Management’s Discussion and Analysis of Financial Condition and Results of Operations.
−Removed: You should read the following discussion and analysis of our financial condition and results of operations together with our condensed consolidated financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q and the audited financial information and the notes thereto included in our Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission (the "SEC") on February 7, 2023.
+Added: You should read the following discussion and analysis of our financial condition and results of operations together with our condensed consolidated financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q and the audited financial information and the notes thereto included in our Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission (the "SEC") on March 5, 2024.
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 and related financing, includes forward-looking statements that involve risks and uncertainties.
−Removed: As a result of many factors, including those factors set forth in the “Risk Factors” sections of our Annual Report on Form 10-K for the year ended December 31, 2022, our Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, our Quarterly Report on Form 10-Q for the quarter ended June 30, 2023 and this Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, 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.
+Added: As a result of many factors, including those factors set forth in the “Risk Factors” sections of our Annual Report on Form 10-K for the year ended December 31, 2023, 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 clinical-stage biopharmaceutical company translating insights from genetic epilepsies into the development of therapies for central nervous system, or CNS, disorders characterized by neuronal excitation-inhibition imbalance.
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Through this approach, we have established a diversified, multimodal CNS portfolio with four clinical-stage product candidates across movement disorders and epilepsy.
−Removed: For our most advanced product candidate under the Cerebrum™ platform, ulixacaltamide (also known as PRAX-944), topline results from the Phase 2b Essential1 clinical trial in essential tremor, or ET, were announced in the first quarter of 2023.
−Removed: We initiated our Phase 3 studies in ET in the fourth quarter of 2023, with enrollment expected to complete in the first half of 2024 and topline results expected in the second half of 2024.
−Removed: We initiated the PRAX-562 Phase 2 EMBOLD study in the first quarter of 2023 and expect to announce topline results in the first half of 2024.
−Removed: We also announced positive results from our PRAX-628 Phase 1 study in May 2023.
−Removed: In June 2023, we initiated a Phase 2 proof of concept study evaluating PRAX-628 in patients with a Photo Paroxysmal Response, or PPR, with results anticipated in the fourth quarter of 2023.
−Removed: Upon completion of the PPR study, we plan to initiate a Phase 2 study in focal epilepsy in the first half of 2024.
−Removed: For our most advanced product candidate under the Solidus™ platform, elsunersen (also known as PRAX-222), we completed dosing in the first cohort of the EMBRAVE study and announced preliminary data from the first dose cohort in October 2023.
+Added: For our most advanced product candidate under the Cerebrum™ platform, ulixacaltamide (formerly known as PRAX-944), we expect to announce topline results from the Phase 3 Essential3 clinical trials in essential tremor, or ET, in the second half of 2024.
+Added: Within our PRAX-628 program, we announced positive results from our Phase 2a Photo-Paroxysmal Response study in the first quarter of 2024 and plan to initiate the first of two efficacy studies of PRAX-628 in focal onset seizures in the second half of 2024, with topline results expected in 2025.
+Added: We plan to initiate a second PRAX-628 efficacy study in focal onset seizures in the first half of 2025, with topline results expected in the first half of 2026.
+Added: Our PRAX-562 Phase 2 EMBOLD study was initiated in the first quarter of 2023, with cohorts in SCN2A-DEE and SCN8A-DEE;
+Added: topline results are expected for both cohorts in the third quarter of 2024.
+Added: For our most advanced product candidate under the Solidus™ platform, elsunersen (formerly known as PRAX-222), we shared results from Part 1 of the EMBRAVE study in the fourth quarter of 2023, and are currently completing multiple global regulatory interactions in anticipation of starting the pivotal phase of the program later in 2024.
We were incorporated in 2015 and commenced operations in 2016.
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We are a development stage company and we have not generated any revenue from product sales, and do not expect to do so for several years, if at all.
−Removed: All of our product candidates are still in preclinical and clinical
−Removed: 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, if approved.
