CATX on NYSE

Perspective Therapeutics, Inc.

In its 2026 annual report the company says: “We are a radiopharmaceutical development company pioneering advanced treatments for cancers throughout the body. We have proprietary technology that utilizes the alpha-emitting isotope Lead-212 ( 212 Pb) to deliver powerful radiation specifically to cancer cells via specialized targeting moieties. We are also developing complementary imaging diagnostics that incorporate the same targeting moieties, which provides the opportunity to personalize treatment and optimize patient outcomes.”3 It is headquartered in Seattle, Washington.1 Its shares trade on NYSE under the symbol CATX.1

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Last updated Oct 21, 2026.

Overview

Compare with AVENUE THERAPEUTICS, INC., Cleveland BioLabs or Northwest Biotherapeutics, or pick any stock.

  • TickerCATX on NYSE1
  • IndustryPharmaceutical Preparations1
  • HeadquartersSeattle, Washington1
  • Incorporated inDE2
  • Business address2401 Elliott Avenue, Suite 320, Seattle, Wa 981212
  • Filer categoryNon-accelerated filer, Smaller reporting company2
  • Legal formCorporation

We are a radiopharmaceutical development company pioneering advanced treatments for cancers throughout the body. We have proprietary technology that utilizes the alpha-emitting isotope Lead-212 ( 212 Pb) to deliver powerful radiation specifically to cancer cells via specialized targeting moieties. We are also developing complementary imaging diagnostics that incorporate the same targeting moieties, which provides the opportunity to personalize treatment and optimize patient outcomes. This theranostic approach enables the ability to see the specific tumor and then treat it to potentially improve efficacy and minimize toxicity.3 From its latest annual report

Financials

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

Key numbers, fiscal 2023

100.0%Gross margin4
-2855.0%Operating margin5
-3243.2%Net margin5
-61.9%Return on equity6
0.02×Debt to equity4
-$38.0MFree cash flow5

Where the money goes

Where each dollar of revenue went, fiscal 2023

  • Research and development89¢$21.3M
  • Interest0¢$84.0K
  • Income tax11¢$2.7M

Out of $1.4M in revenue.45 The company lost money this year.

Financial statements

Revenue784$1.4M in 2023−80% since 2019
0$5.0M$10.0M$15.0M2019: $7.3M$7.3M20192020: $9.7M$9.7M2020+32%2021: $10.1M$10.1M2021+4%2022: $0$020222023: $1.4M$1.4M2023
Gross profit784$1.4M in 2023−53% since 2019
0$2.0M$4.0M$6.0M2019: $3.0M$3.0M20192020: $5.1M$5.1M2020+68%2021: $5.1M$5.1M2021−0%2022: $0$020222023: $1.4M$1.4M2023
Operating income7845-$40.9M in 2023+679% since 2019
-$60.0M-$40.0M-$20.0M02019: -$5.3M-$5.3M20192020: -$3.5M-$3.5M2020−34%2021: -$3.4M-$3.4M2021−1%2022: -$8.7M-$8.7M2022+152%2023: -$40.9M-$40.9M2023+372%
Net income7845-$46.5M in 2023+804% since 2019
-$60.0M-$40.0M-$20.0M02019: -$5.1M-$5.1M20192020: -$3.4M-$3.4M2020−33%2021: -$3.4M-$3.4M2021−2%2022: -$10.8M-$10.8M2022+218%2023: -$46.5M-$46.5M2023+332%

Every line of the income statement as filed: the last 2 fiscal years, latest first.6

