Amplify Issuer Nasdaq Spotlight
Unicycive Therapeutics, Inc.
Unicycive Therapeutics is a biopharma company with development programs focused on two kidney diseases with largely unmet medical needs.
Nasdaq: UNCY
IR Website: https://ir.unicycive.com/
Headquarters: Los Altos, CA
It is developing Lanthanum Dioxycarbonate (LDO), an investigational phosphate binding agent using proprietary nanoparticle technology for the treatment of patients with hyperphosphatemia. They are also developing UNI-494, a novel new chemical entity that targets mitochondrial dysfunction which is in late preclinical development for the treatment of acute kidney injury.
TALK TO MANAGEMENT
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*Lanthanum Dioxycarbonate is an unapproved investigational new drug being developed under FDA’s 505(b)(2) regulatory procedure.
Unicycive Therapeutics At-A-Glance
Unicycive Therapeutics is a biopharma company with development programs that seek to improve quality of life of those suffering from kidney disease. Its pipeline of therapeutic drug candidates focuses on kidney diseases with high unmet patient and medical needs. For a look under the hood and to download a robust analysis of Unicycive Therapeutics, Inc., click below.
Lanthanum Dioxycarbonate: Utilizing Proven Mechanisms of Action
Treating End-Stage Renal Disease (ESRD) demands phosphate control in order to avoid heart failure. Current solutions for this problem demand an extremely burdensome and expensive regimen with very large pills. Lanthanum Dioxycarbonate is positioning itself to be a novel and elegant solution to this problem.
A Large Addressable Market
Chronic Kidney Disease is a very significant issue across much of the world. According to Research and Markets, the global end stage renal disease (ESRD) market size is anticipated to reach over $260 billion by 2030, leading to a very robust Compound Annual Growth Rate (CAGR) of 12.9% from 2022 to 2030.
Analyst Coverage
Firm |
Analyst |
Rating |
|
EF Hutton |
Elemer Piors, Ph.D. |
Buy |
|
H.C. Wainwright |
Edward Arce |
Buy |
|
Maxim Group |
Jason McCarthy, Ph.D. |
Buy |
|
The Benchmark Company, LLC |
Bruce Jackson |
Buy |
Unicycive Therapeutics, Inc. is followed by the analysts listed above. Please note that any opinions, estimates or forecasts regarding Unicycive Therapeutics, Inc.'s performance made by these analysts are theirs alone and do not represent opinions, forecasts or predictions of Unicycive Therapeutics, Inc., B2i Digital, Inc., or their respective management. Neither Unicycive Therapeutics, Inc. or B2i Digital, Inc. do not by its reference above or distribution imply its endorsement of or concurrence with such information, conclusions or recommendations.
Addressing Important Unmet Needs
Unicycive Therapeutics is a different type of biotech company. Unlike most firms in this space, Unicycive was built from the ground up in only three years. Additionally, they are focused on diseases of the kidney, a space that has had a shortage of effective and convenient solutions.
Chronic Kidney Disease (CKD) ranges between stages 1 through 5, with 1 being the least severe and 5 being the most. Stage 5 is called End-Stage Renal Disease (ESRD), where kidney function has declined to the point that patients require a kidney transplant or go on long-term dialysis to maintain life. At this late stage of CKD, elevated phosphorus, known as hyperphosphatemia, becomes a serious problem that needs to be addressed. Unfortunately, phosphate control can become a real challenge for CKD patients because, currently, available therapies require a burdensome number of large pills. Unicycive's drug Lanthanum Dioxycarbonate, if approved, promises to reduce that burden dramatically.
That phosphate control can become incredibly uncomfortable for ESRD sufferers as the number of pills that are necessary can be a major burden. Unicycive's drug Lanthanum Dioxycarbonate intends to reduce that burden dramatically.
Unicycive's management team and board of directors are steeped in experience, both in the medical industry as well as with drug commercialization. Additionally, their scientific board holds the impressive levels of experience and knowledge necessary to properly guide the firm and solve its most pressing issues.
Financing the Future
For any biotech company looking to build a pipeline and create the next important pharmaceutical, having strong financing in place is absolutely critical. You need to have enough of a runway to see that pharmaceutical solution from concept all the way through the regulatory process and out to market.
