IN8bio Reports Second Quarter 2024 Financial Results and Recent Corporate Highlights
IN8bio (NASDAQ: INAB) reported Q2 2024 financial results and corporate highlights. Key points include:
1. Presented 100% 1-year complete remission in evaluable patients with hematologic malignancies for INB-100 at EHA 2024.
2. Demonstrated 92% of glioblastoma patients treated with INB-200 exceeded median seven-month progression-free survival at ASCO 2024.
3. Showcased robust manufacturing platform for DeltEx gamma-delta T cells at ASGCT 2024.
4. Q2 2024 financials: R&D expenses increased to $5.2 million, net loss was $8.6 million ($0.19 per share), and cash position as of June 30, 2024, was $10.2 million.
IN8bio continues to advance its gamma-delta T cell therapies for solid and hematologic cancers, showing promising results in clinical trials.
IN8bio (NASDAQ: INAB) ha riportato i risultati finanziari del Q2 2024 e i principali risultati aziendali. I punti chiave includono:
1. Presentato un tasso di remissione completa del 100% a 1 anno nei pazienti valutabili con neoplasie ematologiche per INB-100 all'EHA 2024.
2. Dimostrato che il 92% dei pazienti con glioblastoma trattati con INB-200 ha superato la mediana di sette mesi di sopravvivenza libera da progressione all'ASCO 2024.
3. Mostrata una piattaforma di produzione robusta per le cellule T gamma-delta DeltEx all'ASGCT 2024.
4. Risultati finanziari del Q2 2024: le spese per R&S sono aumentate a 5,2 milioni di dollari, la perdita netta è stata di 8,6 milioni di dollari (0,19 dollari per azione) e la posizione di liquidità al 30 giugno 2024 era di 10,2 milioni di dollari.
IN8bio continua a sviluppare le sue terapie con cellule T gamma-delta per tumori solidi ed ematologici, mostrando risultati promettenti negli studi clinici.
IN8bio (NASDAQ: INAB) informó sobre los resultados financieros del segundo trimestre de 2024 y los aspectos destacados corporativos. Los puntos clave incluyen:
1. Presentó una remisión completa del 100% a 1 año en pacientes evaluables con malignidades hematológicas para INB-100 en EHA 2024.
2. Demostró que el 92% de los pacientes con glioblastoma tratados con INB-200 superaron la mediana de siete meses de supervivencia libre de progresión en ASCO 2024.
3. Mostró una plataforma de fabricación robusta para células T gamma-delta DeltEx en ASGCT 2024.
4. Resultados financieros del Q2 2024: los gastos de I+D aumentaron a $5.2 millones, la pérdida neta fue de $8.6 millones ($0.19 por acción) y la posición de efectivo al 30 de junio de 2024 era de $10.2 millones.
IN8bio sigue avanzando en sus terapias con células T gamma-delta para cánceres sólidos y hematológicos, mostrando resultados prometedores en ensayos clínicos.
IN8bio (NASDAQ: INAB)는 2024년 2분기 재무 결과 및 기업 하이라이트를 발표했습니다. 주요 사항은 다음과 같습니다:
1. EHA 2024에서 INB-100에 대한 혈액종양 평가 환자에서 1년 완전 관해 100%을 발표했습니다.
2. ASCO 2024에서 INB-200으로 치료받은 92%의 교모세포종 환자가 7개월의 중위 수명 이상의 진행 없는 생존을 초과했습니다.
3. ASGCT 2024에서 DeltEx 감마-델타 T 세포에 대한 강력한 제조 플랫폼을 선보였습니다.
4. 2024년 2분기 재무: 연구개발 비용은 520만 달러로 증가하였고, 순손실은 860만 달러(주당 0.19달러)였으며, 2024년 6월 30일 현재 현금 보유는 1020만 달러였습니다.
IN8bio는 고형 및 혈액암에 대한 감마-델타 T 세포 요법을 발전시키고 있으며, 임상 시험에서 유망한 결과를 보이고 있습니다.
IN8bio (NASDAQ: INAB) a annoncé les résultats financiers du 2ème trimestre 2024 et les moments forts de l'entreprise. Les points clés incluent :
1. Présentation d'une remission complète de 100% sur 1 an chez des patients évaluables ayant des malignités hématologiques pour INB-100 lors de l'EHA 2024.
