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YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
, or the failure to obtain necessary licenses, could prevent or delay us from developing and commercializing our product or product candidates, which could harm our business, financial condition and ... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
require the use of proprietary rights held by third parties, the growth of our business may depend in part on our ability to acquire, in-license, or use these third-party proprietary rights. We may ... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
perceive us to be a competitor may be unwilling to assign or license rights to us. Moreover, collaboration arrangements are complex and time-consuming to negotiate, document, implement and maintain.... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
intellectual property rights we have, we may have to abandon development of the relevant program or product candidate, which could have a material adverse effect on our business, financial condition... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
and key personnel from our business operations. In addition, in a patent infringement proceeding, a court may decide that a patent we own or in-license is not valid, is unenforceable and/or is not i... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
of novelty, obviousness, written description, non-enablement, or obviousness-type double patenting. Grounds for an unenforceability assertion could include an allegation that someone connected with ... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
any product candidates that we may develop. The outcome following legal assertions of invalidity and unenforceability is unpredictable. With respect to the validity question, for example, we cannot ... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
render our patents or our licensors’ patents invalid. There is no assurance that all potentially relevant prior art relating to our patents and patent applications, or the patents and patent applica... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
or strength of protection provided by our patents and patent applications or the patents and patent applications of our licensors is threatened, it could dissuade companies from collaborating with u... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
substantially increase our operating losses and reduce the resources available for development activities or any future sales, marketing or distribution activities. We may not have sufficient financ... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
the right to practice the patented invention. Third parties may have blocking patents that could prevent us from marketing our own patented product and practicing our own patented technology.
Intel... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
could have a material adverse effect on our business.
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Derivation proceedings may be necessary to determine priority of inventions, and an unfavorable outcome may require us t... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
and distract our management and other employees. In addition, the uncertainties associated with such proceedings could have a material adverse effect on our ability to raise the funds necessary to c... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
that affect the way patent applications will be prosecuted and may also affect patent litigation. In particular, under the Leahy-Smith Act, the United States transitioned in March 2013 to a “first i... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
. Furthermore, our ability to obtain and maintain valid and enforceable patents depends on whether the differences between our technology and the prior art allow our technology to be patentable over ... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
to attack the validity of a patent by USPTO administered post-grant proceedings, including PGR, IPR, and derivation proceedings. An adverse determination in any such submission or proceeding could r... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
claims that would not have been invalidated if first challenged by the third party as a defendant in a district court action. Thus, the Leahy- Smith Act and its implementation could increase the unc... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
high degree of technological and legal complexity. Therefore, obtaining and enforcing pharmaceutical patents is costly, time consuming and inherently uncertain. Changes in either the patent laws or ... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has
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created uncertainty with respect to the value... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
. Confidentiality and intellectual property assignment agreements may not be honored and may not effectively assign intellectual property rights to us. The assignment of intellectual property rights ... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
substantial costs and distraction to management and other employees.
Patent terms may be inadequate to protect our competitive position on our product or product candidates that we may develop in t... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our patent portfolio may not pro... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
The Hatch-Waxman Amendments permit a patent restoration term of up to five years as compensation for patent term lost during product development and the FDA regulatory review process. A maximum of o... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
relevant patents or otherwise failing to satisfy applicable requirements. Moreover, the applicable time period or the scope of patent protection afforded could be less than we request or require. If... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
United States and pending patent applications in the United States and other countries, filing, prosecuting and defending patents on our product or product candidates in all countries and jurisdicti... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
deadlines for pursuing patent protection in individual foreign jurisdictions are based on the priority date of each of our patent applications and we may not timely file foreign patent applications.
... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
ents granted before the implementation of the UPC will have the option of opting out of the jurisdiction of the UPC and remaining as national patents in the UPC countries. Patents that remain under t... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
, the patents of our licensors, or other intellectual property rights may not be effective or sufficient to prevent them from competing. Even if we pursue and obtain issued patents in particular juri... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
our patents or the patents of our licensors at risk of being invalidated or interpreted narrowly and our patent applications or the patent applications of our licensors at risk of not issuing and co... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
remedies, which could materially diminish the value of such patent. If we are forced to grant a license to third parties with respect to any patents relevant to our business, our competitive positio... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
and/or applications and those of our licensors and any patent rights we may own or license in the future. We have systems in place to remind us to pay these fees, and, in certain instances, we rely ... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. If such an event were to occur, competitors or other third parties ... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
on other marks. We may not be able to protect our rights to these trademarks and trade names, which we need to build name recognition among potential partners or customers in our markets of interest... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
trade secrets, domain names, copyrights or other intellectual property may be ineffective and could result in substantial costs and diversion of resources and could adversely affect our financial co... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
and we have limited control over the protection of trade secrets used by such third parties. Although we have taken steps to protect our trade secrets and unpatented know-how, including by entering ... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
have rights to publish data, provided that we are notified in advance and may delay publication for a specified time in order to secure our intellectual property rights arising from the collaboratio... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
of the substantial amount of discovery required in connection with intellectual property litigation or other proceedings, there is a risk that some of our confidential information could be compromis... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
consultants or advisors have wrongfully used or disclosed alleged confidential information or trade secrets.
