Entrada Therapeutics Inc
For the period ended Sep 30, 2024. Filed Nov 5, 2024.
View on SEC.govAbout 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 5, 2024
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-06-30; filed 2024-08-13.
0001689375-24-000047
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-09-30; filed 2024-11-05.
0001689375-24-000063
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe 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 143 previous paragraphs and 143 current paragraphs.
103 unchanged; 37 reworded; 2 added; 2 removed; 1 previous and 1 current paragraphs rearranged.
Tables are not compared: 5 previous and 5 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
Collaboration revenue was $19.6 million for the three months ended September 30, 2024 and $43.7 million for the three months ended September 30, 2023. The decrease was primarily driven by fewer costs incurred for VX-670 research activities during the three months ended September 30, 2024 as compared to the three months ended September 30, 2023.
Current report
Comparison of thenine months ended September 30, 2024 and 2023
Removed paragraphs (2)
Previous report
•the effects of worldwide pandemics and health crises.
Previous report
Comparison of thesix months ended June 30, 2024 and 2023
Reworded paragraphs (37)
Previous wording
We are a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines which engage intracellular targets that have long been considered inaccessible. The Company’s Endosomal Escape Vehicle ("EEV™")-therapeutics are designed to enable the efficient delivery of a wide range of therapeutics into a variety of organs and tissues, resulting in an improved therapeutic index. Through our proprietary, highly versatile and modular EEV platform ("EEV Platform"), we are building a robust development portfolio of therapeutic candidates. Our first two drug candidates, ENTR-601-44 and our partnered candidate, VX-670, are in clinical trials, and we expect to initiate additional regulatory filings by the end of 2024. We believe that the potential success of our early programs can translate into the efficient development of additional EEV therapeutic candidates and allow us to build portfolios in neuromuscular disease and beyond.
Current wording
We are a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines which engage intracellular targets that have long been considered inaccessible. The Company’s Endosomal Escape Vehicle ("EEV™")-therapeutics are designed to enable the efficient delivery of a wide range of therapeutics into a variety of organs and tissues, resulting in an improved therapeutic index. Through our proprietary, highly versatile and modular EEV platform ("EEV Platform"), we are building a robust development portfolio of therapeutic candidates. On June 24, 2024, we reported positive preliminary data in healthy volunteers from a Phase 1 clinical trial, ENTR-601-44-101, for our first drug candidate. Our Vertex partnered candidate, VX-670, is in an ongoing global Phase 1/2 clinical trial and announced in November 2024 completion of the Phase 1 SAD portion of the study and initiation of the Phase 2 MAD portion to evaluate both safety and efficacy. We expect to initiate additional regulatory filings by the end of 2024. We believe that the potential success of our early programs can translate into the efficient development of additional therapeutic candidates and allow us to build portfolios in neuromuscular disease and beyond.
Previous wording
We are initially focused on the development of EEV therapeutics for rare neuromuscular diseases, starting with Duchenne muscular dystrophy ("Duchenne" or "DMD"). DMD is caused by genetic mutations that prevent the creation of functional dystrophin, a protein required to maintain the structural integrity of muscle cells. In our neuromuscular disease programs, we link EEVs to small strands of nucleic acids called oligonucleotides, including phosphorodiamidate morpholino oligomers ("PMOs"). We are developing EEV-PMOs that promote the skipping of these mutations associated with DMD. We believe that our EEV-PMO exon-skipping therapy will enable the production of functional dystrophin to slow, stop or even reverse disease progression. Our most advanced therapeutic candidate, ENTR-601-44, is being developed for patients with DMD that are exon 44 skipping amenable.
Current wording
We are initially focused on the development of EEV therapeutics for rare neuromuscular diseases, starting with Duchenne muscular dystrophy ("Duchenne" or "DMD"). DMD is caused by genetic mutations that prevent the creation of functional dystrophin, a protein required to maintain the structural integrity of muscle cells. In our neuromuscular disease programs, we link EEVs to small strands of nucleic acids called oligonucleotides, including phosphorodiamidate morpholino oligomers ("PMOs"). We are developing EEV-PMOs that promote the skipping of these DMD-associated mutations. Based on preclinical and clinical data observed to date, we believe that our EEV-PMO exon-skipping therapy will enable the production of functional dystrophin to slow, stop or even reverse disease progression. Our most advanced therapeutic candidate, ENTR-601-44, is being developed for patients with DMD that are exon 44 skipping amenable.
