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TECX on Nasdaq

Tectonic Therapeutic, Inc.

American biological products company based in Watertown1

In its 2026 annual report the company says: “We are a clinical-stage biotechnology company focused on the discovery and development of therapeutic proteins and antibodies that modulate the activity of G-protein coupled receptors. We have developed a proprietary technology platform called GEODe™ (GPCRs Engineered for Optimal Discovery) with the aim of addressing these challenges and enabling the discovery and development of GPCR-targeted biologic medicines that can modify the course of disease.”4 Its shares trade on Nasdaq under the symbol TECX.1

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Last updated Oct 21, 2026.

Overview

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  • TickerTECX on Nasdaq1
  • IndustryBiological Products, (No Diagnostic Substances)1
  • HeadquartersWatertown, Massachusetts1
  • Incorporated inNY2
  • Business address490 Arsenal Way, Suite 200, Watertown, Ma2
  • Filer categoryNon-accelerated filer, Smaller reporting company2
  • Legal formCorporation

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The business and the industry in which Tectonic Therapeutic, Inc. (inclusive of its consolidated subsidiaries, “Tectonic,” the “Company,” “we,” “us,” or “our”) operates is subject to a high degree of uncertainty and risk due to a variety of factors, including those described in the section titled “Risk Factors” and elsewhere in this Annual Report on Form 10-K. These and other factors could cause results to differ materially from those expressed in the estimates made by the independent parties and by Tectonic.4 From its latest annual report

Financials

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

Financial statements

Operating income5678910-$84.0M in 2025+11% since 2019
-$150.0M-$100.0M-$50.0M02019: -$75.8M-$75.8M20192020: -$120.2M-$120.2M2020+59%2021: -$118.8M-$118.8M2021−1%2022: -$105.4M-$105.4M2022−11%2023: -$44.6M-$44.6M2023−58%2024: -$58.0M-$58.0M2024+30%2025: -$84.0M-$84.0M2025+45%
Net income5678910-$74.2M in 2025+2% since 2019
-$150.0M-$100.0M-$50.0M02019: -$73.0M-$73.0M20192020: -$119.7M-$119.7M2020+64%2021: -$119.1M-$119.1M2021−0%2022: -$105.9M-$105.9M2022−11%2023: -$42.8M-$42.8M2023−60%2024: -$58.0M-$58.0M2024+35%2025: -$74.2M-$74.2M2025+28%

Every line of the income statement as filed: the last 2 fiscal years, latest first.10

Period ending2025-12-312024-12-31
Research and development$63.5M$41.4M
General and administrative$20.5M$16.7M
Total operating expenses$84.0M$58.0M
Loss from operations-$84.0M-$58.0M
Interest income$11.3M$4.3M
Interest expense-$63.0K-$107.0K
Change in fair value of SAFE liabilities$0-$3.6M
Other expense-$119.0K-$511.0K
Total other income, net$11.1M$33.0K
Loss before income tax-$72.9M-$58.0M
Income tax expense-$1.2M$0
Net loss-$74.2M-$58.0M
Foreign currency translation adjustment-$105.0K$9.0K
Comprehensive loss-$74.3M-$58.0M
Net loss per share, basic-$4.05-$6.83
Net loss per share, diluted-$4.05-$6.83
Weighted-average common shares outstanding, basic18.3M shares8.5M shares
Weighted-average common shares outstanding, diluted18.3M shares8.5M shares

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Corporate structure

Tectonic Therapeutic, Inc. sits at the top of its group. 5 entities, 3 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Tectonic Therapeutic, Inc.

