IN8bio Announces Pricing of $12.4 Million Private Placement
IN8bio, Inc. (Nasdaq: INAB) has announced a $12.4 million private placement to fund its current operating plan into 2026. The financing will support the ongoing expansion cohorts in the Phase 1 trial of INB-100 for patients with Acute Myeloid Leukemia (AML). The private placement includes the sale of 25,759,595 shares of common stock, pre-funded warrants for 5,646,853 shares, and warrants to purchase up to 31,406,448 shares.
The proceeds will enable IN8bio to increase enrollment to approximately 25 patients in the expansion cohort at the recommended Phase 2 dose, with completion expected in the first half of 2025. Long-term follow-up results are anticipated in late 2025 and 2026. The company also plans to add a parallel control cohort to assess leukemia patients and compare INB-100 treatment to standard haplotransplantation.
IN8bio, Inc. (Nasdaq: INAB) ha annunciato un placement privato di 12,4 milioni di dollari per finanziare il proprio piano operativo attuale fino al 2026. Il finanziamento supporterà le coorti di espansione in corso nella fase 1 della sperimentazione di INB-100 per pazienti con Leucemia Mieloide Acuta (AML). Il placement privato include la vendita di 25.759.595 azioni di azioni ordinarie, warrant pre-finanziati per 5.646.853 azioni e warrant per acquistare fino a 31.406.448 azioni.
I proventi permetteranno a IN8bio di aumentare l'arruolamento a circa 25 pazienti nella coorte di espansione alla dose raccomandata della fase 2, con completamento previsto nella prima metà del 2025. I risultati del follow-up a lungo termine sono attesi entro la fine del 2025 e nel 2026. L'azienda prevede anche di aggiungere una coorte di controllo parallela per valutare i pazienti affetti da leucemia e confrontare il trattamento con INB-100 con la trapiantazione standard di haplo-identico.
IN8bio, Inc. (Nasdaq: INAB) ha anunciado un placement privado de 12.4 millones de dólares para financiar su plan operativo actual hasta 2026. La financiación apoyará las cohortes de expansión en curso en la prueba de fase 1 de INB-100 para pacientes con Leucemia Mieloide Aguda (LMA). El placement privado incluye la venta de 25,759,595 acciones de acciones ordinarias, warrants pre-financiados para 5,646,853 acciones y warrants para comprar hasta 31,406,448 acciones.
Los fondos permitirán a IN8bio aumentar la inscripción a aproximadamente 25 pacientes en la cohorte de expansión a la dosis recomendada de fase 2, con finalización esperada en la primera mitad de 2025. Se anticipan resultados de seguimiento a largo plazo a finales de 2025 y 2026. La empresa también planea añadir una cohorte de control paralela para evaluar a los pacientes con leucemia y comparar el tratamiento INB-100 con el trasplante haploidéntico estándar.
IN8bio, Inc. (Nasdaq: INAB)는 2026년까지 현재 운영 계획을 지원하기 위해 1,240만 달러의 사모투자를 발표했습니다. 이 자금은 급성 골수성 백혈병(AML) 환자에 대한 INB-100의 1상 시험에서 진행 중인 확장 코호트를 지원합니다. 사모투자는 25,759,595주의 보통주, 5,646,853주에 대한 선불 워런트, 최대 31,406,448주를 매입할 수 있는 워런트를 포함합니다.
이 자금은 IN8bio가 확장 코호트에서 약 25명의 환자를 모집할 수 있도록 해주며, 2상 권장 용량에서 모집이 예상됩니다. 이는 2025년 상반기 내에 완료될 것으로 보입니다. 장기 추적 결과는 2025년 말과 2026년에 예상됩니다. 회사는 또한 백혈병 환자를 평가하기 위해 병행 대조군을 추가하여 INB-100 치료를 표준 해플로 이식과 비교할 계획입니다.
IN8bio, Inc. (Nasdaq: INAB) a annoncé une placement privé de 12,4 millions de dollars pour financer son plan opérationnel actuel jusqu'en 2026. Le financement soutiendra les cohortes d'expansion en cours dans l'essai de phase 1 d'INB-100 pour les patients atteints de leucémie myéloïde aiguë (LMA). Le placement privé comprend la vente de 25,759,595 actions ordinaires, des bons de souscription préfinancés pour 5,646,853 actions et des bons de souscription pour acheter jusqu'à 31,406,448 actions.
Les produits permettront à IN8bio d'augmenter l'inscription à environ 25 patients dans la cohorte d'expansion à la dose recommandée de la phase 2, avec un achèvement prévu dans la première moitié de 2025. Les résultats du suivi à long terme sont anticipés fin 2025 et en 2026. La société prévoit également d'ajouter une cohorte de contrôle parallèle pour évaluer les patients atteints de leucémie et comparer le traitement INB-100 à la transplantation haplo-identique standard.
IN8bio, Inc. (Nasdaq: INAB) hat eine Privatplatzierung in Höhe von 12,4 Millionen US-Dollar angekündigt, um seinen aktuellen Betriebsplan bis 2026 zu finanzieren. Die Finanzierung wird die laufenden Erweiterungs-Kohorten in der Phase-1-Studie von INB-100 für Patienten mit akuter myeloischer Leukämie (AML) unterstützen. Die Privatplatzierung umfasst den Verkauf von 25.759.595 Aktien von Stammaktien, vorfinanzierten Warrants für 5.646.853 Aktien und Warrants zum Kauf von bis zu 31.406.448 Aktien.
