INOVIO Reports Third Quarter 2024 Financial Results and Recent Business Highlights
INOVIO reported Q3 2024 financial results and updates on INO-3107 development for RRP treatment. New immunology data showed INO-3107's ability to induce T cell responses against HPV-6 and HPV-11. The Phase 1/2 trial demonstrated 81% clinical response rate, with 28% of patients requiring no surgical intervention. Financial highlights include cash position of $84.8M, R&D expenses of $18.7M, and net loss of $25.2M. The company targets BLA submission for mid-2025, with all non-device modules expected to be completed by end of 2024. Cash runway is projected into Q3 2025.
INOVIO ha riportato i risultati finanziari del terzo trimestre del 2024 e aggiornamenti sullo sviluppo di INO-3107 per il trattamento della RRP. I nuovi dati immunologici hanno dimostrato la capacità di INO-3107 di indurre risposte delle cellule T contro HPV-6 e HPV-11. La fase 1/2 della sperimentazione clinica ha mostrato un tasso di risposta clinica dell'81%, con il 28% dei pazienti che non ha necessitato di intervento chirurgico. Principali punti finanziari includono una posizione di liquidità di 84,8 milioni di dollari, spese per ricerca e sviluppo di 18,7 milioni di dollari e una perdita netta di 25,2 milioni di dollari. L'azienda punta a presentare la richiesta BLA entro metà 2025, con tutti i moduli non dispositivi previsti per essere completati entro la fine del 2024. Si prevede che la liquidità si estenda fino al terzo trimestre del 2025.
INOVIO reportó los resultados financieros del tercer trimestre de 2024 y actualizaciones sobre el desarrollo de INO-3107 para el tratamiento de la RRP. Los nuevos datos de inmunología mostraron la capacidad de INO-3107 para inducir respuestas de células T contra HPV-6 y HPV-11. El ensayo de Fase 1/2 demostró una tasa de respuesta clínica del 81%, con un 28% de los pacientes que no requerían intervención quirúrgica. Aspectos financieros destacados incluyen una posición de efectivo de 84,8 millones de dólares, gastos de I+D de 18,7 millones de dólares y una pérdida neta de 25,2 millones de dólares. La compañía tiene como objetivo la presentación de la BLA para mediados de 2025, con todos los módulos no relacionados con dispositivos se espera que se completen a finales de 2024. La proyección de efectivo se extiende hasta el tercer trimestre de 2025.
INOVIO는 2024년 3분기 재무 결과와 RRP 치료를 위한 INO-3107 개발 업데이트를 보고했습니다. 새로운 면역학 데이터는 INO-3107이 HPV-6 및 HPV-11에 대한 T 세포 반응을 유도할 수 있는 능력을 보여주었습니다. 1/2상 시험에서 81%의 임상 반응률이 나타났으며, 28%의 환자가 수술 개입 없이 치료를 받을 수 있었습니다. 재무 하이라이트로는 현금 보유액이 8,480만 달러, 연구 및 개발 비용이 1,870만 달러, 순손실이 2,520만 달러가 포함됩니다. 회사는 2025년 중반에 BLA 제출을 목표로 하고 있으며, 비장치 모듈은 2024년 말까지 완료될 것으로 예상하고 있습니다. 현금 소진은 2025년 3분기까지 이어질 것으로 보입니다.
INOVIO a rapporté les résultats financiers du troisième trimestre 2024 et des mises à jour sur le développement de l'INO-3107 pour le traitement de la RRP. De nouvelles données en immunologie ont montré la capacité de l'INO-3107 à induire des réponses des cellules T contre HPV-6 et HPV-11. L'essai de phase 1/2 a démontré un taux de réponse clinique de 81 %, avec 28 % des patients ne nécessitant aucune intervention chirurgicale. Faits saillants financiers incluent une position de liquidités de 84,8 millions de dollars, des dépenses en R&D de 18,7 millions de dollars et une perte nette de 25,2 millions de dollars. L'entreprise vise une soumission de BLA pour le milieu de 2025, avec tous les modules non liés aux dispositifs devant être achevés d'ici fin 2024. La trésorerie est prévue jusqu'au troisième trimestre de 2025.
