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HCWB on Nasdaq

HCW Biologics Inc.

American pharmaceutical preparations company based in Miramar2

In its 2026 annual report the company says: “HCW Biologics Inc. is a clinical-stage biopharmaceutical company developing transformative fusion immunotherapeutics to support or treat diseases promoted by chronic inflammation.”4 Its shares trade on Nasdaq under the symbol HCWB.2

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Last updated Oct 21, 2026.

Overview

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  • TickerHCWB on Nasdaq2
  • IndustryPharmaceutical Preparations2
  • HeadquartersMiramar, United States2
  • Incorporated inDE3
  • Business address2929 N Commerce Pkwy, Miramar, Fl 330253
  • Filer category, Emerging growth company3
  • Legal formCorporation2
  • LEI5299008ZJ4RXXTN04Z972
  • StatusActive2
  • LEI statusIssued and current2
  • Registered addressc/o Corporation Service Company, 251 Little Falls Drive, 19808 Wilmington, United States2
  • Registered withDivision of Corporations, Department of State, 68266802

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HCW Biologics Inc. (“HCW Biologics” or the “Company”) is a clinical-stage biopharmaceutical company developing transformative fusion immunotherapeutics to support or treat diseases promoted by chronic inflammation. We have created novel compounds that represent a new class of drugs that we believe have the potential to fundamentally change the treatment of autoimmune disorders and other proinflammatory diseases, cancer and senescence-associated dysplasia. Among other things, we have begun commercialization of certain commercial-ready proprietary compounds for use as reagents in the production of immunotherapeutics for the treatment of infectious diseases and cancer. We want our products to improve patients’ healthspan as well as their quality of life, and possibly extend longevity.4 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

20.0%Gross margin5
-24270.7%Operating margin5
-14677.1%Net margin5
-97.9%Revenue growth, 20255
-287.9%Return on equity5
0.00×Debt to equity5
-$13.4MFree cash flow5

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue1¢$43.4K
  • Research and development86¢$5.4M
  • Interest13¢$845.1K

Out of $54.2K in revenue.5 The company lost money this year.

Financial statements

Revenue67895$54.2K in 2025−99% since 2020
0$2.0M$4.0M$6.0M$8.0M2020: $4.1M$4.1M20202021: $0$020212022: $6.7M$6.7M20222023: $2.8M$2.8M2023−58%2024: $2.6M$2.6M2024−10%2025: $54.2K$54.2K2025−98%
Gross profit7895$10.8K in 2025
0$1.0M$2.0M$3.0M2021: $0$020212022: $2.6M$2.6M20222023: $560.4K$560.4K2023−78%2024: $959.4K$959.4K2024+71%2025: $10.8K$10.8K2025−99%
Operating income67895-$13.2M in 2025+126% since 2020
-$30.0M-$20.0M-$10.0M02020: -$5.8M-$5.8M20202021: -$13.4M-$13.4M2021+130%2022: -$15.1M-$15.1M2022+13%2023: -$25.7M-$25.7M2023+71%2024: -$29.5M-$29.5M2024+15%2025: -$13.2M-$13.2M2025−55%
Net income67895-$8.0M in 2025+37% since 2020
-$40.0M-$30.0M-$20.0M-$10.0M02020: -$5.8M-$5.8M20202021: -$12.9M-$12.9M2021+122%2022: -$14.9M-$14.9M2022+16%2023: -$25.0M-$25.0M2023+68%2024: -$30.0M-$30.0M2024+20%2025: -$8.0M-$8.0M2025−73%

Every line of the income statement as filed: the last 2 fiscal years, latest first.5

Period ending2025-12-312024-12-31
Revenues$54.2K$2.6M
Cost of revenues-$43.4K-$1.6M
Net revenues$10.8K$959.4K
Research and development$5.4M$6.4M
General and administrative$7.7M$6.8M
Legal expenses (recoveries), net-$1.5M$15.9M
Impairment of Long-Lived Asset$1.5M$0
Nonoperating loss$0$1.3M
Total operating expenses$13.2M$30.4M
Loss from operations-$13.2M-$29.5M
Interest expense-$845.1K-$654.3K
Change in fair value of investment-$273.4K$0
Change in fair value of contingent liability$1.1M$0
Loss on sale of put shares-$264.0K$0
Gain on extinguishment of liability$5.5M$0
Other income, net$68.4K$87.0K
Net loss-$8.0M-$30.0M
Equity dividend to investor-$14.3M$0
Net loss attributable to Common Stockholders-$22.3M-$30.0M
Net loss per share, basic-$10.63-$30.96
Net loss per share, diluted-$10.63-$30.96
Weighted-average shares outstanding, basic2.1M shares969.8K shares
Weighted-average shares outstanding, diluted2.1M shares969.8K shares

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Corporate structure

HCW Biologics 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 HCW Biologics Inc.

