What changed in this filing

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Item 2. Management’s Discussion and Analysis

2024-08-05 compared with 2024-05-15 · 138 added, 56 removed, 167 unchanged (54% of the section changed)

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Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties.

As a result of many factors, including those factors set forth in the “Risk Factors” section of this Quarterly Report on Form 10-Q, our actual results could differ materially from the results described in, or implied by, the forward-looking statements contained in the following discussion and analysis.

As a result of many factors, including those factors set forth in the “Risk Factors” in Part II, Item 1A of this Quarterly Report on Form 10-Q, our actual results could differ materially from the results described in, or implied by, the forward-looking statements contained in the following discussion and analysis.

We are a multi-asset, clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and diseases caused by multi-drug resistant (“MDR”) bacterial infections with high unmet need.

Our wholly-owned lead product candidate, SPR720, is an oral antimicrobial agent in development for the treatment of nontuberculous mycobacterial (“NTM”)

pulmonary disease, a rare orphan disease.

Our wholly-owned lead product candidate, SPR720, is an oral agent in development for the first-line treatment of nontuberculous mycobacterial (“NTM”) pulmonary disease, a rare disease.

We believe that SPR720, if successfully developed and approved, has the potential to be the first approved oral agent for NTM pulmonary disease in treatment-naïve and treatment-experienced and non-refractory patients.

Our partnered programs consist of tebipenem HBr and SPR206.

Tebipenem HBr is designed to be the first oral carbapenem-class antibiotic for use to treat complicated urinary tract infections (“cUTIs”), including pyelonephritis, caused by certain microorganisms, in adult patients who have limited oral treatment options.

SPR206 is an IV-administered antibiotic that has shown activity in preclinical studies against MDR Gram-negative pathogens, including carbapenem-resistant Enterobacterales, Acinobacter baumannii and Pseudomonas aeruginosa .

We are developing SPR206 to treat MDR Gram-negative bacterial infections in the hospital setting.

We believe that our novel product candidates, if successfully developed and approved, could provide meaningful benefits to patients suffering from serious rare orphan diseases and life-threatening bacterial infections, in both the community and hospital settings.

Tebipenem HBr is in development to potentially be the first oral carbapenem to treat complicated urinary tract infections (“cUTIs”), including pyelonephritis, caused by certain microorganisms, in adult patients.

SPR206 is an IV-administered antibiotic being developed as an innovative option to treat MDR Gram-negative bacterial infections in the hospital setting.

We believe that our novel product candidates, if successfully developed and approved, could provide meaningful benefits to patients suffering from serious rare diseases and life-threatening bacterial infections, in both the community and hospital settings.

Since our inception in 2013, we have focused substantially all of our efforts and financial resources on acquiring and developing product and technology rights, building our intellectual property portfolio and conducting research and development activities for our product candidates.

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Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our product candidates.

As of March 31, 2024, we had an accumulated deficit of $403.7 million, and cash and cash equivalents of $82.3 million.

As of June 30, 2024, we had an accumulated deficit of $421.6 million, and cash and cash equivalents of $63.5 million.

We expect to continue to incur significant expenses and increasing operating losses for at least the next several years.

We believe that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements for at least 12 months from the issuance of the financial statements included in this report.

Based on our cash and cash equivalents as of March 31, 2024, we believe that our cash runway will be sufficient to fund us into late 2025.

We believe that our existing cash and cash equivalents, together with expected collections from our collaboration receivables – related party, will enable us to fund our operating expenses and capital expenditure requirements for at least 12 months from the issuance of the financial statements included in this report.

Based on our cash and cash equivalents as of June 30, 2024, we believe that our cash runway will be sufficient to fund our operating expenses and capital expenditure requirements into late 2025.

During this period, we plan to prioritize advancing SPR720 to key Phase 2 milestones, advancing the Phase 3 clinical trial activities for tebipenem HBr under our GSK License Agreement and advancing SPR206 Phase 2 activities contingent on obtaining non-dilutive financing.

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If we are not able to secure adequate additional funding, we plan to make reductions in spending.

In that event, we may have to delay, scale back, or eliminate some or all of our planned clinical trials and research stage programs.

In that event, we may have to delay, scale back, or eliminate some or all of our planned clinical trials.