  • TCG Crossover GP II, LLC Filed SCHEDULE 13G on Tectonic Therapeutic, Inc., latest Feb 27, 2026
  • Aberdeen Group plc Filed SCHEDULE 13G on Tectonic Therapeutic, Inc., latest Jan 29, 2026
  • Deep Track Capital, LP Filed SCHEDULE 13G/A on Tectonic Therapeutic, Inc., latest Nov 14, 2025 (3 filings since Feb 14, 2022)
  • EcoR1 Capital, LLC Filed SCHEDULE 13G/A on Tectonic Therapeutic, Inc., latest Nov 14, 2025 (3 filings since Jul 1, 2024)
  • FMR LLC Filed SCHEDULE 13G/A on Tectonic Therapeutic, Inc., latest May 12, 2025 (4 filings since Jul 10, 2024)
  • Terrance McGuire Filed SCHEDULE 13D/A on Tectonic Therapeutic, Inc., latest Apr 7, 2025 (3 filings since Jun 25, 2024)
  • Timothy A. Springer Filed SCHEDULE 13D/A on Tectonic Therapeutic, Inc., latest Apr 7, 2025 (5 filings since Jun 26, 2024)
  • Vida Ventures II, LLC Filed SCHEDULE 13D/A on Tectonic Therapeutic, Inc., latest Apr 7, 2025 (3 filings since Jun 27, 2024)
  • BML Investment Partners, L.P. Filed SCHEDULE 13G/A on Tectonic Therapeutic, Inc., latest Feb 13, 2025 (4 filings since Jul 24, 2023)
  • Newtyn Management, LLC Filed SC 13G/A on Tectonic Therapeutic, Inc., latest Nov 14, 2024 (2 filings since Feb 14, 2024)
  • Atlas Venture Fund X, L.P. Filed SC 13D/A on Tectonic Therapeutic, Inc., latest Oct 28, 2024
  • ADAR1 Partners, LP Filed SCHEDULE 13G on Tectonic Therapeutic, Inc., latest Feb 23, 2024
  • Tectonic Therapeutic, Inc. Watertown, Massachusetts
    • AVROBIO Australia Pty Ltd Subsidiary · Australia
    • AVROBIO Inc. Subsidiary · Ontario, Canada
    • Tectonic Operating Company, Inc. Subsidiary · Delaware, United States
    • Tectonic Therapeutic Securities Corp. Subsidiary · Massachusetts, 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 Tectonic Therapeutic, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$4.6M10 Dec 31, 2025$4.9M10 Dec 31, 2024−6.2%
Accumulated depreciation$3.4M10 Dec 31, 2025$2.7M10 Dec 31, 2024+24.1%
Property and equipment, net$1.2M10 Dec 31, 2025$2.2M10 Dec 31, 2024−44.9%
Finance-lease assets$495.0K10 Dec 31, 2025$919.0K10 Dec 31, 2024−46.1%
Operating-lease assets (leased space)$874.0K10 Dec 31, 2025$2.2M10 Dec 31, 2024−60.9%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$253.8M10 Dec 31, 2025$141.2M10 Dec 31, 2024+79.7%

Properties, in its own words

Our corporate headquarters are currently located in Watertown, Massachusetts, where we lease approximately 33,000 square feet of research laboratory and office space under a lease that expires in 2029. We believe our current facilities are adequate to meet our present operational needs.

Item 2 of the 10-K filed Feb 26, 2026.4

Leadership

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

Chief executive

  1. Geoffrey Mackay2020–2023
  2. Erik Ostrowski2023–2024
  3. Alise Reicin2024–now

President

  1. Birgitte Volck2018–2020
  2. Geoffrey Mackay2020–2023
  3. Erik Ostrowski2023–2024

Chief financial officer

  1. Katina Dorton2018
  2. Erik Ostrowski2019–2024
  3. Daniel Lochner2024–now

Chief operating officer

  1. Christian Cortis2024
20202025
Board members and other officers (27)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • AVROBIO Australia Pty Ltd Australia3
  • AVROBIO Inc. Ontario, Canada3
  • Tectonic Operating Company, Inc. Delaware3
  • Tectonic Therapeutic Securities Corp. Massachusetts3

