Deciphera Pharmaceuticals, Inc. Announces First Quarter 2018 Financial Results

On May 8, 2018 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, reported financial results for the first quarter ended March 31, 2018, and provided an update on recent clinical and corporate developments (Press release, Deciphera Pharmaceuticals, MAY 8, 2018, View Source [SID1234526229]).

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"Deciphera is off to a strong start in 2018, with data presented at last month’s AACR (Free AACR Whitepaper) Annual Meeting adding to the growing body of research supporting the favorable safety and tolerability profile of DCC-2618, our lead product candidate, and its ability to inhibit a broad range of primary and secondary KIT mutations and primary PDGFRα mutations that arise in drug resistant gastrointestinal stromal tumor patients," said Michael D. Taylor, Ph.D., President and Chief Executive Officer of Deciphera. "We look forward to presenting additional data from the Phase 1 DCC-2618 expansion study throughout the year, including at the upcoming ASCO (Free ASCO Whitepaper) meeting in June. Enrollment in our ongoing Phase 3 INVICTUS study in fourth-line and fourth-line plus GIST is proceeding on track, and we continue to expect the initiation of a second pivotal study in second-line GIST later this year."

Clinical Programs

DCC-2618
Reported preclinical data at the Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in April 2018 demonstrating that compared to the in vitro profiles of the FDA-approved kinase inhibitors imatinib, sunitinib, regorafenib, and midostaurin, and the investigational agent avapritinib (BLU-285), DCC-2618 demonstrated the broadest profile of inhibition of primary and secondary KIT mutations and primary PDGFRα mutations.
The Company also reported updated clinical data at the 2018 AACR (Free AACR Whitepaper) Annual Meeting demonstrating the safety and tolerability profile of DCC-2618 in 100 GIST patients treated at the recommended Phase 2 dose of 150 mg QD, which supports the selection of this dose for the ongoing pivotal, randomized Phase 3 INVICTUS study. As of March 19, 2018, 81 of 137 GIST patients treated at 100 mg or more per day and enrolled as of the cut-off date of January 18, 2018, remained on study. Of these, 46 patients were treated for more than six months, including 10 patients who were treated for more than 12 months.
Enrollment continues in the dose expansion stage of the ongoing Phase 1 clinical trial for DCC-2618 in patients with solid tumors, including GIST and systemic mastocytosis. The Company will present updated data from this clinical trial in a poster presentation and discussion titled "Mutation profile of drug resistant gastrointestinal stromal tumor (GIST) patients (pts) enrolled in the phase 1 study of DCC-2618," at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on Saturday, June 2, 2018 in Chicago, Illinois.
Rebastinib
Investigators at Albert Einstein College of Medicine presented preliminary clinical data at the 2018 AACR (Free AACR Whitepaper) Annual Meeting from their ongoing Phase 1b study with rebastinib, the Company’s selective TIE2 immunokinase inhibitor, in combination with anti-tubulin therapy in patients with metastatic breast cancer. Deciphera is encouraged by the preliminary findings from the investigator-sponsored study and expects to initiate a company-sponsored Phase 1b study with rebastinib later in 2018.
First Quarter 2018 Financial Results

Cash Position: As of March 31, 2018, Deciphera Pharmaceuticals reported cash and cash equivalents of $179.9 million compared to cash and cash equivalents of $196.8 million as of December 31, 2017. This decrease was primarily related to cash used in operating activities.
R&D Expenses: Research and development expenses for the first quarter of 2018 were $16.9 million compared to $5.7 million for the same period in 2017. The increase was primarily due to an increase in spending on the DCC-2618 program of $7.3 million as a result of clinical trial costs related to the ongoing Phase 1 trial and the pivotal Phase 3 INVICTUS study in fourth-line GIST that began enrollment in January 2018. Clinical costs also increased as a result of start-up activities related to the pivotal Phase 3 study in second-line GIST, which is expected to be initiated in the second half of 2018. Manufacturing costs increased for DCC-2618 as a result of new process development to support anticipated greater drug requirements for commercialization as well as the manufacture of registration lots required to support a new drug application. Manufacturing costs for DCC-3014 increased $0.4 million in preparation for our current and planned clinical trials. In addition, personnel related and other costs increased an aggregate of $3.5 million as the result of an increase in costs associated with headcount, early-stage drug discovery programs and consulting fees. Personnel costs for each of the first quarters of 2018 and 2017 included non-cash share-based compensation expense of $1.0 million and $0.1 million, respectively.
G&A Expenses: General and administrative expenses for the first quarter of 2018 were $5.0 million, compared to $2.1 million for the same period in 2017. The increase was primarily due to an increase in legal and professional fees as a result of various advisory fees related to ongoing operations as a public company as well as costs incurred for pre-commercialization activities. In addition, non-cash share-based compensation was $1.1 million and $0.3 million for each of the first quarters of 2018 and 2017, respectively.
Net Loss: For the first quarter of 2018, Deciphera reported a net loss of $21.4 million, or $0.66 per share, compared with a net loss of $7.7 million, or $0.66 per share for the same period in 2017.

