Q4 2021 Vyant Bio Inc Earnings Call
Okay.
Good morning and welcome to the ViandBio year end 2021 results conference call and webcast. Today, March 30, 2022, the company issued a press release summarizing results for the year end 2021 and filed its Form 10-K .
Good morning, and welcome to the <unk> bio year end 2021 results conference call and webcast today March 30th 2022, the company issued a press release summarizing results for the year end 2021 and filed its Form 10-K today's discussion we will provide an overview.
Today's discussion will provide an overview of activities in the fourth quarter and full year 2021 is being recorded and a replay of the webcast will be available on the Viant Bio website following today's call. Alternatively, the link can be sent to you by contacting IR at viantbio.com.
You have activities in the fourth quarter and full year 2021 is being recorded and a replay of the webcast will be available on the <unk> bio website following today's call.
Alternatively, the link can be sent to you by contacting I R at Fiat to bio 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.
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 ViantBio. Please go ahead.
At this time I would now like to turn the conference over to Jay Roberts, Chief Executive Officer of Bio Bio. Please go ahead Sir.
Thank you operator, and thank you all for joining the buying bio Investor Conference call and webcast for the year ended December 31 2021.
Jay Roberts: Thank you, Operator, and thank you all for joining the Buy and Buy Investor Conference call and webcast so that you're ended December 31, 2021.
What would it be fair to file our SEC reports and our press release sooner.
Jay Roberts: Well, we had planned to file our SEC reports and our press release sooner.
Jay Roberts: The SCC system was experiencing a global connectivity issue for a short period of time, so I apologize, but that's a delay.
Yes.
It was experiencing global connectivity issue for a short period of time, we apologize, but that's the way.
Now that the merger and the related integration activities are substantially complete.
Jay Roberts: Now that the merger and the related integration activities are substantially complete, we spent the fourth quarter fully focused on executing our business plan. It was also a great pleasure to speak with you today to share our enthusiasm and to give you some insight into how we envision the near-term future of Buy & Buy Online.
We spent the fourth quarter fully focused on executing our business plan.
It was also a great pleasure to speak with you today to share our enthusiasm and to give you some insight into how we envision the near term future of buying vital.
Jay Roberts: Additionally, we're going to present financial results for the year ended 2021. On the call with me today is Buy and Bios Chief Financial Officer Angela Frenz and our Chief Science Officer, Dr. Robert Primo.
Additionally, we're going to present financial results for the defendant.
2021.
The call with me today is <unk> Chief Financial Officer.
France, and our Chief Science Officer, Dr. Robert promote.
Following the Safe Harbor statement Doctor for a moment I will provide a strategic overview and update on recent scientific and corporate developments and division head many other people.
Jay Roberts: Following the Safe Harbor Statement, Dr. Fermo and I will provide a strategic overview and update on recent scientific and corporate developments and the vision ahead. Then Andy will take us through a brief financial update and discuss key accounting matters for the 2021 periods just ended. I will make some closing remarks, and then we will open up the lines for questions for Andy, Bob, and me. And we'll now turn the call over to our CFO , Andy LaFrance.
Take us through a brief financial update.
Key accounting matters for the 2021 periods just ended.
I will make some closing remarks, and then we'll open up the lines for questions for Andy Bob and me.
Turn the call over to our CFO , Andy what brands.
Okay.
Andy: Thank you, Jay. And welcome to all. We would like to remind everyone that various comments about future expectations, plans, and prospects constitute forward-looking statements.
Thank you Jay and walk them through all we would like to remind everyone that various comments about future expectations plans and prospects constitute forward looking statements for purposes of Safe Harbor provisions under the private Securities Litigation Reform Act of 1995 right.
Andy: for purposes of safe harbor provisions under the private securities litigation reform act of 1995.
Andy: Vine biocautions that these forward-looking statements are subject to risk and uncertainties that may cause our actual results to differ materially from those indicated, including risks described in the company's filings with the Securities and Exchange Commission.
<unk> 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 risks described in the company's filings with the Securities and Exchange Commission.
Speaker Change: Any forward-looking statements made on this conference call speak only of today's date, Wednesday, March 30, 2022, and VyantBio does not intend 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 rebroadcast on VyantBio's website at www.vyantbio.com. With that, I'd like to turn the call back over to Jay Roberts. Jay?
Any forward looking statements made on this conference call speak only as of today's date Wednesday March 32020 to invite buyout does not 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> website at Www Dot volume bio Dot com.
With that I'd like to turn the call back over to Jay Roberts Jay.
Thank you Randy.
As we begin the call today I think it is important to remind everyone that the fourth quarter was a third full quarter. Our company has operated as <unk>.
Jay Roberts: As we begin the call today, I think it's important to remind everyone that the fourth quarter was the third full quarter our company has operated as Bio and Bio. And today marks the one year anniversary of the merger.
Today marks the one year anniversary of the merger.
Jay Roberts: Today we will highlight the progress and accomplishments we have made over the past year.
We will highlight the progress and accomplishments we have made over the past year.
We have narrowed our focus to position <unk> as an emerging global drug discovery company pursuing a discovery and development of repurpose and novel Therapeutics to treat neurodevelopmental and neurodegenerative diseases, such as Red syndrome.
Jay Roberts: We have narrowed our focus to position Bio as an emerging global drug discovery company pursuing a discovery and development of repurpose and novel therapeutics to treat neurodevelopmental and neurodegenerative diseases such as red syndrome, CDKL5 deficiency disorder, or CDB and Parkinson's disease.
<unk> deficiency disorder or CBD in Parkinson's disease.
