IN8BIO INC

Previous wording

We are 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. They are naturally occurring immune cells that can intrinsically differentiate between healthy and diseased tissue. These cells serve as a functional bridge between innate and adaptive immunity to contribute to direct tumor killing, as well as immune cell recruitment and activation to drive deeper and more comprehensive immune responses. The pivotal role of gamma-delta T cells in immune function and activation, against diseases such as cancer, underscores their therapeutic potential across a wide range of solid and hematologic malignancies. We develop ex vivo-expanded and activated gamma-delta T cell candidates based upon our deep expertise in gamma-delta T cell biology, proprietary genetic engineering, and cell-type specific manufacturing capabilities, which we refer to collectively as our DeltEx platform. Our platform employs allogeneic, autologous, induced pluripotent stem cell ("iPSC") and genetically modified cell therapy approaches that are designed to effectively identify and eradicate tumor cells. We are the most clinically advanced gamma-delta T cell focused cellular therapy company and are utilizing our suite of DeltEx platform technologies as we aspire to eliminate cancer cells to achieve our mission of what we refer to as Cancer Zero ─ the safe elimination of all cancer cells in every patient battling the disease. We believe this lofty aspiration will one day be achievable, and that it is our responsibility to directly contribute to related global health efforts by pursuing scientific research that will advance cancer treatment.

Current wording

We are 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. They are naturally occurring immune cells that can intrinsically differentiate between healthy and diseased tissue. These cells serve as a functional bridge between innate and adaptive immunity to contribute to direct tumor killing, as well as immune cell recruitment and activation to drive deeper and more comprehensive immune responses. The pivotal role of gamma-delta T cells in immune function and activation, against diseases such as cancer, underscores their therapeutic potential across a wide range of solid and hematologic malignancies. We develop ex vivo expanded and activated gamma-delta T cell candidates based upon our deep expertise in gamma-delta T cell biology, proprietary genetic engineering, and cell-type specific manufacturing capabilities, which we refer to collectively as our DeltEx platform. Our platform employs allogeneic, autologous, induced pluripotent stem cell ("iPSC"), genetically modified cell therapy approaches and T cell engagers that are designed to effectively identify and eradicate tumor cells. We are the most clinically advanced gamma-delta T cell-focused company and are utilizing our suite of DeltEx platform technologies as we aspire to eliminate cancer cells to achieve our mission of what we refer to as Cancer Zero ─ the safe elimination of all cancer cells in every patient battling the disease. We believe this lofty aspiration will one day be achievable, and that it is our responsibility to directly contribute to related global health efforts by pursuing scientific research that will advance cancer treatment.

Previous wording

The investigator-initiated Phase 1 trial of INB-100 for treatment of patients with high-risk leukemias undergoing hematopoietic stem cell transplantation ("HSCT") has completed primary enrollment and a recommended Phase 2 dose ("RP2D") has been determined. The relapse free survival data to date, combined with INB-100’s benefit/risk profile, are encouraging for the treatment of hematological malignancies, and the trial is being expanded by an additional ten patients at Dose Level ("DL") 2, the RP2D. Enrollment in the expansion cohort is on-going, and we expect to present updated data at medical meetings in the second half of 2024 and throughout 2025. In June 2024, updated data were presented at the European Hematological Association Congress ("EHA"). This data demonstrated that 100% of evaluable leukemia patients (n=10) remained alive, progression-free, and in durable complete remission through one year as of May 31, 2024. Further, across these 10 patients, gamma-delta T cells demonstrated in vivo expansion and long-term persistence through 365 days, a first for any donor-derived, allogeneic cellular therapy product. Additional long-term follow-up results are expected in late 2024 and in 2025. In addition, with additional funding, we plan to submit an IND with the FDA for a registrational Phase 2 clinical trial for patients with acute myeloid leukemia (“AML”) undergoing their first allogeneic transplant using reduced intensity conditioning regimen.

