On March 2, 2020 Veracyte, Inc., (Nasdaq: VCYT) reported the publication of a large, retrospective study in which the Danish Breast Cancer Group (DBCG) used the Prosigna breast cancer prognostic gene signature assay to identify which women were more likely to benefit from aggressive chemotherapy based on their intrinsic breast cancer subtype (Press release, Veracyte, MAR 2, 2020, View Source [SID1234555046]). The findings appear online in npj Breast Cancer, a peer-reviewed open-source journal, and suggest that women with HER2-enriched subtypes may benefit from commonly used anthracycline-containing chemotherapy regimens, while those with luminal breast cancer subtypes – which accounted for 30 percent of the women in the study – could potentially be spared such treatment regimens, which have significant cardiotoxicity in some patients.

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The findings are from a retrospective analysis of the DBCG89D trial – a prospectively designed, randomized trial of 980 pre- and post-menopausal Danish women with early-stage breast cancer who were administered adjuvant chemotherapy regimens that contained anthracycline (epirubicin) or were CMF- (cyclophosphamide, methotrexate and fluorouracil) based. Among the 686 women with Prosigna results, overall survival was significantly different in anthracycline- versus non-anthracycline treated patients with HER2-enriched (Hazard Ratio of 0.72, 95% Confidence Interval 0.52; 0.99) tumors, but not in patients with luminal A (Hazard Ratio of 1.62, 95% Confidence Interval 0.97; 2.71) or luminal B (Hazard Ratio of 1.41, 95% Confidence Interval 0.80; 2.47) cancers. Of the 686 women with Prosigna results, the test identified 132 women with luminal A, 78 with luminal B, 259 with basal-like and 217 with HER2-enriched breast cancer subtypes.

"Our study was a carefully planned, formal re-analysis of an important Danish clinical trial that helped establish the use of anthracycline chemotherapies in breast cancer — an aggressive treatment that saves lives but can have serious side effects, including heart damage," said Torsten Nielsen, M.D., Ph.D., professor of pathology and laboratory medicine at BC Cancer, the University of British Columbia, a co-author of the study and a developer of the gene signature on which the Prosigna test is based.

"By applying Prosigna technology, which had not yet been invented when the tumor tissue from this trial was originally collected and stored, we found that patients with luminal subtypes did not benefit from putting anthracycline drugs into the chemotherapy regimen. These drugs only provided added benefit to those with non-luminal molecular subtypes. The study contributes to the accumulating body of evidence that the breast cancer molecular subtypes and risk scores identified with Prosigna technology can help identify which women can safely back off of aggressive chemotherapy."

The Prosigna test uses advanced genomic technology to inform next steps for patients with early-stage breast cancer, based on the genomic make-up of their disease. The test analyzes the activity of 50 genes known as the PAM50 gene signature, along with clinical-pathological features, and can provide a hormone-receptor positive early breast cancer patient and her physician with a prognostic score indicating the probability of cancer recurrence during the next 10 years. Outside of the United States, it is also utilized to provide PAM50 molecular subtype information.

"These new data suggest that the Prosigna test may be able to offer new levels of individualized treatment for women with early-stage breast cancer, potentially enabling many to avoid more aggressive chemotherapy regimens," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "These findings also suggest exciting future expansion opportunities for the Prosigna test’s positioning in global markets where intrinsic breast cancer subtypes are reported in the test results."

Veracyte acquired the Prosigna test from NanoString Technologies, Inc. in December 2019 as part of its acquisition of the exclusive global diagnostic rights to the nCounter FLEX Analysis System. The DBCG retrospective study was supported by funds from NanoString Technologies.

