Regulus Therapeutics Inc. (RGLS) Bundle
A Brief History of Regulus Therapeutics Inc.
Regulus Therapeutics Inc. has been a prominent player in the biopharmaceutical sector, focusing on discovering and developing innovative medicines targeting microRNAs. As of 2024, the company has undergone significant financial and operational developments.
Financial Performance Overview
For the nine months ended September 30, 2024, Regulus reported total operating expenses of $36.3 million, a notable increase from $22.8 million during the same period in 2023. This increase is attributed mainly to higher research and development expenses, which reached $25.7 million compared to $15.4 million in 2023.
| Period | Operating Expenses (in thousands) | Research and Development Expenses (in thousands) | General and Administrative Expenses (in thousands) |
|---|---|---|---|
| 9 Months Ended September 30, 2024 | $36,294 | $25,695 | $10,599 |
| 9 Months Ended September 30, 2023 | $22,809 | $15,389 | $7,420 |
Cash Flow Analysis
As of September 30, 2024, Regulus reported cash, cash equivalents, and investments totaling $87.3 million. During the nine months ended September 30, 2024, the company generated net cash provided by financing activities of $92.4 million, primarily from a private placement offering.
| Cash Flow Activity | 2024 (in thousands) | 2023 (in thousands) |
|---|---|---|
| Net cash provided by operating activities | $(29,828) | $(20,643) |
| Net cash (used in) provided by investing activities | $(59,983) | $9,559 |
| Net cash provided by financing activities | $92,417 | $12,689 |
| Total cash flow | $2,606 | $1,605 |
Shareholder Equity and Stock Issuance
As of September 30, 2024, Regulus had 65,500,134 shares of common stock outstanding, up from 20,222,672 shares at the end of 2023. The company raised approximately $93.9 million in net proceeds from the sale of common stock and non-voting convertible preferred stock in March 2024, which significantly bolstered its equity position.
| Equity Metrics | September 30, 2024 | December 31, 2023 |
|---|---|---|
| Common Stock Outstanding | 65,500,134 | 20,222,672 |
| Additional Paid-In Capital | $633,394 | $534,375 |
| Accumulated Deficit | $(546,780) | $(513,213) |
Research and Development Focus
Regulus continues to invest heavily in research and development, with expenses of $11.3 million for the third quarter of 2024, compared to $5.5 million in the same quarter of 2023. This reflects the company's commitment to advancing its clinical and preclinical pipeline, particularly in its ADPKD program.
| R&D Expenses Breakdown | Q3 2024 (in thousands) | Q3 2023 (in thousands) |
|---|---|---|
| Personnel and Internal Expenses | $2,949 | $2,189 |
| Third-Party and Outsourced Expenses | $7,309 | $2,952 |
| Non-Cash Stock-Based Compensation | $1,018 | $311 |
As of September 30, 2024, Regulus has incurred approximately $456.4 million in total research and development expenses since its inception.
A Who Owns Regulus Therapeutics Inc. (RGLS)
Shareholder Composition
As of September 30, 2024, Regulus Therapeutics Inc. had the following ownership structure:
| Shareholder Type | Shares Owned | Percentage Ownership |
|---|---|---|
| Common Stock Outstanding | 65,500,134 | 100% |
| Convertible Preferred Stock (Class A-1) | 257,000 | 0.39% |
| Convertible Preferred Stock (Class A-2) | 1,331,000 | 2.03% |
| Convertible Preferred Stock (Class A-3) | 259,000 | 0.39% |
| Convertible Preferred Stock (Class A-4) | 3,726,000 | 5.69% |
| Convertible Preferred Stock (Class A-5) | 14,083,000 | 21.5% |
| Convertible Preferred Stock (Class A-6) | 17,392,000 | 26.56% |
Major Shareholders
The major shareholders of Regulus Therapeutics as of 2024 include:
- Stelios Papadopoulos, Ph.D. – Chairman of the Board, purchased 250,000 shares for $0.4 million in March 2024.
- Institutional Investors – Various accredited institutional investors participated in recent private placements, including a total of approximately $15 million raised in 2023 and $93.9 million in 2024.
Stock Performance
The stock performance of Regulus Therapeutics has been influenced by recent financing activities:
- As of September 30, 2024, Regulus raised approximately $530.1 million from equity and convertible debt securities since inception.
- In 2024, the company completed a PIPE transaction, raising net proceeds of $93.9 million.
