Seeking Alpha • Oct 14

BioVie: Recent Data In Alzheimer's Suggests +100% Upside Potential Within A Year

Summary BioVie recently presented one of the best cognition improvements ever reported in an open label study in Alzheimer’s disease. Further reporting and biomarkers confirmed those improvements, making BioVie a serious contender in the Alzheimer’s space. A Phase 3 readout in Alzheimer’s and three other potential value-driving catalysts will follow within 9 months. In light of possibly huge investor returns over a year’s time, I present the pros, cons, and risks of an investment in BioVie at this time. Thesis On September 7, 2022, BioVie (BIVI) reported what I believe to be the second-best data on cognition ever from an open label study in Alzheimer's disease ((AD)). In a letter to shareholders of October 4, 2022, the company highlighted some data and compared its cognition reporting to that presented by other competitors. The company will present further data at the Clinical Trial in Alzheimer's Disease (CTAD) annual conference to be held November 29-December 2, 2022. The company will present NE3107's Phase 2 data for Parkinson's by the end of 2022. The company seems positive about that data, which could be logical as neuroinflammation is an underlying cause in Parkinson's disease as well. Topline data of its Phase 3 trial before mid-2023. I believe few investors were actually giving the company a serious chance to bring good news beforehand, though scientifically the reported cognition data makes sense. In light of an at-the-market offering and depressed market sentiment, BioVie's results may have gone unnoticed. Though the company does not have a following like others in the space, I believe its data are equally impressive. I believe the next twelve months hold the potential of tremendous investor returns for the company. The risks to that investment will be set out below as well. Introduction BioVie is a biotech company focused on finding treatments for Alzheimer's disease ((AD)), Parkinson's disease ((PD)) and refractory ascites. I have covered the company twice before, on June 7, 2022, and on September 6, 2022. In my first analysis, I have set out the scientific rationale for why I believed that BioVie may be successful in AD. At the time, I wanted to cover BioVie for its similarities to INmune Bio, but without seriously expecting success for lack of biomarkers or sufficient preclinical results to go on. And last month I mentioned how I interpreted BioVie's recent actions as possibly setting up for a successful readout in AD. The day after that coverage, on September 7, 2022, BioVie reported what I believe to be the second-best cognition data ever reported from an open label study in AD. The company additionally presented findings consistent with that data which, I believe, went largely unnoticed. In a letter to shareholders of October 4, 2022, the company highlighted some data. The Scientific Rationale to NE3107's Potential Breakthrough Success Introduction Alzheimer's is a multifactorial disease, meaning that many and sometimes different triggers may be involved in the process of reaching the later stages of the disease, which involve noticeable loss of cognition. The rationale behind NE3107's potential success is that it is targeting two pathways of Alzheimer's disease that may lead to reduction or even reversal of the neurodegenerative process in Alzheimer's disease. Those are neuroinflammation and insulin-resistance, with neuroinflammation seemingly the primary target. Mechanism of Action Slide (Corporate Presentation) In its September 7, 2022 press release, the company considered itself (own underlining): AD research has largely focused on Amyloid Beta ((AB)) and phospho-tau (p-tau) for decades and has resulted in a large number of trials targeting these mechanisms. More recently, however, research focus has shifted towards targeting neuroinflammation, as evidenced by the 23 disease-modifying agents listed in clinicaltrials.gov in 2021 investigating inflammation or the immune system. NE3107 is the only molecule in this group that is pursuing a two-pronged approach targeting both neuroinflammation and insulin resistance. Furthermore, NE3107 is the only molecule in the group that is conducting a potentially pivotal Phase 3 trial (NCT04669028) that is currently underway in mild- to moderate-AD patients with co-primary endpoints of cognition, as measured by the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12), and function, as measured by Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC), whereas 17 other agents are in Phase 2. This Phase 3 trial is expected to provide topline results in mid-2023. Tumor Necrosis Factor Alpha (TNFa) is a cytokine identified as a major regulator of inflammation given that its excessive activation is associated with chronic inflammation. It is considered to be the central mediator of inflammation due to its role at the top of the biochemical pathway that leads to the production of other inflammatory factors such as various cytokines (e.g., IFNg, IL-1b, IL23, IL-4, IL-17), neurotoxic Aβ peptide oligomers, activation of IKK and JNK (that leads to insulin resistance), and others. A large retrospective study analyzing the electronic medical records of 56 million unique patients demonstrated the linkage between TNFa and AD by showing that patients with rheumatoid arthritis and psoriasis taking TNF blocking agents had significantly lower AD risk. Preclinical studies showed NE3107 is a modulator of TNFa production through its ability to modulate the activation of the Extracellular Regulated Kinase (ERK) and Nuclear Factor kappa B (NFkB). By down regulating the activation of ERK and NFkB, NE3107 has been shown to reduce the production of TNFa. I comment on some of those statements below. AD research has largely focused on amyloid beta and phospho-tau On September 28, 2022, Eisai reported that mild AD patients on amyloid-beta antibody lecanemab showed a 27% reduction of cognitive decline on the clinical dementia sum-of-boxes rating scale. 12.5% of treated patients showed signs of ARIA, with 2.8% percent showing symptoms. ARIA stands for amyloid-related imaging abnormalities, a common serious side effect of amyloid-targeting therapies. Though this reporting was generally praised as is the first phase 3 trial of an Alzheimer's drug in a generation to successfully slow cognitive decline, others were more skeptical. Rob Howard, a psychiatrist at University College Londen, stated that it's a really tiny and almost unnoticeable difference from placebo. Research focus has shifted towards targeting neuroinflammation. TNFa is a master regulator of inflammation. Patients on TNFa-blocking medication have a significantly lower risk of AD. Targeting neuroinflammation has already shown promising results in several neurodegenerative diseases. I have considered this across several of my articles at this point. Results seem to improve over time, making the case for truly disease-modifying treatments. BioVie's reporting builds on a well-established scientific framework. Scientific publications on chronic neuroinflammation and detrimental activity of the resident immune cells of the brain in neurodegenerative diseases are released on an almost daily basis. Recent scientific work suggests that AD is an autoimmune disease. Neuroinflammatory pathways in AD (Cells, June 2022) This is an illustration from an article in Cells that appeared in June 2022, which show how amyloid-beta and other factors may trigger the neuroinflammatory NF-kB pathway and the upregulation of pro-inflammatory cytokines. The brain's immune cells themselves also contribute to neuroinflammation through their M1 phenotype. The use of traditional TNF inhibitors, which are not approved for treatment of diseases of the central nervous system, has been shown to correlate with significantly reduced risk for Alzheimer's disease. While inflammatory diseases