About the Prosigna Breast Cancer Prognostic Gene Signature Assay

Physicians use Prosigna to help guide therapeutic decisions so that patients receive therapeutic interventions, such as chemotherapy, only if clinically warranted. The in vitro diagnostic test is indicated in female breast cancer patients who have undergone surgery in conjunction with locoregional treatment consistent with standard of care, either as:

A prognostic indicator for distant recurrence‐free survival at ten years in post‐menopausal women with Hormone Receptor‐Positive (HR+), lymph node‐negative, Stage I or II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors; or
A prognostic indicator for distant recurrence‐free survival at ten years in post‐menopausal women with Hormone Receptor‐Positive (HR+), lymph node‐positive (1‐3 positive nodes), Stage II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors. The device is not intended for patients with 4 or more positive nodes.
The Prosigna test is FDA 510(k) cleared in the United States for use on the nCounter Dx Analysis System and is available for use when ordered by a physician. The test is performed on formalin-fixed and paraffin-embedded tissue. The Prosigna test has been CE-marked, showing that it conforms with European Union regulations, and is available for use by healthcare professionals in the European Union and other countries that recognize the CE mark, as well as in Canada, Israel, Australia, New Zealand and Hong Kong. The test is covered by Medicare and leading private payers in the United States and is widely covered by government and private payers in the countries where it is available.

On March 2, 2020 Immunocore, a pioneering, clinical-stage T cell receptor biotechnology company working to develop and commercialize a new generation of transformative medicines to address unmet needs in cancer, infection and autoimmune disease, reported the completion of its Series B private financing round, generating more than $130 million (Press release, Immunocore, MAR 2, 2020, View Source [SID1234555045]).

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Immunocore’s Series B round is led by General Atlantic, a leading global growth equity firm and new investor in Immunocore. Other new investors participating in this round include CCB International, JDRF T1D Fund, Rock Springs Capital, Terra Magnum Capital Partners and WuXi AppTec’s Corporate Venture Fund. Five existing shareholders in the Company, including Eli Lilly and Company and RTW Investments, are also participating, as well as the Bill & Melinda Gates Foundation through conversion of its outstanding loan note.

The proceeds will enable Immunocore to further expand and accelerate its rapidly growing clinical stage pipeline of ImmTAX (Immune mobilising monoclonal TCRs Against Cancer, Infectious Diseases and Autoimmune) molecules that includes three oncology programs in MAGE-A4 (in collaboration with Genentech), NYESO-1 (in collaboration with GSK), and the lead program tebentafusp (IMCgp100), which is in pivotal clinical studies as a potential treatment for patients with metastatic uveal melanoma.

The proceeds will allow the company to advance two wholly owned clinical-stage internal programs for chronic Hepatitis B and for PRAME, a target expressed in a wide range of tumors. This investment is also expected to accelerate Immunocore’s novel platform to treat autoimmunity, including type one diabetes (in collaboration with the JDRF T1D Fund), advance the TCR platform and expand its database of rich and novel targets.

Bahija Jallal, Ph.D., Chief Executive Officer and Director of Immunocore, commented: "We are extremely pleased that General Atlantic is leading our Series B round and welcome them, along with our new investors, to Immunocore. This new funding – from an international cadre of health care investors joined by some of our existing shareholders – represents a further endorsement of our unique and powerful platform technology, our novel class of TCR-based biologic therapies, the accomplished scientists at Immunocore and our mission to transform the lives of people with serious diseases."

Rob Perez, Operating Partner, General Atlantic, said: "We are pleased to partner with Immunocore at this key time in its development, with lead candidate tebentafusp on the cusp of commercialization and two further assets in the clinic. We are excited by the broad applicability of the science within the Company’s ImmTAX platform and the Company’s promising pipeline across oncology, infectious and autoimmune diseases. We look forward to providing impactful support to Immunocore as it continues on its strong growth trajectory."

On March 2, 2020 Marker Therapeutics, Inc. (NASDAQ:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported that the Company has entered into a Common Stock Purchase Agreement (the "Agreement") of up to $30 million with Aspire Capital Fund, LLC ("Aspire"), a Chicago-based institutional investor and long-term Marker shareholder (Press release, TapImmune, MAR 2, 2020, View Source [SID1234555044]).

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Under the terms of the Agreement, Aspire has committed to purchase up to $30 million of the Company’s common stock at Marker’s discretion from time to time during a 30-month period at prices based on the market price at the time of each sale. Marker will retain full control as to the timing and amount of any sale of shares of common stock to Aspire, subject to certain limitations specified in the Agreement.

