SABS on Nasdaq

SAB Biotherapeutics, Inc.

In its 2026 annual report the company says: “We are a clinical-stage biopharmaceutical company focused on developing multi-specific, high-potency, human immunoglobulin G (hIgG) to treat and prevent immune and autoimmune disorders. Our programs are based on mechanisms of action that have achieved proof-of-concept in clinical trials in indications with significant unmet medical needs.”3 It is headquartered in Miami Beach, Florida.1 Its shares trade on Nasdaq under the symbol SABS.1

Price unavailable

Last updated Oct 21, 2026.

Overview

Compare with Scinai Immunotherapeutics Ltd., Inhibrx Biosciences, Inc. or Cidara Therapeutics, or pick any stock.

  • TickerSABS on Nasdaq1
  • IndustryBiological Products, (No Diagnostic Substances)1
  • HeadquartersMiami Beach, Florida1
  • Incorporated inDE2
  • Business address777 W 41St St, Suite 401, Miami Beach, Fl 331402
  • Filer category, Emerging growth company2
  • Legal formCorporation

We are a clinical-stage biopharmaceutical company focused on developing multi-specific, high-potency, human immunoglobulin G (hIgG) to treat and prevent immune and autoimmune disorders. Our programs are based on mechanisms of action that have achieved proof-of-concept in clinical trials in indications with significant unmet medical needs. We are focused on developing product candidates for disease targets where a differentiated approach has the greatest potential to be either first-in-class against novel targets or best-in-class against complex targets to treat diseases, including type 1 diabetes (T1D) and other autoimmune disorders. The Company’s lead candidate, SAB-142, targets autoimmune T1D with a disease-modifying therapeutic approach that aims to potentially change the T1D treatment paradigm by delaying onset and potentially preventing disease progression of Stage 3 T1D patients.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

-100.0%Revenue growth, 20254
8.8%Return on equity4
-$45.7MFree cash flow4

Financial statements

Revenue5674$0 in 2025
0$20.0M$40.0M$60.0M$80.0M2020: $55.2M$55.2M20202021: $60.9M$60.9M2021+10%2022: $23.9M$23.9M2022−61%2023: $2.2M$2.2M2023−91%2024: $1.3M$1.3M2024−41%2025: $0$02025
Operating income5674-$49.0M in 2025
-$60.0M-$40.0M-$20.0M0$20.0M$40.0M2020: $20.6M$20.6M20202021: -$13.4M-$13.4M20212022: -$28.9M-$28.9M2022+116%2023: -$38.1M-$38.1M2023+32%2024: -$42.9M-$42.9M2024+13%2025: -$49.0M-$49.0M2025+14%
Net income5674$13.3M in 2025−34% since 2020
-$60.0M-$40.0M-$20.0M0$20.0M$40.0M2020: $20.1M$20.1M20202021: -$17.1M-$17.1M20212022: -$18.7M-$18.7M2022+9%2023: -$42.2M-$42.2M2023+125%2024: -$34.1M-$34.1M2024−19%2025: $13.3M$13.3M2025

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

Period ending2025-12-312024-12-31
Total revenue$0$1.3M
Research and development$34.4M$30.3M
General and administrative$14.6M$14.0M
Total operating expenses$49.0M$44.2M
Loss from operations-$49.0M-$42.9M
Changes in fair value of warrant liabilities$62.8M$5.4M
Interest expense-$240.7K-$318.4K
Interest income$1.4M$1.3M
Other income$3.1M$2.5M
Warrant issuance expense-$4.9M$0
Total other income$62.2M$8.8M
Net income (loss)$13.3M-$34.1M
Unrealized gain, change in fair value of available-for-sale securities, net of tax$185.5K$647
Foreign currency translation gain (loss)$136.5K-$162.5K
Total comprehensive income (loss)$13.6M-$34.3M
Basic income (loss) per common share$0.22-$3.68
Diluted loss per common share-$0.79-$3.68
Weighted-average common shares outstanding - basic19.3M shares9.3M shares
Weighted-average common shares outstanding - diluted61.3M shares9.3M shares

Compare SAB Biotherapeutics, Inc. with another company

Corporate structure

SAB Biotherapeutics, 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 SAB Biotherapeutics, Inc.

