8-K
false000174027900017402792023-08-102023-08-10

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 10, 2023

 

 

IN8bio, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-39692

82-5462585

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

350 5th Avenue, Suite 5330

 

New York, New York

 

10118

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: 646 600-6438

 

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

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:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common Stock, $0.0001 par value per share

 

INAB

 

The Nasdaq Stock Market LLC

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.

 

Description

 

 

99.1

 

Press Release, dated August 10, 2023.

104

 

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.

IN8bio, Inc.

Date:

August 10, 2023

By:

/s/ Patrick McCall

Patrick McCall

 

Chief Financial Officer and Secretary

(Principal Financial and Accounting Officer)

 


EX-99.1

https://cdn.kscope.io/17ff26911b1f7e071ce4f9499f19d369-img75407775_0.jpg 

Exhibit 99.1

 

IN8bio Reports Second Quarter 2023 Financial Results and Provides Corporate Update

 

Presented positive INB-200 Phase 1 data in an oral presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting showing 100% of treated patients (n=8) have exceeded historical median progression-free survival
INB-400 on track to initiate enrollment in glioblastoma multiforme (GBM) in the second half of 2023. The Phase 2 trial (NCT05664243) will initially enroll newly diagnosed GBM patients in the autologous setting. The primary endpoint of the study is overall survival (OS); secondary endpoints include tolerability, progression-free survival (PFS), overall response rate (ORR) and time to progression (TTP)
Promising preclinical data in ovarian cancer announced at the American Society of Gene & Cell Therapy (ASGCT) Annual Meeting underscores the synergistic potential of DeltEx gamma-delta T cells and chemotherapy to target solid tumors beyond brain cancer
Additional clinical and pipeline updates expected at a research and development (R&D) day on October 12, 2023 in New York City and at fall medical meetings with abstracts submitted for Society for Immunotherapy of Cancer (SITC), Society for Neuro-Oncology (SNO), and the American Society of Hematology (ASH) Annual Meetings in the fourth quarter of 2023

 

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

Presented positive INB-200 Phase 1 data update in GBM showing 100% of treated patients (n=8) to date have exceeded median progression-free survival at the ASCO 2023 Annual Meeting. Results support the potential of DeltEx drug resistant immunotherapy (DRI) to improve progression-free survival and overall survival in patients with newly diagnosed GBM, demonstrating that multiple doses in later cohorts did not lead to any changes in toxicity profile. The Company is on track to complete INB-200 Phase 1 study enrollment in 2023 with updated data expected to be presented later this year.
Presented new promising preclinical data underscoring the potential of DeltEx gamma-delta T cells to target and kill ovarian cancer cells at the ASGCT 26th Annual Meeting. The results showcased the powerful synergistic potential of combining gamma-delta T cells and chemotherapy to enhance their ability to recognize and eradicate cancer cells across a broad range of challenging cancer indications beyond the brain and has the potential to be developed as a novel therapy for ovarian cancer.
Announced upcoming R&D Day in October. The Company will be hosting an R&D Day on Thursday, October 12, 2023 in New York City, with details to follow.
Announced opening of advanced R&D facility in Birmingham. The Company recently announced that it has opened a new R&D facility in Birmingham, AL. Complementing the Company’s current GMP manufacturing spaces, this facility will play a vital role in enhancing the Company's preclinical R&D and process development capabilities. These facilities will be instrumental in advancing our groundbreaking pipeline of gamma-delta T cell therapies, setting the stage for future clinical and pipeline developments.

 

Second Quarter 2023 Financial Highlights

Research and Development (R&D) expenses: R&D expenses were $4.1 million for the three months ended June 30, 2023, compared to $3.5 million for the comparable prior year period. The increase in R&D expenses was primarily due to (i) contract research organization expenses related to the initiation of INB-400, (ii) completion of additional lentiviral vector manufacturing to support the INB-400 program and (iii) increased personnel-related costs, including salaries, benefits, and stock-based compensation due to increased headcount.
General and administrative (G&A) expenses: G&A expenses were $3.6 million for the three months ended June 30, 2023, compared to $3.7 million for the comparable prior year period. The decrease was primarily due to cost savings related to D&O insurance premiums and reductions in professional services.

