Entera Bio Ltd.

Q1 2021 Earnings Conference Call


spk_0: the morning and welcome to and tears by a conference call to discuss the financial an operating results for the year ended december thirty first twenty twenty at this time ah participants on listen only mode after the speakers presentation they'll be a question and answer session to ask the question during the session you depressed are one on your telephone if you require any further assistance please preston zero hour no like to turn the call over to john the per view a space the a full of in please go ahead
spk_1: thank you and welcome to the car journey me on today's call or spare janice our ceo
spk_0: art center or the ammo and felt shorts are present of our date a press release announcing interest financial and operating results for the year ended december thirty first twenty twenty was issued earlier today
spk_1: those of you who have not yet seen it it is an album the investor section of our website www dot and terrible dot com
spk_0: on our call this morning your share your business update and when you financial results which will be fall by question and answer session before we begin our prepared remarks i would like to remind you that very statement to make during this call that the company's future results of operations and financial position our interpretation and term data from the ongoing case to clinical trial of the be six one three including a biomarker data released in the first quarter twenty twenty one the expected timing of data redoubts from the ongoing cease to clinical trial eighty six one three our business strategy and plans an object is far future operations or consider forward looking statements within the meaning of the federal securities laws are forward looking statements are based upon current expectations that valve risk changes and circumstances assumptions and uncertainties specifically developments related to
spk_1: the coven eighteen pandemic continue to evolve and the extent to which the pandemic one packers in the future will depend on the duration and magnitude of such impact and on numerous factors that we may not be able to accurately predict these risks are described marshaling rcc towns are available on the fcc is edgar system and on her website we encourage all investors to read our assisting filings all the information we provide in this campus cause provide only as of today and we undertake no obligation to update any forward looking statements you make on this call on account of new information future events were otherwise finally please be advised that today's call is being recorded and webcast are announcer and the
spk_0: call of to spare jumps
spk_2: thank you john and thanks everyone for joining the or this morning i joined and tear on january twenty twenty one based on the company's validated technology platform that enables the all delivery of promoting therapeutics and a talented and dedicated team in the short time since i joined we've hit several key milestones are generated value for our shareholders and further confirmed my confidence in both our team technology and believe that we have the ability to create more value we have data showing that our platform works on eight molecules are board characteristics and size i believe these data will support business of up and discussions and generate future value shoot to such a dick collaborations and partnerships in addition the recent rise and our share price has enabled us to strengthen our balance sheet and i'm pleased to say that we believe our current cash resources or fun the company into the second quarter twenty twenty two the significant potential of interest ecology platform to give patients a much needed arla turn into to treatments currently delivered via injection is supported by data from multiple can i call trials including the recently announced positive three month loan biomarker data from the ongoing face to trick clinical trial on t v six one three in or shapiro suspicions and the data from a face to a study of he be six twelve in hypothyroidism patients that was recently published in the journal of been real research but significant momentum coming out of twenty twenty we focus on leveraging the platform technology to create additional value either to the planetary products such as a be six one three and levy six one to the can be developed either by and tara alone or in collaboration with a partner while playing our technology to another companies compounds such as what we're doing and our collaboration with engine each of these options potentially enables multiple pottering opportunities that can generate funding new slow and allow the company to share in the future value of multiple dearest assets while i infallible go into great detail on the clinical programs and platform i would like to take a few minutes to provide an overview of the programs and some of our recent accomplishments first on e b six one three hour early delivered human parathyroid hormone one to thirty four o p h position to be the first oral bone building or action abolish treatment for each of those his patients and we recently announced that the phase two trial in women without your bra oh says or loan low bone mass met it's primary endpoint a complete three months results from the trial showed a significant increase in the p one and p biomarker in the two point five milligram dogs group after three months of treatment with a p that you have less and point zero four compared to placebo p one and p as a biomarker that indicates a rate of new bone formation as or a mind that this face to clinical trial is a double blind to dose ranging