Updated Libtayo® (cemiplimab-rwlc) Results Reinforce Durable and Substantial Response Rates in Advanced Cutaneous Squamous Cell Carcinoma

On May 16, 2019 Sanofi and Regeneron Pharmaceuticals, Inc. reported that positive updated data for Libtayo (cemiplimab-rwlc) in locally advanced and metastatic cutaneous squamous cell carcinoma (CSCC) will be shared at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from May 31 to June 4 in Chicago (Press release, Sanofi Genzyme, MAY 16, 2019, View Source [SID1234536428]). Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 and is the first and only treatment approved and available for patients with metastatic CSCC or locally advanced CSCC who are not candidates for curative surgery or curative radiation in the U.S.

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These data from the pivotal Phase 2 EMPOWER-CSCC-1 trial include the primary analysis for the locally advanced CSCC group and longer-term data from the metastatic CSCC group. Together, they provide updated Libtayo efficacy and safety outcomes following its approval by the U.S. Food and Drug Administration (FDA) in September 2018 and will be shared alongside two additional joint Sanofi and Regeneron abstracts on CSCC.

Key data from EMPOWER-CSCC-1 published online in advance of ASCO (Free ASCO Whitepaper) include:

Locally Advanced CSCC

(n=78a)

Metastatic CSCC

(n=59b)

Median follow upa

9 months

(Range: 1 to 28 months)

17 months

(Range: 1 to 27 months)

Overall response rated

(n; 95% confidence interval [CI])

44%

(34; 32%, 55%)

49%

(29; 36%, 63%)

Complete responsed

13% (10)

17% (10)

Partial responsed

31% (24)

32% (19)

Median duration of response (DOR)

Not yet reached

Not yet reached

Median observed time to response

2 months

(Range: 2 to 9 months)

2 months

(Range: 2 to 9 months)

Durable disease control rate (DCR) of ≥16 weekse

63%

(95% CI: 51% to 74%)

63%

(95% CI: 49% to 75%)

Median progression free survival

Not yet reached

18 months

(95% CI: 7 months to not evaluable)

Median overall survival

Not yet reached

Not yet reached

a October 10, 2018 data cutoff

b September 20, 2018 data cutoff

c Excluding survival follow-up

d As assessed by central review

e Durable DCR includes stable disease or response

Among patients with locally advanced CSCC, the most common adverse events (AEs) were fatigue (42%), diarrhea and pruritus (both 27%) and nausea (22%). Grade 3 or higher immune-related AEs occurred in 10% of patients; one patient died due to an unknown cause assessed as treatment-related. Among patients with metastatic CSCC, the most common AEs were diarrhea (29%), fatigue (25%) and nausea (24%). Investigator-assessed Grade 3 or higher immune-related AEs occurred in 14% of patients.

In addition to the EMPOWER-CSCC-1 data, Sanofi and Regeneron are also sharing results from the largest retrospective data set of patients with metastatic or locally advanced CSCC who were treated with chemotherapy or an EGFR (epidermal growth factor receptor) inhibitor but who did not receive anti-PD-1 or anti-PD-L1 therapy.

Sanofi and Regeneron joint presentations at ASCO (Free ASCO Whitepaper) include:

Poster Discussion & Poster Sessions

Primary analysis of Phase 2 results of cemiplimab, a human monoclonal anti-PD-1, in patients with locally advanced cutaneous squamous cell carcinoma (Dr. Michael Migden; Saturday, June 1; Poster Display: 1:15-4:15 PM; Poster Discussion: 4:30-6:00 PM)
Phase 2 study of cemiplimab, a human monoclonal anti-PD-1, in patients with metastatic cutaneous squamous cell carcinoma (mCSCC; Group 1): 12 month follow-up (Dr. Alexander Guminski; Monday, June 3; Poster Display: 1:15-4:15 PM)

Publication-Only Abstracts

Treatment patterns and outcomes among patients with advanced cutaneous squamous cell carcinoma in a US community oncology setting (Dr. C. Lance Cowey; Publication Only)
Patterns of major surgeries among patients diagnosed with cutaneous squamous cell carcinoma (Chieh-I Chen; Publication Only)

Libtayo is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.

