Q3 2023 Biora Therapeutics Inc Earnings Call
Speaker 1: Greetings and welcome to the Bioware Therapeutics 3rd Quarter 2023 Earnings Call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone.
Greetings and welcome to the <unk> Therapeutics third quarter 2023 earnings call. At this time, all participants are in a listen only mode.
A question and answer session will follow the formal presentation. If anyone should require operator assistance. During the conference. Please press star zero on your telephone keypad as a reminder, this conference is being recorded.
Speaker 1: As a reminder, the conference is being recorded. It is now my pleasure to introduce your host, Chuck Padilla, Managing Director with Lifestyle Advisors. Thank you, Chuck.
It's now my pleasure to introduce your host Chuck put all a managing director with lifestyle advisors. Thank you Chuck you may begin.
Speaker 2: Thank you, Operator. Good afternoon and welcome to the Biora Therapeutics third quarter 2023 Corporate Update and Financial Results conference call. Joining me on the call are Adi Mahanty, Chief Executive Officer, Eric Visparvis, Chief Financial Officer.
Thank you operator.
And welcome to the bio Therapeutics third quarter 2023, corporate update and financial results Conference call.
What do you mean on the call our Alibaba hobby, Chief Executive Officer, Eric as far as Chief Financial Officer.
Speaker 2: Before I turn the call over to Mr. Behati, I would like to remind you that today's call will include forward-looking statements in the meaning of the federal securities laws, including, but not limited to, the types of statements identified as forward-looking in our quarterly reports, Form 10-Q , that we file or will file later today, and our subsequent reports filed with the SEC, which are available on our website, the Investor section.
Before I turn the call over to Mr. Mohanty I'd like to remind you that today's call going forward.
It isn't the meaning of the federal securities laws, including but not limited to the types of statements identified as forward looking in our quarterly report Form 10-Q that we filed our final we'll file later today and our subsequent reports filed with the SEC shares available on our website the investor sector.
Speaker 2: These forward-looking statements represent our views only as of the date of this call about financial risks and uncertainties, including many that are beyond our control.
These forward looking statements represent our views only as of the date of this call Bob actual risk and uncertainties.
Many that are beyond our control.
Speaker 2: Please note, the actual results could differ materially from those expressed in the forward loop mistake.
Please note that the actual results could differ materially from those expressed in the forward looking say.
Speaker 2: For a further description of the risks and uncertainties that could cause actual results to differ materially from those expressed in the form of statements, as well as risks related to our business, please see the company's period of reports filed with the SEC. With that, I will now turn the call over to Adi Mohanty, CEO of Biora Therapeutics. Adi? Thanks, Chuck. And thank you, everyone, for joining us. During the third quarter, we continued to make excellent progress with both of our platform
For a further description of the risks and uncertainties.
Cause actual result to differ materially from basic, especially before the big statement as long as the risks related to our business. Please see the company's period reports filed with the SEC with that I'll now turn the call over to Alibaba I already therapeutics hearty. Thanks, Chuck and thank you everyone for joining us here in the.
Third quarter, we continued to make excellent progress with both of our platform technology, but now the Jive platform is rapidly advancing towards initiation of a phase one clinical trial by year end and development of the Biogen platform has accelerated with an increased pace of data generation from several molecules, including those.
Speaker 2: The NaviCAP platform is rapidly advancing towards initiation of a phase one clinical trial by year end, and development of the BioJet platform has accelerated with an increased pace of data generation from several molecules, including those of our pharma collaborator.
Pharma collaborators first an update on our 90 cab targeted therapeutics platform with our lead program between 600 and ulcerative colitis.
Speaker 2: An update on our NaviCat targeted therapeutics platform with our lead program, BT600 and ulcerative colitis. We suggest there is a minimum level of drug needed in the tissue at the site of disease to achieve better therapeutic outcomes in ulcerative colitis or UC.
[laughter] suggests there is a minimum level of drug needed in the tissue.
The site of disease to achieve better therapeutic outcomes in ulcerative colitis, where you see ultra.
Speaker 2: Our technology can potentially increase tissue concentration without systemic toxicity, which could provide improved outcomes for UC patients. We hope to demonstrate this with a phase one clinical trial, which we are on track to initiate by end of this year.
Our technology can potentially increase tissue concentration without systemic toxicity, which could provide improved outcomes for UC patients. We hope to demonstrate this with a phase one clinical trial, which we are on track to initiate by end of this year.
Speaker 2: Earlier, we filed our IND application with the FDA as planned.
We filed our R&D application the P F P as planned.
Speaker 2: The IND for BT 600 includes extensive manufacturing, clinical and toxicology data, as well as clinical device function data from our four separate studies in both healthy volunteers and UC patients.
