Boundless Bio Inc

Previous wording

This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act). All statements other than statements of historical facts contained in this Quarterly Report, including statements regarding our future results of operations and financial position, business strategy, research and development plans, the anticipated timing, costs, design, and conduct of our ongoing and planned clinical trials and preclinical studies for our extrachromosomal DNA (ecDNA) directed therapeutic candidates (ecDTx), ecDNA diagnostic candidate, and other development programs, the potential therapeutic benefits of our ecDTx, the timing and likelihood of regulatory filings and approvals for our ecDTx, our ability to commercialize our ecDTx, if approved, the pricing and reimbursement of our ecDTx, if approved, the potential to develop future ecDTx, the potential benefits of strategic collaborations and our intent to enter into any strategic arrangements, the timing and likelihood of success, plans, and objectives of management for future operations, future results of anticipated ecDTx development efforts, and the sufficiency of our cash position to fund operations and milestones, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements.

Current wording

This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act). All statements other than statements of historical facts contained in this Quarterly Report, including statements regarding our future results of operations and financial position, business strategy, research and development plans, the anticipated timing, costs, design, and conduct of our ongoing and planned clinical trials and preclinical studies for our extrachromosomal DNA (ecDNA) directed therapeutic candidates (ecDTx), ecDNA diagnostic candidate, our other discovery program, the timing of expected data readouts, the impact on our cash runway of our streamlining efforts and the sufficiency of our cash position and such efforts to fund operations and initial clinical proof-of-concept data readouts, the potential safety and therapeutic benefits of our ecDTx, the timing and likelihood of regulatory filings and approvals for our ecDTx, our ability to commercialize our ecDTx, if approved, the pricing and reimbursement of our ecDTx, if approved, the potential to develop future ecDTx, the potential benefits of strategic collaborations and our intent to enter into any strategic arrangements, the timing and likelihood of success, plans, and objectives of management for future operations, future results of anticipated ecDTx development efforts, and the sufficiency of our cash position to fund operations and milestones, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements.

Previous wording

Our lead ecDTx, BBI-355, is a novel, oral, selective small molecule inhibitor of checkpoint kinase 1 (CHK1) being studied in the ongoing first-in-human, Phase 1/2 POTENTIATE clinical trial in patients with oncogene amplified cancers (clinicaltrials.gov identifier NCT05827614). We expect to have preliminary clinical proof of concept safety and antitumor activity data of BBI-355 as a single agent and in combination with targeted therapies in the second half of 2024 from approximately 50 to 90 total enrolled patients (single agent cohorts N=~30 to 40, combination cohorts N=~20 to 50).

Current wording

Our lead ecDTx, BBI-355, is a novel, oral, selective small molecule inhibitor of checkpoint kinase 1 (CHK1) being studied in the ongoing first-in-human, Phase 1/2 POTENTIATE clinical trial in patients with oncogene amplified cancers (clinicaltrials.gov identifier NCT05827614). As of July 22, 2024, no new safety signals have been observed, and there has been no evidence of combinatorial toxicity in the dose escalation cohorts evaluating BBI-355 in combination with either the EGFR inhibitor erlotinib or the FGFR inhibitor futibatinib. The initial pace of enrollment in the combination cohorts has been slower than anticipated. We have recently implemented multiple initiatives to help accelerate enrollment, including engaging with next-generation sequencing vendors to identify potential patients, adding new clinical sites in the United States, and preparing for the initiation of ex-U.S. sites. Based on current projections, we expect to have preliminary clinical proof-of-concept safety and antitumor activity data from the POTENTIATE trial in the second half of 2025.

Previous wording

Our second ecDTx, BBI-825, is a novel, oral, selective small molecule inhibitor of ribonucleotide reductase (RNR) being studied in the ongoing first-in-human, Phase 1/2 STARMAP clinical trial in patients with resistance gene amplifications (clinicaltrials.gov identifier NCT06299761). We expect to have preliminary clinical proof of concept safety and antitumor data of BBI-825 in combination with targeted therapies in the second half of 2025.

