On March 7, 2019 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) granted a fifth Breakthrough Therapy Designation (BTD) to venetoclax, for use in combination with obinutuzumab as a fixed duration investigational combination, for untreated adult patients with chronic lymphocytic leukemia (CLL) (Press release, AbbVie, MAR 7, 2019, View Source [SID1234534103]). According to the FDA, this designation is intended to expedite the review of therapies for serious or life-threatening conditions. The designation coincides with the completion of the supplemental New Drug Application (sNDA) submission to the FDA for approval in previously-untreated CLL patients.

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The FDA will review the venetoclax and obinutuzumab combination under its Real-Time Oncology Review (RTOR) pilot program, which aims to explore a more efficient review process to ensure safe and effective cancer medicines are available to patients as early as possible.

"We studied the venetoclax and obinutuzumab combination with a fixed treatment duration and found these medicines, used together, may enable some CLL patients to live longer without their disease getting worse, leading to longer progression-free survival, while remaining off therapy," said Mohamed Zaki, M.D., Ph.D., vice president, global head of hematology development, AbbVie. "Under the RTOR program, we are determined to work with the FDA and bring this first- and only-in-class medicine to previously-untreated CLL patients earlier than expected."

The sNDA for the venetoclax and obinutuzumab combination is based on data from the Phase 3 CLL14 trial, which studied patients receiving the combination treatment for 12 months as their first treatment for CLL. CLL14 is the first randomized trial in CLL to examine a chemotherapy-free, fixed duration treatment regimen.

The FDA’s standard review time for drug applications is six to 10 months.1 The RTOR program focuses on the early submission of data most relevant to assessing the product’s safety and effectiveness. RTOR allows the FDA to review much of the data before it is formally submitted to the FDA.

VENCLEXTA (venetoclax) is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.

About Chronic Lymphocytic Leukemia
CLL is typically a slow-progressing cancer of the bone marrow and blood in which types of white blood cells called B lymphocytes become cancerous and multiply abnormally.2 In the U.S., CLL accounts for more than 20,000 newly diagnosed cases of leukemia each year.2

About the Phase 3 CLL14 Trial
The prospective, multicenter, open-label, randomized Phase 3 CLL14 trial, which was conducted in close collaboration with the German CLL Study Group (DCLLSG), evaluated the efficacy and safety of a combined regimen of venetoclax and obinutuzumab (n=216) versus obinutuzumab and chlorambucil (n=216) in previously-untreated patients with CLL and coexisting medical conditions. The therapies were administered for a fixed duration of 12 months for venetoclax in combination with six cycles of obinutuzumab. The trial enrolled 445 patients, all of whom were previously-untreated according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria. The primary endpoint was progression-free survival (PFS) based on investigator assessment, using iwCLL criteria.3

Key secondary endpoints were PFS as assessed by an independent review committee, minimal residual disease (MRD)-negativity in peripheral blood and bone marrow, overall and complete response rates, MRD-negativity in complete response in peripheral blood and bone marrow, and overall survival.

About VENCLEXTA (venetoclax tablets) (US)
VENCLEXTA is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis. VENCLEXTA targets the BCL-2 protein and works to help restore the process of apoptosis.4

VENCLEXTA is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. Together, the companies are committed to BCL-2 research and to studying venetoclax in clinical trials across several blood and other cancers.

The efficacy and safety of venetoclax in patients with previously-untreated CLL has not been evaluated by the U.S. Food and Drug Administration, the European Medicines Agency or any health authority.

In April 2016, the U.S. FDA first granted accelerated approval of VENCLEXTA for the treatment of patients with CLL with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy.5 The FDA approved this indication under accelerated approval based on overall response rate.5 Based on the results of the MURANO study, VENCLEXTA was approved in June 2018 for the treatment of patients with CLL or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.4 In November 2018, VENCLEXTA was approved in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly-diagnosed acute myeloid leukemia (AML) who are 75 years of age or older, or have other medical conditions that prevent the use of standard chemotherapy.6

Venetoclax is approved in more than 50 countries, including the U.S. AbbVie, in collaboration with Roche, is currently working with regulatory agencies around the world to bring this medicine to additional eligible patients in need.

