▸ Compliance with the PRC’s laws, regulations and guidelines relating to data security, cybersecurity and privacy and any other future laws and regulations may entail significant expenses and could affect our business.· · · · · ● 1 ▸ During the pendency of the Merger, we may not be able to enter into a business combination with another party and will be subject to contractual limitations on certain actions because of restrictions in the Merger Agreement.· · · · · ● 1 ▸ Failure to complete the Merger could negatively affect the value of our common stock and our future business and financial results.· · · · · ● 1 ▸ If adverse changes occur but we and Cullgen must still complete the Merger, the market price of our common stock may suffer.· · · · · ● 1 ▸ If the Merger is not completed, the market price of our common stock and our business and financial results could be materially affected.· · · · · ● 1 ▸ Our current and prospective employees could experience uncertainty about their future roles, and this uncertainty might adversely affect our ability to retain, recruit and motivate key personnel;· · · · · ● 1 ▸ Our directors and officers may have interests in the Merger that are different from, or in addition to, those of our stockholders generally that may influence them to support or approve the Merger.· · · · · ● 1 ▸ group Risks Related to the Merger with Cullgen· · · · · ● 1 ▸ Should they occur, any of these matters could adversely affect our business, or harm our financial condition, results of operations or business prospects.· · · · · ● 1 ▸ The Exchange Ratio is not adjustable based on the market price of our common stock, so the Merger consideration at the Closing may have a greater or lesser value than at the time the Merger Agreement was signed.· · · · · ● 1 ▸ The Merger may be completed even though material adverse changes may result from the announcement of the Merger, industry-wide changes or other causes.· · · · · ● 1 ▸ The issuance, or expected issuance, of our common stock in connection with the Merger could decrease the market price of our common stock.· · · · · ● 1 ▸ We are expected to incur substantial expenses related to the Merger with Cullgen.· · · · · ● 1 ▸ We are substantially dependent on our remaining employees, key contractors and consultants to facilitate the consummation of the Merger.· · · · · ● 1 ▸ If we fail to maintain proper and effective internal controls over financial reporting our ability to produce accurate and timely financial statements could be impaired.· · · · ● ● 2 ▸ Remediation measures to remediate a material weakness or significant deficiency may be time consuming, may result in us incurring significant costs, and may place significant demands on our financial and operational resources.· · · · ● ● 2 ▸ The PRC government may exert influence over Gyre Pharmaceuticals’ operations, which could result in an adverse change in our operations.· · · · ● ● 2 rw ▸ The market price of our common stock has been, and may continue to be, volatile.· · · · ● ● 2 ▸ All material aspects of research, development, manufacturing and commercialization of our products, ETUARY®, Etorel® and Contiva®, which are approved and commercialized by us in the PRC, and product candidates are heavily regulated.· · · ● ● ● 3 rw ▸ Because we rely on a limited number of suppliers for certain of our raw materials, we may experience supply interruptions that could harm our ability to manufacture products.· · · ● ● ● 3 ▸ Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.· · · ● ● ● 3 ▸ Changes in U.S. and PRC regulations may impact our business, our operating results and our ability to raise capital.· · · ● ● ● 3 ▸ Changes in patent law could diminish the value of patents generally, which may impair our ability to protect ETUARY®, Etorel®, Contiva® and our product candidate pipeline.· · · ● ● ● 3 rw ▸ Changes in tax laws or in their implementation may adversely affect our business and financial condition.· · · ● ● ● 3 ▸ Changes in the relations between the PRC and the United States may affect our business, financial condition and results of operations.· · · ● ● ● 3 rw ▸ Consequentially, any delays in completing our clinical trials may increase our costs, delay our product candidate development and approval process, and jeopardize our ability to commercialize our approved products and generate revenues.· · · ● ● ● 3 ▸ Failure to maintain optimal inventory levels could increase our operating costs or lead to unfulfilled customer orders.· · · ● ● ● 3 ▸ Fluctuations in exchange rates may result in foreign currency exchange losses.· · · ● ● ● 3 ▸ Fluctuations in prices of our raw materials and energy supply, as well as other costs associated with our production processes, may have a material adverse effect on us if we are not able to pass the cost increases on to our customers.