Current wording

The investigator-initiated Phase 1 trial of INB-100 for treatment of patients with high-risk leukemias undergoing hematopoietic stem cell transplantation has completed primary enrollment, and a recommended Phase 2 dose ("RP2D") has been determined. We believe the relapse free survival data to date, combined with the benefit/risk profile of INB-100, are encouraging for the treatment of hematological malignancies, and the trial is being expanded by additional patients at Dose Level 2, the RP2D. Enrollment in the expansion cohort is on-going, and we expect to present updated data at the American Society of Hematology Annual Meeting in December 2024 and other medical meetings throughout 2025. In June 2024, updated data were presented at the European Hematological Association Congress. These data demonstrated that 100% of evaluable leukemia patients (n=10) remained alive, progression-free, and in durable complete remission through one year as of May 31, 2024. As of August 30, 2024, 100% of patients with acute myeloid leukemia ("AML") remain relapse-free after receiving their dose of INB-100 after a median follow-up of 18.7 months. The two previously reported patients with other leukemic diagnoses (ALL and MDS/MPN overlap with concurrent TP53 mutations), both excluded from future pivotal trials, have since relapsed and died due to disease progression. There have been no new relapses reported since the update in June 2024. Further, across these 10 patients, gamma-delta T cells demonstratedin vivo expansion and long-term persistence through 365 days, a first for any donor-derived, allogeneic cellular therapy product. The INB-100 trial will continue to enroll patients in the expansion cohort with a new target total enrollment of up to approximately 25 patients at the RP2D. Additional long-term follow-up results are expected in late 2024 and in 2025.

Previous wording

We have begun dosing patients in our Phase 2 multi-center clinical trial of our lead product candidate, INB-400, for the treatment of newly diagnosed glioblastoma ("GBM"). This trial will expand the assessment of genetically modified gamma-delta T cells in newly diagnosed GBM patients in specialized brain tumor centers across the United States. We anticipate that the Phase 2 trial will confirm the efficacy signal suggested by the investigator-initiated Phase 1 trial of INB-200 (NCT04165941). The investigator-initiated trial has completed enrollment of Cohort 3; clinical updates and long-term follow-up data will be provided at medical meetings in the second half of 2024 and throughout 2025. In June 2024, preliminary clinical data were presented at the American Society of Clinical Oncology ("ASCO") Annual Meeting, demonstrating that 92% of evaluable patients treated in the investigator-initiated trial exceeded the median progression-free survival ("PFS") of 7 typically months achieved by standard-of-care therapy with concomitant temozolomide (“TMZ”).

Current wording

In September 2024, we suspended further enrollment of patients in our Phase 2 multi-center clinical trial of INB-400, for the treatment of newly diagnosed glioblastoma ("GBM"). This trial sought to expand the assessment of genetically modified, drug-resistant immunotherapy (“DRI”) gamma-delta T cells in newly diagnosed GBM patients in specialized brain tumor centers across the United States. We will continue to follow these patients for safety, progression-free and overall survival. We have completed patient dosing in the investigator-initiated Phase 1 trial of INB-200 (NCT04165941). We will present a Plenary Oral Presentation at the Society of Neuro-Oncology Annual Meeting in November 2024 where we will provide longer-term follow-up and additional data supporting the activity of our DRI gamma-delta T cell approach from the Phase 1 trial of INB-200. In June 2024, preliminary clinical data were presented at the American Society of Clinical Oncology Annual Meeting, demonstrating that 92% of evaluable patients treated in the investigator-initiated trial exceeded the median progression-free survival ("PFS") of 7 typically months achieved by standard-of-care therapy with concomitant temozolomide. We believe our DRI gamma-delta T cell therapeutic approach is applicable to multiple solid tumor types and will seek strategic alternatives and to potentially partner this program. In April 2023, we received Orphan Drug Designation for the autologous and allogeneic INB-400 products from the Food and Drug Administration (“FDA”), covering a broad range of malignant glioma indications, including relapsed and newly diagnosed GBM.

Previous wording

We also have a portfolio of preclinical programs in development, including INB-300, which focuses on targeting various solid and liquid tumors using a dedicated non-signaling gamma-delta T cell based chimeric antigen receptor ("nsCAR") construct. We presented additional preclinical data demonstrating our proof-of-concept in vitro studies, run in triplicate, against the leukemia antigen targets CD33 and CD123, which demonstrated the ability of our nsCAR constructs to distinguish between tumor and healthy tissue at the American Association for Cancer Research ("AACR") Annual Meeting in 2024. We plan to continue to optimize the construct for advancement towards animal models and potentially IND enabling studies in late 2024 or early 2025.