−Removed: We have incurred recurring operating losses since inception, including a net loss of $96.4 million for the nine months ended September 30, 2023.
−Removed: As of September 30, 2023, we had an accumulated deficit of $627.0 million.
+Added: All of our product candidates are still in preclinical and clinical development.
+Added: Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the
+Added: successful development and eventual commercialization of one or more of our product candidates, if approved.
+Added: We have incurred recurring operating losses since inception, including a net loss of $39.6 million for the three months ended March 31, 2024.
+Added: As of March 31, 2024, we had an accumulated deficit of $693.5 million.
We expect to incur significant expenses and operating losses for the foreseeable future as we expand our research and development activities.
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We anticipate that our expenses will be maintained or increased in connection with our ongoing activities, as we:
−Removed: • advance our lead product candidate, ulixacaltamide, to a late stage clinical trial for the treatment of ET;
+Added: • advance our lead product candidate, ulixacaltamide, through the Phase 3 Essential3 clinical trial program for ET;
• advance our PRAX-562 product candidate in the EMBOLD clinical trial;
−Removed: • advance our PRAX-222 product candidate in the EMBRAVE clinical trial;
−Removed: • advance our PRAX-628 product candidate;
+Added: • advance elsunersen (formerly PRAX-222) into the pivotal stage of the program;
+Added: • advance our PRAX-628 product candidate into efficacy clinical trials for focal onset seizures;
• advance our preclinical candidates to clinical trials;
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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.
−Removed: As of September 30, 2023, we had cash and cash equivalents of $101.1 million.
−Removed: We believe that our cash and cash equivalents as of September 30, 2023 will enable us to fund our operating expenses and capital expenditures into the first quarter of 2025.
−Removed: We have based this analysis on our current financial needs and ongoing research and development plans, which are limited to advancing product candidates through, but not beyond, their current clinical trials.
−Removed: We have based our assessment on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently expect.
+Added: As of March 31, 2024, we had cash, cash equivalents and marketable securities of $243.3 million.
+Added: We expect that our cash, cash equivalents, and marketable securities as of March 31, 2024, together with proceeds from our follow-on public offering in April 2024.
+Added: will be sufficient to fund our operating expenditures and capital expenditure requirements necessary to advance our research efforts and clinical trials into 2027.
+Added: The analysis included consideration of our current financial needs and ongoing research and development plans.
+Added: We have based this estimate on assumptions that may provide to be wrong, and we could exhaust our available capital resources sooner than we expect.
See “—Liquidity and Capital Resources.”
+Added: Reverse Stock Split
+Added: On November 28, 2023, we filed a Certificate of Amendment to our Amended and Restated Certificate of Incorporation with the Secretary of State of the State of Delaware to effect a 1-for-15 reverse stock split of our
+Added: common stock, or the Reverse Stock Split.
+Added: The Reverse Stock Split became effective at 5:00 p.m., Eastern Time, on November 28, 2023, or the Effective Time.
+Added: As a result of the Reverse Stock Split, every 15 shares of our issued and outstanding common stock were automatically reclassified into one validly issued, fully-paid and non-assessable share of common stock, subject to the treatment of fractional shares as described below, without any action on the part of the holders thereof.
+Added: The Reverse Stock Split did not affect the number of authorized shares of common stock or the par value of the common stock.
+Added: No fractional shares were issued in connection with the Reverse Stock Split.
+Added: Stockholders who would otherwise be entitled to receive fractional shares as a result of the Reverse Stock Split were entitled to a cash payment in lieu thereof at a price equal to the fraction to which the stockholder would otherwise be entitled, multiplied by the closing price per share of the common stock (as adjusted for the Reverse Stock Split) on the Nasdaq Global Select Market on November 28, 2023, the last trading day immediately preceding the Effective Time.
Financial Operations Overview
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As discussed in Note 7 to our condensed consolidated financial statements, we entered into an Option and License Agreement, or the Collaboration Agreement, with UCB Biopharma SRL, or UCB, in December 2022.
