastructure costs may increase our operating expenses and reduce our financial flexibility. Any such disruptions or adverse developments could materially and adversely affect our business, financial condition and results of operations.

Adverse global conditions, including economic uncertainty, may negatively impact our financial results.

Global conditions, dislocations in the financial markets, any negative financial impacts affecting United States as a result of tax reform or changes to existing trade agreements or tax conventions, may adversely impact our business.

In addition, the global macroeconomic environment could be negatively affected by, among other things, pandemics or epidemics, instability in global economic markets, increased U.S. trade tariffs and trade disputes with other countries, instability in the

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global credit markets, supply chain weaknesses, instability in the geopolitical environment as a result of the Russian invasion of Ukraine, conflicts in the Middle East, and foreign governmental debt concerns. Such challenges have caused, and may continue to cause, uncertainty and instability in local economies and in global financial markets.

Acceptance of digital assets, including stablecoins, as consideration in our transactions may expose us to volatility, regulatory uncertainty and accounting complexity, which could adversely affect our financial results.

We are evaluating the planned acceptance of stablecoins and other digital assets as a form of consideration in certain future transactions. The use of digital assets may expose us to risks, including potential fluctuations in value, even for assets intended to maintain a stable value, as well as risks related to cybersecurity, custody, and reliance on third-party platforms and infrastructure. In addition, the regulatory environment for digital assets continues to evolve, and changes in laws, regulations, or interpretations by regulatory authorities could affect our ability to accept or use such assets or impose additional compliance obligations.

The accounting treatment of digital assets under U.S. GAAP is complex and subject to interpretation. Certain digital assets may be required to be measured at fair value with changes recognized in earnings, which could introduce volatility into our financial results. Other digital assets may be accounted for as indefinite-lived intangible assets and subject to impairment testing, which could result in non-cash impairment charges. Although we did not hold any digital assets as of December 31, 2025, if we elect to accept or hold such assets in the future, these risks could adversely affect our financial condition and results of operations.

Geopolitical risks associated with Russia’s invasion of Ukraine and conflicts in the Middle East, including the U.S. and Israel war with Iran, could result in increased market volatility and uncertainty, which could negatively impact our business, financial condition, and results of operations.

The uncertain nature, scope, magnitude, and duration of hostilities stemming from Russia’s military invasion of Ukraine and conflicts in the Middle East, including the U.S. and Israel war with Iran, including the potential effects of such hostilities as well as sanctions, embargoes, asset freezes, cyber-attacks and other actions taken in response to such hostilities on the world economy and markets, have disrupted global markets and contributed to increased market volatility and uncertainty, which could have an adverse impact on macroeconomic and other factors that affect our business and supply chain. There can be no certainty regarding the impacts stemming from the invasion, including the imposition of additional sanctions, embargoes, asset freezes or other economic or military measures resulting from the invasion. The impact of these developments, and additional events that may occur as a result, is currently unknown and could adversely affect our business, supply chain, suppliers and customers and potential customers. It is not possible to predict the broader consequences of this conflict, which could include further sanctions, embargoes, regional instability, geopolitical shifts and adverse effects on macroeconomic conditions, the availability and cost of materials, supplies, labor, currency exchange rates and financial markets, all of which could negatively impact our business, financial condition and results of operations.

Significant disruptions of information technology systems or breaches of data security could materially adversely affect our business, results of operations and financial condition.

We collect and maintain information in digital form that is necessary to conduct our business, and we are increasingly dependent on information technology systems and infrastructure to operate our business. In the ordinary course of our business, we collect, store and transmit large amounts of confidential information, including intellectual property, proprietary business information and personal information. It is critical that we do so in a secure manner to maintain the confidentiality and integrity of such confidential information. We have established physical, electronic and organizational measures to safeguard and secure our systems to prevent a data compromise, and rely on commercially available systems, software, tools, and monitoring to provide security for our information technology systems and the processing, transmission and storage of digital information. We have also outsourced elements of our information technology infrastructure, and as a result a number of third-party vendors may or could have access to our confidential information. Our internal information technology systems and infrastructure, and those of our current and any future collaborators, contractors and consultants and other third parties on which we rely, are vulnerable to damage from computer viruses, malware, natural disasters, terrorism, war, telecommunication and electrical failures, cyber-attacks or cyber-intrusions over the Internet, attachments to emails, persons inside our organization, or persons with access to systems inside our organization.

