PYXS on Nasdaq

Pyxis Oncology, Inc.

In its 2026 annual report the company says: “Pyxis Oncology is a clinical-stage oncology company advancing a development strategy focused on addressing unmet medical needs in patients with solid tumors with an immediate focus on head and neck squamous cell carcinoma (HNSCC).”3 It is headquartered in Boston, Massachusetts.1 Its shares trade on Nasdaq under the symbol PYXS.1

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Last updated Oct 21, 2026.

Overview

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  • TickerPYXS on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersBoston, Massachusetts1
  • Incorporated inDE2
  • Business address321 Harrison Avenue, Boston, Ma 021182
  • Filer category, Emerging growth company2

Pyxis Oncology is a clinical-stage oncology company advancing a development strategy focused on addressing unmet medical needs in patients with solid tumors with an immediate focus on head and neck squamous cell carcinoma (HNSCC).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 2025

-609.2%Operating margin4
-574.5%Net margin4
-14.2%Revenue growth, 20254
-149.1%Return on equity4
-$63.5MFree cash flow4

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Products and services

Sale of Royalty Rights brought in 80% of the revenue Pyxis Oncology, Inc. broke down this way in fiscal 2025.

  1. Sale of Royalty Rights$11.0M480%up 38% from 2024
  2. Milestone Revenue$2.8M420%
Products and services by year
Products and services20242025
Sale of Royalty Rights$8.0M$11.0M
Milestone Revenue$0$2.8M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue3¢$2.4M
  • Research and development95¢$73.7M
  • Income tax2¢$1.4M

Out of $13.9M in revenue.4 The company lost money this year.

Financial statements

Revenue4$13.9M in 2025−14% since 2024
0$5.0M$10.0M$15.0M$20.0M2024: $16.1M$16.1M20242025: $13.9M$13.9M2025−14%
Operating income56784-$84.4M in 2025+555% since 2020
-$150.0M-$100.0M-$50.0M02020: -$12.9M-$12.9M20202021: -$69.7M-$69.7M2021+441%2022: -$123.5M-$123.5M2022+77%2023: -$82.2M-$82.2M2023−33%2024: -$89.5M-$89.5M2024+9%2025: -$84.4M-$84.4M2025−6%
Net income56784-$79.6M in 2025+521% since 2020
-$150.0M-$100.0M-$50.0M02020: -$12.8M-$12.8M20202021: -$76.0M-$76.0M2021+492%2022: -$120.7M-$120.7M2022+59%2023: -$73.8M-$73.8M2023−39%2024: -$77.3M-$77.3M2024+5%2025: -$79.6M-$79.6M2025+3%

Every line of the income statement as filed: the last 2 fiscal years, latest first.4

Period ending2025-12-312024-12-31
Revenues$13.9M$16.1M
Cost of revenues$2.4M$475.0K
Research and development$73.7M$58.7M
General and administrative$22.2M$25.4M
Impairment of in-process research and development intangible asset$0$21.0M
Total costs and operating expenses$98.3M$105.6M
Loss from operations-$84.4M-$89.5M
Interest and investment income, net$3.6M$7.0M
Sublease income$2.6M$2.9M
Total other income, net$6.2M$10.0M
Income (Loss) from Continuing Operations before Income Taxes, Noncontrolling Interest, Total-$78.2M-$79.5M
Income tax expense (benefit)$1.4M-$2.2M
Net loss-$79.6M-$77.3M
Net loss per common share - basic-$1.28-$1.32
Net loss per common share - diluted-$1.28-$1.32
Weighted average shares of common stock outstanding - basic62.1M shares58.4M shares
Weighted average shares of common stock outstanding - diluted62.1M shares58.4M shares
Net unrealized (loss) gain on marketable debt securities-$117.0K$107.0K
Other comprehensive (loss) income-$117.0K$107.0K
Comprehensive loss-$79.7M-$77.2M

Compare Pyxis Oncology, Inc. with another company

Corporate structure

Pyxis Oncology, 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 Pyxis Oncology, Inc.

