CalciMedica Inc

Previous wording

Our lead product candidate is Auxora, a potent and selective intravenous formulated small molecule CRAC channel inhibitor containing the active compound zegocractin (formerly referred to as CM4620) that, in animal models, reduced acute epithelial and/or endothelial cell injury and inflammation in organs, such as the pancreas, lungs and kidneys. Multiple Phase 2 clinical trials with Auxora have been conducted: an open-label trial in acute pancreatitis (“AP”), a placebo-controlled double-blinded trial in AP (which we refer to as “CARPO”), an investigator led open label trial in asparaginase pancreatic toxicity (“AIPT”) (which we also refer to as “CRSPA”) in which the first cohort of patients has been completed, a placebo-controlled double-blind trial in severe COVID-19 pneumonia (which we also refer to as “CARDEA”) and an investigator led open-label trial in COVID-19 pneumonia patients with acute respiratory distress syndrome (“ARDS”). We observed in all of these trials that patients treated with Auxora experienced a reduced time to recovery and a reduction of organ damage. We believe the consistency of the results we observed from these trials in two different acute critical care conditions are mutually supportive and reinforce our plans to further pursue the use of Auxora in several additional acute critical illnesses.

Current wording

Our lead product candidate is Auxora, a potent and selective intravenous formulated small molecule CRAC channel inhibitor containing the active compound zegocractin (formerly referred to as CM4620) that, in animal models, reduced acute epithelial and/or endothelial cell injury and inflammation in organs, such as the pancreas, lungs and kidneys. Multiple Phase 2 clinical trials with Auxora have been conducted: an open-label Phase 2a trial in acute pancreatitis (“AP”) with accompanying systematic inflammatory response syndrome (“SIRS”), an international, randomized, double-blind placebo-controlled Phase 2b trial in AP with SIRS (which we refer to as “CARPO”), an investigator led open-label Phase 1/2 trial in asparaginase-induced pancreatic toxicity (“AIPT”) (which we also refer to as “CRSPA”) in which the first cohort of patients has been completed, a placebo-controlled double-blind Phase 2 trial in severe COVID-19 pneumonia (which we also refer to as “CARDEA”) and an investigator led open-label Phase 2a trial in COVID-19 pneumonia patients with acute respiratory distress syndrome (“ARDS”). We observed in all of these trials that patients treated with Auxora experienced a reduced time to recovery and a reduction of organ damage. We believe the consistency of the results we observed from these trials in two different acute critical care conditions are mutually supportive and reinforce our plans to further pursue the use of Auxora in several additional acute critical illnesses, including acute kidney injury (“AKI”) with associated acute hypoxemic respiratory failure (“AHRF”) where we are currently conducting a Phase 2 trial (which we also refer to as “KOURAGE”).

Previous wording

In a Phase 2a trial conducted in the United States in patients with AP and accompanying systemic inflammatory response syndrome (“SIRS”) along with hypoxemia (low concentration of oxygen in blood), a greater proportion of patients treated with Auxora compared to standard of care (“SOC”) alone experienced reduced incidence of persistent SIRS (SIRS lasting 48 hours or more) and tolerated solid food at 72 hours, an indicator of disease resolution. The majority of patients with respiratory failure treated with Auxora did not require mechanical ventilation. This resulted in hospital discharge for patients treated with Auxora more than two days earlier than those treated with SOC alone. These findings were published in the peer-reviewed journal Pancreas in 2021. In June 2024, we announced topline data from an international, randomized, double-blind placebo-controlled Phase 2b trial in patients with AP and accompanying SIRS (which we also refer to as “CARPO”). The trial met its primary objective with statistically significant dose response in median time to solid food tolerance in a prespecified subgroup of patients with hyper-inflamed AP, as well as showed a statistically significant dose response in reduction of severe organ failure across the full patient population. Full data from the trial will be available in the second half of 2024, and we plan to present it at medical meetings. Further, we plan to discuss the full results with the FDA in an end-of-phase 2 meeting once they become available and to be in a position to initiate a pivotal trial in AP in 2025.

