Q1 2022 Vyant Bio Inc Earnings Call
Good afternoon and welcome to the Viantbio first quarter 2022 earnings conference call and
Good afternoon, and welcome to the <unk> first quarter 2022 earnings conference call and webcast.
Today, May 16, 2022, the company issued a press release summarizing results for the first quarter 2022 and filed its form.
Today May 16, 2022, the company issued a press release summarizing results for the first quarter 2022, and followed it for.
Today's discussion will provide an overview of activities in the first quarter and 2022 is being recorded. And a replay of the webcast will be available on the Vient Bio website following today's
Today's discussion will provide an overview of activities in the first quarter and 2022 is being recorded and a replay of the webcast will be available on the <unk> website. Following today's call. Alternatively, the link can be sent to you by contacting.
Alternatively, the link can be sent to you by contacting ir at Viantbio.com. All participants on this call will be in a listen only mode during the presentation. The presentation will be followed by a...
Our <unk> volume.
<unk> Dot com all participants on this call will be in a listen only mode. During the presentation. The presentation will be followed by a question and answer session. At this time I would now like to turn the conference over to Jay Roberts, Chief Executive Officer of <unk>. Please go ahead Sir.
At this time, I would now like to turn the conference over to Jay Roberts, Chief Executive Officer of ViantBio. Please go ahead.
Thank you, operator, and thank you all for joining the Vyen Bio Investor Conference call and webcast for the first quarter 2022.
Thank you operator, and thank you all for joining us via the <unk> Investor Conference call and webcast for the first quarter 2022.
We're pleased to have a fresh start to the year for biome bio, beginning in many ways.
We're pleased to have a fresh start to the year for bio <unk> will continue in many ways.
We spent the first quarter fully focused on progressing our scientific research and development business plan. Our call today will articulate some of the scientific insights that we have gained in the quarter along with our financial results.
With the first quarter fully focused on progressing our scientific research and development.
This plan.
Today, we will articulate some of the scientific insights that we have gained in the quarter.
Along with our financial results for the quarter.
As such, on the call with me today is BioM Bio's Chief Financial Officer, Andy LaFrance, and our Chief Scientific Officer, Dr. Robert Fermo.
As such on the call with me today is <unk>, Chief Financial Officer, Andy what brands and our Chief Scientific Officer, Dr. Robert promote.
Following the Safe Harbor Statement, I will start out describing the corporate initiatives we have accomplished so far this year. Then Dr. Primo will provide an overview and update on recent scientific achievements made in the quarter and the vision ahead. Finally, Angela France will take us through a brief financial update and discuss key accounting matters for the first quarter 2022. I will make some closing remarks and then we'll open up the lines for questions. I will now turn the call.
Following the Safe Harbor statement I will start off describing the corporate initiatives, we have accomplished so far this year.
Then Dr. <unk> will provide an overview and update on recent scientific achievements made in the quarter and the vision ahead. Finally, maybe if a branch who will take us through a brief financial update and discuss key accounting methods for the first quarter 2022.
I will make some closing remarks, and then we will open up the lines for questions now.
I'll now turn the call over to our CFO Andy will for us.
Thank you, Jay, and welcome to all. We would like to remind everyone that various comments about future expectations, plans, prospects, constitutes board looking statements for purposes of safe harbor provisions under the Private Security's Legations Reform Act of 1995.
Thank you Jay and welcome to all we would like to remind everyone that various comments about future expectations plans prospects constitute forward looking statements for purposes of Safe Harbor provisions under the private Securities Litigation Reform Act of 1900.
Five.
By bio cost is that these forward-looking statements are subject to risk in certain needs that may cause our actual results to differ materially from those indicated, including risk described in the company's filings with the FEC.
Bio cautions that these forward looking statements are subject to risks and uncertainties that may cause our actual results to differ materially from those indicated including the risks described in the company's filings with the SEC.
Any forward-looking statements made on this conference call speak only of today's date, Monday, May 16, 2022, invite BIO Design Attendant to update any of these forward-looking statements to reflect events or circumstances that would occur after today's date. This conference call is also being recorded for audio re-broadcasts. And by BIO's website at www.vinebio.com.
Any forward looking statements made on this conference call speak only as of today's date Monday May 16, 2022, and <unk> bio design intend to update any of these forward looking statements to reflect events or circumstances that would occur after todays date.
This conference call is also being recorded for audio rebroadcast on <unk>.
Buyers web site at Www Dot <unk> Dot com.
With that, I'd like to turn the call back over to Jay Roberts. Jay.
With that I would like to turn the call back over to Jay Roberts Jay.
Thank you Andy. As we begin the call, I think it's important to remind everyone that we committed to our shareholders during the first quarter of 2022 to solely focus by and by is an emerging global drug discovery company pursuing the discovery and development of novel and repurpose therapeutics to treat neurodevelopmental and neurodegenerative diseases.
Thank you Randy as we begin the call I think it is important to remind everyone.
We committed to our shareholders during the first quarter of 2022 to solely focus volume <unk> is an emerging global drug discovery company.
Sumit, the discovery and development of novel and Repurpose therapeutics to treat Neurodevelopmental and Neurodegenerative diseases.
such as Red Syndrome, CDKL 5 deficiency disorder, or CDD and Parkinson's disease.
Such as Ret syndrome, CDK Alpha deficiency disorders.
Parkinson's disease.
We believe that as we execute our focus strategy to develop and bring important therapeutic assets into our pipeline, we hope to enhance our shareholder value. Let's...
We believe it is.
We execute our focused strategy to develop and bring important therapeutic assets into our pipeline.
Hope to enhance our shareholder value.
Let's begin with a few highlights.
As we've discussed in our previous call, we have four key discovery programs underway. Today, we'll take you through some of our recent scientific data, which Dr. Fremont will discuss in a few minutes.
As we've discussed on our previous call we have four key discovery programs underway.
Today, we will take you through some of our recent scientific data.
Dr. <unk> will discuss in a few minutes.
We entered the first quarter of 2022, focused on bringing a repurposed drug candidate, the YNT0126 into clinical trials in the first half of next year. Our first two novel drug candidates.