normally correlate with an increased risk of Alzheimer's disease, a retrospective study of 56 million patients on traditional TNF inhibitors has shown the opposite in patients treated with TNF inhibitors. On September 20, 2022, a similar report came out. In that sense, the scientific background behind BioVie's NE3107 is remarkably similar to that of INmune Bio's (INMB) XPro, in my view the most promising drug candidate for AD and other neurodegenerative diseases. Both companies differ essentially in that BioVie's NE3107 targets both soluble and transmembrane TNFa, whereas INmune Bio's XPro targets soluble TNF alone. The Cognition Data I see the full data including a presentation and explanatory webinar presented on September 7, 2022 as follows. Cognition Data BioVie (Own Work) According to my own calculations, the above reporting would mean that 39% of patients are not improving, divided as follows: Non-improving population BioVie (Own Work) With Cassava Sciences often being considered to have presented the best open label data in Alzheimer's disease so far, I am summarizing two datasets at twelve months as reported by Cassava Sciences below, both from a group of 100 patients and from an earlier group of 50 patients. Of note, Cassava Sciences also only included patients on the mild to moderate AD spectrum. Cognition Reporting Cassava Sciences (Own Work) According to my calculations, that would mean the following for the non-improving patient population: Non-improving patient population Cassava Sciences (Own Work) There are several similarities between both datasets. The same percentage of patients show decline in reporting of both companies, namely 39%. Both datasets show improvement in the overall population. That overall improvement is within the same range (1.04 point improvement at 3 months vs. 1.5 point improvement at 12 months), also taking into account that Cassava Sciences' results seem to be improving with time, which BioVie expects as well. Declines in both companies' less or not responding patient populations seem in line with normal decline in AD patients, which I believe to be important as it could indicate that their drug candidates probably don't do anything negative for possible non-responders. Further Data Confirms The Potential Of Success And Disease-Modification There were no drug-related adverse events. That is consistent with earlier findings, but in contrast with lecanemab and other amyloid-targeting antibodies. BioVie also reported about nine sets of confirmatory data, which I find indicative, some of which were still in the early stages. Correlation between two rating scales A similar pattern of improvements as seen with ADAS-Cog was seen in MCI/mild AD patients when assessing the ADCS-CGIC Global Rating of Change scale. ADAS-Cog and ADCS-CGIC correlation (September 7 presentation) Global Rating of Change Correlation (September 7 presentation) A similar pattern of improvement was also observed using the Quick Dementia Rating Scale - QDRS, with 71% of 17 MCI/mild AD patients improving with a mean change of -1.35. Quick Dementia Rating Scale Correlation (September 7 presentation) Correlations with inflammatory and oxidative signaling Reductions in TNFa after NE3107 treatment are significantly correlated with improvement in cognition. TNF signaling correlation (September 7 presentation) TNF improvements in mild AD patients (September 7 presentation) This could yet again be seen as a confirmation that the neuroinflammatory hypothesis is successful in Alzheimer's. To me, the percentage of around 60% and significant correlation between cognitive results and reduction of TNF could indicate that the drug's anti-inflammatory action has clear effects in about that number of patients, which is consistent with how INmune Bio sees its targeted patient population. NE3107 also appears to be associated with increased glutathione, a master antioxidant and regulator of oxidative stress. Glutathione reporting (September 7 presentation) Correlations with the ratio of p-tau to amyloid-beta NE3107 treatment was associated with trending improvements in the ratio of p-tau:Ab. The ratio of p-tau to Ab42 could predict PET Ab status. P-tau to Ab correlation (September 7 presentation) Improvements in the traditional biomarkers and hallmarks of Alzheimer's disease Improvements in p-tau values in the range of 3% to 5% were reported, with improvements stronger in milder AD patients. BioVie adds that it expects these increases to improve over time. P-tau improvements (September 7 presentation) Modest improvements in CSF Aβ42were also reported. AB42 modest improvements (September 7 presentation) For reference, Cassava Sciences' simufilam had reported an increase of that measure of 14%/17% after 28 days, and 84% after six months of treatment. Early blood flow and oxygen-dependency imaging Arterial spin labeling imaging suggested NE3107 enhances blood flow in the brain Blood flow imaging data one patient (September 7 presentation) BOLD imaging shows NE3107's potential to normalize a hyperactive hippocampus. Oxygen dependency imaging (September 7 presentation) Summary The above data, which I believe to have been largely ignored as it was contained in an extensive slideshow accompanying the press release, could be seen as initial confirmatory proof that NE3107's open label ADAS-Cog12 cognition data does not stand alone, but is consistent with other measures. Reporting not only included measures of different rating scales, but also TNF as a master neuroinflammatory biomarker and glutathione as a master antioxidant. Linking cognition improvements to reduction of TNF is consistent with the drug's mechanism of action. In other words, the drug seems to work as it's supposed to. For me, in a few months' time, BioVie went from a very risky to a more de-risked potential investment in an Alzheimer's cure. It's still a bit risky, but I feel comfortable having a long position at this time, given the potential upside in light of how I would define success. The Potential Upside And How I Define Success In Alzheimer's Disease The potential upside to its current market cap of about $70 million is huge, and I compare that with the recent market reaction on Eisai's news on lecanemab. The market reacted to that news by adding 58% to Eisai's and 40% to Biogen's (BIIB) value. In the latter case, that meant adding more than $11 billion in market value. Other companies with drug candidates targeting Ab followed suit, such as Eli Lilly (LLY), Acumen (ABOS) or Prothena (PRTA). Analysts gave positive recommendations and set sales targets on the basis of a total addressable market of over $60 billion, based on a treatment price of $20,000 per patient and a market of 3 million patients. An analyst at Mizuho expects lecanemab will bring in $8 billion in worldwide peak sales, noting this is pre-50/50 profit split between Biogen and Eisai. Further, the analyst suggested the total addressable market ((TAM)) for lecanemab could be over $60 billion, assuming there are 3 million mild Alzheimer's patients who would be candidates for the drug, and that the treatment is priced somewhere around $20,000 per patient. With more than 6 million Alzheimer's patients in the US alone and over 40 million people worldwide, I believe those numbers are realistic. I would assume a $20,000 treatment per patient for a disease-modifying drug that does better than lecanemab to be realistic. It would be safe to see the potential upside is +100%. But if one were to take the 11 billion market cap gain of Biogen for reference, we are closer to a potential 157,000%. Success at this time could be defined as outperforming the market's current benchmark, i.e. doing better than 27% slowing of decline. In light of the data shared above, stabilization of cognition may seem within reach. Of note, that is also INmune Bio's outspoken goal with XPro. Anavex could still raise that bar when it will present its Phase 3 trial data.

