On August 8, 2019 Nevro Corp. (NYSE: NVRO), a global medical device company that is providing innovative, evidence-based solutions for the treatment of chronic pain, reported financial results for the second quarter ended June 30, 2019 (Press release, Nevro, AUG 8, 2019, View Source [SID1234538467]).

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Revenue for the second quarter of 2019 was $93.6 million, a 3% decrease compared to $96.1 million during the prior year period. U.S. revenue for the second quarter of 2019 was $78.1 million, a 2% decrease compared to $79.9 million in the prior year period. The year-over-year decrease in U.S. revenue was primarily driven by the impact of customer destocking associated with the Company’s previously announced decision to alter its practice regarding certain high-volume product orders. International revenue was $15.5 million compared to $16.2 million in the prior year period. This represents a 4% decrease on an as-reported basis and a 2% increase on a constant currency basis.

"Our second quarter 2019 financial results demonstrate sequential improvement across the board, as well as some encouraging early signs of progress in our commercial execution, including patient treatment activity with our customers. In the U.S., we saw a year-over-year increase in patient trial procedures of 15%, while permanent implant procedures grew 10% over the prior year period," said D. Keith Grossman, Chairman, CEO and President. "I remain confident that as we continue to refine our commercial strategies and execution, prepare for our upcoming new product launches and drive interest in HF10 therapy, we will be well-positioned to enter our next phase of growth as we move into late 2019 and enter 2020."

Gross profit for the second quarter of 2019 was $63.9 million, a 6% decrease compared to $67.9 million in the prior year period. Gross margin was 68% in the second quarter of 2019 compared to 71% in the prior year period.

Operating expenses for the second quarter of 2019 were $90.5 million, a 19% increase compared to $76.1 million in the prior year period. The year-over-year increase in operating expenses was primarily driven by U.S. sales and marketing personnel costs, as well as clinical trial-related expenses. Legal expenses associated with patent litigation were $3.9 million for the second quarter of 2019, compared to $5.8 million in the prior year period.

Net loss from operations for the second quarter of 2019 was $26.6 million, compared to $8.2 million in the prior year period.

Cash, cash equivalents and short-term investments totaled $233.9 million as of June 30, 2019. Net cash used during the second quarter of 2019 was $5.7 million and $30.6 million for the six months ended June 30, 2019.

Full Year 2019 Financial Guidance
Nevro currently expects 2019 worldwide revenues to be in the $368 to $374 million range. Gross margin is expected to be in the high 60’s as a percent of revenue.

Webcast and Conference Call Information
Management will host a conference call today beginning at 1:30 p.m. PT / 4:30 p.m. ET. Investors interested in listening to the conference call may do so by dialing (833) 286-5807 in the U.S. or (647) 689-4452 internationally, using Conference ID: 1694716. In addition, a live webcast will be available on the "Investors" section of the company’s website at www.nevro.com, as well as an archived recording.

On August 8, 2019 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported its financial and operational results for the second quarter ended June 30, 2019 (Press release, Autolus, AUG 8, 2019, View Source [SID1234550688]).

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Operational Highlights:

In April, Autolus announced the presentation of initial data from the ongoing Phase 1/2 ALLCAR19 clinical trial of AUTO1 in adult ALL at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 in Atlanta, Georgia. As of the data cutoff date of May 18, 2019, 13 patients were leukapheresed, and products for 12 patients were manufactured, including 7 with Autolus’ semi-automated, fully enclosed manufacturing process. Using the Lee criteria, there were no patients with severe cytokine release syndrome (CRS) (≥ Grade 3), and only 2 of 10 patients (20%) with Grade 2 CRS. Tocilizumab was used in 2 of 10 patients (20%). None of the patients were admitted to intensive care due to CRS. One patient developed delayed Grade 3 neurotoxicity following high levels of CAR T expansion, which resolved promptly following administration of steroids. Four patients died while enrolled in the trial, 2 due to progression of the disease and 2 due to sepsis, a common complication in patients with advanced ALL. Nine patients were evaluable for response at 1 month with 8 (88%) achieving a molecular complete response. One patient died of sepsis before the one-month evaluation point. At a median follow-up of 5 months (range 0.62-10.6 months), 6 of 10 patients were alive and continue to be in molecular remission with continued evidence of ongoing B cell aplasia and CAR T persistence.
In April, Autolus completed an underwritten public offering of 4,830,000 American Depositary Shares ("ADSs") representing 4,830,000 ordinary shares, at a public offering price of $24.00 per ADS, which includes an additional 630,000 ADSs issued upon the exercise in full of the underwriters’ option to purchase additional ADSs. Aggregate net proceeds to Autolus, after underwriting discounts but before estimated offering expenses, were $108.8 million.
Pipeline Updates and Anticipated Milestones:

Initiation of a Phase 2 registration trial of AUTO1 in adult ALL in the fourth quarter of 2019 (pending regulatory feedback). Updated Phase 1 data from the ALLCAR19 clinical trial is expected at ASH (Free ASH Whitepaper) 2019.

Decision on Phase 2 initiation for the Alexander study of AUTO3 in DLBCL is expected for mid-2020. Interim Phase 1 data is expected at ASH (Free ASH Whitepaper) 2019.

Development of AUTO1 in pediatric ALL as part of a pediatric investigational program (PIP). Next data update from CARPALL clinical trial is expected at ASH (Free ASH Whitepaper) 2019. Development program includes a next generation version of AUTO1 (AUTO1NG), which incorporates the CD19 CAR of AUTO1 and a novel CD22 CAR. First preclinical data on CD22 CAR expected to be presented at ASH (Free ASH Whitepaper) 2019.

Additional presentations targeted for ASH (Free ASH Whitepaper) 2019 are: data from AMELIA clinical trial of AUTO3 in pediatric ALL and data from clinical trial of AUTO2 in multiple myeloma.

Next generation (NG) programs for AUTO1, AUTO2, AUTO3 and AUTO6 are expected to enter the clinic in 2020.
"This quarter we have focused on expanding operations at our clinical manufacturing site at the Catapult Cell and Gene facility in Stevenage, UK, enabling us to meet our expected clinical trial demand, including a registration trial with AUTO1. In April, we presented encouraging data on our ALLCAR19 clinical trial of AUTO1 in adult ALL. These data show that AUTO1 is well differentiated from the standard of care in ALL and other CAR T products in development, reaching a high level of clinical activity without inducing severe cytokine release syndrome," stated Dr. Christian Itin, chairman and chief executive officer of Autolus. "For the remainder of 2019, our efforts are focused on moving AUTO1 into a Phase 2 registration trial in adult ALL and advancing AUTO3 in DLBCL toward a Phase 2 decision point in Q2 2020."

Financial results for second quarter 2019:

Cash and equivalents at June 30, 2019 totaled $266.2 million, compared with $217.5 million at December 31, 2018.

Net total operating expenses for the three months ended June 30, 2019 were $37.2 million, net of grant income of $0.3 million, as compared to net operating expenses of $16.5 million, net of grant income of $0.4 million, for the same period in 2018. The increase was due, in general, to the increase in development activity; increased headcount primarily in our development and manufacturing functions; and the cost of being a public company.

Research and development expenses increased to $26.2 million for the three months ended June 30, 2019 from $8.9 million for the three months ended June 30, 2018. Cash costs, which exclude depreciation as well as share-based compensation, increased to $20.2 million from $7.1 million. The increase in research and development cash costs of $13.1 million consisted primarily of an increase of compensation-related costs of $5.6 million primarily due to an increase in headcount to support the advancement of our product candidates in clinical development, an increase of $2.3 million in facilities costs supporting the expansion of our research and translational science capability and investment in manufacturing facilities and equipment, an increase of $3.3 million in research and development program expenses related to the activities necessary to prepare, activate, and monitor clinical trial programs, an increase of $0.8 million in professional fees, an increase of $0.5 million in telecom and software costs, and other additional costs in the amount of $0.4 million.

General and administrative expenses increased to $11.4 million for the three months ended June 30, 2019 from $8.1 million for the three months ended June 30, 2018. Cash costs, which exclude depreciation as well as share-based compensation, increased to $7.3 million from $6.9 million. The increase of $0.4 million consisted primarily of an increase in commercial costs of $1.2 million, compensation-related expense of $0.5 million due to an overall increase in headcount, offset by a decrease in legal and professional fees of $1.3 million related to certain corporate reorganization costs that were incurred in the three months ended June 30, 2018.