The risk of a security breach or disruption, particularly through cyber-attacks or cyber-intrusion, including by computer hackers, foreign governments and cyber-terrorists, has generally increased as the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased. In addition, the prevalent use of mobile devices that access confidential information increases the risk of data security breaches, which could lead to the loss of confidential information or other intellectual property. The

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costs to us to mitigate network security problems, bugs, viruses, worms, malicious software programs and security vulnerabilities could be significant, and while we have implemented security measures to protect our data security and information technology systems, our efforts to address these problems may not be successful, and these problems could result in unexpected interruptions, delays, cessation of service and other harm to our business and our competitive position. If such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our product development programs. For example, the loss of clinical trial data from completed or ongoing or planned clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. Moreover, if a computer security breach affects our systems or results in the unauthorized release of personally identifiable information, our reputation could be materially damaged.

In addition, such a breach may require notification to governmental agencies, the media or individuals pursuant to various federal and state privacy and security laws, if applicable, including the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Clinical Health Act of 2009, and its implementing rules and regulations, as well as regulations promulgated by the Federal Trade Commission and state breach notification laws.

Under the EU regulation and notably the General Data Protection Regulation, or GDPR, No. 2016/679, which entered into force on May 25, 2018 and is applicable personal data that we process in relation to our presence in the EU, the offering of products or services to individuals in the EU or the monitoring of the behavior of individuals in the EU, we have also a legal responsibility to report personal data breaches to the competent supervisory authority. The EU data protection regulation includes a broad definition and a short deadline for the notification of personal data breaches, which may be difficult to implement in practice and requires that we implement robust internal processes. Under this regulation, we have to report personal data breaches to the competent supervisory authority within 72 hours of the time we become aware of a breach “unless the personal data breach is unlikely to result in a risk to the right and freedoms of natural persons” (Article 33 of the GDPR). In addition, the GDPR requires that we communicate the breach to the Data Subject if the breach is “likely to result in a high risk to the rights and freedoms of natural persons” (Article 34 of the GDPR). In order to fulfil these requirements, we have to implement specific internal processes to be followed in case of a personal data breach, which will allow us to (a) contain and recover the breach, (b) assess the risk to the data subjects, (c) notify, and possibly communicate the breach to the data subjects, (d) investigate and respond to the breach. The performance of these processes implies substantial costs in resources and time.

Moreover, as we may rely on third parties that will also process as processor the data for which we are a data controller—for example, in the context of the manufacturing of our product candidates or for the conduct of clinical trials, we must contractually ensure that strict security measures, as well as appropriate obligations including an obligation to report in due delay any security incident are implemented, in order to allow us fulfilling our own regulatory requirements.

We would also be exposed to a risk of loss or litigation and potential liability for any security breach on personal data for which we are data controller. The costs of above-mentioned processes together with legal penalties, possible compensation for damages and any resulting lawsuits arising from a breach may be extensive and may have a negative impact on reputation and materially adversely affect our business, results of operations and financial condition.

Requirements associated with being a public company will increase our costs significantly and will divert significant company resources and management attention.

Since we are no longer an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, we are no longer able to take advantage of certain exemptions from various reporting requirements that were previously available to us, but which were not available to other public companies that are not emerging growth companies. Accordingly, we will be required to comply with increased disclosure obligations regarding executive compensation in our periodic reports and proxy statements and the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved. As a result, we will incur greater expenses associated with such reporting requirements. These expenses would further increase if we ceased to be a “smaller reporting company.” In addition, if we are deemed an accelerated filer or large accelerated filer in the future, we expect to incur additional management time and cost to comply with the more stringent reporting requirements applicable to companies that are deemed accelerated filers or large accelerated filers, including complying with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act. We have not yet completed the process of compiling the system and processing documentation needed to comply with such requirements. We may not be able to complete our evaluation, testing and any required remediation in a timely fashion when required to do so. In that regard, we currently do not have an internal audit function, and we will need to hire or contract additional accounting and financial staff with appropriate public company experience and technical accounting knowledge.