Previous wording
The primary objective of the Phase 1 clinical trial was to evaluate the safety and tolerability of a single dose of ENTR-601-44. The trial also evaluated pharmacokinetics and target engagement, as measured by exon skipping in the skeletal muscle. The trial included a total of 32 healthy male volunteers across four cohorts, with each cohort consisting of six participants receiving ENTR-601-44 and two participants receiving a placebo control. The doses administered across the cohorts were 0.75 mg/kg, 1.5 mg/kg, 3 mg/kg and 6 mg/kg.
Current wording
The trial included a total of 32 healthy male volunteers across four cohorts, with each cohort consisting of six participants receiving ENTR-601-44 and two participants receiving a placebo control. The doses administered across the cohorts were 0.75 mg/kg, 1.5 mg/kg, 3 mg/kg and 6 mg/kg.
Previous wording
There were no serious adverse events, no drug-related adverse events and no clinically significant changes or trends noted in vital signs, electrocardiograms, physical exams or laboratory assessments observed in the trial. The study demonstrated target engagement as measured by exon skipping on a ng/g of tissue adjusted basis supporting the importance of endosomal escape to therapeutic index optimization. Muscle concentration was detected in all six subjects in the 6 mg/kg dose cohort (mean of 53.8 ng/g, range 40 ng/g-73.5 ng/g) and mean target engagement as measured by exon skipping was 0.44% (range 0.3-0.65%). Exon skipping was statistically significant compared to the placebo control (p<0.005) in the 6 mg/kg dose cohort. These results are based upon data collected to date and are aggregated based upon the placebo and study drug groups. Data will be featured in a poster presentation at the 29th Annual Congress of the World Muscle Society, taking place in Prague, Czechia from October 8-12, 2024.
Current wording
There were no serious adverse events, no drug-related adverse events and no clinically significant changes or trends noted in vital signs, electrocardiograms, physical exams or laboratory assessments observed in the trial. The study demonstrated target engagement as measured by exon skipping on a ng/g of tissue adjusted basis supporting the importance of endosomal escape to therapeutic index optimization. Muscle concentration was detected in all six subjects in the 6 mg/kg dose cohort (mean of 53.8 ng/g, range 40 ng/g-73.5 ng/g) and mean target engagement as measured by exon skipping was 0.44% (range 0.3-0.65%). Exon skipping was statistically significant compared to the placebo control (p<0.005) in the 6 mg/kg dose cohort.
Previous wording
Based on the positive data from the Phase 1 clinical trial, the Company is on track to submit regulatory applications in the fourth quarter of 2024 to initiate separate global Phase 2 clinical trials for ENTR-601-44 in patients with Duchenne who are exon 44 skipping amenable and for ENTR-601-45 in patients with Duchenne who are exon 45 skipping amenable, subject to regulatory feedback. In addition, we plan to submit regulatory applications in 2025 to initiate a global Phase 2 clinical trial for our third Duchenne candidate, ENTR-601-50, in patients who are exon 50 skipping amenable, subject to regulatory feedback.
Current wording
Based on positive preclinical data and data from the Phase 1 clinical trial, the Company is on track to submit regulatory applications in the fourth quarter of 2024 to initiate separate global Phase 2 clinical trials for ENTR-601-44 in patients with Duchenne who are exon 44 skipping amenable and for ENTR-601-45 in patients with Duchenne who are exon 45 skipping amenable, subject to regulatory feedback. In addition, we plan to submit regulatory applications in 2025 to initiate a global Phase 2 clinical trial for our third Duchenne candidate, ENTR-601-50, in patients who are exon 50 skipping amenable, subject to regulatory feedback.