Current wording

In October 2024, in a plenary session at the American College of Gastroenterology annual meeting, we presented late-breaking data and previously announced data from CARPO. The trial met its primary objective with statistically significant dose response in median time to solid food tolerance in a prespecified subgroup of patients with hyper-inflamed AP, as well as showed a statistically significant dose response in reduction of severe organ failure across the full patient population. Auxora also reduced new onset severe respiratory failure by 100% (p=0.0027) in the combined medium and high dose patient population when compared to the combined placebo and low dose patient population and reduced new onset persistent respiratory failure by 64.2% (p=0.0476) when comparing these same patient groups. There were approximately 20% fewer patients in the high dose group who developed necrotizing pancreatitis compared to placebo patients and these high dose patients also had median time to medically indicated discharge of 15 hours less than placebo patients. Finally, a stratified win-ratio analysis of key endpoints gave a stratified 1.640 win-ratio benefit (p=0.0372) for the high dose patients compared to placebo patients. We plan to discuss the full results with the FDA in an end-of-Phase 2 meeting and to be in a position to initiate a Phase 3 program in AP in 2025. In a prior Phase 2a trial conducted in the United States in patients with AP and accompanying SIRS along with hypoxemia (low concentration of oxygen in blood), a greater proportion of patients treated with Auxora compared to standard of care (“SOC”) alone experienced reduced incidence of persistent SIRS (SIRS lasting 48 hours or more) and tolerated solid food at 72 hours, an indicator of disease resolution. The majority of patients with respiratory failure treated with Auxora did not require mechanical ventilation. This resulted in hospital discharge for patients treated with Auxora more than two days earlier than those treated with SOC alone. These findings were published in the peer-reviewed journal Pancreas in 2021.

Previous wording

CRSPA, a Phase 1/2 single arm 24-patient trial, is currently being conducted in the United States in pediatric patients with acute lymphoblastic leukemia (“ALL”) who have developed pancreatitis as a side-effect of asparaginase or AIPT. CRSPA is an investigator-sponsored trial being conducted by St. Jude Children’s Research Hospital (“SJCRH”). AIPT is a particularly severe form of pancreatitis and historical data suggests that over half of the patients will develop pancreatic necrosis or pseudocysts and may not receive further asparaginase treatments for their ALL, potentially impacting their prognosis, and can develop long term health complications including chronic pancreatitis. The first cohort of nine patients in this trial has been completed, and the results were presented at the American Society of Hematology (“ASH”) meeting in December 2023. Eight of nine patients in the CRSPA study received a full regimen of four daily doses of Auxora and these patients were compared to a matched historical control group of patients who developed AIPT within 30 days of receiving asparaginase in the Total Therapy XVI study (T16) being conducted at SJCRH. Treatment with Auxora, as compared to the matched historical control group, was shown to have the potential to reduce the severity of AIPT in pediatric patients with ALL. Study results showed that Auxora reduced the average number of days patients spent in the hospital and the need for care in the intensive care unit (“ICU”). Additionally, no patients in the CRSPA study required total parenteral nutrition (“TPN”), compared to over half the patients in the matched historical control group, who required nearly four weeks of nutritional support on average. Finally, blinded central reading of pancreatic imaging showed a reduction in the development of significant pancreatic necrosis and the severity of acute pancreatitis in patients treated with Auxora compared to the matched historical control group. This trial has expanded to additional sites and we expect data in 2025.

