ARS Pharmaceuticals Inc

Previous wording

We believe neffy’s “no needle, no injection” approach will address a significant unmet need in the use of epinephrine, which is currently approved only in injectable formulations for the emergency treatment of Type I allergic reactions. There are approximately 40 million people in the United States who experience Type I allergic reactions. Of this group, approximately 20 million people have been diagnosed and experienced severe Type I allergic reactions that may lead to anaphylaxis, but only 3.2 million currently have an active epinephrine autoinjector prescription, and of those, only half consistently carry their prescribed autoinjector with them due to the many drawbacks of these devices. In aggregate, we estimate that 90% of patients prescribed an epinephrine device are not achieving an optimal treatment outcome today. These drawbacks include the use of needles in the devices, which can result in patient and caregiver injury as well as hesitation and delays in administration due principally to apprehension and pain of needles, allowing the allergic reaction to progress in severity leading to symptoms that seriously impact patient quality of life, to potential need for emergency services and/or hospitalizations, and to life-threatening symptoms or events. Intra-muscular injections also are subject to dosing errors and risk of accidental blood vessel injections, which can cause a significant spike in the intravascular delivery of epinephrine potentially leading to serious cardiovascular complications or events. We believe neffy’s “no needle, no injection” delivery that eliminates apprehension, pain and safety concerns, small size allowing for ease of portability, ease of use, and high reliability provide it with a user-friendly profile that will increase prescriptions for epinephrine and make it more likely for patients and caregivers to administer epinephrine sooner, achieve more rapid symptom relief and prevent the allergic reaction from progressing to a level of severity that could lead to hospitalization or even death.

Current wording

We believe neffy’s “no needle, no injection” approach will address a significant unmet need in the use of epinephrine, which is currently approved only in injectable formulations for the emergency treatment of Type I allergic reactions. There are approximately 40 million people in the United States who experience Type I allergic reactions. Of this group, over the last three years, approximately 20 million people have been diagnosed and experienced severe Type I allergic reactions that may lead to anaphylaxis, but (in 2023, for example) only 3.2 million filled their active epinephrine autoinjector prescription, and of those, only half consistently carry their prescribed autoinjector with them due to the many drawbacks of these devices. In aggregate, we estimate that up to 90% of patients prescribed an epinephrine device are not achieving an optimal treatment outcome today. These drawbacks include the use of needles in the devices, which can result in patient and caregiver injury as well as hesitation and delays in administration due principally to apprehension and pain of needles, allowing the allergic reaction to progress in severity leading to symptoms that seriously impact patient quality of life, to potential need for emergency services and/or hospitalizations, and to life-threatening symptoms or events. Intra-muscular injections also are subject to dosing errors and risk of accidental blood vessel injections, which can cause a significant spike in the intravascular delivery of epinephrine potentially leading to serious cardiovascular complications or events. We believe neffy’s “no needle, no injection” delivery that eliminates apprehension, pain and safety concerns, small size allowing for ease of portability, ease of use, and high reliability provide it with a user-friendly profile that will increase prescriptions for epinephrine and make it more likely for patients and caregivers to administer epinephrine sooner, achieve more rapid symptom relief and prevent the allergic reaction from progressing to a level of severity that could lead to hospitalization or even death.

Previous wording

Following the acceptance of our NDA in October 2022 for review by the FDA, on May 11, 2023, the FDA held a virtual meeting of its Pulmonary-Allergy Drugs Advisory Committee (“PADAC”). At that meeting, on the question of whether the data from ourneffy pharmacokinetic (“PK”)/pharmacodynamic (“PD”) results support a favorable benefit-risk assessment in adults for the emergency treatment of Type I allergic reactions including anaphylaxis, the PADAC voted 16 (yes) and 6 (no). On the question of whether theneffy PK/PD results support a favorable benefit-risk assessment in children ≥30 kg for the emergency treatment of Type I allergic reactions including anaphylaxis, the PADAC voted 17 (yes) and 5 (no). Although the FDA considers the recommendations of the PADAC, the recommendation by the PADAC is non-binding.

