RenovoRx Inc

Previous wording

Unless the context otherwise requires, all references in this section to the “Company,” “we,” “us,” or “our” refer to RenovoRx, Inc. You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our unaudited interim condensed financial statements and related notes included elsewhere in this Report, our management’s discussion and analysis of financial condition and results of operations for the year ended December 31, 2023, included in our 2023 Annual Report and our final prospectus, dated August 25, 2021, filed with the SEC pursuant to Rule 424(b)(4) under the Securities Act.

Current wording

Unless the context otherwise requires, all references in this section to the “Company,” “we,” “us,” or “our” refer to RenovoRx, Inc. You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our unaudited interim condensed financial statements and related notes included elsewhere in this Report, our management’s discussion and analysis of financial condition and results of operations for the year ended December 31, 2023, which is included in our 2023 Annual Report.

Previous wording

This discussion contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act that reflect our plans, estimates, and beliefs that involve risks and uncertainties, including those described in the section titled “Cautionary Note Regarding Forward Looking Statements.” Our actual results and the timing of selected events could differ materially from those discussed below. Factors that could cause or contribute to such differences include, but are not limited to, those identified below and those set forth under the section titled “Risk Factors” included elsewhere in this Report and in the 2023 Annual Report.

Current wording

This discussion contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act that reflect our plans, estimates, and beliefs that involve risks and uncertainties, including those described in the section of this Report titled “Cautionary Note Regarding Forward Looking Statements.” Our actual results and the timing of selected events could differ materially from those discussed below. Factors that could cause or contribute to such differences include, but are not limited to, those identified below and those set forth under the section titled “Risk Factors” included elsewhere in this Report and in the 2023 Annual Report.

Previous 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).

Current wording

Our lead product candidate is a novel oncology drug-device combination product and is being investigated under a U.S. Investigational New Drug (“IND”) application that is regulated by the FDA’s 21 CFR 312 pathway. The investigational drug-device combination candidate utilizes RenovoCath®, our FDA-cleared device, indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion.

Previous wording

We may also evaluate RenovoGem as a potential therapy in other indications. 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 by the FDA. As described further below under “Other Potential Opportunities for RenovoCath,” we are also actively exploring ways to further develop and utilize our drug-delivery device.

Current wording

We may also evaluate RenovoCath with gemcitabine as a potential therapy in other indications. RenovoCath with gemcitabine received Orphan Drug Designation for pancreatic cancer and bile duct cancer, which provides 7 years of market exclusivity upon NDA approval by the FDA.

Previous 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.

Current wording

We have completed our RR1 Phase I/I and RR2 observational registry studies for RenovoCath with gemcitabine, 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 RenovoCath with gemcitabine 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 RenovoCath with gemcitabine. Based on FDA safety review of our Phase I/II study, the FDA allowed us to proceed to evaluate RenovoCath with gemcitabine within our Phase III TIGeR-PaC clinical trial.

Previous 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.

Current wording

Ourongoing Phase III TIGeR-PaC clinical trial, a randomized, multi-center study, is evaluating RenovoRx’s first product candidate, using TAMP, a novel investigational oncology drug-device combination utilizing the Company’s FDA-cleared RenovoCath device for the intra-arterial administration of gemcitabineto treat LAPC following stereotactic body radiation therapy (“SBRT”). The study compares the treatment of LAPC using RenovoCath with gemcitabine versus systemic IV administration of gemcitabine and nab-paclitaxel.

