UNCY

- Company expects to resubmit New Drug Application (NDA) for oxylanthanum carbonate (OLC) assuming completion of successful inspection of third-party manufacturing vendor - FDA has assigned a facility inspection to third-party manufacturing vendor of OLC - As of June 30, 2026, unaudited cash, cash equivalents, and marketable securities totaled $61.4 million, with expected runway into 2027 MOUNTAIN VIEW, Calif., Aug. 12, 2026 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the second quarter ended June 30, 2026, and provided a business update. “We are focused on securing approval of oxylanthanum carbonate (OLC) and remain confident in the efficacy and safety of OLC and in its potential to improve care for patients with hyperphosphatemia on dialysis,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “The latest update from our third-party manufacturing vendor is that the U.S. Food and Drug Administration (FDA) has assigned a facility inspection. This marks a positive step forward, and our dialogue with the FDA on OLC labeling and packaging has been productive and continuous throughout this process. We are optimistic about a successful inspection of the third-party manufacturing facility, which would enable us to promptly resubmit the NDA. In the meantime, we are well positioned to launch OLC as quickly as possible following potential approval, and we are utilizing this time to continue to expand market awareness in preparation for the commercial success of OLC.” Key Highlights & Upcoming Milestones In June, the Company received a Complete Response Letter (CRL) from the FDA regarding the resubmitted NDA for OLC for the treatment of hyperphosphatemia in patients with chronic kidney disease on dialysis. The CRL cites the same third-party manufacturing deficiencies identified in a previous CRL issued in June 2025. The FDA has not raised any concerns regarding clinical efficacy or safety data, and no additional data was requested from the Company. The Company’s third-party vendor has received written notification from the FDA that the facility inspection has been assigned, and the Company plans to provide an update following completion of the FDA inspection. In preparation for the potential launch of OLC, the Company continues to advance its commercial readiness initiatives. Unicycive is focused on optimizing patient access across all reimbursement settings and plans to support patients with dedicated access and reimbursement services through its UniSource™ reimbursement hub. The Company will also engage with the patient and clinical community at several medical meetings during the third quarter, including the 51st Annual American Association of Kidney Patients National Patient Meeting (September 11–13, Little Rock, Arkansas) and the 2026 Renal Healthcare Association Annual Conference (September 23–26, Savannah, Georgia). Financial Results for the Quarter Ended June 30, 2026 Research and Development (R&D) expense was $2.8 million for the quarter ended June 30, 2026, compared to $1.8 million for the three months ended June 30, 2025. The increase was primarily driven by a $0.9 million increase in non-cash stock-based compensation, and an increase in consulting and professional fees of $0.1 million. General and Administrative (G&A) expense was $7.4 million for the quarter ended June 30, 2026, compared to $5.2 million for the three months ended June 30, 2025. The increase was primarily driven by a $1.4 million increase in non-cash stock-based compensation as well as an increase of $0.3 million in other labor costs. There was also an increase of $0.4 million related to commercial launch preparation. Other income (expense) was $8.4 million for the quarter ended June 30, 2026, compared to $0.5 million income for the three months ended June 30, 2025, attributed primarily to an increase in the fair value of the Company’s warrant liability. Net loss attributable to common stockholders, basic and diluted, for the quarter ended June 30, 2026, was $(1.7) million, or $(0.06) per share of common stock, compared to $(6.5) million loss, or $(0.52) per share of common stock, for the three months ended June 30, 2025. The decreased net loss for the quarter ended June 30, 2026, was attributed primarily to a decrease in the fair value of the Company’s warrant liability. About Unicycive Therapeutics Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding agent for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information, please visit Unicycive.com and follow us on LinkedIn and X. Forward-looking statementsCertain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Unicycive's expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive's current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; our dependence on third parties for manufacturing; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; market acceptance of our products; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2025, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Investor Contacts:Kevin GardnerLifeSci [email protected] Media Contact:Unicycive [email protected] SOURCE: Unicycive Therapeutics, Inc.

