Form: 8-K

Current report filing

November 6, 2020

Documents

Exhibit 99.2

 Ocuphire Corporate Presentation  November 2020 
 
   Disclosures and Forward Looking Statements  2  This presentation contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements concerning Ocuphire Pharma, Inc.’s (“Ocuphire” or the “Company”) product candidates and potential. These forward-looking statements are based upon the Company’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation:(i) potential adverse reactions or changes to business relationships resulting from the announcement or completion of the merger; (ii) the success and timing of regulatory submissions and pre-clinical and clinical trials; (iii) regulatory requirements or developments; (iv) changes to clinical trial designs and regulatory pathways;(v) changes in capital resource requirements; (vi) risks related to the inability of the Company to obtain sufficient additional capital to continue to advance its product candidates and its preclinical programs; (vii) legislative, regulatory, political and economic developments, and (viii) the effects of COVID-19 on clinical programs and business operations. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors detailed in documents that have been and may be filed by the Company from time to time with the SEC (including the proxy statement/prospectus included in that certain Registration Statement on Form S-4 (File No. 333-239702) initially filed with the SEC on July 6, 2020 and declared effective by the SEC on October 2, 2020). All forward-looking statements contained in this presentation speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.The Company makes no representation or warranty, express or implied, as to the accuracy or completeness of the information contained in or incorporated by reference into this presentation. Nothing contained in or incorporated by reference into this presentation is, or shall be relied upon as, a promise or representation by the Company as to the past or future. The Company assumes no responsibility for the accuracy or completeness of any such information. This presentation may not be reproduced or provided to any other person (other than your advisor) without our prior written consent. By accepting delivery of this presentation, you agree to the foregoing and agree to return this presentation and any documents related thereto and any copies thereof to us or to destroy the same if you do not make an investment in any securities. The information contain within this presentation shall not, except as hereinafter provided, without the prior written consent of the Company, be disclosed by you or your representatives in any manner whatsoever, in whole or in part, and shall not be used by you or your representatives other than for the purpose of evaluating the transaction described herein. By accepting delivery of this presentation you further acknowledge and agree aware of the restrictions imposed by the United States securities laws on the purchase or sale of securities by any person who has received material, nonpublic information from the issuer of the securities or any affiliate thereof and on the communication of such information to any other person when it is reasonably foreseeable that such other person is likely to purchase or sell such securities in reliance on such information for so long as the information remains material and non-public. This presentation also contains estimates and other statistical data made by independent parties and by us relating to market shares 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. The trademarks included herein are the property of the owners thereof and are used for reference purposes only. Such use should not be construed as an endorsement of such products. 
 
   Ocuphire - New Public Ophthalmic Drug Development CompanyNasdaq Symbol: OCUP  Nasdaq public listing allows for capital access, investor liquidity, and strategic visibilityReverse merger with Rexahn and financing transaction announced in June, closed in NovemberOcuphire management team, expanded board and field-leading SABNo Rexahn legacy operating/capital obligations (CVR for Rexahn shareholders on existing agreements with Biosense and Haichang)REXN represented by Oppenheimer for the mergerConcurrent $21+ million PIPE financing led by Altium CapitalPro forma cash provides sufficient capital to fund 4 late-stage clinical trials through their respective readouts in 2021Financing co-led by Cantor Fitzgerald and Canaccord GenuityOcuphire focusing exclusively on ophthalmic drug developmentTwo lead assets: Nyxol Eye Drops and APX3330 oral tabletsTwo Phase 3 trials and two Phase 2 trials expected to readout in 2021    November 6, 2020  3 
 
                   Ocuphire Management TeamDecades of Biotech and Drug Development Experience  Mina Sooch, MBA Chief Executive Officer  25 years in pharma/biotech industry as a CEO, entrepreneur, venture capitalist and strategist. Raised over 100 million dollars for 2 biotechs, then led private to public on Nasdaq, Recognized as MI Newsmaker of the Year.              Konstantinos Charizanis, PhD, MBA Senior Director of Market Strategy and R&D  Drey ColemanDirector Clinical Operations and Vendor Management    Charlie Hoffmann, MBAVP Corporate Development and Operations  25 years in life sciences fundraising, corporate finance, licensing and M&A transactions, and corporate development, Long time advisor to Ocularis/Nyxol.  14 years in medical research, product development, market research, and biotech business development, with a focus on financial modeling, patents and genetics.  15 years in ophthalmic pharmaceutical research and development as sponsor and CRO with a focus on clinical operations, vendor management, pharma regulations, and successful contract negotiations.    18 years in finance and accounting, for private and public companies, with a focus on life sciences. Held progressive roles including Controller, Director of Finance, and acting CFO.  Amy Rabourn, CPA VP Finance                                4 
 
