Q2 2019 Earnings Call

Good afternoon, and welcome ladies and gentlemen to be Cytokinetics second quarter 2019 conference call. At this time I would like to inform you that this call is being recorded and that all participants are in a listen only mode. At the request of the company. We will open the call for questions and answers. After the presentation I will now turn the call over to Dianne Wiser Cytokinetics, Vice President of corporate Communications and Investor Relations.

Operator: At the request of the company, we will open the call for questions and answers after the presentation. I will now turn the call over to Diane Weiser, Cytokinetics' Vice President of Corporate Communications and Investor Relations. Please go ahead.

Diane Weiser: Good afternoon, everyone, and thank you for joining us today. Robert Blum, our President and Chief Executive Officer, will kick off the call with introductory comments about the current state of our business. Then, Fady Malik, our EVP of Research and Development, will provide updates on our cardiovascular programs, including the phase 3 development of Omacam-3-Micarbol, our cardiac myosin activator, and the phase 1 development of AMG-594, our cardiac troponin activator, both in our collaboration with Amgen, as well as the development of CK274, our wholly owned cardiac myosin inhibitor, now proceeding Andy Wolfe, our SVP and Chief Medical Officer, will then share updates on our neuromuscular program focused on Rel-Deceptive, our fast skeletal muscle troponin activator, in collaboration with Estella.

Please go ahead.

Good afternoon, everyone and thank you for joining us today, Robert Blum, our President and Chief Executive Officer will kick off the call, but introductory comments about the current state of our business. Then study now with our SVP of research and development will provide updates on our cardiovascular program. We put in the phase three development of Omecamtiv Mecarbil, a cardiac myosin activator and the phase one development of the Mt. Fivenine for a cardiac proponent activator, both under our collaboration with Amgen as well as the development of CK two studies for our wholly owned cardiac myosin inhibitor.

Now proceeding from phase one to phase two development.

Andy Wolff, our SVP and Chief Medical Officer will then share updates on our neuro muscular program focused on all the sometimes are fast skeletal muscle troponin activator under our collaborate collaboration with Astellas.

Robert I. Blum: Robert Wong, our VP and Chief Accounting Officer, will provide a financial overview for the quarter, and Ching Jaw, our SVP and Chief Financial Officer, will discuss corporate development strategies before Robert concludes with additional thoughts on the company's outlook and expected miles. Please note that portions of the following discussion, including our responses to questions, contain statements that relate to future events and performance rather than historical facts and constitute forward-looking statements. Our actual results might differ materially from those projected in these forward-looking statements. Additional information concerning factors that could cause our actual results to differ materially from those projected in these forward-looking statements is contained in our SEC filings. We undertake no obligation to update any forward-looking statements after this call. Now, I will turn the call over to Robert.

Robert one.

Our VP and Chief Accounting Officer will provide a financial overview for the quarter and chicken job, our SVP and Chief Financial Officer will discuss corporate development strategies before Robert concludes with additional thoughts on the Companys outlook and expected milestones.

Please note the portions of the following discussion, including our responses to questions contains statements that relate to future events and performance rather than historical facts and constitute forward looking statements actual results may differ materially from those projected in these forward looking statements.

Additional information concerning factors that could cause our actual results to differ materially from those in these forward looking statements is contained in our FCC filings. We undertake no obligation to update any forward looking statements. After this call and now I will turn the call over to Robert Thank you Diane and thanks again to everyone for joining us on the call today.

Robert I. Blum: Thank you, Diane, and thanks again to everyone for joining us on the call today. During the second quarter, we made good progress across our pipeline, with particular emphasis on our investigational medicines directed to diseases associated with cardiac muscle dysfunction, including heart failure with reduced ejection fraction and hypertrophic cardiomyopathy, or HCM. In addition, we continue to gather data to inform potential progression of our neuromuscular program. As has been our history, we continue to follow the science.

During the second quarter, we made good progress across our pipeline with particular emphasis on our investigational medicine was directed to diseases associated with cardiac muscle dysfunction, including heart failure with reduced ejection fraction and hypertrophic cardiomyopathy or HCM.

In addition, we continue to gather data to inform potential progression of our neuromuscular program.

As has been our history, we continue to follow the science.

Robert I. Blum: In recent weeks, we announced the completion of patient enrollment in GALACTIC-HF, our Phase 3 study of Omicamptive McCarville. This represents a major milestone for us and for patients with heart failure with reduced ejection fracture. It also represents a significant milestone in our collaboration with Amgen, which dates back to 2006. Our team takes great pride in this long-standing collaboration and completing enrollment in line with the defined trial objectives. It's a testament to the diligent work, cooperation, and oversight of both companies working effectively alongside the Global Clinical Trial Site Network. In the last quarter, we also continued site activation and enrollment in METEORIC-HF, the second Phase 3 clinical trial of Omicamptin-McCarville, and we remain on track with timelines and other objectives for that ongoing trial. Fady will elaborate on that in a moment.

In recent weeks, we announced the completion of punch in enrollment in Galactic HF, our phase three study of Omecamtiv Mecarbil.

This represents a major milestone for us and for patients with heart failure with reduced ejection fraction.

It also represents a significant milestone under our collaboration with Amgen, which dates back to 2006.

Our team takes great pride in this long standing collaboration and completing enrollment in line with the differing trial objective. It's a testament to the diligent work cooperation and oversight of both companies are working effectively alongside the global clinical trial site network.

In the last quarter. We also continued site activation and enrollment immediate work each of the second phase three clinical trial of Omecamtiv Mecarbil and we remain on track with timelines and other objectives for the ongoing trial, Saudi will elaborate on that in a moment.

Importantly, we also kept pace and advanced CK two seven for our wholly owned cardiac myosin inhibitor.

Robert I. Blum: Importantly, we also kept pace with and advanced CK274, our wholly owned cardiac myosin inhibitor. We're in the final stages of the Phase 1 study of CK274 in healthy volunteers and have, in parallel, been planning to begin our Phase 2 trial in patients with obstructive HCM. We expect that to get underway in the fourth quarter of this year.

We're in the final stages of the Phase one study of CK 274 in healthy volunteers.

And how much in parallel been planning to begin our phase two trial in patients with obstructive H.C., we expect that to get underway in the fourth quarter of this year.

Robert I. Blum: We remain enthusiastic about progressing this program, especially given the high unmet need for patients living with HCM. We believe CK274 represents a potential next-in-class drug candidate that may demonstrate a distinct clinical profile consistent with what we have seen in our preclinical work, and that may translate into a potential therapy enabling optimized dosing, titration, and symptom relief for HCM patients. On the neuromuscular front, Andy will elaborate on progress made towards potentially advancing rel-deceptive in future clinical trials in each of ALS or SMA patients. We were pleased to recently announce that the European Medicines Agency has granted orphan medicinal product designation to Reldeceptive for the treatment of SMA. As we continue to pioneer the field of muscle pharmacology in both cardiovascular and neuromuscular diseases, we look forward to potentially sharing results from our ongoing clinical trials and delivering on our mission to bring new medicines to patients suffering from diseases of muscle weakness and impaired muscle function. With that, I'll now turn the call over to Fady, who will elaborate on our cardiovascular program. Thanks, Robert.

We remain enthusiastic about progressing this program, especially given the high unmet need for patients living with H.C.

We believe CK 274 represents a potential next in class drug candidates that'd be demonstrated a distinct clinical profile consistent with what we have seen in our preclinical work and that may translate into a potential therapy and they believe optimized dosing nitration and symptom relief for HCM patients.

On the neuromuscular front.

Andy will elaborate on progress made towards potentially advancing real disruptive in future clinical trials in each of aeolus or Esa nave patients.

We were pleased to recently announced that the European Medicines agency has granted orphan medicinal product designation to rail disruptive for the treatment of estimate.

As we continue to pioneer the field of muscle pharmacology in both cardiovascular and neuromuscular diseases, we look forward to potentially sharing results from our ongoing clinical trials and delivering on our mission to bring new medicines to patients suffering from diseases of muscle weakness and impaired muscle function.

With that I'll now turn the call over to Saudi and who will elaborate on our cardiovascular programs.

