▸ Any of the foregoing could harm our business and we cannot anticipate all of the ways in which the current economic climate and financial market conditions or other circumstances beyond our control could adversely impact our business.· · · · ● 1 ▸ Significant political, trade or regulatory developments, unfavorable global economic conditions, and other circumstances beyond our control, could have a material adverse effect on our business, financial condition or results of operations.· · · · ● 1 ▸ The market price of our common stock has been, and may continue to be, volatile.· · · · ● 1 ▸ We were granted fast track designation by the FDA for DISC-3405 for the treatment of PV in September 2023 and for DISC-0974 for the treatment of anemia in non-dialysis dependent chronic kidney disease in February 2024, and we may seek fast track· · · · ● 1 ▸ If we raise any additional debt financing, the terms of such additional debt could further restrict our operating and financial flexibility.· · · ● ● 2 ▸ Our existing and any future indebtedness could adversely affect our ability to operate our business.· · · ● ● 2 ▸ A public health crisis, pandemic, epidemic, or outbreak of an infectious or highly contagious disease, may materially and adversely affect our business and financial results and could cause a disruption to the development of our product candidates.· · ● ● ● 3 ▸ Changes in tax law may adversely affect us or our investors.· ● ● ● ● 4 ▸ Clinical development involves a lengthy and expensive process, with an uncertain outcome.· ● ● ● ● 4 rw ▸ Current and future healthcare reform measures may have a material adverse effect on our business and results of operations.· ● ● ● ● 4 rw ▸ If approved, our investigational products regulated as biologics may face competition from biosimilars or interchangeable products approved through an abbreviated regulatory pathway.· ● ● ● ● 4 ▸ If equity research analysts do not publish research or reports, or publish unfavorable research or reports, about us, our business or our market, our stock price and trading volume could decline.· ● ● ● ● 4 ▸ If our current product candidates or any future product candidates do not achieve broad market acceptance, the revenue that we generate from our sales may be limited, and we may never become profitable.· ● ● ● ● 4 ▸ If we are unable to adequately protect and enforce our trade secrets, our business and competitive position would be harmed.· ● ● ● ● 4 ▸ If we experience delays in obtaining, or if we fail to obtain, approval of our product candidates, the commercial prospects for our product candidates may be harmed and our ability to generate revenue will be materially impaired.· ● ● ● ● 4 ▸ If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented.· ● ● ● ● 4 ▸ If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.· ● ● ● ● 4 ▸ Intellectual property litigation and administrative patent office patent validity challenges in one or more countries could cause us to spend substantial resources and distract our personnel from their normal responsibilities.· ● ● ● ● 4 ▸ Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions.· ● ● ● ● 4 ▸ Our employees, principal investigators, CROs and consultants may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements or insider trading.· ● ● ● ● 4 ▸ Our executive officers, directors and principal stockholders have the ability to significantly influence all matters submitted to our stockholders for approval.· ● ● ● ● 4 rw ▸ Our future success depends on our ability to retain key executives and experienced scientists and to attract, retain, and motivate qualified personnel.· ● ● ● ● 4 ▸ Our future taxable income may be subject to certain limitations.· ● ● ● ● 4 ▸ Our limited operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability.· ● ● ● ● 4 ▸ Provisions in our charter documents and under Delaware law could make an acquisition of us more difficult and may discourage any takeover attempts our stockholders may consider favorable, and may lead to entrenchment of management.· ● ● ● ● 4 ▸ Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.· ● ● ● ● 4 ▸ group Risks Related to Employee Matters and Managing Growth· ● ● ● ● 4 rw ▸ Risks Related to Our Limited Operating History, Financial Position and Capital Requirements· ● ● ● ● 4 rw ▸ Risks Related to the Discovery and Development of Our Product Candidates· ● ● ● ● 4 ▸ Sales of a significant number of shares by existing stockholders could cause our stock price to decline.· ● ● ● ● 4 rw ▸ The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.· ● ● ● ● 4 ▸ The FDA, the EMA and other regulatory authorities may implement additional regulations or restrictions on the development and commercialization of our product candidates, and such changes can be difficult to predict.· ● ● ● ● 4 ▸ The third parties upon whom we rely for the supply of the active pharmaceutical ingredients used in our product candidates are our sole sources of supply, and the loss of any of these suppliers could significantly harm our business.