  • SAB Biotherapeutics, Inc. Miami Beach, Florida

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

What it owns

What SAB Biotherapeutics, 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$30.8M4 Dec 31, 2025$29.9M4 Dec 31, 2024+2.9%
Accumulated depreciation$17.5M4 Dec 31, 2025$14.6M4 Dec 31, 2024+20.2%
Property and equipment, net$13.3M4 Dec 31, 2025$15.4M4 Dec 31, 2024−13.4%
Finance-lease assets$3.5M4 Dec 31, 2025$3.6M4 Dec 31, 2024−2.4%
Operating-lease assets (leased space)$2.6M4 Dec 31, 2025$970.3K4 Dec 31, 2024+168.3%

Real estate and locations

ItemLatestA year beforeChange
Area of real estate3,099 sq ft4 Sep 30, 2025

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$10.5M4 Dec 31, 2025$8.9M4 Dec 31, 2024+18.0%
Marketable securities, current$86.1M4 Dec 31, 2025$11.9M4 Dec 31, 2024+625.7%
Debt securities available for sale$73.9M4 Dec 31, 2025
Equity securities at fair value$59.1M4 Dec 31, 2025$5.6M4 Dec 31, 2024+955.4%
Long-term investments$46.9M4 Dec 31, 2025

Properties, in its own words

Research Center

As of December 31, 2025, our facilities include current Good Manufacturing Practice (cGMP) operations where drug products are manufactured in the clinical manufacturing facility located within the 60,000 square foot laboratory bay at the Sanford Research Center (the “Research Center”) in Sioux Falls, South Dakota encompassing a 17,300 square foot manufacturing area that includes the clinical manufacturing facility, -20°C plasma storage, and a controlled warehouse.

The rest of Item 2

The Research Center lease is currently set to expire in December 2029.

Research and Development Campus

The Company leases its research and development campus at 2100 East 54th Street North, Sioux Falls, SD 57104 (the “Research and Development Campus”). The lease covers approximately 49,600 square feet of office and laboratory space, with approximately 18,400 square feet of space dedicated to research and development activities.

The Research and Development Campus lease is set to expire in October 2026 with a Company option to extend for an additional three-year term with a final expiration of October 2029.

TC Cattle Facility

Transchromosomic (Tc) cattle used for hyperimmunization, and plasma collection are housed at our animal facilities which we refer to as the “Pharm”. The Pharm is a biosecure site dedicated to housing and rearing these animals. The physical surroundings are maintained in accordance with various governmental regulations. This site also includes surgical suite and plasma collection areas. Facilities are appropriate for cattle housing and give adequate protection from inclement weather conditions. Double barrier fencing (perimeter fencing and locked exterior gating) is designed to prevent Tc cattle from escaping or other unwanted animals from entering. Production animal pens consist of concrete feeding floors, water fountains and outdoor dirt lots. A biosecurity program is critical to the production of human pharmaceuticals from animals. The production herd is considered “closed” from a biosecurity perspective and inputs (feed, nutritional additives, medications, etc.) and outputs to the system are carefully monitored according to the appropriate regulations. A pest control program is instituted to control vermin. The biosecurity program is managed using a combination of procedural controls, facility design features (such as barriers, fencing and housing), controlled access and employee training into or out of the site. Tc Bovine plasma is collected from the animals in designated areas at the Pharm. The areas are cleaned and maintained per the rules and regulations of the FDA. The Fenwal Auto-C plasmapheresis machine (human device) is used to collect plasma. Plasma is collected aseptically under standard sanitary conditions using a closed system and sterile bags to avoid microbial contamination. Following plasmapheresis, the plasma bioprocessing bags are labeled and shipped to the Company’s manufacturing facility or to contract manufacturers.

The Pharm real property lease in Canton, South Dakota is currently set to expire in November 2038.

Corporate Headquarters

The Company leases its corporate headquarters located at 777 W 41st Suite 401, Miami Beach, FL (the “Corporate Headquarters”). The lease covers approximately 1,272 square feet of office space. In September 2025, the Company signed a new lease expanding the leased space of 1,272 square feet to 3,099. The new lease commenced in January 2026. The Company believes that its existing facilities and other available properties will be sufficient for its needs for the foreseeable future.