Unicycive recently announced that it has signed a securities purchase agreement with certain healthcare-focused institutional investors that will provide up to $130 million in gross proceeds to Unicycive through a private placement that includes initial upfront funding of $30 million.
Unicycive will issue to purchasers (i) $30 million in shares of the Company's Series A Convertible Preferred Stock and (ii) three tranches of warrants that are exercisable for convertible preferred stock as follows:
- The Tranche A warrants for an aggregate exercise price of approximately $25 million are exercisable until 21 days following the Company's announcement of receipt of FDA approval for Lanthanum Dioxycarbonate;
- The Tranche B warrants for an aggregate exercise price of approximately $25 million are exercisable until 21 days following the Company's announcement of receipt of TDAPA approval for Lanthanum Dioxycarbonate; and
- The Tranche C warrants for an aggregate exercise price of approximately $50 million are exercisable until 21 days following public disclosure of four quarters of commercial sales of Lanthanum Dioxycarbonate following receipt of TDAPA approval.
Proceeds from the offering will be used to support Unicycive's NDA submission with the FDA for approval of Lanthanum Dioxycarbonate for the treatment of hyperphosphatemia in the U.S. and, if approved, for the commercial launch of Lanthanum Dioxycarbonate in the U.S.
This puts Unicycive Therapeutics in an excellent position to both see Lanthanum Dioxycarbonate come to market as well as to see UNI-494 through its regulatory hurdles.
Pipeline
Unicycive Process
We see potential that others miss, and bring game-changing therapies to market via an end-to-end mining process.
Lanthanum Dioxycarbonate: Utilizing Proven Mechanisms of Action
Treating End-Stage Renal Disease (ESRD) demands phosphate control in order to avoid heart failure. Current solutions for this problem demand an extremely burdensome and expensive regimen with very large pills. Lanthanum Dioxycarbonate (LDO) is positioning itself to be a novel and elegant solution to this problem.
LDO is an advanced phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia. The nanotechnology allows the surface area of active drugs to increase, allowing for more medicine to be included in a smaller pill.
Unicycive has completed a clinical trial studying LDO in 32 healthy volunteers. In this study, LDO was minimally absorbed into the systemic circulation and was safe and well-tolerated at doses up to 6000 mg/day. LDO significantly reduced urine phosphate excretion and significantly increased fecal phosphate excretion at doses at and above 3000 mg/day.
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LDO is a novel investigational phosphate binder treatment for hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis
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MOA: LDO binds to dietary phosphate in the GI tract, which is then excreted via the feces resulting in the reduction of serum phosphorus levels
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Proprietary nanotechnology
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Enhanced surface area
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Lower molecular weight
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Immediate release tablets
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Smaller pills
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Swallowed (Not Chewed)
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* LDO is an unapproved investigational new drug being developed under FDA’s 505(b)(2) regulatory procedure. If approved, LDO will share the same product label and prescribing information as the reference-listed drug (RLD) Fosrenol (lanthanum carbonate), with the exception that LDO tablets are smaller in size and swallowed whole with water and not chewed
Unicycive Therapeutics will have patent protection until 2031, offering it the potential to deliver significant shareholder value for years to come.
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LDO is protected by a family of U.S. patents and a related family of patents outside the U.S.
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Both the U.S. patent family and the foreign patent family were filed in 2011, and the U.S. coverage has statutory expiry in 2031
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Corresponding patents granted in Canada, Europe, Japan, China, Australia, and other countries also have statutory expiration dates in 2031
UNI-494: Focused on Mitochondria
Unicycive believes the mitochondria is positioned to be a critical player in Acute Kidney Injury (AKI) with its dual role as the primary source of energy for each cell and as a key regulator of cell death.
In AKI mitochondrial damage leads to sublethal and lethal injury of kidney tubules and the consequent loss of renal function. In various models of AKI, mitochondrial dynamics are disrupted, and membrane integrity is compromised, resulting in the release of apoptogenic factors, mitochondrial permeability transition (MPT) pores, loss of membrane potential, energetic failure, and reactive oxygen species production to induce cell injury and death.
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There are currently no FDA approved medicines to treat AKI. The damage to the kidney is irreversible in most cases and the patient requires a renal transplant or lifelong dialysis.