We will not generate revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for our product candidates.

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If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations.

Recent Developments

Enrollment has concluded, with 25 patients enrolled in the Phase 2a proof-of-concept clinical trial evaluating SPR720 in NTM-PD.

The last patient received the first dose in July 2024.

Preliminary data on SPR720’s early bactericidal activity, as assessed by the change in NTM bacterial load over the treatment course of 56 days, are expected in the fourth quarter of 2024.

The rate of change in log 10 Colony Forming Units per milliliter (CFU/mL), which is the trial’s primary endpoint, is being measured, along with the rate of change in Time to Positivity, which is a key secondary endpoint.

The double-blinded, placebo-controlled, trial enrolled treatment-naïve and treatment-experienced patients with non-refractory NTM-PD due to Mycobacterium avium complex in 3 treatment groups (placebo, SPR720 500 mg and SPR720 1000 mg dosed QD).

Additional secondary endpoints include assessments of clinical response, pharmacokinetics (“PK”), and safety and tolerability.

Dosing completed in two Phase 1 clinical studies evaluating SPR720 in healthy volunteers:

i) a bronchoalveolar lavage (“BAL”) study assessing intrapulmonary PK (epithelial lung fluid and alveolar macrophage) of SPR719, the active moiety of the prodrug SPR720, and ii) a study evaluating changes in plasma PK when SPR720 is co-administered with azithromycin and ethambutol.

Topline results from both studies are also expected to be disclosed in the fourth quarter of 2024.

Tebipenem HBr

In July 2024, an additional contract modification of $11.7 million was executed under our existing contract with BARDA, increasing the total committed funding under this award to $59.3 million with no change to the period of performance.

The additional funding is expected to provide support for clinical development activities for tebipenem HBr.

In March 2024, SPR206 was awarded Fast Track designation by the FDA for treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia due to carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex and carbapenem-resistant Pseudomonas aeruginosa.

Components of Our Results of Operations

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Grant Revenue

We expect a portion of our revenue for the next few years will continue to be derived from payments under our active government awards and any awards that we may enter into in the future.

We expect a portion of our revenue for the next few years will continue to be derived from payments under our active government awards and any awards that we may receive in the future.

Collaboration Revenue

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Interest Income (Expense)

Interest income (expense) during the three months ended March 31, 2024 and 2023 consists of interest expense related to the significant financing component related to the GSK License Agreement and interest earned on our cash equivalents, which are primarily invested in money market accounts, as well as interest earned on our investments in marketable securities.

Interest income (expense) during the three and six months ended June 30, 2024 and 2023 consists of interest expense related to the significant financing component related to the GSK License Agreement and interest earned on our cash equivalents, which are primarily invested in money market accounts, as well as interest earned on our investments in marketable securities.

Other Income (Expense), Net

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Results of Operations

Comparison of the Three Months Ended March 31, 2024 and 2023

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

Three Months Ended March 31,

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

The following table summarizes our results of operations for the three months ended June 30, 2024 and 2023 (in thousands):

Three Months Ended June 30,

Grant revenue

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Grant Revenue

Three Months Ended March 31,

Three Months Ended June 30,

BARDA Contract (Tebipenem HBr)

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Total grant revenue

Grant revenue recognized during the three months ended March 31, 2024 and 2023 consisted of the reimbursement of qualifying expenses incurred in connection with our various government awards.

The increase in grant revenue during the three months ended March 31, 2024 was primarily due to an increase of $4.4 million in qualified expenses incurred under our Biomedical Advanced Research and Development Authority (“BARDA”) contract for tebipenem HBr, partially offset by a decrease of $0.7 million under our U.S.

Grant revenue recognized during the three months ended June 30, 2024 and 2023 consisted of the reimbursement of qualifying expenses incurred in connection with our various government awards.

The increase in grant revenue during the three months ended June 30, 2024 was primarily due to an increase of $3.1 million in qualified expenses incurred under our Biomedical Advanced Research and Development Authority (“BARDA”) contract for tebipenem HBr, partially offset by a decrease of $0.8 million under our U.S.

National Institute of Allergy and Infectious Diseases (“NIAID”) agreement relating to SPR206.

