Stem Cell Clinic

Edited Transcript of FLXN earnings conference call or presentation 12-Mar-20 8:30pm GMT – Yahoo Finance

By Gene Therapy Clinics

Woburn Mar 16, 2020 (Thomson StreetEvents) -- Edited Transcript of Flexion Therapeutics Inc earnings conference call or presentation Thursday, March 12, 2020 at 8:30:00pm GMT

* David A. Arkowitz

Flexion Therapeutics, Inc. - CFO

* Michael D. Clayman

Flexion Therapeutics, Inc. - Co-Founder, President, CEO & Director

Flexion Therapeutics, Inc. - VP of Corporate Communications & IR

The Benchmark Company, LLC, Research Division - Senior Healthcare Technology Research Analyst

Joh. Berenberg, Gossler & Co. KG, Research Division - Analyst

* Serge D. Belanger

Good afternoon, ladies and gentlemen. And welcome to the Flexion Therapeutics Fourth Quarter and Full Year 2019 Financial Results Conference Call. My name is Daniel, and I will be your coordinator for today. (Operator Instructions)

I'll now turn the call over to the company.

Scott Young, Flexion Therapeutics, Inc. - VP of Corporate Communications & IR [2]

Thank you, Dan. Good afternoon. This is Scott Young, Vice President for Corporate Communications and Investor Relations. Before we begin, I would call your attention to the metrics slide that we will discuss in today's presentation. Those slides can be viewed directly via the webcast, in the 8-K we issued this afternoon or under the Investors tab on flexiontherapeutics.com.

In addition, our Q4 earnings press release and an archive of this conference call, can also be found there. Today's call will be led by Flexion's Chief Executive Officer, Dr. Michael Clayman; and he is joined by David Arkowitz, Flexion's Chief Financial Officer; and Melissa Layman, Flexion's newly appointed Chief Commercial Officer.

On today's call, we will be making forward-looking statements that include commercial, financial, clinical and regulatory projections. Statements relating to future financial or business performance, conditions or strategies

matters, including expectations regarding net sales, operating expenses, cash utilization, clinical, regulatory and commercial developments and anticipated milestones are forward-looking statements within the meaning of the Private Securities Litigation Reform Act.

Flexion cautions that these forward-looking statements are subject to various assumptions, risks and uncertainties, which change over time. Additional information on the factors and risks that could affect Flexion's business, financial conditions and results of operations are contained in Flexion's Form 10-K for the year ended December 31, 2019, which was filed with the SEC and other filings, which are available at http://www.sec.gov as well as Flexion's website.

These forward-looking statements speak only as of the date of this call, and Flexion assumes no duty to update such statements. I will now turn the call over to Flexion's CEO, Mike Clayman.

Michael D. Clayman, Flexion Therapeutics, Inc. - Co-Founder, President, CEO & Director [3]

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Thanks, Scott, and thank you all for joining. Today, I'll recap our commercial progress in 2019, review our life cycle management activities, provide an update on our pipeline and discuss our priorities for this year. After that, I'll turn it over to David for a deeper review of our commercial metrics and a summary of our financial performance, and then we will open the line and take questions.

To begin, as we reported today, we recorded full year ZILRETTA net sales of $73 million for 2019, which is fully in line with the preliminary unaudited revenue estimate we provided in early January. We are very pleased with our sales performance in 2019, which represents growth of more than 220%, compared to our 2018 full year net sales of $22.5 million. Those numbers tell a very compelling story, and they speak to the outstanding work of our field-based teams, the excellent coverage we have for ZILRETTA, the impact from our judicious use of volume-based rebates, but most importantly, our sales performance speaks to the remarkable experience that patients and clinicians are having with ZILRETTA. As you will see in the commercial metrics that David will review, by the end of 2019, our customers had purchased 175,000 units of ZILRETTA. While our data are limited to the account level, that number provides a reasonable surrogate for the number of patients who have been treated with ZILRETTA since it was introduced to the market in late 2017. And we know that many of those patients have received unprecedented pain relief from ZILRETTA. I say this based on real-world feedback from the countless conversations I've had with grateful ZILRETTA patients and their physicians, feedback that is wholly consistent with our compelling clinical trial data.

In fact, last year, we became aware of several professional athletes who received ZILRETTA, namely Rod Woodson, the NFL Hall of Fame Defensive back named as one of the top 100 players of all time. Michael Eruzione, the captain of the 1980 Gold medal winning U.S. Olympic Hockey team and the player who scored the game winning goal against the Russians during the Miracle On Ice; and Chris Dickerson, a former outfielder who played from the New York Yankees and other major league baseball teams. From snow blowing a driveway to playing with their children and grandchildren, to jogging for the first time in years, they all have profoundly moving stories about how ZILRETTA has helped each of them manage their knee OA pain, and thereby, improve their ability to participate in regular everyday activities. As part of our ongoing physician marketing initiatives, we brought all 3 athletes together at a major orthopedic conference last December, where they and their treating physicians, spoke to a standing room crowd of some of the country's leading sports medicine experts. They shared their stories of how ZILRETTA has helped them, and the best words I can use to describe that session are inspiring and humbling.

While all are elite athletes, their ZILRETTA stories echo the scores of e-mails and letters I've received from patients who are so grateful to reengage in things they love doing with less pain. From gardening, playing a round of golf, walking on the beach, hiking, each of these stories serves as a reminder to all of us that while we have impacted more than 175,000 patients, there are 15 million people who see their doctor every year for OA knee pain. And 5 million of them receive an intra-articular injection. The opportunity for ZILRETTA and Flexion is truly massive, which brings me back to our performance in 2019 and our goals for 2020.

Throughout the course of 2019, we saw existing practices increase their use of ZILRETTA and more than 1,600 new accounts start using the product. Today, with the benefit of 2 years in the market, we have actual claims [data that show some slight] (added by company after the call) changes in the payer mix versus our assumptions prior to launch. We now see that the actual payer mix is skewed slightly more toward Medicare, which accounts for roughly 55% of the market versus previous estimates of 50%. 40% is still commercial, but Medicaid, VA and 340B plans are making up roughly 5% of the mix. We view this modest increase in Medicare patients to be incrementally positive as Medicare patients can be injected the same-day they visit without any need for prior authorization. In addition, it is important to point out that commercial coverage for ZILRETTA remains excellent. As we discussed in December, the recent approval of our sNDA resulted in a significantly improved label, which most importantly, removed the onerous not intended for repeat administration wording in the limitation of use statement. Within days of the approval, we developed materials to help our MBMs communicate the label update and we have anecdotal feedback from the field that tells us that the changes have been very well received. While we clearly view the label update as a tailwind. We have always said that we continue to believe that the meaningful impact will be seen over the following quarters and years. From a commercial perspective, our progress in 2019 strengthens our belief that ZILRETTA can become the new standard of care for the intra-articular treatment for OA knee pain in the years ahead. While under normal circumstances, these factors would give us confidence that our 2020 ZILRETTA net sales guidance of $120 million to $135 million is both credible and achievable. Like all businesses, we are acutely attuned to the potential impacts of the coronavirus global pandemic, and we are monitoring this dynamic situation very closely. To date, we have not seen any material impacts on ZILRETTA sales, our ability to access customers or to initiate our clinical trials. However, it is impossible to predict how the outbreak could evolve in the months ahead or what impacts more aggressive social distancing or other containment efforts might have on patients or practices. Regarding our supply chain, we believe we are in a very strong position. We do not source any of our key materials from China, and we presently have approximately 10 months worth of finished product inventory in our warehouses in the U.S. Furthermore, we have an additional 12 months of API, triamcinolone acetonide at our manufacturing facility in the U.K. Again, it is impossible to predict the long-term impacts of the outbreak. But we feel very good about our ability to provide ZILRETTA to patients over the quarters ahead.