· · · ● ● ● 3 ▸ 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.· · · ● ● ● 3 ▸ If our intangible assets are impaired, our results of operations and financial condition may be adversely affected.· · · ● ● ● 3 ▸ Implementation of the labor laws and regulations in the PRC may adversely affect our business and results of operations, and failure to fully comply with PRC labor-related laws may expose us to potential liabilities and penalties.· · · ● ● ● 3 ▸ In conducting drug research and development, we face potential liabilities; in particular, product liability claims or lawsuits that could cause us to incur substantial liabilities.· · · ● ● ● 3 ▸ Increased labor costs negatively affect our operations and have an adverse impact on our profitability.· · · ● ● ● 3 ▸ Intellectual property rights may not address all potential threats to our business or competitive advantage.· · · ● ● ● 3 ▸ Our ability to utilize our net operating loss carryforwards and tax credit carryforwards may be subject to limitations.· · · ● ● ● 3 ▸ Our executive officers, directors and principal stockholders have the ability to control or significantly influence all matters submitted to our stockholders for approval.· · · ● ● ● 3 ▸ Our failure to obtain or renew certain approvals, licenses, permits and certificates required for our business may materially and adversely affect our business, financial condition and results of operations.· · · ● ● ● 3 ▸ Our five largest customers accounted for a substantial amount of our revenue during the years ended December 31, 2025 and 2024, which subjects us to concentration risks.· · · ● ● ● 3 rw ▸ Our ongoing success is reliant on our capacity to retain key executives and to recruit, maintain, and inspire skilled professionals.· · · ● ● ● 3 ▸ Our operations are subject to and may be affected by changes in PRC tax laws and regulations.· · · ● ● ● 3 ▸ Our rights to develop and commercialize some of our product candidates are subject, in part, to the terms and conditions of licenses granted to us by others.· · · ● ● ● 3 rw ▸ PRC regulations relating to the establishment of offshore special purpose companies by residents in the PRC may subject our PRC resident beneficial owners in the PRC to liability or penalties, or may otherwise adversely affect us.· · · ● ● ● 3 ▸ group Risks Related to Our Business Operations in the PRC· · · ● ● ● 3 ▸ Should any of these events occur, they could have a material adverse effect on our business, financial condition, results of operations and prospects.· · · ● ● ● 3 ▸ The pharmaceutical industry in the PRC is highly regulated and such regulations are subject to change, which may affect approval and commercialization of our products, ETUARY®, Etorel® and Contiva®, and product candidates.· · · ● ● ● 3 rw ▸ There are uncertainties regarding the interpretation and enforcement of PRC laws, rules and regulations.· · · ● ● ● 3 ▸ Under Article 2 of the PRC Enterprise Income Tax Law, a resident enterprise is an enterprise that is established within the territory of the PRC or an enterprise established with a “de facto management body” within the PRC.· · · ● ● ● 3 ▸ We do not anticipate that we will pay any cash dividends in the foreseeable future.· · · ● ● ● 3 ▸ We have historically received government grants and have been entitled to preferential tax treatment, but we may not continue to receive government financial incentives in the future.· · · ● ● ● 3 ▸ We have limited insurance coverage, and any claims beyond our insurance coverage may result in substantial costs and a diversion of resources.· · · ● ● ● 3 ▸ We may be exposed to increased litigation, including stockholder litigation, which could have an adverse effect on our business and operations.· · · ● ● ● 3 ▸ We may be restricted from transferring our scientific data abroad or using human genetic resources collected in the PRC.· · · ● ● ● 3 ▸ We may be subject to credit risk in collecting trade receivables due from our customers.· · · ● ● ● 3 ▸ We may be subject to product liability claims that could expose us to costs and liabilities.· · · ● ● ● 3 ▸ We may be unable to conduct effective academic marketing.· · · ● ● ● 3 ▸ We may be unable to demonstrate to the satisfaction of the NMPA, FDA or comparable foreign regulatory authorities that a product candidate is safe and effective for its proposed indication;· · · ● ● ● 3 ▸ We may be unable to identify, discover, or develop new product candidates, or to identify additional therapeutic opportunities for our product candidates, in order to expand or maintain our product pipeline.· · · ● ● ● 3 ▸ We may experience substantial disruption to our production sites and problems in manufacturing our products, ETUARY®, Etorel® and Contiva®, which are approved and commercialized by us in the PRC, and future products, if approved.