Collaboration Revenue

During the three months ended March 31, 2024, we recognized $4.1 million in collaboration revenue related to our agreement with GSK and $0.1 million in collaboration revenue related to our agreement with Pfizer.

During the three months ended March 31, 2023, we recognized $0.5 in collaboration revenue related to our agreement with GSK and $0.2 million in collaboration revenue related to our agreement with Pfizer.

Three Months Ended June 30,

GSK (Tebipenem HBr)

Pfizer (SPR206)

Total collaboration revenue

During the three months ended June 30, 2024, we recognized $5.9 million in collaboration revenue related to our agreement with GSK and $0.1 million in collaboration revenue related to our agreement with Pfizer.

During the three months ended June 30, 2023, we recognized $0.5 million in collaboration revenue related to our agreement with GSK and $0.3 million in collaboration revenue related to our agreement with Pfizer.

Research and Development Expenses

Three Months Ended March 31,

Three Months Ended June 30,

Direct research and development expenses by program:

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Total research and development expenses

Direct costs related to our SPR720 program increased by $2.6 million during the three months ended March 31, 2024, as compared to the three months ended March 31, 2023, due to increased clinical activity during the period related to our ongoing Phase 2a clinical trial of SPR720.

We expect to continue to incur direct costs related to SPR720 as we continue to screen and enroll patients and progress clinical activities.

Direct costs related to our tebipenem HBr program increased by $6.1 million during the three months ended March 31, 2024, compared to the three months ended March 31, 2023, due to continued clinical activities related to our pivotal Phase 3 trial of tebipenem HBr, which we initiated in the fourth quarter of 2023.

Direct costs related to our SPR206 program decreased by $0.5 million during the three months ended March 31, 2024, primarily due to decreased preclinical activity and decreased expenses associated with formulation development, manufacturing process and manufacturing of clinical trial material during the period.

Direct costs related to our SPR720 program increased by $3.5 million during the three months ended June 30, 2024, as compared to the three months ended June 30, 2023, due to increased clinical activity during the period related to our Phase 2a clinical trial of SPR720, which completed enrollment in the second quarter of 2024.

We expect to continue to incur direct costs related to SPR720 as we progress clinical activities.

Direct costs related to our tebipenem HBr program increased by $12.0 million during the three months ended June 30, 2024, compared to the three months ended June 30, 2023, due to continued clinical activities related to our pivotal Phase 3 clinical trial of tebipenem HBr, which we initiated in the fourth quarter of 2023.

Direct costs related to our tebipenem HBr program during the three months ended June 30, 2024 reflect a $1.6 million reduction to expense related to a repurchase of drug substance material by GSK.

Direct costs related to our SPR206 program decreased by $0.9 million during the three months ended June 30, 2024, primarily due to decreased preclinical activity.

The decrease in personnel-related costs of $0.3 million was primarily a result of decreased research and development headcount costs.

Personnel-related costs for the three months ended March 31, 2024 and 2023 included share-based compensation expense of $0.7 million and $0.8 million, respectively.

Personnel-related costs during the three months ended June 30, 2023 included retention bonus payments in connection with our restructuring in May 2022.

Personnel-related costs for the three months ended June 30, 2024 and 2023 included share-based compensation expense of $0.7 million and $0.6 million, respectively.

Facility-related and other costs primarily reflect costs related to supporting our research and development staff.

General and Administrative Expenses

Three Months Ended March 31,

Three Months Ended June 30,

Personnel related (including share-based compensation)

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The decrease in personnel-related costs of $0.8 million was primarily a result of decreased headcount costs in our general and administrative functions during the period.

Personnel-related costs during the three months ended March 31, 2023 included retention bonus payments related to our restructuring in May 2022.

Personnel-related costs for the three months ended March 31, 2024 and 2023 included share-based compensation expense of $1.3 million and $1.4 million, respectively.

The decrease in professional and consultant fees of $0.1 million was primarily due to varying legal and consulting expenses incurred in the three months ended March 31, 2024.

Personnel-related costs during the three months ended June 30, 2023 included retention bonus payments in connection with our restructuring in May 2022.

Personnel-related costs for the three months ended June 30, 2024 and 2023 included share-based compensation expense of $1.4 million and $1.3 million, respectively.

