Q4 2021 Athersys Inc Earnings Call
Good evening. Thank you for attending today's average just year end 2021 results Conference call. My name is Selena and I will be your moderator all lines will be muted during the presentation portion of the call with an opportunity for questions and answers at the end if you like to ask.
Your question. Please press star one on your telephone keypad I would now like to pass the conference over to our host Karen How did you with <unk>. Please go ahead.
Thank you Elena and good afternoon, everyone I'm, Karen Kennedy director of corporate Communications and Investor Relations for Adler said.
Thank you for joining today's call. If you do not have a copy of the press release issued at the close of market. It is available on the <unk> website <unk> Dot com.
I'm pleased to introduce Dan <unk>, who started as our Chief Executive Officer on February 14th.
I'm also here with BJ Lehmann, our president and Chief operating Officer, and Ivor Macleod, our Chief Financial Officer.
A webcast of the audio will be available three hours after the call's conclusion on.
Our website under the events section.
The access information for the replay is also in today's press release.
Any remarks that we may make about future expectations plans and prospects.
Institute forward looking statements for purposes of the Safe Harbor provision under the private Securities Litigation Reform Act of 1995.
Actual results may differ materially from those indicated by the forward looking statements as a result of various important factors, including those discussed in our forms 10-Q, 10-K and other public SEC filings.
We anticipate that subsequent events and developments may cause our outlook to change while we may elect to update these forward looking statements at some point in the future, we specifically disclaim any obligation to do so.
For the benefit of those who may be listening to the replay.
This call withheld and retail reported on March 15th of 2022.
Since then we may have made announcements related to the topics discussed. So please reference our most recent press releases and SEC filings.
With pleasure I would like to introduce you all to the new CEO of addresses Dan Commander I'll turn it over to you now Dan.
Thanks, Karen.
Excited to be leading asset at.
Such a pivotal time as I believe we have the potential to be a global leader in cell therapy and regenerative medicine.
Effectively treat various diseases with significant unmet medical need.
I am also well aware of the challenges the company has faced over the years and I'm prepared and eager to meet those challenges head on while capitalizing on the opportunities ahead.
Please allow me a minute to share some of the highlights of my background before joining after assist on February 14th 2022.
I've come to address this after more than 25 years in the pharmaceutical and biotech industry with experience of having delivered numerous successful therapies to market.
Privilege that brings with it all satisfaction of both helping patients and creating shareholder value.
I enjoy building effective teams growing businesses and launching innovative products, especially in disease areas that are difficult to treat or have few or no approved therapeutic options.
Most recently I was executive Vice President and a member of the Executive Committee of Horizon Therapeutics, where I was part of an executive team that transformed our small specialty pharmaceutical company with a $2 billion market cap in 2015.
So our global Biotechnology leader with 11 in market products, and our market cap approaching $23 billion.
During my six and a half year tenure, we develop exceptional commercial capabilities that enabled us to build a diverse and highly profitable portfolio.
Rare disease products and to grow the business by acquiring undervalued assets and repositioning them in the marketplace.
I'm also proud of the high performing results driven culture that we've created driven by our core values of transparency collaboration and accountability.
My other significant commercial experience was that Astellas pharma, where I spent 11 years, starting with the U S market entry of Yamanouchi Pharma America in 2003.
During my time with Astellas I had a chance to participate in the commercial build out of the company following the merger with Fujisawa and the launch of several innovative products.
Played a leadership role in a number of successful co promotion and licensing deals most notably <unk> for overactive bladder with Glaxosmithkline and extend the for castration resistant prostate cancer with Medivation.
When I left the Astellas in 2014, the company reported more than $3 billion in U S. Net sales and we had built a broad portfolio of specialty products in the areas of urology oncology immunology and hospital care.
Now many people have asked me why it would be leaving my role at horizon, whereas one of the top executives with responsibility for horizon successful and highly profitable inflammation in rare disease businesses and.
And give us the financial rewards that come along with scaling our business to evaluation of $23 billion to join addresses a company with a market capitalization of less than $200 million.
First let me say that I was not looking for a new job nor to leave horizon.
But when the assets. This board reached out to me by research the company and quickly became intrigued.