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Our management and other personnel need to devote a substantial amount of time to these compliance initiatives. Moreover, these rules and regulations will increase our legal and financial compliance costs and will make some activities more time-consuming and costly. We cannot predict or estimate the amount of additional costs we may incur as a result of this.

Risks Related to our Biopharmaceutical Operation, Clinical Development, Regulatory Approval and Commercialization

We operate as a clinical stage biopharmaceutical company with relation to our retained biopharmaceutical assets but have a limited operating history upon which to base an investment decision.

We operate as a clinical stage biopharmaceutical company with relation to our retained biopharmaceutical assets. Following the completion of the ImmunogenX rescission transaction on December 31, 2025, our retained legacy biopharmaceutical focus is primarily Adrulipase. Adrulipase is in the early stages of clinical development. We have not generated any revenue from product sales and have incurred significant net losses. We have not demonstrated our ability to perform the functions necessary for the successful commercialization of any product candidates. The successful commercialization of any of our products will require us to perform a variety of functions, including:

● continuing to undertake pre-clinical development and clinical trials;

● participating in regulatory approval processes;

● formulating and manufacturing products; and

● conducting sales and marketing activities.

Our operations to date have been limited to organizing and staffing, acquiring, developing and securing the proprietary rights for, and undertaking pre-clinical development, manufacturing and clinical trials of Adrulipase. These operations provide a limited basis for our stockholders and prospective investors to assess our ability to complete development of or commercialize Adrulipase or any other product candidates and the advisability of investing in our securities.

We have incurred significant losses and negative cash flows from our operations since inception. As of December 31, 2025, we had accumulated deficit of approximately $208.8 million and negative working capital of approximately $12.6 million. Based on our historical and anticipated rate of cash expenditures, we do not anticipate our existing working capital will be sufficient to sustain our business through the commercialization of our product candidates. Therefore, we are dependent on obtaining, and are continuing to pursue, the necessary funding from outside sources, including obtaining additional funding from the sale of securities in order to continue our operations. We are actively working to obtain additional funding. We cannot make any assurances that additional financings will be available to us and, if available, completed on a timely basis, on acceptable terms or at all. If we are unable to complete an equity and/or debt offering, or otherwise obtain sufficient financing when and if needed, it would negatively impact our business and operations, which would likely cause the price of our Common Stock to decline or ultimately force us to cease our operations.

The development and regulatory approval process take several years, and it is not likely that any such products, even if successfully developed and approved by the FDA or any comparable foreign regulatory authority, would be commercially available for a significant period of time. Many promising drug candidates fail at some stage of their clinical development. Accordingly, even if we are able to obtain the requisite financing to fund our development programs, we cannot assure you that our product candidates will be successfully developed, receive required regulatory approvals and successfully commercialized. Our failure to develop, manufacture or receive regulatory approval for or successfully commercialize any of our product candidates, could result in the failure of our business and a loss of all of your investment in our company.

We will face intense competition and may not be able to compete successfully.

We operate in highly competitive segments of the biotechnology and biopharmaceutical markets. We face competition from many different sources, including commercial pharmaceutical and biotechnology enterprises, academic institutions, government agencies, and private and public research institutions. Adrulipase, if successfully developed and approved, will compete with established therapies, as well as new treatments that may be introduced by our competitors. Many of our competitors have significantly greater financial, product development, manufacturing and marketing resources than us. Large pharmaceutical companies have extensive experience in clinical testing and obtaining regulatory approval for drugs. We also may compete with these organizations to recruit

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management, scientists and clinical development personnel. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. New developments, including the development of other biological and pharmaceutical technologies and methods of treating disease, occur in the pharmaceutical and life sciences industries at a rapid pace. Developments by competitors may render our product candidates obsolete or noncompetitive. We will also face competition from these third parties in recruiting and retaining qualified personnel, establishing clinical trial sites and patient registration for clinical trials and in identifying and in-licensing new product candidates.