INOVIO berichtete über die Finanz Ergebnisse des 3. Quartals 2024 und Updates zur Entwicklung von INO-3107 zur Behandlung von RRP. Neue immunologische Daten zeigten die Fähigkeit von INO-3107, T-Zell-Antworten gegen HPV-6 und HPV-11 zu induzieren. Die Phase 1/2 Studie zeigte eine klinische Ansprechrate von 81 %, wobei 28 % der Patienten keinen chirurgischen Eingriff benötigten. Finanzielle Höhepunkte umfassen eine Liquiditätsposition von 84,8 Millionen Dollar, F & E-Ausgaben von 18,7 Millionen Dollar und einen Nettoverlust von 25,2 Millionen Dollar. Das Unternehmen plant eine Einreichung des BLA bis Mitte 2025, wobei erwartet wird, dass alle nicht gerätebezogenen Module bis Ende 2024 abgeschlossen sind. Die Cash-Bedarf wird bis ins 3. Quartal 2025 prognostiziert.
- 81% clinical response rate in Phase 1/2 trial for INO-3107
- 28% of patients achieved complete response requiring no surgical intervention
- Strong safety profile with no treatment-related AEs above Grade 2
- Net loss of $25.2M in Q3 2024
- Cash position decreased to $84.8M from $145.3M in December 2023
- R&D expenses increased to $18.7M from $15.5M year-over-year
Insights
The Q3 2024 results reveal concerning financial metrics for INOVIO. The company reported a
While R&D expenses increased to
The diluted share count of 29.9 million and ongoing cash burn rate indicate likely need for additional capital raising, which could lead to further dilution for existing shareholders.
The immunology data for INO-3107 shows promising therapeutic potential. Key findings include sustained T cell responses against HPV-6 and HPV-11 through week 52, indicating durable immunity. The expansion of new clonal T cell populations and their infiltration into target tissues, coupled with an
The safety profile is particularly encouraging, with no treatment-related adverse events above Grade 2 and only minor side effects like injection site pain. The
- New immunology data for INO-3107 supporting proposed mechanism of action presented at several recent conferences
- Data showed ability of INO-3107 to induce an antigen-specific cytotoxic T cell response against HPV-6 and HPV-11 and drive recruitment of T cells into airway tissues and papilloma
- Data showed INO-3107 induced expansion of new clonal T cells that infiltrate airway tissues and correspond with reduction of surgeries for RRP patients observed in Phase 1/2 trial
- Continued progress on preparing regulatory submissions for INO-3107
- All non-device BLA modules on track for completion by end of 2024
- BLA submission remains targeted for mid-2025
"We continue to be focused on advancing INO-3107 and delivering a non-surgical option to RRP patients. Toward this goal, we expect to have all non-device modules for our BLA completed by year end, while in parallel we continue to implement the plan to resolve the previously announced manufacturing issue with the single-use array component of the device. With this progress, we continue to target the submission of our BLA in mid-2025," said Dr. Jacqueline Shea, INOVIO's President and Chief Executive Officer. "Our development of INO-3107 is supported by a growing body of research that collectively points to INO-3107's potential to be an important therapeutic option for all RRP patients regardless of the severity of their disease. We recently presented new immunology data highlighting the ability of INO-3107 to induce new populations of T cells that travel to the airway tissue and papilloma and correspond with clinical benefit. We've also presented our full safety and efficacy data, demonstrating that INO-3107 was shown to be well tolerated and have clinical benefit in the Phase 1/2 trial. Additionally, by the end of year, we anticipate announcing long-term clinical durability data. We continue to believe INO-3107 has the potential to become the preferred choice for the broadest number of RRP patients, healthcare providers and payors, if approved."
Recent Business Highlights
Lead Candidate, INO-3107 – Recurrent Respiratory Papillomatosis
INOVIO's primary focus is driving toward the regulatory approval and commercialization of its lead product candidate, INO-3107. Recent progress includes advancing preparations for submitting the BLA, targeted for mid-2025, and announcing the following new data.
