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Inovio Pharmaceuticals Inc.

TICKER: INO:NYSE.MKT

Inovio Pharmaceuticals Inc. is revolutionizing vaccines to prevent and treat today's cancers and challenging infectious diseases. Its SynCon vaccines, delivered using the company's proprietary electroporation technology, are generating best-in-class immune responses, with therapeutic T cells exceeding other technologies. Inovio's lead vaccine, a therapeutic against HPV-caused precancers and cancers, is in phase 2. Other phase 1 and preclinical programs target prostate, breast and lung cancers as well as HIV, influenza, malaria and hepatitis. Roche and Inovio have an exclusive worldwide partnership to develop and commercialize Inovio's DNA immunotherapies for prostate cancer and hepatitis B.


The information provided below is from analysts, newsletters and other contributors. Please contact the company and visit its website before making an investment decision.

Expert Comments:

Jason Kolbert, Maxim Group (11/17/14) "Inovio Pharmaceuticals Inc. and Roche Holding AG announced that their collaborative agreement for INO-5150 (prostate cancer) has been terminated. . .this change is not significant to our outlook for the company. . .Inovio plans to continue development of INO-5150, starting a Phase 1 trial in H1/15."

Jason Kolbert, Maxim Group (11/17/14) "Inovio Pharmaceuticals Inc. will independently move its VGX-3100 human papillomavirus vaccine to a Phase 3 registration study following positive Phase 2 data in which women showed both histological regression in cervical tissue and viral clearance from the cervix. The company expects end of Phase 2 meetings with the U.S. Food and Drug Administration to wrap up by early 2015 and data to be submitted for peer-reviewed publication."

Jason Kolbert, Maxim Group (11/10/14) "Inovio Pharmaceuticals Inc. will independently move its VGX-3100 human papillomavirus vaccine to a Phase 3 registration study following positive Phase 2 data. . .the company is preparing a manuscript for a major peer-reviewed journal. End of Phase 2 meetings will conclude in 2015, and the Phase 3 could initiate in early 2016."

Charles Duncan, Piper Jaffray & Co. (11/10/14) "We look forward to Inovio Pharmaceuticals Inc.'s initiation of multiple clinical trials and data points before year-end and into 2015 to drive continued investor interest, particularly in VGX-3100 and the Roche Holding AG-partnered programs. . .we'd expect data from these studies in 2015."

Jason Kolbert, Maxim Group (10/22/14) "Inovio Pharmaceutical Inc. announced the Defense Advanced Research Projects Agency has awarded a grant for $12.2M to fund a development of DNA-based monoclonal antibodies (mAbs) for several infectious diseases, including influenza, Pseudomonas aeruginosa, and Staphylococcus aureus. The other collaborators in the studies are the University of Pennsylvania and MedImmune LLC (part of AstraZeneca Plc). We see this collaborative grant as good news that supports our optimism on the Inovio technology."

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Ram Selvaraju, Aegis Capital (10/21/14) "This morning, Inovio Pharmaceuticals Inc. indicated that it would begin targeting product development in three new indications within the context of infectious disease: influenza viral infection, Pseudomonas aeruginosa infection and Staphylococcus aureus infection. . .therefore, in our view, the company is tackling areas of substantial unmet need. We reiterate our Buy rating."

Matthew Smith, Seeking Alpha (10/2/14) "Yesterday, Inovio Pharmaceuticals Inc. gained a lot of attention as investors searched for companies that had Ebola vaccines. . .while the company's vaccine is an early-stage project, it has apparently been quite effective in the two sets of animals it was tested on, being effective in 100% of the cases. This is impressive."

Charles Duncan, Piper Jaffray & Co. (9/25/14) "Inovio Pharmaceuticals Inc. recently announced that it is moving its Ebola DNA vaccine into Phase 1 trials with GeneOne Life Science Inc. . .this Ebola collaboration further supports our thesis that the company's DNA vaccine platform has broad applicability to infectious diseases, as well as precancerous conditions and cancers."