R&D for BT 600 includes extensive manufacturing preclinical and toxicology data as well as clinical device function data from our four separate studies in both healthy volunteers and UC patients.
Speaker 2: So, it's a sizable filing that includes over 300 documents, larger than a typical submission because we have both drug and device information. The FDA often generates questions and requests information as they review these types of filings. Towards the end of the FDA review period, we received some questions that required us to provide additional information, which we had.
So exercisable filing that includes over 300 documents larger than a typical submission because we have both drug and device information E. S. P. A often generates questions and requests information as they review these types of filing towards the end of the FDA review period.
We have some questions that required us to provide additional information, which we have.
Speaker 2: We discussed the questions of the agency, and as a result of our conversation, it became clear that it was appropriate for us to refile, which we did. This allows the FDA to have additional time to review our application and the additional information. We continue to have a constructive dialogue with the FDA, and it's understandable that the extensiveness of the information supporting our IND would require additional time for review, we hope the review will be satisfactorily completed by the end of this month.
We discuss the questions that the agency and as a result of our conversation.
I'm clear that it was appropriate for us to re file which we did this allows the F. D. A to have additional time to review our application and the additional information we continue to have a constructive dialogue with the FDA and it's.
Understandable that the expenses necessary information supporting our R&D would require additional time for review we hoped it would be it will be satisfactorily completed by the end of this month.
Speaker 2: If so, we anticipate maintaining our timeline to initiate a phase one trial before the end of this year.
So we anticipate maintaining our timeline to initiate a phase one trial before the end of this year.
Speaker 2: We are, to our knowledge, the first company to file an IND for a drug and ingestible device combination, while other companies have pursued clinical studies that's outside the U.S.
We are to our knowledge the first company to fall in R&D for a drug an ingestible device combination.
While other companies are pursuing clinical studies, that's outside the U S. We believe it's important to engage U S regulators as early as possible and to take the most rigorous paths to approval.
Speaker 2: We believe it's important to engage U.S. regulators as early as possible and to take the most rigorous path to approval.
Speaker 2: We've successfully completed four human studies in which the NaviCab device performed as designed across a range of expected differences in GI motility in both healthy volunteers and UC patients.
We have successfully completed for human studies, and which cannot be captive ice performed as designed across a range of expected differences in Gi motility in both healthy volunteers and UC patients.
The next step is to use another cab device to deliver tofacitinib.
Speaker 2: The next step is to use the NaviCab device to deliver to a facility.
Speaker 2: We aim to prove our treatment hypotheses by confirming that we can achieve sufficient drug levels in the colon tissue along with low systemic exposure.
We aim to prove our treatments hypotheses by confirming that we can achieve sufficient drug levels in the colon tissue along with low systemic exposure.
Speaker 2: We anticipate exiting phase one with not only safety data, but also with critical data on potential exposure in both plasma and tissue, which would be much more informative than a typical phase one file.
We anticipate exiting phase one with not only safety data, but also with critical data on potential exposure in both plasma and tissue, which would be much more informative than a typical phase one trial.
Speaker 2: In addition to progressing towards phase one, we continue to expand our intellectual property coverage for the NaviCAP platform. Recently, we received notice of allowance of a new patent that encompasses the novel treatment paradigm of our BT600 program with its targeted delivery of JAK inhibitors to the GI tract.
In addition to progressing towards phase one we continue to expand our intellectual property coverage for the Medicare platform recently, we received notice of allowance of a new patent that encompasses the novel treatment paradigm of our B T 600 program with its targeted delivery of JAK inhibitors for the Gi tract.
Speaker 2: We will share more details in the coming weeks when the patent issues.
We'll share more details in the coming weeks when the patent issues.
Earlier. This year, we were awarded another group of U S and European patents that extended our coverage for additional therapeutic targets, but you see we hold one of if not the world's most comprehensive IP portfolio for drug delivery using injectable devices with 30 patent families for the magic App platform alone.
Speaker 2: As we progress our UC program, we gain more data on the overall platform and the combination of IP and platform development will allow us to expand our pipeline organically with additional programs. Moving on to our Biojet systemic therapy.
As we progress our UC program, we gain more data on the overall platform and the combination of IP and platform development will allow us to expand our pipeline organically with additional programs.
Moving onto our bio jet systemic therapeutics platform.
Speaker 2: Our goal with the BioJet platform is to provide needle-free oral delivery of therapeutic molecules. The BioJet platform is based on a small capsule that, once swallowed, is designed to deliver drug into the wall of the small intestine using liquid jet injection. We believe the BioJet platform can provide an alternative to needle-based delivery of complex molecules and could also enable those molecules to more efficiently reach the liver through delivery into the small intestine.
