Sign in

PVLA on Nasdaq

PALVELLA THERAPEUTICS, INC.

PALVELLA THERAPEUTICS, INC. is an American pharmaceutical preparations company, incorporated in Nevada.1 It is headquartered in Wayne, Pennsylvania.1 Its shares trade on Nasdaq under the symbol PVLA.1

Price unavailable

Last updated Oct 21, 2026.

Overview

Compare with Wave Life Sciences, Verona Pharma or Xilio Therapeutics, Inc., or pick any stock.

  • TickerPVLA on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersWayne, Pennsylvania1
  • Incorporated inNV2
  • Business address353 W. Lancaster Avenue, Suite 200, Wayne, Pa 190872
  • Filer categoryNon-accelerated filer, Smaller reporting company2

See how the biggest companies compare on our leaderboards

Financials

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

Key numbers, fiscal 2023

-27.7%Operating margin4
43.7%Net margin4
65.3%Revenue growth, 20235
-$13.9MFree cash flow4

Where the money goes

Where each dollar of revenue went, fiscal 2023

  • Research and development21¢$8.8M
  • Other costs36¢$15.3M
  • Profit44¢$18.7M

Out of $42.8M in revenue.54

Financial statements

Revenue6785$42.8M in 2023−2% since 2019
0$20.0M$40.0M$60.0M2019: $43.6M$43.6M20192020: $29.3M$29.3M2020−33%2021: $31.4M$31.4M2021+7%2022: $25.9M$25.9M2022−18%2023: $42.8M$42.8M2023+65%
Operating income97854-$11.9M in 2023−56% since 2019
-$60.0M-$40.0M-$20.0M02019: -$27.2M-$27.2M20192020: -$33.9M-$33.9M2020+25%2021: -$51.8M-$51.8M2021+53%2022: -$43.5M-$43.5M2022−16%2023: -$11.9M-$11.9M2023−73%
Net income97854$18.7M in 2023
-$60.0M-$40.0M-$20.0M0$20.0M2019: -$25.5M-$25.5M20192020: -$37.2M-$37.2M2020+46%2021: -$45.7M-$45.7M2021+23%2022: -$33.3M-$33.3M2022−27%2023: $18.7M$18.7M2023

Every line of the income statement as filed: the last 2 fiscal years, latest first.12

Period ending2025-12-312024-12-31
Research and development$22.8M$8.2M
General and administrative$15.8M$5.9M
Total operating expenses$38.6M$14.1M
Operating loss-$38.6M-$14.1M
Interest expense - royalty agreement-$5.8M-$3.9M
Interest expense - convertible notes payable$0-$430.0K
Fair value adjustments on derivative liabilities - royalty agreement-$394.0K-$633.0K
Fair value adjustments on convertible notes payable$0$1.1M
Fair value adjustments on derivative liabilities - contingent value right liability-$218.0K-$2.0M
Other income - German R&D tax credit receivable$0$2.0M
Interest income, net$2.6M$642.0K
Other income (expense), net$727.0K-$131.0K
Loss before income taxes-$41.7M-$17.4M
Income tax benefit (expense)$0$0
Net loss-$41.7M-$17.4M
Foreign currency translation gain$80.0K$3.0K
Comprehensive loss-$41.6M-$17.4M
Net loss per share of Common Stock - basic (in dollars per share)-$3.71-$7.83
Net loss per share of Common Stock - diluted (in dollars per share)-$3.71-$7.83
Weighted-average shares used in computing net loss per share of Common Stock - basic (in shares)11.3M shares2.2M shares
Weighted-average shares used in computing net loss per share of Common Stock - diluted (in shares)11.3M shares2.2M shares

Compare PALVELLA THERAPEUTICS, INC. with another company

Corporate structure

PALVELLA THERAPEUTICS, INC. sits at the top of its group. 2 entities, 2 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of PALVELLA THERAPEUTICS, INC.

