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): March 5, 2021
NeuroBo Pharmaceuticals, Inc.
(Exact name of Registrant as Specified in Its Charter)
| Delaware | 001-37809 | 47-2389984 |
|
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
200 Berkeley Street, Office 19th Floor
Boston, Massachusetts 02116
(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:
| ¨ | 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:
| Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered | ||
| Common Stock, par value $0.001 per share | NRBO | The Nasdaq Stock Market LLC |
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 x
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. x
Item 7.01 Regulation FD Disclosure.
Representatives of NeuroBo Pharmaceuticals, Inc. will be presenting the slides attached as Exhibit 99.1 to this report at the H.C. Wainwright Global Life Sciences Conference taking place virtually from March 9-10, 2021.
The information furnished pursuant to Item 7.01, including Exhibit 99.1, 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, and shall not be deemed to be 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 filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit | ||
| Number | Exhibit Description | |
| 99.1 | Company Presentation, dated March 5, 2021 |
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 thereunto duly authorized.
| NEUROBO PHARMACEUTICALS, INC. | ||
| Date: March 5, 2021 | By: | /s/ Richard Kang |
| Richard Kang | ||
| President and Chief Executive Officer | ||
Exhibit 99.1
Company Presentation Confidential March 2021
2 Disclaimers This presentation includes forward - looking statements within the meaning of Section 27A of the Securities Act of 1933, as amende d, and Section 21E of the Securities Exchange Act of 1934, as amended. Except for statements of historical fact, any information contained in th is presentation may be a forward - looking statement that reflects the Company’s current views about future events and are subject to risks, uncertainties, assu mpt ions and changes in circumstances that may cause events or the Company’s actual activities or results to differ significantly from those expre sse d in any forward - looking statement. In some cases, you can identify forward - looking statements by terminology such as “may,” “will,” “could,” “would,” “should,” “plan,” “predict,” “potential,” “project,” “promising,” “expect,” “estimate,” “anticipate,” “intend,” “goal,” “strategy,” “believe,” and similar ex pressions and variations thereof. Forward - looking statements may include statements regarding the Company’s business strategy, market size, potential growth opportunit ies , potential strategic partnerships or opportunities, capital requirements and use of proceeds, clinical development activities, the timin g a nd results of clinical trials, regulatory submissions, potential regulatory approval and commercialization of the product candidates. Although the Company b eli eves that the expectations reflected in such forward - looking statements are reasonable, the Company cannot guarantee future events, results, actions, levels of activity, performance or achievements. These forward - looking statements are subject to a number of risks, uncertainties and assumptions, including those described under the heading “Risk Factors” in our Annual Report on Form 10 - K for the year ending December 31, 2019 and our other filings with the SEC, including our Quarte rly Reports on Form 10 - Q. These forward - looking statements speak only as of the date of this presentation and the Company undertakes no obligation to revise or update any forward - looking statements to reflect events or circumstances after the date hereof. This presentation also contains estimates and other statistical data made by independent parties and by us relating to market sh ares 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 s uch estimates. The trademarks included herein are the property of the owners thereof and are used for reference purposes only. Such use shou ld not be construed as an endorsement of such products.
