EX-99.2 3 brhc20052778_ex99-2.htm EXHIBIT 99.2
Exhibit 99.2

 Ocuphire Corporate Presentation  May 2023 
 

 Disclosures and Forward-Looking Statements  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 the success and timing of planned regulatory filings and approvals, pre-commercial activities, commercialization strategy and timelines, business strategy, product labels, cash runway, scalability, future clinical trials in presbyopia (P), dim light/night vision disturbance (DLD) and diabetic retinopathy (DR) / diabetic macular edema (DME), including the potential for Nyxol to be a “best in class” presbyopia drop, and timing of planned future clinical trials for APX3330, timing and occurrence of an End-of-Phase 2 meeting with the FDA, the potential of a Phase 3 registration path for APX3330, the success and timing of planned regulatory filings, business strategy, cash runway, scalability, the potential for APX3330 to be the first line of therapy for DR patients, and the potential market opportunity for the slowing of DR progression. 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) the success, costs, and timing of regulatory submissions and pre-clinical and clinical trials, including enrollment and data readouts; (ii) regulatory requirements or developments; (iii) changes to clinical trial designs and regulatory pathways; (iv) changes in capital resource requirements; (v) risks related to the inability of Ocuphire to obtain sufficient additional capital to continue to advance its product candidates and its preclinical programs; (vi) legislative, regulatory, political and economic developments, (vii) changes in market opportunities, (viii) risks that the partnership with Viatris may not facilitate the commercialization or market acceptance of Ocuphire’s product candidates; (ix) the success and timing of commercialization of any of Ocuphire’s product candidates, including the scalability of Ocuphire’s product candidates and (x) the maintenance of Ocuphire’s intellectual property rights. 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. 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 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.  2 
 

 Corporate Highlights  Two Lead Clinical-Stage Novel Drugs Addressing Multiple Large Ophthalmology Markets with Limited to No Competition & Extensive Patent Portfolio  Global License Agreement with Viatris to Fund the Development and Commercialization of Nyxol for All Indications  Strong Financial Position to Advance APX 3330 and Nyxol Clinical Programs into 2025  Nyxol for RM Indication PDUFA Date on September 28, 2023  APX3330 – Paradigm Changing Oral Tablet for 8 million DR patients; Moving into Phase 3   APX3330 oral tablets  Diabetic Retinopathy/Diabetic Macular Edema (DR/DME)  Nyxol eyedrops  Reversal of Mydriasis (RM) – eye dilation  Presbyopia (P) – age-related blurry near vision  Dim Light or Night Vision Disturbances (DLD)  3 
 

 Product Candidate  Indication  Pre-clinical  Phase 1  Phase 2  Phase 3  Regulatory  Approval  Upcoming Milestones  APX3330   Oral Pill  Diabetic Retinopathy (DR)/ Macular Edema (DME)   EOP2 Mtg 2H 2023 to Advance to Phase 3   Nyxol®  Eye Drop   Reversal of Mydriasis (RM)   PDUFA Date Sep 28, 2023  Nyxol®  Eye Drop  Presbyopia (P)  VEGA-2 Phase 3 Topline Data Late 2023   Nyxol® +   0.4% Low Dose Pilocarpine (LDP)   Eye Drops  Nyxol® +   0.4% Low Dose Pilocarpine (LDP)   Eye Drops  Nyxol®  Eye Drop  Dim Light or   Night Vision Disturbances (DLD)  LYNX-2 2nd Phase 3 trial (n=150+)     Ocuphire Pipeline  Partnered with Viatris      Partnered with Viatris  Partnered with Viatris   EOP2  Meeting  PDUFA  Sept 28, 2023  Ph3  Initiated  4 
 

 Global Partnership with Viatris for Nyxol  Viatris Has Selected Nyxol to be a Key Element of its Global Eye Care Division   Fully funded development and commercialization costs for all 3 Nyxol indications   Partner for Nyxol global commercialization   Allows Ocuphire to focus on APX3330 development  Strengthens cash position into 2025  $35 million upfront  Funding for potentially all R&D and commercialization for all 3 indications globally  $130 million in regulatory and sales milestones  First potential $10 million milestone payment on FDA approval in RM  Tiered double digit royalties through 2040  5 
 

