Full Press Release Details
INOVIO Announces Second Quarter 2023 Financial Results and Provides Strategic Update
Preparing to initiate pivotal Phase 3 trial of INO-3107 in adult RRP patients in first quarter of
2024; INO-3107 received Orphan Drug Designation from European Commission in second quarter
Scaling resources and headcount to align with strategic focus on INO-3107 and late-stage clinical
candidates closest to market and with greatest opportunity to deliver on the promise of DNA medicines for patients
biomarker analysis from REVEAL2, INOVIO is stopping investment in VGX-3100 for cervical HSIL for U.S. market; Remains committed to supporting partner ApolloBio s
non-biomarker strategy for Chinese market
$194.9 million in cash, cash equivalents and
short-term investments at quarter end; Headcount reduction and reallocation of resources expected to lower future cash burn and extend cash runway into third quarter of 2025
Investor call today at 4:30 PM EDT
PLYMOUTH MEETING, Pa., August 9, 2023 /PRNewswire/ 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 second quarter ended June 30,
2023 and provided a strategic update.
We continue to make progress with INO-3107, our candidate for the
treatment of recurrent respiratory papillomatosis (RRP). Following positive results from our Phase 1/2 trial earlier this year, we are pleased to announce that we are targeting to have the first patient dosed in a Phase 3 trial in adults in the
first quarter of 2024, moving us one step closer to delivering on the promise of DNA medicines for patients suffering from this debilitating disease, said Dr. Jacqueline Shea, INOVIO s President and Chief Executive Officer.
Based on our interactions with the U.S. Food and Drug Administration (FDA) we believe that we have an acceptable trial design. We are addressing what we believe to be their final questions before we commence our pivotal Phase 3 trial for
As we move forward with our pipeline, we are focused on making sure our company is scaled for success in light of the
challenging funding environment, particularly for pre-commercial biotech companies like INOVIO, Dr. Shea continued. With that in mind, we made the difficult decision to further reduce our
headcount and operational spending to better align with our strategic priorities. We believe that with the pipeline reprioritization announced today, we are well-positioned to execute on our development plans for
INO-3107 while also advancing other promising candidates, such as INO-3112, INO-5401,
VGX-3100 for anal HSIL and INO-4201. We expect that our existing cash resources will allow us to achieve important catalysts for these programs. I would like to extend
my deepest gratitude to all of our employees past and present for their efforts on behalf of the company and contributions to the important progress we re making.
Pipeline Reprioritization and Corporate Reorganization
INO-3107 Recurrent Respiratory Papillomatosis (RRP)
VGX-3100 Cervical High-Grade Squamous Intraepithelial
Other VGX-3100 Indications and Clinical Pipeline Candidates
Corporate Restructuring
Second Quarter 2023 Financial Results
INOVIO estimates that the cost savings
announced today will enable it to fund its operations into the third quarter of 2025. This projection includes a cash burn estimate of approximately $34.0 million for the third quarter of 2023 and the expectation that cash burn will decrease
incrementally throughout the remainder of 2023 and 2024. These cash projections do not include any funds that may be raised through the Company s existing
at-the-market program or other capital-raising activities.
Call / Webcast Information
INOVIO s 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 website
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
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, the need for third-party funding to continue certain development programs, expectations with respect to annual savings from corporate restructuring activities, projected cash burn for the third quarter of 2023 and reductions in spending
through 2024, and the sufficiency of our cash resources to fund operations into the third 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 June 30, 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.
