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BioRestorative Therapies Reports Second Quarter 2024 Financial Results and Provides Business Update

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BioRestorative Therapies (NASDAQ:BRTX) reported its Q2 2024 financial results and provided a business update. Key highlights include:

1. Improved financial performance: Loss from operations decreased 19% YoY to $2.5 million, while net loss improved 28% YoY to $4.0 million ($0.50 per share).

2. Strong cash position: $14.7 million in cash, cash equivalents, and marketable securities as of June 30, 2024, with no outstanding debt.

3. Progress in clinical programs: FDA clearance for protocol amendment in BRTX-100 Phase 2 study; development of novel exosome-based biologic program for obesity.

4. Commercial developments: Exclusive 5-year agreement with Cartessa Aesthetics for BioCosmeceuticals product supply, generating initial revenue in Q2 2024.

5. Intellectual property expansion: Notice of allowance for Japanese patent related to ThermoStem® platform.

BioRestorative Therapies (NASDAQ:BRTX) ha pubblicato i risultati finanziari per il secondo trimestre 2024 e fornito un aggiornamento aziendale. I punti salienti includono:

1. Miglioramento delle performance finanziarie: La perdita dalle operazioni è diminuita del 19% rispetto all'anno precedente a $2,5 milioni, mentre la perdita netta è migliorata del 28% rispetto all'anno precedente a $4,0 milioni ($0,50 per azione).

2. Posizione di cassa solida: $14,7 milioni in contante, equivalenti di cassa e titoli negoziabili al 30 giugno 2024, senza debiti in sospeso.

3. Progressi nei programmi clinici: Approvazione della FDA per la modifica del protocollo nello studio di Fase 2 di BRTX-100; sviluppo di un nuovo programma biologico a base di eseomi per l'obesità.

4. Sviluppi commerciali: Accordo esclusivo di 5 anni con Cartessa Aesthetics per la fornitura di prodotti BioCosmeceuticals, generando entrate iniziali nel secondo trimestre 2024.

5. Espansione della proprietà intellettuale: Avviso di concessione per un brevetto giapponese relativo alla piattaforma ThermoStem®.

BioRestorative Therapies (NASDAQ:BRTX) informó sobre sus resultados financieros del segundo trimestre de 2024 y proporcionó una actualización empresarial. Los puntos destacados incluyen:

1. Mejora en el rendimiento financiero: La pérdida de operaciones disminuyó un 19% interanual a $2.5 millones, mientras que la pérdida neta mejoró un 28% interanual a $4.0 millones ($0.50 por acción).

2. Sólida posición de efectivo: $14.7 millones en efectivo, equivalentes de efectivo y valores negociables al 30 de junio de 2024, sin deudas pendientes.

3. Avances en programas clínicos: Aprobación de la FDA para enmienda de protocolo en el estudio de Fase 2 de BRTX-100; desarrollo de un nuevo programa biológico basado en exosomas para la obesidad.

4. Desarrollos comerciales: Acuerdo exclusivo de 5 años con Cartessa Aesthetics para el suministro de productos BioCosmeceuticals, generando ingresos iniciales en el segundo trimestre de 2024.

5. Expansión de la propiedad intelectual: Aviso de concesión para una patente japonesa relacionada con la plataforma ThermoStem®.

BioRestorative Therapies (NASDAQ:BRTX)는 2024년 2분기 재무 결과를 발표하고 사업 업데이트를 제공했습니다. 주요 내용은 다음과 같습니다:

1. 재무 성과 개선: 운영 손실이 전년 대비 19% 감소하여 250만 달러에 달했으며, 순손실은 전년 대비 28% 개선되어 400만 달러 ($0.50 주당)를 기록했습니다.

2. 강력한 현금 보유: 2024년 6월 30일 기준으로 $1,470만의 현금, 현금성 자산 및 유가증권을 보유하고 있으며, 미지급 부채가 없습니다.

3. 임상 프로그램의 진전: BRTX-100 2상 연구의 프로토콜 수정에 대한 FDA 승인; 비만을 위한 새로운 초소포체 기반 생물학 프로그램 개발.

4. 상업적 발전: BioCosmeceuticals 제품 공급을 위한 Cartessa Aesthetics와의 5년 독점 계약 체결, 2024년 2분기에 초기 수익 창출.