There are no warrants, options, financing swaps, derivatives or other securities associated with this Agreement. Additionally, there are no financial covenants or restrictions on future financings and there are no rights of first refusal, participation rights, penalties or liquidated damages. Lastly, Marker maintains the right to terminate the Agreement at any time, at its discretion, without any additional cost or penalty. Proceeds from the Agreement will be used to further advance the Company’s pipeline including its post-transplant acute myeloid leukemia (AML) Phase 2 trial, which is expected to begin in 2020, as well as for general corporate purposes.

"This Agreement with Aspire provides Marker with the opportunity to access capital in an efficient manner," stated Peter L. Hoang, President and CEO of Marker. "The financial flexibility provided by this transaction will further support the advancement of our clinical programs including the first Marker-sponsored clinical trial this year investigating our novel MultiTAA cell therapy."

As consideration for Aspire’s entering into the Agreement, Marker issued 345,357 shares to Aspire as a commitment fee. Additional detail regarding the Agreement is set forth in Marker’s Current Report on Form 8-K, filed today with the SEC.

On March 2, 2020 Primmune Therapeutics reported that it has raised $7 million in seed financing to support the development of novel orally-administered, small molecule toll-like receptor 7 (TLR7) agonists for long-term systemic activation of innate immunity (Press release, Primmune Therapeutics, MAR 2, 2020, View Source [SID1234555043]). Investors in the seed financing were CAM Capital, Charlie McDermott, BioBrit and BioRock Ventures.

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In conjunction with the financing, Scott Morenstein, Managing Director at CAM Capital will join the board of directors. Ezra Cohen, M.D., Chief, Division of Hematology-Oncology and Associate Director, Translational Science, Moores Cancer Center at the University of California, San Diego and Isan Chen, M.D., Chief Medical and Development Officer at Mirati Therapeutics will join the company’s clinical advisory board.

"The recent advances in cancer immunotherapy have resulted in medicines that have had profound benefit for cancer patients; yet, a majority of those patients do not respond or relapse. There is a strong rationale for combining agents that activate systemic innate immunity, like a TLR7 agonist, with drugs that engage systemic adaptive immunity, like checkpoint inhibitors, to potentially address patients who have an inadequate response to approved treatments," said Charlie McDermott, Chief Executive Officer of Primmune Therapeutics. "We are pleased to have secured financial support from our investors and local biotech executives who are committed to supporting the advancement of our small molecule TLR7 agonists into human studies in oncology and virology."

Primmune is being led by an experienced and dedicated team, which includes:

• Charlie McDermott, Chairman, President & Chief Executive Officer
• James Appleman, Ph.D., Co-founder, Board Member, SVP, R&D and Chief Scientific Officer
• Paulo Rangel, President, Co-founder, Board Member, Chief Business Officer
• Stephen Webber, Ph.D., Co-founder and SVP Medicinal Chemistry
• Todd Harris, Ph.D., Board Member, CEO of Tyra Biosciences

Mr. McDermott is Chairman, President & CEO of Primmune. He brings more than 25 years of experience in the life sciences industry and has held roles of increasing responsibility in drug discovery, regulatory affairs, corporate development, commercial planning, and executive management. Most recently, Mr. McDermott was President, Chief Business Officer, and a member of the board of directors of Impact Biomedicines, Inc. While at Impact, Mr. McDermott raised more than $110 million in venture and non-dilutive royalty financing to fully fund the development and commercialization of fedratinib (INREBIC) for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF). Impact was acquired by Celgene in 2018 for $1.1 billion upfront and up to $7 billion overall, if all contingent payments are realized. Prior to joining Impact, Mr. McDermott was President and Chief Business Officer of Kala Pharmaceuticals, Inc., where he helped lead the transformation of Kala from a private pre-clinical stage company to a pre-commercial stage public company. To this end, Mr. McDermott helped raise approximately $190 million via private equity, debt, and an initial public offering. In August of 2018, Kala received NDA approval for Inveltys, an internally developed drug for ocular indications. Before joining Kala, Mr. McDermott worked at Allergan as Vice President, Global Business Development for the Eye Care and Drug Delivery business units. At Allergan, Mr. McDermott led efforts to license and acquire a variety of technologies and therapeutics including Lastacaft, Acuvail, Restasis MultiDose, Latisse, and Abicipar. Before joining Allergan, Mr. McDermott held positions as Associate Director of Business Development at deCODE genetics and before that, in drug discovery and regulatory affairs at Pfizer/Agouron. Mr. McDermott has an M.A. in molecular, cellular, and developmental biology from University of California, Santa Barbara, an MBA from the University of San Diego and a B.A. in biochemistry and molecular biology from the University of California, Santa Cruz.

