▸ A prolonged U.S. federal government shutdown could materially and adversely affect our business, operations, and legal proceedings.· · · · ● 1 ▸ In the United States and certain non-U.S. jurisdictions, there have been, and we expect there will continue to be, a number of legislative and regulatory changes and proposed changes regarding the healthcare system that could, among other things,· · · · ● 1 ▸ Our manufacturing capabilities could be affected by cost-overruns, resource constraints, unexpected delays, equipment failures, labor shortages or disputes, natural disasters, power failures and numerous other factors that could prevent us from· · · · ● 1 ▸ Patent applications may be denied or issued patents covering our products and product candidates could be found invalid or unenforceable.· · · · ● 1 ▸ The U.S. government may have march-in rights with respect to certain of our intellectual property, which could limit our ability to exclusively commercialize products developed with government funding.· · · · ● 1 ▸ The regulatory pathway for approval of biosimilars or interchangeable biologics to our products is uncertain, which may create competitive risks.· · · · ● 1 ▸ Unfavorable global economic conditions and government regulations could adversely affect our business, financial condition or results of operations.· · · · ● 1 ▸ We face particular risks that current or former employees, consultants, or collaborators who have knowledge of our proprietary methods and techniques could join competitors or form competing enterprises and use that knowledge to replicate· · · · ● 1 ▸ We may be unable to protect the confidentiality of our trade secrets and know-how.· · · · ● 1 ▸ Our ability to use our net operating losses to offset future taxable income may be subject to certain limitations.· · · ● ● 2 ▸ Tariffs could adversely affect our business and financial results.· · · ● ● 2 ▸ See Item 1C. “Cybersecurity”, of this Annual Report for more information.· · ● ● ● 3 rw ▸ There can be no assurance that we will be able to comply with the continued listing standards of Nasdaq.· · ● ● ● 3 ▸ We are subject to manufacturing risks that could substantially increase the costs and limit supply of product candidates or prevent us from achieving a commercially viable production process.· ● · ● ● 3 ▸ As is the case with other biopharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing patents in the biopharmaceutical industry involve both technological and legal complexity,· · · ● · 1 ▸ Our expenses could increase beyond expectations for a variety of reasons, including due to our growth strategy and the increase in the scope and complexity of our operations. In executing our strategy and plans to invest in enhancing and scaling· · · ● · 1 ▸ Our independent registered public accounting firm has included an explanatory paragraph relating to our ability to continue as a going concern in its report on our audited financial statements.· · · ● · 1 ▸ Our independent registered public accounting firm is not required to formally attest to the effectiveness of our internal control over financial reporting until after we are no longer an “emerging growth company” as defined in the JOBS Act. At such· · · ● · 1 ▸ Our success depends largely on the skills, experience and reputation of certain key management and personnel, in particular our directors, executive officers and senior scientific staff. The loss or unavailability of any of these individuals for any· · · ● · 1 ▸ Tariffs could adversely affect our business financial results.· · · ● · 1 ▸ We previously identified a material weakness in our internal control over financial reporting, which was subsequently remediated during the year ended December 31, 2024.· · · ● · 1 ▸ Our current and future relationships with customers and third party payors in the United States and elsewhere may be subject, directly or indirectly, to applicable anti-kickback, fraud and abuse, false claims, transparency,· · ● · · 1 ▸ Our long-term growth strategy to develop and market additional products and product candidates is heavily dependent on precise, accurate and reliable scientific data to identify, select and develop promising pharmaceutical product candidates and· · ● · · 1 ▸ Changes in tax laws and regulations or exposure to additional tax liabilities could adversely affect our financial results.· ● · · · 1 ▸ Our ability to continue to operate as a going concern depends on our ability to obtain adequate financing in the future.· ● · ● · 2 ▸ Our failure to meet the continuing listing requirements of Nasdaq could result in a de-listing of our securities.· ● · · · 1 ▸ We have historically relied on awards from, and contracts with, the U.S. Government to fund our business and operations, and will need to find new and alternative sources of funding following the discontinuance of certain such arrangements.· ● · · · 1 ▸ We may, now or in the future, be required to reimburse our counterparties in connection with costs incurred during performance of our contractual arrangements.