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New words:
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Removed:
aberrant, aberrantly, Ablation, accepting, accurately, achievement, activate, addressable, adjacent, afford, aforementioned, age, aggressive, alliance, allocate, allocating, Antitumor, aspect, assemble, asserted, assumed, AST, attract, automatic, background, big, Blockade, bone, breast, Budget, capable, capitalize, central, checkpoint, chromatin, collaborative, combining, commonly, community, comparison, complement, conformational, continuum, convenience, discontinue, disproportionate, disrupting, domestically, driver, ease, educate, escalation, ESPP, Expanding, extensively, fate, fill, fluctuate, forego, frequent, granting, grow, Histone, history, immune, Immunity, incentivizing, influence, inherent, integrating, intense, international, invest, jeopardize, Johnson, joint, landscape, launched, leading, leave, legally, line, list, lysine, maintenance, Majello, managerial, managing, matching, median, medically, modification, mono, motivate, motivating, mutual, negligence, newly, Obama, obsolete, originally, pandemic, phenotype, prefer, prevalence, prevented, productivity, proliferation, PRV, pursuit, Qin, quickly, real, recognition, recognizing, regimen, relapsed, render, resolved, secure, sensitize, sequence, Sheng, shortage, silence, Simplifying, skill, skilled, solved, sparked, specialty, speculative, stay, stem, streamline, subsidize, succeed, suitable, supportive, sustain, tangible, targeting, telephone, thought, trend, trillion, unavailable, underwriting, unmarketable, unsuitable, untreated, usage, versa, vice, warn
Financial report summary
?Risks
- We do not currently have sufficient working capital to fund our planned operations for the next twelve months and may not be able to continue as a going concern. There is uncertainty regarding our ability to maintain liquidity sufficient to operate our business, which raises substantial doubt about our ability to continue as a going concern.
- We have never generated any revenue from product sales and may never generate revenue or be profitable.
- The approach we have taken to discover and develop novel oncology therapeutics using epigenetic enzymes to moderate transcription factors and thereby control abnormal protein expression is unproven and may never lead to marketable products.
- Clinical trials are costly, time consuming and inherently risky, and may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities.
- Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial viability of an approved label, or result in significant negative consequences following marketing approval, if any.
- Some of our product candidates may produce results in pre-clinical or clinical settings for indications other than those for which we contemplate conducting development activities or seeking FDA approval, and we cannot give any assurance that our clinical trials will generate data for any of our product candidates sufficient to receive regulatory approval in our planned indications, which will be required before they can be commercialized.
- Product development involves a lengthy and expensive process with an uncertain outcome, and results of earlier pre-clinical and clinical trials may not be predictive of future clinical trial results.
- Difficulty in enrolling patients is a common hurdle faced by early stage biotechnology companies and could, and often does, delay or prevent clinical trials of product candidates.
- We may face potential product liability, and, if successful claims are brought against us, we may incur substantial liability and costs which could be greater than our insurance coverage or overall resources. If the use or misuse of our product candidates harms patients, or is perceived to harm patients even when such harm is unrelated to our product candidates, our regulatory approvals, if any, could be revoked or otherwise negatively impacted and we could be subject to costly and damaging product liability claims. If we are unable to obtain adequate insurance or are required to pay for liabilities resulting from a claim excluded from, or beyond the limits of, our insurance coverage, a material liability claim could adversely affect our financial condition.
- Even if FDA grants breakthrough therapy designation for one or more of our product candidates, the designation may not lead to a faster development or regulatory review or approval process, and it does not increase the likelihood that our product candidates will receive marketing approval, and FDA may rescind the designation if it determines the product candidate no longer meets the qualifying criteria for breakthrough therapy.
- We have received Fast Track designation for one of our product candidates, but such designation may not actually lead to a faster development or regulatory review or approval process. Additionally, FDA may rescind the designation if it determines the product candidate no longer meets the qualifying criteria for Fast Track.