   Late Clinical Stage Company Targeting Large, Unmet Ophthalmic Markets  Significant Clinical Data  Significant IP Portfolio and Small Molecule CMC Advantages  Multiple Near-Term Data Catalysts with Capital Efficient Plan  Nyxol targets multiple chronic and acute front of the eye indications addressing large markets: Dim Light or Night Vision Disturbances (NVD), Reversal of Mydriasis (RM), and Presbyopia (P)APX3330 targets chronic back of the eye indications: Diabetic Retinopathy (DR) and Diabetic Macular Edema (DME), a leading cause of blindness in diabetic patients  Nyxol and APX3330 achieved promising clinical data over multiple Phase 1 and 2 trialsNyxol with > 150 patients treated across 7 trialsAPX3330 with > 340 patients treated across 11 trials  US and global issued patents thru 2034 obtained for both assetsStable, small-molecule drugsNyxol = single-use, preservative-free eye dropAPX3330 = oral pill  4 late stage trial readouts (2 Phase 3, 2 Phase 2) expected in 1Q through 4Q 2021Capital-efficient operations with a Nyxol NDA filing in one or more indications by early 2023  Ocuphire OpportunityA Late-Stage Clinical Ophthalmic Biotech    Nyxol® APX3330    5 
 
 6    Large Unmet Opportunities for the Aging EyeDeveloping Drugs to Treat Front & Back of the Eye Diseases  Source: GlobalData Market Research Report, 2020              Night Vision DisturbancesU.S. Prevalence: ~16M adultsReversal of Mydriasis~100M pupil dilations per year in U.S.PresbyopiaU.S. Prevalence: ~120M        $4-10B US Markets              Front Back  Nyxol®  APX3330    Diabetic RetinopathyU.S. Prevalence:~ 7MDiabetic Macular EdemaU.S. Prevalence: ~750K        $4-10B US Markets                   
 
     Product Candidate  Indication  Development Stage        Anticipated Milestones        Pre-clinical  Phase 1  Phase 2  Phase 3    Ocuphire-Focused Development  0.75% Nyxol®Eye Drop  Dim Light or Night Vision Disturbances (NVD)          Initiate Phase 3 LYNX-1 trial 4Q2020; Data expected in 3Q21 (n=160)    0.75% Nyxol®Eye Drop  Reversal of Mydriasis (RM)          Initiate Phase 3 MIRA-2 trial 4Q2020; Data expected in 1Q21 (n=168)    0.75% Nyxol® + Low-Dose Pilocarpine Eye Drops  Presbyopia (P)          Initiate Phase 2 VEGA-1 trial 1Q2021; Data expected in 2Q21 (n=152)    APX3330Oral Pill  Diabetic Retinopathy (DR)/ Macular Edema (DME)          Initiate Phase 2 ZETA-1 trial 1Q2021; Data expected in 4Q21 (n=100)  Partnering- Focused Development  APX2009 Intravitreal  DME, Wet Age-Related Macular Degeneration (wAMD)          Next steps: IND enabling studies (with partner funding)    Combo (0.75% Nyxol®+ Latanoprost) Eye Drops  Glaucoma(16 to 24 mmHg)          Next steps: 2nd line add-on Phase 2 trial (with partner funding)    Ocuphire Pipeline & Upcoming MilestonesMultiple Phase 3 & Phase 2 Clinical Data Catalysts Expected Throughout 2021            Note: 0.75% Nyxol (Phentalomine Ophthalmic Solution) is the same as 1% Nyxol (Phentalomine Mesylate Ophthalmic Solution)  7 
 
         11 >340Phase 1 & Phase Subjects Dosed 2 Trials    Exposure in Humans365Days    Patents to2034+        Extensive Development on Both Drug CandidatesWell-Controlled Phase 1 & Phase 2 Clinical Programs Set Stage for NDA Path  NCE Development Pathway  Studied in inflammation/hepatitis & cancer patients    7Phase 1 & Phase 2 Trials    > 150Subjects Dosed    Exposure in Humans28Days    Patents to2034+        505(b)(2) Development Pathway  8  Studied in ocular refractory diseases (NVD) & elderly glaucoma patients  Nyxol  APX3330 
 
