8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 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): October 3, 2019

OCUGEN, INC.

(Exact Name of Registrant as Specified in its Charter)

Delaware	001-36751	04-3522315
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(I.R.S. Employer Identification Number)

5 Great Valley Parkway, Suite 160

Malvern, Pennsylvania 19355

(484) 328-4701

(Addresses, including zip code, and telephone numbers, including area code, of principal executive offices)

N/A

(Former Name or Former Address, if Changed Since Last Report)

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 (see General Instruction A.2. below):

o            Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o            Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o            Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o            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, $0.01 par value per share	OCGN	The Nasdaq Stock Market LLC (The Nasdaq Capital Market)

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. o

Item 7.01      Regulation FD Disclosure

Attached as Exhibit 99.1 and furnished for purposes of Regulation FD is a presentation that Ocugen, Inc. will post on its website on October 3, 2019 and may use from time to time in presentations or discussions with investors, analysts and other parties.

The information in this Item 7.01 (including Exhibit 99.1) is being furnished solely to satisfy the requirements of Regulation FD and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that Section, nor shall it be deemed to be incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act.

Item 9.01      Financial Statements and Exhibits

The following exhibits are being filed herewith:

(d) Exhibits

Exhibit No.	Document
99.1	Ocugen, Inc. Presentation

2

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: October 3, 2019

OCUGEN, INC.
By:	/s/ Shankar Musunuri
	Name:	Shankar Musunuri
	Title:	Chief Executive Officer and Chairman

3

EX-99.1

Exhibit 99.1

Developing Innovative Therapies to Address Rare Diseases and Underserved NASDAQ: OCGN Eye Corporate Deck

Forward Looking Statement This presentation contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this presentation, including statements regarding our business strategy, future results of operations and financial position, prospective products, product approvals, research and development costs, timing and likelihood of success, estimated market size or growth, and plans and objectives of management for future operations, are forward-looking statements. When used in this presentation, the words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements involve known and unknown risks, uncertainties and other factors, including those risks set forth in the Company’s filings with the Securities and Exchange Commission, which are available at www.sec.gov, that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements are based on our management’s beliefs and assumptions and on information available to management as of the date of this presentation. Our actual future results may be materially different from what we expect. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. This presentation includes estimates by us of statistical data relating to market size and growth and other estimated 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. This presentation also includes statistical and other industry and market data that we obtained from industry publications and research, surveys and studies conducted by third parties. Industry publications and third-party research, surveys and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. While we believe these industry publications and third-party research, surveys and studies are reliable, we have not independently verified such data. This communication shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended. 2 ©2019 Ocugen. All Rights Reserved.

Company Highlights Nasdaq-listed company as of September 30, 2019 Robust IP portfolio with 31 issued U.S. and foreign patents and 29 U.S. and foreign patent applications Strategic Partnership with CanSinoBIO for OCU400 Gene Therapy Co-Development & Manufacturing • • • 3 ©2019 Ocugen. All Rights Reserved. SMALL MOLECULE PHASE 3 RARE DISEASE ASSET OCU300 for ocular Graft Versus Host Disease (oGVHD) Orphan Drug Designation MODIFIER GENE THERAPY PLATFORM OCU400 for Inherited Retinal Diseases – Orphan Drug Designations (NR2E3 and CEP290 Mutation-Associated Retinal Diseases) OCU410 Dry AMD NOVEL BIOLOGIC THERAPIES FOR RETINAL DISEASES OCU200 for Wet AMD, Diabetic Macular Edema, Diabetic Retinopathy OCU100 for Retinitis Pigmentosa

Experienced Leadership Team • • • Diverse experience in large pharma, signature biotech, and small companies Track record of success Brings large and small company learnings to Ocugen 4 ©2019 Ocugen. All Rights Reserved. Rasappa Arumugham, PhD Chief Scientific Officer Vijay Tammara, PhD Vice President, Regulatory & Quality Kelly Beck, MBA Vice President, Investor Relations & Administration Daniel Jorgensen, MD, MPH, MBA Chief Medical Officer Sanjay Subramanian, MBA Chief Financial Officer Shankar Musunuri, PhD, MBA Chairman, CEO and Co-Founder

Orphan us oGVHD OCU300 NR2f3 Mutation-Associated Retinal Degeneration Orphan us CfP290 Mutation-Associated Retinal Degeneration Orphan us OCU400 NIVI-?-AAV Rhodopsin Mutation-Associated Retinal Degeneration OCU410 RO!<-IMV DryAMD > WetAMD > OCU200 tiiTl ld.l " • Tr no;,f<'p·in Diabetic Macular Edema > Diabetic Retinopathy OCU100 Retinitis Pigmentosa ®. ocugen ®2019 Ocugen.AII Rights Reserved. RETINAL DISEASES (novel biologics) MODIFIER GENE THERAPY PLATFORM OCULAR SURFACE DISEASE (small molecule) Phase 3 Phase 2 Phase 1 Preclinical Indication

