RenovoRx Inc

Previous wording

We are a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug delivery platform for high unmet medical need with a goal to improve therapeutic outcomes for cancer patients undergoing treatment. Our proprietary Trans-Arterial Micro-Perfusion (TAMPTM) therapy platform is designed to ensure precise therapeutic delivery to directly target the tumor while potentially minimizing a therapy’s toxicities versus systemic (intravenous (“IV”) therapy). Our novel approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy.

Current wording

We are a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug delivery platform for high unmet medical need with a goal to improve therapeutic outcomes for cancer patients undergoing treatment. Our patented Trans-Arterial Micro-Perfusion (“TAMP”) therapy platform is designed to ensure precise therapeutic delivery to directly target the tumor while potentially minimizing a therapy’s toxicities versus the standard of care, systemic (intravenous (“IV”) therapy).

Previous wording

Our novel and patented approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy. Phase III lead product candidate,RenovoGem TM, an oncology drug-device combination product, is being investigated under a U.S. Investigational New Drug Application (“IND”) that is regulated by U.S. Food and Drug Administration (“FDA”) under the 21 CFR 312 pathway. RenovoGem is currently being evaluated for the treatment of locally advanced pancreatic cancer (“LAPC”) by the Center for Drug Evaluation and Research (the drug division of FDA). We also plan to evaluate RenovoGem as a potential therapy in other potential pipeline indication opportunities to follow including bile duct cancer, non-small cell lung cancer, uterine tumors, glioblastoma, and sarcoma. RenovoGem received Orphan Drug Designation for pancreatic cancer and bile duct cancer which provides 7 years of market exclusivity upon New Drug Application (“NDA”) approval.

Current wording

We believe our noveland patented approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy. Our Phase III lead product candidate, RenovoGem, a novel oncology drug-device combination product, is being investigated under a U.S. new drug application that is regulated by the Food and Drug Administration’s (“FDA”) 21 CFR 312 pathway. RenovoGem is currently being evaluated for the treatment of locally advanced pancreatic cancer (“LPAC”) by the Center for Drug Evaluation and Research (the drug division of FDA). RenovoGem utilizes RenovoCath, our FDA-cleared drug-delivery device, indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion, in combination with gemcitabine (chemotherapy).

Previous wording

We have completed our RR1 Phase I/II and RR2 observational registry studies, with 20 and 25 patients respectively, in LAPC. These studies demonstrated a median Overall Survival (“OS”) of 27.9 months in LAPC patients pre-treated with radiation followed by treatment with RenovoGem. Based on previous large randomized clinical trials, the expected survival of LAPC patients is 12 to 15 months in patients receiving only IV systemic chemotherapy or IV chemotherapy plus radiation (which are both considered standard of care). Unlike the randomized trials that established these standard of care results, our RR1 and RR2 clinical trials did not prospectively control the standard of care therapy received prior to administration of RenovoGem. Based on an FDA safety review of our Phase I/II study, the FDA allowed us to proceed to evaluate RenovoGem within our Phase III registrational clinical trial.

Current wording

We have completed our RR1 Phase I/II and RR2 observational registry studies for RenovoGem, with 20 and 25 patients respectively, in LAPC. In the 35 pooled patients evaluable in these two studies, 9 patients pretreated with radiation followed by treatment with RenovoGem experienced a median Overall Survival (“OS”) of 27.1 months. Based on previous large randomized clinical trials, the expected survival of LAPC patients is 12.0 to 18.8 months in patients receiving only IV systemic chemotherapy or IV chemotherapy plus radiation (which are both considered standard of care). Unlike the randomized trials that established these standard of care results, our RR1 and RR2 clinical trials did not prospectively control the standard of care therapy received prior to administration of RenovoGem. Based on FDA safety review of our Phase I/II study, the FDA allowed us to proceed to evaluate RenovoGem following radiation pretreatment within our Phase III registrational clinical trial.

Previous wording

Our Phase III clinical trial of RenovoGem for the treatment of LAPC is calledTIGeR-PaC. This trial is an ongoing randomized multi-center study using TAMP to evaluate RenovoGem. The study is evaluating trans-arterial delivery, a form of intra-arterial (“IA”) administration, of an FDA-approved chemotherapy, gemcitabine, to treat LAPC following stereotactic body radiation therapy (“SBRT”). The study is comparing treatment of an FDA-approved cancer drug, gemcitabine, with TAMP versus systemic IV administration of gemcitabine and nab-paclitaxel.