 6  APX3330  ORAL TABLET  DR  Diabetic Retinopathy  DME  Diabetic Macular Edema  “  ”  “I could lose my hearing, I could lose talking but…. It’s frightening to lose my eyesight.”  Patient Diagnosed with DR 
 

 Diabetic Retinopathy At a Glance  Larger Disease to Manage with Growing Diabetes  There are 8M adults in the  U.S. with DR1  DR is the leading cause of blindness  among working-age adults  DR/DME affects about  1 in 4 people with  type 1 and type 2 diabetes  Majority of patients with mild to moderate DR are not treated with anti- VEGF due to injection fear and burden  $13B (2020)  Global Intravitreal Injection Revenues  7  American Diabetes Association; International Diabetes Federation; Healthline 
 

 DRSS Predicts Vision-Threatening Complications (PDR/DME)  8  Early treatment diabetic retinopathy study research group. ophthalmology. 1991;98(5 suppl):823-33.   Diabetes control and complications trial research group. N Engl J Med. 1993;329(14):997-86.  Fathy C, Patel S, Sternberg P Jr, Kohanim S. Disparities in adherence to screening guidelines for diabetic retinopathy in the United States: a comprehensive review and guide for future directions. Semin Ophthalmol. 2016;31(4):364–377. doi: 10.3109/08820538.2016.1154170  Early screening and treatment for DR can reduce vision loss by up to 94%  1 Year Follow-up  3 Year Follow-up  5 Year Follow-up  Percentage of Eyes that Worsen to PDR  Regardless of severity, all eyes worsen over time  
 

 Broad Opportunities to Treat Retinal Diseases with APX3330  Source:1. American Diabetes Association; International Diabetes Federation; Healthline; *Ocuphire internal analysis and assumptions;  2. Das UN. DME, retinopathy and age-related macular degeneration as inflammatory conditions. Arch Med Sci. 2016;12(5):1142-1157. doi:10.5114/aoms.2016.61918  3. Patient survey adapted from Lions International Foundation and International Diabetes Foundation-Europe; Meltzer 2000  4. Estimates are provided by the National Eye Institute, FactSheet, Global Data, and Research and Markets. Estimated values are rounded. 5. Estimated prevalence in the U.S.; DME- Diabetic Macular Edema; Age-related Macular Degeneration; Geographic Atrophy; Retinal Vein Occlusion  9  Diabetic Retinopathy  PDR(DRSS >60)  Moderate to Severe NPDR (DRSS 43-53)  Mild NPDR  34 Million Diabetics in US  10M  6M  1M  1M  ~8M+DR Patients  Anti-VEGF treatments  APX3330  APX3330 / APX2009 / APX2014 (Local Delivery)  US Market   Opportunity  Addressable Market  Potential First Oral Rx for Retina Diseases with Multi-Billion Revenue Opportunity  APX3330  ~$10B+  Market Revenues  DME  1M  Wet AMD  2M  Dry AMD  10M+  GA  1M  Inflammatory component is common across these retina indications as well & potentially addressable by MOA of Ref-1  
 

 APX3330 Profile Overview  Oral, First-In-Class Ref-1 Inhibitor with Favorable Human Safety Data from 12 Completed Trials  Novel MOA for Treating Retina  ↓ Inflammation  ↓ Abnormal Angiogenesis  Good Patient Compliance in ZETA-1 with Convenient Oral Dosing  APX3330 Demonstrated Slowing of Progression of Diabetic Retinopathy  Over 350 Subjects (Healthy, Liver, Cancer, Diabetic) treated with Several Subjects Systemically Dosed ~1 Year and Others at 24-Wks  Few Systemic AEs Across All Doses (120mg-720mg)  < 5% Mild Skin Rash/Pruritis (reversible)  < 5% Mild Diarrhea  No Treatment-Related Organ Toxicity  Minimal Ocular Side Effects*  APX3330: Well-tolerated Oral Dose up to 600 mg/day | Twice Daily Dosing  MOA and Efficacy Signals in DR Favorable Safety Profile  10  Source: ZETA-1 Clinical Trial  *1 subject had vision blur thought to be related by investigator in ZETA-1 
 

