March 31, 2020 Fourth Quarter and Full Year 2019 Corporate update and financial results March 31, 2020 Filed by BioNTech SE pursuant to Rule 425 under the Securities Act of 1933, as amended Subject Company: Neon Therapeutics, Inc. Commission File Number: 001
Important Additional Information and Where to Find It In connection with the proposed merger, BioNTech will file with the Securities and Exchange Commission (the “SEC”) a Registration Statement on Form F - 4 containing a proxy statement of Neon and a prospectus of BioNTech , and each of Neon and BioNTech may file with the SEC other documents regarding the proposed merger. The definitive proxy statement will be mailed to stockholders of Neon. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE REGISTRATION STATEMENT ON FORM F - 4 AND THE PROXY STATEMENT/PROSPECTUS, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THOSE DOCUMENTS AND ANY OTHER RELEVANT DOCUMENTS TO BE FILED WITH THE SEC IN CONNECTION WITH THE PROPOSED MERGER, WHEN THEY BECOME AVAILABLE, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT BIONTECH , NEON AND THE PROPOSED MERGER. Investors and security holders may obtain copies of these documents free of charge through the website maintained by the SEC at www.sec.gov or from BioNTech at its website, https://biontech.de, or from Neon at its website, https://Neon.com. Documents filed with the SEC by BioNTech will be available free of charge by accessing BioNTech’s website under the heading Investors & Media, or, alternatively, by directing a request by telephone or mail to BioNTech at An der Goldgrube 12, 55131 Mainz, Germany, and documents filed with the SEC by Neon will be available free of charge by accessing Neon’s website at https://neontherapeutics.com under the heading Invest or Resources or, alternatively, by directing a request by telephone or mail to Neon at 40 Erie Street, Suite 110, Cambridge, MA 021 39.
No Offer or Solicitation This presentation does not constitute an offer to sell or the solicitation of an offer to buy any securities nor a solicitation of any vote or approval with respect to the proposed transaction or otherwise. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the U.S. Securities Act of 1933, as amended, and otherwise in accordance with applicable law. Participants in Solicitation BioNTech and Neon and certain of their respective directors and executive officers and other members of management and employees may be deemed to be participants in the solicitation of proxies from the stockholders of Neon in respect of the proposed merger under the rules of the SEC. Information about Neon’s directors and executive officers is available in Neon’s definitive proxy statement dated April 26, 2019 for its 2019 Annual Meeting of Stockholders and certain of its Current Reports on Form 8-K. Information about BioNTech’s directors and executive officers is available in BioNTech’s Annual Report on Form 20-F filed with the SEC on March 31, 2020. Other information regarding the participants in the proxy solicitation and a description of their direct and indirect interests, by security holdings or otherwise, will be contained in the proxy statement/prospectus and other relevant materials to be filed with the SEC regarding the proposed merger when they become available. Investors should read the proxy statement/prospectus carefully when it becomes available before making any voting or investment decisions. You may obtain free copies of these documents from Neon or BioNTech using the sources indicated above.
