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PROTHENA CORP PUBLIC LTD CO

For the period ended Sep 30, 2024. Filed Nov 12, 2024.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Sep 30, 2024 · Filed Nov 12, 2024

PRTA$7.97+1.0%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2024-06-30; filed 2024-08-08.

0001559053-24-000025

Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Current report: 10-Q

Period ended 2024-09-30; filed 2024-11-12.

0001559053-24-000032

Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 115 previous paragraphs and 111 current paragraphs.

75 unchanged; 32 reworded; 2 added; 5 removed; 3 previous and 2 current paragraphs rearranged.

Tables are not compared: 12 previous and 12 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (2)

Current report

In November 2024, we announced that we had initiated a Phase 1 first-in-human clinical trial to evaluate the safety, tolerability, immunogenicity, and pharmacokinetics of single ascending and multiple doses in healthy adults.
Removed paragraphs (5)

Previous report

Prothena is obligated to run a Phase 1 clinical trial for PRX019.

Previous report

We expect our R&D expenses to increase moderately in 2024 over the prior year due to an increase in expenses for our clinical programs.

Previous report

We expect our G&A expenses to increase in 2024 compared to the prior year, primarily related to anticipated higher personnel costs including share-based compensation.

Previous report

(2)Contractual obligations as of the filing date includes an additional $0.6 million, primarily for purchase commitments to our contract manufacturers.
Reworded paragraphs (32)

Previous wording

In addition to historical information, this Quarterly Report on Form 10-Q contains forward-looking statements which may cause our actual results to differ materially from expectations, plans and anticipated results discussed in forward-looking statements. Factors that could cause our actual results to differ materially include, but are not limited to, the risks and uncertainties set forth in the “Summary of Risks Affecting Our Business” at the beginning of this Quarterly Report on Form

Current wording

In addition to historical information, this Quarterly Report on Form 10-Q contains forward-looking statements which may cause our actual results to differ materially from expectations, plans and anticipated results discussed in forward-looking statements. Factors that could cause our actual results to differ materially include, but are not limited to, the risks and uncertainties set forth in the “Summary of Risks Affecting Our Business” at the beginning of this Quarterly Report on Form 10-Q, Part II Item 1A “Risk Factors” of this Quarterly Report on Form 10-Q, and in our other filings with the U.S. Securities and Exchange Commission.

Previous wording

Based on further analyses of data from the VITAL clinical trial and multiple in-depth discussions with the FDA, Prothena announced plans in February 2021, to advance birtamimab into the confirmatory Phase 3 AFFIRM-AL clinical trial in patients with Mayo Stage IV AL amyloidosis. AFFIRM-AL is a registration-enabling Phase 3 clinical trial that is being conducted with a primary endpoint of all-cause mortality at p<0.10 under a Special Protocol Assessment (SPA) agreement with the FDA. Patient enrollment is on track in the AFFIRM-AL trial and full topline trial results are expected between the fourth quarter of 2024 and the second quarter of 2025.

Current wording

Based on further analyses of data from the VITAL clinical trial and multiple in-depth discussions with the FDA, Prothena announced plans in February 2021, to advance birtamimab into the confirmatory Phase 3 AFFIRM-AL clinical trial in patients with Mayo Stage IV AL amyloidosis. AFFIRM-AL is a registration-enabling Phase 3 clinical trial that is being conducted with a primary endpoint of all-cause mortality at p<0.10 under a Special Protocol Assessment (“SPA”) agreement with the FDA. Patient enrollment is on track in the AFFIRM-AL trial and full topline trial results are expected in the first half of 2025.

