8-K
MetaVia Inc. (MTVA)
8-K
2024-02-14
For: 2024-02-14
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April 06, 2026
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): February 14, 2024
NEUROBO PHARMACEUTICALS, INC.
(Exact name of Registrant as Specified in Its Charter)
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| Delaware | **** | 001-37809 | **** | 47-2389984 |
| (State or other jurisdiction<br><br>of incorporation) | | (Commission<br><br>File Number) | | (IRS Employer<br><br>Identification No.) |
545 Concord Avenue, Suite 210
Cambridge , Massachusetts **** 02138
(Address of principal executive offices, including Zip Code)
Registrant’s Telephone Number, Including Area Code: ( 857 ) 702-9600
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:
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| ☐ | 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:
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| Title of each class | Trading<br><br>Symbol(s) | Name of each exchange on which registered | |
| Common Stock, par value 0.001 per share | NRBO | The Nasdaq Stock Market LLC |
All values are in US Dollars.
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 8.01 Other Events.
On February 14, 2024, NeuroBo Pharmaceuticals, Inc. (the “Company”) posted an updated corporate presentation to its website at https://www.neurobopharma.com/events-presentations/presentations, which the Company may use from time to time in communications or conferences. A copy of the corporate presentation is attached as Exhibit 99.1 to this Current Report on Form 8-K (this “Report”).
The information in this Report, including Exhibit 99.1 hereto, is furnished pursuant to Item 7.01 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 a filing. The Company’s submission of this Report shall not be deemed an admission as to the materiality of any information required to be disclosed solely to satisfy the requirements of Regulation FD.
Exhibit 99.1 hereto contains forward-looking statements within the meaning of the federal securities laws. These forward-looking statements are based on current expectations and are not guarantees of future performance. Further, the forward-looking statements are subject to the limitations listed in Exhibit 99.1 and in the other reports of the Company filed with the Securities and Exchange Commission, including that actual events or results may differ materially from those in the forward-looking statements.
Item 9.01.Financial Statements and Exhibits.
(d) Exhibits
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| Exhibit<br>Number | Exhibit Description | |
| 99.1 | | Corporate Presentation, dated February 2024 |
| 104 | | Cover Page Interactive Data File (embedded within Inline XBRL document). |
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.
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| | NOBO PHARMACEUTICALS, INC. | |
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| Date: February 14, 2024 | | By: |
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All values are in Euros.
Exhibit 99.1
| December 2023<br>NASDAQ: NRBO 1<br>February 2024<br>NeuroBo<br>Pharmaceuticals, Inc. |