placebo controlled study and post menopausal female subjects but also process or know rob lowe bone mineral density old b m d this trial is being conducted at for leading medical centers in israel has completed the enrollment other one hundred and sixty one subjects the data comes on the heels of a number of other important milestones and twenty twenty for the be six one three that i've been program in august twenty twenty we announced the six month interim bomb bone mineral density data from the first fifty percent of patients in this trial the data indicated he be six one three has a meaningful and positive impact on lumbar spine bmd in a dose dependent manner or that point five to one point five milligram dose ranged and supported the idea decision to had a two point five milligram dose these data were important because increases in lumbar spine be empty have been associated with factor reduction in patients treated with something changes ph and a change in lumbar spine bmd is now an accepted and point for regulatory approval of novel formulations of drugs like human piquet want to thirty four that have been shown to reduce the risk of fracture importantly the bnp they are reported to date to not into data from any subjects the two point five milligram treatment on we expect report the final results from this trial including the six months be data in the second quarter twenty twenty one in addition in the fourth quarter of twenty twenty were announced the completion of the enrollment in the trial and the acceptance by the ft eight of the us i indeed for eighty six one three the completion of enrollment as a major milestone given the extraordinary challenges related to the car with pandemic and along with the eye and acceptance an important step forward to moving the program towards a pivotal face weeks and uncle trial assuming the continue to see positive bmd data from the be six one three phase two trial and subject to a successful post and the face to meeting with the us food and drug administration five game we believe a phase three trial could began and twenty twenty two we believe the value proposition of the be six one three is very strong to to the fact that only a small percentage of patients we also process actually treated with subcutaneous bgh or other injected been building drugs to to cost convenience and compliance challenges the my greece's we conducted a report last year points to significant unmet need for an art therapy the bone bone in a multi billion dollar will also us as market trying to be six one to for hype of parathyroid isn't data from a two thousand and fifteen study recently published in the journal of bone marrow research o j b m are fallible provide additional details but in summary we'd be sex one to when added to standard of care letters to disagree significant decline and supplemental calcium usage a key and point in the have hypothyroidism at trials we focus on optimizing the formulation that we would intend to move forward we have also continue to support preclinical like and our collaboration with amgen are pleased with the progress made to date and look forward to continuing to support the collaboration in accordance with amgen project plan and objectives from a business of oven perspective we have increased our efforts to leverage our technology platform and have an ongoing dialogue with several companies are interested in exploring the use of oil delivery platform that their injectable product candidates will focus on moving these conversations into form agreements operationally we have continued to carefully monitor out spencer's you judge judiciously raised cash through the use of i t and program with category i'm pleased to say that our current cash on hand the sufficient to support our planned operations into the second quarter of twenty twenty two
spk_3: i would like to turn the call overtook doctor odds and torah our chief medical officer to discuss the phase two trial of any be six one three
spk_0: thanks girl
spk_3: has reminder the phase two trial was designed to evaluate the impact of different doses of eighty six thirteen and serum fire barkers a bone activity after three and six months of treatment and on bmd after six months or treatment
spk_0: from biomarkers evaluated include keep mine in p r c o coulson and city x he volunteers a biomarker that indicates the rate of new bone formation demography poi anti osu keelson is a biomarker for bone formation by us a blasts the cells that build new about city acts as a biomarker the indicates the rate of bone resort shop by asked the a class the cells remove all down
spk_3: an osu anabolic or bone building a fact is based on the difference and bone formation
spk_0: and bone researcher
spk_1: an increase in t y m t roster coulson for example associated with a smaller increase or even a decrease in see tx usually indicates an increase in bone mass
spk_0: in the phase two trial subjects were initially randomized receive either a placebo or one of three doses of he be six thirteen point five one point zero and one point five milligrams after the and he evaluation of the and from three months biomarker data in the first aid it
spk_4: subjects randomized we amended the protocol to discontinue additional roman and the zero point five and one milligram terrorist groups and at a new hire two point five milligram this group with a final to sixty subjects randomized to receive either placebo one point five or two point five million