Previous wording
•ENTR-601-45: Expect to submit Clinical Trial Application ("CTA")/IND in Q4 2024
Current wording
•ENTR-601-45: Expect to submit Phase 2 regulatory submissions in Q4 2024
Previous wording
•ENTR-601-50: Expect to submit CTA/IND in 2025
Current wording
•ENTR-601-50: Expect to submit Phase 2 regulatory submissions in 2025
Previous wording
Under the terms of the Vertex Agreement, we initially received $250.0 million from the Vertex Agreement comprised of an upfront payment of $223.7 million and an equity investment of $26.3 million in our common stock at $16.26 per share. In October 2023, we achieved a milestone pursuant to the Vertex Agreement related to preclinical IND-enabling Good Laboratory Practices ("GLP") toxicology studies of VX-670 that triggered a $17.5 million milestone payment, which we received in the fourth quarter of 2023. In the first quarter of 2024, we achieved a milestone related to the clinical advancement of VX-670, which triggered a $75.0 million payment. We received this payment in the second quarter of 2024.
Current wording
Under the terms of the Vertex Agreement, we initially received $250.0 million from the Vertex Agreement comprised of an upfront payment of $223.7 million and an equity investment of $26.3 million in our common stock at $16.26 per share. In the fourth quarter of 2023, we achieved a milestone pursuant to the Vertex Agreement related to preclinical IND-enabling Good Laboratory Practices ("GLP") toxicology studies of VX-670 that triggered a $17.5 million milestone payment, which we received in the fourth quarter of 2023. In the first quarter of 2024, we achieved a milestone related to the clinical advancement of VX-670, which triggered a $75.0 million payment. We received this payment in the second quarter of 2024.
Previous wording
On May 6, 2024, Vertex announced that its IND for the Phase 1/2 clinical trial of VX-670 in people with DM1 has cleared, as have the CTAs in Canada, the United Kingdom and the European Union, and the Clinical Trials Notification ("CTN") in Australia. On August 1, 2024, Vertex announced that they continue to enroll and dose patients in the global Phase 1/2 clinical trial for VX-670 in people with DM1 and expect to complete the single ascending dose (SAD) portion of the study by the end of 2024. Following completion of the SAD portion of the trial, Vertex will move into the multiple ascending dose portion, where both the safety and efficacy of VX-670 will be evaluated.
Current wording
On May 6, 2024, Vertex announced that its IND for the Phase 1/2 clinical trial of VX-670 in people with DM1 has cleared, as have the CTAs in Canada, the United Kingdom and the European Union, and the Clinical Trials Notification ("CTN") in Australia. On November 4, 2024 Vertex announced completion of the single ascending dose (SAD) portion of the global Phase 1/2 clinical trial for VX-670 in people with DM1. In addition Vertex announced that they have initiated the MAD portion of the Phase 1/2 study, in which both the safety and efficacy of VX-670 will be evaluated.
Previous wording
Since our inception, we have devoted substantially all our resources to research and development efforts relating to our EEV Platform, advancing development of our portfolio of programs and general and administrative support for these operations, including raising capital. Since our inception, we have raised over $850.0 million of gross proceeds from equity sales to leading biotechnology investors and from the Vertex Agreement.
Current wording
Since our inception, we have devoted substantially all our resources to research and development efforts relating to our EEV Platform, advancing development of our portfolio of programs and general and administrative support for these operations, including raising capital. We have raised over $850.0 million of gross proceeds from equity sales to leading biotechnology investors and from the Vertex Agreement.
Previous wording
Since inception, we have incurred significant net losses. As of June 30, 2024, we had an accumulated deficit of $116.4 million. Other than the recognition of revenue related to collaboration payments, we expect to continue to generate operating losses and negative operating cash flows for the foreseeable future as we advance our platform and EEV therapeutic candidates. We will not generate any revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for one or more therapeutic candidates, if ever. If we obtain regulatory approval for any therapeutic candidates, we expect to incur significant expenses related to developing our internal commercialization capability to support product sales, marketing and distribution.
Current wording
Since inception, we have incurred significant net losses. As of September 30, 2024, we had an accumulated deficit of $130.5 million. Other than the recognition of revenue related to collaboration payments, we expect to continue to generate operating losses and negative operating cash flows for the foreseeable future as we advance our platform and therapeutic candidates. We will not generate any revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for one or more therapeutic candidates, if ever. If we obtain regulatory approval for any therapeutic candidates, we expect to incur significant expenses related to developing our internal commercialization capability to support product sales, marketing and distribution.