Previous wording

Our protocol for TIGeR-PaC involves systemic chemotherapy and only SBRT during the induction phase of the study (prior to randomization). Patients receiving SBRT during the induction phase are required to complete 5 treatments, over 5 consecutive days, and do not receive oral chemotherapy vs. previously utilized intensity-modulated radiation therapy (“IMRT”) where patients must complete 25 radiation treatments in combination with oral chemotherapy during the induction phase of the study, which takes between 35 and 56 days to complete. In December 2021, we amended our protocol and statistical analysis plan for TIGeR-PaC (the “Modified SAP”) to (i) analyze only patients receiving SBRT during the induction phase, (ii) include a second interim analysis, (iii) change the total number of patients randomized in the study to 114 with a total of 86 deaths from SBRT patients, and (iv) repower the study from 90% to 80%, which is commonly used in clinical trials. We believe this design will shorten the timeframe needed to complete the study and also significantly decrease our costs. We have not discussed the protocol amendment or the Modified SAP with the FDA, and we cannot provide any assurance that the FDA will agree with these modifications, but these modifications have been submitted to the FDA.

Current wording

Our protocol for TIGeR-PaC involves systemic chemotherapy and SBRT during the induction phase of the study (prior to randomization). Patients receiving SBRT during the induction phase are required to complete 5 treatments, over 5 consecutive days, and do not receive oral chemotherapy vs. previously utilized intensity-modulated radiation therapy (“IMRT”) where patients must complete 25 radiation treatments in combination with oral chemotherapy during the induction phase of the study, which takes between 35 and 56 days to complete. In December 2021, we amended our protocol and statistical analysis plan for TIGeR-PaC (the “Modified SAP”) to (i) enroll and analyze only patients receiving SBRT during the induction phase, (ii) include a second interim analysis, (iii) change the total number of patients randomized in the study to 114 with a total of 86 deaths from SBRT patients, and (iv) repower the study from 90% to 80%,The change to the 80% power calculation aligns with common practice for clinical trials and, we believe this design will shorten the timeframe needed to complete the study, as well as significantly decrease our costs. We have not discussed the protocol amendment or the Modified SAP with the FDA, and we cannot provide any assurance that the FDA will agree with these modifications, but these modifications have been submitted to the FDA.

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 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.

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 an OS benefit with secondary endpoints including reduced side effects versus standard of care. 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 in the first half of 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 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.

Current wording

Our patented TAMP therapy platform is focused on optimizing drug concentration in solid tumors by delivering oncology therapies with our RenovoCath delivery system. TAMP is designed to enable physicians to isolate segments of the vascular anatomy closest to tumors and ensure precise therapeutic delivery, while potentially minimizing a therapy’s toxicities versus systemic intravenous therapy. 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 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.

Current wording

In a further validation of our TAMP platform, last year, 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 RenovoCath with gemcitabine as we prepare for the NDA filing (assuming we meet our study endpoints) and commercialization of RenovoCath (if approved by FDA) as well as other collaborations with our TAMP platform.

Previous wording

In recent years, we have focused our efforts primarily on progressing RenovoGem through our ongoing Phase III TIGeR-PaC study for LAPC. During this process, we have begun to explore other opportunities for our TAMP therapy platform, including an additional potential Phase II/III trial (called the CouGAr trial), which would evaluate RenovoGem in a second indication, bile duct cancer.

Current wording

In recent years, we have focused our efforts primarily on progressing RenovoCath with gemcitabine through our ongoing Phase III TIGeR-PaC study for LAPC. During this process, we have begun to explore other opportunities for our TAMP therapy platform.

Previous wording

As a result of the introduction of our FDA-cleared RenovoCath delivery system as part of the TIGeR-PaC study and the resulting unsolicited, and subsequently solicited, feedback we have received from physicians and key opinion leaders in the oncology space, during the first half of 2024, we began to actively explore a new opportunity to market and sell RenovoCath as a standalone device. RenovoCath is indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. Based on physician interest, we could consider engaging in this potentially revenue-generating activity either on our own or, more likely, in tandem with a commercial partner. This business development opportunity would also likely lead us to engage in Phase IV post-market “registry” clinical studies of the RenovoCath device to gather additional data to support both our clinical and commercial efforts.

