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Bolt Biotherapeutics Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Business Update

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Bolt Biotherapeutics (Nasdaq: BOLT) reports positive progress in Phase 2 studies for BDC-1001 and successful safety assessments for BDC-3042. The company's cash balance of $128.6 million as of December 31, 2023, is expected to fund key milestones through late 2025.
Positive
  • Successful advancement in Phase 2 studies for BDC-1001 (trastuzumab imbotolimod) across four HER2-positive tumor types.
  • BDC-3042 Phase 1 study clears safety assessments in the first three dose level cohorts.
  • Cash balance of $128.6 million as of December 31, 2023, expected to fund key milestones through late 2025.
  • Collaboration revenue increases to $2.1 million for the quarter and $7.9 million for the full year ended December 31, 2023.
  • Research and Development (R&D) expenses decrease to $16.3 million for the quarter and $61.5 million for the full year ended December 31, 2023.
  • General and Administrative (G&A) expenses decrease to $5.5 million for the quarter and $22.5 million for the full year ended December 31, 2023.
  • Loss from operations decreases to $19.8 million for the quarter and $76.2 million for the full year ended December 31, 2023.
Negative
  • None.

The progress of Bolt Biotherapeutics in advancing their Phase 2 studies for BDC-1001, now known as trastuzumab imbotolimod, marks a pivotal stage in the clinical development of new cancer treatments. The reported objective response rate (ORR) of 29% at the ESMO 2023 Congress, including one complete response and three partial responses, suggests a potentially promising efficacy profile for this novel immunotherapy. However, the impact on the company's valuation will depend on the consistency of these results across a larger patient population and longer-term data on survival outcomes.

Moreover, the successful clearance of safety assessments for the Phase 1 study of BDC-3042 is a important step forward in the drug's development pathway. As it targets Dectin-2, a receptor on tumor-associated macrophages, this therapy could represent a novel mechanism of action in the immunotherapy landscape. The absence of dose-limiting toxicities thus far is encouraging for its safety profile. Investors should note that the combination therapy with a PD-1 inhibitor could enhance the therapeutic potential of BDC-3042, but combination studies are yet to be reported.

From a financial perspective, the cash balance of $128.6 million provides the company with a runway through late 2025, which is relatively strong for a biotech firm in clinical development stages. The decrease in R&D expenses reflects efficient capital allocation and cost containment, which is often appreciated by investors. However, the true value inflection points will be the clinical trial outcomes, which have the potential to significantly affect the stock's performance.

Investors should consider the financial health and operational efficiency of Bolt Biotherapeutics as reflected in their latest earnings report. A year-over-year increase in collaboration revenue from $5.7 million to $7.9 million indicates a growing confidence in the company's research capabilities and potential for future partnerships, which can be a positive signal for future revenue streams.

The reported decrease in R&D expenses, from $73.1 million to $61.5 million, alongside a reduction in G&A expenses, suggests disciplined spending and could be viewed favorably in terms of long-term sustainability. However, the company's operational loss has decreased from $90.3 million to $76.2 million, which, while still significant, indicates an improvement in managing operational costs.

Strategic partnerships, such as the one with Roche providing pertuzumab, could also be a lever for risk-sharing and capital efficiency. The financial runway extending into late 2025 allows for continued investment in key clinical milestones without the immediate need for additional capital raises, which could dilute existing shareholders' stakes.

Trastuzumab imbotolimod's advancement into later-stage clinical trials is noteworthy, particularly for the treatment of HER2-positive cancers. HER2 is a protein that can promote the growth of cancer cells. Inhibiting this protein can be an effective treatment strategy, as seen with other HER2-targeted therapies. The combination of trastuzumab imbotolimod with pertuzumab could potentially offer a more comprehensive blockade of HER2 signaling pathways, which may translate to better clinical outcomes for patients with metastatic breast cancer.

The use of a Simon two-stage design in the Phase 2 cohorts is a strategic approach to clinical trial design, enabling an early stop for futility if the treatment does not show promise. This can save time and resources while focusing on the most promising therapeutic avenues. The reported safety profile, with mostly low-grade infusion-related reactions, is also encouraging, as it suggests the treatment may be well-tolerated, which is always a significant consideration in cancer therapy.

