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CNSY on Nasdaq

Plus Therapeutics

Logo: plustherapeutics.com3

Plus Therapeutics is a biopharmaceutical company based in Austin, founded in 1996.1 Its shares trade on Nasdaq under the symbol CNSY.1

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Last updated Oct 21, 2026.

Overview

1996Founded1

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  • TickerCNSY on Nasdaq1
  • IndustrySurgical & Medical Instruments & Apparatus1
  • HeadquartersAustin1
  • Websiteplustherapeutics.com
  • Incorporated inDE4
  • Business address6420 Levit Green Boulevard, Suite 310, Houston, Tx 770214
  • Filer categoryNon-accelerated filer, Smaller reporting company4
  • Legal formCorporation

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Plus Therapeutics image from its website
Image: plustherapeutics.com3

Plus Therapeutics is a U.S. healthcare company developing and commercializing precision diagnostics and targeted radiopharmaceuticals for central nervous system (“CNS”) cancers. CNSide Diagnostics, LLC (“CNSide Diagnostics”) is our wholly owned subsidiary that develops and commercializes proprietary laboratory-developed tests, such as CNSide®, designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas. In radiopharmaceuticals, our lead candidate, rhenium ( 186 Re) obisbemeda, is designed specifically for CNS cancers including recurrent glioblastoma (“GBM”), leptomeningeal metastases (“LM”), and pediatric brain cancers (“PBC”) by direct localized delivery utilizing approved standard-of-care tissue access such as with convection-enhanced delivery (“CED”) and intraventricular brain (Ommaya reservoir) catheters. Our acquire…6 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 2025

-293.5%Operating margin7
-429.4%Net margin7
-10.5%Revenue growth, 20257
-560.2%Return on equity7
-$20.8MFree cash flow7

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development100¢$8.4M

Out of $5.2M in revenue.7 The company lost money this year.

Financial statements

Revenue87$5.2M in 2025+6% since 2023
0$2.0M$4.0M$6.0M2023: $4.9M$4.9M20232024: $5.8M$5.8M2024+19%2025: $5.2M$5.2M2025−10%
Operating income910111287-$15.3M in 2025+318% since 2019
-$20.0M-$15.0M-$10.0M-$5.0M02019: -$3.7M-$3.7M20192020: -$9.6M-$9.6M2020+162%2021: -$12.5M-$12.5M2021+30%2022: -$19.7M-$19.7M2022+58%2023: -$13.3M-$13.3M2023−32%2024: -$14.7M-$14.7M2024+10%2025: -$15.3M-$15.3M2025+4%
Net income910111287-$22.4M in 2025+106% since 2019
-$30.0M-$20.0M-$10.0M02019: -$10.9M-$10.9M20192020: -$8.2M-$8.2M2020−24%2021: -$13.4M-$13.4M2021+63%2022: -$20.3M-$20.3M2022+51%2023: -$13.3M-$13.3M2023−34%2024: -$13.0M-$13.0M2024−3%2025: -$22.4M-$22.4M2025+72%

Every line of the income statement as filed: the last 2 fiscal years, latest first.7

Period ending2025-12-312024-12-31
Revenue$5.2M$5.8M
Research and development$8.4M$10.6M
General and administrative$12.1M$9.9M
Total operating expenses$20.5M$20.5M
Operating loss-$15.3M-$14.7M
Financing expense-$3.1M-$3.5M
Change in fair value of derivative instruments-$2.6M$5.7M
Warrant issuance costs-$964.0K-$486.0K
Interest income$116.0K$273.0K
Interest expense-$548.0K-$179.0K
Total other income (expense)-$7.1M$1.7M
Net loss-$22.4M-$13.0M
Net loss per share of common stock - basic-$0.29-$1.95
Net loss per share of common stock - diluted-$0.29-$2.34
Weighted average number of shares of common stock outstanding - basic77.8M shares6.6M shares
Weighted average number of shares of common stock outstanding - diluted77.8M shares7.7M shares