Net loss attributable to ordinary shareholders was $28.5 million for the three months ended June 30, 2019, compared to $7.7 million for the same period in 2018.

The basic and diluted net loss per ordinary share for the three months ended June 30, 2019 totaled $(0.65) compared to a basic and diluted net loss per ordinary share of $(0.26) for the three months ended June 30, 2018.

Autolus anticipates that cash on hand provides a runway into the second half of 2021.
Conference Call and Presentation Information

Autolus management will host a conference call today, August 8, at 8:30 a.m. EDT/ 1:30pm BST, to discuss the company’s financial results and operational update.

To listen to the webcast and view the accompanying slide presentation, please go to: View Source

The call may also be accessed by dialing (866) 679-5407 for U.S. and Canada callers or (409) 217-8320 for international callers. Please reference conference ID 2763978. After the conference call, a replay will be available for one week. To access the replay, please dial (855) 859-2056 for U.S. and Canada callers or (404) 537-3406 for international callers. Please reference conference ID 2763978.

On August 8, 2019 Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported financial results and a business update for the second quarter ended June 30, 2019 (Press release, Mersana Therapeutics, AUG 8, 2019, View Source [SID1234538382]).

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"In the second quarter, we reported encouraging clinical activity and tolerability for our first-in-class, wholly-owned ADC candidate, XMT-1536, in heavily pretreated cancer patients without selection for NaPi2b expression," said Anna Protopapas, President and CEO of Mersana Therapeutics. "We are on track with the execution of our 2019 goals, including selecting a dose and initiating enrollment in the Phase 1 expansion study of XMT-1536 and bringing forward our next ADC candidate."

Recent Highlights and Updates

Clinical Program

·Presented interim Phase 1 data for XMT-1536 at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2019. XMT-1536 is a first-in-class, wholly-owned Dolaflexin ADC targeting NaPi2b, which is broadly expressed in epithelial ovarian cancer and non-small cell lung cancer (NSCLC) adenocarcinoma. These data showed that XMT-1536 is clinically active at well-tolerated doses in heavily pretreated and unselected patients. As of May 10, 2019, the data cutoff date for the ASCO (Free ASCO Whitepaper) disclosure, XMT-1536 was well-tolerated at doses up to 30 mg/m2, with observation of objective responses at 20 mg/m2 and higher. Patients (N=37) were heavily pretreated, with a median of four prior lines of treatment (range 1-13) for all patients and a median of five lines of prior treatment in ovarian cancer patients (range 1-11). Interim results included:

·The most common treatment-related adverse events (TRAEs) were Grade 1-2 nausea, fatigue, and headache, and the most frequent Grade 3 TRAE was transient AST elevation without associated changes in bilirubin.

.In patients with tumor types selected for the planned expansion phase (platinum-resistant ovarian cancer and NSCLC adenocarcinoma) treated at >20 mg/m2 (N=18), three (17%) achieved partial responses (PRs) and eight (44%) achieved stable disease (SD) for a disease control rate (DCR) of 11/18 (61%), and a treatment duration lasting beyond 16 weeks in 9 patients (50%).

·In ovarian cancer patients treated at >30 mg/m2 (N=7), two (28%) achieved partial responses (PRs) and three (43%) achieved stable disease (SDs) for a disease control rate (DCR) of 5/7 (71%), and three of these patients (43%) were treated on study for more than 16 weeks.

·The Phase 1 dose escalation study of XMT-1536 for the treatment of NaPi2b-expressing cancers remains ongoing. The Company continues to evaluate patients in the 36 mg/m2 once-every-four-week dosing cohort and the maximum tolerated dose has not yet been reached. The Company expects to select a dose and initiate expansion cohorts in the third quarter of 2019.

·Site initiation continues for the dose expansion portion of the XMT-1536 Phase 1 study. Mersana continues to add sites in anticipation of dosing patients in the expansion groups in the third quarter of 2019. In the first group, the Company plans to enroll platinum-resistant ovarian cancer patients who have failed standard therapy. The second patient group will enroll NSCLC adenocarcinoma patients who have failed front line platinum-based chemotherapy with anti-PD-1 or anti-PD-L1 therapy.