With the Baidu platform is to provide needle free oral delivery of therapeutic molecules advisor platform is based on a small capsule that one swallow. It is designed to deliver the drug into the wall of the small intestine using liquid jet injection. We believe the budget platform can provide an alternative to needle based delivery of comp.
Flex molecules and could also enable those molecules to more efficiently reach the liberty for delivery into the small intestine.
Speaker 2: As planned, during Q3, we continued development and testing to confirm the performance of our next-gen BioJet 2 device, which allowed us to progress further and begin testing our pharma collaborators' molecules with the device.
As planned during Q3, we continued development and testing to confirm the performance of our Nextgen Biogen two device, which allowed us to progress further and begin testing our pharma collaborators molecules with the device.
Speaker 2: In October , we presented new data at the European Association for the Study of Diabetes, where we confirmed that our BioGeo2 device exceeded its performance targets. Across three studies in a porcine model, 96% of animals showed somaglutide in systemic circulation at clinically relevant levels for up to 10 days following administration.
Tobey, we presented new data at the European Association for the study of diabetes, where we confirm that our barge up to device exceeded its performance targets across these studies and of course I'd model, 96% of animals showed some of them have tied in systemic circulation at clinically relevant levels for up to 10 days following.
[noise] administration.
Speaker 2: Among the 22 animals dosed with somaglutide, oral bioavailability averaged 20.5%, which exceeds both the device performance and bioavailability targets set by us and our collaborators.
The 22 animals dosed with southern tide, oral bioavailability averaged 25%, which exceeds both the device performance and bioavailability targets set by us and our collaborators.
Speaker 2: Data analysis from animal studies were also completed with one of our collaborators molecules to demonstrate the potential of the biojet platform to achieve uptake of large molecules into the liver. Many disease targets reside in the liver, and it's a key area of focus for RNA-based therapeutics, such as antisense oligonucleotides or siRNA-based drugs.
Data analysis from animal studies will also completed with one of our collaborators molecules to demonstrate the potential of the biogen platform to achieve uptake of large molecules into the liver kidney disease targets reside in the liver and it's a key area of focus for RNA based therapeutics, such as anti sense oligonucleotide.
Or S I RNA based drugs.
Speaker 2: Large molecules must typically be delivered via IV or sub-Q injection because they cannot survive the stomach acid and are too large for absorption through the small intestine.
Large molecules, most typically be delivered via IV or sub Q injection, because they cannot survive the stomach acid and are too large for absorption through the small intestine.
Speaker 2: The challenge with IV or Sub-Q delivery is most of the drug is metabolized before it reaches the liver.
The challenge with I D I V or sub two delivery is most of the drug is metabolized before it reaches the lever.
Our technology uses liquid injection into the small intestine, which is the optimal pathway to the liver.
Speaker 2: for the BioJet platform to provide a unique advantage for liver-targeted oral delivery of large molecules. While we aren't clear to share data yet, I can say that the results of the study with our collaborators' molecules were extremely encouraging.
So the biotech platform to provide a unique advantage for liver targeted all delivery of large molecules, while we arent clear to share data yet I can say that the results of the study with our collaborators molecule.
Cleanly encouraging.
Speaker 2: We also recently completed another set of animal studies for a second collaborator and are in the process of having the hundreds of samples analyzed. These data, they provide further support for the biojet platform's ability to deliver large molecules.
We also recently completed another set of animal studies for a second collaborator and are in the process of having the hundreds of samples to analyze these data. It provides further support for the Biogen platform's ability to deliver large molecules in.
Speaker 2: In addition, we're initiating preclinical studies with a third pharma collaborator. As we continue the progress of the BioJet platform and produce further data, we have seen increasing interest from potential partners, and we're actively negotiating an agreement with a fourth potential pharma collaborator.
In addition, we're initiating preclinical studies with a food pharma collaborators as we continue the progress of the Baidu platform and produce further data we have seen increasing interest from potential partners and we're actively negotiating an agreement with a potential pharma collaborators at.
Speaker 2: It is common for research collaborations to have strict confidentiality requirements early on.
It is common for research collaborations to have strict confidentiality requirements early on.
Speaker 2: particularly those involving very large companies and highly competitive drugs. We appreciate the need to share as much information as possible with our stakeholders, but we rely on our collaborators' permission and timing to share information.
Taking their lead those involving very large companies and highly competitive drugs.
We appreciate the need to share as much information as possible with our stakeholders.
But we rely on our collaborators permission and timing to share information.
Speaker 2: We'll continue to be as transparent as possible while being good partners and respecting the disclosure rules established with our collaborators.
We will continue to be as transparent as possible, while being good partners and respecting the disclosure rules established with our collaborators.
Speaker 2: We believe we're well-positioned with the BioJet platform's several advantages. Its ability to achieve category-leading bioavailability of complex molecules, its ability to deliver existing liquid formulations and large payloads in the multi-milligram range, and its potential to enable liver-targeted delivery of large molecules.