Previous wording

Prasinezumab is the first anti-alpha synuclein antibody to advance into late-stage development. In March 2022, results from the analysis of part 2 of the Phase 2 PASADENA trial of prasinezumab were presented in an oral presentation by Roche at the International Conference on Alzheimer’s and Parkinson’s Diseases (“AD/PD 2022”). Results showed that participants with Parkinson’s disease who were treated with prasinezumab for two years (early-start group) showed slower decline of MDS-UPDRS Part III scores relative to participants treated with placebo in the first year and prasinezumab in the second year (delayed-start group), further supporting a potential effect on delaying motor progression in patients. In March 2024, Roche presented data at the AD/PD™ 2024 Alzheimer's & Parkinson's Diseases Conference from the long-term open-label extension of the PASADENA trial, which compared the prasinezumab population with a propensity score-balanced cohort of real-world data (RWD) Parkinson’s Progression Markers Initiative (PPMI). The data suggests that prasinezumab continued to show reduced motor and functional progression in prazinezumab-treated individuals with early-stage Parkinson’s disease compared to a real-world data arm on MDS-UPDRS Part III score (clinician-rated motor examination) OFF and ON symptomatic medication state and MDS-UPDRS Part II score (patient-reported motor experiences of daily living).

Current wording

Prasinezumab is the first anti-alpha synuclein antibody to advance into late-stage development. In March 2022, results from the analysis of part 2 of the Phase 2 PASADENA trial of prasinezumab were presented in an oral presentation by Roche at the International Conference on Alzheimer’s and Parkinson’s Diseases (“AD/PD 2022”). Results showed that participants with Parkinson’s disease who were treated with prasinezumab for two years (early-start group) showed slower decline of MDS-UPDRS Part III scores relative to participants treated with placebo in the first year and prasinezumab in the second year (delayed-start group), further supporting a potential effect on delaying motor progression in patients. In October 2024, Roche published results in Nature Medicine from the long-term open-label extension of the PASADENA trial, which compared the prasinezumab population with a propensity score-balanced cohort of real-world data (“RWD”) Parkinson’s Progression Markers Initiative (“PPMI”). The data suggests that prasinezumab continued to show reduced motor and functional progression in prazinezumab-treated individuals with early-stage Parkinson’s disease compared to a real-world data arm on MDS-UPDRS Part III score (clinician-rated motor examination) OFF and ON symptomatic medication state and MDS-UPDRS Part II score (patient-reported motor experiences of daily living).

Previous wording

We completed a Phase 1 clinical trial with coramitug in patients with hereditary forms of ATTR amyloidosis, in which coramitug was demonstrated to be safe and well tolerated.

Current wording

We completed a Phase 1 clinical trial with coramitug in patients with hereditary forms of ATTR amyloidosis, in which coramitug was demonstrated to be safe and well tolerated. In October 2024, these Phase 1 results were published in Amyloid, the official journal of the International Society of Amyloidosis.

Previous wording

A Phase 2 clinical trial of coramitug in approximately 99 patients with ATTR cardiomyopathy is being conducted by Novo Nordisk (NCT05442047).

Current wording

A Phase 2 clinical trial of coramitug in approximately 99 patients with ATTR amyloidosis with cardiomyopathy is being conducted by Novo Nordisk (NCT05442047).

Previous wording

In this first-in-human, randomized, placebo controlled, single ascending dose (SAD) clinical trial, healthy volunteers (n=19) were enrolled into three BMS-986446 dose level cohorts (low, medium or high dose) and randomized in a 3:1 drug to placebo ratio. Trial participants received a single dose of BMS-986446 or placebo intravenously (IV) and were followed for up to two months. The results of the trial found all three dose level cohorts of BMS-986446 to be generally safe and well tolerated, meeting the Phase 1 SAD trial primary objective. None of the treatment emergent adverse events (TEAE) were serious. No clinically relevant changes were observed in other safety parameters. BMS-986446 also met key pharmacokinetic (PK) and immunogenicity secondary endpoints. Plasma drug concentrations of BMS-986446 increased in a dose-proportional manner. Furthermore, BMS-986446 exposure in cerebrospinal fluid (CSF) was measured in the high dose cohort and based on the robust exposure of BMS-986446 in the CSF (day 29 CSF:Plasma ratio=0.2%), substantial target engagement is expected in the CNS. BMS-986446 had a desirable immunogenicity profile with no persistent BMS-986446-induced antidrug antibodies (ADAs) observed.