  • PALVELLA THERAPEUTICS, INC. Wayne, Pennsylvania
    • Pieris Pharmaceuticals GmbH Subsidiary · Germany

Built from subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What PALVELLA 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
Operating-lease assets (leased space)$572.0K12 Dec 31, 2025$012 Dec 31, 2024

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$58.0M12 Dec 31, 2025$83.6M12 Dec 31, 2024−30.6%

Properties, in its own words

Our principal executive office is located in Wayne, Pennsylvania, where we lease 6,853 square feet of space that we use for our administrative, research and development and other activities. We believe that our existing facilities are

adequate for our near-term needs but expect to need additional space as we grow. We believe that suitable additional or alternative space would be available as required in the future on commercially reasonable terms.

Item 2 of the 10-K filed Mar 31, 2026.13

Leadership

Who has led PALVELLA THERAPEUTICS, INC., and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Stephen S. Yoder2015–2023
  2. Wes Kaupinen2024–now

President

  1. Stephen S. Yoder2015–2016
  2. Wes Kaupinen2024–now

Chief financial officer

  1. Darlene M. Deptula-Hicks2015–2016
  2. Lance E. Thibault2017
  3. Allan Reine2018–2019
  4. Thomas Bures2022–2023
  5. Matthew E. Korenberg2024–now

Chief operating officer

  1. Kathleen Goin2024–now
20202025
Board members and other officers (30)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Palvella Therapeutics, Inc. Delaware3
  • Pieris Pharmaceuticals GmbH Germany3

The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Former names

  • PIERIS PHARMACEUTICALS, INC.Dec 23, 2014 to Dec 12, 20242
  • Marika Inc.Aug 20, 2013 to Dec 18, 20142

Timeline

  1. Aug 4, 20268-K Results of operations; Regulation FD disclosure50
  2. Jul 14, 20268-K Other events51
  3. Jun 30, 20268-K Executive or director change52
  4. Jun 16, 20268-K Executive or director change; Shareholder vote53
  5. May 20, 20268-K Other events54
  6. May 15, 20268-K Other events55
  7. May 13, 20268-K Other events56
  8. May 7, 20268-K Results of operations; Regulation FD disclosure57
  9. Apr 13, 20268-K Executive or director change58
  10. Apr 7, 20268-K Other events59
  11. Mar 31, 20268-K Results of operations; Regulation FD disclosure60
  12. Feb 26, 20268-K Entered a material agreement61
  13. Dec 16, 2024New chief executive Wes Kaupinen becomes CEO14
  14. Jun 29, 2015New chief executive Stephen S. Yoder becomes CEO15

Calendar

Coming up

  1. Nov 10, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($1.03) a share, on Nov 11, 2025.62

When it reported results

  1. Aug 4, 2026Reported quarterly or annual results50
  2. May 7, 2026Reported quarterly or annual results57
  3. Mar 31, 2026Reported quarterly or annual results60
  4. Feb 24, 2026Reported quarterly or annual results63
  5. Nov 10, 2025Reported quarterly or annual results64
  6. Aug 14, 2025Reported quarterly or annual results65
  7. May 15, 2025Reported quarterly or annual results66
  8. Mar 31, 2025Reported quarterly or annual results67

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

Filings

316 filings to the SEC since October 2021: 7 annual reports, 15 quarterly reports, 68 major events, 105 insider forms, 45 large holders, 76 other. The latest 20:

  1. Oct 14, 20264 OWNERSHIP DOCUMENT EDGAR
  2. Oct 13, 2026144 EDGAR
  3. Sep 18, 20264 OWNERSHIP DOCUMENT EDGAR
  4. Sep 16, 2026144 EDGAR
  5. Sep 15, 20264 OWNERSHIP DOCUMENT EDGAR
  6. Sep 11, 2026144 EDGAR
  7. Sep 4, 20264 OWNERSHIP DOCUMENT EDGAR
  8. Sep 2, 2026144 EDGAR
  9. Aug 20, 20264 OWNERSHIP DOCUMENT EDGAR
  10. Aug 19, 2026144 EDGAR
  11. Aug 14, 2026SCHEDULE 13G/A EDGAR
  12. Aug 14, 2026SCHEDULE 13G/A EDGAR
  13. Aug 10, 2026SCHEDULE 13G EDGAR
  14. Aug 4, 202610-Q EDGAR
  15. Aug 4, 20268-K EDGAR
  16. Aug 4, 2026S-8 EDGAR
  17. Aug 3, 2026SCHEDULE 13G EDGAR
  18. Jul 29, 2026SCHEDULE 13G EDGAR
  19. Jul 17, 20264 OWNERSHIP DOCUMENT EDGAR
  20. Jul 15, 2026144 EDGAR

