Q4 2021 Rani Therapeutics Holdings Inc Earnings Call
Welcome to the Ronnie Therapeutics fourth quarter, and full year 2021 financial results and corporate update conference call. At this time all participants are in a listen only mode. Following management's prepared remarks, we will hold a question and answer session to ensure that we have ample time for every guest every month.
Welcome to the Ronnie Therapeutics Fourth Quarter and Full-Year 2021 Financial Results and Corporate Update Conference Call. At this time, all participants are in a listen-only mode.
following management's prepared remarks, we will hold a question and answer session. To ensure that we have ample time to address everyone's questions during the Q&A session, we would ask for a limit of one question and one follow-up question per person.
Questions during the Q&A session.
Would ask for a limit of one question and one follow up question per person.
To ask a question at that time, please press star followed by one on your touchtone telephone.
Ask a question at that time. Please press star followed by one on your Touchtone telephone if anyone has difficulty hearing the conference call. Please press star zero for operator assistance.
If anyone has difficulty hearing the conference call, please press star 0 for operator assistance.
As a reminder, this call is being recorded today, Tuesday, March 29, 2022. I would now like to turn the conference over to Lawrence Watts, Managing Director at Gil Martin Group. Please go ahead.
As a reminder, this call is being recorded today Tuesday March 29, 2022, I would now like to turn the conference over to Lauren What's managing director at Gilmartin Group. Please go ahead.
Thank you operator.
Lawrence Watts: Joining us on the call today from Rani Therapeutics are Chief Executive Officer Talat Imran, Chief Financial Officer by Sanford, and Chief Scientific Officer Meir Hashe.
Joining us on the call today from Ronny Therapeutics, <unk>, Chief Executive Officer, Brian <unk>, Chief Financial Officer by Sanford and Chief Scientific Officer Mia Hudson.
Lawrence Watts: During the call, management will make forward-looking statements that are subject to risks and uncertainties related to future events and or financial performance of the company.
During the call management will make forward looking statements that are subject to risks and.
I think as it relates to future events and all financial performance of the company.
Lawrence Watts: These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, such as, but not limited to, those discussed in the risk factors section of the company's filings with the Securities and Exchange Commission, including its annual report on FOM-10K and quarterly reports on FOM-10Q, which identify the specific factors that may cause actual results or events to differ materially from those described in these forward-looking statements.
These forward looking statements are subject to a number of risks uncertainties and assumptions such as but not limited to those discussed in the risk factors section of the company's filings with the Securities and Exchange Commission, including its annual report on Form 10-K .
He reports on Form 10-Q , which identify the specific factors that may cause actual results or events to differ materially from those described in these forward looking statements.
Lawrence Watts: These factors may include, without limitation, statements regarding product development and clinical trials, product potential, the regulatory environment, certain business strategies, capital resources, or operating performance.
These factors may include without limitation statements regarding product development and clinical trials product potential the regulatory environment sudden business strategies capital resources or operating performance.
Lawrence Watts: actual results and the timing of events could differ materially from those projected in such forward-looking statements.
Actual results and the timing of events could differ materially from those projected in such forward looking statements.
Speaker Change: With that, I will turn the call over to Talat Imran, Chief Executive Officer of Rani.
With that I will turn the call over to Talbott, you Bryan Chief Executive officer abroad to lapse.
Talat Imran: Thank you, Lawrence. Good afternoon, everyone, and thank you all for joining our fourth quarter and full year 2021 financial results conference.
Thank you Warren.
Good afternoon, everyone and thank you all for joining our fourth quarter and full year 2021 financial results Conference call.
Talat Imran: 2021 proved to be a transformative period for Ronnie therapeutics during the year the company completed an initial public offering on NASDAQ expanded its executive leadership progress its development pipeline and made further progress optimizing the Ronnie pill oral delivery.
2021 proved to be a transformative period for Ronnie therapeutics during the year. The company completed an initial public offering on NASDAQ expanded its executive leadership Progressive development pipeline and made further progress optimizing the Ronnie pill oral delivery platform.
Before I turn to recent again I would like to start today's call by going over the key milestones we achieved in 2021.
Speaker Change: Before I turn to recent events, I would like to start today's call by going over the key milestones we achieved in 2021. Our most notable achievement was the completion of the successful IPO in August , which raised approximately $84 million in gross proceeds. As a result, Ronnie exited the year in a strong financial position. On a personal note, I was honored to be appointed CEO prior to us going public and to lead Ronnie's therapeutics through the IPO process.
Notable achievements was the completion of the successful IPO in August which raised approximately $84 million gross proceeds as a result, ronny exited the year in a strong financial position.
On a personal note I was honored to be appointed CEO prior to us going public and to lead Ronnie therapeutics through the IPO process.
Speaker Change: In 2021, Ronnie's executive team was further bolstered by the appointment of Eric Bruin to General Counsel.
In 2021, Ronnie's executive team was further bolstered by the appointment of Eric Bowen to General Counsel.
Speaker Change: We also expanded our non-executive team welcoming Lynn Baranowski, Lauren DeBolmeaux, and Jean-Luc Patel to our board of directors with Lisa Rometti joining our board in January .
We also expanded our nonexecutive team welcoming Lindbergh now ski Loring de Bono and John Luke Patel to our board of directors with Liza <unk>, joining our board in January .
Speaker Change: Turning to our operations, we have made significant progress in refining and furthering our drug development plans over the past year.
Turning to our operations, we have made significant progress in refining and furthering our drug development plans over the past year.
Speaker Change: Following our positive phase one study results for oral octreatyde using our original Ronnie Hill capsule, which were announced in 2020, and which served as a proof of concept for our injectable to oral delivery platform, we further refined not only the platform itself, but also our near term clinical development plans for the oral delivery of bylaw.
Following our positive phase one study results for oral octreotide using our original Ronnie pill capsule, which were announced in 2020 and which serve as a proof of concept for our injectable to oral delivery platform. We further refined not only the platform itself, but also our near term clinical development plans for the oral delivery of.
Biologics.
As a reminder, the original Ronnefeldt capsule can deliver doses of up to three milligrams of drug per pill.