Unicycive Therapeutics, Inc. (NASDAQ:UNCY) shares gained 2.00% in premarket trading on Wednesday after the clinical-stage biotechnology company reported a second-quarter loss that was considerably narrower than Wall Street expected. The company posted a loss of $0.06 per share for the quarter, compared with the analyst consensus forecast for a loss of $0.48 per share. Unicycive, which is developing treatments for patients with kidney diseases, remains a clinical-stage company and does not currently generate revenue. For the quarter ended June 30, 2026, Unicycive recorded a net loss of $1.7 million, a substantial improvement from the $6.5 million loss reported in the corresponding period last year. The reduction was primarily linked to a change in the fair value of the company’s warrant liability, which generated $8.0 million of other income during the quarter. Operating expenses increased, however, as Unicycive continued investing in its clinical and commercial development activities. In June, Unicycive received a Complete Response Letter from the U.S. Food and Drug Administration regarding its resubmitted New Drug Application for oxylanthanum carbonate, or OLC. The treatment is being developed for hyperphosphatemia in patients with chronic kidney disease who are receiving dialysis. The FDA’s letter identified deficiencies involving a third-party manufacturing facility but did not raise concerns about the clinical efficacy or safety data supporting OLC. A facility inspection has now been assigned by the FDA to the third-party manufacturing vendor. Unicycive expects to resubmit its NDA once the inspection has been completed successfully. “We are focused on securing approval of oxylanthanum carbonate and remain confident in the efficacy and safety of OLC and in its potential to improve care for patients with hyperphosphatemia on dialysis,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. Research and development expenses rose to $2.8 million during the second quarter from $1.8 million in the same period last year. The increase was primarily attributed to higher stock-based compensation expenses. General and administrative costs climbed to $7.4 million from $5.2 million year on year, reflecting both increased stock-based compensation and spending associated with preparations for a potential commercial launch. Unicycive reported $61.4 million in cash, cash equivalents and marketable securities as of June 30, 2026. The company expects its existing financial resources to provide a cash runway into 2027 as it works to resolve the manufacturing issues identified by the FDA and advance OLC towards potential regulatory approval. The positive premarket reaction followed the narrower-than-expected quarterly loss, while investors continue to focus on the timing of the manufacturing inspection and a subsequent OLC regulatory resubmission. Unicycive Therapeutics stock price

U.S. Food and Drug Administration (FDA) review of oxylanthanum carbonate (OLC) New Drug Application (NDA) resubmission remains on track, with a Prescription Drug User Fee Act (PDUFA) target action date of June 29, 2026 Commercial readiness activities continue in anticipation of the potential commercial launch of OLC MOUNTAIN VIEW, Calif., May 12, 2026 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the first quarter ended March 31, 2026, and provided a business update. “As we approach the June 29th PDUFA target action date, we remain optimistic about the potential approval of OLC and focused on preparations for the subsequent launch of OLC,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “Our ongoing dialogue with the FDA during the review cycle has been constructive and timely. Uncontrolled hyperphosphatemia remains a significant health concern, affecting nearly 75% of U.S. patients with chronic kidney disease who are undergoing dialysis. OLC has the potential to improve adherence and phosphorus control with reduced pill burden, compared with currently available phosphate binders.” Key Highlights & Upcoming Milestones In January 2026, the Company announced the FDA accepted the resubmission of its NDA for OLC, an investigational oral phosphate binder for the treatment of hyperphosphatemia in patients with CKD on dialysis. The FDA set a PDUFA target action date of June 29, 2026. The NDA is supported by data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study in patients with CKD on dialysis), multiple preclinical studies, and chemistry, manufacturing, and controls (CMC) data. The FDA did not raise any concerns regarding the preclinical, clinical, or safety data for OLC included in the original NDA submission. The December 2025 resubmission was based on progress made by the third-party manufacturing vendor responsible for the drug product. In preparation for a potential launch of OLC later this year, the Company continues to strengthen its commercial infrastructure and advance market readiness initiatives. Unicycive’s goal is to optimize patient access across all reimbursement settings and intends to provide dedicated access and reimbursement support services for all patients through Unicycive’s UniSource™ reimbursement hub. Financial Results for the Quarter Ended March 31, 2026 As of May 11, 2026, unaudited cash, cash equivalents, and marketable securities totaled $57.1 million. The Company believes that it has sufficient resources to fund planned operations into 2027. Research and Development (R&D) expense were $1.6 million for the quarter ended March 31, 2026, compared to $2.2 million for the three months ended March 31, 2025. The decrease in research and development expense was primarily attributed to a decrease in drug development costs as well as consulting and professional fees. General and Administrative (G&A) expense were $6.8 million for the quarter ended March 31, 2026, compared to $5.8 million for the three months ended March 31, 2025. The increase was primarily attributed to an increase in consulting, professional services, and labor costs. Other income (expense) was $(4.4) million for the quarter ended March 31, 2026, compared to $8.6 million income for the three months ended