UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 7.01. | Regulation FD Disclosure. |
On May 15, 2023, Cara Therapeutics, Inc. (the “Company”) made available an updated corporate presentation, which can be found on the Company’s website (the “Corporate Presentation”). The Corporate Presentation is furnished as Exhibit 99.1 and incorporated by reference in this Item 7.01.
The information furnished under this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference into any of the Company’s filings with the Securities and Exchange Commission (“SEC”) under the Exchange Act or the Securities Act of 1933, as amended, whether made before or after the date hereof, regardless of any general incorporation language in such a filing. The information shall not be deemed incorporated by reference into any other filing with the SEC made by the Company, regardless of any general incorporation language in such filing.
| Item 9.01. | Financial Statements and Exhibits. |
| (d) | Exhibits |
| Exhibit No. | Description |
| 99.1 | Corporate Presentation, dated May 15, 2023 |
| 104 | Cover page interactive data file (formatted as Inline XBRL) |
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.
| CARA THERAPEUTICS, INC. | ||
| By: | /s/ CHRISTOPHER POSNER | |
| Christopher Posner | ||
| Chief Executive Officer | ||
Date: May 15, 2023
Exhibit 99.1
Corporate Presentation May 2023
2 Forward - Looking Statements Statements contained in this presentation regarding matters that are not historical facts are "forward - looking statements" withi n the meaning of the Private Securities Litigation Reform Act of 1995. Examples of these forward - looking statements include statements concerning the Company’s ability to successfully commercialize KORSUVA injection and Kapruvia , future revenue and profit share from sales of KORSUVA and Kapruvia , planned future regulatory submissions and potential future regulatory approvals, potential for post - TDAPA reimbursement of KORSUVA, future product launches, the performance of the Company’s commercial partners, including CSL Vifor, expected timing of the initiation, enrollment and data readouts from the Company’s planned and ongoing clinical trials , t he potential results of ongoing clinical trials, timing of future regulatory and development milestones for the Company’s produc t c andidates, the potential for the Company’s product candidates to be alternatives in the therapeutic areas investigated and the potential fo r oral difelikefalin to address additional pruritic indications, the size and growth of the potential markets for pruritus management, and the Company’s expected cash reach. Because such statements are subject to risks and uncertainties, actual results may differ mate ria lly from those expressed or implied by such forward - looking statements. These risks and uncertainties include the risks inherent in the launch of new products, including that our commercial partners, including CSL Vifor, may not perform as expected, risks inher ent in the clinical and regulatory development of pharmaceutical products, and the risks described more fully in Cara Therapeutics’ fili ngs with the Securities and Exchange Commission, including the “Risk Factors” section of the Company’s Annual Report on Form 10 - K for the yea r ending December 31, 2022 and its other documents subsequently filed with or furnished to the Securities and Exchange Commissi on , including its Form 10 - Q for the quarter ended March 31, 2023 . All forward - looking statements contained in this presentation speak only as of the date on which they were made. Cara Therapeutics undertakes no obligation to update such statements to reflect events t hat occur or circumstances that exist after the date on which they were made, except as required by law.
3 Our Mission: To be the leader in the treatment of chronic pruritus with a vision to transform the way pruritus is treated and improve the quality of life for millions of people who suffer. 3
4 Difelikefalin, a Pipeline in a Product Novel, first - in - class selective and potent kappa opioid receptor agonist Unique Chemical Structure and Features • Synthetic peptide made of non - natural amino acids • High hydrophilicity, high polar surface area and charge at physiological pH • Does not readily cross the blood - brain - barrier Differentiated MOA • Acts on KORs on peripheral terminals of sensory nerves and immune cells • Works downstream potentially as broad spectrum antipruritic Attractive Pharmacology • Highly selective and potent full agonist at KORs • Does not produce classical mu opioid side effects (e.g., euphoria, addiction and respiratory depression) • Non - scheduled drug Strong Clinical Data in Multiple Therapeutic Areas • IV formulation approved for chronic kidney disease - associated pruritus (CKD - aP ) in hemodialysis patients • Oral formulation has shown positive clinical data in the treatment of chronic pruritus – CKD - aP in pre - dialysis patients – Atopic Dermatitis – Notalgia Paresthetica
5 Focus on Moderate to Severe Chronic Pruritus NEPHROLOGY DERMATOLOGY Advanced CKD Hemodialysis Advanced CKD Pre - Dialysis Atopic Dermatitis Notalgia Paresthetica APPROVED PHASE 3 PHASE 3 PHASE 2/3 ~ 200K patients undergoing hemodialysis (HD) suffer from moderate - to - severe chronic pruritus KORSUVA injection is the first - and - only FDA approved product to help these patients. ~ 300K patients with stage 4 - 5 advanced CKD suffer from moderate - to - severe chronic pruritus There are no approved therapies. ~ 3M mild - to - moderate patients with Atopic Dermatitis (AD) suffer from moderate - to - severe chronic pruritus Chronic pruritus is one of the defining features of AD. ~ 650K patients with Notalgia Paresthetica (NP) are in the care of a healthcare provider for moderate - to - severe chronic pruritus There are no approved therapies.