· ● · · · 1 ▸ Insiders have substantial influence over the Company, which could limit your ability to affect the outcome of key transactions, including a change of control.● · · · · 1 ▸ Our product candidates are in preclinical or early-stage clinical development.● · · · · 1 ▸ Regulatory approval for the genetic modification of animals, including those from which antibodies are● · · · · 1 ▸ group Risks Related to Financing and Tax● ● · · · 2 ▸ Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and stock price.● ● · · · 2 ▸ We are party to a contracting agreement with the US federal government which could be subject to revision or termination at the discretion of the US federal government.● · · · · 1 ▸ We may redeem your unexpired warrants prior to their exercise at a time that is disadvantageous to you, thereby making your warrants worthless.● · · · · 1 ▸ We may require additional capital to support business growth, and this capital might not be available on acceptable terms, if at all.● ● · · · 2 ▸ A decreased ability to issue additional securities or obtain additional financing in the future.● · ● ● ● 4 ▸ group A limited amount of analyst coverage; and● · ● ● ● 4 ▸ We depend upon senior management and senior scientific staff, and their loss or unavailability could put us at a competitive disadvantage.● · ● ● ● 4 ▸ An investment in our common stock is extremely speculative and there can be no assurance of any return on any such investment.● ● ● ● ● 5 ▸ Anti-takeover provisions contained in our certificate of incorporation as well as provisions of Delaware law, could impair a takeover attempt.● ● ● ● ● 5 ▸ Because we have no current plans to pay cash dividends on our common stock for the foreseeable future, investors may not receive any return on their investment unless they sell their common stock for a price greater than the price paid.● ● ● ● ● 5 rw ▸ Changes in accounting principles may cause previously unanticipated fluctuations in our financial results, and the implementation of such changes may impact our ability to meet our financial reporting obligations.● ● ● ● ● 5 ▸ Changes in legislation in U.S. and foreign taxation of international business activities or the adoption of other tax reform policies, as well as the application of such laws, could adversely impact our financial position and operating results.● ● ● ● ● 5 ▸ Changes in methods of product candidate manufacturing or formulation may result in additional costs or delays.● ● ● ● ● 5 ▸ Changes in patent law in the United States and in ex-U.S. jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.● ● ● ● ● 5 ▸ Current and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize any product candidates we or our collaborators develop and may adversely affect the prices for such product candidates.● ● ● ● ● 5 ▸ Even if we obtain regulatory approval for our product candidates, our products will remain subject to regulatory scrutiny.● ● ● ● ● 5 rw ▸ Extreme factors or forces beyond our control could negatively impact our business.● ● ● ● ● 5 ▸ Failure to successfully identify, develop and commercialize additional products or product candidates could impair our ability to grow.● ● ● ● ● 5 ▸ Future sales and issuances of our common stock or rights to purchase common stock, including pursuant to our equity plans, could result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall.● ● ● ● ● 5 ▸ If our estimates or judgments relating to our critical accounting policies prove to be incorrect, our business, financial condition, and results of operations could be adversely affected.● ● ● ● ● 5 ▸ If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.● ● ● ● ● 5 ▸ If patent laws or the interpretation of patent laws change, our competitors may be able to develop and commercialize our discoveries.● ● ● ● ● 5 ▸ If securities or industry analysts do not publish research or reports about our business or publish negative reports, the market price of our common stock could decline.● ● ● ● ● 5 ▸ If we are unable to develop our sales, marketing and distribution capability on our own or through collaborations with marketing partners, we will not be successful in commercializing our product candidates.● ● ● ● ● 5 ▸ If we do not establish sales and marketing capabilities successfully, either on our own or in collaboration with third parties, we will not be successful in commercializing our product candidates.● ● ● ● ● 5 ▸ If we do not obtain patent term extension and data exclusivity for any product candidates we may develop, our business may be materially harmed.● ● ● ● ● 5 ▸ If we encounter difficulties enrolling patients in clinical trials, clinical trials of our product candidates may be delayed or otherwise adversely affected.● ● ● ● ● 5 ▸ If we fail to achieve announced milestones in the timeframes we expect, the development and commercialization of our product candidates may be delayed, and our business and results of operations may be harmed.● ● ● ● ● 5 ▸ If we fail to maintain an effective system of disclosure controls and internal control over financial reporting, our ability to produce timely and accurate financial statements or comply with applicable regulations could be impaired.