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Corporate structure

Plus Therapeutics sits at the top of its group. 2 entities, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Plus Therapeutics

  • Plus Therapeutics Austin
    • CNSide Diagnostics, LLC 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 Plus Therapeutics 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
Leasehold improvements$1.8M7 Dec 31, 2025$1.8M7 Dec 31, 20240%
Property and equipment, before depreciation$3.6M7 Dec 31, 2025$3.6M7 Dec 31, 2024+0.1%
Accumulated depreciation$3.3M7 Dec 31, 2025$3.1M7 Dec 31, 2024+6.2%
Property and equipment, net$257.0K7 Dec 31, 2025$448.0K7 Dec 31, 2024−42.6%
Operating-lease assets (leased space)$70.0K7 Dec 31, 2025$73.0K7 Dec 31, 2024−4.1%

Real estate and locations

ItemLatestA year beforeChange
Area of land11,370 sq ft7 Oct 16, 2025

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$4.3M7 Dec 31, 2025$76.0K7 Dec 31, 2024+5500.0%
Marketable securities, current$4.4M7 Dec 31, 2025$3.5M7 Dec 31, 2024+23.4%
Debt securities available for sale$4.4M7 Dec 31, 2025

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$372.0K7 Dec 31, 2025$372.0K7 Dec 31, 20240%
Finite-lived intangibles, gross$767.0K8 Dec 31, 2024$221.0K8 Dec 31, 2023+247.1%
Accumulated amortization$298.0K8 Dec 31, 2024$179.0K8 Dec 31, 2023+66.5%
Finite-lived intangibles, net$333.0K7 Dec 31, 2025$469.0K7 Dec 31, 2024−29.0%

Properties, in its own words

Our corporate offices are in Houston, Texas. As of December 31, 2025, we had lease agreements for office space in Charlottesville, Virginia and Houston, Texas.

On October 16, 2025, we entered into a lease (the “Houston Lease”) with LG 1 Property Owner LP, pursuant to which we agreed to lease approximately 11,370 rentable square feet of space located at 6420 Levit Green Boulevard, Houston, Texas 77021. The Houston Lease is expected to commence on or about November 1, 2026. The Houston Lease provides for a monthly base rent of $58,745, which increases annually by approximately 3%, plus our share of the building’s direct expenses. The Houston Lease has an initial term of 120 calendar months.

Item 2 of the 10-K filed Mar 12, 2026.6

Leadership

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

Chief executive

  1. Christopher J. Calhoun2006–2014
  2. Marc H. Hedrick2014–now

President

  1. Marc H. Hedrick2006–2018
  2. Norio Seijiro Shirahama2007–2015

Chief financial officer

  1. Mark E. Saad2006–2014
  2. Tiago Girao2014–2018
200020052010201520202025
Board members and other officers (32)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Chief Financial OfficerAndrew H. Sims named Sep 18, 202654
  • DirectorAn H. van Es-Johansson named Sep 18, 202654

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • CNSide Diagnostics, LLC Delaware5

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

Former names

  • PLUS THERAPEUTICS, INC.Feb 8, 2019 to Jul 1, 20264
  • CYTORI THERAPEUTICS, INC.May 26, 2005 to Aug 2, 20194
  • MACROPORE INCJul 16, 2001 to Jul 5, 20054

