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New words:
adequacy, bid, cap, clarity, COBRA, consummate, consummated, consummating, consummation, conversion, CVR, cybersecurity, deficiency, delisted, divided, energy, ESMO, excise, explanation, explicitly, explore, exploring, expressly, FDORA, frame, freeze, gap, Halozyme, harmonized, HHS, HNSCC, Imjudo, intriguing, IRA, isolating, killer, Labcorp, loan, long, meant, mutual, naive, NK, nonpromotional, Opdulag, ordinary, OTC, outpace, outplacement, overrule, passage, penalize, pendency, penny, Pharma, PIE, pink, platinum, POC, PREA, prespecified, proactively, professional, propagation, pulsatile, pursuit, ransom, ransomware, recommence, Redmile, Redx, reestablish, regain, renal, RM, run, sanction, sanctioned, scheme, send, Shield, Simon, split, step, stringent, subordinated, subsidy, tying, underway, undisclosed, unsecured
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absence, adjusting, Aggressively, allocable, analyzed, applicability, baseline, binding, broaden, capacity, clarifying, cleared, cold, contemplate, contemporaneously, coordination, deplete, device, diagnostic, dynamic, ease, emerging, essential, evolving, flexibility, flexible, forecast, genetic, GlaxoSmithKline, half, ICONIC, immaterial, importance, infeasible, interaction, interplay, JSC, Jumpstart, King, learning, leave, logistical, London, mitigate, newly, optional, pair, peripheral, point, premarket, presence, qualitatively, quantitatively, Radiological, reliably, resistance, retrospectively, RNA, scalable, scale, secured, selectively, seventeen, shortage, signaling, steering, stipulated, survival, talent, unresponsive
Financial report summary
?Competition
Bristol-Myers Squibb • Pfizer • Regeneron Pharmaceuticals • Astrazeneca • Portage Biotech • Agenus • Infinity Pharmaceuticals • GSK • Xencor • Ngm BiopharmaceuticalsRisks
- Consummation of the Business Combination with Redx Pharma plc, or Redx, is subject to approval by Redx’s shareholders, the sanction of the High Court of Justice of England and Wales, or the Court, and satisfaction of other closing conditions, including our stockholders’ approval of the issuance of new shares of common stock, which, if delayed or not granted or granted with unacceptable conditions, may prevent, delay or impair the consummation of the transaction, result in additional expenditures of money and resources, subject us to business uncertainties that could adversely affect our business and operations, and/or reduce the anticipated benefits of the Business Combination.
- Even if we successfully consummate the Business Combination with Redx, we may fail to realize all of the anticipated benefits of the transaction, those benefits may take longer to realize than expected, or we may encounter integration difficulties.
- If the Business Combination is not completed, we may not be able to identify or complete an alternative strategic transaction on terms that are as favorable as the terms of the proposed transaction with Redx, or at all, and we may be unable to reestablish a viable operating business.
- Our stockholders may not receive any payment on the CVRs, and the CVRs may expire valueless.
- There will be risks associated with the Business Combination.
- We are early in our development efforts. If we are unable to advance our product candidates through clinical development, advance future product candidates to clinical development or obtain marketing approval and ultimately commercialize any product candidates or experience significant delays in doing so, our business will be materially harmed.
- Clinical product development involves a lengthy and expensive process, with an uncertain outcome. We will incur additional costs in connection with, and may experience delays, in completing, or ultimately be unable to complete, the development and commercialization of our current and future product candidates.
- Our current and future product candidates may cause undesirable side effects or have other properties when used alone or in combination with other approved pharmaceutical products or investigational new drugs that could halt their clinical development, prevent their marketing approval, limit their commercial potential or result in significant negative consequences.
- If we encounter difficulties retaining patients in our clinical trials or enrolling patients in future trials, if any, our clinical development activities could be delayed or otherwise be adversely affected.
- We are currently conducting SELECT outside the United States and may conduct future clinical trials for our product candidates at sites outside the United States, and the FDA may not accept data from trials conducted in such locations or the complexity of regulatory burdens may otherwise adversely impact us.
- Even if we complete the necessary preclinical studies and clinical trials, the marketing approval process is expensive, time consuming and uncertain and may prevent us or any of our existing or future collaborators or licensees from obtaining approvals for the commercialization of our current and future product candidates.
- We may seek Orphan Drug Designation for our current and future product candidates, and we may be unsuccessful or may be unable to maintain the benefits associated with Orphan Drug Designation, including the potential for market exclusivity.
- We may choose not to develop a potential product candidate, or we may suspend or terminate one or more discovery or preclinical programs or our product candidates.
- Obtaining and maintaining marketing approval of our current or future product candidates in one jurisdiction does not mean that we will be successful in obtaining marketing approval of that product candidate in other jurisdictions.
- Our failure to successfully identify, discover, acquire, develop or commercialize additional products or product candidates could impair our ability to grow.
- Even if we receive marketing approval of our current or future product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review.
- We rely and expect to continue to rely on third parties to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties, comply with regulatory requirements or meet expected deadlines, we may not be able to obtain marketing approval for or commercialize our product candidates and our business could be substantially harmed.
- Because we rely on third-party manufacturing and supply partners, including a single supplier for some of our materials, our supply of research and development, preclinical and clinical development materials may become limited or interrupted or may not be of satisfactory quantity or quality.