About CSCC

CSCC is the second most common type of skin cancer in the world, accounting for approximately 20% of all skin cancers, and the number of newly diagnosed cases is expected to rise substantially in many countries. Although CSCC has a good prognosis when caught early, the cancer can prove especially difficult to treat effectively when it is advanced, and patients can experience reduced quality of life due to the impact of the disease as it progresses. Advanced CSCC is the deadliest non-melanoma skin cancer. While estimates vary, sources suggest that 7,000 people in the U.S. die annually of advanced CSCC.

About Libtayo

Libtayo is approved in the U.S., Canada and Brazil, and under review by the European Commission following a positive opinion by the Committee for Medicinal Products for Human Use (CHMP). In the U.S., Libtayo is approved for the treatment of patients with metastatic CSCC or locally advanced CSCC who are not candidates for curative surgery or curative radiation. The generic name for Libtayo in the U.S. is cemiplimab-rwlc, with rwlc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. FDA.

Libtayo is also being investigated in potential registrational trials in non-small cell lung cancer, basal cell carcinoma and cervical cancer, along with additional trials in squamous cell carcinoma of the head and neck, melanoma, colorectal cancer, prostate cancer, multiple myeloma, Hodgkin’s lymphoma and non-Hodgkin’s lymphoma. These trials are designed to investigate Libtayo as monotherapy; in combination with conventional treatments like chemotherapy; or in combination with other investigational agents, including vaccines, oncolytic viruses and bispecific antibodies, among others. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.

IMPORTANT SAFETY INFORMATION AND INDICATION FOR U.S. PATIENTS

What is the most important information I should know about Libtayo?

Libtayo is a medicine that may treat a type of skin cancer by working with your immune system. Libtayo can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. These problems may happen anytime during treatment or even after your treatment has ended.

Call or see your healthcare provider right away if you develop any symptoms of the following problems or these symptoms get worse:

Lung problems (pneumonitis). Signs and symptoms of pneumonitis may include new or worsening cough, shortness of breath, and chest pain.
Intestinal problems (colitis) that can lead to tears or holes in your intestine. Signs and symptoms of colitis may include diarrhea (loose stools) or more frequent bowel movements than usual; stools that are black, tarry, sticky or that have blood or mucus; and severe stomach-area (abdomen) pain or tenderness.
Liver problems (hepatitis). Signs and symptoms of hepatitis may include yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach area (abdomen), drowsiness, dark urine (tea colored), bleeding or bruising more easily than normal, and feeling less hungry than usual.
Hormone gland problems (especially the adrenal glands, pituitary, thyroid and pancreas). Signs and symptoms that your hormone glands are not working properly may include headaches that will not go away or unusual headaches, rapid heartbeat, increased sweating, extreme tiredness, weight gain or weight loss, dizziness or fainting, feeling more hungry or thirsty than usual, hair loss, feeling cold, constipation, deeper voice, very low blood pressure, urinating more often than usual, nausea or vomiting, stomach-area (abdomen) pain, and changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness.
Kidney problems, including nephritis and kidney failure. Signs of these problems may include decrease in your amount of urine, blood in your urine, swelling in your ankles, and loss of appetite.
Skin problems. Signs of these problems may include rash, itching, skin blistering, and painful sores or ulcers in the mouth, nose, throat, or genital area.
Problems in other organs. Signs of these problems may include headache, tiredness or weakness, sleepiness, changes in heartbeat (such as beating fast, seeming to skip a beat, or a pounding sensation), confusion, fever, muscle weakness, balance problems, nausea, vomiting, stiff neck, memory problems, seizures (encephalitis), swollen lymph nodes, rash or tender lumps on skin, cough, shortness of breath, vision changes, or eye pain (sarcoidosis), seeing or hearing things that are not there (hallucinations), severe muscle weakness, low red blood cells (anemia), bruises on the skin or bleeding, and changes in eyesight.
Rejection of a transplanted organ. Your doctor should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had.
Infusion (IV) reactions that can sometimes be severe and life-threatening. Signs of these problems may include chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, fever, feeling of passing out, back or neck pain, and facial swelling.

