UNCY 10-K & 10-Q changes, risk factors and insider trading

On March 13, 2024, we entered into a securities purchase agreement with certain accredited investors pursuant to which sold 50,000 shares of our Series B Convertible Preferred Stock at a purchase price of $1,000 per share with an initial conversion price of $1.00 per share, for an aggregate purchase price of $50.0 million.$50.0million.

In addition, on November 13, 2024, we entered into a Salessales Agreement,agreement, with Guggenheim Securities, LLC as amended by Amendment No. 1 thereto on November 14, 2025 (as amended, the “Sales Agreement”) pursuant to which, we may offer and sell shares of our common stock having an aggregate offering price of up to $50 $100 million, subject to certain limitations and in accordance with the terms of the Sales Agreement, from time to time through or to Guggenheim Securities, acting as sales agent or principal.

-3939-- If we cannot raise adequate funds to satisfy our our capital requirements, we will have to delay, scale back or eliminate our research and development activities, clinical studies or future future operations. We may also be required to obtain funds through arrangements with collaborators, which arrangements may require us to relinquish rights to certain technologies or products that we otherwise would not consider relinquishing, including rights to future product candidates or certain major geographic markets. This could result in sharing revenues which we might otherwise retain for ourselves. Any of these actions may harm our business, financial condition and results of operations.

-3636-- The amount of capital we may need depends on many many factors, including the progress, timing and scope of our product development programs; the progress, timing and scope of our pre-clinical studies and clinical trials; the time and cost necessary to obtain regulatory approvals; the time and cost necessary to further develop manufacturing processes and arrange for contract manufacturing; our ability to enter into and maintain collaborative, licensing and other commercial relationships; and our partners’ commitment of time and resources to the development and commercialization of our products.

We may seek additional capital through a variety of means, including through private and public equity offerings and debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, or through the issuance of shares under management or other types of contracts, or upon the exercise or conversion of outstanding derivative securities, the ownership interests of our stockholders will be diluted, and the terms of such financings may include liquidation or other preferences, anti-dilution rights, conversion and exercise price adjustments and other provisions that adversely affect the the rights of our stockholders, including rights, preferences and privileges that are senior to those of our holders of common stock in the the event of a liquidation. In addition, debt financing, if available, could include covenants limiting or restricting our ability to take take certain actions, such as incurring additional debt, making capital expenditures, entering into licensing arrangements, or declaring dividends dividends and may require us to grant security interests in our assets. If we raise additional funds through collaborations, strategicstrategi calliances, alliances, or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, product or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debtordebt financings when needed, we may need to curtail or cease our operations.

You will experience dilution, subordination of stockholder rights, preferences, and privileges, and decrease in market price of our common stock as a result of our private placement financing efforts in March 2023 and March 2024.

On March 3, 2023, we signed a securities purchase agreement with certain healthcare-focused institutional investors pursuant to which we issued and sold 30,190 shares of Series A-1 Preferred Stock. Such Series A-1 Preferred Stock and the securities issuable upon conversion of the Series A-1 Preferred Stock are potentially dilutive instruments instruments and the conversion of these securities upon Stockholder Approval in 2023 resulted in dilution to our existing stockholders: On July 11, 2023, the Series A-1 Preferred Stock was converted into 19,516,2051,951,621 shares of common stock as well as 43,649 shares of Series A-2 Preferred Stock and Tranche A Warrants exercisable for Series A-3 Preferred Stock convertible into 47,852,4304,785,243 shares of common stock, Tranche B Warrants exercisable for Series A-4SeriesA-4 Preferred Stock convertible into 43,502,2064,350,229 shares of common stock and Tranche C warrants exercisable for Series A-5 Preferred Stock convertible into 69,609,5316,960,362 shares of commons stock. In March 2024, the 43,649 shares of Series A-2 Preferred Stock was exchanged for 21,388.01 shares of Series A-2 Prime Preferred Stock convertible into 43,649,0004,364,900 shares of common stock. As of the date of this report there were outstanding 2,265 shares of Series A-2 Prime Preferred Stock convertible into 462,245 shares of common stock. In addition, there were outstanding Tranche A Warrants exercisable for Series A-3 Preferred Stock convertible into 4,508,252 shares of common stock, Tranche B Warrants exercisable for SeriesA-4 Preferred Stock convertible into 4,350,229 shares of common stock and Tranche C warrants exercisable for Series A-5 Preferred Stock convertible into 6,960,362 shares of commons stock.

-4040-- As a result of the agreements, these stockholders, acting together, may have the ability to control the outcome of matters submitted to our stockholders for approval, including the election of directors and any merger, consolidation or sale of all or substantially all of our assets. In addition, these stockholders, acting together, may have the ability to control the management and affairs of our company.

-4141-- In addition, the process of seeking regulatory clearance or approval to market the product candidates we intend to develop is expensive and time consumingtime-consuming and, notwithstanding the effort and expense incurred, clearance or approval is never guaranteed. If we are not successful in obtaining timely clearance or approval of our product candidates from the FDA, we may never be able to generate anticipated revenue and may be forced to cease operations. The NDA process is costly, lengthy and uncertain. Any NDA application filed by us will have to be supported by extensive data, including, but not limited to, technical, pre-clinical, clinical, manufacturing, and labeling data, to demonstrate to the FDA’s satisfaction the safety and efficacy of the product for its intended use.