Foamix Reports First Quarter 2018 Financial Results and Provides Corporate Update

On May 8, 2018 Foamix Pharmaceuticals Ltd. (NASDAQ:FOMX) ("Foamix" or the "Company"), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical foams to address unmet needs in dermatology,reported financial results for the first quarter ended March 31, 2018 (Press release, Foamix, MAY 8, 2018, View Source [SID1234526228]).

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Clinical and Corporate Update:

• The final patient has been enrolled and dosed in the third Phase 3 study (FX2017-22) investigating FMX101, the Company’s minocycline foam 4%, in patients with moderate-to severe acne.

Top-line results are expected in the third quarter of 2018.
The expected NDA filing for FMX101 is planned for the end of 2018.
• In April 2018, the Company raised aggregate gross proceeds of approximately $16.2 million through a direct registered offering of approximately 2.9 million shares at a price of $5.50 per share to OrbiMed Partners Master Fund Limited.

• On February 14th, 2018, the Company conducted a Type B pre-NDA meeting with the FDA to discuss the submission of a 505(b)(2) application for FMX101.

• In January 2018, the Company announced positive safety data for the Phase 3 open-label safety extension study of FMX101 in moderate-to-severe acne for a treatment period of up to one year.

Details on the open-label study results for FMX101, including efficacy results at 52 weeks, are contained within the most recent Investor Presentation, available on the Company’s website at View Source
Financial Results for the First Quarter Ended March 31, 2018
Revenues
Revenues for the first quarter of 2018 were $906,000, a decrease of $21,000, or 2.3%, from $927,000 in the first quarter of 2017. The decrease is mainly due to a decrease in royalty payments in the amount of $83,000 from Bayer for sales of Finacea Foam.

Operating Expenses
Research and Development Expenses
Research and development expenses for the first quarter were $22.8 million, compared to $12.7 million in the first quarter of 2017. The increase in research and development expenses resulted primarily from an increase of $9.1 million in costs relating predominantly to FMX101 and FMX103 clinical trials and an increase of $634,000 in payroll and payroll-related expenses (including share-based compensation) primarily due to a change in the measurement of share-based compensation expenses of a consultant and the increase in headcount and salary raises.

Selling, General and Administrative Expenses
Selling, general and administrative expenses for the first quarter of 2018 were $3.8 million, compared to $2.8 million in in the first quarter of 2017. The increase in selling, general and administrative expenses resulted primarily from an increase in payroll and other payroll-related expenses (including share-based compensation) mostly due to an increase in headcount, salary raises and accounting modification relating to share-based compensation of a consultant.

Net Loss
For the quarter ended March 31, 2018, the Company recorded a net loss of $26.0 million, or $0.69 per share, basic and diluted, compared with a loss of $14.4 million or $0.39 per share, basic and diluted, for the quarter ended March 31, 2017.

Cash & Cash Equivalents
At March 31, 2018, the Company had $53.1 million in cash and investments compared to $76.4 million at December 31, 2017. Subsequent to the end of the first quarter, the Company raised gross proceeds of $16.2 million in a registered share offering with OrbiMed Partners Master Fund Limited. The Company believes, based on its current business plan, that its existing cash, cash equivalents and marketable securities will fund operating expenses and capital expenditure requirements throughout the completion of its third pivotal Phase 3 clinical trial for its lead product candidate FMX101 and its two pivotal Phase 3 clinical trials for FMX103.