The increase in professional and consultant fees of $0.1 million was primarily due to varying legal and consulting expenses incurred in the three months ended June 30, 2024.

Facility-related and other costs primarily reflect costs related to supporting our general and administrative staff.

Other Income (Expense), Net

Other income (expense), net was $1.3 million for the three months ended March 31, 2024, compared to $1.0 million for the three months ended March 31, 2023.

Total other income for the three months ended March 31, 2024 included $1.3 million of interest income, of which $0.4 million related to the significant financing component recognized under the GSK License Agreement, offset by immaterial fluctuations in unrealized foreign currency.

Total other income for the three months ended March 31, 2023 included $1.0 million of interest income, offset by immaterial changes primarily due to fluctuations in unrealized foreign currency.

Other income (expense), net was $1.2 million for the three months ended June 30, 2024, compared to $1.0 million for the three months ended June 30, 2023.

Total other income for the three months ended June 30, 2024 included $1.2 million of interest income, of which $0.4 million related to the significant financing component recognized under the GSK License Agreement, offset by immaterial fluctuations in unrealized foreign currency.

Total other income for the three months ended June 30, 2023 included $1.0 million of interest income, offset by changes primarily due to fluctuations in unrealized foreign currency.

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

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

Six Months Ended June 30,

Grant revenue

Collaboration revenue - related party

Collaboration revenue

Total revenues

Operating expenses:

Research and development

General and administrative

Total operating expenses

Loss from operations

Other income (expense):

Interest income

Other income (expense), net

Total other income (expense), net

Grant Revenue

Six Months Ended June 30,

BARDA Contract (Tebipenem HBr)

NIAID Contract (SPR206)

Total grant revenue

Grant revenue recognized during the six months ended June 30, 2024 and 2023 consisted of the reimbursement of qualifying expenses incurred in connection with our various government awards.

The increase in grant revenue during the six months ended June 30, 2024 was primarily due to an increase of $7.5 million in qualified expenses incurred under our BARDA contract for tebipenem HBr, partially offset by a decrease of $1.5 million under our NIAID agreement relating to SPR206.

Collaboration Revenue

Six Months Ended June 30,

GSK (Tebipenem HBr)

Pfizer (SPR206)

Total collaboration revenue

During the six months ended June 30, 2024, we recognized $10.0 million in collaboration revenue related to our agreement with GSK and $0.3 million in collaboration revenue related to our agreement with Pfizer.

During the six months ended June 30, 2023, we

recognized $1.0 million in collaboration revenue related to our agreement with GSK and $0.5 million in collaboration revenue related to our agreement with Pfizer.

Research and Development Expenses

Six Months Ended June 30,

Direct research and development expenses by program:

Tebipenem HBr

Unallocated expenses:

Personnel related (including share-based compensation)

Facility related and other

Total research and development expenses

Direct costs related to our SPR720 program increased by $6.1 million during the six months ended June 30, 2024, as compared to the six months ended June 30, 2023, due to increased clinical activity during the period related to our Phase 2a clinical trial of SPR720, which completed enrollment in the second quarter of 2024.

We expect to continue to incur direct costs related to SPR720 as we progress clinical activities.

Direct costs related to our tebipenem HBr program increased by $18.1 million during the six months ended June 30, 2024, compared to the six months ended June 30, 2023, due to continued clinical activities related to our pivotal Phase 3 clinical trial of tebipenem HBr, which we initiated in the fourth quarter of 2023.

Direct costs related to our tebipenem HBr program during the six months ended June 30, 2024 reflect a $1.6 million reduction to expense related to a repurchase of drug substance material by GSK.

Direct costs related to our SPR206 program decreased by $1.4 million during the six months ended June 30, 2024, primarily due to decreased preclinical activity.

The decrease in personnel-related costs of $0.5 million was primarily a result of decreased research and development headcount costs.

Personnel-related costs during the six months ended June 30, 2023 included retention bonus payments in connection with our restructuring in May 2022.

Personnel-related costs for the six months ended June 30, 2024 and 2023 included share-based compensation expense of $1.4 million and $1.4 million, respectively.

Facility-related and other costs primarily reflect costs related to supporting our research and development staff.