We ended the first quarter of 2022 focused on bringing a repurpose drug candidates.
<unk> zero, one through six into clinical trials in the first half of next year, our first two novel drug candidates.
which supported two redisies as we noted, are in lead identification phase of discovery with R&D.
Which supported two rare diseases. We noted are in lead identification phase of discovery with our R&D teams.
We have more work to complete on compound selection through an iterative process, including high throughput screening on our 3D microbrain platform, the application of AI technologies on the chemistry, which is being done by our partners, as well as our own analytics or interrogating the biology to our own proprietary machine learning.
More work to complete on compounds selection.
Iterative process, including high throughput screening on our <unk> micro Briding platform.
The application of AI technologies on the chemistry, which is being done by our partners as well as our own analytics are interrogating the biology through our own proprietary machine learning system.
We're hoping to report our lead candidates for these programs late this year, as we move into the lead optimization phase early in 2023.
We are hoping to report our lead candidates for these programs later this year.
As we move into the lead optimization phase early in 2023.
Well now I want to keep business accomplishments for the first quarter and related action we are taking as we head into the second quarter of 2022.
I'll now highlight the key business accomplishments for the first quarter and related actions. We are taking as we head into the second quarter of 2022.
First, as we discussed on our last webcast, we announced an important collaboration agreement which we entered into with a promising company and scientific team from organotherapeutics, a developer of proprietary, patient-specific organoids that retapitulate Parkinson's disease pathology.
First as we discussed on our last webcast, we announced an important collaboration agreement, which we entered into with a promising company and scientific team from Organotherapeutic a developer of proprietary.
Patient specific organoid recapitulate, Parkinson's disease pathology.
We believe this collaboration will accelerate our ability to discover small molecule therapeutics to treat patients with Parkinson's disease.
The collaboration brings together the respective teams expertise and drug discovery is in human-drive cells, high throughput biology and chemistry, and machine learning based therapeutic design.
The collaboration brings together the respective teams expertise in drug discovery.
Human derived cells high throughput biology, and chemistry and machine learning based therapeutic design.
Together, we will focus on the identification of drug candidates that rescue the Parkinson's disease phenotype through the development of disease length, clinically transplanted, transplantable assays, and biomarkers through multiple molecular, biochemical and cellular methods and applying machine learning techniques to yield unbiased results.
Together, we will focus on the identification of drug candidates.
The Parkinson's disease phenotype. So the development of these late clinically towards light trucks available assays and biomarkers through multiple molecular biochemical and cellular methods and applying machine learning techniques to yield unbiased results.
We know that therapies for disease that affect the C&F are difficult to discover. It requires innovation and exceptional scientific expertise to tackle.
We know that therapies for diseases that affect the CNS or difficult to discover requires innovation and exceptional scientific expertise to tackle.
Our collaboration, like the few others we have entered, is another in a series of strategic moves to focus our efforts while accelerating our position and great discovery. So the use of technologies that allow insight into human biology, fully into discovery of CNS drugs.
Our collaborations with a few others we have entered.
Is another in a series of strategic moves to focus our efforts, while accelerating our position of drug discovery.
The use of technologies that allow insight into human biology.
Early in the discovery of CNS drugs.
Second, we've made a strategic decision earlier this year to further focus our
Second we've made a strategic decision earlier this year to further focus our business and our <unk>.
And our people on drug discovery and move away from providing pre clinical seros.
People on drug discovery and move away from providing preclinical CRM services.
We engaged in investment banking team, a significant experience in transacting pre-clinical contract research organizations to assist us with the best picture of our Vivo Farm pre-clinical services.
We engaged in investment banking team with significant experience in transacting preclinical contract research organizations to assist us with the divestiture of our vivo farm preclinical services business.
We recognize that the Evo form is a well-run business with a skilled scientific staff. Our exit from the pre-connacal Sierra Roan Services business will allow us to put all of our human and capital resources on our R&D efforts to discover and develop therapeutic assets for CMS diseases.
Eagle Ford was a well run business the skilled scientific staff our exit from the preclinical CRM services business will allow us to put all of our human capital resources on our R&D efforts to discover and develop therapeutic assets.
<unk> diseases.
We are currently entertaining several indications of interest from qualified parties and have a robust M&A expression of interest process that we believe will yield a favorable transaction from both sides. Intended result of this transaction will be incremental, non-delutive cash or a balance sheet that provides fuel for our business.
We are currently entertaining several indications of interest from qualified parties and have a robust M&A expression of interest process that we believe will yield a favorable transaction for both sides.
And the result of this transaction will be incremental non dilutive cash to our balance sheet that provides fuel for our business.
We are working hard to do our best to close the transaction in the 60 to 90 days.
We are working hard to do our best to close the transaction in the next 60 to 90 days.
Further, as we noted in prior calls and quarterly reports, we have relocated our R&D facilities in Loya, California to a new location thereby. Now, move is substantially complete.
Further as we noted in prior calls and quarterly reports, we have relocated our R&D facilities and lawyer.
<unk> pointed to a new location nearby.
That move is substantially complete.
We now have Redemonsi and Strong Scientific R&D teams in both of our R&D facilities in Maple Grove, Minnesota and San Diego, California. Progressing on our internal CNS drug discovery pipe.
We now have redundancy and strong scientific R&D teams and bulk of our R&D facilities in Maple Grove, Minnesota, and San Diego, California.
Aggressive on our internal CNS drug discovery pipeline.
Third, we implemented two new financing vehicles to facilitate the raising of additional equity capital at the company's options. The equity line of credit provided to us by Lincoln Park Capital, allowing access to raise up to $15 million, as well as signing an up to 14 and a half million at the market or ATM facility with Canacred Genuity.
Third we implemented two new financing vehicles to facilitate the raising of additional equity capital at the company's option with an equity line of credit provided to us by Lincoln Park capital.
Access to raise up to $15 million as well as signing.
And up to $14 5 million.
Market or ATM facility with Canaccord Genuity.