Discovery & Platform Progress

·Mersana expects to disclose its next ADC clinical candidate around year end, further strengthening its scientific leadership in ADC development. The Company is targeting the filing of its next Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) in the first half of 2020.

Corporate Updates

·Completed non-dilutive debt financing for additional financial flexibility. On May 8, 2019, the Company completed a non-dilutive debt financing with Silicon Valley Bank (SVB) that provides Mersana with the ability to draw up to $20.0 million, the proceeds of which will be used for general corporate and working capital purposes.

·Added significant strategic and operational expertise in oncology to Mersana’s leadership team. On June 12, 2019, the Company announced the appointment of Brian C. DeSchuytner as Senior Vice President of Finance and Product Strategy. Mr. DeSchuytner is an accomplished life science professional with nearly two decades of experience spanning corporate strategy, finance, product development, and commercial launch. Most recently, Mr. DeSchuytner was Vice President responsible for ZEJULA (niraparib) commercialization in ovarian cancer at TESARO. Prior to that he was Vice President responsible for the NINLARO (ixazomib) global launch at Takeda Oncology. Earlier in his career, Brian held corporate development and strategy roles of increasing responsibility at Takeda Oncology and was a leader in the life sciences practice of L.E.K. Consulting.

Upcoming Events

·The Company will give a corporate presentation on August 13, 2019, at the 2019 Wedbush PacGrow Healthcare Conference in New York City.

·The Company will give a corporate presentation on September 4, 2019, at the Baird Healthcare Conference in New York City.

·The Company will give a corporate presentation at the H.C. Wainwright Healthcare Conference in New York City taking place from September 8 to 10, 2019.

· The Company will present preclinical data from its proprietary, novel Immunosynthen platform at the upcoming 10th Annual World ADC conference on October 9, 2019 in San Diego, CA.

2019 Financial Results

·Cash, cash equivalents and marketable securities as of June 30, 2019, were $128.2 million, compared to $70.1 million as of December 31, 2018. On March 5, 2019 the Company completed a public equity offering with gross proceeds of $97.8 million. On May 8, 2019, the Company completed a non-dilutive debt financing with Silicon Valley Bank (SVB) that provides Mersana with the ability to draw up to $20.0 million. The Company drew $5.0 million upon the execution of the agreement. The Company used net cash of $14.2 million in operations in the second quarter of 2019. The Company expects that its cash, cash equivalents and marketable securities will enable it to fund its operating plan into at least mid-2021.

Second Quarter 2019

·Collaboration revenue for the second quarter 2019 was approximately $0.2 million, compared to $4.2 million for the same period in 2018. The decrease in collaboration revenue was primarily a result of the termination of the XMT-1522 collaboration with Takeda, the timing of efforts to support partner programs, and the recognition of a milestone payment during the three months ended June 30, 2018.

·Research and development expenses for the second quarter 2019 were approximately $13.8 million, compared to $12.7 million for the same period in 2018, driven primarily by an increase in external costs for the Company’s next clinical candidate as well as modest increases in headcount and facilities costs. The increase was offset by a decrease in external clinical and regulatory expenses due to the discontinuation of the XMT-1522 clinical program and timing of manufacturing costs for XMT-1536.

·General and administrative expenses for the second quarter 2019 remained flat at $4.2 million, compared to the same period in 2018. An increase in employee-related expenses was primarily due to an increase in headcount, but that increase was offset by a decrease in consulting and professional fees.

·Net loss for the second quarter 2019 was $17.1 million, or $0.36 per share, compared to a net loss of $12.4 million, or $0.54 per share, for the same period in 2018. Weighted average common shares outstanding for the quarters ended June 30, 2019 and June 30, 2018, were 47,708,085 and 22,966,314 respectively.

Conference Call

Mersana Therapeutics will host a conference call and webcast today at 8:00 a.m. ET to report financial results for the second quarter of 2019 and provide certain business updates. To access the call, please dial 877-303-9226 (domestic) or 409-981-0870 (international) and provide the Conference ID 5554418. A live webcast of the presentation will be available on the Investors & Media section of the Mersana website at www.mersana.com.

