HilleVax Reports Second Quarter 2024 Financial Results and Highlights Recent Company Progress

Rhea-AI Summary

HilleVax (Nasdaq: HLVX) reported its Q2 2024 financial results and recent company progress. Key points include:

- Cash position of $245.0 million as of June 30, 2024
- NEST-IN1 clinical study for HIL-214 in infants failed to meet efficacy endpoints
- Announced 40% workforce reduction to cut operating expenses
- Exploring potential development of HIL-214 and HIL-216 norovirus vaccines in adults
- Q2 2024 R&D expenses: $26.6 million, up from $23.0 million in Q2 2023
- Q2 2024 G&A expenses: $8.1 million, up from $7.2 million in Q2 2023
- Q2 2024 net loss: $40.7 million, increased from $27.9 million in Q2 2023

Positive

• Strong cash position of $245.0 million as of June 30, 2024
• Exploring potential development of HIL-214 and HIL-216 norovirus vaccines in adults
• 40% workforce reduction to decrease operating expenses

Negative

• NEST-IN1 clinical study for HIL-214 in infants failed to meet efficacy endpoints
• Discontinuation of HIL-214 development in infants
• Increased net loss to $40.7 million in Q2 2024 from $27.9 million in Q2 2023
• Higher R&D expenses of $26.6 million in Q2 2024 compared to $23.0 million in Q2 2023
• Increased G&A expenses of $8.1 million in Q2 2024 from $7.2 million in Q2 2023

Financial Analyst

HilleVax's Q2 2024 results reveal a concerning financial trajectory. The company's cash position decreased from $303.5 million to $245.0 million in six months, a 19.3% burn rate. This rapid cash depletion, coupled with increased R&D ($26.6 million, up 15.7% YoY) and G&A expenses ($8.1 million, up 12.5% YoY), signals unsustainable spending.

The failure of NEST-IN1 study and subsequent discontinuation of HIL-214 in infants is a major setback. The 40% workforce reduction, while necessary to curb expenses, may hinder future development capabilities. With a widening net loss ($40.7 million vs $27.9 million YoY), HilleVax faces significant challenges in pivoting its strategy and maintaining investor confidence.

Biotech Research Analyst

The failure of HIL-214 in the NEST-IN1 study is a critical blow to HilleVax's pipeline. Norovirus vaccines represent an unmet medical need and this setback could have industry-wide implications. The company's pivot to explore adult applications for HIL-214 and HIL-216 is a strategic move, but faces significant hurdles:

• Uncertain efficacy in a different population
• Potential need for new clinical trials
• Increased competition in the adult vaccine market

The 40% workforce reduction may compromise R&D capabilities, potentially slowing future progress. HilleVax's ability to salvage value from its norovirus program will be important for its survival and relevance in the competitive vaccine landscape.

Market Strategist

HilleVax's current situation presents a high-risk, high-reward scenario for investors. The company's focus on business development activities for its norovirus candidates suggests a potential pivot towards partnerships or licensing deals, which could provide much-needed capital and expertise.

However, the market's reaction to the NEST-IN1 failure and subsequent restructuring will likely be severely negative. Investors should watch for:

• Any announcements of strategic partnerships
• Progress in adult norovirus vaccine development
• Cash burn rate in upcoming quarters

With $245 million in cash, HilleVax has a runway to demonstrate value from its remaining assets. The company's ability to efficiently repurpose its technology and secure new funding will be critical for long-term viability.

$245.0 million of cash, cash equivalents and marketable securities as of June 30, 2024

The company is exploring the potential for continued development of its HIL-214 and HIL-216 norovirus vaccine candidates in adults

BOSTON, Aug. 08, 2024 (GLOBE NEWSWIRE) -- HilleVax, Inc. (Nasdaq: HLVX), a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines, today reported financial results for the quarter ended June 30, 2024 and highlighted recent progress.

Recent Business Highlights

• In Q3 2024, HilleVax announced that the NEST-IN1 clinical study did not meet its primary or secondary efficacy endpoints and that the company would discontinue further development of HIL-214 in infants.
• In Q3 2024, HilleVax announced a workforce reduction of approximately 40% of its workforce to reduce operating expenses while maintaining core capabilities as the company explores the potential for continued development of its HIL-214 and HIL-216 norovirus candidates as well as business development-related activities for these vaccine candidates.

Second Quarter 2024 Financial Results

As of June 30, 2024 and December 31, 2023, the company had cash, cash equivalents and marketable securities totaling $245.0 million and $303.5 million, respectively.

Research and development expenses for the second quarter 2024 were $26.6 million, compared to $23.0 for the second quarter 2023. The increase was primarily due to the growth in the number of R&D employees.

General and administrative expenses for the second quarter 2024 were $8.1 million, compared to $7.2 million for the second quarter 2023. The increase was primarily due to the growth in the number of G&A employees.

Other income for the second quarter 2024 and second quarter 2023 was $2.3 million.