Previous wording
As of June 30, 2024, we had cash, cash equivalents and marketable securities of $469.7 million. Based on our current operating plans, we believe that our cash, cash equivalents and marketable securities as of June 30, 2024 will be sufficient to fund our operations into 2027. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. See “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources.” To finance our operations beyond that point we will need to raise additional capital, which cannot be assured.
Current wording
As of September 30, 2024, we had cash, cash equivalents and marketable securities of $449.3 million. Based on our current operating plans, we believe that our cash, cash equivalents and marketable securities as of September 30, 2024 will be sufficient to fund our operations into 2027. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. See “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources.” To finance our operations beyond that point we will need to raise additional capital, which cannot be assured.
Previous wording
•obtaining, maintaining, protecting and enforcing patent and trade secret protection and regulatory exclusivity for our therapeutic candidates;
Current wording
•obtaining, maintaining, protecting and enforcing patent and trade secret protection and regulatory exclusivity for our therapeutic candidates; and
Previous wording
•obtaining and maintaining adequate coverage and reimbursement from third party payors; and
Current wording
•obtaining and maintaining adequate coverage and reimbursement from third party payors.
Previous wording
Research and development expenses were $32.0 million for the three months ended June 30, 2024, compared to $26.3 million for the three months ended June 30, 2023. The increase of $5.7 million in research and development expenses was primarily attributable to:
Current wording
Research and development expenses were $31.3 million for the three months ended September 30, 2024, compared to $22.2 million for the three months ended September 30, 2023. The increase of $9.1 million in research and development expenses was primarily attributable to:
Previous wording
•an increase of $3.1 million in external costs primarily driven by additional research activities performed for VX-670 and additional preclinical costs incurred related to ENTR-601-50 and additional investments into our discovery programs. These increases were slightly offset by lower costs incurred related to ENTR-601-44 and ENTR-601-45; and
Current wording
•an increase of $4.6 million in external costs primarily driven by additional research and development activities performed for ENTR-601-44, ENTR-601-45, and ENTR-60-50; and
Previous wording
•an increase of $2.6 million in internal costs driven by increased headcount in our research and development function, inclusive of stock-based compensation expense of $2.0 million and $1.4 million for the three months ended June 30, 2024 and 2023, respectively, and increased facilities costs to support our expanding operations.
Current wording
•an increase of $4.5 million in internal costs driven by increased headcount in our research and development function, inclusive of stock-based compensation expense of $2.1 million and $1.6 million for the three months ended September 30, 2024 and 2023, respectively.
Previous wording
We expect that our research and development expenses will increase as we advance ENTR-601-44 / ENTR-601-45 through clinical trials, and ENTR-601-50 through preclinical development and into clinical trials, support our partnered candidate, VX-670, and continue to perform discovery work for future product candidates.
Current wording
We expect that our research and development expenses will increase as we advance ENTR-601-44 / ENTR-601-45 through clinical trials, and ENTR-601-50 through preclinical development and into clinical trials, perform research activities under the Vertex Agreement and continue to perform discovery work for future product candidates.
Previous wording
General and administrative expenses for the three months ended June 30, 2024 were $9.2 million, compared to $8.2 million for the three months ended June 30, 2023. The increase of $1.0 million was primarily attributable to an increase in personnel costs as the headcount in our general and administrative function increased. Our general and administrative personnel costs are inclusive of stock-based compensation expense of $2.6 million and$1.7 million for the three months ended June 30, 2024 and 2023, respectively.
Current wording
General and administrative expenses for the three months ended September 30, 2024 were $10.0 million, compared to $7.5 million for the three months ended September 30, 2023. The increase of $2.5 million was primarily attributable to an increase in personnel costs as the headcount in our general and administrative function increased. Our general and administrative personnel costs are inclusive of stock-based compensation expense of $2.7 million and$1.8 millionfor the three months ended September 30, 2024 and 2023, respectively.
Previous wording
Total interest and other income, net was$8.6 million for thesix months ended June 30, 2024, compared to$6.9 million of interest and other income for thesix months ended June 30, 2023; this increase is primarily driven by higher interest income from investments in debt securities due to an overall increase in interest rates and also an increase in the amount of debt securities held.