Current wording

Our Phase III clinical trial of RenovoGem for the treatment of LAPC is called TIGeR-PaC. This trial is an ongoing randomized multi-center study using TAMP to evaluate RenovoGem. The study is evaluating trans-arterial delivery, a form of intra-arterial (“IA”) administration, of an FDA-approved chemotherapy, gemcitabine, to treat LAPC following stereotactic body radiation therapy (“SBRT”). The study is comparing treatment of LAPC using RenovoGem versus systemic IV administration of gemcitabine and nab-paclitaxel.

Previous wording

The first interim analysis in the TIGeR-PaC study at the 26 th event of the specified events (deaths), was completed in March 2023, with the Data Monitoring Committee recommending a continuation of the study. The TIGeR-PaC study’s primary endpoint is a 6-month OS benefit with secondary endpoints including reduced side effects versus standard of care. The data was first presented at the 2023 American Association for Cancer Research Annual Meeting in April 2023 and then as a Late Breaker Oral Presentation with additional secondary endpoint data at the 2023 European Society of Medical Oncology World Congress on Gastrointestinal Cancer in June 2023. The second interim analysis for this study will be triggered by the 52 nd event, which is estimated to occur in late 2024. The second interim data read out would follow thereafter, with the timing for such read out depending on customary factors such as time needed for analysis.

Current wording

The first interim analysis in the TIGeR-PaC study at the 26 th event of the specified events (deaths), was completed in March 2023, with the Data Monitoring Committee recommending a continuation of the study. The TIGeR-PaC study’s primary endpoint is a 6-month OS benefit with secondary endpoints including reduced side effects versus standard of care. The data was first presented at the 2023 American Association for Cancer Research Annual Meeting in April 2023 and then as a Late Breaker Oral Presentation with additional secondary endpoint data at the 2023 European Society of Medical Oncology World Congress on Gastrointestinal Cancer in June 2023. The second interim analysis for this study will be triggered by the 52 nd event, which is estimated to occur in late 2024 or early 2025. The second interim data readout would follow thereafter, with the timing for such readout depending on customary factors such as time needed for analysis. We are also aiming to complete patient enrollment in the TIGeR-PaC study during 2025.

Previous wording

Our TAMP therapy platform is focused on optimizing drug concentration in solid tumors using approved small molecule chemotherapeutics. Our platform enables physicians to isolate segments of the vascular anatomy closest to tumors and force chemotherapy across the blood vessel wall to bathe these difficult-to-reach solid tumors in chemotherapy. Specifically, our patented approach allows physicians to combine, on the one hand, pre-treatment of the local blood vessels and tissue with standard-of-care radiation therapy to decrease chemotherapy washout and, on the other hand, local delivery via our patentedRenovoCath delivery system which utilizes pressure to force small molecule chemotherapy into the tumor tissue. We believe there are many advantages to our TAMP therapy platform, including:

Current wording

Our TAMP therapy platform is focused on optimizing drug concentration in solid tumors using approved small molecule chemotherapeutics. Our platform enables physicians to isolate segments of the vascular anatomy closest to tumors and force chemotherapy across the blood vessel wall to bathe these difficult-to-reach solid tumors in chemotherapy. Specifically, our patented approach enables physicians to pre-treat patients with standard-of-care radiation therapy and utilize our RenovoCath delivery system to use pressure to force chemotherapy across the arterial wall near the tumor site to bathe the target tumor.

Previous wording

In a further validation of our TAMP platform, in July 2023, we announced a collaboration with Imugene(ASX: IMU)to explore expansion of our TAMP product pipeline with Imugene’s CF33 oncolytic virus therapy for the treatment of difficult-to-access tumors. We are constantly in discussions regarding similar collaborations and potentially out-licenses of RenovoGem as we gear up for the NDA filing (assuming we meet our study endpoints) and commercialization of RenovoGem (if approved by FDA) as well as other collaborations with our TAMP platform.

Current wording

In a further validation of our TAMP platform, in July 2023, we announced a collaboration with Imugene(ASX: IMU)to explore expansion of our TAMP product pipeline with Imugene’s CF33 oncolytic virus therapy for the treatment of difficult-to-access tumors. We are continually in discussions regarding similar collaborations and potentially out-licenses of RenovoGem as we prepare for the NDA filing (assuming we meet our study endpoints) and commercialization of RenovoGem (if approved by FDA) as well as other collaborations with our TAMP platform.

