On May 14, 2018 ERYTECH Pharma (Euronext: ERYP – Nasdaq: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported its financial results for the quarter ended March 31, 2018 (Press release, ERYtech Pharma, MAY 14, 2018, View Source [SID1234526581]).

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"Following our successful Nasdaq listing at the end of last year, the first quarter of this year has been focused on the execution of the plan to advance our pipeline into solid tumor indications," said Gil Beyen, chief executive officer at ERYTECH. "Set up activities are on track for the launch of a pivotal Phase 3 trial in second line pancreatic cancer and a Phase 2 trial in first line triple-negative breast cancer. We are expanding our teams and increasing our manufacturing capacity in Europe and the U.S. Furthermore, we will meet with the FDA to discuss our ALL program and await the CHMP’s feedback on our MAA submission for relapsed and refractory ALL. We look forward to providing updates later this year."

Business Highlights

Feedback was obtained from the Commission for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) on the design of the proposed Phase 3 trial with eryaspase in second line pancreatic cancer, confirming earlier feedback by the U.S. Food and Drug Administration (FDA). The proposed Phase 3 trial will evaluate eryaspase in combination with standard chemotherapy, compared to standard chemotherapy alone, in approximately 500 patients in the United States and Europe. The primary endpoint will be overall survival (OS). An interim analysis is foreseen when approximately two-thirds of events have occurred. Set up activities for this pivotal Phase 3 clinical trial are ongoing. Enrollment of the first patient is expected in the third quarter of 2018.
Metastatic triple-negative breast cancer (TNBC) was selected as the next solid tumor indication for the development of eryaspase. TNBC is an aggressive and metabolically active form of breast cancer for which limited treatment options are available. The planned proof of concept Phase 2 trial will evaluate eryaspase in combination with standard chemotherapy, compared to standard chemotherapy alone, in approximately 60 previously untreated patients in Europe and the United States. An interim analysis is foreseen. The primary endpoint will be objective response rate. Set up activities are ongoing and start of patient enrollment is expected in the third quarter of 2018.
ERYTECH is planning to expand the clinical development of eryaspase to first-line pancreatic cancer, as well as to other solid tumor indications. Program updates are expected later in 2018 and early 2019.
Full results from the U.S. Phase 1 trial evaluating eryaspase in combination with chemotherapy for the treatment of first line adult ALL were presented at the annual meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper). The data showed eryaspase was well tolerated. Based on the pharmaco-kinetic data and the safety findings, the recommended dose for further clinical development was determined to be 100 U/kg. A meeting with the FDA to discuss the next steps in ALL in the United States is upcoming, based on which we expect to be able to provide feedback during the third quarter of 2018.
Additionally, the Company also presented pre-clinical data on the combination of eryaspase and erymethionase, methionine-gamma-lyase encapsulated in red blood cells. The data in this study suggested that this combination could be promising in vitro and in vivo in a gastric cancer model with tumor growth inhibition in-vivo and decreased tumor cell viability in vitro.
Earlier today, the Company announced the expansion of its executive management team with the addition of Alex Dusek as VP of Commercial Strategy, to lay the groundwork for commercial success and ensure commercial product preparedness, primarily in the U.S. He brings over 25 years of experience including commercial strategic roles at Argos Therapeutics, Bayer, and United Therapeutics.
Financial Highlights

Net loss for the three-month period ended March 31, 2018 was €11.7 million, compared to €6.5 million in the same period of 2017. The €5.2 million increase was primarily attributable to:
An increase in R&D expenses by €1.9 million, related to the Company’s intensified clinical and regulatory activities, as well as the additional staffing for preclinical research and clinical development.
An increase in G&A expenses by €0.8 million, resulting from continued infrastructure developments in line with the Company’s growth.
The accounting of a €2.5 million financial loss, as the Company’s cash position denominated in euros was impacted by the negative currency exchange variation in the period of the U.S. dollar against the euro.
As of March 31, 2018, ERYTECH had cash and cash equivalents totaling €171.8 million, compared with €185.5 million as of December 31, 2017. The €13.8 million decrease in total cash and cash equivalents in the three-month period comprised a total net cash utilization of €11.2 million for operating, investing and financing activities, and a €2.6 million negative foreign exchange impact on the Company’s cash position denominated in U.S. dollars. This financial accounting loss had no real cash impact, as the U.S. dollar position is kept in that currency for U.S. dollar disbursements.
Key Upcoming Milestones Expected in 2018

Meeting with the FDA to discuss next steps in ALL
Launch of a pivotal Phase 3 clinical trial in second-line pancreatic cancer in Europe and the United States
Launch of a Phase 2 proof-of-concept clinical trial in TNBC
CHMP opinion on MAA resubmission for GRASPA in R/R ALL
Initiation of a Phase 2 proof-of-concept clinical trial in first-line pancreatic cancer
Initiation of Phase 1 clinical trial with erymethionase
First Quarter Results 2018 Conference Call Details

As a reminder, ERYTECH management will hold a conference call and webcast on Tuesday, May 15th, 2018 at 02:30pm CET / 08:30am EDT to discuss business highlights and financial results for the first quarter of 2018. Gil Beyen, Chairman and CEO, Eric Soyer, CFO and COO and Iman El-Hariry, CMO will deliver a brief presentation, followed by a Q&A session.

