Executive Summary / Key Takeaways

• Regen BioPharma is an early-stage biotechnology company focused on developing regenerative medical applications, primarily in immune-oncology and autoimmune diseases, leveraging technologies targeting immune modulation like NR2F6 inhibition and various cell/RNA-based therapies.
• The company operates with minimal cash reserves ($1,761 as of March 31, 2025) and a significant accumulated deficit ($21 million), relying heavily on licensing revenue from related parties and facing substantial doubt about its ability to continue as a going concern without significant future funding.
• Recent financial performance shows stable but minimal licensing revenue ($59,065 for Q1 2025), zero research and development expenses in the most recent six-month period, and net losses significantly impacted by non-cash derivative gains/losses.
• RGBP's competitive position is that of a small, capital-constrained player with unproven technology attempting to compete in markets dominated by large, well-funded pharmaceutical giants like Bristol-Myers Squibb (BMY), Merck (MRK), Gilead Sciences (GILD), and Amgen (AMGN), whose established products and scale offer significant financial and operational advantages.
• The investment thesis hinges entirely on the successful clinical development and potential commercialization or licensing of RGBP's early-stage therapeutic candidates, representing a high-risk, high-reward opportunity dependent on overcoming significant funding and execution challenges.

Setting the Scene: Ambition in a Capital-Constrained Landscape

Regen BioPharma, Inc., organized in 2012, set out with an ambitious goal: to develop regenerative medical applications with the potential to address significant unmet needs in areas like immune-oncology and autoimmune diseases. The company's foundational strategy involved identifying promising intellectual property, advancing it through early clinical trial phases (Phase I and/or Phase II), and then seeking to monetize these assets either through sale, licensing, or further development towards Phase III. This model positions Regen as an innovator aiming to de-risk early-stage assets before potentially partnering with larger players or pursuing later-stage development independently.

At the heart of Regen's scientific approach is the focus on modulating the immune system. A key area of interest involves identifying small molecules that can inhibit or express the nuclear receptor NR2F6. The strategic intent behind targeting NR2F6 is its potential dual role: inhibition could lead to immune cell activation for oncology applications, while expression could induce immune cell suppression for autoimmune diseases. This dual potential represents a core technological differentiator, aiming for a versatile platform applicable across different therapeutic areas.

The company's pipeline, though early-stage, reflects this strategy. It includes candidates such as HemaXellarate (a cellular therapeutic), dCellVax (an autologous dendritic cell therapy), tCellVax (a T cell therapy), DiffronC (an in vivo siRNA therapy), and DuroCAR (CAR-T cells). These therapies utilize various modalities, including cell therapy, siRNA, and CAR-T technology, all aimed at leveraging or modulating the immune response. While specific quantifiable performance metrics or clinical trial targets for these candidates are not detailed, the strategic goal is clear: demonstrate sufficient efficacy and safety in early trials to validate the underlying technology and advance the assets.

From its inception, Regen has operated within the challenging biotechnology landscape, characterized by high research and development costs, lengthy development timelines, and significant regulatory hurdles. The company's history includes establishing a wholly-owned subsidiary, KCL Therapeutics, Inc., to which certain intellectual property rights were assigned, and entering into licensing agreements, notably with related party Zander Therapeutics, Inc., for veterinary therapeutic use. These historical steps have shaped the company's structure and revenue streams.

Regen operates in markets dominated by large, established pharmaceutical and biotechnology companies with vast resources, extensive pipelines, and approved products. Companies like Bristol-Myers Squibb, Merck & Co., Gilead Sciences, and Amgen are formidable competitors in immune-oncology and autoimmune therapies. These giants possess significant advantages in scale, manufacturing capabilities, regulatory experience, and financial strength. For instance, BMY and MRK have blockbuster immunotherapy drugs like Opdivo and Keytruda with billions in annual sales and proven clinical efficacy, while GILD has established CAR T therapies like Yescarta. Amgen also holds a strong position in oncology and inflammation.

Against this backdrop of well-resourced competitors, Regen's position is that of a small, early-stage player. Its competitive strategy relies on the potential for its differentiated technologies, such as NR2F6 modulation and specific cell/RNA-based approaches, to offer unique benefits or target underserved niches. For example, the NR2F6 approach aims for a novel mechanism of immune modulation that could potentially offer advantages in specificity or efficacy compared to existing therapies. However, these potential advantages remain unproven in clinical trials, and the company's limited financial resources represent a significant vulnerability in this highly competitive environment.

Recent Performance and Financial Realities

Reviewing the financial performance for the period ended March 31, 2025, provides a clear picture of Regen's current operational and financial state. For the three months ended March 31, 2025, the company reported total net revenue of $59,065, virtually unchanged from $59,064 in the same period of 2024. This revenue was derived from two sources: $27,425 from the related party license agreement with Zander Therapeutics, Inc., and $31,640 from licenses granted to Oncology Pharma, Inc. The six-month figures show a similar pattern, with total net revenue of $118,130 for the period ended March 31, 2025, compared to $118,129 in the prior year, split between $54,850 from Zander and $63,280 from Oncology Pharma. This indicates a stable, albeit minimal, revenue stream primarily from existing licensing arrangements, showing no significant growth.

