2023 Q2 Form 10-Q Financial Statement

#000162828023016011 Filed on May 05, 2023

View on sec.gov

Income Statement

Concept 2023 Q2 2023 Q1 2022 Q4
Revenue $0.00 $0.00 $0.00
YoY Change
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $9.564M $8.193M $6.937M
YoY Change -9.41% -19.03% -7.14%
% of Gross Profit
Research & Development $14.17M $9.558M $17.21M
YoY Change 57.31% 20.76% 142.37%
% of Gross Profit
Depreciation & Amortization $174.0K $174.0K $173.0K
YoY Change 93.33% 128.95% 121.79%
% of Gross Profit
Operating Expenses $23.73M $17.75M $24.15M
YoY Change 21.3% -1.57% 65.73%
Operating Profit -$23.73M -$17.75M
YoY Change 21.3% -1.57%
Interest Expense $500.0K $700.0K
YoY Change 400.0%
% of Operating Profit
Other Income/Expense, Net $808.0K $1.253M $2.211M
YoY Change 759.57% 8253.33% 8403.85%
Pretax Income -$22.93M -$16.50M -$21.94M
YoY Change 17.74% -8.44% 50.46%
Income Tax $0.00
% Of Pretax Income
Net Earnings -$22.93M -$16.50M -$21.94M
YoY Change 17.74% -8.44% 50.46%
Net Earnings / Revenue
Basic Earnings Per Share -$0.10 -$0.07
Diluted Earnings Per Share -$0.10 -$0.07 -$0.10
COMMON SHARES
Basic Shares Outstanding 226.4M shares 226.4M shares 218.9M shares
Diluted Shares Outstanding 238.3M shares 225.5M shares

Balance Sheet

Concept 2023 Q2 2023 Q1 2022 Q4
SHORT-TERM ASSETS
Cash & Short-Term Investments $70.60M $76.72M $90.93M
YoY Change -38.61% -40.88% -4.24%
Cash & Equivalents $70.60M $68.26M $77.56M
Short-Term Investments $0.00 $8.462M $13.37M
Other Short-Term Assets $2.874M $7.680M $7.558M
YoY Change -62.0% -6.98% -1.69%
Inventory
Prepaid Expenses
Receivables
Other Receivables
Total Short-Term Assets $73.45M $84.40M $98.49M
YoY Change -40.07% -38.85% -4.05%
LONG-TERM ASSETS
Property, Plant & Equipment $11.72M $7.952M $6.053M
YoY Change 271.71% 313.95% 420.02%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $3.804M $3.946M $4.087M
YoY Change -12.87% 142.38% 127.06%
Total Long-Term Assets $15.52M $11.90M $10.14M
YoY Change 106.46% 221.57% 225.52%
TOTAL ASSETS
Total Short-Term Assets $73.45M $84.40M $98.49M
Total Long-Term Assets $15.52M $11.90M $10.14M
Total Assets $88.98M $96.30M $108.6M
YoY Change -31.6% -32.05% 2.71%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $3.881M $8.092M $8.062M
YoY Change -34.45% 107.7% 248.7%
Accrued Expenses $8.313M $6.335M $9.900M
YoY Change 102.61% 79.11% 128.9%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due $1.266M $1.256M $0.00
YoY Change
Total Short-Term Liabilities $13.46M $15.68M $18.46M
YoY Change 30.2% 104.02% 163.71%
LONG-TERM LIABILITIES
Long-Term Debt $1.472M $1.058M $2.289M
YoY Change -15.89% -38.88% 33.7%
Other Long-Term Liabilities $455.0K $309.0K $244.0K
YoY Change -88.31% -73.81% -80.18%
Total Long-Term Liabilities $5.235M $4.816M $6.120M
YoY Change -7.21% 65.44% 107.95%
TOTAL LIABILITIES
Total Short-Term Liabilities $13.46M $15.68M $18.46M
Total Long-Term Liabilities $5.235M $4.816M $6.120M
Total Liabilities $18.70M $20.50M $24.58M
YoY Change 16.99% 93.42% 147.21%
SHAREHOLDERS EQUITY
Retained Earnings -$252.4M -$229.5M -$213.0M
YoY Change 49.17% 53.31% 61.77%
Common Stock $2.566M $2.265M $2.217M
YoY Change 18.63% 4.96% 11.13%
Preferred Stock
YoY Change
Treasury Stock (at cost) $48.00K $48.00K $48.00K
YoY Change 0.0% 0.0% 0.0%
Treasury Stock Shares
Shareholders Equity $70.28M $75.80M $84.05M
YoY Change
Total Liabilities & Shareholders Equity $88.98M $96.30M $108.6M
YoY Change -31.6% -32.05% 2.71%