Period ending2025-12-312024-12-31
Grant revenue$884.0K$1.5M
Research and development$84.2M$41.6M
General and administrative$30.2M$26.6M
Goodwill impairment$0$24.1M
Loss on disposal of property and equipment$0$27.0K
Total operating expenses$114.4M$92.3M
Operating loss-$113.6M-$90.9M
Interest income$8.1M$10.5M
Interest and other expense-$376.0K-$48.0K
Other income from a related party (Note 3)$1.4M$0
Equity in loss of affiliate-$2.0K-$8.0K
Total non-operating income, net$9.1M$10.5M
Net loss from continuing operations-$104.4M-$80.4M
Net gain (loss) from discontinued operations$514.0K-$949.0K
Net loss before deferred income tax benefit-$103.9M-$81.4M
Deferred income tax benefit$793.0K$2.1M
Net loss-$103.1M-$79.3M
Loss from continuing operations, Basic-$1-$1
Loss from continuing operations, Diluted-$1-$1
Gain (loss) from discontinued operations, Basic$0-$0
Gain (loss) from discontinued operations, Diluted$0-$0
Basic loss per share-$1.40-$1.23
Diluted loss per share-$1.40-$1.23
Basic73.8M shares64.4M shares
Diluted73.8M shares64.4M shares
Unrealized gain (loss) on available-for-sale securities$161.0K-$51.0K
Comprehensive loss-$103.0M-$79.3M

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Corporate structure

Perspective 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 Perspective Therapeutics, Inc.

  • Lantheus Holdings, Inc. Filed SCHEDULE 13D/A on Perspective Therapeutics, Inc., latest Sep 23, 2026 (4 filings since Feb 1, 2024)
  • MILLENNIUM MANAGEMENT LLC Filed SCHEDULE 13G/A on Perspective Therapeutics, Inc., latest Aug 13, 2026 (3 filings since Jun 30, 2026)
  • State Street Corporation Filed SCHEDULE 13G on Perspective Therapeutics, Inc., latest Aug 7, 2026
  • BlackRock Filed SCHEDULE 13G on Perspective Therapeutics, Inc., latest Jul 29, 2026 (4 filings since Oct 24, 2024)
  • Morgan Stanley Filed SCHEDULE 13G/A on Perspective Therapeutics, Inc., latest May 12, 2026 (2 filings since Feb 12, 2026)
  • Avidity Partners Management LP Filed SCHEDULE 13G on Perspective Therapeutics, Inc., latest Mar 10, 2026 (3 filings since Nov 14, 2024)
  • Commodore Capital LP Filed SCHEDULE 13G on Perspective Therapeutics, Inc., latest Feb 9, 2026 (3 filings since Apr 19, 2024)
  • TCG Crossover GP II, LLC Filed SCHEDULE 13G on Perspective Therapeutics, Inc., latest Feb 6, 2026
  • Qatar Investment Authority Filed SCHEDULE 13G on Perspective Therapeutics, Inc., latest Feb 5, 2026
  • FMR LLC Filed SCHEDULE 13G/A on Perspective Therapeutics, Inc., latest Dec 5, 2025 (4 filings since Nov 7, 2024)
  • Janus Henderson Group Ltd. Filed SCHEDULE 13G/A on Perspective Therapeutics, Inc., latest Feb 14, 2025 (2 filings since Nov 14, 2024)
  • Frances Johnson Filed SCHEDULE 13G/A on Perspective Therapeutics, Inc., latest Feb 5, 2024 (2 filings since Sep 19, 2023)
  • Perspective Therapeutics, Inc. Seattle, Washington

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

What it owns

What Perspective 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
Computer equipment and software$90.0K6 Dec 31, 2025$90.0K6 Dec 31, 20240%
Property and equipment, before depreciation$82.8M6 Dec 31, 2025$60.3M6 Dec 31, 2024+37.4%
Accumulated depreciation$6.2M6 Dec 31, 2025$3.0M6 Dec 31, 2024+109.6%
Property and equipment, net$76.6M6 Dec 31, 2025$57.3M6 Dec 31, 2024+33.6%
Operating-lease assets (leased space)$1.5M6 Dec 31, 2025$2.2M6 Dec 31, 2024−32.3%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$30.6M6 Dec 31, 2025$61.6M6 Dec 31, 2024−50.3%
Marketable securities, current$114.1M6 Dec 31, 2025$165.3M6 Dec 31, 2024−31.0%
Debt securities available for sale$114.1M6 Dec 31, 2025$165.3M6 Dec 31, 2024−31.0%
Stakes in other companies (equity method)$124.0K6 Dec 31, 2025$126.0K6 Dec 31, 2024−1.6%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$06 Dec 31, 2024$24.1M5 Dec 31, 2023−100.0%
Intangible assets, net (excluding goodwill)$362.0K6 Dec 31, 2025$279.0K6 Dec 31, 2024+29.7%
Indefinite-lived intangibles (excluding goodwill)$40.0M6 Dec 31, 2025$50.0M6 Dec 31, 2024−20.0%
Finite-lived intangibles, gross$448.0K6 Dec 31, 2025$358.0K6 Dec 31, 2024+25.1%
Accumulated amortization$86.0K6 Dec 31, 2025$79.0K6 Dec 31, 2024+8.9%
Finite-lived intangibles, net$4.0K6 Dec 31, 2025$11.0K5 Dec 31, 2024−63.6%

