Unicycive Therapeutics, Inc. 10-K

ITEM 9A. CONTROLS AND PROCEDURES Evaluation of Disclosure Controls Our principal executive officer and principal financial officer evaluated the effectiveness of our “disclosure controls and procedures” as of December 31, 2021, the end of the period covered by this Annual Report on Form 10-K. The term “disclosure controls and procedures” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files under the Exchange Act is accumulated and communicated to a company’s management, including its principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, cannot provide absolute assurance that the objectives of the controls system are met, and no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within a company have been detected. Based on the evaluation of our disclosure controls and procedures as of December 31, 2021, our Chief Executive Officer and our Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were not effective as we did not design or maintain an effective control environment commensurate with the financial reporting requirements. Specifically, we lack a sufficient number of professionals with an appropriate level of accounting knowledge, training and experience to appropriately analyze, record and disclose accounting matters timely and accurately while maintaining appropriate segregation of duties. Without such professionals, we did not design and maintain formal accounting policies, procedures and controls to achieve complete, accurate and timely financial accounting, reporting and disclosures, including controls over the preparation and review of account reconciliations and journal entries. The lack of adequate staffing levels resulted in insufficient time spent on review and approval of certain information used to prepare our financial statements and the maintenance of effective controls to adequately monitor and review significant transactions for financial statement completeness and accuracy. These control deficiencies, although varying in severity, contributed to the material weakness in the control environment. If one or more material weaknesses persist or if we fail to establish and maintain effective internal control over financial reporting, our ability to accurately report our financial results could be adversely affected. The above material weakness did not result in a material misstatement of our previously issued financial statements, however, it could result in a misstatement of our account balances or disclosures that would result in a material misstatement of our annual or interim financial statements that would not be prevented or detected. Management is taking steps to remediate the material weakness in our internal control over financial reporting. To address the issues, we plan to hire additional personnel. Specifically, management will: ● Increase the number of accounting personnel; ● Begin discussions with third party experts to assist management in completing a comprehensive risk assessment to identify, design and implement control activities; and ● Begin reviewing and enhancing business policies, procedures and related internal controls to standardize business processes. We expect to complete the remediation by the end of 2022. We expect to incur additional costs to remediate this weakness, primarily personnel costs. - 60 - Management’s Report on Internal Control Over Financial Reporting Our management is responsible for establishing and maintaining adequate internal control over financial reporting as such term is defined in Exchange Act Rule 13a-15(f). Internal control over financial reporting is a process designed under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with U.S. GAAP. All internal control systems, no matter how well designed, have inherent limitations. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation. As of December 31, 2021, under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting based on the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control-Integrated Framework - 2013. Based on this assessment, our management concluded that, as of December 31, 2021, our internal control over financial reporting was not effective due to a material weakness in our internal control over financial reporting as discussed above in our evaluation of disclosure controls. The lack of adequate staffing levels resulted in insufficient time spent on review and approval of certain information used to prepare our financial statements and the maintenance of effective controls to adequately monitor and review significant transactions for financial statement completeness and accuracy. These control deficiencies, although varying in severity, contributed to the material weakness in the control environment. If one or more material weaknesses persist or if we fail to establish and maintain effective internal control over financial reporting, our ability to accurately report our financial results could be adversely affected. In light of the material weakness, we performed additional analysis and other post-closing procedures to ensure the reliability of financial reporting and that our financial statements were prepared in accordance with U.S. GAAP. Accordingly, we believe that the financial statements included in this report fairly present, in all material respects, our financial condition, results of operations and cash flows for the periods presented. Management is taking steps to remediate the material weakness in our internal control over financial reporting. To address the issues, we plan to hire additional personnel. Specifically, management will: ● Increase the number of accounting personnel; ● Begin discussions with third party experts to assist management in completing a comprehensive risk assessment to identify, design and implement control activities; and ● Begin reviewing and enhancing business policies, procedures and related internal controls to standardize business processes. We expect to complete the remediation by the end of 2022. We expect to incur additional costs to remediate this weakness, primarily personnel costs. This Annual Report on Form 10-K does not include an attestation report of our registered public accounting firm regarding internal control over financial reporting. Management’s report was not subject to attestation by the Company’s registered public accounting firm pursuant to the exemption provided to issuers that are not “large accelerated filers” nor “accelerated filers” under the Dodd-Frank Wall Street Reform and Consumer Protection Act. Changes in Internal Control Over Financial Reporting There have been no changes in our internal control over financial reporting that occurred during our last fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. ITEM 9B. OTHER INFORMATION None. ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS. Not applicable. - 61 - PART III ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE The following table sets forth the name, age and positions of our executive officers and directors as of March 31, 2022: Name Age Position Shalabh Gupta, M.D. 48 Chief Executive Officer, President and Chairman of the Board of Directors Pramod Gupta, Ph.D. 62 Executive Vice President, Pharmaceutical and Business Operations John Townsend 60 Chief Financial Officer John Ryan, M.D., Ph.D. 78 Director Sandeep Laumas, M.D. 53 Director Brigitte Schiller, M.D. (1) 61 Director The business background and certain other information about our directors and executive officers is set forth below. Shalabh Gupta, M.D. Shalabh Gupta, our founder, has served as our Chief Executive Officer, President and director since August 2016. Since June 2013, Dr. Gupta has also served as the founder and Chief Executive Officer of Globavir Biosciences, Inc., a company focused on commercializing novel therapeutics and powerful diagnostics for treating global infectious disease. Dr. Gupta has also served in various other capacities including founder and Chief Executive Officer of Biocycive Inc.; Strategy, Genentech Commercial at Genentech, Inc.; Equity Research, Pharmaceuticals at UBS Investment Bank; Attending Physician at NYU Medical Center; clinical faculty member at NYU School of Medicine; and Equity Research, Biotechnology at Rodman & Renshaw, LLC. In addition, he has served on the board of directors of Beall Center for Innovation and Entrepreneurship since 2018. Dr. Gupta has also served as an advisor to SPARK, Stanford University School of Medicine since 2012, a charter member of TiE, a not-for-profit network of entrepreneurs fostering entrepreneurship, mentoring and education, since 2013. Dr. Gupta previously served on