Company profile

Ticker
STSA
Exchange
CEO
John A. Kollins
Employees
Incorporated in
Location
Fiscal year end
SEC CIK
IRS number
813039831

STSA stock data

(
)

Investment data

Data from SEC filings
Securities sold
Number of investors

Calendar

12 Nov 19
28 Jan 20
31 Dec 20

News

13F holders
Current Prev Q Change
Total holders 30 0 +Infinity%
Opened positions 30 0 +Infinity%
Closed positions 0 0 NaN%
Increased positions 0 0 NaN%
Reduced positions 0 0 NaN%
13F shares
Current Prev Q Change
Total value 201.41M 0 +Infinity%
Total shares 13.44M 0 +Infinity%
Total puts 0 0
Total calls 0 0
Total put/call ratio
Largest owners
Shares Value Change
Ra Capital Management 4.68M $70.28M NEW
Wellington Management 2.41M $35.78M NEW
TPG 1.89M $28.31M NEW
Citadel Advisors 958.38K $14.39M NEW
Caxton 870.82K $13.07M NEW
Cormorant Asset Management 858.38K $12.88M NEW
Adage Capital Partners GP, L.L.C. 610K $9.16M NEW
Eventide Asset Managment 425K $6.38M NEW
CS Credit Suisse 308.58K $4.63M NEW
Zimmer Partners 100K $1.5M NEW
Largest transactions
Shares Bought/sold Change
Ra Capital Management 4.68M +4.68M NEW
Wellington Management 2.41M +2.41M NEW
TPG 1.89M +1.89M NEW
Citadel Advisors 958.38K +958.38K NEW
Caxton 870.82K +870.82K NEW
Cormorant Asset Management 858.38K +858.38K NEW
Adage Capital Partners GP, L.L.C. 610K +610K NEW
Eventide Asset Managment 425K +425K NEW
CS Credit Suisse 308.58K +308.58K NEW
Zimmer Partners 100K +100K NEW