Shifting to our clinical development activities, our Phase II trial to investigate the safety and efficacy of ZILRETTA in shoulder OA and adhesive capsulitis, also known as frozen shoulder syndrome continues to advance, and we anticipate data from that trial in 2021.

As we've previously discussed, these 2 conditions combined account for roughly 800,000 injections, and they present an opportunity for us to expand the use of ZILRETTA with a subset of orthopedists, who primarily focus on sports medicine and commonly treat these conditions with steroid injections.

With respect to our pipeline, we've also been making progress with our 2 drug candidates, FX201 and FX301. FX201 is our gene therapy, which holds the potential to provide OA pain relief for at least a year, improve function and potentially modify disease. As we announced last year, the IND for FX201 was accepted by the FDA, and we recently treated the first 2 patients in our Phase I dose-ranging study. We anticipate treating approximately 15 to 24 patients, who will be followed for 104 weeks with initial readout in 2021.

Now we'll move to FX301. Our NAV 1.7 inhibitor, formulated within a thermosensitive hydrogel for administration as a peripheral nerve block for control of postoperative pain. We've held our pre-IND meeting with FDA, and we remain on track to initiate our first FX301 clinical trial in 2021.

Unlike typical local anesthetics, we believe the selective pharmacology of FX301 has the potential to deliver at least 3 to 5 days of effective pain relief, while preserving motor function, which could enable ambulation, rapid discharge from the hospital and early rehabilitation following musculoskeletal surgery.

Finally, regarding our search for a Chief Commercial Officer. We were very excited to announce the appointment of Melissa Layman earlier this week, and I'm delighted that she is able to join us for today's call. As we've said repeatedly, in our search for a CCO, we were looking for someone who had had success leading an entire commercial enterprise, who had deep experience and expertise in each of the key commercial functional domains, who had a track record as a very strong leader and who would positively contribute to our already strong culture. Because Melissa fulfills all of these criteria and is simply a terrific person to interact with. We could not be more pleased to have her take the helm of our commercial organization. Before David summarizes our fourth quarter financials and walks through the commercial metrics, I'd like to give Melissa the opportunity to make a few remarks. Melissa?

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Melissa Layman, [4]

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Thank you, Mike, and thank you for the kind words. It is such a pleasure to be here today and such an honor to join Flexion. While I've barely been in my role for a day, I can already see what an amazing group of people work here. The team has been welcoming, engaging and candid, and that was consistent throughout the entire interview process from the Executive Committee to the Board members. The commitment to patients and passion for winning has been universal, and that was one of the many reasons I wanted to join. Put simply, I can't begin to convey how excited I am about the opportunity that's ahead of us. The strong foundation that's been laid by Mike, David, Steve Meyers, and the rest of the commercial leadership team is truly impressive, and I'm looking forward to working together to grow ZILRETTA's market share and help make it the leading IA treatment in this space. Over the next few months, I'll be working intensively with our commercial organization, and I look forward to representing our commercial effort on future calls. At this point, I'll turn it over to David.

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David A. Arkowitz, Flexion Therapeutics, Inc. - CFO [5]

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Thank you, Melissa. I'll start by walking through our commercial metrics which, as Scott mentioned, can be found on our website and in the 8-K we issued today.

If you look at Slide 2, you can see that we recorded ZILRETTA net sales of $23.7 million in the fourth quarter of 2019, bringing full year 2019 net sales to $73 million. As Mike mentioned, year-over-year growth topped [220%] (corrected by company after the call). As in previous quarters, we expanded our list of target accounts in the fourth quarter to 4,972, and by December 31, 2019, we've called on almost all of them. At the end of the fourth quarter, 3,488 accounts had purchased ZILRETTA, which is an increase of nearly 360 purchasing accounts compared to the end of the third quarter.

As of the end of December, we had 2,642 accounts or 76% of all purchasing accounts place at least 1 reorder for ZILRETTA. Notably, we saw our reorder rate increase in each quarter throughout 2019, and this occurred on a successively growing customer base. Slide 3 charts our quarterly sales from launch through the fourth quarter of 2019, which provides a very compelling view of ZILRETTA's growth in the market, especially since the introduction of the permanent J Code on January 1, 2019. We do not provide quarterly guidance, but based on routine seasonality impacts, directionally, we anticipate first quarter net sales to be roughly flat versus the fourth quarter of last year.

Moving to Slide 4. This slide and the remaining 2 slides reflect purchases of ZILRETTA by accounts, which represent physician practices, clinics and hospitals of various sizes and purchasing potential. As we look at the distribution of accounts that have purchased ZILRETTA since launch, we stayed with the same groupings that we've used in previous quarters, accounts that have purchased 1 to 10 units, purchased 11 to 50 units or purchased more than 50 units. We continue to see a significant number of accounts with purchases of 1 to 10 units. And as of December 31, 2019, roughly 1,670 accounts had made purchases in this range. While approximately 1,030 accounts had purchased 11 of 50 units. In addition, 794 accounts had purchased more than 50 units, which represents growth of 150% as compared to Q1 2019 when 313 accounts had purchased in this category.

Looking at Slide number 5. You can clearly see the distribution of purchases by accounts. Those 794 accounts that have each purchased more than 50 units are in total, responsible for approximately 143,000 units or roughly 81% of all units purchased since launch. As we have mentioned previously, accounts generally move along a utilization continuum from 1 to 10 units to 11 to 50 units and then to more than 50 units. Importantly, none of our purchasing accounts has fully incorporated ZILRETTA into their practice. And this holds true for even the highest utilizers. As a result, we believe there is tremendous opportunity for us to increase utilization across each of these groups. Before I leave this slide, I would like to point out that the total ZILRETTA purchases by accounts in the fourth quarter were approximately 37,500 units, which is lower than the 48,600 units purchased in the third quarter. We believe this quarter-over-quarter reduction was primarily the result of the broad-based rebate program that we introduced in the third quarter. There was a strong amount of enthusiasm and pent-up demand for this program, and we believe that some purchases that otherwise would have occurred in the fourth quarter instead occurred in the third quarter. To a much lesser extent, we believe that the holidays in the fourth quarter had an impact on the sequential quarter reduction as well. Nevertheless, we saw total ZILRETTA purchases by accounts increased by more than 70% in the second half of 2019 versus the first half of 2019.

Moving to Slide 6. Here, we break out ZILRETTA purchases by new and existing accounts. And in the fourth quarter, we added about 350 new purchasing accounts. While we expect to eventually see a slowing in the number of new accounts coming on board each quarter, we continue to be pleased with the progress we are making with new accounts as they typically work their way through the ZILRETTA utilization continuum.