6 KORSUVA ® Injection Launch Underway * Vifor has contracted the sales force of Fresenius Renal Pharmaceuticals, a division of Fresenius Medical Care North America, to com pl ement its sales force in selling into Fresenius clinics in the U.S. NOTE: Korsuva is indicated for the treatment of moderate - to - severe pruritus associated with chronic kidney disease (CKD - aP ) in adults undergoing hemodialysis (HD). Limitations of Use Korsuva has not been studied in patients on peritoneal dialysis and is not recommended for use in this population First - and - only product approved for CKD - aP in HD in countries worldwide • US launch in 2Q22 • EU launch ( Kapruvia ) in 2H22 • AU, CA, SA, SG approvals in 2H22 – launches planned • JP approval expected 2H23 Strong Commercial Partnership with Favorable Economics • Leading commercial nephrology organization with 100+ sales FTEs in US • Strong relationships with US nephrology offices and dialysis centers • Joint venture with Fresenius Medical Care* Only Current Product with TDAPA Designation • Concentrated payer market with ~80% Medicare • Reimbursed at ASP for a minimum of two years • Positive dialogue with CMS regarding post - TDAPA reimbursement
7 Pruritis control is a significant unmet need among non - dialysis CKD patients 1 There are no FDA - approved therapies and current anti - pruritic approaches are inadequate 1,2 Approximately 1.2 million US patients have advanced (stage 4 - 5) non - dialysis CKD 3 - 6 ~30% advanced non - dialysis CKD patients experience moderate to severe pruritus 7 Oral Difelikefalin : Expanding Reach into Non - dialysis CKD - aP Market 1. Makar M et al. Chronic kidney disease associated pruritus: a review. Kidney Blood Press Res 2021. 46:659 - 669. 2. Mettang T and Kremer AE. Uremic Pruritus. Kidney International. 2015. 87:685 - 691 3. Centers for Disease Control and Prevention https://nccd.cdc.gov/ckd/detail.aspx?Qnum=Q372. 4. DataMonitor 5. States Renal Data System https://adr.usrds.org/2020/chronic - kidney - disease/1 - ckd - in - the - general - population. 6. Wong SJY et al. Decisions about Ren al Replacement Therapy in Patients with Advanced Kidney Disease in the US Department of Veterans Affairs, 2000 – 2011. Clin Journal of Am Soc Neprol. 2016. 11(10): 1 825 - 1833. 7. Sukul N et al. Pruritus and patient reported outcomes in non - dialysis CKD. Clin J Am Soc Nephrol 2019. 673 - 681. 7
8 RUN - IN Efficacy Assessment Treatment Period (Double Blind) Long - term Safety Extension Treatment Period (Double Blind) KICK 1 & KICK 2: Phase 3 Study Design in CKD KICK1 US sites only, KICK 2 US and ex - US sites Patients Re - Randomized to DFK or PBO RANDOMIZE (N = ~400; 1:1) Placebo QD DFK 1.0 mg QD Placebo QD DFK 1.0 mg QD Topline Results: 2H2024 est. 12 Weeks PRIMARY ENDPOINT • % of subjects with ≥4 - point improvement from baseline in WI - NRS score at Week 12 ADDITIONAL ENDPOINTS • Quality of life, including sleep • Safety assessments 7 Days SCREENING DFK 1.0 mg QD Up to 52 Weeks Placebo QD Baseline Mean WI - NRS > 5 Program initiated in 1Q22, enrollment ongoing
