Viridian Therapeutics IncDE

Previous wording

We are conducting a global pivotal program for VRDN-001, including evaluating its efficacy and safety in two global well controlled Phase 3 clinical trials, THRIVE and THRIVE-2, for the treatment of active and chronic TED, respectively. THRIVE and THRIVE-2 are each designed to compare a five-dose IV treatment arm of VRDN-001 at 10 mg/kg, dosed three weeks apart, to placebo. This five-dose VRDN-001 regimen features fewer infusions and a shorter time per infusion compared to teprotumumab, the currently marketed IGF-1R inhibitor. We expect to report topline THRIVE and THRIVE-2 data in September 2024 and by year end 2024, respectively. In addition, to meet the 300 patient safety database requirements for a BLA filing, we are actively enrolling patients into our recently initiated STRIVE clinical trial. STRIVE is a global study of VRDN-001 in TED patients that utilizes broad inclusion criteria (e.g., any severity or duration of disease) and is randomized 3:1 (10 mg/kg IV with an active control of 3 mg/kg IV). We are also enrolling patients in the open label extension study for non-responding patients in THRIVE and THRIVE-2. We anticipate filing a BLA for VRDN-001 in the second half of 2025.

Current wording

We are conducting a global pivotal program for VRDN-001, including evaluating its efficacy and safety in two global well-controlled phase 3 clinical trials, THRIVE and THRIVE-2, for the treatment of active and chronic TED, respectively. THRIVE and THRIVE-2 are each designed to compare a five-dose IV treatment arm of VRDN-001 at 10 mg/kg, dosed three weeks apart, to placebo. This five-dose VRDN-001 regimen features fewer infusions and a shorter time per infusion compared to teprotumumab, the currently marketed IGF-1R inhibitor. We expect to report topline THRIVE and THRIVE-2 data in September 2024 and by year end 2024, respectively. In addition, to meet the 300 patient standard safety database requirements for the VRDN-001 BLA, we are actively enrolling patients into our STRIVE clinical trial. STRIVE is a global study of VRDN-001 in TED patients that utilizes broad inclusion criteria (e.g., any severity or duration of disease) and is randomized 3:1 (10 mg/kg IV with an active control of 3 mg/kg IV). We are also enrolling patients in the open label extension study for non-responding patients in THRIVE and THRIVE-2. We anticipate filing a BLA for VRDN-001 in the second half of 2025.

Previous wording

In addition to our VRDN-001 IV program, in December 2023 we selected VRDN-003 as our prioritized subcutaneous program for pivotal development in TED following positive data in a Phase 1 clinical trial in healthy volunteers. We believe VRDN-003 has the potential to be the best-in-class subcutaneous anti-IGF-1R program by preserving the efficacy of anti-IGF-1Rs in TED, improving safety, and maximizing convenience for patients. VRDN-003 has the same binding domain as its parent molecule, VRDN-001, and was engineered to have a longer half-life. VRDN-003 is designed to be a low-volume, self-administered, infrequently-dosed subcutaneous IGF-1R for TED.

Current wording

In addition to our VRDN-001 IV program, in December 2023 we selected VRDN-003 as our subcutaneous product candidate for pivotal development in TED following positive data in a phase 1 clinical trial in healthy volunteers. We believe VRDN-003 has the potential to be the best-in-class subcutaneous anti-IGF-1R product candidate by preserving the efficacy of anti-IGF-1Rs in TED, improving safety, and maximizing convenience for patients. VRDN-003 has the same binding domain as, VRDN-001, and was engineered to have a longer half-life. VRDN-003 is designed to be a low-volume, self-administered, infrequently dosed subcutaneous IGF-1R for TED, which we plan to launch commercially with an auto-injector.