the board of directors of Phenomenome Discoveries Inc. and was a Fellow at the Startup Leadership Program, a medical advisor Synageva BioPharma Corporation (formerly known as AviGenics) and an advisor to NYU Langone Medical Center (Office of Technology Transfer). Dr. Gupta received his MPA in health care finance and management from NYU Robert F. Wagner Graduate School of Public Service, and his medical degree from Jawaharlal Institute of Postgraduate Medical Education & Research, India. Furthermore, Dr. Gupta completed his internship in Internal Medicine, and medical residency in physical medicine and rehabilitation and a research fellowship in cardiopulmonary rehabilitation from New York University (“NYU”) School of Medicine and New York University. He practiced medicine from 2000 to 2008 at NYU’s various hospitals first during his medical training (2000-2004) and then as an attending physician (2004-2008). Dr. Gupta also served as a faculty member at NYU School of Medicine. In the past, Dr. Gupta was a board-certified physician, and he currently holds a license from the California State Medical Board. While working as a stock analyst on Wall Street, Dr. Gupta held Series 7, 63, 86 and 87 licenses. We believe Dr. Gupta is qualified to serve as a member of our board of directors because of his background as a physician and as a biotechnology executive and his extensive experience in both in-licensing technologies from academic institutions and biotechnology companies as well as out-licensing technologies to larger organizations in addition to his former experience on Wall Street. - 62 - Pramod Gupta, Ph.D. Dr. Gupta has served as our Executive Vice President, Pharmaceutical and Business Operations since September 2020. Dr. Gupta is a pharmaceutical executive with 30 years’ experience at large as well as small companies. He has extensive experience in drug development, regulatory requirements and drug approvals globally. He has led development/approval/launch of over 40 products by leveraging external partnerships/technologies/business solutions. Previously Dr. Gupta served as the Senior Vice President at Spectrum Pharmaceuticals from January 2011 to April 2018, Vice President at Bausch & Lomb from May 2005 to August 2009, and at positions of increasing responsibilities at Baxter, TAP Pharmaceuticals and Abbott Laboratories. He has published more than 50 scientific papers and 2 scientific books, and holds 14 patents. He completed his PhD from the University of Otago New Zealand. John Townsend. Mr. Townsend has served as our Chief Financial Officer starting in March 2021, and he has previously served as Vice President Finance and Chief Accounting Officer in a consulting role since September 2020. He has over 25 years of public and private company experience in industries including biotechnology, medical devices, and high-tech electronics manufacturing. Before joining the Company, Mr. Townsend worked at Guardion Health Sciences, a medical foods company from 2016 to 2020. From 2005 until 2015, he worked at Cytori Therapeutics, Inc., a stem cell therapy company. From 1996 to 2005, he worked at several high-tech companies, and he started his career at Deloitte (formerly Deloitte and Touche) after graduating from San Diego State University in 1993. Mr. Townsend is a Certified Public Accountant in the state of California. John Ryan, M.D., Ph.D. John Ryan has served as our director since 2018. Since 2011, Dr. Ryan has served as Executive Vice President, Chief Medical Officer of Kadmon Holdings, Inc., a biopharmaceutical company engaged in the discovery, development and commercialization of small molecules and biologics. From 2009 until 2011, Dr. Ryan served as Senior Vice President and Chief Medical Officer of Cerulean Pharma, Inc., a publicly traded pharmaceutical company, and from 2006 until 2009, he served as Chief Medical Officer at Aveo Pharmaceuticals, Inc. (Nasdaq: AVEO), a biopharmaceutical company seeking to advance targeted medicines for oncology and other unmet medical needs. From 1995 until 2006, Dr. Ryan served as Senior Vice President of Translational Research at Wyeth (formerly Genetics Institute), where he served as head of the Department of Experimental Medicine. Dr. Ryan also served as an Executive Director of Clinical Research at Merck Research Laboratories from 1989 to 1995 and he previously served on the scientific advisory boards of ArQule, Inc. and Expression Analysis, Inc. Dr. Ryan has also been a director of Globavir Biosciences, Inc. since 2014. Dr. Ryan received his B.S. and his Ph.D. from Yale University. Dr. Ryan received his M.D. from the University of California, San Diego. We believe Dr. Ryan is qualified to serve as a member of our board of directors because of his clinical background and extensive experience in running clinical development programs and getting drugs through the FDA approval process. - 63 - Sandeep Laumas, M.D. Sandeep Laumas has served as our director since 2018. Since 2014, Dr. Laumas has served on the board of directors of private and publicly traded biotechnology companies. In 2008, Dr. Laumas founded Bearing Circle Capital, an investment vehicle and has served as its Managing Director since such time. Dr. Laumas began his career at Goldman Sachs & Co. in 1996 as an equity analyst in the healthcare investment banking division working on mergers & acquisitions and corporate finance transactions before transitioning to the healthcare equity research division. After leaving Goldman Sachs in 2000, Dr. Laumas moved to the buy side as an analyst at Balyasny Asset Management from 2001 to 2003. Dr. Laumas was a Managing Director of North Sound Capital from 2003 to 2007, where he was responsible for the global healthcare investment portfolio. Dr. Laumas has served as a member of the board of directors of private and public healthcare companies including, Parkway Holdings Ltd. (2010), SRL Ltd. (2011-2012), 9 Meters Biopharma, Inc. (2018-present) and BioXcel Therapeutics, Inc. (2017-present). Dr. Laumas has also been a director of Globavir Biosciences, Inc. since 2015. Dr. Laumas received his A.B. in Chemistry from Cornell University in 1990, M.D. from Albany Medical College in 1995 with a research year at the Dana-Farber Cancer Institute and completed his medical internship in 1996 from the Yale University School of Medicine. We believe Dr. Laumas is qualified to serve as a member of our board of directors because his vast industry perspective in both public and private investments and financial transactions in the healthcare arena. Brigitte Schiller, M.D., FACP, FASN. Dr. Schiller has served as our director since 2020. Dr. Schiller has been Chief Medical Officer at Satellite Healthcare since 2010. In this role, Dr. Schiller is responsible for Quality, Physician Leadership and Research & Development. She oversees the development and implementation of the quality strategy, its execution and organizational infrastructure. Dr. Schiller serves as Chief of Staff, and as such provides oversight on more than 80 medical directors and over 400 referring physicians. As CMO Dr. Schiller is responsible for the delivery of care to more than 8,000 dialysis patients in 80 US centers. She directs Satellite’s clinical research efforts, which by deliberate policy are applied pragmatic real-world studies directed towards improvement in patient experience and outcomes. Under her leadership, Satellite Healthcare has achieved the highest quality ratings in the CMS 5 Star Ratings for several years. Dr. Schiller has participated as investigator in multiple FDA trials, including pivotal drug and device trials in ESRD care over the past 15 years. She is a published author in many areas of ESRD care, including home dialysis. She is known as an inspirational leader who is determined to transform the care of patients with chronic kidney disease through quality improvement efforts, innovative drugs and devices as well as alternative care models unchanged since 1973. She has been a consultant to various early-stage and established healthcare companies. Dr. Schiller serves as an Adjunct Lecturer in the Division of Nephrology at Stanford University. She is a frequent invited speaker at national and international meetings. She has received teaching and research awards including the 2017 Woman of Influence award for executives. She serves on the Expert Panel for the USRDS database. Dr. Schiller graduated MD summa cum laude from the University of Freiburg, Germany and, in addition to postgraduate training at the University of Munich, completed residency and research fellowships at Rush-Presbyterian-St. Luke’s Medical