In particular, I saw a company with deep scientific expertise and stem cell biology, and the passion and commitment demonstrated by the companys employees to bring multistem to market that help patients suffering from serious life threatening diseases, such as stroke acute respiratory distress syndrome and trauma.
These diseases are not only difficult to treat but can be devastating to individuals and families and result in significant health care costs.
And although cell therapy has more recently become a growing area of interest in our industry and this has been studying the effects of multistem and the scientific basis for its mechanism of action for more than 15 years.
While all of this was interesting I would not have taken the job unless I was satisfied with my own due diligence into the company.
So let me share with you some of the due diligence that I completed before I agreed to accept the position as CEO of addresses.
First I met with every member of the board of directors and as pointed questions about the opportunities and challenges facing the company.
Second I met with every member of the senior management team to understand the internal capabilities as well as the companys future needs as it continues to work towards commercialization.
Third I reviewed all preclinical and clinical studies, especially masters one in detail.
Fourth I studied the various research papers about the scientific basis for Multistem mechanism of action and I also spoke with several physicians, who treat stroke and acute respiratory distress syndrome.
And lastly, I spoke with several consultants in the gene and cell therapy space to better understand the manufacturing and regulatory challenges facing this evolving area of the industry.
My due diligence not only confirmed my initial interest, but got me excited about the prospects for <unk> with a new leader in place.
I resigned from horizon and accepted the job at <unk> in full recognition of the challenges the company has faced.
And with the conviction that we have a unique opportunity to become a leader in regenerative medicine treat patients who have been suffering from these very difficult to treat diseases and generate substantial shareholder value.
Since joining the company on February 14th and learning more about Multistem has unique properties.
Meeting the internal team and better understanding the business opportunity my conviction has become even stronger.
Specifically, our branded multi potent adult progenitor cells or a mab C therapy provides us with a highly attractive platform with significant growth potential across different inflammatory diseases, as well as neurological and immune disorders.
From the clinical trials already completed more than 400 patients have received multistem.
Most importantly, the results of all of those trials and analysis have consistently demonstrated safety and a very good tolerability.
And like more conventional drugs and biologics the Multistem product candidate is cleared from the body over time, which we believe may enhance the product safety relative to other types of stem cell therapy.
There have been more than 88 scientific publications on map C, which is a distinctly different cell type from an MSC are mesenchymal stem cell and we hold more than 450 patents related to our technologies, providing us with IP protection in the U S Europe , Japan and other areas.
Over the last year, we have made significant investment in progress and our ability to manufacture and scale model multistem in a predictable and efficient manner, which as many of you know can be a challenge with other stem cell therapies.
In addition, I have been impressed with both the technical and executive teams at the company, which includes several new members who have started over the past year or so with proven experience in process development and manufacturing capabilities that will help further support commercialization plans for both <unk> and our Japanese partner Helio.
Yes.
As the new leader of addresses I know, it's my responsibility to earn the trust of all key constituents employees shareholders and commercial partners.
My style is to be completely transparent and say say it like it is.
When I said expectations, they will be what I believe to be both ambitious and achievable and we will all work as diligently as we can to meet or exceed those expectations.
And with that in mind I'd like to address expectations on the timing to complete masters two enrollment.
Over the last couple of years. This trial has experienced challenges in its clinical site initiations as well as patient screening and enrollment due to the COVID-19, pandemic and supply disruption disruptions among other things.
We've undertaken initiatives intended to accelerate new site openings in the U S and abroad and increased patient enrollment at sites that are currently opening including addressing site operational issues and local product supply constraints.
These actions are intended to enable the company to finish enrollment of the Masters two study by the end of 2022 or as soon as possible thereafter.
Another area I would like to address today is corporate partnering.
I have a lot of experience in building healthy mutually beneficial and successful corporate partnerships.
This is a particularly important element of the strategy for developing biotech company.
It is critical to structure. These partnerships in accordance with the overall corporate strategy aligned interest among the partners and execute on a win win formula for each company.
It is fair to say that as <unk> had a mixed record so far with corporate partnerships and we intend to fix that.
