On November 06, 2024 Sonnet BioTherapeutics Holdings, Inc. (the "Company" or "Sonnet") (NASDAQ: SONN), a clinical-stage company developing innovative targeted immunotherapeutic drugs, reported the pricing of an underwritten public offering of 1,111,111 shares of common stock (or pre-funded warrants to purchase shares of common stock in lieu of shares of common stock) and common warrants to purchase up to an aggregate of 2,222,222 shares of common stock (Press release, Sonnet BioTherapeutics, NOV 6, 2024, View Source [SID1234647831]). Each share of common stock (or pre-funded warrant in lieu thereof) is being sold together with one common warrant at a combined offering price of $4.50, priced at-the-market under the rules of the Nasdaq Stock Market, for total gross proceeds of approximately $5.0 million, before underwriting discounts and commissions and offering expenses payable by Sonnet. Each common warrant is exercisable for two shares of common stock at an exercise price of $4.50 per share for a period of five years from the date of issuance. The offering is expected to close on or about November 7, 2024, subject to the satisfaction or waiver of customary closing conditions.

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Chardan is acting as the underwriter in connection with the offering.

Sonnet anticipates using the net proceeds from the offering for research and development, including clinical trials, working capital, the repayment of all or a portion of Sonnet’s liabilities, and general corporate purposes.

The securities will be offered pursuant to a registration statement on Form S-1, as amended (File No. 333-282850), which was declared effective by the Securities and Exchange Commission (the "SEC") on November 6, 2024. The offering is being made solely by means of a prospectus. A preliminary prospectus relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus and, when available, copies of the final prospectus relating to this offering can be obtained at the SEC’s website at www.sec.gov or from Chardan Capital Markets, LLC, 17 State Street, Suite 2130, New York, New York 10004, at (646) 465-9000, or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

On November 6, 2024 Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) (the "Company" or "Sonnet"), a clinical-stage company developing targeted immunotherapeutic drugs, reported that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 12,134,635 entitled "Interleukin 18 (IL-18) Variants and Fusion Proteins Comprising Same," covering two of its novel drug candidates, SON-1411 (IL-18BPR-FHAB-IL12) and SON-1400 (IL-18BPR-FHAB), each containing a modified version of recombinant human interleukin-18 (IL-18BPR = Binding Protein Resistant) (Filing, Sonnet BioTherapeutics, NOV 6, 2024, View Source [SID1234647830]). The patent carries a term effective until June 2044.

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"The issuance of this intellectual property is an important milestone that we believe provides significant differentiation from competitors trying to tap the full biological potential of IL-18, either alone or in combination with IL-12. IL-18 is a key cytokine that, when combined synergistically with IL-12, has the potential to be an important therapeutic asset for oncology and cell-based therapy," commented Pankaj Mohan, Ph.D., Sonnet Founder and Chief Executive Officer.

SON-1411 is a proprietary bifunctional fusion protein consisting of IL-18BPR combined with single-chain wild-type IL-12, linked to Sonnet’s Fully Human Albumin Binding (FHAB) platform, which has replaced SON-1410 as a development target. SON-1400 is a monofunctional fusion protein comprising the same IL-18BPR domain linked to the FHAB. FHAB extends the half-life and biological activity of linked molecules by binding native albumin in the serum and targets the tumor microenvironment (TME) through high affinity binding to glycoprotein 60 (gp60) and the Secreted Protein Acidic and Rich in Cysteine (SPARC).

IL-18 can regulate both innate and adaptive immune responses through its effects on natural killer (NK) cells, monocytes, dendritic cells, T cells, and B cells. IL-18 acts synergistically with other pro-inflammatory cytokines to promote interferon-γ (IFN-γ) production by NK cells and T cells. Systemic administration of IL-18 has been shown to have anti-tumor activity in several animal models. Moreover, tumor-infiltrating lymphocytes (TILs) express more IL-18 receptors than other T cells. However, IL-18 clinical trials have shown that, although it is well tolerated, IL-18 has poor efficacy in the treatment of cancers, most likely due in large part to the high co-expression of IL-18 binding protein (IL-18BP) in the TME. In particular, IL-18BP serves as a "decoy receptor" that binds to IL-18 with higher affinity, compared with the IL-18Rc complex, thereby causing a negative feedback loop with IL-18 and inhibiting IL-18-mediated TIL activation. Thus, there exists a potential for the discovery of IL-18 variant compositions that could harness the therapeutic potential of IL-18 for the treatment of cancers.

