NeuroBo Pharmaceuticals, Inc.
May 2024
NASDAQ: NRBO | 1 |
Forward-Looking Statements
This presentation may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or current facts and can be identified by the use of words such as "believes", "expects", "anticipates", "may", "will", "should", "seeks", "approximately", "intends", "projects," "plans", "estimates" or the negative of these words or other comparable terminology (as well as other words or expressions referencing future events, conditions or circumstances). Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. These forward-looking statements include statements regarding the market size and potential growth opportunities of our current and future product candidates, capital requirements and use of proceeds, clinical development activities, the timeline for, and results of, clinical trials, regulatory submissions, and potential regulatory approval and commercialization of its current and future product candidates. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, those risks associated with our ability to execute on its commercial strategy; the timeline for regulatory submissions; ability to obtain regulatory approval through the development steps of our current and future product candidates, the ability to realize the benefits of the license agreement with Dong-A ST Co. Ltd., including the impact on future financial and operating results of NeuroBo; the cooperation of our contract manufacturers, clinical study partners and others involved in the development of our current and future product candidates; potential negative interactions between our product candidates and any other products with which they are combined for treatment; our ability to initiate and complete clinical trials on a timely basis; our ability to recruit subjects for our clinical trials; whether we receive results from our clinical trials that are consistent with the results of pre-clinical and previous clinical trials; impact of costs related to the license agreement, known and unknown, including costs of any litigation or regulatory actions relating to the license agreement; effects of changes in applicable laws or regulations; whether we are able to maintain compliance with Nasdaq listing requirements; and effects of changes to our stock price on the terms of the license agreement and any future fundraising. These forward-looking statements are based on information currently available to us and our current plans or expectations and are subject to a number of known and unknown uncertainties, risks and other important factors that may cause our actual results, performance or achievements expressed or implied by the forward-looking statements. These and other important factors are described in detail in the "Risk Factors" section of our Annual Report on Form 10-K for the year ended December 31, 2023 and our other filings with the Securities and Exchange Commission.
While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to this presentation.
This presentation also may contain estimates and other statistical data made by independent parties and by us relating to market size and other data about our industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. In addition, projections, assumptions and estimates of our future performance and the future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk.
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Strong Leadership Team
Management Team
Hyung Heon Kim, Chief Executive Officer |
- 20+ years of experience in M&A, financing and corporate governance
- 10+ years of licensing, M&A and compliance with Dong-A Group
- Former General Counsel/SVP at Dong-A ST and Dong-A Socio Group
- BA Soonghsil University, JD Washington University School of Law
Marshall H. Woodworth, Chief Financial Officer |
- 35+ years of financial experience
- 20+ years working with life science investors and analysts
- CFO of Nevakar Inc., Braeburn Pharmaceuticals Inc., Aerocrine AB and Furiex Pharmaceuticals Inc.
- BS University of Maryland, MBA Indiana University
Mi-Kyung Kim, Ph.D., RPh, Chief Scientific Officer |
- 25+ years in drug discovery research at Dong-A ST
- Specialized in diabetes, obesity, MASH, immune-mediated diseases
- Ph.D., RPh, College of Pharmacy, Ewha Womans University
Robert Homolka, SVP Clinical Operations |
- 35+ years in pharmaceutical and biotech development
- Sr. director of clinical operations in Adiso Therapeutics
- Director of clinical operations at Shire/Takeda pharmaceuticals
- Director of experimental trial management at AstraZeneca
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Compelling Investment Opportunity
Targeting Obesity and MASH with a Pipeline of Next Generation Therapeutics
- Aiming to Increase Shareholder Value through Multiple, Near-Term, Value Creating Milestones
- DA-1726
- Open IND for Treatment of Obesity
- First patient dosed and actively recruiting into a Phase 1 for obesity
- DA-1241
- Open IND for Treatment of MASH and Type 2 Diabetes
- Actively recruiting into a Phase 2a for DA-1241 in subjects with presumed MASH
- Completed SAD and MAD studies (in healthy volunteers and subjects with T2D)
- Backed by Strategic Partner and Major Shareholder, Dong-A ST
- Well Capitalized With $16.0 million in Cash at the end of Q1 2024. Cash runway into Q4 2024
- Exploring Strategic Opportunities to out-license legacy assets
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Pipeline
AssetIndicationPreclinicalPhase 1
Phase 2
2a2b
DA-1241 MASH
(GPR119 Agonist)
DA-1726 | Obesity OBESITY |
(GLP1R/GCGR Dual Agonist)
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Multiple Near-Term Milestones:
Targeting to Increase Shareholder Value
Investments in the current DA-1241Phase 2a and DA-1726Phase 1 have the potential for significant returns in the event of clinical and regulatory success
2024
DA-1241
2025 | |||
Q3 2024 | Q4 2024 | ||
Q1/Q2 2025 | |||
Phase 2a | Phase 2a | ||
Meeting with FDA | |||
Last Patient Last Visit | Top Line Results | ||
DA-1726
√ Q1 2024 | √ Q2 2024 | Q3 2024 | |||
Phase 1 | Phase 1 (Part 1) | Phase 1 (Part 1) Last Patient | |||
IND No Objections | First Patient In | Visit | |||
Q3 2024 | Q4 2024 | Q1 2025 | |||
Phase 1 (Part 1)Top Line | Phase 1 (Part 2) Last Patient | Phase 1 (Part 2) Top | |||
Results | Visit | Line Results | |||
Q3 2024 | Q2 2025 | ||||
Phase 1 (Part 2) First | Phase 1 (Part 3) IND | ||||
Patient In | Update Submission | ||||
* These milestones assume regulatory and clinical success, which is not guaranteed
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DA-1726: Upcoming Phase 1 Part 3 Trial in Obesity Timeline
Phase 1 Part 3 will assess total weight loss at 24 weeks, exploring maximum titratable dose and dietary changes.