March 31, 2025, attributed primarily to an increase in the fair value of the Company’s warrant liability. Net comprehensive income (loss) attributable to common stockholders, basic for the quarter ended March 31, 2026, was $(12.8) million, or $(0.54) per share of common stock, compared to $0.5 million income, or $0.04 per share of common stock, for the three months ended March 31, 2025. Net comprehensive income (loss) attributable to common stockholders, diluted for the quarter ended March 31, 2026, was $(12.8) million, or $(0.54) per share of common stock, compared to $(6.2) million, or $(0.50) per share of common stock, for the three months ended March 31, 2025. The increased net loss for the quarter ended March 31, 2026, was attributed primarily to an increase in the fair value of the Company’s warrant liability. About Unicycive Therapeutics Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding agent currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information, please visit Unicycive.com and follow us on LinkedIn and X. Forward-looking statementsCertain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Unicycive's expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive's current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; our dependence on third parties for manufacturing; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; market acceptance of our products; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2025, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Investor Contacts: Kevin GardnerLifeSci [email protected] Media Contact: Layne LitsingerReal [email protected] SOURCE: Unicycive Therapeutics, Inc.

Oxylanthanum carbonate (OLC) New Drug Application (NDA) resubmission under review by U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date of June 29, 2026 Commercial readiness activities ongoing in anticipation of potential commercial launch of OLC in 3Q26 As of March 30, 2026 unaudited cash, cash equivalents, and marketable securities totaled $54.9 million, with expected runway into 2027 LOS ALTOS, Calif., March 30, 2026 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the full year ended December 31, 2025, and provided a business update. “This year is shaping up to be pivotal for Unicycive, underscored by the U.S. Food and Drug Administration’s acceptance of our New Drug Application resubmission for OLC and the potential for approval and launch later this year,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “With hyperphosphatemia still uncontrolled in nearly 75% of U.S. patients with chronic kidney disease undergoing dialysis, OLC, if approved, has the potential to offer a meaningful new treatment option characterized by a differentiated clinical profile and reduced pill burden compared to currently available phosphate binders.” Key Highlights & Upcoming Milestones In January 2026, the Company announced the FDA has accepted the resubmission of its NDA for OLC, an investigational oral phosphate binder for the treatment of hyperphosphatemia in patients with CKD on dialysis. The FDA set a PDUFA target action date of June 29, 2026. The NDA is supported by data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers and a tolerability study in patients with CKD on dialysis), multiple preclinical studies and chemistry, manufacturing and controls (CMC) data. The FDA did not raise any concerns regarding the preclinical, clinical or safety data for OLC included in the original NDA submission. The resubmission in December 2025 was based on the progress made by the third-party manufacturing vendor responsible for the drug product (Drug Product). As part of Unicycive’s continued preparation to support a potential launch of OLC later this year, the Company is continuing to strengthen its commercial infrastructure and advance market readiness initiatives. Financial Results for the Year Ended December 31, 2025 Research and Development (R&D) expenses were $9.1 million for the year ended December 31, 2025, compared to $20.0 million for the same period in 2024. The decrease in research and development expenses was primarily due to a decrease in drug development as well as clinical trial costs. General and Administrative (G&A) expenses were $20.4 million for the year ended December 31, 2025, compared to $12.1 million for the same period in 2024. The increase was primarily due to an increase in consulting, professional services, and commercial launch preparation costs. Other income was $3.0 million for the year ended December 31, 2025 compared to Other expense of $4.6 million in the same period in 2024 due primarily to a decrease in the fair value of the Company’s warrant liability. Net loss attributable to common stockholders for the year ended December 31, 2025 was $26.6 million, or $1.67 per share of common stock, compared to a net loss attributable to common stockholders of $37.8 million, or $5.65 per share of common stock for the same period in 2024. The decreased net loss for the year ended December 31, 2025, was attributable primarily to the decrease in drug development and clinical trial costs. As of March 30, 2026 unaudited cash, cash equivalents, and marketable securities totaled $54.9 million. The Company believes that it has sufficient resources to fund planned operations into 2027. About Unicycive Therapeutics Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding agent currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information, please visit Unicycive.com and follow us on LinkedIn and X. Forward-looking statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Unicycive's expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive's current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; our dependence on third parties for manufacturing; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; market acceptance of our products; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2025, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Investor Contacts: Kevin Gardner LifeSci Advisors [email protected] Media Contact: Layne Litsinger Real Chemistry [email protected] SOURCE: Unicycive Therapeutics, Inc.

