dave
Junior Member
Posts: 87
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Post by dave on Jun 27, 2016 23:24:41 GMT
on stocktwit folks are talking about a buyout
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Post by avtech on Jun 28, 2016 0:34:59 GMT
This is one of my two favorite companies. I would not be surprised to see Caladrius receive an offer. The recent 8k clearly suggests it is a serious consideration acted upon by the principle officers of the company. 8k(e):"The severance payments described below are only payable upon the occurrence of a so-called "double-trigger" after a change of control. Accordingly, the benefits will be available if the officer is terminated or his position is reduced after such change of control."
Not to say it will happen any time soon. Just that it is clearly a consideration.
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Post by selluwud on Jun 30, 2016 14:00:59 GMT
Any news here? Nice volume this morning and up 25%
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Post by jckrdu on Jun 30, 2016 15:06:53 GMT
Any news here? Nice volume this morning and up 25% Not sure if the move is related to Kiadis' PR this morning. CLBS does their manufacturing...
Kiadis Pharma’s Orphan Drug Designation for ATIR101™ further expanded to include treatment in a hematopoietic stem cell transplantation
Amsterdam, The Netherlands, June 30, 2016 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company developing innovative T-cell immunotherapy treatments for blood cancers and inherited blood disorders, today announces that its lead product, ATIR101™, has been granted an expansion to its existing Orphan Drug Designation (ODD) by the European Medicines Agency (EMA) to include treatment in a hematopoietic stem cell transplantation (HSCT).
Kiadis Pharma was previously granted an ODD for ATIR101™ by both EMA and the United States Food and Drug Administration (FDA) for the prevention of Graft-versus-Host-Disease (GVHD) following an allogeneic HSCT. A further ODD was granted by the FDA for the prevention of Transplant Related Mortality following an allogeneic HSCT and a fourth ODD was granted by EMA for the treatment of acute myeloid leukemia (AML) following an allogeneic HSCT. This latter ODD has now been expanded by EMA to cover all uses of ATIR101™ as treatment in HSCT, regardless of the underlying disease.
Manfred Rüdiger, PhD, Chief Executive Officer of Kiadis Pharma, commented: “This expanded Orphan Drug Designation in the European Union for our lead product ATIR101™ attests to the understanding and belief that ATIR101™ could be used in the context of a hematopoietic stem cell transplantation independent of the underlying disease. Therefore its use in, for example, chronic lymphocytic leukemia (CLL) and chronic myeloid leukemia (CML), amongst many other diseases, is now also covered by this newly issued ODD. We believe this extension to the ODD significantly strengthens our value proposition for ATIR101™ and will also make this potentially lifesaving therapy available to even more people in desperate need of a transplant.”
The EMA’s ODD is reserved for new therapies being developed to treat life-threatening or chronically debilitating diseases or conditions that are relatively rare in the European Union and for which no satisfactory therapy is available. The ODD designation provides incentives to support development, including fee reductions and a ten-year period of market exclusivity in the European Union after product approval.
About ATIR101™
For patients suffering from blood cancers, an allogeneic hematopoietic stem cell transplantation (HSCT) is generally regarded as the most effective curative approach. During an HSCT treatment, the bone marrow, harboring the diseased cancer cells, is completely destroyed and subsequently replaced by stem cells in the graft from a healthy donor. After an HSCT treatment it usually takes the patient at least six to twelve months to recover to near-normal blood cell levels and immune cell functions. During this period, the patient is highly vulnerable to infections caused by bacteria, viruses and fungi but also to disease relapse.
ATIR101™ (Allodepleted T-cell ImmunotheRapeutics) provides for a safe donor lymphocyte infusion (DLI) from a partially matched (haploidentical) family member without the risk of causing severe Graft-versus-Host-Disease (GVHD). The T-cells in ATIR101™ will help fight infections and remaining tumor cells and thereby bridge the time until the immune system has fully re-grown from stem cells in the transplanted graft.
In ATIR101™, T-cells that would cause GVHD are eliminated from the donor lymphocytes using Kiadis Pharma’s photodepletion technology, minimizing the risk of GVHD and eliminating the need for prophylactic immune-suppression. At the same time, ATIR101™ contains potential cancer killing T-cells from the donor that could eliminate residual cancer cells and help prevent relapse of the disease, known as the Graft-versus-Leukemia (GVL) effect.
Therefore, ATIR101™, administered as an adjunctive immuno-therapeutic on top of HSCT, provides the patient with functional, mature immune cells from a partially matched family donor that can fight infections and tumor cells but that do not cause GVHD. ATIR101™ thus has the potential to make curative HSCT a viable option to many more patients.