The 316 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

25 open-market trades by officers, directors and large owners since October 2021: 10 buys and 15 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 16, 2026Goin KathleenChief Operating OfficerSale4,302$152.24$654.9KForm 4
Sep 15, 2026JENKINS GEORGE MDirectorSale1,777$150.15$266.8KForm 4
Sep 14, 2026JENKINS GEORGE MDirectorSale13,352$151.96$2.0MForm 4
Sep 11, 2026JENKINS GEORGE MDirectorSale12,371$151.28$1.9MForm 4
Sep 2, 2026KIRITSY CHRISTOPHER PDirectorSale313$157.00$49.1KForm 4
Aug 19, 2026Goin KathleenChief Operating OfficerSale4,302$152.21$654.8KForm 4
Jul 15, 2026Goin KathleenChief Operating OfficerSale4,302$149.28$642.2KForm 4
Jun 17, 2026Goin KathleenChief Operating OfficerSale4,302$110.73$476.4KForm 4
May 20, 2026Goin KathleenChief Operating OfficerSale4,302$110.56$475.6KForm 4
Apr 15, 2026Goin KathleenChief Operating OfficerSale4,302$127.24$547.4KForm 4
Mar 30, 2026JENKINS GEORGE MDirectorBuy445$112.30$50.0KForm 4
Mar 18, 2026Goin KathleenChief Operating OfficerSale4,302$117.99$507.6KForm 4
Feb 27, 2026JENKINS GEORGE MDirectorBuy4,000$125.00$500.0KForm 4
Feb 27, 2026HERON ELAINE JDirectorBuy2,400$125.00$300.0KForm 4
Feb 18, 2026Goin KathleenChief Operating OfficerSale4,302$79.40$341.6KForm 4
Jan 21, 2026Goin KathleenChief Operating OfficerSale4,302$97.63$420.0KForm 4
Dec 17, 2025Goin KathleenChief Operating OfficerSale4,302$96.47$415.0KForm 4
Nov 19, 2025Goin KathleenChief Operating OfficerSale4,302$86.23$371.0KForm 4
Apr 9, 2025JENKINS GEORGE MDirectorBuy4,990$20.20$100.8KForm 4
Dec 18, 2024JENKINS GEORGE MDirectorBuy4,000$12.93$51.7KForm 4

All 25 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
2025Wesley H. KaupinenPresident and Chief Executive Officer48$575.0K$3.4M87
2025Kathleen GoinChief Operating Officer56$481.3K$2.0M87
2025Matthew E. KorenbergChief Financial Officer 51$475.3K$2.0M87
2024Wesley H. KaupinenPresident and Chief Executive Officer48$384.9K$5.4M87
2024Kathleen GoinChief Operating Officer56$381.4K$1.1M87

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
Montanova Capital, LLC1,135,406$173.5M3.6%−18,090
Jennison Associates LLC960,619$146.8M0.1%+320,008
BlackRock, Inc.918,357$140.3M0.0%+231,504
Frazier Life Sciences Management, L.P.882,400$134.8M2.9%No change
First Light Asset Management, LLC771,901$118.0M7.2%−208,857
Bvf Inc/il672,789$102.8M2.6%−288,200
State Street Corp653,172$99.8M0.0%+194,173
Vanguard Capital Management LLC513,794$78.5M0.0%+36,500
Frontier Capital Management Co LLC478,833$73.2M0.7%+104,798
Federated Hermes, Inc.433,015$66.2M0.1%No change
Woodline Partners LP317,517$48.5M0.2%No change
Orbimed Advisors LLC292,360$44.7M0.8%+157,760
Geode Capital Management, LLC276,164$42.2M0.0%+70,555
Siren, L.L.C.257,485$39.3M0.8%No change
Primecap Management Co/ca/256,182$39.1M0.0%+61,152
Eventide Asset Management, LLC231,484$35.4M0.5%−1,764
Emerald Advisers, LLC229,486$35.1M0.8%+67,986
Fmr LLC214,841$32.8M0.0%−967
Alliancebernstein L.P.253,168$31.6M0.0%−9,667
Mpm Bioimpact LLC204,027$31.2M1.9%−2,377
Goldman Sachs Group Inc201,514$30.8M0.0%+7,335
Morgan Stanley181,428$27.7M0.0%+53,441
First Turn Management, LLC156,450$23.9M2.6%+8,357
Bellevue Group AG155,000$23.7M0.5%New
Emerald Mutual Fund Advisers Trust129,847$19.8M0.7%+24,027