- Remain on track to resubmit the New Drug Application (NDA) for oxylanthanum carbonate (OLC) by year end - Presented new analysis of OLC data at American Society of Nephrology (ASN) which demonstrates that OLC significantly reduced pill burden in terms of both pill volume (7x) and pill count (2x) compared to currently available phosphate binders - Ended Q3 with $42.7 million of cash with expected runway into 2027 LOS ALTOS, Calif., Nov. 12, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the three months ended September 30, 2025, and provided a business update. “With a continued commitment to advancing OLC, we are poised to resubmit the NDA for OLC by the end of the year, following positive discussions with the FDA and our third-party manufacturing vendor,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “Our focus has always been on enhancing the lives of people with hyperphosphatemia, as evidenced by the promising new data presented at ASN Kidney Week 2025 that showcase OLC’s differentiated clinical profile and reduced pill burden compared to currently available phosphate binders. With a cash runway into 2027, we are well positioned to complete the regulatory approval process and prepare for the potential launch of OLC next year, marking significant progress in advancing our mission to deliver improved treatment options for patients on dialysis.” Key Highlights & Upcoming Milestones Unicycive announced its intention to resubmit the NDA for OLC by year-end, with the potential to receive a new Prescription Drug User Fee Act (PDUFA) date in the first half of 2026. This announcement followed a Type A meeting with the U.S. Food and Drug Administration FDA. During the meeting, the FDA discussed the single deficiency noted in the CRL concerning a third-party manufacturing vendor, with no additional issues identified to the Company, including preclinical, clinical, or safety data. Following the receipt of our CRL in June, our third-party manufacturing vendor was recently inspected by EU regulatory authorities with no deficiencies identified. After the Type A meeting and discussions with our third party manufacturing vendor, we remain optimistic about the resolution of the CRL deficiency and our ability to refile. Company presented new data on OLC at the American Society of Nephrology (ASN) Kidney Week 2025. Findings from the open-label pivotal trial demonstrate that OLC significantly reduced pill burden compared to pre-trial phosphate binder therapy, with a 7-fold decrease in pill volume and a 2-fold reduction in pill count. Financial Results for the Quarter Ended September 30, 2025 Research and Development (R&D) expenses were $3.0 million for the three months ended September 30, 2025, compared to approximately $3.1 million for the three months ended September 30, 2024. The decrease in research and development expenses was primarily due to a $235,000 decrease in professional services and drug development costs, partially offset by increases in labor, travel, and other costs of $154,000. General and Administrative (G&A) expenses were $4.4 million for the three months ended September 30, 2025, compared to $3.2 million for the three months ended September 30, 2024. The increase was primarily due to a $0.6 million increase in labor costs and a $0.5 million increase in consulting and professional services. Other income was $1.3 million for the three months ended September 30, 2025, compared to other income of $2.2 million for the three months ended September 30, 2024. The decrease was primarily due to the change in fair value of our warrant liability. Net loss attributable to common stockholders for the three months ended September 30, 2025, was $6.0 million, compared to net loss attributable to common stockholders of $4.1 million for the three months ended September 30, 2024. The increased net loss for the three-month period ended September 30, 2025 was primarily due to increased labor and professional services costs as well as the change in fair value of our warrant liability. As of September 30, 2025, cash and cash equivalents totaled $42.7 million. The Company believes that it has a cash runway into 2027. About Unicycive Therapeutics Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding agent for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information about Unicycive, visit Unicycive.com and follow us on LinkedIn and X. Forward-looking statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Unicycive's expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive's current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; our need to raise substantial additional capital in the future to fund our continuing operations and the development and commercialization of our current product candidates and future product candidates; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; risks related to delays in obtaining or failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; and our failure, or the failure of our third-party manufacturers, or their subcontractors, to comply with cGMPs or other applicable regulations, which could result in sanctions being imposed on us or the manufacturers, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates, operating restrictions and criminal prosecutions, any of which could adversely affect supplies of our product candidates and harm our business and results of operations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Investor Contacts: Kevin Gardner LifeSci Advisors [email protected] Media Contact: Layne Litsinger Real Chemistry [email protected] SOURCE: Unicycive Therapeutics, Inc.