Obtaining clearances or approvals from the FDA and from the regulatory agencies in other countries is an expensive and time-consuming process and is uncertain as to outcome. The FDA and other agencies could ask us to supplement our submissions, collect new CMC or non-clinical data, conduct additional clinical trials or engage in other time-consuming actions, or it could simply deny our applications. In addition, even if we obtain an NDA approval or pre-market approvals in other countries, the approval could be revoked, or other restrictions imposed if post-market data demonstrate safety issues or lack of effectiveness. In response to our initial NDA submission, the FDA issued a CRL notifying us that a third-party manufacturing vendor of its main contract development and manufacturing organization (CDMO) was cited for deficiencies following a cGMP inspection. We resubmitted an NDA in December 2025 and the FDA set a PDUFA target action date of June 29, 2026. If the third party fails inspection again or if the NDA is rejected again, we will need to make another NDA submission and our target PDUFA target action date will be extended by another 6-12 months. We cannot predict with certainty how, or when, the FDA or other regulatory agencies will act. If we are unable to obtain the necessary regulatory approvals, our financial condition and cash flow may be adversely affected, and our ability to grow domestically and internationally may be limited. Additionally, even if cleared or approved, our products may not be approved for the specific indications that are most necessary or desirable for successful commercialization or profitability.

-3939-- Any inability to successfully complete pre-clinical and clinical development could result in additional costs to us or impair our ability to generate revenues from product sales, regulatory and commercialization milestones and royalties. In addition, if we make manufacturing or formulation changes to our product candidates, we may need to conduct additional studies to bridge our modified product candidates to earlier versions.

-4343-- Additionally, our product candidates could potentially cause other adverse events that have not yet been predicted. The inclusion of ill patients in our clinical studies may result in deaths or other adverse medical events due to other therapies or medications that such patients may be using. As described above, any of these events could prevent us from achieving or maintaining market acceptance of our product candidates and impair our ability to commercialize our products.

-4040-- We must obtain marketing approval in each jurisdiction in which we market our products. Failure to obtain marketing approval for a product candidate will prevent us from commercializing the product candidate. We have not submitted a marketing application or received approval to market any of our product candidates from regulatory authorities in any jurisdiction. We have only limited experience in filing and supporting the applications necessary to gain marketing approvals and expect to rely on third-party CROs to assist us in this process. Securing regulatory approval requires the submission of extensive pre-clinical and clinical data and supporting information to the various regulatory authorities for each indication to establish the product candidate’s safety and efficacy. Securing regulatory approval also requires the submission of information about the product manufacturing process, testing and release and inspection of manufacturing facilities and personnel by the relevant regulatory authority. Our product candidates may not be effective, may be only moderately effective or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude our obtaining marketing approval or prevent or limit commercial use.

-4343-- Our ability to commercialize our current and any any future product candidates successfully also will depend in part on the extent to which coverage and adequate reimbursement for these products products and related treatments will be available from government health programs, private health insurers, integrated delivery networks and other third-party payors. Third-party payors decide which medications they will pay for and establish reimbursement levels. A significant trend trend in the U.S. healthcare industry and elsewhere is cost containment. Government authorities and third-party payors have attempted to control costs by limiting coverage and the amount of payment for particular medications. Increasingly, third-party payors are requiring that drug companies provide predetermined discounts from list prices and are challenging the prices charged for medical products. Coverage and reimbursement may not be available for any product that we commercialize and, if reimbursement is available, the level of reimbursement may not be sufficient for commercial success. Coverage and reimbursement may impact the demand for, or the price of, any product candidate for which we obtain marketing approval. If coverage and reimbursement is not available or is available only to limited levels, we may not be able to successfully commercialize any product candidate for which we obtain marketing approval.

-4444-- In addition, later discovery of previously unknown problems with our products, manufacturers or manufacturing processes and facilities or failure to comply with regulatory requirements, may result in, among other things:

We rely on suppliers, vendors and partners for certain key aspects of our business, including support for information technology systems and certain human resource functions. We do not control these partners, but we depend on them in ways that may be significant to us. For example, our third-party manufacturing vendor of its main contract development and manufacturing organization (CDMO) was cited for deficiencies following a cGMP inspection resulting in the FDA issuing us a CRL for our initial NDA submission which resulted in us having to resubmit an NDA causing delay in our target action PFUDA date of 12-months. If these parties fail to meet our expectations or fulfill their obligations to us, we may fail to receive the expected benefits. In addition, if any of these third parties fails to comply with applicable laws and regulations in the course of its performance of services for us, there is a risk that we may be held responsible responsible for such violations as well. This risk is particularly serious in emerging markets, where corruption is often prevalent and where many of the third parties on which we rely do not have internal compliance resources comparable to our own. Any such failures by third parties, in emerging markets or elsewhere, could adversely affect our business, reputation, financial condition or results of operations.

-4646-- We may be unable to establish agreements with third-party manufacturers for clinical or commercial supply on terms favorable to us, or at all. Even if we are able to establish agreements with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:

Third-party manufacturers may not be able to comply with U.S. cGMPs or similar regulatory requirements outside the United States. Our failure, or the failure of our third-party manufacturers, manufacturers, or their subcontractors, to comply with cGMPs or other applicable regulations, even if such failures do not relate specifically to our product candidates or approved products, could result in sanctions being imposed on us or the manufacturers, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates, operating restrictions and criminal prosecutions, any of which could adversely affect supplies of our product candidates and harm our business and results of operations. For example, our third-party manufacturing vendor of its main contract development and manufacturing organization (CDMO) was cited for deficiencies following a cGMP inspection resulting in the FDA issuing us a CRL for our initial NDA submission which resulted in us having to resubmit an NDA causing delay in our target action PFUDA date of 12-months.