The Company estimates that approximately 35% of patients who are eligible and in urgent need of HSCT will not find a matching donor in time. A partially matched (haploidentical) family donor, however, will be available to over 95% of patients.
ATIR101™, consisting of donor T-cells that fight infections and residual tumor cells while not eliciting severe GVHD, is designed to result in low relapse rates and low rates of death due to infections, in the absence of severe acute GVHD.
About Kiadis Pharma
Kiadis Pharma is focused on cell-based immunotherapy products for the treatment of blood cancers and inherited blood disorders. The Company’s products have the potential to address the risks and limitations connected with allogeneic hematopoietic stem cell transplantation (HSCT), namely Graft-versus-Host-Disease (GVHD), cancer relapse, opportunistic infections and limited matched donor availability. The Company believes that HSCT could become a first-choice treatment for blood cancers, inherited blood disorders and possibly autoimmune diseases and solid organ transplantations.
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Post by selluwud on Jun 30, 2016 15:21:35 GMT
Any news here? Nice volume this morning and up 25% Not sure if the move is related to Kiadis' PR this morning. CLBS does their manufacturing...
Kiadis Pharma’s Orphan Drug Designation for ATIR101™ further expanded to include treatment in a hematopoietic stem cell transplantation
Amsterdam, The Netherlands, June 30, 2016 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company developing innovative T-cell immunotherapy treatments for blood cancers and inherited blood disorders, today announces that its lead product, ATIR101™, has been granted an expansion to its existing Orphan Drug Designation (ODD) by the European Medicines Agency (EMA) to include treatment in a hematopoietic stem cell transplantation (HSCT).
Kiadis Pharma was previously granted an ODD for ATIR101™ by both EMA and the United States Food and Drug Administration (FDA) for the prevention of Graft-versus-Host-Disease (GVHD) following an allogeneic HSCT. A further ODD was granted by the FDA for the prevention of Transplant Related Mortality following an allogeneic HSCT and a fourth ODD was granted by EMA for the treatment of acute myeloid leukemia (AML) following an allogeneic HSCT. This latter ODD has now been expanded by EMA to cover all uses of ATIR101™ as treatment in HSCT, regardless of the underlying disease.
Manfred Rüdiger, PhD, Chief Executive Officer of Kiadis Pharma, commented: “This expanded Orphan Drug Designation in the European Union for our lead product ATIR101™ attests to the understanding and belief that ATIR101™ could be used in the context of a hematopoietic stem cell transplantation independent of the underlying disease. Therefore its use in, for example, chronic lymphocytic leukemia (CLL) and chronic myeloid leukemia (CML), amongst many other diseases, is now also covered by this newly issued ODD. We believe this extension to the ODD significantly strengthens our value proposition for ATIR101™ and will also make this potentially lifesaving therapy available to even more people in desperate need of a transplant.”
The EMA’s ODD is reserved for new therapies being developed to treat life-threatening or chronically debilitating diseases or conditions that are relatively rare in the European Union and for which no satisfactory therapy is available. The ODD designation provides incentives to support development, including fee reductions and a ten-year period of market exclusivity in the European Union after product approval.
About ATIR101™
For patients suffering from blood cancers, an allogeneic hematopoietic stem cell transplantation (HSCT) is generally regarded as the most effective curative approach. During an HSCT treatment, the bone marrow, harboring the diseased cancer cells, is completely destroyed and subsequently replaced by stem cells in the graft from a healthy donor. After an HSCT treatment it usually takes the patient at least six to twelve months to recover to near-normal blood cell levels and immune cell functions. During this period, the patient is highly vulnerable to infections caused by bacteria, viruses and fungi but also to disease relapse.
ATIR101™ (Allodepleted T-cell ImmunotheRapeutics) provides for a safe donor lymphocyte infusion (DLI) from a partially matched (haploidentical) family member without the risk of causing severe Graft-versus-Host-Disease (GVHD). The T-cells in ATIR101™ will help fight infections and remaining tumor cells and thereby bridge the time until the immune system has fully re-grown from stem cells in the transplanted graft.
In ATIR101™, T-cells that would cause GVHD are eliminated from the donor lymphocytes using Kiadis Pharma’s photodepletion technology, minimizing the risk of GVHD and eliminating the need for prophylactic immune-suppression. At the same time, ATIR101™ contains potential cancer killing T-cells from the donor that could eliminate residual cancer cells and help prevent relapse of the disease, known as the Graft-versus-Leukemia (GVL) effect.
