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Acrivon Therapeutics Inc

For the period ended Sep 30, 2024. Filed Nov 13, 2024.

View on SEC.gov

About this filing

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

Sep 30, 2024 · Filed Nov 13, 2024

ACRV$1.61+2.5%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2024-06-30; filed 2024-08-13.

0000950170-24-095760

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2024-09-30; filed 2024-11-13.

0000950170-24-125929

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

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

Compared 142 previous paragraphs and 148 current paragraphs.

103 unchanged; 35 reworded; 8 added; 4 removed; 0 previous and 2 current paragraphs rearranged.

Tables are not compared: 7 previous and 7 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 (8)

Current report

In September 2024, we reported additional positive clinical data at the European Society of Medical Oncology conference from the ongoing registrational intent, multicenter Phase 2 trial of ACR-368 in patients with locally advanced or metastatic, recurrent endometrial cancer who had progressed on prior anti-PD-1 therapy, unless ineligible. Endometrial cancer had not been previously studied in prior ACR-368 Lilly-sponsored trials. Using AP3 for indication screening, this tumor type was predicted to be particularly sensitive to ACR-368 prior to the current ongoing Phase 2 study. The data were based on 35 safety-evaluable patients, of which 23 (8 OncoSignature-positive (BM+) and 15 OncoSignature-negative (BM-) patients) were efficacy-evaluable with at least one on-treatment scan (data cut off July 25, 2024). This data included a confirmed overall response rate, or ORR, of 62.5% (95% CI, 30.4-86.5) observed in prospectively-selected ACR-368 OncoSignature-positive patients with endometrial cancer. The data further validated our AP3-based ACR-368 OncoSignature assay, which is used for prospective patient selection in this registrational intent trial, achieving a clear segregation of responders in the OncoSignature-positive versus OncoSignature-negative arms (p-value = 0.009).

Current report

In September 2024, we announced that the FDA had granted IND clearance for ACR-2316 and that initial clinical sites had been activated ahead of timelines with first-in-human dosing anticipated in the fourth quarter of 2024 for this Phase I clinical study. In October 2024, we announced that the first patient had been dosed in the Phase 1 clinical trial designed to assess the safety and tolerability of ACR-2316. Additional objectives of this trial include the determination of the maximal tolerated dose and recommended Phase 2 monotherapy dose, characterization of the pharmacokinetic profile, and preliminary evaluation of anti-tumor activity.

Current report

Research and development expenses were $18.9 million for the three months ended September 30, 2024, compared to $10.3 million for the three months ended September 30, 2023. The increase of $8.6 million was primarily driven by:

Current report

$1.7 million in costs related to the promotion of our novel, internally-discovered second clinical stage asset, ACR-2316, to a development program upon being granted IND clearance in the third quarter of 2024;

Current report

a $1.4 million net decrease in costs related to preclinical drug discovery activities progression, which prior to ACR-2316 being granted IND clearance in the third quarter of 2024 had included ACR-2316;

Current report

Comparison of the Nine Months Ended September 30, 2024 and 2023

Current report

$1.7 million in costs related to the promotion of our novel, internally-discovered second clinical stage asset, ACR-2316, to a development program upon being granted IND clearance in the third quarter of 2024;

Current report

a $1.4 million net decrease in costs related to preclinical drug discovery activities progression, which prior to ACR-2316 being granted IND clearance in the third quarter of 2024 had included ACR-2316;
Removed paragraphs (4)

Previous report

Research and development expenses were $15.0 million for the three months ended June 30, 2024, compared to $10.5 million for the three months ended June 30, 2023. The increase of $4.5 million was primarily driven by:

Previous report

a $0.2 million increase in costs related to the timing of preclinical drug discovery activities progression, inclusive of the novel, internally-discovered development candidate ACR-2316 that was declared in the third quarter of 2023; and

Previous report

a $0.2 million increase in legal, accounting and professional fees due to additional costs associated with operating as a public company; and
Reworded paragraphs (35)

Previous wording

You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited condensed consolidated financial statements and related notes and other financial information included elsewhere in this Quarterly Report on Form 10-Q, and the audited consolidated financial statements and notes thereto as of and for the year ended December 31, 2023 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K filed with the Securities and Exchange Commission, or the SEC, on March 28, 2024. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the “Special Note Regarding Forward-Looking Statements” and “Risk Factors” sections of this Quarterly Report on Form 10-Q, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. Unless the context requires otherwise, references in this Quarterly Report on Form 10-Q to “Acrivon,” the “Company,” “we,” “us,” and “our” refer to Acrivon Therapeutics, Inc. and its subsidiaries.