-5050-- Furthermore, we expect to rely on third parties parties to release, label, store and distribute drug supplies for our clinical trials. Any performance failure on the part of these third parties, including a failure that may not relate specifically to our product candidates, could delay or otherwise adversely impact clinical development or marketing approval of our product candidates or commercialization of our drug, producing losses and depriving us of potential revenue. Our supplier Shilpa Medicare Ltd was reviewdreviewed by the FDA in March 2025.

Our current product candidates and future candidates face, and will continue to face, intense competition from large pharmaceutical companies, as well as academic and research institutions. We compete in an industry that is characterized by: (i) rapid technological change, (ii) evolving industry standards, (iii) emerging competition and (iv) new product introductions. Our competitors have existing products and technologies that will compete with our products and technologies and may develop and commercialize additional products and technologies that will compete with our products and technologies. Because several several competing companies and institutions have greater financial resources than us, they may be able to: (i) provide broader services and product lines, (ii) make greater investments in research and development and (iii) carry on larger research and development initiatives than us. Our competitors also have greater development capabilities than we do and have substantially greater experience in undertaking pre-clinical pre-clinical and clinical testing of products, obtaining regulatory approvals, and manufacturing and marketing pharmaceutical products. They also have greater name recognition and better access to customers than us.

-4848-- Prior to engaging in future clinical trials, we intend to obtain product liability insurance coverage at a level that we believe is customary for similarly situated companies and adequate to provide us with insurance coverage for foreseeable risks; however, we may be unable to obtain such coverage at a reasonable cost, if at all. If we are able to obtain product liability insurance, we may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise, and such insurance may not be adequate to cover all liabilities that we may incur. Furthermore, we intend to expand our insurance coverage for products to include the sale of commercial products if we obtain regulatory approval for our product candidates in development, but we may be unable to obtain commercially reasonable product liability insurance for any products that receive regulatory approval. Large judgments have been awarded in class action lawsuits based on drugs that had unanticipated side effects. A successful product liability claim or series of claims brought against us, particularly if judgments exceed our insurance coverage, could decrease our cash and adversely affect our business.

Disruptions at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, over the last several years, including beginning on December 22, 2018, the U.S. government has shutshutdown downseveral several times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical FDA, SEC and other government employees employees and stop critical activities. If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Further, upon completion of of this offering and in our operations as a public company, future government shutdowns could impact our ability to access the public markets markets and obtain necessary capital in order to properly capitalize and continue our operations.

On October 1, 2017, we entered into an exclusive license agreement (the “Sphaera License Agreement”) with Sphaera Pharma Pte. Ltd., a Singaporean pharmaceutical corporation (“Sphaera”). Pursuant to the Sphaera License Agreement, we acquired an exclusive royalty-bearing worldwide license to develop, make, have made, use, practice, research, distribute, lease, sell, offer for sale, license, import or otherwise dispose of certain rights owned or controlled by Sphaera and/or any of its affiliates, related to UNI 494 (the “UNI 494 Rights”). We also acquired a a non-exclusive license to certain know-how and technology related to the UNI 494 Rights. In the event that either party to the Sphaera License Agreement breaches any of its material obligations thereunder, the nonbreachingnon-breaching party, at its sole option and discretion, will have the right to terminate the Sphaera License Agreement, provided that it must give the breaching party written notice specifying the nature of the breach, amounts of certain royalties and other payments then due, if any. The non-breaching Party’s termination notice is effective 90 days from receipt of the written notice if the breaching party has failed to cure such breach within the 90-day period. If the Sphaera License Agreement were to be terminated by Sphaera due to our material breach, we would lose a significant asset and may no longer be able to develop our product candidates, which would have a material adverse effect on our operations.

-5151-- Others may file patent applications covering products products and technologies that are similar, identical or competitive to ours or important to our business. We cannot be certain that any patent application owned by a third party will not have priority over patent applications filed or in-licensed by us, or that we or our licensors will not be involved in interference, opposition, reexamination, review, reissue, post grant review or invalidity proceedings before U.S. or non-U.S. patent offices.

-5252-- 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 our product candidates.

-5656-- If we are sued for patent infringement, we would need to demonstrate that our product candidates or methods either do not infringe the patent claims of the relevant patent or that the patent claims are invalid, and we may not be able to do this. Proving invalidity is difficult. For example, in the U.S., proving invalidity requires a showing of clear and convincing evidence to overcome the presumption of validity enjoyed by issued patents. Even if we are successful in these proceedings, we may incur substantial costs and diversion of management’s time and attention in pursuing these proceedings, which could have a material adverse effect on us. If we are unable to avoid infringing the patent rights of others, we may be required to seek a license, which may not be available, defend an infringement action or challenge the validity of the patents in court. court. Patent litigation is costly and time consuming. We may not have sufficient resources to bring these actions to a successful conclusion. In addition, if we do not obtain a license, develop or obtain non-infringing technology, fail to defend an infringement action successfully or have infringed patents declared invalid, we may incur substantial monetary damages, encounter significant delays in bringing our product candidates to market and be precluded from manufacturing or selling our product candidates.

-5757-- We may elect to sue a third party, or otherwise make a claim, alleging infringement or other violation of patents, trademarks, trade dress, copyrights, trade secrets, domain names or other intellectual property rights that we either own or license from a third party. If we do not prevail in enforcing our intellectual property rights in this type of litigation, we may be subject to:

-5454-- A third party may also challenge the validity, enforceability or scope of the intellectual property rights that we license or own and the result of these challenges may narrow the scope scope or claims of or invalidate patents that are integral to our product candidates in the future. There can be no assurance that we will be able to successfully defend patents we own or license in an action against third parties due to the unpredictability of litigation and and the high costs associated with intellectual property litigation, amongst other factors.