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

SEC filer profile

How PALVELLA 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 EDGARPALVELLA THERAPEUTICS, INC.1
  • CIK0001583648
  • Employer ID (EIN)30-078434613
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company13
  • Incorporated inNevada13
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address353 W. Lancaster Avenue, Suite 200, Wayne, PA 190871
  • Phone(484) 253-14611
  • Shares outstanding14,408,407 as of Jul 31, 202611
  • Public float$196.7M as of Jun 30, 202513
  • AuditorErnst & Young LLP, Philadelphia, Pennsylvania PCAOB ID 42; no auditor attestation of internal control over financial reporting13
  • On EDGAR sinceAug 20, 20131
  • Filings810 in all: 8-K (212), 4 (202), 3 (41), 10-Q (38), SC 13G/A (34), CORRESP (20), SC 13G (20), 424B3 (19)1
    All 42 form types

    CT ORDER (19), UPLOAD (16), 144 (14), S-8 (14), 10-K (13), EFFECT (13), DEF 14A (12), SCHEDULE 13G/A (11), DEFA14A (10), SC 13D/A (10), 424B5 (8), 425 (8), S-1/A (8), SCHEDULE 13G (8), S-3 (7), 10-K/A (6), 4/A (6), 10-Q/A (5), S-4/A (5), ARS (4), D (4), S-1 (4), 8-K/A (3), POS AM (3), S-3/A (2), SC 13D (2), SEC STAFF LETTER (2), 144/A (1), 3/A (1), 424B4 (1), 8-A12B (1), CERTNAS (1), S-4 (1), SCHEDULE 13D (1)

  • Latest filingsAnnual report (10-K) Mar 31, 2026
    Quarterly report (10-Q) Aug 4, 2026
    Proxy statement (DEF 14A) Apr 30, 2026
    Latest 8-K (8-K) Aug 4, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.001 per sharePVLANasdaq

From the cover page of the 10-K filed Mar 31, 2026 (Section 12(b) of the Exchange Act).13

Risk factors and legal proceedings

The risks PALVELLA THERAPEUTICS, INC. names in Item 1A of its 10-K filed Mar 31, 2026: 75 risks under these headings, as written.13

