Arcturus Therapeutics Holdings Inc. (NASDAQ:ARCT) Q3 2020 Earnings Conference Call November 9, 2020 4:20 PM ET

Company Participants

Neda Safarzadeh – Head of Investor Relations, Public Relations & Marketing

Joseph Payne – President & Chief Executive Officer

Steve Hughes – Chief Development Officer

Andy Sassine – Chief Financial Officer

Conference Call Participants

Seamus Fernandez – Guggenheim

Madhu Kumar – Baird

Yasmeen Rahimi – Piper Sandler

Gena Wang – Barclays

Disclaimer: *NEW* We are providing this transcript version in a raw, machine-assisted format and it is unaudited. Please reference the audio for any questions on the content. A standard transcript will be available later on the site per our normal procedure. Please enjoy this timely version in the interim.

Operator

[00:00:04] Greetings and welcome to the Arcturus Therapeutics third quarter Twenty twenty earnings call at this time, all participants are in. Listen, only about a brief question and answer session will follow the formal presentation. That he wants to require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Netta, so far, so the head of investor relations, public relations and marketing. Thank you. He may be gay.

Neda Safarzadeh

[00:00:40] Thank you, operator, and good afternoon, everyone. We are joined today by Joseph Payne, president and CEO and the CFO, Dr. Pache, before the CFO and CEO, and Dr. Steve Hughes, our chief development officer. Before we begin, I would like to remind everyone that except for statements of historical facts, the statements made by management and any responses to questions on this conference call constitute forward looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements other than statements of historical facts are included in this communication, including those regarding the company’s supply agreements and potential supply agreements, the company’s future manufacturing and other operations, the status and results of clinical development programs, the planned initiation, design or completion of clinical trials. The likelihood of the success of companies coronavirus covid-19 LAX’s a candidate or other candidates, and the company’s current and future cash and financial position. Our forward looking statements, actual results and performance could differ materially from those projected in any forward looking statements as a result of many factors, including without limitation and inability to develop and market product candidates, unexpected clinical results and general market conditions that may prevent such achievements or performance. Such statements are based on management’s current expectations and involve risks and uncertainties, including those discussed under the heading risk factors. And of course, this annual report on form 10K for the fiscal year ended December 31st, 2019, filed with the FEC on March 16, TWENTY TWENTY, and in subsequent filings with our submissions or the FEC, except as otherwise, because by law we disclaim any intention or obligation to update or revise any forward looking statements which should speak only as of the date they were made, but as a result of new information, future events or circumstances or otherwise. Now it is my pleasure to pass the Japan precedent as the joke.

Joseph Payne

[00:03:15] Please go ahead. Hey, thank you, Netta. Good afternoon to all. Thank you for joining our Cursus quarterly call today to begin. And right off the bat, I’d like to congratulate Pfizer and biotech for the significant milestone announced earlier today. Congratulations to them, their scientists and their team for this accomplishment. We believe this is exceptional validation of messenger RNA therapeutics and vaccines. And Arcturus is very fortunate to be part of this messenger RNA therapeutics community, especially since we’re all working together in this global effort to vaccinate and protect each of us from covid-19 thanks to our partners in Israel and Singapore in supporting us.

[00:04:03] Well, Arcturus has made substantial recent pipeline progress highlighted by our two most advanced clinical programs are CTO 21 is our covid-19 self transcribing and replicating RNA or star Amarone, a vaccine candidate, and asked a 10 hour therapeutic candidate for Ötzi deficiency or sniffin transcribe analyst deficiency. We’re very pleased to today to announce encouraging initial clinical results from both of these programs. And we’ve also made strong progress advancing our earlier stage pipelines, including RCF program for cystic fibrosis. I’ll begin with they are KTO 21, which is also known as Lunner Dash covid-19 or covid-19 to remind you asked 21 is being developed in collaboration with the Duke and UC Medical School and development activities are being performed in Singapore. Today, we’re excited to report for the first time preliminary clinical results from our ongoing Phase one two clinical study. The objectives of the study are to evaluate safety and tolerability and the humoral and cellular immune response and to determine the dose and administration regimens to be evaluated in further clinical development. Our encouraging Phase one two results to which Steve will detail in a few minutes our chief development officer, they provide further support to suggest that are self replicating Hamani based investigational vaccine that this approach, using our proprietary CRM RNA technology, may produce protective immunity at low marnay doses and potentially with only a single administration now based on our interim clinical data. We plan to advance a low single dose of seven point five micrograms, along with prime boost regimens.