Previous wording

The VRDN-003 Phase 1 clinical study showed VRDN-003 to have a prolonged half-life of 40 to 50 days, which is four to five times that of its parent molecule, VRDN-001. Because of the similarities between the VRDN-001 and VRDN-003 antibodies, we expect VRDN-003 to have similar clinical responses at the exposure levels of

Current wording

The VRDN-003 phase 1 clinical study showed VRDN-003 to have a prolonged half-life of 40 to 50 days, which is four to five times that of VRDN-001. Because of the healthy volunteer data and the similarities between the VRDN-001 and VRDN-003 antibodies, we expect VRDN-003 to have similar clinical responses at the exposure levels of VRDN-001 that led to robust clinical activity in its phase 2 clinical trial in TED. Further, pharmacokinetic modeling of VRDN-003 based on the healthy volunteer data predicted that exposure levels of VRDN-003 could be achieved that are equivalent to exposure levels of VRDN-001 that produced clinically meaningful results with multiple dosing regimens of VRDN-003, i.e., subcutaneous injection every two, four, or eight weeks. We are advancing our VRDN-003 program, including initiating two planned global phase 3 clinical trials, REVEAL-1 and REVEAL-2, to evaluate the efficacy and safety of VRDN-003 in patients with active and chronic TED. We also anticipate that the program will include a safety study to complete a 300 patient standard safety database (to include patients from the REVEAL-1 and REVEAL-2 trials), and we expect that it will also include the required development to have an auto-injector device available at the time of commercial launch, if approved. We anticipate topline data for REVEAL-1 and REVEAL-2 in the first half of 2026, and we anticipate submitting a BLA for VRDN-003 by the end of 2026.

Previous wording

In addition to developing therapies for TED, we are also developing a portfolio of engineered anti-FcRn inhibitors, including VRDN-006 and VRDN-008. FcRn inhibitors have the potential to treat a broad array of autoimmune diseases, representing a possible significant commercial market opportunity. Our multi-pronged engineering approach has resulted in a portfolio of FcRn-targeting molecules that leverage the clinically and commercially validated mechanism of FcRn inhibition while potentially addressing the limitations of current agents such as incomplete IgG suppression, safety, and inconvenience of dosing.

Current wording

In addition to developing therapies for TED, we have also prioritized developing a portfolio of engineered anti-FcRn inhibitors, including VRDN-006 and VRDN-008. FcRn inhibitors have the potential to treat a broad array of autoimmune diseases, representing a possible significant commercial market opportunity. Our multi-pronged engineering approach has resulted in a portfolio of FcRn-targeting molecules that leverage the clinically and commercially validated mechanism of FcRn inhibition while potentially addressing the limitations of current agents such as incomplete immunoglobulin G (“IgG”) suppression, safety, and inconvenience of dosing.

Previous wording

VRDN-006 is a FcRn-targeting Fc fragment, and in non-human primate studies, demonstrated specificity for blocking FcRn-IgG interactions while not showing decreases in albumin or increases in LDL levels, which are known potential side effects associated with certain full-length monoclonal anti-FcRn antibodies. In our head-to-head non-human primate studies, VRDN-006 demonstrated comparable potency and IgG lowering to Vyvgart® (efgartigimod), the current standard of care in FcRn inhibition, as well as a similar safety profile. We plan to file an IND for VRDN-006 by the end of 2024 and expect healthy volunteer data for VRDN-006 in the second half of 2025. VRDN-008 is a novel, first-in-class FcRn inhibitor that aims to pair IgG suppression with extended half-life technology, potentially enabling deeper and more durable suppression of IgG than existing anti-FcRn therapies. Both molecules are designed to be convenient, self-administered, subcutaneous products.

Current wording

VRDN-006 is a FcRn-targeting Fc fragment, and in non-human primate studies, demonstrated specificity for blocking FcRn-IgG interactions while not showing decreases in albumin or increases in LDL levels, which are known potential side effects associated with certain full-length anti-FcRn monoclonal antibodies. In our head-to-head non-human primate studies, VRDN-006 demonstrated comparable potency and IgG reductions to Vyvgart® (efgartigimod), the current standard of care in FcRn inhibition, as well as a similar safety profile. We plan to file an IND for VRDN-006 by the end of 2024 and expect healthy volunteer data for VRDN-006 in the second half of 2025. VRDN-008 is a novel, potential first-in-class FcRn inhibitor that aims to pair IgG suppression with extended half-life technology, potentially enabling deeper and more durable suppression of IgG than existing anti-FcRn therapies. Both molecules are designed to be convenient, self-administered, subcutaneous products.