We may incur substantial product liability or indemnification claims relating to the use of our product candidates.

We face an inherent risk of product liability exposure based on the use of Adrulipase in human clinical trials, or, if obtained, following marketing approval and commercialization. Claims could be brought against us if use or misuse of one of our product candidates causes, or merely appears to have caused, personal injury or death. Although we have and intend to maintain product liability insurance relating to our clinical trials, our coverage may not be sufficient to cover claims that may be made against us and we may be unable to maintain such insurance. Any claims against us, regardless of their merit, could severely harm our financial condition, strain our management and other resources or destroy the prospects for commercialization of the product which is the subject of any such claim. We are unable to predict if we will be able to obtain or maintain product liability insurance for any products that may be approved for marketing. Additionally, we have entered into various agreements where we indemnify third parties for certain claims relating to the testing and use of our product candidates. These indemnification obligations may require us to pay significant sums of money for claims that are covered by these indemnifications.

We cannot predict all of the possible harms or side effects that may result from the use of our products and, therefore, the amount of insurance coverage we currently hold, or that we or our collaborators may obtain, may not be adequate to protect us from any claims arising from the use of our products that are beyond the limit of our insurance coverage. If we cannot protect against potential liability claims, we or our collaborators may find it difficult or impossible to commercialize our products, and we may not be able to renew or increase our insurance coverage on reasonable terms, if at all. The marketing, sale and use of our products and our planned future products could lead to the filing of product liability claims against us if someone alleges that our products failed to perform as designed. A product liability or professional liability claim could result in substantial damages and be costly and time-consuming for us to defend.

Any product liability or professional liability claim brought against us, with or without merit, could increase our insurance rates or prevent us from securing insurance coverage. Additionally, any product liability lawsuit could damage our reputation, result in the recall of products, or cause current partners to terminate existing agreements and potential partners to seek other partners, any of which could impact our results of operations.

We may use biological materials and may use hazardous materials, and any claims relating to improper handling, storage or disposal of these materials could be time consuming or costly.

We may use hazardous materials, including chemicals and biological agents and compounds, that could be dangerous to human health and safety or the environment. Our operations also produce hazardous waste products. Federal, state and local laws and regulations govern the use, generation, manufacture, storage, handling and disposal of these materials and wastes. Compliance with applicable environmental laws and regulations may be expensive, and current or future environmental laws and regulations may impair our product development efforts. In addition, we cannot entirely eliminate the risk of accidental injury or contamination from these materials or wastes. We do not carry specific biological or hazardous waste insurance coverage and our property and casualty, and general liability insurance policies specifically exclude coverage for damages and fines arising from biological or hazardous waste exposure or contamination. Accordingly, in the event of contamination or injury, we could be held liable for damages or penalized with fines in an amount exceeding our resources, and our clinical trials or regulatory approvals could be suspended.

Although we maintain workers’ compensation insurance to cover us for costs and expenses, we may incur due to injuries to our employees resulting from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities. We do not maintain insurance for environmental liability or toxic tort claims that may be asserted against us in connection with our storage or disposal of biological or hazardous materials.

In addition, we may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations. These current or future laws and regulations may impair our research, development or production efforts. Failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions.

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We will need to grow the size of our organization, and we may experience difficulties in managing this growth.

As of December 31, 2025, we had 18 full-time employees. As our development and commercialization plans and strategies develop, we expect to need additional managerial, operational, research and development, sales, marketing, financial and other personnel. Future growth would impose significant added responsibilities on members of management, including:

Our future financial performance and our ability to commercialize our product candidates will depend, in part, on our ability to effectively manage any future growth, and our management may also have to divert a disproportionate amount of its attention away from day-to-day activities in order to devote a substantial amount of time to managing these growth activities.

We currently rely, and for the foreseeable future will continue to rely, in substantial part on certain independent organizations, advisors and consultants to provide certain services, including certain aspects of regulatory approval, clinical management and manufacturing. There can be no assurance that the services of independent organizations, advisors and consultants will continue to be available to us on a timely basis when needed, or that we can find qualified replacements. In addition, if we are unable to effectively manage our outsourced activities or if the quality or accuracy of the services provided by consultants is compromised for any reason, our clinical trials may be extended, delayed or terminated, and we may not be able to obtain regulatory approval of our product candidates or otherwise advance our business. There can be no assurance that we will be able to manage our existing consultants and contractors or find other competent outside contractors and consultants on economically reasonable terms, or at all.