Center, Chicago, Northwestern University and the University of Chicago. Chief Development Advisor Keith Ward, Ph.D. Dr. Ward is a life sciences executive with over 25 years of experience in the biotech and pharmaceutical industry. In addition to his role at Unicycive, Dr. Ward serves in leadership and Board positions for several emerging biotech and pharma companies. Prior to joining Unicycive in an advisory capacity, Dr. Ward served as Executive Vice President and Chief Development Officer for Reata Pharmaceuticals, from July 2011 through March 2019 and led research and development, clinical operations, regulatory affairs, manufacturing, and project management. Before that, Dr. Ward developed ophthalmic pharmaceuticals and medical devices as Global Vice President of Pharmaceutical R&D for Bausch & Lomb from May, 2005 to June, 2011. Dr. Ward has also held positions of increasing responsibility within GlaxoSmithKline and SmithKline Beecham Pharmaceuticals. Dr. Ward earned a B.S. in Toxicology with a minor in Chemistry from Northeast Louisiana University and a Ph.D. in Toxicology from The University of North Carolina at Chapel Hill. Family Relationships There are no family relationships among any of our executive officers or directors. Arrangements between Officers and Directors Except as set forth in this Annual Report on Form 10-K, to our knowledge, there is no arrangement or understanding between any of our officers or directors and any other person pursuant to which such officer or director was selected to serve as an officer or director of the Company. - 64 - Involvement in Certain Legal Proceedings We are not aware of any of our directors or officers being involved in any legal proceedings in the past ten years relating to any matters in bankruptcy, insolvency, criminal proceedings (other than traffic and other minor offenses), or being subject to any of the items set forth under Item 401(f) of Regulation S-K. Committees of Our Board of Directors Our board of directors directs the management of our business and affairs, as provided by Delaware law, and conducts its business through meetings of the board of directors and its standing committees. We have a standing audit committee, compensation committee and corporate governance and nominating committee. In addition, from time to time, special committees may be established under the direction of the board of directors when necessary to address specific issues. Audit Committee Our audit committee is responsible for, among other things: ● approving and retaining the independent auditors to conduct the annual audit of our financial statements; ● reviewing the proposed scope and results of the audit; ● reviewing and pre-approving audit and non-audit fees and services; ● reviewing accounting and financial controls with the independent auditors and our financial and accounting staff; ● reviewing and approving transactions between us and our directors, officers and affiliates; ● establishing procedures for complaints received by us regarding accounting matters; ● overseeing internal audit functions, if any; and ● preparing the report of the audit committee that the rules of the SEC require to be included in our annual meeting proxy statement. Our audit committee consists of Dr. Laumas, Dr. Ryan, and Dr. Schiller, with Dr. Laumas serving as chair. Our board of directors has affirmatively determined that each meets the definition of “independent director” under the Nasdaq rules, and that they meet the independence standards under Rule 10A-3. Each member of our audit committee meets the financial literacy requirements of the Nasdaq rules. In addition, our board of directors has determined that Dr. Laumas qualifies as an “audit committee financial expert,” as such term is defined in Item 407(d)(5) of Regulation S-K. Our board of directors has adopted a written charter for the audit committee, which is available on our principal corporate website at http://www.unicycive.com . Compensation Committee Our compensation committee is responsible for, among other things: ● reviewing and recommending the compensation arrangements for management, including the compensation for our chief executive officer; ● establishing and reviewing general compensation policies with the objective to attract and retain superior talent, to reward individual performance and to achieve our financial goals; ● administering our stock incentive plans; and ● preparing the report of the compensation committee that the rules of the SEC require to be included in our annual meeting proxy statement. - 65 - Our compensation committee consists of Dr. John Ryan and Dr. Sandeep Laumas, with John Ryan serving as chair. Our board has determined that the committee members are independent directors under Nasdaq rules. Our board of directors has adopted a written charter for the compensation committee, which is available on our principal corporate website at http://www.unicycive.com . Nominating and Governance Committee Our nominating and governance committee is responsible for, among other things: ● identifying and nominating members of the board of directors; ● developing and recommending to the board of directors a set of corporate governance principles applicable to our Company; and ● overseeing the evaluation of our board of directors. Our nominating and corporate governance committee consists of Dr. Schiller and Dr. Ryan, with Dr. Schiller serving as chair. Our board has determined that the committee members are independent directors under Nasdaq rules. Our board of directors has adopted a written charter for the nominating and governance committee, which is available on our principal corporate website at http://www.unicycive.com . Scientific Advisory Board Ravi Mehta, M.D. Dr. Mehta is a Professor Emeritus of Medicine in the Department of Medicine at University of California San Diego where he directs the UCSD Masters in Clinical Research Program. He is an internationally recognized expert in the field of acute kidney injury (AKI) and continuous renal replacement therapies (CRRT). He holds a patent for “Continuous Hemodialysis Using Citrate”. He chairs the annual International AKI and CRRT Conference in San Diego that is now in its 25th year. He chaired the International Society of Nephrology (ISN) Committee on AKI, is a founding member of the Acute Dialysis Quality Initiative (ADQI) and the Acute Kidney Injury network (AKIN), a member of the KDIGO Guidelines in AKI committee and served as the director of the ISN 0 by 25 initiative to eliminate preventable deaths from AKI by 2025. He has coordinated and led several multinational efforts for determining best approaches for managing AKI and CRRT. These have included the IHD vs CRRT trial, The PICARD network, the DIRECT study evaluating the genetic determinants of drug induced nephrotoxicity and the ISN 0by25 initiative. He has more than 200 original research publications, 100 reviews and book chapters. He has served on the NIH NIDDK study section and special emphasis panels and on editorial boards of the Journal of American Society of Nephrology, Kidney International and CJASN. He has been on the program committee of the ISN and contributed to the annual meetings of the American Society of Nephrology, National kidney Foundation and ISICEM. He has coordinated the development of consensus recommendations including the RIFLE and AKIN diagnostic and staging criteria for AKI. He has been recognized as one of the Best Doctors in San Diego and the US for several years. In 2008 he was recognized by the American Nephrologists of Indian Origin and in March 2009 he was elected as a Fellow of the Royal College of Physicians in the UK. He received the International Society of Nephrology (ISN) Bywaters Award for lifetime achievement in AKI in April 2011. He received the M.B.B.S. degree (1976) from the Government Medical School in Amritsar, India, and the M.D. (1979) and D.M. (1981) degrees from the Post Graduate Institute of Medical Education and Research in Chandigarh, India. He subsequently completed a nephrology fellowship at the University of Rochester in Rochester New York and obtained his boards in Internal Medicine (1986) and Nephrology (1988). He has been on the faculty at San Diego since 1988. - 66 - Myles Wolf, MD, MMSc. Dr. Wolf is Charles Johnson, MD, Professor of Medicine and Chief of the Division of Nephrology at the Duke University School of Medicine. Dr. Wolf received his MD from the State University of New York–Downstate, completed Internal Medicine and Nephrology training at the Massachusetts General Hospital, and obtained a Master of Medical Sciences degree in Clinical and Physiological