Current wording

We also have a portfolio of preclinical programs in development, including INB-300, which focuses on targeting various solid and liquid tumors using a dedicated non-signaling gamma-delta T cell based chimeric antigen receptor ("nsCAR") construct. We presented additional preclinical data demonstrating our proof-of-concept in vitro studies, run in triplicate, against the leukemia antigen targets CD33 and CD123, which demonstrated the ability of our nsCAR constructs to distinguish between tumor and healthy tissue, at the American Association for Cancer Research Annual Meeting in 2024. We plan to continue to optimize the construct for advancement towards animal models, potentially IND enabling studies and opportunities for potential partnership.

Previous wording

In May 2022, we unveiled the expansion of our DeltEx platform capabilities to include iPSC derived gamma-delta T cells. iPSCs represent a significant step toward next generation approaches of cellular manufacturing for true allogeneic and potentially ‘off-the-shelf’ innate cell therapies. We provided updates in a presentation at the Society for Immunotherapy of Cancer ("SITC") Annual Meeting in November 2023 whereby to date, hundreds of millions of our iPSC derived iVdelta1+ or iVd1+ gamma-delta T cells have been produced from single iPSC clones at a low passage number. These cells demonstrate a profile associated with a reduced risk for cytokine release syndrome ("CRS") and robust cytotoxic activity across a variety of solid and liquid cancers, including ovarian cancer, GBM, acute myeloid leukemia ("AML") and chronic myelogenous leukemia ("CML"). Furthermore, cryopreservation did not impact the cytotoxic function of iVd1+ gamma-delta T cells with respect to fresh cells, thereby enabling batch manufacturing and storage for on-demand clinical use. These findings highlight our expertise and ability to manufacture multiple gamma-delta T cell populations in a serum and feeder free process that can be scaled for GMP manufacturing and applied as a potentially "off-the-shelf" platform for allogeneic cell therapy.

Current wording

In May 2022, we unveiled the expansion of our DeltEx platform capabilities to include iPSC derived gamma-delta T cells. iPSCs represent a significant step toward next generation approaches of cellular manufacturing for true allogeneic and potentially "off-the shelf" innate cell therapies. We provided updates in a presentation at the Society for Immunotherapy of Cancer Annual Meeting in November 2023 whereby to date, hundreds of millions of our iPSC derived iVdelta1+ or iVd1+ gamma-delta T cells have been produced from single iPSC clones at a low passage number. These cells demonstrate a profile associated with a reduced risk for cytokine release syndrome and robust cytotoxic activity across a variety of solid and liquid cancers, including ovarian cancer, GBM, AML and chronic myelogenous leukemia. Furthermore, cryopreservation did not impact the cytotoxic function of iVd1+ gamma-delta T cells with respect to fresh cells, thereby enabling batch manufacturing and storage for on-demand clinical use. These findings highlight our expertise and ability to manufacture multiple gamma-delta T cell populations in a serum and feeder free process that can be scaled for GMP manufacturing and applied as a potentially "off-the-shelf" platform for allogeneic cancer and/or autoimmune cellular therapies. We are currently seeking potential partnership opportunities for these preclinical assets.

Previous wording

Our condensed financial statements have been prepared in conformity with generally accepted accounting principles which contemplate continuation of the Company on a going concern basis. The going concern basis assumes that assets are realized, and liabilities are extinguished in the ordinary course of business at amounts disclosed in the condensed financial statements. We have not yet generated product sales and, as a result, have experienced operating losses since inception. We expect to incur additional losses in the future as we advance our product candidates through clinical trials, seek to expand our product candidate portfolio through developing additional product candidates, grow our clinical, regulatory and quality capabilities, and incur costs associated with operating as a public company. The actual amount of cash that we will need to operate is subject to many factors. Based on our business strategy, our existing cash of $10.2 million as of June 30, 2024 will fund the projected operating expenses and capital expenditure requirements into January 2025. Accordingly, there is substantial doubt about the Company’s ability to continue to operate as a going concern for a period of 12 months from the date of issuance of these condensed financial statements. We have taken measures to defer or reduce costs in the near term in order to preserve capital and increase financial flexibility. These cash preservation measures may impact our ability and the timing to execute our strategy, including our ability to achieve the anticipated milestones and the timing of patient enrollment and/or regulatory filings for our preclinical and clinical programs.