Uses and Important Safety Information (US)

Uses

VENCLEXTA is a prescription medicine used:

to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior treatment.
in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly-diagnosed acute myeloid leukemia (AML) who:
are 75 years of age or older, or
have other medical conditions that prevent the use of standard chemotherapy.
It is not known if VENCLEXTA is safe and effective in children.

Important Safety Information

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

VENCLEXTA can cause serious side effects, including:

Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and may lead to death. Your healthcare provider will do tests to check your risk of getting TLS before you start taking VENCLEXTA. You will receive other medicines before starting and during treatment with VENCLEXTA to help reduce your risk of TLS. You may also need to receive intravenous (IV) fluids into your vein. Your healthcare provider will do blood tests to check for TLS when you first start treatment and during treatment with VENCLEXTA.

It is important to keep your appointments for blood tests. Tell your healthcare provider right away if you have any symptoms of TLS during treatment with VENCLEXTA, including fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain.

Drink plenty of water when taking VENCLEXTA to help reduce your risk of getting TLS.
Drink 6 to 8 glasses (about 56 ounces total) of water each day, starting 2 days before your first dose, on the day of your first dose of VENCLEXTA, and each time your dose is increased.
Your healthcare provider may delay, decrease your dose, or stop treatment with VENCLEXTA if you have side effects.

Who should not take VENCLEXTA?

Certain medicines must not be taken when you first start taking VENCLEXTA and while your dose is being slowly increased because of the risk of increased TLS.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. VENCLEXTA and other medicines may affect each other, causing serious side effects.
Do not start new medicines during treatment with VENCLEXTA without first talking with your healthcare provider.
Before taking VENCLEXTA, tell your healthcare provider about all of your medical conditions, including if you:

have kidney problems.
have problems with your body salts or electrolytes, such as potassium, phosphorus, or calcium.
have a history of high uric acid levels in your blood or gout.
are scheduled to receive a vaccine. You should not receive a "live vaccine" before, during, or after treatment with VENCLEXTA, until your healthcare provider tells you it is okay. If you are not sure about the type of immunization or vaccine, ask your healthcare provider. These vaccines may not be safe or may not work as well during treatment with VENCLEXTA.
are pregnant or plan to become pregnant. VENCLEXTA may harm your unborn baby. If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with VENCLEXTA, and you should use effective birth control during treatment and for 30 days after the last dose of VENCLEXTA. If you become pregnant or think you are pregnant, tell your healthcare provider right away.
are breastfeeding or plan to breastfeed. It is not known if VENCLEXTA passes into your breast milk. Do not breastfeed during treatment with VENCLEXTA.
What should I avoid while taking VENCLEXTA?
You should not drink grapefruit juice or eat grapefruit, Seville oranges (often used in marmalades), or starfruit while you are taking VENCLEXTA. These products may increase the amount of VENCLEXTA in your blood.

What are the possible side effects of VENCLEXTA?

VENCLEXTA can cause serious side effects, including:

Low white blood cell counts (neutropenia). Low white blood cell counts are common with VENCLEXTA, but can also be severe. Your healthcare provider will do blood tests to check your blood counts during treatment with VENCLEXTA. Tell your healthcare provider right away if you have a fever or any signs of an infection during treatment with VENCLEXTA.
The most common side effects of VENCLEXTA when used in combination with rituximab in people with CLL include low white blood cell counts, diarrhea, upper respiratory tract infection, cough, tiredness, and nausea.

The most common side effects of VENCLEXTA when used alone in people with CLL/SLL include low white blood cell counts; diarrhea; nausea; upper respiratory tract infection; low red blood cell counts; tiredness; low platelet counts; muscle and joint pain; swelling of your arms, legs, hands, and feet; and cough.