Current wording

As a result of the introduction of our FDA-cleared RenovoCath delivery system as part of the TIGeR-PaC study and the resulting unsolicited (and subsequently solicited) feedback we have received from oncologists, surgeons, and interventional radiologists indicating increased demand for targeted delivery of diagnostic and/or therapeutic agents, during the first half of 2024, we began to actively explore a new opportunity to market and sell RenovoCath as a standalone device. RenovoCath is FDA-cleared and indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. We will engage in this potential revenue-generating activity either on our own or, more likely, in tandem with a commercial partner.

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. 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.

Current wording

Since our inception, we have devoted substantially all 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 September 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 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:

Current wording

We have incurred significant operating losses and generated negative cash flows from operations since our inception. As of September 30, 2024, we had cash and cash equivalents of $9.6 million. As of September 30, 2024, we had an accumulated deficit of $47.3 million. We expect to continue to incur significant expenses, increasing operating losses and negative cash flows for the foreseeable future. At the time we launch our commercial strategy, we anticipate to generate revenue from RenovoCath device sales via either on our own or, more likely, in tandem with a commercial partner our direct channel and/or collaborations, licensing arrangements or other strategic or commercial activities. Given economic and market conditions and the 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

In addition to the variables described above, if and when any of our product candidates successfully complete development, we will incur substantial additional costs associated with establishing a sales, marketing, medical affairs and distribution infrastructure to commercialize our products for which we may obtain marketing approval, regulatory filings, marketing approval, and post-marketing requirements, in addition to other commercial costs. We cannot reasonably estimate these costs at this time.

Current wording

As a result, we will require significant additional funding to support our continuing operations. If and when any of our product candidates successfully complete development, we will incur substantial additional costs associated with establishing a sales, marketing, medical affairs and distribution infrastructure to commercialize our products for which we may obtain marketing approval, regulatory filings, marketing approval, and post-marketing requirements, in addition to other commercial costs. We cannot reasonably estimate these costs at this time.

Previous wording

Interest expense consists of expense for the amortization of Directors and Officers liability insurance premiums.

Current wording

Interest expense consists of financing interest for the Directors and Officers liability insurance premiums.

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 $0.73 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.

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 $0.61 and $1.69 on September 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

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.

Current wording

Research and development expenses were approximately $1.7 million for the three months ended September 30, 2024, remaining relatively flat compared to the same period last year. Employee and related benefit costs increased $0.1 million including an increase of $0.1 million in clinical conferences and trade shows activities. This increase was partially offset by lower regulatory and clinical consulting costs and manufacturing for our proprietary catheter delivery device. We anticipate research and development expenses to increase as we increase manufacturing costs for our device and continue advancing our Phase III clinical trial study throughout the remainder of the year.

Previous wording

General and administrative expenses were $1.5 million for the three months ended June 30, 2024, remaining flat compared to the same period last year. Employee and related benefits costs increased by $0.1 million, including investor and public relations costs of $0.1 million. This increase was partially offset by a decrease in professional and consulting fees of $0.1 million and recruitment fees of $0.1 million. We anticipate general and administrative expenses to increase moderately throughout the year as we progress our TIGeR-PaC clinical study and as we explore potential commercialization activities for our RenovoCath device.

Current wording

General and administrative expenses were approximately $1.2 million for the three months ended September 30, 2024, a decrease of approximately $0.2 million compared to approximately $1.4 million for the same period last year. The decrease was primarily due to decreases of $0.2 million in professional and consulting fees, and legal fees, partially offset by an increase of $0.1 million in investor and public relations costs. We anticipate general and administrative expenses increasing moderately throughout the remaining year as we progress our commercialization activities for our RenovoCath device.

Previous wording

Other income/(expense), net was $0.6 million for the three months ended June 30, 2024, a decrease of $0.4 million compared to $1.0 million in the same period last year. The decrease was primarily due to a $1.1 million change in the fair value of the common warrant liability offset by transaction costs allocated to warrant liabilities of $0.6 million.

