8-K
MetaVia Inc. (MTVA)
8-K
2023-09-22
For: 2023-09-22
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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): September 22, 2023
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 of incorporation) | (Commission File Number) | (IRS Employer 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>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 7.01. Regulation FD Disclosure.
On September 22, 2023, 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.
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| (d) | Exhibits |
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| Exhibit Number | Exhibit Description | |
| 99.1 | Corporate Presentation, dated September 2023 | |
| 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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| | NeuroBo Pharmaceuticals, Inc. | |
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| Date: September 22, 2023 | By: | /s/ Hyung Heon Kim |
| | Hyung Heon Kim | |
| | | President and Chief Executive Officer |
Exhibit 99.1
| NeuroBo Pharmaceuticals, Inc.<br>NASDAQ: NRBO<br>September 2023 |
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| 0.66” 0.66”<br>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<br>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 "may,—will," "expect,"<br>"project," "estimate," "anticipate," "plan," "believe," "potential," "should,—continue,—could," "intend," "target," "predict," or the negative versions of those<br>words or other comparable words or expressions, although not all forward-looking statements contain these identifying words or expressions. Forward-looking statements are not guarantees of future actions or performance. These forward-looking statements include statements regarding the market size<br>and potential growth opportunities of NeuroBo’s current and future product candidates, capital requirements and use of proceeds, clinical development<br>activities, the timeline for, and results of, clinical trials, regulatory submissions, and potential regulatory approval and commercialization of its current and<br>future product candidates; executing on our commercial strategy, the realization of the benefits of the license agreement with Dong-A ST Co. Ltd., including<br>the impact on future financial and operating results of NeuroBo; the cooperation of our contract manufacturers, clinical study partners and others involved in<br>the development of our current and future product candidates; initiating and completing clinical trials on a timely basis; recruiting subjects for our clinical<br>trials; receiving results from our clinical trials that are consistent with the results of pre-clinical and previous clinical trials ;costs related to the license<br>agreement, known and unknown, including costs of any litigation or regulatory actions relating to the license agreement and applicable laws or regulations.<br>These forward-looking statements are based on information currently available to NeuroBo and its current plans or expectations and are subject to a<br>number of known and unknown uncertainties, risks and other important factors that may cause our actual results, performance or achievements expressed<br>or implied by the forward-looking statements. These and other important factors are described in detail in the "Risk Factors" section of NeuroBo's Annual<br>Report on Form 10-K for the year ended December 31, 2022, and NeuroBo's 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,<br>even if subsequent events cause our views to change. Although we believe the expectations reflected in such forward-looking statements are reasonable,<br>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<br>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<br>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,<br>projections, assumptions and estimates of our future performance and the future performance of the markets in which we operate are necessarily subject to<br>a high degree of uncertainty and risk. |
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| 0.66” 0.66”<br>3<br>Company is Reborn<br>November 2022<br>• Licensed DA-1241 (GPR119)<br>and DA-1726 (GLP1R/GCGR)<br>• New focus: NASH and<br>obesity<br>• IND for DA-1241 Phase 2<br>filed and cleared by FDA<br>Executing on Milestones<br>• Initiation of DA-1241<br>Phase 2a clinical<br>study<br>• IND for DA-1726<br>Value<br>Drivers in 2023<br>• Invested $15 million<br>• Largest shareholder<br>• NeuroBo has access to R&D,<br>scientific, CMC expertise<br>Dong-A is a Robust Partner<br>Transformed Company: Compelling<br>Investment Opportunity<br>➢ Transformed Company Through Licensing of Next Generation Cardiometabolic Assets<br>Targeting Large NASH and Obesity Markets<br>➢ Well Capitalized Into 2024 ($28.9 million as of June 30, 2023)<br>➢ Multiple Near-Term Value Creating Milestones to Drive Shareholder Value |