spk_0: graham of eighty six thirteen subject follow up in the face to trial has remained strong with approximately one hundred and fifteen subjects having already completed their six months visits based on our recent analysis of the complete three months bone biomarker data study make medication eighty six thirteen or placebo was generally well tolerated through the treatment period common adverse events resemble those known to be associated with terry care tied by subcutaneous injection there are no adverse events that were severe and intensity and any treatment group and no serious drug related adverse events a complete safety evaluation of the full on blind date of will be conducted with the for six months data analysis expected and a second quarter of twenty twenty one finally demographics of subjects and his trial are generally consistent with other previously supported osteoporosis trials and postmenopausal women as girl mentioned earlier the trial met it's primary endpoint with he two point five milligram dose group showing significant increase in the p one in t biomarker after three months of treatment that p value was lost and zero point zero four as compared to placebo similar to the increase in t one and t a significant increase in austria coulson another phone from his remark her was also observed in the two point five milligram group after three months or that he values less than zero point zero one in addition a significant decrease in city ex was observed after three months or treatment te vi a resource and zero point zero one five the decrease and city acts taken together with the increase and he wanted prc coulson would indicate a potential positive impact on the it
spk_4: we look forward to sharing the final bmd data from the trial and the second quarter of twenty twenty one
spk_0: as a reminder we reported and from the md data limited to the first a subjects randomized and the in the study and it's third quarter of twenty twenty based on the and from six month bmd data eighty six thirteen generate j mean placebo adjusted increase and lumbar spine dmd of two point one five percent that he value was zero point zero eight for supporting subjects and the one point five milligram freeman arm as compare to the sixteen subjects and placebo on the placebo adjusted increase with comprise the mean in the increase of one point four four percent and the one point five milligrams human on compared to a mean decrease of his euro point seven one percent and the placebo on additional analysis of bmd changes in all a be six thirteen treatment groups showed a significant dose dependent trend in the percentage increase and lumbar spine vm day
spk_4: increases in maintenance and the in the are widely accepted by clinicians throughout the world as indicators of an overall improvement have osteoporosis during parents are hormone treatment
spk_0: importantly the previously reported dmd data did not include any subjects from the two point five milligram those group which was more recently added the change of on find the md is the recommended phase three study efficacy and point for a novel or all human pity eight hundred thirty four formulation and tended to treat osteoporosis and developed using the f t a's five oh five be to regulatory pathway a fracture in point trial is not required because subcutaneous p t h one to thirty four generically name terry terrified for injection has been shown to reduce the risk of fracture as expected and for system that published data from studies of subcutaneous terry para tide and analysis of bmd data of the total femur ephemeral neck did not show a significant effect or treatment with tv six thirteen
spk_5: i will now turn over the call to doctor thought shorts our president of our d to share some updates with you on e b six twelve and are ams and program thanks very much to good morning everyone i would like to provide you with a brief update any be six twelve hour or really delivered pt age for the treatment of the orphaned defeat hyperthyroidism for hypo pt we're developing a be six twelve to be used as a first line hormone therapy that would be applicable to patients with different levels that disease severity are excited by the recent publication of her face to data in jp are a leading peer reviewed journal
spk_6: there are significant unmet need and figment of hypothyroidism and we believe and or a p t h would improve compliance as well as therapeutic impact and they offer patients with i prepare attire it does have a much needed alternative to the currently have proved p t th replacement therapy options which art minister it is via it
spk_1: daily injections
spk_5: as a reminder our goal is to treat patients at his sentence while normalizing serum and your calcium levels to minimize the adverse effects of long term tells him supplementation and act of vitamin d it the recently published data demonstrated the safety and tolerability of eighty six twelve administered four times daily for sixteen weeks patients with hypothyroidism in the face to a trial importantly the study achieved it's primary and secondary and point including a reduction and calcium supplements reductions and zero phosphate maintenance of alvin when adjusted term calcium within the reference range and and improvement in quality of life
spk_7: civic results from the trial included a significant reduction of forty two percent with a p value of point zero zero zero one a baseline in medium calcium suffer purchase
spk_5: it also included maintenance of medium calcium levels in the bloodstream above the lower target for hyperthyroidism cases which is approximately seven point five milligrams predictably that route the study and it was also a rapid decline of twenty three percent that the p value of point zero zero zero three in medium serum phosphate lovers and levels two hours following the first steps that was maintained within the normal range but duration of the study