Sonnet’s strategy for amino acid modifications to rIL-18 was based on a compilation of literature review, 3D X-ray crystallography structures, and computer modeling analysis. Subsequently, certain IL-18 variant sequences were synthesized, engineered into expression constructs and manufactured at small scale in either CHO cell culture or E. coli. Highly purified milligram quantities of SON-1411 or SON-1400 were analyzed in vitro for IL-18Rc or IL-18BP binding activities, respectively, using the HEK-Blue and Bright-Glo Luciferase IL-18Rc reporter assays. In vitro results for at least one variant of IL-18 showed equivalent binding to the IL-18 Rc, compared to the wild-type IL-18 reference molecule, concomitant with no or reduced binding to IL-18BP.

The known MOA of IL-18 inhibition by IL-18BP is reviving the importance of clinical applications of IL-18. IL-18BP has been shown to be elevated in cancer patients, thus nullifying the clinical applications of IL-18. Sonnet is developing two novel bifunctional cytokine molecules, IL-18BPR-FHAB-IL12 and IL-18BPR-FHAB, both of which contain a unique IL-18 domain that does not bind the inhibitor IL-18BP but still maintains full IL-18 and IL-12 bioactivity. The clinical application of these mono or bifunctional fusion proteins could potentially expand immunotherapy applications for cancer patients.

About SON-1411

SON-1411 is a candidate immunotherapeutic recombinant drug that is closely related to and has replaced SON-1410. SON-1410 links an unmodified single-chain human IL-18 and an unmodified IL-12 with the albumin-binding domain of the single-chain antibody fragment A10m3. The key difference between SON-1410 and SON-1411 is that in the latter, there has been novel modification of the IL-18 domain via mutagenesis to retain wildtype binding to the IL-18 receptor (IL-18 Rc) while inhibiting or abolishing binding to the IL-18 binding protein (IL-18 BP). The A10m3 scFv was selected to bind both at normal pH, as well as at the acidic pH that is typically found in the TME. The FHAB technology targets tumor and lymphatic tissue, providing a mechanism for dose sparing and an opportunity to improve the safety and efficacy profile of IL-18 and IL-12, as well as a variety of potent immunomodulators that can be added using the platform. Interleukin-12 can orchestrate a robust immune response to many cancers and pathogens. Given the types of proteins induced in the TME, such as SPARC and gp60, several types of cancer such as non-small cell lung cancer, melanoma, head and neck cancer, sarcoma, and some gynecological cancers are particularly relevant for this approach. SON-1411 is designed to deliver IL-18BPR and IL-12 to local tumor tissue, turning ‘cold’ tumors ‘hot’ by stimulating IFNγ, which activates innate and adaptive immune cell responses and increases the production of Programed Death Ligand 1 (PD-L1) on tumor cells.

On November 6, 2024 Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for patients with RAS-addicted cancers, reported its financial results for the quarter ended September 30, 2024, and provided an update on corporate progress (Press release, Revolution Medicines, NOV 6, 2024, View Source [SID1234647829]).

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The company is committed to revolutionizing treatment for patients with RAS-addicted cancers through the discovery, development and delivery of innovative, targeted medicines across lines of therapy and tumor types.

"We’ve made enormous progress on behalf of patients against this year’s strategic priorities, having now demonstrated encouraging clinical results for our three pioneering clinical-stage RAS(ON) inhibitors. Recently updated data for RMC-6236 continued to elaborate its compelling clinical profile, including highly encouraging progression-free survival and overall survival in patients with previously treated pancreatic cancer, and a Phase 3 pivotal study is now underway. A first report on RMC-9805 showcased its encouraging initial clinical profile in patients with KRAS G12D pancreatic cancer, marking the first oral, covalent, mutant-selective investigational drug to show initial promise in patients with tumors harboring this common mutation," said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. "We believe these are major milestones on our path toward serving patients with RAS-addicted cancers, and we expect to provide additional updates before year-end that should help set the stage for continued pipeline progress in our multilayered approach in 2025."

Recent Clinical Highlights & Upcoming Milestones

Pancreatic Cancer
The company currently has two RAS(ON) inhibitors being developed for patients with advanced or metastatic PDAC, RMC-6236, a RAS(ON) multi-selective inhibitor, and RMC-9805, a RAS(ON) G12D-selective inhibitor. The company is currently evaluating both compounds as monotherapy and in combination regimens.