Speaker Change: As a reminder, the original Ronnie pill capsule can deliver doses of up to 3 milligrams of drug per pill. This capacity enables us to pursue a whole host of disease indications, including neuroendocrine tumors or NETs, achromegaly, psoriatic arthritis, growth hormone deficiency, osteoporosis, and hyperparathyroidism.
This capacity enables us to pursue a whole host of disease indications, including neuroendocrine tumors or naps acromegaly Psoriatic arthritis.
Hormone deficiency, osteoporosis and hyperparathyroidism pair.
Speaker Change: Parathyroid hormone, or PTH, is administered by daily injections for the treatment of osteoporosis and quickly became a key focus for us and led to the development of our drug candidate, RT102.
Parathyroid hormone or PTH is administered by a daily injections for the treatment of osteoporosis and quickly became a key focus for us and led to the development of our drug candidate <unk> hundred two.
As such in November we completed the G. L. P. Seven day repeat dose oral administration study that evaluated the safety and Tolerability of <unk>, one or two in a canine model.
Speaker Change: As such, in November , we completed a GLP seven-day repeat dose oral administration study that evaluated the safety and tolerability of RT-102 in a canine model. The study demonstrated successful delivery of a PTH payload via the Ronnipil capsule with a pharmacokinetic profile comparable to the published data for once daily PTH subcutaneous injection.
The study demonstrated successful delivery of the PTH payload via the Ronnie pill capsule with a pharmacokinetic profile comparable to the published data from once daily <unk> PTH subcutaneous injection.
Speaker Change: I'm happy to announce that our second clinical program began last week with the initiation of our phase one study of RT-102 for osteoporosis.
I'm happy to announce that our second clinical program began last week with the initiation of our phase one study of RG, one or two for osteoporosis.
Speaker Change: The initiation of this study represents a significant milestone for Ronnie as our second program to enter the clinic.
Initiation of this study represents a significant milestone for Ronnie as our second program to enter the clinic.
Speaker Change: We intend to initiate another phase one study with RT109, our oral human growth hormone program, in the second half of the year.
We intend to initiate another phase one study with <unk> 109, our oral human growth hormone program in the second half of the year.
Now, let me turn to our other major developing in Michigan.
Speaker Change: Now let me turn to our other major development initiative, the Ronnie Pill HC, a newly designed high-capacity oral biologic delivery device capable of administering 500% plus higher payloads than our current Ronnie Pill caps.
Till HC, a newly designed high capacity oral biologic delivery device capable of administering 500% plus higher <unk> than our current Ronnie pill counts.
Speaker Change: We believe this is a significant breakthrough in drug delivery with the potential to provide expansive opportunities for the company such that we could potentially pursue a daily dosing option for over 50 additional biologics for internal development or through partnership.
We believe this is a significant breakthrough in drug delivery with the potential to provide expansive opportunities for the company such that we could potentially pursue a daily dosing option for over 50, additional biologics for internal development or through partnerships.
Speaker Change: Importantly, we believe this development will not detract from us making progress with our original Ronnie Pill Castle, which forms the core of our current development pipeline.
Importantly, we believe this development will not detract from us, making progress with our original Ronnie <unk> capsule, which forms the core of our current development pipeline.
Speaker Change: The current Ronnie Pill capsule is optimized for drugs with a daily dose of up to 3 milligrams. The Ronnie Pill HC can potentially deliver up to 20 mg.
Current LIFO capsule is optimized for drugs with a daily dose of up to three milligrams. The Ronnie till HC can potentially deliver up to 20 mix to give you an idea some of the potential drugs. So we can now target with Ronnie pill HC include timber leaves map Etanercept Trastuzumab and <unk>.
Speaker Change: To give you an idea, some of the potential drugs that we could now target with the RonnyPillHC include PembrolesaMab, Etanercept, TrastuceMab, and Sacrokinumab. From these alone, you should be able to tell the potential market opportunity for us with this higher capacity device is significant.
Beef alone you should be able to tell the potential market opportunity for us with this higher capacity device is significant.
Speaker Change: As we reported in February of this year, in a preclinical in vivo study, we successfully delivered an 18 milligram dose of drug in three canine test subjects using the Ronnipil-AC device placed by a laparotomy in the jujube.
As we reported in February of this year in a preclinical in vivo study, we successfully delivered an 18 milligram dose of drug and three canine test subjects using the Ronnie till HC device placed by a laparotomy and the <unk>.
Speaker Change: Systemic serum drug concentration was detected and measured over five days. Lastly, before I turn the call over to Mir to cover our preclinical data in more detail, I want to discuss the market research that we released on patient preference for ingesting an oil therapeutic over receiving an injection.
Systemic Jerome drug concentration was detected in measured over five days.
Lastly, before I turn the call over to Nir to cover our preclinical data in more detail I want to discuss the market research that we released on patient preference for ingesting in all therapeutic over receiving an injection.
We commissioned an independent third party survey to investigate U S patient and physician preference for oral medications versus injections with survey involves 611 patients aged 18 years or older and presently using an injectable biologic to treat a condition and 201 physicians.
Speaker Change: We commissioned an independent third-party survey to investigate U.S. patient and physician preference for oral medications versus injections.
Speaker Change: The survey involves 611 patients aged 18 years or older and presently using an injectable biologic to treat a condition and 201 physicians, mostly endocrinologists and rheumatologists presently prescribing injectable biologics to their patients.
Mostly endocrinologists and Rheumatologists presently prescribing injectable biologic to their patients.
Speaker Change: Across all patient groups, genders, ages, conditions treated, and severity of condition, there was a consistently strong preference for switching from injections to pills, even for infrequent injection regimens of up to six months.
Across all patient groups genders ages conditions treated and severity of condition. There was a consistently strong preference for switching from injection. So pills, even for infrequent injection regimens of up to six months.
Speaker Change: For example, for Prolia, which is administered as a subcutaneous injection, one 76 months, 76% of patients surveyed indicated a preference for a daily pill versus the current regimen. For Humira, which is dose five weekly, the percentage of patients who prefer daily pills was 88%.