spk_6: and a notable median decrease of twenty one percent or point of it to a key value point of seven twenty four hour urinary calcium excretion between first and last week the day
spk_5: in this study patients for try to get up to a maximum of twelve eighty six twelve point seven five milligram tablet the date for a total use of nine milligram by the investigative according to each subject calcium levels and supplement treatment regimen of the nineteen and roll patients seventeen completed trial of which fifteen were for protocol there were no drug related serious adverse events and most of the adverse events were not considered studied art related at all we are continuing to conduct additional formulation work on e b six twelve including the authentic the case and of enhancements that we are evaluating in preclinical models in addition we are also working in the design of the next clinical trial for be six twelve which we expect to initiate in two thousand and forty two our collaboration with amgen for the development of an oral anti inflammatory region has continued and we're pleased with the progress we have me to date we are continuing to support the collaboration an amd has completed several fleet preclinical studies that have included the evaluation of different formulations of their drugs with our platform we also continue to focus on the development of our platform as relates to the evaluation of new eighty eight after pharmaceutical ingredients in believe that these efforts have the potential to generate value to either additional validation of our technology platform and or through potential business development activity as an example recently announced a new research program for oil luke them like peptide to or all glp to this is an analog and based on our technology platform we have been able to develop it all formulation for it jill p to a peptide produced in the intestine he on the central nervous system here the brain stem and hypothalamus is known to enhance festival absorption the civically the increased absorption of nutrients
spk_6: only glp to analog currently on the market
spk_5: had a glue type was approved in two thousand and twelve as they once did injection for the treatment of short thousand from us and europe registering global sales of five hundred and seventy four million dollars in two thousand and ninety in preclinical models and terrorists or formulation of glp to analog as shown a comparable pharmacokinetic profile since of detainees injection we look forward to sharing additional data on or glp to analog over the coming months
spk_8: i'll now turned the ball over to john libor are you a cfl to cover the financial results
spk_0: thank you fellas
spk_1: revenues for the year ended december thirty first twenty twenty were three hundred and sixty five thousand dollars as compared to two hundred and thirty six thousand dollars and twenty nineteen with revenues in both ears attributable to the aren't he services provided the engine the cost of have used for the or and december thirty first twenty twenty and twenty nineteen we two hundred know one thousand and two hundred and ten thousand respectively and were comprised of salaries and related expenses in connection with learn these services provided to amgen
spk_0: total operating expenses for the year ended december thirty first twenty twenty one eleven point three million and including six point four million and research and development expenses and four point nine million in general and administrative expenses research and develop an expense for the or ended december thirty first twenty twenty consisted primarily headcount related costs external costs related to the conduct of eg six thirteen face to clinical trial and consulting spencer's emcees related to the preparation of the be six thirteen i in the application general and administrative expense for the your ended december thirty first twenty twenty was primarily neither salary and related expenses including sharpies compensation professional fees the you no insurance expense and legal fees
spk_1: the comprehensive loss was ten million or fifty five cents ordinary share diluted for the year ended december thirty first twenty twenty compared to ten point eight million or eighty nine cents for nary share basic and eluded for the or ended december thirty first twenty nineteen as a reference point we currently have a and twenty four million prize omer shares outstanding and thirty two million fully deluded shares outstanding
spk_0: at december thirty first twenty twenty and terror had cash and cash equivalents of the point six million and in our twentieth that we intend to fall today you all for a proxy fifteen point four million in cash and cash equivalents as march sixteenth me twenty based on current operating plants expect our twenty twenty one operating loss the to the between eleven and twelve million dollars this is of course subject to the expected timing of product development programs could he be six one three and subject to any me impact of coven nineteen on our operations as a result we currently believe our cast position of or
spk_2: operations into the second quarter of twenty twenty two i will now trying to call back to spiro for concluding remarks before we go to queue and eight thanks john we're excited about the recently reported data for he be six one three and a six one too we continue to believe that the market opportunity and each of these areas is substantial the recently released three month bone biomarker results demonstrate a clear dose response using our platform to deliver ph orally this is great clinical validation in addition the strength of the platform and i'll balance sheet have enabled us to generate data for several additional molecules such as grp to we have data showing that up and to a platform works on molecules abroad characteristics and size