-5959-- In the current reimbursement environment, oral phosphate lowering therapies like OLC are covered by Medicare under Part D for the treatment of patients with hyperphosphatemia. In January 2011, CMS implemented the ESRD PPS, a prospective payment system for dialysis treatment. Under the ESRD PPS, CMS generally makes a single bundled payment to the dialysis facility for each dialysis treatment that covers all items and services routinely required for dialysis treatments furnished to Medicare beneficiaries in Medicare-certified ESRD facilities or at their home. The inclusion of oral medications without injectable or intravenous equivalents such as OLC in the bundled payment was initially delayed by CMS until January 1, 2014, and through several subsequent legislative actions has been delayed until January 1, 2025. Given the potential approval timeline for OLC in mid-2025, our drug would be launched into this bundled setting.

-5656-- Medicaid reimbursement of drugs varies by state. Private third-party payor reimbursement policies also vary and may or may not be consistent with Medicare reimbursement methodologies. Manufacturers of outpatient prescription drugs may be required to provide discounts or rebates under government healthcare programs or to certain third-party payors in order to obtain coverage of such products.

-6060-- Similar to how payor coverage may affect the sales sales of a product, formulary status within dialysis organizations may affect what products are prescribed within that specific organization. Therefore, if a product is not on a formulary, the prescribers within that organization may be less likely to prescribe that product or or may have a difficult time prescribing that product, resulting in less sales. Further, one dialysis organization’s determination to add a product to their formulary does not assure that other dialysis organizations will also add the product to theirs. There is always a risk a dialysis organization will not contract with a drug manufacturer for a specific product, resulting in that product not being on that organization’s formulary. If any dialysis organization does not add OLC, if approved, to the formulary, our business may be materially harmed.

-5858-- Some of the provisions of the ACA have yet to be implemented, and there have been legal and political challenges to certain aspects of the ACA. The former Trump administration issued certain executive orders and other directives designed to delay, circumvent, or loosen certain requirements mandated by the ACA. Concurrently, Congress considered legislation that would repeal or repeal and replace all or part of the ACA. While Congress has not passed repeal legislation, the Tax Cuts and Jobs Act of 2017 included a provision repealing, effective January 1, 2019, the tax-based shared responsibility payment imposed by the ACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individual mandate.” Congress may consider other legislation to repeal or replace elements of the ACA.

Individual states have become increasingly aggressive in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access, and marketing cost disclosure and transparency measures, and to encourage importation from other countries and bulk purchasing. Legally mandated price controls on payment amounts by third-party payors or other restrictions could harm a pharmaceutical manufacturer’s business, results of operations, financial condition and prospects. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. This could reduce ultimate demand for certain products or put pressure on product pricing, which could negatively affect a pharmaceutical manufacturer’s business, results of operations, financial condition and prospects.

In addition, given recent federal and state government initiatives initiatives directed at lowering the total cost of healthcare, the BidenTrump administration, Congress and state legislatures will likely continue to focus on healthcare reform, the cost of prescription drugs and biologics and the reform of the Medicare and Medicaid programs. For example, example, there have been several recent U.S. congressional inquiries and proposed federal and proposed and enacted state legislation designed to, to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, reduce the costs of drugs under Medicare and reform government program reimbursement methodologies for drug products. Further, in July 2020, former President Trump issued a number of executive orders that are intended to lower the costs of prescription drug products including one that directs HHS to finalize the rulemaking process on modifying the anti-kickback law safe harbors for discounts for plans, pharmacies, and pharmaceutical benefit managers. No assurance can be given whether these orders will remain in effect under the Biden administration.

-5959-- Furthermore, regulatory authorities’ assessment of the data and results required to demonstrate safety and efficacy can change over time and can be affected by many factors, such as the emergence of new information, including on other products, changing policies and agency funding, staffing and leadership. We cannot be sure whether future changes to the regulatory environment will be favorable or unfavorable to our business prospects. For example, average review times at the FDA for marketing approval applications can be affected by a variety of factors, including budget and funding levels and statutory, regulatory and policy changes.

-6666-- There is no assurance that we will be able to maintain compliance with the Nasdaq Capital Market continued listing standards and/or continue our listing on the Nasdaq Capital Market in the future.

As of December 31, 2024,2025, our directors, executive officers and principal stockholders, and their respective affiliates, beneficially own approximately 63%39% of our outstanding shares of common stock. As a result, these stockholders, acting together, have the ability to control the outcome of matters submitted to ourours stockholders for approval, including the election of directors and any merger, consolidation or sale of all or substantially all of our assets. In addition, these stockholders, acting together, have the ability to control the management and affairs of our company. Accordingly, this concentration of ownership might harm the market price of our common stock by:

We are a clinical-stage biotechnology company focused on identifying, developing, and commercializing innovative therapies to address significant unmet medical needs, with an initial focus on kidney disease. Founded in 2016, Unicycivewe waswere established to create a streamlined and efficient drug development platform capable of accelerating the advancement of promising therapies from discovery to commercialization. Currently, our two programs are focused on kidney disease, an area we believe we have the potential to offer medical benefit. Our initial focus is on developing drugs and getting them approved in the U.S., and then to partner with global biopharmaceutical companies in the rest of the world. As we grow the company and build our team, we intend to focus on identifying medical conditions within and outside of kidney disease. Our business model is to to license technologies and drugs in order to pursue development, regulatory approval, and commercialization of those products in global markets. Many biotechnology companies utilize similar strategies of in-licensing and then developing and commercializing drugs. We believe, however, that our management team’s broad network, expertise in the biopharmaceutical industry, and successful track record gives us an advantage in identifying and bringing these assets into our company.