For example for Prolia, which is administered as a subcutaneous injection. Once every six months, 76% of patients surveyed indicated a preference for a daily pill versus the current regimen for Humira, which is dose biweekly the percentage of patients who preferred daily pills was 88%.
Speaker Change: All groups surveyed indicated a preference for oral over-injectable drugs at or exceeding 64%. This demonstrates that there is a tremendous latent demand among patients for an oral alternative to many blockbuster biologic drugs. Together with the Ronny Pill HD, this presents a number of potential opportunities for expansion of Ronny's pipeline in the future.
All groups survey indicated a preference for oral or injectable drugs at or exceeding 64%. This demonstrates that there is a tremendous latent demand among patients for an oral alternative to many blockbuster biologic drugs together with the Ronnie <unk> see this presents a number of potential opportunities for expansion of <unk>.
<unk> pipeline in the future.
Speaker Change: In addition to the commissioned surveys, we conducted our own preference and tolerability study involving a mock Ronnie Pill capsule containing potato starch to evaluate the ease with which a Ronnie Pill capsule could be swallowed. Of the 150 individuals that participated, all were able to swallow the mock Ronnie Pill capsule with no reported difficulty. Remember, the Ronnie Pill is a triple O sized pill, similar in size to that of a fish oil.
In addition to the Commission survey, we conducted our own preference and Tolerability study involving a marked ronnie till capsule containing potato starch to evaluate the ease with which ronnefeldt capsule could be swap.
Of the 150 individuals' that participated all were able to swallow the Moc Chronicle capsule with no reported difficulty remember the Ronnie pillars, a triple O size pill similar in size to that of official outcome.
Speaker Change: Once again, we found that people overwhelmingly favor taking a pill in place of an injection.
Once again, we found that people overwhelmingly favor taking a pill in place of an injection.
Thus the market research confirmed what we believed to be true people hate needles and patients prefer pills.
Speaker Change: Thus, the market research confirmed what we believe to be true. People hate needles and patients prefer pills.
Speaker Change: With that, let me now turn the call over to Mir Hashan to discuss our pre-clinical and clinical updates in more detail. Thank you, Talat, and thank you.
With that let me now turn the call over to <unk> to discuss our preclinical and clinical updates in more detail.
Thank you Paula and thank you everyone for joining us let.
Near Hashin: Let me provide some updates on two major developments, one focused on our pipeline program, RT102.
Let me provide some updates on two major developments one focused on our pipeline program at <unk>, one or <unk>.
Near Hashin: and the other on the development of a higher capacity RaniPill device, which we call RaniPill HC.
And the other on the development of Ohio capacity run device, which we call Ronnie Etsy.
Near Hashin: Let me begin with an update on the RT-102 project. RT-102 is a Rani pill capsule containing a formulation of the human parathyroid hormone analog PTH-1 to 34, which is being developed by Rani as an oral osteoanabolic therapy for osteoporosis.
Let me begin with an update on the odd one or two projects.
<unk>, one or two as the boddington capsule containing a formulation of the human parathyroid hormone analogue PTH one to 34, which is being developed by Rodney is an oral austere anabolic therapy for osteoporosis.
Near Hashin: With the goal of launching a Phase I human clinical study in early 2022, we initiated a seven-day repeat dose non-clinical GLP study in November of 2020.
With the goal of launching a phase one human clinical study in early 2020, we initiated a seven day to eat those non clinical GMP study in November of 2021.
This study was conducted in a lake canine to evaluate the safety and Tolerability of <unk>, one and two which was administered daily to these subjects for seven days.
Near Hashin: This study was conducted in awake canines to evaluate the safety and tolerability of RT-102, which was administered daily to these subjects for seven days.
Ronnie Poon capsules.
Near Hashin: tyrannical capsules were well tolerated in all animals with no clinically adverse observations.
Were well tolerated in all animals with no clinically at Moores observations noted.
Specifically there were no significant guestroom this little abnormalities associated with the old administration in both single plot dewater.
Near Hashin: Specifically, there were no significant gastrointestinal abnormalities associated with the old administration and dosing of parties.
Based on these findings we were able to meet the requirements for initiating a phase one clinical study of <unk> two.
Near Hashin: Based on these findings, we were able to meet the requirements for initiating a phase 1 clinical study of RT1.
Near Hashin: This Saison study is designed as a single-center, open-label trial evaluating the pharmacokinetic safety and tolerability of RT-1 or 2 intelligently.
This saves one study is designed as a single center open label trial evaluating the pharmacokinetics safety and Tolerability of <unk> limited.
<unk> adult women volunteers.
Near Hashin: Each subject will be administered a single dose of R-T-1 or 2 over a range of 20 to 80
Each subject will be administered a single dose of <unk> do you want to do or a range of 20 to 80 licensed reps.
Near Hashin: I'm happy to report that the study was initiated, or planned, in the third week of March, and we have already successfully dosed the first unit.
Happy to report that the study was initiated or planned in the third week of margin already successfully dosed the first human subjects.
Near Hashin: We expect to announce the top-line results of the RT-102 Phase I study in the second half.
We expect to announce the topline results of the auditing one of the phase one study in the second half of the year.
Near Hashin: Now, turning to the second major update, Rani has been working on the development of a high capacity Rani pill or Rani pill HC with the potential to deliver drug payloads of up to 20 milligrams.
Now turning to the second major update Ronnie has been working on the development of our high capacity <unk> pillow Rodney pill, It's C with the potential to deliver drug payloads of up to 20 months milligrams. We are.
Near Hashin: We are pleased to announce the successful completion of our first preclinical study in the canine model with the Roni Pilling.
I'm pleased to announce the successful completion of our first preclinical studying the canine model with <unk>.
This preclinical study utilized to Ron Tillett CD wise.
Near Hashin: This preclinical study utilized a Ronital HC device
Near Hashin: without an entry coating or chemical reactants and was inserted directly into the dejunum via a
Without an end to recording lower chemical reactions and was inserted directly into the June them via and the profitable.
Near Hashin: The device was actuated by an external pressure source.