Previous wording

In October 2020, we became party to a license agreement with Zenas BioPharma (Cayman) Limited (“Zenas BioPharma”). Since February 2021, we have entered into several letter agreements with Zenas BioPharma in which we agreed to provide assistance to Zenas BioPharma with certain development activities, including manufacturing (collectively with the license agreement, the “Zenas Agreements”). Under the terms of the Zenas Agreements, we granted Zenas BioPharma an exclusive license to develop, manufacture, and commercialize certain IGF-1R directed antibody products for non-oncology indications in the greater area of China in exchange for upfront non-cash consideration and non-refundable milestone payments upon achieving specific milestone events during the contract term. Zenas BioPharma announced that it had obtained IND approval in China in July 2022. Under the license agreement, we received a $1.0 million milestone payment from Zenas

Current wording

In October 2020, we became party to a license agreement with Zenas BioPharma (Cayman) Limited (“Zenas BioPharma”). Since February 2021, we have entered into several letter agreements with Zenas BioPharma in which we agreed to provide assistance to Zenas BioPharma with certain development activities, including manufacturing (collectively with the license agreement, the “Zenas Agreements”). Under the terms of the Zenas Agreements, we granted Zenas BioPharma an exclusive license to develop, manufacture, and commercialize certain IGF-1R directed antibody products for non-oncology indications in the greater area of China in exchange for upfront non-cash consideration and non-refundable milestone payments upon achieving specific milestone events during the contract term. Zenas BioPharma announced that it had obtained IND approval in China in July 2022. Under the license agreement, we received a $1.0 million milestone payment from Zenas BioPharma. Additionally, we are eligible to receive royalty payments based on a percentage of the annual net sales of any licensed products sold on a country-by-country basis in the greater area of China. The royalty percentage may vary based on different tiers of annual net sales of the licensed products made. Zenas BioPharma is obligated to make royalty payments to us for the royalty term in the Zenas Agreements. In May 2022, we entered into a Manufacturing Development and Supply Agreement with Zenas BioPharma to manufacture and supply, or have manufactured and supplied, clinical drug product for development purposes.

Previous wording

We record up-front and milestone payments to acquire and retain contractual rights to in-licensed technology and intellectual property rights as research and development expenses when incurred if there is uncertainty in our receiving future economic benefit from the acquired contractual rights. We consider future economic benefits from acquired contractual rights to licensed technology to be uncertain until such a drug candidate is approved by the FDA or when other significant risk factors are abated.

Current wording

We record up-front and milestone payments to acquire and retain contractual rights to in-licensed technology and intellectual property rights as research and development expenses when incurred if there is uncertainty in our receiving future economic benefit from the acquired contractual rights. We consider future economic benefits from acquired contractual rights to licensed technology to be uncertain until such a drug candidate is approved by the FDA or other regulatory authorities, or when other significant risk factors are abated.

Previous wording

There were no changes to our critical accounting policies as disclosed in our 2023 Annual Report on Form 10-K during the three months ended March 31, 2024. Our significant accounting policies are disclosed in Note 2. Summary of Significant Accounting Policies to our condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report.

Current wording

There were no changes to our critical accounting policies as disclosed in our 2023 Annual Report on Form 10-K during the six months ended June 30, 2024. Our significant accounting policies are disclosed in Note 2. Summary of Significant Accounting Policies to our condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report.

Previous wording

Research and development expenses were $40.9 million during the three months ended March 31, 2024, compared to $50.7 million during the three months ended March 31, 2023. The $9.8 million decrease in research and development expenses is primarily attributable to the following:

Current wording

Research and development expenses were $56.2 million during the three months ended June 30, 2024, compared to $40.1 million during the three months ended June 30, 2023. The $16.1 million increase in research and development expenses is primarily attributable to the following:

Previous wording

•$9.1 million increase in clinical trial costs mainly due to expenses associated with our THRIVE and THRIVE-2 clinical trials;

Current wording

•$11.7 million increase in clinical trial costs mainly due to expenses associated with our ongoing THRIVE and THRIVE-2 clinical trials;

Previous wording

•$0.5 million increase in personnel-related costs, primarily due to increased share-based compensation expense.