Dr. Appleman is SVP, R&D and CSO, Co-founder, Director of Primmune. Dr. Appleman brings nearly 30 years of experience in building successful drug discovery organizations while having served as an advisor to biotech, hi-tech, and diagnostic firms. Dr. Appleman is a Co-founder of eFFECTOR Therapeutics where he established both the technology base and bioinformatics infrastructure to support eFFECTOR’s unique programs targeting dysregulated mRNA translation. He previously served as Senior Vice President, Research and Chief Scientific Officer at Anadys Pharmaceuticals, Inc. where he played a pivotal role in the business process culminating in the acquisition of Anadys for $230M (256% premium to market cap) by Roche. Additionally, he led the invention, characterization and clinical development of the Anadys’ internally discovered drug candidates setrobuvir and ANA773, a novel oral TLR7 agonist for the treatment of cancer and hepatic viral diseases. Prior to joining Anadys, Dr. Appleman held positions at Gensia, Inc. and its subsidiary Metabasis Therapeutics and was a faculty member at St. Jude Children’s Research Hospital. He received a Ph.D. in biochemistry from Oklahoma State University and completed his postdoctoral training at Dartmouth Medical School.

Mr. Rangel is Chief Business Officer, Co-founder, Director of Primmune. He brings 25 years of experience in the pharmaceutical and related industries in both small and large companies. Before Primmune, Mr. Rangel was President & CEO and Co-founder of Evince Biosciences, a precursor to Primmune Therapeutics. Before Evince, Mr. Rangel was a Partner at ProPharma Partners International, an international consulting group where he focused on working with biopharmaceutical and medical device companies on worldwide in- and out- licensing, valuations, business plans and market research. Before ProPharma, Mr. Rangel was Head of Global Business Development at Besins Healthcare, a global pharmaceutical company with products targeted at women’s and men’s health. Mr. Rangel was a founder of, and key executive in, two medical device start-ups, Lasercure Sciences and 5i Sciences (now Sommetrics). In those positions, he managed the financing, clinical studies and collaborations, and was responsible for all intellectual property. Mr. Rangel has filled key roles in a number of other biotechnology companies and worked at Amgen and Hybritech/Lilly early on in his career. Mr. Rangel received a B.A. in chemistry and biochemistry from the University of California, San Diego and an MBA from The Fuqua School of Business at Duke University.

Dr. Webber is Co-founder and SVP of Medicinal Chemistry at Primmune. He brings 33 years of experience in drug discovery in the biotech and pharmaceutical industry. Prior to Primmune, Dr. Webber was Executive Director of Medicinal Chemistry at Polaris Pharmaceuticals where he was responsible for the discovery and synthesis of small molecules against various oncology targets using structure-based drug design. Before joining Polaris, Dr. Webber was a Co-founder and Director of Medicinal Chemistry at eFFECTOR Therapeutics, a company devoted to the discovery and development of translation regulators for cancer. He is a Co-inventor of tomivosertib, an orally active MNK1/2 inhibitor. Previously, Dr. Webber led discovery chemistry efforts at Anadys Pharmaceuticals Inc. where he served at various senior levels until the company was acquired by Roche. His contributions include the discovery of anti-HCV clinical candidates setrobuvir, a non-nucleoside NS5B inhibitor and ANA-773, a second generation orally active TLR-7 agonist prodrug demonstrating antiviral and anticancer activity. Dr. Webber’s career extends back to the inception of Agouron Pharmaceuticals Inc. where he helped pioneer protein crystal structure- and computer-based drug design. Dr. Webber discovered and invented several PARP inhibitors, including Rucaparib (marketed as Rubraca), a FDA approved medicine to treat ovarian cancer in patients with the BRCA, or BRCA-like mutations. Dr. Webber also discovered and co-invented several clinical candidates including nolatrexed dihydrochloride (Thymitaq). He also made significant contributions to the rhinovirus protease project leading to the advancement of ruprintrivir as a clinical candidate. Dr. Webber received his Ph.D. from the University of Pennsylvania and his B.S. from Philadelphia University.

