Financial Performance and Losses - Net losses for the nine months ended September 30, 2023, and September 30, 2024, were $22.7 million and $15.2 million, respectively, with an accumulated deficit of $79.7 million as of September 30, 2024[188] - The company reported a net loss of $15.2 million for the nine months ended September 30, 2024, and expects to incur substantial additional losses in future periods, with an accumulated deficit of $79.7 million as of September 30, 2024[215] - Net cash used in operating activities was $22.0 million for the nine months ended September 30, 2024, primarily due to development costs for drug candidates, labor costs, and consulting services[223] Research and Development Expenses - Research and development expenses decreased by $0.4 million (10%) from $3.4 million in Q3 2023 to $3.0 million in Q3 2024, primarily due to a $0.4 million decrease in drug development costs[205] - Research and development expenses increased by $6.0 million, or 70%, from $8.7 million in the nine months ended September 30, 2023, to $14.7 million in the same period in 2024, driven by a $5.4 million increase in drug development costs[209] - Research and development expenses include fees paid to third parties, consulting costs, laboratory supplies, product acquisition and license costs, payroll and personnel-related expenses, and allocated overheads[233] General and Administrative Expenses - General and administrative expenses increased by $640,000 (25%) from $2.6 million in Q3 2023 to $3.2 million in Q3 2024, driven by a $715,000 increase in travel, rent, and other costs[206] - General and administrative expenses increased by $1.7 million, or 26%, from $6.5 million in the nine months ended September 30, 2023, to $8.1 million in the same period in 2024, due to higher non-cash stock compensation and labor costs[210] Regulatory and Drug Development - The company submitted a New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) to the FDA on September 3, 2024, with a PDUFA target action date of June 28, 2025[192] - The company expects operating expenses to increase significantly as it advances product candidates through clinical development and seeks regulatory approval[188] - The company entered into a securities purchase agreement in March 2023, which may provide up to $130.0 million in gross proceeds, with an initial upfront funding of $30.0 million, to support FDA submissions and the commercial launch of oxylanthanum carbonate[214] Financing Activities - The company raised $50 million through a private placement of Series B-1 Convertible Preferred Stock on March 13, 2024, with each share convertible into common stock at $1.00 per share[193] - The company issued 42,118,000 shares of common stock and 7,882 shares of Series B-2 preferred stock on July 5, 2024, following the automatic conversion of Series B-1 Convertible Preferred Stock[194] - Net cash provided by financing activities was $44.7 million during the nine months ended September 30, 2024, primarily due to a private placement financing agreement signed on March 13, 2024[227] - The company received $22.3 million in net proceeds from its IPO in July 2021, which were used for pre-clinical and clinical studies, regulatory filings, and general corporate purposes[212] Licensing and Revenue - Licensing revenues were $0 for both Q3 2023 and Q3 2024, with potential future revenue dependent on business development arrangements[204] - Licensing revenues decreased by $0.7 million, or 100%, in the nine months ended September 30, 2024, compared to the same period in 2023, due to an upfront payment from a licensing agreement in February 2023[208] Other Income and Expenses - Other income (expenses) increased by $0.5 million, or 34%, from $1.6 million in Q3 2023 to $2.2 million in Q3 2024, primarily due to a change in the fair value of the company's warrant liability[207] - Other income (expenses) increased by $15.5 million, or 178%, from an $8.7 million expense in the nine months ended September 30, 2023, to a $6.8 million income in the same period in 2024, primarily due to the change in fair value of the company's warrant liability[211] Market and Patient Statistics - The number of patients with end-stage renal disease (ESRD) in the U.S. is projected to reach between 971,000 and 1,259,000 by 2030, with approximately 450,000 patients (~80%) currently taking phosphate binders[184] - Acute kidney injury (AKI) affects over 2 million U.S. patients annually, costing the healthcare system more than $9 billion per year[185] Accounting and Reporting - Stock-based compensation is accounted for using the Black-Scholes option-pricing model, which requires subjective assumptions such as expected stock volatility, dividend yield, term, and risk-free interest rate[234] - The company qualifies as an "emerging growth company" under the JOBS Act, allowing it to delay the adoption of certain accounting standards until they apply to private companies[235] - The company intends to rely on exemptions under the JOBS Act, including not providing an auditor's attestation report on internal controls over financial reporting and not complying with PCAOB's critical audit matters requirement[237] - The company will remain an "emerging growth company" until it reaches $1.235 billion in total annual gross revenues, completes five years post-IPO, issues over $1 billion in nonconvertible debt, or becomes a large accelerated filer[237] - The company has no off-balance sheet arrangements as defined under SEC rules[239] - As a smaller reporting company, the company is not required to provide quantitative and qualitative disclosures about market risk[241]

– FDA sets PDUFA Action Date of June 28, 2025 – Company Preparing for 2025 Commercial Launch – LOS ALTOS, Calif., Nov. 11, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) and has set a Prescription Drug User Fee Act (PDUFA) ...

– Late-Breaker Poster Presentation Highlights Favorable Safety & Tolerability of OLC – – Two Publications Recently Issued Featuring OLC and UNI-494 – LOS ALTOS, Calif., Oct. 28, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced that multiple presentations were delivered at the American Society of Nephrology (ASN) Kidney Week 2024 that highlighted t ...

LOS ALTOS, Calif., Oct. 16, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the "Company" or "Unicycive"), today announced that Shalabh Gupta, M.D., Chief Executive Officer will participate in a fireside chat at the 2024 Maxim Healthcare Virtual Summit on Thursday, October 17, 2024 at 10:00 a.m. ET. A link to the live and archived webcast may be accessed on the Unicycive website under the Inve ...

LOS ALTOS, Calif., Oct. 14, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the "Company" or "Unicycive"), today announced that a poster presentation on oxylanthanum carbonate (OLC) was selected for a Late-Breaker session at the American Society of Nephrology (ASN) Kidney Week 2024. Unicycive will also deliver three additional poster presentations on OLC and UNI-494. The conference will take p ...

LOS ALTOS, Calif., Oct. 09, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the "Company" or "Unicycive"), today announced the successful completion of the UNI-494 Phase 1 study in healthy volunteers. "We are pleased to announce the successful completion of the UNI-494 Phase 1 study that informs our next steps for advancement to a potential Phase 2 clinical trial in patients with acute kidney ...

LOS ALTOS, Calif., Sept. 16, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the "Company" or "Unicycive"), today announced that Shalabh Gupta, M.D., Chief Executive Officer will present a corporate update at the Virtual Life Sciences Investor Forum on Thursday, September 19, 2024 at 2:00 p.m. ET in New York, NY. A link to the live and archived webcast may be accessed on the Unicycive website ...

LOS ALTOS, Calif., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the "Company" or "Unicycive"), today announced that the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Oxylanthanum Carbonate (OLC) for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. Unicycive is seeking FDA approval ...

LOS ALTOS, Calif., Aug. 26, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the "Company" or "Unicycive"), today announced that three poster presentations will be delivered on the Company's product candidates at the American Society of Nephrology (ASN) Kidney Week 2024 taking place October 24-27, 2024 in San Diego, CA. "Data from both oxylanthanum carbonate (OLC) and UNI-494 continue to garner ...

Exhibit 99.1 Unicycive Announces Second Quarter 2024 Financial Results and Provides Business Update – On Track to Submit OLC New Drug Application (NDA) by End of August 2024 – LOS ALTOS, Calif., August 14, 2024 – Unicycive Therapeutics, Inc. (Nasdaq: UNCY) (the "Company" or "Unicycive"), a clinicalstage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the three months ended June 30, 2024, and provided a business update. "Achieving success ...