UNI-494 is a novel new chemical entity that targets mitochondrial dysfunction which is in late preclinical development for the treatment of acute kidney injury AKI. Nicorandil has been shown in preclinical models to improve mitochondrial function by blocking the opening of MPTP pores in the inner mitochondrial membrane.
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UNI-494 is a novel pro drug of a marketed agent, nicorandil, with improved properties and long patent life
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Nicorandil has compelling published scientific data which supports development of UNI 494 for Acute Kidney Disease (AKI) and Chronic Kidney Disease (CKD)
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Pursuing AKI as initial indication with CKD as a follow on program
Unicycive Therapeutics currently is executing on their go-to-market strategy for UNI-494, with both preclinical studies and regulatory filing for the start of Phase 1 estimated to be completed by the end of 2022.
FDA Regulatory Strategy:
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Confirm pro-drug has acceptable tolerability in animal studies at desired doses
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Identify pro-drug dose(s) for initial human study, Demonstrate conversion of UNI 494 to nicorandil in humans
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Seek regulatory clearance to initiate Phase 1 study
Unique attributes for regulatory approval of UNI-494:
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Leverage pre clinical and clinical data from nicorandil outside United States with comparability package
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Design of more homogenous AKI patient population including patients with CIN where nicorandil has been shown to be efficacious
Milestones
Animal safety studies completed
Drug supplies for clinical studies manufactured
MHRA approval to initiate first in human trial
Phase 1 initiated (Q1 '23)
FDA IND filing for Phase 2 POC study
Investor Presentation
To download the Unicycive Therapeutics investor presentation, please fill out the form below.
Press Releases
Video Library: NASDAQ Amplify Issuer Spotlight and Interview with Doug Jermasek
In NASDAQ Amplify Issuer Spotlight, Dr. Shalabh Gupta, founder and CEO of Unicycive Therapeutics, discusses the company's mission to develop treatments for kidney disease. Kidney disease affects 14% of U.S. adults and leads to complications like heart disease and bone fractures.
Dr. Gupta explains the challenges with current phosphate-lowering drugs - high pill burden, large pill size, and bad taste leading to poor compliance. As highlighted in this NASDAQ Amplify Issuer Spotlight, Unicycive is on a mission to improve the lives of such patients.
The interview with Doug Jermasek, EVP at Unicycive Therapeutics, focuses on medication adherence challenges for dialysis patients with hyperphosphatemia (high phosphate levels). Five hundred thousand dialysis patients in the U.S. need phosphate binders, but 75% don't achieve recommended phosphate levels, mainly due to the high pill burden. Phosphate binders must be taken three times daily with meals for life. The most prescribed binder requires 9-12 large pills daily.
High pill burden leads to non-adherence, which increases mortality risk. Hyperphosphatemia is a "silent killer" - patients don't feel its effects, so they may stop treatment, like stopping antibiotics once infection symptoms resolve. Studies show that these patients' median daily pill burden is 19 pills, half being phosphate binders. Massive pill volume makes tracking adherence difficult—Unicycive aims to improve adherence with a far less burdensome regimen.
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Unicycive's Doug Jermasek EVP Corporate Development Talks Medication Compliance
Stock Chart (Intraday)
Stock Chart (Historical)
Stock Detail
SEC Filings
A Large Addressable Market
Chronic Kidney Disease is a very significant issue across much of the world. According to Research and Markets, the global end stage renal disease (ESRD) market size is anticipated to reach over $260 billion by 2030, leading to a very robust Compound Annual Growth Rate (CAGR) of 12.9% from 2022 to 2030. Increasing number of patients suffering from kidney failure, rapid increase in the volume of hospitals & urgent care centers, and growing hospital admission rates are thought to be the catalysts behind this growth. Both of the company's programs have potential to participate in this market.
Unicycive Therapeutics' lead program, Lanthanum Dioxycarbonate, is being designed to tackle the problem of hyperphosphatemia, or elevated phosphate levels. The company estimates that this market is currently sized at $2.46 billion and will have a 5.3% CAGR between 2021 and 2028.
