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): February 28, 2023
___________________________________________________________
(Exact Name of Registrant as Specified in its Charter)
___________________________________________________________
| (State or Other Jurisdiction of Incorporation) | (Commission File Number) | (I.R.S. Employer Identification Number) | ||||||||||||
(484 ) 328-4701
(Address, including zip code, and telephone number, including area code, of principal executive office)
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):
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||
(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 ☐
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 2.02 Results of Operations and Financial Condition.
On February 28, 2023, Ocugen, Inc. (the "Company") issued a press release announcing its financial results for the fourth quarter and the fiscal year ended December 31, 2022. The Company has scheduled a conference call and webcast for 8:30 a.m. eastern time on February 28, 2023 to discuss these financial results and business updates. The Company will use presentation materials in connection with the conference call and webcast, which presentation materials will be posted on the Company's website at www.ocugen.com. Copies of the press release and presentation materials are furnished herewith as Exhibit 99.1 and Exhibit 99.2, respectively, to this Current Report on Form 8-K and incorporated herein by reference.
The information disclosed under Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1 and Exhibit 99.2, is being furnished 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, and shall not be deemed to be incorporated by reference in any Company 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.
The following exhibits are being furnished herewith:
(d) Exhibits
| Exhibit No. | Document | |||||||
| 99.1 | ||||||||
| 99.2 | ||||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |||||||
1
SIGNATURE
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.
Date: February 28, 2023
| OCUGEN, INC. | ||||||||
| By: | /s/ Shankar Musunuri | |||||||
| Name: Shankar Musunuri | ||||||||
| Title: Chief Executive Officer and Chairman | ||||||||
2
Exhibit 99.1
Ocugen Provides Business Update with Fourth Quarter and Full Year 2022 Financial Results
Conference Call and Webcast Today at 8:30 a.m. ET
•Completed retinitis pigmentosa patient enrollment in OCU400 Phase 1/2 clinical trial
•Continued progress for programs targeting eye diseases with the submission of an IND application for OCU200
•Expanded portfolio now includes inhaled vaccines for COVID-19, seasonal flu, and a combination COVID-19+seasonal flu vaccine
MALVERN, Pa., Feb. 28, 2023 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today reported fourth quarter and full year 2022 financial results along with a general business update.
“We continue to grow and advance as a diversified biotechnology organization as reflected in our accomplishments of 2022,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen. “Our pipeline has been expanded to appropriately address the current challenges and gaps in the fight against COVID-19, application of OCU410 to address Stargardt (a rare eye disease), and our novel approach to address dry age-related macular degeneration (dAMD)—a disease affecting vision in over 266 million people worldwide.
“Following FDA concurrence in the fourth quarter of 2022 on a confirmatory Phase 3 clinical trial design for NeoCart®, we are developing internal capabilities to move our regenerative medicine asset, NeoCart®, into the clinic next year.”
“The FDA has granted expanded orphan drug designations to OCU400 for the treatment of retinitis pigmentosa (RP) and Leber congenital amaurosis (LCA),” said Dr. Musunuri. “These broad, gene-agnostic designations are encouraging at this stage in the development of OCU400.”
“During our first decade, we have built a strong foundation for addressing the diseases and conditions we aim to treat. We delivered on our promise to file an OCU200 IND in the first quarter of 2023 and look forward to delivering on important milestones in 2023, especially regarding preliminary efficacy data for gene therapy product OCU400, as we progress toward realizing our long-term vision to address unmet medical needs through courageous innovation,” Dr. Musunuri concluded.
Business Updates
Ophthalmic Gene Therapies
•OCU400 — Established the high dose as the maximum tolerable dose, completed retinitis pigmentosa patient enrollment, and continuing to enroll patients with LCA to receive the high dose. Ocugen intends to initiate a Phase 3 clinical trial near the end of 2023.
•OCU410 and OCU410ST — Executing IND-enabling studies and intend to submit IND applications in the second quarter of 2023 to initiate Phase 1/2 clinical trials in dry AMD (geographic atrophy) and Stargardt disease.
Ophthalmic Biologic Product
•OCU200 — Submitted an IND application on February 27, 2023 to initiate a Phase 1 clinical trial targeting diabetic macular edema.
Regenerative Cell Therapies
•NeoCart® — Received concurrence from the FDA on the confirmatory Phase 3 clinical trial design. Ocugen intends to initiate the Phase 3 clinical trial in the first half of 2024. Ocugen is renovating its facility to accommodate cGMP manufacturing of NeoCart® for clinical trials and beyond.