Investigation from Harvard Medical School. After serving on the Harvard faculty for 5 years, Dr. Wolf moved to the University of Miami Miller School of Medicine, where he eventually served as Chief of the Division of Nephrology and Hypertension, Director of the Clinical Research Center, and Assistant Dean for Translational and Clinical Research. Subsequently, he spent 3 years at Northwestern University Feinberg School of Medicine as founding Director of the Center for Translational Metabolism and Health and as Director of the Department of Medicine’s Physician-Scientist Training Program. Dr. Wolf moved to Duke in 2013. As Chief of Duke Nephrology, Dr. Wolf mentors, manages and leads >40 clinical and research faculty, >12 nephrology fellows, 5 advanced practice practitioners, an administrative and research staff of >30 professionals, and many rotating students and postdoctoral PhD trainees. Managing an annual operating budget of more than $15M, Dr. Wolf is responsible for developing the vision and executing the operational strategy of Duke Nephrology across its clinical, research and educational missions. The focus of Dr. Wolf’s clinical trials, patient-oriented, epidemiological, and laboratory research is disordered mineral metabolism across the spectrum of kidney disease from early stages to end-stage renal disease and following kidney transplantation. His primary contributions have been to characterize the central role of fibroblast growth factor 23 in phosphate and calcium homeostasis in health and in disease, and the deleterious effects of excess fibroblast growth factor 23 that increase risks of cardiovascular disease and death. Since 2002, Dr. Wolf’s research has been supported by the American Heart Association, National Kidney Foundation, American Society of Nephrology, and National Institutes of Health. As Principal Investigator, he has been the recipient of more than $25 million of extramural grant support throughout his career. Having served on Steering Committees and as Principal Investigator of multiple industry- and federally-sponsored clinical trials, Dr. Wolf is currently PI of “HiLo,” which is a randomized multicenter pragmatic clinical outcomes trial of phosphate management in patients with end-stage renal disease. Dr. Wolf has published his research in N Engl J Med, JAMA, J Clin Invest, Circulation, Cell Metabol, J Am Soc Nephrol, and Kidney Int, among others. Dr. Wolf has been primary research mentor for students, residents, fellows, and faculty, many of whom are now independent investigators and national leaders in academic nephrology. He has served on editorial boards for J Am Soc Nephrol, Clin J Am Soc Nephrol, Semin Nephrol , and Nat Rev Nephrol , as an ad hoc reviewer for several other journals, and as Editor of the Mineral Metabolism section of Curr Opin Nephrol Hypertens . Dr. Wolf has delivered numerous invited lectures on his research domestically and internationally, and has received several teaching, mentoring and research awards. In recognition of his scientific contributions, Dr. Wolf was elected to the American Society of Clinical Investigation in 2010 and the Association of American Physicians in 2017. He received the 2014 Young Investigator Award from the American Society of Nephrology, and was elected to the Council of the International Society of Nephrology in 2017 and as Chair of its North American and Caribbean Regional Board in 2019. In 2020, Dr. Wolf was appointed to the Board of Directors of Akebia Therapeutics, Inc. Pablo Pergola, MD, PhD Dr. Pergola, MD, Ph.D. is the research director of the Clinical Advancement Center, PLLC, and a member of Renal Associates PA, a large nephrology practice serving patients in San Antonio, Texas and surroundings. He joined the practice in 2005 after working as an Assistant Professor of Medicine, UT Health San Antonio and the Audie L. Murphy VA Hospital in San Antonio for 6 years. Dr. Pergola leads a talented and dedicated group of professionals with the common goal of serving patients with kidney disease through advancements in science and medicine. Dr. Pergola maintains a busy practice while dedicating significant effort to conducting clinical studies. He sees patients in the outpatient clinics, dialysis units and hospitals. Dr. Pergola is fluent in English and Spanish. He is board-certified in Nephrology. He remains academically very active; he is an author in numerous publications and abstract presentations at national and international meetings. He is also a consultant for several pharmaceutical companies that value his experience in protocol development and mechanisms of kidney disease. Dr. Pergola studied Medicine in Buenos Aires, Argentina, at the School of Medicine, Universidad del Salvador. He then received his PhD in Pharmacology, graduating with honors from the University of Kansas Medical Center, Kansas City. After obtaining additional post-doctoral training in basic and clinical research in the Department of Physiology, UT Health San Antonio, he completed his Internal Medicine internship and residency and Nephrology fellowship at UT Health San Antonio. - 67 - Glenn Chertow, MD, MPH Dr. Chertow, MD, MPH is the Norman S. Coplon Satellite Healthcare Professor of Medicine and (by courtesy) of Epidemiology and Population Health, and Chief, Division of Nephrology at Stanford University School of Medicine. Dr. Chertow completed his undergraduate education at University of Pennsylvania (1985) and his MD (1989) and MPH (1995) degrees at Harvard. He completed residency in internal medicine and fellowship in nephrology at Brigham and Women’s Hospital before joining the Harvard faculty, where he remained until 1998. He then joined the faculty at University of California San Francisco, where he served as Director of Clinical Services in the Division of Nephrology and was promoted through the academic ranks to full Professor in the Departments of Medicine and Epidemiology and Biostatistics until joining the Stanford faculty as Professor and Division Chief in 2007. In addition to an active clinical practice, administrative responsibilities, teaching and mentoring, Dr. Chertow has developed and maintained a robust clinical research program. He has served or is currently serving in leadership roles for multiple NIDDK-, NHLBI-, and VA-sponsored clinical trials, including HEMO, DAC, ATN, FHN, SPRINT, PRESERVE, ISCHEMIA CKD, CURE-GN and TiME, and for several industry-sponsored clinical trials including TREAT, EVOLVE, BEACON, SYMPLICITY, REPRISE, CREDENCE, and DAPA-CKD. He has served in an advisory capacity to the Medicare Payment Advisory Committee and the National Quality Forum on issues related to the ESRD program, on NIH study sections and in multiple roles with the American Society of Nephrology (ASN), including the Public Policy Board, Quality Metrics Taskforce, and as Associate Editor of the society’s leading journal. He is Co-Editor of Brenner and Rector’s The Kidney . Dr. Chertow was honored by the American Kidney Fund in 2007 with the National Torchbearer Award and in 2011 with the Nephrologist of the Year Award, in recognition of his contributions to the care of persons with kidney disease. Dr. Chertow was elected to the American Society of Clinical Investigation in 2004, and in 2015, received the Belding H. Scribner Award from ASN and was elected to the Association of American Physicians and the National Academy of Medicine (formerly Institute of Medicine). In 2018, Dr. Chertow received the David M. Hume Memorial Award, the highest honor given by the National Kidney Foundation to a distinguished scientist-clinician in the field of kidney and urologic diseases. Suneel Gupta, Ph.D. Dr. Gupta is currently the Chief Development Officer at Protagonist. Previously, he was Chief Scientific Officer at Impax Pharmaceuticals, having joined them in 2008 and before that Dr. Gupta previously was with ALZA Corporation, a wholly owned subsidiary of Johnson & Johnson, for nearly 20 years. There, he was responsible for the strategic vision and execution of clinical research and development as Senior Vice President and distinguished research fellow. Dr Gupta’s research interest focuses on the influence of rate and route of drug delivery to discover new indications, as well as maximize clinical utility and/or effectiveness. With extensive experience in the development of drug delivery-based products across many therapeutic areas, Dr. Gupta has made significant contributions to the development of several therapeutics including Duragesic®, Durotap®, Nicoderm®, Testoderm®, Effidac®, Covera-HS®, Ditropan-XL®, Concerta®, Ionsys®, Jurnista®, Invega® and Priligy®. Before ALZA, he