Net loss for the second quarter 2024 was $40.7 million, compared to $27.9 million for the second quarter 2023.

About HilleVax

HilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Its initial programs, HIL-214 and HIL-216, are virus-like particle (VLP) based vaccine candidates in development for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection. Globally, norovirus is estimated to result in over approximately 700 million cases of AGE and 200,000 deaths per year, resulting in over $4 billion in direct health system costs and $60 billion in societal costs per year. The burden of norovirus falls disproportionately on young children and older adults. For more information about HilleVax, visit the company’s website at http://www.HilleVax.com.

Forward-Looking Statements

The company 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 the company’s current beliefs and expectations and include, but are not limited to, the company’s plans to explore continued development efforts on, and advance the development of, HIL-214 and HIL-216 in adults and the potential opportunity for and benefits of HIL-214 and HIL-216, and intended objectives and benefits of the workforce reduction. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in the company’s business, including, without limitation: to-date the company has depended primarily on the success of HIL-214, and the company may be unable to identify a viable development path forward for HIL-214 or HIL-216; if the company does identify a development path forward for its vaccine candidates, the company may require additional capital and other resources, including business development partnerships or other strategic collaborations, and the company may be unable to secure partnerships, other strategic collaborations or other resources on acceptable terms or at all; topline results are based on preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the NEST-IN1 study and such topline data may not accurately reflect the complete results of a clinical trial; to the extent the company pursues future studies, the company may experience potential delays in the commencement, enrollment, data readouts and completion of clinical trials and preclinical studies; the company depends on third parties in connection with manufacturing, research and clinical and preclinical testing; unexpected adverse side effects or inadequate immunogenicity or efficacy of HIL-214, HIL-216 or any future vaccine candidates that may limit their development, regulatory approval, commercialization and/or business development potential; further unfavorable results from clinical trials; results from prior clinical trials and studies are not necessarily predictive of future results; the company relies on intellectual property rights under its license agreements with Takeda Vaccines, Inc. and Kanghua Biological Products Co., Ltd.; the company may be unable to obtain, maintain and enforce intellectual property protection for its vaccine candidates; the company may use its capital resources sooner than it expects; and other risks described in the company’s prior press releases and the company’s filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in the company’s annual report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and the company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Contact:

Shane Maltbie
IR@hillevax.com
+1-617-213-5054

HilleVax, Inc.
Condensed Consolidated Statement of Operations Data
(in thousands, except share and per share data)
(unaudited)
		Three Months Ended								Six Months Ended
		June 30,								June 30,
		2024				2023				2024				2023
Operating expenses:
Research and development		$	26,601			$	22,953			$	52,579			$	46,117
In-process research and development			—				—				15,325				—
General and administrative			8,127				7,231				16,621				13,026
Impairment charges			8,235				—				8,235				—
Total operating expenses			42,963				30,184				92,760				59,143
Loss from operations			(42,963	)			(30,184	)			(92,760	)			(59,143	)
Total other income			2,295				2,282				5,263				4,352
Net loss		$	(40,668	)		$	(27,902	)		$	(87,497	)		$	(54,791	)
Net loss per share, basic and diluted		$	(0.83	)		$	(0.74	)		$	(1.79	)		$	(1.45	)
Weighted-average shares of common stock outstanding, basic and diluted			49,179,109				37,951,735				48,819,729				37,853,176

HilleVax, Inc.
Condensed Consolidated Balance Sheet Data
(in thousands)
(unaudited)
		June 30, 2024				December 31, 2023
Cash, cash equivalents and marketable securities		$	245,040			$	303,483
Total assets			276,931				344,434
Total liabilities			72,001				78,909
Total stockholders’ equity			204,930				265,525
Total liabilities and stockholders’ equity			276,931				344,434

FAQ

What were HilleVax's (HLVX) Q2 2024 financial results?

HilleVax reported a net loss of $40.7 million for Q2 2024, with R&D expenses of $26.6 million and G&A expenses of $8.1 million. The company had $245.0 million in cash, cash equivalents, and marketable securities as of June 30, 2024.

Why did HilleVax (HLVX) announce a workforce reduction in Q3 2024?

HilleVax announced a 40% workforce reduction to decrease operating expenses while maintaining core capabilities as the company explores potential development of its norovirus vaccine candidates and pursues business development activities.

What happened with HilleVax's (HLVX) NEST-IN1 clinical study for HIL-214?

The NEST-IN1 clinical study for HIL-214 in infants did not meet its primary or secondary efficacy endpoints. As a result, HilleVax decided to discontinue further development of HIL-214 in infants.

What are HilleVax's (HLVX) plans for its norovirus vaccine candidates after the NEST-IN1 study results?

HilleVax is exploring the potential for continued development of its HIL-214 and HIL-216 norovirus vaccine candidates in adults, as well as pursuing business development-related activities for these vaccine candidates.