We believe we are well positioned with the Baidu platform several advantages its ability to achieve category, leading by availability of complex molecules.
Ability to deliver existing liquid formulation and large payloads in the multi milligram brain and its potential to enable liver targeted delivery of large molecule.
Speaker 2: We're excited to see the accelerating development of the BioJet platform and we look forward to sharing more about the progress with our existing and new collaborators and potential partners.
Excited to see the accelerating development of the Baidu platform and we look forward to sharing more about the progress with our existing and new collaborators and potential park.
Speaker 2: to summarize our anticipated milestones. For our NaviCAP platform, we await the FDA's response for R&D application, and we anticipate initiating our phase one trial before the end of the year.
Otherwise our anticipated milestones for another kind of platform, we await the Fda's response to our R&D application and we anticipate initiating a phase one trial before the end of the year.
Speaker 2: Initial Phase 1 data is anticipated early next year, and if we begin the trial before the end of this year as planned, we expect to complete the execution of the trial in Q1, with final data coming after that. For our BioJet platform, we expect to continue generating data from animal studies with the molecules of our pharma collaborators during the fourth quarter.
Initial phase one data is anticipated early next year and if we begin the trial before the end of this year as planned we expect to complete the execution of the trial in Q1 with final data coming after that for our bio jet platform. We expect to continue generating data from animal studies with the molecules of a pharma collaborators during the fourth quarter.
With preexisting and potentially a fourth new collaboration all generating data that add to the overall development dataset of the platform, we anticipate accelerating interest from others.
Speaker 2: With three existing and potentially a fourth new collaboration, all generating data that add to the overall development data set of the platform, we anticipate accelerating interest from others.
Speaker 3: With that, I will now turn the call over to Eric for review of our financial results and capital market activities. Thanks, Andy, and good afternoon, everyone.
With that I will now turn the call over to Eric for a review of our financial results and capital market activities.
Thanks, Andy and good afternoon, everyone.
We had a number of financial activities during the third quarter.
Speaker 3: We made significant progress on optimizing our capital structure by materially reducing our convertible notes balance by $60 million through a notes exchange agreement.
Made significant progress in optimizing our capital structure.
Materially, reducing our convertible notes violence by $60 million.
Its exchange agreement.
Speaker 3: We remain actively engaged with convertible note holders to further enhance our capital structure to be more aligned with our company profile.
We remain actively engaged with convertible note holders to further enhance our capital structure to be more aligned with our company profile.
Speaker 3: I'm happy to share that we're making progress to further reduce our convertible note balance through a new potential note exchange with the possibility to generate additional funding for the company. We expect to have further announcement on
I'm happy to share that we're making progress further reduced our convertible note balance.
A new potential notes exchange with the possibility to generate additional funding for the company.
We expect to have further announcements ambition in near term.
Speaker 3: As a result of those activities, we have some non-recurring and non-cash entries in our Q3 financial results, which I will explain in more detail.
As a result of those activities, we have some nonrecurring and noncash entries in our Q3 financial results, which I will explain in more detail.
Speaker 3: Operating expenses were $23.3 million for the first three months ended September 30th, 2023, compared to $14.9 million for the three months ended June 30th, 2020.
Operating expenses were $23 $3 million for the first three months ended September 32023.
Parents with $14 $9 million for the three months ended June 30th.
Great.
Speaker 3: The increase was mainly attributable to a one-time stock-based compensation non-cash charge of approximately $9 million related to vesting of employees' restricted stock units.
The increase was mainly attributable to a one.
One time stock based compensation noncash charge.
<unk> $9 million when they took the best thing of employees' restricted stock units.
Speaker 3: As a result, operating expenses excluding stock-based compensation expenses effectively remain stable at $12.8 million with continued investment in device development, preclinical studies, and INV enabling activities.
As a result operating expenses, excluding stock based compensation expenses effectively remains stable at $12 $8 million with continued investment in device development preclinical studies and I M D enabling activities.
Speaker 3: Breaking this down, GN expenses in the third quarter were $6.9 million excluding stock-based compensation expenses.
Breaking this down G&A expenses in the third quarter were $6 $9 million, excluding stock based compensation expenses, while R&D expenses in the third quarter were $5 9 million Ballrooms also excluding stock based compensation expenses.
Speaker 3: while R&D expenses in the third quarter were $5.9 million, also exceeding Fed-based compensation expenses.
Speaker 3: We continue to streamline our G&A expenses and are making good progress in focusing our investments on our R&D program.
We continue to streamline our G&A expenses and are making good progress in focusing our investments on the R&D programs.
Speaker 3: While legacy span has substantially been reduced over the last few quarters, it still represented more than 30% of our GME cash spend in Q3, and we continue working actively to reduce it going forward, with further substantial changes by early next year.