Current wording

You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited condensed consolidated financial statements and related notes and other financial information included elsewhere in this Quarterly Report on Form 10-Q, and the audited consolidated financial statements and notes thereto as of and for the year ended December 31, 2023 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K filed with the SEC on March 28, 2024. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the “Special Note Regarding Forward-Looking Statements” and “Risk Factors” sections of this Quarterly Report on Form 10-Q, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. Unless the context requires otherwise, references in this Quarterly Report on Form 10-Q to “Acrivon,” the “Company,” “we,” “us,” and “our” refer to Acrivon Therapeutics, Inc. and its subsidiaries.

Previous wording

We are a clinical stage precision medicine company utilizing our Acrivon Precision Predictive Proteomics (AP3) platform for the discovery, design, and development of drug candidates through a mechanistic match to patients whose disease is predicted sensitive to the specific treatment. Previously approved precision oncology treatments, such as kinase inhibitors, have transformed the cancer treatment landscape, and while the therapeutic benefit of these agents has provided significant benefit to patients, these precision oncology treatments unfortunately only address the less than 10% of patients with cancers that harbor certain easily-identifiable genetic mutations. In diseases outside oncology, e.g. autoimmune, inflammatory, fibrotic, and metabolic disorders, recurrent mutations in individual patients that can be linked to disease pathogenesis are exceedingly rare. Accordingly, genetics-based precision medicine approaches to treat only the patients that benefit from a particular therapeutic have been even more challenging in such diseases.

Current wording

We are a clinical stage precision medicine company utilizing our Acrivon Predictive Precision Proteomics, or AP3, platform for the discovery, design, and development of drug candidates through a mechanistic match to patients whose disease is predicted sensitive to the specific treatment. Previously approved precision oncology treatments, such as kinase inhibitors, have transformed the cancer treatment landscape, and while the therapeutic benefit of these agents has provided significant benefit to patients, these precision oncology treatments unfortunately only address the less than 10% of patients with cancers that harbor certain easily-identifiable genetic mutations. In diseases outside oncology, e.g. autoimmune, inflammatory, fibrotic, and metabolic disorders, recurrent mutations in individual patients that can be linked to disease pathogenesis are exceedingly rare. Accordingly, genetics-based precision medicine approaches to treat only the patients that benefit from a particular therapeutic have been even more challenging in such diseases.

Previous wording

On May 8, 2023, ACR-368 was granted two Fast Track designations from the U.S. Food and Drug Administration for the investigation of ACR-368 monotherapy for patients with OncoSignature-positive platinum-resistant ovarian cancer and endometrial cancer. On November 16, 2023, the ACR-368 OncoSignature test was granted Breakthrough Device Designation for the identification of ovarian cancer patients who may benefit from treatment with ACR-368. This designation reflects the FDA’s determination that the device is reasonably expected to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.

Current wording

In May 2023, ACR-368 was granted two Fast Track designations from the U.S. Food and Drug Administration, or the FDA, for the investigation of ACR-368 monotherapy for patients with OncoSignature-positive platinum-resistant ovarian cancer and endometrial cancer. On November 16, 2023, the ACR-368 OncoSignature test was granted Breakthrough Device Designation for the identification of ovarian cancer patients who may benefit from treatment with ACR-368. This designation reflects the FDA’s determination that the device is reasonably expected to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.

Previous wording

In addition to ACR-368, we are also leveraging our proprietary AP3 precision medicine platform to rationally design and develop internally-discovered co-crystallography-driven, preclinical stage pipeline programs. These include ACR-2316, a potent, selective WEE1/PKMYT1 inhibitor designed using AP3 for superior single-agent activity as demonstrated in preclinical studies against clinically relevant comparators, and a potential first-in-class cell cycle program for an undisclosed target initiated following the same AP3 approach. In April 2024, we announced new preclinical data for ACR-2316, including accelerated timelines, and we remain on track to start a Phase I clinical study in the fourth quarter of 2024.