Jay Roberts: We believe there are significant value transition drivers in the drug discovery sector and we intend to use our unique approach to drive costs
We believe there is significant value creation drivers.
Discovery sector, and we intend to use our unique approach to drive cost.
Jay Roberts: savings, speed, and insightful decision-making to identify unique biological targets and novel therapeutics to treat patients with these debilitating diseases.
Savings speed and insightful decision, making to identify unique biological targets and novel therapeutics to treat patients with these debilitating diseases.
Jay Roberts: We have made promising progress, which we will highlight for you today.
We have made progress we have made promising progress, which we will highlight for you today.
And you can see on this slide we have four key discovery programs underway, which doctor for Bo will elaborate on in a few minutes.
Jay Roberts: As you can see on this slide, we have four key discovery programs underway, which Dr. Fremont will elaborate on in a few minutes.
DR feront: We enter 2020-22 focused on bringing a repurposed drug candidate, BYNT-0126, into clinical trials in the first half of next year.
We enter 2000, and 2022 focused on bringing a repurpose drug candidate B Y N T 0126 in two clinical trials in the first half of next year.
DR feront: We plan to provide you with more data and identification of our elite clinical compounds soon, once we finalize our IP efforts in the middle part of this year.
We plan to provide you with more data and the identification of our lead clinical compound soon once we finalize our IP efforts in the middle part of this year.
Our first two novel drug candidates, which supports two rare diseases, we noted.
DR feront: Our first two novel drug candidates, which support the two rare diseases we noted, are in the lead identification phase of discovery with our R&D team.
The lead identification phase III R&D teams.
DR feront: We have more work to complete on compound selection, the 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 for interrogating the biology through our own proprietary machine learning.
We have more work to complete the compound selection.
Iterative process, including high throughput screening and our <unk> micro brain for them.
The application of AI technologies on the chemistry.
Being done by our partners as well as our own analytics for interrogating the biology through our own proprietary machine learning system.
We are hoping to report our lead candidates for these programs later this year as we move to the REIT optimization phase early in 2023.
DR feront: We are hoping to report our lead candidates for these programs late this year as we move into the lead optimization phase early in 2023.
I will now highlight.
DR feront: I will now highlight a few key non-financial accomplishments from last year and actions as we are now wrapping up our first quarter of 2022.
A few key nonfinancial accomplishments for last year and actions as we have now wrapping up our first quarter of 2022.
First we strengthened our management team with the addition of an accomplished drug discovery.
DR feront: First, we strengthened our management team with the addition of an accomplished drug discoverer. One of our key hires last year had been the hiring of Dr. Bob Fromeau, who joined us in October 2021 to lead our drug discovery efforts, including lead target and candidate identification through IMD submission.
One of our key hires last year had been the hiring of Dr. Bob <unk>, who joined US in October 2021 to lead our drug discovery efforts, including target candidate identification.
Through our IND submissions.
DR feront: Dr. Fermot is already having a meaningful impact on our efforts in discovering novel therapeutics, which he was
Dr. <unk> is already having a meaningful impact on our efforts in discovering novel Therapeutics.
What you will share with you a few minutes.
DR feront: We have made a strategic decision earlier this year to further focus our business and our people on drug discovery and move away from providing products and services to others.
Okay.
<unk> decision earlier this year to further focus our business and our people on drug discovery and move away from providing products and services to others.
DR feront: In December of 2021, we engaged Collier's Securities in a
In December of 2021 engage Colorado's securities.
Yes.
DR feront: experience preclinical contract research organization services to assist us in the divestiture of our vivo farm preclinical services business.
Preclinical contract research organization services.
To assist us in the divestiture of our vivo form preclinical services business.
We recognize the vivo form is a well run operation with a skilled scientific staff.
DR feront: We recognize that vivofarm is a well-run operation with a skilled scientific staff. Our exit from the preclinical CRO services business will allow us to put our human and capital resources on our R&D efforts to discover and develop therapeutic assets for CMS diseases.
Or exit from the preclinical CRO services business will allow us to put our human and capital resources on our R&D efforts to discover and develop therapeutic assets for CNS diseases.
DR feront: The intended result of this transaction will be incremental, non-dilutive cash that provides fuel for our business.
The intended result of this transaction will be incremental non dilutive cash it provides fuel for our business.
DR feront: We're hoping to have this transaction completed in the first half of 2022.
We are hoping to have this transaction completed in the first half of 2022.
Further as we noted at our September 32020 Form 10-Q filing.
DR feront: Further, as we noted in our September 30th, 2021 forms and PEW filing, we began replicating certain R&D activities from our La Jolla, California location to our Maple Grove, Minnesota facility. As a result of the shift and our overall focus on CNS assets, we plan to see substantially all broad-based external product and discovery as a service revenue generation activities in the first half of 2022.
We begin replicating certain R&D activities for Barbara.
California location to our Maple Grove, Minnesota facility as.
As a result of the shift in our overall focus on CNS.
Assets, we plan to see substantially all broad based external product and discovery as a service revenue generation activities in the first half of 2022.
DR feront: In light of these changes, substantially all our Maple Grove staff will be focused on an internal CNS drug discovery pipeline.
In light of these changes substantially all remote Maple Grove staff will be focused on an internal CNS drug discovery pipeline.
DR feront: Third, yesterday 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 regulate Parkinson's disease pathology.
Third.
Yesterday, we announced an important collaboration agreement, which we entered into the promising company and scientific teams from <unk> therapeutics to develop a proprietary patient specific organoid.
Situate Parkinson's disease pathology.