Jason Kolbert, Maxim Group (9/24/14) "Inovio Pharmaceuticals Inc.'s Ebola vaccine candidate, developed from its SynCon DNA vaccine platform, will be moving into a Phase I clinical trial in collaboration with GeneOne Life Sciences. . .a major contributor to viruses spreading is often the virus acquiring mutations that allow it to more easily evade the immune response. A key element in Inovio's candidate is its ability to target multiple strains of the Ebola virus using SynCon vaccine technology."

Jason Kolbert, Maxim Group (9/23/14) "Inovio Pharmaceuticals Inc. announced its Phase 1 clinical trial in patients with aerodigestive cancers. The trial will evaluate the safety, tolerability and immunogenicity of INO-3106. . .this study is part of the company's strategy to broadly expand the clinical development of its DNA-based immune therapy products to treat different human papillomavirus types and the many diseases they cause."

Ram Selvaraju, Aegis Capital (8/11/14) "Inovio Pharmaceuticals Inc. reported financial results for Q2/14. The firm closed the quarter with $109M cash, which we project should be sufficient to fund operations into 2017. . .the firm also announced its intent to move ahead with a Phase 3 pivotal trial of its lead DNA vaccine candidate, VGX-3100, in patients with cervical dysplasia. . .we reiterate our Buy rating and 12-month price target of $19/share. . .the company continues to demonstrate why we believe it to be the preeminent DNA-based immunotherapy company."

Charles Duncan, Piper Jaffray & Co. (8/11/14) "Inovio Pharmaceuticals Inc. reported Q2/14 results this morning, importantly ending the quarter with $109M in cash, which should fund operations through 2017. This excludes the planned Phase 3 for VGX-3100 in cervical dysplasia, for which the company will need additional funding. . .Inovio expects to hold an end-of-Phase 2 meeting with the agency next year and start the Phase 3 in 2016, timelines we believe may prove conservative."

Jason Kolbert, Maxim Group (8/11/14) "Inovio Pharmaceuticals Inc. is reviewing final VGX-3100 data for presentation to the U.S. Food and Drug Administration as part of the end of the Phase 2 meeting and also for submission for peer-reviewed publication, both in early 2015. . .given the results from the Phase 2 trial, we expect the primary endpoint of 36 weeks to be applied in the Phase 3 trial, which we believe could potentiate a quick turnaround and drive a valuation inflection point."

Ram Selvaraju, Aegis Capital (7/24/14) "Inovio Pharmaceuticals Inc. reported positive topline data from a crucial midstage clinical trial of its lead human papillomavirus DNA-based vaccine, VGX-3100, in patients with high-grade cervical dysplasia. The trial met its primary endpoint of histological regression as defined by clearance of CIN 2/3 lesions after six months with robust statistical significance. . .robust immune responses were elicited with this vaccine and the treatment was safe and well-tolerated. . .we believe that the value of the Inovio platform has been substantially enhanced. . . we are upgrading shares of the company from Hold to Buy. . .we believe that Inovio has demonstrated the validity of its vaccine platform efficacy hypothesis and could potentially pursue a partnership with a more established company."

Jason Kolbert, Maxim Group (7/23/14) "Inovio Pharmaceuticals Inc. announced successful results from its randomized, double-blind, placebo-controlled Phase 2 trial of VGX-3100 in women with biopsy-proven cervical intraepithelial neoplasia 2/3 associated with human papillomavirus types 16 or 18. . .we have recently adjusted our model for the 4:1 reverse stock split that establishes a new price target of $18/share."

Charles Duncan, Piper Jaffray & Co. (7/23/14) "This a.m. Inovio Pharmaceuticals Inc. announced positive topline results for its first controlled test of its platform, a Phase 2 study of VGX-3100 in cervical dysplasia. The study met the primary endpoint of reducing/eliminating cervical lesions (p-value <0.025), and we are lowering our discount rate on the program from 25% to 15% as a result of reduced technical/clinical risk, resulting in a new price target of $29 (prior $26)."

Jason Kolbert, Maxim Group (7/15/14) "Inovio Pharmaceuticals Inc. has completed enrollment in the Phase 2 trial (HPV-003) focused on cervical dysplasia; the company expects to report unblinded efficacy and immune response data in mid-2014 (this summer). Inovio has initiated preparatory activities for a potential Phase 3 study and also plans to initiate phase 1/2a studies of VGX-3100 against HPV-caused cervical cancer and head and neck cancer in 2014."

The Life Sciences Report Interview with Charles Duncan (6/26/14) "Inovio Pharmaceuticals Inc.'s VGX-3100 (synthetic constructs of DNA plasmids targeting antigenic proteins expressed by certain oncogenes of human papillomavirus (HPV) subtypes 16 and 18) [is] in a Phase 2 study for cervical dysplasia, or cervical intraepithelial neoplasia (CIN), caused by HPV. . .the trial consists of three immunizations, at zero, three and six months, followed by a readout at nine months. The primary endpoint is regression of cervical dysplasia from CIN grades 2/3 to CIN 1, or to completely normal tissue, at nine months. . .

This trial is important not only for the indication, cervical dysplasia, but also for the broader validation of the technology platform. . .we should appreciate that this is the first human clinical study of the platform that is controlled—it's really the first time we've been able to compare patients treated with this product to a control group. Other studies have been impressive in that they have demonstrated the technology can generate T-cells, but those were not controlled studies. The second thing is that this study is an evaluation of Inovio's clinical trial design capabilities. . . More >

Charles Duncan, Piper Jaffray & Co. (6/24/14) "The most watched, near-term catalyst for Inovio Pharmaceuticals Inc. remains its ongoing Phase 2 in cervical dysplasia, with data expected by the end of July. We expect a Phase 3 to start by year-end if the data are positive and note that the company just initiated a Phase 1/2a for INO-3112 (VGX-3100 plus interleukin-12 plasmid INO-9012) in cervical cancer."

Jason Kolbert, Maxim Group (6/18/14) "Inovio Pharmaceuticals Inc. has completed enrollment in the Phase 2 trial (HPV-003) focused on cervical dysplasia. The company expects to report unblinded efficacy and immune response data in mid-2014 (this summer)."

Charles Duncan, Piper Jaffray & Co. (6/17/14) "Inovio Pharmaceuticals Inc. should report data from the Phase 2 study of cervical dysplasia (CD) of lead VGX-3100 by late July. This is a key data point for the company's platform, as well as potentially informing next steps in CD; being the first Phase 2 data from Inovio, it represents a potential catalyst for it."

Ram Selvaraju, Aegis Capital (6/10/14) "This morning, Inovio Pharmaceuticals Inc. announced the initiation of a Phase 1/2a trial to evaluate the safety, immunogenicity and clinical responses to its lead immunotherapy product, INO-3112. . .in this open-label study, designated HPV-005, up to 20 adults with human papillomavirus-positive head and neck squamous cell carcinoma are to be treated with INO-3112 and followed for safety, immune and clinical responses."

Ram Selvaraju, Aegis Capital (6/9/14) "On Friday, June 6, 2014, Inovio Pharmaceuticals Inc.'s shares of common stock began trading for the first time following the effect of a one-for-four reverse stock split, which took the company's total outstanding shares of common stock down from over 200M to roughly 60M. . .we are raising our price target from $2.50 to $10/share on Inovio."

Brian Klein, Stifel Nicolaus (6/6/14) "Inovio Pharmaceuticals Inc.'s management confirms the VGX-3100 Phase 2 data readout is coming this summer; we believe a positive readout will help validate the company's technology platform. . .we believe active discussions with several potential partners are ongoing and forecast a partnership in 2015, ahead of Phase 3 trial initiation."

Ram Selvaraju, Aegis Capital (5/21/14) "Inovio Pharmaceuticals Inc. recently reported financial results for Q1/14, recording roughly $117M in cash and equivalents on the balance sheet. . .we anticipate that this amount should fund operations at least through 2017, barring more milestone payments from strategic partnerships and other licensing revenue."

