On May 2, 2019 Bio-Techne Corporation (NASDAQ:TECH) reported that Jim Hippel, Chief Financial Officer will present at the Bank of America Merrill Lynch 2019 Health Care Conference on Wednesday, May 15th, 2019, at 2:20 p.m. PDT (Press release, Bio-Techne, MAY 2, 2019, View Sourcenews/detail/137/bio-techne-to-present-at-the-bank-of-america-merrill-lynch-2019-health-care-conference" target="_blank" title="View Sourcenews/detail/137/bio-techne-to-present-at-the-bank-of-america-merrill-lynch-2019-health-care-conference" rel="nofollow">View Source [SID1234536924]). The conference will be held at the Encore Hotel in Las Vegas, NV.

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A live webcast of the presentation can be accessed via Bio-Techne’s Investor Relations website at View Source or through the following link http://www.veracast.com/webcasts/baml/healthcare2019/id88209456501.cfm.

On May 2, 2019 CTI BioPharma Corp. (Nasdaq: CTIC) reported its financial results for the first quarter ended March 31, 2019 (Press release, CTI BioPharma, MAY 2, 2019, View Source [SID1234535548]).

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"Advancing our U.S. and European development program for pacritinib for the treatment of myelofibrosis patients with severe thrombocytopenia remains our top priority for 2019, and we anticipate multiple important milestone events for pacritinib this year," said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI BioPharma. "We are currently preparing to meet with the U.S. Food and Drug Administration (FDA) and report the determination of an optimal dose of pacritinib in mid-2019, and we expect to begin enrolling a Phase 3 registration study of pacritinib soon after. We also anticipate announcing top-line safety and efficacy data from the Phase 2 study of pacritinib and are targeting presentation of the results at a scientific conference before the end of the year."

Expected 2019 Milestones

FDA meeting and determination of the optimal dose of pacritinib – mid-2019

Commence enrollment in Phase 3 study of pacritinib in myelofibrosis patients with severe thrombocytopenia (platelet counts of less than 50,000 per microliter) – Q3 2019

Reporting of top-line efficacy and safety data from PAC203 Phase 2 study at a major medical meeting by the end of 2019

First Quarter Financial Results
Total revenues for the three months ended March 31, 2019 were $0.6 million compared to $10.8 million for the same period in 2018. The decrease in total revenues for the first quarter in 2019 compared to the same period in 2018 is primarily due to the recognition of $10.0 million in license and contract revenue in 2018 from Teva Pharmaceutical Industries Ltd. related to the achievement of a milestone for FDA approval of TRISENOX (arsenic trioxide) for first-line treatment of acute promyelocytic leukemia.

Operating loss was $10.5 million for the first quarter of 2019, compared to operating loss of $4.3 million for the same period in 2018. Operating loss in the first quarter of 2019 as compared to operating loss in the same period in 2018 resulted primarily from the decrease in license and contract revenue as mentioned above.

Net loss attributable to common stockholders for the first quarter of 2019 was $10.8 million, or $(0.19) for basic and diluted loss per share, compared to net loss attributable to common stockholders of $4.1 million, or $(0.08) for basic and diluted loss per share, for the same period in 2018.

As of March 31, 2019, cash, cash equivalents and short-term investments totaled $62.3 million, compared to $67.0 million as of December 31, 2018. CTI BioPharma expects current cash, cash equivalents and short-term investments will enable it to fund operating and capital expenditures through the second quarter of 2020.

On May 2, 2019 vTv Therapeutics Inc. (Nasdaq:VTVT) reported financial results for the first quarter that ended March 31, 2019, and provided an update on recent achievements and upcoming events (Press release, vTv Therapeutics, MAY 2, 2019, View Source;p=irol-newsArticle&ID=2396694 [SID1234535564]).

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"We continue to make significant progress with our operational plans and look forward to announcing in the second quarter results from part 1 of our phase 2 Simplici-T1 trial in patients with type 1 diabetes, and the initiation of a phase 2 clinical trial of azeliragon in patients with mild-Alzheimer’s disease (AD) and type 2 diabetes," said Steve Holcombe, chief executive officer, vTv Therapeutics.