And he will discuss this further in a few minutes to highlight that our current cash balances, future proceeds from the divestiture of our vehicle farm business and future proceeds from the equity line of credit and ATM are expected to fund operations well into 2020.
Andy will discuss this further in a few minutes to highlight that our current cash balances.
Proceeds from the divestiture of our Eagle Ford business and future proceeds from the equity line of credit.
<unk> are expected to fund operations well into 2023.
For us, we're participating in investor conferences to get our focused vision in front of investors and our shareholders.
Fourth we're participating in investor conferences to get our focused vision in front of investors and our shareholders.
In January , we presented at the HC Wain Red Bio Connect conference. And last week, we participated in the BioNJ, 12th Annual Bio Parkering.
In January we presented at the HC Wainwright <unk> conference.
Last week, we participated in the bio Ajay 12, Daniel Bio partnering conference will also be in Miami next week presenting at the HC Wainwright.
We'll also be in Miami next week presenting at the H.E. Waywright Global Investor.
Mobile Investor Conference I.
I hope that you can join us there. Finally, we're also focusing on additional shareholder engagement during the coming months to communicate our strategy to both retail and institutional investors. With that, I will now turn the call over to our Chief Scientific Officer, Robert Fromeau.
I hope that you can join us there.
Finally, we're also focusing on additional shareholder engagement during the coming months to communicate our strategy to both retail and institutional investors with that I will now turn the call over to our Chief Scientific Officer Robert promo.
Okay.
Thank you, Jay. I am thrilled to have the opportunity to discuss the violent pipeline.
Thank you Jay I am thrilled to have the opportunity to discuss the pipeline.
At ViantBio, we are pioneering a new way to discover medicines for complex neurodevelopmental and neurodegenerative disorders. We have developed a CNS drug discovery platform that combines human, patient-derived organoid models of brain disease, biology at scale, and machine learning to discover novel CNS drug candidates. Most drugs fail in the...
<unk> bio we are pioneering a new way to discover medicines for complex Neurodevelopmental and Neurodegenerative disorders. We have developed a CNS luxury platform that combines human patient derived organoid models, the brain disease biology at scale and machine learning to discover novel CNS drug candidate.
Most drugs fail in the clinic due to lack of efficacy.
This is especially challenging for CNS drug development where the available animal models have poor predictive value.
Especially challenging for CNS drug development with the available animal models have poor predictive value.
Our approach is designed to allow us to identify therapeutic candidates that are active in a human disease setting at the earliest stages of a program, potentially bypassing the need for animal models.
Our approach is designed to allow us to identify therapeutic candidates that are active in a human leukemia setting at the earliest stages of our program potentially bypassing the need for animal models with efficacy.
I have some exciting data to share with you today, which is the validation we have been working on to support the identification of our League Clinical Compound, Vian 0126.
Some exciting data to share with you today, which is the validation we have been working on to support the identification of our lead clinical compound by zero one through six.
Our first two novel drug candidates would support the two rare diseases we noted or in the hit delete identification phase of discovery with our R&D team.
Our first two novel drug candidates with the support the two rare diseases as we noted.
To hit the lead identification phase of discovery with our R&D teams, we have more work to be done on compounds selection through an iterative process, including hydro for screening on our <unk> micro brand platform. The application of AI technologies on the chemistry, which is being done by our joint venture partner and collaboration partners as well as our own animal.
We have more work to be done on compound selection through an iterative process, including high throughput screening on our 3D microbrains platform, the application of AI technologies on the chemistry, which is being done by our joint venture partner and collaboration partners, as well as our own analytics for interrogating the biology through our own proprietary machine learning.
The next for interrogating the biology through our own proprietary machine learning system.
We are hoping to report our lead candidate's food programs late this year and progress to clinical candidate selection early in 2023.
We are hoping to report our lead candidate <unk> program late this year and progressed to clinical candidate selection early in 2023.
We are continuing to refine our focused scientific approach and validating our human-first blood discovery platform. Our scientific team has pioneered the development of organoid models of human brain disease from patient-derived induced pluripotent stem cells that are sufficiently robust and reproducible to be amenable to high-throughput screening.
We are continuing to refine.
Our focus scientific approach and validating our human first discovery platform. Our scientific team has pioneered the development of Organoid models of human brain disease from patient derived induced pluripotent stem cells that are sufficiently robust and reproducible to be amenable to high throughput screening.
The key elements of our strategy is the identification of relevant drug targets based on therapeutic hypotheses that we derive from our investigation of human disease pathophysiology and the use of quantitative biomarkers to provide meaningful human biology-derived preclinical signals of drug efficacy to drive compound identification.
A key element of our strategy is the identification of relevant drug targets based on therapeutic hypotheses that we derive from our investigation of human disease pathophysiology and the use of quantitative biomarkers to provide meaningful human biology drives preclinical signals of drug efficacy to drive compound advancement.
As we established our CNS drug discovery platform, we knew that we needed to employ the most innovative technologies to accelerate our discovery efforts and establish our competitive advantage.
As we established our CNS drug discovery platform, we knew that we needed to employ the most innovative technologies to accelerate our discovery efforts and establish a competitive advantage to this end we established a proprietary technology platform analytics that is purpose built for progressing for processing aggregation of storage of loss.
To this end, we established a proprietary technology platform, Analytics, that is purpose-built for processing, aggregation, and storage of large data files containing digital images of biological activity, primarily derived from our organoid models for use in our downstream data analysis and machine learning models.
<unk> data files containing digital images of biological activity.
Im really derives from our Organoid models for use in our downstream data analysis and machine learning models.
We have developed an efficient process to translate drug experiment designs from the lab into machine-readable format.
We have developed an efficient process to translate drug experiment designs from the lab into machine readable formats.
process large data sets sourced directly from laboratory equipment, and extract unbiased quantified representations of biologically relevant features to enable the characterization of disease states, the profiling of treatment effects, and the assessment of possible toxicity or adverse events.
Large datasets sourced directly from laboratory equipment, and instruct unbiased quantified representations are biologically relevant features to enable the characterization of disease States.
Finding a treatment effects.
From a possible toxicity or adverse events.
