MabVax Therapeutics to Present Three Posters at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

On October 26, 2017 MabVax Therapeutics Holdings, Inc. (NASDAQ: MBVX), a clinical-stage oncology drug development company focused on the development of antibody-based products to address unmet medical needs in the treatment of cancer, reported that it will present three posters highlighting both new clinical findings and preclinical research accomplishments at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) being held October 26 – 30, 2017 in Philadelphia, Pennsylvania (Press release, MabVax, OCT 26, 2017, View Source [SID1234521221]).

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Paul Maffuid, Ph.D., Executive Vice President of Research and Development of MabVax, stated, “We look forward to sharing the significant progress we have made through these clinical and preclinical investigations. We will report new clinical data from our ongoing Phase 1 clinical trial and report on our most advanced preclinical program that demonstrates our growing expertise in the development of fully human antibodies targeting carbohydrate antigens expressed on many solid tumor cancers.”

The Company will present the following posters during the meeting:

Presenting Author: Paul Maffuid, Ph.D., Executive Vice President Research and Development, MabVax Therapeutics
Title: Using CA19-9 as a translational biomarker for sLea targeted agents MVT-5873 and MVT-1075 in cancer
Date & Time: Saturday, October 28, 2017 at 12:30 PM
Session: Poster Session A: Biomarkers
Location: Hall E, Pennsylvania Convention Center
Poster No.: 62
Abstract No.: A062

The poster summarizes preclinical development activities including a survey of CA19-9 positive cancers in patient tissue microarrays and patient sera samples treated with the anti-CA19-9 antibody MVT-5873 with potential utility as a translational biomarker.

Presenting Author: Paul Maffuid, Ph.D., Executive Vice President Research and Development, MabVax Therapeutics
Title: Preliminary Phase 1 data comparing HuMab-5B1 (MVT-5873), a monoclonal antibody targeting sLea, as a single agent and in combination with first line nab-paclitaxel and gemcitabine in patients with CA19-9 positive pancreatic cancer
Date & Time: Sunday, October 29, 2017 at 12:30 PM
Session: Late Breaking Poster Session B: Therapeutic Agents: Biological
Location: Hall E, Pennsylvania Convention Center
Poster No.: LB-25
Abstract No.: LB-B25

The poster summarizes interim data from the ongoing Phase 1 trial of MVT-5873 used as a single agent and in combination with a first line therapy in newly diagnosed patients with CA19-9 positive pancreatic cancer.

Presenting Author: G. Jonah Rainey, Ph.D., Executive Director Antibody Research, MabVax Therapeutics
Title: A therapeutic antibody candidate against the broadly expressed Tn and sTn carbohydrate cancer antigens
Date & Time: Sunday, October 29, 2017 at 12:30 PM
Session: Poster Session B: Therapeutic Agents: Biological
Location: Hall E, Pennsylvania Convention Center
Poster No.: 104
Abstract No.: B104

The poster summarizes the discovery, optimization, and target validation for the Company’s fully human antibodies targeting the Thomsen-nouveau (Tn) and the sialyl Tn (sTn) carbohydrate antigens for patients with ovarian and breast cancers.

Innovation Pharmaceuticals Aims to Develop First Drug for Approval in Prevention of Oral Mucositis in Head and Neck Cancer Patients as Phase 2 Clinical Trial of Brilacidin Completes

On October 26, 2017 Innovation Pharmaceuticals Inc. (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to report the completion of the Phase 2 trial (see link NCT02324335) of Brilacidin-OM for the prevention and treatment of Oral Mucositis (OM) in Head and Neck Cancer (HNC) patients receiving chemoradiation therapy (CRT). The final patient in the Phase 2 randomized, placebo-controlled clinical trial completed their post-therapy follow-up examination this week (Press release, Innovation Pharmaceuticals, OCT 26, 2017, View Source [SID1234521220]). The Company has begun the process of closing trial study sites and is now aggregating patient data for top-line analysis, to be reported this quarter.

