Loading...
Loading...
Chat is set up on each filing report page.
Ask about this filing, its industry, or sector trends.
AI responses are generated from filing and peer context and may contain errors.
Item 1A. Risk Factors
Investing in our common stock involves a high degree of risk. For a detailed discussion of the risks and uncertainties related to our business, please refer to the section titled Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2024. There have been no material changes from the risk factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2024, except as set forth below.
Because our existing cash, cash equivalents,Healthcare and other reform legislation may increase the difficulty and investments will not be sufficientcost for us and any collaborators we may have to fund our operations, as currently planned, for more than one year beyoobtain marketing approval of and commercialize any product candidates we may develop and taffect the filing date ofprices we, or this Quarterly Report on Form 10-Q, we have determined that there is substantial doubt regarding our ability toey, may obtain.
In the United States and some foreign jurisdictions, there have been and continue as a to be ongoing concern.
Based on our existing cash, cash equivalents, short-term investments, and relateefforts to implement legislative and regulatory changes regarding the healthcare system. Such changes could party short-term investments asrevent or delay marketing approval of March 31, 2025, our current any product cand forecasted lidates that we may devel of operations and our forecasted cash flows, our ability to continue aop, restrict or regulate post-approval activities a going concern is dependent upon ond affect our ability to obtain the necessary financing to meet our obligations and repay our liabilities arisiprofitably sell any product candidates for which we obtain marketing from normal business operationsapproval. Although we cannot predict when they come due. We plan to provide at healthcare or other refor our capital requiremenm efforts will be successful, such efforts through financing or other transacmay result in more rigorous coverage criteria, in additions, and selling shares ofal downward pressure on the price that we, or our common stock under our at the market offering program. There can be no assurafuture collaborators, may receive for any approved products or in other consequences that we will be ablemay adversely affect our ability to raise additional capachieve or maintain profital to fund operations with terms acceptable to us, or at all. Because our existing cash, cash equivalents, and investbility.
Within the United States, the federal government and individual states have aggressively pursued healthcare reform, as evidenced by the passing of the Affordable Care Act, as aments will not be sufficient to fund our operations for moreded by the Health Care and Education Reconciliation Act of 2010 (the ACA), and the ongoing efforts to modify or repeal than one year from tt legislation. The date of issuance of ACA substantially changed the consolidated way healthcare is financial stateed by both governments appearingal and private in this Quarterly Report on Form 10-Q, we have determinedsurers and contains a number of provisions that there is substaaffect coverage and reimbursement of drug products and/or that could potential doubt regarding our ability to continuely reduce the demand for pharmaceutical products such as a goincreasing concern.
The substantial doubt about our ability to continue adrug rebates under state Medicaid programs for brand name prescription drugs a gond extending concern may adversely affect our stock pricethose rebates to Medicaid managed care and assessing a fee on manufacturers and our ability to raise capital. If we areimporters of brand name prescription drugs reimbursed unable to obtain additional capital, we may not be able to continue our operationder certain government programs, including Medicare and Medicaid. Other aspects on the scope or scalef healthcare reform, such as currexpanded governmently conducted, enforcement authority and heightened standards that could have a material adverse eincrease compliance-related costs, could also affect on our business, results of operat. Modifications have been implemented under the former Trump administrations and financial condiadditional modification.
Disruptions at ts or repeal may occur.
The FDA and othercontinuing efforts of the government agencies caus, insurance companies, managed by reduction in staffing, funding shortagecare organizations and other payers or global f health concerns could hinder their ability to hire, retain or deploy key leadershipcare services to contain or reduce costs of healthcare may adversely affect:
the demand for and othey of our personnel, or oroduct candidates, if approved;
34
therwise prevent new ability to set a price that we believe is fair for modified any of our products from being d candidates, if approved;
our ability to generate reveloped, approved,nues and achieve or commercialized in a timely manner or at all, which could negmaintain profitability;
the level of taxes that we are required to pay; and
the availability of capital.
Legislatively impact our business.