  • Pyxis Oncology, Inc. Boston, Massachusetts

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

What it owns

What Pyxis Oncology, 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$15.0M4 Dec 31, 2025$15.1M4 Dec 31, 2024−0.8%
Accumulated depreciation$7.0M4 Dec 31, 2025$5.2M4 Dec 31, 2024+33.9%
Property and equipment, net$8.0M4 Dec 31, 2025$9.9M4 Dec 31, 2024−19.2%
Operating-lease assets (leased space)$11.4M4 Dec 31, 2025$12.2M4 Dec 31, 2024−6.7%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$15.4M4 Dec 31, 2025$19.5M4 Dec 31, 2024−20.8%
Marketable securities, current$51.4M4 Dec 31, 2025$107.5M4 Dec 31, 2024−52.1%

Intangibles and goodwill

ItemLatestA year beforeChange
Intangible assets, net (excluding goodwill)$04 Dec 31, 2025$2.6M4 Dec 31, 2024−100.0%
Accumulated amortization$514.0K4 Dec 31, 2025$302.0K4 Dec 31, 2024+70.2%
Finite-lived intangibles, net$2.6M8 Dec 31, 2024$3.3M7 Dec 31, 2023−22.2%

Properties, in its own words

Our headquarters are located at 321 Harrison Avenue, Boston, MA 02118, where we lease approximately 31,659 rentable square feet of office and laboratory space under a lease that terminates on December 31, 2032, with an additional five-year option to extend the lease beyond December 31, 2032. We also entered into a sublease for 17,729 square feet of this office and laboratory space commencing on March 24, 2023. The sublease agreement will continue through May 23, 2026. We continue to be responsible for performance under this lease until it expires on December 31, 2032.

We believe that our existing facilities are adequate to meet our current needs, and that suitable additional alternative spaces will be available in the future on commercially reasonable terms.

Item 2 of the 10-K filed Mar 23, 2026.3

Leadership

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

Board members and other officers (13)

Timeline

  1. Oct 1, 20268-K Entered a material agreement; Other events30
  2. Sep 9, 20268-K Regulation FD disclosure; Other events31
  3. Sep 8, 20268-K Executive or director change; Regulation FD disclosure32
  4. Aug 13, 20268-K Results of operations33
  5. Jul 2, 20268-K Entered a material agreement; Unregistered sale of shares; Regulation FD disclosure34
  6. Jun 15, 20268-K Shareholder vote35
  7. May 14, 20268-K Results of operations36
  8. Apr 30, 20268-K Executive or director change37
  9. Mar 23, 20268-K Results of operations; Regulation FD disclosure38
  10. Feb 6, 20268-K Financial statements and exhibits39
  11. Feb 5, 2026New chief executive Thomas Civik becomes CEO11
  12. Dec 18, 20258-K Regulation FD disclosure; Other events40
  13. Nov 3, 20258-K Results of operations41
  14. Oct 7, 2021New chief executive Lara Sullivan becomes CEO12

Calendar

Coming up

  1. Nov 2, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.35) a share, on Nov 3, 2025.42

When it reported results

  1. Aug 13, 2026Reported quarterly or annual results33
  2. May 14, 2026Reported quarterly or annual results36
  3. Mar 23, 2026Reported quarterly or annual results38
  4. Nov 3, 2025Reported quarterly or annual results41
  5. Aug 14, 2025Reported quarterly or annual results43
  6. May 15, 2025Reported quarterly or annual results44
  7. Mar 18, 2025Reported quarterly or annual results45
  8. Nov 12, 2024Reported quarterly or annual results46

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, 58 major events, 125 insider forms, 41 large holders, 95 other. The latest 20:

  1. Oct 9, 2026PRE 14A EDGAR
  2. Oct 9, 2026SCHEDULE 13G/A EDGAR
  3. Oct 9, 20264/A EDGAR
  4. Oct 5, 2026SCHEDULE 13G EDGAR
  5. Oct 2, 20264 EDGAR
  6. Oct 2, 2026SCHEDULE 13G/A EDGAR
  7. Oct 1, 20268-K EDGAR
  8. Oct 1, 2026424B5 EDGAR
  9. Sep 29, 2026424B5 EDGAR
  10. Sep 29, 2026424B5 EDGAR
  11. Sep 9, 20268-K EDGAR
  12. Sep 8, 20264 EDGAR
  13. Sep 8, 20268-K EDGAR
  14. Aug 28, 2026424B2 EDGAR
  15. Aug 27, 2026EFFECT EDGAR
  16. Aug 20, 20264 EDGAR
  17. Aug 20, 2026S-3 EDGAR
  18. Aug 14, 20264 EDGAR
  19. Aug 13, 202610-Q EDGAR
  20. Aug 13, 20268-K 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