DR feront: We believe this collaboration will accelerate our ability to discover small-molecule therapeutics to treat patients with Parkinson's disease.
We believe this collaboration will accelerate our ability to discover.
Mall molecule therapeutics to treat patients with Parkinson's disease.
DR feront: The collaboration brings together the respective team's expertise in drug discovery using 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 rescued the Parkinson's disease phenotype through the development of disease-linked
The collaboration brings together the respective teams expertise in drug discovery using 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 to the development of diseases linked clinically translatable assays and biomarkers through multiple molecular biochemical and cellular methods at applying machine learning techniques to yield unbiased result.
DR feront: Clinically translatable assays and biomarkers through multiple molecular, biochemical, and cellular methods, and applying machine learning techniques to yield unbiased results.
<unk>.
DR feront: We know that therapies for diseases that affect CNS are difficult to discover. It 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 in drug discovery through the use of technologies that allow insight into human biology early in the discovery of CNS drugs.
We know that therapies for diseases that affect the CNS are difficult to discover requires innovation and exceptional scientific expertise to tackle.
Collaborations like the few others, we have entered.
Is it.
Another in a series of strategic moves to focus our efforts, while accelerating our position in drug discovery through the use of technologies.
Insight into human biology early in the discovery of CNS drugs.
I'll now turn.
Speaker Change: I will now turn the call over to our Chief Scientific Officer, Bob Fermo.
I'll turn the call over to our Chief Scientific Officer, Bob for months Bob.
Thank you Jay I am thrilled to have the opportunity to discuss the buying by our pipeline.
Bob: Thank you, Jay, I'm thrilled to have the opportunity to discuss the BioPipeline.
Bob: At Viant Bio, 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 clinic.
I'd find bio 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.
Most drugs fail in the clinic due to lack of efficacy this was especially challenging for CNS drug development, where the available animal models have poor predictor value. Our approach is designed to allow us to identify therapeutic candidates that are active in the human disease setting at the earliest stages of our program potentially bypassing the need for animal models.
Bob: This is especially challenging for CNS drug development where 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 of efficacy.
Of efficacy.
Bob: 2021 was a year when we focused on defining our strategic vision for ViantBio and establishing and validating our human-first drug discovery platform.
2021 was a year when they focus on defining our strategic vision for <unk> bio and establishing a validating our human first.
RV platform.
We chose to initially focus on applying the transformative potential of our platform to develop precision medicines for patients suffering from rare CNS genetic disorders, including Ret syndrome City, Cal Fire's deficiency disorder, and familial Parkinson's disease.
Bob: We chose to initially focus on applying the transformative potential of our platform to develop precision medicines for patients suffering from rare CNS genetic disorders, including Rett syndrome, CTKL5 deficiency disorder, and familial Parkinson's disease.
Bob: Our scientific team has pioneered the development of organoid models of human brain disease from patients derived induced pluripotent stem cells that are sufficiently robust and reproducible to be amenable to high throughput screening. We're using this approach to identify both repurposed as well as novel small molecule therapeutic candidate.
Our scientific team has pioneered the development of Organoid models of human brain disease from patient derived induced pluripotent stem cells that are <unk>.
Sufficiently robust and reproducible to be amenable to high throughput screening we are using this approach to identify both repurposed as well as novel small molecule therapeutic candidates.
Bob: The key element of our strategy is the identification of relevant drug targets based upon 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 advances.
A key element of our strategy is the identification of relevant drug targets based upon 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 the desktop.
As we established our CNS drug discovery platform, we knew that we needed to employ the most innovative technologies to accelerate our drug discovery efforts and establish a competitive advantage to.
Bob: As we established our CNS drug discovery platform, we knew that we needed to employ the most innovative technologies to accelerate our drug discovery efforts and establish our competitive advantage.
Bob: To this end, we established a proprietary technology platform, Analytics, that is purpose-built for the processing, aggregation, and storage of large data files containing digital images of biological activity, primarily derived from our organoids, for use in our downstream data analysis and machine learning models.
To this end, we establish a proprietary technology platform analytics that is purpose built for the processing aggregation and storage of large data files containing digital images.
Lots of activity.
Primarily drives from our Organoid for use in our downstream data analysis and machine learning models.
Bob: Our data science team has developed an efficient process to translate drug experiment designs from the lab into machine-readable formats to process large data sets sourced directly from laboratory equipment and to 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 for adverse events.
Our data science team has developed an efficient process to translate drug experiment designs from the lab into machine readable formats to process large datasets sourced directly from laboratory equipment and to extract unbiased quantified documentations are biologically relevant features to enable the characterization of disease states the profile.
<unk> of treatment effects in the assessment of possible toxicity for adverse events.
We further pursue key collaborations with companies that employ artificial intelligence and machine learning based therapeutic creation of prediction in three areas novel small molecule design proteome based target identification and novel Biologics protein design, all three arrangements have meaningfully accelerated our focus.
Bob: We further pursued key collaborations with companies that employ artificial intelligence and machine learning-based therapeutic creation and prediction in three areas, novel small molecule design, proteome-based target identification, and novel biologics protein design. All three arrangements have meaningfully accelerated our focused CMS therapeutic discovery efforts.
CNS therapeutic discovery efforts.
Okay.
Bob: RET syndrome is a rare genetic neurological disorder that leads to severe impairments affecting nearly every aspect of the child's life, including their ability to speak, walk, eat, and even breathe easily. The hallmark of RET is near constant
Ret syndrome is a rare genetic neurological disorder.
Leads to severe impairments affecting nearly every aspect of a child's life, including their ability to speak.