Current wording

•$2.3 million increase in personnel related costs, due primarily to increased share-based compensation and other employee compensation and recruiting costs; and

Previous wording

•$3.0 million increase in severance costs primarily related to separation agreements with former executive officers, including a $2.1 million increase in share-based compensation related to the acceleration of stock option vesting during the three months ended March 31, 2024; and

Current wording

•$1.5 million increase in severance costs primarily related to separation agreements with former executive officers, including a $1.1 million increase in share-based compensation related to the acceleration of stock option vesting during the three months ended June 30, 2024.

Previous wording

We expect our research and development expenses to increase as we work to progress our clinical and preclinical programs.

Current wording

We expect our research and development expenses to increase as we continue to advance our clinical and preclinical programs.

Previous wording

Other income, net was $7.4 million during the three months ended March 31, 2024 compared to $4.3 million during the three months ended March 31, 2023. Other income, net for the three months ended March 31, 2024 is comprised of $7.9 million of interest income earned on short-term investments as well as$0.1 million of sub-lease income, offset by $0.6 million in interest expense related to our Hercules Loan and Security Agreement (as defined below). Other income, net for the three months ended March 31, 2023 is comprised of $4.4 million of interest income earned on short-term investments as well as $0.1 million of sub-lease income, offset by $0.2 million in interest expense related to our Hercules Loan and Security Agreement. The increase in interest income is primarily attributable to higher average short-term investments balances during the three months ended March 31, 2024 as compared to the three months ended March 31, 2023.

Current wording

Other income, net was $7.2 million during the three months ended June 30, 2024 compared to $4.2 million during the three months ended June 30, 2023. Other income, net for the three months ended June 30, 2024 is comprised of $7.7 million of interest income earned on short-term investments as well as$0.1 million of sub-lease income, offset by $0.6 million in interest expense related to our Hercules Loan and Security Agreement (as defined below). Other income, net for the three months ended June 30, 2023 is comprised of $4.3 million of interest income earned on short-term investments as well as $0.1 million of sub-lease income, offset by $0.2 million in interest expense related to our Hercules Loan and Security Agreement. The increase in interest income, as compared to prior year, is primarily attributable to higher average short-term investment balances during the three months ended June 30, 2024 as compared to the three months ended June 30, 2023.

Previous wording

Revenue for both the three months ended March 31, 2024 and 2023 was attributable to our collaboration agreement with Zenas BioPharma. The $26 thousand decrease in revenue is due to the timing of activities performed under the collaboration agreement.

Current wording

Revenue for both the six months ended June 30, 2024 and 2023 was attributable to our collaboration agreement with Zenas BioPharma. The $26.0 thousand decrease in revenue is due to the timing of activities performed under the collaboration agreement.

Previous wording

•$7.5 million decrease in severance costs primarily related to separation agreements with former executive officers, including a $6.8 million decrease in share-based compensation related to the modification and acceleration of stock option vesting during the three months ended March 31, 2023; partially offset by

Current wording

•$4.5 million increase in severance costs primarily related to separation agreements with former executive officers, including a $3.2 million increase in share-based compensation related to the acceleration of stock option vesting during the six months ended June 30, 2024; and

Previous wording

•$2.6 million increase in personnel related costs, due primarily to increased share-based compensation and other employee compensation and recruiting costs.

Current wording

•$4.9 million increase in personnel related costs, due primarily to increased share-based compensation and other employee compensation and recruiting costs.

Previous wording

•$15.0 million decrease in milestone, license and option fees due to the upfront payment for development of subcutaneous delivery systems during the three months ended March 31, 2023;

Current wording

•$20.0 million decrease in milestone, license and option fees due to the $15.0 million upfront payment for development of subcutaneous delivery systems and a $5.0 million upfront payment for an exclusive license and collaboration agreement incurred during the six months ended June 30, 2023; and

Previous wording

•$4.7 million decrease in preclinical costs due to timing and stage of ongoing clinical trials and preclinical assets; partially offset by

Current wording

•$3.4 million decrease in preclinical costs due to timing of development of our preclinical assets.

