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Inovio Pharmaceuticals(INO) - 2024 Q3 - Earnings Call Transcript
2024-11-15 00:53
Financial Data and Key Metrics - Total operating expenses for Q3 2024 decreased by 24% to $27.3 million compared to $35.9 million in Q3 2023 [24] - Net loss for Q3 2024 was $25.2 million, or $0.89 per share, compared to a net loss of $33.9 million, or $1.52 per share, in Q3 2023 [24] - Cash, cash equivalents, and short-term investments stood at $84.8 million as of September 30, 2024, down from $145.3 million at the end of 2023 [25] - Estimated cash runway extends into Q3 2025, with an operational net cash burn of approximately $24 million projected for Q4 2024 [25] Business Line Data and Key Metrics - INO-3107, the lead product candidate, showed an 81% overall clinical response rate in the Phase 1/2 trial, with 28% of patients requiring no surgical intervention and 44% experiencing a reduction of at least 50% in surgeries [15] - INO-3112 is being evaluated in a proposed Phase 3 trial in combination with LOQTORZI for HPV16/18 positive oropharyngeal squamous cell carcinoma, with discussions ongoing with European regulators [8] - INO-5401 continues to be dosed in the GBM-001 trial for glioblastoma, with plans for a controlled Phase 2 trial [9] - INO-4201 is being developed as a heterologous boost to the Ebola vaccine Ervebo, with an upcoming FDA meeting to discuss Phase 2 trial design [10] Market Data and Key Metrics - The company is preparing for the potential commercialization of INO-3107, targeting a BLA submission by mid-2025 and aiming to be launch-ready by the end of 2025 [7][22] - Market research indicates strong potential for INO-3107, with feedback from payers confirming acceptability of pricing in line with rare disease standards [21] - The company is planning a lean and efficient commercial footprint, including field teams, to support the launch of INO-3107 [22] Company Strategy and Industry Competition - The company is focused on advancing INO-3107 towards commercialization while continuing to develop its broader pipeline, including INO-3112, INO-5401, and INO-4201 [5][8][9][10] - The company believes INO-3107 has a compelling product profile and could become the preferred treatment for RRP patients, supported by new immunology data [6][19] - The company is addressing a manufacturing issue related to the single-use component of its device, with progress being made towards resolution [7][35] Management Commentary on Operating Environment and Future Outlook - Management remains confident in the potential of INO-3107 to transform the treatment paradigm for RRP patients, supported by strong clinical and immunology data [6][19] - The company is focused on financial discipline, reducing operating expenses while advancing key programs [11] - Management anticipates announcing long-term durability data from the Phase 1/2 trial of INO-3107 by year-end [20] Other Important Information - The company has presented new immunology data at scientific conferences, highlighting the mechanism of action of INO-3107 and its potential to reduce or eliminate the need for surgeries in RRP patients [6][16][17] - The company is preparing for a confirmatory trial for INO-3107, which will be a placebo-controlled study with a two-to-one randomization and a longer follow-up period [43][50] Q&A Session Summary Question: Regulatory updates for INO-3107 outside the US - The company has met with UK and European regulators, who have advised that placebo-controlled data will be required for approval in those markets [28] - Discussions with Japan and China are ongoing, with interest in expanding into those regions [28] Question: Physician feedback on new immunology data - Physicians and key opinion leaders have been impressed with the immunology data, which supports the clinical efficacy of INO-3107 [29][31] Question: Steps to resolve manufacturing issues - The company is working closely with the manufacturer to address the issue with the single-use component of the device and is making good progress [35] Question: Competitive landscape for INO-3107 - The company believes INO-3107 has a differentiated product profile compared to competitors, with a focus on reducing the need for surgeries and a well-tolerated treatment regimen [38][39] Question: Confirmatory trial design for INO-3107 - The confirmatory trial will be a placebo-controlled study with a two-to-one randomization and a longer follow-up period to better characterize the clinical benefit of INO-3107 [43][50] Question: Redosing strategy for INO-3107 - The company plans to conduct redosing studies in commercial patients post-launch to evaluate the potential for maintaining long-term responses [62] Question: Commercial strategy for INO-3107 - The company plans to have MSLs and national account managers engage with health plans ahead of approval, with a focus on differentiating INO-3107 based on its clinical data [59]
INOVIO Reports Third Quarter 2024 Financial Results and Recent Business Highlights
Prnewswire· 2024-11-14 21:05
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 reg ...
Immunology Data Shows INOVIO's INO-3107 Induced Expansion of New Clonal T Cells That Infiltrate Airway Tissue and Correspond With Reduction of Surgeries for RRP Patients Observed in Phase 1/2 Trial
Prnewswire· 2024-11-13 13:00
New immunology data shows INO-3107 induced an expansion of new clonal T cells in blood that were not detectable prior to treatment New clonal T cells in the blood travelled to papilloma and airway tissues and generated an inflammatory and anti-viral response consistent with a reduced need for surgeries for patients with recurrent respiratory papillomatosis (RRP) caused by HPV-6 and HPV-11 Data supporting mechanism of action for INO-3107 to be presented at 36th International Papillomavirus Conference in Ed ...
INOVIO to Report Third Quarter 2024 Financial Results on November 14, 2024
Prnewswire· 2024-11-06 13:00
PLYMOUTH MEETING, Pa., Nov. 6, 2024 /PRNewswire/ -- INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-associated diseases, cancer, and infectious diseases, today announced that third quarter 2024 financial results will be released after the market close on November 14, 2024. Following the release, INOVIO will host a live conference call and webcast at 4:30 p.m. ET to discuss financial results and provide a general ...