On March 2, 2020 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on emerging immune control mechanisms applicable to inflammation and immuno-oncology indications, reported operating results for the fourth quarter and year ended December 31, 2019 and provided pipeline updates (Press release, AnaptysBio, MAR 2, 2020, View Source [SID1234555042]).

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"We look forward to three Phase 2 clinical trial readouts from our wholly-owned etokimab and ANB019 programs and the expansion of our pipeline with ANB030 and ANB032 during 2020," said Hamza Suria, president and chief executive officer of AnaptysBio. "AnaptysBio is a capital-efficient antibody discovery and development engine that has been validated by the advancement of 7 internally-generated therapeutics to the clinic over the last 4 years, and we look forward to anticipated FDA approval of dostarlimab under our GSK partnership."

Etokimab (ANB020 Anti-IL-33) Program

AnaptysBio is conducting a randomized, placebo-controlled Phase 2 trial in approximately 100 adult patients with chronic rhinosinusitis with nasal polyps, also referred to as the ECLIPSE trial. Patients are being treated with two multi-dosing frequencies of subcutaneously-administered etokimab or placebo, each in combination with mometasone furoate nasal spray as background therapy. The Company anticipates topline data from an interim analysis of the ECLIPSE trial in the first half of 2020.

The Company previously announced data from its ATLAS trial, a Phase 2b randomized, double-blinded, placebo-controlled, multi-dose study in approximately 300 adult patients treated with etokimab in moderate-to-severe atopic dermatitis. Each of the etokimab dosing arms failed to meet the primary endpoint of the trial, which was demonstration of statistically greater improvement in the Eczema Area and Severity Index (EASI) relative placebo at week 16. AnaptysBio has discontinued development of etokimab in moderate-to-severe atopic dermatitis.

The Company has decided to postpone the initiation of its planned Phase 2b etokimab clinical trial in eosinophilic asthma, a multi-dose, randomized, double-blinded, placebo-controlled trial in 300-400 patients, until results are available from the ECLIPSE trial.

ANB019 (Anti-IL-36 Receptor) Program

In September, AnaptysBio announced positive topline data from an interim analysis of its Phase 2 clinical trial of ANB019 monotherapy in moderate-to-severe generalized pustular psoriasis, or GPP, also known as the GALLOP trial. In this interim analysis, both patients achieved the primary endpoint of disease score improvement at Day 29 and Day 113 without requiring rescue therapy, demonstrated rapid and sustained mJDA score improvement, with reduction of 58% at Day 8 and 63% at Day 113, and showed complete clearance of skin pustules by Day 8 and through Day 113, with CRP levels decreasing to nearly normal. Enrollment is ongoing in the GALLOP study, and the Company anticipates additional clinical data and a regulatory strategy update for the development of ANB019 in GPP during 2020.

The Company is also conducting a randomized, placebo-controlled, multi-dose Phase 2 trial in 50 patients with palmoplantar pustulosis, or PPP, also known as the POPLAR trial, with topline data anticipated in the second half of 2020.