I am pleased to see that following the execution of the cooperation agreement in February 2021, and the comprehensive framework agreement in August of 2021, the relationship between <unk> and Helios has dramatically improved.
In fact, I can report that both companies are working very closely together as true partners in a mutually supportive way on regulatory matters manufacturing and preparations for commercialization in Japan.
Confident that we can build on this progress and continue to deepen our relationship to ensure a mutually beneficial partnership with Helios.
We are approaching several important milestones with our Helios collaboration, including a potential regulatory filing for arts, the UN blinding and release of the treasure trial results for stroke and preparations for a potential commercial launch in Japan.
<unk> will be working closely with <unk> every step of the way to assist and support success on every one of these important initiatives.
And finally I'd like to make some comments on the status of manufacturing.
The first generation cell factory manufacturing process that the company has been using up to this point for our clinical products has experienced various issues and delays over the years.
With improvements to this process and FDA approval of our second generation bioreactor process.
We believe that the company will have sufficient product in inventory to support all ongoing clinical trials by the end of second quarter.
We intend to start building with <unk>, the initial product necessary for a potential commercial launch in Japan and.
And our intention is to transition over to the larger scale bioreactor production process, which can yield substantially greater volumes to support the future potential growth in Japan as well as the requirements for potential launch in the United States Europe , and the rest of the world.
The initial test runs with a large scale bioreactor process had been successful and we will be working to build out this production platform for larger commercial needs based on the timing and results of upcoming clinical and regulatory milestones.
And now I'd like to turn it over to BJ Lehmann, who will provide an update on our active phase III program in stroke as well as our phase two three clinical program in <unk> and our phase II trial in trauma P. J.
Thank you Dan.
And our stroke program. We have ahead of us important milestones demonstrating the therapeutic benefit of Multistem treatment first the upcoming announcement of data from the Japan Treasure study.
Followed ultimately by completion of our larger Masters two study being conducted in the U S Europe and other regions.
In the near term we are looking forward to the results from the treasure study being conducted by our partner <unk> in Japan.
The study is evaluating intravenous multistem treatment of over 200 patients with moderate to severe strokes is well powered to detect efficacy in this population.
The last patient follow up is expected this month, meaning that data cleanup and analysis can be completed over the next several weeks.
As we have communicated previously the treasure and Masters two studies have similar designs, meaning that the treasure study would be a strong indicator of the potential results from the Masters two study.
Based on our prior Masters one results in the study design, we are optimistic about the results and their potential for demonstrating therapeutic impact for stroke patients.
Additionally, the data would enable us to confirm our masters two strategy and design and make any necessary adjustments.
We will continue to work closely with Helios to support the application process in Japan and to further establish manufacturing capacity for initial commercialization.
Naturally Helios is regulatory and commercial progress would benefit us providing confirmation regarding the quality and sufficiency of the application package.
And ultimately certain milestones and royalty payments.
We continue to make progress in enrolling our masters two study in prior periods as Dan mentioned, we've faced challenges to clinical site initiations as well as patient screening enrollment.
Due to the COVID-19, pandemic and supply interruptions among other things.
As COVID-19 case numbers decline in supply has stabilized we have undertaken initiatives intended to accelerate new site openings in the U S and abroad and increased patient enrollment at open sites, including addressing site specific operations and inventory management issues.
These plans are intended to enable us to finish enrollment of the Masters two study by the end of 'twenty, two as Dan mentioned or as soon as possible thereafter. However.
However, timely completion depends on the success of these initiatives the impact of the treasure results on site activity and the possible resurgence of COVID-19.
We would expect for instance that favorable treasure study results would have a positive effect on site initiations and patient accruals as to his success drives further interest in and focus on the study amongst investigators and clinical research groups.
In recent months, we have initiated 10, new sites, including in Australia, Taiwan, and Europe , bringing us to more than 30 sites.
And we've also had our first patient enrollments outside of the United States.
We expect to continue the vigorous initiation of additional sites in the U S and outside.
We believe the contributions of these new sites will be important to efficient enrollment of the masters two study.
On the regulatory front, we have utilized our <unk> designation to have frequent discussions with the FDA about our development plans.