spk_0: i believe these data will support business development discussions and generate future value to city to cut aberrations and partnerships ladies and gentlemen have crush nor communist the time please press the star than the one key on your touched on telephone if your question has been answered he was to move yourself from the queue please just a coffee
spk_9: a first question comes from jason mccarthy with max and group
spk_10: scared how are you take your taking the classic could you talk just a little bit about ah
spk_9: the importance of the ratio of p y n p and seats yeah and how that changes and more specifically how that compares to what happens with forte l prolia or any other hamlet or any other
spk_11: the fracture preventing ask the a drug that out there because those ratios are critical
spk_2: insightful to thanks yeah jason yeah i know ah yeah i'll just give him a very high level and then our direct dialogue and up and then not there to give more their their color respectively yes and just from a from very high level a p one and p increase correlates with a increase in the lab bone mineral density also an animal or relates to the anabolic all fat was see tx had that translates far in prison gtx to i was option now bone so you really want to be i have to have an anabolic affects wanna have high a p one and p and our you have no actually reducing our he tx and so the fact that we saw i had our high dose group that you can find a random those he saw significant increases in pune and p and take actually significant reduction in the city axes that kind of the the i either the ideal profile that you would like to get for a long lost your anabolic effect and then that would translate to increases in bone mineral ladder and city
spk_10: an end up but let me have that philip that provide the on some additional lack so one color on on on the sub that let's have a very important question thank you just yet and philip it ran a on a guy up the are you as part of that question can you also comment i believe or how ban
spk_4: cgx actually goes up
spk_12: maybe get up a little bit of that as well after they get
spk_4: sure sure how thanks jason i'm yes you're correct actually allow with for taylor or is subcutaneous injected p t h one to thirty four mtx goes a very very significantly am a far more than any of the other drugs mentioned like a bellow kara tight out or prolia
spk_7: or album or some of the other anabolic agents that are out there it specifically a vanity
spk_5: and it's interesting that although were using the same at the pharmaceutical grade and eighty i as for tail up because our pk profile is somewhat different it behaves more similar to of l a parrot tide and also to the keep to each patch specifically out of those drugs which have a stronger
spk_7: your impact and empty it can be seen as many of the papers that have been published though they're increasing dmv with actually greater than that was what was observed with for tail
spk_4: come they both have a much smaller increase in t one and feet which is the built at about building marker at compare for tail yet because they have a much smaller increase in t tx they have more of an impact on a bone mineral density and bone building in our case where almost more similar even it too roma so some aba a vanity in the sense that not only do we have a much lower increases he acts that we actually have a decrease in yeah
spk_13: as well as arise and key within though of both of those factors combined
spk_10: make us believe that it will have we could have very promising results in terms of bone mineral density and that we're very excited about that and then fill our spirits the eat remind everybody at that the clinical pathway to get to potential approval i will i be to had of a one and done trial are you don't need fracture which is a huge differentiator for and harry is to fix my bomb or that the and it's part game
spk_4: where are your comments to that point or can you talk a little bit about a what the expectation that be and be at six months you think
spk_2: would be clinically meaningful enough to get
spk_14: fix fall approved
spk_2: for per metric from our prior to meeting go go at first place no no thanks isn't guess i'm just for his high level on the regular the five oh five be to read regulatory path because are that that's such an important aspect of our about it up and program were under the five of i'd be too we are we don't have to run not said to face three on studies will to which is typical and at the clinical development program we can conduct a single pivotal study and show off and comparison studied to for town so read a single man a little study and
spk_4: the the a has accepted bone mineral density as less cynical and and point as sunlight we don't yeah absolutely you do not need of reduction as a or one and point so those studies ah the suit require fuel a lot your patience and that the time that the time of those studies as significantly yeah
spk_7: known them and done some depth enough set up and an odd to him with of provide yeah color on the regulatory pass and pm
spk_6: the in the and more high taxation for that the dmv and point
spk_7: i'll just add to what you're up there said out i just added him a break i know that of fact that we had in our pre i and the meeting that the at the a gave it a very explicit guidance in writing