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The primary objectives of the trial are the evaluation of the efficacy of Brilacidin-OM in reducing the incidence of severe OM (WHO Grade ≥3) compared to placebo during seven weeks of study treatment/CRT, and assessment of the safety and tolerability of this novel OM oral rinse therapy. A secondary objective includes evaluating the efficacy of Brilacidin in reducing the duration of severe OM.

The completion of the trial represents an important milestone, positioning the Company to address a significant unmet medical need. There are currently no FDA-approved drugs for preventing OM in patients with Head and Neck Cancer receiving chemoradiation. This painful condition affects upwards of 90 percent of patients in this population as well as a large number of patients receiving CRT for other cancers.

The Company believes that a successful Phase 2 trial would be a major breakthrough. Fast Track designation by the Food and Drug Administration (FDA) for Brilacidin-OM has already been awarded. In addition, the Company plans to apply for FDA Breakthrough Therapy Designation should top-line end of study results reflect similar efficacy (and safety) to that observed at interim, in which patients treated with Brilacidin-OM experienced a markedly reduced rate of severe OM compared to those on placebo.

“By 2030, the global annual incidence of Head and Neck Cancer is expected to exceed 1 million cases,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “It’s a horribly debilitating condition that causes tremendous suffering and leads to corresponding delays in clinical care, adding to costs and complications, for those who experience it. We look forward to compiling and releasing the topline Brilacidin-OM data, toward advancing it into a potential pivotal Phase 3 clinical trial—a final step toward Brilacidin-OM possibly emerging as the world’s first-ever approved preventative treatment for Oral Mucositis in this population.”

West Announces Third-Quarter 2017 Results

On October 26, 2017 West Pharmaceutical Services, Inc. (NYSE: WST) reported its financial results for the third quarter of 2017, updated financial guidance for the full-year 2017, introduced sales growth outlook for full-year 2018 and reaffirmed long-term financial targets (Press release, West Pharmaceutical Services, OCT 26, 2017, View Source [SID1234521219]).

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Third-Quarter 2017 Highlights

Reported net sales of $398.2 million grew 5.7% over the prior-year quarter. Net sales at constant currency (organic) grew by 3.7%.
Third-quarter 2017 reported-diluted EPS was $0.67, compared to reported-diluted EPS of $0.50 and adjusted-diluted EPS of $0.53, both in the prior-year quarter. There were no adjustments made in the third-quarter 2017.
Hurricanes in Puerto Rico had a negative impact on third-quarter 2017 sales of approximately $2 million. At current low levels of operations at both our Puerto Rican contract manufacturing facility and Biologics customers located in the area, we estimate fourth-quarter 2017 sales to be adversely impacted by approximately $5 million.
Raising full-year 2017 sales and adjusted-diluted EPS guidance. Full-year 2017 sales guidance is expected to be in a range between $1.595 billion and $1.605 billion, compared to the prior guidance range between $1.585 billion and $1.600 billion. This includes hurricane-related impacts in Puerto Rico. Full-year 2017 adjusted-diluted EPS guidance is expected to be in a range between $2.74 and $2.79, compared to the prior guidance range between $2.66 and $2.73. This includes an estimated fourth-quarter 2017 adjusted-diluted EPS negative impact of $0.03 from hurricane-related issues in Puerto Rico. Both current and prior guidance ranges include the favorable impact from tax-related benefits associated with share-based payment transactions that have been recognized during the first nine months of 2017.
Providing long-term financial objectives consistent with prior plans.
“Adjusted-diluted EPS” and “net sales at constant currency” are Non-GAAP measurements. See discussion under the heading “Non-GAAP Financial Measures” in this release.

Executive Commentary

“Our third-quarter performance was in line with our expectations,” said Eric M. Green, President and Chief Executive Officer. “We are on track to finish 2017 with strong organic sales growth led by high-value product growth in the Biologics and Generics market units.

“Looking to the future, we continue to see positive fundamentals in the markets we serve. We see unit volume growth from existing injectable drugs, future new drug approvals, and new generics and biosimilars that are entering the market. There is continued growth potential for high-value product (HVP) adoption in all our market units – Pharma, Generics and Biologics – as customers strive for higher quality and increasingly adopt zero-defect strategic imperatives. We have successfully focused our Contract-Manufactured Product segment on serving injectable medicines and diagnostic customers, and our consumer goods business continues to become a smaller part of that segment’s sales.”