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| 0.66” 0.66”<br>4<br>Committed Partner Provides Financial and<br>R&D Support<br>Dong-A Socio Group<br>Revenue: $1.8B in 2022<br>Revenue $470M in 2022<br>Our strategic partner and largest shareholder, Dong-A ST Co. Ltd.,<br>is part of Dong-A Socio Group of companies established in 1932<br>and based in South Korea. The company has the full support of<br>Dong-A ST’s R&D resources and Research Center which was<br>established in 1977 as the first pharmaceutical research center in<br>Korea.<br>DONG-A ST<br>Dong-A ST<br>Dong-A ST Co., Ltd. develops, manufactures, and markets<br>pharmaceutical products and medical devices worldwide. It<br>offers various ethical drugs, including Stillen for the treatment of<br>gastritis; Zydena for erectile dysfunction treatment; Motilitone for<br>use in functional dyspepsia treatment; Sivextro an oxazolidinone<br>class antibiotic; and Suganon for diabetes treatment.<br>Dong-A Socio Holdings has been the leading<br>pharmaceutical company in South Korea with its<br>business focus in developing, manufacturing and<br>distributing innovative products for the healthier life of<br>their society. |
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| 0.66” 0.66”<br>5<br>Focused on Chronic Liver and Related<br>Metabolic Diseases<br>Product Preclinical Phase 1<br>Phase 2 Upcoming Catalysts<br>DA-1241<br>(GPR119 Agonist)<br>• 2H 2023: initiation of Part 2 of<br>Phase 2a in NASH<br>• 2H 2024: Phase 2a NASH data<br>readout<br>DA-1726<br>(GLP1R/GCGR Dual Agonist)<br>• 2H 2023: Phase 1 IND<br>submission<br>• 1H 2024: Phase 1a data readout<br>Completed Planned<br>2a 2b<br>OBESITY<br>NASH<br>Ongoing |
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| 0.66” 0.66”<br>6<br>Multiple Near-Term Milestones: Driving<br>Shareholder Value<br>2023 2024<br>1Q 2023 √<br>Phase 2a IND<br>submitted and cleared<br>2H 2023<br>Phase 1<br>IND submission<br>2H 2024<br>Phase 1b<br>data readout<br>2H 2024<br>Phase 2a<br>NASH data readout<br>DA-1726<br>DA-1241<br>1H 2024<br>Phase 2a<br>Last patient last visit<br>3Q 2023 √<br>Phase 2a<br>First patient in<br>1H 2024<br>Phase 1a<br>data readout<br>Corporate Opportunistic<br>strategic partnerships<br>Strategic divestiture<br>Legacy assets<br>The dates listed above are indicative only and are subject to receipt of FDA approval and enrollment into clinical trials, and delays of which may result in changes to the timing of the milestones set forth above.<br>Investments in the current DA-1241 Phase 2a and planned DA-1726 Phase 1 have the<br>potential for outsized returns in the event of clinical success |
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| DA-1241<br>Orally Available, Potential First-in-Class GPR119 Agonist<br>for the Treatment of NASH |
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| 0.66” 0.66”<br>8<br>DA-1241: A Unique Mechanism of Action<br>DA-1241 is a novel chemical entity activating G protein-coupled receptor 119 (GPR119)<br>with clinically confirmed glucose-lowering activity & inflammation reduction<br>➢ GPR119 activation in hepatocytes, macrophages, and hepatic<br>stellate cells inhibits lipid accumulation, immune cell infiltration,<br>and the production of collagen fibers in the liver, directly<br>ameliorating NASH pathophysiology such as steatosis,<br>inflammation, and fibrosis.<br>(1,2)<br>➢ DA-1241 effectively reduces BOTH hepatic and systemic<br>inflammation in mice with NASH. (3)<br>➢ In T2D patients in the Phase 1b clinical trial, advanced clinical<br>efficacy of DA-1241 monotherapy was successfully<br>confirmed compared to previous GPR119 products which<br>ceased development.<br>Notes: GPR119 (G Protein-Coupled Receptor 119); NASH (Non-Alcoholic Steatohepatitis); GLP-1 (Glucagon-Like Peptide 1);<br>1. Dong-A Study Report 104458.<br>2. Park H et al. 80th Scientific Session of American Diabetes Association. 2020; Poster presentation 217-LB.<br>3. Park H et al. 80th Scientific Session of American Diabetes Association, 2020, Poster presentation 216-LB |