Getting medical treatment right away may help keep these problems from becoming more serious.

Your healthcare provider will check you for these problems during your treatment with Libtayo. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may delay or completely stop treatment if you have severe side effects.

Before you receive Libtayo, tell your healthcare provider about all your medical conditions, including if you:

have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus;
have had an organ transplant;
have lung or breathing problems;
have liver or kidney problems;
have diabetes;
are pregnant or plan to become pregnant; Libtayo can harm your unborn baby.
Females who are able to become pregnant:

Your healthcare provider will give you a pregnancy test before you start treatment.
You should use an effective method of birth control during your treatment and for at least 4 months after your last dose of Libtayo. Talk with your healthcare provider about birth control methods that you can use during this time.
Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Libtayo.
are breastfeeding or plan to breastfeed. It is not known if Libtayo passes into your breast milk. Do not breastfeed during treatment and for at least 4 months after the last dose of Libtayo.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of Libtayo include tiredness, rash, and diarrhea. These are not all the possible side effects of Libtayo. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Regeneron Pharmaceuticals and Sanofi at 1-877-542-8296.

Please see accompanying full Prescribing Information, including Medication Guide.

What is Libtayo?

Libtayo is a prescription medicine used to treat people with a type of skin cancer called cutaneous squamous cell carcinoma (CSCC) that has spread or cannot be cured by surgery or radiation.

It is not known if Libtayo is safe and effective in children.

Replimune Announces Poster Presentation at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting

On May 16, 2019 Replimune Group Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported that a trial in progress (TiP) poster will be presented at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held in Chicago, IL from May 31 to June 4, 2019 (Press release, Replimune, MAY 16, 2019, View Source [SID1234536427]). The abstract is available on the ASCO (Free ASCO Whitepaper) website (View Source). The poster will describe the design and current status of the Company’s ongoing Phase 1/2 clinical trial in approximately 150 patients of RP1 alone and in combination with nivolumab anti-PD1 therapy in four solid tumor types, and will be made available on the Company’s website at the time of presentation.

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Details of Replimune’s poster presentation:

Abstract Title: An Open-Label, Multicenter, Phase 1/2 Study of RP1 as a Single Agent and in Combination with PD1 Blockade in Patients with Solid Tumors (Abstract TPS2671)

Session Title: Developmental Immunotherapy and Tumor Immunobiology

Session Date and Time: Saturday June 1st, 8:00am-11:00am CDT

Location: McCormick Place, Exhibit Hall A, Poster Board #301b

About RP1
RP1 is Replimune’s first Immulytic product candidate to enter the clinic and is based on a proprietary new strain of herpes simplex virus engineered to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response.

Oncopeptides Announces Acceptance of Four Abstracts Highlighting Melflufen Clinical Programs for Presentation at 24th EHA Congress in June 2019

On May 16, 2019 Oncopeptides AB (Nasdaq Stockholm: ONCO) reported that a total of four abstracts have been accepted for presentation at the 24th Congress of European Hematology Association (EHA) (Free EHA Whitepaper) meeting (June 13-16, Amsterdam, Netherlands) (Press release, Oncopeptides, MAY 16, 2019, View Source [SID1234536426]).

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Updated data from the Phase 2 HORIZON study evaluating melflufen for the treatment of relapsed/refractory multiple myeloma (RRMM) patients with no or limited remaining treatment options will be presented as an oral presentation by Professor Paul G. Richardson. Three poster presentations, one of which is from the ongoing Phase 1/2 ANCHOR study, will also be presented.

The data in the abstracts regarding the ANCHOR and HORIZON studies is from February 6th 2019 and consequently similar to the data already presented at ASH (Free ASH Whitepaper) 2018. Additional data supporting melflufen’s activity have been generated during the spring of 2019 and will be presented in full at EHA (Free EHA Whitepaper).

