CNTN

Risk Factors— Risks Related to Our CC Strategy and Holdings — We face risks relating to the custody of our CC tokens, including the loss or destruction of private keys required to access our CC tokens and cyberattacks or other data loss relating to our CC tokens, including smart contract related losses and vulnerabilities.” Our Therapeutic Candidate Developments Through our subsidiary Gravitas, we develop therapeutic candidates in immunology and inflammation with high unmet need.
Our Product Pipeline GV GV104 (formerly TH104) is a proprietary buccal film formulation of nalmefene, a long-acting opioid antagonist, being developed for prophylactic protection against synthetic opioid exposure in military and first responder populations.
GV104 is a buccal film containing 16 mg of nalmefene, designed for rapid absorption through the oral mucosa.
The film is approximately the size of a dime, enabling discreet and convenient administration without water or injection equipment.
Buccal delivery bypasses hepatic first-pass metabolism, resulting in higher bioavailability compared to oral administration.
Nalmefene is a 6-methylene derivative of naltrexone with pharmacological properties that address the limitations of naloxone.
In a head-to-head clinical study comparing intramuscular nalmefene to intramuscular and intranasal naloxone for reversal of fentanyl-induced respiratory depression, nalmefene demonstrated a plasma half-life of 8 to 11 hours compared to 30 to 90 minutes for naloxone, and mu-opioid receptor binding affinity approximately 3.6 to 5.4 times higher than naloxone. 3 In this study, nalmefene achieved faster onset, greater magnitude, and longer duration of respiratory depression reversal, with 100% of subjects achieving respiratory recovery compared to 60-80% for naloxone formulations. 4 We are pursuing FDA approval through the 505(b)(2) regulatory pathway, which permits reliance on the FDA’s prior findings of safety and effectiveness for REVEX (nalmefene hydrochloride injection), which was approved by the FDA in 1995 and determined by the FDA in November 2017 to not have been withdrawn from sale for reasons of safety or effectiveness. 5 Following a Type C meeting with the FDA in March 2025, we confirmed that no additional clinical trials are required to support our NDA submission.
We anticipate initiating a rolling NDA submission in the first half of 2027, with FDA approval anticipated in the first half of 2028.
GV023 GV023 (formerly TH023), is an oral anti-tumor necrosis factor-alpha (TNF-α) monoclonal antibody, infliximab.
On September 11, 2024, we entered into a Patent License Agreement (the “Intract Agreement”) with Intract Pharma Limited (“Intract”), pursuant to which, we exclusively licensed GV023.
Infliximab is a purified recombinant DNA-derived chimeric IgG monoclonal antibody protein that contains both murine and human components that inhibit tumor TNF-a.
Under the terms of the Intract Agreement, we licensed global development and commercialization rights (outside of South Korea) to Intract’s Soteria® and Phloral® delivery platform along with an existing supply agreement for infliximab to be used in the oral product development program.
Cipriano A, Apseloff G, Kapil RP, He E, Shet M, Harris SC.
Time Course of Reversal of Fentanyl-Induced Respiratory Depression in Healthy Subjects by Intramuscular Nalmefene and Intramuscular and Intranasal Naloxone.
Nalmefene: A Long-Acting Opioid Antagonist.
Clinical Applications in Emergency Medicine.
Determination That REVEX (Nalmefene Hydrochloride Injection) Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness.
Federal Register. 2017;82(212):51051-51052.
GV023, an oral formulation of infliximab, addresses a critical limitation of the IV gold standard by eliminating the treatment burden of repeated intravenous infusions.
By enabling patient self-administration, an oral TNF-alpha inhibitor may potentially improve medication adherence and persistence while expanding treatment access to patients who currently defer IV therapy due to infusion center barriers, needle anxiety, or lifestyle constraints.
Company Developments In the fourth quarter of 2025 and into early 2026, the Company completed a series of significant financing transactions and related strategic initiatives designed to fund its digital asset treasury and CC treasury strategy, validator operations and related activities.
November 2025 PIPE In November 2025, the Company completed a private placement offering with accredited investors providing for a private investment in public equity transaction, consisting of (i) the sale of an aggregate of 25,966,048 shares of common stock and cash pre-funded warrants (the “Cash Offering”) and (ii) the issuance of cryptocurrency pre-funded warrants in exchange for CC (the “Cryptocurrency Offering”) contributed by participating investors.
We raised in aggregate gross proceeds of approximately $545 million before fees and expenses.
Under the terms of the offering, a limited portion of available cash was designated for legacy operating expenses and existing management compensation, with the balance of proceeds allocated to transaction expenses and the acquisition of CC and implementation of the Company’s CC treasury and validator strategy.
January 2026 Offering Subsequently, on January 20, 2026, the Company entered into an underwriting agreement with Clear Street LLC, as sole underwriter, for an underwritten registered direct offering to a single institutional investor consisting of 1,800,000 shares of common stock and pre-funded warrants to purchase up to 17,000,000 additional shares at a per share offering price of $2.9200 (less $0.0001 per pre-funded warrant share).