Thanks, Robert before I get into specific updates I'd like to take a moment to reflect on the productivity and promise of our pipeline.

Fady Ibraham Malik: Before I get into specific updates, I'd like to take a moment to reflect on the productivity and promise of our pipeline. We pioneered the pharmacology of muscle function and continue to build our leadership with an expanding and advancing clinical pipeline of novel modulators of sarcomere contractility, both activators and inhibitors. This work encompassed screening many millions of compounds, profiling thousands of hit compounds, optimizing and characterizing hundreds of distinct chemical theories, and conducting dozens of clinical trials. We've learned a lot along the way about how to best modulate the sarcomere for potential therapeutic benefit and have developed a profound respect for the importance of prioritizing pharmacokinetics and pharmacodynamics of our drug candidates in this area. As Robert mentioned, we recently completed enrollment in GALACTIC-HF, the Phase III Cardiovascular Outcomes Clinical Trial of Omecamtin-McCarville being conducted by Amgen under our collaboration. Galactic HF follows 18 prior clinical trials that set the stage for this important outcomes trial and informed the dosing, patient inclusion, and exclusion criteria, and endpoints that we and Amgen selected for the study. There are more than 8,200 patients enrolled at over 1,000 sites across 35 countries.

We pioneered the pharmacology of muscle function and continue to build our leadership with an expanding and advancing clinical pipeline of novel modulators of sarcomere contractility, those activators and inhibitors.

This work encompass star screening many millions of compounds.

Profiling thousands of head compounds.

Optimizing and characterizing hunger, it's a distinct chemical series and conducting dozens of clinical trials.

We've learned a lot along the way about how to best.

[noise], some modulators sarcomere for potential therapeutic benefit and have developed a profound respect to the importance of prioritizing pharmacokinetics and pharmacodynamics of our drug candidates in this area.

As Robert mentioned, we recently completed enrollment and Galactic HF the phase three cardiovascular outcomes clinical trial of Omecamtiv Mecarbil being conducted by Amgen under our collaboration.

Galactic HF follows 18, prior clinical trials, which sets the stage for this important outcomes trial.

And inform the dosing patient inclusion and exclusion criteria and endpoints that we and Amgen selected for the study.

With more than 8200 patients enrolled at over a thousand sites across 35 countries.

Fady Ibraham Malik: Galactic HF is now among the largest heart failure clinical trials ever conducted. We're pleased with the outstanding contributions of our site investigators and study coordinators and encourage you to ensure that we achieve the intended balance of inpatients and outpatients with excellent global representation. Specifically, we enrolled approximately 40% of the patients in the U.S., Canada, Western Europe, South Africa, and Australia; 33% in Eastern Europe and Russia. 19% in Latin America and 8% in Asia.

Galactic HF is now among the largest heart failure clinical trials ever conducted.

We're pleased with the outstanding contributions of our site investigators in the study coordinators and encouraged that we achieved the intended balance of inpatient and outpatient with excellent global representation.

Specifically, we enrolled approximately 40% of the patients from the U.S., Canada, Western Europe , South Africa, and Australia, Australia Asia.

33% and eastern Europe and Russia.

19% in Latin America, and 8% in Asia.

Fady Ibraham Malik: Approximately 25% of the patients in GALACTIC-HF were hospitalized at randomization, which is consistent with the protocol specifications. As you may recall, in March 2019, the Data Monitoring Committee conducted the first interim analysis of Galactic HF, which included consideration of pre-specified criteria of futility. Upon review of the data, the DMC recommended the trial continue without changes to its conduct.

Approximately 25% of the patience and Galactic HF were hospitalized at randomization, which is consistent with the protocol specification.

As you May recall in March 2019, the data monitoring committee conducted the first interim analysis in Black <expletive> HF, which included consideration of pre specified criteria of futility.

Upon review of the data the DMC recommended the trial continue without changes to its conduct.

Fady Ibraham Malik: Utility analysis was triggered once a pre-specified number of cardiovascular deaths stipulated by the trial's protocol had occurred. With enrollment now complete, the next milestone will be the second planned interim analysis, which includes an assessment of the potential for superiority projected to occur in the first half of 2020. Also during the quarter, we continued site activation and enrollment in Meteoric-HF, our second phase 3 trial of Omicamptin-McCarbyl, which is designed to evaluate the effect of treatment with Omicamptin-McCarbyl compared to placebo on exercise capacity as determined by cardiopulmonary exercise testing following 20 weeks of treatment. This trial is being conducted by Cytokinetics under our collaboration with Amgen. While it is still early days, enrollment is on track, and sites are executing the protocol well.

A futility analysis was triggered once a pre specified number of cardiovascular death stipulated by the trial protocol had occurred.

With enrollment now complete the next milestone will be the second planned interim analysis, which includes an assessment for the potential for superiority projected to occur in the first half of 2020.

Also during the quarter, we continued site activation and enrollment and meteoric HF, our second phase three trials on the Captain Mccarville, which is designed to evaluate the effect of treatment with omecamtiv mecarbil compared to placebo on exercise capacity as determined by cardiopulmonary exercise testing following 20 weeks of treatment.

This trial is being conducted by Cytokinetics under our collaboration with Amgen.

While it is still early days enrollment is on track and sites are executing the protocol well the quality. The initial exercise tests conducted by the sites and reviewed by the core lab has been high which is encouraging and we look forward to meeting our goal to activate the majority of participating sites. This year distributed across the U.S., Canada and Europe .

Fady Ibraham Malik: The quality of the initial exercise test conducted by the sites and reviewed by the Core Lab has been high, which is encouraging, and we look forward to meeting our goal to activate the majority of participating sites this year distributed across the U.S., Canada, and Europe. As previously stated, we're seeking to have results available around the same time the Galactic HF is anticipated to read out in 2021. Now turning to AMG-594, our novel selective oral small molecule cardiac troponin activator that was discovered under our joint research program with Amgen. AMG-594 was designed to show differential pharmacology in the cancer of McCarville, and its advancement further underscores our leadership in muscle biology. In the second quarter, Amgen continued to conduct this is a Phase I clinical study of AMG-594. This study includes single and multiple ascending dose cohorts to assess the safety and tolerability of AMG-594 in healthy volunteers and its potential to increase cardiac function.

As previously stated we are seeking to have results available around the same time, the galactic HF is anticipated to read out and 2020 one.

Now turning to AMG fivenine for our novel selective oral small molecule cardiac proponent activator that was discovered under our joint research program with Amgen.

AMG Fivenine for was designed to show differential pharmacology, Omecamtiv mecarbil and its advancement further underscores our leadership in muscle biology.

In the second quarter Amgen can continue to conduct.

The phase one clinical study of AMG 594.

This study include single and multiple ascending dose cohorts to assess the safety and Tolerability of AMC fivenine for in healthy volunteers and its potential to increase cardiac function.

Fady Ibraham Malik: We expect the study will continue throughout 2019, and we have been working closely with Amgen to develop a potential Phase II clinical program and plan. Now moving to our Cardiac Myosin Inhibitor Program, in the second quarter, we continued the conduct of the Phase I First in Human Study of our Cardiac Myosin Inhibitor, CK274. This study and those with healthy participants will soon be coming to a close, and we're pleased that an abstract describing the results has been accepted as a poster presentation at the HFSA 23rd Annual Meeting to be held September 13th through 16th. As you know, we are developing this investigational medicine for the potential treatment of hypertrophic cardiomyopathy and expect to advance this and other compounds in a broad development program.

We expect this study will continue throughout 2019 and I've been working closely with Amgen to develop a potential phase two clinical program and plan.

Now moving to our cardiac myosin inhibitor program in the second quarter. We continued the conduct of the phase one first in human study of our cardiac myosin inhibitor CK two some for.

This study in healthy participants will soon be coming to a close and we're pleased that an abstract describing the results has been accepted as a poster presentation at the HFSA 20, Threerd annual meeting to be held September 13 through 16.

As you know we are developing this investigational medicine for the potential treatment of hypertrophic cardiomyopathy and expect to advance this and other compounds in a broad development program.