Current wording

Our second ecDTx, BBI-825, is a novel, oral, selective small molecule inhibitor of ribonucleotide reductase (RNR) being studied in the ongoing first-in-human, Phase 1/2 STARMAP clinical trial in colorectal cancer patients with BRAF V600E or KRAS G12C mutations and resistance oncogene amplifications (clinicaltrials.gov identifier NCT06299761). Multiple dose levels have been completed in the single-agent, dose-escalation portion of the trial and, to date, BBI-825 has demonstrated oral bioavailability and has been generally well-tolerated. We expect to have preliminary clinical proof-of-concept safety and antitumor data from the STARMAP trial in the second half of 2025.

Previous wording

We continue to leverage Spyglass to identify and preclinically validate additional ecDNA-essential targets. In addition to our three ecDTx programs described above, we have preclinically validated multiple additional ecDNA targets and have initiated ecDTx drug discovery efforts to identify candidates against such targets. We expect to continue to identify and preclinically validate additional ecDNA targets using our Spyglass platform in the future. To date, all of our ecDTx have been discovered internally, and we retain global rights for all of our programs.

Current wording

Through our Spyglass platform, we are able to identify and preclinically validate additional ecDNA-essential targets. In addition to our three ecDTx programs described above, we have preclinically validated multiple additional ecDNA targets and have initiated ecDTx drug discovery efforts to identify candidates against such targets. To date, all of our ecDTx have been discovered internally, and we retain global rights for all of our programs.

Previous wording

To assist in identifying patients that may benefit from our ecDTx, we have developed an ecDNA diagnostic test, internally called ECHO (ecDNA Harboring Oncogenes), to detect ecDNA in patient tumor samples via routine next generation sequencing (NGS) assays. We are working with anin vitro diagnostic company to develop the ecDNA diagnostic into a clinical trial assay, which we intend to use in our ongoing Phase 1/2 POTENTIATE clinical trial. The U.S. Food and Drug Administration (FDA) has determined that the ecDNA diagnostic is a non-significant risk device when used in patient selection for the POTENTIATE trial, meaning that we will not be required to obtain FDA approval of an investigational device exemption for the use of the ecDNA diagnostic in this trial.

Current wording

To assist in identifying patients that may benefit from our ecDTx, we have developed an ecDNA diagnostic test, internally called ECHO (ecDNA Harboring Oncogenes), to detect ecDNA in patient tumor samples via routine next generation sequencing (NGS) assays. In partnership with an in vitro diagnostic company, we developed and analytically validated the ecDNA diagnostic for use as a clinical trial assay in the PONTENTIATE trial. The U.S. Food and Drug Administration (FDA) has determined that the ecDNA diagnostic is a non-significant risk device when used in patient selection for the POTENTIATE trial, meaning that we will not be required to obtain FDA approval of an investigational device exemption for the use of the ecDNA diagnostic in this trial. Additionally, we have received institutional review board approval to use the ecDNA diagnostic in the POTENTIATE trial.

Previous wording

We have incurred significant operating losses since our inception and, as of March 31, 2024, we had an accumulated deficit of $151.5 million. We expect to continue to incur losses for the foreseeable future, and we anticipate these losses will increase substantially as we continue our development of, seek regulatory approval for, and potentially commercialize any of our ecDTx and seek to discover and develop additional ecDTx, develop our ecDNA diagnostic, conduct our ongoing and planned clinical trials and preclinical studies, continue our research and development activities, utilize third parties to manufacture our ecDTx and related raw materials, hire additional personnel, expand and protect our intellectual property, as well as incur additional costs associated with being a public company. If we obtain regulatory approval for any of our ecDTx, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing, and distribution. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials, preclinical studies, and our other research and development activities and capital expenditures.