Previous wording

General and administrative expenses were $15.0 million during the three months ended March 31, 2024, compared to $21.8 million during the three months ended March 31, 2023. The $6.8 million decrease in general and administrative expenses is primarily attributable to the following:

Current wording

General and administrative expenses were $31.1 million during the six months ended June 30, 2024, compared to $41.1 million during the six months ended June 30, 2023. The $10.0 million decrease in general and administrative expenses is primarily attributable to the following:

Previous wording

We have funded our operations to date principally through proceeds received from the sale of our common stock, our Series A Preferred Stock, our Series B Preferred Stock and other equity securities, debt financings, license fees, and reimbursements received under collaboration agreements. As of March 31, 2024, we had $613.2 million in cash, cash equivalents, and short-term investments. We expect that our current cash, cash equivalents and short-term investments will be sufficient to fund our operations, including our clinical development plan described above, into the second half of 2026.

Current wording

We have funded our operations to date principally through proceeds received from the sale of our common stock, our Series A Preferred Stock, our Series B Preferred Stock and other equity securities, debt financings, license fees, and reimbursements received under collaboration agreements. As of June 30, 2024, we had $571.4 million in cash, cash equivalents, and short-term investments. We expect that our current cash, cash equivalents and short-term investments will be sufficient to fund our operations, including our clinical development plan described above, into the second half of 2026. In addition, as of June 30, 2024, the Company has access to additional undrawn funds under the Hercules Amended Term Loan, as described below.

Previous wording

We have no products approved for commercial sale and have not generated any revenue from product sales. Since our inception and through March 31, 2024, we have generated an accumulated deficit of $774.5 million. Substantially all of our operating losses resulted from expenses incurred in connection with our research and development programs and from general and administrative costs associated with our operations.

Current wording

We have no products approved for commercial sale and have not generated any revenue from product sales. Since our inception and through June 30, 2024, we have generated an accumulated deficit of $839.4 million.

Previous wording

Per the terms of the Hercules Loan and Security Agreement, we were originally obligated to make interest-only payments through April 1, 2024. However, upon the achievement of a development milestone in August 2022, the interest-only period was extended to October 1, 2024. If additional development milestones were met, the interest-only period would be further extended to April 1, 2025 pursuant to a second extension. We were required to repay the Term Loan amount in equal monthly installments of the principal amount and interest between the end of the interest-only period and the maturity date of October 1, 2026. In addition, we were required to pay an end-of-term fee equal to 6% of the principal amount of funded Term Loan Advances (se defined in the Hercules Loan and Security Agreement) at maturity, which were being accreted as additional interest expense over the term of the loan.

Current wording

Per the terms of the Hercules Loan and Security Agreement, we were originally obligated to make interest-only payments through April 1, 2024. However, upon the achievement of a development milestone in August 2022, the interest-only period was extended to October 1, 2024. If additional development milestones were met, the interest-only period would be further extended to April 1, 2025 pursuant to a second extension. We were required to repay the Term Loan amount in equal monthly installments of the principal amount and interest between the end of the interest-only period and the maturity date of October 1, 2026. In addition, we were required to pay an end-of-term fee equal to 6% of the principal amount of funded Term Loan Advances (as defined in the Hercules Loan and Security Agreement) at maturity, which were being accreted as additional interest expense over the term of the loan.

Previous wording

Per the terms of the Hercules Amendment, we are obligated to make interest-only payments through April 1, 2025. If certain development milestones are met, then the interest-only period will be extended to October 1, 2025. If additional development milestones are met, the interest-only period will be further extended to April 1, 2026. The Borrower is required to repay the Amended Term Loan amount in equal monthly installments of the principal amount and interest between the end of the interest-only period and the maturity date of October 1, 2026. In addition, the Borrower is required to pay an end-of-term fee equal to 6% of the principal amount of funded Amended Term Loan advances at maturity, which are being accreted as additional interest expense over the term of the loan.