Previous wording

Since our inception, we have devoted substantially all of our efforts to developing our cancer therapy platform and product candidates, raising capital and organizing and staffing our Company. As of December 31, 2023, we have received over $41.8 million in gross proceeds and have financed our operations primarily through issuance of convertible preferred stock, convertible notes, securities in our IPO, common stock purchase warrants, an RDO in April 2023 and a loan pursuant to the Paycheck Protection Program under the Coronavirus Aid, Relief and Economic Security Act (the “CARES Act”). After deducting underwriting discounts, commissions, placement fees, legal fees, and other professional expenses of $3.5 million, our net offering proceeds were $38.3 million.

Current wording

Since our inception, we have devoted substantially all of our efforts to developing our cancer therapy platform and product candidates, raising capital and organizing and staffing our company. In January and April 2024, we raised additional funding in two private placements, offering shares of common stock and warrants to purchase shares of common stock for aggregate gross proceeds of $17.2 million. As of June 30, 2024, we have received over $59.2 million in aggregate gross proceeds and have financed our operations primarily through issuance of convertible preferred stock and convertible notes prior to our initial public offering, and securities issued in our August 2021 initial public offering, a registered direct offering with a single institutional investor in April 2023 (the “RDO”), common stock purchase warrants, the aforementioned January and April 2024 private placements, and a loan pursuant to the Paycheck Protection Program under the Coronavirus Aid, Relief and Economic Security Act (the “CARES Act”). After deducting underwriting discounts, commissions, placement fees, legal fees, and other professional expenses of $5.8 million, our net offering proceeds to date are $53.4 million.

Previous wording

We have incurred significant operating losses and generated negative cash flows from operations since our inception. As of March 31, 2024, we had cash and cash equivalents of $4.4 million. As of March 31, 2024, we had an accumulated deficit of $42.5 million. We expect to continue to incur significant expenses, increasing operating losses and negative cash flows for the foreseeable future. We do not expect to generate revenues from product sales unless and until we successfully complete development and obtain regulatory approval for one or more product candidates or engage in other activities that generate revenue sooner (including collaborations, licensing arrangements or other strategic or commercial activities relating to our technology). Given economic and market conditions and timing of regulatory approval, we expect that our expenses will increase in connection with our ongoing research and development activities, particularly if and when we decide to:

Current wording

We have incurred significant operating losses and generated negative cash flows from operations since our inception. As of June 30, 2024, we had cash and cash equivalents of $11.7 million. As of June 30, 2024, we had an accumulated deficit of $44.9 million. We expect to continue to incur significant expenses, increasing operating losses and negative cash flows for the foreseeable future. We do not expect to generate revenues from product sales unless and until we successfully complete development and obtain regulatory approval for one or more product candidates or engage in other activities that generate revenue sooner (including collaborations, licensing arrangements or other strategic or commercial activities relating to our technology). Given economic and market conditions and timing of regulatory approval, we expect that our expenses will increase in connection with our ongoing research, development and potential commercialization activities, particularly if and when we decide to:

Previous wording

We have not generated any revenue from product sales and do not currently expect to generate any revenue for the foreseeable future, if at all. If our development efforts for our current or future product candidates are successful and result in marketing approval or collaboration or license agreements with third parties, we may generate revenue in the future from a combination of product sales or payments from collaboration or license agreements. We may also pursue a strategy of commercializing our proprietary catheter delivery device, called RenovoCath, as a standalone device as a means of generating revenue.

Current wording

Currently, we have not generated any revenue from product sales of our patented RenovoCath device or as a result of our TIGeR-PaC clinical study or any other clinical or sales efforts. If our development efforts for our current or future product candidates are successful and result in marketing approval or collaboration or license agreements with third parties, we may generate revenue in the future from a combination of product sales or payments from collaboration or license agreements. We may also pursue a strategy of commercializing our RenovoCath, as a standalone device as a means of generating revenue.

Previous wording

Change in fair value of warrant liability represents the gain or loss reported from the change in the fair value of the warrant liability associated with the April 2023 Warrant. The fair value per share of the April 2023 Warrant was $0.99 and $1.69 on March 31, 2024 and December 31, 2023, respectively. The decrease in the fair value was primarily due to the decrease in our stock price.