We are pleased to report that we have reached agreement with the U S and European regulators to defer our pediatric development plans for stroke.
This is an important development because it means that we will not have to complete pediatric development prior to applying for market marketing approval, but we can address such development following approval.
Turning to our other programs as we have stated in recent communications, we have amended our <unk> study to include a more general <unk> patient population not just COVID-19 induced ards, which is consistent with our longer term development plan in this area.
Our operations plan for the <unk> study is to work to complete the phase II part of the study by the end of 2022, depending among other things and Covid pandemic incidents and site level activity.
Given changes in standard of care for <unk> patients.
Patients in light of the Covid pandemic we.
We plan to take stock before proceeding with phase III portion of the Mccovey a clinical program.
Importantly, with recent approval from the FDA, we are able to use the bioreactor manufactured product in the study.
This will enable us to generate valuable clinical data with our next generation bioreactor based products and lay the groundwork for subsequent clinical work with our larger scale bioreactor format.
In August 2021, Helios reported top line data from its one bridge study in Japan for pneumonia induced.
Pneumonia induced in Covid induced ards patients.
The data from the one bridge study is consistent with our data from the must Ards study demonstrating favorable trends with respect to impact on pulmonary function. For example in ventilator free days mortality and quality of life.
Even though some recent improvements in <unk> standard of care have been made this remains an area of high unmet clinical need.
Due to the high treatment cost of arts, a successful cell therapy could be expected to generate significant savings for the health care system by reducing the number of days on a ventilator.
In the ICU, and importantly can reduce mortality and improved quality of life for those suffering from the condition.
Following the one bridge topline readout Helios and we have conducted thorough analysis of the data from the must Ards and Woodbridge studies.
The studies have comparable patient populations, receiving the same multistem dose amount shortly following an <unk> diagnosis.
Between the studies, excluding the Covid Arts cohort and the one bridge study <unk>.
60, <unk> subjects were enrolled in the studies 40, receiving multistem treatment and the remaining 20, receiving placebo or standard of care.
On a pool basis strong trends were observed in ventilator free days or BFD survival improve.
Improved quality of life and reduction of key inflammatory biomarkers.
For example, multistem treated subjects had on average five five more ventilator free days in the first 28 days following diagnosis the non treated subjects subjects with a P value of 0.07.
And on a median basis 10, five more ventilator free days during that 28 day period.
Further there was also a strong evidence of favorable impact from treatment on mortality and quality of life metrics.
This combined data gives us further confidence in the potential for multistem treatment to have a substantial positive impact on <unk> patients.
<unk> continues its consultations with the regulatory authorities to prepare for the potential application for manufacturing and marketing approval.
We are working closely with Helios to prepare the regulatory applications for approval and for potential commercialization in Japan, which if successful could allow them in 2023 to achieve marketing approval.
We look forward in late March.
To the pre application consultation announced by Helios.
Yeah.
As we noted in the previous call. We also plan to continue evaluating and exploring opportunities for governmental support programs such as BARDA, where there is a fit with our development strategy.
In trauma, we are conducting a phase II clinical trial evaluating multistem cell therapy for the early treatment of traumatic injuries and the subsequent complications that resolved following severe traumatic injury. This first ever study of a cell therapy for the treatment of a wide range of traumatic injuries is being conducted.
By UT health at the Memorial Hermann, Texas Medical Center in Houston, Texas, one of the busiest level one trauma centers in the United States.
And it's supported by grant funding, including from the Federal government.
As is the case with the Mccovey study with recent approval from the FDA, we are using the bioreactor manufactured products in this trial.
The matrix study builds on therapeutic elements relevant in our other critical care programs such as the modulation of the severe inflammatory response generated by ischemic infectious or traumatic events and the reshaping of the immune system response to improve the recovery path.
We believe the Multistem therapy should have great potential to benefit accident victims battlefield casualties, and others suffering dramatic injury by improving recovery survival and quality of life.
Finally, I would like to provide an update on our collaboration with Helios building on Dan's comments.
In 2021, we amended and improved our collaboration arrangements with Helios to better align and drive optimal investments and efforts in manufacturing regulatory activities.
And ultimately commercialization in Japan.