Current wording

CRSPA, a Phase 1/2 single arm 24-patient trial, is currently being conducted in the United States in pediatric patients with acute lymphoblastic leukemia (“ALL”) who have developed pancreatitis as a side-effect of one of the elements of standard of care, asparaginase, referred to as AIPT. CRSPA is an investigator-sponsored trial being conducted by St. Jude Children’s Research Hospital (“SJCRH”). AIPT is a particularly severe form of pancreatitis and historical data suggests that over 50% of patients will develop pancreatic necrosis or pseudocysts and may not receive further asparaginase treatments for their ALL, potentially impacting their prognosis, and can develop long term health complications including chronic pancreatitis. The first cohort of nine patients in this trial has been completed, and the results were presented at the American Society of Hematology (“ASH”) meeting in December 2023. Eight of nine patients in the CRSPA study received a full regimen of four daily doses of Auxora and these patients were compared to a matched historical control group of patients who developed AIPT within 30 days of receiving asparaginase in the Total Therapy XVI study (T16) being conducted at SJCRH. Treatment with Auxora, as compared to the matched historical control group, was shown to have the potential to reduce the severity of AIPT in pediatric patients with ALL. Study results showed that Auxora reduced the average number of days patients spent in the hospital and the need for care in the intensive care unit (“ICU”). Additionally, no patients in the CRSPA study required total parenteral nutrition (“TPN”), compared to over half the patients in the matched historical control group, who required nearly four weeks of nutritional support on average. Finally, blinded central reading of pancreatic imaging showed a reduction in the development of significant pancreatic necrosis and the severity of acute pancreatitis in patients treated with Auxora compared to the matched historical control group. This trial has expanded to additional sites and we expect data in 2025.

Previous wording

In addition to AP and AIPT, we are conducting a Phase 2 randomized double-blind, placebo-controlled trial in patients with severe acute kidney injury (“AKI”) that also have acute hypoxemic respiratory failure (“AHRF”), which we call KOURAGE. KOURAGE will evaluate 150 patients with stage 2 and stage 3 AKI who have AHRF and are receiving oxygen either by non-invasive mechanical ventilation, high flow nasal cannula or intermittent mandatory ventilation (“IMV”). Patients will be stratified by classification of stage of AKI as well as the use of IMV. Patients will receive either a four-hour infusion of Auxora or placebo at 1.25 mL/kg as a first dose, after which they will receive Auxora or placebo at 1.0 mL/kg at hours 24, 48, 72 and 96. The primary endpoint of the trial will be evaluation of patients through day 30 to determine days alive, ventilator-free and dialysis-free. Secondary endpoints will include a composite of all-cause mortality, decrease in estimated glomerular filtration rate (“eGFR”), and the incidence of dialysis over a period of 90 days, also known as MAKE-90 (Major Adverse Kidney Events at 90 days). In February 2024, we received clearance from the FDA of our Investigational New Drug Application (“IND”) for KOURAGE, the Phase 2 clinical trial of Auxora for the treatment of AKI patients with AHRF. In July 2024, we announced that we have begun enrolling patients in KOURAGE and expect to report results from this trial in 2025.

Current wording

In addition to AP and AIPT, we are conducting KOURAGE, a Phase 2 randomized double-blind, placebo-controlled trial in patients with severe acute kidney injury AKI that also have acute hypoxemic respiratory failure (“AHRF”), which we call KOURAGE. KOURAGE will evaluate 150 patients with stage 2 and stage 3 AKI who have AHRF and are receiving oxygen either by non-invasive mechanical ventilation, high flow nasal cannula or invasion mechanical ventilation (“IMV”). Patients will be stratified by classification of stage of AKI as well as the use of IMV. Patients will receive either a four-hour infusion of Auxora or placebo at 1.25 mL/kg as a first dose, after which they will receive Auxora or placebo at 1.0 mL/kg at hours 24, 48, 72 and 96. The primary endpoint of the trial will be evaluation of patients through day 30 to determine days alive, ventilator-free and dialysis-free. Secondary endpoints will include a composite of all-cause mortality, decrease in estimated glomerular filtration rate (“eGFR”), and the incidence of dialysis over a period of 90 days, also known as MAKE-90 (Major Adverse Kidney Events at 90 days). In February 2024, we received clearance from the FDA of our Investigational New Drug Application (“IND”) for KOURAGE, the Phase 2 clinical trial of Auxora for the treatment of AKI patients with AHRF. In July 2024, we announced that we have begun enrolling patients in KOURAGE and expect to report results in 2025.

