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BCAB on OTC

BioAtla

In its 2026 annual report the company says: “We are a clinical-stage biopharmaceutical company developing our novel class of highly specific and selective antibody-based therapeutics for the treatment of solid tumor cancers. Our conditionally active biologics capitalize on our proprietary discoveries with respect to tumor biology, enabling us to target known and widely validated tumor antigens that have previously been difficult or impossible to target.”5 It was founded in 2007 by Jay Short.1 It is headquartered in San Diego.1 Its shares trade on OTC under the symbol BCAB.1

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Last updated Oct 21, 2026.

Overview

-$59.6MNet income, fiscal 20253
2007Founded1

Compare with Applied Genetic Technologies Corporation, Inhibikase Therapeutics, Inc. or Artiva Biotherapeutics, Inc., or pick any stock.

  • TickerBCAB on OTC1
  • IndustryBiological Products, (No Diagnostic Substances)1
  • HeadquartersSan Diego1
  • Websitewww.bioatla.com
  • Incorporated inDE4
  • Business address11085 Torreyana Road, San Diego, Ca 921214
  • Filer categoryNon-accelerated filer, Smaller reporting company4

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We are a clinical-stage biopharmaceutical company developing our novel class of highly specific and selective antibody-based therapeutics for the treatment of solid tumor cancers. Our conditionally active biologics (“CAB” or “CABs”) capitalize on our proprietary discoveries with respect to tumor biology, enabling us to target known and widely validated tumor antigens that have previously been difficult or impossible to target. Our novel CAB therapeutic candidates exploit characteristic pH differences between the tumor microenvironment and healthy tissue. Unlike healthy tissue, the tumor microenvironment is acidic, and we have designed our antibodies to selectively bind to their targets on cancer cells under acidic pH conditions but not on targets in normal tissues. Our approach is to identify the necessary targeting and potency required for cancer cell destruction, while aiming to elimin…5 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 2021

-32146.7%Operating margin6
-31800.7%Net margin6
-45.3%Return on equity6

Where the money goes

Where each dollar of revenue went, fiscal 2021

  • Research and development100¢$58.3M
  • Interest0¢$3.0K

Out of $300.0K in revenue.6 The company lost money this year.

Financial statements

Operating income76-$96.4M in 2021+241% since 2019
-$100.0M-$75.0M-$50.0M-$25.0M02019: -$28.3M-$28.3M20192020: -$30.1M-$30.1M2020+6%2021: -$96.4M-$96.4M2021+220%
Net income76-$95.4M in 2021+220% since 2019
-$100.0M-$75.0M-$50.0M-$25.0M02019: -$29.9M-$29.9M20192020: -$35.9M-$35.9M2020+20%2021: -$95.4M-$95.4M2021+166%

Every line of the income statement as filed: the last 2 fiscal years, latest first.3

Period ending2025-12-312024-12-31
Collaboration and other revenue$2.0M$11.0M
Research and development expense$43.6M$63.1M
General and administrative expense$17.7M$21.8M
Total operating expenses$61.3M$84.9M
Loss from operations-$59.3M-$73.9M
Interest income$843.0K$3.4M
Gain on warrant liability$295.0K$807.0K
Loss on PPAs liability-$406.0K$0
Other expense-$1.0M-$9.0K
Total other income (expense)-$302.0K$4.2M
Consolidated net loss and comprehensive loss-$59.6M-$69.8M
Net loss per common share, basic-$1.01-$1.44
Net loss per common share, diluted-$1.01-$1.44
Weighted-average shares of common stock outstanding, basic58.8M shares48.6M shares
Weighted-average shares of common stock outstanding, diluted58.8M shares48.6M shares
Related party amounts$300.0K$2.1M

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Corporate structure

BioAtla 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 BioAtla

  • BioAtla San Diego

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

What it owns

What BioAtla 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$5.4M3 Dec 31, 2025$7.7M3 Dec 31, 2024−29.3%
Accumulated depreciation$5.3M3 Dec 31, 2025$7.0M3 Dec 31, 2024−24.2%
Property and equipment, net$120.0K3 Dec 31, 2025$678.0K3 Dec 31, 2024−82.3%
Operating-lease assets (leased space)$5.5M3 Dec 31, 2025$512.0K3 Dec 31, 2024+980.5%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$7.1M3 Dec 31, 2025$49.0M3 Dec 31, 2024−85.5%