Go-to-Market Strategy and Partnerships
In Q4 2022, Unicycive entered an agreement granting exclusive rights to develop, market and commercialize Lanthanum Dioxycarbonate to Lee’s Pharmaceutical (HK) Limited for Mainland China, Hong Kong and certain Asian markets. This agreement expands and accelerates the Lanthanum Dioxycarbonate opportunity in one of the largest and most important markets for patients through a local partner with deep domain expertise. The company received $1.0 million in upfront fee and is eligible for royalties on sales and other milestone payments. Unicycive will continues similar discussions with potential partners in Asia and Europe.
Deftly Navigating the Regulatory Maze
As with any company focusing on creating solutions for health issues, navigating the regulatory maze is critical for success. Unicycive has demonstrated a strong ability to do so.
LANTHANUM DIOXYCARBONATE:
The company's lead program Lanthanum Dioxycarbonate (LDO) is on a significantly de-risked regulatory pathway for commercialization; it received a response from the FDA in Q4 2021 in a Type C meeting that provided clear guidance to file a New Drug Application (NDA). The company is currently pursuing a 505(b)(2) pathway for U.S. approval (skipping clinical trial phases II and III), leveraging pre-clinical and clinical data from the existing approved lanthanum-containing phosphate binder, Fosrenol.
The company conducted a bioequivalence (BE) study comparing phosphorus changes between LDO and Fosrenol in healthy volunteers and a 6-month oral toxicity study in mice. LDO met all endpoints. In addition, the company began securing standard information on the manufacturability and commercial supply readiness of the product. Unicycive completed the environment of volunteers for BE study in Q4 2022.
Unicycive is on track to file the NDA in mid-2023. With a year of review, the company can expect potential FDA approval in 2024.
FDA Regulatory Strategy - based on Type C interaction and written response from FDA (Q4, 2021)
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505(b)(2) regulatory pathway for the potential U.S. approval of LDO
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Leverage pre-clinical and clinical data from existing lanthanum-based product (Fosrenol)
The strategy involved the following studies for the potential approval of LDO:
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Bioequivalence study in healthy volunteers comparing urinary phosphorus changes between LDO and Fosrenol.
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6-month oral toxicity study in mice.
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Standard information on manufacturability and commercial supply readiness of the product.
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Treatment-emergent adverse events were comparable between the LDO and Fosrenol groups.
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No subjects in the study experienced a serious adverse event (requiring hospitalization or study withdrawal.)
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There were no deaths in the study.
Commercial strategy underway to leverage large market opportunity
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Product positioning, market access, and market shaping activities are ongoing to optimize the value proposition
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Pursuing parallel commercial model pathways to address highly-concentrated nephrology market opportunity
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Partnership with pharma company already selling into the nephrology call point
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License and/or distribution deal(s) with Dialysis Organization(s)
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Outsourced contract sales organization
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*LDO is an unapproved investigational new drug being developed under FDA’s 505(b)(2 ) regulatory procedure. If approved, LDO will share the same product label and prescribing information as the approved reference listed drug (RLD) Fosrenol (lanthanum carbonate), with the exception that LDO immediate-release tablets are smaller in size and swallowed whole with water and not chewed.
UNI-494
Unicycive's other program, UNI-494, is also positioned well for a shorter approval timeframe. As a novel pro-drug of a marketed agent, nicorandil, it uses an established legacy with known MOAs and demonstrated safety and efficacy with its use of nitric oxide. It uses a known and safe chemical linker, and its controlled release of the active drug in plasma may enable QD dosing.
While nothing is guaranteed during this process, Unicycive Therapeutics is making intelligent decisions that may position it for commercialization in a much shorter timeframe than many other companies in the industry.
The company initiated clinical development of UNI-494 in the United Kingdom (UK) to expedite clinical development and filed a Clinical Trial Application (CTA) to the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK to initiate a Phase I healthy volunteer study.
Unicycive also filed an Investigational Drug Application (IND) with the FDA. A Phase II Proof-of-Concept (POC) study is expected in the second half of 2023.
Digging into the Science
Unicycive Therapeutics' drug candidates are focused on serious diseases of the kidney. Its lead program Lanthanum Dioxycarbonate hopes to address the challenging problem of uncontrolled hyperphosphatemia, with an elegant and patient-friendly solution to this serious complication faced by dialysis patients.
