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INOVIO Reports Second Quarter 2024 Financial Results and Recent Business Highlights

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INOVIO (NASDAQ:INO) released its Q2 2024 financial results and recent business updates. Key developments include progress with INO-3107 for RRP, despite identifying a manufacturing issue delaying the BLA submission to mid-2025. All non-device elements of the BLA package are expected to be completed by year-end. The company plans to initiate confirmatory and redosing trials and advance regulatory efforts in Europe and the UK.

INO-3112 Phase 3 trial design submitted to European authorities, addressing HPV-16/-18 related throat cancer. INO-4201 Phase 2/3 clinical trial protocol resubmission to the FDA anticipated in Q3 2024.

Financial highlights: Cash and equivalents at $110.4M, down from $145.3M at the start of the year. R&D expenses were $23.1M, with a net loss of $32.2M this quarter. INOVIO's cash runway extends into Q3 2025 after raising $33.2M in a stock offering.

Steve Egge joined as Chief Commercial Officer to aid in commercial strategy and operations.

INOVIO (NASDAQ:INO) ha pubblicato i risultati finanziari per il secondo trimestre del 2024 e aggiornamenti recenti sulla propria attività. Tra i principali sviluppi vi è il progresso con INO-3107 per la RRP, nonostante sia emerso un problema di produzione che ritarderà la presentazione della BLA a metà del 2025. Si prevede che tutti gli elementi non dispositivi del pacchetto BLA siano completati entro la fine dell'anno. L'azienda prevede di avviare studi di conferma e ridosaggio e proseguire gli sforzi normativi in Europa e Regno Unito.

La progettazione dello studio di Fase 3 di INO-3112 è stata presentata alle autorità europee, affrontando il cancro alla gola correlato a HPV-16/-18. La riesamina del protocollo dello studio clinico di Fase 2/3 di INO-4201 è prevista per il terzo trimestre del 2024.

Risultati finanziari: Liquidità e equivalenti a 110,4 milioni di dollari, in calo rispetto ai 145,3 milioni di dollari all'inizio dell'anno. Le spese per R&D sono state di 23,1 milioni di dollari, con una perdita netta di 32,2 milioni di dollari per questo trimestre. La liquidità di INOVIO si estende fino al terzo trimestre del 2025 dopo aver raccolto 33,2 milioni di dollari in un'offerta di azioni.

Steve Egge è entrato come Chief Commercial Officer per supportare la strategia commerciale e le operazioni.

INOVIO (NASDAQ:INO) publicó sus resultados financieros del segundo trimestre de 2024 y actualizaciones recientes sobre su negocio. Los desarrollos clave incluyen progreso con INO-3107 para RRP, a pesar de identificar un problema de fabricación que retrasará la presentación de la BLA hasta mediados de 2025. Se espera que todos los elementos no relacionados con dispositivos del paquete BLA se completen a finales de año. La empresa planea iniciar ensayos de confirmación y redosificación y avanzar en los esfuerzos regulatorios en Europa y el Reino Unido.

El diseño del ensayo de Fase 3 de INO-3112 fue presentado a las autoridades europeas, abordando el cáncer de garganta relacionado con HPV-16/-18. La nueva presentación del protocolo del ensayo clínico de Fase 2/3 de INO-4201 se anticipa para el tercer trimestre de 2024.

Aspectos financieros: Cash y equivalentes en 110,4 millones de dólares, disminuyendo desde 145,3 millones de dólares al inicio del año. Gastos en I+D fueron 23,1 millones de dólares, con una pérdida neta de 32,2 millones de dólares este trimestre. La liquidez de INOVIO se extiende hasta el tercer trimestre de 2025 después de recaudar 33,2 millones de dólares en una oferta de acciones.

Steve Egge se unió como Chief Commercial Officer para ayudar en la estrategia y operaciones comerciales.

INOVIO (NASDAQ:INO)는 2024년 2분기 재무 결과와 최근 비즈니스 업데이트를 발표했습니다. 주요 개발 사항에는 RRP에 대한 INO-3107의 진행 상황이 포함되며, 제조 문제로 인해 BLA 제출이 2025년 중반으로 지연되고 있습니다. BLA 패키지의 모든 비장치 요소는 연말까지 완료될 것으로 예상됩니다. 이 회사는 확인 시험 및 재도징 시험을 시작하고 유럽 및 영국에서 규제 노력을 진행할 계획입니다.