Mr. Green concluded, “I am proud of our employees and their dedication to safety, quality and innovation. All of us at West are aware of the critical importance that our products play in the integrated containment and delivery of injectable medicines. I am especially proud of their response during this severe hurricane season. With a strong global team, focused on helping our customers, we are well-positioned for the future.”

Third-Quarter 2017 Financial Results (comparisons to prior-year period)

Reported net sales were $398.2 million, compared to $376.7 million. Reported net sales growth was 5.7%. On a constant-currency basis, organic sales growth was 3.7%.

Proprietary Products segment reported net sales were $308.9 million, compared to $298.1 million. Reported net sales growth was 3.6%. Organic sales growth was 1.5%, led by low-single digit growth in the Biologics and Generics market units. Biologics sales growth was lower than anticipated due to customers in Puerto Rico unable to receive shipments. Excluding this impact, Biologics organic sales growth would have been in the mid-single digit range. Generics market unit organic sales growth was positive after three consecutive quarters of declines. Pharma market unit sales declined low-single digits after a strong first-half 2017 performance.

Committed orders in the Proprietary Products segment at September 30, 2017, were $375 million, a decrease of 6% at constant currency compared to September 30, 2016.

Contract-Manufactured Products segment reported net sales were $89.3 million, compared to $79.0 million. Reported net sales growth was 13.1%, and organic sales growth was 11.5%.

Gross profit margin was 31.4%, a decrease of 70 basis points. Proprietary Products segment gross profit margin was 35.8%, a decrease of 60 basis points due to lower sales growth of high-value products, increased labor and overhead costs, partially offset by production efficiencies. Contract-Manufactured Products segment gross profit margin was 16.3%, an increase of 30 basis points due to a favorable mix of products sold and higher sales volume, partially offset by increased labor and overhead costs.

Third-quarter 2017 reported operating profit was $63.9 million, which represented an operating profit margin of 16.1%, an increase of 250 basis points from the prior-year quarter. The major driver of margin expansion was Proprietary Products other (income) expense, as the Company recognized $9.1 million of income for reimbursed costs associated with a technology that was subsequently licensed to a third party.

Income tax expense in the quarter was $14.0 million, which represented an effective tax rate of 22.3%. The effective tax rate reflects the impact of a tax benefit of $4.8 million associated with tax benefits from the adoption of guidance issued by the FASB regarding share-based payment transactions. Excluding the impact, the effective tax rate would have been approximately 30%.

Full-Year 2017 Financial Guidance

The Company is maintaining its full-year 2017 constant-currency (organic) sales growth guidance of approximately 6%.

West’s expected full-year 2017 net sales, margin and EPS guidance are as follows:

(in millions, except EPS)
2017 Updated
Guidance
Prior Guidance
Consolidated net sales
$1,595 to $1,605
$1,585 to $1,600
Consolidated gross profit margin (% of net sales)
32.6% to 32.8%
32.7% to 33.3%
Proprietary Products net sales
$1,250 to $1,255
$1,240 to $1,250
Contract-Manufactured Products net sales
$345 to $350
$345 to $350
Full-Year adjusted-diluted EPS*
$2.74 to $2.79
$2.66 to $2.73
*Includes the reported-diluted EPS impact of $0.40 for the first nine months of 2017 tax-benefit associated with the previously-discussed adoption of FASB-issued guidance. Also includes an estimated adverse impact due to severe-weather issues in Puerto Rico of approximately $5 million of net sales (and impact to consolidated gross margins) and $0.03 of adjusted-diluted EPS.
The principal currency assumption used in preparing these estimates is the translation of the euro at $1.18 for the remainder of 2017, compared to a prior assumption of $1.14 per euro.

Excluding the impact from tax benefits associated with the previously-discussed adoption of FASB-issued guidance, the Company expects that its annual effective tax rate will be approximately 30%. The Company does not plan on forecasting future benefits as they could vary quarter to quarter with the time and size of stock option exercises. Instead, the Company will include the impacts with each reported period. As a point of reference, the Company would have had $0.8 million of net income benefit in the third quarter of 2016 and would have had $18 million for the full-year 2016, resulting in an EPS benefit of $0.01 in the third-quarter 2016 and $0.24 for the full-year 2016.