Current wording

We have incurred significant operating losses since our inception and, as of June 30, 2024, we had an accumulated deficit of $168.5 million. We expect to continue to incur losses for the foreseeable future, and anticipate these losses will increase substantially as we continue our development of, seek regulatory approval for, and potentially commercialize any of our ecDTx and seek to discover and develop additional ecDTx, develop our ecDNA diagnostic, conduct our ongoing and planned clinical trials and preclinical studies, continue our research and development activities, utilize third parties to manufacture our ecDTx and related raw materials, hire additional personnel, expand and protect our intellectual property, as well as incur additional costs associated with being a public company. If we obtain regulatory approval for any of our ecDTx, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing, and distribution. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials, preclinical studies, and our other research and development activities and capital expenditures.

Previous wording

Through March 31, 2024, we have raised a total of $253.6 million to fund our operations primarily from the gross proceeds from the sale and issuance of our convertible preferred stock. As of March 31, 2024, we had cash, cash equivalents, and short-term investments of $104.9 million. In April 2024, we completed our IPO pursuant to which we sold 6,250,000 shares of our common stock for gross proceeds of $100.0 million. Based upon our current operating plans, we believe that our existing cash, cash equivalents, and short-term investments, together with the net proceeds from our IPO, will be sufficient to fund our operations into the second half of 2026.

Current wording

In April 2024, we completed our initial public offering (IPO) pursuant to which we sold 6,250,000 shares of our common stock for gross proceeds of $100.0 million. Through June 30, 2024, we have raised a total of $353.6 million to fund our operations primarily from the gross proceeds from the sale and issuance of our convertible preferred stock and from our IPO. As of June 30, 2024, we had cash, cash equivalents, and short-term investments of $179.3 million. In August 2024, we announced our intention to scale back our early discovery efforts, including a modest reduction in workforce, to extend our operating runway. Based upon our current operating plans, we believe that our existing cash, cash equivalents, and short-term investments will be sufficient to fund our operations into the fourth quarter of 2026.

Previous wording

Other income, net was $1.5 million and $0.4 million for the three months ended March 31, 2024 and 2023, respectively. The $1.1 million increase resulted from the additional interest income generated by our available-for-sale investment securities portfolio due to the net proceeds from the sale of shares of our Series C convertible preferred stock in April and May 2023, as well as the increase in market yields available for such investment securities in comparison to the prior year period.

Current wording

Other income, net was $2.4 million and $1.6 million for the three months ended June 30, 2024 and 2023, respectively. The $0.9 million increase resulted from the additional interest income generated by our available-for-sale investment securities portfolio due to the net proceeds from the sale of our common stock in our IPO in April 2024, as well as the increase in market yields available for such investment securities in comparison to the prior year period.

Previous wording

R&D expenses were $13.1 million for the first quarter of 2024, compared to $9.5 million for the same period in 2023. Growth in our R&D expenses was primarily due to a $1.8 million increase in the direct program costs for our BBI-355, BBI-825, and other development programs, a $0.5 million increase in personnel-related costs resulting from an increase in headcount and salary increases, $0.3 million of additional stock-based compensation, and a $1.0 million increase in third-party services and other miscellaneous R&D costs.

Current wording

R&D expenses were $27.9 million for the six months ended June 30, 2024, compared to $20.6 million for the same period in 2023. The increase in R&D expenses was primarily due to a $4.4 million increase in the direct program costs for our BBI-355, BBI-825, and other development programs, a $1.3 million increase in personnel-related costs resulting from an increase in headcount and salary increases, $0.7 million of additional stock-based compensation, and a $0.9 million increase in third-party services and other miscellaneous R&D costs.

Previous wording

G&A expenses were $3.8 million for the first quarter of 2024, compared to $2.6 million for the same period in 2023. The increase in G&A expenses was primarily due to a $0.3 million increase in personnel-related costs due to an increase in headcount and salary increases, $0.5 million of additional stock-based compensation, an increase in professional service fees of $0.2 million, and a $0.2 million increase in other G&A costs.