2. Démonstration que 92% des patients atteints de glioblastome traités avec INB-200 ont dépassé la médiane de sept mois de survie sans progression à l'ASCO 2024.
3. Mise en avant d'une plateforme de fabrication robuste pour les cellules T gamma-delta DeltEx à l'ASGCT 2024.
4. Résultats financiers du 2ème trimestre 2024 : les dépenses en R&D ont augmenté à 5,2 millions de dollars, la perte nette était de 8,6 millions de dollars (0,19 dollar par action) et la position de liquidité au 30 juin 2024 était de 10,2 millions de dollars.
IN8bio continue de faire progresser ses thérapies par cellules T gamma-delta pour les cancers solides et hématologiques, montrant des résultats prometteurs dans les essais cliniques.
IN8bio (NASDAQ: INAB) hat die finanziellen Ergebnisse und Unternehmenshighlights des 2. Quartals 2024 bekannt gegeben. Die wichtigsten Punkte sind:
1. Präsentation einer 100%igen Vollremission nach 1 Jahr bei bewertbaren Patienten mit hämatologischen Malignitäten für INB-100 auf der EHA 2024.
2. Nachgewiesen, dass 92% der Patienten mit Glioblastom, die mit INB-200 behandelt wurden, die mediane siebener Lebensmonate ohne Progression im ASCO 2024 überschritten haben.
3. Robuste Herstellungsplattform für DeltEx Gamma-Delta-T-Zellen auf der ASGCT 2024 präsentiert.
4. Finanzdaten des 2. Quartals 2024: Die F&E-Ausgaben stiegen auf 5,2 Millionen Dollar, der Nettoverlust betrug 8,6 Millionen Dollar (0,19 Dollar pro Aktie) und die Bargeldposition zum 30. Juni 2024 betrug 10,2 Millionen Dollar.
IN8bio setzt seine Entwicklung von Gamma-Delta-T-Zelltherapien für solide und hämatologische Krebserkrankungen fort und zeigt vielversprechende Ergebnisse in klinischen Studien.
- 100% of treated leukemia patients (n=10/10) in Phase 1 trial of INB-100 remained progression-free for at least one year
- 92% of evaluable patients treated with INB-200 exceeded median seven-month progression-free survival in glioblastoma
- Strong safety profile across all three dose cohorts with no cell therapy-related toxicities reported
- Demonstrated long-term in vivo expansion and persistence of gamma-delta T cells for up to 365 days
- Net loss increased to $8.6 million in Q2 2024 compared to $7.7 million in the prior year period
- Cash position decreased to $10.2 million as of June 30, 2024, from $21.3 million on December 31, 2023
- R&D expenses increased to $5.2 million from $4.1 million in the comparable prior year period
Insights
IN8bio's Q2 2024 results reveal a mixed financial picture. While R&D expenses increased by
IN8bio's gamma-delta T cell therapies show promising clinical results. The INB-100 Phase 1 trial demonstrated
IN8bio's DeltEx platform demonstrates robust and reproducible manufacturing of gamma-delta T cells, a critical factor for clinical and commercial success in cell therapies. The platform's ability to generate products with enhanced potency, effector functions and trafficking capabilities across different donor populations is a significant technological advancement. The strong safety profile, with no reported cases of neurotoxicity or cytokine release syndrome, is particularly noteworthy. However, investors should note that while these early-stage results are promising, the path to commercialization remains long and uncertain, with larger trials needed to confirm efficacy and safety.
- Presented positive Phase 1 data showing
- Continues to be an industry leader in the manufacturing and the clinical advancement of gamma-delta T cells for the treatment of solid and hematologic cancers
- Demonstrated robust and reproducible manufacturing platform for DeltEx gamma-delta T cells highlighted during oral presentation at the American Society of Gene & Cell Therapy (ASGCT) 2024 Annual Meeting
- Presented positive data with
NEW YORK, Aug. 08, 2024 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies for solid and hematologic cancers, today reported financial results for the second quarter ended June 30, 2024 and recent corporate highlights.
“Gamma-delta T cell therapies have the potential to revolutionize cancer treatment,” said William Ho, CEO and co-founder of IN8bio. “In the second quarter of 2024, our team presented industry-leading data demonstrating that our gamma-delta T cell therapeutic approach in INB-100 and INB-200 can drive durable complete remissions compared to the current standard-of-care in certain aggressive cancers like GBM and AML, where patients have typically faced poor outcomes. This novel approach that leverages gamma-delta T cells seeks to target residual tumors, including chemo-resistant and cancerous stem cells that often result in relapse. We look forward to providing additional updates on our gamma-delta T cell programs as we generate longer patient follow-up and advance our pipeline.”