INO-3112의 3상 시험 디자인이 HPV-16/-18 관련 인후암을 다루기 위해 유럽 당국에 제출되었습니다. INO-4201의 2/3상 임상 시험 프로토콜의 재제출은 2024년 3분기로 예상되고 있습니다.

재무 하이라이트: 현금 및 현금성 자산이 1억 1,040만 달러로, 연초의 1억 4,530만 달러에서 감소했습니다. R&D 비용은 2,310만 달러였으며, 이번 분기의 순손실은 3,220만 달러입니다. INOVIO의 현금 유효기간은 3분기 2025년까지 연장되며, 3,320만 달러의 주식 판매를 통해 자금을 조달했습니다.

Steve Egge가 상업 전략 및 운영 지원을 위해 최고 상업 책임자로 합류했습니다.

INOVIO (NASDAQ:INO) a publié ses résultats financiers du deuxième trimestre 2024 et des mises à jour récentes concernant ses activités. Parmi les développements clés, on note des progrès concernant INO-3107 pour la RRP, malgré l'identification d'un problème de fabrication qui retardera la soumission de la BLA jusqu'à mi-2025. Tous les éléments non liés aux dispositifs du paquet BLA devraient être finalisés d'ici la fin de l'année. L'entreprise prévoit de lancer des essais de confirmation et de redosage et de faire avancer ses efforts réglementaires en Europe et au Royaume-Uni.

Le design de l'essai de Phase 3 pour INO-3112 a été soumis aux autorités européennes, s'attaquant au cancer de la gorge lié à HPV-16/-18. La nouvelle soumission du protocole de l'essai clinique de Phase 2/3 pour INO-4201 est attendue au troisième trimestre 2024.

Points financiers : Trésorerie et équivalents à 110,4 millions de dollars, en baisse par rapport aux 145,3 millions de dollars au début de l'année. Dépenses R&D de 23,1 millions de dollars, avec une perte nette de 32,2 millions de dollars ce trimestre. La capacité de financement d'INOVIO s'étend jusqu'au troisième trimestre 2025 après avoir levé 33,2 millions de dollars dans une offre d'actions.

Steve Egge a rejoint en tant que Chief Commercial Officer pour aider à la stratégie commerciale et aux opérations.

INOVIO (NASDAQ:INO) hat seine Finanzzahlen für das zweite Quartal 2024 und aktuelle Geschäftsinformationen veröffentlicht. Zu den wichtigsten Entwicklungen gehört der Fortschritt bei INO-3107 für RRP, obwohl ein Herstellungsproblem die Einreichung der BLA auf Mitte 2025 verzögert. Alle nicht gerätebezogenen Elemente des BLA-Pakets werden voraussichtlich bis Ende des Jahres abgeschlossen sein. Das Unternehmen plant, Bestätigungs- und Nachdosierungsstudien zu starten und regulatorische Bemühungen in Europa und im Vereinigten Königreich voranzutreiben.

Das Studiendesign der Phase 3 von INO-3112 wurde den europäischen Behörden vorgelegt, um den mit HPV-16/-18 verbundenen Rachenkrebs zu adressieren. Die erneute Einreichung des Protokolls der Phase 2/3-Studie von INO-4201 wird für das dritte Quartal 2024 erwartet.

Finanzielle Höhepunkte: Liquidität und Äquivalente liegen bei 110,4 Millionen US-Dollar, gegenüber 145,3 Millionen US-Dollar zu Jahresbeginn. Die F&E-Ausgaben betrugen 23,1 Millionen US-Dollar, mit einem Nettoverlust von 32,2 Millionen US-Dollar in diesem Quartal. Die Liquiditätsreserve von INOVIO reicht bis ins dritte Quartal 2025, nachdem 33,2 Millionen US-Dollar durch eine Aktienemission beschafft wurden.

Steve Egge trat als Chief Commercial Officer bei, um die Handelsstrategie und -operationen zu unterstützen.