Current wording

In this first-in-human, randomized, placebo controlled, single ascending dose (“SAD”) clinical trial, healthy volunteers (n=19) were enrolled into three BMS-986446 dose level cohorts (low, medium or high dose) and randomized in a 3:1 drug to placebo ratio. Trial participants received a single dose of BMS-986446 or placebo intravenously (“IV”) and were followed for up to two months. The results of the trial found all three dose level cohorts of BMS-986446 to be generally safe and well tolerated, meeting the Phase 1 SAD trial primary objective. None of the treatment emergent adverse events (“TEAE”) were serious. No clinically relevant changes were observed in other safety parameters. BMS-986446 also met key pharmacokinetic (“PK”) and immunogenicity secondary endpoints. Plasma drug concentrations of BMS-986446 increased in a dose-proportional manner. Furthermore, BMS-986446 exposure in cerebrospinal fluid (“CSF”) was measured in the high dose cohort and based on the robust exposure of BMS-986446 in the CSF (day 29 CSF:Plasma ratio=0.2%), substantial target engagement is expected in the CNS. BMS-986446 had a desirable immunogenicity profile with no persistent BMS-986446-induced antidrug antibodies (“ADA”s) observed.

Previous wording

We are advancing our lead candidate, PRX012, as a next-generation approach for subcutaneous administration to improve access for patients with Alzheimer’s disease. In March 2022, we announced the FDA clearance of the IND for PRX012 and the initiation of a Phase 1 single ascending dose trial to investigate the safety, tolerability, immunogenicity, and pharmacokinetics of PRX012 in both healthy volunteers and patients with Alzheimer’s disease. In April 2022, we announced that the FDA granted Fast Track designation for PRX012 for the treatment of Alzheimer’s disease. The FDA’s Fast Track designation program is designed to expedite the development and review of drugs intended to treat a serious condition, such as Alzheimer’s disease, with evidence demonstrating the potential to address an unmet medical need. In January 2024, we announced that topline Phase 1 data from the single ascending dose trial and the initial multiple dose cohort (70 mg) supports once-monthly subcutaneous treatment and dose escalation. The ongoing Phase 1 trial continues as planned.

Current wording

We are advancing our lead candidate, PRX012, as a next-generation approach for subcutaneous administration to i address the unmet need of millions of patients with presymptomatic or early symptomatic Alzheimer's disease. In March 2022, we announced the FDA clearance of the IND for PRX012 and the initiation of a Phase 1 single ascending dose trial to investigate the safety, tolerability, immunogenicity, and pharmacokinetics of PRX012 in both healthy volunteers and patients with Alzheimer’s disease. In April 2022, we announced that the FDA granted Fast Track designation for PRX012 for the treatment of Alzheimer’s disease. The FDA’s Fast Track designation program is designed to expedite the development and review of drugs intended to treat a serious condition, such as Alzheimer’s disease, with evidence demonstrating the potential to address an unmet medical need. In January 2024, we announced that topline Phase 1 data from the single ascending dose trial and the initial multiple dose cohort (70 mg) supports once-monthly subcutaneous treatment and dose escalation. The ongoing Phase 1 trial continues as planned and we expect to report multiple clinical readouts starting in mid-2025 and continuing throughout the year.

Previous wording

PRX019 is an investigational antibody for the potential treatment of neurodegenerative diseases with an undisclosed target.

Current wording

PRX019 is an investigational antibody for the potential treatment of neurodegenerative diseases in development in collaboration with BMS.

Previous wording

There were no significant changes to our critical accounting policies and estimates during the six months ended June 30, 2024, from the critical accounting policies and estimates disclosed in Management's Discussion and Analysis of Financial Condition and Results of Operations in our 2023 Form 10-K.

