▸ Global economic conditions may have an adverse effect on our business.· · · · ● 1 ▸ group Risks Related to Healthcare Laws and Other Legal Compliance Matters· · · · ● 1 ▸ The Giiant License Agreement pursuant to which we license PALI-2108, and other assets of Giiant, contains certain requirements related to diligence, milestone, royalty, insurance, expense reimbursement, and other obligations. If we· · · · ● 1 ▸ We and the third parties upon which we rely may be subject to a variety of evolving threats, including but not limited to social engineering attacks (including through phishing attacks), malicious code (such as viruses and worms),· · · · ● 1 ▸ We are subject to environmental, health and safety laws and regulations, and we may become exposed to liability and substantial expenses in connection with environmental compliance or remediation activities.· · · · ● 1 ▸ If clinical studies of PALI-2108 do not yield successful results, we may discontinue the development of PALI-2108.· · · ● ● 2 ▸ Even if PALI-2108 is approved for commercialization, future regulatory reviews or inspections may result in its suspension or withdrawal, closure of a facility or substantial fines.· · ● ● ● 3 ▸ If we are unsuccessful in accomplishing these objectives, we may not be able to develop our proposed products, raise capital, expand our business or continue our operations.· · ● ● ● 3 ▸ If we fail to comply with our obligations under our intellectual property license agreements, we could lose license rights that are important to our business.· · ● ● ● 3 ▸ It may take us longer than we estimate to complete clinical trials, and we may not be able to complete them at all.· · ● ● ● 3 rw ▸ Our business depends on the successful clinical development, regulatory approval, and commercialization of our lead asset PALI-2108.· · ● ● ● 3 rw ▸ Our success depends on attracting and retaining senior management and scientists with relevant expertise.· · ● ● ● 3 ▸ PALI-2108 may not have the desired effects or may include undesirable side effects or other characteristics that preclude regulatory approval or limit their commercial use if approved.· · ● ● ● 3 ▸ The successful commercialization of PALI-2108, if approved, will depend in part on the extent to which government authorities and health insurers establish adequate reimbursement levels and pricing policies.· · ● ● ● 3 ▸ There are substantial risks in drug development, and, as a result, we may not be able to successfully develop any product candidate, including our lead clinical product candidate, PALI-2108.· · ● ● ● 3 rw ▸ We face potential product liability exposure, and if successful claims are brought against us, we may incur substantial liability for a product candidate and we may need to limit our commercialization.· · ● ● ● 3 rw ▸ We have a history of net operating losses, and we expect to continue to incur net operating losses and may never achieve profitability.· · ● ● ● 3 rw ▸ We may be subject to patent infringement claims, which could result in substantial costs and liabilities, and could prevent us from commercializing our potential products.· · ● ● ● 3 rw ▸ We may not be able to obtain, maintain or enforce global patent rights or other intellectual property rights that cover our product candidates and technologies that are of sufficient breadth to prevent third parties from competing against us.· · ● ● ● 3 ▸ Our common stock could be delisted from the Nasdaq Stock Market if we are unable to maintain compliance with the Nasdaq Stock Market’s continued listing standards.· ● · ● ● 3 rw ▸ We cannot provide any assurance that we will be able to establish or maintain third-party relationships in order to successfully develop and commercialize our product candidates.· ● ● ● ● 4 rw ▸ We currently rely on third-party contractors to supply, manufacture and distribute clinical drug supplies for our product candidates.· ● ● ● ● 4 rw ▸ We expect that our operations and development of PALI-2108 will require more capital than we currently have, and we cannot guarantee when or if we will be able to secure such additional funding.· ● ● ● ● 4 rw ▸ If we do not achieve one or more of these factors, many of which are beyond our control, in a timely manner or at all, we could experience significant delays or an inability to obtain regulatory approvals or commercialize our· · · ● · 1 ▸ Effectively market any products for which we obtain marketing approval.· · ● · · 1 ▸ Even if our clinical studies are successful and achieve regulatory approval, the approved product label may be more limited than we anticipate, which could limit the commercial prospects of PALI-2108.· · ● · · 1 ▸ If pre-clinical and clinical studies of PALI-2108 do not yield successful results, then we may not continue to develop PALI-2108.