24 open-market trades by officers, directors and large owners since October 2021: 14 buys and 10 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jun 30, 2026Dupont JakobDirectorSale35,000$3.06$107.1KForm 4
Apr 21, 2025HUMPHREY RACHELDirectorSale13,896$1.03$14.3KForm 4
Apr 17, 2025HUMPHREY RACHELDirectorSale200$0.97$194Form 4
Apr 14, 2025HUMPHREY RACHELDirectorSale1,400$0.97$1.4KForm 4
Nov 26, 2024Connealy Pamela AnnCFO & COOBuy88,850$1.96$174.4KForm 4
Sep 28, 2023Connealy Pamela AnnCFO & COOBuy8,000$1.87$15.0KForm 4
Sep 27, 2023Wadhane JitendraPrin Fin & Acct OfficerBuy2,500$1.87$4.7KForm 4
Sep 27, 2023Connealy Pamela AnnCFO & COOBuy6,426$1.85$11.9KForm 4
Sep 25, 2023Wadhane JitendraPrin Fin & Acct OfficerBuy5,000$1.77$8.8KForm 4
Sep 25, 2023Connealy Pamela AnnCFO & COOBuy12,000$1.67$20.0KForm 4
Sep 22, 2023Wadhane JitendraPrin Fin & Acct OfficerBuy2,500$1.74$4.3KForm 4
Sep 22, 2023Connealy Pamela AnnCFO & COOBuy5,000$1.74$8.7KForm 4
Sep 18, 2023Sullivan LaraPresident ,CEO & CMOSale8,541$2.10$17.9KForm 4
Sep 14, 2023Sullivan LaraPresident ,CEO & CMOSale100$2.25$225Form 4
Sep 13, 2023Sullivan LaraPresident ,CEO & CMOSale3,000$2.27$6.8KForm 4
Sep 12, 2023Sullivan LaraPresident ,CEO & CMOSale4,917$2.25$11.1KForm 4
Sep 11, 2023Sullivan LaraPresident ,CEO & CMOSale20,000$2.27$45.4KForm 4
Mar 17, 2023PFIZER INC10% ownerBuy1,811,594$2.76$5.0MForm 4
Mar 17, 2023PFIZER INC10% ownerBuy1,811,594$2.76$5.0MForm 4
Apr 21, 2022Chin MarkSale1,745,761$3.05$5.3MForm 4

All 24 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
2025Lara SullivanM.D.$646.9K$1.7M62
2025Pamela Connealy$1.4M62
2025Jitendra Wadhane45$414.0K$766.8K62
2024Former PresidentChief Executive Officer and Chief Medical Officer$625.0K$7.1M62
2024Former Chief Financial Officer and Chief Operating Officer$504.0K$2.6M62

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 75. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
GordonMD Global Investments LP10,024,909$30.2M14.6%+5,903,039
Pfizer Inc7,032,770$19.5M11.4%No change
Laurion Capital Management LP4,900,888$14.8M1.1%−96,445
Vanguard Capital Management LLC2,075,997$6.2M0.0%+42,487
Atle Fund Management AB966,459$2.9M0.8%+769,423
BlackRock, Inc.867,934$2.6M0.0%+79,095
Palo Alto Investors LP864,277$2.6M0.4%−146,233
Marshall Wace, Llp830,544$2.5M0.0%+476,127
Renaissance Technologies LLC772,232$2.3M0.0%−116,448
Geode Capital Management, LLC591,849$1.8M0.0%−6,272
Woodline Partners LP523,999$1.6M0.0%New
683 Capital Management, LLC459,367$1.4M0.1%−436,896
Jacobs Levy Equity Management, Inc428,606$1.3M0.0%−32,391
Longaeva Partners L.P.353,582$1.1M0.0%−149,632
Decheng Capital LLC326,810$983.7K0.1%No change
Vanguard Fiduciary Trust Co302,986$912.0K0.0%+2,089
Jane Street Group, LLC290,090$873.2K0.0%−14,369
State Street Corp248,837$749.0K0.0%No change
Millennium Management LLC233,004$701.3K0.0%−164,621
UBS Group AG155,217$467.2K0.0%−98,907
Bank of New York Mellon Corp133,996$403.3K0.0%No change
Northern Trust Corp123,959$373.1K0.0%+22,011
NewEdge Wealth, LLC116,006$349.2K0.0%No change
XTX Topco Ltd110,939$333.9K0.0%−89,157
Two Sigma Investments, LP83,961$252.7K0.0%+10,661