INOVIO Announces New Data at Scientific Conferences for Lead Candidate, INO-3107, as a Potential Treatment for RRP
Prnewswire· 2024-10-21 12:00
American Association for Cancer Research (AACR) Special Conference: Tumor Immunology and Immunotherapy: New immunology data showed ability of INO-3107 to induce an antigen-specific T cell response against HPV-6 and HPV-11 and drive recruitment of T cells into airway tissues and papillomaInternational Society of Vaccines Conference: Full safety and efficacy data from Phase 1/2 clinical study in patients with Recurrent Respiratory Papillomatosis (RRP) indicated that INO-3107 was well tolerated and immunogenic ...
INOVIO to Present at Upcoming Scientific Conferences
Prnewswire· 2024-10-01 12:00
PLYMOUTH MEETING, Pa., Oct. 1, 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 that it will present at the following scientific conferences: AACR Special Conference in Cancer Research: Tumor Immunology and Immunotherapy Poster by Dr. Matthew Morrow, VP of Translational Sciences at INOVIO Abstract Title: Reduction in Surgical In ...
INOVIO to Present at Upcoming Scientific Conference
Prnewswire· 2024-09-17 20:30
PLYMOUTH MEETING, Pa., Sept. 17, 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 that it will present at the following scientific conference: World Congress of Electroporation Oral Presentation by Trevor Smith, VP of Preclinical R&D at INOVIO Abstract Title: Development of in vivo-launched synthetic DNA-encoded antibodies emplo ...
Inovio Pharmaceuticals(INO) - 2024 Q2 - Earnings Call Transcript
2024-08-09 07:32
Inovio Pharmaceuticals, Inc. (NASDAQ:INO) Q2 2024 Earnings Conference Call August 8, 2024 4:30 PM ET Company Participants Thomas Hong - Manager of Investor Relations Jacqueline Shea - President & Chief Executive Officer Steve Egge - Chief Commercial Officer Michael Sumner - Chief Medical Officer Peter Kies - Chief Financial Officer Conference Call Participants Anish Nikhanj - RBC Capital Markets Roy Buchanan - Citizens JMP Jay Olson - Oppenheimer Sudan Loganathan - Stephens Yi Chen - H.C. Wainwright Operato ...
Inovio Pharmaceuticals(INO) - 2024 Q2 - Quarterly Results
2024-08-08 21:00
Clinical Trials and Regulatory Updates - INO-3107 BLA submission delayed to mid-2025 due to manufacturing issues with the single-use disposable administration component of the CELLECTRA® device[2][3] - INO-3107 designated as an innovative medicine under the U.K.'s Innovative Licensing and Access Pathway (ILAP) and received Advanced Therapy Medicinal Product (ATMP) Certification from the European Medicines Agency[3] - INO-3112 Phase 3 trial design submitted to European regulatory authorities, with plans to investigate INO-3112 in combination with LOQTORZI for oropharyngeal squamous cell carcinoma (OPSCC)[4] - INO-4201 Phase 2/3 clinical trial protocol for Ebola booster expected to be submitted to the FDA in Q3 2024[5] Financial Performance and Cash Position - Cash, cash equivalents, and short-term investments totaled $110.4 million as of June 30, 2024, compared to $145.3 million as of December 31, 2023[7] - R&D expenses for Q2 2024 were $23.1 million, a slight decrease from $23.7 million in Q2 2023[7] - G&A expenses for Q2 2024 were $10.2 million, down from $13.5 million in Q2 2023[7] - Net loss for Q2 2024 was $32.2 million, or $1.19 per share, compared to a net loss of $35.5 million, or $1.61 per share, in Q2 2023[7] - INOVIO estimates its cash runway to extend into Q3 2025, with an operational net cash burn estimate of approximately $28 million for Q3 2024[9] - Cash and cash equivalents increased to $34,392,404 as of June 30, 2024, compared to $14,310,862 as of December 31, 2023[14] - Short-term investments decreased to $76,029,116 as of June 30, 2024, from $130,982,913 as of December 31, 2023[14] - Total current assets decreased to $117,561,045 as of June 30, 2024, from $153,113,100 as of December 31, 2023[14] - Total liabilities decreased to $37,057,996 as of June 30, 2024, from $53,602,294 as of December 31, 2023[14] - Revenue from collaborative arrangements and other contracts for the six months ended June 30, 2024, was $100,762, compared to $340,914 for the same period in 2023[15] - Research and development expenses for the six months ended June 30, 2024, were $44,001,307, compared to $53,920,481 for the same period in 2023[15] - General and administrative expenses for the six months ended June 30, 2024, were $20,781,337, compared to $27,413,708 for the same period in 2023[15] - Net loss for the six months ended June 30, 2024, was $(62,706,969), compared to $(76,183,850) for the same period in 2023[15] - Basic and diluted net loss per share for the six months ended June 30, 2024, was $(2.48), compared to $(3.50) for the same period in 2023[15] - Weighted average number of common shares used to compute net loss per share for the six months ended June 30, 2024, was 25,244,657, compared to 21,784,343 for the same period in 2023[15] Leadership and Organizational Updates - Steve Egge appointed as Chief Commercial Officer to lead commercial strategy and operations, bringing extensive experience in HPV, immunology, and rare diseases[6]
INOVIO Reports Second Quarter 2024 Financial Results and Recent Business Highlights
Prnewswire· 2024-08-08 20:05
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 R ...