Rett syndrome is a rare kinetic autism spectrum neurological disorder that leads to severe impairments affecting nearly every aspect of a child's life, including their ability to speak, walk, eat, and even breathe easily. The hallmark of Rett is near constant repetitive hand movements and seizures. Rett is usually recognized in children between 6 to 18 months as they begin to miss developmental milestones or lose the abilities they had gained.
Ret syndrome is a rare genetic autism spectrum neurological disorder that lead to severe impairments affecting nearly every aspect of a child's life, including their ability to speak.
Mark.
And even breathe easily.
The hallmark of Ret is near constant repetitive hand movements and seizures.
She would be recognized in children between six months to 18 months as they begin to miss developmental milestones or lose the ability as they had game ready.
Red is primarily caused by mutations on the X chromosome in a gene called MECP2.
<unk> is primarily caused by mutations on the X chromosome in a gene called <unk>.
As you can see on this slide, our rep-patient brain steroids exhibit a unique disease-specific functional phenotype that is markedly different from that of cell-to-control organoids and can be measured in a high-throughput fashion using kinetic imaging systems such as slippery.
As you can see on this slide our rep patient brain Sherwood exhibit a unique disease specific functional phenotype that is markedly different from that of healthy control organize and can be measured in a high throughput fashion using kinetic imaging system such as flipper.
We used our ACA and LIDGE program to extract and quantify the disease-specific features of the red-shuried waveforms shown in the spider plot on the right, including things like peak morphology, peak height, and frequency among others.
We used our assay analytics program to extract and quantify the disease specific features of the registered way forums, showing the spider plot on the right.
Things like peak morphology peak height and frequency among others.
As shown on this slide.
Our ability to reproducibly generate that neurosuroys that exhibit consistent and robust functional phenotypic differences across multiple independent experiments provides a basis for our ability to screen for drug candidate that can rescue the disease phenotype.
Our ability to reproduce regenerate neuro steroids that exhibit consistent and robust functional differences across multiple independent experiments provides the basis for our ability to screen for drug candidate that can rescue the disease phenotype.
We currently have two promising ongoing programs focused on RET. Our re-purposing candidate, Vian 0126, and several novel compounds that are directed against two distinct targets that were identified based on a phenotypic screen of the smart library provided to us by the International Repsonum Foundation, screened on our RET patient-derived organoids.
We currently have two promising ongoing programs focused on rent are Repurposing candidate volume 0126, and several novel compounds that are directed against two distinct targets that were identified based on a phenotypic screening of the smart library provided to us by the International restaurant Foundation screens on our Rep patient thrive.
Organised.
This slide shows that by 0126, this is the dose dependent rescue of the Rhett Bunchelal phenotype following chronic treatment that is correlated with target engagement in the Rhett's ferociousness.
This slide shows the bias 0126. So this is the dose dependent rescue of the rep functional phenotype. Following chronic treatment that is correlated with target engagement in the retro drawings.
A spider plot in the middle shows those dependent rescue of individual parameters of the flipper waveform. This data is summarized in the graph on the right, which shows that rescue of individual flipper parameter occurs at nanomolar concentrations of drug and may not need full target engagement. Importantly, via 0126 is known to reach these levels of concentration in the human brain.
The Spider plot in the middle shows dose dependent rescue of individual parameters of the slip away for this date is summarized in the graph on the right, which shows the rescue of individuals zipper parameter.
Occurs at Nanomole concentrations of drug and May not need full target engagement.
<unk> 012, <unk> is known to reach these levels of concentration in the human brain.
The Viant 0126 molecule is a promising repurposing candidate for several reasons.
So if I had 0126 molecules are promising repurposing candidate for several reasons.
The compound is already going to prove by the FDA as a condition enhancing medication for dementia related to Alzheimer's disease. And there are readily available safety data.
The compound has already been approved by the FDA as a cognition medication for dementia related to all timers disease and are readily available safety data.
Violence 0126 exhibits a consistent ghost-dependent rescue of several red disease phenotypes and our rep patients' direct organoids. And we are working with the International Arrested Foundation to file investigation new drug applications for retina-approximated candidate in Q4 of 2022. And the request for a fendrug death of the day.
0126 exhibits a consistent dose dependent rescue of several rep disease phenotypes in Iraq patient derived organoid and we're working with the international Orexin Foundation to file an investigational new drug application for retina permanent candidate in Q4 of 2022 and the requests of orphan drug designation.
We're meeting with the Clinical Trial Committee of the IRS and May to prepare for a pre-ID meeting with the FDA.
Meeting with the clinical trial committee of the IRS us in May to prepare for a pre R&D meeting with the FDA.
We are also pursuing novel contents for RED directed against two additional targets in collaboration with our joint venture partner, Anomaly.
We're also pursuing novel compounds for Rep directed against two additional targets in collaboration with our joint venture partner analyze.
We're applying machine learning to drive compound progression and establishing and vitro binding and sub-a-spunctional assays for these targets to examine the relationship between target potency and degree of phenotypic rest.
We are applying machine learning to drive compound progression and are establishing in vitro binding and cell based functional assays for these targets to examine the relationship between target potency and degree of phenotypic rescue we expect to identify the candidates in 2022 and identify potential clinical candidates in the first half of 2023.
We respect to identify these candidates in 2022 and have identified potential clinical candidates in the first half of 2023.
They're excited by recent evidence we have obtained that both VAM 0126 and our novel Rep candidates act on distinct biochemical targets and exhibit a differentiated mechanism action from the most clinically advanced Reps that are predetermined.
They are excited.
Fitted by recent evidence we obtained that both <unk> and our novel candidates Act on distinct power chemical targets and exhibit a differentiated mechanism of action from the most clinically.
Rep therapeutic candidates.
GD-KL-5 disorder is a neurodevelopmental condition characterized by early onset epileptic seizures, intellectual delay, and motor dysfunction.
Can you tell a heart disorder.
Aero developmental condition characterized by early onset epileptic seizures.
Actual delay and motor dysfunctions.