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| 2<br>Forward-Looking Statements<br>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<br>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<br>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<br>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<br>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<br>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<br>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<br>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<br>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<br>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<br>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;<br>whether we are able to regain 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<br>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,<br>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<br>ended December 31, 2022 and our other filings with the Securities and Exchange Commission.<br>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<br>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<br>representing our views as of any date subsequent to this presentation.<br>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<br>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<br>necessarily subject to a high degree of uncertainty and risk. |
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| 3<br>Strong Leadership Team<br>Management Team<br>Hyung Heon Kim, Chief Executive Officer<br>Robert Homolka, SVP Clinical Operations<br>Stephen Harrison, M.D., Consulting Chief Medical Officer<br>Sung-Jin Kim, Pharmacist, Director of Corporate Strategy<br>Mi-Kyung Kim, Ph.D., RPh, Chief Scientific Officer Marshall H. Woodworth, Acting Chief Financial Officer<br>▪ 20+ years of experience in M&A, financing and corporate governance<br>▪ 10+ years of licensing, M&A and compliance with Dong-A Group<br>▪ Former General Counsel/SVP at Dong-A ST and Dong-A Socio Group<br>▪ BA Soonghsil University, JD Washington University School of Law<br>▪ 25+ years in drug discovery research at Dong-A ST<br>▪ Specialized in diabetes, obesity, MASH, immune-mediated diseases<br>▪ Ph.D., RPh, College of Pharmacy, Ewha Womans University<br>▪ 35+ years in pharmaceutical and biotech development<br>▪ Sr. director of clinical operations in Adiso Therapeutics<br>▪ Director of clinical operations at Shire/Takeda pharmaceuticals<br>▪ Director of experimental trial management at AstraZeneca<br>▪ MASH/NAFLD clinical trials expert, ~300 peer reviewed publications<br>▪ Visiting Professor, Hepatology, Oxford University<br>▪ M.D. University of Mississippi<br>▪ Col (ret.) USA, MC<br>▪ 35+ years of financial experience<br>▪ 20+ years working with life science investors and analysts<br>▪ CFO of Nevakar Inc., Braeburn Pharmaceuticals Inc., Aerocrine AB and Furiex<br>Pharmaceuticals Inc.<br>▪ BS University of Maryland, MBA Indiana University<br>▪ 18+ years on pharmaceutical industry at Dong-A ST<br>▪ Team lead of corporate planning<br>▪ Study manager of clinical trials specialized in diabetes<br>▪ Manager of business development |
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| 4<br>Compelling Investment Opportunity<br>Targeting MASH and Obesity with a Pipeline of Next Generation Therapeutics<br>▪ Aiming to Increase Shareholder Value through Multiple, Near-Term, Value Creating Milestones<br>• DA-1241<br>✓ Open IND for Treatment of MASH and Type 2 Diabetes<br>✓ Actively recruiting into a Phase 2a for DA-1241 in subjects with presumed MASH<br>✓ Completed SAD and MAD studies (in healthy volunteers and subjects with T2D)<br>• DA-1726<br>✓Open IND for Treatment of Obesity<br>▪ Backed by Strategic Partner and Major Shareholder, Dong-A ST<br>▪ Well Capitalized With $25.8 million in Cash at the end of Q3 2023. Cash runway into Q4 2024<br>▪ Exploring Strategic Opportunities to Out-License legacy assets |
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| 5<br>Pipeline<br>Asset Preclinical Phase 1<br>Phase 2<br>DA-1241<br>(GPR119 Agonist)<br>DA-1726<br>(GLP1R/GCGR<br>Dual Agonist)<br>2a 2b<br>OBESITY<br>Indication Phase 3<br>MASH<br>Obesity |