Timeline

  1. Oct 2, 20268-K Other events55
  2. Sep 10, 20268-K Entered a material agreement; New debt or obligation; Unregistered sale of shares56
  3. Aug 14, 20268-K Results of operations57
  4. Aug 4, 20268-K Bylaws or fiscal year changed58
  5. Jun 5, 20268-K Entered a material agreement59
  6. May 15, 20268-K Results of operations60
  7. May 15, 20268-K Shareholder vote61
  8. Apr 21, 20268-K Other events62
  9. Apr 9, 20268-K Executive or director change63
  10. Apr 8, 20268-K Other events64
  11. Apr 2, 20268-K Change to shareholders' rights; Bylaws or fiscal year changed; Other events65
  12. Mar 26, 20268-K Executive or director change66
  13. Apr 15, 2014New chief executive Marc H. Hedrick becomes CEO16
  14. Jan 26, 2006New chief executive Christopher J. Calhoun becomes CEO17
  15. 2000Went public Listed on NASDAQ1
  16. 1996Founded Founded1

Calendar

Coming up

  1. Oct 29, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported $1 a share, on Oct 30, 2025.67

When it reported results

  1. Aug 14, 2026Reported quarterly or annual results57
  2. May 15, 2026Reported quarterly or annual results60
  3. Mar 12, 2026Reported quarterly or annual results68
  4. Oct 30, 2025Reported quarterly or annual results69
  5. Aug 14, 2025Reported quarterly or annual results70
  6. May 30, 2025Reported quarterly or annual results71
  7. Mar 27, 2025Reported quarterly or annual results72
  8. Nov 14, 2024Reported quarterly or annual results73

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

Filings

319 filings to the SEC since October 2021: 6 annual reports, 15 quarterly reports, 79 major events, 110 insider forms, 14 large holders, 1 private raises, 94 other. The latest 20:

  1. Oct 2, 20268-K EDGAR
  2. Oct 1, 20264 EDGAR
  3. Oct 1, 20264 EDGAR
  4. Oct 1, 20264 EDGAR
  5. Oct 1, 20264 EDGAR
  6. Oct 1, 20264 EDGAR
  7. Oct 1, 20264 EDGAR
  8. Oct 1, 20264 EDGAR
  9. Sep 18, 2026D EDGAR
  10. Sep 10, 20268-K EDGAR
  11. Aug 14, 202610-Q EDGAR
  12. Aug 14, 20268-K EDGAR
  13. Aug 4, 20268-K EDGAR
  14. Jul 1, 20264 EDGAR
  15. Jul 1, 20264 EDGAR
  16. Jul 1, 20264 EDGAR
  17. Jul 1, 20264 EDGAR
  18. Jul 1, 20264 EDGAR
  19. Jul 1, 20264 EDGAR
  20. Jul 1, 20264 EDGAR

The 319 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

40 open-market trades by officers, directors and large owners since October 2021: 38 buys and 2 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Nov 4, 2025Sims Andrew John Hugh MacIntyreChief Financial OfficerBuy20,000$0.51$10.2KForm 4
Aug 22, 2025Lenk Robert PDirectorBuy110,000$0.49$53.9KForm 4
Sep 13, 2024Hawkins Richard JDirectorBuy4,000$1.50$6.0KForm 4
Sep 12, 2024Hawkins Richard JDirectorBuy6,285$1.35$8.5KForm 4
Sep 11, 2024Petersen GregDirectorBuy12,500$1.35$16.9KForm 4
Sep 11, 2024Clowes HowardDirectorBuy5,000$1.34$6.7KForm 4
Sep 10, 2024HEDRICK MARC HChief Executive OfficerBuy8,000$1.23$9.8KForm 4
Sep 10, 2024Sims Andrew John Hugh MacIntyreChief Financial OfficerBuy4,098$1.27$5.2KForm 4
May 8, 2024Sims Andrew John Hugh MacIntyreChief Financial OfficerBuy4,902$2.04$10.0KForm 4
May 8, 2024HEDRICK MARC HChief Executive OfficerBuy12,255$2.04$25.0KForm 4
May 8, 2024Petersen GregDirectorBuy12,255$2.04$25.0KForm 4
May 8, 2024Hawkins Richard JDirectorBuy4,902$2.04$10.0KForm 4
May 8, 2024Clowes HowardDirectorBuy9,804$2.04$20.0KForm 4
May 8, 2024Lenk Robert PDirectorBuy4,167$2.04$8.5KForm 4
Nov 20, 2023HEDRICK MARC HChief Executive OfficerSale2,068$1.96$4.1KForm 4
Nov 16, 2023Lenk Robert PDirectorBuy1,000$1.95$1.9KForm 4
Nov 15, 2023Lenk Robert PDirectorBuy1,000$1.77$1.8KForm 4
Nov 13, 2023Lenk Robert PDirectorBuy4,000$1.43$5.7KForm 4
Nov 10, 2023Lenk Robert PDirectorBuy2,000$1.45$2.9KForm 4
Nov 9, 2023Lenk Robert PDirectorBuy4,199$1.59$6.7KForm 4

