UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results of Operations and Financial Condition.
On August 10, 2023, IN8bio, Inc. issued a press release announcing its financial results for the quarter ended June 30, 2023. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information in this Form 8-K, including Exhibit 99.1 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
d) Exhibits.
Exhibit No. |
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Description |
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99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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IN8bio, Inc. |
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Date: |
August 10, 2023 |
By: |
/s/ Patrick McCall |
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Patrick McCall |
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Chief Financial Officer and Secretary (Principal Financial and Accounting Officer) |
Exhibit 99.1
IN8bio Reports Second Quarter 2023 Financial Results and Provides Corporate Update
NEW YORK, August 10, 2023 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, today announced financial results and operational highlights for the second quarter ended June 30, 2023. In addition, the Company provided an overview of recent corporate developments through August 2023.
“We made significant clinical advancements in our gamma-delta T cell programs in the second quarter of 2023, sharing encouraging positive data from our INB-100 and INB-200 programs at major medical meetings as well as increasing enrollment across our clinical pipeline,” said William Ho, CEO and co-founder of IN8bio. “We were honored to be selected as one of only four oral presentations and the only Phase 1 program for central nervous system tumors at the ASCO 2023 Annual Meeting. The positive clinical data from both of our Phase 1 trials continues to demonstrate the potential of gamma-delta T cell therapy in preventing relapse and ultimately prolonging survival in patients with these devastating diseases. Our clinical programs investigate the safety, durability and potential utility of gamma-delta T cells as a much-needed treatment option for
cancer patients. We look forward to providing additional updates at medical meetings this fall.”
Business Highlights and Recent Developments
Second Quarter 2023 Financial Highlights
About IN8bio
IN8bio is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of gamma-delta T cell product candidates for solid and liquid tumors. 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. IN8bio’s DeltEx platform employs allogeneic, autologous, iPSC and genetically modified approaches to develop cell therapies, designed to effectively identify and eradicate tumor cells.
IN8bio is currently conducting two investigator-initiated Phase 1 clinical trials for its lead gamma-delta T cell product candidates: INB-200 for the treatment of newly diagnosed glioblastoma and INB-100 for the treatment of patients with leukemia undergoing hematopoietic stem cell transplantation. Pursuant to a company-sponsored IND cleared by the FDA in late 2022, the Company plans to initiate a Phase 2 clinical trial of INB-400 for the treatment of newly diagnosed GBM in the second half of 2023. IN8bio also has a broad portfolio of preclinical programs focused on addressing other hematological and solid tumor types. For more information about IN8bio and its programs, please 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 the development and continued progress and success of our preclinical and clinical trials and programs; the timing of initiation, progress and scope of clinical trials; the synergistic potential of DeltEx gamma-delta T cells and chemotherapy to target solid tumors beyond the brain; future results in clinical data relating to the INB-100, INB-200 and INB-400 studies; the synergistic potential of combining gamma-delta T cells and chemotherapy to recognize and eradicate cancer cells across a broad range of challenging cancer indications beyond the brain and its use as novel therapy for ovarian cancer; the timing, initiation, and readout of clinical data from IN8bio’s clinical trials, including expectations regarding enrollment and the timing of data therefrom; the ability of IN8bio’s new R&D facility in Birmingham, AL to play a vital role in enhancing the Company’s preclinical R&D and process development capabilities; and IN8bio’s ability to achieve anticipated milestones, including expected data readouts from its trials, enrollment of additional patients in its clinical trials, advancement of clinical development plans and to develop new preclinical
programs. 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; 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. 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 May 12, 2023, 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.
BALANCE SHEETS
(In thousands, except share and per share data)
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June 30, |
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2023 |
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December 31, |
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(unaudited) |
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2022 |
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Assets |
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Current assets |
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Cash |
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$ |
16,993 |
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$ |
18,182 |
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Prepaid expenses and other current assets |
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2,472 |
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4,052 |
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Total Current Assets |
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19,465 |
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22,234 |
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Non-current assets |
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Property and equipment, net |
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3,977 |
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4,397 |
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Construction in progress |
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93 |
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29 |
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Restricted cash |
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253 |
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252 |
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Right-of-use assets - finance leases |
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1,817 |
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1,691 |
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Right-of-use assets - operating leases |
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3,858 |
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4,181 |
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Other non-current assets |
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255 |
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255 |
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Total Non-Current Assets |
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10,253 |
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10,805 |
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Total Assets |
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$ |
29,718 |
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$ |
33,039 |
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Liabilities and Stockholders' Equity |
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Liabilities |
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Current liabilities |
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Accounts payable |
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$ |
585 |
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$ |
2,091 |
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Accrued expenses and other current liabilities |
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1,674 |
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2,342 |
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Short-term finance lease liability |
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765 |
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682 |
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Short-term operating lease liability |
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757 |
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707 |
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Total Current Liabilities |
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3,781 |
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5,822 |
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Long-term finance lease liability |
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861 |
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811 |
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Long-term operating lease liability |
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3,277 |
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3,674 |
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Total Non-Current Liabilities |
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4,138 |
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4,485 |
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Total Liabilities |
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7,919 |
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10,307 |
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Stockholders' Equity |
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Preferred stock, par value $0.0001 per share; 10,000,000 shares authorized at June 30, 2023 and December 31, 2022, respectively. No shares issued and outstanding |
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— |
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Common stock, par value $0.0001 per share; 490,000,000 shares authorized at June 30, 2023 and December 31, 2022; 30,606,119 and 24,545,157 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively |
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4 |
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3 |
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Additional paid-in capital |
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98,247 |
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83,941 |
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Accumulated deficit |
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(76,452 |
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(61,212 |
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Total Stockholders' Equity |
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21,799 |
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22,732 |
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Total Liabilities and Stockholders' Equity |
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$ |
29,718 |
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$ |
33,039 |
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IN8BIO, INC.
STATEMENTS OF OPERATIONS
(In thousands, except share and per share data)
(Unaudited)
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Three Months Ended |
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Six Months Ended |
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2023 |
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2022 |
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2023 |
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2022 |
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Operating expenses: |
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Research and development |
$ |
4,134 |
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$ |
3,504 |
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$ |
8,519 |
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$ |
5,885 |
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General and administrative |
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3,581 |
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3,675 |
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7,051 |
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7,439 |
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Total operating expenses |
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7,715 |
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7,179 |
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15,570 |
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13,324 |
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Other income |
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— |
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— |
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330 |
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Loss from operations |
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(7,715 |
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(7,179 |
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(15,240 |
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(13,324 |
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Net loss |
$ |
(7,715 |
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$ |
(7,179 |
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$ |
(15,240 |
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$ |
(13,324 |
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Net loss per share – basic and diluted |
$ |
(0.27 |
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$ |
(0.38 |
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$ |
(0.57 |
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$ |
(0.71 |
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Weighted-average number of shares used in computing net loss per common share, basic and diluted |
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28,472,346 |
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18,828,680 |
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26,612,794 |
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18,814,691 |
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Company Contact:
IN8bio, Inc.
Patrick McCall
+ 1 646.600.6GDT (6438)
info@IN8bio.com
Investors & Media Contact:
Argot Partners
IN8bio@argotpartners.com