The most common side effects of VENCLEXTA in combination with azacitidine, or decitabine, or low-dose cytarabine in people with AML include low white blood cell counts; nausea; diarrhea; low platelet counts; constipation; fever with low white blood cell counts; low red blood cell counts, infection in blood; rash; dizziness; low blood pressure; fever; swelling of your arms, legs, hands, and feet; vomiting; tiredness; shortness of breath; bleeding; infection in lung; stomach (abdominal) pain; pain in muscles or back; cough; and sore throat.

VENCLEXTA may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of VENCLEXTA. For more information, ask your healthcare provider or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit View Source or call 1-800-FDA-1088.

If you cannot afford your medication, contact: www.pparx.org for assistance.

The full U.S. prescribing information, including Medication Guide, for VENCLEXTA can be found here. Globally, prescribing information varies; refer to the individual country product label for complete information.

About AbbVie in Oncology
At AbbVie, we strive to discover and develop medicines that deliver transformational improvements in cancer treatment by uniquely combining our deep knowledge in core areas of biology with cutting-edge technologies, and by working together with our partners – scientists, clinical experts, industry peers, advocates, and patients. We remain focused on delivering these transformative advances in treatment across some of the most debilitating and widespread cancers. We are also committed to exploring solutions to help patients obtain access to our cancer medicines. With the acquisitions of Pharmacyclics in 2015 and Stemcentrx in 2016, our research and development efforts, and through collaborations, AbbVie’s oncology portfolio now consists of marketed medicines and a pipeline containing multiple new molecules being evaluated worldwide in more than 200 clinical trials and more than 20 different tumor types. For more information, please visit View Source

On March 7, 2019 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical stage biotechnology company focused on discovering and developing novel small molecule drugs for the treatment of cancer and other life-threatening diseases, reported its financial results for the fourth quarter and year ended December 31, 2018 (Press release, Calithera Biosciences, MAR 7, 2019, View Source [SID1234534102]). As of December 31, 2018, cash, cash equivalents and investments totaled $136.2 million.

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"This is a time of significant progress for Calithera’s clinical development program as we continue to advance our novel onco-metabolism clinical candidates through robust clinical studies," said Susan M. Molineaux, PhD, president and chief executive officer of Calithera. "In the fourth quarter, we broadened development of the novel glutaminase inhibitor telaglenastat through two new clinical trial collaborations with Pfizer. We recently completed enrollment of the ENTRATA trial of telaglenastat for the treatment of patients with renal cell carcinoma. We anticipate that this momentum will continue in 2019 with data from the ENTRATA trial and, with our partner Incyte, data from the INCB001158 program, both expected in the second half of the year."

Fourth Quarter 2018 and Recent Highlights

Completed patient enrollment in the randomized phase 2 ENTRATA trial of telaglenastat (CB-839) and everolimus in renal cell carcinoma (RCC). The ENTRATA trial (NCT03163667) is a Phase 2 randomized, double-blind trial designed to evaluate the safety and efficacy of telaglenastat in combination with everolimus versus placebo with everolimus in patients with advanced clear cell RCC who have been treated with at least two prior lines of systemic therapy, including a VEGFR-targeted tyrosine kinase inhibitor. The trial enrolled 69 patients at multiple centers in the United States. The primary endpoint of ENTRATA is progression-free survival (PFS). Calithera plans to report efficacy and safety data from the trial in the second half of 2019.