Operating expenses for the three months ended March 31, 2025, totaled $172,414, an increase from $160,135 in the prior year. This increase was driven primarily by higher Consulting and Professional Fees ($136,566 vs. $93,400) and Rent ($22,500 vs. $17,215). Notably, Research and Development expenses were $0 for the three months ended March 31, 2025, a significant decrease from $40,133 in the same period of 2024. The six-month operating expenses followed a similar trend, totaling $292,857 for the period ended March 31, 2025, a decrease from $341,982 in the prior year. This six-month decrease was largely attributable to the absence of Research and Development expenses ($0 in 2025 vs. $87,661 in 2024), despite increases in Consulting and Professional Fees ($221,192 vs. $200,300) and Rent ($45,000 vs. $32,215). The reduction in R&D spending is a critical operational detail, suggesting a potential pause or shift in internally funded development activities during this period.

The company's net loss was significantly impacted by non-cash items related to derivative liabilities. For the three months ended March 31, 2025, the net loss was $19,354, a substantial improvement from a net loss of $122,454 in the prior year. This was primarily due to a Derivative Gain of $128,963 recognized in the 2025 quarter. However, for the six months ended March 31, 2025, the net loss was $534,739, higher than the $267,387 net loss in the prior year period, driven by a Derivative Expense of $287,053 recognized in the 2025 six-month period. These fluctuations highlight the volatility introduced by accounting for complex financial instruments. Interest expense also increased in the 2025 periods.

Financially, Regen operates with extremely limited liquidity. As of March 31, 2025, the company held only $1,761 in cash. The working capital deficit worsened, increasing by $481,026 from September 30, 2024, to $5.72 million as of March 31, 2025, primarily due to the increase in Derivative Liability.

Net cash used in operating activities for the six months ended March 31, 2025, was $167,609, an improvement from $371,658 in the prior year, mainly due to the decrease in operating expenses (specifically R&D). Net cash provided by financing activities was $168,655, derived from proceeds from notes payable.

These figures underscore the precarious financial position. The company has incurred significant operating losses and negative cash flows since inception, resulting in an accumulated deficit of approximately $21 million as of March 31, 2025. The minimal cash balance and substantial working capital deficit indicate a critical need for external funding to sustain operations and advance its development pipeline.

Strategic Responses and Outlook

Regen's strategic path forward, as outlined by management, is heavily dependent on securing additional capital. The company explicitly states its dependence on obtaining further working capital funding through the sale of equity and/or debt securities to continue executing its development plans and operations. Without this funding, there is substantial doubt about the company's ability to continue as a going concern for the next twelve months.

Recent corporate actions reflect the ongoing efforts to manage the capital structure and address funding needs. The 1-for-1500 reverse stock split in March 2023 aimed to adjust the share structure. More recently, in 2024, the company amended its Certificate of Incorporation to allow for share dividends and subsequently issued significant stock dividends of Series A Preferred Stock and Common Stock. Common stock has also been issued to satisfy debt and compensate for services, illustrating the use of equity as a financing tool.

The company's outlook is thus inextricably linked to its ability to raise capital. While the strategic intent remains to develop its regenerative medicine applications, the pace and feasibility of this development are directly constrained by financial resources. The absence of R&D spending in the most recent reporting period could signal a temporary halt or slowdown in certain development activities, likely due to funding limitations.

No specific quantitative guidance figures for future revenue, expenses, or profitability were provided. The outlook is qualitative, centered on the critical need for funding to simply continue operations and pursue the development pipeline. The underlying assumption for any future progress is the successful procurement of external financing.

Risks and Challenges

Investing in Regen BioPharma involves significant risks, many of which are inherent in early-stage biotechnology companies, compounded by specific financial and operational challenges highlighted in recent filings.

• Going Concern Risk: The most immediate and significant risk is the company's ability to continue operations. With minimal cash and recurring losses and negative cash flows, the company is dependent on raising additional funding, which is not guaranteed. The "substantial doubt about the Company's ability to continue as a going concern" is a critical disclosure.
• Funding Dependence and Dilution: The reliance on selling equity and/or debt securities means future funding efforts will likely result in significant dilution for existing shareholders or unfavorable debt terms.
• Early Stage of Development: None of the company's product candidates have received FDA approval. The path to regulatory approval is long, expensive, and uncertain. There is no assurance that any of the therapies will be successful in clinical trials or gain approval.
• Related Party Transactions: Significant relationships and transactions exist with related parties (Zander Therapeutics, Inc., BST Partners, David Koos). These include licensing revenue, accounts receivable, investments, and notes payable. While disclosed, these relationships can present potential conflicts of interest and impact the company's financial structure and operations.
• Financial Complexity and Volatility: The presence of complex financial instruments like convertible notes with embedded derivatives introduces significant non-cash gains or losses that can cause substantial volatility in reported net income/loss, potentially obscuring underlying operational performance. The derivative liability itself is a significant balance sheet item ($1.69 million as of March 31, 2025) subject to fair value fluctuations.