Forward - looking statements Various statements in this slide presentation concerning the future expectations of BioNTech, its plans and prospects, including the Company’s views with respect to the potential for mRNA therapeutics ; the planned next steps in BioNTech’s pipeline programs and specifically including, but not limited to, statements regarding plans to initiate clinical trials of BioNTech’s BNT 111 , iNeST (BNT122), BNT141 , BNT142, BNT151, BNT152/153, BNT162, BNT211 and BNT 411 ; expectations for data announcements with respect to BioNTech’s BNT111 , BNT114 , iNeST (BNT122), BNT131 and BNT311 clinical trials; the development of commercial capabilities and the transition of BioNTech to a fully integrated biopharmaceutical company ; its expectations with respect to interactions with regulatory authorities such as FDA and EMA, including the potential approval of BioNTech’s or its collaborators’ current or future drug candidates ; expected royalty and milestone payments in connection with BioNTech’s collaborations ; BioNTech’s anticipated cash usage for fiscal year 2020 , the expected impact of the proposed merger with Neon Therapeutics on BioNTech’s business ; the timing of the closing of the proposed merger with Neon ; the creation of long - term value for BioNTech shareholders ; potential synergies between BioNTech and Neon and their pipelines ; and the ability of BioNTech to successfully develop and commercialize a vaccine for COVID - 19 in partnership with Pfizer and Fosun Pharma, constitute forward - looking statements . Words such as "expects," "plans," "potential," "target," "continue" and variations of these words or similar expressions are intended to identify forward - looking statements . Such statements are based on the current beliefs and assumptions of the management team of BioNTech and on the information currently available to the management team of BioNTech, and are subject to change . The Company will not necessarily inform you of such changes . These forward looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors that could cause the Company’s actual results, performance or achievements to be materially different than any future results, performance or achievements expressed or implied by the forward - looking statements . Actual results may differ materially from those indicated by these forward - looking statements as a result of various important factors, including the Company’s ability to discover and develop its novel product candidates, successfully demonstrate the efficacy and safety of its product candidates, the pre - clinical and clinical results for its product candidates, which may not support further development of product candidates ; actions of collaborators regarding continued product development and product commercialization ; actions of regulatory authorities, which may affect the initiation, timing and progress of clinical trials or the ability of the Company to obtain marketing authorization for its product candidates ; the Company’s ability to obtain, maintain and protect intellectual property, the Company’s ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties ; competition from others using technology similar to the Company’s and others developing products for similar uses ; the Company’s ability to manage operating expenses ; the Company’s ability to obtain additional funding to support its business activities and establish and maintain its existing and future collaborations and new business initiatives ; the Company’s dependence on collaborators and other third parties for development, manufacture, marketing, sales and distribution of products ; the outcome of litigation, and unexpected expenditures . Any forward - looking statements represent the Company’s views only as of today and should not be relied upon as representing its views as of any subsequent date . The Company explicitly disclaims any obligation to update any forward - looking statements . The mRNA vaccines and other product candidates discussed in this slide presentation are investigational products being developed by BioNTech and its collaborators and are not currently approved by the FDA, EMA or any other regulatory authority .
Next generation immunotherapy Harnessing the full potential of the immune system Industry - leading global collaborations Broad suite of novel technology platforms Immunotherapies for cancer and infectious diseases Fully integrated w/in - house GMP manufacturing