Positive
  • INO-3107 progressing towards BLA submission with all non-device elements expected to be completed by year-end.
  • INO-3107 designated an innovative medicine under the U.K.'s ILAP.
  • INO-3112 Phase 3 trial design submitted to European authorities.
  • Raised $33.2M through a stock offering, extending cash runway into Q3 2025.
  • Appointment of Steve Egge as Chief Commercial Officer, bringing extensive launch experience.
Negative
  • Manufacturing issue identified with INO-3107's device component, delaying BLA submission to mid-2025.
  • Cash and equivalents decreased to $110.4M from $145.3M as of Dec 31, 2023.
  • Net loss reported at $32.2M for the quarter.

PLYMOUTH MEETING, Pa., Aug. 8, 2024 /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 of 2024 and provided an update on recent company developments.

"We continue to make progress with our lead candidate, INO-3107, which has the potential to significantly improve the lives of patients with RRP. We expect all non-device related elements of our BLA package to be completed by year end and our pre-BLA meeting last week with the FDA provided us with confidence that we remain on the right track for the regulatory submission. However, as part of the testing process required for BLA submission, we've recently identified a manufacturing issue with the single use disposable administration component of our device that we believe is resolvable, but will take additional time to rectify," said Dr. Jacqueline Shea, INOVIO's President and Chief Executive Officer. "We're taking corrective steps to address the issue, and while we have not altered our ultimate expectations for INO-3107 to be a potentially transformative therapeutic option for RRP patients that could be the first DNA medicine approved for use in the United States, we now expect to be able to submit the BLA in mid-2025. We will continue to work hard to advance all other elements necessary for INO-3107's success, including working to initiate our confirmatory trial, advancing plans for our redosing trial, making key regulatory progress in Europe and the U.K., and continuing commercial preparations to be launch-ready if we receive approval. These efforts will help maintain the momentum that's carried us from Breakthrough Therapy Designation to BLA preparation in less than a year."

"We've continued making progress in other key areas of our business as well," Dr. Shea continued. "We submitted our Phase 3 clinical plans for INO-3112 to European regulatory authorities, anticipate re-submitting our Phase 2 clinical plans for our Ebola booster vaccine candidate, INO-4201, to the FDA in the third quarter, and are continuing discussions with partners to advance INO-5401 as a potential treatment for GBM. We also welcomed Steve Egge to our leadership team as our Chief Commercial Officer. Steve brings extensive launch experience in HPV-related diseases, cancer, immunology and rare diseases and I know his commercial expertise will be invaluable as we work to advance INO-3107 and our other promising candidates."

Recent Business Highlights

INO-3107 – Recurrent Respiratory Papillomatosis (RRP)

  • INOVIO continued advancing preparations for submitting its BLA under the FDA's Accelerated Approval pathway, including holding a pre-BLA meeting with the FDA, advancing development of all BLA modules, trial site preparations and ongoing commercial readiness plans. However, INOVIO has identified an issue related to the manufacturing of the single use disposable administration component of the CELLECTRA® device that will delay its BLA submission, now anticipated in mid-2025. INOVIO is working to rectify the issue as quickly as possible, using all resources available, and expects to provide further updates at the next quarterly report.
  • INO-3107 was designated an innovative medicine as part of the U.K.'s Innovative Licensing and Access Pathway (ILAP). The designation, called an Innovation Passport, is the first step on a development pathway that offers enhanced access to regulators and development tools that could accelerate the timeline for achieving U.K. regulatory approval.
  • INO-3107 received an Advanced Therapy Medicinal Product (ATMP) Certification from the European Medicines Agency's Committee for Advanced Therapies (CAT) after review of chemistry, manufacturing and controls (CMC) and nonclinical data. This certification confirms that the data reviewed complies with the standards that would be used to evaluate a European marketing-authorization application.
  • Immunology data for INO-3107 has been accepted at the following fourth quarter conferences:
    • Fall Voice, a leading conference for clinicians focused on vocal disorders
    • 36th International Papillomavirus Conference, a platform for sharing cutting-edge international HPV research
    • International Society for Vaccines Annual Congress

