On November 4, 2024 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported financial results for the three and nine months ended September 30, 2024 and provided an update on its corporate progress (Press release, BioNTech, NOV 4, 2024, View Source [SID1234648550]).

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"BioNTech’s achievements during the period were the successful launch of our variant-adapted COVID-19 vaccines and the progress across our oncology pipeline. In particular, we initiated later-stage trials and shared important updates for our PD-L1 x VEGF-A bispecific antibody candidate BNT327/PM8002 and for our mRNA cancer vaccine portfolio. These successes reinforce the potential of our multi-platform technology approach and inform our strategy to pursue novel proprietary combinations," said Prof. Ugur Sahin, M.D., CEO and Co-Founder of BioNTech. "We remain focused on advancing our late-stage oncology product candidates towards potential registration. We believe our pipeline and capabilities uniquely position us to execute on our vision of becoming a global multiproduct immunotherapy company."

Financial Review for Third Quarter and Nine Months of 2024

in millions €, except per share data Third Quarter 2024 Third Quarter 2023 Nine Months
2024 Nine Months
2023
Revenues 1,244.8 895.3 1,561.1 2,340.0
Net profit / (loss) 198.1 160.6 (924.8) 472.4
Diluted earnings / (loss) per share 0.81 0.66 (3.83) 1.94
Revenues reported were €1,244.8 million for the three months ended September 30, 2024, compared to €895.3 million for the comparative prior year period. For the nine months ended September 30, 2024, revenues were €1,561.1 million, compared to €2,340.0 million for the comparative prior year period. The higher revenues in the third quarter of 2024 as compared to the comparative prior year period can be largely attributed to the earlier approvals received for its variant-adapted COVID-19 vaccines as compared to last year.

Cost of sales were €178.9 million for the three months ended September 30, 2024, compared to €161.8 million for the comparative prior year period. For the nine months ended September 30, 2024, cost of sales were €297.8 million, compared to €420.7 million for the comparative prior year period.

Research and development ("R&D") expenses were €550.3 million for the three months ended September 30, 2024, compared to €497.9 million for the comparative prior year period. For the nine months ended September 30, 2024, R&D expenses were €1,642.4 million, compared to €1,205.3 million for the comparative prior year period. R&D expenses were mainly influenced by progressing clinical studies for the Company’s late-stage oncology pipeline candidates.

Sales, general and administrative ("SG&A") expenses2, in total, amounted to €150.5 million for the three months ended September 30, 2024, compared to €153.5 million for the comparative prior year period. For the nine months ended September 30, 2024, SG&A expenses were €466.9 million, compared to €415.4 million for the comparative prior year period. SG&A expenses were mainly influenced by personnel expenses.

Other operating result amounted to negative €354.6 million during the three months ended September 30, 2024, compared to negative €9.0 million for the comparative prior year period. For the nine months ended September 30, 2024, other operating result amounted to negative €616.9 million compared to negative €134.4 million for the prior year period. Other operating result was primarily influenced by provisions for contractual disputes.

Income taxes were realized with an amount of €39.4 million in tax income for the three months ended September 30, 2024, compared to €66.8 million in accrued tax expenses for the comparative prior year period. For the nine months ended September 30, 2024, income taxes were realized with an amount of €54.1 million in tax income for the nine months ended September 30, 2024, compared to €50.5 million of accrued tax expenses for the comparative prior year period.

Net profit was €198.1 million for the three months ended September 30, 2024, compared to €160.6 million net profit for the comparative prior year period. For the nine months ended September 30, 2024, net loss was €924.8 million, compared to a net profit of €472.4 million for the comparative prior year period.

Cash and cash equivalents plus security investments as of September 30, 2024, reached €17,839.8 million, comprising €9,624.6 million in cash and cash equivalents, €7,078.0 million in current security investments and €1,137.2 million in non-current security investments.

Diluted earnings per share was €0.81 for the three months ended September 30, 2024, compared to €0.66 for the comparative prior year period. For the nine months ended September 30, 2024, loss per share was €3.83, compared to diluted earnings per share of €1.94 for the comparative prior year period.

Shares outstanding as of September 30, 2024, were 239,739,752, excluding 8,812,448 shares held in treasury.

"We successfully launched our variant-adapted COVID-19 vaccines upon receipt of earlier approvals as compared to last year. This drove our strong revenues in the third quarter," said Jens Holstein, CFO of BioNTech. "Our cost discipline in combination with our financial position allow us to continue to focus on those assets that we believe offer a fast path to market and the highest potential to generate value for patients and shareholders."