Current wording

Other income/(expense), net was approximately $0.4 million for the three months ended September 30, 2024, a decrease of approximately $1.2 million compared to approximately $1.6 million for the in the same period last year. The decrease was primarily due to a $1.3 million change in the fair value of the common warrant liability offset by interest and dividend income of $0.1 million.

Previous wording

Comparison of the Six Months Ended June 30, 2024, and 2023

Current wording

Comparison of the Nine Months Ended September 30, 2024, and 2023

Previous wording

Research and development expenses totaled $2.8 million for the six months ended June 30, 2024, a decrease of $0.5 million, compared to $3.3 million for the prior year period. 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 $0.2 million and manufacturing for our proprietary catheter delivery device of $0.1 million. We expect the secondary manufacturer device company to commence production later this year. 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 progress our TIGeR-PaC clinical study throughout the year.

Current wording

Research and development expenses were approximately $4.4 million for the nine months ended September 30, 2024, a decrease of approximately $0.5 million, compared to approximately $4.9 million for the prior year period. The decrease was primarily due lower costs of $0.6 million on clinical, regulatory and clinical consulting costs from our ongoing Phase III clinical trial cost as we reduced expenses to conserve our cash runway in the first quarter and a decrease of $0.1 million in clinical conferences and trade shows, partially offset by an increase of $0.3 million in employee and related benefits costs. Our primary manufacturer company of our RenovoCath device commenced production this year as we implemented our commercialization and sale of our product candidate’s strategy. 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 progress our commercialization strategy, including our ongoing Phase III clinical trial study throughout the remainder of the year.

Previous 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.

Current wording

General and administrative expenses were approximately $3.9 million for the nine months ended September 30, 2024, a decrease of approximately $0.8 million compared to approximately $4.7 million for the prior year period. The decrease was primarily due to a $0.3 million reduction in professional and consulting fees, a $0.1 million decrease in recruitment fees, a $0.2 million decrease in investor and public relations costs, a $0.2 million decrease in directors’ and officers’ liability insurance expense and a $0.1 million decrease in legal fees. The 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 slightly throughout the remaining year as we progress with our commercialization activities for our RenovoCath device.

Previous 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.

Current wording

Other income/(expense), net was approximately $2.4 million for the nine months ended September 30, 2024, a decrease of approximately $0.2 million compared to approximately $2.6 million for the prior year period. The decrease was primarily due to a $1.0 million change in the fair value of the common warrant liability due to a decline in our common stock price during the nine months ended September 30, 2023 as compared to September 30, 2024. The decrease was offset by a $0.2 million increase in interest and dividend income from an increase in cash and cash equivalents related to the completion of two private placement financings completed earlier in the year and $0.6 million of transaction costs allocated to common warrant liability in the previous period.

Previous 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.

Current wording

For the nine months ended September 30, 2024, we incurred a net loss of $5.9 million. As of September 30, 2024, our accumulated deficit stood at $47.3 million. We anticipate incurring further losses and increasing operating expenses in future periods.

Previous wording

On April 11, 2024, we completed a second private placement offering, issuing common stock, pre-funded warrants, Series A warrants, and Series B warrants. The aggregate gross proceeds from this offer were $11.1 million, and the net offering proceeds were $9.7 million after deducting placement agent fees of $1.2 million and other professional expenses of $0.2 million. In conjunction with the issuance of 6,960,864 shares of common stock, we bundled the offering with: (i) a pre-funded warrant exercisable for 951,500 shares of common stock at an exercise price of $0.0001 per share, with an unlimited term and immediate exercisability upon issuance, subject to specific beneficial ownership limitations; (ii) Series A warrants exercisable or 7,912,364 shares of common stock at $1.22 per share, valid for 5 years and immediately exercisable subject to customary adjustments and beneficial ownership limitations; (iii) Series B warrants exercisable for 3,956,182 shares of common stock at $1.22 per share, valid for 2 years and immediately exercisable subject to customary adjustments and beneficial ownership limitations, with us retaining the right to call these warrants under certain conditions. Additionally, we issued the April 2024 PA Warrants on the same date, exercisable for 701,243 shares of common stock at $1.69 per share over a 5-year term, with provisions for cashless exercise if the shares are unregistered or no current prospectus is available for resale. The April 2024 PA Warrants become exercisable on October 11, 2024, subject to specific beneficial ownership limitations and customary adjustments.