- Type A Meeting requested with U.S. Food and Drug Administration (FDA) for resolution of the Complete Response Letter (CRL) for oxylanthanum carbonate (OLC) - OLC pivotal study data, published in the Clinical Journal of the American Society of Nephrology (CJASN), demonstrated OLC was well tolerated and enabled serum phosphate control in over 90% of patients with a low pill burden - Ended Q2 with $22.3 million of cash with expected runway into the second half of 2026 LOS ALTOS, Calif., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the three months ended June 30, 2025, and provided a business update. “Our team has made great progress in the second quarter, and we have requested a Type A meeting with the FDA to resolve the CRL and obtain regulatory approval. We believe we have built multiple approaches to correct the deficiency noted for our third-party manufacturing vendor, which was unrelated to OLC,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “Meanwhile, the recently published pivotal trial data in CJASN continue to highlight OLC’s best-in-class potential. Given the high rates of patient non-compliance with existing phosphate lowering therapies, we remain fully committed to meeting this clear need for improved treatment options for managing hyperphosphatemia in dialysis patients.” Key Highlights & Upcoming Milestones Unicycive has requested a Type A meeting with the FDA to discuss resolution of the CRL received in June in regard to its New Drug Application for OLC. Typically, Type A meetings are granted by the FDA within 30 days of the request. The Company plans to provide an investor update in the third quarter once it has received the FDA’s written feedback. In July, the Company announced the publication of pivotal clinical study data describing the safety and tolerability of OLC in CKD patients on dialysis in CJASN. Data demonstrated that OLC was well tolerated, with over 90% of patients achieving effective phosphate control with most individuals needing no more than one tablet per meal. Financial Results for the Quarter Ended June 30, 2025 Research and Development (R&D) expenses were $1.8 million for the three months ended June 30, 2025, compared to $4.9 million for the three months ended June 30, 2024. The decrease in research and development expenses was primarily due to decreased drug development costs. General and Administrative (G&A) expenses were $5.2 million for the three months ended June 30, 2025, compared to $2.5 million for the three months ended June 30, 2024. The increase was primarily due to increased consulting and professional services related to our commercial launch preparation. Other income was $0.5 million for the three months ended June 30, 2025, compared to other income of $17.3 million for the three months ended June 30, 2024, primarily due to the change in fair value of our warrant liability. Net loss attributable to common stockholders for the three months ended June 30, 2025, was $6.4 million, compared to net income attributable to common stockholders of $3.0 million for the three months ended June 30, 2024. The increased net loss for the three-month period ended June 30, 2025 was primarily due to the change in fair value of our warrant liability. As of June 30, 2025, cash and cash equivalents totaled $22.3 million. The Company believes that it has sufficient resources to fund operations into the second half of 2026. About Unicycive Therapeutics Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding agent for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information about Unicycive, visit Unicycive.com and follow us on LinkedIn and X. Forward-looking statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Unicycive's expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive's current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; our need to raise substantial additional capital in the future to fund our continuing operations and the development and commercialization of our current product candidates and future product candidates; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; risks related to delays in obtaining or failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; and our failure, or the failure of our third-party manufacturers, or their subcontractors, to comply with cGMPs or other applicable regulations, which could result in sanctions being imposed on us or the manufacturers, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates, operating restrictions and criminal prosecutions, any of which could adversely affect supplies of our product candidates and harm our business and results of operations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Investor Contacts: Kevin Gardner LifeSci Advisors [email protected] Media Contact: Rachel Visi Real Chemistry [email protected] SOURCE: Unicycive Therapeutics, Inc.