Charles Duncan, Piper Jaffray & Co. (5/12/14) "Inovio Pharmaceuticals Inc.'s management guided to data from the Phase 2a in approximately two months and anticipates having a robust set of T-cell data to correlate with the primary efficacy responses. We see this milestone as providing important validation of the platform broadly and may guide a path forward for the cervical dysplasia program specifically."

Jason Kolbert, Maxim Group (5/12/14) "As Inovio Pharmaceuticals Inc. draws closer to Phase 2 proof-of-concept results in the VGX-3100 trial, we believe the probability of a positive outcome is rising. The amount of anecdotal data suggests that the company's combination of vaccine and electroporation delivery does deliver robust T-cell responses; as such, we are lowering our risk rate marginally from 30% to 15%."

The Life Sciences Report Interview with Patrick Cox (5/8/14) "Inovio Pharmaceuticals Inc. continues to thrive. . .the company's approach to cancer is immunotherapeutic. Instead of poisoning the body and hoping that the cancer dies first, Inovio is developing therapies that allow the body to more effectively prevent and fight cancers. This completely disrupts the status quo; it is changing the way we model cancer. . .
Inovio continues to validate the approach developed by David Weiner, acknowledged as the father of DNA vaccines, and Joseph Kim, the CEO of Inovio. The value of the company's platform is evidenced by the participation of Roche Holding AG. That means that Roche's lawyers have vetted Inovio's intellectual property (IP).
A lot of people are working on DNA vaccines. Most of them have nothing that even comes close to replicating Inovio's powerful combination of electroporation [using electrical pulses to gain entry to the cell] and sophisticated plasma constructs. And in the long run, a lot depends upon who can control the patents. Inovio is the product of the merger of the half-dozen most important pioneers in DNA vaccines, including Weiner and Kim. The company controls a massive amount of IP. . .Inovio's vaccine platform aims to increase the productivity and the health of organisms, as opposed to just preventing disease. . ." More >

The Life Sciences Report interview with Charles Duncan (4/24/14) "We have Inovio Pharmaceuticals Inc. rated Overweight. There are some pretty interesting Phase 2 data that could come in roughly midyear. This readout is going to be very important, but Inovio's platform is broadly applicable for both cancers and infectious diseases, as both prophylactic and therapeutic vaccines.

The Phase 2 trial is testing the therapeutic vaccine VGX-3100 in cervical intraepithelial neoplasia (CIN), or cervical dysplasia resulting from human papillomavirus (HPV), the most common sexually transmitted infection in the U.S. This study is arguably the most rigorous test of Inovio's platform thus far, because it is a double-blind, placebo-controlled study. It will be looking at the ability of VGX-3100 to downgrade the dysplasia from CIN 2/3 or CIN 3 to a more normal tissue, CIN 1 or less. Favorable data, I believe, will result in Inovio expanding into head-and-neck cancer, which is also caused by HPV in some patients. This trial could be a major clinical validation of the power of Inovio's broadly applicable platform. Though this is an early-stage story, we'll soon have the greatest validation that the company has had in its history. . ." More >

Jason Kolbert, Maxim Group (3/18/14) "We are raising our price target on Inovio Pharmaceuticals Inc. to $6 from $3. . .as the company draws closer to phase 2 proof-of-concept results in the VGX-3100 trial, we believe the probability of a positive outcome rises."

Jonathan Aschoff, Brean Capital (2/7/14) "Inovio Pharmaceuticals Inc. is differentiated by its use of electroporation in conjunction with DNA in its therapeutic and preventative vaccines. Specific DNA sequences are relatively easy and inexpensive to manufacture and the accompanying electroporation overcomes the hurdle of delivery through the cell membrane. Electroporation temporarily disrupts cell membranes near the injection site, thereby allowing the injected DNA to enter cells and serve as the template for mRNA production and ultimately production of the protein antigens. Without electroporation, cellular uptake of injected exogenous DNA is far less efficient.

Inovio is approaching a key catalyst in Q3/14, that being the phase 2 results for cervical intraepithelial neoplasia (grade 2/3 or 3). We hope and intend to see a difference in histopathological regression of cervical lesions to CIN grade 1 or less between VGX-3100 and placebo. It would also be noteworthy if the trial showed at least as robust of an immune response as was shown at the highest dose in the prior trial, but we believe that most investors are more looking for that first clear indication of clinical efficacy from Inovio's oncology pipeline."

Jason Kolbert, Maxim Group (1/27/14) "Inovio Pharmaceuticals Inc.'s stock performed well last year, as data continued to validate the platform technology (DNA plasmids and electroporation). Further validation came from news last year of the partnership with Roche Holding AG, including $10M up front and milestones of up to $412M plus double-digit royalties."

Biotech Research Group, Seeking Alpha (1/23/14) "Inovio Pharmaceuticals Inc. is about to lay comfortably at the end of the rainbow and swim in a pot of gold. . .currently, the company has an impressive pipeline that has produced intriguing results though its preclinical and phase 1 trials. For instance, Inovio's scientifically evaluated and recent peer-reviewed publication demonstrated stellar results. . .with a healthy cash balance and zero debt, Inovio is a perfect candidate to park some long-term money and watch the fireworks from the sidelines."

The Life Sciences Report Interview with Jason Kolbert (12/17/13) "Inovio Pharmaceuticals Inc. can manufacture a plasmid vaccine in the lab for literally a cost of pennies. . . the company's proprietary electroporation technology allows the plasmid to pass through cell membranes and into cells, which then synthesize the antigens that create a T-cell response. . .

Roche Holding AG just signed a deal earning Inovio $10M upfront and $412M in potential milestones to develop plasmids that will target prostate cancer, as well as hepatitis B. This is an exciting time for Inovio.

TLSR: Jason, in mid-2014 we're expecting to get a readout on Inovio's phase 2 trial testing its VGX-3100 vaccine in 148 patients with cervical intraepithelial neoplasia. What will this event mean for investors?

JK: If those data are compelling, then investors will have to start valuing Inovio not just on the fact that Roche, a major global pharma, seems to be validating its science, but on the real commercial opportunity for its cervical cancer vaccine. . .I think the Roche partnership is probably the first of several to come, because what this little company has is a blueprint of how to manufacture antigens using plasmids. When you think about the number of opportunities that exist for a company like Inovio, it's almost limitless. . .

You and I are taking a lifetime of work by Dr. Joseph Kim, the cofounder and CEO of Inovio, and boiling it down into a nutshell. Sure, if I gave you the recipe for the plasmid, you could go into the lab and make it. But Inovio has the recipe. It knows how to come up with the DNA sequence that will turn on the machinery of a cell to produce a specific antigen or antigens." More >

The Life Sciences Report Interview with Reni Benjamin (12/11/13) "Inovio Pharmaceuticals Inc. [is] developing and advancing DNA vaccines with a twist. The company is both using electroporation, a small electrical pulse, to differentiate [itself] from 'plain vanilla' DNA vaccine players. Inovio is more focused on infectious disease or cancers caused by infectious disease, such as cervical cancer due to human papillomavirus (HPV). Back in September Inovio partnered two preclinical compounds with Roche—one in prostate cancer and one in hepatitis B. OncoSec is more focused on the oncology space, focusing on conditions that have shown huge responses to the immune system, such as melanoma and renal cell carcinoma. [Inovio has] significant phase 2 data due out in 2014." More >

Thom Calandra, The Calandra Report (12/9/13) "Dr. Joseph Kim, the Korean-American laboratory science Ph.D who started San Diego-based Inovio Pharmaceuticals Inc., is an understated powerhouse. . .the company's version of electroporation injection seems to have convinced Roche Holding AG, Merck & Co. Inc. and other pharmaceutical houses to give Inovio a go. We'll know more by June 2014, thanks to FDA results for that phase 2 trial, plus possible scientific papers. By then, if these plasmids, designed using computing power, are the real deal, the shares already will have catapulted. Inovio has $47M cash and no debt."