Walk eat and even breathe easily.
A hallmark of <unk> is near constant repetitive hamburgers.
Bob: Red is usually recognized in children between 6 to 18 months as they begin to miss developmental milestones or lose abilities they had gained. Red is caused by mutations on the X chromosome in a gene called MECP2.
Red is usually recognized in children between six to 18 months as they begin to Mr developmental milestones or lose abilities ahead game ready.
<unk> is caused by mutations on the X chromosome in a gene called <unk>.
Bob: Our RET patient brain organoids exhibit a consistent and robust disease-specific functional phenotypic signature that is markedly different from that of healthy controlled organoids and can be measured in a high throughput fashion using kinetic imaging systems such as slipper.
Our vent patient Green Horrigan always exhibited a consistent and robust disease specific functional synthetic signature that is markedly different from that of healthy control organoid and can be measured in the highest throughput fashion using kinetic imaging systems such as slippery.
Bob: We currently have two ongoing and promising programs focused on RET, a repurposing candidate.
We currently have two ongoing and promising programs focused on that.
Repurposing candidate.
Bob: Viant 0126 and several novel compounds that were identified based on a syncypic screen of the smart library provided by the International RET Student Foundation on our RET patients-derived organoids.
<unk> Oh, one through six and several novel compounds that were identified based on Afinitor epic screen of the Smart library provided by the International Retsina Foundation on our Rep patient derived organized.
V Y N T zero, one through six molecule is a promising we purposely candidate for several reasons.
Bob: The VYNT0126 molecule is a promising repurposing candidate for several reasons.
The compound has already been approved by the FDA as a condition has some medication for dementia related to Alzheimer's disease, and there are readily available safety data.
Bob: The compound has already been approved by the FDA as a condition enhancement medication for dementia related to Alzheimer's disease and there are readily available safety.
W. I N. Two O one through six exhibits that consistent dose dependent rescue of several retinal disease phenotypes and our reputation thrive organize we intend to file an IND application for our new purpose candidate in Q1 of 2022 and to request orphan drug designation.
Bob: DYN-201-26 exhibits a consistent, dose-dependent rescue of several RET disease phenotypes in our RET patient-thrived organoids. We intend to file an IND application for our RET repurposing candidate in Q1 of 2022 and to request orphan drug designation.
Bob: We are meeting with the International Rest Syndrome Foundation Clinical Trial Committee in mid-April to prepare for a pre-ID meeting with the FDA.
We are meeting, but the international rest syndrome Foundation clinical trial Committee in mid April to prepare for a pre IDE meeting with the FDA.
Bob: We are also pursuing novel compounds for RET, directed against two additional targets in collaboration with our joint venture partner, Adam.
We are also pursuing novel compounds for ret directed against two additional targets in collaboration with our joint venture partner Adam Wise.
Bob: 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 the degree of phenocytic rescue in our organoid models. Respect to identify potential lead candidates in 2022 and commence enabling studies in the first half of 2023.
We are applying machine learning to drive comp progression and are establishing in vitro binding in cell based functional assays for these targets to examine the relationship between target potency and the degree of Felicific rescue and our Organoid models, we expect to identify potential lead candidates in 2022 and commenced IND, enabling studies.
In the first half of 2023.
Bob: We are excited by recent evidence we have obtained that both our repurposing candidate EYNT 0126 and our novel RET candidates act on distinct biochemical targets and exhibit a differentiated mechanism of action for the most clinically advanced RET therapeutic candidates.
We are excited about you said evidenced we obtain that both are Repurposing candidate <unk> T zero, one through six and our novel Ret candidates Act on distinct biochemical targets and exhibit a differentiated mechanism of action for the most clinically advanced ret therapeutic candidates.
Kidney care sides deficiency disorder is a neurodevelopmental condition characterized by early onset epileptic seizures intellectual delay and motor dysfunction.
Bob: TDKL5's Efficiency Disorder is a neurodevelopmental condition characterized by early onset epileptic seizures, intellectual delay, and motor dysfunction.
Although crucial for proper brain development, the precise targets of <unk> five and its pathophysiological link to patient symptoms are currently not understood.
Bob: Although crucial for proper brain development, the precise targets of CBKL5 and its pathophysiological link to patient symptoms are currently not understood.
Bob: While genetic testing is currently available to identify patients that have a mutation in the CDKL5 gene, limited knowledge of the underlying process physiology has hindered the identification of potential therapeutic targets and the discovery of drug cancer.
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.
<unk> is an ultra rare muscle disease with a defined unmet medical need with only one recently approved therapeutic treatment.
Bob: CDD is an ultra rare neurodevelopmental disease with a defined unmet medical need with only one recently approved therapeutic treatment.
Bob: We screen the custom library of approximately 5,200 molecules composed of FDA approved drugs, molecules that passed phase one clinical trials, and a panel of phenotypic screening compounds with the goal to identify both novel molecules and potential repurposing candidates.
We screen the custom library of approximately 5200 molecules composed of FDA approved drugs molecules that past phase one clinical trials and a panel of phenotypic screening compounds with the goal to identify both novel molecules and potential repurposing candidates.
Bob: Approximately 288 compounds show some degree of rescue of the CDD phenotype, hyper-excitability phenotype in our organized models. We are conducting further confirmatory screening followed by those response studies and pharmacologic deconvolution to identify promising lead scalps.
Approximately 280 compounds show some degree of rescue of the CVD phenotype hyperexcitability phenotype.
And our Organoid models.
We are conducting further confirmatory screening followed by dose response studies and pharmacologically convolution to identify promising lead scaffolds. In addition in collaboration with cyclical we are applying a machine learning approach utilizing and silica screening to identify novel candidate molecules for three potential CBD.