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| 6<br>Multiple Near-Term Milestones:<br>Targeting to Increase Shareholder Value<br>Investments in the current DA-1241 Phase 2a and planned DA-1726 Phase 1 have the<br>potential for significant returns in the event of clinical and regulatory success<br>H1 2025<br>Meeting with<br>FDA<br>2024 2025<br>H2 2025<br>Phase 2b Protocol<br>Submission<br>DA-1241 Q3 2024<br>Phase 2a<br>Last Patient Last Visit<br>Q4 2024<br>Phase 2a<br>Top Line Results<br> Q1 2024<br>Phase 1<br>IND No Objections<br>DA-1726<br>H1 2025<br>Phase 1 (Part 1)<br>Last Patient Visit<br>H1 2024<br>Phase 1 (Part 1)<br>First Patient In<br>H2 2024<br>Phase 1 (Part 2) First Patient In<br>H1 2025<br>Phase 1 (Part 1)<br>Top Line Results<br>H2 2025<br>Phase 1 (Part 2)<br>Top Line Results<br>H2 2025<br>Phase 1 (Part 2)<br>Last Patient Visit<br>* These milestones assume regulatory and clinical success, which is not guaranteed |
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| December 2023<br>NASDAQ: NRBO 7<br>DA-1241<br>Orally Available, Potential<br>First-in-Class GPR119 Agonist for<br>the Treatment of MASH |
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| 8<br>DA-1241: Competitive Differentiation<br>1. https://ir.madrigalpharma.com/news-releases/news-release-details/madrigal-announces-positive-topline-results-pivotal-phase-3<br>Resmetirom DA-1241<br>Developer Madrigal NeuroBo<br>Indication MASH MASH<br>Status Phase 3 completed<br>NDA Submitted Phase 2<br>Action THR (Thyroid hormone receptor) β agonist GPR119 agonist<br>Dosage Once daily, oral Once daily, oral<br>Efficacy<br>in Human<br>MASH resolution with more than a 2-point reduction in MASH Activity<br>Score (100mg: 30%, 80mg: 26%, Placebo: 10%)(1)<br>Effective in treating or modifying the progression of MASH, NAFLD<br>Activity Score and Biomarkers<br>Safety in Human Mild/transient diarrhea, mild nausea(1) Headache, somnolence, fatigue, hypoglycemia, and cold sweat<br>(reported in Phase I studies)<br>Differentiation If approved by the NDA, the first treatment for MASH<br>1. Unique mechanism of action. Works on inflammation<br>associated with MASH<br>2. Can be used as a monotherapy or in combination with<br>other therapies<br>3. Synergistic effect(s) when co-administered with a DPP4<br>or GLP1R agonist |
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| 9<br>DA-1241 Effect on Pathogenesis in MASH as a Monotherapy<br>GPR119 activation:<br>Monocytes and macrophages<br>▪ Macrophage activation<br>▪ Monocyte recruitment<br>▪ Macrophage differentiation<br>→ Reduction in hepatic and systemic inflammation<br>Hepatic stellate cells<br>Stellate cell activation<br>→ Reduce hepatic fibrogenesis<br>Hepatocytes and intestinal L-cells<br>De novo lipogenesis<br>Dietary fat absorption<br>→ Reduce hepatic steatosis<br>Steatosis Steatohepatitis Fibrosis<br>DAMPs: danger-associated molecular patterns<br>PAMPs: pathogen-associated molecular patterns<br>ECM: extracellular matrix |
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| 10<br>GPR119 in Glucose Control when Co-Administered<br>with Other Therapies<br>▪ Effectively decreased hepatic inflammation<br>▪ Reduced systemic inflammation and fibrosis biomarkers<br>▪ Reduced hepatic lipid and collagen deposition in the liver<br>of MASH mice<br>Activation of GLP1 Receptor Effects<br>▪ Pancreas<br>• Increase proliferation of beta cells<br>• Prevent the apoptosis of beta cells<br>• Increase insulin biosynthesis<br>• Increase insulin secretion<br>• Increase insulin biosynthesis<br>Liver effect<br>Pancreas effect<br>Intestine<br>Active GLP1<br>Inactive GLP1<br>DPP4 Inhibitor<br>+<br>-<br>GLP1R Agonists<br>GLP1<br>receptor<br>Stomach effect<br>Brain<br>Food ingestion<br>Changes of 22 stellate cell<br>activation-related genes<br>Changes of 17 inflammation signaling-related genes<br>▪ Liver<br>• Decrease glucose<br>production<br>▪ Stomach<br>• Decrease gastric emptying<br>▪ Brain<br>• Decrease appetite |