The Company estimates its 2017 capital spending to be approximately $150 million.

2018 Sales Outlook and Long-Term Financial Construct

The Company expects 2018 constant-currency, organic sales growth to be in the range of 6% to 8% as a result of market volume growth and continued HVP conversions. Biologics and Generics market units are expected to return to more typical levels, with growth moderation in Contract-Manufactured Products following a strong 2017 and continued portfolio management of the consumer goods business.

The Company’s long-term financial construct remains consistent with prior plans, with 6% to 8% annual constant-currency, organic sales growth. We expect incremental sales growth from proprietary delivery systems such as SmartDose and Crystal Zenith, as their relative sales base increases over time. Favorable product mix shift, coupled with operational excellence and optimization programs, are expected to expand operating profit margins by approximately 100 basis points per year. Annual capital spending is expected to remain in a range of between $150 million and $175 million.

The Company updates and shares its high-level, long-term objectives in order to help investors, employees and other stakeholders better understand the strategic value of current and planned capital and research and development investments. As such, the revenue and profitability goals are not intended to predict or estimate actual results in any future period, but to indicate management’s view of what it believes to be achievable in that time frame.

Third-Quarter Conference Call

The Company will host a conference call to discuss the results and business expectations at 9:00 a.m. Eastern Time today. To participate on the call please dial 877-930-8295 (U.S.) or 253-336-8738 (International). The conference ID is 94093362.

A live broadcast of the conference call will be available at the Company’s website, www.westpharma.com, in the “Investors” section. Management will refer to a slide presentation during the call, which will be made available on the day of the call. To view the presentation, select “Presentations” in the “Investors” section of the Company’s website.

An online archive of the broadcast will be available at the website three hours after the live call and will be available through Thursday, November 2, 2017, by dialing 855-859-2056 (U.S.) or 404-537-3406 (International) and entering conference ID 94093362.

Forward-Looking Statements

Certain forward-looking statements are included in this release. They use such words as “expected,” “reflects,” “continue,” “raising,” “see,” “increase,” “plan,” “will,” “estimated,” “remain,” “may,” “believes,” “expect,” “include,” “estimate,” and other similar terminology. These statements reflect management’s current expectations regarding future events and operating performance and speak only as of the date of this release. There is no certainty that actual results will be achieved in-line with current expectations. These forward-looking statements involve a number of risks and uncertainties. The following are some of the factors that could cause our actual results to differ materially from those expressed in or underlying our forward-looking statements: customers’ changing inventory requirements and manufacturing plans; customer decisions to move forward with our new products and product categories; average profitability, or mix, of the products we sell; dependence on third-party suppliers and partners; interruptions or weaknesses in our supply chain; increased raw material costs; fluctuations in currency exchange; and the ability to meet development milestones with key customers. This list of important factors is not all inclusive. For a description of certain additional factors that could cause the Company’s future results to differ from those expressed in any such forward-looking statements, see Item 1A, entitled “Risk Factors,” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016.

Except as required by law or regulation, we undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise.

Non-GAAP Financial Measures

This press release and the preceding discussion of the Company’s results, financial guidance, and the accompanying financial tables use the following financial measures that have not been calculated in accordance with U.S. generally accepted accounting principles (GAAP), and therefore are referred to as Non-GAAP financial measures:

Net sales at constant currency (organic sales growth)
Adjusted operating profit
Adjusted operating profit margin
Adjusted income tax expense
Adjusted net income
Adjusted diluted EPS
Net debt
Total invested capital
Net debt-to-total invested capital
The Company believes that these Non-GAAP measures of financial results provide useful information to management and investors regarding business trends, results of operations, and the Company’s overall performance and financial position. The Company’s executive management team uses these financial measures to evaluate the performance of the Company in terms of profitability and efficiency, to compare operating results to prior periods, to evaluate changes in the operating results of each segment, and to measure and allocate financial resources to its segments. The Company believes that the use of these Non-GAAP financial measures provides an additional tool for investors to use in evaluating ongoing operating results and trends in comparing its financial measures with other companies.

