On July 31, 2019 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics (MBTs) to treat age-related diseases, reported that the company will release its second quarter 2019 financial results after the market closes on Wednesday, August 7, 2019 (Press release, CohBar, JUL 31, 2019, View Source [SID1234538024]). Management will host a conference call with a slide presentation at 5:00 p.m. ET (2:00 p.m. PT) on the same day to provide an update on the company’s business.

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Details for the Conference Call and Slide Presentation:

Date: August 7, 2019
Time: 5:00 p.m. ET (2:00 p.m. PT)

Conference Audio
Dial-in U.S. and Canada: (800) 239-9838
Dial-in International: (323) 794-2551
Conference ID No.: 8671787

Slide Presentation
Go to www.webex.com, click on the ‘Join’ button and enter meeting number 923 119 468 and Password CWBR, or
Go to www.cohbar.com and click on Q2 2019 Shareholder Presentation at top of homepage.
For individuals participating in the Investor Call and Slide Presentation, please call into the conference audio and log into Webex approximately 10 minutes prior to its start.

An audio replay of the call will be available beginning at 8:00 p.m. Eastern Time on August 7, 2019, through 11:59 p.m. Eastern Time on August 28, 2019. To access the recording please dial (844) 512-2921 in the U.S. and Canada, or (412) 317-6671 internationally, and reference Conference ID# 8671787. The audio recording along with the slide presentation will also be available at www.cohbar.com during the same period.

On July 31, 2019 Celldex Therapeutics, Inc. (Nasdaq:CLDX) reported that will report second quarter 2019 financial results on Wednesday, August 7, 2019 after the U.S. financial markets close (Press release, Celldex Therapeutics, JUL 31, 2019, View Source [SID1234538023]). Celldex executives will host a conference call at 4:30 p.m. EDT on the same day to review the second quarter 2019 financial results and to provide an update on key research and development and business objectives for the remainder of 2019.

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The conference call and presentation will be webcast live over the Internet and can be accessed by going to the "Events & Presentations" page under the "Investors & Media" section of the Celldex Therapeutics website at www.celldex.com. The call can also be accessed by dialing (866) 743-9666 (within the United States) or (760) 298-5103 (outside the United States). The passcode is 9256839.

A replay of the call will be available approximately two hours after the live call concludes through August 14, 2019. To access the replay, dial (855) 859-2056 (within the United States) or (404) 537-3406 (outside the United States). The passcode is 9256839. The webcast will also be archived on the Company’s website.

On July 31, 2019 vTv Therapeutics Inc. (Nasdaq:VTVT) reported financial results for the second quarter that ended June 30, 2019, and provided an update on recent achievements and upcoming events (Press release, vTv Therapeutics, JUL 31, 2019, View Source [SID1234537979]).

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"We made significant progress during the second quarter," said Steve Holcombe, chief executive officer, vTv Therapeutics. "We reported positive results from part 1 of our phase 2 Simplici-T1 trial in type 1 diabetes and began screening patients for our 488-305 trial evaluating azeliragon in patients with mild Alzheimer’s disease and type 2 diabetes. We look forward to continuing to execute successfully on our development plans for each of these drug candidates and advancing them as potential treatments for patients suffering from these diseases."

Recent Achievements and Outlook

Part 1 of the Simplici-T1 Study achieves positive topline results in patients with type 1 diabetes. In June 2019, we announced positive topline results from 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.

In this double-blind, placebo-controlled 12-week trial, the baseline mean HbA1c for the groups treated with TTP399 and placebo was 7.3% and 7.4%, respectively. Patients treated with TTP399 (n=8) showed a statistically significant mean reduction in HbA1c of 0.6% at 12 weeks, while the group treated with placebo (n=11) showed a mean increase in HbA1c of 0.1%, resulting in a mean improvement of 0.7% in the TTP399 group relative to the placebo group (p=0.03).

TTP399 was well tolerated in the study, with no serious adverse event reported, and no report of diabetic ketoacidosis or severe hypoglycemia.

Simplici-T1 Study enrolling patients in Part 2. In May 2019, we began enrolling patients in the part 2 confirmatory phase of the Simplici-T1 Study and expect to report results for that portion of the study in the latter part of the first quarter of 2020.