- We cannot guarantee how long it will take regulatory agencies to review our applications for product candidates, and we may fail to obtain the necessary regulatory approvals to market our product candidates. If we are not able to obtain required regulatory approvals, we will not be able to commercialize our product candidates and our ability to generate revenue will be materially impaired.
- Even if we obtain regulatory approval for a product, we will remain subject to ongoing regulatory requirements, which may result in significant additional expense and other restrictions, and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates.
- Healthcare reform measures may have a material adverse effect on our business, financial condition or results of operations.
- We may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws, and health information privacy and security laws. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.
- Reliance on government funding for our programs may add uncertainty to our research and commercialization efforts with respect to those programs that are tied to such funding and may impose requirements that limit our ability to take specified actions, increase the costs of commercialization and production of product candidates developed under those programs and subject us to potential financial penalties, which could materially and adversely affect our business, financial condition and results of operations.
- If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs and liabilities that could have a material adverse effect on our business, financial condition or results of operations.
- We may not be successful in obtaining or maintaining necessary rights to our targets, product compounds and processes for our development pipeline through acquisitions and in-licenses.
- We intend to rely on patent rights for our product candidates and any future product candidates. If we are unable to obtain or maintain exclusivity from the combination of these approaches, we may not be able to compete effectively in our markets.
- We may not have sufficient patent term protections for our product candidates to effectively protect our business.
- Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products, and 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
- If we are unable to maintain effective proprietary rights for our product candidates or any future product candidates, we may not be able to compete effectively in our proposed markets.
- Third-party claims of intellectual property infringement may prevent or delay our development and commercialization efforts.
- We may not be successful in meeting our obligations under our existing license agreements necessary to maintain our product candidate licenses in effect. In addition, if required in order to commercialize our product candidates, we may be unsuccessful in obtaining or maintaining necessary rights to our product candidates through acquisitions and in-licenses.
- The patent protection and patent prosecution for some of our product candidates is dependent on third parties.
- If we fail to comply with obligations in the agreements under which we licenses intellectual property and other rights from third parties or otherwise experience disruptions to our business relationships with our 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.
- 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 not be able to protect our intellectual property rights throughout the world.
- We rely on or will rely on third parties to conduct our clinical trials. If these third parties do not successfully perform and comply with regulatory requirements, we may not be able to successfully complete clinical development, obtain regulatory approval or eventually commercialize our product candidates and our business could be substantially harmed.
- We expect to rely on third parties to manufacture our clinical product supplies, and we intend to rely on third parties to produce and process our product candidates, if approved, and our commercialization of any of our product candidates could be stopped, delayed or made less profitable if those third parties fail to obtain approval of government regulators, fail to comply with applicable regulations, fail to provide us with sufficient quantities of drug product, or fail to do so at acceptable quality levels or prices.
- We may be unable to realize the potential benefits of any current or future collaboration.
- Future sales of a significant number of our shares of common stock in the public markets, or the perception that such sales could occur, could depress the market price of our shares of our common stock or cause our stock price to decline.
- We do not currently intend to pay dividends on our common stock, and any return to investors is expected to come, if at all, only from potential increases in the price of our common stock.
- Failure in our information technology and storage systems could significantly disrupt the operation of our business and/or lead to potential large liabilities.
Management Discussion
- Research and development expenses were $7.2 million during the year ended December 31, 2023 compared to $15.8 million during the year ended December 31, 2022. This decrease of $8.7 million principally resulted from the cost savings plan implemented during the third quarter and lower spending on SP-2577. The acquisition of SP-3164 technology for $2.0 million occurred in 2022 did not repeat in 2023. Lower research and development expenses will continue in 2024 as we have curtailed our sponsored clinical trials and intend to rely on clinical trial data from the investigator initiated clinical trial conducted by MD Anderson Cancer Center in connection with our strategic alternatives review process.