If we are not able to effectively expand our organization by hiring new employees and expanding our groups of consultants and contractors, we may not be able to successfully implement the tasks necessary to further develop and commercialize our product candidates and, accordingly, may not achieve our research, development and commercialization goals.

Any product candidates we advance into and through clinical development are subject to extensive regulation, which can be costly and time consuming, cause unanticipated delays or prevent the receipt of the required approvals to commercialize our product candidates.

The clinical development, manufacturing, labeling, storage, record-keeping, advertising, promotion, import, export, marketing and distribution of our product candidates are subject to extensive regulation by the FDA in the United States and by comparable health authorities in foreign markets, including Health Canada’s Therapeutic Products Directorate, or the TPD, and the European Medicines Agency, or the EMA. In the United States, we are not permitted to market our product candidates until we receive approval of an NDA (New Drug Application) or BLA (Biologic License Application) from the FDA. The process of obtaining such approval is expensive, often takes many years and can vary substantially based upon the type, complexity and novelty of the products involved. In addition to the significant clinical testing requirements, our ability to obtain marketing approval for these product candidates depends on obtaining the final results of required non-clinical testing, including characterization of the manufactured components of our product candidates and validation of our manufacturing processes. The FDA may determine that our product manufacturing processes, testing procedures or facilities are insufficient to justify approval. Approval policies or regulations may change, and the FDA has substantial discretion in the pharmaceutical approval process, including the ability to delay, limit or deny approval of a product candidate for many reasons. Despite the time and expense invested in clinical development of product candidates, regulatory approval is never guaranteed.

The FDA, the TPD and/or the EMA can delay, limit or deny approval of a product candidate for many reasons, including, but not limited to:

● disagreement with the design or implementation of our clinical trials;

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Any delay in obtaining, or inability to obtain, applicable regulatory approvals would prevent us from commercializing our product candidates.

If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.

We may experience difficulties in patient enrollment in our clinical trials for a variety of reasons. The timely completion of clinical trials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient number of patients who remain in the trial until its conclusion. The enrollment of patients depends on many factors, including:

● the patient eligibility criteria defined in the protocol;

● the size of the patient population;

● the design of the trial;

● our ability to obtain and maintain patient consents; and

Our clinical trials will compete with other clinical trials for product candidates that are in the same therapeutic areas as our product candidates. This competition will reduce the number and types of patients and qualified clinical investigators available to us, because some patients who might have opted to enroll in our trials may instead opt to enroll in a trial being conducted by one of our competitors or clinical trial sites may not allow us to conduct our clinical trial at such site if competing trials are already being conducted there. Since the number of qualified clinical investigators is limited, we expect to conduct some of our clinical trials at the same clinical trial sites that some of our competitors use, which will reduce the number of patients who are available for our clinical trials in such clinical trial site. We may also encounter difficulties finding a clinical trial site at which to conduct our trials.

Delays in patient enrollment may result in increased costs or may affect the timing or outcome of our planned clinical trials, which could prevent completion of these clinical trials and adversely affect our ability to advance the development of our product candidates.

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Because the results of preclinical studies and early clinical trials are not necessarily predictive of future results, any product candidate we advance into clinical trials may not have favorable results in later clinical trials, if any, or receive regulatory approval.

Pharmaceutical development has inherent risk. We will be required to demonstrate through well-controlled clinical trials that our product candidates are safe and effective with a favorable benefit-risk profile for use in their target indications before we can seek regulatory approvals for their commercial sale. Adrulipase has completed four Phase 2 clinical trials in two separate indications (three Phase 2 in CF patients and one Phase 2 in CP patients). Success in pre-clinical studies or early clinical trials does not mean that later clinical trials will be successful, as product candidates in later-stage clinical trials may fail to demonstrate sufficient safety or efficacy despite having progressed through initial clinical testing. We also may need to conduct additional clinical trials that are not currently anticipated. Drug developers frequently suffer significant setbacks in advanced clinical trials, even after earlier clinical trials have shown promising results.