Strong momentum heading into remainder of 2020 2019 and 1Q 2020 Highlights Increased clinical stage pipeline from 7 to 10 product candidates since IPO Additional pharma partnerships including expansion of Pfizer collaboration and Fosun Pharma Announced acquistion of Neon Therapeutics Successful Series B and IPO financings raising $374m in total gross proceeds Expansion of mRNA and Cell Therapy manufacturing capacity on track for 2020 completion
Rapid progress for COVID - 19 vaccine program with global consortium C:\Users\jwoolford\AppData\Local\Microsoft\Windows\INetCache\Content.MSO\92D90558.tmp • “Light - speed” program includes both vaccines and therapeutics • BNT162: mRNA - based vaccine aimed at preventing COVID - 19 infection • Exploits highly potent Lipid - Nano - Particulate (LNP) mRNA vaccine platforms for the prevention of infectious diseases • Preclinical activity demonstrated in multiple infectious disease models including Influenza, Ebola Virus, Zika Virus, HIV and others • To be manufactured at state - of - the - art GMP certified mRNA manufacturing facilities in Europe • Initiation of clinical testing expected late April 2020 C:\Users\jwoolford\AppData\Local\Microsoft\Windows\INetCache\Content.MSO\DC6CA0DD.tmp • Letter of intent signed for co - development and distribution outside of China • R&D sites from both companies • Builds on previous R&D collaboration for mRNA - based vaccines for influenza • Joint development in China and collaboration to conduct trials in China • BNTX to receive up to $ 135m in upfront, investment and milestones • Companies to share gross profits from sales in China
Neon Therapeutics: Acquisition strengthens T cell therapy leadership • Expands BioNTech’s growing CAR - T and TCR therapy pipeline • Provides deep expertise in development of neoantigen therapies • Pipeline of adoptive T cell and neoantigen TCR therapies • NEO - PTC - 01: personalized neoantigen - targeted T cell therapy consisting of multiple T cell populations that target most therapeutically relevant neoantigen from each patient’s tumor • NEO - STC - 01: T cell therapy candidate targeting shared RAS neoantigens • Libraries of high - quality TCRs against various shared neoantigens across common HLAs • Accelerates global expansion by creating U.S. R&D hub • All - stock transaction valued at $67m at announcement • Transaction expected to close in 2Q 2020
Intend to initiate Phase 2 trials for BNT111, BNT113 and BNT 122 ( iNeST , adjuvant ) as planned • Regulatory and trial start - up activities continuing • End of year 2020 anticipated start dates provide time for stabilization of clinical trial environment • Managing ongoing Phase 1 exploratory/dose escalation trials to support timely completion • Evidence of slowed enrollment given restrictions at clinical sites and travel restrictions for patients • BNT111 and BNT114 less affected given near completion of enrollment • Optimizing ability to initiate and conduct FIH studies • Maintaining timing guidance for initiation of FIH trial for CARVac (BNT211) program • Expected delays for several other trial starts of approximately 3 - 6 months BNT141 and BNT142 ( RiboMabs ), BNT 151 and BNT152/153 ( RiboCytokines ), BNT161 (Influenza), BNT171 (Rare Disease) and BNT411 (TLR7) Update on estimated COVID - 19 impact on ongoing / planned clinical trials As COVID - 19 situation remains dynamic, BioNTech will continue to monitor the situation and provide further updates if necessary
Key clinical stage pipeline updates Drug class Platform Product Candidate Indication (Targets) Oncology mRNA FixVac (fixed combination of shared cancer antigens) BNT111 advanced melanoma (adjuvant & metastatic) BNT112 prostate cancer BNT113 HPV16+ head and neck cancer 1 BNT114 triple negative breast cancer BNT115 ovarian cancer 1 iNeST (patient specific cancer antigen therapy) RO7198457 (BNT122 3 ) 1L melanoma with CPI 2,6 multiple solid tumors NSCLC (adjuvant) undisclosed (adjuvant) Intratumoral Immunotherapy SAR441000 (BNT131) solid tumors (IL - 12sc, IL - 15sushi, GM - CSF, IFN a ) Antibodies Next - Gen CP 5 Immunomodulators GEN1046 (BNT311) multiple solid tumors (PD - L1 ×4 - 1BB) GEN1042 (BNT312) multiple solid tumors (CD40 ×4 - 1BB) Targeted Cancer Antibodies BNT321 (MVT - 5873) pancreatic