Current wording

Following the acceptance of our NDA in October 2022 for review by the U.S. Food and Drug Administration (“FDA”), on May 11, 2023, the FDA held a virtual meeting of its Pulmonary-Allergy Drugs Advisory Committee (“PADAC”). At that meeting, on the question of whether the data from ourneffy pharmacokinetic (“PK”)/pharmacodynamic (“PD”) results support a favorable benefit-risk assessment in adults for the emergency treatment of Type I allergic reactions including anaphylaxis, the PADAC voted 16 (yes) and 6 (no). On the question of whether theneffy PK/PD results support a favorable benefit-risk assessment in children ≥30 kg for the emergency treatment of Type I allergic reactions including anaphylaxis, the PADAC voted 17 (yes) and 5 (no). Although the FDA considers the recommendations of the PADAC, the recommendation by the PADAC is non-binding.

Previous wording

We reported topline data in February 2024 from this additional repeat dose study requested by the FDA, and submitted our response to the FDA’s CRL in April 2024, with an anticipated PDUFA target action date of October 2, 2024. We have also completed the additional nitrosamine testing based on the new draft guidance issued by the FDA in August 2023, and no measurable levels of nitrosamines were detected. If approved, we believe neffy will be the first “no needle, no injection” marketed epinephrine product for the emergency treatment of type I allergic reactions.

Current wording

We reported topline data in February 2024 from this additional repeat dose study requested by the FDA, and submitted our response to the FDA’s CRL in April 2024, with a PDUFA target action date of October 2, 2024 assigned by the FDA. The FDA acknowledged receipt of the submission and considered it a complete response to the September 19, 2023 action letter with no comments. We have also completed the additional nitrosamine testing based on the new draft guidance issued by the FDA in August 2023, and no measurable levels of nitrosamines were detected. If approved, we believe neffy will be the first “no needle, no injection” marketed epinephrine product for the emergency treatment of type I allergic reactions.

Previous wording

Our marketing authorization application (“MAA”) forneffyis also under review by the European Medicines Agency (“EMA”). In April 2024, we submitted a response to the CHMP for our MAA forneffy. A decision from the CHMP is expected in the second quarter of 2024.

Current wording

Our marketing authorization application (“MAA”) forneffyis also under review by the European Medicines Agency (“EMA”). In April 2024, we submitted a response to the Committee for Medicinal Products for Human Use (“CHMP”) for our MAA forneffy. In June 2024, the CHMP adopted a positive opinion for EURneffy (the tradename forneffy in the European Union (“EU”)), recommending the granting of a market authorization in the EU for the emergency treatment of allergic reactions (anaphylaxis). The EMA decision is normally issued 67 days from the adoption of the CHMP opinion, and, if favorable, is followed by a grant of marketing authorization by the European Commission.

Previous wording

We reported positive topline results demonstrating statistically significant and clinically meaningful improvements in treatment-refractory chronic urticaria patients at the American Academy of Allergy and Immunology medical conference in February 2024, and anticipate initiating a Phase 2 clinical trial in the outpatient urticaria setting in the second half of 2024, followed by the potential initiation of a single pivotal efficacy study in 2025.

Current wording

We reported positive topline results demonstrating statistically significant and clinically meaningful improvements in treatment-refractory chronic urticaria patients at the American Academy of Allergy and Immunology medical conference in February 2024, and anticipate initiating a Phase 2 clinical trial in the outpatient urticaria setting in the fourth quarter of 2024, followed by the potential initiation of a single pivotal efficacy study in 2025.

