Boundless Bio Reports First Quarter 2024 Financial Results and Corporate Highlights
Boundless Bio (Nasdaq: BOLD) reported their first quarter 2024 financial results, highlighting progress on their clinical trials. The company's Phase 1/2 POTENTIATE trial for BBI-355, a novel CHK1 inhibitor, and the Phase 1/2 STARMAP trial for BBI-825, a selective RNR inhibitor, have shown promising advancements. With a pro forma cash position of approximately $200 million following a $100 million IPO, Boundless Bio is well-positioned for future growth and development.
BBI-355 Phase 1/2 POTENTIATE trial progressing well with targeted therapy combinations in patients with EGFR or FGFR oncogene amplifications.
Initiation of Phase 1/2 STARMAP trial for BBI-825 in patients with resistance gene amplifications marks company's rapid growth.
Completed $100 million IPO resulting in a pro forma cash position of $200 million supporting the development of BBI-355 and BBI-825.
R&D expenses increased to $13.1 million primarily due to higher program costs and personnel-related expenses.
G&A expenses rose to $3.8 million mainly driven by higher personnel-related costs, stock-based compensation, and professional service fees.
Net loss increased to $15.4 million in the first quarter of 2024 compared to $11.7 million in the same period in 2023.
Insights
Boundless Bio's recent financial results exhibit a mixed picture. The pro forma cash position of approximately $200 million post-IPO is a robust indicator, suggesting ample runway for their ongoing clinical trials. The capital raise should cover operational expenses into the second half of 2026, which aligns with standard biotech funding strategies prior to reaching critical endpoints in drug development.
In terms of R&D progression, the advancement of the BBI-355 and BBI-825 agents into initial and preliminary clinical trials, respectively, is significant. The focus on oncogene amplifications positions the company within a competitive oncology market. The engagement with combination therapies reflects a current industry shift towards personalized medicine, which could enhance the therapeutic efficacy and market potential of these drugs. However, one must consider the inherent risks of clinical trials; success is not guaranteed and the path to regulatory approval is often riddled with obstacles.
The reported increase in R&D expenses by about $3.6 million year-over-year and a similar uptick in G&A expenses indicate a scaling of operations, which is expected given the transition to a clinical-stage entity. Yet, investors should monitor these expenses closely, as they reflect the burn rate and could impact the company's need for future capital raises, diluting existing shareholder value.
The net loss widening from $11.7 million to $15.4 million is usual for a company at this stage, focusing investment towards clinical development. The non-cash stock-based compensation is also a factor to be aware of, as it can have implications for earnings quality and shareholder dilution over time.
The clinical-stage development of BBI-355, a CHK1 inhibitor and BBI-825, an RNR inhibitor, could potentially introduce novel therapies into the oncology market. CHK1 and RNR are critical enzymes in DNA replication and damage response, making them promising targets for cancer therapeutics. Targeting extrachromosomal DNA (ecDNA), which often houses oncogene amplifications in cancer, is an innovative approach and showcases Boundless Bio's focus on addressing drug resistance in oncology.
Presented findings at the AACR Annual Meeting 2024 provide a glimpse into the preclinical rationale and early clinical pharmacodynamics supporting these programs. However, investors should approach these early data cautiously, as preclinical success does not always translate into clinical efficacy. Additionally, the initiation of dose escalation in combination therapies explores the potential for synergy between BBI-355 and other targeted agents, which could be a game-changer in the treatment of cancers with specific genetic alterations.
The field of cancer therapeutics is highly competitive and the eventual success of these trials could position Boundless Bio favorably within this space. However, the probability of success needs to be balanced against the long timelines and significant investments required for oncology drug development.
Boundless Bio's IPO and subsequent cash position enhancement is a strategic move, providing a buffer for their high-stakes oncology drug trials. The completion of this IPO signifies investor confidence amid a challenging healthcare market. The focus now shifts to how efficiently the company can utilize this capital to achieve critical clinical milestones.
Given the potential impact of ecDNA-targeted therapies on the treatment of intractable cancers, the success of BBI-355 and BBI-825 could open new revenue streams for Boundless Bio. However, the extended timeline until these prospects materialize into marketable products requires a patient investment outlook.
As a retail investor, the considerations around Boundless Bio should be balanced between the promising science, the execution risks inherent in clinical trials and the long road to market commercialization. A diversified portfolio strategy may mitigate the higher risk profile associated with single-asset biotech companies.