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

Former names

  • AvroBio, Inc.Feb 2, 2018 to Jun 18, 20242

Timeline

  1. Sep 29, 20268-K Other events46
  2. Aug 6, 20268-K Results of operations47
  3. Jun 10, 20268-K Shareholder vote; Other events48
  4. May 7, 20268-K Results of operations49
  5. Apr 23, 20268-K Executive or director change; Regulation FD disclosure50
  6. Feb 26, 20268-K Results of operations51
  7. Feb 24, 20268-K Executive or director change; Regulation FD disclosure52
  8. Nov 6, 20258-K Results of operations53
  9. Oct 30, 20258-K Other events54
  10. Aug 7, 20258-K Results of operations; Regulation FD disclosure55
  11. Jun 6, 20258-K Shareholder vote56
  12. May 19, 20258-K Other events57
  13. Jun 24, 2024New chief executive Alise Reicin becomes CEO13
  14. Jul 3, 2023New chief executive Erik Ostrowski becomes CEO14
  15. Mar 6, 2020New chief executive Geoffrey Mackay becomes CEO15

Calendar

Coming up

  1. Nov 5, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($1.02) a share, on Nov 6, 2025.58

When it reported results

  1. Aug 6, 2026Reported quarterly or annual results47
  2. May 7, 2026Reported quarterly or annual results49
  3. Feb 26, 2026Reported quarterly or annual results51
  4. Nov 6, 2025Reported quarterly or annual results53
  5. Aug 7, 2025Reported quarterly or annual results55
  6. May 8, 2025Reported quarterly or annual results59
  7. Mar 20, 2025Reported quarterly or annual results60
  8. Nov 7, 2024Reported quarterly or annual results61

Drug trials and FDA: coming up

  1. Nov 24, 2026Phase 2 trial readout expected Phase 2 trial of TX000045- Dose A and TX000045- Dose B in Pulmonary Hypertension: primary completion expected Nov 24, 2026 (ClinicalTrials.gov NCT06616974).62

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). Trials from ClinicalTrials.gov, as the sponsor registered them (expected dates are the sponsor's own and often move); approvals and advisory committee meetings from the FDA. The FDA does not publish its decision (PDUFA) dates. The full markets calendar

Filings

352 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 57 major events, 137 insider forms, 47 large holders, 1 private raises, 90 other. The latest 20:

  1. Oct 2, 20264 EDGAR
  2. Oct 2, 20264 EDGAR
  3. Oct 2, 20264 EDGAR
  4. Oct 2, 20264 EDGAR
  5. Oct 2, 20264 EDGAR
  6. Sep 30, 2026144 EDGAR
  7. Sep 29, 20268-K EDGAR
  8. Sep 8, 20264 EDGAR
  9. Sep 8, 20264 EDGAR
  10. Sep 8, 20264 EDGAR
  11. Sep 8, 20264 EDGAR
  12. Sep 8, 20264 EDGAR
  13. Aug 27, 2026144 EDGAR
  14. Aug 26, 20264 EDGAR
  15. Aug 21, 2026144 EDGAR
  16. Aug 14, 20264 EDGAR
  17. Aug 12, 2026144 EDGAR
  18. Aug 6, 202610-Q EDGAR
  19. Aug 6, 20268-K EDGAR
  20. Jul 1, 20264 EDGAR

