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Goldman Small Cap Research Publishes New Research Report on Regen BioPharma, Inc.

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Regen BioPharma (OTCPK:RGBP) has received coverage from Goldman Small Cap Research, highlighting the company's transition from preclinical to clinical stage. The company's lead candidate, HemaXellerate, has received FDA clearance for Phase I clinical trials, targeting severe aplastic anemia in chemotherapy patients - a $1 billion market opportunity.

The company's innovative stem cell-derived therapy aims to address limitations of current treatments, which require matched donors and risk graft-versus-host disease. With 11 patents awarded and 17 pending, Regen's pipeline includes multiple development pathways. The company is positioned for potential Orphan Drug Designation, which could significantly impact its market valuation.

Regen BioPharma (OTCPK:RGBP) ha ottenuto attenzione da parte di Goldman Small Cap Research, che ha evidenziato il passaggio dell'azienda dalla fase preclinica a quella clinica. Il candidato principale della società, HemaXellerate, ha ricevuto l'autorizzazione dalla FDA per gli studi clinici di Fase I, rivolti all'anemia aplastica grave nei pazienti sottoposti a chemioterapia - un'opportunità di mercato da 1 miliardo di dollari.

La terapia innovativa derivata da cellule staminali mira a superare i limiti dei trattamenti attuali, che richiedono donatori compatibili e comportano il rischio di malattia da trapianto contro l'ospite. Con 11 brevetti concessi e 17 in attesa, il portafoglio di sviluppo di Regen comprende diverse vie di sviluppo. L'azienda è in posizione favorevole per ottenere la Designazione di Farmaco Orfano, che potrebbe influenzare significativamente la sua valutazione di mercato.

Regen BioPharma (OTCPK:RGBP) ha recibido cobertura por parte de Goldman Small Cap Research, destacando la transición de la empresa de la etapa preclínica a la clínica. El candidato principal de la compañía, HemaXellerate, ha recibido la aprobación de la FDA para ensayos clínicos de Fase I, dirigidos a la anemia aplásica severa en pacientes con quimioterapia, un mercado con una oportunidad de 1.000 millones de dólares.

La innovadora terapia derivada de células madre de la empresa busca superar las limitaciones de los tratamientos actuales, que requieren donantes compatibles y conllevan riesgo de enfermedad injerto contra huésped. Con 11 patentes otorgadas y 17 en trámite, la cartera de desarrollo de Regen incluye múltiples vías. La compañía está posicionada para una posible Designación de Medicamento Huérfano, lo que podría impactar significativamente su valoración de mercado.

Regen BioPharma (OTCPK:RGBP)는 Goldman Small Cap Research의 주목을 받으며 전임상 단계에서 임상 단계로의 전환을 강조했습니다. 회사의 주력 후보물질인 HemaXellerate는 FDA로부터 1상 임상시험 승인을 받았으며, 화학요법 환자의 중증 재생불량성 빈혈을 대상으로 하는 10억 달러 규모의 시장 기회를 겨냥하고 있습니다.

이 회사의 혁신적인 줄기세포 유래 치료법은 현재 치료법의 한계인 적합한 공여자 필요성과 이식편대숙주병 위험을 해결하는 것을 목표로 합니다. 11건의 특허 승인과 17건의 출원 중인 Regen의 파이프라인에는 다양한 개발 경로가 포함되어 있습니다. 회사는 희귀의약품 지정 가능성에 있어 유리한 위치에 있으며, 이는 시장 가치에 큰 영향을 미칠 수 있습니다.

Regen BioPharma (OTCPK:RGBP) a reçu l'attention de Goldman Small Cap Research, soulignant la transition de l'entreprise de la phase préclinique à la phase clinique. Le principal candidat de la société, HemaXellerate, a obtenu l'autorisation de la FDA pour des essais cliniques de phase I, ciblant l'anémie aplastique sévère chez les patients sous chimiothérapie – une opportunité de marché de 1 milliard de dollars.

La thérapie innovante dérivée de cellules souches vise à pallier les limites des traitements actuels, qui nécessitent des donneurs compatibles et comportent un risque de maladie du greffon contre l'hôte. Avec 11 brevets délivrés et 17 en attente, le pipeline de Regen comprend plusieurs voies de développement. L'entreprise est bien positionnée pour une éventuelle désignation de médicament orphelin, ce qui pourrait avoir un impact significatif sur sa valorisation de marché.

Regen BioPharma (OTCPK:RGBP) hat von Goldman Small Cap Research Aufmerksamkeit erhalten, die den Übergang des Unternehmens von der präklinischen zur klinischen Phase hervorhebt. Der Hauptkandidat des Unternehmens, HemaXellerate, hat die FDA-Freigabe für Phase-I-Studien erhalten und zielt auf schwere aplastische Anämie bei Chemotherapiepatienten ab – eine 1-Milliarde-Dollar-Marktchance.

Die innovative, aus Stammzellen gewonnene Therapie des Unternehmens soll die Einschränkungen aktueller Behandlungen überwinden, die auf passende Spender angewiesen sind und das Risiko einer Graft-versus-Host-Erkrankung bergen. Mit 11 erteilten Patenten und 17 anhängigen umfasst die Pipeline von Regen mehrere Entwicklungswege. Das Unternehmen ist gut positioniert für eine mögliche Orphan-Drug-Designation, die den Marktwert erheblich beeinflussen könnte.