Financial report summary

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Risks
  • We are a clinical-stage biopharmaceutical company with a limited operating history and no products approved for commercial sale. We have incurred significant losses since our inception, and we anticipate that we will continue to incur significant losses for the foreseeable future, which, together with our limited operating history, makes it difficult to assess our prospects.
  • We will require substantial additional financing to achieve our goals, and a failure to obtain this capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product development or commercialization efforts.
  • Our business is entirely dependent on the successful development, regulatory approval and commercialization of STS101, our only product candidate under development.
  • We have only recently begun testing STS101 in patients with migraine to assess its effectiveness, and, while we believe that it will be an effective acute treatment for migraine based on the historical pharmacokinetic profiles and effective usage of DHE products, we are utilizing a novel dry-powder formulation and delivery device which may not achieve better or similar levels of efficacy as other DHE products. Further, the results of earlier studies and trials of other DHE products, including cross-trial comparisons of results that are not derived from head-to-head clinical trials, may not be predictive of future trial results for STS101.
  • Clinical development involves a lengthy and expensive process with an uncertain outcome, and delays can occur for a variety of reasons outside of our control.
  • We may be unable to obtain regulatory approval for STS101 under applicable regulatory requirements. The denial or delay of any such approval would delay commercialization of STS101 and adversely impact our potential to generate revenue, our business and our results of operations.
  • If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
  • STS101 may cause undesirable side effects or have other properties that could delay or prevent its regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any.
  • We may be unable to rely on Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act (FDCA), which could result in a longer development program and more costly trials than we anticipate.
  • STS101 is a drug-device combination product, which may result in additional regulatory risks.
  • Even if STS101 obtains regulatory approval, it may fail to achieve broad market acceptance.
  • We face, and will continue to face, significant competition in an environment of rapid technological and scientific change and our failure to effectively compete may prevent us from achieving significant market penetration for STS101, if approved. Most of our competitors have significantly greater resources than we do and we may not be able to successfully compete.
  • The successful commercialization of STS101 will depend in part on the extent to which governmental authorities, private health insurers, and other third-party payors provide coverage, adequate reimbursement levels and implement pricing policies favorable for it. Failure to obtain or maintain coverage and adequate reimbursement for STS101, if approved, could limit our ability to market our product and decrease our ability to generate revenue.
  • We currently have no sales organization. If we are unable to establish sales capabilities on our own or through third parties, we may not be able to market and sell STS101 effectively in the United States and foreign jurisdictions, if approved, or generate product revenue.
  • We rely, and intend to continue to rely, on qualified third parties to supply all components of STS101. As a result, we are dependent on several third parties, most of which are sole source suppliers, for the manufacture of STS101 and our supply chain, and if we experience problems with any of these suppliers, or they fail to comply with applicable regulatory requirements or to supply sufficient quantities at acceptable quality levels or prices, or at all, it would materially and adversely affect our business.
  • We rely, and intend to continue to rely, on third-party suppliers for materials used in the manufacture of STS101, and the loss of third-party suppliers or their inability to supply us with adequate key materials could harm our business.
  • We rely, and intend to continue to rely, on third parties in the conduct of all of our clinical trials. If these third parties do not successfully carry out their contractual duties, fail to comply with applicable regulatory requirements or meet expected deadlines, we may be unable to obtain regulatory approval for STS101.
  • The terms of our loan agreement place restrictions on our operating and financial flexibility.
  • We will need to increase the size of our organization, and we may experience difficulties in managing growth.
  • If we fail to attract and retain senior management and key scientific personnel, our business may be materially and adversely affected.
  • If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of STS101.
  • Our insurance policies may be inadequate and potentially expose us to unrecoverable risks.
  • We may conduct additional clinical trials and consider additional headache indications for STS101 to enhance its commercial potential; however, these trials may not produce results necessary to enable additional commercial potential or enhancement of its label.
  • Any future collaboration arrangements that we may enter into, may not be successful, which could significantly limit the likelihood of receiving the potential economic benefits of the collaboration and adversely affect our ability to develop and commercialize STS101.
  • If we engage in future acquisitions or strategic partnerships, this may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities, and subject us to other risks.
  • We or the third parties upon which we depend may be adversely affected by earthquakes or other natural disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
  • We depend on our information technology systems, and any failure of these systems could harm our business. Any real or perceived security breaches, loss of data, and other disruptions or incidents could compromise the privacy, security, integrity or confidentiality of sensitive information related to our business or prevent us from accessing critical information and expose us to liability and reputational harm, which could adversely affect our business, results of operations and financial condition.
  • Our employees and independent contractors, including principal investigators, consultants, commercial collaborators, service providers and other vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have an adverse effect on our results of operations.
  • Our business involves the use of hazardous materials and we and our third-party manufacturers and suppliers must comply with environmental laws and regulations, which can be expensive and restrict how we do business.
  • Unfavorable global economic or political conditions could adversely affect our business, financial condition or results of operations.