Properties, in its own words

Our headquarters are located at 11085 Torreyana Road, San Diego, California 92121, where we lease approximately 20,825 square feet of office and laboratory space under a lease that terminates on November 30, 2030. 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 31, 2026.5

The story

Founded by Jay Short in 2007.1

Leadership

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

Chief executive

  1. Jay Short2020–now

Chair

  1. Scott A. Smith2018–2023

President

  1. Scott A. Smith2020–2023

Chief financial officer

  1. Richard A. Waldron2020–2026
  2. Christian Vasquez2026–now
2010201520202025
Board members and other officers (12)

Timeline

  1. Sep 29, 20268-K Executive or director change26
  2. Aug 28, 20268-K Listing notice or transfer27
  3. Jul 16, 20268-K Shareholder vote28
  4. Apr 2, 20268-K Other events29
  5. Mar 31, 20268-K Results of operations; Regulation FD disclosure30
  6. Mar 23, 20268-K Executive or director change; Shareholder vote31
  7. Mar 2, 20268-K Results of operations; Exit or restructuring costs; Executive or director change32
  8. Feb 9, 20268-K Other events33
  9. Feb 6, 20268-K Listing notice or transfer; Regulation FD disclosure34
  10. Jan 30, 20268-K Bylaws or fiscal year changed; Shareholder vote; Regulation FD disclosure35
  11. Jan 12, 20268-K Unregistered sale of shares; Bylaws or fiscal year changed; Shareholder vote36
  12. Dec 31, 20258-K Entered a material agreement; Unregistered sale of shares; Regulation FD disclosure37
  13. Dec 15, 2020New chief executive Jay Short becomes CEO12
  14. 2007Founded Founded1

Calendar

When it reported results

  1. Mar 31, 2026Reported quarterly or annual results30
  2. Mar 2, 2026Reported quarterly or annual results32
  3. Nov 13, 2025Reported quarterly or annual results38
  4. Aug 7, 2025Reported quarterly or annual results39
  5. May 6, 2025Reported quarterly or annual results40
  6. Mar 27, 2025Reported quarterly or annual results41
  7. Nov 7, 2024Reported quarterly or annual results42
  8. Aug 8, 2024Reported quarterly or annual results43

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

Filings

418 filings to the SEC since October 2021: 6 annual reports, 15 quarterly reports, 61 major events, 248 insider forms, 34 large holders, 54 other. The latest 20:

  1. Sep 29, 20268-K EDGAR
  2. Sep 2, 20264 EDGAR
  3. Sep 2, 20264 EDGAR
  4. Sep 2, 20264 EDGAR
  5. Aug 28, 20268-K EDGAR
  6. Aug 13, 202610-Q EDGAR
  7. Jul 16, 20268-K EDGAR
  8. Jun 5, 20264 EDGAR
  9. Jun 5, 20264 EDGAR
  10. Jun 5, 20264 EDGAR
  11. Jun 3, 2026ARS EDGAR
  12. Jun 3, 2026DEFA14A EDGAR
  13. Jun 3, 2026DEF 14A EDGAR
  14. May 15, 202610-Q EDGAR
  15. Apr 29, 202610-K/A EDGAR
  16. Apr 2, 20268-K EDGAR
  17. Mar 31, 20268-K EDGAR
  18. Mar 31, 202610-K EDGAR
  19. Mar 31, 2026S-8 EDGAR
  20. Mar 23, 20268-K EDGAR

