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Bolt Biotherapeutics Reports Third Quarter 2024 Financial Results and Provides Business Update

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Bolt Biotherapeutics (BOLT) reported Q3 2024 financial results, highlighting progress in its cancer immunotherapy programs. The company advanced to the highest dose level in BDC-3042's Phase 1 trial and presented updated preclinical data for BDC-4182 at SITC. Q3 revenue was $1.1 million, down from $2.5 million in Q3 2023. R&D expenses decreased to $13.8 million from $15.0 million, while G&A expenses reduced to $3.8 million from $5.8 million. The company reported an operational loss of $16.4 million. With $84.4 million in cash, funding is expected to last through mid-2026.

Bolt Biotherapeutics (BOLT) ha riportato i risultati finanziari del terzo trimestre del 2024, evidenziando i progressi nei suoi programmi di immunoterapia contro il cancro. L'azienda è passata al livello di dose più alto nella fase 1 dello studio clinico BDC-3042 e ha presentato dati preclinici aggiornati per BDC-4182 al SITC. I ricavi del terzo trimestre sono stati di $1,1 milioni, in calo rispetto ai $2,5 milioni del terzo trimestre del 2023. Le spese per Ricerca e Sviluppo sono diminuite a $13,8 milioni rispetto ai $15 milioni, mentre le spese generali e amministrative sono scese a $3,8 milioni rispetto ai $5,8 milioni. L'azienda ha registrato una perdita operativa di $16,4 milioni. Con $84,4 milioni in contante, si prevede che i finanziamenti dureranno fino a metà 2026.

Bolt Biotherapeutics (BOLT) informó los resultados financieros del tercer trimestre de 2024, destacando los avances en sus programas de inmunoterapia contra el cáncer. La compañía avanzó al nivel de dosis más alto en el ensayo clínico de fase 1 del BDC-3042 y presentó datos preclínicos actualizados para el BDC-4182 en el SITC. Los ingresos del tercer trimestre fueron de $1.1 millones, en comparación con $2.5 millones en el tercer trimestre de 2023. Los gastos de I+D disminuyeron a $13.8 millones desde $15.0 millones, mientras que los gastos generales y administrativos se redujeron a $3.8 millones desde $5.8 millones. La compañía reportó una pérdida operativa de $16.4 millones. Con $84.4 millones en efectivo, se espera que la financiación dure hasta mediados de 2026.

볼트 생물 의학(Bolt Biotherapeutics, BOLT)는 2024년 3분기 재무 결과를 발표하며 암 면역치료 프로그램의 진전을 강조했습니다. 회사는 BDC-3042의 1상 시험에서 최고 용량 단계로 진입했으며, SITC에서 BDC-4182에 대한 업데이트된 전임상 데이터를 발표했습니다. 3분기 수익은 $1.1백만으로, 2023년 3분기의 $2.5백만에서 감소했습니다. R&D 비용은 $13.8백만으로 감소했으며, 이는 $15.0백만에서 줄어든 수치입니다. 일반 관리비는 $3.8백만으로 줄어들어 $5.8백만에서 감소했습니다. 회사는 $16.4백만의 운영 손실을 보고했습니다. $84.4백만의 현금을 보유하고 있어, 자금은 2026년 중반까지 지속될 것으로 예상됩니다.

Bolt Biotherapeutics (BOLT) a annoncé les résultats financiers du troisième trimestre 2024, mettant en avant les progrès réalisés dans ses programmes d'immunothérapie contre le cancer. La société est passée au niveau de dose le plus élevé dans l'essai de phase 1 du BDC-3042 et a présenté des données précliniques mises à jour pour le BDC-4182 lors du SITC. Les revenus du troisième trimestre se sont élevés à $1,1 million, contre $2,5 millions au troisième trimestre 2023. Les dépenses de R&D ont diminué à $13,8 millions contre $15,0 millions, tandis que les dépenses générales et administratives ont été réduites à $3,8 millions contre $5,8 millions. La société a enregistré une perte opérationnelle de $16,4 millions. Avec $84,4 millions de liquidités, il est prévu que le financement dure jusqu'à mi-2026.

