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Here's Why Inovio (INO) Could be Great Choice for a Bottom Fisher
ZACKS· 2025-02-12 15:55
Core Viewpoint - Inovio Pharmaceuticals (INO) has experienced a downtrend, losing 13.2% over the past two weeks, but a hammer chart pattern suggests a potential trend reversal as buying interest may be emerging [1][2]. Technical Analysis - The hammer chart pattern indicates a possible bottoming out, with selling pressure likely subsiding, which could lead to a bullish trend for the stock [2][4]. - A hammer pattern forms when there is a small candle body with a long lower wick, signaling that bears may be losing control and bulls are starting to gain support [3][4]. - This pattern can occur across various timeframes and is utilized by both short-term and long-term investors [4]. Fundamental Analysis - There has been a notable upward trend in earnings estimate revisions for INO, which is a bullish indicator suggesting potential price appreciation [6]. - Over the last 30 days, the consensus EPS estimate for the current year has increased by 22%, indicating that analysts expect better earnings than previously predicted [7]. - INO currently holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, which typically outperform the market [8].
Clinical and Immunological Results from Phase 1/2 Study of INO-3107 as a Treatment for Recurrent Respiratory Papillomatosis Published in Nature Communications
Prnewswire· 2025-02-12 13:00
Core Insights - INOVIO's INO-3107 shows promise as a treatment for recurrent respiratory papillomatosis (RRP), with clinical trial data indicating significant reductions in the need for surgeries among patients [1][2][3] - The Phase 1/2 trial results were published in Nature Communications, highlighting the immunological impact and efficacy of INO-3107 [1][2] - INOVIO plans to submit a biologics license application (BLA) for INO-3107 in mid-2025, aiming for accelerated approval from the FDA [1][6] Clinical Trial Results - 81.3% of patients (26 out of 32) experienced a decrease in surgical interventions post-treatment, with 28.1% (9 out of 32) requiring no surgeries at all [3][5] - The Overall Response Rate, including both Complete and Partial Responses, was 72% [3] - Patients had a median of 4 surgeries in the year prior to treatment, with a median decrease of 3 surgical interventions after dosing [5] Safety and Tolerability - INO-3107 was well tolerated, with 41% of patients reporting treatment-related adverse events, primarily low-grade [3][5] - The most common adverse events included injection site pain (31%) and fatigue (9%), with no severe adverse events reported [3][5] Mechanism of Action - INO-3107 induced T cell responses specific to HPV-6 and HPV-11, including cytotoxic CD8+ T cells, which persisted at week 52, indicating a memory response [3][5] - The treatment engaged both innate and adaptive immune responses, leading to the emergence of new T cell populations that targeted infected tissues [2][3] Regulatory Designations - INO-3107 has received Orphan Drug and Breakthrough Therapy designations from the FDA, facilitating its path to market [6] - The European Commission also granted Orphan Drug designation, and INOVIO has CE-marked its CELLECTRA® delivery device for commercialization in the EU [6] Market Context - RRP is a rare disease primarily caused by HPV-6 and HPV-11, leading to significant quality of life issues and risks associated with repeated surgeries [4] - The standard treatment involves surgical removal of papillomas, but recurrence is common, highlighting the need for effective alternatives like INO-3107 [4][5]
Immune Response Data for INO-3107 to be Presented as a Poster at American Association for Cancer Research Immuno-Oncology (AACR-IO) Conference
Prnewswire· 2025-02-10 13:05
Core Insights - INOVIO announced the presentation of an abstract detailing the loss of detectable HPV-6 in patients with Recurrent Respiratory Papillomatosis after treatment with INO-3107 [1][2] - The abstract will be presented at the American Association for Cancer Research conference focused on immuno-oncology from February 23-26, 2025 [2] - INOVIO specializes in developing DNA medicines aimed at treating HPV-related diseases, cancer, and infectious diseases [3] Company Overview - INOVIO is a biotechnology company dedicated to the development and commercialization of DNA medicines [3] - The company's technology focuses on optimizing the design and delivery of innovative DNA medicines that enable the body to produce its own disease-fighting tools [3]
INOVIO Highlights Anticipated 2025 Milestones and 2024 Key Accomplishments
Prnewswire· 2025-01-09 13:04
Core Insights - INOVIO anticipates 2025 to be a transformational year, focusing on becoming a commercial-stage company and advancing DNA medicines for rare diseases [2][4] - The company plans to submit a biologics license application (BLA) for INO-3107 by mid-2025, aiming for priority review from the FDA [4][6] Anticipated Milestones for 2025 - Submission of BLA to the FDA for INO-3107, which could be the first DNA medicine approved in the U.S. for recurrent respiratory papillomatosis (RRP) [4][6] - Resolution of manufacturing issues expected by February 2025, followed by retesting of the CELLECTRA® device [4] - Initiation of a confirmatory trial at approximately 20 U.S. academic centers, enrolling around 100 patients [4][6] - Submission of a redosing study protocol to the FDA based on recent durability data [4] - Presentation and publication of recent clinical trial data in a peer-reviewed journal [4] Key Accomplishments from 2024 - Reported that 50% of RRP patients treated with INO-3107 achieved a complete response after two years, an increase from 28% in the first year [4][6] - 95% of patients maintained or enhanced their overall response rate after two years [4] - New immunology data demonstrated INO-3107's ability to induce T cell responses against HPV-6 and HPV-11 [4] - No serious adverse events were reported in the Phase 1/2 trial, with most adverse events being mild [4][6] Emerging Pipeline - INO-3112 is set to undergo a Phase 3 trial in collaboration with Coherus BioSciences, focusing on HPV16/18-positive oropharyngeal squamous cell carcinoma [5][6] - INO-4201 is being developed as a potential booster to ERVEBO® with Phase 2 trial protocols to be finalized [5][6] - Ongoing Phase 1 trial for a DNA encoded monoclonal antibody targeting SARS-CoV-2, with first clinical data expected in Q1 2025 [5][6] Corporate Developments - Strengthened balance sheet with over $60 million in net proceeds from equity offerings in 2024 [6] - Appointment of Steven Egge as Chief Commercial Officer, bringing extensive experience in HPV-related diseases and commercial product launches [6][7]
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 ...