Unicycive Therapeutics Announces First Quarter 2026 Financial Results and Provides Business Update

Rhea-AI Summary

Unicycive Therapeutics (Nasdaq: UNCY) reported first quarter 2026 results and a business update. The FDA review of oxylanthanum carbonate (OLC) NDA resubmission remains on track with a PDUFA target action date of June 29, 2026.

Unaudited cash and investments were $57.1 million, which the company believes will fund operations into 2027. Q1 2026 R&D expense was $1.6 million, G&A expense was $6.8 million, and net loss attributable to common stockholders (basic) was $(12.8) million, or $(0.54) per share.

Positive

• FDA accepted OLC NDA resubmission with June 29, 2026 PDUFA date
• FDA reported no concerns on OLC preclinical, clinical, or safety data
• Cash, cash equivalents and marketable securities of $57.1 million as of May 11, 2026
• Resources expected to fund planned operations into 2027
• R&D expense decreased to $1.6 million from $2.2 million year over year
• Commercial infrastructure and UniSource reimbursement hub being prepared for potential OLC launch

Negative

• G&A expense increased to $6.8 million from $5.8 million year over year
• Other income (expense) was $(4.4) million versus $8.6 million income prior year
• Net loss attributable to common stockholders (basic) was $(12.8) million versus $0.5 million income
• Change in fair value of warrant liability materially impacted quarterly results

News Market Reaction – UNCY

+2.77%

+2.77% Session close to close

In the May 12 session, UNCY gained 2.77%, reflecting a moderate positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement combines Q1 2026 financials with confirmation that the OLC NDA resubmission remain...

Analysis

This announcement combines Q1 2026 financials with confirmation that the OLC NDA resubmission remains on track for a June 29, 2026 PDUFA decision. Cash and securities of $57.1M support the company’s stated runway into 2027, while R&D has declined and G&A has risen with commercial preparation. Historically, earnings tied to OLC have produced mixed stock responses. Investors may watch upcoming regulatory milestones, cash burn trends, and commercialization spend as key markers.

Key Figures

Cash & securities: $57.1M R&D expense: $1.6M G&A expense: $6.8M +5 more

8 metrics

Cash & securities $57.1M Unaudited, as of May 11, 2026; stated runway into 2027

R&D expense $1.6M Q1 2026 vs $2.2M in Q1 2025

G&A expense $6.8M Q1 2026 vs $5.8M in Q1 2025

Other income (expense) $(4.4)M Q1 2026 vs $8.6M income in Q1 2025, driven by warrant liability

Net income (loss), basic $(12.8)M Q1 2026 vs $0.5M income in Q1 2025

EPS, basic $(0.54) Q1 2026 vs $0.04 in Q1 2025

PDUFA date June 29, 2026 FDA target action date for OLC NDA resubmission

Hyperphosphatemia prevalence Nearly 75% U.S. CKD dialysis patients with uncontrolled hyperphosphatemia

Previous Earnings Reports

5 past events · Latest: Mar 30 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Mar 30	Full-year 2025 earnings	Positive	-4.4%	2025 results, NDA acceptance for OLC, runway into 2027 highlighted.
Nov 12	Q3 2025 earnings	Positive	+7.3%	Q3 results plus OLC resubmission plans and strong pill-burden data.
Aug 14	Q2 2025 earnings	Positive	+5.0%	Q2 results, pivotal OLC data with >90% control and lower R&D spend.
May 14	Q1 2025 earnings	Positive	-7.8%	Q1 results, June 28, 2025 PDUFA and improved net income from warrants.
Mar 31	Full-year 2024 earnings	Negative	-6.4%	2024 results with higher net loss and increased R&D and G&A spending.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Earnings and business updates around OLC often produced volatile but mixed reactions: average move -1.26% with three aligned and two divergent outcomes versus the news tone.

Recent Company History

Over the past year, earnings releases for Unicycive have repeatedly linked financial updates to regulatory progress for OLC. Prior reports highlighted milestones like NDA resubmission, evolving PDUFA timelines, and cash runways into 2026–2027. Financially, R&D has trended lower as major trials concluded, while G&A has risen with commercial build-out. Price reactions have been inconsistent, sometimes selling off after seemingly constructive updates. Today’s Q1 2026 report continues this pattern of pairing cash runway and OLC regulatory clarity with growing launch preparation detail.