Fady Ibraham Malik: We expect that the Phase I data will lend support to what we have seen emerging in our preclinical work, that is, a profile that may distinguish it as a next-in-class drug candidate. We believe its pharmacokinetics may optimize the time to reach target dose levels and provide both rapid symptom relief and reversibility. In connection with this profile for this next-in-class drug candidate, last week, we presented preclinical data at the American Heart Association's Basic Cardiovascular Sciences Scientific Session. It showed that CK274 decreased cardiac contractility in vitro and in vivo, suggesting that this cardiac myosin inhibitor may address the underlying hypercontractility of the cardiac sarcomere in HCM patients. This was the first presentation of data relating In vitro studies showed that CK274 selectively inhibited cardiac myosin activity in a concentration-dependent manner and reduced fractional shortening, a measure of cardiac contractility, without any effect on the cardiac calcium transient. Similarly, veto studies in healthy animals demonstrated that CK274 decreased cardiac contractility in a dose-related fashion. In a mouse model of hypertrophic cardiomyopathy, single doses of CK274 reduced fractional shortening in a dose-related fashion, and its effects appeared reversible within 24 hours after administration of a single dose of CK274.

We expect that the phase one data will lend support to what we have seen.

Emerging in our preclinical work that is a profile that may distinguish it as a next in class drug candidate.

We believe its pharmacokinetics may optimize the time to reach target dose level and provide both rapid symptom relief and reversibility.

In connection with that profile for this next in class drug candidate last week, we presented preclinical data at the American Heart Association basic cardiovascular Sciences scientific sessions.

Which showed that CK 274 decreased cardiac contractility in vitro and in vivo, suggesting that this cardiac myosin inhibitor may address the underlying hyper contractility of the cardiac sarcomere in HCM patients.

This was the first presentation of data relating to CK 274 at a medical meeting.

In vitro studies showed that CK two some four selectively inhibited cardiac myosin activity and a concentration dependent manner and reduced fractional shortening and measure cardiac contractility without any effect on the.

Cardiac calcium transient.

Similarly, envy those studies in healthy animals demonstrated that teekay to seven four decreased cardiac contractility in the dose related fashion.

In a mouse model of hypertrophic cardiomyopathy single doses of CK, two seven for reduced fractional shortening and a dose related fashion and its effects appeared reversible within 24 hours. After administration of a single dose of CK 274.

Andy Wolfe: We believe these data support the distinctive therapeutic hypotheses relating to both onset of action and reversibility of effect. As we wrap up the Phase I study, we're also preparing for an international Phase II trial to begin in the fourth quarter of the year. Toward that end, we have identified leading clinical sites to participate, and we've assembled an enthusiastic steering committee, which includes the foremost experts in HCM. We are pleased with the feedback we continue to receive from leaders in the field about our approach and the strong interest they have to participate in the clinical trials program of this potential new therapy. And now, I'll turn the call over to Andy to provide an update on rail deceptive. Thanks, Fady.

We believe these data support the distinctive therapeutic hypotheses relating to both onset of action and reversibility of effect.

As we wrap up the phase one study. We're also preparing for an international phase two trial to begin in the fourth quarter of the year.

Toward that end, we have identified leading clinical sites to participate and we've been as we've assembled an enthusiastic steering committee, which includes the foremost experts in HCM.

We are pleased with the feedback we continue to receive from leaders in the field about our approach in the strong interest to having to participate in the clinical trials program of this potential new therapy.

And now I will turn the call over to Andy to provide an update on relative sensitive.

Thanks Patty.

During the quarter, we focused on planning for the potential advancement of world assented into additional clinical trials.

We are pleased to have identified what we believe to be potential paths forward in each of the Ela and SMB and continue to discuss how best to approach regulatory authorities and to develop protocols timelines and budgets.

Andy Wolfe: During the quarter, we focused on planning for the potential advancement of rural deceptive into additional clinical trials. We are pleased to have identified what we believe to be potential paths forward in each of ALS and SMA and continue to discuss how best to approach regulatory authorities and to develop protocols, timelines, and budgets. As we have previously stated, we believe that the data generated from our Phase II trials in each of the SMA and ALS support progression to potential registration programs. We recognize that both patient communities are in urgent need of new therapeutic options that may be addressed by muscle-directed treatment. Importantly, the introduction of new therapies in SMA has changed the natural history of these diseases. However, while infants and children treated with these new therapies are fortunately living longer than ever before, they are still expected to struggle with persistent residual muscle weakness that impacts their ability to perform activities of daily living.

As we have previously stated we believe that the data generated from our phase two trial in each of SDMA and the LSW support progression to potential registration programs.

We recognize that both patient communities are an urgent need of new therapeutic options that may be addressed by muscle directed treatments.

Importantly, the introduction of new therapies in SNA has changed the natural history of these diseases.

Well infants and children treated with these new therapies are fortunately living longer than ever before they are still expected to struggle with persistent residual muscle weakness that impacts their ability to perform activities of daily living.

We believe relative sometimes maybe complementary to these new treatments by addressing this residual muscle weakness.

In fact, we recently presented data from two preclinical studies of relevance tempted at the 2019 annual Cure SDMA conference that showed the addition of relative tempted to treatment with either of two different S M and up regulators, new centers open and SM and C and analog.

Andy Wolfe: We believe RAL-DECEMTIVE may be complementary to these new treatments by addressing this residual muscle weakness. In fact, we recently presented data from two preclinical studies of Raldasemtev at the 2019 Annual CURE SMA Conference that showed the addition of Raldasemtev to treatment with either of two different SMN upregulators, nusinersen and SMNC1, and analog teristepla Data from these preclinical studies suggest that RAL-deceptive therapy may complement SMN-directed therapies to further improve muscle function, especially for routine activities that may be fatiguing and don't require maximum exertion.

Tourists to plan significantly increased the muscle force in a mouse model of SDMA.

Data from these preclinical studies suggest that receptors may complement Esa men directed therapies to further improve muscle function, especially for routing activities that maybe fatiguing and don't require maximum exertion.

As Steve therapy has become the standard of care and it will be important to understand what the new baseline looks like for patients and what our appropriate endpoints for ambulatory and non ambulatory patients.

We are collaborating with clinical experts in the field as well as patients.

Advocates and health technology assessors to determine our clinical strategy and study designs.

While we continue to assess the landscape and Thats I may we believe there may be greater urgency, an unmet need and less given a lack of effective treatment options.

Andy Wolfe: As these therapies become the standard of care, it will be important to understand what the new baseline looks like for patients and what are appropriate endpoints for ambulatory and non-ambulatory patients. We are collaborating with clinical experts in the field as well as patients, advocates, and Health Technology Assessors to determine our clinical strategy and study design.

During the quarter, we drafted a protocol synopsis for a next phase three trial in patients with LSW and our scheduling meetings to ensure that our proposed approach is sound and alliance with regulatory patient and payer needs.

As you can imagine this will take some time to get it right. So we do not expect to begin the next trial and so perhaps the second half of 2020.

Andy Wolfe: While we continue to assess the landscape in SMA, we believe there may be greater urgency and unmet need in ALS given the lack of effective treatment options. During the quarter, we drafted a protocol synopsis for our next Phase III trial in patients with ALS and are scheduling meetings to ensure that our proposed approach is sound and aligns with regulatory, patient, and payer needs. As you can imagine, this will take some time to get it right, so we do not expect to begin the next trial until perhaps the second half of 2020.

Finally under our collaboration with the specialist. We also continued preclinical development of our fast skeletal muscle ultrapar and half innovator UK fixed so one.

As well as our joint research program focused on pursuing other next generation skeletal muscle activators now I will turn the call over to Robert want to update you on our financials.

Thank you Andy.

I'll first provide an update on cash revenue and spending and then Ching will review our corporate development strategy.

More detailed on our actual results are included in the press release itself.

We ended the second quarter with 175.1 million in cash and investments.

Robert C. Wong: Finally, in our collaboration with the Spellets, we also continued preclinical development of our fast skeletal muscle troponin activator, CK601, as well as our joint research program focused on pursuing other next-generation skeletal muscle activators. Now, I will turn the call over to Robert Wong to update you on our financial... Thank you, Andy.

Our revenue in Q2 2019 came from our strategic alliances with a stellar from Amgen.

