Financial Performance - The company reported net losses of $40.7 million for the three months ended June 30, 2024, compared to $27.9 million for the same period in 2023, and an accumulated deficit of $476.1 million as of June 30, 2024[101]. - Net loss for Q2 2024 was $40.7 million, compared to a net loss of $27.9 million in Q2 2023, representing an increase of $12.8 million[117]. - The company anticipates continued net losses as it progresses with the development of HIL-214 and HIL-216[125]. Cash and Liquidity - As of June 30, 2024, the company had cash, cash equivalents, and marketable securities totaling $245.0 million, which is expected to meet cash requirements for at least the next 12 months[100]. - The company anticipates that existing cash, cash equivalents, and marketable securities will be sufficient to meet anticipated cash requirements for at least the next 12 months[136]. - Net cash used in operating activities for the six months ended June 30, 2024, was $62.8 million, primarily due to a net loss of $87.5 million[140]. - Net cash used in investing activities for the six months ended June 30, 2024, was $61.1 million, attributed to $139.6 million in purchases of marketable securities[142]. - Net cash provided by financing activities for the six months ended June 30, 2024, was $15.7 million, mainly from $14.9 million of net proceeds from the issuance of common stock[143]. Research and Development - The company plans to discontinue further development of HIL-214 in infants after a Phase 2b trial did not meet its primary efficacy endpoint[98]. - Research and development expenses primarily related to HIL-214 were incurred, including costs for clinical trials and manufacturing[110]. - Research and development expenses for Q2 2024 were $26.6 million, an increase of $3.6 million from $22.9 million in Q2 2023, primarily due to personnel-related expenses[117]. - In-process research and development expenses for the first half of 2024 were $15.3 million related to the Kangh License, with no such expenses in the first half of 2023[122]. Operating Expenses - Total operating expenses for Q2 2024 were $42.9 million, up from $30.2 million in Q2 2023, reflecting an increase of $12.8 million[117]. - Total operating expenses for the first half of 2024 reached $92.8 million, a significant increase from $59.1 million in the first half of 2023, reflecting a change of $33.6 million[121]. - Impairment charges for Q2 2024 amounted to $8.2 million, attributed to a decline in market capitalization following the release of clinical study data[118]. Financing Activities - The company raised aggregate gross proceeds of $137.2 million from convertible promissory notes and completed an IPO in May 2022, raising net proceeds of approximately $209.5 million[100]. - A public offering completed on September 22, 2023, resulted in the sale of 9,200,000 shares at a public offering price of $12.50 per share, generating total net proceeds of $107.8 million[135]. - The company entered into an At-the-Market Equity Offering Sales Agreement with an aggregate offering price of up to $100.0 million, selling 1,016,950 shares for total net proceeds of approximately $14.9 million as of June 30, 2024[134]. - The company has a term loan facility of up to $75.0 million, with various tranches and conditions for borrowing based on clinical development milestones[127]. - As of June 30, 2024, total outstanding borrowings under the Loan Agreement were $26.0 million, with future minimum principal, interest, and final payment fees due approximately $33.2 million[132]. - The company repaid all outstanding indebtedness on July 19, 2024, making a final payment of $28.5 million, which included a final payment fee and prepayment fee of $2.3 million[133]. Agreements and Collaborations - The company entered into a license agreement with Takeda for HIL-214, which includes potential milestone payments of up to $150.0 million and tiered royalties on net sales[105]. - An exclusive license agreement with Chengdu Kanghua Biological Products Co., Ltd. for HIL-216 includes an upfront payment of $15.0 million and potential milestone payments of up to $255.5 million[108]. - The company incurred $36,000 and $58,000 in research and development expenses for Takeda's services for the three and six months ended June 30, 2024, respectively[106]. Market and Risk Disclosures - The company has not generated any revenue and does not expect to do so until regulatory approval for HIL-214 or HIL-216 is achieved, which may take several years[102]. - Recent accounting pronouncements are detailed in Item 1 of Part I, specifically in Note 2 regarding significant accounting policies[150]. - Item 3 indicates that quantitative and qualitative disclosures about market risk are not applicable to a smaller reporting company[150].

Core Insights - HilleVax, Inc. reported financial results for Q2 2024, highlighting a net loss of $40.7 million, an increase from $27.9 million in Q2 2023, and cash reserves of $245.0 million as of June 30, 2024 [1][4][9] Recent Business Highlights - The NEST-IN1 clinical study for HIL-214 did not meet its efficacy endpoints, leading to the discontinuation of its development in infants [2] - The company announced a workforce reduction of approximately 40% to cut operating expenses while maintaining core capabilities for the development of HIL-214 and HIL-216 [2] Financial Performance - Research and development expenses for Q2 2024 were $26.6 million, up from $23.0 million in Q2 2023, attributed to an increase in R&D personnel [3] - General and administrative expenses rose to $8.1 million in Q2 2024 from $7.2 million in Q2 2023, also due to a rise in G&A staff [4] - Total operating expenses for Q2 2024 were $42.96 million, compared to $30.18 million in Q2 2023 [8] Balance Sheet Overview - As of June 30, 2024, total assets were $276.93 million, down from $344.43 million at the end of 2023, while total liabilities decreased to $72.00 million from $78.91 million [9]

Core Viewpoint - HilleVax, Inc. is under investigation for potential securities fraud and unlawful business practices following the failure of its clinical trial for HIL-214, which did not meet its primary efficacy endpoint [1][2]. Group 1: Clinical Trial Results - On July 8, 2024, HilleVax announced topline data from the NEST-IN1 Phase 2b clinical trial, which evaluated the efficacy, safety, and immunogenicity of HIL-214 in infants [2]. - The trial did not meet its primary endpoint of efficacy against moderate or severe acute gastroenteritis events due to GI.1 or GII.4 norovirus genotypes, and no clinical benefit was observed across secondary endpoints [2]. Group 2: Stock Market Reaction - Following the announcement of the clinical trial results, HilleVax's stock price fell by $12.42 per share, representing an 88.3% decline, closing at $1.64 per share on July 8, 2024 [4]. Group 3: Legal Investigation - Pomerantz LLP is investigating claims on behalf of HilleVax investors regarding potential securities fraud or other unlawful business practices by the company and its officers or directors [1].