Current wording

There were no significant changes to our critical accounting policies and estimates during the nine months ended September 30, 2024, from the critical accounting policies and estimates disclosed in Management's Discussion and Analysis of Financial Condition and Results of Operations in our 2023 Form 10-K.

Previous wording

Except as described in Note 2 to the Condensed Consolidated Financial Statements under the heading “Recent Accounting Pronouncements”, there have been no new accounting pronouncements or changes to accounting pronouncements during the six months ended June 30, 2024, as compared to the recent accounting pronouncements described in our 2023 Form 10-K, that are of significance or potential significance to us.

Current wording

Except as described in Note 2 to the Condensed Consolidated Financial Statements under the heading “Recent Accounting Pronouncements”, there have been no new accounting pronouncements or changes to accounting pronouncements during the nine months ended September 30, 2024, as compared to the recent accounting pronouncements described in our 2023 Form 10-K, that are of significance or potential significance to us.

Previous wording

Comparison of three and six months ended June 30, 2024 and 2023

Current wording

Comparison of three and nine months ended September 30, 2024 and 2023

Previous wording

Total revenue was $132.0 million and $4.0 million for thethree months ended June 30, 2024, and 2023, respectively and $132.1 million and$6.2 million for the six months ended June 30, 2024, and 2023, respectively.

Current wording

Total revenue was$1.0 million and $84.9 million for thethree months ended September 30, 2024, and 2023, respectively, and$133.0 million and$91.1 million for the nine months ended September 30, 2024, and 2023, respectively.

Previous wording

Collaboration revenue was $132.0 million and$132.0 million for thethree and six months ended June 30, 2024, compared to $4.0 million and$6.1 million for thethree and six months ended June 30, 2023, respectively. Collaboration revenue of$132.0 million for thethree and six months ended June 30, 2024, was related to revenue recognized under our Collaboration Agreement with BMS of which,$107.0 million was from the PRX019 Global License Agreement and PRX019 Phase 1 Clinical Trial Obligation and$25.0 million was related to BMS’s material rights for the US Rights and Global Rights for the TDP-43 Collaboration Target that were fulfilled on May 24, 2024 as a result of the expiration of the research term of the Collaboration Agreement. Collaboration revenue for the three and six months ended June 30, 2023, included revenue from BMS for US Development Services related to the Tau/PRX005 program. As of June 30, 2024, the Company does not have any remaining Tau US Development Services Obligations and has recognized all revenue from this performance obligation as of December 31, 2023. As of June 30, 2024, the Company has $15.4 million of deferred revenue related to the remaining performance obligations under the PRX019 Global License Agreement related to PRX019 Phase 1 Clinical Trial Obligations. See Note 7, “Significant Agreements” to the Condensed Consolidated Financial Statements regarding the Collaboration Agreement with BMS for more information.

Current wording

Collaboration revenue was$1.0 million and $133.0 million for thethree and nine months ended September 30, 2024, compared to $84.9 million and$91.0 million for thethree and nine months ended September 30, 2023, respectively. Collaboration revenue for the three and nine months ended September 30, 2024, was related to revenue recognized under our Collaboration Agreement with BMS. Collaboration revenue for thethree months ended September 30, 2024 related to PRX019 Phase 1 Clinical Trial Obligation. Collaboration revenue for thenine months ended September 30, 2024 included $107.9 million from the PRX019 Global License Agreement and PRX019 Phase 1 Clinical Trial Obligation and $25.0 million was related to BMS’s material rights for the US Rights and Global Rights for the TDP-43 Collaboration Target that expired unexercised on May 24, 2024 as a result of the expiration of the research term of the Collaboration Agreement.

Previous wording

License and intellectual property revenue for the six months ended June 30, 2024, and 2023 included $50,000 in each period, respectively, in license fees recognized under the License Agreement entered into on March 1, 2020, between the Company's wholly owned subsidiary, Prothena Biosciences Limited, and F. Hoffmann-La Roche Ltd.