INO-3112 – Oropharyngeal Squamous Cell Carcinoma (OPSCC)

  • INOVIO submitted its Phase 3 trial design for INO-3112 to European regulatory authorities. The proposed multi-center Phase 3 trial will investigate INO-3112 in combination with LOQTORZI as a potential treatment for oropharyngeal squamous cell carcinoma (OPSCC). INOVIO plans to conduct the trial in Europe and North America. INOVIO received positive feedback on this study protocol from the FDA in the first quarter of 2024. The manufacturing issue with the single use disposable administration component of the device that is impacting INO-3107 will also need to be resolved before we can commence the Phase 3 trial with INO-3112.
  • The combination of INO-3112 with LOQTORZI has the potential to address a substantial unmet need in patients with HPV-16 and -18 related high-risk throat cancer. The Phase 3 study will investigate whether LOQTORZI can help amplify the tumor-infiltrating abilities of the antigen-specific T cells generated by INO-3112. INO-3112 is a DNA medicine candidate containing a DNA plasmid encoding HPV-16/-18 E6 and E7 antigens combined with another DNA plasmid encoding IL-12 as an immune activator. LOQTORZI is an FDA-approved PD-1 inhibitor approved for the treatment of recurrent locally advanced/metastatic nasopharyngeal carcinoma.

INO-4201 for Ebola

  • INOVIO anticipates submitting its revised protocol to the FDA for a Phase 2/3 clinical trial with INO-4201 as a heterologous boost to the FDA licensed Ebola vaccine, Ervebo, in the third quarter. INOVIO previously announced positive results from a Phase 1b clinical trial evaluating INO-4201 as a booster in healthy adult participants who previously received a single injection of Ervebo. In the trial, INO-4201 was well-tolerated and boosted humoral responses in 100% (36 of 36) of treated participants.

Operational and Financial Updates

  • INOVIO appointed Steve Egge as Chief Commercial Officer to lead the company's commercial strategy and operations as it prepares to launch INO-3107. Mr. Egge has extensive experience in many different therapeutic areas, including immunology and vaccines, HPV, and rare disease. Mr. Egge spent 20 years at Merck, where he held a number of different commercial leadership roles, including leading Merck's HPV Vaccines Franchise and serving as Chief Marketing Officer for the Vaccine Division. Over the course of his career, he has overseen or contributed to more than 13 commercial product launches. INOVIO welcomes his expertise, particularly in creating and growing new therapeutic areas as well as driving market share in competitive markets.
  • INOVIO strengthened its balance sheet with an offering of common stock and pre-funded warrants in April 2024; net proceeds from the offering, after deducting underwriting discounts and commissions and offering expenses, were $33.2 million.

Second Quarter 2024 Financial Results

  • Cash, Cash Equivalents and Short-term Investments: As of June 30, 2024, cash, cash equivalents and short-term investments were $110.4 million compared to $145.3 million as of December 31, 2023.
  • Research and Development (R&D) Expenses: R&D expenses for the three months ended June 30, 2024, were $23.1 million compared to $23.7 million for the same period in 2023. The slight decrease in R&D expenses was primarily the result of overall lower drug manufacturing costs and lower employee and consultant compensation, including non-cash stock-based compensation, among other variances.
  • General and Administrative (G&A) Expenses: G&A expenses were $10.2 million for the three months ended June 30, 2024 compared to $13.5 million for the same period in 2023. The decrease in G&A expenses was primarily related to a decrease in employee compensation, including non-cash employee and consultant stock-based compensation, and a decrease in legal expenses, among other variances.
  • Total Operating Expenses: Total operating expenses were $33.3 million for the three months ended June 30, 2024, compared to $37.3 million for the same period in 2023.
  • Net Loss: INOVIO's net loss for the three months ended June 30, 2024 was $32.2 million, or $1.19 per basic and diluted share, compared to net loss of $35.5 million, or $1.61 per basic and diluted share, for the three months ended June 30, 2023.
  • Shares Outstanding: As of June 30, 2024, INOVIO had 26.0 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 June 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 $28 million for the third quarter of 2024. These cash runway projections do not include any further capital-raising activities that INOVIO may undertake.

