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Progenity (PROG) Investor Presentation - Nov 30, 2021
- 2. FORWARD-LOOKING STATEMENTS This presentation contains “forward-looking statements” within the meaning of the federal securities laws, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this presentation, including statements concerning our plans, objectives, goals, strategies, future events, future revenues or performance, plans or intentions relating to product candidates, estimates of market size, estimates of market growth, business trends, the anticipated timing, design and conduct of our planned clinical trials, the development of our product candidates, including the timing and likelihood of regulatory filings and approvals for our product candidates, our ability to commercialize our product candidates, if approved, the pricing and reimbursement of our product candidates, if approved, the potential to develop future product candidates, the potential benefits of strategic collaborations and our intent to enter into any strategic arrangements, the timing and likelihood of success, plans and objectives of management for future operations and future results of anticipated product development efforts, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this presentation, including those described in “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2020, and elsewhere in such filing and in other subsequent disclosure documents, including our Quarterly Reports on Form 10-Q, filed with the U.S. Securities and Exchange Commission (SEC). We cannot assure you that we will realize the results, benefits or developments that we expect or anticipate or, even if substantially realized, that they will result in the consequences or affect us or our business in the way expected. Forward-looking statements are not historical facts and reflect our current views with respect to future events. Given the significant uncertainties, you should evaluate all forward-looking statements made in this presentation in the context of these risks and uncertainties and not place undue reliance on these forward-looking statements as predictions of future events. All forward-looking statements in this presentation apply only as of the date made and are expressly qualified in their entirety by the cautionary statements included in this presentation. We disclaim any intent to publicly update or revise any forward-looking statements to reflect subsequent events or circumstances, except as required by law. Industry and Market Data: We obtained the industry, market, and competitive position data used throughout this presentation from our own internal estimates and research, as well as from industry and general publications, and research, surveys, and studies conducted by third parties. Internal estimates are derived from publicly available information released by industry analysts and third-party sources, our internal research and our industry experience, and are based on assumptions made by us based on such data and our knowledge of the industry and market, which we believe to be reasonable. In addition, while we believe the industry, market, and competitive position data included in this prospectus is reliable and based on reasonable assumptions, we have not independently verified any third-party information, and all such data involve risks and uncertainties and are subject to change based on various factors. These and other factors could cause results to differ materially from those expressed in the estimates made by the independent parties and by us.
- 3. THERAPEUTICS PIPELINE Oral Biotherapeutics (OBDS) GI-Targeted Therapeutics (DDS) In development In development Rx
- 4. THERAPEUTICS PROGRAMS For drugs that today must be injected, our ingestible capsule technology could enable needle-free, oral delivery and systemic uptake of large molecules. For people who suffer from gastrointestinal diseases, delivering therapeutics directly to the site of disease could enable safer and more effective drug therapies. ORAL DELIVERY OF BIOTHERAPEUTICS GI-TARGETED THERAPEUTICS 4 ODBS Oral Biotherapeutics Delivery System DDS Drug Delivery System drug-device combinations
- 5. THERAPEUTICS PIPELINE 5 discovery PGN-OB2 GLP-1 agonist + OBDS PGN-OB1 Adalimumab variant + OBDS Antisense Therapy + OBDS In partnership with IONIS PHARMACEUTICALS Undisclosed Drug + OBDS PGN-001 Adalimumab variant + DDS PGN-600 Tofacitinib + DDS preclinical early clinical late clinical Undisclosed Drug + OBDS In partnership with LARGE PHARMA 2 In partnership with LARGE PHARMA 1 ORAL DELIVERY OF BIOTHERAPEUTICS: OBDS GI-TARGETED THERAPEUTICS: DDS drug-device combinations