–   BDC-1001 (trastuzumab imbotolimod) Phase 2 studies in four HER2-positive tumor types advancing toward 2024 milestones
–   BDC-3042 Phase 1 study successfully cleared safety assessments in the first three dose level cohorts
–   Cash balance of $128.6 million as of December 31, 2023, anticipated to fund key milestones through late 2025

REDWOOD CITY, Calif., March 21, 2024 (GLOBE NEWSWIRE) --  Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.

“We made substantial progress advancing our two proprietary clinical-stage development programs in 2023,” said Randall Schatzman, Ph.D., Chief Executive Officer. “We have now administered BDC-1001, which we have renamed trastuzumab imbotolimod, to patients in all five of the Phase 2 cohorts. BDC-3042 also continues to advance, and has now entered the fourth dose escalation cohort without a dose-limiting toxicity. Both clinical programs are on track and we look forward to providing updates later this year.”

Recent Highlights and Anticipated Milestones

  • Trastuzumab imbotolimod (BDC-1001) Phase 2 program continues to advance. Trastuzumab imbotolimod is a Boltbody™ ISAC that is currently in Phase 2 clinical development across five distinct cohorts treating patients with HER2-positive cancer. The first three cohorts evaluate monotherapy trastuzumab imbotolimod in colorectal, endometrial, and gastroesophageal cancer,  and the fourth and fifth cohorts evaluate trastuzumab imbotolimod with or without pertuzumab for the treatment of HER-2 positive metastatic breast cancer. All cohorts utilize a Simon two-stage design. Roche is providing pertuzumab in support of the trial.  The most recent update on trastuzumab imbotolimod was presented at the ESMO 2023 Congress in October 2023, noting a 29% objective response rate (ORR) comprising 1 complete response (CR) and 3 partial responses (PRs) in evaluable patients with HER2-positive tumors at the recommended Phase 2 dose (RP2D). BDC-1001 was well tolerated. The most common treatment-related treatment-emergent adverse events (TEAE) was Grade 1 or 2 infusion-related reactions, which were seen in 30% of patients in the study.
  • BDC-3042 Phase 1 dose escalation study continues to advance. BDC-3042 is a proprietary agonist antibody that targets Dectin-2, an immune-activating receptor expressed by tumor-associated macrophages (TAMs). This dose-escalation Phase 1 clinical study will initially evaluate BDC-3042 as monotherapy in patients with a variety of solid tumors, and will then evaluate the combination of BDC-3042 with a PD-1 inhibitor. Bolt has completed the first three dosing cohorts without observing any dose-limiting toxicities and the trial is enrolling well.
  • Cash, cash equivalents, and marketable securities were $128.6 million as of December 31, 2023. Cash on hand is expected to fund multiple clinical milestones in 2024 and operations through late 2025.

Fourth Quarter and Full Year 2023 Financial Results

  • Collaboration Revenue – Collaboration revenue was $2.1 million for the quarter and $7.9 million for the full year ended December 31, 2023, compared to $1.4 million and $5.7 million for the same quarter and year in 2022. Revenue in the comparative periods was generated from the services performed under our R&D collaborations as we fulfill our performance obligations.
     
  • Research and Development (R&D) Expenses – R&D expenses were $16.3 million for the quarter and $61.5 million for the full year ended December 31, 2023, compared to $16.8 million and $73.1 million for the same quarter and year ended 2022. The decrease in R&D expenses was due to lower manufacturing expenses related to the timing of batch production, offset by higher clinical expenses related to the advancement of trastuzumab imbotolimod clinical trial into Phase 2.
     
  • General and Administrative (G&A) Expenses – G&A expenses were $5.5 million for the quarter and $22.5 million for the full year ended December 31, 2023, compared to $5.6 million and $22.9 million for the same quarter and year in 2022.
     
  • Loss from Operations – Loss from operations was $19.8 million for the quarter and $76.2 million for the full year ended December 31, 2023, compared to $21.0 million and $90.3 million for the same quarter and year in 2022. This is in part a reflection of proactive cost-containment measures taken in June 2022.