Conference Call & Webcast
Wednesday, May 9 @ 8:30am Eastern Time
Toll Free: 800-289-0438
International: 323-794-2423
Conference ID: 5805126
Webcast: View Source

Replays, Available through May 23:
Toll-Free: 844-512-2921
International: 412-317-6671
Conference ID: 5805126
A replay will also be archived on the Company’s website at www.foamix.com promptly after the conference call.

MediciNova to Present at the UBS Global Healthcare Conference in New York

On May 8, 2018 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number:4875), reported that MediciNova will present a corporate overview at the UBS Global Healthcare Conference on Monday, May 21, 2018 at 9:00 am at the Grand Hyatt New York in New York City (Press release, MediciNova, MAY 8, 2018, View Source;p=RssLanding&cat=news&id=2347957 [SID1234526227]). Yuichi Iwaki, MD, PhD, President and Chief Executive Officer, and Geoffrey O’Brien, JD/MBA, Vice President and Executive Officer, will be available for one-on-one meetings at this conference and investors may request a one-on-one meeting through UBS.

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Navidea Biopharmaceuticals Reports First Quarter 2018 Financial Results

On May 8, 2018 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported its financial results for the first quarter of 2018. Navidea reported total revenues for the quarter of $276,000. Net loss attributable to common stockholders was $6.7 million (Press release, Navidea Biopharmaceuticals, MAY 8, 2018, View Source [SID1234526226]).

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Michael Goldberg, M.D., President and Chief Executive Officer of Navidea, commented, "We were able to advance our core technology on multiple fronts and we experienced a year free from the severe financial constraints the company labored under for over a decade. Navidea had been pursuing a strategy to become a major player in the development and commercialization of precision medicine diagnostic products and took on too much debt to fund the development of in-licensed products and to develop the commercial infrastructure to market and sell its Lymphoseek product. We continue to also drive the process with the FDA and their agents to seek approval of CD206 as a qualified biomarker, thus advancing the use of Tc99m tilmanocept on a broad front for clinical trials. With our best-in-class activated macrophage targeting system, we have been able to generate significant human imaging data and promising animal data with our therapeutic agents, reinforcing our optimism that this platform holds potential for the diagnosis and treatment of diseases in which macrophages play an important role."

First Quarter 2018 Highlights and Subsequent Events

Entered an Amendment to the Asset Purchase Agreement with Cardinal Health 414, LLC ("Cardinal Health 414") in April 2018, pursuant to which Cardinal Health 414 paid the Company approximately $6.0 million and agreed to pay the Company an amount equal to the unused portion of the letter of credit (not to exceed approximately $7.1 million) promptly after the earlier of (i) the expiration of the letter of credit and (ii) the receipt by Cardinal Health 414 of evidence of the return and cancellation of the letter of credit. In exchange, the obligation of Cardinal Health 414 to make any further contingent payments has been eliminated. Cardinal Health 414 is still obligated to make the milestone payments in accordance with the terms of the earnout provisions of the Purchase Agreement.


Presented strong preclinical results in Navidea’s nonalcoholic steatohepatitis ("NASH") research at the 2nd Annual NASH Summit in April


Signed exclusive license with Meilleur Technologies, Inc. a wholly-owned subsidiary of Cerveau Technologies, Inc. to conduct research using NAV4694, as well as an exclusive license for the development and commercialization of NAV4694 in Australia, Canada, China, and Singapore

Completed two clinical imaging studies of intravenous ("IV")-administered Tc99m tilmanocept in subjects with rheumatoid arthritis and results will be included in a package to be submitted to the U.S. Food and Drug Administration ("FDA") regarding a Phase 3 clinical plan

Continued enrollment in IV-administered Tc99m tilmanocept trial in NASH. Enrollment is anticipated to complete by the end of this year.