Properties, in its own words

The Company’s executive offices are located at 2401 Elliott Avenue, Suite 320, Seattle, WA 98121, where it leases approximately 6,400 square feet of office space for approximately $9,125 per month subject to increases as defined in the lease agreement plus the Company’s share of taxes and common area expenses. The lease terminates in October 2028.

In February 2026, the Company renewed a lease for approximately 17,500 square feet of mainly laboratory space through March 2028 for approximately $54,240 per month in Coralville, IA, and in November 2025, the Company entered into a three-year lease agreement for approximately 5,000 square feet of office space, also in Coralville, IA, for approximately $6,400 per month.

The rest of Item 2

The Company acquired a lease from Progenics, an affiliate of Lantheus, for a production facility in Somerset, NJ, effective on March 1, 2024. The lease expense is approximately $7,400 per month for approximately 11,400 square feet for sole and exclusive use, 700 square feet of common space and approximately 500 square feet of joint use space (each as defined in the agreement). The lease terminates in November 2028.

In 2024, the Company purchased a 27,375 square foot building in the Houston, TX, metropolitan area for $4.7 million, a 41,588 square foot building in the Chicago, IL, metropolitan area for $5.0 million, and a 28,662 square foot building in the Los Angeles, CA, metropolitan area for $11.0 million, all of which the Company intends to use for the manufacture of its program candidates upon completion of modifications and installation of equipment.

In August 2024, the Company assumed a lease from Progenics for office space in Somerset, NJ (Office). The lease terminates in November 2028. The Office lease expense is approximately $14,000 per month for 8,200 square feet. Upon assuming the lease, the Company entered into a license and access agreement with Lantheus, which provides access to both dedicated and shared space of the Office of approximately 1,700 square feet and 1,150 square feet, respectively.

In April 2024, the Company completed the divestiture of the brachytherapy division which included the production facility located at 350 Hills St., Ste. 106, Richland, WA 99352 where it leased approximately 15,300 square feet of office and manufacturing space for approximately $25,900 per month. This lease and associated payment obligations were assigned to GT Medical Technologies, Inc. as part of the divestiture.

In December 2022, the Company completed the purchase of a 20,000 square foot building located in Coralville, IA, that has laboratory space.

In 2017, the Company purchased approximately 4.2 acres of land in Richland, WA, in anticipation of constructing a facility for its discontinued brachytherapy operations. In connection with the divestiture of the brachytherapy operations, the Company disposed of this land in October 2024.

Item 2 of the 10-K filed Mar 16, 2026.3

Leadership

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

Board members and other officers (25)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive OfficerJonathan Hunt named Feb 21, 2023 to Mar 18, 202446

Former names

  • IsoRay, Inc.Oct 31, 2018 to Feb 16, 20232
  • CENTURY PARK PICTURES CORPAug 22, 1995 to Aug 3, 20052

