IN8bio Reports First Quarter 2024 Financial Results and Recent Corporate Highlights
IN8bio, Inc. (Nasdaq: INAB) reported financial results for Q1 2024, highlighting progress in gamma-delta T cell programs. Key points include preclinical data on nsCAR platform targeting cancer cells, peer-reviewed publication on DeltEx Drug Resistant Immunotherapy for GBM, and dosing first patient in Phase 2 clinical trial. Financially, R&D expenses increased to $4.9 million, G&A expenses were $3.7 million, net loss was $8.6 million, and cash position stood at $13.0 million.
IN8bio made progress in advancing gamma-delta T cell programs, demonstrating potential of nsCAR platform to target cancer cells effectively while preserving healthy tissue.
Peer-reviewed publication on DeltEx Drug Resistant Immunotherapy for GBM showcases a rational therapeutic approach for newly diagnosed patients.
Progress in Phase 2 clinical trial with first patient dosed shows commitment to developing innovative therapies for patients with GBM.
R&D expenses increased to $4.9 million due to higher personnel-related costs and direct clinical costs for multiple programs, impacting the company's financials.
Net loss of $8.6 million in Q1 2024, compared to $7.5 million in the previous year period, highlights financial challenges faced by the company.
Cash position decreased to $13.0 million by the end of Q1 2024, compared to $21.3 million in the previous quarter, indicating a decline in available funds.
Insights
IN8bio Inc.'s recent financial report indicates a year-over-year increase in R&D and G&A expenses, suggesting a ramp-up in their drug development activities, particularly for their gamma-delta T cell therapies. The increase in personnel costs and clinical trial expenses for INB-100, INB-200 and INB-400 are consistent with a company in a growth phase within the biopharmaceutical industry, aiming to bring new treatments to market.
However, this growth also comes with a widened net loss, growing from
On the positive side, the ongoing clinical trials and the progression towards a Phase 2 trial submission may serve as potential catalysts for the stock if results are favorable. Yet, investors must weigh the costs of clinical development against the likelihood of successful market entry and future revenue streams.
The reported advancements in IN8bio's nsCAR platform and the dosing of the first patient in the INB-400 Phase 2 trial for GBM are noteworthy in terms of the company's pipeline development. The focus on 'undruggable' targets is particularly intriguing as it represents an area of high unmet need within oncology. If successful, this could position the company as a leader in a niche but critical segment of cancer treatment.
However, promising preclinical data does not always translate to clinical success. The true test will be the upcoming readouts from Phase 1 trials for INB-100 and INB-200. Investors should pay close attention to the survival rate data and efficacy signals, as these will be critical determinants of the therapy's future and its commercial potential.
The DeltEx DRI approach for GBM shows a strategic move into combination therapies that may enhance the effectiveness of standard treatments. Yet, GBM is a notoriously difficult indication with many failed attempts at new therapies, so while the innovative approach is promising, the investment risk remains high until further efficacy can be demonstrated in clinical settings.
- Presented new preclinical data demonstrating proof-of-concept for non-signaling Chimeric Antigen Receptor (nsCAR) platform to effectively target cancer cells while preserving healthy tissue
- Demonstrated potential of nsCAR platform to treat previously “undruggable” solid and liquid tumor targets
- Announced peer-reviewed publication in ‘Frontiers in Immunology’ on IN8bio’s DeltEx Drug Resistant Immunotherapy (DRI) approach to newly diagnosed glioblastoma multiforme (GBM)
- Dosed first patient in autologous arm of INB-400 Phase 2 clinical trial for patients with newly diagnosed GBM
NEW YORK, May 09, 2024 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, today reported financial results for the first quarter ended March 31, 2024 and recent corporate highlights.