We have entered into and will enter in the future into non-disclosure and confidentialit... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
its outcome, may cause negative publicity and could prohibit us from marketing or otherwise commercializing our product or product
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candidates and technology. Failure to defen... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
may have previously provided or may be currently providing consulting services to, other pharmaceutical companies including competitors or our potential competitors. We may become subject to claims ... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
subject, in part, to the terms and conditions of licenses granted to us by others.
We have entered into license agreements with third parties and we may enter into additional license agreements in ... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
such an event, we cannot be certain that these patents and patent applications will be prepared, filed, prosecuted, maintained, enforced, and defended in a manner consistent with the best interests ... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
license such patents to our competitors, and our competitors could market competing products and technology. This could have a material adverse effect on our competitive position, business, financia... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
may be unable to develop or commercialize the affected product or product candidates, which could harm our business, financial condition, results of operations, and prospects significantly. We canno... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
es may arise between us and our licensors regarding intellectual property subject to a license agreement, including:
the scope of rights granted under the license agreement and other interpretation-... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
third parties are complex, and certain provisions in such agreements may be susceptible to multiple interpretations. The resolution of any contract interpretation disagreement that may arise could n... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
best efforts, our licensors might conclude that we have materially breached our license agreements and might therefore terminate the license agreements, thereby removing our ability to develop and c... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
candidates, there may be times when the filing and prosecution activities for patents are controlled by our licensors or collaboration partners, including those licensed to us under our license agre... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
. Also, we rely on numerous third parties to provide us with materials that we use to develop our technology. If we cannot successfully negotiate sufficient ownership, licensing, and/or commercial ri... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
that took place prior to the date upon which we assumed control over patent prosecution.
Intellectual property discovered through government funded programs may be subject to federal regulations su... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
future, intellectual property rights that have been generated through the use of United States government funding or grant. Pursuant to the Bayh-Dole Act of 1980, the United States government has ce... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
is necessary to meet requirements for public use under federal regulations (“march-in rights”). The United States
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government also has the right to take title to these inventi... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
show that reasonable but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the United States or that ... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
proceedings in the ordinary course of business relating to our collaboration partners, directors, officers, stockholders, intellectual property rights, employment matters and the safety or efficacy ... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
defending against such litigation and legal proceedings may be significant and there can be no assurance that we will be successful in any defense. Further, the amount of time that may be required t... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
reputation and business. Litigation and legal proceedings are subject to inherent uncertainties, and an adverse result in such matters that may arise from time to time could have a material adverse ... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
include:
our ability to obtain regulatory approvals for FYARRO in other indications or for any other product candidates that we may develop in the future, and delays or failures to obtain such appr... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
regulatory authority decisions;
the initiation of material developments in, or conclusion of, disputes or litigation to enforce or defend any of our intellectual property rights or defend against t... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
our operating performance or the operating performance of our competitors, including deteriorating market conditions due to investor concerns regarding inflation and hostilities between Russia and U... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
our business and stock;
changes in the market valuations of similar companies;
general and industry-specific economic conditions potentially affecting our research and development expenditures;
s... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
have often instituted class action securities litigation against those companies. Regardless of the merits or the ultimate results of such litigation, if instituted, such litigation could result in ... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
reporting may be adversely affected, which could have a material adverse effect on our business and stock price.
We must maintain effective internal control over financial reporting in order to acc... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
and weaknesses or fail to remediate previously identified deficiencies in our internal controls.
The rules governing the standards that must be met for our management to assess our internal control... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
, including the requirements of the Sarbanes-Oxley Act, our business and reputation may be harmed and our stock price may decline. Furthermore, investor perceptions of us may be adversely affected, w... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets, liabilities, equity, and expenses that are not... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
and could fall below our publicly announced guidance or the expectations of securities analysts and investors, resulting in a decline in the market price of our common stock.
We will continue to in... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
In addition, regulations and standards relating to corporate governance and public disclosure, including the SOX, and the related rules and regulations implemented by the SEC and The Nasdaq Stock Ma... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
director and officer liability insurance, and we may be required to accept reduced coverage or incur substantially higher costs to obtain coverage. These factors could also make it more difficult fo... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
” which will require brokers trading in our common stock to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for our securitie... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
on the prevailing market price of our common stock.