The Company announced the closing of this offering for gross proceeds of approximately $54.9 million on January 22, 2026.
Collectively, these financings and governance actions were undertaken to strengthen the Company’s capital base and support execution of its revised treasury and network participation strategy.
ATM Program Concurrently with the closing of the PIPE Transaction, on November 6, 2025, the Company entered into an at-the-market sales agreement (the “Original Sales Agreement”) with Clear Street LLC (“Clear Street”) and President Street Global, LLC (“President Street”) providing for the offer and sale of shares of its common stock having an aggregate offering price of up to $64,910,161 from time to time under Rule 415 under the Securities Act.
On December 3, 2025, President Street provided a notice pursuant to the Sales Agreement to terminate its role as a sales agent, and Clear Street became the sole sales agent.
On March 3, 2026, the Company entered into an amended and restated sales agreement (the “Sales Agreement”), with Clear Street and Virtu Americas LLC (“Virtu”, and together with Clear Street, the “Sales Agents”), relating to the sale of shares of the Company’s common stock.
The Sales Agreement amends and restates the Original Sales Agreement.
Pursuant to the Sales Agreement, the aggregate gross sales price of Common Stock available for issuance under the Sales Agreement is $300,000,000, and such amount excludes the Common Stock previously sold under the Original Sales Agreement.
Management Changes In connection with the adoption of the Company’s Digital Asset Treasury Strategy, Sireesh Appajosyula resigned as Chief Executive Officer, effective November 6, 2025.
The Board of Directors (the “Board”) appointed Mark Wendland as Chief Executive Officer and Mark Toomey as President, effective the same date.
Also on November 6, 2025, Nancy Davis and Sanam Parikh resigned as members of the Board, and Mr.
On December 10, 2025, the Board appointed Jacob Asbury as Chief Financial Officer, and Mr.
Appajosyula resigned as Interim Chief Financial Officer, continuing his service as a director and as Chief Executive Officer of Gravitas Life Sciences, Inc., a subsidiary of the Company.
At the shareholders meeting held on January 30, 2026, shareholders approved the election of Jill Sommers and William Wiley, to serve as directors.
Concurrently with the election of these two director nominees, James Gordon Liddy resigned from the Board.
On February 5, 2026, the Board appointed Angela Dominy Radkowski as Chief Operating Officer, Vincent LoPriore stepped down as Chairman and Mark Wendland was elected as the new Chairman.

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Gone since FY2024

Risks Related to Our Financial Position and Need for Additional Capital We have a limited operating history, which may make it difficult to evaluate our current business and predict our future performance.
We are a clinical-stage biopharmaceutical company with a limited operating history upon which you can evaluate our business and prospects.
We commenced operations in 2017, have no products approved for commercial sale and have not generated any revenue.
Drug development is a highly uncertain undertaking and involves a substantial degree of risk.
Since our inception, we have spent the first three years developing and refining our technology, and since 2019, we have focused our efforts on advancing the development of our product candidate, HSB-1216, which we recently deprioritized, as well as HS3215, HS0059 and HS1940.
In November 2023, we entered into the Avior Patent License Agreement for a clinical-stage asset, TH104, and TH103, a compound which we intend to potentially file an IND for.
We have not yet commenced human clinical trials for any of our product candidates, nor have we demonstrated an ability to initiate or successfully complete any large-scale or pivotal clinical trials, obtain marketing approvals, manufacture a commercial-scale product or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful product commercialization.
As a result, it may be more difficult for you to accurately predict our likelihood of success and viability than it could be if we had a longer operating history.
We plan to initiate a hepatic impairment study in 2025 prior to starting the Phase 2 clinical trial in TH104.
In addition, we intend to submit INDs to the FDA for our early-stage pre-clinical programs to gain approval to initiate clinical studies in 2025 for both HS3215 and HS1940; however, no assurance can be provided that our Phase 2 trial will be completed or that our INDs will be accepted by the FDA based on our anticipated timeline, if at all.
Our early-stage programs are in pre-clinical discovery and research stages.
As a result, we expect that it will take several years, if ever, before we have a commercialized product and generate revenue from product sales.
Even if we succeed in receiving marketing approval for and commercializing one or more of our product candidates, we expect that we will continue to incur substantial research and development and other expenses in order to discover, develop and market additional potential products.
Finding appropriate biomarkers for our potential drug candidates could limit our commercialization prospects and cause our losses to continue.
Any biomarker discovery or drug development that we are conducting may not be successful in identifying biomarkers that have commercial value for our products or therapeutic utility.
Platforms may initially show promise in identifying potential biomarkers for our drug candidates, yet fail to stratify patients for clinical development or commercialization for a number of reasons, including, but not limited to: ● research programs to identify new biomarkers will require substantial technical, financial and human resources, and we may be unsuccessful in our efforts to identify biomarkers.