 Sources: Logsdon et al (2018), Li et al (2014).  APX3330 Ref-1 Inhibition – Decreases Abnormal Angiogenesis  Ref-1 Involved in Multiple Key Pathways that Contribute to DR 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-α  Chemokines  Neovascularization  Lucentis® EYLEA®  Anti-VEGF  Steroids  APX3330  Ref-1 (reduction-oxidation effector factor-1), a novel target for retinal diseases, is a transcription factor regulator of angiogenesis (VEGF) and inflammation (NFkB)  Unique dual MOA decreases abnormal angiogenesis and inflammation   Anti-VEGF injections do not target inflammation  Previously developed by Eisai for hepatic inflammatory indications and by Apexian for solid tumors in 11 Phase 1 and 2 trials  Extensively studied in over 20 in-vitro and animal studies with favorable efficacy and safety  11 
 

 Primary:   % subjects with ≥ 2 step improvement on DRSS (Diabetic Retinopathy Severity Scale1) at week 24  Secondary:  DRSS worsening ≥1, ≥2, ≥3*, ≥4*  DRSS worsening ≥1, ≥2, ≥3*, ≥4*  Progression to vision threatening complications  Central subfield thickness (CST)  Best Corrected Distance Visual Acuity (BCDVA)  Rescue subjects  DME fellow eye status  Safety and tolerability  Exploratory: Labs/PK  *Potential Phase 3 approvable endpoints  ZETA-1 Phase 2 Design – APX 3330 in DR  Randomized, Double-masked, Placebo-controlled 24-week Trial (Similar to Eylea P3 DR trial)  Endpoints  25 US sites  N = 90-100 participants with moderately severe to severe NPDR or mild PDR (DRSS 47, 53, 61)  Key inclusion:  ≥ 18 years of age  DRSS 47, 53, or 61  Noncentral DME permitted  ETDRS BCVA ≥ 60 letters (20/63)  Key exclusion:  OCT CST >320 µm2  Center involved DME allowed in fellow eye  Anti-VEGF within past 6 months3  HbA1c ≥ 12.0%  Eligibility Criteria  103 subjects enrolled (FPFV Apr 2021 to LPLV Aug 2022)  Topline announced in early 2023  1:1  By Central Reading Center  Center-Involved DME in Fellow Eye is Acceptable  Includes Systemic or IVT VEGF  www.clinicaltrials.gov (NCT04692688); Eylea® is registered trademark of Regeneron  NPDR = non-proliferative diabetic retinopathy PDR = proliferative diabetic retinopathy  12  Week 0  Week 12  Week 24  Week 4  Primary Endpoint  APX3330 600mg/day (BID)  Placebo BID  Randomization 
 

 Change in DRSS is Regulatory Approval Endpoint for DR  Local Drugs (Intravitreal Injections)  Systemic Drugs  Precedent approvable endpoint for locally- delivered drugs (Non-Systemic) in DR:  ≥ 2-step DRSS improvement in study eye  Aflibercept (PANORAMA trial)  Ranibizumab (RISE/RIDE/DRCR trials)  Potential approvable endpoints for systemic drug in DR (to be confirmed at the EOP2 FDA meeting) include:  ≥ 3-step binocular DRSS improvement  ≥ 3-step binocular DRSS worsening  End-of-Phase 2 meeting with FDA to align on binocular ≥ 3-step DRSS worsening (i.e., sum of right and left eye change in DRSS) as an acceptable primary endpoint for registration.  This endpoint is distinct from historical anti-VEGF IVT precedent due to different delivery  FDA accepts improvement OR worsening (prevention of progression)1 of the disease AND DRSS is an established surrogate endpoint for DR  13  Nair P, Aiello LP, Gardner TW, Jampol LM, Ferris FL III. Report From the NEI/FDA Diabetic Retinopathy Clinical Trial Design and Endpoints Workshop. Invest Ophthalmol Vis Sci. 2016 Oct 1;57(13):5127-5142. doi: 10.1167/iovs.16-20356. PMID: 27699406; PMCID: PMC6016432.  Source: ZETA-1 Clinical trial; Eylea® is registered trademark of Regeneron; Lucentis® is registered trademark of Roche/Genentech 
 