         Nyxol®      Phentolamine Mesylate      NVD Night Vision Disturbances      P Presbyopia      RM Reversal of Mydriasis  9 
 
   Nyxol History & MOARationale for Differentiated Product Profile & 505(b)(2) Path      Nyxol’s active ingredient, phentolamine mesylate (PM), iscurrently approved for 2 indicationsPheochromocytoma (60+ years ago, Regitine®) – intravenous injectionReversal of oral anesthesia (10+ years ago, OraVerse®) – intramuscular injection  PM has been reformulated as a topical eye drop (Nyxol)Nyxol is a first-in-class non-selective α1 and α2 blockerproduct candidateMOA of relaxing the iris dilator muscle (α1)Redness is an on-target α1 effect on sclera vessels (transient, mild)      Phentolamine Mesylate  Dilates Blood Vessels (Vasodilation)α1: Smooth Muscle Blockade  Reduces Pupil Sizeα1: Iris Dilator Blockade          10 
 
           Efficacy Data    Improving Vision↓ Pupil Size (moderate miotic)↑ Contrast Sensitivity (night)↑ Near Visual Acuity (light/dark)↑ Distance Visual Acuity              Safety Data    No Systemic EffectsNo Changes in Blood Pressure No Changes in Heart RateTolerated Topical EffectsMild / Transient / Reversible Eye RednessIOP Unchanged or Decreased↓ Intraocular Pressure (IOP) at Normal Baseline      Nyxol Product Candidate ProfileFirst-in-Class Alpha 1/2 Blocker Eye Drop for Refractory Indications  Nyxol: Phentolamine 0.75% Ophthalmic Solution Preservative Free, EDTA Free, and Stable  Chronic daily dosing of Nyxol at bedtime demonstratedno significant daytime redness and durability of effects for more than 24 hours    11 
 
 12    Moderate-to-Severe NVDs  US Patients  Night Myopia  10.8M  Cortical Cataracts  4.1M  Post-LASIK  500k  Post-IOL Implant  300k  Total  ~16M    Night Vision Disturbances (NVD) – Chronic OpportunityImperfections in the Eye Affect Night Vision in Millions  Peripheral imperfections scatter light when pupils enlarge in dim light, causing halos, starbursts, and glare that impair visionThe imperfections maybe caused by LASIK surgery, IOL implants, certain types of cataracts (cortical), and natural reasons (especially with age)Symptoms cannot be properly corrected by any type of lens (reading glasses, contact lenses) or surgical procedures  Source: GlobalData Market Research Report, 2020  The Problem  No Currently Approved Therapies      NVD  I’m no longer comfortable driving at night, especially with my son in the car. I have a hard time playing beach volleyball in the evenings due to the bright lights at the courts.Post-LASIK, aged 42     
 
   Night Vision Disturbances (NVD) – Chronic OpportunityPeripheral Optical Imperfections Allowing Pupil Modulation as a Solution  Moderate Decrease in Pupil Size for scattered light gets blocked by the irisClinical Effect to potentially improve low contrast night vision as seen in trialsTolerable with a minimal side effect profileConvenient and Durable with chronic once-daily evening dose  Nyxol’s Potential Differentiated Solution              After  Before      NVD  It seems like a simple processwith really no side effects.Cataract respondent, aged 62      13 
 
         NVD LYNX-1 Phase 3 Registration DesignPlanned Randomized, Double-Masked, Placebo-Controlled Trial  LYNX-1          Endpoints    Primary: % of subjects with≥ 3 lines of improvement inmesopic low contrast best- corrected distance visual acuity (Day 8)Secondary (Days 8 & 15):Pupil diameterVisual acuity measures (distance and near)Safety and tolerability (redness)      Eligibility Screening  Randomization  1:1          0.75% Nyxoldaily evening dose (14 days)      daily evening dose (14 days)  Placebo  15 US sites~160 patients with NVD      NVD    Phase 3 Start Targeted for 4Q20    Top Line Expected 3Q21  14 
 
