On May 10, 2018 Geron Corporation (Nasdaq:GERN) reported financial results for the first quarter ended March 31, 2018 (Press release, Geron, MAY 10, 2018, View Source [SID1234526544]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

First Quarter 2018 Results

For the first quarter of 2018, the company reported operating revenues of $318,000 and operating expenses of $7.8 million compared to $537,000 and $8.0 million, respectively, for the comparable 2017 period. Net loss for the first quarter of 2018 was $7.2 million, or $0.04 per share, compared to $7.2 million, or $0.05 per share, for the comparable 2017 period.

Revenues for the first quarter of 2018 and 2017 included royalty and license fee revenues under various non-imetelstat license agreements. The company adopted the new revenue recognition accounting standard as of January 1, 2018 using the modified retrospective transition method. Financial results for the first quarter of 2018 are presented under the new accounting standard, but prior period amounts have not been adjusted and continue to be reported under accounting standards used historically. Therefore, there is a lack of comparability to the prior period presented. As a result, the decrease in revenues for the first quarter of 2018 compared to the same period in 2017 reflects not only a reduction in the number of active non-imetelstat license agreements and decreased product sales from licensees, but also a change in the method accounting. However, the company does not expect the adoption of the new revenue recognition accounting standard to have a material impact to its financial statements on an ongoing basis.

Research and development expenses for the three months ended March 31, 2018 and 2017 were $2.4 million and $3.4 million, respectively. The decrease in research and development expenses for the first quarter of 2018 compared to the same period in 2017 primarily reflects reduced personnel related expenses due to lower stock-based compensation expense and lower clinical development expenses under the imetelstat collaboration with Janssen Biotech, Inc. (Janssen).

General and administrative expenses for the three months ended March 31, 2018 and 2017 were $5.3 million and $4.7 million, respectively. The increase in general and administrative expenses for the first quarter of 2018 compared to the same period in 2017 primarily reflects higher consulting and legal costs associated with business development activities.

Interest and other income for the three months ended March 31, 2018 and 2017 was $394,000 and $332,000, respectively. The increase in interest and other income for the first quarter of 2018 compared to the same period in 2017 primarily reflects higher yields on the company’s marketable securities portfolio. For the three months ended March 31, 2018, the company also recognized a loss of $125,000 for the change in the fair value of an equity investment as required under a new accounting standard adopted by the company as of January 1, 2018.

The company ended the first quarter of 2018 with $103.2 million in cash and marketable securities. Subsequently, in April 2018, the company completed the sale of the remaining common stock subject to its At Market Issuance Sales Agreement (Sales Agreement). Under the Sales Agreement, the company sold a cumulative total of approximately 13.8 million shares of common stock and raised net cash proceeds of approximately $48.7 million after deducting sales commissions and offering expenses payable by Geron. No further shares of common stock can be issued under the Sales Agreement. The company expects the net cash proceeds to provide additional capital structure flexibility to potentially support (i) the future development of imetelstat in collaboration with Janssen, if Janssen elects to continue the collaboration, including potentially conducting one or more imetelstat independent development plans (IDPs) under the Collaboration Agreement; (ii) the further development of imetelstat by Geron in the event the collaboration with Janssen does not continue and Geron elects to continue development of imetelstat; or (iii) prospective in-licenses or acquisitions of other oncology products, programs or companies.

"As we have previously announced, we expect Janssen to make its decision about whether to continue their development of imetelstat by the end of third quarter of 2018," said John A. Scarlett, M.D., Geron’s President and Chief Executive Officer. "Regardless of Janssen’s future decision, we believe imetelstat warrants further development because of the activity observed in lower risk MDS patients from Part 1 of IMerge as presented at ASH (Free ASH Whitepaper) last December, and the evolving overall survival in relapsed or refractory MF patients observed in IMbark."

Annual Meeting of Stockholders

Geron’s Annual Meeting of Stockholders will be held at 4:00 p.m. PDT / 7:00 p.m. EDT on May 15, 2018. Further information about the Annual Meeting is available on Geron’s website at www.geron.com on the homepage and in the Investors section under Events.