 Source: ZETA-1 Clinical Trial  Key Visual Metrics  APX3330 n=51  Placebo n=52  Total n=103  BCVA  Study Eye  Letters (mean)  81  78  80  (20/25  Snellen)  BCVA  Fellow Eye  Letters (mean)  76  77  77  (20/32  Snellen)  OCT CST  Study Eye  (µm)  270  271  271  OCT CST  Fellow Eye  (µm)  292  286  289  Intraretinal Fluid in the Center of SE  Y – 21  N – 26  Y – 12  N – 31  Y – 33  N – 57  Intraretinal Fluid at the Foveal Center of SE  Y – 1  N – 20  Y – 1  N – 41  Y – 2  N – 61  Intraocular Pressure in Study Eye (mmHg)  15  16  15  APX3330 n=51  Placebo n=52  DRSS Score – Study Eye  47 (Moderately severe to severe NPDR)  22 (43%)  18 (35%)  53 (Moderately severe to severe NPDR)  25 (49%)  28 (54%)  61 (Mild proliferative diabetic retinopathy)  4 (8%)  6 (12%)  DRSS Score – Fellow Eye  43 or Lower (Mild to moderate NDPR or better)  14 (31%)  12 (24%)  47 (Moderately severe to severe NPDR)  13 (29%)  19 (39%)  53   (Moderately severe to severe NPDR)  12 (27%)  9 (19%)  61 (Mild proliferative diabetic retinopathy)  1 (2%)  4 (8%)  65 or Higher (Moderate to severe prolif. DR)  5 (11%)  5 (10%)  Good Visual Acuity  Fluid Below 320µm  Note: 15 fellow eyes were CST>320 microns (center-involved DME eyes)  ZETA-1: Baseline Characteristics - Well-Balanced Across Arms  14  DRSS Scores 
 

 ZETA-1: % of Subjects with Binocular Improvement/Worsening in DRSS at Wk 24  APX3330 Demonstrated Statistical Efficacy on Potential Phase 3 Registration Endpoint  p=0.12  8%  p=0.04  16%  18%  35%  33%  33%  20%  6%  p=0.18  2%  0%  0%  11%  36% 36%  29%  18%  11%   9%   0%  5%  10%  15%  20%  25%  30%  35%  40%  ≥ 4 Steps  Worsening  ≥ 3 Steps  Worsening  ≥ 2 Steps  Worsening  ≥ 1 Steps  Worsening  No Change  ≥ 1 Step ≥ 2 Step ≥ 3 Step ≥ 4 Step  Improvement Improvement Improvement Improvement  Percent of Subjects (%)  Percent of Subjects With Binocular Improvement or Worsening in DRSS  of ≥ 1, ≥ 2, ≥ 3, and ≥ 4 Steps From Baseline (mITT-LOCF)  Placebo (n=49)  APX3330 (n=45)  15  Source: ZETA-1 Clinical Trial 
 