CONDENSED CONSOLIDATED BALANCE SHEETS
| June 30, 2023 | December 31, 2022 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 52,712,543 | $ | 46,329,359 | ||||
| Short-term investments | 142,212,907 | 206,669,397 | ||||||
| Accounts receivable | 5,947 | 1,701,726 | ||||||
| Accounts receivable from affiliated entities | 5,110,279 | 10,036,490 | ||||||
| Prepaid expenses and other current assets | 3,230,882 | 50,130,481 | ||||||
| Prepaid expenses and other current assets from affiliated entities | 11,928 | 375,227 | ||||||
| Total current assets | 203,284,486 | 315,242,680 | ||||||
| Fixed assets, net | 6,303,949 | 7,727,997 | ||||||
| Investment in affiliated entity | 2,780,526 | 2,007,142 | ||||||
| Intangible assets, net | 2,129,861 | |||||||
| Goodwill | 10,513,371 | 10,513,371 | ||||||
| Operating lease right-of-use assets | 9,488,738 | 10,228,207 | ||||||
| Other assets | 666,890 | 684,044 | ||||||
| Total assets | $ | 233,037,960 | $ | 348,533,302 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 21,265,150 | $ | 79,686,885 | ||||
| Accounts payable and accrued expenses due to affiliated entities | 1,686,375 | 1,220,439 | ||||||
| Accrued clinical trial expenses | 6,172,382 | 10,594,073 | ||||||
| Operating lease liability | 2,351,449 | 2,803,973 | ||||||
| Grant funding liability | 3,704,781 | 2,475,031 | ||||||
| Grant funding liability from affiliated entity | 43,836 | 87,673 | ||||||
| Convertible senior notes | 16,708,329 | |||||||
| Total current liabilities | 51,932,302 | 96,868,074 | ||||||
| Convertible senior notes | 16,614,840 | |||||||
| Operating lease liability, net of current portion | 11,702,044 | 12,655,586 | ||||||
| Deferred tax liabilities | 32,046 | 32,046 | ||||||
| Total liabilities | 63,666,392 | 126,170,546 | ||||||
| Stockholders equity: | ||||||||
| Preferred stock | ||||||||
| Common stock | 268,072 | 253,090 | ||||||
| Additional paid-in capital | 1,733,826,392 | 1,710,656,191 | ||||||
| Accumulated deficit | (1,564,031,634 | ) | (1,487,847,784 | ) | ||||
| Accumulated other comprehensive loss | (691,262 | ) | (698,741 | ) | ||||
| Total Inovio Pharmaceuticals, Inc. stockholders equity | 169,371,568 | 222,362,756 | ||||||
| Total liabilities and stockholders equity | $ | 233,037,960 | $ | 348,533,302 |
INOVIO PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Revenue from collaborative arrangements and other contracts | $ | 225,971 | $ | 784,395 | $ | 340,914 | $ | 983,469 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 23,743,970 | 56,464,885 | 53,920,481 | 112,443,496 | ||||||||||||
| General and administrative | 13,523,098 | 48,456,836 | 27,413,708 | 64,410,294 | ||||||||||||
| Total operating expenses | 37,267,068 | 104,921,721 | 81,334,189 | 176,853,790 | ||||||||||||
| Loss from operations | (37,041,097 | ) | (104,137,326 | ) | (80,993,275 | ) | (175,870,321 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 2,168,233 | 857,667 | 4,375,404 | 1,527,481 | ||||||||||||
| Interest expense | (313,488 | ) | (313,488 | ) | (626,976 | ) | (626,976 | ) | ||||||||
| Gain (loss) on investment in affiliated entity | 156,745 | (934,015 | ) | 773,384 | (1,471,743 | ) | ||||||||||
| Net unrealized gain (loss) on available-for-sale equity securities | 922,941 | (3,967,101 | ) | 4,141,156 | (8,807,742 | ) | ||||||||||
| Other expense, net | (1,427,867 | ) | (3,048 | ) | (3,853,543 | ) | (156,516 | ) | ||||||||
| Net loss before share in net loss of Geneos | (35,534,533 | ) | (108,497,311 | ) | (76,183,850 | ) | (185,405,817 | ) | ||||||||
| Share in net loss of Geneos | (2,165,213 | ) | ||||||||||||||
| Net loss | $ | (35,534,533 | ) | $ | (108,497,311 | ) | $ | (76,183,850 | ) | $ | (187,571,030 | ) | ||||
| Net loss per share | ||||||||||||||||
| Basic and diluted | $ | (0.13 | ) | $ | (0.46 | ) | $ | (0.29 | ) | $ | (0.83 | ) | ||||
| Weighted average number of common shares outstanding | ||||||||||||||||
| Basic and diluted | 264,353,833 | 235,278,276 | 261,412,116 | 227,154,616 |