Cashflow Statement

Concept 2023 Q2 2023 Q1 2022 Q4
OPERATING ACTIVITIES
Net Income -$22.93M -$16.50M -$21.94M
YoY Change 17.74% -8.44% 50.46%
Depreciation, Depletion And Amortization $174.0K $174.0K $173.0K
YoY Change 93.33% 128.95% 121.79%
Cash From Operating Activities -$18.81M -$18.24M -$16.91M
YoY Change 36.3% 21.07% 32.1%
INVESTING ACTIVITIES
Capital Expenditures $2.777M $1.612M $2.024M
YoY Change -303.29% 622.87% -1154.17%
Acquisitions
YoY Change
Other Investing Activities $8.500M $5.053M -$13.27M
YoY Change
Cash From Investing Activities $5.723M $3.441M -$15.29M
YoY Change -518.96% -1643.05% 7866.15%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 15.40M $5.496M 8.175M
YoY Change 6427.12% -89.03% 1251.24%
NET CHANGE
Cash From Operating Activities -18.81M -$18.24M -16.91M
Cash From Investing Activities 5.723M $3.441M -15.29M
Cash From Financing Activities 15.40M $5.496M 8.175M
Net Change In Cash 2.321M -$9.304M -24.03M
YoY Change -115.55% -126.73% 93.96%
FREE CASH FLOW
Cash From Operating Activities -$18.81M -$18.24M -$16.91M
Capital Expenditures $2.777M $1.612M $2.024M
Free Cash Flow -$21.58M -$19.85M -$18.94M
YoY Change 73.62% 29.84% 50.16%

