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Inovio Pharmaceuticals, Inc. (INO) Presents at H.C. Wainwright 24th Annual Global Investment Conference (Transcript)
2022-09-12 17:10
Inovio Pharmaceuticals, Inc. (NASDAQ:INO) H.C. Wainwright 24th Annual Global Investment Conference September 12, 2022 7:00 AM ET Company Participants Jacqueline Shea - President and CEO Conference Call Participants Brooke Katsof - H.C. Wainwright Brooke Katsof Good morning, everyone and thank you for joining the H.C. Wainwright 24th Annual Global Investment Hybrid Conference from September 12 to the 14, 2022. My name is Brooke Katsof and I'm an H.C. Wainwright analyst. While we are hybrid this year, we're c ...
Inovio Pharmaceuticals(INO) - 2022 Q2 - Earnings Call Transcript
2022-08-10 00:30
Financial Data and Key Metrics Changes - The company finished Q2 2022 with $348.1 million in cash, cash equivalents, and short-term investments, down from $360.4 million as of March 31, 2022 [23] - Total revenue for Q2 2022 was $784,000, compared to $273,000 for the same period in 2021, reflecting an increase due to the delivery of proprietary smart devices related to a contract with the U.S. Department of Defense [24] - Total operating expenses were $104.9 million for Q2 2022, up from $83.5 million in Q2 2021, with a net loss of $108.5 million or $0.46 per share, compared to a net loss of $82.1 million or $0.39 per share in the prior year [25][27] Business Line Data and Key Metrics Changes - Research and development expenses decreased to $56.5 million in Q2 2022 from $70.8 million in Q2 2021, primarily due to lower expenses related to manufacturing equipment acquisition [26] - General and administrative expenses increased significantly to $48.5 million in Q2 2022 from $12.7 million in Q2 2021, largely due to a $26 million increase in legal expenses [27] Market Data and Key Metrics Changes - The company is focusing on advancing its COVID-19 vaccine candidate INO-4800 and HPV-related product candidates, particularly INO-3107, which are seen as having the most potential for reaching the market soon [40][41] Company Strategy and Development Direction - The company is restructuring to align with product development goals, including an 18% reduction in full-time workforce and an 86% reduction in contractors, aiming for a 30% reduction in operating expenses over the next 18 months [8] - The strategic focus remains on advancing product candidates that are closer to market, particularly in the areas of HPV and COVID-19 [40] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of INO-4800 as a heterologous booster, highlighting its ability to elicit immune responses against multiple variants of concern [35][41] - The company is awaiting data from the REVEAL 2 trial for VGX-3100, which will inform future steps for the program [44][58] Other Important Information - The company anticipates a cash burn of approximately $73 million for Q3 2022, with projections extending the cash runway into Q3 2024 [30] - The proposed settlement of a class action lawsuit is expected to involve a $30 million cash payment and $14 million in common stock, pending court approval [28][29] Q&A Session Summary Question: Can you talk about how your COVID strategy has evolved? - The company continues to monitor market factors and believes that heterologous boosters may provide broader protection against variants, positioning INO-4800 as a significant candidate [35][36] Question: What are some surprises and challenges you've encountered? - The focus has been on realigning resources to advance product candidates with the most market potential, particularly in HPV and COVID-19 [40] Question: What kind of data are you looking for in the REVEAL 2 trial? - The company hopes to meet predetermined efficacy and safety endpoints, which will guide the next steps for VGX-3100 [44] Question: What are the next steps for the GBM program? - The company is encouraged by the survival data and is in discussions with partners about future steps [46] Question: What are the regulatory requirements for INO-4800? - Discussions with regulators are ongoing, and specific country names cannot be disclosed at this time [50] Question: Can you provide an update on CELLECTRA device utilization? - The company is using multiple devices for different clinical trials, including the 5PSP and CELLECTRA devices [51] Question: What is the market sizing for MERS, Lassa fever, and Ebola? - The company plans to provide updates on these clinical programs later in the year, emphasizing their global implications [52] Question: Is INO-3107 on track to report results by the end of the year? - Yes, the company anticipates sharing results from the Phase I/II trial in the second half of the year [54]
Inovio Pharmaceuticals(INO) - 2022 Q2 - Quarterly Report
2022-08-09 19:56
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q COMMISSION FILE NO. 001-14888 https://files.reportify.cc/media/p INOVIO PHARMACEUTICALS, INC. (EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER) Delaware 33-0969592 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 660 W. GERMANTOWN PIKE, SUITE 110 PLYMOUTH MEETING, PA 19462 (Address of principal executive offices) REGISTRANT'S TELEPHONE NUMBER, INCLUDING AREA CODE: (267) 4 ...
