Private company

Proteostasis Therapeutics (United States)

Proteostasis Therapeutics (United States) is an American pharmaceutical preparations company based in Cambridge.1 It was founded in 2006.1

Last updated Oct 20, 2026.

Overview

2006Founded1
  • IndustryPharmaceutical Preparations1
  • HeadquartersCambridge1
  • Websitewww.proteostasis.com
  • Incorporated inDE3
  • Business address7683 Se 27Th Street, Suite 481, Mercer Island, Wa 980403
  • Filer categoryNon-accelerated filer, Smaller reporting company3
  • Legal formCorporation

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Proteostasis Therapeutics (United States)
Photo: Jsslee, CC BY-SA 3.0, via Wikimedia Commons5

Financials

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

Key numbers, fiscal 2024

-100.0%Revenue growth, 20246

Financial statements

Revenue7896$0 in 2024
0$2.5M$5.0M$7.5M$10.0M2018: $2.8M$2.8M20182019: $5.0M$5.0M2019+76%2020: $6.9M$6.9M2020+38%2021: $8.0M$8.0M2021+17%2022: $2.0M$2.0M2022−76%2023: $5.4M$5.4M2023+179%2024: $0$02024
Operating income71081196-$13.5M in 2024−79% since 2018
-$80.0M-$60.0M-$40.0M-$20.0M02018: -$63.2M-$63.2M20182019: -$30.0M-$30.0M2019−52%2020: -$55.6M-$55.6M2020+85%2021: -$11.1M-$11.1M2021−80%2022: -$41.5M-$41.5M2022+274%2023: -$15.7M-$15.7M2023−62%2024: -$13.5M-$13.5M2024−14%
Net income71081112-$17.1M in 2024−72% since 2018
-$80.0M-$60.0M-$40.0M-$20.0M02018: -$61.8M-$61.8M20182019: -$31.2M-$31.2M2019−50%2020: -$57.5M-$57.5M2020+84%2021: -$11.8M-$11.8M2021−79%2022: -$63.4M-$63.4M2022+437%2023: -$14.1M-$14.1M2023−78%2024: -$17.1M-$17.1M2024+21%
Fiscal year2018201920202021202220232024
Revenue$2.8M7$5.0M7$6.9M8$8.0M8$2.0M9$5.4M6$06
Research and development$50.3M7$23.0M10$22.3M8$15.6M11$15.9M9$9.0M6$5.4M6
Operating expenses$20.2M11$43.5M9$21.2M6$13.5M6
Operating income-$63.2M7-$30.0M10-$55.6M8-$11.1M11-$41.5M9-$15.7M6-$13.5M6
Interest$1.2M10$1.9M8$1.3M11$3.7M9$337.0K9
Income tax$07$010$010$011$09$06$06
Net income-$61.8M7-$31.2M10-$57.5M8-$11.8M11-$63.4M12-$14.1M12-$17.1M12
Earnings per share-$2.7111-$12.879-$1.286-$1.426
Earnings per share (diluted)-$2.7111-$12.879-$1.286-$1.426
Shares (weighted, basic)4.4M shares114.9M shares911.1M shares612.1M shares6
Shares (weighted, diluted)4.4M shares114.9M shares911.1M shares612.1M shares6

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Corporate structure

Proteostasis Therapeutics (United States) sits at the top of its group. 4 entities, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Proteostasis Therapeutics (United States)