So at this point, I will briefly walk through the fourth quarter and full year 2019 financial results, which we included in the press release issued this afternoon and in our 10-K. We reported a net loss of $149.8 million for full year 2019 as compared to a net loss of $169.7 million for full year 2018. Net sales of ZILRETTA were $23.7 million for the fourth quarter of 2019 and totaled $73 million for full-year 2019. The cost of sales for full-year 2019 was $10 million. The fourth quarter 2019 net sales reflect a gross to net reduction of 11%. A gross to net reduction is primarily comprised of distributor and service fees, returns reserve, health care provider rebates and mandatory government discounts and rebates, such as Medicaid, 340B institutions, and Veterans Administration, Department of Defense. As we previously mentioned, in the third quarter, we started offering rebates to eligible health care providers that are variable based on the volume of product purchased. These provider rebates contributed 4% of the fourth quarter total gross to net reduction of 11%. Research and development expenses were $69.6 million, and $53.1 million for the years ended December 31, 2019 and 2018, respectively. The increase in research and development expenses year-over-year of $16.5 million was primarily due to an increase in salary and other related costs for additional headcount and stock-based compensation expense, an increase in expenses related to portfolio expansion and other program costs, including an upfront payment to Xenon Pharmaceuticals related to FX301, and an increase in development expenses for ZILRETTA. Selling, general and administrative expenses were $129.7 million and $121.3 million for the years ended December 31, 2019, and 2018, respectively. Selling expenses were $96.3 million and $87.3 million for the years ended December 31, 2019 and 2018, respectively. The year-over-year increase in selling expenses of $9 million was primarily due to salary and other employee-related costs and external costs related to marketing and reimbursement support activities.

General and administrative expenses were $33.4 million and $34 million for the years ended December 31, 2019 and 2018, respectively, which represents a decrease of $0.6 million year-over-year. Interest expense was $17.1 million and $15.7 million for the years ended December 31, 2019 and 2018, respectively. We expect that while our operating expenses will continue to increase in the near term, primarily driven by commercial activities in support of ZILRETTA, line extension clinical trials for ZILRETTA, continued development of FX201 and FX301 and development activities associated with future additions to the pipeline. We believe we will be able to increasingly leverage our infrastructure in support of these efforts. As of December 31, 2019, we had approximately $136.7 million in cash, cash equivalents and marketable securities compared with $258.8 million as of December 31, 2018. In addition, earlier this quarter, we fully drew down $20 million from our revolving credit facility, which is secured by our accounts receivables. We believe that our current cash balance with the expected future sales [of ZILRETTA] (added by company after the call) and the ongoing prudent management of our expenses will enable us to reach profitability. However, our projections are based on certain market assumptions, which may or may not be affected by the coronavirus pandemic. As a result, we will continue to review and reassess our [assumptions] (added by company after the call)

in light of those factors. In addition, we will remain opportunistic as it relates to potential funding decisions, and we will do what we believe is in the best long-term interest of Flexion and our shareholders.

At this point, I would ask the operator to please open the line for questions.

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Questions and Answers

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Operator [1]

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(Operator Instructions)

Our first question comes from Randall Stanicky with RBC Capital Markets.

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Daniel James Busby, RBC Capital Markets, Research Division - Senior Associate [2]

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This is Dan Busby on for Randall. A couple of questions. First, among the high-prescribing accounts, in particular, can you give us a sense of how much more room there is to grow within those practices? I think I heard you mentioned that you haven't fully penetrated any of those accounts yet. And of the physicians in those accounts who aren't using it, what's the pushback you're hearing?

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David A. Arkowitz, Flexion Therapeutics, Inc. - CFO [3]

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Yes, Dan, this is David. So as we shared in our prepared remarks and in the deck, we've got almost 800 accounts that have purchased 50 units, more than 50 units of ZILRETTA launch to date. In the vast, vast majority of those accounts, ZILRETTA has not been fully adopted, incorporated into their practices and even there's a subset within those accounts of almost 50 accounts that have purchased more than 500 of units of ZILRETTA launch to date. So there's room to run with those almost 800 accounts as well as the other accounts that are less than 50 units of ZILRETTA purchased launch to date. And in terms of the other part of your question, in terms of why have they not fully incorporated ZILRETTA at this juncture. The way this will typically work is take a practice with 5 or 6 physicians [1 or] (added by company after the call) 2 of those physicians have started to use ZILRETTA and are using ZILRETTA for their patient -- appropriate patient population. But there just hasn't been awareness and experience with ZILRETTA for the other 3 or 4 docs in the practice. So it's a process. It's a process for the docs that are treating the existing patients to talk to their colleagues or our representatives to be making those physicians that are not yet using ZILRETTA, aware of ZILRETTA, getting them comfortable with reimbursement. So that's really what is going on.

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Daniel James Busby, RBC Capital Markets, Research Division - Senior Associate [4]

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Okay, that's helpful. And I guess, as a follow-up to that, if 1 practice, if 1 or 2 physicians within a practice, have secured reimbursement? Is it typically the case that other doctors who aren't using it, but may in the future, they would have reimbursement set up already? Or is that more kind of doctor by doctor?

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David A. Arkowitz, Flexion Therapeutics, Inc. - CFO [5]

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No, it's typically at the office level, at the clinic level. But the -- it's an issue of just getting familiar and comfortable with reimbursement, experiencing reimbursement, and that takes those docs that have not achieved that to just go through the process.

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Operator [6]

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Our next question comes from Elliot Wilbur with Raymond James.

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Elliot Henry Wilbur, Raymond James & Associates, Inc., Research Division - Senior Research Analyst [7]

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A couple of questions. First, Mike, I believe you mentioned in your commentary that you expect 1Q 2020 ZILRETTA sales to be essentially flat versus 4Q '19. Just want to get maybe a little bit more color behind that? How much of that you think is attributable to high deductible plans, perhaps influencing utilization versus other factors such as seasonality or just sort of overall company conservatism kind of in light of potentially increased macro uncertainty here in the short term?

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Michael D. Clayman, Flexion Therapeutics, Inc. - Co-Founder, President, CEO & Director [8]

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Yes. So I think there are a few things, Elliot. So it's a good and important question. First, just to recognize, historically, in this space, the hyaluronic acids are typically down 10% in the first quarter, with the driver being, as you point out, deductible. That is a key driver. I think that you also have to look at an older population may be less active in the winter months. And as a result, have less need to go to their physicians. So there are a couple of reasons why there is a basis for, relatively speaking, the first quarter being softer than other quarters and why we have guided to flat in the first quarter.

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Elliot Henry Wilbur, Raymond James & Associates, Inc., Research Division - Senior Research Analyst [9]

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Okay. And then with respect to your commentary around some of the data points that emerge from the claims data that you're referring to in terms of the payer mix with Medicare representing now a higher proportion. How should we think about the relative opportunity with respect to additional growth levers such as repeat administration, bilateral administration within the context of a greater Medicare book of business versus commercial?

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Michael D. Clayman, Flexion Therapeutics, Inc. - Co-Founder, President, CEO & Director [10]

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Yes, it's a good question. We -- as you know, the Medicare population has the opportunity to benefit most directly in a sense from ZILRETTA and that physicians can use same-day without any hesitancy and proceed with confidence that they will be reimbursed. They can repeat dose without any concern about reimbursement. They can do bilateral injections, et cetera. So we like the Medicare population. We also like the commercial population. It's very straightforward with Medicare. And I would say directionally, as a modest bump up in the representation of Medicare is, wind in our sails and will improve our circumstances. As we often say, this is not a light switch, but it's directionally encouraging.

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Elliot Henry Wilbur, Raymond James & Associates, Inc., Research Division - Senior Research Analyst [11]

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Okay. And then just a couple of financial questions for David as well. With respect to SG&A trends, they've held relatively flat in the $32 million, $33 million range over the last 4 quarters, not sure kind of directionally would expect it to increase, but obviously, you've been able to get a lot more leverage out of that line than probably what we would have expected at the beginning of the year. So how should we think about progression of that number over the course of 2020?

