Company profile

Ticker
TOCA
Exchange
CEO
Martin J. Duvall
Employees
Incorporated in
Location
Fiscal year end
SEC CIK

TOCA stock data

(
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Calendar

8 Aug 19
15 Sep 19
31 Dec 19

News

Company financial data Financial data

Quarter (USD) Jun 19 Mar 19 Dec 18 Sep 18
Revenue 9K 9K 9K 18.01M
Net income -17.11M -17.08M -19.6M -383K
Diluted EPS -0.72 -0.74 -0.96 -0.02
Net profit margin -190156% -189822% -217811% -2.13%
Operating income -16.82M -16.87M -19.11M 1.43M
Net change in cash -12.1M -9.82M 17.33M -1.13M
Cash on hand 18.9M 31M 40.81M 23.48M
Annual (USD) Dec 18 Dec 17 Dec 16 Dec 15
Revenue 18.04M 41K 49K
Net income -48.96M -38.93M -33.48M -23.06M
Diluted EPS -2.44 -2.66 -15.22 -10.57
Net profit margin -271% -94949% -68322%
Operating income -45.85M -37.63M -31.69M -22.95M
Net change in cash 4.88M 30.42M -2.64M
Cash on hand 40.81M 35.93M 5.51M 8.15M

Financial data from Tocagen earnings reports

Financial report summary

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Risks
  • We have incurred significant losses since our inception and anticipate that we will continue to incur significant losses for the foreseeable future.*
  • We will require substantial additional financing to achieve our goals, which may not be available on acceptable terms, or at all. Failure to obtain this necessary capital when needed may force us to delay, limit or terminate our product development efforts or other operations.*
  • Immunotherapy, gene therapy and biopharmaceutical product development is a highly speculative undertaking and involves a substantial degree of uncertainty. We have never generated any revenue from product sales and may never be profitable.*
  • Our gene therapy product candidates are based on novel technology, which makes it difficult to predict the time and cost of product candidate development.*
  • We expect to continue to rely on third parties to distribute, manufacture and perform release testing for our vectors, product candidates and other key materials and if such third parties do not carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approvals for our product candidates.
  • Failure to successfully develop and obtain approval of our lead product candidate, Toca 511 & Toca FC, or our other future product candidates could adversely affect our future success.
  • The FDA regulatory approval process is lengthy and time-consuming, and we may experience significant delays in the clinical development and regulatory approval of our product candidates. If we are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed.
  • Our clinical trials may fail to demonstrate safety and efficacy and any of our product candidates could be associated with undesirable side effects or other properties, which would prevent or delay regulatory approval and commercialization.
  • In third-party clinical trials involving other viral vectors for gene therapy, some patients experienced serious adverse events, including the development of leukemia due to vector-related insertional oncogenesis and death. If our vectors demonstrate a similar effect, we may be required to halt or delay clinical development of our product candidates.
  • We may not be successful in our efforts to identify or discover additional product candidates from our gene therapy platform.
  • We rely, and expect to continue to rely, on third parties to conduct, supervise and monitor our clinical trials, and if these third parties perform in an unsatisfactory manner, it may harm our business.
  • We may have difficulty enrolling patients in our clinical trials, which could delay or prevent development of our product candidates.
  • Our reliance on third parties may require us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.
  • Any adverse developments that occur during any clinical trials conducted by ApolloBio may affect our ability to obtain regulatory approval or commercialize Toca 511 & Toca FC.
  • We face intense competition and rapid technological change and the possibility that our competitors may develop therapies that are more advanced or effective than ours, which may adversely affect our financial condition and our ability to successfully commercialize our product candidates.
  • Even if we obtain regulatory approval of our product candidates, the products may not gain market acceptance among physicians, patients, hospitals, cancer treatment centers, third-party payors and others in the medical community.
  • We are highly dependent on our key personnel, and if we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.
  • We will need to expand our organization and we may experience difficulties in managing this growth, which could disrupt our operations.*
  • We may use our financial and human resources to pursue a particular research program or product candidate and fail to capitalize on programs or product candidates that may be more profitable or for which there is a greater likelihood of success.
  • We currently have a limited marketing and sales organization. If we are unable to expand our marketing and sales capabilities or enter into agreements with third parties to market and sell our product candidates, we may not be able to generate product revenue.
  • A variety of risks associated with marketing our product candidates internationally could materially adversely affect our business.
  • The terms of our Loan Agreement place restrictions on our operating and financial flexibility.
  • If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates.
  • Negative public opinion and increased regulatory scrutiny of gene therapy and genetic research may damage public perception of our product candidates or adversely affect our ability to conduct our business or obtain regulatory approvals for our product candidates.
  • Our internal computer systems, or those used by our CROs, SaaS providers, contractors or consultants, may fail or suffer security breaches.
  • Our business could be negatively impacted by cyber security threats.
  • Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.
  • The FDA may disagree with our regulatory plans, and we may fail to obtain regulatory approval of our product candidates.
  • Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions.
  • Additional time may be required to obtain regulatory approval for Toca 511 & Toca FC because it is a combination product.