  • ARMISTICE CAPITAL, LLC Filed SCHEDULE 13G/A on Proteostasis Therapeutics (United States), latest Nov 14, 2025 (5 filings since Feb 14, 2024)
  • Raymond J. Bartoszek Filed SC 13D/A on Proteostasis Therapeutics (United States), latest May 2, 2024 (2 filings since Feb 14, 2023)
  • Charles Magness Filed SC 13G/A on Proteostasis Therapeutics (United States), latest Feb 12, 2024 (2 filings since Feb 14, 2023)
  • Shawn Iadonato Filed SC 13D/A on Proteostasis Therapeutics (United States), latest Feb 12, 2024 (2 filings since Feb 14, 2023)
  • CBI USA, Inc. Filed SC 13G on Proteostasis Therapeutics (United States), latest Feb 14, 2023
  • FMR LLC Filed SC 13G/A on Proteostasis Therapeutics (United States), latest Feb 10, 2023 (5 filings since Nov 10, 2021)
  • Redmile Group, LLC Filed SC 13G/A on Proteostasis Therapeutics (United States), latest Feb 14, 2022
  • Stonepine Capital Management, LLC Filed SC 13G/A on Proteostasis Therapeutics (United States), latest Feb 14, 2022 (2 filings since Nov 19, 2021)
  • Proteostasis Therapeutics (United States) Cambridge
    • Kineta Chronic Pain, LLC Subsidiary · Washington, United States
    • Kineta Operating, LLC Subsidiary · Delaware, United States
    • Yumanity, Inc. Subsidiary · Delaware, United States

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 Proteostasis Therapeutics (United States) 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$09 Dec 31, 2023$866.0K9 Dec 31, 2022−100.0%
Accumulated depreciation$09 Dec 31, 2023$617.0K9 Dec 31, 2022−100.0%
Property and equipment, net$06 Dec 31, 2024$06 Dec 31, 2023
Operating-lease assets (leased space)$06 Dec 31, 2024$472.0K6 Dec 31, 2023−100.0%

Properties, in its own words

Kineta leased office and laboratory premises in Seattle, Washington pursuant to a lease agreement that commenced in April 2011 and expired on July 31, 2024. This lease was not extended and no other facility lease was entered into as the Company's employees work remotely. Kineta believes that its current remote operating plan is adequate for its current needs and that suitable additional or substitute space at commercially reasonable terms will be available as needed to accommodate any future expansion of Kineta’s operations.

Item 2 of the 10-K filed Mar 6, 2025.16

Leadership

Who has led Proteostasis Therapeutics (United States), and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Meenu Chhabra2016–2020
  2. Shawn Iadonato2022–2023

President

  1. Meenu Chhabra2016–2020
  2. Craig Philips2022–now

Chief financial officer

  1. Helen M. Boudreau2017–2018
  2. Keith Baker2022–now

Chief operating officer

  1. Marija Zecevic2018–2019
  2. Sheila Wilson2019–2020
2010201520202025
Board members and other officers (41)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive Officer, DirectorShawn ladonato named Mar 1, 2022 to Jun 15, 202263
  • DirectorRichard R. Peters named Dec 29, 2022 to Oct 20, 202364
  • DirectorDon R. Merlino named Mar 1, 2022 to Jun 15, 202263
  • DirectorJiyoung R. Hwang named Jun 15, 202263
  • DirectorRichard R. Samuelson named Mar 1, 2022 to Jun 15, 202263
  • DirectorSteven R. Mitchell named Mar 1, 2022 to Jun 15, 202263
  • DirectorKyungwon R. Oh named Mar 1, 202265

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Kineta Chronic Pain, LLC Washington4
  • Kineta Operating, LLC Delaware4
  • Yumanity, Inc. Delaware4

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

Former names

  • YUMANITY THERAPEUTICS, INC.Oct 20, 2020 to Dec 16, 20223
  • PROTEOSTASIS THERAPEUTICS, INC.Aug 14, 2014 to Dec 16, 20203
  • PROTEOSTASIS THERAPEUTICS INCSep 10, 2008 to Jun 2, 20113

