IN8bio(INAB)
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IN8bio to Present at International Society for Cell & Gene Therapy (ISCT) 2024
globenewswire.com· 2024-05-24 12:00
Details of the poster presentations are provided below, and reprints will be accessible following the sessions on the IN8bio website at https://investors.in8bio.com/news-events/events-presentations. INB-400 DeltEx drug resistant immunotherapy (DRI) multi-center clinical trial product logistics management Poster: #816 Session: Poster Networking Reception #1 Date/Time: May 29th, at 7pm-8:30pm PDT Presenter: Guoling Chen, Senior Director Quality Operations, IN8bio Healthy donor vs. Patient manufactured autolog ...
IN8bio Announces INB-200 Phase 1 Study Data in Newly Diagnosed Glioblastoma to be Presented at the 2024 ASCO Annual Meeting
globenewswire.com· 2024-05-23 21:00
NEW YORK, May 23, 2024 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB) a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, today announced an upcoming presentation of updated results from its fully enrolled Phase 1 study of INB-200 at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, to be held May 31st - June 4th in Chicago, Illinois. INB-200 is evaluating autologous Drug Resistant Immunotherapy (DeltEx DRI) or chemotherapy resistant gamma-delt ...
IN8bio(INAB) - 2024 Q1 - Quarterly Report
2024-05-09 20:06
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number: 001-39692 IN8BIO, INC. (Exact name of Registrant as specified in its Charter) Delaware 82-5462585 (State or other jurisdiction of i ...
IN8bio(INAB) - 2024 Q1 - Quarterly Results
2024-05-09 20:04
302406282 v3 IN8bio Reports First Quarter 2024 Financial Results and Recent Corporate Highlights - 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 ...
IN8bio Doses First Patient in Phase 2 Clinical Trial of INB-400 in Newly Diagnosed Glioblastoma
Newsfilter· 2024-04-30 10:05
NEW YORK, April 30, 2024 (GLOBE NEWSWIRE) -- IN8bio, Inc. (NASDAQ:INAB), a clinical-stage biopharmaceutical company advancing innovative gamma-delta T cell therapies, announced today that the first patient in its Phase 2 clinical trial evaluating INB-400 in patients with newly diagnosed glioblastoma multiforme (GBM) has been successfully dosed at the Cleveland Clinic in Ohio. INB-400 is the Company's first autologous gamma-delta T cell therapy product candidate genetically engineered to survive chemotherapy ...
IN8bio Announces New Preclinical Data for Gamma-Delta nsCAR-T Cell Therapy Platform at AACR 2024
Newsfilter· 2024-04-09 20:30
- Preclinical data supports potential for proprietary nsCAR platform to selectively eliminate cancer cells while preserving healthy tissue - Gamma-delta nsCAR platform emerging as an advanced technology for targeting hematologic and solid tumor cancers NEW YORK, April 09, 2024 (GLOBE NEWSWIRE) -- IN8bio, Inc. (NASDAQ:INAB) a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, today announced new preclinical data from its non-signaling gamma-delta T cell based Chime ...
IN8bio(INAB) - 2023 Q4 - Annual Report
2024-03-14 20:11
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO (State or other jurisdiction of incorporation or organization) 350 5th Avenue, Suite 5330 New York, New York 10118 (Address of principal executive offices) (Zip ...
IN8bio(INAB) - 2023 Q4 - Annual Results
2024-03-14 20:09
Financial Performance - IN8bio reported a net loss of $30.0 million, or $1.00 per basic and diluted common share, for the year ended December 31, 2023, compared to a net loss of $28.5 million, or $1.36 per basic and diluted common share, for the prior year[14]. - The total operating expenses for the year ended December 31, 2023, were $30.3 million, compared to $28.5 million in the prior year[14]. - As of December 31, 2023, IN8bio had cash of $21.3 million, an increase from $18.2 million as of December 31, 2022[6]. Research and Development - Research and Development (R&D) expenses increased to $16.8 million for the year ended December 31, 2023, from $14.1 million in the prior year, primarily due to increased personnel-related costs and clinical trial activities[6]. - IN8bio plans to submit an investigational new drug (IND) application for a Phase 3 randomized control trial in 2024 for INB-100[5]. - INB-200 demonstrated that all patients treated exceeded a median progression-free survival (PFS) of seven months, surpassing the standard-of-care median PFS of four to seven months[5]. - The company achieved 100% remission in evaluable patients (n=10) treated with INB-100 in leukemia, with all patients remaining alive and progression-free past 12 months[3]. Administrative Expenses - General and Administrative (G&A) expenses decreased to $13.5 million for the year ended December 31, 2023, from $14.5 million in the prior year, attributed to cost savings in D&O insurance premiums and professional services[6]. Capital and Funding - IN8bio secured initial gross proceeds of $14.4 million from a private placement in December 2023, extending its cash runway into Q1 2025, with potential for up to $32.5 million in additional capital[3]. Leadership Changes - The company appointed Dr. Corinne Epperly to the Board of Directors, enhancing its leadership in immuno-oncology and cell therapy[3].