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

SEC filer profile

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

  • Name on EDGARPyxis Oncology, Inc.1
  • CIK0001782223
  • Employer ID (EIN)83-11609103
  • Filer statusNon-accelerated filer 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 address321 Harrison Avenue, Boston, MA 021181
  • Phone(617) 221-90591
  • Shares outstanding83,408,050 as of Aug 12, 202610
  • Public float$64.4M as of Jun 30, 20253
  • AuditorErnst & Young LLP, Boston, Massachusetts PCAOB ID 42; no auditor attestation of internal control over financial reporting3
  • On EDGAR sinceJul 12, 20191
  • Filings352 in all: 4 (102), 8-K (56), 3 (21), 144 (19), 10-Q (15), SC 13G/A (11), 425 (9), S-8 (9)1
    All 45 form types

    SC 13G (9), SCHEDULE 13G/A (9), CORRESP (8), EFFECT (7), UPLOAD (7), DEF 14A (6), SCHEDULE 13G (6), 10-K (5), DEFA14A (5), S-3 (4), 424B5 (3), ARS (3), S-1/A (3), SC 13D/A (3), 4/A (2), 424B2 (2), 8-K/A (2), D (2), DRS/A (2), DRSLTR (2), PRE 14A (2), SCHEDULE 13D/A (2), SEC STAFF LETTER (2), 10-K/A (1), 144/A (1), 424B3 (1), 424B4 (1), 8-A12B (1), CERT (1), DRS (1), POS AM (1), S-1 (1), S-1MEF (1), S-4 (1), S-4/A (1), S-8 POS (1), SC 13D (1)

  • Latest filingsAnnual report (10-K) Mar 23, 2026
    Quarterly report (10-Q) Aug 13, 2026
    Proxy statement (DEF 14A) Apr 30, 2026
    Latest 8-K (8-K) Oct 1, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.001 per sharePYXSNasdaq Global Select Market

From the cover page of the 10-K filed Mar 23, 2026 (Section 12(b) of the Exchange Act).3

Risk factors and legal proceedings

The risks Pyxis Oncology, Inc. names in Item 1A of its 10-K filed Mar 23, 2026: 74 risks under these headings, as written.3

