Hexavalent Recombinant Norovirus vaccine (Kanghua Biological)

$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 MaltbieIR@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

The industry heat has forced three biotechs to slim down on staff. As biotechs attempt to turn a fresh page in August, at least three companies have shed staff in attempts to forge on.  First up is gene therapy company UniQure. The business is undergoing an organizational restructuring designed to streamline operations, according to an Aug. 1 release on the company's second-quarter financial results.The streamlining strategy is expected to slash global headcount by 65%, or 300 roles—cuts that include the recent sale of a Massachusetts manufacturing facility to Genezen. That sale is also tied to the departure of Chief Operating Officer Pierre Caloz, who helped UniQure establish commercial manufacturing capabilities for Hemgenix, an approved hemophilia B gene therapy.Amin Abujoub, Ph.D., who previously served as the biopharma’s chief quality officer, is taking on the new role of chief technical operations officer, which will include global oversight of contract manufacturers. The restructure is expected to be complete in the fourth quarter of this year and slash recurring costs by 40%, or $75 million annually. As of June 30, UniQure had $524 million on hand, money expected to stretch to the end of 2027, according to the company release.“These actions are designed to ensure we have the funding required to achieve key milestones and drive shareholder value, as we endeavor to deliver transformative medicines to patients in need,” uniQure CEO Matt Kapusta said in the release.Some of those milestones center around AMT-130, the company’s investigational gene therapy for Huntington’s disease. The asset is currently being studied in a phase 1/2 trial, with a recent interim data drop revealing a slowing in disease progression.The FDA also granted the candidate regenerative medicine advanced therapy designation, and UniQure expects to meet with the FDA in the second half of this year about potentially pursuing an expedited clinical development path, according to Kapusta. Clinical-stage Arbutus Biopharma follows suit, with a “decision to streamline the organization” to advance two clinical programs, leaving a mid-stage trial and 40% of staff in its wake.The layoffs will mainly impact discovery roles, plus general and administrative functions, according to an Aug. 1 release on second-quarter financial results.Arbutus will zero in on phase 2b development of imdusiran, an RNA interference therapeutic made to reduce hepatitis B virus (HBV) viral proteins and antigens, as well as AB-101, an oral PD-L1 inhibitor being evaluated in an early-stage trial for chronic HBV.Meanwhile, the company will discontinue HBV research efforts and a phase 2a clinical trial dubbed IM-PROVE III. The study was assessing imdusiran in combination with anti-PD-L1 durvalumab, among patients with chronic HBV. The study had an estimated enrollment of 30 patients and expected readout slated for 2027, according to ClinicalTrials.gov. This decision to terminate the trial was “based on a prioritization of resources and the projected availability of clinical data from this trial,” according to the company's release. The reorganization is expected to extend the company’s cash runway into the final quarter of 2026.It’s the second layoff round within a year for the biotech. In November 2023, the company let go of 24% of its team after redirecting money for research programs toward clinical efforts. Last up today is Takeda spinout HilleVax. The vaccine-focused biotech revealed a 40% workforce reduction after market close yesterday. The layoffs will impact about 41 employees and is designed to reduce operating costs.The move is made so HilleVax can explore “the potential for continued development of its HIL-214 and HIL-216 norovirus vaccine candidates, as well as business development-related activities for these vaccine candidates,” according to the July 31 release. In early July, HIL-214—the company’s sole clinical-stage candidate—failed a phase 2b trial in norovirus-related acute gastroenteritis.The virus-like particle-based vaccine missed all primary and secondary endpoints of the study which included more than 2,800 infants, showing an efficacy of just 5%.