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SION on Nasdaq

Sionna Therapeutics, Inc.

American pharmaceutical preparations company, incorporated in Delaware1

In its 2026 annual report the company says: “We are a clinical-stage biopharmaceutical company on a mission to revolutionize the current treatment paradigm for cystic fibrosis by developing novel medicines that normalize the function of the cystic fibrosis transmembrane conductance regulator protein to deliver clinically meaningful benefit to people with CF.”3 It is headquartered in Waltham, Massachusetts.1

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Last updated Oct 21, 2026.

Overview

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  • TickerSION on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersWaltham, Massachusetts1
  • Incorporated inDE2
  • Business address21 Hickory Drive, Suite 500, Waltham, Ma 024512
  • Filer category, Emerging growth company2

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We are a clinical-stage biopharmaceutical company on a mission to revolutionize the current treatment paradigm for cystic fibrosis (“CF”) by developing novel medicines that normalize the function of the cystic fibrosis transmembrane conductance regulator (“CFTR”) protein to deliver clinically meaningful benefit to people with CF. CF is a progressive and life-threatening genetic disease caused by inherited mutations in the CFTR gene, which lead to insufficient CFTR function. While advances in the discovery and development of CFTR modulators have significantly improved the lives of people with CF, at least two-thirds of patients on the current standard of care do not have normal CFTR function, defined as sweat chloride levels below 30 mmol/L. Patients with reduced CFTR function can experience debilitating multi-system complications that lead to significantly impaired quality of life and sh…3 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Financial statements

Operating income4-$89.0M in 2025+26% since 2024
-$100.0M-$75.0M-$50.0M-$25.0M02024: -$70.6M-$70.6M20242025: -$89.0M-$89.0M2025+26%
Net income4-$75.3M in 2025+22% since 2024
-$80.0M-$60.0M-$40.0M-$20.0M02024: -$61.7M-$61.7M20242025: -$75.3M-$75.3M2025+22%

Every line of the income statement as filed: the last 2 fiscal years, latest first.4

Period ending2025-12-312024-12-31
Research and development$60.3M$57.3M
General and administrative$28.7M$13.3M
Total operating expenses$89.0M$70.6M
Loss from operations-$89.0M-$70.6M
Interest income$13.3M$8.2M
Other income$419.0K$698.0K
Total other income$13.7M$8.9M
Net loss-$75.3M-$61.7M
Net loss per share, basic (in dollars per share)-$1.88-$15.99
Net loss per share, diluted (in dollars per share)-$1.88-$15.99
Weighted-average common shares outstanding, basic (in shares)40.0M shares3.9M shares
Weighted-average common shares outstanding, diluted (in shares)40.0M shares3.9M shares
Unrealized gain on marketable securities$172.0K$368.0K
Total other comprehensive gain$172.0K$368.0K
Comprehensive loss-$75.1M-$61.3M

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Corporate structure

Sionna Therapeutics, Inc. sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Sionna Therapeutics, Inc.

  • RA CAPITAL MANAGEMENT, L.P. Filed SCHEDULE 13D/A on Sionna Therapeutics, Inc., latest Sep 21, 2026 (3 filings since Feb 18, 2025)
  • VIKING GLOBAL INVESTORS LP Filed SCHEDULE 13G/A on Sionna Therapeutics, Inc., latest May 15, 2026 (2 filings since Feb 14, 2025)
  • Qatar Investment Authority Filed SCHEDULE 13G/A on Sionna Therapeutics, Inc., latest May 12, 2026 (2 filings since Jun 16, 2025)
  • ORBIMED ADVISORS LLC Filed SCHEDULE 13D/A on Sionna Therapeutics, Inc., latest Apr 20, 2026 (2 filings since Feb 13, 2025)
  • JPMorgan Chase Filed SCHEDULE 13G/A on Sionna Therapeutics, Inc., latest Oct 31, 2025 (2 filings since Jul 30, 2025)
  • Atlas Venture Fund XI, L.P. Filed SCHEDULE 13D/A on Sionna Therapeutics, Inc., latest Oct 20, 2025 (2 filings since Feb 18, 2025)
  • Enavate Sciences GP, LLC Filed SCHEDULE 13D on Sionna Therapeutics, Inc., latest Feb 18, 2025
  • TPG GP A, LLC Filed SCHEDULE 13D on Sionna Therapeutics, Inc., latest Feb 18, 2025
  • Sionna Therapeutics, Inc. Waltham, Massachusetts

Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Sionna Therapeutics, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$4.3M4 Dec 31, 2025$4.0M4 Dec 31, 2024+7.7%
Accumulated depreciation$2.1M4 Dec 31, 2025$1.6M4 Dec 31, 2024+35.1%
Property and equipment, net$2.2M4 Dec 31, 2025$2.5M4 Dec 31, 2024−9.8%
Operating-lease assets (leased space)$6.9M4 Dec 31, 2025$7.8M4 Dec 31, 2024−11.6%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$58.5M4 Dec 31, 2025$37.8M4 Dec 31, 2024+54.7%

Properties, in its own words

Our principal facilities consist of office and laboratory space. Our corporate headquarters is located in Waltham, Massachusetts, where we occupy approximately 24,051 square feet of office space at 21 Hickory Drive, Suite 500, Waltham, Massachusetts 02451. The current term of our lease expires in November 2030. We have the option to extend our lease for an additional five-year term at market-based rates.

We believe these facilities are adequate for the foreseeable future and that suitable additional space will be available as and when needed. To meet the future needs of our business, we may lease additional or alternate space. We believe that suitable additional or substitute space at commercially reasonable terms will be available as needed to accommodate any future expansion of our operations.

Item 2 of the 10-K filed Mar 2, 2026.3

Leadership

Who has led Sionna Therapeutics, Inc., and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Michael Cloonan2025–now

President

  1. Michael Cloonan2025–now

Chief financial officer

  1. Elena Ridloff2025–now
Board members and other officers (14)

Timeline

  1. Sep 14, 20268-K Exit or restructuring costs; Executive or director change; Other events21
  2. Aug 10, 20268-K Other events22
  3. Aug 6, 20268-K Results of operations23
  4. Jun 18, 20268-K Shareholder vote24
  5. May 12, 20268-K Results of operations25
  6. Mar 2, 20268-K Results of operations26
  7. Nov 5, 20258-K Results of operations27
  8. Aug 11, 20258-K Results of operations28
  9. Jun 13, 20258-K Shareholder vote29
  10. Jun 4, 20258-K Regulation FD disclosure30
  11. May 12, 20258-K Results of operations31
  12. Mar 20, 20258-K Results of operations32
  13. Feb 6, 2025New chief executive Michael Cloonan becomes CEO7

Calendar

Coming up

  1. Nov 4, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.46) a share, on Nov 5, 2025.33

When it reported results

  1. Aug 6, 2026Reported quarterly or annual results23
  2. May 12, 2026Reported quarterly or annual results25
  3. Mar 2, 2026Reported quarterly or annual results26
  4. Nov 5, 2025Reported quarterly or annual results27
  5. Aug 11, 2025Reported quarterly or annual results28
  6. May 12, 2025Reported quarterly or annual results31
  7. Mar 20, 2025Reported quarterly or annual results32

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

231 filings to the SEC since October 2021: 2 annual reports, 5 quarterly reports, 13 major events, 100 insider forms, 15 large holders, 96 other. The latest 20:

  1. Sep 21, 2026SCHEDULE 13D/A EDGAR
  2. Sep 21, 20264 EDGAR
  3. Sep 18, 20264 PRIMARY DOCUMENT EDGAR
  4. Sep 18, 20264 PRIMARY DOCUMENT EDGAR
  5. Sep 18, 20264 PRIMARY DOCUMENT EDGAR
  6. Sep 18, 20264 PRIMARY DOCUMENT EDGAR
  7. Sep 17, 2026144 EDGAR
  8. Sep 14, 20268-K EDGAR
  9. Aug 10, 20268-K EDGAR
  10. Aug 6, 202610-Q EDGAR
  11. Aug 6, 20268-K EDGAR
  12. Jul 9, 20264 EDGAR
  13. Jul 9, 20264 EDGAR
  14. Jul 7, 20264 PRIMARY DOCUMENT EDGAR
  15. Jul 6, 2026144 EDGAR
  16. Jul 2, 20264 EDGAR
  17. Jul 2, 20264 EDGAR
  18. Jun 18, 20264 PRIMARY DOCUMENT EDGAR
  19. Jun 18, 20264 PRIMARY DOCUMENT EDGAR
  20. Jun 18, 20264 PRIMARY DOCUMENT EDGAR