IN8bio(INAB) - 2023 Q3 - Quarterly Report
2023-11-09 21:06
Company Overview - Company is focused on developing gamma-delta T cell therapies for solid and liquid tumors, leveraging its DeltEx platform for advanced cancer treatment [75]. - The company has received orphan drug designation for INB-400 from the FDA, covering a range of malignant glioma indications [76]. - Preclinical data for INB-300 shows promise in targeting various solid and liquid tumors, with updates expected in 2024 [79]. - The DeltEx platform has produced hundreds of millions of iPSC-derived gamma-delta T cells, demonstrating robust cytotoxic activity against multiple cancer types [80]. - The company plans to file several IND applications for pipeline candidates over the next few years, focusing on expanding treatment indications [81]. Clinical Trials - Enrollment has begun for the Phase 2 trial of INB-400 targeting newly diagnosed glioblastoma (GBM), aiming to enroll approximately 40 patients [76]. - The Phase 1 trial of INB-100 for high-risk leukemias has completed primary enrollment, with clinical data to be presented at the ASH Annual Meeting on December 11, 2023 [78]. - INB-200 trial results suggest potential for sustained immune responses, with updated data to be presented at the SNO Annual Meeting on November 17, 2023 [87]. Financial Performance - Company has $12.9 million in cash as of September 30, 2023, which is projected to be insufficient to cover operating expenses beyond May 2024 [83]. - No revenue has been generated since inception in 2016, and future revenue is contingent on successful product development and regulatory approval [89]. - For the nine months ended September 30, 2023, total operating expenses were $22.7 million, an increase of $2.0 million from $20.7 million in the same period of 2022 [100]. - Research and development expenses for the nine months ended September 30, 2023, totaled $12.3 million, up $2.2 million from $10.1 million in the prior year, driven by a $2.0 million increase in personnel-related costs [103]. - The company raised $101.3 million in gross proceeds from the sale of securities since inception, primarily through equity offerings [106]. - The company sold 7,430,772 shares under its ATM program for net proceeds of $14.3 million during the nine months ended September 30, 2023 [108]. - Other income for the nine months ended September 30, 2023, was $0.3 million, attributed to a contractual arrangement for the transfer of clinical scale gamma-delta T cells [105]. - Net cash used in operating activities was $18.5 million for the nine months ended September 30, 2023, primarily due to a net loss of $22.4 million [123]. - Cash provided by financing activities was $13.7 million during the nine months ended September 30, 2023, mainly from the issuance and sale of common stock [128]. - Cash used in investing activities was $0.5 million for the nine months ended September 30, 2023, primarily for property and equipment purchases [126]. - The company incurred net losses and negative cash flows from operations, with a net decrease in cash and restricted cash of $5.3 million for the nine months ended September 30, 2023 [122]. - The company expects to continue financing operations through additional equity or debt financings, which may result in dilution to existing stockholders [118]. Expenses - Research and development expenses for Q3 2023 were $3.8 million, a decrease of $0.5 million from $4.3 million in Q3 2022, primarily due to a $0.9 million decrease in direct clinical costs [98]. - General and administrative expenses for Q3 2023 were $3.4 million, an increase of $0.3 million from $3.1 million in Q3 2022, mainly due to higher professional services costs [99]. - The company expects research and development expenses to continue increasing as it advances clinical development and discovers new product candidates [92]. - Research and development expenses include salaries, stock-based compensation, lab supplies, and fees paid to third parties [132]. Future Outlook - The company is exploring additional capital raising options and strategic collaborations to support ongoing research and development activities [110]. - The company may seek third-party collaborators for future commercialization of product candidates that receive marketing approval [117]. - The company is classified as a smaller reporting company and is not required to provide detailed market risk disclosures [142]. - As of September 30, 2023, the company had fixed lease payment obligations of $6.5 million, with $2.0 million payable within 12 months [120]. - The company has no long-term debt and no material non-cancelable purchase commitments with service providers [121].
IN8bio(INAB) - 2023 Q2 - Quarterly Report
2023-08-10 21:30
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of "large accelerated filer," "accelerated filer," "smaller reporting company," and ...