Timeline

  1. Jul 1, 20258-K Completed an acquisition or sale; Change to shareholders' rights; Change in control66
  2. Jun 24, 20258-K Shareholder vote; Regulation FD disclosure67
  3. May 7, 20258-K Entered a material agreement68
  4. Mar 28, 20258-K Change of auditor69
  5. Mar 7, 20258-K Unregistered sale of shares70
  6. Feb 10, 20258-K Other events71
  7. Dec 12, 20248-K Entered a material agreement; Regulation FD disclosure72
  8. Nov 25, 20248-K Regulation FD disclosure73
  9. Nov 8, 20248-K Other events74
  10. Oct 8, 20248-K Other events75
  11. Oct 4, 20248-K Other events76
  12. Oct 2, 20248-K Other events77
  13. Dec 20, 2022New chief executive Shawn Iadonato becomes CEO17
  14. Feb 10, 2016New chief executive Meenu Chhabra becomes CEO18
  15. 2006Founded Founded1

Calendar

When it reported results

  1. May 15, 2024Reported quarterly or annual results78
  2. Mar 21, 2024Reported quarterly or annual results79
  3. Nov 3, 2023Reported quarterly or annual results80
  4. Aug 11, 2023Reported quarterly or annual results81
  5. May 11, 2023Reported quarterly or annual results82
  6. Mar 31, 2023Reported quarterly or annual results83
  7. Nov 14, 2022Reported quarterly or annual results84
  8. Aug 4, 2022Reported quarterly or annual results85

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

Filings

341 filings to the SEC since October 2021: 5 annual reports, 11 quarterly reports, 107 major events, 99 insider forms, 20 large holders, 5 private raises, 94 other. The latest 20:

  1. Nov 14, 2025SCHEDULE 13G/A EDGAR
  2. Aug 15, 2025SCHEDULE 13G/A EDGAR
  3. Jul 2, 202515-12G EDGAR
  4. Jul 2, 20254 EDGAR
  5. Jul 2, 20254 EDGAR
  6. Jul 2, 20254 EDGAR
  7. Jul 2, 20254 EDGAR
  8. Jul 2, 20254 EDGAR
  9. Jul 2, 20254 EDGAR
  10. Jul 2, 20254 EDGAR
  11. Jul 2, 20254 EDGAR
  12. Jul 2, 20254 EDGAR
  13. Jul 2, 20254 EDGAR
  14. Jul 1, 2025EFFECT EDGAR
  15. Jul 1, 2025EFFECT EDGAR
  16. Jul 1, 2025EFFECT EDGAR
  17. Jul 1, 2025EFFECT EDGAR
  18. Jul 1, 20258-K EDGAR
  19. Jun 30, 2025S-8 POS EDGAR
  20. Jun 30, 2025S-8 POS EDGAR

The 341 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

34 open-market trades by officers, directors and large owners since October 2021: 17 buys and 17 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Dec 6, 2023Bartoszek Raymond J.DirectorBuy250$4.50$1.1KForm 4
Dec 5, 2023Bartoszek Raymond J.DirectorBuy1,000$4.50$4.5KForm 4
Dec 4, 2023Bartoszek Raymond J.DirectorBuy1,000$4.33$4.3KForm 4
Nov 29, 2023Iadonato ShawnDirectorBuy4,100$3.51$14.4KForm 4
Nov 28, 2023PHILIPS CRAIG W.President and SecretaryBuy3,000$3.27$9.8KForm 4
Nov 28, 2023Iadonato ShawnDirectorBuy900$3.33$3.0KForm 4
Sep 21, 2023PHILIPS CRAIG W.President and SecretaryBuy2,900$2.40$7.0KForm 4
Sep 20, 2023PHILIPS CRAIG W.President and SecretaryBuy600$2.54$1.5KForm 4
Sep 20, 2023Kenny PaulineGeneral Counsel & SecretaryBuy1,500$2.58$3.9KForm 4
Sep 20, 2023Iadonato ShawnDirectorBuy10,000$2.50$25.0KForm 4
Sep 19, 2023Bartoszek Raymond J.DirectorBuy2,000$2.37$4.7KForm 4
Sep 18, 2023Baker KeithChief Financial OfficerBuy5,000$2.13$10.7KForm 4
Sep 18, 2023Bartoszek Raymond J.DirectorBuy2,500$2.08$5.2KForm 4
Sep 15, 2023Bartoszek Raymond J.DirectorBuy500$2.18$1.1KForm 4
Sep 14, 2023Guillaudeux ThierryChief Scientific OfficerBuy10,000$2.00$20.0KForm 4
Jun 16, 2023Baker KeithChief Financial OfficerBuy5,000$2.92$14.6KForm 4
Mar 20, 2023PHILIPS CRAIG W.President and SecretarySale872$3.29$2.9KForm 4
Mar 20, 2023Kenny PaulineGeneral Counsel & SecretarySale544$3.29$1.8KForm 4
Mar 20, 2023Iadonato ShawnDirectorSale1,119$3.29$3.7KForm 4
Mar 17, 2023PHILIPS CRAIG W.President and SecretarySale1,231$4.95$6.1KForm 4