Currently, feder and regulatory proposals have been made to expand post-approval agencies in the U.S. are operating under a continuing resolution that is set to expire on September 30, 2025. Without approprirequirements and restrict sales and promotional activities for pharmaceutical and biologic products. We cannot be sure whether additional legislative changes will be enacted, or whether FDA regulation of addits, guidance or interpretational funding to federal agencies, our business operations related tos will be changed, or what the impact of such changes on the marketing approvals of our product development activities forcandidates, if any, may be. In addition, increased scrutiny by Congress of the U.S. market could be impacted. Inadequate fundFDAs approval process may significantly delay or prevent marketing approval, as well as subject us to more stringent product labeling for the FDA, the SEC and post-marketing testing and other governrequirement agenciess.
Moreover, includreasing from efforts by government shut downs, or oal and third-party payors in ther disruptions to these agencies operations, could hinder their ability to hi United States and abroad to cap or reduce healthcare and retain key leadershipcosts may cause such organizations to limit both coverage and other personnel, preve level of reimbursement for new prodly approved products and services from being developed, as a result, they may not cover or commercialized in a timely manner provide adequate payment for otherwiseur prevent those agencies from peroduct candidates. There has been increasing legislative and enforming normal business functions on which the operation of our business may rely, which could negatively impact our business. The Trump administration has issucement interest in the United States with respect to specialty drug pricing practices. Specifically, there have been several recent U.S. Congressional inquiries and proposed and enacted federal and state legislation designed executive orders seekingto, among other things, bring more transparency to greatlydrug pricing, reduce the sizecost of the federal workforce, includprescription drugs under Medicare, review the relationship between pricing through layoffsand manufacturer patient programs, and sereform goverance packages offered to enment program reimbursement methodologies for drugs. For examployees of federal agencies withe, the Inflation Reduction Act of 2022 (the IRA) that was signed into law in the executive branch andAugust 2022, contains several provisions that are indepetendent agencied to limit prices of pharmaceutical and biologic products, including the FDA. Any such reduction in personnel may result in longer review times by the FDA and othcreating a $2,000 out-of-pocket cap for Medicare Part D beneficiaries, imposing new manufacturer agefinancies.
The al liability of the FDA to review and approve new products can be affected by a variety of factors, includn all drugs in Medicare Part D, allowing the U.S. government to negotiate Medicare Part B and Part D pricing government budgetfor certain high-cost pharmaceutical and funding levels, statutory, regulatory, and policy changes, the FDAs abilitybiologic drugs without generic or biosimilar competition, requiring companies to pay rebates to hiMedicare and retain key personnelfor drug prices that increase faster than inflation, and accept delaying until January 1, 2032the payimplementation of user fees,the U.S. Department of Health and other events that may otherwise affectHuman Services (HHS) rebate rule that would have limited the FDAs ability to perform routine functions. Average fees that pharmacy benefit managers can charge. Further, under the IRA, orphan drugs were preview times atously exempted from the agency have fluctuated in recent years Medicare drug price negotiation program; however, this exemption was a result. In
33
atricted to ddition, government funding of orugs with only one orphan designation and for which ther government agencies only approved indication is for that fund redisearch and development activities is subject to the political process, which is inherently fluid and unpredictable. Disruse or condition. If a product received multiple orphan designations or had multiple approved indications, it would not qualify for the orphan drug exemptions and personnel turnover, as a resul. Under the One Big Beautiful Bill Act of leadership changes, staff redu2025, this restriction was eliminated; and effections ve for otherwise, at the FDA and other agencies may also slow 2028 initial price applicability year, all orphan drugs, regardless of the time necessary for biologicnumber of orphan designations or modifiindications to approved biologics to be reviewed, are exempt from the Medicare drug price negotiation program. The effects of the IRA on our business and/or approved by necessa the healthcare industry government agencies, which would adversely affect our business. Changes and cuts in FDA staffing also could resultin general is not yet known.
On April 15, 2025, the Trump Administration published Executive Order 14273, Lowering Drug Prices by Once Again Putting Americans First, which generally directs the HHS to take measures to reduce drug prices, in delays including eliminating the FDAs responsiveness or in its ability to review IND submissions or applicaso-called pill penalty under the IRA that creates a distinctions, issue regulations between small molecule and large molecule products for guidance, or implement or enforce regulatory requirements in a timely fashion or at all.