Bob: In addition, in collaboration with CYCLICA, we are applying a machine learning approach utilizing and silico screening to identify novel candidate molecules for three potential CDD targets that we will screen in our CDD organoids. We expect to identify potential lead candidates towards the end of 2022 and commence IMB enabling studies in the first half of 2023.
Targets that will that we will screen in our CBD organized we expect to identify potential lead candidates towards the end of 'twenty, two and commence R&D, enabling studies in the first half of 2023.
Parkinson's disease is a progressive neurodegenerative disorder that affects phenomenally dopamine producing neurons in a specific area of the brain called the substantial Niagara.
Bob: Parkinson's disease is a progressive neurogenic disorder that affects predominantly dopamine-producing neurons in a specific area of the brain called the substantia nigra.
Bob: Parkinson's disease symptoms generally develop slowly over the years and include tremors, muscle rigidity, gait and balance problems, and slow, imprecise movement.
Parkinson's disease symptoms generally develop slowly over the years and include tremors muscle rigidity gait and balance problems and slow imprecise movements.
Bob: The etiology of Parkinson's disease is poorly understood, but it is widely accepted that a combination of genetics and environmental factors are the cause.
The etiology of Parkinson's disease is poorly understood, but it is widely accepted that the combination of genetics and environmental factors are the cost.
Bob: About 10 to 15% of people with Parkinson's disease have a family history of the condition, and indeed, family-linked cases can result from genetic mutations in a handful of genes, including the glucose reubicidase gene, GBA, and LRRK2, among others.
About 10% to 15% of people with Parkinson's disease have a family history of the condition and indeed family link cases can resolve some genetic mutations and a handful of genes, including the glucose beside X gene GBA embark to L. R. R. K two among others.
As Jay mentioned on March 29th 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.
Bob: As Jay mentioned, on March 29th, we announced a collaboration with Organotherapeutics to advance our work on the identification of lead compounds that are expected to be disease-modifying in Parkinson's disease. Organotherapeutics has developed several proprietary familial Parkinson's disease patient-specific organoids that recapitulate Parkinson's disease pathology.
Gas oriented therapeutics has developed several proprietary familial Parkinson's disease patient specific organize that recapitulate parkinson disease pathology.
The collaboration brings together the respective teams expertise in drug discovery using human drive cells high.
Bob: The collaboration brings together the respective teams' expertise in drug discovery using human-derived cells.
Bob: high throughput biology and chemistry, and machine learning-based therapeutic design to gain insights in the patient-specific responses to potential Parkinson's disease drugs.
High throughput biology, and chemistry and machine learning based therapeutic design to gain insights into patient specific responses to the central Parkinson's disease drugs.
Scientists from both sites, we utilized complex patient derived <unk> organoid models created from induced pluripotent stem cells to identify disease linked clinically translatable assays of biomarkers through multiple molecular biochemical and cellular approaches to identify drug candidates that rescue the PD phenotype.
Bob: Scientists from both sites will utilize complex patient-derived 3D organoid models created from induced pluripotent stem cells to identify disease-linked, clinically translatable assays and biomarkers through multiple molecular, biochemical, and cellular approaches to identify drug candidates that rescue the PD phenotype.
Bob: Our initial focus will be on the GBA and LRK2 familial mutations.
Our initial focus will beyond the GBA MLR K too familiar mutations.
By focusing initially on these familiar Parkinson's disease linked mutations, we expect to identify common causes and potential therapeutic approaches.
Bob: By focusing initially on these familial Parkinson's disease linked mutations, we expect to identify common causes and potential therapeutic approaches that can be expanded into the much larger sporadic patient population.
It can be expanded into the much larger sporadic patient population.
I will now turn the call over to Andrew the France, Our Chief Financial Officer to discuss financial results for the year end 2021, Andy.
Bob: I will now turn the call over to Andy LaFrance, our Chief Financial Officer, to discuss financial results for the year-end 2021. Andy?
Andy.
Thank you Bob.
Andrela France: Hello, everyone, and thank you again for joining our call. Today, we'll review our cash position as of December 31st, 2021, and our financial results for 2021.
Hello, everyone and thank you again for joining our call today I will review our cash position as of December 31, 2021, and our financial results for 2021.
Andrela France: First and foremost, we ended the year with $20.6 million in cash. We supplemented our liquidity with Monday signing of a $10 million, $15 million.
First and foremost we ended the year with $26 million in cash we supplemented our liquidity with Monday signing.
$10 million $15 million.
Andrela France: equity line of credit with Lincoln Park. We believe that this equity line of credit coupled with our cash balances and estimated proceeds from the sales of Vivo Farm Business will provide this cash runway into mid-2023.
Equity line with Lincoln.
In part we believe that this equity line of credit coupled with our cash balances and estimated proceeds from the sale of the vivo farm business will provide us cash runway into mid 2023.
Andrela France: Before I review the 2021 Statements of Operation data, a little background information will help explain results. As you will recall, Stemonics, Inc. was deemed to have acquired Cancer Genetics for accounting purposes.
Before I review the 2021 statements of operation data, a little background information will help.
Helane results as you will recall the monarch shrink was deemed who have acquired cancer genetics for accounting purposes, and the merger closed a year ago.
Andrela France: And the merger closed a year ago, March 30, 2021.
32021.
Andrela France: This company's current year financial results include the cancer genetics operations since the merger date, and the 2020 financial results are based solely on the shenanigans operations.