Current wording

Our condensed financial statements have been prepared in conformity with generally accepted accounting principles which contemplate continuation of the Company on a going concern basis. The going concern basis assumes that assets are realized, and liabilities are extinguished in the ordinary course of business at amounts disclosed in the condensed financial statements. We have not yet generated product sales and, as a result, have experienced operating losses since inception. We expect to incur additional losses in the future as we advance our product candidates through clinical trials, seek to expand our product candidate portfolio through developing additional product candidates, grow our clinical, regulatory and quality capabilities, and incur costs associated with operating as a public company. The actual amount of cash that we will need to operate is subject to many factors. Based on our business strategy, we expect that our existing cash of $4.0 million as of September 30, 2024, including the additional net proceeds of $11.6 million from the 2024 Private Placement, will fund the Company’s projected operating expenses and capital expenditure requirements through December 2025. Accordingly, there is substantial doubt about the Company’s ability to continue to operate as a going concern for a period of 12 months from the date of issuance of these condensed financial statements. We have taken measures to defer or reduce costs in the near term in order to preserve capital and increase financial flexibility. These cash preservation measures may impact our ability and the timing to execute our strategy, including our ability to achieve the anticipated milestones and the timing of patient enrollment and/or regulatory filings for our preclinical and clinical programs.

Previous wording

To continue to fund our operations, management has developed plans, which primarily consist of raising additional capital through some combination of equity and/or debt offerings, including through our ATM program, and identifying strategic collaborations, licensing or other arrangements to support development of our product candidates. In addition, we may receive an additional $14.8 million in aggregate proceeds if the holders of our Series A warrants exercise their warrantsi. Further, if not otherwise redeemed by us, we may also receive aggregate proceeds of up to $17.7 million from the exercise of our outstanding Series B warrants. There is no assurance, however, that we will receive any additional proceeds from these warrants or that any additional financing or any revenue-generating collaboration will be available, when needed, that management will be able to obtain financing or enter into a collaboration on terms acceptable to us, or that any additional financing or revenue generated through third-party collaborations will be sufficient to fund our operations for at least 12 months from the issuance of the condensed financial statements. If additional capital is not available to us on a timely basis, or at all, we will be required to take additional actions beyond the cost preservation measures initiated to address our liquidity needs, including exploring other strategic options, continuing to further reduce operating expense by delaying, reducing the scope of, or discontinuing our research and development activities. If the Company becomes unable to continue as a going concern, it may have to terminate its operations and dispose of its assets and might realize significantly less than the values at which they are carried on its condensed financial statements. These actions may cause the Company’s stockholders to lose all or part of their investment in the Company’s common stock.

Current wording

To continue to fund our operations, management has developed plans, which primarily consist of the pipeline prioritization and workforce reduction, raising additional capital through some combination of equity and/or debt offerings, including through our ATM program, and identifying strategic collaborations, licensing or other arrangements to support development of our product candidates. In addition, we may receive an additional $5.4 million and $12.4 million in aggregate proceeds if the holders of our Series A warrants and Series C warrants exercise their warrants, respectively. Further, if not otherwise redeemed by us, we may also receive aggregate proceeds of up to $17.7 million from the exercise of our outstanding Series B warrants. There is no assurance, however, that we will receive any additional proceeds from these warrants or that any additional financing or any revenue-generating collaboration will be available, when needed. If additional capital is not available to us on a timely basis, or at all, we will be required to take additional actions beyond the cost preservation measures initiated to address our liquidity needs, including exploring other strategic options, continuing to further reduce operating expense by delaying, reducing the scope of, or discontinuing our research and development activities. If the Company becomes unable to continue as a going concern, it may have to terminate its operations and dispose of its assets and might realize significantly less than the values at which they are carried on its condensed financial statements. These actions may cause the Company’s stockholders to lose all or part of their investment in the Company’s common stock.