About XMT-1536

XMT-1536 is a Dolaflexin ADC targeting the sodium-dependent phosphate transport protein (NaPi2b) and is comprised of an average of 10-15 DolaLock payload molecules conjugated to XMT-1535, a proprietary humanized anti-NaPi2b antibody. NaPi2b is an antigen expressed in the majority of non-small cell lung cancer (NSCLC) adenocarcinoma and ovarian cancer. XMT-1536 is in Phase 1 clinical trials in patients with tumors expressing NaPi2b, including ovarian cancer, NSCLC adenocarcinoma and other cancers. More information on the ongoing Phase 1 clinical trial can be found at clinicaltrials.gov.

On August 8, 2019 Cytokinetics, Incorporated (Nasdaq:CYTK) reported financial results for the second quarter of 2019 (Press release, Cytokinetics, AUG 8, 2019, View Source [SID1234538418]). Net loss for the second quarter was $32.1 million, or $0.56 per share, compared to net loss for the second quarter of 2018 of $27.5 million, or $0.51 per share. Cash, cash equivalents and investments totaled $175.1 million at June 30, 2019.

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"During the second quarter, we made progress across the breadth of our pipeline, with particular emphasis on our investigational medicines for cardiovascular diseases of muscle dysfunction," said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. "Our recently completing enrollment in GALACTIC-HF represents a significant milestone towards potentially bringing forward a novel therapy to address the high mortality and hospitalization rates in patients with heart failure. Additionally, we are pleased with encouraging data arising from the Phase 1 study of CK-274 and look forward to the planned initiation of a Phase 2 trial in patients with obstructive hypertrophic cardiomyopathy later this year. Our leadership in muscle biology affords us multiple opportunities to advance our drug candidates as our clinical trials generate clinical evidence to support the promise of potential new therapies."

Recent Highlights

Cardiac Muscle Programs

omecamtiv mecarbil (cardiac myosin activator)

Continued conduct of 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. In July 2019 we announced the completion of patient enrollment in GALACTIC-HF, having enrolled over 8,200 patients in 35 countries. We expect GALACTIC-HF to continue throughout 2019 and the next planned interim analysis in the first half of 2020.

Continued conduct of METEORIC-HF, (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure), the second Phase 3 trial of omecamtiv mecarbil. METEORIC-HF is a randomized, placebo-controlled, double-blind, parallel group, multicenter clinical trial designed to evaluate the effect of treatment with omecamtiv mecarbil compared to placebo on exercise capacity as determined by cardiopulmonary exercise testing (CPET) following 20 weeks of treatment. We expect to continue enrollment of METEORIC-HF throughout 2019.
AMG 594 (cardiac troponin activator)

Continued conduct of the Phase 1 study of AMG 594 to assess its safety, tolerability, pharmacokinetics and potential to increase cardiac function in healthy volunteers. AMG 594 is a novel, selective, oral, small molecule cardiac troponin activator, discovered under a joint research program with Amgen. This Phase 1 study is being conducted by Amgen in collaboration with Cytokinetics. We expect the conduct of this study to continue throughout 2019.
CK-3773274 (CK-274, cardiac myosin inhibitor)

Continued conduct of the Phase 1 double-blind, randomized, placebo-controlled, multi-part, single and multiple ascending dose clinical study of CK-274 in healthy adult subjects. CK-274 is a wholly-owned, novel cardiac myosin inhibitor, discovered by company scientists, in development for the potential treatment of hypertrophic cardiomyopathy (HCM). Results from the Phase 1 study have been accepted for presentation at the 23rd Annual Heart Failure Society of America (HFSA) Scientific Meeting in Philadelphia in September 2019.

Received feedback from FDA regarding the design of a planned Phase 2 clinical trial of CK-274 and made preparations for the start of that trial which we expect to begin in the fourth quarter of this year.