In general both parties intended to create a framework for strong atheros to support regulatory supply and manufacturing were beneficial.
Mechanisms for Helios to take on greater responsibilities for manufacturing and supply over time.
And opportunities and incentives for full development and commercial success in Japan.
I am pleased to confirm that these changes have led to much improved joint efforts to develop the multistem programs in Japan.
We are working closely with Helios provide support and the regulatory processes to assist Helios and establishing manufacturing capacity for initial commercialization.
And the plan for longer term commercial supply and development of the Japanese market.
We look forward to the upcoming treasure study data into continued progress by Helios and the regulatory applications process.
Which represent important milestones in the development of the Multistem platform.
With that I will now hand, it over to fiber for the financial update Ivor.
Thank you Vijay and good afternoon everybody.
Mcleod Chief financial officer of emphasis I would like to thank all of you for joining today's call.
First I will give an overview of the fourth quarter of 2021, and then follow with the financial results for the full year.
Revenues were 722000 for the three months ended December 31, 2021, compared to $1 3 million for the same period in 2020.
The revenue is related to the ongoing services that we provide to our partners.
Supporting our collaboration in Japan.
Research and development expenses were $18 7 million for the three months ended December 31.
Minor increase of $58000 compared to the expenses for the comparable period in 2020.
General and administrative expenses decreased to $3 4 million for the three months ended December 31 2021 from.
<unk> from $4 $3 million.
In the comparable period in 2020.
The decrease in the fourth quarter of 2021 was due primarily to lower outside services legal and professional service fees of $874000 and lower stock compensation costs of $336000.
Increased personnel costs of 255000.
The net loss for the fourth quarter was $21 7 million in 2021.
<unk> to a net loss of $22 2 million in the fourth quarter of 2020.
I will now turn to the results for the full year.
Our revenues were $5 5 million in 2021 compared to $1 $44 million in 2020.
Primarily related to our ongoing collaboration with Helios.
Collaboration revenues currently fluctuate from period to period based on the delivery of goods and services under our arrangement with Helios.
Research and development expenses was $71 1 million in 2021 compared to $63 million in 2020.
The increase in expenditures is primarily related to an increase in clinical trial and manufacturing process development costs of $5 3 million.
An increase in personnel associated costs of $3 2 million, partially offset by a decrease in other costs of <unk> 4 million.
The increase in these costs overall is primarily related to our progress and large scale <unk> manufacturing expenses.
Expenses related to our ongoing clinical trials.
Our overall R&D expenses will continue to vary over time based on clinical trials underway. The number of manufacturing campaigns, we run and our continued process development activities as well as other initiatives.
General and administrative expenses were $20 1 million in 2021 compared to $59 million in 2020.
$4 2 million variance is primarily related to increased outside services legal and professional services of $1 7 million.
Personnel and associated costs of $2 5 million, which includes stock based compensation of approximately 890000.
In 2021, it's important to point out we experienced significant onetime expenses related to executive severance as well as professional fees associated with the Pos litigation with Helios.
The subsequent consummation of our comprehensive framework agreement.
In aggregate these onetime expenses.
A $5 million in 2021.
Our net loss was $87 million in 2021 compared to a net loss of $78 8 million in 2020.
The $8 $2 million difference reflects the aforementioned variances.
In the 12 months ended December 31, 2021, net cash used in operating activities was $76 million compared.
Compared to $62 million in the 12 months ended December 31 2020.
At December 31, 2021, we had $37 4 million cash cash equivalents compared to 51 5 million at December 31 2020.
Our cash burn in 2021 varied between 17 and $20 million per quarter.
With the burn in the fourth quarter being just over $19 million.
We do feel we have adequate cash to fund our near term priorities through and beyond the publication of Helios is topline stroke data.
While we continue to have access to our equity line with aspire capital.
Positive topline stroke data could provide us with several options for raising further capital.
With that I will turn the meeting back over to Dan for Q&A Dan.
Thank you Oliver wed like to take time now to address questions that were sent in ahead of this call before we open up questions from our analysts.
And we've had several questions surrounding our financial position and the current stock price, so I'm going to ask Ivor to address these items.