Corporate Highlights and Recent Developments
- Presented data at EHA 2024, showing
100% of treated patients with leukemia (n=10/10) in the Phase 1 trial of INB-100 remained progression-free for at least one year, including high-risk and relapsed AML and one with acute lymphocytic leukemia (ALL) who had previously failed multiple lines of therapy, including CAR-T.- Data continue to show long-term in vivo expansion and persistence of haplo-matched allogeneic gamma-delta T cells 365 days following a single administration post-transplant, demonstrating the first-ever durable persistence and in vivo expansion of an allogeneic cellular therapy.
- As of May 31, 2024, two of the patients treated with INB-100 remain alive and relapse free for over three and a half years, and a third patient is nearing three years.
- Poster presentation at ASCO 2024 demonstrated that
92% of evaluable patients treated with INB-200 exceeded a median PFS of seven months with concomitant temozolomide (TMZ), as of a data cutoff date of May 30, 2024.- The survival data along with radiographic improvements are indicative of positive treatment effects, which highlight the potential of IN8bio’s genetically modified, chemotherapy-resistant gamma-delta T cells as a potential first-in-class therapy for patients with newly diagnosed GBM to extend PFS.
- The safety profile of gamma-delta T cells continues to be strong across all three dose cohorts with no cell therapy-related toxicities such as immune effector cell-associated neurotoxicity syndrome or cytokine release syndrome reported in any patients across both Phase 1 trials to date (up to the maximum dose of six infusions of therapy).
- Multiple presentations at the International Society for Cell & Gene Therapy (ISCT) 2024 demonstrated how IN8bio’s manufacturing process influences product characteristics and the ability to generate a robust, activated and reproducible final product.
- DeltEx gamma-delta T cell manufacturing platform has enabled the development of multiple investigational candidates which are now moving into multi-center Phase 2 clinical trials and are designed to target and potentially eradicate cancer cells to help improve patient outcomes.
- The cellular characteristics of products from the company’s proprietary clinical-scale gamma-delta T cell manufacturing platform were shown across different donor populations at the ASGCT 2024 Annual Meeting.
- Data demonstrated that the manufacturing process results in investigational products with upregulated markers of potency, effector functions and trafficking capabilities, which IN8bio believes represents a significant advancement in the characterization of gamma-delta T cell-based therapies.
Second Quarter 2024 Financial Highlights
- Research and Development (R&D) expenses: R&D expenses were
$5.2 million , compared to$4.1 million for the comparable prior year period. The increase was primarily due to a$0.5 million increase in personnel-related costs, including salaries and non-cash stock-based compensation due to increased headcount. Direct clinical costs increased by$0.5 million due to increased enrollment costs for our clinical programs, partially offset by a decrease of$0.1 million in facilities costs. - General and administrative expenses: General and administrative expenses remained flat at
$3.5 million , compared to$3.6 million for the comparable prior year period. - Net loss: Net loss was
$8.6 million , or$0.19 per basic and diluted common share, compared to a net loss of$7.7 million , or$0.27 per basic and diluted common share, for the comparable prior year period. - Cash position: As of June 30, 2024, the Company had cash of
$10.2 million , compared to$21.3 million , as of December 31, 2023.
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-400 is in a Phase 2 trial in glioblastoma multiforme (GBM). Additional programs include Phase 1 trials in solid and hematologic tumors, including INB-200 for GBM and INB-100 for patients with hematologic malignancies undergoing transplantation. For more information about IN8bio, visit www.IN8bio.com.