CEO
"With the abstracts accepted at EHA (Free EHA Whitepaper), we have now already more than doubled the amount of abstracts accepted for presentations in 2019 compared to the full year of 2018. This underlines the increase in clinical experience that we are generating with melflufen for the treatment of patients with RRMM, and that melflufen continues to show strong activity alone or in combination with other myeloma drugs in this patient population. As always, the abstract book contains quite old data from the ongoing studies and we are excited about the opportunity to present the full data-sets at EHA (Free EHA Whitepaper)", said Jakob Lindberg CEO of Oncopeptides.

Upcoming presentations at EHA (Free EHA Whitepaper)
The HORIZON data will be presented as an oral presentation by Professor Paul G. Richardson, in the session "Novel strategies in multiple myeloma" on June 16 at 08.45 (CET) in the auditorium. Paul G. Richardson, MD, is Professor of Medicine at Harvard Medical School and Clinical Program Leader, Director of Clinical Research at the Jerome Lipper Multiple Myeloma Center Dana-Farber Cancer Institute in Boston, Massachusetts, USA.

The posters will made public presented on Friday, June 14 at 09.30 and presented between 17.30 – 19.00 (CET).

Oncopeptides will also host a symposium at EHA (Free EHA Whitepaper) on June 13th between 18.45 – 20.45 (CET) at the Amsterdam RAI Hall 3B, under the title "Challenging the Treatment Paradigm in Multiple Myeloma".

The four abstracts can be found on the company webpage under:
www.oncopeptides.com / Investors & Media / Presentations / EHA (Free EHA Whitepaper) Abstracts 2019

HORIZON (OP-106): Updated efficacy and safety of melflufen in relapsed / refractory multiple myeloma (RRMM) patients refractory to daratumumab (DARA) and/or pomalidomide (POM)
Topic: Myeloma and other monoclonal gammopathies – Clinical
Session Title: Novel strategies in multiple myeloma
Abstract Code – S 1605

ANCHOR (OP-104): A phase 1/2 study update of melflufen and dexamethasone plus bortezomib or daratumumab in in relapsed / refractory multiple myeloma patients refractory to an IMiD or a proteasome inhibitor
Topic: Myeloma and other monoclonal gammopathies – Clinical
Session Title: Myeloma and other monoclonal gammopathies – Clinical
Abstract Code – 608

O-12-M1: An evaluation of time to next treatment in melflufen and dexamethasone treated patients with relapsed / refractory multiple myeloma
Topic: Myeloma and other monoclonal gammopathies – Clinical
Session Title: Myeloma and other monoclonal gammopathies – Clinical
Abstract Code – PF 628

Tolerability of treatments for relapsed / refractory multiple myeloma: A systematic review
Topic: Quality of life, palliative & supportive care, ethics and health economics
Session Title: Quality of life, palliative & supportive care, ethics and health economics
Abstract Code – PF 726

For further information, please contact:
Jakob Lindberg, CEO of Oncopeptides
E-mail: [email protected]
Telephone: +46 (0)8 615 20 40

Rein Piir, Head of Investor Relations at Oncopeptides
E-mail: [email protected]
Cell phone: +46 (0)70 853 72 92

This information was submitted for publication at 15.00 CET, May 16, 2019.

About melflufen
Melflufen is a lipophilic peptide-conjugated alkylator that rapidly delivers a highly cytotoxic payload into myeloma cells through peptidase activity. It belongs to the novel class Peptidase Enhanced Cytotoxics (PEnC), which is a family of lipophilic peptides that exhibit increased activity via peptidase cleavage and have the potential to treat many cancers. Peptidases play a key role in protein homeostasis and feature in cellular processes such as cell-cycle progression and programmed cell death. Melflufen is rapidly taken up by myeloma cells due to its high lipophilicity and is immediately cleaved by peptidases to deliver an entrapped hydrophilic alkylator payload. In vitro, melflufen is 50-fold more potent in myeloma cells than the alkylator payload itself due to the peptidase cleavage, and induces irreversible DNA damage and apoptosis. Melflufen displays cytotoxic activity against myeloma cell lines resistant to other treatments, including alkylators, and has also demonstrated inhibition of DNA repair induction and angiogenesis in preclinical studies.