-7373-- Since our formation we have devoted substantially all of our resources to developing our product candidates. We have incurred significant operating losses to date. Our net losses were $30.5$36.7 million and $36.7$26.6 million for the years ended December 31, 20232024 and 20242025 respectively. As of December 31, 2024,2025, we had an accumulated accumulated deficit of $101.3$127.8 million. We expect that our operating expenses will increase significantly as we advance our product candidates through through pre-clinical and clinical development, seek regulatory approval, and prepare for and, if approved, proceed to commercialization; acquire, acquire, discover, validate, and develop additional product candidates; obtain, maintain, protect and enforce our intellectual property portfolio; and hire additional personnel.

Substantially all of our research and development expenses consist of expenses incurred in connection with the development of our product candidates. These expenses include fees paid to to third parties to conduct certain research and development activities on our behalf, consulting costs, costs for laboratory supplies, product product acquisition and license costs, certain payroll and personnel-related expenses, including salaries and bonuses, employee benefit costs costs and stock-based compensation expenses for our research and product development employees and allocated overheads, including information technology costs and utilities and expenses for the issuance of shares pursuant to the anti-dilution clause in the purchase of in process research and development technology. We expense both internal and external research and development expenses as they are incurred.

-7474-- We do not allocate our costs by product candidate, as a significant amount of research and development expenses include internal costs, such as payroll and other personnel expenses, laboratory supplies and allocated overhead, and external costs, such as fees paid to third parties to conduct research and development activities on our behalf, are not tracked by product candidate.

General and administrative expenses consist principally of payroll and personnel expenses, including salaries and bonuses, benefits and stock-based compensation expenses, professional fees for legal, legal (including patent costs), consulting, accounting and tax services, including information technology costs and utilities, and other general operatingcorporate expenses not otherwise classified as research and developmentoverhead expenses.

Research and development expenses increaseddecreased by approximately $7.1$10.9 million, or 55%54%, from $12.9approximately $20.0 million for the year ended December 31, 20232024 to $20.0approximately $9.1 million for the year ended December 31, 2024.2025. TheThis increase in research and development expensesdecrease was primarily duedriven toby ana increasereduction in drug development costs of $6.1$8.0 million million. Thereand wasa $750,000 increasedecline in laborclinical costs.costs Non-cashof stock$3.4 million. These decreases were partially offset by increased costs, including $0.2 million in consulting and professional services and $0.2 million in labor. Additionally, stock-based compensation increasedrose $211,000.by $0.1 million.

General and administrative expenses increased by approximately $3.5$8.3 million, or 42%,69%, from $8.5 million for the year ended December 31, 2023 toapproximately $12.1 million for the year ended December 31, 2024 to approximately $20.4 million for the 2024year ended December 31, 2025. This increase was primarily duedriven toby ana increase$2.4 ofmillion $1.5rise in marketing expenses associated with the commercial launch, $3.5 million in higher consulting and professional servicesservice costs. Labor costs increased $319,000 due to hiring of new employees,costs, and $1.8 million in labor and related expenses. Additionally, rent, travel, suppliessupplies, and other costs increased $2.7by million.$0.5 Non-cashmillion, stockwhile stock-based compensation costs increased $371,000. The increases were partially offsetgrew by a$0.1 decrease in insurance expense for directors and officers of $168,000.million.

Other income (expenses) decreased improved by approximately $5.2$7.6 million, or 53%164%, from $9.8an expense of $4.6 million for the year ended December 31, 20232024, to approximatelyincome $4.6of $3.0 million for the year ended December 31, 2024.2025. The increaseThis was due primarily todriven theby a favorable change in the fair value of our warrant liability.liability, Wepartially offset by a decrease of earned interest income of $1.3 million on our cash balance during the year thatas wasa partiallyresult offsetof bylower $71,000average incash interestbalances expense.available for interest-bearing accounts.

Since our formation through JuneDecember 2021,31, 2020, we have funded our operations with the sale of common and preferred stock, convertible notes and from a loan from our Chief Executive Officer and principal stockholder.

InAs connectiona withresult of our initial public offering (“IPO”), on July 13, 2021,2021 we began trading on the Nasdaq Capital Market under the symbol “UNCY”, and on July 15, 2021 we received approximately $22.3 million in net proceeds after deducting the underwriting discounts, commissions and offering expenses. We have used the net proceeds from the IPO to complete pre-clinical and clinical studies, submit regulatory filings to the FDA, and for general and corporate purposes, including hiring additional employeesmanagement and conducting market research and other commercial planning.

Future revenue streams may consist of collaboration or licensing revenue as well as product sales. We have generated approximately $1.6 million in licensing revenue to date.

On March 3, 2023, we entered into a securities purchase agreement with certain healthcare-focused institutional investors that may provide up to $130.0 million in gross proceeds through a private placement and that includesincluded initial upfront funding of $30.0 million. Proceeds from the offering will be used to support our NDA submission with the FDA for approval of Oxylanthanum Carbonate for the treatment of hyperphosphatemia in the U.S. and, if approved, for the commercial launch of Oxylanthanum Carbonate in the U.S.

On March 13, 2024, the Companywe entered into a securities securities purchase agreement with certain accredited investors pursuant to whichprovide we$50 agreed to issue and sell,million in gross proceeds through a private placement,placement. Pursuant to 50,000the securities purchase agreement, we issued institutional purchasers $50.0 million in shares of our Series B Convertible Preferred Stock,Stock. We parreceived value$46.2 $0.001million perin sharenet at a purchase price of $1,000 per share with an initial conversion price of $1.00 per share, subject to adjustment for an aggregate purchase price of $50 million.proceeds.