Current wording

In addition to ACR-368, we are also leveraging our proprietary AP3 precision medicine platform to develop our co-crystallography-driven, internally-discovered pipeline programs. These include ACR-2316, our second clinical stage asset, a novel, potent, selective WEE1/PKMYT1 inhibitor designed using AP3 for superior single-agent activity through strong activation of not only CDK1 and CDK2, but also of PLK1 to drive pro-apoptotic cell death, as demonstrated in preclinical studies against benchmark inhibitors. In addition, we have a preclinical cell cycle program with an undisclosed target.

Previous wording

Since our inception in 2018, we have devoted substantially all of our resources toward conducting discovery and research activities, organizing and staffing our company, business planning, acquiring and internally discovering drug candidates, establishing and protecting our intellectual property portfolio, developing and progressing ACR-368 and the ACR-368 OncoSignature, preparing for and conducting preclinical studies and clinical trials, establishing arrangements with third parties for the manufacture of ACR-368, the ACR-368 OncoSignature and component materials, advancing our internal co-crystallography-driven, AP3-enabled preclinical programs, conducting preclinical and IND-enabling studies for ACR-2316, as well as raising capital. We do not have any drug candidates approved for sale and have not generated any revenue from drug sales.

Current wording

Since our inception in 2018, we have devoted substantially all of our resources toward conducting discovery and research activities, organizing and staffing our company, business planning, acquiring and internally discovering drug candidates, establishing and protecting our intellectual property portfolio, developing and progressing ACR-368 and the ACR-368 OncoSignature, preparing for and conducting preclinical studies and clinical trials, establishing arrangements with third parties for the manufacture of ACR-368, the ACR-368 OncoSignature and component materials, advancing our internal co-crystallography-driven, AP3-enabled preclinical programs, conducting preclinical studies and initiating a Phase 1b clinical trial for ACR-2316, as well as raising capital. We do not have any drug candidates approved for sale and have not generated any revenue from drug sales.

Previous wording

We have incurred operating losses since inception. Our net losses for the six months ended June 30, 2024 and 2023 were $35.3 million and $26.7 million, respectively. As of June 30, 2024, we had an accumulated deficit of $151.7 million. These losses have resulted primarily from costs incurred in connection with research and development activities and general and administrative costs associated with our operations. We expect to continue to incur significant and increasing expenses and operating losses for the foreseeable future, particularly if and as we:

Current wording

We have incurred operating losses since inception. Our net losses for the nine months ended September 30, 2024 and 2023 were $57.7 million and $41.1 million, respectively. As of September 30, 2024, we had an accumulated deficit of $174.1 million. These losses have resulted primarily from costs incurred in connection with research and development activities and general and administrative costs associated with our operations. We expect to continue to incur significant and increasing expenses and operating losses for the foreseeable future, particularly if and as we:

Previous wording

continue to discover and develop additional drug candidates, including ACR-2316, and drug-tailored OncoSignature tests;

Current wording

continue to discover and develop additional drug candidates and drug-tailored OncoSignature tests;

Previous wording

As of June 30, 2024, we had cash, cash equivalents and investments of $220.4 million. We believe that our existing cash, cash equivalents and investments as of June 30, 2024, will enable us to fund our operating expenses and capital expenditure requirements into the second half of 2026. 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 the section titled “—Liquidity and Capital Resources.”

Current wording

As of September 30, 2024, we had cash, cash equivalents and investments of $202.8 million. We believe that our existing cash, cash equivalents and investments as of September 30, 2024, will enable us to fund our operating expenses and capital expenditure requirements into the second half of 2026. 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 the section titled “—Liquidity and Capital Resources.”