All 34 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.

Money raised

Private offerings the company reported to the SEC on Form D.

  1. Oct 3, 2023Filed a private offering of securities Form D: $2.9 million offered in all Form D
  2. Dec 16, 2022Raised $7.5 million in a private offering of equity Form D: $30 million offered in all Form D
  3. Feb 22, 2022Raised $2.4 million in a private offering of debt Form D: $15 million offered in all Form D
  4. May 28, 2021Raised $17.4 million in a private offering of equity Form D: $27.3 million offered in all Form D

SEC filer profile

How Proteostasis Therapeutics (United States) is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARKINETA, INC./DE2
  • CIK0001445283
  • Employer ID (EIN)20-843665216
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company16
  • Incorporated inDelaware16
  • Fiscal year endsDecember 312
  • Industry code (SIC)2834 Pharmaceutical Preparations2
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
  • Business address7683 Se 27Th Street, Suite 481, Mercer Island, WA 980402
  • Phone(206) 378-04002
  • Shares outstanding13,540,355 as of May 12, 202515
  • Public float$2.5M as of Jun 30, 202416
  • AuditorMarcum LLP, New York, New York PCAOB ID 688; no auditor attestation of internal control over financial reporting16
  • On EDGAR sinceSep 10, 20082
  • Filings813 in all: 4 (227), 8-K (202), 3 (54), 425 (40), SC 13G/A (38), 10-Q (28), SC 13G (21), CORRESP (20)2
    All 50 form types

    EFFECT (17), DEFA14A (15), UPLOAD (14), 424B5 (13), 10-K (10), DEF 14A (9), S-8 (9), S-8 POS (9), S-3 (8), 424B3 (6), 8-K/A (6), D (5), POS AM (5), S-4/A (5), SC 13D/A (5), S-1/A (4), SC 13D (4), SEC STAFF LETTER (4), CT ORDER (3), D/A (3), S-3/A (3), 424B4 (2), ARS (2), S-1 (2), S-4 (2), SCHEDULE 13G/A (2), 10-K/A (1), 15-12G (1), 25-NSE (1), 3/A (1), 424B2 (1), 8-A12B (1), CERTNAS (1), DEFM14A (1), DEFR14A (1), DRS (1), DRS/A (1), FWP (1), POS EX (1), REGDEX (1), S-1MEF (1), SCHEDULE 13G (1)

  • Latest filingsAnnual report (10-K) Mar 6, 2025
    Quarterly report (10-Q) May 15, 2025
    Proxy statement (DEF 14A) Apr 26, 2024
    Latest 8-K (8-K) Jul 1, 2025

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.001 per shareKANT

From the cover page of the 10-K filed Mar 6, 2025 (Section 12(b) of the Exchange Act).16

Risk factors and legal proceedings

The risks Proteostasis Therapeutics (United States) names in Item 1A of its 10-K filed Mar 6, 2025: 75 risks under these headings, as written.16