2024 Financial Year Guidance3

The Company expects its revenues for the full 2024 financial year to be at the low end of the guidance range provided in its outlook:

Total revenues for the 2024 financial year low end of €2.5 billion – €3.1 billion
The range reflects certain assumptions and expectations, including, but not limited to: COVID-19 vaccine uptake and price levels, including seasonal variations; inventory write-downs and other charges by BioNTech’s collaboration partner Pfizer Inc. ("Pfizer") that negatively influence BioNTech’s revenues; anticipated revenues from a pandemic preparedness contract with the German government; and revenues from the BioNTech Group service businesses, namely InstaDeep Ltd ("InstaDeep"), JPT Peptide Technologies GmbH, and BioNTech Innovative Manufacturing Services GmbH. Generally, the Company continues to remain largely dependent on revenues generated in its collaboration partner’s territories in 2024.

2024 Financial Year Expenses and Capex

The Company has reduced its previous guidance for expected SG&A expenses and capital expenditures for operating activities for the 2024 financial year:

Guidance March 2024 Guidance November 2024
R&D expenses4 €2,400 million – €2,600 million €2,400 million – €2,600 million
SG&A expenses €700 million – €800 million €600 million – €700 million
Capital expenditures for operating activities €400 million – €500 million €300 million – €400 million
The full interim unaudited condensed consolidated financial statements can be found in BioNTech’s Report on Form 6-K for the period ended September 30, 2024, filed today with the United States Securities and Exchange Commission ("SEC") and available at View Source

On November 4, 2024 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported five posters, including a Spotlight poster presentation, at the San Antonio Breast Cancer Symposium (SABCS ) 47th Annual Meeting, being held December 10 – 13 , 2024, at the Henry B. Gonzalez Convention Center, San Antonio, Texas (Press release, BriaCell Therapeutics, NOV 4, 2024, View Source [SID1234648540]).

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"At BriaCell, we remain committed to advancing our novel therapies to improve cancer patients’ lives," stated William V. Williams, MD, BriaCell’s President & CEO. "Having five poster presentations, including a spotlight poster, attests to the depth and breadth of our research and clinical development efforts at BriaCell. We look forward to sharing our data with scientific experts and cancer specialists seeking better clinical outcomes."

The details about the Spotlight presentation and other poster sessions are as follows:

Abstract Number: SESS-1071 (Spotlight Poster)
Title: Overall survival results of Bria-IMT allogenic whole cell-based cancer vaccine
Time: Wednesday, December 11, 2024 7:00 AM – 8:30 AM CST
Presentation ID: PS3-06

Abstract Number: SESS-1431
Title: Identification of antigenic determinants in SV-BR-1 derived cellular breast cancer vaccines
Time: Wednesday, December 11, 2024 5:30 – 7:00 PM CST
Presentation ID: P2-06-02

Abstract Number: SESS-2217
Title: PD-L1 upregulation in circulating tumor associated cells predicts for clinical outcomes in a phase I/II clinical trial using SV-BR-1-GM vaccine with the checkpoint inhibitor retifanlimab in metastatic breast cancer patients, an interim analysis
Time: Wednesday, December 11, 2024 12:00 – 2:00 PM CST
Presentation ID: P1-01-17

Abstract Number: SESS-1068
Abstract Title: ASTRO-VAC CNS: Bria-IMT in the management of tumor agnostic metastatic CNS lesions
Time: Wednesday, December 11, 2024 5:30 – 7:00 PM CST
Presentation ID: P2-10-24

Abstract Number: SESS-1069
Title: Bria-IMT CD8+ tumor infiltrating lymphocytes turn "Cold" tumor "Hot" in metastatic breast cancer
Time: Friday, December 13, 2024 12:00 PM – 2:00 PM CST
Presentation ID: P5-10-12

Following the presentation, copies of the posters will be posted on View Source

On November 4, 2024 Synaffix B.V. ("Synaffix"), a Lonza company (SWX:LONN) focused on commercializing its clinical-stage platform technology for the development of antibody-drug conjugates (ADCs) with best-in-class therapeutic index, reported that it has licensed its ADC technology to BigHat Biosciences, Inc. ("BigHat") (Press release, Synaffix, NOV 4, 2024, View Source [SID1234648078]). BigHat will combine Synaffix technology with its world-class ML antibody design platform for the development of a new ADC pipeline program.