Over the last sepurposes of determining when a drug may be eligible for drug price negotiation. On May 12, 2025, the Trump Administration published Executive Order 14297, Deliveral years, the U.S. governming Most-Favored-Nation Prescription Drug Pricing to American Patient has shut down seves which general times andly, among other things, directs certain regulatory agencies, such aexecutive officials to establish and communicate most-favored-nation price targets the FDA, have hado pharmaceutical manufacturers to furlough critical employees and stop critical acbring prices for American patients in line with comparably developed nations. Further, the Executivities. If a prolongede Order directs the federal government shutdown occurs, or if staffing changto support regulatory paths to allow direct-to-patient sales for companies preventhat meet the FDA or other regulatory authorities from conductse targets. It also states that the Administration will take additional aggressive action (for example, examining whetheir regular inspections,r marketing approvals should be modified or reviews,scinded or opening ther regulatory activities, including formal and informal interac door for individual drug importation waivers) should manufacturers fail to offer American consumers the most-favored-nations with lowest product developers, it could significantly impact thice. It also directs the Secretary of Commerce and the U.S. Trade Representative to take ability of the FDA or other regulatorll necessary and appropriate action to ensure foreign countries are not engaged in any authorities to timely review and process our future regulatory submissions, which could have a materict, policy, or practice that may be unreasonable or discriminatory or that may impair United States national security . . . including by suppressing the price of pharmaceutical adverse effect on our business.
Unfavorproducts below fair market value in foreign countries. Notable macroeconomic conditions oy, a similar Most Favored Nation pricing rule enacted under the first
35
Tr market volatilityump Administration was subject to an injunction resulting from geopolitical developments or najudicial challenges to the rule, which was formally rescinded by the former Biden Administration in August 2021.
In additional or global economic condit, at the state level, legislatures have increasingly passed legislation and implemented regulations, including t similar to those affecting tunder consideration at the financial services industry,ederal level, as well as laws designed to could adversely affect our business, financial conditionntrol pharmaceutical and biotherapeutic product pricing, including restrictions on pricing or results of operations.
Adimbursement at the state goverse macroeconomic conditions or nment level, limitations on discounts to patients, market volatility resulting from ning cost disclosure and transparency measures, restrictions or other limitational or global economic developmentss on patient assistance, and, in some cases, political unrest, high inflation, ricies to encourage importation from other countries (subject to federal approval) and bulk purchasing interest r. Certain states, new or increase international tariff are also pursuing cost containment efforts through Prescription Drug Affordability Boards and retaliatory tariffs, changes in international trade relationships asimilar entities.
We expect that the healthcare reform measures that have been adopted and may be adopted in the future may result in more rigorous coverage criteria and military conflicts, such asin additional downward pressure on the price the ongoingat we receive for any approved product and conflict between Russia and Ukraine, uld seriously harm our future revenues. We cannot be sure whethe potentir additional for significantlegislative changes in U.S. policieswill be enacted, or rwhether FDA regulatory environmentions, guidance or interpretations will be changed, or other fwhat the impactors, could materially and adversely affect of such changes on the marketing approvals of our business operations. Sanctions imposed by the U.S. and other countries in products and future product candidates, if any, may be. In addition, increased scrutiny by Congresponse to such conflictss of the FDAs approval process may also continue to adversely impasignificantly delay or prevent marketing approval, as well as subject the financial us to more stringent product labeling and post-marketsing testing and othe global economy, and ar requirements. Any economic countermeasureduction in reimbursement from Medicare or other government programs may res by tult in a similar reduction in payments from private payors. The affectedimplementation of cost countriesntainment measures or others could exacerbate healthcare reforms market and economic insy prevent us from being able to generate revenue, attain profitability. Tariffs levied by t or commercialize our products.
The U.S. and oCongress, ther countries also Trump administration, or any new administration may make substantial changes to fiscal, tax, and other federal policies that may adversely affect financial markets and the globour business.
Since the start of the Trump Administration in 2025, U.S. policy changes have been implemented at a rapid pace and additional economchanges are likely. For example, on April 2, 2025, tthe U.S. government has adopted new approaches to trade policy and in some cases may renegotiate, or potentially terminate, certain existing bilateral or multi-lateral trade agreements. The U.S. government has also imposed substantial tariffs on most countries throughout the world. The new U.S. administration has and has further threatened to continue to broadly impose tariffs, which could lead to corresponding punitive actions by the countries with which the U.S. trades.