The 418 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

56 open-market trades by officers, directors and large owners since October 2021: 18 buys and 38 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Dec 26, 2023MCBRINN SYLVIADirectorBuy4,000$2.33$9.3KForm 4
Dec 20, 2023SHORT JAY M PHDChief Executive OfficerBuy50,000$2.14$107.0KForm 4
Dec 19, 2023STEINMAN LAWRENCEDirectorBuy20,000$2.05$41.0KForm 4
Dec 19, 2023Vasquez ChristianChief Financial OfficerBuy7,495$2.04$15.3KForm 4
Sep 8, 2023MCBRINN SYLVIADirectorBuy2,000$2.54$5.1KForm 4
Mar 29, 2023SHORT JAY M PHDChief Executive OfficerBuy40,800$2.47$100.8KForm 4
Mar 28, 2023MCBRINN SYLVIADirectorBuy4,000$2.35$9.4KForm 4
Mar 28, 2023Vasquez ChristianChief Financial OfficerBuy20,000$2.40$48.0KForm 4
Dec 19, 2022MCBRINN SYLVIADirectorBuy3,700$8.33$30.8KForm 4
Nov 22, 2022MCBRINN SYLVIADirectorBuy2,000$8.27$16.5KForm 4
Sep 13, 2022MCBRINN SYLVIADirectorBuy1,000$8.20$8.2KForm 4
Sep 12, 2022MCBRINN SYLVIADirectorBuy2,000$8.85$17.7KForm 4
Aug 12, 2022SHORT JAY M PHDChief Executive OfficerBuy26,350$7.84$206.6KForm 4
Jun 22, 2022SHORT JAY M PHDChief Executive OfficerBuy40,308$2.91$117.3KForm 4
Jun 21, 2022SHORT JAY M PHDChief Executive OfficerBuy29,082$2.79$81.1KForm 4
Jun 9, 2022Vasquez ChristianChief Financial OfficerBuy10,000$2.97$29.7KForm 4
Jun 8, 2022Vasquez ChristianChief Financial OfficerBuy25,848$3.02$78.1KForm 4
Jun 7, 2022Vasquez ChristianChief Financial OfficerBuy14,152$3.04$43.0KForm 4
Dec 2, 2021WALDRON RICHARD AFormer Chief Financial OfficerSale1,434$21.75$31.2KForm 4
Dec 2, 2021Vasquez ChristianChief Financial OfficerSale200$21.75$4.4KForm 4

All 56 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
2025Jay M. ShortPh.D.$734.8K$879.2K60
2025Eric SieversM.D.62$530.6K$584.4K60
2025Richard A. Waldron$485.4K$516.2K60
2024Chief Executive Officer,$734.8K$2.0M60
2024Chief Medical Officer$510.2K$961.1K60
2024Chief Financial Officer$480.6K$881.7K60

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
Millennium Management LLC70,616$292.4K0.0%New
Lido Advisors, LLC16,656$69.0K0.0%New
Stonepine Capital Management, LLC16,432$68.0K0.1%New
Geode Capital Management, LLC12,819$53.1K0.0%New
Deutsche Bank Ag\10,556$43.7K0.0%New
BlackRock, Inc.9,616$39.8K0.0%New
Vanguard Capital Management LLC9,164$37.9K0.0%New
UBS Group AG6,201$25.7K0.0%New
Vanguard Fiduciary Trust Co4,730$19.6K0.0%New
Morgan Stanley1,108$4.6K0.0%New
Tower Research Capital LLC (TRC)863$3.6K0.0%New
SBI Securities Co., Ltd.267$1.1K0.0%−10,857
Twin Lakes Capital Management, LLC144$5960.0%New
Jpmorgan Chase & Co121$4640.0%New
Barclays PLC101$4180.0%New
Jones Financial Companies Lllp40$1470.0%New
Acadian Asset Management LLC14,294$580.0%New
Hrt Financial LP13,276$540.0%New
Bnp Paribas Financial Markets7$290.0%New

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

SEC filer profile

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

  • Name on EDGARBioAtla, Inc.2
  • CIK0001826892
  • Employer ID (EIN)85-19223205
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company5
  • Incorporated inDelaware5
  • Fiscal year endsDecember 312
  • Industry code (SIC)2836 Biological Products, (No Diagnostic Substances)2
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
  • Business address11085 Torreyana Road, San Diego, CA 921212
  • Phone858-558-07082
  • Shares outstanding82,846,317 Common Stock shares; 0 Common Class B shares as of Mar 20, 20265
  • Public float$18.7M as of Jun 30, 20255
  • AuditorErnst & Young LLP, San Diego, California PCAOB ID 42; no auditor attestation of internal control over financial reporting5
  • On EDGAR sinceOct 6, 20202
  • Filings504 in all: 4 (272), 8-K (65), SC 13G/A (19), 10-Q (17), 3 (16), SC 13G (12), DEFA14A (9), CORRESP (8)2
    All 39 form types