3 NeuroBo Pharmaceuticals Developing and commercializing multimodal disease - modifying therapies for viral, neuropathic and neurodegenerative diseases
4 ANA001 — COVID - 19 Trial • Compelling in - vitro data showing evidence of efficacy, with 50+ years of safety data • Shows great broad - spectrum antiviral activity • Data suggests effectiveness against other viruses such as influenza • Likely effective against novel SARS - CoV - 2 variants • Shows anti - inflammatory properties, without suppressing immune response • Shows promise as a prophylactic Gemcabene: Assessing for acute COVID - 19 • 25 Phase 1 and Phase 2 trials completed in Chronic Orphan Dyslipidemia indications NB - 01 — Targeting Pain in Orphan Indication • Compelling Phase 2 data showing evidence of efficacy and safety for neuropathic pain • Multimodal mechanism of action to treat pain supported by preclinical evidence NB - 02 — Targeting Alzheimer’s Disease (AD) and other dementias • IND Ready; compelling preclinical data Repurposing ANA001 as a rapid COVID - 19 treatment (Priority) Pipeline Programs Addressing Large Unmet Needs Company Overview and Merger with ANA Therapeutics
5 Development Pipeline *Due to constraints on initiating and conducting clinical studies during pandemic Enrolling Disease Indication Stage of Development Discovery Preclinical Phase 1 Phase 2 Phase 3 ANA001 COVID - 19 Moderate to Severe Patients Gemcabene COVID - 19 Acute NB - 01 Neuropathic Pain NB - 02 Alzheimer's and Dementia Postponed* Enrolling Assessing Program IND Ready
6 Proven Leadership Team • Founder of JK BioPharma Solutions and senior management at companies in immuno - oncology and natural products • Visiting Fellow at NIH and senior research experience in host - disease pathogen interactions • Co - Founder and CEO of ANA Therapeutics • Co - Founder and CEO of YourChoice Therapeutics, a Y Combinator backed startup • Previously Assistant Director of Marketing and Technology Analysis at UC Berkeley Richard J. Kang, PhD President & CEO Akash Bakshi, MsC . Chief Operating Officer • Co - Founder and CSO of ANA Therapeutics • Co - Founder and CSO of YourChoice Therapeutics, a Y Combinator backed startup • PhD in Infectious Biology from Eberhard Karls University, Tübingen, Germany • Co - Founder and COO of ANA Therapeutics • Founding CEO for AesculaTech , a Y Combinator backed startup • PhD in Chemical Engineering from the University of Southern California Nadja Mannowetz, PhD SVP, Scientific Affairs Andrew Bartynski, PhD SVP, Manufacturing and CMC
7 Expert Scientific Advisory Boards Roy Freeman, M.D. Expert in peripheral nerve disorders and neurodegenerative diseases • Professor of Neurology, Harvard Medical School • Director of the Center for Autonomic and Peripheral Nerve Disorders NEUROPATHIC PAIN SCIENTIFIC CHAIR Warner Greene, M.D., Ph.D. Expert in virology • Director of the Gladstone Institute • Professor at UCSF • Member of the national Academy of Medicine Gunda Georg, Ph.D. Expert in medicinal chemistry • Professor and Head of the Department of Medicinal Chemistry at University of Minnesota • Member of the national Academy of Medicine Christopher Davis, Ph.D. Expert in virology and clinical aspects • Ex - BARDA • Managed a NATO drug development program • 10 years at British Intelligence as principal bioweapons analyst COVID - 19 Brian Bacskai , Ph.D. Expert in Alzheimer’s Disease Research • Professor of Neurology, Harvard Medical School • Principal investigator, Neurology, Massachusetts General Hospital Pierre N. Tariot , M.D. Award - Winning Leader in Dementia • Director, Banner Alzheimer’s Institute, Arizona • Research Professor of Psychiatry, University of Arizona College of Medicine ALZHEIMER’S DISEASE & OTHER DEMENTIAS
ANA001 Targeting COVID - 19
9 What is Niclosamide? Background • On World Health Organization’s (WHO) list of essential medicines • Safely treated millions of patients • Currently used to treat tapeworm Safety Profile • Well - established drug: oral administration known to be safe for 50+ years • Very few, non - severe side effects • Appealing characteristics for most at risk population: elderly patients, high comorbidity, and children NICLOSAMIDE
10 ANA001 A cquired proprietary capsule formulation of niclosamide for COVID - 19 treatment and prophylaxis • ANA001 being studied in U.S. Phase 2/3 trial ( currently enrolling patients) • Generic niclosamide used safely for 50+ years globally as a treatment for tapeworm infections • Niclosamide prevents replication of SARS - CoV - 2 at very low concentrations • Niclosamide also shown to have three distinct mechanisms of action: • Potential Antiviral : Lowers SARS – CoV - 2 and a broad homology of other virus including Influenza. • Anti - Inflammatory : Unique MOA does not suppress immune system while reducing inflammation. • Bronchodilation : Useful mechanism for at - risk patients with underlying cardio/pulmonary conditions.