  • Risks Related to Our Limited Operating History, Financial Position and Capital Requirements
  • We have historically incurred significant operating losses and anticipate that we will continue to incur significant operating losses for at least the next several years. We may never achieve or maintain profitability.
  • We have never generated revenue from product sales and may never achieve or maintain profitability.
  • Our limited operating history may make it difficult to evaluate our business to date and our future viability.
  • We will likely require substantial additional funding to finance our operations, which may cause dilution to our stockholders. Failure to obtain this necessary funding when needed on acceptable terms, or at all, could force it to delay, limit, reduce or terminate our product development, commercialization efforts or other operations.
  • Our development funding agreement with Ligand obligates us to make certain milestone payments, some of which will be triggered prior to our commercialization of any of our product candidates.
  • Our ability to utilize our net operating loss (“NOL”) carryforwards and certain other tax attributes may be limited.
  • Risks Related to the Discovery, Development, Regulatory Approval and Commercialization of Our Product Candidates
  • Clinical drug development is a lengthy, complex and expensive process, with an uncertain outcome. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development of our product candidates.
  • Our future success is substantially dependent on the successful clinical development, regulatory approval and commercialization of QTORIN rapamycin, which is in later stages of development than our other product candidates.
  • We plan to submit an NDA to the FDA for the marketing approval of QTORIN rapamycin for microcystic LMs, based largely on data from our completed Phase 3 SELVA study; however, there can be no assurance that the data from our clinical trials will ultimately support filing of an NDA by the FDA or that the FDA will grant marketing approval of QTORIN rapamycin for microcystic LMs without additional clinical or nonclinical studies, or at all.
  • We may be unable to obtain regulatory approval for our product candidates under applicable regulatory requirements. The denial or delay of any such approval would adversely impact our potential to generate revenue, our business and our results of operations.
The other 63 risks
  • Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials.
  • The rare skin diseases and vascular malformations we are currently targeting have no FDA-approved therapies, which subjects the design and execution of our clinical development programs to complexities and known as well as unknown risks, including those related to novel and/or subjective clinical endpoints and varying patient population characteristics.
  • Our lead product candidates are based on our QTORIN platform, which is highly dependent on the successful development of this novel and unproven technology.
  • We may find it difficult to enroll subjects in our clinical trials, which could delay or prevent us from proceeding with clinical trials of our product candidates.
  • Orphan Drug Designation has been granted for QTORIN rapamycin for the treatment of LM, but we may be unable to obtain such designation for other diseases or conditions or product candidates or to realize the benefits of Orphan Drug Designation, including potential marketing exclusivity, even if such designation is obtained.
  • We are targeting serious, rare skin diseases and vascular malformations, and the small patient populations associated with such diseases and malformations present additional risks with respect to clinical development, regulatory approvals and commercialization of product candidates.
  • Our development and commercialization strategy for our product candidates depends, in part, on published scientific literature and the FDA’s prior findings regarding the safety and efficacy of rapamycin, pitavastatin and other planned or future product candidates. If we are not able to pursue this strategy, we may be delayed in receiving regulatory authority approval.
  • The validity, scope and enforceability of any patents that we may list in the Orange Book that cover QTORIN rapamycin or QTORIN pitavastatin, if approved by the FDA for any indication, can be challenged by competitors.
  • Other companies could receive FDA approval for a topical rapamycin or pitavastatin product before we receive FDA approval for our product candidates for microcystic LMs, cutaneous VMs, clinically significant angiokeratomas or DSAP and thus could be granted regulatory exclusivity that could significantly delay our ability to receive approval for and commercialize our product candidates and therefore dramatically reduce our market potential.
  • Serious adverse or unacceptable side effects may be identified during the development of our product candidates, which could prevent or delay regulatory approval and commercialization, increase our costs or necessitate the abandonment or limitation of the development of some of our product candidates.
  • Fast Track Designation has been granted for QTORIN rapamycin for the treatment of microcystic LM, the treatment of cutaneous VMs and the treatment of angiokeratomas, but we may never be able to realize the benefits of such designation for QTORIN rapamycin or any other indications or future product candidates, if granted, and such designation may not lead to a faster development, regulatory review, approval process or increase the likelihood that our product candidates will receive marketing approval.
  • Breakthrough Therapy Designation has been granted for QTORIN rapamycin for the treatment of microcystic LM but we may never be able to realize the benefits of such designation for QTORIN rapamycin or any other indications
  • or future product candidates, if granted, and such designation may not lead to a faster development, regulatory review or approval process or increase the likelihood that our product candidates will receive marketing approval.
  • Interim, topline or preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • 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.
  • We may choose not to continue developing or commercializing any of our product candidates at any time during development or after approval, if granted, which would reduce or eliminate our potential return on investment for those product candidates.
  • If we seek to market any product candidates in our pipeline in countries other than the United States, we will need to comply with the regulations of each country in which we seek to market our products. Additionally, although our trials are currently being conducted in the U.S., we may conduct clinical trials for our product candidates at clinical trial sites outside the U.S. and the FDA and equivalent non-U.S. regulatory authorities may not accept data from such sites.
  • Governments outside of the United States tend to impose strict price controls, which may adversely affect our revenue, if any.
  • Risks Related to Commercialization of Our Product Candidates, if Approved
  • Even if QTORIN rapamycin, QTORIN pitavastatin or any future product candidates receive marketing approval, they may fail to achieve market acceptance by physicians, patients, third-party payors or others in the medical community necessary for commercial success.
  • We currently have no sales organization and have no experience as a company in commercializing products, and we may have to invest significant resources to develop these capabilities. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our product candidates, if approved, we may not be able to generate product revenue.
  • Our estimated market opportunities for our product candidates are subject to numerous uncertainties and may prove to be inaccurate. If we have overestimated the size of our market opportunities, our future growth may be limited.
  • The size of the markets for our product candidates has not been established and may be smaller than we estimate.
  • If we are unable to achieve and maintain coverage and adequate levels of reimbursement for any of our product candidates for which we receive regulatory approval, or any future products we may seek to commercialize, our commercial success may be severely hindered.
  • We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do, thus rendering our products non-competitive, obsolete or reducing the size of our market.
  • If we obtain approval to commercialize our product candidates outside of the United States, a variety of risks associated with international operations could materially adversely affect our business.
  • Risks Related to Our Business and Operations
  • We will need to increase the size of our organization, and we may experience difficulties in executing our growth strategy and managing any growth, including with respect to any acquired businesses, therapeutic candidates or technologies.