Key Terms

new drug application (NDA), prescription drug user fee act (PDUFA), hyperphosphatemia, chronic kidney disease (CKD), +4 more

8 terms

new drug application (NDA) regulatory

"review of oxylanthanum carbonate (OLC) New Drug Application (NDA) resubmission remains on track"

A new drug application (NDA) is a formal request submitted to regulatory authorities to gain approval for a new medication to be sold and used by the public. It is a comprehensive review process that examines the drug’s safety, effectiveness, and manufacturing quality. For investors, an NDA approval can signal a potential breakthrough product and influence a company's stock value.

prescription drug user fee act (PDUFA) regulatory

"with a Prescription Drug User Fee Act (PDUFA) target action date of June 29, 2026"

The Prescription Drug User Fee Act (PDUFA) is a law that allows drug companies to pay fees to the government to help speed up the review process for new medicines. This funding aims to ensure that important drugs reach patients faster, which can influence a company's ability to bring products to market efficiently. For investors, PDUFA-related decisions can impact drug approval timelines and company performance.

hyperphosphatemia medical

"Uncontrolled hyperphosphatemia remains a significant health concern, affecting nearly 75% of U.S. patients"

An elevated level of phosphate in the blood, often caused by reduced kidney function or certain medications, that can harm bones, blood vessels and organs if untreated. Investors should care because prevalence, safety concerns and regulatory scrutiny around treatments or diagnostics for this condition can drive demand, affect clinical trial outcomes, influence healthcare spending and change a company’s revenue and risk profile—similar to how a common road hazard can change demand for safety products.

chronic kidney disease (CKD) medical

"hyperphosphatemia in patients with CKD on dialysis"

Chronic kidney disease (CKD) is a long-term decline in the kidneys’ ability to filter waste and balance fluids and chemicals in the body, often progressing slowly over months or years; think of it as a filter that gradually becomes clogged and less effective. It matters to investors because CKD drives demand for drugs, dialysis, transplants, diagnostics and related medical devices, influences healthcare costs and reimbursement decisions, and is a common target for clinical trials and regulatory review.

bioequivalence medical

"a bioequivalence study in healthy volunteers, and a tolerability study in patients with CKD"

When two medicines deliver the same amount of active ingredient into the bloodstream at about the same speed and level, they are considered bioequivalent. Investors care because bioequivalence is the regulatory test that allows generic or reformulated drugs to replace branded products without new safety trials, often opening large, lower‑cost market opportunities and changing a drug maker’s sales and competitive position—like two recipes that taste the same but sell at different prices.

chemistry, manufacturing, and controls (CMC) regulatory

"multiple preclinical studies, and chemistry, manufacturing, and controls (CMC) data"

Chemistry, manufacturing, and controls (CMC) is the collection of information and data that describes a drug’s recipe, how it is made at scale, and the quality checks that ensure each batch is consistent and safe. For investors, CMC matters because regulators use it to decide approvals and manufacturing reliability; weak or incomplete CMC can delay launches, raise production costs, or create supply risks much like a flawed recipe or factory process undermines a product’s reliability.

phosphate binder medical

"an investigational oral phosphate binder for the treatment of hyperphosphatemia"

A phosphate binder is a medication taken with meals that sticks to dietary phosphate in the gut so the body absorbs less of it, similar to a sponge catching spilled particles before they spread. It matters to investors because these drugs are a steady, often long-term treatment for people with impaired kidney function; sales, reimbursement rules, and new clinical or regulatory data can affect a drug maker’s revenue and a healthcare payer’s costs.

tolerability study medical

"a bioequivalence study in healthy volunteers, and a tolerability study in patients"

A tolerability study is a type of clinical test that measures how well people can handle a drug or treatment by tracking side effects, discomfort, and whether doses need adjusting. Think of it like a test drive that focuses on comfort and rough spots rather than performance. For investors, tolerability results signal safety risks, potential delays or extra costs in development, and influence a treatment’s chances of clearing regulators and reaching the market.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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• 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 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
kgardner@lifesciadvisors.com

Media Contact:

Layne Litsinger
Real Chemistry
llitsinger@realchemistry.com

SOURCE: Unicycive Therapeutics, Inc.