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David A. Arkowitz, Flexion Therapeutics, Inc. - CFO [12]

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Yes, Elliot, great question. So to your point, it has been relatively flat quarter-over-quarter in 2019 the G&A component of that. So if you just look at quarterly SG&A for fourth quarter about 20 -- excuse me, about $32 million, about $8 million of it is G&A, that will stay flat in the ensuing quarters. $24 million of it is commercial. And as we've talked about before, slightly more than half of that is related to headcount and support of spend, and we are right-size from a headcount standpoint. So increases in that portion will be minimal, where we're going to see some increases over time are external marketing activities in support of increasing ZILRETTA sales. But because that's only less than half of the selling and marketing spend, you're not going to see SG&A go up by meaningful amounts quarter-over-quarter. And on top of all that, as you might imagine, we're very focused on leveraging as best we can, our SG&A infrastructure that we've built up over the past 4 quarters.

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Edited Transcript of FLXN earnings conference call or presentation 12-Mar-20 8:30pm GMT - Yahoo Finance

Researchers and Doctors alike pursuing the field of stem cell research in treating heart attack survivors – Medical Herald

By Stem Cell Doctors

Key Takeaways:

The effects of myocardial infarction (heart attack) and congestive heart failure is a daunting task facing doctors and researchers alike. Heart attacks cause irreversible damage to the heart by weakening the heart muscle and making it less efficient in pumping blood through the circulatory system. It is noteworthy to remember that heart cannot take care of itself, meaning it has got minimum strength to regenerate whereby the untraceable muscle is replaced by a scar tissue. This leaves patients with a reduced cardiac role, which often leads to heart failure when the heart fails to accede to the demand placed upon it by the body in distributing blood. Current diagnosis treats the fallible symptoms such as low blood pressure but does not go to the seat of all problems. It is very well understood by this paradigm that heart is very reluctant and on second thoughts does not offer itself for being substituted for by the body.

Mayo Clinics are attributed with introduction of repairing heart attacks in individuals with aid of stem cells. Stem Cells restore cardiac muscle back to its original form meaning, the condition it was in before the heart attack, thus giving a roadmap to how the stem cells may function. Doctors at Mayo Research believe in the mouse model with the mouse prototype being an initial foray into advanced clinical trials in heart patients.

A study published in NPJ Regenerative Medicine digs out that human cardiopoietic cells present in the bone marrow mutate with defunct proteins to counter complex changes caused by a heart attack. The cardiopoietic cells are derived from stem cell sources of bone marrow.

The extent of transformation that a heart attack bears is too large for the heart attack to correct itself or to prevent any complexities from arising. However, cardiopoetic stem cell therapy induces change for the better partially or fully with minimum 85% of cellular functions promising to respond favourably to treatment. This was reiterated by Dr. Andre Terzic of Mayo clinics Center to Regenerative Medicine. He is senior author in this study.

Consecutive Heart Attacks leads to heart failure:

The heart muscles are sustained by an oxygen-rich blood flow to keep the heart pumping-contracting and expanding. However, during a heart attack, the arteries leading the blood flow are hindered by blockages in the artery. With no further outgo of blood, that area of the heart that is sourced by the artery begins to collapse involuntarily and a unhealthy scar tissue forms in the area. This could lead to a heart failure that eventually gives rise to heart failure.

A new insight into how stem cells repair the lifeless heart could pave the way to finding how stem cell therapy can help in the broader scheme of things.

The incisive insight in study of stem cells is lacking as to how it will rejuvenate other functional mechanisms, throwing light on the most intimate yet singularly comprehensive or regenerative mechanism in the body. Though customarily heart is considered to be a tough customer, it fails to pump blood as efficiently as it could from decapitated areas, and is the reason behind patients who have suffered a heart attack need to ingest a life-time of medicines to mitigate another heart attack and ensure its smooth functioning.

Heart Attack is the leading cause of death in the U.S as noted by Center for Disease Control and Prevention. The research additionally states that in a heart attack, the cardiac tissue dies involuntarily, thus weakening the heart.

The diseased heart responded to cardiopoeitic stem cell treatment with growth of blood vessels along with new heart tissue, so said Kent Arreli, Phd, Mayo Clinic Cardiovascular Researcher and first author of the study.

The Research: Leading the way

There is this research that delves upon the diseased hearts of mice that did not receive human cardiopoietic stem cell therapy with those that did. The result gave vent to the belief that more than 4000 cardiac proteins were present, 10 % of which suffered damages by a heart attack.

While we were always expecting a normal heart function after this study, the present outcome quite bewildered us where the diseased hearts shifted to and fro and came to rest on a healthy pre-diseased heart.

Cardiopoietic Stem Cells are being put to test in advanced clinical trials in heart patients.

It has been corroborated that current findings in stem cell therapy will bring some additional guidance and will steer therapeutic exercise in the near future.

Though it has to this point been proven, the fruitful remedies of stem cell therapies for heart failure, there are several unproven stem cell remedy experiments that are not still not ready to exercise in the real world.

A heart attack has been understood to happen when blood supply is cut-off to that portion of the heart muscle that causes irreparable damage and with time and many repeat attacks, a scar is formed resulting in a heart failure!

It is for over 2 decades that scientists have studied the positive benefits of stem cells which might repair a frail and damaged heart and restore it and these cell types can be made from other cells also coming as it does under the umbrella tern cardiac regeneration.

Cardiac Regeneration:

Cardiomyocites are highlighted here that are the beating muscle cells located in the chamber of the heart, Although scientists can grow cardiomycites in the lab from embryonic stem cells, growing them from the heart itself is showcasing itself plausibly.

Stem cells are inserted in the heart using a catheter. These stem cells are taken from the bone marrow and now that they are in place, they rejuvenate damaged heart tissues. There are pros and cons with this technique of insertion of stem cells into the heart. Having said that, it comes as no surprise when a donor who may be a stranger donates a stem cell which could be unacceptable to the body. But a positive point is that donor problems do not pose a big problem that helps the doctors to forge ahead relentlessly.

Long term effects are a bother still and more trials have to be conducted to probe the longevity question.

Though it comes as no surprise now with stem cells being delivered to the heart is possible and error-free, but the evidence is not noteworthy. There are 61 centers in all in the United States that accomplish the stem cell therapy to bring to life people with heart failure. These centers charge an estimated USD 7694 for a single treatment of autologous stem cells. ( from ones own body) which portrays a lot of scope with some 17 patients who were infused with stem cells taken from their own hearts to succeed in an unequivocal way.

Wrapping Up:

Two methods have come to light so far in passing stem cells into the body with one coming from external donors and the other being fed by ones own body. It has to be revealed still as to which method comes as more cogent in its delivery. When can one say with authority that stem cell therapy has come to stay? It is a few years down the line, some say with a view that it is work in progress and others are of the opinion that there is much work to be done.

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Researchers and Doctors alike pursuing the field of stem cell research in treating heart attack survivors - Medical Herald

Weston man builds epic motorcycle to promote saving lives through Be The Match donations – Wausau Daily Herald

By Stem Cell Doctors

Todd Euen of Johnstown, Pennsylvania, and Mark Ecklund of Weston stand behind the Be the Match motorcycle that Ecklund designed and built. Ecklund donated life-saving stem cells to Euen.(Photo: Photo courtesy of Mark Ecklund)

WESTON - It's a gleaming, curvy, sport-style motorcycle with a distinctArt Deco look, and there's no other bike like it on Earth.

Mark Ecklund of Weston took two years of painstaking, detail-oriented work to build it, hand-fabricating most of its body work from thin aluminum. For just the tail section, the 53-year-old machinist took two weeks to patiently and gently tap using a hand-held, hammer-like metal molding toolapiece of aluminum into the shape he wanted.

The project represents the ability to save lives. Mark created the motorcycle to honor and promote Be The Match, a worldwideorganization that works to matchdonors of life-saving bone marrow and stem cells to people suffering from blood cancers such a leukemia and lymphoma. In 2012, Mark donated stem cells that were used to save the life of a 53-year-old Pennsylvania man, who is a husband, father and grandfather.