On April 15, 2021, we filed a universal shelf registration statement on Form S-3 (the “Shelf Registration Statement”) to offer up to $150 million... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
float requirement, any offering by us under the Shelf Registration Statement or any future registration statement on Form S-3 that we may file with the SEC will be limited to raising an aggregate of... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
under our employee equity incentive plans. These shares will be able to be sold freely in the public market upon issuance.
Our principal stockholders and management own a significant percentage of ... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
feel are in your best interest as one of our stockholders. The interests of this group of stockholders may not always coincide with your interests or the interests of other stockholder and they may ... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
, conflicts in Eastern Europe, potential uncertainty related to Taiwan and its relationship with China, increasing interest rates, adverse developments affecting the financial services industry and g... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
risks to our business, including, weakened demand for FYARRO or our any of our future product candidates and our ability to raise additional capital when needed on acceptable terms, if at all. A wea... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
limit our ability to conduct clinical trials outside the United States or result in material implications for our business. In addition, our insurance policies typically contain a war exclusion of s... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
the future lead to market-wide liquidity problems. For example, on March 10, 2023, Silicon Valley Bank was closed by the California Department of Financial Protection and Innovation, which appointed... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
constraints or failures, the ability to perform obligations under various types of financial, credit or liquidity agreements or arrangements, disruptions or instability in the financial services ind... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
be affected by political or civil unrest or military action, including the current conflict between Russia and Ukraine, terrorist activity, unstable governments and legal systems. As a result of glo... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
results of operations.
Additionally, there is ongoing uncertainty regarding the federal budget and federal spending levels, including the possible impacts of a failure to increase the “debt ceiling... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
be certain whether the reduced disclosure requirements applicable to smaller reporting companies will make our common stock less attractive to investors or otherwise limit our ability to raise addit... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
, only being required to provide two years of audited financial statements in annual reports. Reduced disclosure in our SEC filings due to our status as a smaller reporting company may make it harder... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
.
The trading market for our common stock will be influenced by the research and reports that industry or equity research analysts publish about us and our business. Equity research analysts may ele... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
trading volume to decline.
Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition of us more difficult and may prevent attempts our stockholders to repla... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
with us in certain circumstances. Although we believe these provisions collectively will provide for an opportunity to receive higher bids by requiring potential acquirers to negotiate with our boar... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
or other employees.
Our bylaws provide that the Court of Chancery of the State of Delaware (or, if the Court of Chancery of the State of Delaware does not have jurisdiction, the federal district co... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
restated certificate of incorporation or our bylaws (including the interpretation, validity or enforceability thereof), or (iv) any action asserting a claim against us that is governed by the intern... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
a judicial forum that it
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Table of Contents
finds favorable for disputes with us or our directors, officers or other employees, which may discourage such lawsuits against us and our directors,... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
headquarters consist of 2,760 square feet of leased office space in Pacific Palisades, California. Our Pacific Palisades lease expires on February 28, 2025.
We also lease 10,615 square feet of offi... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
. Mine Safety Disclosures.
Not applicable.
101
Table of Contents
PART II
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
Ma... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
business. The declaration of any future cash dividends, if any, would be at the discretion of our board of directors (subject to limitations imposed under applicable Delaware law) and would depend o... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
Operations.
The following discussion of our financial condition and results of operations should be read in conjunction with the consolidated financial statements and the related notes to those sta... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
1A (Risk Factors) of this Annual Report and the “Cautionary Statement Regarding Forward-Looking Statements” sections of this Annual Report for a discussion of important factors that could cause actu... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
rolimus bound to albumin. Sirolimus is a potent inhibitor of the mTOR biological pathway, the activation of which pathway can promote tumor growth. We believe our approach to utilizing albumin bound ... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
PEComa”). On February 22, 2022, we launched FYARRO in the United States for treatment of advanced malignant PEComa. For the fiscal year ended
December 31, 2022
, we recorded net revenue from produc... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
Tuberous Sclerosis Complex 1 and 2 (“
TSC1
TSC2
”) alterations. We have completed a Type B meeting with the FDA in which we discussed the trial design and the PRECISION 1 trial was opened for enr... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
board of directors appointed Brendan Delaney, our former Chief Operating Officer, to President and Chief Executive Officer and Neil Desai, our founder, director, and former-President and Chief Execu... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
In addition, Dr. Desai, the founder of the company and our President and Chief Executive Officer prior to Mr. Delaney, continues to serve as the Executive Chairman and a member of our board of direc... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
on September 26, 2022, we sold (i) 3,373,526 shares of our common stock, at a purchase price of $12.50 per share, and (ii)
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Table of Contents
2,426,493 pre-funded warrants (the “Pre-Funded War... |
YOU are a financial analyst. You are reading a report of a company.
The report is about the company's financial status.
Registration Rights Agreement”), with the 2022 PIPE Investors. Pursuant to the 2022 PIPE Registration Rights Agreement, on October 26, 2022, we filed a registration statement with the Securities and... |
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