· ● ● ● ● 4 ▸ We do not anticipate that we will pay any cash dividends in the foreseeable future.· ● ● ● ● 4 ▸ We expect to expand our development and regulatory capabilities and potentially implement sales, marketing and distribution capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.· ● ● ● ● 4 ▸ We have incurred and will continue to incur increased costs and increased demands upon management as a result of complying with the laws and regulations affecting public companies.· ● ● ● ● 4 rw ▸ We have no products approved for commercial sale and have not generated any revenue from product sales.· ● ● ● ● 4 ▸ We may incur additional costs or experience delays in initiating or completing, or ultimately be unable to complete, the development and commercialization of our product candidates.· ● ● ● ● 4 ▸ We may initiate, become a defendant in or otherwise become party to lawsuits to protect or enforce our intellectual property rights, which could be expensive, time-consuming, and unsuccessful.· ● ● ● ● 4 rw ▸ We may not obtain licenses or sublicenses to intellectual property rights in all markets on equally or sufficiently favorable terms with third parties.· ● ● ● ● 4 rw ▸ We may seek orphan drug designation for certain of our product candidates, and we may be unsuccessful or may be unable to maintain the benefits associated with orphan drug designation, including the potential for market exclusivity.· ● ● ● ● 4 ▸ We may seek priority review designation for one or more of our product candidates, but we might not receive such designation, and even if we do, such designation may not lead to a faster regulatory review or approval process.· ● ● ● ● 4 ▸ We might not realize the anticipated benefits of our current collaborations with Mabwell or NIH, or any other collaborations we enter into in the future.· ● ● ● ● 4 ▸ As of December 31, 2024, we had 84 full-time employees and no part-time employees. We expect to experience significant growth in the number of our employees and the scope of our operations, particularly as we mature as a public company and in the· · · ● · 1 ▸ Our product development programs and the potential commercialization of our product candidates will require substantial additional cash to fund expenses. For some of our product candidates, we may decide to collaborate with pharmaceutical and· · · ● · 1 ▸ The U.S. American Rescue Plan Act of 2021, which eliminates the statutory Medicaid drug rebate cap, previously set at 100% of a drug’s average manufacturer price, for single source and innovator multiple source drugs, effective January 1, 2024.· · · ● · 1 ▸ The U.S. Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. Additionally, there have been· · · ● · 1 ▸ The Right to Try Act (2018) provides a federal framework for certain patients to access certain investigational new drug products that have completed a Phase 1 clinical trial and that are undergoing investigation for FDA approval.· · ● · · 1 ▸ The U.S. American Taxpayer Relief Act of 2012 further reduced Medicare payments to several types of providers and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.· · ● ● · 2 ▸ The U.S. Budget Control Act of 2011, for example, included aggregate reductions of Medicare payments to providers of 2% per fiscal year that will remain in effect through 2031.· · ● · · 1 ▸ An active trading market for our common stock may not develop and our stockholders may not be able to resell their shares of common stock for a profit, if at all.· ● ● · · 2 ▸ Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors, which may adversely affect our future profitability.· ● ● ● · 3 ▸ Delayed access to deposits or other financial assets or the uninsured loss of deposits or other financial assets;· ● · · · 1 ▸ Potential or actual cross-defaults in other credit agreements, credit arrangements or operating or financing agreements; or· ● · · · 1 ▸ Stockholders who hold contingent value rights, or CVRs, potentially may not receive any payment on the CVRs and the CVRs may otherwise expire valueless.· ● · · · 1 ▸ Termination of cash management arrangements and/or delays in accessing or actual loss of funds subject to cash management arrangements.· ● · · · 1 ▸ Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations.· ● ● ● · 3 ▸ We will have broad discretion in the use of our cash and cash equivalents and may invest or spend our cash and cash equivalents in ways with which you do not agree and in ways that may not increase the value of your investment.· ● ● · · 2 ▸ Anti-takeover provisions contained in our charter and our by-laws, as well as provisions of Delaware law, could impair a takeover attempt.● · · · · 1 ▸ Any of the foregoing risks could have a material adverse effect on our business, financial condition and prospects.● · · · · 1 ▸ As a clinical development company, our operations have consumed substantial amounts of cash since inception.● · · · · 1 ▸ Because we have no current plans to pay cash dividends on our common stock, you may not receive any return on investment unless you sell your common stock for a price greater than that which you paid for it.