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CY2021Q4 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalents
95109000 usd
CY2023Q1 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalents
68259000 usd
CY2022Q1 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalents
129922000 usd
CY2023Q1 us-gaap Capital Expenditures Incurred But Not Yet Paid
CapitalExpendituresIncurredButNotYetPaid
1119000 usd
CY2022Q1 us-gaap Capital Expenditures Incurred But Not Yet Paid
CapitalExpendituresIncurredButNotYetPaid
611000 usd
CY2023Q1 ocgn Noncash Or Part Noncash Amount Of Equity Issuance Costs
NoncashOrPartNoncashAmountOfEquityIssuanceCosts
0 usd
CY2022Q1 ocgn Noncash Or Part Noncash Amount Of Equity Issuance Costs
NoncashOrPartNoncashAmountOfEquityIssuanceCosts
71000 usd
CY2023Q1 us-gaap Nature Of Operations
NatureOfOperations
Nature of Business<div style="margin-top:12pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">Ocugen, Inc., together with its wholly owned subsidiaries ("Ocugen" or the "Company"), is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. The Company is headquartered in Malvern, Pennsylvania, and manages its business as one operating segment.</span></div><div style="margin-top:12pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:700;line-height:120%">Modifier Gene Therapy Platform</span></div><div style="margin-top:12pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">The Company is developing a modifier gene therapy platform designed to fulfill unmet medical needs related to retinal diseases, including inherited retinal diseases ("IRDs"), such as retinitis pigmentosa ("RP"), Leber congenital amaurosis ("LCA"), and Stargardt disease, as well as dry age-related macular degeneration ("AMD") with a single mutation-agnostic therapy. The Company's modifier gene therapy platform is based on the use of nuclear hormone receptors ("NHRs"), which have the potential to restore homeostasis — the basic biological processes in the retina. Unlike single-gene replacement therapies, which only target one genetic mutation, the Company believes that its modifier gene therapy platform, through its use of NHRs, represents a novel approach that has the potential both to address multiple retinal diseases caused by mutations in multiple genes with a single unique product and to address complex diseases that are potentially caused by imbalances in multiple gene networks.</span></div><div style="margin-top:12pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">The Company believes that OCU400 has the potential to be broadly effective in restoring retinal integrity and function across a range of genetically diverse IRDs, including RP and LCA. OCU400 has received Orphan Drug Designation ("ODD") from the United States Food and Drug Administration ("FDA") and Orphan Medicinal Product Designation ("OMPD") from the European Commission ("EC") for the treatment of RP and LCA.</span></div><div style="margin-top:12pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">The Company is conducting a Phase 1/2 trial to assess the safety and efficacy of unilateral subretinal administration of OCU400 in patients with nuclear receptor subfamily 2 group E member 3 ("</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:120%">NR2E3") </span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">and rhodopsin (</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:120%">"RHO</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">"</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:120%">)</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">-related RP and centrosomal protein 290 ("</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:120%">CEP290</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">"</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:120%">)</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">-related LCA in the United States. The Company has completed dosing patients with RP in the dose-escalation portion of the trial, which enrolled 10 patients to receive a low, medium, or high dose of OCU400 in the subretinal space. Additionally, the Company has completed dosing eight patients with RP in the dose-expansion portion of the trial and is continuing to enroll patients with LCA to receive the high dose, which was determined to be the maximum tolerable dose from the dose-escalation portion of the trial. In April 2023, the Company announced positive preliminary data among RP patients treated in the first two cohorts of the Phase 1/2 trial. In Cohorts 1 and 2 of the trial, seven participants with severe vision impairment due to RP associated with the </span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:120%">RHO</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%"> and </span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:120%">NR2E3</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%"> gene mutations received a unilateral subretinal injection of either a low dose or a medium dose of OCU400, respectively. The preliminary results showed a favorable safety profile and visual improvements after treatment with OCU400 as measured by multi-luminance mobility testing ("MLMT") and best corrected visual acuity assessment ("BCVA"). In March 2023, the FDA approved the enrollment of pediatric patients in the ongoing Phase 1/2 trial for the treatment of RP and LCA and the Company intends to dose pediatric patients in the second quarter of 2023. Additionally, the Company intends to initiate a Phase 3 trial for OCU400 for the treatment of RP and LCA near the end of 2023, subject to discussions with the FDA.</span></div><div style="margin-top:12pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">The Company is also developing OCU410 and OCU410ST, utilizing the nuclear receptor genes RAR-related orphan receptor A ("</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:120%">RORA</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">"</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:120%">),</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%"> for the treatment of dry AMD and Stargardt disease, respectively. OCU410 is a potential one-time, curative therapy with a single sub-retinal injection. OCU410ST has received ODD from the FDA for the treatment of </span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:120%">ABCA4</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">-associated retinopathies, including Stargardt disease. The Company intends to submit Investigational New Drug ("IND") applications in the second quarter of 2023 to initiate Phase 1/2 trials.</span></div><div style="margin-top:12pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:700;line-height:120%">Regenerative Medicine Cell Therapy Platform</span></div><div style="margin-top:12pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">NeoCart is a Phase 3-ready, regenerative medicine cell therapy technology that combines breakthroughs in bioengineering and cell processing to enhance the autologous cartilage repair process. NeoCart is a three-dimensional tissue-engineered disc of new cartilage that is manufactured by growing chondrocytes, the cells responsible for maintaining cartilage health. The chondrocytes are derived from the patient on a unique scaffold. In this therapy, healthy cartilage tissue is grown and implanted in the patient. Cartilage defects often lead to osteoarthritis if left untreated. Current surgical and nonsurgical treatment options are limited in their efficacy and durability. NeoCart has the potential to accelerate healing, reduce pain, and provide regenerative native-like </span></div><div style="margin-top:12pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">cartilage strength with durable benefits post transplantation. The FDA granted a regenerative medicine advanced therapy ("RMAT") designation to NeoCart for the repair of full-thickness lesions of knee cartilage injuries in adults. Additionally, the Company received concurrence from the FDA on the confirmatory Phase 3 trial design. The Company is renovating an existing facility into a current Good Manufacturing Practice ("GMP") facility in accordance with the FDA's regulations in support of NeoCart manufacturing for personalized Phase 3 trial material. The Company intends to initiate the Phase 3 trial in 2024.