9 Oral Difelikefalin : Potential to Address Significant Need for an Oral Antipruritic in Atopic Dermatitis (AD) 1. Correale CE et al. Atopic dermatitis: a review of diagnosis and treatment. Am Fam Physician. 1999. 60(4):1191 - 1198 2. Silverberg JI et a l. Patient burden and quality of life in atopic dermatitis in US adults. Annals of Allergy, Asthma, and Immunology (2018). 121(3): 340 - 347 3. Legat FJ. Itch in atopic dermatitis – what is new? Front Med (Lausanne) 2021. 8:644760. 4. Barbarot S, Auziere S, Gadkari A, et al. Epidemiology of atopic dermatitis in adults: results from an international survey. Allergy. 2018;73(6):1284 - 1293. 5. United States Census Bureau 2020 . 6. Raj Chovatiya MD, PhD , Donald Lei MS , Adnan Ahmed BS, Rajeev Chavda MD, Sylvie Gabriel MD, Jonathan I. Silverberg MD, PhD, MPH , Clinical phenotyping of atopic dermatitis using combined itch and lesional severity: A prospective observational study, Annals of Allergy, Asthma Immunology (2021). Pruritus is a hallmark of AD, often called “the itch that rashes” 1 Itch is considered the most burdensome AD symptom by patients 2 , strongly and negatively impacts quality of life 3 Target “itch dominant” adult AD patients (~25% of market or ~3M) with moderate to severe pruritus, but mild to moderate disease 4 - 6 Pruritus in AD remains an unmet need 9
10 Oral Difelikefalin: Targeting Itch Dominant Adult AD Market Differentiated positioning in a seemingly crowded market • Sizeable Target Market 12M adult AD patients 80% mild - moderate AD 30% moderate - severe itch • Itch Dominant 1 AD Market Significant Unmet Need Patients with mild to moderate lesions, but moderate to severe itching • Preferable Product Characteristics Oral, non - steroidal, non - biologic therapy Severe Mild Severe 3.0M patients 1.7M patients Biologics JAKs Skin Lesions Pruritus 7.6M patients Topicals Difelikefalin 1. Raj Chovatiya MD, PhD , Donald Lei MS , Adnan Ahmed BS, Rajeev Chavda MD, Sylvie Gabriel MD, Jonathan I. Silverberg MD, PhD, MPH , Clinical phenotyping of atopic dermatitis using combined itch and lesional severity: A prospective observational study, Annals of Allergy, Asthma Immunology (2021).
11 KIND 1 & KIND 2: Phase 3 Study Design in AD RUN - IN Double Blind Treatment Period Long - term Safety Extension Treatment Period (Open Label) 12 Weeks 7 Days Up to 52 Weeks Topline Results: 1H2025 est. Oral DFK XX mg BID + TCS Oral PBO BID + TCS KIND 1 Part A will include sites in USA only KIND 1 Part B will include sites in North America only, while KIND 2 will include sites in North America and outside of North America RUN - IN Double Blind Treatment Period Long - term Safety Extension Treatment Period (Open Label) 12 Weeks 7 Days Up to 52 Weeks KIND 1 Part A KIND 1 Part B and KIND 2 Internal Readout Dose | Sample Size Baseline Mean WI - NRS > 5 Oral PBO BID + Vehicle PBO Oral DFK 0.25 mg BID + TCS Oral DFK 0.5 mg BID + TCS Oral PBO BID + TCS PRIMARY ENDPOINT • % of subjects with ≥4 - point improvement from baseline in WI - NRS score at Week 12 ADDITIONAL ENDPOINTS • Quality of life, including sleep • Skin assessment • Safety assessments RANDOMIZE (N = ~ 28 0; 1:1:1:1) Program initiated in 1Q22, enrollment ongoing
12 NP is a sensory neuropathic syndrome characterized by chronic pruritus 1 Pruritus is burdensome and impairs quality of life 2 Estimated >650K patients currently treated for NP 1, 3 - 5 No FDA - approved treatments; off label treatments are either ineffective or have tolerability issues 2 Oral Difelikefalin : Potential to Address Significant Need in Notalgia Paresthetica (NP) 1. Pereira P. et al., Acta DV 2018 ; 98:82 - 88; 2. Howard M et al. Notalgia paresthetica: a review for dermatologists. Int J of Derm . 2017. 388 - 392. 3. US Census Bureau 2020 population projection; 4. Mollanazar N.K. et al., Acta Clin Croat 2018; 57:721 - 725 ; 5. Syneos Health qualitative primary research of US dermatologists, Feb 2022; 5. Syneos market research and Apollo claims database 12