RMC-6236 Clinical Updates

On October 21, 2024, the company reported that the first patient was dosed in RASolute 302, a Phase 3 registrational study evaluating RMC-6236 compared with standard-of-care chemotherapy in patients with previously treated metastatic PDAC. Timing of RASolute 302 data readout will be event-driven after the study is fully enrolled.
On October 23, 2024, the company reported updated clinical safety/tolerability and efficacy data from its ongoing RMC-6236 monotherapy study at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics (Triple meeting) in Barcelona. As of the July 23, 2024 data cutoff date, RMC-6236 demonstrated compelling antitumor activity, including encouraging progression-free survival (median 8.5 months) and overall survival (median 14.5 months) among second-line PDAC patients with tumors harboring a KRAS G12X mutation who received doses from 160 mg to 300 mg daily. The safety/tolerability findings were generally consistent with previously reported data, and no new safety signals were observed.
RMC-9805 Clinical Updates

On October 25, 2024, the company reported initial safety/tolerability and antitumor activity data from the RMC-9805 monotherapy dose-escalation study in patients with KRAS G12D tumors at the Triple meeting. As of the September 2, 2024 data cutoff date, RMC-9805 demonstrated an encouraging safety and tolerability profile among patients treated at all dose levels and across tumor types and showed encouraging initial antitumor activity in patients with PDAC treated at multiple dose levels and particularly among those who received 1200 mg once daily or 600 mg twice daily; 1200 mg once daily is a candidate recommended Phase 2 dose and schedule.
Evaluation of RMC-9805 in combination with RMC-6236 in a Phase 1 study is ongoing in patients with KRAS G12D solid tumors.
Beyond Pancreatic Cancer:
The company is currently evaluating its clinical-stage RAS(ON) inhibitors as monotherapy and/or combinations in patients with additional solid tumors carrying RAS mutations.

Upcoming Milestones

The company plans to provide updated data from its ongoing study of RMC-6236 monotherapy in patients with NSCLC in the fourth quarter of 2024. The company currently expects to reach regulatory alignment and initiate a Phase 3 registrational study evaluating RMC-6236 as monotherapy in patients with previously treated, advanced RAS-mutant NSCLC in the first quarter of 2025.

The company also plans to share initial clinical pharmacokinetics (PK), safety/tolerability and antitumor activity data from a combination study evaluating RMC-6236 with pembrolizumab in the fourth quarter of 2024.

Evaluation of the company’s RAS(ON) doublet combination of RMC-6291 with RMC-6236 is ongoing, and the company currently expects to disclose initial clinical PK, safety/tolerability and antitumor activity data from this combination study in the fourth quarter of 2024.

The company is evaluating the combination of RMC-6291 with pembrolizumab, with or without chemotherapy, in patients with advanced NSCLC, and currently expects to disclose initial clinical PK, safety/tolerability and antitumor activity data from this combination study in the first half of 2025.
Financial Highlights

Third Quarter Results

Cash Position: Cash, cash equivalents and marketable securities were $1.55 billion as of September 30, 2024.

R&D Expenses: Research and development expenses were $151.8 million for the quarter ended September 30, 2024, compared to $107.7 million for the quarter ended September 30, 2023. The increase in expense was primarily due to increases in clinical trial expenses for RMC-6236, RMC-6291 and RMC-9805, personnel-related expenses related to additional headcount and stock-based compensation expense.

G&A Expenses: General and administrative expenses were $24.0 million for the quarter ended September 30, 2024, compared to $15.5 million for the quarter ended September 30, 2023. The increase was primarily due to increases in personnel-related expenses associated with additional headcount, commercial preparation activities and stock-based compensation expense.

Net Loss: Net loss was $156.3 million for the quarter ended September 30, 2024, compared to net loss of $108.4 million for the quarter ended September 30, 2023.

Financial Guidance
Revolution Medicines is reiterating projected full year 2024 GAAP net loss guidance of between $560 million and $600 million, which includes estimated non-cash stock-based compensation expense of between $70 million and $80 million. Based on the company’s current operating plan, the company projects current cash, cash equivalents and marketable securities can fund planned operations into 2027.

Webcast
Revolution Medicines will host a webcast this afternoon, November 6, 2024, at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). To listen to the live webcast, or access the archived webcast, please visit: View Source Following the live webcast, a replay will be available on the company’s website for at least 14 days.