Current wording

G&A expenses were $8.4 million for the six months ended June 30, 2024, compared to $5.5 million for the same period in 2023. The increase in G&A expenses was primarily due to a $0.7 million increase in personnel-related costs due to an increase in headcount and salary increases, $1.2 million of additional stock-based compensation, an increase in professional service fees of $0.4 million, and a $0.6 million increase in other G&A costs.

Previous wording

Through March 31, 2024, we have raised a total of $253.6 million to fund our operations primarily from the gross proceeds from the sale and issuance of our convertible preferred stock. In April 2024, we completed our IPO pursuant to which we sold 6,250,000 shares of our common stock for gross proceeds of $100.0 million.

Current wording

Through June 30, 2024, we have raised a total of $353.6 million to fund our operations primarily from the gross proceeds from the sale and issuance of our convertible preferred stock and the sale and issuance of 6,250,000 shares of our common stock in our IPO in April 2024 for gross proceeds of $100.0 million.

Previous wording

As of March 31, 2024, we had cash, cash equivalents, and short-term investments of $104.9 million. Based upon our current operating plans, we believe that the net proceeds from our IPO, together with our existing cash, cash equivalents, and short-term investments, will be sufficient to fund our operations into the second half of 2026. However, our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. We have based this estimate on assumptions that may prove to be wrong, and we could deplete our capital resources sooner than we expect. Additionally, the process of conducting preclinical studies, manufacturing ecDTx, developing our ecDNA diagnostic, and testing ecDTx in clinical trials is costly, and the timing of progress and expenses in these studies and trials is uncertain.

Current wording

As of June 30, 2024, we had cash, cash equivalents, and short-term investments of $179.3 million. Based upon our current operating plans, we believe that our existing cash, cash equivalents, and short-term investments will be sufficient to fund our operations into the fourth quarter of 2026. However, our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. We have based this estimate on assumptions that may prove to be wrong, and we could deplete our capital resources sooner than we expect. Additionally, the process of conducting preclinical studies, manufacturing ecDTx, developing our ecDNA diagnostic, and testing ecDTx in clinical trials is costly, and the timing of progress and expenses in these studies and trials is uncertain.

Previous wording

We have incurred significant operating losses since our inception and, as of March 31, 2024, we had an accumulated deficit of $151.5 million. We expect to continue to incur losses for the foreseeable future, and we anticipate these losses will increase substantially as we continue our development of, seek regulatory approval for, and potentially commercialize any of our ecDTx and seek to discover, and develop additional ecDTx, conduct our ongoing and planned clinical trials and preclinical studies, continue our research and development activities, utilize third parties to manufacture our ecDTx and related raw materials, seek to develop our ecDNA diagnostic, hire additional personnel, expand and protect our intellectual property, as well as incur additional costs associated with being a public company. If we obtain regulatory approval for any of our ecDTx, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing, and distribution. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials and preclinical studies and our other research and development activities and capital expenditures.

Current wording

We have incurred significant operating losses since our inception and, as of June 30, 2024, we had an accumulated deficit of $168.5 million. We expect to continue to incur losses for the foreseeable future, and we anticipate these losses will increase substantially as we continue our development of, seek regulatory approval for, and potentially commercialize any of our ecDTx and seek to discover, and develop additional ecDTx, conduct our ongoing and planned clinical trials and preclinical studies, continue our research and development activities, utilize third parties to manufacture our ecDTx and related raw materials, seek to develop our ecDNA diagnostic, hire additional personnel, expand and protect our intellectual property, as well as incur additional costs associated with being a public company. If we obtain regulatory approval for any of our ecDTx, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing, and distribution. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials and preclinical studies and our other research and development activities and capital expenditures.

