Acrivon Therapeutics Inc

Previous wording

We are a clinical stage biopharmaceutical company discovering and developing next-generation precision oncology medicines that we match to patients whose tumors are predicted to be sensitive to each specific medicine by utilizing our proprietary, machine learning-enabled proteomics-based platform, AP3. 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 has been even more challenging in such diseases.

Current 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.

Previous wording

In April 2024, we presented initial positive clinical data from the ongoing registrational-intent Phase 2 ACR-368 clinical trials, which provided initial, prospective validation of the OncoSignature test’s ability to identify ovarian and endometrial patients sensitive to ACR-368 monotherapy in the ongoing clinical trial, with clear segregation of RECIST responders in the OncoSignature-positive (50% confirmed objective response rate, or ORR, in 10 patients) versus OncoSignature-negative (0% ORR in 16 patients) arms (p-value=0.0038).

Current wording

In April 2024, we presented initial positive clinical data from the ongoing registrational-intent Phase 2 ACR-368 clinical trials, which provided initial, prospective validation of the OncoSignature test’s ability to identify ovarian and endometrial patients sensitive to ACR-368 monotherapy, with clear segregation of RECIST responders in the OncoSignature-positive (50% confirmed objective response rate, or ORR, in 10 patients) versus OncoSignature-negative (0% ORR in 16 patients) arms (p-value=0.0038).

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. ACR-2316 is being rapidly advanced in IND-enabling studies, and, in April 2024, we announced new preclinical data for ACR-2316, including accelerated timelines, with IND filing now expected in Q3 2024 and the initiation of a clinical trial anticipated in Q4 2024.

Current 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.

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 studies for ACR-2316, and initiating 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 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.

Previous wording

Since inception, 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 initial public offering, or IPO, and concurrent private placement. Upon the closing of our IPO on November 17, 2022, only common stock remains issued and outstanding. In addition, on April 8, 2024, we entered into a Private Investment in Public Equity, or PIPE, securities purchase agreement, or the PIPE Purchase Agreement, for a private placement with certain institutional and accredited investors, or the April 2024 Private Placement. 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, and (ii) pre-funded warrants to purchase up to an aggregate of 7,060,000 shares of our common stock. We received $130.0 million in aggregate gross proceeds from the PIPE, before deducting the placement agent fee and other offering expenses and excluding any proceeds we may receive upon exercise of the Pre-Funded Warrants.

Current wording

Since inception, 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 initial public offering, or IPO, and concurrent private placement. Upon the closing of our IPO on November 17, 2022, only common stock remains issued and outstanding. In addition, on April 8, 2024, we entered into a Private Investment in Public Equity, or PIPE, securities purchase agreement, or the PIPE Purchase Agreement, for a private placement with certain institutional and accredited investors, or the April 2024 Private Placement. 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, or 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.

Previous wording

We have incurred operating losses since inception. Our net losses for the three months ended March 31, 2024 and 2023 were $16.5 million and $12.8 million, respectively. As of March 31, 2024, we had an accumulated deficit of $132.9 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 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:

Previous wording

As of March 31, 2024, we had cash, cash equivalents and investments of $110.0 million. We believe that our existing cash, cash equivalents and investments as of March 31, 2024, together with the gross proceeds of $130.0 million raised from the April 2024 Private Placement, 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 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.”

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 programs and continue preclinical development of ACR-2316 through IND-enabling studies.

Current 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.

Previous wording

a $0.8 million net increase in costs related to the continued progression of the ACR-368 clinical trial and related activities;

Current wording

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

Previous wording

a $0.2 million decrease 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;

Current wording

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 wording

Total other income, net was $1.2 million for the three months ended March 31, 2024, compared to total other income, net of $1.6 million for the three months ended March 31, 2023. The change of $0.4 million is primarily attributable to a decrease in interest income and accretion earned on our investments.

Current 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.

Previous wording

Research and development expenses were $11.5 million for the three months ended March 31, 2024, compared to $9.8 million for the three months ended March 31, 2023. The increase of $1.7 million was primarily due to:

Current 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:

Previous wording

a $0.9 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 ACR-2316 and our other pipeline programs and progression of our clinical stage ACR-368 program; and

Current 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

Previous wording

a $0.2 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 $0.3 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.

Previous wording

General and administrative expenses were $6.2 million for the three months ended March 31, 2024, compared to $4.6 million for the three months ended March 31, 2023. The increase of $1.6 million was primarily due to:

Current 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:

Previous wording

a $1.1 million increase in payroll and employee-related expenses, including $0.6 million of stock-based compensation expense;

Current wording

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

Previous wording

a $0.2 million increase in facilities, supplies, and other expenses, primarily due to an increase in headcount.

Current wording

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

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 March 31, 2024, we had $110.0 million in cash, cash equivalents and investments, and we had an accumulated deficit of $132.9 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. In addition, on April 8, 2024, we entered into the PIPE Purchase Agreement in which we agreed to issue and sell to the PIPE investors an aggregate of (i) 8,235,000 shares of our common stock, and (ii) pre-funded warrants to purchase up to an aggregate of 7,060,000 shares of our common stock. We received $130.0 million in aggregate gross proceeds from the PIPE, before deducting the placement agent fee and other offering expenses and excluding any proceeds we may receive upon exercise of the Pre-Funded Warrants. We believe that our existing cash, cash equivalents and investments of $110.0 million as of March 31, 2024, together with the gross proceeds of $130.0 million raised from the April 2024 Private Placement, 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 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.

Previous wording

The following table summarizes our cash flows (in thousands):

Current wording

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

Previous wording

Net cash used in operating activities was $17.1 million for the three months ended March 31, 2024, compared to net cash used in operating activities of $11.4 million for the three months ended March 31, 2023. The increase in net cash used in operating activities of $5.7 million was primarily driven by an increase in net loss of $3.7 million, partially offset by a $0.7 million increase in non-cash stock-based compensation expense.

Current 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.

Previous wording

Net cash provided by investing activities was $9.3 million for the three months ended March 31, 2023, resulting from $26.3 million in proceeds from maturities of short-term investments, offset by $17.0 million in purchases of short-term and long-term investments.

Current 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.

Previous wording

Net cash provided by investing activities was $5.9 million for the three months ended March 31, 2024, resulting from $35.0 million in proceeds from maturities of short-term investments, offset by purchases of short-term investments of $28.3 million and purchases of property and equipment of $0.8 million.

Current 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.

Previous wording

Net Cash Provided by Investing Activities

Current wording

Net Cash Provided by Financing Activities

Previous wording

Net cash used in financing activities was $0.2 million for the three months ended March 31, 2024, resulting from $0.2 million of payments for tax withholdings related to the vesting of restricted stock units and $0.1 million of payments of offering costs, offset by $0.1 million in proceeds from the exercise of stock options.

Current 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.

Previous wording

There was immaterial net cash provided by financing activities for the three months ended March 31, 2023 related to the exercise of stock options.

Current 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.

Previous wording

As of March 31, 2024, our cash, cash equivalents and investments were $110.0 million. We believe that our existing cash, cash equivalents and investments as of March 31, 2024, together with the gross proceeds of $130.0 million raised from the April 2024 Private Placement, 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 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.

Previous wording

During the three months ended March 31, 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

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.