  • Risks Related to the Mergers
  • Because the Merger Consideration depends on Kineta net working capital at Closing and will not be adjusted in the event of any change in the price of either TuHURA Common Stock or Kineta Common Stock, the market value of the Merger Consideration that Kineta stockholders will receive in the Mergers is uncertain.
  • The market price of TuHURA Common Stock will continue to fluctuate after the Mergers.
  • The market price of TuHURA Common Stock may decline in the future as a result of the sale of shares of TuHURA Common Stock held by former Kineta stockholders or current TuHURA stockholders.
  • The Mergers may not be completed and the Merger Agreement may be terminated in accordance with its terms.
  • The announcement and pendency of the Merger Agreement and any subsequent termination of the Merger Agreement could negatively affect the stock price and the future business and financial results of TuHURA and Kineta.
  • The shares of TuHURA Common Stock to be received by Kineta stockholders as a result of the Mergers will have rights different from the shares of Kineta Common Stock.
  • Satisfying Closing conditions may prevent or delay completion of the Mergers.
  • TuHURA expects to obtain financing in connection with the Mergers and cannot guarantee that it will be able to complete such financing with the expected proceeds.
  • The directors and executive officers of Kineta have interests and arrangements that may be different from, or in addition to, those of Kineta stockholders generally.
  • The Merger Agreement contains provisions that could discourage a potential competing acquirer that might be willing to pay more to acquire Kineta.
  • Each of TuHURA and Kineta will incur significant costs in connection with the Mergers.
The other 64 risks
  • If Kineta does not successfully consummate the Mergers or another strategic transaction, the Kineta Board of Directors may decide to pursue a dissolution and liquidation of Kineta. In such an event, the amount of cash available for distribution to Kineta’s stockholders will depend heavily on the timing of such liquidation as well as the amount of cash that will need to be reserved for commitments and contingent liabilities, as to which Kineta can give you no assurance.
  • Kineta is substantially dependent on Kineta’s remaining employees to facilitate the consummation of the Mergers.
  • Lawsuits filed against TuHURA, Kineta, and members of their respective boards of directors challenging the Mergers, and an adverse ruling in any such lawsuit, may prevent the Mergers from becoming effective or from becoming effective within the expected time frame.
  • The TuHURA bylaws designate a state court located in the State of Nevada and, to the extent enforceable, the U.S. federal district courts in Nevada as the exclusive forums for substantially all disputes between TuHURA and its stockholders, which will restrict the ability of former Kineta stockholders to choose the judicial forum for disputes with TuHURA or its directors, officers or employees.
  • After the Mergers, Kineta stockholders will have a significantly lower ownership and voting interest in TuHURA than they currently have in Kineta and will exercise less influence over management.
  • Risks Relating to the Asset Sales
  • While the Asset Sales are pending, it creates unknown impacts on Kineta’s future which could materially and adversely affect its business, financial condition and results of operations.
  • The failure to consummate the Asset Sales may materially and adversely affect Kineta’s business, financial condition and results of operations.
  • The closing of the Mergers is not conditioned on the consummation of the Asset Sales.
  • Risks Related to Strategic Alternative Process, Potential Strategic Transaction, and Financial Position
  • If Kineta is unable to successfully complete a strategic transaction, Kineta may be forced to cease operations altogether or file for bankruptcy protection.
  • Kineta may not realize any additional value in a strategic transaction.
  • If Kineta is successful in completing a strategic transaction, it may be exposed to other operational and financial risks.
  • Kineta may not fully realize the expected cost savings and/or operating efficiencies from its restructuring activities and its ability to consummate a strategic transaction depends on its ability to retain its employees required to consummate such transaction.
  • Kineta may become involved in securities litigation that could divert management’s attention and harm the Company’s business, and insurance coverage may not be sufficient to cover all costs and damages.
  • Kineta identified conditions and events that raise substantial doubt about its ability to continue as a going concern, Kineta needs substantial additional funding, and if Kineta is unable to raise capital when needed or on favorable terms, its business, financial condition, and results of operation could be materially and adversely affected.
  • Risks Related to Kineta’s Limited Operating History, Financial Position and Capital Requirements
  • Kineta has a limited operating history, has incurred net losses since its inception, and anticipates that it will continue to incur significant losses for the foreseeable future. Kineta may never generate any revenue or become profitable or, if Kineta achieves profitability, may not be able to sustain it.
  • Kineta’s limited operating history may make it difficult for you to evaluate the success of its business to date and to assess Kineta’s future viability.
  • Kineta’s ability to generate revenue and achieve profitability depends significantly on its ability to achieve its objectives relating to the discovery, development and commercialization of Kineta’s product candidates.
  • Kineta will need to obtain substantial additional funding to complete the development and commercialization of its product candidates. If Kineta is unable to raise this capital when needed, Kineta may be forced to delay, reduce or eliminate its product development programs or other operations.