Presented preclinical data at the American Heart Association’s Basic Cardiovascular Sciences (BCVS) Scientific Sessions in Boston demonstrating that CK-274 produces exposure related effects on cardiac contractility in healthy animals and mouse models of HCM and support the therapeutic hypothesis relating to onset of action and reversibility.
Skeletal Muscle Program

reldesemtiv (next-generation fast skeletal muscle troponin activator (FSTA))

Presented results from FORTITUDE-ALS (Functional Outcomes in a Randomized Trial of Investigational Treatment with CK-2127107 to Understand Decline in Endpoints – in ALS), the Phase 2 clinical trial of reldesemtiv in patients with amyotrophic lateral sclerosis (ALS) at the American Academy of Neurology 71st Annual Meeting in Philadelphia. FORTITUDE-ALS did not achieve statistical significance for a pre-specified dose-response relationship in its primary endpoint of change from baseline in slow vital capacity (SVC) after 12 weeks of dosing (p=0.11). Patients on all dose groups of reldesemtiv declined less than patients on placebo for SVC and ALSFRS-R, with larger and clinically meaningful differences emerging over time. While the dose-response analyses for the primary and secondary endpoints did not achieve statistical significance at the level of 0.05, in a post-hoc analysis pooling the doses together, the ALSFRS-R total score in patients who received reldesemtiv declined less than patients who received placebo (p = 0.01). The trial showed effects favoring reldesemtiv across dose levels and timepoints with clinically meaningful magnitudes of effect observed at 12 weeks for the primary and secondary endpoints.

Continued to analyze results from FORTITUDE-ALS to inform the design of a potential Phase 3 trial and registration program that may begin in 2020.

Concluded a Phase 1 study of reldesemtiv in healthy volunteers designed to assess higher doses and related plasma exposures than were evaluated in the prior Phase 2 study of patients with SMA. We are evaluating the data from the study to inform the design of potential future clinical trials.

Presented data from two preclinical studies of reldesemtiv at the 2019 Annual Cure SMA Conference in Anaheim, CA, showing that the addition of reldesemtiv to treatment with SMN upregulators (nusinersen and SMN-C1, an analogue to risdiplam) significantly increased muscle force in a mouse model of spinal muscular atrophy (SMA).
Pre-Clinical Development and Ongoing Research

Continued pre-clinical development of CK-3762601 (CK-601), a next-generation fast skeletal muscle troponin activator (FSTA), under our collaboration with Astellas.

Continued research in collaboration with Astellas directed to the discovery of next-generation skeletal muscle activators; Astellas is sponsoring Cytokinetics’ research activities through 2019.

Continued independent research activities directed to our other muscle biology research programs.
Corporate

We are currently in discussions with Astellas regarding amending the terms of our collaboration agreement, including, for reldesemtiv, the level of potential funding and share of commercial returns, as well as which company would be responsible for development and commercialization.

Announced the continuation of our partnership with The ALS Association in the fight against ALS with renewal of Gold Level Sponsorship of the National Walks to Defeat ALS and Premier Level National ALS Advocacy Conference Sponsorship as well as Platinum Level Sponsorship for initiatives led by The ALS Association Golden West Chapter, including grant funding for care services for people living with ALS in the San Francisco Bay Area.
Financials

Revenues for the three and six months ended June 30, 2019 were $7.1 million and $15.6 million, respectively, compared to $6.2 million and $11.5 million for the corresponding periods in 2018. The increase in revenues for the three and six month ended June 30, 2019 was due primarily to reimbursements for METEORIC-HF offset by no license revenue in 2019. License revenues in the second quarter and first half of 2018 were related to the Phase 2 study of reldesemtiv in spinal muscular atrophy completed in 2018.

Research and development expenses for the three and six months ended June 30, 2019 increased to $24.0 million and $47.6 million, respectively compared to $21.6 million and $43.7 million for the same periods in 2018, respectively due to increased spending related to METEORIC-HF and the development of CK-274, offset in part by reduced spending for reldesemtiv as well as for tirasemtiv, following suspension of development of tirasemtiv in late 2017.

General and administrative expenses for the three and six months ended June 30, 2019 increased to $9.8 million and $19.3 million from $8.0 million and $17.3 million in 2018 due primarily to an increase in outside legal counsel and personnel related costs.

Conference Call and Webcast Information

Members of Cytokinetics’ senior management team will review the company’s second quarter 2019 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 1778276.