  • ARMISTICE CAPITAL, LLC Filed SCHEDULE 13G/A on HCW Biologics Inc., latest May 15, 2026 (2 filings since Feb 17, 2026)
  • Hing C. Wong Filed SCHEDULE 13D/A on HCW Biologics Inc., latest Jun 13, 2025 (2 filings since Nov 22, 2024)
  • HCW Biologics Inc. Miramar, Florida, United States

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What HCW Biologics 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$25.1M5 Dec 31, 2025$26.6M5 Dec 31, 2024−5.7%
Accumulated depreciation$4.2M5 Dec 31, 2025$3.7M5 Dec 31, 2024+13.8%
Property and equipment, net$20.9M5 Dec 31, 2025$22.9M5 Dec 31, 2024−8.9%

Real estate and locations

ItemLatestA year beforeChange
Area of land12,250 sq ft5 Dec 31, 202512,250 sq ft9 Dec 31, 20240%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$2.0M5 Dec 31, 2025$4.7M5 Dec 31, 2024−58.2%
Marketable securities, current$05 Dec 31, 2025$05 Dec 31, 2024
Long-term investments$1.3M5 Dec 31, 2025$1.6M5 Dec 31, 2024−17.1%

Properties, in its own words

On August 15, 2022, we purchased a 36,000 square foot building located in Miramar, Florida, as our new headquarters. We intend to use the new facility for research and development laboratories and facilities for manufacturing, as well as offices for our employees, including clinical development, research, development, quality control, quality assurance, regulatory affairs, and administration. We have been in the process of refitting the building for our purposes. The property is under construction, and it is uncertain when the project will be completed. Until such time as the project is completed, we continue to occupy approximately 12,250 square feet of space in Miramar, Florida and currently lease this space under the terms of a lease that commenced on March 1, 2026 and terminates on February 28, 2027. Given our long relationship with the landlord of our leased location, we believe we will be able to negotiate an extension our lease, if required. We believe our existing location is sufficient to meet our current and near-term needs.

Item 2 of the 10-K filed Mar 31, 2026.4

Leadership

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

Chief financial officer

  1. Rebecca Byam2021–now
2025
Board members and other officers (6)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive Officer, DirectorHing C. Wong named Feb 27, 2024 to Aug 6, 202619
  • Executive OfficerLee S. Flower named Jun 8, 202620
  • DirectorRick S. Greene named Feb 27, 2024 to Aug 6, 202619

Timeline

  1. Sep 24, 20268-K Entered a material agreement; Unregistered sale of shares; Regulation FD disclosure21
  2. Sep 10, 20268-K Regulation FD disclosure; Other events22
  3. Sep 8, 20268-K Entered a material agreement; Regulation FD disclosure23
  4. Aug 14, 20268-K Earlier financial statements no longer reliable24
  5. Aug 14, 20268-K Results of operations25
  6. Jul 29, 20268-K Entered a material agreement; Unregistered sale of shares; Regulation FD disclosure26
  7. Jul 1, 20268-K Other events27
  8. Jun 30, 20268-K Listing notice or transfer28
  9. Jun 26, 20268-K Change to shareholders' rights; Bylaws or fiscal year changed; Regulation FD disclosure29
  10. Jun 16, 20268-K Regulation FD disclosure30
  11. Jun 15, 20268-K Shareholder vote31
  12. Jun 1, 20268-K Listing notice or transfer32
  13. Apr 2, 2018Founded HCW Biologics Inc. is founded2

Calendar

Coming up

  1. Nov 13, 2026Reports results for the quarter ending Sep/202633

When it reported results

  1. Aug 14, 2026Reported quarterly or annual results25
  2. May 14, 2026Reported quarterly or annual results34
  3. Mar 31, 2026Reported quarterly or annual results35
  4. Nov 14, 2025Reported quarterly or annual results36
  5. Aug 18, 2025Reported quarterly or annual results37
  6. Aug 14, 2025Reported quarterly or annual results38
  7. May 15, 2025Reported quarterly or annual results39
  8. Mar 28, 2025Reported quarterly or annual results40