For a stellar we continue to recognize revenue for reimbursement of our research activities as well as development cost we incurred related to fortitude less for Amgen, we recognize revenue associated with their reimbursement of our costs for development expenses related to meteoric detail.

Robert C. Wong: I'll first provide an update on cash, revenue, and spending, and then Ching will review our corporate development strategy. More details on our actual results are included in the press release itself. We ended the second quarter with $175.1 million in cash and investment. Our revenue in Q2 2019 came from our strategic alliances with Astellas and Amdahl. For Astellas, we continue to recognize revenue for reimbursement of our research activities as well as development costs we incurred related to Fortitude ALS. For Amgen, we recognize revenue associated with their reimbursement of our costs for development expenses related to Meteoric HS. Our revenues include both cash and non-cash revenue recognized under ASC 606, the new accounting rules for revenue recognition. Our second quarter 2019 R&D expenses increased to $24 million from $21.6 million in the second quarter of 2018.

Revenues include both cash and noncash revenue recognized on their HFC six all six the new accounting rules for revenue recognition.

Our second quarter 2019, R&D expenses increased to $24 million from $21.6 million in the second quarter of 2018, primarily because of the increased activity related to meteoric HF and CK 274, offset in part by lower spending related to our neuromuscular activity.

Nearly half of our R&D expenses were attributable to our cardiovascular programs as expected given activity for meteoric HF and the cardiac myosin inhibitor program.

Approximately 30% of our expenses were attributable to our skeletal muscle program and the remainder of our R&D expenses were related to our early research activities.

Our second quarter 2019, Gionee expenses were $9.8 million up from 8 million in Q2, 2018, due primarily to increase outside legal expenses and higher personnel related costs.

And now I will turn the call over to King who will review our corporate development strategy.

Thanks, Robert as Robert mentioned.

We ended the second quarter was 175 million in cash.

Which represents approximately two years of forecast based on our 2019 guidance of 85 to 90 million net cash burn rate.

As we have previously stated our strategy remains to manage our cash prudently through the expected readout of the results from Galactic HF in 2021.

Robert C. Wong: primarily because of the increased activity related to meteoric HF and CK274, offset in part by lower spending related to our neuromuscular activity. However, nearly half of our R&D expenses were attributable to our cardiovascular programs, as expected, given the activity for meteoric HF and the cardiac myosin inhibitor program. Approximately 30% of our expenses were attributed to our skeletal muscle programs, and the remainder of our R&D expenses were related to our early research activities. Our second quarter 2019 G&A expenses were $9.8 million.

During the quarter, we executed on multiple strategies to meet the objective, including our continuing to engage in potential collaboration and project financing discussions relating to our cardiac myosin inhibitor program as potential ways to access non dilutive capital.

We also restructured our short term goals kept alone.

To extend the term of the payments beyond 2020.

Enabling those nearer term dollars to be invested in slot business. This year.

I will remind you that we remained potentially eligible for pre commercialization milestone payments under our existing collaborations as well as additional reimbursement of sponsored research and development activities in 2019.

Robert C. Wong: Up from $8 million in Q2 2018, due primarily to increased outside legal expenses and higher personnel-related costs. And now, I will turn the call over to Ching, who will review our corporate development strategy. Thanks, Robert.

Our balance sheet remains strong and we continue to see non diluted financing to access additional capital and extend our cash runway.

So kinetics is growing and our pipeline is expanding and progressing well we remain vigilant to carefully deployed capital to that program that we believe are most likely to provide the both the best returns on investment.

Ching W. Jaw: As Robert mentioned, we ended the second quarter with $175 million in cash, which represents approximately two years of forward cash based on our 2019 guidance of 85 to 90 million net cash burn rate. As we have previously stated, our strategy remains to manage our cash prudently through the expected readout of the results from Galactic HS in 2021. During the quarter, we executed multiple strategies to meet that objective, including continuing to engage in potential collaboration and project financing discussions relating to our cardiac myelosin inhibitor program as potential ways to access non-dilutive capital. We also restructured our short-term growth capital loan to extend the term of repayment beyond 2020.

Both to bettering patient care as well as to delivering the best value to shareholders.

To that point, we recently kicked off our annual strategic planning process, which this year will be focused on optimal positioning for growth and his prior authorization.

We are in an enviable position with a larger and still growing pipeline.

With potential multiple commercial launches in the next three to five years.

So the strategic plan, we will focus on how best positioned the company to maximize shareholder value over the near to medium term timeframe.

And with that I will now turn the call back over to Rob. Thank you Jim.

So it's clearly been a very productive quarter for sort of kinetics.

Ching W. Jaw: Enabling those nearer-term dollars to be invested in our business. I will remind you that we remain potentially eligible for pre-commercialization milestone payments under our existing collaborations, as well as additional reimbursement of sponsored research and development activities in 2019. Our balance sheet remains strong, and we continue to seek non-dilutive financing to access additional capital and expand our cash runway.

And we remain energized about our prospects as we look forward into the second half of 2019.

This year, we have reinforced that we would have three key events shaping the complexion of the company.

First was the first interim analysis in Galactic HF, which as you know resulted in our continuing the trial with no changes to the protocol.

Second was the announcement of data from four to two days or less which we believe supported progression to a potential phase three trials that may enable registration.

Ching W. Jaw: Cytokinetics is growing, and our pipeline is expanding and progressing, but we remain vigilant to carefully deploy capital to the programs that we believe are most likely to provide the best returns on investment, both for bettering patient care as well as to delivering the best value to shareholders. To that point, we recently kicked off our annual strategic planning process, which this year will be focused on optimal positioning for growth and prioritization. We are in an enviable position with a larger and still growing pipeline, with potential for multiple commercial launches in the next three to five years. So the strategic plan will focus on how best to position the company to maximize shareholder value over the near to medium term time frame. And with that, I will now turn the call back over to Robert. Thank you, Ching.

And thirdly, the data from the Phase one study of CK, two seven for which we will present at HFSA.

And we believe support planning to progress into phase two.

We believe for those three events, we have gone three for three.

I'm pleased with our teams execution and believe we enter the second half of the year with clarity of focus and purpose.

As Ching mentioned.

This summer marks the start of our 2020 strategic planning process and we look forward to charting the next phase of corporate development to prepare for scaling the company's operations towards potential commercialization.

At the same time, expanding our footprint in muscle biology.

Robert I. Blum: So it's clearly been a very productive quarter for cytokinetics, and we remain energized about our prospects as we look forward into the second half of 2019. This year, we've reinforced that we would have three key events shaping the complexion of the company. The first was the first interim analysis in GALACTIC-HF, which, as you know, resulted in our continuing the trial with no changes to the protocol. Second, was the announcement of data from Fortitude ALS, which we believe supported progression to a potential phase 3 trial that may enable registration. And thirdly, the data from the Phase 1 study of CK274, which will be presented at HFSA and we believe support planning to progress into Phase 2. We believe for those three events, we have gone three for three.

Towards that end, we are excited about continued progress in our muscle biology research and we look forward to potentially one or two new drug candidates entering clinical trials in 2020 as well as the advancement of our other programs further reinforcing our leadership.

In the meantime, we remain dedicated to advancing research education support and awareness for the patient populations we serve.

During the quarter, we announced a continuation of our partnership with the less association in the fight against LLS with the renewal of our goal global sponsorship of the national walks to the feet they allow us.

Our premier level National Aeolus advocacy conference sponsorship as well as our platinum level sponsorship for initiatives led by the LSW Association Golden West Chapter.

We're doing much the same in the areas of Esa may HCM and the other cardiovascular disease communities that means so much to us and we look forward to sharing more details about those activities on a rolling forward basis.

Robert I. Blum: I'm pleased with our team's execution and believe we enter the second half of the year with clarity of focus and purpose. As Ching mentioned, this summer marks the start of our 2020 strategic planning process. And we look forward to charting the next phase of corporate development to prepare for scaling the company's operations towards potential commercialization, while at the same time, expanding our footprint in muscle biology. Towards that end, we're excited about continued progress in our muscle biology research, and we look forward to potentially one or two new drug candidates entering clinical trials in 2020, as well as the advancement of our other programs further reinforcing our leadership. In the meantime, we remain dedicated to advancing research, education, support, and awareness for the patient populations we serve. During the quarter, we announced the continuation of our partnership with the ALS Association in the fight against ALS with the renewal of our Gold Level Sponsorship of the National Walks to Defeat ALS. Our Premier Level National ALS Advocacy Conference Sponsorship, as well as our Platinum Level Sponsorship for initiatives led by the ALS Association Golden West Chapter

Our commitment to bring novel muscle biology, directed therapies to patients in need has never been stronger and we look forward to continuing to update you on our progress.