5. 지적 재산 확대: ThermoStem® 플랫폼 관련 일본 특허 승인 통지.

BioRestorative Therapies (NASDAQ:BRTX) a annoncé ses résultats financiers pour le deuxième trimestre 2024 et a fourni une mise à jour commerciale. Les points clés incluent :

1. Amélioration de la performance financière : La perte d'exploitation a diminué de 19 % par rapport à l'année précédente, s'établissant à 2,5 millions de dollars, tandis que la perte nette s'est améliorée de 28 % par rapport à l'année précédente pour atteindre 4,0 millions de dollars (0,50 $ par action).

2. Position de trésorerie solide : 14,7 millions de dollars en liquidités, équivalents de liquidités et titres négociables au 30 juin 2024, sans dettes en cours.

3. Progrès des programmes cliniques : Approbation de la FDA pour la modification du protocole dans l'étude de phase 2 de BRTX-100 ; développement d'un nouveau programme biologique basé sur des exosomes pour l'obésité.

4. Détails commerciaux : Accord exclusif de 5 ans avec Cartessa Aesthetics pour la fourniture de produits BioCosmeceuticals, générant des revenus initiaux au 2e trimestre 2024.

5. Expansion de la propriété intellectuelle : Avis d'octroi pour un brevet japonais lié à la plateforme ThermoStem®.

BioRestorative Therapies (NASDAQ:BRTX) hat seine finanziellen Ergebnisse für das zweite Quartal 2024 veröffentlicht und ein Unternehmensupdate bereitgestellt. Die wichtigsten Highlights sind:

1. Verbesserte finanzielle Leistung: Der Verlust aus dem operativen Geschäft verringerte sich im Jahresvergleich um 19% auf 2,5 Millionen Dollar, während der Nettoverlust im Jahresvergleich um 28% auf 4,0 Millionen Dollar ($0,50 je Aktie) verbessert wurde.

2. Starke Bargeldposition: 14,7 Millionen Dollar in Bargeld, Zahlungsmitteläquivalenten und handelbaren Wertpapieren zum 30. Juni 2024, ohne ausstehende Schulden.

3. Fortschritte in klinischen Programmen: FDA-Zulassung für die Protokolländerung in der BRTX-100-Phase-2-Studie; Entwicklung eines neuartigen exosomenbasierten biologischen Programms gegen Fettleibigkeit.

4. Kommerzielle Entwicklungen: Exklusiver 5-Jahres-Vertrag mit Cartessa Aesthetics über die Lieferung von BioCosmeceuticals-Produkten, was im 2. Quartal 2024 erste Einnahmen generiert.

5. Erweiterung des geistigen Eigentums: Genehmigungsbenachrichtigung für japanisches Patent im Zusammenhang mit der ThermoStem®-Plattform.

Positive
  • 19% year-over-year improvement in loss from operations, decreasing to $2.5 million in Q2 2024
  • 28% year-over-year improvement in net loss, reducing to $4.0 million in Q2 2024
  • Strong cash position of $14.7 million with no outstanding debt as of June 30, 2024
  • FDA clearance for important protocol amendment in BRTX-100 Phase 2 study
  • Development of novel exosome-based biologic program targeting obesity
  • Exclusive 5-year commercial agreement with Cartessa Aesthetics, generating initial product revenue in Q2 2024
  • Notice of allowance for Japanese patent related to ThermoStem® platform, expanding intellectual property estate
Negative
  • Continued operating loss of $2.5 million in Q2 2024
  • Net loss of $4.0 million ($0.50 per share) in Q2 2024
  • Cash used in operating activities of $1.9 million in Q2 2024

Insights

BioRestorative Therapies' Q2 2024 results show promising progress towards profitability. The company reduced its loss from operations by 19% year-over-year to $2.5 million and by 39% sequentially. Net loss improved by 28% to $4.0 million, or $0.50 per share. Notably, BRTX ended Q2 with a strong financial position, holding $14.7 million in cash and equivalents with no outstanding debt.

The company's initial product revenue from its agreement with Cartessa Aesthetics is a positive sign, potentially leading to increased BioCosmeceuticals sales in future periods. However, investors should note that the company is still operating at a loss and sustainable profitability remains a future goal.