The 352 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

23 open-market trades by officers, directors and large owners since October 2021: 13 buys and 10 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Aug 25, 2026McNamara PeterChief Scientific OfficerSale43$36.52$1.6KForm 4
Aug 12, 2026McNamara PeterChief Scientific OfficerSale43$35.00$1.5KForm 4
Jun 30, 2026McNamara PeterChief Scientific OfficerSale172$35.00$6.0KForm 4
May 4, 2026Ruddy Marcella K.Chief Medical OfficerSale1,065$30.00$31.9KForm 4
Apr 1, 2026Ruddy Marcella K.Chief Medical OfficerSale1,000$31.05$31.1KForm 4
Mar 6, 2026Ruddy Marcella K.Chief Medical OfficerSale10,000$30.00$300.0KForm 4
Mar 6, 2026McNamara PeterChief Scientific OfficerSale6,262$30.17$188.9KForm 4
Mar 4, 2026McNamara PeterChief Scientific OfficerSale1,650$25.00$41.2KForm 4
Mar 3, 2026McNamara PeterChief Scientific OfficerSale1,649$22.06$36.4KForm 4
Feb 11, 2026REICIN ALISEChief Executive OfficerBuy2,500$21.10$52.8KForm 4
Feb 11, 2026REICIN ALISEChief Executive OfficerBuy2,500$21.10$52.8KForm 4
Feb 10, 2026Lochner DanielChief Financial OfficerBuy6,000$21.61$129.7KForm 4
Apr 11, 2025SPRINGER TIMOTHY ADirectorBuy63,184$16.31$1.0MForm 4
Apr 10, 2025SPRINGER TIMOTHY ADirectorBuy53,950$16.73$902.6KForm 4
Apr 9, 2025SPRINGER TIMOTHY ADirectorBuy24,789$14.76$365.9KForm 4
Apr 7, 2025SPRINGER TIMOTHY ADirectorBuy500,000$17.10$8.6MForm 4
Apr 7, 2025MCGUIRE TERRANCEDirectorSale500,000$17.10$8.6MForm 4
Feb 5, 2025SPRINGER TIMOTHY ADirectorBuy789,294$50.68$40.0MForm 4
Feb 5, 2025Lochner DanielChief Financial OfficerBuy4,617$54.14$250.0KForm 4
Oct 22, 2024SPRINGER TIMOTHY ADirectorBuy300,000$33.59$10.1MForm 4

All 23 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
2025Alise ReicinM.D.65$640.8K$7.4M83
2025Daniel LochnerM.B.A.43$488.9K$3.1M83
2025Marcella K. RuddyM.D.63$501.1K$3.1M83
2024PresidentCEO and Director$606.2K$5.9M83
2024Chief Financial Officer$277.1K$2.3M83
2024Chief Medical Officer$476.2K$1.8M83
2024Erik OstrowskiM.B.A.$254.1K$1.1M83

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$185.0M 2025–2025
Money received by yearMoney received by year, 2025–2025: $185.0M in all. Private raises (Form D) $185.0M.$0$50M$100M$150M$200M2025 · Private raises (Form D): $185.0M2025
Figures by year
YearPrivate raises (Form D)Total
2025$185.0M$185.0M

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. Feb 5, 2025Raised $185 million in a private offering of equity84 Form D: 29 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
Fmr LLC2,830,378$97.3M0.0%+13,884
TCG Crossover Management, LLC1,204,891$41.4M1.0%No change
Aberdeen Group plc1,141,824$39.3M0.1%No change
BlackRock, Inc.862,592$29.7M0.0%+2,240
First Light Asset Management, LLC800,726$27.5M1.7%+152,983
Baker Bros. Advisors LP607,788$20.9M0.1%No change
5AM Venture Management, LLC606,660$20.9M7.2%No change
Braidwell LP596,900$20.5M0.8%−250,251
Vanguard Capital Management LLC488,805$16.8M0.0%+15,273
Vestal Point Capital, LP425,000$14.6M0.3%+97,000
Kennedy Capital Management LLC282,202$9.7M0.2%−4,480
Geode Capital Management, LLC270,461$9.3M0.0%+2,188
Orbimed Advisors LLC226,600$7.8M0.1%No change
State Street Corp219,908$7.6M0.0%+6,403
Ikarian Capital, LLC205,837$7.1M1.2%+48,300
D. E. Shaw & Co., Inc.186,550$6.4M0.0%+70,430
Marshall Wace, Llp172,101$5.9M0.0%−57,494
Millennium Management LLC165,525$5.7M0.0%+107,177
Squarepoint Ops LLC145,028$5.0M0.0%−19,391
Ameriprise Financial Inc142,448$4.9M0.0%−984
Wells Fargo & Company/mn117,428$4.0M0.0%+4,764
Northern Trust Corp113,904$3.9M0.0%+35,551
Soleus Capital Management, L.P.101,684$3.5M0.1%−20,000
Woodline Partners LP100,000$3.4M0.0%No change
Vanguard Portfolio Management LLC94,414$3.2M0.0%+30,807