−Removed: We recognized $0.5 million and $1.9 million of collaboration revenue from the Collaboration Agreement during the three and nine months ended September 30, 2023, respectively.
+Added: We recognized $0.4 million of collaboration revenue from the Collaboration Agreement during the three months ended March 31, 2024.
Operating Expenses
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Research and development expenses represent costs incurred by us for the following:
−Removed: • costs to develop our IP portfolio;
• discovery efforts leading to development candidates;
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The capitalized amounts are expensed as the related goods are delivered or the services are performed.
−Removed: As a company operating in a virtual environment, a significant portion of our research and development costs have been external costs.
+Added: As a company operating in a virtual environment, a significant portion of our research and development costs have been external costs incurred by third-parties.
We track direct external research and development expenses to specific platforms and product candidates upon commencement.
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Three Months Ended
−Removed: September 30, Nine Months Ended
−Removed: September 30,
$ 12,785 $ 11,135
−Removed: $ 5,832 $ 16,293 $ 23,857 $ 76,720
−Removed: 2,806 3,655 16,330 13,883
Personnel-related (including stock-based compensation) 10,952 8,126
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A change in any of these variables with respect to the development of any of our product candidates would significantly change the costs, timing and viability associated with the development of that product candidate.
−Removed: For example, if the FDA or another regulatory authority were to delay our planned start of clinical trials or require us to conduct clinical trials or other testing beyond those that we currently expect, or if we experience significant delays in
−Removed: enrollment in any of our planned clinical trials, we could be required to expend significant additional financial resources and time to complete our clinical development activities.
+Added: For example, if the FDA or another regulatory authority were to delay our planned start of clinical trials or require us to conduct clinical trials or other testing beyond those that we currently expect, or if we experience significant delays in enrollment in any of our planned clinical trials, we could be required to expend significant additional financial resources and time to complete our clinical development activities.
We may never obtain regulatory approval for any of our product candidates.
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Our income tax provision may be significantly affected by changes to our estimates.
−Removed: There was no income tax provision recognized for the three and nine months ended September 30, 2023 and 2022.
+Added: There was no income tax provision recognized for the three months ended March 31, 2024 and 2023.
Results of Operations
−Removed: Comparison of the Three Months Ended September 30, 2023 and 2022
+Added: Comparison of the Three Months Ended March 31, 2024 and 2023
The following table summarizes our condensed consolidated statements of operations for each period presented (in thousands):
Three Months Ended
−Removed: September 30, Change
+Added: March 31, Change
Collaboration revenue $ 431 $ 683 $ (252)
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Collaboration Revenue
−Removed: The $0.5 million increase in collaboration revenue is associated with the revenue recorded as research services are provided and costs are incurred under the Collaboration Agreement with UCB that was executed in December 2022.
+Added: The $0.3 million decrease in collaboration revenue is associated with a decrease in the revenue recorded under the Collaboration Agreement with UCB that was executed in December 2022.
+Added: Changes in revenue recognized each period reflect timing of research services provided and costs incurred.
Research and Development Expense
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Three Months Ended
−Removed: September 30, Change
−Removed: $ 5,832 $ 16,293 $ (10,461)
−Removed: 2,806 3,655 (849)
−Removed: Personnel-related (including stock-based compensation) 6,840 8,714 (1,874)
−Removed: Other indirect research and development expenses 1,782 1,777 5
−Removed: Total research and development expenses $ 17,260 $ 30,439 $ (13,179)
−Removed: The $13.2 million decrease in research and development expenses was primarily attributable to the following:
−Removed: • $10.5 million decrease in expense related to our Cerebrum™ platform, driven primarily by:
−Removed: ◦ $4.2 million decrease in spend for our ulixacaltamide program, primarily due to prior year Phase 1 spending and decreased activity related to our Essential1 study, partially offset by costs related to Essential3 study start up activities;
−Removed: ◦ $2.9 million decrease in clinical-related spend for our PRAX-114 program due to our strategic realignment in the second quarter of 2022;
−Removed: ◦ $1.4 million decrease in spend for our PRAX-562 program, primarily related to prior year manufacturing spend and Phase 1 trial spend, partially offset by current quarter costs related to the EMBOLD Phase 2 clinical trial;
−Removed: ◦ $1.4 million decrease in activities for our earlier stage assets;
−Removed: ◦ $0.6 million decrease in clinical-related spend for our PRAX-628 Phase 1 clinical trial.