Previous wording

Since our inception in 2015 as ARS Pharmaceuticals, Inc., we have devoted substantially all of our efforts and financial resources to organizing and staffing our company, business planning, raising capital, performing research and development activities, pre-commercial activities, and providing general and administrative support for these operations. We do not have any products approved for sale and have not generated any product sales. We have funded our operations primarily with proceeds from the Merger (as more fully described below), private placement of convertible preferred stock, licensing, supply and distribution arrangements with our commercialization partners, and bank debt. From inception to March 31, 2024, we have raised $262.3 million in cash, cash equivalents and short-term investments, net of transaction costs, from the Merger; net proceeds of $76.3 million from the issuance of convertible preferred and common stock; $27.8 million from our collaboration, licensing, supply and distribution arrangements; and $10.0 million from bank debt. As of March 31, 2024, we had cash, cash equivalents, and short-term investments of $223.6 million.

Current wording

Since our inception in 2015 as ARS Pharmaceuticals, Inc., we have devoted substantially all of our efforts and financial resources to organizing and staffing our company, business planning, raising capital, performing research and development activities, pre-commercial activities, and providing general and administrative support for these operations. We do not have any products approved for sale and have not generated any product sales. We have funded our operations primarily with proceeds from the Merger (as more fully described below), private placement of convertible preferred stock, licensing, supply and distribution arrangements with our commercialization partners, and bank debt. From inception to June 30, 2024, we have raised $262.3 million in cash, cash equivalents and short-term investments, net of transaction costs, from the Merger; net proceeds of $76.3 million from the issuance of convertible preferred and common stock; $28.5 million from our collaboration, licensing, supply and distribution arrangements; and $10.0 million from bank debt. As of June 30, 2024, we had cash, cash equivalents, and short-term investments of $218.7 million.

Previous wording

We have incurred net losses from operations since our inception. Our net losses were $10.3 million and $15.0 million for the three months ended March 31, 2024 and 2023, respectively. As of March 31, 2024 we had an accumulated deficit of $141.6 million. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials, our expenditures on other development activities, the cost for regulatory filings, expenses for pre-commercial activities to establish sales, marketing and distribution capabilities for our product candidates, and our ability to earn potential regulatory and commercial milestones under our collaboration arrangements. We expect our expenses and operating losses will increase substantially as our product candidate, neffy potentially is approved by the FDA and we commence commercialization efforts, any future product candidates advance through clinical trials, and we expand our clinical, regulatory, quality, manufacturing and pre-commercial sales and marketing capabilities. If we obtain marketing approval for any of our product candidates, we will incur significant commercialization expenses for marketing, sales, manufacturing and distribution activities, and added expenditures to expand our operational, financial and management systems and increase personnel to support these operations.

Current wording

We have incurred net losses from operations since our inception. Our net losses were $22.8 million and $32.3 million for the six months ended June 30, 2024 and 2023, respectively. As of June 30, 2024 we had an accumulated deficit of $154.1 million. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials, our expenditures on other development activities, the cost for regulatory filings, expenses for pre-commercial activities to establish sales, marketing and distribution capabilities for our product candidates, and our ability to earn potential regulatory and commercial milestones under our collaboration arrangements. We expect our expenses and operating losses will increase substantially if our product candidate, neffy, is approved by the FDA and we commence commercialization efforts, we advance neffyfor additional indications, any future product candidates advance through clinical trials, and we expand our clinical, regulatory, quality, manufacturing and pre-commercial sales and marketing capabilities. If we obtain marketing approval forneffyor any of future product candidate, we will incur significant commercialization expenses for marketing, sales, manufacturing and distribution activities, and added expenditures to expand our operational, financial and management systems and increase personnel to support these operations.

Previous wording

On February 22, 2023, we entered into the Termination Agreement with Recordati, pursuant to which, among other things, we and Recordati agreed to terminate the Recordati License and Supply Agreement. Pursuant to the Termination Agreement, we reacquired all of the Recordati Rights, paid Recordati a one-time upfront payment of €3.0 million, and have agreed to pay additional payments upon achievement of certain milestones including: (i) an EMA regulatory milestone payment of €2.0 million, (ii) a milestone payment of €5.0 million upon first commercial sale of a Recordati Licensed Product in the Recordati Territory, and (iii) royalty payments of up to €5.0 million in the aggregate from sales of Recordati Licensed Product(s) in the Recordati Territory.