Previous wording

Pursuant to the agreement, we paid Akoya a one-time, non-refundable, non-creditable upfront payment in the amount of $0.6 million. We are obligated to pay Akoya up to an aggregate of $17.3 million upon the achievement of specified development milestones. As of August 13, 2024, development milestones totaling $10.1 million have been achieved by Akoya under the agreement. Other than certain specified pass-through costs, each party is responsible for its own costs associated with the development of the companion diagnostic. Akoya will procure and manufacture necessary supplies to perform the ACR-368 OncoSignature test to support our clinical development and commercial requirements, in accordance with a supply agreement to be mutually agreed upon by the parties. We may terminate the agreement at our convenience, subject to the payment of a termination fee in the amount of $1.0 million.

Current wording

Pursuant to the agreement, we paid Akoya a one-time, non-refundable, non-creditable upfront payment in the amount of $0.6 million. We are obligated to pay Akoya up to an aggregate of $17.3 million upon the achievement of specified development milestones. In October 2024, we entered into the Fourth Amendment to the Akoya Agreement, or the Fourth Amendment, with Akoya, effective September 30, 2024. The Fourth Amendment added pre-commercialization progress milestones totaling $3.0 million. As of November 13, 2024, development milestones totaling $14.6 million have been achieved by Akoya under the agreement. Other than certain specified pass-through costs, each party is responsible for its own costs associated with the development of the companion diagnostic. Akoya will procure and manufacture necessary supplies to perform the ACR-368 OncoSignature test to support our clinical development and commercial requirements, in accordance with a supply agreement to be mutually agreed upon by the parties. We may terminate the agreement at our convenience, subject to the payment of a termination fee in the amount of $1.0 million.

Previous wording

direct cost for conducting internal research and development to generate preclinical validation data for ACR-368 including the ACR-368 OncoSignature, and for our internal preclinical drug discovery programs, including ACR-2316;

Current wording

direct cost for conducting internal research and development to generate preclinical validation data for ACR-368 including the ACR-368 OncoSignature, for ACR-2316, and for our internal preclinical drug discovery programs;

Previous wording

external research and development expenses incurred under agreements with CROs, as well as investigative sites and consultants that conduct our clinical trials and other scientific development services;

Current wording

external research and development expenses incurred under agreements with contract research organizations, or CROs, as well as investigative sites and consultants that conduct our clinical trials and other scientific development services;

Previous wording

The successful development of our ACR-368 and ACR-368 OncoSignature test or any other future drug candidates, including ACR-2316, is highly uncertain. We plan to substantially increase our research and development expenses for the foreseeable future as we continue the development of ACR-368 and manufacturing processes and conduct discovery and research activities for our clinical and preclinical programs, including ACR-2316 and any new programs.

Current wording

The successful development of our ACR-368 and ACR-368 OncoSignature test, ACR-2316, or any other future drug candidates, is highly uncertain. We plan to substantially increase our research and development expenses for the foreseeable future as we continue the development and manufacturing of ACR-368 and ACR-2316 and conduct discovery and research activities for our preclinical programs.

Previous wording

Any changes in the outcome of any of these variables with respect to the development of our drug candidates in clinical development could mean a significant change in the costs and timing associated with the development of these drug candidates. We may never succeed in achieving regulatory approval for any of our drug candidates. We may obtain unexpected results from our clinical trials. We may elect to discontinue, delay or modify clinical trials of some drug candidates or focus on others. For example, if the U.S. Food and Drug Administration, European Medicines Agency 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 on the completion of clinical development of that drug candidate.

Current wording

Any changes in the outcome of any of these variables with respect to the development of our drug candidates in clinical development could mean a significant change in the costs and timing associated with the development of these drug candidates. We may never succeed in achieving regulatory approval for any of our drug candidates. We may obtain unexpected results from our clinical trials. We may elect to discontinue, delay or modify clinical trials of some drug candidates or focus on others. For example, if the FDA, European Medicines Agency 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 on the completion of clinical development of that drug candidate.

Previous wording

Other expense, net primarily consists of unrealized gains and losses on foreign currency transactions, state taxes, and investment management fees.

Current wording

Other expense, net primarily consists of realized and unrealized gains and losses on foreign currency transactions, state taxes, and investment management fees.

