On March 31, 2020 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company"), a clinical-stage biotechnology company focused on patient-specific immunotherapies for the treatment of cancer and infectious diseases, reported an update on its corporate progress and reported financial results for the quarter and full year ended December 31, 2019 (Press release, BioNTech, MAR 31, 2020, View Source [SID1234556044]).
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"2019 was transformational for BioNTech with pipeline advancements, additional collaborations with leading life science companies, and the completion of our initial public offering," said Ugur Sahin, BioNTech’s CEO. "We have continued this strong momentum into 2020 against a challenging market backdrop. We are continuing to advance our oncology pipeline and, along with our partners Pfizer and Fosun Pharma, aim to dose the first patient with our COVID-19 vaccine candidate within weeks. We also continued our efforts to strengthen our cell therapy capabilities and global footprint with our planned acquisition of Neon Therapeutics in the U.S., and look forward to multiple new trial starts and data read-outs across our pipeline during the year."
COVID-19 Vaccine Program Update
In early March 2020 BioNTech announced details of its efforts to develop a potential vaccine to induce immunity and prevent COVID-19 infection. BioNTech is working to initiate clinical testing for BNT162, a potential first-in-class mRNA vaccine against COVID-19, in late April 2020.
As part of the program, BioNTech announced two strategic collaborations with large pharma companies to ensure global development of a vaccine candidate and global access to any approved vaccine. BioNTech and Pfizer signed a letter of intent regarding the co-development and distribution of a potential mRNA-based coronavirus vaccine aimed at preventing COVID-19 infection. The collaboration aims to accelerate the development of BNT162, building on the existing research and development partnership between Pfizer and BioNTech signed in 2018,
under which the companies have been working together to develop mRNA-based vaccines for prevention of influenza. The companies expect to utilize multiple research and development sites from both companies. Details of the agreement regarding financial terms and all activities related to the development, manufacturing and potential commercialization are expected to be finalized shortly.
BioNTech also announced a strategic alliance with Fosun Pharma to develop its COVID-19 vaccine in China. Under the terms of the agreement, the two companies will work together on the development of BNT162 in China, conducting clinical trials in China and leveraging Fosun Pharma’s extensive clinical development, regulatory, and commercial capabilities in the country. If approved, Fosun Pharma will commercialize the vaccine in China.
Under the terms of the agreement, Fosun Pharma agreed to make an equity investment of $50 million (€44 million) for 1,580,777 ordinary shares in BioNTech, subject to execution of share subscription documentation and approval from regulatory authorities in China.
Fourth Quarter 2019 and Subsequent Updates
In addition to its development efforts, as the global COVID-19 pandemic continues to evolve, BioNTech has continuously monitored the situation in regards to its operations and has put significant measures in place to protect supply chain, operations, employees and the execution of clinical trials. Given the dynamic global situation, BioNTech notes there will be impacts to certain clinical trial timelines, as noted below. BioNTech will continue to evaluate potential effects and will provide updates as appropriate.
Oncology
FixVac
BNT111 – Data from the ongoing Phase 1 trial in advanced melanoma remains on track for publication in late 1H 2020. Based on further regulatory discussions, the Company expects to initiate a Phase 2 trial with registrational potential for BNT111 in 2H 2020.
It was dosed in a Phase 1/2a study in patients with prostate cancer. Eligible patients for dose titration have metastatic castration-resistant prostate cancer and will be treated with BNT112 as a single agent. For the expansion phase, patients with mCRPC and newly diagnosed high-risk, localized prostate cancer (LPC) are eligible and will be treated with BNT112 alone or in combination.
BNT114 – Data update from a Phase 1 trial in triple negative breast cancer (TNBC) is now expected in 2H 2020. Data was previously expected to be presented at The Association for Cancer Immunotherapy (CIMT) (Free CIMT Whitepaper) Annual Meeting in May 2020. Given the postponement of the conference, BioNTech is evaluating the appropriate opportunity to present the data.
