INAB: Upcoming Presentations at SNO & ASH

By John Vandermosten, CFA

NASDAQ:INAB

READ THE FULL INAB RESEARCH REPORT

IN8bio, Inc (NASDAQ:INAB) reported third quarter 2024 financial results and achievements on November 12^th. Activity since the second quarter update was dominated by a restructuring and narrowing of focus towards the INB-100 program and the raise of $12.4 million in a private placement. The company also announced its anticipated attendance at the Society for Neuro-Oncology (SNO) and American Society of Hematology (ASH) annual meetings to present details on the INB-200 and INB-100 programs respectively.

IN8bio reported third quarter 2024 earnings along with the filing of its Form 10-Q on November 12^th. IN8bio generated no revenues in 3Q:24 and incurred operating expense of $7.1 million, producing a net loss of ($7.1) million or ($0.15) per share.

For the quarter ending September 30^th, 2024 and versus the same comparable prior year period:

• Research & development expenses totaled $3.3 million, contracting 13% from $3.8 million due to a sharp fall in personnel expenses and INB-200 activity. This was offset by an increase in INB-400 and INB-100 spending. During the quarter, the company announced that the INB-400 program would be suspended;
• General & administrative expenses were $2.7 million, falling 19% from $3.4 million. The decrease was primarily due to lower salaries and bonus as a result of the workforce reduction and cost savings related to directors’ and officers’ insurance premiums, partially offset by an increase in professional services;
• $1.1 million of severance and related charges was recognized compared to $0 in the prior year related to the restructuring announced in September;
• Interest income was $23,000 versus $0 with the contribution related to interest paid on cash balances;
• Net loss was ($7.1) million, or ($0.15) per share, compared to ($7.2) million, or ($0.23) per share.

At the end of 3Q:24, cash and marketable securities totaled $4.0 million, compared to year end 2023 cash balance of $21.3 million. Cash burn for the first nine months of 2024 was ($20.3) million versus ($19.0) million in the comparable prior year period. Following the end of the quarter, the company conducted a private placement that raised a net $11.6 million. Management anticipates that the cash balance is sufficient to support company operations until December 2025.

INB-100

Now that IN8bio’s focus is solely on the INB-100 program, the company’s financial and management resources will be directed towards populating the expansion cohort. The team met with the FDA in a Type B meeting to help guide the design of the registrational path for INB-100 in acute myeloid leukemia (AML). 25 additional patients will be added at the recommended Phase II dose. This portion of the trial is anticipated to be complete by 1H:25 with long term follow up results available by late 2025 and in 2026. IN8bio is looking for new centers to add to its active Westwood, Kansas location. The trial will also evaluate a prospective parallel observational cohort as a control.

Restructuring

IN8bio announced a restructuring in a September 4^thpress release indicating that the company will focus on the INB-100 program for AML. Due to the difficult financing environment and investor lack of interest in pursuing a glioblastoma multiforme (GBM) program, IN8bio has decided to severely cut costs and focus its remaining resources on the very successful AML program which has observed 100% progression free survival. This narrowing of focus has allowed the company to execute a $12.4 million private placement led by a partner healthcare-focused institutional firm and other investors.

As a result of this decision to streamline the company, the company cut its workforce by half at both the New York and Birmingham offices along with a reduction of cash compensation for the executive management team and board. Personnel cuts include the company’s Chief Medical Officer. Restructuring costs will be cash expense of $0.3 million and incurred in the third quarter of 2022. On a GAAP basis, the amount was recorded at $1.1 million, with the majority being non-cash and comprised of accelerated stock-based compensation.

The GBM program was cut because it failed to receive investor credit and was also going to be more expensive than the AML program. The trial size that would have been necessary to convince investors and the FDA that INB-400 could generate pivotal data would have required a larger capital raise than is now feasible. The program has been paused, but management is optimistic that with the strong results either a partner will be found or investor interest resumes. News on the GBM program will continue and IN8bio’s data for INB-200 will be presented at the Society for Neuro Oncology (SNO) annual meeting by Dr. Mina Lobbous on November 23^rd. This oral presentation is titled: INB-200: Fully Enrolled Phase 1 Study of Gene-Modified Autologous Gamma-Delta (γδ) T Cells in Newly Diagnosed Glioblastoma Multiforme (GBM) Patients Receiving Maintenance Temozolomide (TMZ). With the wind down of the INB-400 trial, IN8bio research and development will now be solely focused on the INB-100 program which provided its most recent update in mid-August.    

Private Placement

On October 1^st, IN8bio announced pricing for a private placement of $12.4 million, before fees and expenses. Capital providers for the deal include existing healthcare-focused institutional investors, a large mutual fund and other existing and new institutional investors. Net proceeds are expected to fund company operations into 2026.

Under the terms of the agreement, IN8bio will sell 25,759,595 shares of common stock and 5,646,853 pre-funded warrants as a unit combined with a warrant at a purchase price of $0.395 ($0.3949 for the pre-funded warrants). Each of the 31.4 million shares or prefunded warrants will have a warrant attached with an exercise price of $0.27 and a three-year duration. Along with the private placement, the terms of the series A common stock purchase warrants issued in conjunction with the December 2023 capital raise were modified. The exercise price moves from $1.25 to $0.45 and the expiration moves from June 2025 to October 2025.

The capital will support the further clinical development of INB-100 and the continued enrollment of patients in the expansion cohort. Total expected enrollment has been expanded to 25 patients at the anticipated Phase II dose. Enrollment is expected to extend until 1H:25 with long term follow up results anticipated in late 2025 and in 2026. 

Milestones

• Future goals outlined for IN8bio – January 2024
• Present additional preclinical data for INB-300 (nsCAR) at AACR (poster) – April 2024
• Dosing of first patient in INB-400 trial – April 2024
• Oral presentation at American Society of Gene & Cellular Therapy (ASGCT) – May 2024
• Two poster presentations at International Society for Cell & Gene Therapy (ISCT) – May 2024
• ASCO INB-200 presentation – June 2024
• EHA presentation: INB-100 & -200 (important data expected) – June 2024
• Attend HC Wainwright Immune Cell Engager Conference – June 2024
• IND filing for allogeneic arms of INB-400 – 2025
• August 1^st, 2024 patient survival update for INB-100 & INB-200 – August 2024
• Restructuring and narrowing of focus to INB-100 AML program – September 2024
• $12.4 million capital raise – October 2024
• SNO Plenary Oral Presentation – November 2024
• ASH presentation on INB-100 – December 2024
• Topline announcement for INB-100 expansion cohort – 2025
• Submission of IND Phase II in AML – 1H:25

Summary

IN8bio made some tough decisions on its pipeline and personnel given the difficult funding environment and lack of value recognition for its GBM program. We expect to see resources directed towards the INB-100 program, which has shown impressive results. This restructuring was followed by a capital raise that will support an expansion of the Phase I trial from ten subjects to 25 and the addition of ten AML patients who will serve as a control. Successful results in this endeavor could support a much stronger capital raise in 2026 that will allow a proof-of-concept trial to be run. With successful Phase II results, INB-100 could receive expedited treatment by the FDA.

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