Current wording

On April 11, 2024, we completed a second private placement offering, issuing common stock, pre-funded warrants, Series A warrants, and Series B warrants. The aggregate gross proceeds from this offer were $11.1 million, and the net offering proceeds were $9.7 million after deducting placement agent fees of $1.2 million and other professional expenses of $0.2 million. In conjunction with the issuance of 6,960,864 shares of common stock, we bundled the offering with: (i) a pre-funded warrant exercisable for 951,500 shares of common stock at an exercise price of $0.0001 per share, with an unlimited term and immediate exercisability upon issuance, subject to specific beneficial ownership limitations; (ii) Series A warrants exercisable for 7,912,364 shares of common stock at $1.22 per share, valid for 5 years and immediately exercisable subject to customary adjustments and beneficial ownership limitations; (iii) Series B warrants exercisable for 3,956,182 shares of common stock at $1.22 per share, valid for 2 years and immediately exercisable subject to customary adjustments and beneficial ownership limitations, with us retaining the right to call these warrants under certain conditions. Additionally, we issued the April 2024 PA Warrants on the same date, exercisable for 701,243 shares of common stock at $1.69 per share over a 5-year term, with provisions for cashless exercise if the shares are unregistered or no current prospectus is available for resale. The April 2024 PA Warrants become exercisable on October 11, 2024, subject to specific beneficial ownership limitations and customary adjustments.

Previous wording

We believe we will continue to be able to raise additional capital through debt financing, private or public equity financings, license agreements, obtain a credit facility or other loan or at-the-market offering, collaborative agreements or other arrangements with other companies, or other sources of financing. Our ability to obtain additional required financing will be subject to a number of factors, including market conditions, fluctuations in interest rates, our operating performance and investor sentiment. However, there can be no assurances that such financing will be available or will be at terms acceptable to us, or at all. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our clinical trials, discontinue the development and/or commercialization of our product candidates, restrict or cease our operations or obtain funds by entering into agreements on unfavorable terms. If any of these events occur, our ability to achieve our operational goals would be adversely affected. Our future capital requirements and the adequacy of available funds will depend on many factors, including those described in the section titled “Risk Factors in Part I item 1A on Form 10-K on our 2023 Annual Report.” Depending on the severity and direct impact of these factors on us, we may be unable to secure additional financing to meet our operating requirements on commercially acceptable terms favorable to us, or at all.

Current wording

Our ability to obtain additional required financing will be subject to a number of factors, including market conditions, fluctuations in interest rates, our operating performance and investor sentiment. However, there can be no assurances that such financing will be available or will be at terms acceptable to us, or at all. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our clinical trials, discontinue the development and/or commercialization of our product candidates, restrict or cease our operations or obtain funds by entering into agreements on unfavorable terms. If any of these events occur, our ability to achieve our operational goals would be adversely affected. Our future capital requirements and the adequacy of available funds will depend on many factors, including those described in the section titled “Risk Factors in Part I item 1A on Form 10-K on our 2023 Annual Report.” Depending on the severity and direct impact of these factors on us, we may be unable to secure additional financing to meet our operating requirements on commercially acceptable terms favorable to us, or at all.

Previous 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.

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. After deducting underwriting discounts and commissions, placement agent fees and other offering expenses, net offerings were $53.8 million. During the first four months of 2024 alone, we raised new capital for aggregate gross proceeds of $17.2 million, to further advance our programs.