[00:06:08] We saw 100 percent seroconversion of Eigg binding antibodies in the younger adults. One out of five older adult participants has not yet converted. The observed geometric mean titers and all of these cohorts exceeded 2500. So the seven point five microgram dose level that’s been selected, focusing in on that specific dose are GMT or geometric mean tighter for this group or the GMT was exceeded 15000 for younger adults and exceeded 2000 and older adults at this dose. The IG binding antibodies continue to increase over time in humans. This is similar in a similar manner to what we observed in preclinical animal models, and we consider that encouraging. The data is still evolving. We remind all that the time course for star Amani technology is extended and different from conventional messenger RNA, which is one of the reasons why we’re seeing activity at such low dose levels. The data that we’ve collected will be published at the time of study completion. We believe that our 021 could be an important addition in the global fight against covid-19. We look forward to advancing our CTO 21 into later stage clinical studies as quickly as possible. In parallel with our clinical development activities, we’ve also made progress with our manufacturing activities of our vaccine, with the support of cattle and rest of farm and other manufacturing partners, Arcturus remains on track to manufacture substantial numbers of doses. Actress announced earlier today on an agreement with the Singapore Economic Development Board.

[00:08:13] To support our manufacturing efforts and Andy is going to be providing more details on that in a few minutes. In August, we signed a binding term sheet with the Israeli Ministry of Health to supply archtop 21. We consider this a core, an important part of the country’s vaccination strategy. Israel is the second country, in addition to Singapore, to preserve supply of Arcturus covid-19 vaccine. And we also continue to have constructive discussions with additional countries pertaining to stockpiling and supply agreements. Now shifting focus to attend for Ötzi deficiency, we continue to make great progress with our lunar OTC program. We’ve completed dose escalation of all cohorts, point one, point two, point three, and now including the top dose of point, four milligrams per kilogram in our phase one study. We’re pleased to report that steroid pretreatment was not necessary even for the top dose cohort. And we’ve commenced enrollment of a Phase one study here in the United States in Otik Division patients, and her first subject is initiated screening. So there’s a lot there to report in one quarter for. Our tourists, I now pass the call to Steve to review and provide more detail pertaining to the FARC 21 Phase one two study results, as well as new phase one data from our FARC 10 or 15 Transport Families Deficiency Program. Steve, thanks to.

Steve Hughes

[00:09:55] I’m pleased to report that the 021 Phase one two study is now fully enrolled with 106 adult subjects, including cohorts of older participants, before discussing the data. I’d like to go over the studies on in some detail. The study is evaluating both a single injection of 021 and fine boost measurements the subjects received in the placebo or 021 in a double blind randomized fashion. In this study, we have single dose cohorts at one five seven point five and 10 micrograms in younger adults and a seven point five point single dose cohort in older adults. We are also testing to dose priming measurements of three micrograms and five micrograms in both younger and older adults. Younger adults are in the range of 21 to 55 years and older adults are greater than 55 years of age.

[00:10:55] To date, 78 subjects have received at least one injection of 021. 36 subjects have received two injections and 28 subjects have received placebo. Our interim analysis includes preliminary results from all single dose cohorts, including the older adult cohort for the two dose cohorts. Although all subjects have now received at least one dose of vaccine data are currently only available for the younger adult cohort at the five microgram dose. These results include safety up to at least 28 days after vaccination and immunogenicity up to the day 43 time point. Although not all subjects have immunogenicity data at a later time points. And for the single dose cohorts, the neutralizing antibody data only goes out today 29 at this point in time, and further data is anticipated. Based on the study, results are robust and despite protein, EGI immune response was observed with 100 percent seroconversion, all doses evaluated in the younger adult cohorts, and only one subject that has not yet converted in the old adult cohort, JMT titers for the ECG antibodies were greater than 2300 in all cohorts. We have selected the seven point five micrograms single dose and five microgram two dose measurements to take forward into further studies. At the seven point five micrograms single dose, the GM geometric mean Midnighter was greater than 15000 in younger adults and greater than 2300 in older adults.

[00:12:34] In the five microgram two dose cohort, the GMT was greater than 16500. The GMT for neutralizing antibodies in the parent 50 assay was within the range of titers observed in the covid-19 patient convalescent plasma tested in the same laboratory. However, as this is an ongoing study, the data are still evolving and not all subjects in the cohort evaluated have complete results for this assay at a later time points as it has to be performed in a BSL three lab and therefore takes a few weeks to get the samples processed. For example, the single dose cohorts only have neutralizing antibody data up to the day. Twenty nine, up to date 29. And the ECG results indicate that titers continue to rise through day 43. So these later time points are important. Additionally, we do not yet have the neutralizing antibody results from the much micro neutralization test that we will that we will be using for our Phase three study, this will be performed over the next few weeks. We will therefore share more data on the neutralizing antibody titers in the coming weeks as these data mature. Turning now to t cell responses, cytokine staining and spot tests showed that T cell responses existed to multiple peptide pools spanning the full length of the sars-cov-2 spike protein.