The device was actuated by an external pressure sores to deliver approximately 18 milligrams with adalimumab for the <unk>.
Near Hashin: to deliver approximately 18 milligrams of red alluminum up to the 10.
Near Hashin: We achieved successful delivery in each of the three test subjects, which was then followed by the monitoring of systemic serum drug concentrations over a five-day period to get
We achieved success with delivery in each of the piece that subjects, which was then followed by the monitoring of systemic syndrome drug concentrations over a five day period to get a PK curve.
Near Hashin: We compared the PK levels of the 18 milligrams of Adlumumab delivered by the Ronnie Pillett.
And compared the PK levels of the 18 milligram, so abnormal nab delivered by the <unk> to peak levels of two and a half milligrams and five milligrams approximately your aluminum Nab that were delivered previously using the original Ronnie built absence.
Near Hashin: to PK levels of two and a half milligrams and five milligrams approximately at Lumamab that were delivered previously using the original Rani Bill capsules. The data
The data when normalized for bills and weight.
Near Hashin: yielded a pk curve which was proportional to the historical pk curves generated with the load.
Yielded a PK curve, which was proportional to the historical vehicles generated with the lower doses.
While we are in the early stages of development of the Ronnie village. We are excited to expand its reach to additional drug candidates that are currently delivered parents really at higher doses.
Near Hashin: While we are in the early stages of development of the Rani Piletsi, we are excited to expand its reach to additional drug candidates that are currently delivered parenterally at higher doses.
Near Hashin: And by the way, the Ronnie Pillet C shares many similarities with our existing
And by the way the run Tillotson shares many similarities with our existing run.
Now I will turn it over to slide to go over the financial results for the fourth quarter and year end 2021.
Speaker Change: Now I will turn it over to Swai to go on the financial results for the fourth quarter and year in 2021.
Why.
Thank you harsh and good afternoon, everyone.
swiide: press release we issued earlier today provide our financial results in detail so I will only provide how
The press release, we issued earlier today and provide our financial results in detail.
I will only provide highlights on this call.
Operating expenses for the fourth quarter and full year, 2021 were $13 4 million and $54 3 million compared to $5 $1 million and $17 million for the same period in 2020, respectively.
swiide: Operating expenses for the fourth quarter and full year 2021 were 13.4 million and 54.3 million compared to 5.1 million and 17 million for the same period in 2020 respectively.
Excluding stock based compensation depreciation and amortization non-GAAP operating expenses were $10 1 million for the fourth quarter.
swiide: excluding stock-based compensation, depreciation, and amortization, non-gap operating expenses were $10.1 million for the fourth quarter and $31.2 million for the full year 2021.
And $31 2 million for the full year 2021.
Turning to our balance sheet cash cash equivalent and short term investments were $117 5 million as of December 31, 2021.
swiide: Turning to our balance sheet, cash equivalents and short-term investments were 117.5 million as of December 31st, 2021.
swiide: which we believe is sufficient to fund our plan operation at least until the end of 2020.
Which we believe is sufficient to fund our planned operation.
At least until the end of 2023.
Speaker Change: With that, I will turn the call back over to Talad for closing comments.
With that I will turn the call back over to Todd for closing comments.
Talat Imran: Thank you, Savai. In closing, we are very pleased with our progress so far and look forward to maintaining our momentum in 2022. We look forward to sharing the top line results from our Phase 1 clinical trial of RT 102 in the second half of the year and to initiating our third clinical program, RT 109. We also plan to make further progress with the RonnyPill HC and are exploring a number of opportunities involving this higher payload system.
Thank you survive in closing we are very pleased with our progress so far and look forward to maintaining our momentum in 2022.
We look forward to sharing the top line results from our phase one clinical trial of <unk>, one or two in the second half of the year and to initiating our third clinical program RG 109.
We also plan to make further progress with the running till HC and are exploring a number of opportunities involving this higher payload system.
Talat Imran: We have built a world class leadership team at Ronnie and I would like to thank everyone at the company for their efforts this past year and subsequently I'd also like to thank all of our stakeholders for your continued support of Ronnie and helping us move closer to our vision of making oral biologics a reality. With that, I will now open the call up for questions operator.
We have built a world class leadership team at Ronnie and I would like to thank everyone at the company for their efforts this past year and subsequently.
I'd also like to thank all of our stakeholders for your continued support of Ronnie and helping us move closer to our vision of making oral biologic. So reality with that I will now open the call up for questions operator.
Thank you if you have a question at this time. Please press Star then one on your Touchtone telephone. If your question has been answered or you wish to remove yourself from the queue. Please press the pound key we ask that you. Please limit yourself to one question and one follow up question. Our next our first question comes from the line of Geoff Meacham with Bank of America.
Speaker Change: Thank you. If you have a question at this time, please press star then one on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key. We ask that you please limit yourself to one question and one follow-up question. Our next, our first question comes from the line of just meet them with think of America. Your line is open. Please go ahead.
Your line is open. Please go ahead.
Hey, guys. Thanks, so much for the question just had a few.
Jeff: Hey, guys, thanks so much for the question. Just had a few. When you look at the high capacity pill, are there any additional modifications beyond just the ability to scale up those? I wasn't sure if the device within the pill was changed at all to accommodate. I was just thinking whether you guys would have to go back and maybe repeat any prior safety or tolerability studies. And the second question is...
So a lot when you look at the health of the high capacity Phil are there any additional modifications beyond.
Just the ability to scale up dose I wasn't sure if.
The device within the pill was changed at all.
Comment I was just thinking whether you guys would have to go back and maybe repeat any prior safe.
Safety or Tolerability studies and the second question is.
Jeff: Is it fair to say that the HC is strategically could be the preferred product going forward, just given that, you know, a lot of approved agents are likely to be a higher dose product? Thank you very much.
Is it fair to say that the HC strategically could be the preferred product going forward just given that a lot of approved agents are likely to be.
Higher dose product. Thank you very much.
Thank you Jeff.