Timeline

  1. Oct 8, 20268-K Other events47
  2. Oct 1, 20268-K Other events48
  3. Sep 14, 20268-K Other events49
  4. Sep 8, 20268-K Other events50
  5. Aug 10, 20268-K Results of operations; Other events51
  6. Aug 3, 20268-K Other events52
  7. Jul 1, 20268-K Other events53
  8. Jun 1, 20268-K Other events54
  9. May 27, 20268-K Shareholder vote55
  10. May 22, 20268-K Other events56
  11. May 11, 20268-K Results of operations; Other events57
  12. May 4, 20268-K Results of operations; Other events58
  13. Feb 13, 2023New chief executive Johan M. Spoor becomes CEO12
  14. Jun 19, 2018New chief executive Lori A. Woods becomes CEO13
  15. Feb 19, 2016New chief executive Thomas C. Lavoy becomes CEO14
  16. May 19, 2008New chief executive Dwight William Babcock becomes CEO15
  17. Aug 10, 2006New chief executive Roger Girard becomes CEO16

Calendar

Coming up

  1. Nov 9, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.35) a share, on Nov 10, 2025.59

When it reported results

  1. Aug 10, 2026Reported quarterly or annual results51
  2. May 11, 2026Reported quarterly or annual results57
  3. May 4, 2026Reported quarterly or annual results58
  4. Mar 16, 2026Reported quarterly or annual results60
  5. Feb 2, 2026Reported quarterly or annual results61
  6. Jan 9, 2026Reported quarterly or annual results62
  7. Nov 10, 2025Reported quarterly or annual results63
  8. Oct 20, 2025Reported quarterly or annual results64

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

Filings

340 filings to the SEC since October 2021: 6 annual reports, 15 quarterly reports, 118 major events, 104 insider forms, 32 large holders, 3 private raises, 62 other. The latest 20:

  1. Oct 8, 20268-K EDGAR
  2. Oct 1, 20268-K EDGAR
  3. Sep 23, 2026SCHEDULE 13D/A EDGAR
  4. Sep 14, 20268-K EDGAR
  5. Sep 8, 20264 STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES EDGAR
  6. Sep 8, 20268-K EDGAR
  7. Sep 4, 20264 STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES EDGAR
  8. Sep 4, 20264 STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES EDGAR
  9. Sep 4, 2026SCHEDULE 13D/A EDGAR
  10. Sep 3, 20264 STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES EDGAR
  11. Sep 2, 20264 STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES EDGAR
  12. Aug 13, 2026SCHEDULE 13G/A EDGAR
  13. Aug 10, 202610-Q EDGAR
  14. Aug 10, 20268-K EDGAR
  15. Aug 7, 2026SCHEDULE 13G EDGAR
  16. Aug 3, 20268-K EDGAR
  17. Jul 29, 2026SCHEDULE 13G EDGAR
  18. Jul 20, 2026SCHEDULE 13G EDGAR
  19. Jul 1, 20268-K EDGAR
  20. Jun 30, 2026SCHEDULE 13G EDGAR