READ ALSO  "Stand Down Officers!": Angry Crowd Heckles Cops After Toronto BBQ-Owner Arrested For Ignoring Lockdown

[00:13:56] The CD4 response was one dominant and the create responses per cent to peptide that include those from the receptor binding domain of zero to one was generally well tolerated and had a favorable local and systemic adverse event profile. The majority of adverse events have been mild and there have been no severe injection site reactions or fever at the doses that we plan to take forward to later stage clinical trials. No subjects have withdrawn from the study and there have been no serious adverse events deemed to be treatment related. There has been one serious adverse event observed. This was an event of cellulitis from an insect bite and was judged by the investigator to be unrelated to study drug. We continue to collect and analyze data from this study, and we intend to discuss the data with regulatory authorities in the coming weeks as we move towards pivotal trials. Moving now to our top 10 program, part of a plan is being developed for all of the transplant families deficiency, a serious disease, but limited treatment options are a 10 utilizers Altura cislunar lipid mediated delivery platform to deliver Otik messenger RNA to the liver expression of all of the transplant families. Enzyme in the liver of patients with Alutiiq deficiency is expected to restore normal unicycle cycle activity and potentially prevent neurological damage and the need for liver transplantation in these patients.

[00:15:23] We have recently completed a 10 Phase one study, a double blind placebo controlled dose escalation trial in healthy volunteers. The study included four cohorts in total, with Dosti tested between naught point one milligram per kilogram and naught point four milligrams per kilogram. Subjects were randomized two to one active to placebo, and all doses were within the anticipated therapeutic range. All subjects have completed all dosing and all study visits. The study is designed to evaluate safety and tolerability, as well as barbacoa pharmacokinetics as primary and secondary endpoints, respectively. In the study of a 10 was generally safe and well tolerated, most adverse events were mild and severity, and there were no severe adverse events, no subjects only from the study and there were no essays of a 10 has also demonstrated a favorable pharmacokinetic profile. And our preliminary data has shown that no updated lipid was detectable in the plasma beyond 48 hours following Drug Administration. Finally, to phase one two study about a in ITC deficient patients, which is being conducted in the United States on dying day, has commenced enrollment and the first patient has kind of been screening. I passed the call on to Andy.

Andy Sassine

[00:16:44] Thank you, Steve. And good afternoon, everyone. The press release issued earlier today includes financial statements for the third quarter of fiscal year. Twenty twenty, which I will briefly summarize our as primary source of revenue, is currently from licencees and collaborative, received from research and development arrangements with our pharmaceutical and biotech partners. The third quarter, the company reported revenues of two point three million, compared with three point three million in the third quarter in 2019. The decline in collaboration revenues primarily relates to a decrease in reimbursement from carryback associated with the Ötzi collaboration that ended in the third quarter of 2019. Total operating expenses in Q3 were twenty three point three million, compared with ten point nine million for the same period of 2019, the current quarter operating expenses were partially offset, with three point seven million of funds earned under the Singapore vaccine grant and zero point seven million in funds awarded by the Cystic Fibrosis Foundation. Research and development expenses increased approximately 10 million dollars sequentially from the June 30th, 2020 quarter, driven primarily by an approximate increase of four million dollars in each of our lunar Ötzi. They are 810 and Lunar Code 19. They are KTO 21 program, mostly due to clinical and manufacturing expenses. The remaining two million was driven by increased personnel expenses and costs of our two new pipeline programs lunar flu and lunar cardiovascular. Earlier today, actress announced an important manufacturing and vaccine supply agreement with the Singapore Economic Development Board for up to 220 million in additional financial commitment. The ECB will provide a limited recourse loan of 45 million dollars within 60 days, contingent on the delivery of certain documentation.

[00:18:59] The proceeds will be used for the purchase of equipment, materials and services related to the manufacture of our vaccine. Under the terms of the agreement, the loan will be repaid through royalties on future asked 21 commercial sale. If they are 21, development does not succeed or obtain regulatory approval, the loan will be forgiven. Additionally, ARCC, DOWN-TO-EARTH and EDB have entered into a supply agreement for the right to purchase up to 100 and 75 million dollars of ARCC 21 vaccine at prenegotiated prices, which shipment expected in the first quarter of 2021. These funds provide the company with additional resources to support our effort to continue to rapidly scale up our CTO 21 manufacturing to support our existing Israeli and Singapore agreement, as well as other potential supply deals in 2021. Along with our global manufacturing partners, we have laid the foundation to produce hundreds of millions of doses of electricity, 21 over the next 18 months, and we believe the company has an opportunity to positively impact the global covid-19 pandemic. Our cash balance totaled 307 point one million as of the end of Q3 compared to cash and cash equivalents of seventy one point five million at December 31st, 2019. The increase in cash and cash equivalents and investments is primarily due to successfully raising approximately 262 million dollars in net proceeds through two public equity offering in Twenty twenty. Based on our current pipeline, the company’s cash position is expected to be sufficient to support operations for more than two years. I’m now past the call back to Joe.