BioRestorative's R&D progress is noteworthy. The FDA's clearance of a protocol amendment for the BRTX-100 Phase 2 study, replacing saline with a sham injection in the control arm, enhances trial safety and validity. This could potentially strengthen the study's outcomes and accelerate the development timeline.

The company's expansion into exosome-based biologics for obesity treatment, with plans to file a Drug Master File in Q3 2024, demonstrates diversification of their pipeline. Furthermore, the new Japanese patent for the ThermoStem® platform strengthens their intellectual property position, potentially attracting licensing deals and ensuring market exclusivity.

While these developments are promising, investors should remain cautious as clinical trials and regulatory processes can be lengthy and unpredictable.

MELVILLE, N.Y., Aug. 13, 2024 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a regenerative medicine innovator focused on stem cell-based therapies and products, today reported financial results for the second quarter June 30, 2024 and provided an update on its business.

“We have had an exciting and productive first half of 2004 and are energized by the many potential value enhancing inflection points we see ahead,” said Lance Alstodt, BioRestorative’s Chief Executive Officer. “From an operating perspective, we are thrilled with our second quarter results, as we are seeing initial progress on our path to sustainable profitability.”

Recent Highlights

DEVELOPMENT

  • To support the launch of its new Regenerative Medicine section in July, the prestigious Journal of Translational Medicine named Francisco Silva, BioRestorative’s Chief Scientist and Vice President of Research and Development, as its Section Editor. This peer-reviewed open-access journal had a 2021 impact factor of 8.440, ranking it among the top 3% of journals worldwide, according to Journal Citation Reports.

Disc/Spine Program

  • In April, the Company announced U.S. Food and Drug Administration (“FDA”) clearance of an important amendment to the protocol of the ongoing Phase 2 BRTX-100 study in chronic lumbar disc disease (cLDD), removing saline injection in the control arm of the study and replacing it with a sham injection. This positive change in the protocol brings additional safety to the trial’s subject participants, and helps preclude the possibility of transient clinical outcomes in the control group.
  • BioRestorative continues to work toward achieving completion of patient enrollment in the Phase 2 BRTX-100 study, as well as providing additional preliminary data updates, before the end of 2024.

Metabolic Program

  • In May, the Company revealed the development of a novel exosome-based biologic program targeting obesity. BioRestorative currently anticipates initiating the formal FDA process for this ThermoStem®-based therapeutic candidate by filing a Drug Master File (“DMF”) in the third quarter of 2024. The DMF is expected to facilitate the timely initiation of first-in-human clinical studies.
  • On the heels of that announcement, BioRestorative reported that it had begun to engage in substantive discussions with an undisclosed commercial stage regenerative medicine company with regard to a potential license of BioRestorative’s allogeneic, off-the-shelf ThermoStem® metabolic intellectual property. Those discussions are continuing; however, no assurances can be given that a license agreement will be entered into whether on commercially reasonable terms or otherwise.
  • In July, BioRetorative received a notice of allowance from the Japanese Patent Office for patent application No. 2021-564135 related to the ThermoStem® platform. This, the fifth Japanese patent to issue for the technology platform, covers a method of making three-dimensional brown adipose derived stem cell aggregates in the absence of differentiation medium. The Company believes that continuing to proactively expand its already formidable ThermoStem® intellectual property estate will help drive licensing opportunities and long-term market exclusivity for this core development program.

COMMERCIAL

BioCosmeceuticals

  • In April, the Company entered into an exclusive five (5)-year commercial agreement with Cartessa Aesthetics, LLC (“Cartessa”), pursuant to which BioRestorative will supply pre-set minimum quantities of finished vials of a proprietary cell-based biologic serum to Cartessa annually as private label under Cartessa’s Chronos ExoCR mark.
  • BioRestorative began to derive some initial product revenue from the exclusive supply agreement with Cartessa in the second quarter, and expects that its BioCosmeceuticals product sales revenues will increase in future periods as it executes on its contract and expands its pipeline with Cartessa.

Summary Second Quarter 2024 Results

For the quarter ended June 30, 2024, the Company had a loss from operations of $2.5 million, a 19% year-over-year improvement from the $3.1 million loss for the comparable period of 2023, and a 39% improvement sequentially from the $4.1 million loss in the first quarter of 2024.