Thank you Dan.
I'll first address the questions about our current stock price.
We continue to believe that our stock price is severely undervalued, especially for a biotech company in late stage development on the cusp of what we believe will be a significant data readout from our partner Helios in Japan.
That being said the overall sentiment in the capital markets. This year, particularly in our biotech sector have been extremely poor.
DXP index, which our stock tends to follow is down approximately 28% this year.
DXP index represents the biotech segment of the S&P total market index.
The NASDAQ is off 20% in the S&P 500, approximately 12%.
Macroeconomic factors continue to weigh heavily on overall sentiment.
The fed meeting is occurring today and tomorrow a quarter percent rate increase is almost guaranteed.
But more important is the outlook for the year, particularly on inflation, which they greatly underestimated in December of two 7%.
There is also the geopolitical crisis in Ukraine.
Certainty around not only the outcome.
The permanent in nature of the various economic sanctions imposed against Russia.
And in China, while Covid cases are low by global standards.
Zero tolerance policy is leading to lockdowns and potential further interruptions to the global supply chain.
Against this backdrop, the biotech IPO market is somewhat drydock.
With a low single digit number of Ipos this year compared to 78 in the corresponding period last year.
Following similarly has been in the single digits compared to 175 in the comparable period last year.
Well here the emphasis we continue with managing our priorities, which we mentioned earlier in the call rather than on our stock price. We do expect the near term catalysts, particularly the release of the treasure data stroke from our Japanese partner to provide a boost to our overall valuation.
Regarding our cash situation as I said earlier in the call. We feel we have adequate cash to get us through our near term catalysts, including getting to the other side of the publication of the topline treasure data.
Following what we believe will be positive data, we anticipate multiple opportunities for us to raise additional capital on what would be much better than current terms.
We also continue to have access to our equity purchase agreement with aspire.
While we are hesitant to sell at the current price level, we have lowered the floor price to 50.
Which gives us the flexibility should it be required.
With that I'll give it back over to Dan.
Thank you <unk>.
We have also received several questions relating to our motto via trial for the treatment of <unk>, specifically about our progress on cohort two and how this may affect our plans for cohort three.
So BJ, if you wouldn't mind, providing some more insight for us sure Dan I'm happy to.
As I mentioned, a few minutes ago based on our research and recent clinical data. We are very positive about the potential for multistem therapy to help patients with Rds.
In addition to providing information to confirm the design of our cohort three portion of our study we have planned in cohort two for a bioreactor manufactured product to be used and.
And with the recent FDA approval, we are integrating this product now into this study.
In addition, we will be adding some more clinical sites and we hope as I mentioned before to complete enrollment of this cohort two by the end of the year.
With that data in hand, we would confirm our cohort three designed to ensure that we have the best designed for success before moving forward potentially next year.
Dan Great. Thank you BJ.
Another topic that comes up relates to masters, two and based on the number of sites open and Masters two why do we think will be enrolled by the end of this year and I'm happy to take this one.
As BJ mentioned, we now have over 30 sites open initiating 10 new sites.
In the United States, Europe , and Asia, just over the last several months as COVID-19 hurdles have diminished and we plan to initiate more sites shortly.
Now these sites are all leading stroke centers and are often high profile research institutions with the most advanced technologies stroke care and clinical research capabilities.
Importantly, while we are nearly completed with the clinical supply manufacturing for this trial, which will enable us to be more aggressive in our clinical operations and we've put in place several actions to improve enrollment at open sites.
The next set of questions. We received was around the upcoming treasure data readout.
What are our expectations and what does this mean as it relates to our current Masters two study.
BJ, if you wouldn't mind, taking those questions sure.
Now as I, just discussed a few minutes ago, and we've talked about in the past in particular in our presentation earlier in February .
We remain very confident with respect to the potential for Multistem in ischemic stroke.
Based on our observations from our Masters two trial plus all the research we conducted before that.
Importantly, both the treasure and Masters two studies are similarly, designed based on the results and learnings from the Masters one study and are well powered for success.
We believe that favorable results from treasure will read through to Masters two.
Meaning that we would have high confidence in the success of Masters two.
Dan.
Thanks Vijay.