Mark is a serial inventor who has built and designed things such as a one-person hovercraft, a safety faucet that prevents scaldingand an improved version of a compound bow, and it's his habit to enthusiastically andcompulsively throw himself into projects. But even for his standards, this motorcycle, once a brand-new Indian cruiser, is special.

A year after the transplant, Ecklund and the stem cell recipient, Todd Euen of Johnstown, Pennsylvania, met and became instant friends. The experience was so gratifying that Ecklund can't even begin to explain it. All he can say is that the motorcycle is a physical manifestation of those feelings, and a vehicle to promote Be The Match. He and his wife, Chris Ecklund,are doing anything they can to encourage people to register for Be The Match donations.

"We want to bring that awareness to people, to have more people register," Chrissaid.

The motorcycle is a work of art, Mark said, "that is more of a campaign."

Todd Euen and his family have grown close to Mark Ecklund and his wife, Chris. They posed for this portrait: Front row, left to right: Kaiden Miller (Todd's grandson), Khloe Miller (granddaughter), Rachael Euen (daughter) and Kylie Miller (granddaughter). Middle row, left to right: Amy Euen (Todd's wife); Emily Euen (daughter); Chris Ecklund. Back row: Erik Euen (son); Todd Euen; Mark Ecklund.(Photo: Courtesy of Todd Euen)

Todd, a controller at a Ford dealership, was diagnosed with leukemia in July 2012. In order to save his life, doctors rushed him to Pittsburgh, located about 66 miles west of Johnstown. If Todd hadn't gotten treatment, he likely would have died within two weeks, doctors told him.

"I was in shock," Todd said.

He received Mark's donation in a procedure done on Christmas Eve of 2012.

Be The Match requires that donors and recipients wait a yearafter procedures before connecting with each other. After that year passed, Todd contacted Mark to get to know him and thank him.

"I didn't know what to expect when I met him. He basically saved my life," Todd said. "It was real emotional when we met. ... Our family is forever grateful to him."

Mark Ecklund's motorcycle is etched with information about the Be The Match donor program.(Photo: Courtesy of Mark Ecklund)

Chris and Mark decided to become donors when Mark turned 35. They both regularly give blood, and it was Mark's idea to do more.

"We just wanted to help people," Mark said.

They found Be The Match, did a little research, and then, almost on a whim, drove to the Appleton office of Be The Match to register. Chris still hasn't been matched with a recipient.

"I'm really jealous of Mark," she said.

After meeting Todd , Mark came up with the idea to design and build the Be The Match motorcycle. He talked about his plans with Chris, and she agreed that they should purchase the 2015 Indian Scout to convert. Chrisdidn't quite grasp what her husband had in mind; she thought it would be a light modification of the new Indian model.

As Mark started to the project, "I thought, 'We spent all this money to tear it apart,'" Chris said.

Markvisualized his motorcycle from the start. "I knew exactly what I wanted. I knew exactly what I was going to do," he said.

He wanted something that would be magnetic to other motorcycle enthusiasts.And even though Chris didn't know the details, she's been married to Mark for 29 years. So she wasn't surprised when he spend nearly all his free time working on the bike. Nor was she surprised at the result.

They take the motorcycle to races and shows. First riders come see the bike, then Chris and Mark go into their Be The Match spiel, and often Chris will get people to register for donations on the spot. (It requires filling out a form and doing some cheek swabs to get DNA samples.)

Jess Klingberg, the Be The Match community engagement specialist based in Appleton, said the motorcycle is magnet for potential donors, helping sign up potential donors by the dozen. She attended a motorcycle rally with the Ecklunds. "That motorcycle turns a lot of heads," she said.

Todd accompanied Mark and Chris to one show near Pittsburgh, and even though he's gotten to know Mark and his all-in attitude, he was still surprised at how much gusto both Mark and Chris display when promoting Be The Match.

"They have jumped all in," Toddsaid with a laugh.

A live, over-the-air Radiothon for Be the Match will be held from 7 a.m. to 7 p.m. March 19 on the Wausau rock radio stationWIFC-FM 95.5Jess Klingberg, the Be The Match community engagement specialist who works in the organization's Appleton office, will be on air to explain details about the program and tell stories about what Be The Match can mean for individuals dealing with cancer.

Contact Keith Uhlig at 715-845-0651 or kuhlig@gannett.com. Follow him at @UhligK on Twitter and Instagram or on Facebook.

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Weston man builds epic motorcycle to promote saving lives through Be The Match donations - Wausau Daily Herald

Future Growth Of Animal Stem Cell Therapy Market By New Business Developments – News by aeresearch

By Stem Cell Clinics

Tea Sachets Industry Size 2019, Market Opportunities, Share Analysis up to 2025 By Market Study Report

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Future Growth Of Animal Stem Cell Therapy Market By New Business Developments - News by aeresearch

Can hybrid embryos save the white rhinos from extinction? – Science 101

By Embryonic Stem Cells

The northern white rhino population is in jeopardy

The northern white rhino is one of the animal kingdoms many majestic giants, but years of poaching has taken a toll on their population. From 1970 to 1980, their numbers plummeted from 500 to 15 as illegal hunters pursued white rhinos for the ivory of their horns.

Things started to turn around during the 1990s and 2000s, groups and individuals began to crack down on poachers within the white rhinos range. As a result, the population of white rhinos in the wild recovered slightly, peaking at around 32 individuals.

Since 2003, the rate of white rhino poaching has been on the rise and has affected the animals numbers. As of 2008, northern white rhinos have been declared extinct in the wild, and in 2018, the last male northern white rhino died. Now, there are only two of these magnificent beasts left on Earth. Both of them are females.

Najin and Fatu are the last two northern white rhinos in existence. They live at the Ol Pejeta Conservancy in Kenya, and they could be the species last hope for the future. In 2014, keepers in the Czech Republic collected sperm samples from a male northern white rhino living in their care.

Those samples were frozen and stored, and later, they were used in an attempt to breed Najin and Fatu. Both attempts at inducing pregnancies in the two female rhinos were unsuccessful, forcing scientists to consider new methods of approach for saving the white rhinos from extinction.

Typically, when a species is placed on the endangered list, a recovery plan is established by whatever local conservancy group oversees the population. From there, breeding programs of captive individuals are used to begin bolstering the number of individuals on the planet.

When healthy breeding populations have been established, in most cases, reintroduction begins. Small populations of the species are released into the wild to begin repopulation. However, in the case of the northern white rhinos, scientists and conservationists alike have been stuck at step two for decades.

Unwillingness and inability to breed arent uncommon among captive species and individuals, and in most cases, zoos can jockey animals around until a pair matches and produces offspring. In the case of Najin and Fatu, the options for procreation are far more limited. Even the fallback of artificial insemination isnt working for them, so what are scientists to do?

Weve revived entire species from the dead before, but it has never been an easy task. Fortunately, the world of reproductive sciences has been evolving quickly, and conservationists and animal experts now have myriad options to choose from when it comes to creating new life.

Neither surviving female is healthy enough to birth live young. Aside from that, there is the added challenge of finding an option that preserves the northern white rhino genome while maintaining high enough levels of viability.

One possible route to repopulation involves approaching conventional methods from a new and enlightened angle. Although neither Najin nor Fatu can bear young, they both still produce viable egg cells, which can be harvested, frozen, and kept in a lab.

Much like humans undergoing fertility therapy or other conception aids, the grandmother-granddaughter pair or northern white rhinos can hope for success through in-vitro fertilization. This method of conception combines sperm and multiple egg cells in an external environment before implanting them in a host mother.