Previous wording

employee-related expenses, including salaries, related-benefits and stock-based compensation expense for employees engaged in research and development functions;

Current wording

employee-related expenses, including salaries, related-benefits, severance payments and stock-based compensation expense for employees engaged in research and development functions;

Previous wording

General and administrative expenses were $7.3 million for the six months ended June 30, 2024, compared to $7.1 million for the comparable prior year period. The increase of $0.2 million was primarily due to an increase in personnel-related costs, including stock-based compensation, and rent expense, offset by cost savings related to directors' and officers' insurance premiums and a reduction in professional services.

Current wording

General and administrative expenses were $2.7 million for the three months ended September 30, 2024, compared to $3.4 million for the comparable prior year period. The decrease of $0.7 million was primarily due to a decrease in salaries and bonus as a result of our workforce reduction and cost savings related to directors' and officers' insurance premiums, partially offset by an increase in professional services.

Previous wording

The following table sets forth our results of operations for the six months ended June 30, 2024 and 2023 (in thousands):

Current wording

The following table sets forth our results of operations for the nine months ended September 30, 2024 and 2023 (in thousands):

Previous wording

The following table summarizes our research and development expenses for the six months ended June 30, 2024 and 2023 (in thousands):

Current wording

The following table summarizes our research and development expenses for the nine months ended September 30, 2024 and 2023 (in thousands):

Previous wording

Research and development expenses were $5.2 million for the three months ended June 30, 2024, compared to $4.1 million for the comparable prior year period. The increase of $1.1 million was primarily due to a $0.5 million increase in personnel-related costs, including salaries and stock-based compensation as a result of the increase in our headcount. Direct clinical costs increased by $0.5 million due to increased enrollment costs for INB-100, INB-200 and INB-400.

Current wording

Research and development expenses were $13.4 million for the nine months ended September 30, 2024, compared to $12.3 million for the comparable prior year period. The increase of $1.1 million was primarily due to an increase of $0.7 million in direct costs related to our clinical trials, primarily related to our INB-100 and INB-400 programs, and an increase of $0.4 million in personnel-related costs, including salaries, benefits and stock-based compensation as a result of the increase in our headcount period over period, partially offset by a decrease in facility-related and other expenses of $0.1 million. As a result of our pipeline prioritization announced in September 2024, future clinical work on INB-400 has been suspended.

Previous wording

Interest income was $0.1 million for the six months ended June 30, 2024. We did not have interest income for the comparable period in the prior year. The increase was due to interest income earned from cash sweep accounts, which we opened during the first quarter of 2024.

Current wording

Interest income was $0.2 million for the nine months ended September 30, 2024. We did not have interest income for the comparable period in the prior year. The increase was due to interest income earned from cash sweep accounts, which we opened during the first quarter of 2024.

Previous wording

We did not have other income for the three and six months ended June 30, 2024. The decrease of $0.3 million was due to a non-recurring contractual arrangement with a non-related third party to transfer two lots of our clinical-scale, GMP-grade gamma-delta T cells in the comparable prior year period.

Current wording

We did not have other income for the three and nine months ended September 30, 2024. The decrease of $0.3 million was due to a non-recurring contractual arrangement with a non-related third party to transfer two lots of our clinical-scale, GMP-grade gamma-delta T cells in the comparable prior year period.

Previous wording

We have funded our operations primarily through the sale of equity and equity-linked securities, including through our IPO, follow-on offerings, private placements and our ATM program. Through the date of this Quarterly Report, we have raised an aggregate of $119.4 million of gross proceeds from the sale of our securities.

Current wording

We have funded our operations primarily through the sale of equity and equity-linked securities, including through our IPO, follow-on offerings, private placements and our ATM program. Through the date of this Quarterly Report, we have raised an aggregate of $132.1 million of gross proceeds from the sale of our securities.

Previous wording

As of June 30, 2024, we had cash of $10.2 million. Our current plan of operation is to continue to implement our business strategy, including continuing clinical development of INB-400, INB-200, INB-100, and to seek potential collaborative partners for our earlier stage assets. Based on this business strategy, our existing cash as of June 30, 2024 will only fund the projected operating expenses and capital expenditure requirements into January 2025.