BNT116 – The product candidate has been added to the FixVac portfolio and is currently in preclinical development for non-small cell lung cancer (NSCLC).
Individualized neoantigen specific immunotherapy (iNeST)
BNT121 – At the J.P. Morgan Health Care Conference in January 2020, BioNTech provided updated data from a Phase 1 trial for BNT121, the precursor to RO7198457 (BNT122), our lead iNeST product candidate. The data showed stable disease up to 60 months post vaccination in a cohort of eight advanced melanoma patients who were followed for relapse-free disease control following vaccination with iNeST.
BNT122 – BioNTech and Genentech disclosed that two additional Phase 2 clinical trials in the adjuvant setting are planned for initiation in 2020. The first adjuvant Phase 2 study will evaluate the efficacy, safety, pharmacokinetics, immunogenicity and biomarkers of RO7198457 plus atezolizumab compared with atezolizumab alone in patients with Stage 2-3 non-small cell lung cancer (NSCLC) who are circulating tumor DNA (ctDNA) positive following surgical resection and have received standard-of-care adjuvant platinum-doublet chemotherapy.
BNT122 – Following changes to the timing of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting due to the COVID-19 pandemic, we now expect the data update for the Phase 1/2 trial in multiple solid tumors to be presented in August 2020. BioNTech expects to provide an enrollment update1 from the Phase 2 trial in first line melanoma in 2H 2020 with an interim data update anticipated in 2021.
mRNA intratumoral immunotherapy
BNT131 – Data update from Phase 1/2 trial in solid tumors remains on track for 2H 2020.
Next-generation checkpoint immunomodulators
BNT311 – BioNTech now expects to provide a data update from the Phase 1/2 trial in multiple solid tumors (PD-L1x4-1BB) in 2H 2020, ahead of our previous 1H 2021 expectations.
Targeted cancer antibodies
BNT321 (MVT-5873) – Dosing has begun in the resumed Phase 1 study, evaluating the safety, maximum tolerated dose and recommended Phase 2 dose of BNT321 as a single agent in patients with pancreatic and other CA19-9 positive malignancies.
CAR-T cell immunotherapy
BNT211 – Initiation of a Phase 1/2a trial in multiple solid tumors (CLDN6) remains on track for 1H 2020.
We expect this data update to include an update on the ongoing study, including patient enrollment numbers, with full efficacy and safety data for an interim update expected in the second half of 2021.
Publication in Science on the Company’s novel CAR-T therapeutic approach for solid tumors which utilizes a CAR-T Cell Amplifying RNA Vaccine, or CARVac. The report entitled "An RNA vaccine drives expansion and efficacy of claudin-CAR-T cells against solid tumors" provides preclinical proof-of-concept data for BioNTech’s first CAR-T product candidate BNT211.
Trial initiations for the following programs have been delayed as a result of the COVID-19 pandemic.
Toll-Like Receptor Binding
BNT411 – U.S. IND was approved in Q4 2019. A Phase 1/2a clinical trial of BNT411 is now expected to be initiated as a mono- or combination therapy in multiple solid tumors in 2H 2020.
Ribomabs
BNT141 – Initiation of a Phase 1 trial in multiple solid tumors is now expected in 1H 2021.
BNT142 – Initiation of a Phase 1 trial in multiple solid tumors (CD3+CLDN6) is now expected in 1H 2021.
RiboCytokines
BNT151 – Initiation of a Phase 1 trial in multiple solid tumors (optimized IL-2) is now expected in 1H 2021.
BNT152+153 – Initiation of a Phase 1 trial in multiple solid tumors is now expected in 1H 2021.
Rare Diseases
BNT171 – Initiation of a Phase 1 trial in undisclosed indication is now expected in 1H 2021.
Infectious Diseases
BNT162 – Initiation of clinical testing for COVID-19 vaccine is expected in April 2020.