The drug binds to phosphates in the GI tract and they soon are excreted out, thus lowering their overall phosphate level. The proprietary nanotechnology of the drug ensures that more active medicine is packed into a smaller pill, leading to greater efficacy and convenience for the end user.
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Lanthanum Dioxycarbonate (LDO) is a novel phosphate binder treatment for hyperphosphatemia in patients with chronic kidney disease (CKD)
-
MOA: LDO binds to dietary phosphate in the GI tract which is then excreted via the feces resulting in reduction of serum phosphate levels
-
Proprietary nanotechnology
-
Enhanced surface area
-
Lower molecular weight
-
Immediate release tablets
-
Smaller pills
-
Swallowed (Not Chewed)
-
UNI-494 is Unicycive Therapeutics' other program, designed to help alleviate Acute Kidney Injury (AKI). It is intended to work on mitochondria, the "powerhouse of the cell", which along with energy production is also thought to target the kidney when they are malfunctioning.
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A hallmark feature of mitochondrial dysfunction is chronic opening of MPT Pores and overproduction of Reactive Oxygen Species (ROS)
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Chronic opening of MPT Pore leads to water and solute influx, injury and subsequent death
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UNI-494 is an ATP sensitive K channel (KATP) activator
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Binds to SUR2 subunit of KATP channel that in turn leads to closing of MPT pores
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Nicorandil down regulates production of ROS
Management Overview
Shalabh Gupta
Chief Executive Officer, President and Director
Shalabh Gupta, our founder, has served as our Chief Executive Officer, President and director since August 2016. Since June 2013, Dr. Gupta has also served as the founder and Chief Executive Officer of Globavir Biosciences, Inc., a company focused on commercializing novel therapeutics and powerful diagnostics for treating global infectious disease. Dr. Gupta has also served in various other capacities including founder and Chief Executive Officer of Biocycive Inc.; Strategy, Genentech Commercial at Genentech, Inc.; Equity Research, Pharmaceuticals at UBS Investment Bank; Attending Physician at NYU Medical Center; clinical faculty member at NYU School of Medicine; and Equity Research, Biotechnology at Rodman & Renshaw, LLC. In addition, he has served on the board of directors of Beall Center for Innovation and Entrepreneurship since 2018. Dr. Gupta has also served as an advisor to SPARK, Stanford University School of Medicine since 2012, a charter member of TiE, a not-for-profit network of entrepreneurs fostering entrepreneurship, mentoring and education, since 2013.
Dr. Gupta previously served on the board of directors of Phenomenome Discoveries Inc. and was a Fellow at the Startup Leadership Program, a medical advisor Synageva BioPharma Corporation (formerly known as AviGenics) and an advisor to NYU Langone Medical Center (Office of Technology Transfer). Dr. Gupta received his MPA in health care finance and management from NYU Robert F. Wagner Graduate School of Public Service, and his medical degree from Jawaharlal Institute of Postgraduate Medical Education & Research, India. Furthermore, Dr. Gupta completed his internship in Internal Medicine, and medical residency in physical medicine and rehabilitation and a research fellowship in cardiopulmonary rehabilitation from New York University (“NYU”) School of Medicine and New York University. He practiced medicine from 2000 to 2008 at NYU’s various hospitals first during his medical training (2000-2004) and then as an attending physician (2004-2008).
Dr. Gupta also served as a faculty member at NYU School of Medicine. In the past, Dr. Gupta was a board-certified physician, and he currently holds a license from the California State Medical Board. While working as a stock analyst on Wall Street, Dr. Gupta held Series 7, 63, 86 and 87 licenses. We believe Dr. Gupta is qualified to serve as a member of our board of directors because of his background as a physician and as a biotechnology executive and his extensive experience in both in-licensing technologies from academic institutions and biotechnology companies as well as out-licensing technologies to larger organizations in addition to his former experience on Wall Street.
