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

Rhea-AI Summary

Bolt Biotherapeutics (Nasdaq: BOLT) reported Q2 2024 financial results and provided a business update. Key highlights include:

1. Advancement to cohort 6 in the Phase 1 study of BDC-3042 for advanced cancers.

2. Acceptance of an abstract for BDC-4182, a claudin 18.2-targeting Boltbody ISAC, at the SITC 39th Annual Meeting.

3. Cash balance of $97.5 million as of June 30, 2024, expected to fund operations through mid-2026.

4. Q2 2024 financial results: Collaboration revenue of $1.3 million, R&D expenses of $15.4 million, G&A expenses of $4.9 million, and a loss from operations of $22.6 million.

5. Ongoing collaborations with Genmab and Toray continue to progress.

Positive

• Advanced to cohort 6 in Phase 1 study of BDC-3042 with no dose-limiting toxicities
• Abstract accepted for BDC-4182 at SITC 39th Annual Meeting
• Strong cash position of $97.5 million expected to fund operations through mid-2026
• Collaborations with Genmab and Toray progressing well

Negative

• Loss from operations increased to $22.6 million in Q2 2024 from $19.8 million in Q2 2023
• Restructuring charges of $3.6 million incurred in Q2 2024
• Slight decrease in collaboration revenue from $1.4 million in Q2 2023 to $1.3 million in Q2 2024

Insights

Financial Analyst

Bolt Biotherapeutics' Q2 2024 results reveal a mixed financial picture. The company's $97.5 million cash position is a positive aspect, providing runway through mid-2026. However, the widening operating loss of $22.6 million compared to $19.8 million in Q2 2023 is concerning. The $3.6 million restructuring charge impacts short-term financials but may lead to long-term cost savings. Collaboration revenue remained relatively stable at $1.3 million, while R&D expenses were controlled at $15.4 million. The 12.5% reduction in G&A expenses to $4.9 million shows effective cost management. Investors should monitor cash burn rate and potential milestone payments from collaborations as key financial indicators moving forward.

Medical Research Analyst

The advancement to Cohort 6 in the Phase 1 study of BDC-3042 is promising, indicating favorable safety profile thus far. This Dectin-2 agonist antibody targets tumor-associated macrophages, a novel approach in cancer immunotherapy. The diverse cancer types included in the trial (TNBC, colorectal, renal cell, head and neck, NSCLC, ovarian, melanoma) suggest broad potential applications. The upcoming presentation on BDC-4182, targeting claudin 18.2, at SITC is noteworthy, as this target has shown promise in gastric and pancreatic cancers. The progression of two distinct programs (BDC-3042 and BDC-4182) demonstrates a balanced pipeline strategy. However, investors should note that both programs are still in early stages, with significant clinical hurdles ahead.

• Advanced to Cohort 6 in the Phase 1 dose-escalation clinical study of BDC-3042 in patients with advanced cancers
  
• Abstract accepted for BDC-4182, a claudin 18.2-targeting Boltbody^TM ISAC at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting
• Cash balance of $97.5 million as of June 30, 2024 anticipated to fund key milestones through mid-2026

REDWOOD CITY, Calif., Aug. 13, 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 second quarter ended June 30, 2024, and provided a business update.

“During the second quarter, we continued to make significant progress across our two programs, BDC-3042 and BDC-4182, following our strategic pipeline prioritization in May,” said Willie Quinn, Chief Executive Officer. “For our lead program BDC-3042, we completed the safety evaluation period for cohort 5 with no dose-limiting toxicities. BDC-3042 continues to be well tolerated to date, and we are now enrolling patients into cohort 6. We will be presenting a poster on BDC-4182, our claudin 18.2-targeting Boltbody^TM ISAC, at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting, and we look forward to sharing more data on this program in November. I’m proud that the team has not missed a beat working through our strategic pipeline prioritization and restructuring. Our strong cash position allows us to move these programs through early clinical development and provides us with cash runway through mid-2026.”

Recent Highlights and Anticipated Milestones

• Advanced to cohort 6 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. 
• Preparing BDC-4182 to start clinical trials in 2025. BDC-4182 is a next-generation Boltbody^TM 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. A poster on BDC-4182 will be presented at the Society for Immunotherapy of Cancer (SITC) 39^th Annual Meeting, which will take place from November 6-10, 2024, in Houston, Texas.
  
• 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. Recent developments with Genmab supported the extension of the original initial research phase of the collaboration.
  
• Cash, cash equivalents, and marketable securities were $97.5 million as of June 30, 2024. Cash on hand is expected to fund multiple milestones and operations through mid-2026.