The Corporate Headquarters lease is set to expire in December 2030.

Item 2 of the 10-K filed Mar 9, 2026.3

Leadership

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

Board members and other officers (27)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • DirectorKatie Ellias named Aug 5, 202541

Former names

  • Big Cypress Acquisition Corp.Dec 7, 2020 to Oct 22, 20212

Timeline

  1. Oct 13, 20268-K Other events42
  2. Jul 7, 20268-K Regulation FD disclosure43
  3. Jun 18, 20268-K Shareholder vote44
  4. May 4, 20268-K Entered a material agreement45
  5. Apr 22, 20268-K Regulation FD disclosure46
  6. Mar 19, 20268-K Entered a material agreement; Other events47
  7. Mar 10, 20268-K Regulation FD disclosure; Other events48
  8. Jan 12, 20268-K Regulation FD disclosure49
  9. Jan 7, 20268-K Executive or director change; Regulation FD disclosure50
  10. Dec 29, 20258-K Other events51
  11. Sep 30, 20258-K Executive or director change52
  12. Sep 26, 20258-K Executive or director change; Shareholder vote53
  13. Oct 22, 2021New chief executive Eddie Joe Sullivan becomes CEO11
  14. Jan 11, 2021New chief executive Samuel J. Reich becomes CEO10

Calendar

Coming up

  1. Nov 13, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.21) a share, on Nov 14, 2025.54

When it reported results

  1. Mar 29, 2024Reported quarterly or annual results55
  2. Mar 31, 2023Reported quarterly or annual results56
  3. Nov 22, 2021Reported quarterly or annual results57

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

Filings

364 filings to the SEC since October 2021: 7 annual reports, 15 quarterly reports, 75 major events, 142 insider forms, 38 large holders, 2 private raises, 85 other. The latest 20:

  1. Oct 13, 20268-K EDGAR
  2. Sep 18, 20264 EDGAR
  3. Aug 21, 2026424B3 EDGAR
  4. Aug 14, 2026SCHEDULE 13G/A EDGAR
  5. Aug 14, 2026SCHEDULE 13G/A EDGAR
  6. Aug 14, 2026SCHEDULE 13G/A EDGAR
  7. Aug 14, 2026SCHEDULE 13G/A EDGAR
  8. Aug 14, 2026SCHEDULE 13G/A EDGAR
  9. Aug 14, 2026SCHEDULE 13G/A EDGAR
  10. Aug 12, 2026SCHEDULE 13G EDGAR
  11. Aug 10, 2026SCHEDULE 13D/A EDGAR
  12. Aug 6, 202610-Q EDGAR
  13. Jul 7, 20268-K EDGAR
  14. Jun 26, 20264 EDGAR
  15. Jun 18, 20268-K EDGAR
  16. May 15, 2026SCHEDULE 13G EDGAR
  17. May 15, 2026SCHEDULE 13G/A EDGAR
  18. May 15, 2026SCHEDULE 13G EDGAR
  19. May 12, 202610-Q EDGAR
  20. May 4, 20268-K EDGAR

The 364 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

10 open-market trades by officers, directors and large owners since October 2021: 9 buys and 1 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Dec 7, 2023Sullivan Eddie JoePRESIDENTBuy1,740$0.88$1.5KForm 4
Nov 30, 2023King MichaelCHIEF FINANCIAL OFFICERBuy5,000$0.90$4.5KForm 4
Nov 29, 2023Reich Samuel JCEOBuy11,000$0.89$9.8KForm 4
Sep 13, 2022HAMILTON CHRISTINE EDirectorBuy10,000$0.73$7.3KForm 4
Sep 7, 2022Sullivan Eddie JoePRESIDENTBuy14,000$0.74$10.4KForm 4
Oct 26, 2021Beyer Russell PChief Financial OfficerSale278$7.90$2.2KForm 4
Oct 14, 2021Reich Samuel JCEOBuy1,000$10.11$10.1KForm 4
Oct 13, 2021Katz IlanDirectorBuy500$10.11$5.1KForm 4
Oct 1, 2021Spragens Jeffrey GDirectorBuy13,000$10.07$130.9KForm 4
Oct 1, 2021Katz IlanDirectorBuy1,000$10.09$10.1KForm 4