John Townsend
Chief Financial Officer
Mr. John Townsend, CPA, Chief Financial Officer at Unicycive Therapeutics Inc. Previously, he has served as Vice President Finance and Chief Accounting Officer in a consulting role for Unicycive. He has over 25 years of public and private company experience in industries including biotechnology, medical devices, and high-tech electronics manufacturing. Before joining Unicycive, Mr. Townsend worked at Guardion Health Sciences, a medical foods company from 2016 to 2020. From 2005 until 2015, he worked at Cytori Therapeutics, Inc., a stem cell therapy company. From 1996 to 2005, he worked at several high-tech companies. Mr. Townsend started his career at Deloitte (formerly Deloitte and Touche) after graduating from San Diego State University in 1993. Mr. Townsend is a Certified Public Accountant in the state of California.
Douglas Jermasek
Executive Vice President, Corporate Strategy
Douglas Jermasek joined Unicycive in 2021 as Executive Vice President, Corporate Strategy. Mr. Jermasek is a seasoned biopharmaceutical executive with over 25 years of commercial leadership experience in both U.S. and international markets. Most recently, he served as Senior Vice President, Marketing and Strategy at Akebia Therapeutics, a role he assumed after the merger with Keryx Biopharmaceuticals. Previously he spent over a decade at Genzyme (a Sanofi Company) culminating as Senior Vice President and General Manager, Head of Renal Global Business Unit. In that role, he drove sales of over $1 billion, establishing Renvela® as the standard of care for the treatment of hyperphosphatemia for patients with chronic kidney disease (CKD) and achieving “blockbuster” status globally. Earlier, he held management positions of progressive responsibility at Intercept Pharmaceuticals, Prometheus Laboratories, Agouron Pharmaceuticals, and Abbott Laboratories. Mr. Jermasek holds a Master’s degree in Business Administration from the Marriott School of Management at Brigham Young University and a Bachelor’s degree in Biological Science also from BYU.
Guru Reddy, PhD
Vice President, Preclinical R&D
Guru Reddy, PhD, joined Unicycive in 2022 as Vice President of Preclinical R&D. Dr. Reddy has more than 25 years of R&D experience in the biopharmaceutical industry. Prior to joining Unicycive, he worked at Spectrum Pharmaceuticals for 15 years, where he held R&D roles with increasing responsibilities serving most recently as the Vice President of Preclinical R&D. At Spectrum Pharmaceuticals, he was responsible for the preclinical development and clinical pharmacology of a large product pipeline culminating in multiple NDA submissions and full regulatory approval of 4 drugs from the US FDA.
Dr. Reddy has a wide range of experience in drug development, including preclinical research & development, early clinical development, regulatory strategy.
Dr. Reddy earned his PhD in biochemistry from the University of Poona/National Chemical Laboratory in India and obtained his post-doctoral training at Yale University. He is an inventor on 17 granted US patents and co-authored over 30 peer-reviewed publications.
Pramod Gupta, PhD
Executive Vice President, Pharmaceutical & Business Operations
Pramod Gupta, PhD, serves as the Executive Vice President of Pharmaceutical & Business Operations at Unicycive Therapeutics Inc. Previously, he worked as SVP of Pharmaceutical Operations at Spectrum Pharmaceuticals, Global VP at Bausch & Lomb, Senior Director of R&D at Baxter Healthcare, Director of R&D at TAP Pharmaceuticals (joint venture of Abbott & Takeda) and R&D Project Leader at Abbott Pharmaceuticals.
During this time, Dr. Gupta developed, received regulatory approvals from US FDA and other international agencies, and commercialized over 40 pharmaceutical products. He received his PhD in Pharmaceutical Sciences from the University of Otago in New Zealand. He is holder of 12 granted patents, and he has published over 50 scientific papers.
Risks & Disclosures
This communication is neither an offer to sell nor a solicitation of an offer to buy, nor a recommendation of any securities of the company mentioned herein.
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Information, opinions and estimates contained on this page or in the Company Presentation reflect judgments by the Company as of the original date of publication by the Company and are subject to change without notice. Past performance should not be taken as an indication or guarantee of future performance, and no representation or warranty, express or implied is made regarding future performance.
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Unicycive Therapeutics Under the Hood
Unicycive Therapeutics is a different type of biotech company. Unlike most firms in this space, Unicycive was built from the ground up in only three years. Additionally, they are purely focused on chronic kidney diseases, an issue that has had a shortage of effective and convenient solutions.