· · ● · · 1 ▸ Our management identified a material weakness in our internal control over financial reporting. If we do not remediate this material weakness, or if we identify further material weaknesses in our internal controls, our failure to establish· · ● · · 1 ▸ The Notice states that, consistent with Nasdaq Listing Rule 5605(c)(4), Nasdaq will provide us with a cure period in order to regain compliance (i) until the earlier of the Company’s next annual shareholders’ meeting or March 4, 2025,· · ● · · 1 ▸ Unstable economic and market conditions may have serious adverse consequences on our business, financial condition, and stock price.· · ● ● · 2 ▸ We have entered into a collaborative research agreement with Giiant related to pre-clinical development, which will require the efforts of Giiant and its personnel, which are out of our control.· · ● · · 1 ▸ We may seek to avail ourselves of Fast Track designation, breakthrough designation, or priority review for product candidates it may pursue in the future. For example, if a drug is intended for the treatment of a serious or· · ● · · 1 ▸ Changing circumstances and market conditions, some of which may be beyond our control, could impair our ability to access our existing cash and cash equivalents and investments and to timely pay key vendors and others.· ● ● · · 2 rw ▸ Global, market and economic conditions, including inflation, may negatively impact the Company’s business, financial condition and share price.· ● · · · 1 ▸ If the Company is unable to successfully retain and integrate a new management team, the Company's business could be adversely impacted.· ● · · · 1 ▸ The Company’s product candidates may cause undesirable side effects that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in post-approval regulatory action.· ● · · · 1 ▸ There are no FDA-approved therapies for LB1148’s lead indication which makes it difficult to predict the timing, costs and regulatory approval path of LB1148.· ● · · · 1 ▸ Any adverse developments related to LB1148 that occur during the clinical trials being conducted by Newsoara could affect the Company’s ability to obtain regulatory approval or commercialize LB1148.● ● · · · 2 rw ▸ Changes in tax law could adversely affect the Company’s business.● ● · · · 2 ▸ Healthcare reform measures could hinder or prevent the commercial success of the Company’s product candidates.● · · · · 1 ▸ If the Company fails to attract and retain management and other key personnel, it may be unable to successfully develop or commercialize its product candidates or otherwise implement its business plan.● ● · · · 2 ▸ If the Company is not able to comply with the applicable continued listing requirements or standards of The Nasdaq Capital Market, Nasdaq could delist its common stock.● · · · · 1 ▸ If the Company is sued for infringing intellectual property rights of third parties, such litigation could be costly and time consuming and could prevent or delay it from developing or commercializing its product candidates.● ● · · · 2 ▸ In order to conduct larger or late-stage clinical trials for a product candidate and supply sufficient commercial quantities of the resulting drug product and its components, if that product candidate is approved for sale, the● · · · · 1 ▸ Our business could be negatively affected as a result of the actions of activist stockholders, and such activism could impact the trading value of our securities.● ● ● · · 3 rw ▸ Securities class action litigation could divert our management’s attention and harm our business and could subject us to significant liabilities.● ● ● · · 3 ▸ Supply chain constraints associated with the COVID-19 pandemic have impacted the availability of the components needed in the manufacture of LB1148 and, depending on the duration and extent of the pandemic or new strains, could● · · · · 1 ▸ The Company currently has no products approved for sale, and it may never obtain regulatory approval to commercialize any of its product candidates.● ● · · · 2 ▸ The Company may also be subject to stricter healthcare laws, regulation and enforcement, and its failure to comply with those laws could adversely affect its business, operations and financial condition.● ● · · · 2 ▸ The Company may be subject to risks related to off-label use of its product candidates.● ● · · · 2 ▸ The Company may expend its limited resources to pursue a particular indication and fail to capitalize on indications that may be more profitable or for which there is a greater likelihood of success.● ● · · · 2 ▸ The Company may face product liability exposure, and if successful claims are brought against it, the Company may incur substantial liability if its insurance coverage for those claims is inadequate.