Speaker Change: Thank you, Jeff. And good to hear your voice. Appreciate the questions. I'll try and take them in order. The Ronnie Pill HD shares a number of commonalities with our current generation Ronnie Pill platform.
Good to hear your voice.
Appreciate the questions I'll try and take them in order.
Ronnie pill HC shares a number of commonalities with our current generation Ronny pill platform.
Speaker Change: There are obviously some modifications to increase the dose by 500%. Ultimately, it'll be packaged into the same capsule. The balloon is similar or the same, I should say. And from the perspective of the patient, the size of the capsule itself doesn't change at all.
There are obviously some modifications to increase the dose by 500% ultimately it'll be packaged into the same capsule. The balloon is similar or the same I should say and from the perspective of a patient the size of the capsule itself doesn't change at all.
Speaker Change: Having said that, given that there is a different mechanism in this device, we expect that we will be doing at least some safety and tolerability work where there may be some ability to use what we've done already would be in the biocompatibility space in areas like.
Having said that given that there is a different mechanism on this device. We expect that we will be doing some at least some safety and tolerability work, where there may be some ability to use what we've done already would be in the biocompatibility space in areas like that.
Speaker Change: In terms of where this goes relative to the current Ronnie pill platform, you're absolutely correct that this opens up a number of new opportunities and where a lot of the growth is in the biopharmaceutical space. So looking at therapeutic monoclonal antibodies,
In terms of where this goes relative to the current litle.
Our platform.
You're absolutely correct that this opens up a number of new opportunities and where a lot of the growth is on the biopharma pharmaceutical space. So looking at therapeutic monoclonal monoclonal antibodies in the immunology space or oncology and the like those are likely because of their dosing to go onto a Ronnie co HC, having said that the current.
Speaker Change: in the immunology space or oncology and the like, those are likely because of their dosing to go into a runny pill HC. Having said that, the current runny pill generation is really ideally suited for lower dose drugs, you know, the ones that are in our pipeline currently, like a PTA for osteoporosis. So there's no plan to move that over to the HC and we're fully committed to moving that forward and turning it into a commercial product once we get through the clinical phases.
Ronnie coal generation is really ideally suited for lower dose.
Drugs.
Ones that are in our pipeline currently like a PTA for osteoporosis, So theres no plan.
To move that over to the HC and we're fully committed to moving that forward and turning it into a commercial product.
As we get through the clinical phases.
Okay, great. Thank you very much.
I appreciate it thank you.
Speaker Change: Appreciate it. Thank you.
Thank you and our next question comes from the line of Annabel <unk> with Stifel. Your line is open. Please go ahead.
Speaker Change: Thank you. And our next question comes from the line of Annabelle Thamme with Stiefel. Your line is open. Please go ahead.
Annabe Ammy: Hi. Thanks for taking my question. So, you kind of touched on this before, but I was curious with the HC, are there any programs of your current programs that you think would be better suited to the high capacity, I guess,
Hi, Thanks for taking my question.
So you kind of touched on this before but I was curious with.
H C are there any programs of your current programs do you think would be better suited to the high capacity.
I guess, what you call I guess, a formulation or a mechanism like for example, maybe.
Annabe Ammy: what you call, I guess, a formulation or a mechanism. Like, for example, maybe human growth hormone where it would be administered to kids and maybe they could do, deal with like a smaller pill size or something like that. And are there any therapies
Maybe human growth hormone, where it would be administered to kids and maybe they can do.
Smaller pill size or something like that and are there any therapies that you have access to <unk>, which obviously you do that would take priority over some of the current programs that you had listed.
Annabe Ammy: that you have access to now, which obviously you do, that would take priority over some of the current programs that you had listed initially with the roundie pill. And then as a follow-up, there's, I guess,
Initially with the with.
With the Ronnie pulp and then.
As a follow up I guess kind of also touched on this but for the master file that youre going to have for the <unk> power.
Annabe Ammy: kind of also touched on this, but for the master file that you're going to have for the RANiPel, do you have to start a whole new master file for the high capacity? Thanks.
Do you have to start a whole new master file for the high capacity.
Thanks.
Yeah sure. Thank you Annabel so I think you've touched on an important point here around hh or for any any pediatric application of the Ronnie pill getting to a smaller size would let you to get to patients who are under 10 years of age so that is potentially an apt.
Annabe Ammy: So I think you touched on an important point here around HGH or for any pediatric application of the Ronnie Pill, getting to a smaller size would let you to get to patients who are under 10 years of age. So that is potentially an application where you could move to the Ronnie Pill HC, but that would require further development because the current version of the Ronnie Pill HC is the same size as the current Ronnie Pill.
<unk>, where you could move to <unk>.
But that would require further development because the current version of the Ronnie pillar <unk> is the same size as the current running Paul.
Annabe Ammy: In terms of new programs, or well just continuing on that before I move on to new programs, our Adelima map biosimilar would fit in our current Ronnie pill, but there are could be certain applications, you know, higher dose applications where it makes sense to put that into the ATC.
In terms of new programs or well just continuing on that before I move on to new programs.
Our Adeline Biosimilar would fit in our current Ronnie pill.
But there could be certain applications higher dose applications, where it makes sense to put that into the H two.
Annabe Ammy: But primarily we're looking at new programs, so that's a good segue to your second question.
But primarily we're looking at new program. So that's a good segue to your second question.
We don't have any to announce right now and we're not making any changes to our pipeline as of yet, but I think what you're intimating is that yes, because of the rounding pillar, we're going to be adding some additional programs and perhaps later in the year, we'll give some guidance on how we will strategically prioritize those we do want to show clinical.
Annabe Ammy: I think what you're intimating is that, yes, because of the Ronnie Pill HC, we're going to be adding some additional programs, and perhaps later in the year, we'll give some guidance on how we'll strategically prioritize those. We do want to show clinical validation of the Ronnie Pill HC as soon as we possibly can. Right? There's the development that will go on this year, but if we can move into the clinic, I think it's good for us and good for everybody. As far as the master files concerned, you're right, I did kind of speak to this. I think that.
The validation of the lining pillar <unk> as soon as we possibly can right. There's the development that'll go on this year, but if we can move into the clinic I think it's good for us and good for everybody.