Announced two new clinical trial collaborations to evaluate Pfizer’s CDK4/6 inhibitor palbociclib, also known as IBRANCE, and the dual-mechanism poly (ADP-ribose) polymerase (PARP) inhibitor talazoparib also known as TALZENNA, each in combination with Calithera’s glutaminase inhibitor telaglenastat. Preclinical data suggest that telaglenastat synergizes with PARP inhibitors to impair DNA synthesis, enhance DNA damage, and block cancer cell proliferation. Calithera will initiate a Phase 1/2 clinical trial of the combination of telaglenastat plus talazoparib in patients with RCC and TNBC in the first quarter of 2019. Telaglenastat also synergizes with CDK4/6 inhibitors by enhancing cell cycle arrest and blocking cancer cell proliferation. Calithera will initiate a Phase 1/2 clinical trial of the combination of telaglenastat plus palbociclib in patients with KRAS-mutated colorectal cancer (CRC) and patients with KRAS-mutated non-small cell lung cancer (NSCLC) in the second quarter of 2019.

Advanced INCB001158 arginase inhibitor immuno-oncology program. INCB001158 is being evaluated in multiple clinical trials for the treatment of patients with cancer both as a monotherapy, and in combination with immunotherapies and chemotherapy. INCB001158 is being developed as part of a collaboration and license agreement with Incyte. Data from the INCB001158 program are expected to be presented at a medical meeting in the second half of 2019.

Initiated Phase 1 trial of arginase inhibitor CB-280 for the treatment of cystic fibrosis. Arginase is believed to be critical in the pathology of cystic fibrosis. It impairs production of nitric oxide and generates metabolites of arginine that may impair lung function. CB-280 is an orally administered small molecule inhibitor of arginase. The first-in-human Phase 1 trial initiated in February 2019 will evaluate the safety, tolerability and pharmacokinetic profile of oral CB-280 in healthy volunteers. The study will be conducted under a United States Food and Drug Administration (FDA) Investigational New Drug (IND) application.

Initiated IND-enabling studies with CB-708, an oral small molecule CD73 inhibitor. The immuno-oncology target CD73 is an enzyme that plays a critical role in the process of ATP conversion to adenosine. Initiation of a Phase 1 study of CB-708, an orally administered small molecule inhibitor of CD73, is planned for 2019. A preclinical abstract describing CB-708 has been accepted for presentation at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in March.

Selected Fourth Quarter 2018 Financial Results

Cash, cash equivalents and investments totaled $136.2 million at December 31, 2018.

Collaboration revenue for the full year 2018 was $22.2 million, compared with $26.0 million in the prior year. In June 2018, we completed the manufacturing services and technology transfer under our collaboration and license agreement with Incyte, which satisfied the performance obligation under ASC 606, and as a result, all remaining deferred revenue was recognized.

Research and development expenses for the full year 2018 were $66.2 million, compared with $43.1 million in the prior year. The increase of $23.1 million was due to an increase in the telaglenastat program to support our new and ongoing clinical trials, including for our Phase 2 CANTATA trial which opened in 2018, increases in the INCB001158 and CB-280 programs, as well as investment in early stage research. Research and development expenses for the fourth quarter of 2018 were $17.0 million, compared to $15.5 million for the same period last year.

General and administrative expenses for the full year 2018 were $13.3 million, compared with $12.5 million in the prior year. The increase of $0.8 million in 2018 was primarily due to higher personnel-related costs to support our clinical trials, offset partially by lower outside professional services, including activities related to our Incyte collaboration and license agreement and sublease in 2017. General and administrative expenses for the fourth quarter of 2018 were $3.2 million, compared to $3.3 million for the same period last year.

Interest Income, net for the full year 2018 was $2.7 million, compared with $1.9 million in the prior year. The increase of $0.8 million related to higher returns on our investments, partially offset by lower cash equivalents and investment balances. Interest income, net for the fourth quarter of 2018 was $0.7 million, compared to $0.6 million for the same period last year.

Net loss from operations for the three months and year ended December 31, 2018 was $19.5 million and $54.6 million, respectively.