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| 0.66” 0.66”<br>9<br>DA-1241: Direct Effect on Innate Immune<br>Cells Versus Current NASH Landscape<br>The Highlights of DA-1241’s Anti-NASH Effects<br>GPR119<br>GPR119<br>GPR119<br>DA-1421<br>Efruxifermin<br>Lanifibranor<br>Resmetirom<br>Notes: TG (triglycerides); LDL-C (low density lipoprotein cholesterol); HDL-C (high density lipoprotein cholesterol); TNF (tumor necrosis factor CCL (CC motif chemokine ligand); CXCL (C※C motif chemokine ligand); FGF (fibrosis growth factor); PPAR (peroxisome proliferator-activated<br>receptor); THR-B (thyroid hormone receptor beta)<br>1. Adopted and modified from Clinical Gastroenterology and Hepatology, 2023;21(8):2001-2014<br>MoA of the main candidate drugs for NASH1<br>Hepatic effects<br>➢ Reduces immune cell infiltration into the liver by<br>inhibiting immune cell activation and differentiation<br>➢ Reduces collagen fiber deposition by inhibiting<br>hepatic stellate cell activation<br>➢ Reduces liver fat accumulation by inhibiting lipid<br>biosynthesis<br>Extrahepatic effects<br>➢ Reduces fasted and postprandial glucose levels in<br>humans<br>➢ Improve dyslipidemia (TG & LDL-C↓, HDL-C↑)<br>➢ Improve systemic inflammatory status such as TNF,<br>CCL2, CXCL1/2/10` |
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| 0.66” 0.66”<br>10<br>DA-1241: Differentiated Anti-Inflammatory<br>Effect (1-3) in NASH Mice<br>DA-1241 was shown to effectively improve BOTH hepatic and systemic inflammation<br>Combination with Sitagliptin potentiated the anti-inflammatory effect of DA-1241 monotherapy<br>38<br>100<br>84<br>68<br>58<br>103<br>0<br>20<br>40<br>60<br>80<br>100<br>120<br>Change in Plasma Inflammatory Cytokine & Chemokines<br>after 8-week treatment in DIO-NASH mice (2,3)<br>CCL2 (%)<br>27<br>100<br>58<br>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<br>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<br>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); NASH (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 NASH);<br>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-NASH 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<br>*Bold: p<0.05 vs. DIO-NASH |
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| 0.66” 0.66”<br>11<br>DA-1241: Pre-Clinical Highlights<br>DA-1241 Encouraging Pre-Clinical Findings<br>➢ DA-1241 has a higher intrinsic activity compared to preexisting GPR119 agonists<br>and triggers unique balanced signaling paths. Therefore, DA-1241 shows an<br>improved in vivo efficacy with sustained anti-diabetic effects<br>➢ DA-1241 improved steatosis, inflammation and fibrosis in various NASH mouse<br>models<br>➢ The combined use of DA-1241 and a DPP4 inhibitor augmented the anti-NASH<br>effect as well as anti-diabetic effect<br>➢ DA-1241 showed no noteworthy safety concerns in safety pharmacology and<br>toxicology studies up to 26 & 39-week chronic dosing in rats and dogs |
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| 0.66” 0.66”<br>12<br>Clinical Outcomes<br>Study<br>▪ Phase 1a, First-In-Human, Double-Blind, Placebo-Controlled, Randomized, Single Ascending Dose and<br>Interactions with Metformin Study (n=60)<br>▪ Phase Ib, Double-Blind, Placebo-Controlled, Randomized, Multiple Ascending Dose Study (n=108)<br>➢ Study treated 24 healthy volunteers for 28 days and 84 subjects with T2DM for 56 days<br>Safety/<br>PK<br>▪ Phase 1a, DA-1241 was well tolerated at doses up to 400 mg in healthy volunteers<br>▪ Phase 1b, DA-1241 was well tolerated at doses up to 200 mg/d for 28 days in healthy males and 100<br>mg/d for 56 days in T2DM subjects<br>▪ Once-daily oral administration of DA-1241 tablets showed sufficient clinical exposure, increasing in a<br>dose-dependent manner in T2DM subjects.<br>PD<br>Results<br>▪ DA-1241 was comparable to Sitagliptin (JANUVIATM) in post-prandial glucose reduction, suggesting<br>higher clinical efficacy than DS-8500a (Daiichi Sankyo’s GPR119 agonist; failed in Phase2b)<br>▪ Secretion of GIP, GLP-1 and PYY were increased at Day 56 in all DA-1241 treatment groups, consistent<br>with the mechanism of action of DA-1241<br>Notes: T2DM (Type 2 Diabetes Mellitus); PK (Pharmacokinetics); PD (Pharmacodynamic); AE (Adverse Event); iAUE (incremental Area Under the Measurement Versus Time Curve); GLP-1 (Glucagon-Like Peptide 1); GIP (Glucose-Dependent Insulinotropic Peptide); PYY (Polypeptide YY).<br>1. Dong-A Study Report DA1241_DM_Ia.<br>2. Dong-A Study Report DA1241_DM_Ib.<br>3. Kim MK et al. 81st Meeting of the American Diabetes Association. 