Although a crucian for proper brain development, the precise target is CDKL5, and its patrophysiological length to patient symptoms are not currently understood.
Although crucifer proper brain development, the precise targets of <unk> five and its patent physiological make the patient symptoms are not currently understood.
While genetic testing is currently available to identify patients that have a mutation in the CTKL-FI gene, limited knowledge of them allowing Catholic physiology has hinted the identification of potential therapeutic targets under the Scabri of Drug Hymn.
While genetic testing is currently available to identify patients that have a mutation in the <unk> gene limited knowledge of the underlying pathophysiology has hindered the identification of potential therapeutic targets and the discovery of drug candidates.
CDD is an ultra rare neurodome disease with a fine undetmetical need with only one recently approved symptomatic treatment.
<unk> is an ultra rare neurodegenerative disease.
On that medical need with only one recently approved symptomatic treatment.
to investigate the selective vulnerability of neurons in C2L5.
Investigate the selective vulnerability of neurons and CDK all five.
patients. We conducted a single nucleus RNA-6 study of CDK-5 mutant versus healthy neurosurgery.
Patient patients we conducted a single nuclear RNA seek study a CD calcified mutant versus healthy neuro steroids, we observed the CDK <unk> hyperscale a hypothetical what the phenotype is correlated with higher levels of expression of synaptic markers and Sydney neurons, which we confirmed by administering <unk>.
We observed the CDK-L5 hyperacetylopathy phenotype is correlated with higher level of expression of synaptic markers in CD neurons, which we confirm by immunostate.
In addition, we observed the higher neuron to asher type ratio and a reduction of expression of markers for inhibitory, Gabbard-Rezignorant.
In addition, we observed a higher neurons astrocytes ratio and a reduction of expression of markers for inhibitory Gaba urgent neurons.
We screened a custom library of approximately 5200 molecules composed of FDA approved drugs, molecules that pass space on clinical trials, and a pen-lapheeditipic screening compounds with the goal to identify both novel drug candidates and potentially repurposing candidates for CD-CAL-FI disorders. Approximately 280 compounds show some degree of rescue of the CD-D hyper-photobility phenotype.
We screened it cost a library of approximately 5200 molecules composed of an FDA approved drugs molecules of past phase, one clinical trials and Panama phenotypic screening compounds with the goal to identify both novel drug candidates and potential repurposing candidates preceded Cal fire disorder.
Approximately 288 compounds show some degree of rescue of the CBD hyperexcitability phenotype.
We conducted further confirmatory screening and identified 40 compounds that produced the full range of efficacy, rescuing the flipper phenotype in a CDKL-5 specific manner. We are currently conducting full-dose response curves to these promising molecules. In addition,
We conducted further confirmatory screening and identify 40 compounds that produced a full range of efficacy rescuing the flip of phenotype and a <unk> five specific manner we.
We are currently conducting full dose response curve for these promising molecules.
In addition in collaboration with our.
with our collaborating partner, CycleChub, we're applying a machine learning approach utilizing Enzylica screening to identify novel candidate molecules for three potential CDV targets that we will screen in our CDV organ ones. We expect to identify potential lead candidates toward the end of 2022 and hope to identify clinical candidates in the first half of 2023.
With our collaborating partner cyclical we are applying a machine learning approach utilizing a silica screening to identify novel candidate molecules for three potential <unk> CTD targets that we will screen in our CBD organized.
We expect to identify potential lead candidates toward the end of 2022 and hope to identify clinical candidates in the first half of 2023.
Parkusin disease is a progressive neurogenic disorder that affects predominantly dopamine-producing neurons in a specific area of the brain called the substantial niagra.
Parkinson's disease is a progressive neurodegenerative disorder that affects predominately dopamine producing neurons.
Specific area of the brain called the substantial migraine.
Parking the Z symptoms generally develops slowly over years and include tremors, muscle rigidity, gain and balance problems, and slow, imprecise movement.
Parkinson's disease symptoms generally develop slowly over years and include tremors muscle rigidity gain a balanced problems on slow emphasizes movements.
The etiology of Parkinson's disease has poorly understood, but it has widely affected the combination of genetics and environmental factors or the cause.
Neology of Parkinson's disease, a poorly understood, but it is widely accepted as a combination of genetics and environmental factors are the cause.
about 10 to 50% of people with PD have a family history of the condition. And family-bent cases can result from genetic mutations in a handful of genes, including buccus fibros, buccus fibrosides, and lark 2 among others.
About 10% to 15% of people with PD have a family history of the condition and family been cases can result from genetic mutations and a handful of genes, including glucose glucose through besides <unk> and mark to among others.
On March 29th, we announced a collaboration with Organa Therapeutics for the answer to work on the identification lead compounds that are expected to be disease modifying in person disease.
On March 29, we announced the collaboration with organic therapeutics to advance our work on the identification of lead compounds that are expected to be disease modifying in Parkinson's disease.
Organic therapeutics has developed several proprietary familial Parkinson's disease, patient-specific organoids that recapitulate Parkinson's disease pathophysiology.
<unk> Therapeutics has developed several proprietary familiar Parkinson's disease patients organize the recapitulate Parkinson's disease pathophysiology.
The collaboration brings together the respective teams, expertise, and drug discovery using human-drive cells, high throughput biology and chemistry, and machine learning-based therapeutic design to gain insights in the patient-specific responses to potential PD drugs.
The collaboration brings together the respective teams expertise in drug discovery using human drive cells high.
High throughput biology, and chemistry and machine learning based therapeutic designed to gain insights into patient specific responses to potential PD drugs.
Sciences from both sites will utilize complex patient-derived 3D-organized models created from reduced-period potent stem cells to identify disease linked clinically-transabled assays and biomarkers from multiple molecular, biochemical and cellular approaches to identify drug candidates at rescue the familial PD phenotype.
Or is this from both sites, we utilized complex patient derived organoid models created from induced pluripotent stem cells.
<unk> disease linked clinical trial assay, some biomarkers through multiple molecular biochemical and cellular approaches to identify drug candidates that rescue the familial PD phenotype.
Our initial focus is on the GBA and LARC-2 familiar mitigation.