Continued enrollment in 27-patient Phase 2 cardiovascular clinical study

Completed a preclinical plan for Kaposi’s Sarcoma to be reviewed by the FDA

Initiated a pilot study for imaging Crohn’s Disease with IV-administered Tc99m tilmanocept and evaluation of archival biopsies of Crohn’s patients for CD206 biomarker analysis

Continued series of regular investor-focused Q&A conference calls to improve Investor Relations strategy

Financial Results

Our consolidated balance sheets and statements of operations have been reclassified, as required by current accounting standards, for all periods presented to reflect the line of business sold to Cardinal Health 414 as a discontinued operation. Accordingly, this discussion focuses on describing results of our operations as if we had not operated the discontinued operation during the periods being disclosed.


Total revenues for the first quarter of 2018 were $276,000, compared to $580,000 in the first quarter of 2017. These revenues were primarily grant-related in both periods.


Research and development expenses for the first quarter of 2018 were $999,000, compared to $705,000 in the first quarter of 2017. The net increase was primarily a result of increased NAV4694 development costs due to the 2017 reversal of previously accrued expenses, offset by decreased Tc99m tilmanocept, Manocept, and therapeutics development costs coupled with decreased net compensation costs.


Selling, general and administrative expenses for the first quarter of 2018 were $1.8 million, compared to $3.0 million in the first quarter of 2017. The net decrease was primarily due to decreases in legal and professional services, general office expenses such as insurance, depreciation, rent and travel, and investor relations services.


Navidea’s net loss attributable to common stockholders for the quarter ended March 31, 2018 was $6.7 million, or $0.04 per share (basic), compared to net income attributable to common stockholders of $85.6 million, or $0.53 per share, for the same period in 2017.


Navidea ended the quarter with $2.2 million in cash and investments, not including the accelerated earnout payment of $6.0 million from Cardinal Health 414 which was received after the quarter ended.

Conference Call Details

Investors and the public are invited to access the live audio webcast through the link below. Participants who would like to ask questions during the question and answer session must participate by telephone. Participants are encouraged to log-in and/or dial-in fifteen minutes before the conference call begins.

Event:

Q1 2018 Earnings and Business Update Conference Call

Date:

Wednesday, May 9, 2018

Time:

8:30 am (Eastern Time)

U.S. & Canada Dial-in:

1-929-477-0448

Conference ID:

9493945

Webcast

http://www.audio-webcast.com/cgi-bin/visitors.ssp?fn=visitor&id=5603

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.

Michael Goldberg, M.D., President and Chief Executive Officer of Navidea, commented, "We were able to advance our core technology on multiple fronts and we experienced a year free from the severe financial constraints the company labored under for over a decade. Navidea had been pursuing a strategy to become a major player in the development and commercialization of precision medicine diagnostic products and took on too much debt to fund the development of in-licensed products and to develop the commercial infrastructure to market and sell its Lymphoseek product. We continue to also drive the process with the FDA and their agents to seek approval of CD206 as a qualified biomarker, thus advancing the use of Tc99m tilmanocept on a broad front for clinical trials. With our best-in-class activated macrophage targeting system, we have been able to generate significant human imaging data and promising animal data with our therapeutic agents, reinforcing our optimism that this platform holds potential for the diagnosis and treatment of diseases in which macrophages play an important role."

First Quarter 2018 Highlights and Subsequent Events

Entered an Amendment to the Asset Purchase Agreement with Cardinal Health 414, LLC ("Cardinal Health 414") in April 2018, pursuant to which Cardinal Health 414 paid the Company approximately $6.0 million and agreed to pay the Company an amount equal to the unused portion of the letter of credit (not to exceed approximately $7.1 million) promptly after the earlier of (i) the expiration of the letter of credit and (ii) the receipt by Cardinal Health 414 of evidence of the return and cancellation of the letter of credit. In exchange, the obligation of Cardinal Health 414 to make any further contingent payments has been eliminated. Cardinal Health 414 is still obligated to make the milestone payments in accordance with the terms of the earnout provisions of the Purchase Agreement.