Core Viewpoint - HilleVax, Inc. is under investigation for potential securities fraud and unlawful business practices following the failure of its clinical trial results, which led to a significant drop in its stock price [5][6][3]. Group 1: Company Overview - HilleVax, Inc. is a publicly traded company on NASDAQ under the ticker HLVX [1]. - The company recently announced topline data from its Phase 2b clinical trial, NEST-IN1, which aimed to evaluate the efficacy of its product HIL-214 in infants [6]. Group 2: Clinical Trial Results - The NEST-IN1 trial did not meet its primary endpoint of efficacy against moderate or severe acute gastroenteritis events caused by specific norovirus genotypes [6]. - No clinical benefit was observed across secondary endpoints in the trial [6]. Group 3: Stock Market Reaction - Following the announcement of the trial results, HilleVax's stock price plummeted by $12.42 per share, representing an 88.3% decrease, closing at $1.64 per share on July 8, 2024 [3]. Group 4: Legal Investigation - Pomerantz LLP is investigating claims on behalf of HilleVax investors regarding potential securities fraud or other unlawful business practices by the company and its officers [5].

Group 1 - HilleVax, Inc. (HLVX) has experienced significant selling pressure, resulting in an 88.8% loss over the past four weeks, but analysts expect better earnings than previously predicted [1] - The stock is currently in oversold territory, indicated by a Relative Strength Index (RSI) reading of 15.88, suggesting a potential reversal in trend [5] - There has been a 19.2% increase in the consensus EPS estimate for HLVX over the last 30 days, driven by a strong agreement among sell-side analysts to raise earnings estimates [6] Group 2 - HLVX holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, indicating a potential turnaround [7]

Core Viewpoint - HilleVax, Inc. is under investigation following the failure of its sole clinical-stage candidate, HIL-214, in a phase 2b trial, leading to significant losses for shareholders [4]. Group 1: Company Overview - HilleVax, Inc. is a biotech company listed on NASDAQ under the ticker HLVX [4]. - The company focuses on developing vaccines, with its primary candidate being HIL-214, aimed at norovirus-related acute gastroenteritis [4]. Group 2: Trial Results - HIL-214 failed to meet all primary and secondary endpoints in the NEST-IN1 study, which involved over 2,800 infants approximately five months old in the U.S. and Latin America [4]. - The failure of this trial has resulted in a significant decline in HilleVax's stock price, causing damages to shareholders [4]. Group 3: Legal Investigation - Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of investors who purchased HilleVax securities [1]. - The firm encourages affected investors to provide information and assist in the investigation [8]. - The firm operates on a contingency fee basis, meaning they will only recover costs if successful in the claims [3].

The double-blind, placebo-controlled study evaluated the efficacy, safety and immunogenicity of HIL-214 in infants around five months old. Shares of the company were down 88.3% on Jul 8 following the announcement of the news. The stock has plunged 89.8% so far this year compared with the industry's decrease of 7.9%. HilleVax, Inc. (HLVX) announced that its phase IIb NEST-IN1 study, evaluating its investigational virus-like particle-based vaccine candidate, HIL-214, in infants for the prevention of acute gas ...

Loading... The Dow traded down 0.12% to 39,329.47 while the NASDAQ rose 0.27% to 18,401.75. The S&P 500 also rose, gaining, 0.09% to 5,572.23. Leading and Lagging Sectors In trading on Monday, communication services shares fell by 0.9%. Eli Lilly And Co LLY agreed to acquire Morphic Holding Inc MORF for $57 per share in cash, an aggregate of approximately $3.2 billion. Morphic Holding, Inc. MORF shares shot up 75% to $55.85 after Eli Lilly agreed to buy the company for $57 per share in cash. Shares of Myomo ...

How This Affects HLVX Stock Read More:Penny Stocks — How to Profit Without Getting Scammed HilleVax (NASDAQ:HLVX) stock is falling hard on Monday following the release of topline data from its Phase 2b clinical trial of HIL-214 in infants. HilleVax CEO Rob Hershberg said the following about the news. Shares of HLVX stock are taking a beating alongside heavy trading today. This has more than 17 million shares traded as investors offload the stock on the failed clinical trial news. To put that number in persp ...

Loading... Monday, the company released topline data results from the NEST-IN1 Phase 2b randomized, double-blind, placebo-controlled trial of the efficacy, safety, and immunogenicity of HIL-214 in infants approximately five months of age at the time of initial vaccination. In the NEST-IN1 study, there were 51 primary endpoint events, with 25 in the vaccine arm (n=1,425) and 26 in the placebo arm (n=1,399), resulting in a vaccine efficacy of 5%. "We are disappointed that the NEST-IN1 study did not meet its p ...