Inovio Pharmaceuticals, Inc. (INO) CEO Jacqui Shea Present at Jefferies 2022 Global Healthcare Conference (Transcript)
2022-06-08 19:55
Inovio Pharmaceuticals, Inc. (NASDAQ:INO) Jefferies 2022 Global Healthcare Conference June 8, 2022 1:00 PM ET Company Participants Jacqui Shea - CEO Jeffrey Skolnik - CMO Conference Call Participants Roger Song - Jefferies Roger Song Good afternoon, everyone. Welcome to Jefferies Global Healthcare Conference day one afternoon. My name is Roger Song, one of the senior analysts on the biotech research team in the US. Our next presenting company from -- is Inovio and the presenter is the CEO, Jacqui and CMO, J ...
Inovio Pharmaceuticals(INO) - 2022 Q1 - Quarterly Report
2022-05-10 19:59
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 MARCH 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO COMMISSION FILE NO. 001-14888 INOVIO PHARMACEUTICALS, INC. (EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER) Delaware 33-0969592 (State or other jurisdiction of ...
Inovio Pharmaceuticals(INO) - 2021 Q4 - Earnings Call Presentation
2022-03-02 08:57
Company Focus - INOVIO is dedicated to developing DNA medicines and vaccines for infectious diseases, cancer, and HPV-related conditions [5] - The company's technology combines precisely designed plasmids with proprietary smart devices for delivery [5] - INOVIO's DNA medicines can be designed quickly through optimized SynCon® technology [9] COVID-19 and Infectious Diseases - INOVIO is jointly conducting a global Phase 3 trial for INO-4800 with Advaccine, focusing on countries underserved by vaccines [10] - The WHO selected INO-4800 for its global Phase 3 Solidarity Trial Vaccines, enrolling 40,000 participants [11] - Approximately 1 billion doses of Chinese vaccines have been administered to 110 countries, creating a potential market for heterologous boosters [15] HPV Program - In the US, approximately 80 million Americans are currently infected with HPV, with 14 million new infections annually [17] - VGX-3100 Phase 3 REVEAL1 trial achieved statistical significance for primary objective in all evaluable participants: 23.7% in the treatment group vs 11.3% in the placebo group [21] - INO-3107 has completed enrollment of 32 participants in a Phase 1/2 clinical trial for Recurrent Respiratory Papillomatosis (RRP) [25, 26] Immuno-Oncology - In the GBM study, 84.4% of MGMT Unmethylated (Cohort A) and 85.0% of MGMT Methylated (Cohort B) were alive at 12 months [32]
Inovio Pharmaceuticals(INO) - 2021 Q4 - Earnings Call Transcript
2022-03-02 02:19
Financial Data and Key Metrics Changes - The company ended Q4 2021 with $401.3 million in cash, cash equivalents, and short-term investments, a decrease from $411.6 million as of December 31, 2020 [40] - Total revenue for Q4 2021 was $839,000, down from $5.6 million in Q4 2020, and for the full year, revenue was $1.8 million compared to $7.4 million in 2020 [40] - Total operating expenses increased to $106.3 million for Q4 2021 and $303 million for the full year, compared to $34.9 million and $131.5 million for the same periods in 2020 [41] - The net loss for Q4 2021 was $106.9 million or $0.50 per share, and for the full year, it was $303.7 million or $1.45 per share, compared to a net loss of $24.3 million or $0.14 per share in Q4 2020 [42] Business Line Data and Key Metrics Changes - The company completed full enrollment of 192 participants for the Phase 2 trial of INO-4700 against MERS, which is being conducted in Jordan, Lebanon, and Kenya [24] - Full enrollment was also achieved for the Phase 1b trial of INO-4500 for Lassa fever, with 220 participants enrolled in Ghana [25] - Enrollment of 46 participants was completed for the Phase 1b trial of INO-4201 for Ebola [26] Market Data and Key Metrics Changes - The company noted