The Company’s net loss for the 2024 second quarter was $4.0 million, or $0.50 per share, a 28% year-over-year improvement from the loss of $5.7 million, or $1.47 per share, for the comparable period in 2023.

Cash used in operating activities in the second quarter of 2024 was $1.9 million.

The Company ended the second quarter in a very strong financial position, with cash, cash equivalents, and marketable securities of $14.7 million, with no outstanding debt, as of June 30, 2024.

For complete financial results, please see BioRestorative’s filings at www.sec.gov, and on the Company's website at www.biorestorative.com under "SEC Filing" in the Investors and Media section.

Conference Call Details

BioRestorative will host a conference call to discuss the 2024 second quarter financial results today at 4:30 p.m. ET. The dial-in number for the conference call is 1-877-545-0523 (United States) or 1-973-528-0016 (International); access code 151026. Participants are asked to dial in approximately 10 minutes before the conference call is scheduled to begin. The call can also be accessed via webcast on the Company's website at www.biorestorative.com/investor-relations under “Events.” The webcast will be archived and accessible for approximately 90 days.

About BioRestorative Therapies, Inc.

BioRestorative (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. As described below, our two core clinical development programs relate to the treatment of disc/spine disease and metabolic disorders, and we have also recently begun offering BioCosmeceutical products:

• Disc/Spine Program (brtxDISC): Our lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a person’s own) cultured mesenchymal stem cells collected from the patient’s bone marrow. We intend that the product will be used for the non-surgical treatment of painful lumbosacral disc disorders or as a complementary therapeutic to a surgical procedure. The BRTX-100 production process utilizes proprietary technology and involves collecting a patient’s bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure, BRTX-100 is to be injected by a physician into the patient’s damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. We have commenced a Phase 2 clinical trial using BRTX-100 to treat chronic lower back pain arising from degenerative disc disease.

• Metabolic Program (ThermoStem®): We are developing cell-based therapy candidates to target obesity and metabolic disorders using brown adipose (fat) derived stem cells (“BADSC”) to generate brown adipose tissue (“BAT”), as well as exosomes secreted by BADSC. BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in animals may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes. BADSC secreted exosomes may also impact weight loss.

• BioCosmeceuticals: We operate a commercial BioCosmeceutical platform. Our current commercial product, formulated and manufactured using our cGMP ISO-7 certified clean room, is a cell-based secretome containing exosomes, proteins and growth factors. This proprietary biologic serum has been specifically engineered by us to reduce the appearance of fine lines and wrinkles and bring forth other areas of cosmetic effectiveness. Moving forward, we also intend to explore the potential of expanding our commercial offering to include a broader family of cell-based biologic aesthetic products and therapeutics via Investigational New Drug (IND)-enabling studies, with the aim of pioneering U.S. Food and Drug Administration (FDA) approvals in the emerging BioCosmeceuticals space.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including, without limitation, those set forth in the Company's latest Form 10-K filed with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements.

CONTACT:

Stephen Kilmer
Investor Relations
Direct: (646) 274-3580
Email: skilmer@biorestorative.com


FAQ

What were BioRestorative Therapies' (BRTX) financial results for Q2 2024?

BioRestorative Therapies reported a loss from operations of $2.5 million and a net loss of $4.0 million ($0.50 per share) for Q2 2024. This represents a 19% and 28% year-over-year improvement in operating loss and net loss, respectively.

What is the cash position of BioRestorative Therapies (BRTX) as of June 30, 2024?

BioRestorative Therapies had $14.7 million in cash, cash equivalents, and marketable securities as of June 30, 2024, with no outstanding debt.

What progress has BioRestorative Therapies (BRTX) made in its clinical programs in 2024?

BioRestorative Therapies received FDA clearance for an important protocol amendment in the BRTX-100 Phase 2 study for chronic lumbar disc disease. The company also developed a novel exosome-based biologic program targeting obesity.

Has BioRestorative Therapies (BRTX) entered any commercial agreements in 2024?

Yes, BioRestorative Therapies entered into an exclusive 5-year commercial agreement with Cartessa Aesthetics in April 2024 to supply proprietary cell-based biologic serum, generating initial product revenue in Q2 2024.

BioRestorative Therapies, Inc.

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