Any product candidate we advance into and through clinical trials may cause unacceptable adverse events or have other properties that may delay or prevent their regulatory approval or commercialization or limit their commercial potential.

Unacceptable adverse events caused by Adrulipase in clinical trials could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in the denial of regulatory approval by the FDA or other regulatory authorities for any or all targeted indications and markets. This, in turn, could prevent us from commercializing the affected product candidate and generating revenues from its sale. We have not yet completed testing of any of our product candidates for the treatment of the indications for which we intend to seek product approval in humans, and we currently do not know the extent of adverse events, if any, that will be observed in patients who receive any of our product candidates. If any of our product candidates cause unacceptable adverse events in clinical trials, we may not be able to obtain regulatory approval or commercialize such product or, if such product candidate is approved for marketing, future adverse events could cause us to withdraw such product from the market.

Delays in the commencement or completion of our clinical trials could result in increased costs and delay our ability to pursue regulatory approval and commercialization of our product candidates.

The commencement and completion of clinical trials can be delayed for a variety of reasons, including delays in:

● obtaining regulatory clearance to commence a clinical trial;

● identifying, recruiting and training suitable clinical investigators;

● availability of funds.

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Any delays in the commencement of our clinical trials will delay our ability to pursue regulatory approval for our product candidates. In addition, many of the factors that cause, or lead to, a delay in the commencement of clinical trials may also ultimately lead to the denial of regulatory approval of a product candidate.

We may be required to suspend, repeat or terminate our clinical trials if they are not conducted in accordance with regulatory requirements, the results are negative or inconclusive or the trials are not well designed.

Regulatory agencies, IRBs or data safety monitoring boards may at any time recommend the temporary or permanent discontinuation of our clinical trials or request that we cease using investigators in the clinical trials if they believe that the clinical trials are not being conducted in accordance with applicable regulatory requirements, or that they present an unacceptable safety risk to participants. Clinical trials must be conducted in accordance with current cGCPs or other applicable foreign government guidelines governing the design, safety monitoring, quality assurance and ethical considerations associated with clinical studies. Clinical trials are subject to oversight by the FDA, other foreign governmental agencies and IRBs at the study sites where the clinical trials are conducted. In addition, clinical trials must be conducted with product candidates produced in accordance with applicable cGMPs, which are the FDA’s regulations governing the design, monitoring and control of manufacturing processes and facilities. Clinical trials may be suspended by the FDA, other foreign governmental agencies, or us for various reasons, including:

● deficiencies in the clinical trial operations or trial sites;

● the product candidate may have unforeseen adverse side effects;

● deficiencies in the trial design necessary to demonstrate efficacy;

If we elect or are forced to suspend or terminate a clinical trial for Adrulipase, the commercial prospects for that product candidate will be harmed and our ability to generate product revenue from that product candidate may be delayed or eliminated. Furthermore, any of these events could prevent us or our partners from achieving or maintaining market acceptance of the affected product candidate and could substantially increase the costs of commercializing our product candidates and impair our ability to generate revenue from the commercialization of these product candidates either by us or by our collaboration partners.

The approval processes of regulatory authorities are lengthy, time consuming, expensive and inherently unpredictable. If we are unable to obtain approval for our product candidates from applicable regulatory authorities, we will not be able to market and sell those product candidates in those countries or regions and our business will be substantially harmed.

The time required to obtain approval by the FDA and comparable foreign authorities is unpredictable but typically takes many years following the commencement of clinical trials and depends upon numerous factors, including the substantial discretion of the regulatory authorities. We have not submitted an NDA or similar filing or obtained regulatory approval for any drug candidate in any jurisdiction and it is possible that none of our existing product candidates or any product candidates we may seek to develop in the future will ever obtain regulatory approval.

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Adrulipase could fail to receive regulatory approval for many reasons, including any one or more of the following:

● invest significant additional cash in each of the above activities; and

The time and expense of the approval process, as well as the unpredictability of clinical trial results and other contributing factors, may result in our failure to obtain regulatory approval to market, in one or more jurisdictions, Adrulipase, or future product candidates, which would significantly harm our business, results of operations and prospects.