2025
DA-1726
Part 3
2026
Q2 2025 | Q3 2025 | Q4 2025 | H1 2026 | H2 2026 |
Part 3 | Part 3 | Part 3 | Part 3 | Part 3 |
IND Update Submission | First Patient Dosed | Last Patient Enrolled | Last Patient Visit | Top Line Results |
Q2 2025 | ||||
Part 3 | ||||
IRB Approval | ||||
* These milestones assume regulatory and clinical success, which is not guaranteed
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DA-1726: Upcoming Phase 1 Part 3 to Evaluate Maximum Titratable Dose
Study Objectives
- Gain an understanding of drug titration and dosing
- Time to maximum-tolerated dose
- Titration up to the maximum-tolerated individualized dose
Exploratory Efficacy Endpoints
- Evaluate total weight loss at 24 weeks - change in baseline at maximum-tolerated individualized dose to the end of treatment period
- Explore dietary changes including caloric intake and composition
- Explore type of weight loss - lean muscle mass versus fat loss
- Evaluate sustained weight loss after discontinuation
Study Design | ||
Study Overview | A multicenter, randomized, double-blind,placebo-controlled, Phase 1 clinical trial to evaluate the | |
efficacy and safety of DA-1726 in obese, otherwise healthy subjects | ||
Additional Endpoints | Biomarker changes (PK, PD) | |
| Longer term safety (i.e., AEs, Lab, ECG) | |
| 3 Period design | |
Study Design | • Titration Period - up to 12 weeks | |
• Treatment Period - at least 12 weeks at individualized maximum titratable dose | ||
• Off-Drug Period - up to 8 weeks | ||
No. of Subjects and Location | | Approximately 50 subjects randomized in a 4:1 ratio of DA-1726 or Placebo at multiple centers in the United States |
Enrollment (estimated) | | FPFV Q3 2025 |
| LPLV 1H 2026 | |
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Notes: FPFV (First Patient First Visit); LPLV (Last Patient Last Visit); PK (Pharmacokinetic); PD (Pharmacodynamic)
DA-1726
A Novel GLP1R/GCGR Dual Agonist for the Treatment of Obesity
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DA-1726: Indication - Obesity - Competitive Differentiation
Pemvidutide | DA-1726 | Mazdutide | Survodutide | Semaglutide | Tirzepatide | ||
Innovent Biologics | |||||||
Developer | Altimmune | NeuroBo | Boehringer Ingelheim | Novo Nordisk | Lilly | ||
Lilly | |||||||
Status | Phase 1 | Phase 3 (China, 9mg) | Marketed (Obesity/Wegovy®) | Marketed | |||
Phase 3 ready | Phase 2 (USA) | Phase 3 | (Obesity/Zepbound®) | ||||
Marketed (T2D/Ozempic®) | |||||||
NDA in China for 6mg | Marketed (T2D/Mounjaro®) | ||||||
Action | GLP-1R/GCGR (Glucagon receptor) | GLP-1R/GCGR | GLP-1R/GCGR | GLP-1R/GCGR | GLP-1R agonist | GLP-1R/GIPR | |
(1:1) * | (3:1) * | (Undisclosed) * | (8:1) * | (Unknown) | |||
(NA) | |||||||
dual agonist | dual agonist | dual agonist | dual agonist | dual agonist | |||
Dosage | once weekly, injection | Exploratory dosing | once weekly, injection | once weekly, injection | once weekly, injection | once weekly, injection | |
in Phase 1 | |||||||
Efficacy in | Body weight loss, | Exploratory efficacy | Body weight loss, | Body weight loss, | Body weight loss, | Body weight loss, | |
15.6% @ 48-week | 18.6% @ 48-week | ||||||
Human | in Phase 1 | 18.7% @ 46-week | 14.8% @ 68-week | 20.9% @ 72-week | |||
(high dose 2.4mg) | (placebo adjusted, 9mg) | ||||||
Nausea, diarrhea, vomiting, | Nausea, vomiting, diarrhea, | Nausea, diarrhea, | Nausea, diarrhea, | ||||
Nausea, vomiting, diarrhea, etc. | constipation. | ||||||
Safety in | Exploratory safety | abdominal distension. | vomiting, constipation, | decreased appetite, vomiting, | |||
Treatment discontinuations | |||||||
Discontinuations due to adverse | No discontinued treatment | abdominal pain. | constipation. | ||||
Human | in Phase 1 | due to AEs: 24.6% | |||||
events 19.6% (high dose 2.4mg) | due to adverse events during | Treatment discontinuations | Treatment discontinuations | ||||
(BI: due to rapid dose | |||||||
9mg Phase 2 | due to AEs: 7% for 2.4mg | due to AEs: 6.2% for 15mg | |||||
escalation) | |||||||
• Weight loss similar or better as | |||||||
• | compared to semaglutide | ||||||
Differentiation | Better tolerability due to | ||||||
balance approach as compared | |||||||
to semaglutide | |||||||
Note : Above GLP-1R/GCGR relative ratio are based on publicly available data and internal research data. | 10 |
These results may vary depending on methodologies used for calculation. |
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NeuroBo Pharmaceuticals Inc. published this content on 21 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 21 May 2024 16:22:04 UTC.