Recent Achievements and Outlook

Simplici-T1 Study enrolling patients with type 1 diabetes. We completed enrollment of part 1 of the phase 2 Simplici-T1 Study, a 12-week study to evaluate TTP399 as an add-on to insulin therapy for patients with type 1 diabetes, and expect to report results in June 2019. We also began screening patients in the part 2 confirmatory phase 2 and expect to report results for that portion of the study in the latter part of the first quarter of 2020. In the previous AGATA Study, a phase 2 study in type 2 diabetes patients, TTP399 demonstrated statistically significant reductions in HbA1c levels. Importantly, TTP399 has been well tolerated in all clinical studies to date with negligible incidences of hypoglycemia and hyperlipidemia and no occurrences of ketoacidosis.
Screening for Phase 2 clinical trial of azeliragon expected to begin in June 2019. We are performing start-up activities for a clinical trial to evaluate azeliragon as a potential treatment of mild-AD in patients with type 2 diabetes that consists of sequential phase 2 and phase 3 studies operationally conducted under a single clinical trial protocol. The phase 2 study is designed to enroll approximately 100 patients to evaluate the impact of six months of treatment with azeliragon on cognitive performance as measured by the change from baseline in the Alzheimer’s Disease Assessment Scale – Cognitive Subscale ("ADAS-COG14"). We expect to begin screening patients in June 2019 for the phase 2 clinical trial and to report top-line results from the phase 2 study by the end of the fourth quarter of 2020. The phase 3 study is designed to enroll approximately 200 patients to evaluate the efficacy of 18 months of treatment with azeliragon on cognition and global function as measured by the change from baseline in the ADAS-COG14 and Clinical Dementia Rating Scale Sum of Boxes. The design of the phase 3 study may be adapted based on the results of the phase 2 study.
Publication of paper discussing the discovery and development of TTP399. In the first quarter, we announced the publication of a paper in Science Translational Medicine showcasing the discovery and development of TTP399. The paper reviewed the scientific rationale underpinning the development of TTP399 and detailed its progression from preclinical to clinical development.
First Quarter 2019 Financial Results

Cash Position: Cash and cash equivalents as of March 31, 2019, were $5.0 million compared to $1.7 million as of December 31, 2018.
R&D Expenses: Research and development expenses were $2.8 million in each of the first quarter of 2019 and the fourth quarter of 2018.
G&A Expenses: General and administrative expenses were $2.4 million and $2.1 million in the first quarter of 2019 and the fourth quarter of 2018, respectively.
Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $4.0 million for the first quarter of 2019 compared to net loss before non-controlling interest of $2.3 million for the fourth quarter of 2018.
Net Loss Per Share: GAAP net loss per share was $0.26 and $0.10 for the three months ended March 31, 2019 and December 31, 2018, respectively, based on weighted-average shares of 22.9 million and 17.6 million for the three month periods ended March 31, 2019 and December 31, 2018, respectively. Adjusted pro forma net loss per fully exchanged share was $0.09 and $0.06 for the three months ended March 31, 2019 and December 31, 2018, respectively, based on adjusted pro forma fully exchanged weighted-average shares of 46.0 million and 40.7 million for the three months ended March 31, 2019 and December 31, 2018, respectively.

On May 2, 2019 Novocure (NASDAQ: NVCR) reported financial results for the quarter ended March 31, 2019, highlighting continued revenue growth, an advancing clinical pipeline and a strong cash position (Press release, NovoCure, MAY 2, 2019, Novocure Reports First Quarter 2019 Financial Results and Provides Company Update [SID1234535580]). Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, Tumor Treating Fields.

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Novocure reports first quarter 2019 financial results and provides company update

(1)An "active patient" is a patient who is on Optune under a commercial prescription order as of the measurement date, including patients who may be on a temporary break from treatment and who plan to resume treatment in less than 60 days.

(2)A "prescription received" is a commercial order for Optune that is received from a physician certified to treat patients with Optune for a patient not previously on Optune. Orders to renew or extend treatment are not included in this total.

"With more than 2,600 patients on Optune as of March 31, 2019, we delivered another quarter of strong financial performance. We posted $73.3 million in net revenues in the first quarter 2019 with year-over-year revenue growth of 41 percent," said Asaf Danziger, Novocure’s Chief Executive Officer. "We also strengthened our balance sheet, adding more than $10 million in cash, cash equivalents and short-term investments in the first quarter. We continued to fund our increased investments in clinical trials and Optune technology improvements with cash flow from the GBM business."

"Our clinical pipeline continues to advance. Our HDE application for malignant pleural mesothelioma is under review at the FDA and, with the first patient enrolled in our INNOVATE-3 trial in March, enrollment is now ongoing in four phase 3 pivotal trials, creating a significant market expansion opportunity," added William Doyle, Novocure’s Executive Chairman. "We believe we are at an important inflection point, transitioning to cash generation while expanding globally, driving clinical trials and investing in technology improvements as we work to extend survival in some of the most aggressive forms of cancer."