Previous wording

a $3.2 million net increase in costs related to the continued progression of the ACR-368 clinical trial and related activities;

Current wording

a $7.1 million net increase in costs related to the continued progression of the ACR-368 clinical trial and related activities, of which $4.5 million is related to an increase in companion diagnostic milestones achieved;

Previous wording

a $1.9 million increase in personnel-related costs, including $0.2 million of stock-based compensation expense, primarily due to an increase in headcount to facilitate research activities supporting ACR-2316 and our other pipeline programs and progression of our clinical stage ACR-368 program; and

Current wording

a $0.8 million increase in personnel-related costs, including $0.1 million of stock-based compensation expense, primarily due to an increase in headcount to facilitate research activities supporting our pipeline programs and progression of our clinical stage programs.

Previous wording

General and administrative expenses were $6.4 million for the three months ended June 30, 2024, compared to $5.0 million for the three months ended June 30, 2023. The increase of $1.4 million was primarily driven by a $1.3 million increase in payroll and employee-related expenses, including $0.7 million of stock-based compensation expense.

Current wording

General and administrative expenses were $6.3 million for the three months ended September 30, 2024, compared to $5.9 million for the three months ended September 30, 2023. The increase of $0.4 million was driven by a $0.4 million increase in payroll and employee-related expenses, including $0.3 million of stock-based compensation expense.

Previous wording

Total other income, net was $2.6 million for the three months ended June 30, 2024, compared to total other income, net of $1.6 million for the three months ended June 30, 2023. The change of $1.0 million is primarily attributable to an increase in interest income and accretion earned on our investments.

Current wording

Total other income, net was $2.7 million for the three months ended September 30, 2024, compared to total other income, net of $1.7 million for the three months ended September 30, 2023. The change of $1.0 million is primarily attributable to an increase in interest income and accretion earned on our investments.

Previous wording

Research and development expenses were $26.5 million for the six months ended June 30, 2024, compared to $20.3 million for the six months ended June 30, 2023. The increase of $6.2 million was primarily due to:

Current wording

Research and development expenses were $45.4 million for the nine months ended September 30, 2024, compared to $30.5 million for the nine months ended September 30, 2023. The increase of $14.9 million was primarily due to:

Previous wording

a $4.1 million net increase in costs related to the continued progression of the ACR-368 clinical trial and related activities;

Current wording

a $11.2 million net increase in costs related to the continued progression of the ACR-368 clinical trial and related activities, of which $4.8 million is related to an increase in companion diagnostic milestones achieved;

Previous wording

a $1.0 million increase in personnel-related costs, including $0.2 million of stock-based compensation expense, primarily due to an increase in headcount to facilitate research activities supporting ACR-2316 and our other pipeline programs and progression of our clinical stage ACR-368 program.

Current wording

a $2.7 million increase in personnel-related costs, including $0.3 million of stock-based compensation expense, primarily due to an increase in headcount to facilitate research activities supporting our pipeline programs and progression of our clinical stage programs; and

Previous wording

a $0.3 million increase in facilities, supplies and other expenses, primarily due to an increase in headcount and related research activities, as well as the cessation of sublease rent income, which had been recorded as an offset to research and development expenses.

Current wording

a $0.6 million increase in facilities, supplies and other expenses, primarily due to an increase in headcount and related research activities, as well as the cessation of sublease rent income, which had been recorded as an offset to research and development expenses.

Previous wording

General and administrative expenses were $12.6 million for the six months ended June 30, 2024, compared to $9.6 million for the six months ended June 30, 2023. The increase of $3.0 million was primarily due to:

Current wording

General and administrative expenses were $18.9 million for the nine months ended September 30, 2024, compared to $15.5 million for the nine months ended September 30, 2023. The increase of $3.4 million was primarily due to:

Previous wording

a $2.4 million increase in payroll and employee-related expenses, including $1.4 million of stock-based compensation expense;

Current wording

a $2.8 million increase in payroll and employee-related expenses, including $1.7 million of stock-based compensation expense; and

Previous wording

a $0.4 million increase in facilities, supplies, and other expenses, primarily due to an increase in headcount.

Current wording

a $0.5 million increase in facilities, supplies, and other expenses, primarily due to an increase in headcount.