The 231 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

88 open-market trades by officers, directors and large owners since October 2021: 7 buys and 81 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 17, 2026RA CAPITAL MANAGEMENT, L.P.DirectorSale3,448,811$6.33$21.8MForm 4
Jul 7, 2026Thompson Peter A.DirectorSale85,918$44.86$3.9MForm 4
Jul 7, 2026OrbiMed Capital GP VIII LLCDirectorSale85,918$44.86$3.9MForm 4
Jul 6, 2026Fitzpatrick JenniferCLO and Head of Program Mgmt.Sale10,250$43.60$446.9KForm 4
Jun 30, 2026Thompson Peter A.DirectorSale115,844$45.50$5.3MForm 4
Jun 30, 2026ORBIMED ADVISORS LLCDirectorSale115,844$45.50$5.3MForm 4
May 27, 2026Thompson Peter A.DirectorSale101$44.49$4.5KForm 4
May 27, 2026ORBIMED ADVISORS LLCDirectorSale101$44.49$4.5KForm 4
May 11, 2026Thompson Peter A.DirectorSale184,639$46.22$8.5MForm 4
May 11, 2026ORBIMED ADVISORS LLCDirectorSale184,639$46.22$8.5MForm 4
May 8, 2026Thompson Peter A.DirectorSale59,767$44.58$2.7MForm 4
May 8, 2026ORBIMED ADVISORS LLCDirectorSale59,767$44.58$2.7MForm 4
May 7, 2026Thompson Peter A.DirectorSale48,546$44.61$2.2MForm 4
May 7, 2026ORBIMED ADVISORS LLCDirectorSale48,546$44.61$2.2MForm 4
Apr 18, 2026Thompson Peter A.DirectorSale2,948$44.52$131.2KForm 4
Apr 18, 2026ORBIMED ADVISORS LLCDirectorSale2,948$44.52$131.2KForm 4
Apr 17, 2026Thompson Peter A.DirectorSale52,397$44.68$2.3MForm 4
Apr 17, 2026ORBIMED ADVISORS LLCDirectorSale52,397$44.68$2.3MForm 4
Apr 16, 2026Thompson Peter A.DirectorSale226,906$45.34$10.3MForm 4
Apr 16, 2026ORBIMED ADVISORS LLCDirectorSale226,906$45.34$10.3MForm 4

All 88 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Michael CloonanM.B.A.55$646.6K$7.0M42
2025Caroline Stark BeerM.B.A.47$158.9K$5.6M42
2025Elena RidloffC.F.A.46$506.7K$2.9M42
2024President and Chief Executive Officer$506.2K$3.7M42
2024Chief Financial Officer$449.9K$1.3M42

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Ra Capital Management, L.P.9,905,045$435.7M3.8%No change
Tpg Gp A, LLC6,494,962$285.7M5.7%No change
Viking Global Investors LP3,195,181$140.6M0.4%No change
Atlas Venture Life Science Advisors, LLC2,995,602$131.8M15.0%No change
Orbimed Advisors LLC2,555,877$112.4M2.1%−974,825
Enavate Sciences Gp, LLC2,478,030$109.0M31.6%No change
Adage Capital Partners Gp, L.l.c.1,600,000$70.4M0.1%+1,450,000
BlackRock, Inc.1,474,769$64.9M0.0%+178,902
Jpmorgan Chase & Co1,490,508$64.1M0.0%+25,494
Jennison Associates LLC1,172,133$51.6M0.0%−279,087
Citadel Advisors LLC1,147,636$50.5M0.0%−19,295
Vanguard Capital Management LLC1,132,001$49.8M0.0%+102,504
State Street Corp1,021,534$44.9M0.0%+265,307
Perceptive Advisors LLC905,000$39.8M0.6%+246,561
Deerfield Management Company, L.P.680,916$30.0M0.4%−289,674
Siren, L.L.C.610,515$26.9M0.5%+310,515
Eventide Asset Management, LLC474,981$20.9M0.3%−170,549
Geode Capital Management, LLC457,145$20.1M0.0%+67,273
Baker Bros. Advisors LP400,000$17.6M0.1%No change
Casdin Capital, LLC400,000$17.6M0.9%New
Kalehua Capital Management LLC394,144$17.3M5.5%No change
Goldman Sachs Group Inc388,810$17.1M0.0%+125,636
Driehaus Capital Management LLC385,447$17.0M0.1%+308,814
Franklin Resources Inc290,113$12.8M0.0%+114,630
Aberdeen Group plc284,138$12.5M0.0%−280,037