Joseph Payne

[00:21:01] Thanks, Andy. It’s certainly been a period of strong clinical development progress for our tourists. Looking ahead, we anticipate an eventful period of further clinical progress updates. We’re highly encouraged with the October 21 data that we’ve obtained. We believe the program has enormous potential to play an important role in the global covid-19 vaccine response. In the coming weeks, we anticipate to obtain additional archtop 21 Phase one two study data. And together with the regulatory authorities, we will finalize our plans for further clinical development, advancing this program forward as quickly as possible as our top corporate priority. With respect to the AACTA 10 program, we also anticipate obtaining initial clinical results and Otik patients. In addition to our clinical development stage programs, we’re making steady progress, applying our our powerful image in a platform to develop medicines in a number of promising earlier stage programs. And we look forward to providing you with updates on those in the next year. At this point, we can go ahead and open the line for questions. Operator, please proceed.

Question-and-Answer Session

Operator

[00:22:25] Thank you. We will now be conducting a question and answer session. We would like to ask a question, please. Press star one on your telephone keypad. A confirmation tone will indicate your line is in. The question to you may press star to if you would like to remove your question from the queue for participants using speaker equipment, it may be necessary to pick up your handset before pressing the starches. We ask that you please limit yourself to one question and one follow up question. One moment, please, while we poll for your question. Our first question comes from the line of Seamus Fernandez with Guggenheim. Please proceed with your question.

Seamus Fernandez

[00:23:08] Great, thanks for the question. So few here just trying to get a little bit more specifics and thanks for the additional specifics that you guys provided on the call. Just in terms of the convalescent plasma levels, can you just give us a sense of the the titers that that you saw with the convalescent plasma or, you know, neutralizing antibodies and IGG and also, you know, the types of patients that made up the convalescent plasma, you know, were these, you know, predominantly hospitalized patients just trying to get a better sense of how these how the convalescent plasma comparison metrics up against the the different data that you’ve provided. The second question is on just the young adult patient population, again, relative to the convalescent serum, can you give us a sense of the percentage of the young adult population that, you know, exceeded the neutralizing antibody titers for convalescent serum as well as the egg titers? And then finally, just in terms of the older adults, if you could provide us that same information that we say thank you.

Steve Hughes

[00:24:29] I can address some parts of the question, but not all of the parts at this point in time. So for the convalescent plasma that we got, it had a geometric mean titer for neutralizing antibodies of 147. Those ranged from around 10 to 20, up into several hundreds from the Gulf that we have. We don’t have at this point the ECG finding antibodies for those convalescent plasma, which we need to process those. It was the neutralizing antibodies that we felt were most important for that comparison within the convalescent plasma. It includes both younger and older subjects. So subjects range in age from 24 to 83, 83 years of age. And there’s a range of collection time from from a couple of weeks to several weeks after onset of the illness. We have the convalescent plasma includes subjects that have both mild, moderate and severe disease with the majority of subjects actually in the mild to moderate category as characterization. Would you mind just repeating the last part of the question that you had?

Seamus Fernandez

[00:26:01] Yeah, if it’s possible to share the percentage of young adults and older adults that exceeded the or at least met or exceeded the convalescents levels, I think in your press release this morning, there was some commentary in that regard, but it wasn’t it wasn’t specific.

Joseph Payne

[00:26:20] So at this point, the that the data that we have is still maturing. So this is an interim analysis of an ongoing study, the and it’s primarily to inform our regulatory submissions. So our purpose for doing this data is so that we can advance very rapidly from this study to the next study. Not all subjects have completed the later analysis time points for for the for the neutralizing antibody assay just because it takes some time to actually get those tests processed. You know, we’re we’re in a queue with other with other people, and it has to be performed in a BSL three lab. So it’s actually taking the sample to get the test process takes several weeks. So for that reason, we don’t have full data yet on the neutralizing antibody titers. And the other thing to consider is that for our technology, the later time points are actually quite important because what we see is an antibody titers to continuing to rise over over time. So we’re not really in a position to provide further color on the neutralizing antibody titers at this point. We should be sharing that information over the coming weeks.