Current wording

On February 22, 2023, we entered into a termination agreement (the “Recordati Termination Agreement”) with Recordati, pursuant to which, among other things, we and Recordati agreed to terminate the Recordati License and Supply Agreement. Pursuant to the Recordati Termination Agreement, we reacquired all of the Recordati Rights, paid Recordati a one-time upfront payment of €3.0 million, and have agreed to pay additional payments upon achievement of certain milestones including: (i) an EMA regulatory milestone payment of €2.0 million, (ii) a milestone payment of €5.0 million upon first commercial sale of a Recordati Licensed Product in the Recordati Territory, and (iii) royalty payments of up to €5.0 million in the aggregate from sales of Recordati Licensed Product(s) in the Recordati Territory. As of June 30, 2024, the EMA regulatory milestone was met and a €2.0 million ($2.1 million in U.S. dollars) expense was recorded in research and development expense in the accompanying condensed consolidated statements of operations and comprehensive loss and the corresponding liability was recorded in accounts payable and accrued liabilities in the accompanying condensed consolidated balance sheet.

Previous wording

We expect our research and development expenses to decrease in 2024 compared to 2023 based on our planned clinical development and manufacturing activities, as we plan to transition to commercialization efforts for the potential launch of our first product in the second half of 2024. However, the timing for regulatory approvals is outside our control, may be delayed and is uncertain. We cannot determine with certainty the timing of initiation, the duration or the completion costs of current or future clinical trials and the manufacturing costs of our product candidates due to the inherently unpredictable nature of clinical development and manufacturing activities. Clinical development and manufacturing timelines, the probability of success and development costs can differ materially from expectations. We anticipate that we will make determinations as to which product candidates to pursue and how much funding to direct to each product candidate on an ongoing basis in response to the results of ongoing and future clinical trials, regulatory developments and our ongoing assessments as to each product candidate’s commercial potential. In addition, we cannot forecast to what degree our licensing, supply and distribution arrangements would affect our development plans and capital requirements.

Current wording

We expect our research and development expenses to decrease in 2024 compared to 2023 based on our planned clinical development and manufacturing activities, as we plan to transition to commercialization efforts for the potential launch of our first product in the fourth quarter of 2024. However, the timing for regulatory approvals is outside our control, may be delayed and is uncertain. We cannot determine with certainty the timing of initiation, the duration or the completion costs of current or future clinical trials and the manufacturing costs of our product candidates due to the inherently unpredictable nature of clinical development and manufacturing activities. Clinical development and manufacturing timelines, the probability of success and development costs can differ materially from expectations. We anticipate that we will make determinations as to which product candidates to pursue and how much funding to direct to each product candidate on an ongoing basis in response to the results of ongoing and future clinical trials, regulatory developments and our ongoing assessments as to each product candidate’s commercial potential. In addition, we cannot forecast to what degree our licensing, supply and distribution arrangements would affect our development plans and capital requirements.

Previous wording

We expect that our general and administrative expenses will remain consistent in 2024 compared to 2023. Pre-commercial launch activities related toneffy have been substantially paused, however ifneffy receives marketing approval, we will add sales and marketing personnel, infrastructure and programs to support commercialization activities. We expect to continue to incur audit, legal, regulatory and tax-related services associated with maintaining compliance with exchange listing and SEC requirements, director and officer insurance premiums, board of director fees, investor relations costs associated with operating as a public company, patent costs and defense, and general and administrative personnel.

Current wording

We expect that our general and administrative expenses will remain consistent in 2024 compared to 2023. Pre-commercial investment related toneffy has been substantially decreased, however ifneffy receives marketing approval, we will add sales and marketing personnel, infrastructure and programs to support commercialization activities. We expect to continue to incur audit, legal, regulatory and tax-related services associated with maintaining compliance with exchange listing and SEC requirements, director and officer insurance premiums, board of director fees, investor relations costs associated with operating as a public company, patent costs and defense, and general and administrative personnel.