2021; Abstract 765-P.<br>4. Kim MK et al. 81st Meeting of the American Diabetes Association. 2021; Abstract 766-P.<br>5. 12-Week Study of DS-8500a in Subjects With Type 2 Diabetes Mellitus on Metformin (NCT02647320)<br>34<br>18.5<br>-5.1<br>-38.6<br>-23.9<br>-45<br>-25<br>-5<br>15<br>35<br>55<br>Placebo DA-1241<br>25 mg<br>DA-1241<br>50 mg<br>DA-1241<br>100 mg<br>Sitagliptin<br>Change in Glucose iAUE0-4h in U.S. T2DM<br>Subjects at Day 56 (Week 8)<br>Confirmed enhanced efficacy of DA-1241: translation from non-clinical to clinical<br>-24.16<br>-18.77<br>13.81<br>-5.51<br>-60 -53.4<br>-50<br>-40<br>-30<br>-20<br>-10<br>0<br>10<br>20<br>Placebo DS-8500a<br>25 mg<br>DS-8500a<br>50 mg<br>DS-8500a<br>75 mg<br>Sitagliptin<br>Change in Glucose iAUE0-3h in U.S. T2DM<br>Subjects at Week 12 (5)<br>DA-1241 Clinical Proof-of-Concept<br>Phase 1 (1-4) |
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| 0.66” 0.66”<br>13<br>DA-1241: Ongoing Phase 2a in NASH<br>Notes: FPFV (First Patient First Visit); LPO (Last Patient Last Visit)<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: ▪ Change from baseline in alanine transaminase (ALT) levels at Week 16<br>No. of Subjects: ▪ A total of 87 subjects, with a planned maximum of 98 subjects to account for early discontinuations<br>Treatment Groups: ▪ 4 groups: DA-1241 50mg, DA-1241 100mg, DA-1241 100mg + Sitagliptin 100mg, Placebo<br>Location: ▪ Approximately 20 centers in the United States<br>Enrollment (planned): ▪ August 2023 ~ June 2024<br>▪ DA-1241 alleviated progression of NASH in Ob-NASH mice<br>on a high fat/fructose/CHO diet<br>▪ CCL2 and TIMP-1 and other biomarkers improved in both<br>plasma and liver<br>▪ Reduced hepatic lipid and collagen deposition in the liver<br>of NASH mice<br>▪ Effectively decreased hepatic inflammation<br>▪ Reduced systemic inflammation and fibrosis biomarkers<br>Rationale for NASH study as monotherapy Rationale for Combination with DPP4 inhibitor |
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| 0.66” 0.66”<br>14<br>DA-1241: Potential for Best-In-Class Efficacy<br>▪ Novel, first-in-class GPR119 agonist for<br>NASH<br>▪ Small molecule oral, once-daily<br>administration<br>▪ Multimodal mechanism<br>▪ Proven preclinical anti-NASH effects<br>▪ Positive effects in animals on hepatic steatosis,<br>fibrogenesis/fibrosis, hepatic & systemic inflammation, and NASH<br>progression<br>▪ Promise in multiple co-morbidities: NASH, T2DM, dyslipidemia<br>▪ Decreased risk of hypoglycemia<br>Promising Preclinical Efficacy In NASH<br>▪ Release of key peptides GLP-1, GIP, and PYY, which play a role in glucose & lipid metabolism, and weight loss<br>▪ Reduction of lipids, collagen deposition, and stellate cell activation<br>▪ Beneficial effects on blood glucose levels, as well as pro-inflammatory cytokines & chemokines<br>▪ Reversion of hepatic transcriptome toward normal control<br>GPR119 Agonism Has Positive Effect On |
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| 0.66” 0.66”<br>15<br>DA-1241: Competitive Analysis<br>Notes:<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 NASH NASH<br>Status Phase 3 completion<br>NDA Submitted Phase 2a IND approval<br>Action THR(Thyroid hormone receptor) β agonist GPR119 agonist<br>Dosage once daily, oral once daily, oral<br>Efficacy<br>in Human<br>1. NASH resolution with more than a 2-point reduction<br>in NAS<br>(100mg: 30%, 80mg: 26%, Placebo: 10%)<br>To explore efficacy for NASH in Phase 2a.<br>Confirmed comparable efficacy to Sitagliptin in Phase<br>1b for T2D, suggesting higher efficacy than DS-8500a.<br>Safety<br>in Human<br>1. mild/transient diarrhea, mild nausea To explore safety for NASH in Phase 2a<br>Differentiation If approved by the NDA, the first treatment for NASH Concomitant control of hyperglycemia |
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| DA-1726<br>A Novel GLP1R/GCGR Dual Agonist<br>for the Treatment of Obesity |
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| 0.66” 0.66”<br>17<br>DA-1726: Mechanism of Action<br>DA-1726 is a novel oxyntomodulin analogue functioning as a GLP1R/GCGR dual<br>agonist for the treatment of Obesity<br>➢ Oxyntomodulin is a gut hormone released from intestinal L-cells after meal ingestion and represents dual agonism of the<br>GLP-1 receptor and glucagon receptor<br>➢ DA-1726 reduces food intake (GLP-1 R) and increases<br>energy expenditure (GCGR) in humans, potentially resulting in<br>superior body weight lowering<br>➢ DA-1726 is well balance to have low risk for hyperglycemia<br>• While activation of GCGR increases glucose production<br>posing a hyperglycemic risk, the simultaneous activation of<br>GLP-1 receptor counteracts this effect<br>Notes: GLP1R/GCGR (Glucagon-Like Peptide 1 Receptor/ Glucagon Receptor); NASH (Non-Alcoholic Steatohepatitis); T2DM<br>(Type 2 Diabetes Mellitus); OXM (Oxyntomodulin); GLP-1 (Glucagon-Like Peptide 1).<br>1. Pocai A. Mol Metab.2014;3:241-51.<br>Physiological effects of oxyntomodulin (1) |