Previous wording

Our ability to generate revenue from product sales sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our product candidates. Through June 30, 2024, our operations have been funded primarily by aggregate net proceeds of $169.7 million from the issuance of convertible preferred stock, convertible notes, common stock and the Merger. Since inception we have had significant operating losses, except for the three month period ending March 31, 2024. Our net loss was $3.8 million for the six months ended June 30, 2024. Included in the net loss for the six months ended June 30, 2024 were total operating expenses of $12.3 million, offset by a gain from the fair value adjustment to our warrant liability of $7.9 million and interest income of $0.6 million. As of June 30, 2024, we had an accumulated deficit of $149.9 million and $19.1 million in cash, cash equivalents and short-term investments.

Current wording

Our ability to generate revenue from product sales sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our product candidates. Through September 30, 2024, our operations have been funded primarily by aggregate net proceeds of $169.7 million from the issuance of convertible preferred stock, convertible notes, common stock and the Merger. Since inception we have had significant operating losses, except for the three month period ending March 31, 2024. Our net loss was $9.4 million for the nine months ended September 30, 2024. Included in the net loss for the nine months ended September 30, 2024 were total operating expenses of $18.0 million, offset by a gain from the fair value adjustment to our warrant liability of $7.8 million and interest income of $0.8 million. As of September 30, 2024, we had an accumulated deficit of $155.5 million and $14.6 million in cash, cash equivalents and short-term investments.

Previous wording

Research and development expenses were $4.1 million for the three months ended June 30, 2024, compared to $3.8 million for the three months ended June 30, 2023. The increase of $0.3 million was due primarily to an increase of $0.7 million in chemistry, manufacturing and control activities in regard to our Phase 2 clinical trials of Auxora and personnel costs of $0.1 million. This was partially offset by a decrease of $0.5 million in preclinical activities relating to Auxora and CM6336.

Current wording

Research and development expenses were $3.5 million for the three months ended September 30, 2024, compared to $2.8 million for the three months ended September 30, 2023. The increase of $0.7 million was due primarily to an increase of $0.5 million in preclinical activities relating to Auxora and CM6336, our oral compound and an increase in personnel, consultants and other costs of $0.2 million.

Previous wording

General and administrative expenses were $2.4 million for the three months ended June 30, 2024, compared to $2.8 million for the three months ended June 30, 2023. The decrease of $0.4 million was primarily related to a decrease in professional services of $0.4 million and consultants and other costs of $0.1 million. These costs were partially offset by an increase in personnel costs of $0.1 million.

Current wording

General and administrative expenses were $2.2 million for the three months ended September 30, 2024, compared to $2.1 million for the three months ended September 30, 2023. The increase of $0.1 million was primarily related an increase in personnel costs of $0.2 million, partially offset by a decrease in consultants and other costs of $0.1 million.

Previous wording

Other income for the three months ended June 30, 2024 was income of $2.6 million, compared to $0.3 million for the three months ended June 30, 2023. The increase of $2.3 million was due to the fair value adjustments to our warrant liability as a result of the 2024 Private Placement, which resulted in a gain of $2.3 million. We had $0.3 million of interest income on our cash equivalents and short-term investments for each of the three months ended June 30, 2024 and 2023.

Current wording

Other income for the three months ended September 30, 2024 was income of $0.1 million, compared to $0.2 million for the three months ended September 30, 2023. The decrease of $0.1 million was due to the fair value adjustments to our warrant liability as a result of the 2024 Private Placement in the first quarter of 2024, which resulted in a loss of $0.1 million. We had $0.2 million of interest income on our cash equivalents and short-term investments for each of the three months ended September 30, 2024 and 2023.