Current wording

Change in fair value of warrant liability represents the gain or loss reported from the change in the fair value of the warrant liability associated with the April 2023 Warrant. The fair value per share of the April 2023 Warrant was $0.73 and $1.69 on June 30, 2024 and December 31, 2023, respectively. The decrease in the fair value was primarily due to the decrease in our stock price.

Previous wording

On March 27, 2020, the CARES Act was enacted. The CARES Act includes several significant provisions for corporations, including the usage of net operating losses, interest deductions and payroll benefits. Corporate taxpayers may carryback net operating losses, or NOLs, originating during 2018 through 2020 for up to five years.

Current wording

On March 27, 2020, the CARES Act was enacted. The CARES Act includes several significant provisions for corporations, including the usage of net operating losses (“NOLs”), interest deductions and payroll benefits. Corporate taxpayers may carryback NOLs originating during 2018 through 2020 for up to five years.

Previous wording

Research and development expenses were $1.3 million for the three months ended March 31, 2024, remaining flat compared to the same period last year. Higher clinical costs due to our ongoing Phase III clinical trial cost of $0.1 million, and an increase in employee and related benefits costs of $0.1 million, partially offset by a decrease in costs associated with clinical and regulatory consulting of $0.1 million. Allocated general and administrative support costs for personnel, facility and office supply expenses decreased by $0.1 million compared to the same period last year. We anticipate research and development expenses to increase as we increase manufacturing costs for our device and continue advancing our lead programs throughout the year.

Current wording

Research and development expenses were $1.5 million for the three months ended June 30, 2024, a decrease of $0.4 million compared to $1.9 million in the same period last year. This decrease was primarily due to lower clinical, regulatory and clinical consulting costs due to our ongoing Phase III clinical trial cost of $0.5 million as we reduced expenses to conserve our cash runway in the first quarter including a decrease in clinical conferences and trade shows of $0.1 million. The decrease was partially offset by an increase in employee and related benefits costs of $0.1 million and manufacturing for our proprietary catheter delivery device of $0.1 million. We anticipate research and development expenses to increase as we increase manufacturing costs for our device and continue advancing our TIGeR-PaC clinical study throughout the year.

Previous wording

General and administrative expenses were $1.2 million for the three months ended March 31, 2024, a decrease of $0.7 million compared to $1.9 million in the same period last year. This decrease was primarily due to lower costs in employee and related benefits costs due to decreased headcount of $0.1 million, legal, professional and consulting fees of $0.2 million, investor and public relations of $0.3 million, directors’ and officers’ liability insurance expense of $0.1 million, were partially offset by in lower allocated general and administrative costs of $0.1 million compared to the same period last year. We anticipate general and administrative expenses to increase somewhat throughout the year as we progress with our lead program.

Current wording

General and administrative expenses were $2.7 million for the six months ended June 30, 2024, a decrease of $0.7 million compared to $3.4 million for the prior year period. This decrease was primarily due to a reduction in professional and consulting fees of $0.2 million, recruitment fees of $0.1 million, investor and public relations costs of $0.2 million, directors’ and officers’ liability insurance expense of $0.1 million and legal fees of $0.1 million. This decrease was partially offset by lower allocated general and administration expenses to research and development of $0.1 million. We anticipate general and administrative expenses to increase somewhat throughout the year as we progress our TIGeR-PaC clinical study and as we explore potential commercialization activities for our RenovoCath device.

Previous wording

Other income/(expense), net was $1.4 million for the three months ended March 31, 2024, compared to nil in the same prior period. The increase was primarily due to a $1.4 million change in the fair value of the common warrant liability due to a decrease in our common stock price during the period.

Current wording

Other income/(expense), net was $2.0 million for the six months ended June 30, 2024, an increase of $1.0 million compared to $1.1 million for the prior year period. The increase was primarily due to a $0.3 million change in the fair value of the common warrant liability due to a decrease in our common stock price during the period, including an increase in interest and dividend income of $0.1 million due to the increase in cash and cash equivalents from the completion of two private placement financings completed earlier in the year. This increase was offset by $0.6 million of transaction costs allocated to common warrant liability.

Previous wording

For the three months ended March 31, 2024, we incurred a net loss of $1.1 million. As of March 31, 2024, our accumulated deficit stood at $42.5 million. We anticipate incurring further losses and increasing operating expenses in future periods.