Current wording
Total interest and other income, net was$5.8 million for thethree months ended September 30, 2024, compared to$4.1 million of interest and other income for thethree months ended September 30, 2023; this increase is primarily driven by higher interest income from investments in debt securities due to an overall increase in interest rates and also an increase in the amount of marketable securities held.
Previous wording
The Company recorded an income tax expense of $4.6 million for the six months ended June 30, 2024 and an income tax expense of $17.4 million for the six months ended June 30, 2023. For both periods, the income tax expense recorded was driven largely by the projected current tax liabilities associated with the tax recognition of payments received pursuant to the Vertex Agreement resulting in taxable income during the respective periods.
Current wording
The Company recorded an income tax benefit of $1.9 million for the three months ended September 30, 2024 and an income tax benefit of $17.4 million for the three months ended September 30, 2023. For both periods, the income tax benefit recorded was driven largely by the application of ASC 740 interim reporting guidance to the projected current tax liabilities for tax years 2024 and 2023.
Previous wording
Collaboration revenue was $153.8 million for the six months ended June 30, 2024 and $43.4 million for the six months ended June 30, 2024. The $110.4 million increase was primarily driven by the additional research activities completed during the six months ended June 30, 2024, as well as the milestone related to the clinical advancement of VX-670 that was achieved in March of 2024 and added to the transaction price.
Current wording
Collaboration revenue was $173.4 million for the nine months ended September 30, 2024 and $87.2 million for the nine months ended September 30, 2023. The $86.2 million increase was primarily driven by the additional research activities completed during the nine months ended September 30, 2024, as well as the milestone related to the clinical advancement of VX-670 that was achieved in the first quarter of 2024 and added to the transaction price.
Previous wording
Research and development expenses were $60.6 million for the six months ended June 30, 2024, compared to $49.4 million for the six months ended June 30, 2023. The increase of $11.2 million in research and development expenses was primarily attributable to:
Current wording
Research and development expenses were $91.9 million for the nine months ended September 30, 2024, compared to $71.6 million for the nine months ended September 30, 2023. The increase of $20.3 million in research and development expenses was primarily attributable to:
Previous wording
•an increase of $7.0 million in internal costs driven by increased headcount in our research and development function, inclusive of stock-based compensation expense of $3.6 million and $2.7 million for the six months ended June 30, 2024 and 2023, respectively, and;
Current wording
•an increase of $11.5 million in internal costs driven by increased headcount in our research and development function, inclusive of stock-based compensation expense of $5.8 million and $4.3 million for the nine months ended September 30, 2024 and 2023, respectively, and;
Previous wording
•an increase of $4.2 million in external costs primarily driven by additional preclinical costs incurred for ENTR-601-50, higher research activities performed for VX-670 and additional costs incurred related to discovery programs as we continue investing in our platform
Current wording
•an increase of $8.8 million in external costs primarily driven by additional preclinical costs incurred for ENTR-601-50, research activities performed for VX-670 and additional costs incurred related to discovery programs as we continue investing in our platform
Previous wording
We expect that our research and development expenses will increase as we advance ENTR-601-44 / ENTR-601-45 through clinical trials, and ENTR-601-50 through preclinical development and into clinical trials, support our partnered candidate, VX-670, and continue to perform discovery work for future product candidates.
Current wording
We expect that our research and development expenses will increase as we advance ENTR-601-44 / ENTR-601-45 through clinical trials, and ENTR-601-50 through preclinical development and into clinical trials, perform research activities under the Vertex Agreement and continue to perform discovery work for future product candidates.
Previous wording
General and administrative expenses for the six months ended June 30, 2024 were $18.6 million, compared to $16.1 million for the six months ended June 30, 2023. The increase of $2.5 million was primarily attributable to higher personnel costs as our headcount in our general and administrative function increased. Our general and administrative personnel costs for the six months ended June 30, 2024 and 2023 are inclusive of stock-based compensation expense of$4.7 million and$3.2 million, respectively.