Additionally, While certain tariffs have subsequently been suspended, modified or temporarily reduced, we cannot predict the results of the U.S. governments trade negotiations or the outcome of ongoing legal challenges to pspecific tariff policies. Changes to U.S. policy implemented by the U.S. Congress, the Trump administration or any new administration have impacted and may in the future impact, among other things, the U.S. and global economy, international trade relations, unemployment, immigration, healthcare, taxation, the U.S. regulatory environment, inflation and other areas. ThereAlthough we can be no assurancenot predict the impact, if any, of these changes to our business, that further deterioration in creditey could adversely affect our business. Until we know what policy changes are made, whether those policy changes are challenged and financial marketssubsequently upheld by the court system and how those changes impact our business and confidence the business of our competitors over the long term, we will not know if, overall, we will benefit from them or be negatively affected by them.
Changes in economictax laws or in their implementation or interpretation may adversely affect our business and financial conditions will not occur. For in.
The rules dealing with U.S. federal, stance, actual eventte and local income taxation are constantly under review by persons involving limited liquidity, defaults, non-performance or oed in the legislative process and by the Internal Revenue Service, the U.S. Treasury Department and non-U.S. taxing authorities. For example, the One Big Beautiful Bill Act (the OBBBA) was signed into law on July 4, 2025 and made significant changes to U.S. federal tax law. Changes to tax laws (which changes may have retroactive application) could adversely affect our business and our financial condition. For example, under Section 174 of ther adverse de Internal Revenue Code of 1986, as amended, in taxable years beginning after December 31, 2021, expenses that are incurred for research and developments performed outside that ae U.S. will be capitalized and amortized, which may have an adverse effect financial institutions, transaon our cash flow. The OBBBA provides that for taxable years beginning after December 31, 2024, expenses that are incurred for research and development performed in the U.S. may, at the taxpayers electional counterparties or o, be immediately deducted or capitalized and amortized. In addition, ther companies in the financi OBBBA provides that for taxable years beginning after December 31, 2021 and before January 1, 2025, certain eligible taxpayers generally may elect to
36
retroal services industry octively deduct expenses for research and development performed in the U.S. in such taxable years by filing amended tax returns for such taxable years, and all other the financial services industryaxpayers that are not eligible to make such an election and that amortized expenses for research and development performed in the U.S. in such taxable years generally, or concerns or ru may elect to accelerate and deduct the remaining unamors about any tized amounts of such research and devents of lopment expenses (i) in these kinds first taxable year beginning after December 31, 2024, or o(ii) ratably over ther simil two-taxable year period beginning with the first taxable year risks, habeginning after December 31, 2024. In recent years, many such changes have in the past and may in tbeen made and changes are likely to continue to occur in the future lead to market-wide liquidity . We cannot predict whether, when, in what form or with what effective dates, tax laws, regulations and rulings may be enacted, problems. Investmulgated or decided or concerns regarding whether they could increase our tax liability or require changes in the U.S. omanner international financial systems could result which we operate in order to minimize increases in our tax liability.
Our future success depends on our ability to retain less favorable commercial financing terms, including higherour key employees and to attract, retain and motivate qualified personnel.
We are highly dependent on our key executives and other principal members of our management, scientific and clinical team. Although we have entered interest rates or costs and tigho employment agreements and/or offer letters with our executive officers, they are engaged at will, meaning we or they may ter fminancialte the relationship at and operating covenants,y time. We do not maintain key person insurance for any of our executives or systemic limitations on access to creditother employees. The loss of the services of any of these persons could impede the achievement of our research, development and commercialization objectives.
Recruiting and liquidity sources, thereby makretaining qualified scientific, clinical, manufacturing and sales and marketing it more difficult for us to acquipersonnel will also be critical to our success. In addition, our company-building efforts and establishment of a company culture financing on acceptwill also be important to developing an innovative company in a high-evolving area. We may not be able terms or at all. In addition, any further deterioration io succeed in these efforts to build Prime Medicine as an attractive and exciting place to build a career or to attract and retain these types of personnel on acceptable terms given the macroeconomic economy competition among numerous pharmaceutical and biotechnology companies for similar personnel. We also experience competition for financithe hiring of scientific and clinical servicpersonnel from universities industry could lead to losses or defaults by our suppliers, which in turn, could have a mateand research institutions. In addition, we rely on consultants and advisors, including scientific and clinical advisors, to assist us in formulating our research and development and commercialization strategy. Our consultants and advisors, may be employed by employers other than us and may have commitments under consulting or advisory contracts with other entities that may limit their availability to us. The inability to recruit, or loss of services of, certain executives, key employees, consultants or advisors, may impede the progress of our research, development and commercialization objectives and have a material adverse effect on our current and/or planned business operatibusiness, financial condition, results of operations and prospects.