Vaccines Portfolio
•OCU500 Series — Developing a novel mucosal vaccine platform which includes OCU500, a bivalent COVID-19 inhaled vaccine; OCU510, a seasonal quadrivalent flu inhaled vaccine; and OCU520 a combination quadrivalent seasonal flu and bivalent COVID-19 inhaled vaccine.
•COVAXIN™ (BBV152) — Completed enrollment in Phase 2/3 immuno-bridging and broadening clinical trial in fourth quarter 2022.
Financial Results
•Fourth quarter — Research and development expenses for the three months ended December 31, 2022, were $17.2 million compared to $7.1 million for the three months ended December 31, 2021. General and administrative expenses for the three months ended December 31, 2022, were $6.9 million compared to $7.5 million for the three months ended December 31, 2021. Ocugen reported a $0.10 net loss per common share for the three months ended December 31, 2022, compared to a $0.07 net loss per common share for the three months ended December 31, 2021.
•Full year — Research and development expenses for the year ended December 31, 2022, were $49.8 million compared to $35.1 million for the year ended December 31, 2021. General and administrative expenses for the year ended December 31, 2022, were $35.1 million compared to $22.9 million for the year ended December 31, 2021. Ocugen reported a $0.38 net loss per common share for the year ended December 31, 2022, compared to a $0.30 net loss per common share for the year ended December 31, 2021.
•Ocugen’s cash, cash equivalents, restricted cash, and investments totaled $90.9 million as of December 31, 2022, compared to $95.1 million as of December 31, 2021. The Company estimates that its current cash, cash equivalents, and investments will enable it to fund its operations into the first quarter of 2024. The Company had 221.6 million shares of common stock outstanding as of December 31, 2022.
Conference Call and Webcast Details
Ocugen has scheduled a conference call and webcast for 8:30 a.m. ET today to discuss the financial results and recent business highlights. Ocugen’s senior management team will host the call, which will be open to all listeners. There will also be a question-and-answer session following the prepared remarks.
Attendees are invited to participate on the call or webcast using the following details:
Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers
Conference ID: 8912239
Webcast: Available on Ocugen’s investor site
A replay of the call and archived webcast will be available for approximately 45 days following the event on the Ocugen investor site.
About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking
statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.
Contact:
Tiffany Hamilton
Head of Communications
IR@ocugen.com
(Tables to follow)
OCUGEN, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands)
(Unaudited)
As of December 31, | |||||||||||
| 2022 | 2021 | ||||||||||
| Assets | |||||||||||
| Current assets | |||||||||||
| Cash and cash equivalents | $ | 77,563 | $ | 94,958 | |||||||
| Marketable securities | 13,371 | — | |||||||||
| Prepaid expenses and other current assets | 7,558 | 7,688 | |||||||||
| Total current assets | 98,492 | 102,646 | |||||||||
| Property and equipment, net | 6,053 | 1,164 | |||||||||
| Restricted cash | — | 151 | |||||||||
| Other assets | 4,087 | 1,800 | |||||||||
| Total assets | $ | 108,632 | $ | 105,761 | |||||||
| Liabilities and stockholders' equity | |||||||||||
| Current liabilities | |||||||||||
| Accounts payable | $ | 8,062 | $ | 2,312 | |||||||
| Accrued expenses and other current liabilities | 9,900 | 4,325 | |||||||||
| Operating lease obligations | 498 | 363 | |||||||||
| Total current liabilities | 18,460 | 7,000 | |||||||||
| Non-current liabilities | |||||||||||
| Operating lease obligations, less current portion | 3,587 | 1,231 | |||||||||
| Long term debt, net | 2,289 | 1,712 | |||||||||
| Other non-current liabilities | 244 | — | |||||||||
| Total liabilities | 24,580 | 9,943 | |||||||||
| Stockholders' equity | |||||||||||
| Convertible preferred stock | 1 | 1 | |||||||||
| Common stock | 2,217 | 1,995 | |||||||||
| Treasury stock | (48) | (48) | |||||||||
| Additional paid-in capital | 294,874 | 225,537 | |||||||||
| Accumulated other comprehensive income | 26 | — | |||||||||
| Accumulated deficit | (213,018) | (131,667) | |||||||||
| Total stockholders' equity | 84,052 | 95,818 | |||||||||
| Total liabilities and stockholders' equity | $ | 108,632 | $ | 105,761 | |||||||
OCUGEN, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)
(Unaudited)
| Three months ended December 31, | Year ended December 31, | ||||||||||||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