worked at Ciba Geigy (India) where he was responsible for scale-up and manufacturing of several products. Dr. Gupta received his PhD from the University of Manchester and was a Postdoctoral Fellow at UCSF. He is a coauthor on more than 200 research publications and co-inventor on more than 40 patents. Dominic Marasco, R.Ph. Mr. Marasco is the Chief Commercial Officer of BioAgilytix Labs, based in Durham, NC. He has more than 20 years of executive experience in C-suite strategic planning, commercial operations, global business development, clinical PhIII trial design strategy, alliance management, financial resourcing and P&L oversight within the Pharmaceutical, Biotech and Medical Device industries. Prior to joining BioAgilytix, he served as Executive Vice President, Global Business Development, Commercial at Syneos Health, where he led the overall strategic direction of the global business development team for the commercial division both in the U.S. and internationally. He was also previously Head of U.S. Sales for the Neuroscience Business Unit at Amgen, Inc. and prior to that Global Commercial Head, Amgen Biosimilars. Mr. Marasco has also held executive-level commercial and business development positions at Sandoz Biopharmaceuticals (a Novartis company) and IQVIA (formerly Quintiles). Mr. Marasco is a University of Southern California Adjunct Associate Professor of Pharmaceuticals and Health Economics for the School of Pharmacy and a member of the Health Policy and Management Executive Council at the Harvard T.H. Chan School of Public Health. He received his Bachelor of Science in Pharmacy from the Philadelphia College of Pharmacy and is a registered pharmacist with a current active licensure. Our arrangements with these individuals do not entitle us to any of their existing or future intellectual property derived from their independent research or research with other third parties. - 68 - Delinquent Section 16(a) Reports Section 16(a) of the Exchange Act requires our directors and executive officers, and persons who own more than 10% of a registered class of our equity securities, to file with the SEC initial reports of ownership and reports of changes in ownership of our common stock and other equity securities. To our knowledge, based solely upon a review of Forms 3, 4, and 5 filed with the SEC during the fiscal year ended December 31, 2021, we believe that, our directors, executive officers, and greater than 10% beneficial owners have complied with all applicable filing requirements during the fiscal year ended December 31, 2021. Code of Business Conduct and Ethics We have adopted a written code of business conduct and ethics that applies to our directors, officers and employees, including our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions. A copy of the code is filed as an exhibit to this Annual Report on Form 10-K and is posted on our website, www. unicycive.com . We intend to post on our website all disclosures that are required by law or Nasdaq rules concerning any amendments to, or waivers from, any provision of the code. Changes in Nominating Procedures None. ITEM 11. EXECUTIVE COMPENSATION Summary Compensation Table The following table sets forth the total compensation paid or accrued during the years ended December 31, 2020 and 2021 to our named executive officers: Name and Principal Position Year Salary (1) ($) Bonus (1) ($) Option Awards (2) ($) All Other Compensation (3) ($) Total ($) Shalabh Gupta, M.D., 2021 669,775 124,187 330,729 - 1,124,691 Chief Executive Officer 2020 495,000 148,500 - - 643,500 Pramod Gupta, Ph.D., 2021 187,500 - 231,555 68,750 487,805 Executive VP Pharmaceutical and Business Operations 2020 - - 212,250 60,000 272,250 John Townsend, CPA, 2021 91,667 - 185,253 106,197 383,117 Chief Financial Officer 2020 - - - 39,750 39,750 (1) Represents salary and bonus earned, but not all paid. (2) Represents the aggregate grant date fair values of stock option awards in accordance with FASB ASC No. 718-10. These values have been determined under the principles used to calculate the grant date fair market value of equity awards for purposes of the Company’s financial statements. The fair value of the common stock underlying the Company’s stock options prior to the IPO was estimated at each grant date and was determined on a periodic basis and based either on transactions with third parties in which common stock was sold for cash or with the assistance of an independent third-party valuation expert. Subsequent to our IPO, the fair value underlying the Company’s common stock is determined based on the public market closing price on each date of grant. Other assumptions used in our valuation of grants include expected term, volatility, and a risk-free interest rate. (3) Represents consulting fees earned prior to commencing formal employment with the Company. - 69 - Outstanding Equity Awards at December 31, 2021 The following table provides information regarding awards held by each of our named executive officers that were outstanding as of December 31, 2021. Name and Principal Position Number of Securities Underlying Unexercised Options (#) (Exercisable) Number of Securities Underlying Unexercised Options (#) (Unexercisable) Option Exercise Price ($) Option Expiration Date Shalabh Gupta, M.D., Chief Executive Officer - 170,543 0.13 – 5.00 8/2023 – 7/2031 Pramod Gupta, Ph.D., Executive VP Pharmaceutical and Business Operations 63,710 128,152 3.27 – 7.01 10/2029 – 7/2031 John Townsend, CPA, Chief Financial Officer - 41,861 5.00 – 7.01 3/2031 – 7/2031 Non-Employee Director Compensation The following table sets forth the total compensation paid or accrued during the years ended December 31, 2020 and 2021 to our non-employee directors: Name Year Option Awards (2) ($) Fees Earned or Paid in Cash ($) Total ($) Sandeep Laumas, M.D. (1) 2021 - 27,500 27,500 2020 - - - John Ryan, M.D., Ph.D. (2) 2021 - 24,750 24,750 2020 - - - Brigitte Schiller, M.D. (3) 2021 150,000 25,438 175,438 2020 - - - (1) Dr. Laumas was paid $27,500 as compensation for services as a member of the board of directors, chairman of the audit committee, and member of the compensation committee. (2) Dr. Ryan was paid $24,750 as compensation for services as a member of the board of directors, chairman of the compensation committee, and member of the nomination and corporate governance committee. (3) Dr. Schiller was paid $25,438 as compensation for services as a member of the board of directors, chairman of the nomination and corporate governance committee, and member of the audit committee. In connection with Dr. Schiller’s appointment to the board of directors in 2021, she received an option grant worth $50,000 on the date of grant and a restricted stock unit award worth $100,000 on the date of grant. - 70 - Employment Agreements Shalabh Gupta Employment Agreement On May 18, 2021, we entered into an employment agreement with Dr. Gupta, pursuant to which Dr. Gupta serves as our Founder and Chief Executive Officer. Dr. Gupta’s employment agreement provides for an annual base salary of $550,000 and provides that Dr. Gupta will be eligible for an annual discretionary bonus, with a target equal to 100% of his base salary, based on the achievement of certain performance objectives established by our Board of Directors. In accordance with the terms of Dr. Gupta’s employment agreement, he received a one-time equity grant of 116,279 stock options, which shall vest over a period of three years from the date of grant. In addition, Dr. Gupta’s employment agreement contains standard non-competition and non-solicitation provisions. Dr. Gupta is also eligible to receive additional equity-based compensation awards as the Company may grant from time to time. Dr. Gupta’s employment agreement further provides for standard expense reimbursement, vacation time and other standard executive benefits. Pursuant to Dr. Gupta’s employment agreement, in the event his employment is terminated without cause, due to a non-renewal by the Company, or if he resigns for “good reason” (in each case, other than within twelve (12) months following a change in control), Dr. Gupta is entitled to (i) a cash payment equal to one and one-half (1.5) times the sum of his (x) annual base salary and (y) target bonus in effect on his last day of employment; (ii) continuation of health benefits for a period of 18 months; (iii) a lump sum payment equal to the amount of any annual bonus earned with respect to a prior fiscal year, but unpaid as of the date of termination; (iv) a lump sum payment equal to the amount of annual bonus that was accrued through the date of termination for the