Annabe Ammy: As far as the master files concerned, you're right, I did kind of speak to this. I think that
As far as the Master file is concerned you're right I did kind of speak to this I think that.
Annabe Ammy: Realistically, we will have to do some repeat those safety and tolerability with the Ronnie Pilla HC, where they will share commonality is that many of the components are identical. So biocompatibility and many of the other things that are going to go into verification and validation of these platforms, they'll be able to share. Okay.
Realistically, we will have to do some repeat dose safety and tolerability with the Ronnie pillar 18, where they will share commonality is that many of the components are identical.
And so biocompatibility and many of the other things that are going to go into verification and validation of these platforms will be able to share.
Okay, great, but is there going to be.
A whole new trial, though.
Annabe Ammy: No, so there'll be one master file. You can have chapters in it to cover different embodiments and also for, you know, those will have to be there for specific drugs potentially as well. Okay.
No. So there'll be one master file you can have chapters in it to cover different.
Embodiment and also for.
Those will have to be there for specific drugs potentially as well.
One five yes.
Got it.
Thank you and our next question comes from the line of Michelle Gilson with Canaccord Genuity. Your line is open. Please go ahead.
Speaker Change: Thank you. And our next question comes from the line of Michelle Gilson with Canaccord Genuity. Your line is open. Please go ahead.
Michelle Gilson: Hi, thanks for taking my question. I have one on RT-102 and then one on the high capacity pill program, too. Yes, for RT-102, you recently initiated the phase one study in healthy volunteers. Can you maybe walk us through the trial design in a bit more detail? And are there other parameters that you're planning to evaluate in that study? I guess anything else other than the different doses?
Hi, Thanks for taking my question.
I have one on one or two and then went on a hike pesky held program too.
Yes for Archie one until you recently initiated the phase one study in healthy volunteers.
Can you maybe walk us through the trial design in a bit more detail.
And are there other parameters that youre planning to evaluate in that study I guess anything else other than the different doses.
Michelle Gilson: that is, I guess, experimental within the pill. And then, you know, maybe you can help us understand what a good result is for that study. You know, what can we learn from the PK profile? And, you know, it's been very difficult translating PK data for some other PK programs.
That is I guess experimental within the pill.
Then maybe you can help us understand what a good result is for that study.
What can we learn from the PK profile.
And it's been very difficult translating PK data for some other PTH programs.
Michelle Gilson: I guess they use alternative dosing routes that aren't sub two in terms of the read through to, you know, biomarker or BMP results. So, you know, maybe you can address why, you know, you can get why we should be comfortable with the PK profile, I guess, that you guys show for RG one or two.
Do you guys think is use alternative dosing Hudson Orange sub Q.
In terms of the read through.
Two biomarker or PMT results so.
Maybe you can address why.
You can get why we should be comfortable with the PK profile gas.
Guys show for Archie one or two.
Speaker Change: Sure. Should I answer that and then we'll go to the HC question?
Sure.
Should I answer that and then we'll go to the HC question.
Yeah that sounds good.
Speaker Change: Yeah, that's just good. Okay, fair enough. So hi, Michelle, by the way. Thank you for the question. Happy to go into some details on our RT 102 phase one. It is a single dose study and healthy volunteers as you mentioned. We're doing a 20 microgram dose, which is the commercial corteo dose. We're also doing an 80 microgram, which is where a volaparitide is clinically dose.
Okay fair enough.
So hi, Michelle by the way.
Thank you for the question happy.
Happy to go into some details on our Archie one or two phase one.
It is a single dose study in healthy volunteers, we mentioned were doing a 20 microgram dose, which is the commercial curtail dose. We're also doing an 80 microgram, which is where a volatile abaloparatide is clinically dose and we're going to do an intermediate dose as well you are correct that you need to look at Biomarkers.
Speaker Change: And we're going to do an intermediate dose as well. You are correct that you need to look at biomarkers, ultimately, and this area has had a number of failures, both in oral formulations and with the patch, most recently. The difference in what Ronnie is doing to what everyone else has attempted is this is an injection.
<unk> and this area has had a number of failures.
Both in the oral formulations and with the patch most recently.
The difference in what Ronnie is doing to what everyone else has attempted this isn't injection, it's an intradermal injection to be sure, but it's ultimately an injection. So the peak and the trough as we've shown pre clinically is very similar to what you would expect to see subcutaneously you are correct, though that the PV part of this is an important part of that.
Speaker Change: It's an intradruginal injection, to be sure, but it's ultimately an injection. So the peak and the trough, as we've shown preclinically, is very similar to what you'd expect to see subcutaneously. You are correct, though, that the PD part of this is an important part of that.
That story and.
Speaker Change: story and nothing to report yet but hopefully we'll have some additional details to share later this year when we when we share the leadout on the phase one that'll give some comfort that this is going to produce similar results to what you'd expect from a subcutaneous delivery of terrapair.
Nothing to report yet, but hopefully we'll have some additional details to share later this year when we when we share the readout on the phase one that'll give some comfort that this is going to produce similar results to what you'd expect from a subcutaneous delivery of terror paradigm.
Oh, Thank you and in.
Speaker Change: Thank you, and in terms of, I guess, for the RonnyPillHC.
In terms of I guess for the Ronnie till each C.
Speaker Change: I know you the first initial proof of concept was done with the placement of the Ronnie pill via laparotomy in June .
Thank you.
First initial proof of concept was done with the placement of the Ronnie till the latter Rodney.
Thank you.
Speaker Change: You know, should we expect, I guess, the next steps to be very similar to, you know, what you.
Should we expect I guess, the next steps to be very similar to what you do.
Speaker Change: did for the original Ronnie pill or I guess what are the next steps for evaluating the HC pill and you know, at what point do you get comfortable bringing into the clinic? I know you're looking forward to bringing this into people.
For the original Ronnie pill, or what I guess, what are the next steps for evaluating the Ht pill and.
At what point do you get comfortable bring into the clinic I know youre looking forward to bringing us into people.
Well. Thank you for that question and I'm glad that folks are excited enough.