If we are unable to identify suitable biomarkers for pre-clinical and clinical development, our ability to stratify patients could be compromised, which could result in significant harm to our financial position and adversely impact our stock price; ● identified biomarkers may not demonstrate correlation to efficacy, safety or tolerability; ● available data that seeks to correlate genomic or biomarker signatures with certain diseases may be influenced by the race of the patient which may limit the efficacy of our drug candidates; ● the regulatory pathway for the biomarkers may be too complex, expensive or otherwise difficult to navigate successfully; and ● competitors may develop alternative approaches that render our potential biomarkers non-competitive or less attractive.
We expect to continue to incur losses for the foreseeable future, and we expect these losses to increase as we continue our development of, and seek regulatory approvals for, our product candidates, and begin to commercialize approved drugs, if any.
Typically, it takes many years to develop a new drug from the time it is discovered to when it is available for treating patients.
We may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may increase our expenses and adversely affect our ability to generate revenue.
The size of our future net losses will depend, in part, on our ability to manage these aspects of our business.
We have incurred significant losses since inception, we expect to incur losses in the future and we may not be able to generate sufficient revenue to achieve and maintain profitability.
For the years ended December 31, 2024 and 2023 we reported a net loss of $12.2 million and $9.3 million, respectively.
As of December 31, 2024, we had an accumulated deficit of $36.9 million.
Our ability to generate revenue and achieve profitability depends significantly on our ability to achieve several milestones relating to the discovery, development and commercialization of our product candidates.
Our financial condition and operating results have varied significantly in the past and are expected to continue to fluctuate significantly due to a variety of factors, many of which are beyond our control.
Factors relating to our business that may contribute to these fluctuations include: ● our ability to continue our current research and development programs, including conducting laboratory, pre-clinical studies for product candidates; ● our ability to initiate clinical trials for product candidates; ● the success of our clinical trials through all phases of clinical development; ● delays in the commencement, enrollment and timing of clinical trials; ● our ability to secure and maintain collaborations, licensing or other arrangements for the future development and/or commercialization of our product candidates, as well as the terms of those arrangements; ● our ability to obtain, as well as the timeliness of obtaining, additional funding to develop our product candidates; ● the results of clinical trials or marketing applications for product candidates that may compete with our product candidates; ● competition from existing products or new products that may receive marketing approval; ● potential side effects of our product candidates that could delay or prevent approval or cause an approved drug to be taken off the market; ● any delays in regulatory review and approval of our product candidates; ● our ability to identify and develop additional product candidates; ● the ability of patients or healthcare providers to obtain coverage or sufficient reimbursement for our products; ● our ability, and the ability of third parties such as Clinical Research Organizations (“CROs”) to adhere to clinical study and other regulatory requirements; ● the ability of third-party manufacturers to manufacture our product candidates and key ingredients needed to conduct clinical trials and, if approved, successfully commercialize our products; ● the costs to us, and our ability as well as the ability of any third-party collaborators, to obtain, maintain and protect our intellectual property rights; ● costs related to and outcomes of potential intellectual property litigation; ● our ability to adequately support future growth; ● our ability to attract and retain key personnel to manage our business effectively; and ● our ability to build our finance infrastructure and, to the extent required, improve our accounting systems and controls.
Developing new products and services is a speculative and risky endeavor.
Products or services that initially show promise may fail to achieve the desired results or may not achieve acceptable levels of analytical accuracy or clinical utility.
We may need to alter our products in development and repeat clinical studies before we identify a potentially successful product or service.
Product development is expensive, may take years to complete and can have uncertain outcomes.
Failure can occur at any stage of the development.
If, after development, a product or service appears successful, we may, depending on the nature of the product or service, still need to obtain FDA and other regulatory clearances, authorizations or approvals before we can market it.
The FDA’s clearance, authorization or approval pathways are likely to involve significant time, as well as additional research, development and clinical study expenditures.
The FDA may not clear, authorize or approve any future product or service we develop.
Even if we develop a product or service that receives regulatory clearance, authorization or approval, we would need to commit substantial resources to commercialize, sell and market it before it could be profitable, and the product or service may never be commercially successful.
Additionally, development of any product or service may be disrupted or made less viable by the development of competing products or services.
New potential products and services may fail any stage of development or commercialization and if we determine that any of our current or future products or services are unlikely to succeed, we may abandon them without any return on our investment.
If we are unsuccessful in developing additional products or services, our potential for growth may be impaired.
In cases where we are successful in obtaining regulatory approval to market one or more of our drug candidates, our revenue will be dependent, in part, upon the size of the markets in the territories for which we gain regulatory approval, the accepted price for the product, the ability to obtain coverage and reimbursement, and whether we own the commercial rights for that territory.

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Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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