Therefore, ATIR101™, administered as an adjunctive immuno-therapeutic on top of HSCT, provides the patient with functional, mature immune cells from a partially matched family donor that can fight infections and tumor cells but that do not cause GVHD. ATIR101™ thus has the potential to make curative HSCT a viable option to many more patients.
The Company estimates that approximately 35% of patients who are eligible and in urgent need of HSCT will not find a matching donor in time. A partially matched (haploidentical) family donor, however, will be available to over 95% of patients.
ATIR101™, consisting of donor T-cells that fight infections and residual tumor cells while not eliciting severe GVHD, is designed to result in low relapse rates and low rates of death due to infections, in the absence of severe acute GVHD.
About Kiadis Pharma
Kiadis Pharma is focused on cell-based immunotherapy products for the treatment of blood cancers and inherited blood disorders. The Company’s products have the potential to address the risks and limitations connected with allogeneic hematopoietic stem cell transplantation (HSCT), namely Graft-versus-Host-Disease (GVHD), cancer relapse, opportunistic infections and limited matched donor availability. The Company believes that HSCT could become a first-choice treatment for blood cancers, inherited blood disorders and possibly autoimmune diseases and solid organ transplantations.
Very likely that it could be. Nice catch, the PR involving PCT was just done on the 21st of this month.
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dave
Junior Member
Posts: 87
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Post by dave on Jul 2, 2016 18:45:41 GMT
it seems like they've they're share of good and bad news lately with pct. kite for example stated they will move to do their own cell manufacture. i imagine that any company starting to commercialize will consider doing the same.
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dave
Junior Member
Posts: 87
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Post by dave on Jul 6, 2016 16:50:15 GMT
recent insider sales by Wei, don't bode well for the idea of takeover candidate. on a more positive note looks like they have finished enrolling their first cohort for stanford trex diabetes type 1 study and data should be disclosed by end of summer. clbs stated intention was to publish good data and partner. this study gets a lot of press, so i think that is feasible.
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Post by morangie777 on Jul 6, 2016 22:12:28 GMT
It may be far fetched but who knows.
Just out today. maybe contributing to todays drop in CLBS pps? Kite about doubles (Afaik) their El Segundo facility space. It appears it is just office space this time, but shows their commitment to their El Segundo manufacturing site. CLBS management has sometimes alluded that we should see a boost for PCT when its customers reach commercial stage. In the case of Kite at least I am not so sure about it.
I am excited about the potential of the Diabetes trial but am uncertain what to think about the future of the PCT business.
From Kites 8K Quote: Entry into a Material Definitive Agreement, Financial Statements and Exhibits
Item 1.01 Entry into a Material Definitive Agreement.
On July 1, 2016, Kite Pharma, Inc. ("Kite") entered into a Lease Agreement (the "Lease") with 2383 Utah, LLC, for the lease of approximately 60,000 square feet of primarily office space in El Segundo, which is adjacent to Kite's manufacturing facility. The Lease has a nine year and six month term commencing on February 1, 2017. Upon certain conditions, Kite has two options to extend the Lease, each for an additional five years. Kite paid $176,400 upon execution of the Lease and is required to remit base rent of $176,400 per month, or $2.94 per square foot, which will increase at a rate of approximately 3% per year. The monthly installments will be abated for the months of February 2017, February 2018, February 2019, February 2020, February 2021, February 2022 and February 2023.
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Post by morangie777 on Jul 27, 2016 15:43:00 GMT
So 1:10 it is. Tomorrow. Good, bad, ugly?
Will be interesting to see.
I am still watching this one closely and may open a position later in 2016, in anticipation of interim results from the Diabetes study. But not sure how and when anything will be made public.
From the last 10Q :
In the first quarter of 2016 we commenced patient enrollment in the first of two cohorts in The Sanford Project: T-Rex Study, a Phase 2 prospective, randomized, placebo-controlled, double-blind clinical trial to evaluate the safety and efficacy of our Treg product candidate, CLBS03, in adolescents with recent onset T1D. After the three-month follow-up of the first cohort of 18 patients, which is expected in early 2017, an initial safety analysis of the data and early analysis of immunological biomarkers will be undertaken. Satisfactory evaluation of the safety of the initial cohort as agreed by us, our independent Data Safety Monitoring Board and the U.S. Food and Drug Administration ("FDA") will then prompt the enrollment of the remaining 93 patients. A subsequent interim analysis of efficacy is planned after approximately 50% of patients reach the six-month follow- up milestone.
2017? Or already something in 2016? Thoughts? Good luck and Cheers!