About the Boltbody™ Immune-Stimulating Antibody Conjugate (ISAC) Platform
Bolt Biotherapeutics’ Boltbody ISAC platform harnesses the precision of antibodies with the power of the innate and adaptive immune system to reprogram the tumor microenvironment to generate a productive anti-cancer response. Each Boltbody ISAC candidate comprises a tumor-targeting antibody, a non-cleavable linker, and a proprietary immune stimulant. The antibody is designed to target one or more markers on the surface of a tumor cell and the immune stimulant is designed to recruit and activate myeloid cells. Activated myeloid cells initiate a positive feedback loop by releasing cytokines and chemokines, chemical signals that attract other immune cells and lower the activation threshold for an immune response. This increases the population of activated immune system cells in the tumor microenvironment and promotes a robust immune response with the goal of generating durable therapeutic responses for patients with cancer.

About Bolt Biotherapeutics, Inc.
Bolt Biotherapeutics is a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer. Bolt Biotherapeutics’ pipeline candidates are built on the Company’s deep expertise in myeloid biology and cancer drug development. The Company’s pipeline includes trastuzumab imbotolimod (formerly BDC-1001), a HER2-targeting Boltbody™ Immune-Stimulating Antibody Conjugate (ISAC), BDC-3042, a myeloid-modulating antibody, and multiple Boltbody ISAC collaboration programs. Trastuzumab imbotolimod is currently in Phase 2 clinical development following the successful completion of a Phase 1 dose-escalation trial that demonstrated tolerability and early clinical efficacy. BDC-3042, an agonist antibody targeting Dectin-2, is currently in a Phase 1 dose-escalation trial. In preclinical development, BDC-3042 demonstrated the ability to convert tumor-supportive macrophages to tumor-destructive macrophages. Bolt Biotherapeutics is also developing multiple Boltbody™ ISACs in strategic collaborations with leading biopharmaceutical companies. For more information, please visit https://www.boltbio.com/

Forward-Looking Statements
This press release contains forward-looking statements about us and our industry that involve substantial risks and uncertainties and are based on our beliefs and assumptions and on information currently available to us. All statements other than statements of historical facts contained in this press release, including statements regarding the advancement and success of our clinical trials, the timing of future updates from our clinical programs, the potential profile of BDC-1001 and BDC-3042,  the potential benefits of combining BDC-1001 with pertuzumab, and our expectation that our cash on hand will fund multiple milestones and operations through late 2025, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “on track,” “plan,” “potential,” “predict,” “project,” “should,” “will,” or “would,” or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other 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. Forward-looking statements represent our current beliefs, estimates and assumptions only as of the date of this press release and information contained in this press release should not be relied upon as representing our estimates as of any subsequent date. These statements, and related risks, uncertainties, factors and assumptions, include, but are not limited to: the potential product candidates that we develop may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release; such product candidates may not be beneficial to patients or become commercialized; and our ability to maintain our current collaborations and establish further collaborations. These risks are not exhaustive. Except as required by law, we assume no obligation to update these forward-looking statements, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. Further information on factors that could cause actual results to differ materially from the results anticipated by our forward-looking statements is included in the reports we have filed or will file with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2023. These filings, when available, are available on the investor relations section of our website at investors.boltbio.com and on the SEC’s website  at www.sec.gov.

Investor Relations and Media Contact:    
Matthew DeYoung
Argot Partners
(212) 600-1902
boltbio@argotpartners.com



BOLT BIOTHERAPEUTICS, INC.
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share amounts)
   
  For The Three Months Ended December 31,  Years Ended December 31, 
  2023  2022  2023  2022 
Collaboration revenue $2,089  $1,411  $7,876  $5,729 
Operating expenses:            
Research and development  16,322   16,845   61,542   73,123 
General and administrative  5,533   5,606   22,530   22,927 
Total operating expense  21,855   22,451   84,072   96,050 
Loss from operations  (19,766)  (21,040)  (76,196)  (90,321)
Other income, net            
Interest income  1,863   1,043   6,999   2,223 
Total other income, net  1,863   1,043   6,999   2,223 
Net loss  (17,903)  (19,997)  (69,197)  (88,098)
Net unrealized gain (loss) on marketable securities  211   790   956   (598)
Comprehensive loss $(17,692) $(19,207) $(68,241) $(88,696)
Net loss per share, basic and diluted $(0.47) $(0.53) $(1.83) $(2.36)
Weighted-average shares outstanding, basic and diluted  37,941,587   37,552,208   37,811,984   37,358,425 