Previous wording

Research and development expenses were $7.1 million for the six months ended June 30, 2024, compared to $10.3 million for the six months ended June 30, 2023. The decrease of $3.2 million was due primarily to a one-time charge for the acceleration of vesting of stock options of $1.9 million and a one-time severance charge of $1.6 million as a result of the Merger for the six months ended June 30, 2023 and a decrease of $0.6 million in preclinical activities relating to Auxora and CM6336. This was partially offset by an increase of $0.9 million in chemistry, manufacturing and control activities in regard to our Phase 2 clinical trials of Auxora and consultants and other costs of $0.2 million.

Current wording

Research and development expenses were $10.6 million for the nine months ended September 30, 2024, compared to $13.1 million for the nine months ended September 30, 2023. The decrease of $2.4 million was due primarily to a decrease in personnel costs of $3.5 million including a one-time charge for the acceleration of vesting of stock options of $1.9 million and a one-time severance charge of $1.6 million as a result of the Merger for the nine months ended September 30, 2023. This was partially offset by an increase of $0.9 million in chemistry, manufacturing and control activities in regard to our Phase 2 clinical trials of Auxora and consultants and other costs of $0.2 million.

Previous wording

General and administrative expenses were $5.2 million for the six months ended June 30, 2024, compared to $18.6 million for the six months ended June 30, 2023. The decrease of $13.4 million was primarily related to a decrease in personnel costs of $13.8 million driven by a one-time charge for the acceleration of vesting of stock options of $8.6 million and a one-time severance charge of $4.1 million as a result of the Merger for the six months ended June 30, 2023. Additionally, professional services decreased $0.2 million as a result of the Merger for the six months ended June 30, 2024. These costs were partially offset by an increase of $0.6 million in consultants and other costs.

Current wording

General and administrative expenses were $7.4 million for the nine months ended September 30, 2024, compared to $20.7 million for the nine months ended September 30, 2023. The decrease of $13.3 million was primarily related to a decrease in personnel costs of $13.6 million driven by a one-time charge for the acceleration of vesting of stock options of $8.6 million and a one-time severance charge of $4.1 million as a result of the Merger for the nine months ended September 30, 2023. Additionally, professional services decreased $0.2 million as a result of not incurring costs associated with the Merger for the nine months ended September 30, 2024. These costs were partially offset by an increase of $0.5 million in consultants and other costs.

Previous wording

Other income for the six months ended June 30, 2024 was income of $8.5 million, compared to $3.3 million for the six months ended June 30, 2023. The increase of $5.2 million was due to the fair value adjustments to our warrant liability as a result of the 2024 Private Placement, which resulted in a gain of $7.9 million offset by the fair value adjustment to our warrant liability and convertible promissory notes, which resulted in a $3.2 million gain for the six months ended June 30, 2023. We had $0.6 million of interest income on our cash equivalents and short-term investments and $0.3 million for the six months ended June 30, 2024 and 2023, respectively. There was a decrease in interest expense of $0.1 million due to the conversion of the convertible notes in 2023.

Current wording

Other income for the nine months ended September 30, 2024 was income of $8.5 million, compared to $3.5 million for the nine months ended September 30, 2023. The increase of $5.0 million was due to the fair value adjustments to our warrant liability as a result of the 2024 Private Placement in the first quarter of 2024, which resulted in a gain of $7.8 million for the nine months ended September 30, 2024 compared to the fair value adjustments to our warrant liability and convertible promissory notes for the nine months ended September 30, 2023, which resulted in a $3.2 million gain. We had a decrease in accrued interest of $0.1 million on our convertible notes for the nine months ended September 30, 2023 as well as an increase of $0.3 million of interest income on our cash, cash equivalents and short-term investments for the nine months ended September 30, 2024.