● ● · · · 2 ▸ The Company will incur costs and demands upon management as a result of complying with the laws and regulations affecting public companies.● · · · · 1 ▸ The Company’s ability and its partners’ ability to establish and enforce intellectual property rights in and to LB1148.● · · · · 1 ▸ The Company’s ability to use NOL carryforwards and certain other tax attributes may be limited.● ● · · · 2 ▸ The Company’s business depends on the successful clinical development, regulatory approval and commercialization of LB1148.● ● · · · 2 ▸ The Company’s product candidates, if approved, may face significant competition and their failure to compete effectively may prevent them from achieving significant market penetration.● ● · · · 2 rw ▸ The occurrence of any of the foregoing could adversely affect the Company’s business, financial condition or operating results.● ● · · · 2 ▸ The results of previous clinical trials may not be predictive of future results, and the results of the Company’s current and planned clinical trials may not satisfy the requirements of the FDA or non-U.S. regulatory authorities.● ● · · · 2 ▸ We have expressed substantial doubt about our ability to continue as a going concern.● ● ● ● · 4 rw ▸ We may find it difficult to enroll patients in our clinical trials, which could delay or prevent us from proceeding with clinical trials of our product candidates.● · · ● ● 3 rw ▸ Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition of us more difficult and may prevent attempts by our stockholders to replace or remove our management.● ● ● ● ● 5 rw ▸ Clinical drug development is expensive, time-consuming and uncertain.● ● ● ● ● 5 rw ▸ Even if a product candidate obtains regulatory approval, it may fail to achieve the broad degree of physician and patient adoption and use necessary for commercial success.● ● ● ● ● 5 ▸ Failure to remediate a material weakness in internal controls over financial reporting could result in material misstatements in our consolidated financial statements.● ● ● ● ● 5 rw ▸ Future sales of substantial amounts of our common stock, or the possibility that such sales could occur, could adversely affect the market price of our common stock.● ● ● ● ● 5 ▸ If equity research analysts do not publish research or reports, or publish unfavorable research or reports, about us, our business or our market, our stock price and trading volume could decline.● ● ● ● ● 5 rw ▸ If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired.● ● ● ● ● 5 rw ▸ group Other Risks Related to Our Securities● ● ● ● ● 5 rw ▸ Our Board has broad discretion to issue additional securities, which might dilute the net tangible book value per share of our common stock for existing stockholders.● ● ● ● ● 5 rw ▸ Our business and operations would suffer in the event of system failures, cyber-attacks or a deficiency in our cybersecurity.● ● ● ● ● 5 rw ▸ Our common stock price may be highly volatile.● ● ● ● ● 5 rw ▸ Our inability to successfully in-license, acquire, develop and market additional product candidates or approved products could impair our ability to grow our business.● ● ● ● ● 5 rw ▸ group Risks Related to Our Business● ● ● ● ● 5 rw ▸ group Risks Related to Our Dependence on Third Parties● ● ● ● ● 5 rw ▸ Risks Related to Our Development, Commercialization and Regulatory Approval of Our Product Candidates● ● ● ● ● 5 rw ▸ group Risks Related to Our Financial Operations● ● ● ● ● 5 rw ▸ group Risks Related to Our Intellectual Property● ● ● ● ● 5 rw ▸ We are currently conducting a Phase 1 clinical trial of PALI-2108 in Canada, and the FDA or applicable foreign regulatory authorities may not accept data from such trials, or any other trial we conduct outside of the U.S.● ● ● ● ● 5 rw ▸ We do not anticipate paying any dividends in the foreseeable future.● ● ● ● ● 5 rw ▸ We expect to rely on collaborations with third parties for the successful development and commercialization of our product candidates.● ● ● ● ● 5 rw ▸ We have a limited operating history and have never generated any revenues from product sales.● ● ● ● ● 5 rw ▸ We may be subject to claims that our officers, directors, employees, consultants or independent contractors have wrongfully used or disclosed to us alleged trade secrets of their former employers or their former or current customers.● ● ● ● ● 5 rw ▸ We may not be able to protect our intellectual property rights throughout the world.● ● ● ● ● 5 rw ▸ We take advantage of reduced disclosure and governance requirements applicable to smaller reporting companies, which could result in our common stock being less attractive to investors.● ● ● ● ● 5 rw ▸ We will need to raise additional financing in the future to fund our operations, which may not be available to us on favorable terms or at all.● ● ● ● ● 5 rw 