Our initial focus is on the GPA and lark too familiar mutations.
by focusing on these familial Parkinson's disease and mutations, respect to identify common causes and potential therapeutic approaches that can be extended to the much larger sporadic patient population.
By focusing intensely on these familial Parkinson's Parkinson's disease applications, we expect to identify common causes and potential therapeutics approaches that could be scheduled for the much larger sporadic patient population. Our teams are actively executing on a research plan that we believe will accelerate our work.
Our teams are active in executing on a research plan that we believe will accelerate our work to discover novel therapeutics for the treatment of PD, of developing disease and practicing about 10 million patients around the globe.
The novel Therapeutics for the treatment of PD, a debilitating disease impacting about 10 million patients around the globe.
In summary, I am very proud of the progress the team has made over the first quarter of 2022. We have become a fully integrated R&D team working seamlessly across two sites in San Diego, California, and Maple Grove, Minnesota. Through the close collaboration of our cross-site and cross-functional biology and data science teams, we have made important discoveries of identifying a differentiated mechanism of action for our repurposed and novel wet-chimbing.
In summary, I'm very proud of the progress. The team has made over the first quarter of 2022, we have become a fully integrated R&D team working seamlessly across two sites in San Diego, California.
Grove, Minnesota through the close collaboration of our cross site in a cross functional biology and data science teams. We have made important discoveries identifying a differentiated mechanism of action for a repurposed and novel candidates.
Finally, the Maple Grove team has successfully completed a transition from doing service-related work to become a fully integrated R&D team, working closely with our San Diego team, to execute on our strategic vision to discover new medicines between neurodevelopmental and neurogenic disorders, major causes of death and disability worldwide. Thank you for your attention. And I now turn the call back over to Andy LaFrance, our CFO .
Finally, the Maple Grove team has successfully completed the transition from doing service related work to become a fully integrated R&D team working closely with our San Diego team.
On our strategic vision to describe the new medicines excuse me Neurodevelopmental and Neurodegenerative disorders major causes of death and disability worldwide.
Thank you for your attention I'll now turn the call back over to Andrew our friends our CFO .
Andy.
Thank you, Bob. Hello, everyone. And thank you again for joining our call. Today, I will review our financial results for the quarter ended March 31st, 2022. First and foremost, we ended the quarter.
Thank you Bob Hello, everyone and thank you again for joining our call today I will review our financial results for the quarter ended March 31, 2022, first and foremost we ended the quarter.
with $16.4 million in cash. We also implemented two new vehicles to facilitate the raising of additional equity capital at the company's options.
With $16 $4 million in cash.
Oxo implemented two new vehicles to facilitate the raising of additional equity capital at the Companys options with the Finalization of the Lincoln Park equity line of credit, allowing us to.
With the finalization of the Lincoln Park Esley Line of Credit, allowing us
to access up to $15 million of capital, as well as not only in a $14.5 million ATM with chemical originality. Our current cash balances, future proceeds from the sale of the Vivo Farm business, and usage of the equity line of credit and ATM are expected to fund operations well into 2023.
To access up to $15 million of capital as well as signing a $14 $5 million ATM, what canaccord genuity, our current cash balances future proceeds from the sale of the vivo farm business and usage of the equity line of credit and ATM are expected to fund.
Operations well into 2023.
During the first quarter of 2022, the copy continued the process of the investing of the Vivo Farm business, which is expected to be completed this year. Therefore, the Vivo Farm business is classified as Health for Sale and its financial information as discontinuing operations.
During the first quarter of 22.
<unk> continued the process of divesting the vivo farm business, which is expected to be completed this year.
Therefore, the vivo farm business is classified as held for sale.
Financial information as discontinuing operations, the company's loss from continuing operations aggregated $4 $4 million in the first quarter of 2022 and included non cash depreciation and amortization.
The company's lost from continuing operations advocated $4.4 million in the first quarter of 2022 and included non-cash depreciation and amortization as well as stock-based compensation of $98,278,000 respectively and one-time severance charges of $437,000.
<unk>.
As well as stock based compensation of 98270, $8000, respectively, and one time severance charges of $437000.
Discontinuing and continuing operations and net loss for the March 31st, 2022 quarter, advocated $4.8 million. It included a non-cash impairment charge of $4.3 million, resulting from change market conditions for contract research organizations from December 31st, 2021 to March 31st, 2022.
Discontinuing and continuing operations net loss for the March 31, 2022 quarter aggregated $4 8 million and included a noncash impairment charge of $4 $3 million, resulting from changed market conditions for contact contract research organizations from.
December 31, 2021 to March 31 2022.
To revenue from continuing operations increased by 49.3% are $100,000 to $303,000 for the three months ended March 31st, 2022, as compared with $200,000 for the three months ended March 31st, 2021.
Total revenue from continuing operations increased by 49, 3% or $100000 to $303000 for the three months ended March 31, 2022, as compared with $203000 for the three months ended March 31 2021.
As we previously noted, we are winding down our revenue generation activities in the first part of 2022 to solely focus our resources on our research and development activities.
As we've previously noted we are winding down our revenue generation activities in the first part of 2022 to solely focus our resources on our research and development activities.
Cost of goods sold service from continuing operations to load $38,000 and $64,000 respectfully for the three month ended March 31st, 2022 and 2021, resulting in cost of goods sold of 40% and 60% respectfully of service revenue.
Cost of goods sold service from continuing operations totaled $38000.
And $64000 respectively for the three months ended March 31, 2022, and 2021, resulting in cost of goods sold of 40% and 60% respectively of service revenue.
Cost of goods sold product cost decreased by 12% or $48,000 to 340,000 for three months ended March 31st, 2022 As compared with $396,000 for three months ended March 31st, 2021
This whole product cost decreased by 12% or $48000 to 340000 for three months ended March 31, 2022, as compared with $396000 for the three months ended March 31 2021.
Research in development expenses increased by 89% or $731,000 to $1.6 million for the three months ended March 31st, 2022, from 820,000 for the three months ended March 31st, 2021.