All 40 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
2025Marc H. HedrickM.D.64$585.0K$5.6M82
2025Andrew Sims53$390.0K$1.6M82
2024President and Chief Executive Officer$556.4K$1.3M82
2024Chief Financial Officer$372.8K$621.1K82
2024Former Chief Medical Officer$258.4K$285.9K82

Funding

Where the company's money came from, by calendar year: private offerings filed with the SEC, federal grants, loans, contracts and other assistance from USAspending.gov, and PPP loans from the SBA. Each bar links to the records below.

Money received by year$40.6M 2012–2026
Money received by yearMoney received by year, 2012–2026: $40.6M in all. Private raises (Form D) $3.0M; Federal grants $3.0M; Federal contracts $34.6M.$0$5M$10M$15M2012 · Federal contracts: $4.7M20122014 · Federal contracts: $14.1M20142016 · Federal contracts: $2.5M20162017 · Federal contracts: $13.4M2018202020222024 · Federal grants: $3.0M20242026 · Private raises (Form D): $3.0M2026
Without federal contracts$6.0M 2024–2026
Without federal contractsWithout federal contracts, 2024–2026: $6.0M in all. Private raises (Form D) $3.0M; Federal grants $3.0M.$0$1M$2M$3M2024 · Federal grants: $3.0M202420252026 · Private raises (Form D): $3.0M2026
Figures by year
YearPrivate raises (Form D)Federal grantsFederal contractsTotal
2026$3.0M––$3.0M
2024–$3.0M–$3.0M
2017––$13.4M$13.4M
2016––$2.5M$2.5M
2014––$14.1M$14.1M
2012––$4.7M$4.7M

Private raises

Private offerings the company reported to the SEC on Form D. The amount is what the latest filing says was sold so far, charted in the year of the first sale. Covers filings since Oct 1, 2021.

  1. Sep 10, 2026Raised $3 million in a private offering of securities54 Form D: $20 million offered in all Form D

Federal awards

Obligated amounts from USAspending.gov83, by calendar year, 2012–2024, for its registration. Obligations are what agencies committed, not always what was paid out. Contracts pay for goods and services; grants, loans and direct payments are assistance. Loans are charted at the face value of the loans listed here. An award’s amount below is its lifetime total, and some began before the years charted.

Largest grants

  1. Sep 1, 2024$3.0M from Defense Health Agency: Military Medical Research And Development84 To PLUS THERAPEUTICS, INC. Award HT94252411035

Held by these funds

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

FundSharesValueShare of the fundChange
Vanguard Capital Management LLC304,745$1.3M0.0%New
BlackRock, Inc.95,983$419.4K0.0%New
Geode Capital Management, LLC76,155$332.9K0.0%New
Vanguard Fiduciary Trust Co36,868$161.1K0.0%New
Ashton Thomas Private Wealth, LLC34,306$149.9K0.0%New
Citadel Advisors LLC25,597$111.9K0.0%New
Northern Trust Corp15,516$67.8K0.0%New
Wells Fargo & Company/mn6,156$26.9K0.0%New
Vanguard Global Advisers, LLC2,282$10.0K0.0%New
Osaic Holdings, Inc.2,000$8.7K0.0%New
Tower Research Capital LLC (TRC)1,955$8.5K0.0%New
UBS Group AG470$2.1K0.0%New
Allied Private Wealth LLC496$1.9K0.0%New
SBI Securities Co., Ltd.251$1.1K0.0%−2,393
Morgan Stanley185$8080.0%New
Barclays PLC96$4200.0%New
Citigroup Inc17$740.0%New
Virtu Financial LLC15,343$670.0%New
Caitong International Asset Management Co., Ltd12$520.0%New
Hrt Financial LP11,612$500.0%New
Global Retirement Partners, LLC4$170.0%New