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: IN8bio’s ability to continue advancing our gamma-delta T-cell programs; the potential of gamma-delta T cell therapies to revolutionize cancer treatment; the ability of INB-100 and INB-200 to target difficult to treat cancers, including chemo-resistant and cancerous stem cells; the continued ability of IN8bio’s manufacturing process to influence product characteristics and generate a robust, [activated,] reproducible final product; and IN8bio’s ability to achieve anticipated milestones, including expected presentations and data readouts from its trials, enrollment of additional patients in its clinical trials, advancement of clinical development plans and submission of INDs. 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: risks to site initiation, clinical trial commencement, patient enrollment and follow-up, as well as IN8bio’s ability to meet anticipated deadlines and milestones, presented by public health crises as well as rising inflation and regulatory developments; uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of IN8bio’s product candidates; the risk that IN8bio may not realize the intended benefits of its DeltEx platform; availability and timing of results from preclinical studies and clinical trials; whether the outcomes of preclinical studies will be predictive of clinical trial results; whether initial or interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; the risk that trials and studies may be delayed and may not have satisfactory outcomes; potential adverse effects arising from the testing or use of IN8bio’s product candidates; expectations for regulatory approvals to conduct trials or to market products; IN8bio’s reliance on third parties, including licensors and clinical research organizations; and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, 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.
| IN8BIO, INC. CONDENSED BALANCE SHEETS (In thousands, except share and per share data) | ||||||||
| June 30, | ||||||||
| 2024 | December 31, | |||||||
| (unaudited) | 2023 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash | $ | 10,217 | $ | 21,282 | ||||
| Prepaid expenses and other current assets | 2,465 | 3,343 | ||||||
| Total Current Assets | 12,682 | 24,625 | ||||||
| Non-current assets | ||||||||
| Property and equipment, net | 3,112 | 3,514 | ||||||
| Construction in progress | 265 | 182 | ||||||
| Restricted cash | 259 | 256 | ||||||
| Right-of-use assets - finance leases | 1,531 | 1,364 | ||||||
| Right-of-use assets - operating leases | 4,327 | 3,513 | ||||||
| Other non-current assets | 320 | 255 | ||||||
| Total Non-Current Assets | 9,814 | 9,084 | ||||||
| Total Assets | $ | 22,496 | $ | 33,709 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Liabilities | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 1,444 | $ | 924 | ||||
| Accrued expenses and other current liabilities | 1,533 | 2,955 | ||||||
| Short-term finance lease liability | 895 | 694 | ||||||
| Short-term operating lease liability | 887 | 820 | ||||||
| Total Current Liabilities | 4,759 | 5,393 | ||||||
| Long-term finance lease liability | 526 | 525 | ||||||
| Long-term operating lease liability | 3,590 | 2,854 | ||||||
| Total Non-Current Liabilities | 4,116 | 3,379 | ||||||
| Total Liabilities | 8,875 | 8,772 | ||||||
| Stockholders' Equity | ||||||||
| Preferred stock, par value | — | — | ||||||
| Common stock, par value | 5 | 4 | ||||||
| Additional paid-in capital | 122,026 | 116,152 | ||||||
| Accumulated deficit | (108,410 | ) | (91,219 | ) | ||||
| Total Stockholders' Equity | 13,621 | 24,937 | ||||||
| Total Liabilities and Stockholders' Equity | $ | 22,496 | $ | 33,709 | ||||
| IN8BIO, INC. CONDENSED STATEMENTS OF OPERATIONS (In thousands, except share and per share data) (Unaudited) | |||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | $ | 5,156 | $ | 4,134 | $ | 10,059 | $ | 8,519 | |||||||
| General and administrative | 3,533 | 3,581 | 7,275 | 7,051 | |||||||||||
| Total operating expenses | 8,689 | 7,715 | 17,334 | 15,570 | |||||||||||
| Interest income | 60 | — | 143 | — | |||||||||||
| Other income | — | — | — | 330 | |||||||||||
| Loss from operations | (8,629 | ) | (7,715 | ) | (17,191 | ) | (15,240 | ) | |||||||
| Net loss | $ | (8,629 | ) | $ | (7,715 | ) | $ | (17,191 | ) | $ | (15,240 | ) | |||
| Net loss per share – basic and diluted | $ | (0.19 | ) | $ | (0.27 | ) | $ | (0.39 | ) | $ | (0.57 | ) | |||
| Weighted-average number of shares used in computing net loss per common share, basic and diluted | 45,126,064 | 28,472,346 | 44,493,815 | 26,612,794 | |||||||||||
Corporate Contact:
IN8bio, Inc.
Glenn Schulman, PharmD, MPH
203.494.7411
gdschulman@IN8bio.com
Investors
Meru Advisors
Lee M. Stern
lstern@meruadvisors.com
Media Contact
Kimberly Ha
KKH Advisors
917.291.5744
kimberly.ha@kkhadvisors.com
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