By using multiple eggs during the in-vitro process, the chances for success, even in females with fertility issues, is significantly increased. In some fortunate cases, the method is so effective, and it results in multiple pregnancies. Once the sperm has fertilized the eggs, the cells are transferred to a living host.

While Najin and Fatu may not be the physical mothers of any of their calves, modern reproductive science has made it possible for their genes to be passed on to another generation.

How? with modern science, a surrogate mother from the thriving population of southern white rhinos could become the mother to their children.The two types of animals have similar enough reproductive organs and their eggs could be used in place of Najin or Fatus.

While the animals are compatible, gathering eggs from them is a far more complicated procedure.

Researchers working on bringing back the northern white rhinos have managed to gather a few eggs so far, but not nearly enough to repopulate an entire species.

Its no secret that rhinoceroses are large animals. Just as cattle and horses have significantly larger hearts than we humans do, rhinos have much larger reproductive organs. Locating and withdrawing eggs from a rhinos ovaries is a far greater ordeal than it is for humans.

To complicate matters further, the ovaries of a southern white rhino are located three to four feet from her rump, and the veterinarian seeking to collect the eggs must guide a probe that distance up her rectum and into an ovary before using a catheter to remove the eggs.

The procedure is anything but easy. In addition to the difficulty involved in the process of extracting eggs, the success rate of current methods is hardly ideal. Researchers working on bringing back the northern white rhinos have managed to gather a few eggs so far, but not nearly enough to repopulate an entire species.

The odds of reestablishing a sustainable population of northern white rhinos through in-vitro fertilization and surrogacy currently seem pretty slim. Fortunately for the rhinos, science has a few other methods up its sleeve.

In the last decade, stem cell research has gone from a thing of whimsy to an advanced field of study that continues to improve by leaps and bounds with every passing year. Its applications are seemingly endless, and they just might be the answer that the northern white rhino conservationists have been looking for.

Stem cells are sort of like biological canvases. They come in different varieties: Totipotent, pluripotent, multipotent, oligopotent, and unipotent. Each of these types has unique limitations and can be found in various sources from embryonic tissue to adult bone marrow.

To make baby rhinos, scientists have been focused on induced pluripotent stem cells, which are gathered and grown from the skin of adult white rhinos

A cell from your bicep and a cell from your gametes (sperm or egg) both hold the same blueprints; they just come in different packaging.

Pluripotent cells behave similarly to embryonic stem cells, which can be coaxed into becoming just about any other type of cell. In this case, even though the original cells were taken from the skin of adult rhinos, they can be trained to become something different, such as egg cells.

Using what knowledge we currently have of stem cells and their manipulation, scientists can tell a northern white rhinos skin cell to become a viable egg or sperm cell. From there, they can attempt in-vitro fertilization and implantation into a surrogate, even without fertile parents.

The method is still in its infancy, but it has been successfully carried out more than once.

With stem cells as a backup and surrogates abound, Najin and Fatu have plenty of options. In late 2019, conservationists and rhinos alike received promising news. Eggs gathered from the two northern white rhinos had been fertilized and resulted in successful embryos. Those embryos were frozen in liquid nitrogen and prepared for a long journey.

Waiting down in southern Africa are the lucky mamas who will become the surrogates for the next generation of northern white rhinos. The embryos have quite a ways to travel before they can be implanted. After that, they can grow within their new mother for the 16 to 18-month gestation period typical of white rhinos.

Although the methods of creating viable embryos are currently long, challenging, and not terribly efficient, these babies-to-be are incredibly promising first steps. In addition to the two successful in-vitro attempts in September, December of 2019 saw the creation of a third viable embryo.

2020 will undoubtedly see further attempts at creating more embryos. With luck, we can soon hope to hear news of successful implantations in surrogate moms. In 2021, we can throw a worldwide baby shower for some bouncing baby northern white rhinos, whose births will serve as a beacon of hope for a dying species.

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Can hybrid embryos save the white rhinos from extinction? - Science 101

Autologous Stem Cell Based Therapies Market 2020: Potential Growth, Challenges, Attractive Valuation | Key Players: Anterogen, Holostem Advanced…

By Embryonic Stem Cells

Global Autologous Stem Cell Based Therapies Market Report is a professional and in-depth research report on the worlds major regional market conditions of the Autologous Stem Cell Based Therapies industry, focusing on the main regions and the main countries (United States, Europe, Japan and China).

Market Segmentations: Global Autologous Stem Cell Based Therapies market competition by top manufacturers, with production, price, revenue (value) and market share for each manufacturer.

Based on type, report split into Embryonic Stem Cell, Resident Cardiac Stem Cells, Umbilical Cord Blood Stem Cells.

Based on the end users/applications, this report focuses on the status and outlook for major applications/end users, consumption (sales), market share and growth rate for each application, including Neurodegenerative Disorders, Autoimmune Diseases, Cardiovascular Diseases.

The report introduces Autologous Stem Cell Based Therapies basic information including definition, classification, application, industry chain structure, industry overview, policy analysis, and news analysis. Insightful predictions for the Autologous Stem Cell Based Therapies Market for the coming few years have also been included in the report.

Autologous Stem Cell Based Therapies Market landscape and market scenario includes:

The Autologous Stem Cell Based Therapies industry development trends and marketing channels are analyzed. Finally, the feasibility of new investment projects is assessed, and overall research conclusions offered.

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Stem cell therapy revives cardiac muscle damaged during heart attacks – Cardiovascular Business

By Stem Cell Treatment

For their study, Terzic and colleagues analyzed the hearts of mice that received cardiopoietic stem cell therapy as well as those that did not. They used an algorithmic approach to map the proteins in the heart muscle, identifying 4,000 proteins. Ten percent of these were damaged during a heart attack.

The investigators found that the therapy either fully or partially reversed two-thirds of the changes caused by the event. And about 85% of cellular functional categories impacted by infarction responded positively to treatment, the authors wrote. They also noted that new blood vessels and heart tissue began to grow as a result of the intervention.

In the United States, someone has a heart attack every 40 seconds, according to the study, which kills this precious cardiac tissue and leads to a significantly weaker heart. Although cardiopoietic stem cells are still being investigated in advanced clinical trials in human patients, this most recent study is a big step in the right direction.

The current findings will enrich the base of knowledge pertinent to stem cell therapies and may have the potential to guide therapeutic regimens in the future," Terzic concluded.

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Stem cell therapy revives cardiac muscle damaged during heart attacks - Cardiovascular Business

To Turbocharge Anti-Aging Treatment, Just Add… a Protein Found in Fruit Flies? – Singularity Hub

By Stem Cell Treatment

The hunt for the elixir of life is such a universal mythological trope that to talk about it in the context of science seems almost ridiculous. But breakthroughs in the last decade have made the impossible seem possible, and researchers are quickly converging on the consensus that aging may well be a disease that we can treat just as easily as any other.

Impressive results in animals that have had their lifespans boosted by up to 40 percenthave started making their way into humans. Some trials are more questionable than others, but most promisingly there seem to be multiple potential avenues, from cocktails of common drugs to gene therapies and stem cell treatments.

Stem cells are particularly promising, because they can be coaxed into becoming any kind of cell before being transplanted to treat damaged tissue. These therapies often fail to work well in older tissue, though, limiting their future use in older patients who could need them most. This appears to be because these tissues have significantly higher levels of inflammation that prevent stem cells from properly integrating.

Now Portuguese researcher Joana Neves has won the 2019 Sartorius & Science Prize for Regenerating Medicine & Cell Therapy for her discovery of a way to sidestep this roadblock and significantly increase the success of stem cell treatments.