  • Raising additional capital may cause dilution to Kineta’s stockholders, restrict its operations or require Kineta to relinquish rights to its technologies or product candidates.
  • SEC regulations limit the amount of funds that Kineta can raise during any 12-month period pursuant to its shelf registration statement on Form S-3.
  • Kineta has identified material weaknesses in its internal control over financial reporting. If Kineta is unable to remedy its material weaknesses in the future, or if Kineta fails to establish and maintain effective internal controls, Kineta may be unable to produce timely and accurate financial statements. Kineta has concluded that its internal control over financial reporting is ineffective as of December 31, 2024, which could adversely impact Kineta’s investors’ confidence and Kineta’s stock price.
  • Risks Related to the Discovery, Development and Regulatory Approval of Kineta’s Product Candidates
  • Kineta’s development efforts are in the early stages. Kineta’s product candidate is in clinical development. If Kineta is unable to advance its product candidate through clinical development, obtain regulatory approval and ultimately commercialize its product candidate, or experience significant delays in doing so, Kineta’s business will be materially harmed.
  • The results of preclinical studies and early clinical trials are not always predictive of future results. Any product candidate that Kineta advances in clinical trials may not achieve favorable results in later clinical trials, if any, or receive marketing approval.
  • Interim, “topline,” and preliminary data from Kineta’s clinical trials that are announced or published 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.
  • Kineta’s immuno-oncology product candidates are based on novel technologies that target the TME, which makes it difficult to predict the results, timing and cost of product candidate development and likelihood of obtaining regulatory approval.
  • Kineta has initiated clinical trials with its immuno-oncology product, KVA12123. If this product candidate does not show any functionality in the TME, Kineta’s development plans, financial position, results of operations and prospects may be materially adversely affected.
  • Kineta may experience delays or difficulties in the enrollment and/or retention of patients in clinical trials, which could delay or prevent Kineta’s receipt of necessary regulatory approvals.
  • Kineta may not be able to submit INDs to commence additional clinical trials on the timelines Kineta expects and, even if Kineta is able to, the FDA may not permit Kineta to proceed.
  • The regulatory approval processes of the FDA, European Commission (based on recommendation from the EMA), and comparable foreign authorities are lengthy, time consuming and inherently unpredictable. If Kineta is not able to obtain required regulatory approval for its product candidates, Kineta’s business will be substantially harmed.
  • Failure to obtain marketing approval in foreign jurisdictions would prevent Kineta’s product candidates from being marketed abroad. Any approval Kineta may be granted for its product candidates in the United States would not assure approval of its product candidates in foreign jurisdictions and any of its product candidates that may be approved for marketing in a foreign jurisdiction will be subject to risks associated with foreign operations.
  • Kineta’s preclinical studies and clinical trials may fail to demonstrate the safety and efficacy of its product candidates, or serious adverse or unacceptable side effects may be identified during the development of Kineta’s product candidates, which could prevent, delay or limit the scope of regulatory approval of its product candidates, limit their commercialization, increase Kineta’s costs or necessitate the abandonment or limitation of the development of some of Kineta’s product candidates.
  • Preclinical development is uncertain. Kineta’s preclinical program may experience delays or may never advance to clinical trials, which would adversely affect Kineta’s ability to obtain regulatory approvals or commercialize the program on a timely basis or at all, which would have an adverse effect on Kineta’s business.
  • Kineta may encounter substantial delays in the commencement or completion, or termination or suspension, of its clinical trials, which could result in increased costs to Kineta and delay or limit its ability to generate revenue and adversely affect Kineta’s commercial prospects.
  • As an organization, Kineta has never conducted pivotal clinical trials, and Kineta may be unable to do so for any product candidates it may develop.
  • Some data for product candidates comes from clinical trials conducted outside the United States, EU and the UK, and the FDA, EMA or comparable foreign regulatory authorities may not accept data from such trials.
  • Breakthrough therapy designation by the FDA for any product candidate may not lead to a faster development or regulatory review or approval process, and it does not increase the likelihood that the product candidate will receive marketing approval.
  • A Fast Track designation by the FDA, even if granted for other current or future product candidates, may not lead to a faster development or regulatory review or licensure process and does not increase the likelihood that Kineta’s product candidates will receive marketing licensure.
  • Accelerated approval by the FDA, even if granted for Kineta’s current or any other future product candidates, may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that Kineta’s product candidates will receive regulatory approval.
  • Even if Kineta receives regulatory approval for any of its product candidates, Kineta will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense. Additionally, Kineta’s product candidates, if approved, could be subject to post-market study requirements, marketing and labeling restrictions, and even recall or market withdrawal if unanticipated safety issues are discovered following approval. In addition, Kineta may be subject to penalties or other enforcement action if Kineta fails to comply with regulatory requirements.