An archived replay of the webcast will be available via Cytokinetics’ website until August 15, 2019. 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 1778276 from August 8, 2019 at 7:30 PM Eastern Time until August 15, 2019.

On August 8, 2019 BioLife Solutions, Inc. (NASDAQ: BLFS) ("BioLife" or the "Company"), a leading developer and supplier of a portfolio of best-in-class bioproduction tools for cell and gene therapies, reported financial results and operational highlights for the three and six months ended June 30, 2019 (Press release, BioLife Science, AUG 8, 2019, View Source [SID1234538468]).

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Revenue from biopreservation media and automated thaw product sales for the second quarter of 2019 reached a record of $6.7 million, an increase of 29% compared with the second quarter of 2018. For the first half of 2019 revenue totaled $12.5 million, representing an increase of 39% compared with the prior-year period. Product revenue growth for both periods was driven by sales of CryoStor and HypoThermosol biopreservation media and the recently acquired ThawSTAR automated thaw products to the high-growth cell and gene therapy market.

Mike Rice, BioLife President & CEO, commented, "Throughout the second quarter, we demonstrated our ability to efficiently manage our business during a sustained period of rapid growth. Demand for our proprietary biopreservation media products continues to be strong from new and existing customers. During the quarter we received 14 new cross-reference requests for our FDA master files from cell and gene therapy companies who intend to use CryoStor and/or HypoThermosol in upcoming clinical trials. Based on these new requests, direct customer forecasts and anticipated demand from our worldwide network of distributors, we are optimistic about how the business will perform for the balance of 2019.

"We also realized strong initial demand for automated thaw products in our first full quarter following the acquisition of Astero Bio, with 39 new customer orders. Of note, most of these customers came from the cell and gene therapy segment. We look forward to a Q4 launch of a new ThawSTAR CB automated thaw product for large volume cell and gene therapies to be frozen in cryobags. With respect to SAVSU, we remain bullish on our ability to capture a significant share of the cell and gene therapy cold chain management market. Since January 2019, the evo system has been used in initial shipments by more than 50 cell and gene therapy companies. We look forward to integrating our sales and marketing activities and exhibiting our expanded product portfolio at 10 cell and gene therapy scientific conferences throughout the rest of the year."

Second Quarter 2019 Revenue Highlights

Cell & Gene Therapy Market Segment

Total product revenue: $4.0 million; representing 59% of total revenue with 33% growth over the same period last year.
Shipped initial orders to 51 new biopreservation media customers and 39 new automated thaw products customers, most of which were cell and gene therapy companies in the regenerative medicine market segment.
Received 14 new cross-reference requests for our FDA master files for CryoStor and HypoThermosol.
Worldwide Distributor Network

Product revenue: $2.2 million; representing 33% of total revenue with 31% growth over the same period last year.
Key worldwide distributors include: STEMCELL Technologies, MilliporeSigma, Thermo Fisher and VWR.
Second Quarter and Six Month 2019 Financial Results

BioLife Solutions is presenting various financial metrics under U.S. Generally Accepted Accounting Principles (GAAP) and as adjusted (non-GAAP) to reflect acquisition-related activity. A reconciliation of GAAP to non-GAAP metrics appears at the end of this news release.

Revenue

Total revenue for the second quarter of 2019 increased 29% to $6.7 million compared with $5.2 million for the second quarter of 2018.
Sales of ThawSTAR automated thaw products totaled $374,000 in the second quarter.
Total revenue for the six months ended June 30, 2019 increased 39% to $12.5 million compared with $9.0 million for the first six months of 2018.
Gross Margin

Gross margin (GAAP) for the second quarter of 2019 increased to 70.8% from 70.3% in the second quarter of 2018. Adjusted gross margin (non-GAAP) for the second quarter of 2019 increased to 72.3% from 70.3% in 2018.
Gross margin (GAAP) for the six months ended June 30, 2019 increased to 71.1% from 67.7% for the same period in 2018. Adjusted gross margin (non-GAAP) for the six months ended June 30, 2019 increased to 71.9% from 67.7% in 2018.
Operating Expenses