Now, let me recap our expected milestones for the remainder of 2019.

For Omecamtiv Mecarbil, we expect to continue to conduct galactic HF and meteoric HF in patients with heart failure throughout 2019.

For CK 274, we expect data from the Phase one study of CK 274 in healthy subjects in this third quarter of 2019, and we expect to begin a phase two trial in the fourth quarter of this year.

For AMC Fivenine for we expect at Amgen will continue to conduct the phase one study of AMG five nine Ford throughout 2019.

For real disruptive.

We will continue to advance planning for potential future trials.

And so may.

Robert I. Blum: We're doing much the same in the areas of SMA, HCM, and the other cardiovascular disease communities that mean so much to us, and we look forward to sharing more details about those activities on a rolling forward basis. Our commitment to bring novel muscle biology-directed therapies to patients in need has never been stronger, and we look forward to continuing to update you on our progress. Now, let me recap our expected milestones for the remainder of 2019. For Omicamptive McCarble, we expect to continue to conduct galactic HF and meteoric HF in patients with heart failure throughout 2019. For CK274, we expect data from the Phase 1 study of CK274 in healthy subjects in the third quarter of 2019, and we expect to begin a Phase 2 trial in the fourth quarter of this year.

We're currently in discussions with the still us regarding amending the terms of our collaboration agreement including for rail deceptive.

The level of potential funding and the share of commercialization returns.

As well as which company would be responsible for development and commercialization.

For preclinical research, we expect to continue research activities under our joint Research program with US still is directed to the discovery of next generation skeletal muscle activators.

Well 2019.

And we also expect to continue our other muscle biology focused research, including the expansion of our research activities beyond the contractility of muscle towards the energetics of muscle.

And operator with that we can now open up the call to questions. Please.

Ladies and gentlemen, if you would like to ask a question. During this time. Please press Star then the number one on your telephone keypad again Thats Star One and your first question comes from Joe Pantginis of H.C. Wainwright.

Robert I. Blum: For AMG-594, we expect that Amgen will continue to conduct the Phase I study of AMG-594 throughout 2019, and for Relative Symptoms, will continue to advance planning for potential future trials in ALS and SMA. We're currently in discussions with Estellas regarding amending the terms of our collaboration agreement, including for Relative, the level of potential funding and the share of commercialization returns, as well as which company would be responsible for development For preclinical research, we expect to continue research activities under our joint research program with Astellas directed to the discovery of next-generation skeletal muscle activators throughout 2019. We also expect to continue our other muscle biology-focused research, including the expansion of our research activities beyond the contractility of muscle towards the energetics of muscle. Operator, with that, we can now open up the call to questions, please.

Hi, Joe.

Hey, everyone. Good afternoon.

I want to start off first may be merging two of my questions I think and I don't want to overstate. This but I think you projected a very important signal today with regard to real deceptive if I heard Andy correctly, saying you believe you identified a path for both lessen SDMA I think even some of the discussions we've been having is yes.

Much has been the focus and its just constantly questioning about what might be happening with SM may. So I think this is.

Very welcome announcement today.

So I was just curious is there anything else you can say with regarding these pads I know, it's early and you are not looking you're looking to start studies about a year from now and then secondly.

To your comment.

This sounds like you might be vying for.

You know more participation based on your comment of renegotiating your deal with a stellar so I don't know if I'm over reaching there.

Well, Joe very good questions Firstly with respect to estimate yes, you're right having spent a lot of time with advocacy groups and clinical opinion leaders.

Operator: Ladies and gentlemen, if you would like to ask a question during this time, please press star, then the number one on your telephone keypad. Again, that's star one. And your first question comes from Joe Pantginis of H.C. Wainwright.

We do think we're identifying a path forward in SMB and I'll ask Andy to comment on that in a moment.

But at the same time I Hope you also heard him say that we believe that the urgency with regard to proceeding forward a less may supersedes out of this may and there are still things we want to learn in SDMA, especially as gene therapy down makes its mark in that marketplace, and we don't want to make certain that we can understand the baseline deficit in patients.

Joseph Pantginis: Hey everyone, good afternoon. I want to start off by maybe merging two of my questions. I think, and I don't want to overstate this, but I think you projected a very important signal today with regard to rel-deceptive. If I heard Andy correctly, you believe you identified a path for both ALS and SMA. I think even some of the discussions we've been having are, you know, obviously ALS has been the focus, and we're constantly questioning about, you know, what might be happening with SMA. So I think this is a very welcome announcement. So I was just curious, is there anything else you can say regarding these paths? I know it's early, and you're looking to start studies about a year from now. And then secondly, to your comment, this sounds like you might be vying for, you know, more participation based on your comment about renegotiating your deal with Estellas. I don't know if I'm overreaching there.

So as to properly designed in power a clinical trial of course I'll come back to your second question. After Andy has a chance to speak.

So I'll just say I think when we talk about a pathway forward to a large extent, we're indicating that we believe as I said the phase two studies.

Support progressing at the data from them were sufficiently.

Demonstrative of a therapeutic effect that.

Well the Cemp is worth further study in both disease areas.

To get more specific than that its difficult at this point as we mentioned.

The landscape in estimate in particular is changing.

And we're going to need a lot of feedback from.

Robert I. Blum: Joe, very good questions. Firstly, with respect to SMA, yes, you're right. Having spent a lot of time with advocacy groups and clinical opinion leaders, we do think we're identifying a path forward for SMA, and I'll ask Andy to comment on that in a moment. But at the same time, I hope you also heard him say that we believe that the urgency with regard to proceeding forward in ALS may supersede that of SMA, and there are still things we want to learn about SMA, especially as gene therapy now makes its mark in that marketplace, and we want to make certain that we can understand the baseline deficit in patients so as to properly design and power a clinical trial. I'll come back to your second question after Andy has a chance to speak.

Again as we've mentioned.

Key opinion leaders advocacy groups health technology, assessors and so forth.

Before we have a very developed.

Idea what the endpoints in particular should be I think we're pretty satisfied with the data from our phase two study that an ambulatory patients a six minute walk test is a good end point, but we are less clear how we might evaluates the drug in non ambulatory patients. So there's still some more homework to do there.

As you asked in the second part of your question with regard to our collaboration with Astellas were socializing all of this together with the stylist and engaging with them through these interruptions.

Robert I. Blum: So, I'll just say, you know, I think when we talk about a pathway forward, to a large extent, we're indicating that we believe, as I said, the Phase II studies Support Progressing The data from them were sufficiently demonstrative of a therapeutic effect that SEMPTIV is worth further study in both disease areas. To get more specific than that, it's difficult at this point; as we mentioned, the landscape in SMA, in particular, is changing. And we're going to need a lot of feedback from, again, as we've mentioned, key opinion leaders, advocacy groups, health technology assessors, and so forth, before we have a very developed idea of what the endpoints in particular should be. I think we're pretty satisfied with the data from our Phase 2 study that in ambulatory patients, a 6-minute walk test is a good endpoint, but we are less clear about how we might evaluate the drug in non-ambulatory patients.

And discussing therefore, what the protocols would look like with the timelines and budgets would look like.

And yes, you are right. We also noted with this.

Earnings announcement that we are going to be discussing with them how to amend our collaboration agreement to enable the path forward. So thats something where I think we can say much more about the other then it may result in changes as it pertains to things that.

To this point has had.

Our co funding arrangement, that's been specified and rights and responsibilities that have been.

Clarified for phase, one and phase two for phase three we expect that is still to change.

Understood No thats very helpful. Helpful. Thank you Robert and then if I could just follow up quickly with regard to 274, obviously you put out a lot of preclinical data recently, so with regard to animal model and these dose exposure levels can you, obviously a might be over reaching here again too, but can you describe any potential read through with regard to clinical benefit.