Current wording

As of September 30, 2024, we had cash of $4.0 million. Our current plan of operation is to continue to implement our revised business strategy, including clinical development of INB-100, and to seek potential collaborative partners for our GBM program and our earlier stage assets. Based on this business strategy, we expect that our existing cash as of September 30, 2024 plus the net proceeds from the 2024 Private Placement of $11.6 million after deducting placement agent fees and other estimated private placement expenses will fund our projected operating expenses and capital expenditure requirements through December 2025. Accordingly, there is substantial doubt about our ability to continue to operate as a going concern for a period of 12 months from the date of issuance of these condensed financial statements. For additional details, see “—Overview–Going Concern” above.

Previous wording

In November 2022, we filed a shelf registration statement on Form S-3 (File No. 333-268288) with the SEC, which permits the offering, issuance and sale by us of up to a maximum aggregate offering price of $200 million of our securities, of which $50 million of common stock may be issued and sold pursuant to an ATM program. We entered into a Controlled Equity Offering SM sales agreement, or the Sales Agreement, with Cantor Fitzgerald and Truist, under which Cantor Fitzgerald and Truist agreed to act as our sales agents to sell shares of our common stock, from time to time, through the ATM program. On March 8, 2024, we delivered a termination notice to Truist, removing them as a sales agent under the ATM program. Such termination became effective on March 14, 2024. During the three and six months ended June 30, 2024, we sold an aggregate of 3,127,331 shares of our common stock under the ATM program, resulting in net proceeds of approximately $3.5 million after deducting commissions and offering expenses.

Current wording

In November 2022, we filed a shelf registration statement on Form S-3 (File No. 333-268288) with the SEC, which permits the offering, issuance and sale by us of up to a maximum aggregate offering price of $200 million of our securities, of which $50 million of common stock may be issued and sold pursuant to an ATM program. We entered into a Controlled Equity Offering SM sales agreement, or the Sales Agreement, with Cantor Fitzgerald and Truist, under which Cantor Fitzgerald and Truist agreed to act as our sales agents to sell shares of our common stock, from time to time, through the ATM program. On March 8, 2024, we delivered a termination notice to Truist, removing them as a sales agent under the ATM program. Such termination became effective on March 14, 2024. During the nine months ended September 30, 2024, we sold an aggregate of 3,479,623 shares of our common stock under the ATM program, resulting in net proceeds of approximately $3.8 million after deducting commissions and offering expenses.

Previous wording

As of June 30, 2024, we had issued and outstanding 11,803,829 Series A warrants and 11,823,829 Series B warrants. The pre-funded warrants have an exercise price of $0.0001 per share. The Series A warrants have an exercise price of $1.25 per share. The Series B warrants have an exercise price of $1.50 per share.

Current wording

As of September 30, 2024, we had issued and outstanding 574,241 pre-funded warrants, 11,803,829 Series A warrants (subject to amendment as described below) and 11,823,829 Series B warrants. The pre-funded warrants have an exercise price of $0.0001 per share. The Series A warrants, as amended, have an exercise price of $0.45 per share. the Series B warrants have an exercise price of $1.50 per share, and the Series C warrants have an exercise price of $0.395 per share. The Series A warrants are exercisable immediately and will expire on October 4, 2025. The Series B warrants are exercisable immediately and expire on December 13, 2028. The Series C warrants are exercisable immediately and will expire on October 4, 2027.

Previous wording

We may receive up to an aggregate of approximately $32.5 million of gross proceeds from the exercise of the Series A and Series B warrants, assuming the exercise in full of all of the warrants for cash. However, we will only receive proceeds to the extent the holders of the warrants elect to exercise or, in the case of the Series A warrants, if the mandatory exercise feature is triggered. See Note 8, Warrants, to our condensed financial statements for additional information.

Current wording

We may receive up to an aggregate of approximately $17.8 million of gross proceeds from the exercise of the Series A and Series C warrants, assuming the exercise in full of all of the warrants for cash. Further, if not otherwise redeemed by us, we may also receive aggregate proceeds of up to $17.7 million from the exercise of our outstanding Series B warrants. There is no assurance, however, that we will receive any additional proceeds from these warrants or that any additional financing or any revenue-generating collaboration will be available, when needed. See Note 8, Warrants, to our condensed financial statements for additional information.