Previous wording

Net cash used in operating activities was $15.8 million and $12.1 million for the three months ended March 31, 2024 and 2023, respectively. The net cash used in operating activities during the three months ended March 31, 2024 was primarily due to our reported net loss of $15.4 million, net of noncash charges (including stock-based compensation expense, depreciation, and right-of-use asset amortization) totaling $1.2 million and a $1.6 million decrease of our net operating assets. The net cash used in operating activities during the three months ended March 31, 2023 was primarily due to our reported net loss of $11.7 million and a $1.7 million increase in our net operating assets, adjusted for noncash charges (including stock-based compensation expense, depreciation) totaling $1.3 million. The increase in cash used in operations during the three months ended March 31, 2024 in comparison to the three months ended March 31, 2024 was primarily attributable to higher personnel-related costs and an increase in third-party spending associated with our discovery, development, and clinical activities.

Current wording

Net cash used in operating activities was $32.0 million and $23.0 million for the six months ended June 30, 2024 and 2023, respectively. The net cash used in operating activities during the six months ended June 30, 2024 was primarily due to our reported net loss of $32.4 million, net of noncash charges (including stock-based compensation expense, depreciation, and right-of-use asset amortization) totaling $2.6 million and a $2.2 million increase of our net operating assets. The net cash used in operating activities during the six months ended June 30, 2023 was primarily due to our reported net loss of $24.1 million and a $1.2 million increase in our net operating assets, adjusted for noncash charges (including stock-based compensation expense, depreciation) totaling $2.3 million. The increase in cash used in operations during the six months ended June 30, 2024 in comparison to the six months ended June 30, 2024 was primarily attributable to higher personnel-related costs and an increase in third-party spending associated with our discovery, development, and clinical activities.

Previous wording

Investing activities consist primarily of the cash flows of purchases and maturities of investment securities and the cash outflow associated with purchases of property and equipment. Such activities resulted in a net inflow of funds of approximately $18.1 million during the three months ended March 31, 2024, primarily from the net maturities of our available-for-sale securities portfolio, and a net inflow of funds of $22.2 million during the three months ended March 31, 2023, primarily from net maturities of available-for-sale securities portfolio.

Current wording

Investing activities consist primarily of the cash flows of purchases and maturities of investment securities and the cash outflow associated with purchases of property and equipment. Such activities resulted in a net outflow of funds of approximately $50.1 million during the six months ended June 30, 2024, primarily from the net purchases of our available-for-sale securities portfolio, and a net outflow of funds of $46.4 million during the six months ended June 30, 2023, primarily from net maturities of available-for-sale securities portfolio.

Previous wording

Our financing activities consist of the proceeds from the exercise of common stock options by our employees and consultants. Net cash provided by / (used in) financing activities was ($924,000) and $31,000 during the three months ended March 31, 2024 and 2023, respectively. The change in cash used by financing activities for the first three months of 2024 was primarily due to payments made for deferred offering costs related to our IPO. The increase in cash provided by financing activities for the first three months of 2023 was the result of the exercise of common stock options by our employees and consultants.

Current wording

Our financing activities consist of the proceeds from sales of common and preferred stock and, to a lesser extent, the exercise of common stock options by our employees and consultants. Net cash provided by financing activities was $89.7 million and $99.7 million during the six months ended June 30, 2024 and 2023, respectively. The increase in cash provided by financing activities for the first six months of 2024 was primarily due to the net proceeds from our IPO. The increase in cash provided by financing activities for the first six months of 2023 was primarily the result of the net proceeds from the sale of our Series C convertible preferred stock.

Previous wording

We lease office and lab space under lease agreements with varying expiration dates through 2034. As of March 31, 2024, total future aggregate operating lease commitments was $73.5 million. During the normal course of our business, we enter into contracts for research and professional services, and for the purchase of lab supplies used in our research activities. These contracts generally provide for termination after a notice period, and, therefore, are cancelable contracts and not separately presented.

Current wording

We lease office and lab space under lease agreements with varying expiration dates through 2034. As of June 30, 2024, total future aggregate operating lease commitments was $72.8 million. During the normal course of our business, we enter into contracts for research and professional services, and for the purchase of lab supplies used in our research activities. These contracts generally provide for termination after a notice period, and, therefore, are cancelable contracts and not separately presented.