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

Filings

277 filings to the SEC since October 2021: 6 annual reports, 17 quarterly reports, 96 major events, 80 insider forms, 4 large holders, 5 private raises, 69 other. The latest 20:

  1. Oct 9, 2026EFFECT EDGAR
  2. Oct 8, 2026D EDGAR
  3. Oct 2, 2026S-1 EDGAR
  4. Oct 1, 2026DEF 14A EDGAR
  5. Sep 24, 20268-K EDGAR
  6. Sep 10, 20268-K EDGAR
  7. Sep 9, 2026PRER14A EDGAR
  8. Sep 8, 20268-K EDGAR
  9. Sep 8, 2026PRE 14A EDGAR
  10. Aug 31, 2026EFFECT EDGAR
  11. Aug 28, 2026S-1/A EDGAR
  12. Aug 20, 2026S-1 EDGAR
  13. Aug 14, 202610-Q EDGAR
  14. Aug 14, 20268-K EDGAR
  15. Aug 14, 202610-Q/A EDGAR
  16. Aug 14, 20268-K EDGAR
  17. Aug 6, 2026D EDGAR
  18. Jul 31, 20264 EDGAR
  19. Jul 31, 20264 EDGAR
  20. Jul 31, 20264 EDGAR

The 277 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

71 open-market trades by officers, directors and large owners since October 2021: 71 buys and 0 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jul 29, 2026Wong Hing CChief Executive OfficerBuy23,210$2.59$60.1KForm 4
Jul 29, 2026Flowers LeeSVP of Business DevelopmentBuy7,736$2.59$20.0KForm 4
Jul 29, 2026GARRETT SCOTT TDirectorBuy7,736$2.59$20.0KForm 4
May 22, 2026Wong Hing CChief Executive OfficerBuy113,879$1.41$160.6KForm 4
May 22, 2026GARRETT SCOTT TDirectorBuy177,936$1.41$250.9KForm 4
May 22, 2026Byam RebeccaChief Financial OfficerBuy14,235$1.41$20.1KForm 4
May 16, 2025Wong Hing CChief Executive OfficerBuy8,054$7.45$60.0KForm 4
May 16, 2025Winer Gary MDirectorBuy1,342$7.45$10.0KForm 4
May 16, 2025GARRETT SCOTT TDirectorBuy13,423$7.45$100.0KForm 4
May 8, 2025Winer Gary MDirectorBuy2,308$26.00$60.0KForm 4
May 8, 2025Wong Hing CChief Executive OfficerBuy92,500$26.00$2.4MForm 4
May 8, 2025GARRETT SCOTT TDirectorBuy5,385$26.00$140.0KForm 4
May 8, 2025Byam RebeccaChief Financial OfficerBuy8,462$26.00$220.0KForm 4
May 8, 2025Flowers LeeSVP of Business DevelopmentBuy962$26.00$25.0KForm 4
May 8, 2025Greene Rick S.DirectorBuy962$26.00$25.0KForm 4
Sep 14, 2023Wong Hing CChief Executive OfficerBuy1,800$2.08$3.7KForm 4
Sep 14, 2023Winer Gary MDirectorBuy1,041$2.05$2.1KForm 4
Sep 13, 2023Winer Gary MDirectorBuy546$2.05$1.1KForm 4
Sep 13, 2023Byam RebeccaChief Financial OfficerBuy5,000$2.10$10.5KForm 4
Sep 12, 2023Byam RebeccaChief Financial OfficerBuy5,000$2.09$10.4KForm 4

All 71 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.

  • ARMISTICE CAPITAL, LLCSCHEDULE 13G/A, 2 filings Feb 17, 2026 to May 15, 202641
  • Hing C. WongSCHEDULE 13D/A, 2 filings Nov 22, 2024 to Jun 13, 202542

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$15.6M 2020–2026
Money received by yearMoney received by year, 2020–2026: $15.6M in all. Private raises (Form D) $15.0M; PPP loans $563.6K.$0$2.5M$5M$7.5M$10M2020 · PPP loans: $563.6K202020222024 · Private raises (Form D): $9.4M20242026 · Private raises (Form D): $5.6M2026
Figures by year
YearPrivate raises (Form D)PPP loansTotal
2026$5.6M–$5.6M
2024$9.4M–$9.4M
2020–$563.6K$563.6K

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. Jul 29, 2026Raised $1.6 million in a private offering of equity19 Form D: 4 investors so far Form D
  2. May 21, 2026Raised $4 million in a private offering of equity20 Form D: 7 investors so far Form D
  3. Nov 20, 2024Raised $6.9 million in a private offering of securities43 Form D: 1 investor so far Form D
  4. Feb 20, 2024Raised $2.5 million in a private offering of equity44 Form D: 6 investors so far Form D

PPP loans

Paycheck Protection Program loans of $150,000 and up, approved April 2020 to July 2021, from the SBA45. Matched to this company by name and state.