Previous wording

If we raise funds through strategic collaboration, licensing or other arrangements, we may relinquish significant rights or grant licenses on terms that are not favorable to us. Our ability to raise additional funds may be adversely impacted by potential worsening global economic conditions, increases in inflation expectations and the recent disruptions to, and volatility in, the credit and financial markets in the United States and worldwide resulting from uncertain economic conditions including inflation expectations and interest rates, the upcoming Federal election, bank failures, public health crises such as the COVID-19 pandemic, any potential for avain influenza or similar outbreak and other geopolitical tensions, such as the Israel-Hamas war and the Russia-Ukraine war. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or explore other strategic options for our product development or future commercialization efforts or grant rights to develop and market products or product candidates that we would otherwise prefer to develop and market ourselves.

Current wording

If we raise funds through strategic collaboration, licensing or other arrangements, we may relinquish significant rights or grant licenses on terms that are not favorable to us. Our ability to raise additional funds may be adversely impacted by potential worsening global economic conditions, increases in inflation expectations and the recent disruptions to, and volatility in, the credit and financial markets in the United States and worldwide resulting from uncertain economic conditions including inflation expectations and interest rates, the upcoming Federal election, bank failures, public health crises such as the COVID-19 pandemic, any potential for avian influenza or similar outbreak and other geopolitical tensions, such as the Israel-Hamas war and the Russia-Ukraine war. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or explore other strategic options for our product development or future commercialization efforts or grant rights to develop and market products or product candidates that we would otherwise prefer to develop and market ourselves.

Previous wording

Our material cash requirements as of June 30, 2024 included operating lease commitments, including the lease of our current headquarters office in New York, New York, laboratory and office space in Birmingham, Alabama and a manufacturing service agreement with a third party to engage in research of cell therapy products. As of June 30, 2024, we had fixed lease payment obligations of $7.3 million, with $2.1 million payable within 12 months. See Note 13, Equipment and Facility Leases to our condensed financial statements for additional information.

Current wording

Our material cash requirements as of September 30, 2024 included operating lease commitments, including the lease of our current headquarters office in New York, New York, laboratory and office space in Birmingham, Alabama and a manufacturing service agreement with a third party to engage in research of cell therapy products. As of September 30, 2024, we had fixed lease payment obligations of $6.7 million, with $3.2 million payable within 12 months. See Note 13, Equipment and Facility Leases to our condensed financial statements for additional information.

Previous wording

Cash used in operating activities was $14.0 million during the six months ended June 30, 2024, primarily due to our net loss of $17.2 million and changes in operating assets and liabilities of $0.5 million, partially offset by an increase in non-cash charges of $3.7 million. Decreases in our operating assets and liabilities consisted primarily of $1.4 million in accrued expenses and other current liabilities relating primarily to accrued compensation, accrued clinical trials, and accrued legal and $0.5 million in long-term operating liabilities, partially offset by an increase of $0.9 million in prepaid expenses and other current assets and $0.5 million in accounts payable. Increases in our non-cash charges consisted primarily of $2.4 million in stock-based compensation due to increased employee headcount resulting from growth in our business, $0.8 million in amortization of right-of-use assets associated with our operating and finance leases for the period and $0.5 million of depreciation.

Current wording

Cash used in operating activities was $20.1 million during the nine months ended September 30, 2024, primarily due to our net loss of $24.3 million and changes in operating assets and liabilities of $2.2 million, partially offset by an increase in non-cash charges of $6.1 million. Decreases in our operating assets and liabilities consisted primarily of $2.2 million in accrued expenses and other current liabilities relating primarily to accrued compensation, accrued clinical trials, and accrued legal, $0.7 million in long-term operating liabilities, partially offset by an increase of $0.2 million in accounts payable. Increases in our non-cash charges consisted primarily of $4.2 million in stock-based compensation due to the acceleration in full of outstanding unvested stock options as a result of our workforce reduction in September 2024, $1.2 million in amortization of right-of-use assets associated with our operating and finance leases for the period, and $0.7 million of depreciation.