−Removed: • $0.8 million decrease in expense related to our Solidus™ platform, primarily related to prior year PRAX-222 toxicology spend and clinical study spend, partially offset by current quarter spend for our EMBRAVE Phase 2 clinical trial;
−Removed: • $1.9 million decrease in personnel-related costs due to decreased headcount.
−Removed: General and Administrative Expense
−Removed: The $5.1 million decrease in general and administrative expenses was primarily attributable to the following:
−Removed: • $2.5 million decrease in personnel costs due to decreased headcount;
−Removed: • $1.9 million decrease in consulting expenses and professional fees, and
−Removed: • $0.7 million decrease in other general and administrative expenses.
−Removed: Other income for the three months ended September 30, 2023 was comprised of interest income on our cash and cash equivalents.
−Removed: Other income for the three months ended September 30, 2022 was comprised of interest income on our cash, cash equivalents and marketable securities and investment premium and discount amortization.
−Removed: Comparison of the Nine Months Ended September 30, 2023 and 2022
−Removed: The following table summarizes our condensed consolidated statements of operations for each period presented (in thousands):
−Removed: Nine Months Ended
−Removed: September 30, Change
−Removed: Collaboration revenue $ 1,932 $ — $ 1,932
−Removed: Operating expenses:
−Removed: Research and development 68,378 126,711 (58,333)
−Removed: General and administrative 32,121 46,822 (14,701)
−Removed: Total operating expenses 100,499 173,533 (73,034)
−Removed: Loss from operations (98,567) (173,533) 74,966
−Removed: Other income:
−Removed: Other income, net 2,168 677 1,491
−Removed: Total other income 2,168 677 1,491
−Removed: Net loss $ (96,399) $ (172,856) $ 76,457
−Removed: Collaboration Revenue
−Removed: The $1.9 million increase in collaboration revenue is associated with the revenue recorded as research services are provided and costs are incurred under the Collaboration Agreement with UCB that was executed in December 2022.
−Removed: Research and Development Expense
−Removed: The following table summarizes our research and development expenses for each period presented, along with the changes in those items (in thousands):
−Removed: Nine Months Ended
−Removed: September 30, Change
+Added: March 31, Change
$ 12,785 $ 11,135 $ 1,650
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Total research and development expenses $ 26,984 $ 25,504 $ 1,480
−Removed: The $58.3 million decrease in research and development expenses was primarily attributable to the following:
−Removed: • $52.9 million decrease in expense related to our Cerebrum™ platform, driven primarily by:
−Removed: ◦ $29.0 million decrease in clinical-related spend for our PRAX-114 program due to our strategic realignment in the second quarter of 2022;
−Removed: ◦ $11.6 million decrease in spend for our PRAX-562 program primarily related to prior year manufacturing spend and Phase 1 trial spending, partially offset by costs for our EMBOLD Phase 2 clinical trial in 2023;
−Removed: ◦ $9.1 million decrease in spend for our ulixacaltamide program, primarily due to prior year Phase 2a and Phase 1 trial spend, prior year manufacturing costs and decreased spend in the current year related to our Essential1 trial, partially offset by startup costs related to our Essential3 study;
−Removed: ◦ $5.4 million decrease in activities for our earlier stage assets due to prioritization of our clinical-stage programs;
−Removed: ◦ $2.2 million increase in clinical-related spend for our PRAX-628 program driven by our Phase 1 clinical trial and our Phase 2 PPR clinical trial.