The call is accessible via the below teleconferencing numbers, followed by the Conference ID#: 3498017#

USA/Canada: +1 833 818 6807

United-Kingdom: +44 2031070289

Switzerland: +41 445802606

Germany: +49 6922224728

France: +33 176748988

Belgium: +32 24003547

Sweden: +46 856619361

Finland: +358 972519310

Netherlands: +31 207075547

Spain: +34 914142503

The webcast can be followed live online via the link: View Source

An archived replay of the call will be available for 7 days by dialing + 1 800 585 8367, Conference ID: 3498017#

An archive of the webcast will be available on ERYTECH’s website, under the "Investors" section at investors.erytech.com

2018 Financial Calendar:

General Assembly Meeting of Shareholders: Friday, June 22, 2018 at 10:00am CET in Paris
Quarterly financial updates:
Business Update and Financial Highlights for the 2nd quarter and first-half of 2018: September 17, 2018 (after U.S. market close), followed by a conference call and webcast on September 18, 2018 (2:30pm CET/8:30am ET)
Business Update and Financial Highlights for the 3rd quarter of 2018: November 12, 2018 (after U.S. market close), followed by a conference call and webcast on November 13, 2018 (2:30pm CET/8:30am ET)
Upcoming Investor Conferences:

BioEquity Europe 2018, May 16, Ghent
Gilbert Dupont Annual Healthcare Conference, May 29, Paris
Jefferies 2018 Global Healthcare Conference, June 5-6, New York
Journée Valeurs Moyennes SFAF, June 20, Paris
JMP Life Sciences Conference, June 20, New York
European Midcap Event – Spring, June 26-27, Paris

On May 14, 2018 Agilent Technologies, Inc. (NYSE: A) reported revenue of $1.21 billion for the second quarter ended April 30, 2018, up 9 percent year over year (up 4.3 percent on a core basis(1)) (Press release, Agilent, MAY 14, 2018, http://www.agilent.com/about/newsroom/presrel/2018/14may-gp18040.html [SID1234526808]).

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Second-quarter GAAP net income was $205 million, or $0.63 per share. Last year’s second-quarter GAAP net income was $164 million, or $0.50 per share.

During the second quarter, Agilent had intangible amortization of $25 million, business exit and divestitures of $8 million, transformational initiatives of $5 million, acquisition and integration costs of $4 million, and $11 million in other net gains. Excluding these items and a tax benefit of $24 million, Agilent reported second-quarter non-GAAP net income of $212 million, or $0.65 per share(2).

"Again this quarter, we delivered significant earnings and cash flow growth on strong top-line results, contributing to an excellent first half of 2018. We saw strength in the Pharma and Chemical & Energy markets with 8 percent and 5 percent growth this quarter, respectively," said Mike McMullen, Agilent CEO and president.

"We are successfully executing on our growth strategy," continued McMullen. "On the innovation front, we are seeing strong momentum in our newly released products and are continuing to introduce highly differentiated solutions to help our customers advance their work. We are also effectively deploying our capital—the recently closed acquisitions of Genohm and Lasergen, Inc. will add new strategic capabilities to drive future growth and create value for our customers and our shareholders."

Second-quarter revenue of $561 million from Agilent’s Life Sciences and Applied Markets Group (LSAG) grew 7 percent year over year (up 3 percent on a core basis(1)). Strength in mass spectrometry and cell analysis led the results. LSAG’s operating margin for the quarter was 21.2 percent.

Second-quarter revenue of $426 million from the Agilent CrossLab Group (ACG) grew 13 percent year over year (up 7 percent on a core basis(1)). Growth was strong across services and consumables. ACG’s operating margin for the quarter was 23.1 percent.

Second-quarter revenue of $219 million from Agilent’s Diagnostics and Genomics Group (DGG) grew 9 percent year over year (up 4 percent on a core basis(1)) led by strength in genomics. DGG’s operating margin for the quarter was 20.2 percent.