Oncolytics Biotech (R) Publishes Abstract Highlighting Additional Biomarker Analyses at the 2019 American Society of Clinical Oncology Annual Meeting

On May 16, 2019 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported the publication of an abstract highlighting additional immune-based biomarker data used to help predict patient response to pelareorep in combination with checkpoint inhibitor therapy (Press release, Oncolytics Biotech, MAY 16, 2019, View Source [SID1234536425]). The abstract was published online as part of the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in the Meeting Proceedings, an online supplement of ASCO (Free ASCO Whitepaper)’s Journal of Clinical Oncology.

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The abstract, titled, "Prediction of response to pelareorep plus pembrolizumab in pancreatic ductal adenocarcinoma (PDAC)," describes further immune analysis of the peripheral blood of patients from REO 024, a completed phase 1b study of pelareorep and Keytruda (pembrolizumab) in combination with chemotherapy in patients with advanced (second-line) pancreatic cancer. A phase 2 trial of pelareorep plus pembrolizumab in advanced PDAC is currently ongoing.

"The gene expression and cytokine data analysis, as well as TCR-sequencing, provides further insight into the immune environment prior to and during treatment with pelareorep and pembrolizumab," said Dr. Rita Laeufle, Chief Medical Officer of Oncolytics Biotech. "These additional findings further highlight pelareorep’s ability to create an inflamed phenotype, resulting in a primed immune system that we believe supports combination treatment with immune checkpoint inhibitors. It also builds on our discovery that T cell clonality can serve as a predictive and prognostic biomarker for clinical benefit when used to identify patients who may respond well to this therapeutic combination. This new biomarker data supports the potential selection of patients in future clinical studies, giving these studies a higher likelihood of success."

Key data and conclusions:

•Clonal T cell diversity was expanded during therapy, broadening the potential repertoire of T cells that can target tumor cells.
•~30% of expanded clones at day eight of pelareorep therapy were durable after one cycle of treatment suggesting a refinement of T cell clones that target the best tumor cell antigens.
•Gene expression analysis in peripheral blood mononuclear cells (PBMCs) helps to validate the changes in T cell diversity, where responding patients had higher levels of pro-inflammatory cytokines expressed by activated T cells, compared to non-responders. Importantly, there was a statistically significant upregulation of genes that aid in the recruitment and activation of T cells including IL17F, CCL7, and ICOS (raw p < 0.05).
•Gene expression analysis in PBMCs may serve as a separate and independent biomarker, and helps to corroborate our previously published blood-based T cell clonality biomarker for pelareorep therapy.

The abstract was authored by Dr. Christos Fountzilas, Assistant Professor, Dept. of Medicine – GI Medical Oncology, Roswell Park Comprehensive Cancer Center and his colleagues, in collaboration with Oncolytics Biotech, Northwestern University, UT Health San Antonio, and Adaptive Biotechnologies. The publication of the abstract can be found on the Posters & Publications page of Oncolytics’ website, View Source

About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

NGM Bio Reports Recent Highlights and First Quarter 2019 Financial Results

On May 16, 2019 NGM Biopharmaceuticals, Inc. (Nasdaq: NGM), a clinical stage biotechnology company focused on developing transformative therapeutics for patients, reported first quarter 2019 financial results for the period ending March 31, 2019 (Press release, NGM Biopharmaceuticals, MAY 16, 2019, View Source [SID1234536424]).

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"We’ve had a productive 2019 thus far, making progress on multiple fronts, including the initiation of a Phase 2b clinical trial evaluating NGM282 in patients with non-alcoholic steatohepatitis (NASH) and F2-F3 liver fibrosis," said David J. Woodhouse, Ph.D., chief executive officer of NGM. "Bolstered by the successful completion of our IPO in April and a strong cash position, we continue to advance our broad clinical and preclinical pipeline of next generation medicines. We look forward to sharing further developments regarding these programs later this year."