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Under the terms of the agreement, BigHat will receive target-specific access to Synaffix’s late-clinical stage, site-specific ADC technology platform, which enables the transformation of antibodies into proprietary, best-in-class ADC products. As a result of Lonza’s acquisition of Synaffix in June 2023, BigHat will also gain access to Lonza’s end-to-end ADC offering. This DNA-to-IND offering enables drug developers to seamlessly receive all necessary cGMP/non-cGMP ADC batches leading up to the first clinical trial under a single quality system encompassing all critical development and manufacturing activities, including the production of the antibody, bioconjugation, and drug product filling.

BigHat’s AI/ML-powered antibody design platform, Milliner, integrates a synthetic biology-based high-speed wet lab with state-of-the-art ML technologies into a full-stack antibody discovery and engineering platform, to engineer antibodies with more complex functions and better biophysical properties. This approach reduces the difficulty of designing antibodies and other therapeutic proteins to tackle conditions ranging from chronic illness to life-threatening disease, while also massively speeding up candidate discovery and validation.

The collaboration with Synaffix/Lonza is instrumental to advancing BigHat’s next-gen ADC program, which is at IND-enabling stage and is on track to be BigHat’s first clinical stage program. BigHat’s next-gen ADC was optimized on BigHat’s Milliner platform for maximum payload delivery to tumor cells and optimal drug-like-properties. The incorporation of Synaffix’s GlycoConnect, HydraSpace and toxSYN ADC technologies is intended to further improve the safety and efficacy of Big Hat’s next-gen ADC.

Peter van de Sande, Head of Synaffix, said: "The ADC space continues to develop and evolve, and our collaboration with BigHat exemplifies the continued strength and appeal of our best-in-class ADC technology. We are excited to be at the forefront of next-generation ADC R&D by joining forces with BigHat and its AI/ML-enabled antibody discovery and development platform, BigHat is the ideal partner for Synaffix to collaborate with. We look forward to supporting BigHat with every step in the ADC development and manufacturing process under the Lonza umbrella."

Jean-Christophe Hyvert, President, Biologics, Lonza, added: "We are pleased to announce this collaboration with BigHat for its next-gen ADC molecule, which shows how drug developers can benefit from a fully integrated suite of services across our Biologics division. The Lonza network has continued to adapt to the evolving ADC landscape, including the recent addition of a highly potent vial fill capability at our Stein (CH) facility. This dedicated ADC drug product capacity expansion completes our offer for comprehensive, end-to-end development and manufacturing services for ADCs, simplifying the path from DNA-to-IND and beyond for our customers."

Mark DePristo, CEO at BigHat Biosciences, commented: "BigHat is leveraging our AI-driven antibody design platform, Milliner, to develop advanced biologics that provide safer and more effective treatments for difficult-to-treat cancers. We are excited to combine Synaffix’s conjugation and linker-payload technologies with our custom-designed antibody to create a next-generation ADC for patients with high unmet medical need."

On November 5, 2024 Ichnos Glenmark Innovation (IGI), a global fully-integrated clinical-stage biotech company developing multispecifics in oncology reported that it will present first-time data from its Phase 1 study of ISB 2001 in an oral presentation at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in San Diego, CA (Press release, Ichnos Sciences, NOV 4, 2024, View Source;utm_medium=rss&utm_campaign=igi-announces-first-presentation-of-data-from-phase-1-study-of-the-trispecific-isb-2001-in-relapsed_refractory-multiple-myeloma-r-rmm-at-upcoming-ash-annual-meeting [SID1234647727]). ISB 2001 is IGI’s first-in-class trispecific antibody targeting BCMA and CD38 on myeloma cells and CD3 on T cells, currently investigated in relapsed/refractory multiple myeloma (r/r MM).

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"Although recent advancements have brought new therapeutic options to multiple myeloma patients, resistance mechanisms continue to limit their efficacy, necessitating multiple lines of treatment for many patients," said Lida Pacaud, M.D., Chief Medical Officer at IGI. "We are encouraged by the early data from our Phase 1 study of ISB 2001, which shows a remarkable response rate and demonstrates potential to address these challenges in heavily pretreated patients."

The oral presentation will detail results from the dose-escalation portion of the study. The abstract features data as of July 2024, including:

An overall response rate (ORR) of 75% (9/12) in efficacy-evaluable patients, including one (1) MRD negative stringent complete response (sCR)
A favorable safety and tolerability profile that showed no dose-limiting toxicities (DLTs), only one adverse event of special interest (AE) above Grade 2, and no treatment discontinuation.
The oral presentation at ASH (Free ASH Whitepaper) will be supplemented with additional data and analyses.