11 Broad Coverage Across Viral Homology is Important Niclosamide is effective against diverse virus families in vitro . Mutations / Another Corona Virus / Influenza Source: https:// pubs.acs.org / doi /10.1021/acsinfecdis.0c00052
12 Evidence: In - Vitro Efficacy Related to COVID - 19 Inhibition of SARS - CoV - 2 replication (Jeon et al., 2020, Antimicrob . Agents Chemother. doi:10.1128/AAC. 00819 - 20) Studies highlighting properties of niclosamide as COVID - 19 treatment ANTI - INFLAMMATORY: STAT3 INHIBITION BRONCHODILATION ANTI - VIRAL Shi et al ., 2020, unpublished Miner et al ., 2019, Front Pharma col . doi:10.3389/fphar.2019.00051 Ren et al. , 2010, ACS Med Chem Lett . doi:10.1021/ml100146z Concentration [log µM] IC50 = 11.41 Concentration [log µM] IC50 = 7.28 Concentration [log µM] IC50 = 0.28 NICLOSAMIDE Remdesivir Chloroquine
13 Niclosamide as COVID - 19 Prophylaxis • VeroFM cells were pre - treated with spermidine ( spd , 100 μ M), niclosamide ( nic , 5 μ M) or control ( veh ) 24 h prior to infection with SARS - CoV - 2 • Spermidine is a natural enhancer of autophagy to protect the body • 24 h after infection, viral replication was assessed (normalized to control) Infection with virus Analysis (assessing viral replication) GE: SARS - COV - 2 GENOME EQUIVALENTS (DETERMINED BY REAL - TIME RT - PCR) Drug washout 24 h pre - treatment with spermidine or niclosamide 24 h virus replication Gassen et al ., 2020, Preprint from bioRxiv , doi : 10.1101/2020.04.15.997254 Pre - treating cells with niclosamide reduces viral replication by ~70%
ANA001 and COVID - 19 Clinical Program
15 Update on ANA001 - 002 (Phase 1 study) SAD n=30 (8 subjects on ANA001, 2 on placebo / per cohort) Date Outcomes Cohort 1: 1,000 mg Nov 17, 2020 no AEs Cohort 2: 2,000 mg Nov 20, 2020 no AEs Cohort 3: 3,000 mg Nov 24, 2020 no AEs
16 Clinical Trial Design: Phase 2/3 Continue to PH3 Regiment 1 (n=30) Placebo (n=30) Criteria: ✓ Age >18 ✓ Moderate/Severe COVID - 19 ✓ Confirmed by RT - PCR ✓ Not on a ventilator random Screen incoming PTs (n=60) 4 days 7 days 60 days Primary Objective: Evaluate effect of dosing regimen on clinical outcomes after niclosamide therapy with 60 patients Primary Endpoint: Safety and adverse events Follow - up assessment Outcomes: Continue to P h ase 3 to test efficacy
17 Competitive Activity in Clinical Development for Niclosamide We believe NRBO is the lead program to NDA for niclosamide capsule formulation in the U.S. Company Name NCT Phase Start End Formulation Sites N ANA Therapeutics NCT04603924 2 & 3 Oct - 20 Nov - 22 O 20 sites 436 Imuneks Farma ilac San. Tic A. S. NCT04558021 3 Oct - 20 Feb - 21 O/Suspension 8 in Turkey 200 First Wave Bio NCT04542434 2 Nov - 20 May - 21 O N/A 148 First Wave Bio NCT04436458 2 Dec - 20 Apr - 21 O not listed 100 Bayer through Charite Research Organization GmbH 2020 - 002233 - 15 2 Jun - 20 Feb/Mar 2021 O Germany 72 Tufts NCT04399356 2 Oct - 20 Feb - 21 O not listed 100 Daewoong Pharmaceutical NCT04592835 1 Oct - 20 Dec - 20 IM Australia 24 Daewoong Pharmaceutical NCT04541485 1 Oct - 20 Jan - 21 IM Phillippines 40 Daewoong Pharmaceutical NCT04524052 1 N/A Dec - 20 IM India 32 Union Therapeutics EU 1 Aug - 20 N/A Inhaled N/A N/A 10 Active COVID Programs for Niclosamide Trials on U.S. and EU databases — ClinicalTrials.gov