Current wording

License and intellectual property revenue for the nine months ended September 30, 2024, and 2023 included $50,000 in each period, respectively, in license fees recognized under the License Agreement entered into on March 1, 2020, between the Company's wholly owned subsidiary, Prothena Biosciences Limited, and F. Hoffmann-La Roche Ltd.

Previous wording

Total operating expenses consist of R&D expenses, general and administrative (“G&A”) expenses. Our operating expenses were $73.6 million and $70.5 million for the three months ended June 30, 2024, and 2023 respectively, and $155.2 million and$129.0 millionfor thesix months ended June 30, 2024, and 2023 respectively.

Current wording

Total operating expenses consist of R&D expenses, general and administrative (“G&A”) expenses. Our operating expenses were$67.5 million and $74.6 million for the three months ended September 30, 2024, and 2023, respectively, and$222.7 million and$203.6 millionfor thenine months ended September 30, 2024, and 2023, respectively.

Previous wording

Our R&D expenses increased by$1.5 million or 3% for the three months ended June 30, 2024, and increased by$20.9 million or 21%, for the six months ended June 30, 2024, compared to the same period in the prior year. The increase for thethree and six months ended June 30, 2024, compared to the same period in the prior year was primarily due to higher clinical trial expenses primarily related to the PRX012 and birtamimab programs and higher personnel expenses offset in part by lower manufacturing expenses.

Current wording

Our R&D expenses decreased by$7.2 million or (12)% for the three months ended September 30, 2024, and increased by $13.7 million or 9%, for the nine months ended September 30, 2024, compared to the same period in the prior year. The decrease for thethree months ended September 30, 2024, compared to the same period in the prior year, was due primarily to lower manufacturing expenses. Theincrease for the nine months ended September 30, 2024, compared to the same period in the prior year, was primarily due to higher clinical trial expenses primarily related to the PRX012 and birtamimab programs and higher personnel expenses.

Previous wording

The following table sets forth the R&D expenses for our major programs (specifically, any active program with successful first dosing in a Phase 1 clinical trial), which were birtamimab, prasinezumab, NNC6019 (PRX004), BMS-986446 (PRX005), PRX012 and other R&D expenses for the three and six months ended June 30, 2024, and 2023, and the cumulative amounts to date (in thousands):

Current wording

The following table sets forth the R&D expenses for our major programs (specifically, any active program with successful first dosing in a Phase 1 clinical trial), which were birtamimab, prasinezumab, NNC6019 (PRX004), BMS-986446 (PRX005), PRX012 and other R&D expenses for the three and nine months ended September 30, 2024, and 2023, and the cumulative amounts to date (in thousands):

Previous wording

Our G&A expenses increased by $1.6 million or 11% for the three months ended June 30, 2024, and increased by $5.3 million, or 19%, for the six months ended June 30, 2024, compared to the same period in the prior year. The increase for thethree and six months ended June 30, 2024, compared to the prior year, was primarily due to higher personnel expenses and higher consulting expenses.

Current wording

Our G&A expenses increased by $0.1 million or 1% for the three months ended September 30, 2024, and increased by $5.5 million, or 12%, for the nine months ended September 30, 2024, compared to the same period in the prior year. The increase for the nine months ended September 30, 2024, compared to the prior year, was primarily due to higher personnel expenses.

Previous wording

Interest income decreased by $1.2 million or 15% for the three months ended June 30, 2024, anddecreased by $0.7 million, or 5%, for the six months ended June 30, 2024, compared to the same period in the prior year, primarily due to lower interest income from our cash and money market accounts resulting from lower cash balances.

Current wording

Interest income decreased by $1.8 million or 21% for the three months ended September 30, 2024, anddecreased by $2.5 million, or 11%, for the nine months ended September 30, 2024, compared to the same period in the prior year, primarily due to lower interest income from our cash and money market accounts resulting from lower cash balances.

Previous wording

Other expense, net for thethree and six months ended June 30, 2024, and 2023, was primarily foreign exchange losses from transactions with vendors denominated in Euros.