The Company’s executive management does not consider such Non-GAAP measures in isolation or as an alternative to such measures determined in accordance with GAAP. The principal limitation of these financial measures is that they exclude significant expenses and income that are required by GAAP to be recorded. In addition, they are subject to inherent limitations as they reflect the exercise of judgment by management about which items are excluded. In order to compensate for these limitations, Non-GAAP financial measures are presented in connection with GAAP results. The Company urges investors and potential investors to review the reconciliations of its Non-GAAP financial measures to the comparable GAAP financial measures, and not to rely on any single financial measure to evaluate the Company’s business.

Net sales at constant currency translates the current-period reported sales of subsidiaries whose functional currency is other than the U.S. dollar at the applicable foreign exchange rates in effect during the comparable prior-year period. In calculating adjusted operating profit, adjusted operating profit margin, adjusted income tax expense, adjusted net income and adjusted diluted EPS, the Company excludes the impact of items that are not considered representative of ongoing operations. Such items may include restructuring and related costs, certain asset impairments, other specifically-identified gains or losses, and discrete income tax items. A reconciliation of these adjusted Non-GAAP measures to the comparable GAAP financial measures is included in the accompanying tables.

The following is a description of the items excluded from adjusted operating profit, adjusted income tax expense, adjusted net income, and adjusted diluted EPS for the three and nine months presented in the accompanying tables:

Venezuela deconsolidation – During the nine months ended September 30, 2017, as a result of the continued deterioration of conditions in Venezuela, as well as its continued reduced access to U.S. Dollar settlement controlled by the Venezuelan government, the Company recorded a charge of $11.1 million related to the deconsolidation of its Venezuelan subsidiary, following its determination that it no longer met the GAAP criteria for control of that subsidiary. As of April 1, 2017, the Company’s consolidated financial statements exclude the results of its Venezuelan subsidiary.

Restructuring and related charges – During the three months ended September 30, 2016, the Company recorded $2.3 million in restructuring and related charges, consisting of $1.4 million for severance charges and $0.9 million for a non-cash asset write-down associated with the discontinued use of certain equipment. During the nine months ended September 30, 2016, the Company incurred $23.7 million in restructuring and related charges, consisting of $7.8 million for severance charges and $15.9 million for non-cash asset write-downs associated with the discontinued use of certain trademarks and certain equipment.

Venezuela currency devaluation – During the nine months ended September 30, 2016, the Company recorded a charge of $2.7 million related to the devaluation of the Venezuelan Bolivar from the previously-prevailing official exchange rate of 6.3 Bolivars to USD to 10.0 Bolivars to USD.

Discrete tax item – During the three and nine months ended September 30, 2016, the Company recorded a discrete tax charge of $0.3 million resulting from the impact of a change in the enacted tax rate in the United Kingdom on its previously-recorded deferred tax asset balances.

Transgene: First Patient Treated in a Phase 1/2a Trial (Oncovirac) of Novel Oncolytic Virus TG6002 in Recurrent Glioblastoma

On October 26, 2017 Transgene (Paris:TNG) (Euronext Paris: TNG), a biotech company that designs and develops viral-based immunotherapies, reported that the first patient with recurrent glioblastoma has been treated at La Pitié-Salpêtrière hospital, Greater Paris University Hospitals, AP-HP (Paris), in the first-in-human clinical trial (Oncovirac trial) of TG6002, a novel oncolytic virus (Press release, Transgene, OCT 26, 2017, View Source [SID1234521218]). TG6002 represents the next generation of oncolytic virus (OV), which is administered intravenously and has multiple functions. It has been engineered to combine oncolysis (the breakdown of cancer cells) with the local production of 5-FU chemotherapy agent in the tumor. It is also expected to induce an immune response following the antigen spreading that is caused by the cancer cells’ breakdown.