General and Administrative Expenses

Six Months Ended June 30,

Personnel related (including share-based compensation)

Professional and consultant fees

Facility related and other

Total general and administrative expenses

The decrease in personnel-related costs of $2.0 million was primarily a result of decreased headcount costs in our general and administrative functions during the period.

Personnel-related costs during the six months ended June 30, 2023 included retention bonus payments in connection with our restructuring in May 2022.

Personnel-related costs for the six months ended June 30, 2024 and 2023 included share-based compensation expense of $2.7 million and $2.6 million, respectively.

Changes in professional and consultant fees were primarily due to varying legal and consulting expenses incurred in the six months ended June 30, 2024.

Facility-related and other costs primarily reflect costs related to supporting our general and administrative staff.

Other Income (Expense), Net

Other income (expense), net was $2.5 million for the six months ended June 30, 2024, compared to $1.9 million for the six months ended June 30, 2023.

Total other income for the six months ended June 30, 2024 included $2.5 million of interest income, of which $0.8 million related to the significant financing component recognized under the GSK License Agreement, offset by immaterial fluctuations in unrealized foreign currency.

Total other income for the six months ended June 30, 2023 included $1.9 million of interest income, offset by immaterial changes primarily due to fluctuations in unrealized foreign currency.

Liquidity and Capital Resources

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To date, we have funded our operations with payments received under license and collaboration agreements and funding from government contracts, and from the proceeds of multiple common stock offerings.

As of March 31, 2024, we had cash and cash equivalents of $82.3 million.

As of June 30, 2024, we had cash and cash equivalents of $63.5 million.

We filed a new universal shelf registration statement on Form S-3 with the SEC on March 15, 2024 (the “2024 Form S-3”), which became effective on March 22, 2024, and pursuant to which we registered for sale up to $300.0 million of any combination of our common stock, preferred stock, debt securities, warrants, rights and/or units from time to time and at prices and on terms that we may determine, including up to $75.0 million of our common stock available for issuance pursuant to a Controlled Equity Offering Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co.

Under the Sales Agreement, Cantor may sell shares of our common stock by any method permitted by law deemed to be an “at-the-market” offering as defined in Rule 415 of the Securities Act of 1933, as amended (the “Securities Act”), subject to the terms of the Sales Agreement.

During the three months ended March 31, 2024 and year-to-date, we did not sell any shares of our common stock under the Sales Agreement.

The following table summarizes our sources and uses of cash for the three months ended March 31, 2024 and 2023:

Three Months Ended March 31,

Cash provided by (used in) operating activities

Net increase (decrease) in cash and cash equivalents

During the three and six months ended June 30, 2024 and year-to-date, we did not sell any shares of our common stock under the Sales Agreement.

The following table summarizes our sources and uses of cash for the six months ended June 30, 2024 and 2023:

Six Months Ended June 30,

Cash used in operating activities

Net decrease in cash and cash equivalents

Operating Activities

Net cash provided by changes in operating activities for the three months ended March 31, 2024 was $5.9 million, primarily resulting from our net loss of $12.7 million, adjusted for a net decrease in non-cash items of $2.3 million (primarily stock-based compensation).

Net cash provided by changes in our operating assets and liabilities was $16.3 million and consisted primarily of a $23.3 million decrease in our related party collaboration receivable, due to the receipt of the first installment payment from GSK (see Note 9 - License, Collaboration and Service Agreements), a $4.2 million increase in deferred revenue, a $3.5 million net increase in receivables, a $1.7 million increase in accounts payable and a decrease of $1.2 million in accrued expenses.

Net cash used in operating activities for the three months ended March 31, 2023 was $12.9 million, primarily resulting from our net loss of $13.3 million, adjusted for a net decrease in non-cash items of $2.5 million (primarily stock-based compensation).

Net cash used due to changes in our operating assets and liabilities was $2.1 million and consisted primarily of a $0.8 million net increase in receivables, a $0.2 million increase in prepaid expenses and other current assets, a decrease of $0.1 million in accrued expenses and a $0.7 million decrease in deferred revenue.

Net cash used in operating activities for the six months ended June 30, 2024 was $(12.8) million, primarily resulting from our net loss of $30.5 million, adjusted for a net decrease in non-cash items of $4.7 million (primarily stock-based compensation).

