Zacks Small Cap Analysis – INAB: Upcoming Displays at SNO & ASH – Cyber Tech

By John Vandermosten, CFA

NASDAQ:INAB

READ THE FULL INAB RESEARCH REPORT

IN8bio, Inc (NASDAQ:INAB) reported third quarter 2024 monetary outcomes and achievements on November 12^th. Exercise because the second quarter replace was dominated by a restructuring and narrowing of focus in direction of the INB-100 program and the increase of $12.4 million in a personal placement. The corporate additionally introduced its anticipated attendance on the Society for Neuro-Oncology (SNO) and American Society of Hematology (ASH) annual conferences to current particulars on the INB-200 and INB-100 applications respectively.

IN8bio reported third quarter 2024 earnings together with the submitting of its Type 10-Q on November 12^th. IN8bio generated no revenues in 3Q:24 and incurred working expense of $7.1 million, producing a web lack of ($7.1) million or ($0.15) per share.

For the quarter ending September 30^th, 2024 and versus the identical comparable prior 12 months interval:

• Analysis & improvement bills totaled $3.3 million, contracting 13% from $3.8 million attributable to a pointy fall in personnel bills and INB-200 exercise. This was offset by a rise in INB-400 and INB-100 spending. Throughout the quarter, the corporate introduced that the INB-400 program can be suspended;
• Common & administrative bills had been $2.7 million, falling 19% from $3.4 million. The lower was primarily attributable to decrease salaries and bonus on account of the workforce discount and value financial savings associated to administrators’ and officers’ insurance coverage premiums, partially offset by a rise in skilled companies;
• $1.1 million of severance and associated costs was acknowledged in comparison with $0 within the prior 12 months associated to the restructuring introduced in September;
• Curiosity revenue was $23,000 versus $0 with the contribution associated to curiosity paid on money balances;
• Web loss was ($7.1) million, or ($0.15) per share, in comparison with ($7.2) million, or ($0.23) per share.

On the finish of 3Q:24, money and marketable securities totaled $4.0 million, in comparison with 12 months finish 2023 money steadiness of $21.3 million. Money burn for the primary 9 months of 2024 was ($20.3) million versus ($19.0) million within the comparable prior 12 months interval. Following the top of the quarter, the corporate carried out a personal placement that raised a web $11.6 million. Administration anticipates that the money steadiness is adequate to assist firm operations till December 2025.

INB-100

Now that IN8bio’s focus is solely on the INB-100 program, the corporate’s monetary and administration sources might be directed in direction of populating the growth cohort. The workforce met with the FDA in a Kind B assembly to assist information the design of the registrational path for INB-100 in acute myeloid leukemia (AML). 25 further sufferers might be added on the beneficial Section II dose. This portion of the trial is anticipated to be full by 1H:25 with long run comply with up outcomes out there by late 2025 and in 2026. IN8bio is in search of new facilities so as to add to its lively Westwood, Kansas location. The trial can even consider a potential parallel observational cohort as a management.

Restructuring

IN8bio introduced a restructuring in a September 4^thpress launch indicating that the corporate will deal with the INB-100 program for AML. Because of the troublesome financing surroundings and investor lack of curiosity in pursuing a glioblastoma multiforme (GBM) program, IN8bio has determined to severely reduce prices and focus its remaining sources on the very profitable AML program which has noticed 100% development free survival. This narrowing of focus has allowed the corporate to execute a $12.4 million non-public placement led by a accomplice healthcare-focused institutional agency and different buyers.

On account of this resolution to streamline the corporate, the corporate reduce its workforce by half at each the New York and Birmingham places of work together with a discount of money compensation for the manager administration workforce and board. Personnel cuts embrace the corporate’s Chief Medical Officer. Restructuring prices might be money expense of $0.3 million and incurred within the third quarter of 2022. On a GAAP foundation, the quantity was recorded at $1.1 million, with the bulk being non-cash and comprised of accelerated stock-based compensation.