Seeking Alpha • Sep 06

BioVie: Possibly Setting Up For Success With Alzheimer's And Parkinson's Results Imminent

Summary Earlier June coverage of BioVie showed the company’s potential in Alzheimer’s and Parkinson’s. Since that coverage, the company seems to have been set up for success. Readouts in Phase 2 Alzheimer’s and Parkinson’s trials are now imminent. In case of a successful Alzheimer’s readout, BioVie may be furthest advanced in the race for approval with a Phase 3 trial already midway. Though it remains a high-risk investment for me at this time, NE3107 targets validated pathways in neurodegenerative diseases. Thesis I previously covered BioVie on June 7, 2022. BioVie Inc. (BIVI) is a largely underfollowed biotech firm targeting both Alzheimer's and Parkinson's with a same drug, NE3107, and refractory ascites with BIV201. Apart from some articles relating to its IPO in 2019, the company had not been covered further on Seeking Alpha, and coverage on other media is scarce too. For Alzheimer's and Parkinson's, the company is repurposing an anti-diabetes drug candidate recovered from the bankruptcy of Hollis-Eden Pharmaceuticals. In my previous coverage, I had given the company a Buy rating, which I will repeat here, but not a Strong Buy rating for lack of enough biomarker data to go on. BioVie has not yet reported these, but there is a reason for that, and that's about to change. Things seem to be stirring behind the scenes at BioVie. On no particular press release in a down-trending market, the stock has managed to move up considerably. Since my coverage, the company has been highlighting and/or setting up quite some things that may be indicative of what is to come, which I believe to be bullish. I would like to point investors' attention to those recent events in the coverage below. Company Introduction BioVie aspires treatments in Alzheimer's and Parkinson's with its drug candidate NE3107. NE3107 had originally been developed to treat diabetes and inflammatory diseases in 2006 by Hollis-Eden Pharmaceuticals, after which it has been incorporated in Terren Peizer's Neurmedix for the treatment of neurological diseases. Neurmedix has later been incorporated into BioVie, also run by Terren Peizer. In that framework, NE3107 has already been the object of several Phase 2 trials in inflammatory diseases. BioVie claims that within Neurmedix, the drug's mechanism has been further studied and understood, while at the same time, science in neurological diseases was catching up the idea that underlying inflammatory and glia-related pathways may be an important cause of these diseases. With its second drug candidate BIV201, BioVie aspires treatment improvement for refractory ascites. Drug asset overview (Corporate Presentation) For a first coverage of those assets, I would like to refer readers to my previous coverage of BioVie of June 7, 2022. Since that coverage, there has only been one press release from the company, June 23, 2022, announcing patent issuance for its ascites treatment with BIV201, which did not relieve the downward pressure on the share price. BioVie's share price however took a turn for the better since July 1, 2022, and has been moving up since that moment. This is its one-year price chart. One-year price chart (Ycharts for Seeking Alpha) The company's market cap is now $70 million. After a brief overview of the company, I will focus on the recent developments below. NE3107 for neurological diseases as main asset NE3107 is pursuing the reduction of neuroinflammation and insulin resistance in Alzheimer's and Parkinson's patients by inhibiting ERK signaling without compromising immune function. ERK and NFkB slide (Corporate presentation) ERK, or extracellular signal regulated kinase, is an interesting pathway as it blocks NF-κB or nuclear factor kappa b signaling, which in its turn is closely related to TNF signaling. TNF, or tumor necrosis factor, is often considered as the main driver of neuroinflammation. This is valid in my eyes, as ERK plays a prominent role in inflammatory signaling and activation of glial cells, and NF-κB regulates proinflammatory cytokines such as TNF-α, IL-1β and IL-6. Additionally, NF-κB is involved in Aβ and phosphorylated tau, the typical hallmarks of Alzheimer's disease. BioVie itself sets out the different drug targets and molecular pathways involved in the Alzheimer's space as follows. Alzheimer's pathways slide (Corporate presentation) Whereas most of the past research has focused on amyloid oligomers or phosphorylated tau tangles, research in recent years has shown that Alzheimer's disease is triggered by a chronic inflammatory reaction which leads to a dysregulated state of the immune cells of the brain, also called glial cells. Though many different factors may lead to neuroinflammation, targeting one mechanism may lack efficacy. Targeting neuroinflammation instead may be best to prevent disease progression. BioVie alleges that in glial cells, NE3107 essentially shuts down inflammation where it really starts by modulating ERK. In doing so, the production of TNF-alpha is hampered and the cascade of pro-inflammatory factors as a result of that is diminished as well. Old versus new approach slide (KOL webinar on neuroinflammation) Alzheimer's is essentially seen by many of the typical example of ageing and a failing metabolism, meaning a combination of mechanisms of action may yield best results. The inflammation and TNF-pathways seem to be validated to me, as INmune Bio is pursuing them similarly by selectively inhibiting soluble TNF, with outstanding preclinical and clinical results so far, well validated by the scientific field. It is also my understanding that many other drug candidates in the neurodegenerative space have seen good results caused by drugs that lower neuroinflammation, which makes me wonder whether we are not seeing the first results of an identical underlying cause in treating these diseases. Inflammation drives