−Removed: • $8.8 million decrease in personnel-related costs due to decreased headcount;
−Removed: • $2.4 million increase in expense related to our Solidus™ platform, primarily driven by costs associated with the initiation of the PRAX-222 EMBRAVE study in 2023 and associated milestone payment earned by Ionis Pharmaceuticals, Inc., or Ionis, partially offset by manufacturing expenses incurred in the prior year and a $2.0 million license fee earned by Ionis in 2022;
−Removed: • $0.9 million increase in indirect expenses, none of which were individually significant.
+Added: The $1.5 million increase in research and development expenses was primarily attributable to the following:
+Added: • $2.8 million increase in personnel-related costs, primarily due to increased stock-based compensation expense;
+Added: • $1.7 million increase in expense related to our Cerebrum™ platform, driven primarily by:
+Added: ◦ a $5.2 million increase in spend for our ulixacaltamide program due to Essential3 study activity;
+Added: ◦ a $1.6 million decrease in spend for our PRAX-628 program due to prior year clinical-related spend;
+Added: ◦ a $1.0 million decrease in activities for our earlier stage assets due to prioritization of clinical-stage programs;
+Added: ◦ a $0.7 million decrease in spend for our PRAX-562 program.
+Added: • $2.4 million decrease in expense related to our Solidus™ platform, primarily related to prior year toxicology and clinical pharmacology spend for elsunersen;
+Added: • $0.6 million decrease in indirect expenses, none of which were individually significant.
General and Administrative Expense
−Removed: The $14.7 million decrease in general and administrative expenses was primarily attributable to the following:
−Removed: • $6.8 million decrease in professional fees and consulting expenses;
−Removed: • $5.6 million decrease in personnel-related costs due to decreased headcount;
−Removed: • $2.3 million decrease in other general and administrative expenses.
−Removed: Other income for the nine months ended September 30, 2023 and 2022 was comprised of interest income on our cash, cash equivalents and marketable securities and investment premium and discount amortization.
+Added: The $2.0 million increase in general and administrative expenses was primarily attributable to the following:
+Added: • $2.9 million increase in personnel-related costs mainly due to increased stock-based compensation expense;
+Added: • $0.9 million decrease in consulting expenses and professional fees.
+Added: Other income for the three months ended March 31, 2024 and 2023 was comprised of interest income on our cash, cash equivalents, and marketable securities and investment premium and discount amortization.
Liquidity and Capital Resources
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We have not yet commercialized any of our product candidates, which are in various phases of preclinical and clinical development, and we do not expect to generate revenue from sales of any products for several years, if at all.
−Removed: To date, we have financed our operations primarily with proceeds from the issuance of redeemable convertible preferred stock and from the sale of common stock through an initial public offering, follow-on public offerings and at-the-market offerings under our shelf registration statement.
−Removed: From inception through September 30, 2023, we have raised $613.6 million in aggregate cash proceeds from such transactions, net of issuance costs.
−Removed: As of September 30, 2023, we had cash and cash equivalents of $101.1 million.
+Added: To date, we have financed our operations primarily with proceeds from the issuance of redeemable convertible preferred stock and from the sale of common stock through an initial public offering, common stock and pre-funded warrants through follow-on public offerings and common stock from at-the-market offerings under our shelf registration statement.
+Added: From inception through March 31, 2024, we have raised $785.3 million in aggregate cash proceeds from such transactions, net of issuance costs.
+Added: As of March 31, 2024, we had cash and cash equivalents and marketable securities of $243.3 million.
In November 2021, we entered into an Open Market Sale Agreement, or the 2021 Sales Agreement, with Jefferies LLC, or Jefferies, to provide for the offering, issuance and sale of up to an aggregate amount of $125.0 million of common stock from time to time in at-the-market offerings for which Jefferies acted as sales agent.
We terminated the 2021 Sales Agreement in June 2023.
−Removed: During the nine months ended September 30, 2023, we issued and sold 14,291,937 shares under the sales agreement for aggregate net proceeds of $24.1 million.