While legacy Spanish substantially been we didn't so far the last few quarters. It still represented more than 40% of our G&A cash then Q3, and we continue working actively to reduce it going forward with further substantial changes by early next year.
Speaker 3: Our core OpExpand remains focused on our R&D programs as we rapidly move towards the clinic.
Our core Opex spend remains focused on our R&D programs as we rapidly move towards that.
Speaker 3: We maintain our guidance of an average monthly operating cash burn of approximately $4 million.
We maintain our guidance of an average monthly operating cash burn of approximately $4 million.
Speaker 3: Net loss for the quarter was $73.5 million.
Net loss for the quarter was $73 $5 million. This includes non cash charges for stock based compensation expenses of $9 million noted earlier.
Speaker 3: This includes non-cash charges to stock-based compensation expenses of $9 million noted earlier and a non-cash charge of $53.2 million attributable to the convertible note exchange implemented by the company in September . As a result, our effective operating cash burn for the quarter was $12.7 million.
And a noncash charge of $63 $2 million attributable to the convertible notes exchange implemented by the company in September.
As a result, our effective cash operating cash burn for the quarter was $12 $7 million.
Speaker 3: On the fundraising front, we successfully raised almost $6 million in gross proceeds through different sources since our last call.
On the fund raising funds, we successfully raised almost $6 million in gross proceeds.
Some sources since our last call.
Speaker 3: We successfully monetized some remaining legacy assets, including our Ann Arbor lab building.
We successfully monetize some remaining legacy assets, including our Ann Arbor Lab building.
Speaker 3: We continue to target non-dilutive sources of funding and actively engage with the investor community to ensure access to the necessary capital needed to fund the development of our program.
We continue to target non dilutive sources of funding and actively engaged with the investor community to ensure access to the necessary capital needed to fund the development of our programs.
Speaker 3: We've also seen keen interest from investors in supporting our programs through direct capital investment in Bayeux, and we've already raised meaningful capital through the channel so far this quarter.
We've also seen keen interest from investors and supporting our programs to direct capital investments and buyer and we've already raised meaningful capital for that channel. So far this quarter.
With that I will now turn the call back over to Eddie.
Speaker 3: With that, I will now turn the call back over to Adi.
Speaker 4: Thanks, Eric. BioRock continues to make strides with both our NaviCAP platform, where we're focused on entering the clinic with our BT600 program, and our BioJet platform, where we're focused on progressing our pharma collaboration. We look forward to providing further updates as we achieve our milestone. Operator, we're now ready for questions.
Thanks, Eric.
<unk> continues to make strides with both our <unk> platform, where we are focused on entering the clinic with our P. T 600 program.
And our biotech platform, where we're focused on progressing our pharma collaboration.
We look forward to providing further updates as we achieve our milestone operator, we're now ready for questions.
Thank you well now be conducting a question and answer session. If you'd like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue. You May press star two if you'd like to remove your question from the queue for participants using speaker equipment and they'd be necessary to pick up your handset before pressing the Turkey one moment.
Speaker 1: If you'd like to ask a question, please press star 1 on your telephone keypad. The confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to remove your question from the queue. For participants, use speaker equipment and it may be necessary to pick up your handset before pressing the star key. One moment please while we pull up your question.
While we poll for questions.
Speaker 1: Thank you. Our first question is from Joe Pangenis with H.C. Wainwright. Please proceed with your question.
Thank you. Our first question is from Joe Penn Gena with H C. Wainwright. Please proceed with your question.
Hey, guys. Good afternoon. Good afternoon. Thanks for taking the question. So first a question on the B T 600, I M D.
Was this more of just providing more understanding and clarification in your answers or is there anything rate limiting in the answers in response as expected with regard to getting the study started.
Speaker 5: Was this more of just providing more understanding and clarification?
Speaker 2: Yeah, hi, Joe. So I think we mentioned in the script that
Yeah, Hi, Joe.
So I think we mentioned in the script that.
Speaker 2: The FDA asked some clarifying questions and
The FDA ask some clarifying questions and.
Speaker 2: Several of them were related to our device and, you know, about the early development of the device. We had the information and so, which is why we were able to provide that and turn it around within a few days. And.
Several of them were related to our device and you know about the early development of the device.
We have the information and so which is why we were able to provide that and turn it around within a few days.
So at this point.
Speaker 2: All the information is back and we hope that the FDA is quickly finishing the rest of their review.
All the information is back and [noise].
We hope that the FDA has quickly finishing the rest of their review.
No that's great. Thank you and then.
Speaker 5: i guess for both programs but also for a bt six hundred and uh... uh... beyond for navigate
I guess for both programs, but also for <unk> 600 and beyond.