Previous wording

As of June 30, 2024 we had cash, cash equivalents and short-term investments of $19.1 million.

Current wording

As of September 30, 2024 we had cash, cash equivalents and short-term investments of $14.6 million.

Previous wording

As further described below, we closed the 2024 Private Placement transaction on January 23, 2024, and the second closing occurred on February 5, 2024. Gross proceeds from the transaction were $20.4 million, with net proceeds of approximately $19.0 million after deducting $1.4 million in commissions and other transaction costs. Based on our current operating plans, we believe our cash, cash equivalents and short-term investments along with the net proceeds from the 2024 Private Placement will be sufficient to fund our operations into the second half of 2025. In particular, we expect that our cash, cash equivalents and short-term investments will allow us to fund the advancement of Auxora in AP, AIPT and AKI through clinical milestones in 2024 and the first half of 2025. However, our current cash, cash equivalents and short-term investments will not be sufficient to fund any of our product candidates through regulatory approval, nor will it be sufficient to pursue additional indications for Auxora like AHRF, nor will it be sufficient to fund clinical work on other product candidates in our portfolio aside from Auxora, and we will need to raise substantial additional capital to complete the development and commercialization of our product candidates.

Current wording

As further described below, on November 1, 2024, we closed the 2024 Follow-On of 2,720,000 shares of our common stock at a price to the public of $3.75 per share. The gross proceeds from the offering, before deducting underwriting discounts and commissions and offering expenses, were $10.2 million. In addition, we have granted the underwriters a 30-day option to purchase up to an additional 408,000 shares of our common stock at the public offering price, less underwriting discounts and commissions. Based on our current operating plans, we believe our cash, cash equivalents and short-term investments, including the proceeds from the 2024 Follow-On, will be sufficient to fund our current operations for the next twelve months from the date of this report. In particular, we expect that our cash, cash equivalents and short-term investments, including the proceeds from the 2024 Follow-On, will allow us to fund our operations through certain clinical milestones, into the first half of 2026. However, our current cash, cash equivalents and short-term investments will not be sufficient to fund any of our product candidates through regulatory approval, nor will it be sufficient to pursue additional indications for Auxora such as AHRF, nor will it be sufficient to fund clinical work on other product candidates in our portfolio aside from Auxora, and we will need to raise substantial additional capital to complete the development and commercialization of our product candidates.

Previous wording

In August 2023, we filed the Shelf Registration Statement, which contains two prospectuses, a base prospectus and an at the market offering prospectus that covers the offering, issuance and sale of up to $17.3 million of common stock pursuant to the ATM Agreement with H.C Wainwright & Co., LLC, acting as sales agent. The Shelf Registration Statement permits the offering, issuance and sale of common stock, preferred stock, debt securities and warrants having an aggregate offering price of up to $100.0 million in one or more offerings and in any combination of the foregoing. As of June 30, 2024, $99.6 million remains available for sale under the Shelf Registration Statement. During the three months ended June 30, 2024, 8,950 shares were sold under the ATM Facility for net proceeds of $51,000, after deducting $1,500 of commissions and $500 of settlement fees. As of June 30, 2024, we sold an aggregate of 101,522 shares of common stock for net proceeds of $312,000 after deducting $13,000 of commissions paid under the ATM Facility and approximately $17.0 million remains available for sale under the ATM Facility.

Current wording

In August 2023, we filed the Shelf Registration Statement, which contains two prospectuses, a base prospectus and an at the market offering prospectus that covers the offering, issuance and sale of up to $17.3 million of common stock pursuant to the ATM Agreement with Wainwright & Co., acting as sales agent. The Shelf Registration Statement permits the offering, issuance and sale of common stock, preferred stock, debt securities and warrants having an aggregate offering price of up to $100.0 million in one or more offerings and in any combination of the foregoing. As of September 30, 2024, $99.6 million remains available for sale under the Shelf Registration Statement. During the three months ended September 30, 2024, there were no shares were sold under the ATM Facility. As of September 30, 2024, we sold an aggregate of 101,522 shares of common stock for net proceeds of $319,000 after deducting $13,000 of commissions paid under the ATM Facility and approximately $17.0 million remains available for sale under the ATM Facility. On October 30, 2024, we suspended sales under the ATM Facility and will not make any sales thereunder until a new at-the-market offering prospectus supplement is filed with the SEC.