In addition, onOn November 13, 2024, we entered into a Salessales Agreement,agreement, with Guggenheim Securities, LLC pursuant to which, we may offer and sell shares of our common stock having an aggregate offering price of up to $50$50.0 million, subject to certain limitations and in accordance with the terms of the Salessales Agreement, agreement, from time to time through or to Guggenheim Securities, LLC acting as sales agent or principal. FromOn November 14, 2025, the Company entered into an Amendment No. 1 to sales agreement with Guggenheim Securities LLC to increase the number of shares that may be sold under the sales agreement to $100,000,000 (collectively with the November 13, 2024 sales agreement, the “Sales Agreement”). During the period from October 1, 2025 through December 31, 2025, the Company 2024 we have sold 977,4071,263,882 shares of common stock pursuant to the Sales Agreement, at an average price of $0.72$5.77 per share resulting in aggregate gross proceeds of approximately $0.7 million, for which itand paid Guggenheim$0.2 approximately $21,000million in commissions, resulting in net proceeds to the Company of approximately $0.7 $6.6 million. During the year ended December 31, 2025, the Company sold 9,310,618 shares of common stock pursuant to the Sales Agreement, at an average price of $5.40 per share and paid $1.4 million in commissions, resulting in net proceeds to the Company of approximately $45.2 million.

We expect to continue incurring losses in the future and will be required to raise additional capital in the future to complete plannedour clinical trials, pursue product development initiatives initiatives and penetrate markets for the sale of our products. ManagementWe believesbelieve that we will continue to have access to capital resources through possible equity offerings, debt financing,financings, corporate collaborations,collaborations or other means. There can be no assurance that we will be able to obtain additional financing on terms acceptable to us, on a timely basis or at all. If we are unable to secure additional capital, it we may be required to curtail any clinical trials and development of new or existing products and take additional measures to reduce expenses in order to conserve our cash in amounts sufficient to sustain operations and meet our obligations. Based on our currentlycurrent anticipated level of expenditures, and after receiving the proceeds from the private placement in March 2024 and at-the-market public offering in November 2024, we believe that we have sufficient resources such that there is not substantial doubt about theour ability to continue operations for at least one year after the date that these financial statements are available to be issued.

-7272-- We anticipate that we will need to raise substantial additional capital, the requirements for which will depend on many factors, including:

-7777-- A change in the outcome of any of these or other variables with respect to the development of any of our current product candidates or future product candidates could significantly change the costs and timing associated with the development of that product candidate. Furthermore, our operating plans may change in the future, and we will continue to require additional capital to meet operational needs and capital requirements associated with such operating plans. If we raise additional funds by issuing equity securities, our stockholders may experience dilution. Any future debt financing into which we enter may impose upon us additional covenants that restrict our operations, including limitations on our ability to incur liens or additional debt, pay dividends, repurchase our common stock, make certain investments or engage in certain merger, consolidation,consolidation or asset sale transactions. Any debt financing or additional equity that we raise may contain terms that are not favorable to us or our stockholders.

Adequate funding may not be available to us on acceptable terms or at all. Our failure to raise capital as and when needed could have a negative impact on our financial condition and our ability to pursue our business strategies. If we are unable to raise additional funds when needed, we may be required to delay, reduce, or terminate some or all of our development programs and clinical trials or we may also be required to sell or license to others’others rights rights to our product candidates in certain territories or indications that we would prefer to develop and commercialize ourselves. If we are required to enter into collaborations and other arrangements to supplement our funds, we may have to give up certain rights that limit limit our ability to develop and commercialize our product candidates or may have other terms that are not favorable to us or our stockholders, which could materially affect our business and financial condition.

Net cash provided by financing activities was $45.1 $46.5 million forduring the year ended December 31, 2024 and was2025, due primarily to thesales privatemade placement financing agreement we closed on March 13, 2024 andunder the public offering sales agreement wewith closedGuggenheim onSecurities LLC dated November 13, 2024 ,as partially offsetamended by dividendsAmendment paidNo. to1 preferredthereto stockholders.dated November 14, 2025.

Net cash provided by financing activities was $27.5 $45.1 million forduring the year ended December 31, 20232024 and wasdue primarily due to the private placement financing agreement we closed signed on March 3,13, 2023.2024 and sales made under the sales agreement with Guggenheim Securities LLC dated November 13, 2024, partially offset by dividends paid to preferred stockholders.

Our financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”). The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. We consider our critical accounting policies and estimates to be related to revenue,debt and equity classification, warrant liabilities, research and development, and stock-based compensation, and warrant liabilities. The fair value of warrants contingently issued as part of our March 2023 private placement financing represents a material addition to our critical accounting policies and estimates.compensation. There have been no other material changes to our critical accounting policies and estimates during the the year ended December 31, 20242025 from those used for the year ended December 31, 2023.2024. The below policies represent our critical accounting policies.

In conjunction with the issuance of Series A-1 Preferred Stock in March 2023, and in conjunction with the issuance of Series B-1 Preferred Stock in March 2024, we initially account for the preferred stock as temporary,temporary or mezzanine,mezzanine equity. The Series A-1 and Series B-1 Preferred Stock do not fall within the scope of ASC 480, Distinguishing Liabilities from Equity, do not contain any embedded derivatives that require bifurcation, and are not classified as liabilities. However, as the Series A-1 and Series B-1 Preferred Stock, at issuance, are contingently redeemable upon the occurrence of an event that is not solely within our control, they are required to be initially classified as mezzanine equity and measured at the amount of net proceeds received. As the Series A-1 and Series B-1 Preferred Stock are not currently redeemable or probable of becoming redeemable, no subsequent remeasurement is required.