Seamus Fernandez

[00:27:31] If I can ask a separate question, obviously the size of biotech data came in, delivered certainly an impressive result, I think you guys know what their data looks like. You know what the threshold, you know, might likely be to sort of predict the, you know, a single dose type efficacy. I was just hoping you might give us a general sense of what you think is achievable in that context with a single dose vaccination, in part because, you know, I think there is a little bit of concern from investors that the single dose vaccination, if it doesn’t have exactly the same threshold of data, you know what what the what the what the bar is going to be from the agency. So does the Pfizer biotech data. Should it shift the bar upward from the 50 to 60 percent threshold to 70 to 80 percent? What’s your confidence that that you could meet if that were a moving bar, that you could meet that with with a single dose vaccination? And, you know, when will we see the data to support that?

READ ALSO  Belgians Told Police Will Knock On Doors At Christmas To Enforce COVID Rules

Joseph Payne

[00:28:48] For one comment, and if the team wants to add, feel free to do so, I think to rephrase your question is what’s the likelihood of a regulatory agency allowing us to proceed in advance this therapeutic given the data that we’ve collected so far? And I think that that’s reasonably high and I think that’s fair to say there. And so we’re going to continue to be able to evaluate this technology and mature it. And and I think that will be the metric that I would like to refer to. And I think the likelihood of us succeeding in advancing this is as high to very high.

Steve Hughes

[00:29:29] Yeah, I just like to also add that at this point in time, there isn’t a lot of protection that actually established. It’s important to consider that subjects with mild disease that have recovered universally for the most part have considerably lower antibody titers than subjects with severe disease. But we’re not seeing subjects with mild disease falling over, with covid reinfection over and over again. There’s only been a handful of cases of Cocodrie infection around the world. So I think what is clear is that sky high levels of neutralizing antibody titers aren’t required for protection. The other important point to bear in mind is t cells. And nobody knows whether for this disease itself is more important than antibody titers, than as a color of protection of disease. And so I think it’s premature to speculate what’s the most important characteristic to see in terms of protection from the vaccine. The experts that we’ve talked to are very confident moving forward that our data looks exciting and looks promising as a single dose. And we’re going to be in conversations with regulatory authorities this week to discuss our data in more detail and about moving forwards with with with a single dose regimen into the next stages of clinical development. So we remain very confident and very excited about our program and confident that we’ll be advancing single doses further in clinical development.

Seamus Fernandez

[00:31:01] Ok, great, I’ll jump back in the queue. Thank you that.

Operator

[00:31:07] Thank you. Our next question comes from the line of Madu Kumar of Bear. Please proceed with your questions.

Madhu Kumar

[00:31:14] Hey, everyone, thanks for taking our questions, so our first one kind of relates to our 21 as well. So is there additional data that the Singapore Economic Development Board had related to our 21 states went to trial that influenced their decision to stay out of the arrangement you guys announced today? Or is the data you put out both this morning and this afternoon kind of the basis for their decision making?

Steve Hughes

[00:31:38] Yeah, well, I think the short answer is yes, the Singapore Duke and USC Medical School is very well aware of our data. They’re running the study and and managing and overseeing many of the development activities. And and that’s where a lot of the positive energy that we get in, the feedback we get as this continues to develop. But to what extent that information is shared outside of Duke and USC? I can’t comment on that.

Madhu Kumar

[00:32:08] Ok, and also, as you’re aware, there was a news article that came out overnight suggesting the Phase three trial trial could start as early as by year end. Does that seem like a consistent with your perspective on things or how are you doing with the timing or pivotal studies for our 21?

Joseph Payne

[00:32:25] So we’re in discussions at the moment with the Singapore regulators and we’ve had a discussion already with with with the FDA as part of a PINDI package, both of those discussions have included the overall design for a Phase three program. We’re continuing our discussions with the regulators, will be having a conversation with Singapore regulator this week and very shortly will also be re engaging with FDA to discuss our Phase three program. So until we’ve actually concluded those discussions, I don’t think we can really make any further comment on on what comes next or the timing.

Madhu Kumar

[00:33:06] And one last one on eight 10 in OPEC deficiency, given the you’ve been able to dose Ascoli with no no kind of obvious safety concerns, is there a reason to not want to look to those hired as the piqué you’ve seen so far, the exposure you’ve seen so far feel like you kind of hit the sweet spot in terms of how much OPEC you can get in there? Or do you think that there’s potential to expand further, given the kind of relatively mild conditions you seem to have seen so far?