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| 0.66” 0.66”<br>18<br>5<br>7<br>9<br>11<br>13<br>15<br>17<br>19<br>21<br>6 12 18 24 30 36 42 48 54 60 66 72<br>Energy Expenditure (kcal/kg/hr)<br>Time (hours)<br>HF Control Pair-Fed DA-1726*#<br>DA-1726: Mechanism of Action of Body<br>Weight Loss (1,2)<br>▪ DA-1726 was superior to the pair-fed group in the body weight loss,<br>indicating that reduced food intake via activating GLP-1 receptor and<br>increase in energy expenditure, which is secondary to glucagon<br>activation<br>BWL in Obese Mice Cumulative Food Intake Energy Expenditure<br>4-week<br>HFD feeding s.c. injection, every 3 days<br>14-week<br>C57BL/6-DIO mouse 20-day<br>▪ Animals: male HF-DIO obese mice<br>▪ Regimen: Every three days S.C. injection<br>▪ DA-1726 Dose: 125 nmol/kg<br>58.1<br>41.6* 40.4*<br>0<br>20<br>40<br>60<br>80<br>HF Control DA-1726 Pair-Fed<br>(40)<br>(30)<br>(20)<br>(10)<br>0<br>10<br>0 3 6 9 12 15 18<br>Treatment Day<br>HF-Control Pair-Fed DA-1726<br>% Change in BW from Baseline (Corrected to HF Control) Energy Expenditure for 72 Hours (kcal/kg/hr)<br>Mean energy expenditure:<br>DA-1726*# 16.6 kcal/kg/hr<br>Pair-Fed 12.4 kcal/kg/hr<br>HF Control 12.6 kcal/kg/hr<br>(35.7%)<br>(15.9%)<br>#<br>*<br>Notes: HF-DIO (High Fat-Diet Induced Obesity); GLP-1 (Glucagon-Like Peptide 1); S.C. (Subcutaneous); HFD (High Fat Diet).<br>1. Dong-A Study Report 104372.<br>2. Kim TH et al. 82nd Meeting of the American Diabetes Association. 2022; Abstract 1403-P.<br>* Statistically significant compared to control # Statistically significant compared to either treatment |
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| 0.66” 0.66”<br>19<br>DA-1726 :Therapeutic Potential in<br>Obesity (1-3) – Semaglutide Comparison<br>DA-1726 out-performed Semaglutide (WEGOVY™), a GLP-1 agonist, in mouse<br>models of obesity<br>BWL in HF-DIO Obese Mice<br>DA-1726 vs Semaglutide (1,3)<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>*Statistically significant compared to control<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 HF-DIO Obese<br>Mice DA-1726 vs Semaglutide (1,3)<br>100.0%<br>72.1%<br>86.7%<br>80.2%<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>Semaglutide<br>250 nmol/kg*<br>DA-1726<br>100 nmol/kg<br>DA-1726<br>200 nmol/kg*<br>Weight loss observed from DA-1726 is attributed to<br>reduced food intake via GLP1R and increased energy<br>expenditure via the GCGR |
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| 0.66” 0.66”<br>20<br>DA-1726: Therapeutic Potential in<br>Obesity (1,2) – Tirzepatide Comparison<br>DA-1726 shows similar efficacy while consuming more food compared to Tirzepatide (Mounjaro™)<br>in mouse models of obesity and more effective in improving plasma metabolic parameters<br>Cumulative Food intake in HF-DIO Obese<br>Mice DA-1726 vs Tirzepatide (1,2)<br>BWL in HF-DIO Obese Mice<br>DA-1726 vs Tirzepatide (1,2)<br>Plasma Biochemistry Analysis<br>DA-1726 vs Tirzepatide (1,2)<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>-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 Tirzepatide (50 nmol/kg)*<br>Tirzepatide (100 nmol/kg)* 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 nmol/kg*<br>Tirzepatide<br>100<br>nmol/kg*<br>DA-1726<br>100<br>nmol/kg*<br>DA-1726<br>200 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 |
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| 0.66” 0.66”<br>21<br>GLP1R/GCGR dual agonist for the treatment of Obesity<br>A novel oxyntomodulin analogue, once-weekly subcutaneous administration<br>DA-1726: Pre-Clinical Highlights<br>• DA-1726 induces balanced activation between GLP-1 and glucagon receptors<br>• DA-1726 showed reduced food intake via activating GLP-1 receptor as well as energy expenditure<br>via glucagon activation<br>• In obese mouse, DA-1726 lost more weight than Semaglutide<br>• In obese mouse, DA-1726 lost similar weight while consuming more food than Tirzepatide<br>• Histopathology of DA-1726 showed further improvements in hepatic steatosis, inflammation, and<br>fibrosis compared to Semaglutide<br>• Balanced activation of GLP-1 and glucagon receptors potentially lowers the risk of hypoglycemia<br>and hyperglycemia |