Andy Wolfe: So there's still some more homework to do there. As you asked in the second part of your question with regard to our collaboration with Astellas, we're socializing all of this together with Astellas and engaging with them through these interactions and discussing, therefore, what the protocols would look like, what the timelines and budgets would look like. Yes, you're right.

Based on these clinical updates on these preclinical data in animals, but more importantly, and this could be apples to oranges I'm not sure.

A little compare and contrast, with regard to Mount a camp them because im sure Thats say on an ongoing question that's on the street right now.

Yeah, we're not going to.

Compared to more of a tempted on the service earnings call, but I will ask study to respond to your question and all.

Maybe follow up afterwards.

Yes, I mean, the data I think supported the.

Robert I. Blum: We also noted in this earnings announcement that we are going to be discussing with them how to amend our collaboration agreement to enable the path forward. So that's something where I think we can't say much more about that other than it may result in changes as it pertains to things that, to this point, have had a co-funding arrangement that's been specified, and rights and responsibilities that have been clarified for Phase 1 and Phase 2. For Phase 3, we expect that to still change.

Premise lives, which we embarked upon.

Optimizing CK 2741 was that.

The pharmacokinetics lend themselves to a rapid onset that also a reversibility of effect that was consistent with his exposure that we.

Maximize if you will the shallow so the exposure response relationships.

As best as we could and with this mechanism of actions.

And that we have evidence of effect in a disease model that doesn't recur recapitulate, the human condition perfectly but.

Joseph Pantginis: I understand. No, that's very helpful. Thank you, Robert.

But showed that the exposure response relationship and mouse model of hypertrophic scar democracy was essentially the same as it was in the normal nice that we characterize so all of those studies provided us.

Joseph Pantginis: And then if I could just follow up quickly with regard to 274. Obviously, you have put out a lot of preclinical data recently. So with regard to animal models and these dose exposure levels, can you, obviously, I might be overreaching here again, too, but can you describe any potential read through with regard to clinical benefit based on these preclinical data in animals? But more importantly, and this could be apples to oranges, I'm not sure, you know, a little compare and contrast with regard to Mavicantum, because I'm sure that's an ongoing question that's on the street right now.

The data that justify moving forward into humans and ultimately.

Patients.

You know the preclinical data is that.

Were presented a week or two ago. They elaborate on things we had already been sharing at our R&D day last fall.

And what ultimately I think you are going to be most interested in or the phase one data.

Which now today, we are announcing you will be seeing in September .

What.

We can share with you is already having.

Seen enough of those data to commit to phase two we believe the phase one data will support.

And recapitulate things, we believe knowing what we did with the preclinical data.

Fady Ibraham Malik: Yeah, we're not going to compare to Mava Kempton on this earnings call, but I will ask Fady to respond to your question, and I'll maybe follow up afterwards. Yeah, I mean, the data I think supported the premise with which we embarked upon. Optimizing CK274, one was that the pharmacokinetics lended themselves to rapid onset, but also a reversibility of effect that was consistent with its exposure that we, Maximize, if you will, the shallowness of the exposure-response relationship as best as we could with this mechanism of action, and that we have evidence of effect in a disease model that doesn't recapitulate the human condition perfectly, but shows that the exposure-response relationship in that mouse model of hypertrophic cardiomyopathy was essentially the same as it was in the normal mice that we characterized.

That this compound has properties that we believe will render it.

Beneficial in patients as we move into phase two so.

How will the drug.

Behaves is very very important as we've spoken a few times.

I think we're seeing in the preclinical data and in the phase one data consistent story.

Excellent thanks very much for the.

Thank you.

And your next question comes from Jason Butler from JMP Securities.

Hi, Jason Hi, Hi, Robert Thanks for taking the questions.

Let me just add a follow on to some for.

You mentioned that you've had some feedback from FDA on phase two trial design can you give us any even.

Broad brush strokes thoughts on on the kind of interactions, you're having with the FDA and what direction, you're moving towards for phase two design.

Yes, well I mentioned, we have had feedback from regulatory authorities plural.

Fady Ibraham Malik: So, you know, all of those studies provided us with the data that justify moving forward into humans and ultimately into patients. The preclinical data that were presented a week or two ago elaborate on things we had already been sharing at our R&D day last fall. And what ultimately I think you're going to be most interested in are the phase one data, which now we're announcing you'll be seeing in September. What we can share with you is that we have already seen enough of that data to commit to Phase II. We believe the Phase I data will support and recapitulate things we believe, knowing what we did with the preclinical data, that this compound has properties that we believe will render it beneficial in patients as we move into Phase II. How the drug behaves is very, very important, as we've spoken a few times, and I think we're seeing in the preclinical data and in the Phase I data a consistent story.

FDA and others, but maybe I'll, let study pick up first.

So to sum for phase two to phase two.

Yes, I think Jason the.

What we wanted to get alignment on with.

Regulators is essentially the approach we're taking to the study.

To facilitate its eventual final protocol submission and I think the key things in.

Designing a phase two study, which in this case are going to focus on identifying a pharmacologically active dose and characterizing the dose response relationship than patients with HCM is the.

The starting dose in the study and agreeing that it's a safe dose to begin with as well as the titration schedule and how we take trades in drug in those patients.

So the study design really focused on than kind of the mechanics of how to conduct the study and in general.

Joseph Pantginis: Excellent. Thanks very much for the answers, Paul. Thank you.

Overall.

Outline of how it would be done.

Operator: Thank you.

Jason Nicholas Butler: And your next question comes from Jason Butler from JMP Securities. Hi Jason. Hi Robert, thanks for taking the questions.

And I think the those are very successful interactions a generally agreed with us and we have a clear road to a final protocol.

We are planning in phase two to elaborate on this pharmacology in ways that.

Robert I. Blum: The Bulletproof Executive, 2013

Unknown Speaker: Unknown Speaker You mentioned that you've had some feedback from FDA on the design of the Phase 2 trial. Can you give us any even, you know, broad brushstroke thoughts on the kind of interactions you're having with FDA and what

We'll hopefully elucidate.

The the why behind some of the properties, we've been referring to with CK, two selling for and why it matters and we believe that we've got affirmation of that in the way in which that.

Fady Ibraham Malik: direction you're moving towards for a phase two design. Yeah, I'll mention we've had feedback from regulatory authorities, plural, FDA, and others, but maybe I'll let Fady pick up first. 274?

We've been receiving feedback from regulatory authorities.

Great helpful. And then I think another one for fatty just on the Meteor trial can you just remind us of the patient population here versus galactic and what your assumptions are for a treatment effect, both in terms of drug and and the control arm. Thanks.

Fady Ibraham Malik: Phase 2? He's in phase 2. Yeah, I think Jason, what we wanted to get alignment on with regulators is essentially the approach we're taking to the study to facilitate its eventual final protocol submission. And I think the key things in designing a Phase II study, which in this case is going to focus on identifying a pharmacologically active dose and characterizing the dose-response relationship in patients with HCM, So the study design really focused on the kind of the mechanic And, you know, I think those were very successful interactions. They generally agreed with us, and we have a clear road to a final protocol.

Yes, I mean, the patient population is.

A little different from galactic, but not much and galactic we required patients to have been hospitalized. They all have low ejection fractions injection fraction is less than 35%, but in galactic, we're interested in cardiac events being hospitalized or cardiovascular death, so enrolled a high risk patient population.

And the acquired Hospitalizations and also high end teed pro BNP as entry into Galactic immediate work. We're interested in patients that have exercise intolerance, and we don't want them to enter the hospital during the conduct of the study that would be pretty disruptive to a study thats only 20 weeks long and so those patients again have low ejection fraction, but we don't require them to have been hospitalized specs, we exclude recent hospitalization and we also.

Fady Ibraham Malik: You know, we are planning in phase two to elaborate on this pharmacology in ways that will hopefully elucidate the why behind some of the properties we've been referring to with CK274 and why they matter. And we believe that we've got confirmation of that in the way in which we've been receiving feedback from regulatory authorities. Great, helpful. And then I think another one for Fady, just on the meteoric trial, can you just remind us of the patient population here versus galactic?