| Operating expenses | |||||||||||||||||||||||
| Research and development | $ | 17,213 | $ | 7,102 | $ | 49,757 | $ | 35,108 | |||||||||||||||
| General and administrative | 6,937 | 7,470 | 35,111 | 22,920 | |||||||||||||||||||
| Total operating expenses | 24,150 | 14,572 | 84,868 | 58,028 | |||||||||||||||||||
| Loss from operations | (24,150) | (14,572) | (84,868) | (58,028) | |||||||||||||||||||
| Other income (expense), net | 2,211 | (9) | 3,517 | (389) | |||||||||||||||||||
| Loss before income taxes | (21,939) | (14,581) | (81,351) | (58,417) | |||||||||||||||||||
| Income tax benefit | — | — | — | (52) | |||||||||||||||||||
| Net loss | $ | (21,939) | $ | (14,581) | $ | (81,351) | $ | (58,365) | |||||||||||||||
| Shares used in calculating net loss per common share — basic and diluted | 220,072,823 | 199,207,502 | 214,600,051 | 195,013,043 | |||||||||||||||||||
| Net loss per common share — basic and diluted | $ | (0.10) | $ | (0.07) | $ | (0.38) | $ | (0.30) | |||||||||||||||
Q4 & Full Year 2022 Business Update February 28, 2023 NASDAQ:OCGN
2 This presentation contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this presentation speak only as of the date of this presentation. Except as required by law, we assume no obligation to update forward-looking statements contained in this presentation whether as a result of new information, future events, or otherwise, after the date of this presentation. Forward-Looking Statements
3 Vaccines COVAXINTM Completed enrollment in Phase 2/3 clinical trial OCU500 Series Developing an inhaled vaccine platform for the prevention of COVID-19 & flu Gene Therapies OCU400 Completed retinitis pigmentosa patient enrollment Completed dose- escalation of the Phase 1/2 clinical trial Established high dose as maximum tolerable dose OCU410 & OCU410ST Executing IND-enabling studies Cell Therapies NeoCart® Received concurrence from the FDA on the confirmatory Phase 3 clinical trial design cGMP facility for manufacturing NeoCart® clinical trial material under construction OCU200 Submitted an IND application for a Phase 1 clinical trial targeting diabetic macular edema Biologics Accomplishments –2022 & YTD
FDA granted expanded Orphan Drug Designations for all retinitis pigmentosa (RP) and Leber congenital amaurosis (LCA) mutations Despite its prevalence, RP and LCA patients have limited treatment options • US: RP & LCA affect 110K and 15K people, respectively • Worldwide: conditions affect approximately 1.6M people Current approved and in-development gene therapies focus on individual gene • More than 125 mutated genes associated with RP and LCA • Developing a single therapy to treat each mutation is infeasible OCU400 addresses shortcomings of current gene therapy approaches • Broad-spectrum, gene-agnostic approach to genetically diverse inherited retinal diseases • Therapy with a single sub-retinal injection, using NHRs Dose escalation and recruitment of RP patients completed • High dose established as Maximum Tolerable Dose (MTD) • Continue to enroll patients with LCA • Intend to initiate a Phase 3 trial near the end of 2023. 4 Nuclear Hormone Receptors (NHRs): intracellular receptors that regulate gene expression, acting as a master regulator of genes in the retina. OCU400: Phase 1/2 Clinical Trial Progressing as Planned, Developing a Novel Gene Therapy in Ophthalmic Areas of High Unmet Need
5 OCU200: Submitted an IND with the US FDA Yesterday to Initiate a Phase 1 Clinical Trial Targeting Diabetic Macular Edema (DME) OCU200 is our novel biologics candidate for sight-threatening conditions • A recombinant fusion protein of tumstatinand transferrin • Potential to address diabetic macular edema (DME), diabetic retinopathy (DR), wet AMD High prevalence of DME, DR and wet AMD patients • DME: 21M worldwide • DR: 162M worldwide • Wet AMD: 30M worldwide Limited treatment options available for the above patients • Current therapies target only one pathway, either angiogenesis or inflammation • Up to 50% of patient populations experience limited or no response to current treatments OCU200 potentially addresses shortcomings of current treatments • Intended to targetsmultiple causative pathways such as angiogenesis, oxidation, inflammation • Potential to offer better treatment options for all patients Company submitted an IND application on February 27, 2023 • Initially targeting DME Diabetic Macular Edema: bulges protrude from the blood vessels, leading to leakage of fluid and blood into the retina; leakage results in swelling (or “edema”), promoting vision loss.