Positive
  • FDA-cleared IND for Phase I trials of HemaXellerate
  • Strong intellectual property portfolio with 11 patents awarded and 17 pending
  • Targeting $1 billion market opportunity in severe aplastic anemia treatment
  • Potential for Orphan Drug Designation
Negative
  • Still in early stages with no clinical trial data yet
  • Currently trading as a penny stock on OTCPK market

Company Set to Make Migration from Preclinical to Clinical Stage

BALTIMORE, MD / ACCESS Newswire / July 17, 2025 / Goldman Small Cap Research, a stock market research firm specializing in the small cap and microcap sectors, announced today that it has published a new research report on Regen BioPharma, Inc. (OTCPK:RGBP), a developer of innovative treatments using autologous cell therapies, RNA and DNA-based immunotherapy and small molecules in the immune-oncology segment. The Goldman report carries a price target. To view and download the new research report, along with disclosures and disclaimers, please visit: https://goldmansmallcapresearch.com/opportunity-research/regen-phase-i/.

Regen BioPharma, Inc. is focused on developing innovative treatments using autologous cell therapies, RNA and DNA-based immunotherapy and small molecules in the immune-oncology segment. The Company seeks to rapidly advance novel technologies through pre-clinical and Phase I/II clinical trials. The Company has an FDA-cleared IND for its Phase I clinical trial candidate HemaXellerate, an innovative stem cell-derived therapy.

In the Opportunity Research report, analyst Rob Goldman reviews this undervalued and underfollowed innovator including upcoming milestones and events, deep pipeline, and valuation drivers.

Migration from Preclinical to Clinical Status

Goldman commented, "Regen is on the cusp of making a major leap from the preclinical biopharma stage to a clinical stage biopharma, which typically serves as core industry valuation driver. The Company's lead candidate, HemaXellerate, is an innovative stem cell-derived therapy and the Company plans to launch a Phase I clinical trial in the coming months. HemaXellerate's primary indication is to treat chemotherapy patients who have developed a potentially terminal side effect, severe aplastic anemia. The only approved therapy is a costly stem cell transplant, which needs a matched donor and can lead to graft-versus-host disease. Still, the Regen therapy represents $1 billion in market size. "

Multiple, Enviable Development Pathways

"Regen could be awarded an Orphan Drug Designation (ODD) for this product, which would be a major coup for the Company," noted Goldman. "Regen is also evaluating expanded applications for this groundbreaking therapy. With two other filed INDs and a deep pipeline Regen is no one-trick pony. The Company has been awarded 11 patents with 17 patents pending."

Upcoming Events Poised to Raise Profile and Valuation

"We believe that these shares are undervalued based on the IP alone. When taking into account Regen's migration to the clinical stage, this status becomes even more pronounced, given the typical market cap assigned to its peers. Our price target reflects a meaningful discount to the typical market caps enjoyed by active Phase I clinical trial peers. However, if the drug is awarded Orphan Drug Designation, our target could prove to be conservative," concluded Goldman.

About Goldman Small Cap Research: Founded in 2009 by former Piper Jaffray analyst and mutual fund manager Rob Goldman, Goldman Small Cap Research produces sponsored and non-sponsored small cap and microcap stock research reports, articles, stock market blogs, and popular investment newsletters.

Goldman Small Cap Research is not in any way affiliated with Goldman Sachs & Co.

This press release contains excerpts of our most recently published company report on Regen BioPharma, Inc. ("The Company"). The information used and statements of fact made have been obtained from sources considered reliable but we neither guarantee nor represent the completeness or accuracy. Goldman Small Cap Research relied solely upon information derived from Regen BioPharma, Inc. The information includes authorized press releases or legal disclosures made in their filings with the U.S. Securities and Exchange Commission http://www.sec.gov.

Separate from the factual content of our update about the Company, we may from time to time include our own opinions about the Company, its business, markets, and opportunities. Any opinions we may offer about the Company are solely our own and are made in reliance upon our rights under the First Amendment to the U.S. Constitution, and are provided solely for the general opinionated discussion of our readers. Our opinions should not be considered to be complete, precise, accurate, or current investment advice. Statements herein may contain forward-looking statements and are subject to significant risks and uncertainties affecting results.

A Goldman Small Cap Research report, update, newsletter, article, trading alert, corporate profile, sector or industry snapshot, podcast interview, or press release is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell the securities mentioned or discussed and is to be used for informational purposes only. Please read all associated full disclosures, disclaimers, and analyst background on our website before investing. Neither Goldman Small Cap Research nor its parent is a registered investment adviser or broker-dealer with FINRA or any other regulatory agency. To download this research report, visit www.goldmansmallcapresearch.com. In 2023, Goldman Small Cap Research was compensated by a third party in the amount of $5,000 for research report production and distribution. Goldman Small Cap Research was compensated $5,000 for the July 2025 report and press release.

Goldman Small Cap Research

Rob Goldman, Analyst
410-800.7980
rob@goldmansmallcapresearch.com

SOURCE: Goldman Small Cap Research



View the original press release on ACCESS Newswire

FAQ

What is Regen BioPharma's (RGBP) lead drug candidate?

Regen BioPharma's lead candidate is HemaXellerate, an innovative stem cell-derived therapy that has received FDA clearance for Phase I clinical trials to treat severe aplastic anemia in chemotherapy patients.

How many patents does Regen BioPharma (RGBP) currently hold?

Regen BioPharma currently holds 11 awarded patents and has 17 patents pending, demonstrating strong intellectual property protection.

What is the market opportunity for Regen BioPharma's (RGBP) HemaXellerate treatment?

The market opportunity for HemaXellerate in treating severe aplastic anemia is estimated at $1 billion.

What advantages does HemaXellerate offer over current treatments for severe aplastic anemia?

HemaXellerate offers potential advantages over current stem cell transplant treatments, which require matched donors and can cause graft-versus-host disease.

What is the current development stage of Regen BioPharma (RGBP)?

Regen BioPharma is transitioning from preclinical to clinical stage, with an FDA-cleared IND for Phase I clinical trials of HemaXellerate.
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