AnaptysBio has taken steps to enhance enrollment in the GALLOP and POPLAR trials, including expansion of clinical trial sites and countries.
ANB030 (Anti-PD-1 Agonist) Program

ANB030 is a wholly-owned antibody that binds PD-1 in an agonistic manner, leading to reduced T cell activity and anti-inflammatory effects in vivo. Genetic mutations in the PD-1 pathway are associated with increased susceptibility to various inflammatory conditions and we believe ANB030 has the potential to suppress inflammatory diseases by restoring insufficient PD-1-mediated negative signaling on activated T cells. The Company plans to focus future clinical development of ANB030 on certain autoimmune diseases where PD-1 checkpoint receptor function may be under-represented, submitted an Investigational New Drug Application (IND) in the fourth quarter of 2019 and plans to initiate a Phase 1 clinical trial in the first half of 2020. Preclinical data from the ANB030 was presented in June at the 2019 FOCIS Annual Meeting.
ANB032 (Anti-BTLA Modulator) Program

Our fourth wholly-owned program is an anti-BTLA modulator antibody, known as ANB032, which is broadly applicable to human inflammatory diseases associated with lymphoid and myeloid immune cell dysregulation. Mutations in the BTLA signaling pathway are associated with human inflammatory disease and we believe ANB032 silences pro-inflammatory signaling by modulating BTLA binding to HVEM. We anticipate filing an IND for ANB032 in the second half of 2020.
Dostarlimab (Anti-PD-1 Antagonist) Program Partnered with GSK

GSK has recently announced that a first BLA filing for dostarlimab, an AnaptysBio-generated PD-1 antagonist antibody under partnership with TESARO, a GSK company, occurred in the fourth quarter of 2019 for the treatment of endometrial cancer. AnaptysBio anticipates receiving a $10.0 million cash milestone payment upon acceptance of this BLA filing and a $20.0 million cash milestone upon first FDA approval of dostarlimab. Including additional cash milestones due upon future development and commercialization of dostarlimab, TSR-022, an AnaptysBio-generated TIM-3 antibody, and TSR-033, an AnaptysBio-generated LAG-3 antibody, AnaptysBio can potentially receive a total of $1.1 billion in aggregate milestone payments under this GSK partnership. In addition, AnaptysBio is due a 4% to 8% royalty from GSK, tiered upon global sales, for each of the aforementioned programs.
Board of Directors

In September, the Company appointed Laura J. Hamill to its board of directors. Most recently, Ms. Hamill served as Executive Vice President, Worldwide Commercial Operations, for Gilead Sciences, where she was involved in the strategic direction and long-term planning of the organization. Previously, Ms. Hamill held a number of US and international executive roles at Amgen, culminating with Senior Vice President and General Manager where she led ~$20B in U.S. commercial operations.
Fourth Quarter and Full Year Financial Results

Cash, cash equivalents and investments totaled $428.5 million as of December 31, 2019 compared to $500.2 million as of December 31, 2018, for a decrease of $71.7 million. The decrease relates primarily to cash used for operating activities.

Collaboration revenue was $3.0 million and $8.0 million for the three months and year ended December 31, 2019, which related to a milestone for initiation of a Phase 2 trial for TSR-033, the anti-LAG-3 antibody partnered with TESARO, a GlaxoSmithKline (GSK) company, compared to zero and $5.0 million for the three and year ended December 31, 2018.

Research and development expenses were $21.4 million and $99.3 million for the three months and year ended December 31, 2019, compared to $15.9 million and $56.2 million for the three months and year

ended December 31, 2018. The increase was due primarily to continued advancement of the Company’s etokimab and ANB019 clinical programs and additional personnel-related expenses, including share-based compensation.

General and administrative expenses were $3.8 million and $16.1 million for the three months and year ended December 31, 2019, compared to $3.7 million and $15.5 million for the three months and year ended December 31, 2018. The increase was due primarily to personnel-related expenses, including share-based compensation.

Net loss was $20.3 million and $97.3 million for the three months and year ended December 31, 2019, or a net loss per share of $0.75 and $3.60, compared to a net loss of $17.0 million and $61.7 million for the three months and year ended December 31, 2018, or a net loss per share of $0.64 and $2.50.
Financial Guidance
AnaptysBio expects its net cash burn in 2020 will be approximately $60.0 million, and that its cash, cash equivalents and investments will fund its current operating plan at least into 2023.