Due to the proximity of the Annual Meeting, Geron management will not be hosting a separate first quarter conference call

On May 10, 2018 Diplomat Pharmacy, Inc. (NYSE: DPLO) ("Diplomat" or the "Company") reported that its Board of Directors has appointed Brian Griffin, Executive Vice President and CEO of IngenioRx, the pharmacy benefit manager (PBM) of Anthem, Inc. (NYSE: ANTM), as Chief Executive Officer and Chairman of the Board of Directors, effective June 4, 2018 (Press release, Diplomat Speciality Pharmacy, MAY 10, 2018, View Source [SID1234526424]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Ben Wolin, Chairman of the Board, said, "We are pleased to welcome Brian to the Diplomat team at this important time, and are confident that his dynamic skillset and significant industry experience make him ideally suited to assume the roles of CEO and Chairman. Brian is a proven healthcare executive having served in various leadership roles for many years, including at Express Scripts, Empire BlueCross BlueShield and Anthem, most recently launching its PBM organization. He brings expertise in areas essential to Diplomat’s continued growth and success, including a tremendous knowledge of the PBM and specialty pharmacy industries and a deep understanding of the complexities and trends shaping the healthcare environment. His deep experience in Health Plan leadership will be instrumental in leading Diplomat in the rapidly evolving healthcare environment. On behalf of my fellow Board members, we look forward to the next stage of the Company’s growth under Brian’s leadership and are enthusiastic about the opportunities ahead."

As Executive Vice President and CEO for IngenioRx, a role he assumed in March 2018, Mr. Griffin is responsible for building the IngenioRx organization, which will begin offering a full suite of PBM solutions starting in 2020. For the three years prior, Mr. Griffin served as Executive Vice President and President of Anthem’s Commercial and Specialty Business Division. He joined Anthem in 2013 as President and CEO of the company’s second largest affiliated health plan, Empire BlueCross BlueShield, a role he held for two years. From 1987 to August 2012, Mr. Griffin served in positions of increasing responsibility with Medco Health Solutions, Inc., including as President, International and Subsidiaries of Express Scripts International Holding Company, Inc., which completed its merger with Medco Health Solutions, Inc. in April 2012, CEO of Medco International B.V. and CEO of Medco Celesio, B.V. Prior to that, he served as Group President of Health Plans at Medco Health Solutions Inc., and was responsible for national and regional health plans, BlueCross BlueShield plans, commercial insurance carriers, consumer-driven plans and third-party administrators.

Mr. Griffin stated, "This is a time of great opportunity for Diplomat, and I have long admired the Company and its innovative approach to driving better health outcomes. Following years of leadership experience in the healthcare industry, I feel both ready and honored to take on the roles of CEO and Chairman of Diplomat. Together with the Board and management team, I look forward to furthering Diplomat’s growth strategy as we enhance value for shareholders and help enable increased benefits for physicians, pharma, payers and patients."

As previously announced, Atul Kavthekar, in addition to his duties as CFO, has temporarily assumed the role of Interim CEO of Diplomat until Mr. Griffin’s appointment is effective.

With Mr. Griffin’s appointment, the Diplomat Board will expand to eight members. At that time, Mr. Wolin will resume his role and responsibilities as independent Lead Director as outlined in Diplomat’s Corporate Governance Guidelines.

The Diplomat Board retained Ignite Search Partners to assist in the completion of this search process.

Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements give current expectations or forecasts of future events or our future financial or operating performance, and include Diplomat’s expectations regarding the CEO search process. The forward-looking statements contained in this press release are based on management’s good-faith belief and reasonable judgment based on current information. These statements are qualified by important risks and uncertainties, many of which are beyond our control, which could cause our actual results to differ materially from those forecasted or indicated by such forward-looking statements. These risks and uncertainties include CEO succession planning and the dependence on our senior management and key employees, and the additional factors set forth in "Risk Factors" in Diplomat’s Annual Report on Form 10-K for the year ended December 31, 2017 and in subsequent reports filed with or furnished to the Securities and Exchange Commission. Except as may be required by any applicable laws, Diplomat assumes no obligation to publicly update such forward-looking statements, which are made as of the date hereof or the earlier date specified herein, whether as a result of new information, future developments, or otherwise.

On May 10, 2018 Coherus BioSciences, Inc. (Nasdaq:CHRS),reported financial results for the quarter ended March 31, 2018 (Press release, Coherus Biosciences, MAY 10, 2018, View Source/phoenix.zhtml?c=253655&" target="_blank" title="View Source/phoenix.zhtml?c=253655&" rel="nofollow">View Source;p=RssLanding&cat=news&id=2348541 [SID1234526475]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

First Quarter 2018 Corporate Highlights Include:

Oncology therapeutic franchise:

CHS-1701 (pegfilgrastim (Neulasta) biosimilar candidate)
Announced on March 26, 2018, that Judge Stark of the United States District Court for the District of Delaware adopted Magistrate Judge Burke’s Report and Recommendation to grant the motion of Coherus BioSciences, Inc. to dismiss with prejudice the patent infringement complaint alleging infringement of U.S. Patent No. 8,273,707 filed by Amgen Inc.
First Quarter 2018 Financial Results:

Research and development (R&D) expenses for the first quarter of 2018 were $25.5 million compared to $53.8 million for the same period in 2017. The decrease in R&D expenses in the first quarter over the same period in 2017 was mainly due to the completion of our clinical trials for the immunology biosimilar drug candidates, CHS-1420 (adalimumab (Humira) biosimilar) and CHS-0214 (etanercept (Enbrel) biosimilar), and the reprioritization of resources to advance CHS-1701. General and administrative (G&A) expenses for the first quarter of 2018 were $16.6 million, compared to $18.8 million for the same period in 2017. The decrease in G&A expenses in 2018 was mainly attributable to a decrease in personnel and in certain legal and consulting services as a result of cost control steps taken since June 2017. Net loss attributable to Coherus for the first quarter of 2018 was ($44.3) million, or ($0.74) per share, compared to a net loss of ($74.8) million, or ($1.54) per share, for the same period in 2017. Cash and cash equivalents and investments in marketable securities – totaled $95.2 million as of March 31, 2018, compared to $126.9 million as of December 31, 2017.
Guidance for 2018:

CHS-1701 (pegfilgrastim (Neulasta) biosimilar)

Anticipate acceptance of the biologics license application (BLA) on or before June 3, 2018 and a U.S. Food and Drug Administration (FDA) action date of November 3, 2018. Anticipate European approval opinion on or before June 28, 2018. Commercial partnering discussions are projected to continue for certain ex-U.S. territories. Anticipate U.S. commercial launch directly following the potential FDA action date, dependent on regulatory review and approval timing.
CHS-3351 (ranibizumab (Lucentis) biosimilar) and CHS-2020 (aflibercept (Eylea) biosimilar)

Initiate clinical development of CHS-3351. Continue preclinical development of CHS-2020.
CHS-1420 (adalimumab (Humira) biosimilar)

Pursue manufacturing objectives in support of a BLA. Continue to develop partnering options pursuant to a 2022 launch.
Cash flow

Anticipate cash use in operations of approximately $32 to $37 million for the second quarter of 2018.
Conference Call Information

When: Thursday, May 10, 2018 at 4:30 p.m. ET

Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (International)

Conference ID: 2767588

Webcast: View Source

Please join the conference call at least 10 minutes early to register. The webcast will be archived on the Coherus website.

On May 10, 2018 Polaris Group reported that it has signed a multiyear strategic Collaboration Agreement with MD Anderson Cancer Center to utilize its Immunotherapy Platform, led by world-renowned immunotherapy pioneer Dr. James Allison, Dr. Padmanee Sharma, and Dr. Patrick Hwu, to design clinical studies and monitor biomarkers in immune functions associated with the therapies (Press release, Polaris Pharmaceuticals, MAY 10, 2018, View Source [SID1234526491]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

As one of the ten research platforms that support the Cancer Moon Shots ProgramTM, MD Anderson’s Immunotherapy Platform conducts preclinical research to assess feasibility and efficacy of new treatments; it also monitors immune function changes as a result of clinical therapies through cellular and molecular analysis of patient samples in hope of discovering biomarkers for personalized medicine.

"We are very excited to join MD Anderson’s Immunotherapy Platform and be part of its cutting-edge pre-clinical and clinical research programs in the immunotherapy area," said Dr. Bor-Wen Wu, CEO of Polaris Group. "We believe the unique mechanism of action of ADI‑PEG 20 may complement that of the existing immunotherapy drugs, hence potentially achieve higher overall efficacy as combination therapy. We look forward to having a fruitful collaboration on our journey to develop more effective treatments, and the exploration of other immunotherapy targets."

About ADI-PEG 20

ADI‑PEG 20 is a biologic being developed by Polaris Group to treat cancers carrying a major metabolic defect that renders them unable to internally synthesize arginine. Because arginine is essential for protein synthesis and survival of cells, these cancer cells become dependent upon the external supply of arginine to survive and grow. ADI‑PEG 20 is designed to deplete the external supply of arginine, causing arginine-dependent cancer cells to die while leaving the patient’s normal cells unharmed. Multiple cancers have been reported to have a high degree of arginine-dependency and can potentially be treated with ADI‑PEG 20

On May 10,2018 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for cancer, respiratory and other diseases, reported financial results for the first quarter of 2018 ended March 31, 2018, and provided an update on the Company’s recent and future developments (Press release, Pieris Pharmaceuticals, MAY 10, 2018, View Source [SID1234526426]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The first quarter of 2018 was an instrumental one for Pieris, both in advancing our clinical programs and in laying the groundwork for future company growth," said Stephen S. Yoder, President and CEO of Pieris. "We announced a collaboration with Seattle Genetics, strengthening our commitment to building a strong oncology portfolio and forging alliances with other companies on the cutting-edge of cancer research. We also completed an equity raise totaling $47.2 million in net proceeds, allowing for continued value creation through the expansion of our product pipeline and acceleration of IND filings within our immuno-oncology franchise. We are pleased to report that the pace of enrollment for the PRS-343, PRS-060 and PRS-080 trials is healthy, and we are looking forward to reporting data for all three programs in the second half of this year."