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
2025Samuel J. Reich51$525.0K$9.4M74
2025Eddie J. SullivanPhD.60$485.0K$6.1M74
2025Alexandra KropotovaMD53$540.8K$5.1M74
2025Lucy To40$475.0K$2.8M74
2025Christoph BauschPhD55$425.0K$1.7M74
2024Chief Executive Officer$518.3K$2.6M74
2024President$480.9K$1.6M74
2024EVPChief Medical Officer$540.1K$1.3M74

Money raised

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

  1. Jul 21, 2025Raised $175 million in a private offering of equity Form D: 17 investors so far Form D
  2. Oct 2, 2023Raised $7.5 million in a private offering of equity Form D: 13 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 86. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Caligan Partners LP7,967,207$31.1M1.5%No change
Vivo Capital, LLC7,299,909$28.5M2.6%−4,120,091
Perceptive Advisors LLC6,627,501$25.8M0.4%+195,758
Adage Capital Partners Gp, L.l.c.6,405,553$25.0M0.0%+3,000,000
Ra Capital Management, L.P.4,401,500$17.2M0.1%No change
Balyasny Asset Management L.P.3,760,439$14.7M0.0%No change
BlackRock, Inc.3,066,016$12.0M0.0%+2,764,690
Vanguard Capital Management LLC2,972,929$11.6M0.0%+479,192
Commodore Capital LP2,870,000$11.2M0.7%−1,531,500
Millennium Management LLC2,749,087$10.7M0.0%−283,610
Spruce Street Capital LP2,198,502$8.6M1.7%No change
Sessa Capital IM, L.P.2,198,457$8.6M0.1%No change
Affinity Asset Advisors, LLC1,525,000$5.9M0.3%+950,000
Boothbay Fund Management, LLC1,481,660$5.8M0.1%No change
Geode Capital Management, LLC1,277,185$5.0M0.0%+975,149
Woodline Partners LP1,180,355$4.6M0.0%−1,671,436
Ensign Peak Advisors, Inc1,172,641$4.6M0.0%−202,969
Propel Bio Management, LLC1,076,578$4.2M2.2%+63,788
Soleus Capital Management, L.P.900,000$3.5M0.1%−150,000
Seven Fleet Capital Management LP736,077$2.9M0.5%+636,077
Ameriprise Financial Inc611,019$2.4M0.0%−865,087
State Street Corp530,831$2.1M0.0%+456,600
Susquehanna International Group, Llp438,515$1.7M0.0%New
Dv Equities, LLC400,000$1.6M0.2%New
AWM Investment Company, Inc.375,000$1.5M0.1%−25,000

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

SEC filer profile

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

  • Name on EDGARSAB Biotherapeutics, Inc.1
  • CIK0001833214
  • Employer ID (EIN)85-38997213
  • 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)2836 Biological Products, (No Diagnostic Substances)1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address777 W 41St St, Suite 401, Miami Beach, FL 331401
  • Phone305-845-28131
  • Shares outstanding90,986,368 as of Aug 3, 20269
  • Public float$76.7M as of Jun 30, 20253
  • AuditorEisnerAmper L.L.P., Iselin, New Jersey PCAOB ID 274; no auditor attestation of internal control over financial reporting3
  • On EDGAR sinceDec 7, 20201
  • Filings431 in all: 4 (112), 8-K (80), 3 (34), 425 (22), CORRESP (19), 10-Q (17), UPLOAD (14), EFFECT (12)1
    All 44 form types

    424B3 (11), SCHEDULE 13G/A (11), DEF 14A (8), SCHEDULE 13G (8), S-3 (7), 10-K (6), S-8 (6), SC 13G (5), 4/A (4), NT 10-Q (4), SC 13D/A (4), SC 13G/A (4), 424B5 (3), POS AM (3), PRE 14A (3), S-1 (3), SC 13D (3), SCHEDULE 13D/A (3), 10-K/A (2), 8-K/A (2), D (2), NT 10-K (2), S-1/A (2), S-3/A (2), S-4/A (2), 25-NSE (1), 424B4 (1), 5 (1), 8-A12B (1), AW (1), CERT (1), DEFA14A (1), DRSLTR (1), RW (1), S-4 (1), SCHEDULE 13D (1)