- 6. OBDS: ORAL BIOTHERAPEUTICS DELIVERY SYSTEM 6 Needle-free, oral delivery to small intestine designed for optimal systemic uptake Large molecules/proteins are poorly absorbed in the intestine; currently delivered by injection only ► Injections are painful and inconvenient ► Oral delivery is an attractive alternative ► Oral delivery can differentiate molecules approved as biosimilars that would otherwise be injected ► Promising initial preclinical data with average bioavailability of ~15% of IV for PGN-OB1 following a single dose1 ► Initiated preclinical study of PGN-OB1 (variant of adalumimab) ► Initiated preclinical study of PGN-OB2 (GLP-1 agonist) Needle-free liquid jet injection in the small intestine designed for optimal systemic uptake of: ► monoclonal antibodies ► peptides ► nucleic acids UNMET NEED PRODUCT PROFILE DATA GENERATION 1. In animals where significant drug was detected
- 7. DDS: DRUG DELIVERY SYSTEMS 7 Targeted delivery of therapeutics to the site of disease intended to improve efficacy and safety Some diseases involving the GI tract, such as inflammatory bowel diseases (IBD), have extremely poor outcomes with existing therapies ► Efficacy is often limited by inability to achieve therapeutic drug levels due to safety concerns at higher doses ► Established IBD Clinical Advisory Board ► Completed preclinical study demonstrating high colon tissue concentrations and low systemic concentrations for PGN-600 (tofacitinib) ► Completed clinical study demonstrating device safety and function ► Designing first clinical study for PGN- 600 (variant of adalimumab) ► Continued funding from the Crohn’s & Colitis Foundation Replace systemic drug therapy with targeted, direct-to-site drug therapies designed to improve efficacy and safety ► Higher drug levels in the tissue where it is needed ► Lower drug levels in systemic circulation to reduce unwanted side effects UNMET NEED PRODUCT PROFILE DATA GENERATION
- 8. THERAPEUTICS MARKET OPPORTUNITY Our platforms and product candidates address markets valued at >100 billion with significant growth potential 1. Biologics Global Market Opportunities and Strategies to 2030: COVID-19 Impact and Recovery. Research and Markets; 2020. Report no. 5232536. 2. Monoclonal Antibody Therapy Market Size, Share & Industry Analysis, By Type, By Application, By Distribution Channel, and Regional Forecast, 2020-2027. Fortune Business Insights; 2020. Report no. FBI102734. 3. Inflammatory Bowel Disease Treatment Market Size, Share & Trends Analysis Report By Type (Crohn's Disease, Ulcerative Colitis), By Drug Class, By Route of Administration, By Distribution Channel, By Region, And Segment Forecasts, 2021 – 2028. Grand View Research; 2021. report no. GVR-3-68038-114-6. Global Biologics Market Monoclonal Antibodies IBD Therapeutics Market TOTAL ADDRESSABLE MARKETS (BILLIONS) $19 $123 OBDS 8 >$250 2 1 DDS 3
- 9. PROTEOMICS PLATFORM Preeclampsia In development
- 10. SIGNIFICANT UNMET NEED IN ASSESSING PATIENTS FOR PREECLAMPSIA 10 1. Henderson JT, et al. Preeclampsia Screening: Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2017 Apr 25;317(16):1668-1683. 2. Ananth CV, et al. Pre-eclampsia rates in the United States, 1980-2010: age-period-cohort analysis. BMJ. 2013 Nov 7;347:f6564 3. https://www.sciencedirect.com/topics/medicine-and-dentistry/gestational-hypertension 4. Center for Disease Control and Prevention. Births: Final Data for 2018 (In press), https://www.cdc.gov/nchs/nvss/births.htm ► DIAGNOSIS OF PREECLAMPSIA RELIES ON METHODS INVENTED IN THE 1800s Current assessment tools are sub-optimal ► THERE IS NO SINGLE TEST FOR PREECLAMPSIA Current tests, like blood pressure, are not specific to preeclampsia and cannot differentiate preeclampsia from other hypertensive disorders, such as chronic or gestational hypertension ► HEALTHCARE COST BURDEN OF $9 BILLION+1 Incremental costs associated with managing a preeclamptic pregnancy support value-based reimbursement #2 CAUSE of maternal mortality1 MORE THAN 700,000 PEOPLE present with symptoms each year2,3,4 UP TO $3 BILLION U.S. estimated market opportunity
- 11. PREECLUDIA™ TEST 11 For patients with symptoms of possible preeclampsia, the Preecludia test is potentially the first blood test to assess risk by evaluating multiple pathophysiological pathways. RULE-OUT TEST FOR PREECLAMPSIA PROGRAM UPDATES ► Submitted PRO-104 validation study manuscript to peer-reviewed journal; data is under embargo until publication ► Awarded patent for one of the key assays ► Engaged advisory firm and launched managed process to explore licensing the test to potential commercial partners ► PRO-104 validation study achieved a high NPV in line with original target at high prevalence rate and in a broad use population
- 12. PREECLUDIA publication & ongoing potential licensing efforts H2 2022 DIAGNOSTICS ORAL BIOTHERAPEUTICS DDS topline clinical PK/PD for adalimumab via enema in ulcerative colitis NEAR-TERM POTENTIAL CATALYSTS 12 Q4 2021 Q1 2022 Q2 2022 GI-TARGETED THERAPEUTICS OBDS preclinical PK data generation DDS device function study in ulcerative colitis patients DDS clinical PK/PD data generation OBDS clinical study initiation