Current wording

For the six months ended June 30, 2024, we incurred a net loss of $3.5 million. As of June 30, 2024, our accumulated deficit stood at $44.9 million. We anticipate incurring further losses and increasing operating expenses in future periods.

Previous wording

On January 26, 2024, we completed a private placement to 92 accredited investors with gross proceeds of $6.1 million. The private placement included issuing 6,133,414 shares of our common stock and common stock warrants to purchase 6,133,414 million shares of common stock which expire five years from the date of issuance. In connection with the private placement, we entered into a placement agent agreement, as additional compensation to the placement agent, and issued common stock warrants to purchase 511,940 shares of common stock which expire five years from the issuance date.

Current wording

On January 26, 2024, we completed a private placement to 92 accredited investors with gross proceeds of $6.1 million. The private placement included issuing 6,133,414 shares of our common stock and common stock warrants to purchase 6,133,414 shares of common stock, which expire five years from the date of issuance. In connection with the private placement, we entered into a placement agent agreement as additional compensation to the placement agent, and issued common stock warrants to purchase 511,940 shares of common stock, which expire five years from the issuance date.

Previous wording

As of March 31, 2024, we have received over $48.0 million in gross proceeds through various financial arrangements to include the issuance of preferred stock, convertible debt, securities in our IPO, the RDO, private placements and various loans. After deducting underwriting discounts, commissions, placement fees, legal fees, and other professional expenses of $4.9 million, our net offering proceeds from these activities were $43.1 million.

Current wording

As of June 30, 2024, we have received over $59.2 million in gross proceeds through various financial arrangements to include the issuance of preferred stock, convertible debt, securities in our IPO, the RDO, private placements and various loans. After deducting underwriting discounts, commissions, placement fees, legal fees, and other professional expenses of $5.8 million, our net offering proceeds from these activities were $53.4 million.

Previous wording

Based upon our current operating plan, management believes that its existing cash and cash equivalents as of March 31, 2024, will be sufficient to allow us to fund operating, investing and financing cash flow needs for at least twelve months from the date of issuance of these unaudited condensed interim financial statements. Given our financing activities subsequent to March 31, 2024 (see “Note 10. Subsequent Events” in Notes to the Unaudited Condensed Interim Financial Statements), as of the date of this Report we believe that we have sufficient cash resources to allow us to fund our operating, investing and financing cash flow needs at least through 12 months. The accompanying unaudited condensed interim financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The accompanying unaudited condensed interim financial statements do not reflect any adjustments relating to the recoverability and reclassification of assets and liabilities that might be necessary if the Company is unable to continue as a going concern.

Current wording

Based upon our current operating plan, management believes that its existing cash and cash equivalents as of June 30, 2024, will be sufficient to allow us to fund operating, investing and financing cash flow needs for at least twelve months from the date of issuance of these unaudited condensed interim financial statements. As of the date of this Report, we believe that we have sufficient cash resources to allow us to fund our operating, investing and financing cash flow needs at least through 12 months. The accompanying unaudited condensed interim financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The accompanying unaudited condensed interim financial statements do not reflect any adjustments relating to the recoverability and reclassification of assets and liabilities that might be necessary if the Company is unable to continue as a going concern.

Previous wording

Since our inception, we have not generated any revenue from product sales and we have incurred significant operating losses and negative cash flows from operations. We anticipate that we will continue to incur net losses for the foreseeable future. We do not have any products that have achieved regulatory marketing approval and we do not expect to generate revenue from sales of any product candidates for several years, if ever.

Current wording

Since our inception, we have not generated any revenue from product sales and we have incurred significant operating losses and negative cash flows from operations. We anticipate that we will continue to incur net losses for the foreseeable future. We do not have any drug-device combination products that have achieved regulatory marketing approval and we do not expect to generate revenue from sales of any drug-device combination product candidates for several years, if ever. While we are actively, in parallel to our clinical efforts, exploring commercialization of our FDA-cleared RenovoCath delivery system on a standalone basis, which could generate revenues over the nearer term, our plans in this regard may not lead to meaningful revenue generation or cash liquidity for us over the next 12 months, if at all.

Previous wording

We have financed our operations through the date of this Report primarily through the issuance and sale of convertible preferred stock and convertible debt. Through the date of this report, we have raised an aggregate of $59.2 million from private placements of our convertible preferred stock, convertible debt securities, the issuance of securities in our IPO, RDO and other private placement offerings, various loans and the exercise of warrants and common stock options. During the first four months of 2024 alone, we raise new capital for aggregate gross proceeds of $17.2 million, which provides us with a cash runway at least through 12 months.