Current wording

Other expense, net for thethree and nine months ended September 30, 2024, and 2023, was primarily foreign exchange losses from transactions with vendors denominated in Euros.

Previous wording

The benefit from income taxes decreased by $2.3 million or 53% for thethree months ended June 30, 2024, and decreased by$3.0 million, or 41%, for the six months ended June 30, 2024, compared to the same period in the prior year. The decrease inbenefit from income taxes for thethree and six months ended June 30, 2024, compared to the same period in the prior year, was primarily due to a decrease in the net amount capitalized as deferred tax assets related to Section 174 R&D Capitalization.

Current wording

The benefit from income taxes decreased by $2.3 million or 73% for thethree months ended September 30, 2024, and decreased by $5.2 million, or 51%, for the nine months ended September 30, 2024, compared to the same period in the prior year. The decrease inbenefit from income taxes for thethree and nine months ended September 30, 2024, compared to the same period in the prior year, was primarily due to a decrease in the net amount capitalized as deferred tax assets related to Section 174 R&D Capitalization.

Previous wording

Working capital was $539.2 million as of June 30, 2024, a decrease of $43.2 million from working capital of$582.4 million as of December 31, 2023. This decrease in working capital during the six months ended June 30, 2024, was primarily attributable to cash use of $155.2 million for operating expenses (adjusted to exclude non-cash charges) offset in part by$80.0 million option exercise payment from BMS, net proceeds received from interest income on investments of $13.7 million and to a lesser extent, stock option exercises of approximately $1.5 million.

Current wording

Working capital was$488.6 million as of September 30, 2024, a decrease of $93.8 million from working capital of$582.4 million as of December 31, 2023. This decrease in working capital during the nine months ended September 30, 2024, was primarily attributable to cash use of$222.7 million for operating expenses (adjusted to exclude non-cash charges) offset in part by$80.0 million option exercise payment from BMS, net proceeds received from interest income on investments of$20.4 million and to a lesser extent, stock option exercises of approximately$1.9 million.

Previous wording

As of June 30, 2024, we had $564.1 million in cash and cash equivalents. Although we believe, based on our current business plans, that our existing cash and cash equivalents will be sufficient to meet our obligations for at least the next twelve months, we anticipate that we will require additional capital in the future in order to continue the research and development of our drug candidates. Additionally, in order to develop and obtain regulatory approval for our potential products we will need to raise substantial additional funds. We expect to raise any such additional funds through public or private equity or debt financings, colla borative agreements with corporate partners, or other arrangements, including pursuant to the Amended Distribution Agreement (See Note 8, “Shareholders’ Equity” to the Condensed Consolidated Financial Statements for more information). We cannot assume that such additional financings will be available on acceptable terms, if at all, and such financings may only be available on terms dilutive to our shareholders.

Current wording

As of September 30, 2024, we had$519.3 million in cash and cash equivalents. Although we believe, based on our current business plans, that our existing cash and cash equivalents will be sufficient to meet our obligations for at least the next twelve months, we anticipate that we will require additional capital in the future in order to continue the research and development of our drug candidates. Additionally, in order to develop and obtain regulatory approval for our potential products we will need to raise substantial additional funds. We expect to raise any such additional funds through public or private equity or debt financings, colla borative agreements with corporate partners, or other arrangements, including pursuant to the Amended Distribution Agreement (See Note 8, “Shareholders’ Equity” to the Condensed Consolidated Financial Statements for more information). We cannot assume that such additional financings will be available on acceptable terms, if at all, and such financings may only be available on terms dilutive to our shareholders.

Previous wording

In managing our liquidity needs in Ireland, we do not rely on unrepatriated earnings as a source of funds. As of June 30, 2024, $234.7 million of our outstanding cash and cash equivalents related to U.S. operations are considered permanently reinvested. We do not intend to repatriate these funds. However, if these funds were repatriated back to Ireland, we would incur a withholding tax from the dividend distribution.

