BridgeBio Pharma, Inc 8-K, filed Sep 29, 2020
BridgeBio Pharma, Inc. (BBIO)
About this 8-K
BridgeBio Pharma, Inc filed this 8-K on September 29, 2020.
Items reported
- Item 7.01: Regulation FD disclosure
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): September 29, 2020
BridgeBio Pharma, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-38959 | 84-1850815 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
| 421 Kipling Street Palo Alto, CA |
94301 | |
| (Address of principal executive offices) | (Zip Code) |
(650) 391-9740
(Registrant’s telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered | ||
| Common stock | BBIO | The Nasdaq Global Select Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 7.01. | Regulation FD Disclosure. |
On September 29, 2020, BridgeBio Pharma, Inc. will present at its Research and Development Day. The slide presentation to be presented at the Research and Development Day is furnished as Exhibit 99.1 to this Form 8-K and is incorporated by reference herein.
The information responsive to Item 7.01 of the Form 8-K, including Exhibit 99.1 attached hereto, is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit Number |
Description | |
| 99.1 | Presentation of BridgeBio Pharma, Inc., dated September 29, 2020 | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| BridgeBio Pharma, Inc. | ||||||
| Date: September 29, 2020 | /s/ Brian C. Stephenson | |||||
| Brian C. Stephenson | ||||||
| Chief Financial Officer | ||||||
R&D Day September 29, 2020 Exhibit 99.1
Forward-Looking Statements and Disclaimer Statements in this Presentation that are not statements of historical fact are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such forward-looking statements include, without limitation, statements regarding BridgeBio Pharma, Inc.’s (the “Company’s”) research and clinical development plans, expected manufacturing capabilities, strategy, regulatory matters, market size and opportunity, future financial position, future revenue, projected costs, prospects, plans, objectives of management, and the Company’s ability to complete certain milestones. Words such as “believe,” “anticipate,” “plan,” “expect,” “intend,” “will,” “may,” “goal,” “potential,” “should,” “could,” “aim,” “estimate,” “predict,” “continue” and similar expressions or the negative of these terms or other comparable terminology are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. These forward-looking statements are neither forecasts, promises nor guarantees, and are based on the beliefs of the Company's management as well as assumptions made by and information currently available to the Company. Such statements reflect the current views of the Company with respect to future events and are subject to known and unknown risks, including business, regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about the Company, including, without limitation, risks inherent in developing therapeutic products, the success, cost, and timing of the Company’s product candidate development activities and ongoing and planned preclinical studies and clinical trials, , trends in the industry, the legal and regulatory framework for the industry, the Company’s ability to obtain and maintain regulatory approval for its product candidates, the Company’s ability to commercialize its product candidates, future agreements with third parties in connection with the development or commercialization of the Company’s product candidates, the size and growth potential of the market for the Company’s product candidates, the accuracy of the Company’s estimates regarding expenses, future revenue, future expenditures and needs for and ability to obtain additional financing, the Company’s ability to obtain and maintain intellectual property protection for its product candidates, potential adverse impacts due to the global COVID-19 pandemic such as delays in clinical trials, preclinical work, overall operations, regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy, and those risks and uncertainties described under the heading “Risk Factors” in the Company’s most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (“SEC”) and in subsequent filings made by the Company with the SEC, which are available on the SEC’s website at www.sec.gov. In light of these risks and uncertainties, many of which are beyond the Company’s control, the events or circumstances referred to in the forward-looking statements, expressly or implicitly, may not occur. The actual results may vary from the anticipated results and the variations may be material. You are cautioned not to place undue reliance on these forward-looking statements, which speak the Company’s current beliefs and expectations only as of the date this Presentation is given. Except as required by law, the Company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this Presentation in the event of new information, future developments or otherwise. No representation is made as to the safety or effectiveness of these product candidates for the therapeutic use for which such product candidates are being studied. Certain information contained in this Presentation relates to or is based on studies, publications, surveys and other data obtained from third-party sources and the Company’s own internal estimates and research. While the Company believes these third-party sources to be reliable as of the date of this Presentation, it has not independently verified, and makes no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. In addition, all of the market data included in this Presentation involves a number of assumptions and limitations, and there can be no guarantee as to the accuracy or reliability of such assumptions. Finally, while the Company believes its own internal research is reliable, such research has not been verified by any independent source. The Company is the owner of various trademarks, trade names and service marks. Certain other trademarks, trade names and service marks appearing in this Presentation are the property of third parties. Solely for convenience, the trademarks and trade names in this Presentation are referred to without the ® and TM symbols, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto.