Operating expenses (GAAP) for the second quarter of 2019 were $3.8 million compared with $2.4 million for the second quarter of 2018. Adjusted operating expenses (non-GAAP) for the second quarter of 2019 were $3.7 million compared with $2.4 million in 2018.
Operating expenses (GAAP) for the six months ended June 30, 2019 were $7.5 million compared with $4.7 million for the same period in 2018. Adjusted operating expenses (non-GAAP) for the six months ended June 30, 2019 were $7.1 million compared with $4.7 million in 2018.
Operating Income

Operating income (GAAP) for the second quarter of 2019 was $919,000 compared with $1.3 million for the second quarter of 2018. Adjusted operating income (non-GAAP) for the second quarter of 2019 was $1.2 million compared with $1.3 million in 2018.
Operating income (GAAP) for the six months ended June 30, 2019 was $1.4 million compared with $1.4 million for the same period in 2018. Adjusted operating income (non-GAAP) for the six months ended June 30, 2019 was $1.9 million compared with $1.4 million in 2018.
Net Income Attributable to Common Stockholders

Net income attributable to common stockholders (GAAP) for the second quarter of 2019 was $838,000 compared with $1.0 million for the second quarter of 2018. Adjusted net income attributable to common stockholders (non-GAAP) for the second quarter of 2019 was $1.1 million compared with $1.0 million in 2018.
Net income attributable to common stockholders (GAAP) for the six months ended June 30, 2019 was $1.3 million compared with $943,000 for the same period in 2018. Adjusted net income attributable to common stockholders (non-GAAP) for the six months ended June 30, 2019 was $1.7 million compared with $943,000 in 2018.
Earnings per Share

Earnings per diluted share (GAAP) for the second quarter of 2019 were $0.03 compared with $0.05 for the second quarter of 2018. Adjusted earnings per diluted share (non-GAAP) for the second quarter of 2019 were $0.04 compared with $0.05 in 2018.
Earnings per diluted share (GAAP) for the six months ended June 30, 2019 were $0.05 compared with $0.05 for the same period in 2018. Adjusted earnings per diluted share (non-GAAP) for the six months ended June 30, 2019 were $0.07 compared with $0.05 in 2018.
EBITDA

EBITDA, a non-GAAP measurement, for the second quarter of 2019 was $917,000 compared with $1.2 million for the second quarter of 2018. Adjusted EBITDA for the second quarter of 2019 was $1.9 million compared with $1.7 million in 2018.
EBITDA, a non-GAAP measurement, for the six months ended June 30, 2019 was $1.3 million compared with $1.3 million for the same period in 2018. Adjusted EBITDA for the six months ended June 30, 2019 was $3.3 million compared with $2.3 million in 2018.
Cash

Cash and cash equivalents as of June 30, 2019 were $19.6 million compared with $30.7 million as of December 31, 2018. The decrease reflects $12.5 million in cash consideration paid in conjunction with the acquisition of Astero Bio Corporation, which closed in early April.
Roderick de Greef, BioLife Chief Financial Officer, remarked, "In addition to successfully integrating Astero’s operations during the second quarter, our financial results at all levels remained strong."

2019 Financial Guidance

Management updated 2019 financial guidance to include contributions from Astero (beginning April 1) and SAVSU (beginning August 8), as follows:

Total revenue of $27.5 million to $30.5 million, representing growth of 39% to 55% over 2018.
Gross margin is expected to be in a range of 69% to 70% on a GAAP and non-GAAP basis, compared with 69% in 2018.
Operating expenses on a GAAP basis ranging from $18.5 to $19.5 million, up from previous guidance of $15.5 to $16.5 million as a result of acquisition costs, amortization of intangible assets and the addition of SAVSU related operating expenses. Adjusted operating expenses (non-GAAP) ranging from $17 to $18 million.
Full-year positive adjusted operating income, adjusted net income and adjusted EBITDA.
Conference Call & Webcast

The Company will host a conference call and live webcast at 4:30 p.m. ET this afternoon. To access the live webcast, please go to www.biolifesolutions.com/earnings/. Alternatively, you may access the live conference call by dialing (844) 825-0512 (U.S. & Canada) or (315) 625-6880 (International) with the following Conference ID: 1368786. A webcast replay will be available approximately two hours after the call and will be archived on www.biolifesolutions.com for 90 days.