  1. Apr 27, 2020$563.6K PPP loan (first draw) from Cogent Bank45To HCW BIOLOGICS, INC, Mirmar FL; $567.1K forgiven Dec 17, 2020

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
Jane Street Group, LLC52,138$260.2K0.0%New
Citadel Advisors LLC19,942$99.5K0.0%New
Vanguard Fiduciary Trust Co6,510$32.5K0.0%New
Tower Research Capital LLC (TRC)4,117$20.5K0.0%New
Connective Capital Management, LLC3,338$16.7K0.0%New
Vanguard Capital Management LLC2,003$10.0K0.0%New
Golden State Wealth Management, LLC1,667$8.3K0.0%New
Barclays PLC191$9530.0%New
Hrt Financial LP13,583$670.0%New
Osaic Holdings, Inc.4$200.0%New
Caitong International Asset Management Co., Ltd11$100.0%New
UBS Group AG1$50.0%New

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

SEC filer profile

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

  • Name on EDGARHCW Biologics Inc.1
  • CIK0001828673
  • Employer ID (EIN)82-50244774
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company4
  • Incorporated inDelaware4
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address2929 N Commerce Pkwy, Miramar, FL 330251
  • Phone954-842-20241
  • Shares outstanding1,836,324 as of Aug 14, 202610
  • Public float$6.2M as of Jun 30, 20254
  • AuditorCrowe LLP, Indianapolis, Indiana PCAOB ID 173; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceOct 19, 20201
  • Filings336 in all: 8-K (96), 4 (94), 10-Q (16), CORRESP (15), 3 (10), EFFECT (10), S-1 (9), S-1/A (9)1
    All 41 form types

    DEF 14A (8), D (6), 10-K (5), 4/A (5), DRS (5), UPLOAD (5), ARS (4), PRE 14A (4), 424B4 (3), DEFA14A (3), POS AM (3), 10-Q/A (2), 8-K/A (2), FWP (2), SEC STAFF LETTER (2), 10-K/A (1), 424B2 (1), 424B3 (1), 8-A12B (1), ARS/A (1), CERT (1), CT ORDER (1), DEFR14A (1), NT 10-Q (1), PRER14A (1), S-1MEF (1), S-3 (1), S-8 (1), SC 13D (1), SC 13D/A (1), SCHEDULE 13D/A (1), SCHEDULE 13G (1), SCHEDULE 13G/A (1)

  • Latest filingsAnnual report (10-K) Mar 31, 2026
    Quarterly report (10-Q) Aug 14, 2026
    Proxy statement (DEF 14A) Oct 1, 2026
    Latest 8-K (8-K) Sep 24, 2026

Securities registered for trading

ClassSymbolExchange
Common StockHCWBThe Nasdaq Stock Market LLC

From the cover page of the 10-K filed Mar 31, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks HCW Biologics Inc. names in Item 1A of its 10-K filed Mar 31, 2026: 51 risks under these headings, as written.4