Previous wording

Revenues. There was no revenue under collaboration agreements for the three months ended March 31, 2024, and less than $0.1 million in revenues for the three months ended March 31, 2023. The revenues for the three months ended March 31, 2023 includes the recognition of revenue for the portion of upfront and clinical and regulatory milestone payments under our collaboration agreement with Alfresa that have been allocated to research and development services provided for during that period. We expect revenues to fluctuate in future periods based on our ability to meet various regulatory milestones, and contingent on successfully obtaining regulatory approval forneffyin the licensed regions, commercial milestones, royalties or transfer price earned from our partner’s net sales and the supply of commercial product as set forth in these agreements.

Current wording

Revenues. There was $0.5 million in revenue under collaboration agreements for the three months ended June 30, 2024, and less than $0.1 million in revenues for the three months ended June 30, 2023. The revenues for the three months ended June 30, 2024 includes the recognition of revenue for the delivery of the license forneffyin the Seqirus Territory in combination with the transfer of know-how under our license and distribution agreement with Seqirus. The revenues for the three months ended June 30, 2023 includes the recognition of revenue for the portion of upfront and clinical and regulatory milestone payments under our collaboration agreement with Alfresa Pharma Corporation (“Alfresa”) that have been allocated to research and development services provided for during that period. We expect revenues to fluctuate in future periods based on our ability to meet various regulatory milestones, and contingent on successfully obtaining regulatory approval forneffyin the licensed regions, commercial milestones, royalties or transfer price earned from our partner’s net sales and the supply of commercial product as set forth in these agreements.

Previous wording

General and Administrative Expenses. General and administrative expenses were $8.0 million and $12.2 million for the three months ended March 31, 2024 and 2023, respectively. The decrease of $4.2 million was primarily due to a $3.4 million decrease in pre-commercial launch activities related toneffy, a $0.4 million decrease in payroll-related expenses, a $0.4 million decrease in consulting fees, a $0.3 million decrease in legal expenses, and a $0.5 million decrease in other operating expenses. These aggregated decreases were partially offset by a $0.8 million increase in stock-based compensation.

Current wording

General and Administrative Expenses. General and administrative expenses were $8.9 million and $13.3 million for the three months ended June 30, 2024 and 2023, respectively. The decrease of $4.4 million was primarily due to a $3.8 million decrease in pre-commercial launch activities related toneffy, a $0.7 million decrease in consulting fees, a $0.5 million decrease in legal fees, and a $0.4 million decrease in other operating expenses. These aggregated decreases were partially offset by a $1.0 million increase in stock-based compensation.

Previous wording

Research and Development Expenses. Research and development expenses were $5.2 million and $6.6 million for the three months ended March 31, 2024 and 2023, respectively. The decrease of $1.3 million was primarily due to a $2.5 million decrease in device development expenses and a $0.2 million decrease in other operating expenses. These aggregated decreases were partially offset by a $1.1 million increase in clinical trial costs associated with neffyand a $0.3 million increase in stock-based compensation.

Current wording

Research and Development Expenses. Research and development expenses were $12.1 million and $13.9 million for the six months ended June 30, 2024 and 2023, respectively. The decrease of $1.7 million was primarily due to a $3.9 million decrease in product development expenses, a $1.1 million decrease in consulting fees, and a $0.4 million decrease in other operating expenses. These aggregated decreases were partially offset by a $2.1 million increase in in-process research and development expense related to an EMA regulatory milestone liability under the Recordati Termination Agreement, a $1.0 million increase in clinical trial costs associated with neffy, and a $0.6 million increase in stock-based compensation.

Previous wording

Other Income, Net. Other income, net was $2.9 million and $3.8 million for the three months ended March 31, 2024 and 2023, respectively. The decrease of $0.9 million was primarily due to a $0.6 million decrease in interest income from our cash, cash equivalents, and short-term investments, and $0.3 million from the sale of in-process research and development obtained in the Merger, which occurred in the three months ended March 31, 2023.