6 NeoCart®: US FDA Agreed to Proposed Control and Overall Design for Phase 3 Trial to Evaluate Safety and Efficacy Compared to Chondroplasty Standard of Care *The Journal of Bone & Joint Surgery: June 1, 2011 - Volume 93 - Issue 11 - p 994-1000 **https://www.biospace.com/article/cell-therapy-market-size-cagr-trends-forecast-report-2022-2030/ NeoCart is a regenerative cell therapy technology • Combines bioengineering and cell processing to enhance autologous cartilage repair • Potential to accelerate healing and reduce pain through reconstructing damaged knee cartilage High prevalence of knee cartilage damage, with progression to osteoarthritis (OA) • Arthroscopic knee procedures: over 1M annually* • OA: 528M diagnosed worldwide • Cell therapy global revenue forecast: $45B+, with North America expected to hold largest share** Current therapies to treat cartilage damage in the knee suboptimal • Varying outcomes due to variable cellular responses • Current standard of care suffers from one or more of the following: pain, reduced knee function, failure to address cartilage damage, donor tissue availability, open surgery NeoCart potentially addresses shortcomings of current treatments • Treat pain at the source, improve function and potentially prevent progression to OA • Potential for improved efficacy, long-term benefits, accelerated discovery, predictable outcomes Program advancing on several fronts • Received FDA concurrence on confirmatory trial design of Phase 3 (initiate 1H2024) • Renovating facility to accommodate cGMP manufacturing for clinical trials
7 OCU500 Series: Next-Generation Vaccine Candidates Using Inhalation Technology to Potentially Overcome Durability and Transmission Challenges OCU500 A bivalent COVID-19 vaccine OCU510 A seasonal quadrivalent flu vaccine OCU520 A combination quadrivalent flu and bivalent COVID19 vaccine COVID-19 and flu infections continue to be a public health concern • COVID-19: 1M+ US cases in the last 30 days; 5M+ WW cases with 47K deaths in the last 28 days • Flu: 50%+ of U.S. population 6-months and older received a shot for the 2022 to 2023 flu season, totaling 170M doses Limitations of current COVID-19 vaccines • Lack of durability: immunity wanes significantly over time, requiring repeated boosters • Inability to stop transmission: breakthrough infections prevalent, increasing potential for mutations Inhalation vaccine advantages • Potential to generate rapid mucosal immunity in respiratory pathways, limiting infection and transmission • COVID-19 preclinical studies demonstrated vaccine induced high neutralizing and effector responses
8 COVAXIN™(BBV152): Final Data and Analysis Expected Mid-Year 2023 for Our Injectable COVID-19 Vaccine Enrollment completed for Phase 2/3 immuno-bridging and broadening clinical trial in December 2022 Topline data highlights, reported in January 2023, include the following: • Safety: well-tolerated with no related serious adverse events (no thrombotic, myocarditis, pericarditis cases) • Efficacy: immunogenicity demonstrated • Final data and analysis: anticipated mid-year 2023
9 OCU500 series NeoCart® OCU400 OCU410/410ST OCU200 Q1 Q2 Q3 Q4 IND filing to initiate clinical trials cGMP facility completion Initiation of Phase 3 clinical trial IND submissions: Phase 1/2 clinical trials in dry AMD & Stargardt disease Dosing of patients in Phase 1 clinical trial Preliminary data 2023: Several Significant Milestones Expected Preliminary efficacy data
Financial Update 10
Statement of Operations Three months ended December 31, Year ended December 31, 2022 2021 2022 2021 Research and development expense $17.2 $7.1 $49.8 $35.1 General and administrative expense 6.9 7.5 35.1 22.9 Other income (expense), net 2.2 — 3.5 (0.4) Net loss $(21.9) $(14.6) $(81.4) $(58.4) Net loss per share of common stock — basic and diluted $(0.10) $(0.07) $(0.38) $(0.30) Balance Sheet Data As of December 31, 2022 2021 Cash, cash equivalents, restricted cash, and investments $90.9 $95.1 Debt $2.3 $1.7 Shares outstanding 221.6 199.4 Unaudited; in millions, except per share amounts 11 Financial Update
Questions & Answers 12
February 2023 NASDAQ:OCGN Thankyou!