To motivate and retain qualified employees, executive officers and directors who we believe best represent our Company values and can make meaningful contributions and towards achieving our current or projected purpose of delivering a new class of differentiated one-time curative genetic therapies to addresults s the widest spectrum of operadiseases by deploying our Prime Editing technology, in additions to salary and financial conditcash incentives, as applicable, we have provided stock option. For exas that vest over time. The value to emple, there has been proposed U.S. legisloyees and directors of stock options that vest over time may be significantly affected by movements in our stock price that are beyond our control and may at any time be insufficient to counteract more lucration that may restve offers from other companies. To the extent our stock prict the e declines, our ability of U.S. biopharmato incentivize, retain or attract qualified talent could be negatively impacted. For example, in recent years, the stock market in general, and the market for pharmaceutical coand biotechnology companies to purcin particular, hase services or experienced extreme products from,ice and volume fluctuations, often unrelated or otherwise collaborate with, certain Chinese disproportionate to changes in the operating performance of the affected companies. As a biotechnology companiesy, the market price of concern without losour common stock has historically been volatile, reflecting the ability to contrarisks and uncertainties inherent in the development of product with, or otherwise receive funding from, the U.S. government. We continue candidates. Since 2024, the market price of our common stock has experienced material fluctuations and declined from a high of approximately $9.39 on February 27, 2024 to a low of approximately $1.15 on April 8, 2025. As a result, certain of our employees and directors now hold options with exercise prices meaningfully above the recent trading range of our common stock (often referred to assess the legislation as it develops to determine whe underwater or out-of-the-money), rendering the options a less effective means of incentivizing and retaining such holders.
We also recently announced a strategic restructuring, including ther it could have an effect o deprioritization of our CGD programs, as well as a cost and workforce reduction to focus on our contractuliver franchise and programs funded through external relapartnerships, placing additionshipsal pressure on the retention of qualified talent. Also, cuthough we continue to believe that stock options
37
arre an important component inflatof the Companys compensation program, underwater optionars may be perceived by trends in the global economy may impacheir holders as having little or no incentive or retention value due to the disparity between the exercise prices and the current salaries and wages, costs of goodtock price. To provide added incentives to retain and motivate key contributors and to improve morale among our employees and transportatidirectors to ensure alignment and motivation expenses, amonto execute on the Companys reprioritized strategy, our stockholders approved a one-time repricing other thf certain outstandings, and recent and potent stock options that have been granted under our 2019 Stock Option and Grant Plan and/or the 2022 Stock Option and Incentive Plan at the special future disruptions in access to bank deposits or lemeeting of stockholders held on August 1, 2025. Despite this, we may have difficulty retaining key personnel, which could adversely affect our business and further development of our product candingdates.
If commitments due to bank failurnflicts arise between us and our collaborators or strategic partners, these parties may create market act in a manner adverse to us and economic instcould limit our ability.
34
A severe or prolongeto implement our strategies or we could lose license rights that are important to our business.
We are and economic downturn or additional global financial cxpect to continue to be reliant upon certain patent rights and proprietary technology we have licensed from third parties that may be important or necessary to the development of our Prime Editing technology and product candidates. If conflicts arises could result between our corporate or academic collaborators or strategic partners and us, the other party may act in a variemanner adverse to us and could limit our ability of risks to oto implement our strategies or we could lose license rights that are important to our business, including weakened demand for. For instance, we have entered into license and collaboration agreements with Beam and Broad Institute related to the research, development, delivery, manufacturing, any d commercialization of Prime Editing technology and certain product candidates we may develop or our ability to raise additional capital when needed on acceptable terms, if at all.
Further, U.S. governme.