dysregulation slide (KOL webinar on neuroinflammation) BioVie itself considers itself to be part of a set of companies targeting neuroinflammation in Alzheimer's disease, some of which I have covered already such as INmune Bio (INMB) and Athira Pharma (ATHA). INmune Bio's XPro had reduced an entire pre-defined set of more than 30 biomarkers of neuroinflammation, with the ensuing beneficial downstream effects. Neuroinflammation, if properly reduced without affecting normal immune function, is clearly a target. BioVie shows how NE3107 modulates multiple inflammatory targets such as a wide range of cytokines and chemokines. NE3107 drives multiple inflammatory targets (KOL webinar on neuroinflammation) Targeting insulin-resistance is also validated , as several reports implicate type 2 diabetes in Alzheimer's disease. Earlier results also show that NE3107 decreased metabolic dysregulation in type 2 diabetes. NE3107 decreases systems dysregulation (KOL webinar on neuroinflammation) Worthwhile mentioning is that BioVie's own overview of peers in the neuroinflammation-targeting space also mentions better-known companies such as Denali Therapeutics (DNLI), Quince Therapeutics (QNCX) previously called Cortexyme, Cassava Sciences (SAVA) and Annovis (ANVS). Slide on competitors focused on neuroinflammation (Corporate presentation) The above slide mentions, among others, that NE3107 is anticipated to have significant advantages over the competition as its Phase 3 clinical study in Alzheimer's disease is underway. It is worthwhile highlighting that because, if successful in its Phase 2 trial on the basis of information considered relevant, BioVie's market cap could skyrocket in preparation of its Phase 3 readout. The portfolio revenue potential is surely meaningful, with a 7.1 million patient population in Alzheimer's and Parkinson's combined, and >8.5 billion in peak sales potential for both indications. Portfolio revenue potential (Corporate presentation) Biogen's Aduhelm was once thought to be able to reach $10 billion in peak sales over one year alone, but as the drug did not find appraisal both from doctors or patients due to its uncertain effect on cognition and side effects, those hopes were soon slashed. Nonetheless, the potential is there for a successful drug that could prevent decline without side effect. The recent events Clarity on what to expect from the investigator-initiated Phase 2 study in Alzheimer's disease My earlier coverage mentioned four potential catalysts, two of which were imminent, namely a topline Phase 2a readout in Parkinson's disease and advanced imaging data of a Phase 2 Alzheimer's study. I had understood the latter to be merely an imaging study. It however appears to be much more than that. On June 30, 2022, a SEC filing of BioVie included a new corporate presentation. Subsequent to that SEC filing, the stock started to move higher. As I see it, the updated corporate presentation contained two particular differences to the former one. These are the addition to the pipeline of an investigator-initiated Phase 2 study in Alzheimer's which I have highlighted in red below, and an additional slide on that trial showing the identifier on clinicaltrials.gov. Catalysts and timeline (Corporate presentation) Investigator-initiated trial slide (Corporate presentation) This investigator-initiated open-label Phase 2 trial focuses on functional MRI and biomarkers in Alzheimer's patients, but apparently also includes cognition data. I missed the company highlighting that before. The functional MRI measures are change in glutathione levels, change in diffusion tensor imaging - neurite orientation dispersion density imaging, change in arterial spin labeling, change in functional connectivity of the nucleus basalis of meynert, and change in neurovascular coupling. These measures do not tell me much, and I expect the company to elaborate on their importance. I have seen INmune Bio read out several functional MRI measures that have been of great importance to my understanding of the potentially disease-modifying characteristics of their drug, such as apparent fiber density, radial diffusivity and white matter free water. So I am curious to see what BioVie will report here. But I am more curious as to the readout of the additional exploratory endpoints, more specifically readouts on the clinical dementia rating change (QDRS), the Montreal cognitive assessment change (MoCA), the Alzheimer's Disease Assessment Scale - Cognitive Subscale (Adas-Cog11), and the Mini-Mental State Examination (MMSE). Alzheimer's disease being essentially characterized by a constantly declining cognition which ultimately results in loss of function and death, cognition data are important for investors. Cognition data may be indicative of whether a drug candidate stands chances of being successful in a Phase 3 trial. As an example, the possible effect of a readout of a Phase 2 trial on cognition led Casava Sciences' share price to make a tenfold increase over the course of six months, in between January 2021 and July 2021, almost reaching a $5 billion market cap at its peak. And the essential debate between bulls and bears of Cassava Sciences can be reduced to those who look at cognition data primarily versus those who look at scientific integrity. What is now clear is that the company will, early fall of 2021 from the latest update shared on Bloomberg TV, report on both its phase 2 Alzheimer's as its Phase 2 Parkinson's trial. At the same time, the company's CEO called the company 'tremendously undervalued'. That phase 3 trial is actually midway and should read out some time in 2023. BioVie is indeed in the midst of a Phase 3 trial in Alzheimer's without having done a proper Phase 2 trial in Alzheimer's disease. That's not logical, but it would mean that success would place this company about a year away from a pivotal randomized placebo-controlled trial in Alzheimer's disease. When enquired about that