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

SEC filer profile

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

  • Name on EDGARTectonic Therapeutic, Inc.1
  • CIK0001681087
  • Employer ID (EIN)81-07105854
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company4
  • Incorporated inDelaware4
  • Fiscal year endsDecember 311
  • Industry code (SIC)2836 Biological Products, (No Diagnostic Substances)1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address490 Arsenal Way, Suite 200, Watertown, MA1
  • Phone(339) 666-33201
  • Shares outstanding19,549,366 as of Jul 31, 202612
  • Public float$232.0M as of Jun 30, 20254
  • AuditorDeloitte & Touche LLP, Boston, Massachusetts PCAOB ID 34; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceAug 3, 20161
  • Filings578 in all: 4 (183), 8-K (103), 3 (38), 10-Q (25), SC 13G/A (23), SC 13G (17), 144 (16), CORRESP (15)1
    All 45 form types

    424B5 (14), S-8 (14), UPLOAD (12), EFFECT (10), 10-K (8), 425 (8), 424B3 (7), DEF 14A (7), SC 13D/A (7), DEFA14A (6), SC 13D (6), SCHEDULE 13D/A (6), SCHEDULE 13G/A (6), S-3 (4), SCHEDULE 13G (4), 8-K/A (3), ARS (3), D (3), POS AM (3), S-1 (3), S-1/A (3), S-4/A (3), 4/A (2), S-8 POS (2), SEC STAFF LETTER (2), 3/A (1), 424B4 (1), 5 (1), 8-A12B (1), CERT (1), CT ORDER (1), DRS (1), DRS/A (1), DRSLTR (1), RW (1), S-1MEF (1), S-4 (1)

  • Latest filingsAnnual report (10-K) Feb 26, 2026
    Quarterly report (10-Q) Aug 6, 2026
    Proxy statement (DEF 14A) Apr 24, 2026
    Latest 8-K (8-K) Sep 29, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.0001 per shareTECXThe Nasdaq Stock Market LLC

From the cover page of the 10-K filed Feb 26, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Tectonic Therapeutic, Inc. names in Item 1A of its 10-K filed Feb 26, 2026: 74 risks under these headings, as written.4