• Ineffective Internal Controls: The evaluation of the company's disclosure controls and procedures as ineffective as of March 31, 2025, raises concerns about the reliability of financial reporting and internal processes.

These risks collectively present a challenging environment for Regen BioPharma and underscore the speculative nature of an investment in the company.

Competitive Standing in the Biotech Arena

Regen BioPharma operates in a highly competitive biotechnology sector. While its focus on specific immune modulation targets like NR2F6 and its diverse pipeline modalities (cell, RNA, small molecule) offer potential avenues for differentiation, the company's competitive standing is significantly impacted by its scale and financial health relative to industry leaders.

Compared to large-cap competitors like BMY, MRK, GILD, and AMGN, Regen is orders of magnitude smaller in terms of revenue, market capitalization, and operational infrastructure. These larger companies benefit from economies of scale in R&D, manufacturing, and commercialization. They have extensive sales forces, established relationships with healthcare providers and payers, and diversified revenue streams that can fund ongoing research and absorb clinical trial failures. Their financial metrics, such as high gross and operating margins (e.g., BMY's 75% gross margin, MRK's 78%, GILD's 80%, AMGN's 75%), strong cash flow generation (billions annually), and positive revenue growth (3-8% for these peers in 2023), stand in stark contrast to Regen's minimal revenue, negative margins, and negative operating cash flow.

Regen's potential competitive advantage lies primarily in the novelty of its specific technological approaches, such as targeting NR2F6. If successful in clinical trials, these therapies could potentially offer superior efficacy, reduced side effects, or address patient populations not adequately served by existing treatments. For example, a therapy that achieves more precise immune cell activation or suppression could theoretically lead to better outcomes with lower toxicity compared to broader-acting immunotherapies. However, this remains a theoretical advantage until validated by robust clinical data. The lack of quantifiable performance data or comparative studies makes it impossible to definitively assess the magnitude of this potential technological edge against competitors' proven therapies.

Furthermore, the competitive landscape is dynamic, with larger players constantly investing heavily in R&D, pursuing acquisitions, and forming partnerships to expand their pipelines and maintain market share. Industry trends, such as the increasing adoption of mRNA technology, could potentially favor companies like Regen pursuing such modalities, but regulatory complexities and the need for significant capital investment to scale production and conduct large-scale trials remain substantial barriers that favor the larger, better-funded competitors.

Regen's customer base for its current licensing revenue includes a related party (Zander) and one non-related party (Oncology Pharma). This limited customer base and reliance on licensing rather than direct product sales highlight the early stage of the business model and its dependence on the success and performance of its licensees, particularly the related party, which also features prominently in the company's debt structure. Supplier dynamics, primarily related to research and development activities and general operations, are also influenced by the company's limited financial resources, potentially impacting its ability to secure necessary resources or services compared to larger competitors.

In essence, Regen's competitive position is that of a technology-driven startup challenging established giants. Its success hinges on its ability to translate its early-stage scientific concepts into clinically validated therapies, a process that requires substantial capital and flawless execution, neither of which is currently assured given the company's financial state.

Conclusion

Regen BioPharma represents a high-risk, high-reward investment proposition rooted in the potential of its early-stage regenerative medicine technologies targeting immune modulation. The company possesses a strategic vision focused on addressing significant diseases in immune-oncology and autoimmunity through novel approaches like NR2F6 inhibition and various cell and RNA-based therapies.

However, the path forward is fraught with challenges. The company operates with minimal cash reserves, a significant accumulated deficit, and a dependence on external funding that casts substantial doubt on its ability to continue as a going concern. Recent financial results reflect stable but minimal licensing revenue, a concerning absence of R&D spending in the latest period, and volatility from complex financial instruments.

In a competitive landscape dominated by well-funded pharmaceutical powerhouses with established products and vast resources, Regen's potential technological differentiation is its primary lever. Yet, this advantage remains unproven in clinical settings. The company's lack of scale and precarious financial position make it vulnerable to the competitive pressures exerted by its larger rivals.

For investors, the core narrative is one of a speculative bet on early science overcoming significant financial and execution hurdles in a highly competitive market. The investment thesis is entirely contingent on the company's ability to successfully raise capital, advance its pipeline through clinical trials, and ultimately demonstrate the value of its technology, either through licensing, sale, or successful commercialization. Until then, the risks associated with funding, development uncertainty, and operational challenges loom large, defining RGBP as a high-stakes play in the biotechnology arena.