BioCryst Reports Third Quarter 2024 Financial Results and Provides Business Update

On Nov. 04, 2024 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported financial results for the third quarter ended September 30, 2024, and provided a corporate update (Press release, BioCryst Pharmaceuticals, NOV 4, 2024, View Source [SID1234648574]).

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"Our third quarter performance continues to build on the outstanding year we are having, with significant revenue growth, strong patient demand, pipeline advancement and operating profitability in the quarter. As we look ahead, we see robust and durable revenue growth, new opportunities for younger children to benefit from ORLADEYO, and data readouts from BCX17725 in Netherton syndrome and avoralstat in DME, all while moving closer to sustainable profitability," said Jon Stonehouse, president and chief executive officer of BioCryst.

Program Updates

ORLADEYO (berotralstat): Oral, Once-daily Treatment for Prevention of Hereditary Angioedema (HAE) Attacks

"The real-world efficacy and convenience patients and physicians are experiencing with ORLADEYO are driving accelerated commercial momentum that translates to nearly 36 percent revenue growth in our fourth year on the market. Based on this established sales trajectory, and the continued, durable strength of patient demand we see for ORLADEYO, we are more confident than ever of achieving peak sales of $1 billion for ORLADEYO," said Charlie Gayer, chief commercial officer of BioCryst.

ORLADEYO net revenue in the third quarter of 2024 was $116.3 million (+35.7 percent year-over-year (y-o-y)).

Start forms in the U.S. are up 14.2 percent over the past 12 months compared to the prior 12 months; and 67 new U.S. prescribers were added during the third quarter, one of the highest totals over the most recent eight quarters.

The reimbursed product rate in the U.S. increased 0.4 percent in the third quarter to 74.8 percent.

Sales from outside the U.S. contributed 11.4 percent of global ORLADEYO net revenues in the third quarter.

Since launch, approximately half of patients who have started ORLADEYO have switched from another prophylactic therapy. The company has begun the observational Phase 4 APeX-T study, designed to generate real-world data to inform physicians on the best individual approaches to support transition to ORLADEYO.
Rare Disease Pipeline

"The goal with our pipeline is to build on our success with ORLADEYO by bringing the next highly differentiated product to patients living with rare disease. We are making excellent progress, with BCX17725 now in the clinic, avoralstat nearing the clinic and initial patient data from both programs expected next year. These programs would address significant unmet needs for patients with Netherton syndrome and DME, respectively," said Dr. Helen Thackray, chief research and development officer at BioCryst.

The company has advanced BCX17725, its KLK5 inhibitor for the treatment of Netherton syndrome, into clinical trials and expects initial data from the program in 2025.

Netherton syndrome is a serious, rare, lifelong genetic disorder affecting the skin, hair, and immune system, caused by lack of normal function of a natural inhibitor of KLK5. People with Netherton syndrome often have red, scaly, inflamed skin, fragile hair, and are more likely to develop skin infections, allergies, asthma and eczema. Netherton syndrome can be life threatening, especially during infancy when patients are vulnerable to dehydration and recurrent infections. Currently, there are no approved treatments for Netherton syndrome.

In 2025, the company plans to advance avoralstat, a plasma kallikrein inhibitor, into a clinical trial of patients with diabetic macular edema (DME).

DME is an important cause of vision loss in diabetes and is due to leakage from the blood vessels in the retina. While current treatments focus on VEGF inhibition, DME can develop from other mechanisms, such as the kallikrein-bradykinin pathway. This is supported by observations that many DME patients have an incomplete response to intravitreal anti-VEGF therapies that are administered every four to eight weeks. Avoralstat targets the kallikrein-bradykinin system on the retinal vascular endothelial cells and may result in less vascular leakage and less edema. Avoralstat, delivered to the suprachoroidal space as a depot formulation, is designed to provide high dose levels to the retinal vessels with long-lasting exposure, which could result in less frequent injections and a reduced burden on patients and the healthcare system.
Third Quarter 2024 Financial Results

"It is exciting to see continued ORLADEYO growth alongside the significant progress advancing our pipeline, and another quarter of operating profit. BioCryst is in the strongest financial position in its history," said Anthony Doyle, chief financial officer at BioCryst.

