Rezolute (RZLT) AI Stock Analysis

• Market Cap: $269.84M
• Dividend Yield: N/A
• Average Volume (3M): 4.03M
• Price to Earnings (P/E): ―
• Beta (1Y): 1.18
• 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: 2,835,316
• 30 Day Avg. Volume: 4,030,634
• 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: 0.98
• Enterprise Value/Revenue: N/A
• Enterprise Value/Gross Profit: -32.89K
• Enterprise Value/Ebitda: -3.25
• 1Y Price Target: $6.29
• Price Target Upside: 116.15% Upside
• Rating Consensus: Moderate Buy
• Number of Analyst Covering: 9
• EPS Forecast (FY): N/A
• Revenue Forecast (FY): N/A

• Rating: 45 Neutral
• Price Target: $3.00 ▲(3.09% Upside)

Overall score reflects heavy losses and material cash burn despite a low-debt balance sheet. Technicals add downside risk given the price remains below key moving averages and MACD is negative, while valuation is constrained by negative earnings and no dividend support.

Positive Factors

Low Leverage / Financial Flexibility

Rezolute’s very low leverage and meaningful equity expansion provide durable financial flexibility for a clinical-stage biotech. Low debt reduces bankruptcy risk and preserves capacity to raise non-debt capital for trials or partnerships over the next 2–6 months as programs progress.

Clinical Activity and Patient Retention

High trial retention and switch to ersodetug monotherapy indicate real pharmacologic effect and clinical utility beyond statistical endpoints. Durable patient benefit signals stronger adoption potential in rare-disease populations and supports regulatory and commercial positioning long term.

Regulatory Pathway Engagement

Holding Breakthrough Therapy Designation and actively engaging the FDA are structural positives. This status can enable accelerated dialogue, potential faster review paths, and design flexibility for single-arm or surrogate endpoint strategies important for rare-disease approvals.

Negative Factors

High Cash Burn

Sizable and growing negative free cash flow is a durable funding pressure for Rezolute, requiring frequent external financing or partnerships. Over 2–6 months, persistent cash consumption constrains strategic optionality and increases dilution or covenant risk if not addressed.

Pre-Revenue with Widening Losses

Operating without product revenue and with expanding net losses means profitability is distant. This structural reality increases reliance on capital markets and makes long-term sustainability contingent on clinical/regulatory success or durable licensing deals.

Phase 3 Primary Endpoint Failure

Missing primary and key secondary endpoints in a pivotal trial is a fundamental setback. It raises structural uncertainty about approvability and commercial profile, necessitating redesigns or alternative endpoints that can delay or complicate regulatory approval paths.

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

Financial profile is mixed for a development-stage biotech: the balance sheet is strong with very low leverage (debt-to-equity ~0.01), but the company remains pre-revenue with widening net losses (about $74M FY2025; ~$77M TTM) and sustained, growing cash burn (FCF about -$69M FY2025; ~$-71M TTM).

Income Statement

RZLT continues to operate pre-revenue (zero revenue across the periods provided), with persistent and widening losses. Net loss increased from about $20.9M (FY2021) to $74.4M (FY2025 annual) and $77.2M in TTM (Trailing-Twelve-Months), indicating a rising cost base ahead of commercialization. With no revenue, profitability is not yet demonstrated and near-term earnings quality remains weak despite the typical biotech development-stage context.

Balance Sheet

The balance sheet is a clear strength: leverage is very low in recent periods (debt-to-equity ~0.01 in FY2024–FY2025 and TTM), providing financial flexibility. Equity has also expanded meaningfully since FY2023–FY2025, supporting a larger asset base. The key weakness is ongoing negative returns on equity driven by continued net losses (ROE remains deeply negative), which can pressure the capital base over time if losses persist.

Cash Flow

Cash generation is weak, with operating cash flow and free cash flow consistently negative and trending larger in magnitude (from about -$20.4M in FY2021 to -$69.1M in FY2025 annual and -$70.5M in TTM (Trailing-Twelve-Months)). While free cash flow broadly tracks net income (free cash flow to net income ~1.0), the business is clearly consuming cash rather than funding itself internally. Reported free cash flow growth is volatile (including a positive figure in TTM), but the absolute level remains materially negative.

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: 2.91
• 50DMA: Negative
• 100DMA: Negative
• 200DMA: Negative
• MACD: Negative
• RSI: Neutral
• STOCH: Positive

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 2.91 is below the 20-day moving average (MA) of 3.00, below the 50-day MA of 4.30, and below the 200-day MA of 5.94, indicating a bearish trend. The MACD of -0.19 indicates Negative momentum. The RSI at 42.29 is Neutral, neither overbought nor oversold. The STOCH value of 13.50 is Positive, 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
GERN	54 Neutral	$938.38M	-12.23	-29.57%	―	522.13%	62.68%
KOD	54 Neutral	$1.37B	-5.43	-207.92%	―	―	-12.93%
TSHA	53 Neutral	$1.24B	-12.81	-64.93%	―	-36.36%	-945.72%
Sector *	51 Neutral	$7.86B	-0.30	-43.30%	2.27%	22.53%	-2.21%
XNCR	46 Neutral	$823.36M	-6.49	-19.61%	―	38.16%	48.43%
RZLT	45 Neutral	$269.84M	-3.13	-59.23%	―	―	26.65%
ABUS	41 Neutral	$746.22M	-17.49	-45.88%	―	116.64%	47.93%

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.