Previous wording

Our operations have been funded primarily by aggregate net proceeds of $169.7 million from the issuance of convertible preferred stock, convertible notes, common stock and the Merger. Since inception, we have had significant operating losses, except for the three month period ending March 31, 2024. Our net loss for the six months ended June 30, 2024 was $3.8 million and consisted of total operating expenses of $12.3 million offset by a gain from the fair value adjustment to our warrant liability of $7.9 million and interest income of $0.6 million. For the six months ended June 30, 2023, our net loss was $25.6 million consisting of $28.9 million of operating expenses (including $10.5 million in one-time charges related to the acceleration of vesting of the Graybug stock awards at the date of the Merger and $5.7 million of one-time severance charges as a result of the Merger). As of June 30, 2024, we had an accumulated deficit of $149.9 million and $19.1 million in cash, cash equivalents and short-term investments. During the six months ended June 30, 2024, cash used in operations was $11.5 million, primarily due to cash outlays for operations. Our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures, and to a lesser extent, general and administrative expenditures. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable and accrued expenses.

Current wording

Our operations through September 30, 2024, have been funded primarily by aggregate net proceeds of $169.7 million from the issuance of convertible preferred stock, convertible notes, common stock and the Merger. Since inception, we have had significant operating losses, except for the three month period ending March 31, 2024. Our net loss for the nine months ended September 30, 2024 was $9.4 million and consisted of total operating expenses of $18.0 million offset by a gain from the fair value adjustment to our warrant liability of $7.8 million and interest income of $0.8 million. For the nine months ended September 30, 2023, our net loss was $30.2 million consisting of $33.8 million of operating expenses (including $10.5 million in one-time charges related to the acceleration of vesting of the Graybug stock awards at the date of the Merger and $5.7 million of one-time severance charges as a result of the Merger). As of September 30, 2024, we had an accumulated deficit of $155.5 million and $14.6 million in cash, cash equivalents and short-term investments. During the nine months ended September 30, 2024, cash used in operations was $16.2 million, primarily due to cash outlays for operations. Our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures, and to a lesser extent, general and administrative expenditures. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable and accrued expenses.

Previous wording

Cash used in operating activities of $11.5 million during the six months ended June 30, 2024 was attributable to our net income of $3.8 million, non-cash items of $6.6 million and a net change in our operating assets and liabilities of $1.1 million. Non-cash items consisted primarily of $7.9 million due to a change in our warrant liability as result of the 2024 Private Placement in the first quarter of 2024 and accretion on our short term investments of $0.4 million, offset by $0.8 million of transaction costs allocated to warrants and $0.9 million of stock-based compensation.

Current wording

Cash used in operating activities of $16.2 million during the nine months ended September 30, 2024 was attributable to our net loss of $9.4 million, non-cash items of $5.8 million and a net change in our operating assets and liabilities of $1.0 million. Non-cash items consisted primarily of $7.8 million due to a change in our warrant liability as result of the 2024 Private Placement in the first quarter of 2024 and accretion on our short term investments of $0.5 million, offset by $0.8 million of transaction costs allocated to warrants and $1.7 million of stock-based compensation.

Previous wording

Cash used in operating activities of $17.5 million during the six months ended June 30, 2023 was attributable to our net loss of $25.6 million and a net change of $0.4 million in our operating assets and liabilities offset by non-cash items of $8.5 million. Non-cash items includes $10.5 million in one-time charges related to the acceleration of vesting of the Graybug stock awards at the date of the Merger, $1.1 million of stock-based compensation and $0.1 million in accrued interest on our convertible promissory notes, offset by $1.2 million and $2.0 million change in the fair value of our warrant liability and convertible promissory notes, respectively based on the value the warrant holder and promissory note holder received in common stock.