  • Risks Related to our Financial Position and Need for Additional Capital
  • We have incurred significant losses since our inception and we expect to incur losses for the foreseeable future. We have no products approved for commercial sale and may never achieve or maintain profitability.
  • There is substantial doubt about our ability to continue as a going concern. We will need to raise additional funding, which may not be available on acceptable terms, if at all to continue as a going concern and advance our product candidates. Failure to obtain capital when needed may force us to delay, limit or terminate our product development efforts or other operations. Raising additional capital may dilute our existing shareholders, restrict our operations or cause us to relinquish valuable rights.
  • Our limited operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability.
  • We cannot assure you that the measures we have taken to date to strengthen internal controls over financial reporting, or any measures we may take in the future, will be sufficient to avoid potential future material weaknesses.
  • We will require additional funding in order to complete development of our product candidates and commercialize our products, if approved. However, this additional financing may not be available on acceptable terms, or at all. If we are unable to raise capital when needed, we could be forced to delay, reduce, or eliminate our product development programs or commercialization efforts.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
  • There can be no assurance that we will be able to comply with the continued listing standards of Nasdaq, a failure of which could result in a delisting of our securities.
  • The Company’s balance sheet has liabilities that will require payment, and use of funds for this purpose will make less funding available for operations and clinical development.
  • Risks Related to our Business
  • If we or any collaborators we work with in the future are unable to successfully develop and commercialize our product candidates, or experience significant delays in doing so, our business, financial condition, and results of operations will be materially adversely affected.
  • A key element of our strategy is to enter into out-licensing arrangements for certain rights to internally-developed molecules that we do not intend to develop into lead product candidates on our own or together with co-development partners. We may not be able to identify licensees, which could lower any return on our investments and increase our need for external funding.
The other 41 risks
  • The success of our business development efforts, including license agreements, depends on our ability to realize and anticipate the benefits of these transactions and is subject to numerous risks and uncertainties, many of which are outside of our control.
  • We expect to continue to expand our capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
  • Our business and operations are subject to risks related to climate change.
  • Risks Related to the Development and Clinical Testing of Our Product Candidates
  • Our clinical trials may fail to demonstrate the safety and efficacy of our product candidates or any future product candidates, which would prevent or delay or limit the scope of regulatory approval and commercialization.
  • Preliminary, topline or interim data from our clinical trials that we announce or publish from time to time may change as more patient data becomes available and are subject to audit and verification procedures that could result in material changes in the final data.
  • Clinical drug development is a lengthy and expensive process with uncertain timelines and uncertain outcomes. If clinical trials of our product candidates are prolonged or delayed, we or any collaborators may be unable to obtain required regulatory approvals, and therefore be unable to commercialize our product candidates on a timely basis or at all.
  • We may become exposed to costly and damaging product 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.
  • Risks Related to Our Regulatory Environment
  • The development and commercialization of biopharmaceutical products is subject to extensive regulation, and the regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time-consuming, and inherently unpredictable. If we are ultimately unable to obtain regulatory approval for our product candidates on a timely basis, if at all, our business will be substantially harmed.
  • 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 it will receive marketing approval. If we are unable to obtain approval under an accelerated pathway, we may be required to conduct additional clinical trials beyond those that we contemplate, which could increase the expense of obtaining, reduce the likelihood of obtaining and/or delay the timing of obtaining, necessary marketing approvals.
  • There is substantial uncertainty regarding the new Administration’s initiatives and how these might impact the FDA, its implementation of laws, regulations, policies and guidance and its personnel. Similar initiatives may also be directed toward other government agencies. These initiatives could prevent, limit or delay development and regulatory approval, and/or impact commercialization, of our product candidates, which would impact our business.
  • Even if our product candidates obtain regulatory approval, we will be subject to ongoing obligations and continued regulatory review, which may result in significant additional expense. Additionally, our product candidates, if approved, could be subject to labeling and other restrictions and market withdrawal and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our products.
  • Our employees, independent contractors, principal investigators, consultants, commercial partners, and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • Our current and future relationships with customers and third-party payors may be subject to applicable anti-kickback, fraud and abuse, transparency, health privacy, and other healthcare laws and regulations, which could expose us to significant penalties, including criminal, civil, and administrative penalties, contractual damages, reputational harm and diminished profits and future earnings.
  • Current and future legislation may increase the difficulty and cost for us and any future collaborators to obtain marketing approval of and commercialize our product candidates and affect the prices we, or they, may obtain.
  • Risks Related to Commercialization of Our Product Candidates
  • We operate in highly competitive and rapidly changing industries, which may result in others discovering, developing or commercializing competing products before or more successfully than we do.
  • Failure to successfully identify, develop, and commercialize additional product candidates could impair our ability to grow.
  • Even if approved, our products may not gain market acceptance, in which case we may not be able to generate product revenues, which will materially adversely affect our business, financial condition, and results of operations.
  • We currently have no marketing, sales, or distribution infrastructure and we intend to either establish a sales and marketing infrastructure or outsource this function to a third party. Either of these commercialization strategies carries substantial risks to us.
  • Risks Related to Our Dependence on Third Parties
  • We rely on third parties to manufacture our product candidates. Any failure by a third-party manufacturer to produce acceptable drug substance for us or to obtain authorization from the FDA or comparable regulatory authorities may delay or impair our ability to initiate or complete our clinical trials, obtain regulatory approvals or commercialize approved products.
  • Supply sources could be interrupted from time to time and, if interrupted, there is no guarantee that supplies could be resumed within a reasonable time frame and at an acceptable cost or at all.
  • We currently rely on, and expect to continue to rely on, third parties, including independent clinical investigators, to conduct our preclinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties, comply with applicable regulatory requirements, 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.
  • We may not realize the benefits of any existing or future co-development or out-licensing arrangement, and if we fail to enter into new strategic relationships, our business, financial condition, commercialization prospects, and results of operations may be materially adversely affected.
  • To date, we have relied on one third-party manufacturer for the cGMP production of our drug product candidates. The loss of this third-party manufacturer could negatively impact our ability to develop our product candidates and adversely affect our business.
  • Risks Related to Intellectual Property
  • We expect to rely on patents and other intellectual property rights to protect our technology, including product candidates and our immunotherapy platform technology, the prosecution, enforcement, defense, and maintenance of which may be challenging and costly. Failure to protect or enforce these rights adequately could harm our ability to compete and impair our business.
  • We may become involved in lawsuits to protect or enforce our issued patents relating to one or more of our product candidates or our internally-developed platform, which could ultimately render our patents invalid or unenforceable and adversely affect our competitive position. Intellectual property litigation or other legal proceedings could cause us to spend substantial resources and distract our personnel from their normal responsibilities.
  • Intellectual property rights of third parties could adversely affect our ability to develop or commercialize our product candidates, such that we could be required to litigate or obtain licenses from third parties in order to develop or market our product candidates.
  • We may need to obtain licenses of third-party technology that may not be available to us or are available only on commercially unreasonable terms, and which may cause us to operate our business in a more costly or otherwise adverse manner that was not anticipated.
  • We are and may become subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
  • We may rely on trade secret and proprietary know-how, which can be difficult to trace and enforce and, if we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • We may be in the future subject to third-party claims asserting that our employees, consultants, contractors, collaborators, or advisors have misappropriated or wrongfully used or disseminated their intellectual property, or claiming ownership of what we regard as our own intellectual property.
  • Risks Related to Data Privacy and Cybersecurity
  • Our information technology systems, or those used by our third-party contractors or consultants, may fail or suffer security breaches, which could adversely affect our business.
  • Our potential use of new and evolving technologies, such as artificial intelligence, may present risks and challenges that can impact our business, including by posing cybersecurity and other risks to our confidential and/or proprietary information, including personal information, and as a result we may be exposed to reputational harm and liability.
  • Risks Related to Ownership of Our Common Stock
  • Our stock price may be volatile or may decline regardless of our operating performance, resulting in substantial losses for investors.
  • 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.
  • We are an emerging growth company as well as a “smaller reporting company”, and any decision on our part to comply only with certain reduced reporting and disclosure requirements applicable to emerging growth companies or smaller reporting companies could make our Common Stock less attractive to investors.
  • If we fail to maintain proper and effective internal controls over financial reporting, our ability to produce accurate and timely financial statements could be impaired.
  • Provisions in our amended and restated certificate of incorporation and our amended and restated bylaws and Delaware law might discourage, delay or prevent a change in control of our company or changes in our management and, therefore, depress the market price of our Common Stock.
  • Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
  • General Risk Factors
  • Unfavorable global economic conditions could adversely affect our business, financial condition, stock price and results of operations.
  • Our money market or other investments or bank deposits may be subject to market, interest and credit risk that may reduce in value.
  • Our future growth and ability to compete depends on retaining our key personnel and recruiting additional qualified personnel.