BBI-355 Phase 1/2 POTENTIATE clinical trial ongoing; initiated targeted therapy combinations in patients with tumors with EGFR or FGFR oncogene amplifications
First patient dosed in Phase 1/2 STARMAP clinical trial of BBI-825 in patients with tumors with resistance gene amplifications
Completed
“It has been an exciting quarter at Boundless Bio. The Phase 1/2 POTENTIATE trial of BBI-355, our potentially best-in-class, oral, selective CHK1 inhibitor, advanced into initial combination therapy modules evaluating BBI-355 together with an EGFR inhibitor or an FGFR inhibitor in patients with tumors harboring EGFR or FGFR oncogene amplifications, respectively. We also dosed the first patient with our second ecDNA-directed therapy (ecDTx), BBI-825, a first-in-class, oral, selective RNR inhibitor, which marks the company’s rapid growth and transition into a multi-asset, clinical-stage oncology company” said Zachary Hornby, President and Chief Executive Officer of Boundless Bio. “With the completion of our recent IPO, we have the capital to take the next steps toward delivering on the promise of our ecDTx, a potential new vertical in cancer therapeutics.”
Recent Highlights
BBI-355, a novel CHK1 inhibitor and the first ecDTx in development
- Patient enrollment is ongoing in Part 1 of the Phase 1/2 POTENTIATE (Precision Oncology Trial Evaluating Novel Therapeutic Interrupting Amplifications Tied to ecDNA) trial, which evaluates BBI-355 as a single agent in patients with locally advanced or metastatic solid tumors with oncogene amplifications.
- Initiated dose escalation in Part 2 of the Phase 1/2 POTENTIATE trial, which evaluates BBI-355 in combination with the EGFR inhibitor erlotinib and BBI-355 in combination with the FGFR inhibitor futibatinib in patients with tumors harboring EGFR or FGFR oncogene amplifications, respectively, to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of each combination regimen.
- Presented preliminary preclinical and clinical pharmacodynamic data on BBI-355 at the American Association for Cancer Research (AACR) Annual Meeting 2024. Findings further support the development of BBI-355 as a differentiated single agent and combination treatment approach for oncogene amplified cancers.
BBI-825, a novel, selective RNR inhibitor targeting ecDNA assembly and repair
- Dosed the first patient in the STARMAP (Study Targeting Acquired Resistance: MAPK Amplifications) trial, a first-in-human, Phase 1/2 study of BBI-825 as a single agent and in combination with select targeted cancer therapies, for patients with locally advanced or metastatic cancer with resistance gene amplifications.
First Quarter 2024 Financial Highlights
-
Cash Position: Cash, cash equivalents, and short-term investments totaled
$104.9 million $100.0 million
-
R&D Expenses: Research and development (R&D) expenses were
$13.1 million $9.5 million $1.8 million $0.5 million $0.3 million $1.0 million
-
G&A Expenses: General and administrative (G&A) expenses were
$3.8 million $2.6 million $0.3 million $0.5 million $0.2 million $0.2 million
-
Net Loss: Net loss totaled
$15.4 million $11.7 million $1.3 million $0.6 million
About BBI-355
Boundless Bio’s lead ecDNA-directed therapy (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 (NCT05827614) in patients with oncogene amplified cancers. CHK1 is a master regulator of cells’ response to replication stress (RS). RS is elevated in ecDNA-enabled oncogene amplified cancer cells and, because of this, represents a key vulnerability of those cells. BBI-355 was designed to exploit the elevated RS in ecDNA-enabled oncogene amplified cancer cells by disrupting proper CHK1 function in regulating RS and thereby facilitating catastrophic RS to preferentially kill cancer cells relative to healthy cells.
About BBI-825
Boundless Bio’s 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 (NCT06299761) in cancer patients with resistance gene amplifications. In preclinical studies, BBI-825 demonstrated low double digit nanomolar RNR inhibition and tumor growth inhibition, including regressions, in both the prevention and treatment of amplification-mediated resistance in mitogen-activated protein kinase (MAPK) pathway-activated tumors. RNR is the rate-limiting enzyme responsible for cellular de novo synthesis of deoxynucleotide triphosphates (dNTPs), the building blocks of DNA, and is essential to the assembly and repair of ecDNA. BBI-825 was shown to dysregulate ecDNA-reliant cancer cell dNTP pools, deplete ecDNA, and was synthetic lethal in multiple oncogene amplified preclinical cancer models.
About Boundless Bio
Boundless Bio is a clinical-stage oncology company dedicated to unlocking a new paradigm in cancer therapeutics to address the significant unmet need of patients with oncogene amplified tumors by targeting extrachromosomal DNA (ecDNA), a root cause of oncogene amplification observed in more than
For more information, visit www.boundlessbio.com.