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TG6002: a novel oncolytic virus allowing the targeted production of chemotherapy in the tumor

TG6002 is a next generation oncolytic immunotherapy, which has a double mechanism of action. It has been designed by Transgene to:

1. induce the breakdown of cancer cells (oncolysis) by tumor-selective viral replication. In preclinical experiments, TG6002 was able to induce response in the primary tumor and an immune-mediated regression of distant metastases (immunogenic cell death);

2. allow the local production of chemotherapy (5-FU), a widely used cancer chemotherapy, in the tumor. TG6002 expresses the proprietary Fcu1 gene in the cancer cells it has infected, leading to the local conversion of the 5-FC into 5-FU.

First-in-human trial to deliver first readouts in H2 2018

Oncovirac is an open-label Phase 1/2a trial evaluating the safety and tolerability of multiple-ascending doses of TG6002 administered intravenously in combination with oral 5-FC, a non-cytotoxic pro-drug, flucytosine, that can be converted in 5-FU. The anti-tumor activity of this novel oncolytic virus will also be monitored. The study will enroll patients suffering from recurrent glioblastoma, who have failed standard of care treatment.

Dr. Ahmed Idbaih, M.D., PhD, neuro-oncologist at La Pitié-Salpêtrière Hospital (Paris, France), is the principal investigator of the study. He is involved in several clinical trials dedicated to primary brain tumor patients. He also coordinates “GlioTex”, a research group focused on glioblastoma and experimental therapeutics at ICM (The Institut du Cerveau et de la Moelle épinière – Brain & Spine Institute). AP-HP Paris Greater Hospitals, is the sponsor of Oncovirac, a trial also supported by INCa (French National Cancer Institute). More information on the trial is available on clinicaltrials.gov (NCT03294486). The first readouts of the study are expected in the second half of 2018.

Maud Brandely, M.D., PhD, Chief Medical Officer of Transgene, added: “TG6002 is a very promising new generation of oncolytic virus, which has the potential to be administered intravenously. Based on our compelling preclinical data, we have established that its replication induces immunogenic cell lysis and the local production of chemotherapy. We are excited to see this novel immunotherapy with multiple modes of action enter the clinic and look forward to obtaining results that will allow further development of TG6002 in several solid tumors indications.”

Dr. Ahmed Idbaih, M.D., PhD, neuro-oncologist at La Pitié-Salpêtrière hospital, AP-HP, and principal investigator of the trial, added: “Current treatments of recurrent glioblastoma are insufficient. By combining the immunogenic lysis of cancer cells with the targeted production of chemotherapy in the tumor, TG6002 has the potential to show anti-tumor efficacy and to avoid systemic side effects of chemotherapy. We are very pleased to be conducting this first in human clinical trial evaluating this novel immunotherapy that we believe could improve the overall survival of recurrent glioblastoma patients while preserving their quality of life.”

About TG6002
TG6002 is a next generation oncolytic immunotherapy. It has been designed to induce the breakdown of cancer cells (oncolysis) and allow the local production of chemotherapy (5-FU) in the tumor. TG6002 is a modified Vaccinia virus, with double gene deletion (TK-RR-), and expressing the proprietary Fcu1 gene in the cancer cells it has infected, leading to the local conversion of the non-cytotoxic pro-drug, flucytosine (5-FC), into 5-FU, a widely used cancer chemotherapy. The oncolytic virus TG6002 has shown efficacy and good safety profile in several preclinical models of glioblastoma in vitro (i.e. cell line) and in vivo (i.e. xenografts in Swiss/Nude mice). Transgene believes that TG6002 may represent a new therapeutic option in recurrent glioblastoma patients. TG6002 could also be investigated in other solid tumors.

About Glioblastoma
Glioblastoma is the most common and the most aggressive primary brain cancer in adults. Approximately 70,000 new cases are diagnosed each year in Europe 28 and in the USA (Globocan 2012). Despite very intensive treatments (i.e. maximal safe surgery, radiotherapy, and several lines of cytotoxic chemotherapy), inducing significant adverse events, the prognosis of glioblastoma patients remains poor. More efficient and less toxic therapies are urgently needed to improve survival and quality of life of glioblastoma patients.