 15          ORION-1 Phase 2 Trial  Nyxol Demonstrated Clinical Effect in NVDKey Endpoints Observed in Multiple Phase 2 Trials  Source: NYXG-201    % of Subject Eyes    NYX-SNV Phase 2 Trial          Improved Low Contrast Distance Visual Acuity*% of Eyes with Mesopic Low Contrast Visual Acuity Improvementp=0.029p=0.04p=0.16Source NYX-SNV        Pupil Diameter Change from Baseline ANCOVA (mm)  Durable > 24 hour Pupil Modulation EffectPupil Diameter Change from Baseline in Mesopic Conditions (Study Eye)Baseline Pupil Diameter: Placebo 4.6mm, Nyxol 4.7mm        NVD  * NYX-SNV trial was small and not designed for a statistical 3-line improvement in low-contrast visual acuity; the 20% effect was used for powering and size of Phase 3 trial 
 
 16    Reversal of Mydriasis (RM) – Acute TreatmentAnnual Exams and Specialty Visits Involve Dilation to Monitor Eye Health  At every annual eye exam and many specialty visits, patients’ pupils are pharmacologically dilated, impairing vision for 6-24 hoursDilated eyes:heightened sensitivity to lightinability to focusreading, working, and driving are difficult  The Problem  ~100M eye exams / year in US    No Currently Approved Therapies      RM  Source: GlobalData Market Research Report, 2020  I have to stay indoors. They say it only lasts a few hours, but it lasts all day, and it is very annoying.RM Patient, Aged 51     
 
 17    Reversal of Mydriasis (RM) – Acute TreatmentSingle Use Indication Leveraging a Precedent Approval Pathway  Regulatory Precedent with RevEyes (an alpha 1 blocker), approved by the FDA in 1990 but shortly thereafter discontinued (not for safety or efficacy reasons)Clinical Effect to potentially reduce pupil size and reverse mydriasis by counteracting the drugs (alpha agonists and cholinergic blockers) used to dilate the pupilConvenient eye drop given at the office that mayallow patients’ vision to return to normal soonerTolerable with a minimal side effect profile  Nyxol’s Potential Differentiated Solution          RM  After  Before 
 
 18    RM MIRA-2 Phase 3 Registration DesignPlanned Randomized, Double-Masked, Placebo-Controlled, Parallel, One-Day Trial  MIRA-2      0.75% NyxolMydriatic Agent A, B, or C  12 USsites~168healthy subjects      Nyxol drop(s) (1 day)      Mydriasis Time -1 HourPlaceboMydriatic Agent A, B, or C      Placebo drop(s) (1 day)  TreatmentTime 0 (Max Dilation)      RM          Endpoints    Primary: % of subjects returning to baseline (within 0.2 mm) pupil diameter at 90 min or lessSecondary:% of subjects returning to baseline at 30min, 1h, 2h, 3h, 4h, 6h, 24hMean change in pupil diameter from mydriatic max at all timepointsAccommodation (Tropicamide)Safety and tolerability (redness)        Phase 3 Start Targeted for 4Q20    Top Line Expected 1Q21  Eligibility Screening  Randomization  Mydriatic Agents: Phenylephrine, Tropicamide, Paremyd® (combination)        1:1 
 
 19          Nyxol Demonstrated Clinical Effect in RMKey Endpoints Observed from MIRA-1 Phase 2b Trial  MIRA-1 Phase 2 Trial      RM    Nyxol Reduces More Subjects to Pupil Diameter (PD) BaselinePercent of Subjects Returning to ≤ 0.2 mm of Baseline after Treatment With either Phenylephrine or Tropicamide  Nyxol Reduces PD Faster Across Phenylephrine & Tropicamide Mydriatic agentsReduction in Pupil Diameter after Patients received either Phenylephrine 2.5% or Tropicamide 1.0% in Study Eye  Percent of Subjects (%)    p=0.0262p=0.1094  p=0.0001  Pupil Diameter (mm)  *p<0.05; **p<0.01; ***p<0.001; ****p<0.0001     
 
 20    Presbyopia – Chronic OpportunityAging Population Drives Demand for Alternatives to Reading Glasses  Lens loses ability to change shape when viewing objects up close as we ageDependence on reading glasses for intermittent and prolonged useGrowing need for therapies that improve, rather than hinder, quality of life  Source: GlobalData Market Research Report, 2020  The Problem        P    120 MPatients  No Currently Approved Therapies  Effectively everyone over 40 will have the problems with reading.Physician KOL     
 