    DEF 14A (7), S-8 (7), 10-K (6), SC 13D/A (6), UPLOAD (6), EFFECT (5), 4/A (4), 424B5 (4), ARS (4), SCHEDULE 13G/A (4), 424B2 (3), 424B3 (3), S-3 (3), SCHEDULE 13G (3), POS AM (2), S-1 (2), S-1/A (2), SEC STAFF LETTER (2), 10-K/A (1), 3/A (1), 424B4 (1), 8-A12B (1), CERT (1), DEFM14A (1), DRS (1), POSASR (1), PRE 14A (1), PREM14A (1), S-1MEF (1), S-3ASR (1), SC 13D (1)

  • Latest filingsAnnual report (10-K) Mar 31, 2026
    Quarterly report (10-Q) Aug 13, 2026
    Proxy statement (DEF 14A) Jun 3, 2026
    Latest 8-K (8-K) Sep 29, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.0001 par value per shareBCABNasdaq

From the cover page of the 10-K filed Mar 31, 2026 (Section 12(b) of the Exchange Act).5

Risk factors and legal proceedings

The risks BioAtla names in Item 1A of its 10-K filed Mar 31, 2026: 75 risks under these headings, as written.5

  • Risks related to our financial position and need for additional capital
  • We are a clinical-stage biopharmaceutical company with a limited operating history and no products approved for commercial sale. We have a history of significant losses and we expect to continue to incur significant losses for the foreseeable future, which together with our limited operating history, makes it difficult to assess our future viability.
  • 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 be forced to delay, reduce or eliminate one or more of our research and drug development programs or future commercialization efforts.
  • We have incurred significant losses and negative cash flows from operations since our inception. We may incur losses over the next several years and may never achieve or maintain profitability. Without taking other actions, these factors raise substantial doubt about our ability to continue as a going concern and we will need additional funding to continue development of our CAB technology platform and our CAB product candidates.
  • We invest a portion of our cash in a money market fund, which is vulnerable to market-specific risks that could adversely affect our business and financial condition.
  • Risks related to the discovery, development and commercialization of our product candidates
  • Our current product candidates are in various stages of development. Our product candidates may fail in development or suffer delays that adversely affect their commercial viability. If we or our existing or future collaborators are unable to complete development of, obtain regulatory approval for or commercialize our product candidates or experience significant delays in doing so, our business will be materially harmed.
  • Results from early-stage clinical trials may not be predictive of results from late-stage or other clinical trials, and the results of our clinical trials may not satisfy the requirements of the FDA, EMA or other comparable foreign regulatory authorities.
  • We are substantially dependent on the success of our patented CAB technology platform, and our future success depends heavily on the successful development of this platform.
  • We may not be successful in our efforts to use and expand our patented CAB technology platform to continue to build a pipeline of product candidates and develop marketable products.
  • We may expend our resources to pursue particular product candidates and fail to capitalize on product candidates that may be more profitable or for which there is a greater likelihood of success.
  • If the market opportunities for any product that we develop are smaller than we believe they are, our revenue may be adversely affected and our business may suffer.
The other 64 risks
  • The market may not be receptive to our product candidates because they are based on our novel therapeutic modality, and we may not generate any future revenue from the sale or licensing of product candidates.
  • Preliminary, preplanned interim and topline data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • Delays in the commencement and completion of clinical trials could increase costs and delay or prevent regulatory approval and commercialization of our product candidates.
  • Enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control.
  • Our product candidates may cause undesirable and unforeseen side effects or have other properties impacting safety that could halt their clinical development, delay or prevent their regulatory approval, limit their commercial potential or result in significant negative consequences.
  • We are developing certain of our product candidates in combination with other therapies, and regulatory approval, safety or supply issues with these other therapies may delay or prevent the development and approval of our product candidates.
  • We face competition from entities that have developed or may develop product candidates for cancer, including companies developing novel treatments and technology platforms. If these companies develop technologies or product candidates more rapidly than we do or their technologies are more effective, our ability to develop and successfully commercialize product candidates may be adversely affected.
  • Our biologic product candidates for which we intend to seek approval may face competition through an abbreviated pathway.
  • 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 approval, other legal compliance matters and taxation
  • We are currently not in compliance with Nasdaq’s continued listing requirements. If we are unable to comply with Nasdaq’s continued listing requirements, our common stock could be delisted, which could affect the price of our common stock and liquidity and reduce our ability to raise capital.