Cytokinetics, Inc. Reports Third Quarter 2017 Financial Results

On October 26, 2017 Cytokinetics, Incorporated (Nasdaq:CYTK) reported total revenues for the third quarter of 2017 were $6.2 million, compared to $59.0 million, during the same period in 2016. Net loss for the third quarter was $32.4 million, or $0.60 per basic and diluted share, respectively, compared to net income for the same period in 2016 of $33.4 million, or $0.84 and $0.77 per basic and diluted share, respectively (Press release, Cytokinetics, OCT 26, 2017, View Source [SID1234521210]). As of September 30, 2017, cash, cash equivalents and investments totaled $308.2 million.

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“We are proud of the key milestones we recently achieved in preparation for the planned release of results from VITALITY-ALS, and potential regulatory filings and commercialization of tirasemtiv in North America and Europe,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “In the third quarter, we also advanced CK-2127107 into two additional mid-stage clinical trials, one in patients with ALS and another in elderly subjects with limited mobility; we look forward to data from four clinical trials in this program in 2018. Finally, we are pleased that patient enrollment in GALACTIC-HF continues on target and commenced in Japan triggering a $10 million milestone payment to Cytokinetics.”

Recent Highlights and Upcoming Milestones

Skeletal Muscle Program

tirasemtiv (fast skeletal muscle troponin activator)

Completed dosing of patients in VITALITY-ALS (Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices after Treatment for a Year in ALS), our Phase 3 clinical trial of tirasemtiv in patients with ALS.

Continued enrollment in VIGOR-ALS (Ventilatory Investigations in Global Open-Label Research in ALS), an open-label clinical trial designed to assess the long-term safety and tolerability of tirasemtiv in patients with ALS who have completed participation in VITALITY-ALS.

Conducted clinical, regulatory, non-clinical and other activities intended to support potential regulatory filings and registration of tirasemtiv in North America and Europe.

Conducted manufacturing, logistical planning, market research, market access and other commercial readiness activities intended to support potential registration and commercialization of tirasemtiv in North America and Europe.

Proceeding to collection of final data from VITALITY-ALS and clinical trial database lock in Q4 2017. We plan to conduct analyses of data from VITALITY-ALS and present results from this clinical trial on December 8, 2017 at the 28th International Symposium on ALS/MND in Boston.

Expect to continue to enroll patients who complete VITALITY-ALS into VIGOR-ALS throughout 2017.

CK-2127107 (next-generation fast skeletal muscle troponin activator)

Announced the start of a Phase 1b, double-blind, randomized, placebo-controlled, multiple dose, two-period crossover study to assess the effect of CK-2127107 on measures of physical function in elderly adults with limited mobility. This study is being conducted by Astellas, in collaboration with Cytokinetics.
Announced the start of FORTITUDE-ALS (Functional Outcomes in a Randomized Trial of Investigational Treatment with CK-2127107 to Understand Decline in Endpoints – in ALS). This Phase 2 clinical trial is designed to assess the change from baseline in the percent predicted slow vital capacity (SVC) and other measures of skeletal muscle function after 12 weeks of treatment with CK-2127107 in patients with ALS. This trial is being conducted by Cytokinetics, in collaboration with Astellas.
“Reasons for Screen Failures and Baseline Characteristics of Randomized Patients from the First Cohort of the Phase 2 Clinical Trial of CK-2127107 in Patients with SMA,” presented by Stacy Rudnicki, M.D., Director, Clinical Research, Cytokinetics, at the Cure SMA 2017 Annual SMA Conference in Orlando, FL.
Expect to complete enrollment of Cohort 2 of the Phase 2 clinical trial of CK-2127107 in patients with SMA in 2017.
Expect data from the Phase 2 clinical trial of CK-2127107 in patients with SMA in Q1 2018.
Expect Astellas to continue enrollment in a Phase 2 clinical trial of CK-2127107 in patients with COPD in 2017.
Expect Astellas to continue enrollment in a Phase 1b clinical trial of CK-2127107 in adults with limited mobility in 2017.

Expect to continue enrollment in FORTITUDE-ALS, a Phase 2 clinical trial of CK-2127107 in patients with ALS in 2017.
Cardiac Muscle Program

omecamtiv mecarbil (cardiac muscle myosin activator)

Announced that the Phase 2 clinical trial of omecamtiv mecarbil in Japanese patients with heart failure met its pharmacokinetic primary endpoint and demonstrated statistically significant improvements in systolic ejection time (SET), a secondary endpoint.