Second Quarter 2024 Financial Results

• Collaboration Revenue – Collaboration revenue was $1.3 million for the quarter ended June 30, 2024, compared to $1.4 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 $15.4 million for the quarter ended June 30, 2024, compared to $15.6 million for the same quarter in 2023.
• General and Administrative (G&A) Expenses – G&A expenses were $4.9 million for the quarter ended June 30, 2024, compared to $5.6 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 due to a decrease in bonus expense as a result of the restructuring plan.
• Restructuring Charges – Restructuring charges were $3.6 million for the quarter ended June 30, 2024, consisting of $2.9 million of one-time termination benefits such as severance costs and related benefits and $0.7 million of non-cash stock-based compensation expense as a result of the restructuring plan. There were no restructuring charges in the quarter ended June 30, 2023.
• Loss from Operations – Loss from operations was $22.6 million for the quarter ended June 30, 2024, compared to $19.8 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 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2024. 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 June 30,								Six Months Ended June 30,
	2024				2023				2024				2023
Collaboration revenue	$	1,275			$	1,433			$	6,549			$	3,259
Operating expenses:
Research and development		15,433				15,644				31,962				30,269
General and administrative		4,874				5,621				10,711				11,237
Restructuring charges		3,565				—				3,565				—
Total operating expense		23,872				21,265				46,238				41,506
Loss from operations		(22,597	)			(19,832	)			(39,689	)			(38,247	)
Other income, net
Interest income, net		1,402				1,775				3,008				3,210
Other income		—				—				4,675				—
Total other income, net		1,402				1,775				7,683				3,210
Net loss		(21,195	)			(18,057	)			(32,006	)			(35,037	)
Net unrealized (loss) gain on marketable securities		(8	)			6				(81	)			690
Comprehensive loss	$	(21,203	)		$	(18,051	)		$	(32,087	)		$	(34,347	)
Net loss per share, basic and diluted	$	(0.56	)		$	(0.48	)		$	(0.84	)		$	(0.93	)
Weighted-average shares outstanding, basic and diluted		38,128,344				37,750,393				38,098,383				37,717,391

BOLT BIOTHERAPEUTICS, INC.
CONDENSED BALANCE SHEETS
(Unaudited, in thousands)
	June 30,				December 31,
	2024				2023
Assets
Current assets:
Cash and cash equivalents	$	6,202			$	10,810
Short-term investments		67,495				91,379
Prepaid expenses and other current assets		2,934				3,519
Total current assets		76,631				105,708
Property and equipment, net		4,079				4,957
Operating lease right-of-use assets		17,559				19,120
Restricted cash		1,765				1,765
Long-term investments		23,834				26,413
Other assets		308				1,821
Total assets	$	124,176			$	159,784
Liabilities and stockholders' equity
Current liabilities:
Accounts payable	$	2,627			$	2,987
Accrued expenses and other current liabilities		10,254				12,486
Deferred revenue		2,024				2,201
Operating lease liabilities		2,995				2,782
Total current liabilities		17,900				20,456
Operating lease liabilities, net of current portion		15,896				17,437
Deferred revenue, non-current		4,520				9,107
Other long-term liabilities		-				43
Total liabilities		38,316				47,043
Commitments and contingencies
Stockholders' equity:
Preferred stock		—				—
Common stock		1				1
Additional paid-in capital		482,194				476,988
Accumulated other comprehensive (loss) gain		(44	)			37
Accumulated deficit		(396,291	)			(364,285	)
Total stockholders' equity:		85,860				112,741
Total liabilities and stockholders' equity	$	124,176			$	159,784

BOLT BIOTHERAPEUTICS, INC.
CONDENSED STATEMENTS OF CASH FLOWS
(Unaudited, in thousands)
	Six Months Ended June 30,
	2024				2023
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$	(32,006	)		$	(35,037	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization		915				925
Stock-based compensation expense		5,127				4,826
Accretion of discount on marketable securities		(1,824	)			(1,964	)
Non-cash lease expense		1,561				1,450
Changes in operating assets and liabilities:
Prepaid expenses and other assets		2,098				(928	)
Accounts payable and accrued expenses		(2,629	)			(5,428	)
Operating lease liabilities		(1,328	)			(1,139	)
Deferred revenue		(4,764	)			(1,217	)
Other long-term liabilities		(43	)			1
Net cash used in operating activities		(32,893	)			(38,511	)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property and equipment		—				(35	)
Purchases of marketable securities		(55,283	)			(96,524	)
Maturities of marketable securities		83,489				139,130
Net cash provided by investing activities		28,206				42,571
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		(4,608	)			4,207
Cash, cash equivalents and restricted cash at beginning of year		12,575				10,809
Cash, cash equivalents and restricted cash at end of period	$	7,967			$	15,016
Reconciliation of cash, cash equivalents and restricted cash:
Cash and cash equivalents	$	6,202			$	13,451
Restricted cash		1,765				1,565
Total cash, cash equivalents and restricted cash	$	7,967			$	15,016
Supplemental schedule of non-cash investing and financing activities:
Purchases of property and equipment included in accounts payable and accrued liabilities	$	37			$	46
Deferred offering costs in accounts payable and accrued liabilities	$	102			$	102

FAQ

What is the current status of Bolt Biotherapeutics' BDC-3042 clinical trial?

Bolt Biotherapeutics has advanced to cohort 6 in the Phase 1 dose-escalation clinical study of BDC-3042 in patients with advanced cancers. The drug continues to be well-tolerated with no dose-limiting toxicities reported in cohort 5.

What is Bolt Biotherapeutics' cash position as of Q2 2024?

Bolt Biotherapeutics reported a cash balance of $97.5 million as of June 30, 2024. This is expected to fund key milestones and operations through mid-2026.

When is Bolt Biotherapeutics (BOLT) planning to start clinical trials for BDC-4182?

Bolt Biotherapeutics is preparing BDC-4182, their claudin 18.2-targeting Boltbody ISAC, to start clinical trials in 2025.

What were Bolt Biotherapeutics' (BOLT) key financial results for Q2 2024?

For Q2 2024, Bolt Biotherapeutics reported collaboration revenue of $1.3 million, R&D expenses of $15.4 million, G&A expenses of $4.9 million, and a loss from operations of $22.6 million.