13 PRIMARY ENDPOINT % of subjects with ≥4 - point improvement from baseline in WI - NRS score at Week 8 RUN - IN Double Blind Treatment Period Long - term Safety Extension Treatment Period (Open Label) 8 Weeks 7 Days Up to 52 Weeks RUN - IN Double Blind Treatment Period 8 Weeks 7 Days Part A Part B and Second Study Internal Readout Dose | Sample Size Baseline Mean WI - NRS > 5 Oral PBO BID Oral DFK 0.25 mg BID Oral DFK 1.0 mg BID Oral DFK 2.0 mg BID RANDOMIZE (N = ~ 20 0; 1:1:1:1) Phase 2/3 Study Design in NP Program initiated in 1Q23 Oral DFK XX mg BID Oral PBO BID
14 Catalysts to Drive Long - term Growth* *Anticipated Timelines KICK 1 & 2 NDD - CKD Phase 3 Topline Data (2H 2024) Initiation KOURAGE 1 Part A NP Phase 2/3 (1Q 2023) KIND 1b & 2 AD Phase 3 Topline Data (1H 2025) KIND 1 Part A AD Phase 3 Internal Readout (4Q 2023) 2025 2024 2023 KOURAGE 1 Part A NP Phase 3 Internal Readout (2H 2024) KORSUVA approval Japan (2H 2023) KORSUVA® Injection US Commercialization - Launched April 2022 Kapruvia /KORSUVA International Commercialization - Launched September 2022
15 Strong Financial Foundation to Advance Pipeline and Drive Long - term Growth Continued pipeline growth • Sufficient resources to continue development of the oral difelikefalin platforms $123M cash position as of March 31, 2023 • 54M shares outstanding and no debt • Cara has no cash outlay for commercial costs related to Korsuva/ Kapruvia Injection Cash runway into the second half of 2024
Thank You
Appendix
18 Primary Endpoint Phase 2 Data Provides Path Forward into Phase 3 NDD - CKD • Significant difference achieved between 1mg oral difelikefalin and placebo in WI - NRS score at Week 12 • Generally well - tolerated with safety profile consistent with clinical development program • Phase 2 findings and EOP2 discussion with FDA established dose and patient population in Advanced CKD for Phase 3 trial Change from Baseline in WI - NRS over Time
19 Population: Mild to Moderate AD (BSA <10) KARE STUDY: Phase 2 Data in Atopic Dermatitis (AD) • A nti - pruritic effect started at week 1 and was sustained through week 12 • Statistical significance achieved for the registration endpoint (4 - point responder) in mild - to - moderate AD population • The drug was generally well tolerated 4 - point Responder Analysis at Week 12 (% of Subjects) N = 79 N = 178 Placebo Difelikefalin P=0.033 19% 32%* All doses (0.25mg, 0.50 mg , 1.0mg) performed similarly versus PBO
20 Primary Endpoint Change from Baseline in WI - NRS at Week 8 Encouraging Phase 2 Data in First Well - Controlled NP Study • Significant difference achieved between 2 mg BID oral difelikefalin and placebo in WI - NRS score at Week 8 • Rapid onset of action within Week 1 and sustained response through Week 8 • Significantly greater proportion of patients on difelikefalin with ≥ 4 - point improvement starting Week 2 • Generally well - tolerated with safety profile consistent with other clinical development programs LS Means from MMRM with terms for treatment, week, treatment by week interaction, and baseline WI - NRS score Missing data imputed using multiple imputation (MI) under missing at random (MAR) assumption