· · · ● ● ● 3 rw ▸ We may face risk regarding the obsolescence of our inventories.· · · ● ● ● 3 ▸ We may fail to maintain a qualified sales and marketing force.· · · ● ● ● 3 ▸ We may fail to protect our trademarks and trade names, which may negatively affect our ability to build brand recognition in our markets of interest.· · · ● ● ● 3 ▸ We may fail to sufficiently and promptly respond to clinical demand and market changes in the pharmaceutical industry.· · · ● ● ● 3 ▸ We may fail to win bids to sell our commercialized products, ETUARY®, and any other future products, if approved and commercialized, to PRC public hospitals through the centralized tender process.· · · ● ● ● 3 rw ▸ You may have difficulty enforcing judgments obtained against us.· · · ● ● ● 3 ▸ Certain provisions of the Merger Agreement may discourage third parties from submitting competing proposals, including proposals that may be superior to the arrangements contemplated by the Merger Agreement.· · ● · · ● 2 rw ▸ Preliminary, “top-line” or interim data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures.· · ● ● ● ● 4 rw ▸ Breakthrough Therapy designation by the FDA for any product candidate may not lead to a faster development or regulatory review or approval process, and it does not increase the likelihood that the product candidate will receive marketing approval.· ● ● ● ● ● 5 ▸ group Risks Related to Our Business Operations and Product Candidates· ● ● ● ● ● 5 rw ▸ We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.· ● ● ● ● ● 5 rw ▸ Adverse drug reactions and negative results from off-label use of our commercialized product, ETUARY, which is approved in the PRC, future commercialized products, including nintedanib and avatrombopag,· · · · ● · 1 ▸ Certain residents of the PRC may hold direct or indirect interests in our company, and we will request residents of the PRC who we know hold direct or indirect interests in our company, if any, to make the necessary· · · · ● · 1 ▸ If any new legislation, executive orders, tariffs, laws and/or regulations are implemented, if existing trade agreements are renegotiated, if the U.S. or the PRC governments take retaliatory actions due to the recent· · · · ● · 1 ▸ Interference proceedings provoked by third parties or brought by us may be necessary to determine the priority of inventions with respect to our patents or patent applications or those of our licensors. An unfavorable· · · · ● · 1 ▸ We may identify material weaknesses or significant deficiencies in our internal control over financial reporting in the future or fail to maintain effective internal control over financial reporting, which may· · · · ● · 1 ▸ As of December 31, 2023 and 2022, our trade receivables amounted to $15.2 million and $15.6 million, respectively, which primarily represented the balances due from our distributors. Our liquidity and cash flow are directly affected· · · ● · · 1 ▸ Co. that permits us, subject to applicable SEC regulations, to issue up to $50.0 million of shares of our common stock in “at the market” transactions at prevailing market prices.· · · ● · · 1 ▸ It is possible that the integration process also could result in the diversion of our management’s attention, the disruption or interruption of, or the loss of momentum in, our business or inconsistencies in standards, controls, procedures and· · · ● · · 1 ▸ Modifications to laws, regulations, and rules by the PRC government could lead to alterations in our operational processes and business approaches.· · · ● · · 1 ▸ Our commercialized product, ETUARY, which is approved in the PRC, and any other future product, if approved, may be excluded or removed from national, provincial or other government-sponsored medical insurance programs.· · · ● · · 1 ▸ Our plan to grow our business through such acquisitions may not materialize as expected.· · · ● ● · 2 ▸ Our substantial investment in research and development in order to develop our product, ETUARY, and other product candidates, and to enhance our technologies may ultimately fail to materialize.· · · ● · · 1 ▸ The China National Intellectual Property Administration (the “CNIPA”) and other governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the· · · ● · · 1 ▸ We face substantial competition that may result in others discovering, developing, commercializing or marketing products, including our commercialized product, ETUARY, which is approved in the PRC, before or more successfully than we do.· · · ● ● · 2 ▸ We may be unable to integrate successfully and realize the anticipated benefits of the Contributions.