On September 10, 2021 IN8bio, Inc., a clinical-stage biopharmaceutical company focused on the discovery and development of innovative gamma-delta T-cell therapies utilizing its DeltEx platform, reported financial results and operational highlights for the second quarter ended June 30, 2021 (Filing, 3 mnth, JUN 30, In8bio, 2021, SEP 10, 2021, View Source [SID1234587529]). In addition, the Company provided an overview of recent corporate developments.
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"In the second quarter and subsequent months, we have demonstrated progress in both of our clinical programs," said William Ho, Chief Executive Officer and co-founder of IN8bio. "We successfully completed treatment of the first cohort in the INB-200 Phase 1 trial using our genetically modified gamma-delta T cell candidate in development for treating solid tumors. We also completed dosing of the first cohort of the Phase 1 trial of INB-100, an allogeneic gamma-delta T cell product candidate in development for leukemia patients. We anticipate reporting updates to both programs in the coming months, and given our strengthened cash position from the IPO, we will continue to progress our trials and other pipeline programs."
Successful Initial Public Offering
On August 3, 2021, IN8bio completed its initial public offering, in which it issued and sold 4,000,000 shares of common stock at a public offering price of $10.00 per share. The net proceeds to the Company were approximately $32.6 million, after deducting underwriting discounts, commissions and estimated offering expenses. On September 7, 2021, subsequent to the IPO, there were 18,754,553 shares of common stock outstanding.
Second Quarter Business Highlights & Company Updates
During the second quarter, IN8bio presented data demonstrating in vitro activity of INB-300, our DeltEx drug-resistant immunotherapy (DRI) CAR-T cells against glioblastoma multiforme (GBM) at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021. Gamma-delta T cells were engineered with a chlorotoxin CAR-T binding domain and a chemotherapy resistance gene, which enhances binding to tumor cells and survival of concomitant dosing with alkylating chemotherapies, such as temozolomide, or TMZ.
During the second quarter, IN8bio presented data at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from the first cohort of a Phase 1 clinical trial of INB-200 in patients with newly diagnosed GBM. INB-200 was generally well tolerated with no observed infusion reactions, cytokine release syndrome (CRS), neurotoxicity or dose limiting toxicities (DLTs). Enrollment for the second cohort of this trial was initiated. All three treated patients exceeded their expected median progression-free survival based on their respective age and O-6-Methylguanine-DNA Methyltransferase (MGMT) status. The Company expects to report additional data from this Phase 1 trial by the end of 2021.
In July 2021, IN8bio appointed Emily Fairbairn and Luba Greenwood as two independent members of the Company’s Board of Directors. Ms. Fairbairn is currently a principal of Transcend Partners and was co-founder and CEO of Ascend Capital. Ms. Greenwood serves as Managing Partner of Binney Street Capital LLC, a venture capital fund established by the Dana Farber Cancer Institute.
In August 2021, IN8bio completed dosing of the first cohort of INB-100, a Phase 1 clinical trial of donor-derived allogeneic gamma-delta T cells in leukemia patients undergoing hematopoietic stem cell transplant (HSCT). No severe adverse infusion reactions or DLTs were observed. The first two patients continue in complete remission more than one year after treatment. The Company expects to report initial results from the first cohort in this Phase 1 trial in 2022, with topline results for all cohorts in 2023.
Second Quarter 2021 Financial Highlights
Cash position: As of June 30, 2021, the Company has cash of $12.0 million, compared to $18.0 million as of December 31, 2020. Subsequent to the end of the second quarter, the Company completed its initial public offering that raised net proceeds of $32.6 million after underwriting discounts, commissions and estimated offering expenses of $7.4 million.
Research and development (R&D) expense: Research and development expense was $2.1 million for the three months ended June 30, 2021, compared to $1.8 million for the comparable prior year period. The increase in R&D expense was due primarily to third-party costs associated with our clinical programs for INB-200 and increased personnel costs, including non-cash stock-based compensation.
General and administrative expense: General and administrative expense was $1.0 million for the three months ended June 30, 2021, compared to $1.1 million for the comparable prior year period. The decrease was due primarily to decreased legal and professional fees partially offset by increased personnel costs, including non-cash stock-based compensation.
Net loss: The Company reported a net loss of $3.1 million and a net loss attributable to common stockholders of $3.8 million, or ($1.00) per basic and diluted common share, for the three months ended June 30, 2021, compared to a net loss of $2.9 million and a net loss attributable to common stockholders of $3.2 million, or ($0.92) per basic and diluted common share, for the comparable prior year period.