Current wording

Per the terms of the Hercules Amendment, we are obligated to make interest-only payments through April 1, 2025. If certain development milestones related to our topline results for our ongoing phase 3 THRIVE or THRIVE-2 trials are met, then the interest-only period will be extended to October 1, 2025. If additional development milestones are met, the interest-only period will be further extended to April 1, 2026. The Borrower is required to repay the Amended Term Loan amount in equal monthly installments of the principal amount and interest between the end of the interest-only period and the maturity date of October 1, 2026. In addition, the Borrower is required to pay an end-of-term fee equal to 6% of the principal amount of funded Amended Term Loan advances at maturity, which are being accreted as additional interest expense over the term of the loan.

Previous wording

In January 2024, we entered into an underwriting agreement with Jefferies LLC (“Jefferies”) and Leerink Partners LLC (“Leerink Partners”) relating to the offer and sale (the “2024 Public Offering”) of 7,142,858 shares of our common stock at a public offering price of $21.00 per share. The aggregate gross proceeds to us from the 2024 Public Offering were approximately $150.0 million, before deducting underwriting discounts and commissions and other offering expenses payable by us.

Current wording

In January 2024, we entered into an underwriting agreement with Jefferies LLC (“Jefferies”) and Leerink Partners LLC relating to the offer and sale (the “2024 Public Offering”) of 7,142,858 shares of our common stock at a public offering price of $21.00 per share. The aggregate gross proceeds to us from the 2024 Public Offering were approximately $150.0 million, before deducting underwriting discounts and commissions and other offering expenses payable by us.

Previous wording

In September 2022, we entered into an Open Market Sale Agreement SM (the “September 2022 ATM Agreement”) with Jefferies pursuant to which we may offer and sell shares of our common stock having an aggregate offering price of up to $175.0 million from time to time at prices and on terms to be determined by market conditions at the time of offering, with Jefferies acting as the sales agent. Jefferies will receive a commission of 3.0% of the gross proceeds of any shares of common stock sold under the September 2022 ATM Agreement. During the year ended December 31, 2023, the Company sold 684,298 shares under the September 2022 ATM Agreement with Jefferies at a weighted average price of $22.30 per share, for aggregate net proceeds of approximately $14.8 million, including commissions to Jefferies as a sales agent. During the three months ended March 31, 2024, we sold 1,561,570 shares under the September 2022 ATM Agreement with Jefferies at a weighted average price of $23.22 per share, for aggregate net proceeds of approximately $35.2 million, including commissions to Jefferies as a sales agent.

Current wording

In September 2022, we entered into an Open Market Sale Agreement SM (the “September 2022 ATM Agreement”) with Jefferies pursuant to which we may offer and sell shares of our common stock having an aggregate offering price of up to $175.0 million from time to time at prices and on terms to be determined by market conditions at the time of offering, with Jefferies acting as the sales agent. Jefferies will receive a commission of 3.0% of the gross proceeds of any shares of common stock sold under the September 2022 ATM Agreement. During the year ended December 31, 2023, the Company sold 684,298 shares under the September 2022 ATM Agreement with Jefferies at a weighted average price of $22.30 per share, for aggregate net proceeds of approximately $14.8 million, including commissions to Jefferies as a sales agent. During the six months ended June 30, 2024, we sold 1,561,570 shares under the September 2022 ATM Agreement with Jefferies at a weighted average price of $23.22 per share, for aggregate net proceeds of approximately $35.2 million, including commissions to Jefferies as a sales agent. During the three months ended June 30, 2024, there were no sales under the September 2022 ATM Agreement.

Previous wording

Summarized cash flows for the three months ended March 31, 2024 and 2023 are as follows:

Current wording

Summarized cash flows for the six months ended June 30, 2024 and 2023 are as follows:

Previous wording

Net cash used in operating activities was $45.2 million for the three months ended March 31, 2024, and primarily consisted of our net loss of $48.5 million, adjusted for non-cash items of $8.3 million (primarily share-based compensation of $12.7 million, offset by accretion and amortization of premiums and discounts on available-for-sale securities of $4.7 million), and changes in working capital of $5.0 million. The change in working capital was primarily related to a decrease of $0.4 million in accounts payable and accrued and other liabilities and an increase of $4.5 million in prepaid expenses and other current assets due to the timing of payments and prepayments to vendors for ongoing clinical trial and manufacturing activities.