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

SEC filer profile

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

  • Name on EDGARCERENOME, INC.2
  • CIK0001095981
  • Employer ID (EIN)33-08275936
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company6
  • Incorporated inDelaware6
  • Fiscal year endsDecember 312
  • Industry code (SIC)3841 Surgical & Medical Instruments & Apparatus2
  • SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance2
  • Business address6420 Levit Green Boulevard, Suite 310, Houston, TX 770212
  • Phone737.255.71942
  • Shares outstanding7,589,625 as of Aug 5, 202614
  • Public float$31.9M as of Jun 30, 20256
  • AuditorCBIZ CPAs P.C., New York, NY PCAOB ID 199; no auditor attestation of internal control over financial reporting6
  • On EDGAR sinceMar 30, 20012
  • Filings1,463 in all: 4 (519), 8-K (350), 10-Q (76), 3 (39), UPLOAD (36), CORRESP (35), SC 13G/A (33), EFFECT (29)2
    All 54 form types

    424B3 (28), DEF 14A (27), 10-K (25), 424B5 (23), SC 13G (23), 4/A (18), S-1 (17), S-3 (14), PRE 14A (12), ARS (11), 5 (10), S-1/A (10), S-8 (10), 10-K/A (9), FWP (8), DEFA14A (7), 10-Q/A (6), 424B4 (6), S-3/A (6), 3/A (5), CT ORDER (5), SCHEDULE 13G/A (5), DEFR14A (4), RW (4), SCHEDULE 13G (4), SD (4), 10-12G/A (3), 25-NSE (3), 424B2 (3), 8-A12B (3), 8-K/A (3), D (3), DRS (3), REGDEX (3), SC 13D/A (3), CERTNAS (2), NT 10-Q (2), POS AM (2), PRER14A (2), S-1MEF (2), S-3MEF (2), SC 13D (2), 10-12G (1), 144 (1), 8-A12G (1), CERT (1)

  • Latest filingsAnnual report (10-K) Mar 12, 2026
    Quarterly report (10-Q) Aug 14, 2026
    Proxy statement (DEF 14A) Mar 31, 2026
    Latest 8-K (8-K) Oct 2, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.001 per sharePSTVNasdaq

From the cover page of the 10-K filed Mar 12, 2026 (Section 12(b) of the Exchange Act).6

Risk factors and legal proceedings

The risks Plus Therapeutics names in Item 1A of its 10-K filed Mar 12, 2026: 63 risks under these headings, as written.6