year in which employment ends; and (v) subject to Dr. Gupta’s compliance with his restrictive covenants, the outstanding and unvested portion of any time-vesting equity award that would have vested during the one (1) year period following Dr. Gupta’s termination had he remained an employee shall automatically vest upon his termination date. In the event that Dr. Gupta’s employment is terminated due to his death or disability, he will be entitled to receive (i) a lump sum payment equal to the amount of any annual bonus earned with respect to a prior fiscal year, but unpaid as of the date of termination; (ii) a lump sum payment equal to the amount of annual bonus that was accrued for the year in which employment ends; and (iii) the acceleration and vesting in full of any then outstanding and unvested portion of any time-vesting equity award granted to him by the Company. In the event that Dr. Gupta’s employment is terminated due to his non-renewal or resignation without “good reason,” he will be entitled to receive a lump sum payment equal to the amount of any annual bonus earned with respect to a prior fiscal year, but unpaid as of the date of termination. In the event that Dr. Gupta’s employment is terminated by the Company without cause, due to non-renewal by the Company, or if he resigns for “good reason,” in each case within twelve (12) months following a change in control, Dr. Gupta is entitled to (i) a cash payment equal to two (2) times the sum of his (x) annual base salary and (y) target bonus in effect on his last day of employment; (ii) continuation of health benefits for a period of 24 months; (iii) a lump sum payment equal to the amount of any annual bonus earned with respect to a prior fiscal year, but unpaid as of the date of termination; (iv) a lump sum payment equal to the amount of annual bonus that was accrued for the year in which employment ends prior to the date of termination; and (v) the acceleration and vesting in full of any then outstanding and unvested portion of any time-vesting equity award granted to him by the Company. Pramod Gupta Employment Agreement On March 22, 2021 (as amended April 28, 2021), we entered into an employment agreement with Mr. Gupta, pursuant to which Mr. Gupta serves as our Executive Vice President, Pharmaceutical and Business Operations. Mr. Gupta’s employment agreement provides for an annual base salary of $450,000 and provides that Mr. Gupta will be eligible for an annual discretionary bonus, with a target amount equal to 50% of his base salary, based on the achievement of certain performance objectives established by our Board of Directors. In accordance with the terms of Mr. Gupta’s employment agreement, he received a one-time equity grant of 34,884 stock options, which shall vest over a period of three years from the date of grant. In addition, Mr. Gupta’s employment agreement contains standard non-competition and non-solicitation provisions. Mr. Gupta is also eligible to receive additional equity-based compensation awards as the Company may grant from time to time. Mr. Gupta’s employment agreement further provides for standard expense reimbursement, vacation time and other standard executive benefits. - 71 - Pursuant to Mr. Gupta’s employment agreement, in the event his employment is terminated without cause, due to non-renewal by the Company, or if he resigns for “good reason,” (in each case, other than within twelve (12) months following a change in control), Mr. Gupta is entitled to (i) a cash payment equal to the sum of his (x) annual base salary and (y) target bonus in effect on his last day of employment; (ii) continuation of health benefits for a period of 12 months; (iii) a lump sum payment equal to the amount of any annual bonus earned with respect to a prior fiscal year, but unpaid as of the date of termination; (iv) a lump sum payment equal to the amount of annual bonus that was accrued through the date of termination for the year in which employment ends; and (v) subject to Mr. Gupta’s compliance with his restrictive covenants, the outstanding and unvested portion of any time-vesting equity award that would vest on the next vesting date shall automatically vest upon his termination date, multiplied by a fraction, where the numerator is the number of days Mr. Gupta was employed since the last vesting date (or the date of grant, if such termination occurs prior to the first vesting date applicable to any such award) and the denominator is the total number of days since the last vesting date (or the date of grant, if such termination occurs prior to the first vesting date applicable to any such award) until the next vesting date. In the event that Mr. Gupta’s employment is terminated due to his death or disability, he will be entitled to receive (i) a lump sum payment equal to the amount of any annual bonus earned with respect to a prior fiscal year, but unpaid as of the date of termination; (ii) a lump sum payment equal to the amount of annual bonus that was accrued for the year in which employment ends; and (iii) the acceleration and vesting in full of any then outstanding and unvested portion of any time-vesting equity award granted to him by the Company. In the event that Mr. Gupta’s employment is terminated due to his non-renewal or resignation without “good reason,” he will be entitled to receive a lump sum payment equal to the amount of any annual bonus earned with respect to a prior fiscal year, but unpaid as of the date of termination. In the event that Mr. Gupta’s employment is terminated by the Company without cause, due to non-renewal by the Company, or if he resigns for “good reason,” in each case within twelve (12) months following a change in control, Mr. Gupta is entitled to (i) a cash payment equal to the sum of his (x) annual base salary and (y) target bonus in effect on his last day of employment; (ii) continuation of health benefits for a period of 12 months; (iii) a lump sum payment equal to the amount of any annual bonus earned with respect to a prior fiscal year, but unpaid as of the date of termination; (iv) a lump sum payment equal to the amount of annual bonus that was accrued for the year in which employment ends prior to the date of termination; and (v) the acceleration and vesting in full of any then outstanding and unvested portion of any time-vesting equity award granted to him by the Company. John Townsend Employment Agreement On July 2, 2021 we entered into an employment agreement with Mr. John Townsend, pursuant to which Mr. Townsend serves as our Chief Financial Officer. Mr. Townsend’s employment agreement provides for an annual base salary of $220,000 and provides that Mr. Townsend will be eligible for an annual discretionary bonus, with a target amount equal to 30% of his base salary, based on the achievement of certain performance objectives established by our Board of Directors. In accordance with the terms of Mr. Townsend’s employment agreement, he received a one-time equity grant of 18,605 stock options, which shall vest over a period of three years from the date of grant. In addition, Mr. Townsend’s employment agreement contains standard non-competition and non-solicitation provisions. Mr. Townsend is also eligible to receive additional equity-based compensation awards as the Company may grant from time to time. Mr. Townsend’s employment agreement further provides for standard expense reimbursement, vacation time and other standard executive benefits. - 72 - ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS The following table sets forth certain information regarding the beneficial ownership of our common stock as of March 31, 2022 by: ● each of our named executive officers; ● each of our directors; ● all of our current directors and named executive officers as a group; and ● each stockholder known by us to own beneficially more than 5% of our common stock. Beneficial ownership is determined in accordance with the rules of the SEC and includes voting or investment power with respect to the securities. Shares of common stock that may be acquired by an individual or group within 60 days of March 31, 2022, pursuant to the exercise of options or warrants, vesting of common stock or conversion of convertible debt, are deemed to be outstanding for the purpose of computing the percentage ownership of such individual or group, but are not deemed to be outstanding for the purpose of computing the percentage ownership of any other person shown in the table. Percentage of ownership is based on 14,996,534 shares of common stock issued and outstanding as of March 31, 2022. Unless noted otherwise, the address of all listed stockholders