“We continued to make significant progress advancing our gamma-delta T cell programs in the first quarter of 2024,” said William Ho, CEO and co-founder of IN8bio. “We presented new preclinical data on our nsCAR platform at the American Association for Cancer Research (AACR) 2024 Annual Meeting demonstrating its potential to target and kill various acute myeloid leukemia (AML) cells by targeting CD33 and/or CD123, while preserving healthy bone marrow cells. These findings reinforce our technology’s ability to precisely target “undruggable” cancer targets that have historically been challenging due to on-target, off-tumor toxicity. We will provide an update from our Phase 1 study of INB-100 at the 2024 European Hematology Association (EHA) Annual Meeting in June, including patient status and survival rate data. We anticipate enrolling ten additional patients in an expansion cohort at the recommended Phase 2 dose, and could potentially submit an investigational new drug (IND) application for a Phase 2 randomized control trial this year. In addition, at the American Society of Clinical Oncology (ASCO) Annual Meeting, we will provide an update on our Phase 1 INB-200 study in GBM which generated an initial efficacy signal supporting the INB-400 trial.”
Corporate Highlights and Recent Developments
- Presented data at AACR 2024, supporting the potential of proprietary constructs targeting CD33 and/or CD123 for in vitro evaluation against various types of leukemia, including AML and chronic myeloid leukemia (CML).
- Demonstrated significant differences between cells expressing traditional signaling chimeric antigen receptors (CARs) and those expressing nsCAR constructs, which include a reduction in activation-induced cell death with nsCAR constructs.
- Peer-reviewed publication of “Adoptive Cell Therapy for High Grade Gliomas using Simultaneous Temozolomide and Intracranial MGMT-Modified γδ T cells Following Standard Post-Resection Chemotherapy and Radiotherapy: Current Strategy and Future Directions” in Frontiers in Immunology detailing IN8bio’s DeltEx Drug Resistant Immunotherapy (DRI) as a rational therapeutic approach for newly diagnosed GBM.
- Announced first patient dosed in the Phase 2 autologous arm of INB-400 in patients with newly diagnosed GBM.
Upcoming Anticipated Pipeline Milestones and Events
- American Society of Gene & Cell Therapy (ASGCT) 2024 Annual Meeting (May 10, 2024): Upcoming oral presentation: “Healthy Donor vs Patient Manufactured Autologous DeltEx DRI Product; Immunophenotyping Gene Expression,” will unveil new data highlighting the characterization of our clinical manufactured DeltEx DRI product. The presentation will explore the impact of manufacturing on the final cell product from healthy donors and those manufactured from cancer patients, showcasing IN8bio’s robust capabilities and know-how in complex cell therapy process development and manufacturing.
- INB-100: Report updated interim results from the ongoing Phase 1 investigator-sponsored trial at the 2024 EHA Annual Meeting, held June 13-16 in Madrid, Spain. In addition, we will potentially submit an IND application for a Phase 2 registrational trial in 2024 in the AML and myelodysplastic syndrome (MDS) patient setting.
- INB-200: Report interim Phase 1 long-term follow up results in GBM at multiple medical meetings in 2024 including at the 2024 ASCO Annual Meeting.
- INB-400: Initiated patient dosing in the Phase 2 autologous arm of INB-400 in newly diagnosed GBM. IN8bio expects to treat up to a total of 40 patients in arm A at multiple sites across the United States.