Bolt Biotherapeutics (BOLT) hat die finanziellen Ergebnisse für das dritte Quartal 2024 veröffentlicht und dabei Fortschritte in seinen Krebsimmuntherapie-Programmen hervorgehoben. Das Unternehmen hat die höchste Dosisstufe in der Phase-1-Studie zu BDC-3042 erreicht und aktualisierte präklinische Daten zu BDC-4182 auf dem SITC vorgestellt. Die Einnahmen im dritten Quartal beliefen sich auf 1,1 Millionen US-Dollar, was einen Rückgang von 2,5 Millionen US-Dollar im dritten Quartal 2023 darstellt. Die F&E-Ausgaben sanken auf 13,8 Millionen US-Dollar von 15,0 Millionen US-Dollar, während die allgemeinen und administrativen Ausgaben auf 3,8 Millionen US-Dollar von 5,8 Millionen US-Dollar gesenkt wurden. Das Unternehmen berichtete von einem betrieblichen Verlust von 16,4 Millionen US-Dollar. Mit 84,4 Millionen US-Dollar in bar wird erwartet, dass die Finanzierung bis Mitte 2026 ausreicht.

Positive
  • Cash position of $84.4 million sufficient to fund operations through mid-2026
  • Reduced R&D expenses by $1.2 million year-over-year
  • Decreased G&A expenses by $2 million year-over-year
  • Reduced operational loss by $1.8 million compared to Q3 2023
Negative
  • Collaboration revenue declined 56% to $1.1 million from $2.5 million year-over-year
  • Operational loss of $16.4 million in Q3 2024

Insights

The Q3 results reveal a mixed financial picture for Bolt Biotherapeutics. The company's $84.4 million cash position provides a decent runway through mid-2026, but operational metrics show concerning trends. Revenue declined 56% year-over-year to $1.1 million, while operating losses remain substantial at $16.4 million. The May 2024 restructuring has helped reduce expenses, with R&D costs down 8% to $13.8 million and G&A expenses dropping 34.5% to $3.8 million. Despite pipeline progress with BDC-3042 and BDC-4182, the company's high cash burn rate and declining collaboration revenue raise sustainability concerns, though the current cash runway provides some breathing room for key clinical milestones.

The clinical pipeline shows promising developments. BDC-3042's advancement to the highest dose level (10 mg/kg) in Phase 1 trials marks significant progress in targeting tumor-associated macrophages. The preclinical data for BDC-4182, targeting claudin 18.2, demonstrates enhanced potency compared to conventional ADCs, with good tolerability up to 12mg/kg in non-human primates. The learnings from BDC-1001's Phase 1 trial, showing stronger immune activation in high HER2-expressing tumors, have informed the development of next-generation ISACs. This strategic pivot towards more potent compounds could improve efficacy in treating tumors with lower target expression levels.

  • Advanced to the highest dose level in the Phase 1 dose-escalation clinical study of BDC-3042 in patients with advanced cancers
  • Presented updated preclinical activity of BDC-4182 and key learnings from Phase 1 dose-escalation trial of BDC-1001 at the SITC 39th Annual Meeting
  • BDC-4182 on track to start clinical trial in second quarter 2025
  • Cash balance of $84.4 million as of September 30, 2024 anticipated to fund key milestones through mid-2026

REDWOOD CITY, Calif., Nov. 12, 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 third quarter ended September 30, 2024, and provided a business update.

“During the third quarter, we continued to make progress with our two proprietary programs, BDC-3042 and BDC-4182,” said Willie Quinn, Chief Executive Officer. “We have now completed the sixth dose level in the first-in-human clinical trial of BDC-3042, have opened the final cohort which will study a dose level of 10 mg/kg, and expect to provide a data update in the first half of 2025. We are particularly excited about our next-generation ISAC BDC-4182, which builds on the lessons we learned from our clinical experience with BDC-1001. We believe that BDC-4182’s dramatic increase in potency and activity will potentially enable the treatment of patients whose tumors have lower claudin 18.2 expression and may provide even better anti-tumor activity than conventional ADCs. We presented some of the data that underlies this excitement at SITC, and the team is hard at work preparing for a clinical trial initiation of BDC-4182 in the second quarter next year.”