Research and development expenses increased by 89% or $731000 to $1 6 million for the three months ended March 31, 2022 from 820000 for the three months ended March 31, 2021. This increase is principally.
This increase is principally due to $336,000 of increase payroll related and consulting expenses. A $315,000 increase in research and development activities at our maple grove to solely.
Due to $336000 of increased payroll related and consulting expenses.
$315000 increase in research and development activities at our Maple Grove facility.
and $48,000 of cost related moving to our new facility in California.
And $48000 of costs related to moving to our new facility in California.
Shelling, general, and administrative expenses increased by $128,000 or $1.5 million to $2.8 million for the three months and did March 31st, 2022. As compared with $1.2 million for the three months and did March 31st, 2021.
Selling general and administrative expenses increased by $128000 or $1 5 million to $2 8 million for the three months ended March 31, 2022, as compared with $1 $2 million for the three months ended March 31 2021.
The 2021 period reflects the company as a privately held company, whereas the 22 period reflects the company as a publicly held company.
2021 period reflects the company as a privately held company, whereas the 'twenty two period reflects the company as a publicly held company.
The quarter ended March 31st, 2022 includes incremental $564,000 of payroll-related expenses, including the one-time contractual severance benefits for two former employees of $437,000. The company incurred incremental professional service fees of $472,000 in the first quarter of 2022, as compared with the same prior year paired related to accounting audit and other professional services.
The quarter ended March 31, 2022 includes incremental $564000 of payroll related expenses, including the onetime contractual severance benefits for.
Our two former employees of $437000.
The company incurred incremental professional service fees of $472000 in the first quarter of 2022 as compared with the same prior year period related to accounting audit and other professional services.
and incurred $418,000 of additional insurance expense as a public company.
We incurred $418000 of additional insurance expense as a public company.
I will close for now and hand presentation over to J. Roberts for closing remarks. Okay?
I will close for now and hand presentation over to Jay Roberts for closing remarks Jay.
Thanks Andy. As we come to the final part of today's call, I'd like to conclude with the following take away.
Thanks, Andy.
Come to the final part of today's call I'd like to conclude with the following takeaways.
First, I'd like to reiterate how pleased we are with the progress our scientific teams are making on multiple fronts related to the existing programs we discussed today. Their activities in the first quarter focus purely on establishing violent bios foothold in the biotech industry and helping to fuel our activities into the future quarter and the near beyond. Second, we believe the total
First I'd like to reiterate how pleased we are with the progress our scientific teams are making on multiple fronts related to the existing programs. We discussed today and our activities in the first quarter focused purely on establishing <unk> foothold in the biotech industry and helping to fuel our activities into the future quarter and the year before.
Sure.
Second we believe the total addressable markets.
and the true rare disease categories where we are focused is approximately $2 billion worldwide. And in the familial parkings in there, the address will mark is over five billion globally. So we take our positioning in the competitive landscape and CNF disorders is highly favorable. Stay tuned.
And the two rare disease categories, where we're focused is approximately $2 billion worldwide and in the familial Parkinson's area. The addressable market is over 5 billion globally. So we think our positioning and the competitive landscape in CNS disorders is highly favorable.
Stay tuned.
As we continue to make progress and also invite listeners to become more familiar with by Empire is news and information becomes available we'll be communicating updates via press releases late in <unk>.
Also inviting listeners to become more familiar with but by and by. As news and information becomes available, we'll be communicating updates. The press releases linked in our by and by website and other social media.
But our website and other social media outlets.
Interested parties are invited to sign up for pressroom this distribution list. Please visit our website. With that, I invite Andy and Bob to join me as we open up the line for Q&A, operating.
Interested parties are invited to setup a press release distribution list. Please visit our website with that I invite Andy to join me as we open up the line for Q&A operator.
Ladies and gentlemen, the floor is now open for questions. If you have any questions or comments, please press the star war on your phone at this.
Thank you ladies and gentlemen, the floor is now open for questions. If you have any questions or comments. Please.
One on your phone at this time.
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Thank you. Your first question is coming from Ed White of HC Wainwright Ed. Please post.
Thank you. Your first question is coming from Ed White of H C. Wainwright. Please pose your question.
Good afternoon. So just a question on zero one.
Hi, good afternoon.
So just a question on.
0126.
You had mentioned previously that you were going to meet with KOLs and hope to draft plans for a pre-IND meeting with the FDA. I believe you had expected to make the request and may or June . I'm just wondering if you can give us an update on heavy worry done that or what your plans are for meeting with the FDA.
You had mentioned previously that you were going to meet with.
Kols and hope to craft plans for a pre IND meeting with the FDA.
I believe you had expected.
The request in May or June I'm, just wondering if you can give us an update on <unk>.
Have you already done that or what your plans are for meeting with the FDA.
Yeah, Ed. So the meeting isn't set up yet, but we are getting ready. And in conjunction with the International Rest Fund, Red Foundation that Bob had talked about, that's going to be part of that process, but we are intending to stay on that schedule that you just define. Perhaps Bob, you have wanna add a little bit more detail to that.
Yes, so meeting isn't set up yet, but we are we are.
Getting ready and in conjunction with the international restaurant recommendation that Ed talked about.
Going to be part of that process, but we are intending to stay on that schedule that you just defined.
Perhaps Bob do you have.
Want to add a little bit more detail to that.
Sure, we have a meeting scheduled with the clinical trial committee of the IRSF on May 23rd to review our clinical development plan for 0126. And we expect to submit our request for a pre-unday meeting at the end of June , early July at the late night.
Sure we have a meeting scheduled with the clinical trial committee of the IRS.
May 23 to review our clinical development plan for zero, one through six and we expect to submit our request for <unk>.
Pre IMD meeting at the end of June .
July I believe.
and we're discussing progress initially. It's going to adult clinical trial as just done with the
And we are discussing.
<unk> initially into an adult.
I'll ask just on the phone.
to advance clinical candidates and then to establish the JuVie talk data we need to get into the pediatric population. That's the follow-on.
To advance clinical candidates and then to establish that Julie talked to here, we need to get into the pediatric population.
If a follow on.