  • Latest filingsAnnual report (10-K) Mar 9, 2026
    Quarterly report (10-Q) Aug 6, 2026
    Proxy statement (DEF 14A) Apr 30, 2026
    Latest 8-K (8-K) Oct 13, 2026

Securities registered for trading

ClassSymbolExchange
Common stock, $0.0001 par value per shareSABSNasdaq
Warrants, each exercisable for one share of Common StockSABSWNasdaq

From the cover page of the 10-K filed Mar 9, 2026 (Section 12(b) of the Exchange Act).3

Risk factors and legal proceedings

The risks SAB Biotherapeutics, Inc. names in Item 1A of its 10-K filed Mar 9, 2026: 79 risks under these headings, as written.3

  • We are a clinical-stage biopharmaceutical company and have incurred significant losses since our inception. We expect to continue to incur net losses for the foreseeable future, and we may never achieve or maintain profitability in the future.
  • Our limited operating history makes future forecasting difficult.
  • The successful development of pharmaceutical products is highly uncertain.
  • All of our product candidates are in preclinical or clinical development. Clinical drug development is expensive, time consuming and uncertain, and we may ultimately not be able to obtain regulatory approvals for the commercialization of some or all of our product candidates.
  • Any delay in obtaining or failure to obtain required approvals could materially adversely affect our ability to generate revenue from the particular product candidate, which likely would result in significant harm to our financial position and adversely impact our stock price.
  • Regulatory approval for the genetic modification of animals, including those from which antibodies are isolated for injection into human patients, requires the approval of a New Animal Drug Application, which can be a lengthy and expensive process with uncertain outcomes, delays to which could substantially harm our business.
  • If we encounter difficulties enrolling patients in clinical trials, clinical trials of our product candidates may be delayed or otherwise adversely affected.
  • Our preclinical studies and clinical trials may fail to demonstrate substantial evidence of the safety and efficacy of our product candidates, or serious adverse or unacceptable side effects may be identified during the development of our product candidates, which could prevent, delay or limit the scope of regulatory approval of our product candidates, limit their commercialization, increase costs or necessitate the abandonment or limitation of the development of some of our product candidates.
  • Our business is highly dependent on the success of our product candidates. If we are unable to successfully complete clinical development, obtain regulatory approval for or commercialize one or more of our product candidates, or if we experience delays in doing so, our business will be materially harmed.
  • We conduct certain research and development operations through our Australian wholly-owned subsidiary. If we lose our ability to operate in Australia, or if our subsidiary is unable to receive the research and development tax credit allowed by Australian regulations, our business and results of operations could suffer.
  • The regulatory approval processes of the FDA 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.
  • We may never obtain FDA approval for any product candidates in the United States, and even if we do, we may never obtain approval for or commercialize any product candidates in any other jurisdiction, which would limit our ability to realize their full market potential.
The other 67 risks
  • The FDA or comparable foreign regulatory authorities may disagree with our regulatory plan for our product candidates.
  • If our clinical trials fail to replicate positive results from earlier preclinical studies or clinical trials conducted by us or third parties, we may be unable to successfully develop, obtain regulatory approval for or commercialize our product candidates.
  • We may incur unexpected costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
  • Even if we complete the necessary preclinical studies and clinical trials, the marketing approval process for product candidates is expensive, time-consuming and uncertain, and may prevent us from obtaining approvals for the commercialization of our product candidates.
  • If we experience delays in obtaining approval or if we fail to obtain approval of any product candidates we may develop, the commercial prospects for those product candidates may be harmed, and our ability to generate revenues will be materially impaired.
  • If we do not achieve our projected development and commercialization goals in the timeframes we announce and expect, the development and commercialization of our product candidates may be delayed, and our business and results of operations may be harmed.
  • Changes in methods of product candidate manufacturing or formulation may result in additional costs or delays.
  • Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following regulatory approval, if obtained.
  • The future commercial success of our product candidates will depend on the degree of market acceptance of our potential products among physicians, patients, healthcare payers, and the medical community.
  • Failure to successfully identify, develop and commercialize additional products or product candidates could impair our ability to grow.
  • If we are unable to develop our sales, marketing and distribution capability on our own or through collaborations with marketing partners, we will not be successful in commercializing our product candidates.
  • Product liability lawsuits against us or any of our future collaborators could divert our resources and attention, cause us to incur substantial liabilities and limit commercialization of our product candidates.
  • Our current and future relationships with customers and third-party payors in the United States and elsewhere may be subject, directly or indirectly, to applicable anti-kickback, fraud and abuse, false claims, transparency, health information privacy and security and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens and diminished profits and future earnings.
  • Regulatory approval for any approved product is limited by the FDA to those specific indications and conditions for which clinical safety and efficacy have been demonstrated.
  • Current and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize any product candidates we or our collaborators develop and may adversely affect the prices for such product candidates.
  • Even if we obtain regulatory approval for our product candidates, our products will remain subject to regulatory scrutiny.
  • A prolonged U.S. federal government shutdown could materially and adversely affect our business, operations, and legal proceedings.
  • Unfavorable global economic conditions and government regulations could adversely affect our business, financial condition or results of operations.
  • We must attract and retain highly skilled personnel and strategic partners, and we may be unable to effectively manage our growth with our limited resources.
  • We anticipate adding new employees and we will have to integrate such new employees into our operations.