Agilent expects third-quarter 2018 revenue in the range of $1.185 billion to $1.205 billion. Third-quarter 2018 non-GAAP earnings are expected to be in the range of $0.61 to $0.63 per share(3).

For fiscal year 2018, revenue guidance of $4.850 billion to $4.870 billion is adjusted only for changes in currency. Core revenue growth of 5.5 percent at the midpoint of guidance remains unchanged. Agilent expects non-GAAP earnings of $2.63 to $2.67 per share(3). The guidance is based on April 30, 2018 currency exchange rates.

Conference Call

Agilent’s management will present more details about its second-quarter fiscal 2018 financial results on a conference call with investors today at 1:30 p.m. (Pacific Time). This event will be webcast live in listen-only mode. Listeners may log on at www.investor.agilent.com and select "Q2 2018 Agilent Technologies Inc. Earnings Conference Call" in the "News & Events — Calendar of Events" section. The webcast will remain available on the company’s website for 90 days.

Additional information regarding financial results can be found at www.investor.agilent.com by selecting "Financial Results" in the "Financial Information" section.

A telephone replay of the conference call will be available at approximately May 14, 2018 at 4:30 PM (Pacific Time) after the call and through May 21 by dialing +1 855-859-2056 (or +1 404-537-3406 from outside the United States) and entering pass code 7398497.

The adjustment for taxes excludes tax benefits that management believes are not directly related to on-going operations and which are either isolated or cannot be expected to occur again with any regularity or predictability. For the three and six months ended April 30, 2018, management uses a non-GAAP effective tax rate of 18.0%. In the same periods last year, management used a non-GAAP effective tax rate of 19.0%.
(b) GAAP diluted net loss per share was computed using 323 million weighted average diluted shares which excludes from consideration the anti-dilutive effects of all potential common shares outstanding.
(c) Non-GAAP diluted net income per share was computed using 326 million weighted average diluted shares which includes the dilutive effects of potential common shares outstanding.

We provide non-GAAP net income and non-GAAP net income per share amounts in order to provide meaningful supplemental information regarding our operational performance and our prospects for the future. These supplemental measures exclude, among other things, charges related to amortization of intangibles, transformational initiatives, acquisition and integration costs, pension settlement gain, NASD site costs, special compliance costs, and adjustment for Tax Reform.

Business exit and divestiture costs include costs associated with business divestitures.

Transformational initiatives include expenses associated with targeted cost reduction activities such as manufacturing transfers, small site consolidations, legal entity and other business reorganizations, insourcing or outsourcing of activities. Such costs may include move and relocation costs, one-time termination benefits and other one-time reorganization costs. Included in this category are also expenses associated with company programs to transform our product lifecycle management (PLM) system, human resources and financial systems.

Acquisition and Integration costs include all incremental expenses incurred to effect a business combination. Such acquisition costs may include advisory, legal, accounting, valuation, and other professional or consulting fees. Such integration costs may include expenses directly related to integration of business and facility operations, the transfer of assets and intellectual property, information technology systems and infrastructure and other employee-related costs.

Pension settlement gain resulted from transfer of the substitutional portion of our Japanese pension plan to the government.

NASD site costs include all the costs related to the expansion of our manufacturing of nucleic acid active pharmaceutical ingredients incurred prior to the commencement of commercial manufacturing.

Special compliance costs include costs associated with transforming our processes to implement new regulations such as the EU’s General Data Protection Regulation (GDPR), revenue recognition and certain tax reporting requirements.

Other includes certain legal costs and settlements in addition to other miscellaneous adjustments.

Adjustment for Tax Reform primarily consists of an estimated provision of $480 million for U.S. transition tax and correlative items on deemed repatriated earnings of non-U.S. subsidiaries and an estimated provision of $53 million associated with the decrease in the U.S. corporate tax rate from 35% to 21% and its impact on our U.S. deferred tax assets and liabilities. The taxes payable associated with the transition tax, net of tax attributes, on deemed repatriation of foreign earnings is approximately $440 million, payable over 8 years. The final impact of Tax Reform may differ materially from these estimates, due to, among other things, changes in interpretations, analysis and assumptions made, additional guidance that may be issued, and actions that we may undertake.

Our management uses non-GAAP measures to evaluate the performance of our core businesses, to estimate future core performance and to compensate employees. Since management finds this measure to be useful, we believe that our investors benefit from seeing our results "through the eyes" of management in addition to seeing our GAAP results. This information facilitates our management’s internal comparisons to our historical operating results as well as to the operating results of our competitors.