In addition, even if we were to obtain regulatory approval in one or more jurisdictions, regulatory authorities may approve Adrulipase for fewer or more limited indications than we request, may not approve the prices we may propose to charge for our products, may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve a product candidate with labeling that does not include the claims necessary or desirable for the successful commercialization of that product candidate. Any of the foregoing circumstances could materially harm the commercial prospects for Adrulipase.

Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of the approved labeling, or result in significant negative consequences following marketing approval, if any.

Results of current and future clinical trials of Adrulipase could reveal a high and/or unacceptable severity and frequency of these or other side effects. In such an event, our trials could be suspended or terminated, and the FDA or comparable foreign regulatory authorities could order us to cease further development of, or deny approval of, our product candidates for any or all targeted indications. Further, any observed drug-related side effects could affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims. Any of these occurrences could materially harm our business, financial condition and prospects.

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Additionally, if Adrulipase receive marketing approval, and we or others later identify undesirable side effects caused by our products, a number of potentially significant negative consequences could result, including:

● regulatory authorities may withdraw approvals of such product;

● we could be sued and held liable for harm caused to patients; and

● our reputation may suffer.

Any of these events could prevent us from achieving or maintaining market acceptance of the particular product, if approved, and could significantly harm our business, results of operations and prospects.

If we are unable to execute our sales and marketing strategy for our products and are unable to gain market acceptance, we may be unable to generate sufficient revenue to sustain our business.

We operate as a clinical-stage biopharmaceutical company with relation to our Biopharmaceutical assets and have yet to begin to generate revenue from Adrulipase. Our product candidate is in an early stage of clinical development, and, if we obtain marketing approval for any of products in the future, which we anticipate would not occur for several years, if at all.

We may never gain significant market acceptance for our product candidates and therefore may never generate substantial revenue or profits for us. We will need to establish a market for any of our product candidates that receive regulatory approval through physician education, sales and marketing efforts, awareness programs and the publication of clinical data. Gaining acceptance in medical communities requires, among other things, publication in leading peer-reviewed journals of results from our studies. The process of publication in leading medical journals is subject to a peer review process and peer reviewers may not consider the results of our studies sufficiently novel or worthy of publication. Failure to have our studies published in peer-reviewed journals could limit the adoption of Adrulipase. Our ability to successfully market our product candidates that we may develop will depend on numerous factors, including:

● the efficacy and safety as demonstrated in clinical trials;

● the clinical indications for which the product is approved;

● relative convenience and ease of administration;

● whether our current or future partners, support our offerings;

● the success of the sales force and marketing effort;

● unfavorable publicity relating to the product;

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We currently have no commercial organization. If we are unable to establish satisfactory sales and marketing capabilities or secure a sales and marketing partner, we may not successfully commercialize any of our product candidates.

We have no commercial infrastructure. In order to commercialize products that are approved for marketing, we must either establish our own sales and marketing infrastructure or collaborate with third parties that have such commercial infrastructure.

We may not be able to enter into collaboration agreements on terms acceptable to us or at all. In addition, even if we enter into such relationships, we may have limited or no control over the sales, marketing and distribution activities of these third parties. Our future revenues may depend heavily on the success of the efforts of these third parties. If we elect to establish a sales and marketing infrastructure, we may not realize a positive return on this investment. In addition, we will have to compete with established and well-funded pharmaceutical and biotechnology companies to recruit, hire, train and retain sales and marketing personnel. Factors that may inhibit our efforts to commercialize our product candidates without strategic partners or licensees include:

If we are not successful in recruiting sales and marketing personnel or in building a sales and marketing infrastructure, or if we do not successfully enter into appropriate collaboration arrangements, we will have difficulty successfully commercializing our product candidates and any we may develop or acquire, which would adversely affect our business, operating results and financial condition. Outside the United States, we may commercialize our product candidates by entering into collaboration agreements with pharmaceutical partners. We may not be able to enter into such agreements on terms acceptable to us or at all. In addition, even if we enter into such relationships, we may have limited or no control over the sales, marketing and distribution activities of these third parties. Our future revenues may depend heavily on the success of the efforts of these third parties.