Speaker Change: Well, thank you for that question, and I'm glad that folks are excited enough that, you know, two months or a month after announcing it, everyone's asking me, when are we getting it into the clinic. I think it is an important development for the company. You're correct. We did a placement by a laparotomy and it was externally powered. That was in order to visualize the delivery. We did this with the first Ronnie pill platform as well.
Two months for months after announcing it everyone's asking me when are we getting it into the clinic I think it is an important development for the company.
Youre correct, we did a placement biolab merotomy and it was externally powered.
That was an order to visualize the delivery we did this with the first one he told platform as well and the next step is.
Speaker Change: And the next step is to take a fully packaged product.
How it would take a fully packaged product and put it in Biolab Merotomy again watch it unfold watch it deliver and hopefully get good reliable results in terms of PK and from there. The final step is in the oral administration and await canine we'll get through those knock on wood hopefully this year that's the plan.
Speaker Change: and put it in via laparotomy again, watch it unfold, watch it deliver, and hopefully get good reliable results in terms of PK. And from there, the final step is in the oral administration and awake canine.
Speaker Change: We'll get through those knock on wood hopefully this year. That's the the plan and then in parallel.
And then in parallel we're doing.
Speaker Change: candidates election, both, you know, for our pipeline and talking to some potential partners.
Our candidate selection.
Both for our pipeline and in talking to some potential partners.
Speaker Change: uh and uh with the goal of of getting that into the clinic as soon as reasonably possible. I think development is always hard to predict uh down to the day right or even perhaps the month but a lot of the heavy lifting has been completed which is why we were comfortable announcing it.
And.
With the goal of getting that into the clinic as soon as reasonably possible I think development is always hard to predict.
Down to the day rate or even perhaps the month, but a lot of the heavy lifting has been completed which was why we were comfortable announcing that getting a mechanism that could deliver 500 per cent plus or more that was the really hard part and we've been able to show that already.
Speaker Change: Getting a mechanism that could deliver 500% plus or more. That was the really hard part and we've been able to show that already.
Alright.
Speaker Change: All right. Well, thank you for taking my question and congrats on your first earnings call as a public company.
Thank you for taking my question and congrats on your first.
Earnings call as a public company.
Thank you so much vishal.
Thank you and our next question comes from the line of Brandon Folkes with Cantor Fitzgerald. Your line is open. Please go ahead.
Speaker Change: Thank you. And our next question comes from the line of Brandon Folkes with Cantor Fitzgerald. Your line is open. Please go ahead.
Brandnon: Hi, thanks for taking my questions and congratulations on all the success. So maybe just following along a similar line, you know, as we look at longer term, is the rainy pool HC something you expect to pursue in parallel with the original rainy pool? And I mean that from the aspect of understanding what you have communicated today, you know, that's
Hi, Thanks for taking my questions and congratulations on all the success and so maybe just following along a similar line you know as you look out longer term is there any HC something you expect to pursue in parallel with the original Reni pool, and I mean that from the aspect of understanding what Chad.
Communicated today he did that.
Brandnon: You're still committed to the second phase one study, getting RT on it to market it. When you think about new indications going forward, should we think about those coming through in both the RANiPOL and the RANiPOL HC or just given the potential, you know, multi-contemplates, maybe reallocating resources to the RANiPOL HC?
You're still committed to.
Second phase one study getting arty you wanted to to market.
What do you think about new.
Indications going forward should we think about those coming through in both the radical Antiradical H C or just given the potential.
Machu contemplates.
Maybe reallocating resources to the radical H C.
Speaker Change: And then I'll just ask my second question because it probably
And then I'll just ask my second question, because I probably add.
Speaker Change: is haunted in the same vein. I have a good memory of your hand and you can go for it, for sure. Well, can you just talk about the studies contemplated in the statement of the cash runway through the end of 2023? Just given that's a pretty solid cash runway, any potential to pull programs forward there, especially in the HD programs or is sort of development still progressing there where that's really the limiting factor versus cash? Thank you.
Answering the same violent good remember when you talk about that.
For sure.
Can you just talk about the study contemplated in the statements of the cash runway through the end of 2023.
Given that's a pretty solid cash runway.
Potential to put programs forward there, especially in the HD program. So is sort of development still progressing day, where that's really the limiting factor versus cash. Thank you.
Sure sure. So in short I think you will see developments with both platforms in parallel we still get considerable inbound from pharma companies that want to use our current Ronnie pill generation for some really interesting next generation applications within the biotech space. So there there are places I won't speak to.
Speaker Change: So in short, I think you will see developments with both platforms in parallel. We still get considerable inbound from pharma companies that want to use our current RonnyPill generation for some really interesting next generation applications within the biotech space. So there are places I won't speak to right now that we could go that are really ideally suited. The other thing that we're doing with the current generation RonnyPill platform is a sustained release version.
Right now that we could go that are really ideally suited the other thing that we're doing with the current generation Ronnie co platform is a sustained release.
Version and that would take certain peptides and make them deliver over several days instead of immediate and immediate release that opens up our Artemis <unk> PTH for hyperparathyroidism for other indications as well, they're very interesting applications that can be used there.
Speaker Change: And that would take certain peptides and make them deliver over several days instead of immediate and immediate release.
Speaker Change: That opens up, you know, our RT 110 PTH for hyperparathyroidism for other indications as well. They're very interesting applications that can be used there. Having said that, of course, the Ronny Pillage,
Having said that of course, the Ronnie pill H C <unk>.
Speaker Change: opens up virtually all, many I'll say, of the monoclonal antibodies that are currently on the market, virtually all in the inflammatory space.
Opens up virtually all many I'll say of the monoclonal antibodies that are currently on the market virtually all in the inflammatory space and many in areas like oncology or rare disease. So clearly there are a number of opportunities for pickup now where does that fit in terms of our budget.
Speaker Change: and many in areas like oncology or rare disease.
Speaker Change: So clearly there are a number of opportunities for pickup. Now, where does that fit in terms of our budget, our budget contemplated running to phase one or repeat those ID and two phase ones in 2023. So to this year, the repeat those study and to next year.