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Post by jckrdu on Jul 27, 2016 16:28:25 GMT
So 1:10 it is. Tomorrow. Good, bad, ugly? Will be interesting to see. I am still watching this one closely and may open a position later in 2016, in anticipation of interim results from the Diabetes study. But not sure how and when anything will be made public. From the last 10Q : In the first quarter of 2016 we commenced patient enrollment in the first of two cohorts in The Sanford Project: T-Rex Study, a Phase 2 prospective, randomized, placebo-controlled, double-blind clinical trial to evaluate the safety and efficacy of our Treg product candidate, CLBS03, in adolescents with recent onset T1D. After the three-month follow-up of the first cohort of 18 patients, which is expected in early 2017, an initial safety analysis of the data and early analysis of immunological biomarkers will be undertaken. Satisfactory evaluation of the safety of the initial cohort as agreed by us, our independent Data Safety Monitoring Board and the U.S. Food and Drug Administration ("FDA") will then prompt the enrollment of the remaining 93 patients. A subsequent interim analysis of efficacy is planned after approximately 50% of patients reach the six-month follow- up milestone.
2017? Or already something in 2016? Thoughts? Good luck and Cheers! Recent comments by the CEO indicated that diabetes enrollment was going faster than planned, and that results on the first 18 patients may be ready in late 2016.
I bought some this morning on the pullback after the reverse split news was released. Still lots of risk here given their cash position (approximately 12 months cash I believe), but like most companies, they're likely timing the reverse split with news coming on the other side. Decent chance we see some type of news soon after the reverse is effective tomorrow (7/28), which could be a partnership in Japan for CLI and/or Hitachi partnership news for the EU.
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Post by morangie777 on Jul 27, 2016 17:37:22 GMT
So 1:10 it is. Tomorrow. Good, bad, ugly? Will be interesting to see. I am still watching this one closely and may open a position later in 2016, in anticipation of interim results from the Diabetes study. But not sure how and when anything will be made public. From the last 10Q : In the first quarter of 2016 we commenced patient enrollment in the first of two cohorts in The Sanford Project: T-Rex Study, a Phase 2 prospective, randomized, placebo-controlled, double-blind clinical trial to evaluate the safety and efficacy of our Treg product candidate, CLBS03, in adolescents with recent onset T1D. After the three-month follow-up of the first cohort of 18 patients, which is expected in early 2017, an initial safety analysis of the data and early analysis of immunological biomarkers will be undertaken. Satisfactory evaluation of the safety of the initial cohort as agreed by us, our independent Data Safety Monitoring Board and the U.S. Food and Drug Administration ("FDA") will then prompt the enrollment of the remaining 93 patients. A subsequent interim analysis of efficacy is planned after approximately 50% of patients reach the six-month follow- up milestone.
2017? Or already something in 2016? Thoughts? Good luck and Cheers! Recent comments by the CEO indicated that diabetes enrollment was going faster than planned, and that results on the first 18 patients may be ready in late 2016.
I bought some this morning on the pullback after the reverse split news was released. Still lots of risk here given their cash position (approximately 12 months cash I believe), but like most companies, they're likely timing the reverse split with news coming on the other side. Decent chance we see some type of news soon after the reverse is effective tomorrow (7/28), which could be a partnership in Japan for CLI and/or Hitachi partnership news for the EU.
I really wish that for you. as an anecdote, a recent Reverse Split by STEM was followed by awful news. Went from 30c, to $3 after split, then back down to 30c in a matter of 2 weeks. As bad as I have ever seen it. Clearly the same is not going to happen to CLBS, but just an example how wrong it can go.
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Post by harleyquinn on Jul 28, 2016 12:04:27 GMT
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Post by selluwud on Jul 28, 2016 12:17:47 GMT
I bought some as well Jckrdu and here's the beginning of the PR's you predicted. Nice call.
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Post by jckrdu on Jul 28, 2016 12:35:41 GMT
I bought some as well Jckrdu and here's the beginning of the PR's you predicted. Nice call. Thanks Sell. Not sure how much of a move we're going to see on this Fast-Track news, but it should help put a floor in at a minimum. I'm going to continue to hold for partnership news for their critical limb ischemia program in Japan, which should be coming soon and should have a larger impact. Still risk here as they'll likely need to raise more cash sometime in 2016.
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Post by selluwud on Jul 28, 2016 13:04:18 GMT
I bought some as well Jckrdu and here's the beginning of the PR's you predicted. Nice call. Thanks Sell. Not sure how much of a move we're going to see on this Fast-Track news, but it should help put a floor in at a minimum. I'm going to continue to hold for partnership news for their critical limb ischemia program in Japan, which should be coming soon and should have a larger impact. Still risk here as they'll likely need to raise more cash sometime in 2016. With a raise sure to come, I will try to get out when the gettins' good.