New Immunology Data: INOVIO presented additional immunology data demonstrating the ability of INO-3107 to induce antigen-specific T cell responses against HPV-6 and HPV-11 and drive recruitment of those T cells into airway tissues and papilloma of RRP patients, which could potentially slow or eliminate papilloma regrowth. These data were presented at the American Association for Cancer Research (AACR) Special Conference and at the 36th International Papillomavirus Conference. In totality, this new data showed:
- Induction of T cell responses specific to HPV-6 and HPV-11, including cytotoxic CD8+ T cells, which were still present at week 52, indicating an establishment of memory response
- Expansion of clonal T cell populations in peripheral blood, including induction of new clonal T cell populations that travelled to airway or papilloma tissue
- Induction of inflammatory responses in papilloma and airway tissue, including:
- Interferon, cytokine and chemokine signaling
- Adaptive and innate immune cell infiltration, with emphasis on T cells - Cytotoxic signatures of infiltrated T cells in papilloma/airway tissue, providing direct evidence of increased overall T cell infiltration compared to pre-treatment
- T cell infiltration in airway tissues of clinical responders were predominantly new T cell clonal populations not detectable prior to INO-3107 treatment
- Clinical activity not impacted by immunosuppressive papilloma microenvironment
Full Safety and Efficacy Data: INOVIO presented its full safety and efficacy data set for the Phase 1/2 trial in which INO-3107 was shown to be well tolerated and have clinical benefit. Of the 32 patients in the trial, 26 patients, or
In the trial, the overall clinical response (OCR) was
- INO-3107 was shown to be well tolerated and have clinical benefit
-41% (13/32) of patients reported a treatment-related Adverse Event (AE)
- No treatment-related AEs greater than Grade 2 severity were reported
- Most frequent treatment-related AE's reported were injection site pain (31% ) and fatigue (9% ) - Modified Derkay-Pransky severity scores improved from baseline to the end of 52-week trial
- INO-3107 induced durable cellular responses and generated T cells against HPV-6 and HPV-11
Other Pipeline Updates
- INOVIO continued to advance plans for a Phase 3 trial of INO-3112 as a potential treatment for HPV-related oropharyngeal squamous cell carcinoma also known as throat cancer, through ongoing conversations with regulators in the European Union. This trial is anticipated to be conducted in
North America andEurope . Previously, the FDA had indicated alignment with the proposed trial design, which was developed in conjunction with a trial steering committee. - INOVIO continued to advance its plans for a Phase 2 trial of INO-4201 as a heterologous boost to the FDA licensed Ebola vaccine, Ervebo®. A meeting is scheduled with the FDA in the fourth quarter of 2024 to discuss the proposed Phase 2 trial design.
- Patients continue to be dosed in the GBM-001 trial with INO-5401. Regeneron and Inovio have discussed that an appropriate next step would be a controlled Phase 2 trial.
Third Quarter 2024 Financial Results
- Cash, Cash Equivalents and Short-term Investments: As of September 30, 2024, cash, cash equivalents and short-term investments were
$84.8 million $145.3 million - Research and Development (R&D) Expenses: R&D expenses for the three months ended September 30, 2024, were
$18.7 million $15.5 million - General and Administrative (G&A) Expenses: G&A expenses were
$8.6 million $9.9 million - Total Operating Expenses: Total operating expenses were
$27.3 million $35.9 million $10.5 million - Net Loss: Net loss for the three months ended September 30, 2024 was
$25.2 million $0.89 $33.9 million $1.52 - Shares Outstanding: As of September 30, 2024, INOVIO had 26.1 million common shares outstanding, 2.1 million pre-funded warrants outstanding, and 29.9 million common shares outstanding on a fully diluted basis, after giving effect to the exercise, vesting, and conversion, as applicable, of its outstanding pre-funded warrants, options, restricted stock units and convertible preferred stock.
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 September 30, 2024, which can be accessed at: http://ir.inovio.com/financials/default.aspx.
Cash Guidance
INOVIO estimates its cash runway to extend into the third quarter of 2025. This projection includes an operational net cash burn estimate of approximately
Conference Call / Webcast Information
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 http://ir.inovio.com/events-and-presentations/default.aspx.
About INOVIO's DNA Medicines Platform
INOVIO's 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.
About INOVIO
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.