  • Risks Related to our Financial Position and Capital Requirements
  • We have incurred losses since inception, we expect to incur significant net losses in the foreseeable future and we may never become profitable and our operating results have been and will likely continue to be volatile.
  • Uncertainties relating to our ability to fund our operations raises substantial doubt about our ability to continue as a going concern.
  • We could be delisted from Nasdaq for failure to comply with the Minimum Stockholders’ Equity Requirement, the Minimum Bid Requirement or other applicable continued listing requirements and standards of Nasdaq, which would seriously harm the liquidity of our stock and our ability to raise capital.
  • Potential Consequences of Delisting
  • We will need substantial additional funding to develop our product candidates and conduct our future operations and to repay our outstanding debt obligations. If we are unable to obtain the funds necessary to do so, we may be required to delay, scale back or eliminate our product development activities or may be unable to continue our business operations.
  • We maintain our cash at financial institutions, often in balances that exceed federally insured limits.
  • Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.
  • Risks Related to Our Business and Industry
  • If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired.
  • Our future success is in large part dependent upon our ability to successfully develop our nanomedicine platform and commercialize rhenium (186Re) obisbemeda and 188RNL-BAM and any failure to do so could significantly harm our business and prospects.
  • 188RNL-BAM will be regulated as a medical device, which may result in additional regulatory and other risks.
The other 54 risks
  • We recently acquired the CNSide Portfolio, and we may not be successful in our efforts to develop, fully utilize and monetize it.
  • If we are unable to successfully partner with other companies to commercialize our product candidates, our business could materially suffer.
  • Our success depends in substantial part on our ability to obtain regulatory clearance, authorization or approval for our RNL product candidates. However, we cannot be certain that we will receive regulatory clearance, authorization or approval for these product candidates or our other product candidates.
  • If we or any party to a key collaboration, licensing, development, acquisition or similar arrangement fail to perform material obligations, or commit a breach, under such arrangement, or any arrangement is terminated for any reason, there could be an adverse effect on our business.
  • Our current business strategy is high-risk and may not be successful.
  • Reliance on government funding for our programs may impose requirements that limit our ability to take certain actions, and subject it to potential financial penalties, which could materially and adversely affect our business, financial condition and results of operations.
  • The DoD Award is dependent on continued U.S. government funding and government appropriations, which may not be forthcoming on a timely basis or at all.
  • If our competitors market or develop products that are marketed more effectively, approved more quickly than our product candidates, or demonstrated to be safer or more effective than our product candidates, our commercial opportunities could be reduced or eliminated.
  • Product development involves a lengthy 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 and commercialization of our product candidates.
  • Preclinical studies and preliminary and interim data from clinical trials of our product candidates are not necessarily predictive of the results or success of ongoing or future clinical trials of our product candidates.
  • Because we have limited resources, we may decide to pursue a particular product candidate and fail to advance product candidates that later demonstrate a greater chance of clinical and commercial success.
  • Clinical trial results may fail to support approval of our product candidates.
  • If third parties we engage are not able to successfully perform, we may not be able to successfully complete clinical development, obtain regulatory approval or commercialize our product candidates and our business could be substantially harmed.
  • We may have difficulty enrolling, or fail to enroll patients, in our clinical trials, which could delay or prevent clinical trials of our drug candidates.
  • If a particular product candidate causes significant adverse events, then we may be unable to receive regulatory approval or market acceptance for such product candidate.
  • If our product candidates and technologies receive regulatory approval but do not achieve broad market acceptance, especially by physicians, the revenue that we generate will be limited.
  • All potential applications of our product candidates are investigational, which subjects us to development and marketing risks.
  • We and our product candidates are subject to extensive regulation, and the requirements to obtain regulatory approvals in the United States and other jurisdictions can be costly, time-consuming and unpredictable. If we or our partners are unable to obtain timely regulatory approval for our product candidates, our business may be substantially harmed.
  • We will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant expense, and if we or our collaborators fail to comply with such requirements, regulatory agencies may take action against us or them, which could significantly harm our business.
  • The future regulatory processes that will be applicable to LDTs are uncertain and may prevent us from obtaining required authorizations for the commercialization of our products and/or introduce additional costs associated with those products.
  • Changing, new and/or emerging government regulations, including healthcare legislative reform measures, may adversely affect us.
