Full Press Release Details
INOVIO Reports First Quarter 2023
Financial Results and Operational Highlights
PLYMOUTH MEETING, PA May 10, 2023 INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to
help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced financial results and operational highlights for the first quarter of 2023. INOVIO s management
will host its quarterly conference call and webcast today at 4:30 p.m. EDT. The live webcast and replay may be accessed by visiting INOVIO s website at
In the first quarter of 2023 we made solid progress with several key pipeline candidates, including
important headway in our development plans for INO-3107, our DNA medicine candidate for the treatment of RRP, said INOVIO s President and Chief Executive Officer, Dr. Jacqueline Shea.
From our ongoing discussions, we believe we are in alignment with the FDA on several critical design elements for our planned Phase 3 program for INO-3107, as we continue to work through a number of
their questions. Additionally, we were also encouraged to receive a positive opinion from the European Committee for Orphan Medicinal Products on our application for orphan drug designation for INO-3107. The
final determination is now with the European Commission, which will decide on our application this month. We believe the committee s opinion is another step in the right direction for the development of this candidate on a global basis.
Dr. Shea continued: Since our last quarterly report, INOVIO has presented at several scientific and medical conferences, including
presentations by lead investigators from our RRP and Ebola booster studies sharing important new immunological and safety data that shows the immense potential and versatility of our candidates. At the same time, we continued our focus on
operational excellence, taking steps to build upon the strong team we have in place by the hiring of Dr. Cheryl Elder as Senior Vice President of Regulatory Affairs. Cheryl s considerable regulatory expertise and track record of
successfully bringing products through licensure will help us implement efficient regulatory strategies as we work to advance our promising candidates through development and the regulatory approval process.
Organizational and Clinical Highlights
INO-3107 Recurrent Respiratory Papillomatosis (RRP)
INO-4201 Ebola Booster for ERVEBO
VGX-3100 High-Grade Squamous Intraepithelial Lesions (HSIL)
Strengthened Product Development Team
Data Presentations & Publications
During and following the quarter, INOVIO presented, published, or submitted data from several of its clinical programs:
INOVIO plans to continue to submit papers and abstracts related to its research for publication and presentation as data becomes available to various journals
and medical conferences. Further details will be shared upon acceptance for publication.
First Quarter 2023 Financial Results
Conference Call / Webcast Information
management will host its quarterly conference call and webcast at 4:30 p.m. ET today. A replay of the conference call will be available following the conclusion of the call. The live webcast and replay may be accessed by visiting INOVIO s
INOVIO is a biotechnology company focused
on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases. INOVIO s DNA medicines in development are delivered using its
investigational proprietary smart device, CELLECTRA , to produce immune responses against targeted pathogens and cancers. For more information, visit www.inovio.com.
Media: Jennie Willson (267) 429-8567 jennie.willson@inovio.com
Investors: Thomas Hong (267) 440-4298 thomas.hong@inovio.com
Forward-Looking Statements
This press release contains
certain forward-looking statements relating to our business, including our plans to develop and commercialize DNA medicines and our expectations regarding our research and development programs, including the planned initiation and conduct of pre-clinical studies and clinical trials and the availability and timing of data from those studies and trials, and expectations with respect to our cash resources and expected operating expenses into the first
quarter of 2025. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials,
product development programs and commercialization activities and outcomes, the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or
develop viable DNA medicines, our ability to support our pipeline of DNA medicine products, the ability of our collaborators to attain development and commercial milestones for products we license and product sales that will enable us to receive
future payments and royalties, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by us or collaborators, including alternatives that may be more
efficacious or cost effective than any therapy or treatment that we and our collaborators hope to develop, issues involving product liability, issues involving patents and whether they or licenses to them will provide us with meaningful protection
from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether we can finance or devote other
significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of our technology by potential corporate or other partners or collaborators, capital market conditions, the impact of
government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2022, our Quarterly Report on Form
10-Q for the quarter ended March 31, 2023, and other filings we make from time to time with the Securities and Exchange Commission. There can be no assurance that any product candidate in our pipeline
will be successfully developed, manufactured, or commercialized, that the results of clinical trials will be supportive of regulatory approvals required to market products, or that any of the forward-looking information provided herein will be
proven accurate. Forward-looking statements speak only as of the date of this release, and we undertake no obligation to update or revise these statements, except as may be required by law.
INOVIO Pharmaceuticals, Inc.