Current wording

In managing our liquidity needs in Ireland, we do not rely on unrepatriated earnings as a source of funds. As of September 30, 2024, $255.0 million of our outstanding cash and cash equivalents related to U.S. operations are considered permanently reinvested. We do not intend to repatriate these funds. However, if these funds were repatriated back to Ireland, we would incur a withholding tax from the dividend distribution.

Previous wording

Because of the numerous risks and uncertainties associated with the development and commercialization of our product candidates, we are unable to estimate the amounts of increased capital outlays and operating expenses associated with completing the development of our product candidates. Our future capital requirements will depend on numerous factors, including, without limitation, the timing of initiation, progress, results and costs of our clinical trials; the results of our research and nonclinical studies; the costs of clinical manufacturing and of establishing commercial manufacturing arrangements; the costs of preparing, filing and prosecuting patent applications and maintaining, enforcing and defending intellectual property-related claims; the costs and timing of capital asset purchases; our ability to establish research collaborations, strategic collaborations, licensing or other arrangements; the costs to satisfy our obligations under current and potential future collaborations; the costs of any in-licensing transactions; and the timing, receipt, and amount of revenues or royalties, if any, from any approved drug candidates.

Current wording

The adequacy of our cash resources depends on many assumptions, including assumptions with respect to our expenses. These assumptions may prove to be wrong, and we could use our available capital resources sooner than we currently expect. Because of the numerous risks and uncertainties associated with the development and commercialization of our product candidates, we are unable to estimate the amounts of increased capital outlays and operating expenses associated with completing the development of our product candidates. Our future capital requirements will depend on numerous factors, including, without limitation, the timing of initiation, progress, results and costs of our clinical trials; the results of our research and nonclinical studies; the costs of clinical manufacturing and of establishing commercial manufacturing arrangements; the costs of preparing, filing and prosecuting patent applications and maintaining, enforcing and defending intellectual property-related claims; the costs and timing of capital asset purchases; our ability to establish research collaborations, strategic collaborations, licensing or other arrangements; the costs to satisfy our obligations under current and potential future collaborations; the costs of any in-licensing transactions; and the timing, receipt, and amount of revenues or royalties, if any, from any approved drug candidates.

Previous wording

Net cash used in operating activities was $57.1 million for the six months ended June 30, 2024, which was primarily due to ongoing research and development activities and general and administrative expenses to support those activities for a total of $155.2 million in operating expenses (adjusted to exclude non-cash charges of approximately $20.6 million), cash paid for accounts payable, accruals and other liabilities and prepaid expenses, partially offsetby proceeds received from interest income on investments of $13.7 million, cash from collection of accounts receivable and proceeds from stock option exercises of approximately $1.5 million.

Current wording

Net cash used in operating activities was $102.3 million for the nine months ended September 30, 2024, which was primarily due to ongoing research and development activities and general and administrative expenses to support those activities for a total of $222.7 million in operating expenses (adjusted to exclude non-cash charges of approximately $31.0 million), cash paid for accounts payable, accruals and other liabilities and prepaid expenses, partially offset by proceeds received from interest income on investments of $20.4 million, cash from collection of accounts receivable and proceeds from stock option exercises of approximately $1.9 million.

Previous wording

Net cash used in investing activities was$246,000 for thesix months ended June 30, 2024, which primarily consisted of expenditures to purchase property and equipment.

Current wording

Net cash used in investing activities was $255,000 for thenine months ended September 30, 2024, which primarily consisted of expenditures to purchase property and equipment.

Previous wording

Net cash provided by financing activities was $1.3 million for thesix months ended June 30, 2024, primarily from proceeds from issuances of ordinary shares upon exercises of stock options of $1.5 million.

Current wording

Net cash provided by financing activities was$1.6 million for thenine months ended September 30, 2024, primarily from proceeds from issuances of ordinary shares upon exercises of stock options of $1.9 million.

Previous wording

Refer to “Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations — Liquidity and Capital Resources” in our second quarter 2023 Quarterly Report on Form 10-Q for a discussion of the cash flows for the six months ended June 30, 2023.