In conjunction with the issuance of Series A-1 Preferred Stock (see Note 10), we established a warrant liability as of March 3, 2023, representing the fair value of warrants that may be issued, subject to shareholder approval, upon conversion of the Series A-1 Preferred Stock. We account for these warrants as liabilities (in accordance with ASC 480480, Distinguishing Liabilities from Equity) on the balance sheets as a result of certain redemption clauses that are not within the control of the Company. The warrant liabilities are initially measured at fair value, resulting in an implied discount on the related preferred stock financing arrangement (recognized as a partial offset to the carrying value of the Series A-1 Preferred Stock), and are remeasured at fair value each reporting period. Changes in the fair value of the warrant liabilities are recognized in earnings during each period. The warrant liabilities are measured using Level 3 fair value inputs. See Note 1110 to our audited financial statements included elsewhere in this Annual Report on Form 10-K for a description of warrant liabilities and the related valuations.valuations

We account for stock-based compensation for all share-based payments made to employees and non-employees by estimating the fair value on the date of grant and recognizing compensation compensation expense over the requisite service period on a straight-line basis. We recognize forfeitures related to stock-based compensation as they occur. We estimate the fair value of stock options using the Black-Scholes option-pricing model. The Black-Scholes model requires the the input of subjective assumptions, including expected common stock volatility, expected dividend yield, expected term, risk-free interest rate, and the risk-free interestpublic rate.market closing price of the Company’s underlying common stock on the date of grant.

See the section titled “Summary of Significant Accounting Policies—Recent Accounting Pronouncements” in Note 2 to our audited financial statements included found elsewhere in this Annual Report on Form 10-K for aadditional description of recent accounting pronouncements applicable to our financial statements.information.

This Quarterly Report on Form 10-Q for the three-month six-month period ended MarchJune 31,30, 2026 contains “forward-looking statements” within the meaning of the Securities Act of 1933, as amended (the “Securities Act”), and the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These forward-looking statements contain information about our expectations, beliefs or intentions regarding our product development and commercialization efforts, business, financial condition, results of operations, strategies or prospects, and other similar matters. These forward-looking statements are based on management’s current expectations and assumptions about future events, which are inherently subject to uncertainties, risks and changes in circumstances that are difficult to predict. These statements may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “intends,” “estimates,” and other words of similar meaning.

Since our formation we have devoted substantially all of our resources to developing our product candidates. We have incurred significant operating losses to date. Our net incomeloss was $0.6 $5.9 million and our net loss was $12.8$14.6 million for the threesix months ended MarchJune 31,30, 2025 and 2026, respectively. As of MarchJune 31,30, 2026, we had an accumulated deficit of $140.6$142.4 million. We expect that our operating expenses will increase significantly as we advance our product candidates through pre-clinical and clinical development, seek regulatory approval, and prepare for and, if approved, proceed to commercialization; acquire, discover, validate, and develop additional product candidates; obtain, maintain, protect and enforce our intellectual property portfolio; and hire additional personnel.

We have funded our operations primarily from the sale and issuance of common stock, convertible promissory notes and from a loan, including cash and deferred salary from our Chief Executive Officer and principal stockholder.Officer.

Our ability to generate product revenue will depend on the successful development, regulatory approval and eventual commercialization of our current product candidates and future product candidates. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through private or public equity or debt financings,financing, collaborative or other arrangements with corporate sources, or through other sources of financing. Adequate funding may not be available to us on acceptable terms, or at all. If we fail to raise capital or enter into agreements to raise capital as and when needed, we may have to significantly delay, scale back or discontinue the development and commercialization of our current product candidates and future product candidates.

On October 28, 2025,we2025, we announced an update from our meeting with the U.S. Food and Drug Administration (FDA) and timing of the resubmission of our New Drug Application (NDA) for Oxylanthanum carbonate (OLC) following receipt of a CRL on June 30, 2025. The Type A FDA meeting was held to discuss the resolution of the single deficiency identified in the CRL related to the compliance status of a third-party manufacturing vendor. No other concerns have been identified to us, including pre-clinical, clinical, or safety data submitted as part of the NDA. Following receipt of the official meeting minutes from the Type A meeting and engaging in discussions with our third-party manufacturing vendor, we resubmitted our NDA to the FDA in December 2025. In January 2026, the FDA accepted the resubmission of the NDA for OLC, deeming the resubmission to be a Class II complete response which has a six-month review period from the date of resubmission, and set a PDUFA target action date of June 29, 2026.

Comparison of the Three Months Ended MarchJune 31, 30, 2025 and 2026 (in thousands)

Research and development expenses decreasedincreased by approximately $0.6$1.0 million, or 26%,59%, from approximately $2.2$1.8 million for the three months ended MarchJune 31,30, 20252025, to approximately $1.6$2.8 million for the three months ended March 31,June 30, 2026. This decreaseincrease was primarily driven by a reduction$0.9 million increase in drugnon-cash developmentstock-based costs of $0.5 millioncompensation, and consulting and professional fees and other expenses of $0.2 million, partially offset by an increase in laborconsulting and professional fees of $0.1 million and stock-based compensation of $0.1 million.