- Oxylanthanum carbonate (OLC) New Drug Application (NDA) for hyperphosphatemia in chronic kidney disease patients on dialysis under review by FDA with PDUFA target action date of June 28, 2025; ongoing commercial planning in preparation for anticipated commercial launch in late 2025 - New data from patient surveys and patient-reported outcomes studies highlight adherence challenges for patients with hyperphosphatemia on dialysis and emphasize the market potential of OLC LOS ALTOS, Calif., May 14, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the three months ended March 31, 2025, and provided a business update. “We are making incredible strides as we prepare for the potential FDA approval of oxylanthanum carbonate (OLC) so we can bring this treatment to people with chronic kidney disease (CKD) on dialysis as efficiently as possible,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “The need for our differentiated treatment, which offers high potency and a significantly reduced pill burden for people struggling to control hyperphosphatemia, has been further validated by new patient survey findings and patient-reported outcomes data. We remain dedicated to bolstering our commercial infrastructure as we strive to deliver a much-needed solution to patients and healthcare providers.” Key Highlights & Upcoming Milestones The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2025, for OLC. Unicycive continues to prepare for the potential launch of OLC by building key functions, engaging directly with prescribers and other stakeholders, and supporting market access. Expanded awareness of OLC and its potential to address significant needs for CKD patients by publishing data and presentations at medical meetings. Recently, findings were presented at the National Kidney Foundation (NKF) Spring Clinical Meetings and the 2025 American Nephrology Nurses Association (ANNA) National Symposium from a patient survey conducted in partnership with the NKF. The survey included a total of 200 dialysis patients who identified excessive pill numbers, large pill sizes, and forgetfulness as the primary barriers to phosphate binder adherence. Patients also expressed a strong preference for medication regimens with fewer and smaller pills. New patient-reported outcomes data from the pivotal Phase 2 study of OLC were presented at the 2025 American Dialysis Conference (ADC) and the NKF Spring Clinical Meeting, which demonstrated that patients preferred OLC in comparison to their pre-trial phosphate binder medications and significantly enhanced patient satisfaction. Financial Results for the Quarter Ended March 31, 2025 Research and Development (R&D) expenses were $2.2 million for the three months ended March 31, 2025, compared to $6.8 million for the three months ended March 31, 2024. The decrease in research and development expenses was primarily due to decreased drug development costs. General and Administrative (G&A) expenses were $5.8 million for the three months ended March 31, 2025, compared to $2.4 million for the three months ended March 31, 2024. The increase was primarily due to increased consulting and professional services related to our commercial launch preparation. In addition to the above launch expenses, we continue to focus on the manufacturing of commercial supplies, as reflected in prepaid expenses and other current assets on our balance sheet which increased from $4.8 million as of December 31, 2024 to $7.6 million as of March 31, 2025. Other income was $8.6 million for the three months ended March 31, 2025, compared to an expense of $11.8 million for the three months ended March 31, 2024, primarily due to a decrease in the fair value of our warrant liability. Net income attributable to common stockholders for the three months ended March 31, 2025, was $0.5 million, compared to a net loss attributable to common stockholders of $21.2 million for the three months ended March 31, 2024. The net income for the three-month period ended March 31, 2025, was primarily due to a decrease in the fair value of our warrant liability. As of March 31, 2025, cash and cash equivalents totaled $19.8 million. About Unicycive Therapeutics Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding agent currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information about Unicycive, visit Unicycive.com and follow us on LinkedIn and X. Forward-looking statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Unicycive's expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive's current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; our need to raise substantial additional capital in the future to fund our continuing operations and the development and commercialization of our current product candidates and future product candidates; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; risks related to delays in obtaining or failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; and our failure, or the failure of our third-party manufacturers, or their subcontractors, to comply with cGMPs or other applicable regulations, which could result in sanctions being imposed on us or the manufacturers, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates, operating restrictions and criminal prosecutions, any of which could adversely affect supplies of our product candidates and harm our business and results of operations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Investor Contacts: Kevin Gardner LifeSci Advisors [email protected] Media Contact: Rachel Visi Real Chemistry [email protected] SOURCE: Unicycive Therapeutics, Inc.