  • Our success depends on our ability to protect our intellectual property and our proprietary technologies.
  • The lives of our patents may not be sufficient to effectively protect STS101 and our business.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • Our rights to develop and commercialize STS101 are subject in part to the terms and conditions of a license granted to us by SNBL. The patent protection, prosecution and enforcement for STS101 may be dependent on third parties.
  • Litigation or other proceedings or third-party claims of intellectual property infringement could require us to spend significant time and money and could prevent us from selling our products.
  • 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. Further, issued patents relating to STS101 could be found invalid or unenforceable if challenged in court.
  • We may fail to comply with our obligations under the SNBL License or any future agreements pursuant to which we may license or otherwise acquire intellectual property rights or technology, which could result in the loss of rights or technology that are material to our business.
  • We may be subject to claims that we have wrongfully hired an employee from a competitor or that we or our employees have wrongfully used or disclosed alleged confidential information or trade secrets of their former employers.
  • We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
  • 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.
  • Changes in patent law in the U.S. or in other countries could diminish the value of patents in general, thereby impairing our ability to protect STS101.
  • We may not be able to protect our intellectual property rights throughout the world.
  • 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.
  • Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
  • If STS101 obtains regulatory approval, competitors could enter the market with generic versions, which may result in a material decline in sales of affected products.
  • The successful commercialization of STS101 will depend in part on the extent to which governmental authorities, private health insurers, managed care plans and other third-party payors provide coverage, adequate reimbursement levels and implement pricing policies favorable for STS101. Failure to obtain or maintain coverage and adequate reimbursement for STS101, if approved, could limit our ability to market those products and decrease our ability to generate revenue.
  • Our business operations and current and future relationships with investigators, healthcare professionals, consultants, third-party payors, patient organizations and customers will be subject to applicable healthcare regulatory laws, which could expose us to penalties.
  • Enacted and future healthcare legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize STS101 and may affect the prices we may set.
  • Changes in and failures to comply with U.S. and foreign privacy and data protection laws, regulations and standards may adversely affect our business, operations and financial performance.
  • Our stock price may be volatile and you may not be able to resell shares of our common stock at or above the price you paid.
  • An active, liquid and orderly market for our common stock may not develop.
  • If securities or industry analysts do not publish research or reports about our business, or if they issue an adverse or misleading opinion regarding our stock or business, our stock price and trading volume could decline.
  • We are an “emerging growth company” and as a result of the reduced disclosure and governance requirements applicable to emerging growth companies, our common stock may be less attractive to investors.
  • We incur increased costs as a result of operating as a public company, and our management devotes substantial time to compliance initiatives. We may fail to comply with the rules that apply to public companies, including Section 404, which could result in sanctions or other penalties that would harm our business.
  • We identified a material weakness in our internal control over financial reporting at December 31, 2017 and 2018, and we may identify additional material weaknesses in the future that may cause us to fail to meet our reporting obligations or result in material misstatements of our financial statements. If we fail to remediate any material weaknesses or if we otherwise fail to establish and maintain effective control over financial reporting, our ability to accurately and timely report our financial results could be adversely affected.
  • If we sell shares of our common stock in future financings, stockholders may experience immediate dilution and, as a result, our stock price may decline.
  • 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.
  • Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall.
  • Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
  • Recent U.S. tax legislation and future changes to applicable U.S. tax laws and regulations may have a material adverse effect on our business, financial condition and results of operations.
  • Provisions in our charter documents and under Delaware law could discourage a takeover that stockholders may consider favorable and may lead to entrenchment of management.
  • Claims for indemnification by our directors and officers may reduce our available funds to satisfy successful third-party claims against us and may reduce the amount of money available to us.
  • We do not currently intend to pay dividends on our common stock, and, consequently, your ability to achieve a return on your investment will depend on appreciation in the price of our common stock.
Management Discussion
  • Research and development expenses increased by $6.1 million, or 439%, from the three months ended September 30, 2018 to the three months ended September 30, 2019. The increase in research and development expenses was primarily due to an increase of $5.3 million in fees paid to CROs and CMOs as a result of increased clinical trial activities, an increase of $0.5 million in payroll and personnel expenses, including salaries, benefits and stock-based compensation expenses, due to increases in headcount, and an increase of $0.3 million in allocated overhead, including depreciation and travel expenses.
  • General and administrative expenses increased by $0.8 million, or 368%, from the three months ended September 30, 2018 to the three months ended September 30, 2019. The increase in general and administrative expenses was primarily due to an increase of $0.3 million of payroll and personnel expenses, including salaries, benefits and stock-based compensation expenses, due to increases in headcount, and an increase of $0.5 million of professional fees for legal, consulting, accounting, tax and other services.
  • Interest income increased by $0.3 million from the three months ended September 30, 2018 to the three months ended September 30, 2019, which was primarily attributable to interest income from cash and cash equivalents and short-term marketable securities.
Content analysis ?
Positive
Negative
Uncertain
Constraining
Legalese
Litigous
Readability
H.S. junior Avg

Proxies

No filings