Screening patients for Phase 2/3 clinical trial of azeliragon. We began screening patients in June 2019 for a Phase 2 clinical trial to evaluate azeliragon as a potential treatment of mild-AD in patients with type 2 diabetes. The randomized, double-blind, placebo-controlled multicenter trial is designed as sequential phase 2 and phase 3 studies operationally conducted under one protocol. Each part of the study will evaluate the efficacy and safety of azeliragon in patients with mild Alzheimer’s disease (screening MMSE 21 to 26, baseline MMSE 19 to 27; and ADAS-cog14 score ≥10) and type 2 diabetes (screening HbA1c 6.5% to 9.5%, inclusive).

vTv expects to report topline results from the phase 2 proof of concept study by the end of the fourth quarter of 2020.

Upcoming Events

vTv will present additional results from Part 1 of the Simplici-T1 Study at the 55th Annual Meeting of the European Association for the Study of Diabetes in Barcelona Spain, September 16–20, 2019 with a poster entitled "Results from the sentinel and learning phase of the Simplici-T1 study, the first clinical trial to test activation of glucokinase as an adjunctive treatment for type 1 diabetes".

Second Quarter 2019 Financial Results

Cash Position: Cash and cash equivalents as of June 30, 2019, were $1.5 million compared to $5.0 million as of March 31, 2019.

Revenue: Revenues were $1.8 million for the second quarter of 2019 versus $0.9 million in the first quarter of 2019. The increase in revenue was driven by the recognition of $1.0 million for one of our license agreements based on the satisfaction of a development milestone.

R&D Expenses: Research and development expenses were $4.2 million in the second quarter of 2019 and $2.8 million in the first quarter of 2019. This increase in R&D expenses was driven primarily by the increase in costs for the 488-305 Study for which we were performing start-up activities, including site activations, in the second quarter of 2019.

G&A Expenses: General and administrative expenses were $2.4 million in each of the second and first quarters of 2019.

Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $5.1 million for the second quarter of 2019 compared to net loss before non-controlling interest of $4.0 million for the first quarter of 2019.

Net Loss Per Share: GAAP net loss per share was $0.10 and $0.26 for the three months ended June 30, 2019 and March 31, 2019, respectively, based on weighted-average shares of 28.0 million and 22.9 million for the three month periods ended June 30, 2019 and March 31, 2019, respectively. Non-GAAP net loss per fully exchanged share was $0.09 and $0.06 for the three months ended June 30, 2019 and March 31, 2019, respectively, based on non-GAAP fully exchanged weighted-average shares of 51.1 million and 46.0 million for the three months ended June 30, 2019 and March 31, 2019, respectively.

On July 31, 2019 PRA Health Sciences, Inc. ("PRA," "we," "us" or the "Company") (NASDAQ: PRAH) reported financial results for the quarter ended June 30, 2019 (Press release, PRA Health Sciences, JUL 31, 2019, View Source [SID1234537978]).

"Our second quarter financial results produced a record level of net new business awards, solid revenue growth, and continued margin expansion, all of which were in line with our expectations," said Colin Shannon, PRA’s Chief Executive Officer. "Although we have modified our expectations around our 2019 revenue targets, market demand remains strong and our objective of delivering broad and flexible services to our clients remains our top priority."

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Net new business for our Clinical Research segment for the three months ended June 30, 2019 was $670.7 million, representing a net book-to-bill ratio of 1.24 for the period. This net new business contributed to an ending backlog of $4.5 billion at June 30, 2019.

For the three months ended June 30, 2019, revenue was $763.3 million, which represents growth of 5.6%, or $40.5 million, compared to the three months ended June 30, 2018 at actual foreign exchange rates. On a constant currency basis, revenue grew $49.1 million, an increase of 6.8% compared to the second quarter of 2018. By segment, the Clinical Research segment generated revenues of $702.2 million, while the Data Solutions segment generated revenues of $61.1 million.

Direct costs, exclusive of depreciation and amortization, were $386.2 million during the three months ended June 30, 2019 compared to $381.7 million for the three months ended June 30, 2018 at actual foreign exchange rates. On a constant currency basis, direct costs increased $15.6 million compared to the second quarter of 2018. Consistent with the first quarter of 2019, the increase in direct costs was primarily driven by an increase in labor-related costs in our Clinical Research segment as we continue to hire billable staff to ensure appropriate staffing levels. Direct costs were 50.6% of revenue during the second quarter of 2019 compared to 52.8% of revenue during the second quarter of 2018.

Selling, general and administrative expenses were $98.8 million during the three months ended June 30, 2019 compared to $91.2 million for the three months ended June 30, 2018. Selling, general and

administrative costs were 12.9% of revenue during the second quarter of 2019 compared to 12.6% of revenue during the second quarter of 2018. The increase in selling, general and administrative expenses is primarily related to an increase in salaries and related benefits, including stock-based compensation expense as we continue to hire staff and an increase in office space and related expenses to support our continued growth.