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Post by jckrdu on Jul 28, 2016 16:02:18 GMT
Added at $5.20.
IMO, capital raise is more likely to come after CLI news in Japan, and interim diabetes results.
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dave
Junior Member
Posts: 87
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Post by dave on Jul 29, 2016 15:24:15 GMT
Added at $5.20. IMO, capital raise is more likely to come after CLI news in Japan, and interim diabetes results. what sp range are you expecting after CLI and diabetes news?
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Post by jckrdu on Jul 29, 2016 16:41:19 GMT
Added at $5.20. IMO, capital raise is more likely to come after CLI news in Japan, and interim diabetes results. what sp range are you expecting after CLI and diabetes news? Lots of moving parts, including the likely need for an additional capital raise. My thoughts...
In the near-term, my hope is that they close the CLI partnership in Japan and it comes with at least $10M of upfront cash. IMO, the pps should see at least a 50% move on that news, as its only a $32M market cap at $5.50 pps. With $10M upfront cash, that'll take the need for near-term dilution off the table, and will enable them to get past the diabetes interim data readout (1st 18 patients) later this year without having to raise more capital. Good interim diabetes results should then take it even higher... maybe to a $75M+ market cap, which is twice the current valuation. Hitachi EU partnership news is a wildcard.
A lot depends on when they raise capital. It wouldn't surprise me to see them raise capital at any time, but per my prior post, its more likely that they wait until after more good news. In the last call, the CEO expressed his frustration with the current $30M market cap, when Hitachi just valued the PCT business alone at $100M. Hard for me to see the CEO do any kind of major capital raise now, when he has $15M cash on-hand and a $30M+ credit line with Aspire. But, anythings possible.
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Post by jckrdu on Jul 29, 2016 16:43:53 GMT
what sp range are you expecting after CLI and diabetes news? Lots of moving parts, including the likely need for an additional capital raise. My thoughts...
In the near-term, my hope is that they close the CLI partnership in Japan and it comes with at least $10M of upfront cash. IMO, the pps should see at least a 50% move on that news, as its only a $32M market cap at $5.50 pps. With $10M upfront cash, that'll take the need for near-term dilution off the table, and will enable them to get past the diabetes interim data readout (1st 18 patients) later this year without having to raise more capital. Good interim diabetes results should then take it even higher... maybe to a $75M+ market cap, which is twice the current valuation. Hitachi EU partnership news is a wildcard.
A lot depends on when they raise capital. It wouldn't surprise me to see them raise capital at any time, but per my prior post, its more likely that they wait until after more good news. In the last call, the CEO expressed his frustration with the current $30M market cap, when Hitachi just valued the PCT business alone at $100M. Hard for me to see the CEO do any kind of major capital raise now, when he has $15M cash on-hand and a $30M+ credit line with Aspire. But, anythings possible.
Bigger PPS moves (market cap over $100M) will likely come only after they increase revenue/profit guidance for 2017, and demonstrate they're on firm financial footing. With the Kiadis deal closed, that PR should be coming in late 2016.
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Post by jckrdu on Aug 10, 2016 16:42:05 GMT
I added a little more this morning between $6.25 - $6.30 after yesterday's conference call. I have a relatively small position as there are risks. My notes/thoughts after listening to the call...
- They're moving in the right direction; increasing revenues and decreasing costs for PCT division. - Biggest risk/concern is their low cash position of only $17M - They're projecting to burn through another $14M of cash from now until end of year, leaving only $3M cash balance. In my opinion, the CEO is not going to let the cash balance get that low, so more cash must come in via partnerships or dilution in the next 1-4 months. (They do have a line of credit of close to $30M they can use as a short-term bridge, so a capital raise isn't necessarily imminent.) - So why did I buy more with them in a precarious cash position? It's a risk, but, I have a relatively small position, and... - Current market cap is only $36M at $6.30 pps. - The recent Hitachi investment of $20M for 20% of PCT valued PCT alone at $100M in value. - Given the above, I don't believe the CEO will raise cash via dilution at the current $36M market cap (Of course he could.) - In my opinion, most likely path forward is that some type of major good news is announced (Japan partnership for CLI is my guess, or Hitachi deal for EU), to get the pps higher before raising more capital via dilution - In my opinion, they'll raise more cash via an equity offering after the above occurs.
Therefore, my plan is to hold and add maybe a little more on any dips, until I see some good news, at which point I'll exit my position as I believe a capital raise is likely coming soon afterwards.
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