The 340 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

50 open-market trades by officers, directors and large owners since October 2021: 43 buys and 7 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 4, 2026Lantheus Alpha Therapy, LLC10% ownerSale167,149$3.15$526.5KForm 4
Sep 3, 2026Lantheus Alpha Therapy, LLC10% ownerSale80,783$3.11$251.2KForm 4
Sep 2, 2026Lantheus Holdings, Inc.10% ownerSale42,129$3.11$131.0KForm 4
Sep 1, 2026Lantheus Alpha Therapy, LLC10% ownerSale35,769$3.12$111.6KForm 4
Sep 1, 2026Lantheus Holdings, Inc.10% ownerSale35,769$3.12$111.6KForm 4
Aug 31, 2026Lantheus Alpha Therapy, LLC10% ownerSale78,145$3.14$245.4KForm 4
Aug 31, 2026Lantheus Holdings, Inc.10% ownerSale78,145$3.14$245.4KForm 4
Nov 13, 2025Hunt Jonathan RobertChief Accounting OfficerBuy11,000$2.03$22.3KForm 4
Nov 12, 2025Williamson Robert F IIIDirectorBuy9,498$2.10$19.9KForm 4
Mar 31, 2025Williamson Robert F IIIDirectorBuy38,145$2.14$81.6KForm 4
Mar 31, 2025Woods Lori ADirectorBuy23,475$2.13$50.0KForm 4
Mar 28, 2025Spoor Johan M.Chief Executive OfficerBuy26,676$2.23$59.6KForm 4
Mar 28, 2025Williamson Robert F IIIDirectorBuy22,192$2.27$50.4KForm 4
Mar 28, 2025Graham JuanChief Financial OfficerBuy33,333$2.25$75.0KForm 4
Dec 4, 2024HENSON HEIDIDirectorBuy25,975$3.85$100.0KForm 4
Dec 4, 2024Spoor Johan M.Chief Executive OfficerBuy8,000$3.77$30.2KForm 4
Nov 25, 2024Williamson Robert F IIIDirectorBuy6,266$3.64$22.8KForm 4
Nov 25, 2024Hunt Jonathan RobertChief Accounting OfficerBuy12,829$3.82$49.0KForm 4
Nov 25, 2024Spoor Johan M.Chief Executive OfficerBuy26,500$3.79$100.4KForm 4
Jun 17, 2024Hunt Jonathan RobertChief Accounting OfficerBuy1,800$9.82$17.7KForm 4

All 50 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
2025Johan (Thijs) Spoor54$680.0K$2.4M78
2025Juan Graham$334.7K$2.2M78
2025Joel Sendek59$163.0K$2.0M78
2025Markus PuhlmannM.D.60$516.7K$1.1M78
2024CEO and Director$630.0K$5.4M78
2024Chief Medical Officer$496.8K$2.0M78

Money raised

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

  1. Mar 4, 2024Raised $87.4 million in a private offering of equity Form D: 9 investors so far Form D
  2. Jan 8, 2024Raised $20.8 million in a private offering of equity Form D: 1 investor so far Form D
  3. Feb 3, 2023Raised $54.6 million in a private offering of equity Form D: 54 investors so far Form D

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
BlackRock, Inc.9,494,152$32.4M0.0%+4,145,591
TCG Crossover Management, LLC7,915,567$27.0M0.6%No change
Commodore Capital LP6,336,782$21.6M1.3%No change
Avidity Partners Management LP6,299,999$21.5M3.4%−5,799,999
State Street Corp6,051,771$20.6M0.0%+2,919,101
Millennium Management LLC4,911,855$16.7M0.0%+865,215
Nantahala Capital Management, LLC4,650,900$15.9M0.5%New
Vanguard Capital Management LLC4,436,572$15.1M0.0%+57,616
Affinity Asset Advisors, LLC4,214,582$14.4M0.7%+1,050,000
Citadel Advisors LLC3,805,739$13.0M0.0%+239,235
Spruce Street Capital LP3,693,931$12.6M2.5%+1,066,824
Balyasny Asset Management L.P.3,320,224$11.3M0.0%+325,764
Geode Capital Management, LLC2,458,673$8.4M0.0%+691,713
Morgan Stanley1,912,550$6.5M0.0%−1,070,792
Goldman Sachs Group Inc1,733,078$5.9M0.0%+491,262
Nicholson Wealth Management Group, LLC1,619,993$5.5M3.3%+1,000
Two Sigma Investments, LP1,556,451$5.3M0.0%+552,977
ADAR1 Capital Management, LLC1,210,117$4.1M0.2%+460,782
Vanguard Portfolio Management LLC1,087,767$3.7M0.0%+335,734
Dimensional Fund Advisors LP1,074,071$3.7M0.0%+623,974
Yu Fan1,055,409$3.6M3.3%No change
Hills Bank & Trust Co872,200$3.0M0.1%No change
Northern Trust Corp791,774$2.7M0.0%+262,846
Charles Schwab Investment Management Inc773,262$2.6M0.0%+111,944
Ally Bridge Group (NY) LLC743,958$2.5M3.3%−182,599