Current wording

Other Income, Net. Other income, net was $5.7 million and $7.0 million for the six months ended June 30, 2024 and 2023, respectively. The decrease of $1.3 million was primarily due to a $1.1 million decrease in interest income from our cash, cash equivalents, and short-term investments, $0.3 million from the sale of in-process research and development obtained in the Merger, which occurred in the six months ended June 30, 2023, and a $0.2 million decrease in other items. These aggregated decreases were partially offset by a $0.3 million increase in net amortization and accretion associated with our short-term investments.

Previous wording

Since our inception, we have not generated any revenue from any product sale and have incurred significant operating losses and negative cash flows from our operations. We have not yet commercialized any of our product candidates and we do not expect to generate revenue from sales of any product candidates until the second half of 2024 or after, if at all. We have funded our operations to date primarily with proceeds from the Merger, the sale of preferred and common stock, revenue earned under collaboration, licensing, supply and distribution agreements and bank debt. From inception to March 31, 2024, we have raised $262.3 million in cash, cash equivalents and short-term investments, net of transaction costs, from the Merger, net proceeds of $76.3 million from the issuance of convertible preferred and common stock, $27.8 million from our collaboration, licensing, supply and distribution arrangements, and $10.0 million from bank debt. As of March 31, 2024, we had cash, cash equivalents, and short-term investments of $223.6 million.

Current wording

Since our inception, we have not generated any revenue from any product sale and have incurred significant operating losses and negative cash flows from our operations. We have not yet commercialized any of our product candidates and we do not expect to generate revenue from sales of any product candidates until the fourth quarter of 2024 or after, if at all. We have funded our operations to date primarily with proceeds from the Merger, the sale of preferred and common stock, revenue earned under collaboration, licensing, supply and distribution agreements and bank debt. From inception to June 30, 2024, we have raised $262.3 million in cash, cash equivalents and short-term investments, net of transaction costs, from the Merger, net proceeds of $76.3 million from the issuance of convertible preferred and common stock, $28.5 million from our collaboration, licensing, supply and distribution arrangements, and $10.0 million from bank debt. As of June 30, 2024, we had cash, cash equivalents, and short-term investments of $218.7 million.

Previous wording

The following table summarizes our cash flows for the three months ended March 31, 2024 and 2023 (in thousands):

Current wording

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

Previous wording

During the three months ended March 31, 2024, net cash used in operating activities was $6.7 million. This consisted primarily of a net loss of $10.3 million, an increase in our operating liabilities of $1.3 million, a decrease in our operating assets of $0.9 million, and non-cash charges of $1.3 million. The increase in our operating liabilities was primarily due to an increase in accounts payable and accrued liabilities of $1.3 million. The decrease in our operating assets was primarily due to a decrease in prepaid and other assets of $0.9 million. The non-cash charges consisted of non-cash stock-based compensation of $3.3 million, partially offset by $2.0 million in net amortization of discounts on short-term investments.

Current wording

During the six months ended June 30, 2024, net cash used in operating activities was $14.0 million. This consisted primarily of a net loss of $22.8 million, an increase in our operating liabilities of $4.4 million, a decrease in our operating assets of $1.6 million, and non-cash charges of $2.8 million. The increase in our operating liabilities was primarily due to an increase in accounts payable and accrued liabilities of $4.4 million. The decrease in our operating assets was primarily due to a decrease in prepaid and other assets of $1.6 million. The non-cash charges consisted of non-cash stock-based compensation of $6.7 million, partially offset by $3.9 million in net amortization of discounts on short-term investments.

Previous wording

During the three months ended March 31, 2023, net cash used in operating activities was $12.4 million. This consisted primarily of a net loss of $15.0 million, an increase in our operating liabilities of $1.6 million, a decrease in our operating assets of $0.4 million, and non-cash charges of $0.5 million. The increase in our operating liabilities was primarily due to an increase in accounts payable and accrued liabilities of $4.8 million, partially offset by a decrease in contract liability of $3.1 million. The decrease in our operating assets was primarily due to a decrease in prepaid and other assets of $0.4 million. The non-cash charges consisted of non-cash stock-based compensation of $2.3 million, partially offset by $1.8 million in net amortization of discounts on short-term investments.