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| 11<br>DA-1241: Differentiated Anti-Inflammatory Effect in<br>MASH Mice (1-3)<br>▪ DA-1241 was shown to improve BOTH hepatic and systemic inflammation effectively<br>▪ Co-administered with a DDD4 potentiated the anti-inflammatory effect<br>38<br>100<br>84<br>68 58<br>103<br>0<br>20<br>40<br>60<br>80<br>100<br>120<br>Change in Plasma Inflammatory Cytokine & Chemokines after 8-week<br>treatment in DIO-MASH mice (2,3)<br>CCL2 (%)<br>27<br>100<br>58 68<br>44<br>91<br>0<br>20<br>40<br>60<br>80<br>100<br>120<br>TNFα (%)<br>40<br>100<br>77 75<br>51<br>94<br>0<br>20<br>40<br>60<br>80<br>100<br>120<br>CXCL10 (%)<br>1.2<br>4.5<br>3.0<br>2.5 2.1<br>3.9<br>0<br>1<br>2<br>3<br>4<br>5<br>Galectin-3-positive area<br>(%)<br>Notes: GPR119 (G Protein-Coupled Receptor 119); MASH (Non-Alcoholic Steatohepatitis); GLP-1 (Glucagon-Like Peptide 1); DA-1241 (L), 30 mg/kg/day; DA-1241 (H), 100 mg/kg/day; Elafibranor (PPARα/δ agonist with anti-inflammatory effects; discontinued in Phase 3 for MASH); Sitagliptin (JANUVIATM, approved DPP4 inhibitor for T2DM)<br>1. Dong-A Study Report 103420<br>2. Dong-A Study Report 104458<br>3. Park H et al. 80th Scientific Session of American Diabetes Association, 2020, Poster presentation 216-LB<br>Change in Hepatic Immune Cell Infiltration<br>after 8-week treatment in DIO-MASH mice (1,3)<br>0.0<br>2.4<br>1.7 1.8<br>1.2<br>1.7<br>0<br>1<br>2<br>3<br>Inflammation score |
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| 12<br>Combo: Synergistic Effects with a DPP4 Inhibitor<br>in DIO-MSH Mice<br>▪ Increased plasma active GLP-1 in<br>DIO-MASH mice<br>▪ Augmented improvement<br>in steatosis, inflammation,<br>and fibrosis compared to<br>monotherapy<br>▪ Inhibited stellate cell activation<br>(αSMA+ area) further in the liver<br>▪ Improved Fibrosis-related<br>biomarkers (PINP and TIMP-1) in<br>plasma accordingly<br>C57BL/6 mice<br>12 weeks<br>Western diet<br>w/ or w/o each drug<br>30 weeks<br>Pre-biopsy<br>(-3w)<br>Post-biopsy<br>(after 12w)<br>Western diet<br>Liver Histology<br>Plasma Fibrosis Markers Liver Damage Markers<br>Kim MK et al., Biomed Pharmacother. 2023 Oct;166:115345. |
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| 13<br>DA-1241: Ongoing Phase 2a in MASH<br>Support use as a monotherapy<br>Study Design<br>Study Overview ▪ A multicenter, randomized, double-blind, placebo-controlled, parallel, Phase 2a clinical trial to evaluate the<br>efficacy and safety of DA-1241 in subjects with presumed non-alcoholic steatohepatitis<br>Primary Endpoint ▪ ALT change from baseline in alanine transaminase<br>Study Design<br>▪ 2 Part study<br>• Part 1: DA-1241 50mg, DA-1241 100mg, Placebo<br>• Part 2: DA-1241 100mg + Sitagliptin 100mg, Placebo<br>No. of Subjects ▪ Approximately 90 subjects with presumed MASH<br>Location ▪ Approximately 25 centers in the United States<br>Enrollment (planned) ▪ FPI August 2023<br>▪ LPLV June 2024<br>▪ DA-1241 modified the progression of MASH in Ob-MASH mice<br>▪ Exploring improved biomarkers (CCL2, TNFa, and TIMP1), liver fat content,<br>and stiffness as measured by Fibroscan and MRI<br>Exploring Co-Administration with a DPP4 inhibitor<br>▪ Identify ability to effectively decreased hepatic inflammation<br>▪ Explore ability to reduce systemic inflammation and fibrosis biomarkers<br>▪ Reduced hepatic lipid and collagen deposition in Ob-MASH mice<br>Notes: FPFV (First Patient First Visit); LPO (Last Patient Last Visit) |