General and administrative expenses increased by $1.0$2.1 million, or 17%, 41%, from approximately $5.8$5.2 million for the three months ended MarchJune 31,30, 20252025, to approximately $6.8$7.4 million for the three months ended March 31,June 30, 2026. This increase was primarily driven by a $0.9$1.4 million increase in consultingnon-cash andstock-based professionalcompensation serviceas costs,well andas increases of $0.3 million in other labor andcosts. There was also an increase of $0.4 million related expenses.to Additionally,commercial rent,launch travel, supplies, and other costs decreased by $0.2 million, while stock-based compensation grew by $0.1 million.preparation.

Other income (expenses) decreasedincreased by $13.0$7.9 million, or 151%,1,531%, from an income of $8.6$0.5 million for the three months ended MarchJune 31,30, 2025, to expenseincome of $4.4$8.4 million for the three months ended MarchJune 31,30, 2026. This was primarily driven by a changedecrease of $7.6 million in the fair value of our warrant liability,liability partiallyas offsetwell byas aan decreaseincrease of earned$0.3 million in interest income during the year as a result of lower average cash balances available for interest-bearing accounts.income.

Since our formation through December 31, 2020, we have funded our operations with the sale of common and preferred stock, convertible notes and from a loan from our Chief Executive Officer and principal stockholder.Officer.

On November 13, 2024, wethe Company entered into a sales agreement, with Guggenheim Securities, LLC as amended by Amendment No. 1 thereto dated November 14, 2025 and further amended by Amendment No. 2 thereto dated June 5, 2026 (as amended, the “Sales Agreement”) pursuant to which, we may offer and sell shares of common stock having an aggregate offering price of up to $50.0$150.0 million, subject to certain limitations and in accordance with the terms of the sales agreement, from time to time through or to Guggenheim Securities, LLC acting as sales agent or principal. On November 14, 2025, the Company entered into an Amendment No. 1 to sales agreement with Guggenheim Securities LLC to increase the number of shares that may be sold under the sales agreement to $100,000,000 (collectively with the November 13, 2024 sales agreement, the “Sales Agreement”).

During the threesix months ended MarchJune 31,30, 2026, the Company sold 3,123,5375,278,767 shares of common stock pursuant to thea Salessales Agreement,agreement, with Guggenheim Securities, LLC, at an average price of $6.46$6.64 per share and paid $0.6 $1.1 million in commissions, resulting in net proceeds to the Company of approximately $19.6$34.0 million.

We have incurred net losses since our inception. For the threesix months ended MarchJune 31,30, 2026, we had a net loss of $12.8$14.6 million, and we expect to incur substantial additional losses in future periods. As of MarchJune 31,30, 2026, we had an accumulated deficit of $140.6$142.4 million.

We expect to continue incurring losses in the future and will be required to raise additional capital in the future to complete our clinical trials, pursue product development initiatives and penetrate markets for the sale of our products. We believe that we will continue to have access to capital resources through possible equity offerings, debt financings,financing, corporate collaborations or other means. There can be no assurance that we will be able to obtain additional financing on terms acceptable to us, on a timely basis or at all. If we are unable to secure additional capital, we may be required to curtail any clinical trials and development of new or existing products and take additional measures to reduce expenses in order to conserve our cash in amounts sufficient to sustain operations and meet our obligations. Based on our current level of expenditures, we believe that we have sufficient resources such that there is not substantial doubt about our ability to continue operations for at least one year after the date that these financial statements are available to be issued.

Net cash used in operating activities was $6.2 $13.8 million for the threesix months ended MarchJune 31,30, 2026. Cash used in operating activities was primarily due to the use of funds for development costs associated with our drug candidates, labor costs, consulting services, and other corporate expenditures for investor relations, compliance, and legal services. We incurred a net loss of $12.8$14.6 million after including the effect of non-cash adjustments for stock compensation and change in fair value of our warrant liability.

Net cash used in operating activities was $8.9 $17.3 million for the threesix months ended MarchJune 31,30, 2025. Cash used in operating activities was primarily due to the use of funds for development costs associated with our drug candidates, labor costs, consulting services, and other corporate expenditures for investor relations, compliance, and legal services. We reported net income of $0.6 million after including the effect of non-cash adjustments for stock compensation and change in fair value of our warrant liability.

Net cash used in investing activities was $5.2 million for the threesix months ended MarchJune 31,30, 20262026, and was due primarily to the purchase of marketable securities.

Net cash used in investing activities was $16,000 $22,000 for the threesix months ended MarchJune 31,30, 20252025, and was due to the purchase of furniturelab and fixtures for our corporate office.equipment.

Net cash provided by financing activities was $19.6 $34.0 million during the threesix months ended MarchJune 31,30, 2026, due primarily to sales made under the sales agreement with Guggenheim Securities LLC dated November 13, 20242024, as amended by Amendment No. 1 thereto dated November 14, 2025.2025 and further amended by Amendment No. 2 dated June 5, 2026.

Net cash provided by financing activities was $2.5 $13.5 million during the threesix months ended MarchJune 31,30, 20252025, due primarily to the privateat placementthe financingmarket public offering agreement we signed on March 13, 2025 and sales made under the sales agreement with Guggenheim Securities LLC dated November 13, 2024.

As of MarchJune 31,30, 20262026, and through the filing date of this Quarterly Report on Form 10-Q, we did not have during the periods presented, and we do not currently have any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.

Our financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”). The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. We consider our critical accounting policies and estimates to be related to debt and equity classification, warrant liabilities, research and development, and stock-based compensation. There have been no other material changes to our critical accounting policies and estimates during the threesix months ended March 31,June 30, 2026 from those used for the year ended December 31, 2025. The below policies represent our critical accounting policies.