BNT161 – Initiation of clinical testing for a vaccine against influenza is now expected in 1H 2021.
Corporate Development
BioNTech and Neon Therapeutics, Inc. (Nasdaq: NTGN) announced that they have entered into a definitive merger agreement under which BioNTech will acquire Neon in an all-stock transaction. Neon is a biotechnology company developing novel neoantigen-based T cell therapies and has
deep expertise in the development of neoantigen therapies, with both vaccine and T-cell capabilities. At closing, BioNTech will issue, and Neon shareholders will receive, 0.063 American Depositary Shares (ADS) (each ADS representing one ordinary share of BioNTech) in exchange for each of their shares of Neon’s common stock. The transaction is expected to close during the second quarter of 2020.
Operations
In response to the COVID-19 outbreak, we are continuing to assess our supply chain and operations, which includes mRNA manufacturing for FixVac and iNeST platform products, as well as our CAR-T manufacturing operations. Our manufacturing operations are currently unaffected, but we will continue to monitor the potential impact as the pandemic develops.
In terms of our personnel, we have instituted a range of precautionary measures to ensure their continued safety. We are closely monitoring any employee that has potentially been in any contact with affected individuals or in affected areas and limiting access to BioNTech facilities as appropriate.
Full Year 2019 Financial Results
Cash Position: Cash and cash equivalents as of December 31, 2019, were €519.1 million.
Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was €28.0 million for the quarter ended December 31, 2019, compared to €63.8 million for the quarter ended December 31, 2018. The decrease was primarily due to decreased revenues from our collaboration with Sanofi. Total revenue, consisting primarily of revenue from collaborative agreements, was €108.6 million for the year ended December 31, 2019, compared to €127.6 million for the year ended December 31, 2018. The decrease was primarily due to decreased revenues from our collaboration with Sanofi. The decrease in revenue from Sanofi is primarily driven by a revenue of €33.2 million for a one-time reimbursement of certain sublicense costs that was fully recognized in the year ended December 31, 2018.
Research and Development Expenses: Research and development expenses were €65.4 million for the quarter ended December 31, 2019, compared to €51.8 million for the quarter ended December 31, 2018. The increase was primarily due to an increase in headcount and higher expenses incurred in our collaboration and own clinical projects. Research and development expenses were €226.5 million for the year ended December 31, 2019, compared to €143.0 million for the year ended December 31, 2018. The increase was primarily due to an increase in headcount, the full year impact of our ESOP program and higher spending for purchased services and laboratory supplies for our collaboration and own projects.
General and Administrative Expenses: General and administrative expenses were €11.1 million for the quarter ended December 31, 2019, compared to €10.1 million for the quarter ended December 31, 2018. General and administrative expenses were €45.5 million for the year ended December 31, 2019, compared to €26.3 million for the year ended December 31, 2018. The increase was primarily due to an increase in headcount and the full year impact of our ESOP program.
Net Loss: Net loss was €58.2 million for the quarter ended December 31, 2019, compared to net loss of €1.5 million for the quarter ended December 31, 2018. Net loss was €179.2 million for the year ended December 31, 2019, compared to net loss of €48.3 million for the year ended December 31, 2018.
Shares Outstanding: Shares outstanding as of December 31, 2019 were 226,779,744.
Full financial statements can be found in the 20-F filing as published on the SEC website under View Source
Conference Call and Webcast Information
BioNTech SE will host a conference call and webcast today at 08:00 a.m. ET (2:00 p.m. CET) to report its financial results for the full year ended December 31, 2019 and provide a corporate update.
To participate in the conference call, please dial the following numbers 15-20 minutes prior to the start of the call and provide the Conference ID: 1957628.
United States international: +1 631 510 7495
United States domestic (toll-free): +1 866 966 1396
Germany: +49 692 443 7351
Participants may also access the slides and the webcast of the conference call via the "Events & Presentations" page of the Investor Relations section of the Company’s website at View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.