  • Risks Related to Our Financial Position and Cash Needs
  • We have a limited operating history and have incurred net losses in every year since our inception. We expect to continue to incur net losses in the future.
  • We will need substantial additional funding in order to complete the development and commence commercialization of our product candidates. Failure to obtain this necessary capital when needed may force us to delay, reduce or eliminate certain of our product development or research operations.
  • Raising additional capital will cause dilution to our stockholders, and may restrict our operations, or require us to relinquish rights to our product candidates.
  • Risks Related to the Discovery, Development and Regulatory Approval of Our Product Candidates
  • We have limited experience in therapeutic discovery and development and our GEODe™ platform may never result in the regulatory approval of a product candidate.
  • We are early in our development efforts. If we are unable to advance TX45, TX2100 or any of our other product candidates through clinical development, obtain regulatory approval and ultimately commercialize TX45, TX2100 or any of our other product candidates, or experience significant delays in doing so, our business will be materially harmed.
  • All of our product candidates are in discovery, preclinical or Phase 1 and Phase 2 clinical trials. Clinical trials are difficult to design and implement, and they involve a lengthy and expensive process with uncertain outcomes. We may experience delays in completing, or ultimately be unable to complete, the development and commercialization of TX45, TX2100 or any future product candidates.
  • Our clinical trials may fail to demonstrate substantial evidence of the safety, efficacy, purity and potency of our product candidates or any future product candidates, which would prevent or delay or limit the scope of regulatory approval and commercialization.
  • The results of preclinical studies and early-stage clinical trials of our product candidates may not be predictive of the results of later-stage clinical trials. Initial success in our ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later-stage trials.
  • Our product candidates may be associated with serious adverse, undesirable or unacceptable side effects or other properties or safety risks, which may delay or halt their clinical development, or prevent marketing approval. If such side effects are identified during the development of our product candidates or following approval, we may suspend or abandon our development of such product candidates, the commercial profile of any approved label may be limited, or we may be subject to other significant negative consequences following marketing approval.
  • We may find it difficult to enroll patients in our clinical trials, which could delay or prevent us from proceeding with, or otherwise adversely affect, clinical trials of our product candidates.
The other 63 risks
  • Interim, topline and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • Preclinical development is uncertain. Our preclinical programs may experience delays or may never advance to clinical trials, which would adversely affect our ability to obtain regulatory approvals or commercialize these programs on a timely basis or at all, which would have an adverse effect on our business.
  • The regulatory approval processes of the FDA and comparable foreign regulatory authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed.
  • The FDA and any comparable foreign regulatory authorities may not accept data from trials conducted in locations outside of their jurisdiction.
  • Even if we receive regulatory approval of a product candidate, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with such product candidate.
  • If approved, our investigational products may face competition from biosimilars approved through an abbreviated regulatory pathway.
  • We may become exposed to costly and damaging liability claims, either when testing our product candidates in the clinic or at the commercial stage, and our product liability insurance may not cover all damages from such claims.
  • Due to our limited resources and access to capital, we prioritize development of certain product candidates over other potential product candidates. These decisions may prove to have been wrong and may adversely affect our ability to develop our own programs, our attractiveness as a commercial partner and may ultimately have an impact on our commercial success.
  • We may seek orphan drug designation for product candidates we develop, and we may be unsuccessful or may be unable to maintain the benefits associated with orphan drug designation, including the potential for market exclusivity.
  • Risks Related to Commercialization of Our Product Candidates
  • If we are unable to successfully commercialize any product candidate for which we receive regulatory approval, or experience significant delays in doing so, our business will be materially harmed.
  • We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.
  • We do not have a sales or marketing infrastructure and have no experience in the sale or marketing of biotechnology products. To achieve commercial success for any approved product, we must develop or acquire a sales and marketing organization, outsource these functions to third parties or enter into strategic collaborations.
  • Even if a product candidate we develop receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success. The revenues that we generate from our sales may be limited, and we may never become profitable.
  • Healthcare reform may negatively impact our ability to profitably sell TX45, TX2100 and any potential future product candidates, if approved.
  • Inadequate funding for the FDA and other government agencies, including from government shutdowns, or other disruptions to these agencies’ operations, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
  • Our relationships with healthcare providers, customers and third-party payors will be subject to applicable anti-kickback, fraud and abuse, transparency and other healthcare laws and regulations, which, if violated, could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens and diminished profits and future earnings.
  • Our business could be materially and adversely affected in the future by political unrest in China.
  • International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospects.
  • General supply chain issues may be exacerbated during disease outbreaks, epidemics and pandemics and may also impact the ability of our clinical trial sites to obtain basic medical supplies used in our trials in a timely fashion, if at all.
  • Our estimates of market opportunity and forecasts of market growth may prove to be inaccurate, and even if the markets in which we compete achieve the forecasted growth, our business may not grow at similar rates, or at all.
  • Even if we obtain approval to market TX45, TX2100 or other potential future product candidates, these products may become subject to unfavorable pricing regulations, reimbursement practices from third-party payors or healthcare reform initiatives in the United States and abroad, which could harm our business.
  • Risks Related to Our Intellectual Property