We may form or seek strategic alliances or enter into additional licensing arrangements in the future, and we may not realize the benefits of such alliances or licensing arrangements.

From time to time, we may form or seek strategic alliances, create joint ventures or collaborations or enter into additional licensing arrangements with third parties that we believe will complement or augment our development and commercialization efforts with respect to Adrulipase and any future product candidates that we may develop. Any of these relationships may require us to incur non-recurring and other charges, increase our near and long-term expenditures, issue securities that dilute our existing stockholders or disrupt our management and business. These relationships also may result in a delay in the development of Adrulipase if we become dependent upon the other party and such other party does not prioritize the development of our product candidates relative to its other development activities. In addition, we face significant competition in seeking appropriate strategic partners and the negotiation process is time-consuming and complex. Moreover, we may not be successful in our efforts to establish a strategic partnership or other alternative arrangements for our product candidates because they may be deemed to be at too early of a stage of development for collaborative effort and third parties may not view our product candidates as having the requisite potential to demonstrate safety and efficacy. If we license products or businesses, we may not be able to realize the benefit of such transactions if we are unable to successfully integrate them with our existing operations and company culture. We cannot be certain that, following a strategic transaction or license, we will achieve the revenue or specific net income that justifies such transaction. We rely completely on third parties to manufacture our preclinical and clinical pharmaceutical supplies and expect to continue to rely on third parties to produce commercial supplies of our product candidates, and our dependence on third party suppliers could adversely impact our business.

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We rely completely on third parties to manufacture our preclinical and clinical pharmaceutical supplies and expect to continue to rely on third parties to produce commercial supplies of any approved product candidate, and our dependence on third party suppliers could adversely impact our business.

We do not currently manufacture our product candidates and expect to rely on third parties to do so, if and when required. The proprietary yeast cell line from which the Adrulipase API is derived is kept at a storage facility maintained by Charles River Laboratories Inc. Adrulipase drug substance and drug product are currently manufactured at a contract facility located in Tianjin, China owned by Asymchem Life Science Co., Ltd. We believe there are multiple alternative contract manufacturers capable of producing the Adrulipase product we need for clinical trials. There is no guarantee that the processes are easily reproducible and transferrable.

We are completely dependent on these third parties for product supply and our Adrulipase development program would be adversely affected by a significant interruption in our ability to receive such materials. We have not yet entered into long-term manufacturing or supply agreements with any third parties. Furthermore, our third-party suppliers will be required to obtain and maintain compliance with cGMPs and will be subject to inspections by the FDA or comparable regulatory authorities in other jurisdictions to confirm such compliance. In the event that the FDA or such other authorities determine that our third-party suppliers have not complied with cGMP, our clinical trials could be terminated or subjected to a clinical hold until such time as we are able to obtain appropriate replacement material. Any delay, interruption or other issues that arise in the manufacture, packaging, or storage of our products as a result of a failure of the facilities or operations of our third-party suppliers to pass any regulatory agency inspection could significantly impair our ability to develop and commercialize our products.

We do not expect to have the resources or capacity to commercially manufacture any of our proposed products, if approved, and will likely continue to be dependent upon third party manufacturers. Our dependence on third parties to manufacture and supply us with clinical trial materials and any approved products may adversely affect our ability to develop and commercialize our products on a timely basis or at all.

We rely on third parties to conduct our clinical trials. If these third parties do not meet our deadlines or otherwise conduct the trials as required, our clinical development programs could be delayed or unsuccessful and we may not be able to obtain regulatory approval for or commercialize our product candidates when expected or at all.

We do not have the ability to conduct all aspects of our preclinical testing or clinical trials ourselves. We use contract research organizations (CROs) to conduct our clinical trials and will rely upon such CROs, as well as medical institutions, clinical investigators and consultants, to conduct our trials in accordance with our clinical protocols. Our CROs, investigators and other third parties will play a significant role in the conduct of these trials and the subsequent collection and analysis of data from the clinical trials.