Current wording

We have financed our operations from inception through the date of this Report primarily through the issuance and sale of an aggregate of $59.2 million from private placements of our convertible preferred stock, convertible debt securities prior to our August 2021 initial public offering, and the issuance of securities in our initial public offering, our RDO and other private placement offerings, various loans and the exercise of warrants and common stock options. During the first four months of 2024 alone, we raise new capital for aggregate gross proceeds of $17.2 million, which provides us with a cash runway at least through 12 months from the date of this Report.

Previous wording

Cash used in operating activities for the three months ended March 31, 2024, reflected a net loss of $1.1 million, offset by non-cash charges of $0.9 million, and net change in our operating assets and liabilities of $0.2 million.

Current wording

Cash used in operating activities for the six months ended June 30, 2024, reflected a net loss of $3.5 million and non-cash charges of $1.2 million, and offset by net change in our operating assets and liabilities of $0.2 million.

Previous wording

Cash used in operating activities for the three months ended March 31, 2023, reflected a net loss of $3.3 million, offset by non-cash charges of $0.4 million, consisting of stock-based compensation expense and a net change in our operating assets and liabilities of $0.2 million.

Current wording

Cash used in operating activities for the six months ended June 30, 2023, reflected a net loss of $5.6 million and non-cash charges of $1.0 million, offset by a net change in our operating assets and liabilities of $1.1 million.

Previous wording

Cash provided by investing activities for the three months ended March 31, 2023, consisted of U.S. Treasury bills held to maturity.

Current wording

Cash provided by investing activities for the six months ended June 30, 2023, consisted of U.S. Treasury bills held to maturity.

Previous wording

Net cash provided by financing activities for the three months ended March 31, 2024 was $5.4 million, consisting primarily of net proceeds from private placement offering.

Current wording

Net cash provided by financing activities for the six months ended June 30, 2024 was $15.1 million, consisting primarily of net proceeds from private placement offering.

Previous wording

Net cash provided by financing activities for the three months ended March 31, 2023 was $6,000, consisting of proceeds from the exercise of stock options.

Current wording

Net cash provided by financing activities for the six months ended June 30, 2023 was $5.0 million, consisted primarily of proceeds from common stock and pre-funded common warrants.

Previous wording

The accompanying management’s discussion and analysis of our financial condition and results of operations are based upon our unaudited condensed interim financial statements and the related disclosures, which have been prepared in accordance with U.S. GAAP. The preparation of these unaudited condensed interim financial statements requires us to make estimates, assumptions and judgments that affect the reported amounts in our unaudited condensed interim financial statements and accompanying notes. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. To the extent that there are material differences between these estimates and actual results, our future financial statement presentation, financial condition, results of operations and cash flows will be affected. Our critical accounting policies and estimates are detailed in our 2023 Annual Report.

Current wording

The accompanying management’s discussion and analysis of our financial condition and results of operations are based upon our unaudited condensed interim financial statements and the related disclosures, which have been prepared in accordance with GAAP. The preparation of these unaudited condensed interim financial statements requires us to make estimates, assumptions and judgments that affect the reported amounts in our unaudited condensed interim financial statements and accompanying notes. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. To the extent that there are material differences between these estimates and actual results, our future financial statement presentation, financial condition, results of operations and cash flows will be affected. Our critical accounting policies and estimates are detailed in our 2023 Annual Report.

Previous wording

There have been no significant changes to our critical accounting policies or significant judgments and estimates for the three months ended March 31, 2024, from those previously disclosed in our 2023 Annual Report.

Current wording

There have been no significant changes to our critical accounting policies or significant judgments and estimates for the six months ended June 30, 2024, from those previously disclosed in our 2023 Annual Report.

Previous wording

Direct offering costs consist principally of commissions, placement fees and other expenses, including other professional expenses incurred. We evaluate the terms under the financing agreement to determine the classification of direct costs in the accompanying Condensed Statements of Operations.

Current wording

Direct offering costs consist principally of commissions, placement fees and legal fees, including other professional expenses incurred. We evaluate the terms under the financing agreement to determine the classification of direct costs in the accompanying Condensed Statements of Operations.