There is another topic that I like like.
To cover if you don't mind Vijay we received several general questions related to our buyer buyer reactor manufacturing process. So can you provide an update on progress on this front.
Now I'm happy to do that.
First we are saying we continue to make very good progress in developing our bioreactor manufacturing process and capacity.
To serve the commercial markets following potential approvals by us or our partners such as Helios.
As I mentioned earlier and importantly, we have recently received approval to use product manufactured using our bioreactor platform for clinical trials.
Additionally, we are transferring our next generation larger scale bioreactor technology to establish GMP manufacturing capacity.
Building on our successful regulatory interactions for the initial bioreactor process, we will continue to work with the regulators to determine the data necessary to demonstrate comparability of the product made with the larger scale Gen. Two process.
Including possibly even doing.
Clinical bridging work, so there'll be more information on that as we move forward.
Thank you Bridget.
And lastly, we've also received questions around our partnership discussions in licensing opportunities and I'll be happy to comment on this.
Previously the company engaged in licensing discussions with several well established pharmaceutical companies focused on countries outside the United States and primarily in Europe .
These discussions continue and will be influenced by upcoming data results.
As we further evaluate our overall business development strategy for Multistem, we will seek to reengage potential partners for stroke and other possible indications across any region, including the United States.
Thanks, everyone for those of you that submitted questions ahead of this call at this time, we would be happy to take questions from our analysts.
Thank you if you'd like to ask a question. Please press star followed by one on your telephone keypad.
Any reason you would like to remove that question. Please press <unk>.
Again to ask a question please star one.
A reminder.
Your phone please remember to pick up your handset before asking your question, we will call to briefly ask questions are registered.
The first question comes from Greg Harrison with Bofa Global Research. Please proceed.
Hi, guys. Good afternoon, thanks for taking the question.
So with respect to the cash runway.
It sounds like it would end in <unk> at current rates. So first is that accurate and if so what is the financing strategy.
Treasure data it doesn't lead to a near term partnership with an upfront payment.
It takes a bit sorry, yes, thanks, thanks Craig.
Yes.
With a run rate over the cash burn of between $17 million to $20 million of course, we do have the ability to.
Got it down but you are correct, we have enough to get to at least the end of the second quarter.
As I had mentioned, we do have access to our equity line, which could provide financing.
Yes.
The data does not lead to a successful partnership we have explored other means of financing.
Which I don't really want to give the details just yet we have not pulled the trigger on it but suffice to say we.
We have not so far access the debt markets.
There are other possibilities that we're exploring but our intention is to proceed with our discussions on the partnership and we do anticipate readouts deposits.
Got it and just as a quick follow up.
In your discussions that youre, having with potential partners.
Yes.
Is it feasible to have.
Deal struck within that sort of.
Period.
Or could they even be.
Under discussion now pending that data.
Just wanted to get a sense of when we could expect to see something.
If the data are positive.
When that could be announced.
Yes.
Great question, Greg as you know the largest pharma was slow and they move.
I can say is on the <unk> side with nimble, we moved very very quickly and we would like to combination as quickly as possible.
Our experience with the Big Pharma is lost due diligence teams. These types of things, even though we are down the path.
We expect it to be months.
But it's difficult to put a firm basis.
So the only thing I'll add Greg is we will be actively.
Looking at opportunities so the improbable before maybe the treasure data comes out, but we will be ramp.
Ramping up efforts to explore those opportunities.
Great. Thanks, again for taking the question.
Thank you. Thank you.
Thank you Greg. The next question comes from David Wong with SMB. Please proceed.
Hey, guys. Thanks for taking the questions and welcome to the company in World glad to have you aboard.
I just had a couple.
First one in terms of the potential partnership.
I think outlined it a little bit for us and it sounds like you are you are considering geographies broadly, but could you just give maybe a little bit more color as to.
With you at the helm now how do you kind of think about the ideal partner and.
What exactly are you looking for in the partnership what would constitute success from your point of view.
Sure, Yes happy to answer that David I think <unk>.
First our attention has been on making sure that our Helios partnership is a success and so a lot of work has been going in.
