Full Press Release Details
INOVIO Reports First Quarter 2024 Financial Results and Recent Business Highlights
PLYMOUTH MEETING, PA May 13, 2024 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 its financial results for the first quarter of 2024 and provided an update on recent company
In the first quarter of 2024, we continued to deliver on our priorities for the year. Of utmost importance, we remain on track to
submit our BLA in the second half of 2024 under the accelerated approval pathway for INO-3107 as a treatment for RRP and are working to initiate our confirmatory trial as soon as possible based on feedback
from the FDA on the trial s design. We are energized by the opportunity to potentially deliver the first FDA-approved therapy for this devastating disease and continue to work expeditiously to be prepared
to serve RRP patients and the physicians caring for them. If approved, INO-3107 would also be the first DNA medicine on the market in the United States, representing a major milestone for our technology
platform, said Dr. Jacqueline Shea, INOVIO s President and Chief Executive Officer. In parallel, we also made progress with our plans to evaluate INO-3112 in combination with the PD-1 inhibitor, LOQTORZI, in a Phase 3 trial, as we believe the combination could address a substantial unmet need in patients with locoregionally advanced, high-risk,
HPV-16/18 positive OPSCC, a type of head and neck cancer commonly known as throat cancer. We believe that we are aligned with the FDA on our proposed Phase 3 trial design, and we now plan to discuss these
plans with European regulators. We look forward to sharing our continued progress throughout the year.
Recent Business Highlights
INO-3107 Recurrent Respiratory Papillomatosis (RRP)
INO-3112 Oropharyngeal Squamous Cell Carcinoma (OPSCC)
First Quarter 2024 Financial Results
INOVIO s balance sheet and statement of operations are provided below. Additional information is included in INOVIO s
quarterly report on Form 10-Q for the quarter ended March 31, 2024, which can be accessed at: http://ir.inovio.com/financials/default.aspx.
INOVIO estimates its cash runway,
including the net proceeds of the April 2024 underwritten registered direct offering, to extend into the third quarter of 2025. This projection includes an operational net cash burn estimate of approximately $30 million for the second quarter
of 2024. These cash runway projections do not include any further capital-raising activities that INOVIO may undertake.
Conference Call / Webcast
INOVIO s management will host a live conference call and webcast with slides at 4:30 p.m. ET today to discuss INOVIO s financial
results and provide a general business update. The live webcast and replay may be accessed by visiting INOVIO s website at
About INOVIO s DNA Medicines Platform
DNA medicines platform has two innovative components: precisely designed DNA plasmids, delivered by INOVIO s proprietary investigational medical device, CELLECTRA . INOVIO uses
proprietary technology to design its DNA plasmids, which are small circular DNA molecules that work like software the body s cells can download to produce specific proteins to target and fight disease. INOVIO s proprietary CELLECTRA delivery devices are designed to optimally deliver its DNA medicines to the body s cells without requiring chemical adjuvants or lipid nanoparticles and without the risk of the anti-vector
response historically seen with viral vector platforms.
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 technology optimizes the design and delivery of innovative DNA medicines that teach the body to manufacture its own disease-fighting tools.
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 clinical trials and the availability and timing of data from those trials, the planned submission of a BLA in the second half of 2024,
plans for discussions with regulatory authorities, the planned commercial launch of INO-3107 if regulatory approval is obtained, and expectations with respect to our cash resources through the third quarter of
2025 and expected cash burn for the second quarter of 2024. 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,
2023, our Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, 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, 2024 | December 31, 2023 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 19,601,829 | $ | 14,310,862 | ||||
| Short-term investments | 86,013,044 | 130,982,913 | ||||||
| Accounts receivable from affiliated entities | 2,551,082 | 2,405,228 | ||||||
| Prepaid expenses and other current assets | 3,517,081 | 5,393,665 | ||||||
| Prepaid expenses and other current assets from affiliated entities | 20,432 | |||||||
| Total current assets | 111,683,036 | 153,113,100 | ||||||
| Fixed assets, net | 5,015,067 | 4,960,986 | ||||||
| Investment in affiliated entity | 2,654,269 | 2,780,287 | ||||||
| Operating lease right-of-use assets | 9,156,478 | 9,491,735 | ||||||
| Other assets | 605,315 | 605,315 | ||||||
| Total assets | $ | 129,114,165 | $ | 170,951,423 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 16,675,922 | $ | 19,847,744 | ||||
| Accounts payable and accrued expenses due to affiliated entity | 1,525,079 | 1,070,519 | ||||||
| Accrued clinical trial expenses | 3,022,486 | 2,365,382 | ||||||
| Operating lease liability | 2,155,540 | 2,406,522 | ||||||
| Grant funding liability | 87,489 | |||||||
| Grant funding liability from affiliated entity | 21,918 | 21,918 | ||||||
| Convertible senior notes | 16,770,654 | |||||||
| Total current liabilities | 23,400,945 | 42,570,228 | ||||||
| Operating lease liability, net of current portion | 11,271,257 | 11,032,066 | ||||||
| Total liabilities | 34,672,202 | 53,602,294 | ||||||
| Stockholders equity: | ||||||||
| Preferred stock | ||||||||
| Common stock | 23,370 | 22,792 | ||||||
| Additional paid-in capital | 1,748,529,814 | 1,740,954,074 | ||||||
| Accumulated deficit | (1,653,435,007 | ) | (1,622,965,136 | ) | ||||
| Accumulated other comprehensive loss | (676,214 | ) | (662,601 | ) | ||||
| Total Inovio Pharmaceuticals, Inc. stockholders equity | 94,441,963 | 117,349,129 | ||||||
| Total liabilities and stockholders equity | $ | 129,114,165 | $ | 170,951,423 |
Inovio Pharmaceuticals, Inc.
CONSOLIDATED STATEMENTS OF OPERATIONS
| Three Months Ended March 31, | ||||||||
| 2024 | 2023 | |||||||
| Revenue from collaborative arrangements and other contracts | $ | $ | 114,943 | |||||
| Operating expenses: | ||||||||
| Research and development | 20,913,790 | 30,176,511 | ||||||
| General and administrative | 10,571,179 | 13,890,610 | ||||||
| Total operating expenses | 31,484,969 | 44,067,121 | ||||||
| Loss from operations | (31,484,969 | ) | (43,952,178 | ) | ||||
| Other income (expense): | ||||||||
| Interest income | 1,500,290 | 2,207,171 | ||||||
| Interest expense | (177,833 | ) | (313,488 | ) | ||||
| (Loss) gain on investment in affiliated entity | (126,018 | ) | 616,639 | |||||
| Net unrealized gain on available-for-sale equity securities | 500,877 | 3,218,215 | ||||||
| Other expense, net | (682,218 | ) | (2,425,676 | ) | ||||
| Net loss | $ | (30,469,871 | ) | $ | (40,649,317 | ) | ||
| Net loss per share | ||||||||
| Basic and diluted (1) | $ | (1.31 | ) | $ | (1.89 | ) | ||
| Weighted average number of common shares outstanding | ||||||||
| Basic and diluted (1) | 23,291,512 | 21,536,476 |