OCU300 for oGVHD: Unmet Need for Patients with Ocular Graft vs Host Disease (oGVHD) Rare Ocular Diseases ~60% of chronic graft vs. host disease patients will develop oGVHD • Autoimmune disease that occurs in allogeneic bone marrow transplant patients –Donor derived leukocytes attack recipient ocular tissue Patients encounter dry, tearless eyes, vision issues, severe pain, discomfort, and potential ocular scarring May lead to significant vision loss and irreparable ocular surface damage Significantly diminishes quality of life and restricts daily activities ~63,000 patients in the US by 2020 • • • 6 ©2019 Ocugen. All Rights Reserved. Source: Prevalence of Hematopoietic Cell Transplant Survivors in the United States, Majhail N et al Oct 2014 Ocugen is the first and only company to receive orphan drug designation from FDA for treatment of oGVHD

First Phase 3 Study With Orphan Drug Designation Indication: Treatment of ocular discomfort and ocular redness in patients with oGVHD • • • Randomized, Double-Masked, Placebo-Controlled, Phase 3 Study 84-day study Key inclusion criteria: diagnosis of ‘definite’ oGVHD using the International Chronic Ocular GVHD Consensus Group revised diagnostic criteria (Ogawa, 2013) 2:1 randomization (OCU300 n=40; Placebo n=20) Sign: Ocular redness based on Validated Bulbar Redness (VBR) Score Primary endpoints include: • Symptom: Ocular discomfort based on Visual Analog Scale (VAS) On a scale from 0-10, what was the intensity of your Ocular Discomfort, at its worst, over the past 24 hours? • 7 ©2019 Ocugen. All Rights Reserved. 60 PATIENTS Planned sample size re-estimation OCUO3C0U0300 (Brimonidine 0.18% OcuNanoE™) PLAPCLEABCOE*BO (Ophthalmic Buffered Saline)

OcuNanoETM Formulation Drug Delivery System Increases OCU300 Concentration in Lacrimal Gland Mouse DED Model (Preclinical) Brimonidine Level in Lacrimal Gland (Preclinical) ** 1 0 0 0 4 3 1 0 0 2 1 1 0 0 0 3 6 9 1 2 O C U 3 0 0 B r i m o n i d i n e T im e ( h ) Drug distribution to lacrimal gland from traditional eye drops is low relative to other target tissues T M O C U 3 0 0 ( 0 . 1 8 % ) O c u N a n o E B r i m o n i d i n e s o l u t i o n ( 0 . 2 % ) • • • OCU300 = Brimonidine (0.18%) OcuNanoE™ Brimonidine = Commercial 0.2% solution Figure shows median, interquartile range & min/max fluorescein score **p<0.01 • 8 ©2019 Ocugen. All Rights Reserved. C o r n e a l F l u o r e s c e i n S c o r e M e a n ( S D ) T i s s u e C o n c e n t r a t i o n ( n g / g ) OcuNanoE™ increases brimonidine in lacrimal gland and improves overall efficacy of OCU300

OCU300 has Compelling Value Proposition Market Access Market Potential Physicians Patients • Spend 3 months in hospital after receiving bone marrow transplant • Potential to be first approved product in US market • Most exhibit symptoms while still under hematologist/ oncologist care • First and only company to receive Orphan Drug Designation from FDA for oGVHD • On multiple prescription therapies; hematologist options today limited and suboptimal (artificial tears or approved dry eye products) • Advances in hematopoietic cell transplantation leading to increasing number of transplant survivors 9 ©2019 Ocugen. All Rights Reserved. • Hematologists/Oncologists are first prescribers, then referred to specialized ophthalmologists • Hematologists looking for approved therapy; no knowledge of off-label options • Off-label usage primarily occurs when no approved therapy exists; long-term risks associated with tolerability and damage to ocular tissues • Therapies need to address ocular discomfort (pain) and redness – unmet need • No approved therapy • Seek to establish ICD-10 diagnostic code • Analysis supports premium pricing • Opportunities to partner for commercialization