Conference Call Information

Calithera will host an update conference call today, Thursday, March 7th at 4:30 p.m. Eastern Time/ 1:30 p.m. Pacific Time. The call may be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 (international), and referring to conference ID 9577446. To access the live audio webcast or the subsequent archived recording, visit the Investors section of the Calithera website at www.calithera.com. The webcast will be recorded and available for replay on Calithera’s website for 30 days.

On March 7, 2019 Cytori Therapeutics, Inc. (NASDAQ: CYTX) reported that it officially filed a formal new drug application pre-submission request to the European Medicine Agency (EMA) for Doxorubicin Hydrochloride Cytori (Press release, Cytori Therapeutics, MAR 7, 2019, View Source [SID1234534097]). This submission is the precursor to filing an Article 58 Application for a Marketing Authorization Application (MAA) via EMA’s centralized approval procedure. In June 2017, the EMA Committee for Medicinal Products for Human Use (CHMP) confirmed that Doxorubicin Hydrochloride Cytori was eligible for submission of a MAA via the centralized procedure.

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In addition, in late 2018, the EMA CHMP Name Review Group validated Doxorubicin Hydrochloride Cytori as the official invented name to replace ATI-0918. Doxorubicin Hydrochloride Cytori is a liposomal nanoparticle medicinal product being developed for cancer patients that contains the active substance doxorubicin, a widely used chemotherapy drug. Doxorubicin Hydrochloride Cytori is intended for the treatment of breast cancer, ovarian cancer, multiple myeloma, and Kaposi’s sarcoma.

"Liposomal doxorubicin is a commonly prescribed chemotherapeutic drug for patients with advanced breast and ovarian cancer as well as other indications," said Dr. Marc Hedrick MD, President/CEO of Cytori Therapeutics. "Bringing Doxorubicin Hydrochloride Cytori to market in Europe as an alternative to the branded drug is an important near-term corporate goal."

As a ‘hybrid medicine’, Doxorubicin Hydrochloride Cytori is intended to be similar to a ‘reference medicine’, Adriamycin, already authorized in the EU. Doxorubicin Hydrochloride Cytori is different than Adriamycin in that the active substance is encapsulated in tiny lipid nanospheres called liposomes that are coated in polyethylene glycol or PEG. Cytori believes that it has successfully completed all clinical development work for Doxorubicin Hydrochloride Cytori and is currently manufacturing the drug in its dedicated plant in San Antonio, Texas.

Cytori expects to receive assignment of a rapporteur and co-rapporteur, who will work with the company through the MAA submission and review process, by the end of April 2019. The MAA submission is planned for later in 2019 or early 2020.

Cytori’s MAA will present data from the scientific literature and from non-clinical studies, including comparisons with Janssen’s Caelyx, an authorized medicine containing doxorubicin in pegylated liposomal form. The company will also present the results of a completed clinical study intended to investigate whether Doxorubicin Hydrochloride Cytori is ‘bioequivalent’ to Caelyx, meaning that they both produce the same levels of the active substance in the body.

Janssen’s Caelyx first received a marketing authorization for the EU in 1996, is currently approved for the treatment of breast cancer, ovarian cancer, multiple myeloma, and Kaposi’s sarcoma, and generated over €110M in sales across Europe in 2017. No generic versions of Caelyx are currently approved and available in Europe.

On March 7, 2019 GlycoMimetics, Inc. (Nasdaq: GLYC) reported that Chief Executive Officer Rachel King will provide a company overview at the Cowen and Company 39th Annual Health Care Conference in Boston, on Tuesday, March 12, 2019, at 9:20 a.m. ET (Press release, GlycoMimetics, MAR 7, 2019, https://ir.glycomimetics.com/news-releases/news-release-details/glycomimetics-present-cowen-and-company-39th-annual-health-care [SID1234534096]).

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To access the live webcast and subsequent archived recordings for the presentation, please visit the GlycoMimetics website at www.glycomimetics.com.

On March 7, 2019 Surface Oncology (NASDAQ:SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported financial results and corporate highlights for the fourth quarter and full year 2018, as well as anticipated corporate milestones for 2019 (Press release, Surface Oncology, MAR 7, 2019, View Source [SID1234534095]).