First Quarter 2024 Financial Highlights
- Research and Development (R&D) expenses: R&D expenses were
$4.9 million , compared to$4.4 million for the comparable prior year period. The increase was primarily due to (i) increased personnel-related costs, including salaries and stock-based compensation due to increased headcount and (ii) direct clinical costs for INB-100, INB-200 and INB-400. - General and administrative expenses: General and administrative expenses were
$3.7 million , compared to$3.5 million for the comparable prior year period. The increase was primarily due to increased personnel-related costs, including stock-based compensation and rent, offset by cost savings related to directors’ and officers’ insurance premiums and a reduction in professional services. - Net loss: Net loss was
$8.6 million , or$0.20 per basic and diluted common share, compared to a net loss of$7.5 million , or$0.30 per basic and diluted common share, for the comparable prior year period. - Cash position: As of March 31, 2024, the Company had cash of
$13.0 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 IN8bio’s proprietary nsCAR platform to selectively eliminate cancer cells while preserving healthy tissue; 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 Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 14, 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) | ||||||||
| March 31, | ||||||||
| 2024 | December 31, | |||||||
| (unaudited) | 2023 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash | $ | 13,015 | $ | 21,282 | ||||
| Prepaid expenses and other current assets | 2,740 | 3,343 | ||||||
| Total Current Assets | 15,755 | 24,625 | ||||||
| Non-current assets | ||||||||
| Property and equipment, net | 3,325 | 3,514 | ||||||
| Construction in progress | 203 | 182 | ||||||
| Restricted cash | 256 | 256 | ||||||
| Right-of-use assets - finance leases | 1,160 | 1,364 | ||||||
| Right-of-use assets - operating leases | 4,530 | 3,513 | ||||||
| Other non-current assets | 320 | 255 | ||||||
| Total Non-Current Assets | 9,794 | 9,084 | ||||||
| Total Assets | $ | 25,549 | $ | 33,709 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Liabilities | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 1,413 | $ | 924 | ||||
| Accrued expenses and other current liabilities | 895 | 2,955 | ||||||
| Short-term finance lease liability | 680 | 694 | ||||||
| Short-term operating lease liability | 856 | 820 | ||||||
| Total Current Liabilities | 3,844 | 5,393 | ||||||
| Long-term finance lease liability | 351 | 525 | ||||||
| Long-term operating lease liability | 3,828 | 2,854 | ||||||
| Total Non-Current Liabilities | 4,179 | 3,379 | ||||||
| Total Liabilities | 8,023 | 8,772 | ||||||
| Stockholders' Equity | ||||||||
| Preferred stock, par value | — | — | ||||||
| Common stock, par value | 4 | 4 | ||||||
| Additional paid-in capital | 117,303 | 116,152 | ||||||
| Accumulated deficit | (99,781 | ) | (91,219 | ) | ||||
| Total Stockholders' Equity | 17,526 | 24,937 | ||||||
| Total Liabilities and Stockholders' Equity | $ | 25,549 | $ | 33,709 | ||||
| IN8BIO, INC. CONDENSED STATEMENTS OF OPERATIONS (In thousands, except share and per share data) (Unaudited) | |||||||
| Three Months Ended March 31, | |||||||
| 2024 | 2023 | ||||||
| Operating expenses: | |||||||
| Research and development | $ | 4,903 | $ | 4,385 | |||
| General and administrative | 3,742 | 3,470 | |||||
| Total operating expenses | 8,645 | 7,855 | |||||
| Interest income | 83 | — | |||||
| Other income | — | 330 | |||||
| Loss from operations | (8,562 | ) | (7,525 | ) | |||
| Net loss | $ | (8,562 | ) | $ | (7,525 | ) | |
| Net loss per share – basic and diluted | $ | (0.20 | ) | $ | (0.30 | ) | |
| Weighted-average number of shares used in computing net loss per common share, basic and diluted | 43,287,325 | 24,732,580 | |||||
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
FAQ
What did IN8bio report in the first quarter of 2024?
IN8bio reported financial results for Q1 2024, showcasing progress in gamma-delta T cell programs and recent corporate highlights.
What is the stock symbol for IN8bio?
The stock symbol for IN8bio is INAB.
What key publications were announced by IN8bio?
IN8bio announced a peer-reviewed publication in 'Frontiers in Immunology' on DeltEx Drug Resistant Immunotherapy for newly diagnosed GBM.
What was the financial status of IN8bio in Q1 2024?
IN8bio reported R&D expenses of $4.9 million, G&A expenses of $3.7 million, net loss of $8.6 million, and a cash position of $13.0 million in Q1 2024.