Net cash provided by changes in our operating assets and liabilities was $13.1 million and consisted primarily of a $21.4 million decrease in our related party collaboration receivable, primarily due to the receipt of the first installment payment from GSK (see Note 9 - License, Collaboration and Service Agreements), a $10.2 million decrease in deferred revenue, a $3.2 million net increase in receivables, a $3.5 million increase in accrued expenses, a $1.3 million increase in accounts payable and a $1.0 million decrease in prepaid expenses.

Net cash used in operating activities for the six months ended June 30, 2023 was $31.4 million, primarily resulting from our net loss of $25.2 million, adjusted for net decrease in non-cash items of $4.7 million (primarily stock-based compensation).

Net cash used due to changes in our operating assets and liabilities was $11.0 million and consisted primarily of a $5.2 million increase in prepaid expenses and other current assets, a $1.0 million net increase in receivables, a decrease of $3.4 million in accrued expenses and a $1.5 million decrease in deferred revenue.

Changes in accounts payable, accrued expenses and other current liabilities and prepaid expenses and other current assets in all periods were generally due to the advancement of our programs and the timing of vendor invoicing and payments.

deferred revenue are primarily related to the GSK License Agreement and our license agreement with Pfizer.

Changes in deferred revenue are primarily related to the GSK License Agreement and our license agreement with Pfizer.

Changes in collaboration receivable related to the GSK License Agreement.

Investing Activities

We did not undertake any investing activities during both the three months ended March 31, 2024 and 2023.

We did not undertake any investing activities during the six months ended June 30, 2024 or 2023.

Financing Activities

We did not undertake any financing activities during both the three months ended March 31, 2024 and 2023.

We did not undertake any financing activities during the six months ended June 30, 2024 or 2023.

Funding Requirements

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• the extent to which we in-license or acquire other products and technologies.

As of March 31, 2024, we had cash and cash equivalents of $82.3 million.

As of June 30, 2024, we had cash and cash equivalents of $63.5 million.

In accordance with ASU 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40), we are required to evaluate whether there are conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern from the issuance date of our financial statements.

Based on our cash and cash equivalents as of March 31, 2024, we believe that our cash runway will be sufficient to fund us into late 2025.

Based on our cash and cash equivalents as of June 30, 2024, we believe that our cash runway will be sufficient to fund us into late 2025.

Beyond this point we will need additional funding, which we expect will primarily consist of raising additional capital through some combination of equity or debt financings, potential new collaborations, additional grant funding and/or reducing cash expenditures.

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Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures or declaring dividends.

If we raise additional funds through collaborations, strategic alliances or

marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us.

If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us.

Global health, economic, and political crises, such as the COVID-19 pandemic, have resulted in ongoing volatility in financial markets.

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Contractual Obligations and Commitments

During the three months ended March 31, 2024, there have been no material changes to our contractual obligations and commitments outside the ordinary course of business from those described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Contractual Obligations and Commitments” in our Annual Report on Form 10-K for the year ended December 31, 2023.

During the three and six months ended June 30, 2024, there have been no material changes to our contractual obligations and commitments outside the ordinary course of business from those described under the heading “Management’s Discussion and

Analysis of Financial Condition and Results of Operations—Contractual Obligations and Commitments” in our Annual Report on Form 10-K for the year ended December 31, 2023.

Off-Balance Sheet Arrangements

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Quantitative and Qualitati ve Disclosures About Market Risk.

As of March 31, 2024, we had cash and cash equivalents of $82.3 million, consisting of cash and money market accounts.

As of June 30, 2024, we had cash and cash equivalents of $63.5 million, consisting of cash and money market accounts.

The primary objectives of our investment activities are to preserve principal, provide liquidity and maximize income without significantly increasing risk.

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interest rates.

We did not have any assets classified as marketable securities as of March 31, 2024.

We did not have any assets classified as marketable securities as of June 30, 2024.

As we incur research expenses in foreign countries, we face exposure to movements in foreign currency exchange rates, primarily the Euro, British Pound, Japanese Yen and Australian dollar against the U.S.

Historically, foreign currency fluctuations have not had a material impact on our consolidated financial statements.

Please note, that we are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information under this item.

Therefore, the above disclosure is discretionary.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis