Inovio’s flagship artefact (VGX-3100) for cervical dysplasia acquired by HPV charcoal one of the primary bazaar opportunities. Inovio expects top-line ability and assurance abstracts in 4th division 2020. This should prove to be a cogent agitator if the abstracts is good. Investors are encouraged to watch the arch investigator for VGX-3100 appearance 2 alarm the after-effects in a video advantaged “Kicking Cancer’s Butt” decidedly from the 10-minute mark avant-garde which is appealing able as an able third affair attestant to how the vaccine works. Investors should additionally be acquainted that Inovio is furthering ability during appearance 3 with an bigger commitment accessory which automatically adjusts for anatomy fat ((BMI)) that was not acclimated in appearance 2. Further, a proposed analysis to clarify absolutely who the vaccine will assignment for by agency of biomarkers is actuality developed by Qiagen so that aback Inovio goes to bazaar VGX-3100 the doctors and bloom allowance providers can appoint the vaccine to the citizenry which will best account from its use. One of the surprises which is beneath the alarm for investors is that Inovio performed a 200 accommodating unregistered balloon with VGX-3100 to prove that the vaccine could be stored in a accepted refrigerator rather than acute freezing. This, in turn, could abate the amount of deploying VGX-3100 vaccine to countries breadth freezing vaccines may be difficult.
Inovio partnered with Medimmune/AstraZeneca (AZN) on a added artefact (MEDI0457) which takes Inovio’s flagship artefact (VGX-3100) and adds an allowed accessory alleged IL-12 added AstraZeneca’s own artefact Durvalumab. That added artefact is acclimated to amusement HPV acquired cancers abnormally in the arch and abutting breadth as able-bodied as a added balloon in oropharynx cancer. This added artefact is brash allotment of the “cancer moonshot initiative” and is the acumen why MD Anderson and the National Blight Institute has an absorption in this MEDI0457 product. Inovio expects that there will be a abstracts readout for MEDI0457 about 2nd or 3rd division 2020 although the timing of that abstracts readout is controlled by AstraZeneca who formally owns the abstracts set for this product. The arch and abutting balloon is accepted to complete in August 2020 with a acceptable anniversary acquittal in 2020. Above-mentioned to this artefact actuality partnered, Inovio did a abate balloon of this artefact and begin that 2 patients accomplished abounding absolution with arch and abutting blight such that the beyond balloon abstracts could prove actual exciting.
Staying on the affair of VGX-3100 there are added breach added than cervical dysplasia and arch and abutting and oropharynx cancer. Specifically, there is a balloon to analysis this artefact in HPV-16 or HPV-18 absolute patients who accept vulvar Aerial brand Squamos Intraepithelial Lesion (HSIL) or aerial brand anal lesions. Inovio expects acting abstracts for both of these breach to be arise for appearance 2 in 1st division 2020.
Inovio has been alive on an HIV vaccine for years for altered clades of HIV. Several years ago Inovio arise success on those after-effects and afresh afterwards accumulated these solutions into a “universal HIV” vaccine which covers the predominate clades of HIV. This accepted HIV artefact is alleged Pennvax-GP and Inovio initially arise after-effects a bit over a year ago with about 100% acknowledgment ante and a favorable assurance profile. The Pennvax-GP artefact continues its abstraction in a 60 actuality balloon that is accepted to complete in December 2020 with acting abstracts in 2020. Investors should be acquainted that Inovio is potentially attractive to admixture the Pennvax-GP artefact in the approaching with a monoclonal antibiotic generated from Inovio’s accomplice analysis (Wistar). The abstraction abaft the monoclonal antibiotic is that it will accommodate fast acting analysis for assorted types of HIV admitting the Pennvax-GP will additionally action the best appellation aegis beyond altered clades of HIV. This affair of comboing monoclonal antibodies with best appellation aegis will action afresh aback we awning Zika in the abutting paragraph.
Inovio is appreciative to be the aboriginal aggregation to alpha and complete a beastly analytic balloon for Zika (GLS-5700) which had appearance 1 after-effects in October 2017. There was a consecutive beyond balloon of 160 bodies in Puerto Rico that concluded in 2018 which we apprehend to see abstracts on in 2020. Investors accept been cat-and-mouse patiently for the abstracts on the Puerto Rico balloon but ultimately the abstracts absolution is in the easily of Inovio accomplice Geneone Life Sciences. One of the affidavit for the adjournment is that Puerto Rico was hit by a blow aloof above-mentioned to this balloon ending. However, there are added theories on why abstracts was delayed which is that there were consecutive studies for an Inovio Zika dMab (called INO-A0002). INO-A0002 has been brash as a abundant applicant to admixture with GLS-5700 to accommodate both a fast acting band-aid (dMab) added best appellation aegis (GLS-5700). The fast acting band-aid (dMab) is decidedly important in the aboriginal trimester of a mother’s abundance breadth a abundant mother needs to assure the adolescent from academician deformities acquired by Zika. Men are additionally at accident from Zika as studies advertise that Zika can account ashen testes from this virus. It is accessible that Inovio could get a accrue adjustment of the Zika vaccine or a antecedence analysis agenda (PRV) if it is successful.
Speaking of antecedence analysis vouchers one of the capacity of the aftermost articulation of the aloft branch is a attenuate pediatric disease. Inovio has declared that its abstracts for INO-3106 for a action alleged RRP has the abeyant for actuality a “rare pediatric disease” that could qualify. It is accepted that a analytic balloon for RRP will alpha in 2020. Further, Inovio has been accustomed grants from a affiliation alleged CEPI for the development of a Lassa vaccine which is additionally on the PRV list. And alike added there is preclinical assignment which we altercate in the consecutive breadth with PRV abeyant including tuberculosis, malaria, filovirus (including Ebola), dengue, and chikungunya. For the account of this article, investors should be best aflame about the RRP befalling but investors should additionally be acquainted of these added opportunities for either stockpiling or PRV’s which could be account hundreds of millions of dollars per voucher.
MERS acting abstracts is additionally accepted in 2020. Although MERS is not on the antecedence analysis agenda account this is an communicable ache that infects bodies by way of camels. Saudi Arabia has had abundant outbreaks of MERS in the accomplished which accept been baleful in abounding cases. In 2015 there was additionally a cogent beginning of MERS in South Korea to the point breadth Inovio and its accomplice VGXi became involved. VGXi accurately bureaucracy an Avant-garde Biopharmaceuticals International Centermost of Support (aka “ABICS”) centered about the South Korea MERS outbreak. An broker ability brainstorm that South Korea does not appetite to echo the contest of MERS in 2015 and that South Korea would be accessible to stockpiling Inovio MERS vaccine afterwards after-effects are arise in 2020. We shall see.
Last, but absolutely not least, Inovio expects to advertise 12 months and 18 months all-embracing survivor abstracts for its Glioblastoma ((GBM)) artefact alleged INO-5401 in 2020. The key takeaway actuality for investors is that INO-5401 is accounted as a “universal blight therapy” and could be acclimated in far added breach added than GBM in the future. Added INO-5401 has the abeyant for actuality accumulated with alone therapies such that INO-5401 can “break tolerance” of the allowed arrangement to blight admitting alone therapies such as neoantigens can accommodate a accessory bite to the cancer. Inovio has created a aggregation that is majority-owned by Inovio to do the closing allotment of that aftermost book (provide alone therapies alleged neoantigens). That aggregation is alleged Geneos Analysis and for the time actuality Geneos will not admixture INO-5401 but it is speculated that such a admixture would accomplish faculty in the beyond arrangement of things. The added key takeaway for investors is that in 2019 Inovio arise absolutely absurd after-effects for 6-month progression chargeless adaptation such that the 12-month and 18-month numbers should add to the action and be a key agitator in 2020. Investors should additionally be acquainted that in 2009 the National Blight Institute ((NCI)) prioritized antigens to go afterwards for angry cancer. Figure 2 of that commodity gives a arbitrary of the results. INO-5401 targets the #1 antigen on that account (WT1) as able-bodied as the 11th antigen on that account (PSMA) and additionally the 23rd antigen on that account (hTERT). It is the aggregate of these 3 which Inovio’s accomplice Wistar has articular as actuality the best acceptable to breach altruism to best types of cancers.
An broker should be acquainted that Inovio is not a one-trick pony. There are over 60 vaccine possibilities in the preclinical accompaniment which could become accordant in the new decade as Inovio makes its way forward. As allotment of these assorted possibilities, it is important for an broker to anticipate of Inovio as a “platform” for cures rather than as a distinct artefact category. And to that end, Inovio has bureaucracy a “Platform Development Program” breadth on the aggregation website as allotment of the artefact activity to abode how the belvedere can accompany alternating new solutions. Continued adventure abbreviate if an broker hears that Inovio is authoritative an Ebola vaccine the broker should anticipate of that as actuality a account to authenticate the technology of the belvedere (in the case of Ebola a affirmation of in-vivo monoclonal antibodies (dMab) was achieved) rather than it actuality alone about Ebola itself. As an added account Inovio could accomplish a antecedence analysis agenda for the assignment on Ebola but it is added about the belvedere affirmation than about Ebola itself.
Let’s booty a attending at the opportunities that a belvedere aural Inovio provides:
Although these assorted belvedere opportunities abide for Inovio entering 2020 it is additionally accurate that Inovio requires some technology enablers for the communicable ache amplitude to alleviate the amount of the platform. Specifically, items #1 thru #4 of the belvedere opportunities are in the communicable ache amplitude or anti-microbial amplitude rather than in the blight space. For communicable disease, some patients are abashed of all-overs and could account from a aggravate chargeless commitment system. To that end, Inovio purchased bioject assets for $5.5 actor in 2016. As allotment of that buyout Inovio provided a admission to Texas Tech to abstraction the aqueous dynamics of a aggravate chargeless accessory appliance bioject assets. In 2019 Inovio and Texas Tech arise two science affidavit on what they abstruse from that aqueous dynamics abstraction actuality and here. Entering 2020 it should be accepted that Inovio will added the development of this bioject aggravate chargeless accessory for commitment of its vaccines in adjustment to alleviate the abeyant of belvedere opportunities #1 thru #4 listed above. It is additionally reasonable belief that the conception of a aggravate chargeless commitment accessory could pave the way for the Inovio accepted flu vaccine which is yet accession befalling for Inovio to explore.
South Korea has accurate a admiration to move to Vaccine 3.0 – a new era opened in vaccine analysis and industry. In part, this commodity abstracts “DNA vaccines, criticized to be abortive in humans, are now beneath able-bodied analytic trials in beastly capacity afterwards new electroporation apparatuses were invented” as allotment of the vaccine 3.0 effort. The Hwasun International Vaccine Forum has apparent an absorption in discussing DNA vaccine technology with Inovio’s accurate arm (Dr. David Weiner) which could be a allotment of South Korea and Inovio relations in this area. Aback accumulated with the ABICS which was discussed ahead for acclamation the MERS beginning that occurred in 2015 it is absolutely accessible that South Korea and Inovio could assignment calm to abode the vaccine 3.0 initiative. South Korea additionally has a aggregation alleged Plumbline which Inovio has a cogent actor pale in which sells beastly vaccine products. Inovio and Plumbline are alive on abounding articles calm in the beastly ache amplitude but some of the added arresting efforts are the announcements in 2019 for African Barbarian agitation vaccines and the approval of the barbarian immune-modulator LifeTide SW5 for use in Australia, South Korea, and New Zealand starting in 2020. Last, South Korea has Geneone Life Sciences which is a aggregation that Inovio ally with frequently for vaccine candidates such as MERS and Zika.
The United States has continued accurate a admiration to accept “pharmacy on demand” to minitiarize adaptable biologic manufacturing. The DARPA partnerships with Inovio for Ebola and the development of the dMab belvedere arise to be a abeyant starting point for approaching appliance of Inovio in this area. In a antecedent article, I had accurate that my assumption would be that Inovio would aggrandize aloft this accomplishment with the Pandemic Prevention Belvedere (P3). That belief angry out to be initially incorrect but as mentioned in the belvedere breadth of this article, DARPA has opened up a new befalling alleged the “Nucleic Acids On-Demand Worldwide” ((NOW)) which addresses the aforementioned affair and is an accession to the DARPA P3 platform. To this end, it is accepted that Inovio would accede such programs to added the United States absorption in this area.
China has been actual alive in accepting biopharmaceutical opportunities to bolster China technology to abode assorted bloom issues. Along those lines, Inovio has partnered with ApolloBio to alpha with VGX-3100 as allotment of the China bazaar in accession to added genitalia of the world. It is apparent that there will be added developments with China as Inovio progresses with added articles and added belvedere opportunities. Last, China is the world’s bigger pork customer and yet almost one-quarter of the world’s pigs were wiped out aftermost year due to barbarian flu. As mentioned two paragraphs aloft Inovio and Plumbline are accordingly alive on a vaccine for barbarian flu as able-bodied as an immunomodulator for pig meat alleged Lifetide SW5. The antecedent bazaar for Lifetide SW5 is for pigs in Australia, South Korea, and New Zealand but the China bazaar presents an befalling for bazaar access for the Lifetide SW5 artefact accustomed pig acreage confusion over the accomplished 6 months and accustomed China’s appeal for pork. It would be actual analytic for Inovio and Plumbline to accordingly abode China’s efforts to allurement pig farmers aback to business to accomplish Lifetide SW5 a allotment of the solution.
Japan has been alive with institutional backing in Inovio afresh with investments from Nikko Asset Administration and Sumitomo Mitsui Trust Holdings. Dr. Kim, CEO of Inovio, mentioned Japan in a contempo appointment alarm which could point to added approaching absorption from Japan in Inovio technology.
We accept already gone over assorted opportunities for Inovio to accomplice in the belvedere space. However, there are added areas breadth Inovio has the abeyant to partner. Best of this is belief but there accept been rumors that Regeneron ability be absorbed in licensing the INO-5401 band-aid for Glioblastoma. Further, there accept been breach that Inovio’s hepatitis and prostate blight articles could be partnered. Dr. Kim, CEO of Inovio, has mentioned in contempo appointment calls that he has to be accurate about what he says due to advancing accomplice talks. However, how solid those affiliation talks are a amount of speculation. Some added companies that ability appearance an absorption for partnering accommodate AstraZeneca (a accepted accomplice that ability acquisition added absorption afterwards abstracts for MEDI0457 is revealed), Roche (there accept been rumors that there could be an absorption from Roche afresh in the breadth of prostate cancer), Bristol Meyers, Merck, added partnerships with China businesses such as ApolloBio, and others.
Inovio has had a history of dilutions aback its banknote levels ability about $90 actor which is breadth Inovio’s banknote position is abutting to now. Concoction is a achievability as we access 2020 and some ability alike say that it is probable. The anniversary from AstraZeneca in boilerplate 2020 for MEDI0457 should advice in this attention but it is additionally accessible that anniversary acquittal may access afterwards than adapted to advance banknote position and in that case, Inovio may be affected to dilute. Inovio’s amount per allotment is low which agency that a concoction of a block of shares would be bare at these prices to access the $70 or so actor Inovio would charge to accomplish for 2020 and that is absolutely a accident for bottomward burden on the banal as we access 2020. A mitigating agency for this accident is that there are abounding opportunities for Inovio to accomplice or authorization technology or alike aftereffect Geneos Analysis to access a bigger banknote position afterwards dilution. That said, there accept been agnate opportunities in the accomplished and Inovio has called to adulterate in the accomplished rather than to authorization to accession funds.
One affair that is altered about the armamentarium accession that Inovio performed in 2019 is that it was a convertible chief agenda conception rather than the archetypal dilution. The absorbing allotment of that change in how funds were aloft is that Inovio has the advantage of redeeming the addendum on March 1, 2022, at reasonable pricing. An broker may brainstorm that the aggregation may be in acceptable banking appearance in 2022 to repurchase the addendum and not anatomy a concoction out of that debt. Such banking instruments may be an absorbing another to concoction as Inovio enters 2020 decidedly if Inovio can anticipation that it will accept acceptable levels of allotment in 2022.
Inovio arise in July 2019 that it intends to “sharpen focus on HPV-related diseases and fast-to-market candidates” with a cut in its workforce by 28% and abbreviation anniversary bake amount by 25%. In adjustment to accept this claiming a bit better, it is important to accept how Inovio is organized. Inovio gets its DNA “seeds” or DNA “kernel” from VGXi which Inovio has a cogent actor pale in. VGXi is a accessory of Geneone Life Sciences in South Korea which is a accomplice for vaccines with Inovio. Inovio gets its vaccine account from the Wistar Institute thru the lab of Dr. David Weiner. Meanwhile, Inovio advisers accomplish functions such as architecture and accomplishment of the commitment accessories as able-bodied as analytic balloon administration and additionally the affiliation of the vaccine account from Wistar into analytic artefact conception by Inovio. With that compassionate of the organization, the 28% workforce cut impacts the closing book (design and accomplishment of the vaccine commitment devices, analytic balloon management, and affiliation of vaccine account from Wistar into analytic artefact creation). What is not true, however, is that the 28% workforce cut slows bottomward the conception of vaccine conception account because those account appear from Wistar which had no workforce cuts. So did Inovio absolutely acuminate its focus on HPV-related diseases with this move? That may be what investors appetite to apprehend but the accuracy is acceptable that commitment accessory conception and analytic balloon administration aspects were impacted added so than the vaccine abstraction arm of Inovio. So the absolute adventure may be afterpiece to the “reducing anniversary bake amount by 25%” than it is for cutting focus on HPV. In fact, if you abstraction the opportunities of this commodity Inovio is absolutely adorning its activity rather than cutting its focus.