  • The Share Consolidation may not be sufficient to regain or maintain compliance with the Minimum Bid Price Requirement, and the re-pricing mechanism contained in our outstanding warrants may substantially limit the proceeds we receive from the exercise of such warrants following the Share Consolidation.
  • We may be unable to obtain U.S. or foreign regulatory approval and, as a result, unable to commercialize our product candidates.
  • We may seek Fast Track designation for one or more of our product candidates but we might not receive such designation and, even if granted, such designation may not lead to a faster development or regulatory review or approval process and does not increase the likelihood that our product candidates will receive regulatory approval.
  • If we decide to seek Orphan Drug Designation for some of our product candidates, we may be unsuccessful or may be unable to maintain the benefits associated with Orphan Drug Designation, including the potential for orphan drug exclusivity.
  • Even if we receive regulatory approval for any of our product candidates, we will be subject to ongoing regulatory 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.
  • Even if we are able to commercialize any product candidate, such product candidate may become subject to unfavorable pricing regulations or third-party coverage and reimbursement policies, which would harm our business.
  • The FDA and other comparable foreign regulatory authorities actively enforce the laws and regulations prohibiting the promotion of off-label uses.
  • Disruptions at the FDA, the SEC and other government agencies caused by, among other factors, funding shortages or global health concerns could hinder their ability to hire and retain key leadership and other personnel, otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
  • 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 of our product candidates, which would impact our business.
  • The FDA, EMA and other comparable foreign regulatory authorities may not accept data from trials conducted in locations outside of their jurisdiction.
  • Healthcare legislative reform measures may have a material adverse effect on our business and results of operations.
  • If we fail to comply with U.S. and foreign regulatory requirements, regulatory authorities could limit or withdraw any marketing or commercialization approvals we may receive and subject us to other penalties that could materially harm our business.
  • Our research and development activities could be affected or delayed as a result of possible restrictions on animal testing.
  • We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws and anti-money laundering laws and regulations. Compliance with these legal standards could impair our ability to compete in domestic and international markets. We can face criminal liability and other serious consequences for violations, which can harm our business.
  • We and our third-party contractors must comply with environmental, health and safety laws and regulations. A failure to comply with these laws and regulations could expose us to significant costs or liabilities.
  • Changes in tax laws or in their implementation or interpretation may adversely affect us or our investors.
  • Risks related to the formal process to explore and evaluate strategic options
  • We have initiated a formal process to explore and evaluate strategic options, and there is no guarantee that this strategic path will be successful.
  • If we are unable to successfully complete a strategic transaction, we may be forced to cease operations altogether or file for bankruptcy protection.
  • We may not realize any additional value in a strategic transaction.
  • If we are successful in completing a strategic transaction, we may be exposed to other operational and financial risks.
  • We may not fully realize the expected cost savings and/or operating efficiencies from our restructuring activities and our ability to consummate a strategic transaction depends on our ability to retain our employees required to consummate such transaction.
  • Transactions that we have previously entered into may be re-evaluated or restructured as part of the strategic process, and there can be no assurance that clinical development of our programs will not be limited or delayed as a result of the strategic process.
  • 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 clinical and scientific personnel, our business may be materially and adversely affected.
  • We currently have no sales organization. If we are unable to establish sales, marketing and distribution capabilities on our own or through third parties, we may not be able to market and sell our product candidates, if approved, effectively in the United States and foreign jurisdictions or generate product revenue.
  • In order to successfully implement our plans and strategies, we will need to grow the size of our organization, and we may experience difficulties in managing this growth.
  • Our employees and independent contractors, including principal investigators, CROs, consultants and vendors, may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • A portion of our research and development activities take place in China. Uncertainties regarding the interpretation and enforcement of Chinese laws, rules and regulations, a trade war, deterioration of international relations, or political unrest in China could materially adversely affect our business, financial condition and results of operations.
  • Our current operations are concentrated in one location. We or the third parties upon whom we depend may be adversely affected by earthquakes, wildfires or other natural disasters, and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