The company's current year financial results include the cancer genetics operations since the merger date and the 2020 financial results are based solely on the Nymex operations.
Andrela France: As Jay noted in his remarks, during the fourth quarter of 2021, we commenced the process to sell the VivoFarm business.
As Jay noted in his remarks during the fourth quarter of 2021, we commenced the process to sell the vivo farm business.
Andrela France: As a result of this decision, we have classified the Beagle Farm business as a held for sale asset and its financial information as discontinuing operation.
As a result of this decision we have classified the vivo farm business as a held for sale asset and this financial information is discontinuing operations.
Andrela France: Therefore, continuing operations as of and for the year ended December 31st, 2021, consists of the Viant Bio and Schematics, Inc.
Therefore, continuing operations as for the year ended December 31, 2021 consists of the <unk> file and <unk>, Inc.
Andrela France: The reclassification of the Avivo farm business as health or sale required us to assess its fair value based on its estimated selling price as compared with its carrying value, which included the $22.4 million of goodwill arising from the March 30th, 2021 merger.
The reclassification of the vivo fiber business as held for sale required us to assess its fair value.
Just on the test.
Price as compared with its carrying value, which included the $22 $4 million of goodwill arising from the March 30, <unk> 2021 merger.
Andrela France: As a result of this analysis, we recorded a non-cash goodwill impairment charge of $20.2 million in the fourth quarter of 2021.
As a result of this analysis now says we recorded a noncash goodwill impairment charge of $22 million in the fourth quarter of 2020 to 21 excuse me.
Andrela France: Overall, the net loss of $8.7 million in 2020 increased to $40.9 million in 2021. The 2021 net loss included a total of $26 million of non-cash expenses, as well as $2.3 million of merger-related expenses.
Overall, the net loss of $8 $7 million in 2020 increased to $40 9 million in 2021. The 2021 net loss included a total of $26 million of noncash expenses as well as $2 $3 million of merger related expenses.
The net loss from continuing operations aggregated $18 $6 million and included noncash expenses of $4 $8 million as well as $2 3 million.
Andrela France: The net loss from continuing operations aggregated $18.6 million and included non-cash expenses of $4.8 million as well as $2.3 million of merger-related costs. The net loss of $22.3 million from discontinuing operations included the $20.2 million goodwill impairment charge and non-cash expenses of approximately $1 million.
Of merger related costs, and net loss of $22 3 million from discontinued operations included the $22 million goodwill impairment charge and noncash expenses of approximately $1 million.
Revenues from continuing operations for 2021 one.
Andrela France: Revenue from continuing operations for 2021 was $1.1 million as compared with $867,000 in 2020. This revenue was derived from our Stemonics product and service revenue. As we previously reported, we plan to discontinue the Stemonics external revenue generation to focus on our resources on internal drug discovery efforts.
$1.1 million as compared with $867000 in 2020.
This revenue was derived from our <unk> product and service revenue as we previously reported we plan to discontinue the <unk> external revenue generation to focus on our resources uninterrupted.
Every efforts.
Andrela France: Cost of Goods Sold service aggregates $408,000 in 2021 and $384,000 in 2020, resulting in the cost of goods sold of 61.4% and 65.3% respectively.
Cost of goods sold service aggregates for an $8000 2021 and $384000 in 2020, resulting in the cost of goods sold of 61, 4% and 65, 3%, respectively cost controls product aggregated $1 4 million.
Andrela France: Cost of Goods Sold product aggregated $1.4 million and $717,000 for the years ended December 31st, 2021 and 2020, resulting in the Cost of Goods Sold margin deficit of $956,000 and $438,000 respectively.
$717000 for the year ended December 31, 2021, and 2020, resulting in our cost of goods sold margin deficit of $956000.
$438000 respectively.
Andrela France: The increase in the product cost of sales in 2021 were employee and other product-related costs.
The increase in the product cost of sales in 'twenty, 'twenty, one where employee and other product related costs.
Andrela France: As we move our Maple Grove Facility to Internal Development Activities in 2022, the costs for this facility will have a course-binding shift to research and development costs in 2020.
As we move our Maple Grove facility to internal development activities in 2022, the cost of this facility will have a corresponding shift to research and development costs in 2022.
Andrela France: Research and Development Class of 2021 increased to $4.3 million as compared with $3.2 million in 2020 and was a result of increased headcount lab and professional service costs.
Research and development costs for 2021 increased to $4 $3 million as compared with $3 $2 million in 2020 and was a result of increased headcount lab and professional service costs.
Selling general and administrative expenses increased from $2 $7 million in 2020 to $8 $4 million in 2021. This increase was largely related to post merger.
Andrela France: selling general and administrative expenses increased from $2.7 million in 2020 to $8.4 million in 2021. This increase was largely related to post-merger public costs, including headcount, stock lease compensation, professional fees, and insurance costs.
Public costs, including head count stock based compensation professional fees and insurance costs.
Speaker Change: I will close for now and hand the presentation back over to Jay Roberts for closing remarks. Jay?
I will close for now and hand, the presentation back over to Jay Roberts for closing remarks Jay.
Jay Roberts: Thank you, Andy. As we come to the final part of today's call, I would 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, that our activities in the fourth quarter and year-end 2021 focused purely on establishing buy-in buyouts, foothold in the industry.
Thank you Randy.
As we come to the final part of today's call I would 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 that our activities in the fourth quarter and year end 2021 focused purely on establishing <unk> foothold in the industry.
And helping to fuel our activities into the first quarter of 2022 and beyond please.
Jay Roberts: in helping to fuel our activities into the first quarter of 2022 and beyond.