recently, the company mentioned the following: This drug was originated a long time ago by a company called Hollis Eden Pharmaceuticals who was developing it for diabetes. And through the long development process eventually they understood that the mechanism of action of the drug is at the central node of inflammation and as a result it plays a bigger role in Alzheimer's than it would as a diabetic drug. So that's why the company took a detour and pursued Alzheimer's instead of just diabetes. […] The phase 2 data that we have on 3107 essentially came from the diabetes trial where we showed that 3107 did everything that you would expect it to do as a diabetes drug, but in addition it showed signals of essentially restoring what we called lots of dysregulation of other systems. So it helps restore not only glucose control but it helps restore things such as your blood pressure and cholesterol and so forth. So many systems that were dysregulated were now getting back into regulation, and if Alzheimer's is the poster child for systemic dysregulation. We also saw a signal that it helped reduce the production of APP and so forth. So those were the factors that we basically saw that led us and the FDA to authorize us to go straight to a phase three study for Alzheimer's from the findings that we have from our phase two in diabetes primarily, because we showed that we can reduce inflammation and reduce insulin resistance, both of which have been shown to be underlying drivers of Alzheimer's. Postponement of Phase 2 trial data of NE3107 in Parkinson's disease until early fall As mentioned in the previous coverage, BioVie is conducting a Phase 2 study in Parkinson's disease. This study is a double-blind, placebo-controlled Phase 2a study assessing safety, tolerability and potential pro-motoric impact in 40 Parkinson's patients on carbidopa/levodopa over 28 days. It started in January 2022 and was supposed to be reported in the second semester of 2022. This date has now been postponed to the early fall. This trial is essentially based on the same rationale as above in Alzheimer's, and preclinical results in showing that NE3107 had a similar effect to levodopa in rodent and marmoset models. The recent SEC filings As results from the above share price chart over the past months, the sole press release that the company has reported over the past three months had no effect on the share price. I do mention above that, for me, this was the last step in finally de-risking the company's asset for refractory ascites. What did make the stock move, and quite considerably even, are recent SEC filings that can be seen to be bullish on the company's future reportings. I also believe the company's delays in reporting on the two Phase 2 trials in both Alzheimer's and Parkinson's may be related to that. Otherwise I see no reason why there would suddenly be a two-month delay in reporting both. It results from a SEC filing of that same day that on July 15, 2022, BioVie has entered into a securities purchase agreement for the private placement of 3,636,364 shares at $1.65 per share, and a warrant to purchase 7,272,728 shares of common stock at $1.82 over the term of five years, for an aggregate purchase price of $6 million. Acuitas Group Holding is 100% owned by Terren Peizer, the chairman of BioVie's board of directors. This transaction has led to the following share distribution within the board of directors. BoD share distribution (SEC filing) Shares reported for Terren Peizer include the afore-mentioned warrants. Shares reported for Mr. Do, Ms. Kim, Mr. Palumbo, Ms. Markham, Mr. Reading, Mr. Berman, Mr. Gorlin, Mr. Hariri Mr. Lang, Mr. Rogich and Mr. Sherman all include different warrants, and options to purchase a total of 1,011,337 if calculated correctly. Those options are all exercisable within 60 days of July 15, 2022, and hence expire on September 13, 2022. Then, on August 31, 2022, another SEC filing showed that BioVie had entered into a sales agreement with Cantor Fitzgerald & Co. and B. Riley Securities, allowing BioVie at any time to sell shares of its common stock for an aggregate offering price of to $20,000,000. In between all those filings, some time before end of August 2022, there was a coverage of BioVie on Bloomberg TV in which the company's CEO alleged the company to be tremendously undervalued. My view here is that these filings could be interpreted as the company setting up for success. It strikes me that, at a time when reporting should have been done on the afore-mentioned two Phase 2 trials and while the company's shares were at an all-time low, the company decided to give out new shares and grant a warrant for not less than 7 million shares at a price close to that all-time low, in a private placement. It is unclear what will happen with all those options that are being held by the company's directors, and that will soon expire. There may or may not be a link with the recent Cantor Fitzgerald and B.Riley agreement. In any case, latter agreement basically allows the company to pick up future funding. It would be logical when the company would do so at a price substantially higher than the current share price, and I believe that may have been the incentive for both underwriters as well. Of note, Mayank Mamtani of B.Riley also covers BioVie with a price tag of $18. That price target has come down from $47 in January of 2021. At that time, BioVie's share price was still $27.91. A patent update on Terlipressin or BIV201 BioVie repeatedly stated that its trials with Terlipressin or BIV201 are investment de-risking in that that drug has already been approved in 40 other countries, but not in the US, for refractory ascites. Refractory ascites is a life-threatening complication of advanced liver cirrhosis, has no approved treatment in the US, and there are no other treatment candidates but Terlipressin. At 50% market penetration in the US, BIV201 could lead to annual sales of $250 million.