Recent Highlights and Anticipated Milestones

  • Presented updated clinical activity of BDC-4182 at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC). BDC-4182 is a next-generation BoltbodyTM ISAC clinical candidate targeting claudin 18.2, a novel, clinically validated target in oncology with expression in gastric/gastroesophageal junction cancer, pancreatic cancer, and other tumor types. BDC-4182 has advanced into IND-enabling activities, supported by in vitro and in vivo experiments demonstrating potent anti-tumor activity in multiple preclinical models, with clinical trial initiation expected in 2025. BDC-4182 was well tolerated in non-human primates at the highest dose tested (12mg/kg) with an acceptable safety profile. BDC-4182 outperformed cytotoxic claudin 18.2 ADCs in syngeneic models and BDC-4182’s favorable toxicology profile enables a variety of potential future combinations.
  • Presented key learnings from Phase 1 dose-escalation trial of BDC-1001 at SITC. First-generation ISAC BDC-1001 demonstrated immunological activity in this first-in-human trial, particularly in patients with high HER2 antigen expression. Greater immune activation appeared to be associated with clinical benefit. Pharmacodynamic changes were observed in patients whose tumors had higher levels of HER2 and were statistically significant in patients with HER2 IHC 3+ tumors. Data supports the hypothesis that an ISAC with enhanced immune activation could offer greater efficacy, warranting further testing in next-generation ISACs.
  • Advanced to cohort 7 (10 mg/kg) in the Phase 1 study of BDC-3042 in patients with advanced cancers. BDC-3042 is a proprietary agonist antibody that targets Dectin-2, an immune-activating receptor expressed by tumor-associated macrophages (TAMs). This single-agent, dose-escalation Phase 1 clinical study is evaluating BDC-3042 in patients with metastatic or unresectable triple-negative breast cancer (TNBC), colorectal cancer, clear cell renal cell carcinoma, head and neck cancer, non-small cell lung cancer (NSCLC), ovarian cancer, or melanoma.
  • Collaborations with Genmab and Toray continue to progress. The Company continues to work with its collaborators to discover and develop ISACs for the treatment of cancer. Genmab and the Company have selected a product to advance into development for the collaboration’s first program. The Genmab collaboration also continues research and development on additional programs.
  • Cash, cash equivalents, and marketable securities were $84.4 million as of September 30, 2024. Cash on hand is expected to fund multiple milestones and operations through mid-2026.

Third Quarter 2024 Financial Results

  • Collaboration Revenue – Collaboration revenue was $1.1 million for the quarter ended September 30, 2024, compared to $2.5 million for the same quarter in 2023. Revenue in the comparative periods was generated from services performed under the R&D collaborations as we fulfill our performance obligations.
  • Research and Development (R&D) Expenses – R&D expenses were $13.8 million for the quarter ended September 30, 2024, compared to $15.0 million for the same quarter in 2023. The decrease between the comparable periods was mainly due to a decrease in salary and related expenses primarily as a result of the May 2024 restructuring, partially offset by an increase in contract manufacturing expenses.
  • General and Administrative (G&A) Expenses – G&A expenses were $3.8 million for the quarter ended September 30, 2024, compared to $5.8 million for the same quarter in 2023. The decrease between the comparable periods was mainly due to a decrease in salary and related expenses primarily as a result of the May 2024 restructuring.
  • Loss from Operations – Loss from operations was $16.4 million for the quarter ended September 30, 2024, compared to $18.2 million for the same quarter in 2023.

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 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 BDC-3042, a first-in-class agonist antibody that activates macrophages by targeting Dectin-2, and BDC-4182, a next-generation Boltbody™ Immune-Stimulating Antibody Conjugate (ISAC) clinical candidate targeting claudin 18.2. BDC-3042 is currently in a Phase 1 dose escalation trial that includes patients with any of seven different solid tumor types. BDC-4182 is supported by strong in vitro and in vivo data demonstrating potent anti-tumor activity, and activities are underway to support the initiation of clinical trials in 2025. Bolt Biotherapeutics is also developing additional 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 BDC-3042 clinical trial, the potential initiation of clinical trials for BDC-4182, the anti-tumor potency, safety and tolerability, and characteristics of our product candidates, the initiation of future clinical trials, the potential value of collaborations, and the expected duration of our cash runway, 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.
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited, in thousands, except share and per share amounts)
 
  Three Months Ended
September 30,
  Nine Months Ended
September 30,
 
  2024
 2023  2024
 2023 
Collaboration revenue $1,141  $2,528  $7,690  $5,787 
Operating expenses:            
Research and development  13,785   14,951   45,747   45,220 
General and administrative  3,799   5,760   14,510   16,997 
Restructuring charges        3,565    
Total operating expense  17,584   20,711   63,822   62,217 
Loss from operations  (16,443)  (18,183)  (56,132)  (56,430)
Other income, net            
Interest income, net  1,267   1,926   4,275   5,136 
Other income        4,675    
Total other income, net  1,267   1,926   8,950   5,136 
Net loss  (15,176)  (16,257)  (47,182)  (51,294)
Net unrealized gain on marketable securities  249   55   168   745 
Comprehensive loss $(14,927) $(16,202) $(47,014) $(50,549)
Net loss per share, basic and diluted $(0.40) $(0.43) $(1.24) $(1.36)
Weighted-average shares outstanding, basic and diluted  38,250,982   37,868,480   38,149,830   37,768,308 
                 