Focused on demonstrating that they have.

Reduced exercise capacity compared to age matched controls.

Fady Ibraham Malik: For more information, please visit www.fema.gov Yeah, I mean, the patient population is a little different from GALACTIC, but not by much. In GALACTIC, we required patients to have been hospitalized. They all have low ejection fractions, ejection fractions less than 35%.

So these are I would think of them as more stable heart failure patients who have demonstrated.

Exercise intolerance.

Great.

Very helpful. Thanks for taking the questions.

Thank you Jason.

Your next question comes from the line of Chad Messer from Needham and company.

Fady Ibraham Malik: But in GALACTIC, we're interested in cardiac events, being hospitalized, or cardiovascular death. So we enrolled a high-risk patient population and required hospitalizations and also high NT-proBNP as entry into Galactic. In Meteoric, we're interested in patients that have exercise intolerance, and we don't want them to go to the hospital during the conduct of the study. That would be pretty disruptive to a study that's only 20 weeks long. And so those patients, again, have low ejection fractions, but we don't require them to have been hospitalized. We exclude recent hospitalization, and we also focus on demonstrating that they have... reduced exercise capacity compared to age-matched controls. So these are, I would think of them as, more stable heart failure patients who have demonstrated exercise intolerance.

Good afternoon chess.

Good afternoon, Thanks for taking my question.

So for for CK two seven for you we think we have.

Next generation drug with with with some better PK properties for.

With these these patients.

But as you're starting phase two here not just thinking about that sort of phase three.

Are there things that were done for the mob extensive development program that you think you can improve upon with your clinical development program to accentuate that where does it make more sense to try to go down the path. They went and get the best apples to apples comparison and you know just kind of show you are better.

I'll start enough study to respond firstly say.

Fady Ibraham Malik: Great. Very helpful. Thanks for taking the questions. Thank you, Jason.

We're not going to be.

Elaborating on things that were going to be doing.

Operator: The Bulletproof Executive, 2013

In a competitive way, but you know were not.

Comparing the two drugs in a head to head trial.

Chad Messer: Your next question comes from the line of Chad Messer from Needham and Company.

So I don't think theres going to be a clear apples and apples in that regard, but what I can say is that.

Operator: Good afternoon, Chats.

Fady Ibraham Malik: Good afternoon. Thanks for taking my question. So for CK274, we think we have a next generation drug with some better PK properties for these patients, but as you're in the starting phase two here, not just thinking about phase two, but sort of phase three. Unknown Speaker Are there things that were done for MavoCamp, the development program, that you think you can improve upon with your clinical development program to accentuate that? Or does it make more sense to kind of go down the path they went and get the best apples to apples comparison and, you know, just kind of show that you're better?

With regard to CK 274.

We expect that the way in which.

Will develop this drug candidate.

We will be able to elaborate on what may be unique features of this compound that enable it.

To be a dose to differently and also.

How that can translate into.

Clinical outcomes and benefit so.

The phase two study will be.

Elaborated when we begin dosing, but our expectation is so things we will do our similar things that we'll be doing that will be different.

Yes.

I am not looking to add that just are yeah, I think as Robert said I think the.

The way that we develop this drug will inform how it's used obviously, we'll look forward to seeing how the mechanism of action performances.

Fady Ibraham Malik: I'll start and ask Fady to respond. I'll firstly say, We're not going to be elaborating on things that we're going to be doing in a competitive way, but you know we're not comparing the two drugs in a head-to-head trial, so I don't think there's going to be a clear apples and apples in that regard, but what I can say is that with regard to CK274, We expect that the way in which we'll develop this drug candidate will be able to elaborate on what may be unique features of this compound that enable it to be dosed differently and also how that can translate into clinical outcomes and benefits. The phase two study will be elaborated when we begin dosing, but our expectation is there are things we'll do that are similar and things that we'll be doing that will be different.

And myocardial phase three study and that information will also inform how we proceed down the down the road.

But I suspect you will see that both companies are being very thoughtful about how to approach this new pharmacology.

And that this is an evolving landscape.

And it's not just with these compounds but.

Others May emerge and then that will be I think this is all good for patients.

Yes, very helpful and to be clear I wasn't asking whether you're going to do a head to head I was more referring to others.

Theres ways of designing a phase three so it's easier to compare and or harder to compare and.

Fady Ibraham Malik: I may just add that, yeah, I think, as Robert said, I think the way that we develop this drug will inform how it's used. Obviously, we'll look forward to seeing how the mechanism of action performs in, and Myocardia is a Phase 3 study, and that information will also inform how we proceed down the road. But I suspect you'll see that both companies are being very thoughtful about how to approach this new pharmacology, and that this is an evolving landscape. And it's not just with these compounds but also, www.kenhub.com

I appreciate your answer that question. Thank you.

Thank you Chad.

Your next question comes from Charles Duncan from Cantor Fitzgerald.

Hello Charles.

Hi, This is actually Maria on for Charles.

I just had a quick question could you. Please provide a little bit more color granularity regarding the meteoric study I know you said that the enrollment is on track, but maybe just you know how many sites you are targeting and maybe the percent of targeted patients that you think that you'll be able to enroll by year end. Thank you.

Chad Messer: Um, yeah, no, very helpful. And to be clear, I wasn't asking whether you're going to do a head to head comparison; I was more referring to, you know, there are ways of designing phase three so that it's easier to compare or harder to compare. And, you know, I appreciate your answer to that question. Thank you.

Yes, so early to give guidance on where we think will be a year end, even though we are now in August I'm, we're sort of in the early phases of the study startup we've gotten a very good enrollment so far given the given the sites that weve activated there's been a lot of screening going on in and subsequently patients qualifying for the study so.

Operator: Thank you, Chad.

Charles Cliff Duncan: Your next question comes from Charles Duncan from Cantor Fitzgerald.

Operator: Hello Charles.

Maria: Hi, this is actually Maria on behalf of Charles. I just had a quick question.

Fady Ibraham Malik: Could you please provide a little bit more color granularity regarding the meteoric study? I know you said that the enrollment is on track, but maybe just, you know, how many sites you're targeting and maybe the percent of targeted patients that you think that you'll be able to enroll by year end. Thank you.

I'm optimistic that we are moving ahead and and in on track with our goal to complete this study at the time that Galactic wraps up.

Fady Ibraham Malik: Yeah, it's still a little early to give guidance on where we think we'll be at year-end, even as we are now in August. We're sort of in the early phases of the study startup. We've gotten very good enrollment so far, given the sites that we've activated. There's been a lot of screening going on, and subsequently, patients qualifying for the study. I'm optimistic that we are moving ahead and on track with our goal to complete this study at the time that Galactic wraps up. We're targeting in the range of 70 to 90 sites in the U.S. and in Europe and Canada. We'll progress with moving those along, and we'll sort of decide on the final number depending on how enrollment begins to emerge. What you can do is also check on clinicaltrials.gov because we're updating that regularly as we add new sites.

You know, we're we're targeting in the range of 70 to 90 sites in.

The U.S. and ER and in Europe , and in Canada. So.

You know, we'll progress moving goes along and we'll sort of decide on the final number depending on how enrollment begins to.

Emerge.

What's your what's your can do is also be checking on clinical trials dot Gov, because we're updating that regularly as we add new sites.

Perfect. Thank you.

Thank you.

Your next question comes from the line of Ted Tenthoff of Piper Jaffray.

Uh huh.

Thanks, Hi, everybody. Thanks for your public refer to the data tell in Philly.

When it comes to to set a whore lay out sort of the rationale. It's your work with partnering versus picking up swartzberg yourselves. Thanks.

Yeah, that's a very good question and.

Maria: Perfect. Thank you.

Operator: Thank you.

You know this goes hand in hand with watching described visa these strategic planning.

Ted Tintoff: Your next question comes from the line of Ted Tintoff on Piper Jeffrey.

Operator: http://TheBusinessProfessor.com

We have a situation where we currently have four programs in the clinic and potentially two more coming into the clinic.

Ted Tintoff: Thanks. Hi everybody.

Robert I. Blum: Thanks for the update. Looking forward to the data down in Philadelphia. When it comes to 274, please lay out sort of the rationale, if you would, for partnering versus taking it further yourselves. Thanks.