The GBM program was reduce as a result of it didn’t obtain investor credit score and was additionally going to be dearer than the AML program. The trial measurement that will have been essential to persuade buyers and the FDA that INB-400 may generate pivotal knowledge would have required a bigger capital increase than is now possible. This system has been paused, however administration is optimistic that with the robust outcomes both a accomplice might be discovered or investor curiosity resumes. Information on the GBM program will proceed and IN8bio’s knowledge for INB-200 might be offered on the Society for Neuro Oncology (SNO) annual assembly by Dr. Mina Lobbous on November 23^rd. This oral presentation is titled: INB-200: Absolutely Enrolled Section 1 Examine of Gene-Modified Autologous Gamma-Delta (γδ) T Cells in Newly Recognized Glioblastoma Multiforme (GBM) Sufferers Receiving Upkeep Temozolomide (TMZ). With the wind down of the INB-400 trial, IN8bio analysis and improvement will now be solely targeted on the INB-100 program which supplied its most up-to-date replace in mid-August.    

Personal Placement

On October 1^st, IN8bio introduced pricing for a personal placement of $12.4 million, earlier than charges and bills. Capital suppliers for the deal embrace present healthcare-focused institutional buyers, a big mutual fund and different present and new institutional buyers. Web proceeds are anticipated to fund firm operations into 2026.

Below the phrases of the settlement, IN8bio will promote 25,759,595 shares of frequent inventory and 5,646,853 pre-funded warrants as a unit mixed with a warrant at a purchase order value of $0.395 ($0.3949 for the pre-funded warrants). Every of the 31.4 million shares or prefunded warrants may have a warrant hooked up with an train value of $0.27 and a three-year length. Together with the non-public placement, the phrases of the collection A standard inventory buy warrants issued along with the December 2023 capital increase had been modified. The train value strikes from $1.25 to $0.45 and the expiration strikes from June 2025 to October 2025.

The capital will assist the additional medical improvement of INB-100 and the continued enrollment of sufferers within the growth cohort. Complete anticipated enrollment has been expanded to 25 sufferers on the anticipated Section II dose. Enrollment is anticipated to increase till 1H:25 with long run comply with up outcomes anticipated in late 2025 and in 2026. 

Milestones

• Future targets outlined for IN8bio – January 2024
• Current further preclinical knowledge for INB-300 (nsCAR) at AACR (poster) – April 2024
• Dosing of first affected person in INB-400 trial – April 2024
• Oral presentation at American Society of Gene & Mobile Remedy (ASGCT) – Might 2024
• Two poster shows at Worldwide Society for Cell & Gene Remedy (ISCT) – Might 2024
• ASCO INB-200 presentation – June 2024
• EHA presentation: INB-100 & -200 (necessary knowledge anticipated) – June 2024
• Attend HC Wainwright Immune Cell Engager Convention – June 2024
• IND submitting for allogeneic arms of INB-400 – 2025
• August 1^st, 2024 affected person survival replace for INB-100 & INB-200 – August 2024
• Restructuring and narrowing of focus to INB-100 AML program – September 2024
• $12.4 million capital increase – October 2024
• SNO Plenary Oral Presentation – November 2024
• ASH presentation on INB-100 – December 2024
• Topline announcement for INB-100 growth cohort – 2025
• Submission of IND Section II in AML – 1H:25

Abstract

IN8bio made some powerful selections on its pipeline and personnel given the troublesome funding surroundings and lack of worth recognition for its GBM program. We anticipate to see sources directed in direction of the INB-100 program, which has proven spectacular outcomes. This restructuring was adopted by a capital increase that can assist an growth of the Section I trial from ten topics to 25 and the addition of ten AML sufferers who will function a management. Profitable outcomes on this endeavor may assist a a lot stronger capital increase in 2026 that can permit a proof-of-concept trial to be run. With profitable Section II outcomes, INB-100 may obtain expedited remedy by the FDA.

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