</span></div><div style="margin-top:12pt"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:700;line-height:120%">Vaccines</span></div><div style="margin-top:12pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">The Company's vaccines platform is driven by its conviction to serve a public health concern, which requires the endorsement and support of government funding, both domestically and in licensed territories abroad, in order to develop and ultimately commercialize its vaccine candidates. Therefore, the Company's anticipated expenses for vaccines development from the second quarter of 2023 onward will be limited as it devotes its current cash, cash equivalents, and investments to developing its modifier gene therapy platform. The Company is refocusing its efforts to develop an inhalation-based, next generation mucosal vaccine platform to overcome the limitations of current intramuscular COVID-19 treatments, namely sustained durability and transmissibility inhibition. While the Company continues to incur expenses for the development of its inhaled mucosal vaccine platform to achieve IND readiness, any additional development will be reliant on government funding.</span></div><div style="margin-top:12pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:120%">Inhaled Mucosal Vaccines</span></div><div style="margin-top:12pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">The Company is developing a novel inhaled mucosal vaccine platform, which includes OCU500, a bivalent COVID-19 vaccine; OCU510, a seasonal quadrivalent flu vaccine; and OCU520, a combination quadrivalent seasonal flu and bivalent COVID-19 vaccine. As these vaccine candidates are being developed to be administered through inhalation, the Company believes they have the potential to generate rapid local immunity in the upper airways and lungs where viruses enter and infect the body, which the Company believes may help reduce or prevent infection and transmission as well as provide protection against new virus variants. The Company intends to submit an IND application near the end of 2023 or in early 2024 and is continuing to work closely with government agencies to obtain funding for the development of these inhaled mucosal vaccines.</span></div><div style="margin-top:12pt"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:120%">Intramuscular COVID-19 Vaccine</span></div><div style="margin-top:12pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">In April 2023, the FDA announced the cancellation of emergency use authorizations ("EUA") issued to monovalent vaccines and the simplification of the vaccination schedule of bivalent vaccines that have EUAs in the United States. Accordingly, the Company has determined it is not commercially viable to continue the development of COVAXIN in its North American territory and consequently, will focus its efforts on the development of the inhaled mucosal bivalent vaccines.</span></div><div style="margin-top:12pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:700;line-height:120%">Novel Biologic Therapy for Retinal Diseases</span></div><div style="margin-top:12pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">The Company is developing OCU200, which is a novel fusion protein containing parts of human transferrin and tumstatin. OCU200 is designed to treat diabetic macular edema ("DME"), diabetic retinopathy ("DR"), and wet AMD. The Company has completed the technology transfer of manufacturing processes to its contract development and manufacturing organization ("CDMO") and has produced trial materials to initiate a Phase 1 trial. The Company submitted an IND application to the FDA in February 2023 to initiate a Phase 1 trial targeting DME. In April 2023, the FDA placed the Company's IND application for the Phase 1 trial on clinical hold as part of the FDA's request for additional information related to chemistry, manufacturing, and controls ("CMC") prior to initiating the Phase 1 trial. The Company intends to work with the FDA and provide requested information as promptly as possible, and does not currently expect the clinical hold to impact the anticipated overall timing of the OCU200 clinical development program.</span></div><div style="margin-top:12pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:700;line-height:120%">Going Concern</span></div><div style="margin-top:12pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">The Company has incurred recurring net losses since inception and has funded its operations to date through the sale of common stock, warrants to purchase common stock, the issuance of convertible notes and debt, and grant proceeds. The Company incurred net losses of approximately $16.5 million and $18.0 million for the three months ended March 31, 2023 and 2022, respectively. As of March 31, 2023, the Company had an accumulated deficit of $229.5 million and cash, cash equivalents, and investments totaling $76.7 million. This amount will not meet the Company's capital requirements over the next 12 months. The Company believes that its cash, cash equivalents, and investments will enable it to fund its operations into the first quarter of 2024. Due to the inherent uncertainty involved in making estimates and the risks associated with the research, development, and commercialization of biotechnology products, the Company may have based this estimate on assumptions that may prove to be wrong, and the Company's operating plan may change as a result of many factors currently unknown to the Company.</span></div><div style="margin-top:12pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">The Company is subject to risks, expenses, and uncertainties frequently encountered by companies in its industry. The Company intends to continue its research, development, and commercialization efforts for its product candidates, which will require significant additional funding. If the Company is unable to obtain additional funding in the future and/or its research, development, and commercialization efforts require higher than anticipated capital, there may be a negative impact on the financial viability of the Company. The Company plans to fund its operations through public and private placements of equity and/or debt, payments from potential strategic research and development arrangements, sales of assets, licensing and/or collaboration arrangements with pharmaceutical companies or other institutions, funding from the government, particularly for the development of the Company's novel inhaled mucosal vaccine platform, or funding from other third parties. Such financing and funding may not be available at all, or on terms that are favorable to the Company. While Company management believes that it has a plan to fund operations, its plan may not be successfully implemented. Failure to generate sufficient cash flows from operations, raise additional capital, or appropriately manage certain discretionary spending, could have a material adverse effect on the Company's ability to achieve its intended business objectives.</span></div><div style="margin-top:12pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">As a result of these factors, together with the anticipated increase in spending that will be necessary to continue to research, develop, and commercialize the Company's product candidates, there is substantial doubt about the Company's ability to continue as a going concern within one year after the date that these condensed consolidated financial statements are issued. The condensed consolidated financial statements do not contain any adjustments that might result from the resolution of any of the above uncertainties.</span></div>