Presented strong preclinical results in Navidea’s nonalcoholic steatohepatitis ("NASH") research at the 2nd Annual NASH Summit in April

Signed exclusive license with Meilleur Technologies, Inc. a wholly-owned subsidiary of Cerveau Technologies, Inc. to conduct research using NAV4694, as well as an exclusive license for the development and commercialization of NAV4694 in Australia, Canada, China, and Singapore

Completed two clinical imaging studies of intravenous ("IV")-administered Tc99m tilmanocept in subjects with rheumatoid arthritis and results will be included in a package to be submitted to the U.S. Food and Drug Administration ("FDA") regarding a Phase 3 clinical plan

Continued enrollment in IV-administered Tc99m tilmanocept trial in NASH. Enrollment is anticipated to complete by the end of this year.

Continued enrollment in 27-patient Phase 2 cardiovascular clinical study

Completed a preclinical plan for Kaposi’s Sarcoma to be reviewed by the FDA


Initiated a pilot study for imaging Crohn’s Disease with IV-administered Tc99m tilmanocept and evaluation of archival biopsies of Crohn’s patients for CD206 biomarker analysis


Continued series of regular investor-focused Q&A conference calls to improve Investor Relations strategy

Financial Results

Our consolidated balance sheets and statements of operations have been reclassified, as required by current accounting standards, for all periods presented to reflect the line of business sold to Cardinal Health 414 as a discontinued operation. Accordingly, this discussion focuses on describing results of our operations as if we had not operated the discontinued operation during the periods being disclosed.

Total revenues for the first quarter of 2018 were $276,000, compared to $580,000 in the first quarter of 2017. These revenues were primarily grant-related in both periods.


Research and development expenses for the first quarter of 2018 were $999,000, compared to $705,000 in the first quarter of 2017. The net increase was primarily a result of increased NAV4694 development costs due to the 2017 reversal of previously accrued expenses, offset by decreased Tc99m tilmanocept, Manocept, and therapeutics development costs coupled with decreased net compensation costs.

Selling, general and administrative expenses for the first quarter of 2018 were $1.8 million, compared to $3.0 million in the first quarter of 2017. The net decrease was primarily due to decreases in legal and professional services, general office expenses such as insurance, depreciation, rent and travel, and investor relations services.

Navidea’s net loss attributable to common stockholders for the quarter ended March 31, 2018 was $6.7 million, or $0.04 per share (basic), compared to net income attributable to common stockholders of $85.6 million, or $0.53 per share, for the same period in 2017.

Navidea ended the quarter with $2.2 million in cash and investments, not including the accelerated earnout payment of $6.0 million from Cardinal Health 414 which was received after the quarter ended.

Conference Call Details

Investors and the public are invited to access the live audio webcast through the link below. Participants who would like to ask questions during the question and answer session must participate by telephone. Participants are encouraged to log-in and/or dial-in fifteen minutes before the conference call begins.

Event:

Q1 2018 Earnings and Business Update Conference Call

Date:

Wednesday, May 9, 2018

Time:

8:30 am (Eastern Time)

U.S. & Canada Dial-in:

1-929-477-0448

Conference ID:

9493945

Webcast

http://www.audio-webcast.com/cgi-bin/visitors.ssp?fn=visitor&id=5603

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website

Aeglea BioTherapeutics Provides Corporate Update and Reports First Quarter 2018 Financial Results

On May 8, 2018 Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company that designs and develops innovative human enzyme therapeutics for patients with rare genetic diseases and cancer, reported financial results for the quarter ended March 31, 2018 (Press release, Aeglea BioTherapeutics, MAY 8, 2018, View Source [SID1234526225]).

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"The first quarter was a terrific start to our year, with a number of positive and encouraging developments in our lead clinical investigational program, pegzilarginase," said Anthony G. Quinn, M.B Ch.B, Ph.D., interim chief executive officer of Aeglea. "I’m excited that we are seeing the first evidence that marked and sustained reductions in plasma arginine with pegzilarginase translated into clinically relevant treatment effects for two patients with Arginase 1 Deficiency. We plan to continue to build on this momentum by reporting additional repeat dose data in patients with Arginase 1 Deficiency in the third quarter of 2018 and finalizing our pivotal study design by the end of the year. In addition, we expect to report topline safety and clinical data from our cancer trials in the fourth quarter of 2018.