CEO maaş yüzdesi	46.04%
CEO görev süresi	5.4yrs
CEO sahipliği	0.4%
Yönetim ortalama görev süresi	5.3yrs
Yönetim Kurulu ortalama görev süresi	1.3yrs

Tarih	Toplam Tazminat	Maaş	Şirket Kazançları
Jun 30 2026	US$1m	US$640k	-US$22m
Mar 31 2026	n/a	n/a	-US$20m
Dec 31 2025	n/a	n/a	-US$17m
Sep 30 2025	n/a	n/a	-US$19m
Jun 30 2025	US$860k	US$618k	-US$18m
Mar 31 2025	n/a	n/a	-US$19m
Dec 31 2024	n/a	n/a	-US$26m
Sep 30 2024	n/a	n/a	-US$27m
Jun 30 2024	US$777k	US$618k	-US$33m
Mar 31 2024	n/a	n/a	-US$37m
Dec 31 2023	n/a	n/a	-US$43m
Sep 30 2023	n/a	n/a	-US$51m
Jun 30 2023	US$2m	US$618k	-US$50m
Mar 31 2023	n/a	n/a	-US$49m
Dec 31 2022	n/a	n/a	-US$41m
Sep 30 2022	n/a	n/a	-US$31m
Jun 30 2022	US$5m	US$300k	-US$26m
Mar 31 2022	n/a	n/a	-US$150m
Dec 31 2021	n/a	n/a	-US$145m
Sep 30 2021	n/a	n/a	-US$143m
Jun 30 2021	US$2m	n/a	-US$184m

İsim	Pozisyon	Görev süresi	Tazminat	Sahiplik
Cuong Viet Do	President	5.4yrs	US$1.39m	0.35% $ 45.8k
Joanne Kim	CFO, Treasurer & Corporate Secretary	7.9yrs	US$497.60k	0.046% $ 5.9k
Joseph Palumbo	Executive VP of R&D and Chief Medical Officer	4.8yrs	US$775.01k	0.080% $ 10.4k
Clarence Ahlem	Senior Vice President of Operations	2.8yrs	Veri yok	Veri yok
Penelope Markham	Senior Vice President of Liver Disease & Long COVID Programs	no data	Veri yok	Veri yok
Denise Smith	Senior Vice President of Manufacturing & Development	7.7yrs	Veri yok	Veri yok
Christopher Reading	Senior Vice President of Alzheimer's Disease Program	5.2yrs	Veri yok	Veri yok
David Morse	Senior VP & Chief Regulatory Officer	no data	Veri yok	Veri yok