Current wording

Refer to “Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations — Liquidity and Capital Resources” in our third quarter 2023 Quarterly Report on Form 10-Q for a discussion of the cash flows for the nine months ended September 30, 2023.

Previous wording

Our contractual obligations as of June 30, 2024, consisted of minimum cash payments under operating leases of $13.7 million, purchase obligations of $7.9 million (of which $3.6 million is included in current liabilities), and contractual obligations under license agreements of $0.3 million (of which nil is included in current liabilities). Purchase obligations consist of non-cancelable purchase commitments to suppliers. Operating leases represent our future minimum rental commitments under our non-cancelable operating leases. For additional information regarding the timing for our contractual obligations see Note 6, “Commitments and Contingencies” to Condensed Consolidated Financial Statements.

Current wording

Our contractual obligations as of September 30, 2024, consisted of minimum cash payments under operating leases of $12.9 million, purchase obligations of $8.0 million (of which $2.4 million is included in current liabilities), and contractual obligations under license agreements of $0.3 million (of which nil is included in current liabilities). Purchase obligations consist of non-cancelable purchase commitments to suppliers. Operating leases represent our future minimum rental commitments under our non-cancelable operating leases. For additional information regarding the timing for our contractual obligations see Note 6, “Commitments and Contingencies” to Condensed Consolidated Financial Statements.

Previous wording

In October 2022, we entered into a noncancelable operating sublease to lease approximately 31,157 square feet of office and laboratory space in Brisbane, California. We are obligated to make lease payments totaling approximately $14.9 million over the lease term, which expires on September 30, 2028, unless terminated earlier. Of this obligation, approximately$13.5 million remains outstanding as of June 30, 2024.

Current wording

In October 2022, we entered into a noncancelable operating sublease to lease approximately 31,157 square feet of office and laboratory space in Brisbane, California. We are obligated to make lease payments totaling approximately $14.9 million over the lease term, which expires on September 30, 2028, unless terminated earlier. Of this obligation, approximately$12.8 million remains outstanding as of September 30, 2024.

Previous wording

In addition to the contractual obligations above, we also expect to have future material cash requirements related to our clinical trials, discovery and pre-clinical programs, human capital and intellectual property. Assuming no significant change inour business, we expect the full year 2024 net cash used in operating and investing activities to be approximately $148 million to $160 million .

Current wording

In addition to the contractual obligations above, we also expect to have future material cash requirements related to ourclinical trials, discovery and pre-clinical programs, human capital and intellectual property. Assuming no significant change in our business, we expect the full year 2024 net cash used in operating and investing activities to be approximately $148 million to $160 million.
Rearranged current paragraphs (2)

Current report — wording carried from elsewhere

Collaboration revenue for the three and nine months ended September 30, 2023, included revenue from BMS for US Development Services related to the Tau/PRX005 program. As of September 30, 2024, the Company does not have any remaining Tau US Development Services Obligations and has recognized all revenue from this performance obligation as of December 31, 2023.

Current report — wording carried from elsewhere

As of September 30, 2024, the Company has $14.4 million of deferred revenue related to the remaining performance obligations under the PRX019 Global License Agreement related to PRX019 Phase 1 Clinical Trial Obligations. See Note 7, “Significant Agreements” to the Condensed Consolidated Financial Statements regarding the Collaboration Agreement with BMS for more information.
Rearranged previous paragraphs (3)

Previous report — wording carried elsewhere

10-Q, Part II Item 1A “Risk Factors” of this Quarterly Report on Form 10-Q, and in our other filings with the U.S. Securities and Exchange Commission.

Previous report — wording carried elsewhere

Assuming no significant change in our business, we expect our 2024 revenue to increase over the prior year.

Previous report — wording carried elsewhere

The adequacy of our cash resources depends on many assumptions, including assumptions with respect to our expenses. These assumptions may prove to be wrong, and we could use our available capital resources sooner than we currently expect.