Beyond for <unk> sort of continue on the manufacturing you know sort of where do you stand right now with regard to being able to supply you know all the patients for the phase one program and sort of any potential near term needs for that as well as the bio jet program.
Yeah, a good question.
Speaker 2: So for BT600, you know, along with this review, we're doing everything on our end that we can control.
So for <unk> 600, you know along with this review we are doing everything on our end that we can control.
Speaker 2: to get ready for a phase one trial, which means getting our sites ready, getting our partners, the CROs ready, doing everything we can, including doing supply. So we have already produced what we expect to use for the phase one trial. So we'll be ready with the site, the protocols, the supply, everything ready to go for the BT600.
To get ready for a phase one trial, which means getting our sites ready getting our partners. The crows ready doing everything we can including doing supply. So we have already produced what we expect to use for the phase one trial, so we'll be ready with.
The site the the protocols the supply everything ready to go for the <unk> 600 <unk>.
Speaker 2: Slightly different for BioJet. We don't really need to make a lot of these at this point, even though we use 10, 20 different animals and a few doses. It is still only a handful of devices, and we're able to make those on an ongoing basis. We're making some great progress with multiple studies coming back to back to back, but it's still a very manageable number of devices, and we're able to easily make those and continue progressing our program.
Slightly different for Biogen, we don't really need to make a lot of these at this point even though.
We used 10 20 different animals in a few doses. It is still only a handful of devices and we're able to make those on an ongoing basis, we're making some great progress with multiple studies coming back to back to back, but it's still a very manageable number of devices and we're able to easily make those.
And continue progressing our programs.
Great. Thanks for the color.
Speaker 1: Thank you. Our next question is from Julian Harrison with PTIG. Please proceed to your.
Thank you. Our next question is from Julian Harrison with <unk>. Please proceed with your question.
Speaker 6: Hi, thank you for taking my questions. I guess some more on the IND resubmission. Can you talk more about the expected timeline to turn this around? Is this standard 30 days, something longer, something shorter? And then also, do you plan to press release first human dose?
Hi, Thank you for taking my questions.
Yes, some more on the Resubmission.
Resubmission can you talk more about the expected timeline to turn this around as you know a standard 30 days something longer something shorter and then also do you plan to press release first human dose.
Hi, Julien so in terms of the review you know we very much appreciate that the S. T. S. Workload you can imagine has been really busy they've had a lot to do and that's also apparent from some other places where they've needed more time.
Speaker 2: Hi Julian. So in terms of the review, you know, we very much appreciate that the FDA's workload you can imagine has been pretty busy. They've had a lot to do. And that's also apparent from some other places where they've needed more time.
Speaker 2: They don't have a great mechanism for adding time to the 30-day cycle, which is what we were kind of talking about that looked toward the end of the cycle when they had these questions, even though we only needed a couple of days to gather the information, turn it around, would have ended.
I don't have a great mechanism for adding time to the 30 day cycle, which is what we were kind of talking about that look towards the end of the cycle. When they have these questions. Even though we only needed a couple of days to gather the information turn it around we would have ended with a 30 day clock running out and so the best thing to do is to.
Speaker 2: with the 30-day clock running out, and so the best thing to do was to resubmit. So the resubmission was more of a just a tactical, let's just go ahead, provide the information, resubmit, and it goes back now into a standard 30-day clock. So.
Resubmit so the Resubmission was more of a just a tactical let's just go ahead provide the information resubmit and it goes back now into a standard 30 day clock. So.
Speaker 2: What we hope is that they finish their review very quickly and that in November .
What we hope is that they finished their review very quickly and that in November.
Speaker 2: to get a clearance from the FDA. And that's how we're preparing. We're preparing, given the interactions we've had, they've been, you know, they've been great. We've had, really, we appreciate the way they've worked with us. We've had several conversations. And so we hope that they'll finish the review. We expect that we get a clearance in November , which is why we're doing everything to prepare for a start of trial in December .
You get a clearance from the FDA and that's how we are preparing we're preparing given the interactions. We've had they've been you know they've been great. We've had really we appreciate the way they have to work with US we have had several.
Several conversations and so we hope that they'll finish the review we expect that we get a clearance in November and which is why we're doing everything to prepare for a startup trial in December.
Thanks very much.
Yeah.
Speaker 1: Thank you. Our next question is from John Vandermosten with Zax. Please proceed with your question.
Thank you. Our next question is from John Bender Moskin with Zacks. Please proceed with your question.
Speaker 7: All right, thank you, and hello, Adi and Eric. Can you give us a sense of any other checklist items that need to be completed besides the FDA clearance on the BT600 trial before you can start your first administration?
Alright, Thank you and Hello, Eddy and Eric.
Can you give us a sense of any other checklist items that need to be completed a beast.