cancer (sLea) 1 BNT113 and BNT115 are currently being studied in investigator - initiated phase 1 trials; 2 Checkpoint Inhibitor; 3 BNT122 (iNeST) is also being investigated in arm 2 (N=15) of the 3 arm TNBC - MERIT trial, with BNT114 as an optional treatment; BNT114 is investigated in arm 1 (N=12) and arm 3 (N=15) of the TNBC - MERIT trial (total patients in study: N=42 ; 5 Checkpoint; 6 We expect data update to include an update on the ongoing study, including patient enrollment numbers, with full efficacy and safety data fo r a n interim update expected in the second half of 2021. BNT111: Phase 2 with registrational potential expected to start in 2H 2020 BNT122 ( iNeST ): Two adjuvant studies to start in 2H 2020 BNT114: Data update now expected in 2H 2020 BNT311: Data update now expected in 2H2020 BNT113: Phase 2 with registrational potential expected to start in 2H 2020 BNT321: First patient dosed in Phase 1/2 study BNT122 ( iNeST ): Data update now expected to be released in August 2020; interim data for Phase 2 melanoma trial still expected in 2H 2021
Key pre - clinical stage pipeline updates Drug class Platform Product Candidate Indication (Targets) Oncology mRNA FixVac BNT116 NSCLC RiboMabs (mRNA - encoded antibodies) BNT141 multiple solid tumors BNT142 multiple solid tumors (CD3+CLDN6) RiboCytokines (mRNA - encoded Cytokines) BNT151 multiple solid tumors (optimized IL - 2) BNT152+ BNT153 multiple solid tumors (IL - 7, IL - 2) Engineered Cell Therapies CAR - T Cells BNT211 multiple solid tumors ( CLDN6) BNT212 pancreatic, other cancers (CLDN18.2) TCRs u ndisclosed undisclosed To be selected all tumors SMIM 1 Toll - Like Receptor Binding BNT411 solid tumors (TLR7) 1 Small Molecule Immunomodulators; 2 Protein Replacement Therapy mRNA Infectious Disease Immunotherapies BNT161 Influenza BNT162 COVID - 19 u ndisclosed up to 10 indications u ndisclosed HIV and tuberculosis Rare Disease PRT 2 BNT171 undisclosed u ndisclosed 4 additional rare disease indications BNT116: Added to preclinical portfolio BNT211: Phase 1/2 initiation on track for 1H 2020 BNT411: US IND approved; Phase 1 initiation for 2H 2020 BNT162: Clinical trial initiation expected in April 2020 (NEW PROGRAM)
BNT111 and BNT122 Phase 2 trial updates BNT111 ( Fixvac ) • Phase 1 data publication expected late 1H 2020 • Registrational trial in melanoma on track to initiate in late 2H 2020 • Phase 2 with registrational potential • Arms to include BNT111 in combination with CPI and control arms • Study population includes patients progressing at baseline on CPI • Additional details expected in 3Q 2020 BNT122 ( iNeST ) • In line with delay of AACR conference due to COVID - 19 pandemic, data update expected in August
Fourth Quarter 2019 (unaudited) and FY 2020 (audited) Financial Results Total Business Profit & Loss 1 Three months ended December 31, Twelve months ended December 10, In EURm 2019 2018 2019 2018 Collaboration revenue 20.2 56.4 84.4 101.8 Revenue from other sales transactions 7.8 7.4 24.2 25.7 Total Revenue 28.0 63.8 108.6 127.6 Cost of sales (4.4) (4.5) (17.4) (13.7) Gross profit 23.6 59.3 91.2 113.9 Research and development expenses (65.4) (51.8) (226.5) (143.0) Sales and marketing expenses (0.8) (1.1) (2.7) (3.0) General and administrative expenses (11.1) (10.1) (45.5) (26.3) Other operating / financial income less expenses (4.8) 2.2 4.1 10.9 Income taxes 0.3 0 0.3 (0.6) Loss for the period (58.2) (1.5) (179.2) (48.3) • Cash and cash equivalents of EUR 519m as of December 31, 2019 • Net cash used in operating activities expected to total approximately EUR 300 for FY 2020 1 We have made rounding adjustments; accordingly, numerical figures shown as totals may not be exact aggregations of the figure s that preceded them
Titelmasterformat durch Klicken bearbeiten Building a Next G eneration I mmunotherapy c ompany 2020 Outlook . 6 trial updates (incl. publishing BNT111 FixVac Melanoma phase 1 data in peer reviewed journal) . Initiate registrational trial for BNT111 FixVac Melanoma . Initiate 2 additional iNeST trials in adjuvant stage cancers . Initiate clinical testing of BNT 162 COVID19 vaccine by late April 2020 . Initiate phase 1/2 trial using CARVac (BNT211) in CLDN6+ solid tumors . Initiate phase 1 trial for TLR7 program (BNT411) in solid tumors . Integrate US Hub in Cambridge post closing of Neon acquisition in 2Q 2020 1 2 3 4 5 6 7