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"At Surface we strive to break through and deliver on the promise of next generation immunotherapies to create a meaningful impact on patients’ lives," said Jeff Goater, chief executive officer of Surface Oncology. "2018 was a landmark year for the company as two of our products advanced into phase 1 clinical development and we successfully completed our IPO. With three wholly-owned product candidates either in, or approaching the clinic, and a strong balance sheet, we remain focused on execution across all fronts. Our team of Surfers is ready for, and excited about, the road ahead."

Recent Corporate Highlights:

Continued dose escalation for the phase 1 trial of NZV930 (CD73), with trial sites now recruiting in four countries

Initiation of IND-enabling studies for SRF617 (CD39) and SRF388 (IL-27)

Retention of worldwide rights for SRF388, a first-in-class antibody targeting IL-27

Publication in ImmunoHorizons of research highlighting the role of IL-27 in the upregulation of multiple checkpoint proteins

Deprioritization of SRF231 (CD47) clinical program based upon dose escalation data and competitive landscape

Appointment of F. Stephen Hodi, MD to the Scientific Advisory Board

Promotion of Jessica Fees to senior vice president, finance and business operations

Addition of Surface Oncology to the NASDAQ Biotechnology Index

Selected Anticipated 2019 Corporate Milestones:

Presentation at the Brisbane Immunotherapy Conference, highlighting recent discoveries in tumor microenvironment biology in May 2019

IND filing for SRF617 in Q4 2019

IND filing for SRF388 in Q4 2019

Introduction of new program and clinical candidate in Q4 2019

Inaugural Surface Oncology Investor and Analyst Day in New York City, Q4 2019

Additional findings and learnings related to the deprioritization of SRF231 in H2 2019

Financial Results:

As of December 31, 2018, cash, cash equivalents and marketable securities were $158.8 million, compared to $63.3 million on December 31, 2017. This increase was due to the $108.7 million in net proceeds from Surface’s initial public offering and concurrent private placement completed in April 2018 and receipt of a $45.0 million milestone payment from Novartis related to NZV930, offset by operating costs during the year.

Research and development (R&D) expenses were $10.5 million for the fourth quarter ended December 31, 2018, compared to $16.3 million for the same period in 2017. The decrease was primarily driven by a reduction in costs associated with the SRF231 program, in accordance with the deprioritization of the program in the fourth quarter of 2018. R&D expenses were $52.5 million for the full year 2018, compared to $47.8 million for the same period in 2017. The increase was primarily driven by expenditures associated with Surface’s advancing product pipeline as well as increased R&D personnel costs associated with the growth of the company. R&D expenses included $2.5 million in stock-based compensation expenses for the full year 2018.

General and administrative (G&A) expenses were $4.8 million for the fourth quarter ended December 31, 2018, compared to $2.8 million for the same period in 2017. G&A expenses were $16.1 million for the full year 2018, compared to $11.0 million for the same period in 2017. The increase in G&A expenses for both the fourth quarter of 2018 and the full year 2019 was primarily due to increased personnel costs and professional fees associated with the growth of the company and operating as a public company. G&A expenses included $2.7 million in stock-based compensation expenses for the full year 2018.

For the fourth quarter ended December 31, 2018, net loss was $4.7 million, or basic and diluted net loss per share attributable to common stockholders of $0.17. Net loss was $15.8 million for the same period in 2017, or basic and diluted net loss per share attributable to common stockholders of $6.16. For the full year ended December 31, 2018, net loss was $6.6 million, or basic and diluted net loss per share attributable to common stockholders of $0.33. Net loss was $45.4 million for the same period in 2017, or basic and diluted net loss per share attributable to common stockholders of $18.35.

Financial Outlook:

Based upon its current operating plan, Surface continues to have a projected cash runway through 2021.