  • Even if we receive regulatory approval of our product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense, and we may be subject to penalties and/or withdrawal of product approval if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates.*
  • We have Orphan-Drug Designation for Toca 511 & Toca FC for the treatment of malignant glioma in addition to glioblastoma multiforme, or GBM, but we may be unable to maintain the benefits associated with Orphan-Drug Designation, including potential eligibility for any future market exclusivity.
  • A Fast Track Designation or Breakthrough Therapy Designation by the FDA or Priority Medicines, or PRIME, Designation by the EMA, may not actually lead to a faster development or regulatory review or approval process.
  • We and our contract manufacturers are subject to significant regulation with respect to manufacturing our products. The manufacturing facilities on which we rely may not continue to meet regulatory requirements and have limited capacity.
  • Our Toca 511 & Toca FC product may face competition sooner than anticipated, if approved.
  • We may be subject, directly or indirectly, to federal, state, local and foreign healthcare fraud and abuse laws, false claims laws, privacy laws and other applicable healthcare laws, and the failure to comply with such laws could result in substantial penalties. Our employees, independent contractors, consultants, principal investigators, CROs, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.*
  • Coverage and reimbursement may be limited or unavailable in certain market segments for our product candidates, if approved, which could make it difficult for us to sell our product candidates profitably.
  • Healthcare legislative reform measures may have a material adverse effect on our business and results of operations.*
  • Due to the novel nature of our technology and the small size of our initial target patient populations, we face uncertainty related to pricing and reimbursement for these product candidates.
  • If we 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.
  • If we are unable to protect our intellectual property rights or if our intellectual property rights are inadequate for our technology and product candidates, our competitive position could be harmed.
  • Third-party claims of intellectual property infringement may prevent or delay our development and commercialization efforts.
  • We may not be successful in obtaining or maintaining necessary rights to gene therapy product components and processes for our development pipeline through acquisitions and in-licenses.
  • If we fail to comply with our obligations in the agreement under which we license intellectual property rights from the University of Southern California, or USC, or otherwise experience disruptions to our business relationships with USC or other future licensors, we could lose license rights that are important to our business.
  • 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.
  • Obtaining and maintaining our 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.
  • Issued patents covering our product candidates could be found invalid or unenforceable if challenged in court.
  • We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties or that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
  • We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
  • Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • We have not yet registered trademarks for a commercial trade name for Toca 511 & Toca FC, and failure to secure such registrations could adversely affect our business.
  • We may not be able to protect our intellectual property rights throughout the world.
  • The market price of our common stock may be highly volatile, and you could lose all or part of your investment.
  • Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and stock price.
  • We do not intend to pay dividends on our common stock so any returns will be limited to the value of our stock.
  • We are an emerging growth company, and we cannot be certain if the reduced reporting requirements applicable to emerging growth companies will make our common stock less attractive to investors.
  • We will incur significant increased costs as a result of operating as a public company, and our management will be required to devote substantial time to existing and new compliance initiatives.
  • 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 incentive plans, could result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall.*
  • We have broad discretion in the use of working capital and may not use it effectively.
  • If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.
  • Provisions in our amended and restated certificate of incorporation and amended and restated bylaws, as well as provisions of Delaware law, could make it more difficult for a third party to acquire us or increase the cost of acquiring us, even if doing so would benefit our stockholders or remove our current management.
  • Our amended and restated certificate of incorporation and amended and restated bylaws provide that the Court of Chancery of the State of Delaware is the sole and 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.
Management Discussion
  • Research and development expenses   Research and development expenses were $12.0 million and $24.4 million for the three and six months ended June 30, 2019, respectively, compared to $12.8 million and $23.2 million for the three and six months ended June 30, 2018, respectively. The decrease of $0.8 million for the three months ended June 30, 2019 compared to the same period in 2018 was primarily related to reduced clinical trial costs for the three months ended June 30, 2019 compared to June 30, 2018 as the Toca 5 trial nears completion. The $1.2 million increase for the six months ended June 30, 2019 compared to the same period in 2018 was primarily due to an increase in personnel related costs, including non-cash stock-based compensation due to increased headcount as well as manufacturing and other activities to support the potential commencement of a regulatory filing following the completion of Toca 5.
Content analysis ?
Positive
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Constraining
Legalese
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Readability
H.S. junior Avg
New words: Attorney, Fairooz, flow, Gruber, Harry, Kabbinavar, legislature, notification, truthful
Removed: accelerate, behavior, carried, collect, deductibility, forward, indefinitely, infringer, multiple, permanently, thereunder, unused