Steve Hughes

[00:33:35] So that the study that that has completed is a healthy volunteer study, so we’ve really dosed as high and healthy volunteers as we think that we need to go. We also had the patient study ongoing and we can dose higher in the patients and we will be using the the data from the Healthy Volunteers study to enable subsequent multiple dose studies as well, where we can evaluate these things in more detail. So the short answer is really, we didn’t feel that we needed those higher than healthy volunteers. It’s better to now advance the program as quickly as we can in patients to include more doses and higher doses.

Joseph Payne

[00:34:14] And just to just to help convert the units for people on the call, you know, point for MiGs per kilogram is tens of thousands of micrograms of dosing. This is a, you know, a substantial amount of messenger RNA that we’ve administered systemically or through intravenous application of Marnay.

Madhu Kumar

[00:34:35] The one thing based on what Steve just said, is there reason to think you would need to go to higher doses in locations relative to healthy volunteers? Is there any kind of mechanistic rationale why you would need to dose higher?

Joseph Payne

[00:34:49] No, not not at all. So based upon our animal data, we’ve seen great efficacy in the and the animals, that dose is greater than point one mg per kilogram. So higher doses in in the in healthy volunteers are well within the therapeutic range. And we’ve looked at multiple different biomarker endpoints and also looked at mortality in the animal models. And we see doses of one point one mg per kilogram or greater in the animals efficacy. So we’re very confident that the dose range that we’ve tested already in healthy volunteers is well into the therapeutic range that we’ll need to testing in patients.

Madhu Kumar

[00:35:30] Thank you so much, everyone.

Operator

[00:35:36] Our next question comes from the line of Yasmeen Rahimi of Piper Sandler. Please proceed with your question.

Yasmeen Rahimi

[00:35:43] Team, congrats on the progress that you’re making, a number of questions, all of them are quick clarification question. So the first one or the percentage of zero conversion did you just put out in your four o’clock press release refers to a single or is this a combination of signal and boost? And then I have a number of other little questions.

Steve Hughes

[00:36:10] So FIFA, they the seroconversion data that we just released that we just discussed relates to all those and all cohorts. So for the binding antibody sites and for the binding antibody charges, we have pretty much full data. And what we see is 100 percent seroconversion in the two dose cohorts with which was in younger adults. And we also say 100 percent seroconversion in all of the all of the younger adult single dose cohorts in the older adult single single dose cohort. We’ve seen seroconversion all except the one subject. But for the older adult cohorts, we don’t yet have the later time points. And we know that as time goes on, we see more and more seroconversion. So we’re confident that the seroconversion will continue to increase in older adult cohort.

Yasmeen Rahimi

[00:37:07] Thank you, Steve. And then a second question is, thank you for giving us the GM case also in the 4:00 press release. And thank you for pointing out that it’s over 15000 for the younger adults and twenty three hundred for the older. Can you give us another time point for that single seven point five microgram dose growth so that our investors just felt comfortable that we’re continuing to see an increased response over time?

Joseph Payne

[00:37:36] Can I rephrase the question for Steve? Are you asking that if the the IG antibody GMT, if those increased going from day 29 to day 43, for example, I can only refer to the to what we’ve already mentioned. I can refer to the script to Steve CLECs, maybe his thoughts as well. But, you know, we’re very comfortable in saying that the the that just reviewing my my script that that the IG binding antibodies continue to increase over time in humans in a similar manner to what we observed in preclinical animal models. And to refresh your memory, where we were with animal models of this particular data continue to increase to approximately 50. Now, we did not take a day, 50 time point in humans, but we we’ve mentioned day 43. So that’s why we use approximate and it’s still continuing on. But yes, we can assure people that with respect to IG binding antibodies, that they continue to increase in humans over time. And we don’t have the data on point yet. And we had alcohol. And for some of these cohorts, as Steve mentioned, we don’t have the complete data package. So this data continues to evolve.

Yasmeen Rahimi

[00:38:57] Thank you. Well, I guess I was just thinking of you have something a day 15 or earlier and you could share that, that we could actually compare it to the time point that you just referenced.

Joseph Payne

[00:39:06] So that was that was the thought process. So I define the geometric mean tighter for the older adults was I was about 20 to 25 percent of the geometric mean tighter of what we saw at day 29. Yeah, and they ate it was about one third of what it was at day 15. So from day to day 15, it increased about threefold from day 15. Today 30, today 29. So today 36. It increased in the range of of of two to threefold. Yeah. So it is continuing to rise.

Yasmeen Rahimi

[00:39:48] Thank you. And then one last question, you know that as you pointed out, 36 of the patients received two doses. So can you maybe comment on moving forward? You know, sort of which what percentage of the population may require a booster shot in two doses to the extent you can comment on based on the data that you’ve seen so far. And then thank you again for taking my questions.

