On May 10, 2018 RXi Pharmaceuticals Corporation (NASDAQ: RXII) a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (sd-rxRNA) therapeutic platform reported its financial results for the first quarter ended March 31, 2018 and provided a business update (Press release, RXi Pharmaceuticals, MAY 10, 2018, View Source [SID1234526427]).

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"With the bulk of the clinical activities for our Dermatology and Ophthalmology studies behind us, we expect in the next 2 to 3 quarters to reduce our cash burn per quarter by $0.5 million – or about 20% – from $2.5 million to about $2 million," said Dr. Geert Cauwenbergh, President and CEO of RXi Pharmaceuticals. He further added that, "The final review of the results of our Phase 2 clinical study with Samcyprone in cutaneous warts is almost complete, and these study results will be presented as a poster during the upcoming International Investigative Dermatology meeting on May 18, 2018. We expect that the availability of this clinical data will be helpful in the partnering outreach for our dermatology franchise, and we expect to start the formal partnering process in the next few weeks. Against the back-drop of several partnerships in IO and ACT that we have already announced and expect to expand even further in the current quarter, we feel that RXi is set for some exciting events in the coming few months."

The Company will host a conference call today at 4:30 p.m. EDT to discuss financial results and provide an update on the Company. The webcast link will be available under the "Investors – Event Calendar" section of the Company’s website, www.rxipharma.com. The event may also be accessed by dialing toll-free in the United States and Canada: +1 844-376-4678. International participants may access the event by dialing: +1 209-905-5958. An archive of the webcast will be available on the Company’s website approximately two hours after the presentation.

Select First Quarter 2018 Financial Highlights

Cash Position

At March 31, 2018, the Company had cash of $2.6 million as compared with $3.6 million at December 31, 2017.

On August 8, 2017, the Company entered into a purchase agreement with Lincoln Park Capital Fund, LLC ("LPC"), pursuant to which the Company has the right to sell to LPC up to $15 million in shares of the Company’s common stock, subject to certain limitations and conditions set forth therein, over the 30-month term of the purchase agreement. The Company has sold a total of 420,000 shares of common stock to LPC for net proceeds of approximately $1.4 million under the purchase agreement.

On April 9, 2018, the Company entered into a securities purchase agreement with certain institutional and accredited investors relating to the offering and sale of 1,510,604 shares of the Company’s common stock at a purchase price of $3.15 per share (the "Offering"). Concurrently with the Offering, the Company also commenced a private placement, whereby it issued and sold warrants exercisable for a total of 1,132,953 shares of common stock, which represents 75% of the shares of common stock sold in the Offering, with a purchase price per share of $0.125 per underlying warrant share and with an exercise price of $3.15 per share (the "Private Placement"). Assuming the warrants are not exercised, net proceeds to the Company from the Offering and Private Placement were approximately $4.1 million after deducting placement agent fees and estimated Offering and Private Placement expenses.

Revenues

Revenues for the quarter ended March 31, 2018 were $23,000 and related to the work performed by the Company as a sub-awardee under the government grant awarded to our collaborator BioAxone Biosciences, Inc. from the National Institute of Neurological Disorders and Stroke. The Company had no revenues during the quarter ended March 31, 2017.

Research and Development Expenses

Research and development expenses for the quarter ended March 31, 2018 were $1.4 million, as compared with $1.3 million for the quarter ended March 31, 2017. The increase was primarily due to increases in lab supply purchases and manufacturing fees for the Company’s immuno-oncology program.

Acquired In-process Research and Development Expense

The Company did not have acquired in-process research and development expense for the quarter ended March 31, 2018. The Company recorded $4.6 million of acquired in-process research and development expense for the acquisition of MirImmune Inc. during the quarter ended March 31, 2017. The expense related to the fair value of consideration given in the acquisition of MirImmune, which included transaction costs, liabilities assumed and cancellation of notes receivable, and the deferred tax impact of the acquisition.

General and Administrative Expenses

General and administrative expense for the quarter ended March 31, 2018 was $0.9 million, as compared with $1.1 million for the quarter ended March 31, 2017. The decrease was primarily due to decreases in professional fees for legal-related services and payroll-related expenses as a result of a decrease in headcount.

Income Tax

There was no income tax expense or benefit during the three months ended March 31, 2018. For the three months ended March 31, 2017, the Company recognized an income tax benefit of $1,621,000 due to the tax-related impact of the Company’s acquisition of MirImmune in January 2017.