Previous wording

Total other income, net was $3.8 million for the six months ended June 30, 2024, compared to total other income, net of $3.2 million for the six months ended June 30, 2023. The change of $0.6 million is primarily attributable to an increase in interest income and accretion earned on our investments.

Current wording

Total other income, net was $6.5 million for the nine months ended September 30, 2024, compared to total other income, net of $4.9 million for the nine months ended September 30, 2023. The change of $1.6 million is primarily attributable to an increase in interest income and accretion earned on our investments.

Previous wording

Since our inception, we have not recognized any revenue and have incurred significant losses in each period and on an aggregate basis. We have not yet commercialized any drug candidates, and we do not expect to generate revenue from sales of any drug candidates or from other sources for several years, if at all. As of June 30, 2024, we had $220.4 million in cash, cash equivalents and investments, and we had an accumulated deficit of $151.7 million. We have funded our operations primarily with proceeds from the sales of shares of our convertible preferred stock, the issuance of convertible notes, and our IPO and concurrent private placement. Upon the closing of our IPO on November 17, 2022, only common stock remains issued and outstanding. On December 1, 2023, we filed the Registration Statement with the SEC and simultaneously entered into a sales agreement with TD Cowen, as sales agent, for the ATM Program. On April 8, 2024, we entered into the PIPE Purchase Agreement for a private placement with certain institutional and accredited investors. Pursuant to the PIPE Purchase Agreement, we agreed to issue and sell to the PIPE investors an aggregate of (i) 8,235,000 shares of our common stock at a purchase price of $8.50 per share, and (ii) Pre-Funded Warrants to purchase up to an aggregate of 7,060,000 shares of our common stock at a purchase price of $8.499 per Pre-Funded Warrant, which represents the per share purchase price of our common stock less the $0.001 per share exercise price for each Pre-Funded Warrant. The Pre-Funded Warrants are exercisable at any time after the date of issuance and do not expire. The April 2024 Private Placement closed on April 11, 2024, for aggregate net proceeds of $123.8 million, after deducting fees and expenses of $6.2 million. We believe that our existing cash, cash equivalents and investments of $220.4 million as of June 30, 2024, will enable us to fund our operating expenses and capital expenditure requirements into the second half of 2026.

Current wording

Since our inception, we have not recognized any revenue and have incurred significant losses in each period and on an aggregate basis. We have not yet commercialized any drug candidates, and we do not expect to generate revenue from sales of any drug candidates or from other sources for several years, if at all. As of September 30, 2024, we had $202.8 million in cash, cash equivalents and investments, and we had an accumulated deficit of $174.1 million. We have funded our operations primarily with proceeds from the sales of shares of our convertible preferred stock, the issuance of convertible notes, and our IPO and concurrent private placement. Upon the closing of our IPO on November 17, 2022, only common stock remains issued and outstanding. On December 1, 2023, we filed a registration statement on Form S-3, or the Registration Statement, with the SEC and simultaneously entered into a sales agreement with TD Cowen to provide for the issuance and sale of up to $100.0 million of common stock from time to time in “at-the-market” offerings under the Registration Statement and related prospectus. On April 8, 2024, we entered into the PIPE Purchase Agreement for a private placement with certain institutional and accredited investors. Pursuant to the PIPE Purchase Agreement, we agreed to issue and sell to the PIPE investors an aggregate of (i) 8,235,000 shares of our common stock at a purchase price of $8.50 per share, and (ii) Pre-Funded Warrants to purchase up to an aggregate of 7,060,000 shares of our common stock at a purchase price of $8.499 per Pre-Funded Warrant, which represents the per share purchase price of our common stock less the $0.001 per share exercise price for each Pre-Funded Warrant. The Pre-Funded Warrants are exercisable at any time after the date of issuance and do not expire. The April 2024 Private Placement closed on April 11, 2024, for aggregate net proceeds of $123.8 million, after deducting fees and expenses of $6.2 million. We believe that our existing cash, cash equivalents and investments of $202.8 million as of September 30, 2024, will enable us to fund our operating expenses and capital expenditure requirements into the second half of 2026.

