IN8BIO INC

Previous wording

We recently dosed the first patient 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 autologous, 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 known as INB-200. We have completed enrollment of Cohort 3 for INB-200 and will provide clinical updates and long-term follow-up data at medical meetings throughout 2024, starting with a presentation at the American Society of Clinical Oncology ("ASCO") Annual Meeting in June 2024. We presented an interim clinical update to INB-200 in an oral presentation at the ASCO Annual Meeting in June 2023 and an update via poster at the Society of Neuro-Oncology ("SNO") Annual Meeting in November 2023. In addition, with additional funding, we plan to submit an IND in 2025 for the Phase 1b/2 clinical trial of INB-400 in which allogeneic genetically modified gamma-delta T cells will be assessed in patients with recurrent and newly diagnosed GBM. Should a favorable safety profile be determined in the Phase 1b recurrent GBM portion of the study, we expect to initiate the Phase 2 expansion portion, whereby GBM patients with recurrent and newly diagnosed GBM would both be eligible to receive the allogeneic genetically modified gamma-delta T cell product. In April 2023, we received Orphan Drug Designation ("ODD") for the autologous and allogeneic INB-400 products from the FDA, covering a broad range of malignant glioma indications, including relapsed and newly diagnosed GBM.

Current wording

With additional funding, we plan to submit an IND for the allogeneic arm of INB-400 in 2025, a phase 1b/2 clinical trial in which allogeneic genetically modified gamma-delta T cells will be assessed in patients with recurrent and newly diagnosed GBM. Should a favorable safety profile be determined in the Phase 1b recurrent GBM portion of the study, we expect to initiate the Phase 2 expansion portion, whereby GBM patients with recurrent and newly diagnosed GBM would both be eligible to receive the allogeneic genetically modified gamma-delta T cell product. In April 2023, we received Orphan Drug Designation ("ODD") 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

The complete remission ("CR") 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 updated data is expected to be presented at medical meetings in 2024, starting with the European Hematological Association Congress ("EHA") in June 2024 with additional long-term follow-up results expected in late 2024 and in 2025.

Current 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.

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 T cell ("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 2024.

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 ("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.

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 iVd2+ 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 cells with the cryopreserved Vd1+ gamma-delta T cells showing comparable cytotoxicity to fresh cells, which allows them to be expanded and banked for potential on-demand clinical use. These data highlight our 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 ("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.

Previous wording

We intend to continue advancing our internal research, including the application of our proprietary DeltEx technologies into additional solid tumor indications with additional funding. We plan to file several company-sponsored IND applications for our pipeline product candidates over the next few years. We have also been advancing our manufacturing capabilities through process development and deeper characterization and profiling of our clinical-scale manufactured products. We will have an oral presentation at the American Society of Gene & Cellular Therapy ("ASGCT") Annual Meeting in May 2024 on the characterization of DeltEx DRI products manufactured from healthy donors and patients. We will also have two poster presentations at the International Society for Cell & Gene Therapy ("ISCT") Annual Meeting in May 2024. We will be presenting one poster on the logistical and manufacturing scale-up for the multi-center INB-400 Phase 2 trial and one poster on characterization of our manufactured products from healthy donors and cancer patients highlighting modulation in gene regulation throughout the manufacturing process.

Current wording

We intend to continue advancing our internal research, including the application of our proprietary DeltEx technologies into additional solid tumor indications with additional funding. We seek to file several company-sponsored IND applications for our pipeline product candidates over the next few years. We have also been advancing our manufacturing capabilities through additional process development along with deeper characterization and profiling of our clinical-scale manufactured products. We presented a comprehensive characterization of DeltEx drug-resistant immunotherapy ("DRI") products manufactured from healthy donors and patients at the American Society of Gene & Cellular Therapy ("ASGCT") Annual Meeting in May 2024. We also presented two posters at the International Society for Cell & Gene Therapy ("ISCT") Annual Meeting in May 2024, one describing the logistical and manufacturing scale-up for the multi-center INB-400 Phase 2 trial and the second characterizing manufactured products from healthy donors and cancer patients highlighting modulation in gene regulation throughout the manufacturing process.

Previous wording

Research and development expenses were $4.9 million for the three months ended March 31, 2024, compared to $4.4 million for the comparable prior year period. The increase of $0.5 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 $0.1 million due to costs for INB-100, INB-200 and INB-400.

Current 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.

Previous wording

General and administrative expenses were $3.7 million for the three months ended March 31, 2024, compared to $3.5 million for the comparable prior year period. The increase of $0.3 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 $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.

Previous wording

We did not have other income for the three months ended March 31, 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 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.

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 $115.8 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 $119.4 million of gross proceeds from the sale of our securities.

Previous wording

As of March 31, 2024, we had cash of $13.0 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 advancing our other product candidates, including our preclinical pipeline and our internal research and development capabilities and seek potential collaborative partners for our earlier stage assets. Based on this business strategy, our existing cash as of March 31, 2024 will only fund the projected operating expenses and capital expenditure requirements into January 2025.

Current 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.