Net Loss

Net loss for the quarter ended March 31, 2018 was $2.2 million, compared with $5.5 million for the quarter ended March 31, 2017. The decrease was primarily due to in-process research and development expense and income tax benefit recorded during the prior year quarter related to the Company’s acquisition of MirImmune, as discussed above.

Select First Quarter 2018 and Recent Corporate Highlights

Select Business and Corporate Highlights

Immuno-Oncology

On April 16, 2018, the Company announced that research conducted using its self-delivering RNAi platform in the field of immunotherapy to treat cancer was published in Molecular Therapy, a leading peer-reviewed journal.

In this paper, scientists demonstrate the potential of improving therapy with patient-derived tumor infiltrating lymphocytes (TILs) by treating with RXi’s novel sd-rxRNA compound which specifically targets PD-1. Targeting the PD-1/PD-L1 axis can enhance the ex vivo expansion rate and in vivo longevity and functionality of these T-cells and thereby have the potential to improve Adoptive Cell Therapy (ACT) outcomes in cancer patients. The sd-rxRNA compounds are based on the proprietary therapeutic platform developed and owned by RXi Pharmaceuticals and are ideally suited to reprogram immune cells used in various forms of ACT.

"Self-Delivering RNAi (sd-rxRNA) Targeting PD-1 using Adoptive Cell Therapy Approach for the Treatment of Malignant Melanoma" may be accessed on Molecular Therapy’s website:
View Source(18)30172-2

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]).

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"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.

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]).

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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 Eagle Pharmaceuticals, Inc. ("Eagle" or "the Company") (Nasdaq: EGRX) reported its financial results for the three months ended March 31, 2018 (Press release, Eagle Pharmaceuticals, MAY 10, 2018, View Source [SID1234526420]). Highlights of and subsequent to the first quarter of 2018 include:

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Business and Recent Highlights:

Eagle requested final U.S. Food and Drug Administration (FDA) approval for its tentatively approved ready-to-dilute bendamustine hydrochloride 500ml solution; launch to be scheduled upon approval;
RYANODEX for EHS clinical trial planned for August 17 – 23, 2018 during the Hajj pilgrimage;
Eagle’s vasopressin injection 1ml abbreviated new drug application (ANDA) accepted for filing by the FDA in April 2018; Eagle believes it is first-to-file;
Eagle continued to advance RYANODEX in the treatment of nerve agent exposure; Eagle expects to meet again shortly with officials from the U.S. Military to formalize the clinical and regulatory plans;
Oral arguments in the litigation to resolve Eagle’s orphan drug exclusivity for BENDEKA were held in Washington D.C. on May 4, 2018;
United States Patent and Trademark Office issued a third patent (9,925,263) in the Eagle Biologics family of patents in March 2018; and
Eagle completed enrollment in the fulvestrant clinical study in February 2018 with study results anticipated in the fall of 2018.
Financial Highlights:

First Quarter 2018

Total revenue for the first quarter of 2018 was $46.6 million, compared to $76.8 million in the first quarter of 2017 (which included $25.0 million in license and other income);
Q1 2018 income before income tax provision was $1.7 million compared to $32.7 million in Q1 2017;
Q1 2018 net income was $2.6 million, or $0.18 per basic and $0.17 per diluted share, compared to net income of $22.9 million, or $1.50 per basic and $1.42 per diluted share in Q1 2017;
Q1 2018 Adjusted Non-GAAP net income was $8.2 million, or $0.55 per basic and $0.53 per diluted share, compared to Adjusted Non-GAAP net income of $26.5 million, or $1.74 per basic and $1.64 per diluted share in Q1 2017;
During Q1 2018, Eagle purchased an additional $7 million of Eagle common stock as part of its share buyback program; since August 2016, Eagle has repurchased $88 million of Eagle common stock;
Settled $48 million in potential Arsia milestone obligations in exchange for $15 million in cash; and
Cash and cash equivalents were $95.7 million, accounts receivable was $53.4 million, and debt was $48.8 million as of March 31, 2018.
Reiterating 2018 Expense Guidance:
R&D expense is expected to be in the range of $46 – $50 million ($40 – $44 million on a non-GAAP basis)
SG&A expense is expected to be in the range of $61 – $64 million ($44 – $47 million on a non-GAAP basis)
"We expect multiple catalysts to drive growth and build long-term value at Eagle. This includes expanding our existing bendamustine and RYANODEX portfolios by taking advantage of product and label expansion opportunities, as well as protecting the franchises with our robust patent estate and exclusivity. We believe that advancing several of our late-stage opportunities targeting attractive new markets will open additional paths for growth and profitability for years to come," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