Announced that the first patient has been dosed in Japan in GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), the Phase 3 cardiovascular outcomes clinical trial of omecamtiv mecarbil which is being conducted by Amgen, in collaboration with Cytokinetics. Coincident with patient dosing in Japan, Cytokinetics earned a $10 million milestone payment from Amgen.

Announced that additional results from COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure), a Phase 2 trial evaluating omecamtiv mecarbil in patients with chronic heart failure, were presented by John Teerlink, M.D., Professor of Clinical Medicine at the University of California San Francisco and Director of Heart Failure at the San Francisco Veterans Affairs Medical Centers in a Rapid Fire Abstracts Presentation at the 21st Annual Heart Failure Society of America Scientific Meeting in Dallas, TX. The results suggest that omecamtiv mecarbil may produce similar results with regard to cardiac function, heart rate, biomarkers and adverse events in patients with ischemic and non-ischemic heart failure due to left ventricular systolic dysfunction.

Continued to enroll patients in GALACTIC-HF, the Phase 3 cardiovascular outcomes clinical trial of omecamtiv mecarbil, conducted by Amgen, in collaboration with Cytokinetics.

Expect continued enrollment of patients with chronic heart failure in GALACTIC-HF throughout 2017.
Pre-Clinical Research

Continued research activities under our joint research program with Amgen directed to the discovery of next-generation cardiac muscle activators and under our joint research program with Astellas directed to the discovery of next-generation skeletal muscle activators. In addition, company scientists continued independent research activities directed to our other muscle biology programs.
Expect to nominate at least 2 compounds from ongoing Research programs (partnered and unpartnered) as potential drug candidates by the end of 2017.
Financials

Revenues for the three and nine months ended September 30, 2017 were $6.2 million and $13.4 million, respectively, compared to $59.0 million and $73.3 million for the corresponding periods in 2016. Revenues for the first nine months of 2017 included the $10 million milestone payment from Amgen as well as $8.8 million of research and development revenues and $6.7 million of license revenues from our collaboration with Astellas and $1.3 million of research and development revenues from our collaboration with Amgen. Revenues for the first nine months of 2017 were offset by $13.8 million (out of the total of $40 million) for payments to Amgen related to our option to co-fund the Phase 3 development program of omecamtiv mecarbil in exchange for an increased royalty upon potential commercialization. Revenues in 2016 were primarily due to license revenue from the September 2016 expansion of our collaboration with Astellas. Astellas paid us $65 million in connection with the expanded collaboration.

Total research and development expenses for the three and nine months ended September 30, 2017 increased to $24.9 million and $64.0 million, respectively, from $17.9 million and $41.1 million for the same periods in 2016, primarily due to increased clinical activity, including activity for VITALITY-ALS and other activities intended to support potential regulatory filings and registration of tirasemtiv in North America and Europe, increased CK-2127107 clinical trials activity, as well as increased personnel.

General and administrative expenses for the three and nine months ended September 30, 2017 increased to $9.7 million and $26.2 million from $7.2 million and $21.1 million for the same periods in 2016, primarily due to increased personnel, non-cash stock compensation expense and commercial readiness activities.

Financial Guidance

The Company also announced updated financial guidance for 2017. The Company anticipates cash research and development expenses will be in the range of $103 to $107 million, cash revenue will be in the range of $16 to $18 million, and cash general and administrative expenses will remain in the range of $30 million to $32 million.

Conference Call and Webcast Information

Members of Cytokinetics’ senior management team will review the company’s third quarter results via a webcast and conference call today at 4:30 PM Eastern Time. The webcast can be accessed through the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by dialing either (866) 999-CYTK (2985) (United States and Canada) or (706) 679-3078 (international) and typing in the passcode 46689063.

An archived replay of the webcast will be available via Cytokinetics’ website until November 2, 2017. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (international) and typing in the passcode 46689063 from October 26, 2017 at 7:30 PM Eastern Time until November 2, 2017.