Previous 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.

Current wording

Cash used in operating activities for the nine months ended September 30, 2024, reflected a net loss of $5.9 million and non-cash charges of $1.2 million, and offset by net change in our operating assets and liabilities of $0.4 million.

Previous 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.

Current wording

Cash used in operating activities for the nine months ended September 30, 2023, reflected a net loss of $7.0 million and non-cash charges of $2.2 million, offset by a net change in our operating assets and liabilities of $1.0 million.

Previous wording

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

Current wording

Cash provided by investing activities for the nine months ended September 30, 2023, consisted of $2.0 million from the sale of investments.

Previous 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.

Current wording

Net cash provided by financing activities for the nine months ended September 30, 2024 was $15.1 million, consisting primarily of net proceeds from two private placement offerings.

Previous 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.

Current wording

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

Previous 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.

Current wording

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

Previous wording

We evaluate pre-funded warrant and April 2023 Warrant issued in connection with registered direct financing in April 2023 to determine where such warrants qualify for equity classification, or meet the definition of a derivative instrument, classified as a liability on the condensed balance sheets and measured at fair value at inception and at each reporting date with changes in fair value recognized in the Condensed Statements of Operations in the period of change.

Current wording

We evaluate pre-funded warrants and April 2023 Warrant issued in connection with registered direct financing in April 2023 to determine whether such warrants qualify for equity classification, or meet the definition of a derivative instrument, classified as a liability on the Condensed Balance Sheets and measured at fair value at inception and at each reporting date with changes in fair value recognized in the Condensed Statements of Operations in the period of change.

Previous wording

We are an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, as amended, or the JOBS Act. Under the JOBS Act, companies have extended transition periods available for complying with new or revised accounting standards. We have elected this exemption to delay adopting new or revised accounting standards. We will remain an emerging growth company until the earlier of (1) December 31, 2026, (2) the last day of the fiscal year in which we have total annual gross revenues of at least $1.07 billion, (3) the date on which we are deemed to be a “large accelerated filer” as defined in Rule 12b-2 under the Exchange Act, or (4) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period. An emerging growth company may take advantage of specified reduced reporting requirements and is relieved of certain other significant requirements that are otherwise generally applicable to public companies. As an emerging growth company,

Current wording

We are an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, as amended, or the JOBS Act. Under the JOBS Act, companies have extended transition periods available for complying with new or revised accounting standards. We have elected this exemption to delay adopting new or revised accounting standards. We will remain an emerging growth company until the earlier of (1) December 31, 2026, (2) the last day of the fiscal year in which we have total annual gross revenues of at least $1.235 billion, (3) the date on which we are deemed to be a “large accelerated filer” as defined in Rule 12b-2 under the Exchange Act, or (4) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period. An emerging growth company may take advantage of specified reduced reporting requirements and is relieved of certain other significant requirements that are otherwise generally applicable to public companies. As an emerging growth company,

Previous wording

We are also a “smaller reporting company,” meaning that the market value of our stock held by non-affiliates plus the proposed aggregate amount of gross proceeds to us as a result of this offering is less than $700.0 million and our annual revenue is less than $100.0 million during the most recently completed fiscal year. We may continue to be a smaller reporting company if either (1) the market value of our stock held by nonaffiliates is less than $250.0 million or (2) our annual revenue is less than $100.0 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700.0 million. If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, like emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.

Current wording

We are also a “smaller reporting company,” meaning that the market value of our stock held by non-affiliates plus the proposed aggregate amount of gross proceeds to us is less than $700.0 million and our annual revenue is less than $100.0 million during the most recently completed fiscal year. We may continue to be a smaller reporting company if either (1) the market value of our stock held by nonaffiliates is less than $250.0 million or (2) our annual revenue is less than $100.0 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700.0 million. If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, like emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.