"We have decided to launch our tentatively approved bendamustine hydrochloride 500ml solution, subject to receipt of final approval from the FDA, which we have recently requested. We believe that we are uniquely positioned to fill a need with the segment of the population that requires an alternative to TREANDA, but at a lower price point to BENDEKA. Over time, this would provide us with more control over our revenue growth and allow us to better manage our business. We continue to believe BENDEKA is a tremendous product with many patient and caregiver benefits. Teva is doing a very good job for us and we are pleased with their accomplishments. We view the launch of a "big bag" formulation as complementary, enabling us to provide additional value to a cost-conscious segment of the market, while at the same time allowing Eagle to increase profitability," added Tarriff.

"We also look forward to advancing RYANODEX for EHS with another clinical study at the Hajj in August of this year, adding to the positive data we have already collected. Our fulvestrant study is now fully underway with results anticipated later this year. In addition, with what we believe is a first-to-file ANDA submission for vasopressin accepted for filing, as well as our progress on a second ANDA product, we are excited about these added opportunities to create value for patients and shareholders," concluded Tarriff.

First Quarter 2018 Financial Results

Total revenue for the three months ended March 31, 2018 was $46.6 million, as compared to $76.8 million for the three months ended March 31, 2017 (which included a $25 million milestone payment from Teva).

Research and development expenses increased to $17.3 million for the first quarter of 2018, compared to $7.5 million in the first quarter of 2017, largely due to external clinical costs associated with the fulvestrant clinical study, which completed randomization of 600 subjects during the first quarter of 2018. Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense during the first quarter of 2018 was $15.0 million.

SG&A expenses decreased to $15.2 million in the first quarter of 2018 compared to $18.6 million in the first quarter of 2017. The decrease was due to the expiration of the Spectrum co-promotion agreement at the end of June 2017, as well as a reduction in marketing expenses. These reductions were partially offset by the increase in personnel-related expenses associated with the expansion of our sales force during the second quarter of 2017. Excluding stock-based compensation and other non-cash and non-recurring items, first quarter 2018 SG&A expense was $10.5 million.

Net income for the first quarter of 2018 was $2.6 million, or $0.18 per basic and $0.17 per diluted share, compared to net income of $22.9 million, or $1.50 per basic and $1.42 per diluted share in the three months ended March 31, 2017, due to the factors discussed above.

Adjusted Non-GAAP net income for the first quarter of 2018 was $8.2 million, or $0.55 per basic and $0.53 per diluted share, compared to Adjusted Non-GAAP net income of $26.5 million or $1.74 per basic and $1.64 per diluted share in the first quarter of 2017. For a full reconciliation of Adjusted Non-GAAP net income to the most comparable GAAP financial measures, please see the tables at the end of this press release.

Liquidity

As of March 31, 2018, the Company had $95.7 million in cash and cash equivalents and $53.4 million in net accounts receivable, $42 million of which was due from Teva. The Company had $48.8 million in outstanding debt.

We purchased $7 million of Eagle common stock as part of our expanded $100 million share buyback program. Since August 2016, we have repurchased $88 million of our common stock. During the first quarter of 2018, we paid $15 million in cash to settle the Arsia milestones.

2018 Expense Guidance

2018 R&D expense is expected to be in the range of $46 – $50 million. This reflects ongoing expenses for (i) the enrollment of fulvestrant and RYANODEX for EHS clinical trials; (ii) API outlays for the fulvestrant and vasopressin programs; and (iii) additional preclinical assays for the RYANODEX nerve agent program. Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense is expected to be in the range of $40 – $44 million.

2018 SG&A expense is expected to be in the range of $61 – $64 million. Excluding stock-based compensation and other non-cash and non-recurring items, SG&A expense is expected to be in the range of $44 – $47 million.

On May 10,2018 Sierra Oncology, Inc. (Nasdaq: SRRA), a clinical stage drug development company focused on advancing next generation DNA Damage Response (DDR) therapeutics for the treatment of patients with cancer, reported its financial and operational results for the first quarter ended March 31, 2018 (Press release, Sierra Oncology, MAY 10, 2018, View Source [SID1234526417]).