is c/o Unicycive Therapeutics, Inc., 4300 El Camino Real, Suite 210, Los Altos, CA 94022. Except as indicated by the footnotes below, we believe, based on information furnished to us, that each of the stockholders listed has sole voting and investment power with respect to the shares beneficially owned by the stockholder unless noted otherwise, subject to community property laws where applicable. Name of Beneficial Owner Shares of Common Stock Beneficially Owned Percentage Directors and Named Executive Officers: Shalabh Gupta, M.D. 5,841,726 (1) 38.9 % John Townsend 6,298 (2) * % John Ryan, M.D., Ph.D. 68,799 (3) * % Sandeep Laumas, M.D. 116,474 (4) * % Pramod Gupta, Ph.D. 81,152 (5) * % Brigitte Schiller - * % All current named executive officers and directors as a group (6 persons) 6,114,449 40.7 % * Represents beneficial ownership of less than 1%. (1) Includes 20,349 shares of common stock issuable upon exercise of vested stock options and 6,783 shares of common stock issuable upon exercise of stock options that vest within 60 days of March 31, 2022. Excludes 27,132 shares of common stock issuable upon exercise of stock options that are subject to vesting. (2) Includes 5,814 shares of common stock issuable upon exercise of vested stock options and 484 shares of common stock issuable upon exercise of stock options that vest within 60 days of March 31, 2022. Excludes 16,958 shares of common stock issuable upon exercise of stock options that are subject to vesting. (3) Includes 10,417 shares of common stock issuable upon exercise of vested stock options and 242 shares of common stock issuable upon exercise of stock options that vest within 60 days of March 31, 2022. Excludes 969 shares of common stock issuable upon exercise of stock options that are subject to vesting. (4) Includes 10,417 shares of common stock issuable upon exercise of vested stock options and 242 shares of common stock issuable upon exercise of stock options that vest within 60 days of March 31, 2022. Excludes 969 shares of common stock issuable upon exercise of stock options that are subject to vesting. (5) Includes 77,881 shares of common stock issuable upon exercise of vested stock options and 3,271 shares of common stock issuable upon exercise of stock options that vest within 60 days of March 31, 2022. Excludes 110,710 shares of common stock issuable upon exercise of stock options that are subject to vesting. - 73 - Securities Authorized for Issuance Under Equity Compensation Plans The following table summarizes information about our equity compensation plans as of December 31, 2021. Plan Category Number of securities to be issued upon exercise of outstanding options, warrants and rights (a) Weighted average exercise price of outstanding options, warrants and rights Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a)) 2018 Equity Incentive Plan 156,969 $ 0.01 - 2019 Stock Option Plan 425,949 $ 4.43 - 2021 Omnibus Equity Incentive Plan 628,150 $ 3.15 674,176 Total 1,211,068 $ 3.19 674,176 ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE The following includes a summary of transactions during our fiscal year ended December 31, 2020 and 2021 to which we have been a party, including transactions in which the amount involved in the transaction exceeds the lesser of $120,000 or 1% of the average of our total assets at year-end for the last two completed fiscal years, and in which any of our directors, executive officers or, to our knowledge, beneficial owners of more than 5% of our capital stock or any member of the immediate family of any of the foregoing persons had or will have a direct or indirect material interest, other than equity and other compensation, termination, change in control and other arrangements, which are described elsewhere in this Annual Report on Form 10-K. We are not otherwise a party to a related party transaction, and no transaction is currently proposed, in which the amount of the transaction exceeds the lesser of $120,000 or 1% of the average of our total assets at year-end for the last two completed fiscal years and in which a related person had or will have a direct or indirect material interest. Service Agreement with Globavir Biosciences, Inc. We entered into a Service Agreement on July 1, 2017, as amended on April 6, 2020 (“Service Agreement”), with Globavir Biosciences, Inc. (“Globavir”). Our Chief Executive Officer is also the Chief Executive Officer of Globavir. Pursuant to the Service Agreement, we receive administrative, consulting services, shared office space and other services in connection with our drug development programs. The initial amended term of the Service Agreement expired on December 31, 2020, and the agreement automatically renews for successive one month periods after the initial termination date. Pursuant to the Service Agreement, we paid Globavir $50,000 per month through December 31, 2019 and $10,000 per month commencing on January 1, 2020. As of December 31, 2020, $9,000 was payable to Globavir for service fees. During the fourth quarter of 2021, we determined that future services under the Service Agreement were no longer required, and we wrote off the $28,000 remaining prepaid balance due from Globavir as of December 31, 2021. Service fee expenses were $120,000 and $148,000 for the years ended December 31, 2020 and 2021, respectively, and were recorded as general and administrative expenses in the statements of operations. Related Person Transaction Policy We have adopted a related person transaction policy that sets forth our procedures for the identification, review, consideration and approval or ratification of related person transactions. For purposes of our policy only, a related person transaction is a transaction, arrangement or relationship, or any series of similar transactions, arrangements or relationships, in which we and any related person are, were or will be participants in which the amount involved exceeds the lesser of $120,000 or 1% of our total assets at year-end. Transactions involving compensation for services provided to us as an employee or director are not covered by this policy. A related person is any executive officer, director or beneficial owner of more than 5% of any class of our voting securities, including any of their immediate family members and any entity owned or controlled by such persons. - 74 - Under the policy, if a transaction has been identified as a related person transaction, including any transaction that was not a related person transaction when originally consummated or any transaction that was not initially identified as a related person transaction prior to consummation, our management must present information regarding the related person transaction to our audit committee, or, if audit committee approval would be inappropriate, to another independent body of our board of directors, for review, consideration and approval or ratification. The presentation must include a description of, among other things, the material facts, the interests, direct and indirect, of the related persons, the benefits to us of the transaction and whether the transaction is on terms that are comparable to the terms available to or from, as the case may be, an unrelated third party or to or from employees generally. Under the policy, we will collect information that we deem reasonably necessary from each director, executive officer and, to the extent feasible, significant stockholder to enable us to identify any existing or potential related-person transactions and to effectuate the terms of the policy. In addition, under our Code of Business Conduct and Ethics, our employees and directors will have an affirmative responsibility to disclose any transaction or relationship that reasonably could be expected to give rise to a conflict of interest. In considering related person transactions, our audit committee, or other independent body of our board of directors, will take into account the relevant available facts and circumstances including, but not limited to: ● the risks, costs and benefits to us; ● the impact on a director’s independence in the event that the related person is a director, immediate family member of a director or an entity with which a director is affiliated; ● the availability of other sources for comparable services or products; and ● the terms available to or from, as the case may be, unrelated third parties or to or from employees generally. The policy requires that, in determining whether to approve, ratify or reject a related person transaction, our audit committee, or other independent body of our board of directors, must consider, in light of known circumstances, whether the transaction is in, or is not inconsistent with, our best interests and those of our stockholders, as our audit committee, or other independent body of our board of directors, determines in the good faith exercise of its discretion. Independence of the Board of Directors Our board of directors undertook a review of the independence of our directors and considered whether any director has a relationship with us that could compromise that director’s ability to exercise independent judgment in carrying out that director’s responsibilities. Our board of directors has affirmatively determined that Dr. Laumas, Dr. Ryan, and Dr. Schiller are each an “independent director,” as defined under Nasdaq rules. ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES The following table sets forth the aggregate fees billed by Mayer Hoffman McCann (“MHM”). Substantially all MHM’s personnel, who work under the control of MHM shareholders, are employees of wholly-owned subsidiaries of CBIZ, Inc., which provides personnel and various services to MHM in an alternative practice structure. 2020 2021 Audit fees $ 284,222 $ 327,411 Audit related fees - - Tax fees - - All other fees - - Total $ 284,222 $ 327,411 Audit Fees: Fees for audit services on an accrued basis. Audit-Related Fees: Fees not included in audit fees that are billed by the auditor for assurance and related services that are reasonably related to the performance of the audit of the financial statements. Tax Fees: Fees for professional services rendered for tax compliance, tax advice and tax planning. All Other Fees: All other fees billed by the auditor for products and services not included in the foregoing categories. Pre-Approval Policies and Procedures In accordance with the Sarbanes-Oxley Act, our audit committee charter requires the audit committee to pre-approve all audit and permitted non-audit services provided by our independent registered public accounting firm, including the review and approval in advance of our independent registered public accounting firm’s annual engagement letter and the proposed fees contained therein. The audit committee has the ability to delegate the authority to pre-approve non-audit services to one or more designated members of the audit committee. If such authority is delegated, such delegated members of the audit committee must report to the full audit committee at the next audit committee meeting all items pre-approved by such delegated members. In the fiscal years ended December 31, 2020 and 2021 all of the services performed by our independent registered public accounting firm were pre-approved by the audit committee. - 75 - PART IV ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES (a) The following documents are filed as part of this report: (1) Financial Statements: The financial statements required by this Item are included beginning at page F-1. (2) Financial Statement Schedules: All financial statement schedules have been omitted because they are not applicable, not required or the information required is shown in the financial statements or the notes thereto. (b) Exhibits The following documents are included as exhibits to this report. Exhibit No. Description 3.1 Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.4 to Amendment No. 2 to Form S-1 filed on June 21, 2021) 3.2 Amended and Restated Bylaws (incorporated by reference to Exhibit 3.5 to Amendment No. 2 to Form S-1 filed on June 21, 2021) 4.1 Specimen Stock Certificate evidencing the shares of common stock (incorporated by reference to Exhibit 4.1 to Form S-1 filed on May 21, 2021) 4.2 Form of Warrant Agent Agreement (including the terms of the Warrant) (incorporated by reference to Exhibit 4.2 to Amendment No. 2 to Form S-1 filed on June 21, 2021) 4.3 Form of Underwriter’s Unit Purchase Option (incorporated by reference to Exhibit 4.3 to Amendment No. 2 to Form S-1 filed on May 21, 2021) 4.4 Description of the Registrant's Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934. 10.1+ 2018 Equity Incentive Plan (incorporated by reference to Exhibit 10.3 to Amendment No. 1 to Form S-1 filed on June 7, 2021) 10.2+ 2019 Stock Option Plan (incorporated by reference to Exhibit 10.3 to Amendment No. 1 to Form S-1 filed on June 7, 2021) 10.3+ 2021 Omnibus Equity Incentive Plan (incorporated by reference to Exhibit 10.3 to Form S-1 filed on May 21, 2021) 10.4 Assignment and Asset Purchase Agreement by and between the Company and Spectrum Pharmaceuticals, Inc., dated September 20, 2018 (incorporated by reference to Exhibit 10.4 to Amendment No. 1 to Form S-1 filed on June 7, 2021) 10.5 Exclusive License Agreement by and between the Company and Sphaera Pharma Pte. Ltd., dated October 1, 2017 (incorporated by reference to Exhibit 10.5 to Amendment No. 1 to Form S-1 filed on June 7, 2021) 10.6 Service Agreement by and between the Company and Globavir Biosciences, Inc. dated July 1, 2017 (incorporated by reference to Exhibit 10.3 to Amendment No. 1 to Form S-1 filed on June 7, 2021) 10.7+ Employment Agreement by and between the Company and Shalabh Gupta, M.D., dated May 18, 2021 (incorporated by reference to Exhibit 10.7 to Form S-1 filed on May 21, 2021) 10.8+ Employment Agreement by and between the Company and Pramod Gupta, M.D., dated March 22, 2021 incorporated by reference to Exhibit 10.8 to Form S-1 filed on May 21, 2021) 10.9+ Amendment to Employment Agreement by and between the Company and Pramod Gupta, M.D., dated April 28, 2021 (incorporated by reference to Exhibit 10.9 to Form S-1 filed on May 21, 2021) 10.10# Master Services Agreement, dated February 8, 2021, by and between Unicycive Therapeutics, Inc. and Ascent Development Services, Inc. (incorporated by reference to Exhibit 10.10 to Form S-1 filed on May 21, 2021) 14.1 Code of Business Conduct and Ethics 23.1 Consent of Mayer Hoffman McCann P.C., independent registered public accounting firm 24.1 Power of Attorney (included on signature page hereto) 31.1 Certification of Principal Executive Officer required under Rule 13a-14(a)/15d-14(a) under the Exchange Act. 31.2 Certification of Principal Financial Officer required under Rule 13a-14(a)/15d-14(a) under the Exchange Act. 32.1 Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. 32.2 Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. 101.INS Inline XBRL Instance Document. 101.SCH Inline XBRL Taxonomy Extension Schema Document. 101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document. 101.LAB Inline XBRL Taxonomy Extension Labels Linkbase Document. 101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document. 101.DEF Inline XBRL Taxonomy Extension Definition Linkbase Document . 104 Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). + Indicates a management contract or any compensatory plan, contract or arrangement. # Portions of this exhibit (indicated by asterisks) have been redacted in compliance with Regulation S-K Item 601(b)(10)(iv). ITEM 16. FORM 10-K SUMMARY None. - 76 - SIGNATURES Pursuant to the requirements of Section 13 and 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this Annual Report on Form 10-K to be signed on its behalf by the undersigned, thereunto duly authorized on this 31st day of March, 2022. UNICYCIVE THERAPEUTICS, INC. /s/ Shalabh Gupta Shalabh Gupta Chief Executive Officer (Principal Executive Officer), President and Chairman of the Board of Directors POWER OF ATTORNEY KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below hereby constitutes and appoints Shalabh Gupta as his or her attorney-in-fact, with full power of substitution and resubstitution, for him or her in any and all capacities, to sign any and all amendments to this Annual Report on Form 10-K, and to file the same, with exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorney-in-fact full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming all that said attorney-in-fact, or his substitute or substitutes, may lawfully do or cause to be done by virtue hereof. Pursuant to the requirements of the Securities Act of 1934, this Annual Report on Form 10-K has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated. Signature Title Date /s/ Shalabh Gupta Chief Executive Officer (Principal Executive Officer), March 31, 2022 Shalabh Gupta President and Chairman of the Board of Directors /s/ John Townsend Chief Financial Officer March 31, 2022 John Townsend (Principal Financial and Accounting Officer) /s/ John Ryan, M.D., Ph.D. Director March 31, 2022 John Ryan, M.D., Ph.D. /s/ Sandeep Laumas, M.D. Director March 31, 2022 Sandeep Laumas, M.D. /s/ Brigitte Schiller, M.D. Director March 31, 2022 Brigitte Schiller, M.D. -77-