  • If we fail to attract and retain management and other key personnel, we may be unable to continue to successfully develop our current and any future product candidates, commercialize our product candidates or otherwise implement our business plan.
  • We face potential product liability exposure, and if successful claims are brought against us, we may incur substantial liability for our product candidates and may have to limit our commercialization if we obtain regulatory approval.
  • Unfavorable global economic or political conditions could adversely affect our business, financial condition or results of operations.
  • We are subject to stringent and changing laws, regulations and standards, and contractual obligations relating to privacy, data protection, and data security. Our business and operations would suffer in the event of cybersecurity incidents, data breaches, or system failures, and we face risks related to our collection and use of data, which could result in investigations, inquiries, litigation, fines, legislative and regulatory action and negative press about our privacy and data protection practices.
  • Our use of new and evolving technologies, such as artificial intelligence, may present risks and challenges that can impact our business, including by posing cybersecurity and other risks to our confidential and/or proprietary information, including personal information, and as a result we may be exposed to reputational harm and liability.
  • If we or our third-party contractors fail to comply with environmental, health and safety laws and regulations, it could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.
  • Risks Related to Healthcare Laws and Other Legal Compliance Matters
  • Even if we receive regulatory and marketing approval of our product candidates, we will be subject to extensive and ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense, and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates.
  • Our product candidates, if approved for marketing, may cause or contribute to adverse medical events that we are required to report to the FDA, and if we fail to do so, we would be subject to sanctions that could harm our reputation, business, financial condition and results of operations. The discovery of serious safety issues with our product candidates, or a recall of our products either voluntarily or at the direction of the FDA or another governmental authority, if such products are marketed, could have a negative impact on us.
  • We will be subject to healthcare laws and regulations relating to our business and could face substantial penalties if we are determined not to have fully complied with such laws, which would have an adverse impact on our business.
  • Healthcare reform measures may increase the difficulty and cost for us to successfully commercialize our product and product candidates, if approved, and affect the prices we may obtain.
  • Any product candidates for which we are able to obtain regulatory approval in the future may become subject to unfavorable pricing regulations, third-party payor coverage and reimbursement policies, or healthcare reform initiatives.
  • If any of our product candidates are approved for marketing and we are found to have improperly promoted off-label uses, we may become subject to prohibitions on the sale or marketing of our products, product liability claims and significant fines, penalties and sanctions, and our brand and reputation could be harmed.
  • Our business activities may be subject to the FCPA and similar anti-bribery and anti-corruption laws of other countries in which we operate, as well as U.S. and certain foreign export controls, trade sanctions, and import laws
  • and regulations. Compliance with these legal requirements could limit our ability to compete outside of the U.S. market and subject us to liability if we violate them.
  • Risks Related to Our Reliance on Third Parties
  • We currently rely on CMOs to manufacture preclinical and clinical supplies of our product candidates and expect to rely on CMOs for the commercial supplies of any approved product candidates. The loss of these manufacturers, or their failure to provide us with sufficient quantities at acceptable quality levels or prices, or at all, would materially and adversely affect our business.
  • If the manufacturers upon whom we rely fail to produce our product candidates or components pursuant to the terms of contractual arrangements with us or fail to comply with stringent regulations applicable to pharmaceutical manufacturers, we may face delays in the development and commercialization of, or be unable to meet demand for, our product candidates, if approved, and may lose potential revenues.
  • Certain of our supplies, including the pumps we intend to use to dispense our QTORIN rapamycin and QTORIN pitavastatin, if approved, are obtained from a sole source supplier. If we experience an interruption in supply from these suppliers, our business may be harmed.
  • We rely on third parties to conduct aspects of our nonclinical studies and our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may be unable to obtain regulatory approval for or commercialize QTORIN rapamycin for the treatment of microcystic LM or any other current or future product candidates.
  • We may rely on third parties to perform many essential services for any products that we commercialize. If these third parties fail to perform as expected or to comply with legal and regulatory requirements, our ability to commercialize our product candidates will be significantly impacted and we may be subject to regulatory sanctions.
  • Our future commercial collaborators, as well as our independent contractors, including principal investigators, consultants, suppliers, service providers and other vendors, may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have an adverse effect on our results of operations.
  • We intend to explore strategic collaborations with third parties for the development or commercialization of our product candidates, which collaborations may never materialize or may require that we relinquish rights to and control over the development and commercialization of our product candidates.
  • Risks Related to Intellectual Property
  • We may not be able to obtain, maintain or enforce patent rights that cover our product candidates and technologies that are of sufficient breadth to prevent third parties from competing against us.
  • Patent terms may be inadequate to protect our competitive position and if we do not obtain additional patent protection by issuing additional patents with longer patent terms for our product candidates, our business may be materially harmed.
  • We may not be able to protect our intellectual property rights throughout the world.
  • Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for noncompliance with these requirements.
  • Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.
  • If we are unable to protect the confidentiality of our proprietary information and know-how, the value of our technology and products could be adversely affected.
  • We may be subject to claims challenging the inventorship or ownership of the patents and other intellectual property that we own or license.
  • We may become subject to claims alleging infringement of third parties’ patents or proprietary rights and/or claims seeking to invalidate our patents, which would be costly, time consuming and, if successfully asserted against us, delay or prevent the development and commercialization of our current product candidates or any future product candidates.
  • We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect our ability to develop and market our product candidates.
  • We may be subject to claims by third parties asserting that we, our employees or our licensors have misappropriated their intellectual property, including trade secrets, or claiming ownership of what we regard as our own intellectual property.
  • We may become involved in lawsuits to protect or enforce our patents or other intellectual property or the patents of our licensors, which could be expensive and time-consuming.
  • Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities, and have a harmful effect on the success of our business.
  • We may need to license additional intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms.
  • Our intellectual property agreements with third parties may be subject to disagreements over contract interpretation, which could narrow the scope of our rights to the relevant intellectual property or technology or increase our financial or other obligations to our licensors.
  • If we fail to comply with our obligations under any license, collaboration or other agreements, we may be required to pay damages and could lose intellectual property rights that are necessary or useful for developing and protecting our product candidates.