  • Kineta anticipates that some of its current product candidates and any future product candidates may be used in combination with third-party drugs or biologics, some of which are still in development, and Kineta has limited or no control over the supply, regulatory status or regulatory approval of such drugs or biologics.
  • Kineta may expend its 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.
  • If Kineta does not achieve its projected development goals in the timeframes it announces and expects, the commercialization of its products may be delayed and, as a result, Kineta’s stock price may decline.
  • If Kineta decides to seek Orphan Drug Designation for any of its current or future product candidates, Kineta may be unsuccessful or may be unable to maintain the benefits associated with Orphan Drug Designation, including the potential for supplemental market exclusivity.
  • If Kineta fails to develop additional product candidates, its commercial opportunity could be limited.
  • Kineta’s future growth depends, in part, on its ability to penetrate multiple markets in which Kineta would be subject to additional regulatory burdens and other risks and uncertainties.
  • Risks Related to Manufacturing and Commercialization
  • The manufacture of Kineta’s product candidates is complex and Kineta may encounter difficulties in production, particularly with respect to process development or scaling-out of Kineta’s manufacturing capabilities. If Kineta encounters such difficulties, Kineta’s ability to provide supply of its product candidates for clinical trials or its products for patients, if approved, could be delayed or stopped.
  • Changes in product candidate manufacturing or formulation may result in additional costs or delay.
  • Even if any of Kineta’s 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.
  • Kineta may not be able to successfully commercialize its product candidates, if approved, due to unfavorable pricing regulations or third-party coverage and reimbursement policies, which could make it difficult for Kineta to sell its product candidates profitably.
  • If approved, Kineta’s product candidates that are licensed and regulated as biological products, or biologics, may face competition from biosimilars approved through an abbreviated regulatory pathway.
  • If the market opportunities for any of Kineta’s product candidates are smaller than it believes they are, Kineta’s revenue may be adversely affected, and Kineta’s business may suffer.
  • If any of Kineta’s product candidates are approved for marketing and commercialization and Kineta is unable to establish sales and marketing capabilities or enter into agreements with third parties to sell and market its product candidates, Kineta will be unable to successfully commercialize its product candidates if and when they are approved.
  • Regulatory approval by the FDA, European Commission (based on recommendation from the EMA) or comparable foreign regulatory authorities is limited to those specific indications and conditions for which approval has been granted, and Kineta may be subject to substantial fines, criminal penalties, injunctions or other enforcement actions if Kineta is determined to be promoting the use of its products for unapproved or “off-label” uses or in a manner inconsistent with the approved labeling, resulting in damage to Kineta’s reputation and business.
  • Even if Kineta obtains FDA or European Commission (based on recommendation of the EMA) approval any of its product candidates in the United States or EU, Kineta may never obtain approval for or commercialize any of them in any other jurisdiction, which would limit Kineta’s ability to realize their full market potential.
  • Risks Related to Kineta’s Reliance on Third Parties
  • Some of Kineta’s product candidates may be studied in clinical trials sponsored by organizations or agencies other than Kineta, or in investigator-initiated clinical trials, which means Kineta will have minimal or no control over the conduct of such trials.
  • Kineta relies on third parties to conduct, supervise and monitor its clinical trials and perform some of its research and preclinical studies. If these third parties do not satisfactorily carry out their contractual duties or fail to meet expected deadlines, Kineta’s development programs may be delayed or subject to increased costs, each of which may have an adverse effect on Kineta’s business and prospects.
  • Kineta depends on third-party suppliers for materials that are necessary for the conduct of preclinical studies and manufacture of Kineta’s product candidates for clinical trials, and the loss of these third-party suppliers or their inability to supply Kineta with sufficient quantities of adequate materials, or to do so at acceptable quality levels and on a timely basis, could harm Kineta’s business.
  • If Kineta is unable to obtain sufficient raw and intermediate materials on a timely basis or if Kineta experiences other manufacturing or supply difficulties, Kineta’s business may be adversely affected.
  • Kineta’s reliance on third parties requires Kineta to share its trade secrets, which increases the possibility that a competitor will discover them or that Kineta’s trade secrets will be misappropriated or disclosed.
  • Kineta has already entered into collaborations with third parties for the research, development and commercialization of certain of the product candidates Kineta may develop. Kineta may form or seek additional collaborations or strategic alliances or enter into additional licensing arrangements in the future. If any of these collaborations, strategic alliances or additional licensing arrangements are not successful, Kineta may not be able to capitalize on the market potential of those product candidates.
  • Risks Related to Kineta’s Industry and Business Operations
  • Public health crises, including the COVID-19 pandemic, could have a material adverse impact on Kineta’s business, financial condition and results of operations, including through disruption to Kineta’s planned clinical trials, supply chains, business operations and commercialization efforts, or through delay in the FDA’s approval of Kineta’s product candidates.