  • Risks Related to Our Financial Position and Need for Additional Capital
  • We are a clinical stage oncology company with a limited operating history and have incurred significant losses since our inception and anticipate that we will continue to incur losses over at least the next several years and may never achieve or maintain profitability.
  • We have substantial doubt about our ability to continue as a going concern and we will require substantial additional capital to finance our operations. If we are unable to raise such capital when needed, or on acceptable terms, we may not be able to continue as a going concern or we may be forced to delay, reduce or eliminate one or more of our research and product development programs or future commercialization efforts.
  • Adverse developments affecting the financial services industry, including events or concerns involving liquidity, defaults or non-performance by financial institutions or transactional counterparties, could adversely affect our business, financial condition or results of operations.
  • Risks Related to the Development of our Product Candidate
  • Clinical testing and product development is a lengthy and expensive process with an uncertain outcome. We may incur unexpected costs or experience delays in completing, or ultimately be unable to complete, the clinical testing and the development and commercialization of our product candidate.
  • We are heavily dependent on the success of our product candidate, MICVO, which is in the early stages of clinical development. If MICVO is not successful in clinical trials or does not receive regulatory approval or licensure or is not successfully commercialized, our business will be materially and adversely affected.
  • Evolving regulatory expectations for oncology drug development could require additional studies and delay or prevent approval of our product candidate.
  • Our product candidate may fail in development or suffer delays that materially and adversely affect its commercial viability. If we or our existing or future collaborators are unable to initiate and complete clinical development of, obtain regulatory approval or licensure for or commercialize our product candidate or experience significant delays in doing so, our business will be materially harmed.
  • We have no experience as a company completing a clinical trial or submitting a BLA or NDA and may be unable to successfully do so for MICVO.
  • We may not be able to submit INDs to commence additional clinical trials on the timelines we expect and, even if we are able to, the FDA may not permit us to proceed.
  • Our preclinical studies and clinical trials may fail to demonstrate adequately the safety, purity and potency of our product candidate, which would prevent or delay development, regulatory approval or licensure and commercialization.
The other 64 risks
  • Interim top-line 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 to the final data.
  • We are parties to and may in the future enter into additional agreements with third parties under which those parties have or will be granted a license to develop product candidates discovered using our APXiMAB Platform. If any such programs are not successful or if disputes arise related to such programs, we may not realize the full commercial benefits from such programs.
  • We may expend our resources to pursue a particular product candidate and fail to capitalize on product candidates that may be more profitable or for which there is a greater likelihood of success.
  • The market may not be receptive to MICVO because it is based on our novel therapeutic modality, and we may not generate any future revenue from the sale or licensing of this product candidate.
  • We are early in our development efforts. Our lead product candidate, MICVO, is in the early stages of clinical development. The results of preclinical studies and early stage clinical trials may not be predictive of future results in later studies or trials. Initial success in clinical trials may not be indicative of results obtained when these trials are completed or in later-stage clinical trials.
  • If we or our collaborators experience delays or difficulties in the enrollment of patients in our clinical trials, these clinical trials could be delayed or prevented.
  • Our product candidate may cause undesirable and unforeseen side effects or have other properties impacting safety that could halt its clinical development, delay or prevent its regulatory licensure, limit its commercial potential or result in significant negative consequences.
  • If we do not achieve our projected development goals in the timeframes we announce and expect, the commercialization of our products may be delayed and, as a result, our stock price may decline.
  • We may face significant competition from other oncology-focused biotechnology and pharmaceutical entities, and our operating results will suffer if we fail to compete effectively.
  • Our business entails a significant risk of product liability, and if we are unable to obtain sufficient insurance coverage, such failure could have a material and adverse effect on our business, financial condition, results of operations and prospects.
  • Risks Related to Regulatory Licensure or Approval and Other Legal Compliance Matters
  • The regulatory licensure and approval processes of the FDA and other comparable foreign regulatory authorities are lengthy, time-consuming and inherently unpredictable and, if we are unable to obtain marketing licensure or approval for our product candidate, our business will be substantially harmed.
  • Even if we receive regulatory licensure of our 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 our product candidate.
  • If we decide to seek additional Breakthrough Therapy Designation and/or Fast Track Designation by the FDA, even if granted for any of our product candidate, may not lead to a faster development or regulatory review or licensure process and it does not increase the likelihood that our product candidate will receive marketing licensure.
  • If we decide to seek Orphan Drug Designation for any of our current or future product candidates, we may be unsuccessful or may be unable to maintain the benefits associated with Orphan Drug Designation, including the potential for supplemental market exclusivity.
  • If foreign regulatory authorities approve biosimilar versions of our product candidate that receive marketing approval, or such authorities do not grant our product candidate appropriate periods of data or market exclusivity before approving generic versions of our product candidate, the sales of our product candidate could be adversely affected.
  • Our failure to obtain regulatory approval in international jurisdictions would prevent us from marketing our product candidate outside the U.S. and the sales of our product candidate could be adversely affected.
  • The failure to obtain required regulatory clearances or approvals for any companion diagnostic tests that we may pursue may prevent or delay approval of our product candidate. Moreover, the commercial success of a product candidate that requires a companion diagnostic will be tied to the receipt of any required regulatory clearances or approvals and the continued availability of such tests.
  • Our relationships with customers, 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 these laws, we could face substantial penalties.
  • Even if we commercialize our product candidate, it or any other product candidate that we develop, may become subject to unfavorable pricing regulations or third party coverage or reimbursement practices, which could harm our business.
  • Enacted and future healthcare legislation may increase the difficulty and cost for us to progress our clinical programs and obtain marketing licensure or approval of and commercialize our product candidate and may affect the prices we may set.
  • Our operations are subject to trade controls, sanctions and anti-corruption laws, and noncompliance could result in significant penalties and operational disruption.
  • The biopharmaceutical industry is subject to extensive regulatory obligations and policies that may be subject to significant and abrupt change, including due to judicial challenges, election cycles, and resulting regulatory updates and changes in policy priorities.