 
BOLT BIOTHERAPEUTICS, INC.
CONDENSED BALANCE SHEETS
(Unaudited, in thousands)
  September 30,
 2024
 December 31,
2023
Assets     
Current assets:      
Cash and cash equivalents $9,366  $10,810 
Short-term investments  44,432   91,379 
Restricted cash  792    
Prepaid expenses and other current assets  2,557   3,519 
Total current assets  57,147   105,708 
Property and equipment, net  3,565   4,957 
Operating lease right-of-use assets  16,756   19,120 
Restricted cash, non-current  981   1,765 
Long-term investments  30,598   26,413 
Other assets  287   1,821 
Total assets $109,334  $159,784 
Liabilities and stockholders' equity      
Current liabilities:      
Accounts payable $1,482  $2,987 
Accrued expenses and other current liabilities  11,806   12,486 
Deferred revenue  1,971   2,201 
Operating lease liabilities  2,824   2,782 
Total current liabilities  18,083   20,456 
Operating lease liabilities, net of current portion  15,353   17,437 
Deferred revenue, non-current  3,867   9,107 
Other long-term liabilities  -   43 
Total liabilities  37,303   47,043 
Commitments and contingencies      
Stockholders' equity:      
Preferred stock      
Common stock  1   1 
Additional paid-in capital  483,292   476,988 
Accumulated other comprehensive gain  205   37 
Accumulated deficit  (411,467)  (364,285)
Total stockholders' equity:  72,031   112,741 
Total liabilities and stockholders' equity $109,334  $159,784 
       


 
BOLT BIOTHERAPEUTICS, INC.
CONDENSED STATEMENTS OF CASH FLOWS
(Unaudited, in thousands)
  Nine Months Ended September 30,
  2024  2023
CASH FLOWS FROM OPERATING ACTIVITIES:      
Net loss $(47,182) $(51,294)
Adjustments to reconcile net loss to net cash used in operating activities:      
Depreciation and amortization  1,355   1,387 
Stock-based compensation expense  6,225   7,155 
Accretion of discount on marketable securities  (2,307)  (3,299)
Gain on sale of fixed assets  (70)   
Non-cash lease expense  2,364   2,194 
Changes in operating assets and liabilities:      
Prepaid expenses and other assets  2,496   (2,198)
Accounts payable and accrued expenses  (2,185)  (4,601)
Operating lease liabilities  (2,042)  (1,754)
Deferred revenue  (5,470)  (2,851)
Other long-term liabilities  (43)  1 
Net cash used in operating activities  (46,859)  (55,260)
CASH FLOWS FROM INVESTING ACTIVITIES:      
Purchase of property and equipment  (41)  (200)
Proceeds from sales of property and equipment  148    
Purchases of marketable securities  (75,602)  (132,828)
Maturities of marketable securities  120,839   188,257 
Net cash provided by investing activities  45,344   55,229 
CASH FLOWS FROM FINANCING ACTIVITIES:      
Proceeds from issuance of common stock  79   147 
Net cash provided by financing activities  79   147 
Net (decrease) increase in cash  (1,436)  116 
Cash, cash equivalents and restricted cash at beginning of year  12,575   10,809 
Cash, cash equivalents and restricted cash at end of period $11,139  $10,925 
Reconciliation of cash, cash equivalents and restricted cash:      
Cash and cash equivalents $9,366  $9,160 
Restricted cash  1,773   1,765 
Total cash, cash equivalents and restricted cash $11,139  $10,925 
         

FAQ

What was Bolt Biotherapeutics (BOLT) revenue in Q3 2024?

Bolt Biotherapeutics reported collaboration revenue of $1.1 million for Q3 2024, compared to $2.5 million in Q3 2023.

How much cash does BOLT have as of Q3 2024?

BOLT reported $84.4 million in cash, cash equivalents, and marketable securities as of September 30, 2024.

When will BOLT start clinical trials for BDC-4182?

BOLT expects to initiate clinical trials for BDC-4182 in the second quarter of 2025.

What was BOLT's operating loss in Q3 2024?

BOLT reported an operating loss of $16.4 million for Q3 2024, compared to $18.2 million in Q3 2023.

Bolt Biotherapeutics, Inc.

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