● · · · · 1 ▸ CMS published a final rule that allows Medicare Advantage Plans the option of using step therapy for Part B drugs, effective January 1, 2020.● ● ● · · 3 rw ▸ Comprehensive tax reform legislation could adversely affect our business and financial condition.● · · · · 1 ▸ Even if our product candidates receive regulatory approval, they will remain subject to extensive regulatory scrutiny and may still face future development and regulatory difficulties.● · · · · 1 ▸ Even if we commercialize our product candidates, these products may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, which could harm our business.● · · · · 1 ▸ Future offerings of debt or equity securities by us may adversely affect the market price of our common stock.● · · · · 1 ▸ GEM103 and any other product candidates would need to undergo rigorous clinical trials and regulatory approvals, and success in nonclinical studies or earlier-stage clinical trials may not be indicative of results in future clinical trials.● · · · · 1 ▸ GEM103 and other product candidates for which we may choose to seek approval as biologic products may face competition sooner than anticipated.● · · · · 1 ▸ Healthcare insurance coverage and reimbursement may be limited or unavailable for our product candidates, if approved, which could make it difficult for us to sell our product candidates profitably.● · · · · 1 ▸ If disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements on acceptable terms, we may be unable to successfully develop and commercialize the affected product candidates.● · · · · 1 ▸ If the FDA becomes unable to continue its current level of performance, we could experience delays and setbacks for our product candidates and for any approvals we may seek which could adversely affect our business.● · · · · 1 ▸ If we are not successful in discovering, developing, receiving regulatory approval for and commercializing GEM103 or other product candidates, our ability to expand our business and achieve our strategic objectives would be impaired.● · · · · 1 ▸ If we are successful in completing a strategic transaction, we may be exposed to other operational and financial risks.● · · · · 1 ▸ If we do not retain key employees, our ability to maintain our ongoing operations or execute a potential strategic option could be impaired.● · · · · 1 ▸ If we fail to comply with our obligations in our current and future intellectual property licenses and funding arrangements with third parties, we could lose rights that are important to our business.● · · · · 1 ▸ Intellectual property rights do not necessarily address all potential threats.● · · · · 1 ▸ Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of● · · · · 1 ▸ On January 2, 2013, the U.S. American Taxpayer Relief Act of 2012 was signed into law, which, among other things, further reduced Medicare payments to several types of providers.● · · · · 1 ▸ Our ability to consummate a strategic transaction depends on our ability to retain our employees required to consummate such a transaction.● · · · · 1 ▸ Our ability to consummate a strategic transaction depends on our ability to retain our employees required to consummate such transaction.● · · · · 1 ▸ Our business and operations would suffer in the event of computer system failures, cyber-attacks or deficiencies in our or related parties’ cyber security.● · · · · 1 ▸ Our corporate restructuring and the associated headcount reduction may not result in anticipated savings, could result in total costs and expenses that are greater than expected and could disrupt our business.● · · · · 1 ▸ Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.● · · · · 1 ▸ Our employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.● · · · · 1 ▸ Our failure to meet the continued listing requirements of The Nasdaq Capital Market could result in a de-listing of our common stock.● · · · · 1 ▸ Our failure to obtain regulatory approval in international jurisdictions would prevent us from marketing our product candidates outside the United States.● · · · · 1 ▸ Our inability to protect our confidential information and trade secrets would harm our business and competitive position.● · · · · 1 ▸ Our issuance of additional capital stock in connection with financings, acquisitions, investments, our stock incentive plans or otherwise will dilute all other stockholders.● · · · · 1 ▸ Our product candidates may not achieve adequate market acceptance among physicians, patients, third-party payors and others in the medical community necessary for commercial success.● · · · · 1 ▸ Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.● · · · · 1 ▸ Patents that ultimately issue that cover our product candidates could be found invalid or unenforceable if challenged in court or the USPTO.● · · · · 1 ▸ 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.● · · · · 1 ▸ group Risks Related to Our Common Stock● · · · · 1 ▸ Risks Related to Strategic Alternative Process and Potential Strategic Transaction● · · · · 1 ▸ group Risks Related to our Business● · · · · 1 ▸ Risks Related to our Financial Position and Need for Additional Capital● · · · · 1 ▸ The advancement of healthcare reform may negatively impact our ability to profitably sell our product candidates, if approved.