GAAP net income was $41.1 million for the three months ended June 30, 2019, or $0.62 per share on a diluted basis, compared to GAAP net income of $42.0 million for the three months ended June 30, 2018, or $0.64 per share on a diluted basis.

EBITDA was $107.0 million for the three months ended June 30, 2019, representing an increase of 4.3% compared to the three months ended June 30, 2018. Adjusted EBITDA was $129.4 million for the three months ended June 30, 2019, representing growth of 17.9% compared to the three months ended June 30, 2018.

Adjusted net income was $81.8 million for the three months ended June 30, 2019, representing growth of 23.8% compared to the three months ended June 30, 2018. Adjusted net income per diluted share was $1.22 for the three months ended June 30, 2019, representing growth of 22.0% compared to the three months ended June 30, 2018.

A reconciliation of our non-GAAP measures, including EBITDA, adjusted EBITDA, adjusted net income, adjusted net income per diluted share and our 2019 guidance, to the corresponding GAAP measures is included in this press release.

First Half 2019 Financial Highlights

For the six months ended June 30, 2019, revenue was $1,485.3 million, which represents growth of 4.3%, or $60.7 million, compared to the six months ended June 30, 2018 at actual foreign exchange rates. On a constant currency basis, revenue grew $81.4 million, representing growth of 5.7% compared to the six months ended June 30, 2018.

Reported GAAP income from operations was $166.7 million, reported GAAP net income was $85.2 million and reported GAAP net income per diluted share was $1.28 for the six months ended June 30, 2019.

Adjusted Net Income was $155.1 million for the six months ended June 30, 2019, an improvement of 26.8% compared to the same period in 2018. Adjusted Net Income per diluted share was $2.32 for the six months ended June 30, 2019, up 25.4% compared to the same period in 2018.

Guidance

The Company is updating its 2019 revenue guidance to between $3.02 billion and $3.10 billion, representing as reported growth of 5% to 8% and constant currency growth of 6% to 8%. We are updating our GAAP net income per diluted share to between $3.60 and $3.70 and Adjusted Net Income per diluted share to between $4.98 and $5.08, representing growth of 16% to 19%. We continue to estimate our annual effective income tax rate at approximately 24%. Our effective tax rate may differ from this estimate, due to, among other things, changes to estimates of the geographic allocation of our pre-tax income as well as changes in guidance from regulatory agencies related to interpretation, analysis and guidance of the U.S. Tax Cuts and Jobs Act.

Our guidance assumes a EURO rate of 1.15 and a GBP rate of 1.30. All other foreign currency exchange rates are as of June 30, 2019.

Conference Call Details

PRA will host a conference call at 9:00 a.m. ET on August 1, 2019, to discuss the contents of this release and other relevant topics. To participate, please dial (877) 930-8062 within the United States or (253) 336-7647 outside the United States approximately 10 minutes before the scheduled start of the call. The conference ID for the call is 6295812. The conference call will also be accessible, live via audio broadcast, on the Investor Relations section of the PRA website at investor.prahs.com. A replay of the conference call will be available online at investor.prahs.com. In addition, an audio replay of the call will be available for one week following the call and can be accessed by dialing (855) 859-2056 within the United States or (404) 537-3406 outside the United States. The replay ID is 6295812.

Additional Information

A financial supplement with second quarter 2019 results, which should be read in conjunction with this press release, may be found in the Investor Relations section of our website at investor.prahs.com in a document titled "Q2 2019 Earnings Presentation."

On July 31, 2019 Evogene Ltd. (NASDAQ: EVGN) (TASE: EVGN), a leading biotechnology company developing novel products for life science markets, reported its financial results for the second quarter ending June 30, 2019 (Press release, Evogene LTD, JUL 31, 2019, View Source [SID1234537975]).

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Ofer Haviv, Evogene’s President and CEO, stated: "During the first half of 2019 we completed the transition to our new corporate structure consisting of Evogene as a technology hub for multiple subsidiaries in different life-science markets. This corporate structure provides the subsidiaries with support from Evogene, to allow the subsidiaries to focus on building valuable assets and fast-tracking their product development towards commercialization. Evogene’s support to its subsidiaries can be attributed to three main areas:

Access to the CPB platform– right to use the CPB platform by each subsidiary for its dedicated area of activity, to (i) advance subsidiaries’ current product pipelines, (ii) to expand the subsidiaries’ product pipeline.
Corporate and infrastructure support – (i) the subsidiaries’ management works closely with Evogene’s board, management, and advisors to benefit from their broad experience & access to industry network, (ii) Evogene provides access to its facilities and infrastructure including labs, greenhouses, and other.
Funding – Evogene intends to leverage its strong financial position to financially support its subsidiaries until a point of maturity, wherein enough valuable assets have been created to warrant an attractive valuation at fundraising, or through the generation of revenues from sales or collaborations to cover expenses. Evogene aims to remain a major shareholder in its subsidiaries following external fundraising in order to maintain, for Evogene shareholders, a significant share of the subsidiaries’ future profits and/or market value.
Evogene and its subsidiaries are fully committed to achieving the milestones presented in Evogene’s updated corporate presentation filed today." – Mr. Haviv concluded

Recent Developments:

Lavie Bio announced positive 2nd year field results in its bio-stimulant program for wheat with product candidates showing repeated significant yield improvement in spring wheat field trials across multiple locations, varieties and conditions.
Amendment of Evogene’s collaboration agreement with Bayer[1] to include genome editing targets following positive results in corn stalk rot fungal disease control. Evogene will use its CPB platform to identify the required edits to improve disease resistance in corn, focusing on altering gene expression or function. Any promising targets would be pursued by Bayer’s in-house team for validation.
Evogene and certain subsidiary management have initiated a process to evaluate fundraising activities as the opportunities arise.
Consolidated financial results for the period ending June 30, 2019:

Cash position: As of June 30, 2019, Evogene had approximately $46 million in cash, short-term bank deposits and marketable securities, representing a net cash usage of approximately $8.7 million during the first half of 2019 and $4.2 million during the second quarter of 2019.

Assuming that no external financial resources are secured, such as through new collaborations or external fund raising, the Company continues to estimate that its net cash usage in 2019 will be in the range of $16 to $18 million dollars.

Evogene’s consolidated cash use is mostly appropriated to its subsidiaries, mainly Lavie Bio, AgPlenus, and Biomica, with funds also used for the establishment of infrastructure and greenhouses for Canonic.

The Company does not have bank debts.

Revenues primarily consist of research and development payments. These revenues represent R&D cost reimbursement and milestone payments under our various collaboration agreements. The majority of these agreements also provide for royalties or other forms of revenue sharing from successfully developed products.

Gross profit for the first half of 2019 was approximately $0.4 million in comparison to approximately $0.2 million for the first half of 2018. Gross profit for the second quarter of 2019 remained stable at approximately $0.1 million in comparison to the second quarter of 2018.

R&D expenses for the first half of 2019 remained stable at approximately $7 million in comparison to the first half of 2018. R&D expenses for the second quarter of 2019 remained stable at approximately $3.5 million in comparison to the second quarter of 2018. R&D expenses mostly represent product development activities of the Company and its subsidiaries, which include field trials and pre-clinical studies provided by third parties. Evogene’s consolidated R&D expenses were mostly attributed to its subsidiaries, mainly Lavie Bio, AgPlenus, and Biomica, and to its seed division activity.

Operating loss for the first half of 2019 was approximately $9.4 million in comparison to approximately $9.6 million in the first half of 2018. Operating loss for the second quarter of 2019 remained stable at approximately $4.7 million in comparison to the second quarter of 2018.

Net financing income for the first half of 2019 was approximately $1.5 million in comparison to net financing expenses of approximately $0.5 million in the first half of 2018. Net financing income for the second quarter of 2019 was approximately $0.6 million in comparison to net financing expenses of approximately $0.1 million in the second quarter of 2018. This increase in the first half of 2019 is mainly due to translation of Israeli Shekel nominated cash and marketable securities to US Dollars, revaluation of the Company’s marketable securities and interest income on bank deposits.

Loss for the first half of 2019 decreased to approximately to $7.9 million in comparison to a loss of $10.1 million during first half of 2018. Loss for the second quarter of 2019 decreased to approximately to $4.1 million in comparison to a loss of $4.8 million during second quarter of 2018.

Conference Call & Webcast Details:

Evogene’s management will host a conference call today, the 31st of July 2019, to discuss the results at 09:00 AM Eastern time, 16:00 Israel time. To access the conference call, please dial 1-888-668-9141 toll free from the United States, or +972-3-918-0609 internationally. Access to the call will also be available via live webcast through the Company’s website at www.evogene.com.

A replay of the conference call will be available approximately three hours following the completion of the call. To access the replay, please dial 1-888-326-9310 toll free from the United States, or +972-3-925-5904 internationally. The replay will be accessible through August 2, 2019, and an archive of the webcast will be available on the Company’s website through August 11, 2019.