Legal proceedings

On March 20, 2024, Kineta filed a complaint in the Court of Chancery of the State of Delaware against Growth & Value Development Inc. (“GVDI”), alleging breach of contract in connection with GVDI’s recent repudiation of its obligation to provide a substantial tranche of funding for Kineta as required under the Securities Purchase Agreement. The complaint provides that Kineta will seek specific performance of GVDI’s

obligations under the Securities Purchase Agreement and damages equal to the amount of the unpaid funding and any damages resulting from GVDI’s breach.

On May 30, 2024, Kineta filed a complaint in the Court of Chancery of the State of Delaware against Myron Wolff, alleging breach of contract in connection with Myron Wolff’s recent repudiation of its obligation to provide a substantial tranche of funding for Kineta as required under the Securities Purchase Agreement. The complaint provides that Kineta will seek specific performance of Myron Wolff’s obligations under the Securities Purchase Agreement and damages equal to the amount of the unpaid funding and any damages resulting from Myron Wolff’s breach.

Except as disclosed in the preceding paragraphs, Kineta is currently not a party to any other material legal proceedings. From time to time, however, Kineta may be a party to litigation or subject to claims incident to the ordinary course of business. Although the results of litigation and claims cannot be predicted with certainty, Kineta currently believes that the final outcome of these ordinary course matters will not have a material adverse effect on Kineta’s business. Regardless of the outcome, litigation can have an adverse impact on Kineta because of defense and settlement costs, diversion of management resources and other factors.

The opening of Item 3, Legal Proceedings.16

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