18 COVID - 19: Timeline Slide for ANA001 Commercial Development 2 nd potential EUA Request (Jun - July) PH 3 Data Read (Jun - July) Fast Track Approval (Dec) Submit NDA (Aug - Sep) PH 2 Data (Early Sept) 1 st potential EUA Request EoP2 Meeting (Oct) Launch PH 3 Trial (Q4) Q1 – Q2 Q4 Q3 DMC 24 patients (Q1 - Q2)) 2021 Q1 Q4 Q3 2022 Q2 Clinical Timeline Complete PH2 Enrollment (June - July)
ANA001 and COVID - 19 The Changing Landscape
20 Potential Markets 1. COVID - 19 Associated Hospitalization Surveillance Network (COVID - NET) Mar - Dec 2020 2. Johns Hopkins Coronavirus Resource Center Mar - Dec 2020 3. Statista: 16.5% of 331M 4. Center for Economic and Policy Research (CEPR) April 2020 COVID - 19 Hospitalized Patients (1M in U.S.) 1 COVID - 19 Infected Individuals (20M in U.S.) 2 Prophylaxis Over 65 (55M in US) 3 Front Line Healthcare (16M in U.S.) 4 National Stockpile (25% of U.S. population)
21 • RNA Vaccine — Ultra Cold storage • Manufacturing: scale - up capacity • Most vaccines are 2 doses • Willingness of population to get vaccinated • Mutation of viral sequence may require new vaccines • Long - term efficacy • Efficacy in diverse populations • Safety — Side effects • Vaccinated individuals still spread COVID • Efficacy on new mutations Challenges: Unknowns: Vaccines are Just One Tool for COVID - 19
22 Recent Deals for COVID Antivirals
Corporate Highlights
24 Hatch - Waxman Exclusivity and Intellectual Property • NRBO is pursuing an abbreviated regulatory pathway using A 505(b)(2) New Drug Application (NDA). • This allows for referencing all the safety data from niclosamide’s original approval. • A 505(b)(2) New Drug Application (NDA) provides 3 years of market exclusivity. • Niclosamide NDA was withdrawn in 1996 due to low incidence of tapeworm in the U.S. • Three - year exclusivity period would block the approval of any generic drugs. • The three - year exclusivity period may be extended by 6 months with pediatric exclusivity. • Continue to supplement the provisional filings, which include clinical data from COVID patients. • Potential to strengthen IP in priority regions globally.
25 Financials & Cap Structure • Shares outstanding : 22.2 M • Cash position: $12.9M as of 9/30/20 • $10M Raise in January 2021 • Debt position: No debt
26 Upcoming Targeted Milestones • PK Data (SAD and MAD) (2Q 21) • Complete Phase 2 enrollment of ANA001 in m oderate to severe COVID - 19 patients (Jun/Jul 21) • Topline data from Phase 2 ANA001 in moderate to severe COVID - 19 patients (Sep 21) • Potential consideration for EUA based on Phase 2 topline data (3Q 21) • Initiate the Phase 3 portion of the ANA001 clinical trials (4Q 21)
Thank You