The Life Sciences Report Interview with Patrick Cox (10/24/13) "Inovio Pharmaceuticals Inc. came out of the work of David Weiner, who discovered how to genetically engineer plasmids, which are circular strings of DNA, to produce any protein that is normally produced by our DNA. We can create artificial DNA with these plasmids to make things like antigens, which alert the immune system to the presence of disease when it's normally hidden, and then cause the immune system to ramp up production of specific kinds of T cells that will allow the effective countering of viral diseases or cancers. This is really an astonishing technology, and that's only the tip of the iceberg.

". . .I'm not at all bothered about the fact that price has gone up. Inovio still has extraordinary potential, and I'll tell you why. Here's one example: Monoclonal antibodies are expensive therapies, and they are difficult to handle, but this technology can actually produce monoclonal antibodies in these little inoculation sites. It puts this code in your body, and you make the antibodies yourself. . .I think that down the road, after Inovio's cancer and virus vaccines have begun to pay off and when the company is able to go where it wants to go, we're going to be looking at monoclonal antibodies, then life-extension technologies, and then other exciting applications. I really want to see Inovio CEO Joseph Kim and Dave Weiner continue to push this technology into the future." More >

Jason Kolbert, Maxim Group (9/25/13) "Inovio Pharmaceuticals Inc. announced a key article has published in Landes BioScience. . .the development of methods to generate therapeutic antibodies and antibody-like molecules in vivo, distinct from an active antigen-based immunization strategy, has considerable clinical utility. . .we believe it is the quality of the company's platform that attracted Roche Holding AG to the recently announced partnership. . .the company represents a new platform technology, 'synthetic vaccines'—engineered vaccines that can be designed for both prophylaxis (prevention) and for therapeutic treatment of T-cell mediated diseases. . .a major advantage of [Inovio's] platform is the process."

Ram Selvaraju, Aegis Capital (9/11/13) "Inovio Pharmaceuticals Inc. announced a partnership deal with Roche Holding AG. . .Roche and Inovio agreed to an exclusive worldwide license agreement to research, develop and commercialize Inovio's preclinical DNA cancer vaccines targeting prostate cancer (INO-5150) and hepatitis B (INO-1800). . .cervical cancer data is the next major catalyst. . .if positive, we believe such results could position Inovio at the forefront of the vaccine field, with evidence of platform validation achieved in both the infectious disease and oncology arenas."

Edward Nash, Cowen & Co. (9/11/13) "Inovio Pharmaceuticals Inc. announced an exclusive worldwide license agreement with Roche Holding AG to develop two DNA-based vaccines. . .both compounds are in preclinical development and have generated robust immune responses in animal models. . .the deal speaks to the strength of Inovio's technology platform. . .we see the possibility of other major pharmaceutical companies following Roche's lead and entering into similar collaboration agreements with Inovio. . .we remain bullish on Inovio shares and reiterate our Outperform rating."

Jonathan Aschoff, Brean Capital (9/10/13) "Roche Holding AG entered into an exclusive agreement to license Inovio Pharmaceutical Corp.'s INO-5150 for prostate cancer and INO-1800 for chronic hepatitis B, as well as the use of Inovio's Cellectra electroporation technology for delivery of the immunotherapies, with Roche funding all product development. . .the $10M upfront payment alone will fund Inovio through Q3/15. . .with its licensing agreement with Roche, we believe Inovio will be able to be more focused on developing its remaining pipeline."

Charles Duncan, Piper Jaffray & Co. (9/10/13) "Inovio Pharmaceuticals Inc. announced this morning that the company has granted Roche Holding AG exclusive worldwide rights to Inovio's DNA vaccines for prostate cancer (INO-5150) and hepatitis B (INO-1800), as well as an option for an additional oncology program. . .besides the good, in our view, financial terms of the deal, the partnership provides further validation of Inovio's platform electroporation/SynCon technologies by one of the leading biopharma companies. We anticipate this to be a longer-term positive for shares and would be buyers even following today's gains; we reiterate our Overweight rating and $3.50 price target."

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