Previous wording

In November 2022, we filed a shelf registration statement on Form S-3 (File No. 333-268288) (Shelf Registration Statement) 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. Through May 2, 2024, we sold an aggregate of 856,624 shares of our common stock under the ATM program, resulting in net proceeds of approximately $1.0 million after deducting underwriting discounts. 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.

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 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.

Previous wording

As of March 31, 2024, we had issued and outstanding 574,241 pre-funded warrants, 11,823,829 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 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.

Previous wording

The Series A warrants are exercisable immediately and will expire on June 13, 2025. We have the option to cause the Series A warrants to be mandatorily exercised at a strike price of $1.25 per share upon the public announcement of INB-100 clinical data for the 10 currently enrolled patients, should they remain alive and evaluable, covering a period of at least 11 months, along with certain stock price and trading volume requirements. The Series B warrants are exercisable immediately and will expire on December 13, 2028. The Series B warrants allow us to mandatorily redeem such warrants at a price of $0.01 per Series B warrant upon the public announcement of our INB-100 data for all enrolled patients covering a period of at least 22 months, along with certain stock price and trading volume requirements. Holders of Series B warrants may choose to exercise such warrants at a purchase price of $1.50 per share prior to such redemption.

Current wording

The Series A warrants are exercisable immediately and will expire on June 13, 2025. The Series B warrants are exercisable immediately and will expire on December 13, 2028. The Series B warrants allow us to mandatorily redeem such warrants at a price of $0.01 per Series B warrant upon the public announcement of our INB-100 data for all enrolled patients covering a period of at least 22 months, along with certain stock price and trading volume requirements. Holders of Series B warrants may choose to exercise such warrants at a purchase price of $1.50 per share prior to such redemption.

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.

Current 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.

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. Based on our business strategy, our existing cash of $13.0 million as of March 31, 2024 will only fund the projected operating expenses and capital expenditure requirements into January 2025. 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 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, 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.

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 ordinary warrants exercise their warrants pursuant to the mandatory exercise feature, which is triggered upon our public announcement of INB-100 data for the 10 currently enrolled patients, should they remain alive and evaluable, covering a period of at least 11 months of long-term follow-up for each patient, along with certain stock price and trading volume requirements. 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 or delaying, reducing the scope of, discontinuing or altering our research and development activities.

Current 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.

Previous wording

The actual amount of cash that we will need to operate is subject to many factors, including those described in the section titled “Risk Factors.” The condensed financial statements have been prepared on the basis that we will continue as a going concern and do not include adjustments that might result from the outcome of this uncertainty.

Current wording

The condensed financial statements have been prepared on the basis that we will continue as a going concern and do not include adjustments that might result from the outcome of this uncertainty.

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 recent bank failures, public health crises such as the COVID-19 pandemic 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 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.

Previous wording

Our material cash requirements as of March 31, 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 March 31, 2024, we had fixed lease payment obligations of $7.2 million, with $2.1 million payable within 12 months. Refer to Note 12 to our condensed financial statements for additional information.

Current 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.

Previous wording

Cash used in operating activities was $7.9 million during the three months ended March 31, 2024, primarily due to our net loss of $8.6 million and changes in operating assets and liabilities of $1.1 million, partially offset by an increase in non-cash charges of $1.9 million. Decreases in our operating assets and liabilities consisted primarily of $2.1 million in accrued expenses and other current liabilities relating primarily to accrued compensation, accrued clinical trials, and accrued legal and $0.2 million in long-term operating liabilities, partially offset by an increase of $0.8 million in prepaid expenses and other current assets and $0.5 million in accounts payable. Increases in our non-cash charges consisted primarily of $1.2 million in stock-based compensation due to increased employee headcount resulting from growth in our business, $0.4 million in amortization of right-of-use assets associated with our operating and finance leases for the period and $0.2 million of depreciation.

Current 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.

Previous wording

Cash used in operating activities was $7.4 million during the three months ended March 31, 2023, primarily due to our net loss of $7.5 million and changes in operating assets and liabilities of $1.4 million, partially offset by an increase in non-cash charges of $1.5 million. Decrease in our operating assets and liabilities consisted primarily of $1.0 million in accounts payable, $0.7 million in accrued expenses and other current liabilities relating to accrued leasehold improvements and accrued manufacturing costs and $0.2 million in long-term operating liabilities, partially offset by $0.5 million in prepaid expenses and other current assets. Increases in our non-cash charges consisted primarily of $0.9 million in stock-based compensation due to increased employee headcount resulting from growth in our business, $0.4 million in amortization of operating and finance leases for the quarter and $0.2 million of depreciation.

Current 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.

Previous wording

Cash used in investing activities was $0.1 million during the three months ended March 31, 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 six months ended June 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 $0.4 million during the three months ended March 31, 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 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.

Previous wording

Cash used in financing activities was $0.3 million during the three months ended March 31, 2024, primarily due to principal payments of $0.2 million on our leases and $0.1 million of issuance costs.

Current 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.

Previous wording

Cash provided by financing activities was $0.5 million during the three months ended March 31, 2023, primarily due to proceeds received from the issuance and sale of common stock pursuant to the ATM program of $0.7 million offset by principal payments of $0.2 million on our leases.

Current 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.