Regulus (RGLS) AI Stock Analysis

• Market Cap: $113.28M
• Dividend Yield: N/A
• Average Volume (3M): 1.66M
• Price to Earnings (P/E): ―
• Beta (1Y): 1.03
• Revenue Growth: N/A
• EPS Growth: 44.85%
• Country: US
• Employees: 34
• Sector: Healthcare
• Sector Strength: 74
• Industry: Biotechnology
• EPS (TTM): -0.88
• Shares Outstanding: 66,243,385
• 10 Day Avg. Volume: 4,400,308
• 30 Day Avg. Volume: 1,662,911
• PEG Ratio: N/A
• Price to Book (P/B): N/A
• Price to Sales (P/S): N/A
• Price to Cash Flow (P/CF): -1.90
• P/FCF Ratio: 0.00
• Enterprise Value/Market Cap: N/A
• Enterprise Value/Revenue: N/A
• Enterprise Value/Gross Profit: N/A
• Enterprise Value/Ebitda: N/A
• 1Y Price Target: $12.75
• Price Target Upside: 645.61% Upside
• Rating Consensus: Strong Buy
• Number of Analyst Covering: 5

Regulus' overall score reflects the severe challenges in revenue generation and profitability, which weigh heavily on its financial performance score. However, the recent positive clinical trial results and bullish technical indicators provide a brighter outlook, suggesting potential for future growth. The lack of current earnings and profitability, as well as reliance on external financing, remain significant concerns.

Positive Factors

Clinical Trials

The impressive results in early clinical trials of farabursen indicate a promising future if further trials confirm these findings.

FDA Alignment

The accelerated approval pathway is in alignment with the FDA, which has agreed to the key components of the Phase 3 trial design.

Market Potential

Farabursen's potential to be prescribed to a larger proportion of patients compared to tolvaptan suggests strong market acceptance if clinical benefits are confirmed.

Negative Factors

Efficacy Uncertainty

The observed efficacy on reducing htTKV growth rate at three months could be further strengthened at 12 months, supporting potential accelerated approval.

Financial Concerns

Cash remains a question with the company ending the fourth quarter of 2024 with $75.8M in cash, with runway into early 2026.

Regulus Business Overview & Revenue Model

Company Description

Regulus Therapeutics Inc., a clinical stage biopharmaceutical company, engages in the discovery and development of drugs that targets microRNAs to treat a range of diseases in the United States. Its product candidates include RG-012, an anti-miR targeting miR-21 that is in Phase II clinical trial for the treatment of Alport syndrome, a life-threatening kidney disease; and RGLS8429, an anti-miR targeting miR-17, which is in Phase 1b clinical study for the treatment of autosomal dominant polycystic kidney disease. The company is also developing a pipeline of preclinical drug products for target organ-selective delivery strategies. Regulus Therapeutics Inc. was incorporated in 2007 and is headquartered in San Diego, California.

How the Company Makes Money

Regulus Therapeutics makes money through a combination of funding from strategic collaborations, partnerships, and potential revenue from the commercialization of its drug candidates. The company engages in partnerships with larger pharmaceutical companies to co-develop and commercialize its therapeutic products, which often include upfront payments, milestone payments, and royalties on sales. Additionally, Regulus may receive grants and funding from research institutions to support its development programs. As the company advances its pipeline products through clinical trials and towards market approval, successful commercialization of these therapies would become a significant revenue stream.

Regulus Financial Statement Overview

Summary

Regulus faces severe revenue generation challenges, reflected in its income statement with no recent sales. The strong equity position offers some stability, but persistent losses and negative cash flows threaten long-term viability. External financing is currently bridging cash needs, but a strategic pivot to generate revenue is critical.

Income Statement

Regulus shows no revenue in the latest periods, indicating significant challenges in generating sales. The company has consistently reported negative net income, reflective of high operational costs relative to nonexistent revenue. Without revenue growth or profitability, financial sustainability is in question.