İsim	Pozisyon	Görev süresi	Tazminat	Sahiplik
Cuong Viet Do	President	10.3yrs	US$1.39m	0.35% $ 45.8k
Sigmund Rogich	Independent Director	6.3yrs	US$163.61k	0.051% $ 6.6k
James Lang	Independent Chairman	9.8yrs	US$325.90k	0.0092% $ 1.2k
Justina Omokhua	Member of Corporate Advisory Board	1.3yrs	Veri yok	Veri yok
Michael Sherman	Independent Director	9.2yrs	US$326.36k	0.0028% $ 358.1
Kushagra Saxena	Member of Corporate Advisory Board	1.3yrs	Veri yok	Veri yok
Kameel Farag	Independent Director	1.2yrs	US$44.57k	0% $ 0
Tim Gardner	Member of Corporate Advisory Board	1.3yrs	Veri yok	Veri yok
Ugochi Owo	Chair of Corporate Advisory Board	1.3yrs	Veri yok	Veri yok
Casey Woo	Member of Corporate Advisory Board	1.3yrs	Veri yok	Veri yok
Zaldy Tan	Member of Corporate Advisory Board	1.3yrs	Veri yok	Veri yok
Gregory Nguyen	Member of Corporate Advisory Board	1.3yrs	Veri yok	Veri yok

Veri	Son Güncelleme (UTC saati)
Şirket Analizi	2026/09/17 00:09
Gün Sonu Hisse Fiyatı	2026/09/17 00:00
Kazançlar	2026/06/30
Yıllık Kazançlar	2026/06/30

Paket	Veri	Zaman Çerçevesi	Örnek ABD Kaynağı ^*
Şirket Finansalları	10 yıl	Gelir tablosu Nakit akış tablosu Bilanço	SEC Form 10-K SEC Form 10-Q
Analist Konsensüs Tahminleri	+3 yıl	Finansal tahminler Analist fiyat hedefleri	Analist Araştırma Raporları Blue Matrix
Piyasa Fiyatları	30 yıl	Hisse senedi fiyatları Temettüler, Bölünmeler ve Eylemler	ICE Piyasa Verileri SEC Form S-1
Sahiplik	10 yıl	En büyük hissedarlar İçeriden öğrenenlerin ticareti	SEC Form 4 SEC Form 13D
Yönetim	10 yıl	Liderlik ekibi Yönetim Kurulu	SEC Form 10-K SEC Form DEF 14A
Önemli Gelişmeler	10 yıl	Şirket duyuruları	SEC Form 8-K

Analist	Kurum
Mayank Mamtani	B. Riley Securities, Inc.
null null	CG Capital
Jay Olson	Oppenheimer & Co. Inc.

BioVie Yönetim

Yönetim kriter kontrolleri 1/4

Anahtar bilgiler

Son yönetim güncellemeleri

BioVie Inc., Annual General Meeting, Nov 10, 2025

BioVie Inc. Announces Board Appointments

BioVie Inc. Announces Formation of Corporate Advisory Board

BioVie Inc., Annual General Meeting, Nov 07, 2024

Independent Director recently sold US$128k worth of stock

BioVie Inc., Annual General Meeting, Nov 08, 2023

Recent updates

Biovie Announces Topline Results from Phase 2 Address-Lc Trial Evaluating Bezisterim for the Treatment of Neurological Symptoms Associated with Long Covid

Biovie Provides Update on Phase 3 Development Program for Bezisterim in Parkinson’S Disease

BioVie Inc. Announces Completion of Treatment Phase of ADDRESS-LC Trial of Bezisterim for Treatment of Neurological Symptoms Associated with Long COVID

BioVie Reports Topline Results Of Phase 2 SUNRISE-PD Trial Of Bezisterim In Early Parkinson’s Disease

New major risk - Market cap size

BioVie Inc. has filed a Follow-on Equity Offering in the amount of $50 million.

New minor risk - Share price stability

BioVie Inc. Completes Phase 2 Sunrise-Pd Trial In Early-Stage Parkinson’s Disease

New major risk - Financial position

Biovie to Host Virtual KOL Event to Discuss the Phase 2 Study of Bezisterim for the Treatment of Parkinson's Disease Ahead of Topline Data in 2Q26

BioVie Inc Announces Abstract Acceptance For Sunrise-Pd Study On Bezisterim In Parkinson's Disease

New minor risk - Share price stability

New minor risk - Share price stability

BioVie Inc. Completes Enrollment in Phase 2 Sunrise-Pd Trial in Early Parkinson's Disease

New major risk - Market cap size

BioVie Inc., Annual General Meeting, Nov 10, 2025

New major risk - Financial position

BioVie Inc. Highlighted ADDRESS-LC Phase 2 Trial Design Exploring Bezisterim for the Treatment of Neurological Symptoms of Long COVID at Keystone Symposia on Long COVID and Other Post-Acute Infection Syndromes

BioVie Inc. has completed a Composite Units Offering in the amount of $11.999962 million.