Contact:
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 mid-2025, expectations regarding INO-3107's potential to be an important therapeutic option for RRP patients and the preferred choice of RRP patients, healthcare providers and payors, as well as 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 into the third quarter of 2025 and expected cash burn for the fourth 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 September 30, 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 | |||
September 30, | December 31, | ||
(Unaudited) | |||
ASSETS | |||
Current assets: | |||
Cash and cash equivalents | |||
Short-term investments | 63,117,288 | 130,982,913 | |
Accounts receivable from affiliated entities | 1,862,739 | 2,405,228 | |
Prepaid expenses and other current assets | 4,617,116 | 5,393,665 | |
Prepaid expenses and other current assets from affiliated entity | — | 20,432 | |
Total current assets | 91,284,623 | 153,113,100 | |
Fixed assets, net | 4,091,562 | 4,960,986 | |
Investment in affiliated entity | 2,644,226 | 2,780,287 | |
Operating lease right-of-use assets | 8,472,848 | 9,491,735 | |
Other assets | 566,415 | 605,315 | |
Total assets | |||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||
Current liabilities: | |||
Accounts payable and accrued expenses | |||
Accounts payable and accrued expenses due to affiliated entity | 1,834,266 | 1,070,519 | |
Accrued clinical trial expenses | 4,496,568 | 2,365,382 | |
Operating lease liability | 2,425,112 | 2,406,522 | |
Grant funding liability | — | 87,489 | |
Grant funding liability from affiliated entity | — | 21,918 | |
Convertible senior notes | — | 16,770,654 | |
Total current liabilities | 23,499,137 | 42,570,228 | |
Operating lease liability, net of current portion | 10,020,227 | 11,032,066 | |
Total liabilities | 33,519,364 | 53,602,294 | |
Stockholders' equity: | |||
Preferred stock | — | — | |
Common stock | 26,051 | 22,792 | |
Additional paid-in capital | 1,784,975,303 | 1,740,954,074 | |
Accumulated deficit | (1,710,837,583) | (1,622,965,136) | |
Accumulated other comprehensive loss | (623,461) | (662,601) | |
Total Inovio Pharmaceuticals, Inc. stockholders' equity | 73,540,310 | 117,349,129 | |
Total liabilities and stockholders' equity | |||
Inovio Pharmaceuticals, Inc. CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||
2024 | 2023 | 2024 | 2023 | ||||
Revenue from collaborative arrangements and other contracts | $— | ||||||
Operating expenses: | |||||||
Research and development | 18,733,584 | 15,503,032 | 62,734,891 | 69,423,513 | |||
General and administrative | 8,613,895 | 9,925,055 | 29,395,232 | 37,338,763 | |||
Impairment of goodwill | — | 10,513,371 | — | 10,513,371 | |||
Total operating expenses | 27,347,479 | 35,941,458 | 92,130,123 | 117,275,647 | |||
Loss from operations | (27,347,479) | (35,553,012) | (92,029,361) | (116,546,288) | |||
Other income (expense): | |||||||
Interest income | 1,106,758 | 1,938,745 | 3,914,406 | 6,314,149 | |||
Interest expense | — | (313,488) | (177,833) | (940,464) | |||
Gain (loss) on investment in affiliated entity | 324,251 | 214,374 | (136,061) | 987,758 | |||
Net unrealized gain (loss) on available-for-sale equity securities | 1,330,811 | (219,337) | 1,810,868 | 3,921,819 | |||
Other (expense) income, net | (579,819) | 2,854 | (1,254,466) | (3,850,688) | |||
Net loss | |||||||
Net loss per share | |||||||
Basic and diluted (1) | |||||||
Weighted average number of common shares used to compute net loss per share | |||||||
Basic and diluted (1) | 28,140,497 | 22,385,229 | 26,216,983 | 21,986,840 | |||
(1) Share and per share amounts have been restated to reflect the 1-for-12 reverse stock split effected in January 2024 on a retroactive basis for all periods presented. |
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SOURCE INOVIO Pharmaceuticals, Inc.
FAQ
What were INOVIO's (INO) Q3 2024 financial results?
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When does INOVIO plan to submit the BLA for INO-3107?
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