First quarter 2019 operating statistics and financial update

There were 2,631 active patients on Optune at March 31, 2019, representing 31 percent growth versus March 31, 2018, and 10 percent growth versus December 31, 2018. The increase in active patients was driven primarily by prescription growth in EMEA and Japan and the ongoing benefit from continued growth in prescriptions for patients with newly diagnosed GBM globally.

In the United States, there were 1,778 active patients on Optune at March 31, 2019, representing 23 percent growth versus March 31, 2018.
In Germany and other EMEA markets, there were 735 active patients on Optune at March 31, 2019, representing 35 percent growth versus March 31, 2018.
In Japan, there were 118 active patients on Optune at March 31, 2019, representing 490 percent growth versus March 31, 2018.
Additionally, 1,310 prescriptions were received in the three months ended March 31, 2019, representing four percent growth compared to the same period in 2018, and flat versus the three months ended December 31, 2018.

In the United States, 925 prescriptions were received in the three months ended March 31, 2019, representing a two percent decline compared to the same period in 2018.
In Germany and other EMEA markets, 330 prescriptions were received in the three months ended March 31, 2019, representing 17 percent growth compared to the same period in 2018.
In Japan, 55 prescriptions were received in the three months ended March 31, 2019, representing 83 percent growth compared to the same period in 2018.
For the three months ended March 31, 2019, net revenues were $73.3 million, representing 41 percent growth versus the same period in 2018. Revenue growth was primarily driven by an increase of 622 active patients in our currently active markets, representing 31 percent growth, and an increase in net revenues per active patient. The increase in net revenues per active patient was primarily driven by improving reimbursement approval rates in Germany and by growth in Austria and Japan.

For the three months ended March 31, 2019, cost of revenues was $19.8 million compared to $18.2 million for the same period in 2018, representing an increase of 9 percent. The increase in cost of revenues was primarily due to the cost of shipping transducer arrays to a higher volume of active patients. Gross margin was 73% for the three months ended March 31, 2019 compared to 65% for the three months ended March 31, 2018.

Research, development and clinical trials expenses for the three months ended March 31, 2019, were $17.0 million compared to $11.1 million for the same period in 2018, representing an increase of 53 percent. This was primarily due to an increase in clinical trial and personnel expenses for our INNOVATE-3, LUNAR, METIS and PANOVA-3 trials and an increase in costs associated with medical affairs, regulatory and engineering.

Sales and marketing expenses for the three months ended March 31, 2019, were $22.3 million compared to $18.1 million for the same period in 2018, representing an increase of 23 percent. This was primarily due to increased marketing expenses and increased personnel costs associated with a larger sales force globally.

General and administrative expenses for the three months ended March 31, 2019, were $20.2 million compared to $17.3 million for the same period in 2018, representing an increase of 17 percent. This was primarily due to an increase in personnel costs and an increase in professional services.

Personnel costs for the three months ended March 31, 2019, included $9.7 million in non-cash share-based compensation expenses, comprised of $0.4 million in cost of revenues; $1.2 million in research, development and clinical trials; $2.0 million in sales and marketing; and $6.1 million in general and administrative expenses. Total non-cash share-based compensation expenses for the first quarter 2018 were $8.5 million.

Net loss for the three months ended March 31, 2019, was $12.2 million, or $0.13 per share, compared to net loss of $20.7 million for the same period in 2018, or $0.23 per share, representing an improvement of 41 percent.

At March 31, 2019, we had $152.1 million in cash and cash equivalents and $104.5 million in short-term investments, for a total balance of $256.6 million in cash, cash equivalents and short-term investments.

Anticipated clinical and regulatory milestones

FDA approval for unresectable malignant pleural mesothelioma (2019)
Zai Lab initiation of phase 2 pilot trial in gastric cancer (2019)
Data from phase 2 pilot HEPANOVA trial in advanced liver cancer (2020)
Interim analysis of phase 3 pivotal LUNAR trial in non-small cell lung cancer (2020)
Data from phase 3 pivotal METIS trial in brain metastases (2021)
Interim analysis of phase 3 pivotal PANOVA-3 trial in locally advanced pancreatic cancer (2021)
Final data from phase 3 pivotal LUNAR trial in non-small cell lung cancer (2021)
Interim analysis of phase 3 pivotal INNOVATE-3 trial in recurrent ovarian cancer (2022)
Final data from phase 3 pivotal PANOVA-3 trial in locally advanced pancreatic cancer (2022)
Final data from phase 3 pivotal INNOVATE-3 trial in recurrent ovarian cancer (2024)
Conference call details

Novocure will host a conference call and webcast to discuss first quarter 2018 financial results today, Thursday, May 2, 2019, at 8 a.m. EDT. Analysts and investors can participate in the conference call by dialing 855-442-6895 for domestic callers and 509-960-9037 for international callers, using the conference ID 8956998.