  • Our employees and independent contractors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could negatively impact our business, prospects, financial condition and operating results.
  • We are limited in our ability to manufacture pharmaceutical products.
  • We depend on our senior management and senior scientific staff, and their loss or unavailability could put us at a competitive disadvantage.
  • We rely on third parties to perform some of our research and preclinical studies, and we plan to rely on third parties to conduct our clinical trials. If these third parties do not satisfactorily carry out their contractual duties or fail to meet expected deadlines, our development programs may be delayed or subject to increased costs, each of which may have an adverse effect on our business and prospects.
  • We intend to rely on third parties to produce commercial supplies of our product candidates.
  • If we fail to successfully operate our animal production facility, it may adversely affect our clinical trials and the commercial viability of our product candidates.
  • Our product candidates are uniquely manufactured, and we may encounter difficulties in production, particularly with respect to scaling our manufacturing capabilities.
  • We are subject to manufacturing risks that could substantially increase the costs and limit supply of product candidates or prevent us from achieving a commercially viable production process.
  • We and our contract manufacturers are subject to significant regulatory oversight with respect to manufacturing our products. The manufacturing facilities on which we rely may not continue to meet regulatory requirements and may have limited capacity.
  • The manufacturing facilities in which our product candidates are made could be adversely affected by equipment failures, labor shortages, natural disasters, power failures and numerous other factors.
  • Outbreaks of livestock diseases and other events affecting the health of our bovine herd can adversely impact our ability to conduct our operations and production of our product candidates.
  • Extreme factors or forces beyond our control could negatively impact our business.
  • We have not entered into long term manufacturing and supply agreements with any producers.
  • Cyber-attacks or other failures in our telecommunications or information technology systems, or those of our collaborators, CROs, third-party logistics providers, distributors or other contractors or consultants, could result in information theft, data corruption and significant disruption of our business operations.
  • Collaborations with third parties may be important to our business. If these collaborations are not successful, our business could be adversely affected.
  • We operate in a highly competitive industry.
  • We have no sales and marketing experience.
  • We are subject to stringent environmental regulation and potentially subject to environmental litigation, proceedings, and investigations.
  • If we or any contract manufacturers 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.
  • Tariffs could adversely affect our business and financial results.
  • Our success depends on our ability to maintain the proprietary nature of our technology.
  • Third parties may claim we infringe their intellectual property rights.
  • We may become involved in litigation to protect or enforce our patents or the patents of our collaborators or licensors, which could be expensive and time-consuming.
  • If patent laws or the interpretation of patent laws change, our competitors may be able to develop and commercialize our discoveries.
  • We have third party collaborators that might claim rights in or to our technology and/or assets.
  • Changes in patent law in the United States and in ex-U.S. jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • Patent applications may be denied or issued patents covering our products and product candidates could be found invalid or unenforceable.
  • We may not be able to protect our intellectual property rights throughout the world.
  • We may be unable to protect the confidentiality of our trade secrets and know-how.
  • We rely heavily on trade secrets and proprietary know-how to protect our technology, and if our employees, consultants, or collaborators disclose such information or if our Tc Bovine, HAC or proprietary cell linesare misappropriated, competitors could replicate our platform.
  • The U.S. government may have march-in rights with respect to certain of our intellectual property, which could limit our ability to exclusively commercialize products developed with government funding.
  • If we do not obtain patent term extension and data exclusivity for any product candidates we may develop, our business may be materially harmed.
  • The regulatory pathway for approval of biosimilars or interchangeable biologics to our products is uncertain, which may create competitive risks.
  • 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 Being a Public Company
  • We are an “emerging growth company,” and our election to comply with the reduced disclosure requirements as a public company may make our common stock less attractive to investors.
  • We incur increased costs and demands upon management as a result of complying with the laws and regulations affecting public companies, which could adversely affect our business, financial condition, and results of operations.
  • If we fail to maintain an effective system of disclosure controls and internal control over financial reporting, our ability to produce timely and accurate financial statements or comply with applicable regulations could be impaired.
  • Our warrants are accounted for as liabilities and changes in value of the warrants could have a material effect on our financial results.
  • Our business, financial condition, and results of operations may fluctuate on a quarterly and annual basis, which may result in a decline in our stock price if such fluctuations result in a failure to meet the expectations of securities analysts or investors.
  • Changes in accounting principles may cause previously unanticipated fluctuations in our financial results, and the implementation of such changes may impact our ability to meet our financial reporting obligations.
  • If our estimates or judgments relating to our critical accounting policies prove to be incorrect, our business, financial condition, and results of operations could be adversely affected.
  • Anti-takeover provisions contained in our certificate of incorporation as well as provisions of Delaware law, could impair a takeover attempt.
  • The market price of our securities may be volatile, which could cause the value of any investment in our securities to decline.
  • There can be no assurance that we will be able to comply with the continued listing standards of Nasdaq.
  • Because we have no current plans to pay cash dividends on our common stock for the foreseeable future, investors may not receive any return on their investment unless they sell their common stock for a price greater than the price paid.
  • Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall.
  • Future sales and issuances of our common stock or rights to purchase common stock, including pursuant to our equity plans, could result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall.