BridgeBio Pharma: Hope through rigorous science Our mission: To discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers
BridgeBio corporate overview Strategy Platform Products
Source: Claussnitzer et al., Nature 2020 Draft human genome High-throughput sequencing UKBiobank recruitment begins GWAS results catalogue initiated ClinVar launches >1 million GWAS samples Hundreds of monogenic disease-causing variants are discovered every year… …and common disease associations are increasing exponentially Genes that cause monogenic diseases Common disease GWAS associations We are at Day 1 in the era of genetic medicine
~ > US prevalence, mn Americans are living with a genetic diseases Of people affected are children Of these diseases have an approved therapy 57% of cancers have genetic drivers A vast opportunity to help patients ~27 million 50% Only 5% Source: Global Genes, American Cancer Society, American Heart Association, Alzheimer’s Association, Arthritis Foundation, Bailey et al., Cell 2018
Our strategy is simple Right playing field Genetic disease History teaches us about strategy: BBIO applications: Stay adaptive Beautiful science, NPV positive Right tenets No initial focus on TA, disease, or modality. Repeated application
Our organizational principles enable scale Simple rules repeated at many levels Simple rules – put patients first, think independently and let science speak, be efficient History teaches us about growth: BBIO applications: De-centralized approach – small teams that focus and are incented at the level of each asset, scale that allows for rapid failure, learning De-centralized cities grow with returns to scale, centralized companies slow with economies of scale
Result: Pipeline momentum 20+ programs Multiple $1B+ opportunities in Ph3 Two NDA submissions >10 INDs in 5 years BridgeBio founded 1 pipeline program 10 pipeline programs 3 clinical compounds 20 10 1
Increasing returns to scale – BridgeBio since IPO 7 INDs filed Six new clinical trials initiated (16 total), >350 trial sites across 25 countries NDA for MoCD Type A accepted, ODD & Fast Track received for 2L CCA program 8 new programs, including LGMD2i and ADH1, both in the clinic Achievement: TTR clinical data, DEB clinical data, CAH and Canavan pre-clinical data, achon pre-clinical data, TIO data
BridgeBio corporate overview Strategy Platform Products
Well described diseases than can be targeted at their source Tailored therapeutic technologies to create first or best-in-class medicines Broad clinical development capabilities across therapeutic areas and geographies Building the capabilities to deliver genetic medicines to patients globally Discover Novel genetic disease targets Create Medicines with industry-leading research capabilities Test Our drugs through global development footprint Deliver Our products to patients through commercial infrastructure BridgeBio drug engineering basics: our platform
Mining of large genotype-phenotype databases De novo target discovery Target validation Indication expansion Manual annotation and prioritization of the 7K known genetic diseases 15 current partnerships Our target identification engine is driven by three core areas of strength: Computational genomics / statistical genetics Systematic disease mapping Partnering with top academic researchers Capabilities to identify new genetic disease targets at scale Discover
Scientific insight and judgment from industry leaders with a proven track record Richard Scheller, PhD Chairman of R&D Charles Homcy, MD Founder and Chairman of Pharmaceuticals Frank McCormick, PhD Founder and Chairman of Oncology Len Post, PhD Advisor Phil Reilly, MD, JD Advisor Discover
Industry-leading capabilities across 4 modalities: Medicinal chemistry Gene therapy Molecular dynamics Reversible and irreversible chemistry Topical formulations Vector optimization Novel capsid engineering Analytical assay development Optimal use: Inhibition of GOF or allosteric activation of LOF mutations Optimal use: Replacement of intracellular protein in LOF diseases Therapeutic proteins Antisense oligonucleotides Large protein manufacturing Formulation expertise Comparability assay development Target mapping with functional genomics Activity screening assay development Novel backbone and base chemistry Optimal use: Replacement of extracellular protein in LOF diseases Optimal use: Inhibition of GOF or activation of WT allele in LOF diseases We select the optimal therapeutic modality to target each disease at its source Create GOF = gain-of-function, LOF = loss-of-function, WT = wild type
Mendelian Oncology Gene therapy Research leaders with a productive history developing novel therapeutics Create Uma Sinha, PhD Chief Scientific Officer Robert Zamboni, PhD Chemistry Eli Wallace, PhD Chief Scientific Officer, Oncology Pedro Beltran, PhD SVP, Biology Clayton Beard, PhD SVP, Research and Development