Current wording
General and administrative expenses for the nine months ended September 30, 2024 were $28.6 million, compared to $23.6 million for the nine months ended September 30, 2023. The increase of $5.0 million was primarily attributable to higher personnel costs as our headcount in our general and administrative function increased. Our general and administrative personnel costs for the nine months ended September 30, 2024 and 2023 are inclusive of stock-based compensation expense of$7.5 million and$5.0 million, respectively.
Previous wording
Total interest and other income, net was$4.4 million for thethree months ended June 30, 2024, compared to$4.2 million of interest and other income for thethree months ended June 30, 2023; this increase is primarily driven by higher interest income from investments in debt securities due to an overall increase in interest rates.
Current wording
Total interest and other income, net was$14.3 million for thenine months ended September 30, 2024, compared to$10.9 million of interest and other income for thenine months ended September 30, 2023; this increase is primarily driven by higher interest income from investments in debt securities due to an overall increase in interest rates and also an increase in the amount of marketable securities held.
Previous wording
The Company recorded an income tax expense of $2.8 million for the three months ended June 30, 2024 and an income tax expense of $13.8 million for the three months ended June 30, 2023. For both periods, the income tax expense recorded was driven largely by the projected current tax liabilities associated with the tax recognition of payments received pursuant to the Vertex Agreement resulting in taxable income during the respective periods.
Current wording
The Company recorded an income tax expense of $2.7 million for the nine months ended September 30, 2024 and an income tax expense of $0.0 million for the nine months ended September 30, 2023. For both periods, the income tax expense or benefit recorded was driven largely by the application of ASC 740 interim reporting guidance to the projected current tax liabilities for tax years 2024 and 2023.
Previous wording
Since our inception in 2016, we have incurred significant operating losses. As of June 30, 2024 and December 31, 2023, we had an accumulated deficit of $116.4 million and $195.0 million, respectively. We expect to generate significant operating losses and negative operating cash flows for the foreseeable future as we advance our platform and EEV therapeutic candidates. Since our inception, we have raised over $850.0 million of gross proceeds from sales of stock to leading biotechnology investors and from the Vertex Agreement. As of June 30, 2024, we had cash, cash equivalents and marketable securities of $469.7 million.
Current wording
Since our inception in 2016, we have incurred significant operating losses. As of September 30, 2024 and December 31, 2023, we had an accumulated deficit of $130.5 million and $195.0 million, respectively. We expect to generate significant operating losses and negative operating cash flows for the foreseeable future as we advance our EEV Platform and therapeutic candidates. Since our inception, we have raised over $850.0 million of gross proceeds from sales of stock to leading biotechnology investors and from the Vertex Agreement. As of September 30, 2024, we had cash, cash equivalents and marketable securities of $449.3 million.
Previous wording
For thesix months ended June 30, 2024, net cash provided by operating activities was $14.3 million, driven by our net income of $78.5 million, as adjusted for non-cash items consisting of stock-based compensation expense of $8.4 million, depreciation expense of $1.8 million, and accretion of premiums and discounts of $4.3 million, partially offset by net cash used in changes in our operating assets and liabilities of $70.1 million.
Current wording
For thenine months ended September 30, 2024, net cash used in operating activities was $10.0 million and consisted of our net income of $64.5 million, net cash used in changes in our operating assets and liabilities of $83.0 million, adjustments for non-cash expenses relating to stock-based compensation expense of $13.2 million and depreciation expense of $2.8 million, and adjustments for non-cash income relating to accretion of premiums and discounts of $7.5 million.
Previous wording
For thesix months ended June 30, 2023, net cash provided by operating activities was $168.3 million, driven by our net loss of $32.6 million, net cash provided by changes in our operating assets and liabilities of $195.6 million primarily resulting from the upfront payment received in connection with the Vertex Agreement, and adjustments for non-cash expenses relating to stock-based compensation expense of $5.9 million, depreciation expense of $1.3 million, and accretion of premiums and discounts on marketable securities of $1.9 million.
Current wording
For thenine months ended September 30, 2023, net cash provided by operating activities was $143.8 million and consisted of our net income of $2.9 million, net cash provided by changes in our operating assets and liabilities of $133.4 million, primarily resulting from the upfront payment received in connection with the Vertex Agreement, adjustments for non-cash expenses relating to stock-based compensation expense of $9.3 million and depreciation expense of $2.0 million, and adjustments for non-cash income relating to accretion of premiums and discounts on marketable securities of $3.8 million.