Jay Roberts: Please stay tuned as we continue to make progress. We also invite new listeners to become more familiar with ViantBio. As news and information becomes available, we will be communicating updates via press releases, LinkedIn, the new ViantBio website, and other social media outlets.
Please stay tuned as we continue to make progress we also invite new listeners to become more familiar with <unk>.
As news and information becomes available we will be communicating updates.
Yes releases linked in the new body by a website and other social media outlets.
Speaker Change: Interested parties are invited to sign up for the press release 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.
Interested parties are invited to sign up to the press release 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.
Operator.
Bob: Thank you. Ladies and gentlemen, the floor is now open for questions.
Thank you ladies and gentlemen, the floor is now open for questions. If you have any questions or comments. Please press star one on your phone now to join the queue. If you wish to withdraw from the queue. You May Press Star Q, We do ask that if you are listening via speakerphone. Please pick up your handset for optimum sound.
Bob: If you have any questions or comments, please press star 1 on your phone now to join.
Bob: If you wish to withdraw from the queue, you may press start.
Bob: We do ask that if you are listening by a speakerphone, please pick up your handset for optimum sound quality. Once again, if you have any questions or comments, please press star 1 now.
Quality once again, if you have any questions or comments. Please press star one now.
Speaker Change: Our first question today is coming from Ed White at H.C. Wainwright. Your line is live. You may begin.
Our first question today is coming from Ed White at H C. Wainwright. Your line is live you may begin.
Good morning, Jay Andy and Bob Thanks for taking my questions.
Ed White: Morning, Jay, Andy and Bob. Thanks for taking my question.
Ed White: So the first question is about the divestiture of DecoFarm.
So the first question is about the divestiture of vivo form.
Have you had any interest yet.
Ed White: have you had any interest yet? And can you give us our thoughts maybe on the value of that divestiture? And then, Andy, how should we be thinking of revenue from continuing operations with the divestiture?
And can you give us our thoughts maybe on the value.
All that.
Divestiture.
Then Andy how should we be thinking of revenue from continuing operations.
With the divestiture.
For 2022, so let me yes.
Ed White: for 2022. So let me, yeah, so let me just start and then Andy can fill in the blanks here. So just in terms of the level of interest, Collier's securities.
So let me just start and then Andy can.
<unk> put into place here, so I guess in terms of the level of interest colliers.
<unk>.
Ed White: started marketing the opportunity several weeks ago. And so far the interest level we think is pretty high.
Started marketing.
The opportunity several weeks ago.
So far the interest level, we think is pretty high so we're quite optimistic about what we've seen so far.
Ed White: So we're quite optimistic about what we've seen so far. And you know, they've done a really good job for us. And as we've moved through, you know, what is a very well-defined process and we're anticipating it will stay on our scale.
They've done a really good job for us.
Move through.
Very well defined process and we're anticipating that we will stay on our schedule are pretty close to it.
Ed White: That being said, in terms of valuation, I think it may be the best way to think about it is.
Being said in terms of valuation I think maybe the best way to think about it is the work that we did relative to the accounting for it.
Ed White: the work that we did relative to the accounting for it.
Andrew that's perhaps something that you can just address real quickly if you could.
Speaker Change: Thank you, Jay, and what I would say about the evaluation in terms of the
Yes, Thank you Jay.
And what I would say about.
The valuation in terms of that.
Speaker Change: in terms of our specific cash flow is that, you know, we're very fortunate to have a number of market comps out there, not only in terms of transaction sets, as well as, you know, potential acquires of the company and given those revenue multiples, you would expect to see a business like this to sell for anywhere between one to two plus times revenue.
In terms of our cash.
Cash flow is that.
We're very fortunate to have a number a number of market comps out there not only in terms of transaction sets as well.
Potential acquirers of the company and given those revenue multiples you would expect to see a business like this to sell for.
Between one to two plus.
Tightens revenues and so as we think about.
Speaker Change: And so as we think about, you know, valuing the company, we use those sorts of parameters.
Valuing the company, we use those sorts of parameters to get our arms around that and Theres a number of different pieces that to that that our relative one is obviously historical revenues, but we also think that that business, which is very well Brian is a very good.
Speaker Change: To to get our arms around that and there's a number of different pieces that to that that are relative one is also historical revenues
Speaker Change: But we also think that that business, which is very well run, is on a very good new growth trajectory.
Revenue growth trajectory.
Speaker Change: given what we see going on in terms of it's signed and back on contract. So, you know, right now we've got, and this is all within our 10K filing, you know, we've got it valued, you know, somewhere, you know, north of $10 million.
Given what we see going on in terms of itself.
Signed and backlog contracts. So right now we've got and this is all within our 10-K filing.
We've got valued.
Somewhere in there.
North of $10 million.
Speaker Change: And our expectations are that, you know, we would continue to go through a very robust process here. And we're looking forward to seeing some bids here in the near term.
And our expectations are that we would.
Continue to go through a very robust process here and were looking forward to seeing some bids here in the near term.
Speaker Change: The second piece of your question there was in terms of continuing operations revenue generation.
The second piece of your question there in terms of continuing operations revenue generation, and we really expect that to be less than half a million dollars in 2022.
Speaker Change: And we really expect that to be less than half a million dollars in 2022. We really are very quickly winding that down. And I think Bob is very pleased with our focus and getting our team in Maple Grove and working with our team in La Jolla to accelerate our drug discovery progression. So that should be our expectation for 2022 revenue.
We really are very quickly winding that down and I think Bob is very pleased with our focus and getting our team in Maple Grove.
Working.