 21    Presbyopia – Chronic OpportunityPupil Modulation Eye Drops May Replace Reading Glasses  “Pin-hole” effect of Nyxol and low dose pilocarpine may improve near vision by increasing depth of focus as validated by other devices/therapiesMore durable combination of two miotics affecting different muscles involved in pupil size modulationTolerable use with minimal side effects expected with chronic evening use of Nyxol  Retinaeyedoctor.com,, GlobalData Market Research Report, 2020  Nyxol’s Potential Differentiated Solution      Large Pupil  Pin-hole Pupil  Near Far          In focus          In focus              P  This would just become part of my daily routine for my eyes to be able to see things up close. How convenient is that?Presbyopic Patient, age 49     
 
 22    Presbyopia VEGA-1 Phase 2 Proposed DesignPlanned Randomized, Double-Masked, Placebo-Controlled Trial  Visit 1      VEGA-1  Eligibility Screening  Randomization    4 arms    0.75% Nyxol  Placebo  20 US sites~152presbyopic patients  Visit 2(3 – 5 Days Later)  Screening      P          Endpoints    Primary: % of subjects with ≥ 3 lines of improvement in distance- corrected near visual acuity comparing Nyxol + LDP vs placebo alone at 1 hourSecondary:% of subjects with ≥ 2 and ≥ 3 lines gained at time points from 30 min to 6 hours in photopic and mesopic lighting comparing Nyxol + LDP vs placebo, Nyxol alone, and LDP aloneNo loss of distance visionPupil diameter at time pointsSafety and tolerability (redness)        Phase 2 Start Targeted for 1Q20    Top Line Expected 2Q21  LDP= low-dose pilocarpine (0.4%)        Treatment Arms    Nyxol + LDP  LDP Drop      Nyxol      Baseline          Nyxol Alone  No Treatment      Nyxol      Baseline          LDP Alone  LDP Drop      Placebo      Baseline          Placebo Alone  No Treatment      Placebo      Baseline   
 
 Nyxol Demonstrated Clinical Effect in PresbyopiaKey Endpoints Observed from Multiple Phase 2 Trials  Source: ORION-1        Nyxol Alone LDP AloneAverage pupil size in photopic conditions is 3.5 to 4+ mm  ~0.7 to 1+ mm      P      ORION-1 Phase 2 Trial  Pinhole PD Size Illustrated with Addition of LDP to Nyxol1.5 to 2+ mm PD reductionAchieve the pin-hole (1.6 to 2 mm) effect        Percent of Subjects with VA Line Improvements  23  Improvements in DCNVA with Nyxol Alone With No Change in Distance VisionNear VA Line Improvement at Day 15 (Full Analysis Set, Study Eye, Photopic)*p=0.026  ~0.7 to 1+ mm 
 
         APX3330  APX3330      DR Diabetic Retinopathy      DME Diabetic Macular Edema      wAMD    Wet Age-Related Macular Degeneration      24 
 
 25    APX3330 is a Ref-1 InhibitorRef-1 Involved in Multiple Pathways that Contribute to Diabetic Retinopathy and DME  Mechanism of Action – Ref-1 Inhibition  Hypoxia  Ref-1  HIF-1α  VEGF(Signaling Cascade)  Inflammation  Ref-1  NF-κB  Other Growth Factors (Signaling Cascade)  TNF-αChemokines  Neovascularization                  Lucentis® EYLEA®    Anti-VEGF      Steroids            APX3330  Logsdon et al (2018), Li et al (2014).      APX3330 is a small molecule oral drug candidate and a first-in-class inhibitor of Ref-1Ref-1 (reduction-oxidation effector factor-1) is a novel target discovered and characterized by Dr. Mark R. Kelley at Indiana University School of MedicineAPX3330 previously developed by Eisai for multiple hepatic inflammatory indications and later by Apexian for advanced solid tumors– Similar oncology origin as approved anti-VEGFsMOA uniquely decreases both abnormal angiogenesis and inflammation by blocking pathways downstream of Ref-1   
 