"Our April follow-on offering provides us with capital to continue to advance our planned operations and further develop our capabilities as we transition into a pivotal study and start planning for a commercial launch. Our strong cash position and our worldwide commercial rights for pegzilarginase position us favorably to build on recent clinical achievements with investments focusing on accelerating our clinical and pipeline programs."

Corporate Update

Arginase 1 Deficiency:

Aeglea presented initial data that it believes demonstrated clinically relevant treatment effects with pegzilarginase in two Arginase 1 Deficiency patients after only eight weeks of dosing and confirmed the utility of standardized assessment tools in quantifying disease manifestations at the 2018 Annual Clinical Genetics Meeting of the American College of Medical Genetics and Genomics (ACMG) in April. This built upon data presented at the 2018 Annual Meeting of The Society for Inherited Metabolic Disorders (SIMD) that demonstrated pegzilarginase produces marked and sustained reductions in plasma arginine in patients with Arginase 1 Deficiency.
Aeglea expects to report additional pediatric and adult repeat dose data in patients with Arginase 1 Deficiency in the third quarter of 2018.
Cancer:

Aeglea dosed the first patients with pegzilarginase in two small cell lung cancer (SCLC) trials: the single-agent Phase 1 cohort expansion and the Phase 1/2 combination trial with KEYTRUDA, an anti-PD-1 therapy marketed by Merck (known as MSD outside the United States and Canada).
Aeglea presented Phase 1 dose escalation data regarding pegzilarginase in patients with advanced solid tumors at the 2018 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in April.
The Company expects to report topline data, including safety and clinical activity, for the advanced solid tumor cohort expansions and the SCLC combination trial in the fourth quarter of 2018.
Aeglea expects to initiate Phase 2 of its combination trial for patients with SCLC in the third quarter of 2018.
Upcoming Events

Aeglea will participate and provide a corporate update at the UBS Global Healthcare Conference in New York, May 21-23, 2018.

First Quarter 2018 Financial Results

As of March 31, 2018, Aeglea had available cash, cash equivalents and marketable securities of $43.5 million, which excludes approximately $37.7 million in net proceeds from a follow-on public offering which closed on April 23, 2018. Based on Aeglea’s current operating plan, management believes it has sufficient capital resources to fund anticipated operations through the middle of 2020.

Aeglea recognized grant revenues of $1.5 million in the first quarter of 2018, compared with $1.0 million in the first quarter of 2017. The grant revenues were the result of a $19.8 million research grant received from the Cancer Prevention and Research Institute of Texas (CPRIT). The revenue increase was primarily due to higher qualifying expenditures associated with the clinical trials for pegzilarginase in cancer patients in the first quarter of 2018 compared with the first quarter of 2017.

Research and development expenses totaled $6.8 million for the first quarter of 2018, compared with $4.9 million for the first quarter of 2017. The increase was primarily due to expanded clinical activity for Aeglea’s lead product candidate, pegzilarginase, as Aeglea advanced a Phase 1/2 clinical trial in patients with Arginase 1 Deficiency and initiated three single-agent cohort expansions in advanced solid tumor patients and a Phase 1/2 combination trial with KEYTRUDA in patients with small cell lung cancer.

General and administrative expenses totaled $2.8 million for the first quarter of 2018, compared with $2.3 million in the first quarter of 2017. This increase was primarily due to additional employee headcount and compensation costs to further strengthen Aeglea’s management team and support expanding research and development activities.

Net loss totaled $8.1 million and $6.2 million for the first quarter of 2018 and 2017, respectively.

Inducement Grants

Aeglea also announced today that the Compensation Committee of its Board of Directors has granted non-qualified stock options to purchase an aggregate of 21,000 shares of Aeglea’s common stock to three new employees under Aeglea’s 2018 Equity Inducement Plan.

The 2018 Equity Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously an employee or non-employee director of Aeglea (or following a bona fide period of non-employment), as an inducement material to such individual’s entering into employment with Aeglea, pursuant to Rule 5635(c)(4) of the NASDAQ Listing Rules.

The options have an exercise price of $9.76 per share, which is equal to the closing price of Aeglea’s common stock on May 3, 2018. Each of the option awards vests as to 25% of the shares on the one-year anniversary of its grant, with the remainder of the shares vesting ratably over 36 months thereafter