Because of the central importance of tissue repair to all organisms, Neves assumed that many of the mechanisms behind it would be shared among all animals. So she started looking at proteins produced by immune cells in the well-known animal model of the fruit fly.

She discovered that a poorly-understood protein known as MANF (mesencephalic astrocyte-derived neurotrophic factor) plays a crucial role in reducing inflammation in fruit flies. More importantly, she found that mice and humans also produce it, and its prevalence reduces in all the species as they age, suggesting it plays a key role in limiting age-related inflammation.

That prompted her to see if introducing MANF would boost the effectiveness of stem cell treatments in older animals. She used the protein in combination with a procedure that uses stem cells to replace degenerating photoreceptors in the retina of older mice and found it greatly improved the restoration of vision.

Going further, her research team then investigated whether MANFs anti-inflammatory effects could have more general age-defying benefits. Previous research had already demonstrated that infusing old mice with blood from younger ones could reduce various signs of aging, and by carrying out similar experiments the team showed that MANF is one of the factors responsible for that outcome. They even showed that directly injecting mice with MANF could have similar effects.

Translating these ideas to treat other diseases and for use in humans will take some time, but the research chimes with work on an emerging class of drugs known as senolytics. These are drugs that kill senescent cells, which are zombie cells that become more prevalent as we age and spew out harmful chemicals that result in chronic inflammation.

Senolytics are generally seen as a broad-spectrum treatment that could help stave off multiple conditions at once, but they could also be used to create a more hospitable environment for stem cell treatments just like MANF.

There are still plenty of barriers to bringing any of these treatments to the clinic, from the difficulty of producing stem cells to the challenges of regulating treatments for aging (a condition we still dont formally class as a disease), or fighting back against the huge number of bogus treatments that threaten to undermine trust in the field. But given the huge potential for near-term impact, theres growing momentum.

Weve moved from being able to extend health and lifespan of simple organisms like yeast and worms and flies to being able to do this quite easily in animals, in mice and monkeys, David Sinclair, director of the Center for the Biology of Aging at Harvard Medical School, told the Harvard Gazette.

He added that instead of trying to treat one disease at a time, he believes we can develop medicines that will treat aging at its source, therefore having a much greater impact on health and lifespan than drugs that target single diseases.

The wheels are in motion for us to find out.

Image Credit: Monika Robak from Pixabay

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To Turbocharge Anti-Aging Treatment, Just Add... a Protein Found in Fruit Flies? - Singularity Hub

Lattice Biologics Ltd. Announces Initial Recruitment of Patients for a Phase 1 Clinical Trial to Access Safety and Efficacy of AmnioBoost for…

By Stem Cell Treatment

BELGRADE, Mont. Lattice Biologics Ltd. (TSX-V: LBL) (OTCBB: LBLTF) (Lattice Biologics or the Company) announces it has begun enrolling patients in its Phase 1 clinical trial to address safety and efficacy of its novel stem cell technology, AmnioBoost, for the treatment of severe acute respiratory syndrome (SARS) related to COVID-19 infection.

AmnioBoost is derived from amniotic fluid taken from non-related, healthy, living donors during a Caesarian delivery. The baby is not harmed in any way.

To be eligible for the U.S. trial, individuals must have laboratory confirmed infection with COVID-19 and evidence of lung involvement requiring supplemental oxygen or mechanical ventilation. The study will not enroll individuals with mild symptoms or individuals who are asymptomatic.

All potential patients will undergo a physical exam, participants will then be randomized into the investigational group or the placebo group. Individuals enrolled into the investigational group will receive ~ 5 million stem cells of AmnioBoost on the first day of enrollment and will receive another ~ 5 million stem cells on the second day of enrollment.

Clinicians will monitor the patients temperature, blood pressure, need for supplemental oxygen, and other factors daily to determine daily scores based on a scale of clinical outcomes.

In the initial stage of investigation, the clinicians will compare participant outcomes on day seven in both groups to assess if AmnioBoost treatment has produced any clinical benefit.

The study will be halted if there is no evidence of a treatment difference between AmnioBoost and placebo.

Initial patient enrollment in the trial will be limited to 10 patients and conducted in the Seattle area, as it is one of the most concentrated areas of COVID -19 infection in the United States.

We thank the patients in advance for their participation in this cost free to the patient trial. We look forward to using a novel technology in the treatment of this highly infectious disease and to make sure the trial is carried out in the most effective manner possible, said Guy Cook, CEO of Lattice Biologics Ltd.

In addition, the Company announces that it was named in a statement of claim filed January 2019 by Cheryl Farmer, the former Chief Financial Officer of the Company, for wrongful dismissal in the amount of $2.5 million USD. The Company and the plaintiff have come to a satisfactory resolution and Lattice Biologics trusts that Ms. Farmer will have success in her future endeavors.

The Company reserved $600,000 Canadian in its most recent audited financial statements. The settlement includes a severance payment of $100,000 to be paid over 9 months, and 18 million shares at $.05 Canadian. The shares are subject to TSX approval, and all regulatory restrictions.

Further, the Company has arranged a non-brokered private placement of up to 10 million units (Units) at a price of $0.10 per Unit for aggregate gross proceeds of $1,000,000 (the Offering). Each Unit will be comprised of one common share (Share) and onehalf transferable Share purchase warrant of the Company (Warrant). Each full Warrant will entitle the Subscriber to purchase one Warrant Share for a 24 month period after the Closing Date at an exercise price of $0.10 per share. Proceeds raised from the Offering will be used for the expansion of its stem cell technology to address CONVID-19. Finders fees may be payable on the private placement, subject to the policies of the TSX Venture Exchange.

This offering is subject to TSX Venture Exchange acceptance and expected to close March 30, 2020.

The Company also announces that its Board of Directors has today approved the grant of 3 million stock options to directors, and 6 million shares to employees and consultants, which are exercisable into common shares of LBL.V at a price of $0.075 per common share in accordance with TSX Policy 4.4, subject to the rules of the TSX Venture Exchange and the Corporations Stock Option Plan. The options have a term of five years and will expire on March 16, 2025.

About Lattice Biologics Ltd.:

Lattice Biologics is traded on the TSX-V under the symbol: LBL. The Company is an emerging personalized/precision medicine leader in the field of cellular therapies and tissue engineering, with a focus on bone, skin, and cartilage regeneration.

Lattice Biologics develops and manufactures biologic products to domestic and international markets. The Companys products are used in a variety of surgical applications.

Lattice Biologics maintains its headquarters, laboratory and manufacturing facilities in Belgrade, Montana as well as offices in Phoenix, Arizona. The facility includes ISO Class 1000 and ISO Class 100 clean rooms, and specialized equipment capable of crafting traditional allografts and precision specialty allografts for various clinical applications. The Lattice Biologics team includes highly trained tissue bank specialists, surgical technicians, certified sterile processing and distribution technicians, and CNC operators who maintain the highest standards of aseptic technique throughout each step of the manufacturing process. From donor acceptance to the final packaging and distribution of finished allografts, Lattice is committed to maintaining the highest standards of allograft quality, innovation, and customer satisfaction.