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How Sionna Therapeutics, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARSionna Therapeutics, Inc.1
  • CIK0002036042
  • Employer ID (EIN)84-28015213
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company3
  • Incorporated inDelaware3
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address21 Hickory Drive, Suite 500, Waltham, MA 024511
  • Phone617-819-20201
  • Shares outstanding45,212,399 as of Jul 31, 20266
  • Public float$342.0M as of Jun 30, 20253
  • AuditorDeloitte & Touche LLP, Boston, Massachusetts PCAOB ID 34; no auditor attestation of internal control over financial reporting3
  • On EDGAR sinceSep 12, 20241
  • Filings231 in all: 4 (82), 144 (68), 3 (18), 8-K (13), 10-Q (5), SCHEDULE 13D (5), CORRESP (4), SCHEDULE 13D/A (4)1
    All 29 form types

    SCHEDULE 13G (3), SCHEDULE 13G/A (3), 10-K (2), ARS (2), DEF 14A (2), DEFA14A (2), S-8 (2), SEC STAFF LETTER (2), UPLOAD (2), 144/A (1), 424B4 (1), 8-A12B (1), CERT (1), DRS (1), DRS/A (1), DRSLTR (1), EFFECT (1), S-1 (1), S-1/A (1), S-1MEF (1), S-3ASR (1)

  • Latest filingsAnnual report (10-K) Mar 2, 2026
    Quarterly report (10-Q) Aug 6, 2026
    Proxy statement (DEF 14A) Apr 27, 2026
    Latest 8-K (8-K) Sep 14, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.001 par value per shareSIONThe Nasdaq Global Market

From the cover page of the 10-K filed Mar 2, 2026 (Section 12(b) of the Exchange Act).3

Risk factors and legal proceedings

The risks Sionna Therapeutics, Inc. names in Item 1A of its 10-K filed Mar 2, 2026: 72 risks under these headings, as written.3