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| 0.66” 0.66”<br>22<br>DA-1726 Planned Phase 1a to Evaluate<br>PK/PD and Safety in Obesity<br>Notes: MAD (Multiple Ascending Dose); SAD (Single Ascending Dose); PK (Pharmacokinetic); PD (Pharmacodynamic); FPFV (First Patient First Visit); LPLV (Last Patient Last Visit).<br>Phase I<br>Study overview: ▪ 12-week SAD/MAD, PK/PD, safety and tolerability; extended dosing (12 weeks) in Phase I1b<br>study with obese patients could provide an added clinical signal in obesity<br>Population: ▪ Phase 1a: healthy volunteers; Phase 1b mix of healthy volunteers and otherwise healthy obese<br>No. of Subjects: ▪ Approximately 100 subjects for both studies<br>Location: ▪ United States (consideration may be given to Australia)<br>Duration of Study: ▪ FPFV to topline results approximately 18 months (SAD & MAD combined)<br>▪ In animal models DA-1726 had superior weight loss compared with pair-fed group ,<br>indicating much of weight loss was attributed to reduced food intake via activation of GLP-1<br>▪ DA-1726 was also superior to both the pair-fed and control groups in energy expenditure<br>(secondary to glucagon activation)<br>▪ Potentially superior weight loss compared with Semaglutide<br>▪ Potential for similar weight loss while consuming more food than Tirzepatide<br>Rationale for Obesity study |
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| 0.66” 0.66”<br>23<br>DA-1726: Competitive Differentiation<br>Survodutide Mazdutide DA-1726 Semaglutide<br>(Wegovy®)<br>Tirzepatide<br>(Maunjaro®)<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 IND in 2H 2023 Marketed Phase 3 (Obesity)<br>Marketed (T2D)<br>Action<br>glucagon/GLP-1<br>receptor dual<br>agonist<br>glucagon/GLP-1<br>receptor dual<br>agonist<br>GLP-1R(Glucagon-Like<br>Peptide 1 receptor) &<br>GCGR(Glucagon receptor)<br>dual agonist<br>GLP-1R(Glucagon-like<br>peptide-1 receptor) agonist<br>GLP-1R(Glucagon-like<br>peptide-1 receptor) &<br>GIPR(Glucose-dependent<br>insulinotropic polypeptide<br>receptor) dual agonist<br>Dosage Survodutide 4.8mg,<br>once weekly, injection<br>Mazdutide 9mg,<br>once weekly, injection<br>To explore once weekly,<br>injection in Phase 1<br>Semaglutide 2.4mg,<br>once weekly, injection<br>Tirzepatide 15mg,<br>once weekly, injection<br>Efficacy<br>in Human<br>Body weight loss,<br>16.7% @ 46-week<br>Body weight loss,<br>15.4% @ 24-week<br>(interim analysis)<br>To explore efficacy in Phase<br>1b<br>Body weight loss,<br>12.4% @ 68-week<br>Body weight loss,<br>20.1% @ 72-week<br>Safety<br>in Human<br>nausea, vomiting, diarrhea,<br>constipation,<br>Treatment discontinuations<br>due to AEs: 28.6%<br>nausea, diarrhea, vomiting,<br>abdominal distension<br>To explore safety in Phase<br>1b<br>nausea, diarrhea, vomiting,<br>constipation, abdominal<br>pain<br>nausea, diarrhea,<br>decreased appetite,<br>vomiting, constipation<br>Differentiation<br>First-in-class for obesity,<br>Not reached plateau at<br>week 46<br>No discontinued treatment<br>due to adverse events in<br>interim analysis<br>Out-performed<br>Semaglutide and similar<br>efficacy to Tirzepatide in<br>preclinical studies<br>In clinical preparation for<br>7.2 mg dose in obesity and<br>T2D patients, In recruiting<br>participants for NASH P3<br>Higher efficacy |
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| Corporate Overview |
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| 0.66” 0.66”<br>25<br>Broad Intellectual Property Portfolio<br>DA-1241 DA-1726<br>U.S.<br>▪ One patent: both composition of matter<br>and process of making the composition<br>- Expected to expire in 2035*<br>▪ One U.S. non-provisional patent<br>application: both composition of matter<br>and use of the composition<br>▪ One U.S. patent: both composition of matter<br>and use of the composition<br>- Expected to expire in 2038*<br>▪ One U.S. non-provisional patent application:<br>both composition of matter and use of the<br>composition<br>▪ PCT application entered national phases in<br>October 2022<br>OUS<br>▪ 17 patents:<br>- Expected to expire between 2035 and<br>2039*<br>▪ 14 patent applications: composition of<br>matter and/or use of the composition<br>▪ 5 composition of matter patents:<br>- Expected to expire between 2038 and<br>2040*<br>▪ 8 patent applications: composition of matter<br>and/or use |