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| 14<br>DA-1241: Potential Advantages in MASH<br>DA-1241 Potential<br>Advantages in MASH<br>▪ GPR119 therapeutic target<br>is to inhibit steatosis,<br>inflammation and fibrosis<br>and the treatment or progression<br>of MASH<br>▪ DA-1241 is an advanced GPR119<br>agonist with<br>proven enhanced efficacy<br>in animal models<br>▪ Its effect is enhanced<br>when combined with<br>a DPP4 inhibitor<br>• Inhibit fatty acid<br>biosynthesis in the liver<br>• Inhibit post-prandial<br>TG/CHO absorption<br>• Promote lipophagy<br>• Stimulate insulin and<br>GLP-1 secretion<br>• Inhibit gluconeogenesis<br>in the liver<br>• Protect beta cell death<br>from ER stress<br>• Inhibit macrophage<br>differentiation<br>• Inhibit inflammasome<br>activation caused by<br>PAMPs/DAMPs<br>• Inhibit hepatic stellate cell<br>activation by blocking<br>TGFβ signaling |
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| December 2023<br>NASDAQ: NRBO 15<br>DA<br>-1726<br>A Novel GLP1R/GCGR<br>Dual Agonist for the<br>Treatment of Obesity |
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| 16<br>DA-1726: Competitive Differentiation<br>Survodutide Mazdutide DA-1726 Semaglutide Tirzepatide<br>Developer Boehringer Ingelheim Innovent Biologics<br>Lilly NeuroBo Novo Nordisk Lilly<br>Indication Obesity Obesity Obesity Obesity Obesity<br>Status Phase 2 completed Phase 3 (China)<br>Phase 1 (USA) Phase 1 Initiation 1H 2024 Marketed (Obesity/Wegovy®)<br>Marketed (T2D/Ozempic®)<br>Marketed (Obesity/Zepbound®)<br>Marketed (T2D/Mounjaro®)<br>Action<br>Glucagon/GLP-1<br>receptor dual<br>agonist<br>Glucagon/GLP-1<br>receptor dual<br>agonist<br>Dual Agonist: GLP-1R<br>(Glucagon-Like Peptide 1 receptor),<br>GCGR (Glucagon receptor)<br>dual agonist<br>GLP-1R(Glucagon-like peptide-1 receptor) agonist<br>GLP-1R(Glucagon-like peptide-1<br>receptor) & GIPR(Glucose-dependent insulinotropic<br>polypeptide receptor) dual<br>agonist<br>Dosage Survodutide 4.8mg,<br>once weekly, injection<br>Mazdutide 9mg,<br>once weekly, injection<br>Exploratory dosing<br>in Phase 1<br>Semaglutide 2.4mg,<br>once weekly, injection<br>Tirzepatide 15mg,<br>once weekly, injection<br>Efficacy in Human Body weight loss,<br>16.7% @ 46-week<br>Body weight loss,<br>15.4% @ 24-week<br>(interim analysis)<br>Exploratory efficacy<br>in Phase 1<br>Body weight loss,<br>12.4% @ 68-week<br>Body weight loss,<br>20.1% @ 72-week<br>Safety in Human<br>Nausea, vomiting, diarrhea,<br>constipation,<br>Treatment discontinuations due<br>to AEs: 28.6%<br>Nausea, diarrhea, vomiting,<br>abdominal distension<br>Exploratory safety<br>in Phase 1<br>Nausea, diarrhea,<br>vomiting, constipation,<br>abdominal pain<br>Nausea, diarrhea,<br>decreased appetite, vomiting,<br>constipation<br>Differentiation<br>First-in-class for obesity,<br>Not reached plateau<br>at week 46<br>No discontinued treatment due<br>to adverse events in interim<br>analysis<br>• Weight loss similar or better as<br>compared to semaglutide<br>• Better tolerability due to balance<br>approach as compared to<br>semaglutide<br>In clinical preparation for 7.2<br>mg dose in obesity and T2D<br>patients; In recruiting<br>participants for MASH P3<br>Higher efficacy |
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| 17<br>DA-1726: Mechanism of Action<br>DA-1726 is a novel oxyntomodulin analogue functioning as a GLP1R/GCGR dual agonist for the<br>treatment of obesity<br>Notes: GLP1R/GCGR (Glucagon-Like Peptide 1 Receptor/Glucagon Receptor);<br>GLP-1 (Glucagon-Like Peptide 1)<br>1. Pocai A. Mol Metab.2014;3:241-51<br>▪ Oxyntomodulin<br>• a gut hormone released from intestinal<br>L-cells after meal ingestion resulting in dual<br>agonism of the GLP-1 receptor and glucagon<br>receptor<br>▪ Reduces food intake (GLP-1 R) and increases<br>energy expenditure (GCGR) in humans,<br>potentially resulting in superior body weight<br>lowering<br>Physiological effects of oxyntomodulin(1) |