Our management recognizes that items such as amortization of intangibles can have a material impact on our cash flows and/or our net income. Our GAAP financial statements including our statement of cash flows portray those effects. Although we believe it is useful for investors to see core performance free of special items, investors should understand that the excluded items are actual expenses that may impact the cash available to us for other uses. To gain a complete picture of all effects on the company’s profit and loss from any and all events, management does (and investors should) rely upon the GAAP income statement. The non-GAAP numbers focus instead upon the core business of the company, which is only a subset, albeit a critical one, of the company’s performance.

Readers are reminded that non-GAAP numbers are merely a supplement to, and not a replacement for, GAAP financial measures. They should be read in conjunction with the GAAP financial measures. It should be noted as well that our non-GAAP information may be different from the non-GAAP information provided by other companies.

Income from operations reflect the results of our reportable segments under Agilent’s management reporting system which are not necessarily in conformity with GAAP financial measures. Income from operations of our reporting segments exclude, among other things, charges related to amortization of intangibles, business exit and divestiture costs, transformational initiatives, acquisition and integration costs, NASD site costs, and special compliance costs.

Readers are reminded that non-GAAP numbers are merely a supplement to, and not a replacement for, GAAP financial measures. They should be read in conjunction with the GAAP financial measures. It should be noted as well that our non-GAAP information may be different from the non-GAAP information provided by other companies.

We compare the year-over-year change in revenue excluding the effect of recent acquisitions and divestitures and foreign currency rate fluctuations to assess the performance of our underlying business.

(a) The constant currency year-over-year growth percentage is calculated by recalculating all periods in the comparison period at the foreign currency exchange rates used for accounting during the last month of the current quarter, and then using those revised values to calculate the year-over-year percentage change.

(b) The dollar impact from the current quarter currency impact is equal to the total year-over-year dollar change less the constant currency year-over-year change.

The preliminary reconciliation of GAAP revenue adjusted for recent acquisitions and divestitures and impact of currency is estimated based on our current information.

BioXcel Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, BioXcel Therapeutics, 2018, MAY 14, 2018, View Source [SID1234527534]).

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Mersana Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Mersana Therapeutics, 2018, MAY 14, 2018, View Source [SID1234527574]).

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On May 14, 2018 Atossa Genetics Inc. (NASDAQ:ATOS), a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions, reported First Quarter ended March 31, 2018 financial results and provided an update on recent company developments (Press release, Atossa Genetics, MAY 14, 2018, View Source [SID1234526558]).

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Steve Quay, President and CEO, commented, "During the first part of 2018, we have continued to make significant advances driving toward the next phase of our clinical plans – including a new program in men’s breast health and receiving regulatory approval to commence our Phase 2 breast density study in Sweden. We are especially excited about engaging additional experts that will advise us on important initiatives including seeking partners in the pharmaceutical industry to accelerate the clinical development of our Endoxifen programs. This quarter, we plan to complete our Phase 1 study of topical Endoxifen in men, commence enrollment in our Phase 2 study of topical Endoxifen in women with mammographic breast density, and open our Phase 2 study of oral Endoxifen in women who are "refractory" to tamoxifen."

Recent Corporate Developments

Atossa’s important recent developments include the following:

May 2018 – Formed strategic advisory board to accelerate growth with prominent former pharmaceutical executives from Pfizer and Boehringer Ingelheim.
April 2018 – Received approval from the Swedish Medical Products Agency (MPA) to conduct a Phase 2 Study of proprietary topical Endoxifen for the treatment of women with mammographic breast density.
April 2018 – Received a positive interim safety review on the Phase 1 study of topical Endoxifen in men, which is being developed to address gynecomastia (or male breast enlargement).
April 2018 – Announced a reverse split of common stock at a ratio of 1-for-12 that was effective on April 20, 2018 and which led to regaining compliance with Nasdaq.
March 2018 – Announced that Per Hall, MD, Ph.D., Head of the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet in Stockholm, Sweden had been appointed as Scientific Advisor.
March 2018 – Expanded the breast health program by launching a men’s’ breast health initiative with enrollment opening in a Phase 1 study of the proprietary topical Endoxifen in men.
February 2018 – Announced important additional findings from the Phase 1 study of Atossa’s proprietary oral Endoxifen.
Q1 2018 Financial Results

We generated no revenue or cost of revenue for the three months ended March 2018. Currently we are in the research and development phase and do not market any products and services.

The Company recorded a net loss of $1.9 million for the three months ended March 31, 2018. Total operating expenses were approximately $1.9 million for the three months ended March 31, 2018, consisting of general and administrative (G&A) expenses of approximately $1.4 million, and research and development (R&D) expenses of approximately $0.5 million. Total operating expenses were approximately $1.7 million for the three months ended March 31, 2017, consisting of G&A expense of approximately $1.2 million and R&D expenses of $0.5 million.