Net loss: The Company reported a net loss of $7.7 million, or $0.27 per basic and diluted common share, for the three months ended June 30, 2023, compared to a net loss of $7.2 million, or $0.38 per basic and diluted common share, for the comparable prior year period.
Cash position: As of June 30, 2023, the Company had cash of $17.0 million, compared to $10.9 million as of March 31, 2023.

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)

 

 

 

June 30,

 

 

 

 

 

 

2023

 

 

December 31,

 

 

 

(unaudited)

 

 

2022

 

Assets

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

Cash

 

$

16,993

 

 

$

18,182

 

Prepaid expenses and other current assets

 

 

2,472

 

 

 

4,052

 

Total Current Assets

 

 

19,465

 

 

 

22,234

 

Non-current assets

 

 

 

 

 

 

Property and equipment, net

 

 

3,977

 

 

 

4,397

 

Construction in progress

 

 

93

 

 

 

29

 

Restricted cash

 

 

253

 

 

 

252

 

Right-of-use assets - finance leases

 

 

1,817

 

 

 

1,691

 

Right-of-use assets - operating leases

 

 

3,858

 

 

 

4,181

 

Other non-current assets

 

 

255

 

 

 

255

 

Total Non-Current Assets

 

 

10,253

 

 

 

10,805

 

Total Assets

 

$

29,718

 

 

$

33,039

 

Liabilities and Stockholders' Equity

 

 

 

 

 

 

Liabilities

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

Accounts payable

 

$

585

 

 

$

2,091

 

Accrued expenses and other current liabilities

 

 

1,674

 

 

 

2,342

 

Short-term finance lease liability

 

 

765

 

 

 

682

 

Short-term operating lease liability

 

 

757

 

 

 

707

 

Total Current Liabilities

 

 

3,781

 

 

 

5,822

 

Long-term finance lease liability

 

 

861

 

 

 

811

 

Long-term operating lease liability

 

 

3,277

 

 

 

3,674

 

Total Non-Current Liabilities

 

 

4,138

 

 

 

4,485

 

Total Liabilities

 

 

7,919

 

 

 

10,307

 

Stockholders' Equity

 

 

 

 

 

 

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

 

 

 

 

 

 

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

 

 

4

 

 

 

3

 

Additional paid-in capital

 

 

98,247

 

 

 

83,941

 

Accumulated deficit

 

 

(76,452

)

 

 

(61,212

)

Total Stockholders' Equity

 

 

21,799

 

 

 

22,732

 

Total Liabilities and Stockholders' Equity

 

$

29,718

 

 

$

33,039

 

 


IN8BIO, INC.

STATEMENTS OF OPERATIONS

(In thousands, except share and per share data)

(Unaudited)

 

 

Three Months Ended
June 30,

 

 

Six Months Ended
June 30,

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

Research and development

$

4,134

 

 

$

3,504

 

 

$

8,519

 

 

$

5,885

 

General and administrative

 

3,581

 

 

 

3,675

 

 

 

7,051

 

 

 

7,439

 

Total operating expenses

 

7,715

 

 

 

7,179

 

 

 

15,570

 

 

 

13,324

 

Other income

 

 

 

 

 

 

 

330

 

 

 

 

Loss from operations

 

(7,715

)

 

 

(7,179

)

 

 

(15,240

)

 

 

(13,324

)

Net loss

$

(7,715

)

 

$

(7,179

)

 

$

(15,240

)

 

$

(13,324

)

Net loss per share – basic and diluted

$

(0.27

)

 

$

(0.38

)

 

$

(0.57

)

 

$

(0.71

)

Weighted-average number of shares used in computing net loss per common share, basic and diluted

 

28,472,346

 

 

 

18,828,680

 

 

 

26,612,794

 

 

 

18,814,691

 

 

 

 

 

 

Company Contact:
IN8bio, Inc.
Patrick McCall

+ 1 646.600.6GDT (6438)

info@IN8bio.com

 

Investors & Media Contact:
Argot Partners

IN8bio@argotpartners.com