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| 18<br>DA-1726: Therapeutic Potential in Obesity(1-3) —<br>Semaglutide Comparison<br>DA-1726 outperformed Semaglutide (WEGOVY ), a GLP-1 agonist, in mouse models<br>of obesity*<br>*Statistically significant compared to control<br>Notes: GLP1R/GCGR (Glucagon-Like Peptide 1 Receptor/ Glucagon Receptor); HF-DIO (High Fat-Diet Induced Obesity); GLP-1 (Glucagon-Like Peptide 1).<br>1. Dong-A Study Report 104561. All treatments given as twice weekly injections.<br>2. Dong-A Study Report 104455. All treatments given every 3 days as injections.<br>3. Kim TH et al. 82nd Meeting of the American Diabetes Association. 2022; Abstract 1403-P.<br>100.0%<br>72.1%<br>86.7% 80.2%<br>0.0%<br>20.0%<br>40.0%<br>60.0%<br>80.0%<br>100.0%<br>120.0%<br>Weight loss observed from DA-1726<br>is attributed to reduced food intake<br>via GLP1R and increased energy expenditure<br>via the GCGR<br>BWL in HF-DIO Obese Mice<br>DA-1726 vs Semaglutide (1,3)<br>% Change in BW from Baseline (Corrected to HF Control)<br>-30<br>-25<br>-20<br>-15<br>-10<br>-5<br>0<br>0 2 4 6 8 10 12 14 16 19 21 25 27<br>Treatment Day<br>High Fat Control Semaglutide (250 nmol/kg)*<br>DA-1726 (100 nmol/kg)* DA-1726 (200 nmol/kg)*<br>(16.3%)<br>(19.3%)<br>(26.8%)<br>BWL in HF-FATZO T2DM/Obese Mice<br>DA-1726 vs Semaglutide (2,3)<br>% Change in BW from Baseline (Corrected to HF Control)<br>-35<br>-30<br>-25<br>-20<br>-15<br>-10<br>-5<br>0<br>0 2 4 6 8 10 12 14 16 18 20 22 25<br>Treatment Day<br>High Fat Control Semaglutide (250 nmol/kg)*<br>DA-1726 (100 nmol/kg)* DA-1726 (250 nmol/kg)*<br>(12.5%)<br>(14.9%)<br>(25.4%)<br>Cumulative Food intake in<br>HF-DIO Obese Mice DA-1726<br>vs Semaglutide (1,3) |
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| 19<br>DA-1726: Therapeutic Potential in Obesity (1,2) —<br>Tirzepatide Comparison<br>DA-1726 shows similar weight loss while consuming more food compared to Tirzepatide (Mounjaro )<br>Notes: HF-DIO (High Fat-Diet Induced Obesity); BWL (Body Weight Loss)<br>1. Dong-A Study Report 105497. All treatments given as twice weekly injections.<br>2. Jung I-H et al. 83rd Meeting of the American Diabetes Association. 2023; Abstract 1668-P.<br>Weight loss is attributed to reduced food intake and increased energy expenditure<br>Cumulative Food intake in HF-DIO<br>Obese Mice DA-1726 vs Tirzepatide (1,2)<br>Plasma Biochemistry Analysis<br>DA-1726 vs Tirzepatide (1,2)<br>-40<br>-35<br>-30<br>-25<br>-20<br>-15<br>-10<br>-5<br>0<br>0 4 6 8 12 14 18 20 22 26<br>Treatment Day<br>High Fat Control<br>Tirzepatide (50 nmol/kg)*<br>Tirzepatide (100 nmol/kg)*<br>DA-1726 (100 nmol/kg)*<br>DA-1726 (200 nmol/kg)*<br>100.0%<br>69.0%<br>58.0%<br>89.3%<br>78.4%<br>0.0%<br>20.0%<br>40.0%<br>60.0%<br>80.0%<br>100.0%<br>120.0%<br>High Fat<br>Control<br>Tirzepatide<br>50<br>nmol/kg*<br>Tirzepatide<br>100<br>nmol/kg*<br>DA-1726<br>100<br>nmol/kg*<br>DA-1726<br>200<br>nmol/kg<br>*<br>*<br>*<br>*<br>*<br>*<br>*<br>*<br>*<br>*<br>*<br>*<br>*<br>* *<br>0.0%<br>20.0%<br>40.0%<br>60.0%<br>80.0%<br>100.0%<br>120.0%<br>ALT AST T-BIL GLU T-CHO TG<br>High Fat Control Tirzepatide<br>50 nmol/kg<br>Tirzepatide<br>100 nmol/kg<br>DA-1726<br>100 nmol/kg<br>DA-1726<br>200 nmol/kg<br>BWL in HF-DIO Obese Mice<br>DA-1726 vs Tirzepatide (1,2) |