Great. Thanks, Bob.
<unk>.
Another question if I may.
You had mentioned in the past potentially targeting Huntington's disease. I was just curious if you've made any progress or have any plans.
For that indication.
So, that's a big question, thanks. So we are very focused on these two red diseases and Parkinson's.
So.
Thats a great question. Thanks. So we are very focused on these two rare diseases and Parkinson's and given this really strong interest in focusing on neuro degenerative and neurodevelopmental.
Mental diseases.
That's the place where we're gonna put all of our energy and obviously our capital and human resources will focus there for this foreseeable future. And then to the extent that we find other disease targets of interest.
That's the place where we're going to put all of our energy.
So our capital and human resources will focus there.
This foreseeable future and then to the extent that we find other.
Other disease targets of interest.
We'll certainly be talking about that more but at the moment.
We really we really do think it's important that we focus in.
These four programs that we've talked about today.
Okay, thanks, Jay. And perhaps the question for Andy, you mentioned the two financing vehicles. I'm just curious if you've kept them yet this quarter. No, we haven't. No, we have not.
Okay, Thanks, Jay and perhaps a question for Andy.
You mentioned the two financing vehicles I am just curious if you've tapped them yet.
This quarter.
No we haven't.
No we have not.
Okay. Thank you.
That's all the questions I had thanks a lot.
Thanks, Ed.
As a reminder, ladies and gentlemen, if you wish to ask a question. Please press star one on your telephone keypad.
or remind your ladies and gentlemen if you wish to ask a question please press star one on you.
Okay. Our next question is coming from Michael Morrison of West Park Capital Michael <unk>.
Okay, our next question is coming from Michael Mortensen of West Park, Capital.
Yes, folks, thank you for taking my call. My concern is, first of all, I've got two questions.
Folks. Thank you for taking my call.
My concern is first of all I've got two questions.
has nest that contact you in regards to being below $1. $1.
As NASDAQ contacted you in regards to being below a dollar.
Stop.
Hey Mike, hi, this is Jay. So yeah, so no, we have not yet heard from last second's point. Well, you know, that's inevitable, right? At this place.
Hey, Mike Hi, This is Jay so yes, so no we have not yet heard from that effect at this point.
Well that's inevitable right at this price.
We of course don't know what might happen tomorrow.
Well, the requirement, that is that you've got to require the trade above the dollar and with that the market.
Well there are requirements NASDAQ has got a requirement to trade above a down there and whether or not the market.
I mean, it's almost gonna be below a dollar unless nothing spectacular happens.
I mean, it's almost going to be below one dollar unless something's, but tactical happens.
And then of course from there, could become a potential reversed split, which is never good for the shareholders. And I'm just wondering, we're all of this great technology and stuff is gonna benefit us because, again, unless of course this meeting with the FDA and my last question would be, how tune will they compensate you back after that meeting? Because it's just, whether that the market hitting the stock already below a dollar.
And then of course from there could become a potential reverse split which is never good for the shareholders and I'm, just wondering where all of this great technology and stuff is going to benefit us because.
Again unless of course this meeting with the FDA and my last question would be our team will contact you back after that meeting.
Because it's just with an at the market hitting the stock already below a dollar.
to get it above that by what I mean, again, you'll get six months, but
To get it above that level, I mean, again, you'll get six months, but.
I just don't see it. I'm just wondering how a shareholder is going to benefit from everything that's going on with their investment.
I, just don't see and I'm, just wondering how shareholders is going to benefit from.
We think thats going on with their investment.
Yeah, so as we talked about today, Mike, we're very optimistic, but...
Yes, so as we talked about today Mike.
We're very very optimistic, but quite happy with the results of our scientific team.
Quite happy with the results of our scientific team. And we're keeping our head down. We're very focused on the business.
Keeping our head down we're very focused on the business.
We've made meaningful changes in terms of focusing in neurological diseases, because that was an important step for us, continuing to just put our effort and time and energy into executing on our business plan. And we believe that we're on schedule and on time, as it relates to that, so the execution side of this is actually working as we have planned.
We've made meaningful meaningful changes in terms of focusing and neurological diseases. We think that was an important step for us continuing to.
To put our effort and time and energy into executing on our business plan.
We believe that we're on schedule on time as it relates to that sort of the execution side of this is actually working as we have planned.
Okay, so if this FDA meeting takes place on May 23rd, how soon could we expect the risk?
Okay. So if this FDA meeting takes place on May 23rd.
How soon could we expect the response from the FDA.
Bob, you want to handle that, but we believe that it's like a 90 to 120 day window.
Bob do you want to handle that but we believe that it's like 90 to 120 day window.
The meeting on May 23rd is with the International Red Sin in Foundation Clinical Trial Committee. We'll request a pre-ID meeting end of June .
The meeting on May 23rd is with International Ret Syndrome Foundation critical trial Committee will request.
The meeting end of June and then two months later, we will have the R&D meeting, which we anticipate will be in the <unk>.
And then two months later, we'll have the IED meeting, which we anticipate will be in the September timeframe. And then probably is another 90 days before the...
September timeframe and then probably is another 90 days before they.
give a response to the request for the I&D. The clinical trials would begin in 2023, assuming that we are granted the I&D.
To give a response to their requests for the R&D clinical trials to begin in 2023, assuming that we are granted.
Randy.
Okay. Thank you very much.
Thank you, ladies and gentlemen, I'll now hand back over to Jay for any closing remarks.
you ladies and gentlemen, I'll now hand back over to Jay for any closing ones.
Thank you, operator, and thank you all for joining the call today. We're very happy with our progress so far, and we look forward to keeping everyone informed of our progress along the way. Thanks again for joining the call today, and have a great evening.
Thank you operator, and thank you all for joining the call today.
Happy with our progress so far and we look forward to keeping everyone informed of our progress along the way. Thanks again for joining the call today and have a great evening.
Thank you ladies and gentlemen, this does conclude today's conference call. You may now disconnect your phone lines and have a wonderful day. Thank you for your participation.
may now disconnect your phone line and have a wonderful day. Thank you for your