READ ALSO  Divine and damned - The blessed and cursed life of Diego Maradona | The Americas

Joseph Payne

[00:40:16] Right. So so you’re you know what what populations respond to the single administration versus the administration? You know, some people have speculated that the elderly population will be, you know, have weakened immune responses. So that may end up being the case with our tourists. But we don’t have that data yet. Steve?

Steve Hughes

[00:40:40] I think so. Based upon the single cell data, we’ve seen very robust bonding antibody data across all of the cohorts. The older adult cohorts, like with all of the other vaccines, have a slightly lower geometric mean tighter than the younger adult cohorts. But even for the older adult cohorts, we’ve seen that the geometric mean title is over 2300. So they’re robust finding antibody titers that we’re seeing across all age groups and all cohorts for the neutralizing antibody titers. We don’t have a lot of time point yet. And so that data is still evolving and we’ll be able to provide more color as time goes on. But the data that we do have show that mentalities are within the range of what we see for subjects that have had covid-19 under way in the convalescent phase. And if we’re not, if there is a subpopulation that doesn’t respond as well as others are we utilize a non-viable delivery technology that is multi possible so that that’s one of the features of this product.

Yasmeen Rahimi

[00:41:45] And thank you to you for taking my question. And thank you for the answer.

Operator

[00:41:53] Thanks, yes. Thank you. Our next question has come from the IG on the charm of it, of Citigroup. Please proceed with your questions.

Unidentified Analyst

[00:42:00] Yes, hi, thanks for taking the questions. I’m just another one on the single dose versus the prime boost, you’ve talked about both. Could you just give us a little bit more understanding as to how are you going to take you’re going to take both of those forward? Are you going to make a decision to only take one forward? Could you just provide a little bit more context as far as as far as whether whether you’re going to commercialize both a single dose and the prime boost or make a decision to only go forward with one of them?

Steve Hughes

[00:42:34] So at this point in time, this is again, at this point in time where we’re advancing both single dose and time boost regimens forward into the next stage of clinical development, where we’ll evaluate further in several hundred subjects and then we’ll rapidly advance one of those regimens into late stage strains of enter into a registration study. So in a registration study, we’ll just take one forward. We still have confidence in the single dose regimen, which is why we are advancing that for the next stage of development. But we’re also testing two doses in that next study. And then we’ll very rapidly move to phase three with with just a single measurement. And at this point, it’s we can’t say that it will definitely be a single dose regimen, although we’re confident that the single dose has adequate immunogenicity to be protected in humans.

Unidentified Analyst

[00:43:26] Ok, thanks. And do you plan on publishing the results of this study in the near future?

Steve Hughes

[00:43:33] He has also indicated a little while ago we’re planning to publish the results of the study when the study is complete, which the study should study will complete in the first quarter of next year, and then we will publish or summarize the results and publish them thereafter. The issue that we had at the moment is that, you know, this is an ongoing study. So the data is evolving. So trying to publish their data based upon data that, you know, could shift is that it is a little premature.

Unidentified Analyst

[00:44:00] Oh, thank you.

Operator

[00:44:06] Thank you. Our next question comes from the line of doing away with Berkeley, please proceed with your question.

Gena Wang

[00:44:12] Into taking my questions. I have a few and I just wanted to confirm, you mentioned that GMG have a 147 for convalescents. You just want to confirm those are the print systems and the one hundred forty seven is a new medium.

Joseph Payne

[00:44:30] But the it is different 50 and the 147 is a geometric mean, which is what is usually used for pocket is done, as I say.

Gena Wang

[00:44:38] Ok, perfect. So then what is the upper end of those 54 convalescents there?

Joseph Payne

[00:44:49] So the the upper end that goes all the way that up the upper end is for subjects that have severe disease and that I don’t have the numbers right in front of me, but it’s several hundred at least.

Gena Wang

[00:45:03] Ok, so when you come in, you know, the 50 GAAP within range of spiders in the convalescents jelly, are you referring to the top of them overlapping with the top end of the convalescence from those who are single dose and two doses over?

Joseph Payne

[00:45:24] Now we’re referring to the range.

Gena Wang

[00:45:28] Ok, and then any differences between single dose seven point five, Michael Brown versus the produced by Michael Goodwin in terms of a principly.

Joseph Payne

[00:45:39] It’s not possible for us to make that determination at the moment just because we we don’t have the full data set from the single doses. As I mentioned, we don’t have a lifetime points. And for of vaccine technology, the antigen levels continue to increase over time. So we see increasing levels of increasing titers over time. So it’s going to be a few weeks yet before we’re able to make the comparison between the single dose and the two dose regimens for for for any of the doses. However, we do see very robust antibody titers in the five micrograms single dose cohort, as we do in the five microgram, two dose cohorts.