With our team a little hoya to accelerate our drug discovery.
Progression, so that should be your expectation for 2022 revenues.
Yes.
Okay. Thanks, Andy.
Speaker Change: Okay, thanks, Andy. And then, you know, Bob.
And then Bob actually he was speaking very quickly so I wanted to make sure I didn't miss anything here.
Speaker Change: speaking very quickly, so I want to make sure I didn't miss anything here. But on VYNT 0126, the repurposed drugs.
But on a V I N T.
Tier one to fix the repurpose drug.
Speaker Change: Um, can you just go over the timeline again as far as, uh,
Can you just go over the timeline again as far as.
Speaker Change: the timing to the INV filing and how far you're going to bring the drug before looking to partner?
The timing to the IND filing and how far youre going to bring the drug before looking to partner it.
Well why don't you picked up on up.
Speaker Change: Why don't you pick that one up and I'll fill in on the back side of the future.
Ill fill in on the backside of the.
Sort of the future.
Speaker Change: Sure. Thanks, Jay. So first, apologies, Ed, for talking too fast.
Sure. Thanks, Jay So first apologize Ed for talking too fast.
Speaker Change: I'm pretty excited, I'm sorry about that. We are meeting with the International Red Syndrome Foundation in middle April , the 16th or 17th, to meet with our Clinical Trial Committee to draft the plans for our setting of date for a pre-IND meeting with the FDA. We expect to request a pre-IND meeting in the May, June timeframe.
I'm sure they say Oh, sorry, sorry about that.
We are meeting with international Ret syndrome Foundation.
Middle April 16th or 17th to meet with our clinical trial Committee.
To draft the plans for <unk>.
Setting a date, where pre IMD meeting with them.
We expect to request a pre IND meeting in the May June timeframe and then two months later, we will have a meeting with those with the FDA. So we expect to have the.
Speaker Change: And then two months later, we would have our meeting with the FDA. So, we expect to have the actual IND meeting in the early to mid part of Q4. So, sometime in the September , October timeframe.
The actual meeting.
In the early to mid part of Q4, so sometime in the September .
October timeframe.
Speaker Change: first submitting the IMD and then with the timeline for approval, we hope to have the approval completed by the end of the year for the IMD approval.
Submitting the IND.
With them with the timeline for approval, we hope to have the approval completed by the end of the year.
The <unk> approval.
Speaker Change: And then let me just also address the second part of that question, which was how far do we have – we know we think we're going to bring it. And, you know, obviously being able to partner with parties that may have an interest in taking the drug all the way through to commercialization is our ideal pathway. We're prepared to take it as far as we need to to get to the right economics.
And then let me just still also address the second part of that question, which was how far do we have we think we're going to bring it in.
Obviously.
Being able to partner.
With parties that may have been interested in taking.
Taking the.
The drug all the way through to commercialization.
Our ideal pathway, we're prepared to take it as far as we can to get to the right economics.
Speaker Change: And we're in the very active process in terms of getting those kinds of relationships built as we speak today. And we'll see kind of the interest like, but we think that given the sort of the economic dynamics of drugs that are treating rare diseases that have a little to no, very high medical need, we think that there'll be a certain amount of interest. Thank you.
And we're in the very active.
Process in terms of getting those kinds of relationships built as we speak today.
We will see kind of the interest rate I would think that given.
So it's sort of the economic dynamics of.
The drugs that are treating rare diseases that have.
No.
Very high unmet.
Unmet medical need we think that there'll be an oracle.
A lot of interest.
Yeah.
Okay, great. Thanks, Bob.
Alright.
Jay We've got a couple of questions that have come up in the online chat room here and maybe I could get.
Speaker Change: Jay, we've got a couple questions that have come up in the online chat room here and maybe I could, as people maybe queue up for additional questions here, I could respond to those. One of the questions that came up was related to our cash burn. In our stated remarks here, you know, the combination of cash on hand of $20.6 million
As people, maybe cure for additional questions sure I could respond to those one of the questions that came up was related to cash burn.
In our stated remarks sure the.
The combination of cash on hand of $26 million plus the Lincoln Park.
Speaker Change: equity line of credit and proceeds from the vehicle firing business, and we expect that we've got cash into at least mid-2023 at this point in time.
Equity line of credit and proceeds from the vehicle finance business, we expect that we've got the cash into into at least mid 2023 at this point in time and.
Speaker Change: And, you know, that also, at this point in time, as we talk about cash flow, does not look at a licensing transaction at this point in time. But as Jay and Bob just articulated, you know, we're getting to a point where we can start to have, you know, these candidates into a clinical setting where they're going to be licensable. So, I think that answers a couple of questions that are currently in the chat.
That also.
This point in time as we've talked about cash flow it does not.
Look at a licensing transaction at this point in time, but as Jay and Bob just articulated.
Getting to a point, where we can start to have.
You know these candidates into a clinical setting whether that'd be a licensed ball so.
I think the answer is a couple of questions that are currently in the chat room.
Speaker Change: Okay. Operator, I don't believe that there's no other questions. I'd just like to be able to thank everybody 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, and have a great day.
Okay, operator, I don't believe that there is no other questions I'd, just like to be able to thank everybody for joining the call today.
We're very happy with our progress so far.
We look forward to keeping everyone informed of our progress along the way. Thanks again for joining the call and have a great day.
Thank you ladies and gentlemen, this does conclude todays event you may disconnect at this time and have a wonderful day, we thank you for your participation.
Speaker Change: Thank you ladies and gentlemen, this does conclude today's event. You may disconnect at this time and have a wonderful day. We thank you for your participation.