Rezolute (RZLT) AI Stock Analysis

• Market Cap: $252.22M
• Dividend Yield: N/A
• Average Volume (3M): 11.60M
• Price to Earnings (P/E): ―
• Beta (1Y): 1.23
• Revenue Growth: N/A
• EPS Growth: 26.65%
• Country: US
• Employees: 64
• Sector: Healthcare
• Sector Strength: 45
• Industry: Biotechnology
• EPS (TTM): -0.18
• Shares Outstanding: 92,727,530
• 10 Day Avg. Volume: 4,924,471
• 30 Day Avg. Volume: 11,604,804
• PEG Ratio: 0.17
• Price to Book (P/B): 2.09
• Price to Sales (P/S): 0.00
• P/FCF Ratio: -4.91
• Enterprise Value/Market Cap: 3.26
• Enterprise Value/Revenue: N/A
• Enterprise Value/Gross Profit: -102.68K
• Enterprise Value/Ebitda: -10.13
• 1Y Price Target: $6.29
• Price Target Upside: 131.25% Upside
• Rating Consensus: Moderate Buy
• Number of Analyst Covering: 9
• EPS Forecast (FY): N/A
• Revenue Forecast (FY): N/A

• Rating: 44 Neutral
• Price Target: $2.00 ▼(-26.47% Downside)

The score is primarily weighed down by weak financial performance (no revenue, widening losses, and sustained cash burn) and bearish technicals (price below major moving averages and negative MACD). Corporate updates are mixed—Phase 3 miss is a key risk, partly offset by follow-on data and FDA-path discussions—while valuation is difficult to support given the negative P/E and no dividend yield.

Positive Factors

Low financial leverage

Extremely low leverage provides durable financial flexibility for a development-stage biotech, reducing insolvency risk and enabling sustained R&D spending or strategic deals without high interest burdens. This supports multi-quarter trial programs and optionality in capital structure decisions.

Pharmacologic activity and FDA engagement

Consistent biomarker responses and achieved therapeutic concentrations, plus Breakthrough Therapy discussions with FDA, indicate a credible biological signal and regulatory dialogue. This structural validation can enable alternative approval pathways or focused trials, preserving long-term development value.

Strong OLE retention and positive EAP outcomes

High conversion to and retention in the open-label extension and EAP evidence of discontinuing IV nutrition demonstrate tolerability and clinically meaningful benefit in severe cases. Durable patient-level outcomes bolster single-arm trial designs and real-world evidence for future regulatory or reimbursement discussions.

Negative Factors

Persistent pre-revenue losses and cash burn

The company remains pre-revenue with materially widening net losses and negative operating cash flow, indicating continued reliance on external funding. Sustained cash burn threatens runway, increases dilution risk, and pressures strategic options if clinical programs require prolonged enrollment or additional studies.

Phase 3 sunRIZE failed primary and key secondary endpoints

A Phase 3 miss materially reduces near-term approval probability for the congenital HI indication, complicates commercialization plans, and can force redesigns or new trials. This raises lasting regulatory and partner risk, and may require additional costly studies to establish statistically significant clinical benefit.

Reliance on external financing

As a development-stage biotech with no product revenue, Rezolute must repeatedly access capital markets to fund operations. Structural dependence on financings can dilute shareholders, constrain long-term strategic autonomy, and create vulnerability if market conditions or investor appetite weaken during extended development timelines.

Rezolute Business Overview & Revenue Model

Company Description

Rezolute, Inc., a clinical stage biopharmaceutical company, develops transformative therapies for metabolic diseases associated with chronic glucose imbalance in the United States. The company's lead product candidate is RZ358, a human monoclonal antibody that is in Phase 2b clinical trial for the treatment of congenital hyperinsulinism, an ultra-rare pediatric genetic disorder. It is also developing RZ402, a selective and potent plasma kallikrein inhibitor, which is in Phase 1 clinical trial for the chronic treatment of diabetic macular edema. The company was formerly known as AntriaBio, Inc. and changed its name to Rezolute, Inc. in December 2017. Rezolute, Inc. was founded in 2010 and is headquartered in Redwood City, California.

How the Company Makes Money

Rezolute generates revenue primarily through the development and potential commercialization of its proprietary drug candidates. The company aims to profit by advancing its products through clinical trials and obtaining regulatory approvals, leading to potential licensing agreements, partnerships, or direct sales. Revenues may also be supplemented by milestone payments or royalties from collaborations with larger pharmaceutical companies, which can provide financial support and distribution channels for their therapies. Currently, as a clinical-stage company, Rezolute may also rely on funding from investors, grants, and public offerings to support its research and development activities until its products reach the market.

Rezolute Financial Statement Overview

Summary

Rezolute faces significant financial challenges typical in biotechnology, with minimal revenue growth and substantial operational losses. The company maintains a strong equity position with low debt levels, but struggles with negative cash flow and profitability, reflecting operational inefficiencies.

Income Statement

Rezolute's revenue growth has been minimal with minor revenue in TTM after years of none, reflecting limited commercial success. The company has negative profitability margins with a net profit margin of -122639.66% and an EBIT margin of -94665.52% in TTM, indicating high operational losses relative to revenue. There is no visible trend of improvement in profitability as both EBIT and net income have consistently been negative.

Balance Sheet

Rezolute shows a strong equity position with an equity ratio of 88.90% in TTM, indicating low financial leverage. The debt-to-equity ratio is minimal at 0.02, suggesting low debt levels relative to equity. However, the return on equity is negative at -71.44%, reflecting continued losses impacting shareholder returns.

Cash Flow

The company's free cash flow is negative, and the operating cash flow to net income ratio is 0.89, evidencing cash burn. However, financing activities have been a source of cash, indicating reliance on external funding. Free cash flow growth remains negative, reflecting operational inefficiencies.