  • Our success depends in part on our ability to protect our intellectual property. It is difficult and costly to protect our proprietary rights and technology, and we may not be able to ensure their protection.
  • We depend on intellectual property licensed from third parties and termination of any of these licenses could result in the loss of significant rights, which would harm our business.
  • If we fail to comply with our obligations under our patent licenses with a third party, we could lose license rights that are important to our business.
  • If we are unable to protect the confidentiality of our proprietary information, our business and competitive position would be harmed.
  • Third-party claims of intellectual property infringement may prevent or delay our product discovery and development efforts.
  • Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or misappropriated proprietary information.
  • We may not be successful in obtaining or maintaining necessary rights to develop any future product candidates on acceptable terms.
  • We may be involved in lawsuits related to our patents or the patents of our licensors, which could be expensive, time-consuming and unsuccessful.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • Issued patents covering our product candidates could be found invalid or unenforceable if challenged in court or the USPTO.
  • Changes in patent law in the U.S. and in ex-U.S. jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • We may not be able to protect our intellectual property rights throughout the world.
  • We may incur substantial costs as a result of litigation or other proceedings relating to patents, and we may be unable to protect our rights to our products and technology.
  • Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.
  • If we do not obtain patent term extension and data exclusivity for any product candidates we may develop, our business may be materially harmed.
  • If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
  • Risks Related to Our Reliance on Third Parties
  • We currently rely on and expect to rely on in the future on the use of manufacturing suites in third-party facilities or on third parties to manufacture TX45, TX2100 and any other product candidates, and we may rely on third parties to produce and process our products, if approved. Our business could be adversely affected if we are unable to use third-party manufacturing suites or if the third-party manufacturers encounter difficulties in production.
  • We rely, and expect to continue to rely, on third parties, including independent clinical investigators, contracted laboratories and CROs, to conduct our preclinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our product candidates and our business could be substantially harmed.
  • Our future collaborations will be important to our business. If we are unable to enter into new collaborations, or if these collaborations are not successful, our business could be adversely affected.
  • Nonclinical research requires the use of Non-Human Primates (“NHP”), the supply of which could delay or prevent development of product candidates.
  • Risks Related to Our Business Operations, Employee Matters and Managing Growth
  • Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.
  • We may become exposed to costly and damaging liability claims, either when testing a product candidate in the clinical or at the commercial stage, and our product liability insurance may not cover all damages from such claims.
  • Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.
  • Failure to comply with health-related data protection laws and regulations could lead to government enforcement actions, including civil or criminal penalties, private litigation, and adverse publicity and could negatively affect our operating results and business.
  • Our employees, principal investigators, consultants, and commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading.
  • If our information technology systems, or the information technology systems of our CROs, our CDMOs, service providers, our current and potential future partners or other third parties with whom we work fail or suffer security breaches, we could experience adverse consequences, including but not limited to material disruptions to our business operations and product development programs, regulatory investigations or actions, litigation, fines and penalties, reputational harm, loss of revenue or profits, or other adverse consequences.
  • We are subject to U.S. and certain foreign anti-corruption laws and regulations, export and import controls, sanctions and embargoes. We could face liability and other serious consequences for violations which can harm our business.
  • We or the third parties upon whom we depend may be adversely affected by earthquakes, fires or other natural disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
  • Legislation or other changes in U.S. tax law could adversely affect our business and financial condition.
  • Our ability to use our U.S. net operating loss carryforwards and certain other U.S. tax attributes may be limited.
  • Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and stock price.
  • Future changes in financial accounting standards or practices may cause adverse and unexpected revenue fluctuations and adversely affect our reported results of operations.
  • If we or any CDMOs and suppliers we engage fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.
  • We incur significantly increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives.
  • Once we are no longer a smaller reporting company or otherwise no longer qualify for applicable exemptions, we will be subject to additional laws and regulations affecting public companies that will increase our costs and the demands on management and could harm our operating results and cash flows.
  • Failure to build our finance infrastructure and improve our accounting systems and controls could impair our ability to comply with the financial reporting and internal controls requirements for publicly traded companies.
  • Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
  • Stockholders previously filed lawsuits, which were subsequently dismissed, relating to the Merger; however, additional lawsuits could be filed.
  • Risks Related to Ownership of Our Common Stock
  • The market price of our common stock has been and is likely to continue to be volatile and fluctuate substantially.
  • Sales of our common stock or the perception of such sales, by us or selling stockholders, in the public market or otherwise, could cause the market price for our securities to decline, even though selling stockholders would still realize a profit on sales at lower prices. Resales of the securities offered may cause the market price of such securities to drop significantly, even if our business is doing well.
  • Our executive officers, directors and principal stockholders have the ability to control or significantly influence all matters submitted to our stockholders for approval.
  • If equity research analysts do not publish research or reports, or publish unfavorable research or reports, about us, our business or our market, our stock price and trading volume could decline.

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