−Removed: We issued and sold a total of 18,279,207 shares under the Sales Agreement for aggregate net proceeds of $40.7 million after deducting commissions and offering expenses payable by us.
On June 21, 2023, we completed a public offering of:
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Total net proceeds generated from the offering were approximately $63.4 million, after deducting underwriting discounts, commissions and other offering expenses payable by us.
+Added: In December 2023, we entered into an Open Market Sale Agreement, or the 2023 Sales Agreement, with Jefferies, to provide for the offering, issuance and sale of up to an aggregate amount of $75.0 million of common stock in at-the-market offerings.
+Added: The 2023 Sales Agreement was terminated in January 2024.
+Added: During the three months ended March 31, 2024, we issued and sold an aggregate of 192,190 shares under the 2023 Sales Agreement for aggregate net proceeds of $5.3 million, after deducting commissions and offering expenses payable by us.
+Added: On January 16, 2024, we completed a public offering of:
+Added: (i) an aggregate of 3,802,025 shares of our common stock at a public offering price of $35.50 per share, including the underwriters' full exercise of their option to purchase 633,750 additional shares of common stock, and (ii) pre-funded warrants to purchase 1,056,725 shares of common stock at a public offering price of $35.4999 per share of common stock underlying the warrants.
+Added: The purchase price per share of each pre-funded warrant represents the per share offering price for the common stock, less the $0.0001 per share exercise price of each underlying share.
+Added: Total net proceeds generated from the offering were approximately $161.6 million, after deducting underwriting discounts, commissions and other offering expenses payable by us.
+Added: In March 2024, we entered into an Open Market Sale Agreement, or the 2024 Sales Agreement, with Jefferies, to provide for the offering, issuance, and sale of up to an aggregate amount of $150.0 million of common stock in at-the-market offerings.
+Added: During the three months ended March 31, 2024, we issued and sold an aggregate of 17,662 shares under the 2024 Sales Agreement for aggregate net proceeds of $0.9 million, after deducting commissions and offering expenses payable by us.
+Added: On April 2, 2024, we completed a public offering of:
+Added: (i) an aggregate of 3,849,558 shares of our common stock at a public offering price of $56.50 per share, including the underwriters' full exercise of their option to purchase 530,973 additional shares of common stock, and (ii) pre-funded warrants to purchase 221,238 shares of common stock at a public offering price of $56.4999 per share of common stock underlying the warrants.
+Added: The purchase price per share for each pre-funded warrant represents the per share offering price for the common stock, less the $0.0001 per share exercise price of each underlying share.
+Added: Total net proceeds generated from the offering were approximately $215.8 million, after deducting underwriting discounts, commissions and other offering expenses payable by us.
The following table provides information regarding our cash flows for each period presented (in thousands):
−Removed: Nine Months Ended
−Removed: September 30,
+Added: Three Months Ended
Net cash (used in) provided by:
2 unchanged sentences
Financing activities 182,757 18,070
−Removed: Net increase (decrease) in cash, cash equivalents and restricted cash $ 39,470 $ (76,864)
+Added: Net increase in cash, cash equivalents and restricted cash $ 70,680 $ 19,224
Operating Activities
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The cash used in operating activities resulted primarily from our net losses adjusted for non-cash charges and changes in operating assets and liabilities, which are primarily the result of increased expenses and timing of vendor payments.
−Removed: During the nine months ended September 30, 2023, net cash used in operating activities of $87.3 million was primarily due to our $96.4 million net loss and $11.0 million in changes in operating assets and liabilities primarily related to decreases in accrued expenses and accounts payable, partially offset by $20.1 million of non-cash charges primarily related to stock-based compensation.
−Removed: During the nine months ended September 30, 2022, net cash used in operating activities of $156.2 million was primarily due to our $172.9 million net loss and $7.3 million in changes in operating assets and liabilities primarily related to a decrease in accrued expenses, partially offset by $23.9 million of non-cash charges primarily related to stock-based compensation.