  • We face risks related to health epidemics and outbreaks, which could significantly disrupt our preclinical studies, affect enrollment of patients in our clinical trials or delay or prevent our receipt of necessary regulatory approvals.
  • Risks related to our dependence on third parties
  • We have entered, and may in the future seek to enter, into collaborations with third parties for the development and commercialization of certain of our product candidates. If we fail to enter into such collaborations, or such collaborations are not successful, we may not be able to capitalize on the market potential of our patented technology platform and resulting product candidates.
  • If our existing or future collaborators cease development efforts under our existing or future collaboration agreements, or if any of those agreements are terminated, we may lose committed funding under those agreements and these collaborations may fail to lead to commercial products and the reputation of our patented CAB technology platform may suffer.
  • We may not be successful in establishing commercialization collaborations, which could adversely affect our ability to commercialize our product candidates, if approved.
  • If third parties on which we rely to conduct our preclinical and clinical trials, do not perform as contractually required, fail to satisfy regulatory or legal requirements or miss expected deadlines, our development programs could be delayed with material and adverse effects on our business, financial condition, results of operations and prospects.
  • We rely on third parties for the manufacture of our product candidates for preclinical studies and our ongoing clinical trials, and we expect to continue to do so for additional clinical trials and ultimately commercialization. This reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or products, if approved, or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
  • The manufacture of biotechnology products is complex, and manufacturers often encounter difficulties in production. If we or any of our third-party manufacturers encounter any loss of materials or if any of our third-party manufacturers encounter other difficulties, or otherwise fail to comply with their contractual or regulatory obligations, our ability to provide product candidates for clinical trials or our products to patients, once approved, the development or commercialization of our product candidates could be delayed or stopped.
  • Risks related to intellectual property
  • If we are not able to obtain, maintain and protect our intellectual property rights in any product candidates or technologies we develop, or if the scope of the intellectual property protection obtained is not sufficiently broad, third parties could develop and commercialize products and technology similar or identical to ours, and we may not be able to compete effectively in our market.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • The terms of our patents may not protect our competitive position on our product candidates for an adequate amount of time.
  • If we do not obtain patent term extension for our product candidates, our business may be materially harmed.
  • Recent patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents.
  • Changes in U.S. patent law or laws in other countries could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
  • Other companies or organizations may challenge our or our licensors’ patent rights or may assert patent rights that prevent us from developing and commercializing our products.
  • Intellectual property rights of third parties could prevent or delay our drug discovery and development efforts and could adversely affect our ability to commercialize our product candidates, and we might be required to litigate or obtain licenses from third parties in order to discover, develop or market our product candidates. Such litigation or licenses could be costly or not available on commercially reasonable terms.
  • We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent which might adversely affect our ability to develop and market our products.
  • We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
  • We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming and unsuccessful, and issued patents covering our product candidates could be found invalid or unenforceable if challenged in court in the United States or abroad.
  • We may not be able to protect our intellectual property rights throughout the world.
  • Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities.
  • 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 candidates or we could lose certain rights to grant sublicenses.
  • We may not be successful in obtaining or maintaining necessary rights to our product candidates through acquisitions and in-licenses.
  • Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • We may be subject to claims that we or our employees or consultants have wrongfully used or disclosed alleged trade secrets of our employees’ or consultants’ former employers or their clients. These claims may be costly to defend and if we do not successfully do so, we may be required to pay monetary damages and may lose valuable intellectual property rights or personnel.
  • 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.

Legal proceedings

From time to time, we may be subject to various claims and suits arising in the ordinary course of business. We are not currently a party to any legal proceedings the outcome of which we believe, if determined adversely to us, would individually or in the aggregate have a material adverse effect on our business, operating results or financial condition.

The opening of Item 3, Legal Proceedings.5

Sources

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