Gena Wang

[00:46:20] Ok, so, I mean, just a comment, the others. You know, they are principessa all mutualizing antibody, actually a 14 days off at least. So just wondering, based on the day 29 of what data could be look like compared to, you know, any differences to be, you know, do you see between single dose versus booze? And then a related question is certainly forward. Next step, seven point five microgram, both single dose and the two doses just want to combine those two doses is seven point five micrograms per ton boost. And they want me decided to choose seven point five microgram, over five micrograms did so far.

Joseph Payne

[00:47:03] So, yes, well, we’ll be taking actually in the in the next study will be taking seven point five single dose, five microgram, two doses, seven point five to dose regimens forward. So we’re evaluating three different dose regimens and both younger and and older adult cohorts. The reason for selecting seven point five to move forward is that the seven point five microgram dose was as equally well tolerated to the five microgram dose. And so it made sense to move forward with with the higher dose, then a lower dose, given that at this point we’re not able to make a determination as to whether a single dose or two doses both effective, but we don’t we don’t have the later time points for the single doses. But in order to advance the program quickly, we mean we need to make decisions with incomplete information. So we’re taking seven point five forward. That was very well tolerated. It was as well tolerated, if not better tolerated than the five microgram dose. And and we’re also taking five and seven point four five forward as as a test regimen of expensive.

Operator

[00:48:15] Thank you. Our next question comes from the line of Steve Steve with Raymond James. Please proceed with your question.

Unidentified Analyst

[00:48:22] Exactly, and thanks for taking the question. I guess I’m just confused to this conversation. Did you end up actually dosing people with 10 micrograms? And if you did, what went into the decision ultimately to advance seven point five in both a single and double dose regimens?

Steve Hughes

[00:48:41] So we did go, say, 10 micrograms without a single single dose cohort at 10 micrograms at the 10 microgram dose, we saw some grade three tolerability events. And and so we we chose to move forward with the seven point five dose as opposed to 10 micrograms because seven point five was extremely well tolerated with zero grade three events. And we don’t believe that we’re going to see any trade offs based upon the immunogenicity results that we’re seeing by going with a slightly lower dose.

[00:49:15] Does it make sense? Could you maybe just elaborate with those things like fever, chills, muscle aches, muscle pain that have been seen with other covid vaccines or those?

Joseph Payne

[00:49:24] So we haven’t seen any fevers that are great today. In fact, all any fever. We haven’t seen any any fevers that are more than mild and at any dose levels in the study. I can’t honestly remember the top of my head what what the grade three events were in in the study. So I can’t really comment specifically. They just were great to tolerability events that were, you know, within the vaccine grading scale for those events.

Unidentified Analyst

[00:49:58] Ok, fair enough, and then maybe on manufacturing, last question, what scale on a dose basis and maybe this is an unfair question. It could be too early, but I know others, particularly with MRSA vaccines, throughout some estimates pretty early. So what scale do you think you can manufacture the vaccine? And let’s just say 20, 21.

Joseph Payne

[00:50:20] All in 2021, I think Andy mentioned some, you know, provided some guidance there that we have the foundation to do, you know, very large manufacturing campaigns. But, you know, we’re in the scale right now that’s sufficient to supply for Israel and Singapore. And we have a process that’s scalable for both the process to make the messenger RNA construct and to formulate it and to fill finish in my office. Is it so and we have the partners that help us with this capacity, like we mentioned, Catledge and Rest Farm So and others that are helping us here. So we’re our our manufacturing horizon is very promising. Our technology is is validated and tech transferred and we’re in good shape there. And do you have an extra comment?

Steve Hughes

[00:51:09] Yeah, just just one other comment. You know, as Andy mentioned, know, we did receive an additional 45 million dollars for procurement of raw materials for our manufacturing effort. So what would that additional fund you know, we were getting ready to get a lot of the key raw materials up to a kilogram scale and get that order so that we can be when they were in manufacturing for next year.

Unidentified Analyst

[00:51:35] No, thank you.

Neda Safarzadeh

[00:51:39] That is all the time we have for questions today. I would like to turn the clock back over to president and CEO Joe for any closing comments.

Joseph Payne

[00:51:48] Hey, thanks, everyone, for listening. It looks at this point we’re going to close the call, but feel free to reach out. As always, if you have any follow up questions, we will be as efficient as we can in our responses. Bye for now.

Neda Safarzadeh

[00:52:02] Thank you. This does conclude tonight’s call. You may disconnect your lines at this time.

Operator

[00:52:07] Thank you for your participation and have a great day.



Via SeekingAlpha.com