Previous wording

The following table summarizes our cash flows for each of the six month periods presented (in thousands):

Current wording

The following table summarizes our cash flows for each of the nine month periods presented (in thousands):

Previous wording

Net cash used in operating activities was $31.0 million for the six months ended June 30, 2024, compared to net cash used in operating activities of $20.5 million for the six months ended June 30, 2023. The increase in net cash used in operating activities of $10.5 million was primarily driven by an increase in net loss of $8.6 million, partially offset by a $1.6 million increase in non-cash stock-based compensation expense.

Current wording

Net cash used in operating activities was $48.3 million for the nine months ended September 30, 2024, compared to net cash used in operating activities of $30.3 million for the nine months ended September 30, 2023. The increase in net cash used in operating activities of $18.0 million was primarily driven by an increase in net loss of $16.6 million, partially offset by a $2.0 million increase in non-cash stock-based compensation expense.

Previous wording

Net cash used in investing activities was $82.2 million for the six months ended June 30, 2024, resulting from purchases of short-term and long-term investments of $163.2 million and purchases of property and equipment of $1.0 million, offset by $81.9 million in proceeds from maturities of short-term investments.

Current wording

Net cash used in investing activities was $66.2 million for the nine months ended September 30, 2024, resulting from purchases of short-term and long-term investments of $168.2 million and purchases of property and equipment of $1.9 million, offset by $103.9 million in proceeds from maturities of short-term investments.

Previous wording

Net cash provided by investing activities was $28.7 million for the six months ended June 30, 2023, resulting primarily from $45.8 million in proceeds from maturities of short-term investments, offset by purchases of short-term and long-term investments of $17.0 million and purchases of property and equipment of $0.1 million.

Current wording

Net cash provided by investing activities was $30.2 million for the nine months ended September 30, 2023, resulting from $70.3 million in proceeds from maturities of short-term investments, offset by purchases of short-term and long-term investments of $39.9 million and purchases of property and equipment of $0.1 million.

Previous wording

Net cash provided by financing activities was $123.2 million for the six months ended June 30, 2024, resulting from $130.0 million in proceeds from the April 2024 Private Placement and $0.1 million in proceeds from the exercise of stock options, offset by $0.7 million of payments for tax withholdings related to the vesting of restricted stock units and $6.2 million of payments of offering costs.

Current wording

Net cash provided by financing activities was $121.7 million for the nine months ended September 30, 2024, resulting from $130.0 million in proceeds from the April 2024 Private Placement and $0.1 million in proceeds from the exercise of stock options, offset by $1.9 million of payments for tax withholdings related to the vesting of restricted stock units and $6.5 million of payments of offering costs.

Previous wording

Net cash provided by financing activities was $0.4 million for the six months ended June 30, 2023, resulting from the exercise of stock options.

Current wording

Net cash provided by financing activities was $0.5 million for the nine months ended September 30, 2023, resulting from the exercise of stock options.

Previous wording

As of June 30, 2024, our cash, cash equivalents and investments were $220.4 million. We believe that our existing cash, cash equivalents and investments as of June 30, 2024, will enable us to fund our operating expenses and capital expenditure requirements into the second half of 2026. We have based this estimate on assumptions that may prove to be wrong, and we could expend our capital resources sooner than we expect.

Current wording

As of September 30, 2024, our cash, cash equivalents and investments were $202.8 million. We believe that our existing cash, cash equivalents and investments as of September 30, 2024, will enable us to fund our operating expenses and capital expenditure requirements into the second half of 2026. We have based this estimate on assumptions that may prove to be wrong, and we could expend our capital resources sooner than we expect.

Previous wording

During the six months ended June 30, 2024, there were no material changes to our contractual obligations and commitments from those described in our Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the SEC on March 28, 2024.

Current wording

Except as discussed in Note 11 to our unaudited condensed consolidated financial statements appearing elsewhere in this Quarterly Report, during the nine months ended September 30, 2024, there were no material changes to our contractual obligations and commitments from those described in our Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the SEC on March 28, 2024.
Rearranged current paragraphs (2)

Current report — wording carried from elsewhere

continue to conduct preclinical studies and clinical trials for ACR-2316;

Current report — wording carried from elsewhere

initiate and conduct additional preclinical studies and clinical trials for ACR-2316;