Die Erlöse ermöglichen es IN8bio, die Einschreibung auf etwa 25 Patienten in der Erweiterungskohorte bei der empfohlenen Phase-2-Dosis zu erhöhen, wobei der Abschluss für die erste Hälfte von 2025 erwartet wird. Langfristige Nachverfolgergebnisse werden Ende 2025 und 2026 erwartet. Das Unternehmen plant auch, eine parallele Kontrollkohorte hinzuzufügen, um Leukämiepatienten zu bewerten und die Behandlung mit INB-100 mit der standardmäßigen Haplo-Transplantation zu vergleichen.
- Secured $12.4 million in private placement funding
- Extended cash runway to fund operations into 2026
- Expanding Phase 1 trial of INB-100 for AML patients
- Increasing enrollment to 25 patients in expansion cohort
- Adding parallel control cohort to strengthen clinical data
- Potential dilution for existing shareholders due to new share issuance
- Warrants issued at a lower price than current stock value
Insights
This private placement of
The deal structure, combining common stock, pre-funded warrants and Series C Warrants at a
For a company with a market cap of just
The expansion of IN8bio's Phase 1 trial for INB-100 in AML patients is a critical development. Increasing the target enrollment to approximately 25 patients at the recommended Phase 2 dose will provide more robust data on efficacy and safety. The addition of a parallel control cohort is particularly noteworthy, as it will allow for a more rigorous comparison between INB-100 and standard haplotransplantation.
The timeline for completion of enrollment in H1 2025 and long-term follow-up results in late 2025 and 2026 aligns well with the extended cash runway. This data could be pivotal in determining the potential of gamma-delta T cell therapies in AML treatment. The focus on both relapse-free and overall survival as key metrics is crucial, as these are the gold standards for assessing efficacy in hematological malignancies.
If the expanded trial confirms the promising results seen so far, it could position INB-100 as a potential game-changer in AML treatment, where new therapeutic options are sorely needed.
- Cash position now expected to fund current operating plan into 2026
- Financing provides cash runway to advance the ongoing expansion cohorts in the Phase 1 trial of INB-100 for patients with Acute Myeloid Leukemia (AML)
NEW YORK, Oct. 01, 2024 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage biopharmaceutical company focused on innovative gamma-delta T cell therapies, today announced that it has entered into a definitive securities purchase agreement with accredited investors for a private placement that is expected to result in gross proceeds of approximately
The private placement was led by an existing healthcare-focused institutional investor and included a large mutual fund company and other existing and new institutional investors.
Under the terms of the securities purchase agreement, the Company will sell units comprised of an aggregate of 25,759,595 shares of the Company’s common stock, par value
IN8bio intends to use the net proceeds from the private placement to fund the clinical development of INB-100 and future product candidates and for working capital and other general corporate purposes. The proceeds will support the continued enrollment of patients in the expansion cohort with a new target total enrollment of approximately 25 patients at the recommended Phase 2 dose. IN8bio expects to complete this additional enrollment in the first half of 2025, with long-term follow-up results anticipated in late 2025 and in 2026. To affirm the improvements in relapse free and overall survival observed to date and to further de-risk a future registrational randomized control trial, IN8bio will also seek to add a parallel control cohort to prospectively assess leukemia patients and enable comparison between patients receiving INB-100 to those who only receive standard haplotransplantation.
The closing of the private placement is subject to customary closing conditions and is expected to occur on or about October 4, 2024.
Newbridge Securities Corporation acted as the sole placement agent for the private placement.
The offer and sale of the foregoing securities is being made in a private placement pursuant to an exemption under the Securities Act of 1933, as amended (the “Securities Act”), and the Securities have not been registered under the Securities Act or applicable state securities laws. The Securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and applicable state securities laws.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy the Securities, nor shall there be any sale of the Securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
About IN8bio
IN8bio is a clinical-stage biopharmaceutical company developing gamma-delta T cell-based immunotherapies for cancer patients. Gamma-delta T cells are a specialized population of T cells that possess unique properties, including the ability to differentiate between healthy and diseased tissue. The company’s lead program, INB-100, is focused on AML evaluating haplo-matched allogenic gamma-delta T cells given to patients following a hematopoietic stem cell transplant. The company is also evaluating autologous DeltEx DRI gamma-delta T cells, in combination with standard of care, for glioblastoma.
Forward Looking Statements
This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding the completion of the offering, the satisfaction of customary closing conditions relating to the private placement, the use of the net proceeds in this private placement, IN8bio’s ability to achieve anticipated milestones, including the completion of enrollment of additional patients and data readouts in the INB-100 trial, IN8bio’s ability to add a parallel control cohort to the INB-100 trial, and IN8bio’s cash runway. IN8bio may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: the uncertainties related to market and other conditions and the completion of the public offering; risks to patient enrollment and follow-up, as well as IN8bio’s ability to meet anticipated deadlines and milestones; and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements. These and other factors are described in greater detail in the section entitled “Risk Factors” in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 8, 2024, as well as in other filings IN8bio may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and IN8bio expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.
Investors and Corporate Contact:
Glenn Schulman, PharmD, MPH
IN8bio, Inc.
203.494.7411
gdschulman@IN8bio.com
Patrick McCall
IN8bio, Inc.
646.933.5603
pfmccall@IN8bio.com
Media Contact:
Kimberly Ha
KKH Advisors
917.291.5744
Kimberly.ha@kkhadvisors.com
FAQ
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