Legal proceedings

From time to time, the Company is a party to or otherwise involved in legal proceedings, including suits, assessments, regulatory actions and investigations generally arising out of the normal course of business. Such proceedings can be costly, time consuming, and unpredictable. Therefore, no assurance can be given on the outcome of any proceeding or the potential impact on our results of operations or financial condition.

Settlement and General Release: Arbitration

During the year ended December 31, 2022, Altor/NantCell initiated legal proceedings against Dr. Wong and the Company. On April 26, 2023, the parties stipulated that Altor/NantCell’s action against the Company would be consolidated with the Altor/NantCell Arbitration demand against Dr. Wong. On April 27, 2023, the U.S. District Court for the Southern District of Florida (the “Court”) with jurisdiction over the lawsuit against the Company approved the parties’ stipulation and ordered the parties to Arbitration. On May 1, 2023, Altor/NantCell filed a demand against the Company before JAMS. On May 3, 2023, Altor/NantCell dismissed the federal court action without prejudice and the Court ordered the case dismissed without prejudice and closed the case. Proceedings against the Company and Dr. Wong were consolidated in the Arbitration before JAMS. The Arbitration hearing was held from May 20, 2024 to May 31, 2024, after which the parties entered into settlement negotiations.

The opening of Item 3, Legal Proceedings.4

Sources

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