Modifier Gene Therapy Has a Broader Impact Modifier Gene Therapy: Introduce a functional gene to modify the expression of many genes, gene-networks and reset homeostasis. Modifier gene Gene Augmentation: Transfer functional version of a non-functional gene into the target cells. Normal gene X Cell with mutated/ nonfunctioning gene X Cell with mutated/nonfunctioning gene(s) other than modifier gene Cell with normal function 10 ©2019 Ocugen. All Rights Reserved. •Novel approach that targets nuclear hormone genes (NHRs), which regulate multiple functions within the retina •Smoother regulatory pathway due to ability to target multiple diseases with one product •Ability to recoup development costs over multiple therapeutic indications •Traditional approach that targets one individual gene mutation at a time •Regulatory pathway focused on specific product for one disease •Longer time to recoup development costs Gene X Gene X Gene X Gene X Gene M Gene X Gene X Gene X Gene M Gene X

OCU400 Rescues Vision Loss in Multiple Retinal Diseases Human Disease: PDE6B associated RP Mouse Rhodopsin associated adRP Rho-/-Rhodopsin associated adRP RhoP23 H Enhanced S-cone syndrome rd7-/-PDE associated arRP rd10-/-Leber Congenital Amaurosis Cep290 (rd16) rd1-/-Models: ^ *Treated fundus photos: subretinal single injection Control Retinal Degeneration Mice Models ^rd16 is another name for CEP290 model rd7 is NR2E3 mutation 11 ©2019 Ocugen. All Rights Reserved. Untreated Treated* In multiple mouse models, Treatment Rescues Disease after onset

OCU400: Orphan Drug Designation NR2E3 Mutation-Associated Retinal Degeneration Early stage disease OCU400 Single Injection (Intravitreal) 1 mo Baseline (Control) 1 mo after treatment Advanced stage disease OCU400 Single Injection (Intravitreal) 3 mo Baseline (Control) 1 mo after treatment 3 mo Baseline (Control) 1 mo after treatment OCU400 Single Injection (Subretinal) rd7 mouse model 12 ©2019 Ocugen. All Rights Reserved.

OCU400 Gene Therapy Manufacturing: Strategic Partnership with CanSinoBIO CanSinoBIO • • • Publicly-listed on Hong Kong exchange (6185.HK) Biotech Company with market cap of approximately $1B State-of-the-art facilities with world class team CanSinoBIO to perform CMC development & manufacturing of clinical supplies • CanSinBIO responsible for all associated costs • Option for commercial manufacturing agreement CanSinoBIO has rights to develop, manufacture and commercialize OCU400 for Greater China market 13 ©2019 Ocugen. All Rights Reserved. Partnership paves a path for Ocugen to advance OCU400 into the clinic with significantly reduced capital and resources

Lead Biologic OCU200: Tumstatin-Transferrin Fusion Protein Offering Benefits Beyond Anti-VEGF In-Vitro Laser-Induced Rat CNV Model In-Vivo Laser-Induced Mouse CNV Model 8 0 6 0 4 0 PBS Tumstatin OCU200 Avastin V e h i c l e E y le a O C U 2 0 0 O C U 2 0 0 + E y l e a * indicates p<0.05 when compared to PBS and/or tumstatin treatment. † indicates p<0.05 when compared to bevacizumab; CNV lesions measured on day 14 after treatment. Data expressed as percentage of CNV lesions on Day 10 after treatment. Laser induction & treatment start on Day 0. 14 ©2019 Ocugen. All Rights Reserved. L e a k y C N V l e s i o n s ( % ) OCU200 Demonstrated Superior Efficacy with Potentially Fewer Injections in Head-to-Head Studies Selectively works on active endothelial cells Activates native anti-angiogenic response Targeting element enhances effective concentration Pro-apoptotic and anti-oxidative Inhibits new blood vessel formulation Reduces damage to retina

Summary of Near-Term Milestones OCU300 ocular GVHD (small molecule) OCU200 Wet AMD, DME, DR (novel biologic) •  Dec 2018: First Patient Dosed 2019-2020: Continue IND-Enabling Studies • 1H2020: Sample Size re-estimation • 2021: Target Phase 1/2a Clinical Trial • 2H2020: Estimated Topline Results of First Study Note: Check mark () denotes completed milestone. All other milestones are anticipated future milestones. 15 ©2019 Ocugen. All Rights Reserved. Feb 2019: Pre-IND Meeting Feb 2019: ODD for NR2E3 Mutation-Associated Retinal Diseases Aug 2019: ODD for CEP290 Mutation-Associated Retinal Diseases Sept 2019: CanSinoBIO Co-Development & Manufacturing Partnership • 2019-2020: Continue IND-Enabling Studies • 2021: Target Phase 1/2a Clinical Trial OCU400 (NR2E3-AAV) Retinal Degenerative Diseases (gene therapy)

Contact Kelly Beck Vice President, Investor Relations & Administration kelly.beck@ocugen.com 16 ©2019 Ocugen. All Rights Reserved.