● · · · · 1 ▸ The future sales of shares by existing stockholders and future exercise of registration rights may adversely affect the market price of our common stock.● · · · · 1 ▸ The impact and results of our ongoing strategic process are uncertain and may not be successful.● · · · · 1 ▸ The manufacture of GEM103 and other product candidates requires significant expertise and capital investment, including the development of advanced manufacturing techniques and process controls. Manufacturers of these products sometimes● · · · · 1 ▸ The occurrence of any event or penalty described above may inhibit our ability to commercialize our products and generate revenue.● · · · · 1 ▸ The price of our common stock has been and may continue to be volatile and the value of an investment in our common stock may decline.● · · · · 1 ▸ There can be no assurance that we will be able to comply with the continued listing standards of Nasdaq.● · · · · 1 ▸ There may be significant delays in obtaining coverage and reimbursement for newly approved drugs and biologics, and coverage may be more limited than the purposes for which the product is approved by the FDA or applicable foreign regulatory● · · · · 1 ▸ These market and industry factors may materially reduce the market price of our common stock regardless of our operating performance.● · · · · 1 ▸ We currently have a limited operating history, have not generated any revenue to date and may never become profitable.● · · · · 1 ▸ We have been and may in the future be subject to many manufacturing risks, any of which could substantially increase our costs, delay clinical programs and limit supply of our products.● · · · · 1 ▸ We have limited experience in conducting clinical trials and have never obtained approval for any product candidates and may be unable to do so successfully.● · · · · 1 ▸ We may be at increased risk of securities class action litigation.● · · · · 1 ▸ We may be subject to claims by third parties asserting that our employees or we have misappropriated a third party’s intellectual property, or claiming ownership of what we regards as our own intellectual property.● · · · · 1 ▸ We may be unable to obtain intellectual property rights or technology necessary to develop and commercialize our product candidates.● · · · · 1 ▸ We may become involved in lawsuits or other proceedings to protect or enforce our intellectual property, which could be expensive, time-consuming and unsuccessful and have a material adverse effect on the success of our business.● · · · · 1 ▸ We may become involved in securities class action litigation that could divert management’s attention and harm the company’s business, and insurance coverage may not be sufficient to cover all costs and damages.● · · · · 1 ▸ We may continue to be heavily dependent on the success of GEM103, our lead product candidate.● · · · · 1 ▸ We may encounter difficulties in managing any future growth, which could adversely affect our operations.● · · · · 1 ▸ We may incur significant additional costs as a result of being a public company, which may adversely affect our operating results and financial condition.● · · · · 1 ▸ We may not be able to protect our intellectual property rights throughout the world.● · · · · 1 ▸ We may not be successful in identifying and implementing any strategic business combination or other transaction and any strategic transactions that we may consummate in the future could have negative consequences.● · · · · 1 ▸ We may not realize any additional value in a strategic transaction.● · · · · 1 ▸ We may seek to establish collaborations, and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development and commercialization plans.● · · · · 1 ▸ We might not be able to utilize a significant portion of our U.S. NOL carryforwards and U.S. research and development tax credit carryforwards.● · · · · 1 ▸ We use and generate materials that may expose us to material liability.● · · · · 1 ▸ Product liability lawsuits brought against us could cause us to incur substantial liabilities and could limit commercialization of any product candidates that we may develop.● · · · ● 2 rw ▸ Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our current or future product candidates.● ● ● ● ● 5 rw ▸ group Risks Related to Commercialization● ● ● ● ● 5 ▸ group Risks Related to Government Regulation● ● ● ● ● 5 ▸ group Risks Related to Our Intellectual Property● ● ● ● ● 5 rw ▸ group Risks Related to Our Reliance on Third Parties● ● ● ● ● 5 rw ▸ Should any of these events occur, they could significantly harm our business, financial condition, results of operations and prospects.● ● ● ● ● 5 rw ▸ We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.● ● ● ● ● 5 rw ▸ We have incurred significant net losses since our inception and anticipate that we will continue to incur losses for the foreseeable future.● ● ● ● ● 5 rw 