 ZETA-1: Percent of Subjects With Binocular ≥ 3-Step Worsening in DRSS  Primary Endpoint for Planned Phase 3 Demonstrates Prevention of Progression  12%  16%  0%  5%  10%  15%  20%  Week 12  Week 24  Percent of Subjects (%)  Visit  Placebo (N=49) APX3330 (N=46)  n=49  0%  n=45  0%  n=45  n=49  p=0.04  p=0.07  Percent of Subjects With Worsening in DRSS of ≥3 Steps From  Baseline by Visit Binocular Eyes (mITT-LOCF)  Based on extrapolation from ZETA-1 and Rise/Ride extension trials1, estimated ~25% of untreated patients may progress by ≥ 3 steps in binocular DRSS over 1 year  5%   19%   0%  5%  10%  15%  20%  25%  Placebo (n=43) APX3330 (n=40)  Treatment Group  % of Subjects  p=0.07  BCVA data shows function followed structure with fewer APX3330 treated subjects losing visual acuity compared to placebo at week 24  Percentage of Subjects with ≥ 5 Letters of BCVA Lost at Week 24  (Safety Population)  16  Source: ZETA-1 Clinical Trial  Sun JK, Evidence for DR Progression and Regression from Clinical Trials. Presented at NDI/FDA DR Clinical Trials Design and Endpoints Workshop, June 26, 2015.   Note: Images from Central Reading Center will be reviewed prior to EOP2 FDA meeting  Note: Large “N” indicates total number of participants within each arm for the mITT-LOCF population. Small “n” indicates total number of evaluable eyes for each respective endpoint and arm. 
 

 APX3330 SAEs: Dyskinesia, TIA, Chest pain  Placebo SAEs: Vertigo, Asthenia, Multiple organ dysfunction, Bradycardia, CAD  AEs → Withdrawal APX3330: Presyncope, Dyspnea; Placebo: DME (both eyes)  *Preferred Term within Organ Class  ZETA-1: Treatment Emergent Adverse Events  Oral APX3330 Showed a Favorable Safety Profile Consistent with Prior Trials  APX3330 (n=51)  Placebo (n=52)  Total (n=103)  Total AEs  91  120  211  # of Subjects with AEs  29 (57%)  35 (67%)  64 (62%)  Treatment Related AEs  14 (45%)  17 (55%)  31 (30%)  Serious AEs  3 (3%)  11 (9%)  14 (7%)  Subjects Withdrawals Due to AEs  2 (4%)  1 (2%)  3 (3%)  Deaths  0 (0%)  1 (2%)  1 (1%)  AEs in >5% of Subjects*  Diabetic Retinal Edema  2 (4%)  5 (10%)  7 (7%)  Diabetic Retinopathy  1 (2%)  6 (12%)  7 (7%)  Vitreous detachment  0 (0%)  3 (6%)  3 (3%)  Cataract  3 (6%)  1 (2%)  4 (4%)  Pruritus  6 (12%)  1 (2%)  7 (7%)  Rash  3 (6%)  1 (2%)  4 (4%)  COVID-19  1 (2%)  5 (10%)  6 (6%)  APX3330 Safety Profile:  Limited AEs, most mild in severity  AEs similar to or less than placebo (except for pruritis/rash)  Few serious treatment-related AEs, all unrelated to study medication  No ocular AEs other than expected DR progression  No effect on clinical labs  No adverse effects on heart, kidney, liver, CNS, GI  No effect on vital signs (HR, BP)  Patients continued routine medications to manage their diabetes comorbidities  | Eye disorders |  17 
 

 APX3330 - Phase 2 Summary and Next Steps  APX3330 is the most advanced oral program in development for diabetic eye disease  APX3330 demonstrated favorable safety with compelling potential to slow progression of diabetic retinopathy  ZETA-1 statistically significant results on potential Phase 3 registration endpoint:  0% APX3330-treated patients had a binocular ≥ 3-step worsening of DRSS from baseline compared with 16% for placebo-treated patients (p=0.04)  ZETA-1 Summary  Further analysis of ZETA-1 Phase 2 data, including insights for Phase 3 trial design  Prepare for EOP2 FDA meeting in 2H 2023 to formally confirm Phase 3 design and endpoints  Advance APX3330 into Phase 3 program  APX3330 Next Steps  To have a clinically meaningful impact on preventing progression to reduce likelihood of vision loss in diabetic retinopathy patients  Our Goals for Patients  18 
 

 19  Reversal of Mydriasis (RM)  P  DLD  Presbyopia  Dim Light or Night Vision Disturbances (DLD)  Nyxol as a Single Drop  Nyxol with LDP Adjunctive Therapy  1  0.4%  2  RM  RM  NYXOL®  EYE DROPS  THREE INDICATIONS  NEW PARTNERSHIP WITH VIATRIS 
 