Current wording

Cash used in operating activities of $22.1 million during the nine months ended September 30, 2023 was attributable to our net loss of $30.2 million offset by non-cash items of $9.0 million and a net change in our operating assets and liabilities of $0.9 million. Non-cash items consisted primarily of $12.1 million of stock-based compensation, which includes $10.5 million in one-time charges related to the acceleration of vesting of the Graybug stock awards at the date of the Merger and $0.1 million in accrued interest on our convertible promissory notes, offset by $1.2 million and $2.0 million change in the fair value of our warrant liability and convertible promissory notes, respectively, based on the value the warrant holder and promissory note holder received in common stock.

Previous wording

Net Cash Provided by (Used in) Investing Activities

Current wording

Net Cash Provided by Investing Activities

Previous wording

Cash used in investing activities of $8.0 million for the six months ended June 30, 2024 consisted of the purchase of short-term investments of $17.9 million, offset by maturing of short-term investments of $9.9 million.

Current wording

Cash provided by investing activities of $0.8 million for the nine months ended September 30, 2024 consisted of the purchase of short-term investments of $18.8 million, offset by the maturing of short-term investments of $19.6 million.

Previous wording

Cash provided by investing activities of $14.5 million for the six months ended June 30, 2023 consisted of maturities of short-term investments of $14.6 million, offset by purchases of property and equipment of $0.1 million.

Current wording

Cash provided by investing activities of $11.6 million for the nine months ended September 30, 2023 consisted of the maturing of short-term investments of $14.6 million, offset by the purchase of short-term investments of $2.9 and purchases of property and equipment of $0.1 million.

Previous wording

Cash provided by financing activities for the six months ended June 30, 2024 was $19.1 million comprised of the sale and issuance of common stock of $20.4 million in the 2024 Private Placement and $0.1 million as a result of our ATM Facility, offset by transaction costs of $1.4 million.

Current wording

Cash provided by financing activities for the nine months ended September 30, 2024 was $19.1 million comprised of the sale and issuance of common stock of $20.4 million in the 2024 Private Placement and $0.1 million as a result of our ATM Facility and exercise of stock options, offset by transaction costs of $1.4 million.

Previous wording

Cash provided by financing activities for the six months ended June 30, 2023 was $20.7 million and comprised of cash acquired as a result of the Merger of $14.9 million, the sale and issuance of common stock of $10.3 million in the 2023 Private Placement, offset by transaction costs of $4.5 million.

Current wording

Cash provided by financing activities for the nine months ended September 30, 2023 was $20.7 million and comprised of cash acquired as a result of the Merger of $14.9 million, the sale and issuance of common stock of $10.3 million in the 2023 Private Placement, and $0.1 million in the ATM Facility, offset by transaction costs of $4.6 million.

Previous wording

Our material cash requirements from known contractual obligations consisted primarily of our lease obligation. We lease office and laboratory space in La Jolla, California with monthly rent expense of approximately $10,000 pursuant to a 12 month lease agreement that commenced in January 2023 and was amended and renewed in December 2023 for an additional 12 month term with monthly rent expense of approximately $10,000. Over the next six months, we expect cash requirements for our lease obligation to be approximately $60,000.

Current wording

Our material cash requirements from known contractual obligations consisted primarily of our lease obligation. We lease office and laboratory space in La Jolla, California with monthly rent expense of approximately $10,000 pursuant to a 12 month lease agreement that commenced in January 2023 and was amended and renewed in December 2023 for an additional 12 month term with monthly rent expense of approximately $10,000. Over the next three months, we expect cash requirements for our lease obligation to be approximately $30,000.