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

SEC filer profile

How Perspective 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 EDGARPerspective Therapeutics, Inc.1
  • CIK0000728387
  • Employer ID (EIN)41-14581523
  • Filer statusNon-accelerated filer not 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 address2401 Elliott Avenue, Suite 320, Seattle, WA 981211
  • Phone206-676-09001
  • Shares outstanding114,151,663 as of Aug 5, 202610
  • Public float$212.9M as of Jun 30, 20253
  • AuditorWithumSmith+Brown, PC, San Francisco, CA, USA PCAOB ID 100; no auditor attestation of internal control over financial reporting3
  • On EDGAR sinceAug 22, 19951
  • Filings1,140 in all: 8-K (326), 4 (286), 10-Q (76), 424B5 (40), 3 (34), CT ORDER (27), 10-K (24), EFFECT (22)1
    All 58 form types

    DEF 14A (21), DEFA14A (18), 10QSB (17), UPLOAD (16), 4/A (13), 8-K/A (13), SC 13G (13), SC 13G/A (13), POS AM (12), S-8 (12), SD (12), CORRESP (11), S-3 (10), SCHEDULE 13G (9), SCHEDULE 13G/A (9), SB-2/A (8), REGDEX/A (7), 10KSB (6), REGDEX (6), SC 13D (6), 10-K/A (5), 10QSB/A (5), NT 10-Q (5), PRE 14A (5), S-8 POS (5), D (4), S-3/A (4), SC 13D/A (4), AW (3), NT 10-K (3), NTN 10K (3), S-3MEF (3), 10-Q/A (2), 10KSB/A (2), 424B3 (2), FWP (2), SB-2 (2), SCHEDULE 13D/A (2), 10-KT (1), 144 (1), 8-A12B (1), 8-A12G (1), CERTAMX (1), DEFM14A (1), POS EX (1), POSASR (1), PREM14A (1), S-1 (1), S-1/A (1), S-3ASR (1)

  • Latest filingsAnnual report (10-K) Mar 16, 2026
    Quarterly report (10-Q) Aug 10, 2026
    Proxy statement (DEF 14A) Apr 16, 2026
    Latest 8-K (8-K) Oct 8, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.001 par valueCATXNYSE American

From the cover page of the 10-K filed Mar 16, 2026 (Section 12(b) of the Exchange Act).3

Risk factors and legal proceedings

The risks Perspective Therapeutics, Inc. names in Item 1A of its 10-K filed Mar 16, 2026: 35 risks under these headings, as written.3