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| 0.66” 0.66”<br>26<br>Strong Leadership Team<br>Management Team<br>Hyung Heon Kim, Chief Executive Officer<br>▪ 35+ years on the pharmaceutical and biotech development<br>▪ Sr. director of clinical operations in Adiso therapeutics<br>▪ Director of clinical operations in Shire/Takeda pharmaceuticals<br>▪ Director of experimental trial management in AstraZeneca<br>Robert Homolka, SVP Clinical Operations<br>▪ Visiting Professor, Hepatology, Oxford University<br>▪ NASH/NAFLD clinical trials expert, ~300 peer reviewed publications<br>▪ MD University of Mississippi<br>▪ Col (ret.) USA, MC<br>Stephen Harrison, M.D., Consulting Medical Director<br>▪ 18+ years on pharmaceutical industry in Dong-A ST<br>▪ Team lead of corporate planning<br>▪ Study manager of clinical trials specialized in diabetes<br>▪ Manager of business development<br>Sung-Jin Kim, Pharmacist, Director of Corporate Strategy<br>▪ 35+ years of investment banking and C-Suite experience<br>▪ CFO of Pinetree Therapeutics, US Medical Innovations, Rotor Clip<br>▪ Investment Banking positions at Credit Suisse, Prudential Securities,<br>Chase, Citi<br>▪ BA Harvard University, MBA Columbia University<br>Bennett Goldstein, Financial Advisor<br>▪ 25+ years in drug discovery research in Dong-A ST<br>▪ Specialized in diabetes, obesity, NASH, immune-mediated diseases<br>▪ Ph.D, RPh, College of Pharmacy, Ewha Womans University<br>Mi-Kyung Kim, Ph.D, RPh, Chief Scientific Officer<br>▪ Bachelor’s degree in accounting from the George Washington<br>University and is a licensed CPA<br>Adam Perlish, CPA, Controller<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 |
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| 0.66” 0.66”<br>27<br>Experienced Board of Directors<br>▪ 20+ years in executive management, at various levels<br>▪ Executive Vice President and General Counsel at Medifast Inc.<br>▪ U.S. Army Veteran; direct-commissioned Judge Advocate in U.S. Army’s (JAG)<br>Corps.<br>▪ BS Bethune-Cookman University, J.D. North Carolina Central University<br>Jason Groves<br>▪ 30+ years of experience in the pharmaceutical and medical device industry<br>▪ Former Co-Chief Executive Officer, TherapeuticsMD<br>▪ BA State University of New York, MBA NYU Stern School of Business<br>Mark A. Glickman<br>▪ 35+ years of experience as C-suite executive and board member with public<br>and private companies<br>▪ Former Chairman at Ampex Corporation<br>▪ BA Yale, MBA Wharton School of Finance<br>D. Gordon Strickland - Chair of the Audit Committee<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>Hyung Heon Kim - NeuroBo President & CEO<br>▪ 30+ years of experience as senior executive with public and private companies<br>and private law practice<br>▪ Advisory Board for Olympusat, legal advisor to Current Health Inc. and Triage<br>Technologies, Inc.<br>▪ BA Dartmouth College, J.D. and MBA University of Virginia<br>Michael Salsbury – Chair of Compensation Committee<br>Andrew Koven - Chairman of the Board, Chair of Nominating and<br>Corporate Governance Committee<br>▪ 35+ years of experience as C-suite executive, board member and general<br>counsel for public and private pharmaceutical companies<br>▪ Lead Independent Director of Kala Pharmaceuticals, Inc.<br>▪ BA and LLB Dalhousie University, LLM Columbia University |
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| 0.66” 0.66”<br>28<br>Supported By Scientific Advisory Board<br>Scientific Advisory Board<br>▪ Prof. of Neurology, Harvard Medical School<br>▪ Director, Center for Autonomic and Peripheral Nerve<br>Disorders<br>▪ Boston, MA<br>Roy Freeman, MBChB<br>▪ Associate Prof. of Medicine, Colorado University School<br>of Medicine<br>▪ Division of Endocrinology, Metabolism and Diabetes<br>▪ Boulder, CO<br>Leigh Perreault, MD, FACE, FACP<br>▪ Associate Prof. of Medicine, Harvard Medical School<br>▪ Co-Director Center for Weight Management and<br>Wellness Brigham and Women’s Hospital<br>▪ Boston, MA<br>Caroline Apovian, MD, FACP, FTOS, DABOM<br>▪ University of California at San Diego<br>▪ Director, NAFLD Research Center, Director of Hepatology,<br>Professor of Medicine, Vice Chief, Division of<br>Gastroenterology<br>▪ San Diego, CA<br>Rohit Loomba, MD, MHSc |
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| 0.66” 0.66”<br>29<br>Financials and Capitalization Table<br>1. No ratchets, price resets or anti-dilution provisions. Presumes $0 exercise price for each warrant exchangeable for one share of common stock.<br>Financial<br>Overview<br>As of June 30, 2023<br>Cash $28.9 million<br>Debt none<br>Capitalization as of June 30, 2023 Common Stock<br>Equivalents<br>Common Stock 38,241,685<br>Warrants (WAEP $13.00)(1) 2,458,576<br>Options (WAEP $59.51) 40,272<br>Common Stock Shares Available for Issuance under Equity Incentive<br>Plans<br>5,087,821<br>Fully Diluted 45,828,254 |