Breakdown	TTM	Dec 2025	Dec 2024	Dec 2023	Dec 2022	Dec 2021
Income Statement
Total Revenue	0.00	0.00	0.00	0.00	0.00	0.00
Gross Profit	-8.00K	0.00	0.00	0.00	0.00	-13.00K
EBITDA	-81.07M	-79.86M	-70.39M	-55.96M	-39.24M	-20.51M
Net Income	-77.18M	-74.41M	-68.46M	-51.79M	-41.06M	-20.90M
Balance Sheet
Total Assets	158.66M	175.49M	132.74M	123.72M	152.42M	42.61M
Cash, Cash Equivalents and Short-Term Investments	152.19M	167.86M	126.87M	101.90M	150.41M	41.05M
Total Debt	1.45M	1.61M	2.23M	2.48M	188.00K	14.42M
Total Liabilities	11.50M	13.36M	11.73M	7.55M	2.95M	16.51M
Stockholders Equity	147.17M	162.13M	121.00M	116.17M	149.47M	26.10M
Cash Flow
Free Cash Flow	-70.49M	-69.08M	-57.37M	-44.63M	-39.62M	-20.44M
Operating Cash Flow	-70.49M	-69.08M	-57.37M	-44.48M	-39.62M	-20.44M
Investing Cash Flow	-33.62M	-14.54M	48.70M	-101.46M	0.00	0.00
Financing Cash Flow	102.74M	107.33M	63.03M	11.57M	148.98M	51.53M

Rezolute Technical Analysis

• Technical Analysis Sentiment: Negative
• Last Price: 2.72
• 50DMA: Negative
• 100DMA: Negative
• 200DMA: Negative
• MACD: Negative
• RSI: Neutral
• STOCH: Neutral

Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For RZLT, the sentiment is Negative. The current price of 2.72 is above the 20-day moving average (MA) of 2.28, below the 50-day MA of 6.30, and below the 200-day MA of 5.91, indicating a neutral trend. The MACD of -1.01 indicates Negative momentum. The RSI at 39.77 is Neutral, neither overbought nor oversold. The STOCH value of 77.18 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for RZLT.

Rezolute Peers Comparison

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
KOD	54 Neutral	$1.75B	-6.96	-207.92%	―	―	-12.93%
TSHA	53 Neutral	$1.38B	-14.22	-64.93%	―	-36.36%	-945.72%
GERN	52 Neutral	$861.78M	―	-29.57%	―	522.13%	62.68%
Sector *	51 Neutral	$7.86B	-0.30	-43.30%	2.27%	22.53%	-2.21%
ABUS	49 Neutral	$919.31M	-21.55	-45.88%	―	116.64%	47.93%
XNCR	46 Neutral	$1.03B	-8.14	-19.61%	―	38.16%	48.43%
RZLT	44 Neutral	$252.22M	-2.93	-59.23%	―	―	26.65%

Rezolute Corporate Events

Rezolute Updates sunRIZE Phase 3 Trial and FDA Plans

On January 7, 2025, Rezolute reported detailed observations from its Phase 3 sunRIZE trial in congenital hyperinsulinism, noting that although the study did not meet its primary and key secondary endpoints for reducing hypoglycemia events and time in hypoglycemia, data showed clear pharmacologic activity of ersodetug and reductions from baseline that were confounded by a strong placebo effect and study design factors in an ambulatory glucose-monitoring setting. The company highlighted that all 59 patients who completed the controlled phase of sunRIZE chose to continue into the open-label extension and that many children there have discontinued all other therapies and remain on ersodetug monotherapy, while Rezolute prepares to discuss the full dataset and potential regulatory path with the FDA under its Breakthrough Therapy Designation in early 2026. Rezolute also released cumulative data from the first nine tumor hyperinsulinism patients treated with ersodetug in its expanded access program over the past two years, showing that 75% of those on IV dextrose or total parenteral nutrition were able to fully discontinue these infusions, evidence that supported redesign of the Phase 3 upLIFT tumor HI trial into a single-arm, open-label study using glucose infusion rate reduction as the primary endpoint and underscored the potential of ersodetug to address severe, refractory hypoglycemia in this population.

The most recent analyst rating on (RZLT) stock is a Hold with a $2.50 price target. To see the full list of analyst forecasts on Rezolute stock, see the RZLT Stock Forecast page.

Rezolute Approves Key Proposals at Annual Meeting

Rezolute, Inc. held its 2026 annual meeting of stockholders on November 19, 2025, where a quorum was present with 66,700,068 shares represented. Key outcomes included the election of directors, ratification of Grant Thornton LLP as the independent accounting firm, approval of executive compensation, and an amendment to the 2021 Stock Incentive Plan to increase available shares. Additionally, an adjournment proposal was authorized to solicit more proxies if needed.

The most recent analyst rating on (RZLT) stock is a Buy with a $17.00 price target. To see the full list of analyst forecasts on Rezolute stock, see the RZLT Stock Forecast page.

Rezolute Highlights Ersodetug Development at Investor Event

On November 10, 2025, Rezolute, Inc. held an investor event to update stakeholders on the Ersodetug development program. The presentation highlighted the significant unmet clinical needs in treating congenital and tumor hyperinsulinism, emphasizing the limitations of current therapies and the potential of Ersodetug to address these challenges. The event underscored Rezolute’s commitment to advancing clinical programs and improving patient outcomes, which could enhance its positioning in the biopharmaceutical market.

The most recent analyst rating on (RZLT) stock is a Buy with a $18.00 price target. To see the full list of analyst forecasts on Rezolute stock, see the RZLT Stock Forecast page.