Presentation details:

ISB 2001 Oral Presentation: First results of a Phase 1, First-in-Human, Dose Escalation Study of ISB 2001, a BCMAxCD38xCD3 Targeting Trispecific Antibody in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)

Presenter: Hang Quach, M.B.B.S, Professor of Haematology, University of Melbourne and Director of Clinical Haematology and Clinical Haematology Research, St. Vincent’s Hospital Melbourne

Session Name: 654. Multiple Myeloma: Pharmacologic Therapies: Into the Future: New Drugs and Combinations in Multiple Myeloma

Date & Time: Monday, December 9, 2024, at 5:45 PM

Room: San Diego Convention Center, Hall B

ISB 1442 Poster Presentation: Dose Escalation of ISB 1442, a Novel CD38 Biparatopic x CD47 Bispecific Antibody, in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)

Presenter: Binod Dhakal, M.D., M.S., Associate Professor of Medicine, Medical College of Wisconsin, Division of Hematology

Session Name: 654. Multiple Myeloma: Pharmacologic Therapies: Poster II

Presentation Date & Time: Sunday, December 8, 2024, 6:00-8:00 PM

Room: San Diego Convention Center, Halls G-H

About ISB 2001

ISB 2001 is the first trispecific antibody that simultaneously targets BCMA and CD38 on MM cells and CD3 to engage T cells. This first-in-class multispecific was developed using our BEAT (Bispecific Engagement by Antibodies based on the TCR) technology to create a highly specific antibody therapeutic that increases binding to MM cells while minimizing off-target activity. ISB 2001 is currently in a multi-center Phase 1 clinical trial in r/r MM. For more information about the study, visit: View Source

About ISB 1442

ISB 1442 is a first in class biparatopic CD38 x CD47 bispecific antibody based on the BEAT antibody technology with the ability to induce synthetic immunity via multiple effector mechanisms. ISB 1442 is in a Phase 1/2 study to assess safety and efficacy in r/r MM. For more information about the study, visit: View Source

On November 04, 2024 CrossBridge Bio, a biotechnology company pioneering dual-payload antibody-drug conjugates (ADCs) as targeted cancer therapies, reported the closing of a $10 million seed financing led by TMC Venture Fund and CE-Ventures, the corporate venture capital platform of Crescent Enterprises, with participation from Portal Innovations, Alexandria Venture Investments, Linden Lake Labs, and several pre-seed investors (Press release, CrossBridge Bio, NOV 4, 2024, View Source [SID1234647682]).

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Based on breakthrough research from Dr. Kyoji Tsuchikama and Dr. Zhiqiang An of UTHealth Houston, CrossBridge Bio’s dual-payload ADC platform combines both established and novel antibodies with various payload mechanisms of action, to develop a suite of ADC programs designed to offer distinct molecular properties, pharmacological actions, including payload synergy, and safety profiles for a range of cancer indications. The seed capital will fund the development of the company’s lead program, CBB-120, a potential best-in-class TROP-2 dual-payload ADC for the treatment of solid tumors, and accelerate the expansion of its pipeline of novel ADC programs. Additionally, funds will be used to further derisk the company’s proprietary linker technology with dual-payload applications, a critical component of its ADC platform, to improve the safety and efficacy profiles of its current and future drug candidates.

"We are thrilled to have the support of such experienced investors who share our vision of bringing transformative cancer therapies to patients in need," said Michael Torres, Ph.D., CEO of CrossBridge Bio. "Our dual-payload ADC technology is designed to deliver synergistic therapeutic effects using highly stable linkers that ensure payload release only within the targeted cancer cells, thereby maximizing their therapeutic effectiveness while minimizing the liabilities associated with uptake in unintended tissues, as seen with many of today’s cancer treatments. With these funds, the seasoned team we have built at CrossBridge will advance CBB-120, the first development candidate in our portfolio, into preclinical non-GLP toxicology studies and lay the groundwork for its future clinical development."

As part of this financing, both William McKeon, President and CEO of the Texas Medical Center (TMC), and Damir Illich, Ph.D. Manager, Life Sciences of CE-Ventures, will join CrossBridge Bio’s board of directors, bringing extensive experience in healthcare and life sciences to support the company’s strategic growth.

"We are proud to back CrossBridge Bio in their mission to develop the next generation of cancer therapies," said Mr. McKeon. "Their dual-payload ADCs are designed to deliver targeted drug release within cancer cells with greater stability, precision, and control. These breakthrough advancements have the potential to change patients’ lives worldwide and we look forward to helping drive their development."

"CrossBridge Bio’s innovative platform and ambitious pipeline have positioned the company as a new leader in the ADC drug discovery and development arena," said Dr. Illich. "We are excited to support their efforts to translate their platform innovations into therapies that meaningfully impact patients’ lives, starting with CBB-120."