And as we think about prioritization, we want to make sure we're doing right by where there's the most opportunity to make the most meaningful impact on patient care and to maximize shareholder return.

Robert I. Blum: Yeah, it's a very good question. And, you know, this goes hand in hand with what Ching described vis-a-vis strategic planning. We have a situation where we currently have four programs in the clinic and potentially two more coming into the clinic. And as we think about prioritization, we want to make sure we're doing right by where there's the most opportunity to make the most meaningful impact on patient care and maximize shareholder return. There are opportunities with respect to a cardiac myosin inhibitor that are very much within our reach, affordable, and tractable, and therefore, there is not a compelling rationale for partnering as it pertains to those. But there are also ones that go beyond our reach in terms of what we might be able to do ourselves, and as such, there could be value in seeking a partner under the right conditions and terms.

There are opportunities with respect to a cardiac myosin inhibitor.

That are very much within our reach affordable intractable and therefore, there is not a compelling rationale for partnering as it pertains to those but they're also ones that go beyond our reach in terms of what we might be able to do ourselves and as such there could be value in seeking a partner under the right conditions and terms.

And.

As we think about that we'll think about rail dissented, we'll think about only captive we'll think about our entire portfolio and make certain that we're doing right by Oh, those tenants that I mentioned right by patient care and right by maximizing shareholder value.

And that could include partnering especially as that may bring in non dilutive capital at a time, when we're trying to dial up or programs across our portfolio.

So that's something that we're taking very very seriously in line with our commitments is Ching mentioned.

Great. Thank you very much and makes a lot of sense I appreciate the update.

Robert I. Blum: And, you know, as we think about that, we'll think about RelDeceptive, we'll think about Omicamptive, we'll think about our entire portfolio, and make certain that we're doing right by those tenants that I mentioned, right by patient care, and right by maximizing shareholder value. And that could include partnering, especially as that may bring in non-dilutive capital at a time when we're trying to dial up our programs across our portfolio.

Thanks Ted.

Your next question comes from Jeff Hong of Morgan Stanley .

Hi, Jeff.

Thanks for taking the questions Hey, I'm for the Omecamtiv Mecarbil interim analysis on superiority is there likely to be any data announced with the interim analysis or is it more continuous planned versus being stopped early for overwhelming success or futility.

And I think you'll see it handled very similar to the way that the last interim analysis is which is we'll just here, whether we should continue or or or not.

Ted Tintoff: So that's something that we're taking very, very seriously in line with our commitments, as Ching mentioned. Great. Thank you very much. That makes a lot of sense. I appreciate the opportunity. Thanks, Ted.

Okay, great and obviously, if they tell us not to continue there'll be a lot more data that will come out in that scenario, but.

Okay, great. Thanks, and then I just wanted to clarify on so you're in discussions with the Stellus on roll deceptive and your drafting protocols for LLS and scheduling meetings with regulatory agencies.

Operator: Your next question comes from Jeff Hung of Morgan Stanley.

Jeff Hung: Thanks for taking the questions. Hey, for the Omicant and McCarble interim analysis on superiority, is there likely to be any data announced with the interim analysis? Or is it more continuous planned versus being stopped early for overwhelming success or futility?

Is there a scenario where a relative sense of may not be advanced or regardless of the outcome of discussions with the sellers are you expecting to continue forward with rather sensitive and nail that's necessary.

It's a very good question I think there are scenarios by which we'll just dumped it goes forward more quickly or more slowly depending on other priorities of the company in context of our strategic planning and how that ultimately gets funded and whether that's something that we choose to do before we know you know we turned over other cards or afterwards so.

Robert I. Blum: And I think you'll see it's handled very similarly to the way that the Latinum analysis is, which is we'll just hear whether we should continue or not. Okay, great.

Operator: The Bulletproof Executive 2013 Okay, great, thanks. And then I just want to clarify, so you're in discussions with Distellas on REL-Deceptive, and you're drafting protocols for ALS and scheduling meetings with regulatory agencies. Is there a scenario where REL-Deceptive may not be advanced, or regardless of the outcome of discussions with Distellas, are you expecting to continue forward with REL-Deceptive in ALS and SMA?

There are things that we can do to dial up or dial back activities and that's something that we and our board are discussing.

Okay, Great and then just a housekeeping question expenses cropped up again in Twoq. So are you reiterating your prior expense guidance or how should we think about the expense trends for the rest of the year.

Robert I. Blum: It's a very good question. I think there are scenarios by which RelDeceptive goes forward more quickly or more slowly depending on other priorities at the company in the context of our strategic planning and how that ultimately gets funded and whether that's something that we choose to do before we know, you know, we turn over other cards or after. There are things that we can do to dial up or dial back activities, and that's something that we and our board are discussing.

Yes, we are Jeff. This is chip a we're not changing our expense guidance, our net cash burn remains 85 to 90 million player.

Okay. Thank you.

Thank you.

And we have a question from Joe Pantginis from H.C. Wainwright.

Hey, guys. Thanks for taking the follow up with regard to meteoric we did touch upon this in the past but.

[noise] prepared comment about the quality of the site.

Pat I was wondering if you could provide more color around that especially on the potential.

Jeff Hung: Okay, great. And then just a housekeeping question. Expenses crept up again in two queues. So are you reiterating your prior expense guidance, or how should we think about the expense trend for the rest of the year?

Youre I get the view.

You've addressed as much.

Can.

Mm the concept.

Your size.

Ching W. Jaw: Yes, we, Jeff, this is Ching. We're not changing our expense guidance. Our net cash firm remains $85 to $90 million per year.

Beyond placebo effect, yes.

You're breaking up so I'm, sorry can you say.

Good.

Maybe you can just try your question again, because you were coming in and there is this good.

Jeff Hung: Okay, thank you. Thank you.

Not great.

Operator: Thank you.

Joseph Pantginis: And we have a question from Joe Pantginis from H.C. Wainwright. Hey guys, thanks for taking the follow-up. With regard to Meteoric, we did touch upon this in the past, but just based on facts... [inaudible] You've addressed as much... Beyond the Placebo Effect. Yes. You're breaking up, so I'm sorry.

Okay I apologize for that sure would do is I can I'll leave my question and apologize Okay. No problem. Thanks, So sorry about that Joe but by all means please email your question and we'll follow up with you.

And we have no further questions at this time.

Thank you operator, and thank you too.

Operator: Sorry, can you hear me now?

Everybody, who joined did and participated in this call today. These are especially encouraging times given all the updates that we provided with our Q2 earnings release and through this call and we look forward to providing further updates through the third quarter and the remainder of the year.

Joseph Pantginis: Maybe you can just try your question again because you were coming in and out. Is this good?

Joseph Pantginis: Okay. I apologize for that. I'm not sure what to do with this.

Joseph Pantginis: I'll email my question in. I apologize. Okay. No problem. Thanks, Joe. Sorry about that, Joe, but by all means, please email your question in.

We welcome your questions and comments and.

Operator: Sorry about that, Joe, but by all means, please email your question and we'll follow up with you.

We appreciate very much your support operator with that we can now conclude the call.

Ladies and gentlemen that does conclude today's conference call. You may now disconnect. Thank you for your participation.

Operator: And we have no further questions at this time.

Operator: Thank you, Operator, and thank you to everybody who joined in and participated in this call today. These are especially encouraging times given the updates that we provided with our Q2 earnings release and during this call. And we look forward to providing further updates through the third quarter and the remainder of the year. We welcome your questions and comments, and we appreciate very much your support. Operator, with that, we can now conclude the call. Ladies and gentlemen, that does conclude today's conference call. You may now disconnect. Thank you for your participation.

[laughter].

Ladies and gentlemen, this does conclude today's conference call. You may now disconnect. Thank you for your participation.

Operator: ???

Operator: ...

Operator: Ladies and gentlemen, this does conclude today's conference call. You may now disconnect. Thank you for your participation. Ladies and gentlemen, this does conclude today's conference call. You may now disconnect. Thank you for your participation. Thanks for watching!

Ladies and gentlemen, this does conclude today's conference call. You may now disconnect. Thank you for your participation.