Lattice Biologics maintains all necessary licensures to process and sell its tissue engineered products within the U.S. and internationally. This includes Certificates to Foreign Governments from the U.S. Food and Drug Administration (FDA) and registrations for 29 countries, which allow the export of bone, tendon, meniscus, ligament, soft tissue, and cartilage products outside of the U.S.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Cautionary Statement on Forward-Looking Information:

Certain information contained in this news release constitutes forward-looking statements within the meaning of the safe harbour provisions of Canadian securities laws. All statements herein, other than statements of historical fact, are to be considered forward looking. Generally, forward-looking information can be identified by the use of forward-looking terminology such as planned, potential, future, expected, could, possible, goal, intends, will or similar expressions. Forward-looking statements in this news release include, without limitation: information pertaining to the Companys strategy, plans, or future financial performance, such as statements with respect to the Transaction, and other statements that express managements expectations or estimates of future performance. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of Lattice to be materially different from those expressed or implied by such forward-looking statements.

Forward-looking statements are necessarily based upon a number of factors and assumptions that, while considered reasonable by management as of the date such statements are made, are inherently subject to significant business, economic and competitive uncertainties and contingencies. The factors and assumptions that could prove to be incorrect, include, but are not limited to: that market prices will be consistent with expectations, the continued availability of capital and financing, and that general economic, market and business conditions will be consistent with expectations. The forward-looking statements are not guarantees of future performance. We disclaim any obligation to update or revise any forward-looking statements, except as required by law. Readers are cautioned not to put undue reliance on these forward-looking statements.

United States Advisory: The securities referred to herein have not been and will not be registered under the United States Securities Act of 1933, as amended (the U.S. Securities Act), and may not be offered, sold, or resold in the United States or to, or for the account of or benefit of, a U.S. Person (as such term is defined in Regulation S under the U.S. Securities Act) unless an exemption from the registration requirements of the U.S. Securities Act is available. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in the state in the United States in which such offer, solicitation or sale would be unlawful.

Follow us on Twitter: @LatticeBio

View source version on businesswire.com: https://www.businesswire.com/news/home/20200317005218/en/

Contacts

Guy Cook, CEO Lattice Biologics Ltd. 480-563-0800 Office News@LatticeBiologics.com http://www.LatticeBiologics.com

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Lattice Biologics Ltd. Announces Initial Recruitment of Patients for a Phase 1 Clinical Trial to Access Safety and Efficacy of AmnioBoost for...

Fortress Biotech Reports Record Fourth Quarter and Full-Year 2019 Financial Results and Recent Corporate Highlights – BioSpace

By Stem Cell Treatment

Revenue from marketed dermatology products increased 85% for fourth quarter 2019 and 49% for full-year 2019 compared to 2018

NDA for IV tramadol accepted for review by FDA; PDUFA date is set for October 10, 2020

Rolling NDA submission for CUTX-101 for the treatment of Menkes disease is on track to begin in the fourth quarter of 2020

NEW YORK, March 16, 2020 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (NASDAQ: FBIO) (Fortress), an innovative biopharmaceutical company, today announced financial results and recent corporate highlights for the fourth quarter and full year ended December 31, 2019.

Fortress achieved multiple key milestones in 2019 and early 2020, including:

Lindsay A. Rosenwald, M.D., Fortress Chairman, President and Chief Executive Officer, said, We have generated significant momentum throughout 2019 and into early 2020. In order to drive our next phase of growth, our world-class business development team continues to identify and acquire high-potential marketed and development-stage assets to further expand our portfolio of product opportunities. Additionally, Fortress and our development partners continue to advance our clinical-stage programs across multiple therapeutic categories. With five commercial products and over 25 programs in development, we aim to continue to meaningfully increase value and decrease overall risk for Fortress shareholders. Looking ahead, we expect 2020 to be a record revenue-generating year and a transformational one for many of the development-stage programs across Fortress and our partner companies. Finally, we look forward to continued acquisitions of marketable dermatology drugs and in-licenses of development-stage drug candidates.

2019 and Recent Corporate Highlights1:Marketed Dermatology Products

IV Tramadol

CUTX-101

CAEL-101

MB-107 (Lentiviral Gene Therapy for XSCID)

Cosibelimab (formerly CK-301, an anti-PD-L1 antibody)

CK-101 (third-generation EGFR inhibitor)

MB-102 (CD123-targeted CAR T cell therapy)

MB-101 (IL13R2-targeted CAR T cell therapy)

MB-108 (Oncolytic Virus C134)

MB-104 (CS1-targeted CAR T cell therapy)

MB-103 (HER2-targeted CAR T cell therapy)

MB-105 (Prostate Stem Cell Antigen (PSCA)-targeted CAR T cell therapy)

MB-106 (CD20-targeted CAR T cell therapy)

BAER-101 (novel 2/3subtype-selective GABA A positive allosteric modulator [PAM])

General Corporate

Financial Results:

About Fortress Biotech Fortress Biotech, Inc. (Fortress) is an innovative biopharmaceutical company that was recently ranked number 10 in Deloittes 2019 Technology Fast 500, an annual ranking of the fastest-growing North American companies in the technology, media, telecommunications, life sciences and energy tech sectors, based on percentage of fiscal year revenue growth over a three-year period. Fortress is focused on acquiring, developing and commercializing high-potential marketed and development-stage drugs and drug candidates. The company has five marketed prescription pharmaceutical products and over 25 programs in development at Fortress, at its majority-owned and majority-controlled partners and at partners it founded and in which it holds significant minority ownership positions. Such product candidates span six large-market therapeutic areas, including oncology, rare diseases and gene therapy, which allow it to create value while mitigating risk for shareholders. Fortress advances its diversified pipeline through a streamlined operating structure that fosters efficient drug development. The Fortress model is driven by a world-class business development team that is focused on leveraging its significant biopharmaceutical industry expertise to further expand the companys portfolio of product opportunities. Fortress has established partnerships with some of the worlds leading academic research institutions and biopharmaceutical companies to maximize each opportunity to its full potential, including Alexion Pharmaceuticals, Inc., City of Hope, Fred Hutchinson Cancer Research Center, InvaGen Pharmaceuticals Inc. (a subsidiary of Cipla Limited), St. Jude Childrens Research Hospital and Nationwide Childrens Hospital. For more information, visit http://www.fortressbiotech.com.

Forward-Looking StatementsThis press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended. As used below and throughout this press release, the words we, us and our may refer to Fortress individually or together with one or more partner companies, as dictated by context. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on managements current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to our growth strategy; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; uncertainties relating to preclinical and clinical testing; risks relating to the timing of starting and completing clinical trials; our dependence on third-party suppliers; risks relating to the COVID-19 outbreak and its potential impact on our employees and consultants ability to complete work in a timely manner and on our ability to obtain additional financing on favorable terms or at all; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law. The information contained herein is intended to be reviewed in its totality, and any stipulations, conditions or provisos that apply to a given piece of information in one part of this press release should be read as applying mutatis mutandis to every other instance of such information appearing herein.

Company Contacts:Jaclyn Jaffe and William BegienFortress Biotech, Inc.(781) 652-4500ir@fortressbiotech.com

Investor Relations Contact:Daniel FerryLifeSci Advisors, LLC(617) 430-7576daniel@lifesciadvisors.com

Media Relations Contact:Tony Plohoros6 Degrees(908) 591-2839tplohoros@6degreespr.com

____________________________________________1 Includes product candidates in development at Fortress, majority-owned and controlled partners and partners in which Fortress holds significant minority ownership positions. As used herein, the words we, us and our may refer to Fortress individually or together with our affiliates and partners, as dictated by context.

FORTRESS BIOTECH, INC. AND SUBSIDIARIESConsolidated Balance Sheets($ in thousands except for share and per share amounts)

FORTRESS BIOTECH, INC. AND SUBSIDIARIESConsolidated Statements of Operations($ in thousands except for share and per share amounts)

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Fortress Biotech Reports Record Fourth Quarter and Full-Year 2019 Financial Results and Recent Corporate Highlights - BioSpace

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