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| 20<br>DA-1726: Phase 1 Study to Evaluate PK/PD and Safety<br>Rationale for study<br>▪ Gain a robust understanding of safety, tolerability of various dose levels in humans.<br>▪ Superior weight loss compared with the pair-fed group, indicating much of the weight loss was attributed to reduced food intake via activation of GLP-1<br>▪ Superior to both the pair-fed and control groups in energy expenditure (secondary to glucagon activation)<br>▪ Potentially superior weight loss compared to approved obesity products<br>Notes: MAD (Multiple Ascending Dose); SAD (Single Ascending Dose); PK (Pharmacokinetic); PD (Pharmacodynamic);<br> FPFV (First Patient First Visit); LPLV (Last Patient Last Visit).<br>Phase I<br>Study overview<br>▪ 2-part study<br>• Part 1—Single ascending dose study<br>• Part 2—Multiple ascending dose study<br>Population ▪ Obese otherwise healthy<br>No. of Subjects ▪ Approximately 100 subjects for both studies<br>Location ▪ United States |
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| December 2023<br>NASDAQ: NRBO 21<br>Financials<br>and<br>Capitalization |
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| 22<br>Cash Balance and Capitalization Table<br>Cash Balance As of September 30, 2023<br>Cash $25.8 million<br>Debt none<br>Capitalization Table as of December 31, 2023 Common Stock Equivalents<br>Common Stock 4,906,032<br>Warrants (WAEP $145.54)(1) 203,914<br>Options (WAEP $398.30) 4,700<br>Common Stock Shares Available for Issuance under Equity Incentive Plans 469,936<br>Fully Diluted 5,584,582<br>1. No ratchets, price resets or anti-dilution provisions. Presumes $0.00 exercise price for each Series B warrant exchangeable for one share of common stock. |
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| 23<br>Multiple Near-Term Milestones:<br>Targeting to Increase Shareholder Value<br>Investments in the current DA-1241 Phase 2a and planned DA-1726 Phase 1 have the<br>potential for significant returns in the event of clinical and regulatory success<br>H1 2025<br>Meeting with<br>FDA<br>2024 2025<br>H2 2025<br>Phase 2b Protocol<br>Submission<br>DA-1241 Q3 2024<br>Phase 2a<br>Last Patient Last Visit<br>Q4 2024<br>Phase 2a<br>Top Line Results<br> Q1 2024<br>Phase 1<br>IND No Objections<br>DA-1726<br>H1 2025<br>Phase 1 (Part 1)<br>Last Patient Visit<br>H1 2024<br>Phase 1 (Part 1)<br>First Patient In<br>H2 2024<br>Phase 1 (Part 2) First Patient In<br>H1 2025<br>Phase 1 (Part 1)<br>Top Line Results<br>H2 2025<br>Phase 1 (Part 2)<br>Top Line Results<br>H2 2025<br>Phase 1 (Part 2)<br>Last Patient Visit<br>* These milestones assume regulatory and clinical success, which is not guaranteed |
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| December 2023<br>NASDAQ: NRBO 24<br>Investment<br>Thesis |
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| 25<br>Compelling Investment Opportunity<br>Targeting MASH and Obesity with a Pipeline of Next Generation Therapeutics<br>▪ Aiming to Increase Shareholder Value through Multiple, Near-Term, Value Creating Milestones<br>• DA-1241<br>✓ Open IND for Treatment of MASH and Type 2 Diabetes<br>✓ Actively recruiting into a Phase 2a for DA-1241 in subjects with presumed MASH<br>✓ Completed SAD and MAD studies (in healthy volunteers and subjects with T2D)<br>• DA-1726<br>✓Open IND for Treatment of Obesity<br>▪ Backed by Strategic Partner and Major Shareholder, Dong-A ST<br>▪ Well Capitalized With $25.8 million in Cash at the end of Q3 2023. Cash runway into Q4 2024<br>▪ Exploring Strategic Opportunities to Out-License legacy assets |
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| December 2023<br>NASDAQ: NRBO 26<br>Thank You!<br>Investor Contacts:<br>Rx Communications Group<br>Michael Miller<br>+1 917.633.6086<br>mmiller@rxir.com<br>NeuroBo Pharmaceuticals<br>Marshall Woodworth<br>+1 919.749.8748<br>marshall.woodworth@neurobopharma.com |
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