Our budget contemplated running two phase ones, a repeat dose IV in two phase ones in 2023. So two this year the repeat dose study and two next year.
Speaker Change: If we're going to add to that, we will obviously need to look at bringing on additional resources or doing that in partnership.
If we're going to add to that we will obviously need to look at bringing on additional resources or doing that in partnership.
Speaker Change: But nothing to report right now. I think we'll figure out where that program is going. The RaniPoHC platform, I should say, is going over the course of this year. And when we're ready to make some additions or alterations or move things up, we'll definitely let you know.
But nothing to report right now I think we'll figure out where that that program is going to art Ronny core HCI platform I should say is going.
Over the course of this year.
And when we're ready to make some additions or alterations or move things up we'll definitely let you know.
Great. Thank you very much.
Yeah of course.
Speaker Change: Thank you. And again, ladies and gentlemen, if you have a question at this time, please press star then 1. Our next question comes from the line of hassle with BTIG. Your line is open. Please go ahead.
Thank you and again, ladies and gentlemen, if you have a question at this time. Please press Star then one our next question comes from the line of Frank Castle Peak.
<unk>. Your line is open. Please go ahead.
Speaker Change: Yeah, it's Bert Hayes, but thank you for taking the question. Congrats on the progress over the past months and years. And just strategic one, you've touched on a lot of these specifics, but strategic one,
Yes, Bert Hazel. Thank you for taking the question congrats on the progress.
The months or years, and just strategic one.
So on a lot of the specifics that strategic one with.
Burt Hayes: With regard to the portfolio, let's call it, both with HC and with the Ronnie Pill.
Regard to the the portfolio, let's call it.
Both with HCN with.
Ronnie pill.
Burt Hayes: The regular Ronnie Pillows call it. Just how are you thinking about how much you can actually take yourself versus partnerships and.
The regular Ronnie till let's call it.
Just how are you thinking about how much you can actually take yourself versus partnerships.
Burt Hayes: Is there a sense of how the strategic are being contemplated internally? Can you give us any sense for the potential for partnerships as you contemplate, again, both programs with AC as well as Ronnie Pill regular?
Is there is there a <unk>.
Sense of.
How old is strategic.
Or are being contemplated internally can you give us any sense for for the potential for partnerships as you contemplate again, both programs with AC as well as Ronnie <unk> regular.
Sure.
<unk>.
Burt Hayes: So as far as what we're thinking about doing with our current pipeline and the expansion of it, I think that realistically, there may be some small additions, one or two programs on the
So as far as what we're thinking about doing with our.
Current pipeline and the expansion of it I think that realistically there may be some small additions one or two programs on the.
Regular I call it the <unk> could be the current generation writing platform radical platform, but then the as far as the agency is concerned we will absolutely add.
An additional program as we get through our oral preclinical testing I think that this is there is potential in either case for those to be partnered programs as I mentioned before we are getting interest in and using the platform to deliver both lifecycle management kinds of products and novel novel compounds.
I think this just remains to be seen we can't do everything I think when we talk about the potential opportunities for expansion there very large given the capabilities of the Ronnie pill platforms.
Burt Hayes: I think this just remains to be seen we can't do everything. I think when we talk about the potential opportunities for expansion. They're very large given the capabilities of the Ronnie pill platform.
Burt Hayes: But we, as you said perfectly, we have to be very strategic in what we go after, so we'll take into account the clinical trial burden, the cost of running those trials, the revenue potential of those particular products, and the burden for patients of the injectable regimen as it currently is, and the opportunity potentially for expansion of access that comes with an oral formulation.
But we as we said perfectly we have to be very strategic in what we go after so we will take into account the.
Clinical trial burden the cost of running those trials.
The revenue potential of those particular products and the burden for patients of the injectable regimen as it currently is and the opportunity potentially for for expansion of access that comes with an oral formulation. So those are the things that are going into our thinking and like I said I think we will have more color later in the year.
Burt Hayes: So those are the things that are going into our thinking. And like I said, I think we'll have more color later.
Speaker Change: Okay, great. Just one other quick follow-up. Maybe you mentioned it, maybe I missed it. In terms of timing with the master file of progress or let's call it a result from the master file, is there any particular timing that you've indicated there?
Okay, Great and just one other quick follow up maybe you mentioned and maybe I missed it but.
In terms of timing with the master file or progress or or let's call. A result from the master file is there any any particular timing that you're that you've indicated there.
Speaker Change: No, we haven't. We're on track with our plan.
No, we havent, where we're on track.
With with our plan so.
Speaker Change: So we have to run a pretty significant
We have to run a pretty significant.
Speaker Change: GLP, or I should say IDE enabling GLP study, and we're gearing up for that. That takes a lot of work to get that ready to go, and it's a two-month study. And then from there, we'll submit the IDE and get into
G L P.
I should say I D E, enabling G. L. P study.
And we're gearing up for that that takes a lot of work to get that ready to go and it's a two months study.
And then from there we'll submit the IDE he can get into.
Speaker Change: into actually running the the the study itself and having that data go into a master file we may have an update Sooner rather than later. We'll share that when when it when it happens terrific. Thank you
And so we're actually running the study itself and having that data onto our master file we may have an update sooner rather than later, we'll share that when when it when it happens.
Terrific. Thanks, Congrats again.
Thank you so much.
Speaker Change: Thank you, and I'm showing no further questions at this time, and I would like to turn the conference back over to Tlat for any further remarks.
Thank you and I'm showing no further questions at this time I would like to turn the conference back over to Taylor for any further remarks.
Lat: Well, thank you operator. This concludes our fourth quarter and full year 2021 conference call. Thank you again everyone for joining us this afternoon.
Well. Thank you operator, this concludes our fourth quarter and full year 2021 conference call. Thank.
Thank you again, everyone for joining us this afternoon.
This concludes today's conference call. Thank you for participating you may now disconnect everyone have a great day.
Lat: This concludes today's conference call. Thank you for participating. You may now disconnect. Everyone, have a great day.
Yeah.
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Okay.
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