CY2023Q1 us-gaap Number Of Operating Segments
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CY2023Q1 us-gaap Net Income Loss
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CY2022Q1 us-gaap Net Income Loss
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CY2023Q1 us-gaap Use Of Estimates
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<div style="margin-top:12pt"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:700;line-height:120%">Use of Estimates</span></div><div style="margin-top:12pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">In preparing the condensed consolidated financial statements in conformity with GAAP, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported amounts of expenses during the reporting period. Due to the inherent uncertainty involved in making estimates, actual results reported in future periods may be affected by changes in these estimates. On an ongoing basis, the Company evaluates its estimates and assumptions. These estimates and assumptions include those used in the accounting for research and development contracts, including clinical trial accruals, and the fair value measurement of equity instruments.</span></div>
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CY2022Q1 us-gaap Cash And Cash Equivalents At Carrying Value
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CY2022Q1 us-gaap Restricted Cash Noncurrent
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CY2022Q1 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents
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<div style="margin-top:12pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:700;line-height:120%">Concentration of Credit Risk</span></div><div style="margin-top:12pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">Financial instruments that potentially subject the Company to significant concentrations of credit risk consist of cash, cash equivalents, and investments. The Company's cash, cash equivalents, and investments are held in accounts at financial institutions that may exceed federally insured limits. The Company has not experienced any credit losses in such accounts and does not believe it is exposed to significant credit risk beyond the standard credit risk associated with commercial banking relationships.</span></div>
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P2Y
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CY2023Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Grants In Period Gross
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CY2023Q1 us-gaap Share Based Compensation Arrangements By Share Based Payment Award Options Grants In Period Weighted Average Exercise Price
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CY2023Q1 us-gaap Share Based Compensation Arrangements By Share Based Payment Award Options Exercises In Period Weighted Average Exercise Price
ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsExercisesInPeriodWeightedAverageExercisePrice
0.42
CY2023Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Forfeitures And Expirations In Period
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsForfeituresAndExpirationsInPeriod
628119 shares
CY2023Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Forfeitures And Expirations In Period Weighted Average Exercise Price
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsForfeituresAndExpirationsInPeriodWeightedAverageExercisePrice
2.88
CY2023Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Number
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumber
13724164 shares
CY2023Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Weighted Average Exercise Price
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice
2.53
CY2023Q1 us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Options Outstanding Weighted Average Remaining Contractual Term2
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsOutstandingWeightedAverageRemainingContractualTerm2
P8Y6M
CY2023Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Intrinsic Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingIntrinsicValue
599000 usd
CY2023Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Exercisable Number
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableNumber
5199957 shares
CY2023Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Exercisable Weighted Average Exercise Price
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableWeightedAverageExercisePrice
2.92
CY2023Q1 us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Options Exercisable Weighted Average Remaining Contractual Term1
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsExercisableWeightedAverageRemainingContractualTerm1
P7Y8M12D
CY2023Q1 us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Options Exercisable Intrinsic Value1
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsExercisableIntrinsicValue1
322000 usd
CY2023Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Grants In Period Weighted Average Grant Date Fair Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageGrantDateFairValue
1.01
CY2022Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Grants In Period Weighted Average Grant Date Fair Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageGrantDateFairValue
3.61
CY2023Q1 us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Options Vested In Period Fair Value1
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsVestedInPeriodFairValue1
5600000 usd
CY2022Q1 us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Options Vested In Period Fair Value1
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsVestedInPeriodFairValue1
2800000 usd
CY2023Q1 us-gaap Net Income Loss
NetIncomeLoss
-16498000 usd
CY2022Q1 us-gaap Net Income Loss
NetIncomeLoss
-18019000 usd
CY2023Q1 us-gaap Weighted Average Number Of Diluted Shares Outstanding
WeightedAverageNumberOfDilutedSharesOutstanding
225523627 shares
CY2023Q1 us-gaap Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
225523627 shares
CY2022Q1 us-gaap Weighted Average Number Of Diluted Shares Outstanding
WeightedAverageNumberOfDilutedSharesOutstanding
205693498 shares
CY2022Q1 us-gaap Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
205693498 shares
CY2023Q1 us-gaap Earnings Per Share Diluted
EarningsPerShareDiluted
-0.07
CY2023Q1 us-gaap Earnings Per Share Basic
EarningsPerShareBasic
-0.07
CY2022Q1 us-gaap Earnings Per Share Diluted
EarningsPerShareDiluted
-0.09
CY2022Q1 us-gaap Earnings Per Share Basic
EarningsPerShareBasic
-0.09
CY2023Q1 us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
18557017 shares
CY2022Q1 us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
18964943 shares

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