That partnership over the last year, and we will continue to look at ways for us to be successful, both both with stroke and <unk>.
I think outside of that we're going to take a step back and really look at all the areas that multistem may be appropriate. So we know we have a platform opportunity in multistem in and rather than just approaching it by looking at regions I think what we're going to do is undertake a process that.
Floors potentially.
Potentially other indications other uses.
Multistem.
With various partners and so.
It's not something that.
That we've.
We started right away, but it's something that we are going to be putting in place quickly.
Great. That's very helpful. Thank you for that and then I just wanted to ask in terms of.
Any.
Milestone payments from <unk> that we May we may expect this year do you expect to receive any for example, when the <unk> regulatory filings completed in Japan or on first commercialization of products in Japan.
Yes, yes.
Yes, yes.
David Thanks for the question, we haven't disclosed the specifics of milestone payments, but we do expect to receive milestone payments from Healy as this year based on our expectations for activities and development. So we can't really say much more than that but that is that's kind of built into how we think about that.
For the year.
Okay. I appreciate you sharing that thanks for taking the questions.
Thanks, Dave Thank you.
Thank you David.
Question comes from Gil Blum with Needham <unk> co. Please proceed.
Yes.
Hello, everyone and Hello again, Greg.
Have you on board.
First question.
Towards year so thank.
Considering your experiences in rare disease commercialization of horizon, we feel this translates well with multistem.
Submit more relevant in the Rds space, but.
Stroke is kind of a large indication if you can give some color on your experiences.
Sure.
Sure.
First kind of spans especially markets as well as rare disease I think I think it really depends on the therapeutic area that we'd be looking at for Multistem.
And the approach is essentially is taking a look at the market the available patient population and just kind of understanding.
What target market is most appropriate one.
One thing I will say to is theres been significant advancements in our manufacturing capabilities, which which we've highlighted on the call today that gives us a.
I think a significant advantage.
And so as we look at the available markets going forward and my experience with rare disease, I think we have an opportunity to engage.
Constituents in each market be it stroke or <unk> or even trauma in this case.
And make sure that <unk> in particular.
Is viewed as a potential treatment option with multistem and a partner in that space and so some of the activities that we would look at in rare disease, I think translate over well to what we're looking at for Multistem.
Alright. Thank you for the added color maybe another question here is there a potential for regularly Terry date for June .
Japan approvals versus U S. Usually the bar for approval in Japan is quite different than in the U S. So definitely envision a situation in which.
You will see Multistem improved.
Okay.
In stroke in Japan, but might not reach the same sort of bar. If you would expect for U S approval.
Yes.
Yes sure.
Yes.
It's an insightful question there is the possibility of some divergence between Japan, and the U S and for that matter some divergence between.
Japan and other jurisdictions in U S and other jurisdictions more generally.
It's true as you know I'm sure that in Japan, They have established phase.
Favorable regulation and laws with respect to regenerative medicine products and that might create some opportunities for approval of products that have not yet completed large scale pivotal efficacy studies we.
We see that as an opportunity for our partner he Oems we benefit from that if they are able to take advantage of those regulations.
We are confident though that.
The larger treasure study.
Is that a read out in a way that.
We hope we give them an opportunity for full approval, but you are right there could be some divergence we've spent quite a lot of time.
And trying to work across the geographies.
Led by our head of regulatory minimum Morrissey.
And making sure that we're approaching these things in a common way.
That the packages and information is developed in a common way that the studies that were running in the different geographies have relevance in the other geographies as well. So we're doing everything we can to.
To manage this across geographies to really optimize the outcome for us, but youre right on there could be some divergence at the end of the day with the Japan market, but we will take advantage of that and I think our partner would benefit as well.
Okay excellent. Thank you for providing some clarity on that then.
Congrats on your progress.
Thank you <unk>.
Yeah.
Thank you Jill.
This concludes our Q&A and I will now turn it over to Dan for closing remarks.
Thank you very much and thank you all for listening to our earnings call. We value your support of the company and we are looking forward to a very exciting year ahead in 2020.
Thank you very much.
Two.
That concludes that there since year end 2021 results conference call. Thank you for your participation you may now disconnect your lines.
Okay.