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"In late February 2018, we provided a comprehensive update on the development program for our Checkpoint kinase 1 (Chk1) inhibitor, SRA737. We also announced planned amendments to our SRA737 Monotherapy Phase 1/2 trial that are now being implemented, which include expanding the overall size of the trial and adding a sixth cohort targeting CCNE1-driven high grade serous ovarian cancer (HGSOC). This cohort is of high interest to us given mounting evidence for the role that CCNE1 amplification has in driving replication stress in cancer and the corresponding reliance on Chk1 in order to manage this replication stress. Analogous to poly ADP-ribose polymerase (PARP) inhibitors, which first exhibited robust activity in patients harboring BRCA mutations, emerging evidence suggests that Chk1 inhibitors such as SRA737 may prove effective in defined genetic backgrounds of high replication stress, such as CCNE1 amplification," said Dr. Nick Glover, President and CEO of Sierra Oncology. "We are also pleased to report that we have advanced our Phase 1/2 Low-Dose Gemcitabine Combination trial into the Cohort Expansion Phase 2 portion, which is targeting enrollment of 80 genetically-selected patients across four indications, with a comparable biological orientation based on both exogenous (low-dose gemcitabine) and intrinsic genetic drivers of replication stress. An update from this trial and preliminary data from the Monotherapy trial are anticipated in the fourth quarter of 2018."

During the first quarter, Sierra reported signing a supply agreement with Janssen Research & Development, LLC pursuant to which they will supply TESARO’s ZEJULA (niraparib), an orally administered PARP inhibitor, facilitating the initiation of a combination trial of niraparib with SRA737 in patients with prostate cancer in the fourth quarter of 2018. The trial is to be led by Professor Johann de Bono, Regius Professor of Cancer Research, Head of the Division of Clinical Studies and Professor in Experimental Cancer Medicine at The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust.

Subsequent to the end of the quarter, Sierra presented preclinical results for SRA737, including late-breaking data, in two posters at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) 2018 Annual Meeting, demonstrating that SRA737 has anti-tumor activity across a broad range of settings, including as monotherapy in aggressive CCNE1-driven HGSOC patient-derived xenografts and in combination with a PARP inhibitor in tumor cells that have acquired resistance to PARP inhibitors and/or platinum therapy.

Sierra is also currently designing a clinical study evaluating SRA737 in combination with immuno-oncology agents, which potentially could be submitted to regulatory authorities in the fourth quarter of 2018.

In addition to SRA737, Sierra is also advancing SRA141, a potent, selective, orally bioavailable small molecule inhibitor of cell division cycle 7 kinase (Cdc7). SRA141 is currently undergoing preclinical research in preparation for an Investigational New Drug Application (IND) submission to the U.S. Food and Drug Administration (FDA) expected in the second half of 2018.

First Quarter 2018 Financial Results (all amounts reported in U.S. currency)
Research and development expenses were $8.3 million for the first quarter of 2018, compared to $8.0 million for the first quarter of 2017. The increase was primarily due to an increase of $1.7 million in clinical trial costs partially offset by decreases of $0.9 million in third-party manufacturing costs related to SRA737 and SRA141, and $0.5 million in research, preclinical and other support costs. Research and development expenses included non-cash stock-based compensation of $1.0 million for both the first quarter of 2018 and of 2017.

General and administrative expenses were $3.4 million for the first quarter of 2018, compared to $3.1 million for the first quarter of 2017. This increase was primarily due to an increase in personnel-related costs and professional fees. General and administrative expenses included non-cash stock-based compensation of $0.5 million for both the first quarter of 2018 and of 2017.

Net loss was $11.5 million for the first quarter of 2018, compared with a net loss of $11.1 million for the first quarter of 2017.

Cash and cash equivalents totaled $133.8 million as of March 31, 2018, compared to $100.3 million as of December 31, 2017. This increase was due to an underwritten public offering of 21,850,000 shares of common stock in March 2018, pursuant to which the company raised net proceeds of $46.0 million, net of underwriting discounts, commissions and offering expenses. The company believes that its existing cash and cash equivalents will be sufficient to fund current operating plans through approximately mid-2020. At March 31, 2018, there were 74,309,681 shares of common stock issued and outstanding and stock options to purchase 10,202,831 shares of common stock issued and outstanding.