Previous wording

Cash used in operating activities was $12.8 million during the six months ended June 30, 2023, primarily due to our net loss of $15.2 million and changes in operating assets and liabilities of $0.7 million, partially offset by an increase in non-cash charges of $3.1 million. Decreases in our operating assets and liabilities consisted primarily of $1.4 million in accounts payable, $0.5 million in accrued expenses and other current liabilities relating to accrued leasehold improvements and accrued manufacturing costs and $0.4 million in long-term operating liabilities, partially offset by an increase of $1.6 million in prepaid expenses and other current assets. Increases in our non-cash charges consisted primarily of $1.9 million in stock-based compensation due to increased employee headcount resulting from growth in our business, $0.7 million in amortization of operating and finance leases for the period and $0.5 million of depreciation.

Current wording

Cash used in operating activities was $18.5 million during the nine months ended September 30, 2023, primarily due to our net loss of $22.4 million and changes in operating assets and liabilities of $1.1 million, partially offset by an increase in non-cash charges of $5.0 million. Decreases in our operating assets and liabilities consisted primarily of $1.2 million in accounts payable and $0.6 million in long-term operating liabilities, partially offset by an increase of $0.3 million in prepaid expenses and other current assets, $0.3 million in accrued expenses and other current liabilities relating to accrued leasehold improvements and accrued manufacturing costs and $0.1 million in short-term operating liabilities. Increases in our non-cash charges consisted primarily of $3.1 million in stock-based compensation due to increased employee headcount resulting from growth in our business, $1.2 million in amortization of right-of-use assets associated with our operating and finance leases for the period and $0.7 million of depreciation.

Previous wording

Cash used in investing activities was $0.2 million during the six months ended June 30, 2024, primarily due to purchases of property and equipment and construction in progress activity in relation to capitalized software.

Current wording

Cash used in investing activities was $0.2 million during the nine months ended September 30, 2024, primarily due to purchases of property and equipment and construction in progress activity in relation to capitalized software.

Previous wording

Cash used in investing activities was $0.5 million during the six months ended June 30, 2023, primarily due to increased construction-in-progress activity in relation to leasehold improvements to the leased space located in Alabama.

Current wording

Cash used in investing activities was $0.5 million during the nine months ended September 30, 2023, primarily due to purchases of property and equipment and construction in progress activity in relation to leasehold improvements to the leased space located in Alabama.

Previous wording

Cash provided by financing activities was $3.1 million during the six months ended June 30, 2024, primarily due to proceeds received from the issuance and sale of common stock pursuant to the ATM program of $3.6 million, partially offset by principal payments of $0.4 million on our leases and $0.1 million of issuance costs.

Current wording

Cash provided by financing activities was $3.0 million during the nine months ended September 30, 2024, primarily due to proceeds received from the issuance and sale of common stock pursuant to the ATM program of $3.8 million, partially offset by principal payments of $0.6 million on our leases and $0.2 million of deferred issuance costs.

Previous wording

Cash provided by financing activities was $12.0 million during the six months ended June 30, 2023, primarily due to proceeds received from the issuance and sale of common stock pursuant to the ATM program of $12.4 million, partially offset by principal payments of $0.4 million on our leases.

Current wording

Cash provided by financing activities was $13.7 million during the nine months ended September 30, 2023, primarily due to proceeds received from the issuance and sale of common stock pursuant to the ATM program of $14.3 million offset by principal payments of $0.6 million on our leases.

Previous wording

As part of the process of preparing our financial statements, we are required to estimate our accrued research and development expenses. We make estimates of our accrued expenses as of each balance sheet date in the condensed financial statements based on facts and circumstances known to us at that time. There may be instances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of the expense. In accruing service fees, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, we adjust the accrual or the amount of prepaid expenses accordingly. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in reporting amounts that are too high or too low in any particular period. To date, there have not been any material adjustments to our prior estimates of accrued research and development expenses.

Current wording

As part of the process of preparing our financial statements, we are required to estimate our accrued research and development expenses. We make estimates of our accrued expenses as of each condensed balance sheet date in the condensed financial statements based on facts and circumstances known to us at that time. There may be instances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of the expense. In accruing service fees, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, we adjust the accrual or the amount of prepaid expenses accordingly. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in reporting amounts that are too high or too low in any particular period. To date, there have not been any material adjustments to our prior estimates of accrued research and development expenses.