  • Risks Related to Our Limited Operating History, Financial Condition and Need for Additional Capital
  • We are a clinical-stage biopharmaceutical company and have incurred significant operating losses since inception and anticipate that we will continue to incur significant operating losses for the foreseeable future. Our net losses were $75.3 million and $61.7 million for the years ended December 31, 2025 and 2024, respectively. We had an accumulated deficit of $256.4 million and $181.1 million as of December 31, 2025 and 2024, respectively. We may never achieve or maintain profitability.
  • We will need substantial additional funding to develop and, if approved, commercialize our product candidates and identify and invest in new product candidates. We may be unable to raise capital on acceptable terms, if at all, and, as a result, we may be required to delay, reduce or eliminate our product development programs or commercialization efforts.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our product candidates.
  • Risks Related to the Discovery and Development of Our Product Candidates
  • We are substantially dependent on the success of at least one of our nucleotide binding domain 1 ("NBD1") stabilizers. If we are unable to advance an NBD1 stabilizer product candidate into later-stage clinical development or unable to obtain regulatory approval and commercialize an NBD1 stabilizer-anchored combination therapy for the treatment of cystic fibrosis, or experience significant delays in doing so, our business will be materially harmed.
  • We are early in our development efforts. If we are unable to successfully develop, receive regulatory approval for and commercialize any product candidate, or experience significant delays in doing so, our business will be substantially harmed.
  • We intend to develop a proprietary dual combination of an NBD1 stabilizer with a complementary modulator and/or an NBD1 stabilizer as an add-on to the standard of care. Developing combination treatments increases complexity and risk, including risks of drug-drug interactions, unforeseen side effects or failures in our clinical trials that could delay or prevent their regulatory approval or limit the commercial profile of an approved label.
  • The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time-consuming and inherently unpredictable. If we are not able to obtain the required regulatory approval for any product candidate, our business will be substantially harmed.
  • Preclinical and clinical product development involves a lengthy and expensive process, with an uncertain outcome.
  • We may incur additional costs and experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
  • Targeting the NBD1 domain of the CFTR protein is novel, and the time, cost of development, and likelihood of successful product development is difficult to predict.
The other 61 risks
  • Our preclinical studies and clinical trials may fail to demonstrate the safety and efficacy of our product candidates, or serious or unacceptable adverse side effects or unexpected toxicology findings may be identified during the development of our product candidates, which could prevent or delay further clinical development, regulatory approvals and commercialization, impact the product’s labeling, if approved, increase our costs or necessitate the abandonment or limitation of the development of some of our product candidates.
  • We may not be able to obtain orphan drug designation or exclusivity for our product candidates, and even if we do, we may be unable to maintain the benefits associated with orphan drug designation, including the potential for market exclusivity.
  • While we may in the future seek designations for our product candidates with the FDA and comparable foreign regulatory authorities that are intended to confer benefits such as a faster development process, an accelerated regulatory pathway or priority review, there can be no assurance that we will successfully obtain such designations. In addition, even if one or more of our product candidates are granted such designations, we may not be able to realize the intended benefits of such designations.
  • We may not be able to submit investigational new drug applications "INDs" or IND amendments to commence clinical trials on the timelines we expect, and even if we are able to, the FDA may not permit us to proceed.
  • Any product candidate for which we obtain marketing approval could be subject to restrictions or withdrawal from the market, and we may be subject to substantial penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our product candidates, when and if any of them is approved.
  • If we experience delays or difficulties in the enrollment and/or retention of patients in clinical trials, our clinical development activities could be delayed or otherwise adversely affected, and our receipt of necessary regulatory approvals could be delayed or prevented.
  • The results of clinical trials conducted at clinical trial sites outside the U.S. might not be accepted by the FDA, and data developed outside of a foreign jurisdiction similarly might not be accepted by such foreign regulatory authority.
  • If any third-party manufacturer of our product candidates is unable to increase the scale of its production of our product candidates or increase the product yield of its manufacturing, then our manufacturing costs may increase and commercialization may be delayed.
  • Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.
  • Certain of our programs may compete with our other programs, which could negatively impact our business and reduce our future revenue.
  • Due to the significant resources required for the development of our pipeline, and depending on our ability to access capital, we must prioritize the development of certain product candidates over others. We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • Risks Related to Our Dependence on Third Parties
  • We are dependent on licensed intellectual property. If we were to lose our rights to licensed intellectual property, we may not be able to continue developing or commercializing our product candidates, if approved. If we breach any of the agreements under which we license the use, development and commercialization rights to our product candidates from third parties or, in certain cases, we fail to meet certain development deadlines, we could lose license rights that are important to our business.
  • We currently rely on, and in the future intend to rely on, third parties to conduct a significant portion of our clinical trials and potential future clinical trials for product candidates, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials.
  • We contract with third parties for the manufacture of our product candidates for clinical drug supply and expect to continue to do so for commercialization, if our product candidates are approved. This reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or obtain such quantities at an acceptable cost or quality, which could delay, prevent or impair our development or commercialization efforts.
  • We may seek to establish collaborations, license agreements and other similar arrangements with third parties for the development or commercialization of our product candidates. If we are not able to establish them on commercially reasonable terms, or if those arrangements are not successful, we may have to alter our development and commercialization plans.
  • Risks Related to Our Intellectual Property
  • If we or our licensors are unable to obtain, maintain and enforce intellectual property rights relating to any of our product candidates, or if the scope of the protection obtained is not sufficiently broad, our competitors or other third parties could develop and commercialize products similar or identical to ours, our ability to successfully commercialize our product candidates may be adversely affected and we may not be able to compete effectively in our markets.
  • Patent terms may be inadequate to protect our competitive position on our products, if approved, for an adequate amount of time, and if we do not obtain protection under the Hatch-Waxman Amendments and similar non-U.S. legislation for extending the term of patents covering each of our product candidates, our business may be materially harmed.
  • If we fail to comply with our obligations in any current intellectual property licenses with third parties, or fail to obtain such licenses in the future, we could lose rights that are material to our business.
  • Patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of any future patents we obtain.
  • We may be involved in lawsuits to protect or enforce our patents, which could be expensive, time consuming and unsuccessful.
  • Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain.
  • We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information or trade secrets of third parties.
  • We may be subject to claims challenging the inventorship or ownership of our intellectual property, including any patents we obtain.
  • Reliance on third parties requires us to share trade secrets, which increases the possibility that trade secrets will be misappropriated or disclosed, and confidentiality agreements with employees and third parties may not adequately prevent disclosure of trade secrets and protect other proprietary information.
  • We may enjoy only limited geographical protection with respect to certain patents and we may not be able to protect our intellectual property rights throughout the world.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • Any trademarks we have obtained or may obtain may be infringed or otherwise violated, or successfully challenged. If our trademarks and trade names are not adequately protected, or if we are unable to obtain desired trademarks or trade names, then we may not be able to build brand name recognition in our markets of interest and our business may be adversely affected.
  • Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
  • If we are unable to obtain licenses from third parties on commercially reasonable terms or fail to comply with our obligations under such agreements, our business could be harmed.
  • Risks Related to Legal and Regulatory Compliance Matters
  • Our business operations and our relationships with healthcare providers, third-party payors, patients and other parties in the healthcare industry are subject, directly or indirectly, to significant regulation under a broad range of healthcare laws, including fraud and abuse laws. Any action against us for violation of such laws could harm our reputation and require significant resources for defense. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.
  • Even if we obtain regulatory approvals for our product candidates or any future product candidates, they will remain subject to ongoing regulatory oversight.
  • Healthcare and other reform initiatives may have an adverse impact on our business and results of operations.
  • Risks Related to the Commercialization of Our Product Candidates
  • We face substantial competition. Our main competitor in the CF market holds substantial market share and has substantially greater resources than we do. We may not be able to compete successfully in this environment and, in particular, against a much larger competitor.
  • Even if any of our product candidates receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.
  • The success of our product candidates or any future product candidate will depend significantly on coverage and adequate reimbursement by third party payors or the willingness of patients to pay for these products if not covered.
  • The market for our product candidates may be smaller than we estimate.
  • Clinical trial and product liability lawsuits against us could divert our resources, cause us to incur substantial liabilities and limit commercialization of any products that we may develop.
  • Risks Related to Our Business Operations, Employee Matters and Managing Our Growth
  • Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.
  • We expect to expand our clinical development and regulatory capabilities and potentially implement sales, marketing and distribution capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
  • Our business could be affected by litigation, government investigations and enforcement actions.
  • Inadequate funding for the FDA, the Securities and Exchange Commission and other government agencies, including from government shut downs, or other disruptions to these agencies’ operations, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
  • Our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, suppliers and vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.
  • If our third-party manufacturers or suppliers do not comply with laws regulating the protection of the environment and health and human safety, our business could be affected adversely.
  • Our insurance policies are expensive and only protect us from some business risks, which will leave us exposed to significant uninsured liabilities.
  • We may engage in strategic transactions that could increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities, subject us to other risks, adversely affect our liquidity, increase our expenses, present significant distractions to our management and harm our financial condition and results of operations.
  • Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.
  • Risks Related to Ownership of Our Common Stock
  • Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations.
  • The trading price of the shares of our common stock may be volatile, and investors could lose all or part of their investment.
  • We may not be able to satisfy listing requirements of Nasdaq or obtain or maintain a listing of our common stock on Nasdaq.
  • Provisions in our corporate charter documents and under Delaware law may prevent or frustrate attempts by our stockholders to change our management and hinder efforts to acquire a controlling interest in us, and the market price of our common stock may be lower as a result.
  • Our executive officers, directors, principal stockholders, and their respective affiliates own a significant percentage of our stock and are able to exert significant control over matters subject to stockholder approval.
  • We do not anticipate paying any cash dividends on our common stock in the foreseeable future.
  • Our bylaws designate certain courts as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
  • General Risk Factors
  • If our information technology systems or data, or those of third parties upon which we rely, are or were compromised, or fail, we could experience adverse consequences resulting from such compromise, or failure, including but not limited to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; and other adverse consequences.
  • We are subject to stringent and evolving U.S. laws and regulations and foreign laws, regulations, rules, contractual obligations, policies and other obligations related to data privacy and security. Our actual or perceived failure to comply with such obligations could lead to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations, reputational harm, loss of revenue or profits, and other adverse business consequences.
  • Artificial intelligence presents risks and challenges that can impact our business, including by posing cybersecurity risks to our confidential information, proprietary information, and personal data.
  • We are subject to governmental export and import controls, economic sanctions, anti-corruption laws and regulations of the U.S. and other jurisdictions. We can face criminal liability and other serious consequences for violations of these laws and regulations, which could harm our business.
  • If we fail to maintain an effective system of internal controls over financial reporting, our ability to produce accurate financial statements on a timely basis could be impaired.
  • Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
  • We might not be able to utilize a significant portion of our net operating loss carryforwards.
  • New tax laws or regulations, changes to existing tax laws or regulations or changes in their application to us may have a material adverse effect on our business, cash flows, financial condition or results of operations.

Legal proceedings

From time to time, we may become involved in legal proceedings arising from the ordinary course of business. We record a liability for such matters when it is probable that future losses will be incurred and that

such losses can be reasonably estimated. Significant judgment by us is required to determine both probability and the estimated amount. Our management is currently not aware of any legal matters that could have a material effect on our financial position, results of operations or cash flows, nor are we aware of any governmental proceedings involving potential monetary sanctions of $300,000 or more.

The opening of Item 3, Legal Proceedings.3

Sources

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