spk_4: up at that is doing a one pivotal faith three study with a be empty and point a an inferiority study up there with for tail
spk_9: it would be sufficient for approval and as they give us a very generous march and of non inferiority out which was very helpful and it just to give you an idea of what that that he will likely look like of that study it's it's likely to be a twelve month study our with somewhere between six hundred and eight hundred dab of patience and into ah arms each arm would have about four hundred patients are so one for tail i have one thirty am i gonna like i think that his dad our to get the tremendous amount of experience with clinical trials in nasty process that could add a little bit more clarity perhaps to up a what that type of fraud might look like in and like patients are for the and point there would be necessary in order for us to achieve a poop full
spk_15: okay that fucking be i briefly be a fellow skin just gonna compare and contrast to a high level of the glp one vs glbt market i know that allah
spk_2: grp to got axes what almost six hundred million and was and twenty ninth you haven't checked through this year and then we look at on the glp once i watch the that a little bit more challenging and nine meters as their ah with an injection ah for glp one but the a that market cap it all up to the a near four hundred million i think just based on that based on that one program in particular that you compare and contrast the opportunities here maybe were that valuation gap between and these other place it and they need to close as you can move forward no thanks thanks another avenue and dumb question just so we're in terms of that our that one the data that we've generated than that your why we picked up to some glp to be picked jumpy to because we are when looking at the physical chemical characteristics of glp to and and dad not as of how platform works there was sort of that we had a very highly i had a high likelihood of success would would see very good pk enough in the animal models and we conducted the moon tk models and yeah and and showed that we can deliver shelby to our leave with a very nice pk profile some been very high achieving high blood blood levels all that that services is again what are some of the money is shown that the an oral that glp to and so while they're young and and the often than we currently approved glp to is an open their drug itself
spk_9: an indication the i didn't i just ended with small town current annual sales i think i expected to be along six hundred million for sure bowel syndrome
spk_3: and ah but don't use of the glp twos awful to also three rolls and other potential lead diseases so we see potential opportunity actually not the to even indications beyond our showed now on syndrome so the sooner you see a lot of already planned strong patterns are interested in all glp to program
spk_0: and invented into discussions on lot of potential long on companies of are expressed an interest in and are you really expect to be updating the market on our our congressmen and me with a got to jump he one bet that is a different or peptide but i'm also we we actually scored high on our it fits very well with our platform and we see a lot of opportunity to deliver an oral glp on on that some orally for invitation such as and be city with chronic indications are that defense has huge potential and yeah i think you'll be hearing more more for months on additional programs as and said beyond jumpy to and potentially a job one great thanks guys about entered girl a by surprise allow he adjacent to scissors zur controller imagine hundred and one such that a common snows us soil and self about the regulatory pathway
spk_13: once we have our been mineral density and for safety data from the on ongoing authors to stay in israel we plan to summarize those data and request and end phase two meeting with the food and drug administration
spk_0: given a favorable outcome of the trial that would generally occurred later in two thousand the twenty one that's the point in time where ft a would
spk_16: tell us what they would find acceptable as and then the i'm sorry as a
spk_17: i'm a comparison of the bonus he changes without while he th on and the are approved our products lilies for tail
spk_1: are helpful thank you very much
spk_0: again ladies job that the have a question or communist this time please press the star than the one key or you touched on telephone
spk_1: the next question comes from carbon party with our capital
spk_0: a good morning
spk_17: how many shares a traditional from the a t m
spk_18: so we currently have current fully in a chair camel's back twenty a little less than twenty four million and apps our primary shark out with us and twenty four million and fighting with a chair camp little less than an hour and thirty two million times so i can tell
spk_19: you specifically on terms of and i'll have the number and and top my had amateur of the saw the new team but that's what can you write a rape checkup erased thirteen million so what price was this pope
spk_0: various prices one
spk_2: various crisis so i i am happy to follow up with you i don't have that number of the top my head exactly how many we saw of i can just tell you exactly what we had out right now okay so thirty two million fully deluded that's correct okay
spk_0: right thanks

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only. Earnings Call, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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