Financial Overview
Key financial metrics as of September 30, 2024 include:
| Metric | Value |
|---|---|
| Cash and Cash Equivalents | $26.4 million |
| Total Liabilities | $6.958 million |
| Accumulated Deficit | ($546.8 million) |
| Total Stockholders' Equity | $86.8 million |
Convertible Preferred Stock
The following convertible preferred stock classes were outstanding as of September 30, 2024:
| Class | Shares Outstanding | Conversion Ratio |
|---|---|---|
| Class A-1 | 257,000 | 1:1 |
| Class A-2 | 1,331,000 | 1:1 |
| Class A-3 | 259,000 | 1:1 |
| Class A-4 | 3,726,000 | 1:1 |
| Class A-5 | 140,827 | 100:1 |
| Class A-6 | 173,915 | 1:1 |
Recent Transactions
Recent stock transactions include:
- April 2023: Issued 2,615,536 shares of common stock at $0.9001 per share, raising approximately $15 million.
- March 2024: Issued 250,000 shares to Stelios Papadopoulos for $0.4 million.
Market Presence
As of November 1, 2024, Regulus Therapeutics was listed on NASDAQ with a total market capitalization that fluctuated based on stock performance post-financing activities.
Regulus Therapeutics Inc. (RGLS) Mission Statement
Overview of Mission Statement
The mission of Regulus Therapeutics Inc. is to leverage its expertise in microRNA biology to develop innovative therapeutics that address significant unmet medical needs. The company focuses on advancing its proprietary microRNA product platform to create transformative treatments for patients suffering from serious diseases.
Financial Performance Metrics
As of September 30, 2024, Regulus Therapeutics reported the following financial metrics:
| Metric | Value |
|---|---|
| Total cash, cash equivalents, and investments | $87.3 million |
| Net loss for the nine months ended September 30, 2024 | $(33.6 million) |
| Research and development expenses for the nine months ended September 30, 2024 | $25.7 million |
| General and administrative expenses for the nine months ended September 30, 2024 | $10.6 million |
| Total operating expenses for the nine months ended September 30, 2024 | $36.3 million |
| Net cash used in operating activities for the nine months ended September 30, 2024 | $(29.8 million) |
| Net cash provided by financing activities for the nine months ended September 30, 2024 | $92.4 million |
Research and Development Focus
Regulus Therapeutics is actively engaged in developing RGLS8429, a novel oligonucleotide for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD). The company has shown positive top-line data from clinical trials, indicating a favorable safety profile and improvements in kidney function metrics.
Clinical Development Updates
As of 2024, key updates from the clinical trials include:
- Completion of the Phase 1 single-ascending dose study in healthy volunteers.
- Initiation of the Phase 1b multiple-ascending dose study for RGLS8429 in adult patients with ADPKD.
- Positive topline results from the third cohort of patients treated with RGLS8429.
Investment and Funding History
Since its inception through September 30, 2024, Regulus Therapeutics has raised significant capital through various means:
| Funding Source | Amount |
|---|---|
| Sale of equity and convertible debt securities | $530.1 million |
| Collaborations (upfront payments, research funding, milestones) | $101.8 million |
| Net proceeds from Term Loan | $19.8 million |
Stockholder Equity and Shares Outstanding
As of September 30, 2024, the company's stockholder equity and shares outstanding are as follows:
| Category | Value |
|---|---|
| Common stock outstanding | 65,500,134 shares |
| Accumulated deficit | $(546.8 million) |
| Total stockholders’ equity | $86.8 million |
Challenges and Future Outlook
Regulus Therapeutics faces several challenges, including the need for additional capital to fund ongoing operations and the potential volatility in equity markets that could affect future fundraising efforts. The company aims to continue advancing its clinical programs while navigating these financial hurdles.
How Regulus Therapeutics Inc. (RGLS) Works
Company Overview
Regulus Therapeutics Inc. (RGLS) is focused on developing therapeutics based on microRNA technology. As of September 30, 2024, the company has incurred significant losses, with an accumulated deficit of approximately $546.8 million since its inception.
Financial Performance
For the nine months ended September 30, 2024, Regulus reported a net loss of $33.6 million, compared to a net loss of $22.0 million for the same period in 2023. This marks an increase in losses attributed to higher research and development expenses.
| Financial Metric | Q3 2024 | Q3 2023 | 9M 2024 | 9M 2023 |
|---|---|---|---|---|
| Net Loss | $14.1 million | $7.8 million | $33.6 million | $22.0 million |
| Research & Development Expenses | $11.3 million | $5.5 million | $25.7 million | $15.4 million |
| General & Administrative Expenses | $3.9 million | $2.6 million | $10.6 million | $7.4 million |
| Cash, Cash Equivalents & Investments | $87.3 million | N/A | $87.3 million | N/A |
Product Development Pipeline
Regulus is advancing its lead product candidate, RGLS8429, for Autosomal Dominant Polycystic Kidney Disease (ADPKD). The FDA accepted the Investigational New Drug Application for RGLS8429 in May 2022, and the company has since initiated multiple clinical studies.