BOLT BIOTHERAPEUTICS, INC.
BALANCE SHEETS
(In thousands)
 
  December 31, 
  2023  2022 
Assets      
Current assets:      
Cash and cash equivalents $10,810  $9,244 
Short-term investments  91,379   159,644 
Prepaid expenses and other current assets  3,519   3,858 
Total current assets  105,708   172,746 
Property and equipment, net  4,957   6,453 
Operating lease right-of-use assets  19,120   22,072 
Restricted cash  1,765   1,565 
Long-term investments  26,413   23,943 
Other assets  1,821   1,028 
Total assets $159,784  $227,807 
       
Liabilities and stockholders' equity      
Current liabilities:      
Accounts payable $2,987  $3,594 
Accrued expenses and other current liabilities  12,486   15,140 
Deferred revenue  2,201   1,993 
Operating lease liabilities  2,782   2,391 
Total current liabilities  20,456   23,118 
Operating lease liabilities, net of current portion  17,437   20,220 
Deferred revenue, non-current  9,107   12,921 
Other long-term liabilities  43   42 
Total liabilities  47,043   56,301 
Commitments and contingencies      
Stockholders' equity:      
Preferred stock      
Common stock  1    
Additional paid-in capital  476,988   467,513 
Accumulated other comprehensive gain (loss)  37   (919)
Accumulated deficit  (364,285)  (295,088)
Total stockholders' equity  112,741   171,506 
Total liabilities, convertible preferred stock, and stockholders' equity $159,784  $227,807 



BOLT BIOTHERAPEUTICS, INC.
STATEMENTS OF CASH FLOWS
(In thousands)
 
  Years Ended December 31, 
  2023  2022 
CASH FLOWS FROM OPERATING ACTIVITIES:      
Net loss $(69,197) $(88,098)
Adjustments to reconcile net loss to net cash used      
in operating activities:      
Depreciation and amortization  1,854   1,666 
Stock-based compensation expense  9,223   9,576 
Accretion of premium/discount on short-term investments  (4,493)  184 
Non-cash lease expense  2,952   3,225 
Changes in operating assets and liabilities:      
Prepaid expenses and other assets  (454)  (903)
Accounts payable and accrued expenses  (3,413)  2,768 
Operating lease liabilities  (2,392)  (2,596)
Deferred revenue  (3,606)  (2,162)
Other long-term liabilities  1   (164)
Net cash used in operating activities  (69,525)  (76,504)
CASH FLOWS FROM INVESTING ACTIVITIES:      
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FAQ

What is the current cash balance of Bolt Biotherapeutics as of December 31, 2023?

Bolt Biotherapeutics had a cash balance of $128.6 million as of December 31, 2023.

What are the key highlights of BDC-1001 (trastuzumab imbotolimod) Phase 2 program?

BDC-1001 Phase 2 program is advancing in five distinct cohorts treating patients with HER2-positive cancer, showing a 29% objective response rate at the recommended Phase 2 dose.

What is the focus of the BDC-3042 Phase 1 study?

BDC-3042 is a proprietary agonist antibody targeting Dectin-2, evaluated in a dose-escalation Phase 1 clinical study for solid tumors.

How did Bolt Biotherapeutics perform financially in the fourth quarter and full year of 2023?

Bolt Biotherapeutics reported collaboration revenue of $2.1 million for the quarter and $7.9 million for the full year ended December 31, 2023. Research and Development expenses decreased to $16.3 million for the quarter and $61.5 million for the full year.

What was the loss from operations for Bolt Biotherapeutics in the full year ended December 31, 2023?

The loss from operations for Bolt Biotherapeutics was $76.2 million for the full year ended December 31, 2023.

Bolt Biotherapeutics, Inc.

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