- We expect to develop our current and future product candidates in combination with other drugs. If we are unable to enter into a strategic collaboration for, or if we are unable to purchase on commercially reasonable terms, an approved or investigational cancer drug to use in combination with our product candidates, we may be unable to develop or obtain approval for our current and future product candidates in combination with other drugs.
- We are subject to manufacturing risks that could substantially increase our costs and limit the supply of our products.
- We face significant competition and if our competitors develop and market products that are more effective, safer or less expensive than any of our current or future product candidates, our commercial opportunities will be negatively impacted.
- We may depend on third parties for the development and commercialization of our product candidate programs. If these programs are not successful, we may not receive significant payments from such third parties or we may not be able to capitalize on the market potential of these product candidates.
- We may seek to establish additional collaborations, and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development and commercialization plans.
- The market opportunities for our current and future products, if and when approved, may be limited to those patients who are ineligible for established therapies or for whom prior therapies have failed, and may be small.
- If product liability lawsuits are brought against us, we may incur substantial liabilities.
- Adverse events in the field of immuno-oncology could damage public perception of our product candidates and negatively affect our business.
- Healthcare legislative reform measures may have a material adverse effect on our business and results of operations.
- Our future relationships with customers and third-party payors in the United States and elsewhere may be subject, directly or indirectly, to applicable anti-kickback, fraud and abuse, false claims, transparency, health information privacy and security and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens and diminished profits and future earnings.
- We have accumulated significant losses since our inception and anticipate that we will continue to incur substantial net losses in the foreseeable future.
- We have never generated any revenue from product sales and our ability to generate revenue from product sales and become profitable depends on our success on a number of factors.
- We will require substantial additional financing to achieve our goals, and a failure to obtain this necessary capital when needed could force us to delay, limit, reduce or terminate our product development or commercialization efforts.
- Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or our current and future product candidates.
- If we are unable to obtain, maintain and protect our intellectual property rights for our product candidates or if our intellectual property rights are inadequate, our competitive position could be harmed.
- Patent terms may be inadequate to protect our competitive position on our products for an adequate amount of time, and our current and future product candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated.
- If we are unable to protect the confidentiality of our proprietary information and know-how, the value of our technology and products could be adversely affected.
- Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could harm our business.
- If we breach any of our license agreements or collaboration agreements, it could have a material adverse effect on our commercialization efforts for our product candidates.
- We may not be successful in obtaining necessary rights to our product candidates we may develop or obtain 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.
- Changes to the patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
- We may become involved in lawsuits to protect or enforce our intellectual property, which could be expensive, time-consuming and unsuccessful and have a material adverse effect on the success of our business.
- We may be subject to claims by third parties asserting that our collaborators, licensors, employees or we have misappropriated their intellectual property, have wrongfully used or disclosed confidential information of third parties or are in breach of non-competition or non-solicitation agreements with our competitors.
- Issued patents covering our current and future product candidates could be found invalid or unenforceable if challenged in court or before the USPTO or comparable foreign authority.
- We are substantially dependent on our remaining employees to facilitate the consummation of the Business Combination.
- We are highly dependent on our key personnel, and if we are not successful in attracting, motivating and retaining highly qualified personnel, we may not be able to successfully implement our business strategy. Workforce reductions may have an adverse impact on our ability to retain key personnel.
- We currently have no marketing and sales organization and have no experience in marketing products. If we are unable to establish 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.
- Our employees, independent contractors, vendors, principal investigators, CROs and consultants may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading.
- 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 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.
- Our internal information technology systems, or those used by our CROs or other third parties, may fail or suffer security breaches and cyber-attacks, which could compromise our intellectual property or other sensitive information, could result in a material disruption of our business or could subject us to regulatory actions that could result in significant fines.
- We, or the third parties upon whom we depend, may be adversely affected by unforeseen or catastrophic events, including the emergence of a pandemic or other natural disasters, and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
- Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and stock price.
- The price of our common stock may be volatile and fluctuate substantially, which could result in substantial losses for purchasers of our common stock.
- We do not intend to pay dividends on our common stock, so any returns will be limited to the value of our stock.
- Our ability to utilize our net operating loss carryforwards and certain other tax attributes has been limited by “ownership changes” and may be further limited.
- We are incurring and will continue to incur significantly increased costs as a result of operating as a public company, and our management is required to devote substantial time to compliance initiatives.
- Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall.
- Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or our guidance.
- In the event that we fail to satisfy any of the listing requirements of the Nasdaq Global Select Market, our common stock may be delisted, which could affect our market price and liquidity.
- If securities analysts do not publish research or reports about our business or if they publish negative evaluations of our stock, the price of our stock could decline.
- Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.
- Our bylaws designate the Court of Chancery of the State of Delaware as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by 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
- For the year ended December 31, 2022, we recognized $82.0 million of license and collaboration revenue under (i) the Gilead asset purchase and license amendment agreement related to the sale of GS-1811 in December 2022 and transfer of certain patents and know-how related to licensed products to Gilead and (ii) the Gilead License Agreement related to the achievement of a clinical development and regulatory milestone. For the year ended December 31, 2021, we recognized $26.9 million of license and collaboration revenue under the Gilead License Agreement related to the achievement of a $25.0 million clinical development and regulatory milestone for FDA clearance of the IND for GS-1811 and $1.9 million related to the completion of research and transition services.