On November 6, 2024 Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies, reported third quarter 2024 financial results and recent corporate highlights (Press release, Relay Therapeutics, NOV 6, 2024, View Source [SID1234647828]).

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"In the third quarter, we reported very encouraging interim data showing that RLY-2608 + fulvestrant led to clinically meaningful progression free survival in heavily pre-treated patients with PI3Kα-mutated, HR+, HER2- metastatic breast cancer," said Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics. "Based on these data, we are preparing to initiate a pivotal trial in 2L breast cancer in 2025, which we expect to be able to fully fund through top-line readout with our existing cash on hand. We also continue to progress our pre-clinical programs and look forward to bringing new programs into the clinic in 2025."

Recent Corporate Highlights

RLY-2608 (ReDiscover study)

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RLY-2608 doublet:
o
Reported interim data for RLY-2608 + fulvestrant in patients with PI3Kα-mutated, HR+, HER2- metastatic breast cancer who had previously received at least one prior CDK4/6 inhibitor. The data demonstrated clinically meaningful progression free survival (PFS) at the company’s recommended Phase 2 dose (RP2D) of 600mg BID. The cut-off date for these data was August 12, 2024. Key highlights included:
▪
9.2-month median PFS across all mutations & 10.3 months among patients with kinase mutations
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33% objective response rate (ORR) across all patients & 53% ORR in patients with kinase mutations at the RP2D
▪
Favorable overall tolerability profile; at RP2D, only two patients discontinued treatment due to adverse events & only 1 patient experienced Grade 3 hyperglycemia

▪
RLY-2608 + fulvestrant data will be presented at the San Antonio Breast Cancer Symposium, taking place December 10-13, 2024. Details of the poster spotlight presentation are as follows:
•
Abstract Title: PS7-01: Efficacy of RLY-2608, a mutant-selective PI3Kα inhibitor in patients with PIK3CA-mutant HR+HER2- advanced breast cancer: ReDiscover trial
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Abstract Number: SESS-2211
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Session: Concurrent Poster Spotlight Session 7: Targeting the ER and PI3K pathway: Novel drugs and combinations
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Date/Time: Wednesday, December 11, 8:00-9:30 a.m. ET (7:00-8:30 a.m. CT)
o
Data support planned initiation of Phase 3 pivotal trial for RLY-2608 + fulvestrant in 2025
•
RLY-2608 triplet: Continued to progress two potential front-line triplet regimens in patients with PI3Kα-mutated, HR+, HER2- metastatic breast cancer who had previously received at least one prior CDK4/6 inhibitor, including:
o
CDK4/6: RLY-2608 + ribociclib + fulvestrant dose escalation is currently testing biologically active doses of RLY-2608 and is on track to identify a dose of RLY-2608 that is combinable with full-dose ribociclib. Expansion cohorts are expected to initiate in the first half of 2025
o
CDK4: RLY-2608 + atirmociclib + fulvestrant trial on track to initiate by the end of 2024
Lirafugratinib (RLY-4008)

•
Presented updated FGFR2 fusion tumor agnostic data at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), October 23-25, 2024
•
Provided regulatory update regarding lirafugratinib regulatory path in which the FDA suggested that the company first file a new drug application (NDA) in cholangiocarcinoma, followed by a tumor agnostic supplemental NDA for FGFR2 fusions with data from more patients and more follow up
•
Disclosed plans to seek a global commercialization partner for lirafugratinib in order to maintain company’s focus on the remainder of the portfolio
Corporate Highlights

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Raised $230 million of gross proceeds in an underwritten follow-on public offering in September 2024
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Completed series of changes to streamline the research organization, collectively resulting in an expected $50 million in annual savings and workforce reduction of approximately 15%. Changes are part of the company’s shift to becoming more development-focused in preparation for the upcoming RLY-2608 pivotal trial as well as new programs entering the clinic over the course of 2025

Anticipated Upcoming Milestones

•
Breast Cancer
o
RLY-2608 + fulvestrant + ribociclib initial safety data in the fourth quarter of 2024
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RLY-2608 + fulvestrant + atirmociclib clinical trial initiation by the end of 2024
o
RLY-2608 + fulvestrant + ribociclib dose expansion initiation in the first half of 2025
o
RLY-2608 + fulvestrant 2L Phase 3 trial initiation in 2025
•
Pre-clinical
o
Vascular malformations: RLY-2608 clinical trial initiation in the first quarter of 2025
o
Fabry disease: clinical start in the second half of 2025
o
NRAS: clinical start in the second half of 2025

Third Quarter 2024 Financial Results

Cash, Cash Equivalents and Investments: As of September 30, 2024, cash, cash equivalents and investments totaled $839.6 million compared to $750.1 million as of December 31, 2023. The company expects its current cash, cash equivalents and investments will be sufficient to fund its current operating plan into the second half of 2027.