that while over 63% of the global population has received at least one vaccine dose, first dose vaccination rates in certain countries remain below 12% [10] - The company highlighted the ongoing need for improved access to vaccines and boosters globally, particularly in low to middle-income countries [10] Company Strategy and Development Direction - The company plans to seek regulatory approval to amend the primary endpoint for the Phase 3 INNOVATE trial from prevention of all symptomatic disease to prevention of severe disease [12] - The company is evaluating the feasibility of an additional ex-U.S. heterologous boost trial for INO-4800, comparing it to previously approved vaccines [15] - A memorandum of understanding was signed with Colombia's Ministry of Health to explore collaboration in developing and producing vaccines and biopharmaceuticals locally [38] Management's Comments on Operating Environment and Future Outlook - Management emphasized the importance of T cell responses in protecting against severe disease and the durability of vaccine protection [11][23] - The company expressed confidence in the INO-4800 vaccine's ability to maintain T cell responses against various COVID-19 variants, including Omicron [56] - Management is optimistic about the potential of their DNA medicines platform to address global health needs as COVID-19 transitions from a pandemic to an endemic stage [20] Other Important Information - The company completed the 52-week safety follow-up of REVEAL1 participants, showing VGX-3100 remained well tolerated [31] - The WHO selected INO-4800 for the Solidarity Trial Vaccines, a large international randomized control trial [20] Q&A Session Summary Question: Will biomarker data be used in the REVEAL2 trials? - Management confirmed that they are advancing biomarker development with QIAGEN to identify signatures that predict responses to VGX-3100 [50][51] Question: How is the company addressing the INNOVATE trial amid Omicron? - Management stated that they are proactively seeking to amend the trial's primary endpoint and are confident in the vaccine's T cell response against severe disease [55][56] Question: What are the expectations for regulatory approval steps? - Management outlined that amending the primary endpoint involves modifying the protocol and obtaining approvals from regulatory bodies [62] Question: When will results from the Phase 2 trial of the MERS vaccine be reported? - Management indicated that results are expected by Q3 of the current year as enrollment is ongoing [88]
Inovio Pharmaceuticals(INO) - 2021 Q4 - Annual Report
2022-03-01 20:59
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Delaware 33-0969592 (I.R.S. Employer Identification No.) REGISTRANT'S TELEPHONE NUMBER, INCLUDING AREA CODE: (267) 440-4200 SECURITIES REGISTERED PURSUANT TO SECTION 12(B) ...
Inovio Pharmaceuticals(INO) - 2021 Q3 - Earnings Call Transcript
2021-11-10 01:15
Inovio Pharmaceuticals, Inc. (NASDAQ:INO) Q3 2021 Earnings Conference Call November 9, 2021 4:30 PM ET CompanyParticipants Joseph Kim – President and CEO Ben Matone – Senior Director of Investor Relations Peter Kies – Chief Financial Officer Jackie Shea – Chief Operating Officer Laurent Humeau – Chief Scientific Office Jeffrey Skolnik – Senior Vice President of Clinical Development Anza Mammen – Senior Vice President of Clinical Development Kate Broderick – Senior Vice President of Research and Development ...
Inovio Pharmaceuticals(INO) - 2021 Q3 - Quarterly Report
2021-11-09 20:56
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, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO COMMISSION FILE NO. 001-14888 INOVIO PHARMACEUTICALS, INC. (EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER) If an emerging growth company, indicate by check ...