Besides the FDA clearance on the a B T 600 trial before you can start your first are you first administration.
Yeah, Hi, John so.
Like I said, what we're doing is going through that checklist of everything that we control and so making enough material getting all the supply ready getting the site ready.
Speaker 2: Like I said, what we're doing is going through that checklist of everything that we control. And so making enough material, getting all the supply ready, getting the site ready, getting our partners, the CROs ready, getting the protocols ready, getting the IRB ready. We're doing all of those, and they're well on track, and we would be ready with all of those.
Getting our partners the Cro's ready getting the protocols ready getting the IRB ready, we're doing all of those and they are well on track and we would be ready with all of those.
Any day that we get the clearance from the F D. A.
Speaker 2: any day that we get the clearance from the FDA. What we're not controlling is the review with the FDA. So we're working closely with them and we're hoping that we get that done in November . And so tentatively, we're planning that all the stuff we have to get ready on that checklist really is done. And that in December , as soon as we get the clearance, we go activate the sites, do what we need to do.
We're not controlling is the review with the FDA. So we're working closely with them and we're hoping that we get that done in November and so tentatively we are planning that.
All the stuff we have to get ready on that check list really is done and that in December as soon as we get the clearance. We go activate the sites do what we need to do.
Speaker 2: And I think like somebody else mentioned, we can then share when we have started the trial in December .
And I think like somebody else mentioned, we can then share when we have started the trial in December.
Speaker 7: Very good. Yeah, it sounds like it could start very shortly after you get.
Okay very good yeah. It sounds like it could start very shortly after you get the clearance.
Speaker 7: And then moving on to BioJet, when do you think you'll have serious discussions with the BioJet partners on going to the next step, which would be in the clinic and which might include potential milestones and things like that? When do you achieve or reach that stage?
And then moving onto to bio jet when do you think you'll have serious discussions with the Biogen partners on going to the next the next step which would be in the clinic and you know which might include potential milestones.
Milestones and things like that when when do you achieve a reach that stage.
Yeah.
That's an interesting question. So the way I would hope we are we're being clear people to understand what we have now our research collaborations. These are great. These are ways, where large companies work with innovative technologies like ours.
Speaker 2: That's an interesting question. So the way I would hope we're being clear, people to understand. What we have now are research collaborations. These are great. These are ways where large companies work with innovative technologies like ours.
Speaker 2: because they find that there is a potential that they could use that, they're interested in it, but they'd like to learn how our technology and their molecules kind of work, and this is a way where we can get some.
Because they find that there is a potential that they could use that.
They're interested in it but they'd like to learn how our technology of their molecules kind of work.
And this is a way where we can get some.
Speaker 2: cost-sharing, but the main idea here is to learn how the two work together. Progressing through those...
Cost sharing but the main idea here was to learn how the two work together.
Aggressively through those.
Speaker 2: is what leads to the next stage of conversations, which then is about what I would call a partnership. So I'm qualifying.
Is what leads to.
The next stage of conversations, which then is about what.
What I would call the partnerships on qualifying.
Speaker 2: these relationships, which we have, which are very much like partners, but they really are research collaborations, and progressing those into partnerships, which then look like what, you know, many people might be used to seeing, whether it's licensing or some other sort of partnership that comes with an upfront payment, a plan, milestones. That's when you get into the.
These relationships ships, which we have which are very much like partners, but they really are research collaborations.
Progressing those into partnerships, which then looked like what you know many people might be used to seeing whether it's a licensing or some other sort of partnership that comes with an upfront payment.
Planned milestones.
So that's when you get into discussions about.
Speaker 2: what kind of molecule, what kind of indications, what maybe a clinical plan might look like. There might be some situations where the company, like ours, helps them with those. There might be some where we allow them to run with it, and they come up with their own plans. So I think what needs to be more near-term
What kind of molecule, what kind of kind of indications of.
What maybe a clinical plan might look like there might be some situations where the company.
Like ours helps them with those that might be some where we.
It allows them to run with it and they come up with their own plans. So I think what needs to be more near term focus is that we are seeing tremendous progress with these collaborations over the last several months, we've gotten way better at execution right we have.
Speaker 2: is that we are seeing tremendous progress with these collaborations. Over the last several months, we have gotten way better at execution, right? We have.
Speaker 2: We've made the BioJet 2, which is our next-gen device. We've done the animal studies to make sure that the device works. We've then showed it to our collaborators who agree that the device works to a point where they want to include their molecules. We've run their molecules in our device, and we've gotten that initial first one's data. We're expecting the second one's data. In a month or two, we'll get the third one's data. Those data are what...
We've made the Biogen two which is our next gen device, we've done the animal studies to make sure that the device works. We then showed it to our collaborators who agree that the device works to a point where they want to include their molecules. We've run their molecules in our device and we've gotten that initial first one's data we're expecting the <unk>.