Legal proceedings

We are not currently a party to any material litigation, nor are we aware of any pending or threatened litigation against us that we believe would materially affect our business, operating results, financial condition, or cash flows. Participants in our industry face frequent claims and litigation, including securities litigation, claims regarding patent and other intellectual property rights, and other liability claims. As a result, we may be involved in various legal proceedings from time to time in the future.

The opening of Item 3, Legal Proceedings.3

Sources

The numbers on this page point here. Each one links to the record it came from.

  1. 1
  2. 2
  3. 3
  4. 4
  5. 5
  6. 6
  7. 7
  8. 8
  9. 9
  10. 10
  11. 11
  12. 12
  13. 13
  14. 14
  15. 15
  16. 16
  17. 17
  18. 18
  19. 19
  20. 20
  21. 21
  22. 22
  23. 23
  24. 24
  25. 25
  26. 26
  27. 27
  28. 28
  29. 29
  30. 30
  31. 31
  32. 32
  33. 33
  34. 34
  35. 35
  36. 36
  37. 37
  38. 38
  39. 39
  40. 40
  41. 41
  42. 42
    SEC EDGAROther events
  43. 43
  44. 44
  45. 45
  46. 46
  47. 47
  48. 48
  49. 49
  50. 50
  51. 51
    SEC EDGAROther events
  52. 52
  53. 53
  54. 54
  55. 55
  56. 56
  57. 57
  58. 58
  59. 59
  60. 60
  61. 61
  62. 62
  63. 63
  64. 64
  65. 65
  66. 66
  67. 67
  68. 68
  69. 69
  70. 70
  71. 71
  72. 72
  73. 73
  74. 74