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| 0.66” 0.66”<br>30<br>Compelling Investment Summary<br>Targeting NASH and Obesity With a Pipeline of Next Generation<br>Therapeutics<br>• Driving Shareholder Value though Multiple, Near-Term, Value Creating Milestones<br>✓ IND Submission for Phase 2a Trial of DA-1241 for the Treatment of NASH<br>✓ Initiation of Phase 2a for DA-1241 in NASH<br>• Submission of IND for DA-1726 in Obesity<br>• Backed by Financial and Clinical Partner, Dong-A ST<br>• Well Capitalized With $28.9 million in Cash at Q2 2023<br>• Exploring Strategic Opportunities to Out-License Legacy Assets |
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| THANK YOU!<br>INVESTOR CONTACT:<br>RX COMMUNICATIONS GROUP<br>MICHAEL MILLER<br>+1-917-633-6086<br>MMILLER@RXIR.COM |
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| Appendix |
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| 0.66” 0.66”<br>33<br>Opportunity and Challenge in NASH<br>Select NASH Comparables in Phase 2(3)<br>Company Drug Target Dev. Stage<br>Akero Efruxifermin FGF-21 Phase 2 ongoing<br>Altimmune Pemvidutide GLP-1 Phase 2b mid-2023<br>CytoDyn Leronlimab CCR5 Phase 2b planned<br>Galectin Belapectin Galectin-3 Phase 2b planned<br>NGM Pharm. MK-3655 β-Klotho/FGFR1c Phase 2b ended<br>Terns Pharm. TERN-501 THRβ Phase 2b/3 2024<br>Viking Therap. VK2809 THRβ Phase 2<br>▪ No FDA approved treatments for NASH<br>▪ Projected to grow to $160 billion by 2030(1)<br>▪ 60% increase in prevalence from 17 million to 27<br>million (2015-2030)(2)<br>[ Essential Requirement and Demand ]<br>high level of safety and proven effectiveness<br>(1) https://www.globenewswire.com/news-release/2023/04/14/2647029/0/en/Global-Non-alcoholic-Steatohepatitis-NASH-Market-to-Reach-160-7-Billion-by-2030.html<br>(2) Hepatology, Loomba, Sanyal, 2018 Jan;67(1):123-133. doi: 10.1002/hep.29466. Epub 2017 Dec 1.<br>(3) NASDAQ, company websites & investor presentations<br>GLOBAL NASH SALES 2022-2030(1) NASH Prevalence 2015-2030 (est.) (2) (est.) SELECT NASH COMPANIES COMPARABLES<br>Market Cap(3)<br>0<br>5<br>10<br>15<br>20<br>25<br>30<br>35<br>40<br>2015<br>2016<br>2017<br>2018<br>2019<br>2020<br>2021<br>2022<br>2023<br>2024<br>2025<br>2026<br>2027<br>2028<br>2029<br>2030<br>U.S. NASH Prevalence (millions)<br>0<br>25<br>50<br>75<br>100<br>125<br>150<br>175<br>200<br>2022<br>2023<br>2024<br>2025<br>2026<br>2027<br>2028<br>2029<br>2030<br>Global NASH Sales ($billions)<br>NRBO<br>GALT<br>ALT<br>CYDY<br>NGM<br>TERN<br>AKRO<br>VKTX<br>0<br>200<br>400<br>600<br>800<br>1,000<br>1,200<br>1,400<br>1,600<br>1,800<br>2,000<br>Market Cap ($millions) |
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| 0.66” 0.66”<br>34<br>Tangible Universe of Successful, Early-Stage Comparables in Obesity<br>Select Obesity Comparables in Phase 2<br>Company Drug Target Dev. Stage<br>Altimmune Pemvidutide GLP/GCGR Phase 2<br>Hanmi Pharmaceuticals Efinopegdutide GLP/GCGR Phase 2<br>Jiangsu Hansoh Noliglutide GLP1 analog Phase 2<br>Rhythm Setmelanotide MC4R agonist Phase 2<br>Viking VK2735 GLP1/GIP (agonist) Phase 1 completed<br>Zealand Pharma ZP6590 GIPR Preclinical<br>▪ Significant opportunity in obesity despite<br>crowded landscape<br>▪ The obesity market is projected to grow to $54<br>billion by 2030(1)<br>▪ By 2030, 49% of U.S. adults are expected to be<br>obese(2)<br>GLOBAL OBESITY SALES 2022-2030(1) (est.)<br>(1) https://www.morganstanley.com/ideas/obesity-drugs-investment-opportunity, accessed 4/26/2023<br>(2) https://www.latimes.com/science/story/2019-12-18/nearly-half-of-us-adults-will-be-obese-by-2030, accessed 4/20/2023<br>SELECT OBESITY COMPANY COMPARABLES Market Cap<br>($millioms)<br>U.S. OBESITY PREVALENCE 2022-2030(2) (est.)<br>0<br>25<br>50<br>75<br>100<br>125<br>150<br>175<br>200<br>2022<br>2023<br>2024<br>2025<br>2026<br>2027<br>2028<br>2029<br>2030<br>U.S. NASH Prevalence (millions)<br>0<br>10<br>20<br>30<br>40<br>50<br>60<br>70<br>2022<br>2023<br>2024<br>2025<br>2026<br>2027<br>2028<br>2029<br>2030<br>Global Obesity Sales ($billions)<br> -<br> 500<br> 1,000<br> 1,500<br> 2,000<br> 2,500<br>NRBO ALT Rhythm VKTX Hamni<br>Pharma<br>Zealand |
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