The agreements under which we currently license intellectual property rights from Beam and Broad Institute are complex, and certain provisions in such agreements may be susceptible to multiple interpretations. The resolution of any contract interpretation disagreement that may arise under our existing license agreements or future license agreements into which we may enter could narrow what we believe to be the scope of our rights to the relevant appintellectual propriations haerty or technology or broaden what we believe been affected by larger U.S. government budgetary issues and to be the scope of the licensors rights to our intellectual property and technology, or increase what we believe to be our financial or other obligations under the related legislation. In addevant agreement, any of which could have a material adverse effect on our business, financial condition, in the past, U.S. debt ceilingresults of operations and prospects. For example, we have exclusively licensed and budget deficit concerns have increased sublicensed certain of our owned and licensed intellectual property rights to Beam pursuant to a license and collaboration agreement, or the possibility of additional credit-rating downgrades Beam Collaboration Agreement, in certain fields. The parties have presented differing contractual interpretations, the resolution of which could expand economic slowdowns, or a recession in the U.S. Although U.S. lawmakers passed legislatthe field of exclusivity or other rights that we believe were granted to Beam and therefore, narrow what we believe to be our field of exclusivity or rights with respect to such licensed intellectual property rights.
For example, we are currently engaged in arbitration to raise the federal debt ceilproceedings with Beam regarding the Beam Collaboration Agreement. A dispute arose between the parties following on multiple occasions, ratur March 18, 2025 announcement that we are developing a Prime Editing-based treatment for AATD. On April 16, 2025, Beam filed an arbitration demand with the American Arbitration Association, or the AAA, allegings agencies that we have lowered obreached the Beam Collaboration Agreement by developing a product for the treatened to lower the long-term sovereign credit ment of AATD and by allegedly not complying with certain obligations to transfer technical information to Beam pursuant to the Beam Collaboration Agreement. On April 18, 2025, we filed an arbitrating on the U.S. Ton demand with the impact ofAAA seeking a declaration that our AATD program is or any furwithin our Field as defined by ther downgrades to the U.S. governments sovereign credit rating o Beam Collaboration Agreement. The arbitrations have been consolidated, and the consolidated proceeding remains in its early stages. If the final resolution of the matter its perceived creditwors adverse to us, the arbitration panel may provide Beam with relief including, among other thiness could adversely affect the U.S. and global financialgs, monetary damages and/or an order that we cease work on our AATD program and transfer such program to Beam. Such a relief could have a markets and economic condterial adverse effect on our competitive positions. As a , business, financial condition, result, government s of operations and growth prospendicts.
Our strategic restructuring levels are difficand the associated workforce reduction announced in May 2025 may not result to predict beyoin anticipated cost savings, could result in total costs and the neaexpenses that are greater term due to numerous factorshan expected and could disrupt our business.
In May 2025, we announced a strategic restructuring, including the external deprioritization of our CGD programs, to focus on our liver franchise and programs funded threat environment, future government ough external pipelines. The strategic restructuring includes cost reduction measures and reduction of our organizational headcount by approximately 25%, which are designed to
38
significantly decrease our opriorities and the sterating expenses and cash burn, reducing anticipated cash needs by almost half through 2027. The estimates of government finances. Significant changes in government spending the charges and cash expenditures that we expect to incur in connection with the strategic restructuring and related workforce reduction, and the timing thereof, are subject to a number of assumptions, and we may incur costs that are greater than we currently expect. We may not realize, in full or changes in U.S. gin part, the anticipated benefits, savings and improvernment priorities, polics in our operating structure from our new strategic efforts due to unforeseen difficulties and requirements, delays or unexpected could have a materists. If we are unable to realize the expected operational adverse effect onefficiencies and cost savings from the strategic restructuring, our results of operations, and financial condition or liquidity.
Any of twould be adversely affected. We also cannot guarantee that we will not have to undertake additional workforce reductions or related activities in the foregoing could harmuture. Such cost reduction efforts may in the future adversely affect our ability to attract and retain employees, and may adversely affect our culture and impact our busability to effectively pursue our business and we cannot anticipate all of strategy. Furthermore, our strategic restructuring may be disruptive to our operations. For example, our workforce reductions could yield unanticipated consequences, such as attrition beyond planned staff reductions, increased difficulties in our day-to-day operations and reduced employee morale. If employees who were not affected by the ways reduction in force seek alternate employment, this could result in us seeking contract support which the current economic climatemay result in unplanned additional expense or harm our productivity. Our workforce reductions could also harm our ability to attract and retain qualified management, scientific, and financiclinical personnel who are critical market conditionsto our business. Any failure to attract or retain qualified personnel could adversely impactprevent us from successfully developing our business.product candidates in the future.