Forward-Looking Statements
Boundless Bio cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include but are not limited to: the sufficiency of our cash position to fund operations and milestones; and the potential therapeutic benefits of our ecDTx in treating patients with oncogene amplified cancers. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: we are early in our development efforts and our approach to discover and develop ecDTx directed against ecDNA in oncogene amplified cancers is novel and unproven; results from preclinical studies or early clinical trials not necessarily being predictive of future results; potential delays in the commencement, enrollment, data readouts or completion of clinical trials or preclinical studies; our dependence on third parties in connection with clinical trials, preclinical studies, ecDNA diagnostic development, and manufacturing; unfavorable results from clinical trials or preclinical studies; unexpected adverse side effects or inadequate efficacy of our ecDTx that may limit their development, regulatory approval, and/or commercialization; the potential for our programs and prospects to be negatively impacted by developments relating to our competitors, including the results of studies or regulatory determinations relating to our competitors; regulatory developments in
BOUNDLESS BIO, INC. Condensed Statements of Operations (unaudited) (In thousands, except per share amounts) |
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Three Months Ended
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|
2024 |
|
|
2023 |
|
|||
Operating expenses: |
|
|
|
|
|
|
||
Research and development |
|
$ |
13,129 |
|
|
$ |
9,503 |
|
General and administrative |
|
|
3,754 |
|
|
|
2,584 |
|
Total operating expenses |
|
|
16,883 |
|
|
|
12,087 |
|
Loss from operations |
|
|
(16,883 |
) |
|
|
(12,087 |
) |
Other income (expense): |
|
|
|
|
|
|
||
Interest income |
|
|
1,421 |
|
|
|
395 |
|
Other income (expense) |
|
|
32 |
|
|
|
(27 |
) |
Total other income, net |
|
|
1,453 |
|
|
|
368 |
|
Net loss |
|
$ |
(15,430 |
) |
|
$ |
(11,719 |
) |
|
|
|
|
|
|
|
||
Net loss per share, basic and diluted |
|
$ |
(12.27 |
) |
|
$ |
(9.91 |
) |
Shares used in calculation |
|
|
1,258 |
|
|
|
1,183 |
|
BOUNDLESS BIO, INC. Condensed Balance Sheets (In thousands, except par value data) |
||||||||
|
|
March 31,
|
|
|
December 31,
|
|
||
|
|
(unaudited) |
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|
|
|
||
Assets |
|
|
|
|
|
|
||
Current assets |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
25,143 |
|
|
$ |
23,706 |
|
Short-term investments |
|
|
79,737 |
|
|
|
97,046 |
|
Prepaid expenses and other current assets |
|
|
7,281 |
|
|
|
3,452 |
|
Total current assets |
|
|
112,161 |
|
|
|
124,204 |
|
Property and equipment, net |
|
|
2,418 |
|
|
|
2,573 |
|
Right-of-use asset, net |
|
|
1,385 |
|
|
|
2,002 |
|
Restricted cash |
|
|
560 |
|
|
|
560 |
|
Other assets |
|
|
553 |
|
|
|
555 |
|
Total assets |
|
$ |
117,077 |
|
|
$ |
129,894 |
|
Liabilities, convertible preferred stock, and stockholders’ deficit |
|
|
|
|
|
|
||
Current liabilities |
|
|
|
|
|
|
||
Accounts payable and accrued liabilities |
|
$ |
8,182 |
|
|
$ |
4,266 |
|
Accrued compensation |
|
|
939 |
|
|
|
2,898 |
|
Lease liabilities, current portion |
|
|
1,523 |
|
|
|
2,195 |
|
Total current liabilities |
|
|
10,644 |
|
|
|
9,359 |
|
Convertible preferred stock |
|
|
247,617 |
|
|
|
247,617 |
|
Stockholders’ equity: |
|
|
|
|
|
|
||
Common stock, |
|
|
— |
|
|
|
— |
|
Additional paid-in-capital |
|
|
10,376 |
|
|
|
8,987 |
|
Accumulated other comprehensive income / (loss) |
|
|
(21 |
) |
|
|
40 |
|
Accumulated deficit |
|
|
(151,539 |
) |
|
|
(136,109 |
) |
Total stockholders’ deficit |
|
|
(141,184 |
) |
|
|
(127,082 |
) |
Total liabilities, convertible preferred stock, and stockholders’ deficit |
|
$ |
117,077 |
|
|
$ |
129,894 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20240511206618/en/
James Lee, Boundless Bio
jlee@boundlessbio.com
Investors
THRUST Strategic Communications
Renee Leck
renee@thrustsc.com
Media
1AB
Dan Budwick
dan@1abmedia.com
Source: Boundless Bio
FAQ
What is the stock symbol of Boundless Bio?
The stock symbol of Boundless Bio is BOLD.
What trials are ongoing at Boundless Bio?
Boundless Bio is conducting the Phase 1/2 POTENTIATE trial for BBI-355 and the Phase 1/2 STARMAP trial for BBI-825.
What was the gross proceeds from Boundless Bio's IPO?
Boundless Bio raised $100 million in gross proceeds from their IPO.
What was Boundless Bio's cash position as of March 31, 2024?
Boundless Bio had a cash position of $104.9 million as of March 31, 2024.
How long can Boundless Bio's current cash position fund operations?
Boundless Bio expects its current cash position to fund operations into the second half of 2026 and through key clinical data milestones.