Current wording

Net cash used in operating activities was $91.3 million for the six months ended June 30, 2024, and primarily consisted of our net loss of $113.5 million, adjusted for non-cash items of $16.1 million (primarily share-based compensation of $24.5 million, offset by the accretion and amortization of premiums and discounts on available-for-sale securities of $9.1 million), and changes in working capital of $6.2 million. The change in working capital was primarily related to a net increase of $7.6 million in accounts payable and accrued and other liabilities and an increase of $1.3 million in prepaid expenses and other current assets due to the timing of payments to vendors for ongoing clinical trial and manufacturing activities.

Previous wording

Net cash used in operating activities was $62.0 million for the three months ended March 31, 2023, and primarily consisted of a net loss of $68.2 million, adjusted for non-cash items of $12.4 million (primarily share-based compensation of $15.2 million) and changes in working capital of $6.3 million. The change in working capital was primarily related to a decrease of $4.1 million in accounts payable and accrued and other liabilities and an increase of $2.1 million in prepaid expenses and other current assets due to the timing of payments and prepayments to vendors for ongoing clinical trial and manufacturing activities.

Current wording

Net cash used in operating activities was $107.2 million for the six months ended June 30, 2023, and primarily consisted of a net loss of $123.2 million, adjusted for non-cash items of $27.0 million (primarily share-based compensation of $27.5 million) and changes in working capital of $11.0 million. The change in working capital was primarily related to a net decrease of $4.7 million in accounts payable and accrued and other liabilities and an increase of $5.4 million in prepaid expenses and other current assets due to the timing of payments to vendors for ongoing clinical trial and manufacturing activities.

Previous wording

Net cash used in investing activities was $143.0 million during the three months ended March 31, 2024, and consisted primarily of $143.0 million in net purchases of short-term investments.

Current wording

Net cash used in investing activities was $81.1 million during the six months ended June 30, 2024, and consisted primarily of $81.0 million in net purchases of short-term investments.

Previous wording

Net cash used in investing activities was $13.3 million during the three months ended March 31, 2023, and consisted primarily of $13.2 million in net purchases of short-term investments and $0.1 million in purchases of property and equipment.

Current wording

Net cash provided by investing activities was $27.4 million during the six months ended June 30, 2023, and consisted primarily of $27.9 million in net maturities of short-term investments, offset by $0.4 million in purchases of property and equipment.

Previous wording

Net cash provided by financing activities was $177.1 million during the three months ended March 31, 2024, and consisted of primarily of net proceeds of $175.9 million from the 2024 Public Offering and the September 2022 ATM Agreement, as well as $0.8 million in proceeds from the exercise of stock options and $0.4 million in proceeds from the issuance of common stock under our employee stock purchase plan.

Current wording

Net cash provided by financing activities was $177.2 million during the six months ended June 30, 2024, and consisted of primarily of net proceeds of $175.8 million from the 2024 Public Offering and the September 2022 ATM Agreement, as well as $1.0 million in proceeds from the exercise of stock options and $0.4 million in proceeds from the issuance of common stock under our employee stock purchase plan.

Previous wording

Net cash provided by financing activities was $8.2 million during the three months ended March 31, 2023, and consisted primarily of $6.9 million in proceeds from the exercise of stock options, $0.9 million in proceeds from the exercise of warrants and $0.3 million in proceeds from the issuance of common stock under our employee stock purchase plan.

Current wording

Net cash provided by financing activities was $11.3 million during the six months ended June 30, 2023, and consisted primarily of $9.1 million in proceeds from the exercise of stock options, $1.9 million in proceeds from the exercise of warrants and $0.3 million in proceeds from the issuance of common stock under our employee stock purchase plan.