 Decreases pupil size (moderately) without affecting the iris sphincter or ciliary muscles  Allows for 3 indications:  RM, Presbyopia and DLD  505(b)(2) Regulatory Pathway Supported by Prior Phentolamine Approvals in non-ophthalmic Indications  Nyxol’s Differentiated MOA as an Alpha-1 Blocker  No Engagement of Ciliary Muscle, No Headaches and Lower Risk of Retinal Detachment  Phentolamine is the Active Ingredient in Nyxol: a non-selective α1 Antagonist  Phentolamine blocks α1 receptors on the Iris Dilator Muscle up to 24 hours  20  Company websites. Illustration for educational purposes 
 

 *Trend toward statistical significance even in smaller POS arm from time 0 to time 6 hours (n=30); larger sample size for all arms planned in Phase 3 program  Primary Endpoint  Efficacy Data  Key Secondary Endpoint(s)  Safety & Tolerability  Return to baseline pupil diameter at 90 minutes after dilation  Met Phase 3 primary endpoint MIRA-3: 58% Nyxol vs. 6% placebo  MIRA-2: 49% Nyxol vs. 7% placebo (p<0.0001)  MIRA-4: 64% Nyxol vs. 25% placebo  Efficacy across all mydriatic agents, iris color, 1 or 2 drops, and all ages (3-80)  No headaches  No blurry vision  ~5% mild redness  No change in IOP  No SAEs  Most AEs were mild  ≥3 line gain in near vision with loss of no more than 1 line in distance vision  Met planned Phase 3 primary endpoint VEGA-1: 29% Nyxol vs.12% placebo at 12 hrs post-Nyxol dose  (p=0.02)  Durable near vision (18 hrs) Optimal pupil size Pupillary light reflex  Met Phase 2 primary endpoint  Met planned Phase 3 primary endpoint VEGA-1: 61% combo post-LDP dose (30 min) + post-Nyxol dose (12 hrs)  vs. 14% placebo (p<0.0001)  Durable near vision gain Optimal pupil size Pupillary light reflex  ≥3 lines (eye test) of improvement in mesopic low contrast best-corrected distance visual acuity (mLCVA)  Met Phase 3 primary endpoint LYNX-1: 13% Nyxol vs. 3% placebo at Day 8 (p<0.05) and 21% in Nyxol vs.3%  placebo at Day 15 (p<0.01)  Improvement visual acuity measures (distance and near) in dim light conditions  Summary of Nyxol Trial Results  Comprehensive Body of Clinical Data Supporting Efficacy and Safety Across 3 Indications  RM  P: Nyxol  DLD  21  Indication  RM  Presbyopia (Nyxol Alone)  Presbyopia (Nyxol + LDP)  DLD 
 

 Phase 2  Phase 1  Ocuphire  Nyxol + 0.4% pilo  Visus Brimochol® (carbachol + brim)  Other Cholinergic Agonists*  Cholinergic Agonist* (pilocarpine)  Lenz Aceclidine; Aceclidine + brim  Eyenovia  MicroLine (2% pilo)  Alpha Antagonist & low dose pilocarpine*  Alpha Antagonist  NDA  Allergan  VUITYTM;  (1.25% pilo)  Orasis  CSF-1 (Low dose pilo)  Phase 3  Nyxol’s potential differentiation:  New MOA class (iris dilator muscle inhibitor)  Favorable safety and tolerability (e.g.: no headaches, no accommodative spasm, no risk of retinal detachment)  24-hour durability  Broad range of patients including high myopes  Improvement in night vision disturbances  Nyxol+LDP may offer added efficacy and tunability  Ocuphire  Nyxol  (0.75% phentolamine)  Pupil modulation MOA  Combination drugs  Lens softening MOA  X  Novartis  EV-006  Lens Softening  * acts on sphincter and ciliary muscles in dose- dependent manner  22  Corporate Websites, Grzybowski, A, Markeviciute A, Zemaitiene R. A Review of Pharmacological Presbyopia Treatment. 2020  A New, Differentiated MOA and Combination Therapy Offers Tunability 
 