The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call.

On May 2, 2019 Conatus Pharmaceuticals Inc. (Nasdaq:CNAT) reported financial results for the first quarter ended March 31, 2019, and provided updates on its development programs (Press release, Conatus Pharmaceuticals, MAY 2, 2019, View Source [SID1234535611]).

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Program Updates
The company is currently conducting two double-blind, placebo-controlled Phase 2b clinical trials in collaboration with Novartis – the EmricasaN, a Caspase inhibitOR, for Evaluation (ENCORE) trials, designed to evaluate emricasan, a first-in-class pan-caspase inhibitor, in patients with liver cirrhosis caused by nonalcoholic steatohepatitis (NASH).

The ENCORE-LF (for Liver Function) clinical trial, initiated in the second quarter of 2017, has enrolled approximately 210 patients with stable decompensated NASH cirrhosis. The primary endpoint is event-free survival, which is a composite of all-cause mortality, new decompensation events, or ≥4 points progression in Model for End-stage Liver Disease (MELD) score. Enrollment was completed in the first quarter of 2019. Top-line results triggered by reaching a prespecified number of events are expected in mid-2019.

The ENCORE-PH (for Portal Hypertension) clinical trial, initiated in the fourth quarter of 2016, enrolled 263 patients with compensated or early decompensated NASH cirrhosis and severe portal hypertension. The trial’s primary endpoint was change in mean hepatic venous pressure gradient (HVPG) from baseline to Week 24 in any of three emricasan dosing groups compared with placebo. Top-line results were reported in December 2018 showing HVPG trends consistently favoring emricasan compared with placebo in the overall population but not meeting the primary endpoint. The greatest improvement was observed in patients with a baseline HVPG of 16 mmHg or higher.

Week 24 results from the ENCORE-PH clinical trial were detailed in a late-breaker oral presentation at The International Liver Congress 2019, the Annual Meeting of the European Association for the Study of the Liver (EASL) in Vienna, Austria, on April 13, 2019. The associated abstract was also selected by EASL for inclusion in the "Best of ILC" summary slide deck highlighting the most noteworthy contributions to the scientific program at this year’s meeting. A copy of the presentation is available in the Investors section of the Conatus website at www.conatuspharma.com.

Patients had the option to continue on their assigned doses of treatment or placebo in a double-blind 24-week extension period. Results following the extension period are expected in mid-2019 and will include longer term safety, liver function and clinical outcomes, but there will be no additional HVPG measurements.
During the first quarter of 2019, the company announced top-line results from a third double-blind, placebo-controlled Phase 2b clinical trial, the ENCORE-NF (for NASH Fibrosis) clinical trial in patients with biopsy-confirmed NASH and liver fibrosis. The trial’s primary endpoint was a ≥1 CRN fibrosis stage improvement with no worsening of steatohepatitis compared with placebo at week 72. The trial did not meet the primary endpoint.

The company announced in March 2019 the selection of its first internally developed product candidate, CTS-2090, an orally active inhibitor of caspase 1. Caspase 1 occupies a uniquely central position in the NLRP3 inflammasome pathway and blocks activation of the potent inflammatory cytokine IL-1β. Blocking IL-1β is a clinically validated approach to treating inflammatory diseases, with several injectable biologic products using that mechanism of action already on the market. CTS-2090 is currently in preclinical development and IND-enabling studies, with an initial clinical trial planned to begin by the first half of 2020. The company plans to pursue rare autoinflammatory diseases as initial clinical targets for CTS-2090.

Financial Results
The net loss was $4.7 million for the first quarter of 2019 compared with a net loss of $5.0 million for the first quarter of 2018.

Total revenues were $7.0 million for the first quarter of 2019 compared with $9.7 million for the first quarter of 2018. Total revenues consisted of collaboration revenues related to the Novartis agreement. The decrease in total revenues was primarily due to lower emricasan-related research and development expenses resulting in corresponding lower revenues related to the Novartis agreement.

Research and development expenses were $9.4 million for the first quarter of 2019 compared with $12.1 million for the first quarter of 2018. The decrease in research and development expenses was primarily due to lower spending related to the ENCORE-PH clinical trial and manufacturing activities, partially offset by higher spending related to the ENCORE-LF clinical trial.

General and administrative expenses were $2.6 million for the first quarter of 2019 compared with $2.7 million for the first quarter of 2018.

Cash, cash equivalents and marketable securities were $33.8 million at March 31, 2019, compared with $40.7 million at December 31, 2018, and a projected year-end 2019 balance, without including any potential milestone payments under the Novartis collaboration, of between $10 million and $15 million.