● ● ● ● ● 5 ▸ If we fail to successfully operate our animal production facility, it may adversely affect our clinical trials and the commercial viability of our product candidates.● ● ● ● ● 5 ▸ Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.● ● ● ● ● 5 ▸ Our limited operating history makes future forecasting difficult.● ● ● ● ● 5 ▸ Our product candidates are uniquely manufactured, and we may encounter difficulties in production, particularly with respect to scaling our manufacturing capabilities.● ● ● ● ● 5 rw ▸ Our success depends on our ability to maintain the proprietary nature of our technology.● ● ● ● ● 5 ▸ Our warrants are accounted for as liabilities and changes in value of the warrants could have a material effect on our financial results.● ● ● ● ● 5 ▸ Outbreaks of livestock diseases and other events affecting the health of our bovine herd can adversely impact our ability to conduct our operations and production of our product candidates.● ● ● ● ● 5 ▸ Product liability lawsuits against us or any of our future collaborators could divert our resources and attention, cause us to incur substantial liabilities and limit commercialization of our product candidates.● ● ● ● ● 5 ▸ Regulatory approval for any approved product is limited by the FDA to those specific indications and conditions for which clinical safety and efficacy have been demonstrated.● ● ● ● ● 5 ▸ Reports published by analysts, including projections in those reports that differ from our actual results, could adversely affect the price and trading volume of our common stock.● ● ● ● ● 5 ▸ group Risks Related to Being a Public Company● ● ● ● ● 5 ▸ group Risks Related to Capital Markets● ● ● ● ● 5 ▸ group Risks Related to Our Business and Operations● ● ● ● ● 5 ▸ group Risks Related to Our Intellectual Property● ● ● ● ● 5 ▸ group Risks Related to our Common Stock● ● ● ● ● 5 ▸ Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall.● ● ● ● ● 5 ▸ The FDA or comparable foreign regulatory authorities may disagree with our regulatory plan for our product candidates.● ● ● ● ● 5 ▸ The future commercial success of our product candidates will depend on the degree of market acceptance of our potential products among physicians, patients, healthcare payers, and the medical community.● ● ● ● ● 5 ▸ The manufacturing facilities in which our product candidates are made could be adversely affected by equipment failures, labor shortages, natural disasters, power failures and numerous other factors.● ● ● ● ● 5 ▸ The manufacturing process used to produce Tc Bovine is novel and has not been validated for commercial production.● ● ● ● ● 5 ▸ The market price of our securities may be volatile, which could cause the value of any investment in our securities to decline.● ● ● ● ● 5 ▸ The regulatory approval processes of the FDA are lengthy, time-consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed.● ● ● ● ● 5 rw ▸ The successful development of pharmaceutical products is highly uncertain.● ● ● ● ● 5 ▸ Third parties may claim we infringe their intellectual property rights.● ● ● ● ● 5 ▸ We anticipate adding new employees and we will have to integrate such new employees into our operations.● ● ● ● ● 5 ▸ We are an “emerging growth company,” and our election to comply with the reduced disclosure requirements as a public company may make our common stock less attractive to investors.● ● ● ● ● 5 rw ▸ We are limited in our ability to manufacture pharmaceutical products.● ● ● ● ● 5 ▸ We are subject to stringent environmental regulation and potentially subject to environmental litigation, proceedings, and investigations.● ● ● ● ● 5 ▸ We depend on our senior management and senior scientific staff, and their loss or unavailability could put us at a competitive disadvantage.● ● ● ● ● 5 rw ▸ We have no sales and marketing experience.● ● ● ● ● 5 ▸ We have not entered into long term manufacturing and supply agreements with any producers.● ● ● ● ● 5 rw ▸ We have third party collaborators that might claim rights in or to our technology and/or assets.● ● ● ● ● 5 ▸ We incur increased costs and demands upon management as a result of complying with the laws and regulations affecting public companies, which could adversely affect our business, financial condition, and results of operations.● ● ● ● ● 5 ▸ We intend to rely on third parties to produce commercial supplies of our product candidates.● ● ● ● ● 5 ▸ We may be subject to securities litigation, which is expensive and could divert management attention.● ● ● ● ● 5 ▸ We may become involved in litigation to protect or enforce our patents or the patents of our collaborators or licensors, which could be expensive and time-consuming.● ● ● ● ● 5 ▸ We may incur unexpected costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.● ● ● ● ● 5 ▸ We may not be able to protect our intellectual property rights throughout the world.● ● ● ● ● 5 ▸ We must attract and retain highly skilled personnel and strategic partners, and we may be unable to effectively manage our growth with our limited resources.● ● ● ● ● 5 rw ▸ We operate in a highly competitive industry.● ● ● ● ● 5 