Legal proceedings

From time to time, we may become involved in legal proceedings or be subject to claims arising in the ordinary course of our business. We are not currently subject to any material legal proceedings.

The opening of Item 3, Legal Proceedings.13

Sources

The numbers on this page point here. Each one links to the record it came from.

  1. 1
  2. 2
  3. 3
  4. 4
  5. 5
  6. 6
  7. 7
  8. 8
  9. 9
  10. 10
  11. 11
  12. 12
  13. 13
  14. 14
  15. 15
  16. 16
  17. 17
  18. 18
  19. 19
  20. 20
  21. 21
  22. 22
  23. 23
  24. 24
  25. 25
  26. 26
  27. 27
  28. 28
  29. 29
  30. 30
  31. 31
  32. 32
  33. 33
  34. 34
  35. 35
  36. 36
  37. 37
  38. 38
  39. 39
  40. 40
  41. 41
  42. 42
  43. 43
  44. 44
  45. 45
  46. 46
  47. 47
  48. 48
  49. 49
  50. 50
  51. 51
    SEC EDGAROther events
  52. 52
  53. 53
  54. 54
    SEC EDGAROther events
  55. 55
    SEC EDGAROther events
  56. 56
    SEC EDGAROther events
  57. 57
  58. 58
  59. 59
    SEC EDGAROther events
  60. 60
  61. 61
  62. 62
  63. 63
  64. 64
  65. 65
  66. 66
  67. 67
  68. 68
  69. 69
  70. 70
  71. 71
  72. 72
  73. 73
  74. 74
  75. 75
  76. 76
  77. 77
  78. 78
  79. 79
  80. 80
  81. 81
  82. 82
  83. 83
  84. 84
  85. 85
  86. 86
  87. 87