CONSOLIDATED BALANCE SHEETS
| March 31, 2023 | December 31, 2022 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 28,238,152 | $ | 46,329,359 | ||||
| Short-term investments | 195,513,005 | 206,669,397 | ||||||
| Accounts receivable | 73,304 | 1,701,726 | ||||||
| Accounts receivable from affiliated entities | 4,961,802 | 10,036,490 | ||||||
| Prepaid expenses and other current assets | 4,914,313 | 50,130,481 | ||||||
| Prepaid expenses and other current assets from affiliated entities | 195,853 | 375,227 | ||||||
| Total current assets | 233,896,429 | 315,242,680 | ||||||
| Fixed assets, net | 6,983,305 | 7,727,997 | ||||||
| Investment in affiliated entity | 2,623,781 | 2,007,142 | ||||||
| Intangible assets, net | 2,047,778 | 2,129,861 | ||||||
| Goodwill | 10,513,371 | 10,513,371 | ||||||
| Operating lease right-of-use assets | 9,865,543 | 10,228,207 | ||||||
| Other assets | 652,517 | 684,044 | ||||||
| Total assets | $ | 266,582,724 | $ | 348,533,302 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 24,752,171 | $ | 79,686,885 | ||||
| Accounts payable and accrued expenses due to affiliated entities | 1,417,274 | 1,220,439 | ||||||
| Accrued clinical trial expenses | 5,795,846 | 10,594,073 | ||||||
| Operating lease liability | 2,579,949 | 2,803,973 | ||||||
| Grant funding liability | 4,121,989 | 2,475,031 | ||||||
| Grant funding liability from affiliated entity | 89,007 | 87,673 | ||||||
| Convertible senior notes | 16,394,841 | |||||||
| Total current liabilities | 55,151,077 | 96,868,074 | ||||||
| Convertible senior notes | 16,614,840 | |||||||
| Operating lease liability, net of current portion | 12,185,919 | 12,655,586 | ||||||
| Deferred tax liabilities | 32,046 | 32,046 | ||||||
| Total liabilities | 67,369,042 | 126,170,546 | ||||||
| Stockholders equity: | ||||||||
| Preferred stock | ||||||||
| Common stock | 262,738 | 253,090 | ||||||
| Additional paid-in capital | 1,728,030,842 | 1,710,656,191 | ||||||
| Accumulated deficit | (1,528,497,101 | ) | (1,487,847,784 | ) | ||||
| Accumulated other comprehensive loss | (582,797 | ) | (698,741 | ) | ||||
| Total Inovio Pharmaceuticals, Inc. stockholders equity | 199,213,682 | 222,362,756 | ||||||
| Total liabilities and stockholders equity | $ | 266,582,724 | $ | 348,533,302 |
INOVIO Pharmaceuticals, Inc.
CONSOLIDATED STATEMENTS OF OPERATIONS
| Three Months Ended March 31, | ||||||||
| 2023 | 2022 | |||||||
| Revenue from collaborative arrangements and other contracts | $ | 114,943 | $ | 199,074 | ||||
| Operating expenses: | ||||||||
| Research and development | 30,176,511 | 55,978,611 | ||||||
| General and administrative | 13,890,610 | 15,953,458 | ||||||
| Total operating expenses | 44,067,121 | 71,932,069 | ||||||
| Loss from operations | (43,952,178 | ) | (71,732,995 | ) | ||||
| Other income (expense): | ||||||||
| Interest income | 2,207,171 | 669,814 | ||||||
| Interest expense | (313,488 | ) | (313,488 | ) | ||||
| Gain (loss) on investment in affiliated entity | 616,639 | (537,728 | ) | |||||
| Net unrealized gain (loss) on available-for-sale equity securities | 3,218,215 | (4,840,641 | ) | |||||
| Other expense, net | (2,425,676 | ) | (153,468 | ) | ||||
| Net loss before share in net loss of Geneos | (40,649,317 | ) | (76,908,506 | ) | ||||
| Share in net loss of Geneos | (2,165,213 | ) | ||||||
| Net loss | $ | (40,649,317 | ) | $ | (79,073,719 | ) | ||
| Net loss per share | ||||||||
| Basic and diluted | $ | (0.16 | ) | $ | (0.36 | ) | ||
| Weighted average number of common shares outstanding | ||||||||
| Basic and diluted | 258,437,714 | 218,940,693 |