First Quarter 2019 and Recent Highlights

Completed Initial Public Offering (IPO) and concurrent private placement with Merck. The company’s common stock commenced trading on the Nasdaq Global Select Market under the ticker symbol "NGM" on April 4, 2019. The IPO, priced at a public offering price of $16.00 per share, raised $111.9 million in aggregate net proceeds, including shares sold to the underwriters pursuant to the partial exercise of their overallotment option and after deducting the underwriting discounts and commissions. The company received $65.9 million in additional proceeds from a concurrent private placement of shares of common stock to Merck Sharp & Dohme Corp. (Merck) at the IPO public offering price of $16.00 per share.

Dosed first patient in Phase 2b ALPINE 2/3 clinical study in NASH patients with F2-F3 fibrosis for NGM282. The Phase 2b ALPINE 2/3 study is expected to enroll approximately 150 patients with biopsy-confirmed NASH and stage F2-F3 liver fibrosis, and will assess the efficacy, safety and tolerability of NGM282 compared to placebo. The primary efficacy objective is to evaluate the treatment effect after 24 weeks of three dose levels of NGM282 (0.3 mg, 1 mg and 3 mg) on liver histology, which is defined as an improvement in liver fibrosis (³ 1 stage change) with no worsening of NASH or a resolution of NASH (defined as a NAFLD activity score for inflammation of 0 or 1 and ballooning score of 0) with no worsening of fibrosis. NGM anticipates announcing preliminary results from this Phase 2b clinical study in 2020.

Extended strategic collaboration with Merck. In March, Merck exercised its option to extend its broad, strategic collaboration with NGM for an additional two-year period from March 2020 to March 2022. During the two-year extension period, Merck will continue to fund NGM’s research and development efforts at the same levels as the original collaboration terms and, in lieu of a $20 million extension fee payable to NGM, Merck will make additional payments totaling $20 million in support of NGM’s research and development activities during 2021 and the first quarter of 2022. The companies also announced that Merck will terminate its license to NGM’s growth differentiation factor 15 (GDF15) receptor agonist program, effective May 31, 2019, at which time the program rights will return to NGM.

Appointed Hsiao D. Lieu, M.D., as Senior Vice President, Chief Medical Officer. In March, NGM announced the appointment of Hsiao D. Lieu, M.D. as Senior Vice President, Chief Medical Officer. Dr. Lieu most recently served as Vice President of Early Clinical Development at Genentech, where he was responsible for early phase drug development for all non-oncology indications, including ophthalmology, metabolic, neurology and inflammation. Concurrent with Dr. Lieu’s appointment, Alex DePaoli, M.D., who had served as NGM’s founding Chief Medical Officer, transitioned to the role of Senior Vice President, Chief Translational Officer. In this new role, Dr. DePaoli is focused on guiding NGM’s robust discovery portfolio into clinical development.

First Quarter Financial Results

Related party revenue for the first quarter of 2019 was $25.6 million compared to $18.6 million for the same period in 2018.

Research and development expenses for the first quarter of 2019 were $29.5 million, as compared to $19.5 million for the same period in 2018. The increase in research and development expense was primarily related to an increase in external research and development expenses associated with the advancement of NGM’s growing pipeline and increased NGM282 program expenses due to the ongoing Phase 2 clinical trials.

General and administrative expenses for the first quarter 2019 were $5.4 million, as compared to $3.9 million for the same period in 2018. The increase in general and administrative expenses was primarily attributable to personnel-related expenses and an increase in legal and professional service expenses required to support NGM’s ongoing operations.

For the first quarter of 2019, NGM reported a net loss of $8.3 million, compared to a net loss of $3.9 million for the same period in 2018.

Cash, cash equivalents and short-term marketable securities were $193.4 million as of March 31, 2019, which does not include the net proceeds from NGM’s initial public offering and the private placement of shares with Merck, which closed in April, compared to $206.6 million as of December 31, 2018.