Balance Sheet

The company maintains a strong equity position with a high equity ratio, indicating financial stability despite operational losses. Regulus has reduced its total liabilities significantly over time, decreasing financial risk. However, the absence of revenue and ongoing losses pose a risk to future equity sustainability.

Cash Flow

Operating cash flow remains deeply negative, signaling ongoing cash burn without revenue support. Free cash flow has worsened, reflecting increasing operational cash deficits. Financing activities provide temporary relief, but reliance on external funding is unsustainable long-term.

Breakdown
Dec 2024	Dec 2023	Dec 2022	Dec 2021	Dec 2020
Income Statement		Total Revenue
0.00	0.00	0.00	0.00	10.01M
	Gross Profit
0.00	-21.15M	-122.00K	-459.00K	9.99M
	EBIT
-50.04M	-31.11M	-28.24M	-27.82M	-14.15M
	EBITDA
-45.85M	-30.88M	-28.12M	-27.36M	-13.46M
	Net Income Common Stockholders
-46.36M	-30.04M	-28.32M	-27.81M	-15.26M
Balance Sheet		Cash, Cash Equivalents and Short-Term Investments
75.78M	23.77M	39.16M	60.38M	31.09M
	Total Assets
84.18M	30.75M	46.72M	68.45M	37.60M
	Total Debt
274.00K	2.39M	6.28M	7.09M	4.65M
	Net Debt
-38.25M	-21.38M	-17.95M	-53.29M	-26.43M
	Total Liabilities
7.77M	9.56M	13.43M	13.50M	11.58M
	Stockholders Equity
76.41M	21.19M	33.29M	54.96M	26.03M
Cash Flow		Free Cash Flow
-42.01M	-27.38M	-25.89M	-24.38M	-12.55M
	Operating Cash Flow
-41.67M	-26.77M	-25.53M	-24.13M	-12.54M
	Investing Cash Flow
-35.98M	14.49M	-15.12M	-251.00K	-11.00K
	Financing Cash Flow
92.42M	11.82M	4.49M	53.74M	9.51M

Regulus Technical Analysis

• Technical Analysis Sentiment: Positive
• Last Price: 1.71
• 50DMA: Positive
• 100DMA: Positive
• 200DMA: Positive
• MACD: Negative
• RSI: Neutral
• STOCH: Neutral

Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For RGLS, the sentiment is Positive. The current price of 1.71 is above the 20-day moving average (MA) of 1.54, above the 50-day MA of 1.37, and above the 200-day MA of 1.53, indicating a bullish trend. The MACD of 0.09 indicates Negative momentum. The RSI at 67.52 is Neutral, neither overbought nor oversold. The STOCH value of 60.68 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for RGLS.

Regulus Peers Comparison

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
SRPT	66 Neutral	$5.40B	23.35	19.71%	―	52.97%	―
RGLS	53 Neutral	$113.28M	―	-95.00%	―	―	44.85%
ALNY	50 Neutral	$30.30B	―	-414.62%	―	22.97%	38.54%
ARWR	50 Neutral	$1.62B	―	-600.68%	―	-98.62%	-86.21%
IONS	49 Neutral	$4.38B	―	-93.03%	―	-10.48%	-18.79%
MRNA	48 Neutral	$10.29B	―	-28.77%	―	-52.75%	25.00%
Sector *	48 Neutral	$6.36B	1.24	-44.94%	2.70%	18.33%	1.47%

Regulus Corporate Events

Regulus Announces Positive Phase 1b Study Results

On March 27, 2025, Regulus Therapeutics Inc. announced positive topline results from the fourth cohort of its Phase 1b study of farabursen for ADPKD treatment. The study showed that the 300 mg fixed dose of farabursen effectively halted the growth of total kidney volume (htTKV) and demonstrated a favorable safety profile. The results suggest that farabursen could significantly impact disease progression by limiting cyst growth, and the data supports the selection of this dose for an upcoming Phase 3 trial.