Second one's data in a in a month or two we'll get the third one's data those data is what our what.
Speaker 2: enable us to then have the conversation of, okay, given that this combination works, how do you see this relationship? So those could be near-term, pretty interesting inflections, and they lay out certainly what the development path is, but for a small company, they could mean significant things in terms of how investors might view our relationships with, at that point, partners.
Enable us to then have the conversation okay. Given that this combination works how do you see this relationship so those could be near term what are your interesting inflections.
And they lay out certainly what the development path is but we're a small company they could mean significant things.
In terms of how investors might view, our relationships with at that point partners.
Speaker 2: The data obviously is getting good enough, which is why I mentioned that we're seeing the accelerated interest. We're getting more incoming people asking us about working with us. And that's why we were able to say we've already got a discussion with a fourth collaborator that could lead to a research collaboration in the near term.
The data obviously is getting good enough, which is why I mentioned that we're seeing the accelerated interest we're getting more incoming people asking us about working with us.
That's why we are where we were able to say we've already got a discussion with our fourth collaborator that.
Could lead to a research collaboration in the near term another Big company. So we see that this data generation translating into what could be meaningful partnerships being the short term thing to focus on with Biogen and then later next year worrying about what a clinical plan might look like.
Speaker 2: another big company. So we see that this data generation translating into what could be meaningful partnerships being the short-term thing to focus on with Biojet and then later next year, worry about what a clinical plan might look like.
Okay and now this fourth collaborator since you've done a lot of the preclinical work already and so some of your partners are they coming in at kind of a later stage, where they kind of already know what to expect and you might be a lot closer to moving onto an advanced relationship, but the fourth partner.
Speaker 7: Okay. Now, this fourth collaborator, since you've done a lot of the preclinical work already and so have some of your partners, are they coming in at kind of a later stage where they kind of already know what to expect and you might be a lot closer to moving on to an advanced relationship with the fourth partner? Where does that stand, just given all the preliminary work that's already been done for BioJet?
Or where does that stand just given all the all the preliminary work that's already been done for Biogen.
Speaker 2: I think the way I see it is that.
Yeah, I think the way I see it is that.
Several whatever a year or two ago when we have these other collaborations.
Speaker 2: several, whatever, a year or two ago when we had these other collaborations, those discussions were around early stage, our first gen, our BioJet 1 device. And so we worked with these collaborators to do things like establish success criteria, which is why we talk about meeting targets, establishing development of our device milestones.
Those discussions were around.
Early stage, our first Gen. Our Biogen one device and so we work with these collaborators to do things like established success criteria, which is why we talk about meeting targets, establishing development of our device milestones.
Speaker 2: All of those, now that we've completed, we're now looking at the next stage of, okay, go ahead and try our molecules. So this fourth collaborator would come in at that stage of go ahead and try, try our molecule because they've seen this other data and.
All of those now that we've completed we're now looking at the next stage of Okay. Go ahead and try and molecules. So this fourth collaborator would come in at that stage of go ahead and try try a molecule because they've seen this other data and.
Speaker 2: That's what encourages me, right? That people are seeing that we've done the development work, we've done the core work, we now have several molecules that we've run with this device, and it's all meeting those general commercial.
That's what encourages me right that people are seeing that we've done the development work. We've done the core work. We now have several molecules that we've run with this device.
And it's all meeting those general commercial performance targets that people want to see and so now it's about working with their molecule and depending on how that goes.
Speaker 2: targets that people want to see and so now it's about working with their molecule and depending on how that goes quickly progressing that relationship so certainly that should move
Quickly progressing that relationship so suddenly that should move much faster than our earlier collaborators.
Speaker 2: much faster than our earlier collaborators, collaborations have moved. But we're excited about all of them. So we are at that point, right, with the other collaborators where
Collaborations have moved but we're excited about all of them. So we are at that point right with the other collaborators were.
We're getting starting to get data.
Speaker 2: We're getting starting to get data with their molecules. That allows us to have those next conversations.
With their molecules that allows us to have those next conversations.
Great Alright, Thank you Andy I appreciate it.
Okay.
Thank you.
Speaker 1: There are no further questions at this time. I'd like to hand the floor back over to Adi Mohanty for any closing.
There are no further questions at this time I'd like to hand, the call back over to Eddie Mohanty for any closing comments.
Well. Thank you again for joining us today for our financial results call. We're excited about the progress, we're making and we look forward to keeping you updated.
Speaker 2: Well, thank you again for joining us today for our financial results call. We're excited about the progress we're making, and we look forward to keeping you updated. Thank you.
Thank you have a good evening.
Speaker 1: This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.
This concludes today's conference.
Connect your lines at this time, thank you for your participation.