+Added: During the three months ended March 31, 2024, net cash used in operating activities of $20.9 million was primarily due to our $39.6 million net loss, partially offset by $1.5 million in changes in operating assets and liabilities primarily related to an increase in accounts payable and $17.2 million of non-cash charges primarily related to stock-based compensation.
+Added: During the three months ended March 31, 2023, net cash used in operating activities of $32.8 million was primarily due to our $37.5 million net loss and $3.3 million in changes in operating assets and liabilities primarily related to a decrease in accrued expenses, partially offset by $7.9 million of non-cash charges primarily related to stock-based compensation.
Investing Activities
−Removed: During the nine months ended September 30, 2023, net cash provided by investing activities of $39.0 million was primarily related to maturities of marketable securities.
−Removed: During the nine months ended September 30, 2022, net cash provided by investing activities of $74.3 million was primarily related to maturities of marketable securities, partially offset by purchases of marketable securities.
+Added: During the three months ended March 31, 2024, net cash used in investing activities of $91.2 million was related to purchases of marketable securities.
+Added: During the three months ended March 31, 2023, net cash provided by investing activities of $34.0 million was related to maturities of marketable securities.
Financing Activities
−Removed: During the nine months ended September 30, 2023, net cash provided by financing activities of $87.7 million consisted primarily of net proceeds from at-the-market offerings and our June 2023 follow-on public offering.
−Removed: During the nine months ended September 30, 2022, net cash provided by financing activities of $5.1 million consisted of net proceeds from at-the-market offerings of $4.3 million and proceeds from purchases of common stock under our employee stock purchase plan and from the exercise of stock options, partially offset by the payment of issuance costs for our at-the-market offerings and the payment of taxes related to the vesting of restricted stock units.
+Added: During the three months ended March 31, 2024, net cash provided by financing activities of $182.8 million consisted primarily of net proceeds from our January 2024 follow-on public offering, our at-the-market offerings and our collaboration and license agreement with Tenacia.
+Added: During the three months ended March 31, 2023, net cash provided by financing activities of $18.1 million consisted of net proceeds from at-the-market offerings.
Plan of Operation and Future Funding Requirements
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• experience any delays or encounter any issues with any of the above, including but not limited to failed studies, complex results, safety issues or other regulatory challenges.
−Removed: We are unable to estimate the exact amount of our working capital requirements, but based on our current operating plan, we believe that our cash and cash equivalents as of September 30, 2023 will enable us to fund our operating expenses and capital expenditure requirements into the first quarter of 2025.
+Added: We are unable to estimate the exact amount of our working capital requirements, but based on our current operating plan, we believe that our cash, cash equivalents, and marketable securities as of March 31, 2024, together with proceeds from our April 2024 public offering, will be sufficient to fund our operating expenses and capital expenditure requirements into 2027.
However, we have based this estimate on assumptions that may prove to be wrong and we could exhaust our capital resources sooner than we expect.
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In addition, our product candidates, if approved, may not achieve commercial success.
−Removed: Our commercial revenues, if any, will be derived
−Removed: from sales of products that we do not expect to be commercially available for many years, if ever.
+Added: Our commercial revenues, if any, will be derived from sales of products that we do not expect to be commercially available for many years, if ever.
Accordingly, we will need to obtain substantial additional funds to achieve our business objectives.
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Actual results may differ from these estimates under different assumptions or conditions.
−Removed: There have been no changes to our critical accounting policies from those described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Critical Accounting Policies and Significant Judgments and Estimates” included in our Annual Report on Form 10-K filed with the SEC on February 7, 2023, other than as disclosed in Note 2 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q.
+Added: There have been no changes to our critical accounting policies from those described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Critical Accounting Policies and Significant Judgments and Estimates” included in our Annual Report on Form 10-K filed with the SEC on March 5, 2024, other than as disclosed in Note 2 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q.
Recently Issued Accounting Pronouncements
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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.