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 towards the middle of 2025, 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 third 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 June 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



June 30,
 2024


December 31,
 2023


(Unaudited)



ASSETS




Current assets:




Cash and cash equivalents

$34,392,404


$14,310,862

Short-term investments

76,029,116


130,982,913

Accounts receivable from affiliated entities

1,773,665


2,405,228

Prepaid expenses and other current assets

5,365,860


5,393,665

Prepaid expenses and other current assets from affiliated entities


20,432

Total current assets

117,561,045


153,113,100

Fixed assets, net

4,510,869


4,960,986

Investment in affiliated entity

2,319,975


2,780,287

Operating lease right-of-use assets

8,819,399


9,491,735

Other assets

585,915


605,315

Total assets

$133,797,203


$170,951,423

LIABILITIES AND STOCKHOLDERS' EQUITY




Current liabilities:




Accounts payable and accrued expenses

$16,634,761


$19,847,744

Accounts payable and accrued expenses due to affiliated entity

1,921,457


1,070,519

Accrued clinical trial expenses

5,499,648


2,365,382

Operating lease liability

2,321,984


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

26,399,768


42,570,228

Operating lease liability, net of current portion

10,658,228


11,032,066

Total liabilities

37,057,996


53,602,294

Stockholders' equity:




Preferred stock


Common stock

25,962


22,792

Additional paid-in capital

1,783,074,886


1,740,954,074

Accumulated deficit

(1,685,672,105)


(1,622,965,136)

Accumulated other comprehensive loss

(689,536)


(662,601)

Total Inovio Pharmaceuticals, Inc. stockholders' equity

96,739,207


117,349,129

Total liabilities and stockholders' equity

$133,797,203


$170,951,423

 

Inovio Pharmaceuticals, Inc.

CONSOLIDATED STATEMENTS OF OPERATIONS



Three Months Ended June 30,


Six Months Ended June 30,


2024


2023


2024


2023









Revenue from collaborative arrangements and other contracts

$100,762


$225,971


$100,762


$340,914

Operating expenses:








Research and development

23,090,989


23,743,970


44,001,307


53,920,481

General and administrative

10,206,686


13,523,098


20,781,337


27,413,708

Total operating expenses

33,297,675


37,267,068


64,782,644


81,334,189

Loss from operations

(33,196,913)


(37,041,097)


(64,681,882)


(80,993,275)

Other income (expense):








Interest income

1,307,358


2,168,233


2,807,648


4,375,404

Interest expense


(313,488)


(177,833)


(626,976)

(Loss) gain on investment in affiliated entity

(334,294)


156,745


(460,312)


773,384

Net unrealized (loss) gain on available-for-sale equity securities

(20,820)


922,941


480,057


4,141,156

Other income (expense), net

7,571


(1,427,867)


(674,647)


(3,853,543)

Net loss

$(32,237,098)


$(35,534,533)


$(62,706,969)


$(76,183,850)

Net loss per share








          Basic and diluted (1)

$(1.19)


$(1.61)


$(2.48)


$(3.50)

Weighted average number of common shares used to
compute net loss per share








          Basic and diluted (1)

27,197,802


22,029,486


25,244,657


21,784,343


(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.

 

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/inovio-reports-second-quarter-2024-financial-results-and-recent-business-highlights-302218314.html

SOURCE INOVIO Pharmaceuticals, Inc.

FAQ

What was INO's cash position as of June 30, 2024?

As of June 30, 2024, INOVIO had $110.4 million in cash, cash equivalents, and short-term investments.

Why is the BLA submission for INO-3107 delayed?

A manufacturing issue with the single-use disposable administration component of the CELLECTRA device caused the delay, pushing the BLA submission to mid-2025.

What were INOVIO's R&D expenses in Q2 2024?

INOVIO's R&D expenses for Q2 2024 were $23.1 million.

What is the expected cash runway for INOVIO post stock offering?

INOVIO estimates its cash runway to extend into Q3 2025.

What are the developments concerning INO-3112?

INOVIO submitted its Phase 3 trial design for INO-3112 to European regulatory authorities to investigate its use in HPV-16/-18 related throat cancer.

Inovio Pharmaceuticals, Inc.

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