Revenue: Revenue was $0 for the third quarter of 2024, as compared to $25.2 million for the third quarter of 2023. The decrease was primarily due to the recognition of previously received milestone payments under the company’s Collaboration and License Agreement with Genentech, Inc. during the third quarter of 2023.

R&D Expenses: Research and development expenses were $76.6 million for the third quarter of 2024, as compared to $81.5 million for the third quarter of 2023. The decrease was primarily due to the impact of prioritization of certain programs in the company’s pipeline, as previously disclosed in 2023 and earlier in 2024.

G&A Expenses: General and administrative expenses were $19.8 million for the third quarter of 2024, as compared to $18.5 million for the third quarter of 2023. The increase was primarily due to an increase in stock compensation expense, partially offset by decreases in other employee compensation costs and certain other general and administrative expenses.

Net Loss: Net loss was $88.1 million for the third quarter of 2024, or a net loss per share of $0.63, as compared to a net loss of $65.7 million for the third quarter of 2023, or a net loss per share of $0.54.

On November 6, 2024 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported results for the third quarter and first nine months of 2024 (Press release, Qiagen, NOV 6, 2024, View Source [SID1234647827]).

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Net sales rose 5% to $502 million in Q3 2024 over Q3 2023, while results at constant exchanges rates (CER) of $502 million rose 6% and were above the outlook for at least $495 million CER. The adjusted operating income margin rose three percentage points to 29.6% on benefits from the recent decision to discontinue the NeuMoDx system as well as broader efficiency gains that have improved profitability and freed up resources for targeted reinvestment. Adjusted diluted earnings per share (EPS) were $0.57, and results at CER of $0.58 were above the outlook for at least $0.55 CER.

QIAGEN has reaffirmed its FY 2024 sales outlook for at least $1.985 billion CER based on the solid core business performance in the first nine months of the year. The outlook for adjusted diluted EPS has been increased to at least $2.19 CER (previously $2.10 CER at start of 2024), while the adjusted operating income margin target has been reaffirmed for at least 28.5% compared to 26.9% in 2023.

"QIAGEN delivered another solid performance in the third quarter of 2024, exceeding our goals for net sales and adjusted earnings thanks to the strong trends in our business and the resilience of our portfolio with over 85% of sales from highly recurring revenues. We are executing quarter after quarter in this challenging macro environment on delivering sales growth combined with market share gains and operational efficiency thanks to a differentiated portfolio," said Thierry Bernard, CEO of QIAGEN.

"The value of our portfolio was again underscored with three QIAGEN customers recently being awarded Nobel Prizes for their groundbreaking contributions to advancing science and improving healthcare. Our teams are constantly enhancing this portfolio, and recent developments include the launch of 100 new assays for the QIAcuity digital PCR system along with the new QIAcuityDx version for clinical applications. We have expanded the utility of our QIAstat-Dx system beyond syndromic testing through new pharma partnerships with AstraZeneca and Eli Lilly. This progress in 2024 to achieve our goals marks a key step toward achieving our 2028 targets and delivering on our commitment to solid profitable growth," Bernard said.

"Our 2024 results to date reflect a positive quarterly trend in sales and adjusted earnings, along with a 73% increase in free cash flow. We are well-positioned to achieve the updated outlook for 2024 as we once again increase our adjusted EPS target," said Roland Sackers, CFO of QIAGEN. "We are implementing initiatives to simplify QIAGEN and increase efficiency, and these initiatives are putting us on track to increase our adjusted operating income margin above 31% by the end of 2028, reaffirming our commitment to solid profitable growth."

Please find the full press release incl. tables as a PDF for download at the top of this page.
Investor presentation and conference call

A conference call is planned for Thursday, November 7, 2024 at 15:30 Frankfurt Time / 14:30 London Time / 9:30 New York Time. A live audio webcast will be made available in the investor relations section of the QIAGEN website, and a recording will also be made available after the event. A presentation will be available before the conference call at View Source