  • Healthcare reform measures could hinder or prevent the commercial success of our LDTs or any product candidate for which we obtain regulatory approval.
  • Adequate coverage and reimbursement from third party payors may not be available for our product candidates, which could diminish our sales or adversely affect our ability to sell our products profitably.
  • Some intellectual property that we have in-licensed has been discovered through government funded programs and thus may be subject to federal regulations such as “march-in” rights, certain reporting requirements and a preference for U.S.-based companies. Compliance with such regulations may limit our exclusive rights and limit our ability to contract with non-U.S. manufacturers.
  • Orphan drug designation may not ensure that we will enjoy market exclusivity in a particular market, and if we fail to obtain or maintain orphan drug designation or other regulatory exclusivity for some of our product candidates, our competitive position would be harmed.
  • Fast Track Designation by the FDA may not lead to a faster development or regulatory review or approval process.
  • A Rare Pediatric Disease designation by the FDA does not guarantee that the NDA for the product will qualify for a priority review voucher upon approval, and it does not lead to a faster development or regulatory review process, or increase the likelihood that rhenium (186Re) obisbemeda or our future product candidates will receive marketing approval.
  • If we decide to pursue accelerated approval for any of our product candidates, it may not lead to a faster development or regulatory review or approval process and does not increase the likelihood that our product candidates will receive marketing approval.
  • If we experience an interruption in supply from a material sole source supplier, our business may be harmed.
  • We may engage in strategic transactions that could impact our liquidity, increase our expenses, and present significant distractions to our management.
  • We must maintain quality controls and compliance with manufacturing standards.
  • If we are unable to identify, hire and/or retain key personnel, we may not be able to sustain or grow our business.
  • We face potential product liability exposure, and if successful claims are brought against us, we may incur substantial liability if our insurance coverage for those claims is inadequate.
  • A failure to adequately protect health information could result in severe harm to our reputation and subject us to significant liabilities, each of which could have a material adverse effect on our business.
  • We and our collaborators must comply with environmental laws and regulations, including those pertaining to use of hazardous and biological materials in our business, and failure to comply with these laws and regulations could expose us to significant liabilities.
  • We may not be successful in our efforts to develop, fully utilize and monetize the CNSide diagnostic portfolio.
  • Clinical laboratories are highly regulated and if we are unable to maintain compliance with these regulations, or if the regulations change in ways that make it more difficult or costly to comply, our financial condition and our business may be harmed.
  • Our relationships with customers, healthcare providers, including physicians, and third-party payors are subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws, and other healthcare laws and regulations. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.
  • The diagnostic testing industry is subject to rapid change, which could make our current or future products obsolete.
  • Risks Relating to Our Intellectual Property
  • Our success depends in part on our ability to protect our intellectual property.
  • If we do not obtain patent term extension for any product candidates we may develop, our business may be materially harmed.
  • We may not be able to protect our trade secrets.
  • We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
  • We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights, and we may be unable to protect our rights to our product candidates and technology.
  • If we are sued for infringing intellectual property rights of third parties, it will be costly and time consuming, and an unfavorable outcome in that litigation would have a material adverse effect on our business.
  • Risks Relating to the Issuance of Capital Stock, the Securities Markets and an Investment in Our Common Stock
  • Our stockholders may experience substantial dilution in the value of their investment if we issue additional shares of our capital stock.
  • The market price of our common stock may be volatile and fluctuate significantly, which could result in substantial losses for stockholders.
  • We may be or become the target of securities litigation, which is costly and time-consuming to defend.
  • We may issue debt and equity securities or securities convertible into equity securities, any of which may be senior to our common stock as to distributions and in liquidation, which could negatively affect the value of our common stock.
  • Our charter documents contain anti-takeover provisions.
  • We presently do not intend to pay cash dividends on our common stock.
  • If securities and/or industry analysts fail to continue publishing research about our business, if they change their recommendations adversely, or if our results of operations do not meet their expectations, our stock price and trading volume could decline.
  • General Risk Factors
  • Increased information technology security threats and more sophisticated and targeted computer crime could pose a risk to our systems, networks, and products.

Sources

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    Company websitePlus Therapeutics logo
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    SEC EDGAROther events
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