Unicycive Therapeutics, Inc.
Balance Sheets
(in thousands, except for share and per share amounts)
		As of				As of
		December 31,				March 31,
		2025				2026
Assets						(Unaudited)
Current assets:
Cash		$	29,198			$	37,371
Prepaid expenses and other current assets			7,692				8,959
Marketable securities			12,071				17,215
Total current assets			48,961				63,545
Right of use asset, net			108				813
Property and equipment, net			66				48
Total assets		$	49,135			$	64,406
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable		$	383			$	1,140
Accrued liabilities			1,523				3,052
Warrant liability			16,915				21,695
Operating lease liability - current			117				598
Total current liabilities			18,938				26,485
Operating lease liability - long term			-				217
Total liabilities			18,938				26,702
Commitments and contingencies
Stockholders’ equity:
Series A-2 Prime preferred stock, $0.001 par value per share - 21,388.01 Series A-2 Prime shares authorized at December 31, 2025, and March 31, 2026; 2,265 Series A-2 Prime shares issued and outstanding at December 31, 2025, and March 31, 2026			-				-
Series B-2 preferred stock, $0.001 par value per share - 50,000 Series B-2 shares authorized at December 31, 2025, and March 31, 2026; zero Series B-2 shares issued and outstanding at December 31, 2025, and March 31, 2026			-				-
Preferred stock, $0.001 par value per share- 10,000,000 shares authorized at December 31, 2025, and March 31, 2026; zero shares issued and outstanding at December 31, 2025, and March 31, 2026			-				-
Common stock, $0.001 par value per share - 400,000,000 shares authorized at December 31, 2025, and March 31, 2026; 22,114,245 and 25,237,782 shares issued and outstanding at December 31, 2025, and March 31, 2026, respectively			22				25
Accumulated other comprehensive (loss) income			(1	)			6
Additional paid-in capital			158,001				178,321
Accumulated deficit			(127,825	)			(140,648	)
Total stockholders’ equity			30,197				37,704
Total liabilities and stockholders’ equity		$	49,135			$	64,406

Unicycive Therapeutics, Inc.
Statements of Operations and Comprehensive Income (Loss)
(in thousands, except for share and per share amounts)
(Unaudited)
			Three Months				Three Months
			Ended				Ended
			March 31,				March 31,
		2025				2026
Operating expenses:
Research and development		$	2,171			$	1,607
General and administrative			5,818				6,830
Total operating expenses			7,989				8,437
Loss from operations			(7,989	)			(8,437	)
Other income (expenses):
Interest income			226				394
Interest expense			(15	)			-
Change in fair value of warrant liability			8,348				(4,780	)
Total other income (expenses)			8,559				(4,386	)
Net income (loss)			570				(12,823	)
Other comprehensive loss:
Unrealized loss on marketable securities, net			-				(1	)
Net comprehensive income (loss)		$	570			$	(12,824	)
Net comprehensive income (loss) attributable to common stockholders, basic		$	510			$	(12,824	)
Net comprehensive (loss) attributable to common stockholders, diluted		$	(6,214	)		$	(12,824	)
Net comprehensive income (loss) per share
Basic		$	0.04			$	(0.54	)
Diluted		$	(0.50	)		$	(0.54	)
Weighted-average shares outstanding used in computing net comprehensive income (loss) per share
Basic			11,681,881				23,908,153
Diluted			12,383,477				23,908,153

FAQ

What were Unicycive Therapeutics' (UNCY) key financial results for Q1 2026?

Unicycive reported a Q1 2026 net loss attributable to common stockholders (basic) of $(12.8) million, or $(0.54) per share. According to Unicycive, R&D expense was $1.6 million and G&A expense was $6.8 million for the quarter ended March 31, 2026.

What is the FDA PDUFA date for Unicycive's OLC NDA and why is it important for UNCY stock?

The FDA set a PDUFA target action date of June 29, 2026 for OLC. According to Unicycive, this date marks when the FDA is expected to complete its review of the NDA resubmission, a key milestone for potential approval and commercialization efforts.

Did the FDA raise any safety or efficacy concerns about Unicycive's OLC in the NDA review?

The FDA did not raise concerns regarding the preclinical, clinical, or safety data for OLC in the original NDA. According to Unicycive, the resubmission was primarily based on progress by the third-party manufacturing vendor responsible for the drug product.

How long does Unicycive Therapeutics (UNCY) expect its cash to fund operations after Q1 2026?

Unicycive reported unaudited cash, cash equivalents, and marketable securities of $57.1 million as of May 11, 2026. According to Unicycive, these resources are expected to fund planned operations into 2027, supporting ongoing regulatory, commercial, and development activities.

How did Unicycive's research and development and G&A expenses change in Q1 2026?

R&D expense decreased to $1.6 million for Q1 2026 from $2.2 million a year earlier. According to Unicycive, G&A expense increased to $6.8 million from $5.8 million, mainly due to higher consulting, professional services, and labor costs.

What clinical data support Unicycive's OLC NDA resubmission to the FDA?

The OLC NDA is supported by three clinical studies and additional data. According to Unicycive, these include a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, a tolerability study in CKD patients on dialysis, plus multiple preclinical and CMC data packages.

What commercialization preparations is Unicycive making for a potential OLC launch in 2026?

Unicycive is strengthening its commercial infrastructure and advancing market readiness initiatives ahead of a potential OLC launch. According to Unicycive, the company aims to optimize patient access and plans dedicated support through its UniSource reimbursement hub across reimbursement settings.