· · · ● · · 1 ▸ We may fail to maintain or expand an effective distribution network for our commercialized product, ETUARY, which is approved in the PRC, and any other future products, if approved, or further expand our distribution channel.· · · ● · · 1 ▸ We may not be able to meet the increasing demand for our commercialized product, ETUARY, which is approved in the PRC, and any other future products, if approved, maintain adequate manufacturing capacity or successfully manage our anticipated growth.· · · ● · · 1 ▸ A third-party may hold intellectual property, including patent rights, that is important or necessary to the development of its products. It may be necessary for Catalyst to use the patented or proprietary technology of third parties to· · ● · · · 1 ▸ A variety of risks associated with marketing our product candidates internationally may materially adversely affect our business.· · ● ● · · 2 rw ▸ Although there are no currently approved therapeutic drug treatments for liver fibrosis, several companies are developing product candidates in clinical studies.· · ● · · · 1 ▸ Catalyst has recently received a Nasdaq notice for failing to comply with the minimum bid price listing requirement and there is no assurance Catalyst will regain compliance or maintain its Nasdaq listing.· · ● · · · 1 ▸ Catalyst is substantially dependent on the success of its lead product candidate, Hydronidone, and its future clinical trials of Hydronidone may not be successful.· · ● · · · 1 ▸ Catalyst may be subject to a new 1% U.S. federal excise tax in connection with the issuance of the CVRs.· · ● · · · 1 ▸ Catalyst may not be able to continue as a going concern if the conversion of Catalyst Convertible Preferred Stock is not approved by its stockholders.· · ● · · · 1 ▸ group Risks Related to Catalyst· · ● · · · 1 ▸ group Risks Related to the Business Combination Transactions· · ● · · · 1 ▸ group Risks Related to the Strategic Transactions· · ● · · · 1 ▸ Catalyst may not be successful in its efforts to build a pipeline of additional product candidates.· ● ● · · · 2 rw ▸ We may not be able to identify or execute any strategic alternatives.· ● · · · · 1 ▸ Anti-takeover provisions in its charter documents and provisions of Delaware law may make an acquisition more difficult and could result in the entrenchment of management.● ● ● · · · 3 rw ▸ CB 2782-PEG, CB 4332 and all of our other product candidates will require additional clinical testing before they can be sold.● ● · · · · 2 rw ▸ Catalyst expects to seek to establish additional collaborations, and, if Catalyst is not able to establish them on commercially reasonable terms, Catalyst may have to alter its development and commercialization plans.● ● ● · · · 3 rw ▸ Catalyst faces substantial competition that may result in others discovering, developing or commercializing products before or more successfully than Catalyst does.● ● ● · · · 3 rw ▸ Catalyst has incurred significant losses since its inception and is expected to continue to incur significant losses for the foreseeable future.● ● ● · · · 3 rw ▸ Catalyst is subject to many manufacturing risks, any of which could substantially increase its costs and limit supply of its product candidates and any future products.● ● ● · · · 3 rw ▸ Catalyst’s future success depends on its ability to retain key executives and to attract, retain and motivate qualified personnel.● ● ● · · · 3 rw ▸ Even if Catalyst commercializes any product candidates, the products may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives that would harm its business.● ● ● · · · 3 rw ▸ Fast Track designation by the FDA may not actually lead to a faster development or regulatory review or approval process.● ● · · · · 2 ▸ If Catalyst is unable to obtain, protect or enforce intellectual property rights related to its product candidates, Catalyst may not be able to compete effectively in its markets.● ● ● · · · 3 rw ▸ If the market opportunities for our product candidates are smaller than expected, our revenues may be adversely affected and our business may suffer.● ● · · · · 2 ▸ If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals, we will not be able to commercialize our product candidates, and our ability to generate revenue will be materially impaired.● ● · · · · 2 ▸ If we are unable to establish sales, marketing and distribution capabilities, we may not be successful in commercializing our product candidates if they are approved.● ● · · · · 2 ▸ If we do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully commercialize our product candidates, which would materially harm our business.● · · · · · 1 ▸ Our ability to compete in the highly competitive biotechnology and pharmaceutical industries depends upon our ability to attract and retain highly qualified managerial, scientific and medical personnel. We are highly dependent● · · · · · 1 ▸ Our business could be negatively affected as a result of actions of activist stockholders, and such activism could impact the trading value of our securities.