Current wording

During the six months ended June 30, 2023, net cash used in operating activities was $29.1 million. This consisted primarily of a net loss of $32.3 million, an increase in our operating liabilities of $1.8 million, a decrease in our operating assets of $0.6 million, and non-cash charges of $0.8 million. The increase in our operating liabilities was primarily due to an increase in accounts payable and accrued liabilities of $5.0 million, partially offset by a decrease in contract liability of $3.1 million. The decrease in our operating assets was primarily due to a decrease in prepaid and other assets of $0.6 million. The non-cash charges consisted of non-cash stock-based compensation of $4.3 million, partially offset by $3.6 million in net amortization of discounts on short-term investments.

Previous wording

During the three months ended March 31, 2024, the cash and cash equivalents used in investing activities was $8.5 million. This consisted primarily of purchases of short-term investments of $63.4 million, maturities of short-term investments of $55.0 million, and purchases of property and equipment of $0.1 million. During the three months ended March 31, 2023, the cash and cash equivalents used in investing activities was $111.5 million. This consisted primarily of purchases of short-term investments of $131.4 million, maturities of short-term investments of $20.0 million, and purchases of property and equipment of $0.2 million.

Current wording

During the six months ended June 30, 2024, the cash and cash equivalents used in investing activities was $21.2 million. This consisted primarily of purchases of short-term investments of $151.0 million, maturities of short-term investments of $130.0 million, and purchases of property and equipment of $0.1 million. During the six months ended June 30, 2023, the cash and cash equivalents used in investing activities was $66.6 million. This consisted primarily of purchases of short-term investments of $131.4 million, maturities of short-term investments of $65.0 million, and purchases of property and equipment of $0.2 million.

Previous wording

During the three months ended March 31, 2024, the cash and cash equivalents provided by financing activities was $0.3 million, which consisted of proceeds from stock option exercises. During the three months ended March 31, 2023, the cash and cash equivalents provided by financing activities was $1.3 million, which consisted of proceeds from stock option exercises.

Current wording

During the six months ended June 30, 2024, the cash and cash equivalents provided by financing activities was $0.8 million, which consisted of proceeds from stock option exercises and the employee stock purchase plan. During the six months ended June 30, 2023, the cash and cash equivalents provided by financing activities was $4.2 million, which consisted of proceeds from stock option exercises and the employee stock purchase plan.

Previous wording

During the three months ended March 31, 2024, there were no material changes to our critical accounting policies. Our critical accounting policies are described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Significant Judgments and Estimates” in our Annual Report on Form 10-K filed with the SEC on March 21, 2024 and Note 2 - Summary of Significant Accounting Policies to our unaudited condensed consolidated financial statements appearing in Part I, Item 1 of this Quarterly Report on Form 10-Q.

Current wording

During the six months ended June 30, 2024, there were no material changes to our critical accounting policies. Our critical accounting policies are described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Significant Judgments and Estimates” in our Annual Report on Form 10-K filed with the SEC on March 21, 2024 and Note 2 - Summary of Significant Accounting Policies to our unaudited condensed consolidated financial statements appearing in Part I, Item 1 of this Quarterly Report on Form 10-Q.

Previous wording

We are an emerging growth company, as defined in the JOBS Act. For so long as we remain an emerging growth company, we are permitted and intend to rely on certain exemptions from various public company reporting requirements, including not being required to have our internal control over financial reporting audited by our independent registered public accounting firm pursuant to Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and any golden parachute payments not previously approved.

Current wording

We are an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). For so long as we remain an emerging growth company, we are permitted and intend to rely on certain exemptions from various public company reporting requirements, including not being required to have our internal control over financial reporting audited by our independent registered public accounting firm pursuant to Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and any golden parachute payments not previously approved.