Previous wording
Net cash provided by investing activities was $1.8 million for thesix months ended June 30, 2024, consisting primarily of $211.3 million from the maturities of marketable securities, partially offset by $207.6 million in purchases of marketable securities and $1.9 million of purchases of property and equipment.
Current wording
Net cash used in investing activities was $81.2 million for thenine months ended September 30, 2024, consisting primarily of $373.2 million in purchases or marketable securities and $2.5 million of purchases of property and equipment, partially offset by $294.5 million from the maturities of marketable securities.
Previous wording
Net cash used in investing activities was $153.7 million for thesix months ended June 30, 2023, consisting primarily of $241.9 million in purchases of marketable securities and $3.2 million from purchases of property and equipment, partially offset by $91.4 million from the maturities of marketable securities.
Current wording
Net cash used in investing activities was $157.4 million for thenine months ended September 30, 2023, consisting primarily of $318.7 million in purchases of marketable securities and $4.6 million from purchases of property and equipment, partially offset by $165.9 million from the maturities of marketable securities.
Previous wording
Net cash provided by financing activities was $101.6 million for thesix months ended June 30, 2024, consisting of $100.0 million of proceeds from sales of our common stock and pre-funded warrants, $1.3 million in proceeds from stock option exercises and $0.3 million from the issuance of common stock under our employee stock purchase plan.
Current wording
Net cash provided by financing activities was $101.6 million for thenine months ended September 30, 2024, consisting of $99.6 million of proceeds from sales of our common stock and pre-funded warrants, $1.7 million in proceeds from stock option exercises and $0.3 million from the issuance of common stock under our employee stock purchase plan.
Previous wording
Net cash provided by financing activities was $20.0 million for thesix months ended June 30, 2023, consisting of $19.4 million in net proceeds from the issuance of 1,618,613 shares in connection with the Vertex Agreement, $0.4 million of proceeds from stock option exercises and $0.2 million from the issuance of common stock under our employee stock purchase plan.
Current wording
Net cash provided by financing activities was $20.3 million for thenine months ended September 30, 2023, consisting of $19.4 million in net proceeds from the issuance of 1,618,613 shares in connection with the Vertex Agreement, $0.8 million of proceeds from stock option exercises and $0.2 million from the issuance of common stock under our employee stock purchase plan.
Previous wording
We have also entered into license agreements under which we are obligated to make certain payments. During the three months ended June 30, 2024, there were no material changes to our commitments and contingencies related to our license agreements from those described in “Business—Intellectual property— License agreement with The Ohio State University” and Note 10, Commitments and Contingencies, to our financial statements in the Annual Report, with the exception of the sublicense fee paid to OSIF in July of 2024 that we accrued for as of June 30, 2024 in connection with the milestone achieved in the first quarter of 2024 under the Vertex Agreement. For additional information regarding our license agreements, refer to Note 11, Commitments and Contingencies, to our condensed consolidated financial statements in this Quarterly Report.
Current wording
We have also entered into license agreements under which we are obligated to make certain payments. During the three months ended September 30, 2024, there were no material changes to our commitments and contingencies related to our license agreements from those described in “Business—Intellectual property— License agreement with The Ohio State University” and Note 10, Commitments and Contingencies, to our financial statements in the Annual Report. For additional information regarding our license agreements, refer to Note 11, Commitments and Contingencies, to our condensed consolidated financial statements in this Quarterly Report.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
The primary objective of the Phase 1 clinical trial was to evaluate the safety and tolerability of a single dose of ENTR-601-44. The trial also evaluated pharmacokinetics and target engagement, as measured by exon skipping in the skeletal muscle. These data were featured in a poster presentation at the 29th Annual Congress of the World Muscle Society, which took place in Prague, Czechia between October 8-12, 2024.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
Collaboration revenue was $94.7 million for the three months ended June 30, 2024 and $18.2 million for the three months ended June 30, 2023. The increase was primarily driven by the additional research activities completed during the three months ended June 30, 2024, as well as the milestone related to the clinical advancement of VX-670 that was achieved in March of 2024 and added to the transaction price.