 26    APX3330 Product Candidate ProfileFirst-in-Class Ref-1 Inhibitor Phase 2 Ready for Retina Diabetic Indications          Expected Efficacy Data    Improving Eye Health in Diabetics↓ Inflammation↓ Hypoxia Signaling↓ Abnormal AngiogenesisEnhance Compliance & Exposure Oral pill may reduce the burden of frequent anti-VEGF injections              Safety Data    Few Systemic Adverse EffectsMild Gastrointestinal (diarrhea)Mild Skin Rash (Reversible)Lack of Significant Acute Neurologic, Cardiovascular, Liver, or Pulmonary toxicityNo Topical EffectsNo observed ocular AEs      APX3330: 600mg Oral Dose (120mg or 300mg tablets)  Twice a day dosing of APX3330 anticipated to provide steady state effectiveness with a tolerable chronic safety profile   
 
 27    Diabetic Eye Opportunity    DR  ~7.7M Patients  DME  ~750K Patients  Diabetic Retinopathy & Macular EdemaNon-Injectable Alternative Therapies are Needed For Earlier Stages of Disease  Diabetic retinopathy (DR) and diabetic macular edema (DME) are a leading cause of vision loss worldwide, especially in working age adults in developed countriesDiabetes damages small blood vessels within the eye causing leakage, oxygen starvation, and abnormal vessel growth, which can obstruct visionCurrent treatment: 25% non-responders, 50% partial responders to anti-VEGF  Sources: Global Market Insights Report 2019-2025, Market Watch 2019 Report, Gene.com Retinal Diseases Fact Sheet  The Problem  Injectable Anti-VEGF Approved Therapies Not Commonly Used for NPDR  “Cotton Wool” Spots  Diabetic Eye      Hemorrhages AneurysmAbnormal Blood Vessels        DR      DME 
 
 28    Diabetic Retinopathy & Macular EdemaAPX3330 to Treat Patients Before Vision Loss Occurs  Potential First Oral Therapy to be used as an earlier intervention for the diabetic eye before vision symptoms appear or as add-on therapy to current anti-VEGF treatmentProven Unique Mechanism that may decrease both inflammation and VEGF activityConvenient option for patients to potentially alleviate the burden of injections and increase complianceTolerable as seen in 11 completed Phase 1 and Phase 2 clinical trials  EYLEA Product Pamphlet  APX3330’s Potential Differentiated Solution      DR      DME              DR  DME 
 
 29    DR/DME ZETA-1 Phase 2 Proposed DesignPlanned Randomized, Double-Masked, Placebo-Controlled Trial  NPDR = non-proliferative diabetic retinopathy (which includes non centrally involved diabetic macular edema) PDR = proliferative diabetic retinopathy (which includes non centrally involved diabetic macular edema)        ZETA-1  Eligibility Screening  Randomization  1:1          APX3330 600mgTwice daily oral dose(24 weeks)      Twice daily oral dose (24 weeks)  Placebo  15 US sites~100 patients with moderate- to-severe NPDR and mild PDR      DR      DME      Primary: % of subjects with a ≥2 step improvement on the DRSS (DiabeticRetinopathy Severity Scale) score at week 24Secondary:Central subfield thickness (CST)BCDVA (ETDRS)Safety and tolerabilityExploratory:Labs / PK      Endpoints    Phase 2 Start Targeted for 1Q21    Top Line Expected 4Q21 
 
   APX3330 Generally Well Tolerated with Clinical SignalsObservations from Pre-Clinical Studies and 11 Clinical Trials of APX3330      L-CNV Mouse Retina Model          APX3330 Reduces Neovascularization Similar to Eylea in Preclinical ModelsLesion Size and Corresponding Fluorescent Stains in L-CNV Models Treated with APX3330 at 25 mg/kg-55%          Phase 1 Clinical Trials          Human Drug Exposure Multiple Times Higher than Mouse Efficacious LevelsHuman Pharmacokinetics of APX3330 at 120 mg/kg/day          DR      DME  30 
 
 Boards and Milestones  31 
 
       Richard Lindstrom, MD University of Minnesota    Ed Holland, MDLoyola University Chicago      Jay Pepose, MD UCLA        Jack Holladay, MD University of Texas      Thomas Samuelson, MD University of Minnesota      Paul Karpecki, OD Indiana University  elCON MedicalEliot Lazar, MDGeorgetown University      Gary Novak, PhD UC Davis    Marguerite McDonald, MD Columbia University      David Boyer, MD Chicago Medical School    Gerald Horn, MD University of IllinoisCo-Founder Ocularis/Nyxol      Mark Kelley, PhD Indiana UniversityCo-Founder Apexian/APX3330              Prestigious Ocular Medical Advisory BoardFortunate for the Insights of Leading KOLs & Drug Candidate Co-Founders  Michael Allingham, MD, PhD University of North Carolina  Richard Messmann, MD Wayne State University CMO Apexian/APX3330                  Peter Kaiser, MD Harvard Medical School          Jeffrey Heier, MD Boston University  32 
 