  • Risks Related to Our Business, Financial Results and Need for Additional Capital
  • We are a clinical-stage biopharmaceutical company and have a limited operating history upon which to base an investment decision.
  • We will require substantial additional capital to fund our operations. Additional funds may be dilutive to shareholders or impose operational restrictions. Further, if additional capital is not available, we may need to delay, limit or eliminate our research, development and commercialization programs and modify our business strategy.
  • We have incurred losses in nearly every year since our inception, and we anticipate that we will not achieve profits for the foreseeable future.
  • Risks Related to Our Business and Industry
  • Our product candidates are in early stages of development and must go through clinical trials, which are very expensive, time consuming and difficult to design and implement. The outcomes of clinical trials are uncertain, and delays in the completion or termination of any clinical trial of our product candidates could harm our business, financial condition and prospects.
  • We rely on single vendors to provide supplies and services used in the development and production of our alpha-particle therapies.
  • We may be required to suspend, repeat or terminate our clinical trials if they are not conducted in accordance with regulatory requirements, the results are negative or inconclusive, or the trials are not well designed.
  • The approval processes of regulatory authorities are lengthy, time consuming, expensive and inherently unpredictable; if we experience unanticipated delays or are unable to obtain approval for our product candidates from applicable regulatory authorities, we will not be able to market and sell those product candidates in those countries or regions, and our business will be substantially harmed.
  • Disruptions at the FDA, including a lapse in appropriations and/or decreased funding for the FDA, could prevent the FDA from performing functions on which our business relies, which could negatively impact our business.
  • We receive federal funding to conduct certain research on our product candidates and other programs, and recent federal policy changes could disrupt that funding.
  • We may not be successful in managing the build-out of our manufacturing facilities and associated costs or satisfying manufacturing-related regulatory requirements.
The other 25 risks
  • We rely on third parties to conduct our clinical trials, and if these third parties do not meet their deadlines or otherwise conduct the trials as required, our clinical development programs could be delayed or unsuccessful, and we may not be able to obtain regulatory approval for or commercialize our product candidates when expected or at all.
  • We have in-sourced part of the research, development, and clinical operations functions previously assigned to CROs, and we may not be able to efficiently execute those operations, or the cost savings expected from this transition may not materialize, which may adversely affect the financial performance of our business or our ability to advance our pipeline.
  • We may seek orphan drug designation, rare pediatric disease designation, or other FDA designations, but may not receive such designation. Even if the FDA grants the designation, we may not receive orphan drug exclusivity or a priority review voucher if the product candidate does not meet the FDA requirements at the time of approval or licensure.
  • Coverage and adequate reimbursement may not be available for our product candidates, if commercialized, which could make it difficult for us to sell any future products profitably.
  • Due to the significant resources required for the development of our drug candidates, we must prioritize development of certain drug candidates and/or certain disease indications and may expend our limited resources on candidates or indications that do not yield a successful product and fail to capitalize on drug candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • Legal and Regulatory Risks Related to Our Operations
  • We are subject to a variety of global privacy laws, rules and regulations, and our failure to comply with them could harm our business.
  • If we fail to comply with global data protection laws and regulations, we could be subject to government enforcement actions (which could include civil or criminal penalties), private litigation and/or adverse publicity, which could negatively affect our operating results and business.
  • If we fail to comply with applicable healthcare regulations, we could face substantial penalties, and our business, operations and financial condition could be adversely affected.
  • Changes in U.S. and international trade policies may adversely impact our business and operating results.
  • Healthcare reform measures could hinder our product candidates’ commercial success.
  • If, once we offer commercialized products, we participate in the Medicaid Drug Rebate Program and other governmental pricing programs, failure to comply with obligations under these programs could result in additional price concession requirements, penalties, sanctions and fines, which could have a material adverse effect on our business, operations and financial condition.
  • Our business exposes us to product liability claims.
  • Our business involves environmental risks.
  • Fluctuations in insurance cost and availability could adversely affect our profitability or our risk management profile.
  • Risks Related to Intellectual Property Matters
  • We may be unable to adequately obtain, protect, enforce or defend our intellectual property rights or to secure and maintain rights to third-party intellectual property necessary for the development and commercialization of our product candidates and other programs.
  • Potential patent litigation could be costly and disruptive and may have an adverse effect on our business, financial condition and results of operations.
  • The value of our granted patents and our pending patents is uncertain.
  • Some of the intellectual property that is important to our business is owned by third parties and licensed to us, and changes in or termination of our rights under these license agreements may adversely impact our business.
  • We may be subject to claims that we or our employees, consultants, contractors or advisors have infringed, misappropriated or otherwise violated the intellectual property of a third party, or claiming ownership of what we regard as our own intellectual property.
  • Some of our technology is subject to “march-in” rights by the U.S. government.
  • Risks Related to Ownership of Shares of Common Stock and Public Company Status
  • The concentration of our common share ownership will likely limit the ability of other shareholders to influence corporate matters.
  • Our stock price has been and may continue to be volatile.
  • The price of our Common Stock may be adversely affected by the future issuance and sale of shares of our Common Stock or other equity securities.
  • We do not expect to pay any dividends for the foreseeable future.

Legal proceedings

The Company may, in the ordinary course of business, be involved in legal proceedings involving securities, contractual and employment relationships, product liability claims, patent rights, environmental matters, and a variety of other matters, the outcomes of which are not within the Company’s complete control and may not be known for extended periods of time. Legal costs associated with defending these matters are expensed as incurred. The Company is only involved in ordinary routine litigation incidental to its business.

The opening of Item 3, Legal Proceedings.3

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