PRS-343: Enrollment is progressing on schedule in the Phase I open-label dose-escalation study for PRS-343, a tumor-targeted 4-1BB-based immuno-oncology (IO) bispecific, which the Company initiated in 2017. This program represents the first bispecific T cell costimulatory agonist to enter clinical development. The Company intends to report initial safety, tolerability, pharmacokinetic and pharmacodynamic data from this study in the second half of 2018.

Pieris recently signed an agreement with Roche granting the Company access to atezolizumab (Tecentriq), an approved PD-L1 inhibitor. The plan is to initiate a combination study of PRS-343 plus atezolizumab (Tecentriq) in HER2-positive cancer patients during the second half of 2018.

PRS-060: Pieris continues to enroll healthy subjects in a Phase I first-in-human study for PRS-060, an IL-4 receptor alpha antagonist, which the Company initiated in 2017. PRS-060 is the lead product in the Company’s respiratory alliance with AstraZeneca. Pieris is sponsoring the Phase I clinical program while AstraZeneca is responsible for funding its costs. The Company intends to report initial data from the Phase Ia trial in the fourth quarter of 2018. AstraZeneca will sponsor and continue to fund the development of PRS-060 after completion of a Phase Ib study. Upon completion of a Phase IIa study, Pieris will have separate options to co-develop and co-commercialize PRS-060 with AstraZeneca in the U.S., including the right to field a sales force.

PRS-080: Pieris continues to enroll and treat dialysis-dependent patients with functional iron deficiency anemia in a Phase IIa study for PRS-080, which the Company initiated in 2017. The Company intends to report safety and pharmacodynamic data from this study, including the change in hemoglobin levels after five weekly doses of PRS-080, in the second half of 2018. If data are positive, the Company will seek to partner PRS-080 in territories outside of Japan and other Asian territories for which ASKA Pharmaceutical Co. has an exclusive option.

Board Appointment: In April 2018, Pieris appointed Ann Barbier, M.D., Ph.D., to the Company’s Board of Directors. Dr. Barbier is currently the Chief Medical Officer of Translate Bio.
First Quarter Financial Update:

Cash Position – Cash, cash equivalents and investments totaled $162.2 million as of March 31, 2018, compared to a cash balance of $82.6 million as of December 31, 2017. The increase was driven primarily by the $47.2 million in net proceeds from the Company’s February 2018 equity financing, the $30.0 million in upfront payments received as part of the Seattle Genetics immuno-oncology collaboration, and the $12.5 million milestone payment from AstraZeneca that was triggered during the fourth quarter of 2017 and received during the first quarter of 2018. The increase was partially offset by $11.7 million of operating cash expenditures during the year.

R&D Expense – R&D expenses were $7.9 million for the quarter ended March 31, 2018, compared to $5.4 million for the quarter ended March 31, 2017. The Company’s increase in R&D expenses reflects advancement across its pipeline of programs as well as preparation for and advancement of clinical studies. The increase was partially offset by decreases in our preclinical and manufacturing costs.

G&A Expense – G&A expenses were $4.4 million for the quarter ended March 31, 2018, compared to $4.0 million for the quarter ended March 31, 2017. The Company’s increase in G&A expenses reflects higher personnel, recruiting, and professional services costs. The increase was partially offset by transaction fees for our license and collaboration agreements recorded in the first quarter of 2017.

Net Loss – Net loss was $8.7 million or $(0.17) per share for the quarter ended March 31, 2018, compared to a net loss of $8.0 million or $(0.19) per share for the quarter ended March 31, 2017.

Conference Call:

Pieris management will host a conference call beginning at 8:00 AM Eastern Daylight Time on Thursday, May 10, 2018, to discuss the first quarter of 2018 financial results and provide a corporate update. You can join the call by dialing +1-877-407-8920 (US & Canada) or +1-412-902-1010 (International). An archived replay of the call will be available by dialing +1-877-660-6853 (US & Canada) or +1-201-612-7415 (International) and providing the Conference ID #: 13661472.