  • Actual or perceived failures to comply with applicable data protection, privacy and security laws, regulations, standards and other requirements could adversely affect our business, operations, and financial condition.
  • If we or our third party manufacturers and suppliers 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 an adverse effect on the success of our business.
  • We are subject to U.S. and certain foreign export and import controls, anti-corruption laws and anti-money laundering laws and regulations. We can face criminal liability and other serious consequences for violations, which can harm our business.
  • Risks Related to Employee Matters, Managing Our Growth and Other Risks Related to Our Business
  • If we fail to attract and retain qualified senior management and key scientific and medical personnel, our business may be materially and adversely affected.
  • Our employees, consultants and collaborators may engage in misconduct or other improper activities, including insider trading and non-compliance with regulatory standards and requirements.
  • We currently have no marketing, sales, or distribution infrastructure and both establishing this infrastructure or outsourcing this function to a third party carries substantial risks to us.
  • Our information technology systems, or those of any of our existing or future CROs, manufacturers, other contractors, consultants, or collaborators, may be compromised, which could result in additional costs, significant liabilities, harm to our reputation and material disruption of our operations.
  • Our use of emerging technologies, including artificial intelligence, may introduce operational, legal and reputational risks.
  • Our research and development activities involve hazardous materials, and noncompliance with environmental, health and safety laws could result in significant liability.
  • Disruptions at the FDA, the SEC and other government agencies could hinder their ability to perform normal business functions on which the operation of our business may rely, which could negatively impact our business.
  • Risks Related to Our Dependence on Third Parties
  • If we fail to comply with our obligations under any license, collaboration or other agreements, we may be required to pay damages and could lose intellectual property rights that are necessary for developing and protecting our product candidate or we could lose certain rights to grant sublicenses.
  • We may form or seek additional collaborations or strategic alliances or enter into additional licensing arrangements in the future. If any of these collaborations, strategic alliances or licensing arrangements are not successful, we may not be able to capitalize on the market potential of the product candidate.
  • We rely on third parties to manufacture our product candidate. Any failure by a third party manufacturer to produce acceptable raw materials or product candidate for us or to obtain authorization from the FDA or comparable foreign regulatory authorities relating thereto may delay or impair our ability to initiate or complete our clinical trials, obtain regulatory licensure or approvals or commercialize approved products.
  • Legislative or regulatory restrictions on the use of certain foreign biotechnology or manufacturing service providers could materially disrupt our operations.
  • A portion of our manufacturing of our product candidate takes place in China, through third party manufacturers. A significant disruption in the operation of those manufacturers could materially adversely affect our business, financial condition and results of operations.
  • Our CDMOs may be unable to successfully scale-up manufacturing of our product candidate in sufficient quality and quantity, which would delay or prevent us from developing our product candidate and commercializing approved products, if any.
  • If we are unable to obtain sufficient raw and intermediate materials on a timely basis or if we experience other manufacturing or supply difficulties, our business may be adversely affected.
  • We expect to rely on third parties to conduct our clinical trials, and those third parties may not perform satisfactorily, including failing to meet deadlines for completing such trials.
  • Risks Related to Our Intellectual Property
  • If we are unable to obtain or protect our intellectual property in and to our product candidate, we may not be able to compete effectively in our markets.
  • Obtaining and maintaining our patent rights depends on compliance with various procedural, document submission, fee payment and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a negative impact on the success of our business.
  • We may be subject to claims asserting that our employees, consultants or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting ownership of what we regard as our own intellectual property.
  • Licensing of intellectual property is of critical importance to our business and involves complex legal, business and scientific issues. If we breach our Pfizer license agreement or any of the other agreements under which we acquired, or will acquire, intellectual property rights covering our product candidates, we could lose the ability to continue the development and commercialization of the related product candidates(s).
  • We may become involved in lawsuits to protect or enforce our patents, the patents of our licensors or our other intellectual property rights, which could be expensive, time-consuming and unsuccessful.
  • Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our current and any future product candidates.
  • We may not be able to protect our intellectual property rights throughout the world, which could negatively impact our business.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position may be harmed.
  • Reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.
  • Risks Related to Our Common Stock
  • Our stock price is volatile, and you could lose all or part of your investment.
  • The future issuance of equity or of debt securities that are convertible into equity will dilute our share capital.
  • If securities or industry analysts do not publish research or reports about our business, or if they issue adverse or misleading research or reports regarding us, our business or our market, our stock price and trading volume could decline.
  • Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and share price.
  • Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval and their interests may conflict with your interests as an owner of our common stock.
  • Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall.
  • We are an “emerging growth company” and a “smaller reporting company,” and the reduced disclosure requirements applicable to us may make our common stock less attractive to investors.
  • Anti-takeover provisions in our charter documents and under Delaware law would make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.
  • We have incurred and will continue to incur increased costs as a result of operating as a public company, and our management has and will be required to devote substantial time to new compliance initiatives and corporate governance practices. Additionally, 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 disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
  • Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, your ability to achieve a return on your investment will depend on appreciation of the value of our common stock.
  • We may be subject to securities litigation, which is expensive and could divert our management’s attention.
  • Our certificate of incorporation and bylaws designate the Court of Chancery of the State of Delaware as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.

Legal proceedings

From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. As of the date of this Annual Report on Form 10-K, we were not a party to any material legal matters or claims and we are not aware of any pending or threatened legal proceeding against us that we believe could have a material adverse effect on our business, operating results or financial condition.

The opening of Item 3, Legal Proceedings.3

Sources

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