Clinical Trials and Results
As of September 30, 2024, Regulus has completed several cohorts in its Phase 1b clinical trial for RGLS8429. The third cohort included 16 subjects receiving 3 mg/kg of RGLS8429, which showed positive results without safety concerns.
Research and Development Expenses
Research and development expenses for the nine months ended September 30, 2024, amounted to $25.7 million, reflecting a significant increase from $15.4 million in the prior year. This increase is primarily due to ongoing clinical trials and higher stock-based compensation.
Liquidity and Capital Resources
As of September 30, 2024, Regulus had cash, cash equivalents, and investments totaling $87.3 million. The company raised approximately $93.9 million in net proceeds from a private placement in March 2024.
Debt Obligations
Regulus had a Term Loan that fully matured on May 1, 2024. The loan bore interest at a floating rate, and all amounts under the Term Loan were paid off as of the maturity date.
Equity Structure
As of September 30, 2024, Regulus had 65,500,134 shares of common stock outstanding. The company has utilized various equity financing strategies to support its operations.
| Equity Metric | September 30, 2024 | December 31, 2023 |
|---|---|---|
| Common Stock Outstanding | 65,500,134 shares | 20,222,672 shares |
| Accumulated Deficit | $(546.8 million) | $(513.2 million) |
| Total Stockholders' Equity | $86.8 million | $21.2 million |
Conclusion on Business Viability
Regulus Therapeutics continues to face substantial financial challenges, including significant net losses and the need for ongoing capital to fund its research and development activities. The success of its product candidates and the ability to secure further financing will be crucial for its future operations.
How Regulus Therapeutics Inc. (RGLS) Makes Money
Revenue Sources
Regulus Therapeutics Inc. primarily generates revenue through collaborations, equity financing, and potential future product sales. Since inception through September 30, 2024, the company has received:
- $530.1 million from the sale of equity and convertible debt securities.
- $101.8 million from collaborations, including upfront payments, research funding, and milestone achievements.
- $19.8 million in net proceeds from a Term Loan.
Financial Overview
As of September 30, 2024, Regulus had cash, cash equivalents, and investments totaling $87.3 million. The company reported a net loss of $33.6 million for the nine months ended September 30, 2024, compared to a net loss of $22.0 million for the same period in 2023. The accumulated deficit stood at $546.8 million at the end of the reporting period.
| Financial Metric | 2024 (Nine Months) | 2023 (Nine Months) |
|---|---|---|
| Net Loss | $33.6 million | $22.0 million |
| Cash, Cash Equivalents, and Investments | $87.3 million | N/A |
| Accumulated Deficit | $546.8 million | $513.2 million |
Research and Development Expenses
Regulus focuses heavily on research and development (R&D), with expenses amounting to $25.7 million for the nine months ended September 30, 2024, compared to $15.4 million for the same period in 2023. This increase is largely due to advancing clinical and preclinical programs, particularly for the product candidate RGLS8429, aimed at treating Autosomal Dominant Polycystic Kidney Disease (ADPKD).
| Expense Type | 2024 (Nine Months) | 2023 (Nine Months) |
|---|---|---|
| Research and Development Expenses | $25.7 million | $15.4 million |
| General and Administrative Expenses | $10.6 million | $7.4 million |
Product Development and Clinical Trials
Regulus's primary product candidate, RGLS8429, has been in clinical development since the second quarter of 2022. The company has made significant progress, including:
- Completion of a Phase 1 single-ascending dose study.
- Initiation of a Phase 1b multiple-ascending dose study.
- Positive top-line data reported in September 2023 demonstrating favorable safety and tolerability.
Equity Financing
In March 2024, Regulus raised approximately $93.9 million in net proceeds through the sale of common stock and non-voting convertible preferred stock. This financing is crucial for sustaining operations and funding ongoing R&D activities.
| Financing Activity | Amount |
|---|---|
| Net Proceeds from 2024 PIPE | $93.9 million |
| Net Proceeds from 2023 PIPE | $14.0 million |
Future Outlook
Regulus anticipates that continued investment in R&D will be necessary to achieve regulatory approval for its product candidates. Future revenues will depend on:
- Successful completion of clinical trials.
- Regulatory approvals.
- Market acceptance of any approved products.
With no revenues generated from product sales to date, Regulus will need to secure additional funding through equity or collaboration agreements to support its ongoing operations and product development efforts.
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Resources:
- Regulus Therapeutics Inc. (RGLS) Financial Statements – Access the full quarterly financial statements for Q3 2024 to get an in-depth view of Regulus Therapeutics Inc. (RGLS)' financial performance, including balance sheets, income statements, and cash flow statements.
- SEC Filings – View Regulus Therapeutics Inc. (RGLS)' latest filings with the U.S. Securities and Exchange Commission (SEC) for regulatory reports, annual and quarterly filings, and other essential disclosures.