 Corporate Highlights  Two Lead Clinical-Stage Novel Drugs Addressing Multiple Large Ophthalmology Markets with Limited to No Competition & Extensive Patent Portfolio  Global License Agreement with Viatris to Fully Fund the Development and Commercialization of Nyxol for All Indications  Strong Financial Position to Advance APX and Nyxol Clinical Programs into 2025  Nyxol for RM Indication PDUFA Date on September 28, 2023  APX3330 – Paradigm changing oral for 8 million DR patients; Moving into Phase 3   APX3330 oral tablets  Diabetic Retinopathy/Diabetic Macular Edema (DR/DME)  Nyxol eyedrops  Reversal of Mydriasis (RM) – eye dilation  Presbyopia (P) – age-related blurry near vision  Dim Light or Night Vision Disturbances (DLD)  23 
 

 Restore Vision & Clarity  www.ocuphire.com ir@ocuphire.com  Ocuphire Pharma  Appendix:  Team and Nyxol Data  24 
 

 25  Drey ColemanVP, Clinical Operations  Amy Rabourn, CPA  SVP, Finance  Charlie Hoffmann, MBA  SVP, Corporate Development   Mitch Brigell, PhD  Head, Clinical Development   and Strategy  Daniela Oniciu​, PhD  Global Head, R&D, Chemistry  and Product Development  Ronil Patel, MS  SVP, Operations and BD  Chris Ernst  Global Head, QA  and Manufacturing  Barbara Withers, PhDVP, Clinical and Regulatory Strategy  Bindu Manne  Head, Market Development and Commercialization  Laura Gambino  Director, Project Management  Richard Rodgers, MBA  Interim CEO   Management Team with Decades of Drug Development Experience 
 

 Ocuphire's World-Class Medical Advisory Board  Chief Medical Advisor, Ocuphire Refractive Specialist  Jay Pepose, MD, PhD UCLA School of Medicine  Refractive Specialist  Y. Ralph Chu, MD Northwestern University  Refractive Specialist  Zaina Al-Mohtaseb, MD Baylor College of Medicine  Refractive Specialist James Katz, MD University of Illinois  Refractive Specialist Marguerite McDonald, MD Columbia University  Refractive Specialist  Mitch Jackson, MD University of Chicago  Refractive/ Glaucoma Specialist  Thomas Samuelson, MD  University of Minnesota  Refractive/Glaucoma Specialist  Inder Paul Singh, MD The Chicago Medical School  Eliot Lazar, MD Georgetown University  elCON Medical  Retinal Specialist Peter Kaiser, MD Harvard Medical School  Retinal Specialist  David Lally, MD Vanderbilt University  Retinal Specialist  Michael Allingham, MD, PhD University of North Carolina  Retinal Specialist  David Boyer, MD Chicago Medical School  Retinal Specialist David Brown, MD Baylor University  Retinal Specialist Jeffrey Heier, MD Boston University  Retinal Specialist  Anat Lowenstein, MD, PhD The Hebrew University  Retinal Specialist  Caroline Baumal, MD University of Toronto Medical School  Optometry  Douglas Devries, OD University of Nevada  Optometry  Paul Karpecki, OD Indiana University  Optometry  Justin Schweitzer, OD Pacific University College of Optometry  Optometry  Selina McGee, OD Northeastern State University  Optometry  Leslie O’Dell, OD Salus University  Co-Founder Apexian/APX3330  Mark Kelley, PhD Indiana University  26 
 

 Ocuphire Board of Directors  Seasoned Directors with Decades of Drug Development, M&A/Financings, and Ophthalmology  27  Sean Ainsworth, MBA  Lead Independent Director,   Board Director ​  Jay Pepose, MD, PhD  Board Director  Cam Gallagher, MBA  Chair, Board Director  Mina Sooch, MBA  Board Director   Susan Benton, MBA  Board Director​  James Manuso, PhD/MBA  Board Director​  Richard Rodgers, MBA  Interim President & CEO   Board Director