For the three months ended September 30, 2024, total revenues were $117.1 million, compared to $86.7 million in the third quarter of 2023 (+35.1 percent y-o-y). The increase was primarily due to $116.3 million in ORLADEYO net revenue in the third quarter of 2024, compared to $85.7 million in ORLADEYO net revenue in the third quarter of 2023 (+35.7 percent y-o-y).

Research and development expenses for the third quarter of 2024 decreased to $41.1 million from $46.9 million in the third quarter of 2023 (-12.4 percent y-o-y), primarily due to decreased investment following the discontinuation of the BCX10013 program, partially offset by investments to advance our early clinical and discovery programs and an increased investment in the APeX-P program in preparation for regulatory filings next year.

Selling, general and administrative expenses for the third quarter of 2024 increased to $65.1 million, compared to $50.6 million in the third quarter of 2023 (+28.7 percent y-o-y). The increase was primarily due to increased commercial investment to support our growing revenue, newly launched regions and expanded international operations. There was also an increase in general and administrative expenses to support commercial growth.

Interest expense was $24.8 million in the third quarter of 2024, compared to $27.3 million in the third quarter of 2023 (-9.2 percent y-o-y). The decrease was primarily due to a decrease in the amortization of interest associated with our royalty financing obligations. Due to the strong cash position of the company, we declined to elect the payment-in-kind (PIK) option related to the Pharmakon term loan for the third quarter of 2024, resulting in a cash interest payment of $10.2 million in the third quarter of 2024 compared to $4.9 million in the third quarter of 2023. The PIK option has now expired. Additionally, the company chose not to execute its option, which expired September 30, 2024, to draw the additional $150 million of debt available to it from Pharmakon.

GAAP operating profit for the third quarter of 2024 was $7.7 million, compared to a GAAP operating loss of $11.9 million for the third quarter of 2023. Non-GAAP operating profit, excluding stock-based compensation expense, was $24.9 million for the third quarter of 2024 compared to $0.4 million for the third quarter of 2023.

Net loss for the third quarter of 2024 was $14.0 million, or $0.07 per share, compared to a net loss of $36.1 million, or $0.19 per share, for the third quarter of 2023.

Cash, cash equivalents, restricted cash and investments totaled $351.7 million at September 30, 2024, compared to $399.2 million at September 30, 2023. Operating cash increased by $13.1 million in the third quarter of 2024.

Financial Outlook for 2024

Based on the strength of patient demand for ORLADEYO seen in the third quarter, and expected continued strength in the fourth quarter, the company is adjusting its outlook for full year 2024 global net ORLADEYO revenue to be between $430 million and $435 million (top end of prior range) and introducing full-year 2024 total revenue guidance of between $443 and $448 million based on additional 2024 RAPIVAB revenue.

Directly related to the revenue strength for both ORLADEYO and RAPIVAB, the company is revising its guidance for operating expenses, and now expects full year 2024 operating expenses to be between $380 million and $390 million. The increase is driven primarily by increased COGS related to new RAPIVAB sales, increased variable costs, including incentive compensation and distribution costs related to the continued strong revenue performance for ORLADEYO and increased expenses that are seasonally booked in Q4 related to our support for the HAE community, including charitable donations. This operating expense outlook does not reflect non-cash stock compensation expense, or one-time expenses related to the previously announced workforce reduction implemented in the first quarter of 2024.

Based on the company’s disciplined approach to capital allocation, and the strong performance of ORLADEYO, the company is confident that it will achieve a full-year operating profit in 2024 (not including non-cash stock compensation), be approaching quarterly positive earnings per share (EPS) and positive cash flow in the second half of 2025 (not including non-cash stock compensation) and be profitable on an EPS basis, with positive cash flow, for full year 2026. The company expects it can achieve these financial milestones without raising additional funds.

BioNTech Announces Third Quarter 2024 Financial Results and Corporate Update

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

BriaCell Overall Survival Data Selected for Spotlight Poster at 2024 San Antonio Breast Cancer Symposium®, December 10 – 13

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

Lonza’s Synaffix Collaborates with BigHat Biosciences on the Development of a Machine Learning-Designed ADC

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."

Ichnos Glenmark Innovation (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

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