16 ongoing trials across 5 different therapeutic areas, >350 trial sites, and 25 countries Creative clinical and regulatory strategy, e.g., unique, nested Phase 3 trial design for acoramadis in ATTR Central operations toolkit for enrollment, protocol quality, site activation, CRO quality, regional performance Expert, dedicated R&D teams in each therapeutic area Cardio/renal: Jonathan Fox, MD, PhD Oncology: Susan Moran, MD Gene Therapy: Adam Shaywitz, MD, PhD Countries with BridgeBio trial sites Our global clinical development footprint Test
Global commercial infrastructure to leverage our drug and disease expertise Diagnostic partnerships to identify patients in need of our medicines Disease awareness strategies including close partnerships with patient advocacy groups Country-specific Early Access Programs (EAP) and patient assistance programs Commercial partners in strategic geographies: FGFRi and SHP2i in China: TTR in Japan: Matt Outten (CCO), Jennifer Cook (BOD), Brent Saunders (BOD) Key people: Building capabilities to deliver our products to patients across the globe Deliver MoCD type A in Israel:
Discover Novel genetic disease targets Create Medicines with industry-leading research capabilities Deliver Our products to patients through commercial infrastructure Test Our drugs through global development footprint 20+ Disclosed programs in the pipeline >10 INDs since 2015 16 Clinical trials across the globe 2 Product launches expected in 2021 The platform is delivering
BridgeBio corporate overview Strategy Platform Products
Portfolio segment Program Drug mechanism Diseases Patient pop. (US+EU) Modality Preclinical Clinical Discovery IND-enabling Phase1 Phase 2 Phase 3 Mendelian Acoramidis TTR stabilizer ATTR-CM >400K Fosdenopterin cPMP replacement MoCD type A 100 Infigratinib Low-dose FGFR1-3i Achondroplasia 55K Encaleret CaSR antagonist ADH1 / HP 12K1 / 200K Zuretinol Synthetic retinoid IRD (RPE65 or LRAT) 3K BBP-418 Glycosylation substrate LGMD2i 7K BBP-711 GO1 inhibitor PH1 / FSF 5K / 1.5M BBP-671 PanK activator PKAN / OA 7K BBP-761 Succinate prodrug LHON 20K BBP-472 PI3Kβi PTEN autism 120K Genetic Dermatology Patidegib2 Topical SMOi Gorlin / BCC 120K BBP-589 Recombinant COL7 RDEB 1.5K BBP-681 Topical PI3Kai VM / LM 117K BBP-561 Topical KLK 5/7i Netherton 11K Targeted Oncology Infigratinib FGFR1-3i FGFR+ tumors 37K BBP-398 SHP2i Multiple tumors >500K BBP-454 Pan-mutant KRASi KRAS+ tumors >500K BBP-954 GPX4i Multiple tumors >500K Gene Therapy BBP-631 21-OH gene therapy CAH >75K BBP-812 ASPA gene therapy Canavan 1K BBP-815 TMC1 gene therapy Genetic hearing loss 10K 1 US carriers; 2 We are party to an option agreement pursuant to which LEO Pharma A/S has been granted an exclusive, irrevocable option to acquire PellePharm, including the BBP-009 program. If the option is exercised by LEO Pharma A/S, we will no longer have rights to develop and commercialize BBP-009. Our pipeline of 20+ development programs spans multiple therapeutic areas and drug modalities NDA filed Small molecule Biologics Gene therapy Topical small molecule
Low-dose infigratinib (FGFRi) for achondroplasia Enrolling Ph2 study Dose first child Phase 2 data 2021 ATTR-CM Ph3 ongoing GLP tox ongoing File IND Phase 1/2 data 2021 Ph2 ongoing FPI in Ph2 study Phase 2 data 2021 Acoramidis: TTR stabilizer for ATTR Gene therapy for congenital adrenal hyperplasia (BBP-631) Encaleret: CaSR inhibitor for autosomal dominant hypocalcemia type 1 (ADH1) Program Status Upcoming event(s) Opportunity size >400K 55K >75K 12K Topline Ph3 part A data late-2021 / early-2022 Topline Ph3 part B data 2023 Four core value drivers over the next 12-24 months
A pipeline with multi-blockbuster potential $1B+ opportunities in the pipeline Acoramidis for ATTR CM and PN Low-dose infigratinib for achondroplasia AAV5 gene therapy for congenital adrenal hyperplasia High-dose infigratinib for adjuvant urothelial carcinoma Pan-mutant KRAS inhibitor for KRAS+ cancer SHP2 inhibitor for RAS and kinase mutant cancer GPX4 inhibitor for multiple tumor types GO1 inhibitor for frequent kidney stone formers 8
Speaker Low-dose infigratinib (FGFRi) for achondroplasia Acoramidis: TTR stabilizer for ATTR cardiomyopathy Gene therapy for congenital adrenal hyperplasia (BBP-631) Encaleret: CaSR inhibitor for autosomal dominant hypocalcemia type 1 (ADH1) Oncology research, KRAS Related program Thank you to our speakers Ravi Saravirayan, MD, PhD Professor and Group Leader, Murdoch Children’s Research Institute Head of Clinical Genetics Services at the Victorian Clinical Genetic Services Julian Gillmore, MD, PhD Head, Centre for Amyloidosis & Acute Phase Proteins, University College London Kyriakie (Kiki) Sarafoglou, MD Associate Professor, University of Minnesota Medical School and College of Pharmacy Michael Collins, MD Chief of the Skeletal Disorders and Mineral Homeostasis Section, National Institutes of Health Frank McCormick, PhD BridgeBio Chairman of Oncology Professor, Helen Diller Family Comprehensive Cancer Center University of California San Francisco