There could be a added claiming hidden aural the Inovio alignment which is alone arresting by account glassdoor agent reviews. In those reviews, it states that there was a actual claiming with VPs and admiral potentially blank acknowledgment and effective criticism from advisers accomplishing the work. That ability may accept bigger afresh as Inovio has fabricated cogent changes to its VP and administration but it is cryptic to what admeasurement this claiming remains.
Talent assimilation aural Inovio has had a actual claiming which we will present aboriginal followed by a brighter ancillary for added contempo history which we present in the abutting paragraph. If we attending at scientists who already formed for the vaccine abstraction conception arm of Inovio beneath Dr. David Weiner (at Wistar) who afresh transferred to Inovio to assignment there has been abrasion for several of these accomplished scientists who accept larboard for added aggregation opportunities acutely different to Inovio. That abrasion is a bit of a disappointment as the approaching of the aggregation depends on appliance aptitude developed by the vaccine conception arm at Wistar. On the ablaze ancillary of aptitude retention, Wistar itself has done a acutely accomplished job of recruiting and advancement key aptitude over the added contempo accomplished few years. This advance of new aptitude can be apparent by attractive at the new names of scientists added to accurate affidavit acquaint to pubmed as able-bodied as attractive at the awards presented to these new scientists for vaccine account presented in this article. There are several on Dr. David Weiner’s aggregation at Wistar currently who accept excelled in creating some of the vaccine account of this commodity including several of the belvedere technologies. And to that extent, this is acceptable account for Inovio that adolescent aptitude is actuality accomplished and are accidental outstanding results. It is now up to Inovio and Wistar to accomplish abiding that this adolescent aptitude basin is retained.
On January 2nd, 2020 Inovio filed a anatomy 8-K with the SEC accompanying to a almost $4 actor convertible band cable acceding with a Korea based institutional investor. That, by itself, is not a surprise. However, what could be a abruptness to some investors is that aural that anatomy 8-K it was mentioned beneath account 8.01 that the biologics authorization appliance (“BLA”) for VGX-3100 was to be delayed 12 to 18 months from its best contempo guidance. Inovio antecedent advice from 2019 was to book the BLA in 2021. Therefore a 12- to 18-month adjournment would assume to advance a BLA filing in 2022 rather than 2021. That added year of adjournment could be a abeyant claiming for Inovio back it would beggarly that Inovio would charge to armamentarium its advance artefact for an added 12 to 18 months afore accepting licensing approval to advertise the product. If that adjournment is accurate it represents time and money to the aggregation and is a affair that investors should adviser activity forward.
Last, investors should be acquainted that there is action amid Inovio’s “kernel” aggregation (VGXi) and Aldevron. This case could accept implications as to how abounding barter and ally VGXi and Inovio attract. At affair is that VGXi spent two decades developing its technology admitting Aldevron developed its technology in a brace of years which VGXi argues could not accept occurred if Aldevron had not baseborn VGXi barter secrets thru antecedent affairs amid Aldevron and VGXi added Aldevron accepting a above key VGXi agent who knew the barter secrets of VGXi. If VGXi does not win this action afresh Aldevron will be a absolute adversary with VGXi in the plasmid amplitude which may accessible the aperture for Inovio’s antagonism to accept another agency of accepting its solutions which could backbite from Inovio’s affiliation opportunities. On the cast ancillary if VGXi wins the action added opportunities may present themselves to Inovio.
As of January 1st, 2020 Inovio banal amount currently trades abreast the high trend band of the 10-year chart. Further, Inovio’s banal has some drive afterwards it afresh bounced on college than boilerplate aggregate and airtight out of a 1 year declivity channel. The bureaucracy is discussed added in my blog access with cessation no afterwards than end of March 2020 in likelihood.
Inovio has abounding catalysts in 2020 including assorted abstracts readout and belvedere opportunities. Those opportunities accept the abeyant for added partnerships and antecedence analysis vouchers (PRV’s).
Inovio additionally has a set of challenges to affected as it enters into 2020 in the areas of banknote management, agent aptitude retention, accepting the biologics authorization appliance for VGX-3100 filed in a appropriate fashion, and advancing action from an important aggregation to Inovio’s success (VGXi).
See additionally Ronald Surz Positions For 2020: Baby Boomers, Assure Yourselves on seekingalpha.com
The angle and opinions bidding herein are the angle and opinions of the columnist and do not necessarily reflect those of Nasdaq, Inc.
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