● ● · · · · 2 ▸ Our collaboration with Biogen may not result in successful product development or payments to us.● · · · · · 1 ▸ Our complement product candidates may cause the generation of neutralizing antibodies, which could prevent their further development.● ● · · · · 2 rw ▸ group Risks Related to Catalyst’s Common Stock● ● ● · · · 3 rw ▸ Specifically, there are a large number of companies developing or marketing treatments for hemophilia, including many major pharmaceutical and biotechnology companies, including Novo Nordisk, which has developed● · · · · · 1 ▸ The FDA may disagree with our regulatory plan and we may fail to obtain regulatory approval of our product candidates.● ● · · · · 2 ▸ The market price of Catalyst Common Stock has historically been highly volatile.● ● ● · · · 3 rw ▸ The operations of our third-party manufacturers may be requisitioned, diverted or allocated by U.S. or foreign government orders such as under emergency, disaster and civil defense declarations in connection with the COVID-19 pandemic or otherwise.● ● · · · · 2 ▸ The outbreak of the novel coronavirus disease, COVID-19, could adversely impact our business, including our preclinical studies.● ● · · · · 2 rw ▸ We are a smaller reporting company, and we cannot be certain if the reduced disclosure requirements applicable to smaller reporting companies will make our common stock less attractive to investors.● ● ● ● · · 4 rw ▸ We have no history of obtaining regulatory approval or commercialization of pharmaceutical products, which may make it difficult to evaluate the Company’s prospects.● ● · · · · 2 rw ▸ We may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.● ● ● ● · · 4 rw ▸ We or the third parties upon whom we depend may be adversely affected by earthquakes or other natural disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.● ● · · · · 2 ▸ Fluctuations in operating results could adversely affect the price of our common stock.● ● ● ● ● ● 6 rw ▸ If we experience delays or difficulties in the commencement of clinical trials or patient enrollment in clinical trials, our regulatory approvals could be delayed or prevented.● ● ● ● ● ● 6 rw ▸ 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 harm our business.● ● ● ● ● ● 6 rw ▸ Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities.● ● ● ● ● ● 6 rw ▸ Many of our product candidates are years away from regulatory approval.● ● ● ● ● ● 6 rw ▸ Our employees, principal investigators, consultants and commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading.● ● ● ● ● ● 6 rw ▸ Our results of operations may be adversely affected by current and potential future healthcare legislative and regulatory actions.● ● ● ● ● ● 6 rw ▸ Raising additional funds by issuing securities or through licensing arrangements may cause dilution to stockholders, restrict our operations or require us to relinquish proprietary rights.● ● ● ● ● ● 6 rw ▸ Risks Related to Commercialization of Our Product and Product Candidates● ● ● ● ● ● 6 rw ▸ Risks Related to Employee Matters, Managing Growth and Our Business Operations● ● ● ● ● ● 6 rw ▸ group Risks Related to Our Financial Condition and Capital Requirements● ● ● ● ● ● 6 rw ▸ group Risks Related to Our Intellectual Property● ● ● ● ● ● 6 rw ▸ group Risks Related to Our Reliance on Third Parties● ● ● ● ● ● 6 rw ▸ Risks Related to Regulatory Approval of Our Product Candidates and Other Compliance Matters● ● ● ● ● ● 6 rw ▸ Risks Related to the Discovery, Development and Commercialization of Our Product Candidates● ● ● ● ● ● 6 rw ▸ Sales of a significant number of shares of our common stock in the public markets, or the perception that such sales could occur, could depress the market price of our common stock.● ● ● ● ● ● 6 rw ▸ The scope of our patent protection may be uncertain, and third-party claims of intellectual property infringement or challenging the inventorship or ownership of our patents may prevent or delay our development and commercialization efforts.● ● ● ● ● ● 6 rw ▸ We may be involved in lawsuits to protect or enforce our patents.● ● ● ● ● ● 6 rw ▸ We may need to license certain intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms.● ● ● ● ● ● 6 rw ▸ We rely on third parties to conduct certain aspects of our preclinical studies and any clinical trials, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such tasks or trials.● ● ● ● ● ● 6 rw ▸ We will continue to incur significant costs as a result of operating as a public company, and our management is required to devote substantial time to compliance with regulations related to operating as a public company.● ● ● ● ● ● 6 rw 