New major risk - Market cap size

BioVie Inc. Presents Data Highlighting That Patients Treated with Bezisterim Potentially Experienced an Age Acceleration Advantage Compared to Placebo on 10 Different Biological Clocks at the 2nd World Conference on Aging and Gerontology

BioVie Inc. Announces Board Appointments

Biovie Announces Data Highlighting Bezisterim's Potential to Slow or Reverse Biological Aging and Neurodegeneration Featured as A Keynote Talk At the 7Th World Aging and Rejuvenation Conference

BioVie Inc. to Present Overview of Phase 2 Sunrise-PD Trial at the Advanced Therapeutics in Movement & Related Disorders®? Congress

BioVie Inc. Enrolls First Patient in ADDRESS-LC Clinical Trial Assessing Novel Anti-Inflammatory Candidate Bezisterim for the Treatment of Neurological Symptoms Associated with Long COVID

New major risk - Financial position

BioVie Inc. Announces Formation of Corporate Advisory Board

New major risk - Share price stability

BioVie Inc. Initiates SUNRISE-PD Clinical Trial Assessing Bezisterim in Early Parkinson's Disease with First Patient Enrolled

New major risk - Revenue and earnings growth

Here's Why We're Watching BioVie's (NASDAQ:BIVI) Cash Burn Situation

BioVie Inc. has filed a Follow-on Equity Offering.

Biovie Inc. to Present Design of Planned Phase 2 Study of Bezisterim for the Treatment of Long Covid At Theemystifying Long Covid International Conference

BioVie Inc.'s Upcoming Parkinson’s Disease Clinical Trial Is Fully Funded

BioVie Inc. has completed a Follow-on Equity Offering in the amount of $3.24318 million.

BioVie Inc. has filed a Follow-on Equity Offering in the amount of $3.24318 million.

BioVie Inc. has completed a Follow-on Equity Offering in the amount of $6.00075 million.

BioVie Inc. has completed a Follow-on Equity Offering in the amount of $6.6645 million.

BioVie Inc. has filed a Follow-on Equity Offering in the amount of $6.6645 million.

BioVie Inc. Receives Notice of Allowance for Japan Patent Application Covering Novel Liquid Formulation of Terlipressin

BioVie Inc. Receives Notice of Allowance for United States Patent Application Covering Novel Liquid Formulation of Terlipressin

BioVie Inc. has completed a Follow-on Equity Offering in the amount of $2.995764 million.

New major risk - Market cap size

BioVie Inc. has filed a Follow-on Equity Offering.

BioVie Inc., Annual General Meeting, Nov 07, 2024

BioVie Inc. Secures All Scientific Approvals Needed to Receive Additional $12.6 Million of Grant Funding to Launch Planned Phase 2 Trial to Evaluate Bezisterim in Long Covid

Biovie Inc. Announces Fda Authorization of Investigational New Drug Application for Phase 2 Trial to Evaluate Bezisterim in Long Covid

Biovie Inc. Announces Clinical Data Showing Epigenetic Basis for How Bezisterim May Modulate Inflammation and the Biological Aging Process At the 11Th Aging Research and Drug Discovery Meeting

BioVie Inc. Announces Alignment with FDA on Clinical Trial to Assess Bezisterim in Parkinson’S Disease

New minor risk - Share price stability

BioVie Inc. Presents Protocol Design of Upcoming SUNRISE-PD Phase 2 Trial of Bezisterim in Patients with Early Parkinson's Disease at ATMRD 2024

BioVie Inc. Announces Its Bezisterim Demonstrates Potential Improvements in Sleep/Fatigue and Restless Leg Symptoms for Parkinson’s Disease Patients

New major risk - Financial position

BioVie Awards up to $13.1 Million in Funding from U.S. Department of Defense to Evaluate Bezisterim (NE3107) for the Treatment of Long COVID

BioVie Receives Notice of Delisting from Nasdaq Regarding Non-Compliance with the Minimum Bid Price Requirement Under Nasdaq Listing Rule 5550(a)(2)

BioVie Inc. Announces Pipeline Update and Near-Term Clinical Priorities

BioVie Inc. has completed a Follow-on Equity Offering in the amount of $21 million.

New major risk - Shareholder dilution

Block & Leviton LLP Files A Class Action Lawsuit Against BioVie Inc. and Certain of Its Executives, for Securities Fraud

Independent Director recently sold US$128k worth of stock

New minor risk - Market cap size

BioVie Inc. Announces Efficacy Data from Phase 3 Trial of NE3107 in Patients with Mild to Moderate Alzheimer’s Disease

BioVie Inc. Presents Positive Clinical Safety Data from Phase 2b Trial of BIV201 in Refractory Ascites at the American Association for the Study of Liver Disease (AASLD) - The Liver Meeting® 2023

New major risk - Share price stability

BioVie Announces Late-Breaking Abstract Presenting Clinical Safety Data from the Company's Ascites Phase 2 Trial Accepted for Presentation at AASLD - The Liver Meeting®? 2023

BioVie Inc., Annual General Meeting, Nov 08, 2023

Price target increased by 11% to US$11.50

Insufficient new directors

BioVie Inc. Presents Data for NE3107 At 2023 International Congress of Parkinson’s Disease and Movement Disorders