Inovio Pharmaceuticals(INO)
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INOVIO Highlights Anticipated 2025 Milestones and 2024 Key Accomplishments
Prnewswire· 2025-01-09 13:04
PLYMOUTH MEETING, Pa., Jan. 9, 2025 /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 highlighted anticipated milestones for 2025 and key accomplishments from 2024 in advance of upcoming investor meetings."Based on the progress achieved in 2024, we anticipate 2025 to be a transformational year for INOVIO as we move closer to our goal of becomi ...
Gold Down Over 1%; Inovio Pharmaceuticals Shares Plummet
Benzinga· 2024-12-13 19:10
U.S. stocks traded mixed toward the end of trading, with the S&P 500 edging lower on Friday.The Dow traded down 0.14% to 43,851.19 while the NASDAQ rose 0.04% to 19,911.75. The S&P 500 also fell, dropping, 0.04% to 6,048.90.Check This Out: Jim Cramer Says This CEO ‘Built An Amazing Company,’ Recommends Buying NetflixLeading and Lagging SectorsInformation technology shares jumped by 0.3% on Friday.In trading on Friday, materials shares fell by 1.1%.Top HeadlineU.S. import prices increased by 0.1% from the pr ...
INOVIO Announces Pricing of $30 Million Public Offering
Prnewswire· 2024-12-13 12:00
PLYMOUTH MEETING, Pa., Dec. 13, 2024 /PRNewswire/ -- INOVIO Pharmaceuticals, Inc. (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 the pricing of an underwritten public offering of 10,000,000 shares of its common stock and accompanying warrants to purchase 10,000,000 shares of its common stock at an exercise price of $3.76 per share of common stock, at a ...
INOVIO Announces Proposed Public Offering
Prnewswire· 2024-12-12 21:01
PLYMOUTH MEETING, Pa., Dec. 12, 2024 /PRNewswire/ -- INOVIO Pharmaceuticals, Inc. (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 intends to offer and sell shares of its common stock and accompanying warrants to purchase shares of its common stock, in an underwritten public offering. All of the securities in the proposed offering will be sold by ...
New Retrospective Data Shows Half of RRP Patients Treated with INO-3107 Achieved a Complete Response When Evaluated 2 and 3 Years Following Initial Phase 1/2 Trial
Prnewswire· 2024-12-03 13:00
Data from a retrospective trial evaluating the longer-term benefit of INO-3107 to patients with Recurrent Respiratory Papillomatosis (RRP) involved in a Phase 1/2 trial showed the number of patients who met the criteria for a Complete Response (CR) increased to 50% by the end of year 2 and to 54% in year 3, compared to 28% by the end of the initial 52-week trial 95% of patients in the retrospective trial (RRP-002) maintained or enhanced their original Overall Response Rate (ORR) reported in the Phase 1/2 t ...
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 Pharmaceuticals(INO) - 2024 Q3 - Earnings Call Presentation
2024-11-14 22:30
Third Quarter 2024 Financial Results November 14, 2024 1 :INO 2 Agenda • Introduction ◦ Thomas Hong, Manager, IR • CEO Perspective & Corporate Progress ◦ Jacqueline Shea, PhD, President & Chief Executive Officer • INO-3107 Update ◦ Michael Sumner, MBBS, MBA, Chief Medical Officer ◦ Steve Egge, Chief Commercial Officer • Financial Results ◦ Peter Kies, Chief Financial Officer This presentation includes statements that are, or may be deemed, "forward-looking statements,"" within the meaning of Section 27A of ...
Inovio Pharmaceuticals(INO) - 2024 Q3 - Quarterly Results
2024-11-14 21:07
Exhibit 99.1 INOVIO Reports Third Quarter 2024 Financial Results and Recent Business Highlights – 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 reduc ...
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 ...
Inovio Pharmaceuticals(INO) - 2024 Q3 - Quarterly Report
2024-11-14 21:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO | --- | --- | |-----------------------------------------------------------------------------------------------------------------------|--------------------------- ...