             Ocuphire Board of DirectorsSeasoned Directors with Decades of Biotech Drug Development and M&A/Financings                      Sean Ainsworth, MBALead Independent Director,Board Director  James Manuso, PhD/MBABoard Director  Alan R. Meyer, MBABoard Director MFR/IP Advisor                          Richard Rodgers, MBABoard Director              Susan Benton, MBABoard Director                  Cam Gallagher, MBAChair, Board Director                        Mina Sooch, MBA  Vice-Chair, Board DirectorPresident & CEO                  33 
 
         2020 to 2022 Cadence of MilestonesMultiple Data Catalysts for Value-Building      Nyxol NDA filing for RM & NVD in early 2023  Ongoing partnering discussions with leading ophthalmic companies (inc. European and Asian players)  NVD Podium Presentation at AAO 2018Initiate/Report Phase 2b Data for ORION-1Initiate/Report Phase 2b Data for MIRA-1Expand Patent Estate  Completion of APX3330 LicenseARVO 2020Presentation for MIRA-1ARVO 2020Presentation for ORION-1FDA EOP2 Meeting May 2020  Announced Ocuphire Reverse Merger and PIPE Financing (Co- Led by Cantor and Canaccord)Completion of Transaction (Nasdaq: OCUP)Initiate Phase 3 RM TrialInitiate Phase 3 NVD TrialComplete Nyxol Market ResearchJournal Publications  Initiate Phase 2 Presbyopia TrialInitiate Phase 2 DR/DME TrialReport Phase 3 Data for RMReport Phase 2 Data for PresbyopiaNew Patent Claims on P/RM/G  Report Phase 3 Data for NVDReport Phase 2 Data for DR/DMEInitiate 2nd Phase 3 Trials (RM, NVD)Initiate Acute and Chronic Phase 3 Safety TrialInitiate Phase 3 Presbyopia Trial  Report 2nd Phase 3 Data for RM and NVDReport Phase 3 Safety DataReport Phase 3 Data for PresbyopiaInitiate Phase 3 DR/DME Trial and 2nd Phase 3 Trial for Presbyopia  2018/2019      1H 2020      2H 2020      1H 2021      2H 2021      2022      34 
 
       Restore Vision & Clarity    www.ocuphire.com ir@ocuphire.com 
 
 36    NVD Endpoint: 5% Low Contrast Visual Acuity (LCVA) ChartFDA Accepted Endpoint for Contrast Sensitivity Assessment  Precision Vision                    Before Treatment* 3 Lines Improvement Illustration          Primary Endpoint of Nyxol LYNX-1 TrialPercent of subjects with ≥ 3 lines of improvement in mesopic low contrast best-corrected distance visual acuity(7 days)  * Inclusion Criteria includes subjects with baseline mesopic LCVA of 20/100 or worse     
 
 37    DR/DME Endpoint: Diabetic Retinopathy Severity Scale (DRSS)FDA Accepted Endpoint for DR (EYLEA® in PANORAMA Pivotal Trial)  EYLEA Product Pamphlet ®    1  2  3  4  5, 6  7 – 13  DRSS  (10)  (20)  (35)  (43)  (47, 53)  (60, 61, 65,  Score            71, 75,              85,90)  Description  DR Absent  Micro- aneurysm only  Mild NPDR  Moderate NPDR  Moderately Severe NPDR  PDR – Mild, Moderate, and Severe  Retinal Image  Healthy blood vessels with no  Small bulges in blood vessel  More changes in the blood vessels  More blood vessels in larger  Many of the blood vessels in  Increased growth of new, damaged    bulges  walls as well as  in the retina and  areas of the  the retina show  blood vessels      other signs in the  small spots of  retina show  visible changes        retina  blood can  changes            become more              visible                    Patients included in the ZETA-1 Trial  Primary Endpoint of APX3330ZETA-1 TrialPercent of patients with a ≥ 2 step improvement on the DRSS score at week 24  A 13-point Scale Outlining the Various Stages of Diabetic Retinopathy 

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