NASDAQ: GRDX

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:

●A majority of Gris AI Corp.’s projected 2026 revenues are expected to be derived from the AI data center technology.

●The contribution from this platform is expected to increase substantially in subsequent years.

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:

●completion of preclinical laboratory studies, animal studies and other supporting data, generally in accordance with good laboratory practice, or GLP, requirements

●submission to the FDA of an investigational new drug application, or IND, which must become effective before human clinical trials may begin

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●approval by an independent institutional review board, or IRB, or ethics committee for each clinical site before a clinical trial may begin

●performance of adequate and well-controlled human clinical trials to establish safety and efficacy, or, in the case of a biologic, safety, purity and potency, for each proposed indication

●preparation and submission to the FDA of a marketing application, generally a new drug application, or NDA, or biologics license application, or BLA

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

●satisfactory completion of FDA inspections of manufacturing facilities and, where applicable, clinical sites

●FDA review and approval of the NDA or BLA prior to any commercial marketing or sale in the United States.

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

●regulations applicable to aggregators, distributed energy resources, demand response and ancillary services participation

●electrical, communications, device integration and installation standards

●software, cloud, cybersecurity and critical infrastructure requirements

●data privacy, data security and consumer protection laws

●commercial contracting requirements with utilities, retailers, partners and customers

●export controls, sanctions and anti-corruption laws where international operations or counterparties are involved.

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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