- Oxylanthanum carbonate (OLC) New Drug Application for hyperphosphatemia in chronic kidney disease patients on dialysis under review by the FDA with a PDUFA target action date of June 28, 2025 - Commercial planning in preparation for anticipated commercial launch of OLC in late 2025 LOS ALTOS, Calif., March 31, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the full year ended December 31, 2024, and provided a business update. “2025 is positioned to be a transformational year for Unicycive, with the near-term potential for FDA approval and commercial launch of oxylanthanum carbonate (OLC),” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “For approximately 75% of people in the U.S. with chronic kidney disease (CKD) on dialysis, hyperphosphatemia remains uncontrolled because of challenges with currently available phosphate binders, potentially increasing their risk of hospitalization and mortality. If approved, we believe OLC is positioned to be an important new option for these patients, distinguished by its high potency and a low pill burden. We continue to actively prepare to launch OLC, including educating key stakeholders on existing OLC data and preparing our commercial infrastructure to rapidly make OLC available to patients upon approval.” Key Highlights & Upcoming Milestones Announced the acceptance of the New Drug Application (NDA) by the U.S. Food and Drug Administration (FDA) for OLC for the treatment of hyperphosphatemia in patients with CKD on dialysis. The FDA set a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2025. Unicycive’s partner in the Republic of Korea, Lotus Pharmaceutical, submitted an NDA for OLC with the Ministry of Food and Drug Safety and anticipates an application decision in June of 2026. Unicycive has an exclusive license agreement with Lotus Pharmaceutical for the development, registration, and commercialization of OLC in the Republic of Korea and has the potential to receive up to $3.7 million in milestone payments and tiered royalties based on regulatory and commercial achievements. Continued efforts to establish an efficient commercial infrastructure, including building key functions, engaging directly with prescribers and other stakeholders and preparing to support market access are ongoing. Expanded awareness of OLC and its potential to address significant needs for CKD patients through publication of data, including in the peer-reviewed journals Clinical Therapeutics, Clinical and Translational Science, and Journal of Nephrological Science; and late-breaker presentation at the American Society of Nephrology (ASN) Kidney Week 2024. These data included clinical, preclinical and patient survey/literature review data that highlighted OLC’s favorable safety and tolerability profile, efficacy in controlling serum phosphate levels, and the need for new options to overcome the current limitations of phosphate binders and their effects on patients’ quality of life. The data also demonstrated OLC’s bioequivalence to approved lanthanum carbonate chewable tablets, and the potential benefits of combination treatment of OLC and tenapanor on phosphate management. Successfully completed Phase 1 study of UNI-494 in healthy volunteers, which demonstrated favorable tolerability, with fast absorption and rapid metabolization. Data from the Phase 1 study and supportive preclinical data were presented at ASN 2024 and published in EC Pharmacology and Toxicology. Financial Results for the Year Ended December 31, 2024 Licensing revenues decreased approximately $0.7 million, from the year ended December 31, 2023 due to an upfront payment of approximately $0.7 million associated with a licensing agreement entered into with Lotus International Pte Ltd. in February 2023. There was no comparable revenue earned in the current period. Research and Development (R&D) expenses were $20.0 million for the year ended December 31, 2024, compared to $12.9 million for the same period in 2023. The increase in research and development expenses was primarily due to an increase in drug development and labor costs. General and Administrative (G&A) expenses were $12.1 million for the year ended December 31, 2024, compared to $8.5 million for the same period in 2023. The increase was primarily due to an increase in labor, consulting and professional services costs. Other Income was $4.6 million for the year ended December 31, 2024 compared to $9.8 million in the same period in 2023 due primarily to a decrease in the fair value of our warrant liability. Net loss attributable to common stockholders for the year ended December 31, 2024 was $37.8 million, or $0.56 per share of common stock, compared to a net loss attributable to common stockholders of $31.4 million, or $1.28 per share of common stock for the same period in 2023. The increased net loss for the year ended December 31, 2024 was attributable primarily to an increase in drug development costs. As of December 31, 2024, cash and cash equivalents totaled $26.1 million. The Company believes that it has sufficient resources to fund planned operations into 2026. About Unicycive Therapeutics Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. Positive pivotal trial results were reported in June 2024 for OLC, and a New Drug Application (NDA) is under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) Target Action Date of June 28, 2025. OLC is protected by a strong global patent portfolio including an issued patent on composition of matter with exclusivity until 2031, and with the potential patent term extension until 2035 after OLC approval. Unicycive’s second asset, UNI-494, is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury. UNI-494 has successfully completed a Phase 1 trial. For more information, please visit Unicycive.com and follow us on LinkedIn, X, and YouTube. Forward-looking statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Unicycive's expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive's current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; our dependence on third parties for manufacturing; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; market acceptance of our products; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Investor Contacts: Kevin Gardner LifeSci Advisors [email protected] Media Contact: Rachel Visi Real Chemistry [email protected] SOURCE: Unicycive Therapeutics, Inc.